Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Home Infusion Therapy Services Requirements

Published date30 June 2020
Citation85 FR 39408
Record Number2020-13792
SectionProposed rules
CourtCenters For Medicare & Medicaid Services
Federal Register, Volume 85 Issue 126 (Tuesday, June 30, 2020)
[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
                [Proposed Rules]
                [Pages 39408-39453]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-13792]
                [[Page 39407]]
                Vol. 85
                Tuesday,
                No. 126
                June 30, 2020
                Part IIIDepartment of Health and Human Services-----------------------------------------------------------------------Centers for Medicare & Medicaid Services-----------------------------------------------------------------------42 CFR Parts 409, 414, 424, et al.Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment
                System Rate Update; Home Health Quality Reporting Requirements; and
                Home Infusion Therapy Services Requirements; Proposed Rule
                Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 /
                Proposed Rules
                [[Page 39408]]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                42 CFR Parts 409, 414, 424, and 484
                [CMS-1730-P]
                RIN 0938-AU-06
                Medicare and Medicaid Programs; CY 2021 Home Health Prospective
                Payment System Rate Update; Home Health Quality Reporting Requirements;
                and Home Infusion Therapy Services Requirements
                AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
                ACTION: Proposed rule.
                -----------------------------------------------------------------------
                SUMMARY: This proposed rule would update the home health prospective
                payment system (HH PPS) payment rates and wage index for calendar year
                (CY) 2021. This proposed rule also proposes to make permanent the
                changes to the home health regulations regarding the use of technology
                in providing services under the Medicare home health benefit as
                described in the Medicare and Medicaid Programs; Revisions in Response
                to the COVID-19 Public Health Emergency interim final rule with comment
                period. This proposed rule also proposes to remove provisions related
                to test transmission of OASIS data by a new HHA, because the provision
                is now obsolete due to changes in our data submission system. This
                proposed rule discusses policies finalized in the CY 2020 HH PPS final
                rule with comment period regarding the permanent home infusion therapy
                services benefit for CY 2021, and proposes conforming regulations text
                changes excluding home infusion therapy services from coverage under
                the Medicare home health benefit. Additionally, this proposed rule
                discusses Medicare enrollment policies for qualified home infusion
                therapy suppliers.
                DATES: To be assured consideration, comments must be received at one of
                the addresses provided below, no later than 5 p.m. on August 31, 2020.
                ADDRESSES: In commenting, please refer to file code CMS-1730-P. 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-1730-P, P.O. Box 8013,
                Baltimore, MD 21244-8013.
                 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-1730-P, 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:
                 Hillary Loeffler, (410) 786-0456, for home health and home infusion
                therapy payment inquiries.
                 For general information about the Home Health Prospective Payment
                System (HH PPS), send your inquiry via email to:
                [email protected].
                 For general information about home infusion payment, send your
                inquiry via email to: [email protected].
                 For information about the Home Health Quality Reporting Program (HH
                QRP), send your inquiry via email to [email protected].
                 Mary Rossi-Coajou, 410-786-6051, for condition of participation
                (CoP) OASIS requirements.
                 Joseph Schultz, 410-786-2656, for information about home infusion
                therapy supplier enrollment requirements.
                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. Executive Summary
                A. Purpose
                1. Home Health Prospective Payment System (HH PPS)
                 This proposed rule would update the payment rates for home health
                agencies (HHAs) for calendar year (CY) 2021, as required under section
                1895(b) of the Social Security Act (the Act). This proposed rule would
                also set forth the case-mix weights under section 1895(b)(4)(A)(i) and
                (b)(4)(B) of the Act for 30-day periods of care in CY 2021; and the CY
                2021 fixed-dollar loss ratio (FDL) and the loss-sharing ratio for
                outlier payments (as required by section 1895(b)(5)(A) of the Act).
                This rule also proposes to adopt the revised OMB statistical area
                delineations as described in the September 14, 2018 OMB Bulletin No.
                18-04 \1\ for the labor market delineations used in the home health
                wage index, effective beginning in CY 2021. This rule also proposes a
                cap on wage index decreases in excess of 5 percent. This proposed rule
                would adopt the new OMB statistical areas and the 5 percent cap on wage
                index decreases under the statutory discretion afforded to the
                Secretary under sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act.
                Finally, this proposed rule proposes to permanently finalize the
                changes to Sec. 409.43(a) as finalized in ``Medicare and Medicaid
                Programs; Policy and Regulatory Revisions in Response to the COVID-19
                Public Health Emergency'' interim final rule with comment period (First
                COVID-19 PHE IFC) (85 FR 19230), to state that the plan of care must
                include any provision of remote patient monitoring or other services
                furnished via a telecommunications system.
                ---------------------------------------------------------------------------
                 \1\ On March 6, 2020, OMB issued the most recent OMB Bulletin
                No. 20-01. Bulletin No. 20-01 was not utilized for this proposed
                rulemaking.
                ---------------------------------------------------------------------------
                2. Home Health Quality Reporting Program (HH QRP)
                 We are not proposing any changes for the Home Health Quality
                Reporting Program.
                3. Changes to the CoP OASIS Requirements
                 This proposed rule would remove an obsolete provision that requires
                new HHAs that do not yet have a CMS certification number to conduct
                test OASIS data transmissions to the CMS data system as part of the
                initial certification process.
                4. Home Infusion Therapy Services
                 This proposed rule outlines the home infusion therapy policies
                finalized in
                [[Page 39409]]
                the CY 2020 HH PPS final rule with comment period (84 FR 60615), as
                required by section 1834(u) of the Act. This proposed rule includes
                conforming regulations text changes excluding home infusion therapy
                services from coverage under the Medicare home health benefit as
                required by the conforming amendment in section 5012(c)(3) of the 21st
                Century Cures Act.
                5. Enrollment Standards for Qualified Home Infusion Therapy Suppliers
                 This proposed rule would set out the Medicare provider enrollment
                policies for qualified home infusion therapy suppliers.
                B. Summary of the Provisions of This Rule
                1. Home Health Prospective Payment System (HH PPS)
                 In section III.A of this rule, we propose to set the LUPA
                thresholds and the case-mix weights for CY 2021 equal to the CY 2020
                LUPA thresholds and case-mix weights established for the first year of
                the PDGM. The PDGM is our new case-mix adjustment methodology to adjust
                payments for home health periods of care beginning on and after January
                1, 2020. The PDGM relies more heavily on clinical characteristics and
                other patient information to place patients into meaningful payment
                categories and eliminates the use of therapy service thresholds, as
                required by section 1895(b)(4)(B) of the Act, as amended by section
                51001(a)(3) of the Bipartisan Budget Act of 2018 (BBA of 2018).
                 Section III.B. of this rule proposes to adopt the OMB statistical
                area delineations outlined in a September 14, 2018, OMB bulletin No.
                18-04. This rule also proposes a transition with a 1-year cap on wage
                index decreases in excess of 5 percent, consistent with the policy
                being proposed for other Medicare payment systems. This proposed rule
                would adopt the new OMB statistical areas and the 5 percent cap on wage
                index decreases under the statutory discretion afforded to the
                Secretary under sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act.
                 In section III.C. of this rule, we propose to update the home
                health wage index, the CY 2021 national, standardized 30-day period of
                care payment amounts and the CY 2021 national per-visit payment amounts
                by the home health payment update percentage. The home health payment
                update percentage for CY 2021 is estimated to be 2.7 percent.
                Additionally, for CY 2021, this proposed rule proposes to maintain the
                fixed-dollar loss ratio at 0.63, as finalized for CY 2020.
                 Section III.D. of this proposed rule proposes to permanently
                finalize the changes to Sec. 409.43(a) as finalized in the first
                COVID-19 PHE IFC (85 FR 19230), to state that the plan of care must
                include any provision of remote patient monitoring or other services
                furnished via a telecommunications system and describe how the use of
                such technology is tied to the patient-specific needs as identified in
                the comprehensive assessment and will help to achieve the goals
                outlined on the plan of care.
                 Section IV. of this proposed rule discusses the HH QRP and proposed
                changes to the conditions of participation (CoP) OASIS requirements.
                 In sections V.A.1. and 2. of this proposed rule, we discuss the
                background and overview of the home infusion therapy services benefit,
                as well as review the payment policies we finalized in the CY HH PPS
                final rule with comment period for the CY 2021 implementation (84 FR
                60628). In section V.A.5. of this proposed rule, we propose technical
                regulations text changes to exclude home infusion therapy services from
                coverage under the Medicare home health benefit, as required by section
                5012(c)(3) of the 21st Century Cures Act, which amended section 1861(m)
                of the Act. In section V.B. of this proposed rule, we discuss proposed
                requirements regarding enrollment standards for qualified home infusion
                therapy suppliers.
                C. Summary of Costs, Transfers, and Benefits
                [[Page 39410]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.088
                III. Home Health Prospective Payment System
                A. Overview of the Home Health Prospective Payment System
                1. Statutory Background
                 The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted
                August 5, 1997), significantly changed the way Medicare pays for
                Medicare home health services. Section 4603 of the BBA mandated the
                development of the HH PPS. Until the implementation of the HH PPS on
                October 1, 2000, HHAs received payment under a retrospective
                reimbursement system. Section 4603(a) of the BBA mandated the
                development of a HH PPS for all Medicare-covered home health services
                provided under a plan of care (POC) that were paid on a reasonable cost
                basis by adding section 1895 of the Act, entitled ``Prospective Payment
                For Home Health Services.'' Section 1895(b)(1) of the Act requires the
                Secretary to establish a HH PPS for all costs of home health services
                paid under Medicare. Section 1895(b)(2) of the Act required that, in
                defining a prospective payment amount, the Secretary will consider an
                appropriate unit of service and the number, type, and duration of
                visits provided within that unit, potential changes in the mix of
                services provided within that unit and their cost, and a general system
                design that provides for continued access to quality services.
                 Section 1895(b)(3)(A) of the Act required the following: (1) The
                computation of a standard prospective payment amount that includes all
                costs for HH services covered and paid for on a reasonable cost basis,
                and that such amounts be initially based on the most recent audited
                cost report data available to the Secretary (as of the effective date
                of the 2000 final rule); and (2) the standardized prospective payment
                amount be adjusted to account for the effects of case-mix and wage
                levels among HHAs. Section 1895(b)(3)(B) of the Act requires the
                standard prospective payment amounts be annually updated by the home
                health applicable percentage increase. Section 1895(b)(4) of the Act
                governs the payment computation. Sections 1895(b)(4)(A)(i) and
                (b)(4)(A)(ii) of the Act require the standard prospective payment
                amount to be adjusted for case-mix and geographic differences in wage
                levels. Section 1895(b)(4)(B) of the Act requires the establishment of
                an appropriate case-mix change adjustment factor for significant
                variation in costs among different units of services. Similarly,
                section 1895(b)(4)(C) of the Act requires the establishment of area
                wage adjustment factors that reflect the relative level of wages, and
                wage-related costs applicable to home health services furnished in a
                geographic area compared to the applicable national average level.
                Under section 1895(b)(4)(C) of the Act, the wage adjustment factors
                used by the Secretary may be the factors used under section
                1886(d)(3)(E) of the Act. Section 1895(b)(5) of the Act gives the
                Secretary the option to make additions or adjustments to the payment
                amount otherwise paid in the case of outliers due to unusual variations
                in the type or amount of medically necessary care. Section 3131(b)(2)
                of the Affordable Care Act revised section 1895(b)(5) of the Act so
                that total outlier payments in a given year would not exceed 2.5
                percent of total payments projected or estimated. The provision also
                made permanent a 10 percent agency-level outlier payment cap.
                 In accordance with the statute, as amended by the BBA, we published
                a final rule in the July 3, 2000 Federal
                [[Page 39411]]
                Register (65 FR 41128) to implement the HH PPS legislation. The July
                2000 final rule established requirements for the new HH PPS for home
                health services as required by section 4603 of the BBA, as subsequently
                amended by section 5101 of the Omnibus Consolidated and Emergency
                Supplemental Appropriations Act for Fiscal Year 1999 (OCESAA), (Pub. L.
                105-277, enacted October 21, 1998); and by sections 302, 305, and 306
                of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
                1999, (BBRA) (Pub. L. 106-113, enacted November 29, 1999). The
                requirements include the implementation of a HH PPS for home health
                services, consolidated billing requirements, and a number of other
                related changes. The HH PPS described in that rule replaced the
                retrospective reasonable cost-based system that was used by Medicare
                for the payment of home health services under Part A and Part B. For a
                complete and full description of the HH PPS as required by the BBA, see
                the July 2000 HH PPS final rule (65 FR 41128 through 41214).
                 Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L.
                109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v)
                to the Act, requiring HHAs to submit data for purposes of measuring
                health care quality, and linking the quality data submission to the
                annual applicable payment percentage increase. This data submission
                requirement is applicable for CY 2007 and each subsequent year. If an
                HHA does not submit quality data, the home health market basket
                percentage increase is reduced by 2 percentage points. In the November
                9, 2006 Federal Register (71 FR 65935), we published a final rule to
                implement the pay-for-reporting requirement of the DRA, which was
                codified at Sec. 484.225(h) and (i) in accordance with the statute.
                The pay-for-reporting requirement was implemented on January 1, 2007.
                 The Affordable Care Act made additional changes to the HH PPS. One
                of the changes in section 3131 of the Affordable Care Act is the
                amendment to section 421(a) of the Medicare Prescription Drug,
                Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173,
                enacted on December 8, 2003) as amended by section 5201(b) of the DRA.
                Section 421(a) of the MMA, as amended by section 3131 of the Affordable
                Care Act, requires that the Secretary increase, by 3 percent, the
                payment amount otherwise made under section 1895 of the Act, for HH
                services furnished in a rural area (as defined in section 1886(d)(2)(D)
                of the Act) with respect to episodes and visits ending on or after
                April 1, 2010, and before January 1, 2016. Section 210 of the Medicare
                Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10) (MACRA)
                amended section 421(a) of the MMA to extend the 3 percent rural add-on
                payment for home health services provided in a rural area (as defined
                in section 1886(d)(2)(D) of the Act) through January 1, 2018. In
                addition, section 411(d) of MACRA amended section 1895(b)(3)(B) of the
                Act such that CY 2018 home health payments be updated by a 1 percent
                market basket increase. Section 50208(a)(1) of the BBA of 2018 again
                extended the 3 percent rural add-on through the end of 2018. In
                addition, this section of the BBA of 2018 made some important changes
                to the rural add-on for CYs 2019 through 2022.
                 Section 51001(a)(1)(B) of the Bipartisan Budget Act of 2018 (BBA of
                2018) amended section 1895(b) of the Act to require a change to the
                home health unit of payment to 30-day periods beginning January 1,
                2020. Section 51001(a)(2)(A) of the BBA of 2018 added a new subclause
                (iv) under section 1895(b)(3)(A) of the Act, requiring the Secretary to
                calculate a standard prospective payment amount (or amounts) for 30-day
                units of service, furnished that end during the 12-month period
                beginning January 1, 2020, in a budget neutral manner, such that
                estimated aggregate expenditures under the HH PPS during CY 2020 are
                equal to the estimated aggregate expenditures that otherwise would have
                been made under the HH PPS during CY 2020 in the absence of the change
                to a 30-day unit of service. Section 1895(b)(3)(A)(iv) of the Act
                requires that the calculation of the standard prospective payment
                amount (or amounts) for CY 2020 be made before the application of the
                annual update to the standard prospective payment amount as required by
                section 1895(b)(3)(B) of the Act.
                 Additionally, section 1895(b)(3)(A)(iv) of the Act requires that in
                calculating the standard prospective payment amount (or amounts), the
                Secretary must make assumptions about behavior changes that could occur
                as a result of the implementation of the 30-day unit of service under
                section 1895(b)(2)(B) of the Act and case-mix adjustment factors
                established under section 1895(b)(4)(B) of the Act. Section
                1895(b)(3)(A)(iv) of the Act further requires the Secretary to provide
                a description of the behavior assumptions made in notice and comment
                rulemaking. CMS finalized these behavior assumptions in the CY 2019 HH
                PPS final rule with comment period (83 FR 56461).
                 Section 51001(a)(2)(B) of the BBA of 2018 also added a new
                subparagraph (D) to section 1895(b)(3) of the Act. Section
                1895(b)(3)(D)(i) of the Act requires the Secretary to annually
                determine the impact of differences between assumed behavior changes as
                described in section 1895(b)(3)(A)(iv) of the Act, and actual behavior
                changes on estimated aggregate expenditures under the HH PPS with
                respect to years beginning with 2020 and ending with 2026. Section
                1895(b)(3)(D)(ii) of the Act requires the Secretary, at a time and in a
                manner determined appropriate, through notice and comment rulemaking,
                to provide for one or more permanent increases or decreases to the
                standard prospective payment amount (or amounts) for applicable years,
                on a prospective basis, to offset for such increases or decreases in
                estimated aggregate expenditures, as determined under section
                1895(b)(3)(D)(i) of the Act. Additionally, 1895(b)(3)(D)(iii) of the
                Act requires the Secretary, at a time and in a manner determined
                appropriate, through notice and comment rulemaking, to provide for one
                or more temporary increases or decreases, based on retrospective
                behavior, to the payment amount for a unit of home health services for
                applicable years, on a prospective basis, to offset for such increases
                or decreases in estimated aggregate expenditures, as determined under
                section 1895(b)(3)(D)(i) of the Act. Such a temporary increase or
                decrease shall apply only with respect to the year for which such
                temporary increase or decrease is made, and the Secretary shall not
                take into account such a temporary increase or decrease in computing
                the payment amount for a unit of home health services for a subsequent
                year. And finally, section 51001(a)(3) of the BBA of 2018 amends
                section 1895(b)(4)(B) of the Act by adding a new clause (ii) to require
                the Secretary to eliminate the use of therapy thresholds in the case-
                mix system for CY 2020 and subsequent years.
                2. Current System for Payment of Home Health Services Beginning in CY
                2020 and Subsequent Year
                 For home health periods of care beginning on or after January 1,
                2020, Medicare makes payment under the HH PPS on the basis of a
                national, standardized 30-day period payment rate that is adjusted for
                the applicable case-mix and wage index in accordance with section 51001
                (a)(1)(B) of the BBA of 2018. The national, standardized 30-day period
                rate includes the six home health disciplines (skilled nursing, home
                health aide, physical therapy, speech-language pathology,
                [[Page 39412]]
                occupational therapy, and medical social services). Payment for non-
                routine supplies (NRS) is now part of the national, standardized 30-day
                period rate. Durable medical equipment provided as a home health
                service as defined in section 1861(m) of the Act is paid the fee
                schedule amount and is not included in the national, standardized 30-
                day period payment amount.
                 To better align payment with patient care needs and better ensure
                that clinically complex and ill beneficiaries have adequate access to
                home health care, in the CY 2019 HH PPS final rule with comment period
                (83 FR 56406), we finalized case-mix methodology refinements through
                the Patient-Driven Groupings Model (PDGM) for home health periods of
                care beginning on or after January 1, 2020. To adjust for case-mix for
                30-day periods of care beginning on and after January 1, 2020, the HH
                PPS uses a 432-category case mix classification system to assign
                patients to a home health resource group (HHRG) using patient
                characteristics and other clinical information from Medicare claims and
                the Outcome and Assessment Information Set (OASIS) assessment
                instrument. These 432 HHRGs represent the different payment groups
                based on five main case-mix variables under the PDGM, as shown in
                Figure 1, and subsequently described in more detail throughout this
                section. Each HHRG has an associated case-mix weight which is used in
                calculating the payment for a 30-day period of care. For periods of
                care with visits less than the low-utilization payment adjustment
                (LUPA) threshold for each HHRG, Medicare pays national per-visit rates
                based on the discipline(s) providing the services. Medicare also
                adjusts the national standardized 30-day period payment rate for
                certain intervening events that are subject to a partial payment
                adjustment (PEP adjustment). For certain cases that exceed a specific
                cost threshold, an outlier adjustment may also be available.
                 Under this new case-mix methodology, case-mix weights are generated
                for each of the different PDGM payment groups by regressing resource
                use for each of the five categories listed in this section of this
                proposed rule (admission source, timing clinical grouping, functional
                impairment level, and comorbidity adjustment) using a fixed effects
                model. Below is a description of each of the case-mix variables under
                the PDGM.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.089
                [[Page 39413]]
                a. Timing
                 Thirty-day periods of care are classified as ``early'' or ``late''
                depending on when they occur within a sequence of 30-day periods. The
                first 30-day period of care is classified as early and all subsequent
                30-day periods of care in the sequence (second or later) are classified
                as late. A 30-day period is not be considered early unless there is a
                gap of more than 60 days between the end of one period of care and the
                start of another. Information regarding the timing of a 30-day period
                of care comes from Medicare home health claims data and not the OASIS
                assessment to determine if a 30-day period of care is ``early'' or
                ``late''. While the PDGM case-mix adjustment is applied to each 30-day
                period of care, other home health requirements continue on a 60-day
                basis. Specifically, certifications and re-certifications continue on a
                60-day basis and the comprehensive assessment must still be completed
                within 5 days of the start of care date and completed no less
                frequently than during the last 5 days of every 60 days beginning with
                the start of care date, as currently required by Sec. 484.55,
                ``Condition of participation: Comprehensive assessment of patients.''
                b. Admission Source
                 Each 30-day period of care is classified into one of two admission
                source categories--community or institutional--depending on what
                healthcare setting was utilized in the 14 days prior to home health.
                Thirty-day periods of care for beneficiaries with any inpatient acute
                care hospitalizations, inpatient psychiatric facility (IPF) stays,
                skilled nursing facility (SNF) stays, inpatient rehabilitation facility
                (IRF) stays, or long-term care hospital (LTCH) stays within 14-days
                prior to a home health admission are designated as institutional
                admissions.
                 The institutional admission source category also includes patients
                that had an acute care hospital stay during a previous 30-day period of
                care and within 14 days prior to the subsequent, contiguous 30-day
                period of care and for which the patient was not discharged from home
                health and readmitted (that is, the ``admission date'' and ``from
                date'' for the subsequent 30-day period of care do not match), as we
                acknowledge that HHAs have discretion as to whether they discharge the
                patient due to a hospitalization and then readmit the patient after
                hospital discharge. However, we do not categorize post-acute care
                stays, meaning SNF, IRF, LTCH, or IPF stays, that occur during a
                previous 30-day period of care and within 14 days of a subsequent,
                contiguous 30-day period of care as institutional (that is, the
                ``admission date'' and ``from date'' for the subsequent 30-day period
                of care do not match), as HHAs should discharge the patient if the
                patient required post-acute care in a different setting, or inpatient
                psychiatric care, and then readmit the patient, if necessary, after
                discharge from such setting. All other 30-day periods of care would be
                designated as community admissions.
                 Information from the Medicare claims processing system determines
                the appropriate admission source for final claim payment. The OASIS
                assessment is not utilized in evaluating for admission source
                information. Obtaining this information from the Medicare claims
                processing system, rather than as reported on the OASIS, is a more
                accurate way to determine admission source information as HHAs may be
                unaware of an acute or post-acute care stay prior to home health
                admission. While HHAs can report an occurrence code on submitted claims
                to indicate the admission source, obtaining this information from the
                Medicare claims processing system allows CMS the opportunity and
                flexibility to verify the source of the admission and correct any
                improper payments as deemed appropriate. When the Medicare claims
                processing system receives a Medicare home health claim, the systems
                check for the presence of a Medicare acute or post-acute care claim for
                an institutional stay. If such an institutional claim is found, and the
                institutional claim occurred within 14 days of the home health
                admission, our systems trigger an automatic adjustment to the
                corresponding HH claim to the appropriate institutional category.
                Similarly, when the Medicare claims processing system receives a
                Medicare acute or post-acute care claim for an institutional stay, the
                systems will check for the presence of a HH claim with a community
                admission source payment group. If such HH claim is found, and the
                institutional stay occurred within 14 days prior to the home health
                admission, our systems trigger an automatic adjustment of the HH claim
                to the appropriate institutional category. This process may occur any
                time within the 12-month timely filing period for the acute or post-
                acute claim. For purposes of a Request for Anticipated Payment (RAP),
                only the final claim will be adjusted to reflect the admission source.
                More information regarding the admission source reporting requirements
                for RAP and claims submission, including the use of admission source
                occurrence codes, can be found in the Medicare Claims Processing
                Manual, chapter 10.\2\
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                 \2\ Medicare Claims Processing Manual Chapter 10--Home Health
                Agency Billing. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c10.pdf.
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                c. Clinical Groupings
                 Each 30-day period of care is grouped into one of 12 clinical
                groups which describe the primary reason for which patients are
                receiving home health services under the Medicare home health benefit.
                The clinical grouping is based on the principal diagnosis reported on
                home health claims. The 12 clinical groups are listed and described in
                Table 2.
                [[Page 39414]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.090
                 If a home health claim is submitted with a principal diagnosis that
                is not assigned to a clinical group (for example, because the diagnosis
                code is vague, ill-defined, unspecified, or is subject to certain ICD-
                10-CM coding conventions), the claim is returned to the provider for
                more definitive coding. While these clinical groups represent the
                primary reason for home health services during a 30-day period of care,
                this does not mean that they represent the only reason for home health
                services. Home health remains a multidisciplinary benefit and payment
                is bundled to cover all necessary home health services identified on
                the individualized home health plan of care. Therefore, regardless of
                the clinical group assignment, HHAs are required, in accordance with
                the home health CoPs at Sec. 484.60(a)(2), to ensure that the
                individualized home health plan of care addresses all care needs,
                including the disciplines to provide such care. Under the PDGM, the
                clinical group is just one variable in the overall case-mix adjustment
                for a home health period of care. Moreover, it is possible for the
                principal diagnosis to change between the first and second 30-day
                period of care and the claim for the second 30-day period of care would
                reflect the new principal diagnosis. HHAs would not change the claim
                for the first 30-day period.
                d. Functional Impairment Level
                 Each 30-day period of care will be placed into one of three
                functional impairment levels, low, medium, or high, based on responses
                to certain OASIS functional items associated with grooming, bathing,
                dressing, ambulating, transferring, and risk for hospitalization. The
                specific OASIS items that are used for the functional impairment level
                are found in Table 7 in the CY 2020 HH PPS final rule with comment
                period (84 FR 60478, 60490). Responses to these OASIS items are grouped
                together into response categories with similar resource use and each
                response category has associated points. A more detailed description as
                to how these response categories were established can be found in the
                technical report, ``Overview of the Home Health Groupings Model''
                posted on the HHA web page.\3\ The sum of these points' results in a
                functional impairment level score used to group 30-day periods of care
                into a functional impairment level with similar resource use. The
                scores associated with the functional impairment levels vary by
                clinical group to account for differences in resource utilization. The
                functional impairment level will remain the same for the first and
                second 30-day periods of care unless there has been a significant
                change in condition which warranted an ``other follow-up'' assessment
                prior to the second 30-day period of care. For each 30-day period of
                care, the Medicare claims processing system will look for the most
                recent
                [[Page 39415]]
                OASIS assessment based on the claims ``from date.''
                ---------------------------------------------------------------------------
                 \3\ Overview of the Home Health Groupings Model. November 18,
                2016. https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
                ---------------------------------------------------------------------------
                e. Comorbidity Adjustment
                 Thirty-day periods will receive a comorbidity adjustment category
                based on the presence of certain secondary diagnoses reported on home
                health claims. These diagnoses are based on a home-health specific list
                of clinically and statistically significant secondary diagnosis
                subgroups with similar resource use, meaning the secondary diagnoses
                have at least as high as the median resource use and represent more
                that 0.1 percent of 30-day periods of care. Home health 30-day periods
                of care can receive a comorbidity adjustment under the following
                circumstances:
                 Low comorbidity adjustment: There is a reported
                secondary diagnosis on the home health-specific comorbidity subgroup
                list that is associated with higher resource use.
                 High comorbidity adjustment: There are two or
                more secondary diagnoses on the home health-specific comorbidity
                subgroup interaction list that are associated with higher resource use
                when both are reported together compared to if they were reported
                separately. That is, the two diagnoses may interact with one another,
                resulting in higher resource use.
                 No comorbidity adjustment: A 30-day period of
                care will receive no comorbidity adjustment if no secondary diagnoses
                exist or none meet the criteria for a low or high comorbidity
                adjustment. A 30-day period of care can have a low comorbidity
                adjustment or a high comorbidity adjustment, but not both. A 30-day
                period of care can receive only one low comorbidity adjustment
                regardless of the number of secondary diagnoses reported on the home
                health claim that fell into one of the individual comorbidity subgroups
                or one high comorbidity adjustment regardless of the number of
                comorbidity group interactions, as applicable. The low comorbidity
                adjustment amount will be the same across the subgroups and the high
                comorbidity adjustment will be the same across the subgroup
                interactions.
                B. Proposed Provisions for Payment Under the Home Health Prospective
                Payment System (HH PPS)
                1. CY 2021 PDGM Low-Utilization Payment Adjustment (LUPA) Thresholds
                and PDGM Case-Mix Weights
                a. Proposed CY 2021 PDGM LUPA Thresholds
                 Under the HH PPS, low utilization payment adjustments (LUPAs) are
                paid when a certain visit threshold for a payment group during a 30-day
                period of care is not met. The approach to calculating the LUPA
                thresholds under the PDGM changed to account for the 30-day unit of
                payment. Therefore, in order to target the same percentage of LUPA
                periods as under the previous 153-group case-mix system (that is,
                approximately 7-8 percent of 30-day periods would be LUPAs), in the CY
                2019 HH PPS final rule (83 FR 56492) we finalized that the LUPA
                thresholds would be set at the 10th percentile of visits or 2 visits,
                whichever is higher, for each payment group. This means that the LUPA
                threshold for each 30-day period of care varies depending on the PDGM
                payment group to which it is assigned. If the LUPA threshold for the
                payment group is met under the PDGM, the 30-day period of care will be
                paid the full 30-day period case-mix adjusted payment amount. If a 30-
                day period of care does not meet the PDGM LUPA visit threshold, then
                payment will be made using the CY 2021 per-visit payment amounts as
                described in section III.C.3.c. of this proposed rule. For example, if
                the LUPA visit threshold is four, and a 30-day period of care has four
                or more visits, it is paid the full 30-day period payment amount; if
                the period of care has three or less visits, payment is made using the
                per-visit payment amounts.
                 In the CY 2019 HH PPS final rule with comment period (83 FR 56492),
                we finalized our policy that the LUPA thresholds for each PDGM payment
                group would be reevaluated every year based on the most current
                utilization data available at the time of rulemaking. However, CY 2020
                was the first year of the new case-mix adjustment methodology and 30-
                day unit of payment and at this time we do not have sufficient CY 2020
                data in which to make any changes to the LUPA thresholds for CY 2021.
                We believe that making any changes to the LUPA thresholds for CY 2021
                based off of 2019 utilization using the 153-group model would result in
                little change in the LUPA thresholds from CY 2020 to CY 2021 and would
                result in additional burden to HHAs and software vendors in revising
                their internal billing software to reflect only minor changes.
                Therefore, we are proposing to maintain the LUPA thresholds finalized
                and shown in Table 16 of the CY 2020 HH PPS final rule with comment
                period (84 FR 60522) for CY 2021 payment purposes. We will repost these
                LUPA thresholds (along with the case-mix weights) that will be used for
                CY 2021 on the HHA Center and PDGM web pages.
                b. CY 2021 PDGM Case-Mix Weights
                 As finalized in the CY 2019 HH PPS final rule with comment period
                (83 FR 56502), the PDGM places patients into meaningful payment
                categories based on patient and other characteristics, such as timing,
                admission source, clinical grouping using the reported principal
                diagnosis, functional impairment level, and comorbid conditions. The
                PDGM case-mix methodology results in 432 unique case-mix groups called
                HHRGs. We also finalized in the CY 2019 HH PPS final rule with comment
                period (83 FR 56515) to annually recalibrate the PDGM case-mix weights
                using a fixed effects model using the most recent, complete utilization
                data available at the time of annual rulemaking. However, as noted
                previously, we do not have sufficient CY 2020 data from the first year
                of the new case-mix methodology and because the 2019 data utilize the
                old 153-case-mix methodology and 60-day episodes of payment such data
                are not appropriate for use to simulate 30-day periods under the PDGM
                in order to recalibrate the case-mix weights for CY 2021. Therefore, we
                are proposing to maintain the PDGM case-mix weights finalized and shown
                in Table 16 of the CY 2020 HH PPS final rule with comment period (84 FR
                60522) for CY 2021 payment purposes.
                 We will repost the case-mix weights proposed for CY 2021 on the HHA
                Center and PDGM web pages. As mentioned previously in this section, we
                believe this approach for CY 2021 is more accurate given the limited
                utilization data for CY 2020 and will be less burdensome for HHAs and
                software vendors, who continue to familiarize themselves with this new
                case-mix methodology.
                2. Proposed Home Health Wage Index Changes
                a. Proposed Implementation of New Labor Market Delineations
                 Generally, OMB issues major revisions to statistical areas every 10
                years, based on the results of the decennial census. However, OMB
                [[Page 39416]]
                occasionally issues minor updates and revisions to statistical areas in
                the years between the decennial censuses. On April 10, 2018 OMB issued
                OMB Bulletin No. 18-03 which superseded the August 15, 2017 OMB
                Bulletin No. 17-01. On September 14, 2018, OMB issued, OMB Bulletin No.
                18-04, which superseded the April 10, 2018 OMB Bulletin No. 18-03.
                These bulletins established revisions to the delineation of MSAs,
                Micropolitan Statistical Areas, and Combines Statistical Areas, and
                guidance on uses of the delineation in these areas. A copy of the
                September 2018 bulletin is available at: https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf. We note that on March 6,
                2020 OMB issued OMB Bulletin No. 20-01 (available at https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf. As
                discussed below, this bulletin was not available in time for the
                development of this proposed rule. Bulletin No. 18-04 states it
                ``provides the delineations of all Metropolitan Statistical Areas,
                Metropolitan Divisions, Micropolitan Statistical Areas, Combined
                Statistical Areas, and New England City and Town Areas in the United
                States and Puerto Rico based on the standards published in the June 28,
                2010, Federal Register (75 FR 37246 through 37252), and Census Bureau
                data.''
                 While the revisions OMB published on September 14, 2018, are not as
                sweeping as the changes made when we adopted the CBSA geographic
                designations for CY 2006, the September 14, 2018 bulletin does contain
                a number of significant changes. For example, there are new CBSAs,
                urban counties that have become rural, rural counties that have become
                urban, and existing CBSAs that have been split apart. We believe it is
                important for the home health wage index to use the latest OMB
                delineations available in order to maintain a more accurate and up-to-
                date payment system that reflects the reality of population shifts and
                labor market conditions. We further believe that using the September
                2018 OMB delineations would increase the integrity of the HH PPS wage
                index by creating a more accurate representation of geographic
                variation in wage levels. We have reviewed our findings and impacts
                relating to the new OMB delineations, and have concluded that there is
                no compelling reason to further delay implementation. We are proposing
                to implement the new OMB delineations as described in the September 14,
                2018 OMB Bulletin No. 18-04 for the home health wage index effective
                beginning in CY 2021. As noted previously, the March 6, 2020 OMB
                Bulletin No. 20-01 was not available in time for development of this
                proposed rule. We will include any updates from OMB Bulletin No. 20-01
                in any changes that would be adopted in the CY 2022 HH PPS proposed
                rule.
                (1) Micropolitan Statistical Areas
                 As discussed in the CY 2006 HH PPS proposed rule (70 FR 40788) and
                final rule (70 FR 68132), CMS considered how to use the Micropolitan
                statistical area definitions in the calculation of the wage index. OMB
                defines a ``Micropolitan Statistical Area'' as a ``CBSA'' associated
                with at least one urban cluster that has a population of at least
                10,000, but less than 50,000 (75 FR 37252). We refer to these as
                Micropolitan Areas. After extensive impact analysis, consistent with
                the treatment of these areas under the IPPS as discussed in the FY 2005
                IPPS final rule (69 FR 49029 through 49032), we determined the best
                course of action would be to treat Micropolitan Areas as ``rural'' and
                include them in the calculation of each state's home health rural wage
                index (see 70 FR 40788 and 70 FR 68132). Thus, the HH PPS statewide
                rural wage index is determined using IPPS hospital data from hospitals
                located in non-Metropolitan Statistical Areas (MSA).
                 Based upon the 2010 Decennial Census data, a number of urban
                counties have switched status and have joined or became Micropolitan
                Areas, and some counties that once were part of a Micropolitan Area,
                have become urban. Overall, there are fewer Micropolitan Areas (542)
                under the new OMB delineations based on the 2010 Census than existed
                under the latest data from the 2000 Census (581). We believe that the
                best course of action would be to continue the policy established in
                the CY 2006 HH PPS final rule and include Micropolitan Areas in each
                state's rural wage index. These areas continue to be defined as having
                relatively small urban cores (populations of 10,000 to 49,999).
                Therefore, in conjunction with our proposal to implement the new OMB
                labor market delineations beginning in CY 2021 and consistent with the
                treatment of Micropolitan Areas under the IPPS, we are proposing to
                continue to treat Micropolitan Areas as ``rural'' and to include
                Micropolitan Areas in the calculation of each state's rural wage index.
                (2) Urban Counties Becoming Rural
                 If we adopt the new OMB delineations (based upon the 2010 decennial
                Census data), a total of 34 counties (and county equivalents) that are
                currently considered urban would be considered rural beginning in CY
                2021. Table 3 lists the 34 counties that would change to rural status
                if we finalize our proposal to implement the new OMB delineations.
                BILLING CODE 4120-01-P
                [[Page 39417]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.091
                (3) Rural Counties Becoming Urban
                 If we finalize our proposal to implement the new OMB delineations
                (based upon the 2010 decennial Census data), a total of 47 counties
                (and county equivalents) that are currently designated rural would be
                considered urban beginning in CY 2021. Table 4 lists the 47 counties
                that would change to urban status.
                [[Page 39418]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.092
                [[Page 39419]]
                (4) Urban Counties Moving to a Different Urban CBSA
                 In addition to rural counties becoming urban and urban counties
                becoming rural, several urban counties would shift from one urban CBSA
                to another urban CBSA under our proposal to adopt the new OMB
                delineations (Table 5). In other cases, applying the new OMB
                delineations would involve a change only in CBSA name or number, while
                the CBSA continues to encompass the same constituent counties. For
                example, CBSA 19380 (Dayton, OH) would experience both a change to its
                number and its name, and become CBSA 19430 (Dayton-Kettering, OH),
                while all of its three constituent counties would remain the same. In
                other cases, only the name of the CBSA would be modified, and none of
                the currently assigned counties would be reassigned to a different
                urban CBSA. We are not discussing these proposed changes in this
                section because they are inconsequential changes with respect to the
                home health wage index.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.093
                 However, in other cases, if we adopt the new OMB delineations,
                counties would shift between existing and new CBSAs, changing the
                constituent makeup of the CBSAs. In another type of change, some CBSAs
                have counties that would split off to become part of or to form
                entirely new labor market areas. Finally, in some cases, a CBSA would
                lose counties to another existing CBSA if we adopt the new OMB
                delineations. Table 6 lists the urban counties that would move from one
                urban CBSA to a newly or modified CBSA if we adopt the new OMB
                delineations.
                [[Page 39420]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.094
                BILLING CODE 4120-01-C
                b. Proposed Transition Period
                 As discussed above, overall, we believe that our proposal to adopt
                the revised OMB delineations for CY 2021 would result in HH PPS wage
                index values being more representative of the actual costs of labor in
                a given area. However, we also recognize that some home health agencies
                would experience decreases in their area wage index values as a result
                of our proposal. We also realize that many home health agencies would
                have higher area wage index values under our proposal.
                 To mitigate the potential impacts of proposed policies on home
                health agencies, we have in the past provided for transition periods
                when adopting changes that have significant payment implications,
                particularly large negative impacts. For example, we have proposed and
                finalized budget neutral transition policies to help mitigate negative
                impacts on home health agencies following the adoption of the new CBSA
                delineations based on the 2010 decennial census data in the CY 2015
                home health final rule (79 FR 66032). Specifically, we implemented a 1-
                year 50/50 blended wage to the new OMB delineations. We applied a
                blended wage index for 1 year (CY 2015) for all geographic areas that
                would consist of a 50/50 blend of the wage index values using OMB's old
                area delineations and the wage index values using OMB's new area
                delineations. That is, for each county, a blended wage index was
                calculated equal to 50 percent of the CY 2015 wage index using the old
                labor market area delineation and 50 percent of the CY 2015 wage index
                using the new labor market area delineation, which resulted in an
                average of the two values. While we believed that using the new OMB
                delineations would create a more accurate payment adjustment for
                differences in area wage levels, we also recognized that adopting such
                changes may cause some short-term instability in home health payments.
                Similar instability may result from the proposed wage policies herein,
                in particular for home health agencies that would be negatively
                impacted by the proposed adoption of the updates to the OMB
                delineations. We are proposing a transition policy to help mitigate any
                significant negative impacts that home health agencies may experience
                due to our proposal to adopt the revised OMB delineations.
                 Specifically, for CY 2021 as a transition, we are proposing to
                apply a 5 percent cap on any decrease in a geographic area's wage index
                value from the wage index value from the prior calendar year. This
                transition would allow the effects of our proposed adoption of the
                revised CBSA delineations to be phased in over 2 years, where the
                estimated reduction in a geographic area's wage index would be capped
                at 5 percent in CY 2021 (that is, no cap would be applied to the
                reduction in the wage index for the second year (CY 2022)). We believe
                a 5 percent cap on the overall decrease in a geographic area's wage
                index value, regardless of the circumstance causing the decline, would
                be appropriate transition for CY 2021 as it provides predictability in
                payment levels from CY 2020 to the upcoming CY 2021 and additional
                transparency because it is administratively simpler than our prior 1-
                year 50/50 blended wage index approach. Consistent with the policy
                finalized under the IPPS and proposed in other Medicare settings, we
                believe 5 percent is a reasonable level for the cap because it would
                effectively mitigate any significant decreases in a geographic area's
                wage index value for CY 2021 that could result from the
                [[Page 39421]]
                adoption of the new OMB delineations. We believe a one year 5 percent
                cap provides home health agencies sufficient time to plan appropriately
                for CY 2022 and future years. Because we believe that using the new OMB
                delineations would create a more accurate payment adjustment for
                differences in area wage levels we are proposing to include a cap on
                the overall decrease in a geographic area's wage index value.
                 While there are some minimal impacts on certain HHAs as a result of
                this 5 percent cap proposal as shown in the regulatory impact analysis
                of this proposed rule, overall, the impact between the CY 2021 wage
                index using the old OMB delineations and the proposed CY 2021 wage
                index using the new OMB delineations would be 0.0 percent due to the
                wage index budget neutrality factor, which ensures that wage index
                updates and revisions are implemented in a budget-neutral manner. We
                invite comments on our proposed transition methodology.
                 The proposed wage index applicable to CY 2021 can be found on the
                CMS website at https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center. The proposed HH PPS wage index for CY 2021 would be
                effective January 1, 2021 through December 31, 2021.
                 The wage index file posted on the CMS website provides a crosswalk
                between the CY 2021 wage index using the current OMB delineations and
                the CY 2021 wage index using the proposed revised OMB delineations, as
                well as the proposed transition wage index values that would be in
                effect in CY 2021 if these proposed changes are finalized. It also
                shows each state and county and its corresponding proposed transition
                wage index along with the previous CBSA number, the new CBSA number or
                alternate identification number, and the new CBSA name.
                3. Proposed CY 2021 Home Health Payment Rate Updates
                a. Proposed CY 2021 Home Health Market Basket Update for HHAs
                 Section 1895(b)(3)(B) of the Act requires that the standard
                prospective payment amounts for CY 2021 be increased by a factor equal
                to the applicable home health market basket update for those HHAs that
                submit quality data as required by the Secretary. In the CY 2019 HH PPS
                final rule with comment period (83 FR 56425), we finalized a rebasing
                of the home health market basket to reflect 2016 Medicare cost report
                (MCR) data, the latest available and complete data on the actual
                structure of HHA costs. As such, based on the rebased 2016-based home
                health market basket, we finalized that the labor-related share is 76.1
                percent and the non-labor-related share is 23.9 percent. A detailed
                description of how we rebased the HHA market basket is available in the
                CY 2019 HH PPS final rule with comment period (83 FR 56425 through
                56436).
                 Section 1895(b)(3)(B) of the Act requires that in CY 2015 and in
                subsequent calendar years, except CY 2018 (under section 411(c) of the
                Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L.
                114-10, enacted April 16, 2015)), and CY 2020 (under section 53110 of
                the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted
                February 9, 2018)), the market basket percentage under the HHA
                prospective payment system, as described in section 1895(b)(3)(B) of
                the Act, be annually adjusted by changes in economy-wide productivity.
                Section 1886(b)(3)(B)(xi)(II) of the Act defines the productivity
                adjustment to be equal to the 10-year moving average of change in
                annual economy-wide private nonfarm business multifactor productivity
                (MFP) (as projected by the Secretary for the 10-year period ending with
                the applicable fiscal year, calendar year, cost reporting period, or
                other annual period) (the ``MFP adjustment''). The Bureau of Labor
                Statistics (BLS) is the agency that publishes the official measure of
                private nonfarm business MFP. Please visit http://www.bls.gov/mfp, to
                obtain the BLS historical published MFP data.
                 The proposed home health update percentage for CY 2021 is based on
                the estimated home health market basket update, specified at section
                1895(b)(3)(B)(iii) of the Act, of 3.1 percent (based on IHS Global
                Insight Inc.'s first-quarter 2020 forecast with historical data through
                fourth-quarter 2019). The estimated CY 2021 home health market basket
                update of 3.1 percent is then reduced by a MFP adjustment, as mandated
                by the section 3401 of the Patient Protection and Affordable Care Act
                (the Affordable Care Act) (Pub. L. 111-148), currently estimated to be
                0.4 percentage point for CY 2021. In effect, the proposed home health
                payment update percentage for CY 2021 is a 2.7 percent increase.
                Section 1895(b)(3)(B)(v) of the Act requires that the home health
                update be decreased by 2 percentage points for those HHAs that do not
                submit quality data as required by the Secretary. For HHAs that do not
                submit the required quality data for CY 2021, the home health payment
                update would be 0.7 percent (2.7 percent minus 2 percentage points). If
                more recent data becomes available after the publication of this
                proposed rule and before the publication of the final rule (for
                example, more recent estimates of the home health market basket update
                and MFP adjustment), we would use such data, if appropriate, to
                determine the home health payment update percentage for CY 2021 in the
                final rule.
                b. CY 2021 Home Health Wage Index
                 Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the
                Secretary to provide appropriate adjustments to the proportion of the
                payment amount under the HH PPS that account for area wage differences,
                using adjustment factors that reflect the relative level of wages and
                wage-related costs applicable to the furnishing of HH services. Since
                the inception of the HH PPS, we have used inpatient hospital wage data
                in developing a wage index to be applied to HH payments. We propose to
                continue this practice for CY 2021, as we continue to believe that, in
                the absence of HH-specific wage data that accounts for area
                differences, using inpatient hospital wage data is appropriate and
                reasonable for the HH PPS. As discussed above, we propose to use the FY
                2021 pre-floor, pre-reclassified hospital wage index with the September
                2018 OMB delineations as the CY 2021 wage adjustment to the labor
                portion of the HH PPS rates. For CY 2021, the updated wage data are for
                hospital cost reporting periods beginning on or after October 1, 2016,
                and before October 1, 2017 (FY 2017 cost report data). We apply the
                appropriate wage index value to the labor portion of the HH PPS rates
                based on the site of service for the beneficiary (defined by section
                1861(m) of the Act as the beneficiary's place of residence).
                 To address those geographic areas in which there are no inpatient
                hospitals, and thus, no hospital wage data on which to base the
                calculation of the CY 2021 HH PPS wage index, we propose to continue to
                use the same methodology discussed in the CY 2007 HH PPS final rule (71
                FR 65884) to address those geographic areas in which there are no
                inpatient hospitals. For rural areas that do not have inpatient
                hospitals, we propose to use the average wage index from all contiguous
                Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently,
                the only rural area without a hospital from which hospital wage data
                could be derived is Puerto Rico. However, for rural Puerto Rico, we do
                not apply this methodology due to the distinct economic circumstances
                that exist there (for
                [[Page 39422]]
                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 propose to continue to use the
                most recent wage index previously available for that area. The most
                recent wage index previously available for rural Puerto Rico is 0.4047.
                For urban areas without inpatient hospitals, we use the average wage
                index of all urban areas within the state as a reasonable proxy for the
                wage index for that CBSA. For CY 2021, the only urban area without
                inpatient hospital wage data is Hinesville, GA (CBSA 25980). The CY
                2021 adjusted, new delineations wage index value for Hinesville, GA is
                0.8478.
                 On February 28, 2013, OMB issued Bulletin No. 13-01, announcing
                revisions to the delineations of MSAs, Micropolitan Statistical Areas,
                and CBSAs, and guidance on uses of the delineation of these areas. In
                the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we adopted
                OMB's area delineations using a 1-year transition.
                 On August 15, 2017, OMB issued Bulletin No. 17-01 in which it
                announced that one Micropolitan Statistical Area, Twin Falls, Idaho,
                now qualifies as a Metropolitan Statistical Area. The new CBSA (46300)
                comprises the principal city of Twin Falls, Idaho in Jerome County,
                Idaho and Twin Falls County, Idaho. The CY 2021 HH PPS wage index value
                for CBSA 46300, Twin Falls, Idaho, will be 0.8586. Bulletin No. 17-01
                is available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.\4\
                ---------------------------------------------------------------------------
                 \4\ ``Revised Delineations of Metropolitan Statistical Areas,
                Micropolitan Statistical Areas, and Combined Statistical Areas, and
                Guidance on Uses of the Delineations of These Areas''. OMB Bulletin
                No. 17-01. August 15, 2017. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
                ---------------------------------------------------------------------------
                 On April 10, 2018 OMB issued OMB Bulletin No. 18-03 which
                superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14,
                2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 10,
                2018 OMB Bulletin No. 18-03. These bulletins established revised
                delineations for Metropolitan Statistical Areas, Micropolitan
                Statistical Areas, and Combined Statistical Areas, and provided
                guidance on the use of the delineations of these statistical areas. A
                copy of OMB Bulletin No. 18-04 may be obtained at https://www.whitehouse.gov/wpcontent/uploads/2018/09/Bulletin-18-04.pdf.
                 As discussed previously the most recent OMB Bulletin (No. 20-01)
                was published on March 6, 2020 and is available at https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.
                 The proposed CY 2021 wage index is available on the CMS website at:
                https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
                c. CY 2021 Annual Payment Update
                (1) Background
                 The Medicare HH PPS has been in effect since October 1, 2000. As
                set forth in the July 3, 2000 final rule (65 FR 41128), the base unit
                of payment under the Medicare HH PPS was a national, standardized 60-
                day episode payment rate. As finalized in the CY 2019 HH PPS final rule
                with comment period (83 FR 56406), and as described in the CY 2020 HH
                PPS final rule with comment period (84 FR 60478), the unit of home
                health payment changed from a 60-day episode to a 30-day period
                effective for those 30-day periods beginning on or after January 11,
                2020.
                As set forth in Sec. 484.220, we adjust the national, standardized
                prospective payment rates by a case-mix relative weight and a wage
                index value based on the site of service for the beneficiary. To
                provide appropriate adjustments to the proportion of the payment amount
                under the HH PPS to account for area wage differences, we apply the
                appropriate wage index value to the labor portion of the HH PPS rates.
                In the CY 2019 HH PPS final rule with comment period (83 FR 56435), we
                finalized rebasing the home health market basket to reflect 2016
                Medicare cost report (MCR) data, the latest available and most complete
                data on the actual structure of HHA costs. We also finalized a revision
                to the labor-related share to reflect the 2016-based home health market
                basket compensation (Wages and Salaries plus Benefits) cost weight. We
                finalized that for CY 2019 and subsequent years, the labor-related
                share would be 76.1 percent and the non-labor-related share would be
                23.9 percent. The following are the steps we take to compute the case-
                mix and wage-adjusted 30-day period rates for CY 2021:
                 Multiply the national, standardized 30-day period rate by
                the patient's applicable case-mix weight.
                 Divide the case-mix adjusted amount into a labor (76.1
                percent) and a non-labor portion (23.9 percent).
                 Multiply the labor portion by the applicable wage index
                based on the site of service of the beneficiary.
                 Add the wage-adjusted portion to the non-labor portion,
                yielding the case-mix and wage adjusted 30-day period rate, subject to
                any additional applicable adjustments.
                 We provide annual updates of the HH PPS rate in accordance with
                section 1895(b)(3)(B) of the Act. Section 484.225 sets forth the
                specific annual percentage update methodology. In accordance with
                section 1895(b)(3)(B)(v) of the Act and Sec. 484.225(i), for an HHA
                that does not submit HH quality data, as specified by the Secretary,
                the unadjusted national prospective 30-day period rate is equal to the
                rate for the previous calendar year increased by the applicable HH
                payment update, minus 2 percentage points. Any reduction of the
                percentage change would apply only to the calendar year involved and
                would not be considered in computing the prospective payment amount for
                a subsequent calendar year.
                 The final claim that the HHA submits for payment determines the
                total payment amount for the period and whether we make an applicable
                adjustment to the 30-day case-mix and wage-adjusted payment amount. The
                end date of the 30-day period, as reported on the claim, determines
                which calendar year rates Medicare will use to pay the claim.
                 We may adjust a 30-day case-mix and wage-adjusted payment based on
                the information submitted on the claim to reflect the following:
                 A low-utilization payment adjustment (LUPA) is provided on
                a per-visit basis as set forth in Sec. Sec. 484.205(d)(1) and 484.230.
                 A partial payment adjustment as set forth in Sec. Sec.
                484.205(d)(2) and 484.235.
                 An outlier payment as set forth in Sec. Sec.
                484.205(d)(3) and 484.240.
                (2) CY 2021 National, Standardized 30-Day Period Payment Amount
                 Section 1895(b)(3)(D)(i) of the Act, as added by section
                51001(a)(2)(B) of the BBA of 2018, requires us to analyze data for CYs
                2020 through 2026, after implementation of the 30-day unit of payment
                and new PDGM case-mix adjustment methodology, to annually determine the
                impact of the differences between assumed behavior changes and actual
                behavior changes on estimated aggregate expenditures. While we continue
                to monitor the impact of these changes on patient outcomes and Medicare
                expenditures, we believe it would be premature to release any
                information related to these issues based on the amount of data
                currently available and in light of the current public health emergency
                resulting from the COVID-19 pandemic outbreak. Therefore, for CY 2021,
                we are not proposing to make any additional
                [[Page 39423]]
                changes to the national, standardized 30-day payment rate in this
                proposed rule other than the routine rate updates outlined below. In
                future rulemaking, we plan to determine whether any changes need to be
                made to the national, standardized 30-day payment rate based on the
                analysis of the actual versus assumed behavior change.
                 Section 1895(b)(3)(A)(i) of the Act requires that the standard
                prospective payment rate and other applicable amounts be standardized
                in a manner that eliminates the effects of variations in relative case-
                mix and area wage adjustments among different home health agencies in a
                budget-neutral manner. To determine the CY 2021 national, standardized
                30-day period payment rate, we apply a wage index budget neutrality
                factor and the home health payment update percentage discussed in
                section III.C.2. of this proposed rule.
                 To calculate the wage index budget neutrality factor, we simulated
                total payments for non-LUPA 30-day periods using the proposed CY 2021
                wage index and compared it to our simulation of total payments for non-
                LUPA 30-day periods using the CY 2020 wage index. By dividing the total
                payments for non-LUPA 30-day periods using the CY 2021 wage index by
                the total payments for non-LUPA 30-day periods using the CY 2020 wage
                index, we obtain a wage index budget neutrality factor of 0.9987. We
                would apply the wage index budget neutrality factor of 0.9987 to the
                calculation of the CY 2021 national, standardized 30-day period payment
                rate.
                 We note that in past years, a case-mix budget neutrality factor was
                annually applied to the HH PPS base rates to account for the change
                between the previous year's case-mix weights and the newly recalibrated
                case-mix weights. Since CY 2020 was the first year of PDGM, we are not
                proposing to recalibrate the PDGM case-mix weights and; therefore, a
                case-mix budget neutrality factor is not needed. However, in future
                years under the PDGM, we would apply a case-mix budget neutrality
                factor with the annual payment update in order to account for the
                change between the previous year's PDGM case-mix weights and the new
                recalibrated PDGM case-mix weights.
                 Next, we would update the 30-day payment rate by the CY 2021 home
                health payment update percentage of 2.7 percent. The CY 2021 national,
                standardized 30-day period payment rate is calculated in Table 7.
                BILLING CODE 4120-01-P
                [GRAPHIC] [TIFF OMITTED] TP30JN20.095
                 The CY 2021 national, standardized 30-day episode payment rate for
                an HHA that does not submit the required quality data is updated by the
                CY 2021 home health payment update of 2.7 percent minus 2 percentage
                points and is shown in Table 8.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.096
                (3) CY 2021 National Per-Visit Rates for 30-Day Periods of Care
                 The national per-visit rates are used to pay LUPAs and are also
                used to compute imputed costs in outlier calculations. The per-visit
                rates are paid by type of visit or HH discipline. The six HH
                disciplines are as follows:
                 Home health aide (HH aide).
                 Medical Social Services (MSS).
                 Occupational therapy (OT).
                 Physical therapy (PT).
                 Skilled nursing (SN).
                 Speech-language pathology (SLP).
                 To calculate the CY 2021 national per-visit rates, we started with
                the CY 2020 national per-visit rates. Then we applied a wage index
                budget neutrality factor to ensure budget neutrality for LUPA per-visit
                payments. We calculated the wage index budget neutrality factor by
                simulating total payments for LUPA 30-day periods of care using the CY
                2021 wage index and comparing it to simulated total payments for LUPA
                30-day periods using the CY 2020 wage index. By dividing the total
                payments for LUPA 30-day periods using the CY 2021 wage index by the
                total payments for LUPA 30-day periods using the CY 2020 wage index, we
                obtained a wage index budget neutrality factor of 0.9985. We apply the
                wage index budget neutrality factor in order to calculate the CY 2021
                national per-visit rates.
                [[Page 39424]]
                 The LUPA per-visit rates are not calculated using case-mix weights.
                Therefore, no case-mix weights budget neutrality factor is needed to
                ensure budget neutrality for LUPA payments. Lastly, the per-visit rates
                for each discipline are updated by the CY 2021 home health payment
                update percentage of 2.7 percent. The national per-visit rates are
                adjusted by the wage index based on the site of service of the
                beneficiary. The per-visit payments for LUPAs are separate from the
                LUPA add-on payment amount, which is paid for episodes that occur as
                the only episode or initial episode in a sequence of adjacent episodes.
                The CY 2021 national per-visit rates for HHAs that submit the required
                quality data are updated by the CY 2021 HH payment update percentage of
                2.7 percent and are shown in Table 9.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.097
                 The CY 2021 per-visit payment rates for HHAs that do not submit the
                required quality data are updated by the CY 2020 HH payment update
                percentage of 2.7 percent minus 2 percentage points and are shown in
                Table 10.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.098
                BILLING CODE 4120-01-C
                 We are reminding stakeholders of the policies finalized in the CY
                2020 HH PPS final rule with comment (84 FR 60544) with regards to the
                submission of Requests for Anticipated payment (RAPs) for CY 2021 and
                the implementation of a new one-time Notice of Admission (NOA) process
                starting in CY 2022. In that final rule, we finalized the lowering of
                the up-front payment made in response to a RAP to zero percent for all
                30-day periods of care beginning on or after January 1, 2021 (84 FR
                60544). For CY 2021, all HHAs (both existing and newly-enrolled HHAs)
                will submit a RAP at the beginning of each 30-day period establish the
                home health period of care in the common working file and also to
                trigger the consolidated billing edits. With the removal of the upfront
                RAP payment for CY 2021, we relaxed the required information for
                submitting the RAP for CY 2021 and also stated that the information
                required for submitting an NOA for CYs 2022 and beyond would mirror
                that of the RAP in CY 2021. Starting in CY 2022, HHAs will submit a
                one-time NOA that establishes the home health period of care and covers
                all contiguous 30-day periods of care until the individual is
                discharged from Medicare home health services. Also, for both the
                submission of the RAP in CY 2021 and the one-time NOA for CYs 2022 and
                beyond, we finalized a payment reduction if the HHA does not submit the
                RAP for CY 2021 or NOA for CYs 2022 and beyond within 5 calendar days
                from the start of care. That is, if an HHA fails to submit a timely RAP
                for CY 2021 or fails to submit a timely NOA for CYs 2022 and beyond,
                the reduction in payment amount would be equal to a one-thirtieth
                reduction to the wage and case-mix adjusted 30-day period payment
                amount for each day from the home health start of care date until the
                [[Page 39425]]
                date the HHA submitted the RAP or NOA. In other words, the one-
                thirtieth reduction would be to the 30-day period adjusted payment
                amount, including any outlier payment, that the HHA otherwise would
                have received absent any reduction. For LUPA 30-day periods of care in
                which an HHA fails to submit a timely RAP or NOA, no LUPA payments
                would be made for days that fall within the period of care prior to the
                submission of the RAP or NOA. We stated that these days would be a
                provider liability, the payment reduction could not exceed the total
                payment of the claim, and that the provider may not bill the
                beneficiary for these days. For more in-depth information regarding the
                finalized policies associated with RAPs and the new one-time NOA
                process, we refer readers to the CY 2020 HH PPS final rule with comment
                (84 FR 60544).
                (4) Low-Utilization Payment Adjustment (LUPA) Add-On Factors
                 Prior to the implementation of the 30-day unit of payment, LUPA
                episodes were eligible for a LUPA add-on payment if the episode of care
                was the first or only episode in a sequence of adjacent episodes. As
                stated in the CY 2008 HH PPS final rule, we stated that the average
                visit lengths in these initial LUPAs are 16 to 18 percent higher than
                the average visit lengths in initial non-LUPA episodes (72 FR 49848).
                LUPA episodes that occur as the only episode or as an initial episode
                in a sequence of adjacent episodes are adjusted by applying an
                additional amount to the LUPA payment before adjusting for area wage
                differences. In the CY 2014 HH PPS final rule (78 FR 72305), we changed
                the methodology for calculating the LUPA add-on amount by finalizing
                the use of three LUPA add-on factors: 1.8451 for SN; 1.6700 for PT; and
                1.6266 for SLP. We multiply the per-visit payment amount for the first
                SN, PT, or SLP visit in LUPA episodes that occur as the only episode or
                an initial episode in a sequence of adjacent episodes by the
                appropriate factor to determine the LUPA add-on payment amount.
                 In the CY 2019 HH PPS final rule with comment period (83 FR 56440),
                in addition to finalizing a 30-day unit of payment, we finalized our
                policy of continuing to multiply the per-visit payment amount for the
                first skilled nursing, physical therapy, or speech-language pathology
                visit in LUPA periods that occur as the only period of care or the
                initial 30-day period of care in a sequence of adjacent 30-day periods
                of care by the appropriate add-on factor (1.8451 for SN, 1.6700 for PT,
                and 1.6266 for SLP) to determine the LUPA add-on payment amount for 30-
                day periods of care under the PDGM. For example, using the proposed CY
                2021 per-visit payment rates for those HHAs that submit the required
                quality data, for LUPA periods that occur as the only period or an
                initial period in a sequence of adjacent periods, if the first skilled
                visit is SN, the payment for that visit would be $283.30 (1.8451
                multiplied by $153.54), subject to area wage adjustment.
                d. Rural Add-On Payments for CY 2021 and CY 2022
                (1) Background
                 Section 421(a) of the Medicare Prescription Drug Improvement and
                Modernization Act of 2003 (MMA) (Pub. L. 108-173) required, for HH
                services furnished in a rural area (as defined in section 1886(d)(2)(D)
                of the Act), for episodes or visits ending on or after April 1, 2004,
                and before April 1, 2005, that the Secretary increase the payment
                amount that otherwise would have been made under section 1895 of the
                Act for the services by 5 percent. Section 5201 of the Deficit
                Reduction Act of 2003 (DRA) (Pub. L. 108-171) amended section 421(a) of
                the MMA. The amended section 421(a) of the MMA required, for HH
                services furnished in a rural area (as defined in section 1886(d)(2)(D)
                of the Act), on or after January 1, 2006, and before January 1, 2007,
                that the Secretary increase the payment amount otherwise made under
                section 1895 of the Act for those services by 5 percent.
                 Section 3131(c) of the Affordable Care Act amended section 421(a)
                of the MMA to provide an increase of 3 percent of the payment amount
                otherwise made under section 1895 of the Act for HH services furnished
                in a rural area (as defined in section 1886(d)(2)(D) of the Act), for
                episodes and visits ending on or after April 1, 2010, and before
                January 1, 2016. Section 210 of the MACRA amended section 421(a) of the
                MMA to extend the rural add-on by providing an increase of 3 percent of
                the payment amount otherwise made under section 1895 of the Act for HH
                services provided in a rural area (as defined in section 1886(d)(2)(D)
                of the Act), for episodes and visits ending before January 1, 2018.
                 Section 50208(a) of the BBA of 2018 amended section 421(a) of the
                MMA to extend the rural add-on by providing an increase of 3 percent of
                the payment amount otherwise made under section 1895 of the Act for HH
                services provided in a rural area (as defined in section 1886(d)(2)(D)
                of the Act), for episodes and visits ending before January 1, 2019.
                (2) Rural Add-On Payments for CYs 2019 Through CY 2022
                 Section 50208(a)(1)(D) of the BBA of 2018 added a new subsection
                (b) to section 421 of the MMA to provide rural add-on payments for
                episodes or visits ending during CYs 2019 through 2022. It also
                mandated implementation of a new methodology for applying those
                payments. Unlike previous rural add-ons, which were applied to all
                rural areas uniformly, the extension provided varying add-on amounts
                depending on the rural county (or equivalent area) classification by
                classifying each rural county (or equivalent area) into one of three
                distinct categories: (1) Rural counties and equivalent areas in the
                highest quartile of all counties and equivalent areas based on the
                number of Medicare home health episodes furnished per 100 individuals
                who are entitled to, or enrolled for, benefits under Part A of Medicare
                or enrolled for benefits under Part B of Medicare only, but not
                enrolled in a Medicare Advantage plan under Part C of Medicare (the
                ``High utilization'' category); (2) rural counties and equivalent areas
                with a population density of 6 individuals or fewer per square mile of
                land area and are not included in the ``High utilization'' category
                (the ``Low population density'' category); and (3) rural counties and
                equivalent areas not in either the ``High utilization'' or ``Low
                population density'' categories (the ``All other'' category).
                 In the CY 2019 HH PPS final rule with comment period (83 FR 56443),
                CMS finalized policies for the rural add-on payments for CY 2019
                through CY 2022, in accordance with section 50208 of the BBA of 2018.
                The CY 2019 HH PPS proposed rule (83 FR 32373) described the provisions
                of the rural add-on payments, the methodology for applying the new
                payments, and outlined how we categorized rural counties (or equivalent
                areas) based on claims data, the Medicare Beneficiary Summary File and
                Census data. The data used to categorize each county or equivalent area
                is available in the Downloads section associated with the publication
                of this rule at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. In addition, an Excel file containing the
                rural county or equivalent area name, their Federal Information
                Processing Standards (FIPS) state and county codes, and their
                designation into one of
                [[Page 39426]]
                the three rural add-on categories is available for download.
                 The HH PRICER module, located within CMS' claims processing system,
                will increase the CY 2021 30-day base payment rates, described in
                section III.C.3.b. of this proposed rule, by the appropriate rural add-
                on percentage prior to applying any case-mix and wage index
                adjustments. The CY 2019 through CY 2022 rural add-on percentages
                outlined in law are shown in Table 11.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.099
                e. Proposed Payments for High-Cost Outliers Under the HH PPS
                (1) Background
                 Section 1895(b)(5) of the Act allows for the provision of an
                addition or adjustment to the home health payment amount otherwise made
                in the case of outliers because of unusual variations in the type or
                amount of medically necessary care. Under the HH PPS, outlier payments
                are made for episodes whose estimated costs exceed a threshold amount
                for each Home Health Resource Group (HHRG). The episode's estimated
                cost was established as the sum of the national wage-adjusted per visit
                payment amounts delivered during the episode. The outlier threshold for
                each case-mix group or partial episode payment (PEP) adjustment is
                defined as the 60-day episode payment or PEP adjustment for that group
                plus a fixed-dollar loss (FDL) amount. For the purposes of the HH PPS,
                the FDL amount is calculated by multiplying the HH FDL ratio by a
                case's wage-adjusted national, standardized 60-day episode payment
                rate, which yields an FDL dollar amount for the case. The outlier
                threshold amount is the sum of the wage and case-mix adjusted PPS
                episode amount and wage-adjusted FDL amount. The outlier payment is
                defined to be a proportion of the wage-adjusted estimated cost that
                surpasses the wage-adjusted threshold. The proportion of additional
                costs over the outlier threshold amount paid as outlier payments is
                referred to as the loss-sharing ratio.
                 As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through
                70399), section 3131(b)(1) of the Affordable Care Act amended section
                1895(b)(3)(C) of the Act to require that the Secretary reduce the HH
                PPS payment rates such that aggregate HH PPS payments were reduced by 5
                percent. In addition, section 3131(b)(2) of the Affordable Care Act
                amended section 1895(b)(5) of the Act by redesignating the existing
                language as section 1895(b)(5)(A) of the Act and revising the language
                to state that the total amount of the additional payments or payment
                adjustments for outlier episodes could not exceed 2.5 percent of the
                estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of
                the Affordable Care Act also added section 1895(b)(5)(B) of the Act,
                which capped outlier payments as a percent of total payments for each
                HHA for each year at 10 percent.
                 As such, beginning in CY 2011, we reduced payment rates by 5
                percent and targeted up to 2.5 percent of total estimated HH PPS
                payments to be paid as outliers. To do so, we first returned the 2.5
                percent held for the target CY 2010 outlier pool to the national,
                standardized 60-day episode rates, the national per visit rates, the
                LUPA add-on payment amount, and the NRS conversion factor for CY 2010.
                We then reduced the rates by 5 percent as required by section
                1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the
                Affordable Care Act. For CY 2011 and subsequent calendar years we
                targeted up to 2.5 percent of estimated total payments to be paid as
                outlier payments, and apply a 10-percent agency-level outlier cap.
                 In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through
                43742 and 81 FR 76702), we described our concerns regarding patterns
                observed in home health outlier episodes. Specifically, we noted that
                the methodology for calculating home health outlier payments may have
                created a financial incentive for providers to increase the number of
                visits during an episode of care in order to surpass the outlier
                threshold; and simultaneously created a disincentive for providers to
                treat medically complex beneficiaries who require fewer but longer
                visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR
                76702), we finalized changes to the methodology used to calculate
                outlier payments, using a cost-per-unit approach rather than a cost-
                per-visit approach. This change in methodology allows for more accurate
                payment for outlier episodes, accounting for both the number of visits
                during an episode of care and also the length of the visits provided.
                Using this approach, we now convert the national per-visit rates into
                per 15-minute unit rates. These per 15-minute unit rates are used to
                calculate the estimated cost of an episode to determine whether the
                claim will receive an outlier payment and the amount of payment for an
                episode of care. In conjunction with our finalized policy to change to
                a cost-per-unit approach to estimate episode costs and determine
                whether an outlier episode should receive outlier payments, in the CY
                2017 HH PPS final rule we also finalized the implementation of a cap on
                the amount of time per day that would be counted toward the estimation
                of an episode's costs for outlier calculation purposes (81 FR 76725).
                Specifically, we limit the amount of time per day (summed across the
                six disciplines of care) to 8 hours (32 units) per day when estimating
                the cost of an episode for outlier calculation purposes.
                 We will publish the cost-per-unit amounts for CY 2021 in the rate
                update change request, which is issued after the publication of the CY
                2021 HH PPS final rule. We note that in the CY 2017 HH PPS final rule
                (81 FR 76724), we stated that we did not plan to re-estimate the
                average minutes per visit by discipline every year. Additionally, we
                noted that the per unit rates used to estimate an episode's cost will
                be updated by the home health update percentage each year, meaning we
                would start with the national per visit amounts for the same calendar
                year when calculating the cost-per-unit used to determine the cost of
                an episode of care (81 FR 76727). We note that we will continue to
                monitor the visit length by discipline as more recent data become
                available, and we may
                [[Page 39427]]
                propose to update the rates as needed in the future.
                 In the CY 2019 HH PPS final rule with comment period (83 FR 56521),
                we finalized a policy to maintain the current methodology for payment
                of high-cost outliers upon implementation of the PDGM beginning in CY
                2020 and that we will calculate payment for high-cost outliers based
                upon 30-day periods of care.
                (2) Fixed Dollar Loss (FDL) Ratio for CY 2021
                 For a given level of outlier payments, there is a trade-off between
                the values selected for the FDL ratio and the loss-sharing ratio. A
                high FDL ratio reduces the number of periods that can receive outlier
                payments, but makes it possible to select a higher loss-sharing ratio,
                and therefore, increase outlier payments for qualifying outlier
                periods. Alternatively, a lower FDL ratio means that more periods can
                qualify for outlier payments, but outlier payments per period must then
                be lower.
                 The FDL ratio and the loss-sharing ratio must be selected so that
                the estimated total outlier payments do not exceed the 2.5 percent
                aggregate level (as required by section 1895(b)(5)(A) of the Act).
                Historically, we have used a value of 0.80 for the loss-sharing ratio
                which, we believe, preserves incentives for agencies to attempt to
                provide care efficiently for outlier cases. With a loss-sharing ratio
                of 0.80, Medicare pays 80 percent of the additional estimated costs
                that exceed the outlier threshold amount. Given the statutory
                requirement that total outlier payments not exceed 2.5 percent of the
                total payments estimated to be made under the HH PPS, we finalized that
                the FDL ratio for 30-day periods of care in CY 2020 would need to be
                set at 0.63 for 30-day periods of care based on our simulations looking
                at both 60-day episodes that would span into CY 2020 and 30-day periods
                that begin in CY 2020. Given that CY 2020 is the first year of the PDGM
                and the change to a 30-day unit of payment, for CY 2021, we are
                proposing to maintain the fixed-dollar loss ratio of 0.63, as finalized
                for CY 2020.
                4. The Use of Technology Under the Medicare Home Health Benefit
                 In the first COVID-19 PHE IFC (85 FR 19230), we changed the plan of
                care requirements at Sec. 409.43(a) on an interim basis, for the
                purposes of Medicare payment, to state that the plan of care must
                include any provision of remote patient monitoring or other services
                furnished via a telecommunications system and describe how the use of
                such technology is tied to the patient-specific needs as identified in
                the comprehensive assessment and will help to achieve the goals
                outlined on the plan of care. The amended plan of care requirements at
                Sec. 409.43(a) also state that these services cannot substitute for a
                home visit ordered as part of the plan of care and cannot be considered
                a home visit for the purposes of patient eligibility or payment, in
                accordance with section 1895(e)(1)(A) of the Act. In the first COVID-19
                PHE IFC, we stated that we believe that this change will help to
                increase access to technologies, such as telemedicine and remote
                patient monitoring during the public health emergency for the COVID-19
                pandemic (85 FR 19250).
                 Additionally, the Coronavirus Aid, Relief, and Economic Security
                Act (CARES Act) (Pub. L. 116-136) included section 3707 related to
                encouraging use of telecommunications systems for home health services
                furnished during the emergency period. Specifically, section 3707 of
                the CARES Act requires, with respect to home health services furnished
                during the PHE for COVID-19, that the Secretary shall consider ways to
                encourage the use of telecommunications systems, including for remote
                patient monitoring as described in Sec. 409.46(e) and other
                communications or monitoring services, consistent with the plan of care
                for the individual, including by clarifying guidance and conducting
                outreach, as appropriate. We believe that the policies finalized on an
                interim basis meet the requirements of section 3707 of the CARES Act.
                 We have also heard from stakeholders about the important role that
                technologies can play in the delivery of appropriate home health
                services outside of the current pandemic. In the first COVID-19 PHE IFC
                (85 FR 19230), we discussed the various applications of the technology
                that HHAs and industry representatives have reported utilizing prior to
                taking the steps necessary in meeting the social distancing required
                during the public health emergency for the COVID-19 pandemic. Although
                section 1895(e)(1)(A) of the Act prohibits payment for services
                furnished via a telecommunications system if such services substitute
                for in-person home health services ordered as part of a plan of care,
                we understand that there are ways in which technology can be further
                utilized to improve patient care, better leverage advanced practice
                clinicians, and improve outcomes while potentially making the provision
                of home health care more efficient. We acknowledged that technology has
                become an integral part of medicine across the entire spectrum of
                healthcare, and that telemedicine, in particular has the potential to
                play a large role in enhancing the delivery of healthcare in the home.
                In the first COVID-19 PHE IFC, we included the following illustrative
                example of in-person visits and the use of telecommunications
                technology:
                 A patient recently discharged from the hospital after coronary
                bypass surgery was receiving home health skilled nursing visits 3 times
                a week for medication management, teaching and assessment. The patient
                developed a fever, cough, sore throat and moderate shortness of breath
                and now has a confirmed COVID-19 diagnosis, which the doctor has
                determined can be safely managed at home with home health services. The
                patient has been prescribed new medications for symptom management and
                oxygen therapy to support the patient's respiratory status. The
                patient's home health plan of care was updated to include an in-person
                skilled nursing visit once a week to assess the patient and to monitor
                for worsening symptoms. The plan of care was updated also to include a
                video consultation twice a week between the skilled nurse and the
                patient for medication management, teaching and assessment, as well as
                to obtain oxygen saturation readings that the patient relays to the
                nurse during the consultation.
                 With regards to payment under the HH PPS, if the primary reason for
                home health care is to provide care to manage the symptoms resulting
                from COVID-19, this 30-day period of care would be grouped into the
                Medication, Management, Teaching and Assessment (MMTA)-Respiratory
                clinical group, and it would be an early 30-day period of care with an
                institutional admission source. Assuming a medium functional impairment
                level with ``low'' comorbidities, the low-utilization payment
                adjustment (LUPA) threshold would be 4 visits. Regardless if the
                patient continued to receive the original 3 in-person skilled nursing
                visits per week (12 visits total in the 30-day period) rather than the
                once per-week in-person skilled nursing visits (4 visits total in the
                30-day period), the HHA would still receive the full 30-day payment
                amount (rather than paying per visit if the total number of visits was
                below the LUPA threshold). In this example, the use of technology is
                not a substitute for the provision of in-person visits as ordered on
                the plan of care, as the plan of care was updated to reflect a change
                in the frequency of the in-
                [[Page 39428]]
                person visits and to include ``virtual visits'' using
                telecommunications technology as part of the management of the home
                health patient. We believe the provision of in-person visits and
                encounters using telecommunications technology can also apply outside
                of the public health emergency. Decisions regarding the use of
                telecommunications technology would be determined based on patient
                needs identified during the comprehensive assessment and would be
                included as part of the individualized plan of care established and
                reviewed by the physician who establishes the plan of care.
                 For these reasons, we are proposing to permanently finalize the
                amendment to Sec. 409.43(a) as outlined in the first COVID-19 PHE IFC
                (85 FR 19230). We are also proposing to allow HHAs to continue to
                report the costs of telehealth/telemedicine as allowable administrative
                costs on line 5 of the home health agency cost report. We propose to
                modify the instructions regarding this line on the cost report to
                reflect a broader use of telecommunications technology. Additionally,
                we propose to amend Sec. 409.46(e) to include not only remote patient
                monitoring, but other communications or monitoring services, consistent
                with the plan of care for the individual. Because stakeholders have
                identified significant up-front costs in incorporating and evaluating
                various forms of telecommunications systems into home health care, this
                would allow HHAs to confidently plan for the continued inclusion of
                telecommunications systems under the Medicare home health benefit and
                increase the tools available to promote patient involvement and
                autonomy and potentially more efficient home health care.
                 We remind stakeholders that access to telecommunications technology
                must be inclusive, especially for those patients who may have
                disabilities where the use of technology may be more challenging.
                Section 504 of the Rehabilitation Act and the Americans with
                Disabilities Act protect qualified individuals with disabilities from
                discrimination on the basis of disability in the provision of benefits
                and services. Concerns related to potential discrimination issues under
                504 should be referred to the Office of Civil Rights for further
                review. Likewise, we remind HHAs that the home health CoPs at Sec.
                484.50(f)(1) require that information must be provided to persons with
                disabilities in plain language and in a manner that is accessible and
                timely, including accessible websites and the provision of auxiliary
                aids and services at no cost to the individual in accordance with the
                Americans with Disabilities Act and section 504 of the Rehabilitation
                Act. This means that the HHA must meet these requirements to ensure
                access to and use of telecommunications as required by law. Appendix B
                of the State Operations Manual (regarding Home Health services)
                provides detailed examples of ``auxiliary aids and services''.\5\
                ---------------------------------------------------------------------------
                 \5\ State Operations Manual Appendix B--Guidance to Surveyors:
                Home Health Agencies. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_b_hha.pdf.
                ---------------------------------------------------------------------------
                 We also reiterate the expectation that services provided by
                telecommunications technology are services that could also be provided
                through an in-person visit. If there is a service that cannot be
                provided through telecommunications technology (for example, wound care
                which requires in-person, hands-on care), the HHA must make an in-
                person visit to furnish such services. Furthermore, a HHA cannot
                discriminate against any individual who is unable or unwilling to
                receive home health services that could be provided via
                telecommunications technology. In those circumstances, the HHA must
                provide such services through in-person visits as the intent of the
                Medicare home health benefit as defined in section 1861(m) of the Act
                is to provide items and services on a visiting basis in the
                individual's home.
                 We solicit comments on our proposal to finalize the amendment to
                Sec. 409.43(a) as outlined in the first COVID-19 PHE IFC (85 FR 19230)
                to allow the use of telecommunications technology included as part of
                the home health plan of care as long as the use of such technology does
                not substitute for ordered in-person visits. We also solicit comments
                on our proposal to amend the language at Sec. 409.46(e) allowing a
                broader use of telecommunications technology to be reported as an
                allowable administrative cost on the home health agency cost report.
                IV. Other Home Health Related Provisions
                A. Home Health Quality Reporting Program (HH QRP)
                1. Background and Statutory Authority
                 The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act.
                Section 1895(b)(3)(B)(v)(II) of the Act requires that, for 2007 and
                subsequent years, each HHA submit to the Secretary in a form and
                manner, and at a time, specified by the Secretary, such data that the
                Secretary determines are appropriate for the measurement of health care
                quality. To the extent that an HHA does not submit data in accordance
                with this clause, the Secretary shall reduce the home health market
                basket percentage increase applicable to the HHA for such year by 2
                percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act,
                depending on the market basket percentage increase applicable for a
                particular year, the reduction of that increase by 2 percentage points
                for failure to comply with the requirements of the HH QRP and further
                reduction of the increase by the productivity adjustment (except in
                2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act
                may result in the home health market basket percentage increase being
                less than 0.0 percent for a year, and may result in payment rates under
                the Home Health PPS for a year being less than payment rates for the
                preceding year.
                 For more information on the policies we have adopted for the HH
                QRP, we refer readers to the following rules:
                 CY 2007 HH PPS final rule (71 FR 65888 through 65891).
                 CY 2008 HH PPS final rule (72 FR 49861 through 49864).
                 CY 2009 HH PPS update notice (73 FR 65356).
                 CY 2010 HH PPS final rule (74 FR 58096 through 58098).
                 CY 2011 HH PPS final rule (75 FR 70400 through 70407).
                 CY 2012 HH PPS final rule (76 FR 68574).
                 CY 2013 HH PPS final rule (77 FR 67092).
                 CY 2014 HH PPS final rule (78 FR 72297).
                 CY 2015 HH PPS final rule (79 FR 66073 through 66074).
                 CY 2016 HH PPS final rule (80 FR 68690 through 68695).
                 CY 2017 HH PPS final rule (81 FR 76752).
                 CY 2018 HH PPS final rule (82 FR 51711 through 51712).
                 CY 2019 HH PPS final rule with comment period (83 FR
                56547).
                 CY 2020 HH PPS final rule with comment period (84 FR
                60554).
                2. General Considerations Used for the Selection of Quality Measures
                for the HH QRP
                [[Page 39429]]
                 For a detailed discussion of the considerations we historically use
                for measure selection for the HH QRP quality, resource use, and others
                measures, we refer readers to the CY 2016 HH PPS final rule (80 FR
                68695 through 68696). In the CY 2019 HH PPS final rule with comment (83
                FR 56548 through 56550) we also finalized the factors we consider for
                removing previously adopted HH QRP measures.
                3. Quality Measures Currently Adopted for the CY 2022 HH QRP
                 The HH QRP currently includes 20 measures for the CY 2022 program
                year, as outlined in Table 28 of the CY 2020 HH PPS final rule (84 FR
                60555).\6\
                ---------------------------------------------------------------------------
                 \6\ The HHCAHPS has five component questions that together are
                used to represent one NQF-endorsed measure.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.100
                [[Page 39430]]
                 There are no proposals or updates in this proposed rule for the
                Home Health Quality Reporting Program.
                B. Proposed Change to the Conditions of Participation (CoPs) OASIS
                Requirements
                 Section 484.45(c)(2) of the home health agency conditions of
                participation (CoPs) requires that new home health agencies must
                successfully transmit test data to the Quality Improvement & Evaluation
                System (QIES) or CMS OASIS contractor as part of the initial process
                for becoming a Medicare-participating home health agency. The previous
                data submission system limited HHAs to only 2 users who had permission
                to access the system, and required the use of a virtual private network
                (VPN) to access CMSNet. New HHAs do not yet have a CMS Certification
                Number (CCN). Therefore, they used a fake or test CCN in order to
                transmit test data to the Quality Improvement & Evaluation System
                Assessment Submission & Processing (QIES ASAP) System or CMS OASIS
                contractor.
                 CMS recently enhanced the system that HHAs use to submit OASIS data
                to be more user friendly. The new CMS data submission system, internet
                Quality Improvement & Evaluation System (iQIES), is now internet-based.
                Therefore, HHAs are no longer limited to 2 users for submission of
                assessment data since VPN and CMSNet are no longer required. These
                factors make the data submission process simpler. In addition, the new
                iQIES data submission system requires users to include a valid CCN with
                their iQIES user role request that will allow them to submit their
                OASIS assessment data to CMS; the new data system no longer supports
                the use of test or fake CCNs, making it impossible for new HHAs that do
                not yet have a CCN to submit test data.
                 The transition to the new data submission system, the simpler data
                submission process and the inability to use test or fake CCNs has
                rendered the requirement at Sec. 484.45(c)(2) obsolete. Therefore, we
                are proposing to remove the requirement at Sec. 484.45(c)(2). HHAs
                must be able to submit assessments in order for the claims match
                process to occur and relay the data needed for payment under the PDGM
                system. This link to the payment process gives HHAs strong incentive to
                ensure that they can successfully submit their OASIS assessments in the
                absence of this regulatory requirement.
                V. Home Infusion Therapy
                A. Medicare Coverage of Home Infusion Therapy Services
                1. Background and Overview
                a. Background
                 Section 5012 of the 21st Century Cures Act (``the Cures Act'')
                (Pub. L. 114-255), which amended sections 1834(u), 1861(s)(2) and
                1861(iii) of the Act, established a new Medicare home infusion therapy
                services benefit. The Medicare home infusion therapy services benefit
                covers the professional services, including nursing services, furnished
                in accordance with the plan of care, patient training and education not
                otherwise covered under the durable medical equipment benefit, remote
                monitoring, and monitoring services for the provision of home infusion
                therapy and home infusion drugs furnished by a qualified home infusion
                therapy supplier. This benefit will ensure consistency in coverage for
                home infusion benefits for all Medicare beneficiaries.
                 Section 50401 of the Bipartisan Budget Act (BBA) of 2018 amended
                section 1834(u) of the Act by adding a new paragraph (7) that
                established a home infusion therapy services temporary transitional
                payment for eligible home infusion suppliers for certain items and
                services furnished in coordination with the furnishing of transitional
                home infusion drugs beginning January 1, 2019. This temporary payment
                covers the cost of the same items and services, as defined in section
                1861(iii)(2)(A) and (B) of the Act, related to the administration of
                home infusion drugs. The temporary transitional payment began on
                January 1, 2019 and will end the day before the full implementation of
                the home infusion therapy services benefit on January 1, 2021, as
                required by section 5012 of the 21st Century Cures Act.
                 In the CY 2019 HH PPS final rule with comment period (83 FR 56406),
                we finalized the implementation of temporary transitional payments for
                home infusion therapy services to begin on January 1, 2019. In
                addition, we implemented the establishment of regulatory authority for
                the oversight of national accrediting organizations (AOs) that accredit
                home infusion therapy suppliers, and their CMS-approved home infusion
                therapy accreditation programs.
                b. Overview of Infusion Therapy
                 Infusion drugs can be administered in multiple health care
                settings, including inpatient hospitals, skilled nursing facilities
                (SNFs), hospital outpatient departments (HOPDs), physicians' offices,
                and in the home. Traditional fee-for-service (FFS) Medicare provides
                coverage for infusion drugs, equipment, supplies, and administration
                services. However, Medicare coverage requirements and payment vary for
                each of these settings. Infusion drugs, equipment, supplies, and
                administration are all covered by Medicare in the inpatient hospital,
                SNFs, HOPDs, and physicians' offices.
                 Under the various Part A prospective payment systems, Medicare
                payment for the drugs, equipment, supplies, and services are bundled,
                meaning a single payment is made on the basis of expected costs for
                clinically-defined episodes of care. For example, if a beneficiary is
                receiving an infusion drug during an inpatient hospital stay, the Part
                A payment for the drug, supplies, equipment, and drug administration is
                included in the diagnosis-related group (DRG) payment to the hospital
                under the Medicare inpatient prospective payment system. Beneficiaries
                are liable for the Medicare inpatient hospital deductible and no
                coinsurance for the first 60 days. Similarly, if a beneficiary is
                receiving an infusion drug while in a SNF under a Part A stay, the
                payment for the drug, supplies, equipment, and drug administration are
                included in the SNF prospective payment system payment. After 20 days
                of SNF care, there is a daily beneficiary cost-sharing amount through
                day 100 when the beneficiary becomes responsible for all costs for each
                day after day 100 of the benefit period.
                 Under Medicare Part B, certain items and services are paid
                separately while other items and services may be packaged into a single
                payment together. For example, in an HOPD and in a physician's office,
                the drug is paid separately, generally at the average sales price (ASP)
                plus 6 percent (77 FR 68210). Medicare also makes a separate payment to
                the physician or hospital outpatient departments (HOPD) for
                administering the drug. The separate payment for infusion drug
                administration in an HOPD and in a physician's office generally
                includes a base payment amount for the first hour and a payment add-on
                that is a different amount for each additional hour of administration.
                The beneficiary is responsible for the 20 percent coinsurance under
                Medicare Part B.
                 Medicare FFS covers outpatient infusion drugs under Part B,
                ``incident to'' a physician's service, provided the drugs are not
                usually self-administered by the patient. Drugs that are ``not usually
                self-administered,'' are defined in our manual according to how the
                [[Page 39431]]
                Medicare population as a whole uses the drug, not how an individual
                patient or physician may choose to use a particular drug. For the
                purpose of this exclusion, the term ``usually'' means more than 50
                percent of the time for all Medicare beneficiaries who use the drug.
                The term ``by the patient'' means Medicare beneficiaries as a
                collective whole. Therefore, if a drug is self-administered by more
                than 50 percent of Medicare beneficiaries, the drug is generally
                excluded from Part B coverage. This determination is made on a drug-by-
                drug basis, not on a beneficiary-by-beneficiary basis.\7\ The MACs
                update Self-Administered Drug (SAD) exclusion lists on a quarterly
                basis.\8\
                ---------------------------------------------------------------------------
                 \7\ Medicare Benefit Policy Manual, Chapter 15, ``Covered
                Medical and Other Health Services'', section 50.2--Determining Self-
                Administration of Drug or Biological. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
                 \8\ Self-Administered Drug (SAD) Exclusion List Report.
                www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx?bc=AQAAAAAAAAAAAA%3D%3D.
                ---------------------------------------------------------------------------
                 Home infusion therapy involves the intravenous or subcutaneous
                administration of drugs or biologicals to an individual at home.
                Certain drugs can be infused in the home, but the nature of the home
                setting presents different challenges than the settings previously
                described. Generally, the components needed to perform home infusion
                include the drug (for example, antivirals, immune globulin), equipment
                (for example, a pump), and supplies (for example, tubing and
                catheters). Likewise, nursing services are usually necessary to train
                and educate the patient and caregivers on the safe administration of
                infusion drugs in the home. Visiting nurses often play a large role in
                home infusion. These nurses typically train the patient or caregiver to
                self-administer the drug, educate on side effects and goals of therapy,
                and visit periodically to assess the infusion site and provide dressing
                changes. Depending on patient acuity or the complexity of the drug
                administration, certain infusions may require more training and
                education, especially those that require special handling or pre-or
                post-infusion protocols. The home infusion process typically requires
                coordination among multiple entities, including patients, physicians,
                hospital discharge planners, health plans, home infusion pharmacies,
                and, if applicable, home health agencies.
                 With regard to payment for home infusion therapy under traditional
                Medicare, drugs are generally covered under Part B or Part D. Certain
                infusion pumps, supplies (including home infusion drugs and the
                services required to furnish the drug, (that is, preparation and
                dispensing), and nursing are covered in some circumstances through the
                Part B durable medical equipment (DME) benefit, the Medicare home
                health benefit, or some combination of these benefits. In accordance
                with section 50401 of the BBA of 2018, beginning on January 1, 2019,
                for CYs 2019 and 2020, Medicare implemented temporary transitional
                payments for home infusion therapy services furnished in coordination
                with the furnishing of transitional home infusion drugs. This payment,
                for home infusion therapy services, is only made if a beneficiary is
                furnished certain drugs and biologicals administered through an item of
                covered DME, and payable only to suppliers enrolled in Medicare as
                pharmacies that provide external infusion pumps and external infusion
                pump supplies (including the drug). With regard to the coverage of the
                home infusion drugs, Medicare Part B covers a limited number of home
                infusion drugs through the DME benefit if: (1) The drug is necessary
                for the effective use of an external infusion pump classified as DME
                and determined to be reasonable and necessary for administration of the
                drug; and (2) the drug being used with the pump is itself reasonable
                and necessary for the treatment of an illness or injury.
                 Only certain types of infusion pumps are covered under the DME
                benefit. In order for the infusion pump to be covered under the DME
                benefit, it must be appropriate for use in the home (Sec. 414.202).
                The Medicare National Coverage Determinations Manual, chapter 1, part
                4, section 280.14 describes the types of infusion pumps that are
                covered under the DME benefit.\9\ For DME external infusion pumps,
                Medicare Part B covers the infusion drugs and other supplies and
                services necessary for the effective use of the pump. Through the Local
                Coverage Determination (LCD) for External Infusion Pumps (L33794), the
                DME Medicare administrative contractors (MACs) specify the details of
                which infusion drugs are covered with these pumps. Examples of covered
                Part B DME infusion drugs include, among others, certain IV drugs for
                heart failure and pulmonary arterial hypertension, immune globulin for
                primary immune deficiency (PID), insulin, antifungals, antivirals, and
                chemotherapy, in limited circumstances.
                ---------------------------------------------------------------------------
                 \9\ National Coverage Determinations Manual. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.html.
                ---------------------------------------------------------------------------
                c. Home Infusion Therapy Legislation
                (1) 21st Century Cures Act
                 Effective January 1, 2021, section 5012 of the 21st Century Cures
                Act (Pub. L. 114-255) (Cures Act) created a separate Medicare Part B
                benefit category under section 1861(s)(2)(GG) of the Act for coverage
                of home infusion therapy services needed for the safe and effective
                administration of certain drugs and biologicals administered
                intravenously, or subcutaneously for an administration period of 15
                minutes or more, in the home of an individual, through a pump that is
                an item of DME. The infusion pump and supplies (including home infusion
                drugs) will continue to be covered under the Part B DME benefit.
                Section 1861(iii)(2) of the Act defines home infusion therapy to
                include the following items and services: The professional services,
                including nursing services, furnished in accordance with the plan,
                training and education (not otherwise paid for as DME), remote
                monitoring, and other monitoring services for the provision of home
                infusion therapy and home infusion drugs furnished by a qualified home
                infusion therapy supplier, which are furnished in the individual's
                home. Section 1861(iii)(3)(B) of the Act defines the patient's home to
                mean a place of residence used as the home of an individual as defined
                for purposes of section 1861(n) of the Act. As outlined in section
                1861(iii)(1) of the Act, to be eligible to receive home infusion
                therapy services under the home infusion therapy services benefit, the
                patient must be under the care of an applicable provider (defined in
                section 1861(iii)(3)(A) of the Act as a physician, nurse practitioner,
                or physician's assistant), and the patient must be under a physician-
                established plan of care that prescribes the type, amount, and duration
                of infusion therapy services that are to be furnished. The plan of care
                must be periodically reviewed by the physician in coordination with the
                furnishing of home infusion drugs (as defined in section
                1861(iii)(3)(C) of the Act). Section 1861(iii)(3)(C) of the Act defines
                a ``home infusion drug'' under the home infusion therapy services
                benefit as a drug or biological administered intravenously, or
                subcutaneously for an administration period of 15 minutes or more, in
                the patient's home, through a pump that is an item of DME as defined
                under section 1861(n) of the Act. This definition does not include
                insulin pump systems or any self-administered
                [[Page 39432]]
                drug or biological on a self-administered drug exclusion list.
                 Section 1861(iii)(3)(D)(i) of the Act defines a ``qualified home
                infusion therapy supplier'' as a pharmacy, physician, or other provider
                of services or supplier licensed by the state in which supplies or
                services are furnished. The provision specifies that qualified home
                infusion therapy suppliers must furnish infusion therapy to individuals
                with acute or chronic conditions requiring administration of home
                infusion drugs; ensure the safe and effective provision and
                administration of home infusion therapy on a 7-day-a-week, 24-hour-a-
                day basis; be accredited by an organization designated by the
                Secretary; and meet other such requirements as the Secretary deems
                appropriate, taking into account the standards of care for home
                infusion therapy established by Medicare Advantage (MA) plans under
                Part C and in the private sector. The supplier may subcontract with a
                pharmacy, physician, other qualified supplier or provider of medical
                services, in order to meet these requirements.
                 Section 1834(u)(1) of the Act requires the Secretary to implement a
                payment system under which, beginning January 1, 2021, a single payment
                is made to a qualified home infusion therapy supplier for the items and
                services (professional services, including nursing services; training
                and education; remote monitoring, and other monitoring services). The
                single payment must take into account, as appropriate, types of
                infusion therapy, including variations in utilization of services by
                therapy type. In addition, the single payment amount is required to be
                adjusted to reflect geographic wage index and other costs that may vary
                by region, patient acuity, and complexity of drug administration. The
                single payment may be adjusted to reflect outlier situations, and other
                factors as deemed appropriate by the Secretary, which are required to
                be done in a budget-neutral manner. Section 1834(u)(2) of the Act
                specifies certain items that ``the Secretary may consider'' in
                developing the home infusion therapy payment system: ``the costs of
                furnishing infusion therapy in the home, consult[ation] with home
                infusion therapy suppliers, . . . payment amounts for similar items and
                services under this part and Part A, and . . . payment amounts
                established by Medicare Advantage plans under Part C and in the private
                insurance market for home infusion therapy (including average per
                treatment day payment amounts by type of home infusion therapy)''.
                Section 1834(u)(3) of the Act specifies that annual updates to the
                single payment are required to be made, beginning January 1, 2022, by
                increasing the single payment amount by the percent increase in the
                Consumer Price Index for all urban consumers (CPI-U) for the 12-month
                period ending with June of the preceding year, reduced by the 10-year
                moving average of changes in annual economy-wide private nonfarm
                business multifactor productivity (MFP). Under section
                1834(u)(1)(A)(iii) of the Act, the single payment amount for each
                infusion drug administration calendar day, including the required
                adjustments and the annual update, cannot exceed the amount determined
                under the fee schedule under section 1848 of the Act for infusion
                therapy services if furnished in a physician's office. This statutory
                provision limits the single payment amount so that it cannot reflect
                more than 5 hours of infusion for a particular therapy per calendar
                day. Section 1834(u)(4) of the Act also allows the Secretary
                discretion, as appropriate, to consider prior authorization
                requirements for home infusion therapy services. Finally, section
                5012(c)(3) of the 21st Century Cures Act amended section 1861(m) of the
                Act to exclude home infusion therapy from the HH PPS beginning on
                January 1, 2021.
                (2) Bipartisan Budget Act of 2018
                 Section 50401 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
                123) amended section 1834(u) of the Act by adding a new paragraph (7)
                that established a home infusion therapy services temporary
                transitional payment for eligible home infusion suppliers for certain
                items and services furnished in coordination with the furnishing of
                transitional home infusion drugs, beginning January 1, 2019. This
                payment covers the same items and services as defined in section
                1861(iii)(2)(A) and (B) of the Act, furnished in coordination with the
                furnishing of transitional home infusion drugs. Section
                1834(u)(7)(A)(iii) of the Act defines the term ``transitional home
                infusion drug'' using the same definition as ``home infusion drug''
                under section 1861(iii)(3)(C) of the Act, which is a parenteral drug or
                biological administered intravenously, or subcutaneously for an
                administration period of 15 minutes or more, in the home of an
                individual through a pump that is an item of DME as defined under
                section 1861(n) of the Act. The definition of ``home infusion drug''
                excludes ``a self-administered drug or biological on a self-
                administered drug exclusion list'' but the definition of ``transitional
                home infusion drug'' notes that this exclusion shall not apply if a
                drug described in such clause is identified in clauses (i), (ii), (iii)
                or (iv) of 1834(u)(7)(C) of the Act. Section 1834(u)(7)(C) of the Act
                sets out the Healthcare Common Procedure Coding System (HCPCS) codes
                for the drugs and biologicals covered under the DME LCD for External
                Infusion Pumps (L33794),\10\ as the drugs covered during the temporary
                transitional period. In addition, section 1834(u)(7)(C) of the Act
                states that the Secretary shall assign to an appropriate payment
                category drugs which are covered under the DME LCD for External
                Infusion Pumps and billed under HCPCS codes J7799 (Not otherwise
                classified drugs, other than inhalation drugs, administered through
                DME) and J7999 (Compounded drug, not otherwise classified), or billed
                under any code that is implemented after the date of the enactment of
                this paragraph and included in such local coverage determination or
                included in subregulatory guidance as a home infusion drug.
                ---------------------------------------------------------------------------
                 \10\ Local Coverage Determination (LCD): External Infusion Pumps
                (L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
                ---------------------------------------------------------------------------
                 Section 1834(u)(7)(E)(i) of the Act states that payment to an
                eligible home infusion supplier or qualified home infusion therapy
                supplier for an infusion drug administration calendar day in the
                individual's home refers to payment only for the date on which
                professional services, as described in section 1861(iii)(2)(A) of the
                Act, were furnished to administer such drugs to such individual. This
                includes all such drugs administered to such individual on such day.
                Section 1842(u)(7)(F) of the Act defines ``eligible home infusion
                supplier'' as a supplier who is enrolled in Medicare as a pharmacy that
                provides external infusion pumps and external infusion pump supplies,
                and that maintains all pharmacy licensure requirements in the State in
                which the applicable infusion drugs are administered.
                 As set out at section 1834(u)(7)(C) of the Act, identified HCPCS
                codes for transitional home infusion drugs are assigned to three
                payment categories, as identified by their corresponding HCPCS codes,
                for which a single amount will be paid for home infusion therapy
                services furnished on each infusion drug administration calendar day.
                Payment category 1 includes certain intravenous infusion drugs for
                therapy, prophylaxis, or diagnosis, including antifungals and
                antivirals; inotropic and pulmonary hypertension drugs; pain management
                drugs; and chelation drugs. Payment category 2
                [[Page 39433]]
                includes subcutaneous infusions for therapy or prophylaxis, including
                certain subcutaneous immunotherapy infusions. Payment category 3
                includes intravenous chemotherapy infusions, including certain
                chemotherapy drugs and biologicals. The payment category for subsequent
                transitional home infusion drug additions to the LCD and compounded
                infusion drugs not otherwise classified, as identified by HCPCS codes
                J7799 and J7999, will be determined by the DME MACs.
                 In accordance with section 1834(u)(7)(D) of the Act, each payment
                category is paid at amounts in accordance with the Physician Fee
                Schedule (PFS) for each infusion drug administration calendar day in
                the individual's home for drugs assigned to such category, without
                geographic adjustment. Section 1834(u)(7)(E)(ii) of the Act requires
                that in the case that two (or more) home infusion drugs or biologicals
                from two different payment categories are administered to an individual
                concurrently on a single infusion drug administration calendar day, one
                payment for the highest payment category will be made.
                d. Summary of CY 2019 and CY 2020 Home Infusion Therapy Provisions
                 In the CY 2019 Home Health Prospective Payment System (HH PPS)
                final rule with comment period (83 FR 56579) we finalized the
                implementation of the home infusion therapy services temporary
                transitional payments under paragraph (7) of section 1834(u) of the
                Act, for CYs 2019 and 2020. These services are furnished in the
                individual's home to an individual who is under the care of an
                applicable provider (defined in section 1861(iii)(3)(A) of the Act as a
                physician, nurse practitioner, or physician's assistant) and where
                there is a plan of care established and periodically reviewed by a
                physician (defined at section 1861(r)(1) of the Act), prescribing the
                type, amount, and duration of infusion therapy services. Only eligible
                home infusion suppliers can bill for the temporary transitional
                payments. Therefore, in accordance with section 1834(u)(7)(F) of the
                Act, we clarified that this means that existing DME suppliers that are
                enrolled in Medicare as pharmacies that provide external infusion pumps
                and external infusion pump supplies, who comply with Medicare's DME
                Supplier and Quality Standards, and maintain all pharmacy licensure
                requirements in the State in which the applicable infusion drugs are
                administered, are considered eligible home infusion suppliers.
                 Section 1834(u)(7)(C) of the Act assigns transitional home infusion
                drugs, identified by the HCPCS codes for the drugs and biologicals
                covered under the DME LCD for External Infusion Pumps (L33794),\11\
                into three payment categories, for which we established a single
                payment amount in accordance with section 1834(u)(7)(D) of the Act.
                This section states that each single payment amount per category will
                be paid at amounts equal to the amounts determined under the PFS
                established under section 1848 of the Act for services furnished during
                the year for codes and units of such codes, without geographic
                adjustment. Therefore, we created a new HCPCS G-code for each of the
                three payment categories and finalized the billing procedure for the
                temporary transitional payment for eligible home infusion suppliers. We
                stated that the eligible home infusion supplier would submit, in line-
                item detail on the claim, a G-code for each infusion drug
                administration calendar day. We stated that the claim should include
                the length of time, in 15-minute increments, for which professional
                services were furnished. The G-codes can be billed separately from, or
                on the same claim as, the DME, supplies, or infusion drug, and are
                processed through the DME MACs. On August 10, 2018, we issued Change
                Request: R4112CP: Temporary Transitional Payment for Home Infusion
                Therapy Services for CYs 2019 and 2020 \12\ outlining the requirements
                for the claims processing changes needed to implement this payment.
                ---------------------------------------------------------------------------
                 \11\ Local Coverage Determination (LCD): External Infusion Pumps
                (L33794). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33794&ver=83&Date=05%2f15%2f2019&DocID=L33794&bc=iAAAABAAAAAA&.
                 \12\ Temporary Transitional Payment for Home Infusion Therapy
                Services for CYs 2019 and 2020. August 10, 2018. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4112CP.pdf.
                ---------------------------------------------------------------------------
                 And last, we finalized the definition of ``infusion drug
                administration calendar day'' in regulation as the day on which home
                infusion therapy services are furnished by skilled professional(s) in
                the individual's home on the day of infusion drug administration. The
                skilled services provided on such day must be so inherently complex
                that they can only be safely and effectively performed by, or under the
                supervision of, professional or technical personnel (42 CFR 486.505).
                Section 1834(u)(7)(E)(i) of the Act clarifies that this definition is
                with respect to the furnishing of ``transitional home infusion drugs''
                and ``home infusion drugs'' to an individual by an ``eligible home
                infusion supplier'' and a ``qualified home infusion therapy supplier.''
                The definition of ``infusion drug administration calendar day'' applies
                to both the temporary transitional payment in CYs 2019 and 2020 and the
                permanent home infusion therapy services benefit to be implemented
                beginning in CY 2021.
                2. Summary of Home Infusion Therapy Services for CY 2021 and Subsequent
                Years
                 Upon completion of the temporary transitional payments for home
                infusion therapy services at the end of CY 2020, we will be
                implementing the permanent payment system for home infusion therapy
                services under Section 5012 of the 21st Century Cures Act (Pub. L. 114-
                255) beginning January 1, 2021. In the CY 2020 HH PPS final rule with
                comment period, we finalized provisions regarding payment for home
                infusion therapy services for CY 2021 and subsequent years in order to
                allow adequate time for eligible home infusion therapy suppliers to
                make any necessary software and business process changes for
                implementation on January 1, 2021.
                a. Scope of Benefit and Conditions for Payment
                 Section 1861(iii) of the Act establishes certain provisions related
                to home infusion therapy with respect to the requirements that must be
                met for Medicare payment to be made to qualified home infusion therapy
                suppliers. These provisions serve as the basis for determining the
                scope of the home infusion drugs eligible for coverage of home infusion
                therapy services, outlining beneficiary qualifications and plan of care
                requirements, and establishing who can bill for payment under the
                benefit.
                (1) Home Infusion Drugs
                 In the CYs 2019 and 2020 Home Health Prospective Payment System (HH
                PPS) proposed rules (83 FR 32466 and 84 FR 34690) we discussed the
                relationship between the home infusion therapy services benefit and the
                DME benefit. We stated that, as there is no separate Medicare Part B
                DME payment for the professional services associated with the
                administration of certain home infusion drugs covered as supplies
                necessary for the effective use of external infusion pumps, we consider
                the home infusion therapy services benefit to be a separate payment in
                addition to the existing payment for the DME equipment, accessories,
                and supplies (including the home infusion drug) made under the DME
                benefit. We stated that, consistent with the
                [[Page 39434]]
                definition of ``home infusion therapy,'' the home infusion therapy
                services payment explicitly and separately pays for the professional
                services related to the administration of the drugs identified on the
                DME LCD for External Infusion Pumps (L33794),\13\ when such services
                are furnished in the individual's home. For purposes of the temporary
                transitional payments for home infusion therapy services in CYs 2019
                and 2020, the term ``transitional home infusion drug'' includes the
                HCPCS codes for the drugs and biologicals covered under the DME LCD for
                External Infusion Pumps (L33794).\14\ We also noted that although
                section 1834(u)(7)(A)(iii) of the Act defines the term ``transitional
                home infusion drug,'' section 1834(u)(7)(A)(iii) of the Act does not
                specify the HCPCS codes for ``home infusion drugs'' for which home
                infusion therapy services would be covered beginning in CY 2021.
                ---------------------------------------------------------------------------
                 \13\ Local Coverage Determination (LCD): External Infusion Pumps
                (L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
                 \14\ Local Coverage Determination (LCD): External Infusion Pumps
                (L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
                ---------------------------------------------------------------------------
                 Section 1861(iii)(3)(C) of the Act defines ``home infusion drug''
                as a parenteral drug or biological administered intravenously, or
                subcutaneously for an administration period of 15 minutes or more, in
                the home of an individual through a pump that is an item of durable
                medical equipment (as defined in section 1861(n) of the Act). Such term
                does not include insulin pump systems or self-administered drugs or
                biologicals on a self-administered drug exclusion list. This definition
                not only specifies that the drug or biological must be administered
                through a pump that is an item of DME, but references the statutory
                definition of DME at 1861(n) of the Act. This means that ``home
                infusion drugs'' are drugs and biologicals administered through a pump
                that is covered under the Medicare Part B DME benefit. Therefore, in
                the CY 2020 HH PPS final rule with comment period (84 FR 60618), we
                stated that this means that ``home infusion drugs'' are defined as
                parenteral drugs and biologicals administered intravenously, or
                subcutaneously for an administration period of 15 minutes or more, in
                the home of an individual through a pump that is an item of DME covered
                under the Medicare Part B DME benefit, pursuant to the statutory
                definition set out at section 1861(iii)(3)(C) of the Act, and
                incorporated by cross reference at section 1834(u)(7)(A)(iii) of the
                Act.
                (2) Patient Eligibility and Plan of Care Requirements
                 Subparagraphs (A) and (B) of section 1861(iii)(1) of the Act set
                forth beneficiary eligibility and plan of care requirements for ``home
                infusion therapy.'' In accordance with section 1861(iii)(1)(A) of the
                Act, the beneficiary must be under the care of an applicable provider,
                defined in section 1861(iii)(3)(A) of the Act as a physician, nurse
                practitioner, or physician assistant. In accordance with section
                1861(iii)(1)(B) of the Act, the beneficiary must also be under a plan
                of care, established by a physician (defined at section 1861(r)(1) of
                the Act), prescribing the type, amount, and duration of infusion
                therapy services that are to be furnished, and periodically reviewed,
                in coordination with the furnishing of home infusion drugs under Part
                B. Based on these statutory requirements, and in accordance with the
                standards at Sec. 486.520, we finalized the home infusion therapy
                services conditions for payment at 42 CFR part 414, subpart P via the
                CY 2020 HH PPS final rule with comment period (84 FR 34690).
                (3) Qualified Home Infusion Therapy Suppliers and Professional Services
                 Section 1861(iii)(3)(D)(i) of the Act defines a ``qualified home
                infusion therapy supplier'' as a pharmacy, physician, or other provider
                of services or supplier licensed by the State in which the pharmacy,
                physician, or provider of services or supplier furnishes items or
                services. The qualified home infusion therapy supplier must: Furnish
                infusion therapy to individuals with acute or chronic conditions
                requiring administration of home infusion drugs; ensure the safe and
                effective provision and administration of home infusion therapy on a 7-
                day-a-week, 24-hour a-day basis; be accredited by an organization
                designated by the Secretary; and meet such other requirements as the
                Secretary determines appropriate.
                 Section 1861(iii)(2) of the Act defines home infusion therapy to
                include the following items and services: The professional services,
                including nursing services, furnished in accordance with the plan,
                training and education (not otherwise paid for as DME), remote
                monitoring, and other monitoring services for the provision of home
                infusion therapy and home infusion drugs furnished by a qualified home
                infusion therapy supplier, which are furnished in the individual's
                home. Section 1861(iii)(2) of the Act does not define home infusion
                therapy services to include the pump, home infusion drug, or related
                services. Therefore, in the CY 2020 HH PPS final rule with comment
                period, we noted that the infusion pump, drug, and other supplies, and
                the services required to furnish these items (that is, the compounding
                and dispensing of the drug) remain covered under the DME benefit.
                 We stated in the CY 2020 HH PPS proposed rule that we did not
                specifically enumerate a list of ``professional services'' for which
                the qualified home infusion therapy supplier is responsible in order to
                avoid limiting services or the involvement of providers of services or
                suppliers that may be necessary in the care of an individual patient
                (84 FR 34692). However, we noted that, under section 1862(a)(1)(A) of
                the Act, no payment can be made for Medicare services under Part B that
                are not reasonable and necessary for the diagnosis or treatment of
                illness or injury or to improve the functioning of a malformed body
                member, unless explicitly authorized by statutes. We stated that this
                means that the qualified home infusion therapy supplier is responsible
                for the reasonable and necessary services related to the administration
                of the home infusion drug in the individual's home. These services may
                require some degree of care coordination or monitoring outside of an
                infusion drug administration calendar day. However, payment for these
                services is built into the bundled payment for an infusion drug
                administration calendar day.
                 Payment to a qualified home infusion therapy supplier is for an
                infusion drug administration calendar day in the individual's home,
                which, in accordance with section 1834(u)(7)(E) of the Act, refers to
                payment only for the date on which professional services were furnished
                to administer such drugs to such individual. Ultimately, the qualified
                home infusion therapy supplier is the entity responsible for furnishing
                the necessary services to administer the drug in the home and, as we
                noted in the CY 2019 HH PPS final rule with comment period (83 FR
                56581), ``administration'' refers to the process by which the drug
                enters the patient's body. Therefore, it is necessary for the qualified
                home infusion therapy supplier to be in the patient's home, on
                occasions when the drug is being administered in order to provide an
                accurate assessment to the physician responsible for ordering the home
                infusion drug and services. The services provided would include patient
                [[Page 39435]]
                evaluation and assessment; training and education of patients and their
                caretakers, assessment of vascular access sites and obtaining any
                necessary bloodwork; and evaluation of medication administration.
                However, visits made solely for the purposes of venipuncture on days
                where there is no administration of the infusion drug would not be
                separately paid because the single payment includes all services for
                administration of the drug. Payment for an infusion drug administration
                calendar day is a bundled payment, which reflects not only the visit
                itself, but any necessary follow-up work (which could include visits
                for venipuncture), or care coordination provided by the qualified home
                infusion therapy supplier. Any care coordination, or visits made for
                venipuncture, provided by the qualified home infusion therapy supplier
                that occurs outside of an infusion drug administration calendar day
                would be included in the payment for the visit (83 FR 56581).
                 Additionally, section 1861(iii)(1)(B) of the Act requires that the
                patient be under a plan of care established and periodically reviewed
                by a physician, in coordination with the furnishing of home infusion
                drugs. The physician is responsible for ordering the reasonable and
                necessary services for the safe and effective administration of the
                home infusion drug, as indicated in the patient plan of care. In
                accordance with this section, the physician is responsible for
                coordinating the patient's care in consultation with the DME supplier
                furnishing the infusion pump and the home infusion drug. We recognize
                that collaboration between the ordering physician and the DME supplier
                furnishing the home infusion drug is imperative in providing safe and
                effective home infusion. Payment for physician services, including any
                home infusion care coordination services, are separately paid to the
                physician under the PFS and are not covered under the home infusion
                therapy services benefit. However, payment under the home infusion
                therapy services benefit to eligible home infusion therapy suppliers is
                for the professional services that inform collaboration between
                physicians and home infusion therapy suppliers. Care coordination
                between the physician and DME supplier, although likely to include
                review of the services indicated in the home infusion therapy supplier
                plan of care, is paid separately from the payment under the home
                infusion therapy services benefit.
                 As discussed in the CY 2020 HH PPS proposed rule, the DME quality
                standards require the supplier to review the patient's record and
                consult with the prescribing physician as needed to confirm the order
                and to recommend any necessary changes, refinements, or additional
                evaluations to the prescribed equipment, item(s), and/or service(s) (84
                FR 34692). Follow-up services to the beneficiary and/or caregiver(s),
                must be consistent with the type(s) of equipment, item(s) and
                service(s) provided, and include recommendations from the prescribing
                physician or healthcare team member(s).\15\ Additionally, DME suppliers
                are required to communicate directly with patients regarding their
                medications.
                ---------------------------------------------------------------------------
                 \15\ Durable Medical Equipment, Prosthetics, Orthotics, and
                Supplies (DMEPOS) Quality Standards. https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Downloads/Final-DMEPOS-Quality-Standards-Eff-01-09-2018.pdf.
                ---------------------------------------------------------------------------
                 In summary, the qualified home infusion therapy supplier is
                responsible for the reasonable and necessary services related to the
                administration of the home infusion drug in the individual's home.
                These services may require some degree of care coordination or
                monitoring outside of an infusion drug administration calendar day;
                payment for these services is built into the bundled payment for an
                infusion drug administration calendar day. Furthermore, as we noted in
                the CY 2019 HH PPS proposed rule, we consider the home infusion benefit
                principally to be a separate payment in addition to the existing
                payment made under the DME benefit, thus explicitly and separately
                paying for the home infusion therapy services (83 FR 32466). Therefore,
                the professional services covered under the DME benefit are not covered
                under the home infusion benefit. While the two benefits exist in
                tandem, the services are unique to each benefit and billed and paid for
                under separate payment systems.
                (4) Home Infusion Therapy and Interaction With the Home Health Benefit
                 Because a qualified home infusion therapy supplier is not required
                to become accredited as a Part B DME supplier or to furnish the home
                infusion drug, and because payment is determined by the provision of
                services furnished in the patient's home, we acknowledged in the CY
                2019 HH PPS proposed rule the potential for overlap between the new
                home infusion therapy services benefit and the home health benefit (83
                FR 32469). We stated that a beneficiary is not required to be
                considered homebound in order to be eligible for the home infusion
                therapy services benefit; however, there may be instances where a
                beneficiary under a home health plan of care also requires home
                infusion therapy services. Additionally, because section 5012 of the
                21st Century Cures Act amends section 1861(m) of the Act to exclude
                home infusion therapy from home health services effective on January 1,
                2021, we stated that a beneficiary may utilize both benefits
                concurrently.
                 Furthermore, because both the home health agency and the qualified
                home infusion therapy supplier furnish services in the individual's
                home, and may potentially be the same entity, the best process for
                payment for furnishing home infusion therapy services to beneficiaries
                who qualify for both benefits is as outlined in the CY 2019 HH PPS
                proposed rule (83 FR 32469). If a patient receiving home infusion
                therapy is also under a home health plan of care, and receives a visit
                that is unrelated to home infusion therapy, then payment for the home
                health visit would be covered by the HH PPS and billed on the home
                health claim. When the home health agency furnishing home health
                services is also the qualified home infusion therapy supplier
                furnishing home infusion therapy services, and a home visit is
                exclusively for the purpose of furnishing items and services related to
                the administration of the home infusion drug, the home health agency
                would submit a home infusion therapy services claim under the home
                infusion therapy services benefit. If the home visit includes the
                provision of other home health services in addition to, and separate
                from, home infusion therapy services, the home health agency would
                submit both a home health claim under the HH PPS and a home infusion
                therapy services claim under the home infusion therapy services
                benefit. However, the agency must separate the time spent furnishing
                services covered under the HH PPS from the time spent furnishing
                services covered under the home infusion therapy services benefit. DME
                is excluded from the consolidated billing requirements governing the HH
                PPS (42 CFR 484.205) and therefore, the DME items and services
                (including the home infusion drug and related services) will continue
                to be paid for outside of the HH PPS. If the qualified home infusion
                therapy supplier is not the same entity as the home health agency
                furnishing the home health services, the home health agency would
                continue to bill under the HH PPS on the home health claim, and the
                qualified home infusion therapy supplier would
                [[Page 39436]]
                bill for the services related to the administration of the home
                infusion drugs on the home infusion therapy services claim.
                b. Notification of Infusion Therapy Options Available Prior To
                Furnishing Home Infusion Therapy Services
                 Section 1834(u)(6) of the Act requires that prior to the furnishing
                of home infusion therapy services to an individual, the physician who
                establishes the plan described in section 1861(iii)(1) of the Act for
                the individual shall provide notification (in a form, manner, and
                frequency determined appropriate by the Secretary) of the options
                available (such as home, physician's office, hospital outpatient
                department) for the furnishing of infusion therapy under this part.
                 We recognize there are several possible forms, manners, and
                frequencies that physicians may use to notify patients of their
                infusion therapy options. We solicited comments in the CY 2020 PFS
                proposed rule (84 FR 40716) and the CY 2020 HH PPS proposed rule (84 FR
                34694), regarding the appropriate form, manner, and frequency that any
                physician must use to provide notification of the treatment options
                available to his/her patient for the furnishing of infusion therapy
                (home or otherwise) under Medicare Part B. We also invited comments on
                any additional interpretations of this notification requirement. We
                summarized the comments received in the CY 2020 PFS final rule (84 FR
                62568) and the CY 2020 HH PPS final rule with comment period (84 FR
                60478), and we stated we would take these comments into consideration
                as we continue developing future policy through notice-and-comment
                rulemaking.
                 Many commenters stated that physicians already routinely discuss
                the infusion therapy options with their patients and annotate these
                discussions in their patients' medical records. For home infusion
                therapy services effective beginning CY 2021, physicians are to
                continue with the current practice of discussing options available for
                furnishing infusion therapy under Part B and annotating these
                discussions in their patients' medical records prior to establishing a
                home infusion therapy plan of care. We are not proposing to create a
                mandatory form nor are we otherwise proposing to require a specific
                manner or frequency of notification of options available for infusion
                therapy under Part B prior to establishing a home infusion therapy plan
                of care, as we believe that current practice provides appropriate
                notification. However, if current practice is later found to be
                insufficient in providing appropriate notification to patients of the
                available infusion options under Part B, we may consider additional
                requirements regarding this notification in future rulemaking.
                3. Payment Categories and Payment Amounts for Home Infusion Therapy
                Services for CY 2021
                 Section 1834(u)(1) of the Act provides the authority for the
                development of a payment system for Medicare-covered home infusion
                therapy services. In accordance with section 1834(u)(1)(A)(i) of the
                Act, the Secretary is required to implement a payment system under
                which a single payment is made to a qualified home infusion therapy
                supplier for items and services furnished by a qualified home infusion
                therapy supplier in coordination with the furnishing of home infusion
                drugs. Section 1834(u)(1)(A)(ii) of the Act states that a unit of
                single payment under this payment system is for each infusion drug
                administration calendar day in the individual's home, and requires the
                Secretary, as appropriate, to establish single payment amounts for
                different types of infusion therapy, taking into account variation in
                utilization of nursing services by therapy type. Section
                1834(u)(1)(A)(iii) of the Act provides a limitation to the single
                payment amount, requiring that it shall not exceed the amount
                determined under the PFS (under section 1848 of the Act) for infusion
                therapy services furnished in a calendar day if furnished in a
                physician office setting. Furthermore, such single payment shall not
                reflect more than 5 hours of infusion for a particular therapy in a
                calendar day. This permanent payment system would become effective for
                home infusion therapy items and services furnished on or after January
                1, 2021.
                 In accordance with section 1834(u)(1)(A)(ii) of the Act, a unit of
                single payment for each infusion drug administration calendar day in
                the individual's home must be established for types of infusion
                therapy, taking into account variation in utilization of nursing
                services by therapy type. Furthermore, section 1834(u)(1)(B)(ii) of the
                Act requires that the payment amount reflect factors such as patient
                acuity and complexity of drug administration. We believe that the best
                way to establish a single payment amount that varies by utilization of
                nursing services and reflects patient acuity and complexity of drug
                administration, is to group home infusion drugs by J-code into payment
                categories reflecting similar therapy types. Therefore, each payment
                category would reflect variations in infusion drug administration
                services.
                 Section 1834(u)(7)(C) of the Act established three payment
                categories, with the associated J-code for each transitional home
                infusion drug (see Table 12), for the home infusion therapy services
                temporary transitional payment. Payment category 1 comprises certain
                intravenous infusion drugs for therapy, prophylaxis, or diagnosis,
                including, but not limited to, antifungals and antivirals; inotropic
                and pulmonary hypertension drugs; pain management drugs; and chelation
                drugs. Payment category 2 comprises subcutaneous infusions for therapy
                or prophylaxis, including, but not limited to, certain subcutaneous
                immunotherapy infusions. Payment category 3 comprises intravenous
                chemotherapy infusions, including certain chemotherapy drugs and
                biologicals.
                a. CY 2021 Payment Categories for Home Infusion Therapy Services
                 In the CY 2020 HH PPS final rule with comment period (84 FR 60478),
                we finalized our proposal to maintain the three payment categories
                utilized under the temporary transitional payments for home infusion
                therapy services. Maintaining the three current payment categories,
                with the associated J-codes as outlined in section 1834(u)(7)(C) of the
                Act, utilizes an already established framework for assigning a unit of
                single payment (per category), accounting for different therapy types,
                as required by section 1834(u)(1)(A)(ii) of the Act. The payment amount
                for each of these three categories is different, though each category
                has its associated single payment amount. The single payment amount
                (per category) would thereby reflect variations in nursing utilization,
                complexity of drug administration, and patient acuity, as determined by
                the different categories based on therapy type. Retaining the three
                current payment categories maintains consistency with the already
                established payment methodology and ensures a smooth transition between
                the temporary transitional payments and the permanent payment system to
                be implemented beginning with 2021. Table 12 provides the list of J-
                codes associated with the infusion drugs that fall within each of the
                payment categories. There are some drugs that are paid for under the
                transitional benefit but would not be defined as a home infusion drug
                under the permanent benefit beginning with 2021. As noted previously in
                this proposed rule, section 1861(iii)(3)(C) of the Act defines a home
                [[Page 39437]]
                infusion drug as a parenteral drug or biological administered
                intravenously or subcutaneously for an administration period of 15
                minutes or more, in the home of an individual through a pump that is an
                item of DME. Such term does not include the following: (1) Insulin pump
                systems; and (2) a self-administered drug or biological on a self-
                administered drug exclusion list. Hizentra, a subcutaneous
                immunoglobulin, is not included in this definition of home infusion
                drugs because it is listed on a self-administered drug (SAD) exclusion
                list by the MACs. This drug was included as a transitional home
                infusion drug since the definition of such drug in section
                1834(u)(7)(A)(iii) of the Act does not exclude self-administered drugs
                or biologicals on a SAD exclusion list under the temporary transitional
                payment. Therefore, although home infusion therapy services related to
                the administration of Hizentra are covered under the temporary
                transitional payment, because it is on a SAD exclusion list, services
                related to the administration of this biological are not covered under
                the benefit in 2021. Similarly, in accordance with the definition of
                ``home infusion drug'' as a parenteral drug or biological administered
                intravenously or subcutaneously, home infusion therapy services related
                to the administration of Ziconotide and Floxuridine are also excluded,
                as these drugs are given via intrathecal and intra-arterial routes
                respectively and therefore do not meet the definition of home infusion
                drug. Likewise, home infusion therapy services related to the
                intrathecal administration of Morphine, identified by HCPCS code J2274,
                is excluded because intrathecal administration does not meet the
                definition of a home infusion drug under the permanent benefit.
                Subsequent drugs added to the DME LCD for external infusion pumps, and
                compounded infusion drugs not otherwise classified, as identified by
                HCPCS codes J7799 and J7999, would be grouped into the appropriate
                payment category by the DME MACs. Payment category 1 would include any
                subsequent intravenous infusion drug additions, payment category 2
                would include any subsequent subcutaneous infusion drug additions, and
                payment category 3 would include any subsequent intravenous
                chemotherapy or other highly complex drug or biologic infusion
                additions.
                [[Page 39438]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.101
                b. CY 2021 Payment Amounts for Home Infusion Therapy Services
                 Section 1834(u)(1)(A)(ii) of the Act requires that the payment
                amount take into account variation in utilization of nursing services
                by therapy type. Additionally, section 1834(u)(1)(A)(iii) of the Act
                provides a limitation that the single payment shall not exceed the
                amount determined under the fee schedule under section 1848 of the Act
                for infusion therapy services furnished in a calendar day if furnished
                in a physician office setting, except such single payment shall not
                reflect more than 5 hours of infusion for a particular therapy in a
                calendar day. Finally, section 1834(u)(1)(B)(ii) of the Act requires
                the payment amount to reflect patient acuity and complexity of drug
                administration.
                 Currently, as set out at section 1834(u)(7)(D) of the Act, each
                temporary transitional payment category is paid at amounts in
                accordance with six infusion CPT codes and units of such codes under
                the PFS. These payment category amounts are set equal to 4 hours of
                infusion therapy administration services in a physician's office for
                each infusion drug administration calendar day, regardless of the
                length of the visit. In the CY 2020 HH PPS final rule with comment
                period (84 FR 60478), we finalized that the payment amounts per
                category, for an infusion drug administration calendar day under the
                permanent benefit, be in accordance with the six PFS infusion CPT codes
                and units for such codes, as described in section 1834(u)(7)(D) of the
                [[Page 39439]]
                Act. However, we set the amount equivalent to 5 hours of infusion in a
                physician's office, rather than 4 hours. Each payment category amount
                would be in accordance with the six infusion CPT codes identified in
                section 1834(u)(7)(D) of the Act and as shown in Table 13.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.102
                 We also finalized the proposal to increase the payment amounts for
                each of the three payment categories for the first home infusion
                therapy visit by the qualified home infusion therapy supplier in the
                patient's home by the average difference between the PFS amounts for E/
                M existing patient visits and new patient visits for a given year,
                resulting in a small decrease to the payment amounts for the second and
                subsequent visits, using a budget neutrality factor. Table 14 shows the
                E/M visit codes and PFS payment amounts for CY 2020, for both new and
                existing patients, used to determine the increased payment amount for
                the first visit. Using the CY 2020 PFS rates, this results in a 60
                percent increase in the first visit payment amount and a 3.72 percent
                decrease in subsequent visit amounts.
                [GRAPHIC] [TIFF OMITTED] TP30JN20.103
                 Table 15 shows the 5-hour payment amounts (using CY 2020 PFS rates)
                reflecting the increased payment for the first visit and the decreased
                payment for all subsequent visits. The payment amounts for this
                proposed rule are estimated using CY 2020 rates because the CY 2021 PFS
                rates are not available at the time of this rule making. The final home
                infusion 5-hour payment amounts will be released in a CR when the final
                CY 2021 PFS rates are posted. We plan on monitoring home infusion
                therapy service lengths of visits, both initial and subsequent, in
                order to evaluate whether the data substantiates this increase or
                whether we should re-evaluate whether, or how much, to increase the
                initial visit payment amount.
                [[Page 39440]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.104
                4. Payment Adjustments for CY 2021 Home Infusion Therapy Services
                a. Home Infusion Therapy Geographic Wage Index Adjustment
                 Section 1834(u)(1)(B)(i) of the Act requires that the single
                payment amount be adjusted to reflect a geographic wage index and other
                costs that may vary by region. In the 2020 HH PPS final rule with
                comment period (84 FR 60478, 60629) we finalized the use of the
                Geographic Adjustment Factor (GAF) to adjust home infusion therapy
                payments based on differences in geographic wages. The GAF is a
                weighted composite of each PFS locality's work, practice expense (PE),
                and malpractice (MP) GPCIs and represents the combined impact of the
                three GPCI components. The GAF is calculated by multiplying the work,
                PE, and MP GPCIs by the corresponding national cost share weight: Work
                (50.886 percent), PE (44.839 percent), and MP (4.295 percent).\16\ The
                GAF is not specific to any of the home infusion drug categories, so the
                GAF payment rate would equal the unadjusted rate multiplied by the GAF
                for each locality level, without a labor share adjustment. As such,
                based on locality, the GAF adjusted payment rate would be calculated
                using the following formula:
                ---------------------------------------------------------------------------
                 \16\ GAF = (.50886 x Work GPCI) + (.44839 x PE GPCI) + (.04295 x
                MP GPCI).
                ---------------------------------------------------------------------------
                Rate GAFi = GAF * UnadjRatei.
                 The appropriate GAF value is applied to the home infusion therapy
                single payment amount based on the site of service of the beneficiary
                and the adjustment will happen on the PFS based on the beneficiary zip
                code submitted on the 837P/CMS-1500 professional and supplier claims
                form. We finalized that the application of the GAF will be budget
                neutral so there is no overall cost impact. However, this will result
                in some adjusted payments being higher than the average and others
                being lower. In order to make the application of the GAF budget neutral
                we will apply a budget-neutrality factor. If the rates were set for
                2020 the budget neutrality factor would be 0.9957. The GAF conversion
                factor equals the ratio of the estimated unadjusted national spending
                total to the estimated GAF-adjusted national spending total. Estimates
                of national spending totals are derived from a function of
                ``beneficiary counts,'' ``weeks of care,'' and ``estimated visits of
                care'' by home infusion therapy drug payment category, which were
                compiled from CY 2019 utilization data. We define home infusion therapy
                beneficiaries as Medicare beneficiaries with at least one home infusion
                therapy drug prescription fill in CY 2019, and weeks of care for each
                home infusion therapy beneficiary equal the number of weeks between
                (and including) the first prescription fill in CY 2019 and the last
                prescription fill in CY2019. Weeks of care are then transformed into
                ``estimated visits of care,'' where we assumed 2 visits for the initial
                week of care, with 1 visit per week for all subsequent weeks for
                categories 1 and 3, and we assumed 1 visit per month, or 12 visits per
                year, for category 2.
                 The list of GAFs by locality for this proposed rule is available as
                a downloadable file at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html.
                b. Consumer Price Index
                 Subparagraphs (A) and (B) of section 1834(u)(3) of the Act specify
                annual adjustments to the single payment amount that are required to be
                made beginning January 1, 2022. In accordance with these sections we
                would increase the single payment amount by the percent increase in the
                Consumer Price Index for all urban consumers (CPI-U) for the 12-month
                period ending with June of the preceding year, reduced by the 10-year
                moving average of changes in annual economy-wide private nonfarm
                business multifactor productivity (MFP). Accordingly, this may result
                in a percentage being less than 0.0 for a year, and may result in
                payment being less than such payment rates for the preceding year.
                5. Proposed Home Infusion Therapy Services Excluded From the Medicare
                Home Health Benefit
                 Section 1861(iii) of the Act defines ``home infusion therapy'' as
                the items and services described in paragraph (2), furnished by a
                qualified home infusion therapy supplier which are furnished in the
                individual's home. In accordance with Sec. 486.525, the required items
                and services covered under the home infusion therapy services benefit
                are as follows:
                 Professional services, including nursing services,
                furnished in accordance with the plan.
                 Training and education (not otherwise paid for as DME).
                 Remote monitoring, and monitoring services for the
                provision of home infusion drugs furnished by a qualified home infusion
                therapy supplier.
                 The CY 2019 HH PPS proposed rule described the professional and
                nursing services, as well as the training, education, and monitoring
                services included in the payment to a qualified home infusion therapy
                supplier for the provision of home infusion drugs (83 FR
                [[Page 39441]]
                32467). In accordance with the definition of ``infusion drug
                administration calendar day'', the skilled services provided on an
                infusion drug administration calendar day must be so inherently complex
                that they can only be safely and effectively performed by, or under the
                supervision of, professional or technical personnel. Additionally,
                although we do not specify the entities that may provide the home
                infusion therapy services, we do state that the skilled provider must
                be furnishing services within the scope of his/her practice. While we
                do not outline an exhaustive list of services that are covered under
                the home infusion therapy services benefit, we outline the scope of
                services covered under the home infusion therapy services benefit in
                sub-regulatory guidance.\17\ This guidance states that the home
                infusion therapy services benefit is intended to be a separate payment
                explicitly covering the professional services, training and education
                (not covered under the DME benefit), and monitoring and remote
                monitoring services for the provision of home infusion drugs. We state
                that these services may include, for example the following:
                ---------------------------------------------------------------------------
                 \17\ MLN Matters: SE19029: Medicare Part B Home Infusion Therapy
                Services With the Use of Durable Medical Equipment. December 13,
                2019. https://www.cms.gov/files/document/se19029.pdf.
                 And Temporary Transitional Payment FAQs. February 27, 2019.
                https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Downloads/Home-Infusion-Therapy-Services-Temp-Transitional-Payment-FAQs.pdf.
                ---------------------------------------------------------------------------
                 Training and education on care and maintenance of vascular
                access devices--
                 ++ Hygiene Education;
                 ++ Instruction on what to do in the event of a dislodgement or
                occlusion;
                 ++ Education on signs and symptoms of infection; and
                 ++ Teaching and training on flushing and locking the catheter.
                 Dressing changes and site care.
                 Patient assessment and evaluation--
                 ++ Review history and assess current physical and mental status,
                including obtaining vital signs;
                 ++ Assess any adverse effects or infusion complications;
                 ++ Evaluate family and caregiver support;
                 ++ Review prescribed treatment and any concurrent oral and/or over-
                the-counter treatments; and
                 ++ Obtain blood for laboratory work
                 Medication and disease management education--
                 ++ Instruction on self-monitoring;
                 ++ Education on lifestyle and nutritional modifications;
                 ++ Education regarding drug mechanism of action, side effects,
                interactions with other medications, adverse and infusion-related
                reactions;
                 ++ Education regarding therapy goals and progress;
                 ++ Instruction on administering pre-medications and inspection of
                medication prior to use;
                 ++ Education regarding household and contact precautions and/or
                spills;
                 Remote monitoring services.
                 Monitoring services--
                 ++ Communicate with patient regarding changes in condition and
                treatment plan;
                 ++ Monitor patient response to therapy; and
                 ++ Assess compliance.
                 This list is not intended to be prescriptive or all-inclusive, as
                the physician is responsible for ordering the reasonable and necessary
                services for the safe and effective administration of the home infusion
                drug.
                 Section 5012 of the 21st Century Cures Act amended section 1861(m)
                of the Act to exclude home infusion therapy from the definition of home
                health services, effective on January 1, 2021. While patients needing
                home infusion therapy are not required to be eligible for the home
                health benefit, they are not prohibited from utilizing both the home
                infusion therapy and home health benefits concurrently. It is also
                likely that many home health agencies will become accredited and enroll
                as qualified home infusion therapy suppliers. Therefore, because a home
                health agency may furnish services for a patient receiving both home
                health services and home infusion therapy services, it is necessary to
                exclude in regulation the scope of professional services, training and
                education, as well as monitoring and remote monitoring services, for
                the provision of home infusion drugs, as defined at Sec. 486.505, from
                the services covered under the home health benefit. It is important to
                note that the home infusion therapy services distinct from those which
                are required and furnished under the home health benefit, are only for
                the provision of home infusion drugs. When a home health agency is
                furnishing services to a patient receiving an infusion drug not defined
                as a home infusion drug at Sec. 486.505, those services may still be
                covered as home health services.
                 In accordance with the conforming amendment in section 5012(c)(3)
                of the 21st Century Cures Act, which amended section 1861(m) of the Act
                to exclude home infusion therapy from the definition of home health
                services, we propose to amend Sec. 409.49 to exclude services covered
                under the home infusion therapy services benefit from the home health
                benefit. Any services that are covered under the home infusion therapy
                services benefit as outlined at Sec. 486.525, including any home
                infusion therapy services furnished to a Medicare beneficiary that is
                under a home health plan of care, are excluded from coverage under the
                Medicare home health benefit. Additionally, excluded home infusion
                therapy services pertain to the items and services for the provision of
                home infusion drugs, as defined at Sec. 486.505. Services for the
                provision of drugs and biologicals not covered under this definition
                may continue to be provided under the Medicare home health benefit.
                 As discussed in the CY 2019 HH PPS proposed rule (83 FR 32469), if
                a patient is under a home health plan of care, and a home health visit
                is furnished that is unrelated to home infusion therapy, then payment
                for the home health visit would be covered by the HH PPS and billed on
                the same home health claim. If the HHA providing services under the
                Medicare home health benefit is also the same entity furnishing
                services as the qualified home infusion therapy supplier, and a home
                visit is exclusively for the purpose of furnishing home infusion
                therapy services, the HHA would submit a claim for payment as a home
                infusion therapy supplier and receive payment under the home infusion
                therapy services benefit. If the home visit includes the provision of
                home health services in addition to, and separate from, items and
                services related to home infusion therapy, the HHA would submit both a
                home health claim and a home infusion therapy services claim, and must
                separate the time spent performing services covered under the HH PPS
                from the time spent performing services covered under the home infusion
                therapy services benefit.
                B. Proposed Enrollment Standards for Qualified Home Infusion Therapy
                Suppliers
                 As previously alluded to, regulatory provisions pertaining to home
                infusion therapy have been established in various parts of Title 42 of
                the CFR. For example, part 414, subpart P outlines policies concerning
                home infusion therapy conditions of payment and plan of care
                requirements. Part 486, subpart I, outlines standards for home infusion
                therapy suppliers and specifies a definition of ``qualified home
                infusion therapy supplier'' at Sec. 486.505. This latter term means a
                supplier of home infusion therapy that meets all of the following
                criteria, which are set forth at section 1861(iii)(3)(D)(i) of the Act:
                [[Page 39442]]
                 Furnishes infusion therapy to individuals with acute or
                chronic conditions requiring administration of home infusion drugs.
                 Ensures the safe and effective provision and
                administration of home infusion therapy on a 7-day-a-week, 24-hour-a-
                day basis.
                 Is accredited by an organization designated by the
                Secretary in accordance with section 1834(u)(5) of the Act.
                 Meets such other requirements as the Secretary determines
                appropriate.
                 This final criterion, which reflects section 1861(iii)(3)(D)(i)(IV)
                of the Act, is of particular importance for purposes of this section
                V.B. of this proposed rule. One of our principal oversight roles is to
                protect the Medicare program from fraud, waste, and abuse. This is
                accomplished in part through the careful screening and monitoring of
                prospective and existing providers and suppliers. We believe that
                section 1861(iii)(3)(D)(i)(IV) of the Act permits the Secretary to take
                steps in this direction with respect to home infusion therapy
                suppliers.
                1. Medicare Provider and Supplier Enrollment
                a. Background
                 Section 1866(j)(1)(A) of the Act requires the Secretary to
                establish a process for the enrollment of providers and suppliers in
                the Medicare program. The overarching purpose of the enrollment process
                is to help ensure that providers and suppliers that seek to bill the
                Medicare program for services or items furnished to Medicare
                beneficiaries are qualified to do so under federal and state laws. The
                process is, to an extent, a ``gatekeeper'' that prevents unqualified
                and potentially fraudulent individuals and entities from being able to
                enter and inappropriately bill Medicare. As further explained later in
                this section, CMS and its Medicare Administrative Contractors (MACs;
                hereafter occasionally referred to as ``contractors'') carefully and
                closely screen and review Medicare enrollment applicants to verify that
                they meet all applicable legal requirements.
                 We have taken various steps via regulation to outline a process for
                enrolling providers and suppliers in the Medicare program. In the April
                21, 2006 Federal Register (71 FR 20754), we published the ``Medicare
                Program; Requirements for Providers and Suppliers to Establish and
                Maintain Medicare Enrollment'' final rule that set forth certain
                requirements in 42 CFR part 424, subpart P (currently Sec. Sec.
                424.500 through 424.570) (hereinafter occasionally referenced as
                subpart P) that providers and suppliers must meet to obtain and
                maintain Medicare billing privileges. In the April 21, 2006 final rule,
                we cited sections 1102 and 1871 of the Act as general authority for our
                establishment of these requirements, which were designed for the
                efficient administration of the Medicare program.
                 Following the April 21, 2006 final rule, we published additional
                provider enrollment regulations. These were intended not only to
                clarify or strengthen certain components of the enrollment process but
                also to enable us to take further action against providers and
                suppliers: (1) Engaging (or potentially engaging) in fraudulent or
                abusive behavior; (2) presenting a risk of harm to Medicare
                beneficiaries or the Medicare Trust Funds; or (3) that are otherwise
                unqualified to furnish Medicare services or items. One such regulatory
                document was the February 2, 2011 final rule with comment period titled
                ``Medicare, Medicaid, and Children's Health Insurance Programs;
                Additional Screening Requirements, Application Fees, Temporary
                Enrollment Moratoria, Payment Suspensions and Compliance Plans for
                Providers and Suppliers'' (76 FR 5862). Implementing various provisions
                of the Affordable Care Act, this final rule with comment period did the
                following:
                 Added a new Sec. 424.514 that required submission of
                application fees by institutional providers (as that term is defined in
                Sec. 424.502) as part of the Medicare, Medicaid, and Children's Health
                Insurance Program (CHIP) provider enrollment processes.
                 Added a new Sec. 424.518 that established Medicare,
                Medicaid, and CHIP provider enrollment screening categories and
                requirements based on the CMS-assessed level of risk of fraud, waste,
                and abuse posed by a particular category of provider or supplier.
                 To further address existing provider enrollment vulnerabilities, we
                also published the following rules:
                 The December 5, 2014 final rule titled ``Medicare Program;
                Requirements for the Medicare Incentive Reward Program and Provider
                Enrollment'' (79 FR 72499).
                 The September 10, 2019 final rule with comment period
                titled ``Medicare, Medicaid, and Children's Health Insurance Programs;
                Program Integrity Enhancements to the Provider Enrollment Process'' (84
                FR 47794).
                 Both rules expanded the number and types of grounds on which CMS
                can: (1) Deny a prospective provider's or supplier's enrollment in the
                Medicare program under Sec. 424.530; or (2) revoke the Medicare
                enrollment of an existing provider or supplier under Sec. 424.535. In
                addition, the September, 10, 2019 final rule with comment period:
                 Implemented section 1866(j)(5) of the Act, which permits
                the Secretary to deny the enrollment of a Medicare, Medicaid, and CHIP
                provider or supplier if the latter has or had an affiliation with a
                provider or supplier that--(1) has uncollected debt; (2) has been or is
                subject to a payment suspension under a federal health care program;
                (3) has been or is excluded by the Office of Inspector General (OIG)
                from Medicare, Medicaid, or CHIP; or (4) has had its Medicare,
                Medicaid, or CHIP billing privileges denied or revoked.
                 Increased the maximum reenrollment bar that prohibits a
                provider or supplier from reenrolling in Medicare after it is revoked
                from 3 to 10 years, with certain exceptions.
                 Prohibited a provider or supplier from enrolling in
                Medicare for up to 3 years if its enrollment application is denied
                because the provider or supplier submitted false or misleading
                information on or with (or omitted information from) its application in
                order to enroll in Medicare.
                 We have also conducted rulemaking that established enrollment
                requirements for specific, newly-recognized types of providers and
                suppliers, such as Medicare Diabetes Prevention Program suppliers in
                2017 (82 FR 52976) and Opioid Treatment Program providers in 2019 (84
                FR 62568).
                b. Form CMS-855--Medicare Enrollment Application
                 Under Sec. 424.510, a provider or supplier must complete, sign,
                and submit to its assigned MAC the appropriate Form CMS-855 (OMB
                Control No. 0938-0685) application in order to enroll in the Medicare
                program and obtain Medicare billing privileges. The Form CMS-855, which
                can be submitted via paper or electronically through the internet-based
                Provider Enrollment, Chain, and Ownership System (PECOS) process (SORN:
                09-70-0532, Provider Enrollment, Chain, and Ownership System) captures
                information about the provider or supplier that is needed for CMS or
                its MACs to determine whether the provider or supplier meets all
                Medicare requirements. Data collected on the Form CMS-855 is carefully
                reviewed and verified by CMS or its MACs and includes, but is not
                limited to, the following:
                [[Page 39443]]
                 General identifying information (for example, legal
                business name, tax identification number).
                 Licensure and/or certification data.
                 Any final adverse actions (as that term is defined in
                Sec. 424.502) of the provider or supplier, such as felony convictions,
                OIG exclusions, or state license suspensions or revocations.
                 Practice locations and other applicable addresses of the
                provider or supplier.
                 Information regarding the provider's or supplier's owning
                and managing individuals and organizations and any final adverse
                actions those parties may have.
                 As applicable, information about the provider's or
                supplier's use of a billing agency.
                 The Form CMS-855 application is used for a number of provider
                enrollment transactions, such as the following:
                 Initial enrollment: The provider or supplier is enrolling
                in Medicare for the first time, enrolling in another MAC's
                jurisdiction, or seeking to enroll in Medicare after having previously
                been enrolled.
                 Change of ownership: The provider or supplier is reporting
                a change in its ownership.
                 Revalidation: The provider or supplier is revalidating its
                Medicare enrollment information in accordance with Sec. 424.515.
                 Reactivation: The provider or supplier is seeking to
                reactivate its Medicare billing privileges after being deactivated
                under Sec. 424.540.
                 Change of information: The provider or supplier is
                reporting a change in its existing enrollment information in accordance
                with Sec. 424.516.
                 After receiving a provider's or supplier's initial enrollment
                application, reviewing and confirming the information thereon, and
                determining whether the provider or supplier meets all applicable
                Medicare requirements, CMS or the MAC will either: (1) Approve the
                application and grant billing privileges to the provider or supplier
                (or, depending upon the provider or supplier type involved, simply
                recommend approval of the application and refer it to the state agency
                or to the CMS regional office, as applicable); or (2) deny enrollment
                under Sec. 424.530.
                 We believe, and it has been our longstanding experience, that the
                provider enrollment process is invaluable in helping to ensure that:
                (1) All potential providers and suppliers are carefully screened for
                compliance with all applicable requirements; (2) problematic providers
                and suppliers are kept out of Medicare; and (3) beneficiaries are
                protected from unqualified providers and suppliers. Given CMS'
                responsibility in preventing waste and abuse in the Medicare program,
                we believe that the safeguards that Medicare enrollment furnishes are
                needed with respect to home infusion therapy suppliers.
                2. Proposed Home Infusion Therapy Supplier Enrollment Provisions
                 There are several principal legal bases for our proposed home
                infusion therapy enrollment requirements. First, as stated previously,
                section 5012 of the Cures Act, which amended sections 1834(u),
                1861(s)(2), and 1861(iii) of the Act, established a new Medicare home
                infusion therapy benefit. Second, section 1861(iii)(3)(D)(i)(IV) of the
                Act permits the Secretary to establish requirements for qualified home
                infusion therapy suppliers that the Secretary determines appropriate.
                In doing so, the Secretary shall take into account the standards of
                care for home infusion therapy established by Medicare Advantage plans
                under Part C and in the private sector. (We interpret this latter
                proviso, however, to apply strictly to the establishment of standards
                of care as opposed to the creation of home infusion therapy supplier
                enrollment requirements.) Third, section 1866(j) of the Act provides
                specific authority with respect to the enrollment process for providers
                and suppliers. Fourth, sections 1102 and 1871 of the Act furnish
                general authority for the Secretary to prescribe regulations for the
                efficient administration of the Medicare program.
                a. Definition
                 We propose to establish a new Sec. 424.68 that would encapsulate
                the preponderance of our home infusion therapy enrollment provisions.
                In paragraph (a) thereof, we propose to define ``home infusion therapy
                supplier.'' This definition would be largely consistent with the
                definition of ``qualified home infusion therapy supplier'' in section
                1861(iii)(3)(D)(i)(IV) of the Act and the aforementioned definition of
                the same term in Sec. 486.505, though with the addition of a specific
                enrollment requirement. A home infusion therapy supplier under Sec.
                424.68, for purposes of Sec. 424.68, would mean a supplier of home
                infusion therapy that meets all of the following requirements:
                 ++ Furnishes infusion therapy to individuals with acute or chronic
                conditions requiring administration of home infusion drugs.
                 ++ Ensures the safe and effective provision and administration of
                home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
                 ++ Is accredited by an organization designated by the Secretary in
                accordance with section 1834(u)(5) of the Act.
                 ++ Is enrolled in Medicare as a home infusion therapy supplier
                consistent with the provisions of Sec. 424.68 and part 424, subpart P.
                b. General Enrollment and Payment Requirement
                 In paragraph (b), we propose that for a supplier to receive
                Medicare payment for the provision of home infusion therapy supplier
                services, the supplier must: (1) Qualify as a home infusion therapy
                supplier (as defined in Sec. 424.68); and (2) be in compliance with
                all applicable provisions of Sec. 424.68 and part 424, subpart P. This
                overarching requirement would be consistent with that in Sec. 424.505,
                which states that all providers and suppliers seeking to bill Medicare
                must enroll in Medicare and adhere to all of subpart P's enrollment
                requirements.
                c. Specific Requirements for Enrollment
                 Paragraph (c) would outline specific home infusion therapy supplier
                enrollment requirements. Some of these mirror the general enrollment
                provisions in subpart P, so we are duplicating them in Sec. 424.68 to
                clarify their applicability to home infusion therapy suppliers.
                However, the other requirements in Sec. 424.68(c) are unique to this
                supplier type.
                (1) Submission of Form CMS-855
                 In Sec. 424.68(c)(1)(i), we propose that a home infusion therapy
                supplier must complete in full and submit the Form CMS-855B application
                (``Medicare Enrollment Application: Clinics/Group Practices and Certain
                Other Suppliers'') (OMB Control No.: 0938-0685), or its electronic or
                successor application, to its applicable Medicare contractor. The Form
                CMS-855B is typically completed by suppliers other than individual
                physicians and practitioners. We thus believe that the Form CMS-855B is
                the most suitable enrollment application for home infusion therapy
                suppliers. In addition, we propose in Sec. 424.68(c)(1)(ii) that the
                home infusion therapy supplier must certify via the Form CMS-855B that
                it meets and will continue to meet the specific requirements and
                standards for enrollment described in Sec. 424.68 and part 424,
                subpart P. This is to help ensure that the home infusion therapy
                supplier fully understands its obligation
                [[Page 39444]]
                to maintain constant compliance with the requirements associated with
                home infusion therapy supplier enrollment.
                (2) Payment of Application Fee
                 As mentioned previously in our discussion of the February 2, 2011
                final rule with comment period, prospective and revalidating
                institutional providers that are submitting an enrollment application
                generally must pay the applicable application fee in accordance with
                Sec. 424.514. (For CY 2020, the fee amount is $595.) In Sec. 424.502,
                we define an institutional provider as any provider or supplier that
                submits a paper Medicare enrollment application using the Form CMS-
                855A, Form CMS-855B (not including physician and non-physician
                practitioner organizations, which are exempt from the fee requirement
                if they are enrolling as a physician or non-physician practitioner
                organization), Form CMS-855S, Form CMS-20134, or an associated
                internet-based PECOS enrollment application. Because a home infusion
                therapy supplier would be required to complete the Form CMS-855B to
                enroll in Medicare as a home infusion therapy supplier (and would not
                be enrolling as a physician/non-physician organization), we believe
                that a home infusion therapy supplier would meet the definition of an
                institutional provider under Sec. 424.502. Therefore, home infusion
                therapy suppliers would be required to pay an application fee
                consistent with Sec. 424.514, and we accordingly propose to clarify
                this fee payment requirement in new Sec. 424.68(c)(2).
                (3) Accreditation
                 In general, accreditation of applicable CMS provider and supplier
                types helps ensure that the provider or supplier meets certain minimum
                requirements for furnishing health care services. The accreditation
                process frequently includes, but is not limited to, an accreditation
                survey. Such a survey typically involves an onsite review and
                evaluation of the provider's or supplier's operations, structure, and
                procedures to determine compliance with applicable federal standards.
                Title 42, part 488, subpart L, outlines, among other things, standards
                for accreditation organizations for home infusion therapy suppliers.
                 We already indicated that the definition of ``qualified home
                infusion supplier'' in section 1861(iii)(3)(D)(i)(III) of the Act
                (codified in Sec. 486.505) requires the supplier to be accredited by
                an organization designated by the Secretary in accordance with section
                1834(u)(5) of the Act. To this end, we propose in new Sec.
                424.68(c)(3) that a home infusion therapy supplier must be currently
                and validly accredited as such by a CMS-recognized home infusion
                therapy supplier accreditation organization in order to enroll and
                remain enrolled in Medicare.
                (4) Home Infusion Therapy Supplier Standards
                 Part 486, subpart I, outlines certain standards to which home
                infusion therapy suppliers must adhere. For instance, Sec. 486.520
                identifies required components of a home infusion therapy supplier's
                plan of care; one such component is that all of the home infusion
                therapy supplier's patients must have a plan of care established by a
                physician that prescribes the type, amount, and duration of the home
                infusion therapy services to be furnished. Section 486.525, meanwhile,
                lists specific services that the home infusion therapy supplier must
                furnish.
                 Additional home infusion therapy supplier provisions are contained
                in part 414, subpart P. For purposes of our proposed enrollment
                requirements, we believe the most pertinent of these are--
                 Section 414.1505, which outlines several requirements that
                must be met for home infusion therapy services to be paid.
                 Section 414.1515, which identifies plan of care
                requirements supplemental to those in Sec. 486.520(b).
                 The aforementioned provisions in parts 486 and 414 reflect
                important quality standards and payment safeguards that should not, in
                our view, be entirely separate from our enrollment requirements.
                Indeed, these provisions, like our enrollment process, help ensure that
                the home infusion therapy supplier is qualified to furnish such
                services. Consequently, we propose the following:
                 In new Sec. 424.68(c)(4), we propose that in order to
                enroll and maintain enrollment as a home infusion therapy supplier, the
                latter must be compliant with Sec. 414.1515 and all provisions of 42
                CFR part 486, subpart I.
                 In Sec. 414.1505, we propose to add a new paragraph (c)
                stating that, along with the requirements for home infusion therapy
                payment listed in paragraphs Sec. 414.1505(a) and (b), the home
                infusion therapy supplier must also be enrolled in Medicare consistent
                with the provisions of Sec. 424.68 and part 424, subpart P.
                (5) Home Infusion Therapy Suppliers: Categorical Risk Designation
                 We previously referenced Sec. 424.518, which outlines screening
                categories and requirements based on a CMS assessment of the level of
                risk of fraud, waste, and abuse posed by a particular category of
                provider or supplier. In general, the higher the level of risk that a
                certain provider or supplier type poses, the greater the level of
                scrutiny with which CMS screens and reviews providers or suppliers
                within that category.
                 There are three categories of screening in Sec. 424.518: Limited,
                moderate, and high. Irrespective of which category a provider or
                supplier type falls within, the MAC performs the following screening
                functions upon receipt of an initial enrollment application, a
                revalidation application, or an application to add a new practice
                location:
                 Verifies that the provider or supplier meets all
                applicable federal regulations and state requirements for their
                provider or supplier type.
                 Conducts state license verifications.
                 Conducts database checks on a pre- and post-enrollment
                basis to ensure that providers and suppliers continue to meet the
                enrollment criteria for their provider or supplier type.
                 Providers and suppliers at the moderate and high categorical risk
                levels, however, must also undergo a site visit. Furthermore, for those
                in the high categorical risk level, the MAC performs two additional
                functions under Sec. 424.518(c)(2). First, the MAC requires the
                submission of a set of fingerprints for a national background check
                from all individuals who maintain a 5 percent or greater direct or
                indirect ownership interest in the provider or supplier. Second, it
                conducts a fingerprint-based criminal history record check of the
                Federal Bureau of Investigation's (FBI) Integrated Automated
                Fingerprint Identification System on all individuals who maintain a 5
                percent or greater direct or indirect ownership interest in the
                provider or supplier. These additional verification activities are
                intended to correspond to the heightened risk involved with such
                provider or supplier type.
                 We propose to add home infusion therapy suppliers to the types of
                providers and suppliers that are subject to the limited risk level of
                categorical screening. We have no recent evidence to suggest that home
                infusion therapy suppliers (as a supplier type) pose an enhanced threat
                of fraud, waste, or abuse that would warrant their placement in the
                moderate or high screening level; more precisely, our review of home
                infusion therapy services furnished by other existing provider and
                supplier types generally
                [[Page 39445]]
                has not uncovered aberrant billing practices or significant fraud,
                waste, or abuse.
                 Our specific regulatory revisions would involve: (1) Redesignating
                existing Sec. 424.518(a)(1)(vii) through (xvi) as, respectively, Sec.
                424.518(a)(1)(viii) through (xvii); (2) including home infusion therapy
                suppliers in revised Sec. 424.518(a)(vii); and (3) stating in new
                Sec. 424.68(c)(5) that home infusion therapy suppliers must
                successfully complete the limited categorical risk level of screening
                under Sec. 424.518.
                d. Denial of Enrollment and Appeals
                 We propose in new Sec. 424.68(d)(1)(i) and (ii), respectively,
                that CMS may deny a home infusion therapy supplier's enrollment
                application on either of the following grounds:
                 The home infusion therapy supplier does not meet all of
                the requirements for enrollment outlined in Sec. 424.68 and in part
                424, subpart P of this title; or
                 Any of the reasons for denial of a prospective provider's
                or supplier's enrollment application in Sec. 424.530 applies.
                 In new Sec. 424.68(d)(2), we are proposing that a home infusion
                therapy supplier may appeal the denial of its enrollment application
                under 42 CFR part 498.
                 Section 424.68(d)(1)(i) is needed so CMS can ensure that
                unqualified home infusion therapy suppliers are kept out of the
                Medicare program. Concerning paragraphs (d)(1)(ii) and (2), the
                requirements in part 424, subpart P and the appeals provisions in part
                498 would apply to home infusion therapy suppliers to the same extent
                as they would to all other providers and suppliers. Thus, we believe it
                is appropriate to include paragraphs (d)(1)(ii) and (2) within Sec.
                424.68.
                e. Continued Compliance, Standards, and Reasons for Revocation
                 For reasons identical to those behind Sec. 424.68(c), we propose
                several provisions in new Sec. 424.68(e).
                 In paragraph (e)(1), we propose to state that, upon and after
                enrollment, a home infusion therapy supplier--
                 Must remain currently and validly accredited as described
                in Sec. 424.68(c)(3); and
                 Remains subject to, and must remain in full compliance
                with, all of the provisions of--
                 ++ Section 424.68;
                 ++ Part 424, subpart P;
                 ++ Section 414.1515; and
                 ++ Part 486, subpart I.
                 In paragraph (e)(2), we are proposing that CMS may revoke a home
                infusion therapy supplier's enrollment if--
                 The supplier does not meet the accreditation requirements
                as described in Sec. 424.68(c)(3);
                 The supplier does not comply with all of the provisions
                of--
                 ++ Section 424.68;
                 ++ Part 424, subpart P;
                 ++ Section 414.1515; and
                 ++ Part 486, subpart I; or
                 Any of the revocation reasons in Sec. 424.535 applies.
                 In new paragraph (e)(3), we propose that a home infusion therapy
                supplier may appeal the revocation of its enrollment under part 498.
                f. Effective and Retrospective Date of Home Infusion Therapy Supplier
                Billing Privileges
                 Section 424.520 outlines the effective date of billing privileges
                for certain provider and supplier types that are eligible to enroll in
                Medicare. Section 424.520(d) sets forth the applicable effective date
                for physicians, non-physician practitioners, physician and non-
                physician practitioner organizations, ambulance suppliers, and opioid
                treatment programs. This effective date is the later of: (1) The date
                of filing of a Medicare enrollment application that was subsequently
                approved by a Medicare contractor; or (2) the date that the supplier
                first began furnishing services at a new practice location. In a
                similar vein, Sec. 424.521(a) states that physicians, non-physician
                practitioners, physician and non-physician practitioner organizations,
                ambulance suppliers, and opioid treatment programs may retrospectively
                bill for services when the supplier has met all program requirements
                (including state licensure requirements), and services were provided at
                the enrolled practice location for up to--
                 Thirty days prior to their effective date if circumstances
                precluded enrollment in advance of providing services to Medicare
                beneficiaries; or
                 Ninety days prior to their effective date if a
                Presidentially-declared disaster under the Robert T. Stafford Disaster
                Relief and Emergency Assistance Act, 42 U.S.C. 5121 through 5206
                (Stafford Act) precluded enrollment in advance of providing services to
                Medicare beneficiaries.
                 To clarify the effective date of billing privileges for home
                infusion therapy suppliers and to account for circumstances that could
                prevent a home infusion therapy supplier's enrollment prior to the
                furnishing of Medicare services, we propose to include newly enrolling
                home infusion therapy suppliers within the scope of both Sec. Sec.
                424.520(d) and 424.521(a). We believe that the effective and
                retrospective billing dates addressed therein achieve a proper balance
                between the need for the prompt provision of home infusion therapy
                services and the importance of ensuring that each prospective home
                infusion therapy enrollee is carefully and closely screened for
                compliance with all applicable requirements.
                VI. Collection of Information Requirements
                 Under the Paperwork Reduction Act of 1995, 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. In
                order to fairly evaluate whether an information collection should be
                approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
                of 1995 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.
                 We are soliciting public comment on each of these issues for the
                following sections of this document that contain information collection
                requirements (ICRs):
                 The following discusses the information collection requirements
                associated with Sec. 424.68. Specifically, this section discusses our
                proposed burden estimates for the enrollment of home infusion therapy
                suppliers as well as the PRA exemption we are claiming for the appeals
                process.
                1. Enrollment
                 As discussed in section V.B.2. of this proposed rule, home infusion
                therapy suppliers would be required to enroll in Medicare via the paper
                or internet-based version of the Form CMS-855B (``Medicare Enrollment
                Application: Clinics/Group Practices and Certain Other Suppliers'')
                (OMB Control Number: 0938-0685), or its electronic or successor
                application, and pay the application fee in accordance with Sec.
                424.514.
                 Using existing accreditation statistics and our internal data, we
                generally estimate that: (1) There are about 600 home infusion therapy
                suppliers that would be eligible for Medicare enrollment under our
                proposed
                [[Page 39446]]
                provisions, all of whom would enroll in the initial year of our
                requirements; and (2) 50 home infusion therapy suppliers would annually
                enroll in Year 2 and in Year 3. This results in a total of 700 home
                infusion therapy suppliers enrolling over the next 3 years.
                 According to the most recent wage data provided by the Bureau of
                Labor Statistics (BLS) for May 2019 (see http://www.bls.gov/oes/current/oes_nat.htm), the mean hourly wages for the following
                categories are:
                [GRAPHIC] [TIFF OMITTED] TP30JN20.105
                 Consistent with Form CMS-855B projections made in recent rulemaking
                efforts, it would take each home infusion therapy supplier an average
                of 2.5 hours to obtain and furnish the information on the Form CMS-
                855B. Per our experience, the home infusion therapy supplier's medical
                secretary would be responsible for securing and reporting data on the
                Form CMS-855B and that this task takes approximately 2 hours.
                Additionally, the form would be reviewed and signed by a health
                diagnosing and treating practitioner of the home infusion therapy
                supplier, a process we estimate takes 30 minutes. Therefore, we project
                a first-year burden of 1,500 hours (600 suppliers x 2.5 hrs) at a cost
                of $73,500 (600 suppliers x ((2 hrs x $36.62/hr) + (0.5 hrs x $98.52/
                hr)), a second-year burden of 125 hours (50 suppliers x 2.5 hrs) at a
                cost of $6,125 (50 suppliers x ((2 hrs x $36.62/hr) + (0.5 hrs x
                $98.52/hr)), and a third-year burden of 125 hours (50 suppliers x 2.5
                hrs) at a cost of $6,125 (50 suppliers x ((2 hrs x $36.62/hr) + (0.5
                hrs x $98.52/hr)). In aggregate, we estimate a burden of 1,750 hours
                (1,500 hrs + 125 hrs + 125 hrs) at a cost of $85,750). When averaged
                over the typical 3-year OMB approval period, we estimate an annual
                burden of 583 hours (1,750 hrs/3) at a cost of $28,583 ($85,750/3).
                 We welcome comments on all of these estimates.
                2. Appeals
                 As stated earlier in the preamble, newly proposed Sec.
                424.68(d)(2) and (e)(3) state that a home infusion therapy supplier may
                appeal the denial or revocation of its enrollment application under 42
                CFR part 498. While there are information collection requirements
                associated with the appeals process, we believe they are exempt from
                the PRA. In accordance with the implementing regulations of the PRA at
                5 CFR 1320.4(a)(2), the information collection requirements associated
                with the appeals process are subsequent to an administrative action;
                that is, the denial or revocation of a home infusion therapy supplier
                enrollment application. Therefore, we have not developed burden
                estimates. We also note our belief that any costs associated with home
                infusion therapy supplier appeals would, in any event, be de minimis;
                this is because we would anticipate, based on past experience,
                comparatively few denials and revocations of home infusion therapy
                supplier enrollments.
                VII. Regulatory Impact Analysis
                A. Statement of Need
                1. Home Health Prospective Payment System (HH PPS)
                 Section 1895(b)(1) of the Act requires the Secretary to establish a
                HH PPS for all costs of home health services paid under Medicare. In
                addition, section 1895(b) of the Act requires: (1) The computation of a
                standard prospective payment amount include all costs for home health
                services covered and paid for on a reasonable cost basis and that such
                amounts be initially based on the most recent audited cost report data
                available to the Secretary; (2) the prospective payment amount under
                the HH PPS to be an appropriate unit of service based on the number,
                type, and duration of visits provided within that unit; and (3) the
                standardized prospective payment amount be adjusted to account for the
                effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B)
                of the Act addresses the annual update to the standard prospective
                payment amounts by the HH applicable percentage increase. Section
                1895(b)(4) of the Act governs the payment computation. Sections
                1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act requires the standard
                prospective payment amount to be adjusted for case-mix and geographic
                differences in wage levels. Section 1895(b)(4)(B) of the Act requires
                the establishment of appropriate case-mix adjustment factors for
                significant variation in costs among different units of services.
                Lastly, section 1895(b)(4)(C) of the Act requires the establishment of
                wage adjustment factors that reflect the relative level of wages, and
                wage-related costs applicable to home health services furnished in a
                geographic area compared to the applicable national average level.
                 Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with
                the authority to implement adjustments to the standard prospective
                payment amount (or amounts) for subsequent years to eliminate the
                effect of changes in aggregate payments during a previous year or years
                that were the result of changes in the coding or classification of
                different units of services that do not reflect real changes in case-
                mix. Section 1895(b)(5) of the Act provides the Secretary with the
                option to make changes to the payment amount otherwise paid in the case
                of outliers because of unusual variations in the type or amount of
                medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires
                HHAs to submit data for purposes of measuring health care quality, and
                links the quality data submission to the annual applicable percentage
                increase. Section 50208 of the BBA of 2018 (Pub. L. 115-123) requires
                the Secretary to implement a new methodology used to determine rural
                add-on payments for CYs 2019 through 2022.
                 Sections 1895(b)(2) and 1895(b)(3)(A) of the Act, as amended by
                section 51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively,
                required the Secretary to implement a 30-day unit of service, for 30-
                day periods beginning on and after January 1, 2020. The HH PPS wage
                index utilizes the wage adjustment factors used by the Secretary for
                purposes of Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act for
                hospital wage adjustments. In this proposed rule,
                [[Page 39447]]
                we are proposing to adopt the new OMB delineations and apply a 5
                percent cap only in CY 2021 on any decrease in a geographic area's wage
                index value from the wage index value from the prior calendar year.
                This transition would allow the effects of our proposed adoption of the
                revised CBSA delineations to be phased in over 2 years, where the
                estimated reduction in a geographic area's wage index would be capped
                at 5 percent in CY 2021 (that is, no cap would be applied to the
                reduction in the wage index for the second year (CY 2022)).
                B. Overall Impact
                 We have examined the impacts of this 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 Social Security Act,
                section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
                1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
                1999), the Congressional Review Act (5 U.S.C. 801(a)(1)(B)(i)), 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. Given that, we note
                the following costs associated with the provisions of this proposed
                rule:
                 A regulatory impact analysis (RIA) must be prepared for major rules
                with economically significant effects ($100 million or more in any 1
                year). The net transfer impact related to the changes in payments under
                the HH PPS for CY 2021 is estimated to be $540 million (2.6 percent).
                Therefore, we estimate that this rule is ``economically significant''
                as measured by the $100 million threshold, and hence also a major rule
                under the Congressional Review Act. Accordingly, we have prepared a
                Regulatory Impact Analysis that presents our best estimate of the costs
                and benefits of this rule.
                C. Anticipated Effects
                1. HH PPS
                 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, nonprofit organizations, and small
                governmental jurisdictions. Most hospitals and most other providers and
                suppliers are small entities, either by nonprofit status or by having
                revenues of less than $7.5 million to $38.5 million in any one year.
                For the purposes of the RFA, we estimate that almost all HHAs and home
                infusion therapy suppliers are small entities as that term is used in
                the RFA. Individuals and states are not included in the definition of a
                small entity. The economic impact assessment is based on estimated
                Medicare payments (revenues) and HHS's practice in interpreting the RFA
                is to consider effects economically ``significant'' only if greater
                than 5 percent of providers reach a threshold of 3 to 5 percent or more
                of total revenue or total costs. The majority of HHAs' visits are
                Medicare paid visits and therefore the majority of HHAs' revenue
                consists of Medicare payments. Based on our analysis, we conclude that
                the policies proposed in this rule would not result in an estimated
                total impact of 3 to 5 percent or more on Medicare revenue for greater
                than 5 percent of HHAs. Therefore, the Secretary has determined that
                this HH PPS proposed rule would have a not have significant economic
                impact on a substantial number of small entities.
                 In addition, section 1102(b) of the Act requires us to prepare a
                RIA 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 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 is not applicable to hospitals. Therefore, the
                Secretary has determined this final rule will not have a significant
                economic impact on the operations 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 2020, that
                threshold is approximately $156 million. This rule is not anticipated
                to have an effect on State, local, or tribal governments, in the
                aggregate, or on the private sector of $156 million or more.
                 Executive Order 13132 establishes certain requirements that an
                agency must meet when it promulgates 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. We have reviewed this proposed rule under these criteria
                of Executive Order 13132, and have determined that it will not impose
                substantial direct costs on state or local governments.
                2. HH QRP
                 We are not proposing any changes to the HH QRP. Therefore, we are
                not providing any estimated impacts.
                3. Change to the CoP OASIS Requirement
                 No impact was assessed for this provision in the January 13, 2017
                final rule titled ``Medicare and Medicaid Program: Conditions of
                Participation for Home Health Agencies (82 FR 4504). Therefore, we do
                not believe that there are any burden reductions to be assessed when
                removing this requirement.
                4. Payment for Home Infusion Therapy Services
                 In the CY 2020 HH PPS final rule with comment period, we estimated
                that the implementation of the permanent home infusion therapy benefit
                would result in a 3.6 percent decrease ($2 million) in payments to home
                infusion therapy suppliers in CY 2021 (84 FR 60639). This decrease
                reflects the exclusion of statutorily-excluded drugs and biologicals,
                and is representative of a wage-adjusted 4-hour payment rate, compared
                to a wage-adjusted 5-hour payment rate.
                [[Page 39448]]
                 There are no new proposals in this rule related to payments for
                home infusion therapy services in CY 202l. However, we estimate that
                the impact of updating the payment rates for home infusion therapy
                services for CY 2021, based on the PFS amounts for CY 2021, is no more
                than a 1 to 2 percent increase/decrease in payments ($1 million or
                less). The CY 2021 proposed PFS amounts were not available at the time
                of rulemaking; therefore, this estimate is based on the impact between
                the CY 2019 PFS amounts compared to the CY 2020 PFS amounts outlined in
                the CY 2020 HH PPS final rule with comment period (84 FR 60639).
                5. Home Infusion Therapy Supplier Requirements
                 As stated previously, we are proposing that home infusion therapy
                suppliers be required to enroll in Medicare and pay an application fee
                at the time of enrollment in accordance with Sec. 424.514.
                 The application fees for each of the past 3 calendar years were or
                are $569 (CY 2018), $586, (CY 2019), and $595 (CY 2020). Consistent
                with Sec. 424.514, the differing fee amounts are predicated on
                changes/increases in the Consumer Price Index (CPI) for all urban
                consumers (all items; United State city average, CPI-U) for the 12-
                month period ending on June 30 of the previous year. Although we cannot
                predict future changes to the CPI, the fee amounts between 2018 and
                2020 increased by an average of $13 per year. We believe this is a
                reasonable barometer with which to establish estimates (strictly for
                purposes of the proposed rule) of the fee amounts in the first 3 CYs of
                this rule (that is, 2021, 2022, and 2023). Thus, we project a fee
                amount of $608 in 2021, $621 for 2022, and $634 for 2023.
                 Applying these prospective fee amounts to the number of projected
                applicants in the rule's first 3 years, we estimate a total application
                fee cost to enrollees of $364,800 (or 600 x $608) in the first year,
                $31,050 (or 50 x $621) in the second year, and $31,700 (or 50 x $634)
                in the third year. (This constitutes an average annual figure over the
                first 3 years of this proposed requirement of $142,517). As referenced
                in Table 1 of this proposed rule, this would represent a transfer from
                home infusion therapy suppliers to the federal government.
                 As noted in Table 1 and section VI.B.1. of this proposed rule, the
                estimated average annual burden associated with home infusion therapy
                supplier enrollment over the 3-year OMB approval period is 583 hours at
                a cost of $28,583.
                6. Regulatory Review Cost Estimation
                 If regulations impose administrative costs on private entities,
                such as the time needed to read and interpret this final rule, we must
                estimate the cost associated with regulatory review. Due to the
                uncertainty involved with accurately quantifying the number of entities
                that would review the rule, we assume that the total number of unique
                reviewers of this year's proposed rule would be the similar to the
                number of commenters on last 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 this 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 believe that the
                number of past commenters would be a fair estimate of the number of
                reviewers of this rule. We welcome any comments on the approach in
                estimating the number of entities which would review this proposed
                rule. We also recognize that different types of entities are in many
                cases affected by mutually exclusive sections of this proposed rule,
                and therefore for the purposes of our estimate we assume that each
                reviewer reads approximately 50 percent of the rule. We seek comments
                on this assumption. 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 of 250 words per minute, we estimate that it
                would take approximately 1.3 hours for the staff to review half of this
                proposed rule, which consists of approximately 39,000 words. For each
                HHA that reviews the rule, the estimated cost is $142.17 (1.3 hours x
                $109.36). Therefore, we estimate that the total cost of reviewing this
                proposed rule is $79,614 ($142.17 x 560 reviewers). For purposes of
                this estimate, the number of anticipated reviewers in this year's rule
                is equivalent to the number of commenters on the CY 2020 HH PPS
                proposed rule.
                D. Detailed Economic Analysis
                 This rule proposes updates to Medicare payments under the HH PPS
                for CY 2021. The impact analysis of this proposed rule presents the
                estimated expenditure effects of policy changes proposed in this rule.
                We use the latest data and best analysis available, but we do not make
                adjustments for future changes in such variables as number of visits or
                case mix. This analysis incorporates the latest estimates of growth in
                service use and payments under the Medicare HH benefit, based primarily
                on Medicare claims data for episodes ending on or before December 31,
                2019. We note that certain events may combine to limit the scope or
                accuracy of our impact analysis, because such an analysis is future-
                oriented and, thus, susceptible to errors resulting from other changes
                in the impact time period assessed. Some examples of such possible
                events are newly-legislated general Medicare program funding changes
                made by the Congress, or changes specifically related to HHAs. In
                addition, changes to the Medicare program may continue to be made as a
                result of the Affordable Care Act, or new statutory provisions.
                Although these changes may not be specific to the HH PPS, the nature of
                the Medicare program is such that the changes may interact, and the
                complexity of the interaction of these changes could make it difficult
                to predict accurately the full scope of the impact upon HHAs.
                 Table 17 represents how HHA revenues are likely to be affected by
                the policy changes proposed in this rule for CY 2021. For this
                analysis, we used an analytic file with linked CY 2019 OASIS
                assessments and HH claims data for dates of service that ended on or
                before December 31, 2019. The first column of Table 17 classifies HHAs
                according to a number of characteristics including provider type,
                geographic region, and urban and rural locations. The second column
                shows the number of facilities in the impact analysis. The third column
                shows the payment effects of updating to the CY 2021 wage index. The
                fourth column shows the effects of moving from the old OMB delineations
                to the new OMB delineations with a 5 percent cap on wage index
                decreases. The fifth column shows the payment effects of the CY 2021
                rural add-on payment provision in statute. The sixth column shows the
                payment effects of the CY 2021 home health payment update percentage.
                And the last column shows the combined effects of all the policies
                proposed in this rule.
                 Overall, it is projected that aggregate payments in CY 2021 would
                increase by 2.6 percent. As illustrated in Table 17, the combined
                effects of all of the changes vary by specific types of providers and
                by location. We note that some individual HHAs within the same group
                may experience different impacts on payments than others due to the
                distributional impact of the CY 2021 wage index, the percentage of
                total HH PPS payments that were subject to the low-utilization payment
                adjustment
                [[Page 39449]]
                (LUPA) or paid as outlier payments, and the degree of Medicare
                utilization.
                BILLING CODE 4120-01-P
                [GRAPHIC] [TIFF OMITTED] TP30JN20.106
                [[Page 39450]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.107
                BILLING CODE 4120-01-C
                E. Alternatives Considered
                 For the CY 2021 Home Health Prospective Payment Rate Update, we
                considered alternatives to the proposals articulated in section III.D
                of this proposed rule. We considered not adopting the OMB delineations.
                However, we have historically adopted the latest OMB delineations as we
                believe that implementing the new OMB delineations would result in wage
                index values being more representative of the actual costs of labor in
                a given area. Additionally, we considered not implementing the 1-year 5
                percent cap on wage index decreases. While there are some minimal
                impacts on certain HHAs as a result of this 5 percent cap proposal as
                shown in the regulatory impact analysis of this proposed rule, we
                decided that the 5 percent cap was a better option for the transition
                because it would mitigate potential negative impacts from the
                transition to the new OMB delineations and allow providers the
                opportunity to adjust to the changes in their wage index values
                gradually.
                F. Accounting Statement and Tables
                 As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 18, we have prepared an accounting statement showing
                the classification of the transfers and benefits associated with the CY
                2021 HH PPS provisions of this rule.
                [[Page 39451]]
                [GRAPHIC] [TIFF OMITTED] TP30JN20.108
                G. Regulatory Reform Analysis Under E.O. 13771
                 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. It
                has been determined that this proposed rule is an action that primarily
                results in transfers and does not impose more than de minimis costs as
                described previously and thus is not a regulatory or deregulatory
                action for the purposes of Executive Order 13771.
                H. Conclusion
                 In conclusion, we estimate that the provisions in this proposed
                rule would result in an estimated net increase in HH payments of 2.6
                percent for CY 2021 ($540 million). The $540 million increase in
                estimated payments for CY 2021 reflects the effects of the CY 2021 home
                health payment update percentage of 2.7 percent ($560 million increase)
                and an estimated -0.1 percent decrease in payments due to the rural
                add-on percentages mandated by the Bipartisan Budget Act of 2018 for CY
                2021 ($20 million decrease).
                 This analysis, together with the remainder of this preamble,
                provides an initial Regulatory Flexibility Analysis.
                List of Subjects
                42 CFR Part 409
                 Health facilities, Medicare.
                42 CFR Part 414
                 Administrative practice and procedure, Health facilities, Health
                professions, Kidney diseases, Medicare, Reporting and recordkeeping
                requirements.
                42 CFR Part 424
                 Emergency medical centers, Health facilities, Health professions,
                Medicare, Medicare, Reporting and recordkeeping requirements.
                42 CFR Part 484
                 Health facilities, Health professions, Medicare, and Reporting and
                recordkeeping requirements.
                 For the reasons set forth in the preamble, the Centers for Medicare
                & Medicaid Services proposes to amend 42 CFR chapter IV as follows:
                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.
                0
                2. Section 409.43 is amended by revising paragraphs (a) introductory
                text, (a)(1), and (3) to read as follows:
                Sec. 409.43 Plan of care requirements.
                 (a) Contents. An individualized plan of care must be established
                and periodically reviewed by the certifying physician or allowed
                practitioner.
                 (1) The HHA must be acting upon a plan of care that meets the
                requirements of this section for HHA services to be covered.
                * * * * *
                 (3)(i) The plan of care must include all of the following:
                 (A) The identification of the responsible discipline(s) and the
                frequency and duration of all visits as well as those items listed in
                Sec. 484.60(a) of this chapter that establish the need for such
                services.
                 (B) Any provision of remote patient monitoring or other services
                furnished via a telecommunications system and such services must be
                tied to the patient-specific needs as identified in the comprehensive
                assessment, cannot substitute for a home visit ordered as part of the
                plan of care, and cannot be considered a home visit for the purposes of
                patient eligibility or payment.
                 (C) A description of how the use of such technology will help to
                achieve the goals outlined on the plan of care.
                 (ii) All care provided must be in accordance with the plan of care.
                * * * * *
                0
                3. Section 409.46 is amended by revising paragraph (e) to read as
                follows:
                Sec. 409.46 Allowable administrative costs.
                * * * * *
                 (e) Telecommunications technology. Telecommunications technology,
                as indicated on the plan of care, can include: Remote patient
                monitoring, defined as the collection of physiologic data (for example,
                ECG, blood pressure, glucose monitoring) digitally stored and/or
                transmitted by the patient or caregiver or both to the home health
                agency; teletypewriter (TTY) technology; and 2-way audio-video
                telecommunications technology that allows for real-time interaction
                between the patient and clinician. The costs of any equipment, set-up,
                and service related to the technology are allowable only as
                administrative costs. Visits to a beneficiary's home for the sole
                purpose of supplying, connecting, or training the patient on the
                technology, without the provision of a skilled service, are not
                separately billable.
                0
                4. Section 409.49 is amended by adding paragraph (h) to read as
                follows:
                Sec. 409.49 Excluded services.
                * * * * *
                 (h) Services covered under the Home Infusion Therapy benefit.
                Services that are covered under the home infusion therapy benefit as
                outlined at Sec. 486.525 of this chapter, including any home infusion
                therapy services furnished to a Medicare beneficiary that is under a
                home health plan of care, are excluded from coverage under the Medicare
                home health benefit. Excluded home infusion therapy services pertain to
                the items and services for the provision of home infusion drugs, as
                defined at Sec. 486.505 of this chapter. Services for the provision of
                drugs and biologicals not covered under this definition may continue to
                be provided under the Medicare home health benefit.
                PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
                0
                5. The authority citation for part 414 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
                0
                6. Section 414.1505 is amended by adding paragraph (c) to read as
                follows:
                Sec. 414.1505 Requirement for payment.
                * * * * *
                [[Page 39452]]
                 (c) The home infusion therapy supplier must be enrolled in Medicare
                consistent with the provisions of Sec. 424.68 and part 424, subpart P
                of this chapter.
                PART 424--CONDITIONS FOR MEDICARE PAYMENT
                0
                7. The authority citation for part 424 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                8. Section 424.68 is added to subpart E to read as follows:
                Sec. 424.68 Enrollment requirements for home infusion therapy
                suppliers.
                 (a) Definition. For purposes of this section, a home infusion
                therapy supplier means a supplier of home infusion therapy that meets
                all of the following requirements:
                 (1) Furnishes infusion therapy to individuals with acute or chronic
                conditions requiring administration of home infusion drugs.
                 (2) Ensures the safe and effective provision and administration of
                home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
                 (3) Is accredited by an organization designated by the Secretary in
                accordance with section 1834(u)(5) of the Act.
                 (4) Is enrolled in Medicare as a home infusion therapy supplier
                consistent with the provisions of this section and of part 424, subpart
                P of this chapter.
                 (b) General requirement. For a supplier to receive Medicare payment
                for the provision of home infusion therapy supplier services, the
                supplier must qualify as a home infusion therapy supplier (as defined
                in this section) and be in compliance with all applicable provisions of
                this section and of part 424, subpart P of this chapter.
                 (c) Specific requirements for enrollment. To enroll in the Medicare
                program as a home infusion therapy supplier, a home infusion therapy
                supplier must meet all of the following requirements:
                 (1)(i) Fully complete and submit the Form CMS-855B application (or
                its electronic or successor application) to its applicable Medicare
                contractor.
                 (ii) Certify via the Form CMS-855B that the home infusion therapy
                supplier meets and will continue to meet the specific requirements and
                standards for enrollment described in this section and in part 424,
                subpart P of this chapter.
                 (2) Comply with the application fee requirements in Sec. 424.514.
                 (3) Be currently and validly accredited as a home infusion therapy
                supplier by a CMS-recognized home infusion therapy supplier
                accreditation organization.
                 (4) Comply with Sec. 414.1515 of this chapter and all provisions
                of part 486, subpart I of this chapter.
                 (5) Successfully complete the limited categorical risk level of
                screening under Sec. 424.518 of this title.
                 (d) Denial of enrollment. (1) Enrollment denial by CMS. CMS may
                deny a supplier's enrollment application as a home infusion therapy
                supplier on either of the following grounds:
                 (i) The supplier does not meet all of the requirements for
                enrollment outlined in Sec. 424.68 and in part 424, subpart P of this
                chapter.
                 (ii) Any of the applicable denial reasons in Sec. 424.530.
                 (2) Appeal of an enrollment denial. A supplier may appeal the
                denial of its enrollment application as a home infusion therapy
                supplier under part 498 of this chapter.
                 (e) Continued compliance, standards, and reasons for revocation.
                (1) Upon and after enrollment, a home infusion therapy supplier--
                 (i) Must remain currently and validly accredited as described in
                paragraph (c)(3) of this section.
                 (ii) Remains subject to, and must remain in full compliance with,
                all of the provisions of--
                 (A) This section;
                 (B) Part 424, subpart P of this chapter;
                 (C) Section 414.1515 of this chapter; and
                 (D) Part 486, subpart I of this chapter.
                 (2) CMS may revoke a home infusion therapy supplier's enrollment on
                any of the following grounds:
                 (i) The supplier does not meet the accreditation requirements as
                described in paragraph (c)(3) of this section.
                 (ii) The supplier does not comply with all of the provisions of--
                 (A) This section;
                 (B) Part 424, subpart P of this chapter;
                 (C) Section 414.1515 of this chapter; and
                 (D) Part 486, subpart I of this chapter; or
                 (iii) Any of the revocation reasons in Sec. 424.535 applies.
                 (3) A home infusion therapy supplier may appeal the revocation of
                its enrollment under part 498 of this chapter.
                0
                9. Section 424.518 is amended by redesignating paragraphs (a)(1)(vii)
                through (xvi) as paragraphs (a)(1)(viii) through (xvii) and adding a
                new paragraph (a)(1)(vii) to read as follows:
                Sec. 424.518 Screening levels for Medicare providers and suppliers.
                * * * * *
                 (a) * * *
                 (1) * * *
                 (vii) Home infusion therapy suppliers.
                * * * * *
                0
                10. Section 424.520 is amended by revising paragraph (d) introductory
                text to read as follows:
                Sec. 424.520 Effective date of Medicare billing privileges.
                * * * * *
                 (d) Physicians, non-physician practitioners, physician and non-
                physician practitioner organizations, ambulance suppliers, opioid
                treatment programs, and home infusion therapy suppliers. The effective
                date for billing privileges for physicians, non-physician
                practitioners, physician and non-physician practitioner organizations,
                ambulance suppliers, opioid treatment programs, and home infusion
                therapy suppliers is the later of--
                * * * * *
                0
                11. Section 424.521 is amended by revising the section heading and
                paragraph (a) introductory text to read as follows:
                Sec. 424.521 Request for payment by physicians, non-physician
                practitioners, physician and non-physician organizations, ambulance
                suppliers, opioid treatment programs, and home infusion therapy
                suppliers.
                 (a) Physicians, non-physician practitioners, physician and non-
                physician practitioner organizations, ambulance suppliers, opioid
                treatment programs, and home infusion therapy suppliers may
                retrospectively bill for services when the physician, non-physician
                practitioner, physician or non-physician organization, ambulance
                supplier, opioid treatment program, or home infusion therapy supplier
                has met all program requirements, including State licensure
                requirements, and services were provided at the enrolled practice
                location for up to --
                * * * * *
                PART 484--HOME HEALTH SERVICES
                0
                12. The authority citation for part 484 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                Sec. 484.45 [Amended]
                0
                13. Section 484.45 is amended by--
                0
                a. Removing paragraph (c)(2); and
                0
                b. Redesignating paragraphs (c)(3) and (4) as paragraphs (c)(2) and
                (3), respectively.
                [[Page 39453]]
                 Dated: June 12, 2020.
                Seema Verma,
                Administrator, Centers for Medicare and Medicaid Services.
                 Dated: June 19, 2020.
                Alex M. Azar II,
                Secretary, Department of Health and Human Services.
                [FR Doc. 2020-13792 Filed 6-25-20; 4:15 pm]
                 BILLING CODE 4120-01-P
                

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