[Federal Register Volume 84, Number 217 (Friday, November 8, 2019)]
[Rules and Regulations]
[Pages 60478-60646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24026]
[[Page 60477]]
Vol. 84
Friday,
No. 217
November 8, 2019
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 409, 414, 484, et al.
Medicare and Medicaid Programs; CY 2020 Home Health Prospective
Payment System Rate Update; Home Health Value-Based Purchasing Model;
Home Health Quality Reporting Requirements; and Home Infusion Therapy
Requirements; Final Rule
Federal Register / Vol. 84 , No. 217 / Friday, November 8, 2019 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409, 414, 484, and 486
[CMS-1711-FC]
RIN 0938-AT68
Medicare and Medicaid Programs; CY 2020 Home Health Prospective
Payment System Rate Update; Home Health Value-Based Purchasing Model;
Home Health Quality Reporting Requirements; and Home Infusion Therapy
Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
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SUMMARY: This final rule with comment period updates the home health
prospective payment system (HH PPS) payment rates and wage index for CY
2020; implements the Patient-Driven Groupings Model (PDGM), a revised
case-mix adjustment methodology, for home health services beginning on
or after January 1, 2020. This final rule with comment period also
implements a change in the unit of payment from 60-day episodes of care
to 30-day periods of care, as required by section 51001 of the
Bipartisan Budget Act of 2018, hereinafter referred to the ``BBA of
2018'', and finalizes a 30-day payment amount for CY 2020.
Additionally, this final rule with comment period: Modifies the payment
regulations pertaining to the content of the home health plan of care;
allows therapist assistants to furnish maintenance therapy; and changes
the split percentage payment approach under the HH PPS. For the Home
Health Value-Based Purchasing (HHVBP) model, we are finalizing
provisions requiring the public reporting of the Total Performance
Score (TPS) and the TPS Percentile Ranking from the Performance Year 5
(CY 2020) Annual TPS and Payment Adjustment Report for each home health
agency in the nine Model states that qualified for a payment adjustment
for CY 2020. This final rule with comment period also finalizes the
following updates to the Home Health Quality Reporting Program (HH
QRP): Removal of a measure; adoption of two new measures; modification
of an existing measure; and a requirement for HHA's to report
standardized patient assessment data beginning with the CY 2022 HH QRP.
Additionally, we are finalizing our proposal to re-designate our
current HH QRP regulations in a different section of our regulations
and to codify other current policies in that new regulatory section
with one substantive change as well as a few technical edits. We are
not finalizing our proposal to remove question 10 from all of the HH
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
surveys. Lastly, it sets forth routine updates to the home infusion
therapy payment rates for CY 2020, payment provisions for home infusion
therapy services for CY 2021 and subsequent years, and solicits
comments on options to enhance future efforts to improve policies
related to coverage of eligible drugs for home infusion therapy.
DATES: Effective Date: This final rule with comment period is effective
January 1, 2020.
Comment Date: To be assured consideration, comments on the criteria
that can be considered to allow coverage of additional drugs under the
DME benefit discussed in section VI.D. of this final rule with comment
period must be received at one of the addresses provided below, no
later than 5 p.m. on December 30, 2019.
ADDRESSES: In commenting, please refer to file code CMS-1711-FC.
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-1711-FC, 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-1711-FC, 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 Prospective Payment System (HH PPS) or home infusion
payment.
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 Value-Based Purchasing
(HHVBP) Model, 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].
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.
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Costs and Benefits
II. Overview of the Home Health Prospective Payment System (HH PPS)
A. Statutory Background
B. Current System for Payment of Home Health Services
C. New Home Health Prospective Payment System for CY 2020 and
Subsequent Years
D. Analysis of CY 2017 HHA Cost Report Data
III. Payment Under the Home Health Prospective Payment System (HH
PPS)
A. Implementation of the Patient-Driven Groupings Model (PDGM)
for CY 2020
B. Implementation of a 30-Day Unit of Payment for CY 2020
C. CY 2020 HH PPS Case-Mix Weights for 60-Day Episodes of Care
Spanning Implementation of the PDGM
D. CY 2020 PDGM Case-Mix Weights and Low-Utilization Payment
Adjustment (LUPA) Thresholds
E. CY 2020 Home Health Payment Rate Updates
F. Payments for High-Cost Outliers under the HH PPS
G. Changes to the Split-Percentage Payment Approach for HHAs in
CY 2020 and Subsequent Years
H. Change To Allow Therapist Assistants To Perform Maintenance
Therapy
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I. Changes to the Home Health Plan of Care Regulations at Sec.
409.43
IV. Home Health Value-Based Purchasing (HHVBP) Model
A. Background
B. Public Reporting of Total Performance Scores and Percentile
Rankings Under the HHVBP Model
C. Removal of Improvement in Pain Interfering With Activity
Measure (NQF #0177)
V. Home Health Quality Reporting Program (HH QRP)
A. Background and Statutory Authority
B. General Considerations Used for the Selection of Quality
Measures for the HH QRP
C. Quality Measures Currently Adopted for the CY 2021 HH QRP
D Removal of HH QRP Measures Beginning With the CY 2022 HH QRP
E. New and Modified HH QRP Quality Measures Beginning With the
CY 2022 HH QRP
F. HH QRP Quality Measures, Measure Concepts, and Standardized
Patient Assessment Data Elements Under Consideration for Future
Years: Request for Information
G. Standardized Patient Assessment Data Reporting Beginning With
the CY 2022 HH QRP
H. Standardized Patient Assessment Data by Category
I. Form, Manner, and Timing of Data Submission Under the HH QRP
J. Codification of the Home Health Quality Reporting Program
Requirements
K. Home Health Care Consumer Assessment of Healthcare Providers
and Systems (CAHPS[supreg]) Survey (HHCAHPS)
VI. Medicare Coverage of Home Infusion Therapy Services
A. Background and Overview
B. CY 2020 Temporary Transitional Payment Rates for Home
Infusion Therapy Services
C. Home Infusion Therapy Services for CY 2021 and Subsequent
Years
D. Payment Categories and Amounts for Home Infusion Therapy
Services for CY 2021
E. Required Payment Adjustments for CY 2021 Home Infusion
Therapy Services
F. Other Optional Payment Adjustments/Prior Authorization for CY
2021 Home Infusion Therapy Services
G. Billing Procedures for CY 2021 Home Infusion Therapy Services
VII. Waiver of Proposed Rule
VIII. Collection of Information Requirements
IX. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Anticipated Effects
D. Detailed Economic Analysis
E. Alternatives Considered
F. Accounting Statement and Tables
G. Regulatory Reform Analysis Under E.O. 13771
H. Conclusion
Regulation Text
I. Executive Summary
A. Purpose
1. Home Health Prospective Payment System (HH PPS)
This final rule with comment period updates the payment rates for
home health agencies (HHAs) for calendar year (CY) 2020, as required
under section 1895(b) of the Social Security Act (the Act). This rule
also updates the case-mix weights under section 1895(b)(4)(A)(i) and
(b)(4)(B) of the Act for 30-day periods of care beginning on or after
January 1, 2020. This final rule with comment period implements the
PDGM, a revised case-mix adjustment methodology that was finalized in
the CY 2019 HH PPS final rule with comment period (83 FR 56406), which
also implements the removal of therapy thresholds for payment as
required by section 1895(b)(4)(B)(ii) of the Act, as amended by section
51001(a)(3) of the BBA of 2018, and changes the unit of home health
payment from 60-day episodes of care to 30-day periods of care, as
required by section 1895(b)(2)(B) of the Act, as amended by 51001(a)(1)
of the BBA of 2018. This final rule with comment period allows
therapist assistants to furnish maintenance therapy; finalizes changes
to the payment regulations pertaining to the content of the home health
plan of care; updates technical regulations text changes which
clarifies the split-percentage payment approach for newly-enrolled HHAs
in CY 2020 and changes the split percentage payment approach for
existing HHAs in CY 2020 and subsequent years.
2. HHVBP
This final rule with comment period finalizes public reporting of
the Total Performance Score (TPS) and the TPS Percentile Ranking from
the Performance Year 5 (CY 2020) Annual TPS and Payment Adjustment
Report for each HHA that qualifies for a payment adjustment under the
HHVBP Model for CY 2020.
3. HH QRP
This final rule with comment period finalizes changes to the Home
Health Quality Reporting Program (HH QRP) requirements under the
authority of section 1895(b)(3)(B)(v) of the Act.
4. Home Infusion Therapy
This final rule with comment period finalizes payment provisions
for home infusion therapy services for CY 2021 and subsequent years in
accordance with section 1834(u) of the Act, as added by section 5012 of
the 21st Century Cures Act (Pub. L. 114-255).
B. Summary of the Major Provisions
1. Home Health Prospective Payment System (HH PPS)
Section III.A. of this final rule with comment period sets forth
the implementation of the Patient-Driven Groupings Model (PDGM) as
required by section 51001 of the BBA of 2018 (Pub. L. 115-123). The
PDGM is an alternate 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 BBA of 2018. Section III.B. of this final rule with
comment period implements a change in the unit of payment from a 60-day
episode of care to a 30-day period of care as required by section
1895(b)(2) of the Act, as amended by section 51001(a)(1) of the BBA of
2018. Section 1895(b)(3) of the Act requires that we calculate this 30-
day payment amount for CY 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 payment. The CY 2020 30-day payment amount (for
those HHAs that report the required quality data) will be $1,864.03,
which reflects an adjustment of -4.36 percent to maintain overall
budget neutrality under the PDGM.
Section III.C. of this final rule with comment period describes the
CY 2020 case-mix weights for those 60-day episodes that span the
implementation date of the PDGM and section III.D. of this rule
finalizes the CY 2020 PDGM case-mix weights and LUPA thresholds for 30-
day periods of care. In section III.E. of this final rule, we finalize
update the home health wage index and to update the national,
standardized 60-day episode of care and 30-day period of care payment
amounts, the national per-visit payment amounts, and the non-routine
supplies (NRS) conversion factor for 60-day episodes of care that begin
in 2019 and span the 2020 implementation date of the PDGM. The home
health payment update percentage for CY 2020 is 1.5 percent, as
required by section 53110 of the BBA of 2018. Section III.F. of this
final rule with comment period, finalizes changes change to the fixed-
dollar loss ratio to
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0.56 for CY 2020 under the PDGM in order to ensure that outlier
payments as a percentage of total payments is closer to, but no more
than, 2.5 percent, as required by section 1895(b)(5)(A) of the Act.
Section III.G. of this final rule with comment period, finalized
technical regulations correction at Sec. 484.205 regarding split-
percentage payments for newly-enrolled HHAs in CY 2020; and finalizes
the following additional changes to the split-percentage payment
approach: (1) A reduction in the up-front amount paid in response to a
Request for Anticipated Payment (RAP) to 20 percent of the estimated
final payment amount for both initial and subsequent 30-day periods of
care for CY 2020; (2) a reduction to the up-front amount paid in
response to a RAP to zero percent of the estimated final payment amount
for both initial and subsequent 30-day periods of care with a late
submission penalty for failure to submit the RAP within 5 calendar days
of the start of care for the first 30-day period within a 60-day
certification period and within 5 calendar days of day 31 for the
second, subsequent 30-day period in a 60-day certification period for
CY 2021; (3) the elimination of the split-percentage payment approach
entirely in CY 2022, replacing the RAP with a one-time submission of a
Notice of Admission (NOA) with a late submission penalty for failure to
submit the NOA within 5 calendar days of the start of care. In section
III.H. of this final rule with comment period, we are finalizing our
proposal to allow therapist assistants to furnish maintenance therapy
under the Medicare home health benefit, and section III.I. of this
final rule with comment period, we finalize a change in the payment
regulation text at Sec. 409.43 related to home health plan of care
requirements for payment.
2. HHVBP
In section IV. of this final rule with comment period, we are
finalizing provisions requiring public reporting performance data for
Performance Year (PY) 5 of the HHVBP Model. Specifically, we are
finalizing the public reporting of the TPS and the TPS Percentile
Ranking from the PY 5 (CY 2020) Annual TPS and Payment Adjustment
Report for each HHA in the nine Model states that qualified for a
payment adjustment for CY 2020.
3. HH QRP
In section V. of this final rule with comment period, we are
finalizing updates to the Home Health Quality Reporting Program (HH
QRP) including: The removal of one quality measure, the adoption of two
new quality measures, the modification of an existing measure, and a
requirement for HHAs to report standardized patient assessment data. In
section V.J. of this final rule, we are finalizing our proposal to re-
designate our current HH QRP regulations in a different section of our
regulations and to codify other current policies in that new regulatory
section with one substantive change as well as a few technical edits.
Finally, in section V.K. of the rule, we are not finalizing the removal
of question 10 from all HHCAHPS Surveys (both mail surveys and
telephone surveys).
4. Home Infusion Therapy
In section VI.A. of this final rule with comment period, we discuss
the general background of home infusion therapy services and how that
relates to the implementation of the new home infusion benefit in CY
2021. Section VI.B. of this final rule with comment period discusses
the updates to the CY 2020 home infusion therapy services temporary
transitional payment rates, in accordance with section 1834(u)(7) of
the Act. In section VI.C. of this final rule with comment period, we
are finalizing our proposal to add a new subpart P under the
regulations at 42 CFR part 414 to incorporate conforming regulations
text regarding conditions for payment for home infusion therapy
services for CY 2021 and subsequent years. Subpart P includes
beneficiary qualifications and plan of care requirements in accordance
with section 1861(iii) of the Act. In section VI.D. of this final rule
with comment period, we finalize payment provisions for the full
implementation of the home infusion therapy benefit in CY 2021 upon
expiration of the home infusion therapy services temporary transitional
payments in CY 2020. The home infusion therapy services payment system
is to be implemented starting in CY 2021, as mandated by section 5012
of the 21st Century Cures Act. The provisions in this section include
payment categories, amounts, and required and optional payment
adjustments. In section VI.E. of this final rule with comment period,
we finalize the use of the Geographic Adjustment Factor (GAF) to wage
adjust the home infusion therapy payment as required by section
1834(u)(1)(B)(i) of the Act. In section VI.F. of this final rule with
comment period, we summarize comments received on the proposed rule
regarding several topics for home infusion therapy services for CY 2021
such as: Optional payment adjustments, prior authorization, and high-
cost outliers. In section VI.G. of this final rule with comment period,
we discuss billing procedures for CY 2021 home infusion therapy
services. Lastly, given the new permanent home infusion therapy benefit
to be implemented beginning January 1, 2021, which includes payment for
professional services, including nursing, for parenteral drugs
administered intravenously or subcutaneously for a period of 15 minutes
or more through a pump that is a covered item of DME; we are soliciting
comments on options to enhance future efforts to improve policies
related to coverage of eligible drugs for home infusion therapy. In
response to stakeholder concerns regarding the limitations of the DME
LCDs for External Infusion Pumps that preclude coverage to certain
infused drugs, we seek comments on the criteria CMS could consider,
within the scope of the DME benefit, to allow coverage of additional
home infusion drugs.
C. Summary of Costs, Transfers, and Benefits
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
II. Overview of the Home Health Prospective Payment System
A. 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
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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 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 and these changes are discussed later in this final rule
with comment period.
B. Current System for Payment of Home Health Services
Generally, Medicare currently makes payment under the HH PPS on the
basis of a national, standardized 60-day episode payment rate that is
adjusted for the applicable case-mix and wage index. The national,
standardized 60-day episode rate includes the six home health
disciplines (skilled nursing, home health aide, physical therapy,
speech-language pathology, occupational therapy, and medical social
services). Payment for non-routine supplies (NRS) is not part of the
national, standardized 60-day episode rate, but is computed by
multiplying the relative weight for a particular NRS severity level by
the NRS conversion factor. Payment for durable medical equipment
covered under the HH benefit is made outside the HH PPS payment system.
To adjust for case-mix, the HH PPS uses a 153-category case-mix
classification system to assign patients to a home health resource
group (HHRG). The clinical severity level, functional severity level,
and service utilization are computed from responses to selected data
elements in the Outcome and Assessment Information Set (OASIS)
assessment instrument and are used to place the patient in a particular
HHRG. Each HHRG has an associated case-mix weight which is used in
calculating the payment for an episode. Therapy service use is measured
by the number of therapy visits provided during the episode and can be
categorized into nine visit level categories (or thresholds): 0 to 5;
6; 7 to 9; 10; 11 to 13; 14 to 15; 16 to 17; 18 to 19; and 20 or more
visits.
For episodes with four or fewer visits, Medicare pays national per-
visit rates based on the discipline(s) providing the services. An
episode consisting of four or fewer visits within a 60-day period
receives what is referred to as a low-utilization payment adjustment
(LUPA). Medicare also adjusts the national standardized 60-day episode
payment rate for certain intervening events that are subject to a
partial episode payment adjustment (PEP adjustment). For certain cases
that exceed a specific cost threshold, an outlier adjustment may also
be available.
C. New Home Health Prospective Payment System for CY 2020 and
Subsequent Years
In the CY 2019 HH PPS final rule with comment period (83 FR 56446),
we finalized a new patient case-mix adjustment methodology, the
Patient-Driven Groupings Model (PDGM), to shift the focus from volume
of services to a more patient-driven model that relies on patient
characteristics. For home health periods of care beginning on or after
January 1, 2020, the PDGM uses timing, admission source, principal and
other diagnoses, and functional impairment to case-mix adjust payments.
The PDGM results in 432 unique case-mix groups. Low-utilization
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payment adjustments (LUPAs) will vary; instead of the current four
visit threshold, each of the 432 case-mix groups has its own threshold
to determine if a 30-day period of care would receive a LUPA.
Additionally, non-routine supplies (NRS) are included in the base
payment rate for the PDGM instead of being separately adjusted as in
the current HH PPS. Also in the CY 2019 HH PPS final rule with comment
period, we finalized a change in the unit of home health payment from
60-day episodes of care to 30-day periods of care, and eliminated the
use of therapy thresholds used to adjust payments in accordance with
section 51001 of the BBA of 2018. Thirty-day periods of care will be
adjusted for outliers and partial episodes as applicable. Finally, for
CYs 2020 through 2022, home health services provided to beneficiaries
residing in rural counties will be increased based on rural county
classification (high utilization; low population density; or all
others) in accordance with section 50208 of the BBA of 2018.
D. Analysis of FY 2017 HHA Cost Report Data for 60-Day Episodes and 30-
Day Periods
In the CY 2019 HH PPS proposed rule (83 FR 32348), we provided a
summary of analysis on fiscal year (FY) 2016 HHA cost report data and
how such data, if used, would impact our estimate of the percentage
difference between Medicare payments and HHA costs. We stated in the CY
2019 HH PPS final rule with comment period (83 FR 56414) that we will
continue to monitor the impacts due to policy changes and will provide
the industry with periodic updates on our analysis in rulemaking and/or
announcements on the HHA Center web page.
In this year's proposed rule (84 FR 34602), we examined FY 2017 HHA
cost reports as this is the most recent and complete cost report data
at the time of rulemaking. We include this analysis again in this final
rule with comment period. We examined the estimated 60-day episode
costs using FY 2017 cost reports and CY 2017 home health claims and the
estimated costs for 60-day episodes by discipline and the total
estimated cost for a 60-day episode for 2017 is shown in Table 2.
[GRAPHIC] [TIFF OMITTED] TR08NO19.001
To estimate the costs for CY 2020, we updated the estimated 60-day
episode costs with NRS by the home health market basket update, minus
the multifactor productivity adjustment for CYs 2018 and 2019. In the
proposed rule, we estimated the CY 2020 costs by using the home health
market basket update of 1.5 percent as required by the BBA of 2018.
However, for this final rule with comment period, we believe that we
should be consistent with the estimation of cost calculations for
purposes of analyzing the payment adequacy. This would warrant the same
approach for estimating CY 2020 costs as was used for CYs 2018 and
2019. Therefore, for this final rule with comment period, we calculated
the estimated CY 2020 60-day episode costs and 30-day period costs by
applying each year's market basket update minus the multifactor
productivity factor for that year. For CY 2020, based on IHS Global
Inc. 2019 q3 forecast, the home health market basket update is
forecasted to be 2.9 percent; the MFP adjustment is forecasted to be
0.3 percent resulting in a forecasted MFP-adjusted home health market
basket update of 2.6 percent. The estimated costs for 60-day episodes
by discipline and the total estimated cost for a 60-day episode for CY
2020 is shown in Table 3.
[[Page 60484]]
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The CY 2020 60-day episode payment will be $3,220.79, approximately
16 percent more than the estimated CY 2020 60-day episode cost of
$2,767.15.
Next, we also looked at the estimated costs for 30-day periods of
care in 2017 using FY 2017 cost reports and CY 2017 claims. Thirty-day
periods were simulated from 60-day episodes and we excluded low-
utilization payment adjusted episodes and partial-episode-payment
adjusted episodes. The 30-day periods were linked to OASIS assessments
and covered the 60-day episodes ending in CY 2017. The estimated costs
for 30-day periods by discipline and the total estimated cost for a 30-
day period for 2017 is shown in Table 4.
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Using the same approach as calculating the estimated CY 2020 60-day
episode costs, we updated the estimated 30-day period costs with NRS by
the home health market basket update, minus the multifactor
productivity adjustment for CYs 2018 2019, and 2020. The estimated
costs for 30-day periods by discipline and the total estimated cost for
a 30-day period for CY 2020 is shown in Table 5.
[[Page 60485]]
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The estimated, budget-neutral 30-day payment for CY 2020 is,
$1,824.99 as described in section III.E. of this final rule with
comment period. Updating this amount by the CY 2020 home health market
basket update of 1.5 percent and the wage index budget neutrality
factor results in an estimated CY 2020 30-day payment amount of
$1,864.03 (as described in section III.B. of this final rule with
comment period) approximately 16 percent more than the estimated CY
2020 30-day period cost of $1,608.82. After implementation of the 30-
day unit of payment and the PDGM in CY 2020, we will continue to
analyze the costs by discipline as well as the overall cost for a 30-
day period of care to determine the effects, if any, of these changes.
III. Payment Under the Home Health Prospective Payment System (HH PPS)
A. Implementation of the Patient-Driven Groupings Model (PDGM) for CY
2020
1. Background and Legislative History
In the CY 2019 HH PPS final rule with comment period (83 FR 56406),
we finalized provisions to implement changes mandated by the BBA of
2018 for CY 2020, which included a change in the unit of payment from a
60-day episode of care to a 30-day period of care, as required by
section 51001(a)(1)(B), and the elimination of therapy thresholds used
for adjusting home health payment, as required by section
51001(a)(3)(B). In order to eliminate the use of therapy thresholds in
adjusting payment under the HH PPS, we finalized an alternative case
mix-adjustment methodology, known as the Patient-Driven Groupings Model
(PDGM), to be implemented for home health periods of care beginning on
or after January 1, 2020.
In regard to the 30-day unit of payment, section 51001(a)(1) of the
BBA of 2018 amended section 1895(b)(2) of the Act by adding a new
subparagraph (B) to require the Secretary to apply a 30-day unit of
service, effective 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.
Section 1895(b)(3)(A)(iv) of the Act additionally 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) and these assumptions
are further described in section III.B. of this final rule with comment
period.
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.
[[Page 60486]]
2. Overview and CY 2020 Implementation of the PDGM
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 PDGM for home health periods of care beginning on or after January
1, 2020. We believe that the PDGM case-mix methodology better aligns
payment with patient care needs and is a patient-centered model that
groups periods of care in a manner consistent with how clinicians
differentiate between patients and the primary reason for needing home
health care. This final rule with comment period effectuates the
requirements for the implementation of the PDGM, as well as finalizes
updates to the PDGM case-mix weights and payment rates, which would be
effective on January 1, 2020. The PDGM and a change to a 30-day unit of
payment were finalized in the CY 2019 HH PPS final rule with comment
period (83 FR 56406) and, as such, there were no new policy proposals
in the CY 2020 home health proposed rule on the structure of the PDGM
or the change to a 30-day unit of payment. However, there were
proposals related to the split-percentage payments upon implementation
of the PDGM and the 30-day unit of payment as described in section
III.G. of this final rule with comment period.
The PDGM uses 30-day periods of care rather than 60-day episodes of
care as the unit of payment, as required by section 51001(a)(1)(B) of
the BBA of 2018; eliminates the use of the number of therapy visits
provided to determine payment, as required by section 51001(a)(3)(B) of
the BBA of 2018; and relies more heavily on clinical characteristics
and other patient information (for example, diagnosis, functional
level, comorbid conditions, admission source) to place patients into
clinically meaningful payment categories. A national, standardized 30-
day period payment amount, as described in section III.E. of this final
rule with comment period, will be adjusted by the case-mix weights as
determined by the variables in the PDGM. Payment for non-routine
supplies (NRS) is now included in the national, standardized 30-day
payment amount. In total, there are 432 different payment groups in the
PDGM. These 432 Home Health Resource Groups (HHRGs) represent the
different payment groups based on five main case-mix variables under
the PDGM, as shown in Figure B1, and subsequently described in more
detail throughout this section.
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
final rule with comment period (timing, admission source, clinical
grouping, functional impairment level, and comorbidity adjustment)
using a fixed effects model. Annually recalibrating the PDGM case-mix
weights ensures that the case-mix weights reflect the most recent
utilization data at the time of annual rulemaking. The final CY 2020
PDGM case-mix weights are listed in section III.D. of this final rule
with comment period.
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a. Timing
Under the PDGM, 30-day periods of care will be classified as
``early'' or ``late'' depending on when they occur within a sequence of
30-day periods. Under the PDGM, the first 30-day period of care will be
classified as early and all subsequent 30-day periods of care in the
sequence (second or later) will be classified as late. A 30-day period
will 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 will come
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 will continue on a 60-day basis.
Specifically, certifications and re-certifications continue on a 60-day
basis and the comprehensive assessment will 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 will also be 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 will be designated as
institutional admissions.
The institutional admission source category will also include
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
[[Page 60488]]
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 will 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 we would expect the HHA to 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 will
determine the appropriate admission source for final claim payment. The
OASIS assessment will not be utilized in evaluating for admission
source information. We believe that 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 will 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 will 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 will 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.
However, situations in which the HHA has information about the
acute or post-acute care stay, HHAs will be allowed to manually
indicate on Medicare home health claims that an institutional admission
source had occurred prior to the processing of an acute/post-acute
Medicare claim, in order to receive higher payment associated with the
institutional admission source. This will be done through the reporting
of one of two admission source occurrence codes on home health claims--
Occurrence Code 61: to indicate an acute care hospital
discharge within 14 days prior to the ``From Date'' of any home health
claim; or
Occurrence Code 62: to indicate a SNF, IRF, LTCH, or IPF
discharge with 14 days prior to the ``Admission Date'' of the first
home health claim.
If the HHA does not include an occurrence code on the HH claim to
indicate that that the home health patient had a previous acute or
post-acute care stay, the period of care will be categorized as a
community admission source. However, if later a Medicare acute or post-
acute care claim for an institutional stay occurring within 14 days of
the home health admission is submitted within the timely filing
deadline and processed by the Medicare systems, the HH claim will be
automatically adjusted as an institutional admission and the
appropriate payment modifications will be made. 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 can be found in Change Request 11081, ``Home Health (HH)
Patient-Drive Groupings Model (PDGM)-Split Implementation''.\1\
Accordingly, the Medicare Claims Processing Manual, chapter 10,\2\ has
been updated to reflect all of the claims processing changes associated
with implementation of the PDGM.
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\1\ Home Health (HH) Patient-Driven Groupings Model (PDGM)--
Split Implementation Change Request. February 15, 2019. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4244CP.pdf.
\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 will be 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 6.
[[Page 60489]]
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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. However, a
change in the principal diagnosis does not necessarily mean that an
``other follow-up'' OASIS assessment (RFA 05) would need to be
completed just to make the diagnoses match. However, if a patient
experienced a significant change in condition before the start of a
subsequent, contiguous 30-day period of care, for example due to a
fall, in accordance with Sec. 484.55(d)(1)(ii) the HHA is required to
update the comprehensive assessment. The Home Health Agency
Interpretive Guidelines \3\ for Sec. 484.55(d), state that a marked
improvement or worsening of a patient's condition, which changes, and
was not anticipated in, the patient's plan of care would be considered
a ``major decline or improvement in the patient's health status'' that
would warrant update and revision of the comprehensive assessment.\4\
Additionally, in accordance with Sec. 484.60, the total plan of care
must be reviewed and revised by the physician who is responsible for
the home health plan of care and the HHA as frequently as the patient's
condition or needs require, but no less frequently than once every 60
days, beginning with the start of care date.
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\3\ Home Health Agency (HHA) Interpretive Guidelines. August 31,
2018. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO18-25-HHA.pdf.
\4\ State Operations Manual (SOM), Appendix B. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO18-25-HHA.pdf.
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In the event of a significant change of condition warranting an
updated comprehensive assessment, an ``other follow-up assessment''
(RFA 05) would be submitted before the start of a subsequent,
contiguous 30-day period, which may reflect a change in the functional
impairment level and the second 30-day claim would be grouped into its
appropriate case-mix group accordingly. An ``other follow-up
assessment'' is a comprehensive assessment conducted due to a major
decline or improvement in patient's health status occurring at a time
other than during the last 5 days of the episode. This assessment is
done to re-evaluate the patient's condition, allowing revision to the
patient's care plan as appropriate. The ``Outcome and Assessment
Information Set OASIS-D Guidance Manual,'' effective January 1, 2019,
provides more detailed guidance for the completion of an ``other
follow-up'' assessment.\5\ In this respect, two 30-day periods can have
two different case-mix groups to reflect any changes in patient
condition. HHAs must be sure to update the assessment completion date
on the second 30-day claim if a follow-up assessment changes the case-
mix group to ensure the claim can be matched to the follow-up
assessment. HHAs can submit an adjustment to the original claim
submitted if an assessment was completed before the start of the second
30-day period, but was received after the claim was submitted and if
the assessment items would change the payment grouping.
---------------------------------------------------------------------------
\5\ Outcome and Assessment Information Set OASIS-D Guidance
Manual. January 1, 2019. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-D-Guidance-Manual-final.pdf.
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HHAs would determine whether or not to complete a follow-up OASIS
assessment for a second 30-day period of care depending on the
individual's clinical circumstances. For example, if the only change
from the first 30-day period and the second 30-day period is a change
to the principal diagnosis and there is no change in the patient's
function, the HHA may determine it is not necessary to complete a
follow-up assessment. Therefore, the expectation is that HHAs would
determine whether an ``other follow-up'' assessment is required based
on the individual's overall condition, the effects of the change on the
overall home health plan of care, and in accordance with the home
health CoPs,\6\ interpretive guidelines, and the OASIS D Guidance
Manual instructions, as previously noted.
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\6\ Home Health Conditions of Participation. https://www.ecfr.gov/cgi-bin/text-idx?SID=fb4353988ab209999ca866efc142a601&mc=true&node=pt42.5.484&rgn=div5.
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For case-mix adjustment purposes, the principal diagnosis reported
on the home health claim will determine the clinical group for each 30-
day period of care. Currently, billing instructions state that the
principal diagnosis on the OASIS must also be the principal diagnosis
on the final claim; however, we will update our billing instructions to
clarify that there will be no need for the HHA to complete an ``other
follow-up'' assessment (an RFA 05) just to make the diagnoses match.
Therefore, for claim ``From'' dates on or after January 1, 2020, the
ICD-10-CM code and principal diagnosis used for
[[Page 60490]]
payment grouping will be from the claim rather than the OASIS. As a
result, the claim and OASIS diagnosis codes will no longer be expected
to match in all cases. Additional claims processing guidance, including
the role of the OASIS item set is included in the Medicare Claims
Processing Manual, chapter 10.
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. While there
are clinical groups where the primary reason for home health services
is for therapy (for example, Musculoskeletal Rehabilitation) and other
clinical groups where the primary reason for home health services is
for nursing (for example, Complex Nursing Interventions), 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.
Finally, to accompany this final rule with comment period, we
updated the Interactive Grouper Tool posted on both the HHA Center web
page (https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html) and the PDGM web page (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html). This
Interactive Grouper Tool includes all of the ICD-10-CM diagnosis codes
used in the PDGM and may be used by HHAs to generate PDGM case-mix
weights for their patient census. This tool is for informational and
illustrative purposes only. This Interactive Grouper Tool has been
provided to assist HHAs in understanding the effects of the transition
to the PDGM and will not be updated on an annual basis after CY 2020 as
HHAs will have the opportunity download the HH PPS Grouper annually.
The final grouper for CY 2020 will be posted with this final rule with
comment period and can be found on the following website: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/CaseMixGrouperSoftware.html. Additionally, HHAs can also request a Home
Health Claims-OASIS Limited Data Set (LDS) to accompany the CY 2020 HH
PPS final rule with comment period to support HHAs in evaluating the
effects of the PDGM. The Home Health Claims-OASIS LDS file can be
requested by following the instructions on the CMS Limited Data Set
(LDS) Files website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-_NewLDS.html.
d. Functional Impairment Level
Under the PDGM, 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 as listed in Table 7.
[GRAPHIC] [TIFF OMITTED] TR08NO19.007
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 Home
Health Center web page.\7\ 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. For
CY 2020, we used CY 2018 claims data to update the functional points
and functional impairment levels by clinical group. The updated OASIS
functional points table and the table of functional impairment levels
by clinical group for CY 2020 are listed in Tables 8 and 9
respectively. For ease of use, instead of listing the response
categories and the associated points (as shown in Table 28 in the CY
2019 HH PPS final rule with comment period (83 FR 56478), we have
reformatted the OASIS Functional Item Response Points (Table 8 to
identify how the OASIS functional items used for the functional
impairment level are assigned points under the PDGM. In this CY 2020 HH
PPS final rule with comment period, we updated the points for the OASIS
functional item response categories and the functional impairment
levels by clinical group using the most recent, available claims data.
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\7\ Overview of the Home Health Groupings Model. November 18,
2016. https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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[[Page 60493]]
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 OASIS assessment based on the claims ``from date.'' The
finalized CY 2020 functional points table and the functional impairment
level thresholds table are posted on the HHA Center web page as well as
on the PDGM web page.
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 diagnoses have at
least as high as the median resource use and are reported in more than
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.
For CY 2020, there are 13 low comorbidity adjustment subgroups as
identified in Table 10 and 31 high comorbidity adjustment interaction
subgroups as identified in Table 11.
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[[Page 60494]]
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[[Page 60495]]
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. The finalized CY 2020 low
comorbidity adjustment subgroups and the high comorbidity adjustment
interaction subgroups including those diagnoses within each of these
comorbidity adjustments are posted on the HHA Center web page as well
as on the PDGM web page.
While we did not solicit comments on the PDGM as it was finalized
in the CY 2019 HH PPS final rule with comment period (83 FR 56406), we
did receive 179 comments on various components of the finalized PDGM
from home health agencies, industry associations, as well as
individuals. We received a few general comments on the PDGM as a whole.
A few comments were received on the admission source case-mix variable,
elimination of therapy thresholds, and the comorbidity adjustment;
however, the majority of these comments were specific ICD 10-CM code
requests to include certain previously excluded diagnosis codes as part
of the clinical grouping variable or to move specific diagnosis codes
from one clinical group to another. These comments and our responses
are summarized in this section of this final rule with comment period.
1. General PDGM Comments
Comment: Several commenters stated they are very encouraged by
CMS's efforts to develop a valid and reliable case mix adjustment model
that relies on patient characteristics rather than resource use to
determine the amount of payment in individual service claims. However,
these commenters expressed concern that the PDGM could create financial
incentives for home health agencies to under-supply needed care through
inappropriate early discharge, improperly limiting the number of visits
or types of services provided, or discouraging serving individuals with
longer-term needs and people without a prior institutional stay. A
commenter recommended that CMS monitor these issues and quality of care
during initial implementation of the PDGM in ways that will allow CMS
to quickly understand and address emerging problems affecting the
provision of home health services. This commenter also suggested that
CMS educate home health agencies as well as beneficiaries and their
family caregivers about the need for beneficiaries to receive high-
quality home health care that meets each Medicare beneficiary's unique
needs. Other suggestions included requiring agencies to provide clear,
accurate information about what Medicare covers and beneficiary appeal
rights and updating CMS educational materials for beneficiaries to
assist in this effort. Another commenter urged CMS to be transparent
about its education budget and include information about the different
mechanisms it will use for the education of providers, beneficiaries,
and their family caregivers (as appropriate).
Response: We appreciate commenter support of a case-mix system
based on patient-characteristics and other clinical information, rather
than one based on the volume of services provided. We agree that this
is a more accurate way to align payment with the cost of providing
care. However, we recognize stakeholder concerns about possible
perverse financial incentives that could arise as a result of
transitioning to a new case-mix adjustment methodology and a change in
the unit of payment. We reiterate that we expect the provision of
services to be made to best meet the patient's care needs and in
accordance with the home health CoPs at Sec. 484.60 which sets forth
the requirements for the content of the individualized home health plan
of care which includes the types of services, supplies, and equipment
required; the frequency and duration of visits to be made; as well as
patient and caregiver education and training to facilitate timely
discharge. Therefore, we do not expect HHAs to under-supply care or
services; reduce the number of visits in response to payment; or
inappropriately discharge a patient receiving Medicare home health
services as these would be violations of the CoPs and could also
subject HHAs to program integrity measures.
We also note that the home health CoPs at Sec. 484.50(c) set forth
patient rights, which include the patient's right to be involved in the
plan of care, the right to be informed of any changes to the plan of
care, as well as expected coverage, and possible beneficiary financial
liability. Therefore, HHAs are already tasked with informing
beneficiaries as to their rights and coverage under the Medicare home
health benefit. Moreover, CMS does routinely update its public
materials to ensure relevant stakeholders are informed of any policy,
coverage, or payment changes. This includes updates to the Medicare
Benefit Policy Manual, the ``Medicare and You'' Handbook, ``Medicare's
Home Health Benefit'' booklet, and MLN Matters[supreg] articles on
various aspects of the home health benefit. As with any policy,
coverage, or payment change, we will update the necessary public
information to ensure full transparency and to provide ample resources
for beneficiaries and their families, as well as for home health
agencies. The goal of the PDGM is to more accurately align home health
payment with patient needs. We note that each individual policy change
does not have a corresponding individual educational budget connected
with its implementation; therefore this is not information we can
provide. We acknowledge that the change to a new case-mix system may
have unintended consequences through shifts in home health practices.
However, in the CY 2020 HH PPS proposed rule, we stated that we expect
the provision of services to be made to best meet the patient's care
needs and in accordance with existing regulations. We also noted that
we would monitor any changes in utilization patterns, beneficiary
impact, and provider behavior to see if any refinements to the PDGM
would be warranted, or if any concerns are identified that may signal
the need for appropriate program integrity measures.
Comment: A commenter stated that under the current HH PPS, HHAs'
costs are ``frontloaded'' and incurred regardless of whether a second
30-day period occurs within a 60-day episode. This commenter stated
that CMS should account for these costs and allocate payment weights
more toward the first 30-day period in each 60-day episode to ensure
that payments are accurately aligned with resource use. Commenters
express several concerns with the use of cost report data rather than
Bureau of Labor Statistics (BLS) wage data to account for the cost of
therapy services; thus, commenters recommend CMS use BLS wage-weighted
minutes instead of the approach finalized in the CY 2019 final rule
with comment period.
Response: We note that we provided detailed analysis on the
estimated costs of 30-day periods of care using a cost-per-minute plus
non-routine supply (CPM + NRS) approach in the CY 2019 HH PPS proposed
rule (83 FR 32387). We also provided analysis on the average resource
use by timing where early 30-day periods have higher resource use that
later 30-day periods (83 FR 32392). Likewise, in the CY 2019
[[Page 60496]]
HH PPS final rule with comment period (83 FR 56471), we finalized the
admission source case-mix variable under the PDGM where ``early'' 30-
day periods of care receive a higher payment than ``late'' 30-day
periods of care. Commenters supported this payment differential as it
more accurately reflects HHA costs that are typically higher during the
first 30-day period of care, compared to later 30-day periods of care.
When we finalized the CPM+NRS approach to calculating the costs of
care in the CY 2019 HH PPS final rule with comment period, we stated
that we believe that the use of HHA Medicare cost reports better
reflects changes in utilization, provider payments, and supply amongst
Medicare-certified HHAs that occur over time. Under the Wage-Weighted
Minutes of Care (WWMC) approach, using the BLS average hourly wage
rates for the entire home health care service industry does not reflect
changes in Medicare home health utilization that impact costs, such as
the allocation of overhead costs when Medicare home health visit
patterns change. Using data from HHA Medicare cost reports better
represents the total costs incurred during a 30-day period (including,
but not limited to, direct patient care contract labor, overhead, and
transportation costs), while the WWMC method provides an estimate of
only the labor costs (wage and fringe benefit costs) related to direct
patient care from patient visits that are incurred during a 30-day
period.
Comment: A commenter suggested an additional alternative to
consider regarding the implementation of the PDGM. Specifically, this
commenter suggested a potential pilot program to test not only the PDGM
but possibly the PDPM payment system for skilled nursing facilities to
consider some form of a post-acute bundle with shared savings.
Response: We appreciate the commenter's suggestions for innovative
ways to improve the health care system and payment models. However, we
note that the change in the unit of payment and the case-mix
methodology is mandated by the BBA of 2018, as such we are required to
implement such changes beginning on January 1, 2020.
2. Admission Source
Comment: A commenter stated that it appears counterintuitive to
have a different reimbursement for community versus institutional
admission source stating that the goal of home health care is to keep
the patients out of the hospital. A commenter expressed concern that
even though the application of an admission source measure may seem
warranted given data demonstrating different resource use, doing so may
incentivize agencies to give priority to post-acute patients over those
who are admitted from the community. This commenter stated that the
financial impact of the PDGM admission source measure also highlights
the inherent weakness of all the other PDGM measures. A few commenters
supported the admission source as an indicator of predicted home health
resource use.
Response: We agree that the provision of home health services may
play an important role in keeping patient's out of the hospital,
whether the patient is admitted to home health from an institutional
source or from the community. However, the payment adjustments
associated with the PDGM case-mix variables are based on the cost of
providing care. As described in the CY 2018 HH PPS proposed rule (82 FR
35311), our analytic findings demonstrate that institutional admissions
have significantly higher average resource use when compared with
community admissions, which ultimately led to the inclusion of the
admission source category within the framework of the alternative case-
mix adjustment methodology refinements. Additionally, in the CY 2018 HH
PPS proposed rule (82 FR 35309), we stated that in our review of
related scholarly research, we found that beneficiaries admitted
directly or recently from an institutional setting (acute or post-acute
care (PAC)) tend to have different care needs and higher resource use
than those admitted from the community, thus indicating the need for
differentiated payment amounts. Furthermore, in the CY 2018 proposed
rule, we provided detailed analysis and research to support the
inclusion of an admission source category for case-mix adjustment. We
continue to believe that having a case-mix variable accounting for
admission source is clinically appropriate, will address the more
intensive care needs of those admitted to home health from an
institutional setting, and will more accurately align payment with the
cost of providing home health care.
To address concerns that the admission source variable may create
the incentive to favor institutional admission sources, we fully intend
to monitor provider behavior in response to the new PDGM. As we receive
and evaluate new data related to the provision of Medicare home health
care under the PDGM, we will reassess the appropriateness of the
payment levels for all of the case-mix variables, including admission
source, to determine if HHAs are inappropriately changing their
behavior to favor institutional admission sources over community.
Additionally, we will share any concerning behavior or patterns with
the Medicare Administrative Contractors (MACs) and other program
integrity contractors, if warranted. We plan to monitor and identify
any variations in the patterns of care provided to home health
patients, including both increased and decreased provision of care to
Medicare beneficiaries. We remind stakeholders that the purpose of
case-mix adjustment is to align payment with the costs of providing
care. As such, certain case-mix variables may have a more significant
impact on the payment adjustment than others. However, the case-mix
variables in the PDGM work in tandem to fully capture patient
characteristics that translate to higher resource needs. The overall
payment for a home health period of care under the PDGM is determined
by the cumulative effect of all of the variables used in the case-mix
adjustments. Ultimately, the goal of the PDGM is to provide more
accurate payment based on the identified resource use of different
patient groups.
3. Therapy Thresholds
Comment: A few commenters disagreed with the elimination of the
therapy thresholds and expressed concern that the PDGM design will have
a negative impact on patients who need therapy services and the HHAs
that provide it. A commenter stated that therapy services are
extraordinarily valuable in the care of Medicare home health
beneficiaries and should be supported to the greatest degree possible.
Another commenter suggested elimination of the 30-day therapy
reassessment requirement stating this would duplicative and unnecessary
under PDGM, given that therapy visits are no longer a payment driver,
and that all visits must continue to demonstrate a skilled need,
independent of a formal reassessment. Many commenters urge CMS to
monitor the effects of PDGM and the implications on therapy utilization
due to concerns therapy would be underutilized, which could result in
beneficiaries going to inpatient settings rather than receiving care at
home. Some commenters recommend further analysis to compare utilization
of therapy revenue codes under the PPS and PDGM. In addition,
commenters encourage CMS to use the survey process to ensure that
beneficiaries continue to receive the appropriate level of therapy that
were medically
[[Page 60497]]
necessary in order to treat or manage the condition.
Response: We agree that therapy remains a valuable service for
Medicare home health beneficiaries. In response to the CY 2018 and 2019
HH PPS proposed rules, the majority of commenters agreed that the
elimination of therapy thresholds was appropriate because of the
financial incentive to overprovide therapy services. While the
functional impairment level adjustment in the PDGM is not meant to be a
direct proxy for the therapy thresholds, the PDGM has other case-mix
variables to adjust payment for those patients requiring multiple
therapy disciplines or those chronically ill patients with significant
functional impairment. We believe that also accounting for timing,
source of admission, clinical group (meaning the primary reason the
patient requires home health services), and the presence of
comorbidities will provide the necessary adjustments to payment to
ensure that care needs are met based on actual patient characteristics.
Furthermore, services are to be provided in accordance with the home
health plan of care established and periodically reviewed by the
certifying physician. Therefore, we expect that home health agencies
will continue to provide needed therapy services in accordance with the
CoPs at Sec. 484.60, which state that the individualized plan of care
must specify the care and services necessary to meet the patient-
specific needs as identified in the comprehensive assessment, including
identification of the responsible discipline(s), and the measurable
outcomes that the HHA anticipates will occur as a result of
implementing and coordinating the plan of care. Upon implementation of
the PDGM, we will monitor home health utilization, including the
provision of therapy services. Finally, we remind commenters that
section 51001(a)(3)(B) of the BBA of 2018 prohibits the use of therapy
thresholds as part of the overall case-mix adjustment for CY 2020 and
subsequent years. Consequently, we have no regulatory discretion in
this matter.
While we appreciate commenter suggestions to further reduce burden
by eliminating therapy reassessments, we did not propose to eliminate
the current 30-day therapy reassessment requirement at Sec.
409.44(c)(2)(i)(B) in the CY 2020 HH PPS proposed rule. When we
finalized the 30-day therapy reassessment requirement in the CY 2015 HH
PPS final rule (79 FR 66103), we stated that the qualified therapist
assists the physician in evaluating level of function, helps develop
the plan of care (revising it as necessary), prepares clinical and
progress notes, advises and consults with the family and other agency
personnel, and participates in in-service programs. Furthermore, in the
CY 2015 final rule, the overwhelming majority of commenters recommended
reassessing the patient at least once every 30 days as the most
appropriate time frame. Commenters stated that a 30 day reassessment
timeframe aligns with many state practice acts, which require that a
therapist reassess the patient at least once every 30 days. As part of
our response, we also referenced the American Physical Therapy
Association (APTA) guidelines which state that at least once a month,
the qualified therapist should conduct a supervisory visit with the
therapist assistant which should include: An on-site reexamination of
the patient/client; on-site review of the plan of care with appropriate
revision or termination; and evaluation of need and recommendation for
utilization of outside resources.\8\ We also stated that we believe
that requiring therapy reassessments at least once every 30 days, the
CoP requirements regarding the plan of care, and the APTA guidelines
together promote regular interaction between the therapist and the
patient. However, we recognize the importance of decreasing unnecessary
burden and we will continue to monitor home health utilization,
including the provision of therapy visits, to re-evaluate any existing
policies to determine if any additional changes should be proposed in
future rulemaking. Likewise, we understand commenter concerns about
potential underutilization of certain disciplines, especially therapy,
with the elimination of therapy thresholds. The home health CoPs have
requirements as to the content of the home health plan of care, as well
as providing services that are ordered by the physician as indicated in
the plan of care. Therefore, existing survey mechanisms are in place to
help ensure patient safety and quality standards. However, as we noted
in the CY 2019 HH PPS final rule with comment period, upon
implementation of the PDGM, we will continue to monitor the payment
system as we have done since the inception of the benefit. We will
closely monitor patterns related to utilization, including changes in
the composition of patients receiving the home health benefit and the
types and amounts of services they are receiving, as well as any
changes in the settings of care.
---------------------------------------------------------------------------
\8\ Direction and Supervision of the Physical Therapist
Assistant. August 30, 2018. http://www.apta.org/uploadedFiles/APTAorg/About_Us/Policies/Practice/DirectionSupervisionPTA.pdf.
---------------------------------------------------------------------------
Comment: A few commenters support the elimination of therapy as the
driver of payment and offered historical context to the potential
increase in therapy utilization as it relates to the Home Health
Quality Reporting Program. A commenter also identified potential
opportunity for oversight and monitoring to address ``problematic
HHAs'' that the commenter identifies as driving the therapy utilization
data since the inception of the HH PPS. Another commenter stated that
the elimination of therapy volumes as a determinant of reimbursement is
appropriate and that they anticipate the clinical groupings based on
diagnosis, along with the comorbidity adjustments will prove to be
acceptable elements of payment.
MedPAC also supports the elimination of therapy as a payment factor
because their March 2018 Report to Congress \9\ stated concerns about
the financial incentive to providing more therapy that is not
necessarily tied to patient characteristics, which is a recognized
vulnerability in the HH PPS. However, MedPAC believes additional
monitoring is necessary regarding the 30 day payment to understand
whether there is a new incentive for HHAs to provide just enough
services/visits to surpass the threshold for a second 30 day payment.
---------------------------------------------------------------------------
\9\ MedPAC Report to Congress, Home health care services, March
2018. http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch9_sec.pdf?sfvrsn=0.
---------------------------------------------------------------------------
Response: We appreciate commenter support regarding the elimination
of the therapy thresholds for use in adjusting home health payment. We
believe that elimination of the therapy thresholds is more in alignment
with the intent of the home health benefit to be patient-centered and
based on patient characteristics, such as functional status, and actual
patient needs. Likewise, we expect that any services provided would be
in accordance with all Federal and State laws, including all licensure
requirements. The provision of skilled therapy services as part of a
home health plan of care must also adhere to the home health CoPs, (42
CFR 484.60). We believe that the elimination of the therapy thresholds
will remove the financial incentive to provide therapy solely for
increased payment. Upon implementation of the PDGM and the 30-day unit
of payment, we will continue to monitor home health utilization,
including the provision of therapy services, as well as any shifts in
disciplines to determine if
[[Page 60498]]
any program integrity or survey efforts may be warranted.
4. Non-Routine Supplies (NRS)
Comment: A couple of commenters suggested that CMS should consider
the higher costs of wound care supplies and should pay more for such
supplies as part of the PDGM. Another commenter recommended that the
cost of non-routine supplies (NRS) should be included in outlier
payments.
Response: As finalized in the CY 2019 HH PPS final rule with
comment period (83 FR 56406), similar to the current system, NRS still
would be paid prospectively under the PDGM, but the PDGM eliminates the
separate case-mix adjustment model for NRS. We believe that the PDGM
offers an alternative method for accounting for NRS costs and payments
by grouping patients more likely to require high NRS utilization. Under
the PDGM, NRS costs are reflected in the average resource use that
drives the case-mix weights. If there is a high amount of NRS cost for
all periods in a particular group (holding all else equal), the
resource use for those periods will be higher relative to the overall
average and the case-mix weight will correspondingly be higher. We
appreciate the commenters' suggestion regarding the inclusion of
supplies in the outlier calculation under the PDGM. In order to
incorporate supply costs into the outlier calculation, significant
claims payment systems modifications would be required. However, after
implementation of the PDGM, we will continue to monitor the provision
of NRS and we will consider whether to add supply costs to the outlier
calculations and evaluate whether such a policy change is appropriate
for future rulemaking.
5. Clinical Groups
Comment: Some commenters made general remarks regarding the
diagnosis codes included in the clinical grouping case-mix variable. A
few commenters state that elimination of certain diagnosis codes would
narrow the home health benefit and may prevent access to care to which
Medicare beneficiaries are legally entitled. Another commenter stated
that the coding-related proposals could limit the home health benefit
for eligible beneficiaries in need of skilled maintenance therapy. A
commenter stated that the removal of certain diagnosis codes from the
clinical grouping would essentially eliminate coverage for skilled
services under the home health benefit and said that CMS should not
finalize elimination of these codes and should recalculate rates with
all existing codes included.
Response: The elimination of certain diagnosis codes from the HH
PPS Grouper is not unique to the PDGM as we have previously removed
codes from the 153-group HH PPS case-mix system that no longer have a
significant impact on resource use. As stated previously, the clinical
grouping is only one case-mix variable in the PDGM. These clinical
groups are designed to capture the most common types of care that HHAs
provide. Although the principal diagnosis code is the basis for the
clinical grouping, secondary diagnosis codes and patient
characteristics will be used to case-mix adjust the period further
through the comorbidity adjustment and functional level. We believe
that the PDGM has a robust set of clinical characteristics to ensure
that payment accurately aligns with patient needs and therefore, we do
not expect there to be any issues with patient access to home health
services. Furthermore, eligibility for home health services remains the
same as under the 153-group system. That is, individuals are eligible
for home health services if the following criteria are met: The
individual is confined to the home; is under the care of a physician;
is receiving services under a plan of care established and periodically
reviewed by a physician is in need of skilled nursing care on an
intermittent basis or physical therapy or speech-language pathology
therapy; has a continuing need for occupational therapy. Therefore, a
patient's principal or secondary diagnoses are not sole factors in
whether a patient is eligible for Medicare home health services. As
such, eligible beneficiaries are entitled to their Medicare home health
benefits and we do not expect there to be an access to care issue. With
respect to the provision of therapy services as they relate to the home
health period's clinical group, we should emphasize that although the
principal diagnosis is a contributing factor in the PDGM and determines
the clinical group, it is not the only consideration in determining
what home health services are needed in a patient's care plan. We
stated in the CY 2019 HH PPS proposed rule (83 FR 32401), that it is
the responsibility of the patient's treating physician to determine if
and what type of therapy (that is, maintenance or otherwise) the
patient needs regardless of clinical grouping. As such, we continue to
expect the ordering physician, in conjunction with the therapist, to
develop and follow a plan of care for any home health patient,
regardless of clinical group, as outlined in the skilled service
requirements when therapy is deemed reasonable and necessary.
Therefore, a home health period's clinical group should not solely
determine the type and extent of therapy needed for a particular
patient.
As described in the CY 2018 HH PPS proposed rule (82 FR 35313), to
inform the development of the clinical groups, our home health
contractor, Abt Associates and CMS conducted an extensive review of
diagnosis codes to identify the primary reasons for home health
services under the Medicare home health benefit. The published HHGM
(predecessor to the PDGM), technical report from December 2016 \10\ and
the CY 2018 HH PPS proposed rule (82 FR 35314), detail several reasons
why a diagnosis code was not assigned to one of the clinical groups.
These included if the diagnosis code was too vague, meaning the code
does not provide adequate information to support the need for skilled
home health services (for example H57.9, Unspecified disorder of eye
and adnexa); the code is subject to laterality for which the home
health clinician could assess the appropriate side (for example, some
diagnosis codes indicate laterality, specifying whether the condition
occurs on the left or right, or is bilateral); the code, based on ICD
10-CM, American Hospital Association (AHA) Coding Clinic, or Medicare
Code Edits (MCE) would indicate a non-home health service (for example,
dental codes); the code is a manifestation code subject to a
manifestation/etiology convention, meaning that the etiology code must
be reported as the principal diagnosis, or the code is subject to a
code first sequencing convention (for example, G99.2 myelopathy in
diseases classified elsewhere); the code identifies a condition which
would be unlikely to require home health services (for example, L81.2,
Freckles); the code is restricted to the acute care setting per ICD 10-
CM/AHA Coding Clinic, or the diagnosis indicates death as the outcome
(for example S06.1X7A, Traumatic cerebral edema with loss of
consciousness of any duration with death due to brain injury prior to
regaining consciousness). Overall, we continue to believe that the PDGM
clinical grouping includes a robust set of diagnosis codes and includes
more codes than under clinical dimension of the 153-group case-mix
system. Therefore, this should afford HHAs greater opportunity to more
fully describe patient characteristics through
[[Page 60499]]
principal and secondary diagnosis reporting on home health claims.
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\10\ ``Overview of the Home Health Groupings Model'' Technical
Report. November 18, 2016. https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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While there are certain diagnosis codes that are not assigned to a
clinical group under the PDGM for the reasons described, we remind
commenters that claims submitted with such codes are not denied; rather
they are returned to the provider for more definitive coding. The
importance of consistent, complete medical documentation cannot be
overemphasized. Without such documentation, accurate diagnosis coding
cannot be achieved; therefore, ICD-10-CM coding guidelines \11\ state
that the entire record should be reviewed to determine the specific
reason for the encounter and the conditions treated. We remind
stakeholders that if there is a question as to what the appropriate
principal (or secondary) diagnosis should be, the HHA should query the
certifying physician who is responsible for establishing the home
health plan of care.
---------------------------------------------------------------------------
\11\ ``ICD-10-CM Official Guidelines for Coding and Reporting FY
2020 (October 1, 2019-September 30, 2020). https://www.cms.gov/Medicare/Coding/0ICD10/Downloads/2020-Coding-Guidelines.pdf.
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Comment: One industry association stated it had a workgroup conduct
some analysis on the diagnosis codes and their assigned clinical groups
and they state that it was discovered that in a significant number of
instances a code assigned to one clinical grouping was also placed in a
different clinical grouping. They noted that in every case they
analyzed where a code was assigned to a different clinical grouping, it
was assigned to the Complex Nursing group. The commenter requested
clarification and CMS' rationale so they could share with other
industry stakeholders.
Response: We remind commenters that in developing the case-mix
weights for the PDGM, we examined the principal diagnosis codes
reported by HHAs and, in order to assign periods of care into the
appropriate clinical group representing the primary reason for home
health services, we also looked at OASIS item, M1030, ``Therapies''
(identifies whether the patient is receiving intravenous, parenteral
nutrition or enteral nutrition therapy at home) to see if home health
patients were receiving complex therapies for which the appropriate
case-mix adjustment should be made. Therefore, for those circumstances
in which the workgroup's analysis of the principal diagnosis would have
grouped the period of care into one of the MMTA subgroups, but the
actual period was grouped into Complex Nursing Interventions, this is
likely due to that period of care being assigned based on the response
to OASIS item M1030, reflecting complex nursing interventions provided
during the course of home health care. However, we note that for
implementation of the PDGM in CY 2020 and subsequent years, we have
assigned ICD-10-CM diagnosis codes to the Complex Nursing Interventions
group that reflect these more complex therapies previously identified
from the OASIS item M1030 (for example, Z45.2, Encounter for adjustment
and management of venous access device) and we will be using the
diagnosis codes reported on the home health claim and not OASIS items
to assign a period of care to a clinical group for case-mix adjustment
purposes.
Comment: Several commenters stated that symptom codes should be
allowed to be reported as the principal diagnosis and assigned to a
clinical group. A few commenters stated that disallowing symptom codes
for principal diagnosis consideration will cause HHAs to report a
principal diagnosis that would not truly represent the reason for the
home health encounter and would force HHAs to ``upcode''. A commenter
remarked that there is a significant portion of the elderly population
who exhibit symptomology but have declined further testing or the
medical community has decided not to order expensive tests since many
times the treatment remains the same. Several symptom codes were
specifically mentioned for inclusion in the clinical group variable by
a national industry association, as well as HHAs. Commenters suggested
that the following symptom codes should be in the MS Rehab clinical
group:
R26.89, Other abnormalities of gait and mobility
R29.6, Repeated falls
The following symptom codes were suggested to be included in the
clinical group variable, but without a recommendation for a specific
PDGM clinical group:
R00.1, Bradycardia
R41.82, Altered Mental Status
R42, Dizziness and giddiness.
And, several commenters suggested the following symptom codes
should be in the Neuro Rehab clinical group:
R27.0, Ataxia, unspecified
R13.10, Dysphagia
Response: As we have stated in the CY 2020 proposed rule and this
final rule with comment period, we do not support or condone coding
solely for purposes of higher payment (what commenters refer to as
``upcoding''). In accordance with ICD-10-CM coding guidelines, the
principal diagnosis reported is that ``condition established after
study to be chiefly responsible for occasioning the admission of the
patient to the hospital for care.'' For purposes of home health care
admission, this would be the diagnosis chiefly responsible for home
health services. Because of the home health requirements that the
individual receiving home health services must be certified for such
services and must have had a face-to-face encounter related to the
primary reason for home health care, we believe that by the time an
individual is admitted to home health, the patient has been seen by
other health care providers and a diagnosis has been established. We
note that we adopted a similar position as it relates hospice diagnosis
reporting. In the FY 2014 hospice proposed rule (78 FR 27831), we
stated that if a nonspecific, ill-defined symptom diagnosis is reported
as the principal hospice diagnosis, a comprehensive, individualized
patient-centered plan of care, as required, may be difficult to
accurately develop and implement, and, as a result, the hospice
beneficiary may not receive the full benefit of hospice services. We
believe that the same principle applies to home health beneficiaries
and that accurate documentation and diagnosis reporting is essential to
ensure that an individualized plan of care is established to meet the
patient's home health needs. Furthermore, the ICD-10-CM coding
guidelines state that codes for symptoms, signs, and ill-defined
conditions are not to be used as the principal diagnosis when a related
definitive diagnosis has been established. Therefore, because of the
inclusion of a clinical group for case-mix adjustment purposes
predicated on diagnosis reporting, we believe that HHAs would improve
their overall documentation and accuracy of their diagnosis code
reporting to reflect patient characteristics defined by diagnosis
codes, as well as other important patient information that reflects
resource utilization (for example functional impairment). As such, we
believe that the reporting of ill-defined symptom codes as the
principal diagnosis would be less frequent.
As we stated in the CY 2019 HH PPS final rule with comment period
(83 FR 56473), we believe that the majority of the R-codes (codes that
describe signs and symptoms, as opposed to diagnoses) are not
appropriate as principal diagnosis codes for grouping home health
periods into clinical groups. We
[[Page 60500]]
believe that the use of symptoms, signs, and abnormal clinical and
laboratory findings would make it difficult to meet the requirements of
an individualized plan of care as required at Sec. 484.60. Likewise,
we believe that clinically it is important for home health providers to
have a clear understanding of the patients' diagnoses in order to
safely and effectively furnish home health services. Interventions and
treatment aimed at mitigating signs and symptoms of a condition may
vary depending on the cause. For example, if a patient has been
referred to home health with a diagnosis of ``other abnormalities of
gait and mobility'' (R26.89), we believe it is important for the home
health clinician to know what is precipitating the abnormality. For
instance, a plan of care for a gait abnormality related to a
neurological diagnosis is likely to be different from a plan of care
for a gait abnormality due to a fracture or injury. Anecdotally, we
have heard that the home health referral may be non-specific or that
the physician may be in the process of determining a more definitive
diagnosis. However, with respect to patient safety and quality of care,
we believe it is important for a clinician to investigate the cause of
the signs and/or symptoms for which the referral was made. This may
involve calling the referring physician to gather more information
regarding the gait abnormality. We note that HHAs are required under
the home health CoPs at Sec. 484.60 to participate in care
coordination to assure the identification of patient needs and factors
that could affect patient safety and treatment efficacy. ICD-10-CM
coding guidelines are clear that R-codes are to be used when no more
specific diagnosis can be made even after all the facts bearing on the
case have been investigated. Therefore, these codes should not be used
as a principal diagnosis for the provision of home health services
while a physician may still be in the diagnostic process. By the time
the patient is referred to home health and meets the qualifications of
eligibility, we would expect that a more definitive code would
substantiate the need for services. Furthermore, commenters have
indicated a preference for greater specificity in the clinical groups,
therefore, we believe this should extend to the codes within the
clinical groups as well.
Regarding commenters suggesting that R29.6, Repeated falls, be
included in the MS Rehab group, we note that ICD-10-CM coding
guidelines state to only use R29.6 for use for encounters when a
patient has recently fallen and the reason for the fall is being
investigated. Given that the patient must be certified for home health
services and must have had a face-to-face encounter related to the
primary reason for home health services, we do not believe that this
particular symptom code would be appropriate for the principal
diagnosis to substantiate home health services. We believe that by the
time a home health referral is made, a more clearly defined diagnosis
would have been established to more accurately describe the patient's
condition. However, if the patient's condition has resulted in repeated
falls, the HHA would report Z91.81, History of falling, as a secondary
diagnosis to describe that the patient has fallen in the past and is at
future risk for falls to more accurately describe the patient's need
for home health services. For the same reasons as stated throughout
this response, we do not believe it appropriate to include R00.1
Bradycardia, R41.82, Altered Mental Status, or R42, Dizziness and
giddiness as part of the clinical group case-mix variable because of
the vague nature of symptom codes where there could be multiple reasons
for such symptoms. In order to develop an appropriate, individualized
home health plan of care, we believe it is clinically essential to
understand the causes of such symptoms to safely and effectively
provide home health services. Furthermore, it has been our longstanding
policy to avoid vague diagnoses for reporting and payment purposes.
Specifically, we stipulated in the 2008 HH PPS final rule (72 FR 49774)
that the case-mix system avoid, to the fullest extent possible, non-
specific or ambiguous ICD-9-CM codes, codes that represent general
symptomatic complaints in the elderly population, and codes that lack
consensus for clear diagnostic criteria within the medical community.
We note that diagnosis codes R00-R99 include symptoms, signs, abnormal
results of clinical or other investigative procedures, and ill-defined
conditions are limited for those circumstances where there is no
recorded diagnosis that is classifiable elsewhere. However, patients
are referred to home health from other clinical settings (either from a
facility or a community-based provider) and therefore, we believe that
the medical records from such referral source should provide
information as to the need for home health services, including the
diagnoses established by such providers. Clinically, this information
is needed to develop the individualized plan of care with patient-
specific goals. In the circumstance where such information is missing
or insufficient, we believe that HHAs should query these referring
providers to ensure they have a clear understanding of the conditions
affecting patients in need of home health services.
Regarding suggestions to include the symptom codes R27.0, Ataxia,
unspecified, and R13.10, Dysphagia, in the Neuro Rehab clinical group,
we reiterate our position as noted previously--that by the time a
patient is admitted for home health services, there should be
sufficient documentation in the patient's medical record to have an
established diagnosis, and that a symptom diagnosis should not be
reported as the principal diagnosis as this could be the result of
other conditions besides a neurological condition and therefore,
grouping the period of care into Neuro Rehab may not be appropriate. We
continue to believe that the home health clinician needs appropriate,
accurate clinical information, including the cause of such symptoms, in
order to develop an individualized plan of care to specify the services
necessary to meet the patient-specific needs.
However, we analyzed the frequency of the reporting of each of
these diagnoses and we note that in 2018, there were only 3,461 30-day
periods in which R27.0, Ataxia, unspecified, was reported as the
principal diagnosis. However, in looking at the reported secondary
diagnoses accompanying this principal diagnosis, HHAs reported
established diagnoses that could explain the reason for the unspecified
ataxia and would group the 30-day period of care into the Neuro Rehab
group. For example, we found reported secondary diagnoses of
Alzheimer's disease, Parkinson's disease, and polyneuropathy. Given
that symptom diagnoses should not be reported as the principal
diagnosis if there is an established diagnosis, we believe that the
established diagnosis would be reported first, and the symptom code,
unspecified ataxia, would be reported as a secondary diagnosis to fully
reflect patient characteristics. Furthermore, in reviewing the tabular
index in the CY 2020 ICD-10-CM official code set \12\ for ``ataxia'',
there are multiple diagnosis codes available to more accurately
describe the underlying condition causing the ataxia. We also note that
``unspecified'' codes should only be reported when the medical record
is
[[Page 60501]]
insufficient to assign a more specific code.
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\12\ 2020 ICD-10-CM web page. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM.html.
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We also analyzed the frequency of reporting of R13.10, dysphagia,
unspecified and we note that in 2018, there were approximately 28,000
30-day periods in which this particular code was reported as the
principal diagnosis. In looking at the reported secondary diagnoses
accompanying this principal diagnosis, we found that while there were
incidences where there were other reported diagnoses which could
explain the reason for the dysphagia, more often than not, there was no
clear clinical picture of the possible etiology where a different
reported principal diagnosis would signal the need for therapy.
Furthermore, we received comments on this particular diagnosis stating
that while there are diagnosis codes for dysphagia resulting from a
cerebrovascular event (for example, stroke) and others resulting from
somatoform disorders (for example, psychogenic dysphagia), there are
very few disease-specific diagnosis codes to identify associated
dysphagia (for example, dysphagia resulting from throat cancer
treatment). A review of the CY 2020 ICD-10-CM official code set tabular
index, showed that the majority of codes to describe dysphagia are the
R13 codes. We recognize that dysphagia codes associated with a
cerebrovascular event would be assigned to the Neuro Rehab clinical
group and commenters stated that those patients with dysphagia due to
etiologies not associated with cerebrovascular events would most often
require speech-language pathology therapy if the primary reason for
home health services is for the dysphagia. Given the current lack of
other definitive diagnoses to describe certain forms of dysphagia, we
agree that the R-codes to describe dysphagia would be acceptable for
reporting the primary reason for home health services. Therefore, we
will assign the following R-codes to the Neuro Rehab clinical group:
R13.10, Dysphagia, unspecified
R13.11, Dysphagia, oral phase
R13.12, Dysphagia, oropharyngeal phase
R13.13 Dysphagia, pharyngeal phase
R13.14, Dysphagia, pharyngoesophageal phase
R13.19, Other dysphagia
While we understand that dysphagia could be the result of non-
neurological conditions, we are assigning these dysphagia groups to the
Neuro Rehab group as we believe the intensity of speech-language
pathology therapy would be similar to those suffering from dysphagia
resulting from a neurological condition. However, we will monitor the
use of these dysphagia R-codes to determine their impact on resources
utilization and whether any future changes would be warranted.
Finally, we remind commenters that ICD-10-CM coding guidelines
state that codes for signs and symptoms may be reported in addition to
a related definitive diagnosis when the sign or symptom is not
routinely associated with that diagnosis, such as signs and symptoms
associated with complex syndromes. The definitive diagnosis should be
sequenced before the symptom code. Signs or symptoms that are
associated routinely with a disease process should not be assigned as
secondary codes, unless otherwise instructed by the classification.
Therefore, we expect that HHAs would report the principal and secondary
diagnoses that affect the home health plan of care and justify the need
for home health services.
Comment: We received specific coding comments from national
industry associations as well as well as from other HHAs, with
recommendations to change or add the following codes to the clinical
group variable.
Response: Table 12 lists these codes and the commenters recommended
clinical group, as well as our response to these recommendations:
BILLING CODE 4120-01-P
[[Page 60502]]
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[[Page 60503]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.013
[[Page 60504]]
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[[Page 60505]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.015
[[Page 60506]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.016
[[Page 60507]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.017
[[Page 60508]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.018
BILLING CODE 4120-01-C
[[Page 60509]]
We note that as we were examining the clinical group changes
suggested by commenters, we took the opportunity to ensure consistency
in the clinical group assignments and have reassigned certain diagnosis
codes accordingly. Specifically, we are reassigning the following
codes:
[GRAPHIC] [TIFF OMITTED] TR08NO19.019
[[Page 60510]]
Comment: Several commenters stated that code M62.81 Muscle Weakness
(generalized) should be allowed to be reported as the principal
diagnosis used to assign a clinical group. Commenters stated that it is
problematic to exclude this code, as there are scenarios in which
patients are seen in the home for muscle weakness when the underlying
etiology is unknown, or when the original condition, causing the
weakness is resolved. Additionally, commenters noted that M62.81 is
identified as a diagnostic code to support medical necessity for home
health therapy services by the MACs within their local coverage
determinations. While commenters agreed that this diagnosis lacks
specificity, they stated that they disagree that this diagnosis would
not be deemed medically necessary. And finally, commenters stated that
when evaluating the assignation of a diagnosis code at the point of
care in home health, the coding specialist must consider the available
documentation.
Response: As we stated in the CY 2019 HH PPS final rule with
comment period (83 FR 56474), M62.81, ``Muscle weakness, generalized''
is a vague code that does not clearly support a rationale for skilled
services. Further, the lack of specificity for this code does not
support a comprehensive plan of care. We noted that Sec.
409.44(c)(1)(ii) states that ``the patient's clinical record must
include documentation describing how the course of therapy treatment
for the patient's illness or injury is in accordance with accepted
professional standards of clinical practice.'' If there is not an
identified cause of muscle weakness, then it would be questionable as
to whether the course of therapy treatment would be in accordance with
accepted professional standards of clinical practice.
Additionally, it is not without precedent that CMS has been
disinclined to include generalized muscle weakness in the home health
case-mix. In the 2008 HH PPS final rule, we identified generalized
muscle weakness as a nonspecific condition that represents general
symptomatic complaints in the elderly population. We stated that
inclusion of this code ``would threaten to move the case-mix model away
from a foundation of reliable and meaningful diagnosis codes that are
appropriate for home care'' (72 FR 49774). The 2008 HH PPS final rule
stated that the case-mix system avoid, to the fullest extent possible,
non-specific or ambiguous ICD-9-CM codes, codes that represent general
symptomatic complaints in the elderly population, and codes that lack
consensus for clear diagnostic criteria within the medical community.
Expanding upon that assertion, we stated in the CY 2019 final rule with
comment period that diagnostic approaches to determining the cause of
muscle weakness, polyneuropathy, and other vague conditions, combined
with the expanded ICD-10 list, ensure that codes exist which more
clearly describe a patient's need for home health (83 FR 56474). With
respect to commenter rationale for coding generalized muscle weakness
when the underlying etiology is unknown, we believe that by the time a
home health referral is made, a more definitive principal diagnosis is
warranted in order to justify the need for skilled services and
appropriate treatment. Further, if the original condition is resolved,
but the resulting muscle weakness persists as a result of the known
original diagnosis, we anticipate that a more specific code exists that
accounts for why the muscle weakness is on-going, such as muscle
wasting or atrophy. As the commenter pointed out, the coding specialist
must consider available documentation; however, as we state in the
previous discussion regarding symptom codes, we believe it is important
for a clinician to investigate the reason for which the referral was
made. This may involve calling the referring physician if the original
condition is resolved and is not included in the referral
documentation.
With respect to commenter reference to the LCD for Physical Therapy
in Home Health (L33942), we recognize that M62.81 is identified as a
code to support medical necessity. While we are not disputing that
services for this diagnosis are considered reasonable and medically
necessary, we do not believe it is appropriate to list Muscle weakness,
generalized as a principal diagnosis in order to group the home health
period. We developed the clinical groupings in large part to clearly
identify the need for the home health episode, including the skilled
services involved. Allowing use of a vague code that does not clearly
denote a treatment plan, would invalidate the transparency we hope to
achieve in the home health payment system.
6. Comorbidities
Comment: A commenter questioned why the list of comorbidity codes
stopped at the R codes and indicated there should be codes for
``traumas, postoperative complications and the Z codes''. The same
commenter questioned why some codes were included in the overall
comorbidity list but not all were eligible for a comorbidity
adjustment. A commenter requested an explanation the rationale for not
including any conditions from the ICD-10-CM chapters with O, P, Q, R,
S, T, or Z codes as comorbidity diagnoses as many of these seem
appropriate given the significant impact these conditions have on the
patient's recovery.
Another commenter questioned why blindness and other low vision
codes (Neuro 11) were removed from the comorbidity grouping given their
significance in patient treatment and recovery.
Response: As we described in the CY 2018 HH PPS proposed rule (82
FR 35322), we examined multiple approaches for a comorbidity adjustment
in the alternate case-mix adjustment methodology and the analyses on
these approaches are found in the ``Overview of the Home Health
Groupings Model'' technical report found on the HHA Center web page. As
we noted in the technical report, secondary diagnosis reporting on the
OASIS and home health claims was not as robust as would be expected. As
part of that analysis, we also examined claims from prior settings 90
days before the home health start of each home health episode. Again,
our analysis showed that diagnosis reporting was not as robust as
hypothesized, especially in Part B physician claims where diagnoses
reported appeared to be specific to only the condition for which the
patient sought care. Furthermore, many secondary diagnosis codes,
including those associated with signs, symptoms, and other ill-defined
conditions (that is, R-codes) often had an inverse relationship with
resource use, meaning the presence of these symptom codes showed less
resource use for home health periods of care. Based on the results of
these analyses, we proposed and finalized a home health specific
comorbidity list for the PDGM comorbidity adjustment, as described in
the technical report and in the CY 2018 and CY 2019 HH PPS proposed and
final rules. The home health-specific comorbidity list is based on the
principles of patient assessment by body systems and their associated
diseases, conditions, and injuries to develop larger categories of
conditions that identified clinically relevant relationships associated
with increased resource use. While we are aware of the prevalence of
comorbidities, including those associated with symptoms, in the
Medicare home health population, we note that the average number of
comorbidities in the aggregate becomes the standard within that
population for the purpose of payment. As such, the PDGM comorbidity
adjustment includes
[[Page 60511]]
those comorbid conditions and interaction subgroups that represent more
than 0.1 percent of periods and that have at least as high as the
median resource use. While there are additional comorbid diagnoses
included in the home health-specific list, we note that not all
diagnoses are included in a comorbidity subgroup that meets the
criteria to receive an adjustment. However, it is expected that HHAs
will report those secondary diagnoses that affect care planning and we
will continue to evaluate reported secondary diagnoses and interactions
between comorbidities to identify their impact on resource costs to
determine if any future refinements to this case-mix adjustment
variable are warranted.
Regarding the exclusion of diagnosis codes from the ICD-10-CM
chapters starting with ``O'', ``P'', or ``Q'', we note that these are
diagnosis codes that reflect conditions of pregnancy, childbirth and
the puerperium (O00-O9A),certain conditions originating in the
perinatal period (P00-P96), and congenital malformations, deformations,
and chromosomal abnormalities (Q00-Q99). As such, because we were
examining reported diagnoses on Medicare home health claims, these were
diagnoses that were not generally reported given the nature of the
Medicare patient population. Secondary diagnosis codes identifying
signs, symptoms and other ill-defined conditions (R-codes, R00-R99)
were examined as part of our analysis for possible inclusion on the
comorbidity list, however, these generally did not show any significant
correlation on resource use and therefore were not included in the home
health specific comorbidity diagnosis list. We note, however, that
R00.1, bradycardia, unspecified, is on the comorbidity diagnosis list
and is included under the comorbidity subgroup, Heart 10, which does
meet the comorbidity adjustment criteria and receives additional
payment. The same holds true with the codes that begin with ``S'' or
``T'', representing injury, poisoning, and certain other consequences
of external causes (S00-T88) where these codes were not frequently
reported as secondary diagnoses on home health claims. Furthermore, we
described in detail, in the CY 2018 proposed rule (82 FR 35322), how we
developed the home health specific comorbidity diagnosis list, focusing
on those chronic conditions that our literature review, and our data
analysis, showed to be clinically and statistically significant on
their overall impact on home health resource use. Finally, we note that
there are diagnosis codes representing blindness and other low-vision
conditions on the home health specific comorbidity list (the Neuro 11
subgroup). However, when analyzing CY 2018 home health claims for the
CY 2020 comorbidity adjustment, these particular diagnosis codes did
not represent more than 0.1 percent of periods or have at least as high
as the median resource use and therefore, will not receive a
comorbidity adjustment in CY 2020. We take this opportunity to remind
commenters that there are diagnosis codes on the home health specific
list that will not receive the adjustment in CY 2020, but that does not
mean that these would never receive an adjustment. Based on our
extensive literature review and previous comments received on what
clinically significant secondary diagnoses to include as part of this
home health specific list, we believe that if HHAs are reporting these
as secondary diagnoses and they have an impact on home health resource
use (that is, represent more than 0.1 percent of home health periods of
care and have at least as high as the medial resource use), these
diagnoses could receive a comorbidity payment adjustment in future
years. As such, the comorbidity subgroups that could receive an
adjustment in any given year is fluid, depending on the frequency of
the reported codes and their impact on resource use. Therefore, we
remind commenters of the importance of reporting secondary diagnoses on
the home health claim, regardless of whether there is a comorbidity
payment adjustment associated with such diagnosis. Likewise, we will
continue to examine reported secondary diagnoses on home health claims
and their relationship with resource use to determine whether such
diagnoses should be included on the home health specific comorbidity
list in future years.
Comment: A few commenters noted that there are separate
instructions for reporting other/secondary diagnoses on the claim, the
OASIS instructions, the CoPs and the interpretive guidelines. These
commenters recommended that CMS modify all of these instructions with
ICD-10-CM coding guidelines to be consistent with the expectations for
reporting of diagnoses.
Response: The ICD-10-CM coding guidelines \13\ define ``other''
(additional) diagnoses as ``all conditions that coexist at the time of
admission, that develop subsequently, or that affect the treatment
received and/or the length of stay.'' The OASIS manual instructions
\14\ state that ``secondary diagnoses are comorbid conditions that
exist at the time of the assessment, that are actively addressed in the
patient's plan of care, or that have the potential to affect the
patient's responsiveness to treatment and rehabilitative prognosis''.
The CoPs at Sec. 484.60 state that the home health plan of care must
include all ``pertinent diagnoses'' and the accompanying interpretive
guidelines state that this means that all ``known diagnoses''. While we
recognize that there could be a perceived difference between the
various descriptions, we believe that these instructions essentially
describe the same thing. Specifically, all of these coding instructions
state to include any conditions that exist at the time of home health
admission, or that develop during the course of a home health period of
care, and that affect patient care planning. That is, diagnoses should
be reported that affect or potentially affect patient care (and
therefore would be addressed in the home health plan of care), even if
such care includes observation and assessment (for actual or potential
effects), teaching and training, or direct patient care interventions.
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\13\ ICD-10-CM Official Guidelines for Coding and Reporting FY
2020. https://www.cdc.gov/nchs/data/icd/10cmguidelines-FY2020_final.pdf.
\14\ ``Outcome and Assessment Information Set OASIS-D Guidance
Manual'', Effective January 1, 2019 https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/draft-OASIS-D-Guidance-Manual-7-2-2018.pdf.
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Final Decision: We note that the PDGM was finalized in the CY 2019
HH PPS final rule with comment period (83 FR 56406), and therefore, no
structural changes to this case-mix adjustment methodology have been
made in this CY 2020 final rule with comment period. Therefore, we are
finalizing the implementation of the PDGM for 30-day periods of care
beginning on and after January 1, 2020. We are finalizing the coding
changes for the clinical group as described in responses to the various
diagnosis/clinical group comments. These coding changes will be
reflected in the Interactive Grouper Tool posted on the HHA Center web
page and also in the downloadable HH PPS grouper \15\ that accompanies
the publication of this final rule with comment period.
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\15\ Home Health PPS Software web page. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/CaseMixGrouperSoftware.html.
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B. Implementation of a 30-Day Unit of Payment for CY 2020
Under section 1895(b)(3)(A)(iv) of the Act, we are required to
calculate a 30-day payment amount for CY 2020 in a budget-neutral
manner such that
[[Page 60512]]
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 payment. Section 1895(b)(3)(A)(iv) of the Act also
requires that in calculating a 30-day payment amount in a budget-
neutral manner the Secretary must make assumptions about behavior
changes that could occur as a result of the implementation of the 30-
day unit of payment. In addition, in calculating a 30-day payment
amount in a budget-neutral manner, we must take into account behavior
changes that could occur as a result of the case-mix adjustment factors
that are implemented in CY 2020. We are also required to calculate a
budget-neutral 30-day payment amount before the provisions of section
1895(b)(3)(B) of the Act are applied; that is, before the home health
applicable percentage increase, the adjustment if quality data are not
reported, and the productivity adjustment.
In the CY 2019 HH PPS final rule with comment period (83 FR 56461),
we finalized three assumptions about behavior changes that could occur
in CY 2020 as a result of the implementation of the 30-day unit of
payment and the implementation of the PDGM case-mix adjustment
methodology:
Clinical Group Coding: A key component of determining
payment under the PDGM is the 30-day period of care's clinical group
assignment, which is based on the principal diagnosis code for the
patient as reported by the HHA on the home health claim. Therefore, we
assume that HHAs will change their documentation and coding practices
and would put the highest paying diagnosis code as the principal
diagnosis code in order to have a 30-day period of care be placed into
a higher-paying clinical group. While we do not support or condone
coding practices or the provision of services solely to maximize
payment, we often take into account in proposed rules the potential
behavior effects of policy changes should they be finalized and
implemented based on past evidence and as detailed in the CY 2020
proposed and this final rule with comment period.
Comorbidity Coding: The PDGM further adjusts payments
based on patients' secondary diagnoses as reported by the HHA on the
home health claim. While the OASIS only allows HHAs to designate 1
primary diagnosis and 5 secondary diagnoses, the home health claim
allows HHAs to designate 1 principal diagnosis and 24 secondary
diagnoses. Therefore, we assume that by taking into account additional
ICD-10-CM diagnosis codes listed on the home health claim (that exceed
the 6 allowed on the OASIS), more 30-day periods of care will receive a
comorbidity adjustment than periods otherwise would have received if we
only used the OASIS diagnosis codes for payment. The comorbidity
adjustment in the PDGM can increase payment by up to 20 percent.
LUPA Threshold: Rather than being paid the per-visit
amounts for a 30-day period of care subject to the low-utilization
payment adjustment (LUPA) under the PDGM, we assume that for one-third
of LUPAs that are 1 to 2 visits away from the LUPA threshold, HHAs will
provide 1 to 2 extra visits to receive a full 30-day payment.\16\ LUPAs
are paid when there are a low number of visits furnished in a 30-day
period of care. Under the PDGM, the LUPA threshold ranges from 2-6
visits depending on the case-mix group assignment for a particular
period of care (see section III.D. of this final rule with comment
period for the LUPA thresholds that correspond to the 432 case-mix
groups under the PDGM).
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\16\ Current data suggest that what would be about \1/3\ of the
LUPA episodes with visits near the LUPA threshold move up to become
non-LUPA episodes. We assume this experience will continue under the
PDGM, with about \1/3\ of those episodes 1 or 2 visits below the
thresholds moving up to become non-LUPA episodes.
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For this final rule with comment period, in order to calculate the
CY 2020 budget neutral 30-day payment amounts both with and without
behavior assumptions, we first calculated the total, aggregate amount
of expenditures that would occur under the current case-mix adjustment
methodology (as described in section III.C. of this rule) and the 60-
day episode unit of payment using the CY 2019 payment parameters (for
example, CY 2019 payment rates, case-mix weights, and outlier fixed-
dollar loss ratio). That resulted in a total aggregate expenditures
target amount of $16.6 billion.\17\ We then calculated what the 30-day
payment amount would need to be set at in CY 2020, with and without
behavior assumptions, while taking into account needed changes to the
outlier fixed-dollar loss ratio under the PDGM in order to pay out no
more than 2.5 percent of total HH PPS payments as outlier payments
(refer to section III.F. of this rule) and in order for Medicare to pay
out $16.6 billion in total expenditures in CY 2020 with the application
of a 30-day unit of payment under the PDGM. Table 14 includes the 30-
day budget-neutral payment amount for CY 2020 both with and without the
behavior assumptions based on the most current data available at the
time of this final rule with comment period. These amounts vary
slightly from those in Table 12 of the proposed rule (84 FR 34616) due
to using more up-to-date data. These payment amounts do not include the
CY 2020 home health payment update of 1.5 percent.
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\17\ The final 2018 analytic file included 6,3388,974 60-day
episodes ($18.0 billion in total expenditures as shown on the
claim). Of these, 609,947 (9.5 percent) were excluded because they
could not be linked to OASIS assessments or because of the claims
data cleaning process reasons listed in section III.F.1 of this
rule. We note that of the 609,947 excluded claims, 142,206 were
excluded because they were RAPs without a final claim or they were
claims with zero payment amounts, resulting in $17.9 billion in
total expenditures (as shown on the claim). After removing all
609,947 excluded claims, the 2018 analytic file consisted of
5,779,027 60-day episodes ($16.6 billion in total expenditures ass
shown on the claim). 60-day episodes of duration longer than 30 days
were divided into two 30-day periods in order to calculate the 30-
day payment amounts. As noted in section III.F.1 of this rule, there
were instances where 30-day periods were excluded from the 2018
analytic file (for example, we could not match the period to a start
of care or resumption of care OASIS to determine the functional
level under the PDGM, the 30-day period did not have any skilled
visits, or because information necessary to calculate payment was
missing from claim record). The final 2018 analytic file used to
calculate budget neutrality consisted of 9,336,898 30-day periods
($16.6 billion in total expenditures that are simulated under the
PDGM) drawn from 5,471,454 60-day episodes.
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[[Page 60513]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.020
If no behavior assumptions were made, we estimate that the CY 2020
30-day payment amount needed to achieve budget neutrality would be
$1,908.18. Applying the clinical group and comorbidity coding
assumptions, and the LUPA threshold assumption, as required by section
1895(b)(3)(A)(iv) of the Act, would result in the need to decrease the
CY 2020 budget-neutral 30-day payment amount to $1,748.11 (an 8.389
percent decrease from $1,908.18). The CY 2020 estimated 30-day budget-
neutral payment amount would be slightly less than the CY 2019
estimated 30-day budget-neutral payment amount calculated in last
year's rule (that is, if the PDGM was implemented in CY 2019), which we
estimated to be $1,753.68. However, the CY 2019 estimated 30-day
payment amount of $1,753.68 included the CY 2019 market basket update
of 2.1 percent whereas the CY 2020 estimated 30-day budget neutral
payment amount of $1,748.11 does not include the 1.5 percent home
health legislated payment update for CY 2020. Applying the CY 2020 Wage
Index Budget Neutrality Factor and the 1.5 percent home health update
as described in section III.E. of this final rule with comment period)
would increase the CY 2020 national, standardized 30-day payment amount
to $1,785.51. The CY 2020 estimated payment rate of $1,785.51 is
approximately 11 percent more than the estimated CY 2020 30-day period
cost of $1,608.82, as shown in Table 5 of this final rule with comment
period.
The 30-day payment amount will be for 30-day periods of care
beginning on and after January 1, 2020. Because CY 2020 is the first
year of the PDGM and the change to a 30-day unit of payment, there will
be a transition period to account for those home health episodes of
care that span the implementation date. Therefore, for 60-day episodes
(that is, not LUPA episodes) that begin on or before December 31, 2019
and end on or after January 1, 2020 (episodes that would span the
January 1, 2020 implementation date), payment made under the Medicare
HH PPS will be the CY 2020 national, standardized 60-day episode
payment amount as described in section III.E.4.b of this final rule
with comment period. For home health periods of care that begin on or
after January 1, 2020, the unit of service will be a 30-day period and
payment made under the Medicare HH PPS will be the CY 2020 national,
standardized prospective 30-day payment amount as described in section
III.E.4.d. of this final rule with comment period. For home health
units of service that begin on or after December 3, 2020 through
December 31, 2020 and end on or after January 1, 2021, the HHA will be
paid the CY 2021 national, standardized prospective 30-day payment
amount.
We note that we are also required under section 1895(b)(3)(D)(i) of
the Act, as added by section 51001(a)(2)(B) of the BBA of 2018, to
analyze data for CYs 2020 through 2026, after implementation of the 30-
day unit of payment and new case-mix adjustment methodology, to
annually determine the impact of differences between assumed behavior
changes and actual behavior changes on estimated aggregate
expenditures. We interpret actual behavior change to encompass both
behavior changes that were previously outlined, as assumed by CMS when
determining the budget-neutral 30-day payment amount for CY 2020, and
other behavior changes not identified at the time the 30-day payment
amount for CY 2020 is determined. We noted in the proposed rule that
complete data from CYs 2020 through 2026 will be available to determine
whether a prospective adjustment (increase or decrease) is needed no
earlier than in years 2022 through 2028 rulemaking. However, we noted
that we would analyze preliminary data after implementation of the PDGM
to determine if there are any notable and consistent trends to warrant
whether any changes to the national, standardized 30-day payment rate
should be done earlier than CY 2022.
As noted previously, under section 1895(b)(3)(D)(ii) of the Act, we
are required to provide one or more permanent adjustments to the 30-day
payment amount on a prospective basis, if needed, to offset increases
or decreases in estimated aggregate expenditures as calculated under
section 1895(b)(3)(D)(i) of the Act. Clause (iii) of section
1895(b)(3)(D) of the Act requires the Secretary to make temporary
adjustments to the 30-day payment amount, on a prospective basis, in
order to offset increases or decreases in estimated aggregate
expenditures, as determined under clause (i) of such section. The
temporary adjustments allow us to recover excess spending or give back
the difference between actual and estimated spending (if actual is less
than estimated) not addressed by permanent adjustments. However, any
permanent or temporary adjustments to the 30-day payment amount to
offset increases or decreases in estimated aggregate expenditures as
calculated under section 1895(b)(3)(D)(i) and (iii) of the Act would be
subject to notice and comment rulemaking.
We reiterate that if CMS underestimates the reductions to the 30-
day payment amount necessary to offset behavior changes and maintain
budget neutrality, larger adjustments to the 30-day payment amount
would be required in the future, by law, to ensure budget neutrality.
Likewise, if CMS
[[Page 60514]]
overestimates the reductions, we are required to make the appropriate
payment adjustments accordingly as described previously.
We solicited comments on the proposed, estimated CY 2020 30-day
budget neutral payment amount, as well as any potential issues that may
result from taking these behavior assumptions into account when
establishing the initial 30-day payment amounts for CY 2020. We did not
propose any changes to the behavior assumptions finalized in the CY
2019 HH PPS final rule with comment period (83 FR 56461). We received
186 comments on the behavior assumptions finalized in the CY 2019 HH
PPS final rule with comment period and the proposed 30-day payment
amount for CY 2020 from various stakeholders including home health
agencies, industry associations, individual clinicians, and MedPAC.
These comments and our responses are summarized in this section of this
final rule with comment period.
Comment: Several commenters disagreed with the behavior assumptions
finalized in the CY 2019 HH PPS final rule with comment period.
Commenters added that given the current regulatory and audit
environment, agencies who are coding diagnoses strictly for payment
maximization must still keep their focus of care as the primary
consideration in coding or their payments will be denied. Commenters
went on to state that the home health agency can only code what is
already in the medical record and that has been diagnosed by a
physician, so there is a limit to which diagnoses may be selected. A
commenter stated that CMS is creating an environment wherein agencies
will have to modify their coding practices in order to survive. This
commenter stated HHAs that would not normally alter their behavior
without the reduction will now be forced to.
Response: We continue to believe that the behavior assumptions are
reasonable given past experience with changes in provider behavior in
response to payment system modifications. We refer readers to the CY
2019 HH PPS final rule with comment period (83 FR 56456), in which we
provided examples of observed behavior changes resulting from payment
system changes. These examples included the behavior changes resulting
from the transition from diagnosis-related groups (DRGs) and the
Medicare Severity (MS)-DRGs under the inpatient prospective payment
system, and nominal case-mix growth observed from the 2008 changes to
the HH PPS case-mix model that resulted in the current 153 home health
resource groups. We also believe that there may be additional behavior
changes that may result from the change to a new case-mix adjustment
methodology that relies more heavily on patient characteristics. For
example, given the significant number of ICD-10-CM diagnosis codes that
are assigned to a clinical group, HHAs may start reporting diagnoses
that were not typically reported on home health claims under the
current 153-group model. As we stated in the CY 2020 HH PPS proposed
rule (84 FR 34614), we do not support or condone coding practices or
the provision of services solely to maximize payment. We fully expect
that HHAs would report those diagnoses (both the principal diagnosis
and secondary diagnoses) that reflect the primary reason for home
health services and those that affect the home health plan of care.
This is in accordance with ICD-10-CM coding guidelines, which state to
select the principal diagnosis code that reflects the reason for the
health care encounter, and to report the additional diagnoses that
affect patient care in terms of clinical evaluation, therapeutic
treatment, and increased nursing care or monitoring. Furthermore, the
specificity and granularity of ICD-10-CM diagnosis codes provide the
opportunity for HHAs to improve their diagnosis code reporting to more
accurately reflect the reason for home health services and other
conditions that affect the home health plan of care. If the supporting
documentation from the certifying physician or the acute/post-acute
care facility is lacking specificity regarding the patient's diagnoses,
the HHA would be expected to query such providers in order to
adequately address the patient's home health care needs.
Because one of the variables in the PDGM case-mix adjustment is the
clinical grouping, we believe that HHAs would be more comprehensive in
their assessment of the patient to identify all diagnoses to determine
the individualized patient care needs to be addressed through the home
health plan of care. More specific and accurate diagnosis reporting to
identify those conditions affecting the home health plan of care and to
support the need for services is appropriate. Likewise, the home health
Conditions of Participation (CoPs) at Sec. 484.60(a), require that the
home health plan of care includes all pertinent diagnoses. HHAs are
required to consult the physician if there are any additions or
modifications to the plan of care. Therefore, any diagnoses included on
the home health plan of care would have to be agreed upon by the
physician responsible for the home health plan of care. More accurate
and complete reporting of diagnoses is not inappropriate if in
accordance with existing regulations and standards of practice.
Modification of current coding practices does not mean that HHAs are
engaging in inappropriate behavior nor are the coding assumptions meant
to encourage any type of negative behavior change. As noted previously,
ICD-10-CM diagnosis codes are granular and specific, and provide HHAs a
better opportunity to report those codes that reflect the patient's
conditions and support the need for home health services. We view
improved diagnosis reporting as a positive change that affords HHAs the
latitude to fully ``paint the picture'' of their patients receiving
home health services.
Comment: Many commenters stated that the behavior assumptions
finalized are ``faulty'' with no empirical evidence to support such
assumptions or that the behaviors would actually occur. Most often,
commenters stated that while changes in coding behavior may occur, the
degree to which this may occur and the impact of the occurrence,
especially in the first year of the new payment system seems to be
exaggerated by CMS. Several commenters stated that their home health
agencies do not ``game the system'' and base patients' care plans on
what patients need. These commenters believe that they should not be
subjected to payment cuts based on Medicare's assumptions, which they
believe to be flawed. A few commenters stated that the behavior
assumptions penalize those agencies who have been providing care based
on patient need and not driven by therapy utilization or other
behaviors solely to maximize payment. These commenters indicated that
they would not change their current care practices because of this
regulation and that they were essentially being punished for doing the
right thing all along. They expressed concern over how they would
adjust to compensate for an 8 percent reduction in the 30-day payment
rate. Other commenters recommended that CMS establish monitoring
programs to target providers engaging in in specific behaviors solely
for payment purposes rather than ``penalize all providers.'' Several
comments indicated that the behavioral assumptions are a punitive
action against all home health agencies based on behaviors that have
not happened yet and may never happen.
Response: We disagree that the finalized behavior assumptions are
without empirical evidence as we have provided multiple examples of
previous changes in behavior in response to payment changes, especially
as they
[[Page 60515]]
relate to coding behavior. In the CY 2020 HH PPS proposed rule (83 FR
56456), we provided examples of such evidence. For the clinical group
and comorbidity assumptions when CMS implemented revisions to the home
health case-mix system in 2008, subsequent analysis found that
behavioral responses unrelated to patient severity caused payments to
increase by 4 percent in that year--despite having increased only 1
percent per year, on average, between 2001 and 2007. CMS continued to
find nominal increases in case mix unrelated to patient severity in
later years and reduced payments by an average of 1.8 percent a year
from 2008 through 2017 to account for this trend. We refer commenters
to the impact of the coding and comorbidity assumptions in Table 14 of
this rule, which is estimated to be 6.4 percent and 0.25 percent
respectively, which is similar to other past coding behavior responses
described previously and which were associated with the implementation
of a new home health payment system.
We also provided additional examples from other Medicare payment
systems where coding behaviors led to increases in payment not
necessarily related to increases in patient acuity. These include the
transition from DRGs to (MS) DRGs; the first year of the IRF PPS; and
Maryland's transition to APR DRGs. For the LUPA assumptions, we
provided the analysis of the implementation of the HH PPS where the
expected rate of LUPAs (16 percent) was much higher than the actual
rate of LUPAs (7 percent), indicating that HHAs were providing extra
visits to receive a full 60-day episode case-mix adjusted payment
amount.
Additionally, section 1895(b)(3)(A)(iv) of the Act requires us to
make assumptions about behavior changes that could occur as a result of
the change to a 30-day unit of payment and implementation of the PDGM
when calculating a 30-day payment amount in a budget-neutral manner.
These assumptions are not to account for ``gaming'' of the system as
commenters suggest, and we stated as such in the CY 2019 HH PPS
proposed rule (83 FR 56455). We clarified that CMS often takes into
account anticipated behaviors when making a payment system change. By
including behavior change assumptions in the proposed calculation of
the 30-day payment amount, as required by statute, we did not intend to
imply that HHAs would engage in unethical behavior. Furthermore in the
CY 2019 HH PPS final rule with comment period (83 FR 56455), we
provided detailed explanation as to why we believe that targeted
actions against specific providers who may or may not be engaging in
abusive coding patterns would not be effective. Explicitly, we stated
that system-wide case-mix levels have risen over time throughout the
country, while patient characteristics data indicate little real change
in patient severity over that same time. These widespread changes make
it challenging to clearly separate agencies into high and low coding
change groups. While we do not believe that our overall assumptions are
exaggerated, we also recognize commenter concern over the frequency of
these behaviors during the first year of the payment changes.
Finally, in the CY 2019 HH PPS final rule with comment period (83
FR 56455), we stated that the behavior assumption adjustment is not
meant to be punitive, rather we are required by law to make such
assumptions when calculating the 30-day budget-neutral payment amount.
MedPAC comments on the CY 2020 HH PPS proposed rule support the
finalized behavior assumptions and it states that even with the
behavior assumption adjustment, payment would still exceed estimated
costs. MedPAC went on to state that most HHAs will be able to absorb
the 8.01 percent adjustment.
Comment: A few commenters asserted that such behavior assumptions
are not applied to other settings, should not be applied to home care,
and applying behavior assumptions absent supporting data is not sound
payment policy. Specifically, these commenters mention that CMS, in
issuing the Skilled Nursing Facility (SNF) model, refused to make
assumptions about provider behavior, stating that it would ``not make
any attempt to anticipate or predict provider reactions to the
implementation of the proposed [payment model].''
Response: We remind commenters that CMS is required, by statute, to
make assumptions about behavior changes that could occur as a result of
the implementation of the 30-day unit of payment and the PDGM when
calculating the 30-day payment amount in a budget neutral manner for CY
2020. Other new payment models, such as the Patient-Driven Payment
Model for skilled nursing facilities did not have such a statutory
requirement. In compliance with section 1895(b)(3)(A)(iv) of the Act,
we believe that we have made reasonable assumptions about what behavior
changes to expect with the implementation of the new home health PPS
payment structure which are based on previous experience with the HH
PPS, as well as other payment systems.
Comment: A commenter stated that there is no evidence to support
the clinical group coding assumption. This commenter referenced the
analysis of home health improper payments in the CMS 2017 Fee-for-
Service Supplemental Improper Payment Data Report \18\ stating improper
payments due to incorrect coding was zero dollars.
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\18\ 2017 Medicare Fee-for-Service Supplemental Improper Payment
Data. https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/Downloads/2017-Medicare-FFS-Improper-Payment.pdf.
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Response: We note that CMS uses the Comprehensive Error Rate
Testing (CERT) Program to estimate the Medicare Fee-For-Service (FFS)
improper payment rate. The purpose of the CERT Program is to identify
payments that should not have been made or payments made in an
incorrect amount. Under the CERT Program, the definition of ``incorrect
coding'' in the context of the home health improper payments, relates
to incorrect HIPPS codes on HH claims, meaning that medical
documentation supports different coding than what was billed; that the
service was performed by someone other than the billing provider; that
the billed service was unbundled; and that a beneficiary was discharged
to a site other than the one coded on a claim.\19\ For example, an
improper payment is made as a result of the HIPPS code reflecting a
therapy threshold not supported by entries in the medical record.
Therefore, contrary to the commenter's remark, improper home health
payments resulting from incorrect coding does not relate to diagnosis
codes reported, rather it relates to the reported HIPPS code on home
health claims. We note that the most common type of improper payment
error in home health is ``insufficient documentation''. This occurs
when: There is missing or inadequate medical records; there is a
missing certification or recertification or some element of the
certification or recertification is missing; there are missing or
inadequate orders; there are inconsistent records; there is a missing
or inadequate plan of care; or there are multiple universal errors. For
home health, ``insufficient documentation'' often means that the home
health certification requirements, in entirety or an element, have not
been submitted. Therefore, the analysis regarding the home health
improper payments is not evidence to negate the clinical coding
[[Page 60516]]
assumption. We remind commenters that our position on the coding
behavior assumption is that we assume that HHAs will improve their
documentation and coding behaviors to more fully account for patient
characteristics that impact resource use.
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\19\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/Downloads/IntroductiontoComprehensiveErrorRateTesting.pdf.
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Comment: A commenter supported the comorbidity assumption and
stated that prior to this proposal, there was no motivation to code all
of the patient's comorbidities and that under the PDGM, HHAs will have
the motivation to document all conditions that affect patient care.
This commenter stated that this would be a positive change in that it
gives a more complete picture of acuity for the patients being cared
for by the HHA and would demonstrate that HHAs are caring for very
complex, chronically ill patients and perhaps keeping these patients
out of more costly care settings.
Response: We agree with this commenter that the availability to
report more secondary diagnoses on the home health claim would provide
home health agencies with the opportunity to more comprehensively
portray all of the comorbidities affecting the home health plan of
care. We believe this will benefit HHAs in terms of receiving a payment
adjustment to account for the services being provided to address such
comorbidities.
Comment: MedPAC noted that the proposed payment reduction of 8.01
percent appears to be consistent with past trends in coding that CMS
has reported and supported the behavioral assumptions. MedPAC also
commented that the proposed behavior adjustment may not represent all
of the behavioral changes that could occur. Specifically, MedPAC
suggested that agencies could respond to the new 30-day unit of payment
by providing additional visits after an initial 30-day period to
trigger an additional 30-day payment, which could result in higher
aggregate payments and that CMS should reduce payments to reflect this
excess.
Response: We thank MedPAC for their comments. We agree that there
may be other behavior changes that could result from a new case-mix
system and a change in the unit of payment, including the behavior
MedPAC describes. However, we are not adding a prospective adjustment
to account for this additional potential behavior change for CY 2020 as
we believe that the behavior changes finalized in the CY 2019 final
rule with comment period are the ones best supported based on our
experience with changes to payment systems for home health and other
provider types. As required by the statute, we will analyze data for
CYs 2020 through 2026 to annually determine the impact of differences
between assumed behavior changes and actual behavior changes on
estimated aggregate expenditures. This means, we would examine all
behavior changes and not just those assumed to determine their impact
on overall expenditures. CMS, at a time and in a manner appropriate, is
required to determine whether the 30-day payment amounts needs to be
increased or decreased in response to actual observed behavior change.
We interpret actual observed behavior change to encompass both behavior
changes that were previously outlined, as assumed by CMS when
calculating the budget-neutral 30-day payment amount for CY 2020, and
other behavior changes not identified at the time the 30-day payment
amount for CY 2020 is determined.
Comment: Several commenters requested CMS provide expected total
aggregated budget neutral HH PPS expenditures for future years and
requested to further understand how the cases dropped from PDGM would
be accounted for in the budget neutrality calculations. Another
commenter stated that all existing work papers on the PDGM behavior
adjustment by any party within CMS, including the Office of the
Actuary, should be made readily available to the public through the CMS
website. These comments express significant concerns that the dropped
claims violate the Jimmo vs. Sebelius settlement agreement by excluding
them from the analysis and not recognizing the patient needs in PDGM.
Another commenter recommends that CMS should publish for public notice
and comment a full description of its behavior adjustment calculation,
including all the specific data used in the assessment along with the
complete calculation methodology. A commenter expressed concerns that
CMS is not considering the requirements of the Regulatory Flexibility
Act or the Small Business Regulatory Enforcement Fairness Act, which
limits the impact on small businesses. This commenter stated that many
home health agencies are considered ``small business'' and should be
afforded targeted oversight efforts rather than apply all claims to the
behavioral assumption analysis. The commenter recommended that CMS
consider alternatives to the behavioral adjustment that would take into
account any oversight to prevent up coding or unnecessary utilization
increased to offset the behavioral adjustment.
Response: We believe that it would be difficult to accurately
predict total aggregate budget neutral HH PPS expenditures for future
years because we cannot anticipate future year home health rate
updates, which vary from year to year. Furthermore, we cannot
anticipate any future legislative action that would require a set home
health rate update for any given year. As such, we do not believe that
providing this type of data would produce meaningful results for
providers' analytic purposes. However, with the proposed and this final
rule with comment period, we released the ``Home Health Claims--OASIS''
Limited Data Set (LDS) file, which contains information on the
utilization of the Medicare Home Health benefit on the CMS website.\20\
This LDS file is meant to support HHAs in evaluating the effects of the
PDGM and provides detailed information for HHAs. Therefore, we believe
that we have provided sufficient publically available information for
HHAs to utilize so they can fully understand the effects of the PDGM.
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\20\ Home Health Prospective Payment System (HH PPS) Limited
Data Set (LDS) web page. https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/Home_Health_PPS_LDS.html.
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We remind commenters that we did provide a detailed explanation as
to how we calculated the behavior adjustment in the CY 2020 proposed
rule (84 FR 34615). For this final rule with comment period, we used a
2018 analytic file that included 6,388,974 60-day episodes ($18 billion
in total expenditures); however 9.5 percent of claims were excluded
because they could not be linked to an OASIS assessment, or were RAPs
without a final claim, or they were claims with zero payment amounts.
After these and other exclusions, the resulting 2018 analytic file
represented 5,471,454 60-day episodes and $16.6 billion in total
expenditures. We do not agree that these excluded claims would be
useful for inclusion of the behavior assumption adjustment, nor do we
see any relationship between standard data cleaning procedures and the
Jimmo v. Sebelius settlement, which addresses Medicare coverage of
certain types of maintenance therapy for certain Medicare providers,
and does not reflect any behavioral analyses. Furthermore, we believe
the PDGM captures patient characteristics more closely associated with
complex care needs of the chronically ill as we have demonstrated in
our analysis of the PDGM (and previously, the HHGM). We also disagree
that this rule does not consider the requirements of the Regulatory
Flexibility Act or the Small Business Regulatory Enforcement Fairness
Act, which limits the impact on small
[[Page 60517]]
businesses. In fact, we are required to consider the impact of these
policies as we do in the Regulatory Impact Analysis section of the
proposed and final rules. Additionally, we refer commenters to Table 36
in the CY 2020 proposed rule that shows the CY 2020 estimated HHA
impacts by facility type and area of the country. Even with the 8.01
percent adjustment based on assumed behavior changes, we note that
smaller providers would have an estimated impact of a +2.1 percent
increase in payments as a result of the PDGM and an estimated overall
impact of +3.6 percent as a result of the proposed payment policies in
CY 2020. Finally, as noted throughout this rule, CMS is required to
reconcile the difference between assumed and observed behavior changes;
that is, we are required to examine the data beginning in CY 2020
through CY 2026 to determine the impact of the differences between
assumed behavior changes and actual behavior changes on estimated
aggregate expenditures to determine whether any temporary adjustments
for retrospective behavior or any permanent adjustments on a
prospective basis are warranted to offset such increases or decreases.
Comment: A commenter recommended that CMS should factor the impact
of decreased Medicare payments due to home health agency closures as
part of the budget neutrality analysis. This commenter stated that
evidence exists to support that a change to a new payment system will
lead to agency closures and provided the example of the change from
cost reimbursement payment system to the Interim Payment System and
then to the Home Health Prospective Payment System, which resulted in a
30 percent reduction in the number of home health agencies. The
commenter stated that the CY 2020 PDGM Agency Level Impacts file posted
with the CY 2020 proposed rule is misleading because it gives an
estimated PDGM revenue that does not include the adjustment due to the
behavioral assumptions.
Response: We agree with commenters that there have been notable
changes in the provision of home health services since the 1980s.
MedPAC has provided a detailed description of the use and growth of the
home health benefit and has shown how the benefit has varied
substantially because of changes in coverage and payment policy in its
reports.\21\ We remind commenters that implementation of the inpatient
hospital PPS in 1983 led to increased use of home health services as
hospital lengths of stay decreased. As a result, the number of home
health agencies (HHAs), users, and services expanded rapidly in the
early 1990s. As the rates of use and the duration of home health
episodes increased, there was concern that the benefit was serving more
as a long-term care benefit.\22\ The trends of the early 1990s prompted
increased program integrity actions, refinements of coverage standards,
temporary spending caps through an interim payment system (IPS), and
the eventual replacement of the cost-based payment system with a
prospective payment system in 2000. We agree that the implementation of
the IPS resulted in a decrease in the number of HHAs. However, after
the HH PPS was implemented, home health service use and agency supply
rebounded at a rapid pace. Between 2001 and 2017, the number of home
health episodes rose from 3.9 million to 6.3 million.\23\ In 2017, the
number of HHAs was 11,844--higher than the level of supply during the
1990s. Almost all the new agencies since implementation of the PPS have
been for-profit providers. We also note that in the CY 2014 HH PPS
final rule (78 FR 72282), commenters expressed similar concerns that
HHAs would be forced to close in response to the rebasing adjustment to
the 60-day national, standardized episode payment amount, required by
section 3131(a) of the Patient Protection and Affordable Care Act
(PPACA). In the CY 2014 HH PPS final rule, we finalized a 2.8 percent
reduction to the national, standardized 60-day episode payment rate in
each year beginning in CY 2014 through CY 2017. However, MedPAC has
reported that even with these rebasing reductions, HHAs were able to
adapt and there was no evidence of large-scale HHA closures or issues
with access to care. In fact, MedPAC reported that changes in average
payment per full episode (defined as episodes of more than four visits)
underscored the limited impact of the PPACA rebasing policy that was
implemented in 2014. Average payment per episode increased in the first
three years of rebasing and the average payment per episode in 2016,
the third year of rebasing, was 3.1 percent higher than the average
payment per episode in 2013, before rebasing was implemented.\24\
Therefore, we do not believe there will be large-scale HHA closures or
issues with access to care as a result of the implementation of the
PDGM, given past experience of HHAs adapting to payment system changes.
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\21\ MedPAC report, ``Home Care Services'', March 2019. http://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch9_sec.pdf?sfvrsn=0.
\22\ Government Accountability Office. 1996. Medicare: Home
health utilization expands while program controls deteriorate. GAO/
HEHS-96-16. Washington, DC: GAO.
\23\ MedPAC report, ``Home Care Services'', March 2019. http://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch9_sec.pdf?sfvrsn=0.
\24\ MedPAC Report, Home Care Services'', chapter 9, March 2018.
http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch9_sec.pdf?sfvrsn=0.
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While we recognize that there can be a shift in provider practice
patterns in response to payment changes, we believe that the PDGM puts
patient characteristics and other pertinent clinical information at the
forefront in adjusting home health payments to account for increases in
resource use. We believe this is an improvement over other significant,
past case-mix adjustment and payment changes because of the primary
focus on patient characteristics that affect resource utilization.
However, we are also aware that the transition to a 30-day unit of
payment and implementation of a new case-mix system, the first
significant payment changes to the HH PPS in almost 20 years, warrants
modifications to HHA billing practices, software systems, and staff
education. As we have stated since we finalized the PDGM in the CY 2019
final rule with comment period, we will continue to monitor the
provision of home health services, including any changes in the
composition of the disciplines providing such services, overall home
health payments, and any effects on HHAs to determine if any unintended
consequences result from the change in the case-mix adjustment
methodology and the 30-day unit of payment that may warrant refinements
in future rulemaking.
Comment: Most commenters expressed concern about the impact of the
proposed 8.01 percent reduction in payment based on assumed behavior
changes that HHAs may make in response to the change in the case-mix
adjustment methodology and the change to a 30-day unit of payment.
Commenters stated that this reduction would be one of the most
significant reductions taken in any new or existing Medicare payment
systems to date and would result in negative financial consequences,
especially for smaller, rural HHAs that may not be able to make the
changes necessary to adapt to the PDGM immediately upon implementation.
Response: We note that the overall impact on the estimated
aggregate expenditures resulting from the PDGM and the 30-day unit of
payment is zero
[[Page 60518]]
given the statutory requirement that these changes are implemented in a
budget-neutral manner. We appreciate commenter concerns regarding the
impact of these assumptions on smaller and rural HHAs. We refer to
Table 36 in the CY 2020 HH PPS proposed rule (84 FR 34706), which shows
that the impact of the PDGM and the 30-day unit of payment (with
behavior assumptions) on rural providers would be 3.7 percent and the
impact on smaller providers (less than 100 episodes) would be 2.1
percent. Therefore, we believe that rural and smaller HHAs would
recognize an increase in overall payments under the PDGM and the 30-day
unit of payment.
We also remind commenters that even with the behavior assumption
adjustment of 8.389 percent, the CY 2020 30-day payment rate of
$1,785.51 (including the wage index standardization factor and the CY
2020 rate update) would be approximately 11 percent higher than the
estimated, CY 2020 30-day period cost of $1,608.82. Additionally, in
its comments on the proposed rule, MedPAC states that the analysis of
payments and costs in the proposed rule suggests that payments will be
more than adequate in 2020. However, we will continue to monitor the
effect of the payment changes, including the impacts on smaller and
rural providers to mitigate any potential unintended consequences.
Moreover, we are required to examine the data beginning in CY 2020
through CY 2026 to determine the impact of the differences between
assumed behavior changes and actual behavior changes on estimated
aggregate expenditures to determine whether any temporary adjustments
for retrospective behavior or any permanent adjustments on a
prospective basis are warranted to offset such increases or decreases.
Comment: Many commenters stated that the magnitude of the 8.01
percent reduction to the home health 30-day payment rate has the
potential to create negative consequences for providers transitioning
to a new case-mix adjustment methodology and a change in the unit of
payment. Several commenters mentioned the provider burden associated
with other existing and new requirements, including HHVBP and the
resumption of the Review Choice Demonstration and stated that there are
too many changes occurring simultaneously and that many HHAs,
especially smaller and rural providers, could not incur the costs of
all of these changes all at once. Several commenters stated they
recognize the statutory requirement to make such behavior assumptions
when calculating the budget-neutral 30-day payment rate, but requested
that CMS phase-in the behavior assumption reduction over a period of
three years, rather than all at one time. Several commenters recognize
the phase-out of the rural add-on is based on the Bipartisan Budget Act
of 2018 with no latitude to revise the proposal, however, they suggest
CMS takes this into consideration in relation to the 8.01 behavioral
adjustment. Some commenters indicate the phase-out of the rural add-on
payment, coupled with other payment system changes, would be difficult
for rural HHAs to fiscally manage. Other commenters stated the
assumption that 100 percent of providers will change coding practices
and make such changes 100 percent of the time, without sufficient data,
is an overestimation and suggested that reduction percentage be halved,
as this is a more realistic assumption about the frequency of such
behavior changes.
Response: We appreciate commenter concerns about the potential
impact of the behavior assumption adjustment. We recognize that
transitioning to the first significant HH PPS payment system change in
almost 20 years requires a considerable amount of system changes, staff
education, and modification of current billing processes. We are also
cognizant that there have been recent changes to the home health CoPs,
as well as a resumption of the Review Choice Demonstration, and
continuation of the HHVBP for some select states. We also understand
concerns by rural HHAs as to the impact of the phase-out of the rural
add-on payment coupled with other changes that may challenge their
fiscal management.
We continue to believe that the behavior assumptions are valid ones
and supported by evidence as described in the CY 2019 final rule with
comment period and the CY 2020 proposed rule. However, given the scale
of the payment system changes, we agree that it might take HHAs more
time before they fully implement the behavior assumed by CMS. As we
noted in response to comments in the CY 2019 HH PPS final rule with
comment (83 FR 56456), in the FY 2008 IPPS final rule, CMS estimated
that a total adjustment of 4.8 percent would be necessary to maintain
budget neutrality for the transition to the MS-DRGs (72 FR 47178).
However, examining subsequent analysis of claims data for FYs 2008 and
2009, our actuaries determined that the implementation of the MS-DRG
system resulted in a 2.5 percent change in documentation and coding
(about half of the estimated 4.8 percent change expected) in the first
year of the MS-DRGs and a 5.4 percent change in documentation and
coding in the second year of the MS-DRGs. Taking into consideration the
example above and the transition to the new PDGM payment system in
combination with other ongoing or new home health requirements, we
believe it is reasonable to apply the three previously outlined
behavior change assumptions to only half of the 30-day periods in our
analytic file (randomly selected). Note that since payment is made for
30-day periods, it is more accurate to apply the behavior assumptions
to half the 30-day periods than to assume the magnitude of the
behaviors would be halved. Therefore, taking this approach means that
the resulting adjustment to the 30-day payment amount needed to
maintain budget neutrality, as required by law, is an adjustment of -
4.36 percent. This means that the CY 2020 30-day budget-neutral payment
amount will be $1,824.99 (not including the wage index standardization
factor and the 1.5 percent home health rate update for CY 2020).
We remind commenters that after implementation of the 30-day unit
of payment and the PDGM, CMS is required by law to annually analyze
data from CYs 2020-2026 to determine the impact of the difference
between assumed behavior changes and actual behavior changes to
determine if any temporary or permanent payment adjustments to the 30-
day payment amount are needed to offset for such increases or decreases
in estimated aggregate expenditures. Therefore, if CMS underestimates
the amount of the reductions to the 30-day payment rate necessary to
offset behavior changes and maintain budget neutrality for CY 2020,
larger adjustments to the 30-day payment amount would be required in
the future, pursuant to section 1895(b)(3)(D) of the Act, to ensure
budget neutrality with respect to estimated expenditures for CY 2020.
Likewise, if CMS overestimates the reductions, we are required to make
the appropriate payment adjustments accordingly, as described
previously. The law also requires that any permanent or temporary
payment adjustment would be proposed through rulemaking. We will review
data from CY 2020 to inform next year's rulemaking to determine if any
change to the behavior assumption adjustment percentage should be
proposed in CY 2021 (for example, if the full 8.389 percent reduction
should be proposed in CY 2021 based on actual, observed data from CY
2020). While we are applying all three assumptions for establishing a
30-day payment rate, we are changing our assumption regarding
[[Page 60519]]
the frequency with which those behaviors would occur in the first year
of implementation.
Final Decision: Based on the comments received and reconsideration
as to frequency of the assumed behaviors during the first year of the
transition to a new unit of payment and case-mix adjustment
methodology, we are finalizing a -4.36 percent behavior change
assumptions adjustment in order to calculate the 30-day payment rate in
a budget-neutral manner for CY 2020. This adjustment will be made using
the three behavior assumptions finalized in the CY 2019 HH PPS final
rule with comment period (83 FR 56461).
The finalized 30-day budget-neutral payment amount with the -4.36
percent behavioral assumption adjustment will be $1,824.99 and the CY
2020 30-day payment rate, with the wage-index budget neutrality factor
and the home health payment update of 1.5 percent, will be $1,864.03
with a fixed-dollar loss ratio of 0.56. Section III.E. of this final
rule with comment period describes the CY 2020 home health payment rate
update and section III.F. describes the payments for high-cost outliers
and the fixed-dollar loss ratio for the CY 2020 HH PPS.
Finally, we also wish to remind stakeholders again that CMS will
provide, upon request, a Home Health Claims-OASIS LDS file to accompany
the CY 2020 final rule with comment period to support HHAs in
evaluating the effects of the PDGM. The Home Health Claims-OASIS LDS
file can be requested by following the instructions on the CMS Limited
Data Set (LDS) Files website. Additionally, we have posted the CY 2020
provider-level impacts and an updated Interactive Grouper Tool on the
HHA Center web page and the PDGM web page to provide HHAs with ample
tools to help them understand the impact of the PDGM and the change to
a 30-day unit of payment.\25\
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\25\ Home Health Agency (HHA) Center web page. https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html.
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C. CY 2020 HH PPS Case-Mix Weights for 60-Day Episodes of Care That
Span the Implementation Date of the PDGM
In the CY 2015 HH PPS final rule (79 FR 66072), we finalized a
policy to annually recalibrate the HH PPS case-mix weights--adjusting
the weights relative to one another--using the most current, complete
data available. Annual recalibration of the HH PPS case-mix weights
ensures that the case-mix weights reflect, as accurately as possible,
current home health resource use and changes in utilization patterns.
The CY 2020 HH PPS proposed rule (84 FR 34617), outlined the
implementation of the PDGM and a change in the unit of home health
payment to 30-day periods of care. As such, we are recalibrating the CY
2020 case-mix weights for 30-day periods of care using the PDGM
methodology. However, these recalibrated case-mix weights are not
applicable for those 60-day episodes of care that begin on or before
December 31, 2019 and end on or after January 1, 2020. We did not
propose to separately recalibrate the case-mix weights for those 60-day
episodes that span the January 1, 2020 implementation date, rather we
proposed, that these 60-day episodes would be paid the national,
standardized 60-day episode payment amount and would be case-mix
adjusted using the CY 2019 case-mix weights as listed in Table 6 in the
CY 2019 HH PPS final rule with comment period (83 FR 56422) and posted
on the HHA Center web page. With the implementation of a new case-mix
adjustment methodology and a move to a 30-day unit of payment, we
believe this approach will be less burdensome for HHAs as they will not
have to download a new, separate 153-group case-mix weight data file,
in addition to the 432 case-mix weight data file for CY 2020. For those
60-day episodes that end after January 1, 2020, but where there is a
continued need for home health services, we are proposed that any
subsequent periods of care would be paid the 30-day national,
standardized payment amount with the appropriate CY 2020 PDGM case-mix
weight applied.
We solicited comments on the proposed payment for 60-day episodes
of care that span the January 1, 2020 implementation date of the PDGM
and the change to a 30-day unit of payment. We received a comment from
an industry association and this comment and our response is summarized
in this section of this final rule with comment period.
Comment: A commenter did not agree with our proposal to not
recalculate the of case-mix weights for 60-day episodes that span
implementation of the PDGM and the change to a 30-day unit of payment
given that the national, standardized 60-day episode payment rate is
being updated for CY 2020. This commenter stated that all variables
that affect payment in CY 2020 should be updated for 2020.
Response: We note that we are recalibrating the case-mix weights
for 30-day periods of care beginning in CY 2020 in accordance with our
policy to annually recalibrate the HH PPS case-mix weights. We note
that any recalibration to the case-mix weights for those 60-day
episodes that span the January 1, 2020 implementation date of the new
case-mix system and the change to a 30-day unit of payment would be
very similar to the CY 2019 case-mix weights. We remind commenters that
we did propose to update the national, standardized 60-day episode
payment amount for CY 2020, which does result in an increased base rate
for these episodes of care. We continue to believe that this approach
to the case-mix weights for those 60-day episodes that span into CY
2020 is less burdensome for HHAs who are transitioning to a new case-
mix methodology and a 30-day unit of payment.
Final Decision: We are finalizing as proposed that 60-day episodes
spanning the January 1, 2020 implementation date of the PDGM and the
change to a 30-day unit of payment will be paid the CY 2020 national,
standardized 60-day episode payment amount of $3,220.79 (see Table 17),
and will be case-mix adjusted using the CY 2019 case-mix weights as
listed in the CY 2019 HH PPS final rule with comment period (83 FR
56422) and posted on the HHA Center web page.\26\ Additionally, for
those 60-day episodes that end after January 1, 2020, but where there
is a continued need for home health services, any subsequent periods of
care will be paid the CY 2020 national, standardized 30-day period
payment amount (as shown in section III.E of this final rule with
comment period) with the appropriate CY 2020 PDGM case-mix weight
applied.
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\26\ Home Health Agency web page. https://www.cms.gov/center/
provider-Type/home-Health-Agency-HHA-Center.html.
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D. CY 2020 PDGM Low-Utilization Payment Adjustment (LUPA) Thresholds
and PDGM Case-Mix Weights
1. CY 2020 PDGM LUPA Thresholds
Under the current 153-group payment system, a 60-day episode with
four or fewer visits is paid the national per-visit amount by
discipline adjusted by the appropriate wage index based on the site of
service of the beneficiary, instead of the full 60-day episode payment
amount. Such payment adjustments are called Low-Utilization Payment
Adjustments (LUPAs). In the current payment system, approximately 7 to
8 percent of episodes are LUPAs.
LUPAs will still be paid upon implementation of the PDGM. However,
the approach to calculating the LUPA thresholds has changed due to the
change in the unit of payment to 30-day
[[Page 60520]]
periods of care from 60-day episodes. As detailed in the CY 2019 HH PPS
proposed rule (83 FR 32411), there are substantially more home health
periods of care with four or fewer visits in a 30-day period than in
60-day episodes; therefore, we believe that the LUPA thresholds for 30-
day periods of care should be correspondingly adjusted to target
approximately the same percentage of LUPA episodes as under the current
HH PPS case-mix system, which is approximately 7 to 8 percent of all
episodes. To target approximately the same percentage of LUPAs under
the PDGM, LUPA thresholds are set at the 10th percentile value 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. In the CY
2019 HH PPS final rule with comment period (83 FR 56492), we finalized
that the LUPA thresholds for each PDGM payment group will be
reevaluated every year based on the most current utilization data
available at the time of rulemaking. Therefore, we used CY 2018
Medicare home health claims (as of July 31, 2019) linked to OASIS
assessment data for this rule. The LUPA thresholds for the CY 2020 PDGM
payment groups with the corresponding Health Insurance Prospective
Payment System (HIPPS) codes and the case-mix weights are listed in
Table 16. Under the PDGM, if the LUPA threshold is met, the 30-day
period of care will be paid the full 30-day period payment. If a 30-day
period of care does not meet the PDGM LUPA visit threshold, as detailed
previously, then payment will be made using the CY 2020 per-visit
payment amounts. 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.
2. CY 2020 PDGM Case-Mix Weights
Section 1895(b)(4)(B) of the Act requires the Secretary to
establish appropriate case mix adjustment factors for home health
services in a manner that explains a significant amount of the
variation in cost among different units of services. 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 characteristics (principal diagnosis, functional level,
comorbid conditions, admission source and timing). The PDGM case-mix
methodology results in 432 unique case-mix groups called Home Health
Resource Groups (HHRGs).
To generate the CY 2020 PDGM case-mix weights, we utilized a data
file based on home health 30-day periods of care, as reported in CY
2018 Medicare home health claims (as of July 31, 2019) linked to OASIS
assessment data to obtain patient characteristics. These data are the
most current and complete data available at this time. The claims data
provides visit-level data and data on whether NRS was provided during
the period and the total charges of NRS. We determine the case-mix
weight for each of the 432 different PDGM payment groups by regressing
resource use on a series of indicator variables for each of the
categories using a fixed effects model as described in the steps
detailed in this section of this final rule with comment period:
Step 1: Estimate a regression model to assign a functional
impairment level to each 30-day period. The regression model estimates
the relationship between a 30-day period's resource use and the
functional status and risk of hospitalization items included in the
PDGM which are obtained from certain OASIS items. We measure resource
use with the cost-per-minute + NRS approach that uses information from
home health cost reports. Other variables in the regression model
include the 30-day period's admission source; clinical group; and 30-
day period timing. We also include home health agency level fixed
effects in the regression model. After estimating the regression model
using 30-day periods, we divide the coefficients that correspond to the
functional status and risk of hospitalization items by 10 and round to
the nearest whole number. Those rounded numbers are used to compute a
functional score for each 30-day period by summing together the rounded
numbers for the functional status and risk of hospitalization items
that are applicable to each 30-day period. Next, each 30-day period is
assigned to a functional impairment level (low, medium, or high)
depending on the 30-day period's total functional score. Each clinical
group has a separate set of functional thresholds used to assign 30-day
periods into a low, medium or high functional impairment level. We set
those thresholds so that we assign roughly a third of 30-day periods
within each clinical group to each functional impairment level (low,
medium, or high).
Step 2: Next, a second regression model estimates the relationship
between a 30-day period's resource use and indicator variables for the
presence of any of the comorbidities and comorbidity interactions that
were originally examined for inclusion in the PDGM. Like the first
regression model, this model also includes home health agency level
fixed effects and includes control variables for each 30-day period's
admission source, clinical group, timing, and functional impairment
level. After we estimate the model, we assign comorbidities to the low
comorbidity adjustment if any comorbidities have a coefficient that is
statistically significant (p-value of .05 or less) and which have a
coefficient that is larger than the 50th percentile of positive and
statistically significant comorbidity coefficients. If two
comorbidities in the model and their interaction term have coefficients
that sum together to exceed $150 and the interaction term is
statistically significant (p-value of .05 or less), we assign the two
comorbidities together to the high comorbidity adjustment.
Step 3: After Step 2, each 30-day period is assigned to a clinical
group, admission source category, episode timing category, functional
impairment level, and comorbidity adjustment category. For each
combination of those variables (which represent the 432 different
payment groups that comprise the PDGM), we then calculate the 10th
percentile of visits across all 30-day periods within a particular
payment group. If a 30-day period's number of visits is less than the
10th percentile for their payment group, the 30-day period is
classified as a Low Utilization Payment Adjustment (LUPA). If a payment
group has a 10th percentile of visits that is less than two, we set the
LUPA threshold for that payment group to be equal to two. That means if
a 30-day period has one visit, it is classified as a LUPA and if it has
two or more visits, it is not classified as a LUPA.
Step 4: Finally, we take all non-LUPA 30-day periods and regress
resource use on the 30-day period's clinical group, admission source
category, episode timing category, functional impairment level, and
comorbidity adjustment category. The regression includes fixed effects
at the level of the home health agency. After we estimate the model,
the model coefficients are used to predict each 30-day period's
resource use. To create the case-mix weight for each 30-day period, the
predicted resource use is divided by the overall resource use of the
30-day periods used to estimate the regression.
The case-mix weight is then used to adjust the base payment rate to
determine each 30-day period's payment. Table 15 shows the coefficients
of the payment regression used to generate the weights, and the
[[Page 60521]]
coefficients divided by average resource use.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR08NO19.021
BILLING CODE 4120-01-C
[[Page 60522]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.022
Table 16 presents the HIPPS code, the LUPA threshold, and the case-
mix weight for each Home Health Resource Group (HHRG) in the regression
model for CY 2020.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR08NO19.023
[[Page 60523]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.024
[[Page 60524]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.025
[[Page 60525]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.026
[[Page 60526]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.027
[[Page 60527]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.028
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[GRAPHIC] [TIFF OMITTED] TR08NO19.029
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[GRAPHIC] [TIFF OMITTED] TR08NO19.030
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[GRAPHIC] [TIFF OMITTED] TR08NO19.031
[[Page 60531]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.032
[[Page 60532]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.033
[[Page 60533]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.034
BILLING CODE 4120-01-C
The following is a summary of the comments received and our
responses to comments on the CY 2020 PDGM LUPA Thresholds and PDGM
Case-Mix Weights.
Comment: A few commenters stated that the case mix weights for
clinical groups that include therapy services are significantly
depressed from the weights that would be assigned if CMS continued to
use BLS data. These commenters expressed concern that there is a
reduction in payment rates for therapy clinical groups and this would
create barriers to care for patients needing therapy. These commenters
urged CMS to continue to use BLS data for determining the PDGM case-mix
weights.
Response: We finalized the CPM+NRS approach to calculating the
costs of care in the CY 2019 HH PPS final rule with comment period and
in that rule we stated that we believe that the use of HHA Medicare
cost reports better reflects changes in utilization, provider payments,
and supply amongst Medicare-certified HHAs that occur over time. Under
a Wage-Weighted Minutes of Care (WWMC) approach, using the BLS average
hourly wage rates for the entire home health care service industry does
not reflect changes in Medicare home health utilization that impact
costs, such as the allocation of overhead costs when Medicare home
health visit patterns change. Using data from HHA Medicare cost reports
better represents the total costs incurred during a 30-day period
(including, but not limited to, direct patient care contract labor,
overhead, and transportation costs), while the WWMC method provides an
estimate of only the labor costs (wage and fringe benefit costs)
related to direct patient care from patient visits that are incurred
during a 30-day period. We will recalibrate the case-mix weights
annually, as is currently done, to ensure that the case-mix weights
accurately align with the cost of providing care.
Comment: A commenter recognized the long-term improvement of the
LUPA proposal to align low acuity episodes with a lower LUPA threshold
while high-acuity episodes would have higher LUPA threshold. A few
commenters stated that the LUPA thresholds are confusing and
recommended a more straightforward approach to pay for LUPAs. Another
commenter remarked that there were some institutional admission source
LUPA thresholds that had less number of visits to meet the threshold
than their community admission source counterparts and questioned if
this was accurate. This commenter also stated that other institutional
admission source thresholds were only one visit more than their
community admission source counterpart and that this seems incorrect if
institutional admission sources have higher resource costs than
community admission sources.
Response: Because of the change in the unit of payment from a 60-
day episode to a 30-day period, the approach to calculating the LUPA
thresholds needed to change in order to target approximately the same
percentage of LUPAs. As we discussed in both the CYs 2018 and 2019 HH
PPS proposed rules, 30-day periods of care have substantially more
episodes with four or fewer visits than 60-day episodes. To create LUPA
thresholds for 30-day periods of care, we finalized in the CY 2019
final rule with comment period to set the LUPA threshold at the 10th
percentile value of visits or 2, whichever is higher, for each payment
group, in order to target approximately the same percentage of LUPAs
(approximately 7.1 percent of 30-day periods would be LUPAs (assuming
no behavior change)) (83 FR 56492). We note that under the current HH
PPS, LUPA episodes are billed the same as a non-LUPA episodes and this
will not change under the PDGM where LUPA periods of care will be
billed the same way as non-LUPA 30-day periods of care; therefore, we
do not believe that this would cause any confusion related to billing.
The commenter is correct that there are some institutional
admission source LUPA thresholds that are less than their community
counterparts. The LUPA threshold does not necessarily relate to the
case-mix weight of the 30-day period. For example, looking at the case-
mix group, Behavioral Health--Low Functional Impairment, Early Timing,
Low Comorbidity Adjustment:
Community 30-day periods have an average resource use of
$1,655.70 and a LUPA threshold of 4 visits.
Institutional 30-day periods have average resource use of
$1,804.17 and a LUPA threshold of 3 visits.
We remind commenters that we finalized the policy for the PDGM LUPA
thresholds to target approximately the same percentage of LUPAs as
under the 153 case-mix weight system using the criteria noted
previously. We continue to believe that the LUPA thresholds that vary
based on the case-mix assignment for the 30-day period of care in the
proposed PDGM is an improvement over the current 5 visit threshold that
does not vary by case-mix assignment. Likewise, in the CY 2019 HH PPS
final rule with comment period (83 FR 56492), we finalized that the
LUPA thresholds for each PDGM payment group will be reevaluated every
year based on the most current utilization data available.
[[Page 60534]]
Final Decision: We are maintaining our finalized policy in the CY
2019 HH PPS final rule with comment period (83 FR 56492) to vary the
LUPA thresholds for each 30-day period of care depending on the PDGM
payment group to which it is assigned. Additionally, we are finalizing
the CY 2020 LUPA thresholds and case-mix weights as shown in Table 16
in this final rule with comment period. We will continue to update the
LUPA thresholds by payment group and will annually recalibrate the
case-mix weights using the most current data available at the time of
rulemaking.
E. CY 2020 Home Health Payment Rate Updates
1. CY 2020 Home Health Market Basket Update for HHAs
Section 1895(b)(3)(B) of the Act requires that the standard
prospective payment amounts for CY 2020 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 except in 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 see http://www.bls.gov/mfp, to
obtain the BLS historical published MFP data.
The home health update percentage for CY 2020 would have been based
on the estimated home health market basket update, specified at section
1895(b)(3)(B)(iii) of the Act, of 2.9 percent (based on IHS Global
Insight Inc.'s third-quarter 2019 forecast). However, due to the
requirements specified at section 1895(b)(3)(B)(vi) of the Act prior to
the enactment of the BBA of 2018, the estimated CY 2020 home health
market basket update of 2.9 percent would have been 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) and
currently estimated to be 0.3 percentage point for CY 2020. In effect,
the home health payment update percentage for CY 2020 would have been a
2.6 percent increase. However, section 53110 of the BBA of 2018 amended
section 1895(b)(3)(B) of the Act, such that for home health payments
for CY 2020, the home health payment update is required to be 1.5
percent. The MFP adjustment is not applied to the BBA of 2018 mandated
1.5 percent payment update. 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 2020, the home health payment update will be -0.5 percent (1.5
percent minus 2 percentage points).
2. CY 2020 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 proposed to
continue this practice for CY 2020, 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. Specifically, we proposed to use the FY 2020
pre-floor, pre-reclassified hospital wage index as the CY 2020 wage
adjustment to the labor portion of the HH PPS rates. For CY 2020, the
updated wage data are for hospital cost reporting periods beginning on
or after October 1, 2015, and before October 1, 2016 (FY 2016 cost
report data). We 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 2020 HH PPS wage index, we proposed 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 proposed 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 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 proposed to continue to use the most recent wage index
previously available for that area. 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
2020, the only urban area without inpatient hospital wage data is
Hinesville, GA (CBSA 25980). The CY 2020 wage index value for
Hinesville, GA is 0.8322.
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
the OMB's new 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
[[Page 60535]]
the principal city of Twin Falls, Idaho in Jerome County, Idaho and
Twin Falls County, Idaho. The CY 2020 HH PPS wage index value for CBSA
46300, Twin Falls, Idaho, will be 0.8291. The August 15, 2017 Bulletin
No. 17-01, Revised Delineations of Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas, and
Guidance on Uses of the Delineations of These Areas, is available at
https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
The most recent OMB Bulletin (No. 18-04) was published on September
14, 2018 and is available at https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.
The revisions contained in OMB Bulletin No. 18-04 have no impact on
the geographic area delineations that are used to wage adjust HH PPS
payments.
The CY 2020 wage index is available on the CMS Home Health
Prospective Payment System Regulations and Notices web page: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html.
We received 1 comment regarding the CY 2020 Home Health wage index.
The comment and our response appear in this section of this final rule
with comment period:
Comment: A commenter questioned the validity of the CY 2020 wage
index data in the case of the CBSA for Albany-Schenectady-Troy, noting
that in the past 6 years, this CBSA has seen its wage index reduced
5.17 percent, going from 0.8647 in 2013 to a proposed CY 2020 wage
index of 0.820. This commenter also suggests that the Albany-
Schenectady-Troy CBSA should not be lower than any of the following
other upstate New York CBSAs: Binghamton, Elmira, Glen Falls,
Rochester, Syracuse, Watertown-Fort Drum and, most significantly, the
``New York Rural Areas CBSA,'' which is proposed to be 0.8431.
Response: As discussed in the CY 2017 HH PPS final rule (81 FR
76721), we believe that the wage index values are reflective of the
labor costs in each geographic area as they reflect the costs included
on the cost reports of hospitals in those specific labor market areas.
The area wage index measures differences in hospital wage rates among
labor market areas and compares the area wage index of the labor market
area to the national average hourly wage. If a hospital or labor market
area does not keep pace with the national average hourly wage in a
given year, then the labor market area will see a decrease in the area
wage index during that year.
We utilize efficient means to ensure and review the accuracy of the
hospital cost report data and resulting wage index. Hospitals must
complete the wage index survey (Worksheet S-3, Parts II and III) as
part of their Medicare cost reports. Cost reports will be rejected if
Worksheet S-3 is not completed. Medicare contractors perform desk
reviews on all hospitals' Worksheet S- 3 wage data, and we run edits on
the wage data to further ensure the accuracy and validity of the wage
data. If any provider believes the underlying hospital wage data is
inaccurate, the data would have to be corrected by the Medicare
Administrative Contractor (MAC) within the necessary timeframe in order
for the error to be corrected; otherwise the data would be deemed final
for that upcoming year's wage index. The time table used for the
development of the FY 2020 hospital wage index can be found at the
following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Downloads/FY2020-Hospital-Wage-Index-Development-Time-Table.pdf. We believe that our review processes result
in an accurate reflection of the applicable wages for the areas given.
3. Comment Solicitation
Historically, we have calculated the home health wage index values
using unadjusted wage index values from another provider setting.
Stakeholders have frequently commented on certain aspects of the home
health wage index values and their impact on payments. We solicited
comments on concerns stakeholders may have regarding the wage index
used to adjust home health payments and suggestions for possible
updates and improvements to the geographic adjustment of home health
payments.
The following is a summary of the comments received on the proposed
CY 2020 home health wage index comment solicitation, and our responses:
Comment: A few commenters recommended that the wage index account
for areas with higher minimum wage standards. A commenter stated that
the pre-floor, pre-reclassified hospital wage index is ``wholly
inadequate for adjusting home health costs, particularly in states like
New York which has among the nation's highest labor costs now greatly
exacerbated by the states implementation of a phased in $15 per hour
minimum wage hike, the balance of which is unfunded by Medicare.''
Another commenter suggested that CMS develop a reimbursement system
adjustment providing supplemental funding to providers, such as HHAs,
required to meet higher minimum wage standards, better to align
reimbursement rates with cost trends impacting these providers.
Response: Regarding minimum wage standards, we note that such
increases would be reflected in future data used to create the hospital
wage index to the extent that these changes to state minimum wage
standards are reflected in increased wages to hospital staff.
Comment: Several commenters recommended that CMS consider
consulting with home health agencies to develop a home health specific
wage index or explore opportunities to improve the wage index applied
to home health. A commenter urges CMS to consider a home health
specific wage index to support staff retention due to increased demands
on meeting paperwork and regulatory requirements. The commenter notes
that the current home health wage index is tied to hospital wage data,
which does not reflect the true cost of hiring and retaining high
quality home health staff. Another commenter suggested that CMS use
home health specific data contained in home health cost reports, which
contain average cost per visit. A commenter recommended that CMS use
the post-reclassified wage index values for each CBSA. Another
commenter indicated that ``CMS should include wage data from
reclassified hospitals in calculating the rural wage index for home
health agencies.'' The same commenter indicated that CMS should examine
how population density impacts home health agency costs and then adjust
the wage index by multiplying by a population density factor so that
areas with a lower population density have a higher adjusted wage
index. A few commenters indicated that an approach similar to that used
in the FY 2020 Inpatient Hospital PPS final rule should be used, where
hospitals with a wage index value that was less than the 25th
percentile had their wage index increased. A commenter also suggested
that a wage index floor should be established similar to the 0.8
hospice wage index floor.
Response: We thank the commenters for their comments. We will
consider these recommendations for future rulemaking.
Final Decision: After considering the comments received in response
to the CY 2020 HH PPS proposed rule, we are finalizing our proposal to
continue to use the pre-floor, pre-reclassified
[[Page 60536]]
hospital inpatient wage index as the wage adjustment to the labor
portion of the HH PPS rates. For CY 2020, the updated wage data are for
the hospital cost reporting periods beginning on or after October 1,
2015 and before October 1, 2016 (FY 2016 cost report data). The final
CY 2020 wage index is available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html.
4. CY 2020 Annual Payment Update
a. 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 section III.B of
this rule, the unit of home health payment will change from a 60-day
episode to a 30-day period effective for those 30-day periods beginning
on or after January 1, 2020. However, the standardized 60-day payment
rate will apply to case-mix adjusted episodes (that is, not LUPAs)
beginning on or before December 31, 2019 and ending on or after January
1, 2020. As such, the latest date such a 60-day crossover episode could
end on is February 28, 2020. Those 60-day crossover episodes that begin
on or before December 31, 2019, but are LUPA episodes, will be paid the
national, per-visit payment rates as shown in Table 17.
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 to rebase and revise 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 60-day episode (for those
episodes that span the implementation date of January 1, 2020) and 30-
day period rates for CY 2020:
Multiply the national, standardized 60-day episode rate or
30-day period rate by the 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 60-day episode rate or 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 60-day episode rate or 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.
Medicare pays both the national, standardized 60-day and 30-day
case-mix and wage-adjusted payment amounts on a split percentage
payment approach for those HHAs eligible for such payments. The split
percentage payment approach includes an initial percentage payment and
a final percentage payment as set forth in Sec. 484.205(b)(1) and (2).
The claim that the HHA submits for the final percentage payment
determines the total payment amount for the episode or period and
whether we make an applicable adjustment to the 60-day or 30-day case-
mix and wage-adjusted payment amount. We refer stakeholders to section
III.G. of this rule regarding proposals on changes to the current split
percentage policy in CY 2020 and subsequent years. The end date of the
60-day episode or 30-day period, as reported on the claim, determines
which calendar year rates Medicare will use to pay the claim.
We may also adjust the 60-day or 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) as set forth
in Sec. Sec. 484.205(d)(1) and 484.230.
A partial episode payment (PEP) 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.
b. CY 2020 National, Standardized 60-Day Episode Payment Rate
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 2020 national, standardized
60-day episode payment rate for those 60-day episodes that span the
implementation date of the PDGM and the change to a 30-day unit of
payment, we apply a wage index budget neutrality factor and the home
health payment update percentage discussed in section III.E. of this
rule. We did not propose to update the case-mix weights for the 153-
group case-mix methodology in CY 2020 as outlined in section III.D. of
this rule. Because we will use the CY 2019 case-mix weights, we do not
apply a case-mix weight budget neutrality factor to the CY 2020 60-day
episode payment rate.
To calculate the wage index budget neutrality factor, we simulated
total payments for non-LUPA episodes using the final CY 2020 wage index
and compared it to our simulation of total payments for non-LUPA
episodes using the CY 2019 wage index. By dividing the total payments
for non-LUPA episodes using the CY 2020 wage index by the total
payments for non-LUPA episodes using the CY 2019 wage index, we obtain
a wage index budget neutrality factor of 1.0060. We apply the wage
index budget neutrality factor of 1.0060 to the calculation of the CY
2020 national, standardized 60-day episode payment rate.
Next, we update the 60-day payment rate by the CY 2020 home health
payment update percentage of 1.5 percent as required by section 53110
of the BBA of 2018 and as described in section III.E.1. of this rule.
The CY 2020 national, standardized 60-day episode payment rate is
calculated in Table 17.
[[Page 60537]]
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The CY 2020 national, standardized 60-day episode payment rate for
an HHA that does not submit the required quality data is updated by the
CY 2020 home health payment update of 1.5 percent minus 2 percentage
points and is shown in Table 18.
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c. CY 2020 Non-Routine Medical Supply (NRS) Payment Rates for CY 2020
60-Day Episodes of Care
All medical supplies (routine and non-routine) must be provided by
the HHA while the patient is under a home health plan of care. Examples
of supplies that can be considered non-routine include dressings for
wound care, IV supplies, ostomy supplies, catheters, and catheter
supplies. Payments for NRS are computed by multiplying the relative
weight for a particular severity level by the NRS conversion factor. To
determine the CY 2020 NRS conversion factor, we updated the CY 2019 NRS
conversion factor ($54.20) by the CY 2020 home health payment update
percentage of 1.5 percent. We did not apply a standardization factor as
the NRS payment amount calculated from the conversion factor is not
wage or case-mix adjusted when the final claim payment amount is
computed. The NRS conversion factor for CY 2020 is shown in Table 19.
[GRAPHIC] [TIFF OMITTED] TR08NO19.037
Using the CY 2020 NRS conversion factor, the payment amounts for
the six severity levels are shown in Table 20.
[[Page 60538]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.038
For HHAs that do not submit the required quality data, we updated
the CY 2019 NRS conversion factor ($54.20) by the CY 2020 home health
payment update percentage of 1.5 percent minus 2 percentage points. To
determine the CY 2020 NRS conversion factor for HHAs that do not submit
the required quality data we multiplied the CY 2019 NRS conversion
factor ($54.20) by the CY 2020 HH Payment Update (0.995) to determine
the CY 2020 NRS conversion factor ($53.93). The CY 2020 NRS conversion
factor for HHAs that do not submit quality data is shown in Table 21.
[GRAPHIC] [TIFF OMITTED] TR08NO19.039
The payment amounts for the various severity levels based on the
updated conversion factor for HHAs that do not submit quality data are
calculated in Table 22.
[GRAPHIC] [TIFF OMITTED] TR08NO19.040
In CY 2020, the NRS payment amounts apply to only those 60-day
episodes that begin on or before December 31, 2019, but span the
implementation of the PDGM and the 30-day unit of payment on January 1,
2020 (ending in CY 2020, on or before February 28, 2020). Under the
PDGM, NRS payments are included in the 30-day base payment rate.
d. CY 2020 National, Standardized 30-Day Period Payment Amount
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 2020 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.E. of this final rule with comment period.
To calculate the wage index budget neutrality factor, we simulated
total payments for non-LUPA 30-day periods
[[Page 60539]]
using the final CY 2020 wage index and compared it to our simulation of
total payments for non-LUPA 30-day periods using the CY 2019 wage
index. By dividing the total payments for non-LUPA 30-day periods using
the CY 2020 wage index by the total payments for non-LUPA 30-day
periods using the CY 2019 wage index, we obtain a wage index budget
neutrality factor of 1.0063. We would apply the wage index budget
neutrality factor of 1.0063 to the calculation of the CY 2020 national,
standardized 30-day period payment rate as described in section III.B.
of this rule.
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 is the first year of PDGM, a case-mix
budget neutrality factor is not applicable. 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 estimated change
in aggregate payments between the previous year's PDGM case-mix weights
and the recalibrated PDGM case-mix weights.
Next, we update the 30-day payment rate by the CY 2020 home health
payment update percentage of 1.5 percent as required by section 53110
of the BBA of 2018 and as described in section III.E. of this final
rule with comment period. The CY 2020 national, standardized 30-day
period payment rate is calculated in Table 23.
[GRAPHIC] [TIFF OMITTED] TR08NO19.041
The CY 2020 national, standardized 30-day episode payment rate for
an HHA that does not submit the required quality data is updated by the
CY 2020 home health payment update of 1.5 percent minus 2 percentage
points and is shown in Table 24.
[GRAPHIC] [TIFF OMITTED] TR08NO19.042
e. CY 2020 National Per-Visit Rates for Both 60-Day Episodes of Care
and 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 2020 national per-visit rates, we started with
the CY 2019 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 episodes using the CY 2020 wage
index and comparing it to simulated total payments for LUPA episodes
using the CY 2019 wage index. By dividing the total payments for LUPA
episodes using the CY 2020 wage index by the total payments for LUPA
episodes using the CY 2019 wage index, we obtained a wage index budget
neutrality factor of 1.0066. We apply the wage index budget neutrality
factor of 1.0066 in order to calculate the CY 2020 national per-visit
rates.
The LUPA per-visit rates are not calculated using case-mix weights.
Therefore, no case-mix weight 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 2020 home health payment
update percentage of 1.5 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 2020 national per-visit rates for HHAs that submit the required
quality data are updated by the CY 2020 HH payment update percentage of
1.5 percent and are shown in Table 25.
[[Page 60540]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.043
The CY 2020 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 1.5 percent minus 2 percentage points and are shown in
Table 26.
[GRAPHIC] [TIFF OMITTED] TR08NO19.044
Final Decision: We did not receive any comments on the CY 2020 home
health payment rate update for CY 2020. Therefore, we are finalizing
the 60-day episode payment rates for those episodes of care that span
the January 1, 2020 implementation date of the change to a 30-day unit
of payment; the 30-day period payment rates for periods of care
beginning on and after January 1, 2020; the CY 2020 per-visit payment
rates; and the home health update percentage to update the home health
payment rates for CY 2020 as proposed.
f. Rural Add-On Payments for CYs 2020 Through 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
[[Page 60541]]
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 2020 Through 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
associated with the publication of this rule is available in the
``Downloads'' section of the Home Health Prospective Payment System
Regulations and Notices web page. 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 the three rural add-on categories is available
for download on the same web page.
The HH PRICER module, located within CMS' claims processing system,
will increase the final CY 2020 60-day and 30-day base payment rates
described in section III.E. of this rule by the appropriate rural add-
on percentage prior to applying any case-mix and wage index
adjustments. The CY 2020 through 2022 rural add-on percentages outlined
in law are shown in Table 27.
[GRAPHIC] [TIFF OMITTED] TR08NO19.103
While we did not solicit comments on the rural add-on percentages
as these are mandated by the BBA of 2018, we did receive a few
comments, mainly from rural HHAs. These are summarized in this section
of this final rule with comment period.
Comment: MedPAC supports CMS's proposal that recognizes high-
utilization counties, low-population counties, and all other counties
to apply to rural add-on to remain in effect until CY 2022. MedPAC has
not found systematic issues with access to home health care in rural
areas nor concerns regarding rural home health margins. Furthermore,
CMS's rural add-on policy supports MedPAC's recommendation to target
rural payment adjustments to areas that have access challenges.
Response: We thank MedPAC for their support.
Comment: Several commenters recognized that the phase-out of the
rural add-on is based on the Bipartisan Budget Act of 2018 with no
latitude to revise the proposal. However, they suggested CMS take this
into consideration in relation to the 8.01 percent reduction in the
standardized 30-day rate to account for behavioral adjustments. Some
commenters indicate the phase-out of the rural add-on payment, coupled
with other payment system changes, would be difficult for rural HHAs to
fiscally manage. Commenters indicated that CMS should monitor the
impact of the phase-out (and determine if counties experience
demographic changes year to year) and publicly report findings. A
commenter recommended continued monitoring during the PDGM post-
implementation period in order to determine the impact on accessibility
to care and the ability of providers to fill open staffing positions.
Response: We understand commenter concerns about a phase-out of
rural add-on payments and potential effects on rural HHAs. However,
because the current rural add-on policy is statutory, we have no
regulatory discretion to extend it. Congress would need to change the
law. Additionally, section 1895(b)(3)(A)(iv) of the Act requires that
in calculating a 30-day payment amount in a budget-neutral manner, the
Secretary must make assumptions about behavior changes that could occur
as a result of the implementation of the 30-day unit of payment and the
new case-mix adjustment methodology. We remind commenters that the
overall impact of the PDGM, the 30-day unit of payment, and behavioral
assumptions is zero given the statutory requirement that these changes
are implemented in a budget-neutral manner. CMS will continue to
monitor patient access to home health services, as well as the costs
associated with providing home health care in rural versus urban areas,
and the impacts due to policy changes, including the changes in rural
add-on payments for CYs 2019 through 2022. We will provide the industry
with periodic updates on our analysis in rulemaking and/or
announcements on the HHA Center web page at: https://www.cms.gov/
Center/Provider-Type/Home-Health-Agency-HHA-Center.html.
Comment: Several commenters indicated that CMS should continue to
ensure beneficiaries living in rural areas have adequate access to the
home health benefit. Some commenters indicated
[[Page 60542]]
that CMS should consider providing coverage for telehealth services
related to therapy.
Response: We thank commenters for their suggestions as it relates
to telehealth services. 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 certified by a physician. Thus, virtual home health
visits would not qualify for payment under the home health benefit. We
will continue to examine the role of telehealth under the home health
benefit and will consider ways to more broadly support such technology
as a part of the home health benefit when used to augment the plan of
care, but not replace in-person visits.
Final Decision: Policies for the provision of rural add-on payments
for CY 2019 through CY 2022 were finalized in the CY 2019 HH PPS final
rule with comment period (83 FR 56443), in accordance with section
50208 of the BBA of 2018. The data used to categorize each county or
equivalent area are 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 the three rural add-on categories is
available for download. The CY 2020 through 2022 rural add-on
percentages outlined in law are shown in Table 27.
We are not making any changes to the policies previously finalized
in last year's rulemaking in this final rule with comment period.
g. Low-Utilization Payment Adjustment (LUPA) Add-On Factors and Partial
Payment Adjustments
Currently, LUPA episodes qualify for an add-on payment when the
episode is the first or only episode in a sequence of adjacent
episodes. As stated in the CY 2008 HH PPS final rule, LUPA add-on
payments are made because the national per-visit payment rates do not
adequately account for the front-loading of costs for the first LUPA
episode of care as 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 (83 FR 56440), 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 CY 2020 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 will be $276.17 (1.8451
multiplied by $149.68), subject to area wage adjustment.
Also in the CY 2019 HH PPS final rule with comment period (83 FR
56516), we finalized our policy that the process for partial payment
adjustments for 30-day periods of care will remain the same as the
process for 60-day episodes. The partial episode payment (PEP)
adjustment is a proportion of the period payment and is based on the
span of days including the start-of-care date (for example, the date of
the first billable service) through and including the last billable
service date under the original plan of care before the intervening
event in a home health beneficiary's care defined as a--
Beneficiary elected transfer, or
Discharge and return to home health that would warrant,
for purposes of payment, a new OASIS assessment, physician
certification of eligibility, and a new plan of care.
When a new 30-day period begins due to an intervening event, the
original 30-day period will be proportionally adjusted to reflect the
length of time the beneficiary remained under the agency's care prior
to the intervening event. The proportional payment is the partial
payment adjustment. The partial payment adjustment will be calculated
by using the span of days (first billable service date through and
including the last billable service date) under the original plan of
care as a proportion of the 30-day period. The proportion will then be
multiplied by the original case-mix and wage index to produce the 30-
day payment.
Final Decision: We did not receive any comments on the LUPA add-on
factors or partial payment adjustments. Therefore, as finalized in the
CY 2019 final rule with comment period, we will continue 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. We will also retain the current PEP policy and apply such policy
to 30-day periods of care under the PDGM.
F. 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
[[Page 60543]]
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 re-designating 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.
Tables 25 and 26 show the CY 2020 per-visit payment rates and we
will publish the cost-per-unit amounts for CY 2020 in the rate update
change request, which is issued after the publication of the CY 2020 HH
PPS final rule with comment period. 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 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. The calculation of the proposed fixed-
dollar loss ratio for CY 2020 for both the 60-day episodes that span
the implementation date, and for 30-day periods of care beginning on
and after January 1, 2020 is detailed in this section.
2. Fixed Dollar Loss (FDL) Ratio for CY 2020
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 episodes or 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 episodes or periods. Alternatively, a lower FDL
ratio means that more episodes or periods can qualify for outlier
payments, but outlier payments per episode or 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.
In the CY 2019 HH PPS final rule with comment period (83 FR 56439),
we finalized a FDL ratio of 0.51 to pay up to, but no more than, 2.5
percent of total payments as outlier payments. For CY 2020, we did not
propose to update the FDL ratio for those 60-day episodes that span the
implementation date of the PDGM and the change to a 30-day unit of
payment. For those 30-day periods of care in CY 2020, we proposed that
the FDL ratio would need to be set at 0.63 in order for outlier
payments not to exceed 2.5 percent of the total payments estimated to
be made under the HH PPS. In this final rule with comment period, we
updated the outlier estimates for 30-day periods of care beginning on
and after January 1, 2020 using updated claims data and the final CY
2020 payment rates outlined in section III.E.4 of this final rule with
comment period. 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, the FDL ratio for 30-day periods of care in CY
2020 would need to be set at 0.56 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. We note that we updated our estimate of
outlier payments as a percent of total HH PPS payments using the most
current and complete year of HH PPS data (CY 2018 claims data as of
July 31, 2019) and
[[Page 60544]]
therefore, the final FDL ratio has been updated accordingly.
Final Decision: We did not receive any comments on the proposed FDL
ratios for 60-day episodes of care that span the January 1, 2020
implementation date of the PDGM and the change to a 30-day unit of
payment or for 30-day periods of care. Therefore, we are finalizing the
FDL ratio of 0.51 for 60-day episodes and 0.56 for 30-day periods of
care for CY 2020.
G. Changes to the Split-Percentage Payment Approach for HHAs in CY 2020
and Subsequent Years
In the current HH PPS, there is a split-percentage payment approach
to the 60-day episode of care. The first bill, a Request for
Anticipated Payment (RAP), is submitted at the beginning of the initial
episode for 60 percent of the anticipated final claim payment amount.
The second, final bill is submitted at the end of the 60-day episode of
care for the remaining 40 percent. For all subsequent episodes for
beneficiaries who receive continuous home health care, the episodes are
paid at a 50/50 percentage payment split. RAP submissions are
operationally significant, as the RAP establishes the beneficiary's
primary HHA in the common working file (CWF) so that the claims
processing system can reject claims from providers or suppliers other
than the primary HHA for the services and items subject to consolidated
billing. As noted previously, section 1895(b)(2)(B) of the Act, as
added by section 51001(a) of the BBA of 2018, requires a change in the
unit of payment from a 60 days to 30 days, effective January 1, 2020.
As such, in the CY 2019 HH PPS proposed rule (83 FR 32391) and in this
year's CY 2020 HH PPS proposed rule (84 FR 34598), we discussed our
belief that the split percentage approach to payment may no longer be
needed for HHAs to maintain adequate cash flow.
In the CY 2019 HH PPS final rule with comment period (83 FR 56628),
we discussed the typical RAP fraud scenario where an HHA enrolls in
Medicare and proceeds to submit a large amount of RAPs in a short
timeframe, the provider never submits a final claim and then shuts down
the business before CMS is able to take action. In light of the
potential for this type of fraud scenario, and the move to a 30-day
unit of payment where HHAs can submit the final claim after 30 days, we
finalized that newly-enrolled HHAs that is HHAs certified for
participation in Medicare effective on or after January 1, 2019, will
not receive split-percentage payments beginning in CY 2020. HHAs that
are certified for participation in Medicare effective on or after
January 1, 2019, will still be required to submit a ``no pay'' Request
for Anticipated Payment (RAP) at the beginning of a period of care in
order to establish the home health period of care, as well as every 30
days thereafter. Existing HHAs, meaning those HHAs that are certified
for participation in Medicare with effective dates prior to January 1,
2019, would continue to receive split-percentage payments upon
implementation of the PDGM and the change to a 30-day unit of payment
in CY 2020. We finalized the corresponding regulations text changes at
Sec. 484.205(g)(2), which sets forth the policy for split-percentage
payments for periods of care on or after January 1, 2020.
In the CY 2020 HH PPS proposed rule (84 FR 34598), we described
more recent fraud schemes with existing providers where individuals or
groups with the intent of perpetuating fraud enter the program by
acquiring existing HHAs which allows them to circumvent Medicare's
screening and enrollment process. These individuals and groups purchase
existing agencies through Changes of Ownerships (CHOWs) and Changes of
Information, but fail to disclose ownership changes to CMS as required
by 42 CFR 424.516(e) and 489.18 (as applicable). If CMS identifies the
failure to report, it can revoke the enrollment of the HHA in the
Medicare program under 42 CFR 424.535(a)(1) (or under 42 CFR
424.535(a)(9) after the FY 2020 Program Integrity Enhancements to the
Provider Enrollment Process final rule with comment period (84 FR
47794) is effective on November 4, 2019). However, problematic
individuals or groups that engage in the above intentional reporting
failures may not always be identified and, thus, CMS may not be able to
remove the bad actors from the program in all relevant cases.
A situation like this, where an individual or group acquires
existing HHAs and does not appropriately disclose ownership
relationships to CMS, allows the individual or groups who have acquired
the HHA to evade the normal enrollment screening processes enabling
them to operate as if they are an existing provider. Situations like
this leave CMS blind to the potentially problematic criminal history of
the acquiring individual.
In order to address program integrity vulnerabilities for
situations like this, as well as those where providers enroll and flood
the system with RAPs solely to collect the upfront payment and never
submit a final claim, we proposed in the CY 2020 HH PPS proposed rule
(84 FR 34598) to lower the upfront split percentage payment from the
current 60/50 percent (depending on whether period of care is the
initial or subsequent period) to 20 percent in CY 2020 for both initial
and subsequent 30-day periods of care and proposed to eliminate RAPs
for all providers starting in CY 2021. Also, after the sunset of the
RAP policy in CY 2021, we proposed to require all HHAs to submit a one-
time NOA, within 5 calendar days from the start of care date, to
establish that the beneficiary is under a Medicare home health period
of care and also to trigger home health consolidated billing edits
required under section 1842(b)(6)(F) of the Act. Moreover, we proposed
that failure to submit a timely NOA, that is not submitting the NOA
within 5 calendar days from the start of care date, would result in a
reduction to the 30-day Medicare payment amount. We proposed that
Medicare would not pay for days of home health services from the start
of care date to the NOA filing date if the NOA was submitted after the
5 calendar day deadline. Likewise, we proposed that for periods of care
in which an HHA fails to submit a timely NOA, no LUPA payments would be
made for days that fall within the period of care prior to the
submission of the NOA. We also proposed that if an exceptional
circumstance is experienced by the HHA, CMS may waive the consequences
of failure to submit a timely-filed NOA. Lastly, we proposed
corresponding regulation text changes at Sec. 484.205.
The following is a summary of the public comments received on the
``Split Percentage Payment Approach for a 30-day Unit of Payment'' and
the ``Notice of Admission'' proposals and our responses:
Comment: Most commenters did not support the phase-out of the split
percentage payment and suggested that CMS not change its current
policy. Other commenters stated that CMS was implementing too many
policy changes at once and requested additional time for
implementation. Some commenters remarked that RAPs should continue
under the PDGM to ensure there is no disruption in cash flow for
providers as that would be harmful to their business. Other commenters
stated that a split percentage payment phase-out should be postponed
for HHAs in states that require Review Choice Demonstration (RCD)
participation. There was also some commenter support to phase-out the
split percentage payment over a multi-year period, starting at least
one year after the implementation of the PDGM, in order to allow
agencies of
[[Page 60545]]
various sizes and geographical designations to appropriately adapt to
PDGM.
Response: We continue to believe that as a result of the change in
the unit of payment from a 60-day episode of care to a 30-day period of
care, that a split percentage approach to payment may not be needed for
HHAs to maintain an adequate cash flow. With monthly billing, HHAs have
the ability to receive ongoing cash flow which we believe would
mitigate concerns over having adequate funds for the provision of care,
no matter the size or geographical designation of the HHA. We note that
for the first year of the PDGM in CY 2020, providers will still receive
a RAP payment of 20 percent which should help transition existing
providers to the new payment system. We also believe that the eventual
phase-out of RAPs will significantly streamline claims processing for
HHAs as they would not be submitting a RAP for each 30-day period of
care and instead would submit a one-time NOA. Also, HHAs have
capitalization requirements which requires the agency to have available
sufficient funds at the time of applying for enrollment in Medicare, at
all times during the enrollment process, and during the 3-month period
following the conveyance of Medicare billing privileges to the HHA. A
multi-year phase-out approach, which some commenters suggest, would not
help streamline claims processing for providers nor would it address
the ongoing program integrity issues that we have discussed in the CY
2019 HH PPS proposed and final rules (83 FR 32391 and 83 FR 56462,
respectively) and in this year's CY 2020 HH PPS proposed rule (84 FR
34638). A multi-year approach would just continue to subject the
Medicare Trust Fund to additional fraud schemes in relation to the
submission of RAPs. However, we will continue to monitor HHA adaptation
for the split percentage phase-out with the implementation of the PDGM,
and may decide whether additional adjustments are necessary in future
rulemaking if an access to care issue arises.
Comment: Many commenters had concerns that CMS was modifying its
RAP policy due to abuse by certain agencies. Commenters suggested that
CMS should utilize their ability to restrict RAPs for agencies that
abuse it instead of modifying the current RAP policy. Other commenters
stated that because CMS recoups the majority of RAP overpayments, RAP
policy changes were unneeded. Some commenters indicated that not all
cases where a final claim is not submitted after a RAP are abusive and
that CMS should address actual abuse using tools such as post payment
review and audits. Commenters encouraged CMS to identify the agencies
that are abusing the system and to impose more oversight through
accrediting organizations and the MACs. A commenter raised their
concern that removal of RAPs would increase incidents of ``cherry
picking.''
Response: While one of the reasons for the elimination of RAPs is
to potentially stem program integrity vulnerabilities, it is not the
sole reason. We remind commenters that the current median length of
days for RAP submission is 12 days from the start of the 60-day episode
of care. With a change in the unit of payment to a 30-day period of
care, if this median length of days for RAP submissions remains
constant, there is the possibility that HHAs could be simultaneously
submitting a RAP and a final claim for each 30-day period of care. We
believe that this defeats the purpose of the RAP to maintain adequate
cash flow and only increases complexity for HHAs in their claims
processing. With monthly billing, HHAs have the ability to receive an
ongoing cash flow which we believe would mitigate concerns over having
adequate funds for the provision of care.
CMS's use of post payment audit and review as a means to address
abuse is not an appropriate intervention to prevent fraudulent or
improper behavior because these are ``pay and chase'' solutions to a
problem that demands preventive action. Post payment review and other
auditing approaches are not always cost effective and as described in
the proposed rule, they, by definition, are susceptible to significant
program integrity abuses. We are moving beyond the pay and chase
approach to program integrity structural changes wherever possible for
all provider settings. To base our approach to home health program
integrity on a pay and chase framework simply does not achieve the
protections we need to have in place. Post payment audits and other
post payment recoupment processes are not an acceptable modern
technological solution for ensuring proper payment in the home health
environment.
We acknowledge and appreciate the concerns commenters have raised
with regards to abuse of the RAP policy by certain HHAs. We plan to
continue to closely monitor RAP submissions, service utilization,
payment, and quality trends which may change as a result of
implementing of the PDGM and a 30-day unit of payment. If changes in
practice and/or coding patterns or RAPs submissions arise, we may take
further action, which may include administrative action against
providers as appropriate and/or proposing changes in policy. We will
also continue to work with the HHS Office of Inspector General as cases
of potential provider fraud and abuse are identified.
Comment: A commenter requests CMS to clarify or identify the
responsible party in a change of ownership (CHOW) when the RAP is
eliminated. Another commenter stated their belief that agencies
submitting RAPs would not have a limitless supply of cash and provided
questions that, when answered, would pierce corporate protections and
allow for civil prosecution.
Response: A change in ownership of a HHA does not change the RAP
requirements. All home health agencies, including those that have
undergone a change in ownership, will be subject to the elimination of
RAPs when it occurs in CY 2022. Also, we believe that the new RAP
policy does nothing to change any corporate protections or the rules
regarding civil prosecution that exist currently.
The need for regulatory change to phase-out RAPs for existing
providers is well supported by the spike in RAP fraud schemes
perpetrated by existing providers. As discussed in the CY 2020 HH PPS
proposed rule (84 FR 34598), the following are examples of HHAs that
were identified for billing large amounts of RAPs after a CHOW, or the
acquisition of an existing agency, from 2014 to the present.
Example 1: One prior investigation illustrates an individual intent
on perpetrating the HH RAP fraud who took advantage of the acquisition
of an existing agency. The investigation was initiated based on a lead
generated by the Fraud Prevention System (FPS). Per the Provider
Enrollment, Chain and Ownership System (PECOS), the provider had an
effective date that was followed by a CHOW. The investigation was aided
by a whistleblower coming forward who stated that the new owners of the
agency completed the transaction with the intent to submit large
quantities of fraudulent claims with the expressed purpose of receiving
inappropriate payment from Medicare. Notwithstanding the quick actions
taken to prevent further inappropriate payments, the fraud scheme
resulted in improper payments of RAPs and final claims in the amount of
$1.3 million.
Example 2: One investigation involved a HHA located in Michigan
that submitted home health claims for beneficiaries located in
California and Florida. Further analysis found that, after a CHOW, the
HHA submitted RAPs with no final claims. CMS discovered
[[Page 60546]]
that the address of record for the HHA was vacant for an extended
period of time. In addition, we determined that although the HHA had
continued billing and receiving payments for RAP claims, it had not
submitted a final claim in 10 months. Ultimately, the HHA submitted a
total of $50,234,430 in RAP claims and received $37,204,558 in RAP
payments.
Example 3: A HHA submitted a significant spike in the number of
RAPs following an ownership change. The investigation identified that
in the period following the CHOW there were RAP payments totaling $12
million and thousands of RAPs that were submitted for which apparently
no services were rendered.
Example 4: An Illinois HHA was identified through analysis of CHOW
information. Three months after, the HHA had a CHOW, and the provider
subsequently submitted a spike in RAP suppressions. All payments to the
provider were suspended. Notwithstanding, the provider was paid $3.6
million in RAPs.
Although CMS has attempted to address these vulnerabilities through
extensive monitoring, audits and investigations, there continue to be
cases of individual HHAs causing large RAP fraud losses. Recently, a
September 27, 2019 DOJ press release highlighted a number of charges
brought against individuals involved in certain health care fraud
schemes: https://www.justice.gov/opa/pr/midwest-health-care-fraud-law-enforcement-action-results-charges-against-53-individuals. We consider
these fraudulent improper payments a significant vulnerability to the
Medicare Trust Funds. We continue to believe that we need proactive
interventions and approaches to prevent these kinds of events from
happening, and that the financial impact to HHAs will be minimal under
the change from a 60-day to 30-day episode of care. Likewise, we
believe that the RAP phase-out and eventual elimination of split-
percentage payments would serve to mitigate potential fraud schemes
while minimally impacting HHAs due to the switch to a 30-day unit of
payment.
Comment: A few commenters expressed support for the NOA and
recognized that the NOA would be necessary to alert the claims
processing system of a home health period of care due to the required
consolidated billing requirements. Other commenters stated that the use
of a NOA would place burden on HHAs in the form of additional
paperwork/coordination, and that the NOA requirements were excessive
and CMS should consider not requiring HHAs to complete the OASIS or
acquiring a signed plan of care before accepting the NOA. Some
commenters indicated that the only information that should be required
to submit the NOA are items like the ``beneficiary's name and a start
of care date'' and/or a verbal order to begin care. A commenter
suggested that the NOA be optional in CY 2021 and mandatory in CY 2022.
Response: We thank those commenters for their support and
recognition of the need for a NOA. Specifically, we agree that having a
one-time submission of a NOA within 5 calendar days of the start of
care, establishing that the beneficiary is under a Medicare home health
period of care, will cut down on claims denials, help trigger
consolidated billing edits sooner and may streamline claims processing
for HHAs. The NOA also provides other HHAs the capability to determine
if a beneficiary is already under a Medicare home health period of
care; thereby, reduces the administrative burden associated with
determining a beneficiary's period of care, reimbursement cancelations,
and general beneficiary coordination issues. After reviewing all of the
comments received regarding the information needed to submit the NOA,
we agree with commenters that since the NOA does not have a payment
tied to its submission, the requirements to fulfill the NOA should not
mirror the requirements associated with the submission of a RAP. As
such, we agree with commenters that the NOA submission criteria should
require only the necessary information needed to begin Medicare home
health services for the beneficiary. Therefore, the only information we
will require for the NOA, starting in CY 2022, will be: (1) A written
or verbal order from the physician (containing the services required
for the initial visit) signed and dated by the physician, and if
verbal, signed and dated by the registered nurse or qualified therapist
(as defined in Sec. 484.115) responsible for furnishing or supervising
the ordered service in the plan of care signed by the physician; and
(2) for the HHA to conduct the initial start of care visit. We believe
these requirements represent the minimum amount of information that is
sufficient for establishing a home health period of care and is
information that the home health agency would already have as part of
the medical record for beneficiaries admitted to home health.
Comment: Some commenters requested that CMS consider adopting a
simple mechanism for timely notification, such as requiring HHAs to
make notations in the CWF or through the EDI. Other commenters stated
that submitting a NOA within 5 calendar days from the start of care is
problematic and that many HHAs would be unable to meet that short
timeframe. Instead of the 5 calendar day timely filing requirement,
some commenters suggested lengthening the timeframe to 10-14 calendar
days to submit a NOA. Other commenters recommended that CMS postpone
the NOA requirements until CY 2022 or later, to allow HHAs time to
adjust to the new PDGM 30-day unit of payment.
Response: There is currently no mechanism that would allow
providers the ability to make any kind of notation in the CWF. Even if
the creation of such a mechanism was feasible, the program integrity
concerns of allowing providers to make their own notations in CWF would
be exchanging one program integrity vulnerability (the upfront RAP
payments) for another (allowing providers to make their own notations
in the CWF). A NOA is needed to identify the initial home health period
of care for each beneficiary after the elimination of RAPs. Failure to
provide such notification, (which triggers the home health consolidated
billing edits and establishes the home health period of care in the
CWF), could lead to an increase in claims denials. Moreover, not having
an NOA potentially could result in an increase in appeals and an
increase in situations where other providers, including other HHAs,
would not have easily accessible information on whether a patient was
already being treated by another provider. As we envision it, the home
health NOA process would be operationalized through an EDI submission,
similar to that used for submission of the hospice Notice of Election
(NOE). The purpose of an EDI submission, for NOEs for hospice or NOAs
for home health, is to minimize data entry errors. Because there is
already a Medicare claims processing notification, for benefit
admission, in place, we believe that this should make the home health
NOA process more consistent and timely for HHAs. Additionally, the use
of a one-time NOA would streamline HHAs claims processing as the need
for submitting a RAP for every period of care would be eliminated. The
HHA would only be submitting the NOA once at the start of care which
would minimize provider administrative burden for each beneficiary whom
the HHA provides home health services.
Concerning the 5 calendar day timely-filing requirement, CMS
considered different time frames for the submission of the one-time
NOA, including a 7 calendar day timeframe in which to submit a timely-
filed NOA. However, to
[[Page 60547]]
be consistent with similar requirements in other settings (for example,
in hospice where the NOE must be submitted within 5 calendar days), we
believe the 5 calendar day timely-filing requirement would ensure that
the Medicare claims processing system is alerted as soon as possible to
mitigate any potential claims denials of other providers for services
that should be covered under the home health benefit. Furthermore, the
longer the NOA submission timeframe, the higher the uncertainty for
providers to determine home health periods of care for a beneficiary.
Having a policy for submitting a NOA within 5 calendar days, when
compared to the commenter suggested 10-14 calendar days, will create an
environment where there is less confusion and administrative burden for
HHAs, when determining home health periods of care. After reviewing
comments, we have decided to limit the requirements to submit the NOA
to only require a verbal order from the physician (containing the
services required for the initial visit) signed and dated by the
registered nurse or qualified therapist (as defined in Sec. 484.115)
responsible for furnishing or supervising the ordered service in the
plan of care signed by the physician, and that the HHA conduct the
start of care visit. Also, in response to comments received, as well as
CMS operational issues, we will delay the implementation of the NOA
requirement until CY 2022, and instead will require that HHAs submit a
``no-pay'' RAP for CY 2021. However, for CY 2021, HHAs would be
required to submit the ``no-pay'' RAP within five calendar days after
the start of each 30-day period of care as this would have been the
requirement for the NOA, if the NOA requirement would have been
finalized for 2021. Furthermore, in alignment with the proposed NOA
process, we will also apply a reduction to home health payment if the
``no-pay'' RAP is not submitted timely. That is, there will be a non-
timely submission reduction in payment amount tied to late submission
of any ``no-pay'' RAPs when the HHA does not submit the RAP within 5
calendar days from the start of care date for the first 30-day period
of care in a 60-day certification period and within 5 calendar days of
day 31 for the second 30-day period of care in the 60-day certification
period. This reduction in payment amount would be calculated the same
way as the NOA non-timely filing policy where the reduction in payment
amount would be equal to a \1/30\th reduction to the wage-adjusted 30-
day period payment amount for each day from the home health start of
care date until the date the HHA submits the ``no-pay'' RAP. We are
adopting such changes under a ``good cause'' waiver of proposed
rulemaking (see section VII. of this final rule with comment period).
Comment: A number of commenters opposed CMS' proposal to impose a
financial penalty on HHAs for failing to submit a timely NOA and
instead recommended that CMS consider making the notice of admission a
survey requirement in the future. A commenter strongly urged that the
NOA submission component be thoroughly vetted with input from
providers, EHR vendors, MACs; and another recommended that CMS provide
education to assist home health providers with appropriately adapting
to all changes.
Response: Currently the RAP establishes an HHA as the primary HHA
for the beneficiary during that timeframe and also alerts the claims
processing system that a beneficiary is under a home health episode and
triggers the consolidated billing edits required by law under section
1842(b)(6)(F) of the Act. Also, under the current structure of the RAP,
providers receive an upfront split-percentage payment upon submission
of the RAP, providing an incentive for submitting the RAP as early as
possible, which also ensures the triggering of the consolidated billing
edits. Without a potential payment impact associated with the
submission of a NOA, the HHA could submit the NOA when they submit
their final claim, which would delay turning on the consolidated
billing edits, thus having an adverse effect on other providers
providing services to a beneficiary that were likely unaware that the
beneficiary was already under a home health episode of care. Therefore,
we believe that having a penalty or a reduction in the payment amount
for NOAs submitted after the 5 calendar day timely filing requirement
is appropriate to aid in expediting the submission of the NOA,
triggering consolidated billing edits as soon as possible and reducing
claim rejections for other providers who are providing care for a
beneficiary who is already under a home health episode. Additionally,
our proposal to assess a financial reduction in payment amount for late
NOA submission is in alignment with current hospice policy for timely
submission of the hospice Notice of Election (NOE). Hospices are paid a
bundled per diem payment amount for each day a beneficiary is under a
hospice election. If the hospice NOE is not submitted timely (that is,
within five calendar dates of the date of election), Medicare will not
cover and pay for the days of hospice care from the hospice admission
date to the date the NOE is submitted to the Medicare contractor. We
have found the reduction in payment amount for failure to submit an NOE
to be an effective tool in ensuring timely NOE submission and believe
it would be appropriate to apply a similar policy to home health. As
proposed in the CY 2020 HH PPS proposed rule (84 FR 34640), if an HHA
failed to submit a timely NOA, the reduction in payment amount would be
equal to a \1/30\th reduction to the wage-adjusted 30-day period
payment amount for each day from the home health start of care date
until the date the HHA submitted the NOA. For example, if an HHA
submits their NOA one day late (with an NOA submission 6 days after the
start of care), the result would be a 20 percent reduction to the 30-
day payment amount. Also, if an HHA submits their NOA 25 days late
(with an NOA submission 30 days after the start of care), there would
be a 100 percent reduction to the payment The reduction in payment
amount (R) to the full 30-day period payment amount would be calculated
as follows:
Step 1: The number of calendar days (d) from the start of
care until the NOA is submitted divided by 30 days;
Step 2: The fraction from step 1 is multiplied by the
case-mix and wage adjusted 30-day period payment amount (P).
The formula for the reduction in payment amount would be R = (d/30)
x P.
We proposed that there would be no NOA reduction in payment amount
if the NOA is submitted timely (that is, within the first 5 calendar
days starting with the start of care date). Likewise, for periods of
care in which an HHA fails to submit a timely NOA, no LUPA payments
would be made for days that fall within the period of care prior to the
submission of the 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. Once the NOA is received, all claims for both initial and
subsequent episodes of care would compare the receipt date of the NOA
to the HH period of care start date to determine whether a late NOA
reduction applies. This will be an automated process performed by the
claims processing system.
We disagree with the commenters' suggestion to make the NOA a
survey requirement as the NOA, like the current RAP, serves to identify
that the beneficiary is under a home health period of care and trigger
consolidated
[[Page 60548]]
billing edits and to establish the home health period of care in the
Medicare claims processing system. Survey requirements are to ensure
health and safety standards in accordance with the home health CoPs;
whereas, the NOA serves a claims processing function for payment.
Therefore, we believe tying the NOA timely submission requirement to
payment is appropriate to mitigate any potential denial/recoupment
issues that might occur if other providers file claims for providing
services to a beneficiary under a home health period of care before a
NOA is submitted.
In the CY 2019 HH PPS proposed rule (83 FR 32390), as well as in
this year's CY 2020 HH PPS proposed rule (84 FR 34639), we solicited
for comments on the need for HHAs to submit an NOA within 5 calendar
days from the start of care to capture that HHA as the primary agency
for the beneficiary during their home health episode of care. The
comments we received from both the CY 2019 and 2020 HH PPS proposed
rules aided in the development of our final NOA policy. We appreciate
the careful review of the NOA policy and the feedback we received.
Given that the NOA process will be new for HHAs, we will provide
education and develop materials for guidance on the NOA policy,
including MLN Matters[supreg] articles and manual guidance.
Comment: A commenter stated their concerns regarding the how the
NOA policy would apply in situations where beneficiaries have a
Medicare Advantage Plan but changes coverage to traditional Medicare
during open enrollment or when the patient qualifies for a special
enrollment while receiving home health services under an existing plan
of care.
Response: In this scenario, the HHA would likely fall into one of
the established timely filing exceptions for NOAs. To pursue this
potential exception, the HHA would file for an exception with their MAC
to request a waiver of the timely filing requirement associated with
submitting the NOA. If the MAC determines that the circumstance meets
the criteria for an exception, the HHA would receive the full 30-day
payment amount despite filing the NOA more than 5 calendar days after
the start of care.
Comment: Commenters expressed concern regarding all of the changes
occurring in CY 2020 with implementation of the PDGM and transitioning
to a 30-day unit of payment and these commenters stated HHAs will not
have sufficient time to make additional changes to their software
systems and business processes to accommodate a NOA process in CY 2021.
Commenters questioned whether the Medicare claims processing system
would be ready for a NOA process in CY 2021 and cited past issues with
the hospice NOE process.
Response: We appreciate commenter concerns about instituting a NOA
process in CY 2021 after having to make other system changes to
accommodate the PDGM and a 30-day unit of payment in CY 2020. Likewise,
we recognize operational issues with the Medicare claims processing
system that may make a CY 2021 implementation date overly ambitious.
Specifically, because of the way the current claims processing system
is developed, any final claim submitted for payment must reconcile to a
RAP or the claim will be denied. Because of the changes that would be
required to perform this function, we are not able to do a redesign of
the claims processing system so that a final claim is processed without
matching it to a RAP in time for CY 2021 implementation. Therefore, we
will delay implementation of a NOA process until CY 2022 in order to
redesign the claims processing system to ensure accurate final claim/
RAP matching.
We also agree that we want the home health NOA process to implement
in a way where submission errors are minimized. The intent of a NOA
process is not to be punitive to providers and we believe that delaying
implementation of a NOA process until CY 2022 will allow sufficient
time for both HHA and Medicare systems to be modified to accommodate
submission of the NOA while mitigating any unintended consequences.
Final Decision: We are finalizing the following policies as they
relate to split-percentage payments, Requests for Anticipated Payment
(RAPs), and submission of a Notice of Admission (NOA):
For CY 2020:
We are finalizing the proposal to decrease the upfront split-
percentage payment for 30-day periods of care beginning on and after
January 1, 2020 from 60/50 percent (depending on whether the period of
care is the initial or subsequent period) to 20 percent for each 30-day
period, for existing HHAs, meaning HHAs certified for participation in
Medicare effective on or before December 31, 2018. We remind commenters
that in the CY 2019 HH PPS final rule with comment period (83 FR
56463), we finalized a policy that newly-enrolled HHAs (that is, those
HHAs certified for participation in Medicare on or after January 1,
2019) will not receive split-percentage payments for periods of care
beginning on or after January 1, 2020 and are required to submit a
``no-pay'' RAP for each 30-day period of care.
For CY 2021:
We are finalizing to lower the split-percentage payment to zero for
all HHAs (that is, existing HHAs as well as newly-enrolled HHAs who
receive no split-percentage payments in CY 2020) and for all 30-day
periods of care beginning on or after January 1, 2021. For CY 2021, all
HHAs will submit a ``no-pay'' RAP at the beginning of each 30-day
period to allow the beneficiary to be claimed in the CWF and also to
trigger the consolidated billing edits. This means that existing HHAs
(those certified for participation in Medicare on or before December
31, 2018) will have their initial split-percentage payment reduced from
20 percent in CY 2020 to zero percent in CY 2021 for all 30-day periods
of care and will submit a ``no-pay'' RAP for all 30-day periods of care
in CY 2021. Newly enrolled HHAs (those certified for participation in
Medicare on or after January 1, 2019) will continue to submit ``no-
pay'' RAPs at the beginning of a 30-day period of care in order to
establish the home health period of care, as well as every 30 days
thereafter in CY 2021. Therefore, in CY 2021 all HHAs (both existing
and newly-enrolled HHAs) will submit a ``no pay'' RAP until RAP
elimination and the implementation of the one-time NOA policy in CY
2022.
However, the ``no-pay'' RAP for all HHAs in CY 2021 will require
less information before the RAP can be submitted. Since we are removing
the upfront payment associated with the RAP, we are relaxing the
required information needed to submit the ``no-pay'' RAP. Starting in
CY 2021, we are finalizing a policy that the information needed to
submit a ``no-pay'' RAP will mirror the NOA policy we are finalizing in
this rule. Specifically, we are finalizing a policy that submission of
``no-pay'' RAPs can be made when the following criteria have been met:
(1) The appropriate physician's written or verbal order that sets
out the services required for the initial visit has been received and
documented as required at Sec. Sec. 484.60(b) and 409.43(d);
(2) The initial visit within the 60-day certification period must
have been made and the individual admitted to home health care.
We are also finalizing a provision which will allow the advance
submission of certain RAPs in CY 2021 such that in instances where the
plan of care dictates that multiple 30-day periods of care will be
required to effectively treat the beneficiary, we will allow the HHA to
submit both the RAP for the first 30-day period of care and
[[Page 60549]]
the RAP for the second 30-day period of care (for a 60-day
certification) at the same time to help further reduce provider
administrative burden. Additionally, for CY 2021, we are finalizing a
policy where there will be a non-timely submission reduction in payment
amount tied to late submission of any ``no-pay'' RAPs when the HHA does
not submit the RAP within 5 calendar days from the start of care date
for the first 30-day period of care in a 60-day certification period
and within 5 calendar days of day 31 for the second 30-day period of
care in the 60-day certification period. This reduction in payment
amount would be calculated the same way as the NOA non-timely filing
policy where the reduction in payment amount would be equal to a \1/
30\th reduction to the wage-adjusted 30-day period payment amount for
each day from the home health start of care date until the date the HHA
submits the ``no-pay'' RAP. We are also finalizing exceptions to the
timely filing consequences of the RAP requirements. The RAP timely-
filing policies are in alignment with the substance of the timely-
filing NOA provisions proposed in the CY 2020 proposed rule (84 FR
34639).
For CY 2022:
Starting in CY 2022, we are finalizing that submission of RAPs will
be eliminated and instead we are finalizing the implementation of a
one-time NOA submission policy for all HHAs. We are finalizing a policy
that all HHAs must submit a NOA to their Medicare contractor within 5
calendar days from the start of care date. The NOA is a one-time
submission to establish the home health period of care and covers
contiguous 30-day periods of care until the individual is discharged
from Medicare home health services. We are also finalizing that NOA
submission criteria will require HHAs having a verbal or written order
from the physician that contains the services required for the initial
visit, and that the HHA has conducted an initial visit at the start of
care. We are finalizing that there will be a non-timely submission
reduction in payment amount tied to any late submission of NOAs when
the HHA does not submit the NOA within 5 calendar days from the start
of care. That is, if an HHA failed to submit a timely NOA, the
reduction in payment amount would be equal to a \1/30\th reduction to
the wage-adjusted 30-day period payment amount for each day from the
home health start of care date until the date the HHA submitted the
NOA. We are also finalizing exceptions to the timely filing
consequences of the NOA requirements. Moreover, we are finalizing the
corresponding regulation text changes at Sec. 484.205 to effectuate
these split-percentage payment, RAP and NOA policies.
Finally, as we noted in the CY 2020 HH PPS proposed rule, after
publication of the CY 2019 HH PPS final rule with comment period, we
note that there was an error in titling of the regulations text changes
associated with Sec. 484.205(g)(2) when the CY 2019 HH PPS final rule
with comment period went to the Federal Register. Specifically,
paragraph (g)(2)(iii) was incorrectly titled ``Split percentage
payments on or after January 1, 2019''. The title of this paragraph
implies that split percentage payments are not made to newly-enrolled
HHAs beginning on or after January 1, 2019, which is contradictory to
the finalized policy on split percentage-payments for newly enrolled
HHAs. We finalized a policy in the CY 2019 final rule with comment
period that newly-enrolled HHAs will not receive split-percentage
payments beginning in CY 2020. As such, in the CY 2020 proposed rule,
we proposed to make a correction to the regulations text title to
accurately reflect the finalized policy that newly-enrolled HHAs will
not receive split-percentage payments beginning in CY 2020. We did not
receive any comments on this proposed change. However, because of
proposed revisions to split-percentage payments in the CY 2020 proposed
rule, the finalized revised title correction, previously at paragraph
(g)(2)(iii), has been redesignated to Sec. 484.205(g)(2)(ii). The full
revisions to the text at Sec. 484.205 are found in the regulations
text section of this final rule with comment period. We are adopting
both the revised title change from the CY 2019 HH PPS final rule with
comment period and the finalized changes in this final rule with
comment period under a ``good cause'' waiver of proposed rulemaking as
the final policy mirrors that of the proposed NOA policy.
We note that the regulation at Sec. 484.205(g)(2)(ii), as it
relates to split percentage payments for newly-enrolled HHAs under the
HH PPS beginning in CY 2020, is separate from the placement of new HHAs
into a provisional period of enhanced oversight under the authority of
section 6401(a)(3) of the Affordable Care Act, which amended section
1866(j)(3) of the Act. The provisional period of enhanced oversight
became effective in February 2019. More information regarding the
provisional period of enhanced oversight can be found in the February
15, 2019 MLN Matters article: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19005.pdf.
H. Regulatory Change To Allow Therapist Assistants To Perform
Maintenance Therapy
In the CY 2020 HH PPS proposed rule (84 FR 34640) we recognized
that, while a therapist assistant is able to perform restorative
therapy under the Medicare home health benefit, the regulations at
Sec. 409.44(c)(2)(iii)(C) state that only a qualified therapist, and
not an assistant, can perform maintenance therapy. We explained that
although Medicare allows for skilled maintenance therapy in a SNF and
other outpatient settings, the type of clinician that can provide the
therapy services varies by setting. In some settings both the therapist
and the therapist assistant can deliver the skilled maintenance therapy
services, and in other settings, only the therapist can deliver the
skilled maintenance therapy services. For example, Medicare regulations
allow therapist assistants to provide maintenance therapy in a SNF, but
not in the home health setting. We noted that commenters on the CY 2019
Physician Fee Schedule final rule (83 FR 59654) expressed concerns
about shortages of therapists. That rule also finalized payment for
outpatient therapy services for which payment is made for services that
are furnished by a therapist assistant.
Therefore, we stated that we believe it would be appropriate to
allow therapist assistants to perform maintenance therapy services
under a maintenance program established by a qualified therapist under
the home health benefit, if acting within the therapy scope of practice
defined by state licensure laws. We clarified that the qualified
therapist would still be responsible for the initial assessment; plan
of care; maintenance program development and modifications; and
reassessment every 30 days, in addition to supervising the services
provided by the therapist assistant. We stated that this would allow
home health agencies more latitude in resource utilization, and
potentially address the concern regarding therapist shortages in home
health. We also noted that allowing assistants to perform maintenance
therapy would be consistent with other post-acute care settings,
including SNFs. As such, we proposed to modify the regulations at Sec.
409.44(c)(2)(iii)(C) to allow therapist assistants (rather than only
therapists) to perform maintenance therapy under the Medicare home
health benefit.
We solicited comments regarding this proposal and welcomed feedback
on whether this proposal would require
[[Page 60550]]
therapists to provide more frequent patient reassessment or maintenance
program review when the services are being performed by a therapist
assistant. We also solicited comments on whether we should revise the
description of the therapy codes to indicate maintenance services
performed by a physical or occupational therapist assistant (G0151 and
G0157) versus a qualified therapist, or simply remove the therapy code
indicating the establishment or delivery of a safe and effective
physical therapy maintenance program, by a physical therapist (G0159).
And finally, we welcomed comments on the importance of tracking whether
a visit is for maintenance or restorative therapy or whether it would
be appropriate to only identify whether the service is furnished by a
qualified therapist or an assistant in addition to any possible effects
on the quality of care that could result by allowing therapist
assistants to perform maintenance therapy.
The following is a summary of the comments received and our
responses to comments on the proposed regulatory change to allow
therapist assistants to perform maintenance therapy:
Comment: All commenters were supportive of the proposal to change
the regulations at Sec. 409.44(c)(2)(iii)(C) to allow therapist
assistants to perform maintenance therapy under the home health
benefit. Commenters stated that, as therapist assistants provide
skilled professional services in the home, are licensed in practice,
and are bound by the same ethical standards as therapists, assistants
are qualified to provide maintenance therapy. Additionally, commenters
stated that allowing HHAs to utilize therapist assistants within their
scope of practice to provide maintenance therapy as well as restorative
therapy, will support continued access to therapy services and improve
overall quality of care.
Response: We thank commenters for their support of this proposal to
allow therapist assistants to practice at the top of their licensure as
well as allowing HHAs the flexibility to ensure beneficiary access to
all available levels of therapy and resources.
Comment: Several commenters noted that the proposed rule and
regulations text referenced ``physical therapist assistants'' and
requested clarification regarding whether proposed Sec.
409.44(c)(2)(iii)(C) allows all therapist assistants (physical,
occupational, and speech-language pathology) to perform maintenance
therapy.
Response: The proposed changes at Sec. 409.44(c)(2)(iii)(C) would
allow therapist assistants from all therapy disciplines to perform
maintenance therapy within their scope of practice. The reference to
physical therapist assistants in the preamble language was an example
used to highlight, in general, licensure requirements for therapist
assistants. However, the example was in regard to the regulations at
Sec. 484.115(g) and (i), which is in reference to the personnel
qualifications of both occupational and physical therapist assistants.
We thank the commenters for pointing out that the regulations text
however, only referenced physical therapist assistants, and note that
Sec. 409.44(c)(2)(iii)(C)(1) and (2) has been changed to ``therapist
assistants,'' and not ``physical therapist assistants.'' We thank
commenters for their careful review of this proposal and for pointing
out this important clarification.
Comment: Commenters provided mixed recommendations regarding the
importance of tracking whether a visit is for maintenance or
restorative therapy and whether the service is furnished by a qualified
therapist or a therapist assistant. A few commenters stated that this
data would be relevant to future discussions on changes in intensity/
duration of therapy services delivered under the Patient-Driven
Groupings Model. Other commenters noted that, as both therapists and
therapist assistants are considered ``qualified'' and provide skilled
care, it would not be necessary to collect this information. And
finally we received a few comments stating that allowing therapist
assistants to perform maintenance therapy would not require the
supervising therapist to provide more frequent assessments, as this
provision would align the requirement with the existing standard in
other settings and for restorative therapy under home health.
Response: We thank all commenters for their recommendations and
will take all comments under consideration for future rule-making and
analysis.
Final Decision: We are finalizing our proposal to allow therapist
assistants to perform maintenance therapy under the home health
benefit. We are finalizing the proposed regulations text at Sec.
409.44(c)(2)(iii)(C)(1) and (2) with a modification to reflect that all
therapist assistants, rather than only physical therapist assistants,
can perform maintenance therapy.
I. Changes to the Home Health Plan of Care Regulations at Sec. 409.43
As a condition for payment of Medicare home health services, the
regulations at Sec. 409.43(a), home health plan of care content
requirements, state that the plan of care must contain those items
listed in Sec. 484.60(a) that specify the standards relating to a plan
of care that an HHA must meet in order to participate in the Medicare
program. The home health CoPs at Sec. 484.60(a) set forth the content
requirements of the individualized home health plan of care. In the
January 13, 2017 final rule, ``Medicare and Medicaid Program:
Conditions of Participation for Home Health Agencies'' (82 FR 4504), we
finalized changes to the plan of care requirements under the home
health CoPs by reorganizing the existing plan of care content
requirements at Sec. 484.18(a), adding two additional plan of care
content requirements, and moving the plan of care content requirements
to Sec. 484.60(a). Specifically, in addition to the longstanding plan
of care content requirements previously listed at Sec. 484.18(a), a
home health plan of care must also include the following:
A description of the patient's risk for emergency
department visits and hospital readmission, and all necessary
interventions to address the underlying risk factors; and
Information related to any advance directives.
The new content requirements for the plan of care at Sec.
484.60(a) became effective January 13, 2018 (82 FR 31729) and the
Interpretive Guidelines to accompany the new CoPs were released on
August 31, 2018. Since implementation of the new home health CoP plan
of care requirements, we stated in subregulatory guidance in the
Medicare Benefit Policy Manual, chapter 7,\27\ that the plan of care
must include the identification of the responsible discipline(s)
providing home health services, and the frequency and duration of all
visits, as well as those items required by the CoPs that establish the
need for such services (Sec. 484.60(a)(2)(iii) and (iv)). Although not
legally binding, the revised guidance in the Medicare Benefit Policy
Manual is our preferred policy; therefore, in the CY 2020 HH PPS
proposed rule, we stated that the current requirements at Sec.
409.43(a) may be overly prescriptive and may interfere with timely
payment for otherwise eligible episodes of care. To mitigate these
potential issues, we proposed to change the regulations text at Sec.
409.43(a). Specifically, we proposed to change the regulations text to
state that for HHA services to be covered, the individualized plan of
care must specify the services necessary to meet the
[[Page 60551]]
patient-specific needs identified in the comprehensive assessment. In
addition, the plan of care must include 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) that establish the
need for such services. All care provided must be in accordance with
the plan of care. While these newly-added plan of care items at Sec.
484.60(a) remain a CoP requirement, we believe that violations for an
HHA inadvertently omitting required items are best addressed through
the survey process, rather than through claims denials for otherwise
eligible periods of care.
---------------------------------------------------------------------------
\27\ Medicare Benefit Policy Manual, Chapter 7--Home Health
Services https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf.
---------------------------------------------------------------------------
We solicited comments on the proposal to change to the regulations
text at Sec. 409.43 to state that the home health plan of care must
include those items listed in Sec. 484.60(a) that establish the need
for such services.
The following is a summary of the comments received, primarily from
HHAs, on the proposed changes to the home health plan of care
regulations.
Comment: Commenters overwhelmingly supported the proposal without
modifications. In addition, commenters agreed that the individualized
plan of care must specify services necessary to meet patient-specific
needs, which would be documented in the comprehensive assessment.
Commenters also agreed and supported CMS using the survey process to
address violations of required missing information or items.
Response: We thank commenters for their support of this proposal.
We agree that this may help mitigate any claims denials resulting from
these two items missing from the plan of care and we believe that
violations for missing required items are best addressed through the
survey process, rather than through claims denials for otherwise
eligible periods of care.
Final Decision: We are finalizing to change the regulations text at
Sec. 409.43(a) to state that for HHA services to be covered, the
individualized plan of care must specify the services necessary to meet
the patient-specific needs identified in the comprehensive assessment.
In addition, the plan of care must include 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) that establish the
need for such services. All care provided must be in accordance with
the plan of care.
IV. Home Health Value-Based Purchasing (HHVBP) Model
A. Background
As authorized by section 1115A of the Act and finalized in the CY
2016 HH PPS final rule (80 FR 68624) and in the regulations at 42 CFR
part 484, subpart F, we began testing the HHVBP Model on January 1,
2016. The HHVBP Model has an overall purpose of improving the quality
and delivery of home health care services to Medicare beneficiaries.
The specific goals of the Model are to: (1) Provide incentives for
better quality care with greater efficiency; (2) study new potential
quality and efficiency measures for appropriateness in the home health
setting; and (3) enhance the current public reporting process.
Using the randomized selection methodology finalized in the CY 2016
HH PPS final rule, we selected nine states for inclusion in the HHVBP
Model, representing each geographic area across the nation. All
Medicare-certified Home Health Agencies (HHAs) providing services in
Arizona, Florida, Iowa, Maryland, Massachusetts, Nebraska, North
Carolina, Tennessee, and Washington are required to compete in the
Model. The HHVBP Model uses the waiver authority under section
1115A(d)(1) of the Act to adjust Medicare payment rates under section
1895(b) of the Act based on the competing HHAs' performance on
applicable measures. The maximum payment adjustment percentage
increases incrementally, upward or downward, over the course of the
HHVBP Model in the following manner: (1) 3 percent in CY 2018; (2) 5
percent in CY 2019; (3) 6 percent in CY 2020; (4) 7 percent in CY 2021;
and (5) 8 percent in CY 2022. Payment adjustments are based on each
HHA's Total Performance Score (TPS) in a given performance year (PY),
which is comprised of performance on: (1) A set of measures already
reported via the Outcome and Assessment Information Set (OASIS),
completed Home Health Consumer Assessment of Healthcare Providers and
Systems (HHCAHPS) surveys, and select claims data elements; and (2)
three New Measures for which points are achieved for reporting data.
In the CY 2017 HH PPS final rule (81 FR 76741 through 76752), CY
2018 HH PPS final rule (83 FR 51701 through 51706), and CY 2019 HH PPS
final rule with comment (83 FR 56527 through 56547), we finalized
changes to the HHVBP Model. Some of those changes included adding and
removing measures from the applicable measure set, revising our
methodology for calculating benchmarks and achievement thresholds at
the state level, creating an appeals process for recalculation
requests, and revising our methodologies for weighting measures and
assigning improvement points.
B. Public Reporting of Total Performance Scores and Percentile Rankings
Under the HHVBP Model
As stated previously and discussed in prior rulemaking, one of the
goals of the HHVBP Model is to enhance the current public reporting
processes for home health. In the CY 2016 HH PPS final rule, we
finalized our proposed reporting framework for the HHVBP Model,
including both the annual and quarterly reports that are made available
to competing HHAs and a separate, publicly available quality report (80
FR 68663 through 68665). We stated that such publicly available
performance reports would inform home health industry stakeholders
(consumers, physicians, hospitals) as well as all competing HHAs
delivering care to Medicare beneficiaries within selected state
boundaries on their level of quality relative to both their peers and
their own past performance, and would also provide an opportunity to
confirm that the beneficiaries referred for home health services are
being provided the best quality of care available. We further stated
that we intended to make public competing HHAs' TPSs with the intention
of encouraging providers and other stakeholders to utilize quality
ranking when selecting an HHA. As summarized in the CY 2016 final rule
(80 FR 68665), overall, commenters generally encouraged the
transparency of data pertaining to the HHVBP Model. Commenters offered
that to the extent possible, accurate comparable data would provide
HHAs the ability to improve care delivery and patient outcomes, while
better predicting and managing quality performance and payment updates.
We have continued to discuss and solicit comments on the scope of
public reporting under the HHVBP Model in subsequent rulemaking. In the
CY 2017 final rule (81 FR 76751 through 76752), we discussed the public
display of total performance scores, stating that annual publicly
available performance reports would be a means of developing greater
transparency of Medicare data on quality and aligning the competitive
forces within the market to deliver care based on value over volume. We
stated our belief that the public reporting of competing HHAs'
performance scores under the HHVBP Model would support our continued
efforts to empower consumers by providing more
[[Page 60552]]
information to help them make health care decisions, while also
encouraging providers to strive for higher levels of quality. We
explained that we have employed a variety of means (CMS Open Door
Forums, webinars, a dedicated help desk, and a web-based forum where
training and learning resources are regularly posted) to facilitate
direct communication, sharing of information and collaboration to
ensure that we maintain transparency while developing and implementing
the HHVBP Model. This same care was taken with our plans to publicly
report performance data, through collaboration with other CMS
components that use many of the same quality measures. We also noted
that section 1895(b)(3)(B)(v) of the Act requires HHAs to submit
patient-level quality of care data using the OASIS and the HHCAHPS, and
that section 1895(b)(3)(B)(v)(III) of the Act states that this quality
data is to be made available to the public. Thus, HHAs have been
required to collect OASIS data since 1999 and report HHCAHPS data since
2012.
We solicited further public comment in the CY 2019 HH PPS proposed
rule (83 FR 32438) on which information from the Annual Total
Performance Score and Payment Adjustment Report (Annual Report) should
be made publicly available. We noted that HHAs have the opportunity to
review and appeal their Annual Report as outlined in the appeals
process finalized in the CY 2017 HH PPS final rule (81 FR 76747 through
76750). Examples of the information included in the Annual Report are
the agency name, address, TPS, payment adjustment percentage,
performance information for each measure used in the Model (for
example, quality measure scores, achievement, and improvement points),
state and cohort information, and percentile ranking. We stated that
based on the public comments received, we would consider what
information, specifically from the Annual Report, we may consider
proposing for public reporting in future rulemaking.
As we summarized in the CY 2019 HH PPS final rule with comment (83
FR 56546 through 56547), several commenters expressed support for
publicly reporting information from the Annual Total Performance Score
and Payment Adjustment Report, as they believed it would better inform
consumers and allow for more meaningful and objective comparisons among
HHAs. Other commenters suggested that CMS consider providing the
percentile ranking for HHAs along with their TPS and expressed interest
in publicly reporting all information relevant to the HHVBP Model.
Several commenters expressed concern with publicly displaying HHAs'
TPSs, citing that the methodology is still evolving and pointing out
that consumers already have access to data on the quality measures in
the Model on Home Health Compare. Another commenter believed that
publicly reporting data just for states included in the HHVBP Model
could be confusing for consumers.
As we stated in the CY 2020 HH PPS proposed rule, our belief
remains that publicly reporting HHVBP data would enhance the current
home health public reporting processes as it would better inform
beneficiaries when choosing an HHA, while incentivizing HHAs to improve
quality. Although the data made public would only pertain to the final
performance year of the Model, we believe that publicly reporting HHVBP
data for Performance Year 5 would nonetheless incentivize HHAs to
improve performance. Consistent with our discussion in prior rulemaking
of the information that we are considering for public reporting under
the HHVBP Model, we proposed to publicly report on the CMS website the
following two points of data from the final CY 2020 (PY) 5 Annual
Report for each participating HHA in the Model that qualified for a
payment adjustment for CY 2020: (1) The HHA's TPS from PY 5; and (2)
the HHA's corresponding PY 5 TPS Percentile Ranking. We stated that we
were considering making these data available on the HHVBP Model page of
the CMS Innovation website (https://innovation.cms.gov/initiatives/home-health-value-based-purchasing-model). We further stated that these
data would be reported for each such competing HHA by agency name,
city, state, and by the agency's CMS Certification Number (CCN). We
expect that these data would be made public after December 1, 2021, the
date by which we intend to complete the CY 2020 Annual Report appeals
process and issuance of the final Annual Report to each HHA.
As discussed in prior rulemaking, we believe the public reporting
of such data would further enhance quality reporting under the Model by
encouraging participating HHAs to provide better quality of care
through focusing on quality improvement efforts that could potentially
improve their TPS. In addition, we believe that publicly reporting
performance data that indicates overall performance may assist
beneficiaries, physicians, discharge planners, and other referral
sources in choosing higher-performing HHAs within the nine Model states
and allow for more meaningful and objective comparisons among HHAs on
their level of quality relative to their peers.
As discussed in the proposed rule, we believe that the TPS would be
more meaningful if the corresponding TPS Percentile Ranking were
provided so consumers can more easily assess an HHA's relative
performance. We stated that we would also provide definitions for the
HHVBP TPS and the TPS Percentile Ranking methodology to ensure the
public understands the relevance of these data points and how they were
calculated.
We further stated that under our proposal, the data reported would
be limited to one year of the Model. We believe this strikes a balance
between allowing for public reporting under the Model for the reasons
discussed while heeding commenters' concerns about reporting
performance data for earlier performance years of the HHVBP Model. We
believe publicly reporting the TPS and TPS Percentile Ranking for CY
2020 would enhance quality reporting under the Model by encouraging
participating HHAs to provide better quality of care and would promote
transparency, and could enable beneficiaries to make better informed
decisions about where to receive care.
We solicited comment on our proposal to publicly report the TPS and
TPS Percentile Ranking from the final CY 2020 PY 5 Annual Report for
each HHA in the nine Model states that qualified for a payment
adjustment for CY 2020. We also solicited comment on our proposed
amendment to Sec. 484.315 to reflect this policy. Specifically, we
proposed to add new paragraph (d) to specify that CMS will report, for
Performance Year 5, the TPS and the percentile ranking of the TPS for
each competing HHA on the CMS website.
The following is a summary of public comments received and our
responses:
Comment: The majority of commenters supported our proposal to
publicly report these performance data under the HHVBP Model, citing
that the data are appropriate for public reporting and, although
limited to performance during the final year of the Model, such
information would be beneficial for members of the public in the nine
states and potentially be valuable to beneficiaries. A commenter
encouraged CMS to make additional performance data available beyond our
proposal and to provide a link on the Home Health Compare (HHC) website
alerting consumers that this supplemental information is available. One
commenter advised CMS to provide greater clarity on the TPS and TPS
Percentile Ranking, regarding how the data is measured and how it
compares
[[Page 60553]]
to the star rating data on HHC, by providing guidance to the general
public that there will likely be instances where an HHA is a 4 or 5
star agency but not as high of a performer under the HHVBP Model. The
commenter expressed concern that the different information available
through HHC and the HHVBP Model publicly reported information may
confuse the public.
Response: As discussed in the proposed rule, we anticipate making
the HHVBP Model performance data available on the HHVBP Model page
website at https://innovation.cms.gov/initiatives/home-health-value-based-purchasing-model. We will take under consideration the
commenter's suggestion for also alerting the public of the availability
of the Model performance data on the HHC website. In addition, as
discussed in the proposed rule, to accompany the data, we will also
provide definitions for the HHVBP TPS and the TPS Percentile Ranking
methodology, as well as descriptions of the scoring methodology, on the
CMS website to ensure the public understands the relevance of these
data points and how they were calculated. We will report data by state,
CCN, and agency name. As the HHVBP Model performance data is
supplemental to the star ratings, we intend to also include a reference
to the star ratings available on the CMS website.
Comment: One commenter stated that this information is already
available on the HHC website and questioned the utility of reporting
this information for only the fifth and final year of the model.
Another commenter stated that the information is not easily understood
by Medicare beneficiaries or caregivers and is not sufficiently
impactful. Furthermore, the commenter stated that the impact of HHVBP,
from a fiscal and quality perspective, is not yet fully understood,
recent changes in quality metrics for the Model are not yet fully
integrated, and more changes are likely needed before HHA-specific
results should be publicly displayed.
Response: We continue to believe that publicly reporting HHVBP
performance data would incentivize HHAs to improve quality performance
under the Model and enhance the current home health public reporting
processes to assist consumers, patients, providers, stakeholders and
referral sources in making informed choices on their home health care
services. We note that the specific information we proposed to publicly
report is not currently provided on HHC, and that the HHVBP performance
data would supplement the information provided on HHC by together
providing a more comprehensive assessment of an HHA's performance
across a range of quality measures, including the two new composite
measures included in the HHVBP Model's measure set effective
performance year 4 (CY 2019). While the publicly reported data would be
limited to the final performance year of the model, we believe
providing this data would benefit beneficiaries by encouraging
participating HHAs to further improve the quality of care they provide.
We agree that it is important to ensure the public can understand
the data we publicly report on the HHVBP Model, and as previously
discussed, will provide accompanying information with the publicly
reported data to promote public understanding. With regard to the
recent changes to the Model, in the CY 2019 HH PPS Final Rule, we
finalized changes to the quality measures and scoring methodology for
the HHVBP Model. We would only be publicly reporting data from the CY
2020 performance year, which will be the second performance year to
which these changes in the quality measures and scoring methodology
have applied. Prior to publicly reporting the CY 2020 performance data,
we will have provided participating HHAs with multiple reports on their
performance under the modified methodology. Moreover, as discussed in
the proposed rule, we expect that these data would be made public after
December 1, 2021, the date by which we intend to complete the CY 2020
Annual Report appeals process and issuance of the final Annual Report
to each HHA. Finally, we currently have a publicly available report for
PY1 on the evaluation of the HHVBP Model on the CMS Innovation Center
website and will have more information forthcoming about the impact of
the Model.
Comment: One commenter encouraged CMS to continue to develop and
share quality data. However, they also expressed concerns with public
reporting, particularly for providers who are not participating in the
HHVBP Model, but are located in markets that overlap with HHVBP states.
The commenter requested that CMS ensure that the variation of
participation by geography does not give advantages or disadvantages to
providers based purely on state line because HHAs located in a HHVBP
Model state may have more publicly available quality information than
HHAs outside of those Model states. The commenter expressed concern
that HHAs in non-participating states would not have the same quality
information publicly available as the participating HHAs, which could
be confusing to consumers and referral sources when selecting an
agency.
Response: As stated in our response to the previous commenter's
concern, the TPS and TPS Percentile Ranking would supplement the
information publicly reported through the HHC star ratings and other
public resources, which include information about both HHVBP Model
participating and non-participating HHAs and therefore can be used by
patients or providers to review quality information on HHAs in non-
HHVBP Model states. The HHVBP Model performance data would be publicly
reported only for participating HHAs in the nine states that qualified
for a payment adjustment percentage based on their Total Performance
Score in the fifth and final performance year (CY 2020) of the Model.
We believe that making these HHVBP Model performance data available on
the CMS Innovation Center's HHVBP Model web page, along with
information about what this data represents and how it was calculated,
will minimize any potential confusion.
Final Decision: For the reasons stated and after consideration of
the comments received, we are finalizing the public reporting of the
Total Performance Score and Total Performance Score Percentile Ranking
from the final CY 2020 PY 5 Annual Report for each HHA in the nine
HHVBP Model states that qualified for a payment adjustment for CY 2020.
We are also finalizing our proposed amendment to Sec. 484.315 to
reflect this policy. As discussed in the proposed rule and in this
final rule with comment period, we expect that these data will be made
available on the HHVBP Model page of the CMS Innovation Center website
after December 1, 2021, the date by which we intend to complete the CY
2020 Annual Report appeals process and issuance of the final Annual
Report to each HHA.
We received several out-of-scope comments, including requests to
expand the HHVBP Model and for more information about when we may
consider expansion. We thank the commenters for their interest and will
address any future changes through rulemaking. We also note that HHVBP
Model evaluation reports are currently publicly available on the CMS
website (https://innovation.cms.gov/initiatives/home-health-value-based-purchasing-model), which will be updated with forthcoming
reports.
[[Page 60554]]
C. Removal of Improvement in Pain Interfering With Activity Measure
(NQF #0177)
As discussed in section V.C of this final rule with comment period,
after careful consideration of the concerns raised by commenters, the
responses provided to those concerns and the discussion of alignment
across the QRPs, CMS is finalizing the removal of the Improvement in
Pain Interfering with Activity Measure (NQF #0177) from the HH QRP
beginning with the CY 2022 HH QRP under measure removal Factor 7:
Collection or public reporting of a measure leads to negative
unintended consequences other than patient harm. HHAs will no longer be
required to submit OASIS Item M1242, Frequency of Pain Interfering with
Patient's Activity or Movement for the purposes of this measure
beginning January 1, 2021. Data for this measure will be publicly
reported on HH Compare until April 2020. As we discussed in the CY 2020
HH PPS proposed rule (84 FR 34643), as HHAs would continue to be
required to submit their data for this measure through CY 2020, we do
not anticipate any impact on the collection of this data and the
inclusion of the measure in the HHVBP Model's applicable measure set
for the final performance year (CY 2020) of the Model.
V. Home Health Care Quality Reporting Program (HH QRP)
A. 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).
B. General Considerations Used for the Selection of Quality Measures
for the HH QRP
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.
C. Quality Measures Currently Adopted for the CY 2021 HH QRP
The HH QRP currently includes 19 \28\ measures for the CY 2021
program year, as outlined in Table 28.
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\28\ The HHCAHPS has five component questions that together are
used to represent one NQF-endorsed measure.
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[GRAPHIC] [TIFF OMITTED] TR08NO19.045
D. Removal of HH QRP Measures Beginning With the CY 2022 HH QRP
In line with our Meaningful Measures Initiative, in the CY 2020 HH
PPS proposed rule (84 FR 34644 through 34645), we proposed to remove
one measure from the HH QRP beginning with the CY 2022 HH QRP.
1. Removal of the Improvement in Pain Interfering With Activity Measure
(NQF #0177)
We are removing pain-associated quality measures from our quality
reporting programs in an effort to mitigate any potential unintended,
over-prescription of opioid medications inadvertently driven by these
measures. In the CY 2020 HH PPS proposed rule (84 FR 34644 and 34645),
we proposed to remove the Improvement in Pain Interfering with Activity
Measure (NQF #0177) from the HH QRP beginning with the CY 2022 HH QRP
under our measure removal Factor 7: Collection or public reporting of a
measure leads to negative unintended consequences other than patient
harm.
In the CY 2007 HH PPS final rule (71 FR 65888 through 65891), we
adopted the Improvement in Pain Interfering with Activity Measure
beginning with the CY 2007 HH QRP. The measure was NQF-endorsed (NQF
#0177) in March 2009. This risk-adjusted outcome measure reports the
percentage of HH episodes during which the patient's frequency of pain
with activity or movement improved. The measure is calculated using
OASIS Item M1242, Frequency of Pain Interfering with Patient's Activity
or Movement.\29\
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\29\ Measure specifications can be found in the Home Health
Process Measures Table on the Home Health Quality Measures website
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-Outcome-Measures-Table-OASIS-D-11-2018c.pdf.
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We evaluated the Improvement in Pain Interfering with Activity
Measure (NQF #0177) and determined that the measure could have
unintended consequences with respect to responsible use of opioids for
the management of pain. In 2018, CMS published a comprehensive roadmap,
available at https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Opioid-epidemic-roadmap.pdf, which outlined the
agency's efforts to address national issues around prescription opioid
misuse and overuse. Because the Medicare program pays for a significant
amount of prescription opioids, the roadmap was designed to promote
appropriate stewardship of these medications that can provide a medical
benefit but also carry a risk for patients,
[[Page 60556]]
including those receiving home health. One key component of this
strategy is to prevent new cases of opioid use disorder, through
education, guidance and monitoring of opioid prescriptions. When used
correctly, prescription opioids are helpful for treating pain. However,
effective non-opioid pain treatments are available to providers and CMS
is working to promote their use.
Although we are not aware of any scientific studies that support an
association between the prior or current iterations of the Improvement
in Pain Interfering with Activity Measure (NQF #0177) and opioid
prescribing practices, out of an abundance of caution and to avoid any
potential unintended consequences, we proposed to remove the
Improvement in Pain Interfering with Activity Measure (NQF #0177) from
the HH QRP beginning with the CY 2022 HH QRP under measure removal
Factor 7: Collection or public reporting of a measure leads to negative
unintended consequences other than patient harm.
We stated in the proposed rule that if we finalized this proposal,
HHAs would no longer be required to submit OASIS Item M1242, Frequency
of Pain Interfering with Patient's Activity or Movement for the
purposes of this measure beginning January 1, 2021. We stated we are
unable to remove M1242 earlier due to the timelines associated with
implementing changes to OASIS. We also stated that if we finalized this
proposal, data for this measure would be publicly reported on HH
Compare until April 2020.
We invited public comment on this proposal and received several
comments. A discussion of these comments, along with our responses
follows.
Comment: Several commenters supported our proposal to remove the
Improvement in Pain Interfering with Activity Measure (NQF #0177) from
the HH QRP as well as the associated OASIS item M1242 used to calculate
the measure. One commenter supported removing the measure but
recommended that CMS retain M1242 for purposes of risk-adjustment. A
few commenters expressed support for CMS' proposal to add new,
standardized pain assessment items to the OASIS that would enable the
agency to continue collecting data on pain.
Response: We appreciate commenters' support for our proposal to
remove the Improvement in Pain Interfering with Activity Measure (NQF
#0177) as part of the overall HHS strategy to address opioid misuse. We
note that we do not have the authority under the HH QRP to retain the
OASIS item M1242 for risk-adjustment purposes once removed from the HH
QRP. We will evaluate the SPADE Items in section V.H.3. of this final
rule with comment period for risk adjustment use in the future.
Comment: Several commenters requested that CMS develop or share its
plans to address pain management in its quality reporting programs
(QRPs) in the future after the related measures and data elements are
removed, noting that the agency should be consistent in its approach to
addressing patient pain. One commenter recommended that CMS track the
HHA's approach to appropriate teaching of non-pharmacological pain
management options as a part of the individualized care plan.
Response: In the CY 2020 HH PPS proposed rule (84 FR 34672 through
34675) we proposed to add new, standardized patient assessment data
elements on pain to the OASIS such that agencies would continue to
collect information on patient pain that could support care planning,
quality improvement, and potential quality measurement, including risk
adjustment. In section V.H.3. of this rule, we have finalized the
adoption of the three new pain data elements. We believe their
inclusion on the next version of the OASIS will underscore the priority
of managing pain. In addition, the CMS Roadmap to Address the Opioid
Epidemic includes emphasis on non-pharmacological options for managing
pain as critical in the efforts to reduce over-reliance on and misuse
of opioids. We are committed to continuing to communicate our strategy
for both promoting pain management and appropriate use of opioids.
Comment: The majority of commenters did not support the proposal to
remove the Improvement in Pain Interfering with Activity Measure (NQF
#0177). Several commenters stated that pain is an important concern for
home health patients and that information on pain was valuable to the
care team and for quality improvement. These commenters noted that pain
can be a root cause of declining health and well-being and is linked to
patient quality of life. Some commenters said that measuring pain
improvement helps assess treatment efficacy.
Other commenters noted the lack of evidence that measuring pain
level in home health is linked to increased opioid use. One commenter
additionally noted that generally home health agencies do not prescribe
opioids.
While some commenters appreciated CMS' efforts to address the
opioid epidemic, they opposed removal of this measure, expressing
concern that this removal could decrease the priority of efforts to
manage pain, including chronic pain. A few commenters noted that
greater emphasis on pain management and impact, as well as promoting
and educating providers on non-pharmacological pain management
strategies and care plans, were important to addressing opioid misuse.
Response: We appreciate the feedback given by the commenters and
acknowledge the concerns raised. We agree that pain is an important
concern for home health patients. In response to recommendations from
the President's Commission on Combatting Drug Addiction and the Opioid
Crisis, to comply with the requirements of the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for
Patients and Communities Act (Pub. L. 115-271), and to avoid any
potential unintended consequences, in the CY 2019 OPPS/ASC final rule
(83 FR 59149) we finalized to update the Hospital Consumer Assessment
of Healthcare Providers and Systems (HCAHPS) patient experience of care
survey measure by removing three recently revised pain communication
questions. We proposed the removal of the Improvement in Pain
Interfering with Activity Measure (NQF #0177) measure in the spirit of
alignment with these efforts.
Additionally, we proposed the removal of this measure to minimize
any potential overprescribing of opioids associated with incentives to
improve scoring on the measure. We have particular concern with quality
measures that assess directly or indirectly whether or not a patient's
pain has improved, as we believe such measures may more directly
incentivize over-prescribing of opioids. We have addressed this
specific issue in previous rule-making. In the FY 2017 IPPS/LTCH PPS
final rule (82 FR 38342), we similarly finalized refinements to the
HCAHPS Survey measure pain management questions, removing questions
such as ``During this hospital stay, how often was your pain well
controlled?'' and ``During this hospital stay, how often did the
hospital staff do everything they could to help you with your pain?'',
to minimize such incentives. We plan to further evaluate this issue
across all programs.
Comment: Several commenters expressed concern that removal of M1242
would leave the OASIS without any items to assess pain, noting that
pain interference not only captures pain intensity, but also the impact
of pain on function.
[[Page 60557]]
Response: Given the adoption of the new pain items, in section
V.H.3. of this rule the OASIS would continue to contain items that
assess pain and the impact on function. CMS will require HHAs to report
OASIS M1242 through December 31, 2020. CMS will begin requiring
reporting of the new pain items finalized in section V.H.3. of this
rule January 1, 2021. This timeline will ensure that there is no gap in
the assessment and reporting of pain for this population.
Final Decision: After careful consideration of the concerns raised
by commenters, the responses provided to those concerns and the
discussion of alignment across the QRPs, we are finalizing our proposal
to remove the Improvement in Pain Interfering with Activity Measure
(NQF #0177) from the HH QRP beginning with the CY 2022 HH QRP under
measure removal Factor 7: Collection or public reporting of a measure
leads to negative unintended consequences other than patient harm. HHAs
will no longer be required to submit OASIS Item M1242, Frequency of
Pain Interfering with Patient's Activity or Movement for the purposes
of this measure beginning January 1, 2021. Data for this measure will
be publicly reported on HH Compare until April 2020.
E. New and Modified HH QRP Quality Measures Beginning With the CY 2022
HH QRP
In the CY 2020 HH PPS proposed rule (84 FR 34645 through 34650), we
proposed to adopt two process measures for the HH QRP under section
1895(b)(3)(B)(v)(IV)(aa) of the Act, both of which would satisfy
section 1899B(c)(1)(E)(ii) of the Act, which requires that the quality
measures specified by the Secretary include measures with respect to
the quality measure domain titled ``Accurately communicating the
existence of and providing for the transfer of health information and
care preferences of an individual to the individual, family caregiver
of the individual, and providers of services furnishing items and
services to the individual, when the individual transitions from a
[post-acute care] PAC provider to another applicable setting, including
a different PAC provider, a hospital, a critical access hospital, or
the home of the individual.'' Given the length of this domain title,
hereafter, we will refer to this quality measure domain as ``Transfer
of Health Information.''
The two measures we proposed to adopt are: (1) Transfer of Health
Information to Provider-Post-Acute Care; and (2) Transfer of Health
Information to Patient-Post-Acute Care. Both of these proposed measures
support our Meaningful Measures priority of promoting effective
communication and coordination of care, specifically the Meaningful
Measure area of the transfer of health information and
interoperability.
In addition to the two measure proposals, we proposed to update the
specifications for the Discharge to Community-Post Acute Care (PAC) HH
QRP measure to exclude baseline nursing facility (NF) residents from
the measure.
1. Transfer of Health Information to the Provider-Post-Acute Care (PAC)
Measure
The Transfer of Health Information to the Provider-Post-Acute Care
(PAC) Measure is a process-based measure that assesses whether or not a
current reconciled medication list is given to the admitting provider
when a patient is discharged/transferred from his or her current PAC
setting.
(a) Background
In 2013, 22.3 percent of all acute hospital discharges were
discharged to PAC settings, including 11 percent who were discharged to
home under the care of a home health agency, and 9 percent who were
discharged to SNFs.\30\ The proportion of patients being discharged
from an acute care hospital to a PAC setting was greater among
beneficiaries enrolled in Medicare fee-for-service (FFS), underscoring
the importance of the measure. Among Medicare FFS patients discharged
from an acute hospital, 42 percent went directly to PAC settings. Of
that 42 percent, 20 percent were discharged to a SNF, 18 percent were
discharged to an HHA, three percent were discharged to an IRF, and one
percent were discharged to an LTCH.\31\
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\30\ Tian, W. ``An all-payer view of hospital discharge to post-
acute care,'' May 2016. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
\31\ Ibid.
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The transfer and/or exchange of health information from one
provider to another can be done verbally (for example, clinician-to-
clinician communication in-person or by telephone), paper-based (for
example, faxed or printed copies of records), and via electronic
communication (for example, through a health information exchange
network using an electronic health/medical record, and/or secure
[[Page 60558]]
messaging). Health information, such as medication information, that is
incomplete or missing increases the likelihood of a patient or resident
safety risk, and is often life-threatening.32 33 34 35 36 37
Poor communication and coordination across health care settings
contributes to patient complications, hospital readmissions, emergency
department visits, and medication errors.
38 39 40 41 42 43 44 45 46 47 48 49 Communication has been
cited as the third most frequent root cause in sentinel events, which
The Joint Commission defines \50\ as a patient safety event that
results in death, permanent harm, or severe temporary harm. Failed or
ineffective patient handoffs are estimated to play a role in 20 percent
of serious preventable adverse events.\51\ When care transitions are
enhanced through care coordination activities, such as expedited
patient information flow, these activities can reduce duplication of
care services and costs of care, resolve conflicting care plans, and
prevent medical errors.52 53 54 55 56 57
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\32\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
\33\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
\34\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
\35\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
\36\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
\37\ Boling, P.A., ``Care transitions and home health care,''
Clinical Geriatric Medicine, 2009, Vol.25(1), pp. 135-48.
\38\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of
medication information across settings--keeping it free from
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
\39\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
\40\ Jencks, S.F., Williams, M.V., & Coleman, E.A.,
``Rehospitalizations among patients in the Medicare fee-for-service
program,'' New England Journal of Medicine, 2009, Vol. 360(14), pp.
1418-1428.
\41\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at: https://www.nap.edu/read/11623/chapter/1
\42\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling approach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
\43\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., `` The
revolving door of rehospitalization from skilled nusing facilities''
Health Affairs, 2010, Vol. 29(1), pp. 57-64.
\44\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at: https://www.nap.edu/read/11623/chapter/1.
\45\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling approach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
\46\ Forster, A.J., Murff, H.J., Peterson, J. F., Gandhi, T.K.,
& Bates, D.W., ``The incidence and severity of adverse events
affecting patients after discharge from the hospital.'' Annals of
Internal Medicine, 2003,138(3), pp. 161-167.
\47\ King, B.J., Gilmore[hyphen]Bykovskyi, A.L., Roiland, R.A.,
Polnaszek, B.E., Bowers, B.J., & Kind, A.J. ``The consequences of
poor communication during transitions from hospital to skilled
nursing facility: a qualitative study,'' Journal of the American
Geriatrics Society, 2013, Vol. 61(7), 1095-1102.
\48\ Lattimer, C. (2011). When it comes to transitions in
patient care, effective communication can make all the difference.
Generations, 35(1), 69-72.
\49\ Vognar, L., & Mujahid, N. (2015). Healthcare transitions of
older adults: an overview for the general practitioner. Rhode Island
Medical Journal (2013), 98(4), 15-18.
\50\ The Joint Commission, ``Sentinel Event Policy'' available
at https://www.jointcommission.org/sentinel_event_policy_and_procedures/
\51\ The Joint Commission. ``Sentinel Event Data Root Causes by
Event Type 2004 -2015.'' 2016. Available at: https://www.jointcommission.org/assets/1/23/jconline_Mar_2_2016.pdf.
\52\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D. C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
\53\ Institute of Medicine, ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies
Press, 2007. Available at: https://www.nap.edu/read/11623/chapter/1.
\54\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C.,
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner,
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and
preventable adverse events among hospitalized children following
implementation of a resident handoff bundle,'' JAMA, 2013, Vol.
310(21), pp. 2262-2270.
\55\ Pronovost, P., M.M.E. Johns, S. Palmer, R.C. Bono, D.B.
Fridsma, A. Gettinger, J. Goldman, W. Johnson, M. Karney, C. Samitt,
R.D. Sriram, A. Zenooz, and Y.C. Wang, Editors. Procuring
Interoperability: Achieving High-Quality, Connected, and Person-
Centered Care. Washington, DC, 2018 National Academy of Medicine.
Available at: https://nam.edu/wp-content/uploads/2018/10/Procuring-Interoperability_web.pdf.
\56\ Balaban RB, Weissman JS, Samuel PA, & Woolhandler, S.,
``Redefining and redesigning hospital discharge to enhance patient
care: a randomized controlled study,'' J Gen Intern Med, 2008, Vol.
23(8), pp. 1228-33.
\57\ Siefferman, J.W., Lin, E., & Fine, J.S. (2012). Patient
safety at handoff in rehabilitation medicine. Physical Medicine and
Rehabilitation Clinics of North America, 23(2), 241-257.
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Care transitions across health care settings have been
characterized as complex, costly, and potentially hazardous, and may
increase the risk for multiple adverse outcomes.58 59 The
rising incidence of preventable adverse events, complications, and
hospital readmissions have drawn attention to the importance of the
timely transfer of health information and care preferences at the time
of transition. Failures of care coordination, including poor
communication of information, were estimated to cost the U.S. health
care system between $25 billion and $45 billion in wasteful spending in
2011.\60\ The communication of health information and patient care
preferences is critical to ensuring safe and effective transitions from
one health care setting to another.61 62
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\58\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol 29(6), pp. 932-939.
\59\ Simmons, S., Schnelle, J., Slagle, J., Sathe, N.A.,
Stevenson, D., Carlo, M., & McPheeters, M.L., ``Resident safety
practices in nursing home settings.'' Technical Brief No. 24
(Prepared by the Vanderbilt Evidence-based Practice Center under
Contract No. 290-2015-00003-I.) AHRQ Publication No. 16-EHC022-EF.
Rockville, MD: Agency for Healthcare Research and Quality. May 2016.
Available at: https://www.ncbi.nlm.nih.gov/books/NBK384624/.
\60\ Berwick, D.M. & Hackbarth, A.D. ``Eliminating Waste in US
Health Care,'' JAMA, 2012, Vol. 307(14), pp.1513-1516.
\61\ McDonald, K.M., Sundaram, V., Bravata, D.M., Lewis, R.,
Lin, N., Kraft, S.A. & Owens, D.K. Care Coordination. Vol. 7 of:
Shojania K.G., McDonald K.M., Wachter R.M., Owens D.K., editors.
``Closing the quality gap: A critical analysis of quality
improvement strategies.'' Technical Review 9 (Prepared by the
Stanford University-UCSF Evidence-based Practice Center under
contract 290-02-0017). AHRQ Publication No. 04(07)-0051-7.
Rockville, MD: Agency for Healthcare Research and Quality. June
2006. Available at: https://www.ncbi.nlm.nih.gov/books/NBK44015/.
\62\ Lattimer, C., ``When it comes to transitions in patient
care, effective communication can make all the difference,''
Generations, 2011, Vol. 35(1), pp. 69-72.
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Patients in PAC settings often have complicated medication regimens
and require efficient and effective communication and coordination of
care between settings, including detailed transfer of medication
information.63 64 65 Patients in PAC
[[Page 60559]]
settings may be vulnerable to adverse health outcomes due to
insufficient medication information on the part of their health care
providers, and the higher likelihood for multiple comorbid chronic
conditions, polypharmacy, and complicated transitions between care
settings.66 67 Preventable adverse drug events (ADEs) may
occur after hospital discharge in a variety of settings including
PAC.\68\ For older patients discharged from the hospital, 80 percent of
the medication errors occurring during patient handoffs relate to
miscommunication between providers \69\ and for those transferring to
an HHA, medication errors typically relate to transmission of
inaccurate discharge medication lists.\70\ Medication errors and one-
fifth of ADEs occur during transitions between settings, including
admission to or discharge from a hospital to home or a PAC setting, or
transfer between hospitals.71 72
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\63\ Starmer A.J, Spector N.D., Srivastava R., West, D.C.,
Rosenbluth, G., Allen, A.D., Noble, E.L., & Landrigen, C.P.,
``Changes in medical errors after implementation of a handoff
program,'' N Engl J Med, 2014, Vol. 37(1), pp. 1803-1812.
\64\ Kruse, C.S. Marquez, G., Nelson, D., & Polomares, O., ``The
use of health information exchange to augment patient handoff in
long-term care: a systematic review,'' Applied Clinical Informatics,
2018, Vol. 9(4), pp. 752-771
\65\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R., ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
\66\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K.,L., & Zuckerman, I.H., ``Medication reconciliation
during the transition to and from long-term care settings: a
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
\67\ Levinson, D.R., & General, I., ``Adverse events in skilled
nursing facilities: national incidence among Medicare
beneficiaries.'' Washington, DC: U.S. Department of Health and Human
Services, Office of the Inspector General, February 2014. Available
at: https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
\68\ Battles J., Azam I., Grady M., & Reback K., ``Advances in
patient safety and medical liability,'' AHRQ Publication No. 17-
0017-EF. Rockville, MD: Agency for Healthcare Research and Quality,
August 2017. Available at: https://www.ahrq.gov/sites/default/files/publications/files/advances-complete_3.pdf.
\69\ Siefferman, J.W., Lin, E., & Fine, J.S. (2012). Patient
safety at handoff in rehabilitation medicine. Physical Medicine and
Rehabilitation Clinics of North America, 23(2), 241-257.
\70\ Hale, J., Neal, E.B., Myers, A., Wright, K.H.S., Triplett,
J., Brown, L.B., & Mixon, A.S. (2015). Medication Discrepancies and
Associated Risk Factors Identified in Home Health patients. Home
Healthcare Now, 33(9), 493-499 https://doi.org/10.1097/NHH.0000000000000290.
\71\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of
medication information across settings--keeping it free from
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
\72\ Gleason, K.M., Groszek, J.M., Sullivan, C., Rooney, D.,
Barnard, C., Noskin, G.A., ``Reconciliation of discrepancies in
medication histories and admission orders of newly hospitalized
patients,'' American Journal of Health System Pharmacy, 2004, Vol.
61(16), pp. 1689-1694.
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Patients in PAC settings often take multiple medications.
Consequently, PAC providers regularly are in the position of starting
complex new medication regimens with little knowledge of the patients
or their medication history upon admission. Medication discrepancies in
PAC are common, such as those identified in transition from hospital to
SNF \73\ and hospital to home.\74\ In one small intervention study,
approximately 90 percent of the sample of 101 patients experienced at
least one medication discrepancy in the transition from hospital to
home care.\75\
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\73\ Tjia, J., Bonner, A., Briesacher, B.A., McGee, S., Terrill,
E., Miller, K., ``Medication discrepancies upon hospital to skilled
nursing facility transitions,'' J Gen Intern Med, 2009, Vol. 24(5),
pp. 630-635.
\74\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, I.D.,
``Nurse identified hospital to home medication discrepancies:
implications for improving transitional care'', Geriatr Nurs, 2011
Vol. 31(3), pp.188-96.
\75\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, I.D.,
``Nurse identified hospital to home medication discrepancies:
implications for improving transitional care'', Geriatr Nurs, 2011
Vol. 31(3), pp.188-96.
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We would define a reconciled medication list as a list of the
current prescribed and over the counter (OTC) medications, nutritional
supplements, vitamins, and homeopathic and herbal products administered
by any route to the patient/resident at the time of discharge or
transfer. Medications may also include but are not limited to total
parenteral nutrition (TPN) and oxygen. The current medications should
include those that are: (1) Active, including those that will be
discontinued after discharge; and (2) those held during the stay and
planned to be continued/resumed after discharge. If deemed relevant to
the patient's/resident's care by the subsequent provider, medications
discontinued during the stay may be included.
A reconciled medication list often includes important information
about: (1) The patient/resident--including their name, date of birth,
information, active diagnoses, known medication and other allergies,
and known drug sensitivities and reactions; and (2) each medication,
including the name, strength, dose, route of medication administration,
frequency or timing, purpose/indication, any special instructions (for
example, crush medications), and, for any held medications, the reason
for holding the medication and when medication should resume. This
information can improve medication safety. Additional information may
be applicable and important to include in the medication list such as
the patient's/resident's weight and date taken, height and date taken,
patient's preferred language, patient's ability to self-administer
medication, when the last dose of the medication was administered by
the discharging provider, and when the final dose should be
administered (for example, end of treatment). This is not an exhaustive
list of the information that could be included in the medication list.
The suggested elements detailed in the previous definition are for
guidance purposes only and are not a requirement for the types of
information to be included in a reconciled medication list in order to
meet the measure criteria.
(b) Stakeholder and TEP Input
The Transfer of Health Information to the Provider-Post-Acute Care
(PAC) measure was developed after consideration of feedback we received
from stakeholders and four TEPs convened by our contractors. Further,
the measure was developed after evaluation of data collected during two
pilot tests we conducted in accordance with the CMS Measures Management
System Blueprint.
Our measure development contractors convened a TEP, which met on
September 27, 2016,\76\ January 27, 2017, and August 3, 2017 \77\ to
provide input on a prior version of this measure. Based on this input,
we updated the measure concept in late 2017 to include the transfer of
a specific component of health information--medication information. Our
measure development contractors reconvened a TEP on April 20, 2018 for
the purpose of obtaining expert input on the proposed measure,
including the measure's reliability, components of face validity, and
the feasibility of implementing the measure across PAC settings.
Overall, the TEP was supportive of the measure, affirming that the
measure provides an opportunity to improve the transfer of
[[Page 60560]]
medication information. A summary of the April 20, 2018 TEP proceedings
titled ``Transfer of Health Information TEP Meeting 4-June 2018'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\76\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
\77\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3/Summary-Report_Final_Feb2018.pdf.
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Our measure development contractors solicited stakeholder feedback
on the proposed measure by requesting comment on the CMS Measures
Management System Blueprint website, and accepted comments that were
submitted from March 19, 2018 to May 3, 2018. The comments received
expressed overall support for the measure. Several commenters suggested
ways to improve the measure, primarily related to what types of
information should be included at transfer. We incorporated this input
into development of the proposed measure. The summary report for the
March 19 to May 3, 2018 public comment period titled ``IMPACT--
Medication -Profile- Transferred -Public- Comment- Summary- Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(c) Pilot Testing
The measure was tested between June and August 2018 in a pilot test
that involved 24 PAC facilities/agencies, including five IRFs, six
SNFs, six LTCHs, and seven HHAs. The 24 pilot sites submitted a total
of 801 records. Analysis of agreement between coders within each
participating facility (266 qualifying pairs) indicated a 93-percent
agreement for this measure. Overall, pilot testing enabled us to verify
its reliability, components of face validity, and feasibility of being
implemented across PAC settings. Further, more than half of the sites
that participated in the pilot test stated during the debriefing
interviews that the measure could distinguish facilities or agencies
with higher quality medication information transfer from those with
lower quality medication information transfer at discharge. The pilot
test summary report is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(d) Measure Applications Partnership (MAP) Review and Related Measures
We included the measure on the 2018 Measures Under Consideration
(MUC) list for HH QRP. The NQF-convened MAP Post-Acute Care-Long Term
Care (PAC LTC) Workgroup met on December 10, 2018 and provided input on
this proposed Transfer of Health Information to the Provider-Post-Acute
Care measure. The MAP conditionally supported this measure pending NQF
endorsement, noting that the measure can promote the transfer of
important medication information. The MAP also suggested that CMS
consider a measure that can be adapted to capture bi-directional
information exchange and recommended that the medication information
transferred include important information about supplements and
opioids. More information about the MAP's recommendations for this
measure is available at: http://www.qualityforum.org/Projects/i-m/MAP/PAC-LTC_Workgroup/2019_Considerations_for_Implementing_Measures_Draft_Report.aspx.
As part of the measure development and selection process, we
identified one NQF-endorsed quality measure related to the measure,
titled Documentation of Current Medications in the Medical Record (NQF
#0419e, CMS eCQM ID: CMS68v8). This measure was adopted as one of the
recommended adult core clinical quality measures for eligible
professionals for the EHR Incentive Program beginning in 2014, and was
adopted under the Merit-based Incentive Payment System (MIPS) quality
performance category beginning in 2017. The measure is calculated based
on the percentage of visits for patients aged 18 years and older for
which the eligible professional or eligible clinician attests to
documenting a list of current medications using all resources
immediately available on the date of the encounter.
The Transfer of Health Information to the Provider-Post-Acute Care
measure addresses the transfer of medication information whereas the
NQF-endorsed measure #0419e assesses the documentation of medications,
but not the transfer of such information. Further, the measure utilizes
standardized patient assessment data elements (SPADEs), which is a
requirement for measures specified under the Transfer of Health
Information measure domain under section 1899B(c)(1)(E) of the Act,
whereas NQF #0419e does not. After review of the NQF-endorsed measure,
we determined that the Transfer of Health Information to Provider-Post-
Acute Care measure better addresses the Transfer of Health Information
measure domain, which requires that at least some of the data used to
calculate the measure be collected as standardized patient assessment
data through post-acute care assessment instruments.
Section 1899B(e)(2)(A) of the Act requires that measures specified
by the Secretary under section 1899B of the Act be endorsed by the
consensus-based entity with a contract under section 1890(a) of the
Act, which is currently the NQF. However, when a feasible and practical
measure has not been NQF endorsed for a specified area or medical topic
determined appropriate by the Secretary, section 1899B(e)(2)(B) of the
Act allows the Secretary to specify a measure that is not NQF endorsed
as long as due consideration is given to the measures that have been
endorsed or adopted by the consensus-based entity under a contract with
the Secretary. For these reasons, we believe that there is currently no
feasible NQF-endorsed measure that we could adopt under section
1899B(c)(1)(E) of the Act. However, we note that we intend to submit
the measure to the NQF for consideration of endorsement when feasible.
(e) Quality Measure Calculation
The Transfer of Health Information to the Provider-Post-Acute Care
(PAC) quality measure is calculated as the proportion of quality
episodes with a discharge/transfer assessment indicating that a current
reconciled medication list was provided to the admitting provider at
the time of discharge/transfer.
The measure denominator is the total number of quality episodes
ending in discharge/transfer to an ``admitting provider,'' which is
defined as: a short-term general hospital, intermediate care, home
under care of another organized home health service organization or a
hospice, a hospice in an institutional facility, a SNF, an LTCH, an
IRF, an inpatient psychiatric facility, or a critical access hospital
(CAH). These providers were selected for inclusion in the denominator
because they represent admitting providers captured by the current
discharge location items on the OASIS. The measure numerator is the
number of HH quality episodes (Start of Care or Resumption of Care
OASIS assessment and a Transfer or Discharge OASIS Assessment)
indicating a current reconciled medication list was provided to the
admitting provider at the time of discharge/transfer. The measure also
collects data on how information is exchanged in PAC facilities,
informing consumers and providers on how
[[Page 60561]]
information was transferred at discharge/transfer. Data pertaining to
how information is transferred by PAC providers to other providers and/
or to patients/family/caregivers will provide important information to
consumers, improving shared-decision making while selecting PAC
providers. For additional technical information about this measure,
including information about the measure calculation and the
standardized items used to calculate this measure, we referred readers
to the document titled, ``Proposed Specifications for HH QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
on the website at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. The data
source for the quality measure is the OASIS assessment instrument for
HH patients.
For more information about the data submission requirements we
proposed for this measure, we refer readers to section V.L.2. of this
final rule with comment period.
We invited public comment on this proposal and received one comment
specific to this measure. A discussion of this comment, along with our
responses, appears below. The remaining comments we received on this
measure also addressed the second transfer of health information that
we proposed to adopt. Those comments, along with our responses and our
final decision concerning both measures, can be found in section V.E.2
of this final rule with comment period.
Comment: One commenter expressed concerns that the proposed
Transfer of Health Information to the Provider-Post-Acute Care quality
measure denominator does not recognize the importance of transmitting
the medication list to providers, such as therapists, that are not
included in the proposed definition of ``admitting provider.
Response: We appreciate the suggestion to expand the Transfer of
Health Information to The Provider-Post-Acute Care measure to assess
the transfer of health information to include other providers such as
physical therapists. We recognize the importance of all provider
disciplines. Our proposed definition of ``admitting provider'' for
purposes of the proposed measure was informed through our measure
development and pilot testing process, and it focuses upon providers
that can be readily identified through the discharge location item on
the OASIS. This would not preclude the sharing of information that will
help inform providers such as therapist who may be involved in the
patients care once transferred or discharged. At this time, we believe
that the current means of provider identification will improve the
reliability and validity of the measure.
2. Transfer of Health Information to the Patient-Post-Acute Care (PAC)
Measure
The Transfer of Health Information to the Patient-Post-Acute Care
(PAC) measure is a process-based measure that assesses whether or not a
current reconciled medication list was provided to the patient, family,
and/or caregiver when the patient was discharged from a PAC setting to
a private home/apartment, a board and care home, assisted living, a
group home or transitional living.
(a) Background
In 2013, 22.3 percent of all acute hospital discharges were
discharged to PAC settings, including 11 percent who were discharged to
home under the care of a home health agency.\78\ The communication of
health information, such as a reconciled medication list, is critical
to ensuring safe and effective patient transitions from health care
settings to home and/or other community settings. Incomplete or missing
health information, such as medication information, increases the
likelihood of a risk to patient safety, often life-
threatening.79 80 81 82
83 Individuals who use PAC care services are particularly
vulnerable to adverse health outcomes due to their higher likelihood of
having multiple comorbid chronic conditions, polypharmacy, and
complicated transitions between care settings.84
85 Upon discharge to home, individuals in PAC settings may
be faced with numerous medication changes, new medication regimes, and
follow-up details.86 87 88 The
efficient and effective communication and coordination of medication
information may be critical to prevent potentially deadly adverse
events. When care coordination activities enhance care transitions,
these activities can reduce duplication of care services and costs of
care, resolve conflicting care plans, and prevent medical
errors.89 90
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\78\ Tian, W. ``An all-payer view of hospital discharge to
postacute care,'' May 2016. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
\79\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
\80\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
\81\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
\82\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
\83\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
\84\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,''
Journal of the American Geriatrics Society, 2016, Vol. 64(11),
pp. e166-e170.
\85\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K.L., & Zuckerman, I.H., ``Medication reconciliation during
the transition to and from long-term care settings: a systematic
review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-75.
\86\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
\87\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
\88\ Sheehan, O.C., Kharrazi, H., Carl, K.J., Leff, B., Wolff,
J.L., Roth, D.L., Gabbard, J., & Boyd, C. M., ``Helping older adults
improve their medication experience (HOME) by addressing medication
regimen complexity in home healthcare,'' Home Healthcare Now. 2018,
Vol. 36(1) pp. 10-19.
\89\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
\90\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C.,
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner,
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and
preventable adverse events among hospitalized children following
implementation of a resident handoff bundle,'' JAMA, 2013, Vol.
310(21), pp. 2262-2270.
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Finally, the transfer of a patient's discharge medication
information to the patient, family, and/or caregiver is a common
practice and supported by discharge planning requirements for
participation in Medicare and Medicaid programs.91 92 Most
PAC EHR systems
[[Page 60562]]
generate a discharge medication list to promote patient participation
in medication management, which has been shown to be potentially useful
for improving patient outcomes and transitional care.\93\
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\91\ CMS, ``Revision to state operations manual (SOM), Hospital
Appendix A--Interpretive Guidelines for 42 CFR 482.43, Discharge
Planning'' May 17, 2013. Available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-32.pdf.
\92\ The State Operations Manual Guidance to Surveyors for Long
Term Care Facilities (Guidance Sec. 483.21(c)(1) Rev. 11-22-17) for
discharge planning process. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
\93\ Toles, M., Colon-Emeric, C., Naylor, M.D., Asafu-Adjei, J.,
Hanson, L.C., ``Connect-home: transitional care of skilled nursing
facility patients and their caregivers,'' Am Geriatr Soc., 2017,
Vol. 65(10), pp. 2322-2328.
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(b) Stakeholder and TEP Input
The measure was developed after consideration of feedback we
received from stakeholders, and four TEPs convened by our contractors.
Further, the measure was developed after evaluation of data collected
during two pilot tests, we conducted in accordance with the CMS MMS
Blueprint.
Our measure development contractors convened a TEP which met on
September 27, 2016,\94\ January 27, 2017, and August 3, 2017 \95\ to
provide input on a prior version of this measure. Based on this input,
we updated the measure concept in late 2017 to include the transfer of
a specific component of health information--medication information. Our
measure development contractors reconvened this TEP on April 20, 2018
to seek expert input on the measure. Overall, the TEP members supported
the measure, affirming that the measure provides an opportunity to
improve the transfer of medication information. Most of the TEP members
believed that the measure could improve the transfer of medication
information to patients, families, and caregivers. Several TEP members
emphasized the importance of transferring information to patients and
their caregivers in a clear manner using plain language. A summary of
the April 20, 2018 TEP proceedings titled ``Transfer of Health
Information TEP Meeting 4--June 2018'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\94\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-ssessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-nformation-TEP_Summary_Report_Final-June-2017.pdf.
\95\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/;Transfer-of-Health-Information-TEP-Meetings-
2-3-Summary-Report_Final_Feb2018.pdf.
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Our measure development contractors solicited stakeholder feedback
on the measure by requesting comment on the CMS MMS Blueprint website,
and accepted comments that were submitted from March 19, 2018 to May 3,
2018. Several commenters noted the importance of ensuring that the
instruction provided to patients and caregivers is clear and
understandable to promote transparent access to medical record
information and meet the goals of the IMPACT Act. The summary report
for the March 19 to May 3, 2018 public comment period titled ``IMPACT-
Medication Profile Transferred Public Comment Summary Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html
(c) Pilot Testing
Between June and August 2018, we held a pilot test involving 24 PAC
facilities/agencies, including five IRFs, six SNFs, six LTCHs, and
seven HHAs. The 24 pilot sites submitted a total of 801 assessments.
Analysis of agreement between coders within each participating facility
(241 qualifying pairs) indicated 87 percent agreement for this measure.
Overall, pilot testing enabled us to verify its reliability, components
of face validity, and feasibility of being implemented the proposed
measure across PAC settings. Further, more than half of the sites that
participated in the pilot test stated, during debriefing interviews,
that the measure could distinguish facilities or agencies with higher
quality medication information transfer from those with lower quality
medication information transfer at discharge. The pilot test summary
report is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The summary report for pilot testing conducted in 2017 of a previous
version of the data element, at that time intended for benchmarking
purposes only, is available at: https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-instruments/Post-Acute-Care-Quality-
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(d) Measure Applications Partnership (MAP) Review and Related Measures
This measure was submitted to the 2018 MUC list for HH QRP. The
NQF-convened MAP PAC-LTC Workgroup met on December 10, 2018 and
provided input on the use of the proposed Transfer of Health
Information to the Patient-Post Acute-Care measure. The MAP
conditionally supported this measure pending NQF endorsement, noting
that the measure can promote the transfer of important medication
information to the patient. The MAP recommended that providers transmit
medication information to patients that is easy to understand because
health literacy can impact a person's ability to take medication as
directed. More information about the MAP's recommendations for this
measure is available at: http://www.qualityforum.org/Projects/i-m/MAP-PAC-LTC_Workgroup/2019_Considerations_for_Implementing_Measures_Draft_Report.aspx.
Section 1899B(e)(2)(A) of the Act requires that measures specified
by the Secretary under section 1899B of the Act be endorsed by the
entity with a contract under section 1890(a) of the Act, which is
currently the NQF. However, when a feasible and practical measure has
not been NQF-endorsed for a specified area or medical topic determined
appropriate by the Secretary, section 1899B(e)(2)(B) of the Act allows
the Secretary to specify a measure that is not NQF-endorsed as long as
due consideration is given to the measures that have been endorsed or
adopted by the consensus organization identified by the Secretary.
Therefore, in the absence of any NQF-endorsed measures that address the
Transfer of Health Information to the Patient-Post-Acute Care (PAC),
which requires that at least some of the data used to calculate the
measure be collected as standardized patient assessment data through
the post-acute care assessment instruments, we believe that there is
currently no feasible NQF-endorsed measure that we could adopt under
section 1899B(c)(1)(E) of the Act.
[[Page 60563]]
However, we note that we intend to submit the measure to the NQF for
consideration of endorsement when feasible.
(e) Quality Measure Calculation
The calculation of the Transfer of Health Information to Patient-
Post-Acute Care measure would be based on the proportion of quality
episodes with a discharge assessment indicating that a current
reconciled medication list was provided to the patient, family, and/or
caregiver at the time of discharge.
The measure denominator is the total number of HH quality episodes
ending in discharge to a private home/apartment without any further
services, a board and care home, assisted living, a group home or
transitional living. These health care providers and settings were
selected for inclusion in the denominator because they represent
discharge locations captured by items on the OASIS. The measure
numerator is the number of HH quality episodes with an OASIS discharge
assessment indicating a current reconciled medication list was provided
to the patient, family, and/or caregiver at the time of discharge. We
believe that data pertaining to how information is transferred by PAC
providers to other providers and/or to patients/family/caregivers will
provide important information to consumers, improving shared-decision
making while selecting PAC providers. For technical information about
this measure including information about the measure calculation, we
refer readers to the document titled ``Proposed Specifications for HH
QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
For more information about the data submission requirements we
proposed for this measure, we refer readers to section V.L.2. of this
final rule with comment period.
Commenters submitted the following comments on the two proposed
transfer of health information measures that we proposed to adopt,
beginning with the CY 2022 HH QRP. A discussion of these comments,
along with our responses, appears in this section of this final rule
with comment period.
Comment: The majority of commenters supported CMS's proposal to
adopt the Transfer of Health Information to the Provider-Post-Acute
Care quality measure and Transfer of Health to the Patient-Post-Acute
Care quality measure beginning with the CY 2022 HH QRP. Many cited the
importance of timely and accurate discharge documentation to ensure
patient safety.
Response: We appreciate commenters' support for adoption of the
Transfer of Health Information quality measures beginning with the CY
2022 QRP. We concur that timely information sharing during the care
transfer process is critical to a safe patient transfer.
Comment: Multiple commenters stated that all measures used in the
HH QRP should be endorsed by the National Quality Forum.
Response: While section 1899B(e)(2)(A) of the Act requires that any
measure specified by the Secretary be endorsed by the entity with a
contract under section 1890(a) of the Act, which is currently the
National Quality Form (NQF), when a feasible and practical measure has
not been NQF endorsed for a specified area or medical topic determined
appropriate by the Secretary, section 1899B(e)(2)(B) of the Act allows
the Secretary to specify a measure that is not NQF endorsed as long as
due consideration is given to the measures that have been endorsed or
adopted by a consensus organization identified by the Secretary. While
these two measures are not currently NQF-endorsed, we recognize that
the NQF endorsement process is an important part of measure
development. As discussed in the CY 2020 HH PPS proposed rule (84 FR
34647 through 34648), there is currently no feasible NQF-endorsed
measure that we could adopt under section 1899B(c)(1)(E) of the Act
that better addresses the Transfer of Health Information measure
domain. We plan to submit the measures for NQF endorsement
consideration as soon as feasible.
Comment: A few commenters recommended that we expedite the timeline
for beginning the collection of data on these measures. These
commenters also recommended that we refrain from making any new
revisions to the OASIS, such as adding new items for at least five
years if we finalize the proposed changes.
Response:
In the case of the Transfer of Health Information-Provider and
Transfer of Health-Patient Post-Acute Care quality measures, the
timeline outlined is intended to give providers sufficient time to
become familiar with the new measures and participate in trainings and
other stakeholder engagement initiatives prior to submitting data on
the measures. In response to the request for not making any new
revisions, we will take this recommendation under consideration.
Comment: Several commenters expressed concern about anticipated
additional burden of collecting the additional assessment data needed
to calculate these measures.
Response: We are mindful of burden that may occur from the
collection and reporting of data and measures we adopt for our quality
reporting programs. The timely and complete transfer of information
focuses on the medication list, as recommended by our TEP and through
public comment. The transfer of health information measures are each
calculated using a single OASIS item and based upon the TEP feedback
and pilot test findings, we do not believe that it will be overly
burdensome for HHAs to report these items. We also believe that these
measures will likely drive improvements in the transfer of medication
information between providers and with patients, families, and
caregivers and thus justify the additional burden being imposed.
Comment: A few commenters recommended CMS adopt fewer process
measures and more outcome measures for the HH QRP.
Response: While we agree that outcome measures are important, and
have worked to consistently adopt outcome and claims-based measures, we
also believe that process measures, are important and necessary to
promote the quality of care furnished by HHAs. The proposed transfer of
health measures in particular will ensure care is coordinated at the
time of discharge.
Comment: One commenter recommended that the data element for the
Transfer of Health Information to the Patient-Post-Acute-Care should be
clear that if a Medicare beneficiary has a family caregiver, then that
caregiver should receive the list if the beneficiary and family
caregiver consent, even if it is also provided to the patient and that
the patient, family, or caregiver should be given a chance to ask
questions about the medication list to ensure they understand it.
Response: The Transfer of Health Information to the Patient-Post-
Acute Care data element asks about the transfer of a reconciled
medication list to the patient, family and/or caregiver. We acknowledge
the importance of family and/or caregivers and encourage collaboration
between the HHA and the family or caregiver when authorized by the
patient. HHA staff routinely provide opportunities for family and/or
caregivers to identify questions.
Comment: A few commenters requested CMS to clarify what is meant by
``reconciled [medication] list'' and
[[Page 60564]]
that the contents of a reconciled medication list are left up to the
discretion of the provider.
Response: Suggested elements detailed in the definition are for
guidance purposes only and are not a requirement in order to meet the
measure criteria. Defining the completeness of the medication list is
left to the discretion of the providers and patients who are
coordinating this care.
Comment: One commenter questioned the alignment of these proposed
measures with the rule ``Revisions to Requirements for Discharge
Planning for Hospitals, Critical Access Hospitals, and Home Health
Agencies'' (CMS-3317-F) and requested CMS ensure alignment of an
electronic option to transmit this information that aligns with the
requirements in the Discharge Planning final rule.
Response: The final rule, ``Revisions to Requirements for Discharge
Planning for Hospitals, Critical Access Hospitals, and Home Health
Agencies'' (CMS-3317-F) was finalized on September 30, 2019 (84 FR
51836). In the Discharge Planning final rule, we established that
effective November 29, 2019 an HHA must establish an effective
discharge planning process for each patient when discharged to another
PAC setting and establish a standard for the contents of the discharge
summary. In addition, we established that an HHA must comply with
additional requests from the receiving facility or agency when
necessary for the treatment of the patient. We have worked closely with
our counterparts in the agency to ensure proper alignment of this
policy proposal and the requirements in our Discharge Planning final
rule. We would like to note that neither policy contains a requirement
for electronic options to transmit the medication list or Discharge
planning information electronically. CMS is committed to furthering
interoperability in post-acute care and we encourage HHAs that are
electronically capturing discharge information to exchange that
information electronically with providers who have the capacity to
accept it.
Comment: A commenter noted that an HHA may not find out information
about a transfer to an inpatient facility until after the fact and may
not know to which facility the patient has been transferred.
Response: We acknowledge that there are times when a home health
agency may not be notified timely about a transfer to an inpatient
facility. This situation would prevent the HHA from being able to
transfer the medication information to the new facility. To address
this particular concern we have approved a Not Applicable (NA) response
at the Transfer to Inpatient Facility time point.
Final Decision: After careful consideration of the public comments
we received, we are finalizing our proposal to adopt the Transfer of
Health Information to the Provider-Post-Acute Care (PAC) and Transfer
of Health Information to the Patient-Post-Acute Care (PAC) Measures
under section 1899B(c)(1)(E) of the Act beginning with the CY 2022 HH
QRP as proposed.
3. Update to the Discharge to Community (DTC)-Post Acute Care (PAC)
Home Health (HH) Quality Reporting Program (QRP) Measure
In the CY 2020 HH PPS proposed rule (84 FR 34650 through 34651), we
proposed to update the specifications for the DTC--PAC HH QRP measure
(NQF #3477) to exclude baseline nursing facility (NF) residents from
the measure. This measure exclusion aligns with the updates to measure
exclusions for the DTC-PAC measures that we finalized in the FY 2020
SNF QRP, IRF QRP, and LTHC QRP final rules. The DTC--PAC HH QRP measure
(NQF #3477) assesses successful discharge to the community from an HHA,
with successful discharge to the community including no unplanned re-
hospitalizations and no death in the 31 days following discharge. We
adopted this measure in the CY 2017 HH PPS final rule (81 FR 76765
through 76770).
The DTC-PAC HH QRP measure (NQF #3477) does not currently exclude
baseline NF residents. We have now developed a methodology to identify
and exclude baseline NF residents using the Minimum Data Set (MDS) and
have conducted additional measure testing work. To identify baseline NF
residents, we examine any historical MDS data in the 180 days preceding
the qualifying prior acute care admission and index HH episode of care
start date. Presence of only an Omnibus Budget Reconciliation Act
(OBRA) assessment (not a SNF PPS assessment) with no intervening
community discharge between the OBRA assessment and acute care
admission date flags the index HH episode of care as baseline NF
resident. We assessed the impact of the baseline NF resident exclusion
on HH patient- and agency-level discharge to community rates using CY
2016 and CY 2017 Medicare FFS claims data. Baseline NF residents
represented 0.13 percent of the measure population after all measure
exclusions were applied. The national observed patient-level discharge
to community rate was 78.05 percent when baseline NF residents were
included in the measure, increasing to 78.08 percent when they were
excluded from the measure. After excluding baseline NF residents to
align with current or proposed exclusions in other PAC settings, the
agency-level risk-standardized discharge to community rate ranged from
3.21 percent to 100 percent, with a mean of 77.39 percent and standard
deviation of 17.27 percentage points, demonstrating a performance gap
in this domain. That is, the results show that there is a wide range in
measure results, emphasizing the opportunity for providers to improve
their measure performance.
Accordingly, in the CY 2020 HH PPS proposed rule (84 FR 34650
through 34651), we proposed to exclude baseline NF residents from the
DTC-PAC HH QRP measure beginning with the CY 2021 HH QRP. We proposed
to define ``baseline NF residents'' for purposes of this measure as HH
patients who had a long-term NF stay in the 180 days preceding their
hospitalization and HH episode, with no intervening community discharge
between the NF stay and qualifying hospitalization. We are currently
using MDS assessments, which are required quarterly for NF residents,
to identify baseline NF residents. A 180-day lookback period ensures
that we will capture both quarterly OBRA assessments identifying NF
residency and any discharge assessments to determine if there was a
discharge to community from NF.
For additional technical information regarding the DTC-PAC HH QRP
measure (NQF #3477), including technical information about the proposed
exclusion, we referred readers to the document titled ``Proposed
Specifications for HH QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We invited public comment on this proposal and received several
comments. A discussion of these comments, along with our responses,
appears in this section of this final rule with comment period.
Comment: The majority of commenters supported CMS' proposal to
exclude baseline nursing home residents from the DTC-PAC HH QRP measure
(NQF #3477), and expressed appreciation for CMS' responsiveness to
stakeholder feedback.
Response: CMS appreciates commenters' support for excluding NF
[[Page 60565]]
residents from the DTC-PAC HH QRP measure (NQF #3477).
Comment: MedPAC did not support the proposed exclusion of baseline
nursing facility residents from the DTC--PAC HH QRP measure (NQF
#3477). They suggested that CMS instead expand their definition of
``return to the community'' to include baseline nursing home residents
returning to the nursing home where they live, as this represents their
home or community. MedPAC also stated that providers should be held
accountable for the quality of care they provide for as much of their
Medicare patient population as feasible.
Response: We agree with MedPAC that providers should be held
accountable for the quality of care for as much of their Medicare
population as feasible. However, we believe this exclusion is necessary
to enhance the validity of this measure. For baseline nursing facility
residents, the goal of care is successful discharge back to their
residence at the nursing facility, which is considered an unsuccessful
outcome in this measure, rather than a discharge to the community
(defined as home/self-care without HH services). The use of risk
adjustment is inappropriate when the measurable outcome of success is
not the goal of care for this population.
Community is traditionally understood as representing non-
institutional settings by policy makers, providers, and other
stakeholders. Including long-term care NF in the definition of
community would confuse this long-standing concept of community and
would misalign with CMS' definition of community in patient assessment
instruments. We conceptualized this measure using the traditional
definition of ``community'' and specified the measure as a discharge to
community measure, rather than a discharge to baseline residence
measure.
Baseline NF residents represent an inherently different patient
population with not only a significantly lower likelihood of discharge
to community settings, but also a higher likelihood of post-discharge
readmissions and death compared with PAC patients who did not live in a
NF at baseline. The inherent differences in patient characteristics and
PAC processes and goals of care for baseline NF residents and non-NF
residents are significant enough that we do not believe risk adjustment
using a NF flag would provide adequate control. While we acknowledge
that a return to nursing home for baseline NF residents represents a
return to their home, this outcome does not align with our measure
concept. Thus, we have chosen to exclude baseline NF residents from the
measure.
Comment: One commenter noted that the Discharge to Community
measure may incentivize inappropriate discharges, adding that the
community is not always the best option for some patients. This
commenter further noted that this measure could result in agencies not
accepting certain types of patients.
Response: We appreciate the importance of incentivizing holistic,
patient-specific health decisions and to that end The Discharge to
Community measure is risk adjusted based on multiple initial patient
characteristics, including diagnoses and previous hospitalizations.
This risk adjustment accounts for potentially higher risk of
readmission or death and addresses any incentives to not admit or
inappropriately discharge high-risk patients.
Final Decision: After consideration of the public comments, we are
finalizing our proposal to exclude baseline NF residents from the DTC-
PAC HH QRP measure (NQF #3477) beginning with the CY 2021 HH QRP. We
are also finalizing our proposal to define ``baseline NF residents''
for purposes of this measure as HH patients who had a long-term NF stay
in the 180 days preceding their hospitalization and HH episode, with no
intervening community discharge between the NF stay and qualifying
hospitalization.
F. HH QRP Quality Measures, Measure Concepts, and Standardized Patient
Assessment Data Elements Under Consideration for Future Years: Request
for Information
In the CY 2020 HH PPS proposed rule (84 FR 34651), we sought input
on the importance, relevance, appropriateness, and applicability of
each of the measures, standardized patient assessment data elements
(SPADEs), and measure concepts under consideration listed in the Table
29 for future years in the HH QRP.
[GRAPHIC] [TIFF OMITTED] TR08NO19.046
[[Page 60566]]
While we are not responding to comment submissions in response to
this Request for Information in the CY 2020 HH PPS final rule with
comment period, nor are we finalizing any of these measures, measure
concepts, and SPADEs under consideration for the HH QRP in this CY 2020
HH PPS final rule with comment period, we appreciate all commenter
suggestions and intend to use this input to inform our future measure
and SPADE development efforts.
Comment: A number of commenters supported the broad range of
measures and data elements suggested as future additions to the OASIS
and the HH QRP. One provider stated strong support for CMS's plans to
adopt an exchange of health information measure, stressing the need for
adoption of interoperable health information technology in PAC settings
and in this case in home health. A number of providers supported future
adoption of functional improvement outcome measures while a few
commenters stressed the value of having maintenance measures focused on
patients who are not likely to improve. Another commenter stressed the
need for avoiding unintended consequences in punishing HHAs with
patients who are expected to decline. A commenter supported the opioid
use and frequency quality measure, but stressed the need to ensure that
providers aren't penalized for appropriately prescribing medications.
Another commenter expressed concern that the adoption of an opioid use
and frequency measure may adversely affect the appropriate use of
opioids. A few providers suggested a criterion of CMS only including
measures in the HH QRP program that have already received NQF
endorsement. A few others suggested that CMS strongly pursue removing
less useful measures and data elements from the HH QRP at the time in
which new measures or data elements are considered for supplementing
the HH QRP.
With respect to future SPADE proposals, one commenter strongly
supported introduction of a caregiver status data element. A few other
commenters suggested the need to add data elements that address housing
and food security to any social determinants of health SPADEs under
consideration. One commenter stressed the need for current and future
SPADEs to more adequately account for patients with a broader range of
speech, hearing, and swallowing abilities. Finally, one commenter
suggested that CMS should not consider introducing any data element
that has not already undergone data testing since this limits the
ability of providers and the general public to provide input into
potential implementation implications of the data elements.
We appreciate the feedback submitted on these issues.
G. Standardized Patient Assessment Data Reporting Beginning With the CY
2022 HH QRP
Section 1895(b)(3)(B)(v)(IV)(bb) of the Act requires that, for CY
2019 (beginning January 1, 2019) and each subsequent year, HHAs report
standardized patient assessment data required under section 1899B(b)(1)
of the Act. Section 1899B(a)(1)(C) of the Act requires, in part, the
Secretary to modify the PAC assessment instruments in order for PAC
providers, including HHAs, to submit SPADEs under the Medicare program.
Section 1899B(b)(1)(A) of the Act requires that PAC providers must
submit SPADEs under applicable reporting provisions, (which for HHAs is
the HH QRP) with respect to the admissions and discharges of an
individual (and more frequently as the Secretary deems appropriate),
and section 1899B(b)(1)(B) defines standardized patient assessment data
as data required for at least the quality measures described in section
1899B(c)(1) of the Act and that is with respect to the following
categories: (1) Functional status, such as mobility and self-care at
admission to a PAC provider and before discharge from a PAC provider;
(2) cognitive function, such as ability to express ideas and to
understand, and mental status, such as depression and dementia; (3)
special services, treatments, and interventions, such as need for
ventilator use, dialysis, chemotherapy, central line placement, and
total parenteral nutrition; (4) medical conditions and comorbidities,
such as diabetes, congestive heart failure, and pressure ulcers; (5)
impairments, such as incontinence and an impaired ability to hear, see,
or swallow; and (6) other categories deemed necessary and appropriate
by the Secretary.
In the CY 2018 HH PPS proposed rule (82 FR 35355 through 35371), we
proposed to adopt SPADEs that would satisfy the first five categories.
While many commenters expressed support for our adoption of SPADEs,
including support for our broader standardization goal and support for
the clinical usefulness of specific proposed SPADEs in general, we did
not finalize the majority of our SPADE proposals in recognition of the
concern raised by many commenters that we were moving too fast to adopt
the SPADEs and modify our assessment instruments in light of all of the
other requirements we were also adopting under the IMPACT Act at that
time (82 FR 51737 through 51740). In addition, we noted our intention
to conduct extensive testing to ensure that the standardized patient
assessment data elements we select are reliable, valid, and appropriate
for their intended use (82 FR 51732 through 51733).
However, we did, finalize the adoption of SPADEs for two of the
categories described in section 1899B(b)(1)(B) of the Act: (1)
Functional status: Data elements currently reported by HHAs to
calculate the measure Application of Percent of Long-Term Care Hospital
Patients with an Admission and Discharge Functional Assessment and a
Care Plan That Addresses Function (NQF #2631) along with the additional
data elements in Section GG: Functional Abilities and Goals; and (2)
Medical conditions and comorbidities: The data elements used to
calculate the pressure ulcer measures, Percent of Residents or Patients
with Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678)
and the replacement measure, Changes in Skin Integrity Post-Acute Care:
Pressure Ulcer/Injury. We stated that these data elements were
important for care planning, known to be valid and reliable, and
already being reported by HHAs for the calculation of quality measures
(82 FR 51733 through 51735).
Since we issued the CY 2018 HH PPS final rule, HHAs have had an
opportunity to familiarize themselves with other new reporting
requirements that we have adopted under the IMPACT Act. We have also
conducted further testing of the proposed SPADEs, as described more
fully elsewhere in this final rule with comment period, and believe
that this testing supports their use in our PAC assessment instruments.
Therefore, we proposed to adopt many of the same SPADEs that we
previously proposed to adopt, along with other SPADEs.
In the CY 2020 HH PPS proposed rule (84 FR 34652), we proposed that
HHAs would be required to report these SPADEs beginning with the CY
2022 HH QRP. If finalized as proposed, HHAs would be required to report
this data with respect to admissions and discharges that occur between
January 1, 2021 and June 30, 2021 for the CY 2022 HH QRP. Beginning
with the CY 2023 HH QRP, we proposed that HHAs must report data with
respect to admissions and discharges that occur the successive calendar
year (for example, data from FY 2021 for the CY 2023 HH QRP and data
from FY 2022 for the CY 2024 HH QRP). For the
[[Page 60567]]
purposes of the HH QRP, we proposed that HHAs must submit SPADEs with
respect to start of care (SOC), resumption of care (ROC), and discharge
with the exception of Hearing, Vision, Race, and Ethnicity SPADEs,
which will only be collected with respect to SOC. We proposed to use
SOC for purposes of admissions because, in the HH setting, the start of
care is functionally the same as an admission.
We proposed that HHAs that submit the Hearing, Vision, Race, and
Ethnicity SPADEs with respect to SOC only will be deemed to have
submitted those SPADEs with respect to both admission and discharge,
because it is unlikely that the assessment of those SPADEs at admission
will differ from the assessment of the same SPADEs at discharge.
We considered the burden of assessment-based data collection and
aimed to minimize additional burden by evaluating whether any data that
is currently collected through one or more PAC assessment instruments
could be collected as SPADE. In selecting the proposed SPADEs, we also
took into consideration the following factors with respect to each data
element:
Overall clinical relevance.
Interoperable exchange to facilitate care coordination
during transitions in care.
Ability to capture medical complexity and risk factors
that can inform both payment and quality.
Scientific reliability and validity, general consensus
agreement for its usability.
In identifying the SPADEs proposed, we additionally drew on input from
several sources, including TEPs, public input, and the results of a
recent National Beta Test of candidate data elements conducted by our
data element (hereafter ``National Beta Test''), contractor.
The National Beta Test collected data from 3,121 patients and
residents across 143 LTCHs, SNFs, IRFs, and HHAs from November 2017 to
August 2018 to evaluate the feasibility, reliability, and validity of
candidate data elements across PAC settings. The National Beta Test
also gathered feedback on the candidate data elements from staff who
administered the test protocol in order to understand usability and
workflow of the candidate data elements. More information on the
methods, analysis plan, and results for the National Beta Test can be
found in the document titled, ``Development and Evaluation of Candidate
Standardized Patient Assessment Data Elements: Findings from the
National Beta Test (Volume 2),'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Further, to inform the proposed SPADEs, we took into account
feedback from stakeholders, as well as from technical and clinical
experts, including feedback on whether the candidate data elements
would support the factors described previously. Where relevant, we also
took into account the results of the Post-Acute Care Payment Reform
Demonstration (PAC PRD) that took place from 2006 to 2012.
We invited public comment on these proposals and received several
comments. A discussion of these comments, along with our responses,
appears in this section of this final rule with comment period.
Comment: A majority of commenters expressed support for the
adoption of the SPADEs within the categories of: Cognitive function and
mental status; special services, treatments, and interventions; medical
condition and comorbidity data; and impairments. Supporters of the
SPADE proposals highlighted the benefit of assessing the areas of
SPADEs across post-acute care settings.
Response: CMS thanks the commenters for their support of the goals
of standardization and of the proposed SPADEs. We selected the proposed
SPADEs in part because of the attributes that the commenters noted.
Comment: Some commenters suggested the need to remove duplicative
items in the OASIS and to continually assess the value of the proposed
data elements. A number of commenters expressed overall concern with
the adoption of the SPADEs due to an anticipated increase in
administrative burden for providers. Commenters recommended mitigating
this burden through introducing SPADEs over a number of years instead
of all at one time. Numerous commenters supported the following
recommendations:
1. CMS should issue a draft of the assessment tool no later than 6
months prior to the implementation date, to allow for staff training
and other necessary preparations required for agency implementation;
2. CMS should use the authority permitted by the IMPACT Act to
waive the Paperwork Reduction Act (PRA) requirements related to
modification of the assessment tools for providers subject to the
IMPACT Act and expedite CMS's ability to issue a final version of the
revised OASIS instrument in a timely manner;
3. CMS should refrain from issuing any revisions to the OASIS
instrument for at least 5 years after the 2021 implementation of the
proposed changes.
Response: Our development and selection process for the SPADEs
prioritized data elements essential to comprehensive patient care.
While the introduction of SPADEs will require some additional burden,
we maintain that there will be significant benefit associated with each
of the SPADEs to providers and patients, in that they are clinically
useful (for example, for care planning), they support patient-centered
care, and they will promote interoperability and data exchange between
providers.
We appreciate the importance of avoiding undue burden and will
continue to evaluate and consider any burden the IMPACT Act and the HH
QRP places on home health providers. In implementing the IMPACT Act
thus far, we have taken into consideration any new burden that our
requirements might place on PAC providers. We were also cognizant of
the changes that providers will need to make to implement these
additions to the OASIS. In CY 2018 HH PPS final rule (82 FR 51732), we
provided information about goals, scope, and timeline for implementing
SPADEs, as well as updated HHAs about ongoing development and testing
of data elements through other public forums. In terms of the timing of
the release of the OASIS, we plan to publish a draft of the revised
OASIS instrument in early 2020.
Comment: Some commenters suggested that CMS implement the SPADES
more slowly than proposed.
Response: We believe the current schedule is appropriate because it
aligns with the requirements of the IMPACT Act and because of our
efforts to date to prepare for the implementation of new cross-setting
SPADES. Our development and selection process for the SPADEs we are
adopting in this final rule with comment period reflect prioritized
data elements that are essential to comprehensive patient care. We
maintain that there will be significant benefit associated with each of
the SPADEs to providers and patients, in that they are clinically
useful (for example, for care planning), they support patient-centered
care, and they will promote interoperability and data exchange between
providers. We therefore believe that the proposed implementation
timeline for the SPADEs is appropriate.
[[Page 60568]]
Comment: One commenter expressed concerns about the methodology of
the National Beta Test, noting their belief that the sample was not
nationally representative.
Response: The National Beta Test was designed to generate valid and
robust national SPADE performance estimates for each of the four PAC
provider types. This required acceptable geographic diversity,
sufficient sample size, and reasonable coverage of the range of
clinical characteristics. To meet these requirements, the National Beta
Test was carefully designed so that data could be collected from a wide
range of environments (such as geographic regions, and PAC providers of
different types, sizes, and ownership), allowing for thorough
evaluation of candidate SPADE performance in all PAC settings. The
approach included a stratified random sample, to maximize
generalizability, and subsequent analyses included extensive checks on
the sampling design.
In a document that we issued in conjunction with the proposed rule
(entitled ``Proposed Specifications for HH QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html), we described key findings from
the National Beta Test related to the proposed SPADEs. We refer readers
to an initial volume of the National Beta Test report that details the
methodology of the field test (``Development and Evaluation Candidate
Standardized Patient Assessment Data Elements: Findings from the
National Beta Test (Volume 2),'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html).
Comment: Some commenters recommended that CMS leverage electronic
health record initiatives to better utilize SPADEs in home health
agencies.
Response: It is our intention to use the SPADE data to inform the
common standards and definitions to facilitate interoperable exchange
of data. We believe that a core, standardized set of data elements that
could be shared across PAC and other provider types is an important
first step to foster this interoperability between providers. We are
hopeful that by requiring the collection of standardized data, the
SPADEs may spur providers, such as home health agencies, to adopt
health information technology that eases the burden associated with
data collection and data exchange. Further, we believe that the
collection of these SPADEs reflect common clinical practice and will
improve discharge planning, as well as address errors that can occur
during transition from one setting to the next. We note the collection
of the SPADEs is one of many tasks to supporting interoperability. We
will take into consideration how best to decrease burden from data
collection including our manual processes. Additionally, we will take
into consideration ways to help incentivize providers to adopt health
information technology.
Comment: Some commenters stated support for the proposed SPADEs,
but noted reservations that the SPADEs aren't sufficient to address all
areas of assessment. One commenter described the SPADEs as an
appropriate start, but noted that the SPADEs cannot stand alone, and
must be built upon in order to be useful for risk adjustment and
quality measurement.
Response: We believe that the SPADEs as proposed represent an
important core set of information about clinical status and patient
characteristics that may be used for risk adjustment. Additionally, we
will continue to assess the use of the SPADES across our PAC settings,
including the feasibility, reliability, validity and usability of the
data elements in future risk adjustment models and quality measures. We
also welcome continued input, recommendations, and feedback from
stakeholders about ways to improve assessment and quality measurement
for PAC providers, including ways that the SPADEs could be used in the
HH QRP. Input can be shared with CMS through our PAC Quality
Initiatives email address [email protected].
H. Standardized Patient Assessment Data by Category
1. Cognitive Function and Mental Status Data
A number of underlying conditions, including dementia, stroke,
traumatic brain injury, side effects of medication, metabolic and/or
endocrine imbalances, delirium, and depression, can affect cognitive
function and mental status in PAC patient and resident populations.\96\
The assessment of cognitive function and mental status by PAC providers
is important because of the high percentage of patients and residents
with these conditions,\97\ and because these assessments provide
opportunity for improving quality of care.
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\96\ National Institute on Aging. (2014). Assessing Cognitive
Impairment in Older Patients. A Quick Guide for Primary Care
Physicians. Retrieved from: https://www.nia.nih.gov/alzheimers/publication/assessing-cognitive-impairment-older-patients.
\97\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute
Care Payment Reform Demonstration (Final report, Volume 4 of 4).
Research Triangle Park, NC: RTI International.
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Symptoms of dementia may improve with pharmacotherapy, occupational
therapy, or physical activity,98 99
100 and promising treatments for severe traumatic brain
injury are currently being tested.\101\ For older patients and
residents diagnosed with depression, treatment options to reduce
symptoms and improve quality of life include antidepressant medication
and psychotherapy,102 103 104
105 and targeted services, such as therapeutic recreation,
exercise, and restorative nursing, to increase opportunities for
psychosocial interaction.\106\
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\98\ Casey D.A., Antimisiaris D., O'Brien J. (2010). Drugs for
Alzheimer's Disease: Are They Effective? Pharmacology &
Therapeutics, 35, 208-11.
\99\ Graff M.J., Vernooij-Dassen M.J., Thijssen M., Dekker J.,
Hoefnagels W.H., Rikkert M.G.O. (2006). Community Based Occupational
Therapy for Patients with Dementia and their Care Givers: Randomised
Controlled Trial. BMJ, 333(7580): 1196.
\100\ Bherer L., Erickson K.I., Liu-Ambrose T. (2013). A Review
of the Effects of Physical Activity and Exercise on Cognitive and
Brain Functions in Older Adults. Journal of Aging Research, 657508.
\101\ Giacino J.T., Whyte J., Bagiella E., et al. (2012).
Placebo-controlled trial of amantadine for severe traumatic brain
injury. New England Journal of Medicine, 366(9), 819-826.
\102\ Alexopoulos G.S., Katz I.R., Reynolds C.F. 3rd, Carpenter
D., Docherty J.P., Ross R.W. (2001). Pharmacotherapy of depression
in older patients: a summary of the expert consensus guidelines.
Journal of Psychiatric Practice, 7(6), 361-376.
\103\ Arean P.A., Cook B.L. (2002). Psychotherapy and combined
psychotherapy/pharmacotherapy for late life depression. Biological
Psychiatry, 52(3), 293-303.
\104\ Hollon S.D., Jarrett R.B., Nierenberg A.A., Thase M.E.,
Trivedi M., Rush A.J. (2005). Psychotherapy and medication in the
treatment of adult and geriatric depression: which monotherapy or
combined treatment? Journal of Clinical Psychiatry, 66(4), 455-468.
\105\ Wagenaar D, Colenda CC, Kreft M, Sawade J, Gardiner J,
Poverejan E. (2003). Treating depression in nursing homes: practice
guidelines in the real world. J Am Osteopath Assoc. 103(10), 465-
469.
\106\ Crespy SD, Van Haitsma K, Kleban M, Hann CJ. Reducing
Depressive Symptoms in Nursing Home Residents: Evaluation of the
Pennsylvania Depression Collaborative Quality Improvement Program. J
Healthc Qual. 2016. Vol. 38, No. 6, pp. e76-e88.
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In alignment with our Meaningful Measures Initiative, accurate
assessment of cognitive function and mental status of patients and
residents in PAC is expected to make care safer by reducing harm caused
in the delivery of care;
[[Page 60569]]
promoting effective prevention and treatment of chronic disease;
strengthening person and family engagement as partners in their care;
and promoting effective communication and coordination of care. For
example, standardized assessment of cognitive function and mental
status of patients and residents in PAC will support establishing a
baseline for identifying changes in cognitive function and mental
status (for example, delirium), anticipating the patient's or
resident's ability to understand and participate in treatments during a
PAC stay, ensuring patient and resident safety (for example, risk of
falls), and identifying appropriate support needs at the time of
discharge or transfer. SPADEs will enable or support clinical decision-
making and early clinical intervention; person-centered, high quality
care through facilitating better care continuity and coordination;
better data exchange and interoperability between settings; and
longitudinal outcome analysis. Therefore, reliable SPADEs assessing
cognitive function and mental status are needed in order to initiate a
management program that can optimize a patient's or resident's
prognosis and reduce the possibility of adverse events. We describe
each of the proposed cognitive function and mental status data SPADEs
elsewhere in the final rule.
We invited comment on our proposals to collect as standardized
patient assessment data the following data with respect to cognitive
function and mental status. Commenters submitted the following comments
related to the proposed rule's discussion of the cognitive function and
mental status data elements.
Comment: A number of commenters supported the proposed use of the
BIMS and CAM, but also raised concerns with the lack of sensitivity of
these assessments for identifying mild to moderate cognitive impairment
that can impact performance of activities of daily living (ADLs).
Response: We acknowledge the limitations of the proposed SPADEs to
fully assess all areas of cognition and mental status. We strived to
balance the scope and level of detail of the data elements against the
potential burden placed on patients and providers. In our past work, we
evaluated the potential of several different cognition assessments for
use as standardized data elements in PAC settings. We ultimately
decided on the data elements in our proposal as a starting point, and
we welcome continued input, recommendations, and feedback from
stakeholders about additional data elements for standardization, which
can be shared with CMS through our PAC Quality Initiatives email
address: [email protected].
Comment: Another provider recommended supplementing the BIMS and
CAM specifically with the Development of Outpatient Therapy Payment
Alternatives (DOTPA) items for post-acute assessments. They suggest
that DOTPA items, coupled with a functional screen to detect practical
problems, need to be administered during PAC assessments.
Response: We evaluated the suitability of the DOTPA, as well as
other screening tools that targeted functional cognition, by engaging
our TEP, through ``alpha'' feasibility testing, and through soliciting
input from stakeholders. At the second TEP meeting in March 2017,
members questioned the use of data elements that rely on assessor
observation and judgment, such as DOTPA CARE tool items, and favored
other assessments of cognition that required patient interview or
patient actions. The TEP also discussed performance-based assessment of
functional cognition. These are assessments that require patients to
respond by completing a simulated task, such as ordering from a menu,
or reading medication instructions and simulating the taking of
medications, as required by the Performance Assessment of Self-Care
Skills (PASS) items. In Alpha 2 feasibility testing, which was
conducted between April and July 2017, we included a subset of items
from the DOTPA as well as the PASS. Findings of that test identified
several limitations of the DOTPA items for use as SPADEs, such as the
length of time to administer (5 to 7 minutes). In addition, interrater
reliability was highly variable among the DOTPA items, both overall and
across settings, with some items showing very low agreement (as low as
0.34) and others showing excellent agreement (as high as 0.81).
Similarly, findings of the Alpha 2 feasibility test identified several
limitations of the PASS for use as SPADEs. The PASS was relatively
time-intensive to administer (also 5 to 7 minutes), many patients in
HHAs needed assistance completing the PASS tasks, and missing data were
prevalent. Unlike the DOTPA items, interrater reliability was
consistently high overall for PASS (ranging from 0.78 to 0.92), but the
high reliability was not deemed to outweigh fundamental feasibility
concerns related to administration challenges. A summary report for the
Alpha 2 feasibility testing titled ``Development and Maintenance of
Standardized Cross Setting Patient Assessment Data for Post-Acute Care:
Summary Report of Findings from Alpha 2 Pilot Testing'' is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Alpha-2-SPADE-Pilot-Summary-Document.pdf. While we received support for the
DOTPA, PASS, and other assessments of functional cognition, commenters
also raised concerns about the reliability of the DOTPA, given that it
is based on staff evaluation, and the feasibility of the PASS, given
that the simulated medication task requires props, such as a medication
bottle with printed label and pill box, which may not be accessible in
all settings.
Based on the input from our TEP, results of alpha feasibility
testing, and input from stakeholders, we decided to propose the BIMS
for standardization at this time due to the body of research literature
supporting its feasibility and validity, its relative brevity, and its
existing use in the MDS and IRF-PAI.
a. Brief Interview for Mental Status (BIMS)
In the CY 2020 HH PPS proposed rule (84 FR 34653 through 34654), we
proposed that the data elements that comprise the BIMS meet the
definition of standardized patient assessment data with respect to
cognitive function and mental status under section 1899B(b)(1)(B)(ii)
of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35356
through 35357), dementia and cognitive impairment are associated with
long-term functional dependence and, consequently, poor quality of life
and increased health care costs and mortality.\107\ This makes
assessment of mental status and early detection of cognitive decline or
impairment critical in the PAC setting. The intensity of routine
nursing care is higher for patients and residents with cognitive
impairment than those without, and dementia is a significant variable
in predicting readmission after discharge to the community from PAC
providers.\108\
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\107\ Ag[uuml]ero-Torres, H., Fratiglioni, L., Guo, Z.,
Viitanen, M., von Strauss, E., & Winblad, B. (1998). ``Dementia is
the major cause of functional dependence in the elderly: 3-year
follow-up data from a population-based study.'' Am J of Public
Health 88(10): 1452-1456.
\108\ RTI International. Proposed Measure Specifications for
Measures Proposed in the FY 2017 IRF QRP NPRM. Research Triangle
Park, NC. 2016.
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The BIMS is a performance-based cognitive assessment screening tool
that assesses repetition, recall with and without prompting, and
temporal orientation. The data elements that
[[Page 60570]]
make up the BIMS are seven questions on the repetition of three words,
temporal orientation, and recall that result in a cognitive function
score. The BIMS was developed to be a brief objective screening tool
with a focus on learning and memory. As a brief screener, the BIMS was
not designed to diagnose dementia or cognitive impairment, but rather
to be a relatively quick and easy to score assessment that could
identify cognitively impaired patients as well as those who may be at
risk for cognitive decline and require further assessment. It is
currently in use in two of the PAC assessments: The MDS in SNFs and the
IRF-PAI used by IRFs. For more information on the BIMS, we refer
readers to the document titled, ``Proposed Specifications for HH QRP
Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The data elements that comprise the BIMS were first proposed as
SPADEs in the CY 2018 HH PPS proposed rule (82 FR 35356 through 35357).
In that proposed rule, we stated that the proposal was informed by
input we received through a call for input published on the CMS
Measures Management System Blueprint website. Input submitted from
August 12 to September 12, 2016 expressed support for use of the BIMS,
noting that it is reliable, feasible to use across settings, and will
provide useful information about patients and residents. We also stated
that those commenters had noted that the data collected through the
BIMS will provide a clearer picture of patient or resident complexity,
help with the care planning process, and be useful during care
transitions and when coordinating across providers. A summary report
for the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment Summary Report'' is available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the use of the BIMS in the HH
setting. However, a commenter suggested the BIMS should be administered
with respect to both admission and discharge, and another commenter
encouraged its use at follow-up assessments. Another commenter
expressed support for the BIMS to assess significant cognitive
impairment, but a few commenters suggested alternative cognitive
assessments as more appropriate for the HH settings, such as
assessments that would capture mild cognitive impairment and
``functional cognition.''
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the BIMS was included in the National Beta Test of candidate data
elements conducted by our data element contractor from November 2017 to
August 2018. Results of this test found the BIMS to be feasible and
reliable for use with PAC patients and residents. We stated in the
proposed rule that more information about the performance of the BIMS
in the National Beta Test could be found in the document titled,
``Proposed Specifications for HH QRP Quality Measures and SPADEs,''
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the BIMS, and
the TEP supported the assessment of patient or resident cognitive
status with respect to both admission and discharge. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Some commenters expressed concern that the BIMS, if used alone,
may not be sensitive enough to capture the range of cognitive
impairments, including mild cognitive impairment (MCI). A summary of
the public input received from the November 27, 2018 stakeholder
meeting titled ``Input on SPADEs Received After November 27, 2018
Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We understand the concerns raised by stakeholders that BIMS, if
used alone, may not be sensitive enough to capture the range of
cognitive impairments, including functional cognition and MCI, but note
that the purpose of the BIMS data elements as SPADEs is to screen for
cognitive impairment in a broad population. We also acknowledge that
further cognitive tests may be required based on a patient's condition
and will take this feedback into consideration in the development of
future standardized assessment data elements. However, taking together
the importance of assessing cognitive status, stakeholder input, and
strong test results, we proposed that the BIMS data elements meet the
definition of standardized patient assessment data with respect to
cognitive function and mental status under section 1899B(b)(1)(B)(ii)
of the Act and to adopt the BIMS as standardized patient assessment
data for use in the HH QRP.
We invited comment on our proposal to collect the BIMS as
standardized patient assessment data. We did not receive additional
comments specific to the BIMS. General comments on the category of
Cognitive Function and Mental Status are discussed in section V.H.1 of
this final rule with comment period.
Accordingly, we are finalizing our proposal to adopt the BIMS as
standardized patient assessment data beginning with the CY 2022 HH QRP
as proposed.
b. Confusion Assessment Method (CAM)
In the CY 2020 HH PPS proposed rule (84 FR 34654 through 34655), we
proposed that the data elements that comprise the Confusion Assessment
Method (CAM) meet the definition of standardized patient assessment
data with respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35357), the
CAM was developed to identify the signs and symptoms of delirium. It
results in a score that suggests whether a patient or resident should
be assigned a diagnosis of delirium. Because patients and residents
with multiple comorbidities receive services from PAC providers, it is
important to assess delirium, which is associated with a high mortality
rate and prolonged duration of stay in
[[Page 60571]]
hospitalized older adults.\109\ Assessing these signs and symptoms of
delirium is clinically relevant for care planning by PAC providers.
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\109\ Fick, D.M., Steis, M.R., Waller, J.L., & Inouye, S.K.
(2013). ``Delirium superimposed on dementia is associated with
prolonged length of stay and poor outcomes in hospitalized older
adults.'' J of Hospital Med 8(9): 500-505.
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The CAM is a patient assessment instrument that screens for overall
cognitive impairment, as well as distinguishes delirium or reversible
confusion from other types of cognitive impairment. The CAM is
currently in use in two of the PAC assessments: A four-item version of
the CAM is used in the MDS in SNFs, and a six-item version of the CAM
is used in the LTCH CARE Data Set (LCDS) in LTCHs. We proposed the
four-item version of the CAM that assesses acute change in mental
status, inattention, disorganized thinking, and altered level of
consciousness. For more information on the CAM, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The data elements that comprise the CAM were first proposed as
SPADEs in the CY 2018 HH PPS proposed rule (82 FR 35357). In that
proposed rule, we stated that the proposal was informed by input we
received through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted on the CAM from
August 12 to September 12, 2016 expressed support for use of the CAM,
noting that it would provide important information for care planning
and care coordination and, therefore, contribute to quality
improvement. We also stated that those commenters had noted the CAM is
particularly helpful in distinguishing delirium and reversible
confusion from other types of cognitive impairment. A summary report
for the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment Summary Report'' is available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule, a
commenter expressed support for the CAM to assess significant cognitive
impairment but noted that functional cognition should also be assessed.
Another commenter suggested the CAM was not suitable for the HH setting
and noted that the additional cognition items would be redundant with
existing assessment items in the OASIS data set.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the CAM was included in the National Beta Test of candidate data
elements conducted by our data element contractor from November 2017 to
August 2018. Results of this test found the CAM to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the CAM in the National Beta Test can be found
in the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, although they did not specifically discuss the CAM
data elements, the TEP supported the assessment of patient or resident
cognitive status with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing delirium, stakeholder
input, and strong test results, we proposed that the CAM data elements
meet the definition of standardized patient assessment data with
respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act and to adopt CAM as standardized patient
assessment data for use in the HH QRP.
We invited comment on our proposals to collect as standardized
patient assessment data the following data with respect to the CAM. We
did not receive any comments specific to the CAM. General comments on
the category of Cognitive Function and Mental Status are discussed in
section V.H.1 of this final rule with comment period.
Accordingly, we are finalizing our proposal to adopt the CAM data
elements as standardized patient assessment data beginning with the CY
2022 HH QRP as proposed.
c. Patient Health Questionnaire--2 to 9 (PHQ-2 to 9)
In CY 2020 HH PPS proposed rule (84 FR 34655 through 34656), we
proposed that the Patient Health Questionnaire--2 to 9 (PHQ-2 to 9)
data elements meet the definition of standardized patient assessment
data with respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act. The proposed data elements are based on
the PHQ-2 mood interview, which focuses on only the two cardinal
symptoms of depression, and the longer PHQ-9 mood interview, which
assesses presence and frequency of nine signs and symptoms of
depression. The name of the data element, the PHQ-2 to 9, refers to an
embedded skip pattern that transitions patients with a threshold level
of symptoms in the PHQ-2 to the longer assessment of the PHQ-9. The
skip pattern is described in detail in this section of this final rule
with comment period.
As described in the CY 2018 HH PPS proposed rule (82 FR 35358
through 35359), depression is a common and under-recognized mental
health condition. Assessments of depression help PAC providers better
understand the needs of their patients and residents by: Prompting
further evaluation after establishing a diagnosis of depression;
elucidating the patient's or resident's ability to participate in
therapies for conditions other than depression during their stay; and
identifying appropriate ongoing treatment and support needs at the time
of discharge.
The proposed PHQ-2 to 9 is based on the PHQ-9 mood interview. The
PHQ-2 consists of questions about only the
[[Page 60572]]
first two symptoms addressed in the PHQ-9: Depressed mood and anhedonia
(inability to feel pleasure), which are the cardinal symptoms of
depression. The PHQ-2 has performed well as both a screening tool for
identifying depression, to assess depression severity, and to monitor
patient mood over time.110 111 If a patient demonstrates
signs of depressed mood and anhedonia under the PHQ-2, then the patient
is administered the lengthier PHQ-9. This skip pattern (also referred
to as a gateway) is designed to reduce the length of the interview
assessment for patients who fail to report the cardinal symptoms of
depression. The design of the PHQ-2 to 9 reduces the burden that would
be associated with the full PHQ-9, while ensuring that patients with
indications of depressive symptoms based on the PHQ-2 receive the
longer assessment.
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\110\ Li, C., Friedman, B., Conwell, Y., & Fiscella, K. (2007).
``Validity of the Patient Health Questionnaire 2 (PHQ-2) in
identifying major depression in older people.'' J of the A
Geriatrics Society, 55(4): 596-602.
\111\ L[ouml]we, B., Kroenke, K., & Gr[auml]fe, K. (2005).
``Detecting and monitoring depression with a two-item questionnaire
(PHQ-2).'' J of Psychosomatic Research, 58(2): 163-171.
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Components of the proposed data elements are currently used in the
OASIS for HHAs (PHQ-2) and the MDS for SNFs (PHQ-9). We proposed to add
the additional data elements of the PHQ-9 to the OASIS to replace
M1730, Depression Screening. We are proposed to alter the
administration instructions for the existing and new data elements to
adopt the PHQ-2 to 9 gateway logic, meaning that administration of the
full PHQ-9 is contingent on patient responses to questions about the
cardinal symptoms of depression. For more information on the PHQ-2 to
9, we refer readers to the document titled, ``Proposed Specifications
for HH QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The PHQ-2 data elements were first proposed as SPADEs in the CY
2018 HH proposed rule (82 FR 35358 through 35359). In that proposed
rule, we stated that the proposal was informed by input we received
from the TEP convened by our data element contractor on April 6 and 7,
2016. The TEP members particularly noted that the brevity of the PHQ-2
made it feasible to administer with low burden for both assessors and
PAC patients or residents. A summary of the April 6 and 7, 2016 TEP
meeting titled ``SPADE Technical Expert Panel Summary (First
Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
That rule proposal was also informed by public input that we
received through a call for input published on the CMS Measures
Management System Blueprint website. Input was submitted from August 12
to September 12, 2016 on three versions of the PHQ depression screener:
The PHQ-2; the PHQ-9; and the PHQ-2 to 9 with the skip pattern design.
Many commenters were supportive of the standardized assessment of mood
in PAC settings, given the role that depression plays in well-being.
Several commenters expressed support for an approach that would use
PHQ-2 as a gateway to the longer PHQ-9 while still potentially reducing
burden on most patients and residents, as well as test administrators,
and ensuring the administration of the PHQ-9, which exhibits higher
specificity,\112\ for patients and residents who showed signs and
symptoms of depression on the PHQ-2. A summary report for to the
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\112\ Arroll B, Goodyear-Smith F, Crengle S, Gunn J, Kerse N,
Fishman T, et al. Validation of PHQ-2 and PHQ-9 to screen for major
depression in the primary care population. Annals of family
medicine. 2010; 8(4):348-53. doi: 10.1370/afm.1139 pmid:20644190;
PubMed Central PMCID: PMC2906530.
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In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the PHQ-2, with a few commenters
noting the limitation that the PHQ-2 is not appropriate for patients
who are physically or cognitively impaired.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the PHQ-2 to 9 data elements were included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the PHQ-2 to 9 to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
PHQ-2 to 9 in the National Beta Test can be found in the document
titled, ``Final Specifications for CY 2020 HH QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the PHQ-2 to
9. The TEP was supportive of the PHQ-2 to 9 data element set as a
screener for signs and symptoms of depression. The TEP's discussion
noted that symptoms evaluated by the full PHQ-9 (for example,
concentration, sleep, appetite) had relevance to care planning and the
overall well-being of the patient or resident, but that the gateway
approach of the PHQ-2 to 9 would be appropriate as a depression
screening assessment, as it depends on the well-validated PHQ-2 and
focuses on the cardinal symptoms of depression. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing depression, stakeholder
input, and strong test results, we proposed that the PHQ-2 to 9 data
elements meet the definition of standardized patient assessment data
with respect to
[[Page 60573]]
cognitive function and mental status under section 1899B(b)(1)(B)(ii)
of the Act and to adopt the PHQ-2 to 9 data elements as standardized
patient assessment data for use in the HH QRP.
We invited comment on our proposals to collect as standardized
patient assessment data the PHQ-2 to 9 data elements. We did not
receive comments specific to the PHQ-2 to 9 data elements. General
comments on this category of Cognitive Function and Mental Status are
discussed in section V.H.1 of this final rule with comment period.
Accordingly, we are finalizing our proposal to adopt the PHQ-2 to 9
data elements as standardized patient assessment data beginning with
the CY 2022 HH QRP as proposed.
2. Special Services, Treatments, and Interventions Data
Special services, treatments, and interventions performed in PAC
can have a major effect on an individual's health status, self-image,
and quality of life. The assessment of these special services,
treatments, and interventions in PAC is important to ensure the
continuing appropriateness of care for the patients and residents
receiving them, and to support care transitions from one PAC provider
to another, an acute care hospital, or discharge. In alignment with our
Meaningful Measures Initiative, accurate assessment of special
services, treatments, and interventions of patients and residents
served by PAC providers is expected to make care safer by reducing harm
caused in the delivery of care; promoting effective prevention and
treatment of chronic disease; strengthening person and family
engagement as partners in their care; and promoting effective
communication and coordination of care.
For example, standardized assessment of special services,
treatments, and interventions used in PAC can promote patient and
resident safety through appropriate care planning (for example,
mitigating risks such as infection or pulmonary embolism associated
with central intravenous access), and identifying life-sustaining
treatments that must be continued, such as mechanical ventilation,
dialysis, suctioning, and chemotherapy, at the time of discharge or
transfer. Standardized assessment of these data elements will enable or
support: Clinical decision-making and early clinical intervention;
person-centered, high quality care through, for example, facilitating
better care continuity and coordination; better data exchange and
interoperability between settings; and longitudinal outcome analysis.
Therefore, reliable data elements assessing special services,
treatments, and interventions are needed to initiate a management
program that can optimize a patient's or resident's prognosis and
reduce the possibility of adverse events. We provide rationale and
further support for each of the proposed data elements and in the
document titled, ``Proposed Specifications for CY 2020 HH QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
A TEP convened by our data element contractor provided input on the
data elements for special services, treatments, and interventions. In a
meeting held on January 5 and 6, 2017, the TEP found that these data
elements are appropriate for standardization because they would provide
useful clinical information to inform care planning and care
coordination. The TEP affirmed that assessment of these services and
interventions is standard clinical practice, and that the collection of
these data by means of a list and checkbox format would conform to
common workflow for PAC providers. A summary of the January 5 and 6,
2017 TEP meeting titled ``SPADE Technical Expert Panel Summary (Second
Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Comments on the category of special services, treatments, and
interventions were also submitted by stakeholders during the CY 2018 HH
PPS proposed rule (82 FR 35359 through 35369) public comment period. A
few commenters expressed support for the special services, treatments,
and interventions data elements but requested that a vendor be
contracted to support OASIS questions and answers. A commenter noted
that many of these data elements were redundant with current assessment
items and encouraged CMS to eliminate the redundancy by removing items
similar to the proposed data elements. Another commenter noted that
collecting these data elements on patients that come to the HH setting
from non-affiliated entities can be challenging. The Medicare Payment
Advisory Commission supported the addition of data elements related to
specific services, treatments, and interventions, but cautioned that
such data elements, when used for risk adjustment, may be susceptible
to inappropriate manipulation by providers and expressed that CMS may
want to consider requiring a physician signature to attest that the
reported service was reasonable and necessary. We did not propose to
require a physician signature because the existing Conditions of
Participation for HHAs already require accurate reporting of patient
assessment data, and a physician signature would be redundant. We
reported this comment in order to accurately represent the public
comments received on these proposals in the CY 2017 HH PPS proposed
rule.
We invited comment on our proposals to collect as standardized
patient assessment data the following data with respect to special
services, treatments, and interventions.
Comment: A number of commenters questioned whether data elements in
the SPADE category of Special Services, Treatments, and Interventions
were applicable to home health, due to their low prevalence and that
these data elements would place an undue burden on providers.
Response: We appreciate the commenters' concern that clinical
treatments or response categories documented by some SPADEs are
uncommon overall and/or unlikely in the HH setting. We understand that
not all SPADEs will be equally relevant to all patients and/or PAC
providers. However, we assert that even relatively rare treatments or
clinical situations, such as a patient undergoing chemotherapy while
receiving PAC services, or having a feeding tube, are important to
document, both for care planning within the setting and for transfer of
information to the next setting of care. We note that the assessment of
many of the less frequently occurring treatments and conditions is
formatted as a ``check all that apply'' list, which minimizes burden.
When treatments do not apply the assessor need only check one row for
``None of the Above.''
a. Cancer Treatment: Chemotherapy (IV, Oral, Other)
In CY 2020 HH PPS proposed rule (84 FR 34657 through 34658), we
proposed that the Chemotherapy (IV, Oral, Other) data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35359
through
[[Page 60574]]
35360), chemotherapy is a type of cancer treatment that uses drugs to
destroy cancer cells. It is sometimes used when a patient has a
malignancy (cancer), which is a serious, often life-threatening or
life-limiting condition. Both intravenous (IV) and oral chemotherapy
have serious side effects, including nausea/vomiting, extreme fatigue,
risk of infection due to a suppressed immune system, anemia, and an
increased risk of bleeding due to low platelet counts. Oral
chemotherapy can be as potent as chemotherapy given by IV but can be
significantly more convenient and less resource-intensive to
administer. Because of the toxicity of these agents, special care must
be exercised in handling and transporting chemotherapy drugs. IV
chemotherapy is administered either peripherally or more commonly given
via an indwelling central line, which raises the risk of bloodstream
infections. Given the significant burden of malignancy, the resource
intensity of administering chemotherapy, and the side effects and
potential complications of these highly-toxic medications, assessing
the receipt of chemotherapy is important in the PAC setting for care
planning and determining resource use. The need for chemotherapy
predicts resource intensity, both because of the complexity of
administering these potent, toxic drug combinations under specific
protocols, and because of what the need for chemotherapy signals about
the patient's underlying medical condition. Furthermore, the resource
intensity of IV chemotherapy is higher than for oral chemotherapy, as
the protocols for administration and the care of the central line (if
present) for IV chemotherapy require significant resources.
The Chemotherapy (IV, Oral, Other) data element consists of a
principal data element (Chemotherapy) and three response option sub-
elements: IV chemotherapy, which is generally resource-intensive; Oral
chemotherapy, which is less invasive and generally requires less
intensive administration protocols; and a third category, Other,
provided to enable the capture of other less common chemotherapeutic
approaches. This third category is potentially associated with higher
risks and is more resource intensive due to chemotherapy delivery by
other routes (for example, intraventricular or intrathecal). If the
assessor indicates that the patient is receiving chemotherapy on the
principal Chemotherapy data element, the assessor would then indicate
by which route or routes (IV, Oral, Other) the chemotherapy is
administered.
A single Chemotherapy data element that does not include the
proposed three sub-elements is currently in use in the MDS in SNFs. For
more information on the Chemotherapy (IV, Oral, Other) data element, we
refer readers to the document titled ``Proposed Specifications for HH
QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Chemotherapy data element was first proposed as a SPADE in the
CY 2018 HH PPS proposed rule (82 FR 35359 through 35360). In that
proposed rule, we stated that the proposal was informed by input we
received through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted from August 12 to
September 12, 2016 expressed support for the IV Chemotherapy data
element and suggested it be included as standardized patient assessment
data. We also stated that those commenters had noted that assessing the
use of chemotherapy services is relevant to share across the care
continuum to facilitate care coordination and care transitions and
noted the validity of the data element. Commenters also noted the
importance of capturing all types of chemotherapy, regardless of route,
and stated that collecting data only on patients and residents who
received chemotherapy by IV would limit the usefulness of this
standardized data element. A summary report for the August 12 to
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Chemotherapy data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Chemotherapy data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Chemotherapy data element to be feasible and reliable for use
with PAC patients and residents. More information about the performance
of the Chemotherapy data element in the National Beta Test can be found
in the document titled, ``Final Specifications for HH QRP Quality
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the special
services, treatments, and interventions. Although the TEP members did
not specifically discuss the Chemotherapy data element, the TEP members
supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing chemotherapy,
stakeholder input, and strong test results, we proposed that the
Chemotherapy (IV, Oral, Other) data element with a principal data
element and three sub-elements meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and
[[Page 60575]]
to adopt the Chemotherapy (IV, Oral, Other) data element as
standardized patient assessment data for use in the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Chemotherapy (IV, Oral, Other) data
element.
Comment: One commenter agreed that it is important to know if a
patient is receiving chemotherapy for cancer and the method of
administration, but also expressed concern about the lack of an
association with a patient outcome. This commenter noted that
implications of chemotherapy for patients needing speech-language
pathology services include chemotherapy-related cognitive impairment,
dysphagia, and speech- and voice-related deficits.
Response: We appreciate the commenter's concern. We agree with the
commenter that chemotherapy can create related treatment needs for
patients, such as the examples noted by the commenter. However, we
believe that it is not feasible for SPADEs to capture all of a
patient's needs related to any given treatment, and we maintain that
the Special Services, Treatments, and Interventions SPADEs provide a
common foundation of clinical assessment, which can be built on by the
individual provider or a patient's care team.
After careful consideration of the public comment we received, we
are finalizing our proposal to adopt the Chemotherapy (IV, Oral, Other)
data element as standardized patient assessment data beginning with the
CY 2022 HH QRP as proposed.
b. Cancer Treatment: Radiation
In CY 2020 HH PPS proposed rule (84 FR 34658), we proposed that the
Radiation data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35360),
radiation is a type of cancer treatment that uses high-energy
radioactivity to stop cancer by damaging cancer cell DNA, but it can
also damage normal cells. Radiation is an important therapy for
particular types of cancer, and the resource utilization is high, with
frequent radiation sessions required, often daily for a period of
several weeks. Assessing whether a patient or resident is receiving
radiation therapy is important to determine resource utilization
because PAC patients and residents will need to be transported to and
from radiation treatments, and monitored and treated for side effects
after receiving this intervention. Therefore, assessing the receipt of
radiation therapy, which would compete with other care processes given
the time burden, would be important for care planning and care
coordination by PAC providers.
The proposed data element consists of the single Radiation data
element. The Radiation data element is currently in use in the MDS for
SNFs. For more information on the Radiation data element, we refer
readers to the document titled, ``Final Specifications for HH QRP
Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Radiation data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35360). In that proposed rule, we stated that the proposal was
informed by input we received through a call for input published on the
CMS Measures Management System Blueprint website. Input submitted from
August 12 to September 12, 2016 expressed support for the Radiation
data element, noting its importance and clinical usefulness for
patients and residents in PAC settings, due to the side effects and
consequences of radiation treatment on patients and residents that need
to be considered in care planning and care transitions, the feasibility
of the item, and the potential for it to improve quality. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the special services,
treatments, and interventions data elements in general; no additional
comments were received that were specific to the Radiation data
element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Radiation data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the
Radiation data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Radiation data element in the National Beta Test can be found in the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP members did not specifically
discuss the Radiation data element, the TEP members supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing radiation, stakeholder
input, and strong test results, we proposed that the Radiation data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and to adopt the Radiation data
element as standardized patient assessment data for use in the HH QRP.
[[Page 60576]]
We invited comment on our proposal to collect as standardized
patient assessment data the Radiation data element.
Comment: One commenter expressed concern that the radiation data
element assesses whether a patient is receiving radiation for cancer
treatment, but does not identify the rationale for and outcomes
associated with radiation. The commenter noted that implications of
radiation for patients needing speech-language pathology services
include reduced head and neck range of motion due to radiation or
severe fibrosis, scar bands, and reconstructive surgery complications
and that these can impact both communication and swallowing abilities.
Response: We appreciate the commenter's concern. We agree with the
commenter that radiation can create related treatment needs for
patients, such as the examples noted by the commenter. However, we
believe that it is not feasible for SPADEs to capture all of a
patient's needs related to any given treatment, and we maintain that
the Special Services, Treatments, and Interventions SPADEs provide a
common foundation of clinical assessment, which can be built on by the
individual provider or a patient's care team.
After careful consideration of the public comment we received, we
are finalizing our proposal to adopt the Radiation data element as
standardized patient assessment data beginning with the CY 2022 HH QRP
as proposed.
c. Respiratory Treatment: Oxygen Therapy (Intermittent, Continuous,
High-Concentration Oxygen Delivery System)
In CY 2020 HH PPS proposed rule (84 FR 34658 through 34659), we
proposed that the Oxygen Therapy (Intermittent, Continuous, High-
Concentration Oxygen Delivery System) data element meets the definition
of standardized patient assessment data with respect to special
services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35360
through 35361), we proposed a data element related to oxygen therapy.
Oxygen therapy provides a patient or resident with extra oxygen when
medical conditions such as chronic obstructive pulmonary disease,
pneumonia, or severe asthma prevent the patient or resident from
getting enough oxygen from breathing. Oxygen administration is a
resource-intensive intervention, as it requires specialized equipment
such as a source of oxygen, delivery systems (for example, oxygen
concentrator, liquid oxygen containers, and high-pressure systems), the
patient interface (for example, nasal cannula or mask), and other
accessories (for example, regulators, filters, tubing). The data
element proposed here captures patient or resident use of three types
of oxygen therapy (intermittent, continuous, and high-concentration
oxygen delivery system), which reflects the intensity of care needed,
including the level of monitoring and bedside care required. Assessing
the receipt of this service is important for care planning and resource
use for PAC providers.
The proposed data element, Oxygen Therapy, consists of the
principal Oxygen Therapy data element and three sub-elements:
Continuous (whether the oxygen was delivered continuously, typically
defined as > =14 hours per day); Intermittent; or High-concentration
oxygen delivery system. Based on public comments and input from expert
advisors about the importance and clinical usefulness of documenting
the extent of oxygen use, we added a third sub-element, high-
concentration oxygen delivery system, to the sub-elements, which
previously included only intermittent and continuous. If the assessor
indicates that the patient is receiving oxygen therapy on the principal
oxygen therapy data element, the assessor would then indicate the type
of oxygen the patient receives (for example, Continuous, Intermittent,
High-concentration oxygen delivery system).
These three proposed sub-elements were developed based on similar
data elements that assess oxygen therapy, currently in use in the MDS
for SNFs (``Oxygen Therapy''), previously used in the OASIS-C2 for HHAs
(``Oxygen (intermittent or continuous)''), and a data element tested in
the PAC PRD that focused on intensive oxygen therapy (``High O2
Concentration Delivery System with FiO2 >40 percent''). For more
information on the proposed Oxygen Therapy (Continuous, Intermittent,
High-concentration oxygen delivery system) data element, we refer
readers to the document titled, ``Final Specifications for HH QRP
Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Oxygen Therapy (Continuous, Intermittent) data element was
first proposed as a standardized patient assessment data element in the
CY 2018 HH PPS proposed rule (82 FR 35360 through 35361). In that
proposed rule, we stated that the proposal was informed by input we
received on the single data element, Oxygen (inclusive of intermittent
and continuous oxygen use), through a call for input published on the
CMS Measures Management System Blueprint website. Input submitted from
August 12 to September 12, 2016 expressed the importance of the Oxygen
data element, noting feasibility of this item in PAC, and the relevance
of it to facilitating care coordination and supporting care
transitions, but suggesting that the extent of oxygen use be
documented. A summary report for the August 12 to September 12, 2016
public comment period titled ``SPADE August 2016 Public Comment Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Oxygen Therapy (Continuous,
Intermittent) data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Oxygen Therapy data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Oxygen Therapy data element to be feasible and reliable for
use with PAC patients and residents. More information about the
performance of the Oxygen Therapy data element in the National Beta
Test can be found in the document titled, ``Final Specifications for HH
QRP Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, although the TEP did not specifically discuss the
Oxygen Therapy data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Post-Acute-Care-Quality-
[[Page 60577]]
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing oxygen therapy,
stakeholder input, and strong test results, we proposed that the Oxygen
Therapy (Continuous, Intermittent, High-Concentration Oxygen Delivery
System) data element with a principal data element and three sub-
elements meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and to adopt the Oxygen
(Continuous, Intermittent, High-Concentration Oxygen Delivery System)
data element as standardized patient assessment data for use in the HH
QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Oxygen Therapy data element. We did not
receive any comments specific to the Oxygen Therapy data element.
General comments on the category of Special Services, Treatments, and
Interventions Data are discussed in section V.H.2 of this final rule
with comment period.
Accordingly, we are finalizing our proposal to adopt the Oxygen
Therapy (Intermittent, Continuous, High-Concentration Oxygen Delivery
System) data element as standardized patient assessment data beginning
with the CY 2022 HH QRP as proposed.
d. Respiratory Treatment: Suctioning (Scheduled, As Needed)
In CY 2020 HH PPS proposed rule (84 FR 34659 through 34661), we
proposed that the Suctioning (Scheduled, As needed) data element meets
the definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35361
through 35362), suctioning is a process used to clear secretions from
the airway when a person cannot clear those secretions on his or her
own. It is done by aspirating secretions through a catheter connected
to a suction source. Types of suctioning include oropharyngeal and
nasopharyngeal suctioning, nasotracheal suctioning, and suctioning
through an artificial airway such as a tracheostomy tube. Oropharyngeal
and nasopharyngeal suctioning are a key part of many patients' or
residents' care plans, both to prevent the accumulation of secretions
than can lead to aspiration pneumonias (a common condition in patients
and residents with inadequate gag reflexes), and to relieve
obstructions from mucus plugging during an acute or chronic respiratory
infection, which often lead to desaturations and increased respiratory
effort. Suctioning can be done on a scheduled basis if the patient is
judged to clinically benefit from regular interventions, or can be done
as needed when secretions become so prominent that gurgling or choking
is noted, or a sudden desaturation occurs from a mucus plug. As
suctioning is generally performed by a care provider rather than
independently, this intervention can be quite resource intensive. It
also signifies an underlying medical condition that prevents the
patient from clearing his/her secretions effectively (such as after a
stroke, or during an acute respiratory infection). Generally,
suctioning is necessary to ensure that the airway is clear of
secretions which can inhibit successful oxygenation of the individual.
The intent of suctioning is to maintain a patent airway, the loss of
which can lead to death, or complications associated with hypoxia.
The Suctioning (Scheduled, As Needed) data element consists of the
principal data element, and two sub-elements: Scheduled and As Needed.
These sub-elements capture two types of suctioning. Scheduled indicates
suctioning based on a specific frequency, such as every hour; as needed
means suctioning only when indicated. If the assessor indicates that
the patient is receiving suctioning on the principal Suctioning data
element, the assessor would then indicate the frequency (Scheduled, As
needed). The proposed data element is based on an item currently in use
in the MDS in SNFs which does not include our proposed two sub-
elements, as well as data elements tested in the PAC PRD that focused
on the frequency of suctioning required for patients and residents with
tracheostomies (``Trach Tube with Suctioning: Specify most intensive
frequency of suctioning during stay [Every _ hours]''). For more
information on the Suctioning data element, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Suctioning data element was first proposed as standardized
patient assessment data elements in the CY 2018 HH PPS proposed rule
(82 FR 35361 through 35362). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted from August 12 to September 12, 2016 expressed support
for the Suctioning data element currently used in the MDS in SNFs. The
input noted the feasibility of this item in PAC, and the relevance of
this data element to facilitating care coordination and supporting care
transitions. We also stated that those commenters had suggested that we
examine the frequency of suctioning to better understand the use of
staff time, the impact on a patient or resident's capacity to speak and
swallow, and intensity of care required. Based on these comments, we
decided to add two sub-elements (Scheduled and As needed) to the
suctioning element. The proposed Suctioning data element includes both
the principal Suctioning data element that is included on the MDS in
SNFs and two sub-elements, Scheduled and As needed. A summary report
for the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment Summary Report'' is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Suctioning data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Suctioning data element was included
[[Page 60578]]
in the National Beta Test of candidate data elements conducted by our
data element contractor from November 2017 to August 2018. Results of
this test found the Suctioning data element to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the Suctioning data element in the National Beta Test
can be found in the document titled, ``Final Specifications for HH QRP
Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Suctioning data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicited additional comments. General input on the
testing and item development process and concerns about burden were
received from stakeholders during this meeting and via email through
February 1, 2019. A summary of the public input received from the
November 27, 2018 stakeholder meeting titled ``Input on SPADEs Received
After November 27, 2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing suctioning, stakeholder
input, and strong test results, we proposed that the Suctioning
(Scheduled, As needed) data element with a principal data element and
two sub-elements meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Suctioning (Scheduled, As Needed) data element as standardized
patient assessment data for use in the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Suctioning data element.
Comment: One commenter requested that respiratory treatment--
suctioning data element also assess the frequency of suctioning, as it
can impact resource utilization and potential medication changes in the
plan of care.
Response: We appreciate the commenter's feedback that the response
options for this data element may not fully capture impacts to resource
utilization and care plans. The Suctioning data element includes sub-
elements to identify if suctioning is performed on a ``Scheduled'' or
``As Needed'' basis, but it does not directly assess the frequency of
suctioning by, for example, asking an assessor to specify how often
suctioning is scheduled. This data element differentiates between
patients who only occasionally need suctioning and patients for whom
assessment of suctioning needs is a frequent and routine part of the
care (that is, where suctioning is performed on a schedule according to
physician instructions). In our work to identify standardized patient
assessment data elements, we have strived to balance the scope and
level of detail of the data elements against the potential burden
placed on patients and providers. We further clarify that any SPADE is
intended as a minimum assessment and does not limit the ability of
providers to conduct a more comprehensive evaluation of a patient's
situation to identify the potential impacts on outcomes that the
commenter describes.
After careful consideration of the public comment we received, we
are finalizing our proposal to adopt the Suctioning (Scheduled, As
Needed) data element as standardized patient assessment data beginning
with the CY 2022 HH QRP as proposed.
e. Respiratory Treatment: Tracheostomy Care
In CY 2020 HH PPS proposed rule (84 FR 34661), we proposed that the
Tracheostomy Care data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35362), a
tracheostomy provides an air passage to help a patient or resident
breathe when the usual route for breathing is obstructed or impaired.
Generally, in all of these cases, suctioning is necessary to ensure
that the tracheostomy is clear of secretions, which can inhibit
successful oxygenation of the individual. Often, individuals with
tracheostomies are also receiving supplemental oxygenation. The
presence of a tracheostomy, albeit permanent or temporary, warrants
careful monitoring and immediate intervention if the tracheostomy
becomes occluded or if the device used becomes dislodged. While in rare
cases the presence of a tracheostomy is not associated with increased
care demands (and in some of those instances, the care of the ostomy is
performed by the patient) in general the presence of such as device is
associated with increased patient risk, and clinical care services will
necessarily include close monitoring to ensure that no life-threatening
events occur as a result of the tracheostomy. In addition, tracheostomy
care, which primarily consists of cleansing, dressing changes, and
replacement of the tracheostomy cannula is also a critical part of the
care plan. Regular cleansing is important to prevent infection such as
pneumonia and to prevent any occlusions with which there are risks for
inadequate oxygenation.
The proposed data element consists of the single Tracheostomy Care
data element. The proposed data element is currently in use in the MDS
for SNFs (``Tracheostomy care''). For more information on the
Tracheostomy Care data element, we refer readers to the document titled
``Proposed Specifications for HH QRP Quality Measures and SPADEs'',
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Tracheostomy Care data element was first proposed as a
standardized patient assessment data element in the CY 2018 HH PPS
proposed rule (82 FR 35362). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on the Tracheostomy Care data element from August 12 to
September 12, 2016 supported this data element, noting the feasibility
of this
[[Page 60579]]
item in PAC, and the relevance of this data element to facilitating
care coordination and supporting care transitions. A summary report for
the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment Summary Report'' is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Tracheostomy Care data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Tracheostomy Care data element was included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Tracheostomy Care data element to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the Tracheostomy Care data element in the National Beta
Test can be found in the document titled, ``Final Specifications for HH
QRP Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Tracheostomy Care data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing tracheostomy care,
stakeholder input, and strong test results, we proposed that the
Tracheostomy Care data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Tracheostomy Care data element as standardized patient
assessment data for use in the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Tracheostomy Care data element.
Comment: A commenter, noted the importance of tracheostomy care and
determining whether a patient is receiving tracheostomy care, as it
helps with risk adjustment and identifying increased resource
utilization. The commenter recommended that the SPADE be expanded to
ask about the size of the tracheostomy and whether the tracheostomy has
a cuff or is fenestrated.
Response: Risk adjustment determinations is an issue that we
continue to evaluate in all of our QRPs, including the HH QRP. We will
note this issue for further analysis in our future work to determine
how the SPADEs will be used. With regard to the commenter's request to
expand the Tracheostomy Care SPADE to include more detail about the
type of tracheostomy, we do not believe that this level of clinical
detail is necessary to fulfill the purposes of the SPADEs, which are to
support care coordination, care planning, and future quality measures.
We believe the broad indication that a patient is receiving
Tracheostomy Care will be sufficient for the purposes of
standardization and quality measurement.
After careful consideration of the public comment we received, we
are finalizing our proposal to adopt the Tracheostomy Care data element
as standardized patient assessment data beginning with the CY 2022 HH
QRP as proposed.
f. Respiratory Treatment: Non-Invasive Mechanical Ventilator (BiPAP,
CPAP)
In CY 2020 HH PPS proposed rule (84 FR 34661 through 34662), we
proposed that the Non-invasive Mechanical Ventilator (Bilevel Positive
Airway Pressure [BiPAP], Continuous Positive Airway Pressure [CPAP])
data element meets the definition of standardized patient assessment
data with respect to special services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35362
through 35363), BiPAP and CPAP are respiratory support devices that
prevent the airways from closing by delivering slightly pressurized air
via electronic cycling throughout the breathing cycle (BiPAP) or
through a mask continuously (CPAP). Assessment of non-invasive
mechanical ventilation is important in care planning, as both CPAP and
BiPAP are resource-intensive (although less so than invasive mechanical
ventilation) and signify underlying medical conditions about the
patient or resident who requires the use of this intervention.
Particularly when used in settings of acute illness or progressive
respiratory decline, additional staff (for example, respiratory
therapists) are required to monitor and adjust the CPAP and BiPAP
settings and the patient or resident may require more nursing
resources.
The proposed data element, Non-invasive Mechanical Ventilator
(BIPAP, CPAP), consists of the principal Non-invasive Mechanical
Ventilator data element and two response option sub-elements: BiPAP and
CPAP. If the assessor indicates that the patient is receiving non-
invasive mechanical ventilation on the principal Non-invasive
Mechanical Ventilator data element, the assessor would then indicate
which type (BIPAP, CPAP). Data elements that assess non-invasive
mechanical ventilation are currently included on LCDS for the LTCH
setting (``Non-invasive Ventilator (BIPAP, CPAP)''), and the MDS for
the SNF setting (``Non-invasive Mechanical Ventilator (BiPAP/CPAP)'').
For more information on the Non-invasive Mechanical Ventilator data
element, we refer readers to the document titled, ``Final
Specifications for HH QRP Quality Measures and SPADEs'', available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-
[[Page 60580]]
2014/IMPACT-Act-Downloads-and-Videos.html.
The Non-invasive Mechanical Ventilator data element was first
proposed as a standardized patient assessment data element in the CY
2018 HH PPS proposed rule (82 FR 35362 through 35363). In that proposed
rule, we stated that the proposal was informed by input we received
from August 12 to September 12, 2016 on a single data element, BiPAP/
CPAP, that captures equivalent clinical information but uses a
different label than the data element currently used in the MDS in SNFs
and LCDS in LTCHs, expressing support for this data element, noting the
feasibility of these items in PAC, and the relevance of this data
element for facilitating care coordination and supporting care
transitions. In addition, we also stated that some commenters supported
separating out BiPAP and CPAP as distinct sub-elements, as they are
therapies used for different types of patients and residents. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Non-invasive Mechanical
Ventilator data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Non-invasive Mechanical Ventilator data element was included
in the National Beta Test of candidate data elements conducted by our
data element contractor from November 2017 to August 2018. Results of
this test found the Non-invasive Mechanical Ventilator data element to
be feasible and reliable for use with PAC patients and residents. More
information about the performance of the Non-invasive Mechanical
Ventilator data element in the National Beta Test can be found in the
document titled, ``Final Specifications for HH QRP Quality Measures and
SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Non-invasive Mechanical Ventilator data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing non-invasive mechanical
ventilation, stakeholder input, and strong test results, we proposed
that the Non-Invasive Mechanical Ventilator (BiPAP, CPAP) data element
with a principal data element and two sub-elements meets the definition
of standardized patient assessment data with respect to special
services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Non-invasive Mechanical
Ventilator (BiPAP, CPAP) data element as standardized patient
assessment data for use in the HH QRP.
We sought comment on our proposal to collect as standardized
patient assessment data the Non-Invasive Mechanical Ventilator data
element. We did not receive any comments specific to the Non-Invasive
Mechanical Ventilator data element. General comments on the category of
Special Services, Treatments, and Interventions Data are discussed in
section V.H.2 of this final rule with comment period.
Accordingly, we are finalizing our proposal to adopt the Non-
invasive Mechanical Ventilator (BiPAP, CPAP) data element as
standardized patient assessment data beginning with the CY 2022 HH QRP
as proposed.
g. Respiratory Treatment: Invasive Mechanical Ventilator
In CY 2020 HH PPS proposed rule (84 FR 34662 through 34663),we
proposed that the Invasive Mechanical Ventilator data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35363
through 35364), invasive mechanical ventilation includes ventilators
and respirators that ventilate the patient through a tube that extends
via the oral airway into the pulmonary region or through a surgical
opening directly into the trachea. Thus, assessment of invasive
mechanical ventilation is important in care planning and risk
mitigation. Ventilation in this manner is a resource-intensive therapy
associated with life-threatening conditions without which the patient
or resident would not survive. However, ventilator use has inherent
risks requiring close monitoring. Failure to adequately care for the
patient or resident who is ventilator dependent can lead to iatrogenic
events such as death, pneumonia and sepsis. Mechanical ventilation
further signifies the complexity of the patient's underlying medical or
surgical condition. Of note, invasive mechanical ventilation is
associated with high daily and aggregate costs.\113\
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\113\ Wunsch, H., Linde-Zwirble, W. T., Angus, D. C., Hartman,
M. E., Milbrandt, E. B., & Kahn, J. M. (2010). ``The epidemiology of
mechanical ventilation use in the United States.'' Critical Care Med
38(10): 1947-1953.
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The proposed data element, Invasive Mechanical Ventilator, consists
of a single data element. Data elements that capture invasive
mechanical ventilation are currently in use in the MDS in SNFs and LCDS
in LTCHs. For more information on the Invasive Mechanical Ventilator
data element, we refer readers to the document titled, ``Final
Specifications for HH QRP Quality Measures and SPADEs, available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Invasive Mechanical Ventilator data element was first proposed
as a SPADE in the CY 2018 HH PPS
[[Page 60581]]
proposed rule (82 FR 35363 through 35364). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted on data elements that assess
invasive ventilator use and weaning status that were tested in the PAC
PRD (``Ventilator--Weaning'' and ``Ventilator--Non-Weaning'') from
August 12 to September 12, 2016 expressed support for this data
element, highlighting the importance of this information in supporting
care coordination and care transitions. We also stated that some
commenters had expressed concern about the appropriateness for
standardization given: The prevalence of ventilator weaning across PAC
providers; the timing of administration; how weaning is defined; and
how weaning status in particular relates to quality of care. These
public comments guided our decision to propose a single data element
focused on current use of invasive mechanical ventilation only, which
does not attempt to capture weaning status. A summary report for the
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Invasive Mechanical Ventilator
data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Invasive Mechanical Ventilator data element was included in
the National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Invasive Mechanical Ventilator data element to be
feasible and reliable for use with PAC patients and residents. More
information about the performance of the Invasive Mechanical Ventilator
data element in the National Beta Test can be found in the document
titled, ``Proposed Specifications for HH QRP Quality Measures and
SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Invasive Mechanical Ventilator data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing invasive mechanical
ventilation, stakeholder input, and strong test results, we proposed
that the Invasive Mechanical Ventilator data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Invasive Mechanical
Ventilator data element as standardized patient assessment data for use
in the HH QRP.
We invited comment on our proposals to collect as standardized
patient assessment data the Invasive Mechanical Ventilator data
element.
Comment: One commenter expressed concern that the invasive
mechanical ventilator element only assesses whether or not a patient is
on a mechanicalventilator. The commenter suggested CMS consider
collecting data to track functional outcomes related to progress
towards independence in communication and swallowing.
Response: In our evaluation of the suitability of data elements for
SPADEs, we examined the clinical usefulness of candidate SPADEs across
the full range of PAC providers, including HHAs. We intend to use the
SPADEs to inform care planning and comparing of assessment data for
standardized measures. We believe that assessing the use of an invasive
mechanical ventilator is a useful point of information to inform care
planning and further assessment, such as related to functional
outcomes. We wish to clarify that the proposed SPADEs are not intended
to replace comprehensive clinical evaluation and in no way preclude
providers from conducting further patient evaluation or assessments in
their settings as they believe are necessary and useful. However, we
will take into consideration functional outcomes, overall, that are
related to progress towards independence in communication and
swallowing in future modifications.
After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Invasive Mechanical Ventilator
data element as standardized patient assessment data beginning with the
CY 2022 HH QRP as proposed.
h. Intravenous (IV) Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other)
In CY 2020 HH PPS proposed rule (84 FR 34663 through 34664), we
proposed that the IV Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other) data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35364
through 35365), when we proposed a similar set of data elements related
to IV medications, IV medications are solutions of a specific
medication (for example, antibiotics, anticoagulants) administered
directly into the venous circulation via a syringe or intravenous
catheter. IV medications are administered via intravenous push, single,
intermittent, or continuous infusion through a tube placed into the
vein. Further, IV medications are more resource intensive to administer
than oral medications, and signify a higher patient complexity (and
often higher severity of illness). The clinical indications for each of
the sub-elements of the IV Medications data elements
[[Page 60582]]
(Antibiotics, Anticoagulants, Vasoactive Medications, and Other) are
very different. IV antibiotics are used for severe infections when: The
bioavailability of the oral form of the medication would be inadequate
to kill the pathogen; an oral form of the medication does not exist; or
the patient is unable to take the medication by mouth. IV
anticoagulants refer to anti-clotting medications (that is, ``blood
thinners''). IV anticoagulants are commonly used for hospitalized
patients who have deep venous thrombosis, pulmonary embolism, or
myocardial infarction, as well as those undergoing interventional
cardiac procedures. Vasoactive medications refer to the IV
administration of vasoactive drugs, including vasopressors,
vasodilators, and continuous medication for pulmonary edema, which
increase or decrease blood pressure or heart rate. The indications,
risks, and benefits of each of these classes of IV medications are
distinct, making it important to assess each separately in PAC. Knowing
whether or not patients and residents are receiving IV medication and
the type of medication provided by each PAC provider will improve
quality of care.
The IV Medications (Antibiotics, Anticoagulants, Vasoactive
Medications, and Other) data element we proposed consists of a
principal data element (IV Medications) and four response option sub-
elements: Antibiotics, Anticoagulants, Vasoactive Medications, and
Other. The Vasoactive Medications sub-element was not proposed in the
CY 2018 HH PPS proposed rule (82 FR 35364 through 35365). We added the
Vasoactive Medications sub-element to our proposal in order to
harmonize the proposed IV Mediciations element with the data currently
collected in the LCDS.
If the assessor indicates that the patient is receiving IV
medications on the principal IV Medications data element, the assessor
would then indicate which types of medications (Antibiotics,
Anticoagulants, Vasoactive Medications, Other). An IV Medications data
element is currently in use on the MDS in SNFs and there is a related
data element in OASIS that collects information on Intravenous and
Infusion Therapies. For more information on the IV Medications data
element, we refer readers to the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs, available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
An IV Medications data element was first proposed as standardized
patient assessment data elements in the CY 2018 HH PPS proposed rule
(82 FR 35364 through 35365). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on Vasoactive Medications from August 12 to September
12, 2016 supported this data element with one commenter noting the
importance of this data element in supporting care transitions. We also
stated that those commenters had criticized the need for collecting
specifically Vasoactive Medications, giving feedback that the data
element was too narrowly focused. In addition, public comment received
indicated that the clinical significance of vasoactive medications
administration alone was not high enough in PAC to merit mandated
assessment, noting that related and more useful information could be
captured in an item that assessed all IV medication use. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for IV Medications data elements.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the IV Medications data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the IV Medications data element to be feasible and reliable for
use with PAC patients and residents. More information about the
performance of the IV Medications data element in the National Beta
Test can be found in the document titled, ``Proposed Specifications for
HH QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
IV Medications data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing IV medications,
stakeholder input, and strong test results, we proposed that the IV
Medications (Antibiotics, Anticoagulation, Vasoactive Medications,
Other) data element with a principal data element and four sub-elements
meets the definition of standardized patient assessment data with
respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and to adopt the IV Medications
(Antibiotics, Anticoagulants, Vasoactive Medications, Other) data
element as standardized patient assessment data for use in the HH QRP.
We sought public comment on our proposal to collect as standardized
patient assessment data the IV Medications data element. We did not
receive any comments specific to the IV Medications (Antibiotics,
Anticoagulants, Vasoactive Medications, Other) data element. General
comments on the category of Special Services, Treatments, and
Interventions Data are
[[Page 60583]]
discussed in section V.H.2 of this final rule with comment period.
Accordingly, we are finalizing our proposal to adopt the IV
Medications (Antibiotics, Anticoagulants, Vasoactive Medications,
Other) data element as standardized patient assessment data beginning
with the CY 2022 HH QRP as proposed.
i. Transfusions
In CY 2020 HH PPS proposed rule (84 FR 34664 through 34665), we
proposed that the Transfusions data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35365),
transfusion refers to introducing blood, blood products, or other fluid
into the circulatory system of a person. Blood transfusions are based
on specific protocols, with multiple safety checks and monitoring
required during and after the infusion in case of adverse events.
Coordination with the provider's blood bank is necessary, as well as
documentation by clinical staff to ensure compliance with regulatory
requirements. In addition, the need for transfusions signifies
underlying patient complexity that is likely to require care
coordination and patient monitoring, and impacts planning for
transitions of care, as transfusions are not performed by all PAC
providers.
The proposed data element consists of a single Transfusions data
element. A data element on transfusion is currently in use in the MDS
in SNFs (``Transfusions'') and a data element tested in the PAC PRD
(``Blood Transfusions'') was found feasible for use in each of the four
PAC settings. For more information on the Transfusions data element, we
refer readers to the document titled, ``Proposed Specifications for HH
QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Transfusions data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35365).
In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the special services,
treatments, and interventions data elements in general; no additional
comments were received that were specific to the Transfusions data
element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Transfusions data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Transfusions data element to be feasible and reliable for use
with PAC patients and residents. More information about the performance
of the Transfusions data element in the National Beta Test can be found
in the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Transfusions data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing transfusions,
stakeholder input, and strong test results, we proposed that the
Transfusions data element that is currently in use in the MDS meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Transfusions data
element as standardized patient assessment data for use in the HH QRP.
We invited public comment on our proposal to collect as
standardized patient assessment data the Transfusions data element. We
did not receive any comments specific to the Transfusions data element.
General comments on the category of Special Services, Treatments, and
Interventions Data are discussed in section V.H.2 of this final rule
with comment period.
Accordingly, we are finalizing our proposal to adopt the
Transfusions data element as standardized patient assessment data
beginning with the CY 2022 HH QRP as proposed.
j. Dialysis (Hemodialysis, Peritoneal Dialysis)
In CY 2020 HH PPS proposed rule (84 FR 34655 through 34656), we
proposed that the Dialysis (Hemodialysis, Peritoneal Dialysis) data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35365
through 35366), dialysis is a treatment primarily used to provide
replacement for lost kidney function. Both forms of dialysis
(hemodialysis and peritoneal dialysis) are resource intensive, not only
during the actual dialysis process but before, during and following.
Patients and residents who need and undergo dialysis procedures are at
high risk for physiologic and hemodynamic instability from fluid shifts
and electrolyte disturbances as well as infections that can lead to
sepsis. Further, patients or residents receiving hemodialysis are often
transported to a different facility, or at a minimum, to a different
location in the same facility. Close monitoring for fluid shifts, blood
pressure abnormalities, and other adverse effects is required prior to,
during and following each dialysis session. Nursing staff typically
perform peritoneal dialysis at the bedside, and as with hemodialysis,
close monitoring is required.
The proposed data element, Dialysis (Hemodialysis, Peritoneal
Dialysis)
[[Page 60584]]
consists of the principal Dialysis data element and two response option
sub-elements: Hemodialysis and Peritoneal Dialysis. If the assessor
indicates that the patient is receiving dialysis on the principal
Dialysis data element, the assessor would then indicate which type
(Hemodialysis, Peritoneal Dialysis). The principal Dialysis data
element is currently included on the MDS in SNFs and the LCDS for LTCHs
and assesses the overall use of dialysis. As the result of public
feedback described, in this final rule with comment period, we proposed
data elements that include the principal Dialysis data element and two
sub-elements (Hemodialysis and Peritoneal Dialysis). For more
information on the Dialysis data element, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Dialysis data element was first proposed as standardized
patient assessment data elements in the CY 2018 HH PPS proposed rule
(82 FR 35365 through 35366). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on a singular Hemodialysis data element from August 12
to September 12, 2016 supported the assessment of hemodialysis and
recommended that the data element be expanded to include peritoneal
dialysis. We also stated that those commenters had supported the
singular Hemodialysis data element, noting the relevance of this
information for sharing across the care continuum to facilitate care
coordination and care transitions, the potential for this data element
to be used to improve quality, and the feasibility for use in PAC. In
addition, we received comment that the item would be useful in
improving patient and resident transitions of care. We also noted that
several commenters had stated that peritoneal dialysis should be
included in a standardized data element on dialysis and recommended
collecting information on peritoneal dialysis in addition to
hemodialysis. The rationale for including peritoneal dialysis from
commenters included the fact that patients and residents receiving
peritoneal dialysis will have different needs at post-acute discharge
compared to those receiving hemodialysis or not having any dialysis.
Based on these comments, the Hemodialysis data element was expanded to
include a principal Dialysis data element and two sub-elements,
Hemodialysis and Peritoneal Dialysis. We proposed the expanded version
of the Dialysis data element that includes two types of dialysis. A
summary report for the August 12 to September 12, 2016 public comment
period titled ``SPADE August 2016 Public Comment Summary Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the special services,
treatments, and interventions data elements in general; no additional
comments were received that were specific to the Dialysis data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Dialysis data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the
Dialysis data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Dialysis data element in the National Beta Test can be found in the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although they did not specifically discuss the
Dialysis data element, the TEP supported the assessment of the special
services, treatments, and interventions included in the National Beta
Test with respect to both admission and discharge. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing dialysis, stakeholder
input, and strong test results, we proposed that the Dialysis
(Hemodialysis, Peritoneal Dialysis) data element with a principal data
element and two sub-elements meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Dialysis (Hemodialysis, Peritoneal Dialysis) data element as
standardized patient assessment data for use in the HH QRP.
We invited public comment on our proposal to collect as
standardized patient assessment data the Dialysis data element. We did
not receive any comments specific to the Dialysis (Hemodialysis,
Peritoneal Dialysis) data element. General comments on the category of
Special Services, Treatments, and Interventions Data are discussed in
section V.H.2 of this final rule with comment period.
Accordingly, we are finalizing our proposal to adopt the Dialysis
(Hemodialysis, Peritoneal dialysis) data element as standardized
patient assessment data beginning with the CY 2022 HH QRP as proposed.
k. Intravenous (IV) Access (Peripheral IV, Midline, Central Line)
In CY 2020 HH PPS proposed rule (84 FR 34666 through 34667), we
proposed that the IV Access (Peripheral IV, Midline, Central Line) data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
[[Page 60585]]
As described in the CY 2018 HH PPS proposed rule (82 FR 35366),
patients or residents with central lines, including those peripherally
inserted or who have subcutaneous central line ``port'' access, always
require vigilant nursing care to keep patency of the lines and ensure
that such invasive lines remain free from any potentially life-
threatening events such as infection, air embolism, or bleeding from an
open lumen. Clinically complex patients and residents are likely to be
receiving medications or nutrition intravenously. The sub-elements
included in the IV Access data element distinguish between peripheral
access and different types of central access. The rationale for
distinguishing between a peripheral IV and central IV access is that
central lines confer higher risks associated with life-threatening
events such as pulmonary embolism, infection, and bleeding.
The proposed data element, IV Access (Peripheral IV, Midline,
Central Line), consists of the principal IV Access data element and
three response option sub-elements: Peripheral IV, Midline, and Central
Line. The proposed IV Access data element is not currently included on
any of the PAC assessment instruments, although there is a related
response option in the M1030 data element in the OASIS. We proposed to
replace the existing ``Intravenous or Infusion Therapy'' response
option of the M1030 data element in the OASIS with the IV Access
(Peripheral IV, Midline, Central Line) data element. For more
information on the IV Access data element, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The IV Access data element was first proposed as standardized
patient assessment data elements in the CY 2018 HH PPS proposed rule
(82 FR 35366). In that proposed rule, we stated that the proposal was
informed by input we received through a call for input published on the
CMS Measures Management System Blueprint website. Input was submitted
on one of the PAC PRD data elements, Central Line Management, from
August 12 to September 12, 2016. A central line is one type of IV
access. We stated that those commenters had supported the assessment of
central line management and recommended that the data element be
broadened to also include other types of IV access. Several commenters
noted feasibility and importance of facilitating care coordination and
care transitions. However, a few commenters recommended that the
definition of this data element be broadened to include peripherally
inserted central catheters (``PICC lines'') and midline IVs. Based on
public comment feedback and in consultation with expert input,
described elsewhere in this final rule with comment period, we created
an overarching IV Access data element with sub-elements for other types
of IV access in addition to central lines (that is, peripheral IV and
midline). This expanded version of IV Access is the data element being
proposed. A summary report for the August 12 to September 12, 2016
public comment period titled ``SPADE August 2016 Public Comment Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the IV Access data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the IV Access data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the IV
Access data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
IV Access data element in the National Beta Test can be found in the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
IV Access data element, the TEP supported the assessment of the special
services, treatments, and interventions included in the National Beta
Test with respect to both admission and discharge. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing IV access, stakeholder
input, and strong test results, we proposed that the IV access
(Peripheral IV, Midline, Central Line) data element with a principal
data element and three sub-elements meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the IV Access (Peripheral IV, Midline, Central Line)
data element as standardized patient assessment data for use in the HH
QRP.
We invited public comment on our proposal to collect as
standardized patient assessment data the IV Access data element. We did
not receive any comments specific to the IV Access (Peripheral IV,
Midline, Central Line) data element. General comments on the category
of Special Services, Treatments, and Interventions Data are discussed
in section V.H.2 of this final rule with comment period.
Accordingly, we are finalizing our proposal to adopt the
Intravenous (IV) Access (Peripheral IV, Midline, Central line) data
element as standardized patient assessment data beginning with the CY
2022 HH QRP as proposed.
l. Nutritional Approach: Parenteral/IV Feeding
In CY 2020 HH PPS proposed rule (84 FR 345667 through 34668), we
proposed that the Parenteral/IV Feeding data element meets the
definition of standardized patient assessment data with respect to
special services,
[[Page 60586]]
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35366
through 35367), parenteral nutrition/IV feeding refers to a patient or
resident being fed intravenously using an infusion pump, bypassing the
usual process of eating and digestion. The need for parenteral
nutrition/IV feeding indicates a clinical complexity that prevents the
patient or resident from meeting his or her nutritional needs
internally, and is more resource intensive than other forms of
nutrition, as it often requires monitoring of blood chemistries and
maintenance of a central line. Therefore, assessing a patient's or
resident's need for parenteral feeding is important for care planning
and resource use. In addition to the risks associated with central and
peripheral intravenous access, total parenteral nutrition is associated
with significant risks such as embolism and sepsis.
The proposed data element consists of the single Parenteral/IV
Feeding data element. The proposed Parenteral/IV Feeding data element
is currently in use in the MDS for SNFs, and equivalent or related data
elements are in use in the LCDS, IRF-PAI, and OASIS. We proposed to
replace the existing ``Parenteral nutrition (TPN or lipids)'' response
option of the M1030 data element in the OASIS with the proposed
Parenteral/IV Feeding data element. For more information on the
Parenteral/IV Feeding data element, we refer readers to the document
titled, ``Proposed Specifications for HH QRP Quality Measures and
SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Parenteral/IV Feeding data element was first proposed as a
standardized patient assessment data element in the CY 2018 HH PPS
proposed rule (82 FR 35366 through 35367). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted on Total Parenteral Nutrition (an
item with nearly the same meaning as the proposed data element, but
with the label used in the PAC PRD), which was included in a call for
public input from August 12 to September 12, 2016. We stated that
commenters had supported this data element, noting its relevance to
facilitating care coordination and supporting care transitions. After
the public comment period, the Total Parenteral Nutrition data element
was renamed Parenteral/IV Feeding, to be consistent with how this data
element is referred to in the MDS in SNFs. A summary report for the
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. In response to our proposal in
the CY 2018 HH PPS proposed rule, two commenters expressed support for
the Parenteral/IV Feeding data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Parenteral/IV Feeding data element was included in the
National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Parenteral/IV Feeding data element to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the Parenteral/IV Feeding data element in the
National Beta Test can be found in the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs,'' available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Parenteral/IV Feeding data element, the TEP supported the assessment of
the special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing parenteral/IV feeding,
stakeholder input, and strong test results, we proposed that the
Parenteral/IV Feeding data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Parenteral/IV Feeding data element as standardized patient
assessment data for use in the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Parenteral/IV Feeding data element.
Comment: One commenter was supportive of collecting the Parenteral/
IV Feeding data element, but noted that it should not be a substitute
for capturing information related to swallowing which reflects
additional patient complexity and resource use.
Response: We agree that the Parenteral/IV Feeding SPADE should not
be used as a substitute for an assessment of a patient's swallowing
function. The proposed SPADEs are not intended to replace comprehensive
clinical evaluation and in no way preclude providers from conducting
further patient evaluation or assessments in their settings as they
believe are necessary and useful. We agree that information related to
swallowing can capture patient complexity. However, we also note that
Parenteral/IV Feeding data element captures a different construct than
an evaluation of swallowing. That is, the Parenteral/IV Feeding data
element captures a patient's need to receive calories and nutrients
intravenously, while an assessment of swallowing would capture a
patient's functional ability to safely consume food/liquids orally for
digestion in their gastrointestinal tract.
After careful consideration of the public comment we received on
the Parenteral/IV Feeding data element, we are finalizing our proposal
to adopt the
[[Page 60587]]
Parenteral/IV Feeding data element as standardized patient assessment
data beginning with the CY 2022 HH QRP as proposed.
m. Nutritional Approach: Feeding Tube
In CY 2020 HH PPS proposed rule (84 FR 34668 through 34669), we
proposed that the Feeding Tube data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35367
through 35368), the majority of patients admitted to acute care
hospitals experience deterioration of their nutritional status during
their hospital stay, making assessment of nutritional status and method
of feeding if unable to eat orally very important in PAC. A feeding
tube can be inserted through the nose or the skin on the abdomen to
deliver liquid nutrition into the stomach or small intestine. Feeding
tubes are resource intensive and, therefore, are important to assess
for care planning and resource use. Patients with severe malnutrition
are at higher risk for a variety of complications.\114\ In PAC
settings, there are a variety of reasons that patients and residents
may not be able to eat orally (including clinical or cognitive status).
---------------------------------------------------------------------------
\114\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The
link between nutritional status and clinical outcome: Can
nutritional intervention modify it?'' Am J of Clinical Nutrition,
47(2): 352-356.
---------------------------------------------------------------------------
The proposed data element consists of the single Feeding Tube data
element. The Feeding Tube data element is currently included in the MDS
for SNFs, and in the OASIS for HHAs, where it is labeled ``Enteral
Nutrition (nasogastric, gastrostomy, jejunostomy, or any other
artificial entry into the alimentary canal)''. A related data element,
collected in the IRF-PAI for IRFs (Tube/Parenteral Feeding), assesses
use of both feeding tubes and parenteral nutrition. We proposed to
rename ``Enteral nutrition (nasogastric, gastrostomy, jejunostomy, or
any other artificial entry into the alimentary canal)'' data element to
``Feeding Tube,'' and adopt it as a SPADE for the HH QRP. For more
information on the Feeding Tube data element, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Feeding Tube data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35367 through 35368). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on an Enteral Nutrition data element (which is the same
as the data element we proposed in the CY 2020 HH PPS proposed rule (84
FR 34668), but is used in the OASIS under a different name) from August
12 to September 12, 2016 supported the data element, noting the
importance of assessing enteral nutrition status for facilitating care
coordination and care transitions. After the public comment period, the
Enteral Nutrition data element used in public comment was renamed
Feeding Tube, indicating the presence of an assistive device. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule, a
few commenters expressed support for the Feeding Tube data element. A
commenter also recommended that the term ``enteral feeding'' be used
instead of ``feeding tube.''
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Feeding Tube data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Feeding Tube data element to be feasible and reliable for use
with PAC patients and residents. More information about the performance
of the Feeding Tube data element in the National Beta Test can be found
in the document titled, ``Final Specifications for HH QRP Quality
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Feeding Tube data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing feeding tubes,
stakeholder input, and strong test results, we proposed that the
Feeding Tube data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Feeding Tube data element as standardized patient assessment data
for use in the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Feeding Tube data element.
Comment: In regard to the nutritional approach--feeding tube data
element, one commenter noted that in addition to identifying if the
patient is on a feeding tube or not, it would be important to assess
the patient's progression towards oral feeding within this data
element, as this impacts the tube feeding regimen.
Response: We agree that progression to oral feeding is important
for care planning and transfer. We wish to clarify that the proposed
SPADEs are
[[Page 60588]]
not intended to replace comprehensive clinical evaluation and in no way
preclude providers from conducting further patient evaluation or
assessments in their settings as they believe are necessary and useful.
However, we will take this recommendation into consideration in future
work on standardized data elements.
After careful consideration of the public comment we received, we
are finalizing our proposal to adopt the Feeding Tube data element as
standardized patient assessment data beginning with the CY 2022 HH QRP
as proposed.
n. Nutritional Approach: Mechanically Altered Diet
In CY 2020 HH PPS proposed rule (84 FR 34669), we proposed that the
Mechanically Altered Diet data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35368), the
Mechanically Altered Diet data element refers to food that has been
altered to make it easier for the patient or resident to chew and
swallow, and this type of diet is used for patients and residents who
have difficulty performing these functions. Patients with severe
malnutrition are at higher risk for a variety of complications.\115\
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\115\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The
link between nutritional status and clinical outcome: Can
nutritional intervention modify it?'' Am J of Clinical Nutrition,
47(2): 352-356.
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In PAC settings, there are a variety of reasons that patients and
residents may have impairments related to oral feedings, including
clinical or cognitive status. The provision of a mechanically altered
diet may be resource intensive, and can signal difficulties associated
with swallowing/eating safety, including dysphagia. In other cases, it
signifies the type of altered food source, such as ground or puree that
will enable the safe and thorough ingestion of nutritional substances
and ensure safe and adequate delivery of nourishment to the patient.
Often, patients and residents on mechanically altered diets also
require additional nursing supports such as individual feeding, or
direct observation, to ensure the safe consumption of the food product.
Assessing whether a patient or resident requires a mechanically altered
diet is therefore important for care planning and resource
identification.
The proposed data element consists of the single Mechanically
Altered Diet data element. The proposed data element for a mechanically
altered diet is currently included on the MDS for SNFs. A related data
element for modified food consistency/supervision is currently included
on the IRF-PAI for IRFs. Another related data element is included in
the OASIS for HHAs that collects information about independent eating
that requires ``a liquid, pureed or ground meat diet.'' For more
information on the Mechanically Altered Diet data element, we refer
readers to the document titled, ``Proposed Specifications for HH QRP
Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Mechanically Altered Diet data element was first proposed as a
standardized patient assessment data element in the CY 2018 HH PPS
proposed rule (82 FR 35368).
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Mechanically Altered Diet data
element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Mechanically Altered Diet data element was included in the
National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Mechanically Altered Diet data element to be feasible
and reliable for use with PAC patients and residents. More information
about the performance of the Mechanically Altered Diet data element in
the National Beta Test can be found in the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs,'' available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Mechanically Altered Diet data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing mechanically altered
diet, stakeholder input, and strong test results, we proposed that the
Mechanically Altered Diet data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Mechanically Altered Diet data element as
standardized patient assessment data for use in the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Mechanically Altered Diet data element.
Comment: One commenter was concerned that the Mechanically Altered
Diet data element does not capture clinical complexity and does not
provide any insight into resource allocation because it only measures
whether the patient needs a mechanically altered diet and not, for
example, the extent of help a patient needs in consuming his or her
meal.
Response: We believe that assessing patients' needs for
mechanically altered diets captures one piece of information about
resource intensity. That is, patients with this special nutritional
requirement may require additional nutritional planning services,
special meals, and staff to ensure that meals are prepared and served
in the way the patient needs. Additional factors that
[[Page 60589]]
would affect resource allocation, such as those noted by the commenter,
are not captured by this data element. We have attempted to balance the
scope and level of detail of the data elements against the potential
burden placed on providers who must complete the assessment. We will
take this suggestion into consideration in future refinement of the
clinical SPADEs.
After careful consideration of the public comment we received, we
are finalizing our proposal to adopt the Mechanically Altered Diet data
element as standardized patient assessment data beginning with the CY
2022 HH QRP as proposed.
o. Nutritional Approach: Therapeutic Diet
In CY 2020 HH PPS proposed rule (84 FR 34670), we proposed that the
Therapeutic Diet data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35368
through 35369), a therapeutic diet refers to meals planned to increase,
decrease, or eliminate specific foods or nutrients in a patient's or
resident's diet, such as a low-salt diet, for the purpose of treating a
medical condition. The use of therapeutic diets among patients and
residents in PAC provides insight on the clinical complexity of these
patients and residents and their multiple comorbidities. Therapeutic
diets are less resource intensive from the bedside nursing perspective,
but do signify one or more underlying clinical conditions that preclude
the patient from eating a regular diet. The communication among PAC
providers about whether a patient is receiving a particular therapeutic
diet is critical to ensure safe transitions of care.
The proposed data element consists of the single Therapeutic Diet
data element. The Therapeutic Diet data element is currently in use in
the MDS for SNFs. For more information on the Therapeutic Diet data
element, we refer readers to the document titled, ``Final
Specifications for HH QRP Quality Measures and SPADEs,'' available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Therapeutic Diet data element was first proposed as a
standardized patient assessment data element in the CY 2018 HH PPS
proposed rule (82 FR 35368 through 35369).
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Therapeutic Diet data element
and encouraged CMS to align with the Academy of Nutrition and Dietetics
definition of ``therapeutic diet.''
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Therapeutic Diet data element was included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Therapeutic Diet data element to be feasible and reliable for
use with PAC patients and residents. More information about the
performance of the Therapeutic Diet data element in the National Beta
Test can be found in the document titled, ``Proposed Specifications for
HH QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Therapeutic Diet data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing therapeutic diet,
stakeholder input, and strong test results, we proposed that the
Therapeutic Diet data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Therapeutic data element as standardized patient assessment
data for use in the HH QRP.
We invited comment on our proposal to collect as standardize
patient assessment data the Therapeutic Diet data element. We did not
receive any additional comments specific to the Therapeutic Diet data
element. General comments on the category of Special Services,
Treatments, and Interventions Data are discussed in section V.H.2 of
this final rule with comment period.
Accordingly, we are finalizing our proposal to adopt the
Therapeutic Diet data element as standardized patient assessment data
beginning with the CY 2022 HH QRP as proposed.
p. High-Risk Drug Classes: Use and Indication
In CY 2020 HH PPS proposed rule (84 FR 34670 through 34672), we
proposed that the High-Risk Drug Classes: Use and Indication data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
Most patients and residents receiving PAC services depend on short-
and long-term medications to manage their medical conditions. However,
as a treatment, medications are not without risk; medications are in
fact a leading cause of adverse events. A study by the U.S. Department
of Health and Human Services found that 31 percent of adverse events
that occurred in 2008 among hospitalized Medicare beneficiaries were
related to medication.\116\ Moreover, changes in a patient's condition,
medications, and transitions between care settings put patients and
residents at risk of medication errors and adverse drug events (ADEs).
ADEs may be caused by
[[Page 60590]]
medication errors such as drug omissions, errors in dosage, and errors
in dosing frequency.\117\
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\116\ U.S. Department of Health and Human Services. Office of
Inspector General. Daniel R. Levinson. Adverse Events in Hospitals:
National Incidence Among Medicare Beneficiaries. OEI-06-09-00090.
November 2010.
\117\ Boockvar KS, Liu S, Goldstein N, Nebeker J, Siu A, Fried
T. Prescribing discrepancies likely to cause adverse drug events
after patient transfer. Qual Saf Health Care. 2009;18(1):32-6.
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ADEs are known to occur across different types of healthcare. For
example, the incidence of ADEs in the outpatient setting has been
estimated at 1.15 ADEs per 100 person-months,\118\ while the rate of
ADEs in the long-term care setting is approximately 9.80 ADEs per 100
resident-months.\119\ In the hospital setting, the incidence has been
estimated at 15 ADEs per 100 admissions.\120\ In addition,
approximately half of all hospital-related medication errors and 20
percent of ADEs occur during transitions within, admission to, transfer
to, or discharge from a hospital.121 122 123 ADEs are more
common among older adults, who make up most patients and residents
receiving PAC services. The rate of emergency department visits for
ADEs is three times higher among adults 65 years of age and older
compared to that among those younger than age 65.\124\
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\118\ Gandhi TK, Seger AC, Overhage JM, et al. Outpatient
adverse drug events identified by screening electronic health
records. J Patient Saf 2010;6:91-6.doi:10.1097/PTS.0b013e3181dcae06.
\119\ Gurwitz JH, Field TS, Judge J, Rochon P, Harrold LR,
Cadoret C, et al. The incidence of adverse drug events in two large
academic long-term care facilities. Am J Med. 2005; 118(3):2518. Epub 2005/03/05. https://doi.org/10.1016/j.amjmed.2004.09.018 PMID: 15745723.
\120\ Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL, Yoon
C, Matheny ME, Bates DW. Occurrence of adverse, often preventable,
events in community hospitals involving nephrotoxic drugs or those
excreted by the kidney. Kidney Int. 2009; 76:1192-1198. [PubMed:
19759525]
\121\ Barnsteiner JH. Medication reconciliation: transfer of
medication information across settings-keeping it free from error. J
Infus Nurs. 2005;28(2 Suppl):31-36.
\122\ Rozich J, Roger, R. Medication safety: one organization's
approach to the challenge. Journal of Clinical Outcomes Management.
2001(8):27-34.
\123\ Gleason KM, Groszek JM, Sullivan C, Rooney D, Barnard C,
Noskin GA. Reconciliation of discrepancies in medication histories
and admission orders of newly hospitalized patients. Am J Health
Syst Pharm. 2004;61(16):1689-1695.
\124\ Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ,
Budnitz DS. US emergency department visits for outpatient adverse
drug events, 2013-2014. JAMA. doi: 10.1001/jama.2016.16201.
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Understanding the types of medication a patient is taking and the
reason for its use are key facets of a patient's treatment with respect
to medication. Some classes of drugs are associated with more risk than
others.\125\ We proposed one High-Risk Drug Class data element with six
sub-elements. The six medication classes response options are:
Anticoagulants; antiplatelets; hypoglycemics (including insulin);
opioids; antipsychotics; and antibiotics. These drug classes are high-
risk due to the adverse effects that may result from use. In
particular, bleeding risk is associated with anticoagulants and
antiplatelets; 126 127 fluid retention, heart failure, and
lactic acidosis are associated with hypoglycemics; \128\ misuse is
associated with opioids;\129\ fractures and strokes are associated with
antipsychotics; 130 131 and various adverse events such as
central nervous systems effects and gastrointestinal intolerance are
associated with antimicrobials,\132\ the larger category of medications
that include antibiotics. Moreover, some medications in five of the six
drug classes included as response options in this data element are
included in the 2019 Updated Beers Criteria[supreg] list as potentially
inappropriate medications for use in older adults.\133\ Finally,
although a complete medication list should record several important
attributes of each medication (for example, dosage, route, stop date),
recording an indication for the drug is of crucial importance.\134\
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\125\ Ibid.
\126\ Shoeb M, Fang MC. Assessing bleeding risk in patients
taking anticoagulants. J Thromb Thrombolysis. 2013;35(3):312-319.
doi: 10.1007/s11239-013-0899-7.
\127\ Melkonian M, Jarzebowski W, Pautas E. Bleeding risk of
antiplatelet drugs compared with oral anticoagulants in older
patients with atrial fibrillation: A systematic review and
meta[hyphen]analysis. J Thromb Haemost. 2017;15:1500-1510. DOI:
10.1111/jth.13697.
\128\ Hamnvik OP, McMahon GT. Balancing Risk and Benefit with
Oral Hypoglycemic Drugs. The Mount Sinai journal of medicine, New
York. 2009; 76:234-243.
\129\ Naples JG, Gellad WF, Hanlon JT. The Role of Opioid
Analgesics in Geriatric Pain Management. Clin Geriatr Med.
2016;32(4):725-735.
\130\ Rigler SK, Shireman TI, Cook-Wiens GJ, Ellerbeck EF,
Whittle JC, Mehr DR, Mahnken JD. Fracture risk in nursing home
residents initiating antipsychotic medications. J Am Geriatr Soc.
2013; 61(5):715-722. [PubMed: 23590366].
\131\ Wang S, Linkletter C, Dore D et al. Age, antipsychotics,
and the risk of ischemic stroke in the Veterans Health
Administration. Stroke 2012;43:28-31. doi:10.1161/
STROKEAHA.111.617191.
\132\ Faulkner CM, Cox HL, Williamson JC. Unique aspects of
antimicrobial use in older adults. Clin Infect Dis. 2005;40(7):997-
1004.
\133\ American Geriatrics Society 2019 Beers Criteria Update
Expert Panel. American Geriatrics Society 2019 Updated Beers
Criteria for Potentially Inappropriate Medication Use in Older
Adults. J Am Geriatr Soc 2019; 00:1-21. DOI: 10.1111/jgs.15767.
\134\ Li Y, Salmasian H, Harpaz R, Chase H, Friedman C.
Determining the reasons for medication prescriptions in the EHR
using knowledge and natural language processing. AMIA Annu Symp
Proc. 2011;2011:768-76.
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The High-Risk Drug Classes: Use and Indication data element
requires an assessor to record whether or not a patient is taking any
medications within six drug classes. The six response options for this
data element are high-risk drug classes with particular relevance to
PAC patients and residents, as identified by our data element
contractor. The six data response options are Anticoagulants,
Antiplatelets, Hypoglycemics, Opioids, Antipsychotics, and Antibiotics.
For each drug class, the assessor is asked to indicate if the patient
is taking any medications within the class, and, for drug classes in
which medications were being taken, whether indications for all drugs
in the class are noted in the medical record. For example, for the
response option Anticoagulants, if the assessor indicates that the
patient is taking anticoagulant medication, the assessor would then
indicate if an indication is recorded in the medication record for the
anticoagulant(s).
The High-Risk Drug Classes: Use and Indication data element that is
being proposed as a SPADE was developed as part of a larger set of data
elements to assess medication reconciliation, the process of obtaining
a patient's multiple medication lists and reconciling any
discrepancies. For more information on the High-Risk Drug Classes: Use
and Indication data element, we refer readers to the document titled,
``Proposed Specifications for HH QRP Quality Measures and SPADEs,''
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We sought public input on the relevance of conducting assessments
on medication reconciliation and specifically on the proposed High-Risk
Drug Classes: Use and Indication data element. Our data element
contractor presented data elements related to medication reconciliation
to the TEP convened on April 6 and 7, 2016. The TEP supported a focus
on high-risk drugs, because of higher potential for harm to patients
and residents, and were in favor of a data element to capture whether
or not indications for medications were recorded in the medical record.
A summary of the April 6 and 7, 2016 TEP meeting titled ``SPADE
Technical Expert Panel Summary (First Convening)'' is available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. Medication reconciliation data
elements were also discussed at a second TEP meeting on January 5 and
6, 2017, convened by our data element contractor.
[[Page 60591]]
At this meeting, the TEP agreed about the importance of evaluating
the medication reconciliation process, but disagreed about how this
could be accomplished through standardized assessment. The TEP also
disagreed about the usability and appropriateness of using the Beers
Criteria to identify high-risk medications,\135\ although they were
supportive of the other six drug classes named in the draft version of
the data element, which are the six drug classes being proposed as
response options in the proposed High-Risk Drug Classes: Use and
Indications SPADE. A summary of the January 5 and 6, 2017 TEP meeting
titled ``SPADE Technical Expert Panel Summary (Second Convening)'' is
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\135\ American Geriatrics Society 2015 Beers Criteria Update
Expert Panel. American Geriatrics Society. Updated Beers Criteria
for Potentially Inappropriate Medication Use in Older Adults. J Am
Geriatr Soc 2015; 63:2227-2246.
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We received public input on data elements related to medication
reconciliation through a call for input published on the CMS Measures
Management System Blueprint website. In input received from April 26 to
June 26, 2017, several commenters expressed support for the medication
reconciliation data elements that were put on display, noting the
importance of medication reconciliation in preventing medication errors
and stating that the items seemed feasible and clinically useful. A few
commenters were critical of the choice of ten drug classes posted
during that comment period--the six drug classes in the proposed SPADE,
along with antidepressants, diuretics, antianxiety, and hypnotics--
arguing that ADEs are not limited to high-risk drugs, and raised issues
related to training assessors to correctly complete a valid assessment
of medication reconciliation. A summary report for the April 26 to June
26, 2017 public comment period titled ``SPADE May-June 2017 Public
Comment Summary Report'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The High-Risk Drug Classes: Use and Indication data element was
included in the National Beta Test of candidate data elements conducted
by our data element contractor from November 2017 to August 2018.
Results of this test found the High-Risk Drug Classes: Use and
Indication data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
High-Risk Drug Classes: Use and Indication data element in the National
Beta Test can be found in the document titled, ''Final Specifications
for HH QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018. The TEP acknowledged the challenges of assessing
medication safety, and were supportive of some of the data elements
focused on medication reconciliation that were tested in the National
Beta Test. The TEP was especially supportive of the focus on the six
high-risk drug classes--which they identified from among other options
during the second convening of the TEP, described previously--and of
using these classes to assess whether the indication for a drug is
recorded. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts. These
activities provided updates on the field-testing work and solicited
feedback on data elements considered for standardization, including the
High-Risk Drug Classes: Use and Indication data element. One
stakeholder group was critical of the six drug classes included as
response options in the High-Risk Drug Classes: Use and Indication data
element, noting that potentially risky medications (for example, muscle
relaxants) are not included in this list; that there may be important
differences between drugs within classes (for example, more recent
versus older style antidepressants); and that drug allergy information
is not captured. Finally, on November 27, 2018, our data element
contractor hosted a public meeting of stakeholders to present the
results of the National Beta Test and solicit additional comments.
General input on the testing and item development process and concerns
about burden were received from stakeholders during this meeting and
via email through February 1, 2019. Additionally, one commenter
questioned whether the time to complete the High-Risk Drug Classes: Use
and Indication data element would differ across settings. A summary of
the public input received from the November 27, 2018 stakeholder
meeting titled ``Input on SPADEs Received After November 27, 2018
Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing high-risk drugs and for
whether or not indications are noted for high-risk drugs, stakeholder
input, and strong test results, we proposed that the High-Risk Drug
Classes: Use and Indication data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the High-Risk Drug Classes: Use and Indication data
element as standardized patient assessment data for use in the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the High-Risk Drug Classes: Use and Indication
data element.
Comment: One commenter raised the concern of assessing some high
risk drug classes, noting that assessing each patient for use of
opioids and antipsychotics could discourage appropriate use of these
medications in those with advanced illness or receiving palliative
care.
Response: We acknowledge commenters' concerns about potential
unintended consequences of limiting use of medications for patients
with a clinical need. We remain confident that HHAs will continue to
focus on appropriate management of pain and mental health issues for
all patients as part of their commitment to quality of care and ongoing
quality improvement efforts. CMS is also committed to monitor incoming
assessment data related to pain for unintended consequences and will be
prepared to take necessary steps based on monitoring findings.
After careful consideration of the public comment we received, we
are finalizing our proposal to adopt the
[[Page 60592]]
High-Risk Drug Classes: Use and Indication data element as standardized
patient assessment data beginning with the CY 2022 HH QRP as proposed.
3. Medical Condition and Comorbidity Data
Assessing medical conditions and comorbidities is critically
important for care planning and safety for patients and residents
receiving PAC services, and the standardized assessment of selected
medical conditions and comorbidities across PAC providers is important
for managing care transitions and understanding medical complexity.
We discuss our proposals for data elements related to the medical
condition of pain as standardized patient assessment data. Appropriate
pain management begins with a standardized assessment, and thereafter
establishing and implementing an overall plan of care that is person-
centered, multi-modal, and includes the treatment team and the patient.
Assessing and documenting the effect of pain on sleep, participation in
therapy, and other activities may provide information on undiagnosed
conditions and comorbidities and the level of care required, and do so
more objectively than subjective numerical scores. With that, we assess
that taken separately and together, these proposed data elements are
essential for care planning, consistency across transitions of care,
and identifying medical complexities, including undiagnosed conditions.
We also conclude that it is the standard of care to always consider the
risks and benefits associated with a personalized care plan, including
the risks of any pharmacological therapy, especially opioids.\136\ We
also conclude that in addition to assessing and appropriately treating
pain through the optimum mix of pharmacologic, non-pharmacologic, and
alternative therapies, while being cognizant of current prescribing
guidelines, clinicians in partnership with patients are best able to
mitigate factors that contribute to the current opioid crisis.\137\
\138\ \139\
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\136\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf
\137\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf
\138\ Fishman SM, Carr DB, Hogans B, et al. Scope and Nature of
Pain- and Analgesia-Related Content of the United States Medical
Licensing Examination (USMLE). Pain Med Malden Mass. 2018;19(3):449-
459. doi:10.1093/pm/pnx336.
\139\ Fishman SM, Young HM, Lucas Arwood E, et al. Core
competencies for pain management: results of an interprofessional
consensus summit. Pain Med Malden Mass. 2013;14(7):971-981.
doi:10.1111/pme.12107.
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In alignment with our Meaningful Measures Initiative, accurate
assessment of medical conditions and comorbidities of patients and
residents in PAC is expected to make care safer by reducing harm caused
in the delivery of care; promoting effective prevention and treatment
of chronic disease; strengthening person and family engagement as
partners in their care; and promoting effective communication and
coordination of care. The proposed SPADEs will enable or support
clinical decision-making and early clinical intervention; person-
centered, high quality care through: Facilitating better care
continuity and coordination; better data exchange and interoperability
between settings; and longitudinal outcome analysis. Therefore,
reliable data elements assessing medical conditions and comorbidities
are needed in order to initiate a management program that can optimize
a patient's or resident's prognosis and reduce the possibility of
adverse events.
We invited comment on our proposals to collect as standardized
patient assessment data the following data with respect to medical
conditions and comorbidities.
a. Pain Interference (Pain Effect on Sleep, Pain Interference With
Therapy Activities, and Pain Interference With Day-to-Day Activities).
In acknowledgement of the opioid crisis, we specifically sought
comment on whether or not we should add these pain items in light of
those concerns. Commenters were asked to address to what extent
collection of the data through patient queries might encourage
providers to prescribe opioids.
In CY 2020 HH PPS proposed rule (84 FR 34673 through 34675), we
proposed that a set of three data elements on the topic of Pain
Interference (Pain Effect on Sleep, Pain Interference with Therapy
Activities, and Pain Interference with Day-to-Day Activities) meet the
definition of standardized patient assessment data with respect to
medical conditions and comorbidities under section 1899B(b)(1)(B)(iv)
of the Act.
The practice of pain management began to undergo significant
changes in the 1990s because the inadequate, non-standardized, non-
evidence-based assessment and treatment of pain became a public health
issue.\140\ In pain management, a critical part of providing
comprehensive care is performance of a thorough initial evaluation,
including assessment of both the medical and any biopsychosocial
factors causing or contributing to the pain, with a treatment plan to
address the causes of pain and to manage pain that persists over
time.\141\ Quality pain management, based on current guidelines and
evidence-based practices, can minimize unnecessary opioid prescribing
both by offering alternatives or supplemental treatment to opioids and
by clearly stating when they may be appropriate, and how to utilize
risk-benefit analysis for opioid and non-opioid treatment
modalities.\142\
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\140\ Institute of Medicine. Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education, and
Research. Washington (DC): National Academies Press (US); 2011.
http://www.ncbi.nlm.nih.gov/books/NBK91497/.
\141\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
\142\ National Academies. Pain Management and the Opioid
Epidemic: Balancing Societal and Individual Benefits and Risks of
Prescription Opioid Use. Washington DC: National Academies of
Sciences, Engineering, and Medicine.; 2017.
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Pain is not a surprising symptom in PAC patients and residents,
where healing, recovery, and rehabilitation often require regaining
mobility and other functions after an acute event. Standardized
assessment of pain that interferes with function is an important first
step toward appropriate pain management in PAC settings. The National
Pain Strategy called for refined assessment items on the topic of pain,
and describes the need for these improved measures to be implemented in
PAC assessments.\143\ Further, the focus on pain interference, as
opposed to pain intensity or pain frequency, was supported by the TEP
convened by our data element contractor as an appropriate and
actionable metric for assessing pain. A summary of the September 17,
2018 TEP meeting titled ``SPADE Technical Expert Panel
[[Page 60593]]
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\143\ National Pain Strategy: A Comprehensive Population-Health
Level Strategy for Pain. https://iprcc.nih.gov/sites/default/files/HHSNational_Pain_Strategy_508C.pdf.
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We appreciate the important concerns related to the misuse and
overuse of opioids in the treatment of pain and to that end we note
that in this final rule with comment period we have also proposed a
SPADE in section V.H.2.p. of this rule that assess for the use of, as
well as importantly the indication for the use of high risk drugs,
including opioids. Further, in the CY 2017 HH PPS final rule (81 FR
76780) we adopted the Drug Regimen Review Conducted With Follow-Up for
Identified Issues--Post Acute Care (PAC) HH QRP measure, which assesses
whether PAC providers were responsive to potential or actual clinically
significant medication issue(s) including issues associated with use
and misuse of opioids for pain management, when such issues were
identified.
We also note that the proposed SPADEs related to pain assessment
are not associated with any particular approach to management. Since
the use of opioids is associated with serious complications,
particularly in the elderly, an array of successful non-pharmacologic
and non-opioid approaches to pain management may be considered.\144\
\145\ \146\ PAC providers have historically used a range of pain
management strategies, including non-steroidal anti-inflammatory drugs,
ice, transcutaneous electrical nerve stimulation (TENS) therapy,
supportive devices, acupuncture, and the like. In addition, non-
pharmacological interventions implemented for pain management include,
but are not limited to, biofeedback, application of heat/cold, massage,
physical therapy, nerve block, stretching and strengthening exercises,
chiropractic, electrical stimulation, radiotherapy, and
ultrasound.\147\ \148\ \149\
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\144\ Chau, D.L., Walker, V., Pai, L., & Cho, L.M. (2008).
Opiates and elderly: use and side effects. Clinical interventions in
aging, 3(2), 273-8.
\145\ Fine, P.G. (2009). Chronic Pain Management in Older
Adults: Special Considerations. Journal of Pain and Symptom
Management, 38(2): S4-S14.
\146\ Solomon, D.H., Rassen, J.A., Glynn, R.J., Garneau, K.,
Levin, R., Lee, J., & Schneeweiss, S.. (2010). Archives Internal
Medicine, 170(22):1979-1986.
\147\ Byrd L. Managing chronic pain in older adults: a long-term
care perspective. Annals of Long-Term Care: Clinical Care and Aging.
2013;21(12):34-40.
\148\ Kligler, B., Bair, M.J., Banerjea, R. et al. (2018).
Clinical Policy Recommendations from the VHA State-of-the-Art
Conference on Non-Pharmacological Approaches to Chronic
Musculoskeletal Pain. Journal of General Internal Medicine, 33(Suppl
1): 16. https://doi.org/10.1007/s11606-018-4323-z.
\149\ Chou, R., Deyo, R., Friedly, J., et al. (2017).
Nonpharmacologic Therapies for Low Back Pain: A Systematic Review
for an American College of Physicians Clinical Practice Guideline.
Annals of Internal Medicine, 166(7):493-505.
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We believe that standardized assessment of pain interference will
support PAC clinicians in applying best-practices in pain management
for chronic and acute pain, consistent with current clinical
guidelines. For example, the standardized assessment of both opioids
and pain interference would support providers in successfully tapering
patients/residents who arrive in the PAC setting with long-term use of
opioids onto non-pharmacologic treatments and non-opioid medications,
as recommended by the Society for Post-Acute and Long-Term Care
Medicine,\150\ and consistent with HHS's 5-Point Strategy To Combat the
Opioid Crisis \151\ which includes ``Better Pain Management.''
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\150\ Society for Post-Acute and Long-Term Care Medicine (AMDA).
(2018). Opioids in Nursing Homes: Position Statement. https://paltc.org/opioids%20in%20nursing%20homes.
\151\ https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/index.html.
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The Pain Interference data element set consists of three data
elements: Pain Effect on Sleep, Pain Interference with Therapy
Activities, and Pain Interference with Day-to-Day Activities. Pain
Effect on Sleep assesses the frequency with which pain affects a
patient's sleep. Pain Interference with Therapy Activities assesses the
frequency with which pain interferes with a patient's ability to
participate in therapies. The Pain Interference with Day-to-Day
Activities assesses the extent to which pain interferes with a
patient's ability to participate in day-to-day activities excluding
therapy.
A similar data element on the effect of pain on activities is
currently included in the OASIS. A similar data element on the effect
on sleep is currently included in the MDS instrument in SNFs. We
proposed to add the Pain Interference data element set (Pain Effect on
Sleep, Pain Interference with Therapy Activities, and Pain Interference
with Day-to-Day Activities) to the OASIS and to remove M1242, Frequency
of Pain Interfering with Patient's Activity or Movement. For more
information on the Pain Interference data elements, we refer readers to
the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We sought public input on the relevance of conducting assessments
on pain and specifically on the larger set of Pain Interview data
elements included in the National Beta Test. The proposed data elements
were supported by comments from the TEP meeting held by our data
element contractor on April 7 to 8, 2016. The TEP affirmed the
feasibility and clinical utility of pain as a concept in a standardized
assessment. The TEP agreed that data elements on pain interference with
ability to participate in therapies versus other activities should be
addressed. Further, during a more recent convening of the same TEP on
September 17, 2018, the TEP supported the interview-based pain data
elements included in the National Beta Test. The TEP members were
particularly supportive of the items that focused on how pain
interferes with activities (that is, Pain Interference data elements)
because understanding the extent to which pain interferes with function
would enable clinicians to determine the need for appropriate pain
treatment. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We held a public comment period in 2016 to solicit feedback on the
standardization of pain and several other items that were under
development in prior efforts, through a call for input published on the
CMS Measures Management System Blueprint website. From the prior public
comment period, we included several pain data elements (Pain Effect on
Sleep; Pain Interference--Therapy Activities; Pain Interference--Other
Activities) in a second call for public comment, also published on the
CMS Measures Management System Blueprint website, open from April 26 to
June 26, 2017. The items we sought comment on were modified from all
stakeholder and test efforts. Commenters provided general comments
about pain assessment in
[[Page 60594]]
general in addition to feedback on the specific pain items. A few
commenters shared their support for assessing pain, the potential for
pain assessment to improve the quality of care, and for the validity
and reliability of the data elements. Commenters affirmed that the item
of pain and the effect on sleep would be suitable for PAC settings.
Commenters' main concerns included redundancy with existing data
elements, feasibility and utility for cross-setting use, and the
applicability of interview-based items to patients and residents with
cognitive or communication impairments, and deficits. A summary report
for the April 26 to June 26, 2017 public comment period titled ``SPADE
May-June 2017 Public Comment Summary Report'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Pain Interference data elements were included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Pain Interference data elements to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the Pain Interference data elements in the National Beta
Test can be found in the document titled, ``Proposed Specifications for
HH QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. The TEP supported the
interview-based pain data elements included in the National Beta Test.
The TEP members were particularly supportive of the items that focused
on how pain interferes with activities (that is, Pain Interference data
elements), because understanding the extent to which pain interferes
with function would enable clinicians to determine the need for pain
treatment. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, one commenter expressed strong support for the
proposed pain SPADEs and was encouraged by the fact that this portion
of the assessment surpasses pain presence. A summary of the public
input received from the November 27, 2018 stakeholder meeting titled
``Input on SPADEs Received After November 27, 2018 Stakeholder
Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing the effect of pain on
function, stakeholder input, and strong test results, we proposed that
the set of Pain Interference data elements (Pain Effect on Sleep, Pain
Interference with Therapy Activities, and Pain Interference with Day--
to-Day Activities) meet the definition of standardized patient
assessment data with respect to medical conditions and comorbidities
under section 1899B(b)(1)(B)(iv) of the Act and to adopt the Pain
Interference data elements (Pain Effect on Sleep, Pain Interference
with Therapy Activities, and Pain Interference with Day-to-Day
Activities) as standardized patient assessment data for use in the HH
QRP.
We invited comment on our proposal and received the following
comments related to our proposal to adopt the Pain Interference (Pain
Effect on Sleep, Pain Interference with Therapy Activities, and Pain
Interference with Day-to-Day Activities) data elements.
Comment: Some commenters noted specific support for the
introduction of the new pain data elements that can assist providers in
care planning.
Response: CMS thanks commenters for their support of the pain
interference data elements. We believe that standardized assessment of
pain interference will support PAC clinicians in applying best-
practices in pain management for chronic and acute pain, consistent
with current clinical guidelines.
Comment: A commenter expressed concerns about the suitability of
the Pain Interference data elements for use in patients with cognitive
and communication deficits and recommended CMS consider the use of non-
verbal means to allow patients to respond to SPADEs related to pain.
Response: We appreciate the commenter's concern surrounding pain
assessment with patients with cognitive and communication deficits. The
Pain Interference interview SPADEs require that a patient be able to
communicate, whether verbally, in writing, or using another method.
Assessors may use non-verbal means to administer the questions (for
example, providing the questions and response in writing for a patient
with severe hearing impairment). Patients who are unable to communicate
by any means would not be required to complete the Pain Interference
interview SPADEs. In addition, we note that evidence suggests that pain
presence can be reliably assessed in non-communicative patients through
structural observational protocols. To that end, we tested
observational pain presence elements in the National Beta Test, but
chose not to propose those data elements as SPADEs at this time. We
will take the commenter's concern into consideration as the SPADEs are
monitored and refined in the future.
After careful consideration of the public comments we received, we
are finalizing our proposal to adopt the Pain Interference (Pain Effect
on Sleep, Pain Interference with Therapy Activities, and Pain
Interference with Day-to-Day Activities) data elements as standardized
patient assessment data beginning with the CY 2022 HH QRP as proposed.
4. Impairment Data
Hearing and vision impairments are conditions that, if unaddressed,
affect activities of daily living, communication, physical functioning,
rehabilitation outcomes, and overall quality of life. Sensory
limitations can lead to confusion in new settings, increase isolation,
contribute to mood disorders, and impede accurate assessment of other
medical conditions. Failure to appropriately assess, accommodate, and
treat these conditions increases the likelihood that patients and
residents will require more intensive and prolonged treatment. Onset of
these conditions can be gradual, so individualized assessment with
accurate screening tools and
[[Page 60595]]
follow-up evaluations are essential to determining which patients and
residents need hearing- or vision-specific medical attention or
assistive devices and accommodations, including auxiliary aids and/or
services, and to ensure that person-directed care plans are developed
to accommodate a patient's or resident's needs. Accurate diagnosis and
management of hearing or vision impairment would likely improve
rehabilitation outcomes and care transitions, including transition from
institutional-based care to the community. Accurate assessment of
hearing and vision impairment would be expected to lead to appropriate
treatment, accommodations, including the provision of auxiliary aids
and services during the stay, and ensure that patients and residents
continue to have their vision and hearing needs met when they leave the
facility. In addition, entities that receive Federal financial
assistance, such as through Medicare Parts A, C, and D, must take
appropriate steps to ensure effective communication for individuals
with disabilities, including provision of appropriate auxiliary aids
and services.\152\
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\152\ Section 504 of the Rehabilitation Act of 1973, section1557
of the Affordable Care Act, and their respective implementing
regulations. More information is available at: https://www.hhs.gov/civil-rights/for-individuals/disability/index.html, and https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html.
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In alignment with our Meaningful Measures Initiative, we expect
accurate individualized assessment, treatment, and accommodation of
hearing and vision impairments of patients and residents in PAC to make
care safer by reducing harm caused in the delivery of care; promoting
effective prevention and treatment of chronic disease; strengthening
person and family engagement as partners in their care; and promoting
effective communication and coordination of care. For example,
standardized assessment of hearing and vision impairments used in PAC
will support ensuring patient safety (for example, risk of falls),
identifying accommodations needed during the stay, and appropriate
support needs at the time of discharge or transfer. Standardized
assessment of these data elements will enable or support clinical
decision-making and early clinical intervention; person-centered, high
quality care (for example, facilitating better care continuity and
coordination); better data exchange and interoperability between
settings; and longitudinal outcome analysis. Therefore, reliable data
elements assessing hearing and vision impairments are needed to
initiate a management program that can optimize a patient's or
resident's prognosis and reduce the possibility of adverse events.
Comments on the category of impairments were also submitted by
stakeholders during the CY 2018 HH PPS proposed rule (82 FR 35369
through 35371) public comment period. We received public comments
regarding the Hearing and Vision data elements; no additional comments
were received about impairments in general.
We invited comment on our proposals to collect as standardized
patient assessment data the Hearing and Vision data elements with
respect to impairments.
a. Hearing
In CY 2020 HH PPS proposed rule (84 FR 34675 through 34676), we
proposed that the Hearing data element meets the definition of
standardized patient assessment data with respect to impairments under
section 1899B(b)(1)(B)(v) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35369
through 35370), accurate assessment of hearing impairment is important
in the PAC setting for care planning and resource use. Hearing
impairment has been associated with lower quality of life, including
poorer physical, mental, and social functioning, and emotional
health.153 154 Treatment and accommodation of hearing
impairment led to improved health outcomes, including but not limited
to quality of life. \155\ For example, hearing loss in elderly
individuals has been associated with depression and cognitive
impairment,156 157 158 higher rates of incident cognitive
impairment and cognitive decline,\159\ and less time in occupational
therapy.\160\ Accurate assessment of hearing impairment is important in
the PAC setting for care planning and defining resource use.
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\153\ Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL,
Nondahl DM. The impact of hearing loss on quality of life in older
adults. Gerontologist. 2003;43(5):661-668.
\154\ Hawkins K, Bottone FG, Jr., Ozminkowski RJ, et al. The
prevalence of hearing impairment and its burden on the quality of
life among adults with Medicare Supplement Insurance. Qual Life Res.
2012; 21(7):1135-1147.
\155\ Horn KL, McMahon NB, McMahon DC, Lewis JS, Barker M,
Gherini S. Functional use of the Nucleus 22-channel cochlear implant
in the elderly. The Laryngoscope. 1991; 101(3):284-288.
\156\ Sprinzl GM, Riechelmann H. Current trends in treating
hearing loss in elderly people: a review of the technology and
treatment options--a mini-review. Gerontology. 2010; 56(3):351-358.
\157\ Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing
Loss Prevalence and Risk Factors Among Older Adults in the United
States. The Journals of Gerontology Series A: Biological Sciences
and Medical Sciences. 2011; 66A(5):582-590.
\158\ Hawkins K, Bottone FG, Jr., Ozminkowski RJ, et al. The
prevalence of hearing impairment and its burden on the quality of
life among adults with Medicare Supplement Insurance. Qual Life Res.
2012; 21(7):1135-1147.
\159\ Lin FR, Metter EJ, O'Brien RJ, Resnick SM, Zonderman AB,
Ferrucci L. Hearing Loss and Incident Dementia. Arch Neurol. 2011;
68(2):214-220.
\160\ Cimarolli VR, Jung S. Intensity of Occupational Therapy
Utilization in Nursing Home Residents: The Role of Sensory
Impairments. J Am Med Dir Assoc. 2016;17(10):939-942.
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The proposed data element consists of the single Hearing data
element. This data consists of one question that assesses level of
hearing impairment. This data element is currently in use in the MDS in
SNFs. For more information on the Hearing data element, we refer
readers to the document titled, ``Proposed Specifications for HH QRP
Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Hearing data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35369 through 35370). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on the PAC PRD form of the data element (``Ability to
Hear'') from August 12 to September 12, 2016, recommended that hearing,
vision, and communication assessments be administered at the beginning
of patient assessment process. A summary report for the August 12 to
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter noted that resources would be needed for a change in the
OASIS to account for the Hearing data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Hearing data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the
Hearing data element to be feasible and reliable for use with PAC
patients
[[Page 60596]]
and residents. More information about the performance of the Hearing
data element in the National Beta Test can be found in the document
titled, ''Proposed Specifications for HH QRP Quality Measures and
SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on January
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs,
including the Hearing data element. The TEP affirmed the importance of
standardized assessment of hearing impairment in PAC patients and
residents. A summary of the January 5 and 6, 2017 TEP meeting titled
``SPADE Technical Expert Panel Summary (Second Convening)'' is
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, a commenter expressed support for the Hearing data
element and suggested administration at the beginning of the patient
assessment to maximize utility. A summary of the public input received
from the November 27, 2018 stakeholder meeting titled ``Input on SPADEs
Received After November 27, 2018 Stakeholder Meeting'' is available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Due to the relatively stable nature of hearing impairment, we
proposed that HHAs that submit the Hearing data element with respect to
SOC will be deemed to have submitted with respect to discharge. Taking
together the importance of assessing hearing, stakeholder input, and
strong test results, we proposed that the Hearing data element meets
the definition of standardized patient assessment data with respect to
impairments under section 1899B(b)(1)(B)(v) of the Act and to adopt the
Hearing data element as standardized patient assessment data for use in
the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Hearing data element.
Comment: With regard to the hearing data element, one commenter
suggested that CMS consider how hearing impairment impacts a patient's
ability to respond to the assessment tool in general.
Response: We intend to reinforce assessment tips and item rationale
through training, open door forums, and future rulemaking efforts. In
the existing guidance manual for the OASIS, we offer tips for
administration that direct assessors to take appropriate steps to
accommodate sensory and communication impairments when conducting the
assessment.
After careful consideration of the public comment we received, we
are finalizing our proposal to adopt the Hearing data element as
standardized patient assessment data beginning with the CY 2022 HH QRP
as proposed.
b. Vision
In CY 2020 HH PPS proposed rule (84 FR 34676 through 35677), we
proposed that the Vision data element meets the definition of
standardized patient assessment data with respect to impairments under
section 1899B(b)(1)(B)(v) of the Act.
As described in the CY 2018 HH PPS proposed rule (82 FR 35370
through 35371), evaluation of an individual's ability to see is
important for assessing risks such as falls and provides opportunities
for improvement through treatment and the provision of accommodations,
including auxiliary aids and services, which can safeguard patients and
residents and improve their overall quality of life. Further, vision
impairment is often a treatable risk factor associated with adverse
events and poor quality of life. For example, individuals with visual
impairment are more likely to experience falls and hip fracture, have
less mobility, and report depressive symptoms.161
162 163 164 165
166 167 Individualized initial screening can lead
to life-improving interventions such as accommodations, including the
provision of auxiliary aids and services, during the stay and/or
treatments that can improve vision and prevent or slow further vision
loss. In addition, vision impairment is often a treatable risk factor
associated with adverse events which can be prevented and accommodated
during the stay. Accurate assessment of vision impairment is important
in the HH setting for care planning and defining resource use.
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\161\ Colon-Emeric CS, Biggs DP, Schenck AP, Lyles KW. Risk
factors for hip fracture in skilled nursing facilities: who should
be evaluated? Osteoporos Int. 2003;14(6):484-489.
\162\ Freeman EE, Munoz B, Rubin G, West SK. Visual field loss
increases the risk of falls in older adults: the Salisbury eye
evaluation. Invest Ophthalmol Vis Sci. 2007;48(10):4445-4450.
\163\ Keepnews D, Capitman JA, Rosati RJ. Measuring patient-
level clinical outcomes of home health care. J Nurs Scholarsh.
2004;36(1):79-85.
\164\ Nguyen HT, Black SA, Ray LA, Espino DV, Markides KS.
Predictors of decline in MMSE scores among older Mexican Americans.
J Gerontol A Biol Sci Med Sci. 2002;57(3):M181-185.
\165\ Prager AJ, Liebmann JM, Cioffi GA, Blumberg DM. Self-
reported Function, Health Resource Use, and Total Health Care Costs
Among Medicare Beneficiaries With Glaucoma. JAMA ophthalmology.
2016;134(4):357-365.
\166\ Rovner BW, Ganguli M. Depression and disability associated
with impaired vision: The MoVies Project. J Am Geriatr Soc.
1998;46(5):617-619.
\167\ Tinetti ME, Ginter SF. The nursing home life-space
diameter. A measure of extent and frequency of mobility among
nursing home residents. J Am Geriatr Soc. 1990;38(12):1311-1315.
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The proposed data element consists of the single Vision (Ability To
See in Adequate Light) data element that consists of one question with
five response categories. The Vision data element that we proposed for
standardization was tested as part of the development of the MDS for
SNFs and is currently in use in that assessment. A similar data
element, but with different wording and fewer response option
categories, is in use in the OASIS. We are proposed to add the Vision
(Ability to See in Adequate Light) data element to the OASIS to replace
M1200, Vision. For more information on the Vision data element, we
refer readers to the document titled, ``Proposed Specifications for HH
QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Vision data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35370 through 35371). In that proposed rule, we stated that the
proposal was informed by input we received from August 12 to September
12, 2016, on the Ability to See in Adequate Light data element (version
tested in the PAC PRD
[[Page 60597]]
with three response categories) through a call for input published on
the CMS Measures Management System Blueprint website. The data element
on which we solicited input differed from the proposed data element,
but input submitted from August 12 to September 12, 2016 supported the
assessment of vision in PAC settings and the useful information a
vision data element would provide. We also stated that commenters had
noted that the Ability to See item would provide important information
that would facilitate care coordination and care planning, and
consequently improve the quality of care. Other commenters suggested it
would be helpful as an indicator of resource use and noted that the
item would provide useful information about the abilities of patients
and residents to care for themselves. Additional commenters noted that
the item could feasibly be implemented across PAC providers and that
its kappa scores from the PAC PRD support its validity. Some commenters
noted a preference for MDS version of the Vision data element over the
form put forward in public comment, citing the widespread use of this
data element. A summary report for the August 12 to September 12, 2016
public comment period titled ``SPADE August 2016 Public Comment Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter noted that resources would be needed for a change in the
OASIS to account for the Vision data element.
Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Vision data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Vision
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Vision data
element in the National Beta Test can be found in the document titled,
Proposed Specifications for HH QRP Quality Measures and SPADEs,''
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on January
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs
including the Vision data element. The TEP affirmed the importance of
standardized assessment of vision impairment in PAC patients and
residents. A summary of the January 5 and 6, 2017 TEP meeting titled
``SPADE Technical Expert Panel Summary (Second Convening)'' is
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, a commenter expressed support for the Vision data
element and suggested administration at the beginning of the patient
assessment to maximize utility. A summary of the public input received
from the November 27, 2018 stakeholder meeting titled ``Input on SPADEs
Received After November 27, 2018 Stakeholder Meeting'' is available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-ownloads-and-Videos.html.
Due to the relatively stable nature of vision impairment, we
proposed that HHAs that submit the Vision data element with respect to
SOC will be deemed to have submitted with respect to discharge. Taking
together the importance of assessing vision, stakeholder input, and
strong test results, we proposed that the Vision data element meets the
definition of standardized patient assessment data with respect to
impairments under section 1899B(b)(1)(B)(v) of the Act and to adopt the
Vision data element as standardized patient assessment data for use in
the HH QRP.
We invited comment on our proposal to collect as standardized
patient assessment data the Vision data element. We did not receive any
comments on this category of impairment data or on the Vision data
element.
Accordingly, we are finalizing our proposal to adopt the Vision
data element as standardized patient assessment data beginning with the
CY 2022 HH QRP as proposed.
5. New Category: Social Determinants of Health
a. Social Determinants of Health Data Collection To Inform Measures and
Other Purposes
Subparagraph (A) of section 2(d)(2) of the IMPACT Act requires CMS
to assess appropriate adjustments to quality measures, resource
measures, and other measures, and to assess and implement appropriate
adjustments to payment under Medicare based on those measures, after
taking into account studies conducted by ASPE on social risk factors
(described elsewhere in this final rule with comment period) and other
information, and based on an individual's health status and other
factors. Subparagraph (C) of section 2(d)(2) of the IMPACT Act further
requires the Secretary to carry out periodic analyses, at least every
three years, based on the factors referred to subparagraph (A) so as to
monitor changes in possible relationships. Subparagraph (B) of section
2(d)(2) of the IMPACT Act requires CMS to collect or otherwise obtain
access to data necessary to carry out the requirement of the paragraph
(both assessing adjustments described previously in such subparagraph
(A) and for periodic analyses in such subparagraph (C)). Accordingly we
proposed to use our authority under subparagraph (B) of section 2(d)(2)
of the IMPACT Act to establish a new data source for information to
meet the requirements of subparagraphs (A) and (C) of section 2(d)(2).
In the CY 2020 HH PPS proposed rule (84 FR 34677 through 34684), we
proposed to collect and access data about social determinants of health
(SDOH) in order to perform CMS' responsibilities under subparagraphs
(A) and (C) of section 2(d)(2) of the IMPACT Act, as explained in more
detail elsewhere in this final rule with comment period. Social
determinants of health, also known as social risk factors, or health-
related social needs, are the socioeconomic, cultural and environmental
circumstances in which individuals live that impact their health. We
proposed to collect information on seven proposed SDOH SPADE data
elements relating to race, ethnicity, preferred language, interpreter
services, health literacy, transportation, and social isolation; a
detailed discussion of each of the proposed SDOH data
[[Page 60598]]
elements is found in section IV.A.7.f.(ii). of this final rule with
comment period.
We also proposed to use the OASIS, the current version being OASIS-
D, described as the PAC assessment instrument for home health agencies
under section 1899B(a)(2)(B)(i) of the Act, to collect these data via
an existing data collection mechanism. We believe this approach will
provide CMS with access to data with respect to the requirements of
section 2(d)(2) of the IMPACT Act, while minimizing the reporting
burden on PAC health care providers by relying on a data reporting
mechanism already used and an existing system to which PAC providers
are already accustomed.
The IMPACT Act includes several requirements applicable to the
Secretary, in addition to those imposing new data reporting obligations
on certain PAC providers as discussed in section IV.A.7.f.(2). of this
final rule with comment period. Subparagraphs (A) and (B) of section
2(d)(1) of the IMPACT Act require the Secretary, acting through the
Office of the Assistant Secretary for Planning and Evaluation (ASPE),
to conduct two studies that examine the effect of risk factors,
including individuals' socioeconomic status, on quality, resource use
and other measures under the Medicare program. The first ASPE study was
completed in December 2016 and is discussed in this final rule with
comment period, and the second study is to be completed in the fall of
2019. We recognize that ASPE, in its studies, is considering a broader
range of social risk factors than the SDOH data elements in this final,
and address both PAC and non-PAC settings. We acknowledge that other
data elements may be useful to understand, and that some of those
elements may be of particular interest in non-PAC settings. For
example, for beneficiaries receiving care in the community, as opposed
to an in-patient facility, housing stability and food insecurity may be
more relevant. We will continue to take into account the findings from
both of ASPE's reports in future policy making.
One of the ASPE's first actions under the IMPACT Act was to
commission the National Academies of Sciences, Engineering and Medicine
(NASEM) to define and conceptualize socioeconomic status for the
purposes of ASPE's two studies under section 2(d)(1) of the IMPACT Act.
The NASEM convened a panel of experts in the field and conducted an
extensive literature review. Based on the information collected, the
2016 NASEM panel report titled, ``Accounting for Social Risk Factors in
Medicare Payment: Identifying Social Risk Factors,'' concluded that the
best way to assess how social processes and social relationships
influence key health-related outcomes in Medicare beneficiaries is
through a framework of social risk factors instead of socioeconomic
status. Social risk factors discussed in the NASEM report include
socioeconomic position, race, ethnicity, gender, social context, and
community context. These factors are discussed at length in chapter 2
of the NASEM report, entitled ``Social Risk Factors.'' \168\
Consequently NASEM framed the results of its report in terms of
``social risk factors'' rather than ``socioeconomic status'' or
``sociodemographic status.'' The full text of the ``Social Risk
Factors'' NASEM report is available for reading on the website at
https://www.nap.edu/read/21858/chapter/1.
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\168\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Chapter 2. Washington, DC: The
National Academies Press.
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Each of the data elements we proposed to collect and access
pursuant to our authority under section 2(d)(2)(B) of the IMPACT Act is
identified in the 2016 NASEM report as a social risk factor that has
been shown to impact care use, cost and outcomes for Medicare
beneficiaries. CMS uses the term social determinants of health (SDOH)
to denote social risk factors, which is consistent with the objectives
of Healthy People 2020.\169\
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\169\ Social Determinants of Health. Healthy People 2020.
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
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ASPE issued its first Report to Congress, entitled ``Social Risk
Factors and Performance Under Medicare's Value-Based Purchasing
Programs,'' under section 2(d)(1)(A) of the IMPACT Act on December 21,
2016.\170\ Using NASEM's social risk factors framework, ASPE focused on
the following social risk factors, in addition to disability: (1) Dual
enrollment in Medicare and Medicaid as a marker for low income; (2)
residence in a low-income area; (3) Black race; (4) Hispanic ethnicity;
and (5) residence in a rural area. ASPE acknowledged that the social
risk factors examined in its report were limited due to data
availability. The report also noted that the data necessary to
meaningfully attempt to reduce disparities and identify and reward
improved outcomes for beneficiaries with social risk factors have not
been collected consistently on a national level in post-acute care
settings. Where these data have been collected, the collection
frequently involves lengthy questionnaires. More information on the
Report to Congress on Social Risk Factors and Performance under
Medicare's Value-Based Purchasing Programs, including the full report,
is available on the website at https://aspe.hhs.gov/social-risk-factors-and-medicares-value-based-purchasing-programs-reports.
---------------------------------------------------------------------------
\170\ U.S. Department of Health and Human Services, Office of
the Assistant Secretary for Planning and Evaluation. 2016. Report to
Congress: Social Risk Factors and Performance Under Medicare's
Value-Based Payment Programs. Washington, DC.
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Section 2(d)(2) of the IMPACT Act relates to CMS activities and
imposes several responsibilities on the Secretary relating to quality,
resource use, and other measures under Medicare. As mentioned
previously, under of subparagraph (A) of section 2(d)(2) of the IMPACT
Act, the Secretary is required, on an ongoing basis, taking into
account the ASPE studies and other information, and based on an
individual's health status and other factors, to assess appropriate
adjustments to quality, resource use, and other measures, and to assess
and implement appropriate adjustments to Medicare payments based on
those measures. Section 2(d)(2)(A)(i) of the IMPACT Act applies to
measures adopted under subsections (c) and (d) of section 1899B of the
Act and to other measures under Medicare. However, our ability to
perform these analyses, and assess and make appropriate adjustments is
hindered by limits of existing data collections on SDOH data elements
for Medicare beneficiaries. In its first study in 2016, in discussing
the second study, ASPE noted that information related to many of the
specific factors listed in the IMPACT Act, such as health literacy,
limited English proficiency, and Medicare beneficiary activation, are
not available in Medicare data.
Subparagraph 2(d)(2)(A) of the IMPACT Act specifically requires the
Secretary to take the studies and considerations from ASPE's reports to
Congress, as well as other information as appropriate, into account in
assessing and implementing adjustments to measures and related payments
based on measures in Medicare. The results of the ASPE's first study
demonstrated that Medicare beneficiaries with social risk factors
tended to have worse outcomes on many quality measures, and providers
who treated a disproportionate share of beneficiaries with social risk
factors tended to have worse performance on quality measures. As a
result of these findings, ASPE suggested a three-pronged strategy to
[[Page 60599]]
guide the development of value-based payment programs under which all
Medicare beneficiaries receive the highest quality healthcare services
possible. The three components of this strategy are to: (1) Measure and
report quality of care for beneficiaries with social risk factors; (2)
set high, fair quality standards for care provided to all
beneficiaries; and (3) reward and support better outcomes for
beneficiaries with social risk factors. In discussing how measuring and
reporting quality for beneficiaries with social risk factors can be
applied to Medicare quality payment programs, the report offered nine
considerations across the three-pronged strategy, including enhancing
data collection and developing statistical techniques to allow
measurement and reporting of performance for beneficiaries with social
risk factors on key quality and resource use measures.
Congress, in section 2(d)(2)(B) of the IMPACT Act, required the
Secretary to collect or otherwise obtain access to the data necessary
to carry out the provisions of paragraph (2) of section 2(d)(2) of the
IMPACT Act through both new and existing data sources. Taking into
consideration NASEM's conceptual framework for social risk factors
discussed previously, ASPE's study, and considerations under section
2(d)(1)(A) of the IMPACT Act, as well as the current data constraints
of ASPE's first study and its suggested considerations, we proposed to
collect and access data about SDOH under section 2(d)(2) of the IMPACT
Act. Our collection and use of the SDOH data described in section
IV.A.7.f.(i). of this final rule with comment period, under section
2(d)(2) of the IMPACT Act, would be independent of our proposal
discussed in this final rule with comment period in section
IV.A.7.f.(2). of the preamble of this final rule with comment period
and our authority to require submission of that data for use as SPADE
under section 1899B(a)(1)(B) of the Act.
Accessing standardized data relating to the SDOH data elements on a
national level is necessary to permit CMS to conduct periodic analyses,
to assess appropriate adjustments to quality measures, resource use
measures, and other measures, and to assess and implement appropriate
adjustments to Medicare payments based on those measures. We agree with
ASPE's observations, in the value-based purchasing context, that the
ability to measure and track quality, outcomes, and costs for
beneficiaries with social risk factors over time is critical as
policymakers and providers seek to reduce disparities and improve care
for these groups. Collecting the data as proposed will provide the
basis for our periodic analyses of the relationship between an
individual's health status and other factors and quality, resource, and
other measures, as required by section 2(d)(2) of the IMPACT Act, and
to assess appropriate adjustments. These data would also permit us to
develop the statistical tools necessary to maximize the value of
Medicare data, reduce costs and improve the quality of care for all
beneficiaries. Collecting and accessing SDOH data in this way also
supports the three-part strategy put forth in the first ASPE report,
specifically ASPE's consideration to enhance data collection and
develop statistical techniques to allow measurement and reporting of
performance for beneficiaries with social risk factors on key quality
and resource use measures.
For the reasons discussed previously, we proposed under section
2(d)(2) of the IMPACT Act, to collect the data on the following SDOH:
(1) Race, as described in section V.G.5.b.(1). of this final rule with
comment period; (2) Ethnicity, described in section V.G.5.b.(1). of
this final rule with comment period; (3) Preferred Language, as
described in section V.G.5.(ii).(2). of this final rule with comment
period; (4) Interpreter Services, as described in section V.G.5.b.(2).
of this final rule with comment period; (5) Health Literacy, as
described in section V.G.5.b.(3). of this final rule with comment
period; (6) Transportation, as described in section V.G.5.(ii).(4). of
this final rule with comment period; and (7) Social Isolation, as
described in section V.G.5.b.(5). of this final rule with comment
period. 84 FR 34677 through 34684. These data elements are discussed in
more detail in section V.G.5. of this final rule with comment period.
Comment: One commenter noted that CMS did not state explicitly in
the rule whether it anticipates the SDOH SPADEs will be used in
adjusting measures and whether it believes that the IMPACT Act's
requirements make it likely the SPADEs will be considered for use in
future adjustments. The commenters recommended that CMS be circumspect
and transparent in its approaches to incorporating the data elements
proposed in payment and quality adjustments, such as by collecting
stakeholder feedback before implementing any adjustments.
Response: We thank the commenter for their comment. We intend to
use this data to assess the impact that the social determinants of
health have on health outcomes. We will continue to work with
stakeholders to promote transparency and support providers who serve
vulnerable populations, promote high quality care, and refine and
further implement SDOH SPADEs. We appreciate the comment on collecting
stakeholder feedback before implementing any adjustments to measures
based on the SDOH SPADEs. Collection of this data will help us identify
potential disparities, conduct analyses, and assess whether any risk
adjustments or other type of adjustments are needed. Any future policy
development based on this data would be done transparently, and involve
solicitation of stakeholder feedback through the notice and comment
rulemaking process as appropriate.
Comment: Some commenters stated that the inclusion of the new
proposed SPADEs, including SDOH data elements, will be burdensome for
providers and agencies to implement. Commenters stated that CMS should
explore obtaining this data through Medicare claims. They suggested
that the agency should explain why certain data elements can only be
obtained through OASIS and other patient assessment tools, rather than
through other means, and asked that CMS lay out a multi-year plan for
implementation because the current proposal for implementation is not
feasible. The commenters suggested that CMS consider reducing the
number of SDOH SPADE metrics to ensure questions and overall categories
do not create an undue burden and that the new SPADE measures be
transitioned by category in a stepwise fashion, allowing achievement of
the IMPACT Act requirements while interoperability continues to be
strengthened. They also urged CMS to consider a two-year voluntary
submission period when additional SPADEs are adopted into the HH QRP to
allow for vendor development, facility integration, and staff training,
and recommended that CMS provides funding and administrative support
for standardizing electronic medical records to ensure effective
operability across all post-acute sites.
Response: We thank the commenters for their comments, and we agree
that it is important to to minimize burden on providers. Under
subsections (A) and (C) of section 2(d)(2, the IMPACT Act requires that
CMS periodically assess appropriate adjustments to quality, resource
use, and other measures, and to assess and implement appropriate
adjustments to Medicare payments based on those measures. Section
2(d)(2)(A)(i) of the IMPACT Act applies to measures adopted under
subsections
[[Page 60600]]
(c) and (d) of section 1899B of the Act and to other measures under
Medicare. However, as stated above in this section, our ability to
perform these analyses, and assess and make appropriate adjustments is
hindered by limits of existing data collections on SDOH data elements
for Medicare beneficiaries. In its first study in 2016, ASPE noted that
information related to many of the specific factors listed in the
IMPACT Act, such as health literacy, limited English proficiency, and
Medicare beneficiary activation, are not available in Medicare data. We
will collect this SDOH data under the authority of subsection (B) of
section 2(d)(2) to obtain this level of detail. We will provide
technical assistance to organizations as they implement these
requirements and believe that the implementation timeline we proposed
and are finalizing in this rule is sufficient because some of the data
elements required may have already been collected by HHAs.
Comment: A few commenters noted concerns that the expanded
comprehensive assessment added documentation and that the length of
time it will take their clinicians to collect this data would be
burdensome. The commenters stated that CMS should not add additional
documentation burden to clinicians that add little value to patients or
agencies who provide skilled home health services. They stated that CMS
should not require agencies to collect SDOH data, which agencies have
no ability to address or impact because it only increases time, cost,
and frustration for patients and clinicians during the start of care
while CMS intends to decrease cash flow during the same period.
Response: We thank the commenters for their comments. We are
mindful of the increased obligation that is required though this
additional data collection. However, this data collection is highly
valuable. Accessing standardized data relating to the SDOH data
elements on a national level is necessary to permit CMS to conduct
periodic analyses, to assess appropriate adjustments to quality
measures, resource use measures, and other measures, and to assess and
implement appropriate adjustments to Medicare payments based on those
measures. Collecting the data as proposed will provide the basis for
our periodic analyses of the relationship between an individual's
health status and other factors and quality, resource use, and other
measures, as required by section 2(d)(2) of the IMPACT Act, and to
assess appropriate adjustments.
b. Standardized Patient Assessment Data
Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to
collect SPADEs with respect to other categories deemed necessary and
appropriate. In the CY 2020 HH PPS proposed rule (84 FR 34679) we
proposed to create a Social Determinants of Health SPADE category under
section 1899B(b)(1)(B)(vi) of the Act. In addition to collecting SDOH
data for the purposes outlined previously, under section 2(d)(2)(B), we
also proposed to collect as SPADE these same data elements (race,
ethnicity, preferred language, interpreter services, health literacy,
transportation, and social isolation) under section 1899B(b)(1)(B)(vi)
of the Act. We believe that this proposed new category of Social
Determinants of Health will inform provider understanding of individual
patient risk factors and treatment preferences, facilitate coordinated
care and care planning, and improve patient outcomes. We proposed to
deem this category necessary and appropriate, for the purposes of
SPADE, because using common standards and definitions for PAC data
elements is important in ensuring interoperable exchange of
longitudinal information between PAC providers and other providers to
facilitate coordinated care, continuity in care planning, and the
discharge planning process from post-acute care settings.
All of the Social Determinants of Health data elements we proposed
under section 1899B(b)(1)(B)(vi) of the Act have the capacity to take
into account treatment preferences and care goals of patients and to
inform our understanding of patient complexity and risk factors that
may affect care outcomes. While acknowledging the existence and
importance of additional SDOH, we proposed to assess some of the
factors relevant for patients receiving post-acute care that PAC
settings are in a position to impact through the provision of services
and supports, such as connecting patients with identified needs with
transportation programs, certified interpreters, or social support
programs.
As previously mentioned, and described in more detail elsewhere in
this final rule with comment period, we proposed to adopt the following
seven data elements as SPADE under the proposed Social Determinants of
Health category: Race, ethnicity, preferred language, interpreter
services, health literacy, transportation, and social isolation. To
select these data elements, we reviewed the research literature, a
number of validated assessment tools and frameworks for addressing SDOH
currently in use (for example, Health Leads, NASEM, Protocol for
Responding to and Assessing Patients' Assets, Risks, and Experiences
(PRAPARE), and ICD-10), and we engaged in discussions with
stakeholders. We also prioritized balancing the reporting burden for
PAC providers with our policy objective to collect SPADEs that will
inform care planning and coordination and quality improvement across
care settings. Furthermore, incorporating SDOH data elements into care
planning has the potential to reduce readmissions and help
beneficiaries achieve and maintain their health goals.
We also considered feedback received during a listening session
that we held on December 13, 2018. The purpose of the listening session
was to solicit feedback from health systems, research organizations,
advocacy organizations, state agencies, and other members of the public
on collecting patient-level data on SDOH across care settings,
including consideration of race, ethnicity, spoken language, health
literacy, social isolation, transportation, sex, gender identity, and
sexual orientation. We also gave participants an option to submit
written comments. A full summary of the listening session, titled
``Listening Session on Social Determinants of Health Data Elements:
Summary of Findings,'' includes a list of participating stakeholders
and their affiliations, and is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We solicited comment on these proposals and received the following
comments. A discussion of these comments, along with our responses,
appears in this section of this final rule with comment period.
Comment: Several commenters supported the inclusion of the seven
proposed SDOH data elements, ``race, ethnicity, preferred language,
interpreter services, health literacy, transportation, and social
isolation'' as data elements collected by HHAs. A commenter noted that
this supports the increasing attention on the critical role that social
factors place in individual and population health and the growing body
of evidence that shows addressing health-related social needs through
enhanced clinical-community linkages can improve health outcomes and
reduce costs. Another commenter stated that there are gaps in assessing
SDOH and they appreciate the considerable
[[Page 60601]]
time and energy that CMS has invested to develop these SPADEs.
Response: We thank the commenters for their support, and we agree
that collecting SDOH data elements can be useful in identifying and
addressing health disparities.
Comment: A few commenters expressed support for moving toward
population health and outcomes through the SDOH SPADEs, requested
clarification as to what the data will be used for, and inquired
whether the data is already collected in other manners.
Response: We thank the commenters for the feedback. We proposed the
collection of SDOH SPADEs as part of the requirements outlined in
section 1899B(b)(1) of the Act, and more specifically under the
category of standardized patient assessment data that we specified
under section 1899B(b)(1)(B)(vi) of the Act. SDOH data for home health
beneficiaries is not systematically available for home health providers
at this time. Collection of this data will enhance patient care,
interoperability, and coordinated care. The availability of
standardized data through this collection allows for common standards
and definitions to be used among the providers, thus ensuring
interoperable exchange in longitudinal information between post-acute
care providers and other providers. Additionally, standardizing the
collection of SDOH SPADES will allow providers to have a better
understanding of individual patient's risk factors and treatment
preferences, to facilitate better coordinated care and care planning
for their patients, and to monitor for improvements in patient
outcomes. Further, we are collecting these new SDOH SPADE data elements
under the authority of section 2(d)(2) of the IMPACT ACT in order to
assess appropriate adjustments to quality, resource use, and other
measures, and to assess and implement appropriate adjustments to
Medicare payments based on those measures.
Comment: Several commenters supported the inclusion of the seven
proposed SDOH data elements in the OASIS assessment instrument, as HHAs
serve populations affected by social determinants, but recommend
including additional factors within the SDOH SPADE category to ensure
that the full spectrum of social needs is examined. One commenter
suggested evaluating the abilities of the caregiver to support the
patient's care needs since any deficit could pose a risk to the health
and safety of the patient with advanced illness. A few other commenters
suggested that CMS consider adding level of education, food insecurity,
and the ability to secure medications to the SDOH assessment. Several
commenters stated that collecting sexual orientation and gender
identity data alongside the SDOH data elements is important in post-
acute care because sexual and gender minorities experience unique
cultural and environmental factors, including discrimination and
stigma, which can negatively affect access to elder services, health
services and health outcomes, and these identities also intersect with
the proposed SDOH data elements in unique ways that can create
additional barriers to care.
Response: We thank the commenters for the comments and agree that
SDOH should include a wide and ever-changing array of elements. In
considering which SDOH we proposed to collect, we balanced our policy
objective to collect SPADES that will inform care planning and
coordination and quality improvement across care settings with the
reporting burden for PAC providers. To select these data elements, we
reviewed the research literature, a number of validated assessment
tools and frameworks for addressing SDOH currently in use (for example,
Health Leads, National Academics of Sciences, Engineering, and Medicine
(NASEM), Protocol for Responding to and Assessing Patients' Assets,
Risks, and Experiences (PRAPARE), and ICD-10). We also engaged in
discussions with stakeholders. Ultimately, we decided to propose SDOH
SPADE data elements, some of which were identified in the 2016 NASEM
report, which was commissioned by Office of the Assistant Secretary for
Planning and Evaluation (ASPE). We will take the commenters' suggestion
to include additional or different SDOH under advisement as we continue
to improve and refine the SPADEs.
Comment: One commenter noted that it is unknown what the most
useful social risk data to collect is, and that collecting a
comprehensive record comes with significant administrative burden. They
support transforming general data collection categories into more
discrete data points that can be analyzed and aggregated for
programmatic strategies. They encouraged CMS to be mindful of
meaningful collection and the potential for data overload as well as
the ability to leverage existing data sources from across care
settings. Since SDOH have impacts far beyond the post-acute care (PAC)
setting, they cautioned CMS not to require data collection that cannot
be readily gathered, shared or replicated beyond the PAC setting. For
healthcare settings that have more established EHRs, the collection of
SDOH should be aligned and associated costs for gathering, sharing or
replicating considered. They also encouraged CMS to consider leveraging
data points from primary care visits and urged CMS to take a holistic
view of SDOH across the care continuum so that all care settings may
gather, collect or leverage this data efficiently and so that the
collection will yield the utmost impact.
Response: We thank the commenter for the comment, and we agree that
collecting SDOH data elements can be useful in identifying and
addressing health disparities. We also agree with the feedback that we
should be mindful of meaningful collection of SDOH data collection
efforts so that data elements that are selected are useful. This is one
of the reasons why we proposed SDOH SPADE data elements that were
identified in the 2016 National Academies of Sciences, Engineering, and
Medicine (NASEM) report, which was commissioned by the Office of the
Assistant Secretary for Planning and Evaluation (ASPE). Regarding the
commenter's suggestion that we consider how it can align existing and
future SDOH data elements to minimize burden on providers, we agree
that it is important to minimize duplication efforts and align data
collection as appropriate and to the extent possible, and will take
this under advisement for future consideration. We also intend to
solicit on the issue of whether we should collect SDOH data in other
health care settings.
(1) Race and Ethnicity
The persistence of racial and ethnic disparities in health and
health care is widely documented, including in PAC
settings.171 172 173 174
175 Despite the trend toward overall improvements in quality
of care and health outcomes, the Agency for Healthcare Research and
Quality, in its National Healthcare Quality and
[[Page 60602]]
Disparities Reports, consistently indicates that racial and ethnic
disparities persist, even after controlling for factors such as income,
geography, and insurance.\176\ For example, racial and ethnic
minorities tend to have higher rates of infant mortality, diabetes and
other chronic conditions, and visits to the emergency department, and
lower rates of having a usual source of care and receiving
immunizations such as the flu vaccine.\177\ Studies have also shown
that African Americans are significantly more likely than white
Americans to die prematurely from heart disease and stroke.\178\
However, our ability to identify and address racial and ethnic health
disparities has historically been constrained by data limitations,
particularly for smaller populations groups such as Asians, American
Indians and Alaska Natives, and Native Hawaiians and other Pacific
Islanders.\179\
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\171\ 2017 National Healthcare Quality and Disparities Report.
Rockville, MD: Agency for Healthcare Research and Quality; September
2018. AHRQ Pub. No. 18-0033-EF.
\172\ Fiscella, K. and Sanders, M.R. Racial and Ethnic
Disparities in the Quality of Health Care. (2016). Annual Review of
Public Health. 37:375-394.
\173\ 2018 National Impact Assessment of the Centers for
Medicare & Medicaid Services (CMS) Quality Measures Reports.
Baltimore, MD: U.S. Department of Health and Human Services, Centers
for Medicare and Medicaid Services; February 28, 2018.
\174\ Smedley, B.D., Stith, A.Y., & Nelson, A.R. (2003). Unequal
treatment: confronting racial and ethnic disparities in health care.
Washington, DC, National Academy Press.
\175\ Chase, J., Huang, L. and Russell, D. (2017). Racial/ethnic
disparities in disability outcomes among post-acute home care
patients. J of Aging and Health. 30(9):1406-1426.
\176\ National Healthcare Quality and Disparities Reports.
(December 2018). Agency for Healthcare Research and Quality,
Rockville, MD. http://www.ahrq.gov/research/findings/nhqrdr/index.html.
\177\ National Center for Health Statistics. Health, United
States, 2017: With special feature on mortality. Hyattsville,
Maryland. 2018.
\178\ HHS. Heart disease and African Americans. 2016b. (October
24, 2016). http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
\179\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Population Health and Public
Health Practice; Committee on Community-Based Solutions to Promote
Health Equity in the United States; Baciu A, Negussie Y, Geller A,
et al., editors. Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The
State of Health Disparities in the United States. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
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The ability to improve understanding of and address racial and
ethnic disparities in PAC outcomes requires the availability of better
data. There is currently a Race and Ethnicity data element, collected
in the MDS, LCDS, IRF-PAI, and OASIS, that consists of a single
question, which aligns with the 1997 Office of Management and Budget
(OMB) minimum data standards for federal data collection efforts.\180\
The 1997 OMB Standard lists five minimum categories of race: (1)
American Indian or Alaska Native; (2) Asian; (3) Black or African
American; (4) Native Hawaiian or Other Pacific Islander; (5) and White.
The 1997 OMB Standard also lists two minimum categories of ethnicity:
(1) Hispanic or Latino; and (2) Not Hispanic or Latino. The 2011 HHS
Data Standards requires a two-question format when self-identification
is used to collect data on race and ethnicity. Large federal surveys
such as the National Health Interview Survey, Behavioral Risk Factor
Surveillance System, and the National Survey on Drug Use and Health,
have implemented the 2011 HHS race and ethnicity data standards. CMS
has similarly updated the Medicare Current Beneficiary Survey, Medicare
Health Outcomes Survey, and the Health Insurance Marketplace
Application for Health Coverage with the 2011 HHS data standards. More
information about the HHS Race and Ethnicity Data Standards are
available on the website at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
---------------------------------------------------------------------------
\180\ ``Revisions to the Standards for the Classification of
Federal Data on Race and Ethnicity (Notice of Decision)''. Federal
Register 62:210 (October 30, 1997) pp. 58782-58790. Available from:
https://www.govinfo.gov/content/pkg/FR/1997/10/30/pdf/97/28653.pdf.
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In the CY 2020 HH PPS proposed rule (84 FR 34680 through 34681), we
proposed to revise the current Race and Ethnicity data element for
purposes of this proposal to conform to the 2011 HHS Data Standards for
person-level data collection, while also meeting the 1997 OMB minimum
data standards for race and ethnicity. Rather than one data element
that assesses both race and ethnicity, we proposed two separate data
elements: One for Race and one for Ethnicity, that would conform with
the 2011 HHS Data Standards and the 1997 OMB Standard. In accordance
with the 2011 HHS Data Standards, a two-question format would be used
for the proposed race and ethnicity data elements.
The proposed Race data element asks, ``What is your race?'' We
proposed to include 14 response options under the race data element:
(1) White; (2) Black or African American; (3) American Indian or Alaska
Native; (4) Asian Indian; (5) Chinese; (6) Filipino; (7) Japanese; (8)
Korean; (9) Vietnamese; (10) Other Asian; (11) Native Hawaiian; (12)
Guamanian or Chamorro; (13) Samoan; and, (14) Other Pacific Islander.
The proposed Ethnicity data element asks, ``Are you Hispanic,
Latino/a, or Spanish origin?'' We proposed to include five response
options under the ethnicity data element: (1) Not of Hispanic, Latino/
a, or Spanish origin; (2) Mexican, Mexican American, Chicano; (3)
Puerto Rican; (4) Cuban; and (5) Another Hispanic, Latino, or Spanish
Origin.
We believe that the two proposed data elements for race and
ethnicity conform to the 2011 HHS Data Standards for person-level data
collection, while also meeting the 1997 OMB minimum data standards for
race and ethnicity, because under those standards, more detailed
information on population groups can be collected if those additional
categories can be aggregated into the OMB minimum standard set of
categories.
In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the importance of improving response
options for race and ethnicity as a component of health care
assessments and for monitoring disparities. Some stakeholders
emphasized the importance of allowing for self-identification of race
and ethnicity for more categories than are included in the 2011 HHS
Standard to better reflect state and local diversity, while
acknowledging the burden of coding an open-ended health care assessment
question across different settings.
We believe that the proposed modified race and ethnicity data
elements more accurately reflect the diversity of the U.S. population
than the current race/ethnicity data element included in MDS, LCDS,
IRF-PAI, and OASIS.181 182 183 184 We believe, and research
consistently shows, that improving how race and ethnicity data are
collected is an important first step in improving quality of care and
health outcomes. Addressing disparities in access to care, quality of
care, and health outcomes for Medicare beneficiaries begins with
identifying and analyzing how SDOH, such as race and ethnicity, align
with disparities in these areas.\185\ Standardizing self-reported data
collection for race and ethnicity allows for the equal comparison of
data across multiple healthcare entities.\186\ By collecting and
[[Page 60603]]
analyzing these data, CMS and other healthcare entities will be able to
identify challenges and monitor progress. The growing diversity of the
U.S. population and knowledge of racial and ethnic disparities within
and across population groups supports the collection of more granular
data beyond the 1997 OMB minimum standard for reporting categories. The
2011 HHS race and ethnicity data standard includes additional detail
that may be used by PAC providers to target quality improvement efforts
for racial and ethnic groups experiencing disparate outcomes. For more
information on the Race and Ethnicity data elements, we refer readers
to the document titled ``Proposed Specifications for HH QRP Measures
and SPADEs,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\181\ Penman-Aguilar, A., Talih, M., Huang, D., Moonesinghe, R.,
Bouye, K., Beckles, G. (2016). Measurement of Health Disparities,
Health Inequities, and Social Determinants of Health to Support the
Advancement of Health Equity. J Public Health Manag Pract. 22 Suppl
1: S33-42.
\182\ Ramos, R., Davis, J.L., Ross, T., Grant, C.G., Green, B.L.
(2012). Measuring health disparities and health inequities: do you
have REGAL data? Qual Manag Health Care. 21(3):176-87.
\183\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
\184\ ``Revision of Standards for Maintaining, Collecting, and
Presenting Federal Data on Race and Ethnicity: Proposals From
Federal Interagency Working Group (Notice and Request for
Comments).'' Federal Register 82: 39 (March 1, 2017) p. 12242.
\185\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Population Health and Public
Health Practice; Committee on Community-Based Solutions to Promote
Health Equity in the United States; Baciu A, Negussie Y, Geller A,
et al., editors. Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The
State of Health Disparities in the United States. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
\186\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
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In an effort to standardize the submission of race and ethnicity
data among IRFs, HHAs, SNFs, and LTCHs, for the purposes outlined in
section 1899B(a)(1)(B) of the Act, while minimizing the reporting
burden, we proposed to adopt the Race and Ethnicity data elements
described previously as SPADEs with respect to the proposed Social
Determinants of Health category.
Specifically, we proposed to replace the current Race/Ethnicity
data element, M0140, with the proposed Race and Ethnicity data
elements. Due to the stable nature of Race/Ethnicity, we proposed that
HHAs that submit the Race and Ethnicity SPADEs with respect to SOC only
will be deemed to have submitted those SPADEs with respect to SOC, ROC,
and discharge, because it is unlikely that the assessment of those
SPADEs with respect to SOC will differ from the assessment of the same
SPADES with respect to ROC and discharge.
We solicited comment on these proposals.
Commenters submitted the following comments related to the proposed
rule's discussion of the Race and Ethnicity SPADEs. A discussion of
these comments, along with our responses, appears in this section of
this final rule with comment period.
Comment: A few commenters questioned the response options for race.
One commenter noted that the response options for race do not align
with those used in other government data, such as the U.S. Census or
the Office of Management and Budget (OMB). Some of the commenters also
stated these responses are not consistent with the recommendations made
in the 2009 NAESM (formerly Institute of Medicine) report. One
commenter pointed out that the report recommended using broader OMB
race categories and granular ethnicities chosen from a national
standard set that can be ``rolled up'' into the broader categories. The
commenters stated that it is unclear how CMS chose the 14 response
options under the race data element and the five options under the
ethnicity element and worried that these response options would add to
the confusion that already may exist for patients about what terms like
``race'' and ``ethnicity'' mean for the purposes of health care data
collection. The commenter also noted that CMS should confer directly
with experts in the issue to ensure patient assessments are collecting
the right data in the right way before these SDOH SPADEs are finalized.
Another commenter noted that the response options for race may not
include all races that should be reflected, such as Native African and
Middle Eastern. The commenter stated that the item should include
``check all that apply.'' They encouraged CMS to provide rationale for
the finalized list of response options. A commenter also urged CMS to
review the Race/Ethnicity options to ensure they align with the
www.wh.gov definitions as they are requirements for the Consolidated-
Clinical Document Architecture (C-CDA) and referenced in the US Core
Data for Interoperability (USCDI). They pointed out that the SDOH
elements will need to align options with the current Consumer
Assessment of Healthcare Providers and Systems (CAHPS) requirements and
other data reporting requirements, reducing burden for providers to
gather this information in multiple locations. The commenter stated
that this alignment is imperative to ensure data elements are
referenced from a single source of data entry for use across multiple
data reporting requirements and that this careful review will help
avoid administrative burdens.
Response: We agree that data elements used by CMS should, to the
extent possible, cross-reference with those used by other agencies. The
proposed race and ethnicity categories align with and are rolled up
into the 1997 OMB minimum data standards and conforming with the 2011
HHS Data Standards at https://aspe.hhs.gov/basic-report/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-and-disability-status. The race and ethnicity data
element that we proposed also includes ``Check all that apply''
language. As provided in the rationale of the proposed rule (84 FR
34680 through 34681), the 14 race categories and the 5 ethnicity
categories conform with the 2011 HHS Data Standards for person-level
data collection, which were developed in fulfillment of section 4302 of
the Affordable Care Act that required the Secretary of HHS to establish
data collection standards for race, ethnicity, sex, primary language,
and disability status.
The Section 4302 Standards Workgroup was formed through the HHS
Data Council, which is the principal, senior internal Departmental
forum and advisory body to the Secretary on health and human services
data policy and which coordinates HHS data collection and analysis
activities. The Workgroup included representatives from HHS, the OMB,
and the Census Bureau. The Workgroup examined current federal data
collection standards, adequacy of prior testing, and quality of the
data produced in prior surveys; consulted with statistical agencies and
programs; reviewed OMB data collection standards and the 2009 Institute
of Medicine report Race, Ethnicity, and Language Data: Standardization
for Health Care Quality Improvement; sought input from national
experts; and built on its members' experience with collecting and
analyzing demographic data. As a result of this Workgroup, a set of
data collection standards were developed, and then published for public
comment. This set of data collection standards is referred to as the
2011 HHS Data Standards (https://aspe.hhs.gov/basic-report/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-and-disability-status). The categories of race and
ethnicity under the 2011 HHS Data Standards allow for more detailed
information to be collected and the additional categories under the
2011 HHS Data Standards can be aggregated into the OMB minimum
standards set of categories. As noted in the proposed rule, we
conducted a listening session regarding the proposed SDOH data elements
regarding the importance of improving response options for race and
ethnicity as a component of health care assessments and for monitoring
disparities. Some stakeholders emphasized the importance of allowing
for self-identification of race and ethnicity for more categories than
are
[[Page 60604]]
included in the 2011 HHS Data Standards to better reflect state and
local diversity.
Regarding the commenter who urged CMS to review the proposed race
and ethnicity elements to ensure they align with the www.wh.gov
definitions, we believe the commenter may be referring to the 1997 OMB
minimum data standards as the White House's definitions. If so, then as
provided earlier in this response, the race and ethnicity categories
that were proposed do align with and are rolled up into the 1997 OMB
minimum data standards, which also align with CAHPS reporting
requirements.
Comment: One commenter stated that the degree of detail required
for the social determinants of health sections A1005 ethnicity (focus
on Hispanic, Latino/and Spanish origin) and A1010 race may be regarded
as intrusive and offensive to patients. This could potentially cause
refusal of home care or affect the provider-patient relationship and
patient satisfaction.
Response: We thank the commenter for their comment. Accessing
standardized data relating to the SDOH data elements on a national
level is necessary to permit CMS to conduct periodic analyses, to
assess appropriate adjustments to quality measures, resource use
measures, and other measures, and to assess and implement appropriate
adjustments to Medicare payments based on those measures. Collecting
the data as proposed will provide the basis for our periodic analyses
of the relationship between an individual's health status and other
factors and quality, resource use, and other measures, as required by
section 2(d)(2) of the IMPACT Act, and to assess appropriate
adjustments. Moreover, collection of race and ethnicity data, along
with the other SDOH data elements, contributes to higher quality
patient outcomes due to the ability to use the standardized,
interoperable data to facilitate coordinated care and improved patient
outcomes. Collection of data for these purposes is authorized under
1899B(a)(1)(B). With the high value of collecting this data in mind, we
do acknowledge the commenter's concerns about the potential for
patients to view the collection of this data as intrusive and
offensive, leading to service refusal or damaging the provide-patient
relationship and patient satisfaction. We will monitor the
implementation of these new data elements and modify the rule as
appropriate.
Providers are required to ask patients for responses to every SPADE
data element question required in this rule for the HH QRP, including
every SDOH SPADE question. However, patients are not required to
respond to any of the SDOH SPADE questions. If the patient declines to
or is unable to answer an SDOH SPADE question, the provider must
indicate this non-response in the documentation. Therefore, we believe
that the patient's wishes and concerns about privacy and whether the
question is intrusive are respected and adequately protected under this
policy.
(2) Preferred Language and Interpreter Services
More than 64 million Americans speak a language other than English
at home, and nearly 40 million of those individuals have limited
English proficiency (LEP).\187\ Individuals with LEP have been shown to
receive worse care and have poorer health outcomes, including higher
readmission rates.188 189 190 Communication with individuals
with LEP is an important component of high quality health care, which
starts by understanding the population in need of language services.
Unaddressed language barriers between a patient and provider care team
negatively affects the ability to identify and address individual
medical and non-medical care needs, to convey and understand clinical
information, as well as discharge and follow up instructions, all of
which are necessary for providing high quality care. Understanding the
communication assistance needs of patients with LEP, including
individuals who are Deaf or hard of hearing, is critical for ensuring
good outcomes.
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\187\ U.S. Census Bureau, 2013-2017 American Community Survey 5-
Year Estimates.
\188\ Karliner LS, Kim SE, Meltzer DO, Auerbach AD. Influence of
language barriers on outcomes of hospital care for general medicine
inpatients. J Hosp Med. 2010 May-Jun;5(5):276-82. doi: 10.1002/
jhm.658.
\189\ Kim EJ, Kim T, Paasche-Orlow MK, et al. Disparities in
Hypertension Associated with Limited English Proficiency. J Gen
Intern Med. 2017 Jun;32(6):632-639. doi: 10.1007/s11606-017-3999-9.
\190\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Washington, DC: The National
Academies Press.
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Presently, the preferred language of patients and need for
interpreter services are assessed in two PAC assessment tools. The LCDS
and the MDS use the same two data elements to assess preferred language
and whether a patient or resident needs or wants an interpreter to
communicate with health care staff. The MDS initially implemented
preferred language and interpreter services data elements to assess the
needs of SNF residents and patients and inform care planning. For
alignment purposes, the LCDS later adopted the same data elements for
LTCHs. The 2009 NASEM (formerly Institute of Medicine) report on
standardizing data for health care quality improvement emphasizes that
language and communication needs should be assessed as a standard part
of health care delivery and quality improvement strategies.\191\
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\191\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
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In developing our proposal for a standardized language data element
across PAC settings, we considered the current preferred language and
interpreter services data elements that are in LCDS and MDS. We also
considered the 2011 HHS Primary Language Data Standard and peer-
reviewed research. The current preferred language data element in LCDS
and MDS asks, ``What is your preferred language?'' Because the
preferred language data element is open-ended, the patient is able to
identify their preferred language, including American Sign Language
(ASL). Finally, we considered the recommendations from the 2009 NASEM
(formerly Institute of Medicine) report, ``Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.''
In it, the committee recommended that organizations evaluating a
patient's language and communication needs for health care purposes,
should collect data on the preferred spoken language and on an
individual's assessment of his/her level of English proficiency.
A second language data element in LCDS and MDS asks, ``Do you want
or need an interpreter to communicate with a doctor or health care
staff?'' and includes yes or no response options. In contrast, the 2011
HHS Primary Language Data Standard recommends either a single question
to assess how well someone speaks English or, if more granular
information is needed, a two-part question to assess whether a language
other than English is spoken at home and if so, identify that language.
However, neither option allows for a direct assessment of a patient's
preferred spoken or written language nor whether they want or need
interpreter services for communication with a doctor or care team, both
of which are an important part of assessing patient needs and the care
planning process. More information about the HHS Data Standard for
Primary Language is available on the website at
[[Page 60605]]
https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
Research consistently recommends collecting information about an
individual's preferred spoken language and evaluating those responses
for purposes of determining language access needs in health care.\192\
However, using ``preferred spoken language'' as the metric does not
adequately account for people whose preferred language is ASL, which
would necessitate adopting an additional data element to identify
visual language. The need to improve the assessment of language
preferences and communication needs across PAC settings should be
balanced with the burden associated with data collection on the
provider and patient. Therefore we proposed to use the Preferred
Language and Interpreter Services data elements currently in use on the
MDS and LCDS, on the OASIS.
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\192\ Guerino, P. and James, C. Race, Ethnicity, and Language
Preference in the Health Insurance Marketplaces 2017 Open Enrollment
Period. Centers for Medicare & Medicaid Services, Office of Minority
Health. Data Highlight: Volume 7--April 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf.
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In addition, we received feedback during the December 13, 2018
listening session on the importance of evaluating and acting on
language preferences early to facilitate communication and allowing for
patient self-identification of preferred language. Although the
discussion about language was focused on preferred spoken language,
there was general consensus among participants that stated language
preferences may or may not accurately indicate the need for interpreter
services, which supports collecting and evaluating data to determine
language preference, as well as the need for interpreter services. An
alternate suggestion was made to inquire about preferred language
specifically for discussing health or health care needs. While this
suggestion does allow for ASL as a response option, we do not have data
indicating how useful this question might be for assessing the desired
information and thus we are not including this question in our
proposal.
Improving how preferred language and need for interpreter services
data are collected is an important component of improving quality by
helping PAC providers and other providers understand patient needs and
develop plans to address them. For more information on the Preferred
Language and Interpreter Services data elements, we refer readers to
the document titled ``Final Specifications for HH QRP Measures and
SPADEs,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In an effort to standardize the submission of language data among
IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
proposed to adopt the Preferred Language and Interpreter Services data
elements currently used on the LCDS and MDS, and described previously,
as SPADES with respect to the Social Determinants of Health category.
Comment: Some commenters noted that preferred language, need for an
interpreter, access to transportation, and social isolation are
unlikely to change between admission and discharge. One commenter
disagrees with CMS's statement in the SNF, IRF and LTCH PPS FY 2020
final rules that ``[patient] circumstances may have changed over the
duration of their admission,'' and might change the answers to the
health literacy, access to transportation and social isolation items.
They acknowledge that for the SNF, IRF, and LTCH QRPs, CMS will allow
providers to collect the Language Preference and Interpreter Services
at just admission and they felt that CMS should do the same for other
SDOH SPADES and just require that they be collected at admission. For
example, they noted that Health Literacy is the degree to which
individuals have the capacity to obtain, process, and understand basic
health information and services needed to make appropriate health
decisions, and it is difficult to see how these elemental skills would
change over the course of a month-long HH episode. Thus, they
encouraged CMS to only require collection of all SDOH SPADEs with
respect to admission only.
Response: We thank the commenters for their comments. We agree that
Preferred Language and Interpreter Services should just be collected at
admission given that a patient's response is unlikely to change. We
disagree with the commenters that Health Literacy, Transportation and
Social Isolation are unlikely to change from admission to discharge.
Unlike the Vision, Hearing, Race, Ethnicity, Preferred Language, and
Interpreter Services SPADEs, we believe that the response to this data
element is likely to change from admission to discharge for some
patients. For example, some patients may develop health issues, such as
cognitive decline, during their stay that could impact their response
to health literacy thus changing their status at discharge. Cognitive
decline can impact a patient's ability to process and understand health
information. Similarly, losing a loved one or caregiver, which can
happen at any time, could impact someone's response on social isolation
and access to transportation. It is common for caregivers to provide
emotional support and access to transportation for those for those that
they provide caregiving. Therefore, we are finalizing that the
Preferred Language and Interpreter Services data elements would just be
collected at admission, which will align with the collection of those
elements in the IRF, SNF, and LTCH QRPs. We refer the reader to section
V.L of this final rule with comment period, where we discuss the
collection points for other SDOH SPADEs. For Health Literacy,
Transportation, and Social Isolation, we are finalizing that these
elements be collected upon admission and discharge, as described in
these sections of this final rule with comment period.
(3) Health Literacy
The Department of Health and Human Services defines health literacy
as ``the degree to which individuals have the capacity to obtain,
process, and understand basic health information and services needed to
make appropriate health decisions.'' \193\ Similar to language
barriers, low health literacy can interfere with communication between
the provider and patient and the ability for patients or their
caregivers to understand and follow treatment plans, including
medication management. Poor health literacy is linked to lower levels
of knowledge about health, worse health outcomes, and the receipt of
fewer preventive services, but higher medical costs and rates of
emergency department use.\194\
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\193\ U.S. Department of Health and Human Services, Office of
Disease Prevention and Health Promotion. National action plan to
improve health literacy. Washington (DC): Author; 2010.
\194\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Washington, DC: The National
Academies Press.
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Health literacy is prioritized by Healthy People 2020 as an
SDOH.\195\ Healthy People 2020 is a long-term, evidence-based effort
led by the Department of Health and Human Services that aims to
identify nationwide health improvement
[[Page 60606]]
priorities and improve the health of all Americans. Although not
designated as a social risk factor in NASEM's 2016 report on accounting
for social risk factors in Medicare payment, the NASEM report noted
that Health literacy is impacted by other social risk factors and can
affect access to care as well as quality of care and health
outcomes.\196\ Assessing for health literacy across PAC settings would
facilitate better care coordination and discharge planning. A
significant challenge in assessing the health literacy of individuals
is avoiding excessive burden on patients and health care providers. The
majority of existing, validated health literacy assessment tools use
multiple screening items, generally with no fewer than four, which
would make them burdensome if adopted in MDS, LCDS, IRF-PAI, and OASIS.
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\195\ Social Determinants of Health. Healthy People 2020.
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
\196\ U.S. Department of Health & Human Services, Office of the
Assistant Secretary for Planning and Evaluation. Report to Congress:
Social Risk Factors and Performance Under Medicare's Value-Based
Purchasing Programs. Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs. Washington, DC: 2016.
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The Single Item Literacy Screener (SILS) question asks, ``How often
do you need to have someone help you when you read instructions,
pamphlets, or other written material from your doctor or pharmacy?''
Possible response options are: (1) Never; (2) Rarely; (3) Sometimes;
(4) Often; and (5) Always. The SILS question, which assesses reading
ability (a primary component of health literacy), tested reasonably
well against the 36 item Short Test of Functional Health Literacy in
Adults (S-TOFHLA), a thoroughly vetted and widely adopted health
literacy test, in assessing the likelihood of low health literacy in an
adult sample from primary care practices participating in the Vermont
Diabetes Information System.197 198 The S-TOFHLA is a more
complex assessment instrument developed using actual hospital related
materials such as prescription bottle labels and appointment slips, and
often considered the instrument of choice for a detailed evaluation of
health literacy.\199\ Furthermore, the S-TOFHLA instrument is
proprietary and subject to purchase for individual entities or
users.\200\ Given that SILS is publicly available, shorter and easier
to administer than the full health literacy screen, and research found
that a positive result on the SILS demonstrates an increased likelihood
that an individual has low health literacy, we proposed to use the
single-item reading question for health literacy in the standardized
data collection across PAC settings. We believe that use of this data
element will provide sufficient information about the health literacy
of HH patients to facilitate appropriate care planning, care
coordination, and interoperable data exchange across PAC settings.
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\197\ Morris, N.S., MacLean, C.D., Chew, L.D., & Littenberg, B.
(2006). The Single Item Literacy Screener: evaluation of a brief
instrument to identify limited reading ability. BMC family practice,
7, 21. doi:10.1186/1471-2296-7-21.
\198\ Brice, J.H., Foster, M.B., Principe, S., Moss, C., Shofer,
F.S., Falk, R.J., Ferris, M.E., DeWalt, D.A. (2013). Single-item or
two-item literacy screener to predict the S-TOFHLA among adult
hemodialysis patients. Patient Educ Couns. 94(1):71-5.
\199\ University of Miami, School of Nursing & Health Studies,
Center of Excellence for Health Disparities Research. Test of
Functional Health Literacy in Adults (TOFHLA). (March 2019).
Available from: https://elcentro.sonhs.miami.edu/research/measures-library/tofhla/index.html.
\200\ Nurss, J.R., Parker, R.M., Williams, M.V., &Baker, D.W.
David W. (2001). TOFHLA. Peppercorn Books & Press. Available from:
http://www.peppercornbooks.com/catalog/information.php?info_id=5.
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In addition, we received feedback during the December 13, 2018 SDOH
listening session on the importance of recognizing health literacy as
more than understanding written materials and filling out forms, as it
is also important to evaluate whether patients understand their
conditions. However, the NASEM recently recommended that health care
providers implement health literacy universal precautions instead of
taking steps to ensure care is provided at an appropriate literacy
level based on individualized assessment of health literacy.\201\ Given
the dearth of Medicare data on health literacy and gaps in addressing
health literacy in practice, we recommend the addition of a health
literacy data element.
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\201\ Hudson, S., Rikard, R.V., Staiculescu, I. & Edison, K.
(2017). Improving health and the bottom line: The case for health
literacy. In Building the case for health literacy: Proceedings of a
workshop. Washington, DC: The National Academies Press.
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The proposed Health Literacy data element is consistent with
considerations raised by NASEM and other stakeholders and research on
health literacy, which demonstrates an impact on health care use, cost,
and outcomes.\202\ For more information on the proposed Health Literacy
data element, we refer readers to the document titled ``Proposed
Specifications for HH QRP Measures and SPADEs,'' available on the
website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\202\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for Social Risk Factors in Medicare Payment:
Identifying Social Risk Factors. Washington, DC: The National
Academies Press.
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In an effort to standardize the submission of health literacy data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
proposed to adopt the SILS question, described previously for the
Health Literacy data element, as SPADE under the Social Determinants of
Health category. We proposed to add the Health Literacy data element to
the OASIS. We solicited comment on this proposal. A discussion of the
comment, along with our response, appears in this of this final rule
with comment period.
Comment: One commenter stated that the health literacy question
could be improved to capture whether the patient can read, understand,
and implement/respond to the information. In addition, the commenter
stated that the question does not take into account whether a patient's
need for help is due to limited vision, which is different from the
purpose of the separate Vision Impairment data element. Another
possible question the commenter suggested was ``How often do you have
difficulty?'' The commenter suggested that a single construct may not
be sufficient for this area, depending on the aspect of health literacy
that CMS intends to identify.
Response: We appreciate this commenter's suggestions. We proposed
the Single Item Literacy Screener (SILS) to minimize burden and based
on stakeholder feedback. We also conducted a listening session
regarding the proposed SDOH data elements regarding the importance of
collecting health literacy as a component of health care assessments
and the listening session stakeholders generally supported the SILS
option. Regarding the potential impacts of impaired vision, we do want
to note that this rule adopts a vision data element that will be
included on the OASIS instrument. The data on a patient's vision will
be helpful with the health literacy question to gain a comprehensive
picture of the patient's functioning.
(4) Transportation
Transportation barriers commonly affect access to necessary health
care, causing missed appointments, delayed care, and unfilled
prescriptions, all of which can have a negative impact on health
outcomes.\203\ Access to
[[Page 60607]]
transportation for ongoing health care and medication access needs,
particularly for those with chronic diseases, is essential to
successful chronic disease management. Adopting a data element to
collect and analyze information regarding transportation needs across
PAC settings would facilitate the connection to programs that can
address identified needs. We therefore proposed to adopt as SPADE a
single transportation data element that is from the Protocol for
Responding to and Assessing Patients' Assets, Risks, and Experiences
(PRAPARE) assessment tool and currently part of the Accountable Health
Communities (AHC) Screening Tool.
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\203\ Syed, S.T., Gerber, B.S., and Sharp, L.K. (2013).
Traveling Towards Disease: Transportation Barriers to Health Care
Access. J Community Health. 38(5): 976-993.
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The proposed Transportation data element from the PRAPARE tool
asks, ``Has a lack of transportation kept you from medical
appointments, meetings, work, or from getting things needed for daily
living?'' The three response options are: (1) Yes, it has kept me from
medical appointments or from getting my medications; (2) Yes, it has
kept me from non-medical meetings, appointments, work, or from getting
things that I need; and (3) No. The patient would be given the option
to select all responses that apply. We proposed to use the
transportation data element from the PRAPARE Tool, with permission from
National Association of Community Health Centers (NACHC), after
considering research on the importance of addressing transportation
needs as a critical SDOH.\204\
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\204\ Health Research & Educational Trust. (2017, November).
Social determinants of health series: Transportation and the role of
hospitals. Chicago, IL. Available at www.aha.org/transportation.www.aha.org/transportation.
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The proposed data element is responsive to research on the
importance of addressing transportation needs as a critical SDOH and
would adopt the Transportation item from the PRAPARE tool.\205\ This
data element comes from the national PRAPARE social determinants of
health assessment protocol, developed and owned by NACHC, in
partnership with the Association of Asian Pacific Community Health
Organization, the Oregon Primary Care Association, and the Institute
for Alternative Futures. Similarly the Transportation data element used
in the AHC Screening Tool was adapted from the PRAPARE tool. The AHC
screening tool was implemented by the Center for Medicare and Medicaid
Innovation's AHC Model and developed by a panel of interdisciplinary
experts that looked at evidence-based ways to measure SDOH, including
transportation. While the transportation access data element in the AHC
screening tool serves the same purposes as our proposed SPADE
collection about transportation barriers, the AHC tool has binary yes
or no response options that do not differentiate between challenges for
medical versus non-medical appointments and activities. We believe that
this is an important nuance for informing PAC discharge planning to a
community setting, as transportation needs for non-medical activities
may differ than for medical activities and should be taken into
account.\206\ We believe that use of this data element will provide
sufficient information about transportation barriers to medical and
non-medical care for HH patients to facilitate appropriate discharge
planning and care coordination across PAC settings. As such, we
proposed to adopt the Transportation data element from PRAPARE. More
information about development of the PRAPARE tool is available on the
website at https://protect2.fireeye.com/url?k=7cb6eb44-20e2f238-7cb6da7b-0cc47adc5fa2-1751cb986c8c2f8c&u=http://www.nachc.org/prapare.
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\205\ Health Research & Educational Trust. (2017, November).
Social determinants of health series: Transportation and the role of
hospitals. Chicago, IL. Available at www.aha.org/transportation.
\206\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
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In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the impact of transportation
barriers on unmet care needs. While recognizing that there is no
consensus in the field about whether providers should have
responsibility for resolving patient transportation needs, discussion
focused on the importance of assessing transportation barriers to
facilitate connections with available community resources.
Adding a Transportation data element to the collection of SPADE
would be an important step to identifying and addressing SDOH that
impact health outcomes and patient experience for Medicare
beneficiaries. For more information on the Transportation data element,
we refer readers to the document titled ``Final Specifications for HH
QRP Measures and SPADEs,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In an effort to standardize the submission of transportation data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
proposed to adopt the Transportation data element described previously
as SPADE with respect to the proposed Social Determinants of Health
category. If finalized as proposed, we would add the Transportation
data element to the OASIS.
We solicited comment on this proposal. A discussion of the comment
received, along with our responses appears in this section of this
final rule with comment period.
Comment: One commenter supported the collection of data to capture
the reason(s) transportation affects a patient's access to health care.
The commenter appreciated the inclusion of these items on the HHA and
encouraged exploration of quality measures in this area as
transportation is an extremely important instrumental activity of daily
living to effectively transition to the community.
Response: We thank the commenter for the comment and we will
consider this feedback as we continue to improve and refine our quality
measures.
(5) Social Isolation
Distinct from loneliness, social isolation refers to an actual or
perceived lack of contact with other people, such as living alone or
residing in a remote area.207 208 Social isolation tends to
increase with age, is a risk factor for physical and mental illness,
and a predictor of mortality.209 210 211 Post-acute care
providers are well-suited to design and implement programs to increase
social engagement of patients, while also taking into account
individual needs and preferences. Adopting a data element to collect
and analyze information about social isolation for patients receiving
HH
[[Page 60608]]
services and across PAC settings would facilitate the identification of
patients who are socially isolated and who may benefit from engagement
efforts.
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\207\ Tomaka, J., Thompson, S., and Palacios, R. (2006). The
Relation of Social Isolation, Loneliness, and Social Support to
Disease Outcomes Among the Elderly. J of Aging and Health. 18(3):
359-384.
\208\ Social Connectedness and Engagement Technology for Long-
Term and Post-Acute Care: A Primer and Provider Selection Guide.
(2019). Leading Age. Available at https://www.leadingage.org/white-papers/social-connectedness-and-engagement-technology-long-term-and-post-acute-care-primer-and#1.1.
\209\ Landeiro, F., Barrows, P., Nuttall Musson, E., Gray, A.M.,
and Leal, J. (2017). Reducing Social Loneliness in Older People: A
Systematic Review Protocol. BMJ Open. 7(5): e013778.
\210\ Ong, A.D., Uchino, B.N., and Wethington, E. (2016).
Loneliness and Health in Older Adults: A Mini-Review and Synthesis.
Gerontology. 62:443-449.
\211\ Leigh-Hunt, N., Bagguley, D., Bash, K., Turner, V.,
Turnbull, S., Valtorta, N., and Caan, W. (2017). An overview of
systematic reviews on the public health consequences of social
isolation and loneliness. Public Health. 152:157-171.
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We proposed to adopt as SPADE a single social isolation data
element that is currently part of the AHC Screening Tool. The AHC item
was selected from the Patient-Reported Outcomes Measurement Information
System (PROMIS[supreg]) Item Bank on Emotional Distress, and asks,
``How often do you feel lonely or isolated from those around you?'' The
five response options are: (1) Never; (2) Rarely; (3) Sometimes; (4)
Often; and (5) Always.\212\ The AHC Screening Tool was developed by a
panel of interdisciplinary experts that looked at evidence-based ways
to measure SDOH, including social isolation. More information about the
AHC Screening Tool is available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
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\212\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
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In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the value of receiving information
on social isolation for purposes of care planning. Some stakeholders
also recommended assessing social isolation as an SDOH as opposed to
social support.
The proposed Social Isolation data element is consistent with NASEM
considerations about social isolation as a function of social
relationships that impacts health outcomes and increases mortality
risk, as well as the current work of a NASEM committee examining how
social isolation and loneliness impact health outcomes in adults 50
years and older. We believe that adding a Social Isolation data element
would be an important component of better understanding patient
complexity and the care goals of patients, thereby facilitating care
coordination and continuity in care planning across PAC settings. For
more information on the Social Isolation data element, we refer readers
to the document titled ``Proposed Specifications for HH QRP Measures
and SPADEs,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In an effort to standardize the submission of data about social
isolation among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined
in section 1899B(a)(1)(B) of the Act, while minimizing the reporting
burden, we proposed to adopt the Social Isolation data element
described previously as SPADE with respect to the proposed Social
Determinants of Health category. We proposed to add the Social
Isolation data element to the OASIS.
We solicited comment on this proposal. A discussion of the comment,
along with our response, appears in this section of this final rule
with comment period.
Comment: One commenter stated that the proposed question on social
isolation may solicit different answers based on the time horizon
considered by the beneficiary as beneficiaries who are newly admitted
to an HHA may have experienced differing levels of social isolation
throughout their time in acute and post-acute care due to interactions
with health care providers, emergency providers, and friends or family
visiting due to hospitalization. The commenter believes this question
could be improved by adding timeframe to the question. For example,
``How often have you felt lonely or isolated from those around you in
the past six months?''.
Response: We thank the commenter for this comment and we will take
it under advisement for future consideration. The social isolation
question proposed is currently part of the Accountable Health
Communities (AHC) Screening Tool. The AHC item was selected from the
Patient-Reported Outcomes Measurement Information System
(PROMIS[supreg]) Item Bank on Emotional Distress. At this time, we do
not believe that we should add a time horizon to the social isolation
question. During cognitive testing of the proposed social isolation
question, there was no evidence of confusion related to the time
covered.\213\ We will continue to monitor if this is an area that needs
further clarification to satisfy the social isolation data element.
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\213\ National Association of Community Health Centers,
``PRAPARE'' available at http://www.nachc.org/research-and-data/prapare/.
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After consideration of the public comments, we are finalizing our
proposals to collect SDOH data for the purposes of section 2(d)(2) of
the IMPACT Act and section 1899B(b)(1)(B)(vi) of the Act as follows.
With regard to Race, Ethnicity, Health Literacy, Transportation, and
Social Isolation, we are finalizing our proposals as proposed. In
response to stakeholder comments, we are finalizing that HHAs that
submit the Preferred Language and Interpreter Services SPADEs with
respect to admission will be deemed to have submitted with respect to
both admission and discharge.
J. Codification of the Home Health Quality Reporting Program
Requirements
To promote alignment of the HH QRP and the SNF QRP, IRF QRP, and
LTCH QRP regulatory text, we believe that with the exception of the
provision governing the 2 percentage point reduction to the update of
the unadjusted national standardized prospective payment rate, it is
appropriate to codify the requirements that apply to the HH QRP in a
single section of our regulations. Accordingly, in the CY 2020 HH PPS
proposed rule (84 FR 34684 through 34685), we proposed to amend 42 CFR
chapter IV, subchapter G, by creating a new Sec. 484.245, titled
``Home Health Quality Reporting Program''.
The provisions we proposed to codify were as follows:
The HH QRP participation requirements at Sec. 484.245(a)
(72 FR 49863).
The HH QRP data submission requirements at Sec.
484.245(b)(1), including--
++ Data on measures specified under section 1899B(c)(1) and
1899B(d)(1) of the Act;
++ Standardized patient assessment data required under section
1899B(b)(1) of the Act (82 FR 51735 through 51736); and
++ Quality data specified under section 1895(b)(3)(B)(v)(II) of the
Act including the HHCAHPS survey data submission requirements at Sec.
484.245(b)(1)(iii)(A) through (E) (redesignated from Sec. 484.250(b)
through (c)(3) and striking Sec. 484.250(a)(2)).
The HH QRP data submission form, manner, and timing
requirements at Sec. 484.245(b)(2).
The HH QRP exceptions and extension requirements at Sec.
484.245(c) (redesignated from Sec. 484.250(d)(1) through (d)(4)(ii)).
The HH QRP's reconsideration policy at Sec. 484.245(d)
(redesignated from Sec. 484.250(e)(1) through (4)).
The HH QRP appeals policy at Sec. 484.245(e)
(redesignated from Sec. 484.250(f)).
We also note the following codification proposals:
The addition of the HHCAHPS and HH QRP acronyms to the
definitions at Sec. 484.205.
The removal of the regulatory provision in Sec.
484.225(b) regarding the unadjusted national prospective 60-day episode
rate for HHAs that submit their quality data as specified by the
Secretary.
[[Page 60609]]
The redesignation of the regulatory provision in Sec.
484.225(c) to Sec. 484.225(b) regarding the unadjusted national
prospective 60-day episode rate for HHAs that do not submit their
quality data as specified by the Secretary.
The redesignation of the regulatory provision in Sec.
484.225(d) to Sec. 484.225(c) regarding the national, standardized
prospective 30-day payment amount. The cross-reference in newly
redesignated paragraph (c) would also be revised.
Comment: One commenter supported the proposed codification of the
HH QRP requirements.
Response: CMS appreciates the support from the commenter for the
codification of the HH QRP requirements.
Comment: One commenter did not support the codification of the HH
QRP requirements because of a concern that the current program favors
patients whose health status will improve, and does not adequately
consider patients whose status will just be maintained by home health
services. The commenter believes that codification of the current
requirements will reinforce the lack of attention given to appropriate
delivery of maintenance nursing and therapy services.
Response: We believe it is important to codify policies that apply
to the HHAs as it reflects the policies that apply to HHA's relative to
the HH QRP. We do not agree with the recommendation to not codify our
policies.
Final Decision: After careful consideration of the public comments
received, we are finalizing our proposal to codify requirements for the
HH QRP and note that we have made both a substantive change and
technical edits.
K. Home Health Care Consumer Assessment of Healthcare Providers and
Systems (CAHPS[supreg]) Survey (HHCAHPS)
In the CY 2020 HH PPS proposed rule (84 FR 34685), we proposed to
remove Question 10 from all HHCAHPS Surveys (both mail surveys and
telephone surveys) which says, ``In the last 2 months of care, did you
and a home health provider from this agency talk about pain?'' which is
one of seven questions (they are questions 3, 4, 5, 10, 12, 13 and 14)
in the ``Special Care Issues'' composite measure, beginning July 1,
2020. The ``Special Care Issues'' composite measure also focuses on
home health agency staff discussing home safety, the purpose of the
medications that are being taken, side effects of medications, and when
to take medications. In the initial development of the HHCAHPS Survey,
this question was included in the survey since home health agency staff
talk about pain to identify any emerging issues (for example, wounds
that are getting worse) every time they see their home health patients.
We proposed to remove the pain question from the HHCAHPS Survey and
pain items from the OASIS data sets to avoid potential unintended
consequences that may arise from their inclusion in CMS surveys and
datasets. The reason that CMS proposed removing this particular pain
question is consistent with the proposed removal of pain items from
OASIS in section IV.D.1. of this final rule with comment period and is
also consistent with the removal of pain items from the Hospital CAHPS
Survey. The removal of the pain question from CMS surveys and removal
of pain items from CMS data sets is to avoid potential unintended
consequences that arise from their inclusion in CMS surveys and
datasets. We welcomed comments about the proposed removal of Q10 from
the HHCAHPS Survey. In the initial development of the HHCAHPS Survey,
this question was included in the survey, and, consequently, from the
``Special Care Issues'' measure. The HHCAHPS Survey is available on the
official website for HHCAHPS, at https://homehealthcahps.org.
We solicited comment on this proposal. A discussion of the
comments, along with our responses, appears in this section of this
final rule with comment period.
Comment: We received a few comments supporting the removal of
Question 10. Commenters supporting the proposal to remove the pain
question either did not give a reason, or stated it would reduce
burden. Two commenters supported the question's removal due to the
unintended consequences of using pain killers.
Response: We thank the commenters for their support.
Comment: The majority of commenters opposed the removal of Question
10. There were a number of reasons that commenters opposed the proposal
to remove Q10 from the HHCAHPS survey and, consequently, from the
HHCAHPS Specific Care Issues measure. Some commenters stated that pain
assessment is a critical component of the home health care patient
assessment protocol and should be measured as part of a patient
experience of care survey. Several commenters contended that there is
no evidence that the discussion of pain is linked to opioid misuse.
Commenters wrote that home health providers are unable to prescribe
opioids and other medications so there would be no direct impact on
opioid prescribing. Some commenters said that because the presence of
pain is related to the ability to function, it is important to
determine if pain is causing a patient to have limited activity. Other
commenters noted that talking about pain is part of the physical
therapist's assessment of patients in home health care.
Some commenters thought that Question 10 provides an opportunity to
assess if home health agency staff are asking their patients about pain
to presumably follow-up with steps to address the patients' pain and
discomfort. An example is that a patient with diabetic complications
may not feel pain in their feet and by the time they feel pain in a
wound in their foot, it is likely that the wound's infection will be in
a critical state causing significant discomfort.
Response: We appreciate these comments and agree that monitoring
pain is critical in the home health setting to monitor how patients are
recovering and to identify emergent issues. Whether the question is on
the survey or not, we expect home health agencies to continue to
monitor pain in the home health setting.
Final Decision: Based upon the comments received, we have evaluated
our proposal to take into consideration points raised by commenters and
also concerns raised within HHS. Commenters noted that monitoring of
pain is critical and we agree that it is imperative to continue to
monitor the management of pain. HHS reviewers also noted that removal
of this question would potentially affect the validity of the survey
and we also agree with their concern. Therefore, we are not finalizing
our proposal to remove Question 10 from all HHCAHPS Surveys.
L. Form, Manner, and Timing of Data Submission Under the HH QRP
1. Background
Section 484.250 requires HHAs to submit OASIS data and Home Health
Care Consumer Assessment of Healthcare Providers and Systems Survey
(HHCAHPS) data to meet the quality reporting requirements of section
1895(b)(3)(B)(v) of the Act. Not all OASIS data described in Sec.
484.55(b) and (d) are necessary for purposes of complying with the
quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.
OASIS data items may be used for other purposes unrelated to the HH
QRP, including payment, survey and certification, the HH VBP Model, or
care planning. Any OASIS data that are not submitted for the purposes
of the
[[Page 60610]]
HH QRP are not used for purposes of determining HH QRP compliance.
2. Schedule for Reporting the Transfer of Health Information Quality
Measures Beginning With the CY 2022 HH QRP
As discussed in section V.E. of this final rule with comment
period, we are finalizing our proposal to adopt the Transfer of Health
Information to Provider-Post-Acute Care (PAC) and Transfer of Health
Information to Patient-Post-Acute Care (PAC) quality measures beginning
with the CY 2022 HH QRP. We are also finalizing our proposal that HHAs
would report the data on those measures using the OASIS. In addition,
we are also finalizing that HHAs would be required to collect data on
both measures for patients beginning with patients discharged or
transferred on or after January 1, 2021. HHAs would be required to
report these data for the CY 2022 HH QRP at discharge and transfer
between January 1, 2021 and June 30, 2021. Following the initial
reporting period for the CY 2022 HH QRP, subsequent years for the HH
QRP would be based on 12 months of such data reporting beginning with
July 1, 2021 through June 30, 2022 for the CY 2023 HH QRP.
3. Schedule for Reporting Standardized Patient Assessment Data Elements
Beginning With the CY 2022 HH QRP
As discussed in section V.G. of this final rule with comment
period, we finalized to adopt additional SPADEs beginning with the CY
2022 HH QRP. We finalized that HHAs would report the data using the
OASIS. HHAs would be required to collect the SPADEs for episodes
beginning or ending on or after January 1, 2021. We also finalized that
HHAs that submit the Hearing, Vision, Race, Ethnicity, Preferred
Language and Interpreter Services SPADEs with respect to SOC will be
deemed to have submitted those SPADEs with respect to SOC, ROC, and
discharge, because it is unlikely that the assessment of those SPADEs
with respect to SOC will differ from the assessment of the same SPADES
with respect to ROC or discharge. HHAs would be required to report the
remaining SPADES for the CY 2022 HH QRP at SOC, ROC, and discharge time
points between January 1, 2021 and June 30, 2021. Following the initial
reporting period for the CY 2022 HH QRP, subsequent years for the HH
QRP would be based on 12 months of such data reporting beginning with
July 1, 2021 through June 30, 2022 for the CY 2023 HH QRP.
4. Input Sought To Expand the Reporting of OASIS Data Used for the HH
QRP To Include Data on All Patients Regardless of Their Payer
We continue to believe that the reporting of all-payer data under
the HH QRP would add value to the program and provide a more accurate
representation of the quality provided by HHA's. In the CY 2018 HH PPS
final rule (82 FR 51736 through 51737), we received and responded to
comments sought for data reporting related to assessment based
measures, specifically on whether we should require quality data
reporting on all HH patients, regardless of payer, where feasible.
Several commenters supported data collection of all patients regardless
of payer but other commenters did express concerns about the burden
imposed on the HHAs as a result of OASIS reporting for all patients,
including healthcare professionals spending more time with
documentation and less time providing patient care, and the need to
increase staff hours or hire additional staff. A commenter requested
CMS provide additional explanation of what the benefit would be to
collecting OASIS data on all patients regardless of payer.
We are sensitive to the issue of burden associated with data
collection and acknowledge concerns about the additional burden
required to collect quality data on all patients. We are aware that
while some providers use a separate assessment for private payers, many
HHA's currently collect OASIS data on all patients regardless of payer
to assist with clinical and work flow implications associated with
maintaining two distinct assessments. We believe collecting OASIS data
on all patients regardless of payer will allow us to ensure data that
is representative of quality provided to all patients in the HHA
setting and therefore, allow us to better determine whether HH Medicare
beneficiaries receive the same quality of care that other patients
receive. We also believe it is the overall goal of the IMPACT Act to
standardize data and measures in the four PAC programs to permit
longitudinal analysis of the data. The absence of all payer data limits
CMS's ability to compare all patients receiving services in each PAC
setting, as was intended by the Act.
We plan to consider expanding the reporting of OASIS data used for
the HH QRP to include data on all patients, regardless of their payer,
in future rulemaking. Collecting data on all HHA patients, regardless
of their payer would align our data collection requirements under the
HH QRP with the data collection requirements currently adopted for the
Long-Term Care Hospital (LTCH) QRP and the Hospice QRP. Additionally,
collection of data on all patients, regardless of their payer was
proposed but not finalized in the FY 2020 rules for the Skilled Nursing
Facility (SNF) QRP (84 FR 17678 through 17679) and the Inpatient
Rehabilitation Facilities (IRF) QRP (84 FR 17326 through 17327). To
assist us regarding a future proposal, in the CY 2020 HH PPS proposed
rule (84 FR 34598), we sought input on the following questions related
to requiring quality data reporting on all HH patients, regardless of
payer:
Do you agree there is a need to collect OASIS data for the
HH QRP on all patients regardless of payer?
What percentage of your HHA's patients are you not
currently reporting OASIS data for the HH QRP?
Are there burden issues that need to be considered
specific to the reporting of OASIS data on all HH patients, regardless
of their payer?
What differences, if any, do you notice in patient mix or
in outcomes between those patients that you currently report OASIS
data, and those patients that you do not report data for the HH QRP?
Are there other factors that should be considered prior to
proposing to expand the reporting of OASIS data used for the HH QRP to
include data on all patients, regardless of their payer?
We did not propose to expand the reporting of OASIS data used for
the HH QRP to include data on all HHA patients regardless of payer. We
stated, however, that we welcomed comments on this topic, including
comments related to the questions noted previously, and that we would
take all recommendations received into consideration.
Comment: Several commenters supported expanding the reporting of
OASIS data used for the HH QRP to include data on all patients
regardless of their payer in the future. Commenters supporting all-
payer collection cited alignment with data collection requirements for
other PAC providers, as well as other quality programs, such as the
Merit-based Incentive Payment System. Other reasons cited by commenters
included more accurate representation of the quality of care furnished
by HHAs to the entire HH population, the ability of such data to better
guide quality improvement activities, and the reduction of current
administrative efforts made by HHAs to ensure that only OASIS data for
Medicare and Medicaid patients are reported to CMS. For example, one
large HHA noted that OASIS data are already completed for approximately
80 percent
[[Page 60611]]
of their patients. A state association commented that a survey of its
members found that 52 percent of respondents currently use the OASIS
assessment tool for all of their patients, regardless of payer, while
48 percent indicated that they do not.
Several commenters raised the need for explicit authorization to
submit data for other payers, and noted this could create additional
administrative burden if patient-level affirmation was required.
Commenters asked if agencies would need to develop a waiver or consent
for information release to be signed by patients covered by payers
other than Medicare in order to report their OASIS data to CMS. One
commenter recommended that CMS conduct a nationally-representative
survey to inform this decision.
The majority of commenters opposed expanding OASIS data reporting
to all-payers, most frequently noting the additional administrative
burden this would entail. A few commenters noted that the additional
data collection was not aligned with the Patients over Paperwork
initiative. One commenter specifically raised as an issue the burden of
training private-duty nurses on completing the OASIS. Even when data
are collected for all patients, some commenters noted that there would
be additional costs of submitting those data to CMS.
Several commenters also had concerns that the data collection could
implicate HIPAA and questioned how CMS would plan to use these data,
which is protected personal health information requested by a
government entity that is not the patient's payer. One commenter
requested that CMS provide the evidence-basis for expanding OASIS data
collection to all payers.
Several commenters noted there was no difference in care provided
to patients by payer type. Commenters stated that payer mix varies
considerably between agencies, with anywhere from 10 to 50 percent
patients being commercially-insured. One commenter noted over fifty
percent of their patients are Medicare patients, which they believed is
a sufficiently representative sample for quality reporting programs.
Several commenters described differences between commercially-
insured patients and Medicare patients, with commenters reporting that
commercially-insured patients are usually younger and healthier, and
recover more quickly. In addition to the differences in patient
demographics, commenters noted that coverage of services tends to
differ between Medicare and commercial insurance, and that some
commercial insurance providers restrict the number of home health
visits in ways that might alter the effectiveness of services for
patient outcomes. They also noted that commercial insurers do not have
a ``homebound'' requirement for patients and would not likely reimburse
the cost of OASIS data collection. Some commenters had concerns on how
these differences might adversely affect the quality results and
administrative burden.
Response: We appreciate all of the feedback that we received on
this issue and we will take it into consideration in our future policy
and propose it in future rulemaking whereby HHAs would be required to
collect and submit data on HH patients regardless of their payer.
VI. Medicare Coverage of Home Infusion Therapy Services
A. Background and Overview
1. Background
Section 5012 of the 21st Century Cures Act (``the Cures Act'')
(Pub. L. 114-255), which amended sections 1861(s)(2) and 1861(iii) of
the Act, established a new Medicare home infusion therapy benefit. The
Medicare home infusion therapy 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 drugs, furnished
by a qualified home infusion therapy supplier.
Section 50401 of the BBA of 2018 amended section 1834(u) of the Act
by adding a new paragraph (7) that establishes 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 same items and previously
listed 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
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 56046),
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.
2. 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.
Generally, Medicare payment under Part A 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
[[Page 60612]]
68210).\214\ Medicare also makes a separate payment to the physician or
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.
---------------------------------------------------------------------------
\214\ https://www.govinfo.gov/content/pkg/FR-2012-11-15/pdf/2012-26902.pdf.
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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
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.\215\ The MACs
review the Self-Administered Drug (SAD) exclusion lists on a regular
basis.\216\
---------------------------------------------------------------------------
\215\ 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.
\216\ Self-Administered Drug (SAD) Exclusion List Report.
www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx.
---------------------------------------------------------------------------
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 Bipartisan Budget Act (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 home infusion 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. Additionally,
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).
Only certain types of infusion pumps are covered under the DME
benefit. 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.\217\ 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.
---------------------------------------------------------------------------
\217\ Medicare National Coverage Determinations (NCD) Manual.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.html.
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3. Home Infusion Therapy Legislation
a. 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 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
[[Page 60613]]
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
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 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 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 other factors such as 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 HIT 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.
b. 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), 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 (L33794) 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 sub-regulatory guidance as a home infusion
drug.
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.
[[Page 60614]]
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 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.
4. Summary of CY 2019 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. 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 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),\218\
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. 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 \219\ outlining the requirements for the
claims processing changes needed to implement this payment.
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\218\ 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&.
\219\ 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.
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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 benefit to be implemented beginning in
CY 2021. Although we finalized this definition in regulation in the CY
2019 HH PPS final rule with comment period (83 FR 56583), we stated
that we would carefully monitor the effects of this definition on
access to care and that, if warranted and if within the limits of our
statutory authority, we would engage in additional rulemaking or
guidance regarding this definition. In that same rule, we solicited
additional comments on this interpretation and on its effects on access
to care.
B. CY 2020 Temporary Transitional Payment Rates for Home Infusion
Therapy Services
In the CY 2020 HH PPS proposed rule (84 FR 34689) we discussed
section 1834(u)(7) of the Act that established a home infusion therapy
services temporary transitional payment for eligible home infusion
suppliers for certain items and services furnished to administer home
infusion drugs. This temporary payment covers the cost of the
professional services, training and education, monitoring, and remote
monitoring 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
benefit on January 1, 2021, as required by section 5012 of the 21st
Century Cures Act. The list of transitional home infusion drugs and the
payment categories for the temporary transitional payment for home
infusion therapy services can be found in Tables 55 and 56 in the CY
[[Page 60615]]
2019 HH PPS proposed rule (83 FR 32465 and 32466).\220\
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\220\ CY 2019 HH PPS proposed rule (83 FR 32465 and 32466).
https://www.govinfo.gov/content/pkg/FR-2018-07-12/pdf/2018-14443.pdf.
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Section 1834(u)(7)(D)(i) of the Act sets the payment amounts for
each category 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 for such codes specified without application of
geographic adjustment under section 1848(e) of the Act. That is, the
payment amounts are based on the PFS rates for the Current Procedural
Terminology (CPT) codes corresponding to each payment category. For
eligible home infusion suppliers to bill for the temporary transitional
payments for home infusion therapy services for an infusion drug
administration calendar day, we created a G-code associated with each
of the three payment categories. The J-codes for eligible home infusion
drugs, the G-codes associated with each of the three payment
categories, and instructions for billing for the temporary transitional
home infusion therapy payments are found in the August 10, 2018 Change
Request 10836, ``Temporary Transitional Payment for Home Infusion
Therapy Services for CYs 2019 and 2020.'' \221\ Therefore, as proposed,
CMS will update the temporary transitional payment amounts based on the
CPT code payment amounts in the CY 2020 PFS final rule. At the time of
publication of this final rule with comment period, we do not yet have
the CY 2020 PFS final rates; however, in accordance with the CY 2020 HH
PPS proposed rule, the temporary transitional payments starting on
January 1, 2020 will be based on the PFS amounts as specified in
section 1834(u)(7)(D) of the Act. We will publish these updated rates
in the CY 2020 PFS final rule,\222\ and will publish the updated CY
2020 temporary transitional payment rates in the January 2020 DMEPOS
fee schedule file.\223\ We received a few comments on the proposed rule
regarding the CY 2020 temporary transitional payment rates for home
infusion therapy. The following are our responses:
---------------------------------------------------------------------------
\221\ CR 10836. 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.
\222\ Medicare Physician Fee Schedule. https://www.cms.gov/apps/physician-fee-schedule/.
\223\ January 2019 DMEPOS Fee Schedules. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule-Items/DME19-A.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending.
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Comment: A commenter stated that the lack of defined PFS rates
presents a hardship to suppliers when creating budgets for CY 2020.
This commenter also suggested that CMS include provisions for
geographic adjustments to the temporary transitional payment. The
commenter stated that geographic adjustment is necessary in light of
nursing shortages noted in several areas of our country, and stated
that the shortage of qualified professionals results in costs in
recruitment, retention, and wages, and requested that CMS consider
these challenges when reviewing the lack of geographic adjustment for
the temporary transitional payments.
Response: The proposed CY 2020 PFS rates for the infusion CPT codes
can be found at the following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-P.html. The final rates will be
posted in the CY 2020 PFS final rule, which we expect will be on
display by November 1, 2019. The temporary transitional rates for home
infusion therapy services will continue to be posted on the DMEPOS fee
schedule file, which can be found at the following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule.html. The CY 2020 rates as previously discussed,
will be posted by January 1, 2020.
Regarding geographic adjustment, the temporary transitional payment
is statutorily limited to the payment methodology as set forth in
section 1834(u)(7)(D) of the Act, which states that each payment
category is paid at amounts in accordance with the PFS for drugs
assigned to such category without geographic adjustment.
Comment: A commenter requested that CMS clarify that nurse
practitioners are authorized to establish the home infusion plan of
care during the temporary transitional period. The commenter expressed
understanding that, as the full payment provisions for the home
infusion benefit proposed in this year's rule do not go into effect
until CY 2021, there is no statutory requirement that only a physician
can establish the plan of care during the transitional payment period.
Response: In the Home Infusion Therapy Services Temporary
Transitional Payment Frequently Asked Questions (FAQs), we stated that
the eligibility criteria for home infusion therapy services includes
the patient being under a plan of care established and periodically
reviewed by a physician prescribing the type, amount, and duration of
infusion therapy services. The FAQs can be found at the following link:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Downloads/Home-Infusion-Therapy-Services-Temp-Transitional-Payment-FAQs.pdf. The BBA of 2018 gives CMS the authority
to implement requirements during the transitional payment period
outside of rulemaking. Therefore, we are maintaining our previously-
stated requirement that only the physician can establish and review the
plan during the transitional payment period.
C. 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 proposed rule (84
FR 34690), we proposed provisions regarding payment for home infusion
therapy services for CY 2021 and beyond 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.
We explained that 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, and that these provisions
serve as the basis for determining the scope of the home infusion drugs
eligible for coverage of home infusion therapy services; outline
beneficiary qualifications and plan of care requirements; and establish
who can bill for payment under the benefit.
Additionally, as previously discussed, in the CY 2019 HH PPS final
rule with comment period (83 FR 56583), we solicited additional
comments on our interpretation of the definition of ``infusion drug
administration calendar day'' and on its potential effects on access to
care. Although we did not propose a change to the definition, we
received comments on both the CY 2019 HH PPS final rule with comment
period and the CY 2020 HH PPS proposed rule with respect to our
interpretation.
Of the timely correspondence received in response to the CY 2020 HH
PPS proposed rule, approximately 52
[[Page 60616]]
comments pertained to the home infusion therapy benefit. The following
is a summary of the proposed rule provisions, comments received, and
our responses.
1. Infusion Drug Administration Calendar Day
In general, the comments received on the CY 2019 HH PPS final rule
with comment period and the CY 2020 HH PPS proposed rule regarding
``infusion drug administration calendar day'' were similar to those
received on the CY 2019 HH PPS proposed rule, and focused primarily on
the proposed definition as it pertains to the ``professional services''
covered under the benefit.
Comment: Commenters continued to disagree with the final definition
of ``infusion drug administration calendar day,'' and stated that
payment for home infusion therapy services should include any day that
a home infusion drug is infused, and not just a day on which a
professional is in the home furnishing services. Specifically,
commenters on the CY 2019 HH PPS final rule with comment period
recommended that CMS immediately amend the definition at 42 CFR 486.505
to eliminate the requirement that a skilled professional be in the home
in order for reimbursement to occur. The majority of the comments
pertaining to the home infusion benefit on the CY 2020 HH PPS proposed
rule reiterated this recommendation and called on CMS to revise the
existing definition of infusion drug administration calendar day to
allow for reimbursement of home infusion services ``each day that an
infusion drug physically enters the patient's body, irrespective of
whether a skilled professional is in the individual's home.''
Conversely, MedPAC continued to support CMS' definition of infusion
drug administration calendar day.
Response: As we stated in the CY 2019 HH PPS final rule with
comment period, the definition at 42 CFR 486.505 is consistent with
section 1861(iii)(1) of the Act, which defines the term ``home infusion
therapy'' as the items and services furnished by a qualified home
infusion supplier, which are furnished in the individual's home.
Additionally, 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. In
other words, section 1834(u)(7) makes clear that while the single
payment covers both professional services under section 1861(iii)(2)(A)
and training and education, remote monitoring, and other monitoring
services under section 1861(iii)(2)(B), payment is only issued on
certain days--days on which professional services are provided in the
patient's home.
Comment: Commenters stated that by not defining ``professional
services'' and limiting payment to a day on which a skilled
professional is in the home, CMS fails to capture a broader cross-
section of professional services that do not occur in the patient's
home, but that are critical to ensure the safe and effective provision
of home infusion therapy services. Several commenters specified that
these services include compounding and dispensing of the drug; however,
some commenters also identified ``remote pharmacy services'' that they
believe should be included in the payment. Commenters on the CY 2020 HH
PPS proposed rule elaborated on the notion of ``remote pharmacy
services,'' stating that these services include initial and ongoing
pharmacist assessments; clinical care planning; drug preparation and
compounding; care coordination; medication reconciliation; monitoring,
(including remote monitoring) for adverse events and response to
therapy; drug therapy evaluation and design; pharmacist interventions
and subsequent therapeutic recommendations to prescribers; patient
education; and all other associated professional work.
Response: The drugs identified for coverage of home infusion
therapy services are paid under the Part B DME benefit. Therefore, the
services related to the furnishing of the drug, remote or otherwise,
are paid under the DME benefit. Furthermore, a ``qualified home
infusion therapy supplier'' as defined in section 1861(iii)(3)(D)(i) of
the Act, is not required to furnish services related to the furnishing
of the drug. In the CY 2019 HH PPS final rule with comment period CMS
stated that we acknowledge that pharmacy services are closely related
to the home infusion therapy benefit; however, at this time pharmacy
services, furnished by a Medicare-enrolled DMEPOS supplier, associated
with the preparation and dispensing of home infusion drugs are covered
under the Part B DME benefit and are not part of the specific home
infusion therapy benefit (83 FR 56563).
In the CY 2019 HH PPS proposed rule (83 FR 32467) we stated that
the DME supplier standards require the DME supplier to document that it
or another qualified party has at an appropriate time provided
beneficiaries with the necessary information and instructions on how to
use Medicare-covered items safely and effectively.\224\ Therefore, the
professional services covered under the home infusion benefit would
include a limited amount of training and education on the provision of
home infusion drugs that is not already covered under the DME benefit
regarding the appropriate and safe use of the equipment.
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\224\ https://www.cms.gov/Medicare/wwwProvider-Enrollment-and-Certification/MedicareProviderSupEnroll/wwwdownloads/DMEPOSSupplierStandards.pdf.
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In accordance with section 1861(iii)(1)(B), an individual must be
under a plan of care established by a physician, prescribing the type,
amount, and duration of infusion therapy services, in coordination with
the furnishing of home infusion drugs. In order to avoid being overly
prescriptive, we did not define ``professional services'' or enumerate
a list of services that are covered under the benefit. We did not want
to inadvertently omit services which may be necessary for an individual
patient or particular therapy or course of treatment, as determined by
the physician responsible for the plan of care. As previously discussed
and in the CY 2019 proposed rule, the services provided under the home
infusion therapy benefit are distinct from those required and paid
under the DME benefit (that is, instruction on how to safely and
effectively use the DME equipment) and :
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
++ Teaching and training on flushing and locking the catheter
++ Dressing changes and site care
Patient assessment and evaluation:
++ Review of patient's history and assessment of current physical and
mental status, including obtaining vital signs
++ Assessment of any adverse effects or infusion complications
++ Evaluation of family and caregiver support
++ Review of prescribed treatment and any concurrent oral and/or over-
the-counter Treatments
++ Obtaining blood for lab-work
Medication and disease management education:
++ Instruction on self-monitoring
++ Education on lifestyle and nutritional modifications
[[Page 60617]]
++ 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:
++ Communicating with patient regarding changes in condition and
treatment plan
++ Monitoring patient response to therapy
++ Assessing compliance
Comment: A few commenters stated that Medicare's interpretation of
``infusion drug administration calendar day'' under the home infusion
therapy benefit is inadequate to cover the cost of care, and that
consequently, home infusion suppliers would be forced to discontinue
home infusion therapy services to Medicare beneficiaries. Some
commenters specifically identified subcutaneous immunoglobulin, stating
that administration of this biological requires virtually no
professional services in the home, and therefore the home infusion
supplier would never be reimbursed for the ``pharmacy-based'' services
furnished outside of the home. Commenters stated that this would impede
access to these services and force patients to receive their infusions
in the physician's office, outpatient department, hospital, or nursing
home, which are more costly and clinically less appropriate.
Response: The single payment for the home infusion therapy services
is only made when a skilled professional is in the patient's home on a
day of drug administration. This single payment does not include the
DME external infusion pump, supplies (including the home infusion
drug), and related services paid under the DME benefit. Medicare
payment for an infusion drug administration calendar day is separate
from the payment for DME items and services, therefore, a supplier
could still be paid for DME items and services under the DME benefit,
even if it does not receive payment for home infusion therapy services.
Additionally, the home infusion therapy services payment is a single
bundled payment amount, set equal to the administration services
furnished in a physician's office for each infusion drug administration
calendar day, regardless of the actual length of the visit. Therefore,
it is unclear why suppliers would limit access to patients requiring
``virtually no services in the home,'' when suppliers are still being
paid for the DME, supplies (including the home infusion drug), and
services covered under the DME benefit, as well as an additional
payment for professional services equal to a set amount of hours,
regardless of the actual visit length, when a home visit is furnished.
Comment: A commenter noted anecdotally that since the
implementation of the transitional benefit DME suppliers have begun to
consolidate or no longer accept new patients under the Part B benefit,
and anticipate that more beneficiaries will face access barriers.
Commenters requested that CMS make utilization data from 2019 available
for public review to allow for a full assessment of how the current
policy has impacted access and/or contributed to provider
consolidation.
Response: As we stated in the CY 2019 HH PPS final rule with
comment period, CMS will monitor home infusion therapy utilization to
determine what, if any, effects on access to care occur after
implementation of the temporary transitional payments for home infusion
therapy. Since the implementation of these payments on January 1, 2019
we have been collecting quarterly data on the number of home infusion
therapy users; volume of infusion therapy prescription fills, including
by category and individual drugs; and number of DME suppliers
furnishing home infusion therapy. We have been monitoring changes in
trends between quarters, nationwide trends, and trends across the
payment categories and among individual drugs, beneficiary
characteristics, and by geographic variation. We have also been
monitoring trend data from the past before the implementation of the
temporary transitional home infusion therapy payments. Based on the
claims data from Q1 2016 to Q4 2018, we found that overall, the
utilization of infusion services in Q4 2018 shows a steadily increasing
trend across all three care settings (home, outpatient, and physician's
office). Specifically, both the numbers of prescription fills and
claims for the transitional infusion drugs in the home setting
increased steadily in Q4 2018, compared to the previous quarter.
Additionally, although there has been fluctuation in the number of DME
suppliers supplying transitional home infusion drugs, from Q1 2016
through Q3 2018, the number has increased between Q3 and Q4, indicating
that access to services has not been negatively impacted since the drug
pricing change from average wholesale price (AWP) to average sales
price (ASP) plus 6 percent took effect on January 1, 2017. We will
continue to monitor and analyze claims data in order to determine
whether, and how access to home infusion therapy services has been
impacted since the implementation of the home infusion benefit in CY
2019. We are currently still receiving and analyzing claims data during
this time period; however, we note that home infusion utilization for
Q1 2019 has been stable and shown slight increases since Q1 2017. We
also note that this monitoring and analysis is unrelated to CMS's legal
interpretation of the term ``infusion drug administration calendar
day.'' We anticipate releasing our analysis of claims data from Q1 2016
through CY 2019 once we have more complete data for CY 2019.
2. 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 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 benefit to be a separate payment in addition
to the existing payment for the DME external infusion pump, supplies
(including the home infusion drug), and services covered under the DME
benefit. We stated that, consistent with the definition of ``home
infusion therapy,'' the home infusion therapy 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),\225\ 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 this LCD for External Infusion
Pumps. 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
[[Page 60618]]
therapy services will be covered beginning in CY 2021.
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\225\ Local Coverage Determination (LCD): External Infusion
Pumps (L33794). https://med.noridianmedicare.com/wwwdocuments/2230703/7218263/External+wwwInfusion+Pumps+LCD+and+PA.
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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. As noted in the
proposed rule, 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.
Therefore, 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.
Comment: A commenter requested clarification regarding the
applicability of payment for services under the home infusion benefit
specifically with regard to the administration of intravenous
immunoglobulin (IVIG). The commenter noted that we stated in the
proposed rule that payment category 1 would include any subsequent
intravenous infusion drug additions, and stated that a plain reading of
the statutory language indicates that IVIG products would meet the
definition of a home infusion drug administered intravenously and thus,
would be covered under the home infusion therapy payment beginning in
CY 2021. This commenter stated that the proposed codes for home
infusion therapy services payment categories, however, do not reflect
how IVIG services will be addressed. Similarly, another commenter
recommended including IV antibacterial drugs to the list of home
infusion drugs eligible for services beginning in CY 2021.
Response: As discussed in the CY 2020 HH PPS proposed rule (84 FR
34690), we stated that Medicare payment for home infusion therapy
services is for services furnished in coordination with the furnishing
of the intravenous and subcutaneous infusion drugs and biologicals
specified on the DME LCD for External Infusion Pumps (L33794), with the
exception of insulin pump systems and drugs and biologicals on a self-
administered drug exclusion list. In order for the drugs and
biologicals to be covered under the Part B DME benefit they must
require infusion through an external infusion pump. If the drug or
biological can be infused through a disposable pump or by a gravity
drip, it does not meet this criterion. IVIG does not require an
external infusion pump for administration purposes and therefore, would
not be covered under the DME LCD for External Infusion Pumps. We note
that a DME external infusion pump is also not covered under the
Medicare Intravenous Immune Globulin Demonstration. The Frequently
Asked Questions (FAQs) regarding this demonstration state that it is up
the supplier to determine the services and supplies appropriate and
necessary to administer the IVIG in any given situation, and that this
may or may not include the use of a pump.\226\ Furthermore, the LCD
specifically states that intravenous immune globulin products are not
covered under this LCD and specifies that DME coverage of subcutaneous
immune globulin (SCIG) applies only to those products that are
specifically labeled as subcutaneous administration products. This
means that immune globulin labeled for both intravenous and
subcutaneous use would not be covered under the LCD.
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\226\ https://innovation.cms.gov/wwwinitiatives/IVIG/supplierfaq.html.
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The reference to payment category 1 including any subsequent
intravenous drug or biological additions is in reference to the DME LCD
for External Infusion Pumps (L33794). In the CY 2020 HH PPS proposed
rule (84 FR 34687) we stated that the DME Medicare Administrative
Contractors (MACs) specify the details of which infusion drugs are
covered with these pumps through local coverage policies. We also gave
examples of covered Part B DME infusion drugs, which we stated
currently include, among others, certain IV drugs for heart failure and
pulmonary arterial hypertension; immune globulin for primary immune
deficiency (PID); insulin; antifungals and antivirals; and
chemotherapy, in limited circumstances. As previously discussed, the
immune globulin for PID currently covered under the DME LCD for
External Infusion Pumps (L33794) is only immune globulin which is
administered subcutaneously, not intravenously, and is paid under
payment category 2 of the temporary transitional home infusion therapy
services payment. If the MACs determine that additional intravenous
infusion drugs or biologicals (excluding chemotherapy drugs or other
highly complex drugs and biologicals, as those would be paid under
payment category 3) meet the criteria to be added to the DME LCD for
External Infusion Pumps (L33794), then home infusion therapy services
for these newly added intravenous drugs would be covered under payment
category 1. Likewise, although there are a few antifungal and antiviral
drugs covered under the DME LCD for External Infusion Pumps (L33794),
there are currently no antibacterial drugs included and therefore,
services for these drugs would not be covered under the home infusion
therapy benefit at this time. In general, antibiotics do not require
the use of a DME external infusion pump and can be given through an
elastomeric pump or by gravity infusion.
Comment: Commenters requested coverage of home infusion therapy
services for other drugs and biologicals currently covered under the
DME LCD for External Infusion Pumps (L33794). A commenter recommended
we cover services for Carbidopa 5 Mg/Levodopa 20 Mg enteral suspension
and Hizentra, a subcutaneous immunoglobulin. The commenter noted that
the pump and supplies for Carbidopa/Levodopa are billed to DME, similar
to immune globulin, and recommended services be covered under payment
category 2. Regarding Hizentra, the commenter urged CMS to either
extend coverage for services under the home infusion benefit in CY 2021
or remove Hizentra from the self-administered drug exclusion list. Also
with regard to the self-administered drug exclusion lists, another
commenter encouraged CMS to consider giving additional guidance to the
MACs regarding the process and time involved in administering SCIG
therapies. Lastly, a commenter recommended identifying all such drugs
administered via external infusion pumps covered under the DME benefit
as ``home infusion drugs.''
Response: As noted previously, section 1861(iii)(3)(C) of the Act
defines a ``home infusion drug'' as a parenteral drug or biological
administered intravenously or subcutaneously. Although we clarified
that a ``home infusion drug'' is a drug or biological included on the
DME LCD for External Infusion Pumps (L33794), there are drugs and
biologicals on this LCD that do not meet the definition of ``home
infusion drug'' required by statute. While Carbidopa/Levodopa is on the
DME LCD, because it is an enteral infusion and not administered
intravenously or subcutaneously, it does not meet the statutory
definition of
[[Page 60619]]
home infusion drug. Additionally, in the CY 2020 HH PPS proposed rule,
we identified additional drugs covered under the temporary transitional
payment that would be excluded from the permanent benefit because they,
similarly, do not meet the statutory definition of home infusion drug.
We stated that Ziconotide and Floxuridine are not considered ``home
infusion drugs'' because they are not administered either
subcutaneously or intravenously (84 FR 34695). Section 1861(iii)(3)(C)
of the Act also excludes insulin pump systems and any drugs or
biologicals on self-administered drug exclusion lists from the
definition of home infusion drug. Therefore, this provision excludes
Hizentra, which is on a self-administered drug exclusion list, from the
benefit beginning in CY 2021. Because this is a statutory exclusion,
CMS does not have the authority to extend coverage under the home
infusion benefit for services related to drugs and biologicals on these
lists. In the CY 2020 HH PPS proposed rule we discuss that the
determination for which drugs and biologicals belong on a self-
administered drug exclusion list is made on a drug by drug basis,
taking into account whether a drug is self-administered by more than 50
percent of Medicare beneficiaries (84 FR 34687). Chapter 15, section
50.2 of the Medicare Benefit Policy Manual \227\ addresses the specific
policy for making this determination in general, therefore, further
guidance to the MACs regarding specific therapies is unnecessary.
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\227\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
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Comment: Many commenters expressed concern that relying on the DME
LCD for External Infusion Pumps limits the ability for new and/or
innovative drugs to be added under the home infusion therapy benefit.
Commenters indicated that the LCD process and the DME criteria is such
that the DME MACs continue to evaluate drugs based on the notion that
only drugs that patients can self-administer, or that a caregiver can
administer for the patient, can be added. Commenters recommended that
CMS require the DME MACs to increase transparency of their coverage
policy by further detailing the criteria used to make coverage
determinations and ensuring that coverage determinations follow current
clinical practice guidelines and patient need. Another commenter urged
CMS to clarify that Medicare covers the cost of pump maintenance for
the duration of the drug's use in treating the beneficiary and further
clarify that pumps supplied per the benefit remain the property of the
pharmacy and are returnable when the beneficiary ceases service.
Response: As detailed in section VI.C.1.a. of the CY 2020 HH PPS
proposed rule, home infusion drugs are those drugs and biologicals
identified on the DME LCD for External Infusion Pumps (L33794). This
does not however, limit the scope of drugs to only those drugs and
biologicals which are currently on this LCD at this time. Table 30
lists the drugs and biologicals which are currently on the DME LCD for
External Infusion Pumps (L33794), and which also meet the definition of
a home infusion drug; however, it is important to note that this list
is not static. The DME criteria used to determine which items are
included on the LCD for External Infusion Pumps, as well as the cost of
pump maintenance, is out of the scope of this final rule with comment
period, which focuses on the home infusion therapy benefit. However, in
response to stakeholder concerns regarding the limitations of the DME
LCDs for External Infusion Pumps that preclude coverage to certain
infused drugs, we are soliciting comments on the criteria CMS could
consider to allow coverage of additional drugs under the DME benefit.
With regard to transparency in the LCD Development Process, the
21st Century Cures Act required a summary of the evidence and a
publication of a written explanation of the rationale to be included in
the LCD. The new LCD development process that includes these procedures
is outlined in Chapter 13 of the Medicare Program Integrity Manual
(PIM); pub. 100-08 (found at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html) and went
into effect on January 1, 2019. Therefore, the new LCD development
requirements do not apply to local coverage policies prior to the
effective date of January 1, 2019.
In addition, the mechanism that allows the Medicare Administrative
Contractors (MACs) to change coverage continues to be the LCD
reconsideration process. The LCD reconsideration process allows any
stakeholder to submit new evidence to ask for a reconsideration of the
policy. The full LCD reconsideration process and requirements are also
located at Chapter 13 of the PIM. We encourage stakeholders with
additional evidence to engage their MAC in consultation regarding the
available evidence that was not considered in the initial review, or to
sensitize the MAC of emerging evidence that could be useful in an
upcoming reconsideration once published.
3. 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, we proposed to make a number
of revisions to the regulations to implement the home infusion therapy
services payment system beginning on January 1, 2021. We proposed to
add a new 42 CFR part 414, subpart P, to implement the home infusion
therapy services conditions for payment. In accordance with the
standards at Sec. 486.520, we proposed conforming regulations text, at
Sec. 414.1505, requiring that home infusion therapy services be
furnished to an eligible beneficiary by, or under arrangement with, a
qualified home infusion therapy supplier that meets the health and
safety standards for qualified home infusion therapy suppliers at Sec.
486.520(a) through (c). We also proposed at Sec. 414.1510 that, as a
condition for payment, qualified home infusion therapy suppliers must
ensure that a beneficiary meets certain eligibility criteria for
coverage of services, as well as ensure that certain plan of care
requirements are met. We proposed at Sec. 414.1510 to require that a
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. Additionally, we proposed at
Sec. 414.1510, to require that a beneficiary must be under a plan of
care, established by a physician. In accordance with section
1861(iii)(1)(B) of the Act, a physician is defined at section
1861(r)(1) of the Act, as a doctor of medicine or osteopathy legally
authorized to practice medicine and surgery by the State in which he
performs such function or action. We proposed to require at Sec.
414.1515, that
[[Page 60620]]
the plan of care must contain those items listed in Sec. 486.520(b).
We also stated that in addition to the type of home infusion therapy
services to be furnished, the physician's orders for services in the
plan of care must also specify at what frequency the services will be
furnished, as well as the healthcare professional that will furnish
each of the ordered services. The following is a summary of the
comments received on the proposed conditions for payment, which include
patient eligibility and plan of care requirements, and our responses.
Comment: A commenter stated that proposed Sec. 414.1515(c) does
not provide applicable providers the authority to properly manage home
infusion patients under their care. The commenter noted that while the
statute says that a physician is required to establish and periodically
review the plan of care, the patient can be under the care of an
applicable provider, which does not have to be a physician. Commenters
disagreed with the portion of proposed Sec. 414.1515(c) which states
that a physician must sign and date the plan of care upon any changes
to the plan of care, and stated that this is not required by statute
and prevents an applicable provider from managing a patient under his/
her care when the applicable provider is not the ordering physician.
This commenter requested that CMS remove this language from proposed
Sec. 414.1515 or amend the language to state that the ``ordering
physician or applicable provider must sign and date the plan of care
upon any changes to the plan of care.''
Response: We appreciate the commenter's review of the regulatory
language and recognition that in accordance with section
1861(iii)(1)(A) of the Act, the patient must be under the care of an
applicable provider, which as defined in 1861(iii)(3)(A) of the Act, is
a physician, nurse practitioner, or physician assistant. Additionally,
section 1861(iii)(1)(B) of the Act, states that the beneficiary must be
under a plan of care, established by a physician (defined at section
1861(r)(1) of the Act). Therefore, for payment purposes, the plan of
care must be established and reviewed by a physician. This means that
all services billed to Medicare have to be reflected in the plan of
care, which is required to be established and reviewed by the
physician, which includes any changes or updates to the plan, as stated
in the regulatory language. We will consider whether an applicable
provider can update the plan of care for future rulemaking.
Comment: Several commenters recommended that CMS adopt a timeframe
for the physician review of the plan of care. Some commenters
specifically recommended that CMS require the physician to review the
plan of care at least every 90 days.
Response: As section 1861(iii)(1)(B) of the Act states that the
plan of care must be periodically reviewed by a physician in
coordination with the furnishing of home infusion drugs, we believe
this to mean that the home infusion plan of care must be established
and reviewed by the physician, in consultation with the DME supplier
responsible for furnishing the home infusion drugs. Additionally, the
DME Quality Standards require suppliers to work collaboratively with
the physician prescribing the drug, who is ultimately responsible for
any changes in type, dosage, and frequency of medication. Therefore, as
coordination is required between the entity responsible for furnishing
the drug, and both the entities (if they are not the same entity)
responsible for ordering the home infusion therapy services and the
home infusion drug, we would expect all entities to be involved in the
care coordination process.
However, we do recognize the integral part the plan of care plays
in care coordination between providers, particularly when the physician
ordering the home infusion drug is not the same physician establishing
the home infusion therapy plan of care. Coordination between the
physician ordering the home infusion drug, the physician ordering the
home infusion services, and the DME supplier furnishing the home
infusion drug is imperative in providing safe and effective home
infusion therapy. Coordination would likely include review of the
patient assessment and evaluation, including interpretation of lab
results as they pertain to changes in medication type, dose, or
frequency. And, as many of the home infusion drugs and biologicals
likely require weekly bloodwork and close monitoring, a current home
infusion therapy plan of care is essential in order to ensure that the
qualified home infusion therapy supplier is providing the appropriate
professional services, including patient monitoring, to ensure that
administration is safe and effective. Additionally, these drugs and
biologicals treat a variety of both acute and chronic conditions.
Treatment regimens and schedules will likely vary in length and
intensity depending on the drug, individual response to therapy, and
disease progression. As such, patient needs, including interventions
and monitoring, will likely fluctuate based on short-term and long-term
goals of the varying treatment regimens. For this reason, in order to
ensure that therapy is safe and effective throughout the course of
treatment, the physician responsible for the home infusion therapy plan
of care should review the plan on a regular basis, in coordination with
the DME supplier.
We received comments on the proposed health and safety standards in
the CY 2019 HH PPS proposed rule stating that establishing timeframe
requirements could conflict with State laws, creating duplicative
requirements, which may add burden to home infusion therapy suppliers.
Therefore, we stated in the CY 2019 HH PPS final rule with comment
period that we would not include specific timeframes for the review of
the plan of care, and will defer to existing State laws and regulations
(83 FR 56563). However, we will take the recommendations received on
the CY 2020 HH PPS proposed rule regarding establishing a timeframe for
physician review under consideration for future rulemaking.
Comment: Several commenters recommended that CMS require that home
infusion suppliers document the following in the plan of care: Drug
name, strength, and dosage; frequency of administration; route of
administration; method of administration; and a care plan for the
following professional services: Patient assessments; drug therapy
evaluation and design; drug preparation and compounding; care
coordination; monitoring and remote monitoring; and nursing services.
Response: The CY 2019 HH PPS final rule with comment period
finalized the plan of care requirements for home infusion therapy
suppliers. Section 486.520(b) requires that the home infusion therapy
supplier ensure that all patients have a plan of care established by a
physician that prescribes the type, amount, and duration of home
infusion therapy services that are to be furnished. The plan of care
would also include the specific medication, including the prescribed
dosage and frequency, as well as the professional services to be
utilized for treatment. In addition, the plan of care would specify the
care and services necessary to meet the patient-specific needs (83 FR
56562). Additionally, proposed Sec. 414.1515 requires, as a condition
for payment, that in addition to the elements indicated in Sec.
486.520(b), the physician's orders for services in the plan of care
must also specify at what frequency the services will be furnished, as
well as the healthcare professional that will furnish each of the
ordered services. These required elements
[[Page 60621]]
capture the majority of the commenters' recommendations; however, any
additional regulatory plan of care elements would be required to go
through notice and comment rulemaking.
Comment: Several commenters recommended that CMS add a requirement
that the same physician be responsible for signing the DME detailed
written order (DWO) and the home infusion therapy plan of care.
Commenters stated that because CMS is proposing to allow the DME
supplier and the home infusion therapy supplier to be different
entities, there is a risk for medication errors resulting from
conflicting orders being obtained by the individual providers involved
in the patient's care.
Response: We recognize the commenter's concern; however, the
statute does not specify that the home infusion plan of care must be
established by the same physician who orders the DME and signs the DWO.
While we would expect that in most cases the physician ordering the
home infusion therapy services is the same physician ordering the DME
and the infusion drug, we recognize that this may not always be the
case. However, Sec. 486.520(a) requires that in addition to the
professional services utilized for treatment, the home infusion plan of
care must include the specific home infusion drug or biological, along
with the prescribed dosage and frequency of the medication. Therefore,
regardless of whether the physician ordering the home infusion drug is
the same physician ordering the home infusion therapy services, there
must be care coordination between both entities in order to meet the
plan of care requirements under Sec. 486.520(a).
Comment: A commenter noted that in the CY 2019 HH PPS final rule
with comment period, CMS finalized the definition of ``applicable
provider'' at Sec. 486.505 as ``a physician, a nurse practitioner, and
a physician assistant;'' however, the regulatory language under 42 CFR
486.505 uses the term ``nurse provider'' rather than ``nurse
practitioner.'' The commenter therefore, requested a technical edit of
42 CFR 486.505 to change the language to read ``nurse practitioner'' in
accordance with the statutory definition at 1861(iii)(3)(A) of the Act.
Response: We thank the commenter for his/her review of the
regulatory language and agree that the language at Sec. 486.505 should
be changed from ``nurse provider'' to ``nurse practitioner'' and will
be modified accordingly.
Final Decision: We are finalizing, as proposed, the home infusion
therapy services conditions for payment at 42 CFR part 414, subpart P.
In addition, in response to the comment made regarding terminology,
we will amend the regulations at Sec. 486.505 to change the term
``nurse provider'' to ``nurse practitioner.'' We are also amending
Sec. 414.1550(a)(1) and (2) to include ``or service.'' Although these
changes were not proposed in the proposed rule, we are adopting the
changes here under a ``good cause'' waiver of proposed rulemaking. The
specific changes we are making in the regulations are simply technical
corrections in the language and do not reflect any additional
substantive changes. Therefore, we find that undertaking further notice
and comment procedures to incorporate these corrections into this final
rule with comment period is unnecessary and contrary to the public
interest.
4. 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. Importantly, neither the statute, nor
the health and safety standards and accreditation requirements,
outlined in 42 CFR part 486, require the qualified home infusion
therapy supplier to furnish the pump, home infusion drug, or related
pharmacy services. Therefore, in the CY 2020 HH PPS proposed rule, 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 statute. 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.
Comment: A commenter supported CMS' efforts to promote supplier
participation in Medicare home infusion therapy services and improve
access for beneficiaries by giving them more choices of providers under
the benefit.
Response: We thank the commenter for this recognition and also
anticipate that the breadth of providers able to become accredited as
qualified home infusion therapy suppliers will help ensure continued
access to home infusion services.
Comment: A commenter referenced the discussion of billing for
chronic care management and remote patient monitoring codes associated
with the home infusion benefit. The commenter indicated that CMS only
references ordering physicians and does not mention applicable
providers, and stated that CMS should clarify that these codes, and
other care coordination services, are billable by the applicable
provider managing the patient's care. Another commenter suggested
adding teaching and training users to self-administer using a pump,
troubleshooting pump issues (for example, telephonically or via video
monitoring); and providing clinical/quality assessments such as
monitoring the efficacy of drugs (for example, number of infections for
a user of immune globulin diagnosed with primary immunodeficiency
(PID)) to the proposed list of remote monitoring services.
Response: The discussion referencing the PFS chronic care
management and remote monitoring codes was regarding the services for
which a provider can bill separately under the PFS and was referenced
in order to separate these services from the care coordination included
in the bundled services under the single unit of payment for home
[[Page 60622]]
infusion therapy suppliers. These are not codes for which home infusion
therapy suppliers can bill separately under the home infusion therapy
benefit, therefore, which providers can bill for these codes is out of
the scope of the CY 2020 HH PPS final rule with comment period.
Additionally, as we did not propose a list of remote monitoring
services considered professional services under the home infusion
therapy benefit, it is unclear if the comment regarding teaching and
training on the pump pertains specifically to the CY 2020 HH PPS
proposed rule. However, we will note that the commenter's suggestion
that the infusion therapy supplier engage in training and education on
the item of DME, address services already covered under the DME
benefit, and would not be covered under the home infusion therapy
benefit. Additionally, in the CY 2019 HH PPS proposed rule, although we
did not define home infusion therapy professional services, we did give
examples of services we believe fall under the home infusion therapy
benefit. Clinical assessments, including monitoring efficacy of drug
therapy, was included in these examples (83 FR 32468).
Comment: Several commenters expressed concern about care
coordination between different entities providing services under
various benefits. These commenters stated that the proposed rule tasked
the home infusion therapy supplier with furnishing the necessary
services to administer the drug in the home, but does not require the
qualified home infusion therapy supplier to furnish the pump, home
infusion drug, or related pharmacy services. Commenters stated that
because ``CMS' interpretation'' allows the DME supplier and the home
infusion therapy supplier to be separate entities, this could
potentially create confusion about roles and responsibilities. Further,
commenters indicated that CMS makes no requirement for the provider of
HIT services to coordinate directly with the DME supplier. A commenter
stated that typically, commercial payers structure the home infusion
benefit as a pharmacy-coordinated service, where the pharmacy assumes
responsibility for case managing the therapy and provides oversight of
all the professional services. The commenter noted that under the
commercial payer structure, the pharmacy is the entity contracted to
supply the drugs, equipment, and supplies, and because of the
dependency between these two components of care, commercial payers and
accreditation organizations never separate the case management from the
supplier of the drug, equipment, and supplies. Commenters recommended
that the Secretary add a new requirement that the home infusion therapy
supplier be enrolled in the DME program as a pharmacy that provides
external infusion pumps and supplies, and that maintains all pharmacy
licensure and accreditation requirements, and that all components of
the home infusion benefit should be billed by the same provider,
including professional services, drugs, pumps, and supplies.
Response: We recognize that there may be various providers and
suppliers involved in a patient's care in the provision of home
infusion therapy and the importance of care coordination. While the
supplier furnishing the DME, home infusion drug, and related services
may be the supplier furnishing the home infusion services, the statute
does not require that the DME supplier also furnish home infusion
therapy 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. There is no provision requiring the home
infusion therapy supplier to furnish the infusion pump, drug, or other
supplies. Further, section 1861(iii)(3)(D)(ii) of the Act allows a
qualified home infusion therapy supplier to sub-contract with a
pharmacy, physician, provider of services, or supplier to provide these
services. Additionally, section 1861(u) of the Act defines ``provider
of services'' to mean a hospital, critical access hospital, skilled
nursing facility, comprehensive outpatient rehabilitation facility,
home health agency, hospice program, or, for purposes of sections
1814(g) and 1835(e) of the Act, a fund. Therefore, any of the
previously noted entities who meet the Medicare accreditation
requirements for home infusion therapy suppliers is eligible to enroll
as a qualified home infusion therapy supplier.
We also do not anticipate a lapse in care coordination in the case
that the home infusion therapy supplier is not the same entity
furnishing the DME, drug, and related services. Section 1861(iii)(1)(B)
of the Act states that the home infusion therapy plan of care must be
established and periodically reviewed by a physician in coordination
with the furnishing of home infusion drugs. As previously stated, this
means that the home infusion plan of care must be established and
reviewed by a physician in consultation with the DME supplier
responsible for furnishing the home infusion drug and related services.
Likewise, as discussed in the CY 2020 HH PPS proposed rule, the DME
Quality Standards require the supplier (furnishing the infusion drug)
to consult with the physician prescribing the infusion drug as needed
to confirm the order and to recommend any necessary changes,
refinements, or additional evaluation to the prescribed equipment
item(s), and/or service(s) (84 FR 34692). Therefore, as the DME
supplier is required to consult with the physician prescribing the
infusion drug, initially and upon any changes in medication or orders,
and the physician responsible for drafting the home infusion plan of
care is required to consult with the DME supplier and the home infusion
therapy supplier, we would expect the home infusion therapy plan of
care to be current. Furthermore, proposed Sec. 414.1515 requires that
the home infusion plan of care contain the items indicated in Sec.
486.520(b), which includes the specific medication, the prescribed
dosage and frequency, as well as the professional services to be
utilized for treatment, including the care and services necessary to
meet patient-specific needs. Additionally, proposed Sec. 414.1515
requires the plan of care to include the healthcare professional that
will furnish each of the ordered services. Therefore, while the home
infusion therapy supplier may not be the DME supplier, the home
infusion plan of care must contain the required contents, as previously
discussed, and established in coordination with the furnishing of the
infusion drug. For this reason, in order to ensure that therapy is safe
and effective throughout the course of treatment, as required by
section 1861(iii)(1)(B) of the Act, the physician who orders the home
infusion therapy services must review the plan of care on a regular
basis, in coordination with the DME supplier, who is also required to
consult with the physician prescribing the infusion drug.
Comment: A commenter requested that CMS clarify whether there will
be a grace period for accreditation, and whether or not more
accrediting bodies be added.
Response: Home Infusion Therapy (HIT) Accreditation Organizations
will be held to the same expectations as our remaining accreditation
organizations. The home infusion therapy application procedures and
ongoing responsibilities are provided at 42 CFR part 488, subpart L.
Any accreditation organization will be allowed to apply to be a CMS
Approved Deeming Accreditation Organization for Home Infusion
[[Page 60623]]
Therapy, if the organization meets all of the requirements provided at
42 CFR 488.1010. Applications will be considered for the January 1,
2021 designation deadline, if the application is received by April 1,
2020.
Comment: Several commenters indicated that reimbursement under the
DME benefit is inadequate to cover the home infusion therapy
professional services and stated that Congress understood that the
breadth and frequency of these services exceeds the scope of the DME
benefit. Other commenters stated that the home infusion therapy payment
was intended to make up for the drug pricing change from AWP to ASP
plus 6 percent. Commenters stated that it is for these reasons that
Congress created the home infusion therapy benefit and intended for
these services, most notably those provided remotely by a pharmacist,
to be reimbursed without regard to overlap with the DME benefit or
contingent on the patient's nursing needs. Additionally, commenters
stated that it is notable that Congress exempted training and education
that is not otherwise paid for as DME from the professional services
reimbursement, but made no such exemption for professional services,
remote monitoring and monitoring services, or the other professional
services referenced in the proposed rule.
Response: We are unsure of whether Congressional intent for the
home infusion benefit was to reimburse providers for the change in drug
pricing. However, in general, Medicare does not implement new benefits
in order to subsidize other existing benefits. Additionally, because
the home infusion therapy services payment does not include payment for
the DME or the home infusion drug, the adequacy of the drug pricing is
out of the scope for this final rule with comment period. Although the
commenter stated that the home infusion therapy payment is for services
``without regard to overlap with DME,'' it is important to note that
Medicare does not make duplicative payment for services, therefore we
would not require two benefits to furnish the same services.
Additionally, CMS did not define or enumerate the professional
services under the home infusion therapy benefit in order to avoid
inadvertently excluding certain services. However, we agree that it is
notable that training and education not otherwise paid for as DME is
exempted from the professional services covered under the home infusion
therapy benefit. The training and education provided under the DME
benefit are services that would likely be furnished in the patient's
home. Therefore, in order to avoid making duplicative payment, the
training and education furnished under the DME benefit is explicitly
excluded from the home infusion therapy services payment. 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.
5. Home Infusion Therapy and the Interaction With Home Health
In the proposed rule, we discussed the potential for overlap
between the new home infusion therapy benefit and the home health
benefit. We stated that a beneficiary is not required to be considered
homebound in order to be eligible for the home infusion therapy
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, we stated that 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 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 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 claim under
the home infusion therapy 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
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 bill for the
services related to the administration of the home infusion drugs on
the home infusion therapy services claim.
Comment: Several commenters expressed concern that home health
agencies will not be able to bill for the home infusion therapy
services for beneficiaries under a home health plan of care, unless
they are also accredited as a home infusion therapy supplier.
Commenters expressed concern that this is in contrast to the full
coverage currently available for beneficiaries under the home health
benefit, and that beneficiaries will now be responsible for a 20
percent coinsurance. Additionally, commenters stated that the home
health agency would be responsible for providing the pump, medication,
and infusion supplies if they did obtain the designation, and expressed
concern that many HHAs believe that this is outside of their scope of
practice. Commenters stated that HHAs will restrict the availability of
infusion services and limit those patients needing infusion services,
forcing many of these patients to receive their infusions at another
setting rather than receiving them at home. A commenter recommended
that the home infusion benefit should only be available for
beneficiaries who are not homebound, and infusion services for
otherwise eligible home health beneficiaries should remain under the
home health benefit.
Response: We understand commenter concern regarding home infusion
therapy services under the home health benefit; however, section 5012
of the 21st Century Cures Act amends section
[[Page 60624]]
1861(m) of the Act to exclude home infusion therapy from home health
services effective January 1, 2021. Therefore, home infusion therapy
will no longer be provided to homebound patients under the home health
benefit. Home infusion therapy services will now be provided under the
home infusion benefit for both homebound and non-homebound
beneficiaries. It is also important to note, that the HHA is not
responsible for furnishing the pump, related supplies, or the infusion
medication. Further, the HHA is already required to arrange for the DME
and related infusion services for patients under a home health plan of
care. In the case that an HHA also becomes accredited as a home
infusion therapy supplier, the HHA would continue to meet the
requirements under the Home Health Conditions of Participation (CoPs)
as well as the home infusion therapy supplier requirements as set out
in Part 486, Subpart I, of which DME services, including pharmacy
services associated with the preparation and dispensing of home
infusion drugs are not included. We acknowledged in the CY 2019 HH PPS
final rule with comment period that while these services are closely
related to the home infusion therapy benefit, they remain covered under
the Part B DME benefit and are not part of the Medicare home infusion
therapy benefit (83 FR 56563).
6. Public Comments Regarding 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 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 treatment options. For example, a physician may
verbally discuss the treatment options with the patient during the
visit and annotate the treatment decision in the medical record before
establishing the infusion plan. Some physicians may also provide
options in writing to the patient in the hospital discharge papers or
office visit summaries, as well as retain a written patient attestation
that all options were provided and considered. The frequency of
discussing these options could vary based on a routine scheduled visit
or according to the individual's clinical needs.
We solicited comments in the CY 2020 PFS proposed rule (84 FR
40716), as well as 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 solicited comments
on any additional interpretations of this notification requirement and
whether this requirement is already being met under the temporary
transitional payment for home infusion therapy services.
The following is a summary of the related comments received on both
solicitations.
Comment: Several commenters supported the proposed examples of the
physician verbally discussing the infusion therapy options and
annotating the resulting decision in the medical record and initial
plan of care. Many commenters stated that written materials may be a
helpful supplement to a verbal conversation, but written materials
should not be the sole means of beneficiary notification. They
emphasized that infusion therapy options should be verbally discussed
so the patient, and any family caregiver, may have an opportunity to
get immediate answers to questions that may not be addressed in written
materials. Many commenters encouraged CMS to consider minimizing the
paperwork burden and confusion that written documents or patient
attestations could impose on physicians and patients.
Commenters recommended that the conversation should include how the
infusion therapy options differ in terms of effectiveness, safety,
time, comfort, convenience, location, frequency, and out-of-pocket
costs. Some commenters specifically noted that beneficiaries are
subject to the standard 20 percent coinsurance with this new Part B
benefit; and the ordering physician should be aware of the patient's
insurance status and therefore assist them in making informed decisions
about their care.
Some commenters recommended the policy should allow for other
professionals, such as social workers, home health nurses, and other
staff to assist the treating physician with this notification in order
to remove unnecessary administrative burden for clinicians. Commenters
also requested that the notification policy include requirements would
be simple and easy for physicians to implement, and that would retain
the current flexibility for physicians to use multiple notification
mechanisms as directly suggested by beneficiaries, advocates and
stakeholders.
One commenter requested that CMS follow similar procedures for
other electronically prompted beneficiary notifications. Another
commenter recommended that CMS develop a single standardized format for
this notice to avoid benefit denials and delays in therapy. Another
commenter suggested that CMS establish a training program for
physicians, hospitals and contractors prior to implementation.
A commenter requested that CMS permit sufficient time for
physicians to research the available home infusion therapy options.
Another commenter requested that CMS create a web page where a
beneficiary or referring clinician can research if there is a home
infusion therapy supplier in the beneficiary's geographic location that
is capable of delivering these services, and that the supplier is
enrolled and approved by Medicare.
A few commenters asked that this notification be required only when
the drug regimen is available and appropriate for home infusion
therapy. They suggested that notification should not be required if
there are certain safety risks associated with infusion therapy in that
patient's home or if the home infusion therapy option is not available
in the patient's geographic area.
Regarding the frequency of notification, one commenter suggested
that only one streamlined notice be required at the start of therapy
because many therapies have a duration for the life of the beneficiary.
Two commenters specified that notification of options should be
discussed and documented in the patient record whenever a new infusion
therapy treatment is deemed necessary by the physician and anytime
thereafter if there are changes in patient condition or circumstances
that would affect the patient's choices.
Response: We appreciate the commenters' support and recommendations
and will take the comments into consideration as we continue developing
future policy through notice-and-comment rulemaking effective for home
infusion therapy services beginning CY 2021 and for subsequent years.
[[Page 60625]]
D. Payment Categories and Amounts for Home Infusion Therapy Services
for CY 2021
In the CY 2020 HH PPS proposed rule we discussed section
1834(u)(1)(A)(i) of the Act, which requires the Secretary 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. Section 1834(u)(1)(B)(ii) of the Act requires the payment
amount to reflect patient acuity and complexity of drug administration.
We stated 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. We proposed to maintain the
three payment categories, with the associated J-codes, utilized
currently under the temporary transitional payment. We stated that this
utilizes an already established framework for assigning a unit of
single payment (per category), accounting for different therapy types,
which in turn, reflects variations in nursing utilization, complexity
of drug administration, and patient acuity. We stated that retaining
the three current payment categories would maintain consistency with
the already established payment methodology and ensure a smooth
transition between the temporary transitional payments and the
permanent payment system to be implemented beginning with CY 2021.
Table 30 provides the list of J-codes associated with the infusion
drugs that fall within each of the payment categories. We also noted
that there are a few drugs for which services are included under the
transitional benefit that would not be defined as home infusion drugs
under the permanent benefit beginning with CY 2021.
BILLING CODE 4120-01-P
[[Page 60626]]
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BILLING CODE 4120-01-C
We stated in the proposed rule that the language at section
1834(u)(1)(A)(ii) of the Act is consistent with section
1834(u)(7)(B)(iv) of the Act, which establishes ``single payment
amounts'' for the temporary transitional payments for home infusion
therapy services. We also reiterated that a ``single payment amount''
for an infusion drug administration calendar day means that all home
infusion therapy services, which include professional services,
including nursing; training and education; remote monitoring; and
monitoring, are built into the day on which the services are furnished
in the home and the drug is being administered. In other words, payment
for an infusion drug administration calendar day is a bundled payment
amount per visit. As such, because payment for an infusion drug
administration calendar day under the permanent benefit is also a
``unit of single payment,'' we proposed to carry forward the payment
methodology as outlined in section 1834(u)(7)(A) of the Act for the
temporary transitional payments. We proposed to pay a single payment
amount for each infusion drug administration calendar day in the
individual's home for drugs assigned under each proposed payment
category. Each proposed payment category amount would be in accordance
with the six infusion CPT codes identified in section 1834(u)(7)(D) of
the Act. However, because section 1834(u)(1)(A)(iii) of the Act states
that the single payment shall not exceed more than 5 hours of infusion
for a particular therapy in a calendar day, we proposed that the single
payment amount be set at an amount equal to 5 hours of infusion therapy
administration services in a physician's office for each infusion drug
administration calendar day, rather than retaining the current rate
under the temporary transitional payment, equal to 4 hours. We stated
that a single unit of payment equal to 5 hours of infusion therapy
services in a physician's office is a reasonable approach to account
for the bundled services included under the home infusion therapy
benefit. We
[[Page 60627]]
stated that setting the payment amount at the maximum amount allowed by
statute would reflect the varying degrees of care among individual
patients within each category and from visit to visit for the same
patient. It would also ensure that payment for home infusion therapy
services adequately covers the different patient care needs and level
of complexity of services provided, while remaining a unit of single
payment. While the single unit of payment for the temporary
transitional payments was set at 4 hours by law, the law for the
permanent benefit provides more latitude for home infusion therapy
services payments beginning in CY 2021. We stated that furnishing care
in the patient's home is fundamentally different from furnishing care
in the physician's office due to healthcare professionals being unable
to achieve the economies of scale in the home that can be achieved in
an office setting. Therefore, the single unit of payment is a bundle
that is made on the basis of expected costs for clinically-defined
episodes of care, where some episodes of care for similar patients with
similar care needs cost more than others. While the payment rates for
each of the three payment categories are higher than the home health
per-visit nursing rate of $149.68, the rate for medical social services
is $239.92. As we did not limit this benefit to only nursing visits,
the home infusion therapy rates for subsequent visits are comparable to
the home health per visit amounts. The home infusion therapy rates
reflect the increased complexity of the professional services provided
per category, and as required by law. We continue to believe that
increasing the payment amount to 5 hours will better account for all of
the home infusion therapy services covered under the benefit, including
nursing; training and education; remote monitoring; and monitoring
provided on an infusion drug administration calendar day.
We also stated that setting the payment amounts for each proposed
payment category in accordance with the CPT infusion code amounts under
the PFS accounts for variation in utilization of nursing services,
patient acuity, and complexity of drug administration. Medicare PFS
valuation of CPT codes uses a combination of the time and complexity
used to furnish the service, as well as the amount and value of
resources used. We explained that one component used to value the CPT
code, the non-facility practice expense relative value unit (RVU), is
based, in part, on the amount and complexity of services furnished by
nursing and ancillary clinical staff involved in the procedure or
service, and that therefore, the values of the CPT infusion code
amounts, in accordance with the different payment categories, reflect
variations in nursing utilization, patient acuity, and complexity of
drug administration, as they are directly proportionate to the clinical
labor involved in furnishing the infusion services in the patient's
home.
We also recognized that often the first visit furnished by a home
infusion therapy supplier to furnish services in the patient's home may
be longer or more resource intensive than subsequent visits. In
accordance with section 1834(u)(1)(C) of the Act, which allows the
Secretary discretion to adjust the single payment amount to reflect
outlier situations and other factors as the Secretary determines
appropriate, in a budget neutral manner, we proposed increasing the
payment amounts for each of the three payment categories for the first
visit by the relative payment for a new patient rate over an existing
patient rate using the physician evaluation and management (E/M)
payment amounts for a given year. Overall this adjustment would be
budget-neutral, in accordance with the requirement at section
1834(u)(1)(C)(ii) of the Act, resulting in a small decrease to the
payment amounts for any subsequent visits. We stated that the first
visit payment amount is only issued on the first home visit to initiate
home infusion therapy services furnished by the qualified home infusion
therapy supplier, and that any changes in the plan of care or drug
regimen, including the addition of drugs or biologicals that may change
the payment category, would not trigger a first visit payment amount.
We stated that if a patient receiving home infusion therapy services is
discharged, the home infusion therapy services claim must show a
patient status code to indicate a discharge with a gap of more than 60
days in order to bill a first visit again if the patient is readmitted.
This means that upon re-admission, there cannot be a G-code billed for
this patient in the past 60 days, and the last G-code billed for this
patient must show that the patient had been discharged. A qualified
home infusion therapy supplier could bill the first visit payment
amount on day 61 for a patient who had previously been discharged from
service. We also recognized that many beneficiaries have been receiving
services during the temporary transitional payment period, and as a
result, many of these patients already have a working knowledge of
their pump and may need less start-up time with the nurse during their
initial week of visits during the permanent benefit. Therefore, we
stated that suppliers would not be able to bill for the initial visit
amount for those patients who have been receiving services under the
temporary transitional payment, and have billed a G-code within the
past 60 days.
And finally, we stated that 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.
The following is a summary of the comments received on the proposed
CY 2021 home infusion therapy categories and payment amounts, and our
responses:
Comment: A few commenters' stated that the proposed categories do
not necessarily reflect the acuity or complexity of drug
administration. These commenters did not suggest other methods for
grouping drugs but recommended that CMS reimburse all home infusion
professional services at the proposed rate for payment category 3 (1
hour at CPT 96413 and 4 hours at CPT 96415). MedPAC recommended that
CMS use 2019 home infusion therapy claims data to evaluate the three
categories and consider whether modifications to the three categories
are appropriate in next year's proposed rule.
Response: While commenters' did not provide a rationale as to why
they believe all infusion drug administration calendar days should be
paid at the payment category 3 rate, it is important to reiterate that
CMS is required to account for varying therapy types under the payment
system. Section 1834(u) of the Act requires the Secretary to implement
a payment system under which a single payment is made to a home
infusion therapy supplier for the items and services (professional
services, including nursing services; training and education; remote
monitoring, and other monitoring services), beginning January 1, 2021.
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.
Paying a single payment amount at the category 3 rate for the
professional services for all home infusion drugs
[[Page 60628]]
would not take into account types of infusion therapy, including the
variation in utilization of nursing services, patient acuity, and
complexity of drug administration.
We appreciate MedPAC's suggestion to evaluate the three categories
and consider whether modifications are appropriate for next year's
rule. We will continue to monitor home infusion utilization using the
temporary transitional payment claims data, including visit length. If
adjustments to any of the home infusion therapy provisions are
warranted based on this data analysis, we will address such changes in
future rulemaking.
Comment: A commenter stated that the CPT description for the
category three CPT codes are more expansive than only chemotherapy
drugs, and noted that it can be used for ``injection and intravenous
infusion chemotherapy and other highly complex drug or highly complex
biologic agent administration.''
Response: We recognize that the CPT code associated with payment
category 3 home infusion drugs also includes other highly complex drugs
and biologicals; however, currently the only drugs on the LCD for
External Infusion Pumps (L33794) that are appropriate for this category
are the cancer chemotherapy drugs. In the event that additional drugs
or biologicals are added to the DME LCD, then potentially more drugs
and biologicals (other than cancer chemotherapy drugs) would be
included in payment category 3.
Comment: The majority of commenters supported the 5 hour payment
rate; however, these commenters continued to disagree with the
definition of ``infusion drug administration calendar day.'' Several
commenters also stated they would support retaining the three payment
categories and the rates that were established in the Bipartisan Budget
Act of 2018 if CMS were to pay on each day the patient receives an
infusion drug, regardless of whether a professional is in the home.
MedPAC disagreed with the increase from a 4 hour payment rate to a 5
hour payment rate without sufficient evidence that this increase is
warranted, or that increasing the aggregate level of payment to the
maximum level permitted by statute is an appropriate approach for
addressing variation in costs across patients. MedPAC also suggested
considering other approaches to address variation in costs such as
developing a payment adjuster for patient acuity or complexity of drug
administration.
Response: We thank the commenters for their support for setting the
payment rate to 5 hours of infusion in a physician's office. We believe
that a single unit of payment equal to 5 hours of infusion therapy
services in a physician's office is a reasonable approach to account
for the bundled services included under the home infusion therapy
benefit. We understand MedPAC's concern regarding the lack of evidence
that such an increase in the number of hours is warranted. However,
because the home infusion therapy payment must take into account, as
appropriate, types of infusion therapy, including variations in
utilization of services by therapy type, yet remain a single payment
amount, we do believe that setting the payment rate to the maximum
amount set in statute recognizes the variety and amount of services
included in the payment. Also, because we are implementing a payment
system for a new Medicare benefit, we do not have sufficient data in
order to examine situations for which payment adjustment (for example,
a case-mix adjustment system) may be appropriate. As previously
discussed, we plan to continue to monitor visit length in order to
determine if adjustments in the payment methodology are needed.
However, as we do not collect cost report data for suppliers, it is
unclear how we would be able to evaluate data regarding variations in
cost across patients.
We remind commenters that we finalized the definition of ``infusion
drug administration calendar day'' in the CY 2019 HH PPS final rule
with comment period (83 FR 56583) and we did not propose changes to
this definition in the CY 2020 HH PPS proposed rule. Our responses to
additional comments received on the CY 2019 HH PPS final rule with
comment period with regard to this definition are addressed in section
VI.C.1. of this final rule with comment period. Therefore, payment for
home infusion therapy services beginning in CY 2021 will be for those
days on which a skilled professional is in the patient's home
furnishing home infusion therapy services during a day of drug
administration.
Comment: Commenters were overwhelmingly in support of the proposed
payment adjustment for the first visit. Commenters appreciated the
recognition that new patients require more time and education. A
commenter agreed that it is reasonable to expect that the first home
infusion therapy visit will have higher associated costs, but
encouraged CMS to examine claims data as it becomes available in order
to determine an appropriate payment rate for the first versus
subsequent visits.
Response: We thank commenters for their support of this proposal,
and as previously stated, do plan on monitoring visit lengths in order
to determine if the data substantiates this adjustment.
Comment: A few commenters recommended collecting the data necessary
to construct a permanent rate that reflects the complexity and duration
of services necessary to deliver home infusion therapy, will
incentivize the delivery of safe, effective, high-quality care, and
will inform future policy discussions as new and emerging medications
become available.
Response: We appreciate commenters' recommendations and will
consider them for the future as well as continue to monitor home
infusion therapy utilization through the collection and analysis of
claims data as previously discussed.
Final Decision: We are finalizing our proposal to maintain the
three payment categories currently being utilized under the temporary
transitional payments for home infusion therapy services. We are
finalizing that each category payment amount will be in accordance with
the six CPT infusion codes under the PFS and equal to 5 hours of
infusion services in a physician's office. And finally, we are
finalizing our proposal to increase the payment amounts for each of the
three payment categories for the first visit by the relative payment
for a new patient rate over an existing patient rate using the
physician evaluation and management (E/M) payment amounts for a given
year, in a budget neutral manner, resulting in a small decrease to the
payment amounts for any subsequent visits. Payment will be made for
each infusion drug administration calendar day in accordance with the
definition finalized in the CY 2019 final rule with comment period (83
FR 56583). We will continue to evaluate the home infusion therapy
benefit and if appropriate and within the scope of our statutory
authority, make adjustments to the payment methodology to maximize
utilization of the home infusion therapy benefit, while protecting the
integrity of the Medicare program.
In response to stakeholder concerns regarding the limitations of
the DME LCDs for external infusion pumps that preclude coverage to
certain infused drugs, we seek comments on the criteria CMS could
consider to allow coverage of additional drugs under the DME benefit.
In order for a drug to be covered as a supply under the Medicare DME
benefit, the drug itself must require administration through an
external infusion pump. Under this benefit, the DME Supplier Standards
require that
[[Page 60629]]
the supplier train the patient and/or caregiver to operate the
equipment safely and effectively in the home. As such, the patient and/
or caregiver must be able to use the equipment on his/her own. For this
reason, the DME LCDs for External Infusion Pumps do not currently
include drugs that the patient and/or caregiver would not be able to
infuse in the home without a healthcare professional present. However,
given the new permanent home infusion therapy benefit to be implemented
beginning January 1, 2021, which includes payment for professional
services, including nursing; we are soliciting comments on options to
enhance future efforts to improve policies related to coverage of
eligible drugs for home infusion therapy (for example, whether coverage
could include instances where diseases or conditions prevent a patient
from being able to self-infuse, such as due to a neurodegenerative
disease). We believe that any changes to the DME and home infusion
therapy benefits must first ensure that the DME and supplies covered
fall within the scope of the DME benefit, and also balance concerns of
promoting access to innovative treatments with patient safety and cost-
efficient delivery and monitoring of drug infusions relative to the
facility setting (for example, physician office or hospital outpatient
department).
Table 31 shows the payment categories with the CPT codes and units
for such codes for home infusion therapy services in CY 2021 and
subsequent calendar years. Table 32 illustrates the 5-hour payment
rates (using the proposed CY 2020 PFS amounts) reflecting the increased
payment for the first visit and the decreased payment for all
subsequent visits. The actual home infusion payment rates will be
updated in next year's rule using the CY 2021 PFS amounts.
[GRAPHIC] [TIFF OMITTED] TR08NO19.048
[GRAPHIC] [TIFF OMITTED] TR08NO19.049
E. Required Payment Adjustments for CY 2021 Home Infusion Therapy
Services
1. 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 2019 HH PPS proposed rule (83 FR
32467) we stated that we were considering using the Geographic Practice
Cost Indices (GPCIs) to account for regional variations in wages and
adjust the payment for home infusion therapy professional services;
however, after further analysis and consideration we stated that we
determined that the geographic adjustment factor (GAF) is a more
appropriate option to adjust home infusion therapy payments based on
differences in geographic area 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).\228\ The work GPCI reflects the relative costs of
physician labor by region. The PE GPCI measures the
[[Page 60630]]
relative cost difference in the mix of goods and services comprising
practice expenses among the PFS localities as compared to the national
average of these costs. The MP GPCI measures the relative regional cost
differences in the purchase of professional liability insurance (PLI).
The GAF is updated at least every 3 years per statute and reflects a
1.5 work GPCI floor for services furnished in Alaska as well as a 1.0
PE GPCI floor for services furnished in frontier states (Montana,
Nevada, North Dakota, South Dakota and Wyoming).
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:
---------------------------------------------------------------------------
\228\ GAF = (.50886 x Work GPCI) + (.44839 x PE GPCI) + (.04295
x MP GPCI).
[GRAPHIC] [TIFF OMITTED] TR08NO19.050
We would apply the appropriate GAF value to the home infusion
therapy single payment amount based on the site of service of the
beneficiary. There are currently 112 total PFS localities, 34 of which
are statewide areas (that is, only one locality for the entire state).
There are 10 states with 2 localities, 2 states having 3 localities, 1
state having 4 localities, and 3 states having 5 or more localities.
The combined District of Columbia, Maryland, and Virginia suburbs;
Puerto Rico; and the Virgin Islands are the remaining three localities.
Beginning in 2017, California's locality structure was modified to
increase its number of localities from 9, under the previous locality
structure, to 27 under the new Metropolitan Statistical Area based
locality structure defined by the Office of Management and Budget
(OMB).
The list of GAFs by locality for this final rule with comment
period is available as a downloadable file at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html.
We considered other alternatives to using the GAF such as the
hospital wage index (HWI), the GPCI, and using just the practice
expense component of the GPCI. However, we proposed use of the GAF to
geographically wage adjust home infusion therapy for CY 2021 and
subsequent years. We stated that the GAF is the best option for
geographic wage adjustment, as it is the most operationally feasible.
Utilizing the GAF would allow adjustments to be made while leveraging
systems that are already in place. There are already mechanisms in
place to geographically adjust using the GAF and applying this option
would require less system changes. The adjustment would happen on the
PFS and be based on the beneficiary zip code submitted on the 837P/CMS-
1500 professional and supplier claims form. The GAF is further
discussed in the CY 2017 PFS final rule (81 FR 80170). The final CY
2020 and CY 2021 GAF values for each payment locality, when available,
will be posted along with the final rule with comment period at:
https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-
Center.html.
We proposed that the application of the geographic wage adjustment
be budget neutral so there is no overall cost impact. However, this
results 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 0.9985. The budget
neutrality factor will be recalculated for 2021 in next year's rule
using 2019 utilization data from the first year of the temporary
transitional payment period.
We received a comment that supported the use of geographic
adjustment for the home infusion therapy benefit in CY 2021; however,
we did not receive any comments specifically regarding the use of the
GAF, or any other wage adjustment, to geographically adjust the home
infusion therapy payment amounts.
Comment: A commenter stated support for the use of geographic
payment indexing to ensure that in higher cost markets, reimbursement
is in line with expenses.
Response: We appreciate the commenter's support, and will note that
geographic adjustment is a statutory requirement for the home infusion
therapy benefit beginning in CY 2021.
Final Decision: We are finalizing our proposal to use the GAF to
geographically adjust the home infusion therapy payment amounts in CY
2021 and subsequent calendar years.
2. 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
stated that 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.
F. Other Optional Payment Adjustments/Prior Authorization for CY 2021
Home Infusion Therapy Services
1. Prior Authorization
Section 1834(u)(4) of the Act allows the Secretary discretion, as
appropriate, to apply prior authorization for home infusion therapy
services. Generally, prior authorization requires that a decision by a
health insurer or plan be rendered to confirm health care service,
treatment plan, prescription drug, or durable medical equipment is
medically necessary.\229\ Prior authorization helps to ensure that a
service, such as home infusion therapy, is being provided
appropriately.
---------------------------------------------------------------------------
\229\ Preauthorization. https://www.healthcare.gov/glossary/preauthorization/.
---------------------------------------------------------------------------
In the CY 2020 HH PPS proposed rule (84 FR 34701), we discussed
comments received on the CY 2019 HH PPS proposed rule solicitation of
comments regarding whether and how prior authorization could
potentially be applied under the home infusion benefit. We noted that
the majority of commenters were concerned that applying prior
authorization would risk denying or delaying timely access to needed
services, as an expeditious transition of care is clinically and
economically important in home infusion therapy.
Ultimately, we agreed with commenters and stated that we do not
consider prior authorization to be appropriate for the home infusion
therapy benefit at this time, as the benefit is contingent on the
requirement that a home infusion drug or biological be administered
through a Medicare Part B covered pump that is an item of DME. We
stated that we will monitor
[[Page 60631]]
the provision of home infusion therapy services and revisit the need
for prior authorization if issues arise.
We received a few comments on the CY 2020 HH PPS proposed rule
regarding the use of prior authorization for the home infusion therapy
benefit in CY 2021:
Comment: A commenter stated that requiring prior authorization from
the prescriber for home infusion therapy services will not improve the
safety or efficacy of care, as site of care choices in this context are
only initiated by the prescribing physician. The commenter stated that
the home infusion therapy supplier cannot unilaterally switch the care
setting, and stated that further mandating prior authorization only
delays initiation of home infusion therapy for the patient and adds
administrative burden and costs to the process. Another commenter
stated that implementing prior authorization for home infusion therapy,
or any other home health service would be a duplication of physician
effort (who have already determined reasonable and necessary), may
result in delay of care, and potentially lead to a prior denial for
legitimate care.
Response: We thank the commenters for their comments. As stated
previously, we agree that prior authorization is not necessary for home
infusion therapy at this time, but will continue to monitor the
provision of home infusion therapy services and revisit the need for
prior authorization if issues arise.
2. Payments for High-Cost Outliers for Home Infusion Therapy Services
Section 1834(u)(1)(C) of the Act allows for discretionary
adjustments which may include outlier situations and other factors as
the Secretary determines appropriate. In the 2020 HH PPS proposed rule
(84 FR 34701) we discussed comments received on the CY 2019 HH PPS
proposed rule, regarding situations that may incur an outlier payment
and potential designs for an outlier payment calculation. We stated
that we planned to monitor the need for such payment and if necessary
address outlier situations in future rule making. We received a comment
regarding outliers for home infusion therapy services.
Comment: MedPAC suggested that although it may be premature to
develop a system of outliers, developing such a system would be
preferable to increasing aggregate payments for the purpose of
addressing cost variation.
Response: We thank MedPAC for this recommendation and will pay
close attention to any situations that would potentially be appropriate
for an outlier payment, and if necessary address these situations in
future rulemaking.
G. Billing Procedures for CY 2021 Home Infusion Therapy Services
Finally, in the CY 2020 HH PPS proposed rule we discussed billing
procedures for home infusion therapy services for CY 2021 and
subsequent years. We stated that because a qualified home infusion
therapy supplier is only required to enroll in Medicare as a Part B
supplier, and is not required to enroll as a DME supplier, it is more
practicable to process home infusion therapy service claims through the
A/B MACs and the Multi-Carrier System (MCS) for Medicare Part B claims.
DME suppliers, also enrolled as qualified home infusion therapy
suppliers, would continue to submit DME claims through the DME MACs;
however, they would also be required to submit home infusion therapy
service claims to the A/B MACs for processing. Therefore, the qualified
home infusion therapy supplier will submit all home infusion therapy
service claims on the 837P/CMS-1500 professional and supplier claims
form to the A/B MACs. DME suppliers, concurrently enrolled as qualified
home infusion therapy suppliers, would need to submit one claim for the
DME, supplies, and drug on the 837P/CMS-1500 professional and supplier
claims form to the DME MAC and a separate 837P/CMS-1500 professional
and supplier claims form for the home infusion therapy professional
services to the A/B MAC. We stated that because the home infusion
therapy services are contingent upon a home infusion drug J-code being
billed, home infusion therapy suppliers must ensure that the
appropriate drug associated with the visit is billed with the visit or
no more than 30 days prior to the visit. We also plan to add the home
infusion G-codes to the PFS, incorporating the required annual and
geographic wage adjustments. Home infusion therapy suppliers will
include a modifier on the appropriate G-code to differentiate the first
visit from all subsequent visits, as well as a modifier to indicate
when a patient has been discharged from service. We will issue a Change
Request (CR) providing more detailed instruction regarding billing and
policy information for home infusion therapy services, prior to
implementation of the CY 2021 home infusion benefit.
Comment: Several commenters had concerns about the home infusion
therapy supplier enrollment process with the A/B MACs, as the majority
of suppliers are only enrolled as DME suppliers and only bill the DME
MACs. They stated that the 855B A/B enrollment form does not include a
category for ``home infusion therapy supplier'' and urged CMS to offer
enrollment guidance. Commenters also pointed out that the DME supplier
is not required to be in the same state as the patient, which allows
the supplier to distribute drugs and supplies across a broad
geographical region, thereby allowing continued service for Medicare
beneficiaries who spend parts of the year in different states. They
encouraged CMS to ensure that home infusion therapy suppliers are able
to enroll in such a way that they can identify their pharmacy as a
practice location and base-operation from which they schedule and
dispatch nursing related home infusion services; allow for
jurisdictional enrollment and billing of HIT services without the
requirement to have a physical location within the jurisdiction; and
allow for DME suppliers, also accredited as qualified home infusion
therapy suppliers, to complete a single A/B MAC application identifying
all areas that they schedule and dispatch the nursing component of home
infusion therapy.
Response: We thank commenters for their review of the billing
procedures outlined in the proposed rule. We recognize that the
enrollment process will be new for the DME suppliers enrolling
concurrently as home infusion therapy suppliers; however, we encourage
commenters not to conflate DME suppliers with home infusion therapy
suppliers. The DME taxonomy code, which, as the commenter pointed out,
allows for pharmacy-based, decentralized patient care that does not
require a physical brick-and mortar location, will not be affected by
the requirement for home infusion therapy suppliers enrollment through
the A/B MACs. DME suppliers are not required to enroll with the A/B
MACs but instead they will continue to enroll with the National
Supplier Clearinghouse, and their billing processes for equipment and
supplies, including infusion drugs, will not change. Only if they
become accredited as a home infusion therapy supplier, would they
complete an additional enrollment with the A/B MACs in order to submit
home infusion therapy service claims. We do understand that some
current DME suppliers enrolling as home infusion therapy suppliers may
not have brick-and-mortar locations per the A/B MAC requirements;
however, and plan to issue more complete guidance for these providers.
We also recognize there is currently not a ``home infusion therapy
supplier'' type on the 855B enrollment form, and
[[Page 60632]]
are considering creating one for home infusion supplier enrollment. In
the meantime, providers can enroll using the ``other'' option. We are
currently examining and working on all other aspects of the enrollment
process and appreciate and will take all commenter suggestions under
consideration as we continue developing guidance for suppliers.
VII. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment before the provisions of a
rule take effect in accordance with section 553(b) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can
waive this notice and comment procedure if the Secretary finds, for
good cause, that the notice and comment process is impracticable,
unnecessary, or contrary to the public interest, and incorporates a
statement of the finding and the reasons therefore in the rule. This
home health proposed rule has previously been subjected to notice and
comment procedures. These corrections do not make substantive changes
to this policy. Specifically, we amended the definition of ``applicable
provider'' at Sec. 486.505 to read ``nurse practitioner'' rather than
``nurse provider.'' Additionally, we amended Sec. 414.1550(a)(1) and
(2) to include ``or service''. The specific changes we are making in
the regulations are simply technical corrections in the language and do
not reflect any additional substantive changes. Therefore, we find that
undertaking further notice and comment procedures to incorporate these
corrections into the CY 2020 final rule with comment period is
unnecessary and contrary to the public interest.
Additionally, we are finalizing the submission of a ``no-pay'' RAP
within five calendar days after the start of each 30-day period of care
for CY 2021. We are also finalizing to apply a payment reduction if the
``no-pay'' RAP is not submitted timely. These changes were not proposed
in the proposed rule, however, we are adopting the change here under a
``good cause'' waiver of proposed rulemaking. The specific changes we
are making are in accordance with the proposed NOA policy for CY 2021.
However, we are delaying the submission of a NOA until CY 2022 to allow
sufficient time to make system changes to accommodate the NOA process.
We note that if the NOA policy would have been finalized for CY 2021,
the payment reduction for an untimely filed NOA would also be applied.
Therefore, finalizing a ``no-pay'' RAP policy, as opposed to a NOA
policy, with an untimely submission payment reduction in CY 2021 does
not reflect any additional substantive changes to what was proposed.
Therefore, we find that undertaking further notice and comment
procedures to incorporate this correction into the final rule with
comment period is unnecessary and contrary to the public interest.
VIII. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. 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.
In section V. of this final rule with comment period, we are
finalizing our proposed updates to the HH QRP with the exception of the
removal of Question 10 from all HHCAHPS survey as discussed in Section
V.K. We believe that the burden associated with the HH QRP provisions
is the time and effort associated with data collection and reporting.
As of February 1, 2019, there are approximately 11,385 HHAs reporting
quality data to CMS under the HH QRP. For the purposes of calculating
the costs associated with the collection of information requirements,
we obtained mean hourly wages for these staff from the U.S. Bureau of
Labor Statistics' May 2018 National Occupational Employment and Wage
Estimates (https://www.bls.gov/oes/current/oes_nat.htm). To account for
overhead and fringe benefits (100 percent), we have doubled the hourly
wage. These amounts are detailed in Table 33.
[GRAPHIC] [TIFF OMITTED] TR08NO19.051
As discussed in section V.D. of this final rule with comment
period, we are finalizing the removal of the Improvement in Pain
Interfering with Activity Measure (NQF #0177) from the HH QRP beginning
with the CY 2022 HH QRP under our measure removal Factor 7: Collection
or public reporting of a measure leads to negative unintended
consequences other than patient harm. Additionally, we finalized the
removal of OASIS item M1242. Removing M1242 will result in a decrease
in burden of 0.3 minutes of clinical staff time to report data at start
of care (SOC), 0.3 minutes of clinical staff time to report data at
resumption of care (ROC) and 0.3 minutes of clinical staff time to
report data at Discharge.
As discussed in section V.E. of this final rule with comment
period, we are finalizing the adoption of two new measures: (1)
Transfer of Health Information to Provider-Post-Acute Care (PAC); and
(2) Transfer of Health Information to Patient-Post-Acute Care (PAC),
beginning with the CY 2022 HH QRP. We estimate the data elements for
the Transfer of Health Information
[[Page 60633]]
quality measures will take 0.6 minutes of clinical staff time to report
data at Discharge and 0.3 minutes of clinical staff time to report data
at Transfer of Care (TOC).
In section V.G. of this final rule with comment period, we are
finalizing the collection of standardized patient assessment data
beginning with the CY 2022 HH QRP. We estimate the SPADEs will take
10.05 minutes of clinical staff time to report data at SOC, 9.15
minutes of clinical staff time to report at ROC, and 10.95 minutes of
clinical staff time to report data at Discharge.
We estimate that there would be a net increase in clinician burden
per OASIS assessment of 9.75 minutes at SOC, 8.85 minutes at ROC, 0.3
minutes at TOC, and 11.25 minutes at Discharge as a result of the HH
QRP proposals finalized in this rule.
The OASIS is completed by RNs or PTs, or very occasionally by
occupational therapists (OT) or speech language pathologists (SLP/ST).
Data from 2018 show that the SOC/ROC OASIS is completed by RNs
(approximately 84.5 percent of the time), PTs (approximately 15.2
percent of the time), and other therapists, including OTs and SLP/STs
(approximately 0.3 percent of the time). Based on this analysis, we
estimated a weighted clinician average hourly wage of $74.58, inclusive
of fringe benefits, using the hourly wage data in Table 33. Individual
providers determine the staffing resources necessary.
Table 34 shows the total number of OASIS assessments submitted by
HHAs in CY 2018 and estimated burden at each time point.
[GRAPHIC] [TIFF OMITTED] TR08NO19.052
Based on the data in Table 34, for the 11,385 active Medicare-
certified HHAs in February 2019, we estimate the total average increase
in cost associated with changes to the HH QRP at approximately
$15,081.76 per HHA annually, or $171,705,794.10 for all HHAs annually.
This corresponds to an estimated increase in clinician burden
associated with changes to the HH QRP of approximately 202.2 hours per
HHA annually, or 2,302,303.5 hours for all HHAs annually. This
estimated increase in burden will be accounted for in the information
collection under OMB control number 0938-1279.
IX. 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,
require the Secretary to implement a 30-day unit of service, effective
for CY 2020, and calculate a 30-day payment amount for CY 2020 in a
budget neutral manner, respectively. In addition, section 1895(b)(4)(B)
of the Act, as amended by
[[Page 60634]]
section 51001(a)(3) of the BBA of 2018 requires the Secretary to
eliminate the use of the number of therapy visits provided to determine
payment, also effective for CY 2020.
2. HHVBP
The HHVBP Model applies a payment adjustment based on an HHA's
performance on quality measures to test the effects on quality and
expenditures.
3. HH QRP
Section 1895(b)(3)(B)(v) of the Act requires HHAs to submit data
for purposes of measuring heath care quality, and links the quality
data submission to the annual applicable percentage increase.
4. Home Infusion Therapy
Section 1834(u)(1) of the Act, as added by section 5012 of the 21st
Century Cures Act, requires the Secretary to establish a home infusion
therapy services payment system under Medicare. Under this payment
system a single payment would be 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 is for each infusion drug administration calendar day
in the individual's home. The Secretary shall, as appropriate,
establish single payment amounts for types of infusion therapy,
including to take 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 Physician 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. Section 1834(u)(1)(B)(i) of the
Act requires that the single payment amount be adjusted by a geographic
wage index. Finally, section 1834(u)(1)(C) of the Act allows for
discretionary adjustments which may include outlier payments and other
factors as deemed appropriate by the Secretary, and are required to be
made in a budget neutral manner. This payment system would become
effective for home infusion therapy items and services furnished on or
after January 1, 2021, and is not reflective of cost estimates for CY
2020.
Section 50401 of the BBA of 2018 amended section 1834(u) of the
Act, by adding a new paragraph (7). The paragraph establishes a home
infusion therapy temporary transitional payment for eligible home
infusion therapy suppliers for items and services associated with the
furnishing of transitional home infusion drugs for CYs 2019 and 2020.
Under this payment methodology (as described in section VI.B. of this
final rule with comment period), the Secretary established three
payment categories at amounts equal to the amounts determined under the
Physician Fee Schedule established under section 1848 of the Act. This
rule continues this categorization for services furnished during CY
2020 for codes and units of such codes, determined without application
of the geographic adjustment.
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. 804(2)), and Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs
(January 30, 2017).
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). We estimate that this rulemaking 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 to the best of our ability presents the
costs and benefits of the rulemaking.
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
follow costs associated with the provisions of this final rule with
comment period:
HH PPS--The net transfer impact related to the changes in
payments under the HH PPS for CY 2020 is estimated to be $250 million
(1.3 percent). This reflects the effects of the CY 2020 home health
payment update percentage of 1.5 percent ($290 million increase), and a
0.2 percent decrease in payments due to the rural add-on percentages
mandated by the Bipartisan Budget Act of 2018 for CY 2020 ($40 million
decrease). The home health wage index update for CY 2020 and the
updated FDL ratio that will be used for outlier payments in CY 2020 are
both budget-neutral.
HHVBP--The savings impacts related to the HHVBP Model as a
whole are estimated at $378 million for CYs 2018 through 2022. We do
not believe the policy finalized in this final rule with comment period
would affect the prior estimate.
HH QRP--The cost impact for HHA's related to proposed
changes to the HH QRP are estimated at $167.8 million.
Home Infusion Therapy--The CY 2020 cost impact related to
the routine updates to the temporary transitional payments for home
infusion therapy in CY 2020 is an estimated 1.9 percent, or $1.2
million, decrease in payments to home infusion therapy suppliers in CY
2020 based on the proposed CY 2020 Physician Fee Schedule (PFS) payment
amounts for such services (the final CY 2020 PFS payment amounts were
not available in time for this final rule with comment period). The
cost impact in CY 2021 related to the implementation of the permanent
home infusion therapy benefit is estimated to be a $2 million reduction
in payments to home infusion therapy suppliers.
[[Page 60635]]
C. Anticipated Effects
1. HH PPS and Home Infusion Therapy
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 in this final rule with comment period will result in an
estimated total impact of 3 to 5 percent or more on Medicare revenue
for greater than 5 percent of HHAs and home infusions therapy
suppliers. Therefore, the Secretary has determined that this HH PPS
final rule with comment period will have a significant economic impact
on a substantial number of small entities. We refer stakeholders to
Tables 35 and 36 which contain some information on the numbers of small
entities impacted by the rule.
In addition, section 1102(b) of the Act requires us to prepare a
final RIA if a rule has a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 604 of 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 with comment period 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 2019, that
threshold is approximately $150 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 $150 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 final rule with comment period
under these criteria of Executive Order 13132, and have determined that
it will not impose substantial direct costs on state or local
governments.
One commenter expressed concerns that CMS is not considering the
requirements of the Regulatory Flexibility Act or the Small Business
Regulatory Enforcement Fairness Act, which limits the impact on small
businesses. We refer commenters to section III.B. of this final rule
with comment period for our response to this comment.
2. HHVBP
Under the HHVBP Model, the first payment adjustment was applied in
CY 2018 based on PY 1 (2016) data and the final payment adjustment will
apply in CY 2022 based on PY 5 (2020) data. In the CY 2016 HH PPS final
rule, we estimated that the overall impact of the HHVBP Model from CY
2018 through CY 2022 was a reduction of approximately $380 million (80
FR 68716). In the CYs 2017, 2018, and 2019 HH PPS final rules, we
estimated that the overall impact of the HHVBP Model from CY 2018
through CY 2022 was a reduction of approximately $378 million (81 FR
76795, 82 FR 51751, and 83 FR 56593, respectively). We do not believe
the policy that we are finalizing will affect the prior estimate.
3. HH QRP
Section VIII. of this final rule with comment period provides a
detailed description of the net increase in burden associated with
changes to the HH QRP. We have estimated this associated burden
beginning with CY 2021 because HHAs will be required to submit data
beginning with that calendar year. The cost impact related to OASIS
item collection as a result of the changes to the HH QRP is estimated
to be a net increase of approximately $171.7 million in annualized cost
to HHAs, discounted at 7 percent relative to year 2016, over a
perpetual time horizon beginning in CY 2021.
4. Regulatory Review Cost Estimation
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this final rule with
comment period, 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 final rule with comment
period would be the similar to the number of reviewers on last year's
final rule with comment period. 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 with comment
period 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 also recognize that different types of
entities are in many cases affected by mutually exclusive sections of
this final rule with comment period, and therefore for the purposes of
our estimate we assume that each reviewer reads approximately 50
percent of the rule. While we solicited comments on the approach in
estimating the number of entities which would review the proposed rule
and the assumption of how much of the rule reviewers would read, we did
not receive any comments. Therefore, 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 with comment period 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 5
hours for the staff to review half of this final rule with comment
period, which consists of approximately 152,000 words. For each HHA
that reviews the final rule with comment period, the estimated cost is
$546.80 (5 hours x $109.36). Therefore, we estimate that the total cost
of reviewing this final rule with comment period is $292,632 ($546.80 x
537 reviewers).
[[Page 60636]]
D. Detailed Economic Analysis
1. HH PPS
This final rule with comment period finalizes updates to Medicare
payments under the HH PPS for the CY 2020. This rule with comment
period also implements changes in the case-mix adjustment methodology
for home health periods of care beginning on and after January 1, 2020
and implements the change in the unit of payment from 60-day episodes
to 30-day periods. The impact analysis of this final rule with comment
period presents the estimated expenditure effects of policy changes
finalized 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 from 2018. 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 35 represents how HHA revenues are likely to be affected by
the policy changes in this rule for CY 2020. For this analysis, we used
an analytic file with linked CY 2018 OASIS assessments and HH claims
data for dates of service that ended on or before December 31, 2018 (as
of July 31, 2019). The first column of Table 35 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 the CY 2020 wage index. The fourth column
shows the payment effects of the CY 2020 rural add-on payment provision
in statute. The fifth column shows the effects of the implementation of
the PDGM case-mix methodology for CY 2020. The sixth column shows the
payment effects of the CY 2020 home health payment update percentage as
required by section 53110 of the BBA of 2018. And the last column shows
the combined effects of all the policies finalized in this rule with
comment period.
Overall, it is projected that aggregate payments in CY 2020 would
increase by 1.3 percent. As illustrated in Table 35, 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 2020 wage index, the extent to which
HHAs are affected by changes in case-mix weights between the current
153-group case-mix model and the case-mix weights under the 432-group
PDGM, the percentage of total HH PPS payments that were subject to the
low-utilization payment adjustment (LUPA) or paid as outlier payments,
and the degree of Medicare utilization.
[[Page 60637]]
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[[Page 60638]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.054
2. HHVBP
As discussed in section IV. of this final rule with comment period,
for the HHVBP Model, we proposed and are finalizing the public
reporting of certain performance data for PY 5 (CY 2020) of the Model.
This finalized policy does not affect our analysis of the distribution
of payment adjustments for PY 5 as presented in the CY 2019 HH PPS
final rule with comment period. Therefore, we are not providing a
detailed analysis.
3. HH QRP
Failure to submit data required under section 1895(b)(3)(B)(v) of
the Act with respect to a calendar year will result in the reduction of
the annual home health market basket percentage increase otherwise
applicable to a HHA for that calendar year by 2 percentage points. For
the CY 2019 payment determination, 1,286 of the 11,444 active Medicare-
certified HHAs, or approximately 11.2 percent, did not receive the full
annual percentage increase. Information is not available to determine
the precise number of HHAs that would not meet the requirements to
receive the full annual percentage increase for the CY 2020 payment
determination.
As discussed in section V.D. of this final rule with comment
period, we proposed to remove one measure beginning with the CY 2022 HH
QRP. The measure we proposed to remove is Improvement in Pain
Interfering with Activity Measure (NQF #0177). As discussed in section
V.E. of this final rule with comment period, we proposed to add two
measures beginning with the CY 2022 HH QRP. The two measures we
proposed to adopt are: (1) Transfer of Health Information to Provider-
Post-Acute Care; and (2) Transfer of Health Information to Patient-
Post-Acute Care. As discussed in section V.G. of this final rule with
comment period, we are also proposed to collect standardized patient
assessment data beginning with the CY 2022 HH QRP. Section VII. of this
final rule with comment period provides a detailed description of the
net increase in burden associated with these proposed changes. We have
estimated this associated burden beginning with CY 2021 because HHAs
will be required to submit data beginning with that calendar year. The
cost impact related to OASIS item collection as a result of the changes
to the HH QRP is estimated to
[[Page 60639]]
be a net increase of approximately $167.8 million in annualized cost to
HHAs, discounted at 7 percent relative to year 2016, over a perpetual
time horizon beginning in CY 2021.
4. Home Infusion Therapy Services Payment
a. Home Infusion Therapy Services Temporary Transitional Payment
The impact due to the updated payment amounts for furnishing home
infusion therapy services is determined based on the rates published in
the physician fee schedule established under section 1848 of the Act.
At the time of publication of this final rule with comment period, the
CY 2020 PFS final payment rates were not available. However, we
estimate the impact in CY 2020, based on the CY 2020 PFS proposed
rates, would result in a 1.9 percent decrease in overall payments for
home infusion therapy suppliers receiving temporary transitional
payments.
b. Home Infusion Therapy Services Payment for CY 2021 and Subsequent
Years
The following analysis applies to payment for home infusion therapy
as set forth in section 1834(u)(1) of the Act, as added by section 5012
of the 21st Century Cures Act (Pub. L. 114-255), and accordingly,
describes the preliminary impact for CY 2021 only. We should also note
that as payment amounts are contingent on the Physician Fee Schedule
(PFS) rates, this impact analysis will be affected by whether rates
increase or decrease in CY 2021. We used CY 2018 claims data to
identify beneficiaries with DME claims containing 1 of the codes
identified on the DME LCD for External Infusion Pumps (L33794),
excluding drugs that are statutorily excluded from coverage under the
permanent home infusion therapy benefit. These include insulin, drugs
and biologicals listed on self-administered drug exclusion lists, and
drugs administered by routes other than intravenous or subcutaneous
infusion. Because we do not have complete data for CY 2019 (the first
year of the temporary transitional payments), we used the visit
assumptions identified in the CY 2019 HH PPS final rule with comment
period. We calculated the total weeks of care, which is the sum of
weeks of care across all beneficiaries found in each category (as
determined from the CY 2018 claims). Weeks of care for categories 1 and
3 are defined as the week of the last infusion drug or pump claim minus
the week of the first infusion drug or pump claim plus one.
Additionally for these categories, we assumed 2 visits for the initial
week of care, with 1 visit per week for all subsequent weeks in order
to estimate the total visits of care per category. For category 2, we
assumed 1 visit per month, or 12 visits per year. For this analysis, we
did not factor in an increase in beneficiaries receiving home infusion
therapy services due to switching from physician's offices or
outpatient centers. Because home infusion therapy services under
Medicare are contingent on utilization of the DME benefit, we
anticipate utilization will remain fairly stable and that there will be
no significant changes in the settings of care where current infusion
therapy is provided. We will continue to monitor utilization to
determine if referral patterns change significantly during the
temporary transitional payment period, and once the permanent benefit
is implemented in CY 2021.
Table 36 reflects the estimated wage-adjusted beneficiary impact,
representative of a 4-hour payment rate, compared to a 5-hour payment
rate, excluding statutorily excluded drugs and biologicals. Column 3
represents the percent change from the estimated CY 2020 transitional
payment to the estimated CY 2021 payment after applying the geographic
adjustment factor (GAF). Column 4 represents the percent change from
the estimated CY 2021 payment after applying the GAF to the estimated
CY 2021 payment after removing the statutorily excluded drugs and
biologicals. Column 5 represents the percent change from the estimated
CY 2021 payment after applying the GAF and removing the statutorily
excluded drugs and biologicals to the estimated CY 2021 payment, and
after applying the higher reimbursement rate. Overall, we estimate a
3.6 percent decrease ($2 million) in payments to home infusion therapy
suppliers in CY 2021.
BILLING CODE 4120-01-P
[[Page 60640]]
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BILLING CODE 4120-01-C
E. Alternatives Considered
1. HH PPS
This final rule with comment period contains a range of policies,
including some provisions related to specific statutory provisions. The
preceding preamble provides descriptions of the statutory provisions
that are addressed, identifies those policies when discretion has been
exercised, presents rationale for our final policies and, where
relevant, alternatives that were considered.
2. HHVBP
With regard to our proposal to publicly report on the CMS website
the CY 2020 (PY 5) Total Performance Score (TPS) and the percentile
ranking of the TPS for each competing HHA that qualifies for a payment
adjustment in CY 2020, we also considered not making this Model
performance data public, and whether there was any potential cost to
stakeholders and beneficiaries if the data were to be misinterpreted.
However, for the reasons discussed in section IV. of this final rule
with comment period, we are finalizing the public reporting of the
HHVBP Model performance data for PY 5 as proposed. We believe that
providing definitions for the HHVBP TPS and the TPS Percentile Ranking
methodology would address any such concerns by ensuring the public
understands the relevance of these data points and how they were
calculated. We also considered the financial costs associated with our
proposal to publicly report HHVBP data, but do not anticipate such
costs to CMS, stakeholders or beneficiaries, as CMS already calculates
and reports the TPS and TPS Percentile Ranking in the
[[Page 60641]]
Annual Reports to HHAs. As discussed in section IV of this final rule
with comment period, we believe the public reporting of such data would
further enhance quality reporting under the Model by encouraging
participating HHAs to provide better quality of care through focusing
on quality improvement efforts that could potentially improve their
TPS. In addition, we believe that publicly reporting performance data
that indicates overall performance may assist beneficiaries,
physicians, discharge planners, and other referral sources in choosing
higher-performing HHAs within the nine Model states and allow for more
meaningful and objective comparisons among HHAs on their level of
quality relative to their peers.
3. HH QRP
We believe that removing the Pain Interfering with Activity Measure
(NQF #0177) from the HH QRP beginning with the CY 2022 HH QRP would
reduce negative unintended consequences. We proposed the removal of the
measure under Meaningful Measures Initiative measure removal Factor 7:
Collection or public reporting of a measure leads to negative
unintended consequences other than patient harm. We considered
alternatives to this measure and no appropriate alternative measure is
ready at this time. Out of an abundance of caution to potential harm
from over-prescription of opioid medications inadvertently driven by
this measure, we have determined that removing the current pain measure
is the most appropriate provision.
The finalization of the proposed adoption of two transfer of health
information process measures is vital to satisfying section
1899B(c)(1)(E)(ii) of the Act, which requires that the quality measures
specified by the Secretary include measures with respect to the quality
measure domain of accurately communicating the existence of and
providing for the transfer of health information and care preferences
of an individual when the individual transitions from a PAC provider to
another applicable setting. We believe adopting these measures best
addresses the requirements of the IMPACT Act for this domain. We
considered not adopting these proposals and doing additional analyses
for a future implementation. This approach was not viewed as a viable
alternative because of the extensive effort invested in creating the
best measures possible and failure to adopt measures in the domain of
transfer of health information puts CMS at risk of not meeting the
legislative mandate of the IMPACT Act.
Collecting and reporting standardized patient assessment data under
the HH QRP is required under section 1899B(b)(1) of the Act. We have
carefully considered assessment items for each of the categories of
assessment data and believe these proposals best addressed the
requirements of the Act for the HH QRP. The proposed SPADEs are items
that received additional national testing after they were proposed in
the CY 2018 HH PPS proposed rule (82 FR 35354 through 35371) and more
extensively vetted. These items have been carefully considered and the
alternative of not proposing to adopt standardized patient assessment
data will result in CMS not meeting our legislative mandate under the
IMPACT Act.
4. Home Infusion Therapy
This final rule with comment period contains a range of policies,
including some provisions related to specific statutory provisions. The
preceding preamble provides descriptions of the statutory provisions
that are addressed, identifies those policies when discretion has been
exercised, presents rationale for our final policies and, where
relevant, alternatives that were considered.
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 37, we have prepared an accounting statement showing
the classification of the transfers and costs associated with the CY
2020 HH PPS provisions of this rule. Table 38 shows the burden to HHA's
for submission of OASIS. Table 39 provides our best estimate of the
increase in Medicare payments to home infusion therapy suppliers for
home infusion therapy beginning in CY 2021.
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[GRAPHIC] [TIFF OMITTED] TR08NO19.057
[[Page 60642]]
[GRAPHIC] [TIFF OMITTED] TR08NO19.058
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.''
This final rule with comment period is considered an E.O. 13771
regulatory action. We estimate the rule generates $169.9 million in
annualized costs in 2016 dollars, discounted at 7 percent relative to
year 2016 over a perpetual time horizon. Details on the estimated costs
of this rule can be found in the preceding and subsequent analyses.
H. Conclusion
1. HH PPS for CY 2020
In conclusion, we estimate that the net impact of the HH PPS
policies in this rule is an increase of 1.3 percent, or $250 million,
in Medicare payments to HHAs for CY 2020. This reflects the effects of
the CY 2020 home health payment update percentage of 1.5 percent ($290
million increase), and a 0.2 percent decrease in payments due to the
declining rural add-on percentages mandated by the Bipartisan Budget
Act of 2018 for CY 2020 ($40 million decrease). The home health wage
index update for CY 2020 and the updated FDL ratio that will be used
for outlier payments in CY 2020 are both budget-neutral. Effects of the
implementation of the PDGM and the change to a 30-day unit of payment
are also budget-neutral.
2. HHVBP
In conclusion, as noted previously for the HHVBP Model, we are
finalizing our proposal to publicly report performance data for PY 5
(CY 2020) of the Model. This finalized policy does not affect our
analysis of the distribution of payment adjustments for PY 5 as
presented in the CY 2019 HH PPS final rule with comment period.
We estimate there would be no net impact (to include either a net
increase or reduction in payments) for this final rule with comment
period in Medicare payments to HHAs competing in the HHVBP Model.
However, the overall economic impact of the HHVBP Model is an estimated
$378 million in total savings from a reduction in unnecessary
hospitalizations and SNF usage as a result of greater quality
improvements in the home health industry over the life of the HHVBP
Model.
3. HH QRP
In conclusion, we estimate that the changes to OASIS item
collection as a result of the changes to the HH QRP effective on
January 1, 2021 result in a net additional annualized cost of $167.8
million, discounted at 7 percent relative to year 2016, over a
perpetual time horizon beginning in CY 2021.
4. Home Infusion Therapy
a. Home Infusion Therapy Services Temporary Transitional Payment for CY
2020
In conclusion, we estimate a 1.9 percent, or $1.2 million, decrease
in payments to home infusion therapy suppliers in CY 2020 based on the
proposed CY 2020 Physician Fee Schedule (PFS) payment amounts for such
services established under section 1848 of the Act (the final CY 2020
PFS payment amounts were not available in time for this final rule with
comment period).
b. Home Infusion Therapy Services Payment for CY 2021
In conclusion, we estimate that the net impact of the payment for
home infusion therapy services for CY 2021 is approximately $2 million
in reduced payments to home infusion therapy suppliers.
This analysis, together with the remainder of this preamble,
provides an initial Regulatory Flexibility Analysis.
In accordance with the provisions of Executive Order 12866, this
final rule with comment period was reviewed by the OMB.
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 484
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 486
Grant programs--health, Health facilities, Medicare, Reporting and
recordkeeping requirements, X-rays.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 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 paragraph (a) 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.
(1) The HHA must be acting upon a physician plan of care that meets
the requirements of this section for HHA services to be covered.
(2) For HHA services to be covered, the individualized plan of care
must specify the services necessary to meet the patient-specific needs
identified in the comprehensive assessment.
(3) The plan of care must include 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. All care provided must be in
accordance with the plan of care.
* * * * *
0
3. Section 409.44 is amended by revising paragraph (c)(2)(iii)(C) to
read as follows:
[[Page 60643]]
Sec. 409.44 Skilled services requirements.
* * * * *
(c) * * *
(2) * * *
(iii) * * *
(C) The unique clinical condition of a patient may require the
specialized skills of a qualified therapist or therapist assistant to
perform a safe and effective maintenance program required in connection
with the patient's specific illness or injury. Where the clinical
condition of the patient is such that the complexity of the therapy
services required--
(1) Involve the use of complex and sophisticated therapy procedures
to be delivered by the therapist or the therapist assistant in order to
maintain function or to prevent or slow further deterioration of
function; or
(2) To maintain function or to prevent or slow further
deterioration of function must be delivered by the therapist or the
therapist assistant in order to ensure the patient's safety and to
provide an effective maintenance program, then those reasonable and
necessary services must be covered.
* * * * *
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
4. The authority citation for part 414 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(1).
0
5. Add subpart P to read as follows:
Subpart P--Home Infusion Therapy Services Payment
Conditions for Payment
Sec.
414.1500 Basis, purpose, and scope.
414.1505 Requirement for payment.
414.1510 Beneficiary qualifications for coverage of services.
414.1515 Plan of care requirements.
Payment System
414.1550 Basis of payment.
Subpart P--Home Infusion Therapy Services Payment
Conditions for Payment
Sec. 414.1500 Basis, purpose, and scope.
This subpart implements section 1861(iii) of the Act with respect
to the requirements that must be met for Medicare payment to be made
for home infusion services furnished to eligible beneficiaries.
Sec. 414.1505 Requirement for payment.
In order for home infusion therapy services to qualify for payment
under the Medicare program the services must be furnished to an
eligible beneficiary by, or under arrangements with, a qualified home
infusion therapy supplier that meets the following requirements:
(a) The health and safety standards for qualified home infusion
therapy suppliers at Sec. 486.520(a) through (c) of this chapter.
(b) All requirements set forth in Sec. Sec. 414.1510 through
414.1550.
Sec. 414.1510 Beneficiary qualifications for coverage of services.
To qualify for Medicare coverage of home infusion therapy services,
a beneficiary must meet each of the following requirements:
(a) Under the care of an applicable provider. The beneficiary must
be under the care of an applicable provider, as defined in section
1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or
physician assistant.
(b) Under a physician plan of care. The beneficiary must be under a
plan of care that meets the requirements for plans of care specified in
Sec. 414.1515.
Sec. 414.1515 Plan of care requirements.
(a) Contents. The plan of care must contain those items listed in
Sec. 486.520(b) of this chapter that specify the standards relating to
a plan of care that a qualified home infusion therapy supplier must
meet in order to participate in the Medicare program.
(b) Physician's orders. The physician's orders for services in the
plan of care must specify at what frequency the services will be
furnished, as well as the discipline that will furnish the ordered
professional services. Orders for care may indicate a specific range in
frequency of visits to ensure that the most appropriate level of
services is furnished.
(c) Plan of care signature requirements. The plan of care must be
signed and dated by the ordering physician prior to submitting a claim
for payment. The ordering physician must sign and date the plan of care
upon any changes to the plan of care.
Payment System
Sec. 414.1550 Basis of payment.
(a) General rule. For home infusion therapy services furnished on
or after January 1, 2021, Medicare payment is made on the basis of 80
percent of the lesser of the following:
(1) The actual charge for the item or service.
(2) The fee schedule amount for the item or service, as determined
in accordance with the provisions of this section.
(b) Unit of single payment. A unit of single payment is made for
items and services furnished by a qualified home infusion therapy
supplier per payment category for each infusion drug administration
calendar day, as defined at Sec. 486.505 of this chapter.
(c) Initial establishment of the payment amounts. In calculating
the initial single payment amounts for CY 2021, CMS determined such
amounts using the equivalent to 5 hours of infusion services in a
physician's office as determined by codes and units of such codes under
the annual fee schedule issued under section 1848 of the Act as
follows:
(1) Category 1. (i) Includes certain intravenous infusion drugs for
therapy, prophylaxis, or diagnosis, including antifungals and
antivirals; inotropic and pulmonary hypertension drugs; pain management
drugs; chelation drugs; and other intravenous drugs as added to the
durable medicare equipment local coverage determination (DME LCD) for
external infusion pumps.
(ii) Payment equals 1 unit of 96365 plus 4 units of 96366.
(2) Category 2. (i) Includes certain subcutaneous infusion drugs
for therapy or prophylaxis, including certain subcutaneous
immunotherapy infusions.
(ii) Payment equals 1 unit of 96369 plus 4 units of 96370.
(3) Category 3. (i) Includes intravenous chemotherapy infusions,
including certain chemotherapy drugs and biologicals.
(ii) Payment equals 1 unit of 96413 plus 4 units of 96415.
(4) Initial visit. (i) For each of the three categories listed in
paragraphs (c)(1) through (3) of this section, the payment amounts are
set higher for the first visit by the qualified home infusion therapy
supplier to initiate the furnishing of home infusion therapy services
in the patient's home and lower for subsequent visits in the patient's
home. The difference in payment amounts is a percentage based on the
relative payment for a new patient rate over an existing patient rate
using the annual physician fee schedule evaluation and management
payment amounts for a given year and calculated in a budget neutral
manner.
(ii) The first visit payment amount is subject to the following
requirements if a patient has previously received home infusion therapy
services:
(A) The previous home infusion therapy services claim must include
a patient status code to indicate a discharge.
(B) If a patient has a previous claim for HIT services, the first
visit home
[[Page 60644]]
infusion therapy services claim subsequent to the previous claim must
show a gap of more than 60 days between the last home infusion therapy
services claim and must indicate a discharge in the previous period
before a HIT supplier may submit a home infusion therapy services claim
for the first visit payment amount.
(d) Required payment adjustments. The single payment amount
represents payment in full for all costs associated with the furnishing
of home infusion therapy services and is subject to the following
adjustments:
(1) An adjustment for a geographic wage index and other costs that
may vary by region, using an appropriate wage index based on the site
of service of the beneficiary.
(2) Beginning in 2022, an annual increase in the single payment
amounts from the prior year by the percentage increase in the Consumer
Price Index (CPI) for all urban consumers (United States city average)
for the 12-month period ending with June of the preceding year.
(3)(i) An annual reduction in the percentage increase described in
paragraph (d)(2) of this section by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act.
(ii) The application of the paragraph (c)(3)(i) of this section may
result in the both of the following:
(A) A percentage being less than zero for a year.
(B) Payment being less than the payment rates for the preceding
year.
(e) Medical review. All payments under this system may be subject
to a medical review adjustment reflecting the following:
(1) Beneficiary eligibility.
(2) Plan of care requirements.
(3) Medical necessity determinations.
PART 484--HOME HEALTH SERVICES
0
6. The authority citation for part 484 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395(hh) unless otherwise
indicated.
0
7. Section 484.202 is amended by adding the definitions of ``HHCAHPS''
and ``HH QRP'' in alphabetical order to read as follows:
Sec. 484.202 Definitions.
* * * * *
HHCAHPS stands for Home Health Care Consumer Assessment of
Healthcare Providers and Systems.
HH QRP stands for Home Health Quality Reporting Program.
* * * * *
0
8. Section 484.205 is amended by--
0
a. Revising paragraph (g)(2);
0
b. Adding paragraphs (g)(3) and (4);
0
c. Revising the heading for paragraph (h); and
0
d. Adding paragraphs (i) and (j).
The revisions and additions read as follows:
Sec. 484.205 Basis of payment.
* * * * *
(g) * * *
(2) Split percentage payments for periods beginning on or after
January 1, 2020 through December 31, 2020--(i) HHAs certified for
participation on or before December 31, 2018. (A) The initial payment
for all 30-day periods is paid to an HHA at 20 percent of the case-mix
and wage-adjusted 30-day payment rate.
(B) The residual final payment for all 30-day periods is paid at 80
percent of the case-mix and wage-adjusted 30-day payment rate.
(ii) HHAs certified for participation in Medicare on or after
January 1, 2019. Split percentage payments are not made to HHAs that
are certified for participation in Medicare effective on or after
January 1, 2019. Newly enrolled HHAs must submit a request for
anticipated payment, which is set at 0 percent, at the beginning of
every 30-day period. An HHA that is certified for participation in
Medicare effective on or after January 1, 2019 receives a single
payment for a 30-day period of care after the final claim is submitted.
(3) Split percentage payments for periods beginning on or after
January 1, 2021 through December 31, 2021. All HHAs must submit a
request for anticipated payment within 5 calendar days after the start
of care date for initial 30-day periods and within 5 calendar days
after the ``from date'' for each subsequent 30-day period of care,
which is set at 0 percent at the beginning of every 30-day period. HHAs
receive a single payment for a 30-day period of care after the final
claim is submitted.
(4) Payments for periods beginning on or after January 1, 2022. All
HHAs must submit a Notice of Admission (NOA) at the beginning of the
initial 30-day period of care as described in paragraph (j) of this
section. HHAs receive a single payment for a 30-day period of care
after the final claim is submitted.
(h) Requests for anticipated payment (RAP) for 30-day periods of
care starting on January 1, 2020 through December 31, 2020. * * *
(i) Submission of RAPs for CY 2021--(1) General. All HHAs must
submit a RAP, which is to be paid at 0 percent, within 5 calendar days
after the start of care and within 5 calendar days after the ``from
date'' for each subsequent 30-day period of care.
(2) Criteria for RAP submission for CY 2021. The HHA shall submit
RAPs only when all of the following conditions are met:
(i) Once physician's written or verbal orders that contain the
services required for the initial visit have been received and
documented as required at Sec. Sec. 484.60(b) and 409.43(d) of this
chapter.
(ii) The initial visit within the 60-day certification period must
have been made and the individual admitted to home health care.
(3) Consequences of failure to submit a timely RAP. When a home
health agency does not file the required RAP for its Medicare patients
within 5 calendar days after the start of each 30-day period of care--
(i) Medicare does not pay for those days of home health services
based on the ``from date'' on the claim to the date of filing of the
RAP;
(ii) The wage and case-mix adjusted 30-day period payment amount is
reduced by 1/30th for each day from the home health based on the ``from
date'' on the claim until the date of filing of the RAP;
(iii) No LUPA payments are made that fall within the late period;
(iv) The payment reduction cannot exceed the total payment of the
claim; and
(v)(A) The non-covered days are a provider liability; and
(B) The provider must not bill the beneficiary for the non-covered
days.
(4) Exception to the consequences for filing the RAP late. (i) CMS
may waive the consequences of failure to submit a timely-filed RAP
specified in paragraph (i)(3) of this section.
(ii) CMS determines if a circumstance encountered by a home health
agency is exceptional and qualifies for waiver of the consequence
specified in paragraph (i)(3) of this section.
(iii) A home health agency must fully document and furnish any
requested documentation to CMS for a determination of exception. An
exceptional circumstance may be due to, but is not limited to the
following:
(A) Fires, floods, earthquakes, or similar unusual events that
inflict extensive damage to the home health agency's ability to
operate.
(B) A CMS or Medicare contractor systems issue that is beyond the
control of the home health agency.
(C) A newly Medicare-certified home health agency that is notified
of that certification after the Medicare certification date, or which
is awaiting its user ID from its Medicare contractor.
[[Page 60645]]
(D) Other situations determined by CMS to be beyond the control of
the home health agency.
(j) Submission of Notice of Admission (NOA)--(1) For periods of
care that begin on and after January 1, 2022. For all 30-day periods of
care after January 1, 2022, all HHAs must submit a Notice of Admission
(NOA) to their Medicare contractor within 5 calendar days after the
start of care date. The NOA is a one-time submission to establish the
home health period of care and covers contiguous 30-day periods of care
until the individual is discharged from Medicare home health services.
(2) Criteria for NOA submission. In order to submit the NOA, the
following criteria must be met:
(i) Once a physician's written or verbal orders that contains the
services required for the initial visit have been received and
documented as required at Sec. Sec. 484.60(b) and 409.43(d) of this
chapter.
(ii) The initial visit must have been made and the individual
admitted to home health care.
(3) Consequences of failure to submit a timely Notice of Admission.
When a home health agency does not file the required NOA for its
Medicare patients within 5 calendar days after the start of care--
(i) Medicare does not pay for those days of home health services
from the start date to the date of filing of the notice of admission;
(ii) The wage and case-mix adjusted 30-day period payment amount is
reduced by 1/30th for each day from the home health start of care date
until the date of filing of the NOA;
(iii) No LUPA payments are made that fall within the late NOA
period;
(iv) The payment reduction cannot exceed the total payment of the
claim; and
(v)(A) The non-covered days are a provider liability; and
(B) The provider must not bill the beneficiary for the non-covered
days.
(4) Exception to the consequences for filing the NOA late. (i) CMS
may waive the consequences of failure to submit a timely-filed NOA
specified in paragraph (j)(3) of this section.
(ii) CMS determines if a circumstance encountered by a home health
agency is exceptional and qualifies for waiver of the consequence
specified in paragraph (j)(3) of this section.
(iii) A home health agency must fully document and furnish any
requested documentation to CMS for a determination of exception. An
exceptional circumstance may be due to, but is not limited to the
following:
(A) Fires, floods, earthquakes, or similar unusual events that
inflict extensive damage to the home health agency's ability to
operate.
(B) A CMS or Medicare contractor systems issue that is beyond the
control of the home health agency.
(C) A newly Medicare-certified home health agency that is notified
of that certification after the Medicare certification date, or which
is awaiting its user ID from its Medicare contractor.
(D) Other situations determined by CMS to be beyond the control of
the home health agency.
Sec. 484.225 [Amended]
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9. Section 484.225 is amended by--
0
a. Removing paragraph (b);
0
b. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c); and
0
c. In newly redesignated paragraph (c), removing the phrase
``paragraphs (a) through (c) of this section'' and adding in its place
the phrase ``paragraphs (a) and (b) of this section''.
0
10. Add Sec. 484.245 to read as follows:
Sec. 484.245 Requirements under the Home Health Quality Reporting
Program (HH QRP).
(a) Participation. Beginning January 1, 2007, an HHA must report
Home Health Quality Reporting Program (HH QRP) data in accordance with
the requirements of this section.
(b) Data submission. (1) Except as provided in paragraph (d) of
this section, and for a program year, an HHA must submit all of the
following to CMS:
(i) Data on measures specified under sections 1899B(c)(1) and
1899B(d)(1) of the Act.
(ii) Standardized patient assessment data required under section
1899B(b)(1) of the Act.
(iii) Quality data required under section 1895(b)(3)(B)(v)(II) of
the Act, including HHCAHPS survey data. For purposes of HHCAHPS survey
data submission, the following additional requirements apply:
(A) Patient count. An HHA that has less than 60 eligible unique
HHCAHPS patients must annually submit to CMS their total HHCAHPS
patient count to CMS to be exempt from the HHCAHPS reporting
requirements for a calendar year.
(B) Survey requirements. An HHA must contract with an approved,
independent HHCAHPS survey vendor to administer the HHCAHPS on its
behalf.
(C) CMS approval. CMS approves an HHCAHPS survey vendor if the
applicant has been in business for a minimum of 3 years and has
conducted surveys of individuals and samples for at least 2 years.
(1) For HHCAHPS, a ``survey of individuals'' is defined as the
collection of data from at least 600 individuals selected by
statistical sampling methods and the data collected are used for
statistical purposes.
(2) All applicants that meet the requirements in this paragraph
(b)(1)(iii)(C) are approved by CMS.
(D) Disapproval by CMS. No organization, firm, or business that
owns, operates, or provides staffing for an HHA is permitted to
administer its own HHCAHPS Survey or administer the survey on behalf of
any other HHA in the capacity as an HHCAHPS survey vendor. Such
organizations are not be approved by CMS as HHCAHPS survey vendors.
(E) Compliance with oversight activities. Approved HHCAHPS survey
vendors must fully comply with all HHCAHPS oversight activities,
including allowing CMS and its HHCAHPS program team to perform site
visits at the vendors' company locations.
(2) The data submitted under paragraph (b) of this section must be
submitted in the form and manner, and at a time, specified by CMS.
(c) Exceptions and extension requirements. (1) An HHA may request
and CMS may grant exceptions or extensions to the reporting
requirements under paragraph (b) of this section for one or more
quarters, when there are certain extraordinary circumstances beyond the
control of the HHA.
(2) An HHA may request an exception or extension within 90 days of
the date that the extraordinary circumstances occurred by sending an
email to CMS HHAPU reconsiderations at
[email protected] that contains all of the following
information:
(i) HHA CMS Certification Number (CCN).
(ii) HHA Business Name.
(iii) HHA Business Address.
(iv) CEO or CEO-designated personnel contact information including
name, title, telephone number, email address, and mailing address (the
address must be a physical address, not a post office box).
(v) HHA's reason for requesting the exception or extension.
(vi) Evidence of the impact of extraordinary circumstances,
including, but not limited to, photographs, newspaper, and other media
articles.
(vii) Date when the HHA believes it will be able to again submit
data under paragraph (b) of this section and a justification for the
proposed date.
(3) Except as provided in paragraph (c)(4) of this section, CMS
does not
[[Page 60646]]
consider an exception or extension request unless the HHA requesting
such exception or extension has complied fully with the requirements in
this paragraph (c).
(4) CMS may grant exceptions or extensions to HHAs without a
request if it determines that one or more of the following has
occurred:
(i) An extraordinary circumstance, such as an act of nature,
affects an entire region or locale.
(ii) A systemic problem with one of CMS's data collection systems
directly affects the ability of an HHA to submit data under paragraph
(b) of this section.
(d) Reconsiderations. (1)(i) HHAs that do not meet the quality
reporting requirements under this section for a program year will
receive a letter of noncompliance via the United States Postal Service
and the CMS-designated data submission system.
(ii) An HHA may request reconsideration no later than 30 calendar
days after the date identified on the letter of non-compliance.
(2) Reconsideration requests may be submitted to CMS by sending an
email to CMS HHAPU reconsiderations at
[email protected] containing all of the following
information:
(i) HHA CCN.
(ii) HHA Business Name.
(iii) HHA Business Address.
(iv) CEO or CEO-designated personnel contact information including
name, title, telephone number, email address, and mailing address (the
address must be a physical address, not a post office box).
(v) CMS identified reason(s) for non-compliance as stated in the
non-compliance letter.
(vi) Reason(s) for requesting reconsideration, including all
supporting documentation.
(3) CMS does not consider a reconsideration request unless the HHA
has complied fully with the submission requirements in paragraphs
(d)(1) and (2) of this section.
(4) CMS makes a decision on the request for reconsideration and
provide notice of the decision to the HHA via letter sent via the
United States Postal Service.
(e) Appeals. An HHA that is dissatisfied with CMS' decision on a
request for reconsideration submitted under paragraph (d) of this
section may file an appeal with the Provider Reimbursement Review Board
(PRRB) under 42 CFR part 405, subpart R.
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11. Section 484.250 is revised to read as follows:
Sec. 484.250 OASIS data.
An HHA must submit to CMS the OASIS data described at Sec.
484.55(b) and (d) as is necessary for CMS to administer the payment
rate methodologies described in Sec. Sec. 484.215, 484.220, 484.230,
484.235, and 484.240.
0
12. Section 484.315 is amended by revising the section heading and
adding paragraph (d) to read as follows:
Sec. 484.315 Data reporting for measures and evaluation and the
public reporting of model data under the Home Health Value-Based
Purchasing (HHVBP) Model.
* * * * *
(d) For performance year 5, CMS publicly reports the following for
each competing home health agency on the CMS website:
(1) The Total Performance Score.
(2) The percentile ranking of the Total Performance Score.
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY SUPPLIERS
0
13. The authority citation for part 486 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
14. Section 486.505 is amended by revising the definition of
``Applicable provider'' to read as follows:
Sec. 486.505 Definitions.
* * * * *
Applicable provider means a physician, a nurse practitioner, and a
physician assistant.
* * * * *
Dated: October 24, 2019.
Seema Verma,
Administrator, Centers for Medicare and Medicaid Services.
Dated: October 28, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-24026 Filed 10-31-19; 4:15 pm]
BILLING CODE 4120-01-P