Medicaid Program; Methods for Assuring Access to Covered Medicaid Services-Rescission

 
CONTENT
Federal Register, Volume 84 Issue 135 (Monday, July 15, 2019)
[Federal Register Volume 84, Number 135 (Monday, July 15, 2019)]
[Proposed Rules]
[Pages 33722-33732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14943]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 447
[CMS-2406-P2]
RIN 0938-AT41
Medicaid Program; Methods for Assuring Access to Covered Medicaid
Services--Rescission
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would remove the regulatory text that sets
forth the current required process for states to document whether
Medicaid payments in fee-for-service systems are sufficient to enlist
enough providers to assure beneficiary access to covered care and
services consistent with the Medicaid statute. States have raised
concerns over the administrative burden associated with the current
regulatory requirements. While we believe the process described in the
current regulatory text is a valuable tool for states to use to
demonstrate the sufficiency of provider payment rates, we believe
mandating states to collect the specific information as described
excessively constrains state freedom to administer the program in the
manner that is best for the state and Medicaid beneficiaries in the
state.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 13,
2019.
ADDRESSES: In commenting, please refer to file code CMS-2406-P2.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
    1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
    2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-2406-P2, P.O. Box 8016,
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-2406-P2, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Jeremy Silanskis, (410) 786-1592.
SUPPLEMENTARY INFORMATION:  Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following website as soon as possible after they have been
received: http://www.regulations.gov. Follow the search instructions on
that website to view public comments.
I. Background
    Section 1902(a)(30)(A) of the Social Security Act (the Act)
requires states to
[[Page 33723]]
assure that payments are consistent with efficiency, economy, and
quality of care and are sufficient to enlist enough providers so that
care and services are available under the plan at least to the extent
that such care and services are available to the general population in
the geographic area. In the November 2, 2015 Federal Register (80 FR
67576), we published the ``Medicaid Program; Methods for Assuring
Access to Covered Medicaid Services'' final rule with comment period
(``2015 final rule with comment period'') that outlined a data-driven
process for states to document their compliance with section
1902(a)(30)(A) of the Act. The 2015 final rule with comment period
included a new Sec.  447.203(b)(1) through (8), revisions to Sec.
447.204, and a new Sec.  447.205(d)(2)(iv). These regulations
established that states must develop and submit to CMS an access
monitoring review plan (AMRP), that is updated at least every 3 years,
for the following services: (1) Primary care (including those provided
by a physician, federally qualified health center, clinic or dental
care); (2) physician specialist services (for example, cardiology,
urology, radiology); (3) behavioral health services (including mental
health and substance use disorder); (4) pre- and post-natal obstetric
services, (including labor and delivery); (5) home health services; (6)
any additional types of services for which a review is required under
Sec.  447.203(b)(6) because of a proposed payment rate reduction or
restructuring; (7) additional types of services for which the state or
CMS has received a significantly higher than usual volume of
beneficiary, provider or other stakeholder access complaints for a
geographic area; and (8) additional types of services selected by the
state.
    Furthermore, under Sec.  447.204(a) through (c), when proposing to
reduce or restructure Medicaid payment rates, states must consider the
data collected through the AMRP and undertake a public process that
solicits input on the potential impact of proposed reduction or
restructuring of Medicaid payment rates on beneficiary access to care.
States must submit related analysis to CMS along with any proposed rate
reduction or restructuring state plan amendment (SPA), and we may
disapprove such proposed SPA that does not include documentation
supporting compliance with the required AMRP review and public process.
Under Sec.  447.204(d), we may take a compliance action against a state
to remedy an access issue. The initial AMRP submissions were due to us
on October 1, 2016, as provided in the final rule, ``Medicaid Program;
Deadline for Access Monitoring Review Plan Submissions,'' published in
the April 12, 2016 Federal Register (81 FR 21479). We received AMRP
submissions from all states, and the submissions are available on the
Medicaid.gov website at https://www.medicaid.gov/medicaid/access-to-care/review-plans/index.html.
    Finally, under Sec.  447.205(d)(2)(iv), states may provide the
required public notice of any significant proposed change in its
methods and standards for setting payment rates for services on a state
public website that meets the standards specified in that paragraph.
    A number of states expressed concern regarding the administrative
burden associated with the regulatory requirements, particularly those
states with very high beneficiary enrollment in managed care and a
correspondingly limited number of beneficiaries receiving care through
a fee-for-service delivery system. States have mentioned that they must
utilize a significant amount of staff resources to develop the AMRPs
and conduct the required analysis when, because of the relatively small
population in fee-for-service, it will result in program data that is
not reflective of the state's overall care delivery system and
therefore is not well suited to evaluating access for the entire
population of Medicaid beneficiaries in the state. For instance, states
have discussed that remaining fee-for-service populations are often
dually eligible for Medicare and Medicaid with Medicaid only being the
secondary payer for most services provided to these individuals.
Similarly, remaining fee-for-service populations may reside in long-
term care facilities and because Medicaid is often the primary payer of
long-term care services, and as such, typically sets the market for
these services, the types of data comparisons required by the AMRPs are
of limited utility. Other populations remaining in fee-for-service may
have reduced packages of services based on specific needs, and these
populations are often so small or require such specialized care that
their needs may not be meaningfully compared to the general population.
Additionally, some states have noted that their managed care contracts
require participating providers to also participate in their fee-for-
service program. Even states with limited managed care enrollment have
raised concerns about what they consider to be burdensome standards and
unsustainable processes and, through the National Association of
Medicaid Directors, have requested to work with CMS to develop
meaningful standards and a process that effectively implements section
1902(a)(30)(A) of the Act.
    In attempt to address some of the states' concerns regarding undue
administrative burden, in the March 23, 2018 Federal Register (83 FR
12696), we published a proposed rule that would have exempted states
with at least 85 percent of their Medicaid population enrolled in
comprehensive, risk-based managed care from the regulatory requirements
in Sec. Sec.  447.203(b)(1) through (6) and 447.204(a) through (c). In
addition, the proposed rule would have exempted from the regulatory
requirements in Sec. Sec.  447.203(b)(6) and 447.204(a) through (c)
state proposals to reduce rates or restructure payments where the
overall reduction is 4 percent or less of overall spending within the
affected state plan service category for a single state fiscal year
(SFY) and 6 percent or less over 2 consecutive SFYs. In the responses
that we received during the public comment period, an overwhelming
number of commenters raised concerns that the exemption thresholds were
arbitrarily set without data to support them. While we maintain that
the thresholds are supportable, we have decided not to finalize the
proposed exemptions, and instead to set out a new approach to
understanding access and ensuring statutory compliance while
eliminating unnecessary burden on states.
    We have relied on states to analyze access to care data and develop
procedures to monitor data through updates to the AMRPs. While the
AMRPs can serve as an overall structure for states to monitor access
data, including after rate reductions or restructurings, similar
information can be presented by states through the SPA submission
process to demonstrate compliance with the statute without the need to
develop and maintain AMRPs as currently required under the regulations.
Additionally, apart from the SPA submission process, states continue to
be obligated to ensure their rates are sufficient to maintain
compliance with section 1902(a)(30)(A) of the Act. If the regulatory
amendments in this proposed rule are finalized, we would expect to
issue subregulatory guidance concurrently with the publication of the
final rule through a letter to State Medicaid Directors to provide
information on data and analysis that states will submit with SPAs to
support compliance with section 1902(a)(30)(A) of the Act. We
anticipate that this guidance would provide states flexibility to
select the types of data they would use to demonstrate the sufficiency
of payment rates. Such data
[[Page 33724]]
might include: Rate comparisons; ratios of participating providers to
total providers in the geographic area; ratios of participating
providers to beneficiaries in the geographic area; available
transportation in the geographic area; direct comparisons of access for
Medicaid beneficiaries to that of the general population in the
geographic area; and provider, beneficiary, and other stakeholder
complaints and recommendations for resolution of such complaints. We
expect that the guidance would remind states of their ongoing
obligation to ensure sufficient payment rates and that they must
demonstrate with the information they provide through SPAs that the
proposed rates or rate structure would satisfy the requirements of the
statute, including section 1902(a)(30)(A) of the Act.
    In addition, in partnership with states, we are renewing our
efforts and commitment to develop a data-driven strategy to understand
access to care in the Medicaid program across fee-for-service and
managed care delivery systems, as well as in home and community-based
services waiver programs. This new strategy will focus on developing a
more uniform methodology for analyzing Medicaid access data for all
states and will be led by us working in partnership with states and
other stakeholders. We will use this analysis to inform our approval
decisions and to set out new policies, as necessary, to improve
beneficiary access to care and services in the Medicaid program. In
conjunction with the 2015 final rule with comment period, we also
published a Request for Information (RFI) in the Federal Register (80
FR 67377) in which we sought public input to inform the potential
development of standards with regard to Medicaid beneficiaries' access
to covered services under the Medicaid program. The majority of
responses to the RFI were supportive of the concept of more
standardized access measures across states and delivery systems, at
that time however, we did not believe we had the necessary data at the
federal level to move forward with developing such measures. Since
2015, we have improved data available at the federal level through the
Transformed Medicaid Statistical Information System (T-MSIS), which is
a significant expansion of the previously available information from
the Medicaid Statistical Information System (MSIS) and have a better
understanding of how such data may be used to monitor access in
Medicaid. Additionally, we have been working extensively with states,
through a vendor, to identify best practices and develop standardized
templates that can be used to analyze access. We hope to build upon
these efforts as part of the new strategy.
II. Provisions of the Proposed Regulations
    We are proposing to remove Sec.  447.203(b), but leave in place the
requirement in Sec.  447.203(a) for states to maintain documentation of
payment rates and make that available to us upon request. In addition,
we propose to remove Sec.  447.204(b) through (c) to remove the
regulatory requirements for the process states must follow prior to the
submission of a SPA that proposes to reduce or restructure Medicaid
service payment rates. We are also proposing to remove Sec.
447.204(d), which specifies actions we could take to remedy an access
issue, as this provision was intended to address issues that arose
based on the state's access monitoring review procedures that we are
now proposing to no longer require. We would continue to have authority
to take compliance action or other remedial action if we determine that
a state is not in compliance with section 1902(a)(30)(A) of the Act.
The proposal would leave in place the opening sentence of the current
requirement in Sec.  447.204(a), which is a restatement of the
statutory language of section 1902(a)(30)(A) of the Act.
    Although this proposed rule would remove the regulatory process
requirements for states to develop and update an AMRP and to submit
certain access analysis when proposing to reduce or restructure
provider payment rates, states still would be obligated by the statute
to ensure Medicaid payment rates are sufficient to enlist enough
providers to assure that beneficiary access to covered care and
services are available under the plan at least to the extent such care
and services are available to the general population in the same
geographic area, particularly when reducing or restructuring Medicaid
payment rates through SPAs. States would still be required to submit
information and analysis to demonstrate compliance with section
1902(a)(30)(A) of the Act when submitting payment SPAs, and as
discussed above, we would expect to issue subregulatory guidance to
inform states on the types of information and data that we would
consider to be acceptable.
III. Collection of Information Requirements
    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et
seq.), we are required to provide 60-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. To fairly evaluate whether an information
collection should be approved by OMB, section 3506(c)(2)(A) of the PRA
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 estimate of the information collection
burden.
     The quality, utility, and clarity of the information to be
collected.
     Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
    In this proposed rule, we are soliciting public comment on each of
these issues for the following sections of this rule that would rescind
certain ``collection of information'' requirements as defined under 5
CFR 1320.3 of the PRA's implementing regulations.
A. Wage Estimates
    To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2017 National Occupational Employment and Wage
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). Note, this is updated wage information from the currently
approved information collection request (CMS-10391; OMB 0938-1134),
which used 2015 National Occupational Employment and Wage Estimates. In
this regard, Table 1 presents the mean hourly wage, the cost of fringe
benefits and overhead (calculated at 100 percent of salary), and the
adjusted hourly wage. This updated adjusted hourly wage information is
used for all of the estimated burden calculations in this proposed
rule.
[[Page 33725]]
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    We adjusted our employee hourly wage estimates by a factor of 100
percent. This was 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. We believe that doubling the hourly wage to
estimate total cost was a reasonably accurate estimation method.
B. Proposed Information Collection Requirements (ICRs)
    This rule does not propose any new collection of information
requirements. Instead, in the interest of consistency with Executive
Order 13771 (January 30, 2017), entitled, ``Reducing Regulation and
Controlling Regulatory Costs,'' this rule proposes to rescind the
collection of information requirements and burden that are set out
under the 2015 final rule with comment period (80 FR 67576). The
requirements and burden (with modification, as explained below) were
approved by OMB on April 29, 2016, under control number 0938-1134 (CMS-
10391). As noted previously, while we believe the process described in
the current regulatory text can be a valuable tool for states to use to
demonstrate the sufficiency of provider payment rates, because we have
no basis for determining how many states would continue to follow the
current AMRP process in whole or in part, we are assuming that all
states would opt to provide alternate evidence of compliance with
section 1902(a)(30)(A) of the Act and are therefore removing the burden
of the current AMRP requirements in its entirety. States were already
required to submit information on compliance with section
1902(a)(30)(A) of the Act prior to the 2015 final rule with comment
period. As the requirements and burden estimate under control number
0938-1134 (CMS-10391) only accounted for new burden associated with
2015 final rule with comment period, were are not accounting for burden
associated overall compliance with section 1902(a)(30)(A) of the Act
and information states may submit to demonstrate statutory compliance
as part of the SPA submission process if the proposal to rescind the
2015 requirements is finalized. Information and documentation states
submit in support of SPAs are covered within the procedural
requirements defined in 42 CFR part 430.
1. ICRs Regarding Access Monitoring Review Plans (Sec.  447.203(b))
    Current provisions at Sec.  447.203(b) require that states develop
and make publicly available an access monitoring review plan that
considers: Beneficiary needs, availability of care and providers, and
changes to beneficiary utilization of covered services.
    Section 447.203(b)(1) and (2) describes the minimum factors that
states must consider when developing an access monitoring review plan,
while Sec.  447.203(b)(3) requires that states include aggregate
percentage comparisons of Medicaid payment rates to other public
(including, as practical, Medicaid managed care rates) or private
health coverage rates within their state's geographic areas.
    Section 447.203(b)(4) describes the minimum content that must be in
included in the monitoring plan, including: The measures the state uses
to analyze access to care issues, how the measures relate to the
overarching framework, access issues that are discovered as a result of
the review, and the state Medicaid agency's recommendations on the
sufficiency of access to care based on the review.
    Section 447.203(b)(5) describes the timeframe for states to develop
the access monitoring review plan and complete the data review for the
following categories of services: Primary care, physician specialist
services, behavioral health, pre- and post-natal obstetric services
including labor and delivery, home health, any services for which the
state has submitted a state plan amendment to reduce or restructure
provider payments which changes could result in diminished access, and
additional services as determined necessary by the state or CMS. While
the initial access monitoring review plans have been completed, the
plan must be updated at least every 3 years, but no later than October
1 of the update year.
    In our currently approved information collection request (CMS-
10391; OMB 0938-1134), we estimated that the requirements to develop
and make the access monitoring review plans publicly available under
Sec.  447.203(b) and (b)(1) through (b)(5) for the specific categories
of Medicaid services will affect each of the 50 state Medicaid programs
and the District of Columbia (51 total respondents). Using the
previously derived estimates of burden hours and updated adjusted
hourly wage information, we now estimate that it will take: 80 hr at
$47.14/hr for a research assistant staff to gather data, 80 hr at
$90.20/hr for an information analyst staff to analyze the data, 100 hr
at $89.84/hr for management analyst staff to update the content of the
access review monitoring plan, 40 hr at $70.28/hr for business
operations specialist staff to publish the access monitoring review
plan, and 10 hr at $118.70/hr for managerial staff to review and
approve the access monitoring review plan. A demonstrated below in
Tables 2A and 2B, we estimate a burden reduction or savings of 15,810
hr (total) at a cost of $1,222,439 (total) or $23,969 (per state).
    Please note that the 2015 final rule with comment period set out a
burden of 5,270 hr which divided the total number of respondents (51
states) across 3 years (17 states per year) to equal 17 states x 310 hr
per response. In this rule we propose to adjust the number of
respondents from 17 to 51 to capture the total number of respondents
across the 3 year period, resulting in a difference of -10,540 hr
(5,270 hr-15,810 hr).
BILLING CODE 4120-01-P
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    Based on this rule's proposal to rescind the requirement for states
to update the access monitoring review plan at least every 3 years, we
are also removing the on-going or annual burden associated with the
access monitoring review plan. Consistent with our currently approved
estimates, we believe that the average ongoing burden is likely to be
the same as the average initial burden since states will need to re-run
the data, determine whether to add or drop measures, consider public
feedback, and write-up new conclusions based on the information they
review.
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2. ICRs Regarding Ongoing Monitoring (Sec.  447.203(b)(6)(ii))
    Section 447.203(b)(6)(ii) requires that states have procedures
within the access monitoring review plan to monitor continued access
after implementation of a SPA that reduces or restructures payment
rates. The monitoring procedures must be in place for a period of at
least three years following the effective date of the SPA. The ongoing
burden associated with the requirements under Sec.  447.203(b)(6)(ii)
is the time and effort it would take each of the state Medicaid
programs to monitor continued access following the implementation of a
SPA that reduces or restructures payment rates.
    In our currently approved information collection request (CMS-
10391; OMB 0938-1134), we estimated that in each SPA submission cycle,
states would submit 22 SPAs to implement rate changes or restructure
provider payments based on the number of submissions received in FY
2010.
    Using the previously approved estimates of burden hours and updated
adjusted hourly wage information, we now estimate that it will take, on
average: 40 hr at $89.84/hr for management analyst staff to develop the
monitoring procedures, 24 hr at $89.84/hr for management analyst staff
to periodically review the monitoring results, and 3 hr at $118.70/hr
for management staff to review and approve the monitoring procedures.
As demonstrated below in Tables 4A and 4B, we estimate a burden
reduction or savings of 1,474 hr (total) at a cost of $134,329 (total)
or $6,106 (per state).
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[[Page 33727]]
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3. ICRs Regarding Ongoing Input (Sec.  447.203(b)(7))
    The current provision at Sec.  447.203(b)(7) requires that states
have a mechanism for obtaining ongoing beneficiary, provider, and
stakeholder input on access to care issues such as: Hotlines, surveys,
ombudsman, or other equivalent mechanisms. States must promptly respond
to public input with an appropriate investigation, analysis, and
response. They also must maintain records of beneficiary input and the
nature of the state response.
    In our currently approved information collection request (CMS-
10391; OMB 0938-1134), we estimated that the requirement to develop
mechanisms for ongoing feedback would affect each of the 50 state
Medicaid programs and the District of Columbia (51 total respondents).
    Using the previously approved estimates of burden hours and updated
adjusted hourly wage information, we now also estimate that it would
take an average of: 100 hr at $89.84/hr for management analyst staff to
develop the feedback effort and 5 hr at $118.70 for managerial staff to
review and approve the feedback effort. As demonstrated below in Tables
5A and 5B, we estimate a burden reduction or savings of 5,355 hr
(total) at a cost of $488,453 (total) or $9,578 (per state).
    Please note that the 2015 final rule with comment period had set
out a burden of 1,785 hr which divided the total number of respondents
(51 states) across 3 years (17 states per year) to equal 17 states x
105 hr per response. In this rule, we propose to adjust the number of
respondents from 17 to 51 to capture the total number of respondents
across the 3-year period, resulting in a difference of -3,570 hr (1,785
hr-5,355 hr).
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    The ongoing burden associated with the requirements under Sec.
447.203(b)(7) is the time and effort it would take each of the 50 state
Medicaid programs and the District of Columbia (51 total respondents)
to monitor beneficiary feedback mechanisms. The overall effort
associated with monitoring the feedback is primarily incurred by the
analysts who will gather, review and make recommendations for and
conduct follow-up on the feedback. We estimate that it will take an
average of: 75 hr at $89.84/hr for management analyst staff to monitor
feedback results and 5 hr at $118.70/hr for managerial staff to review
and approve the feedback effort. As demonstrated below in Tables 6A and
6B, we estimate a burden reduction or savings of 4,080 hr (total) at a
cost of $373,907 (total) or $7,332 (per state).
[GRAPHIC] [TIFF OMITTED] TP15JY19.009
[[Page 33728]]
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4. ICRs Regarding Corrective Action Plan (Sec.  447.203(b)(8))
    Current Sec.  447.203(b)(8) requires that states submit to CMS a
corrective action plan should access issues be discovered through the
access monitoring processes.
    In our currently approved information collection request (CMS-
10391; OMB 0938-1134), we estimated that a maximum of 10 states may
identify access issues per year. The one-time burden is the time and
effort it would take 10 state Medicaid programs to develop and
implement corrective action plans.
    Using the previously approved estimates of burden hours and updated
adjusted hourly wage information, we estimate that it would take an
average of: 20 hr at $89.84/hr for management analyst staff to identify
issues requiring corrective action, 40 hr at $89.84/hr for management
analyst staff to develop the corrective action plans, and 3 hr at
$118.70/hr for managerial staff to review and approve the corrective
action plans. As demonstrated below in Tables 7A and 7B, we estimate a
burden reduction or savings of 630 hr (total) at a cost of $57,465
(total) or $5,747 (per state).
    Please note that the 2015 final rule with comment period had set
out a burden of 208 hr which was corrected in the Supporting Statement
(approved by OMB on February 2, 2016) to reflect 630 hr, resulting in a
difference of plus 422 hr.
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[GRAPHIC] [TIFF OMITTED] TP15JY19.012
5. ICRs Regarding Public Process To Engage Stakeholders (Sec.
447.204(a)(1) and (2))
    Current Sec.  447.204(a)(1) and (2) require that states consider
(when proposing to reduce or restructure Medicaid payment rates) the
data collected through current Sec.  447.203 and undertake a public
process that solicits input on the potential impact of the proposed
reduction or restructuring of Medicaid service payment rates on
beneficiary access to care.
    In our currently approved information collection request (CMS-
10391; OMB 0938-1134), we estimated that approximately 22 states would
develop and implement rate changes that would require a public process.
Using the previously approved estimates of burden hours and updated
adjusted hourly wage information, we also estimate that it would take
an average of: 20 hr at $89.84/hr for management analyst staff to
develop the public process and 3 hr at $118.70/hr for managerial staff
to review and approve the public process. As demonstrated below in
Tables 8A and 8B, we estimate a burden reduction or savings of 506 hr
(total) at a cost of $47,364 (total) or $2,153 (per state).
    Please note that the 2015 final rule with comment period had set
out a burden of 168 hr which was corrected in the Supporting Statement
(approved by OMB on February 2, 2016) to reflect 506 hr, resulting in a
difference of plus 338 hr.
[GRAPHIC] [TIFF OMITTED] TP15JY19.013
[[Page 33729]]
    The ongoing burden associated with the current requirements under
Sec.  447.204 is the time and effort it would take 22 state Medicaid
programs to oversee a public process. We estimate that it would take an
average of: 40 hr at $89.84/hr for management analyst staff to oversee
the public process and 3 hr at $118.70/hr for managerial staff to
review and approve the public process. As demonstrated below in Tables
9A and 9B, we estimate a burden reduction or savings of 946 hr (total)
at a cost of $86,893 (total) or $3,950 (per state).
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C. Summary of Proposed Collection of Information Requirements and
Burden
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[[Page 33730]]
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 BILLING CODE 4120-01-C
D. Submission of PRA-Related Comments
    We have submitted a copy of this proposed rule to OMB for its
review of the rule information collection and recordkeeping
requirements. The requirements are not effective, if finalized, until
they have been approved by OMB.
    We invite public comments on these information collection
requirements, and particularly on submission frequency and burden hours
per response. If you wish to comment, please identify the rule (CMS-
2406-P2), the CMS ID number (CMS-10391), and the OMB control number
(0938-1134).
    To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Email your request, including your address, phone number, OMB
control number, and CMS document identifier (CMS-10391), to
[email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.
    See this rule's DATES and ADDRESSES sections for the comment due
date and for additional instructions.
IV. Response to Comments
    Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Regulatory Impact Statement
A. Statement of Need
    We are concerned about the unnecessary administrative burden
experienced by state Medicaid agencies in meeting the requirements of
Sec.  447.203(b)(1) through (8) and Sec.  447.204(b) through (d), when
we believe that similar information could be presented by states when
necessary to demonstrate compliance with the statute without the need
to develop and maintain AMRPs as currently required under the
regulations. This proposed rule impacts states' documentation of
compliance with section 1902(a)(30)(A) of the Act and would provide
burden relief to all states. Although this proposed rule would remove
the regulatory process requirements for states to develop and update an
AMRP and to submit an access analysis when proposing to reduce or
restructure provider payment rates in circumstances that could result
in
[[Page 33731]]
diminished access, states are still obligated by the statute to ensure
Medicaid payment rates are sufficient to enlist enough providers to
assure that beneficiary access to covered care and services are
available under the plan at least to the extent such care and services
are available to the general population in the same geographic area,
particularly when reducing or restructuring Medicaid payment rates
through SPAs. This proposed rule would not remove, or otherwise limit,
the states' obligation to comply with the statute, but would allow
states greater flexibility in the way in which they demonstrate such
compliance.
B. Overall Impact
    We have examined the impacts of this proposed 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 (Pub. L. 96-
354, enacted on September 19, 1980) (RFA), section 1102(b) of the Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4,
enacted on March 22, 1995) (UMRA), 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). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). This proposed rule is not economically significant with an
overall estimated reduced reporting burden of $3,633,289.
C. Anticipated Effects
1. Effects on State Medicaid Programs
    We anticipate effects on state Medicaid programs as they would no
longer be required to maintain and update the access monitoring review
plans required under the current regulations. Importantly, the
provisions of this proposed rule remove the regulatory procedural
requirements for demonstrating access to care. However, states would
not be exempt from the statutory requirements under section
1902(a)(30)(A) of the Act and would continue to be required to ensure
access is consistent with the Act generally, and especially when
seeking to reduce or restructure Medicaid payment rates.
2. Effects on Small Business and Providers
    We do not anticipate effects on small businesses and providers
because states are still required to comply with section 1902(a)(30)(A)
of the Act and will need to demonstrate such compliance when they
submit a SPA to reduce or restructure payment rates. We do not
anticipate our SPA approval decisions will be impacted by removing the
process requirements included in these regulations, as states will
still need to demonstrate compliance with the Act.
3. Effects on the Medicaid Program
    The estimated fiscal impact on the Medicaid program from the
implementation of the proposed rule is estimated to be a net savings to
Medicaid state agencies. This will have an effect on state
administrative expenditures, which have been quantified in the
collection of information requirements described previously in this
proposed rule. While we acknowledge there will still be some level of
state administrative burden associated with documenting compliance with
the statute, we believe it is likely to be significantly less than the
burden associated with carrying out the procedural requirements
included in the current regulations, and are seeking comment
specifically on this issue. We do not anticipate implementing this
proposed rule would have an impact on a state's Medicaid rates.
    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. The great majority of hospitals and most
other health care providers and suppliers are small entities, either by
being nonprofit organizations or by meeting the SBA definition of a
small business (having revenues of less than $7.5 million to $38.5
million in any one year). Individuals and states are not included in
the definition of a small entity. As previously stated, we do not
anticipate any effect on small entities.
    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 603 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 a metropolitan
statistical area and has fewer than 100 beds. This rule will not have a
significant impact on the operations of a substantial number of small
rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 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 2018, that
threshold is approximately $150 million. This rule does not contain
mandates that will impose spending costs on state, local, or tribal
governments in the aggregate, or by the private sector, in excess of
the threshold.
    Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule that imposes
substantial direct requirement costs on state and local governments,
preempts state law, or otherwise has Federalism implications. This rule
does not have a substantial direct cost impact on state or local
governments.
D. Alternatives Considered
    We considered, and previously proposed, setting a threshold for
exemption from certain regulatory requirements for states with at least
an 85 percent enrollment rate in comprehensive risk-based managed care.
We also considered setting a threshold for proposed payment rate
reductions that would be considered ``nominal'' and not subject to
these regulatory requirements. After further consideration of these
alternatives, we determined that neither alternative provided
sufficient administrative
[[Page 33732]]
burden relief for states and that implementing the thresholds could be
administratively challenging for both states and CMS, particularly in
marginal cases where the state's managed care enrollment percentage or
the percentage rate change approached the applicable threshold.
Therefore, we believe that removing the regulatory requirements is the
best course of action as we move forward in the development and
implementation of a comprehensive approach to monitoring access across
Medicaid delivery systems.
E. Reducing Regulation and Controlling Regulatory Costs
    Executive Order 13771, titled Reducing Regulation and Controlling
Regulatory Costs, was issued on January 30, 2017. This proposed rule is
expected to be an E.O. 13771 deregulatory action. We estimate that this
rule generates $3.63 million in annualized cost savings, discounted at
7 percent relative to year 2016, over a perpetual time horizon. Details
on the estimated cost savings of this rule can be found in the
preceding analyses.
G. Conclusion
    In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 447
    Accounting, Administrative practice and procedure, Drugs, Grant
programs-health, Health facilities, Health professions, Medicaid,
Reporting and recordkeeping requirements, Rural areas.
    For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 447--PAYMENTS FOR SERVICES
0
1. The authority citation for part 447 is revised to read as follows:
    Authority: 42 U.S.C. 1302.
Sec.  447.203   [Amended]
0
2. Section 447.203 is amended by removing and reserving paragraph (b).
0
3. Section 447.204 is revised to read as follows:
Sec.  447.204   Medicaid provider participation and public process to
inform access to care.
    The agency's payments must be consistent with efficiency, economy,
and quality of care and sufficient to enlist enough providers so that
services under the plan are available to beneficiaries at least to the
extent that those services are available to the general population in
the geographic area.
    Dated: January 28, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: February 13, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
    Editorial Note: This document was received by the Office of the
Federal Register on July 10, 2019.
[FR Doc. 2019-14943 Filed 7-11-19; 11:15 am]
BILLING CODE 4120-01-P