Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2020

 
CONTENT
Federal Register, Volume 84 Issue 152 (Wednesday, August 7, 2019)
[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Rules and Regulations]
[Pages 38728-38833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16485]
[[Page 38727]]
Vol. 84
Wednesday,
No. 152
August 7, 2019
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 409 and 413
Medicare Program; Prospective Payment System and Consolidated Billing
for Skilled Nursing Facilities; Updates to the Quality Reporting
Program and Value-Based Purchasing Program for Federal Fiscal Year
2020; Final Rule
Federal Register / Vol. 84 , No. 152 / Wednesday, August 7, 2019 /
Rules and Regulations
[[Page 38728]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409 and 413
[CMS-1718-F]
RIN 0938-AT75
Medicare Program; Prospective Payment System and Consolidated
Billing for Skilled Nursing Facilities; Updates to the Quality
Reporting Program and Value-Based Purchasing Program for Federal Fiscal
Year 2020
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule updates the payment rates used under the
prospective payment system (PPS) for skilled nursing facilities (SNFs)
for fiscal year (FY) 2020. We also are making minor revisions to the
regulation text to reflect the revised assessment schedule under the
Patient Driven Payment Model (PDPM). Additionally, we are revising the
definition of group therapy under the SNF PPS, and are implementing a
subregulatory process for updating the code lists (International
Classification of Diseases, Tenth Version (ICD-10) codes) used under
PDPM. In addition, the final rule updates requirements for the SNF
Quality Reporting Program (QRP) and the SNF Value-Based Purchasing
(VBP) Program.
DATES: These regulations are effective on October 1, 2019.
FOR FURTHER INFORMATION CONTACT:
    Penny Gershman, (410) 786-6643, for information related to SNF PPS
clinical issues.
    Anthony Hodge, (410) 786-6645, for information related to payment
for SNF-level swing-bed services.
    John Kane, (410) 786-0557, for information related to the
development of the payment rates and case-mix indexes, and general
information.
    Kia Sidbury, (410) 786-7816, for information related to the wage
index.
    Bill Ullman, (410) 786-5667, for information related to level of
care determinations and consolidated billing.
    Casey Freeman, (410) 786-4354, for information related to the
skilled nursing facility quality reporting program.
    Lang Le, (410) 786-5693, for information related to the skilled
nursing facility value-based purchasing program.
SUPPLEMENTARY INFORMATION:
Availability of Certain Tables Exclusively Through the Internet on the
CMS Website
    As discussed in the FY 2014 SNF PPS final rule (78 FR 47936),
tables setting forth the Wage Index for Urban Areas Based on CBSA Labor
Market Areas and the Wage Index Based on CBSA Labor Market Areas for
Rural Areas are no longer published in the Federal Register. Instead,
these tables are available exclusively through the internet on the CMS
website. The wage index tables for this final rule can be accessed on
the SNF PPS Wage Index home page, at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
    Readers who experience any problems accessing any of these online
SNF PPS wage index tables should contact Kia Sidbury at (410) 786-7816.
I. Executive Summary
A. Purpose
    This final rule updates the SNF prospective payment rates for
fiscal year (FY) 2020 as required under section 1888(e)(4)(E) of the
Social Security Act (the Act). It also responds to section
1888(e)(4)(H) of the Act, which requires the Secretary to provide for
publication of certain specified information relating to the payment
update (see section II.C. of this final rule) in the Federal Register,
before the August 1 that precedes the start of each FY. This final rule
also revises the definition of group therapy under the SNF PPS and
implements a subregulatory process for updating ICD-10 code lists used
under the PDPM. Finally, this rule updates requirements for the Skilled
Nursing Facility Quality Reporting Program (SNF QRP) and Skilled
Nursing Facility Value-Based Purchasing Program (SNF VBP).
B. Summary of Major Provisions
    In accordance with sections 1888(e)(4)(E)(ii)(IV) and (e)(5) of the
Act, the federal rates in this final rule reflect an update to the
rates that we published in the SNF PPS final rule for FY 2019 (83 FR
39162), as corrected in the FY 2019 SNF PPS correction notice (83 FR
49832), which reflects the SNF market basket update, as adjusted by the
multifactor productivity (MFP) adjustment, for FY 2020. In addition, we
are revising the definition of group therapy under the SNF PPS and
implementing a subregulatory process for updating ICD-10 code lists
used under the PDPM.
    This final rule updates requirements for the SNF QRP, including the
adoption of two Transfer of Health Information quality measures and
standardized patient assessment data elements that SNFs would be
required to begin reporting with respect to admissions and discharges
that occur on or after October 1, 2020. We also are finalizing our
proposal to exclude baseline nursing home residents from the Discharge
to Community Measure. Further, we also are finalizing our proposal to
publicly display the quality measure, Drug Regimen Review Conducted
With Follow-Up for Identified Issues-Post Acute Care (PAC) Skilled
Nursing Facility (SNF) Quality Reporting Program (QRP). We also are
finalizing our proposal to revise references in the regulations text to
reflect enhancements to the system used for the submission of data.
Finally, we requested information on quality measures and standardized
resident assessment data elements under consideration for future years,
and we have summarized the information we received. In contrast, we are
not finalizing our proposal to expand data collection for SNF QRP
quality measures to all SNF residents, regardless of their payer.
    In accordance with section 1888(h) of the Act, this rule updates
certain policies for the SNF VBP Program.
C. Summary of Cost and Benefits
                       Table 1--Cost and Benefits
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    Provision description                   Total transfers
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FY 2020 SNF PPS payment rate   The overall economic impact of this final
 update.                        rule is an estimated increase of $851
                                million in aggregate payments to SNFs
                                during FY 2020.
FY 2020 Updates to the SNF     The overall annual cost for SNFs to
 QRP.                           submit data for the SNF QRP for the
                                provisions in this final rule is $29
                                million.
FY 2020 SNF VBP changes......  The overall economic impact of the SNF
                                VBP Program is an estimated reduction of
                                $213.6 million in aggregate payments to
                                SNFs during FY 2020.
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[[Page 38729]]
D. Advancing Health Information Exchange
    The Department of Health and Human Services (HHS) has a number of
initiatives designed to encourage and support the adoption of
interoperable health information technology and to promote nationwide
health information exchange to improve health care. The Office of the
National Coordinator for Health Information Technology (ONC) and CMS
work collaboratively to advance interoperability across settings of
care, including post-acute care.
    To further interoperability in post-acute care, we developed a Data
Element Library (DEL) to serve as a publicly available centralized,
authoritative resource for standardized data elements and their
associated mappings to health IT standards. The DEL furthers CMS' goal
of data standardization and interoperability. These interoperable data
elements can reduce provider burden by allowing the use and exchange of
healthcare data, support provider exchange of electronic health
information for care coordination, person-centered care, and support
real-time, data driven, clinical decision making. Standards in the DEL
(https://del.cms.gov/) can be referenced on the CMS website and in the
ONC Interoperability Standards Advisory (ISA). The 2019 ISA is
available at https://www.healthit.gov/isa.
    The 21st Century Cures Act (the Cures Act) (Pub. L. 114-255,
enacted December 13, 2016) requires HHS to take new steps to enable the
electronic sharing of health information ensuring interoperability for
providers and settings across the care continuum. In another important
provision, Congress defined ``information blocking'' as practices
likely to interfere with, prevent, or materially discourage access,
exchange, or use of electronic health information, and established new
authority for HHS to discourage these practices. In March 2019, ONC and
CMS published the proposed rules, ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program,'' (84 FR 7424) and ``Interoperability and
Patient Access'' (84 FR 7610) to promote secure and more immediate
access to health information for patients and healthcare providers
through the implementation of information blocking provisions of the
Cures Act and the use of standardized application programming
interfaces (APIs) that enable easier access to electronic health
information. These two rules were open for public comment at
www.regulations.gov. We invited providers to learn more about these
important developments and how they are likely to affect SNFs.
II. Background on SNF PPS
A. Statutory Basis and Scope
    As amended by section 4432 of the Balanced Budget Act of 1997 (BBA
1997) (Pub. L. 105-33, enacted August 5, 1997), section 1888(e) of the
Act provides for the implementation of a PPS for SNFs. This methodology
uses prospective, case-mix adjusted per diem payment rates applicable
to all covered SNF services defined in section 1888(e)(2)(A) of the
Act. The SNF PPS is effective for cost reporting periods beginning on
or after July 1, 1998, and covers all costs of furnishing covered SNF
services (routine, ancillary, and capital-related costs) other than
costs associated with approved educational activities and bad debts.
Under section 1888(e)(2)(A)(i) of the Act, covered SNF services include
post-hospital extended care services for which benefits are provided
under Part A, as well as those items and services (other than a small
number of excluded services, such as physicians' services) for which
payment may otherwise be made under Part B and which are furnished to
Medicare beneficiaries who are residents in a SNF during a covered Part
A stay. A comprehensive discussion of these provisions appears in the
May 12, 1998 interim final rule (63 FR 26252). In addition, a detailed
discussion of the legislative history of the SNF PPS is available
online at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Legislative_History_2018-10-01.pdf.
    Section 215(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, enacted April 1, 2014) added section 1888(g) to
the Act requiring the Secretary to specify an all-cause all-condition
hospital readmission measure and an all-condition risk-adjusted
potentially preventable hospital readmission measure for the SNF
setting. Additionally, section 215(b) of PAMA added section 1888(h) to
the Act requiring the Secretary to implement a VBP program for SNFs.
Finally, section 2(c)(4) of the IMPACT Act amended section 1888(e)(6)
of the Act, which requires the Secretary to implement a QRP for SNFs
under which SNFs report data on measures and resident assessment data.
B. Initial Transition for the SNF PPS
    Under sections 1888(e)(1)(A) and (e)(11) of the Act, the SNF PPS
included an initial, three-phase transition that blended a facility-
specific rate (reflecting the individual facility's historical cost
experience) with the federal case-mix adjusted rate. The transition
extended through the facility's first 3 cost reporting periods under
the PPS, up to and including the one that began in FY 2001. Thus, the
SNF PPS is no longer operating under the transition, as all facilities
have been paid at the full federal rate effective with cost reporting
periods beginning in FY 2002. As we now base payments for SNFs entirely
on the adjusted federal per diem rates, we no longer include adjustment
factors under the transition related to facility-specific rates for the
upcoming FY.
C. Required Annual Rate Updates
    Section 1888(e)(4)(E) of the Act requires the SNF PPS payment rates
to be updated annually. The most recent annual update occurred in a
final rule that set forth updates to the SNF PPS payment rates for FY
2019 (83 FR 39162), as corrected in the FY 2019 SNF PPS correction
notice (83 FR 49832).
    Section 1888(e)(4)(H) of the Act specifies that we provide for
publication annually in the Federal Register of the following:
     The unadjusted federal per diem rates to be applied to
days of covered SNF services furnished during the upcoming FY.
     The case-mix classification system to be applied for these
services during the upcoming FY.
     The factors to be applied in making the area wage
adjustment for these services.
    Along with other revisions discussed later in this preamble, this
final rule will provide the required annual updates to the per diem
payment rates for SNFs for FY 2020.
III. Analysis and Responses to Public Comments on the FY 2020 SNF PPS
Proposed Rule
    In response to the publication of the FY 2020 SNF PPS proposed
rule, we received 63 public comments from individuals, providers,
corporations, government agencies, private citizens, trade
associations, and major organizations. The following are brief
summaries of each proposed provision, a summary of the public comments
that we received related to that proposal, and our responses to the
comments.
A. General Comments on the FY 2020 SNF PPS Proposed Rule
    In addition to the comments we received on specific proposals
contained within the proposed rule (which we address later in this
final rule), commenters also submitted the
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following, more general, observations on the SNF PPS and SNF care
generally, as well as on aspects of PDPM that were finalized in the FY
2019 SNF PPS final rule. A discussion of these comments, along with our
responses, appears below.
    Comment: Many commenters expressed their continued support for
implementation of PDPM. Many commenters also offered suggestions and
recommendations for how to improve aspects of PDPM finalized in the FY
2019 SNF PPS final rule. Several commenters raised concerns regarding
the impact of PDPM on other payers, such as on Medicare Advantage plans
and on Medicaid programs, as well as on other CMS payment models, such
as the Bundled Payment for Care Initiative and Accountable Care
Organizations. A few commenters requested clarification on how PDPM
would align with a unified post-acute payment system. Finally, several
commenters raised concerns with certain structural elements of PDPM
finalized in the FY 2019 final rule, such as the data used in
developing the case-mix indexes under PDPM, the use of section GG on
the MDS, and the effect of the variable per diem adjustment,
specifically that used under the NTA component, on care provision.
    Response: We appreciate all of the comments we received supporting
PDPM implementation. We also appreciate all of the comments and
suggestions on ways to improve PDPM in the future, including comments
regarding changes in the structural elements of PDPM, such as the
variable per diem adjustment or use of section GG on the MDS. However,
because we consider these comments to be outside the scope of the
current rulemaking, we are not addressing them in this final rule. We
will consider all of these recommendations as we consider future
rulemaking.
    For comments on the impact of PDPM on other payers, we have worked
with each of these groups to provide education and training to aid in
understanding the impact of PDPM implementation on the respective
group. Most notably, we have worked closely with states to aid in
navigating the transition to PDPM, while maintaining support for legacy
case-mix systems necessary for certain state Medicaid programs. With
regard to the impact of PDPM on alternative payment models, we have
worked with the teams responsible for these policies to provide
education on how PDPM changes payment under the SNF PPS and will ensure
that evaluating the impact of PDPM on these models is a component of
our monitoring program after implementation.
    In terms of how PDPM would align with a unified post-acute payment
system, we believe that PDPM represents an important step in aligning
the SNF PPS with other post-acute payment systems, in anticipation of a
unified post-acute payment system. Many of the aspects of PDPM
finalized in the FY 2019 final rule, such as the use of patient
characteristics as the basis for payment, and our revision in this
final rule to the definition of group therapy (as discussed in section
III.D.1. of this final rule), better align SNF PPS payment policies
with those used in other post-acute settings.
    Comment: Many commenters suggested that CMS monitor closely the
financial, clinical, and outcome-related impacts of PDPM
implementation. Several commenters requested clarification on
contingency plans in case of assessment and/or claims submission and
processing errors in the early stages of PDPM implementation. A few
commenters requested that CMS consider convening a stakeholder
workgroup to review data derived from the aforementioned monitoring
activities and consider ways of sharing the data collected with
stakeholders.
    Response: We agree with commenters that close, real-time monitoring
will be essential once PDPM is implemented. We are developing a robust
monitoring program that will incorporate data from patient assessments,
claims, cost reports, and quality measurement programs to identify any
adverse or positive trends associated with PDPM implementation. With
respect to sharing this data or convening a stakeholder workgroup, we
are still in the process of determining the best way to share the data
collected during our monitoring activities and the best way to engage
with stakeholders to ensure a collective understanding of the data
collected.
    Regarding contingency plans for any issues in assessment or claims
submission and/or processing after PDPM is implemented, CMS and its
contractors intend to put adequate risk mitigation strategies in place
to identify potential risk areas pre-emptively and ensure adequate
testing to eliminate such risk. If any issues are identified after PDPM
is implemented, we request that stakeholders alert us as soon as
possible, so that the issue can be addressed.
    Comment: A few commenters requested that CMS finalize the Revisions
to Requirements for Discharge Planning for Hospitals, Critical Access
Hospitals, and Home Health Agencies proposed rule (80 FR 68126-68155),
to ensure that hospitals provide SNFs with the necessary medical
records and documentation used for both care planning and coding
purposes in as timely a manner as possible. These commenters stated
that the lack of such information represents a potentially serious
program risk, as they often do not have the hospital information in as
timely a manner as necessary for capturing such information on the MDS.
    Response: We appreciate this comment and have shared with the
appropriate CMS staff responsible for the proposed rule referenced
above.
B. SNF PPS Rate Setting Methodology and FY 2020 Update
1. Federal Base Rates
    Under section 1888(e)(4) of the Act, the SNF PPS uses per diem
federal payment rates based on mean SNF costs in a base year (FY 1995)
updated for inflation to the first effective period of the PPS. We
developed the federal payment rates using allowable costs from
hospital-based and freestanding SNF cost reports for reporting periods
beginning in FY 1995. The data used in developing the federal rates
also incorporated a Part B add-on, which is an estimate of the amounts
that, prior to the SNF PPS, would be payable under Part B for covered
SNF services furnished to individuals during the course of a covered
Part A stay in a SNF.
    In developing the rates for the initial period, we updated costs to
the first effective year of the PPS (the 15-month period beginning July
1, 1998) using a SNF market basket index, and then standardized for
geographic variations in wages and for the costs of facility
differences in case mix. In compiling the database used to compute the
federal payment rates, we excluded those providers that received new
provider exemptions from the routine cost limits, as well as costs
related to payments for exceptions to the routine cost limits. Using
the formula that the BBA 1997 prescribed, we set the federal rates at a
level equal to the weighted mean of freestanding costs plus 50 percent
of the difference between the freestanding mean and weighted mean of
all SNF costs (hospital-based and freestanding) combined. We computed
and applied separately the payment rates for facilities located in
urban and rural areas, and adjusted the portion of the federal rate
attributable to wage-related costs by a wage index to reflect
geographic variations in wages.
[[Page 38731]]
2. SNF Market Basket Update
a. SNF Market Basket Index
    Section 1888(e)(5)(A) of the Act requires us to establish a SNF
market basket index that reflects changes over time in the prices of an
appropriate mix of goods and services included in covered SNF services.
Accordingly, we have developed a SNF market basket index that
encompasses the most commonly used cost categories for SNF routine
services, ancillary services, and capital-related expenses. In the SNF
PPS final rule for FY 2018 (82 FR 36548 through 36566), we revised and
rebased the market basket index, which included updating the base year
from FY 2010 to 2014.
    The SNF market basket index is used to compute the market basket
percentage change that is used to update the SNF federal rates on an
annual basis, as required by section 1888(e)(4)(E)(ii)(IV) of the Act.
This market basket percentage update is adjusted by a forecast error
correction, if applicable, and then further adjusted by the application
of a productivity adjustment as required by section 1888(e)(5)(B)(ii)
of the Act and described in section III.B.2.d. of this final rule. For
the FY 2020 proposed rule, the growth rate of the 2014-based SNF market
basket was estimated to be 3.0 percent, based on the IHS Global
Insight, Inc. (IGI) first quarter 2019 forecast with historical data
through fourth quarter 2018, before the multifactor productivity
adjustment is applied. However, as discussed in the FY 2020 proposed
rule (84 FR 17624), our policy is that if more recent data become
available (for example, a more recent estimate of the 2014-based SNF
market basket or MFP adjustment), we would use such data, if
appropriate, to determine the FY 2020 SNF market basket percentage
change, labor-related share relative importance, forecast error
adjustment, and MFP adjustment in the SNF PPS final rule. Since the
proposed rule, we have updated the FY 2020 market basket percentage
increase based on the IGI second quarter 2019 forecast, with historical
data through first quarter 2019. The revised SNF market basket growth
rate based on this updated data is 2.8 percent.
    In section III.B.2.e. of this final rule, we discuss the 2 percent
reduction applied to the market basket update for those SNFs that fail
to submit measures data as required by section 1888(e)(6)(A) of the
Act.
b. Use of the SNF Market Basket Percentage
    Section 1888(e)(5)(B) of the Act defines the SNF market basket
percentage as the percentage change in the SNF market basket index from
the midpoint of the previous FY to the midpoint of the current FY. For
the federal rates set forth in this final rule, we use the percentage
change in the SNF market basket index to compute the update factor for
FY 2020. This factor is based on the FY 2020 percentage increase in the
2014-based SNF market basket index reflecting routine, ancillary, and
capital-related expenses. In this final rule, the SNF market basket
percentage is estimated to be 2.8 percent for FY 2020 based on IGI's
second quarter 2019 forecast (with historical data through first
quarter 2019). Finally, as discussed in section II.B.2. of this final
rule, we no longer compute update factors to adjust a facility-specific
portion of the SNF PPS rates, because the initial three-phase
transition period from facility-specific to full federal rates that
started with cost reporting periods beginning in July 1998 has expired.
c. Forecast Error Adjustment
    As discussed in the June 10, 2003 supplemental proposed rule (68 FR
34768) and finalized in the August 4, 2003 final rule (68 FR 46057
through 46059), Sec.  413.337(d)(2) provides for an adjustment to
account for market basket forecast error. The initial adjustment for
market basket forecast error applied to the update of the FY 2003 rate
for FY 2004, and took into account the cumulative forecast error for
the period from FY 2000 through FY 2002, resulting in an increase of
3.26 percent to the FY 2004 update. Subsequent adjustments in
succeeding FYs take into account the forecast error from the most
recently available FY for which there is final data, and apply the
difference between the forecasted and actual change in the market
basket when the difference exceeds a specified threshold. We originally
used a 0.25 percentage point threshold for this purpose; however, for
the reasons specified in the FY 2008 SNF PPS final rule (72 FR 43425,
August 3, 2007), we adopted a 0.5 percentage point threshold effective
for FY 2008 and subsequent FYs. As we stated in the final rule for FY
2004 that first issued the market basket forecast error adjustment (68
FR 46058, August 4, 2003), the adjustment will reflect both upward and
downward adjustments, as appropriate.
    For FY 2018 (the most recently available FY for which there is
final data), the estimated increase in the market basket index was 2.6
percentage points, and the actual increase for FY 2018 is 2.6
percentage points, resulting in the actual increase being the same as
the estimated increase. Accordingly, as the difference between the
estimated and actual amount of change in the market basket index does
not exceed the 0.5 percentage point threshold, the FY 2020 market
basket percentage change of 2.8 percent would not be adjusted to
account for the forecast error correction. Table 2 shows the forecasted
and actual market basket amounts for FY 2018.
            Table 2--Difference Between the Forecasted and Actual Market Basket Increases for FY 2018
----------------------------------------------------------------------------------------------------------------
                                                                Forecasted FY    Actual FY 2018      FY 2018
                            Index                              2018 increase *    increase **       difference
----------------------------------------------------------------------------------------------------------------
SNF..........................................................             2.6              2.6              0.0
----------------------------------------------------------------------------------------------------------------
* Published in Federal Register; based on second quarter 2017 IGI forecast (2014-based index).
** Based on the second quarter 2019 IGI forecast, with historical data through the first quarter 2019 (2014-
  based index).
d. Multifactor Productivity Adjustment
    Section 1888(e)(5)(B)(ii) of the Act, as added by section 3401(b)
of the Patient Protection and Affordable Care Act (Affordable Care Act)
(Pub. L. 111-148, enacted March 23, 2010) requires that, in FY 2012 and
in subsequent FYs, the market basket percentage under the SNF payment
system (as described in section 1888(e)(5)(B)(i) of the Act) is to be
reduced annually by the multifactor productivity (MFP) adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act. Section
1886(b)(3)(B)(xi)(II) of the Act, in turn, defines the MFP adjustment
to be equal to the 10-year moving average of changes in annual economy-
wide private nonfarm business multi-factor productivity (as projected
by the Secretary for the 10-year period ending with the applicable FY,
year, cost-reporting period, or other annual period). The Bureau of
Labor Statistics
[[Page 38732]]
(BLS) is the agency that publishes the official measure of private
nonfarm business MFP. We refer readers to the BLS website at http://www.bls.gov/mfp for the BLS historical published MFP data.
    MFP is derived by subtracting the contribution of labor and capital
inputs growth from output growth. The projections of the components of
MFP are currently produced by IGI, a nationally recognized economic
forecasting firm with which CMS contracts to forecast the components of
the market baskets and MFP. To generate a forecast of MFP, IGI
replicates the MFP measure calculated by the BLS, using a series of
proxy variables derived from IGI's U.S. macroeconomic models. For a
discussion of the MFP projection methodology, we refer readers to the
FY 2012 SNF PPS final rule (76 FR 48527 through 48529) and the FY 2016
SNF PPS final rule (80 FR 46395). A complete description of the MFP
projection methodology is available on our website at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html.
(1) Incorporating the MFP Adjustment Into the Market Basket Update
    Per section 1888(e)(5)(A) of the Act, the Secretary shall establish
a SNF market basket index that reflects changes over time in the prices
of an appropriate mix of goods and services included in covered SNF
services. Section 1888(e)(5)(B)(ii) of the Act, added by section
3401(b) of the Affordable Care Act, requires that for FY 2012 and each
subsequent FY, after determining the market basket percentage described
in section 1888(e)(5)(B)(i) of the Act, the Secretary shall reduce such
percentage by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act (which we refer to as the MFP
adjustment). Section 1888(e)(5)(B)(ii) of the Act further states that
the reduction of the market basket percentage by the MFP adjustment may
result in the market basket percentage being less than zero for a FY,
and may result in payment rates under section 1888(e) of the Act being
less than such payment rates for the preceding fiscal year. Thus, if
the application of the MFP adjustment to the market basket percentage
calculated under section 1888(e)(5)(B)(i) of the Act results in an MFP-
adjusted market basket percentage that is less than zero, then the
annual update to the unadjusted federal per diem rates under section
1888(e)(4)(E)(ii) of the Act would be negative, and such rates would
decrease relative to the prior FY.
    In the FY 2020 proposed rule, the MFP adjustment, calculated as the
10-year moving average of changes in MFP for the period ending
September 30, 2020, was estimated to be 0.5 percent based on IGI's
first quarter 2019 forecast. However, in the FY 2020 proposed rule (84
FR 17624), we stated that if more recent data became available (for
example, a more recent estimate of the 2014-based SNF market basket or
MFP adjustment), we would use such data, if appropriate, to determine
the FY 2020 SNF market basket percentage change, labor-related share
relative importance, forecast error adjustment, and MFP adjustment in
the final rule. Since that time, we have updated the FY 2020 MFP
adjustment based on the IGI second quarter 2019 forecast. The revised
MFP adjustment based on updated data is 0.4 percent.
    Consistent with section 1888(e)(5)(B)(i) of the Act and Sec.
413.337(d)(2), the market basket percentage for FY 2020 for the SNF PPS
is based on IGI's second quarter 2019 forecast of the SNF market basket
percentage, which is estimated to be 2.8 percent. In accordance with
section 1888(e)(5)(B)(ii) of the Act and Sec.  413.337(d)(3), this
market basket percentage is then reduced by the MFP adjustment which,
as discussed above, is 0.4 percent. The resulting MFP-adjusted SNF
market basket update is equal to 2.4 percent, or 2.8 percent less 0.4
percentage point.
e. Market Basket Update Factor for FY 2020
    Sections 1888(e)(4)(E)(ii)(IV) and (e)(5)(i) of the Act require
that the update factor used to establish the FY 2020 unadjusted federal
rates be at a level equal to the market basket index percentage change.
Accordingly, we determined the total growth from the average market
basket level for the period of October 1, 2018, through September 30,
2019 to the average market basket level for the period of October 1,
2019, through September 30, 2020. This process yields a percentage
change in the 2014-based SNF market basket of 2.8 percent.
    As further explained in section III.B.2.c. of this final rule, as
applicable, we adjust the market basket percentage change by the
forecast error from the most recently available FY for which there is
final data and apply this adjustment whenever the difference between
the forecasted and actual percentage change in the market basket
exceeds a 0.5 percentage point threshold. Since the difference between
the forecasted FY 2018 SNF market basket percentage change and the
actual FY 2018 SNF market basket percentage change (FY 2018 is the most
recently available FY for which there is historical data) did not
exceed the 0.5 percentage point threshold, the FY 2020 market basket
percentage change of 2.8 percent is not adjusted by the forecast error
correction.
    Section 1888(e)(5)(B)(ii) of the Act requires us to reduce the
market basket percentage change by the MFP adjustment (10-year moving
average of changes in MFP for the period ending September 30, 2020)
which is 0.4 percent, as described in section III.B.2.d. of this final
rule. The resulting net SNF market basket update would equal 2.4
percent, or 2.8 percent less the 0.4 percentage point MFP adjustment.
    We also note that section 1888(e)(6)(A)(i) of the Act provides
that, beginning with FY 2018, SNFs that fail to submit data, as
applicable, in accordance with sections 1888(e)(6)(B)(i)(II) and (III)
of the Act for a fiscal year will receive a 2.0 percentage point
reduction to their market basket update for the fiscal year involved,
after application of section 1888(e)(5)(B)(ii) of the Act (the MFP
adjustment) and section 1888(e)(5)(B)(iii) of the Act (the 1 percent
market basket increase for FY 2018). In addition, section
1888(e)(6)(A)(ii) of the Act states that application of the 2.0
percentage point reduction (after application of section
1888(e)(5)(B)(ii) and (iii) of the Act) may result in the market basket
index percentage change being less than 0.0 for a fiscal year, and may
result in payment rates for a fiscal year being less than such payment
rates for the preceding fiscal year. Section 1888(e)(6)(A)(iii) of the
Act further specifies that the 2.0 percentage point reduction is
applied in a noncumulative manner, so that any reduction made under
section 1888(e)(6)(A)(i) of the Act applies only with respect to the
fiscal year involved, and that the reduction cannot be taken into
account in computing the payment amount for a subsequent fiscal year.
    As discussed above and in the proposed rule, we proposed to apply
the FY 2020 SNF market basket increase factor of 2.5 percent in our
determination of the FY 2020 SNF PPS unadjusted federal per diem rates,
which reflected a market basket increase factor of 3.0 percent, less a
0.5 percentage point MFP adjustment. However, as noted previously in
this final rule, based on updated data, we are revising the FY 2020 SNF
market basket update factor used in our determination
[[Page 38733]]
of the FY 2020 SNF PPS unadjusted federal per diem rates, to 2.4
percent, which reflects a revised market basket percentage increase of
2.8 percent, less the revised 0.4 percentage point MFP adjustment.
    We did not receive any comments regarding the calculation of the
SNF market basket percentage increase or the MFP adjustment.
Accordingly, for the reasons discussed in this final rule and in the FY
2020 SNF PPS proposed rule, we are finalizing the SNF market basket
update factor of 2.4 percent, which reflects the updated SNF market
basket percentage increase of 2.8 percent less the updated MFP
adjustment of 0.4 percentage point.
f. Unadjusted Federal per Diem Rates for FY 2020
    As discussed in the FY 2019 SNF PPS final rule (83 FR 39162), we
are implementing a new case-mix classification system to classify SNF
patients under the SNF PPS, beginning in FY 2020, called the Patient
Driven Payment Model (PDPM). As discussed in section V.B of that final
rule, under PDPM, the unadjusted federal per diem rates are divided
into six components, five of which are case-mix adjusted components
(Physical Therapy (PT), Occupational Therapy (OT), Speech-Language
Pathology (SLP), Nursing, and Non-Therapy Ancillaries (NTA)), and one
of which is a non-case-mix component, as exists under RUG-IV. In
calculating the FY 2020 unadjusted federal per diem rates that would be
used under PDPM in FY 2020, we applied the FY 2020 MFP-adjusted market
basket increase factor to the unadjusted federal per diem rates
provided in Tables 4 and 5 of the FY 2019 SNF PPS final rule (83 FR
39169) and then applied the methodology for separating the RUG-IV base
rates into the PDPM base rates, as discussed and finalized in section
V.B.3 of the FY 2019 SNF PPS final rule (83 FR 39191 through 39194).
    Tables 3 and 4 reflect the updated unadjusted federal rates for FY
2020, prior to adjustment for case-mix.
                            Table 3--FY 2020 Unadjusted Federal Rate per Diem--Urban
----------------------------------------------------------------------------------------------------------------
       Rate component              PT            OT            SLP         Nursing         NTA      Non-case-mix
----------------------------------------------------------------------------------------------------------------
Per Diem Amount.............       $60.75        $56.55        $22.68       $105.92        $79.91        $94.84
----------------------------------------------------------------------------------------------------------------
                            Table 4--FY 2020 Unadjusted Federal Rate per Diem--Rural
----------------------------------------------------------------------------------------------------------------
       Rate component              PT            OT            SLP         Nursing         NTA      Non-case-mix
----------------------------------------------------------------------------------------------------------------
Per Diem Amount.............       $69.25        $63.60        $28.57       $101.20        $76.34        $96.59
----------------------------------------------------------------------------------------------------------------
    Commenters submitted the following comments related to the proposed
rule's discussion of the Unadjusted Federal Per Diem rates for FY 2020.
A discussion of these comments, along with our responses, appears
below.
    Comment: We received a number of comments in relation to applying
the FY 2020 SNF market basket update factor in the determination of the
FY 2020 unadjusted federal per diem rates, with most commenters
supporting its application in determining the FY 2020 unadjusted per
diem rates, while a few commenters opposed its application. In their
March 2019 report (available at http://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch8_sec.pdf) and in their comment on the FY
2020 SNF PPS proposed rule, MedPAC recommended that we eliminate the
market basket update for SNFs altogether for FY 2020.
    Response: We appreciate all of the comments received on the
proposed market basket update for FY 2020. In response to those
comments opposing the application of the FY 2020 market basket update
factor in determining the FY 2020 unadjusted federal per diem rates,
specifically MedPAC's proposal to eliminate the market basket update
for SNFs, we are required to update the unadjusted federal per diem
rates for FY 2020 by the SNF market basket percentage change in
accordance with sections 1888(e)(4)(E)(ii)(IV) and (e)(5)(B) of the
Act.
    Comment: Several commenters raised concerns regarding the
calculation of the proposed unadjusted federal per diem rates. These
commenters believe that the unadjusted federal per diem rates were
calculated using an increase factor greater than the proposed 2.5
percent and requested clarification on exactly how the unadjusted
federal per diem rates for FY 2020 were calculated.
    Response: We appreciate the commenters highlighting this concern
regarding the calculation of the unadjusted federal per diem rates for
FY 2020, but we believe the commenters did not account for the effect
of an additional factor used in calculating the FY 2020 unadjusted
federal per diem rates.
    As discussed in the FY 2020 proposed rule (84 FR 17630), section
1888(e)(4)(G)(ii) of the Act requires that we apply the wage index
adjustment in a manner that does not result in aggregate payments under
the SNF PPS that are greater or less than would otherwise be made if
the wage adjustment had not been made. To accomplish this, as in prior
years, we multiply each of the components of the unadjusted federal
rates by a budget neutrality factor equal to the ratio of the weighted
average wage adjustment factor for FY 2019 to the weighted average wage
adjustment factor for FY 2020. In the FY 2020 proposed rule, this wage
adjustment budget neutrality factor was 1.0060. As noted below, due to
an update in the data used for this calculation, this adjustment factor
has been revised to be 1.0002.
    Comment: One commenter raised concerns with how the base rates used
under the SNF PPS, which have been adjusted by the SNF market basket
each year, are based on cost reports from 1995. The commenters
requested that CMS update the cost reporting base year used in deriving
the unadjusted federal rates.
    Response: We appreciate the commenter's suggestion regarding
updating the cost reporting base year used for deriving the unadjusted
federal per diem rates. However, section 1888(e)(4)(A) of the Act
requires that we use the ``allowable costs of extended care services
(excluding exception payments) for the facility for cost reporting
periods beginning in 1995.'' As such, we do not have the statutory
authority to update the cost reporting base year used to derive the SNF
PPS federal per diem rates.
[[Page 38734]]
    Comment: Two commenters requested that CMS consider a cost of
living adjustment, or COLA, for Hawaii and Alaska, stating that the
absence of a COLA differentiates SNFs from hospitals, which do receive
a COLA on non-labor costs. These commenters stated that providing care
in these states is more expensive than others due to their unique
circumstances.
    Response: While the law specifically authorizes a COLA for Hawaii
and Alaska for hospitals, it does not provide such an adjustment for
SNFs in these states. Specifically, section 1886(d)(5)(H) of the Act
authorizes the Secretary to make appropriate adjustments to reflect the
unique circumstances of hospitals located in Alaska and Hawaii.
    Accordingly, after considering the comments received, for the
reasons specified in this final rule and in the FY 2020 SNF PPS
proposed rule, we are finalizing the unadjusted federal per diem rates
set forth above, which were derived in accordance with the methodology
proposed in the FY 2020 SNF PPS proposed rule (84 FR 17624 through
17625) (as discussed above), using the revised SNF market basket update
of 2.4 percent and the revised wage index budget neutrality factor of
1.0002 (as discussed later in this preamble).
3. Case-Mix Adjustment
    Under section 1888(e)(4)(G)(i) of the Act, the federal rate also
incorporates an adjustment to account for facility case-mix, using a
classification system that accounts for the relative resource
utilization of different patient types. The statute specifies that the
adjustment is to reflect both a resident classification system that the
Secretary establishes to account for the relative resource use of
different patient types, as well as resident assessment data and other
data that the Secretary considers appropriate. In the FY 2019 final
rule (83 FR 39162, August 8, 2018), we finalized a new case-mix
classification model, the PDPM, to take effect beginning October 1,
2019. The RUG-IV model classifies most patients into a therapy payment
group and primarily uses the volume of therapy services provided to the
patient as the basis for payment classification, thus inadvertently
creating an incentive for SNFs to furnish therapy regardless of the
individual patient's unique characteristics, goals, or needs. PDPM
eliminates this incentive and improves the overall accuracy and
appropriateness of SNF payments by classifying patients into payment
groups based on specific, data-driven patient characteristics, while
simultaneously reducing the administrative burden on SNFs.
    The PDPM uses clinical data from the MDS to assign case-mix
classifiers to each patient that are then used to calculate a per diem
payment under the SNF PPS. As discussed in section III.C.1. of this
final rule, the clinical orientation of the case-mix classification
system supports the SNF PPS's use of an administrative presumption that
considers a beneficiary's initial case-mix classification to assist in
making certain SNF level of care determinations. Further, because the
MDS is used as a basis for payment, as well as a clinical assessment,
we have provided extensive training on proper coding and the timeframes
for MDS completion in our Resident Assessment Instrument (RAI) Manual.
As we have stated in prior rules, for an MDS to be considered valid for
use in determining payment, the MDS assessment should be completed in
compliance with the instructions in the RAI Manual in effect at the
time the assessment is completed. For payment and quality monitoring
purposes, the RAI Manual consists of both the Manual instructions and
the interpretive guidance and policy clarifications posted on the
appropriate MDS website at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html.
    Under section 1888(e)(4)(H) of the Act, each update of the payment
rates must include the case-mix classification methodology applicable
for the upcoming FY. The FY 2020 payment rates set forth in this final
rule reflect the use of the PDPM case-mix classification system from
October 1, 2019, through September 30, 2020. In the FY 2020 SNF PPS
proposed rule (84 FR 17627 through 17628), we listed the proposed case-
mix adjusted PDPM payment rates for FY 2020, provided separately for
urban and rural SNFs, in Tables A6 and A7 with corresponding case-mix
values.
    As discussed in the FY 2019 SNF PPS final rule (83 FR 39255 through
39256), we finalized the implementation of PDPM in a budget neutral
manner. To accomplish this, as discussed in the FY 2019 SNF PPS final
rule (83 FR 39256), the unadjusted PDPM case mix indexes (CMIs) were
multiplied by 1.46 so that the total estimated payments under the PDPM
would be equal to the total actual payments under RUG-IV. Further,
section 3.11.2 of the PDPM technical report, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/PDPM_Technical_Report_508.pdf, provided additional detail on the
calculation of the PDPM CMIs in order to achieve budget neutrality. In
that section, it states that ``to align the distribution of resources
across components with the statutory base rates, Acumen set CMIs such
that the average product of the CMI and the variable per diem
adjustment factor for a day of care is the same (set to 1) for each of
the five case-mix-adjusted components in PDPM. To do this, Acumen first
calculated the product of the CMI and the adjustment factor for every
utilization day for each component. Then, we calculated the average of
this product for each component. Finally, Acumen calculated the ratio
of 1 divided by the average product for each component. This ratio is
the standardization multiplier.'' As discussed in section 3.11.2 of the
PDPM Technical Report, the standardization multiplier is used to align
the distribution of resources across components with the statutory base
rates by setting the CMIs such that the average product of the
component CMI and the variable per diem adjustment factor for that
component for a day of care is the same. Effectively, the
standardization multiplier is used to mitigate the effect of the
variable per diem adjustment when calculating budget neutrality. The
CMIs were adjusted such that total payments under PDPM, if it had been
in effect in FY 2017, equal total actual payments made under RUG-IV in
FY 2017.
    In the proposed rule, we proposed to update the payment year used
as the basis for the calculation of the standardization multiplier and
budget neutrality multiplier, in order to best ensure that PDPM will be
implemented in a budget neutral manner, as finalized in the FY 2019 SNF
PPS Final Rule. We stated in the proposed rule that the only difference
in methodology between that used to calculate these multipliers and
CMIs in the FY 2019 SNF PPS final rule and that used to calculate the
multipliers and CMIs in the proposed rule is that, in the proposed
rule, we updated the data used from FY 2017 data to FY 2018 data. The
impact of using the updated FY 2018 data and the proposed updated
adjustment multipliers for standardization and budget neutrality, was
provided in Table 5 of the proposed rule (84 FR 17626). We note that
while the multipliers discussed in the FY 2019 SNF PPS final rule and
in the PDPM Technical Report are given to the hundredths place, in
order to make clear the effect of this change in data, the multipliers
in Table 5 are shown to the thousandths place. The standardization
[[Page 38735]]
and budget neutrality multipliers for this final rule are set forth in
Table 5.
                                             Table 5--PDPM Standardization and Budget Neutrality Multipliers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        FY 2017 data                                      FY 2018 data
                                                     ---------------------------------------------------------------------------------------------------
                      Component                           Standardization         Budget neutrality         Standardization         Budget neutrality
                                                             multiplier               multiplier               multiplier               multiplier
--------------------------------------------------------------------------------------------------------------------------------------------------------
PT..................................................                    1.031                    1.458                    1.028                    1.463
OT..................................................                    1.030                    1.458                    1.028                    1.463
SLP.................................................                    0.995                    1.458                    0.996                    1.463
Nursing.............................................                    0.995                    1.458                    0.996                    1.463
NTA.................................................                    0.817                    1.458                    0.811                    1.463
--------------------------------------------------------------------------------------------------------------------------------------------------------
    We did not receive any comments regarding our proposed calculation
of the PDPM standardization and budget neutrality multipliers.
Accordingly, for the reasons discussed in this final rule and in the FY
2020 SNF PPS proposed rule, we are finalizing the standardization and
budget neutrality multipliers, as proposed, without modification,
calculated based on FY 2018 data as set forth in Table 5. The CMIs
provided in Tables 6 and 7 of this final rule reflect the use of the
final multipliers in Table 5, which are based on FY 2018 data.
    We stated in the proposed rule that given the differences between
RUG-IV and PDPM in terms of patient classification and billing, it was
important that the format of Tables 6 and 7 reflect these differences.
More specifically, under both RUG-IV and PDPM, providers use a Health
Insurance Prospective Payment System (HIPPS) code on a claim in order
to bill for covered SNF services. Under RUG-IV, the HIPPS code includes
the three character RUG-IV group into which the patient classifies as
well as a two character assessment indicator code that represents the
assessment used to generate this code. Under PDPM, while providers
would still use a HIPPS code, the characters in that code represent
different things. For example, the first character represents the PT
and OT group into which the patient classifies. If the patient is
classified into the PT and OT group ``TA'', then the first character in
the patient's HIPPS code would be an A. Similarly, if the patient is
classified into the SLP group ``SB'', then the second character in the
patient's HIPPS code would be a B. The third character represents the
Nursing group into which the patient classifies. The fourth character
represents the NTA group into which the patient classifies. Finally,
the fifth character represents the assessment used to generate the
HIPPS code.
    Therefore, we stated in the proposed rule that we were modifying
the format of Tables A6 and A7 from what we have used for similar
tables in prior SNF PPS rulemaking, such as Tables A6 and A7 of the FY
2019 SNF PPS final rule (83 FR 39170 through 39172). We stated in the
proposed rule that Column 1 of modified Tables A6 and A7 represents the
character in the HIPPS code associated with a given PDPM component.
Columns 2 and 3 provide the case-mix index and associated case-mix
adjusted component rate, respectively, for the relevant PT group.
Columns 4 and 5 provide the case-mix index and associated case-mix
adjusted component rate, respectively, for the relevant OT group.
Columns 6 and 7 provide the case-mix index and associated case-mix
adjusted component rate, respectively, for the relevant SLP group.
Column 8 provides the nursing case-mix group (CMG) that is connected
with a given PDPM HIPPS character. For example, if the patient
qualified for the nursing group CBC1, then the third character in the
patient's HIPPS code would be a ``P.'' Columns 9 and 10 provide the
case-mix index and associated case-mix adjusted component rate,
respectively, for the relevant nursing group. Finally, columns 11 and
12 provide the case-mix index and associated case-mix adjusted
component rate, respectively, for the relevant NTA group. We received
no comments on the revised format of these tables.
    Tables A6 and A7 reflect the final PDPM case-mix adjusted rates and
case-mix indexes for FY 2020.Tables A6 and A7 do not reflect
adjustments which may be made to the SNF PPS rates as a result of
either the SNF QRP, discussed in section III.E.1. of this final rule,
or the SNF VBP program, discussed in section III.E.2. of this final
rule, or other adjustments, such as the variable per diem adjustment.
Further, we used the revised OMB delineations adopted in the FY 2015
SNF PPS final rule (79 FR 45632, 45634), with updates as reflected in
OMB Bulletin Nos. 15-01 and 17-01, to identify a facility's urban or
rural status for the purpose of determining which set of rate tables
would apply to the facility.
                                       Table 6--PDPM Case-Mix Adjusted Federal Rates and Associated Indexes--Urban
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Nursing    Nursing    Nursing
           PDPM group              PT CMI    PT rate     OT CMI    OT rate    SLP CMI    SLP rate     CMG        CMI        rate     NTA CMI    NTA rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
A..............................       1.53     $92.95       1.49     $84.26       0.68     $15.42        ES3       4.06    $430.04       3.24    $258.91
B..............................       1.70     103.28       1.63      92.18       1.82      41.28        ES2       3.07     325.17       2.53     202.17
C..............................       1.88     114.21       1.69      95.57       2.67      60.56        ES1       2.93     310.35       1.84     147.03
D..............................       1.92     116.64       1.53      86.52       1.46      33.11       HDE2       2.40     254.21       1.33     106.28
E..............................       1.42      86.27       1.41      79.74       2.34      53.07       HDE1       1.99     210.78       0.96      76.71
F..............................       1.61      97.81       1.60      90.48       2.98      67.59       HBC2       2.24     237.26       0.72      57.54
G..............................       1.67     101.45       1.64      92.74       2.04      46.27       HBC1       1.86     197.01  .........  .........
H..............................       1.16      70.47       1.15      65.03       2.86      64.86       LDE2       2.08     220.31  .........  .........
I..............................       1.13      68.65       1.18      66.73       3.53      80.06       LDE1       1.73     183.24  .........  .........
J..............................       1.42      86.27       1.45      82.00       2.99      67.81       LBC2       1.72     182.18  .........  .........
K..............................       1.52      92.34       1.54      87.09       3.70      83.92       LBC1       1.43     151.47  .........  .........
L..............................       1.09      66.22       1.11      62.77       4.21      95.48       CDE2       1.87     198.07  .........  .........
[[Page 38736]]

M..............................       1.27      77.15       1.30      73.52  .........  .........       CDE1       1.62     171.59  .........  .........
N..............................       1.48      89.91       1.50      84.83  .........  .........       CBC2       1.55     164.18  .........  .........
O..............................       1.55      94.16       1.55      87.65  .........  .........        CA2       1.09     115.45  .........  .........
P..............................       1.08      65.61       1.09      61.64  .........  .........       CBC1       1.34     141.93  .........  .........
Q..............................  .........  .........  .........  .........  .........  .........        CA1       0.94      99.56  .........  .........
R..............................  .........  .........  .........  .........  .........  .........       BAB2       1.04     110.16  .........  .........
S..............................  .........  .........  .........  .........  .........  .........       BAB1       0.99     104.86  .........  .........
T..............................  .........  .........  .........  .........  .........  .........       PDE2       1.57     166.29  .........  .........
U..............................  .........  .........  .........  .........  .........  .........       PDE1       1.47     155.70  .........  .........
V..............................  .........  .........  .........  .........  .........  .........       PBC2       1.22     129.22  .........  .........
W..............................  .........  .........  .........  .........  .........  .........        PA2       0.71      75.20  .........  .........
X..............................  .........  .........  .........  .........  .........  .........       PBC1       1.13     119.69  .........  .........
Y..............................  .........  .........  .........  .........  .........  .........        PA1       0.66      69.91  .........  .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Table 7--RUG-IV Case-Mix Adjusted Federal Rates and Associated Indexes--Rural
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Nursing    Nursing    Nursing
           PDPM group              PT CMI    PT rate     OT CMI    OT rate    SLP CMI    SLP rate     CMG        CMI        rate     NTA CMI    NTA rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
A..............................       1.53    $105.95       1.49     $94.76       0.68     $19.43        ES3       4.06    $410.87       3.24    $247.34
B..............................       1.70     117.73       1.63     103.67       1.82      52.00        ES2       3.07     310.68       2.53     193.14
C..............................       1.88     130.19       1.69     107.48       2.67      76.28        ES1       2.93     296.52       1.84     140.47
D..............................       1.92     132.96       1.53      97.31       1.46      41.71       HDE2       2.40     242.88       1.33     101.53
E..............................       1.42      98.34       1.41      89.68       2.34      66.85       HDE1       1.99     201.39       0.96      73.29
F..............................       1.61     111.49       1.60     101.76       2.98      85.14       HBC2       2.24     226.69       0.72      54.96
G..............................       1.67     115.65       1.64     104.30       2.04      58.28       HBC1       1.86     188.23  .........  .........
H..............................       1.16      80.33       1.15      73.14       2.86      81.71       LDE2       2.08     210.50  .........  .........
I..............................       1.13      78.25       1.18      75.05       3.53     100.85       LDE1       1.73     175.08  .........  .........
J..............................       1.42      98.34       1.45      92.22       2.99      85.42       LBC2       1.72     174.06  .........  .........
K..............................       1.52     105.26       1.54      97.94       3.70     105.71       LBC1       1.43     144.72  .........  .........
L..............................       1.09      75.48       1.11      70.60       4.21     120.28       CDE2       1.87     189.24  .........  .........
M..............................       1.27      87.95       1.30      82.68  .........  .........       CDE1       1.62     163.94  .........  .........
N..............................       1.48     102.49       1.50      95.40  .........  .........       CBC2       1.55     156.86  .........  .........
O..............................       1.55     107.34       1.55      98.58  .........  .........        CA2       1.09     110.31  .........  .........
P..............................       1.08      74.79       1.09      69.32  .........  .........       CBC1       1.34     135.61  .........  .........
Q..............................  .........  .........  .........  .........  .........  .........        CA1       0.94      95.13  .........  .........
R..............................  .........  .........  .........  .........  .........  .........       BAB2       1.04     105.25  .........  .........
S..............................  .........  .........  .........  .........  .........  .........       BAB1       0.99     100.19  .........  .........
T..............................  .........  .........  .........  .........  .........  .........       PDE2       1.57     158.88  .........  .........
U..............................  .........  .........  .........  .........  .........  .........       PDE1       1.47     148.76  .........  .........
V..............................  .........  .........  .........  .........  .........  .........       PBC2       1.22     123.46  .........  .........
W..............................  .........  .........  .........  .........  .........  .........        PA2       0.71      71.85  .........  .........
X..............................  .........  .........  .........  .........  .........  .........       PBC1       1.13     114.36  .........  .........
Y..............................  .........  .........  .........  .........  .........  .........        PA1       0.66      66.79  .........  .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. Wage Index Adjustment
    Section 1888(e)(4)(G)(ii) of the Act requires that we adjust the
federal rates to account for differences in area wage levels, using a
wage index that the Secretary determines appropriate. Since the
inception of the SNF PPS, we have used hospital inpatient wage data in
developing a wage index to be applied to SNFs. We proposed to continue
this practice for FY 2020, as we continue to believe that in the
absence of SNF-specific wage data, using the hospital inpatient wage
index data is appropriate and reasonable for the SNF PPS. As explained
in the update notice for FY 2005 (69 FR 45786), the SNF PPS does not
use the hospital area wage index's occupational mix adjustment, as this
adjustment serves specifically to define the occupational categories
more clearly in a hospital setting; moreover, the collection of the
occupational wage data also excludes any wage data related to SNFs.
Therefore, we believe that using the updated wage data exclusive of the
occupational mix adjustment continues to be appropriate for SNF
payments. As in previous years, we would continue to use the pre-
reclassified IPPS hospital wage data, unadjusted for occupational mix
and the rural floor, as the basis for the SNF PPS wage index. For FY
2020, the updated wage data are for hospital cost reporting periods
beginning on or after October 1, 2015 and before October 1, 2016 (FY
2016 cost report data).
    We note that section 315 of the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-
554, enacted December 21, 2000) authorized us to establish a geographic
reclassification procedure that is specific to SNFs, but only after
collecting the data necessary to establish a SNF PPS wage index that is
based on wage data from nursing homes. However, to date, this has
proven to be unfeasible due to the volatility of existing SNF wage data
and the significant amount of resources that would be required to
improve the quality of that data. More specifically, auditing all SNF
cost reports, similar to the process used to audit inpatient hospital
cost reports for purposes of the Inpatient Prospective Payment System
(IPPS) wage index, would place a burden on providers in terms of
recordkeeping and completion of the cost report worksheet. As discussed
in
[[Page 38737]]
greater detail later in this section, adopting such an approach would
require a significant commitment of resources by CMS and the Medicare
Administrative Contractors, potentially far in excess of those required
under the IPPS given that there are nearly five times as many SNFs as
there are inpatient hospitals. Therefore, while we continue to believe
that the development of such an audit process could improve SNF cost
reports in such a manner as to permit us to establish a SNF-specific
wage index, we do not believe this undertaking is feasible at this
time.
    In addition, we proposed to continue to use the same methodology
discussed in the SNF PPS final rule for FY 2008 (72 FR 43423) to
address those geographic areas in which there are no hospitals, and
thus, no hospital wage index data on which to base the calculation of
the FY 2020 SNF PPS wage index. For rural geographic areas that do not
have hospitals, and therefore, lack hospital wage data on which to base
an area wage adjustment, we stated we would use the average wage index
from all contiguous Core-Based Statistical Areas (CBSAs) as a
reasonable proxy. For FY 2020, there are no rural geographic areas that
do not have hospitals, and thus, this methodology would not be applied.
For rural Puerto Rico, we stated we would not apply this methodology
due to the distinct economic circumstances that exist there (for
example, due to the close proximity to one another of almost all of
Puerto Rico's various urban and non-urban areas, this methodology would
produce a wage index for rural Puerto Rico that is higher than that in
half of its urban areas); instead, we would continue to use the most
recent wage index previously available for that area. For urban areas
without specific hospital wage index data, we stated we would use the
average wage indexes of all of the urban areas within the state to
serve as a reasonable proxy for the wage index of that urban CBSA. For
FY 2020, the only urban area without wage index data available is CBSA
25980, Hinesville-Fort Stewart, GA.
    We note that after the publication of the FY 2020 SNF PPS proposed
rule, we were made aware of a minor calculation error in the file used
to compute the SNF wage index values. Specifically, the wage and hour
data for CBSA 31084 were inadvertently doubled. This caused an error in
the national average hourly wage, which factors into the calculation of
all wage index values. We have changed the programming logic to correct
this error. In addition, we corrected the classification of one
provider in North Carolina that was erroneously identified as being in
an urban CBSA. We also standardized our procedures for rounding, to
ensure consistency. The correction to the proposed rule wage index data
was not completed until after the comment period closed on June 18,
2019. This final rule reflects the corrected and updated wage index.
The final wage index applicable to FY 2020 is set forth in Tables A and
B available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
    In the SNF PPS final rule for FY 2006 (70 FR 45026, August 4,
2005), we adopted the changes discussed in OMB Bulletin No. 03-04 (June
6, 2003), which announced revised definitions for MSAs and the creation
of micropolitan statistical areas and combined statistical areas. In
adopting the CBSA geographic designations, we provided for a 1-year
transition in FY 2006 with a blended wage index for all providers. For
FY 2006, the wage index for each provider consisted of a blend of 50
percent of the FY 2006 MSA-based wage index and 50 percent of the FY
2006 CBSA-based wage index (both using FY 2002 hospital data). We
referred to the blended wage index as the FY 2006 SNF PPS transition
wage index. As discussed in the SNF PPS final rule for FY 2006 (70 FR
45041), since the expiration of this 1-year transition on September 30,
2006, we have used the full CBSA-based wage index values.
    In the FY 2015 SNF PPS final rule (79 FR 45644 through 45646), we
finalized changes to the SNF PPS wage index based on the newest OMB
delineations, as described in OMB Bulletin No. 13-01, beginning in FY
2015, including a 1-year transition with a blended wage index for FY
2015. OMB Bulletin No. 13-01 established revised delineations for
Metropolitan Statistical Areas, Micropolitan Statistical Areas, and
Combined Statistical Areas in the United States and Puerto Rico based
on the 2010 Census, and provided guidance on the use of the
delineations of these statistical areas using standards published in
the June 28, 2010 Federal Register (75 FR 37246 through 37252).
Subsequently, on July 15, 2015, OMB issued OMB Bulletin No. 15-01,
which provides minor updates to and supersedes OMB Bulletin No. 13-01
that was issued on February 28, 2013. The attachment to OMB Bulletin
No. 15-01 provides detailed information on the update to statistical
areas since February 28, 2013. The updates provided in OMB Bulletin No.
15-01 are based on the application of the 2010 Standards for
Delineating Metropolitan and Micropolitan Statistical Areas to Census
Bureau population estimates for July 1, 2012 and July 1, 2013. In
addition, on August 15, 2017, OMB issued Bulletin No. 17-01 which
announced a new urban CBSA, Twin Falls, Idaho (CBSA 46300). As we
previously stated in the FY 2008 SNF PPS proposed and final rules (72
FR 25538 through 25539, and 72 FR 43423), we wish to note that this and
all subsequent SNF PPS rules and notices are considered to incorporate
any updates and revisions set forth in the most recent OMB bulletin
that applies to the hospital wage data used to determine the current
SNF PPS wage index.
    We stated in the proposed rule that, once calculated, we would
apply the wage index adjustment to the labor-related portion of the
federal rate. Each year, we calculate a revised labor-related share,
based on the relative importance of labor-related cost categories (that
is, those cost categories that are labor-intensive and vary with the
local labor market) in the input price index. In the SNF PPS final rule
for FY 2018 (82 FR 36548 through 36566), we finalized a proposal to
revise the labor-related share to reflect the relative importance of
the 2014-based SNF market basket cost weights for the following cost
categories: Wages and Salaries; Employee Benefits; Professional Fees:
Labor-Related; Administrative and Facilities Support Services;
Installation, Maintenance, and Repair Services; All Other: Labor-
Related Services; and a proportion of Capital-Related expenses.
    We calculate the labor-related relative importance from the SNF
market basket, and it approximates the labor-related portion of the
total costs after taking into account historical and projected price
changes between the base year and FY 2020. The price proxies that move
the different cost categories in the market basket do not necessarily
change at the same rate, and the relative importance captures these
changes. Accordingly, the relative importance figure more closely
reflects the cost share weights for FY 2020 than the base year weights
from the SNF market basket.
    We calculate the labor-related relative importance for FY 2020 in
four steps. First, we compute the FY 2020 price index level for the
total market basket and each cost category of the market basket.
Second, we calculate a ratio for each cost category by dividing the FY
2020 price index level for that cost category by the total market
basket price index level. Third, we determine the FY
[[Page 38738]]
2020 relative importance for each cost category by multiplying this
ratio by the base year (2014) weight. Finally, we add the FY 2020
relative importance for each of the labor-related cost categories
(Wages and Salaries, Employee Benefits, Professional Fees: Labor-
Related, Administrative and Facilities Support Services, Installation,
Maintenance, and Repair Services, All Other: Labor-related services,
and a portion of Capital-Related expenses) to produce the FY 2020
labor-related relative importance.
    In the FY 2020 SNF PPS proposed rule, the labor-related share
calculation was based on IGI's first quarter 2019 forecast with
historical data through fourth quarter 2018. However, as discussed in
the FY 2020 SNF PPS proposed rule (84 FR 17624), our policy is if more
recent data become available (for example, a more recent estimate of
the 2014-based SNF market basket or MFP adjustment), we would use such
data, if appropriate, to determine the FY 2020 SNF market basket
percentage change, labor-related share relative importance, forecast
error adjustment, and MFP adjustment in the final rule. Since that
time, we revised the FY 2020 labor-related share calculation to reflect
the IGI second quarter 2019 forecast, with historical data through
first quarter 2019. Table 8 summarizes the final, revised labor-related
share for FY 2020, based on the updated data, compared to the labor-
related share that was used for the FY 2019 SNF PPS final rule.
     Table 8--Labor-Related Relative Importance, FY 2019 and FY 2020
------------------------------------------------------------------------
                                             Relative        Relative
                                            importance,     importance,
                                          labor-related,  labor-related,
                                           FY 2019 18:2     FY 2020 19:2
                                           forecast \1\    forecast \2\
------------------------------------------------------------------------
Wages and salaries......................            50.2            50.6
Employee benefits.......................            10.1            10.0
Professional Fees: Labor-Related........             3.7             3.7
Administrative and facilities support                0.5             0.5
 services...............................
Installation, Maintenance and Repair                 0.6             0.6
 Services...............................
All Other: Labor Related Services.......             2.5             2.6
Capital-related (.391)..................             2.9             2.9
                                         -------------------------------
    Total...............................            70.5            70.9
------------------------------------------------------------------------
\1\ Published in the Federal Register; based on second quarter 2018 IGI
  forecast.
\2\ Based on second quarter 2019 IGI forecast, with historical data
  through first quarter 2019.
    In the proposed rule (84 FR 17630), we stated that in order to
calculate the labor portion of the case-mix adjusted per diem rate, we
would multiply the total case-mix adjusted per diem rate, which is the
sum of all five case-mix adjusted components into which a patient
classifies, and the non-case-mix component rate, by the FY 2020 labor-
related share percentage provided in Table 8. The remaining portion of
the rate would be the non-labor portion. In prior years, we have
included tables which provide the case-mix adjusted RUG-IV rates, by
RUG-IV group, broken out by total rate, labor portion and non-labor
portion, such as Table 9 of the FY 2019 SNF PPS final rule (83 FR
39175). However, as we discussed in the proposed rule (84 FR 17630),
under PDPM, as the total rate is calculated as a combination of six
different component rates, five of which are case-mix adjusted, and
given the sheer volume of possible combinations of these five case-mix
adjusted components, it is not feasible to provide tables similar to
those that have existed in prior rulemaking.
    Therefore, to aid stakeholders in understanding the effect of the
wage index on the calculation of the SNF per diem rate, we have
included a revised hypothetical rate calculation in Table 9.
    Section 1888(e)(4)(G)(ii) of the Act also requires that we apply
this wage index in a manner that does not result in aggregate payments
under the SNF PPS that are greater or less than would otherwise be made
if the wage adjustment had not been made. For FY 2020 (federal rates
effective October 1, 2019), we would apply an adjustment to fulfill the
budget neutrality requirement. We would meet this requirement by
multiplying each of the components of the unadjusted federal rates by a
budget neutrality factor equal to the ratio of the weighted average
wage adjustment factor for FY 2019 to the weighted average wage
adjustment factor for FY 2020. For this calculation, we would use the
same FY 2018 claims utilization data for both the numerator and
denominator of this ratio. We define the wage adjustment factor used in
this calculation as the labor share of the rate component multiplied by
the wage index plus the non-labor share of the rate component.
    We note that in the FY 2020 SNF PPS proposed rule, the budget
neutrality factor calculation was based on the wage and cost data
available at the time of the proposed rule. As a result of correcting
the wage index error discussed above, the budget neutrality factor that
was calculated for the proposed rule has been revised. The proposed FY
2020 budget neutrality factor was 1.0060. The revised and final FY 2020
budget neutrality factor, which was used in calculating the final
unadjusted FY 2020 federal per diem rates, is 1.0002.
    Commenters submitted the following comments related to our proposed
calculation of the SNF wage index. A discussion of these comments,
along with our responses, appears below.
    Comment: Several commenters raised concerns with the use of the
inpatient hospital wage index in lieu of a SNF-specific wage index.
These commenters provided suggested revisions to the manner in which
CMS uses the inpatient hospital wage index under the SNF PPS. One
commenter suggested that CMS apply the average state wage index in
areas where all of the hospitals within that CBSA have been
reclassified under the hospital wage index to a different CBSA, similar
to how the average wage index is used in areas where no hospitals exist
within a CBSA. A few commenters suggested that CMS consider modifying
the current hospital wage data that are used to construct the SNF PPS
wage index, in order to reflect more closely the SNF environment, by
trimming hospital wage data to reflect positions staffed in nursing
homes, as well as using an occupational mix adjustment specific to SNFs
and/or rural
[[Page 38739]]
floor under the SNF PPS. A few commenters also requested that CMS
develop a SNF-specific wage index, which would allow for the
possibility of a reclassification methodology under the SNF PPS.
    Response: We appreciate all of the suggestions and comments on the
SNF PPS wage index. With regard to the suggestion that CMS develop a
SNF-specific wage index, which would allow for the possibility of a
reclassification methodology under the SNF PPS, as we discussed in the
FY 2020 SNF PPS proposed rule (84 FR 17628) and in prior rules (most
recently in the FY 2019 SNF PPS final rule (83 FR 39177 through
39178)), section 315 of BIPA authorized us to establish a geographic
reclassification procedure that is specific to SNFs, but only after
collecting the data necessary to establish a SNF PPS wage index that is
based on wage data from nursing homes. However, to date, the
development of a SNF-specific wage index has proven to be unfeasible
due to the volatility of existing SNF wage data and the significant
amount of resources that would be required to improve the quality of
that data. More specifically, auditing all SNF cost reports, similar to
the process used to audit inpatient hospital cost reports for purposes
of the Inpatient Prospective Payment System (IPPS) wage index, would
place a burden on providers in terms of recordkeeping and completion of
the cost report worksheet. In addition, adopting such an approach would
require a significant commitment of resources by CMS and the Medicare
Administrative Contractors, potentially far in excess of those required
under the IPPS given that there are nearly five times as many SNFs as
there are inpatient hospitals. Therefore, while we continue to believe
that the development of such an audit process could improve SNF cost
reports in such a manner as to permit us to establish a SNF-specific
wage index, we do not believe this undertaking is feasible at this
time. While we continue to review all available data and contemplate
potential methodological approaches for a SNF-specific wage index in
the future, we continue to believe that in the absence of the
appropriate SNF-specific wage data, using the pre-reclassified, pre-
rural floor hospital inpatient wage data (without the occupational mix
adjustment) is appropriate and reasonable for the SNF PPS.
    With regard to those comments on modifying the current hospital
wage data that are used to construct the SNF PPS wage index, in order
to reflect more closely the SNF environment, by trimming hospital wage
data to reflect positions staffed in nursing homes, applying an
occupational mix adjustment, and other such suggestions, we believe it
would be appropriate to consider such changes in future rulemaking.
However, while we consider whether or not such approaches would improve
the SNF PPS wage index, we would note that other provider types also
use the hospital wage index as the basis for their associated wage
index. As such, we believe that such a recommendation should be part of
a broader discussion on wage index reform across Medicare payment
systems.
    With regard to using an occupational mix adjustment for the SNF PPS
wage index, as discussed above and in the FY 2020 SNF PPS proposed rule
(84 FR 17628), the SNF PPS does not use the hospital area wage index's
occupational mix adjustment, as this adjustment serves specifically to
define the occupational categories more clearly in a hospital setting;
moreover, the collection of the hospital occupational wage data
excludes any wage data related to SNFs. Therefore, we believe that
using the updated hospital wage data exclusive of the IPPS occupational
mix adjustment continues to be appropriate for SNF payments. With
regard to developing a SNF-specific occupational mix adjustment, we
appreciate this suggestion and may consider this in future rulemaking.
    With regard to implementing a rural floor under the SNF PPS, we do
not believe it would be prudent at this time to adopt such a policy,
particularly because MedPAC has recommended eliminating the rural floor
policy from the calculation of the IPPS wage index (see, for example,
Chapter 3 of MedPAC's March 2013 Report to Congress on Medicare Payment
Policy, available at http://www.medpac.gov/docs/default-source/reports/mar13_ch03.pdf, which notes on page 65 that, in 2007, MedPAC had
recommended eliminating these special wage index adjustments and
adopting a new wage index system to avoid geographic inequities that
can occur due to current wage index policies (Medicare Payment Advisory
Commission 2007b)). If we adopted the rural floor policy at this time,
the SNF PPS wage index could become vulnerable to problems similar to
those MedPAC identified in its March 2013 Report to Congress.
    Finally, with regard to the suggestion that CMS use the average
state wage index for areas where all of the hospitals within a CBSA
have reclassified under the IPPS out of the CBSA to a different CBSA,
we believe that such circumstances are different from those in which
there are no hospitals located within the CBSA, specifically CBSA
25980, Hinesville-Fort Stewart, GA, where we use the average wage index
for all urban areas in the state. In the circumstance where all
hospitals in a CBSA have reclassified under the IPPS to a different
CBSA, there still are hospitals geographically located in the CBSA and
we would have hospital data for the associated CBSA, even if the
hospitals subsequently reclassify out of the CBSA. Therefore, we would
have data upon which to base our calculation of the SNF PPS wage index
for that CBSA, and we think it would be appropriate to use that data to
determine the SNF PPS wage index as we do in other CBSAs.
    After consideration of the comments received, for the reasons
discussed in this final rule and in the FY 2020 SNF PPS proposed rule,
we are finalizing, without modification, our proposed policies
discussed above relating to the wage index and the labor-related share.
The final wage index applicable to FY 2020 is set forth in Tables A and
B available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
5. Wage Index Comment Solicitation
    As discussed above, historically, we have calculated the SNF PPS
wage index values using unadjusted wage index values from another
provider setting. Stakeholders have frequently commented on certain
aspects of the SNF PPS wage index values and their impact on payments.
In the FY 2020 SNF PPS proposed rule, we solicited comments on concerns
stakeholders may have regarding the wage index used to adjust SNF PPS
payments and suggestions for possible updates and improvements to the
geographic adjustment of SNF PPS payments.
    Commenters submitted the following comments related to the wage
index comment solicitation. A discussion of these comments, along with
our responses, appears below.
    Comment: Several commenters raised concerns with the wage index
related proposals contained in the FY 2020 Inpatient Prospective
Payment System proposed rule, specifically the proposal related to
those hospitals whose wage indexes are in the bottom 25 percent of all
wage index values. Several commenters also raised issues with the
manner in which the hospital wage index was calculated. These
commenters also highlighted discrepancies between the SNF PPS wage
index values posted on the CMS
[[Page 38740]]
website and those calculated using public use files made available by
CMS. A few commenters stated concerns with the improper exclusion of
seven hospitals in California. One commenter stated that Part B wages
should be removed from the calculation of the hospital wage index.
    Response: We appreciate these comments on the inpatient hospital
wage index and associated proposed changes and will pass these comments
to our colleagues responsible for the hospital wage index. With respect
to the highlighted discrepancies between the posted proposed SNF PPS
wage index values and those calculated using the public use file, as
stated above, there was a minor error in the file used to compute the
proposed SNF wage index values. We have corrected this error in
computing the SNF wage index values and payment rates for this final
rule.
    Comment: One commenter stated that CMS has the statutory authority
to implement geographically-specific updates associated with rising
state and/or regional minimum wage standards. The commenter requested
that such updates be made at the Core-Based Statistical Area (CBSA)
levels.
    Response: With regard to rising minimum wage standards, we would
note that such increases will likely be reflected in future data used
to create the SNF wage index, as these changes to state minimum wage
standards would be reflected in increased wages to SNF staff.
Therefore, we already incorporate such standards into the calculation
of the SNF PPS wage index to the extent that these standards have an
impact on facility wages.
6. SNF Value-Based Purchasing Program
    Beginning with payment for services furnished on October 1, 2018,
section 1888(h) of the Act requires the Secretary to reduce the
adjusted Federal per diem rate determined under section 1888(e)(4)(G)
of the Act otherwise applicable to a SNF for services furnished during
a fiscal year by 2 percent, and to adjust the resulting rate for a SNF
by the value-based incentive payment amount earned by the SNF based on
the SNF's performance score for that fiscal year under the SNF VBP
Program. To implement these requirements, we finalized in the FY 2019
SNF PPS final rule the addition of Sec.  413.337(f) to our regulations
(83 FR 39178).
    Please see section III.E.2. of this final rule for a further
discussion of our policies for the SNF VBP Program.
7. Adjusted Rate Computation Example
    The following tables provide examples generally illustrating
payment calculations during FY 2020 under PDPM for a hypothetical 30-
day SNF stay, involving the hypothetical SNF XYZ, located in Frederick,
MD (Urban CBSA 43524), for a hypothetical patient who is classified
into such groups that the patient's HIPPS code is NHNC1. Table 9 shows
the adjustments made to the federal per diem rates (prior to
application of any adjustments under the SNF QRP and SNF VBP programs
as discussed above) to compute the provider's case-mix adjusted per
diem rate for FY 2020, based on the patient's PDPM classification, as
well as how the VPD adjustment factor affects calculation of the per
diem rate for a given day of the stay. Table 10 shows the adjustments
made to the case-mix adjusted per diem rate from Table 9 to account for
the provider's wage index. The wage index used in this example is based
on the FY 2020 SNF PPS wage index that appears in Table A available on
the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html. Finally, Table 11 provides the
case-mix and wage index adjusted per-diem rate for this patient for
each day of the 30-day stay, as well as the total payment for this
stay. Table 11 also includes the variable per diem (VPD) adjustment
factors for each day of the patient's stay, to clarify why the
patient's per diem rate changes for certain days of the stay. As
illustrated in Table 11, SNF XYZ's total PPS payment for this
particular patient's stay would equal $19,975.62.
                            Table 9--PDPM Case-Mix Adjusted Rate Computation Example
                                           [Per diem rate calculation]
----------------------------------------------------------------------------------------------------------------
                                                                                        VPD             VPD
               Component                     Component group         Component      adjustment      adjustment
                                                                       rate           factor           rate
----------------------------------------------------------------------------------------------------------------
PT....................................  TN......................          $89.91            1.00          $89.91
OT....................................  TN......................           84.83            1.00           84.83
SLP...................................  SH......................           64.86  ..............           64.86
Nursing...............................  CBC2....................          164.18  ..............          164.18
NTA...................................  NC......................          147.03            3.00          441.09
Non-Case-Mix..........................  ........................           94.84  ..............           94.84
                                                                 -----------------------------------------------
    Total PDPM Case-Mix Adj. Per Diem.  ........................  ..............  ..............          939.71
----------------------------------------------------------------------------------------------------------------
                                                 Table 10--Wage Index Adjusted Rate Computation Example
                                                        [PDPM wage index adjustment calculation]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Total case mix
                                                     PDPM case-mix                                        Wage index       Non-labor      and wage index
                    HIPPS code                        adjusted per    Labor portion      Wage index     adjusted rate       portion         adjustment
                                                          diem                                                                                 rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
NHNC1.............................................         $939.71          $666.25           0.9839          $655.53          $273.46          $928.98
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 38741]]
                                   Table 11--Adjusted Rate Computation Example
----------------------------------------------------------------------------------------------------------------
                                                                                                   Case mix and
                                                                      NTA VPD        PT/OT VPD      wage index
                           Day of stay                              adjustment      adjustment     adjusted  per
                                                                      factor          factor         diem rate
----------------------------------------------------------------------------------------------------------------
1...............................................................             3.0             1.0         $928.98
2...............................................................             3.0             1.0          928.98
3...............................................................             3.0             1.0          928.98
4...............................................................             1.0             1.0          638.28
5...............................................................             1.0             1.0          638.28
6...............................................................             1.0             1.0          638.28
7...............................................................             1.0             1.0          638.28
8...............................................................             1.0             1.0          638.28
9...............................................................             1.0             1.0          638.28
10..............................................................             1.0             1.0          638.28
11..............................................................             1.0             1.0          638.28
12..............................................................             1.0             1.0          638.28
13..............................................................             1.0             1.0          638.28
14..............................................................             1.0             1.0          638.28
15..............................................................             1.0             1.0          638.28
16..............................................................             1.0             1.0          638.28
17..............................................................             1.0             1.0          638.28
18..............................................................             1.0             1.0          638.28
19..............................................................             1.0             1.0          638.28
20..............................................................             1.0             1.0          638.28
21..............................................................             1.0            0.98          634.83
22..............................................................             1.0            0.98          634.83
23..............................................................             1.0            0.98          634.83
24..............................................................             1.0            0.98          634.83
25..............................................................             1.0            0.98          634.83
26..............................................................             1.0            0.98          634.83
27..............................................................             1.0            0.98          634.83
28..............................................................             1.0            0.96          631.37
29..............................................................             1.0            0.96          631.37
30..............................................................             1.0            0.96          631.37
                                                                 -----------------------------------------------
    Total Payment...............................................  ..............  ..............       19,975.62
----------------------------------------------------------------------------------------------------------------
C. Additional Aspects of the SNF PPS
1. SNF Level of Care--Administrative Presumption
    The establishment of the SNF PPS did not change Medicare's
fundamental requirements for SNF coverage. However, because the case-
mix classification is based, in part, on the beneficiary's need for
skilled nursing care and therapy, we have attempted, where possible, to
coordinate claims review procedures with the existing resident
assessment process and case-mix classification system discussed in
section III.B.3. of this final rule. This approach includes an
administrative presumption that utilizes a beneficiary's correct
assignment, at the outset of the SNF stay, of one of the case-mix
classifiers designated for this purpose to assist in making certain SNF
level of care determinations.
    In accordance with the regulations at Sec.  413.345, we include in
each update of the federal payment rates in the Federal Register a
discussion of the resident classification system that provides the
basis for case-mix adjustment. We also designate those specific
classifiers under the case-mix classification system that represent the
required SNF level of care, as provided in Sec.  409.30. This
designation reflects an administrative presumption that those
beneficiaries who are correctly assigned one of the designated case-mix
classifiers on the initial Medicare assessment are automatically
classified as meeting the SNF level of care definition up to and
including the assessment reference date (ARD) for that assessment.
    A beneficiary who does not qualify for the presumption is not
automatically classified as either meeting or not meeting the level of
care definition, but instead receives an individual determination on
this point using the existing administrative criteria. This presumption
recognizes the strong likelihood that those beneficiaries who are
assigned one of the designated case-mix classifiers during the
immediate post-hospital period would require a covered level of care,
which would be less likely for other beneficiaries.
    In the July 30, 1999 final rule (64 FR 41670), we indicated that we
would announce any changes to the guidelines for Medicare level of care
determinations related to modifications in the case-mix classification
structure. The FY 2018 final rule (82 FR 36544) further specified that
we would henceforth disseminate the standard description of the
administrative presumption's designated groups via the SNF PPS website
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/index.html (where such designations appear in the paragraph
entitled ``Case Mix Adjustment''), and would publish such designations
in rulemaking only to the extent that we actually intend to make
changes in them. Under that approach, the set of case-mix classifiers
designated for this purpose under PDPM was finalized in the FY 2019 SNF
PPS final rule (83 FR 39253) and is posted on the SNF PPS website
(https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/index.html), in the paragraph entitled ``Case Mix Adjustment.''
    However, we note that this administrative presumption policy does
not supersede the SNF's responsibility to ensure that its decisions
relating to level of care are appropriate and timely, including a
review to confirm that any services prompting the assignment of one of
the designated case-mix
[[Page 38742]]
classifiers (which, in turn, serves to trigger the administrative
presumption) are themselves medically necessary. As we explained in the
FY 2000 SNF PPS final rule (64 FR 41667), the administrative
presumption is itself rebuttable in those individual cases in which the
services actually received by the resident do not meet the basic
statutory criterion of being reasonable and necessary to diagnose or
treat a beneficiary's condition (according to section 1862(a)(1) of the
Act). Accordingly, the presumption would not apply, for example, in
those situations where the sole classifier that triggers the
presumption is itself assigned through the receipt of services that are
subsequently determined to be not reasonable and necessary. Moreover,
we want to stress the importance of careful monitoring for changes in
each patient's condition to determine the continuing need for Part A
SNF benefits after the ARD of the initial Medicare assessment (as
discussed further in section III.D.3 of this final rule). Finally,
regarding the new set of case-mix classifiers designated under the PDPM
for this purpose, we noted in the FY 2019 SNF PPS final rule (83 FR
39252, August 8, 2018) our intent ``. . . to review the new
designations going forward and make further adjustments over time as we
gain actual operating experience under the new classification model.''
Accordingly, to the extent that it may become evident in actual
practice that these new criteria are not accurately performing their
intended role (for example, by capturing cases that do not actually
require an SNF level of care), we would propose appropriate adjustments
to correct them.
    Commenters submitted the following comments related to the proposed
rule's discussion of the administrative level of care presumption. A
discussion of these comments, along with our responses, appears below.
    Comment: Commenters expressed support for CMS' intent to ``review
the new designations going forward and make further adjustments over
time as we gain actual operating experience under the new
classification model'' (84 FR 17632). One commenter specifically
endorsed CMS' longstanding position that under PDPM, SNFs are still
required to make decisions related to level of care appropriately and
in a timely manner and to monitor for changes in patients' conditions
related to the continuing need for Part A SNF benefits after the
assessment reference date of the initial assessment.
    Response: We appreciate the support for our position, and note that
our ongoing review of the administrative presumption will include
careful monitoring of the newly-designated classifiers under the PDPM
to ensure that they are not inappropriately capturing significant
numbers of nonskilled cases in actual practice. In that context, we
have repeatedly noted--most recently, in the FY 2019 SNF PPS final rule
(83 FR 39251)--that the actual purpose of the level of care presumption
has always been to afford a streamlined and simplified administrative
procedure for readily identifying those beneficiaries with the greatest
likelihood of meeting the level of care criteria that in no way serves
to disadvantage other beneficiaries who may also meet the level of care
criteria. Accordingly, in view of the presumption's intended role of
identifying only the most clearly qualified cases, once a particular
classifier has been found in actual practice to capture a significant
number of nonskilled cases, we believe that it would be inappropriate
to continue to designate such a classifier for use in triggering the
coverage that the presumption provides.
2. Consolidated Billing
    Sections 1842(b)(6)(E) and 1862(a)(18) of the Act (as added by
section 4432(b) of the BBA 1997) require a SNF to submit consolidated
Medicare bills to its Medicare Administrative Contractor (MAC) for
almost all of the services that its residents receive during the course
of a covered Part A stay. In addition, section 1862(a)(18) of the Act
places the responsibility with the SNF for billing Medicare for
physical therapy, occupational therapy, and speech-language pathology
services that the resident receives during a noncovered stay. Section
1888(e)(2)(A) of the Act excludes a small list of services from the
consolidated billing provision (primarily those services furnished by
physicians and certain other types of practitioners), which remain
separately billable under Part B when furnished to a SNF's Part A
resident. These excluded service categories are discussed in greater
detail in section V.B.2. of the May 12, 1998 interim final rule (63 FR
26295 through 26297).
    A detailed discussion of the legislative history of the
consolidated billing provision is available on the SNF PPS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Legislative_History_2018-10-01.pdf. In particular, section
103 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act
of 1999 (BBRA, Pub. L. 106-113, enacted November 29, 1999) amended
section 1888(e)(2)(A) of the Act by further excluding a number of
individual high-cost, low probability services, identified by
Healthcare Common Procedure Coding System (HCPCS) codes, within several
broader categories (chemotherapy items, chemotherapy administration
services, radioisotope services, and customized prosthetic devices)
that otherwise remained subject to the provision. We discuss this BBRA
amendment in greater detail in the SNF PPS proposed and final rules for
FY 2001 (65 FR 19231 through 19232, April 10, 2000, and 65 FR 46790
through 46795, July 31, 2000), as well as in Program Memorandum AB-00-
18 (Change Request #1070), issued March 2000, which is available online
at www.cms.gov/transmittals/downloads/ab001860.pdf.
    As explained in the FY 2001 proposed rule (65 FR 19232), the
amendments enacted in section 103 of the BBRA not only identified for
exclusion from this provision a number of particular service codes
within four specified categories (that is, chemotherapy items,
chemotherapy administration services, radioisotope services, and
customized prosthetic devices), but also gave the Secretary the
authority to designate additional, individual services for exclusion
within each of the specified service categories. In the proposed rule
for FY 2001, we also noted that the BBRA Conference report (H.R. Rep.
No. 106-479 at 854 (1999) (Conf. Rep.)) characterizes the individual
services that this legislation targets for exclusion as high-cost, low
probability events that could have devastating financial impacts
because their costs far exceed the payment SNFs receive under the PPS.
According to the conferees, section 103(a) of the BBRA is an attempt to
exclude from the PPS certain services and costly items that are
provided infrequently in SNFs. By contrast, the amendments enacted in
section 103 of the BBRA do not designate for exclusion any of the
remaining services within those four categories (thus, leaving all of
those services subject to SNF consolidated billing), because they are
relatively inexpensive and are furnished routinely in SNFs.
    As we further explained in the final rule for FY 2001 (65 FR
46790), and as is consistent with our longstanding policy, any
additional service codes that we might designate for exclusion under
our discretionary authority must meet the same statutory criteria used
in identifying the original codes excluded from consolidated billing
under section 103(a) of the BBRA: They must fall within one of the four
service categories specified in the BBRA; and they also must meet the
same standards of high
[[Page 38743]]
cost and low probability in the SNF setting, as discussed in the BBRA
Conference report. Accordingly, we characterized this statutory
authority to identify additional service codes for exclusion as
essentially affording the flexibility to revise the list of excluded
codes in response to changes of major significance that may occur over
time (for example, the development of new medical technologies or other
advances in the state of medical practice) (65 FR 46791). In the
proposed rule, we specifically invited public comments identifying
HCPCS codes in any of these four service categories (chemotherapy
items, chemotherapy administration services, radioisotope services, and
customized prosthetic devices) representing recent medical advances
that might meet our criteria for exclusion from SNF consolidated
billing. We stated in the proposed rule that we may consider excluding
a particular service if it meets our criteria for exclusion as
specified above. We requested that commenters identify in their
comments the specific HCPCS code that is associated with the service in
question, as well as their rationale for requesting that the identified
HCPCS code(s) be excluded.
    We note that the original BBRA amendment (as well as the
implementing regulations) identified a set of excluded services by
means of specifying HCPCS codes that were in effect as of a particular
date (in that case, as of July 1, 1999). Identifying the excluded
services in this manner made it possible for us to utilize program
issuances as the vehicle for accomplishing routine updates of the
excluded codes, to reflect any minor revisions that might subsequently
occur in the coding system itself (for example, the assignment of a
different code number to the same service). Accordingly, we stated in
the proposed rule that, in the event that we identify through the
current rulemaking cycle any new services that would actually represent
a substantive change in the scope of the exclusions from SNF
consolidated billing, we would identify these additional excluded
services by means of the HCPCS codes that are in effect as of a
specific date (in this case, as of October 1, 2019). By making any new
exclusions in this manner, we could similarly accomplish routine future
updates of these additional codes through the issuance of program
instructions.
    Commenters submitted the following comments related to the proposed
rule's discussion of consolidated billing. A discussion of these
comments, along with our responses, appears below.
    Comment: One commenter expressed support for the overall concept of
consolidated billing, but cautioned that problems in its practical
application can create difficulties for suppliers in obtaining payment
for those services that are subject to this provision. The commenter
noted that when a MAC denies separate payment to a supplier for a
bundled SNF service, the denial notice may not specify the particular
SNF involved; even after the supplier has identified the SNF in
question, the latter may be reluctant to pay the supplier, especially
if the SNF itself did not directly order the service. The commenter
suggested that the consolidated billing edits should deny separate
payment to the supplier only for those services that are directly
ordered by the practitioner who is responsible for the patient in the
SNF.
    Response: Sections 1862(a)(18) and 1866(a)(1)(H)(ii) of the Act
specifically require the SNF itself to be responsible for furnishing
the entire range of covered SNF services (the bundled services)--either
directly with its own resources, or under an ``arrangement'' with an
outside supplier in which the supplier's payment would come from the
SNF (rather than from Part B or the beneficiary). Further, as noted in
Section 70.4 of the Medicare Benefit Policy Manual, Chapter 8
(available online at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c08.pdf), while
. . . the specific details of the ensuing payment arrangement
between the SNF and the outside supplier (such as the actual payment
amount and timeframe) represent a private, ``marketplace''
transaction that is negotiated between the parties themselves . . .
in order for the arrangement itself to be valid, the SNF must, in
fact, make payment to its supplier for services rendered.
    In that context, the Medicare Claims Processing Manual, Chapter 6
(available online at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c06.pdf) discusses in Sections 10.4ff.
the importance of establishing written agreements between SNFs and
their suppliers--preferably before services are actually rendered--to
ensure that both parties have arrived at a common understanding of the
specific terms of payment and also to help resolve any disputes that
may arise regarding them, and it describes some additional steps that
both SNFs and suppliers can take to prevent problems from developing.
For example, with reference to suppliers, Section 10.4.2 specifies that
. . . prior to furnishing services to a Medicare beneficiary, the
supplier should routinely ascertain whether the beneficiary is
currently receiving any comprehensive Medicare benefits (such as SNF
or home health benefits) for which Medicare makes a bundled payment
that could potentially include the supplier's services. If the
supplier ascertains that a particular beneficiary is, in fact, a
resident of an SNF with which the supplier does not have a valid
arrangement in place, then the supplier should contact the SNF
before actually furnishing any services to that beneficiary that are
subject to the consolidated billing provision.
    Notwithstanding such precautions, if a supplier nevertheless
continues to encounter difficulties either in identifying the
particular SNF involved or in securing that SNF's compliance with the
consolidated billing requirement, the supplier's appropriate contact at
that point would be with its servicing MAC, which is responsible for
providing technical assistance and support to the entities that it
serves. In addition, the Medicare fee-for-service operations component
of the servicing CMS Regional Office is available to assist as needed
in helping to resolve such situations.
    Comment: Commenters urged CMS to create an exclusion from
consolidated billing for clotting factor and non-factor medication
therapies for patients with hemophilia, similar to the existing
exclusions for chemotherapy and its administration, radioisotope
services, and certain customized prosthetic devices.
    Response: We note that the item/service categories cited by the
commenters (chemotherapy and its administration, radioisotope services,
and certain customized prosthetic devices) are in statute at section
1888(e)(2)(A)(iii) of the Act (as enacted through section 103 of the
BBRA). As we indicated previously in the FY 2012 SNF PPS final rule (76
FR 48531), hemophilia treatments are outside the particular service
categories that the statute authorizes for exclusion, and establishing
an exclusion category for hemophilia treatment services, or any other
service categories that are not specified in the statute, would require
legislation by Congress to amend this statutory provision. Thus, we
decline to adopt the commenter's suggestion.
    Comment: In terms of considering new chemotherapy drugs for
exclusion, one commenter suggested that CMS should focus specifically
on their cost, noting that such drugs do not always have their own
HCPCS code. Another commenter expressed support for expanding the list
of chemotherapy exclusions from consolidated billing as helping to
``ensure that life-saving treatment is not interoperated during a
[[Page 38744]]
patient's transition to sub-acute rehab,'' but suggested that ``rather
than focusing on specific HCPCS for the expansion list,'' CMS should
instead ``. . . set a dollar amount ceiling on Medicare approved
chemotherapy medications and administration'' in order to ``. . . help
reduce burden on providers and patients involved in this important care
transition.'' Still another commenter reiterated a recommendation from
previous years to exclude the oral chemotherapy drug REVLIMID[supreg].
    Response: We note that as enacted by section 103 of the BBRA,
section 1888(e)(2)(A)(iii) of the Act does not authorize or provide for
setting an overall cap on chemotherapy expenditures in this context,
and instead establishes the existing approach of designating by HCPCS
code those individual ``high-cost, low probability'' chemotherapy items
and services that qualify for exclusion. Accordingly, as we noted
previously in the FY 2016 SNF PPS final rule (80 FR 46407), we are
unable to designate a chemotherapy drug for exclusion from consolidated
billing prior to the point at which it is actually assigned its own J
code. We further explained in the FY 2015 SNF PPS final rule (79 FR
45642) that
. . . the assignment of such a code has been an essential element of
identifying certain chemotherapy drugs for exclusion ever since the
BBRA first created the statutory exclusion in 1999, as reflected in
the drafting of the statutory provision itself as well as in our
periodic solicitation of ``codes'' that might meet the criteria for
exclusion.
    Regarding the oral chemotherapy drug REVLIMID[supreg], we note that
this drug has been recommended for exclusion during several previous
rulemaking cycles--most recently, in the one for FY 2019, when
commenters recommended its exclusion along with three other Part-D-only
oral chemotherapy drugs: ZYTIGA[supreg], ERLEADA[supreg], and
GLEEVEC[supreg]. In the FY 2019 SNF PPS final rule (83 FR 39181 through
39182), we stated that because the particular drugs at issue here would
not be covered under Part B, the applicable provisions at section
1888(e)(2)(A) of the Act may not provide a basis for excluding them
from consolidated billing (emphasis added), but we also cited ``the
need for further consideration of this issue.'' After further
consideration, we continue to believe that the applicable provisions at
section 1888(e)(2)(A) of the Act do not provide a basis for excluding
Part-D-only chemotherapy drugs from consolidated billing. While the
chemotherapy item exclusion itself (at section 1888(e)(2)(A)(iii)(II)
of the Act) contains no language that would serve to restrict its scope
to only those items that are payable under Part B, such restrictive
language is, in fact, set forth more broadly in section
1888(e)(2)(A)(i) of the Act, which defines the ``covered skilled
nursing facility services'' that are included in the SNF PPS per diem
rate. Under section 1888(e)(1) of the Act, the payment for all costs of
``covered skilled nursing facility services'' furnished by a SNF is
equal to (and thus included in) the SNF PPS adjusted per diem rate.
Section 1888(e)(2)(A)(i) of the Act, in turn, defines the term
``covered skilled nursing facility services'' in subclause (I) as Part
A post-hospital extended care services (SNF services) as defined in
section 1861(i) of the Act, and in subclause (II) as ``all items and
services (other than items and services described in clauses (ii),
(iii), and (iv)) for which payment may be made under Part B'' and which
are furnished during the course of a Medicare-covered SNF stay
(emphasis added). Accordingly, while therapeutic drugs such as the ones
at issue here would fall within the scope of the Part A SNF bundle as
referenced in subclause (I) above, the only items and services that
potentially could be carved out from that bundle under subclause (II)
above would be those that otherwise would be separately payable under
Part B. Further, as noted in the FY 2019 SNF PPS final rule (83 FR
39181), while section 1861(s)(2)(Q) of the Act does include a specific
Part B benefit category for oral chemotherapy drugs, coverage under
that benefit is restricted to those with the same indication and active
ingredient(s) as a covered non-oral anti-cancer drug, which is not the
case for the specific drugs in question. Moreover, as noted in the FY
2006 SNF PPS final rule (70 FR 45049), expanding the existing statutory
drug coverage available under Part B to include such drugs is not
within our authority. In this context, we further note that section 410
of the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003)--the same
legislation that created the Part D drug benefit--also amended section
1888(e)(2)(A) of the Act by adding a new subclause (iv) that excluded
certain Part B Rural Health Clinic and Federally Qualified Health
Center services from consolidated billing. At the same time, the
accompanying legislative history (House Ways and Means Comm. Rep. No.
108-178, Part 2 at 209) specifically reaffirmed the Part-B-only nature
of the consolidated billing exclusions by noting that ``Certain
services and items provided a SNF resident . . . are excluded from the
SNF PPS and paid separately under Part B'' (emphasis added). Similar
language also appears in the MMA's Conference Report (H. Conf. Rep. No.
108-391 at 640-41). Finally, it is also worth bearing in mind in this
context that the PDPM will introduce for the first time a separate SNF
payment component specifically for non-therapy ancillary (NTA)
services. As we noted in the FY 2019 SNF PPS final rule (83 FR 39180),
in accounting more accurately for the costs of NTA services such as
drugs, the PDPM model has the potential to ameliorate some of the
concerns about the adequacy of payment for drugs furnished in the SNF
setting.
3. Payment for SNF-Level Swing-Bed Services
    Section 1883 of the Act permits certain small, rural hospitals to
enter into a Medicare swing-bed agreement, under which the hospital can
use its beds to provide either acute- or SNF-level care, as needed. For
critical access hospitals (CAHs), Part A pays on a reasonable cost
basis for SNF-level services furnished under a swing-bed agreement.
However, in accordance with section 1888(e)(7) of the Act, SNF-level
services furnished by non-CAH rural hospitals are paid under the SNF
PPS, effective with cost reporting periods beginning on or after July
1, 2002. As explained in the FY 2002 final rule (66 FR 39562), this
effective date is consistent with the statutory provision to integrate
swing-bed rural hospitals into the SNF PPS by the end of the transition
period, June 30, 2002.
    Accordingly, all non-CAH swing-bed rural hospitals have now come
under the SNF PPS. Therefore, all rates and wage indexes outlined in
earlier sections of this final rule for the SNF PPS also apply to all
non-CAH swing-bed rural hospitals. As finalized in the FY 2010 SNF PPS
final rule (74 FR 40356 through 40357), effective October 1, 2010, non-
CAH swing-bed rural hospitals are required to complete an MDS 3.0
swing-bed assessment which is limited to the required demographic,
payment, and quality items. As discussed in the FY 2019 SNF PPS final
rule (83 FR 39235), revisions were made to the swing bed assessment in
order to support implementation of PDPM, effective October 1, 2019. A
discussion of the assessment schedule and the MDS effective beginning
FY 2020 appears in the FY 2019 SNF PPS final rule (83 FR 39229 through
39237). The latest changes in the MDS for swing-bed rural hospitals
appear on the SNF PPS website at http://www.cms.gov/
[[Page 38745]]
Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/index.html.
    A commenter submitted the following comment related to the proposed
rule's discussion of payment for SNF-level swing-bed services. A
discussion of that comment, along with our response, appears below.
    Comment: One commenter suggested that exempting the swing-bed
services of CAHs from the SNF PPS creates a discrepancy in payment for
comparable services between the CAH and any area SNFs which are not so
exempted, to the SNF's disadvantage. The commenter urged CMS to seek
statutory authority either to pay for CAH swing-bed services under the
SNF PPS, or to adjust Medicare payments for those rural SNFs located in
the same geographic area as a swing-bed CAH.
    Response: We note that as originally enacted in section 4432 of the
BBA 1997, the SNF PPS applied uniformly to all providers of extended
care services under Part A, including SNFs themselves along with swing-
bed CAHs as well as rural (non-CAH) swing-bed hospitals. However, the
Congress subsequently enacted legislation in section 203 of the BIPA
that specifically excluded swing-bed CAHs from the SNF PPS (see Sec.
1888)(e)(7)(C) of the Act), thus establishing that swing-bed CAHs are
to be exempted from the SNF PPS while leaving this payment methodology
in place for the other facilities, including rural SNFs. Accordingly,
CMS cannot adjust Medicare payments for rural SNFs located in the same
geographic area as a swing-bed CAH to provide for similar payments.
D. Issues Relating to PDPM Implementation
1. Revised Group Therapy Definition
    As set forth in the FY 2019 SNF PPS final rule (83 FR 39162),
effective October 1, 2019 under the PDPM, patients will be classified
into case-mix groups under each therapy component based on patient
characteristics rather than using the volume of therapy services
furnished to the patient as the basis for classification. Additionally,
as discussed in the FY 2019 SNF PPS final rule (83 FR 39237 through
39243), we finalized a combined limit on concurrent and group therapy
furnished to a patient, specifically that, for each therapy discipline,
no more than 25 percent of the therapy services furnished to a patient
in a covered Medicare Part A stay may be in a group or concurrent
setting. Given these policy changes relating to therapy classification
and therapy provision under the PDPM, as well as recent efforts to
increase standardization across PAC settings, we believed it was
appropriate to evaluate other policies associated with therapy under
PDPM to determine if other policies should be revised as well.
    In the FY 2012 SNF PPS final rule (76 FR 48511 through 48517), we
finalized changes relating to the definition of group therapy and
payment of group therapy services, specifically to define group therapy
as the practice of one therapist or therapy assistant treating four
patients at the same time while the patients are performing either the
same or similar activities. In the FY 2012 SNF PPS final rule (76 FR
48511), we noted that, using our STRIVE data as a baseline, we
identified under RUG-IV two significant changes in provider behavior
related to the provision of therapy services to Medicare beneficiaries
in SNFs. First, we saw a major decrease in the amount of concurrent
therapy (that is, therapy provided to two patients by one therapist or
therapy assistant doing different activities) performed in SNFs, the
minutes for which are divided between the two concurrent therapy
participants when determining the patient's appropriate RUG
classification. At the same time, we found a significant increase in
the amount of group therapy services, which were not subject to the
allocation requirement. Given this increase in group therapy services,
we expressed concern that the method for reporting group therapy on the
MDS created an inappropriate payment incentive to perform the group
therapy in place of individual therapy, because the method of reporting
group therapy time did not require allocation among patients.
    As we stated in the FY 2012 SNF PPS final rule (76 FR 48511),
because in group therapy, patients are performing similar activities,
in contrast to concurrent therapy, group therapy gives patients the
opportunity to benefit from each other's therapy regimen by observing
and interacting with one another and applying the lessons learned from
others to one's own therapy program in order to progress. At that time,
we stated that large groups, such as those of five or more
participants, can make it difficult for the participants to engage with
one another over the course of the session. In addition, we have long
believed that individual therapists could not adequately supervise
large groups, and since the inception of the SNF PPS in July 1998, we
have capped the number of residents at four. Furthermore, we believed
that groups of fewer than four participants did not maximize the group
therapy benefit for the participants. As we stated in the FY 2012 final
rule (76 FR 48511), we believed that in groups of two or three
participants, the opportunities for patients in the group to interact
and learn from each other are significantly diminished given the small
size of the group. Thus, we revised the definition of group therapy to
require a group size for the SNF setting of exactly four patients,
which we believed was the size that permits the therapy participants to
derive the maximum benefit from the group therapy setting.
    Since that time, we have monitored group therapy utilization and
found that, as discussed in the FY 2019 SNF PPS final rule (83 FR 39237
through 39238), group therapy represents a very small proportion of
therapy provided to SNF patients. Further, as discussed in the FY 2019
SNF PPS final rule (83 FR 39240 through 39241), some commenters
suggested that we revise the definition of group therapy to include two
to six participants doing the same or similar activities, as this would
better align with the Inpatient Rehabilitation Facility (IRF) setting
and allow increased flexibility so that patients in smaller SNFs,
presumably where a group of exactly four patients may be difficult to
attain, could utilize and benefit from group therapy. In our response
to these comments, in the FY 2019 SNF PPS final rule (83 FR 39241), we
stated that we may consider changing the definition of group therapy in
future rulemaking.
    In the past we stated our concern that a group that consisted of
more than 4 participants would not allow for adequate supervision of
each participant as well as cause difficulty for participants to engage
with one another in the most effective way. Conversely, we maintained
that a group of fewer than 4 participants would not allow for effective
interaction to best achieve the goals of a group. For these reasons, we
defined group therapy as exactly 4 participants. However, as we noted
in the FY 2020 SNF PPS proposed rule (84 FR 17634), based on our review
of the use of group therapy in the IRF and outpatient settings where
the definition of group therapy is less restrictive than the current
definition under the SNF PPS, we have found that therapists do seem
capable of managing groups of various sizes. We stated that, based on
this review, we believe therapists have the clinical judgment to
determine whether groups of different sizes would clinically benefit
their patients, which they should be able to demonstrate with adequate
documentation. We stated in the proposed rule that patients can often
[[Page 38746]]
benefit from the psycho-social aspect of groups, and in some
situations, a group of six participants is not too large to provide
that benefit to participants. For example, a cooking activity which
will provide very functional therapy for patients planning to return
home can be done in a group of six that will enhance the patient's
psycho-social experience in the SNF.
    Alternatively, we stated that a group of 2-3 patients can be
clinically useful for certain patients as well. For example, a group of
2-3 patients who have pragmatic language difficulties following a
stroke or head injury could very well benefit from a small
communication group to work on the social aspects of language together
without the concern of distraction that a larger group might cause.
Thus, we stated in the proposed rule that while we continue to maintain
minimal concerns that some groups may be either too small or too large
to allow for effective interaction, we believe that the potential
clinical benefits of various size groups outweigh our concerns, and
that it would be appropriate to allow therapists greater flexibility to
perform therapy in groups of different sizes.
    In light of our discussion above and the comments in the FY 2019
SNF PPS final rule, and to align the SNF PPS more closely with other
settings, in the FY 2020 SNF PPS proposed rule (84 FR 17634), we
proposed to adopt a new definition of group therapy for use under PDPM,
effective October 1, 2019, as further discussed below. As discussed in
the FY 2020 SNF PPS proposed rule, in an effort to support CMS'
crosssetting initiatives under the IMPACT Act and Meaningful Measures
Initiative, we looked at ways to align the definition of group therapy
used under the SNF PPS more closely with the definitions used within
the outpatient setting covered under Medicare Part B and under the IRF
PPS, as this type of standardization would reduce administrative burden
on providers by utilizing the same or similar definitions across
settings. For group therapy in the outpatient setting, the Medicare
Benefit Policy Manual, Chapter 15, Section 230 states that contractors
pay for outpatient physical therapy services (which includes outpatient
speech-language pathology services) and outpatient occupational therapy
services provided simultaneously to two or more individuals by a
practitioner as group therapy services (CPT code 97150). This manual
section further states that the individuals can be, but need not be,
performing the same activity. In addition, this section states that the
physician or therapist involved in group therapy services must be in
constant attendance, but one-on-one patient contact is not required.
Under the IRF PPS, the definition of group therapy (found in Section 2
of the IRF PAI Training Manual, https://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/Downloads/IRFPAI-1_5-2_0.zip) is the provision of therapy services by one licensed or
certified therapist (or licensed therapy assistant, under the
appropriate direction of a licensed or certified therapist) treating
two to six patients at the same time who are performing the same or
similar activities.
    As discussed in the FY 2020 SNF PPS proposed rule (84 FR 17634), we
considered using the same definition as used in the outpatient setting
covered under Medicare Part B, which is two or more patients performing
either the same or different activity, as opposed to the IRF definition
of two to six patients performing the same or similar activities.
However, we stated that given the greater degree of similarity between
the IRF and SNF settings in terms of the intensity of therapy and
patient acuity, we believe that the IRF PPS definition would be more
appropriate in the SNF setting. Thus, for the reasons discussed
previously and in the FY 2020 SNF PPS proposed rule (84 FR 17634), we
proposed to define group therapy in the SNF Part A setting as a
qualified rehabilitation therapist or therapy assistant treating two to
six patients at the same time who are performing the same or similar
activities. We stated in the proposed rule that we believe this
definition would offer therapists more clinical flexibility when
determining the appropriate number for a group, without compromising
the therapist's ability to manage the group and the patient's ability
to interact effectively and benefit from group therapy.
    In the FY 2020 SNF PPS proposed rule (84 FR 17635), we stated that
we continue to believe that individual therapy is the preferred mode of
therapy provision and offers the most tailored service for patients. As
we stated in the FY 2012 proposed rule (76 FR 26387), while group
therapy can play an important role in SNF patient care, group therapy
is not appropriate for either all patients or for all conditions, and
is primarily effective as a supplement to individual therapy, which we
maintain should be considered the primary therapy mode and standard of
care in therapy services provided to SNF residents. Additionally, we
stated that we continue to maintain that when group therapy is used in
a SNF, therapists must document its use in order to demonstrate why it
is the most appropriate mode of therapy for the patient who is
receiving it. As stated in the FY 2012 SNF PPS proposed rule (76 FR
26388) regarding group therapy documentation, because group therapy is
not appropriate for either all patients or all conditions, and in order
to verify that group therapy is medically necessary and appropriate to
the needs of each beneficiary, SNFs should include in the patient's
plan of care an explicit justification for the use of group, rather
than individual or concurrent, therapy. This description should
include, but need not be limited to, the specific benefits to that
particular patient of including the documented type and amount of group
therapy; that is, how the prescribed type and amount of group therapy
will meet the patient's needs and assist the patient in reaching the
documented goals. In addition, we believe that the above documentation
is necessary to demonstrate that the SNF is providing services to
attain or maintain the highest practicable physical, mental, and
psychosocial well-being of each resident in accordance with section
1819(b)(2) of the Act.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Revised Group Therapy Definition. A discussion
of these comments, along with our responses, appears below.
    Comment: The majority of the comments received supported changing
the definition of group therapy to treatment by a qualified therapist
or therapy assistant of two to six patients at the same time who are
performing the same or similar activities. Several commenters noted
agreement that the increased flexibility afforded by the revised
definition will offer therapists more clinical flexibility when
determining what mode of therapy would best suit their patients. Other
commenters stated that the revised definition would allow smaller SNFs
with fewer patients to treat a smaller group in a therapy session (for
example, two patients) and that they believe they were unable to
provide this when group therapy was defined as four patients.
Commenters approved of the standardization across post-acute care
settings and appreciated the synchronization between the Inpatient
Rehabilitation Facility (IRF) definition and the proposed SNF
definition of group therapy. Additionally, one commenter pointed out
that the increased latitude in the provision of group therapy will
better allow patients to gradually progress from one-to-one
[[Page 38747]]
treatment into a family or community setting which better simulates a
typical living environment and will better provide a transition model
from the short term SNF stay. Several of the commenters who supported
the proposal noted that individual therapy is still the most preferred
mode of therapy to provide to SNF patients and expressed that although
they were in agreement with the change in definition of group therapy,
their support should not be conflated with any thought that individual
therapy isn't the most appropriate mode of therapy.
    Response: We are pleased that so many commenters supported the
change to the definition of group therapy in the SNF setting. We agree
that the increased flexibility for therapists to determine the
appropriate number of patients in a group is appropriate and will allow
therapists to better meet the clinical needs of their patients.
Further, we believe that this change is a positive part of CMS' mission
to reduce administrative burden on providers by utilizing the same or
similar definitions across settings. We agree with the commenter who
discussed that the ability to use different modes of therapy may better
simulate real-life situations for many patients. We do, however,
believe that, as with all clinical situations, there should not be a
one-size-fits-all approach--which is entirely consistent with our
emphasis on the critical importance of addressing each patient's
specific condition and individualized treatment needs. While utilizing
different modes of therapy may be a good way to transition some
patients back to their home environments, it may be inappropriate for
other patients. We continue to believe and agree with the commenters
who stated that individual therapy is the most preferred mode of
therapy to use in the SNF. While group therapy can play an important
role in SNF patient care for certain patients or for certain
conditions, it is primarily a supplement to individual therapy, and we
continue to maintain that a therapist providing one-to-one care with
his or her full attention on one patient should be considered the
primary mode of therapy and standard of care.
    Comment: One commenter requested further clarification regarding
documentation requirements described in the proposed rule. This
commenter questioned whether documentation requires a new plan of care
to incorporate group therapy after an evaluation.
    Response: We note that there are no new documentation requirements
regarding group therapy. In the proposed rule, we simply reiterated
existing CMS policy pertaining to documentation. As stated in the FY
2012 proposed rule (76 FR 26388) regarding group therapy documentation,
. . . because group therapy is not appropriate for either all
patients or all conditions, and in order to verify that group
therapy is medically necessary and appropriate to the needs of each
beneficiary, SNFs should include in the patient's plan of care an
explicit justification for the use of group, rather than individual
or concurrent, therapy. This description should include, but need
not be limited to, the specific benefits to that particular patient
of including the documented type and amount of group therapy; that
is, how the prescribed type and amount of group therapy will meet
the patient's needs and assist the patient in reaching the
documented goals. In addition, we believe that the above
documentation is necessary to demonstrate that the SNF is providing
services to attain or maintain the highest practicable physical,
mental, and psychosocial well-being of each resident in accordance
with section 1819(b)(2) of the Act.
    If there is a change in the need for group therapy after a plan of
care is completed, we would expect that this would be reflected in the
medical record with whatever progress notes a facility requires to
adequately capture the clinical status of a patient.
    Comment: Many commenters discussed the increased value in providing
all different modes of therapy (that is, individual, concurrent, and
group therapy) to patients based on their different clinical needs.
They believe that in the strictest sense, the definition of group
therapy in the SNF setting is for payment purposes rather than clinical
purposes and that ultimately clinicians should be the ones to determine
which mode of therapy is in the best interest of each patient.
    Response: We agree that the ability to provide different modes of
therapy increases the possibility that patients will receive therapy
that is most appropriate for their individual needs based on the sound
clinical judgment of SNF therapists and therapy assistants. We also
agree that clinicians should be the ultimate deciders of which mode of
therapy is appropriate for each patient, but as we stated previously,
we continue to maintain that individual therapy should be the primary
mode of therapy and the standard of care for SNF patients. Furthermore,
we believe the implementation of PDPM will bring with it incentives to
provide less therapy in general because payment will no longer be based
on the volume of service provided, and for the sake of patients and
their needs, we have placed some limits on the size of the group to
help assure that patients are not placed in groups that are too large
and that patients continue to receive the individualized care that is
the most appropriate for them. Thus, even though the proposed
definition of group therapy is technically being used for payment
purposes, the proposed definition is also based on clinical
considerations, as we believe it is necessary to assure that patients
are receiving the best clinical care possible.
    Comment: Several commenters pointed out that because the definition
of group therapy will change simultaneously with the implementation of
PDPM, there cannot be a direct comparison between group therapy
utilization under RUG-IV and group therapy under PDPM. They noted that,
under RUG-IV, when the definition of group therapy was exactly four
patients, it was possible that patients who might have benefitted from
group therapy but whose sessions did not qualify for the strict
definition would have received individual or concurrent therapy in its
place. These commenters cautioned CMS against assuming a correlation
between an increase in group therapy usage and the implementation of
PDPM. Further, one commenter suggested that CMS delay the change in
definition of group therapy for at least 3 years until the impact of
the PDPM transition has been adequately monitored and analyzed.
    Response: We recognize that the simultaneous implementation of PDPM
and the change to the definition of group therapy means that it will be
difficult to compare RUG-IV and PDPM in terms of the impact of the PDPM
on group therapy utilization. However, we think it is important and
appropriate to move forward with the change in definition. This change
will benefit SNF patients by providing therapists with increased
flexibility to determine the size of groups thereby enhancing the
therapists' ability to accommodate the needs of different patients with
different conditions. We do not believe a delay in implementation of
the definition change is an appropriate solution. Given the significant
behavioral changes that may be seen under PDPM, specifically a
reduction in therapy provision generally and an increase in use of
group therapy, we put in place several safeguards or monitoring
mechanisms, such as the required PPS discharge assessment that will
record the amount of therapy provided during a SNF stay as well as act
as a tool that will calculate the percentage of group therapy provided.
We continue to expect that therapists will use clinical judgment to
determine the appropriate frequency, duration, and
[[Page 38748]]
modality of therapy services for SNF patients and will do so based on
sound clinical reasoning and not financial motives. We also expect that
these therapists will document the use of group therapy for each
patient they treat in a group in a way that clearly shows that group
therapy is the most appropriate mode of therapy to be used in each
case. Finally, we plan to monitor closely how the provision of therapy
changes under PDPM and may consider additional policy development in
the future to address any adverse trends we identify.
    Comment: Several commenters did not support the proposal to change
the definition of group therapy. These commenters believe that this
definition goes against the long held CMS belief that individual
therapists cannot supervise large groups of patients and that small
groups of two or three patients do not provide an adequate opportunity
for patients to interact with each other to maximize the benefit of a
group. This group of commenters urged CMS to keep the current
definition of group therapy. These commenters also expressed concern
that the revised definition of group therapy will incentivize SNFs to
provide more group therapy, possibly to the detriment of their
patients. In general, these commenters are concerned that with the PDPM
changes, SNFs already have too many incentives to provide group therapy
in place of individual therapy and that the change in the definition of
group therapy is one more factor that will result in care decisions
being made for financial reasons rather than clinical reasons. They
stated that PDPM will incentivize SNFs to provide less therapy in
general and the additional change to group therapy will inhibit SNFs
from providing the individualized therapy that the majority of SNF
patients require. These commenters requested that CMS closely monitor
the 25 percent combined cap on group and concurrent therapy that will
go into effect upon implementation of PDPM to protect patients from
receiving inappropriate amounts of group and concurrent therapy and to
consider adding a penalty to providers who do not comply with the
limit.
    Response: We appreciate the concern that the commenters expressed
with regard to the change in definition of group therapy. We are aware
that in the past, we maintained the position that large groups were
difficult to supervise and could make it difficult for patients to
engage with one another and that small groups did not offer adequate
opportunity to effectively interact or maximize the benefit of the
group. However, as we discussed in the FY 2020 SNF PPS proposed rule
(84 FR 17634), we reviewed the usage of group therapy sizes in the IRF
setting and we found that therapists are capable of using their
clinical judgment to determine whether a group is too large or small
and can manage groups of various sizes, and we expect therapists to
adequately document the basis for their clinical decisions.
Additionally, as we stated in the proposed rule, groups of various
sizes can provide psycho-social benefits to patients, and thus we
believe the increased flexibility provided to therapists to furnish
therapy through different size groups will be clinically beneficial to
patients.
    We understand that in some SNFs, staffing issues may make it
difficult to adequately and effectively supervise larger groups.
However, there are many cases where this is not an issue and we do not
want to prohibit SNFs from providing valuable therapy in larger groups
if they can appropriately staff them. Additionally, these larger groups
are an opportunity to utilize therapy students as extra sets of hands,
eyes, and observers and can work as a way to offer therapy students
valuable teaching and patient care time to assist them in maximal
learning. Conversely, we do not want to prevent SNFs that have fewer
patients with similar or the same needs from providing group therapy in
smaller groups because the definition is currently set at four
patients.
    We recognize that the change in the way we are paying for therapy
under PDPM may incentivize providers to furnish more group therapy for
financial, rather than clinical reasons, and for this reason, we put
the 25 percent combined cap into place effective October 1, 2019 as a
limit on the amount of group and concurrent therapy that may be
provided under PDPM. Ultimately though, we expect the decision on group
size (within the revised definition) will be made by qualified
therapists and therapy assistants and we expect their judgment on this
matter to be based on sound clinical rationale and not financial gain.
We believe that the judgment of the therapists and therapy assistants
will allow for appropriate decision making regarding the number of
group participants, and the combined 25 percent cap on group and
concurrent therapy will help prevent an overutilization of group
therapy under PDPM. We plan to implement a robust monitoring program to
assess compliance with the 25 percent cap, and based on our findings,
we may propose taking additional action in future rulemaking.
    Comment: Several commenters expressed concern that the definition
of group therapy as two to six patients will give providers an
incentive to place the maximum number of patients in a group in order
to exploit the financial incentives that would accompany doing so. One
commenter expressed concern that corporate rehabilitation companies
will disregard the clinical judgment of their therapists and therapy
assistants and pressure them into providing groups of five or six at
all times for financial gain. This commenter also stated the concern
that rehabilitation companies may relax their standards for what is
considered a group and pressure their therapists into providing groups
that are less than clinically sound.
    Response: We appreciate the commenters' concern that the proposed
change in the definition of group therapy may give providers an
incentive to place the maximum number of patients in a group for
financial reasons. We also appreciate the concern of the commenter who
stated that it is possible that corporate rehabilitation companies will
pressure therapists into providing group therapy in groups with as many
patients as possible and that this might not be appropriate as group
therapy at all times. As we have stated previously, therapists treating
SNF patients should use their own clinical judgment to determine the
appropriate frequency, duration, and modality of therapy services and
the size of a therapy group based on the individual needs of each
patient. Financial motives should not override the clinical judgment of
a therapist or therapy assistant or pressure a therapist or therapy
assistant to provide less than appropriate therapy, including putting
patients in large groups that are not clinically appropriate for those
patients.
    Comment: Several commenters suggested that CMS consider revising
the definition of group therapy to two to four patients doing the same
or similar activity. These commenters explained that doing so would
still provide therapists an appropriate level of clinical flexibility
while preventing SNFs from including a very large number of patients in
a group only for financial reasons.
    Response: We appreciate the suggestion of revising the definition
of a group to two to four patients. If, after monitoring the provision
of group therapy under the PDPM, we believe this policy would be more
appropriate in the SNF setting, we will consider it for future rule-
making. As stated above and the in the FY 2020 SNF PPS proposed rule
(84 FR 17634), we believe that defining group therapy as therapy
[[Page 38749]]
provided to groups of 2 to 6 patients at the same time who are
performing the same or similar activities would provide therapists with
an appropriate amount of flexibility to meet the clinical needs of
their patients without compromising the therapist's ability to manage
groups and the patient's ability to interact effectively and benefit
from the group. We expect that therapists will use their professional
judgment to determine the most appropriate group size within the bounds
of that definition to maximize the benefit to each patient in the group
session.
    Comment: Several commenters noted that revising the definition of
group therapy to better align with other post-acute care settings is
``misguided''. These commenters stated that the post-acute care
settings provide different levels of care and that the IRF setting,
specifically, is meant to provide a more intense level of therapy than
other settings, and that it would be flawed to try to synchronize the
definition of group therapy across these settings that have different
coverage requirements and patients with different acuity levels.
    Response: We disagree with the notion that the change in the
definition of group therapy to better align with other post-acute
settings is ``misguided.'' Anecdotally, providers have stated that the
acuity of SNF patients has increased over the years and that the level
of care and therapy they require is comparable to that of IRF
residents. Additionally, under RUG-IV, the majority of SNF therapy
patients have been placed in the Ultra High therapy group, receiving at
least 720 minutes of therapy a week. We do not believe that this level
of therapy is very different from the intense level of therapy that is
occurring in IRFs. We acknowledge that the higher acuity and need for
an intense level of therapy does not apply to all SNF patients, but we
expect the therapists and assistants who will be providing the group
therapy will determine the appropriate intensity of therapy for each
patient. Additionally, we continue to maintain that synchronization of
the group therapy definition between settings will ease provider burden
and help achieve CMS' goal of cross-setting alignment in this aspect.
    Comment: Several commenters expressed concern that PDPM will
inadvertently cause therapy students to lose out on opportunities for
supervision and training. These commenters are concerned that
maintaining compliance with the 25 percent combined limit on concurrent
and group therapy may encourage therapists and assistants to forego
supervising therapy students because doing so would add additional
burden to their facilities. These commenters stated that this would
affect the ability of students to get the valuable clinical training
required to adequately treat geriatric patients in the SNF setting. One
commenter explained that the current policy of considering a student
clinician as an extension of the therapist or assistant who is training
the student, as described in the FY 2012 final rule (76 FR 48511),
(that is, the time the student spends with a patient is coded as if it
were the supervising therapist or therapy assistant alone providing the
therapy) should not be necessary under PDPM as it is under RUG-IV. This
commenter stated that, because under the PDPM therapy minutes are no
longer the primary driver for payment, this should not be a necessary
aspect of the policy. One commenter recommended that CMS apply the 25
percent group and concurrent therapy limit at the facility level rather
than individual level, and stated that doing this would not only
maintain consistency of data comparison between RUG-IV and PDPM but
also reduce the concerns with student supervision described above by
creating a more flexible environment for treatment. Several commenters
requested reiteration of CMS guidance regarding appropriate and
effective use of student clinicians for group therapy.
    Response: We do not agree with the comment that our policy under
which the therapy student acts as an extension of the supervising
therapist is no longer necessary under PDPM, as it is under RUG-IV, due
to the discontinued use of therapy minutes as a primary driver of
payment under PDPM. First, therapy minutes are still used under PDPM as
part of calculating compliance with the cap on concurrent and group
therapy. As such, maintaining this policy will ensure that therapy
student time is reflected accurately and consistently with how it is
reported under RUG-IV, to ensure an appropriate comparison between the
two models. Additionally, we believe it is appropriate to maintain this
policy under PDPM because it reflects the responsibility of the
supervising therapist for the actions and treatments furnished by the
student.
    Further, we do not agree that PDPM will cause SNFs not to offer
therapy students adequate supervision and training. Specifically, we do
not agree that the combined 25 percent limit on group and concurrent
therapy will create an extra burden that impedes therapists and therapy
assistants from supervising students, and we believe that SNF
therapists and therapy assistants will continue to be able to teach,
train, and supervise therapy students in the same way under PDPM as
they have in the past. As we have discussed previously (84 FR 17634),
our data show that group therapy represents a very small proportion of
therapy provided to SNF patients. Thus, the 25 percent limit on group
and concurrent therapy should not adversely affect opportunities for
student supervision and training. As stated in the FY 2019 SNF PPS
final rule (83 FR 39242):
. . . as mentioned above, our most recent (FY 2017) data show that
individual therapy was provided 99.77 percent of the time, meaning
that group and concurrent therapy combined was reported as having
been provided 0.23 percent of the time. It concerns us that
commenters have stated that they are providing so much concurrent
therapy with students that the 25 percent cap would be too low for
them, because this would suggest that either the comments were
provided mistakenly or that facilities are falsely reporting
concurrent therapy as individual therapy. While we agree with
commenters that the opportunity to supervise student therapists in
SNFs is valuable to the education of future therapists and
assistants, our data indicate that a 25 percent combined cap on
group and concurrent therapy should not deter facilities from taking
more therapy students.
    We do not agree with the suggestion to apply the 25 percent limit
on group and concurrent therapy at a facility level. The notion that
doing so would maintain consistency of data comparison between RUG-IV
and PDPM is incorrect since we currently monitor data at the patient
level under RUG-IV, not at the facility level. We also do not believe
that we should apply the 25 percent limit at the facility level
because, if we were to apply the 25 percent limit at a facility level,
a large number of patients may receive 100 percent group or concurrent
therapy and we do not believe that would be clinically appropriate. As
we have stated previously, we believe that individual therapy is the
preferred mode of therapy. The 25 percent limit on group and concurrent
therapy underscores this. Anecdotally, we have been told by an industry
group that they would advise their facilities to give as much group and
concurrent therapy as possible based on the limit we set for group and
concurrent therapy, so that if the limit were 50 percent, they would
advise their facilities to give 50 percent group and concurrent
therapy. This group informed us that they plan to advise their
facilities to furnish 25 percent of all therapy as group and concurrent
therapy. We note that we do not believe it would be appropriate to
automatically provide the maximum amount of group and concurrent
therapy
[[Page 38750]]
permitted under the percent cap set by Medicare without considering the
individual clinical needs of each patient. As we stated previously, we
expect therapists to determine the frequency, duration, and modality of
therapy based on sound clinical reasoning and the individual needs of
each patient. Further, as we stated above and in the FY 2020 SNF PPS
proposed rule (84 FR 17635), we continue to believe that individual
therapy is the preferred mode of therapy provision and should be
considered the standard of care in therapy services provided to SNF
residents. Regarding our guidance addressing the most appropriate use
of student clinicians for group therapy, we have updated the MDS RAI
manual in Chapter 3 Section O to include in it a revised explanation of
how the time during which therapy students furnish either concurrent or
group therapy should be captured on the MDS; however, we continue to
believe the most appropriate ways to receive guidance on how to best
incorporate students in the group and concurrent therapy process would
come from the therapy associations and clinical departments of SNFs, as
has been done in the past.
    Comment: Several commenters requested that CMS discuss whether
there will be a penalty for facilities that exceed the 25 percent
concurrent and group therapy limit in the future. Commenters explained
that the non-fatal warning is not a strong enough incentive for
facilities to comply with the limit.
    Response: We plan on monitoring the usage of group and concurrent
therapy as well as looking at clinical outcomes. If the results of our
monitoring efforts indicate substantial non-compliance with the 25
percent limit, we may consider taking additional action in future
rulemaking. However, we expect that providers will pay close attention
to the warning provided on their validation reports and be aware that
we are monitoring their use of group and concurrent therapy as well.
    After considering the comments above, for the reasons set forth in
this final rule and in the FY 2020 SNF PPS proposed rule, we are
finalizing our revision to the definition of group therapy as proposed
without modification. Effective October 1, 2019, under the SNF PPS,
group therapy will be defined as a qualified rehabilitation therapist
or therapy assistant treating two to six patients at the same time who
are performing the same or similar activities.
2. Updating ICD-10 Code Mappings and Lists
    In the FY 2019 SNF PPS final rule (83 FR 39162), we finalized the
implementation of PDPM, effective October 1, 2019. The PDPM utilizes
ICD-10 codes in several ways, including to assign patients to clinical
categories used for categorization in the PT, OT, and SLP components,
as well as identifying certain comorbidities relevant for
classification under the SLP and NTA components. The ICD-10 mappings
and lists that would be used under PDPM, once implemented, are
available on the PDPM website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html.
    Each year, the ICD-10 Coordination and Maintenance Committee, a
federal interdepartmental committee that is chaired by representatives
from the National Center for Health Statistics (NCHS) and by
representatives from CMS, meets biannually and publishes updates to the
ICD-10 medical code data sets in June of each year. These changes
become effective October 1 of the year in which these updates are
issued by the committee. The ICD-10 Coordination and Maintenance
Committee also has the ability to make changes to the ICD-10 medical
code data sets effective on April 1, but has not yet done so.
    We stated in the FY 2020 SNF PPS proposed rule (84 FR 17635) that
as providers are required to follow the most up to date coding guidance
issued by this committee in accordance with 45 CFR part 162, subpart J,
it is essential that we be able to update our code mappings and lists
consistent with the latest coding guidance. Therefore, to ensure that
the ICD-10 mappings and lists used under PDPM reflect the most up to
date codes possible, we proposed to update any ICD-10 code mappings and
lists used under PDPM, as well as the SNF GROUPER software and other
such products related to patient classification and billing, through a
subregulatory process which would consist of posting updated code
mappings and lists on the PDPM website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html. More specifically,
we stated in the proposed rule that, beginning with the updates for FY
2020 (see discussion below), nonsubstantive changes to the ICD-10 codes
included on the code mappings and lists under the PDPM would be applied
through the subregulatory process described above, and substantive
revisions to the ICD-10 codes on the code mappings and lists used under
the PDPM would be proposed and finalized through notice and comment
rulemaking.
    As discussed in the proposed rule (84 FR 17635), nonsubstantive
changes would be limited to those specific changes that are necessary
to maintain consistency with the most current ICD-10 medical code data
set, which Medicare providers are generally required to use. We stated
that our intent in applying these nonsubstantive changes through the
proposed subregulatory process would be to keep the same conditions in
the PDPM clinical categories and comorbidities lists, but ensure that
the codes used to identify those conditions are synchronized with the
most current ICD-10 medical code data set. For example, to the extent
that the ICD-10-CM Coordination and Maintenance Committee changes an
ICD-10 code for a comorbid condition on our comorbidities lists into
one or more codes that provide additional detail, we would update the
SNF GROUPER software and ICD-10 mappings and lists on the CMS website
to reflect the new codes through the above-referenced subregulatory
process. By contrast, we stated that we would use notice and comment
rulemaking to make substantive changes to the ICD-10 code mappings and
lists under the PDPM. For the purposes of this policy, we stated that a
substantive change would be defined simply as any change that does not
fall within the definition of a nonsubstantive change--that is, changes
that go beyond the intention of maintaining consistency with the most
current ICD-10 medical code data set. For example, changes to the
assignment of a code to a comorbidity list or other changes that amount
to changes in policy would be substantive changes. Taking the example
above, we explained in the proposed rule that there may be situations
in which the addition of one or more of these new codes to the list of
comorbidities may not be appropriate. One such instance would be when
the ICD-10 code for a particular condition is divided into two more
detailed codes, one of which represents a condition that generally is
predictive of the costs of care in a SNF and one of which is not. We
stated that we would propose through notice and comment rulemaking to
delete the code that does not reflect increased costs of care in a SNF
from the list of comorbidities in the SNF GROUPER software because
removing the code would constitute a substantive change. We proposed to
indicate all changes to
[[Page 38751]]
codes in the GROUPER software by posting a complete ICD-10 mapping
table, including new, discontinued, and modified codes, on the PDPM
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html. We also proposed to report the complete list
of ICD-10 codes associated with the SNF PDPM clinical categories and
SLP/NTA comorbidities in the SNF GROUPER documentation, which is also
posted on the PDPM website. We stated that all changes would be
included in these documents, with substantive changes being included
only after being finalized through notice and comment rulemaking.
    As discussed in the proposed rule (84 FR 17635 through 17636), we
believe that the proposed subregulatory update process (by which
nonsubstantive changes to the ICD-10 code mappings and lists used under
PDPM as well as the SNF GROUPER software and other such products
related to patient classification and billing would be posted on the
CMS websites specified above), is the best way for us to convey
information about changes to the ICD-10 medical code data set that
affect the code mappings and lists used under the PDPM. We stated that
we believe the proposed subregulatory process would help ensure
providers have the most up-to-date information as soon as possible, in
the clearest and most useful format, as opposed to publishing each
nonsubstantive change to the ICD-10 codes in a rule after notice and
comment rulemaking.
    Additionally, we explained in the proposed rule (84 FR 17636) that
the proposed subregulatory process is in alignment with similar
policies in the SNF PPS and the IRF PPS settings. For example, the SNF
PPS already uses a subregulatory process to make nonsubstantive updates
to the list of Healthcare Common Procedure Coding System (HCPCS) codes
that are used in determining the applicability of the consolidated
billing (CB) provision of the SNF PPS to a given service, as discussed
in section III.C.2 of this final rule. We post routine annual updates
to the lists of codes that are included or excluded from CB on the SNF
CB website at https://www.cms.gov/Medicare/Billing/SNFConsolidatedBilling/index.html. The new codes identified in each
update essentially describe the same overall set of services that are
excluded from CB. No additional service categories are added by these
routine updates; that is, these updates are necessary because of
changes to the coding system, not because the basic service categories
that are excluded from CB are themselves being redefined. We stated in
the proposed rule that we believe the proposed subregulatory process to
update ICD-10 codes associated with PDPM clinical categories and
comorbidity lists is appropriate given that it is consistent with this
subregulatory process already in use under the SNF PPS to make
nonsubstantive coding updates.
    Likewise, we explained in the proposed rule (84 FR 17636) that the
IRF PPS also utilizes processes similar to that proposed here. In the
FY 2007 IRF PPS final rule (71 FR 48360 through 48361), we implemented
a similar subregulatory updating process for the IRF tier comorbidities
list, and the FY 2018 IRF PPS final rule (82 FR 36267 through 36269)
established a similar process for updating the ICD-10 code lists used
for the IRF presumptive compliance methodology. Both the IRF tier
comorbidities list and the IRF presumptive compliance methodology also
use ICD-10 codes. Therefore, we stated that we believe the
subregulatory process proposed in the proposed rule is appropriate
because it is also consistent with processes used in another Medicare
setting.
    We proposed (84 FR 17636) that this subregulatory process for
updating the ICD-10 codes used under the PDPM would take effect
beginning with the updates for FY 2020. We further stated that the
proposed ICD-10 code mappings and lists for use under the PDPM were
available for download from the SNF PPS website (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html). We stated
that these mappings and lists reflect the adoption of the ICD-10
Coordination and Maintenance Committee's draft changes to the ICD-10
medical code data sets, effective October 1, 2018. Furthermore, we
explained in the proposed rule that the version of these mappings and
lists that is finalized in conjunction with the FY 2020 SNF PPS final
rule would constitute the baseline for any future updates to the
mappings and lists using the proposed process described above.
    Commenters submitted the following comments related to the proposed
rule's discussion of Updating ICD-10 Code Mappings and Lists. A
discussion of these comments, along with our responses, appears below.
    Comment: The majority of commenters expressed support for the
proposed subregulatory process for updating ICD-10 mappings. Several
commenters noted that the proposed method would support the timely
implementation of changes in coding, while ensuring additional
consideration is given to substantive changes that amount to a change
in policy. Only one commenter stated a preference for notice and
comment rulemaking for all changes.
    Response: We agree with the majority of commenters that the
proposed subregulatory method is the best way to ensure the timely
implementation of nonsubstantive changes in ICD coding under the PDPM.
With regard to the comment that we utilize notice and comment
rulemaking to implement all changes to ICD-10 code mappings and lists
under the PDPM, we believe that this could represent a potential
program vulnerability, as SNF providers would be prevented from
utilizing valid ICD-10 codes under the SNF PPS pending the completion
of the notice and comment rulemaking process and, moreover, could be
compelled to utilize ICD-10 codes that are no longer valid due to our
inability to ensure timely updates to our code mappings and lists when
ICD-10 code revisions occur.
    Comment: A commenter requested additional guidance on what
constitutes a ``substantive'' change for the purposes of the proposed
subregulatory process to update the ICD-10 code mappings and lists
associated with the SNF PDPM.
    Response: A ``substantive'' change would be any change to the
mappings and lists that goes beyond the intention of maintaining
consistency with the most current ICD-10 medical code data set. Any
change that constitutes a change in policy, including changes to PDPM
clinical category assignments or to the assignment of a code to the
comorbidities list, would be considered a substantive change. For
instance, consider a hypothetical code XYZ, which is mapped to a
comorbid condition on our comorbidities list. In a revision to the ICD-
10 codes, code XYZ is split into two separate codes, XYZ.1 and XYZ.2,
providing additional detail. We would consider it a non-substantive
change to update the mappings and lists to reflect the two new codes
instead of the previous single code, and we would make this change to
the mappings and lists through the proposed subregulatory process. On
the other hand, if we believe the new code XYZ.2 is not predictive of
SNF costs of care and wish to remove the new code XYZ.2 from the
mappings and lists of PDPM comorbidities, this would be a substantive
change, because it changes a policy: Conditions previously included on
the comorbidities list under the old code XYZ would no longer be
included on the comorbidities list if we chose to remove XYZ.2.
Therefore, removing the new XYZ.2 code from the mappings and
[[Page 38752]]
lists would represent a substantive change. We would only make such a
change through notice and comment rulemaking.
    Comment: A commenter noted that the proposed rule does not clearly
state whether non-substantive changes will be made according to the
same schedule followed by the ICD-10 Coordination and Maintenance
Committee, which updates ICD-10 medical code data sets in June of each
year that then become effective in October 1 or April 1 of that year.
The commenter stated that a predictable schedule for updates is
necessary given the importance of ICD-10 codes and the associated
mappings to the determination of patient classification and the
calculation of per diem rates under PDPM. The commenter requested
further clarification on when providers can expect non-substantive
changes to be made according to the subregulatory process.
    Response: The schedule for non-substantive CMS updates to the PDPM
mappings and lists via the proposed subregulatory process will roughly
follow the same schedule currently followed by the ICD-10 Coordination
and Maintenance Committee in releasing updates to the ICD-10 medical
code data sets in June. Once we receive the revised ICD-10 code lists
from the committee, we will publish revised PDPM mappings and lists
associated with the revised code lists shortly thereafter. Further, the
revised PDPM mappings and lists would be effective at the same time as
when the revised ICD-10 codes are effective. For example, if the
revised codes are effective October 1 of a given year, than the revised
PDPM mappings and lists based on these codes would also be effective
October 1.
    Comment: Several commenters made specific suggestions regarding how
CMS should present changes made through the subregulatory process on
the CMS website to ensure that stakeholders are aware of the changes.
Commenters suggested that CMS should ensure the updates are
communicated in a timely manner, easy to locate on the website, dated
so providers are able to easily identify the most current files, and
include a summary of what changes were made. Commenters also requested
that updates include specific effective dates for the change, with such
effective dates being reasonable for SNF staff to implement.
    Response: We agree with these suggestions and note that we have
established website maintenance and design practices that already
incorporate the majority of the recommendations for presenting changes
to the information uploaded on the website. The updates to the ICD-10
mappings and lists will be posted in a timely manner, easy to locate,
dated, and accompanied by summaries of the changes and the specified
effective dates.
    Comment: Two commenters suggested that CMS send a monthly or
quarterly newsletter announcing any changes made to the ICD-10 mappings
and lists.
    Response: We currently issue the Medicare Learning Network (MLN)
newsletter and will issue an MLN article alerting providers and
stakeholders to any update to the ICD-10 mappings and lists.
    Comment: A commenter suggested that education and resources should
be made available to all members of the interdisciplinary team,
including therapy practitioners, to understand the implications of
coding on patient categories and payment.
    Response: We currently provide a number of educational materials on
the PDPM website (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html) including FAQs and fact sheets
concerning PDPM patient classification and payment categories. We will
update such materials on an ongoing basis to best serve the needs of
providers.
    Comment: Some commenters commented on an aspect of the PDPM
established in the FY 2019 SNF PPS final rule (83 FR 39162),
specifically, the use of ICD-10 codes in section I0020B to assign
patients to clinical categories used for categorization in the PT, OT,
and SLP components. Commenters noted a possible discrepancy between the
American Health Information Management Association (AHIMA) guidance and
MDS guidance with regard to how to code the ``principal diagnosis'' in
I0020B. Commenters requested that CMS work with AHIMA or other
professional coding organizations to ensure that coding instructions
for the MDS are consistent with all relevant ICD-10 coding rules and
guidelines.
    Response: We appreciate these comments and will work to ensure that
any guidance provided to SNFs on ICD-10 coding practice aligns with
best practices in this field.
    Comment: A commenter encouraged CMS to ensure that, for SNFs, the
subregulatory process to update ICD-10 mappings and lists aligns with
the process used in the context of the Inpatient Rehabilitation
Facility (IRF) PPS, where the commenter understands providers globally
have accepted the changes.
    Response: We agree and believe the proposed subregulatory update
process for SNFs aligns with the process used in the IRF PPS to update
the tier comorbidities list and the code lists used for the IRF
presumptive compliance methodology. As we noted in the proposed rule,
the subregulatory update process used in the IRF PPS was one of the
models we used to develop the proposed subregulatory process for
updating ICD-10 code mappings and lists in the SNF PDPM.
    Comment: A commenter noted that, in addition to annual
implementation of new and revised ICD-10-CM codes, the conventions and
instructional notes in the ICD-10-CM code set and the ICD-10-CM
Official Guidelines for Coding and Reporting are also updated on
October 1 of each year. The commenter stated that compliance with the
current ICD-10-CM codes, conventions, instructions, and the Official
Guidelines for Coding and Reporting is required for all healthcare
settings under the Health Insurance Portability and Accountability Act
(HIPAA). The commenter recommends that CMS ensure any appropriate
updates to the ICD-10-CM codes associated with PDPM clinical categories
and comorbidity lists that are necessitated by changes to the ICD-10-CM
conventions, instructions, or guidelines are included in the proposed
subregulatory process.
    Response: We agree and will ensure that any appropriate updates to
the ICD-10-CM codes associated with PDPM clinical categories and
comorbidity lists that are necessitated by changes to the ICD-10-CM
conventions, instructions, or guidelines are included in the proposed
subregulatory update process.
    Comment: Some commenters provided specific recommendations on
revisions to the current mappings available on the CMS website, such as
changes in code assignments to clinical categories and the
comorbidities list, additional comorbidities, and other such changes.
    Response: We appreciate the commenters' suggestions for changes in
the current ICD-10 mappings and lists. However, because we consider
these suggestions to be outside the scope of the current rulemaking, we
are not addressing them in this final rule. We will certainly consider
these suggestions as part of our future rulemaking efforts, or for
inclusion in our updated mappings in case certain suggestions may be
characterized as non-substantive in nature.
    After consideration of the comments received, for the reasons
discussed in this final rule and in the FY 2020 SNF PPS proposed rule,
we are finalizing as proposed, without modification, the
[[Page 38753]]
process discussed above for updating the ICD-10 code mappings and lists
associated with PDPM. As proposed, the subregulatory process for
updating the ICD-10 codes used under the PDPM will take effect
beginning with the updates for FY 2020. When the proposed rule was
issued, the ICD-10 code mappings and lists available for download from
the SNF PPS website (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html) reflected the adoption of the ICD-10
Coordination and Maintenance Committee's draft changes to the ICD-10
medical code data sets, effective October 1, 2018, and we stated that
these would constitute the baseline for any future updates to the
mappings and lists using the update process finalized in this rule.
Effective October 1, 2019, these baseline mappings and lists will be
updated to incorporate, as appropriate under the process finalized in
this rule, updates to the ICD-10 code sets issued by the ICD-10
Coordination and Maintenance Committee in June 2019 to be effective
October 1, 2019. We plan to post these updated mappings and lists on
our website prior to October 1, 2019 (and after issuance of this final
rule) so that the public can access them prior to the effective date.
3. Revisions to the Regulations Text
    We proposed to make certain revisions to the regulations text
itself to reflect the revised assessment schedule under the PDPM, as
finalized in the FY 2019 SNF PPS final rule (83 FR 39229).
Specifically, we proposed to revise the prescribed PPS assessment
schedule as set forth in Sec.  413.343(b), to reflect the elimination,
upon the conversion from RUG-IV to PDPM on October 1, 2019, of all
scheduled assessments after the initial 5-day, Medicare-required
assessment. We noted that even though this assessment is commonly
referred to as the ``5-day'' assessment (reflecting its original 5-day
assessment window), an additional 3 grace days have always been
available beyond that window for its actual completion. Further,
because those additional 3 grace days will be directly incorporated
into the assessment window itself effective October 1, 2019 (as
finalized in the FY 2019 SNF PPS final rule (83 FR 39231, 39232, and
39234)), thus resulting in an overall 8-day assessment window, we
additionally proposed to include a conforming revision in Sec.
413.343(b) that we stated was intended to clarify that the deadline for
completing this assessment is no later than the 8th day of posthospital
SNF care. In addition, because under the PDPM, there is only one
scheduled patient assessment, we also proposed to replace the phrase
``patient assessments'' in Sec.  413.343(b) with the phrase ``an
initial patient assessment.'' Accordingly, we proposed to revise Sec.
413.343(b) to state that the assessment schedule must include
performance of an initial patient assessment no later than the 8th day
of posthospital SNF care.
    We further proposed to revise the existing language in Sec.
413.343(b) that additionally requires the completion of ``such other
assessments that are necessary to account for changes in patient care
needs,'' to state ``such other interim payment assessments as the SNF
determines are necessary to account for changes in patient care
needs.'' As we finalized in the FY 2019 SNF PPS final rule (83 FR 39230
through 39234), the optional Interim Payment Assessment (IPA) will
serve as the instrument for conducting assessments under the PDPM that
the SNF determines are necessary after the completion of the 5-day,
Medicare-required assessment to address clinical changes throughout a
SNF stay. We stated that we believe our proposed language is consistent
with the expectation expressed in the FY 2019 SNF PPS final rule for
SNFs ``to provide excellent skilled nursing and rehabilitative care and
continually monitor and document patient status'' (83 FR 39233), and
makes clear that the SNF's responsibility in this context would include
recognizing those situations that warrant a decision to complete an IPA
in order to account appropriately for a change in patient status.
Finally, to ensure consistency, we also proposed to make a conforming
revision to the regulations text in the introductory paragraph of Sec.
409.30, so that it would use the same terminology of ``initial patient
assessment'' as would appear in revised Sec.  413.343(b). Specifically,
in the introductory paragraph of Sec.  409.30, we proposed to replace
the phrase ``the 5-day assessment'' with ``the initial patient
assessment.'' We also noted that the regulations text in the
introductory paragraph of Sec.  409.30 would continue to specify that
the assessment reference date (ARD) for this assessment must occur no
later than the 8th day of posthospital SNF care, consistent with the
instructions set forth in sections 2.8 and 2.9 of the RAI Version 3.0
Manual.
    Commenters submitted the following comments related to the proposed
rule's discussion of the revisions to the regulations text. A
discussion of these comments, along with our responses, appears below.
    Comment: Some commenters expressed concern that the term ``initial
patient assessment'' is somewhat similar to (and, thus, might be
confused with) the interim payment assessment, or IPA, and suggested a
number of other names for the 5-day assessment as possible
alternatives, such as the ``initial Medicare assessment.'' Some
commenters noted confusion over the proposed rule's discussion of this
8-day timeframe (84 FR 17636) as representing the deadline for the
assessment's ``completion.'' Others cited the proposed rule's
discussion of the SNF's responsibility to continually monitor and
document patient status and to recognize those situations that warrant
a decision to complete an IPA in order to account appropriately for a
change in status (84 FR 17636), and requested clarification regarding
how this responsibility comports with the optional nature of the IPA.
One of those commenters characterized the IPA as relating specifically
to resetting the SNF's Part A per diem payment rate and suggested that
the regulations text in proposed Sec.  413.343(b)--which specifies
performing such other IPAs as the SNF determines are necessary ``to
account for changes in patient care needs''--is inappropriate in those
instances where such changes would have no impact on payment. The
commenter recommended deleting that phrase from the regulations text,
noting that a Significant Change in Status Assessment (SCSA) is already
required in those situations that meet the applicable SCSA criteria.
    Response: Although we proposed in the FY 2020 SNF PPS proposed rule
(84 FR 17636) to replace the phrase ``5-day assessment'' with ``initial
patient assessment,'' to help distinguish that assessment more clearly
from the IPA, we will henceforth refer to the 5-day assessment as the
``initial Medicare assessment.'' Further, we wish to resolve any
confusion that the proposed rule's preamble language may have
inadvertently created in referring to the 8th day of posthospital SNF
care as the deadline for ``completing'' this assessment. As explained
in the longstanding instructions in section 2.9 of the RAI Version 3.0
Manual, the initial Medicare assessment itself need not actually be
completed by the 8th day; rather, the assessment reference date (ARD)
for this assessment must be set for a date that is no later than the
8th day of posthospital SNF care (in other words, the facility cannot
designate Day 9 or later as this assessment's ARD). In fact, it is the
parameters for setting the ARD that the existing regulations text at 42
CFR
[[Page 38754]]
413.343(b) has always referenced when requiring a given assessment's
``performance'' in by a specified day. In order to convey that policy
more directly and forestall additional confusion on this point, we are
further revising the proposed regulations text at 42 CFR 413.343(b) to
require the performance of an initial Medicare assessment ``with an
assessment reference date that is set for no later than the 8th day of
posthospital SNF care.'' To ensure consistency, we are also making a
conforming revision in the introductory paragraph of the regulations
text at 42 CFR 409.30, by specifying that the ARD for this assessment
``must be set for'' (rather than ``must occur'') no later than the 8th
day of posthospital SNF care. As specified in section 2.9 of the RAI
Version 3.0 Manual, the actual completion date (Item Z0500B) for this
assessment is ``. . . within 14 days after the ARD (ARD + 14 days).''
Finally, regarding the request for clarification about the optional
nature of the IPA, we note that while an SNF's decision to complete the
IPA itself is indeed optional, the SNF's underlying responsibility to
remain fully aware of (and respond appropriately to) any changes in its
resident's condition is in no way discretionary. Moreover, the
discussion of the IPA in the FY 2019 SNF PPS final rule (83 FR 39233)
clearly envisions a role for this assessment that is not strictly
limited to payment alone: ``We continue to believe that it is necessary
for SNFs to continually monitor the clinical status of each and every
patient in the facility regularly regardless of payment or assessment
requirements and we believe that there should be a mechanism in place
that would allow facilities to do this'' (emphasis added). At the same
time, in making the IPA optional, we recognized ``. . . that providers
may be best situated, as in the case of the Significant Change in
Status Assessment, to determine when a change has occurred that should
be reported through the IPA.'' (84 FR 39233) We believe this discussion
clearly establishes the IPA as one of the vehicles that the SNF can
utilize in the course of carrying out its ongoing patient monitoring
responsibilities. Further, we believe that deleting the longstanding
regulations text regarding changes in patient care needs--which dates
all the way back to the inception of the SNF PPS itself, as originally
issued in the May 12, 1998 SNF PPS interim final rule (63 FR 26311)--
could be misinterpreted as actually precluding SNFs that may wish to
use the IPA in this manner from doing so. Accordingly, we are not
adopting the commenter's recommended revision to Sec.  413.343(b).
    After considering the comments received, for the reasons specified
in this final rule and the FY 2020 SNF PPS proposed rule, we are
finalizing the proposed changes to the regulation text in Sec. Sec.
413.343 and 409.30, with the modifications discussed above.
E. Other Issues
1. Skilled Nursing Facility (SNF) Quality Reporting Program (QRP)
a. Background
    The Skilled Nursing Facility Quality Reporting Program (SNF QRP) is
authorized by section 1888(e)(6) of the Act and it applies to
freestanding SNFs, SNFs affiliated with acute care facilities, and all
non-CAH swing-bed rural hospitals. Under the SNF QRP, the Secretary
must reduce by 2 percentage points the annual market basket percentage
update described in section 1888(e)(5)(B)(i) of the Act applicable to a
SNF for a fiscal year, after application of section 1888(e)(5)(B)(ii)
of the Act (the MFP adjustment) and section 1888(e)(5)(B)(iii) of the
Act, in the case of a SNF that does not submit data in accordance with
sections 1888(e)(6)(B)(i) of the Act for that fiscal year. For more
information on the requirements we have adopted for the SNF QRP, we
refer readers to the FY 2016 SNF PPS final rule (80 FR 46427 through
46429), FY 2017 SNF PPS final rule (81 FR 52009 through 52010), FY 2018
SNF PPS final rule (82 FR 36566), and FY 2019 SNF PPS final rule (83 FR
39162 through 39272).
b. General Considerations Used for the Selection of Measures for the
SNF QRP
    For a detailed discussion of the considerations we use for the
selection of SNF QRP quality, resource use, and other measures, we
refer readers to the FY 2016 SNF PPS final rule (80 FR 46429 through
46431).
    Comment: Several commenters expressed general support for CMS'
proposed changes to the SNF QRP. One commenter expressed general
support of CMS efforts to improve the Quality Reporting Program while
another commenter recognized that the changes are part of a multi-year
process to reform patient assessment and quality reporting across
multiple levels of care. Another commenter expressed appreciation for
CMS transparency and responsiveness to stakeholder input during the
development and testing of the proposed SNF QRP measures, measure
refinement, and proposed Standardized Patient Assessment Data Elements
(SPADEs) which they believe are much improved from earlier draft
versions and reflect many of the concerns and recommendations we have
previously offered. One commenter was concerned about specialty
populations and suggested that CMS make appropriate modifications to
the application of the QRP to special populations programs and via
distinct reimbursement to state-recognized special populations programs
to avoid unintended consequences for specialty populations such as
those living with HIV/AIDS.
    Response: We thank the commenters for their support and
suggestions. While we consider general comments regarding specialty
populations to be out of the scope of this final rule, we will take
into consideration the impact of specialty populations in our future
work.
c. Quality Measures Currently Adopted for the FY 2021 SNF QRP
    The SNF QRP currently has 11 measures for the FY 2021 SNF QRP,
which are set out in Table 12.
[[Page 38755]]
  Table 12--Quality Measures Currently Adopted for the FY 2021 SNF QRP
------------------------------------------------------------------------
          Short name                   Measure name & data source
------------------------------------------------------------------------
             Resident Assessment Instrument Minimum Data Set
------------------------------------------------------------------------
Pressure Ulcer/Injury........  Changes in Skin Integrity Post-Acute
                                Care: Pressure Ulcer/Injury.
Application of Falls.........  Application of Percent of Residents
                                Experiencing One or More Falls with
                                Major Injury (Long Stay) (NQF #0674).
Application of Functional      Application of Percent of Long-Term Care
 Assessment/Care Plan.          Hospital (LTCH) Patients with an
                                Admission and Discharge Functional
                                Assessment and a Care Plan That
                                Addresses Function (NQF #2631).
Change in Mobility Score.....  Application of IRF Functional Outcome
                                Measure: Change in Mobility Score for
                                Medical Rehabilitation Patients (NQF
                                #2634).
Discharge Mobility Score.....  Application of IRF Functional Outcome
                                Measure: Discharge Mobility Score for
                                Medical Rehabilitation Patients (NQF
                                #2636).
Change in Self-Care Score....  Application of the IRF Functional Outcome
                                Measure: Change in Self-Care Score for
                                Medical Rehabilitation Patients (NQF
                                #2633).
Discharge Self-Care Score....  Application of IRF Functional Outcome
                                Measure: Discharge Self-Care Score for
                                Medical Rehabilitation Patients (NQF
                                #2635).
DRR..........................  Drug Regimen Review Conducted With Follow-
                                Up for Identified Issues-Post Acute Care
                                (PAC) Skilled Nursing Facility (SNF)
                                Quality Reporting Program (QRP).
------------------------------------------------------------------------
                              Claims-Based
------------------------------------------------------------------------
MSPB SNF.....................  Medicare Spending Per Beneficiary (MSPB)--
                                Post Acute Care (PAC) Skilled Nursing
                                Facility (SNF) Quality Reporting Program
                                (QRP).
DTC..........................  Discharge to Community (DTC)--Post Acute
                                Care (PAC) Skilled Nursing Facility
                                (SNF) Quality Reporting Program (QRP).
PPR..........................  Potentially Preventable 30-Day Post--
                                Discharge Readmission Measure for
                                Skilled Nursing Facility (SNF) Quality
                                Reporting Program (QRP).
------------------------------------------------------------------------
    While we did not solicit comments on currently adopted measures
(with the exception of the Discharge to Community Measure discussed in
section III.E.1.d.(3) of this rule and the policies regarding public
display of Drug Regimen Review Conducted With Follow-Up for Identified
Issues-Post Acute Care (PAC) Skilled Nursing Facility (SNF) Quality
Reporting Program (QRP) measure data in section III.E.1.i. of this
rule), we received several comments.
    Comments: One commenter expressed concerns with the Drug Regimen
Review Conducted With Follow-Up for Identified Issues--Post Acute Care
(PAC) Skilled Nursing Facility (SNF) Quality Reporting Program (QRP)
measure, believing that the measure does not identify where clinically
significant recommendations originate, there is no measure of what is
considered ``good'' when comparing rates at different facilities, and
that facilities that place a high value on regular drug regimen review
conducted by a consultant pharmacist deserve to be recognized for their
efforts to improve patient safety and adherence to medication regimens.
Another commenter does not support the Application of Percent of Long-
Term Care Hospital (LTCH) Patients with an Admission and Discharge
Functional Assessment and a Care Plan That Addresses Function (NQF
#2631) measure, preferring outcome-based measures based on measures
currently used in Nursing Home Compare. The commenter suggested a
number of alternative measures for interim use in the SNF QRP until
more measures are developed. This commenter also expressed concerns
with the use of the four functional outcome measures in the SNF QRP
encouraging CMS to identify a timeline for NQF endorsement. One
commenter recommended that CMS adopt a standard process for evaluating
whether a measure should be retained in the SNF QRP or removed or
retired from the SNF QRP.
    Response: We appreciate the comments on our implemented measures,
the Drug Regimen Review Conducted With Follow-Up for Identified
Issues--Post Acute Care (PAC) Skilled Nursing Facility (SNF) Quality
Reporting Program (QRP) and the Application of Percent of Long-Term
Care Hospital (LTCH) Patients with an Admission and Discharge
Functional Assessment and a Care Plan That Addresses Function (NQF
#2631) and note that we did not propose changes to these measures, so
comments are outside the scope of this rule. In Table 12, we have
provided a list of measures that are currently adopted in the SNF QRP.
For the eight factors used to evaluate whether a measure should be
removed from the SNF QRP, we refer readers to Sec.  413.360(b)(3) of
our regulations.
d. Adoption of Two New Quality Measures and Updated Specifications for
a Third Quality Measure Beginning With the FY 2022 SNF QRP
    In the FY 2020 SNF PPS proposed rule (84 FR 17637 through 17643),
we proposed to adopt two process measures for the SNF QRP that, as
required by section 1888(e)(6)(B)(i)(II) of the Act, would satisfy
section 1899B(c)(1)(E)(ii) of the Act, which requires that the quality
measures specified by the Secretary include measures with respect to
the quality measure domain titled ``Accurately communicating the
existence of and providing for the transfer of health information and
care preferences of an individual to the individual, family caregiver
of the individual, and providers of services furnishing items and
services to the individual when the individual transitions from a post-
acute care (PAC) provider to another applicable setting, including a
different PAC provider, a hospital, a critical access hospital, or the
home of the individual.'' Given the length of this domain title,
hereafter, we will refer to this quality measure domain as ``Transfer
of Health Information.''
    The two measures we proposed to adopt were: (1) Transfer of Health
Information to the Provider--Post-Acute Care (PAC); and (2) Transfer of
Health Information to the Patient--Post-Acute Care (PAC). Both of these
proposed measures support our Meaningful Measures priority of promoting
effective communication and coordination of care, specifically the
Meaningful Measure area of the transfer of health information and
interoperability.
    In addition to the two measure proposals, we proposed to update the
specifications for the Discharge to Community--PAC SNF QRP measure to
exclude baseline nursing facility (NF) residents from the measure.
IV. (1) Transfer of Health Information to the Provider--Post-Acute Care
(PAC) Measure
    The Transfer of Health Information to the Provider--Post-Acute Care
(PAC) Measure that we proposed to adopt beginning with the FY2022 SNF
QRP is a process-based measure that assesses whether or not a current
reconciled medication list is given to the subsequent provider when a
patient is discharged or transferred from his or her current PAC
setting.
(a) Background
    In 2013, 22.3 percent of all acute hospital discharges were
discharged to PAC settings, including 11 percent who were discharged to
home under the care of a home health agency, and nine
[[Page 38756]]
percent who were discharged to SNFs.\1\ The proportion of patients
being discharged from an acute care hospital to a PAC setting was
greater among beneficiaries enrolled in Medicare fee-for-service (FFS).
Among Medicare FFS patients discharged from an acute hospital, 42
percent went directly to PAC settings. Of that 42 percent, 20 percent
were discharged to a SNF, 18 percent were discharged to a home health
agency (HHA), 3 percent were discharged to an IRF, and 1 percent were
discharged to an LTCH.\2\ Of the Medicare FFS beneficiaries with a SNF
stay in FY 2017, an estimated 21 percent were discharged or transferred
to an acute care hospital, 11 percent discharged home with home health
services, and two percent discharged or transferred to another PAC
setting (for example, an IRF, a hospice, or another SNF).\3\
---------------------------------------------------------------------------
    \1\ Tian, W. ``An all-payer view of hospital discharge to post-
acute care,'' May 2016. Available at https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
    \2\ Ibid.
    \3\ RTI International analysis of Medicare claims data for index
stays in SNF 2017. (RTI program reference: IB55).
---------------------------------------------------------------------------
    The transfer and/or exchange of health information from one
provider to another can be done verbally (for example, clinician-to-
clinician communication in-person or by telephone), paper-based (for
example, faxed or printed copies of records), and via electronic
communication (for example, through a health information exchange
network using an electronic health/medical record, and/or secure
messaging). Health information, such as medication information, that is
incomplete or missing increases the likelihood of a patient or resident
safety risk, and is often life-threatening.4 5 6 7 8 9 Poor
communication and coordination across health care settings contributes
to patient complications, hospital readmissions, emergency department
visits, and medication errors.10 11 12 13 14 15 16 17 18 19
Communication has been cited as the third most frequent root cause in
sentinel events, which The Joint Commission \20\ defines as a patient
safety event that results in death, permanent harm, or severe temporary
harm. Failed or ineffective patient handoffs are estimated to play a
role in 20 percent of serious preventable adverse events.\21\ When care
transitions are enhanced through care coordination activities,  such as
expedited patient information flow, these activities can reduce
duplication of care services and costs of care, resolve conflicting
care plans, and prevent medical errors.22 23 24 25 26
---------------------------------------------------------------------------
    \4\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
    \5\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
    \6\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \7\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
    \8\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
    \9\ Boling, P.A., ``Care transitions and home health care,''
Clinical Geriatric Medicine, 2009, Vol.25(1), pp. 135-48.
    \10\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of
medication information across settings--keeping it free from
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
    \11\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
    \12\ Jencks, S.F., Williams, M.V., & Coleman, E.A.,
``Rehospitalizations among patients in the Medicare fee-for-service
program,'' New England Journal of Medicine, 2009, Vol. 360(14), pp.
1418-1428.
    \13\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at https://www.nap.edu/read/11623/chapter/1.
    \14\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling approach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
    \15\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \16\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at https://www.nap.edu/read/11623/chapter/1.
    \17\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling approach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
    \18\ Forster, A.J., Murff, H.J., Peterson, J.F., Gandhi, T.K., &
Bates, D.W., ``The incidence and severity of adverse events
affecting patients after discharge from the hospital.'' Annals of
Internal Medicine, 2003,138(3), pp. 161-167.
    \19\ King, B.J., Gilmore[hyphen]Bykovskyi, A.L., Roiland, R.A.,
Polnaszek, B.E., Bowers, B.J., & Kind, A.J. ``The consequences of
poor communication during transitions from hospital to skilled
nursing facility: a qualitative study,'' Journal of the American
Geriatrics Society, 2013, Vol. 61(7), 1095-1102.
    \20\ The Joint Commission, ``Sentinel Event Policy'' available
at https://www.jointcommission.org/sentinel_event_policy_and_procedures/.
    \21\ The Joint Commission. ``Sentinel Event Data Root Causes by
Event Type 2004 -2015.'' 2016. Available at https://www.jointcommission.org/assets/1/23/jconline_Mar_2_2016.pdf.
    \22\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \23\ Institute of Medicine, ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies
Press, 2007. Available at https://www.nap.edu/read/11623/chapter/1.
    \24\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C.,
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner,
A.J., Harper, M.B., & Landrigan, C. P., ``Rates of medical errors
and preventable adverse events among hospitalized children following
implementation of a resident handoff bundle,'' JAMA, 2013, Vol.
310(21), pp. 2262-2270.
    \25\ Pronovost, P., M.M.E. Johns, S. Palmer, R.C. Bono, D.B.
Fridsma, A. Gettinger, J. Goldman, W. Johnson, M. Karney, C. Samitt,
R.D. Sriram, A. Zenooz, and Y.C. Wang, Editors. Procuring
Interoperability: Achieving High-Quality, Connected, and Person-
Centered Care. Washington, DC, 2018. National Academy of Medicine.
Available at https://nam.edu/wp-content/uploads/2018/10/Procuring-Interoperability_web.pdf.
    \26\ Balaban RB, Weissman JS, Samuel PA, & Woolhandler, S.,
``Redefining and redesigning hospital discharge to enhance patient
care: a randomized controlled study,'' J Gen Intern Med, 2008, Vol.
23(8), pp. 1228-33.
    \27\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S. F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol 29(6), pp. 932-939.
    \28\ Simmons, S., Schnelle, J., Slagle, J., Sathe, N.A.,
Stevenson, D., Carlo, M., & McPheeters, M.L., ``Resident safety
practices in nursing home settings.'' Technical Brief No. 24
(Prepared by the Vanderbilt Evidence-based Practice Center under
Contract No. 290-2015-00003-I.) AHRQ Publication No. 16-EHC022-EF.
Rockville, MD: Agency for Healthcare Research and Quality. May 2016.
Available at https://www.ncbi.nlm.nih.gov/books/NBK384624/.
---------------------------------------------------------------------------
    Care transitions across health care settings have been
characterized as complex, costly, and potentially hazardous, and may
increase the risk for multiple adverse outcomes.27 28 The
rising incidence of preventable adverse events, complications, and
hospital readmissions have drawn attention to the importance of the
timely transfer of health information and care preferences at the time
of transition. Failures of care coordination, including poor
communication of information, were estimated to cost the U.S. health
care system between $25 billion and $45 billion in wasteful spending in
2011.\29\ The communication of health information and patient care
preferences is critical to ensuring safe and effective
[[Page 38757]]
transitions from one health care setting to another.30 31
---------------------------------------------------------------------------
    \29\ Berwick, D.M. & Hackbarth, A.D. ``Eliminating Waste in US
Health Care,'' JAMA, 2012, Vol. 307(14), pp.1513-1516.
    \30\ McDonald, K.M., Sundaram, V., Bravata, D.M., Lewis, R.,
Lin, N., Kraft, S.A. & Owens, D.K. Care Coordination. Vol. 7 of:
Shojania K.G., McDonald K.M., Wachter R.M., Owens D.K., editors.
``Closing the quality gap: A critical analysis of quality
improvement strategies.'' Technical Review 9 (Prepared by the
Stanford University-UCSF Evidence-based Practice Center under
contract 290-02-0017). AHRQ Publication No. 04(07)-0051-7.
Rockville, MD: Agency for Healthcare Research and Quality. June
2006. Available at https://www.ncbi.nlm.nih.gov/books/NBK44015/.
    \31\ Lattimer, C., ``When it comes to transitions in patient
care, effective communication can make all the difference,''
Generations, 2011, Vol. 35(1), pp. 69-72.
---------------------------------------------------------------------------
    Patients in PAC settings often have complicated medication regimens
and require efficient and effective communication and coordination of
care between settings, including detailed transfer of medication
information.32 33 34 Individuals in PAC settings may be
vulnerable to adverse health outcomes due to insufficient medication
information on the part of their health care providers, and the higher
likelihood for multiple comorbid chronic conditions, polypharmacy, and
complicated transitions between care settings.35 36
Preventable adverse drug events (ADEs) may occur after hospital
discharge in a variety of settings including PAC.\37\ A 2014 Office of
Inspector General report found that almost one-tenth of Medicare
beneficiaries experienced an ADE, such as delirium, bleeding, fall or
injury, or constipation, during their stay in a SNF in 2011. Of these,
two-thirds were classified as preventable.\38\ Medication errors and
one-fifth of ADEs occur during transitions between settings, including
admission to or discharge from a hospital to home or a PAC setting, or
transfer between hospitals.39 40
---------------------------------------------------------------------------
    \32\ Starmer A.J, Spector N.D., Srivastava R., West, D.C.,
Rosenbluth, G., Allen, A.D., Noble, E.L., & Landrigen, C.P.,
``Changes in medical errors after implementation of a handoff
program,'' N Engl J Med, 2014, Vol. 37(1), pp. 1803-1812.
    \33\ Kruse, C.S. Marquez, G., Nelson, D., & Polomares, O., ``The
use of health information exchange to augment patient handoff in
long-term care: a systematic review,'' Applied Clinical Informatics,
2018, Vol. 9(4), pp. 752-771.
    \34\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R., ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
    \35\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation
during the transition to and from long-term care settings: a
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
    \36\ Levinson, D.R., & General, I., ``Adverse events in skilled
nursing facilities: national incidence among Medicare
beneficiaries.'' Washington, DC: U.S. Department of Health and Human
Services, Office of Inspector General, February 2014. Available at
https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
    \37\ Battles J., Azam I., Grady M., & Reback K., ``Advances in
patient safety and medical liability,'' AHRQ Publication No. 17-
0017-EF. Rockville, MD: Agency for Healthcare Research and Quality,
August 2017. Available at https://www.ahrq.gov/sites/default/files/publications/files/advances-complete_3.pdf.
    \38\ Health and Human Services Office of Inspector General.
Adverse events in skilled nursing facilities: National incidence
among Medicare beneficiaries. OEI-06-11-00370). 2014. Available at
https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
    \39\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of
medication information across settings--keeping it free from
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
    \40\ Gleason, K.M., Groszek, J.M., Sullivan, C., Rooney, D.,
Barnard, C., Noskin, G.A., ``Reconciliation of discrepancies in
medication histories and admission orders of newly hospitalized
patients,'' American Journal of Health System Pharmacy, 2004, Vol.
61(16), pp. 1689-1694.
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    Patients in PAC settings are often taking multiple medications.
Consequently, PAC providers regularly are in the position of starting
complex new medication regimens with little knowledge of the patients
or their medication history upon admission. Furthermore, inter-facility
communication barriers delay resolving medication discrepancies during
transitions of care.\41\ Medication discrepancies are common,\42\ and
found to occur in 86 percent of all transitions, increasing the
likelihood of ADEs.43 44 45 Up to 90 percent of patients
experience at least one medication discrepancy in the transition from
hospital to home care, and discrepancies occur within all therapeutic
classes of medications.46 47
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    \41\ Patterson M., Foust J.B., Bollinger, S., Coleman, C.,
Nguyen, D., ``Inter-facility communication barriers delay resolving
medication discrepancies during transitions of care,'' Research in
Social & Administrative Pharmacy (2018), doi: 10.1016/
j.sapharm.2018.05.124.
    \42\ Manias, E., Annaikis, N., Considine, J., Weerasuriya, R., &
Kusljic, S. ``Patient-, medication- and environment-related factors
affecting medication discrepancies in older patients,'' Collegian,
2017, Vol. 24, pp. 571-577.
    \43\ Tjia, J., Bonner, A., Briesacher, B.A., McGee, S., Terrill,
E., Miller, K., ``Medication discrepancies upon hospital to skilled
nursing facility transitions,'' J Gen Intern Med, 2009, Vol. 24(5),
pp. 630-635.
    \44\ Sinvani, L.D., Beizer, J., Akerman, M., Pekmezaris, R.,
Nouryan, C., Lutsky, L., Cal, C., Dlugacz, Y., Masick, K., Wolf-
Klein, G.,'' Medication reconciliation in continuum of care
transitions: a moving target,'' J Am Med Dir Assoc, 2013, Vol.
14(9), 668-672.
    \45\ Coleman E.A., Parry C., Chalmers S., & Min, S.J., ``The
Care Transitions Intervention: results of a randomized controlled
trial,'' Arch Intern Med, 2006, Vol. 166, pp. 1822-1828.
    \46\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, L.D.,
``Nurse identified hospital to home medication discrepancies:
implications for improving transitional care,'' Geriatr Nurs, 2011,
Vol. 31(3), pp. 188-196.
    \47\ Setter S.M., Corbett C.F., Neumiller J.J., Gates, B.J.,
Sclar, D.A., & Sonnett, T.E., ``Effectiveness of a pharmacist-nurse
intervention on resolving medication discrepancies in older patients
transitioning from hospital to home care: impact of a pharmacy/
nursing intervention,'' Am J Health Syst Pharm, 2009, Vol. 66, pp.
2027-2031.
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    Transfer of a medication list between providers is necessary for
medication reconciliation interventions, which have been shown to be a
cost-effective way to avoid ADEs by reducing errors,48 49 50
especially when medications are reviewed by a pharmacist using
electronic medical records.\51\
---------------------------------------------------------------------------
    \48\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
    \49\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
    \50\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation
during the transition to and from long-term care settings: a
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
    \51\ Agrawal A, Wu WY. ``Reducing medication errors and
improving systems reliability using an electronic medication
reconciliation system,'' The Joint Commission Journal on Quality and
Patient Safety, 2009, Vol. 35(2), pp. 106-114.
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(b) Stakeholder and Technical Expert Panel (TEP) Input
    The proposed measure was developed after consideration of feedback
we received from stakeholders and four TEPs convened by our
contractors. Further, the proposed measure was developed after
evaluation of data collected during two pilot tests we conducted in
accordance with the CMS Measures Management System Blueprint.
    Our measure development contractors constituted a TEP which met on
September 27, 2016,\52\ January 27,
[[Page 38758]]
2017,\53\ and August 3, 2017 \54\ to provide input on a prior version
of this measure. Based on this input, we updated the measure concept in
late 2017 to include the transfer of a specific component of health
information--medication information. Our measure development
contractors reconvened this TEP on April 20, 2018 for the purpose of
obtaining expert input on the proposed measure, including the measure's
reliability, components of face validity, and feasibility of being
implemented across PAC settings. Overall, the TEP was supportive of the
proposed measure, affirming that the measure provides an opportunity to
improve the transfer of medication information. A summary of the April
20, 2018 TEP proceedings titled ``Transfer of Health Information TEP
Meeting 4-June 2018'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
    \52\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
    \53\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
    \54\ Ibid.
---------------------------------------------------------------------------
    Our measure development contractors solicited stakeholder feedback
on the proposed measure by requesting comment on the CMS Measures
Management System Blueprint website, and accepted comments that were
submitted from March 19, 2018 to May 3, 2018. The comments received
expressed overall support for the measure. Several commenters suggested
ways to improve the measure, primarily related to what types of
information should be included at transfer. We incorporated this input
into development of the proposed measure. The summary report for the
March 19 to May 3, 2018 public comment period titled ``IMPACT
Medication-Profile-Transferred-Public-Comment-Summary-Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(c) Pilot Testing
    The proposed measure was tested between June and August 2018 in a
pilot test that involved 24 PAC facilities/agencies, including five
IRFs, six SNFs, six LTCHs, and seven HHAs. The 24 pilot sites submitted
a total of 801 records. Analysis of agreement between coders within
each participating facility (266 qualifying pairs) indicated a 93-
percent agreement for this measure. Overall, pilot testing enabled us
to verify its reliability, components of face validity, and feasibility
of being implemented across PAC settings. Further, more than half of
the sites that participated in the pilot test stated during the
debriefing interviews that the measure could distinguish facilities or
agencies with higher quality medication information transfer from those
with lower quality medication information transfer at discharge. The
pilot test summary report titled ``Transfer of Health Information 2018
Pilot Test Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(d) Measure Applications Partnership (MAP) Review and Related Measures
    We included the proposed measure in the SNF QRP section of the 2018
Measures Under Consideration (MUC) List. The MAP conditionally
supported this measure pending NQF endorsement, noting that the measure
can promote the transfer of important medication information. The MAP
also suggested that CMS consider a measure that can be adapted to
capture bi-directional information exchange, and recommended that the
medication information transferred include important information about
supplements and opioids. More information about the MAP's
recommendations for this measure is available at http://www.qualityforum.org/Publications/2019/02/MAP_2019_Considerations_for_Implementing_Measures_Final_Report_-_PAC-LTC.aspx.
    As part of the measure development and selection process, we also
identified one NQF-endorsed quality measure similar to the proposed
measure, titled Documentation of Current Medications in the Medical
Record (NQF #0419, CMS eCQM ID: CMS68v8). This measure was adopted as
one of the recommended adult core clinical quality measures for
eligible professionals for the EHR Incentive Program beginning in 2014,
and was also adopted under the Merit-based Incentive Payment System
(MIPS) quality performance category beginning in 2017. The measure is
calculated based on the percentage of visits for patients aged 18 years
and older for which the eligible professional or eligible clinician
attests to documenting a list of current medications using all
resources immediately available on the date of the encounter.
    The proposed Transfer of Health Information to the Provider--Post-
Acute Care (PAC) measure addresses the transfer of information whereas
the NQF-endorsed measure #0419 assesses the documentation of
medications, but not the transfer of such information. This is
important as the proposed measure assesses for the transfer of
medication information for the proposed measure calculation. Further,
the proposed measure utilizes standardized patient assessment data
elements (SPADEs), which is a requirement for measures specified under
the Transfer of Health Information measure domain under section
1899B(c)(1)(E) of the Act, whereas NQF #0419 does not.
    After review of the NQF-endorsed measure, we determined that the
proposed Transfer of Health Information to the Provider--Post-Acute
Care (PAC) measure better addresses the Transfer of Health Information
measure domain, which requires that at least some of the data used to
calculate the measure be collected as standardized patient assessment
data through the post-acute care assessment instruments. Section
1899B(e)(2)(A) of the Act requires that any measure specified by the
Secretary be endorsed by the entity with a contract under section
1890(a) of the Act, which is currently the National Quality Form (NQF).
However, when a feasible and practical measure has not been NQF
endorsed for a specified area or medical topic determined appropriate
by the Secretary, section 1899B(e)(2)(B) of the Act allows the
Secretary to specify a measure that is not NQF endorsed as long as due
consideration is given to the measures that have been endorsed or
adopted by a consensus organization identified by the Secretary. For
the reasons discussed previously, we believe that there is currently no
feasible NQF-endorsed measure that we could adopt under section
1899B(c)(1)(E) of the Act. However, we note that we intend to submit
the proposed measure to the NQF for consideration of endorsement when
feasible.
[[Page 38759]]
(e) Quality Measure Calculation
    The proposed Transfer of Health Information to the Provider--Post-
Acute Care (PAC) quality measure is calculated as the proportion of
resident stays with a discharge assessment indicating that a current
reconciled medication list was provided to the subsequent provider at
the time of discharge. The proposed measure denominator is the total
number of SNF resident stays, ending in discharge to a ``subsequent
provider,'' which is defined as a short-term general acute-care
hospital, a skilled nursing facility (SNF), intermediate care
(intellectual and developmental disabilities providers), home under
care of an organized home health service organization or hospice,
hospice in an institutional facility, an inpatient rehabilitation
facility (IRF), an LTCH, a Medicaid nursing facility, an inpatient
psychiatric facility, or a critical access hospital (CAH). These health
care providers were selected for inclusion in the denominator because
they are identified as subsequent providers on the discharge
destination item that is currently included on the resident assessment
instrument minimum data set (MDS), the current version being MDS 3.0.
The proposed measure numerator is the number of SNF resident stays with
an MDS discharge assessment indicating a current reconciled medication
list was provided to the subsequent provider at the time of discharge.
For additional technical information about this proposed measure, we
refer readers to the document titled, ``Final Specifications for SNF
QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The data source for the proposed quality measure is the MDS assessment
instrument for SNF residents.
    For more information about the data submission requirements we
proposed for this measure, we refer readers to section III.E.1.h.(3) of
this final rule.
    Commenters submitted the following comments related to the proposed
rule's discussion of the SNF QRP Quality Measure Proposals beginning
with the FY 2022 SNF QRP. A discussion of these comments, along with
our responses, appears below. We also address comments on the proposed
Transfer of Health Information to the Patient--Post-Acute Care measure
(discussed further in a subsequent section of this final rule) in this
section because commenters frequently addressed both Transfer of Health
Information measures together.
    Comment: The majority of commenters supported the adoption of both
of the Transfer of Health Information measures. These commenters stated
that the measures will help improve care coordination, patient safety,
and care transitions.
    Response: We thank commenters for their support of the Transfer of
Health Information measures.
    Comment: One commenter suggested that other providers, such as
outpatient physical therapists, should be included in the definition of
a subsequent provider for the Transfer of Health Information to the
Provider--Post-Acute Care measure.
    Response: We appreciate the suggestion to expand the Transfer of
Health Information to the Provider--Post-Acute Care measure outcome to
assess the transfer of health information to other providers such as
outpatient physical therapists. We recognize that sharing medication
information with outpatient providers is important, and will take into
consideration additional providers in future measure modifications.
Through our measure development and pilot testing we learned that
outpatient providers cannot always be readily identified by the PAC
provider. For this process measure, which serves as a building block
for improving the transfer of medication information, we specified
providers who will be involved in the care of the patient and
medication management after discharge and can be readily identified
through the discharge location item on the MDS. The clear delineation
of the recipient of the medication list in the measure specifications
will improve measure reliability and validity.
    Comment: One commenter recommended that the Transfer of Health
Information to the Provider--Post-Acute Care measure be expanded to
include the transfer of information that would help prevent infections
and facilitate appropriate infection prevention and control
interventions during care transitions in addition to the medication
information in the finalized measures.
    Response: The Transfer of Health Information to the Provider--Post-
Acute Care measure focuses on the transfer of a reconciled medication
list. The measure was designed after input from TEPs, public comment,
and other stakeholders that suggested the quality measures focus on the
transfer of the most critical pieces of information to support patient
safety and care coordination. However, we acknowledge that the transfer
of many other forms of health information is important, and while the
focus of this measure is on a reconciled medication list, we hope to
expand our measures in the future.
    Comment: Some commenters raised concerns about both of the Transfer
of Health Information measures not being endorsed by the National
Quality Forum (NQF). Some commenters recommended that CMS receive NQF
approval before adoption.
    Response: We agree that the NQF endorsement process is an important
part of measure development. As discussed in the FY 2020 SNF PPS
proposed rule (84 FR 17639 through 17640), we believe that the measures
better address the Transfer of Health Information measure domain, which
requires that at least some of the data used to calculate the measure
be collected as standardized patient assessment data through the post-
acute care assessment instruments, than any endorsed measures. While
section 1899B(e)(2)(A) of the Act requires that any measure specified
by the Secretary be endorsed by the entity with a contract under
section 1890(a) of the Act, which is currently the National Quality
Form (NQF), when a feasible and practical measure has not been NQF
endorsed for a specified area or medical topic determined appropriate
by the Secretary, section 1899B(e)(2)(B) of the Act allows the
Secretary to specify a measure that is not NQF endorsed as long as due
consideration is given to the measures that have been endorsed or
adopted by a consensus organization identified by the Secretary. We
plan to submit the measure for NQF endorsement consideration as soon as
feasible.
    Comment: Several commenters believe that the Transfer of Health
Information to the Provider and Transfer of Health Information to the
Patient measures will add burden. One commenter stated that both
measures will add burden with no added value and did not support the
measures for that reason. Another commenter noted that there will be
additional burden to collect and report data for these two measures in
part because most PAC providers do not have access to EHRs or health
information technology systems that facilitate their ability to
electronically share this information.
    Response: We are very mindful of burden that may occur from the
collection and reporting of these measures, as supported by the CMS
[[Page 38760]]
Meaningful Measures and Patients over Paperwork initiatives. The timely
and complete transfer of information focuses on the medication list, as
suggested by our TEP, public comment, and SMEs. We would like to
emphasize that both measures are comprised of one item only, and
further, the activities associated with the measures align with
existing requirements related to transferring information at the time
of a discharge in order to safeguard patients. Additionally, TEP
feedback and pilot test found that burden of reporting will not be
significant. We believe that these measures will likely drive
improvements in the transfer of medication information between
providers and with patients, families, and caregivers.
    Comment: A commenter stated there will be no additional data
collection time or overall burden to SNFs as the Transfer of Health
Information measures will use data already captured in the MDS.
    Response: We agree that the Transfer of Health Information measures
will not add additional burden in data collection over time as the data
captured by these measures aligns with the standards of care for the
discharge or transfer of a SNF resident and are a part of common
practice.
    Comment: In comments related to both Transfer of Health Information
measures, some commenters raised concerns about documenting the
transfer of a medication list in the event of an audit, noting that
providers are simply required to attest to the transfer process taking
place. One commenter stated that there are many ways to operationalize
and document this process in the medical record; however, CMS has not
indicated whether it would favor certain methods over others. A few
commenters also noted that the form of the current reconciled
medication list is not specified, nor is the method or route that the
medication list is provided (that is, verbal, paper copy), which
presents its own documentation challenges in ensuring adequate
supporting evidence is available in the event of an audit. For these
reasons, some commenters requested that CMS provide additional clarity
regarding its documentation expectations and to consider the least
burdensome ways for providers to comply while meeting the needs of a
potential audit. One commenter also questioned whether the Transfer of
Health Information to the Provider and Transfer of Health Information
to the Patient measures require that the facility prove receipt of the
transferred information by the other provider or patient. Lastly,
another commenter questioned if there are any potential penalties
related to documentation that may be associated with the measures as
part of QRP program.
    Response: Both measures simply require a SNF to document that the
transfer of medication information took place. The Transfer of Health
Information measures serve as a check to ensure that a reconciled
medication list is provided as the patient changes care settings. We
would like to note that it is up to the provider to decide if they have
transferred a medication list that may include the following
information: Known medication and other allergies, known drug
sensitivities and reactions; each medication, including the name,
strength, dose, route of medication administration, and/or the reason
for holding a medication or when a medication should resume. Defining
the completeness of that medication list is left to the discretion of
the providers and patient who are coordinating this care. We interpret
the comments on audits to be referring to data validation. While we do
not have a data validation program in place at this time, we are
exploring such a program akin to that of the hospital inpatient quality
reporting program. For all measures and data collected for the SNF QRP,
we monitor and evaluate our data to assess for coding patterns, errors,
reliability, and soundness of the data. Through data monitoring, we are
able to assess if measure outcomes are consistent with the information
that is collected.
    With respect to the comment asking about whether there are any
penalties associated with the proposed Transfer of Health Information
measures, our policy for the SNF QRP is that, as detailed in 42 CFR
413.360(b)(2), SNFs must submit 100 percent of the required data
elements on at least 80 percent of the MDS assessments submitted to be
in compliance with SNF QRP requirements for a program year. SNFs are
penalized if they do not meet this threshold.
    Comment: In comments related to both Transfer of Health Information
measures, some commenters commented on requiring hospitals to provide
SNFs with important information at discharge. One commenter recommended
that the Transfer of Health Information Measures be applied to acute
care hospitals to ensure two-way, or bi-directional transfer of
information and to support interoperability. A few commenters
encouraged CMS to finalize revisions to ``Requirements for Discharge
Planning for Hospitals, Critical Access Hospitals, and Home Health
Agencies'' (CMS-3317-P), which would require hospitals to transfer
patient information, including diagnosis and other clinical
information, to the patient's next setting in a timely manner.
    Response: We agree that the bi-directional transfer of health
information between hospitals and PAC providers is important and will
support efforts to improve interoperability.
    Further, we believe that these measures will bring greater
attention to the importance of the transfer of health information
across all settings, increasing the seamless exchange of information
across the care continuum. The Revisions to Requirements for Discharge
Planning for Hospitals, Critical Access Hospitals, and Home Health
Agencies proposed rule (CMS-3317-P) has not been finalized. CMS has
issued an extension notice for the publication of the final rule, which
extends the timeline for publication of the final rule until November
3, 2019 (please see (https://www.federalregister.gov/documents/2018/11/02/2018-23922/medicare-and-medicaid-programs-revisions-to-requirements-for-discharge-planning-for-hospitals).
    Comment: A few commenters noted concerns that the Transfer of
Health Information to the Provider and Transfer of Health Information
to the Patient measures are not indicative of provider quality and
questioned the ability of the measures to improve patient outcomes. One
commenter did not support the measures for this reason. One commenter
noted that the measures assess whether a medication list was
transferred and not whether that medication list was accurate and
received by the subsequent provider.
    Response: The Transfer of Health Information to the Provider-Post-
Acute Care and Transfer of Health Information to the Patient-Post-Acute
Care measures are process measures designed to address and improve an
important aspect of care quality. Lack of timely transfer of medication
information at transitions has been demonstrated to lead to increased
risk of adverse events, medication errors, and hospitalizations.
Because this measure would encourage the transfer of medication
information, it would be expected to have a positive impact on these
type of patient outcomes. Process measures hold a lot of value as they
delineate negative and/or positive aspects of the health care process.
This measure will capture the quality of the process of medication
information transfer and help improve those processes. Process
measures, such as these, are building blocks toward improved
coordinated care and discharge planning, providing information that
will improve shared
[[Page 38761]]
decision making and coordination. When developing future measures, we
will take into consideration suggestions about measures that assess the
accuracy of the medication list and whether it was received by the
subsequent provider.
    Comment: A few commenters suggested that CMS work to identify
interoperability solutions to facilitate coordinated care, improve
outcomes and overall quality comparisons related to both Transfer of
Health Information measures. One commenter added that this would
decrease opportunities for errors by providing clinicians and patients
secure access to the most up-to-date medication-related information.
One commenter also suggests that if CMS is required by the IMPACT Act
to adopt these measures, that they do so as an interim step, within a
defined timeframe, while interoperability solutions are explored and
tested. A few commenters stated that while the rule acknowledges that
information may be transferred verbally, on paper or electronically,
CMS has not provided funding to nursing facilities to facilitate
deployment of EMRs. These commenters suggested that meaningful use
incentives be extended to SNFs and other post-acute care providers. One
commenter stated that the use of existing clinical and interoperability
standards should be considered in the development of these and future
measures and that using standardized quality measures and standardized
data will help enable interoperability and access to longitudinal
information to facilitate coordinated care, improved outcomes, and
overall quality comparisons and suggested that CMS leverage ongoing
efforts to adopt data standards and implementation guides for certified
EHRs (such as the USCDI). One commenter cites numerous CMS requirements
and states that they are not sufficiently aligned for purposes of
electronic exchange and, as a result, create significant provider
burden as providers attempt to navigate and comply with these various
requirements. The commenter recommends that CMS seek greater alignment
between its various data collection requirements included in both
finalized and proposed rules.
    Response: We agree with the comments on the importance of
interoperability solutions to support health information transfer. CMS
and ONC are focused on improving interoperability and the timely
sharing of information between providers, patients, families and
caregivers. We believe that PAC provider health information exchange
supports the goals of high quality, personalized, and efficient
healthcare, care coordination and person-centered care, and supports
real-time, data driven, clinical decision making.
    To further support interoperability, we recently released the Data
Element Library (DEL), a new public resource aimed at advancing
interoperable health information exchange by enabling users to view
assessment questions and response options about demographics, medical
problems, and other types of health evaluations and their associated
health IT standards. All data elements adopted for use in the Quality
Reporting programs (QRPs), and not limited to data collected under the
IMPACT Act, will be included in the DEL. In the initial version of the
DEL (https://del.cms.gov/), assessment questions and response options
are mapped to LOINC and SNOMED, where feasible. We also recognize the
importance of leveraging existing standards, obtaining input from
standards setting organizations, and alignment across federal
interoperability efforts. We acknowledge that meaningful use incentives
have not been extended to SNFs and other PAC providers and we will
share these comments with the appropriate CMS staff and other
governmental agencies to ensure they are taken into account as we
continue to encourage adoption of health information technology. The
Transfer of Health Information measures may encourage the electronic
transfer of medication information at transitions. These measures and
related efforts may help accelerate interoperability solutions.
    The Transfer of Health Information measures assess the process of
medication transfer, which can occur through both electronic and non-
electronic means. We would like to clarify that these measures are an
interim step in improving coordinated care, and we also believe that
other interoperable solutions should be explored. Finalizing these
Transfer of Health Information measures will be a first step in
measuring the transfer of this medication-related information.
    Comment: One commenter suggested that we develop a future outcome
measure related to the transfer of medication information.
    Response: We appreciate the suggestion that we develop an outcome
measure related to the transfer of medication information, and agree
that an outcome would be the next step when modifying the Transfer of
Health Information measures. We will take this comment into
consideration as we commence future measure development activities.
    Comment: In comments related to both the Transfer of Health
Information to the Provider and Transfer of Health Information to the
Patient measures, one commenter requested the definition of a
reconciled medication list and quoted from an older version of measure
specifications where a medication profile had been defined.
    Response: We appreciate these comments. We can confirm that as we
tested these measures and gathered consensus input by TEPs and public
comments, the definition of what is a reconciled medication list has
been modified to decrease burden and to align to common clinical
practice. Defining the completeness of that reconciled medication list
is left to the discretion of the providers and patient who are
coordinating this care.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Transfer of Health Information
to the Provider-Post-Acute Care (PAC) Measure under section
1899B(c)(1)(E) of the Act beginning with the FY 2022 SNF QRP as
proposed.
V. (2) Transfer of Health Information to the Patient--Post-Acute Care
(PAC) Measure Beginning With the FY 2022 SNF QRP
    We proposed to adopt the Transfer of Health Information to the
Patient-Post-Acute Care (PAC) measure, a measure that satisfies the
IMPACT Act domain of Transfer of Health Information, with data
collection for discharges beginning October 1, 2020. This process-based
measure assesses whether or not a current reconciled medication list
was provided to the patient, family, or caregiver when the patient was
discharged from a PAC setting to a private home/apartment, a board and
care home, assisted living, a group home, transitional living or home
under care of an organized home health service organization or a
hospice.
(a) Background
    In 2013, 22.3 percent of all acute hospital discharges were
discharged to PAC settings, including 11 percent who were discharged to
home under the care of a home health agency.\55\ Of the Medicare FFS
beneficiaries with a SNF stay in fiscal year 2017, an estimated 11
percent were discharged home with home health services, 41 percent were
discharged home with self-care, and 0.2
[[Page 38762]]
percent were discharged with home hospice services.\56\
---------------------------------------------------------------------------
    \55\ Tian, W. ``An all-payer view of hospital discharge to
postacute care,'' May 2016. Available at https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
    \56\ RTI International analysis of Medicare claims data for
index stays in SNF 2017. (RTI program reference: IB55).
---------------------------------------------------------------------------
    The communication of health information, such as a reconciled
medication list, is critical to ensuring safe and effective patient
transitions from health care settings to home and/or other community
settings. Incomplete or missing health information, such as medication
information, increases the likelihood of a patient safety risk, often
life-threatening.\57\ \58\ \59\ \60\ \61\ Individuals who use PAC care
services are particularly vulnerable to adverse health outcomes due to
their higher likelihood of having multiple comorbid chronic conditions,
polypharmacy, and complicated transitions between care settings.\62\
\63\ Upon discharge to home, individuals in PAC settings may be faced
with numerous medication changes, new medication regimes, and follow-up
details.\64\ \65\ \66\ The efficient and effective communication and
coordination of medication information may be critical to prevent
potentially deadly adverse effects. When care coordination activities
enhance care transitions, these activities can reduce duplication of
care services and costs of care, resolve conflicting care plans, and
prevent medical errors.\67\ \68\
---------------------------------------------------------------------------
    \57\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
    \58\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
    \59\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \60\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
    \61\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
    \62\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
    \63\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation
during the transition to and from long-term care settings: a
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
    \64\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
    \65\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \66\ Sheehan, O.C., Kharrazi, H., Carl, K.J., Leff, B., Wolff,
J.L., Roth, D.L., Gabbard, J., & Boyd, C.M., ``Helping older adults
improve their medication experience (HOME) by addressing medication
regimen complexity in home healthcare,'' Home Healthcare Now. 2018,
Vol. 36(1) pp. 10-19.
    \67\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \68\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C.,
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner,
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and
preventable adverse events among hospitalized children following
implementation of a resident handoff bundle,'' JAMA, 2013, Vol.
310(21), pp. 2262-2270.
---------------------------------------------------------------------------
    Finally, the transfer of a patient's discharge medication
information to the patient, family, or caregiver is common practice and
supported by discharge planning requirements for participation in
Medicare and Medicaid programs.69 70 Most PAC EHR systems
generate a discharge medication list to promote patient participation
in medication management, which has been shown to be potentially useful
for improving patient outcomes and transitional care.\71\
---------------------------------------------------------------------------
    \69\ CMS, ``Revision to state operations manual (SOM), Hospital
Appendix A--Interpretive Guidelines for 42 CFR 482.43, Discharge
Planning'' May 17, 2013. Available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-32.pdf.
    \70\ The State Operations Manual Guidance to Surveyors for Long
Term Care Facilities (Guidance Sec.  483.21(c)(1) Rev. 11-22-17) for
discharge planning process. Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
    \71\ Toles, M., Colon-Emeric, C., Naylor, M.D., Asafu-Adjei, J.,
Hanson, L.C., ``Connect-home: transitional care of skilled nursing
facility patients and their caregivers,'' Am Geriatr Soc., 2017,
Vol. 65(10), pp. 2322-2328.
---------------------------------------------------------------------------
(b) Stakeholder and Technical Expert Panel (TEP) Input
    The proposed measure was developed after consideration of feedback
we received from stakeholders and four TEPs convened by our
contractors. Further, the proposed measure was developed after
evaluation of data collected during two pilot tests we conducted in
accordance with the CMS MMS Blueprint.
    Our measure development contractors constituted a TEP which met on
September 27, 2016,\72\ January 27, 2017,\73\ and August 3, 2017 \74\
to provide input on a prior version of this measure. Based on this
input, we updated the measure concept in late 2017 to include the
transfer of a specific component of health information--medication
information. Our measure development contractors reconvened this TEP on
April 20, 2018 to seek expert input on the measure. Overall, the TEP
members supported the proposed measure, affirming that the measure
provides an opportunity to improve the transfer of medication
information. Most of the TEP members believed that the measure could
improve the transfer of medication information to patients, families,
and caregivers. Several TEP members emphasized the importance of
transferring information to patients and their caregivers in a clear
manner using plain language. A summary of the April 20, 2018 TEP
proceedings titled ``Transfer of Health Information TEP Meeting 4--June
2018'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
    \72\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
    \73\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
    \74\ Ibid.
---------------------------------------------------------------------------
    Our measure development contractors solicited stakeholder feedback
on the proposed measure by requesting comment on the CMS Measures
Management System Blueprint website, and accepted comments that were
submitted from March 19, 2018 to May 3, 2018. Several commenters noted
the
[[Page 38763]]
importance of ensuring that the instruction provided to patients and
caregivers is clear and understandable to promote transparent access to
medical record information and meet the goals of the IMPACT Act. The
summary report for the March 19 to May 3, 2018 public comment period
titled ``IMPACT--Medication Profile Transferred Public Comment Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(c) Pilot Testing
    Between June and August 2018, we held a pilot test involving 24 PAC
facilities/agencies, including five IRFs, six SNFs, six LTCHs, and
seven HHAs. The 24 pilot sites submitted a total of 801 assessments.
Analysis of agreement between coders within each participating facility
(241 qualifying pairs) indicated an 87 percent agreement for this
measure. Overall, pilot testing enabled us to verify its reliability,
components of face validity, and feasibility of being implemented
across PAC settings. Further, more than half of the sites that
participated in the pilot test stated, during debriefing interviews,
that the measure could distinguish facilities or agencies with higher
quality medication information transfer from those with lower quality
medication information transfer at discharge. The pilot test summary
report titled ``Transfer of Health Information 2018 Pilot Test Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(d) Measure Applications Partnership (MAP) Review and Related Measures
    We included the proposed measure in the SNF QRP section of the 2018
MUC list. The MAP conditionally supported this measure pending NQF
endorsement, noting that the measure can promote the transfer of
important medication information to the patient. The MAP recommended
that providers transmit medication information to patients that is easy
to understand because health literacy can impact a person's ability to
take medication as directed. More information about the MAP's
recommendations for this measure is available at http://www.qualityforum.org/Publications/2019/02/MAP_2019_Considerations_for_Implementing_Measures_Final_Report_-_PAC-LTC.aspx.
    Section 1899B(e)(2)(A) of the Act, requires that any measure
specified by the Secretary be endorsed by the entity with a contract
under section 1890(a) of the Act, which is currently the NQF. However,
when a feasible and practical measure has not been NQF-endorsed for a
specified area or medical topic determined appropriate by the
Secretary, section 1899B(e)(2)(B) of the Act allows the Secretary to
specify a measure that is not NQF-endorsed as long as due consideration
is given to the measures that have been endorsed or adopted by a
consensus organization identified by the Secretary. Therefore, in the
absence of any NQF-endorsed measures that address the proposed Transfer
of Health Information to the Patient-Post-Acute Care (PAC), which
requires that at least some of the data used to calculate the measure
be collected as standardized patient assessment data through the post-
acute care assessment instruments, we believe that there is currently
no feasible NQF-endorsed measure that we could adopt under section
1899B(c)(1)(E) of the Act. However, we note that we intend to submit
the proposed measure to the NQF for consideration of endorsement when
feasible.
(e) Quality Measure Calculation
    The calculation of the proposed Transfer of Health Information to
the Patient-Post-Acute Care (PAC) measure would be based on the
proportion of resident stays with a discharge assessment indicating
that a current reconciled medication list was provided to the resident,
family, or caregiver at the time of discharge.
    The proposed measure denominator is the total number of SNF
resident stays ending in discharge to a private home/apartment, a board
and care home, assisted living, a group home, transitional living or
home under care of an organized home health service organization or a
hospice. These locations were selected for inclusion in the denominator
because they are identified as home locations on the discharge
destination item that is currently included on the MDS. The proposed
measure numerator is the number of SNF resident stays with an MDS
discharge assessment indicating a current reconciled medication list
was provided to the resident, family, or caregiver at the time of
discharge. For technical information about this proposed measure we
refer readers to the document titled ``Proposed Specifications for SNF
QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Data for the proposed quality measure would be calculated using data
from the MDS assessment instrument for SNF residents.
    For more information about the data submission requirements we
proposed for this measure, we refer readers to section III.E.1.h.(3) of
this final rule.
    Commenters submitted the following comments related to the proposed
rule's discussion of the SNF QRP Quality Measure Proposals Beginning
with the FY 2022 SNF QRP. A discussion of these comments, along with
our responses, appears below. Comments that applied to both Transfer of
Health Information measures are discussed in section III.E.1.d.(1) of
this final rule.
    Comment: One commenter suggested that CMS use the field's
experience with transferring information to patients and reporting on
the Transfer of Health Information to the Patient-Post-Acute Care (PAC)
Measure to disseminate best practices about how to best convey the
medication list and suggested this include formats and informational
elements helpful to patients and families.
    Response: We have interpreted ``the field'' to mean PAC providers.
Facilities and clinicians should use clinical judgement to guide their
practices around transferring information to patients and how to best
convey the medication list, including identifying the best formats and
informational elements. This may be determined by the patient's
individualized needs in response to their medical condition. CMS does
not determine clinical best practices standards and facilities are
advised to refer to other sources, such as professional guidelines.
    Comment: A couple of comments suggested that the Transfer of Health
Information to the Patient-Post-Acute Care (PAC) Measure require
transfer of the medication list to both the patient and family or
caregiver. One of these commenters also stated that the measure should
assess whether the patient, family or caregiver understands the
medication list and has had a chance to ask questions about it.
    Response: We agree there are times when it is appropriate for the
SNF to provide the medication list to the patient and family and this
decision should be based on clinical judgement. However, because it is
not always necessary or appropriate to provide the medication list to
both the patient and
[[Page 38764]]
family, we are not requiring this for the measure.
    Comment: One comment suggested that CMS adopt standards around the
Transfer of Health Information to Patient measure that ensures a
consultant pharmacist is involved in patient-centered medication
counseling.
    Response: We understand that it is important for patient safety and
outcomes that patients, their family and caregivers have good
understanding of medications and how to take them and the role that
pharmacists fulfill in this process. However, we believe that PAC
providers should rely on their facility policies or standards of
practice to determine who will provide medication counseling to
patients.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Transfer of Health Information
to the Patient-Post-Acute Care (PAC) Measure under section
1899B(c)(1)(E) of the Act beginning with the FY 2022 SNF QRP as
proposed.
VI. (3) Update to the Discharge to Community--Post Acute Care (PAC)
Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) Measure
    In the FY 2020 SNF PPS proposed rule (84 FR 17643) we proposed to
update the specifications for the Discharge to Community--PAC SNF QRP
measure to exclude baseline nursing facility (NF) residents from the
measure. This measure reports a SNF's risk-standardized rate for
Medicare FFS residents who are discharged to the community following a
SNF stay, do not have an unplanned readmission to an acute care
hospital or LTCH in the 31 days following discharge to community, and
who remain alive during the 31 days following discharge to community.
We adopted this measure in the FY 2017 SNF PPS final rule (81 FR 52021
through 52029).
    In the FY 2017 SNF PPS final rule (81 FR 52025), we addressed
public comments recommending exclusion of SNF residents who were
baseline NF residents, as these residents lived in a NF prior to their
SNF stay and may not be expected to return to the community following
their SNF stay. In the FY 2018 SNF PPS final rule (82 FR 36596), we
addressed public comments expressing support for a potential future
modification of the measure that would exclude baseline NF residents;
commenters stated that the exclusion would result in the measure more
accurately portraying quality of care provided by SNFs, while
controlling for factors outside of SNF control.
    We assessed the impact of excluding baseline NF residents from the
measure using CY 2015 and CY 2016 data, and found that this exclusion
impacted both patient- and facility-level discharge to community rates.
We defined baseline NF residents as SNF residents who had a long-term
NF stay in the 180 days preceding their hospitalization and SNF stay,
with no intervening community discharge between the NF stay and
qualifying hospitalization for measure inclusion. Baseline NF residents
represented 10.4 percent of the measure population after all measure
exclusions were applied. Observed resident-level discharge to community
rates were significantly lower for baseline NF residents (2.37 percent)
compared with non-NF residents (53.32 percent). The national observed
resident-level discharge to community rate was 48.01 percent when
baseline NF residents were included in the measure, increasing to 53.32
percent when they were excluded from the measure. After excluding
baseline NF residents, 38.5 percent of SNFs had an increase in their
risk-standardized discharge to community rate that exceeded the
increase in the national observed resident-level discharge to community
rate.
    Based on public comments received and our impact analysis, we
proposed to exclude baseline NF residents from the Discharge to
Community-PAC SNF QRP measure beginning with the FY 2020 SNF QRP, with
baseline NF residents defined as SNF residents who had a long-term NF
stay in the 180 days preceding their hospitalization and SNF stay, with
no intervening community discharge between the NF stay and
hospitalization.
    For additional technical information regarding the Discharge to
Community--PAC SNF QRP measure, including technical information about
the proposed exclusion, we refer readers to the document titled ``Final
Specifications for SNF QRP Quality Measures and Standardized Resident
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We invited public comment on this proposal and received several
comments. A discussion of these comments, along with our responses,
appears below.
    Comment: Several commenters supported the proposed exclusion of
baseline NF residents from the Discharge to Community--PAC SNF QRP
measure. Commenters referred to their recommendation of this exclusion
in prior years and appreciated CMS' willingness to consider and
implement stakeholder feedback. One commenter recommended also
excluding individuals without viable means to return to the community,
such as those who are homeless, dependent on shelters, or unable to
find a safe discharge option. One commenter suggested that CMS instead
consider other quality measures for NF residents, such as functional
status measures, to determine whether residents receive the appropriate
standard of care they need during a long-term NF stay.
    Response: We thank the commenters for their support of the proposed
exclusion of baseline nursing facility residents from this measure, and
for recommending additional exclusions and measures for consideration
for baseline NF residents. We will consider the commenters' suggestions
and would also note that exclusions and risk adjustment require the
presence of reliable and valid data sources.
    Comment: MedPAC did not support the proposed exclusion of baseline
NF residents from the Discharge to Community-PAC SNF QRP measure. They
stated that assessing safe discharge to ``home'' without post-discharge
readmissions or death was also important for the baseline NF resident
population and that excluding these residents would hold nursing homes
harmless for their readmissions and death. MedPAC suggested that CMS
instead expand their definition of ``return to the community'' to
include baseline nursing home residents returning to the nursing home
where they live, as this represents their home or community. MedPAC was
also concerned that providers that mostly treat long-term care
residents could have most stays excluded from the measure, and
consumers using these rates for provider selection may not know that
the measure would reflect only a small share of the provider's stays.
Finally, MedPAC stated that providers should be held accountable for
the quality of care they provide for as much of their Medicare patient
population as feasible.
    Response: We agree that providers should be accountable for quality
of care for as much of their Medicare population as feasible; we
endeavor to do this as much as possible, only specifying exclusions we
believe are necessary for measure validity. We also believe that
monitoring quality of care and outcomes is important for all PAC
patients, including baseline NF residents who return to a NF after
their
[[Page 38765]]
PAC stay. We publicly report several long-stay resident quality
measures on Nursing Home Compare including measures of hospitalization
and emergency department visits.
    Community is traditionally understood as representing non-
institutional settings by policy makers, providers, and other
stakeholders. Including long-term care NF in the definition of
community would confuse this long-standing concept of community and
would misalign with CMS' definition of community in patient assessment
instruments. CMS conceptualized this measure using the traditional
definition of ``community'' and specified the measure as a discharge to
community measure, rather than a discharge to baseline residence
measure.
    Baseline NF residents represent an inherently different patient
population with not only a significantly lower likelihood of discharge
to community settings, but also a higher likelihood of post-discharge
readmissions and death compared with PAC patients who did not live in a
NF at baseline. The inherent differences in patient characteristics and
PAC processes and goals of care for baseline NF residents and non-NF
residents are significant enough that we do not believe risk adjustment
using a NF flag would provide adequate control. While we acknowledge
that a return to nursing home for baseline NF residents represents a
return to their home, this outcome does not align with our measure
concept. Thus, we have chosen to exclude baseline NF residents from the
measure. While we agree that the proposed exclusion could affect
providers differentially since the mix of skilled and long-term care
residents differs across nursing homes, we believe it is necessary for
measure validity. We also appreciate the concern that consumers using
the measures may not know that the measure does not reflect outcomes
for baseline NF residents. We will consider strategies to convey this
information to consumers.
    Comment: One commenter requested that CMS provide the definition of
``long-term'' NF stay in the proposed measure exclusion, requesting
further clarification in the measure specifications.
    Response: We have further clarified the definition of long-term NF
stay in the ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. A long-term NF stay is identified
by the presence of a non-SNF PPS MDS assessment in the 180 days
preceding the qualifying prior acute care admission and index SNF stay.
    After consideration of the public comments, we are finalizing our
proposal to exclude baseline NF residents from the Discharge to
Community--PAC SNF QRP measure. This measure is now NQF-endorsed.
e. SNF QRP Quality Measures, Measure Concepts, and Standardized Patient
Assessment Data Elements Under Consideration for Future Years: Request
for Information
    We sought input on the importance, relevance, appropriateness, and
applicability of each of the measures, standardized patient assessment
data elements (SPADEs), and concepts under consideration listed in the
Table 13 for future years in the SNF QRP.
  Table 13--Future Measures, Measure Concepts, and Standardized Patient
  Assessment Data Elements (SPADEs) Under Consideration for the SNF QRP
------------------------------------------------------------------------

-------------------------------------------------------------------------
Assessment-Based Quality Measures and Measure Concepts:
    Functional maintenance outcomes.
    Opioid use and frequency.
    Exchange of electronic health information and interoperability.
Claims-Based:
    Healthcare-Associated Infections in Skilled Nursing Facility (SNF)--
     claims-based.
Standardized Patient Assessment Data Elements (SPADEs):
    Cognitive complexity, such as executive function and memory.
    Dementia.
    Bladder and bowel continence including appliance use and episodes of
     incontinence.
    Care preferences, advance care directives, and goals of care.
    Caregiver Status.
    Veteran Status.
    Health disparities and risk factors, including education, sex and
     gender identity, and sexual orientation.
------------------------------------------------------------------------
    In the FY 2020 SNF PPS proposed rule, we included a Request for
Information (RFI) related to assessment and claims-based quality
measures and standardized patient assessment data elements. We received
various comments on this RFI, and appreciate the input provided by
commenters.
    Several commenters offered general support for the future measures,
measure concepts, and SPADEs under consideration, however a few
commenters questioned the detail on intent and process for selecting
them.
 Assessment-Based Quality Measures and Measure Concepts
    A few commenters offered support for the addition of assessment-
based quality measures related to functional maintenance outcomes. With
respect to quality measures related to opioid use and frequency, one
commenter offered general support and another commenter suggested
caution in developing opioid related quality measures to ensure that
they do not result unintended consequences that leave patients without
access to critical treatments for pain management. A few commenters
offered general support for exchange of electronic health information
and interoperability. One commenter suggested that CMS enhance its
efforts to develop standards and measures for data exchange and sharing
across all care settings including post-acute care, to explore
approaches to incentivize the adoption of EHRs across the care
continuum, and to develop future measures and SPADEs that use data that
are available within EHRs used by PAC providers.
 Claims-Based
    The claims-based quality measure, Healthcare-Associated Infections
in Skilled Nursing Facility (SNF) received several comments of support,
a few suggesting subcategorization to distinguish SNF-acquired
infections and
[[Page 38766]]
non-SNF-acquired infections such as infections acquired in the hospital
or community.
 Standardized Patient Assessment Data Elements (SPADEs)
    One commenter offered support for the SPADE categories, stating
that each of these SPADE categories represent elements that will
provide a fuller picture of the patients in the SNF setting and could
be used for creating and risk adjusting quality measures.
    Several commenters supported SPADEs related to cognitive complexity
such as executive function and memory, dementia, and caregiver status.
One commenter noted that regularly assessing cognitive function and
mental status presents opportunities for better care and quality of
life, and that regular assessment of caregivers will also result in
better care for the beneficiary and better quality of life for both
individuals. Another commenter suggested that CMS should further
consider the prevalence and clinical and economic burden of agitation
in Alzheimer's disease when evaluating future SPADEs for dementia,
suggesting that treatment of symptoms of agitation in patients with
Alzheimer's disease reduces caregiver burden and the cost of care for
the patient symptoms of agitation in patients with Alzheimer's disease.
One commenter encouraged CMS to continue to place emphasis on the
importance of innovative payment approaches to ensuring the financial
stability of organizations delivering care related to Alzheimer's and
dementia.
    One commenter suggested that it is critical to consider the
patient's needs and experience when measuring the quality of such care
and supported the development and testing of patient experience
measures to ensure reliability as well as validity of the measures.
This commenter suggested development of a standardized tool as part of
the SNF QRP to truly measure patient and/or caregiver experiences in
the SNF setting, initially through a voluntary data collection phase.
    One commenter supported SPADEs focused on bowel and bladder
continence including appliance use and episodes of incontinence.
Another commenter requested that CMS evaluate existing data MDS
elements before adding additional data elements in to SPADEs in the
areas of Dementia and Bladder and Bowel Continence.
    For the collection of SPADE related to education, sex and gender
identity, and sexual orientation, one commenter agreed that gender
identity and sexual orientation are important and relevant to
understanding patient care delivery needs and outcomes, and believes
more information is needed to understand what data points would be
collected. Another commenter proposed that CMS consider adding some
measure of trauma history citing that a history of trauma can result in
increased care needs and that in light of SNFs providing trauma-
informed care, more SNFs will be assessing and addressing trauma and
this should be captured in the measures.
    One commenter endorsed adding Veteran status as a SPADE, as it may
encourage more patient-centered care practices and system-wide focus on
older Veterans' post-acute healthcare needs and may also encourage more
research/analysis of Veteran status as a health determinant in PAC
settings, particularly for investigators outside of VA for whom this
information may be more difficult to access.
    Finally, there were suggestions for SPADE development for other
specific clinical areas such as behavioral and bariatric care.
f. Standardized Patient Assessment Data Reporting Beginning With the FY
2022 SNF QRP
    Section 1888(e)(6)(B)(i)(III) of the Act requires that, for fiscal
years 2019 and each subsequent year, SNFs must report standardized
patient \75\ assessment data (SPADE) required under section 1899B(b)(1)
of the Act. Section 1899B(a)(1)(C) of the Act requires, in part, the
Secretary to modify the PAC assessment instruments in order for PAC
providers, including SNFs, to submit SPADEs under the Medicare program.
Section 1899B(b)(1)(A) of the Act requires PAC providers to submit
SPADEs under applicable reporting provisions (which, for SNFs, is the
SNF QRP) with respect to the admission and discharge of an individual
(and more frequently as the Secretary deems appropriate), and section
1899B(b)(1)(B) of the Act defines standardized patient assessment data
as data required for at least the quality measures described in section
1899B(c)(1) of the Act and that is with respect to the following
categories: (1) Functional status, such as mobility and self-care at
admission to a PAC provider and before discharge from a PAC provider;
(2) cognitive function, such as ability to express ideas and to
understand, and mental status, such as depression and dementia; (3)
special services, treatments, and interventions, such as need for
ventilator use, dialysis, chemotherapy, central line placement, and
total parenteral nutrition; (4) medical conditions and comorbidities,
such as diabetes, congestive heart failure, and pressure ulcers; (5)
impairments, such as incontinence and an impaired ability to hear, see,
or swallow, and (6) other categories deemed necessary and appropriate
by the Secretary.
---------------------------------------------------------------------------
    \75\ In the FY 2018 SNF PPS final rule, we used the term
``standardized resident assessment data'' to refer to standardized
assessment data elements collected from SNF residents. However, in
this final rule and going forward, we will use the term
``standardized patient assessment data'' to refer to the collect of
SPADEs from SNF residents.
---------------------------------------------------------------------------
    In the FY 2018 SNF PPS proposed rule (82 FR 21059 through 21076),
we proposed to adopt SPADEs that would satisfy the first five
categories. In the FY 2018 SNF PPS final rule, commenters expressed
support for our adoption of SPADEs in general, including support for
our broader standardization goal and support for the clinical
usefulness of specific proposed SPADEs. However, we did not finalize
the majority of our SPADE proposals in recognition of the concern
raised by many commenters that we were moving too fast to adopt the
SPADEs and modify our assessment instruments in light of all of the
other requirements we were also adopting under the IMPACT Act at that
time (82 FR 36598 through 36600). In addition, we noted our intention
to conduct extensive testing to ensure that the standardized patient
assessment data elements we select are reliable, valid, and appropriate
for their intended use (82 FR 36599).
    We did, however, finalize the adoption of SPADEs for two of the
categories described in section 1899B(b)(1)(B) of the Act: (1)
Functional status: Data elements currently reported by SNFs to
calculate the measure Application of Percent of Long-Term Care Hospital
Patients with an Admission and Discharge Functional Assessment and a
Care Plan That Addresses Function (NQF #2631); and (2) Medical
conditions and comorbidities: The data elements used to calculate the
pressure ulcer measures, Percent of Residents or Patients with Pressure
Ulcers That Are New or Worsened (Short Stay) (NQF #0678) and the
replacement measure, Changes in Skin Integrity Post-Acute Care:
Pressure Ulcer/Injury. We stated that these data elements were
important for care planning, known to be valid and reliable, and
already being reported by SNFs for the calculation of quality measures.
    Since we issued the FY 2018 SNF PPS final rule, SNFs have had an
opportunity to familiarize themselves with other new reporting
requirements that we have adopted under the IMPACT Act. We have also
conducted further testing of the SPADEs, as
[[Page 38767]]
described more fully below, and believe that this testing supports the
use of the SPADEs in our PAC assessment instruments. Therefore, we have
proposed to adopt many of the same SPADEs that we previously proposed
to adopt, along with other SPADEs.
    We proposed that SNFs would be required to report these SPADEs
beginning with the FY 2022 SNF QRP. If finalized, SNFs would be
required to report these data with respect to SNF admissions and
discharges that occur between October 1, 2020 and December 31, 2020 for
the FY 2022 SNF QRP. Beginning with the FY 2023 SNF QRP, we proposed
that SNFs must report data with respect to admissions and discharges
that occur during the subsequent calendar year (for example, CY 2021
for the FY 2023 SNF QRP, CY 2022 for the FY 2024 SNF QRP).
    We also proposed that SNFs that submit the Hearing, Vision, Race,
and Ethnicity SPADEs with respect to admission will be deemed to have
submitted those SPADEs with respect to both admission and discharge,
because it is unlikely that the assessment of those SPADEs at admission
will differ from the assessment of the same SPADEs at discharge.
    In selecting the proposed SPADEs below, we considered the burden of
assessment-based data collection and aimed to minimize additional
burden by evaluating whether any data that is currently collected
through one or more PAC assessment instruments could be collected as
SPADEs. In selecting the SPADEs below, we also took into consideration
the following factors with respect to each data element:
    (1) Overall clinical relevance;
    (2) Interoperable exchange to facilitate care coordination during
transitions in care;
    (3) Ability to capture medical complexity and risk factors that can
inform both payment and quality; and
    (4) Scientific reliability and validity, general consensus
agreement for its usability.
    In identifying the SPADEs proposed below, we additionally drew on
input from several sources, including TEPs held by our data element
contractor, public input, and the results of a recent National Beta
Test of candidate data elements conducted by our data element
contractor (hereafter ``National Beta Test'').
    The National Beta Test collected data from 3,121 patients and
residents across 143 PAC providers (26 LTCHs, 60 SNFs, 22 IRFs, and 35
HHAs) from November 2017 to August 2018 to evaluate the feasibility,
reliability, and validity of candidate data elements across PAC
settings. The 3,121 patients and residents with an admission assessment
included 507 in LTCHs, 1,167 in SNFs, 794 in IRFs, and 653 in HHAs. The
National Beta Test also gathered feedback on the candidate data
elements from staff who administered the test protocol in order to
understand usability and workflow of the candidate data elements. More
information on the methods, analysis plan, and results for the National
Beta Test are available in the document titled, ``Development and
Evaluation of Candidate Standardized Patient Assessment Data Elements:
Findings from the National Beta Test (Volume 2),'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Further, to inform the proposed SPADEs, we took into account
feedback from stakeholders, as well as from technical and clinical
experts, including feedback on whether the candidate data elements
would support the factors described above. Where relevant, we also took
into account the results of the Post-Acute Care Payment Reform
Demonstration (PAC PRD) that took place from 2006 to 2012.
    Comment: One commenter expressed support for the addition of SPADEs
to the SNF-Resident Assessment Instrument (RAI), noting that many of
them are already collected and reported on today. A second commenter
noted support for the use of existing MDS items as SPADEs, noting that
it will not increase provider burden. Another commenter recognized that
data standardization will help facilitate appropriate payment reforms
and appropriate quality measures.
    Response: We thank the commenters for their support for the
proposed SPADEs. We wish to clarify that we proposed the addition of
the SPADEs to the MDS for SNFs, which is one component of the RAI. We
agree with the commenters that many of the SPADEs are already collected
and reported currently through the MDS, and that data standardization
will help facilitate appropriate payment reforms and quality measures.
    Comment: One commenter noted appreciation for CMS' transparency and
responsiveness to stakeholders and noted that the SPADEs are much
improved from earlier draft versions and reflect many of the concerns
and recommendations CMS had previously offered. The commenter stated
that the SPADEs appear to reflect a reasonable compromise between the
need to collect meaningful standardized resident assessment data across
the continuum of care to improve care, and the need to minimize
provider administrative burden.
    Response: We appreciate the commenter's recognition of our
stakeholder engagement activities.
    Comment: One commenter noted support for the goals of the IMPACT
Act, but expressed concern about the scope and timing of proposed
changes, including the SPADEs. The same commenter went on to urge CMS
to share with the public a data use strategy and analysis plan for the
SPADEs so that providers better understand how CMS will assess the
potential usability of the SPADEs to support changes to payment and
quality programs.
    Response: We thank the commenter for their support of the goals of
the IMPACT Act and appreciate their concern about the proposed changes.
Since we issued the FY 2018 SNF PPS final rule, SNFs have had an
opportunity to familiarize themselves with other new reporting
requirements that we have adopted under the IMPACT Act and prepare for
additional changes. We have provided regular updates to stakeholders
and gathered feedback through Special Open Door Forums and other events
as described in our proposal. CMS will continue to communicate and
collaborate with stakeholders by soliciting input on how the SPADEs
will be used in the SNF QRP through future rulemaking.
    We are in the process of creating research identifiable files of
data collected in the National Beta Test. We anticipate that these
files will be available through a data use agreement sometime in 2019.
We also note that additional volumes of the National Beta Test report
will be available in late 2019. This report contains supplemental
analyses of the SPADEs that may be of interest to stakeholders.
    Comment: Some commenters stated support but noted reservations. One
commenter described the SPADEs as an appropriate start, but noted that
the SPADEs cannot stand alone, and must be built upon in order to be
useful for risk adjustment and quality measurement. Similarly, another
commenter urged CMS to continue working with clinicians and researchers
to ensure that the SPADEs are collecting valid, reliable, and useful
data, and to continue to refine and explore new data elements for
standardization. Yet another commenter urged CMS to be cautious in its
implementation of some of the SPADEs, specifically those associated
with social determinants of health (SDOH).
[[Page 38768]]
    Response: We agree with the commenter's statement that the SPADEs
are an appropriate start for standardization, but we disagree that they
cannot stand alone. While we intend to evaluate SPADE data as they are
submitted and explore additional opportunities for standardization, we
also believe that the SPADEs as proposed represent an important core
set of information about clinical status and patient characteristics
and they will be useful for quality measurement. We would welcome
continued input, recommendations, and feedback from stakeholders--
including clinicians and researchers--about refinement and new
development of SPADEs. Input can be shared with CMS through our PAC
Quality Initiatives email address: [email protected]. We
acknowledge the commenter's request that we be cautious implementing
some SPADEs, particularly those associated with SDOH. We believe that
our SPADE development process has been transparent and engaged
stakeholders, as described in our proposals. However, we will monitor
the implementation of the SPADEs in order to identify any issues that
might arise.
    Comment: Two commenters recommended that CMS seek greater alignment
in its various data collection activities across settings. One
commenter recommended alignment of SPADEs with the U.S. Core Data set
for Interoperability (USCDI) once there is final rulemaking for ONC's
Interoperability, Information Blocking and ONC Health IT Certification
Program regulation. Although the USCDI only have current applicability
in an acute care setting, the commenter pointed out that alignment,
where possible (that is Cognitive Measures, Treatment Continuity, SDOH,
Pain, Hearing, Speech, and Vision), would be advantageous to the
quality and continuity of a patient's care. A second commenter also
recommended alignment of SPADEs with the USCDI, but also mentioned the
Requirements for Participation for Long Term Care Facilities (RoPs) and
the Hospital Discharge Planning proposed rule as alternative guidelines
with which to align the SPADEs. For data elements that are unlikely to
change between settings, this commenter also urged CMS to require
settings that are already collecting these data elements to send them
to the next setting (that is, from acute care to PAC settings).
    Response: We appreciate the commenters' recommendation for the
potential for greater alignment to reduce burden and improve continuity
of information as patients move between health care provider types. We
are proposing SPADEs to satisfy the requirements of the IMPACT Act,
which focuses on the four PAC provider types. At this time, alignment
of patient assessment requirements with acute care and long-term care
facilities is out of scope for these proposals. We will take the
commenters' recommendations into consideration with future data element
development work.
    Comment: A commenter expressed concerns about the level of evidence
to support the SPADEs shared by CMS from the National Beta Test. The
commenter described several concerns about the scope and implementation
of the National Beta Test, including the representativeness of SNFs
included in the sample, the share of total SNF patients included in the
National Beta Test, the reported exclusion of patients with
communication and cognitive impairments, and the exclusion of non-
English speaking patients, and described how these concerns compromise
their confidence in the findings of the National Beta Test. The
commenter also remarked on the lack of information about clinical
characteristics that has been shared with stakeholders, limiting their
ability to draw conclusions about the data, and requested that CMS
release the data from the National Beta Test to be analyzed by third
parties.
    Response: In a supplementary document to the proposed rule (the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html), we described key findings from
the National Beta Test related to the proposed SPADEs. We also referred
readers to an initial volume of the National Beta Test report that
details the methodology of the field test (``Development and Evaluation
of Candidate Standardized Patient Assessment Data Elements: Findings
from the National Beta Test (Volume 2),'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html). Additional volumes of the
National Beta Test report will be available in late 2019. In addition,
we are committed to making data available for researchers and the
public to analyze, and to doing so in a way that protects the privacy
of patients and providers who participated in the National Beta Test.
We are in the process of creating research identifiable files that we
anticipate will be available through a data use agreement sometime in
2019.
    To address the commenter's specific concerns, we note that the
National Beta Test was designed to generate valid and robust national
SPADE performance estimates for each of the four PAC provider types,
which required acceptable geographic diversity, sufficient sample size,
and reasonable coverage of the range of clinical characteristics. To
meet these requirements, the National Beta Test was carefully designed
so that data could be collected from a wide range of environments,
allowing for thorough evaluation of candidate SPADE performance in all
PAC settings. The approach included a stratified random sample, to
maximize generalizability, and subsequent analyses included extensive
checks on the sampling design.
    The National Beta Test did not exclude non-communicative patients/
residents; rather, it had two distinct samples, one of which focused on
patients/residents who were able to communicate, and one of which
focused on patient/residents who were not able to communicate. The
assessment of non-communicative patients/residents differed primarily
in that observational assessments were substituted for some interview
assessments. Non-English speaking patients were excluded from the
National Beta Test due to feasibility constraints during the field
test. Including limited English proficiency patients/residents in the
sample would have required the Beta test facilities to engage or
involve translators during the test assessments. We anticipated that
this would have added undue complexity to what facilities/agencies were
being requested to do, and would have undermined the ability of
facility/agency staff to complete the requested number of assessments
during the study period. Moreover, there is strong existing evidence
for the feasibility of all patient/resident interview SPADEs included
in this proposed rule (BIMS section III.E.1.g.(1) in this final rule),
Pain Interference (section III.E.1.g.(4) in this final rule), PHQ
(section III.E.1.g.(2) in this final rule) when administered in other
languages, either through standard PAC workflow (for example, as tested
and currently collected in the MDS 3.0) and/or through rigorous
translation and testing (for example, PHQ). For all these reasons, we
determined that the performance of translated versions of these
patient/resident interview
[[Page 38769]]
SPADEs did not need to be further evaluated. In addition, because their
exclusion did not threaten our ability to achieve acceptable geographic
diversity, sufficient sample size, and reasonable coverage of the range
of PAC patient/resident clinical characteristics, the exclusion of
limited English proficiency patients/residents was not considered a
limitation to interpretation of the National Beta Test results.
    Comment: Some commenters expressed concerns for the scope of the
standardized patient assessment data proposals. These commenters were
concerned that the proposed standardized patient assessment data
reporting requirements will impose significant burden on providers,
given the volume of new standardized patient assessment data elements
that were proposed to be simultaneously added to the MDS within a short
timeframe.
    Response: We acknowledge the additional burden that the SPADEs will
impose on SNF providers and residents. Our development and selection
process for the SPADEs we are adopting in this final rule prioritized
data elements that are essential to comprehensive patient care. In
selecting the SPADEs that we are adopting, we took into consideration
clinical relevance, ability to capture medical complexity, data element
performance, and expert and stakeholder input. We maintain that there
will be significant benefit associated with each of the SPADEs to
providers and patients, in that they are clinically useful (for
example, for care planning), they support patient-centered care, and
they will promote interoperability and data exchange between providers.
During the SPADE development process, we were cognizant of the changes
that providers will need to implement these additions to the MDS. We
note that CMS has modified many current MDS data elements to reduce the
impact of SPADEs on overall burden. This effort resulted in the total
addition of only 59.5 items across the PPS admission and PPS discharge
assessments. In addition, changes to the SNF QRP were coordinated
across CMS' quality, payment, and policy teams so that collection of
SPADES will begin after the October 1, 2019 implementation of the
Patient Driven Payment Model. The PDPM streamlines the PPS assessments
schedule eliminating the need for the 14-day, 30-day, 60-day and 90-day
assessments. When burden is evaluated in these broader terms we believe
providers will find the burden of the SPADES to be negligible.
    Comment: Two commenters expressed concern that this additional
burden was not justified because, in their view, there was limited or
no evidence for the SPADEs to improve patient care.
    Response: The IMPACT Act requires that we foster interoperable data
exchange between PAC providers, including SNFs, by establishing a core
set of data elements. We contend that supporting care transitions
through improved data exchange will improve patient care.
    Comment: One commenter stated that time burden (as in, ``time-to-
complete'') estimates are underestimated. This commenter stated that
because testing conditions focused on cognitively intact, English-
speaking patients with no speech or language deficits, the estimates of
impact to providers' time and resources is inadequate.
    Response: We disagree with the commenter that the National Beta
Test time-to-complete estimates are underestimates. We wish to clarify
that the National Beta Test did exclude patients/residents who were not
able to communicate in English but did not categorically exclude
patients with cognitive impairment or patients with speech or language
deficits. Therefore, we believe that time-to-complete estimates from
the National Beta Test capture the full range of SNF residents who are
able to communicate, including those with speech and language deficits.
    Comment: To reduce administrative burden, some commenters'
recommended changes to when and how SPADEs would be collected. One
commenter was concerned that asking patients or their care partners to
repeat questions throughout the admission could create a perception of
poor communication and ineffectiveness that could result in an
undesirable patient experience. This commenter urged CMS to reduce the
number of additional standardized patient assessment data elements to
ensure questions and categories do not create an undue administrative
and patient burden. Other recommendations included collecting data only
at admission when answers are unlikely to change between admission and
discharge, adopting a staged implementation or only a subset of the
proposed data elements, and that CMS explore options for obtaining
these data via claims or voluntary reporting only.
    Response: We appreciate the commenters' recommendations. We
acknowledge that several SPADEs being finalized in this rule require
the patient to be asked questions directly. We believe that direct
patient assessment and patient-reported outcomes on these topics have
benefits for providers and patients. These data elements support
patient-centered care by soliciting the patient's perspective, and
better information on a patient's status should improve the care the
patient receives.
    To support data exchange between settings, and to support quality
measurement, section 1899B(b)(1)(A) of the Act requires that the SPADEs
be collected with respect to both admission and discharge. In the FY
2020 SNF PPS proposed rule (84 FR 17644), we proposed that SNFs that
submit four SPADEs with respect to admission will be deemed to have
submitted those SPADEs with respect to both admission and discharge
because we asserted that it is unlikely that the assessment of those
SPADEs at admission would differ from the assessment of the same SPADEs
at discharge. We note that a patient's ability to hear or ability to
see are more likely to change between admission and discharge than, for
example, a patient's self-report of his or her race, ethnicity,
preferred language, or need for interpreter services, (although it is
possible that any of these data elements may change). The Hearing and
Vision SPADEs are also different from the other SPADEs (that is, Race,
Ethnicity, Preferred Language, and Interpreter Services) because
evaluation of sensory status is a fundamental part of the ongoing
nursing assessment conducted for SNF patients. Therefore, significant
changes that occur in a patient's hearing or vision impairment during
the SNF stay would be captured as part of the clinical record, even if
they are not assessed by a SPADE. After consideration of public
comments discussed in sections III.E.1.g.(5) and (6) of this final
rule, we will deem SNFs that submit the Hearing, Vision, Race,
Ethnicity, Preferred Language, and Interpreter Services SPADEs with
respect to admission to have submitted with respect to both admission
and discharge.
    Regarding the number of SPADEs proposed, we note that these items
span many substantive clinical areas and patient characteristics, and
are comprised of a mix of patient interview and non-interview
assessments. We contend that we have been highly selective when
identifying SPADEs, and that our selections reflect a balanced approach
to assessor and patient burden versus need for assessment data to
support care planning, foster interoperability, and inform future
quality measures. We will take into consideration the recommendation to
obtain patient data from claims data in future work.
    Comment: A commenter encouraged CMS to create and make transparent
a
[[Page 38770]]
data use strategy and analysis plan for the SPADEs so PAC providers,
including SNFs, better understand how the agency will further assess
the adequacy and usability of the SPADEs. This commenter noted
appreciation for CMS' efforts to provide opportunities for stakeholder
communication and input, but also urged CMS to develop additional lines
of communication with stakeholders, such as a multi-disciplinary
stakeholder workgroup representing all PAC settings to advise on
strategic and operational implications of implementation and a data
analytics advisory group to assist CMS in establishing a framework for
SPADE analysis and ongoing assessment. Another commenter believed that
the SPADEs would provide a more accurate reflection on the resident's
SNF resource use and could inform refinements to case-mix methodology.
This commenter stated that CMS should include the potential impact of
the SPADEs on case-mix payment methodology in the final rule.
    Response: We appreciate the commenter's recommendation. It is our
intention, as delineated by the IMPACT Act, to use the SPADE data to
inform care planning, the common standards and definitions to
facilitate interoperability, and to allow for comparing assessment data
for standardized measures. In order to maintain open lines of
communication with our stakeholders, we have used the public comment
periods, TEPs, Subject Matter Expert working groups, stakeholder
meetings, data forums, MLNs, open door forums, help desks, in-person
trainings, webinars with communication with the public, ``We Want to
Hear From You'' sessions, and have had stakeholders serve as
consultants on our measure work. If there are any other opportunities
for communication and comment, we will publish those opportunities. We
will continue to communicate with stakeholders about how the SPADEs
will be used in quality programs, as those plans are established, by
soliciting input during the development process and establishing use of
the SPADEs in quality programs through future rulemaking.
    Comment: One commenter recommended that CMS focus on providing
funding and administrative support to allow improvements and
standardization to the electronic medical record to allow effective
interoperability across all post-acute sites.
    Response: We appreciate the commenter's recommendation. At this
time, funding for electronic medical record adoption and support is not
authorized for PAC providers.
    Final decisions on the SPADEs are given below, following more
detailed comments on each SPADE proposal.
g. Standardized Patient Assessment Data by Category
VII. (1) Cognitive Function and Mental Status Data
    A number of underlying conditions, including dementia, stroke,
traumatic brain injury, side effects of medication, metabolic and/or
endocrine imbalances, delirium, and depression, can affect cognitive
function and mental status in PAC patient and resident populations.\76\
The assessment of cognitive function and mental status by PAC providers
is important because of the high percentage of patients and residents
with these conditions,\77\ and because these assessments provide
opportunity for improving quality of care.
---------------------------------------------------------------------------
    \76\ National Institute on Aging. (2014). Assessing Cognitive
Impairment in Older Patients. A Quick Guide for Primary Care
Physicians. Retrieved from https://www.nia.nih.gov/alzheimers/publication/assessing-cognitive-impairment-older-patients.
    \77\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute
Care Payment Reform Demonstration (Final report, Volume 4 of 4).
Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------
    Symptoms of dementia may improve with pharmacotherapy, occupational
therapy, or physical activity,78 79 80 and promising
treatments for severe traumatic brain injury are currently being
tested.\81\ For older patients and residents diagnosed with depression,
treatment options to reduce symptoms and improve quality of life
include antidepressant medication and
psychotherapy,82 83 84 85 and targeted services, such as
therapeutic recreation, exercise, and restorative nursing, to increase
opportunities for psychosocial interaction.\86\
---------------------------------------------------------------------------
    \78\ Casey D.A., Antimisiaris D., O'Brien J. (2010). Drugs for
Alzheimer's Disease: Are They Effective? Pharmacology &
Therapeutics, 35, 208-211.
    \79\ Graff M.J., Vernooij-Dassen M.J., Thijssen M., Dekker J.,
Hoefnagels W.H., Rikkert M.G.O. (2006). Community Based Occupational
Therapy for Patients with Dementia and their Care Givers: Randomised
Controlled Trial. BMJ, 333(7580): 1196.
    \80\ Bherer L., Erickson K.I., Liu-Ambrose T. (2013). A Review
of the Effects of Physical Activity and Exercise on Cognitive and
Brain Functions in Older Adults. Journal of Aging Research, 657508.
    \81\ Giacino J.T., Whyte J., Bagiella E., et al. (2012).
Placebo-controlled trial of amantadine for severe traumatic brain
injury. New England Journal of Medicine, 366(9), 819-826.
    \82\ Alexopoulos G.S., Katz I.R., Reynolds C.F. 3rd, Carpenter
D., Docherty J.P., Ross R.W. (2001). Pharmacotherapy of depression
in older patients: a summary of the expert consensus guidelines.
Journal of Psychiatric Practice, 7(6), 361-376.
    \83\ Arean P.A., Cook B.L. (2002). Psychotherapy and combined
psychotherapy/pharmacotherapy for late life depression. Biological
Psychiatry, 52(3), 293-303.
    \84\ Hollon S.D., Jarrett R.B., Nierenberg A.A., Thase M.E.,
Trivedi M., Rush A.J. (2005). Psychotherapy and medication in the
treatment of adult and geriatric depression: which monotherapy or
combined treatment? Journal of Clinical Psychiatry, 66(4), 455-468.
    \85\ Wagenaar D, Colenda CC, Kreft M, Sawade J, Gardiner J,
Poverejan E. (2003). Treating depression in nursing homes: practice
guidelines in the real world. J Am Osteopath Assoc. 103(10), 465-
469.
    \86\ Crespy SD, Van Haitsma K, Kleban M, Hann CJ. Reducing
Depressive Symptoms in Nursing Home Residents: Evaluation of the
Pennsylvania Depression Collaborative Quality Improvement Program. J
Healthc Qual. 2016. Vol. 38, No. 6, pp. e76-e88.
---------------------------------------------------------------------------
    In alignment with our Meaningful Measures Initiative, accurate
assessment of cognitive function and mental status of patients and
residents in PAC is expected to make care safer by reducing harm caused
in the delivery of care; promote effective prevention and treatment of
chronic disease; strengthen person and family engagement as partners in
their care; and promote effective communication and coordination of
care. For example, standardized assessment of cognitive function and
mental status of patients and residents in PAC will support
establishing a baseline for identifying changes in cognitive function
and mental status (for example, delirium), anticipating the patient's
or resident's ability to understand and participate in treatments
during a PAC stay, ensuring patient and resident safety (for example,
risk of falls), and identifying appropriate support needs at the time
of discharge or transfer. Standardized patient assessment data elements
will enable or support clinical decision-making and early clinical
intervention; person-centered, high quality care through facilitating
better care continuity and coordination; better data exchange and
interoperability between settings; and longitudinal outcome analysis.
Therefore, reliable standardized patient assessment data elements
assessing cognitive function and mental status are needed in order to
initiate a management program that can optimize a patient's or
resident's prognosis and reduce the possibility of adverse events.
    The data elements related to cognitive function and mental status
were first proposed as standardized patient assessment data elements in
the FY 2018 SNF PPS proposed rule (82 FR 21060 through 21063). In
response to our proposals, a few commenters noted that the proposed
data elements did not capture some dimensions of cognitive function and
mental status, such as functional cognition, communication, attention,
concentration, and agitation. One commenter also suggested that other
cognitive assessments should be
[[Page 38771]]
considered for standardization. Another commenter stated support for
the standardized assessment of cognitive function and mental status,
because it could support appropriate use of skilled therapy for
beneficiaries with degenerative conditions, such as dementia, and
appropriate use of medications for behavioral and psychological
symptoms of dementia.
    We invited comments on our proposals to collect as standardized
patient assessment data the following data with respect to cognitive
function and mental status.
    Commenters submitted the following comments related to the proposed
rule's discussion of the cognitive function and mental status data
elements.
    Comment: A few commenters were supportive of the proposal to adopt
the BIMS, CAM, and PHQ-2 to 9 as SPADEs on the topic of cognitive
function and mental status. One commenter agreed that standardizing
cognitive assessments will allow providers to identify changes in
status, support clinical decision-making, and improve care continuity
and interventions.
    Response: We thank the commenters for their support. We selected
the Cognitive Function and Mental Status data elements for proposal as
standardized data in part because of the attributes that the commenters
noted.
    Comment: A few commenters noted limitations of these SPADEs to
fully assess all areas of cognition and mental status, particularly
mild to moderate cognitive impairment, and performance deficits that
may be related to cognitive impairment. A few commenters urged CMS to
continue exploring assessment tools on the topic of cognition and to
include a more comprehensive assessment of cognitive function for use
in PAC settings, noting that highly vulnerable patients with a mild
cognitive impairment cannot be readily identified through the current
SPADEs.
    Response: We acknowledge the limitations of the SPADEs to fully
assess all areas of cognition and mental status. We have strived to
balance the scope and level of detail of the data elements against the
potential burden placed on patients and providers. In our past work, we
evaluated the potential of several different cognition assessment for
use as standardized data elements in PAC settings. We ultimately
decided on the data elements in our proposal as a starting point, and
we welcome continued input, recommendations, and feedback from
stakeholders about additional data elements for standardization, which
can be shared with CMS through our PAC Quality Initiatives email
address: [email protected].
    Comment: Regarding future use of these data elements, one commenter
recommended that CMS monitor the use of the cognition and mental status
SPADEs as risk adjustors and make appropriate adjustments to
methodology as needed.
    Response: We intend to monitor data submitted via the proposed
SPADEs and will consider the use of SPADEs as risk adjustors in the
future. We will also continue to review recommendation and feedback
from stakeholders regarding candidate data for standardization that
would provide meaningful data for PAC providers and patients.
    Final decisions on the SPADEs are given below, following more
detailed comments on each SPADE proposal.
 Brief Interview for Mental Status (BIMS)
    In the FY 2020 SNF PPS proposed rule (84 FR 17645 through 17646),
we proposed that the data elements that comprise the BIMS meet the
definition of standardized patient assessment data with respect to
cognitive function and mental status under section 1899B(b)(1)(B)(ii)
of the Act.
    As described in the FY 2018 SNF PPS Proposed Rule (82 FR 21060
through 21061), dementia and cognitive impairment are associated with
long-term functional dependence and, consequently, poor quality of life
and increased health care costs and mortality.\87\ This makes
assessment of mental status and early detection of cognitive decline or
impairment critical in the PAC setting. The intensity of routine
nursing care is higher for patients and residents with cognitive
impairment than those without, and dementia is a significant variable
in predicting readmission after discharge to the community from PAC
providers.\88\
---------------------------------------------------------------------------
    \87\ Ag[uuml]ero-Torres, H., Fratiglioni, L., Guo, Z., Viitanen,
M., von Strauss, E., & Winblad, B. (1998). ``Dementia is the major
cause of functional dependence in the elderly: 3-year follow-up data
from a population-based study.'' Am J of Public Health 88(10): 1452-
1456.
    \88\ RTI International. Proposed Measure Specifications for
Measures Proposed in the FY 2017 IRF QRP NPRM. Research Triangle
Park, NC. 2016.
---------------------------------------------------------------------------
    The BIMS is a performance-based cognitive assessment screening tool
that assesses repetition, recall with and without prompting, and
temporal orientation. The data elements that make up the BIMS are seven
questions on the repetition of three words, temporal orientation, and
recall that result in a cognitive function score. The BIMS was
developed to be a brief, objective screening tool, with a focus on
learning and memory. As a brief screener, the BIMS was not designed to
diagnose dementia or cognitive impairment, but rather to be a
relatively quick and easy to score assessment that could identify
cognitively impaired patients as well as those who may be at risk for
cognitive decline and require further assessment. It is currently in
use in two of the PAC assessments: the MDS used by SNFs and the IRF-PAI
used by IRFs. For more information on the BIMS, we refer readers to the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The data elements that comprise the BIMS were first proposed as
standardized patient assessment data elements in the FY 2018 SNF PPS
proposed rule (82 FR 21060 through 21061). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted from August 12 to September 12, 2016
expressed support for use of the BIMS, noting that it is reliable,
feasible to use across settings, and will provide useful information
about patients and residents. We also stated that the data collected
through the BIMS will provide a clearer picture of patient or resident
complexity, help with the care planning process, and be useful during
care transitions and when coordinating across providers. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, a
few commenters supported the use of the BIMS as standardized patient
assessment data elements. Other commenters were critical of the BIMS,
noting its limitations for assessing mild cognitive impairment and
functional cognition. Another stated that the BIMS should be
administered with respect to discharge, as well as admission to capture
changes during the stay. One expressed concern that the BIMS cannot
[[Page 38772]]
be completed by patients and residents who are unable to communicate.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
BIMS was included in the National Beta Test of candidate data elements
conducted by our data element contractor from November 2017 to August
2018. Results of this test found the BIMS to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the BIMS in the National Beta Test can be found in the
document titled ``Final Specifications for SNF Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements and the TEP supported the
assessment of patient or resident cognitive status at both admission
and discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums (SODFs) and small-group
discussions with PAC providers and other stakeholders in 2018 for the
purpose of updating the public about our on-going SPADE development
efforts. Finally, on November 27, 2018, our data element contractor
hosted a public meeting of stakeholders to present the results of the
National Beta Test and solicit additional comments. General input on
the testing and item development process and concerns about burden were
received from stakeholders during this meeting and via email through
February 1, 2019. Some commenters also expressed concern that the BIMS,
if used alone, may not be sensitive enough to capture the range of
cognitive impairments, including mild cognitive impairment (MCI). A
summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We understand the concerns raised by stakeholders that BIMS, if
used alone, may not be sensitive enough to capture the range of
cognitive impairments, including functional cognition and MCI, but note
that the purpose of the BIMS data elements as SPADEs is to screen for
cognitive impairment in a broad population. We also acknowledge that
further cognitive tests may be required based on a patient's condition
and will take this feedback into consideration in the development of
future standardized patient assessment data elements. However, taking
together the importance of assessing for cognitive status, stakeholder
input, and strong test results, we proposed that the BIMS data elements
meet the definition of standardized patient assessment data with
respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act and to adopt the BIMS as standardized
patient assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the BIMS data elements.
    Comment: Several commenters support the use of the BIMS to assess
cognitive function and mental status.
    Response: We thank the commenters for their support of the BIMS
data element.
    Comment: One commenter supported the collection of BIMS at both
admission and discharge and believes it will result in more complete
data and better care.
    Response: We thank the commenter for their support of collecting
the BIMS data element at admission and discharge.
    Comment: Several commenters stated that the BIMS fails to detect
mild cognitive impairment or functional cognition, differentiate
cognitive impairment from a language impairment, link impairment to
functional limitation, or identify issues with problem solving and
executive function. One commenter recommended use of the Development of
Outpatient Therapy Payment Alternatives (DOTPA) items for PAC as well
as a screener targeting functional cognition.
    Response: We recognize that the BIMS assesses components of
cognition and does not, alone, provide a comprehensive assessment of
potential cognitive impairment. However, we would also like to clarify
that any SPADE or set of data elements that may be proposed in the
future would be intended as a minimum assessment and would not limit
the ability of providers to conduct more comprehensive assessment of
cognition to identify the complexities or potential impacts of
cognitive impairment that the commenter describes.
    We evaluated the suitability of the DOTPA, as well as other
screening tools that targeted functional cognition, by engaging our
TEP, through ``alpha'' feasibility testing, and through soliciting
input from stakeholders. At the second meeting of TEP in March 2017,
members questioned the use of data elements that rely on assessor
observation and judgment, such as DOTPA CARE tool items, and favored
other assessments of cognition that required patient interview or
patient actions. The TEP also discussed performance-based assessment of
functional cognition. These are assessments that require patients to
respond by completing a simulated task, such as ordering from a menu,
or reading medication instructions and simulating the taking of
medications, as required by the Performance Assessment of Self-Care
Skills (PASS) items.
    In Alpha 2 feasibility testing, which was conducted between April
and July 2017, we included a subset of items from the DOTPA as well as
the PASS. Findings of that test identified several limitations of the
DOTPA items for use as SPADEs, such as relatively long to administer (5
to 7 minutes), especially in the LTCH setting. Assessors also indicated
that these items had low relevance for SNF and LTCH patients. In
addition, interrater reliability was highly variable among the DOTPA
items, both overall and across settings, with some items showing very
low agreement (as low as 0.34) and others showing excellent agreement
(as high as 0.81). Similarly, findings of the Alpha 2 feasibility test
identified several limitations of the PASS for use as SPADEs. The PASS
was relatively time-intensive to administer (also 5 to 7 minutes), many
patients in HHAs and IRFs needed assistance completing the PASS tasks,
and missing data were prevalent. Unlike the DOTPA items, interrater
reliability was consistently high overall for PASS (ranging from 0.78
to 0.92), but the high reliability was not deemed to outweigh
fundamental feasibility concerns related to administration challenges.
A summary report for the Alpha 2 feasibility testing titled
``Development and Maintenance of Standardized Cross Setting Patient
Assessment Data for Post-Acute Care: Summary Report of Findings from
Alpha 2 Pilot Testing'' is available at
[[Page 38773]]
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Alpha-2-SPADE-Pilot-Summary-Document.pdf.
    Feedback was obtained on the DOTPA and other assessments of
functional cognition through a call for input that was open from April
26, 2017 to June 26, 2017. While we received support for the DOTPA,
PASS, and other assessments of functional cognition, commenters also
raised concerns about the reliability of the DOTPA, given that it is
based on staff evaluation, and the feasibility of the PASS, given that
the simulated medication task requires props, such as a medication
bottle with printed label and pill box, which may not be accessible in
all settings. A summary report for the April 26 to June 26, 2017 public
comment period titled ``Public Comment Summary Report 2'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Public-Comment-Summary-Report_Standardized-Patient-Assessment-Data-Element-Work_PC2_Jan-2018.pdf.
    Based on the input from our TEP, results of alpha feasibility
testing, and input from stakeholders, we decided to propose the BIMS
for standardization at this time due to the body of research literature
supporting its feasibility and validity, its relative brevity, and its
existing use in the MDS and IRF-PAI.
    Comment: One commenter stated that the BIMS is a screening tool for
cognition, and not necessarily an assessment item for confirming a
diagnosis.
    Response: As stated previously, the BIMS was developed to be a
brief, objective screening tool, with a focus on learning and memory.
It is designed to be a relatively quick and easy to score assessment
that could identify cognitively impaired patients as well as those who
may be at risk for cognitive decline and require further assessment. We
recognize that the BIMS assesses components of cognition and does not,
alone, provide a comprehensive assessment of potential cognitive
impairment. However, we would also like to clarify that any SPADE or
set of data elements that may be proposed in the future would be
intended as a minimum assessment and would not limit the ability of
providers to conduct more comprehensive assessment of cognition to
identify the complexities or potential impacts of cognitive impairment
that the commenter describes.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the BIMS as standardized patient
assessment data beginning with the FY 2022 SNF QRP as proposed.
 Confusion Assessment Method (CAM)
    In the FY 2020 SNF PPS proposed rule (84 FR 17646 through 17647),
we proposed that the data elements that comprise the Confusion
Assessment Method (CAM) meet the definition of standardized patient
assessment data with respect to cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21061),
the CAM was developed to identify the signs and symptoms of delirium.
It results in a score that suggests whether a patient or resident
should be assigned a diagnosis of delirium. Because patients and
residents with multiple comorbidities receive services from PAC
providers, it is important to assess delirium, which is associated with
a high mortality rate and prolonged duration of stay in hospitalized
older adults.\89\ Assessing these signs and symptoms of delirium is
clinically relevant for care planning by PAC providers.
---------------------------------------------------------------------------
    \89\ Fick, D.M., Steis, M.R., Waller, J.L., & Inouye, S.K.
(2013). ``Delirium superimposed on dementia is associated with
prolonged length of stay and poor outcomes in hospitalized older
adults.'' J of Hospital Med 8(9): 500-505.
---------------------------------------------------------------------------
    The CAM is a patient assessment that screens for overall cognitive
impairment, as well as distinguishes delirium or reversible confusion
from other types of cognitive impairment. The CAM is currently in use
in two of the PAC assessments: A four-item version of the CAM is used
in the MDS in SNFs and a six-item version of the CAM is used in the
LTCH CARE Data Set (LCDS) in LTCHs. We proposed the four-item version
of the CAM that assesses acute change in mental status, inattention,
disorganized thinking, and altered level of consciousness. For more
information on the CAM, we refer readers to the document titled ``Final
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The data elements that comprise the CAM were first proposed as
standardized patient assessment data elements in the FY 2018 SNF PPS
proposed rule (82 FR 21061). In that proposed rule, we stated that the
proposal was informed by input we received on the CAM through a call
for input published on the CMS Measures Management System Blueprint
website. Input submitted from August 12 to September 12, 2016 expressed
support for use of the CAM, noting that it would provide important
information for care planning and care coordination and, therefore,
contribute to quality improvement. We also stated that those commenters
had noted the CAM is particularly helpful in distinguishing delirium
and reversible confusion from other types of cognitive impairment. A
summary report for the August 12 to September 12, 2016 public comment
period titled ``SPADE August 2016 Public Comment Summary Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, a
few commenters supported the use of the CAM as standardized patient
assessment data elements, with one noting that it distinguishes
delirium or reversible confusion from other types of cognitive
impairments to share across settings for care coordination.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
CAM was included in the National Beta Test of candidate data elements
conducted by our data element contractor from November 2017 to August
2018. Results of this test found the CAM to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the CAM in the National Beta Test can be found in the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although they did not
specifically discuss the CAM data elements, the TEP supported the
assessment of patient or resident cognitive status with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/
[[Page 38774]]
Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-
Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-
Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for delirium,
stakeholder input, and strong test results, we proposed that the CAM
data elements meet the definition of standardized patient assessment
data with respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act and to adopt the CAM as standardized
patient assessment data elements for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the CAM data elements.
    Comment: Several commenters support the use of the CAM to assess
cognitive function and mental status.
    Response: We thank the commenters for their support of the CAM data
element.
    Comment: One commenter believed the CAM would be difficult to
administer and raised concerns about the training that staff would
receive in order to ensure that administration is consistent and valid.
    Response: We appreciate the commenter's recommendation to provide
clear training for administering the CAM. We note that the CAM is
already collected on the MDS. We will take this recommendation into
consideration in our review of the current training information for the
MDS.
    Comment: One commenter stated that the CAM is a screening tool for
cognition, and not necessarily an assessment item for confirming a
diagnosis.
    Response: We agree with the commenter that the CAM assessment
alone, is not sufficient for confirming a diagnosis of delirium. We
also recognize that the CAM assesses components of cognition and does
not, alone, provide a comprehensive assessment of potential cognitive
impairment. However, we would also like to clarify that any SPADE or
set of data elements is intended as a minimum assessment and would not
limit the ability of providers to conduct more comprehensive assessment
of cognition to identify the complexities or potential impacts of
cognitive impairment, such as delirium.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the CAM as standardized patient
assessment data beginning with the FY 2022 SNF QRP as proposed.
VIII. (2) Patient Health Questionnaire-2 to 9 (PHQ-2 to 9)
    In the FY 2020 SNF PPS proposed rule (84 FR 17647 through 17648),
we proposed that the Patient Health Questionnaire-2 to 9 (PHQ-2 to 9)
data elements meet the definition of standardized patient assessment
data with respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act. The proposed data elements are based on
the PHQ-2 mood interview, which focuses on only the two cardinal
symptoms of depression, and the longer PHQ-9 mood interview, which
assesses presence and frequency of nine signs and symptoms of
depression. The name of the data element, the PHQ-2 to 9, refers to an
embedded a skip pattern that transitions residents with a threshold
level of symptoms in the PHQ-2 to the longer assessment of the PHQ-9.
The skip pattern is described further below.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21062
through 21063), depression is a common and under-recognized mental
health condition. Assessments of depression help PAC providers better
understand the needs of their patients and residents by: Prompting
further evaluation after establishing a diagnosis of depression;
elucidating the patient's or resident's ability to participate in
therapies for conditions other than depression during their stay; and
identifying appropriate ongoing treatment and support needs at the time
of discharge.
    The proposed PHQ-2 to 9 is based on the PHQ-9 mood interview. The
PHQ-2 consists of questions about only the first two symptoms addressed
in the PHQ-9: Depressed mood and anhedonia (inability to feel
pleasure), which are the cardinal symptoms of depression. The PHQ-2 has
performed well as a screening tool for identifying depression, to
assess depression severity, and to monitor patient mood over
time.90 91 If a patient demonstrates signs of depressed mood
and anhedonia under the PHQ-2, then the patient is administered the
lengthier PHQ-9. This skip pattern (also referred to as a gateway) is
designed to reduce the length of the interview assessment for residents
who fail to report the cardinal symptoms of depression. The design of
the PHQ-2 to 9 reduces the burden that would be associated with the
full PHQ-9, while ensuring that patients with indications of depressive
symptoms based on the PHQ-2 receive the longer assessment.
---------------------------------------------------------------------------
    \90\ Li, C., Friedman, B., Conwell, Y., & Fiscella, K. (2007).
``Validity of the Patient Health Questionnaire 2 (PHQ-2) in
identifying major depression in older people.'' J of the A
Geriatrics Society, 55(4): 596-602.
    \91\ L[ouml]we, B., Kroenke, K., & Gr[auml]fe, K. (2005).
``Detecting and monitoring depression with a two-item questionnaire
(PHQ-2).'' J of Psychosomatic Research, 58(2): 163-171.
---------------------------------------------------------------------------
    Components of the proposed data elements are currently used in the
OASIS for HHAs (PHQ-2) and the MDS for SNFs (PHQ-9). We proposed
altering the administration instructions for the existing data elements
to adopt the PHQ-2 to 9 gateway logic, meaning that administration of
the full PHQ-9 is contingent on resident responses to questions about
the cardinal symptoms of depression. For more information on the PHQ-2
to 9, we refer readers to the document titled ``Final Specifications
for SNF QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The PHQ-2 data elements were first proposed as SPADEs in the FY
2018 SNF PPS proposed rule (82 FR 21062 through 21063). In that
proposed rule we stated that the proposal was informed by input we
received from the TEP convened by our data element contractor on April
6 and 7, 2016. The TEP members particularly noted that the brevity of
the PHQ-2 made it feasible to administer with low burden for both
assessors and PAC patients or residents. A summary of the April 6 and
7, 2016 TEP meeting titled ``SPADE Technical Expert Panel Summary
(First
[[Page 38775]]
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
That proposed rule was also informed by public input through a call for
input published on the CMS Measures Management System Blueprint
website. Input was submitted from August 12 to September 12, 2016 on
three versions of the PHQ depression screener: The PHQ-2; the PHQ-9;
and the PHQ-2 to 9 with the skip pattern design. Many commenters
provided feedback on using the PHQ-2 for the assessment of mood.
Overall, commenters believed that collecting these data elements across
PAC provider types was appropriate, given the role that depression
plays in well-being. Several commenters expressed support for an
approach that would use PHQ-2 as a gateway to the longer PHQ-9 while
still potentially reducing burden on most patients and residents, as
well as test administrators, and ensuring the administration of the
PHQ-9, which exhibits higher specificity,\92\ for patients and
residents who showed signs and symptoms of depression on the PHQ-2. A
summary report for the August 12 to September 12, 2016 public comment
period titled ``SPADE August 2016 Public Comment Summary Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
    \92\ Arroll B, Goodyear-Smith F, Crengle S, Gunn J, Kerse N,
Fishman T, et al. Validation of PHQ-2 and PHQ-9 to screen for major
depression in the primary care population. Annals of family
medicine. 2010;8(4):348-353. doi: 10.1370/afm.1139 pmid:20644190;
PubMed Central PMCID: PMC2906530.
---------------------------------------------------------------------------
    In response to our proposal to use the PHQ-2 in the FY 2018 SNF PPS
proposed rule, a few commenters supported screening residents for
depression with the PHQ-2. One commenter opposed the replacement of the
PHQ-9 on the MDS with PHQ-2 because of the clinical significance of
depression on quality of care and resident outcomes in the SNF
population. Another expressed concern about the use of multi-step
``gateway'' questions, because use of the PHQ-2 and PHQ-9 may result in
data not being standardized across settings and providers gathering
data unrelated to the appropriateness of care.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
PHQ-2 to 9 was included in the National Beta Test of candidate data
elements conducted by our data element contractor from November 2017 to
August 2018. Results of this test found the PHQ-2 to 9 to be feasible
and reliable for use with PAC patients and residents. More information
about the performance of the PHQ-2 to 9 in the National Beta Test can
be found in the document titled ``Final Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the PHQ-2 to
9. The TEP was supportive of the PHQ-2 to 9 data element set as a
screener for signs and symptoms of depression. The TEP's discussion
noted that symptoms evaluated by the full PHQ-9 (for example,
concentration, sleep, appetite) had relevance to care planning and the
overall well-being of the patient or resident, but that the gateway
approach of the PHQ-2 to 9 would be appropriate as a depression
screening assessment, as it depends on the well-validated PHQ-2 and
focuses on the cardinal symptoms of depression. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for depression,
stakeholder input, and strong test results, we proposed that the PHQ-2
to 9 data elements meet the definition of standardized patient
assessment data with respect to cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the Act and to adopt the PHQ-2 to 9
data elements as standardized patient assessment data elements for use
in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the PHQ-2 to 9 data elements.
    Comment: Several commenters support the use of the PHQ-2 to 9 to
assess cognitive function and mental status.
    Response: We thank the commenters for their support of the PHQ-2 to
9.
    Comment: One commenter stated that the PHQ-2 to 9 is a screening
tool for depression, and not necessarily an assessment item for
confirming a diagnosis.
    Response: We agree with the commenter than the PHQ-2 to 9 alone is
not sufficient for confirming a diagnosis of depression. Rather, the
PHQ-2 to 9 is a screening tool that identifies residents who should
receive further evaluation for depression. We would also like to
clarify that any SPADE or set of data elements is intended as a minimum
assessment and would not limit the ability of providers to conduct a
more comprehensive assessment of depression to identify the
complexities or potential impacts of depression.
    Comment: One commenter noted that experts in geriatric psychiatry
have identified care transitions as a prime period for intervening in
suicide risk among older adults. This commenter was concerned that
there would be no universal screening for suicide risk in patients
discharged from SNFs unless the patient meets the required threshold on
the PHQ-2 assessment and suggested that CMS consider adding the suicide
ideation item from the PHQ-9 to the PHQ-2 at points of transition (for
example discharge and transition to the community or between settings)
as a step toward universal screening of suicide risk.
    Response: We appreciate the commenter's concern for a universal
screening for suicide risk. The PHQ-2 screens for the cardinal symptoms
of depression, but does not ask about being bothered ``by thoughts that
you would
[[Page 38776]]
be better off dead, or hurting yourself in some way.'' \93\ We will
take the commenter's recommendation into consideration in future item
development work. We note that despite not being adopted as a SPADE,
individual providers have the ability to include this particular
question or any screening or assessment tools that they believe would
benefit their ability to provide high-quality care to their residents.
---------------------------------------------------------------------------
    \93\ The Patient Health Questionnaire-9 (PHQ-9) states: ``Over
the last 2 weeks, have you been bothered by any of the following
problems?'' The ninth response option state: ``Thoughts that you
would be better off dead, or of hurting yourself in some way.''
---------------------------------------------------------------------------
    Comment: Lastly, one commenter expressed confusion about how
depression relates to cognitive function.
    Response: Section 1899B(b)(1)(B)(ii) of the Act specifies that the
category of ``cognitive function, such as ability to express ideas and
to understand, and mental status, such as depression and dementia.''
This category includes both cognitive function and mental status. The
PHQ-2 to 9 data elements do not pertain to cognitive function, but do
pertain to mental status. After careful consideration of the public
comments we received, we are finalizing our proposal to adopt the PHQ-2
to 9 data elements as standardized patient assessment data beginning
with the FY 2022 SNF QRP as proposed.
IX. (3) Special Services, Treatments, and Interventions Data
    Special services, treatments, and interventions performed in PAC
can have a major effect on an individual's health status, self-image,
and quality of life. The assessment of these special services,
treatments, and interventions in PAC is important to ensure the
continuing appropriateness of care for the patients and residents
receiving them, and to support care transitions from one PAC provider
to another, an acute care hospital, or discharge. In alignment with our
Meaningful Measures Initiative, accurate assessment of special
services, treatments, and interventions of patients and residents
served by PAC providers is expected to make care safer by reducing harm
caused in the delivery of care; promote effective prevention and
treatment of chronic disease; strengthen person and family engagement
as partners in their care; and promote effective communication and
coordination of care.
    For example, standardized assessment of special services,
treatments, and interventions used in PAC can promote patient and
resident safety through appropriate care planning (for example,
mitigating risks such as infection or pulmonary embolism associated
with central intravenous access), and identifying life-sustaining
treatments that must be continued, such as mechanical ventilation,
dialysis, suctioning, and chemotherapy, at the time of discharge or
transfer. Standardized assessment of these data elements will enable or
support: Clinical decision-making and early clinical intervention;
person-centered, high quality care through, for example, facilitating
better care continuity and coordination; better data exchange and
interoperability between settings; and longitudinal outcome analysis.
Therefore, reliable data elements assessing special services,
treatments, and interventions are needed to initiate a management
program that can optimize a patient's or resident's prognosis and
reduce the possibility of adverse events.
    A TEP convened by our data element contractor provided input on all
of the proposed data elements for special services, treatments, and
interventions. In a meeting held on January 5 and 6, 2017, this TEP
found that these data elements are appropriate for standardization
because they would provide useful clinical information to inform care
planning and care coordination. The TEP affirmed that assessment of
these services and interventions is standard clinical practice, and
that the collection of these data by means of a list and checkbox
format would conform with common workflow for PAC providers. A summary
of the January 5 and 6, 2017 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Second Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Comments on the category of special services, treatments, and
interventions were also submitted by stakeholders during the FY 2018
SNF PPS proposed rule (82 FR 21063 through 21073) public comment
period. A comment across all special services, treatments, and
interventions data elements requested that the additional reporting
burden of the special services, treatments, and interventions data
elements be addressed in payment calculations. Another comment
submitted for several special services, treatments, and interventions
data elements requested additional time be allowed before the providers
are required to submit these data. One commenter expressed concern
about increased reporting burden of the data elements proposed in FY
2018 because they would require an additional look-back time frame.
Several commenters supported the inclusion of nutritional data elements
as standardized data elements noting their importance in capturing
information on care coordination and safe care transitions. One
commenter noted the limitations of the nutritional data elements,
namely that they do not capture information on swallowing or the
clinical rationale for feeding/nutrition needs.
    Information on data element performance in the National Beta Test,
which collected data between November 2017 and August 2018, is reported
within each data element proposal below. Clinical staff who
participated in the National Beta Test supported these data elements
because of their importance in conveying patient or resident
significant health care needs, complexity, and progress. However,
clinical staff also noted that, despite the simple ``check box'' format
of these data element, they sometimes needed to consult multiple
information sources to determine a patient's or resident's treatments.
    We invited comments on our proposals to collect as standardized
patient assessment data the following data with respect to special
services, treatments, and interventions.
    Commenters submitted the following comments related to the proposed
rule's discussion of the special services, treatments, and
interventions data elements.
    Comment: Some commenters were supportive of collecting these data
elements, one noting that collection will help to better inform CMS and
SNF providers on the severity and needs of patients in this setting.
    Response: We thank the commenters for their support of these items.
We selected the Special Services, Treatments, and Interventions data
elements for proposal as standardized data in part because of the
attributes noted.
    Comment: One commenter expressed concern about the relevance of the
Special Services, Treatments, and Interventions data elements to
patients in SNFs. This and other commenters also noted concern around
burden of completion of these data elements, in particular, the
documentation burden taking away from patient care in the SNF settings.
    Response: We acknowledge the commenters' concern for burden on
completion of these data elements. We
[[Page 38777]]
note that many of the SPADEs in this category are already collected on
the MDS and the additional burden introduced by the sub-elements is
minimal. To the extent that assessment and reporting may detract from
time spent in direct patient care, we assert that SNFs already have
processes in place to provide special services, treatments, and
interventions for patients upon admission, during their stay, and at
the time of discharge. We are asking that this available information be
recorded on the Part A Discharge assessment.
    Comment: One commenter was concerned about the reliability of the
Special Services, Treatments, and Interventions data elements, noting
that the results of the National Beta Test indicated that these data
elements had a low interrater reliability kappa statistic, relative to
other data elements in the test.
    Response: In the category of Special Services, Treatments, and
Interventions, for SPADEs where kappas could be calculated, 1 data
element and 2 sub-elements demonstrated overall reliabilities in the
moderate range (0.41-0.60) and only 1 sub-element demonstrated an
overall reliability in the slight/poor range (0.00-0.20). These overall
reliabilities were as follows: 0.60 for the Therapeutic Diet data
element, 0.55 for the ``Continuous'' sub-element of Oxygen Therapy,
0.46 for the ``Other'' sub-element of IV Medications, and 0.13 for the
``Anticoagulant'' sub-element of IV Medications. However, the overall
reliabilities for all other Special Services, Treatments, and
Interventions data elements and sub-elements where kappas could be
calculated were substantial/good or excellent/almost perfect. When
looking at percent agreement--an alternative measure of interrater
agreement--values of overall percent agreement for all Special
Services, Treatments, and Interventions SPADEs and sub-elements ranged
from 80 to 100 percent.
    Comment: One commenter expressed concern that the Special Services,
Treatments, and Interventions data elements assess the presence or
absence of something rather than the clinical rationale or patient
outcomes. This commenter stressed the importance of bringing this
assessment to the ``next level'' in order to determine impact of these
treatments on patients' outcomes.
    Response: We agree with the commenter's concern that recording the
presence or absence of certain treatments is only a first step in
characterizing the complexity that is often the cause of a patient's
receipt of special services, treatments, and interventions. We would
like to clarify that all the SPADEs we proposed are intended as a
minimum assessment and do not limit the ability of providers to conduct
a more comprehensive evaluation of a patient's situation to identify
the potential impacts on outcomes that the commenter describes.
    Final decisions on the SPADEs are given below, following more
detailed comments on each SPADE proposal.
(a) Cancer Treatment: Chemotherapy (IV, Oral, Other)
    In the FY 2020 SNF PPS proposed rule (84 FR 17649 through 17650),
we proposed that the Chemotherapy (IV, Oral, Other) data element meets
the definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21063
through 21064), chemotherapy is a type of cancer treatment that uses
drugs to destroy cancer cells. It is sometimes used when a patient has
a malignancy (cancer), which is a serious, often life-threatening or
life-limiting condition. Both intravenous (IV) and oral chemotherapy
have serious side effects, including nausea/vomiting, extreme fatigue,
risk of infection due to a suppressed immune system, anemia, and an
increased risk of bleeding due to low platelet counts. Oral
chemotherapy can be as potent as chemotherapy given by IV, and can be
significantly more convenient and less resource-intensive to
administer. Because of the toxicity of these agents, special care must
be exercised in handling and transporting chemotherapy drugs. IV
chemotherapy is administered either peripherally, or more commonly,
given via an indwelling central line, which raises the risk of
bloodstream infections. Given the significant burden of malignancy, the
resource intensity of administering chemotherapy, and the side effects
and potential complications of these highly-toxic medications,
assessing the receipt of chemotherapy is important in the PAC setting
for care planning and determining resource use. The need for
chemotherapy predicts resource intensity, both because of the
complexity of administering these potent, toxic drug combinations under
specific protocols, and because of what the need for chemotherapy
signals about the patient's underlying medical condition. Furthermore,
the resource intensity of IV chemotherapy is higher than for oral
chemotherapy, as the protocols for administration and the care of the
central line (if present) for IV chemotherapy require significant
resources.
    The Chemotherapy (IV, Oral, Other) data element consists of a
principal data element (Chemotherapy) and three response option sub-
elements: IV chemotherapy, which is generally resource-intensive; Oral
chemotherapy, which is less invasive and generally requires less
intensive administration protocols; and a third category, Other,
provided to enable the capture of other less common chemotherapeutic
approaches. This third category is potentially associated with higher
risks and is more resource intensive due to chemotherapy delivery by
other routes (for example, intraventricular or intrathecal). If the
assessor indicates that the resident is receiving chemotherapy on the
principal Chemotherapy data element, the assessor would then indicate
by which route or routes (for example, IV, Oral, Other) the
chemotherapy is administered.
    A single Chemotherapy data element that does not include the
proposed three sub-elements is currently in use in the MDS in SNFs. We
proposed to expand the existing Chemotherapy data element in the MDS to
include sub-elements for IV, Oral, and Other. For more information on
the Chemotherapy (IV, Oral, Other) data element, we refer readers to
the document titled ``Final Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Chemotherapy data element was first proposed as a standardized
patient assessment data element in the FY 2018 SNF PPS proposed rule
(82 FR 21063 through 21064). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted from August 12 to September 12, 2016 expressed support
for the IV Chemotherapy data element and suggested it be included as
standardized patient assessment data. We also stated that those
commenters had noted that assessing the use of chemotherapy services is
relevant to share across the care continuum to facilitate care
coordination and care transitions and noted the validity of the data
element. Commenters also noted the importance of capturing all types of
chemotherapy, regardless of route, and stated that
[[Page 38778]]
collecting data only on patients and residents who received
chemotherapy by IV would limit the usefulness of this standardized data
element. A summary report for the August 12 to September 12, 2016
public comment period titled ``SPADE August 2016 Public Comment Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of Chemotherapy (IV, Oral,
Other) as standardized patient assessment data elements.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Chemotherapy data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the
Chemotherapy data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Chemotherapy data element in the National Beta Test can be found in the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP members
did not specifically discuss the Chemotherapy data element, the TEP
members supported the assessment of the special services, treatments,
and interventions included in the National Beta Test with respect to
both admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for chemotherapy,
stakeholder input, and strong test results, we proposed that the
Chemotherapy (IV, Oral, Other) data element with a principal data
element and three sub-elements meet the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Chemotherapy (IV, Oral, Other) data element as standardized
patient assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Chemotherapy (IV, Oral, Other) data element.
    Comment: One commenter was supportive of collecting this data
element.
    Response: We thank the commenter for the support of the
Chemotherapy data element.
    Comment: One commenter agreed that it is important to know if a
patient is receiving chemotherapy for cancer and the method of
administration, but also expressed concern about the lack of an
association with a patient outcome. This commenter noted that
implications of chemotherapy for patients needing speech-language
pathology services include chemotherapy-related cognitive impairment,
dysphagia, and speech and voice related deficits.
    Response: We appreciate the commenter's concern. We agree with the
commenter that chemotherapy can create related treatment needs for
patients, such as the examples noted by the commenter. We believe that
it is not feasible for SPADEs to capture all of a patient's needs
related to any given treatment, and we maintain that the Special
Services, Treatments, and Interventions SPADEs provide a common
foundation of clinical assessment, which can be built on by the
individual provider or a patient's care team.
    Comment: One commenter noted concern around burden of completion of
the Chemotherapy data element, in particular the additional
administrative burden because this data element adds sub-elements to an
existing MDS item. However, the commenter also stated their belief that
the Chemotherapy data element would provide a more accurate reflection
of residents' resource needs that could inform case-mix payment
methodology.
    Response: We appreciate the commenter's concern for administrative
burden. We agree that assessment of Chemotherapy received by patients
in the SNF setting would provide important information for care
planning and resource use in SNFs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Chemotherapy (IV, Oral, Other)
data element as standardized patient assessment data beginning with the
FY 2022 SNF QRP as proposed.
(b) Cancer Treatment: Radiation
    In the FY 2020 SNF PPS proposed rule (84 FR 17650 through 17651),
we proposed that the Radiation data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21064
through 21065), radiation is a type of cancer treatment that uses high-
energy radioactivity to stop cancer by damaging cancer cell DNA, but it
can also damage normal cells. Radiation is an important therapy for
particular types of cancer, and the resource utilization is high, with
frequent radiation sessions required, often daily for a period of
several weeks. Assessing whether a patient or resident is receiving
radiation therapy is important to determine resource utilization
because PAC patients and residents will need to be transported to and
from radiation treatments, and monitored and treated for side effects
after receiving this intervention. Therefore, assessing the receipt of
radiation therapy, which would compete with other care processes given
the time burden, would be important for care planning and care
coordination by PAC providers.
    The proposed data element consists of the single Radiation data
element. The
[[Page 38779]]
Radiation data element is currently in use in the MDS in SNFs. For more
information on the Radiation data element, we refer readers to the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Radiation data element was first proposed as a SPADE in the FY
2018 SNF PPS proposed rule (82 FR 21064 through 21065). In that
proposed rule, we stated that the proposal was informed by input we
received through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted from August 12 to
September 12, 2016, expressed support for the Radiation data element,
noting its importance and clinical usefulness for patients and
residents in PAC settings, due to the side effects and consequences of
radiation treatment on patients and residents that need to be
considered in care planning and care transitions, the feasibility of
the item, and the potential for it to improve quality. A summary report
for the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment Summary Report'' is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of Radiation as a standardized
patient assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Radiation data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Radiation
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Radiation data
element in the National Beta Test can be found in the document titled
``Final Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP members
did not specifically discuss the Radiation data element, the TEP
members supported the assessment of the special services, treatments,
and interventions included in the National Beta Test with respect to
both admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for radiation,
stakeholder input, and strong test results, we proposed that the
Radiation data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Radiation data element as standardized patient assessment data for
use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Radiation data element.
    Comment: One commenter was supportive of collecting this data
element.
    Response: We thank the commenter for the support of the Radiation
data element.
    Comment: One commenter expressed concern that the Radiation data
element assesses whether a patient is receiving radiation for cancer
treatment, but does not identify the rationale for and outcomes
association with radiation. The commenter noted that implications of
radiation for patients needing speech-language pathology services
include reduced head and neck range of motion due to radiation or
severe fibrosis, scar bands, and reconstructive surgery complications
and that these can impact both communication and swallowing abilities.
    Response: We appreciate the commenter's concern. We agree with the
commenter that radiation can create related treatment needs for
patients, such as the examples noted by the commenter. We believe that
it is not feasible for SPADEs to capture all of a patient's needs
related to any given treatment, and we maintain that the Special
Services, Treatments, and Interventions SPADEs provide a common
foundation of clinical assessment, which can be built on by the
individual provider or a patient's care team.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Radiation data element as
standardized patient assessment data beginning with the FY 2022 SNF QRP
as proposed.
(c) Respiratory Treatment: Oxygen Therapy (Intermittent, Continuous,
High-Concentration Oxygen Delivery System)
    In the FY 2020 SNF PPS proposed rule (84 FR 17651 through 17652),
we proposed that the Oxygen Therapy (Intermittent, Continuous, High-
Concentration Oxygen Delivery System) data element meets the definition
of standardized patient assessment data with respect to special
services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21065),
oxygen therapy provides a patient or resident with extra oxygen when
medical conditions such as chronic obstructive pulmonary disease,
pneumonia, or severe asthma prevent the patient or resident from
getting enough oxygen from breathing. Oxygen administration is a
resource-intensive intervention, as it requires specialized equipment
such as a source of oxygen, delivery systems (for
[[Page 38780]]
example, oxygen concentrator, liquid oxygen containers, and high-
pressure systems), the patient interface (for example, nasal cannula or
mask), and other accessories (for example, regulators, filters,
tubing). The data element proposed here captures patient or resident
use of three types of oxygen therapy (intermittent, continuous, and
high-concentration oxygen delivery system), which reflects the
intensity of care needed, including the level of monitoring and bedside
care required. Assessing the receipt of this service is important for
care planning and resource use for PAC providers.
    The proposed data element, Oxygen Therapy, consists of the
principal Oxygen Therapy data element and three response option sub-
elements: Continuous (whether the oxygen was delivered continuously,
typically defined as > =14 hours per day); Intermittent; or High-
concentration oxygen delivery system. Based on public comments and
input from expert advisors about the importance and clinical usefulness
of documenting the extent of oxygen use, we added a third sub-element,
high-concentration oxygen delivery system, to the sub-elements, which
previously included only intermittent and continuous. If the assessor
indicates that the resident is receiving oxygen therapy on the
principal oxygen therapy data element, the assessor then would indicate
the type of oxygen the patient receives (for example, Continuous,
Intermittent, High-concentration oxygen delivery system).
    These three proposed sub-elements were developed based on similar
data elements that assess oxygen therapy, currently in use in the MDS
in SNFs (``Oxygen Therapy''), previously used in the OASIS (``Oxygen
(intermittent or continuous)''), and a data element tested in the PAC
PRD that focused on intensive oxygen therapy (``High O2 Concentration
Delivery System with FiO2 > 40 percent''). For more information on the
proposed Oxygen Therapy (Continuous, Intermittent, High-concentration
oxygen delivery system) data element, we refer readers to the document
titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Oxygen Therapy (Continuous, Intermittent) data element was
first proposed as standardized patient assessment data in the FY 2018
SNF PPS proposed rule (82 FR 21065). In that proposed rule, we stated
that the proposal was informed by input we received on the single data
element, Oxygen (inclusive of intermittent and continuous oxygen use),
through a call for input published on the CMS Measures Management
System Blueprint website. Input submitted from August 12 to September
12, 2016 expressed the importance of the Oxygen data element, noting
feasibility of this item in PAC, and the relevance of it to
facilitating care coordination and supporting care transitions, but
suggesting that the extent of oxygen use be documented. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, a
few commenters supported the adoption of Oxygen Therapy (Continuous,
Intermittent) as a standardized patient assessment data element.
Another commenter recommended that an option for high-concentration
oxygen be added. In response to public comments, we added a third sub-
element for ``High-Concentration Oxygen Delivery System'' to the Oxygen
Therapy data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Oxygen Therapy data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Oxygen
Therapy data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Oxygen Therapy data element in the National Beta Test can be found in
the document titled ``Final Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Oxygen Therapy data element, the TEP supported
the assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing oxygen therapy,
stakeholder input, and strong test results, we proposed that the Oxygen
Therapy (Continuous, Intermittent, High-concentration Oxygen Delivery
System) data element with a principal data element and three sub-
elements meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and to adopt the Oxygen Therapy
(Continuous, Intermittent, High-concentration Oxygen Delivery System)
data element as standardized patient assessment data for use in the SNF
QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Oxygen Therapy (Continuous, Intermittent,
High-concentration Oxygen Delivery System) data element.
    Comment: One commenter was supportive of collecting this data
element.
[[Page 38781]]
    Response: We thank the commenter for the support of the Oxygen
Therapy data element.
    Comment: One commenter noted concern around burden of completing
the Oxygen Therapy data element, in particular the additional
administrative burden because this data element adds sub-elements to an
existing MDS item. However, the commenter also stated their belief that
the Oxygen Therapy data element would provide a more accurate
reflection of residents' resource needs that could inform case-mix
payment methodology.
    Response: We appreciate the commenter's concern for burden on
clinical staff. The primary data element, Oxygen Therapy, is already
included in the MDS. Our clinical advisors and stakeholders have stated
that the type of oxygen support received by a patient--that is,
Continuous, Intermittent, High-concentration Oxygen Delivery System--
can be reasonably expected to be included in the medical record with
the indication for oxygen therapy overall. We contend that the addition
of sub-elements to the existing MDS data element will not require the
assessor to undertake an entirely new search within the medical record
for this information. Rather, the additional information required by
the sub-elements will be documented within or adjacent to information
on the primary data element. Therefore, the additional burden of data
collection related to the sub-elements is minimal, requiring only that
the assessor document in the MDS additional information that should be
readily available in a patient's medical record with the documentation
of the primary data element. We agree that assessment of Oxygen Therapy
received by patients in the SNF setting would provide important
information for care planning and resource use in SNFs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Oxygen Therapy (Intermittent,
Continuous, High-Concentration Oxygen Delivery System) data element as
standardized patient assessment data beginning with the FY 2022 SNF QRP
as proposed.
(d) Respiratory Treatment: Suctioning (Scheduled, As Needed)
    In the FY 2020 SNF PPS proposed rule (84 FR 17652 through 17653),
we proposed that the Suctioning (Scheduled, As needed) data element
meets the definition of standardized patient assessment data with
respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21065
through 21066), suctioning is a process used to clear secretions from
the airway when a person cannot clear those secretions on his or her
own. It is done by aspirating secretions through a catheter connected
to a suction source. Types of suctioning include oropharyngeal and
nasopharyngeal suctioning, nasotracheal suctioning, and suctioning
through an artificial airway such as a tracheostomy tube. Oropharyngeal
and nasopharyngeal suctioning are a key part of many patients' care
plans, both to prevent the accumulation of secretions than can lead to
aspiration pneumonias (a common condition in patients and residents
with inadequate gag reflexes), and to relieve obstructions from mucus
plugging during an acute or chronic respiratory infection, which often
lead to desaturations and increased respiratory effort. Suctioning can
be done on a scheduled basis if the patient is judged to clinically
benefit from regular interventions, or can be done as needed when
secretions become so prominent that gurgling or choking is noted, or a
sudden desaturation occurs from a mucus plug. As suctioning is
generally performed by a care provider rather than independently, this
intervention can be quite resource intensive if it occurs every hour,
for example, rather than once a shift. It also signifies an underlying
medical condition that prevents the patient from clearing his/her
secretions effectively (such as after a stroke, or during an acute
respiratory infection). Generally, suctioning is necessary to ensure
that the airway is clear of secretions which can inhibit successful
oxygenation of the individual. The intent of suctioning is to maintain
a patent airway, the loss of which can lead to death or complications
associated with hypoxia.
    The Suctioning (Scheduled, As needed) data element consists of a
principal data element, and two sub-elements: Scheduled; and As needed.
These sub-elements capture two types of suctioning. Scheduled indicates
suctioning based on a specific frequency, such as every hour; As needed
means suctioning only when indicated. If the assessor indicates that
the resident is receiving suctioning on the principal Suctioning data
element, the assessor would then indicate the frequency (for example,
Scheduled, As needed). The proposed data element is based on an item
currently in use in the MDS in SNFs which does not include our proposed
two sub-elements, as well as data elements tested in the PAC PRD that
focused on the frequency of suctioning required for patients with
tracheostomies (``Trach Tube with Suctioning: Specify most intensive
frequency of suctioning during stay [Every __hours]''). We proposed to
expand the existing Suctioning data element on the MDS to include sub-
elements for Scheduled and As Needed. For more information on the
Suctioning data element, we refer readers to the document titled
``Final Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Suctioning data element was first proposed as standardized
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR
21065 through 21066). In that proposed rule, we stated that the
proposal was informed by input we received on the Suctioning data
element currently included in the MDS in SNFs through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted from August 12 to September 12, 2016 expressed support
for this data element. The input noted the feasibility of this item in
PAC, and the relevance of this data element to facilitating care
coordination and supporting care transitions. We also stated that those
commenters had suggested that we examine the frequency of suctioning to
better understand the use of staff time, the impact on a patient or
resident's capacity to speak and swallow, and intensity of care
required. Based on these comments, we decided to add two sub-elements
(Scheduled and As needed) to the suctioning element. The proposed
Suctioning data element includes both the principal Suctioning data
element that is included on the MDS in SNFs and two sub-elements,
Scheduled and As needed. A summary report for the August 12 to
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of Suctioning (Scheduled, As
needed) as a standardized patient assessment data element. One
commenter objected to
[[Page 38782]]
``scheduled'' suctioning as a response option due to a clinical
practice guideline recommendation that suctioning should only be
performed when clinically indicated and not on a scheduled basis.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Suctioning data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Suctioning
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Suctioning
data element in the National Beta Test can be found in the document
titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Suctioning data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicited additional comments. General input on the
testing and item development process and concerns about burden were
received from stakeholders during this meeting and via email through
February 1, 2019. A summary of the public input received from the
November 27, 2018 stakeholder meeting titled ``Input on Standardized
Patient Assessment Data Elements (SPADEs) Received After November 27,
2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for suctioning,
stakeholder input, and strong test results, we proposed that the
Suctioning (Scheduled, As needed) data element with a principal data
element and two sub-elements meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Suctioning (Scheduled, As needed) data element as
standardized patient assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Suctioning (Scheduled, As needed) data
element.
    Comment: One commenter was supportive of collecting this data
element.
    Response: We thank the commenter for the support of the Suctioning
data element.
    Comment: One commenter requested that this data element also assess
the frequency of suctioning, as it can impact resource utilization and
potential medication changes in the plan of care.
    Response: We appreciate that the response options for this data
element may not fully capture impacts to resource utilization and care
plans. The Suctioning data element includes sub-elements to identify if
suctioning is performed on a ``Scheduled'' or ``As Needed'' basis, but
it does not directly assess the frequency of suctioning by, for
example, asking an assessor to specify how often suctioning is
scheduled. This data element differentiates between patients who only
occasionally need suctioning, and patients for whom assessment of
suctioning needs is a frequent and routine part of the care (that is,
where suctioning is performed on a schedule according to physician
instructions). In our work to identify standardized data elements, we
strived to balance the scope and level of detail of the data elements
against the potential burden placed on patients and providers, and we
believe that modifying the Suctioning data element to assess frequency
of suction would collect an overly-detailed and potentially burdensome
level of clinical information about a patient that is not necessary to
support quality measures, care planning, or care transitions.
Therefore, we will not be modifying the Suctioning data element to
assess the frequency of suctioning. However, we would like to clarify
that any standardized patient assessment data element is intended as a
minimum assessment and does not limit the ability of providers to
conduct a more comprehensive evaluation of a patient's situation to
identify the potential impacts on outcomes that the commenter
describes.
    Comment: One commenter noted concern around burden of completion of
the Suctioning data element, in particular the additional
administrative burden because this data element adds sub-elements to an
existing MDS item. However, the commenter also stated their belief that
the Suctioning data element would provide a more accurate reflection of
residents' resource needs that could inform case-mix payment
methodology.
    Response: We appreciate the commenter's concern for burden on
clinical staff. The primary data element, Suctioning, is already
included in the MDS. Our clinical advisors and stakeholders have stated
that the type of suctioning support received by a patient, that is,
Scheduled or As Needed, can be reasonably expected to be included in
the medical record with the indication for suctioning overall. We
contend that the addition of sub-elements to the existing MDS data
element will not require the assessor to undertake an entirely new
search within the medical record for this information. Rather, the
additional information required by the sub-elements will be documented
within or adjacent to information on the primary data element.
Therefore, the additional burden of data collection related to the sub-
elements is minimal, requiring only that the assessor document in the
MDS additional information that should be readily available in a
patient's medical record with the documentation of the primary data
element. We agree that assessment of Suctioning received by patients in
the SNF setting would provide important information for care planning
and resource use in SNFs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Suctioning (Scheduled, As
needed) data element as standardized patient assessment data beginning
with the FY 2022 SNF QRP as proposed.
[[Page 38783]]
(e) Respiratory Treatment: Tracheostomy Care
    In the FY 2020 SNF PPS proposed rule (84 FR 17653 through 17654),
we proposed that the Tracheostomy Care data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21066
through 21067), a tracheostomy provides an air passage to help a
patient or resident breathe when the usual route for breathing is
obstructed or impaired. Generally, in all of these cases, suctioning is
necessary to ensure that the tracheostomy is clear of secretions, which
can inhibit successful oxygenation of the individual. Often,
individuals with tracheostomies are also receiving supplemental
oxygenation. The presence of a tracheostomy, albeit permanent or
temporary, warrants careful monitoring and immediate intervention if
the tracheostomy becomes occluded or if the device used becomes
dislodged. While in rare cases the presence of a tracheostomy is not
associated with increased care demands (and in some of those instances,
the care of the ostomy is performed by the patient) in general the
presence of such as device is associated with increased patient risk,
and clinical care services will necessarily include close monitoring to
ensure that no life-threatening events occur as a result of the
tracheostomy. In addition, tracheostomy care, which primarily consists
of cleansing, dressing changes, and replacement of the tracheostomy
cannula (tube), is a critical part of the care plan. Regular cleansing
is important to prevent infection such as pneumonia, and to prevent any
occlusions with which there are risks for inadequate oxygenation.
    The proposed data element consists of the single Tracheostomy Care
data element. The proposed data element is currently in use in the MDS
in SNFs (``Tracheostomy care''). For more information on the
Tracheostomy Care data element, we refer readers to the document titled
``Final Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Tracheostomy Care data element was first proposed as
standardized patient assessment data in the FY 2018 SNF PPS proposed
rule (82 FR 21066 through 21067). In that proposed rule, we stated that
the proposal was informed by input we received on the Tracheostomy Care
data element through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted from August 12 to
September 12, 2016, supported this data element, noting the feasibility
of this item in PAC, and the relevance of this data element to
facilitating care coordination and supporting care transitions. A
summary report for the August 12 to September 12, 2016 public comment
period titled ``SPADE August 2016 Public Comment Summary Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
we received a few comments in support of the adoption of Tracheostomy
Care as a standardized patient assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Tracheostomy Care data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the
Tracheostomy Care data element to be feasible and reliable for use with
PAC patients and residents. More information about the performance of
the Tracheostomy Care data element in the National Beta Test can be
found in the document titled ``Final Specifications for SNF QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Tracheostomy Care data element, the TEP
supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for tracheostomy care,
stakeholder input, and strong test results, we proposed that the
Tracheostomy Care data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Tracheostomy Care data element as standardized patient
assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Tracheostomy Care data element.
    Comment: One commenter was supportive of collecting this data
element.
    Response: We thank the commenter for the support of the
Tracheostomy Care data element.
    Comment: One commenter noted the importance of determining if a
patient had a tracheostomy as it helps with risk adjustment and
identifying increased resource utilization, but recommended that the
SPADE be expanded to ask about the size of the tracheostomy and whether
the tracheostomy has a cuff or is fenestrated.
    Response: Risk adjustment determinations is an issue that we
continue to evaluate in all of our QRP programs. We will note this
issue for further analysis in our future work to
[[Page 38784]]
determine how the SPADEs will be used. With regard to the commenter's
request to expand the Tracheostomy Care SPADE to include more detail
about the type of tracheostomy, we do not believe that this level of
clinical detail is needed to fulfill the purposes of the SPADEs, which
are to support care coordination, care planning, and future quality
measures. We believe the broad indication that a patient is receiving
Tracheostomy Care will be sufficient for the purposes of
standardization and quality measurement, and that additional detail
would generate unnecessary burden.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Tracheostomy Care data element
as standardized patient assessment data beginning with the FY 2022 SNF
QRP as proposed.
(f) Respiratory Treatment: Non-Invasive Mechanical Ventilator (BiPAP,
CPAP)
    In the FY 2020 SNF PPS proposed rule (84 FR 17654 through 17655),
we proposed that the Non-invasive Mechanical Ventilator (Bilevel
Positive Airway Pressure [BiPAP], Continuous Positive Airway Pressure
[CPAP]) data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21067),
BiPAP and CPAP are respiratory support devices that prevent the airways
from closing by delivering slightly pressurized air via electronic
cycling throughout the breathing cycle (BiPAP) or through a mask
continuously (CPAP). Assessment of non-invasive mechanical ventilation
is important in care planning, as both CPAP and BiPAP are resource-
intensive (although less so than invasive mechanical ventilation) and
signify underlying medical conditions about the patient or resident who
requires the use of this intervention. Particularly when used in
settings of acute illness or progressive respiratory decline,
additional staff (for example, respiratory therapists) are required to
monitor and adjust the CPAP and BiPAP settings and the patient or
resident may require more nursing resources.
    The proposed data element, Non-invasive Mechanical Ventilator
(BiPAP, CPAP), consists of the principal Non-invasive Mechanical
Ventilator data element and two response option sub-elements: BiPAP and
CPAP. If the assessor indicates that the resident is receiving non-
invasive mechanical ventilation on the principal Non-invasive
Mechanical Ventilator data element, the assessor would then indicate
which type (for example, BiPAP, CPAP). Data elements that assess non-
invasive mechanical ventilation are currently included on LCDS for the
LTCH setting (``Non-invasive Ventilator (BiPAP, CPAP)''), and the MDS
for the SNF setting (``Non-invasive Mechanical Ventilator (BiPAP/
CPAP)''). We proposed to expand the existing BiPAP/CPAP data element on
the MDS, retaining and relabeling the BiPAP/CPAP data element to be
Non-invasive Mechanical Ventilator (BiPAP, CPAP), and adding two sub-
elements for BiPAP and CPAP. For more information on the Non-invasive
Mechanical Ventilator (BiPAP, CPAP) data element, we refer readers to
the document titled ``Final Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Non-invasive Mechanical Ventilator data element was first
proposed as standardized patient assessment data elements in the FY
2018 SNF PPS proposed rule (82 FR 21067). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted from August 12 to September 12, 2016
on a single data element, BiPAP/CPAP, that captures equivalent clinical
information but uses a different label than the data element currently
used in the MDS in SNFs and LCDS in LTCHs, expressed support for this
data element, noting the feasibility of these items in PAC, and the
relevance of this data element for facilitating care coordination and
supporting care transitions. In addition, we also stated that some
commenters supported separating out BiPAP and CPAP as distinct sub-
elements, as they are therapies used for different types of patients
and residents. A summary report for the August 12 to September 12, 2016
public comment period titled ``SPADE August 2016 Public Comment Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of Non-Invasive Mechanical
Ventilator (BiPAP, CPAP) as a standardized patient assessment data
element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Non-invasive Mechanical Ventilator data element was included in the
National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Non-invasive Mechanical Ventilator data element to be
feasible and reliable for use with PAC patients and residents. More
information about the performance of the Non-invasive Mechanical
Ventilator data element in the National Beta Test can be found in the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Non-invasive Mechanical Ventilator data
element, the TEP supported the assessment of the special services,
treatments, and interventions included in the National Beta Test with
respect to both admission and discharge. A summary of the September 17,
2018 TEP meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements
[[Page 38785]]
(SPADEs) Received After November 27, 2018 Stakeholder Meeting'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for non-invasive
mechanical ventilation, stakeholder input, and strong test results, we
proposed that the Non-invasive Mechanical Ventilator (BiPAP, CPAP) data
element with a principal data element and two sub-elements meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Non-invasive Mechanical
Ventilator (BiPAP, CPAP) data element as standardized patient
assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Non-invasive Mechanical Ventilator (BiPAP,
CPAP) data element.
    Comment: One commenter was supportive of collecting this data
element.
    Response: We thank the commenter for the support of the Non-
Invasive Mechanical Ventilator data element.
    Comment: One commenter noted concern around burden of completion of
the Non-Invasive Mechanical Ventilator data element, in particular the
additional administrative burden because this data element adds sub-
elements to an existing MDS item. However, the commenter also stated
their belief that the Non-Invasive Mechanical Ventilator data element
would provide a more accurate reflection of residents' resource needs
that could inform case-mix payment methodology.
    Response: We appreciate the commenter's concern on additional
administrative burden. The primary data element, Non-Invasive
Mechanical Ventilator, is already included in the MDS. Our clinical
advisors and stakeholders have stated that the type of ventilator
received by a patient--that is, CPAP or BiPAP--can be reasonably
expected to be included in the medical record with the indication for
ventilator overall. We contend that the addition of sub-elements to the
existing MDS data element will not require the assessor to undertake an
entirely new search within the medical record for this information.
Rather, the additional information required by the sub-elements will be
documented within or adjacent to information on the primary data
element. Therefore, the additional burden of data collection related to
the sub-elements is minimal, requiring only that the assessor document
in the MDS additional information that should be readily available in a
patient's medical record with the documentation of the primary data
element. We agree that assessment of non-mechanical ventilator services
received by patients in the SNF setting would provide important
information for care planning and resource use in SNFs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Non-invasive Mechanical
Ventilator (BiPAP, CPAP) data element as standardized patient
assessment data beginning with the FY 2022 SNF QRP as proposed.
(g) Respiratory Treatment: Invasive Mechanical Ventilator
    In the FY 2020 SNF PPS proposed rule (84 FR 17655 through 17656),
we proposed that the Invasive Mechanical Ventilator data element meets
the definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21067
through 21068), invasive mechanical ventilation includes ventilators
and respirators that ventilate the patient through a tube that extends
via the oral airway into the pulmonary region or through a surgical
opening directly into the trachea. Thus, assessment of invasive
mechanical ventilation is important in care planning and risk
mitigation. Ventilation in this manner is a resource-intensive therapy
associated with life-threatening conditions without which the patient
or resident would not survive. However, ventilator use has inherent
risks requiring close monitoring. Failure to adequately care for the
patient or resident who is ventilator dependent can lead to iatrogenic
events such as death, pneumonia, and sepsis. Mechanical ventilation
further signifies the complexity of the patient's underlying medical or
surgical condition. Of note, invasive mechanical ventilation is
associated with high daily and aggregate costs.\94\
---------------------------------------------------------------------------
    \94\ Wunsch, H., Linde-Zwirble, W.T., Angus, D.C., Hartman,
M.E., Milbrandt, E.B., & Kahn, J.M. (2010). ``The epidemiology of
mechanical ventilation use in the United States.'' Critical Care Med
38(10): 1947-1953.
---------------------------------------------------------------------------
    The proposed data element, Invasive Mechanical Ventilator, consists
of a single data element. Data elements that capture invasive
mechanical ventilation are currently in use in the MDS in SNFs and LCDS
in LTCHs. The MDS currently assesses invasive mechanical ventilation
with the Ventilator or Respirator data element. We proposed to rename
this data element in the MDS to be Invasive Mechanical Ventilator. For
more information on the Invasive Mechanical Ventilator data element, we
refer readers to the document titled ``Final Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Invasive Mechanical Ventilator data element was first proposed
as standardized patient assessment data in the FY 2018 SNF PPS proposed
rule (82 FR 21067 through 21068). In that proposed rule, we stated that
the proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website on
data elements that assess invasive ventilator use and weaning status
that were tested in the PAC PRD (``Ventilator--Weaning'' and
``Ventilator--Non-Weaning''). Input submitted from August 12 to
September 12, 2016 expressed support for this data element,
highlighting the importance of this information in supporting care
coordination and care transitions. We also stated that some commenters
had expressed concern about the appropriateness for standardization
given: The prevalence of ventilator weaning across PAC providers; the
timing of administration; how weaning is defined; and how weaning
status in particular relates to quality of care. These public comments
guided our decision to propose a single data element focused on current
use of invasive mechanical ventilation only, which does not attempt to
capture weaning status. A summary report for the August 12 to September
12, 2016 public comment period titled ``SPADE August 2016 Public
Comment Summary Report'' we received is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, a
few commenters supported the adoption of Invasive Mechanical Ventilator
as a standardized patient assessment data element. One commenter stated
that a
[[Page 38786]]
data element to indicate ``weaning'' is important because it indicates
higher resource utilization.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Invasive Mechanical Ventilator data element was included in the
National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Invasive Mechanical Ventilator data element to be
feasible and reliable for use with PAC patients and residents. More
information about the performance of the Invasive Mechanical Ventilator
data element in the National Beta Test can be found in the document
titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Invasive Mechanical Ventilator data element,
the TEP supported the assessment of the special services, treatments,
and interventions included in the National Beta Test with respect to
both admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for invasive mechanical
ventilation, stakeholder input, and strong test results, we proposed
that the Invasive Mechanical Ventilator data element that assesses the
use of an invasive mechanical ventilator meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Invasive Mechanical Ventilator data element as
standardized patient assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Invasive Mechanical Ventilator data element.
    Comment: One commenter was supportive of collecting this data
element.
    Response: We thank the commenter for the support of the Invasive
Mechanical Ventilator data element.
    Comment: One commenter was disappointed to see that this data
element only assesses whether or not a patient is on a mechanical
ventilator. The commenter urged CMS to consider collecting data to
track functional outcomes related to progress towards independence in
communication and swallowing.
    Response: We have attempted to balance the scope and level of
detail of the data elements against the potential burden placed on
patients and providers. We believe that assessing the use of an
invasive mechanical ventilator will be a useful point of information to
inform care planning and further assessment, such as related to
functional outcomes, as the commenter suggests, but we do not believe
it is necessary to track functional outcomes related to progress
towards independence in communication and swallowing as part of the
SPADEs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Invasive Mechanical Ventilator
data element as standardized patient assessment data beginning with the
FY 2022 SNF QRP as proposed.
(h) Intravenous (IV) Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other)
    In the FY 2020 SNF PPS proposed rule (84 FR 17656 through 17657),
we proposed that the IV Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other) data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21068
through 21069), when we proposed a similar data element related to IV
medications, IV medications are solutions of a specific medication (for
example, antibiotics, anticoagulants) administered directly into the
venous circulation via a syringe or intravenous catheter. IV
medications are administered via intravenous push, single,
intermittent, or continuous infusion through a catheter placed into the
vein. Further, IV medications are more resource intensive to administer
than oral medications, and signify a higher patient complexity (and
often higher severity of illness).
    The clinical indications for each of the sub-elements of the IV
Medications data element (Antibiotics, Anticoagulants, Vasoactive
Medications, and Other) are very different. IV antibiotics are used for
severe infections when the bioavailability of the oral form of the
medication would be inadequate to kill the pathogen or an oral form of
the medication does not exist. IV anticoagulants refer to anti-clotting
medications (that is, ``blood thinners''). IV anticoagulants are
commonly used for hospitalized patients who have deep venous
thrombosis, pulmonary embolism, or myocardial infarction, as well as
those undergoing interventional cardiac procedures. Vasoactive
medications refer to the IV administration of vasoactive drugs,
including vasopressors, vasodilators, and continuous medication for
pulmonary edema, which increase or decrease blood pressure or heart
rate. The indications, risks, and benefits of each of these classes of
IV medications are distinct, making it important to assess each
separately in PAC. Knowing whether or not patients and residents are
receiving IV medication and the type of medication provided by each PAC
provider will improve quality of care.
    The IV Medications (Antibiotics, Anticoagulants, Vasoactive
Medications, and Other) data element we proposed consists of a
principal data element (IV Medications) and four response option sub-
elements: Antibiotics, Anticoagulants, Vasoactive Medications, and
Other. The Vasoactive Medications sub-element was not proposed in the
FY 2018 SNF PPS proposed rule. We added the Vasoactive Medications sub-
element
[[Page 38787]]
to our proposal in order to harmonize the proposed IV Mediciations
element with the data currently collected in the LCDS.
    If the assessor indicates that the resident is receiving IV
medications on the principal IV Medications data element, the assessor
would then indicate which types of medications (for example,
Antibiotics, Anticoagulants, Vasoactive Medications, Other). An IV
Medications data element is currently in use on the MDS in SNFs and
there is a related data element in OASIS that collects information on
Intravenous and Infusion Therapies. We proposed to expand the existing
IV Medications data element in the MDS to include sub-elements for
Antibiotics, Anticoagulants, Vasoactive Medications, and Other. For
more information on the IV Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other) data element, we refer readers to the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    An IV Medications data element was first proposed as SPADEs in the
FY 2018 SNF PPS proposed rule (82 FR 21068 through 21069). In that
proposed rule, we stated that the proposal was informed by input we
received on Vasoactive Medications through a call for input published
on the CMS Measures Management System Blueprint website. Input
submitted from August 12 to September 12, 2016 supported this data
element with one noting the importance of this data element in
supporting care transitions. We also stated that those commenters had
criticized the need for collecting specifically Vasoactive Medications,
giving feedback that the data element was too narrowly focused. In
addition, public comment received indicated that the clinical
significance of vasoactive medications administration alone was not
high enough in PAC to merit mandated assessment, noting that related
and more useful information could be captured in an item that assessed
all IV medication use. A summary report for the August 12 to September
12, 2016 public comment period titled ``SPADE August 2016 Public
Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of Intravenous (IV) Medications
(Antibiotics, Anticoagulation, Other) as a standardized patient
assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
IV Medications data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the IV
Medications data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
IV Medications data element in the National Beta Test can be found in
the document titled ``Final Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the IV Medications data element, the TEP supported
the assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for IV medications,
stakeholder input, and strong test results, we proposed that the IV
Medications (Antibiotics, Anticoagulants, Vasoactive Medications,
Other) data element with a principal data element and four sub-elements
meets the definition of standardized patient assessment data with
respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and to adopt the IV Medications
(Antibiotics, Anticoagulants, Vasoactive Medications, Other) data
element as standardized patient assessment data for use in the SNF QRP.
    Commenters submitted the following comment related to the proposed
rule's discussion of the IV Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other) data element.
    Comment: One commenter noted concern around burden of completion of
the IV Medication data element, in particular the additional
administrative burden because this data element adds sub-elements to an
existing MDS item. However, the commenter also stated their belief that
IV Medication data element would provide a more accurate reflection of
residents' resource needs that could inform case-mix payment
methodology.
    Response: We appreciate the commenter's concern for administrative
burden. The primary data element, IV Medications, is already included
in the MDS. Our clinical advisors and stakeholders have stated that the
type of IV Medications received by a patient can be reasonably expected
to be included in the medical record with the indication for IV
medications overall. We contend that the addition of sub-elements to
the existing MDS data element will not require the assessor to
undertake an entirely new search within the medical record for this
information. Rather, the additional information required by the sub-
elements will be documented within or adjacent to information on the
primary data element. Therefore, the additional burden of data
collection related to the sub-elements is minimal, requiring only that
the assessor document in the MDS
[[Page 38788]]
additional information that should be readily available in a patient's
medical record with the documentation of the primary data element. We
agree that assessment of IV medications received by patients in the SNF
setting would provide important information for care planning and
resource use in SNFs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the IV Medications (Antibiotics,
Anticoagulants, Vasoactive Medications, Other) data element as
standardized patient assessment data beginning with the FY 2022 SNF QRP
as proposed.
(i) Transfusions
    In the FY 2020 SNF PPS proposed rule (84 FR 17657 through 17658),
we proposed that the Transfusions data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21069),
transfusion refers to introducing blood or blood products into the
circulatory system of a person. Blood transfusions are based on
specific protocols, with multiple safety checks and monitoring required
during and after the infusion in case of adverse events. Coordination
with the provider's blood bank is necessary, as well as documentation
by clinical staff to ensure compliance with regulatory requirements. In
addition, the need for transfusions signifies underlying patient
complexity that is likely to require care coordination and patient
monitoring, and impacts planning for transitions of care, as
transfusions are not performed by all PAC providers.
    The proposed data element consists of the single Transfusions data
element. A data element on transfusion is currently in use in the MDS
in SNFs (``Transfusions'') and a data element tested in the PAC PRD
(``Blood Transfusions'') was found feasible for use in each of the four
PAC settings. For more information on the Transfusions data element, we
refer readers to the document titled ``Final Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of Transfusions as a
standardized patient assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Transfusions data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the
Transfusions data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Transfusions data element in the National Beta Test can be found in the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Transfusions data element, the TEP supported
the assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for transfusions,
stakeholder input, and strong test results, we proposed that the
Transfusions data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Transfusions data element as standardized patient assessment data
for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Transfusions data element.
    Comment: One commenter applauded CMS for including the Transfusion
data element noting that it will provide information on care planning,
clinical decision making, patient safety, care transitions, and
resource use in SNFs and will contribute to higher quality and
coordinated care for patients who rely on these life-saving treatments.
    Response: We thank the commenter for the support. We selected the
Transfusions data element for proposal as standardized data in part
because of the attributes that the commenters noted.
    Comment: One commenter was concerned that SNFs will not have the
resources needed to provide patients with access to blood transfusions
and requested that CMS consider whether payments to SNFs are adequate
to cover the cost of this resource intensive, specialized service.
    Response: At this time, this item will not be used for any payment
purposes, and thus we are not able to comment on cost of this service.
We wish to clarify that the Transfusion SPADE collects information on
the complexity of the patient and resources the patient requires. This
SPADE is not intended to measure the ability of a SNF to provide in-
house transfusions, only to capture the services a given resident may
be receiving. We are not evaluating the costs that SNFs incur when
providing blood transfusions. Further, for patients who require
services related to blood transfusions, information collected by this
data element is a part of common clinical workflow, and thus, we
believe that burden on resource intensity would not be affected by the
standardization of this data element.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Transfusions data element as
standardized patient assessment data
[[Page 38789]]
beginning with the FY 2022 SNF QRP as proposed.
(j) Dialysis (Hemodialysis, Peritoneal Dialysis)
    In the FY 2020 SNF PPS proposed rule (84 FR 17658 through 17659),
we proposed that the Dialysis (Hemodialysis, Peritoneal dialysis) data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21070),
dialysis is a treatment primarily used to provide replacement for lost
kidney function. Both forms of dialysis (hemodialysis and peritoneal
dialysis) are resource intensive, not only during the actual dialysis
process but before, during, and following. Patients and residents who
need and undergo dialysis procedures are at high risk for physiologic
and hemodynamic instability from fluid shifts and electrolyte
disturbances, as well as infections that can lead to sepsis. Further,
patients or residents receiving hemodialysis are often transported to a
different facility, or at a minimum, to a different location in the
same facility for treatment. Close monitoring for fluid shifts, blood
pressure abnormalities, and other adverse effects is required prior to,
during, and following each dialysis session. Nursing staff typically
perform peritoneal dialysis at the bedside, and as with hemodialysis,
close monitoring is required.
    The proposed data element, Dialysis (Hemodialysis, Peritoneal
dialysis) consists of the principal Dialysis data element and two
response option sub-elements: Hemodialysis and Peritoneal dialysis. If
the assessor indicates that the resident is receiving dialysis on the
principal Dialysis data element, the assessor would then indicate which
type (Hemodialysis or Peritoneal dialysis). Dialysis data elements are
currently included on the MDS in SNFs and the LCDS in LTCHs and assess
the overall use of dialysis. We proposed to expand the existing
Dialysis data element in the MDS to include sub-elements for
Hemodialysis and Peritoneal dialysis.
    As the result of public feedback described below, we proposed a
data element that includes the principal Dialysis data element and two
sub-elements (Hemodialysis and Peritoneal dialysis). For more
information on the Dialysis data elements, we refer readers to the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Dialysis data element was first proposed as standardized
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR
21070). In that proposed rule, we stated that the proposal was informed
by input we received on a singular Hemodialysis data element through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted from August 12 to September 12, 2016
supported the assessment of hemodialysis and recommended that the data
element be expanded to include peritoneal dialysis. We also stated that
those commenters had supported the singular Hemodialysis data element,
noting the relevance of this information for sharing across the care
continuum to facilitate care coordination and care transitions, the
potential for this data element to be used to improve quality, and the
feasibility for use in PAC. In addition, we received comment that the
item would be useful in improving patient and resident transitions of
care. We also noted that several commenters had stated that peritoneal
dialysis should be included in a standardized data element on dialysis
and recommended collecting information on peritoneal dialysis in
addition to hemodialysis. The rationale for including peritoneal
dialysis from commenters included the fact that patients and residents
receiving peritoneal dialysis will have different needs at post-acute
discharge compared to those receiving hemodialysis or not having any
dialysis. Based on these comments, the Hemodialysis data element was
expanded to include a principal Dialysis data element and two sub-
elements, Hemodialysis and Peritoneal dialysis. We proposed the version
of the Dialysis element that includes two types of dialysis. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of Dialysis (Hemodialysis,
Peritoneal dialysis) as a standardized patient assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Dialysis data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Dialysis
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Dialysis data
element in the National Beta Test can be found in the document titled
``Final Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although they did not
specifically discuss the Dialysis data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-
[[Page 38790]]
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for dialysis,
stakeholder input, and strong test results, we proposed that the
Dialysis (Hemodialysis, Peritoneal dialysis) data element with a
principal data element and two sub-elements meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Dialysis (Hemodialysis, Peritoneal dialysis) data
element as standardized patient assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Dialysis (Hemodialysis, Peritoneal dialysis)
data element. A discussion of these comments, along with our responses,
appears below.
    Comment: One commenter noted concern around burden of completion of
the Dialysis data element, in particular the additional administrative
burden because this data element adds sub-elements to an existing MDS
item. However, the commenter also stated their belief that the Dialysis
data element would provide a more accurate reflection of residents'
resource needs that could inform case-mix payment methodology.
    Response: We appreciate the commenter's concern for additional
administrative burden. The primary data element, Dialysis, is already
included in the MDS. Our clinical advisors and stakeholders have stated
that the type of dialysis received by a patient--that is, Hemodialysis
or Peritoneal Dialysis--can be reasonably expected to be included in
the medical record with the indication for dialysis overall. We contend
that the addition of sub-elements to the existing MDS data element will
not require the assessor to undertake an entirely new search within the
medical record for this information. Rather, the additional information
required by the sub-elements will be documented within or adjacent to
information on the primary data element. Therefore, the additional
burden of data collection related to the sub-elements is minimal,
requiring only that the assessor document in the MDS additional
information that should be readily available in a patient's medical
record with the documentation of the primary data element. We agree
that assessment of dialysis services received by patients in the SNF
setting would provide important information for care planning and
resource use in SNFs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Dialysis (Hemodialysis,
Peritoneal dialysis) data element as standardized patient assessment
data beginning with the FY 2022 SNF QRP as proposed.
(k) Intravenous (IV) Access (Peripheral IV, Midline, Central line)
    In the FY 2020 SNF PPS proposed rule (84 FR 17659 through 17660),
we proposed that the IV Access (Peripheral IV, Midline, Central line)
data element meets the definition of standardized patient assessment
data with respect to special services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21070
through 21071), patients or residents with central lines, including
those peripherally inserted or who have subcutaneous central line
``port'' access, always require vigilant nursing care to keep patency
of the lines and ensure that such invasive lines remain free from any
potentially life-threatening events such as infection, air embolism, or
bleeding from an open lumen. Clinically complex patients and residents
are likely to be receiving medications or nutrition intravenously. The
sub-elements included in the IV Access data elements distinguish
between peripheral access and different types of central access. The
rationale for distinguishing between a peripheral IV and central IV
access is that central lines confer higher risks associated with life-
threatening events such as pulmonary embolism, infection, and bleeding.
    The proposed data element, IV Access (Peripheral IV, Midline,
Central line), consists of the principal IV Access data element and
three response option sub-elements: Peripheral IV, Midline, and Central
line. The proposed IV Access data element is not currently included on
any of the PAC assessment instruments. For more information on the IV
Access (Peripheral IV, Midline, Central line) data element, we refer
readers to the document titled ``Final Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The IV Access data element was first proposed as standardized
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR
21070 through 21071). In that proposed rule, we stated that the
proposal was informed by input we received on one of the PAC PRD data
elements, Central Line Management, a type of IV access, through a call
for input published on the CMS Measures Management System Blueprint
website. Input submitted from August 12 to September 12, 2016 supported
the assessment of central line management and recommended that the data
element be broadened to also include other types of IV access. Several
commenters noted feasibility and importance of facilitating care
coordination and care transitions. However, a few commenters
recommended that the definition of this data element be broadened to
include peripherally inserted central catheters (``PICC lines'') and
midline IVs. Based on public comment feedback and in consultation with
expert input, described below, we created an overarching IV Access data
element with sub-elements for other types of IV access in addition to
central lines (that is, peripheral IV and midline). This expanded
version of IV Access is the data element being proposed. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of the IV Access (Peripheral IV,
Midline, Central line, Other) as a standardized patient assessment data
element, with one commenter encouraging clear guidance in the Resident
Assessment Instrument User Manual to distinguish between coding
instructions for this data element and those for other data elements on
IV treatments.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
IV Access data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the IV Access
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the IV Access data
element in the National Beta Test can be found in the document titled
``Final Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/
Medicare/Quality-
[[Page 38791]]
Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the IV Access data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for IV access,
stakeholder input, and strong test results, we proposed that the IV
access (Peripheral IV, Midline, Central line) data element with a
principal data element and three sub-elements meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the IV Access (Peripheral IV, Midline, Central line)
data element as standardized patient assessment data for use in the SNF
QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the IV Access (Peripheral IV, Midline, Central
line) data element.
    Comment: One commenter noted concern around burden of completion of
the IV Access data element, in particular the additional administrative
burden because this data element adds sub-elements to an existing MDS
item. However, the commenter also stated their belief that IV Access
data element would provide a more accurate reflection of residents'
resource needs that could inform case-mix payment methodology.
    Response: We appreciate the commenter's concern for additional
administrative burden. The primary data element, IV Access, is already
included in the MDS. Our clinical advisors and stakeholders have stated
that the type of IV access received by a patient can be reasonably
expected to be either plainly apparent or included in the medical
record at the same place as the indication for IV access overall. We
contend that the addition of sub-elements to the existing MDS data
element will not require the assessor to undertake an entirely new
search within the medical record for this information. Rather, the
additional information required by the sub-elements will be documented
within or adjacent to information on the primary data element.
Therefore, the additional burden of data collection related to the sub-
elements is minimal, requiring only that the assessor document in the
MDS additional information that should be readily available in a
patient's medical record with the documentation of the primary data
element. We agree that assessment of IV access for patients in the SNF
setting would provide important information for care planning and
resource use in SNFs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the IV Access (Peripheral IV,
Midline, Central line) data element as standardized patient assessment
data beginning with the FY 2022 SNF QRP as proposed.
(l) Nutritional Approach: Parenteral/IV Feeding
    In the FY 2020 SNF PPS proposed rule (84 FR 17660 through 17661),
we proposed that the Parenteral/IV Feeding data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21071
through 21072), parenteral nutrition/IV feeding refers to a patient or
resident being fed intravenously using an infusion pump, bypassing the
usual process of eating and digestion. The need for IV/parenteral
feeding indicates a clinical complexity that prevents the patient or
resident from meeting his or her nutritional needs enterally, and is
more resource intensive than other forms of nutrition, as it often
requires monitoring of blood chemistries and the maintenance of a
central line. Therefore, assessing a patient's or resident's need for
parenteral feeding is important for care planning and resource use. In
addition to the risks associated with central and peripheral
intravenous access, total parenteral nutrition is associated with
significant risks such as air embolism and sepsis.
    The proposed data element consists of the single Parenteral/IV
Feeding data element. The proposed Parenteral/IV Feeding data element
is currently in use in the MDS in SNFs, and equivalent or related data
elements are in use in the LCDS, IRF-PAI, and OASIS. For more
information on the Parenteral/IV Feeding data element, we refer readers
to the document titled ``Final Specifications for SNF QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Parenteral/IV Feeding data element was first proposed as a
SPADE in the FY 2018 SNF PPS proposed rule (82 FR 21071 through 21072).
In that proposed rule, we stated that the proposal was informed by
input we received on Total Parenteral Nutrition (an item with nearly
the same meaning as the proposed data element, but with the label used
in the PAC PRD) through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted from August 12 to
September 12, 2016 supported this data element, noting its relevance to
facilitating care coordination and supporting care transitions. After
the public comment period, the Total Parenteral Nutrition data element
was renamed Parenteral/IV Feeding, to be consistent with how this data
element is referred to in the MDS in SNFs. A summary report for the
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment Summary Report'' is available at https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Post-Acute-Care-Quality-
[[Page 38792]]
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of the Parenteral/IV Feeding as
a standardized patient assessment data element, with one requesting
``universal'' guidance for coding, which would be clearly defined and
more broadly applicable to patients and residents in all PAC settings.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Parenteral/IV Feeding data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Parenteral/IV Feeding data element to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the Parenteral/IV Feeding data element in the
National Beta Test can be found in the document titled ``Final
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Parenteral/IV Feeding data element, the TEP
supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for parenteral/IV
feeding, stakeholder input, and strong test results, we proposed that
the Parenteral/IV Feeding data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Parenteral/IV Feeding data element as standardized
patient assessment data for use in the SNF QRP.
    A commenter submitted the following comment related to the proposed
rule's discussion of the Parenteral/IV Feeding data element.
    Comment: One commenter was supportive of collecting this data
element but noted that it should not be a substitute for capturing
information related to swallowing which reflects additional patient
complexity and resource use.
    Response: We thank the commenter for their support and appreciate
the concerns raised. We agree that the Parenteral/IV Feeding SPADE
should not be used as a substitute for an assessment of a patient's
swallowing function. The proposed SPADEs are not intended to replace
comprehensive clinical evaluation and in no way preclude providers from
conducting further patient evaluation or assessments in their settings
as they believe are necessary and useful. We agree that information
related to swallowing can capture patient complexity, but we also note
that Parenteral/IV Feeding data element captures a different construct.
That is, the Parenteral/IV Feeding data element captures a patient's
need to receive calories and nutrients intravenously, while an
assessment of swallowing would capture a patient's functional ability
to safely consume food orally for digestion in their gastrointestinal
tract.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Parenteral/IV Feeding data
element as standardized patient assessment data beginning with the FY
2022 SNF QRP as proposed.
(m) Nutritional Approach: Feeding Tube
    In the FY 2020 SNF PPS proposed rule (84 FR 17661 through 17662),
we proposed that the Feeding Tube data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21072),
the majority of patients admitted to acute care hospitals experience
deterioration of their nutritional status during their hospital stay,
making assessment of nutritional status and method of feeding if unable
to eat orally very important in PAC. A feeding tube can be inserted
through the nose or the skin on the abdomen to deliver liquid nutrition
into the stomach or small intestine. Feeding tubes are resource
intensive and, therefore, are important to assess for care planning and
resource use. Patients with severe malnutrition are at higher risk for
a variety of complications.\95\ In PAC settings, there are a variety of
reasons that patients and residents may not be able to eat orally
(including clinical or cognitive status).
---------------------------------------------------------------------------
    \95\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The
link between nutritional status and clinical outcome: can
nutritional intervention modify it?'' Am J of Clinical Nutrition,
47(2): 352-356.
---------------------------------------------------------------------------
    The proposed data element consists of the single Feeding Tube data
element. The Feeding Tube data element is currently included in the MDS
for SNFs, and in the OASIS for HHAs, where it is labeled Enteral
Nutrition. A related data element, collected in the IRF-PAI for IRFs
(``Tube/Parenteral Feeding''), assesses use of both feeding tubes and
parenteral nutrition. For more information on the Feeding Tube data
element, we refer readers to the document titled ``Final Specifications
for SNF QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Feeding Tube data element was first proposed as a SPADE in the
FY 2018 SNF PPS proposed rule (82 FR 21072). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input published on the CMS Measures Management System
Blueprint website.
[[Page 38793]]
Input submitted from August 12 to September 12, 2016 on an Enteral
Nutrition data element (the Enteral Nutrition data item is the same as
the data element we proposed, but is used in the OASIS under a
different name) supported the data element, noting the importance of
assessing enteral nutrition status for facilitating care coordination
and care transitions. After the public comment period, the Enteral
Nutrition data element used in public comment was renamed Feeding Tube,
indicating the presence of an assistive device. A summary report for
the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment Summary Report'' is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of the Feeding Tube as a
standardized patient assessment data element. Another commenter
recommended that the term ``enteral feeding'' be used instead of
``feeding tube.''
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Feeding Tube data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Feeding
Tube data element to be feasible and reliable for use with PAC patients
and residents. More information about the performance of the Feeding
Tube data element in the National Beta Test can be found in the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Feeding Tube data element, the TEP supported
the assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for feeding tubes,
stakeholder input, and strong test results, we proposed that the
Feeding Tube data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Feeding Tube data element as standardized patient assessment data
for use in the SNF QRP.
    A commenter submitted the following comment related to the proposed
rule's discussion of the Feeding Tube data element.
    Comment: One commenter noted that in addition to identifying if the
patient is on a feeding tube or not, it would be important to assess
the patient's progression towards oral feeding within this data
element, as this impacts the tube feeding regimen.
    Response: We agree that the progression to oral feeding is
important for care planning and transfer, but we do not believe that
standardizing the collection of this information would be useful for
risk adjustment or the development of quality measures, which were
considerations in the selection of the SPADEs. At this time, we are
finalizing a singular Feeding Tube SPADE, which assesses the
nutritional approach only and does not capture the patient's prognosis
with regard to oral feeding. We wish to clarify that the proposed
SPADEs are not intended to replace comprehensive clinical evaluation
and in no way preclude providers from conducting further patient
evaluation or assessments in their settings as they believe are
necessary and useful. We will take this recommendation into
consideration in future work on standardized data elements.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Feeding Tube data element as
standardized patient assessment data beginning with the FY 2022 SNF QRP
as proposed.
(n) Nutritional Approach: Mechanically Altered Diet
    In the FY 2020 SNF PPS proposed rule (84 FR 17662 through 17663),
we proposed that the Mechanically Altered Diet data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21072
through 21073), the Mechanically Altered Diet data element refers to
food that has been altered to make it easier for the patient or
resident to chew and swallow, and this type of diet is used for
patients and residents who have difficulty performing these functions.
Patients with severe malnutrition are at higher risk for a variety of
complications.\96\
---------------------------------------------------------------------------
    \96\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The
link between nutritional status and clinical outcome: can
nutritional intervention modify it?'' Am J of Clinical Nutrition,
47(2): 352-356.
---------------------------------------------------------------------------
    In PAC settings, there are a variety of reasons that patients and
residents may have impairments related to oral feedings, including
clinical or cognitive status. The provision of a mechanically altered
diet may be resource intensive, and can signal difficulties associated
with swallowing/eating safety, including dysphagia. In other cases, it
signifies the type of altered food source, such as ground or puree that
will enable the safe and thorough ingestion of nutritional substances
and ensure safe and adequate delivery of nourishment to the patient.
Often, patients and residents on mechanically altered diets also
require additional nursing supports, such as individual feeding or
direct observation, to ensure the safe consumption of the food product.
Assessing whether a patient or resident requires a mechanically altered
diet is
[[Page 38794]]
therefore important for care planning and resource identification.
    The proposed data element consists of the single Mechanically
Altered Diet data element. The proposed data element is currently
included on the MDS for SNFs. A related data element (``Modified food
consistency/supervision'') is currently included on the IRF-PAI for
IRFs. Another related data element is included in the OASIS for HHAs
that collects information about independent eating that requires ``a
liquid, pureed or ground meat diet.'' For more information on the
Mechanically Altered Diet data element, we refer readers to the
document titled ``Final Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Mechanically Altered Diet data element was first proposed as
standardized patient assessment data in the FY 2018 SNF PPS proposed
rule (82 FR 21072 through 21073).
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported the adoption of the Mechanically Altered Diet
as a standardized patient assessment data element, with one requesting
``universal'' guidance for coding, which would be clearly defined and
more broadly applicable to patients and residents in all PAC settings.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Mechanically Altered Diet data element was included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Mechanically Altered Diet data element to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the Mechanically Altered Diet data element in
the National Beta Test can be found in the document titled ``Final
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Mechanically Altered Diet data element, the
TEP supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for mechanically
altered diet, stakeholder input, and strong test results, we proposed
that the Mechanically Altered Diet data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Mechanically Altered Diet data element as
standardized patient assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Mechanically Altered Diet data element.
    Comment: One commenter was supportive of collecting this data
element.
    Response: We thank the commenter for their support of the
Mechanically Altered Diet data element.
    Comment: One commenter was concerned that this data element does
not capture clinical complexity and does not provide any insight into
resource allocation because it only measures whether the patient needs
a mechanically altered diet and not, for example, the extent of help a
patient needs in consuming his or her meal.
    Response: We believe that assessing patients' needs for
mechanically altered diets captures one piece of information about
clinical complexity and resource allocation. That is, patients with
this special nutritional requirement may require additional nutritional
planning services, special meals, and staff to ensure that meals are
prepared and served in the way the patient needs. Additional factors
that would affect resource allocation, such as those noted by the
commenter, are not captured by this data element. We have decided not
to alter the SPADE as proposed in order to balance the scope and level
of detail of the data elements against the potential burden placed on
providers who must complete the assessment. We will take this
suggestion into consideration in future refinement of the clinical
SPADEs.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Mechanically Altered Diet data
element as standardized patient assessment data beginning with the FY
2022 SNF QRP as proposed.
(o) Nutritional Approach: Therapeutic Diet
    In the FY 2020 SNF PPS proposed rule (84 FR 17663), we proposed
that the Therapeutic Diet data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21073), a
therapeutic diet refers to meals planned to increase, decrease, or
eliminate specific foods or nutrients in a patient's or resident's
diet, such as a low-salt diet, for the purpose of treating a medical
condition. The use of therapeutic diets among patients and residents in
PAC provides insight on the clinical complexity of these patients and
residents and their multiple comorbidities. Therapeutic diets are less
resource intensive from the bedside nursing perspective, but do signify
one or more underlying clinical conditions that preclude the patient
from eating a regular diet. The communication among PAC providers about
whether a patient is receiving a particular therapeutic diet
[[Page 38795]]
is critical to ensure safe transitions of care.
    The proposed data element consists of the single Therapeutic Diet
data element. This data element is currently in use in the MDS in SNFs.
For more information on the Therapeutic Diet data element, we refer
readers to the document titled ``Final Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Therapeutic Diet data element was first proposed as
standardized patient assessment data in the FY 2018 SNF PPS proposed
rule (82 FR 21073). In response to our proposal in the FY 2018 SNF PPS
proposed rule, commenters supported the adoption of the Therapeutic
Diet as a standardized patient assessment data element. Some commenters
stated that the coding instructions should be clear and more broadly
applicable to patients and residents in all PAC settings. Other
commenters suggested that the definition of Therapeutic Diet should be
aligned with the Academy of Nutrition and Dietetics' definition, with
one stating that ``medically altered diet'' should be added to the
nutritional data elements.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Therapeutic Diet data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the
Therapeutic Diet data element to be feasible and reliable for use with
PAC patients and residents. More information about the performance of
the Therapeutic Diet data element in the National Beta Test can be
found in the document titled ``Final Specifications for SNF QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Therapeutic Diet data element, the TEP
supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for therapeutic diet,
stakeholder input, and strong test results, we proposed that the
Therapeutic Diet data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Therapeutic data element as standardized patient assessment
data for use in the SNF QRP.
    A commenter submitted the following comment related to the proposed
rule's discussion of the Therapeutic Diet data element.
    Comment: One commenter was supportive of collecting this data
element.
    Response: We thank the commenter for their support of the
Therapeutic Diet data element.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Therapeutic Diet data element
as standardized patient assessment data beginning with the FY 2022 SNF
QRP as proposed.
(p) High-Risk Drug Classes: Use and Indication
    In the FY 2020 SNF PPS proposed rule (84 FR 17663 through 17665),
we proposed that the High-Risk Drug Classes: Use and Indication data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
    Most patients and residents receiving PAC services depend on short-
and long-term medications to manage their medical conditions. However,
as a treatment, medications are not without risk; medications are in
fact a leading cause of adverse events. A study by the U.S. Department
of Health and Human Services found that 31 percent of adverse events
that occurred in 2008 among hospitalized Medicare beneficiaries were
related to medication.\97\ Moreover, changes in a patient's condition,
medications, and transitions between care settings put patients and
residents at risk of medication errors and adverse drug events (ADEs).
ADEs may be caused by medication errors such as drug omissions, errors
in dosage, and errors in dosing frequency.\98\
---------------------------------------------------------------------------
    \97\ U.S. Department of Health and Human Services. Office of
Inspector General. Daniel R. Levinson. Adverse Events in Hospitals:
National Incidence Among Medicare Beneficiaries. OEI-06-09-00090.
November 2010.
    \98\ Boockvar KS, Liu S, Goldstein N, Nebeker J, Siu A, Fried T.
Prescribing discrepancies likely to cause adverse drug events after
patient transfer. Qual Saf Health Care. 2009;18(1):32-6.
---------------------------------------------------------------------------
    ADEs are known to occur across different types of healthcare
settings. For example, the incidence of ADEs in the outpatient setting
has been estimated at 1.15 ADEs per 100 person-months,\99\ while the
rate of ADEs in the long-term care setting is approximately 9.80 ADEs
per 100 resident-months.\100\ In the hospital setting, the incidence
has been estimated at 15 ADEs per 100 admissions.\101\ In addition,
approximately half of all hospital-related medication errors and 20
percent of ADEs occur during transitions within, admission to, transfer
to, or discharge
[[Page 38796]]
from a hospital.102 103 104 ADEs are more common among older
adults, who make up most patients receiving PAC services. The rate of
emergency department visits for ADEs is three times higher among adults
65 years of age and older compared to that among those younger than age
65.\105\
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    \99\ Gandhi TK, Seger AC, Overhage JM, et al. Outpatient adverse
drug events identified by screening electronic health records. J
Patient Saf 2010;6:91-6.doi:10.1097/PTS.0b013e3181dcae06.
    \100\ Gurwitz JH, Field TS, Judge J, Rochon P, Harrold LR,
Cadoret C, et al. The incidence of adverse drug events in two large
academic long-term care facilities. Am J Med. 2005; 118(3):2518. Epub 2005/03/05. https://doi.org/10.1016/j.amjmed.2004.09.018 PMID: 15745723.
    \101\ Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL, Yoon
C, Matheny ME, Bates DW. Occurrence of adverse, often preventable,
events in community hospitals involving nephrotoxic drugs or those
excreted by the kidney. Kidney Int. 2009; 76:1192-1198. [PubMed:
19759525].
    \102\ Barnsteiner JH. Medication reconciliation: transfer of
medication information across settings-keeping it free from error. J
Infus Nurs. 2005;28(2 Suppl):31-36.
    \103\ Rozich J, Roger, R. Medication safety: One organization's
approach to the challenge. Journal of Clinical Outcomes Management.
2001(8):27-34.
    \104\ Gleason KM, Groszek JM, Sullivan C, Rooney D, Barnard C,
Noskin GA. Reconciliation of discrepancies in medication histories
and admission orders of newly hospitalized patients. Am J Health
Syst Pharm. 2004;61(16):1689-1695.
    \105\ Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ,
Budnitz DS. US emergency department visits for outpatient adverse
drug events, 2013-2014. JAMA. doi: 10.1001/jama.2016.16201.
---------------------------------------------------------------------------
    Understanding the types of medication a patient is taking and the
reason for its use are key facets of a patient's treatment with respect
to medication. Some classes of drugs are associated with more risk than
others.\106\ We proposed one High-Risk Drug Class data element with six
sub-elements. The response options that correspond to the six
medication classes are: Anticoagulants; antiplatelets; hypoglycemics
(including insulin); opioids; antipsychotics; and antibiotics. These
drug classes are high-risk due to the adverse effects that may result
from use. In particular: Bleeding risk is associated with
anticoagulants and antiplatelets; 107 108 fluid retention,
heart failure, and lactic acidosis are associated with hypoglycemics;
\109\ misuse is associated with opioids; \110\ fractures and strokes
are associated with antipsychotics; 111 112 and various
adverse events, such as central nervous systems effects and
gastrointestinal intolerance, are associated with antimicrobials,\113\
the larger category of medications that include antibiotics. Moreover,
some medications in five of the six drug classes included in this data
element are included in the 2019 Updated Beers Criteria[supreg] list as
potentially inappropriate medications for use in older adults.\114\
Finally, although a complete medication list should record several
important attributes of each medication (for example, dosage, route,
stop date), recording an indication for the drug is of crucial
importance.\115\
---------------------------------------------------------------------------
    \106\ Ibid.
    \107\ Shoeb M, Fang MC. Assessing bleeding risk in patients
taking anticoagulants. J Thromb Thrombolysis. 2013;35(3):312-319.
doi: 10.1007/s11239-013-0899-7.
    \108\ Melkonian M, Jarzebowski W, Pautas E. Bleeding risk of
antiplatelet drugs compared with oral anticoagulants in older
patients with atrial fibrillation: A systematic review and
meta[hyphen]analysis. J Thromb Haemost. 2017;15:1500-1510. DOI:
10.1111/jth.13697.
    \109\ Hamnvik OP, McMahon GT. Balancing Risk and Benefit with
Oral Hypoglycemic Drugs. The Mount Sinai journal of medicine, New
York. 2009; 76:234-243.
    \110\ Naples JG, Gellad WF, Hanlon JT. The Role of Opioid
Analgesics in Geriatric Pain Management. Clin Geriatr Med. 2016;32
(4):725-735.
    \111\ Rigler SK, Shireman TI, Cook-Wiens GJ, Ellerbeck EF,
Whittle JC, Mehr DR, Mahnken JD. Fracture risk in nursing home
residents initiating antipsychotic medications. J Am Geriatr Soc.
2013; 61(5):715-722. [PubMed: 23590366].
    \112\ Wang S, Linkletter C, Dore D et al. Age, antipsychotics,
and the risk of ischemic stroke in the Veterans Health
Administration. Stroke 2012;43:28-31. doi:10.1161/
STROKEAHA.111.617191.
    \113\ Faulkner CM, Cox HL, Williamson JC. Unique aspects of
antimicrobial use in older adults. Clin Infect Dis. 2005;40(7):997-
1004.
    \114\ American Geriatrics Society 2019 Beers Criteria Update
Expert Panel. American Geriatrics Society 2019 Updated Beers
Criteria for Potentially Inappropriate Medication Use in Older
Adults. J Am Geriatr Soc 2019; 00:1-21. DOI: 10.1111/jgs.15767.
    \115\ Li Y, Salmasian H, Harpaz R, Chase H, Friedman C.
Determining the reasons for medication prescriptions in the EHR
using knowledge and natural language processing. AMIA Annu Symp
Proc. 2011;2011: 768-76.
---------------------------------------------------------------------------
    The High-Risk Drug Classes: Use and Indication data element
requires an assessor to record whether or not a resident is taking any
medications within the six drug classes. The six response options for
this data element are high-risk drug classes with particular relevance
to PAC patients and residents, as identified by our data element
contractor. The six response options are Anticoagulants, Antiplatelets,
Hypoglycemics, Opioids, Antipsychotics, and Antibiotics. For each drug
class, the assessor is required to indicate if the resident is taking
any medications within the class, and, for drug classes in which
medications were being taken, whether indications for all drugs in the
class are noted in the medical record. For example, for the response
option Anticoagulants, if the assessor indicates that the resident is
taking anticoagulant medication, the assessor would then indicate if an
indication is recorded in the medication record for the
anticoagulant(s).
    The High-Risk Drug Classes: Use and Indication data element that is
being proposed as a SPADE was developed as part of a larger set of data
elements to assess medication reconciliation, the process of obtaining
a patient's multiple medication lists and reconciling any
discrepancies. Similar data elements on some high-risk medications are
already included in the MDS. We proposed to modify and expand existing
data elements in the MDS to include additional high-risk drug classes
and indications for all drug classes. For more information on the High-
Risk Drug Classes: Use and Indication data element, we refer readers to
the document titled ``Final Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We sought public input on the relevance of conducting assessments
on medication reconciliation and specifically on the proposed High-Risk
Drug Classes: Use and Indication data element. Our data element
contractor presented data elements related to medication reconciliation
to the TEP convened on April 6 and 7, 2016. The TEP supported a focus
on high-risk drugs, because of higher potential for harm to patients
and residents, and were in favor of a data element to capture whether
or not indications for medications were recorded in the medical record.
A summary of the April 6 and 7, 2016 TEP meeting titled ``SPADE
Technical Expert Panel Summary (First Convening)'' is available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. Medication reconciliation data
elements were also discussed at a second TEP meeting on January 5 and
6, 2017, convened by our data element contractor. At this meeting, the
TEP agreed about the importance of evaluating the medication
reconciliation process, but disagreed about how this could be
accomplished through standardized assessment. The TEP also disagreed
about the usability and appropriateness of using the Beers Criteria to
identify high-risk medications.\116\ A summary of the January 5 and 6,
2017 TEP meeting titled ``SPADE Technical Expert Panel Summary (Second
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
    \116\ American Geriatrics Society 2015 Beers Criteria Update
Expert Panel. American Geriatrics Society. Updated Beers Criteria
for Potentially Inappropriate Medication Use in Older Adults. J Am
Geriatr Soc 2015; 63:2227-2246.
---------------------------------------------------------------------------
    We also solicited public input on data elements related to
medication reconciliation during a public input
[[Page 38797]]
period from April 26 to June 26, 2017. Several commenters expressed
support for the medication reconciliation data elements that were put
on display, noting the importance of medication reconciliation in
preventing medication errors and stated that the items seemed feasible
and clinically useful. A few commenters were critical of the choice of
10 drug classes posted during that comment period, arguing that ADEs
are not limited to high-risk drugs, and raised issues related to
training assessors to correctly complete a valid assessment of
medication reconciliation. A summary report for the April 26 to June
26, 2017 public comment period titled ``SPADE May-June 2017 Public
Comment Summary Report'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The High-Risk Drug Classes: Use and Indication data element was
included in the National Beta Test of candidate data elements conducted
by our data element contractor from November 2017 to August 2018.
Results of this test found the High-Risk Drug Classes: Use and
Indication data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
High-Risk Drug Classes: Use and Indication data element in the National
Beta Test can be found in the document titled ``Final Specifications
for SNF QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. The TEP acknowledged the
challenges of assessing medication safety, but were supportive of some
of the data elements focused on medication reconciliation that were
tested in the National Beta Test. The TEP was especially supportive of
the focus on the six high-risk drug classes and using these classes to
assess whether the indication for a drug is recorded. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts. These
activities provided updates on the field-testing work and solicited
feedback on data elements considered for standardization, including the
High-Risk Drug Classes: Use and Indication data element. One
stakeholder group was critical of the six drug classes included as
response options in the High-Risk Drug Classes: Use and Indication data
element, noting that potentially risky medications (for example, muscle
relaxants) are not included in this list; that there may be important
differences between drugs within classes (for example, more recent
versus older style antidepressants); and that drug allergy information
is not captured. Finally, on November 27, 2018, our data element
contractor hosted a public meeting of stakeholders to present the
results of the National Beta Test and solicit additional comments.
General input on the testing and item development process and concerns
about burden were received from stakeholders during this meeting and
via email through February 1, 2019. Additionally, one commenter
questioned whether the time to complete this SPADE would differ across
settings. A summary of the public input received from the November 27,
2018 stakeholder meeting titled ``Input on Standardized Patient
Assessment Data Elements (SPADEs) Received After November 27, 2018
Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing high-risk drugs and for
whether or not indications are noted for high-risk drugs, stakeholder
input, and strong test results, we proposed that the High-Risk Drug
Classes: Use and Indication data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the High-Risk Drug Classes: Use and Indication data
element as standardized patient assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the High-Risk Drug Classes: Use and Indication
data.
    Comment: Several commenters supported the High-Risk Drug Class data
element.
    Response: We thank the commenters for their support of the High-
Risk Drug Class data element.
    Comment: One commenter requested detailed instructions and examples
in the RAI Manual and a period established for ongoing feedback after
data collection begins. Another commenter questioned whether ``high-
risk drugs'' is the appropriate label for these medications and
questioned whether the training and instruction manuals will cover all
labeled indications within a drug class such as antipsychotics.
    Response: We are committed to providing comprehensive training to
providers for any new data elements, including standardized data
elements, in order to foster common definitions, thereby ensuring the
fidelity of the assessment. Resources available to SNFs will include
the MDS RAI Manual, annual in-person trainings on the MDS, and CMS'
``helpdesk'' web resources.
    We contend that the label of ``high-risk drugs'' is appropriate for
this SPADE. We have selected drug classes that are commonly used by
older adults and are related to adverse drug events which are
clinically significant, preventable, and measurable. Anticoagulants,
antibiotics, and diabetic agents have been implicated in an estimated
46.9 percent (95 percent CI, 44.2 percent-49.7 percent) of emergency
department visits for adverse drug events.\117\ Among older adults
(aged >=65 years), three drug classes (anticoagulants, diabetic agents,
and opioid analgesics) have been implicated in an estimated 59.9
percent (95 percent CI, 56.8 percent-62.9 percent) of emergency
department visits for adverse drug events.\118\ Further, antipsychotic
medications have been identified as a drug class for which there is a
need for increased outreach and educational efforts to reduce use among
older adults.
---------------------------------------------------------------------------
    \117\ Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ,
Budnitz DS. US emergency department visits for outpatient adverse
drug events, 2013-2014. JAMA 2016;316(2):2115-2125.
    \118\ Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ,
Budnitz DS. US emergency department visits for outpatient adverse
drug events, 2013-2014. JAMA 2016;316(2):2115-2125.
---------------------------------------------------------------------------
    The commenter also inquired whether the training and instruction
manuals will cover all labeled indications within a drug class such as
antipsychotics. We wish to clarify that the assessor will be
[[Page 38798]]
recording whether or not a patient is taking any medication within the
named drug classes (for example, antipsychotics), then, if indications
are known for all medications within the drug class. Training and
instruction manuals, as well as the instructional text in the SPADE
itself, will specify that medications be recorded according to their
pharmacological classification, not by how they are used.
    Comment: One commenter noted that an adverse drug event may be a
causal factor for admission to a PAC setting rather than an adverse
drug event occurring while in a PAC setting. Further, the commenter
urged CMS to avoid considering facilities with many patients taking a
high-risk drug as negligent. Another cautioned that the quality of care
of facilities should not be compared based on the mere presence of more
high-risk drugs, which may be due to medical necessity.
    Response: We appreciate the commenters' concern that the mere
presence of medications in these drug classes should not be interpreted
as a measure of quality; that is, we agree that having many patients at
a facility taking high-risk drugs is not in and of itself an indicator
of negligence or poor quality. We believe that medications in these
classes can be safe, effective, and necessary for some patients/
residents receiving care from PAC providers. We believe that each SNF
serves a unique patient population with varying percentages of patients
for whom high-risk medications are medically necessary, and therefore
agree with the commenter that quality of care of PAC providers cannot
be compared based on the presence of high-risk drugs alone.
    Comment: One commenter encouraged CMS to collect more than the use
of, and indication for, the drug. Another commenter suggested that the
proposed antiplatelets item be combined with the existing anticoagulant
MDS item and the proposed hypoglycemic medications item be added to the
existing insulin injections MDS item.
    Response: We appreciate the commenters' recommendations. We believe
that gathering information on the use of and presence of an indication
for these classes of medications is sufficient for a standardized data
element, although we will take the recommendation to collect more
information about medication under consideration in future work
evaluating and refining the SPADEs. We decline the recommendation to
combine antiplatelet and anticoagulants because of the different
clinical considerations and associations related to each of these drug
classes. We also believe that it would be inappropriate to combine the
hypoglycemic drug class with the insulin injections item, as the High-
Risk Drugs: Use and Indication SPADE pertains to all medications, not
only those taken by injection.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the High-Risk Drug Classes: Use
and Indication data element as standardized patient assessment data
beginning with the FY 2022 SNF QRP as proposed.
(4) Medical Condition and Comorbidity Data
    Assessing medical conditions and comorbidities is critically
important for care planning and safety for patients and residents
receiving PAC services, and the standardized assessment of selected
medical conditions and comorbidities across PAC providers is important
for managing care transitions and understanding medical complexity.
    In this section, we discuss our proposals for data elements related
to the medical condition of pain as standardized patient assessment
data. Appropriate pain management begins with a standardized
assessment, and thereafter establishing and implementing an overall
plan of care that is person-centered, multi-modal, and includes the
treatment team and the patient. Assessing and documenting the effect of
pain on sleep, participation in therapy, and other activities may
provide information on undiagnosed conditions and comorbidities and the
level of care required, and do so more objectively than subjective
numerical scores. With that, we assess that taken separately and
together, these proposed data elements are essential for care planning,
consistency across transitions of care, and identifying medical
complexities including undiagnosed conditions. We also conclude that it
is the standard of care to always consider the risks and benefits
associated with a personalized care plan, including the risks of any
pharmacological therapy, especially opioids.\119\ We also conclude that
in addition to assessing and appropriately treating pain through the
optimum mix of pharmacologic, non-pharmacologic, and alternative
therapies, while being cognizant of current prescribing guidelines,
clinicians in partnership with patients are best able to mitigate
factors that contribute to the current opioid
crisis.120 121 122
---------------------------------------------------------------------------
    \119\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \120\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \121\ Fishman SM, Carr DB, Hogans B, et al. Scope and Nature of
Pain- and Analgesia-Related Content of the United States Medical
Licensing Examination (USMLE). Pain Med Malden Mass. 2018;19(3):449-
459. doi:10.1093/pm/pnx336.
    \122\ Fishman SM, Young HM, Lucas Arwood E, et al. Core
competencies for pain management: Results of an interprofessional
consensus summit. Pain Med Malden Mass. 2013;14(7):971-981.
doi:10.1111/pme.12107.
---------------------------------------------------------------------------
    In alignment with our Meaningful Measures Initiative, accurate
assessment of medical conditions and comorbidities of patients and
residents in PAC is expected to make care safer by reducing harm caused
in the delivery of care; promote effective prevention and treatment of
chronic disease; strengthen person and family engagement as partners in
their care; and promote effective communication and coordination of
care. The SPADEs will enable or support: Clinical decision-making and
early clinical intervention; person-centered, high quality care
through: Facilitating better care continuity and coordination; better
data exchange and interoperability between settings; and longitudinal
outcome analysis. Therefore, reliable data elements assessing medical
conditions and comorbidities are needed in order to initiate a
management program that can optimize a patient's or resident's
prognosis and reduce the possibility of adverse events.
    We invited comment that apply specifically to the standardized
patient assessment data for the category of medical conditions and co-
morbidities. We did not receive any comments on the category of medical
conditions and co-morbidities.
    Final decisions on the SPADEs are given below, following more
detailed comments on each SPADE proposal.
(a) Pain Interference (Pain Effect on Sleep, Pain Interference With
Therapy Activities, and Pain Interference With Day-to-Day Activities)
    In acknowledgement of the opioid crisis, we specifically sought
comment on whether or not we should add these pain items in light of
those concerns. Commenters were asked to address to what extent
collection of the data below through patient queries might encourage
providers to prescribe opioids.
[[Page 38799]]
    In the FY 2020 SNF PPS proposed rule (84 FR 17666 through 17668),
we proposed that a set of three data elements on the topic of Pain
Interference (Pain Effect on Sleep, Pain Interference with Therapy
Activities, and Pain Interference with Day-to-Day Activities) meet the
definition of standardized patient assessment data with respect to
medical condition and comorbidity data under section 1899B(b)(1)(B)(iv)
of the Act.
    The practice of pain management began to undergo significant
changes in the 1990s because the inadequate, non-standardized, non-
evidence-based assessment and treatment of pain became a public health
issue.\123\ In pain management, a critical part of providing
comprehensive care is performance of a thorough initial evaluation,
including assessment of both the medical and any biopsychosocial
factors causing or contributing to the pain, with a treatment plan to
address the causes of pain and to manage pain that persists over
time.\124\ Quality pain management, based on current guidelines and
evidence-based practices, can minimize unnecessary opioid prescribing
both by offering alternatives or supplemental treatment to opioids and
by clearly stating when they may be appropriate, and how to utilize
risk-benefit analysis for opioid and non-opioid treatment
modalities.\125\ Pain is not a surprising symptom in PAC patients and
residents, where healing, recovery, and rehabilitation often require
regaining mobility and other functions after an acute event.
Standardized assessment of pain that interferes with function is an
important first step towards appropriate pain management in PAC
settings. The National Pain Strategy called for refined assessment
items on the topic of pain, and describes the need for these improved
measures to be implemented in PAC assessments.\126\ Further, the focus
on pain interference, as opposed to pain intensity or pain frequency,
was supported by the TEP convened by our data element contractor as an
appropriate and actionable metric for assessing pain. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
    \123\ Institute of Medicine. Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education, and
Research. Washington (DC): National Academies Press (US); 2011.
http://www.ncbi.nlm.nih.gov/books/NBK91497/.
    \124\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \125\ National Academies. Pain Management and the Opioid
Epidemic: Balancing Societal and Individual Benefits and Risks of
Prescription Opioid Use. Washington DC: National Academies of
Sciences, Engineering, and Medicine.; 2017.
    \126\ National Pain Strategy: A Comprehensive Population-Health
Level Strategy for Pain. https://iprcc.nih.gov/sites/default/files/HHSNational_Pain_Strategy_508C.pdf.
---------------------------------------------------------------------------
    We appreciate the important concerns related to the misuse and
overuse of opioids in the treatment of pain and to that end we note
that in the FY 2020 SNF PPS proposed rule (84 FR 17663 to 17665) we
proposed a SPADE that assess for the use of, as well as importantly the
indication for the use of, high-risk drugs, including opioids. Further,
in the FY 2017 SNF PPS final rule (81 FR 52039) we adopted the Drug
Regimen Review Conducted With Follow-Up for Identified Issues--Post
Acute Care (PAC) SNF QRP measure which assesses whether PAC providers
were responsive to potential or actual clinically significant
medication issue(s), which includes issues associated with use and
misuse of opioids for pain management, when such issues were
identified.
    We also note that the proposed SPADE related to pain assessment are
not associated with any particular approach to management. Since the
use of opioids is associated with serious complications, particularly
in the elderly,127 128 129 an array of successful non-
pharmacologic and non-opioid approaches to pain management may be
considered PAC providers have historically used a range of pain
management strategies, including non-steroidal anti-inflammatory drugs,
ice, transcutaneous electrical nerve stimulation (TENS) therapy,
supportive devices, acupuncture, and the like. In addition, non-
pharmacological interventions for pain management include, but are not
limited to, biofeedback, application of heat/cold, massage, physical
therapy, stretching and strengthening exercises, chiropractic,
electrical stimulation, radiotherapy, and
ultrasound.130 131 132
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    \127\ Chau, D.L., Walker, V., Pai, L., & Cho, L.M. (2008).
Opiates and elderly: Use and side effects. Clinical interventions in
aging, 3(2), 273-8.
    \128\ Fine, P.G. (2009). Chronic Pain Management in Older
Adults: Special Considerations. Journal of Pain and Symptom
Management, 38(2): S4-S14.
    \129\ Solomon, D.H., Rassen, J.A., Glynn, R.J., Garneau, K.,
Levin, R., Lee, J., & Schneeweiss, S. (2010). Archives Internal
Medicine, 170(22):1979-1986.
    \130\ Byrd L. Managing chronic pain in older adults: Along-term
care perspective. Annals of Long-Term Care: Clinical Care and Aging.
2013;21(12):34-40.
    \131\ Kligler, B., Bair, M.J., Banerjea, R. et al. (2018).
Clinical Policy Recommendations from the VHA State-of-the-Art
Conference on Non-Pharmacological Approaches to Chronic
Musculoskeletal Pain. Journal of General Internal Medicine, 33(Suppl
1): 16. https://doi.org/10.1007/s11606-018-4323-z.
    \132\ Chou, R., Deyo, R., Friedly, J., et al. (2017).
Nonpharmacologic Therapies for Low Back Pain: A Systematic Review
for an American College of Physicians Clinical Practice Guideline.
Annals of Internal Medicine, 166(7):493-505.
---------------------------------------------------------------------------
    We believe that standardized assessment of pain interference will
support PAC clinicians in applying best-practices in pain management
for chronic and acute pain, consistent with current clinical
guidelines. For example, the standardized assessment of both opioids
and pain interference would support providers in successfully tapering
the dosage regimens in patients/residents who arrive in the PAC setting
with long-term opioid use off of opioids onto non-pharmacologic
treatments and non-opioid medications, as recommended by the Society
for Post-Acute and Long-Term Care Medicine,\133\ and consistent with
HHS's 5-Point Strategy To Combat the Opioid Crisis \134\ which includes
``Better Pain Management.''
---------------------------------------------------------------------------
    \133\ Society for Post-Acute and Long-Term Care Medicine (AMDA).
(2018). Opioids in Nursing Homes: Position Statement. https://paltc.org/opioids%20in%20nursing%20homes.
    \134\ https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/index.html.
---------------------------------------------------------------------------
    The Pain Interference data elements consist of three data elements:
Pain Effect on Sleep, Pain Interference with Therapy Activities, and
Pain Interference with Day-to-Day Activities. Pain Effect on Sleep
assesses the frequency with which pain affects a resident's sleep. Pain
Interference with Therapy Activities assesses the frequency with which
pain interferes with a resident's ability to participate in therapies.
The Pain Interference with Day-to-Day Activities assesses the extent to
which pain interferes with a resident's ability to participate in day-
to-day activities excluding therapy.
    A similar data element on the effect of pain on activities is
currently included in the OASIS. A similar data element on the effect
on sleep is currently included in the MDS instrument. We proposed to
expand and modify the existing Pain data elements in the MDS to include
the Pain Effect on Sleep; Pain Interference with Therapy Activities;
and Pain Interference with Day to Day Activities data elements. For
more information on the Pain
[[Page 38800]]
Interference data elements, we refer readers to the document titled
``Final Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We sought public input on the relevance of conducting assessments
on pain and specifically on the larger set of Pain Interview data
elements included in the National Beta Test. The proposed data elements
were supported by comments from the TEP meeting held by our data
element contractor on April 7 to 8, 2016. The TEP affirmed the
feasibility and clinical utility of pain as a concept in a standardized
assessment. The TEP agreed that data elements on pain interference with
ability to participate in therapies versus other activities should be
addressed. Further, during a more recent convening of the same TEP on
September 17, 2018, the TEP supported the interview-based pain data
elements included in the National Beta Test. The TEP members were
particularly supportive of the items that focused on how pain
interferes with activities (that is, Pain Interference data elements),
because understanding the extent to which pain interferes with function
would enable clinicians to determine the need for appropriate pain
treatment. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We held a public input period in 2016 to solicit feedback on the
standardization of pain and several other items that were under
development in prior efforts. From the prior public comment period, we
included several pain data elements (Pain Effect on Sleep; Pain
Interference--Therapy Activities; Pain Interference--Other Activities)
in a second call for public input, open from April 26 to June 26, 2017.
The items we sought comment on were modified from all stakeholder and
test efforts. Commenters provided general comments about pain
assessment in general in addition to feedback on the specific pain
items. A few commenters shared their support for assessing pain, the
potential for pain assessment to improve the quality of care, and for
the validity and reliability of the data elements. Commenters affirmed
that the item of pain and the effect on sleep would be suitable for PAC
settings. Commenters' main concerns included redundancy with existing
data elements, feasibility and utility for cross-setting use, and the
applicability of interview-based items to patients and residents with
cognitive or communication impairments, and deficits. A summary report
for the April 26 to June 26, 2017 public comment period titled ``SPADE
May-June 2017 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Pain Interference data elements were included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Pain Interference data elements to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the Pain Interference data elements in the National Beta
Test can be found in the document titled ``Final Specifications for SNF
QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the
standardized patient assessment data elements. The TEP supported the
interview-based pain data elements included in the National Beta Test.
The TEP members were particularly supportive of the items that focused
on how pain interferes with activities (that is, Pain Interference data
elements), because understanding the extent to which pain interferes
with function would enable clinicians to determine the need for pain
treatment. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, one commenter expressed strong support for the Pain
data elements and was encouraged by the fact that this portion of the
assessment goes beyond merely measuring the presence of pain. A summary
of the public input received from the November 27, 2018 stakeholder
meeting titled ``Input on Standardized Patient Assessment Data Elements
(SPADEs) Received After November 27, 2018 Stakeholder Meeting'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for the effect of pain
on function, stakeholder input, and strong test results, we proposed
that the three Pain Interference data elements (Pain Effect on Sleep,
Pain Interference with Therapy Activities, and Pain Interference with
Day-to-Day Activities) meet the definition of standardized patient
assessment data with respect to medical conditions and comorbidities
under section 1899B(b)(1)(B)(iv) of the Act and to adopt the Pain
Interference (Pain Effect on Sleep, Pain Interference with Therapy
Activities, and Pain Interference with Day-to-Day Activities) data
elements as standardized patient assessment data for use in the SNF
QRP.
    Commenters submitted the following comments related to our proposal
to adopt the Pain Interference data elements (Pain Effect on Sleep,
Pain Interference with Therapy Activities, and Pain Interference with
Day-to-Day Activities).
    Comment: Several commenters expressed support for the Pain
Interference SPADEs, noting that these SPADEs will provide a useful and
more accurate assessment of a patient's ability to function, and that
understanding the impact of pain on therapy and other activities,
including sleep, can improve the quality of care, which in turn will
support providers in their ability to provide effective pain management
services.
[[Page 38801]]
    Response: We thank the commenters for their support of the Pain
Interference data elements.
    Comment: One commenter noted that the proposed Pain Interference
SPADEs document pain frequency but stated that it is important to
identify both pain frequency and pain intensity. Another commenter
noted that the Pain Interference questions do not address frequency of
pain interference.
    Response: We wish to clarify the Pain Interference SPADEs are
interview data elements that ask the patient the frequency with which
pain interferes with sleep, therapy, or non-therapy activities. These
data elements therefore combine the concepts of frequency and
intensity, with the measure of intensity being interference with the
named activities. Self-reported measures of pain intensity are often
criticized for being infeasible to standardize. In these data elements,
interference with activities is an alternative to asking about
intensity.
    Comment: A commenter expressed concerns about the suitability of
the Pain Interference SPADEs for use in patients with cognitive and
communication deficits and urged CMS to consider the use of non-verbal
means to allow patients to respond to SPADEs related to pain. Another
commenter questioned how pain interference would be captured for
residents who refused or were unable to complete the pain interview.
    Response: We appreciate the commenter's concern surrounding pain
assessment with patients with cognitive and communication deficits. The
Pain Interference SPADEs require that a patient be able to communicate,
whether verbally, in writing, or using another method. Assessors may
use non-verbal means to administer the questions (for example,
providing the questions and response in writing for a patient with
severe hearing impairment). Patients who are unable to communicate by
any means, would not be required to complete the Pain Interference
SPADEs. In addition, evidence suggests that pain presence can be
reliably assessed in non-communicative patients through structural
observational protocols. To that end, we tested observational pain
presence elements in the National Beta Test, but have chosen not to
propose those data elements as SPADEs at this time out of consideration
of the scale of additions and changes that would be required of PAC
providers. We will take the commenter's concern into consideration as
the SPADEs are monitored and refined in the future.
    Comment: A commenter expressed concerns about how CMS might use
these data elements, noting particular concern that collection of these
SPADEs may inappropriately translate into an assessment of quality, and
that data collection on this topic could create incentives that
directly or indirectly interfere with treatment decisions.
    Response: We appreciate the commenter's concern related to wanting
to understand how we will use the SPADEs. Any additional uses of these
SPADEs for the assessment of quality will be adopted through the
rulemaking process. We intend to communicate and collaborate with
stakeholders about how the SPADEs will be used in the SNF QRP, as those
plans are developed, by soliciting input through future rulemaking.
    Comment: One commenter noted that there are currently seven MDS
questions in the Resident Pain Assessment and that the current proposal
adds three additional interview questions, but it is unclear if the
existing pain questions will be replaced. This commenter requested that
CMS balance the need for additional documentation requirements with the
impact on the clinician's ability to focus on patient care.
    Response: We acknowledge the commenter's concern about the number
of additional data elements being added to the MDS as part of the Pain
Interview. The MDS currently contains two questions under the heading
Pain Effect on Function (J0500) on the topics of pain interference with
sleep and pain interference with day-to-day activities. The current
items have Yes/No response options. The proposed SPADEs will make two
changes to these items. First, we added a data element on pain
interference with therapy activities. Second, we proposed response
options that reflect the frequency of pain interference on a 5-point
scale, ranging from ``Rarely or not at all'' to ``Almost constantly.''
Other items on the MDS will remain unchanged. By adapting existing data
elements from the MDS and integrating new SPADEs into existing skip
patterns, we believe we have minimized additional documentation
requirements while still ensuring that we have the appropriate data to
foster interoperability, support care planning, and inform quality
measurement.
    Comment: One commenter appreciated CMS' request to provide feedback
on the relation between pain assessment via the proposed Pain
Interference SPADEs and the provider's willingness to prescribe
opioids. This commenter believes CMS should monitor the correlation
between the incidence of prescribing opioids and interview items and
ensure expectations are aligned about what level of pain is acceptable
and tolerable to the patient, through shared decision-making and
education across the care delivery continuum, which includes the
patients, their families, the patient care delivery teams, as well as
regulators and surveyors.
    Response: We intend to monitor the data submitted via the proposed
SPADEs and will consider this use in the future.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Pain Interference data
elements (Pain Effect on Sleep, Pain Interference with Therapy
Activities, and Pain Interference with Day-to-Day Activities) as
standardized patient assessment data beginning with the FY 2022 SNF QRP
as proposed.
(5) Impairment Data
    Hearing and vision impairments are conditions that, if unaddressed,
affect activities of daily living, communication, physical functioning,
rehabilitation outcomes, and overall quality of life. Sensory
limitations can lead to confusion in new settings, increase isolation,
contribute to mood disorders, and impede accurate assessment of other
medical conditions. Failure to appropriately assess, accommodate, and
treat these conditions increases the likelihood that patients and
residents will require more intensive and prolonged treatment. Onset of
these conditions can be gradual, so individualized assessment with
accurate screening tools and follow-up evaluations are essential to
determining which patients and residents need hearing- or vision-
specific medical attention or assistive devices and accommodations,
including auxiliary aids and/or services, and to ensure that person-
directed care plans are developed to accommodate a patient's or
resident's needs. Accurate diagnosis and management of hearing or
vision impairment would likely improve rehabilitation outcomes and care
transitions, including transition from institutional-based care to the
community. Accurate assessment of hearing and vision impairment would
be expected to lead to appropriate treatment, accommodations, including
the provision of auxiliary aids and services during the stay, and
ensure that patients and residents continue to have their vision and
hearing needs met when they leave the facility.
    In alignment with our Meaningful Measures Initiative, we expect
accurate
[[Page 38802]]
and individualized assessment, treatment, and accommodation of hearing
and vision impairments of patients and residents in PAC to make care
safer by reducing harm caused in the delivery of care; promote
effective prevention and treatment of chronic disease; strengthen
person and family engagement as partners in their care; and promote
effective communication and coordination of care. For example,
standardized assessment of hearing and vision impairments used in PAC
will support ensuring patient safety (for example, risk of falls),
identifying accommodations needed during the stay, and appropriate
support needs at the time of discharge or transfer. Standardized
assessment of these data elements will: Enable or support clinical
decision-making and early clinical intervention; person-centered, high
quality care (for example, facilitating better care continuity and
coordination); better data exchange and interoperability between
settings; and longitudinal outcome analysis. Therefore, reliable data
elements assessing hearing and vision impairments are needed to
initiate a management program that can optimize a patient's or
resident's prognosis and reduce the possibility of adverse events.
    Comments on the category of impairments were also submitted by
stakeholders during the FY 2018 SNF PPS proposed rule (82 FR 21074
through 21076) public comment period. A commenter stated hearing,
vision, and communication assessments should be administered at the
beginning of assessment process, to provide evidence about any sensory
deficits that may affect the patient's or resident's ability to
participate in the assessment and to allow the assessor to offer an
assistive device. Another commenter supported the decision to assess
hearing and vision with respect to admission and not discharge, and to
use existing MDS items for hearing and vision, thereby not creating
additional burden.
    We invited comment on our proposals to collect as standardized
patient assessment data the following data with respect to impairments.
Commenters submitted the following comments related to the proposed
rule's discussion of Impairments.
    Comment: One commenter was concerned that screening for impairments
would lead to an expectation that SNFs would need to take on the burden
and cost of pursuing treatment for these impairments on short-stay SNF
patients. This commenter suggested a provision be added to the final
rule to clarify that a SNF is not responsible for pursuing treatments
and services beyond the scope of care and services normally provided by
the SNF.
    Response: We appreciate the commenter's concern. The adoption of
SPADEs related to hearing and vision impairment are intended to collect
data related to patient acuity and to ensure that clinically important
information is assessed in a standardized way across settings, to
support interoperability and care transitions. The adoption of the
Hearing and Vision SPADEs does not affect the expectations that CMS has
for SNF providers to provide a standard of care to residents that
conforms to the CoPs. Under 42 CFR 483.21(b)(1), the facility must
provide the treatment and services set out in the resident's care plan.
The facility, however, may transfer or discharge a resident under 42
CFR 483.15(c)(1)(i)(A) if his or her needs cannot be met at that
facility.
    Final decisions on the SPADEs are given below, following more
detailed comments on each SPADE proposal.
(a) Hearing
    In the FY 2020 SNF PPS proposed rule (84 FR 17668 through 17669),
we proposed that the Hearing data element meets the definition of
standardized patient assessment data with respect to impairments under
section 1899B(b)(1)(B)(v) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21074
through 21075), accurate assessment of hearing impairment is important
in the PAC setting for care planning and resource use. Hearing
impairment has been associated with lower quality of life, including
poorer physical, mental, social functioning, and emotional
health.135 136 Treatment and accommodation of hearing
impairment led to improved health outcomes, including but not limited
to quality of life.\137\ For example, hearing loss in elderly
individuals has been associated with depression and cognitive
impairment,138 139 140 higher rates of incident cognitive
impairment and cognitive decline,\141\ and less time in occupational
therapy.\142\ Accurate assessment of hearing impairment is important in
the PAC setting for care planning and defining resource use.
---------------------------------------------------------------------------
    \135\ Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL,
Nondahl DM. The impact of hearing loss on quality of life in older
adults. Gerontologist. 2003;43(5):661-668.
    \136\ Hawkins K, Bottone FG, Jr., Ozminkowski RJ, et al. The
prevalence of hearing impairment and its burden on the quality of
life among adults with Medicare Supplement Insurance. Qual Life Res.
2012;21(7):1135-1147.
    \137\ Horn KL, McMahon NB, McMahon DC, Lewis JS, Barker M,
Gherini S. Functional use of the Nucleus 22-channel cochlear implant
in the elderly. The Laryngoscope. 1991;101(3):284-288.
    \138\ Sprinzl GM, Riechelmann H. Current trends in treating
hearing loss in elderly people: A review of the technology and
treatment options--a mini-review. Gerontology. 2010;56(3):351-358.
    \139\ Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing
Loss Prevalence and Risk Factors Among Older Adults in the United
States. The Journals of Gerontology Series A: Biological Sciences
and Medical Sciences. 2011;66A(5):582-590.
    \140\ Hawkins K, Bottone FG, Jr., Ozminkowski RJ, et al. The
prevalence of hearing impairment and its burden on the quality of
life among adults with Medicare Supplement Insurance. Qual Life Res.
2012;21(7):1135-1147.
    \141\ Lin FR, Metter EJ, O'Brien RJ, Resnick SM, Zonderman AB,
Ferrucci L. Hearing Loss and Incident Dementia. Arch Neurol.
2011;68(2):214-220.
    \142\ Cimarolli VR, Jung S. Intensity of Occupational Therapy
Utilization in Nursing Home Residents: The Role of Sensory
Impairments. J Am Med Dir Assoc. 2016;17(10):939-942.
---------------------------------------------------------------------------
    The proposed data element consists of the single Hearing data
element. This data consists of one question that assesses level of
hearing impairment. This data element is currently in use in the MDS in
SNFs. For more information on the Hearing data element, we refer
readers to the document titled ``Final Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Hearing data element was first proposed as a SPADE in the FY
2018 SNF PPS proposed rule (82 FR 21074 through 21075). In that
proposed rule, we stated that the proposal was informed by input we
received on the PAC PRD form of the data element (``Ability to Hear'')
through a call for input published on the CMS Measures Management
System Blueprint website. Input submitted from August 12 to September
12, 2016 recommended that hearing, vision, and communication
assessments be administered at the beginning of patient assessment
process. A summary report for the August 12 to September 12, 2016
public comment period titled ``SPADE August 2016 Public Comment Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported Hearing as a standardized patient assessment
data element to facilitate care coordination. One stated that coding
instructions
[[Page 38803]]
about use of a hearing device by the resident should be more clearly
defined. Commenters were supportive of adopting the Hearing data
element for standardized cross-setting use, noting that it would help
address the needs of patient and residents with disabilities and that
failing to identify impairments during the initial assessment can
result in inaccurate diagnoses of impaired language or cognition and
can validate other information obtained from patient assessment.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Hearing data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Hearing
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Hearing data
element in the National Beta Test can be found in the document titled
``Final Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on January
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs,
including the Hearing data element. The TEP affirmed the importance of
standardized assessment of hearing impairment in PAC patients and
residents. A summary of the January 5 and 6, 2017 TEP meeting titled
``SPADE Technical Expert Panel Summary (Second Convening)'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, a commenter expressed support for the Hearing data
element and suggested administration at the beginning of the patient
assessment to maximize utility. A summary of the public input received
from the November 27, 2018 stakeholder meeting titled ``Input on
Standardized Patient Assessment Data Elements (SPADEs) Received After
November 27, 2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for hearing,
stakeholder input, and strong test results, we proposed that the
Hearing data element meets the definition of standardized patient
assessment data with respect to impairments under section
1899B(b)(1)(B)(v) of the Act and to adopt the Hearing data element as
standardized patient assessment data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Hearing data element.
    Comment: Three commenters supported the collection of information
on hearing impairment. One of these commenters also suggested that CMS
consider how hearing impairment impacts a patient's ability to respond
to the assessment tool in general.
    Response: We thank the commenters for their support of the Hearing
data element.
    Comment: One commenter recommended adding ``unable to assess'' as a
response option, which the commenter believed would be the appropriate
choice if a patient has a diagnosis that may limit a hearing
assessment.
    Response: We appreciate the commenter's recommendation. The
assessment of hearing is completed based on observing the patient
during assessment, patient interactions with others, reviewing medical
record documentation, and consulting with patient's family and other
staff, in addition to interviewing the patient. Therefore, the
assessment can be completed when the patient is unable to effectively
answer questions related to an assessment of their hearing.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Hearing data element as
standardized patient assessment data beginning with the FY 2022 SNF QRP
as proposed.
(b) Vision
    In the FY 2020 SNF PPS proposed rule (84 FR 17669 through 17671),
we proposed that the Vision data element meets the definition of SPADE
with respect to impairments under section 1899B(b)(1)(B)(v) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21075
through 21076), evaluation of an individual's ability to see is
important for assessing for risks such as falls and provides
opportunities for improvement through treatment and the provision of
accommodations, including auxiliary aids and services, which can
safeguard patients and residents and improve their overall quality of
life. Further, vision impairment is often a treatable risk factor
associated with adverse events and poor quality of life. For example,
individuals with visual impairment are more likely to experience falls
and hip fracture, have less mobility, and report depressive
symptoms.143 144 145 146 147 148 149 Individualized initial
screening can lead to life-improving interventions such as
accommodations, including the provision of auxiliary aids and services,
during the stay and/or treatments that can improve vision and prevent
or slow further vision loss. In addition, vision impairment is often a
treatable risk factor associated with adverse events which can be
prevented and accommodated during the stay. Accurate assessment of
vision impairment is important in the SNF setting for care planning and
defining resource use.
---------------------------------------------------------------------------
    \143\ Colon-Emeric CS, Biggs DP, Schenck AP, Lyles KW. Risk
factors for hip fracture in skilled nursing facilities: Who should
be evaluated? Osteoporos Int. 2003;14(6):484-489.
    \144\ Freeman EE, Munoz B, Rubin G, West SK. Visual field loss
increases the risk of falls in older adults: The Salisbury eye
evaluation. Invest Ophthalmol Vis Sci. 2007;48(10):4445-4450.
    \145\ Keepnews D, Capitman JA, Rosati RJ. Measuring patient-
level clinical outcomes of home health care. J Nurs Scholarsh.
2004;36(1):79-85.
    \146\ Nguyen HT, Black SA, Ray LA, Espino DV, Markides KS.
Predictors of decline in MMSE scores among older Mexican Americans.
J Gerontol A Biol Sci Med Sci. 2002;57(3):M181-185.
    \147\ Prager AJ, Liebmann JM, Cioffi GA, Blumberg DM. Self-
reported Function, Health Resource Use, and Total Health Care Costs
Among Medicare Beneficiaries With Glaucoma. JAMA ophthalmology.
2016;134(4):357-365.
    \148\ Rovner BW, Ganguli M. Depression and disability associated
with impaired vision: the MoVies Project. J Am Geriatr Soc.
1998;46(5):617-619.
    \149\ Tinetti ME, Ginter SF. The nursing home life-space
diameter. A measure of extent and frequency of mobility among
nursing home residents. J Am Geriatr Soc. 1990;38(12):1311-1315.
---------------------------------------------------------------------------
    The proposed data element consists of the single Vision data
element (Ability To See in Adequate Light) that consists of one
question with five response categories. The Vision data element that we
proposed for standardization was tested as part of the development of
the
[[Page 38804]]
MDS in SNFs and is currently in use in that assessment. Similar data
elements, but with different wording and fewer response option
categories, are in use in the OASIS. For more information on the Vision
data element, we refer readers to the document titled ``Final
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Vision data element was first proposed as a SPADE in the FY
2018 SNF PPS proposed rule (82 FR 21075 through 21076). In that
proposed rule, we stated that the proposal was informed by input we
received on the Ability to See in Adequate Light data element (version
tested in the PAC PRD with three response categories) through a call
for input published on the CMS Measures Management System Blueprint
website. Although the data element in public comment differed from the
proposed data element, input submitted from August 12 to September 12,
2016 supported assessing vision in PAC settings and the useful
information a vision data element would provide. We also stated that
commenters had noted that the Ability to See item would provide
important information that would facilitate care coordination and care
planning, and consequently improve the quality of care. Other
commenters suggested it would be helpful as an indicator of resource
use and noted that the item would provide useful information about the
abilities of patients and residents to care for themselves. Additional
commenters noted that the item could feasibly be implemented across PAC
providers and that its kappa scores from the PAC PRD support its
validity. Some commenters noted a preference for MDS version of the
Vision data element in SNFs over the form put forward in public
comment, citing the widespread use of this data element. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule,
some commenters supported Vision as a standardized patient assessment
data element to facilitate care coordination. One stated that coding
instructions for use of a vision device by the resident should be more
clearly defined. Commenters recommended that hearing, vision, and
communication assessments be administered at the beginning of patient
assessment process. One commenter supported having a SPADE for vision
across PAC settings, but stated it captures only basic information for
risk adjustment, and more detailed information would need to be
collected to use it as an outcome measure.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Vision data element was included in the National Beta Test of candidate
data elements conducted by our data element contractor from November
2017 to August 2018. Results of this test found the Vision data element
to be feasible and reliable for use with PAC patients and residents.
More information about the performance of the Vision data element in
the National Beta Test can be found in the document titled ``Final
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on January
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs
including the Vision data element. The TEP affirmed the importance of
standardized assessment of vision impairment in PAC patients and
residents. A summary of the January 5 and 6, 2017 TEP meeting titled
``SPADE Technical Expert Panel Summary (Second Convening)'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, a commenter expressed support for the Vision data
element and suggested administration at the beginning of the patient
assessment to maximize utility. A summary of the public input received
from the November 27, 2018 stakeholder meeting titled ``Input on
Standardized Patient Assessment Data Elements (SPADEs) Received After
November 27, 2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for vision, stakeholder
input, and strong test results, we proposed that the Vision data
element meets the definition of standardized patient assessment data
with respect to impairments under section 1899B(b)(1)(B)(v) of the Act
and to adopt the Vision data element as standardized patient assessment
data for use in the SNF QRP.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Vision data element.
    Comment: A few commenters supported the collection of information
on vision impairment. One of these commenters additionally recommended
that a doctor of optometry should play a lead role in conducting vision
assessments, and that vision assessments done by other clinicians
should also obtain the patient's own assessment of his or her vision,
such as used by the Centers for Disease Control and Prevention (CDC)
Behavioral Risk Factors Surveillance System survey, which asks patients
``Do you have serious difficulty seeing, even when wearing glasses?''
This commenter expressed concerns about the proposed SPADE being
subjective and risks of mis-categorizing patients.
    Response: We thank the commenters for their support. We also
appreciate the commenter's recommendation about how to assess for
vision impairment. We do not require that a certain type of clinician
complete assessments; the SPADEs have been developed so that any
clinician who is trained in the administration of the assessment will
be able to administer it correctly. The proposed item relies on the
assessor's evaluation of the patient's vision, which has the advantage
of reducing burden placed on the patient. We will take the
recommendation to use patient-reported vision impairment assessment
into consideration in the development of future assessments.
    Comment: A commenter also urged CMS to require vision assessment at
[[Page 38805]]
discharge, noting that vision impairment could be related to challenges
in medication management and compliance with written follow-up
instructions for care.
    Response: We appreciate the commenter's feedback. We agree that
adequate vision--or the accommodations and assistive technology needed
to compensate for vision impairment--is important to patient safety in
the community, in part for the reasons the commenter mentions. In the
FY 2020 SNF PPS proposed rule (84 FR 17644), we proposed that SNFs that
submit the Vision SPADE with respect to admission will be deemed to
have submitted with respect to both admission and discharge, as there
is a low likelihood that the assessment of this SPADEs at admission
would differ from the assessment at discharge. Vision assessment,
collected via the Vision SPADE with respect to admission, will provide
information that will support the patient's care while in the SNF. We
also contend that significant clinical changes to a patient's vision
will be documented in the medical record as part of routine clinical
practice, and would therefore be known to the provider at the time of
discharge. Awareness of the patient's vision impairment would likely
require accommodations with regard to written follow up instructions
and medication management plan, but the information on visual
impairment at discharge would be available in the medical record even
though it would not be collected as part of the Vision SPADE.
    Out of consideration for the burden of data collection, and based
on our understanding of visual impairments being monitored by providers
throughout a patient's episode of care, SNFs that submit the Vision
SPADE with respect to admission will be deemed to have submitted with
respect to both admission and discharge. We note that during the
discharge planning process, it is incumbent on SNF providers to make
reasonable assurances that the patient's needs will be met in the next
care setting, including in the home.
    Comment: One commenter recommended adding ``unable to assess'' as a
response option, which the commenter believed would be the appropriate
choice if a patient has a diagnosis that may limit a vision assessment.
    Response: We appreciate the commenter's recommendation. However,
the assessment of vision is completed based on consulting with
patient's family and other staff, observing the patient, including
asking the patient to read text or examine pictures or numbers, in
addition to interviewing the patient about their vision abilities.
These other sources/methods can be used to complete the assessment of
vision when the patient is unable to effectively answer questions
related to an assessment of their vision.
    Comment: One commenter noted that assessment through the vision
data element is just an initial step towards a care coordination system
that recognizes the impact that eye health has on overall health
outcomes. This commenter noted that a critical next step would be to
ensure that patients get to the physician who can address their eye
health needs.
    Response: We appreciate the commenter's recommendation and we agree
that screening for vision impairment is an initial step towards
ensuring patients receive the care they need. We expect SNF providers
to provide a standard of care to residents that conforms to the CoPs,
and we defer to the clinical judgement of the resident's care team to
determine when further assessment of vision or eye-related issues is
warranted.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Vision data element as
standardized patient assessment data beginning with the FY 2022 SNF QRP
as proposed.
(6) New Category: Social Determinants of Health
(a) Social Determinants of Health Data Collection To Inform Measures
and Other Purposes
    Subparagraph (A) of section 2(d)(2) of the IMPACT Act requires CMS
to assess appropriate adjustments to quality measures, resource
measures, and other measures, and to assess and implement appropriate
adjustments to payment under Medicare based on those measures, after
taking into account studies conducted by ASPE on social risk factors
(described below) and other information, and based on an individual's
health status and other factors. Subparagraph (C) of section 2(d)(2) of
the IMPACT Act further requires the Secretary to carry out periodic
analyses, at least every three years, based on the factors referred to
subparagraph (A) so as to monitor changes in possible relationships.
Subparagraph (B) of section 2(d)(2) of the IMPACT Act requires CMS to
collect or otherwise obtain access to data necessary to carry out the
requirement of the paragraph (both assessing adjustments described
above in such subparagraph (A) and for periodic analyses in such
subparagraph (C)). Accordingly we proposed to use our authority under
subparagraph (B) of section 2(d)(2) of the IMPACT Act to establish a
new data source for information to meet the requirements of
subparagraphs (A) and (C) of section 2(d)(2) of the IMPACT Act. We
proposed to collect and access data about social determinants of health
(SDOH) in order to perform CMS' responsibilities under subparagraphs
(A) and (C) of section 2(d)(2) of the IMPACT Act, as explained in more
detail below. Social determinants of health, also known as social risk
factors, or health-related social needs, are the socioeconomic,
cultural and environmental circumstances in which individuals live that
impact their health. We proposed to collect information on seven
proposed SDOH SPADE data elements relating to race, ethnicity,
preferred language, interpreter services, health literacy,
transportation, and social isolation; a detailed discussion of each of
the proposed SDOH data elements is found in section III.E.1.g.(6) of
this final rule.
    We also proposed to use the resident assessment instrument minimum
data set (MDS), the current version being MDS 3.0, described as a PAC
assessment instrument under section 1899B(a)(2)(B) of the Act, to
collect these data via an existing data collection mechanism. We
believe this approach will provide CMS with access to data with respect
to the requirements of section 2(d)(2) of the IMPACT Act, while
minimizing the reporting burden on PAC health care providers by relying
on a data reporting mechanism already used and an existing system to
which PAC health care providers are already accustomed.
    The IMPACT Act includes several requirements applicable to the
Secretary, in addition to those imposing new data reporting obligations
on certain PAC providers as discussed in section III.E.1.h.(4) of this
final rule. Subparagraphs (A) and (B) of section 2(d)(1) of the IMPACT
Act require the Secretary, acting through the Office of the Assistant
Secretary for Planning and Evaluation (ASPE), to conduct two studies
that examine the effect of risk factors, including individuals'
socioeconomic status, on quality, resource use and other measures under
the Medicare program. The first ASPE study was completed in December
2016 and is discussed below, and the second study is to be completed in
the fall of 2019. We recognize that ASPE, in its studies, is
considering a broader range of social risk factors than the SDOH data
elements in this proposal, and address both PAC and non-PAC settings.
We
[[Page 38806]]
acknowledge that other data elements may be useful to understand, and
that some of those elements may be of particular interest in non-PAC
settings. For example, for beneficiaries receiving care in the
community, as opposed to an in-patient facility, housing stability and
food insecurity may be more relevant. We will continue to take into
account the findings from both of ASPE's reports in future policy
making.
    One of the ASPE's first actions under the IMPACT Act was to
commission the National Academies of Sciences, Engineering, and
Medicine (NASEM) to define and conceptualize socioeconomic status for
the purposes of ASPE's two studies under section 2(d)(1) of the IMPACT
Act. The NASEM convened a panel of experts in the field and conducted
an extensive literature review. Based on the information collected, the
2016 NASEM panel report titled, ``Accounting for Social Risk Factors in
Medicare Payment: Identifying Social Risk Factors,'' concluded that the
best way to assess how social processes and social relationships
influence key health-related outcomes in Medicare beneficiaries is
through a framework of social risk factors instead of socioeconomic
status. Social risk factors discussed in the NASEM report include
socioeconomic position, race, ethnicity, gender, social context, and
community context. These factors are discussed at length in chapter 2
of the NASEM report, titled ``Social Risk Factors.'' \150\ Consequently
NASEM framed the results of its report in terms of ``social risk
factors'' rather than ``socioeconomic status'' or ``sociodemographic
status.'' The full text of the ``Social Risk Factors'' NASEM report is
available for reading on the website at https://www.nap.edu/read/21858/chapter/1.
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    \150\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Chapter 2. Washington, DC: The
National Academies Press.
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    Each of the data elements we proposed to collect and access under
our authority under section 2(d)(2)(B) of the IMPACT Act is identified
in the 2016 NASEM report as a social risk factor that has been shown to
impact care use, cost and outcomes for Medicare beneficiaries. CMS uses
the term social determinants of health (SDOH) to denote social risk
factors, which is consistent with the objectives of Healthy People
2020.\151\
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    \151\ Social Determinants of Health. Healthy People 2020.
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
---------------------------------------------------------------------------
    ASPE issued its first Report to Congress, titled ``Social Risk
Factors and Performance Under Medicare's Value-Based Purchasing
Programs,'' under section 2(d)(1)(A) of the IMPACT Act on December 21,
2016.\152\ Using NASEM's social risk factors framework, ASPE focused on
the following social risk factors, in addition to disability: (1) Dual
enrollment in Medicare and Medicaid as a marker for low income, (2)
residence in a low-income area, (3) Black race, (4) Hispanic ethnicity,
and; (5) residence in a rural area. ASPE acknowledged that the social
risk factors examined in its report were limited due to data
availability. The report also noted that the data necessary to
meaningfully attempt to reduce disparities and identify and reward
improved outcomes for beneficiaries with social risk factors have not
been collected consistently on a national level in post-acute care
settings. Where these data have been collected, the collection
frequently involves lengthy questionnaires. More information on the
Report to Congress on Social Risk Factors and Performance under
Medicare's Value-Based Purchasing Programs, including the full report,
is available on the website at https://aspe.hhs.gov/social-risk-factors-and-medicares-value-based-purchasing-programs-reports.
---------------------------------------------------------------------------
    \152\ U.S. Department of Health and Human Services, Office of
the Assistant Secretary for Planning and Evaluation. 2016. Report to
Congress: Social Risk Factors and Performance Under Medicare's
Value-Based Payment Programs. Washington, DC.
---------------------------------------------------------------------------
    Section 2(d)(2) of the IMPACT Act relates to CMS activities and
imposes several responsibilities on the Secretary relating to quality,
resource use, and other measures under Medicare. As mentioned
previously, under subparagraph (A) of section 2(d)(2) of the IMPACT
Act, the Secretary is required, on an ongoing basis, taking into
account the ASPE studies and other information, and based on an
individual's health status and other factors, to assess appropriate
adjustments to quality, resource use, and other measures, and to assess
and implement appropriate adjustments to Medicare payments based on
those measures. Section 2(d)(2)(A)(i) of the IMPACT Act applies to
measures adopted under sections (c) and (d) of section 1899B of the Act
and to other measures under Medicare. However, CMS' ability to perform
these analyses, and assess and make appropriate adjustments is hindered
by limits of existing data collections on SDOH data elements for
Medicare beneficiaries. In its first study in 2016, in discussing the
second study, ASPE noted that information relating to many of the
specific factors listed in the IMPACT Act, such as health literacy,
limited English proficiency, and Medicare beneficiary activation, are
not available in Medicare data.
    Subparagraph 2(d)(2)(A) of the IMPACT Act specifically requires the
Secretary to take the studies and considerations from ASPE's reports to
Congress, as well as other information as appropriate, into account in
assessing and implementing adjustments to measures and related payments
based on measures in Medicare. The results of the ASPE's first study
demonstrated that Medicare beneficiaries with social risk factors
tended to have worse outcomes on many quality measures, and providers
who treated a disproportionate share of beneficiaries with social risk
factors tended to have worse performance on quality measures. As a
result of these findings, ASPE suggested a three-pronged strategy to
guide the development of value-based payment programs under which all
Medicare beneficiaries receive the highest quality healthcare services
possible. The three components of this strategy are to: (1) Measure and
report quality of care for beneficiaries with social risk factors; (2)
set high, fair quality standards for care provided to all
beneficiaries; and (3) reward and support better outcomes for
beneficiaries with social risk factors. In discussing how measuring and
reporting quality for beneficiaries with social risk factors can be
applied to Medicare quality payment programs, the report offered nine
considerations across the three-pronged strategy, including enhancing
data collection and developing statistical techniques to allow
measurement and reporting of performance for beneficiaries with social
risk factors on key quality and resource use measures.
    Congress, in section 2(d)(2)(B) of the IMPACT Act, required the
Secretary to collect or otherwise obtain access to the data necessary
to carry out the provisions of paragraph (2) of section 2(d) of the
IMPACT Act through both new and existing data sources. Taking into
consideration NASEM's conceptual framework for social risk factors
discussed above, ASPE's study, and considerations under section
2(d)(1)(A) of the IMPACT Act, as well as the current data constraints
of ASPE's first study and its suggested considerations, we proposed to
collect and access data about SDOH under section 2(d)(2) of the IMPACT
Act. Our collection and use of the SDOH data described in section
III.E.1.g.(6) of this final rule, under
[[Page 38807]]
section 2(d)(2) of the IMPACT Act, would be independent of our proposal
below (in section III.E.1.g.(6) of this final rule) and our authority
to require submission of that data for use as SPADE under section
1899B(a)(1)(B) of the Act.
    Accessing standardized data relating to the SDOH data elements on a
national level is necessary to permit CMS to conduct periodic analyses,
to assess appropriate adjustments to quality measures, resource use
measures, and other measures, and to assess and implement appropriate
adjustments to Medicare payments based on those measures. We agree with
ASPE's observations, in the value-based purchasing context, that the
ability to measure and track quality, outcomes, and costs for
beneficiaries with social risk factors over time is critical as
policymakers and providers seek to reduce disparities and improve care
for these groups. Collecting the data as proposed will provide the
basis for our periodic analyses of the relationship between an
individual's health status and other factors and quality, resource use,
and other measures, as required by section 2(d)(2) of the IMPACT Act,
and to assess appropriate adjustments. These data will also permit us
to develop the statistical tools necessary to maximize the value of
Medicare data, reduce costs and improve the quality of care for all
beneficiaries. Collecting and accessing SDOH data in this way also
supports the three-part strategy put forth in the first ASPE report,
specifically ASPE's consideration to enhance data collection and
develop statistical techniques to allow measurement and reporting of
performance for beneficiaries with social risk factors on key quality
and resource use measures.
    For the reasons discussed above, we proposed under section 2(d)(2)
of the IMPACT Act, to collect the data on the following SDOH: (1) Race,
as described in section III.E.1.g.(6)(b)(i) of this final rule; (2)
Ethnicity, as described in section III.E.1.g.(6)(b)(i) of this final
rule; (3) Preferred Language, as described in section
III.E.1.g.(6)(b)(ii) of this final rule; (4) Interpreter Services as
described in section III.E.1.g.(6)(b)(ii) of this final rule; (5)
Health Literacy, as described in section III.E.1.g.(6)(b)(iii) of this
final rule; (6) Transportation, as described in section
III.E.1.g.(6)(b)(iv) of this final rule; and (5) Social Isolation, as
described in section III.E.1.g.(6)(b)(v) of this final rule. These data
elements are discussed in more detail below in section III.E.1.g.(6)(b)
of this final rule. A detailed discussion of the comments we received,
along with our responses, is included in each section.
(b) Standardized Patient Assessment Data
    Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to
collect SPADEs with respect to other categories deemed necessary and
appropriate. Below we proposed to create a Social Determinants of
Health SPADE category under section 1899B(b)(1)(B)(vi) of the Act. In
addition to collecting SDOH data for the purposes outlined above under
section 2(d)(2)(B) of the IMPACT Act, we also proposed to collect as
SPADE these same data elements (race, ethnicity, preferred language,
interpreter services, health literacy, transportation, and social
isolation) under section 1899B(b)(1)(B)(vi) of the Act. We believe that
this proposed new category of Social Determinants of Health will inform
provider understanding of individual patient risk factors and treatment
preferences, facilitate coordinated care and care planning, and improve
patient outcomes. We proposed to deem this category necessary and
appropriate, for the purposes of SPADE, because using common standards
and definitions for PAC data elements is important in ensuring
interoperable exchange of longitudinal information between PAC
providers and other providers to facilitate coordinated care,
continuity in care planning, and the discharge planning process from
post-acute care settings.
    All of the Social Determinants of Health data elements we proposed
under section 1899B(b)(1)(B)(vi) of the Act have the capacity to take
into account treatment preferences and care goals of residents and
patients, and to inform our understanding of resident and patient
complexity and risk factors that may affect care outcomes. While
acknowledging the existence and importance of additional social
determinants of health, we proposed to assess some of the factors
relevant for patients and residents receiving post-acute care that PAC
settings are in a position to impact through the provision of services
and supports, such as connecting patients and residents with identified
needs with transportation programs, certified interpreters, or social
support programs.
    We proposed to adopt the following seven data elements as SPADE
under the proposed Social Determinants of Health category: Race,
ethnicity, preferred language, interpreter services, health literacy,
transportation, and social isolation. To select these data elements, we
reviewed the research literature, a number of validated assessment
tools and frameworks for addressing SDOH currently in use (for example,
Health Leads, NASEM, Protocol for Responding to and Assessing Patients'
Assets, Risks, and Experiences (PRAPARE), and ICD-10), and we engaged
in discussions with stakeholders. We also prioritized balancing the
reporting burden for PAC providers with our policy objective to collect
SPADEs that will inform care planning and coordination and quality
improvement across care settings. Furthermore, incorporating SDOH data
elements into care planning has the potential to reduce readmissions
and help beneficiaries achieve and maintain their health goals.
    We also considered feedback received during a listening session
that we held on December 13, 2018. The purpose of the listening session
was to solicit feedback from health systems, research organizations,
advocacy organizations and state agencies and other members of the
public on collecting patient-level data on SDOH across care settings,
including consideration of race, ethnicity, spoken language, health
literacy, social isolation, transportation, sex, gender identity, and
sexual orientation. We also gave participants an option to submit
written comments. A full summary of the listening session, titled
``Listening Session on Social Determinants of Health Data Elements:
Summary of Findings,'' includes a list of participating stakeholders
and their affiliations, and is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We solicited comment on these proposals.
    Comment: One commenter supported the incorporation of SDOH to
promote access and assure high[hyphen]quality care for all
beneficiaries, but encouraged CMS to be mindful of meaningful
collection and the potential for data overload as well as the ability
to leverage existing data sources from across care settings. Since SDOH
have impacts far beyond the post[hyphen]acute care (PAC) setting, the
commenter cautioned data collection that cannot be readily gathered,
shared, or replicated beyond the PAC setting.
    The commenter encouraged CMS to consider leveraging data points
from primary care visits and pointed out that the ability to have a
hospital's or physician's EHR also collect, capture, and exchange
segments of this information is powerful. The commenter recommended
that CMS take a holistic view of SDOH across the care continuum so that
all care settings
[[Page 38808]]
may gather, collect or leverage this data efficiently and impactfully.
    Response: We agree that collecting SDOH data elements can be useful
in identifying and address health disparities and agree with the
feedback that we should be mindful of meaningful collection of SDOH
data collection efforts so that data elements that are selected are
useful. The proposed SDOH SPADEs are aligned with SDOH identified in
the 2016 National Academies of Sciences, Engineering, and Medicine
(NASEM) report, which was commissioned by Office of the Assistant
Secretary for Planning and Evaluation (ASPE). Regarding the commenter's
suggestion that we consider how it can align existing and future SDOH
data elements to minimize burden on providers, we agree that it is
important to minimize duplication efforts and will take this under
advisement for future consideration.
    Comment: One commenter supported and applauded CMS' recognition of
the impact of social determinants of health (SDOH), as well as its
efforts to implement a data collection process for social risk factors.
However, the commenter is concerned that CMS proposed to implement
untested data elements and recommended CMS should first develop a
thoughtful data analysis plan, as it has done in other provider
settings that uses a proxy for SDOH to help inform next steps in data
collection at the patient level.
    Response: We want to note that each of the data elements proposed
is currently in use and was developed with significant testing as part
of our analysis plan before proposing. Additionally, as provided in the
FY 2020 SNF PPS proposed rule (84 FR 17620), the proposed SPADE was
developed after consideration of feedback we received from stakeholders
and four TEPs convened by our contractors.
    Comment: One commenter is pleased to see the proposal for a new
category of SPADEs that would collect data on SDOH. In addition to
potentially adding to the provider's knowledge of the individual, when
aggregated, this information will allow for greater understanding of
the needs of vulnerable populations as well as permit the creation of
tools to assess provider performance on quality metrics among different
populations. One commenter recommended that CMS may also want to
consider adding level of education to the data collected regarding
social determinants of health.
    Response: We will consider this feedback as we continue to improve
and refine the SPADEs.
    Comment: One commenter supported CMS' continuing emphasis on SDOH
and recognized that well-executed SDOH approaches have wide-ranging
effects on government payment systems, and are interconnected to the
development of QRP reporting requirements. The commenter noted that any
change to payment methodologies should account for these factors to
maintain access to care in an equitable manner. Another commenter
supports CMS' proposal to adopt the seven data elements as SPADEs under
the proposed SDOH.
    Response: We agree that SDOH impact patient outcomes and healthcare
costs. We will share your feedback with those who provide oversight for
the SNF prospective payment system.
    Comment: Commenters were generally in favor of the concept of
collecting SDOH data elements and provided that if implemented
appropriately the data could be useful in identifying and addressing
health care disparities, as well as refining the risk adjustment of
outcome measures. However, some of the commenters suggested that CMS
not finalize the proposed policy until it can address important issues
around the potential future uses of these elements and the requirements
around data collection for certain elements. The commenters provided
that CMS did not state explicitly in the rule whether it anticipates
the SDOH SPADEs will be used in adjusting measures and believe that the
IMPACT Act's requirements make it likely the SPADEs will be considered
for use in future adjustments. The commenters urged CMS to be
circumspect and transparent in its approaches to incorporating the data
elements proposed in payment and quality adjustments, such as by
collecting stakeholder feedback before implementing any adjustments.
    Response: We thank the commenters for recognizing that collecting
SDOH data elements can be useful in identifying and addressing health
disparities. As provided in the FY 2020 SNF PPS proposed rule (84 FR
17672), accessing standardized data relating to the SDOH data elements
on a national level is necessary to permit us to conduct periodic
analyses, to assess appropriate adjustments to quality measures,
resource use and other measures, and to assess and implement
appropriate adjustments to Medicare payments based on those measures.
Additionally, these data will also permit us to develop the statistical
tools necessary to maximize the value of Medicare data, reduce costs,
and improve the quality of care for all beneficiaries. We will continue
to work with stakeholders to promote transparency and support providers
who serve vulnerable populations, promote high quality care, and refine
and further implement SDOH SPADE to meet the IMPACT Act requirements.
We appreciate the comment on collecting stakeholder feedback before
implementing any adjustments to measures based on the SDOH SPADE.
Collection of this data will help us in identifying potential
disparities, conducting analyses, and assessing whether any adjustments
are needed. Any future policy development based on this data would be
done transparently, and involve solicitation of stakeholder feedback
through the notice and comment rulemaking process as appropriate.
    Comment: One commenter supported the proposal to collect
information on the seven proposed SDOH SPADE data elements. However,
the commenter suggested that it is important to include metrics to
determine if a resident is low-income in the SNF QRP SPADEs. The
commenter referenced the ASPE report to Congress in 2016 that noted
Medicare beneficiaries with social risk factors have worse outcomes on
many quality measures; therefore, the commenter urged CMS to
incorporate risk adjustment for sociodemographic and socioeconomic
status into the appropriate SNF QRP and SNF VBP performance measures.
The commenter also recommended that CMS closely monitor the effects of
its quality improvement initiatives on low-income communities to ensure
that resources are not being driven away from these communities to more
affluent communities solely on the basis of comparatively higher
quality scores and consider new initiatives that provide incentives
specifically targeted at reducing identified disparities.
    Response: We appreciate the commenter's support. We understand the
commenters concern that CMS ensure that the new SDOH data elements not
negatively impact the resources of low-income communities and would
note that at this time we did not propose using SDOH SPADEs for risk
adjustment as part of this rulemaking. We will consider the commenter's
feedback in future policy making, including in regard to risk
adjustment, and as we monitor the effects of our quality improvement
initiatives.
    Comment: Several commenters recommended that CMS include
[[Page 38809]]
disability status as a SDOH that contributes to overall patient access
to care, health status, outcomes, and many other determinants of health
since it is already included in some Medicare risk adjustment. The
commenters stated that ASPE's report to Congress entitled ``Social Risk
Factors and Performance Under Medicare's Value-Based Purchasing
Programs'' reported that disability is an independent predictor of poor
mental and physical health outcomes, and that individuals with
disabilities may receive lower-quality preventive care.
    Response: We appreciate the comments and suggestions provided by
the commenters, and we agree that it is important to understand the
needs of patients with disabilities. While disability is not being
currently assessed through the SPADE, it is comprehensively assessed as
part of existing protocols around care plans and health goals. However,
as we continue to evaluate SDOH SPADEs, we will keep commenters'
feedback in mind and may consider these suggestions in future
rulemaking.
    Comment: One commenter supported the use of the seven proposed SDOH
data elements and suggested that CMS explore assessing if a patient has
a family or caregiver and whether they are competent. They suggested
this should be assessed since the health and capability of the family
caregiver for someone with advanced illness can have a significant
impact on their health and medical interventions.
    Response: Thank you for the comment. We had to balance the
importance of new SDOH data elements with the potential burden of
adding more SDOH data elements to the assessment, beyond the seven that
were selected. We will consider this feedback as we continue to improve
and refine the SPADEs.
(i) Race and Ethnicity
    The persistence of racial and ethnic disparities in health and
health care is widely documented, including in PAC
settings.153 154 155 156 157 Despite the trend toward
overall improvements in quality of care and health outcomes, the Agency
for Healthcare Research and Quality, in its National Healthcare Quality
and Disparities Reports, consistently indicates that racial and ethnic
disparities persist, even after controlling for factors such as income,
geography, and insurance.\158\ For example, racial and ethnic
minorities tend to have higher rates of infant mortality, diabetes and
other chronic conditions, and visits to the emergency department, and
lower rates of having a usual source of care and receiving
immunizations such as the flu vaccine.\159\ Studies have also shown
that African Americans are significantly more likely than white
Americans to die prematurely from heart disease and stroke.\160\
However, our ability to identify and address racial and ethnic health
disparities has historically been constrained by data limitations,
particularly for smaller populations groups such as Asians, American
Indians and Alaska Natives, and Native Hawaiians and other Pacific
Islanders.\161\
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    \153\ 2017 National Healthcare Quality and Disparities Report.
Rockville, MD: Agency for Healthcare Research and Quality; September
2018. AHRQ Pub. No. 18-0033-EF.
    \154\ Fiscella, K. and Sanders, M.R. Racial and Ethnic
Disparities in the Quality of Health Care. (2016). Annual Review of
Public Health. 37:375-394.
    \155\ 2018 National Impact Assessment of the Centers for
Medicare & Medicaid Services (CMS) Quality Measures Reports.
Baltimore, MD: U.S. Department of Health and Human Services, Centers
for Medicare and Medicaid Services; February 28, 2018.
    \156\ Smedley, B.D., Stith, A.Y., & Nelson, A.R. (2003). Unequal
treatment: Confronting racial and ethnic disparities in health care.
Washington, DC, National Academy Press.
    \157\ Chase, J., Huang, L. and Russell, D. (2017). Racial/ethnic
disparities in disability outcomes among post-acute home care
patients. J of Aging and Health. 30(9):1406-1426.
    \158\ National Healthcare Quality and Disparities Reports.
(December 2018). Agency for Healthcare Research and Quality,
Rockville, MD. http://www.ahrq.gov/research/findings/nhqrdr/index.html.
    \159\ National Center for Health Statistics. Health, United
States, 2017: With special feature on mortality. Hyattsville,
Maryland. 2018.
    \160\ HHS. Heart disease and African Americans. 2016b. (October
24, 2016). http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
    \161\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Population Health and Public
Health Practice; Committee on Community-Based Solutions to Promote
Health Equity in the United States; Baciu A, Negussie Y, Geller A,
et al., editors. Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The
State of Health Disparities in the United States. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
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    The ability to improve understanding of and address racial and
ethnic disparities in PAC outcomes requires the availability of better
data. There is currently a Race and Ethnicity data element, collected
in the MDS, LCDS, IRF-PAI, and OASIS, that consists of a single
question, which aligns with the 1997 Office of Management and Budget
(OMB) minimum data standards for federal data collection efforts.\162\
The 1997 OMB Standard lists five minimum categories of race: (1)
American Indian or Alaska Native; (2) Asian; (3) Black or African
American; (4) Native Hawaiian or Other Pacific Islander; (5) and White.
The 1997 OMB Standard also lists two minimum categories of ethnicity:
(1) Hispanic or Latino, and (2) Not Hispanic or Latino. The 2011 HHS
Data Standards requires a two-question format when self-identification
is used to collect data on race and ethnicity. Large federal surveys
such as the National Health Interview Survey, Behavioral Risk Factor
Surveillance System, and the National Survey on Drug Use and Health,
have implemented the 2011 HHS race and ethnicity data standards. CMS
has similarly updated the Medicare Current Beneficiary Survey, Medicare
Health Outcomes Survey, and the Health Insurance Marketplace
Application for Health Coverage with the 2011 HHS data standards. More
information about the HHS Race and Ethnicity Data Standards are
available on the website at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
---------------------------------------------------------------------------
    \162\ ``Revisions to the Standards for the Classification of
Federal Data on Race and Ethnicity (Notice of Decision)''. Federal
Register 62:210 (October 30, 1997) pp. 58782-58790. Available from:
https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf.
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    We proposed to revise the current Race and Ethnicity data element
for purposes of this proposal to conform to the 2011 HHS Data Standards
for person-level data collection, while also meeting the 1997 OMB
minimum data standards for race and ethnicity. Rather than one data
element that assesses both race and ethnicity, we proposed two separate
data elements: one for Race and one for Ethnicity, that would conform
with the 2011 HHS Data Standards and the 1997 OMB Standard. In
accordance with the 2011 HHS Data Standards, a two-question format
would be used for the proposed race and ethnicity data elements.
    The proposed Race data element asks, ``What is your race?'' We
proposed to include fourteen response options under the race data
element: (1) White; (2) Black or African American; (3) American Indian
or Alaska Native; (4) Asian Indian; (5) Chinese; (6) Filipino; (7)
Japanese; (8) Korean; (9) Vietnamese; (10) Other Asian; (11) Native
Hawaiian; (12) Guamanian or Chamorro; (13) Samoan; and, (14) Other
Pacific Islander.
    The proposed Ethnicity data element asks, ``Are you of Hispanic,
Latino/a, or Spanish origin?'' We proposed to include five response
options under the ethnicity data element: (1) Not of Hispanic, Latino/
a, or Spanish origin; (2) Mexican, Mexican American, Chicano/a; (3)
Puerto Rican; (4) Cuban; and, (5) Another Hispanic, Latino, or Spanish
Origin. We are including the addition of ``of'' to the Ethnicity data
[[Page 38810]]
element to read, ``Are you of Hispanic, Latino/a, or Spanish origin?''
    We believe that the two proposed data elements for race and
ethnicity conform to the 2011 HHS Data Standards for person-level data
collection, while also meeting the 1997 OMB minimum data standards for
race and ethnicity, because under those standards, more detailed
information on population groups can be collected if those additional
categories can be aggregated into the OMB minimum standard set of
categories.
    In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the importance of improving response
options for race and ethnicity as a component of health care
assessments and for monitoring disparities. Some stakeholders
emphasized the importance of allowing for self-identification of race
and ethnicity for more categories than are included in the 2011 HHS
Standard to better reflect state and local diversity, while
acknowledging the burden of coding an open-ended health care assessment
question across different settings.
    We believe that the proposed modified race and ethnicity data
elements more accurately reflect the diversity of the U.S. population
than the current race/ethnicity data element included in MDS, LCDS,
IRF-PAI and, OASIS.163 164 165 166 We believe, and research
consistently shows, that improving how race and ethnicity data are
collected is an important first step in improving quality of care and
health outcomes. Addressing disparities in access to care, quality of
care, and health outcomes for Medicare beneficiaries begins with
identifying and analyzing how SDOH, such as race and ethnicity, align
with disparities in these areas.\167\ Standardizing self-reported data
collection for race and ethnicity allows for the equal comparison of
data across multiple healthcare entities.\168\ By collecting and
analyzing these data, CMS and other healthcare entities will be able to
identify challenges and monitor progress. The growing diversity of the
US population and knowledge of racial and ethnic disparities within and
across population groups supports the collection of more granular data
beyond the 1997 OMB minimum standard for reporting categories. The 2011
HHS race and ethnicity data standard includes additional detail that
may be used by PAC providers to target quality improvement efforts for
racial and ethnic groups experiencing disparate outcomes. For more
information on the Race and Ethnicity data elements, we refer readers
to the document titled ``Proposed Specifications for SNF QRP Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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    \163\ Penman-Aguilar, A., Talih, M., Huang, D., Moonesinghe, R.,
Bouye, K., Beckles, G. (2016). Measurement of Health Disparities,
Health Inequities, and Social Determinants of Health to Support the
Advancement of Health Equity. J Public Health Manag Pract. 22 Suppl
1: S33-42.
    \164\ Ramos, R., Davis, J.L., Ross, T., Grant, C.G., Green, B.L.
(2012). Measuring health disparities and health inequities: Do you
have REGAL data? Qual Manag Health Care. 21(3):176-87.
    \165\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
    \166\ ``Revision of Standards for Maintaining, Collecting, and
Presenting Federal Data on Race and Ethnicity: Proposals From
Federal Interagency Working Group (Notice and Request for
Comments).'' Federal Register 82: 39 (March 1, 2017) p. 12242.
    \167\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Population Health and Public
Health Practice; Committee on Community-Based Solutions to Promote
Health Equity in the United States; Baciu A, Negussie Y, Geller A,
et al., editors. Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The
State of Health Disparities in the United States. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
    \168\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
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    In an effort to standardize the submission of race and ethnicity
data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in
section 1899B(a)(1)(B) of the Act, while minimizing the reporting
burden, we proposed to adopt the Race and Ethnicity data elements
described above as SPADEs with respect to the proposed Social
Determinants of Health category.
    Specifically, we proposed to replace the current Race/Ethnicity
data element with the proposed Race and Ethnicity data elements on the
MDS. We also proposed that SNFs that submit the Race and Ethnicity data
elements with respect to admission will be considered to have submitted
with respect to discharge as well, because it is unlikely that the
results of these assessment findings will change between the start and
end of the SNF stay, making the information submitted with respect to a
resident's admission the same with respect to a resident's discharge.
    We solicited comment on these proposals.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Race and Ethnicity SPADEs. A discussion of
these comments, along with our responses, appears below.
    Comment: Some commenters noted that the response options for race
do not align with those used in other government data, such as the U.S.
Census or the Office of Management and Budget (OMB). The commenters
also stated these responses are not consistent with the recommendations
made in the 2009 Institute of Medicine (IOM) report. The commenters
pointed out that IOM report recommended using broader OMB race
categories and granular ethnicities chosen from a national standard set
that can be ``rolled up'' into the broader categories. The commenters
stated that it is unclear how CMS chose the 14 response options under
the race data element and the five options under the ethnicity element
and worried that these response options would add to the confusion that
already may exist for patients about what terms like ``race'' and
``ethnicity'' mean for the purposes of health care data collection. The
commenters also noted that CMS should confer directly with experts in
the issue to ensure patient assessments are collecting the right data
in the right way before these SDOH SPADEs are finalized. One commenter
also suggested that in lieu of data collection on Race/Ethnicity,
collection of cultural information such as End of Life decisions,
cultural holidays, celebrations or ceremonies, and other cultural norms
is much more valuable for patient care outcomes and care delivery.
    Response: The proposed Race and Ethnicity categories align with and
are rolled up into the 1997 OMB minimum data standards and conforming
with the 2011 HHS Data Standards as described in the implementation
guidance titled ``U.S. Department of Health and Human Services
Implementation Guidance on Data Collection Standards for Race,
Ethnicity, Sex, Primary Language, and Disability Status'' at https://aspe.hhs.gov/basic-report/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-and-disability-status. As
stated in the proposed rule, the 14 race categories and the 5 ethnicity
categories conform with the 2011 HHS Data Standards for person-level
data collection, which were developed in fulfillment of section 4302 of
the Affordable Care Act that required the Secretary of HHS to establish
data collection standards for race, ethnicity, sex, primary language,
and disability
[[Page 38811]]
status. Through the HHS Data Council, which is the principal, senior
internal Departmental forum and advisory body to the Secretary on
health and human services data policy and coordinates HHS data
collection and analysis activities, the Section 4302 Standards
Workgroup was formed. The Workgroup included representatives from HHS,
the OMB, and the Census Bureau. The Workgroup examined current federal
data collection standards, adequacy of prior testing, and quality of
the data produced in prior surveys; consulted with statistical agencies
and programs; reviewed OMB data collection standards and the Institute
of Medicine (IOM) Report Race, Ethnicity, and Language Data Collection:
Standardization for Health Care Quality Improvement; sought input from
national experts; and built on its members' experience with collecting
and analyzing demographic data. As a result of this Workgroup, a set of
data collection standards were developed, and then published for public
comment. This set of data collection standards is referred to as the
2011 HHS Data Standards.\169\ The categories of race and ethnicity
under the 2011 HHS Data Standards allow for more detailed information
to be collected and the additional categories under the 2011 HHS Data
Standards can be aggregated into the OMB minimum standards set of
categories.
---------------------------------------------------------------------------
    \169\ HHS Data Standards. Available at https://aspe.hhs.gov/basic-report/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-and-disability-status.
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    As noted in the FY 2020 SNF PPS proposed rule (84 FR 17672 through
17675), CMS conferred with experts by conducting a listening session
regarding the proposed SDOH data elements regarding the importance of
improving response options for race and ethnicity as a component of
health care assessments and for monitoring disparities. Some
stakeholders emphasized the importance of allowing for self-
identification of race and ethnicity for more categories than are
included in the 2011 HHS Data Standards to better reflect state and
local diversity.
    Collecting Race/Ethnicity is important for evaluating the impact
that SDOHs have on health outcomes. Because of this, CMS will collect
Race/Ethnicity instead of replacing these data element with the
collection of cultural information such as End of Life decisions,
cultural holidays, celebrations or ceremonies, and other cultural
norms.
    Comment: A commenter supported the opportunities to better account
for SDOH in the diagnosis and treatment of patients but was concerned
by the specificity of several of the seven proposed element for data
collection for example, collection of race by Japanese, Chinese,
Korean, etc. The commenter's concern was with the added burden in
collecting the level of specificity outlined, and they requested that
CMS provide more detailed guidance in the final rule regarding how this
information should be collected and shared in compliance with HIPAA.
Further, the commenter requested that the agency outlines its
expectations for how this newly collected information will be used by
Medicare for payment and public reporting.
    Response: For the Race and Ethnicity SPADE data element, this data
should be completed based on the response of the patient, which is
considered the gold standard of assessing race and ethnicity. It is
important ask the patient to select the category or categories that
most closely correspond to their race and ethnicity. Respondents should
be offered the option of selecting one or more race and ethnicity
categories. Observer identification or medical record documentation may
not be used.
    Finally, as provided in the FY 2020 SNF PPS proposed rule (84 FR
17671through 17672), accessing standardized data relating to the SDOH
data elements on a national level is necessary to permit CMS to conduct
periodic analyses, to assess appropriate adjustments to quality
measures, resource use and other measures, and to assess and implement
appropriate adjustments to Medicare payments based on those measures.
Any potential future use of the data for payment and public reporting
purposes would be done through rulemaking.
    SDOH Data elements should be treated the same as other information
currently collected on the assessment tool. As to any specific HIPAA
question, we appreciate the commenter's commitment to compliance with
the HIPAA requirements, but note that the Office for Civil Rights (OCR)
is tasked with implementing and enforcing HIPAA, not CMS. Commenters
should consult appropriate counsel in instances in which they are
unsure of their HIPAA status, or the permissibility of a disclosure
under the HIPAA Privacy Rule. In doing so, commenters may wish to
consult 45 CFR 164.103 (definition of ``required by law'') and
164.512(a) (allowing ``required by law'' disclosures).
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Race data element as SPADE as
proposed, and the Ethnicity data element as SPADE with the addition of
one technical change discussed above, beginning with the FY 2022 SNF
QRP.
(ii) Preferred Language and Interpreter Services
    More than 64 million Americans speak a language other than English
at home, and nearly 40 million of those individuals have limited
English proficiency (LEP).\170\ Individuals with LEP have been shown to
receive worse care and have poorer health outcomes, including higher
readmission rates.171 172 173 Communication with individuals
with LEP is an important component of high quality health care, which
starts by understanding the population in need of language services.
Unaddressed language barriers between a patient and provider care team
negatively affects the ability to identify and address individual
medical and non-medical care needs, to convey and understand clinical
information, as well as discharge and follow up instructions, all of
which are necessary for providing high quality care. Understanding the
communication assistance needs of residents and patients with LEP,
including individuals who are Deaf or hard of hearing, is critical for
ensuring good outcomes.
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    \170\ U.S. Census Bureau, 2013-2017 American Community Survey 5-
Year Estimates.
    \171\ Karliner LS, Kim SE, Meltzer DO, Auerbach AD. Influence of
language barriers on outcomes of hospital care for general medicine
inpatients. J Hosp Med. 2010 May-Jun;5(5):276-82. doi: 10.1002/
jhm.658.
    \172\ Kim EJ, Kim T, Paasche-Orlow MK, et al. Disparities in
Hypertension Associated with Limited English Proficiency. J Gen
Intern Med. 2017 Jun;32(6):632-639. doi: 10.1007/s11606-017-3999-9.
    \173\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Washington, DC: The National
Academies Press.
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    Presently, the preferred language of residents and patients and
need for interpreter services are assessed in two PAC assessment tools.
The LCDS and the MDS use the same two data elements to assess preferred
language and whether a patient or resident needs or wants an
interpreter to communicate with health care staff. The MDS initially
implemented preferred language and interpreter services data elements
to assess the needs of SNF residents and patients and inform care
planning. For alignment purposes, the LCDS later adopted the same data
elements for LTCHs. The 2009 NASEM (formerly Institute of Medicine)
report on standardizing data for health care quality improvement
emphasizes that language and communication needs
[[Page 38812]]
should be assessed as a standard part of health care delivery and
quality improvement strategies.\174\
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    \174\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
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    In developing our proposal for a standardized language data element
across PAC settings, we considered the current preferred language and
interpreter services data elements that are in LCDS and MDS. We also
considered the 2011 HHS Primary Language Data Standard and peer-
reviewed research. The current preferred language data element in LCDS
and MDS asks, ``What is your preferred language?'' Because the
preferred language data element is open-ended, the patient or resident
is able to identify their preferred language, including American Sign
Language (ASL). Finally, we considered the recommendations from the
2009 NASEM (formerly Institute of Medicine) report, ``Race, Ethnicity,
and Language Data: Standardization for Health Care Quality
Improvement.'' In it, the committee recommended that organizations
evaluating a patient's language and communication needs for health care
purposes, should collect data on the preferred spoken language and on
an individual's assessment of his/her level of English proficiency.
    A second language data element in LCDS and MDS asks, ``Do you want
or need an interpreter to communicate with a doctor or health care
staff?'' and includes yes or no response options. In contrast, the 2011
HHS Primary Language Data Standard recommends either a single question
to assess how well someone speaks English or, if more granular
information is needed, a two-part question to assess whether a language
other than English is spoken at home and if so, identify that language.
However, neither option allows for a direct assessment of a patient's
or resident's preferred spoken or written language nor whether they
want or need interpreter services for communication with a doctor or
care team, both of which are an important part of assessing resident
and patient needs and the care planning process. More information about
the HHS Data Standard for Primary Language is available on the website
at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
    Research consistently recommends collecting information about an
individual's preferred spoken language and evaluating those responses
for purposes of determining language access needs in health care.\175\
However, using ``preferred spoken language'' as the metric does not
adequately account for people whose preferred language is ASL, which
would necessitate adopting an additional data element to identify
visual language. The need to improve the assessment of language
preferences and communication needs across PAC settings should be
balanced with the burden associated with data collection on the
provider and patient or resident. Therefore we proposed to retain the
Preferred Language and Interpreter Services data elements currently in
use on the MDS.
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    \175\ Guerino, P. and James, C. Race, Ethnicity, and Language
Preference in the Health Insurance Marketplaces 2017 Open Enrollment
Period. Centers for Medicare & Medicaid Services, Office of Minority
Health. Data Highlight: Volume 7--April 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf.
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    In addition, we received feedback during the December 13, 2018
listening session on the importance of evaluating and acting on
language preferences early to facilitate communication and allowing for
patient self-identification of preferred language. Although the
discussion about language was focused on preferred spoken language,
there was general consensus among participants that stated language
preferences may or may not accurately indicate the need for interpreter
services, which supports collecting and evaluating data to determine
language preference, as well as the need for interpreter services. An
alternate suggestion was made to inquire about preferred language
specifically for discussing health or health care needs. While this
suggestion does allow for ASL as a response option, we do not have data
indicating how useful this question might be for assessing the desired
information and thus we are not including this question in our
proposal.
    Improving how preferred language and need for interpreter services
data are collected is an important component of improving quality by
helping PAC providers and other providers understand patient needs and
develop plans to address them. For more information on the Preferred
Language and Interpreter Services data elements, we refer readers to
the document titled ``Proposed Specifications for SNF QRP Measures and
Standardized Patient Assessment Data Elements,'' available on the
website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of language data among
IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
proposed to adopt the Preferred Language and Interpreter Services data
elements currently used on the MDS, and describe above, as SPADEs with
respect to the Social Determinants of Health category.
    We solicited comment on these proposals.
    Commenters submitted the following comments related to the proposed
rule's discussion of Preferred Language and Interpreter Services
SPADEs. A discussion of these comments, along with our responses,
appears below.
    Comment: Some commenters noted that, if finalized, SNFs only would
need to submit data on the race and ethnicity SPADEs with respect to
admission and would not need to collect and report again at discharge,
as it is unlikely that patient status for these elements will change.
The commenters believe that a patient's preferred language and need for
an interpreter also are unlikely to change between admission and
discharge; thus, the commenter urged CMS to deem SNFs that submit data
with respect to admission for these SDOH SPADEs to have submitted with
respect to both admission and discharge.
    Response: We thank the commenters for the comment. With regard to
the submission of the Preferred Language and the Interpreter Services
SPADE, we agree with the commenters that it is unlikely that the
assessment of Preferred Language and Interpreter Services at admission
would differ from assessment at discharge. As discussed in previous
response for Vision and Hearing, we believe that the submission of
preferred language and the need for an interpreter is similar to the
submission of Race, Ethnicity, Hearing, and Vision SPADEs.
    In response to commenters' feedback, we are finalizing that SNFs
that submit the Preferred Language and Interpreter Services SPADES with
respect to admission will be deemed to have submitted with respect to
both admission and discharge.
    Based on the comments received, and for the reasons discussed, we
are finalizing that the Preferred Language and Interpreter Services
SPADEs be collected with the modification that we will deem SNFs that
submit these two SPADEs with respect to admission to have submitted
with respect to discharge as well.
[[Page 38813]]
(iii) Health Literacy
    The Department of Health and Human Services defines health literacy
as ``the degree to which individuals have the capacity to obtain,
process, and understand basic health information and services needed to
make appropriate health decisions.'' \176\ Similar to language
barriers, low health literacy can interfere with communication between
the provider and resident or patient and the ability for residents and
patients or their caregivers to understand and follow treatment plans,
including medication management. Poor health literacy is linked to
lower levels of knowledge about health, worse health outcomes, and the
receipt of fewer preventive services, but higher medical costs and
rates of emergency department use.\177\
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    \176\ U.S. Department of Health and Human Services, Office of
Disease Prevention and Health Promotion. National action plan to
improve health literacy. Washington (DC): Author; 2010.
    \177\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Washington, DC: The National
Academies Press.
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    Health literacy is prioritized by Healthy People 2020 as an
SDOH.\178\ Healthy People 2020 is a long-term, evidence-based effort
led by the Department of Health and Human Services that aims to
identify nationwide health improvement priorities and improve the
health of all Americans. Although not designated as a social risk
factor in NASEM's 2016 report on accounting for social risk factors in
Medicare payment, the NASEM noted that health literacy is impacted by
other social risk factors and can affect access to care as well as
quality of care and health outcomes.\179\ Assessing for health literacy
across PAC settings would facilitate better care coordination and
discharge planning. A significant challenge in assessing the health
literacy of individuals is avoiding excessive burden on patients and
residents and health care providers. The majority of existing,
validated health literacy assessment tools use multiple screening
items, generally with no fewer than four, which would make them
burdensome if adopted in MDS, LCDS, IRF-PAI, and OASIS.
---------------------------------------------------------------------------
    \178\ Social Determinants of Health. Healthy People 2020.
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
    \179\ U.S. Department of Health & Human Services, Office of the
Assistant Secretary for Planning and Evaluation. Report to Congress:
Social Risk Factors and Performance Under Medicare's Value-Based
Purchasing Programs. Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs. Washington, DC: 2016.
---------------------------------------------------------------------------
    The Single Item Literacy Screener (SILS) question asks, ``How often
do you need to have someone help you when you read instructions,
pamphlets, or other written material from your doctor or pharmacy?''
Possible response options are: (1) Never; (2) Rarely; (3) Sometimes;
(4) Often; and (5) Always. The SILS question, which assesses reading
ability, (a primary component of health literacy), tested reasonably
well against the 36 item Short Test of Functional Health Literacy in
Adults (S-TOFHLA), a thoroughly vetted and widely adopted health
literacy test, in assessing the likelihood of low health literacy in an
adult sample from primary care practices participating in the Vermont
Diabetes Information System.180 181 The S-TOFHLA is a more
complex assessment instrument developed using actual hospital related
materials such as prescription bottle labels and appointment slips, and
often considered the instrument of choice for a detailed evaluation of
health literacy.\182\ Furthermore, the S-TOFHLA instrument is
proprietary and subject to purchase for individual entities or
users.\183\ Given that SILS is publicly available, shorter and easier
to administer than the full health literacy screen, and research found
that a positive result on the SILS demonstrates an increased likelihood
that an individual has low health literacy, we proposed to use the
single-item reading question for health literacy in the standardized
data collection across PAC settings. We believe that use of this data
element will provide sufficient information about the health literacy
of SNF residents to facilitate appropriate care planning, care
coordination, and interoperable data exchange across PAC settings.
---------------------------------------------------------------------------
    \180\ Morris, N.S., MacLean, C.D., Chew, L.D., & Littenberg, B.
(2006). The Single Item Literacy Screener: Evaluation of a brief
instrument to identify limited reading ability. BMC family practice,
7, 21. doi:10.1186/1471-2296-7-21.
    \181\ Brice, J.H., Foster, M.B., Principe, S., Moss, C., Shofer,
F.S., Falk, R.J., Ferris, M.E., DeWalt, D.A. (2013). Single-item or
two-item literacy screener to predict the S-TOFHLA among adult
hemodialysis patients. Patient Educ Couns. 94(1):71-5.
    \182\ University of Miami, School of Nursing & Health Studies,
Center of Excellence for Health Disparities Research. Test of
Functional Health Literacy in Adults (TOFHLA). (March 2019).
Available at https://elcentro.sonhs.miami.edu/research/measures-library/tofhla/index.html.
    \183\ Nurss, J.R., Parker, R.M., Williams, M.V., & Baker, D.W.,
David W. (2001). TOFHLA. Peppercorn Books & Press. Available from:
http://www.peppercornbooks.com/catalog/information.php?info_id=5.
---------------------------------------------------------------------------
    In addition, we received feedback during the December 13, 2018 SDOH
listening session on the importance of recognizing health literacy as
more than understanding written materials and filling out forms, as it
is also important to evaluate whether patients and residents understand
their conditions. However, the NASEM recently recommended that health
care providers implement health literacy universal precautions instead
of taking steps to ensure care is provided at an appropriate literacy
level based on individualized assessment of health literacy.\184\ Given
the dearth of Medicare data on health literacy and gaps in addressing
health literacy in practice, we recommend the addition of a health
literacy data element.
---------------------------------------------------------------------------
    \184\ Hudson, S., Rikard, R.V., Staiculescu, I. & Edison, K.
(2017). Improving health and the bottom line: The case for health
literacy. In Building the case for health literacy: Proceedings of a
workshop. Washington, DC: The National Academies Press.
---------------------------------------------------------------------------
    The proposed Health Literacy data element is consistent with
considerations raised by NASEM and other stakeholders and research on
health literacy, which demonstrates an impact on health care use, cost,
and outcomes.\185\ For more information on the proposed Health Literacy
data element, we refer readers to the document titled ``Proposed
Specifications for SNF QRP Measures and Standardized Patient Assessment
Data Elements,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
    \185\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for Social Risk Factors in Medicare Payment:
Identifying Social Risk Factors. Washington, DC: The National
Academies Press.
---------------------------------------------------------------------------
    In an effort to standardize the submission of health literacy data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
proposed to adopt the SILS question, described above for the Health
Literacy data element, as SPADE under the Social Determinants of Health
Category. We proposed to add the Health Literacy data element to the
MDS.
    We solicited comment on these proposals.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Health Literacy data element. A discussion of
these comments, along with our responses, appears below.
    Comment: Some commenters noted that, if finalized, SNFs should only
need
[[Page 38814]]
to submit data on the race and ethnicity SPADEs with respect to
admission and would not need to collect and report again at discharge,
as it is unlikely that patient status for these elements will change.
The commenters believe that a patient's health literacy is unlikely to
change between admission and discharge; thus, the commenter suggested
that CMS require collection of all SDOH SPADEs, including Health
Literacy, with respect to admission only.
    Response: We thank the commenters for their comments. We disagree
with the commenters that it is unlikely patient status for health
literacy will change from admission to discharge. Unlike the Vision,
Hearing, Race, Ethnicity, Preferred Language, and Interpreter Services
SPADEs, we believe that the response to this data element is likely to
change from admission to discharge for some patients. For example, some
patients may develop health issues, such as cognitive decline, during
their stay that could impact their response to health literacy thus
changing their status at discharged. Although not directly evaluated
for health literacy, clinical conditions that impact a patient's health
literacy status would be captured in the clinical record, even if they
are not assessed by a SPADE. Therefore, we proposed to collect this
SPADEs with respect to both admission and discharge.
    Comment: One commenter did not support the proposal to add health
literacy data element because the question focuses on whether an
individual may (or may not) have a literacy deficit, but fails to
identify the many reasons why a literacy deficit may exist, which the
commenter notes would be more valuable to patient care delivery and
patient care outcomes. The commenter also requested more clarification
on the connection between the frequencies in which an individual needs
assistance with reading in lieu of the reasons why an individual has a
literacy deficit.
    Response: As provided in the proposed rule (84 FR 17675 through
17676), low health literacy can interfere with communication between
the provider and patient and the ability for patients or their
caregivers to understand and follow treatment plans, including
medication management. Assessing for health literacy across PAC
settings would facilitate better care coordination and discharge
planning. While we agree that exploring the reasons for low health
literacy are important, we proposed the Health Literacy SPADE while
balancing the need to avoid excessive burden on patients and health
care providers, and we believe that a Health Literacy SPADE that
identifies reasons why a literacy deficit exists creates additional
burden on both the patients and the providers. The SILS Health Literacy
data element we proposed performed well when tested, and it minimizes
concerns related to burden by requiring one, instead of multiple,
questions on health literacy.186 187
---------------------------------------------------------------------------
    \186\ Morris, N.S., MacLean, C.D., Chew, L.D., & Littenberg, B.
(2006). The Single Item Literacy Screener: evaluation of a brief
instrument to identify limited reading ability. BMC family practice,
7, 21. doi:10.1186/1471-2296-7-21.
    \187\ Brice, J.H., Foster, M.B., Principe, S., Moss, C., Shofer,
F.S., Falk, R.J., Ferris, M.E., DeWalt, D.A. (2013). Single-item or
two-item literacy screener to predict the S-TOFHLA among adult
hemodialysis patients. Patient Educ Couns. 94(1):71-5.
---------------------------------------------------------------------------
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Health Literacy data element
as standardized patient assessment data beginning with the FY 2022 SNF
QRP as proposed.
(iv) Transportation
    Transportation barriers commonly affect access to necessary health
care, causing missed appointments, delayed care, and unfilled
prescriptions, all of which can have a negative impact on health
outcomes.\188\ Access to transportation for ongoing health care and
medication access needs, particularly for those with chronic diseases,
is essential to successful chronic disease management. Adopting a data
element to collect and analyze information regarding transportation
needs across PAC settings would facilitate the connection to programs
that can address identified needs. We are therefore proposing to adopt
as SPADE a single transportation data element that is from the Protocol
for Responding to and Assessing Patients' Assets, Risks, and
Experiences (PRAPARE) assessment tool and currently part of the
Accountable Health Communities (AHC) Screening Tool.
---------------------------------------------------------------------------
    \188\ Syed, S.T., Gerber, B.S., and Sharp, L.K. (2013).
Traveling Towards Disease: Transportation Barriers to Health Care
Access. J Community Health. 38(5): 976-993.
---------------------------------------------------------------------------
    The proposed Transportation data element from the PRAPARE tool
asks, ``Has lack of transportation kept you from medical appointments,
meetings, work, or from getting things needed for daily living?'' The
three response options are: (1) Yes, it has kept me from medical
appointments or from getting my medications; (2) Yes, it has kept me
from non-medical meetings, appointments, work, or from getting things
that I need; and (3) No. The patient or resident would be given the
option to select all responses that apply. We proposed to use the
transportation data element from the PRAPARE Tool, with permission from
National Association of Community Health Centers (NACHC), after
considering research on the importance of addressing transportation
needs as a critical SDOH.\189\
---------------------------------------------------------------------------
    \189\ Health Research & Educational Trust. (2017, November).
Social determinants of health series: Transportation and the role of
hospitals. Chicago, IL. Available at www.aha.org/transportation.www.aha.org/transportation.
---------------------------------------------------------------------------
    The proposed data element is responsive to research on the
importance of addressing transportation needs as a critical SDOH and
would adopt the Transportation item from the PRAPARE tool.\190\ This
data element comes from the national PRAPARE social determinants of
health assessment protocol, developed and owned by NACHC, in
partnership with the Association of Asian Pacific Community Health
Organization, the Oregon Primary Care Association, and the Institute
for Alternative Futures. Similarly the Transportation data element used
in the AHC Screening Tool was adapted from the PRAPARE tool. The AHC
screening tool was implemented by the Center for Medicare and Medicaid
Innovation's AHC Model and developed by a panel of interdisciplinary
experts that looked at evidence-based ways to measure SDOH, including
transportation. While the transportation access data element in the AHC
screening tool serves the same purposes as our proposed SPADE
collection about transportation barriers, the AHC tool has binary yes
or no response options that do not differentiate between challenges for
medical versus non-medical appointments and activities. We believe that
this is an important nuance for informing PAC discharge planning to a
community setting, as transportation needs for non-medical activities
may differ than for medical activities and should be taken into
account.\191\ We believe that use of this data element will provide
sufficient information about transportation barriers to medical and
non-medical care for SNF residents and patients to facilitate
appropriate discharge planning and care coordination across PAC
settings. As such, we proposed to adopt the Transportation data element
from
[[Page 38815]]
PRAPARE. More information about development of the PRAPARE tool is
available on the website at https://protect2.fireeye.com/url?k=7cb6eb44-20e2f238-7cb6da7b-0cc47adc5fa2-1751cb986c8c2f8c&u=http://www.nachc.org/prapare.
---------------------------------------------------------------------------
    \190\ Health Research & Educational Trust. (2017, November).
Social determinants of health series: Transportation and the role of
hospitals. Chicago, IL. Available at www.aha.org/transportation.
    \191\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
---------------------------------------------------------------------------
    In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the impact of transportation
barriers on unmet care needs. While recognizing that there is no
consensus in the field about whether providers should have
responsibility for resolving patient transportation needs, discussion
focused on the importance of assessing transportation barriers to
facilitate connections with available community resources.
    Adding a Transportation data element to the collection of SPADE
would be an important step to identifying and addressing SDOH that
impact health outcomes and patient experience for Medicare
beneficiaries. For more information on the Transportation data element,
we refer readers to the document titled ``Proposed Specifications for
SNF QRP Measures and Standardized Patient Assessment Data Elements,''
available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of transportation data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
proposed to adopt the Transportation data element described above as
SPADE with respect to the Social Determinants of Health category. If
finalized as proposed, we would add the Transportation data element to
the MDS.
    We solicited comment on these proposals.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Transportation data element. A discussion of
these comments, along with our responses, appears below.
    Comment: One commenter supported the proposal to add the
Transportation data element to the MDS because they agreed that this
information is valuable to discharge planning and understanding the
outcomes of post discharge from an inpatient stay. The commenter
provided that transportation has been a long-standing barrier to health
care and quality of life for the elderly and that an increase in
financial or community resources would improve a patient's capacity to
comply with their discharge plan of care or their ability to stay
engaged in social activities.
    Response: We thank the commenter.
    Comment: One commenter requested that CMS consider the limited
resources in the community to assist patients in meeting their
transportation needs and requested that CMS consider using this data to
facilitate the increase in access to transportation services for the
elderly patients living in the community.
    Response: Thank you for the comment and we will consider this
feedback as we continue to improve and refine the SPADES.
    Comment: The commenters believe that a patient's access to
transportation is unlikely to change between admission and discharge;
thus, the commenter urged CMS to require collection of all SDOH SPADEs,
including Transportation, with respect to admission only.
    Response: We disagree with the commenters that stated that access
to transportation will always be the same from admission to discharge.
Unlike the Vision, Hearing, Race, Ethnicity, Preferred Language, and
Interpreter Services SPADEs, as previously discussed, we believe that
the response to this data element is likely to change from admission to
discharge for some patients. For example, a patient could lose a family
member or caregiver between admission and discharge, which could impact
his or her access to transportation and impact how the patient responds
to the access to transportation SPADE data element. Therefore, we
believe that the response to this SDOH data element is likely to change
from admission to discharge for some patients and we proposed to
collect this SPADE data element with respect to both admission and
discharge. As outlined in the FY 2020 SNF QRP proposed rule, multiple
studies have demonstrated that access to transportation has an impact
on the health of patients (84 FR 17676 through 17677). Therefore, it is
important for providers to be able to identify a patient's needs when
the patient is admitted and when the patient is discharged in order to
better inform the patient's care decisions made during and after the
stay, including understanding the patient's unique risk factors and
treatment preferences. Because of this, we are keeping our proposal to
require SNFs to submit the Transportation data element at both
admission and discharge.
    After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Transportation data element as
standardized patient assessment data beginning with the FY 2022 SNF QRP
as proposed.
(v) Social Isolation
    Distinct from loneliness, social isolation refers to an actual or
perceived lack of contact with other people, such as living alone or
residing in a remote area. 192 193 Social isolation tends to
increase with age, is a risk factor for physical and mental illness,
and a predictor of mortality.194 195 196 Post-acute care
providers are well-suited to design and implement programs to increase
social engagement of patients and residents, while also taking into
account individual needs and preferences. Adopting a data element to
collect and analyze information about social isolation in SNFs and
across PAC settings would facilitate the identification of residents
and patients who are socially isolated and who may benefit from
engagement efforts.
---------------------------------------------------------------------------
    \192\ Tomaka, J., Thompson, S., and Palacios, R. (2006). The
Relation of Social Isolation, Loneliness, and Social Support to
Disease Outcomes Among the Elderly. J of Aging and Health. 18(3):
359-384.
    \193\ Social Connectedness and Engagement Technology for Long-
Term and Post-Acute Care: A Primer and Provider Selection Guide.
(2019). Leading Age. Available at https://www.leadingage.org/white-papers/social-connectedness-and-engagement-technology-long-term-and-post-acute-care-primer-and#1.1.
    \194\ Landeiro, F., Barrows, P., Nuttall Musson, E., Gray, A.M.,
and Leal, J. (2017). Reducing Social Loneliness in Older People: A
Systematic Review Protocol. BMJ Open. 7(5): e013778.
    \195\ Ong, A.D., Uchino, B.N.\,\ and Wethington, E. (2016).
Loneliness and Health in Older Adults: A Mini-Review and Synthesis.
Gerontology. 62:443-449.
    \196\ Leigh-Hunt, N., Bagguley, D., Bash, K., Turner, V.,
Turnbull, S., Valtorta, N., and Caan, W. (2017). An overview of
systematic reviews on the public health consequences of social
isolation and loneliness. Public Health. 152:157-171.
---------------------------------------------------------------------------
    We proposed to adopt as SPADE a single social isolation data
element that is currently part of the AHC Screening Tool. The AHC item
was selected from the Patient-Reported Outcomes Measurement Information
System (PROMIS[supreg]) Item Bank on Emotional Distress and asks, ``How
often do you feel lonely or isolated from those around you?'' The five
response options are: (1) Never; (2) Rarely; (3) Sometimes; (4) Often;
and (5) Always.\197\ The AHC Screening Tool was developed by a panel of
interdisciplinary experts that looked at evidence-based ways to measure
SDOH, including social isolation. More information about the AHC
Screening Tool is available on the website at https://
innovation.cms.gov/
[[Page 38816]]
Files/worksheets/ahcm-screeningtool.pdf.
---------------------------------------------------------------------------
    \197\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
---------------------------------------------------------------------------
    In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the value of receiving information
on social isolation for purposes of care planning. Some stakeholders
also recommended assessing social isolation as an SDOH as opposed to
social support.
    The proposed Social Isolation data element is consistent with NASEM
considerations about social isolation as a function of social
relationships that impacts health outcomes and increases mortality
risk, as well as the current work of a NASEM committee examining how
social isolation and loneliness impact health outcomes in adults 50
years and older. We believe that adding a Social Isolation data element
would be an important component of better understanding resident and
patient complexity and the care goals of residents and patients,
thereby facilitating care coordination and continuity in care planning
across PAC settings. For more information on the Social Isolation data
element, we refer readers to the document titled ``Proposed
Specifications for SNF QRP Measures and Standardized Patient Assessment
Data Elements,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of social isolation data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
proposed to adopt the Social Isolation data element described above as
SPADE with respect to the proposed Social Determinants of Health
category. We proposed to add the Social Isolation data element to the
MDS.
    We solicited comment on these proposals.
    Commenters submitted the following comments related to the proposed
rule's discussion the Social Isolation data element. A discussion of
these comments, along with our responses, appears below.
    Comment: One commenter did not support the proposal to add the
social isolation data element. The commenter provided that the MDS
currently collects data on mood using the Resident Mood Interview and
that the current data items in the Resident Mood Interview are
sufficient to adequately assess the resident's mood without adding
additional documentation requirements. The commenter also believed that
the existing interview is the beginning of a larger conversion that
often occurs between the resident and the interviewer. Additional
insight is also needed to understand the purpose of collecting this
information in addition to the existing mood questions. The commenter
requested that CMS consider that there are life events that may occur
in which it may be appropriate for an individual to feel lonely or
isolated.
    Response: As provided in the MDS, the intent of Resident Mood
Interview items is to ``address mood distress, a serious condition that
is underdiagnosed and undertreated in the nursing home and is
associated with significant morbidity. It is particularly important to
identify signs and symptoms of mood distress among nursing home
residents because these signs and symptoms can be treatable''. However,
the intent of the social isolation data element is not to assess how
the individual feels, but whether the individual feels connected to
those around them and can affect their mood. To collect and analyze
information about social isolation in SNFs and across PAC settings
would facilitate the identification of patients who are socially
isolated and who may benefit from engagement efforts. We appreciate the
suggestion from the commenter that CMS should consider that there are
life events that may occur in which it may be appropriate for an
individual to feel lonely or isolated and will take the suggestion
under consideration.
    Comment: One commenter supported the addition of SDOH to the
SPADEs, recognizing how these elements impact care use, cost and
outcomes for Medicare beneficiaries. The commenter believed that an
accurate understanding of the impact of SDOH is imperative and suggest
adding clarifiers to the SDOH measures for transportation and social
isolation. Adding a qualifying statement such as ``in your normal home
environment'' to each of the two data elements would help patients to
consider their normal daily living experiences rather than their acute
experiences of the hospital and post-acute care stays when answering
these questions.
    Response: We thank the commenter and we will consider this feedback
as we continue to improve and refine the SPADES.
    Comment: A commenter supported the addition of SDOH to the SPADEs
and noted that gathering these data will inform their understanding of
resident and patient complexity and risk factors that may affect
utilization of care, care outcomes and associated costs, and facilitate
better alignment of payments with the added challenges posed by SDOHs.
However, the commenter recommended adding a qualifier to the proposed
SDOH measure for Social Isolation to ensure the patient's response
reflects his/her home environment.
    Response: As we continue to evaluate SDOH SPADEs, we will keep this
in mind and will evaluate the addition of this qualifier.
    Comment: The commenters believe that a patient's response to social
isolation is unlikely to change between admission and discharge; thus,
the commenter urged CMS to require collection of all SDOH SPADEs,
including Social Isolation, with respect to admission only.
    Response: We disagree with the commenters that stated that the
response to the Social Isolation data element will be the same from
admission to discharge. Unlike the Vision, Hearing, Race, Ethnicity,
Preferred Language, and Interpreter Services SPADEs as discussed
previously, we believe that the response to this data element is likely
to change from admission to discharge for some patients. For example, a
patient could lose a family member or caregiver between admission and
discharge, which could impact their response to the Social Isolation
data element. Therefore, we proposed to collect this SPADE data element
with respect to both admission and discharge. As outlined in the FY
2020 SNF PPS proposed rule, multiple studies have demonstrated that
social isolation has an impact on the health of patients (84 FR 17677
through 17678). Therefore, we believe it is important for providers to
be able to identify a patient's needs when the patient is admitted and
when the patient is discharged in order to better inform the patient's
care decisions made during and after the stay, including understanding
the patient's unique risk factors and treatment preferences. Because of
this, we are requiring that the Social Isolation data element be
assessed at both admission and discharge.
    Based on the comments received, and for the reasons discussed, we
are finalizing our proposals for Social Isolation as proposed.
    After consideration of the public comments, we are finalizing our
proposals to collect SDOH data for the purposes under section
2(d)(2)(B) of the IMPACT Act and section 1899B(b)(1)(B)(vi) of the Act
as follows. We are finalizing our proposals for Race, Ethnicity, Health
Literacy,
[[Page 38817]]
Transportation, and Social Isolation as proposed. In response to
stakeholder comments, we are revising our proposed policies and
finalizing that SNFs that submit the Preferred Language and Interpreter
Services data elements SPADEs with respect to admission will be deemed
to have submitted with respect to both admission and discharge.
h. Form, Manner, and Timing of Data Submission Under the SNF QRP
(1) Background
    We refer readers to the regulatory text at Sec.  413.360(b) for
information regarding the current policies for reporting SNF QRP data.
(2) Update to the CMS System for Reporting Quality Measures and
Standardized Patient Assessment Data and Associated Procedural
Proposals
    SNFs are currently required to submit MDS data to CMS using the
Quality Improvement and Evaluation System (QIES) Assessment and
Submission Processing (ASAP) system. We will be migrating to a new
internet Quality Improvement and Evaluation System (iQIES) that will
enable real-time upgrades over the next few years, and we proposed to
designate that system as the data submission system for the SNF QRP
once it becomes available. In the proposed rule, we anticipated the
migration would occur no later than October 1, 2021. CMS can no longer
commit to this date based on the current development timeline
therefore, this migration will occur when technically feasible.
    We proposed to revise our regulatory text at Sec.  413.360(a) by
replacing ``Certification and Survey Provider Enhanced Reports
(CASPER)'' with ``CMS designated data submission''. We proposed to
revise our regulatory text at Sec.  413.360(d)(1) by replacing the
reference to the ``Quality Improvement Evaluation System (QIES)
Assessment Submission and Processing (ASAP)'' with ``CMS designated
data submission'' and Sec.  413.360(d)(4) by replacing the reference to
``QIES ASAP'' with ``CMS designated data submission'' effective October
1, 2019. We are correcting our proposal to revise Sec.  413.360(d)(4)
to remove the term ``system'' from ``CMS designated data submission
system''. In addition we proposed to notify the public of any future
changes to the CMS designated system using subregulatory mechanisms,
such as website postings, listserv messaging, and webinars.
    We invited public comments on this proposal.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Form, Manner, and Timing of Data Submission
under QRP. A discussion of these comments, along with our responses,
appears below.
    Comment: Several commenters noted support for the revisions to the
regulatory text to reflect the migration to the new iQIES system for
MDS data submission. One commenter further supported the proposal to
notify the public of any future changes to the CMS designated system
using subregulatory mechanisms. Another commenter suggested that CMS
increase the number of unique users per provider number that may have
access to the system, as the number of reports available and the number
of staff members utilizing these reports has increased.
    Response: We thank the commenters for their support, and would like
to take this opportunity to inform SNFs that users will no longer
require a virtual private network (VPN) or CMSNet to access iQIES so
providers will no longer have limited unique user ID's per provider.
    After considering the comments, we are finalizing the regulatory
text with the technical revision described above.
(3) Schedule for Reporting the Transfer of Health Information Quality
Measures Beginning With the FY 2022 SNF QRP
    As discussed in section III.E.1.d. of this final rule, we proposed
to adopt the Transfer of Health Information to Provider--Post-Acute
Care (PAC) and Transfer of Health Information to Patient--Post-Acute
Care (PAC) quality measures beginning with the FY 2022 SNF QRP. We also
proposed that SNFs would report the data on those measures using the
MDS. SNFs would be required to collect data on both measures for
residents beginning with October 1, 2020 discharges.
    We refer readers to the FY 2018 SNF PPS final rule (82 FR 36601
through 36603) for the data collection and submission time frames that
we finalized for the SNF QRP.
    We invited public comment on this proposal and did not receive any
comments.
    We are finalizing the schedule for our proposal that SNFs report
the data on Transfer of Health Information to the Provider--Post-Acute
Care (PAC) and Transfer of Health Information to the Patient--Post-
Acute Care (PAC) quality measures using the MDS as proposed. SNFs will
be required to collect data on both measures for residents beginning
with October 1, 2020 discharges for the FY 2022 SNF QRP.
(4) Schedule for Reporting Standardized Patient Assessment Data
Elements
    As discussed in section III.E.1.f. of this final rule, we proposed
to adopt SPADEs beginning with the FY 2022 SNF QRP. We proposed that
SNFs would report the data using the MDS. Similar to the proposed
schedule for reporting the Transfer of Health Information to the
Provider--Post-Acute Care (PAC) and Transfer of Health Information to
the Patient--Post-Acute Care (PAC) quality measures, SNFs would be
required to collect the SPADEs for residents beginning with October 1,
2020 admissions and discharges. SNFs that submit data with respect to
admission for the Hearing, Vision, Race, and Ethnicity would be
considered to have submitted data with respect to both admissions and
discharges. We refer readers to the FY 2018 SNF PPS final rule (82 FR
36601 through 36603) for the data collection and submission time frames
that we finalized for the SNF QRP.
    We invited public comment on this proposal. For a discussion of the
comments and responses we received regarding this proposal we refer the
reader to section III.E.1.f.
    After consideration of the comments received, we are finalizing our
proposal that SNFs must submit SPADEs for all patients discharged on or
after October 1, 2020, with respect to both admission and discharge,
using the MDS. SNFs that submit data with respect to admission for the
Hearing, Vision, Race, Ethnicity, Preferred Language, and Interpreter
Services SPADEs will be deemed to have submitted data with respect to
both admissions and discharges.
(5) Data Reporting on All Residents for the SNF Quality Reporting
Program Beginning With the FY 2022 SNF QRP
    We received public input suggesting that the quality measures used
in the SNF QRP should be calculated using data collected from all
residents receiving SNF services, regardless of the residents' payer.
This input was provided to us via comments requested about quality
measure development on the CMS Measures Management System Blueprint
website,\198\ the TEPs held by our measure development contractor,\199\
[[Page 38818]]
as well as through comments we received from stakeholders via our SNF
QRP mailbox, and feedback received from the NQF-convened Measure
Applications Partnership (MAP) as part of their recommendations on
Coordination Strategy for Post-Acute Care and Long-Term Care
Performance Measurement.\200\ Further, in the FY 2018 SNF PPS proposed
rule (82 FR 21077), we sought input on expanding the reporting of
quality data to include all residents, regardless of payer, so as to
ensure that the SNF QRP makes publicly available information regarding
the quality of the services furnished to the SNF population as a whole,
rather than just those residents who have Medicare.
---------------------------------------------------------------------------
    \198\ Public Comment Summary Report Posting for Transfer of
Health Information and Care Preferences. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Development-of-Cross-Setting-Transfer-of-Health-Information-Quality-Meas.pdf.
    \199\ Technical Expert Panel Summary Report: Development and
Maintenance of Quality Measures for Skilled Nursing Facility Quality
Reporting Program. April 2018. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/TEP-Summary-Report_April-2018_Development-and-Maintenance-of-Quality-Measures-for-SNF-QRP.pdf.
    \200\ MAP Coordination Strategy for Post-Acute Care and Long-
Term Care Performance Measurement. Feb 2012. http://www.qualityforum.org/Publications/2012/02/MAP_Coordination_Strategy_for_Post-Acute_Care_and_Long-Term_Care_Performance_Measurement.aspx.
---------------------------------------------------------------------------
    In response to that request for public input, several commenters,
including MedPAC, submitted comments stating that they would be
supportive of an effort to collect data specified under the SNF QRP
from all SNF residents regardless of their payer. Benefits highlighted
by commenters included that such data would serve to better inform
beneficiaries on the broader quality of the entire SNF, as well as more
comprehensive quality improvement efforts across payers. MedPAC also
highlighted that while the data collection activity incurs some cost,
some providers currently assess all residents routinely. For a more
detailed discussion we refer readers to the FY 2018 final rule (82 FR
36603 through 36604).
    Further, we believe that the most accurate representation of the
quality provided in SNFs to Medicare residents would be best conveyed
using data collected via the MDS on all SNF residents, regardless of
payer.
    Accordingly, we proposed that for purposes of meeting the
requirements of the SNF QRP, SNFs would be required to collect and
submit MDS data on all SNF residents regardless of their payer. We
believe that this will ensure that Medicare residents are receiving the
same quality of SNF care as other residents.
    While we appreciate that collecting quality data on all residents
regardless of payer may create additional burden, we are aware that
many SNFs currently collect MDS data on all residents, regardless of
their payer, and that some SNFs may consider it burdensome to separate
out Medicare beneficiaries from other residents for purposes of
submitting the assessments to CMS.
    We also note that collecting data on all SNF residents, regardless
of their payer, would align our data collection requirements under the
SNF QRP with the data collection requirements we have adopted for the
LTCH QRP and Hospice QRP.
    We proposed that, if finalized, this policy would be effective
beginning with the FY 2022 program year.
    We invited public comment on this proposal.
    Commenters submitted the following comments on the proposed Data
Reporting on Residents for the SNF Quality Reporting Program Beginning
with the FY 2022 SNF QRP. Below is a summary of the comments as well as
our responses.
    Comment: Several commenters expressed support for the collection of
data on all SNF residents regardless of payer. One commenter stated
that ensuring that the quality of care is not conditional based on
payer source is essential to the overall wellbeing of all SNF
residents. Another commenter stated that collecting data on all
patients regardless of payer is consistent with other quality programs.
This commenter noted that collecting data from all payers gives
consumers a more complete picture of quality of care within a SNF.
Similarly, another commenter stated that requiring SNFs to report data
on all patients regardless of payer would more accurately represent
quality of care within a SNF.
    Response: We thank the commenters for their support.
    Comment: One commenter requested that CMS delay implementation
until after FY 2022 SNF QRP to allow for added transition time for
adoption of the SPADEs. One commenter requested that CMS make this
requirement voluntary in the short-term. Several commenters expressed
concern for the collection of data on all SNF residents regardless of
payer and requested clarification on the details of this proposal
including which residents the required data collection pertained to,
the intended use of the data from payers other than Medicare, and how
this proposal would affect penalties for non-compliance in the SNF QRP.
One commenter questioned how this proposal would change the types and
number of assessments applicable to this requirement, and how CMS would
define which residents would be used to determine compliance with this
requirement. This commenter requested that CMS consider staffing
constraints and the technical complexity/coding rules required for
accurate completion of SNF QRP items and suggested that CMS provide
quarterly feedback via QIES that would display the SNF QRP all-payer
MDS data submission to allow providers an opportunity to ensure they
are meeting the data submission requirements or establish performance
improvement processes. Another commenter has long been concerned about
the attention to quality measurement for fee-for-service SNF patients
compared to the paucity of information on corresponding quality
measures regarding Medicare Advantage patients in a SNF, and suggested
Medicare Advantage patients be included in quality measures displayed
on Nursing Home Compare.
    Response: We appreciate the feedback we have received for the all
payer proposal and agree with the comments that providing clear policy
and implementation guidelines would be most appropriate for the
intended purposes of this proposal. We understand that more information
is needed to better understand which residents the required data
collection pertains to, the intended use of the data, and how this
proposal would affect penalties for non-compliance in the SNF QRP. We
acknowledge the feedback provided by some commenters with respect to
administrative challenges such as staffing, the assessments that would
be required for collection, the technicalities of coding, and the
desire for detailed policy and training. We understand the concerns
raised by commenters that more details for this proposal are needed in
order to better understand which residents the implementation of all
payer would affect. We recognize the commenters' concerns about this
proposal's implementation timeline and the implementation activities of
for the SPADEs. We would like to note that the implementation of the
SPADEs and the timeline proposed for this all payer proposal do not
overlap, and therefore we do not believe the implementation of the
SPADEs would have an effect on this proposal. Further, while we
appreciate the suggestion that CMS make this requirement voluntary in
the short-term, we believe that making this proposal a voluntary
requirement would not further the intent to conduct a meaningful
comparison of quality data. However, after consideration of the public
comments we received on these issues, we have decided that at this time
[[Page 38819]]
to not finalize the all payer proposal. Although we believe that the
reporting of all-payer data under the SNF QRP would add value to the
program and provide a more accurate representation of the quality
provided by SNFs, we believe we need to better quantify the new
reporting burden on SNFs there is from this proposal for stakeholders
to comment on. We agree that it would be useful to assess further how
to best implement the collection of data for all payers for the SNF
QRP. As part of this effort, we intend to further evaluate which
assessments are appropriate for reporting and define the population of
residents. We plan to propose to expand the reporting of MDS data used
for the SNF QRP to include data on all residents, regardless of their
payer, in future rulemaking.
    Comment: Some of the commenters expressed that this proposal would
present additional burden challenges for providers and suggested that
CMS conduct an analysis on the burden associated with collecting data
on all patients regardless of payer. One commenter believed this
proposal will add substantially to the reporting burden associated with
the SNF QRP, since facilities will be expected to respond to additional
questions on virtually all MDS assessments performed for a much larger
number of residents to meet QRP requirements. One commenter suggested
that collection of data on all payers would expand the use of the
assessment tool from the current Fee-for-Service (FFS) population to
patients covered by other payers and noted for CMS that significant
variation currently exists in SNFs for the percentage of patients
having the MDS 3.0 completed for the SNF QRP. This commenter identified
that the percentage may be high in some SNFs with a large portion of
FFS patients. In other SNFs, the greater portion of patients may be
covered by Medicare Advantage and SNFs may be completing other
assessments for other payers, particularly as it relates to payment
systems that continue to utilize older versions of the Resource
Utilization Group (RUG) system. One commenter stated they could only
support this proposal if the burden associated with the reporting
requirements is sufficiently funded.
    Response: We are sensitive to the issue of burden associated with
data collection and acknowledge the commenters' concerns about the
additional burden required to collect quality data on all residents. We
intend to identify and report the burden in future rulemaking when we
propose a new all-payer policy that addresses the concerns raised by
comments. Once these residents are identified, CMS would only require
data elements designated for the SNF QRP to be reported. To be clear,
many payment items are collected on the PPS admission and PPS discharge
assessments which would not be required to satisfy the proposal to
collect data on all SNF residents regardless of payer. While we have
acknowledged that collecting quality data on all residents regardless
of payer may create additional burden, we are aware that that many SNFs
currently collect MDS data on all residents for OBRA and other purposes
regardless of their payer, and that some SNFs may consider it
burdensome to separate out Medicare beneficiaries from other residents
for purposes of submitting the assessments to CMS. As stated prior, we
are not finalizing the all payer proposal, and we intend to identify
and report the burden in future rulemaking when we propose a new all-
payer policy that addresses the concerns raised by comments.
    We appreciate feedback we received from commenters on our proposal
to collect data on all SNF residents regardless of the resident's
payer. We believe that the collection of quality data to include all
residents would help to ensure that Medicare residents receive the same
quality of care as other residents who are treated by SNFs. We
appreciate the thoughtful questions and comments we received specific
to this proposal. Therefore, after careful consideration of the public
comments we received, we have decided not to finalize the proposal to
expand the reporting of SNF quality data to include all patients,
regardless of payer, at this time. We plan to use the input received in
this cycle of rulemaking to revise our policy and propose it in future
rulemaking whereby SNFs would be required to collect and submit MDS
data on all SNF residents regardless of their payer.
i. Policies Regarding Public Display of Measure Data for the SNF QRP
    Section 1899B(g) of the Act requires the Secretary to establish
procedures for making the SNF QRP data available to the public after
ensuring that SNFs have the opportunity to review their data prior to
public display. Measure data are currently displayed on the Nursing
Home Compare website, an interactive web tool that assists individuals
by providing information on SNF quality of care. For more information
on Nursing Home Compare, we refer readers to the website at https://www.medicare.gov/nursinghomecompare/search.html. For a more detailed
discussion about our policies regarding public display of SNF QRP
measure data and procedures for the opportunity to review and correct
data and information, we refer readers to the FY 2017 SNF PPS final
rule (81 FR 52045 through 52048).
    In the proposed rule, we proposed to begin publicly displaying data
for the Drug Regimen Review Conducted With Follow-Up for Identified
Issues--Post Acute Care (PAC) Skilled Nursing Facility (SNF) Quality
Reporting Program (QRP) measure beginning CY 2020 or as soon as
technically feasible. We finalized the Drug Regimen Review Conducted
With Follow-Up for Identified Issues--Post Acute Care (PAC) Skilled
Nursing Facility (SNF) Quality Reporting Program (QRP) measure in the
FY 2017 SNF PPS final rule (81 FR 52034 through 52039).
    Data collection for this assessment-based measure began with
patients admitted and discharged on or after October 1, 2018. We
proposed to display data based on four rolling quarters, initially
using discharges from January 1, 2019 through December 31, 2019
(Quarter 1 2019 through Quarter 4 2019). To ensure the statistical
reliability of the data, we proposed that we would not publicly report
a SNF's performance on the measure if the SNF had fewer than 20
eligible cases in any four consecutive rolling quarters. SNFs that have
fewer than 20 eligible cases would be distinguished with a footnote
that states, ``The number of cases/resident stays is too small to
publicly report''. We invited public comment on our proposal.
    Commenters submitted the following comments related to the proposed
rule's discussion of the Policies Regarding Public Display of Measure
Data for the SNF QRP. A discussion of these comments, along with our
responses, appears below.
    Comment: Several commenters supported the proposal to begin
publicly displaying data for the Drug Regimen Review Conducted With
Follow-Up for Identified Issues--Post Acute Care (PAC) Skilled Nursing
Facility (SNF) Quality Reporting Program (QRP) measure in CY 2020 or as
soon as technically feasible, including the exception for SNFs with
fewer than 20 eligible cases.
    Response: We appreciate the commenters support.
    After consideration of the public comments, we are finalizing our
proposal to begin publicly displaying data for the Drug Regimen Review
Conducted With Follow-Up for Identified Issues--Post Acute Care (PAC)
Skilled Nursing Facility (SNF)
[[Page 38820]]
Quality Reporting Program (QRP) measure beginning CY 2020 or as soon as
technically feasible.
2. Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP)
a. Background
    Section 215(b) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) authorized the SNF VBP Program (the
``Program'') by adding section 1888(h) to the Act. As a prerequisite to
implementing the SNF VBP Program, in the FY 2016 SNF PPS final rule (80
FR 46409 through 46426), we adopted an all-cause, all-condition
hospital readmission measure, as required by section 1888(g)(1) of the
Act and discussed other policies to implement the Program such as
performance standards, the performance period and baseline period, and
scoring. In the FY 2017 SNF PPS final rule (81 FR 51986 through 52009),
we adopted an all-condition, risk-adjusted potentially preventable
hospital readmission measure for SNFs, as required by section
1888(g)(2) of the Act, and adopted policies on performance standards,
performance scoring, and sought comment on an exchange function
methodology to translate SNF performance scores into value-based
incentive payments, among other topics. In the FY 2018 SNF PPS final
rule (82 FR 36608 through 36623), we adopted additional policies for
the Program, including an exchange function methodology for disbursing
value-based incentive payments. Additionally, in the FY 2019 SNF PPS
final rule (83 FR 39272 through 39282), we adopted more policies for
the Program, including a scoring adjustment for low-volume facilities.
    The SNF VBP Program applies to freestanding SNFs, SNFs affiliated
with acute care facilities, and all non-CAH swing-bed rural hospitals.
Section 1888(h)(1)(B) of the Act requires that the SNF VBP Program
apply to payments for services furnished on or after October 1, 2018.
We continue to believe the implementation of the SNF VBP Program is an
important step towards transforming how care is paid for, moving
increasingly towards rewarding better value, outcomes, and innovations
instead of merely rewarding volume.
    For additional background information on the SNF VBP Program,
including an overview of the SNF VBP Report to Congress and a summary
of the Program's statutory requirements, we refer readers to the FY
2016 SNF PPS final rule (80 FR 46409 through 46410). We also refer
readers to the FY 2017 SNF PPS final rule (81 FR 51986 through 52009)
for discussion of the policies that we adopted related to the
potentially preventable hospital readmission measure, scoring, and
other topics. We refer readers to the FY 2018 SNF PPS final rule (82 FR
36608 through 36623) for discussions of the policies that we adopted
related to value-based incentive payments, the exchange function, and
other topics. Finally, we refer readers to the FY 2019 SNF PPS final
rule (83 FR 39272 through 39282), where we adopted a corrections policy
for numerical values of performance standards, a scoring adjustment for
low-volume facilities, and addressed other topics.
    We received the following general comment on the SNF VBP Program.
    Comment: A commenter suggested that CMS consider recognizing
special patient populations, such as patients living with HIV/AIDS, for
purposes of the SNF VBP Program. The commenter suggested that we
incorporate states' recognition of special patient populations into the
SNF VBP Program in some way to ensure that SNFs that treat these
populations do not experience unintended consequences.
    Response: We appreciate the commenter's concern about special
populations. We would like to clarify that the readmission measure used
for this program is risk-adjusted to account for a SNF resident's
clinical characteristics, including HIV/AIDs, to ensure a fair
comparison across SNFs with different case-mixes. However, our
monitoring and evaluation activities for this program are intended, in
part, to ensure that the program does not cause unintended
consequences, and we will take this issue into consideration as we
conduct those activities.
b. Measures
(1) Background
    For background on the measures we have adopted for the SNF VBP
Program, we refer readers to the FY 2016 SNF PPS final rule (80 FR
46419), where we finalized the Skilled Nursing Facility 30-Day All-
Cause Readmission Measure (SNFRM) (NQF #2510) that we are currently
using for the SNF VBP Program. We also refer readers to the FY 2017 SNF
PPS final rule (81 FR 51987 through 51995), where we finalized the
Skilled Nursing Facility 30-Day Potentially Preventable Readmission
Measure (SNFPPR) that we will use for the SNF VBP Program instead of
the SNFRM as soon as practicable, as required by statute.
    We received the following general comments on the SNF VBP Program
measures.
    Comment: A commenter recommended that CMS incorporate risk
adjustment for socioeconomic status (SES) in the SNFRM to guard against
unduly penalizing facilities that predominantly serve very low-income
residents. The commenter acknowledged that the SNF VBP statute requires
a MedPAC study of SES effects on beneficiaries but stated that the
report that MedPAC will prepare for Congress will not be sufficient to
address the issue in the Program. The commenter specifically suggested
that CMS adjust the SNFRM for dual eligibility status as a proxy for
SES until better data are available.
    Response: The SNFRM was included in the initial phase of the
National Quality Forum (NQF) SES trial period, in which this and other
measures were assessed by NQF to determine if risk adjustment for SES
is appropriate for these measures. As part of this process, we tested
dual eligibilty as a potential risk-adjuster for the SNFRM and found
that it was associated with lower odds of readmission. We intend to
continue to monitor the effects of the SNF VBP Program on SNFs that
serve different types of populations and we will consider the MedPAC
report, which is due from MedPAC to Congress by June 30, 2021, as well
as ongoing stakeholder feedback, as we consider whether to incorporate
SES-based adjustments in the Program.
    Comment: A commenter stated that the SNFPPR measure's calculations
should not be based on the Statewide Planning and Research Cooperative
System (SPARCS) because that system is inaccessible to nursing home
providers. Commenter suggested that CMS explore a mechanism that would
have performance information readily accessible to nursing home
providers.
    Response: We would like to clarify that the SNF VBP Program
assesses SNF performance on a hospital readmission measure that is
calculated using Medicare fee-for-service claims data submitted to CMS
by acute care hospitals and SNFs. We do not use SPARCS data. We
appreciate the commenter's concern that SNFs may not have access to
all-payer state data; however, we use a different data source (Medicare
claims) and furnish quarterly confidential feedback reports to SNFs
that contain detailed data derived from Medicare claims data so that
all SNFs have access to the underlying data.
    Comment: A commenter requested that CMS work with Congress to
include additional measures beyond measures of hospital readmissions in
the SNF VBP Program. The commenter suggested that additional measures
could draw from
[[Page 38821]]
sources like Nursing Home Compare and from the SNF QRP. The commenter
specifically suggested measures of turnover as a percentage of nursing
staff, total CNA hours per patient day, and total licensed nursing
hours per patient day.
    Response: We thank the commenter for these suggestions and will
take them into account if Congress should expand the Program's
authority to allow us to adopt other measures.
    Comment: A commenter requested that CMS align the measure
specifications for the potentially preventable hospital readmissions
measures used in our value-based purchasing and quality reporting
programs.
    Response: As we noted in the FY 2020 SNF PPS proposed rule (84 FR
17680), the SNFPPR utilizes a 30-day post-hospital discharge
readmission window, while the SNF QRP's potentially preventable
readmission measure utilizes a 30-day post-SNF discharge readmission
window, which is consistent with the discharge readmission window
specified in other measures that we have developed with respect to
domains described in section 1899B of the Act. Those other measures
include the Potentially Preventable 30-Day Post-Discharge Readmission
Measure for Inpatient Rehabilitation Facility QRP and the Potentially
Preventable 30-Day Post-Discharge Readmission Measure for Home Health
QRP.
    As we explained in the proposed rule, with reference to the FY 2017
SNF PPS final rule (81 FR 51992), our rationale for having adopted two
different measures of potentially preventable hospital readmissions for
use in the SNF VBP Program and SNF QRP was that the readmission window
associated with each measure assesses different aspects of care. We
continue to believe that this distinction is useful, and we are
finalizing our policy to rename the SNFPPR to minimize confusion
between these measures.
(2) SNFPPR Update--Change of Measure Name
    In the FY 2017 SNF PPS final rule (81 FR 51987 to 51995), we
adopted the SNFPPR as the SNF all-condition risk-adjusted potentially
preventable hospital readmission measure for the SNF VBP Program to
meet the requirements in section 1888(g)(2) of the Act. This claims-
based measure assesses the facility-level risk-standardized rate of
unplanned, potentially preventable hospital readmissions for SNF
patients within 30 days of discharge from a prior admission to an
Inpatient Prospective Payment System (IPPS) hospital, CAH, or
psychiatric hospital. However, we have not yet transitioned the SNF VBP
Program to using the SNFPPR.
    The SNFPPR is one of two potentially preventable readmission
measures specified for use in the SNF setting. The SNFPPR is specified
for use for the SNF VBP Program and a second measure, the Potentially
Preventable 30-Day Post-Discharge Readmission Measure for Skilled
Nursing Facility Quality Reporting Program, is specified for use in the
SNF QRP. While these two measures are aligned in terms of exclusion
criteria and risk adjustment approach, they differ in their readmission
windows. The SNFPPR utilizes a 30-day post-hospital discharge
readmission window whereas the SNF QRP potentially preventable
readmission measure utilizes a 30-day post-SNF discharge readmission
window, consistent with the discharge readmission window specified in
other measures we have developed with respect to domains described in
section 1899B of the Act, such as the Potentially Preventable 30-Day
Post-Discharge Readmission Measure for Inpatient Rehabilitation
Facility QRP and the Potentially Preventable 30-Day Post-Discharge
Readmission Measure for Home Health QRP.
    As described in the FY 2017 SNF PPS final rule (81 FR 51992), our
rationale for having two different measures was that the readmission
window associated with each measure assesses different aspects of SNF
care. The readmission window for the SNFPPR measure was developed to
align with the SNFRM which was previously adopted for the SNF VBP
Program. Both the SNFRM and SNFPPR measure specifications, including
the readmission window, were designed to harmonize with CMS's Hospital
Wide All-Cause Unplanned Readmission (HWR) measure used in the Hospital
IQR Program. The advantage of this window is that it assesses
readmissions both during the SNF stay and post-SNF discharge for most
SNF patients, depending on the SNF length of stay (LOS).
    The readmission window used for the SNF QRP measure aligns with the
readmission window used in other readmission measures for post-acute
care (PAC) providers. The focus of this post-PAC only discharge
readmission window is on assessing potentially preventable hospital
readmissions during the 30 days after discharge from the PAC provider.
    While the SNFPPR and the SNF QRP potentially preventable
readmission measures assess different aspects of SNF care, we have
received stakeholder feedback that having two SNF potentially
preventable readmission measures has caused confusion. To minimize the
confusion surrounding these two different measures, we are changing the
name of the SNFPPR to Skilled Nursing Facility Potentially Preventable
Readmissions after Hospital Discharge. We believe this new measure name
will clearly differentiate the SNF VBP potentially preventable
readmission measure from the SNF QRP potentially preventable
readmission measure, thereby reducing stakeholder confusion. We intend
to submit the SNFPPR measure, hereafter referred to as the Skilled
Nursing Facility Potentially Preventable Readmissions after Hospital
Discharge measure, to the National Quality Forum (NQF) for endorsement
review as soon as that is feasible.
    We received several comments on the proposed measure renaming and
on the Program's plans to transition to the SNFPPR. The comments and
our responses are discussed below.
    Comment: Several commenters supported CMS' proposal to rename the
SNFPPR. A commenter noted too many similarly named measures can be
confusing. Another commenter stated that the new name will provide a
more accurate description of the measure. Other commenters requested
that CMS clarify what acronym they would prefer that stakeholders use
to refer to the renamed measure and requested that CMS announce its
plans to implement the measure as soon as possible.
    Response: As we did in the FY 2020 SNF PPS proposed rule (84 FR
17680), we intend to refer to the renamed measure as the SNFPPR
measure, and we intend to assess when to transition the Program to the
SNFPPR measure once we have submitted the measure to NQF for
endorsement review.
    Comment: A commenter applauded CMS' decision to submit the SNFPPR
for NQF endorsement and suggested that CMS delay the measure's
implementation until after endorsement has been received.
    Response: We thank the commenter for its support. As stated above,
we intend to assess when to transition the Program to the SNFPPR
measure once we have submitted the measure to NQF for endorsement
review.
    Comment: A commenter encouraged CMS to provide plans for the
SNFPPR's implementation in the SNF VBP Program as soon as possible. The
commenter suggested that monitoring performance across multiple program
years prior to transitioning to the SNFPPR will help SNFs track how
their assessments change and how their
[[Page 38822]]
quality planning affects their performance.
    Response: We intend to provide as much information as possible to
SNFs about their performance under the Program when we propose to
transition the measure.
    Comment: Commenter urged CMS to transition the SNF VBP Program to
the SNFPPR, stating that SNFs have incentives to treat low-acuity
patients and avoid high-acuity patients since the Program uses a
measure of all-cause hospital readmissions.
    Response: As we stated in the FY 2020 SNF PPS proposed rule (84 FR
17680), we intend to submit the measure for NQF endorsement review as
soon as that is feasible, and we intend to assess when to transition
the Program to the SNFPPR measure once we have submitted it for review.
Regarding the commenter's concern that the SNFRM could create an
incentive for SNFs to avoid high-acuity patients, as we stated in the
FY 2016 SNF PPS final rule (80 FR 46413), the SNFRM, which was endorsed
by the NQF, has been risk-adjusted for case-mix to account for
differences in patient populations. The goal of risk adjustment is to
account for these differences so that providers who treat sicker or
more vulnerable patient populations are not unnecessarily penalized for
factors that are outside of their control. However, we continually
evaluate and monitor the Program for unintended consequences.
    Comment: A commenter encouraged CMS to seek NQF endorsement of the
SNFPPR. Two commenters requested that CMS provide a timeline for the
measure's incorporation into the program as a replacement for the
SNFRM.
    Response: As we stated in the FY 2020 SNF PPS proposed rule (84 FR
17680), we intend to submit the measure for NQF endorsement review as
soon as that is feasible, and intend to assess when to transition the
Program to the SNFPPR measure once we have submitted it for review.
    After consideration of the comments that we received, we are
finalizing our proposal to rename the Skilled Nursing Facility
Potentially Preventable Readmissions after Hospital Discharge measure
as proposed.
c. FY 2022 Performance Period and Baseline Period
    We refer readers to the FY 2016 SNF PPS final rule (80 FR 46422)
for a discussion of our considerations for determining performance
periods under the SNF VBP Program. Based on those considerations, as
well as public comment, we adopted CY 2017 as the performance period
for the FY 2019 SNF VBP Program, with a corresponding baseline period
of CY 2015.
    Additionally, in the FY 2018 SNF PPS final rule (82 FR 36613
through 36614), we adopted FY 2018 as the performance period for the FY
2020 SNF VBP Program, with a corresponding baseline period of FY 2016.
We refer readers to that rule for a discussion of the need to shift the
Program's measurement periods from the calendar year to the fiscal
year. Finally, we refer readers to the FY 2019 SNF PPS final rule (83
FR 39277 through 39278), where we adopted FY 2019 as the performance
period for the FY 2021 program year, with a corresponding baseline
period of FY 2017. In that final rule, we also adopted a policy where
we would adopt for each program year a performance period that is the
1-year period following the performance period for the previous program
year. We adopted a similar policy for the baseline period, where we
stated that we would adopt for each program year a baseline period that
is the 1-year period following the baseline period for the previous
year.
    Under this policy, the performance period for the FY 2022 program
year will be FY 2020, and the baseline period will be FY 2018.
d. Performance Standards
(1) Background
    We refer readers to the FY 2017 SNF PPS final rule (81 FR 51995
through 51998) for a summary of the statutory provisions governing
performance standards under the SNF VBP Program and our finalized
performance standards policy, as well as the numerical values for the
achievement threshold and benchmark for the FY 2019 program year. We
also responded to public comments on these policies in that final rule.
    We published the final numerical values for the FY 2020 performance
standards in the FY 2018 SNF PPS final rule (82 FR 36613) and published
the final numerical values for the FY 2021 performance standards in the
FY 2019 SNF PPS final rule (83 FR 39276). We also adopted a policy
allowing us to correct the numerical values of the performance
standards in the FY 2019 SNF PPS final rule (83 FR 39276 through
39277).
(2) FY 2022 Performance Standards
    As we discussed in the proposed rule and in this final rule, we
will adopt FY 2018 as the baseline period for the FY 2022 program year
under our previously-adopted policy of advancing the performance and
baseline period for each program year automatically.
    Based on the baseline period for the FY 2022 program year, we
estimated in the proposed rule that the performance standards would
have the numerical values noted in Table 14. We stated that these
values represented estimates based on the most recently-available data,
and that we would update the numerical values in the FY 2020 SNF PPS
final rule. For reference, we are displaying those values again in
Table 14.
    Table 14--Estimated FY 2022 SNF VBP Program Performance Standards
------------------------------------------------------------------------
                                            Achievement
    Measure ID       Measure description     threshold       Benchmark
------------------------------------------------------------------------
SNFRM.............  SNF 30-Day All-Cause         0.79476         0.83212
                     Readmission Measure
                     (NQF #2510).
------------------------------------------------------------------------
    We received the following comment on the estimated performance
standards.
    Comment: A commenter supported CMS' finalized methodology for
performance standards calculation, but suggested that CMS consider
adopting an ``optimal'' or ``appropriate'' rate of readmission that
would not move with the national average. The commenter explained its
concern that the financial incentives to reduce readmissions rates
under the Program could create perverse incentives for providers to
keep patients in SNFs when they should more appropriately be sent back
to the hospital.
    Response: We would like to clarify that the SNF VBP Program's
achievement threshold is defined as the 25th percentile of SNFs'
performance during the baseline period, not the mean of SNFs'
performance during the baseline period. However, as we discussed in the
FY 2017 SNF PPS final rule (81 FR 51996), we adopted the Program's
performance standards definitions because we believe them to
[[Page 38823]]
represent achievable performance levels. We also note that our data
analysis has found no evidence that the Program's performance standards
will create perverse incentives for participating SNFs. We will
continue monitoring SNFs' performance on the SNFRM for any unintended
consequences of the Program as we assess when to transition the Program
to the SNFPPR.
    Table 15 contains the final numerical values for the FY 2022 SNF
VBP Program based on the FY 2018 baseline period.
     Table 15--Final FY 2022 SNF VBP Program Performance Standards *
------------------------------------------------------------------------
                            Measure         Achievement
      Measure ID          description        threshold       Benchmark
------------------------------------------------------------------------
SNFRM................  SNF 30-Day All-           0.79025         0.82917
                        Cause
                        Readmission
                        Measure (NQF
                        #2510).
------------------------------------------------------------------------
e. SNF VBP Performance Scoring
    We refer readers to the FY 2017 SNF PPS final rule (81 FR 52000
through 52005) for a detailed discussion of the scoring methodology
that we have finalized for the Program, along with responses to public
comments on our policies and examples of scoring calculations. We also
refer readers to the FY 2018 SNF PPS final rule (82 FR 36614 through
36616) for discussion of the rounding policy we adopted, our request
for comments on SNFs with zero readmissions, and our request for
comments on a potential extraordinary circumstances exception policy.
    We also refer readers to the FY 2019 SNF PPS final rule (83 FR
39278 through 39281), where we adopted (1) a scoring policy for SNFs
without sufficient baseline period data, (2) a scoring adjustment for
low-volume SNFs, and (3) an extraordinary circumstances exception
policy.
    We did not propose any updates to SNF VBP scoring policies in the
proposed rule.
f. SNF Value-Based Incentive Payments
    We refer readers to the FY 2018 SNF PPS final rule (82 FR 36616
through 36621) for discussion of the exchange function methodology that
we have adopted for the Program, as well as the specific form of the
exchange function (logistic, or S-shaped curve) that we finalized, and
the payback percentage of 60 percent. We adopted these policies for FY
2019 and subsequent fiscal years.
    We also discussed the process that we undertake for reducing SNFs'
adjusted Federal per diem rates under the Medicare SNF PPS and awarding
value-based incentive payments in the FY 2019 SNF PPS final rule (83 FR
39281 through 39282).
    For estimates of FY 2020 SNF VBP Program incentive payment
multipliers, we encourage SNFs to refer to FY 2019 SNF VBP Program
performance information, available at https://data.medicare.gov/Nursing-Home-Compare/SNF-VBP-Facility-Level-Dataset/284v-j9fz. Our
analysis of historical SNF VBP data shows that the Program's incentive
payment multipliers appear to be relatively consistent over time. As a
result, we believe that the FY 2019 payment results represent our best
estimate of FY 2020 performance at this time.
    We did not propose any updates to SNF VBP payment policies in the
proposed rule. However, for the reader's information, we modeled the
estimated impacts of the low-volume adjustment policy that we
established in the FY 2019 SNF PPS final rule for FY 2020 and estimated
that the application of the low-volume adjustment policy to the FY 2020
program year would redistribute an additional $8.1 million to these
low-volume SNFs for that program year. This would increase the 60
percent payback percentage for FY 2020 by approximately 1.51 percent,
resulting in a payback percentage for FY 2020 that is 61.51 percent of
the estimated $534.1 million in withheld funds for that fiscal year.
    We received several comments on SNF VBP incentive payments policy.
The comments and our responses are discussed below.
    Comment: Commenters expressed concern about the payback percentage
that we finalized for the SNF VBP Program, stating instead that the
full amount taken from SNFs' Medicare payments should be remitted to
SNFs, similar to how the withheld funds are redistributed in the
Hospital VBP Program.
    Response: As we have explained in prior rulemaking (see, for
example, the FY 2019 SNF PPS final rule, 82 FR 36620), section
1888(h)(5)(C)(ii)(III) of the Act provides that the total amount of
value-based incentive payments for all SNFs in a fiscal year must be
greater than or equal to 50 percent, but not greater than 70 percent of
the total amount of the reductions to SNFs' Medicare payments for that
fiscal year, as estimated by the Secretary. We do not have the
authority to set the payback percentage higher than 70 percent as the
commenter suggests.
    Comment: Commenters urged CMS to revisit the payback percentage
policy and remit 70 percent of the amount withheld from SNFs' Medicare
payments instead of the finalized 60 percent. Commenters also
recommended that CMS use the remaining 30 percent of funds for quality
improvement initiatives in SNFs.
    Response: We responded to numerous comments recommending that we
adopt a 70 percent payback percentage in the FY 2018 SNF PPS final rule
(82 FR 36620 through 36621) and we do not believe, at this time, that
it is appropriate to change the payback percentage since the SNF VBP
Program is only entering its second year of incentive payments. We
believe that additional time is necessary for CMS to assess the
Program's impacts on the quality of care provided to Medicare
beneficiaries. We will continue monitoring the SNF VBP Program's
effects on SNFs' Medicare payments and quality improvement practices
and will consider revisiting our finalized payback percentage policy in
the future. Additionally, we note that the funds that are not paid back
to SNFs as incentive payments represent savings to the Medicare
program, and those funds cannot be allocated separately for quality
improvement initiatives in SNFs.
g. Public Reporting on the Nursing Home Compare Website
(1) Background
    Section 1888(g)(6) of the Act requires the Secretary to establish
procedures to make SNFs' performance information on SNF VBP Program
measures available to the public on the Nursing Home Compare website or
a successor, and to provide SNFs an opportunity to review and submit
corrections to that information prior to its publication. We began
publishing SNFs' performance information on the SNFRM in accordance
with this directive and the statutory deadline of October 1, 2017.
[[Page 38824]]
    Additionally, section 1888(h)(9)(A) of the Act requires the
Secretary to make available to the public certain information on SNFs'
performance under the SNF VBP Program, including SNF Performance Scores
and their ranking. Section 1888(h)(9)(B) of the Act requires the
Secretary to post aggregate information on the Program, including the
range of SNF Performance Scores and the number of SNFs receiving value-
based incentive payments, and the range and total amount of those
payments.
    In the FY 2017 SNF PPS final rule (81 FR 52009), we discussed the
statutory requirements governing public reporting of SNFs' performance
information under the SNF VBP Program. We also sought and responded to
public comments on issues that we should consider when posting
performance information on Nursing Home Compare or a successor website.
In the FY 2018 SNF PPS final rule (82 FR 36622 through 36623), we
finalized our policy to publish SNF measure performance information
under the SNF VBP Program on Nursing Home Compare after SNFs have had
an opportunity to review and submit corrections to that information
under the two-phase Review and Corrections process that we adopted in
the FY 2017 SNF PPS final rule (81 FR 52007 through 52009) and for
which we adopted additional requirements in the FY 2018 SNF PPS final
rule. In the FY 2018 SNF PPS final rule, we also adopted requirements
to rank SNFs and adopted data elements that we will include in the
ranking to provide consumers and stakeholders with the necessary
information to evaluate SNFs' performance under the Program.
(2) Public Reporting of SNF Performance Scores, Achievement and
Improvement Scores, and Ranking
    As we have considered issues associated with public reporting of
SNFs' performance information on the Nursing Home Compare website, we
have identified an issue that we believe warrants additional
discussion. We are concerned that the performance information available
for display for a specific SNF may, as a result of the application of
two policies we have finalized for the Program, be confusing to the
public. Specifically, SNFs with fewer than 25 eligible stays during the
baseline period for a fiscal year will only be scored on achievement
and will not have improvement information available for display. In
addition, a SNF with fewer than 25 eligible stays during a performance
period will receive an assigned SNF performance score for that Program
year that results in a value-based incentive payment amount equal to
the adjusted federal per diem rate that the SNF would have received for
the fiscal year in the absence of the Program.
    In these cases, we stated that we did not believe it would be
appropriate to suppress the SNF's information entirely given the
statutory requirements in section 1888(h)(9)(A) of the Act to publicly
report SNF-specific information, but we stated our concerns about
publishing performance information that is not based on enough data to
convey a complete and reliable picture of a SNF's performance for the
Program year.
    Based on these considerations, we proposed to suppress the SNF
information available to display as follows: (1) If a SNF has fewer
than 25 eligible stays during the baseline period for a Program year,
we would not display the baseline RSRR or improvement score, though we
would still display the performance period RSRR, achievement score and
total performance score if the SNF had sufficient data during the
performance period; (2) if a SNF has fewer than 25 eligible stays
during the performance period for a Program year and receives an
assigned SNF performance score as a result, we would report the
assigned SNF performance score and we would not display the performance
period RSRR, the achievement score or improvement score; and (3) if a
SNF has zero eligible cases during the performance period for a Program
year, we would not display any information for that SNF. Based on
historical data, we estimated that approximately 16 percent of SNFs
will have fewer than 25 eligible stays during the performance period
and similarly, approximately 16 percent of SNFs will have fewer than 25
stays in the baseline period for FY 2020.
    We stated our belief that this policy will ensure that we publish
as much information as possible about the SNF VBP Program's performance
assessments while ensuring that the published information is reliable
and based on a sufficient quantity of information. We further stated
that we believed that this policy will provide stakeholders with
meaningful information about SNFs' performance under the Program.
    We welcomed public comment on this proposal.
    Comment: Several commenters supported CMS' proposed public
reporting policies. Some commenters suggested that CMS explain on the
Nursing Home Compare website why scores are suppressed so that
consumers can accurately interpret the data presented.
    Response: We agree with the commenters. We intend to provide as
much information as possible so that the Nursing Home Compare website's
users clearly understand the performance information presented about
the Program.
    After consideration of the public comments that we have received,
we are finalizing our changes to the public reporting of SNF
Performance Scores, Achievement and Improvement Scores, and Ranking as
proposed.
h. Update to Phase One Review and Correction Deadline
    In the FY 2017 SNF PPS final rule (81 FR 52007 through 52009), we
adopted a two-phase review and corrections process for SNFs' quality
measure data that will be made public under section 1888(g)(6) of the
Act and SNF performance information that will be made public under
section 1888(h)(9) of the Act. We explained that we would accept
corrections to the quality measure data used to calculate the measure
rates that are included in any SNF's quarterly confidential feedback
report, and that we would provide SNFs with an annual confidential
feedback report containing the performance information that will be
made public. We detailed the process for requesting Phase One
corrections and finalized a policy whereby we would accept Phase One
corrections to any quarterly report provided during a calendar year
until the following March 31.
    However, as we have continued implementation of the SNF VBP
Program, we have reconsidered what deadline would be appropriate for
the Phase One correction process. Our experience managing the FY 2019
SNF VBP Program has shown that fewer than 10 facilities submitted
sufficient correction information under the Phase One correction
process after October 1, 2018 and before March 31, 2019. Additionally,
we stated our concerns about the effects of the March 31 deadline on
value-based incentive payment calculations since the deadline is
currently 6 months after payment incentives begin. For example,
performance score reports for the FY 2019 SNF VBP Program were provided
in August 2018 and incentive payments for that FY were made beginning
with services provided on October 1, 2018, but SNFs still had until
March 31, 2019 to make a correction. We stated our belief that the
March 31 deadline also creates uncertainty for SNFs because, as shown
above in the timeline that applied to the FY 2019 Program, their
[[Page 38825]]
payment incentives could potentially change 6 months after they take
effect. If we were to approve a correction request, we would then need
to reprocess several months of claims for the SNF in question and
potentially need to adjust the exchange function for the fiscal year
depending on the scope of the correction and its effects on the payback
percentage pool for the fiscal year. We stated that we did not believe
these outcomes are beneficial to the Program or to SNFs that would have
less predictability about their incentive payment percentages for the
fiscal year. We stated our belief that the lack of predictability for
SNF payment percentages might adversely impact SNF financial planning
because payment amounts would not be set for all SNFs until after the
March 31 deadline.
    We stated our belief that we could mitigate this uncertainty by
adopting a 30-day deadline for Phase One correction requests, and noted
that this proposal would align the Phase One review and correction
process with the Phase Two process. Under current Program operations,
we issue a report in June that contains all of the underlying claim
information used to calculate the measure rate for the program year, as
well as the measure rate itself. We proposed that SNFs would have 30
days from the date that we issue that report to review the claims and
measure rate information and to submit to us a correction request if
the SNF believes that any of that information is inaccurate. We noted
that this proposal would not preclude a SNF from submitting a
correction request for any claims for which it discovers an error prior
to receiving the June report. However, the 30 day review and correction
period would commence on the day that we issue the June report, and a
SNF would not be able to request that we correct any underlying claims
or its measure rate after the conclusion of that 30 day period.
    We proposed this 30-day deadline in lieu of the current March 31
deadline for Phase One corrections. We noted that we initially proposed
to adopt a 30-day deadline for Phase One corrections in the FY 2017 SNF
PPS proposed rule (81 FR 24255), though we finalized a deadline of
March 31 following the calendar year in which we provide the report. We
adopted that extended deadline to balance our desire to ensure that
measure data are sufficiently accurate with SNFs' need for sufficient
information with which to evaluate those reports, as well as to provide
SNFs with more time to review each quarter's data. In addition, we
encouraged SNFs to review the quarterly reports provided with stay-
level information and make any corrections to claims before the
proposed deadline. However, for the reasons discussed above, we stated
that we now believe that a 30-day timeframe is sufficient for SNFs to
determine if there were errors in the measure calculation by CMS or its
contractor.
    We stated our belief that this policy will ensure that the
underlying claims data that we use to calculate quality measure
performance for the SNF VBP Program will be finalized prior to their
use in scoring and payment calculations. We also stated our belief that
this policy will also ensure that any corrections submitted under Phase
One do not result in changes to quality measure data months after
incentive payment calculations, which will also avoid changes to the
exchange function, and as a result, changes to other SNFs' value-based
incentive payment percentages for a fiscal year because of data errors
for any SNFs. Our experience managing the 2019 SNF VBP Program
indicated that very few SNFs would be adversely impacted by the earlier
deadline. We also sought to provide SNFs with earlier final annual
payment percentage information for their financial planning purposes.
    We welcomed public comments on this proposal.
    Comment: A commenter agreed that the current Phase One Review and
Corrections deadline may not be ideal, but expressed concern about the
proposed 30-day deadline. The commenter suggested that 30 days may not
provide enough time for SNFs to complete Phase One corrections,
especially if they must collaborate with hospitals, and recommended
that CMS adopt a 60-day deadline instead. Another commenter suggested a
90-day deadline, stating that smaller SNFs often do not have the
manpower available to review feedback reports promptly.
    Response: As we stated in the proposed rule, our proposal would not
forestall SNFs from submitting correction requests prior to their
receipt of the June report if they believe that an error has occurred,
after reviewing data from quarterly reports delivered prior to the June
report. Our intention with this proposal is, as we stated, to ensure
that any corrections submitted under Phase One do not result in changes
to quality measure data months after the incentive payment calculations
are completed, which would necessitate changes to the exchange
function, and as a result, changes to other SNFs' value-based incentive
payment percentages for a fiscal year. Additionally, we note that we
previously received public comments supportive of a 30-day deadline for
Review and Corrections to which we provided responses in the FY 2017
SNF PPS final rule (81 FR 52008). We believe that SNFs have, by now,
accumulated extensive experience with the SNF VBP Program's report
system, as well as the finalized Review and Corrections processes.
Further, the 30-day review and correction deadline would align the SNF
VBP Program with other similar CMS programs.
    We will continue to conduct outreach and education to ensure that
SNFs are fully aware of the Program's operational deadlines, and we
will strive to be as clear as possible about the timeline for
corrections once we provide each report to SNFs.
    After consideration of the public comments that we have received,
we are finalizing our proposed update to the Phase One Review and
Corrections deadline as proposed.
IV. Collection of Information Requirements
    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et
seq.), we are required to publish a 30-day notice in the Federal
Register and solicit public comment before a ``collection of
information'' requirement is submitted to the Office of Management and
Budget (OMB) for review and approval. For the purposes of the PRA and
this section of the preamble, collection of information is defined
under 5 CFR 1320.3(c) of the PRA's implementing regulations.
    To fairly evaluate whether an information collection should be
approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit
comment on the following issues:
     The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be
collected.
     Our effort to minimize the information collection burden
on the affected public, including the use of automated collection
techniques.
    In our April 25, 2019 proposed rule (84 FR 17620), we solicited
public comment on each of the section 3506(c)(2)(A)-required issues for
the following information collection requirements. As indicated in
section IV.B.1. of this final rule, we received public comments and
provide a summary of the comments and our responses in that section.
Based on internal review, we have revised the number of items we are
adding across the PPS 5-day and PPS discharge
[[Page 38826]]
assessments to 59.5 items, as compared to the proposed 60.5 items in
the FY 2020 SNF PPS proposed rule.
A. Wage Estimates
    To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' (BLS) May 2018 National Occupational Employment and Wage
Estimates for all salary estimates (as compared to the FY 2020 SNF PPS
proposed rule which used BLS' May 2017 estimates of $41.18/hr for a
health information technician and $70.72/hr for a registered nurse)
(http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 16
presents the mean hourly wage, the cost of fringe benefits and overhead
(calculated at 100 percent of the mean hourly wage), and the adjusted
hourly wage. The adjusted wage is used to derive this section's average
cost estimates.
                          Table 16--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    benefits and      Adjusted
                Occupation title                       code         wage ($/hr)    overhead ($/   hourly wage ($/
                                                                                        hr)             hr)
----------------------------------------------------------------------------------------------------------------
Health Information Technician...................         29-2071           21.16           21.16           42.32
Registered Nurse................................         29-1141           36.30           36.30           72.60
----------------------------------------------------------------------------------------------------------------
    As indicated, we are adjusting our employee hourly wage estimates
by a factor of 100 percent. This is necessarily a rough adjustment,
both because fringe benefits and overhead costs vary significantly from
employer to employer, and because methods of estimating these costs
vary widely from study to study. Nonetheless, we believe that doubling
the mean hourly wage to help estimate the total cost is a reasonably
accurate estimation method.
B. Information Collection Requirements (ICRs)
1. ICRs Regarding the SNF Quality Reporting Program (QRP)
    The following changes will be submitted to OMB for approval under
control number 0938-1140 (CMS-10387). While the changes do not impose
any new or revised burden, they revise our SNF QRP requirements by
adding 59.5 items across the PPS 5-day and PPS discharge assessments.
Costs have been adjusted to account for more recent wage data. An
analysis of the impact for adding the 59.5 items can be found in
section V. of this final rule. Subject to renewal, the control number
is currently set to expire on February 28, 2022. It was last approved
on February 12, 2019, and remains active.
    The Minimum Data Set (MDS) is part of the process for the clinical
assessment of all SNF residents and serves multiple purposes. It is
used as a data collection tool for SNFs in the PPS to inform the PDPM
for the purpose of reimbursement and for the SNF QRP for the purpose of
monitoring the quality of care in SNFs.
    The MDS assessments that are used to inform payment consist of the
PPS 5-day assessment, the PPS discharge assessment, and the optional
Interim Payment Assessment (IPA). The requirements necessary to
administer the payment rate methodology described in 42 CFR 413.337 are
subject to the PRA. Thus, the PPS 5-day, PPS discharge, and IPA
assessments are subject to the PRA and are active under the
aforementioned control number. For the readers' convenience, the active
burden estimates are summarized in Table 17. It is important to note
that SNFs currently collect and report data for the SNF QRP through the
PPS 5-day and PPS discharge assessments, which are the same assessments
used in the PDPM. The IPA is an optional assessment for the PDPM and is
not used for the SNF QRP.
    Section 2(a) of the IMPACT Act established section 1899B of the
Act, which requires, among other things, SNFs to report standardized
patient assessment data, data on quality measures, and data on resource
use and other measures. Under section 1899B(m) of the Act,
modifications to the MDS required to achieve standardization of patient
assessment data are exempt from PRA requirements. Standardization has
been met upon our adoption of the proposed data elements and
standardized patient assessment data in this final rule. For FY 2020
and thereafter, the exemption of the SNF QRP from the PRA is no longer
applicable such that the SNF QRP requirements and burden will be
submitted to OMB for review and approval. The active ICR serves as the
basis for which we now address the previously exempt requirements and
burden.
    Under our active information collection, only the PPS 5-day and PPS
discharge assessments used in the PDPM are also used as the assessments
for collecting quality measure and standardized patient assessment data
under the SNF QRP. Our active burden sets out 51 minutes (0.85 hours)
per PPS 5-day assessment and 51 minutes per PPS discharge assessment.
Consistent with the FY 2019 SNF PPS final rule (83 FR 39283) we
continue to use the OMRA assessment (with 272 items) to estimate the
amount of time to complete a PPS assessment. This is also consistent
with our active information collection. In sections III.E.1.d. and
III.E.1.g. of this rule, we are adding 59.5 items across the PPS 5-day
and PPS discharge assessments. Given that the PPS OMRA item set has 272
items (as compared to the PPS discharge assessment with 143 items) that
are approved under our active collection, the added items, while
increasing burden for each of the assessments, have no impact on our
currently approved burden estimates since the active collection uses
the PPS OMRA item set as a proxy for all assessments. Below, however,
we are restating such burden, with updated cost estimates based on more
recent BLS wage figures, as a courtesy to interested parties.
    When calculating the burden for each assessment, we estimate it
will take 40 minutes (0.6667 hours) at $72.60/hr for an RN to collect
the information necessary for preparing the assessment, 10 minutes
(0.1667 hours) at $57.46/hr (the average hourly wage for RN ($72.60/hr)
and health information technician ($42.32/hr)) for staff to code the
responses, and 1 minute (0.0167 hours) at $42.32/hr for a health
information technician to transmit the results. In total, we estimate
that it will take 51 minutes (0.85 hours) to complete a single PPS
assessment. Based on the adjusted hourly wages for the noted staff, we
estimate that it will cost $58.69 [($72.60/hr x 0.6667 hr) + ($57.46/hr
x 0.1667 hr) + ($42.32/hr x 0.0167 hr)] to prepare, code, and transmit
each PPS assessment.
    Based on our most current data, there are 15,471 Medicare Part A
SNFs. Based on FY 2017 data, we estimate that 2,406,401 5-day PPS
assessments will be completed and submitted by Part A SNFs each year
under the PDPM and SNF QRP. We used the same number of
[[Page 38827]]
assessments (2,406,401) as a proxy for the number of PPS discharge
assessments that would be completed and submitted each year, since all
residents who require a 5-day PPS assessment will also require a
discharge assessment under the PDPM and SNF QRP. We use the Significant
Change in Status Assessment (SCSA) as a proxy to estimate the number of
IPAs as the criteria for completing an SCSA is similar to that for the
IPA. Based on FY 2017 data, 92,240 IPAs would be completed per year
under the PDPM.
    The total number of PPS 5-day assessments, PPS discharge
assessments, and IPAs that will be completed across all facilities is
4,905,042 assessments (2,406,401 + 2,406,401 + 92,240, respectively).
In aggregate, we estimate an annual burden for all assessments across
all facilities of 4,169,286 hours (4,905,042 assessments x 0.85 hours/
assessment) at a cost of $287,876,914 (4,905,042 assessments x $58.69/
assessment).
    Given that adding 59.5 items across the PPS 5-day and PPS discharge
assessments is accounted for by using the OMRA assessment as a proxy
for all assessments, and given that our estimate for the number of
Medicare Part A SNFs and for the number PPS 5-day and PPS discharge
assessments completed and submitted by Part A SNFs each year remains
unchanged, we are not revising or adjusting any of our active burden
estimates, except for adjusting our cost estimates as indicated above.
In this regard, we will be submitting a revised information collection
request to OMB to account for the added items and adjusted costs.
    Further, in section III.E.1.h.(2) of this final rule, there are no
burden implications associated with updating the data submission system
to the iQIES for the SNF QRP once it becomes available. This
designation is a replacement of the existing QIES ASAP data submission
system and imposes no additional requirements or burden on the part of
SNFs.
    We received the following comments on our collections of
information estimates.
    Comment: One commenter stated that adding items across the PPS 5-
day and discharge assessments would result in increased burden,
especially due to the time required to complete resident interview
items.
    Response: We acknowledge that adding items for the SNF QRP across
the PPS 5-day and discharge assessments increases burden for providers.
However, we continue to believe that these items are accounted for in
our active burden estimates, given that we use the PPS OMRA as the
proxy for all assessments. The PPS OMRA item set has 272 items (as
compared to the PPS discharge assessment with 143 items) that are
approved under our active collection. The 59.5 added items are
accounted for since the PPS OMRA is used as a proxy for the shorter PPS
discharge assessment. Therefore, we intend to move forward with the
addition of these 59.5 items.
    Comment: Another commenter requested that CMS consider staging
additional SNF QRP requirements in a way that would allow SNFs more
time to adapt the to the PDPM payment methodology.
    Response: We note that the PDPM takes effect in the October 1,
2019, while SNFs are not required to begin data collection for the SNF
QRP requirements finalized in this final rule until October 1, 2020,
thereby by allowing a year to adjust to the PDPM before the finalized
SNF QRP requirements take effect. Therefore, we intend to move forward
with the addition of these 59.5 items.
2. ICRs Regarding the SNF VBP Program
    We are not removing, adding, or revising any of our SNF VBP
measure-related requirements or burden. Consequently, the rule contains
no SNF-VBP related collections of information that are subject to OMB
approval under the authority of the PRA.
C. Summary of Requirements and Annual Burden Estimates
                      Table 17--Summary of Requirements and Annual Burden Estimates Under OMB Control Number 0938-1140 (CMS-10387)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Responses
         Program changes             Number of         (per            Total         Time per       Total time    Labor cost per hour ($/ Total cost ($)
                                    respondents     respondent)      responses     response (hr)       (hr)                 hr)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active Burden...................          15,471          317.04       4,905,042            0.85       4,169,286  varies................     280,421,251
Changes under CMS-1718-F........               0               0               0               0               0  varies................      +7,455,663
                                 -----------------------------------------------------------------------------------------------------------------------
    Total.......................          15,471          317.04       4,905,042            0.85       4,169,286  varies................     287,876,914
--------------------------------------------------------------------------------------------------------------------------------------------------------
V. Economic Analyses
A. Regulatory Impact Analysis
1. Statement of Need
    This final rule updates the FY 2020 SNF prospective payment rates
as required under section 1888(e)(4)(E) of the Act. It also responds to
section 1888(e)(4)(H) of the Act, which requires the Secretary to
provide for publication in the Federal Register before the August 1
that precedes the start of each FY, the unadjusted federal per diem
rates, the case-mix classification system, and the factors to be
applied in making the area wage adjustment. As these statutory
provisions prescribe a detailed methodology for calculating and
disseminating payment rates under the SNF PPS, we do not have the
discretion to adopt an alternative approach on these issues.
2. Introduction
    We have examined the impacts of this final rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA,
September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA, March
22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August
4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs
(January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563
[[Page 38828]]
emphasizes the importance of quantifying both costs and benefits, of
reducing costs, of harmonizing rules, and of promoting flexibility.
This rule has been designated an economically significant rule, under
section 3(f)(1) of Executive Order 12866. Accordingly, we have prepared
a regulatory impact analysis (RIA) as further discussed below. Also,
the rule has been reviewed by OMB.
3. Overall Impacts
    This final rule sets forth updates of the SNF PPS rates contained
in the SNF PPS final rule for FY 2019 (83 FR 39162). We estimate that
the aggregate impact will be an increase of approximately $851 million
in payments to SNFs in FY 2020, resulting from the SNF market basket
update to the payment rates. We note that these impact numbers do not
incorporate the SNF VBP reductions that we estimate will total $527.4
million in FY 2020. We would note that events may occur to limit the
scope or accuracy of our impact analysis, as this analysis is future-
oriented, and thus, very susceptible to forecasting errors due to
events that may occur within the assessed impact time period.
    In accordance with sections 1888(e)(4)(E) and (e)(5) of the Act, we
update the FY 2019 payment rates by a factor equal to the market basket
index percentage change adjusted by the MFP adjustment to determine the
payment rates for FY 2020. The impact to Medicare is included in the
total column of Table 18. In updating the SNF PPS rates for FY 2020, we
made a number of standard annual revisions and clarifications mentioned
elsewhere in this final rule (for example, the update to the wage and
market basket indexes used for adjusting the federal rates).
    The annual update set forth in this final rule applies to SNF PPS
payments in FY 2020. Accordingly, the analysis of the impact of the
annual update that follows only describes the impact of this single
year. Furthermore, in accordance with the requirements of the Act, we
will publish a rule or notice for each subsequent FY that will provide
for an update to the payment rates and include an associated impact
analysis.
4. Detailed Economic Analysis
    The FY 2020 SNF PPS payment impacts appear in Table 18. Using the
most recently available data, in this case FY 2018, we apply the
current FY 2019 wage index and labor-related share value to the number
of payment days to simulate FY 2019 payments. Then, using the same FY
2018 data, we apply the FY 2020 wage index and labor-related share
value to simulate FY 2020 payments. We tabulate the resulting payments
according to the classifications in Table 18 (for example, facility
type, geographic region, facility ownership), and compare the simulated
FY 2019 payments to the simulated FY 2020 payments to determine the
overall impact. The breakdown of the various categories of data Table
18 follows:
     The first column shows the breakdown of all SNFs by urban
or rural status, hospital-based or freestanding status, census region,
and ownership.
     The first row of figures describes the estimated effects
of the various changes on all facilities. The next six rows show the
effects on facilities split by hospital-based, freestanding, urban, and
rural categories. The next nineteen rows show the effects on facilities
by urban versus rural status by census region. The last three rows show
the effects on facilities by ownership (that is, government, profit,
and non-profit status).
     The second column shows the number of facilities in the
impact database.
     The third column shows the effect of the transition to
PDPM. This represents the effect on providers, assuming no changes in
behavior or case-mix, from changing the case-mix classification model
used to classify patients in a Medicare Part A SNF stay. The total
impact of this change is 0.0 percent; however, there are distributional
effects of this change.
     The fourth column shows the effect of the annual update to
the wage index. This represents the effect of using the most recent
wage data available. The total impact of this change is 0.0 percent;
however, there are distributional effects of the change.
     The fifth column shows the effect of all of the changes on
the FY 2020 payments. The update of 2.4 percent is constant for all
providers and, though not shown individually, is included in the total
column. It is projected that aggregate payments will increase by 2.4
percent, assuming facilities do not change their care delivery and
billing practices in response.
    As illustrated in Table 18, the combined effects of all of the
changes vary by specific types of providers and by location. For
example, due to changes in this final rule, providers in the urban
Pacific region will experience a 1.6 percent increase in FY 2020 total
payments.
                                   Table 18--Impact to the SNF PPS for FY 2020
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                                   facilities FY    PDPM impact     Update wage    Total change
                                                       2020          (percent)    data (percent)     (percent)
----------------------------------------------------------------------------------------------------------------
Group:
    Total.......................................          15,078             0.0             0.0             2.4
    Urban.......................................          10,951            -0.7             0.0             1.7
    Rural.......................................           4,127             3.7             0.2             6.2
    Hospital-based urban........................             380             9.9             0.1            12.4
    Freestanding urban..........................          10,571            -1.0             0.0             1.4
    Hospital-based rural........................             245            20.4             0.3            23.1
    Freestanding rural..........................           3,882             3.1             0.2             5.6
Urban by region:
    New England.................................             775             2.0            -0.4             4.0
    Middle Atlantic.............................           1,470            -3.1            -0.1            -0.8
    South Atlantic..............................           1,868            -0.7            -0.2             1.5
    East North Central..........................           2,118             0.1             0.0             2.4
    East South Central..........................             536             0.7            -0.2             2.9
    West North Central..........................             921             3.8             0.6             6.8
    West South Central..........................           1,323            -1.3             0.2             1.3
    Mountain....................................             527             0.1             0.2             2.7
    Pacific.....................................           1,407            -0.9             0.1             1.6
    Outlying....................................               6            58.5            -0.4            60.5
[[Page 38829]]

Rural by region:
    New England.................................             126             5.4            -1.5             6.3
    Middle Atlantic.............................             194             2.3             0.0             4.8
    South Atlantic..............................             462             4.2             0.4             7.0
    East North Central..........................             908             3.4            -0.1             5.7
    East South Central..........................             452             2.4             0.3             5.1
    West North Central..........................           1,020            10.2             0.4            13.1
    West South Central..........................             666            -0.5             0.3             2.2
    Mountain....................................             207             6.0             1.2             9.6
    Pacific.....................................              92             1.4             0.3             4.1
Ownership:
    For profit..................................          10,729            -0.6             0.0             1.8
    Non-profit..................................           3,469             1.5             0.0             3.9
    Government..................................             880             4.5             0.1             7.0
----------------------------------------------------------------------------------------------------------------
Note: The Total column includes the 2.4 percent market basket increase factor. Additionally, we found no SNFs in
  rural outlying areas.
5. Impacts for the Skilled Nursing Facility (SNF) Quality Reporting
Program (QRP)
    As discussed in this final rule, we are adopting two new quality
measures beginning with the FY 2022 SNF QRP (see section III.E.1.d. of
this final rule). For these two quality measures, we are adding 4 data
elements on discharge which would require an additional 1.2 minutes of
nursing staff time per discharge. We estimate these data elements for
these quality measures would be completed by Registered Nurses (25
percent of the time or 0.30 minutes) at $72.60/hr and by Licensed
Practical Nurses (75 percent of the time or 0.90 minutes) at $45.24/hr.
With 2,406,401 discharges from 15,471 SNFs annually (see section IV.B.
of this final rule), we estimate an annual burden of 48,128 additional
hours (2,406,401 discharges x 1.2 min/60) at a cost of $2,506,507
(2,406,401 x [(0.30/60 x $72.60/hr) + (0.90/60 x $45.24/hr)]). For each
SNF we estimate an annual burden of 3.11 hours (48,128 hr/15,471 SNFs)
at a cost of $162.01 ($2,506,507/15,471 SNFs).
    We are finalizing requirements to collect 55.5 standardized patient
assessment data elements consisting of 8 data elements on admission and
47.5 data elements on discharge beginning with the FY 2022 SNF QRP. We
estimate that the data elements would take an additional 12.675 minutes
of nursing staff time consisting of 1.725 minutes to report on each
admission and 10.95 minutes to report on each discharge. We assume the
added data elements would be performed by both Registered Nurses (25
percent of the time or 3.169 minutes) and Licensed Practical Nurses (75
percent of the time or 9.506 minutes). We estimate the reporting of
these assessment items will impose an annual burden of 508,352 total
hours (2,406,401 discharges x 12.675 min/60) at a cost of $26,474,983
((508,352 hr x 0.25 x $72.60/hr) + (508,352 hr x 0.75 x $45.24/hr)).
For each SNF the annual burden is 32.86 hours (508,352 hr/15,471 SNFs)
at a cost of $1,711.27 ($26,474,983/15,471 SNFs).
    The overall annual cost of the finalized changes associated with
the newly added 59.5 assessment items is estimated at $1,873.28 per SNF
annually ($162.01 + $1,711.27), or $28,981,490 ($2,506,507 +
$26,474,983) for all 15,471 SNFs annually.
6. Impacts for the SNF VBP Program
    The impacts of the FY 2020 SNF VBP Program are based on historical
data and appear in Table 19. We modeled SNF performance in the Program
using SNFRM data from CY 2015 as the baseline period and CY 2017 as the
performance period. Additionally, we modeled a logistic exchange
function with a payback percentage of 60 percent, as we finalized in
the FY 2018 SNF PPS final rule (82 FR 36619 through 36621), though we
note that the 60 percent payback percentage for FY 2020 will adjust to
account for the low-volume scoring adjustment that we adopted in the FY
2019 SNF PPS final rule (83 FR 39278 through 39280). Based on the 60
percent payback percentage (as modified by the low-income scoring
adjustment), we estimate that we will redistribute approximately $320.4
million in value-based incentive payments to SNFs in FY 2020, which
means that the SNF VBP Program is estimated to result in approximately
$213.6 million in savings to the Medicare Program in FY 2020. We refer
readers to the FY 2019 SNF PPS final rule (83 FR 39278 through 39280)
for additional information about payment adjustments for low-volume
SNFs in the SNF VBP Program.
    Our detailed analysis of the impacts of the FY 2020 SNF VBP Program
follows in Table 19.
                                  Table 19--SNF VBP Program Impacts for FY 2020
----------------------------------------------------------------------------------------------------------------
                                                    Mean risk-
                                                   standardized        Mean                         Percent of
         Characteristic              Number of      readmission     performance   Mean incentive       total
                                    facilities     rate (SNFRM)        score        multiplier       incentive
                                                        (%)                                           payment
----------------------------------------------------------------------------------------------------------------
Group:
    Total.......................          15,421           19.42         37.2169         0.99309          100.00
    Urban.......................          11,007           19.47         36.1519         0.99262           85.16
    Rural.......................           4,414           19.31         39.8729         0.99426           14.84
    Hospital-based urban........             355           19.08         42.6453         0.99546            2.14
    Freestanding urban..........          10,602           19.48         35.9056         0.99251           82.98
[[Page 38830]]

    Hospital-based rural........             246           18.98         46.9882         0.99756            0.57
    Freestanding rural..........           3,943           19.32         39.3322           0.994           14.11
Urban by region:
    New England.................             786           19.54         33.0786         0.99119            5.75
    Middle Atlantic.............           1,473           19.25         38.8823         0.99365           15.92
    South Atlantic..............           1,869           19.56         35.6803         0.99256           17.39
    East North Central..........           2,122           19.52         34.5595         0.99174           14.08
    East South Central..........             551           19.69         32.2849         0.99095            3.68
    West North Central..........             923           19.46         36.7211         0.99281            4.01
    West South Central..........           1,336           19.84         31.4446         0.99065            7.32
    Mountain....................             530           18.92         44.5446         0.99634            3.63
    Pacific.....................           1,411           19.20         40.4522         0.99475           13.36
    Outlying....................               6           19.38         41.5899         0.99252            0.00
Rural by region:
    New England.................             134           19.12         39.8964         0.99396            0.67
    Middle Atlantic.............             214           19.14         40.4625         0.99406            0.86
    South Atlantic..............             493           19.42         36.8815         0.99294            2.22
    East North Central..........             931           19.15         40.6763         0.99452            3.43
    East South Central..........             520           19.60         34.5229         0.99178            2.31
    West North Central..........           1,064           19.14         44.0171         0.99615            1.93
    West South Central..........             738           19.85         33.6008         0.99171            2.16
    Mountain....................             222           18.78         49.4262         0.99862            0.65
    Pacific.....................              97           18.30         55.1379         1.00141            0.62
    Outlying:...................               1           18.98         37.0195         0.98788            0.00
Ownership:
    Government..................             982           19.11         43.3338         0.99568            3.70
    Profit......................          10,810           19.52         35.3904         0.99229           75.38
    Non-Profit..................           3,629           19.20         41.0027         0.99478           20.92
----------------------------------------------------------------------------------------------------------------
7. Alternatives Considered
    As described in this section, we estimated that the aggregate
impact for FY 2020 under the SNF PPS will be an increase of
approximately $851 million in payments to SNFs, resulting from the SNF
market basket update to the payment rates.
    Section 1888(e) of the Act establishes the SNF PPS for the payment
of Medicare SNF services for cost reporting periods beginning on or
after July 1, 1998. This section of the statute prescribes a detailed
formula for calculating base payment rates under the SNF PPS, and does
not provide for the use of any alternative methodology. It specifies
that the base year cost data to be used for computing the SNF PPS
payment rates must be from FY 1995 (October 1, 1994, through September
30, 1995). In accordance with the statute, we also incorporated a
number of elements into the SNF PPS (for example, case-mix
classification methodology, a market basket index, a wage index, and
the urban and rural distinction used in the development or adjustment
of the federal rates). Further, section 1888(e)(4)(H) of the Act
specifically requires us to disseminate the payment rates for each new
FY through the Federal Register, and to do so before the August 1 that
precedes the start of the new FY; accordingly, we are not pursuing
alternatives for this process.
8. Accounting Statement
    As required by OMB Circular A-4 (available online at https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/), in Tables 20
through 22, we have prepared an accounting statement showing the
classification of the expenditures associated with the provisions of
this final rule for FY 2020. Tables 18 and 20 provide our best estimate
of the possible changes in Medicare payments under the SNF PPS as a
result of the policies in this final rule, based on the data for 15,078
SNFs in our database. Table 21 provides our best estimate of the costs
for SNFs to submit data under the SNF QRP as a result of the policies
in this final rule. Tables 19 and 22 provide our best estimate of the
possible changes in Medicare payments under the SNF VBP as a result of
the policies in this final rule.
       Table 20--Accounting Statement: Classification of Estimated
   Expenditures, From the 2019 SNF PPS Fiscal Year to the 2020 SNF PPS
                               Fiscal Year
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
Annualized Monetized Transfers.........  $851 million. *
From Whom To Whom?.....................  Federal Government to SNF
                                          Medicare Providers.
------------------------------------------------------------------------
* The net increase of $851 million in transfer payments is a result of
  the market basket increase of $851 million.
[[Page 38831]]
Table 21--Accounting Statement: Estimated Cost To Update the SNF Quality
                            Reporting Program
------------------------------------------------------------------------
                Category                               Cost
------------------------------------------------------------------------
Cost for SNFs to Submit Data for QRP...  $29 million.*
------------------------------------------------------------------------
* Costs associated with the submission of data for the QRP will occur in
  FY 2021 and likely continue in the future years.
Table 22--Accounting Statement: Classification of Estimated Expenditures
                     for the FY 2020 SNF VBP Program
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
Annualized Monetized Transfers.........  $320.4 million.*
From Whom To Whom?.....................  Federal Government to SNF
                                          Medicare Providers.
------------------------------------------------------------------------
* This estimate does not include the two percent reduction to SNFs'
  Medicare payments (estimated to be $527.4 million) required by
  statute.
9. Conclusion
    This final rule sets forth updates of the SNF PPS rates contained
in the SNF PPS final rule for FY 2019 (83 FR 39162). Based on the
above, we estimate that the overall payments for SNFs under the SNF PPS
in FY 2020 are projected to increase by approximately $851 million, or
2.4 percent, compared with those in FY 2019. We estimate that in FY
2020 under PDPM, SNFs in urban and rural areas will experience, on
average, a 1.7 percent increase and 6.2 percent increase, respectively,
in estimated payments compared with FY 2019. Providers in the urban
Outlying region will experience the largest estimated increase in
payments of approximately 60.5 percent. Providers in the urban Middle
Atlantic region will experience the largest estimated decrease in
payments of 0.8 percent.
B. Regulatory Flexibility Act Analysis
    The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, non-profit organizations, and small
governmental jurisdictions. Most SNFs and most other providers and
suppliers are small entities, either by reason of their non-profit
status or by having revenues of $27.5 million or less in any 1 year. We
utilized the revenues of individual SNF providers (from recent Medicare
Cost Reports) to classify a small business, and not the revenue of a
larger firm with which they may be affiliated. As a result, for the
purposes of the RFA, we estimate that almost all SNFs are small
entities as that term is used in the RFA, according to the Small
Business Administration's latest size standards (NAICS 623110), with
total revenues of $27.5 million or less in any 1 year. (For details,
see the Small Business Administration's website at http://www.sba.gov/category/navigation-structure/contracting/contracting-officials/eligibility-size-standards). In addition, approximately 20 percent of
SNFs classified as small entities are non-profit organizations.
Finally, individuals and states are not included in the definition of a
small entity.
    This final rule sets forth updates of the SNF PPS rates contained
in the SNF PPS final rule for FY 2019 (83 FR 39162). Based on the
above, we estimate that the aggregate impact for FY 2020 will be an
increase of $851 million in payments to SNFs, resulting from the SNF
market basket update to the payment rates. While it is projected in
Table 18 that most providers would experience a net increase in
payments, we note that some individual providers within the same region
or group may experience different impacts on payments than others due
to the distributional impact of the FY 2020 wage indexes, PDPM
transition and the degree of Medicare utilization.
    Guidance issued by the Department of Health and Human Services on
the proper assessment of the impact on small entities in rulemakings,
utilizes a cost or revenue impact of 3 to 5 percent as a significance
threshold under the RFA. In their March 2019 Report to Congress
(available at http://medpac.gov/docs/default-source/reports/mar19_medpac_ch8_sec.pdf), MedPAC states that Medicare covers
approximately 11 percent of total patient days in freestanding
facilities and 19 percent of facility revenue (March 2019 MedPAC Report
to Congress, 197). As a result, for most facilities, when all payers
are included in the revenue stream, the overall impact on total
revenues should be substantially less than those impacts presented in
Table 18. As indicated in Table 18, the effect on facilities is
projected to be an aggregate positive impact of 2.4 percent for FY
2020. As the overall impact on the industry as a whole, and thus on
small entities specifically, is less than the 3 to 5 percent threshold
discussed previously, the Secretary has determined that this final rule
will not have a significant impact on a substantial number of small
entities for FY 2020.
    In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of an MSA and has fewer
than 100 beds. This final rule will affect small rural hospitals that
(1) furnish SNF services under a swing-bed agreement or (2) have a
hospital-based SNF. We anticipate that the impact on small rural
hospitals will be a positive impact. Moreover, as noted in previous SNF
PPS final rules (most recently, the one for FY 2019 (83 FR 39288)), the
category of small rural hospitals is included within the analysis of
the impact of this final rule on small entities in general. As
indicated in Table 18, the effect on facilities for FY 2020 is
projected to be an aggregate positive impact of 2.4 percent. As the
overall impact on the industry as a whole is less than the 3 to 5
percent threshold discussed above, the Secretary has determined that
this final rule will not have a significant impact on a substantial
number of small rural hospitals for FY 2020.
C. Unfunded Mandates Reform Act Analysis
    Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2019, that
threshold is approximately
[[Page 38832]]
$154 million. This final rule will impose no mandates on state, local,
or tribal governments or on the private sector.
D. Federalism Analysis
    Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule (and subsequent final
rule) that imposes substantial direct requirement costs on state and
local governments, preempts state law, or otherwise has federalism
implications. This final rule will have no substantial direct effect on
state and local governments, preempt state law, or otherwise have
federalism implications.
E. Reducing Regulation and Controlling Regulatory Costs
    Executive Order 13771, entitled ``Reducing Regulation and
Controlling Regulatory Costs,'' was issued on January 30, 2017 and
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.''
This final rule is considered an E.O. 13771 regulatory action. We
estimate the rule generates $20.68 million in annualized costs in 2016
dollars, discounted at 7 percent relative to year 2016 over a perpetual
time horizon. Details on the estimated costs of this rule can be found
in the preceding and subsequent analyses.
F. Congressional Review Act
    This final regulation is subject to the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress
and the Comptroller General for review.
G. Regulatory Review Costs
    If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this final rule, we
should estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review the rule, we assume that the total number of unique
commenters on last year's proposed rule will be the number of reviewers
of this year's proposed rule. We acknowledge that this assumption may
understate or overstate the costs of reviewing this rule. It is
possible that not all commenters reviewed last year's rule in detail,
and it is also possible that some reviewers chose not to comment on the
proposed rule. For these reasons, we thought that the number of past
commenters is a fair estimate of the number of reviewers of this rule.
In the FY 2020 SNF PPS proposed rule (84 FR 17689), we welcomed any
comments on the approach in estimating the number of entities which
will review the proposed rule.
    We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of the proposed rule, and
therefore, for the purposes of our estimate we assume that each
reviewer reads approximately 50 percent of the rule. We sought comments
on this assumption in the FY 2020 SNF PPS proposed rule (84 FR 17689).
    Using the wage information from the BLS for medical and health
service managers (Code 11-9111), we estimate that the cost of reviewing
this rule is $109.36 per hour, including overhead and fringe benefits
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average
reading speed, we estimate that it would take approximately 4 hours for
the staff to review half of the proposed rule. For each SNF that
reviews the rule, the estimated cost is $437.44 (4 hours x $109.36).
Therefore, we estimate that the total cost of reviewing this regulation
is $27,559 ($437.44 x 63 reviewers).
    In accordance with the provisions of Executive Order 12866, this
final rule was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 409
    Health facilities, Medicare.
42 CFR Part 413
    Diseases, Health facilities, Medicare, Reporting and recordkeeping
requirements.
    For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 409--HOSPITAL INSURANCE BENEFITS
0
1. The authority citation for part 409 continues to read as follows:
    Authority:  42 U.S.C. 1302 and 1395hh.
Sec.  409.30   [Amended]
0
2. Section 409.30 is amended in the introductory text--
0
a. By removing the phrase ``the 5-day assessment'' and adding in its
place the phrase ``the initial Medicare assessment''; and
0
b. By removing the phrase ``must occur'' and adding in its place the
phrase ``must be set for''.
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT
RATES FOR SKILLED NURSING FACILITIES; PAYMENT FOR ACUTE KIDNEY
INJURY DIALYSIS
0
3. The authority citation for part 413 continues to read as follows:
    Authority:  42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a),
(i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww; and sec.
124 of Pub. L. 106-113, 113 Stat. 1501A-332; sec. 3201 of Pub. L.
112-96, 126 Stat. 156; sec. 632 of Pub. L 112-240, 126 Stat. 2354;
sec. 217 of Pub. L. 113-93, 129 Stat. 1040; and sec. 204 of Pub. L.
113-295, 128 Stat. 4010; and sec. 808 of Pub. L. 114-27, 129 Stat.
362.
0
4. Section 413.343 is amended by revising paragraph (b) to read as
follows:
Sec.  413.343   Resident assessment data.
* * * * *
    (b) Assessment schedule. In accordance with the methodology
described in Sec.  413.337(c) related to the adjustment of the Federal
rates for case-mix, SNFs must submit assessments according to an
assessment schedule. This schedule must include performance of an
initial Medicare assessment with an assessment reference date that is
set for no later than the 8th day of posthospital SNF care, and such
other interim payment assessments as the SNF determines are necessary
to account for changes in patient care needs.
* * * * *
0
5. Section 413.360 is amended by revising paragraphs (a) and (d)(1) and
(4) to read as follows:
Sec.  413.360   Requirements under the Skilled Nursing Facility (SNF)
Quality Reporting Program (QRP).
    (a) Participation start date. Beginning with the FY 2018 program
year, a SNF must begin reporting data in accordance with paragraph (b)
of this section no later than the first day of the calendar quarter
subsequent to 30 days after the date on its CMS Certification Number
(CCN) notification letter, which designates the SNF as operating in the
CMS designated data submission system. For purposes of this section, a
program year is the fiscal year in which the market basket percentage
described in Sec.  413.337(d) is reduced by two percentage points if
the SNF does not report data in accordance with paragraph (b) of this
section.
* * * * *
    (d) * * *
[[Page 38833]]
    (1) SNFs that do not meet the requirements in paragraph (b) of this
section for a program year will receive a notification of non-
compliance sent through at least one of the following methods: The CMS
designated data submission system, the United States Postal Service, or
via an email from the Medicare Administrative Contractor (MAC). A SNF
may request reconsideration no later than 30 calendar days after the
date identified on the letter of non-compliance.
* * * * *
    (4) CMS will notify SNFs, in writing, of its final decision
regarding any reconsideration request through at least one of the
following methods: CMS designated data submission system, the United
States Postal Service, or via email from the CMS Medicare
Administrative Contractor (MAC).
* * * * *
    Dated: July 26, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: July 26, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-16485 Filed 7-30-19; 4:15 pm]
 BILLING CODE 4120-01-P