[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Rules and Regulations]
[Pages 56406-56638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24145]
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Vol. 83
Tuesday,
No. 219
November 13, 2018
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, 424, 484, et al.
Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment
System Rate Update and CY 2020 Case-Mix Adjustment Methodology
Refinements; Home Health Value-Based Purchasing Model; Home Health
Quality Reporting Requirements; Home Infusion Therapy Requirements; and
Training Requirements for Surveyors of National Accrediting
Organizations; Final Rule
Federal Register / Vol. 83 , No. 219 / Tuesday, November 13, 2018 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409, 424, 484, 486, and 488
[CMS-1689-FC]
RIN 0938-AT29
Medicare and Medicaid Programs; CY 2019 Home Health Prospective
Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology
Refinements; Home Health Value-Based Purchasing Model; Home Health
Quality Reporting Requirements; Home Infusion Therapy Requirements; and
Training Requirements for Surveyors of National Accrediting
Organizations
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, including the
national, standardized 60-day episode payment rates, the national per-
visit rates, and the non-routine medical supply (NRS) conversion
factor, effective for home health episodes of care ending on or after
January 1, 2019. This rule also: Updates the HH PPS case-mix weights
for calendar year (CY) 2019 using the most current, complete data
available at the time of rulemaking; discusses our efforts to monitor
the potential impacts of the rebasing adjustments that were implemented
in CYs 2014 through 2017; finalizes a rebasing of the HH market basket
(which includes a decrease in the labor-related share); finalizes the
methodology used to determine rural add-on payments for CYs 2019
through 2022, as required by section 50208 of the Bipartisan Budget Act
of 2018 (Pub. L. 115-123) hereinafter referred to as the ``BBA of
2018''; finalizes regulations text changes regarding certifying and
recertifying patient eligibility for Medicare home health services; and
finalizes the definition of ``remote patient monitoring'' and the
recognition of the costs associated with it as allowable administrative
costs.
This rule also summarizes the case-mix methodology refinements for
home health services beginning on or after January 1, 2020, which
includes the elimination of therapy thresholds for payment and a change
in the unit of payment from a 60-day episode to a 30-day period, as
mandated by section 51001 of the Bipartisan Budget Act of 2018. This
rule also finalizes changes to the Home Health Value-Based Purchasing
(HHVBP) Model. In addition, with respect to the Home Health Quality
Reporting Program, this rule discusses the Meaningful Measures
Initiative; finalizes the removal of seven measures to further the
priorities of this initiative; discusses social risk factors and
provides an update on implementation efforts for certain provisions of
the IMPACT Act; and finalizes a regulatory text change regarding OASIS
data.
For the home infusion therapy benefit, this rule finalizes health
and safety standards that home infusion therapy suppliers must meet;
finalizes an approval and oversight process for accrediting
organizations (AOs) that accredit home infusion therapy suppliers;
finalizes the implementation of temporary transitional payments for
home infusion therapy services for CYs 2019 and 2020; and responds to
the comments received regarding payment for home infusion therapy
services for CY 2021 and subsequent years.
Lastly, in this rule, we are finalizing only one of the two new
requirements we proposed to implement in the regulations for the
oversight of AOs that accredit Medicare-certified providers and
suppliers. More specifically, for reasons set out more fully in the
section X. of this final rule with comment period, we have decided not
to finalize our proposal to require that all surveyors for AOs that
accredit Medicare-certified providers and suppliers take the same
relevant and program-specific CMS online surveyor training that the
State Agency surveyors are required to take.
However, we are finalizing our proposal to require that each AO
must provide a written statement with their application to CMS, stating
that if one of its fully accredited providers or suppliers, in good-
standing, provides written notification that they wish to voluntarily
withdraw from the AO's CMS-approved accreditation program, the AO must
continue the provider or supplier's current accreditation until the
effective date of withdrawal identified by the facility or the
expiration date of the term of accreditation, whichever comes first.
DATES:
Effective Date: This final rule with comment period is effective on
January 1, 2019.
Implementation Date: The Patient-Driven Groupings Model (PDGM)
case-mix methodology refinements and the change in the unit of payment
from 60-day episodes of care to 30-day periods of care will be for home
health services (30-day periods of care) beginning on or after January
1, 2020.
Comment Date: To be assured consideration, comments on the
definition of ``infusion drug administration calendar day'' at Sec.
486.505 and 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 31, 2018.
ADDRESSES: In commenting, please refer to file code CMS-1689-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-1689-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-1689-FC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
[Note: This zipcode for express mail or courier delivery only. This
zipcode specifies the agency's physical location.]
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
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) contact: Joan Proctor, (410) 786-0949.
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For information about home infusion therapy health and safety
standards, contact: CAPT Jacqueline Leach, (410) 786-4282 or Sonia
Swancy, (410) 786-8445.
For information about health infusion therapy accreditation and
oversight, contact: Caroline Gallaher (410) 786-8705.
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://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, Transfers, and Benefits
D. Improving Patient Outcomes and Reducing Burden Through
Meaningful Measures
II. Background
A. Statutory Background
B. Current System for Payment of Home Health Services
C. Updates to the Home Health Prospective Payment System
D. Advancing Health Information Exchange
III. Payment Under the Home Health Prospective Payment System (HH
PPS)
A. Monitoring for Potential Impacts--Affordable Care Act
Rebasing Adjustments
B. CY 2019 HH PPS Case-Mix Weights
C. CY 2019 Home Health Payment Rate Update
D. Rural Add-On Payments for CYs 2019 Through 2022
E. Payments for High-Cost Outliers Under the HH PPS
F. Implementation of the Patient-Driven Groupings Model (PDGM)
for CY 2020
G. Changes Regarding Certifying and Recertifying Patient
Eligibility for Medicare Home Health Services
H. The Role of Remote Patient Monitoring Under the Medicare Home
Health Benefit
IV. Home Health Value-Based Purchasing (HHVBP) Model
A. Background
B. Quality Measures
C. Performance Scoring Methodology
D. Update on the Public Display of Total Performance Scores
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. Removal Factors for Previously Adopted HH QRP Measures
D. Quality Measures Currently Adopted for the HH QRP
E. Removal of HH QRP Measures Beginning With the CY 2021 HH QRP
F. IMPACT Act Implementation Update
G. Form, Manner, and Timing of OASIS Data Submission
H. Policies Regarding Public Display for the HH QRP
I. Home Health Care Consumer Assessment of Healthcare Providers
and Systems[supreg] (HHCAHPS)
VI. Medicare Coverage of Home Infusion Therapy Services
A. General Background
B. Health and Safety Standards for Home Infusion Therapy
C. Approval and Oversight of Accrediting Organizations for Home
Infusion Therapy Suppliers
D. Payment for Home Infusion Therapy Services
VII. Changes to the Accreditation Requirements for Certain Medicare
Certified Providers and Suppliers
A. Background
B. Changes to Certain Requirements for Medicare-Certified
Providers and Suppliers at Part 488
VIII. Requests for Information
IX. Collection of Information Requirements
A. Wage Estimates
B. ICRs Regarding the OASIS
C. ICRs Regarding Home Infusion Therapy
D. ICRs Regarding the Approval and Oversight of Accrediting
Organizations for Home Infusion Therapy
X. 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) 2019, as required
under section 1895(b) of the Social Security Act (the Act). This rule
also updates the case-mix weights under sections 1895(b)(4)(A)(i) and
(b)(4)(B) of the Act for CY 2019. For home health services beginning on
or after January 1, 2020, this rule finalizes case-mix methodology
refinements, which eliminate the use of therapy thresholds for case-mix
adjustment purposes; and changes the unit of payment from a 60-day
episode of care to a 30-day period of care, as mandated by section
51001 of the Bipartisan Budget Act of 2018 (hereinafter referred to as
the ``BBA of 2018''). This final rule with comment period also:
Finalizes the methodology used to determine rural add-on payments for
CYs 2019 through 2022, as required by section 50208 of the BBA of 2018;
finalizes regulations text changes regarding certifying and
recertifying patient eligibility for Medicare home health services
under sections 1814(a) and 1835(a) of the Act; and finalizes our
proposal on how to define ``remote patient monitoring'' under the
Medicare home health benefit and include the costs of such monitoring
as an allowable administrative costs. Lastly, this rule finalizes
changes to the Home Health Value Based Purchasing (HHVBP) Model under
the authority of section 1115A of the Act, and the Home Health Quality
Reporting Program (HH QRP) requirements under the authority of section
1895(b)(3)(B)(v) of the Act.
2. Home Infusion Therapy Services
a. Payment for Home Infusion Therapy Services
This final rule with comment period establishes a transitional
payment for home infusion therapy services for CYs 2019 and 2020, as
required by section 50401 of the BBA of 2018. In addition, this rule
finalizes health and safety standards for home infusion therapy and an
accreditation and oversight process for qualified home infusion therapy
suppliers.
b. Safety Standards for Home Infusion Therapy Services
This final rule with comment period implements health and safety
standards for qualified home infusion therapy suppliers as required by
section 5012 of the 21st Century Cures Act. These standards provide a
foundation for ensuring patient safety and quality care by establishing
requirements for the plan of care to be initiated and updated by a
physician; 7-day-a-week, 24-hour-a-day access to services and remote
monitoring; and patient education and training regarding their home
infusion therapy care.
c. Accreditation of Home Infusion Therapy Suppliers
This final rule with comment period also implements regulations for
the approval and oversight of AOs that accredit home infusion therapy
suppliers.
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B. Summary of the Major Provisions
1. Home Health Prospective Payment System (HH PPS)
In the CY 2015 HH PPS final rule (79 FR 66072), we finalized our
proposal to recalibrate the case-mix weights every year with the most
current and complete data available at the time of rulemaking. In
section III.B. of this rule, we are recalibrating the HH PPS case-mix
weights, using the most current cost and utilization data available, in
a budget-neutral manner. In section III.C. of this rule, we are
finalizing the rebasing of the home health market basket and updates to
the payment rates under the HH PPS by the home health payment update
percentage of 2.2 percent (using the 2016-based Home Health Agency
(HHA) market basket update of 3.0 percent, minus 0.8 percentage point
for multifactor productivity) as required by section
1895(b)(3)(B)(vi)(I) of the Act. Also in section III.C. of this final
rule with comment period, we are finalizing a reduction in the labor-
related share from 78.5 to 76.1 percent of total costs on account of
the rebasing of the home health market basket. Lastly, in section
III.C. of this rule, we update the CY 2019 home health wage index using
FY 2015 hospital cost report data. In section III.D. of this final rule
with comment period, we are finalizing a methodology for applying rural
add-on payments for CYs 2019 through 2022, as required by section 50208
of the BBA of 2018. In section III.E. of this rule, we are finalizing a
reduction to the fixed-dollar loss ratio from 0.55 to 0.51 for CY 2019
in order to increase outlier payments as a percentage of total payments
so that this percentage is closer to, but no more than, 2.5 percent.
In section III.F. of this rule, we are finalizing case-mix
methodology refinements and a change in the unit of payment from a 60-
day episode of care to a 30-day period of care effective January 1,
2020 and in a budget neutral manner, as required by section 51001 of
the BBA of 2018. The ``Patient-Driven Groupings Model'', or 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 51001(a)(3) of the BBA of 2018, that are currently used to
case-mix adjust payments under the HH PPS.
In section III.G. of this rule, we are finalizing regulation text
changes at 42 CFR 424.22(b)(2) to eliminate the requirement that the
certifying physician must estimate how much longer skilled services
will be needed as part of the recertification statement. In addition,
in section III.G of this rule, consistent with section 51002 of the BBA
of 2018, we are finalizing a proposal to align the regulations text at
Sec. 424.22(c) with current subregulatory guidance to allow medical
record documentation from the HHA to be used to support the basis for
certification and/or recertification of home health eligibility, if
certain requirements are met.
In section III.H. of this rule, we are finalizing our proposal to
define ``remote patient monitoring'' under the Medicare home health
benefit and changes to the regulations at Sec. 409.46 to include costs
of remote patient monitoring as allowable administrative costs.
2. Home Health Value Based Purchasing
In section IV. of this final rule with comment period, we are
finalizing changes to the Home Health Value Based Purchasing (HHVBP)
Model implemented January 1, 2016. Specifically, we are finalizing,
beginning with performance year (PY) 4, the following policy changes:
removal of two Outcome and Assessment Information Set (OASIS) based
measures, Influenza Immunization Received for Current Flu Season and
Pneumococcal Polysaccharide Vaccine Ever Received, from the set of
applicable measures; replacement of three OASIS-based measures
(Improvement in Ambulation-Locomotion, Improvement in Bed Transferring,
and Improvement in Bathing) with two new composite measures on total
normalized composite change in self-care and mobility; changes to how
we calculate the Total Performance Scores by changing the weighting
methodology for the OASIS-based, claims-based, and HHCAHPS measures;
and a change to the scoring methodology by reducing the maximum amount
of improvement points an HHA can earn, from 10 points to 9 points. We
are also providing an update on the progress towards developing public
reporting of performance under the HHVBP Model and providing a summary
of public comments received in response to our solicitation of feedback
on what information we should consider making publicly available in the
future.
3. Home Health Quality Reporting Program
In section V. of this final rule with comment period, we are
finalizing updates to our the Home Health (HH) Quality Reporting
Program (QRP) by adopting eight measure removal factors, removing seven
measures, and updating our regulations to clarify that not all OASIS
data are required for the HH QRP. We are also providing an update on
the implementation of certain provisions of the IMPACT Act, and are
finalizing our proposal to increase the number of years of data used to
calculate the Medicare Spending per Beneficiary measure for purposes of
display from 1 year to 2 years.
4. Home Infusion Therapy
In section VI.A. of this final rule with comment period, we discuss
general background of home infusion therapy services and how this
relates to the implementation of the new home infusion benefit. In
section VI.B. of this final rule with comment period, we have finalized
the addition of a new subpart I under the regulations at 42 CFR part
486 to incorporate health and safety requirements for home infusion
therapy suppliers. These regulations provide a framework for CMS to
approve home infusion therapy accreditation organizations. Subpart I
includes General Provisions (Scope and Purpose, and Definitions) and
Standards for Home Infusion Therapy (Plan of Care and Required
Services). Section VI.D. of this final rule with comment period
provides information on temporary transitional payments for home
infusion therapy services for CYs 2019 and 2020 as mandated by section
50401 of the BBA of 2018, and responds to the comments received
regarding issues such as the regulatory definition of ``Infusion Drug
Administration Calendar Day.''
In section VI.C. of this final rule with comment period, we discuss
the requirements set forth in section 1861(iii)(3)(D)(III) of the Act,
which mandates that suppliers of home infusion therapy receive
accreditation from a CMS-approved accrediting organization (AO) in
order to receive Medicare payment. The Secretary must designate AOs to
accredit suppliers furnishing home infusion therapy not later than
January 1, 2021. Qualified home infusion therapy suppliers are required
to receive accreditation before receiving Medicare payment for services
provided to Medicare beneficiaries.
Until now, no regulations have addressed the following elements of
CMS' approval and oversight of the AOs that accredit suppliers of home
infusion therapy: (1) The required components to be included in a home
infusion therapy AO's initial or renewal accreditation program
application; (2) regulations related to CMS' review and approval of the
home infusion therapy AOs application for approval of its accreditation
program; and (3) the
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ongoing monitoring and oversight of CMS approved home infusion therapy
AOs. However, this final rule with comment period finalizes a set of
regulations that will govern the CMS approval and oversight process for
all home infusion therapy AOs.
In this final rule with comment period, we are not finalizing our
proposal to modify 42 CFR 488.5 by adding a requirement that all
surveyors, that work for AOs that accredit Medicare certified providers
and suppliers, must complete the relevant program specific CMS online
trainings.
However, in this final rule with comment period, we are finalizing
the proposed requirement to be added at Sec. 488.5 which requires the
AOs for Medicare certified providers and suppliers to provide a written
statement with their application stating that if a fully accredited
facility deemed to be in good-standing provides written notification
that they wish to voluntarily withdraw from the AO's CMS-approved
accreditation program, the AO must continue the facility's current
accreditation until the effective date of withdrawal identified by the
facility or the expiration date of the term of accreditation, whichever
comes first.
C. Summary of Costs, Transfers, and Benefits
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
D. Improving Patient Outcomes and Reducing Burden Through Meaningful
Measures
In the CY 2019 HH PPS proposed rule, we stated that regulatory
reform and reducing regulatory burden are high priorities for us. To
reduce the regulatory burden on the healthcare industry, lower health
care costs, and enhance patient care, in October 2017, we launched the
Meaningful Measures Initiative.\1\ This initiative is one component of
our agency-wide Patients Over Paperwork Initiative \2\ which is aimed
at evaluating and streamlining regulations with a goal to reduce
unnecessary cost and burden, increase efficiencies, and improve
beneficiary experience. The Meaningful Measures Initiative is aimed at
identifying the highest priority areas for quality
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measurement and quality improvement in order to assess the core quality
of care issues that are most vital to advancing our work to improve
patient outcomes. The Meaningful Measures Initiative represents a new
approach to quality measures that fosters operational efficiencies, and
will reduce costs including, the collection and reporting burden while
producing quality measurement that is more focused on meaningful
outcomes.
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\1\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
\2\ See Remarks by Administrator Seema Verma at the Health Care
Payment Learning and Action Network (LAN) Fall Summit, as prepared
for delivery on October 30, 2017 https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
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The Meaningful Measures Framework has the following objectives:
Address high-impact measure areas that safeguard public
health;
Patient-centered and meaningful to patients;
Outcome-based where possible;
Fulfill each program's statutory requirements;
Minimize the level of burden for health care providers
(for example, through a preference for EHR-based measures where
possible, such as electronic clinical quality measures);
Provide significant opportunity for improvement;
Address measure needs for population based payment through
alternative payment models; and
Align across programs and/or with other payers.
In order to achieve these objectives, stated in the proposed rule
that we had identified 19 Meaningful Measures areas and mapped them to
six overarching quality priorities as shown in Table 2:
[GRAPHIC] [TIFF OMITTED] TR13NO18.002
By including Meaningful Measures in our programs, we stated our
belief that we can also address the following cross-cutting measure
criteria:
Eliminating disparities;
Tracking measurable outcomes and impact;
Safeguarding public health;
Achieving cost savings;
Improving access for rural communities; and
Reducing burden.
We also stated the we believe that the Meaningful Measures
Initiative will improve outcomes for patients, their families, and
health care providers while reducing burden and costs for clinicians
and providers and promoting operational efficiencies.
II. Background
A. Statutory Background
1. Home Health Prospective Payment System
a. 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 requires 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 requires 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
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of the 2000 final rule), and (2) the standardized prospective payment
amount be adjusted to account for the effects of case-mix and wage
levels among HHAs.
Section 1895(b)(3)(B) of the Act requires the standard prospective
payment amounts be annually updated by the home health applicable
percentage increase. Section 1895(b)(4) of the Act governs the payment
computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act
require the standard prospective payment amount to be adjusted for
case-mix and geographic differences in wage levels. Section
1895(b)(4)(B) of the Act requires the establishment of an appropriate
case-mix change adjustment factor for significant variation in costs
among different units of services.
Similarly, section 1895(b)(4)(C) of the Act requires the
establishment of 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 65884, 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, to be 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 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. Updates to the Home Health Prospective Payment System
As required by section 1895(b)(3)(B) of the Act, we have
historically updated the HH PPS rates annually in the Federal Register.
The August 29, 2007
[[Page 56413]]
final rule with comment period set forth an update to the 60-day
national episode rates and the national per-visit rates under the HH
PPS for CY 2008. The CY 2008 HH PPS final rule included an analysis
performed on CY 2005 home health claims data, which indicated a 12.78
percent increase in the observed case-mix since 2000. Case-mix
represents the variations in conditions of the patient population
served by the HHAs. Subsequently, a more detailed analysis was
performed on the 2005 case-mix data to evaluate if any portion of the
12.78 percent increase was associated with a change in the actual
clinical condition of home health patients. We identified 8.03 percent
of the total case-mix change as real, and therefore, decreased the
12.78 percent of total case-mix change by 8.03 percent to get a final
nominal case-mix increase measure of 11.75 percent (0.1278 * (1-0.0803)
= 0.1175).
To account for the changes in case-mix that were not related to an
underlying change in patient health status, we implemented a reduction,
over 4 years, to the national, standardized 60-day episode payment
rates. That reduction was to be 2.75 percent per year for 3 years
beginning in CY 2008 and 2.71 percent for the fourth year in CY 2011.
In the CY 2011 HH PPS final rule (76 FR 68532), we updated our analyses
of case-mix change and finalized a reduction of 3.79 percent, instead
of 2.71 percent, for CY 2011 and deferred finalizing a payment
reduction for CY 2012 until further study of the case-mix change data
and methodology was completed.
In the CY 2012 HH PPS final rule (76 FR 68526), we updated the 60-
day national episode rates and the national per-visit rates. In
addition, as discussed in the CY 2012 HH PPS final rule (76 FR 68528),
our analysis indicated that there was a 22.59 percent increase in
overall case-mix from 2000 to 2009 and that only 15.76 percent of that
overall observed case-mix percentage increase was due to real case-mix
change. As a result of our analysis, we identified a 19.03 percent
nominal increase in case-mix. At that time, to fully account for the
19.03 percent nominal case-mix growth identified from 2000 to 2009, we
finalized a 3.79 percent payment reduction in CY 2012 and a 1.32
percent payment reduction for CY 2013.
In the CY 2013 HH PPS final rule (77 FR 67078), we implemented the
1.32 percent reduction to the payment rates for CY 2013 finalized the
previous year, to account for nominal case-mix growth from 2000 through
2010. When taking into account the total measure of case-mix change
(23.90 percent) and the 15.97 percent of total case-mix change
estimated as real from 2000 to 2010, we obtained a final nominal case-
mix change measure of 20.08 percent from 2000 to 2010 (0.2390 * (1-
0.1597) = 0.2008). To fully account for the remainder of the 20.08
percent increase in nominal case-mix beyond that which was accounted
for in previous payment reductions, we estimated that the percentage
reduction to the national, standardized 60-day episode rates for
nominal case-mix change would be 2.18 percent. Although we considered
proposing a 2.18 percent reduction to account for the remaining
increase in measured nominal case-mix, we finalized the 1.32 percent
payment reduction to the national, standardized 60-day episode rates in
the CY 2012 HH PPS final rule (76 FR 68532). Section 3131(a) of the
Affordable Care Act added new section 1895(b)(3)(A)(iii) to the Act,
which required that, beginning in CY 2014, we apply an adjustment to
the national, standardized 60-day episode rate and other amounts that
reflect factors such as changes in the number of visits in an episode,
the mix of services in an episode, the level of intensity of services
in an episode, the average cost of providing care per episode, and
other relevant factors. Additionally, we were required to phase in any
adjustment over a 4-year period in equal increments, not to exceed 3.5
percent of the payment amount (or amounts) as of the date of enactment
of the Affordable Care Act in 2010, and fully implement the rebasing
adjustments by CY 2017. Therefore, in the CY 2014 HH PPS final rule (78
FR 72256) for each year, CY 2014 through CY 2017, we finalized a fixed-
dollar reduction to the national, standardized 60-day episode payment
rate of $80.95 per year, increases to the national per-visit payment
rates per year, and a decrease to the NRS conversion factor of 2.82
percent per year. We also finalized three separate LUPA add-on factors
for skilled nursing, physical therapy, and speech-language pathology
and removed 170 diagnosis codes from assignment to diagnosis groups in
the HH PPS Grouper. In the CY 2015 HH PPS final rule (79 FR 66032), we
implemented the second year of the 4-year phase-in of the rebasing
adjustments to the HH PPS payment rates and made changes to the HH PPS
case-mix weights. In addition, we simplified the face-to-face encounter
regulatory requirements and the therapy reassessment timeframes.
In the CY 2016 HH PPS final rule (80 FR 68624), we implemented the
third year of the 4-year phase-in of the rebasing adjustments to the
national, standardized 60-day episode payment amount, the national per-
visit rates and the NRS conversion factor (as discussed previously). In
the CY 2016 HH PPS final rule, we also recalibrated the HH PPS case-mix
weights, using the most current cost and utilization data available, in
a budget-neutral manner and finalized reductions to the national,
standardized 60-day episode payment rate in CY 2016, CY 2017, and CY
2018 of 0.97 percent in each year to account for estimated case-mix
growth unrelated to increases in patient acuity (that is, nominal case-
mix growth) between CY 2012 and CY 2014. Finally, section 421(a) of the
MMA, as amended by section 210 of the MACRA, extended the payment
increase of 3 percent for HH services provided in rural areas (as
defined in section 1886(d)(2)(D) of the Act) to episodes or visits
ending before January 1, 2018.
In the CY 2017 HH PPS final rule (81 FR 76702), we implemented the
last year of the 4-year phase-in of the rebasing adjustments to the
national, standardized 60-day episode payment amount, the national per-
visit rates and the NRS conversion factor (as outlined previously). We
also finalized changes to the methodology used to calculate outlier
payments under the authority of section 1895(b)(5) of the Act. Lastly,
in accordance with section 1834(s) of the Act, as added by section
504(a) of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113,
enacted December 18, 2015), we implemented changes in payment for
furnishing Negative Pressure Wound Therapy (NPWT) using a disposable
device for patients under a home health plan of care for which payment
would otherwise be made under section 1895(b) of the Act.
2. Home Infusion Therapy
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 therapy and home
infusion drugs furnished by a qualified home infusion therapy supplier.
This benefit will ensure consistency in coverage for home infusion
benefits for all Medicare beneficiaries. Section 50401 of the BBA of
2018 amended section 1834(u) of the
[[Page 56414]]
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 cost of
the same items and services, as defined in section 1861(iii)(2)(A) and
(B) of the Act, related to the administration of home infusion drugs.
The temporary transitional payment would begin on January 1, 2019 and
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.
Home infusion therapy is a treatment option for patients with a
wide range of acute and chronic conditions, ranging from bacterial
infections to more complex conditions such as late-stage heart failure
and immune deficiencies. Home infusion therapy affords a patient
independence and better quality of life, because it is provided in the
comfort of the patient's home at a time that best fits his or her
needs. This is significant, because generally patients can return to
their daily activities after they receive their infusion treatments
and, in many cases, they can continue their activities while receiving
their treatments. In addition, home infusion therapy can provide
improved safety and better outcomes. The home has been shown to be a
safe setting for patients to receive infusion therapy.\3\ Additionally,
patients receiving treatment outside of the hospital setting may be at
lower risk of hospital-acquired infections, which can be more difficult
to treat because of multidrug resistance than those that are community-
acquired. This is particularly important for vulnerable patients such
as those who are immunocompromised, as hospital-acquired infections are
increasingly caused by antibiotic-resistant pathogens.
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\3\ Bhole, M.V., Burton, J., & Chapel, H.M., (2008). Self-
infusion programs for immunoglobulin replacement at home:
Feasibility, safety and efficacy. Immunology and Allergy Clinics of
North America, 28(4), 821-832. doi:10.1016/j.iac.2008.06.005.
Souayah, N., Hasan, A., Khan, H., et al. (2011). The safety
profile of home infusion of intravenous immunoglobulin in patients
with neuroimmunologic disorders. Journal of Clinical Neuromuscular
Disease, 12(supp 4), S1-10. doi: 10.1097/CND.0b013e3182212589.
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Infusion therapy typically means that a drug is administered
intravenously, but the term may also refer to situations where drugs
are provided through other non-oral routes, such as intramuscular
injections and epidural routes (into the membranes surrounding the
spinal cord). Diseases that may require infusion therapy include
infections that are unresponsive to oral antibiotics, cancer and
cancer-related pain, dehydration, and gastrointestinal diseases or
disorders which prevent normal functioning of the gastrointestinal
system. Other conditions treated with specialty infusion therapies may
include some forms of cancers, congestive heart failure, Crohn's
Disease, hemophilia, hepatitis, immune deficiencies, multiple sclerosis
and rheumatoid arthritis. Infusion therapy originates with a
prescription order from a physician or another qualified prescriber who
is overseeing the care of the patient. The prescription order is sent
to a home infusion therapy supplier, which is a state-licensed
pharmacy, physician, or other provider of services or suppliers
licensed by the state.
A 2010 Government Accountability Office (GAO) report (10-426) found
that most health insurers rely on credentialing, accreditation, or both
to help ensure that plan members receive quality home infusion services
from their network suppliers.\4\ Home infusion AOs conduct on-site
surveys to evaluate all components of the service, including medical
equipment, nursing, and pharmacy. Accreditation standards can include
such requirements as the CMS Conditions of Participation for home
health services, other Federal government regulations, and industry
best practices. All of the accreditation standards evaluate a range of
provider competencies, such as having a complete plan of care, response
to adverse events, and implementation of a quality improvement plan.
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\4\ https://www.gao.gov/assets/310/305261.pdf.
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Sections 1861(iii)(3)(D)(III) and 1834(u)(5) of the Act, as amended
by section 5012 of the Cures Act requires that, in order to participate
in Medicare, home infusion therapy suppliers must select a CMS-approved
AO and undergo an accreditation review process to demonstrate that the
home infusion therapy program meets the accreditation organization's
standards. Section 1861(iii) of the Act, as amended by section 5012 of
the Cures Act, sets forth standards in three areas: (1) Ensuring that
all patients have a plan of care established and updated by a physician
that sets out the care and prescribed infusion therapy necessary to
meet the patient-specific needs; (2) having procedures to ensure that
remote monitoring services associated with administering infusion drugs
in a patient's home are provided; and (3) having procedures to ensure
that patients receive education and training on the effective use of
medications and equipment in the home.
III. Provisions of the Proposed Rule: Payment Under the Home Health
Prospective Payment System (HH PPS) and Responses to Comments
In the July 12, 2018 Federal Register (83 FR 32340 through 32522),
we published the proposed rule titled ``Medicare and Medicaid Programs;
CY 2019 Home Health Prospective Payment System Rate Update and CY 2020
Case-Mix Adjustment Methodology Refinements; Home Health Value-Based
Purchasing Model; Home Health Quality Reporting Requirements; Home
Infusion Therapy Requirements; and Training Requirements for Surveyors
of National Accrediting Organizations''. We received approximately
1,125 timely comments from the public, including comments from home
health agencies, home infusion therapy providers, DME suppliers,
manufacturers of remote patient monitoring technology, national and
state provider associations, patient and other advocacy organizations,
physicians, nurses, therapists, pharmacists, and accrediting
organizations. In the following sections, we summarize the proposed
provisions and the public comments, and provide the responses to
comments.
A. Monitoring for Potential Impacts--Affordable Care Act Rebasing
Adjustments
In the CY 2019 proposed rule (83 FR 32348), we provided a summary
of analysis on fiscal (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. In addition, we presented information
on Medicare home health utilization statistics and trends that included
HHA claims data through CY 2017. We will continue monitoring the
impacts due to the rebasing adjustments and other policy changes and
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.
B. CY 2019 HH PPS Case-Mix Weights
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. To recalibrate the HH PPS case-mix weights for CY 2019,
we will use the same methodology finalized in the CY 2008
[[Page 56415]]
HH PPS final rule (72 FR 49762), the CY 2012 HH PPS final rule (76 FR
68526), and the CY 2015 HH PPS final rule (79 FR 66032). 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.
To generate the final CY 2019 HH PPS case-mix weights, we used CY
2017 home health claims data (as of June 30, 2018) with linked OASIS
data. These data are the most current and complete data available at
this time. We noted in the proposed rule that we would use CY 2017 home
health claims data (as of June 30, 2018 or later) with linked OASIS
data to generate the CY 2019 HH PPS case-mix weights for this final
rule with comment period. The process we used to calculate the HH PPS
case-mix weights is outlined in this section.
Step 1: Re-estimate the four-equation model to determine the
clinical and functional points for an episode using wage-weighted
minutes of care as our dependent variable for resource use. The wage-
weighted minutes of care are determined using the CY 2016 Bureau of
Labor Statistics national hourly wage plus fringe rates for the six
home health disciplines and the minutes per visit from the claim. The
points for each of the variables for each leg of the model, updated
with CY 2017 home health claims data, are shown in Table 3. The points
for the clinical variables are added together to determine an episode's
clinical score. The points for the functional variables are added
together to determine an episode's functional score.
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In updating the four-equation model for CY 2019, using 2017 home
health claims data (the last update to the four-equation model for CY
2018 used CY 2016 home health claims data), there were few changes to
the point values for the variables in the four-equation model. These
relatively minor changes reflect the change in the relationship between
the grouper variables and resource use between CY 2016 and CY 2017. The
final CY 2019 four-equation model resulted in 119 point-giving
variables being used in the model (as compared to the 119 variables for
the CY 2018 recalibration, which can be found in Table 2 of the CY 2018
HH PPS final rule (82 FR 51684)). There were 9 variables that were
added to the model due to the presence of additional resources
associated with those variables and 9 variables that were dropped from
the model due to the absence of additional resources associated with
those variables. Of the variables that were in both the four-equation
model for CY 2019 and the four-equation model for CY 2018, the points
for 7 variables increased in the CY 2019 four-equation model and the
points for 68 variables decreased in the CY 2019 4-equation model.
There were 35 variables with the same point values.
Step 2: Redefining the clinical and functional thresholds so they
are reflective of the new points associated with the CY 2019 four-
equation model. After estimating the points for each of the variables
and summing the clinical and functional points for each episode, we
look at the distribution of the clinical score and functional score,
breaking the episodes into different steps. The categorizations for the
steps are as follows:
Step 1: First and second episodes, 0-13 therapy visits.
Step 2.1: First and second episodes, 14-19 therapy visits.
Step 2.2: Third episodes and beyond, 14-19 therapy visits.
Step 3: Third episodes and beyond, 0-13 therapy visits.
Step 4: Episodes with 20+ therapy visits.
Then, we divide the distribution of the clinical score for episodes
within a step such that a third of episodes are classified as low
clinical score, a third of episodes are classified as medium clinical
score, and a third of episodes are classified as high clinical score.
The same approach is then done looking at the functional score. It was
not always possible to evenly divide the episodes within each step into
thirds due to many episodes being clustered around one particular
score.\5\
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\5\ For Step 1, 33.7 percent of episodes were in the medium
functional level (All with score 13). For Step 2.1, 86.7% of
episodes were in the low functional level (Most with scores 6 to 7).
For Step 2.2, 81.5 percent of episodes were in the low functional
level (Most with score 0). For Step 3, 46.6 percent of episodes were
in the medium functional level (Most with score 9). For Step 4, 33.2
percent of episodes were in the medium functional level (Most with
score 6).
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Also, we looked at the average resource use associated with each
clinical and functional score and used that as a guide for setting our
thresholds. We grouped scores with similar average resource use within
the same level (even if it meant that more or less than a third of
episodes were placed within a level). The new thresholds, based off the
final CY 2019 four-equation model points are shown in Table 4.
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Step 3: Once the clinical and functional thresholds are determined
and each episode is assigned a clinical and functional level, the
payment regression is estimated with an episode's wage-weighted minutes
of care as the dependent variable. Independent variables in the model
are indicators for the step of the episode as well as the clinical and
functional levels within each step of the episode. Like the four-
equation model, the payment regression model is also estimated with
robust standard errors that are clustered at the beneficiary level.
Table 5 shows the regression coefficients for the variables in the
payment regression model updated with CY 2017 home health claims data.
The R-squared value for the final CY 2019 payment regression model is
0.5429 (an increase from 0.5095 for the CY 2018 recalibration).
[[Page 56420]]
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Step 4: We use the coefficients from the payment regression model
to predict each episode's wage-weighted minutes of care (resource use).
We then divide these predicted values by the mean of the dependent
variable (that is, the average wage- weighted minutes of care across
all episodes used in the payment regression). This division constructs
the weight for each episode, which is simply the ratio of the episode's
predicted wage-weighted minutes of care divided by the average wage-
weighted minutes of care in the sample. Each episode is then aggregated
into one of the 153 home health resource groups (HHRGs) and the ``raw''
weight for each HHRG was calculated as the average of the episode
weights within the HHRG.
Step 5: The raw weights associated with 0 to 5 therapy visits are
then increased by 3.75 percent, the weights associated with 14-15
therapy visits are decreased by 2.5 percent, and the weights associated
with 20+ therapy visits are decreased by 5 percent. These adjustments
to the case-mix weights were finalized in the CY 2012 HH PPS final rule
(76 FR 68557) and were done to address concerns that the HH PPS over-
values therapy episodes and undervalues non-therapy episodes and to
better align the case-mix weights with episode costs estimated from
cost report data.\6\
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\6\ Medicare Payment Advisory Commission (MedPAC), Report to
Congress: Medicare Payment Policy. March 2011, page 176.
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Step 6: After the adjustments in step 5 are applied to the raw
weights, the weights are further adjusted to create an increase in the
payment weights for the therapy visit steps between the therapy
thresholds. Weights with the same clinical severity level, functional
severity level, and early/later episode status were grouped together.
Then within those groups, the weights for each therapy step between
thresholds are gradually increased. We do this by interpolating between
the main thresholds on the model (from 0-5 to 14-15 therapy visits, and
from 14-15 to 20+ therapy visits). We use a linear model to implement
the interpolation so the payment weight increase for each step between
the thresholds (such as the increase between 0-5 therapy visits and 6
therapy visits and the increase between 6 therapy visits and 7-9
therapy visits) are constant. This interpolation is identical to the
process finalized in the CY 2012 HH PPS final rule (76 FR 68555).
[[Page 56421]]
Step 7: The interpolated weights are then adjusted so that the
average case-mix for the weights is equal to 1.0000.\7\ This last step
creates the CY 2019 case-mix weights shown in Table 6.
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\7\ When computing the average, we compute a weighted average,
assigning a value of one to each normal episode and a value equal to
the episode length divided by 60 for PEPs.
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To ensure the changes to the HH PPS case-mix weights are
implemented in a budget neutral manner, we then apply a case-mix budget
neutrality factor to the CY 2019 national, standardized 60-day episode
payment rate (see section III.C.3. of this final rule with comment
period). The case-mix budget neutrality factor is calculated as the
ratio of total payments when the CY 2019 HH PPS case-mix weights
(developed using CY 2017 home health claims data) are applied to CY
2017 utilization (claims) data to total payments when CY 2018 HH PPS
case-mix weights (developed using CY 2016 home health claims data) are
applied to CY 2017 utilization data. This produces a case-mix budget
neutrality factor for CY 2019 of 1.0169.
The following is a summary of the comments received and our
responses to comments on the CY 2019 HH PPS case-mix weights.
Comment: Some commenters believe that CMS should not recalibrate
the case-mix weights for CY 2019 because annual changes are too
frequent. Other commenters indicated that CMS should provide more
detail on how the recalibration works and why the model is recalibrated
every year.
Response: As stated in the CY 2019 HH PPS proposed rule (83 FR
32340), the methodology used to recalibrate the weights is identical to
the methodology used in the CY 2012 recalibration except for the minor
exceptions as noted in the CY 2015 HH PPS proposed and final rules (79
FR 38366 and 79 FR 66032, respectively). In the CY 2015 HH PPS final
rule, we finalized annual recalibration and the methodology to be used
for each year's recalibration (79 FR 66072). As stated in the CY 2019
HH PPS proposed rule (83 FR 32353), 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. For more detail, we also encourage commenters to
refer to the CY 2012 HH PPS proposed and final rules (76 FR 40988 and
76 FR 68526, respectively) and the November 1, 2011 ``Revision of the
Case-Mix Weights for the HH PPS Report'' on our home page at: https://www.cms.gov/center/provider-Type/home-Health-AgencyHHA-Center.html for
additional information about the recalibration methodology. We note
that in comparing the final CY 2019 HH PPS case-mix weights (see Table
6) to the final CY 2018 HH PPS case-mix weights (82 FR 51676), the
case-mix weights change very little, with most case-mix weights either
increasing or decreasing by 1 to 2 percent with no case-mix weights
increasing by more than 3 percent or decreasing by more than 3 percent.
Aggregate increases or decreases in the case-mix weights are offset by
the case-mix budget neutrality factor, which is applied to the
national, standardized 60-day episode payment rate. In other words,
although the case-mix weights themselves may increase or decrease from
year-to-year, we correspondingly offset any estimated increases or
decreases in total payments under the HH PPS, as a result of the case-
mix recalibration, by applying a budget neutrality factor to the
national, standardized 60-day episode payment rate. For CY 2019, the
case-mix budget neutrality factor will be 1.0169 as described
previously. The recalibration of the case-mix weights is not intended
to increase or decrease overall HH PPS payments, but rather is used to
update the relative differences in resource use amongst the 153 groups
in the HH PPS case-mix system to reflect current practice patterns.
Comment: Another commenter suggested that CMS should adjust for any
nominal case-mix changes observed between 2015 and 2017.
Response: We will continue to monitor real and nominal case-mix
growth and may propose additional
[[Page 56425]]
reductions for nominal case-mix growth, as needed, in the future.
Final Decision: We are finalizing the recalibrated scores for the
case-mix adjustment variables, clinical and functional thresholds,
payment regression model, and case-mix weights in Tables 3 through 6.
For this final rule with comment period, the CY 2019 scores for the
case-mix variables, the clinical and functional thresholds, and the
case-mix weights were developed using complete CY 2017 claims data as
of June 30, 2018. We note that we finalized the recalibration
methodology and the proposal to annually recalibrate the HH PPS case-
mix weights in the CY 2015 HH PPS final rule (79 FR 66072). No
additional proposals were made with regards to the recalibration
methodology in the CY 2019 HH PPS proposed rule.
C. CY 2019 Home Health Payment Rate Update
1. Rebasing and Revising of the Home Health Market Basket
a. Background
Section 1895(b)(3)(B) of the Act requires that the standard
prospective payment amounts for CY 2019 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. Effective for cost
reporting periods beginning on or after July 1, 1980, we developed and
adopted an HHA input price index (that is, the home health ``market
basket''). Although ``market basket'' technically describes the mix of
goods and services used to produce home health care, this term is also
commonly used to denote the input price index derived from that market
basket. Accordingly, the term ``home health market basket'' used in
this document refers to the HHA input price index.
The percentage change in the home health market basket reflects the
average change in the price of goods and services purchased by HHAs in
providing an efficient level of home health care services. We first
used the home health market basket to adjust HHA cost limits by an
amount that reflected the average increase in the prices of the goods
and services used to furnish reasonable cost home health care. This
approach linked the increase in the cost limits to the efficient
utilization of resources. For a greater discussion on the home health
market basket, see the notice with comment period published in the
February 15, 1980 Federal Register (45 FR 10450 and 10451), the notice
with comment period published in the February 14, 1995 Federal Register
(60 FR 8389 through 8392), and the notice with comment period published
in the July 1, 1996 Federal Register (61 FR 34344 through 34347).
Beginning with the FY 2002 HHA PPS payments, we used the home health
market basket to update payments under the HHA PPS. We last rebased the
home health market basket effective with the CY 2013 update (77 FR
67081).
The home health market basket is a fixed-weight, Laspeyres-type
price index. A Laspeyres-type price index measures the change in price,
over time, of the same mix of goods and services purchased in the base
period. Any changes in the quantity or mix of goods and services (that
is, intensity) purchased over time are not measured.
The index itself is constructed in three steps. First, a base
period is selected (in this final rule with comment period, we are
using 2016 as the base period) and total base period expenditures are
estimated for a set of mutually exclusive and exhaustive spending
categories, with the proportion of total costs that each category
represents being calculated. These proportions are called ``cost
weights'' or ``expenditure weights.'' Second, each expenditure category
is matched to an appropriate price or wage variable, referred to as a
``price proxy.'' In almost every instance, these price proxies are
derived from publicly available statistical series that are published
on a consistent schedule (preferably at least on a quarterly basis).
Finally, the expenditure weight for each cost category is multiplied by
the level of its respective price proxy. The sum of these products
(that is, the expenditure weights multiplied by their price index
levels) for all cost categories yields the composite index level of the
market basket in a given period. Repeating this step for other periods
produces a series of market basket levels over time. Dividing an index
level for a given period by an index level for an earlier period
produces a rate of growth in the input price index over that timeframe.
As noted previously, the market basket is described as a fixed-
weight index because it represents the change in price over time of a
constant mix (quantity and intensity) of goods and services needed to
provide HHA services. The effects on total expenditures resulting from
changes in the mix of goods and services purchased subsequent to the
base period are not measured. For example, a HHA hiring more nurses to
accommodate the needs of patients would increase the volume of goods
and services purchased by the HHA, but would not be factored into the
price change measured by a fixed-weight home health market basket. Only
when the index is rebased would changes in the quantity and intensity
be captured, with those changes being reflected in the cost weights.
Therefore, we rebase the market basket periodically so that the cost
weights reflect recent changes in the mix of goods and services that
HHAs purchase (HHA inputs) to furnish inpatient care between base
periods.
Comment: A commenter had concerns that the data used for the market
rebasing does not reflect current costs.
Response: For the 2016-based home health market basket, we use the
2016 Medicare cost reports for freestanding HHAs (CMS Form 1728-94) as
the primary data source; the 2016 data are the most recent and
comprehensive set of cost report data available to CMS at the time of
rebasing. As we discussed in the CY 2019 HH PPS proposed rule (83 FR
32361), we use data from freestanding HHAs, which account for over 90
percent of HHAs (82 FR 35383), because we have determined that they
better reflect HHAs' actual cost structure. Expense data for hospital-
based HHAs can be affected by the allocation of overhead costs over the
entire institution. The 2010-based home health market basket was
primarily based on the 2010 Medicare cost report data. Therefore, we
believe that rebasing the home health market basket alleviates the
concerns that the market basket does not reflect the most current
costs.
b. Rebasing and Revising the Home Health Market Basket
We believe that it is desirable to rebase the home health market
basket periodically so that the cost category weights reflect changes
in the mix of goods and services that HHAs purchase in furnishing home
health care. We based the cost category weights in the current home
health market basket on CY 2010 data. We proposed 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.
The terms ``rebasing'' and ``revising,'' while often used
interchangeably, denote different activities. The term ``rebasing''
means moving the base year for the structure of costs of an input price
index (that is, in this exercise, we moved the base year cost structure
from CY 2010 to CY 2016) without making any other major changes to the
methodology. The term ``revising'' means changing data sources, cost
[[Page 56426]]
categories, and/or price proxies used in the input price index.
For this rebasing and revising, we rebased the detailed wages and
salaries and benefits cost weights to reflect 2016 BLS Occupational
Employment Statistics (OES) data for HHAs. The 2010-based home health
market basket used 2010 BLS OES data for HHAs. We also proposed to
break out the All Other (residual) cost category weight into more
detailed cost categories, based on the 2007 Benchmark U.S. Department
of Commerce, Bureau of Economic Analysis (BEA) Input-Output (I-O) Table
for HHAs. The 2010-based home health market basket used the 2002 I-O
data. Finally, due to its small weight, we proposed to eliminate the
cost category `Postage' and include these expenses in the `All Other
Services' cost weight.
Comment: Another commenter supported the rebasing of the home
health market basket.
Response: We appreciate the commenter's support.
c. Derivation of the 2016-Based Home Health Market Basket Cost Weights
The major cost weights for this revised and rebased home health
market basket are derived from the Medicare cost reports (MCR; CMS Form
1728-94) data for freestanding HHAs whose cost reporting period began
on or after October 1, 2015 and before October 1, 2016. Of the 2016
Medicare cost reports for freestanding HHAs, approximately 84 percent
of the reports had a begin date on January 1, 2016, approximately 6
percent had a begin date on July 1, 2016, and approximately 4 percent
had a begin date on October 1, 2015. Using this methodology allowed our
sample to include HHAs with varying cost report years including, but
not limited to, the Federal fiscal or calendar year. We referred to the
market basket as a calendar year market basket because the base period
for all price proxies and weights are set to CY 2016.
We maintained our policy of using data from freestanding HHAs (77
FR 67081), which account for over 90 percent of HHAs (82 FR 35383),
because we have determined that they better reflect HHAs' actual cost
structure. Expense data for hospital-based HHAs can be affected by the
allocation of overhead costs over the entire institution.
We derived eight major expense categories (Wages and Salaries,
Benefits, Contract Labor, Transportation, Professional Liability
Insurance (PLI), Fixed Capital, Movable Capital, and a residual ``All
Other'') from the 2016 Medicare HHA cost reports. Due to its small
weight, we eliminated the cost category `Postage' and included these
expenses in the ``All Other (residual)'' cost weight. These major
expense categories are based on those cost centers that are
reimbursable under the HHA PPS, specifically Skilled Nursing Care,
Physical Therapy, Occupational Therapy, Speech Pathology, Medical
Social Services, Home Health Aide, and Supplies. These are the same
cost centers that were used in the 2014 base payment rebasing (78 FR
72276), which are described in the Abt Associates Inc. June 2013,
Technical Paper, ``Analyses In Support of Rebasing and Updating
Medicare Home Health Payment Rates'' (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/Analyses-in-Support-of-Rebasing-and-Updating-the-Medicare-Home-Health-Payment-Rates-Technical-Report.pdf). Total costs for the HHA PPS reimbursable
services reflect overhead allocation. We provide detail on the
calculations for each major expense category.
1. Wages and Salaries: Wages and Salaries costs reflect direct
patient care wages and salaries costs as well as wages and salaries
costs associated with Plant Operations and Maintenance, Transportation,
and Administrative and General. Specifically, we calculated Wages and
Salaries by summing costs from Worksheet A, column 1, lines 3 through
12 and subtracting line 5.03 (A&G nonreimbursable costs).
2. Benefits: Benefits costs reflect direct patient care benefit
costs as well as benefit costs associated with Plant Operations and
Maintenance, Transportation, and Administrative and General.
Specifically, we calculated Benefits by summing costs from Worksheet A,
column 2, lines 3 through 12 and subtracting line 5.03 (A&G
nonreimbursable costs).
3. Direct Patient Care Contract Labor: Contract Labor costs reflect
direct patient care contract labor. Specifically, we calculated
Contract Labor by summing costs from Worksheet A, column 4, lines 6
through 11.
4. Transportation: Transportation costs reflect direct patient care
costs as well as transportation costs associated with Capital Expenses,
Plant Operations and Maintenance, and Administrative and General.
Specifically, we calculated Transportation by summing costs from
Worksheet A, column 3, lines 1 through 12 and subtracting line 5.03
(A&G Nonreimbursable costs).
5. Professional Liability Insurance: Professional Liability
Insurance reflects premiums, paid losses, and self-insurance costs.
Specifically we calculated Professional Liability Insurance by summing
costs from Worksheet S2, lines 27.01, 27.02 and 27.03.
6. Fixed Capital: Fixed Capital-related costs reflect the portion
of Medicare-allowable costs reported in ``Capital Related Buildings and
Fixtures'' (Worksheet A, column 5, line 1). We calculated this Medicare
allowable portion by first calculating a ratio for each provider that
reflects fixed capital costs as a percentage of HHA reimbursable
services. Specifically this ratio was calculated as the sum of costs
from Worksheet B, column 1, lines 6 through 12 divided by the sum of
costs from Worksheet B, column 1, line 1 minus lines 3 through 5. This
percentage is then applied to the sum of the costs from Worksheet A,
column 5, line 1.
7. Movable Capital: Movable Capital-related costs reflect the
portion of Medicare-allowable costs reported in ``Capital Related
Moveable Equipment'' (Worksheet A, column 5, line 2). We calculated
this Medicare allowable portion by first calculating a ratio for each
provider that reflects movable capital costs as a percentage of HHA
reimbursable services. Specifically this ratio was calculated as the
sum of costs from Worksheet B, column 2, lines 6 through 12 divided by
the sum of costs from Worksheet B, column 2, line 2 minus lines 3
through 5. This percentage is then applied to the sum of the costs from
Worksheet A, column 5, line 2.
8. All Other (residual): The ``All Other'' cost weight is a
residual and was calculated by subtracting the major cost weight
percentages (Wages and Salaries, Benefits, Direct Patient Care Contract
Labor, Transportation, Professional Liability Insurance, Fixed Capital,
and Movable Capital) from 1.
As prescription drugs and DME are not payable under the HH PPS, we
maintained our policy to exclude those items from the home health
market basket. Totals within each of the major cost categories were
edited to remove reports where the data were deemed unreasonable (for
example, when total costs were not greater than zero). We then
determined the proportion of total Medicare allowable costs that each
category represents. For all of the major cost categories except the
``residual'' All Other cost weight, we then removed those providers
whose derived cost weights fall in the top and bottom 5 percent of
provider-specific cost weights to ensure the removal of outliers. After
the outliers were removed, we summed the costs for each category across
all remaining providers. Then, we divided this by the sum of total
Medicare allowable costs across all remaining
[[Page 56427]]
providers to obtain a cost weight for the 2016-based home health market
basket for the given category.
Table 7 shows the major cost categories and their respective cost
weights as derived from the Medicare cost reports for this final rule
with comment period.
[GRAPHIC] [TIFF OMITTED] TR13NO18.012
The decrease in the wages and salaries cost weight of 1.2
percentage points and the decrease in the benefits cost weight of 1.3
percentage points is attributable to both employed compensation and
direct patient care contract labor costs as reported on the MCR data.
Our analysis of the MCR data shows that the decrease in the
compensation cost weight of 2.4 percentage points (calculated by
combining wages and salaries and benefits) from 2010 to 2016 occurred
among for-profit, nonprofit, and government providers and among
providers serving only rural beneficiaries, only urban beneficiaries,
or both rural and urban beneficiaries.
Over the 2010 to 2016 time period, the average number of FTEs per
provider decreased considerably. This corresponds with the HHA claims
analysis published on page 35279 of the CY 2018 proposed rule (https://www.gpo.gov/fdsys/pkg/FR-2017-07-28/pdf/2017-15825.pdf), which shows
that the number of visits per 60-day episode has decreased from 19.8
visits in 2010 to 17.9 visits in 2016 for Medicare PPS. Medicare visits
account for approximately 60 percent of total visits.
The direct patient care contract labor costs are contract labor
costs for skilled nursing, physical therapy, occupational therapy,
speech therapy, and home health aide cost centers. We allocated these
direct patient care contract labor costs to the Wages and Salaries and
Benefits cost categories based on each provider's relative proportions
of both employee wages and salaries and employee benefits costs. For
example, the direct patient care contract labor costs that are
allocated to wages and salaries is equal to: (1) The employee wages and
salaries costs as a percent of the sum of employee wages and salaries
costs and employee benefits costs times; and (2) direct patient care
contract labor costs. Nondirect patient care contract labor costs (such
as contract labor costs reported in the Administrative and General cost
center of the MCR) are captured in the ``All Other'' residual cost
weight and later disaggregated into more detail as described later in
this section. This is a similar methodology that was implemented for
the 2010-based home health market basket.
We further divided the ``All Other'' residual cost weight estimated
from the 2016 Medicare cost report data into more detailed cost
categories. To divide this cost weight we used the 2007 Benchmark I-O
``Use Tables/Before Redefinitions/Purchaser Value'' for NAICS 621600,
Home Health Agencies, published by the BEA. These data are publicly
available at http://www.bea.gov/industry/io_annual.htm. The BEA
Benchmark I-O data are generally scheduled for publication every 5
years. The most recent data available at the time of rebasing was for
2007. The 2007 Benchmark I-O data are derived from the 2007 Economic
Census and are the building blocks for BEA's economic accounts.
Therefore, they represent the most comprehensive and complete set of
data on the economic processes or mechanisms by which output is
produced and distributed.\8\ Besides Benchmark I-O estimates, BEA also
produces Annual I-O estimates. While based on a similar methodology,
the Annual I-O estimates reflect less comprehensive and less detailed
data sources and are subject to revision when benchmark data become
available. Instead of using the less detailed Annual I-O data, we
inflated the detailed 2007 Benchmark I-O data forward to 2016 by
applying the annual price changes from the respective price proxies to
the appropriate market basket cost categories that are obtained from
the 2007 Benchmark I-O data. We repeated this practice for each year.
Then, we calculated the cost shares that each cost category represents
of the 2007 data inflated to 2016. These resulting 2016 cost shares
were applied to the ``All Other'' residual cost weight to obtain the
detailed cost weights for the 2016-based home health market basket. For
example, the cost for Operations and Maintenance represents 8.0 percent
of the sum of the ``All Other'' 2007 Benchmark I-O HHA Expenditures
inflated to 2016. Therefore, the Operations and Maintenance cost weight
represents 8.0 percent of the 2016-based home health market basket's
``All Other'' cost category (19.0 percent), yielding an Operations and
Maintenance cost weight of 1.5 percent in the 2016-based home health
market basket (0.080 x 19.0 percent = 1.5 percent). For the 2010-based
home health market basket, we used the same methodology utilizing the
2002 Benchmark I-O data (aged to 2010).
---------------------------------------------------------------------------
\8\ http://www.bea.gov/papers/pdf/IOmanual_092906.pdf.
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Using this methodology, we derived nine detailed cost categories
from the 2016-based home health market basket ``All Other'' residual
cost weight (19.0 percent). These categories are: (1) Operations and
Maintenance; (2) Administrative Support; (3) Financial Services; (4)
Medical Supplies; (5) Rubber and Plastics; (6) Telephone; (7)
Professional Fees; (8) Other Products; and (9) Other Services. The
2010-based home health market basket included a
[[Page 56428]]
separate cost category for Postage; however, due to its small weight
for the 2016-based home health market basket, we proposed to eliminate
the stand-alone cost category for Postage and include these expenses in
the Other Services cost category.
Table 8 lists the final 2016-based home health market basket cost
categories, cost weights, and price proxies.
[GRAPHIC] [TIFF OMITTED] TR13NO18.013
We received no comments on the derivation of the 2016-based Home
Health market basket cost categories and weights and therefore are
finalizing the categories and weights without modification.
d. 2016-Based Home Health Market Basket Price Proxies
After we computed the CY 2016 cost category weights for the rebased
home health market basket, we selected the most appropriate wage and
price indexes to proxy the rate of change for each expenditure
category. With the exception of the price index for Professional
Liability Insurance costs, the price proxies are based on Bureau of
Labor Statistics (BLS) data and are grouped into one of the following
BLS categories:
Employment Cost Indexes: Employment Cost Indexes (ECIs)
measure the rate of change in employee wage rates and employer costs
for employee benefits per hour worked. These indexes are fixed-weight
indexes and strictly measure the change in wage rates and employee
benefits per hour. They are not affected by shifts in skill mix. ECIs
are superior to average hourly earnings as price proxies for input
price indexes for two reasons: (a) They measure pure price change; and
(b) they are available by occupational groups, not just by industry.
Consumer Price Indexes: Consumer Price Indexes (CPIs)
measure change in the prices of final goods and services bought by the
typical consumer. Consumer price indexes are used when the expenditure
is more similar to that of a purchase at the retail level rather than
at the wholesale level, or if no appropriate Producer Price Indexes
(PPIs) were available.
Producer Price Indexes: PPIs measures average changes in
prices received by domestic producers for their goods and services.
PPIs are used to measure price changes for goods sold in other than
retail markets. For example, a PPI for movable equipment is used rather
than a CPI for equipment. PPIs in some cases are preferable price
proxies for goods that HHAs purchase at wholesale levels. These fixed-
weight indexes are a measure of price change at the producer or at the
intermediate stage of production.
We evaluated the price proxies using the criteria of reliability,
timeliness, availability, and relevance. Reliability indicates that the
index is based on valid statistical methods and has low sampling
variability. Widely accepted statistical methods ensure that the data
were collected and aggregated in way that can be replicated. Low
sampling variability is desirable because it indicates that sample
reflects the typical members of the population. (Sampling variability
is variation that occurs by chance because a sample was surveyed rather
than the entire population.) Timeliness implies that the proxy is
published regularly, preferably at least once a quarter. The market
baskets are
[[Page 56429]]
updated quarterly and therefore it is important the underlying price
proxies be up-to-date, reflecting the most recent data available. We
believe that using proxies that are published regularly helps ensure
that we are using the most recent data available to update the market
basket. We strive to use publications that are disseminated frequently
because we believe that this is an optimal way to stay abreast of the
most current data available. Availability means that the proxy is
publicly available. We prefer that our proxies are publicly available
because this would help ensure that our market basket updates are as
transparent to the public as possible. In addition, this enables the
public to be able to obtain the price proxy data on a regular basis.
Finally, relevance means that the proxy is applicable and
representative of the cost category weight to which it is applied. The
CPIs, PPIs, and ECIs selected for use in the HH market basket meet
these criteria. Therefore, we believe that they continue to be the best
measure of price changes for the cost categories to which they would be
applied.
As part of the revising and rebasing of the home health market
basket, we proposed to rebase the home health blended Wages and
Salaries index and the home health blended Benefits index. We proposed
to use these blended indexes as price proxies for the Wages and
Salaries and the Benefits portions of the proposed 2016-based home
health market basket, as we did in the 2010-based home health market
basket. A more detailed discussion is provided in this rule.
Wages and Salaries: For measuring price growth in the
2016-based home health market basket, we proposed to apply six price
proxies to six occupational subcategories within the Wages and Salaries
component, which would reflect the HHA occupational mix. This is the
same approach used for the 2010-based index. We used a blended wage
proxy because there is not a published wage proxy specific to the home
health industry.
We proposed to continue to use the National Industry-Specific
Occupational Employment and Wage estimates for North American
Industrial Classification System (NAICS) 621600, Home Health Care
Services, published by the BLS Office of Occupational Employment
Statistics (OES) as the data source for the cost shares of the home
health blended wage and benefits proxy. This is the same data source
that was used for the 2010-based HHA blended wage and benefit proxies;
however, we proposed to use the May 2016 estimates in place of the May
2010 estimates. Detailed information on the methodology for the
national industry-specific occupational employment and wage estimates
survey can be found at http://www.bls.gov/oes/current/oes_tec.htm.
The needed data on HHA expenditures for the six occupational
subcategories (Health-Related Professional and Technical, Non Health-
Related Professional and Technical, Management, Administrative, Health
and Social Assistance Service, and Other Service Workers) for the wages
and salaries component were tabulated from the May 2016 OES data for
NAICS 621600, Home Health Care Services. Table 9 compares the 2016
occupational assignments to the 2010 occupational assignments of the
six CMS designated subcategories. If an OES occupational classification
does not exist in the 2010 or 2016 data we use ``n/a.''
BILLING CODE 4120-01-P
[[Page 56430]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.014
[[Page 56431]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.015
Total expenditures by occupation were calculated by taking the OES
number of employees multiplied by the OES annual average salary for
each subcategory, and then calculating the proportion of total wage
costs that each
[[Page 56432]]
subcategory represents. The proportions listed in Table 10 represent
the Wages and Salaries blend weights.
[GRAPHIC] [TIFF OMITTED] TR13NO18.016
A comparison of the yearly changes from CY 2016 to CY 2019 for the
2010-based home health Wages and Salaries blend and the 2016-based home
health Wages and Salaries blend is shown in Table 11. The annual
increases in the two price proxies are the same when rounded to one
decimal place.
[GRAPHIC] [TIFF OMITTED] TR13NO18.017
Benefits: For measuring Benefits price growth in the 2016-
based home health market basket, we proposed to apply applicable price
proxies to the six occupational subcategories that are used for the
Wages and Salaries blend. The six categories in Table 12 are the same
as those in the 2010-based home health market basket and include the
same occupational mix as listed in Table 12.
[[Page 56433]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.018
There is no available data source that exists for benefit
expenditures by occupation for the home health industry. Thus, to
construct weights for the home health benefits blend we calculated the
ratio of benefits to wages and salaries for CY 2016 for the six ECI
series we used in the blended `wages and salaries' and `benefits'
indexes. To derive the relevant benefits weight, we applied the
benefit-to-wage ratios to each of the six occupational subcategories
from the 2016 OES wage and salary weights, and normalized. For example,
the ratio of benefits to wages from the 2016 home health wages and
salaries blend and the benefits blend for the management category is
0.984. We applied this ratio to the 2016 OES weight for wages and
salaries for management, 7.6 percent, and then normalized those weights
relative to the other 5 benefit occupational categories to obtain a
benefit weight for management of 7.3 percent.
A comparison of the yearly changes from CY 2016 to CY 2019 for the
2010-based home health Benefits blend and the 2016-based home health
Benefits blend is shown in Table 13. The annual increases in the two
price proxies are the same when rounded to one decimal place.
[GRAPHIC] [TIFF OMITTED] TR13NO18.019
Operations and Maintenance: We proposed to use CPI U.S.
city average for Fuel and utilities (BLS series code #CUUR0000SAH2) to
measure price growth of this cost category. The same proxy was used for
the 2010-based home health market basket.
Professional Liability Insurance: We proposed to use the
CMS Physician Professional Liability Insurance price index to measure
price growth of this cost category. The same proxy was used for the
2010-based home health market basket.
To accurately reflect the price changes associated with physician
PLI, each year we collect PLI premium data for physicians from a
representative sample of commercial carriers and publically available
rate filings as maintained by each State's Association of Insurance
Commissioners. As we require for our other price proxies, the PLI price
proxy is intended to reflect the pure price change associated with this
particular cost category. Thus, the level of liability coverage is held
constant from year to year. To accomplish this, we obtain premium
information from a sample of commercial carriers for a fixed level of
coverage, currently $1 million per occurrence and a $3 million annual
limit. This information is collected for every State by physician
specialty and risk class. Finally, the State-level, physician-specialty
data are aggregated to compute a national total, using counts of
physicians by State and specialty as provided in the American Medical
Association (AMA) publication, Physician Characteristics and
Distribution in the U.S.
Administrative and Support: We proposed to use the ECI for
Total compensation for Private industry workers in Office and
administrative support (BLS series code #CIU2010000220000I) to measure
price growth of this cost category. The same proxy was used for the
2010-based home health market basket.
Financial Services: We proposed to use the ECI for Total
compensation for Private industry workers in Financial activities (BLS
series code #CIU201520A000000I) to measure price growth of this cost
category. The same proxy was used for the 2010-based home health market
basket.
Medical Supplies: We proposed to use the PPI Commodity
data for Miscellaneous products-Medical, surgical & personal aid
devices (BLS series code #WPU156) to measure price growth of this cost
category. The same
[[Page 56434]]
proxy was used for the 2010-based home health market basket.
Rubber and Plastics: We proposed to use the PPI Commodity
data for Rubber and plastic products (BLS series code #WPU07) to
measure price growth of this cost category. The same proxy was used for
the 2010-based home health market basket.
Telephone: We proposed to use CPI U.S. city average for
Telephone services (BLS series code #CUUR0000SEED) to measure price
growth of this cost category. The same proxy was used for the 2010-
based home health market basket.
Professional Fees: We proposed to use the ECI for Total
compensation for Private industry workers in Professional and related
(BLS series code #CIS2010000120000I) to measure price growth of this
category. The same proxy was used for the 2010-based home health market
basket.
Other Products: We proposed to use the PPI Commodity data
for Final demand-Finished goods less foods and energy (BLS series code
#WPUFD4131) to measure price growth of this category. The same proxy
was used for the 2010-based home health market basket.
Other Services: We proposed to use the ECI for Total
compensation for Private industry workers in Service occupations (BLS
series code #CIU2010000300000I) to measure price growth of this
category. The same proxy was used for the 2010-based home health market
basket.
Transportation: We proposed to use the CPI U.S. city
average for Transportation (BLS series code #CUUR0000SAT) to measure
price growth of this category. The same proxy was used for the 2010-
based home health market basket.
Fixed capital: We proposed to use the CPI U.S. city
average for Owners' equivalent rent of residences (BLS series code
#CUUS0000SEHC) to measure price growth of this cost category. The same
proxy was used for the 2010-based home health market basket.
Movable Capital: We proposed to use the PPI Commodity data
for Machinery and equipment (BLS series code #WPU11) to measure price
growth of this cost category. The same proxy was used for the 2010-
based home health market basket.
Comment: Several commenters stated they do not believe the CY 2019
home health market basket adequately reflects compensation pressures
faced by home health providers. A commenter recommended that CMS build
into the 2019 market basket update an increase to reflect general
health care wage increases.
Response: We believe the CY 2019 market basket update of 3.0
percent reflects the expected compensation price increases that home
health agencies will face in CY 2019. The compensation component of the
2016-based Home Health market basket is 76.1 percent. The weight for
the ``Wages and Salaries'' cost category is 65.1 percent and the weight
for the ``Benefits'' cost category is 10.9 percent. Each of these two
respective cost categories are proxied by price indices that reflect
the occupational mix of home health staff for the following categories:
Health-related professional and technical; non health-related
professional and technical; management; administrative; health and
social assistance services; and other service occupations. Full details
on these price indices can be found in the CY 2019 HH PPS proposed rule
(83 FR 32364 through 32366). For CY 2019, the estimated ``Wages and
Salaries'' inflation is 3.2 percent and the estimated ``Benefits''
inflation is 3.0 percent. We believe the CY 2019 market basket update
adequately reflects these projected price increases associated with
wage increases specific to the health and non-health occupations used
by the home health industry.
e. Rebasing Results
After consideration of public comments, we are finalizing the
proposed 2016-based home health market basket without modification. A
comparison of the yearly changes from CY 2014 to CY 2021 for the 2010-
based home health market basket and the final 2016-based home health
market basket is shown in Table 14.
[GRAPHIC] [TIFF OMITTED] TR13NO18.020
Table 14 shows that the forecasted rate of growth for CY 2019 for
the 2016-based home health market basket is 3.0 percent, the same rate
of growth as estimated using the 2010-based home health market basket;
other forecasted years also show a similar increase. Similarly, the
historical estimates of the growth in the 2016-based and 2010-based
home health market basket are the same except for CY 2015 where the
[[Page 56435]]
2010-based home health market basket is 0.1 percentage point higher.
The growth rates in Table 14 are based upon IHS Global Inc.'s (IGI)
3rd quarter 2018 forecast. IGI is a nationally recognized economic and
financial forecasting firm that contracts with CMS to forecast the
components of the market baskets. We noted in the proposed rule that if
more recent data were subsequently available (for example, a more
recent estimate of the market basket), we would use such data to
determine the market basket increases in the final rule. In that
proposed rule the forecasted rate of growth for CY 2019, based on IGI's
1st quarter 2018 forecast, for the 2016-based home health market basket
was 2.8 percent (83 FR 32368).
Comment: A commenter asked if the 2002 through 2018 increases in
the market basket represent the percentage increases in consumer health
care costs (defined by the commenter as insurance premiums and cost for
services) during the same time period. The commenter further stated the
inflationary rates used understated what the actual change to costs
would have been during this period.
Response: We believe the commenter may be confusing the concept of
the CMS market basket, which is an input price index, with the concept
of a consumer price index, which is an output price index. An input
price index measures the change in the prices of goods and services
bought by producers or providers as intermediate inputs. An output
price index measures the change in the prices of goods and services
sold as output by producers.
The 2016-based HHA market basket, along with its predecessors such
as the 2010-based HHA market basket, are fixed-weight indices that are
intended to measure the input prices used in providing home health care
services. The market basket by definition is a price index rather than
a cost index and, therefore, only accounts for changes in prices,
holding quantities constant. In order to reflect the changes in the mix
of input costs over time, CMS rebases the market basket periodically to
ensure that the index is reflecting the most up to date relative cost
shares for specific categories of expenses. We have found that the
relative cost shares for each category do not change substantially from
year to year.
The current CY 2019 market basket update factor of 3.0 percent
reflects the projected price growth in the input costs to provide home
health services. This forecast is based on the IHS Global Inc. (IGI)
third quarter 2018 forecast. IGI is a nationally recognized economic
and financial forecasting firm that contracts with CMS to forecast the
components of the market baskets.
We also note that according to the Medicare Payment Advisory
Committee, Medicare home health revenue has greatly exceeded Medicare
home health costs since PPS implementation, with the most recent
Medicare margins for 2016 estimated to be 15.5 percent (http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch9_sec_rev_0518.pdf)
f. Labor-Related Share
Effective for CY 2019, we revised the labor-related share to
reflect the 2016-based home health market basket Compensation (Wages
and Salaries plus Benefits) cost weight. The current labor-related
share is based on the Compensation cost weight of the 2010-based home
health market basket. Based on the 2016-based home health market
basket, the labor-related share would be 76.1 percent and the non-
labor-related share would be 23.9 percent. The labor-related share for
the 2010-based home health market basket was 78.535 percent and the
non-labor-related share was 21.465 percent. As explained earlier, the
decrease in the compensation cost weight of 2.4 percentage points is
attributable to both employed compensation (wages and salaries and
benefits for employees) and direct patient care contract labor costs as
reported in the MCR data. Table 15 details the components of the labor-
related share for the 2010-based and 2016-based home health market
baskets.
[GRAPHIC] [TIFF OMITTED] TR13NO18.021
There are no changes to the labor-related share in this final rule
with comment period compared to the labor related share in the proposed
rule (83 FR 32368).
We implemented the revision to the labor-related share of 76.1
percent in a budget neutral manner. This proposal would be consistent
with our policy of implementing the annual recalibration of the case-
mix weights and update of the home health wage index in a budget
neutral manner.
Comment: Several commenters disagreed with CMS' proposal to reduce
the labor related share, because such a change could result in less
care for patients.
Response: The labor related share is composed of the Wages &
Salaries and Benefits cost weights from the 2016-based home health
market basket. These cost weights were calculated using the 2016
Medicare cost report data (form CMS-1728-94), which is provided
directly by freestanding home health agencies. The 2016 data was the
most comprehensive data source available for determining the CY 2019
labor-related share at the time of rulemaking. The CY 2018 labor-
related share of 78.535 percent was based on the 2010-based home health
market basket Wages and Salaries and Benefit cost weights, which were
calculated using the 2010 Medicare cost report data. Therefore, we
believe the labor-related share of 76.1 percent is technically
appropriate as it is based on more recent Medicare cost report data
reported by home health agencies.
Comment: Another commenter agreed with CMS' proposal to reduce the
labor related share.
[[Page 56436]]
Response: We appreciate the commenter's support and agree that the
labor-related share should be reduced from 78.535 percent to 76.1
percent as it reflects the most recent Medicare cost report data for
home health agencies available at the time of rebasing.
Final Decision: After consideration of public comments, based on
the 2016-based home health market basket, we are finalizing the
proposed labor related share of 76.1 percent and the non-labor-related
share of 23.9 percent.
g. Multifactor Productivity
In the CY 2015 HHA PPS final rule (79 FR 38384 through 38384), we
finalized our methodology for calculating and applying the MFP
adjustment. As we explained in that rule, section 1895(b)(3)(B)(vi) 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)), 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.
Based on IHS Global Inc.'s (IGI's) 3rd quarter 2018 forecast with
history through the 2nd quarter of 2018, the projected MFP adjustment
(the 10-year moving average of MFP for the period ending December 31,
2019) for CY 2019 is 0.8 percent.
We noted in the proposed rule that if more recent data were
subsequently available (for example, a more recent estimate of the MFP
adjustment), we would use such data to determine the MFP adjustment in
the final rule. For comparison purposes, the proposed MFP adjustment
for CY 2019 was 0.7 percent (83 FR 32368), and was based on IGI's 1st
quarter 2018 forecast.
2. CY 2019 Market Basket Update for HHAs
Using IGI's third quarter 2018 forecast, the MFP adjustment for CY
2019 is projected to be 0.8 percent. In accordance with section
1895(b)(3)(B)(iii) of the Act, we proposed to base the CY 2019 market
basket update, which is used to determine the applicable percentage
increase for HHA payments, on the most recent estimate of the 2016-
based home health market basket. Based on IGI's third quarter 2018
forecast with history through the second quarter of 2018, the projected
increase of the 2016-based home health market basket for CY 2019 is 3.0
percent. We then reduce this percentage increase by the current
estimate of the MFP adjustment for CY 2019 of 0.8 percentage point in
accordance with 1895(b)(3)(B)(vi) of the Act. Therefore, the current
estimate of the CY 2019 HHA payment update is 2.2 percent (3.0 percent
market basket update, less 0.8 percentage point MFP adjustment).
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 2019, the home health payment
update would be 0.2 percent (2.2 percent minus 2 percentage points).
Comment: Several commenters agreed with CMS' proposed 2.1 percent
payment increase.
Response: We appreciate the commenters' support. The proposed 2.1
percent payment increase was based on IGI Global Inc.'s first quarter
2018 forecast of the 2016-based HHA market basket and the 10-year
moving average of annual economy-wide private nonfarm business. As
noted in the proposed rule, if a more recent forecast of the market
basket and MFP was available, we would use such data to determine the
CY 2019 market basket update and MFP adjustment in the final rule.
Based on IHS Global Inc.'s (IGI) third quarter 2018 forecast, we
determine a payment increase of 2.2 percent for the final update
percentage as previously stated.
Based on IGI's third quarter 2018 forecast, we are finalizing the
CY 2019 HHA payment update at 2.2 percent (3.0 percent market basket
update, less 0.8 percentage point MFP adjustment).
3. CY 2019 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 2019, 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 continue to use
the pre-floor, pre-reclassified hospital wage index as the wage
adjustment to the labor portion of the HH PPS rates. For CY 2019, the
updated wage data are for hospital cost reporting periods beginning on
or after October 1, 2014, and before October 1, 2015 (FY 2015 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 2019 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
2019, the only urban area without inpatient hospital wage data is
Hinesville, GA (CBSA 25980).
[[Page 56437]]
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.\9\ The most recent OMB Bulletin (No. 18-
03) was published on April 10, 2018 and is available at: https://www.whitehouse.gov/wp-content/uploads/2018/04/OMB-BULLETIN-NO.-18-03-Final.pdf. The revisions contained in OMB Bulletin No. 18-03 have no
impact on the geographic area delineations that are used to wage adjust
HH PPS payments.
---------------------------------------------------------------------------
\9\ https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
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The following is a summary of the comments received on the proposed
CY 2019 home health wage index and our responses:
Comment: Several commenters shared concerns in how the wage index
is calculated and implemented for home health agencies compared to
other prospective payment systems within the same CBSAs. A commenter
commented that hospitals are given the opportunity to appeal their
annual wage index and apply for geographic reclassification while HHAs
in the same geographic location are not given that same privilege. The
commenter believes that this lack of parity between different health
care sectors further exemplifies the inadequacy of CMS 'decision to
continue to use the pre-floor, pre-reclassified hospital wage index to
adjust home health services payment rates. They gave an example of
Massachusetts where every hospital in the Worchester CBSA and two
hospitals in the Providence-Bristol CBSA have been re-classified to the
Boston CBSA, effectively increasing their wage index by approximately 9
percent and 20 percent respectively. They further suggest that CMS use
wage index from Critical Access Hospitals in calculating the wage index
for HHAs to make the wage index more reflective of actual local wage
practices.
Response: We thank the commenters for their comments. We continue
to believe that the regulations and statutes that govern the HH PPS do
not provide a mechanism for allowing HHAs to seek geographic
reclassification or to utilize the rural floor provision that exists
for Hospital Inpatient Prospective Payment System (IPPS) hospitals.
Section 4410(a) of the Balanced Budget Act of 1997 provides that the
area wage index applicable to any hospital that is located in an urban
area of a State may not be less than the area wage index applicable to
hospitals located in rural areas in that State. This is the rural floor
provision and it is specific to hospitals. The reclassification
provision at section 1886(d)(10)(C)(i) of the Act states that the
Medicare Geographic Classification Review Board shall consider the
application of any subsection (d) hospital requesting the Secretary
change the hospital's geographic classification for purposes of payment
under the IPPS. This reclassification provision is only applicable to
hospitals as defined in section 1886(d) of the Act. In addition, we do
not believe that using hospital reclassification data would be
appropriate as these data are specific to the requesting hospitals. We
continue to believe that using the pre-floor, pre-reclassified hospital
wage index as the wage adjustment to the labor portion of the HH PPS
rates is appropriate and reasonable. Although the pre-floor, pre-
classified hospital wage index does not include data from Critical
Access Hospitals (CAHs), we believe that it reflects the relative level
of wages and wage-related costs applicable to providing HH services. As
we stated in the August 1, 2003 IPPS final rule (68 FR 45397), CAHs
represent a substantial number of hospitals with significantly
different labor costs in many labor market areas where they exist.
Comment: A commenter expressed concerns with CMS using CY 2015 wage
index figures for the CY 2019 wage index since there have been shifts
in the labor market in New York State.
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 wage index values are based on data submitted on the inpatient
hospital cost reports. We utilize efficient means to ensure and review
the accuracy of the hospital cost report data and resulting wage index.
The home health wage index is derived from the pre-floor, pre-
reclassified hospital; wage index, which is calculated based on cost
report data submitted from hospitals paid under the IPPS. All IPPS
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. In addition, 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. We believe that our review processes
result in an accurate reflection of the applicable wages for each labor
market area. The processes and procedures describing how the inpatient
hospital wage index is developed are discussed in the IPPS rule each
year, with the most recent discussion provided in the FY 2019 IPPS
final rule (83 FR 41362 through 41374 and 83 FR 41380 through 41383).
Any provider type may submit comments on the hospital wage index during
the annual IPPS rulemaking cycle.
Comment: A commenter believes that the CMS decision 10 years ago to
switch from Metropolitan Statistical Areas (MSAs) to CBSAs for the wage
adjustment to the rates has had negative financial ramifications for
HHAs in New York City. The commenter stated that unlike past MSA
designations, where all of the counties in the New York City
designation were from New York State, the 2006 CBSA wage index
designation added Bergen, Hudson, and Passaic counties from New Jersey
into the New York City CBSA. The commenter also noted that with the CY
2015 final rule, CMS added three more New Jersey counties (Middlesex,
Monmouth, and Ocean) to the CBSA used for New York City.
Response: The MSA delineations as well as the CBSA delineations are
determined by the Office of Management and Budget (OMB). The OMB
reviews its Metropolitan Area definitions preceding each decennial
census to reflect recent population changes. We believe that the OMB's
CBSA designations reflect the most recent available geographic
classifications and are a reasonable and appropriate way to define
geographic areas for purposes of wage index values. Over 10 years ago,
in our CY 2006 HH PPS final rule (70 FR 68132), we finalized the
adoption of the revised labor market area definitions as discussed in
the OMB Bulletin No. 03- 04 (June 6, 2003). In the December 27, 2000
Federal Register (65 FR 82228 through 82238), the OMB announced its new
standards for defining metropolitan and micropolitan statistical areas.
According to that notice, the OMB defines a CBSA, beginning in 2003, as
``a geographic entity associated with at least one core of 10,000 or
more population, plus adjacent territory that has a high degree of
social and economic integration with the core as
[[Page 56438]]
measured by commuting ties.'' The general concept of the CBSAs is that
of an area containing a recognized population nucleus and adjacent
communities that have a high degree of integration with that nucleus.
The purpose of the standards is to provide nationally consistent
definitions for collecting, tabulating, and publishing federal
statistics for a set of geographic areas. CBSAs include adjacent
counties that have a minimum of 25 percent commuting to the central
counties of the area. This is an increase over the minimum commuting
threshold for outlying counties applied in the previous MSA definition
of 15 percent. Based on the OMB's current delineations, as described in
the July 15, 2015 OMB Bulletin 15-01, the New Jersey counties of
Bergen, Hudson, Middlesex, Monmouth, Ocean, and Passaic belong in the
New York-Jersey City-White Plains, NY-NJ (CBSA 35614). In addition, for
the payment systems of other provider types, such as IPPS hospitals,
hospices, skilled nursing facilities (SNFs), inpatient rehabilitation
facilities (IRFs), and ESRD facilities, we have used CBSAs to define
their labor market areas for more than a decade.
Comment: A commenter questioned the validity of the wage index
data, especially in the case of the CBSA for Albany-Schenectady-Troy,
noting that in the past 5 years, this CBSA has seen its wage index
reduced 6.18 percent, going from 0.8647 in 2013 to a proposed CY 2019
wage index of 0.8179.
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.
Comment: A commenter recommended that providers meeting higher
minimum wage standards, such as HHAs, obtain additional supplemental
funding to better align payments with cost trends impacting providers.
Response: Regarding minimum wage standards, we note that such
increases will 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.
Final Decision: After considering the comments received in response
to the CY 2019 HH PPS proposed rule, we are finalizing our proposal to
continue to use the pre-floor, pre-reclassified hospital inpatient wage
index as the wage adjustment to the labor portion of the HH PPS rates.
For CY 2019, the updated wage data are for the hospital cost reporting
periods beginning on or after October 1, 2014 and before October 1,
2015 (FY 2015 cost report data). The final CY 2019 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 2019 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 is a national, standardized 60-day
episode payment rate. As set forth in Sec. 484.220, we adjust the
national, standardized 60-day episode payment rate 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. The labor-related share of the case-mix adjusted 60-day episode
is 76.1 percent and the non-labor-related share is 23.9 percent for CY
2019. The CY 2019 HH PPS rates use the same case-mix methodology as set
forth in the CY 2008 HH PPS final rule with comment period (72 FR
49762) and is adjusted as described in section III.B of this final rule
with comment period. The following are the steps we take to compute the
case-mix and wage-adjusted 60-day episode rate for CY 2019:
Multiply the national 60-day episode rate by the patient's
applicable case-mix weight.
Divide the case-mix adjusted amount into a labor (76.1
percent) and a non-labor portion (23.9 percent).
Multiply the labor portion by the applicable wage index
based on the site of service of the beneficiary.
Add the wage-adjusted portion to the non-labor portion,
yielding the case-mix and wage adjusted 60-day episode rate, subject to
any additional applicable adjustments.
In accordance with section 1895(b)(3)(B) of the Act, we proposed
the annual update of the HH PPS rates. Section 484.225 sets forth the
specific annual percentage update methodology. In accordance with Sec.
484.225(i), for a HHA that does not submit HH quality data, as
specified by the Secretary, the unadjusted national prospective 60-day
episode rate is equal to the rate for the previous calendar year
increased by the applicable HH market basket index amount 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 the national, standardized 60-day case-mix and wage-
adjusted episode payment on a split percentage payment approach. 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 (b)(2). We may base the initial percentage payment on
the submission of a request for anticipated payment (RAP) and the final
percentage payment on the submission of the claim for the episode, as
discussed in Sec. 409.43. The claim for the episode that the HHA
submits for the final percentage payment determines the total payment
amount for the episode and whether we make an applicable adjustment to
the 60-day case-mix and wage-adjusted episode payment. The end date of
the 60-day episode as reported on the claim determines which calendar
year rates Medicare will use to pay the claim.
We may also adjust the 60-day case-mix and wage-adjusted episode
payment based on the information submitted on the claim to reflect the
following:
A low-utilization payment adjustment (LUPA) is provided on
a per-visit basis as set forth in Sec. Sec. 484.205(c) and 484.230.
A partial episode payment (PEP) adjustment as set forth in
Sec. Sec. 484.205(d) and 484.235.
An outlier payment as set forth in Sec. Sec. 484.205(e)
and 484.240.
b. CY 2019 National, Standardized 60-Day Episode Payment Rate
Section 1895(b)(3)(A)(i) of the Act requires that the 60-day
episode base 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 2019 national, standardized
60-day episode payment rate, we apply a wage index
[[Page 56439]]
budget neutrality factor and a case- mix budget neutrality factor
described in section III.B of this final rule with comment period; and
the home health payment update percentage discussed in section III.C.2.
of this final rule with comment period.
To calculate the wage index budget neutrality factor, we simulated
total payments for non-LUPA episodes using the CY 2019 wage index
(including the application of the labor-related share of 76.1 percent
and the non-labor-related share of 23.9 percent) applied to CY 2017
utilization (claims) data and compared it to our simulation of total
payments for non-LUPA episodes using the CY 2018 wage index (including
the application of the current labor-related share of 78.535 percent
and the non-labor-related of 21.465) applied to CY 2017 utilization
(claims) data. By dividing the total payments for non-LUPA episodes
using the CY 2019 wage index by the total payments for non-LUPA
episodes using the CY 2018 wage index, we obtain a wage index budget
neutrality factor of 0.9985. We will apply the wage index budget
neutrality factor of 0.9985 to the calculation of the CY 2019 national,
standardized 60-day episode payment rate.
As discussed in section III.B. of this final rule with comment
period, to ensure the changes to the case-mix weights are implemented
in a budget neutral manner, we proposed to apply a case-mix weight
budget neutrality factor to the CY 2019 national, standardized 60-day
episode payment rate. The case-mix weight budget neutrality factor is
calculated as the ratio of total payments when CY 2019 case-mix weights
are applied to CY 2017 utilization (claims) data to total payments when
CY 2018 case-mix weights are applied to CY 2017 utilization data. The
case-mix budget neutrality factor for CY 2019 is 1.0169 as described in
section III.B. of this final rule with comment period. Next, we apply
the payment rates by the CY 2019 home health payment update percentage
of 2.2 percent as described in section III.C.2. of this final rule with
comment period. The CY 2019 national, standardized 60-day episode
payment rate is calculated in Table 16.
[GRAPHIC] [TIFF OMITTED] TR13NO18.022
The CY 2019 national, standardized 60-day episode payment rate for
an HHA that does not submit the required quality data is updated by the
CY 2019 home health payment update of 2.2 percent minus 2 percentage
points and is shown in Table 17.
[GRAPHIC] [TIFF OMITTED] TR13NO18.023
c. CY 2019 National Per-Visit Rates
The national per-visit rates are used to pay LUPAs (episodes with
four or fewer visits) 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 2019 national per-visit rates, we started with
the CY 2018 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 2019 wage
index and comparing it to simulated total payments for LUPA episodes
using the CY 2018 wage index. By dividing the total payments for LUPA
episodes using the CY 2019 wage index by the total payments for LUPA
episodes using the CY 2018 wage index, we obtained a wage index budget
neutrality factor of 0.9996. We apply the wage index budget neutrality
factor of 0.9996 in order to
[[Page 56440]]
calculate the CY 2019 national per-visit rates.
The LUPA per-visit rates are not calculated using case-mix weights.
Therefore, no case-mix weights budget neutrality factor is needed to
ensure budget neutrality for LUPA payments. Lastly, the per-visit rates
for each discipline are updated by the CY 2019 home health payment
update percentage of 2.2 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 2019 national per-visit rates for HHAs that submit the required
quality data are updated by the CY 2019 HH payment update percentage of
2.2 percent and are shown in Table 18.
[GRAPHIC] [TIFF OMITTED] TR13NO18.024
The CY 2019 per-visit payment rates for HHAs that do not submit the
required quality data are updated by the CY 2019 HH payment update
percentage of 2.2 percent minus 2 percentage points and are shown in
Table 19.
[GRAPHIC] [TIFF OMITTED] TR13NO18.025
d. Low-Utilization Payment Adjustment (LUPA) Add-On Factors
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. For
example, in the case of HHAs that do submit the required quality data,
for LUPA episodes that occur as the only episode or an initial episode
in a sequence of adjacent episodes, if the first skilled visit is SN,
the payment for that visit will be $270.27 (1.8451 multiplied by
$146.48), subject to area wage adjustment.
e. CY 2019 Non-Routine Medical Supply (NRS) Payment Rates
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, I.V. 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 2019 NRS conversion factor, we updated the CY 2018 NRS
conversion
[[Page 56441]]
factor ($53.03) by the CY 2019 home health payment update percentage of
2.2 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 2019 is shown in Table 20.
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Using the CY 2019 NRS conversion factor, the payment amounts for
the six severity levels are shown in Table 21.
[GRAPHIC] [TIFF OMITTED] TR13NO18.027
For HHAs that do not submit the required quality data, we updated
the CY 2018 NRS conversion factor ($53.03) by the CY 2019 home health
payment update percentage of 2.2 percent minus 2 percentage points. The
CY 2019 NRS conversion factor for HHAs that do not submit quality data
is shown in Table 22.
[GRAPHIC] [TIFF OMITTED] TR13NO18.028
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 23.
[[Page 56442]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.029
The following is a summary of the public comments received on the
CY 2019 Annual Payment Update and our responses.
Comment: Several commenters expressed concerns with the reduction
in the labor-related shares suggesting such a change will result in
less care for patients.
Response: We thank the commenters for expressing their concerns. As
noted in the proposed rule (83 FR 32368), the decrease in compensation
cost weight of 2.4 percentage points is attributable to both employed
compensation (wages and salaries and benefits for employees) and direct
patient care contract labor costs as reported in the MCR data. The
decreased labor-related share is implemented in a budget neutral
manner, which is consistent with the policies for implementing the
annual recalibration of the case-mix weights and update of the home
health wage index in a budget neutral manner.
Comment: A commenter stated that HHAs have received only one
positive inflation update since 2011 and that this has left them behind
in their ability to attract and retain medically trained personnel.
Response: The home health market basket growth rate measures input
price inflation associated with providing home health services. We
disagree with the commenter that home health agencies have only
received one positive inflation update since 2011 as the market basket
update has been approximately 2 percent or higher annually. The table
24 shows the home health market basket updates and productivity
adjustments from CY 2011 to CY 2018.
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Over the 2011 to 2018 time period, the home health market basket
update and home health payment rates have been reduced to reflect other
statutorily required adjustments (such as the MFP adjustment (required
by section 1895(b)(3)(B)(vi) of the Social Security Act), and rebasing
adjustments to the national, standardized 60-day episode payment rates
(required under section 3131(a) of the Patient Protection and
Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)). In
some years, this has resulted in the 60-day episode payment rates being
less than in prior years. The rationale and methodology regarding these
other adjustments, along with CMS response to comments, can be found in
prior CY HH PPS proposed and final rules.
We would note, however, that since PPS implementation and
particularly over the 2011 to 2016 time period, according to MedPAC,
freestanding home health agency margins have averaged roughly 14
percent. Furthermore, as shown in the 2016-based home health market
basket, approximately 76 percent of home health costs are compensation
costs; therefore, we disagree with the commenter's claims that they are
unable to attract and retain medically trained personnel due to
insufficient payment updates.
Comment: While several commenters commended and supported CMS on
recognizing the need for an increase in home health payments per 60-day
episode, MedPAC commented that this increase is not warranted based on
their analysis of payment adequacy.
Response: We note that we are statutorily required to update the
payment rates under the prospective payment system by the home health
payment update percentage in accordance with section 1895(b)(3)(B) of
the Act.
Final Decision: After considering all comments received on the
proposed payment rate update for CY 2019, we are finalizing the
application of the wage index budget neutrality factor (which includes
making the change in the labor-related share budget neutral), the case-
mix adjustment budget neutrality factor and the home health payment
update percentage in updating the home health payment rates for CY 2019
as proposed.
[[Page 56443]]
D. Rural Add-On Payments for CYs 2019 Through 2022
1. Background
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), 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 DRA 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 Bipartisan Budget Act of 2018 amended
section 421(a) of the MMA to extend the rural add-on by providing an
increase of 3 percent of the payment amount otherwise made under
section 1895 of the Act for HH services provided in a rural area (as
defined in section 1886(d)(2)(D) of the Act), for episodes and visits
ending before January 1, 2019.
2. Rural Add-On Payments for CYs 2019 Through 2022
Section 50208(a)(1)(D) of the BBA of 2018 adds a new subsection (b)
to section 421 of the MMA to provide rural add-on payments for episodes
and visits ending during CYs 2019 through 2022. It also mandates
implementation of a new methodology for applying those payments. Unlike
previous rural add-ons, which were applied to all rural areas
uniformly, the extension provides 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).
The proposed rule outlined how we categorized rural counties (or
equivalent areas) into the three distinct categories outlined in
section 50208 of the BBA of 2018 based on CY 2015 claims data and 2015
data from the Medicare Beneficiary Summary File, as well as 2010 Census
data. The rural add-on percentages and duration of rural add-on
payments outlined in law are shown in Table 25. The HH Pricer module,
located within CMS' claims processing system, will increase the base
payment rates provided in Tables 16 through 23 by the appropriate rural
add-on percentage prior to applying any case-mix and wage index
adjustments.
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The proposed rule further described the provisions of section
50208(a)(2) of the Bipartisan Budget Act of 2018, which amended section
1895(c) of the Act by adding a new requirement set out at section
1895(c)(3) of the Act. This requirement states that no claim for home
health services may be paid unless ``in the case of home health
services furnished on or after January 1, 2019, the claim contains the
code for the county (or equivalent area) in which the home health
service was furnished.'' This information will be necessary in order to
calculate the rural add-on payments. We proposed that HHAs enter the
FIPS state and county code, rather than the SSA state and county code,
on the claim.
The data used to categorize each county or equivalent area is
available in the Downloads section associated with the publication of
the proposed rule at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices-Items/CMS-1689-P.html. In addition, an Excel
file containing the rural county or equivalent area names, their FIPS
state and county codes, and their designation into one of the three
rural add-on categories is available for download.
The following is a summary of the public comments received on the
proposal for Rural Add-on Payments for CYs 2019 through 2022 and our
responses:
Comment: A commenter stated that they do not object to the
methodology used by CMS in implementing the rural add-on payments for
CYs 2019-CY 2022, but they request that CMS ask Congress to modify and
reauthorize the three percent rural safeguard for all rural counties to
ensure access to home health services by Medicare beneficiaries in
rural areas. Some commenters suggested that the cost reports indicate
FFS margins are at 5 percent or below, which they suggested reflects
the high cost of travel in rural areas and the cost of staffing of
visits into rural areas. The commenters indicated that many margins
included
[[Page 56444]]
the 3 percent rural add-on, thereby further justifying the continuation
of the rural-add on payments. Several commenters expressed concern with
the reduction and elimination of the rural add-on payments suggesting
that without the payments it would make caring for home health patients
in rural areas a challenge. Many urged CMS to continue providing rural
add-on payments after 2022 so that beneficiaries in rural communities
continue to have access to home health services. Several commenters
suggested that CMS establish a workgroup to examine rural costs and how
best to address those costs with an add-on payment.
Response: Section 421(a) of the MMA, as amended by section 50208 of
the BBA of 2018, provides a 3 percent rural add-on for HH services
provided in a rural area for episodes and visits ending before January
1, 2019. Section 421(b)(1) of the MMA, as amended by section 50208 of
the BBA of 2018, stipulates the percentage of rural add-on payments by
rural county (or equivalent area) classification for episodes and
visits ending during CYs 2019 through 2022, as provided in Table 25. As
these are statutory requirements, we do not have the authority to
provide a 3 percent rural add-on for episodes and visits ending on or
after January 1, 2019 across all rural areas, or to extend rural add-on
payments beyond the duration of the period for which rural add-on
payment are in place under section 421(b)(1) of the MMA. However, we
plan to continue to monitor the costs associated with providing home
health care in rural versus urban areas.
Comment: MedPAC stated that the rural payment add-on policy for
2019 is an improvement that better targets Medicare's scarce resources.
They further stated that average utilization is not significantly
different between urban and rural areas, but there is some variation
around this average, with high-and-low use areas found in counties.
They commented that the proposed policy targets payments to areas with
lower population density and limits payments to rural areas with higher
utilization.
Response: We thank MedPAC for their comments.
Comment: A commenter recommended that CMS research the impact the
rural add-on extension will have on low population density areas
particularly with the proposal to move to the cost per minute plus non-
routine supplies approach in estimating resource use under the PDGM.
Response: We thank the commenter for this suggestion. We will
continue monitoring the impacts due to policy changes, including the
changes in rural add-on payments for CYs 2019 through 2022, and 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 stated that a HHA may have demographic
changes within the four-year period and that they should be able to
retract and change their category of rural counties or equivalent areas
for the HH rural add-on payment.
Response: Section 421(b)(2)(a) of the MMA provides that the
Secretary shall make a determination only for a single time as to which
category under sections 421(b)(1)(A) (the ``High utilization''
category), 421(b)(1)(B) (the ``Low population density'' category), or
421(b)(1)(C) (the ``All other'' category) of the MMA that a rural
county or equivalent area is classified into, and that the
determination applies for the duration of the period for which rural
add-on payments are in place under section 421(b) of the MMA. As these
are statutory requirements, we do not have the authority to allow the
changes to rural county or equivalent area classifications suggested by
the commenters.
Final Decision: We are finalizing the policies for the provision of
rural add-on payments for CY 2019 through CY 2022 in accordance with
section 50208 of the BBA of 2018, which adds a new subsection to
section to 421 of the MMA. This includes finalizing the designations of
rural counties (or equivalent areas) into their respective categories
as outlined in the excel files published on the HHA center web page in
conjunction with the CY 2019 HH PPS proposed rule: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices-Items/CMS-1689-P.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending.
E. 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 beyond
the wage-adjusted threshold. The proportion of additional costs over
the outlier threshold amount paid as outlier payments is referred to as
the loss-sharing ratio.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through
70399), section 3131(b)(1) of the Affordable Care Act amended section
1895(b)(3)(C) of the Act, and required the Secretary to reduce the HH
PPS payment rates such that aggregate HH PPS payments were reduced by 5
percent. In addition, section 3131(b)(2) of the Affordable Care Act
amended section 1895(b)(5) of the Act by redesignating the existing
language as section 1895(b)(5)(A) of the Act, and revising the language
to state that the total amount of the additional payments or payment
adjustments for outlier episodes could not exceed 2.5 percent of the
estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of
the Affordable Care Act also added section 1895(b)(5)(B) of the Act
which capped outlier payments as a percent of total payments for each
HHA at 10 percent.
As such, beginning in CY 2011, we reduce payment rates by 5 percent
and target 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 target up to 2.5 percent of estimated
total payments to be paid as outlier
[[Page 56445]]
payments, and apply a 10 percent agency-level outlier cap.
In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through
43742 and 81 FR 76702), we described our concerns regarding patterns
observed in home health outlier episodes. Specifically, we noted that
the methodology for calculating home health outlier payments may have
created a financial incentive for providers to increase the number of
visits during an episode of care in order to surpass the outlier
threshold; and simultaneously created a disincentive for providers to
treat medically complex beneficiaries who require fewer but longer
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR
76702), we finalized changes to the methodology used to calculate
outlier payments, using a cost-per-unit approach rather than a cost-
per-visit approach. This change in methodology allows for more accurate
payment for outlier episodes, accounting for both the number of visits
during an episode of care and also the length of the visits provided.
Using this approach, we now convert the national per-visit rates into
per 15-minute unit rates. These per 15-minute unit rates are used to
calculate the estimated cost of an episode to determine whether the
claim will receive an outlier payment and the amount of payment for an
episode of care. In conjunction with our finalized policy to change to
a cost-per-unit approach to estimate episode costs and determine
whether an outlier episode should receive outlier payments, in the CY
2017 HH PPS final rule we also finalized the implementation of a cap on
the amount of time per day that would be counted toward the estimation
of an episode's costs for outlier calculation purposes (81 FR 76725).
Specifically, we limit the amount of time per day (summed across the
six disciplines of care) to 8 hours (32 units) per day when estimating
the cost of an episode for outlier calculation purposes.
We plan to publish the cost-per-unit amounts for CY 2019 in the
rate update change request, which is issued after the publication of
the CY 2019 HH PPS final rule. We note that in the CY 2017 HH PPS final
rule (81 FR 76724), we stated that we did not plan to re-estimate the
average minutes per visit by discipline every year. Additionally, we
noted that the per-unit rates used to estimate an episode's cost will
be updated by the home health update percentage each year, meaning we
would start with the national per- visit amounts for the same calendar
year when calculating the cost-per-unit used to determine the cost of
an episode of care (81 FR 76727). We note that we will continue to
monitor the visit length by discipline as more recent data become
available, and we may propose to update the rates as needed in the
future.
2. Fixed Dollar Loss (FDL) Ratio
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 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. Alternatively, a lower FDL ratio means that more episodes can
qualify for outlier payments, but outlier payments per episode 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
above the outlier threshold amount.
Simulations based on CY 2015 claims data (as of June 30, 2016)
completed for the CY 2017 HH PPS final rule showed that outlier
payments were estimated to represent approximately 2.84 percent of
total HH PPS payments in CY 2017, and as such, we raised the FDL ratio
from 0.45 to 0.55. We stated that raising the FDL ratio to 0.55, while
maintaining a loss-sharing ratio of 0.80, struck an effective balance
of compensating for high-cost episodes while still meeting the
statutory requirement to target up to, but no more than, 2.5 percent of
total payments as outlier payments (81 FR 76726). The national,
standardized 60-day episode payment amount is multiplied by the FDL
ratio. That amount is wage-adjusted to derive the wage-adjusted FDL
amount, which is added to the case-mix and wage-adjusted 60-day episode
payment amount to determine the outlier threshold amount that costs
have to exceed before Medicare would pay 80 percent of the additional
estimated costs.
In the CY 2019 proposed rule, we simulated payments using
preliminary CY 2017 claims data (as of March 2, 2018) and the CY 2018
HH PPS payment rates (82 FR 51676), and estimated that outlier payments
in CY 2018 would comprise 2.30 percent of total payments and
approximately 2.32 percent of total HH PPS payments in CY 2019. Our
simulations showed that the FDL ratio would need to be changed from
0.55 to 0.51 to pay up to, but no more than, 2.5 percent of total
payments as outlier payments in CY 2019.
Given the statutory requirement that total outlier payments not
exceed 2.5 percent of the total payments estimated to be made based
under the HH PPS, in the CY 2019 proposed rule, we proposed to lower
the FDL ratio for CY 2019 from 0.55 to 0.51 to better approximate the
2.5 percent statutory maximum. However, we noted that we were not
proposing a change to the loss-sharing ratio (0.80) for the HH PPS to
remain consistent with payment for high-cost outliers in other Medicare
payment systems (for example, IRF PPS, IPPS, etc.).
Using updated CY 2017 claims data (as of June 30, 2018) and the
final CY 2019 payment rates presented in section III.C of this final
rule with comment period, we estimate that outlier payments would
continue to constitute approximately 2.47 percent of total HH PPS
payments in CY 2019 under the current outlier methodology. Given the
statutory requirement to target up to, but no more than, 2.5 percent of
total payments as outlier payments, we believe that modifying the FDL
ratio from 0.55 to 0.51 with a loss-sharing ratio of 0.80 is
appropriate given the percentage of outlier payments projected for CY
2019.
3. Home Health Outlier Payments: Clinical Examples
In the CY 2019 HH PPS proposed rule, we also described clinical
examples of how care for a patient with ALS could qualify for an
additional outlier payment, which would serve to offset unusually high
costs associated with providing home health to a patient with unusual
variations in the amount of medically necessary care. (83 FR 32340).
The following is a summary of the comments received on outlier
payments under the HH PPS and our responses.
Comment: Several commenters recommended that CMS conduct a more
detailed analysis to determine whether the total cap of 2.5 percent of
total payments as outlier payments is adequate or whether it needs to
be increased for future years, particularly given the expected change
in Medicare beneficiary demographics anticipated in the coming years.
Response: As established in section 1895(b)(5) of the Act, both the
2.5 percent target of outlier payments to total home health payments
and the 10-percent cap on outlier payments at the home health agency
level are statutory
[[Page 56446]]
requirements. Therefore, we do not have the authority to adjust or
eliminate the 10-percent cap or increase the 2.5-percent target amount.
However, we will continue to evaluate for the appropriateness of those
elements of the outlier policy that may be modified, including the FDL
and the loss-sharing ratio. We note that other Medicare payment systems
with outlier payments, such as the IRF PPS and IPPS, annually reassess
the fixed-loss cost outlier threshold amount. Adjusting the outlier
threshold amount in order to target the statutorily required percentage
of total payments as outlier payments is standard practice.
Comment: A commenter recommended that CMS eliminate outlier
payments in their entirety.
Response: We believe that section 1895(b)(5)(A) of the Act allows
the Secretary the discretion as to whether or not to have an outlier
policy under the HH PPS. However, we also believe that outlier payments
are beneficial in that they help mitigate the incentive for HHAs to
avoid patients that may have episodes of care that result in unusual
variations in the type or amount of medically necessary care. The
outlier system is meant to help address extra costs associated with
extra, and potentially unpredictable, medically necessary care. We note
that we plan to continue evaluating whether or not an outlier policy
remains appropriate as well as ways to maintain an outlier policy for
episodes that incur unusually high costs due to patient care needs.
Comment: Several commenters suggested that we include the cost of
supplies in our outlier calculations as the inclusion of the cost of
supplies as opposed to the estimated costs would yield more accurate
payment totals to be used for determination of outlier payments.
Response: We appreciate the commenters' suggestion regarding the
inclusion of supplies in the outlier calculations. In order to
incorporate supply costs into the outlier calculation, significant
systems modifications would be required. However, we will consider
whether to add supply costs to the outlier calculations and evaluate
whether such a policy change is appropriate for future rulemaking.
Comment: A commenter expressed concerns about the per-unit outlier
approach established in 2017, stating that the assumptions regarding
this policy change were not accurate, thereby leading to difficulties
in the HHA community. The commenter further suggested that if the
outlier provision is to continue for CY2019, then we should revert to
the per-visit approach.
Response: We appreciate the commenter's feedback regarding the
revisions to the methodology utilized to calculate outliers in the HH
PPS. We maintain that the transition to the per-unit approach advanced
our objectives of better aligning payment with the costs of providing
care, but we will continue to monitor the impact of this policy change
as more recent data become available, and we may propose to modify the
outlier policy approaches as needed in the future.
Comment: Several commenters expressed support for the clinical
examples provided in the CY 2019 proposed rule and appreciated the
descriptions of how an outlier payment may be made for the provision of
care for patients living with significant longer-term and debilitating
conditions, including ALS.
Response: We appreciate the commenters' support and hope that the
examples illustrating how HHAs could be paid by Medicare for providing
care to patients with higher resource use in their homes served to
highlight that a patient's condition does not need to improve for home
health services to be covered by Medicare. We likewise hope that the
examples helped to provide a better understanding of Medicare coverage
policies and how outlier payments promote access to home health
services for such patients under the HH PPS.
Comment: A commenter requested that we identify specific diseases,
like ALS, that the commenter asserts are systematically underpaid and
exclude outlier payments for such patients from the fixed dollar loss
amount and cost sharing percentage up to the full reasonable cost of
care at those agencies accepting them for care. Additionally, the
commenter suggested that we separately identify those agencies in each
area who agree to accept high cost ALS patients under the
aforementioned exception. Moreover, the commenter suggested that we
undertake a demonstration to test whether an alternative payment
mechanism under the home health benefit similar to Disproportionate
Share Payments or a Special Needs Plans would provide full access to
home health care for ALS and similar patients as well as a
demonstration of a bridge program that is a combination of the
appropriate features of the Medicare home health and hospice benefits
that the commenter asserts would constitute a cost-effective
alternative to the use of both benefits and assure access to patients
needing ``Advanced Disease Management'' (ADM), blending curative
treatment approaches of home health and the palliative care benefits of
hospice in a manner that allows a seamless transition for persons whose
disease process is highly likely to advance and result in death within
a two-year period.
Response: We appreciate the commenter's feedback regarding the
suggested modifications to the home health outlier calculation as well
as the recommendation for possible demonstrations related to home
health cases that may qualify for an outlier payment. We maintain that
section 1895(b)(5)(A) of the Act allows the Secretary the discretion as
to whether or not to have an outlier policy under the HH PPS and we
believe that outlier payments are beneficial in that they help mitigate
the incentive for HHAs to avoid patients that may have episodes of care
that result in unusual variations in the type or amount of medically
necessary care. The outlier system is meant to help address extra costs
associated with extra, and potentially unpredictable, medically
necessary care. The outlier calculation is based upon total payments
within the HH PPS and we do not believe it would be appropriate to
exclude certain cases from the overall calculation or to make
additional payments to certain providers that offer services to home
health beneficiaries with a certain clinical profile. Regarding the
possibility of a demonstration for those beneficiaries with high
resource use, we will consider the comments as we develop new models
through the Center for Medicare and Medicaid Innovation. We note that
we would need to determine whether such a model would meet the
statutory requirements to be expected to reduce Medicare expenditures
and preserve or enhance the quality of care for beneficiaries.
Final Decision: We are finalizing the change to the FDL ratio or
loss sharing ratio for CY 2019. We are establishing an FDL ratio of
0.51 with a loss-sharing ratio of 0.80 for CY 2019. We will continue to
monitor outlier payments and continue to explore ways to maintain an
outlier policy for episodes that incur unusually high costs.
F. Implementation of the Patient-Driven Groupings Model (PDGM) for CY
2020
1. Summary of the Proposed PDGM Model, Data, and File Construction
To better align payment with patient care needs and better ensure
that clinically complex and ill beneficiaries have adequate access to
home health care, we proposed case-mix methodology refinements through
the
[[Page 56447]]
implementation of the Patient-Driven Groupings Model (PDGM). We
proposed to implement the PDGM for home health periods of care
beginning on or after January 1, 2020. 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.
Costs during an episode/period of care are estimated based on the
concept of resource use, which measures the costs associated with
visits performed during a home health episode/period. For the current
HH PPS case-mix weights, we use Wage Weighted Minutes of Care (WWMC),
which uses data from the Bureau of Labor Statistics (BLS) reflecting
the Home Health Care Service Industry. For the PDGM, we proposed
shifting to a Cost-Per-Minute plus Non-Routine Supplies (CPM + NRS)
approach, which uses information from the Medicare Cost Report. The CPM
+ NRS approach incorporates a wider variety of costs (such as
transportation) compared to the BLS estimates and the costs are
available for individual HHA providers while the BLS costs are
aggregated for the Home Health Care Service industry.
Similar to the current payment system, we proposed that 30-day
periods under the PDGM would be classified as ``early'' or ``late''
depending on when they occur within a sequence of 30-day periods. Under
the current HH PPS, the first two 60-day episodes of a sequence of
adjacent 60-day episodes are considered early, while the third 60-day
episode of that sequence and any subsequent episodes are considered
late. Under the PDGM, we proposed that the first 30-day period would be
classified as early and all subsequent 30-day periods in the sequence
(second or later) would be classified as late. We proposed to adopt
this episode timing classification for 30-day periods with the
implementation of the PDGM. Similar to the current payment system, we
proposed that a 30-day period could not be considered early unless
there was a gap of more than 60 days between the end of one period and
the start of another. The comprehensive assessment would 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.''
Under the PDGM, we proposed that each 30-day period would 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. The 30-day period would be categorized as
institutional if an acute or post-acute care stay occurred within the
prior 14 days to the start of the 30-day period of care. The 30-day
period would be categorized as community if there was no acute or post-
acute care stay in the 14 days prior to the start of the 30-day period
of care.
We proposed further grouping 30-day periods into one of six
clinical groups based on the principal diagnosis. The principal
diagnosis reported would provide information to describe the primary
reason for which patients were receiving home health services under the
Medicare home health benefit. The proposed six clinical groups, were as
follows:
Musculoskeletal Rehabilitation.
Neuro/Stroke Rehabilitation.
Wounds- Post-Op Wound Aftercare and Skin/Non-Surgical
Wound Care.
Complex Nursing Interventions.
Behavioral Health Care.
Medication Management, Teaching and Assessment (MMTA).
Under the PDGM, we proposed that each 30-day period would be placed
into one of three functional impairment levels. The level would
indicate if, on average, given the HHA's responses on certain
functional OASIS questions, a 30-day period was predicted to have
higher costs or lower costs. For each of the six clinical groups, we
proposed that total periods would be further classified into one of
three functional impairment levels with roughly 33 percent of total 30-
day periods for all HHAs in each level. We determined how many periods
of care would be in each functional impairment level based on the
relative number of periods in a potential impairment level, and on the
clustering of summed functional scores. The functional impairment level
assignment under the PDGM is very similar to the functional level
assignment in the current payment system.
Finally, we proposed that 30-day periods would receive a
comorbidity adjustment category based on the presence of secondary
diagnoses. We proposed that, depending on a patient's secondary
diagnoses, a 30-day period may receive ``no'' comorbidity adjustment, a
``low'' comorbidity adjustment, or a ``high'' comorbidity adjustment.
For low-utilization payment adjustments (LUPAs) under the PDGM, we
proposed that the LUPA threshold would vary for a 30-day period under
the PDGM depending on the PDGM payment group to which it was assigned.
For each payment group, we proposed to use the 10th percentile value of
visits to create a payment group specific LUPA threshold with a minimum
threshold of at least 2 visits for each group.
The proposed rule further outlined the data file construction
process for the PDGM-related analyses, including the claims data used,
how the data were cleaned, how OASIS data were matched to claims data,
how measures of resource use were constructed, and the total number of
30-day periods used for constructing the PDGM case-mix weights in the
proposed rule (82 FR 35297 through 35298).
The following is a summary of general comments received on the
proposals and our responses.
Comment: Several commenters supported various elements of PDGM.
There was broad support for moving from the current payment system to
one that uses a broader clinical profile of the patient. There was also
support for the budget neutral implementation of the PDGM and the
elimination of the service utilization domain (that is, therapy
thresholds). Other commenters indicated they supported the PDGM, but
stated that implementation of the PDGM should be delayed until after
January 1, 2020 to provide assurances that there is sufficient
information and guidance to HHAs, physicians, and Medicare
Administrative Contractors (``MACs'') to ensure a smooth transition and
no unintended consequences. Commenters also suggested that CMS
implement the model incrementally or conduct a small scale
demonstration of the model.
Response: We thank the commenters for their support. Section
1895(b)(2)(B) of the Act, as added by section 51001(a)(1) of the BBA of
2018, requires the Secretary to apply a 30-day unit of service (also
referred to as unit of payment), effective January 1, 2020. In
addition, section 1895(b)(4)(B)(ii) of the Act, as added by section
51001(a)(3)(B) of the BBA of 2018, requires CMS to remove therapy
thresholds from the case-mix adjustment methodology used to adjust
payments under the HH PPS for CY 2020 and subsequent years. The PDGM
was developed in conjunction with a 30-day period of care and should be
implemented simultaneously with the change in the length of the unit of
[[Page 56448]]
service. Attempting to implement the PDGM piecemeal could cause more
burden and confusion, compared to implementing the entire model at the
same time. With regards to conducting a demonstration, we note that a
demonstration would likely only occur in selected areas with selected
participants and therefore would paint a different picture of the
effects of the model compared to what would otherwise occur on a
national scale. Furthermore, section 1895 of the Act, as amended by the
BBA of 2018, requires a change to the unit of payment and the
elimination of therapy thresholds for all payments made under the HH
PPS, rather than requiring CMS to conduct a demonstration. While we are
finalizing our proposal to implement the PDGM beginning on January 1,
2020, we are sensitive to the concerns expressed by commenters
regarding provider outreach, training, billing changes and systems
updates needed to implement the PDGM. While we work toward an
implementation date of January 1, 2020, we look forward to a continued
dialogue with the industry on ways to provide sufficient guidance and
training to ensure a smooth transition to the 30-day unit of payment
and the PDGM.
Comment: Several commenters asked about what types of training
material will be available regarding the PDGM. A commenter asked if and
when the claims processing manual will be updated to reflect the PDGM.
Additionally, a commenter asked if CMS could develop an email mailbox
for patients to offer feedback on the PDGM.
Response: We appreciate comments about the need for guidance and
training prior to the implementation of the PDGM. We agree with the
commenters that this is an area that deserves attention and we plan to
work with HHAs and other stakeholders to ensure a smooth transition
between the current payment model and the PDGM. We will update the
claims processing manual and we will provide education and support more
broadly, which may include MLN articles, program instructions, national
provider calls, and open door forums. Once the rule is finalized, we
will begin updating the appropriate sections of the Home Health Agency
Billing chapter in the Medicare Claims Processing Manual. For questions
about the Home Health Prospective Payment System (HH PPS) and the
Medicare home health benefit, individuals can email:
[email protected].
Comment: Several commenters asked how CMS would monitor the PDGM.
Specifically, commenters expressed concern that the PDGM may result in
inappropriate practice patterns and that the PDGM might introduce
claims processing issues that could cause delays in payment. A few
commenters also indicated that the technical expert panel (TEP)
convened in February, 2018 should continue to stay involved with the
implementation and roll-out of the PDGM in order to monitor outcomes.
Response: 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. CMS will also carefully pay attention
to claims processing changes needed to implement the 30-day unit of
payment and the PDGM in order to mitigate any issues that could cause
delays in payment. We appreciated the help of the TEP and, if needed,
we will continue to engage the TEP or another set of key stakeholders
as we move forward with the implementation of the PDGM for January 1,
2020.
Comment: Commenters stated there was limited involvement with the
industry in the development of the PDGM. Some commenters indicated that
CMS needs to perform studies and an evaluation of the work related to
the PDGM and alternative payment models suggested, like the ``Risk-
Based Grouper Model''.
Response: We thank the commenters' for their willingness to engage
in discussion around the PDGM. Through notice and comment rulemaking
and other processes, stakeholders always have the opportunity to reach
out to CMS and provide suggestions for improvement in the payment
methodology under the HH PPS. In the CY 2014 HH PPS final rule, we
noted that we were continuing to work on improvements to our case-mix
adjustment methodology and welcomed suggestions for improving such
methodology as we continued in our case-mix research (78 FR 72287). The
analyses and the ultimate development of an alternative case-mix
adjustment methodology were shared with both internal and external
stakeholders via technical expert panels, clinical workgroups, and
special open door forums. We also provided high-level summaries on our
case-mix methodology refinement work in the HH PPS proposed rules for
CYs 2016 and 2017 (80 FR 39839, and 81 FR 76702). A detailed technical
report was posted on the CMS website in December of 2016, additional
technical expert panel and clinical workgroup webinars were held after
the posting of the technical report, and a National Provider call
occurred in January 2017 to further solicit feedback from stakeholders
and the general public. The CY 2018 HH PPS proposed rule further
solicited comments on a proposed alternative case-mix adjustment
methodology--referred to as the home health groupings model, or HHGM.
On February 1, 2018, CMS convened another TEP to gather
perspectives and identify and prioritize recommendations from industry
leaders, clinicians, patient representatives, and researchers with
experience with home health care and/or experience in home health
agency management regarding the case-mix adjustment methodology
refinements described in the CY 2018 HH PPS proposed rule (82 FR
35270), and alternative case-mix models submitted during 2017 as
comments to the CY 2018 HH PPS proposed rule. During the TEP, there was
a description and solicitation of feedback on the components of the
proposed case-mix methodology refinement, such as resource use, 30-day
periods, clinical groups, functional levels, comorbidity groups, and
other variables used to group periods into respective case-mix groups.
Also discussed were the comments received from the CY 2018 HH PPS
proposed rule, the creation of case-mix weights, and an open discussion
to solicit feedback and recommendations for next steps. This TEP
satisfied the requirement set forth in section 51001(b)(1) of the BBA
of 2018, which requires that at least one session of such a TEP be held
between January 1, 2018 and December 31, 2018. In addition, section
51001(b)(3) of the BBA of 2018 requires the Secretary to issue a report
to the Committee on Ways and Means and Committee on Energy and Commerce
of the House of Representatives and the Committee on Finance of the
Senate on the recommendations from the TEP members, no later than April
1, 2019. This report has already been completed and is available on the
CMS HHA Center web page at: https://www.cms.gov/center/provider-Type/
home-Health-Agency-HHA-Center.html. CMS addressed the Risk Based
Grouper Model in the report to the Committee on Ways and Means and
Committee on Energy and Commerce of the House of Representatives and
the Committee on Finance of the Senate on the recommendations from the
TEP members. Lastly, the CY 2019 HH PPS proposed rule solicited comment
on the proposed PDGM.
Comment: Several commenters requested that CMS describe how the
[[Page 56449]]
proposed PDGM would impact delivery and payment innovations, such as
Accountable Care Organizations (ACOs) and Bundled Payments for Care
Improvement (BPCI) Models 2 and 3. Other commenters requested that CMS
describe how the proposed PDGM fits in with the IMPACT Act-directed
post-acute care PPS and other payment system methodology changes in
other settings. Other commenters indicated that the PDGM would hurt
HHVBP and the star ratings. A commenter asked if the Review Choice
Demonstration was still needed if PDGM was implemented and indicated
that would cause additional burden.
Response: BPCI Models 2 and 3 ended September 30, 2018; therefore,
BPCI Models 2 and 3 would not be affected by PDGM implementation. CMS
will determine whether any refinements are needed to the BPCI Advanced
Model, a new payment and service delivery model that began on October
1, 2018, and any ACO programs and models, such as the Medicare Shared
Savings Program and the Next Generation ACO Model as a result of PDGM
implementation. We note that any changes determined to be necessary to
the payment methodology used in the Medicare Shared Savings Program due
to implementation of the PDGM would require notice and comment
rulemaking.
We believe that the proposed PDGM could assist with meeting the
IMPACT Act requirement that the Secretary of Health and Human Services
develop a technical prototype for a unified post-acute care (PAC)
prospective payment system (PAC PPS). We believe many aspects of the
PDGM could be used in a unified PAC PPS prototype so that payments
under such a prototype would be based according to individual
characteristics, as specified by the IMPACT Act. We do not believe that
the PDGM will disrupt the HHVBP Model or the Home Health star ratings.
The PDGM is a case-mix adjustment model intended to pay for services
more accurately and we believe the HHVBP Model and the Home Health star
ratings can continue unchanged when HHA periods of care are paid
according to the case-mix adjustments of the PDGM. We do not believe
the implementation of the PDGM will eliminate the rationale behind the
proposed Review Choice Demonstration for Home Health Services. The PDGM
is a case-mix adjustment model with the goal of better aligning home
health payments with patient care needs and the cost of care, while the
proposed Review Choice Demonstration for Home Health Services would be
a demonstration aimed at assisting in the development of improved
procedures to identify, investigate, and prosecute potential Medicare
fraud occurring among HHAs providing services to Medicare
beneficiaries.
Comment: A commenter asked CMS to provide greater detail about the
appeals process that will be available to help patients address any
shortcomings in their care and/or coverage. In addition, the commenter
stated that providers also should be able to appeal any inaccurate
assignments to payment classifications.
Response: The Advance Beneficiary Notice of Noncoverage (ABN) is
issued by providers (including home health agencies and hospices),
physicians, practitioners, and other suppliers to Original Medicare
(fee-for-service) beneficiaries in situations where Medicare payment is
expected to be denied for some or all services. When a home health
patient gets an ABN, the ABN gives clear directions for getting an
official decision from Medicare about payment for home health services
and supplies and for filing an appeal. An HHA must also furnish a
``Home Health Change of Care Notice'' (HHCCN) to beneficiaries when the
beneficiary's home health plan of care is changing because the Agency
reduces or stops providing home health services or supplies for
business-related reasons or because the beneficiary's physician changed
orders for such services or supplies. An HHA must also furnish a
``Notice of Medicare Non-Coverage'' (NOMNC) at least 2 days before all
covered services end. When home health services are ending,
beneficiaries may have the right to an expedited appeal if they believe
the services are ending too soon. During an expedited appeal, a
Beneficiary and Family Centered Care Quality Improvement Organization
(BFCC-QIO) will examine the case and decide whether home health
services need to continue. If the beneficiary is dissatisfied with the
determination by the QIO, in accordance with Sec. 405.1204, the
beneficiary has the right to an expedited reconsideration by a
Qualified Independent Contractor (QIC). If the beneficiary is
dissatisfied with the determination by the QIC, the beneficiary then
has the right to request an Administrative Law Judge hearing or review
of a dismissal, Medicare Appeals Council review, and judicial review by
a federal district court, so long as jurisdictional requirements are
met (as outlined by 42 CFR part 405, subpart I).
With regards to inaccurate assignments to payment classifications
under the PDGM, corrections to payment classifications on claims will
not require appealing the initial determination. Because the assignment
of the payment classification will be performed by the claims system
based on data reported by the HHA on the claim or the corresponding
patient assessment, the provider could correct this information to
change the assignment. The HHA could submit a correction OASIS
assessment and subsequently adjust their claim after the corrected
assessment is accepted, or simply correct the payment-related items on
the claim (occurrence code, diagnosis code, etc.) and submit the
adjusted claim.
Comment: Another commenter asked CMS to review the current therapy
assessment burden for providers and the time points in which those
assessments need to be completed given that the PDGM does not use a
service utilization domain.
Response: Prior to January 1, 2015, therapy reassessments were
required to be performed on or ``close to'' the 13th and 19th therapy
visits and at least once every 30 days (75 FR 70372). As a reminder, in
the CY 2015 HH PPS final rule, CMS eliminated the requirement for
reassessments to be performed on or ``close to'' the 13th and 19th
visits. Instead, the current regulations at Sec. 409.44(c)(2)(B)
require a qualified therapist (instead of an assistant) to provide the
needed therapy service and functionally reassess the patient at least
every 30 days. Where more than one discipline of therapy is being
provided, a qualified therapist from each of the disciplines must
provide the needed therapy service and functionally reassess the
patient.
Comment: A commenter indicated that under the PDGM those HHAs with
lower margins will be paid less and those HHAs with higher margins will
be paid more. Another commenter indicated that there should be a site
of service adjustment for patients in assisted living as their needs
are greater.
Response: The goal of the PDGM is to more closely align payments
with costs based on patient characteristics. The PDGM was not designed
to help agencies achieve any particular margin. While a commenter noted
that patients in assisted living facilities may have greater needs, we
also note that an HHA may have lower costs when treating multiple
patients within the same assisted living facility due to economies of
scale (lower per visit costs due to transportation and other overhead
costs spread over more visits). We will analyze data after
implementation of the PDGM to determine whether a site of
[[Page 56450]]
service adjustment may be warranted in the future.
Comment: Another commenter asked if CMS would reimburse 30-day
periods without a skilled visit when a skilled visit exists for the 60-
day episode and certification period.
Response: Current regulation at Sec. 409.45(a) does not permit
coverage of dependent services (home health aide services, medical
social services, occupational therapy, durable medical equipment,
medical supplies, or intern and resident services) furnished after the
final qualifying skilled service (skilled nursing; physical therapy;
speech-language pathology; or a continuing occupational therapy after
the need for skilled nursing, physical therapy and/or speech-language
pathology services have ceased), except when the dependent service was
not followed by a qualifying skilled service as a result of the
unexpected inpatient admission or death of the beneficiary, or due to
some other unanticipated event. We did not propose to change the
regulation regarding coverage of dependent services after qualifying
skilled services have ceased in this rule. Therefore, we would not pay
30-day periods without a qualifying skilled service. Furthermore, HHAs
should not be billing for dependent services that occur after the last
qualifying skilled service, unless such services occurred due to an
unexpected inpatient admission or death of the beneficiary, or due to
some other unanticipated event.
Comment: A commenter asked whether CMS would give guidance to MA
plans to implement the PDGM. Another commenter asked how Medicare as a
secondary payer would be impacted by the PDGM.
Response: We acknowledge that some Medicare Advantage plans could
change their payment models to mirror PDGM, while others may not change
their payment models in relation to the changes finalized in this rule.
It should be noted that, as private plans, Medicare Advantage plans do
not have to use the FFS payment methodology. Medicare Advantage payment
models for home health currently take a wide variety of forms and some
may already be approximating the structure of PDGM, using patient
characteristics rather than service utilization as the basis for
payment. We will work generally with stakeholders, including these
private plans, to help ensure that adequate education and resources are
available for all parties. The implementation of the PDGM will have no
impact on the Medicare as a secondary payer process.
Final Decision: We are finalizing the change in the unit of payment
from 60 days to 30 days, effective for 30-day periods of care that
start on or after January 1, 2020, as proposed and in accordance with
the provisions in the BBA of 2018. In addition, we are finalizing the
PDGM, with modification, also effective for 30-day periods of care that
start on or after January 1, 2020. We are also finalizing the
corresponding regulations text changes as described in section III.F.13
of this final rule with comment period. We will provide responses to
more detailed comments regarding the PDGM and the calculation of the
30-day budget neutral payment amount for CY 2020 further in this final
rule with comment period.
2. Methodology Used To Calculate the Cost of Care
To construct the case-mix weights for the PDGM proposal, the costs
of providing care needed to be determined. A Wage-Weighted Minutes of
Care (WWMC) approach is used in the current payment system based on
data from the BLS. However, we proposed to adopt a Cost-per-Minute plus
Non-Routine Supplies (CPM+NRS) approach, which uses information from
HHA Medicare cost reports and home health claims. Under the proposed
PDGM, we group periods of care into their case-mix groups taking into
account admission source, timing, clinical group, functional level, and
comorbidity adjustment. From there, the average resource use for each
case-mix group dictates the group's case-mix weight. We proposed that
resource use is the estimated cost of visits recorded on the home
health claim plus the cost of NRS recorded on the claims. The cost of
NRS is generated by taking NRS charges on claims and converting them to
costs using a NRS cost to charge ratio that is specific to each HHA.
When NRS is factored into the average resource use, NRS costs are
reflected in the average resource use that establishes the case-mix
weights. Similar to the current system, NRS would still be paid
prospectively under the PDGM, but the PDGM eliminates the separate
case-mix adjustment model for NRS. See the proposed rule for more
detail on the steps used to generate the measure of resource use under
the proposed CPM+NRS approach (83 FR 32385 through 32388).
The following is a summary of the public comments received on the
``Methodology Used to Calculate the Cost of Care'' proposal and our
responses.
Comment: Several commenters objected to the use of Medicare cost
report data rather than Wage-Weighted Minutes of Care (WWMC) in the
methodology used to calculate the cost of care. Commenters indicated
that HHAs' inputs, as demonstrated through cost reports, are not
accurately reflecting the effects of changes in utilization, provider
payments, and provider supply that have occurred over the past decade.
They argue that the strength and utility of episode-specific cost
depends on the accuracy and consistency of agencies' reported charges,
cost-to-charge ratios, and episode minutes and that there are no
incentives for ensuring the accuracy of their cost reports; and
therefore the data are presumptively inaccurate. Several commenters
also indicated that the use of cost report data in lieu of WWMC favors
facility-based agencies because they have the ability to allocate
indirect overhead costs from their parent facilities to their service
cost and argue that the PDGM will reward inefficient HHAs with
historically high costs. Finally, a few commenters indicated that they
would support the CPM+NRS approach only if HHA cost reports were
audited.
Response: 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 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 note the
correlation coefficient between the two approaches to calculating
resource use is equal to 0.8537 (n=8,521,924). Correlation coefficients
are used in statistics to measure how strong the relationship is
between two variables. The closer to 1 the stronger the relationship
(zero means no relationship). Therefore, the relationship between using
the CPM+NRS approach compared to the WWMC approach is very similar. In
conjunction with this final rule with comment period, we posted an
excel file on the HHA Center page that includes the case-mix weights
produced using the proposed CPM+NRS approach and those produced using
the current
[[Page 56451]]
WWMC approach in calculating resource use.\10\ The correlation
coefficient between the two sets of weights (CPM+NRS versus WWMC using
BLS data) is 0.9806, meaning the two methods produce very similar case-
mix weights.
---------------------------------------------------------------------------
\10\ https://www.cms.gov/center/provider-Type/home-Health-
Agency-HHA-Center.html.
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In response to comments regarding the accuracy of HHA Medicare cost
report data, as we indicated in the proposed rule, we applied the
trimming methodology described in detail in the ``Analyses in Support
of Rebasing & Updating Medicare Home Health Payment Rates'' Report
available at: https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf. This is also the trimming
methodology outlined in the CY 2014 HH PPS proposed rule (78 FR 40284)
in determining the rebased national, standardized 60-day episode
payment amount. For each discipline and for NRS, we also followed the
methodology laid out in the ``Rebasing Report'' by trimming out values
that fall in the top or bottom 1 percent of the distribution across all
HHAs. This included the cost per visit values for each discipline and
NRS cost-to-charge ratios that fall in the top or bottom 1 percent of
the distribution across all HHAs. Normalizing data by trimming out
missing or extreme values is a widely accepted methodology both within
CMS and amongst the health research community. In eliminating missing
or questionable data with extreme values from the data we obtain a more
robust measure of average costs per visit that is reliable for the
purposes of establishing base payment amounts and case-mix weights
under the HH PPS. Using HHA Medicare cost report data to establish the
case-mix relative weight aligns with the use of this data in
determining the base payment amount under the HH PPS. Furthermore, we
would note that each HHA Medicare cost report is required to be
certified by the Officer or Director of the home health agency as being
true, correct, and complete, with potential penalties should any
information in the cost report be a misrepresentation or falsification
of information. The HHA Medicare Cost Report (MCR) Form (CMS-1728-94)
with this certification statement is available at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1728-94.html.
As always, we encourage providers to fill out the Medicare cost
reports as accurately as possible. We remind the industry again that
each home health cost report is required to be certified by the Officer
or Director the home health agency. We also welcome suggestions for
improving compliance and accuracy on cost reports within the current
cost reporting forms. We will explore whether it is feasible to provide
some sort of national, mandatory training on completing the Medicare
HHA cost report form and whether and to what extent CMS can conduct
more desk reviews and audits of Medicare HHA cost reports in the
future.
With regards to the case-mix weights rewarding inefficient
providers with high costs or facility-based HHAs, each HHA's costs
impact only a portion of the calculation of the weights and costs are
blended together across all HHAs. To put it simply, the payment
regression was estimated using 8,521,924 30-day periods from 10,522
providers. On average, each provider contributed 841 30-day periods to
the payment regression, which is only 0.010 percent of all 30-day
periods. Therefore, including or excluding any single HHA on average
would not dramatically impact the results of the payment regression.
Additionally, in the PDGM, we estimate the payment regression using
provider-level fixed effects; therefore we are looking at the within
provider variation in resource use. That is, we may find there are two
HHAs with different cost structures (for example, HHA ``A'') has costs
that are on average 1.5 times as high as HHA ``B'') but both HHAs can
still have similar patterns in resource use across their 30-day
periods. Since the PDGM is controlling for the variation in the general
costs for HHAs with high and lower costs, including those that have
variation in costs due to being facility-based versus freestanding, we
do not agree that using the CPM+NRS approach in estimating resource use
introduces a bias that favors inefficient or facility-based HHAs.
Comment: Several commenters stated that Non-Routine Supplies (NRS)
should not be incorporated into the base rate and then wage-index
adjusted. The industry stated that HHAs' supply costs are approximately
the same nationally, regardless of rural or urban locations and
regardless of the wage-index. Commenters stated that including NRS in
the base rate will penalize rural providers and unnecessarily overpay
for NRS in high wage-index areas. Another commenter indicated that CMS
should lower the labor-related share to account for NRS in the base
payment rate.
Response: As we noted in the CY 2008 HH PPS final rule with
comment, use of NRS is unevenly distributed across episodes of care in
home health. In addition, the majority of episodes do not incur any NRS
costs and, at that time, the current payment system overcompensated for
episodes with no NRS costs. We found that patients with certain
conditions, many of them related to skin conditions, were more likely
to require high non-routine medical supply utilization (72 FR 49850).
We noted in the CY 2008 HH PPS proposed rule that, in particular,
commenters were concerned about the adequacy of payment for some
patients with pressure ulcers, stasis ulcers, other ulcers, wounds,
burns or trauma, cellulitis, and skin cancers (72 FR 25427). At that
time (and currently), the clinical levels for the HH PPS did not group
patients with similar supply needs together; therefore, for CY 2008 we
created a separate case-mix adjustment process for NRS based on a NRS
conversion factor and six severity levels. We noted that the NRS case-
mix adjustment process did not have a high degree of predictive
accuracy, possibly due to the limited data available to model NRS costs
and the likelihood that OASIS does not have any measures available for
some kinds of NRS. We stated in the CY 2008 HH PPS final rule that we
would continue to look for ways to improve our approach to account for
NRS by exploring alternative methods for accounting for NRS costs and
payments in the future (72 FR 25428). 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 into two
groups--the Wound group and the Complex Nursing Interventions group.
For example, while the Wound group and Complex Nursing Interventions
groups comprise about 10 percent and 4 percent of all 30-day periods of
care, respectively; roughly 30 percent of episodes where NRS was
supplied was for Wound and Complex Nursing Interventions groups and 47
percent of NRS charges fall into the Wound and Complex Nursing
Interventions groups. We note that CY 2017 claims data indicates that
about 71 percent of 60-day episodes did not provide any NRS.
As noted by the commenters, in the CY 2008 HH PPS proposed rule we
stated that because the market for most NRS is national, we proposed
not to have a geographic adjustment to the conversion factor (72 FR
25430). More accurately, because the NRS conversion factor reflected
supplies and not wage and wage-related costs, we did not subject NRS
payments to the geographic wage adjustment process. However, we
[[Page 56452]]
note that we did not revise the labor-related share to reflect the
exclusion of NRS payments from the national, standardized 60-day
episode payment amount. The labor-related share (LRS), effective for CY
2013 to CY 2018 home health payments of 78.535 percent is based on the
2010-based HHA market basket where the LRS is equal to the compensation
cost weight, including salaries, benefits, and direct patient care
contract labor. The non-labor-related share of 21.465 includes the
relative costs for the NRS supplies. For comparison purposes, if we had
removed NRS supplies from the calculations in the 2010-based Home
Health market basket, the LRS would have been 79.7 percent and the non-
labor-related share would have been 20.4 percent. Again, the LRS of
78.535 percent did not include NRS costs and therefore, NRS was not
subjected to the geographic adjustment as it does not reflect wage and
wage related costs. Similarly, the CY 2019 LRS of 76.1 percent, based
on the 2016-based HHA market basket, also does not include NRS.
Comment: A few commenters stated that based on their operational
experiences with clinical staffing labor costs, HHA cost report data
suggests more parity exists between skilled nursing (``SN'') versus
physical therapist (``PT'') costs than in fact exists. Commenters
stated that BLS data showing a 40 percent difference between SN and PT
costs are more reflective of the commenters' human resources/staffing
experiences in the markets where they operate. As such, commenters
believe the use of cost report data would cause the PDGM model to
overpay for nursing services and underpay for therapy services. A
commenter indicated that contract staff are more expensive than staff
that are hired and indicated this will widen the gap between nursing
and therapy costs.
Response: The HHA Medicare cost report data reflects all costs and,
most importantly, it reflects all labor costs, including contract labor
costs. The BLS data only reflects employed staff. This may at least
partially explain why a 40 percent variation between SN and PT costs is
not evident in the cost report data. The HHA Medicare cost report data
shows about a 20 percent difference between PT and SN compensation
costs (wages and salaries, employee benefits and contract labor) per
visit, which is consistent with the difference between PT and SN total
costs per visit. Moreover, in aggregate, about 15 percent of
compensation costs are contract labor costs and this varies among type
of visit with contract labor costs accounting for a much higher
proportion of therapy visit compensation costs compared to skilled
nursing visit compensation cost. Utilization also varies among
freestanding providers with smaller providers having a higher
proportion of contract labor costs, particularly for therapy services
compared to larger providers. It also seems to vary by region. The
decision of whether to/or what proportion of contract labor to use is
at the provider's discretion. In regards to the comment on expense of
contracted services, we note that using cost report data allows those
types of relationships to be fully measured. Finally, we note that in
order to be eligible for Medicare HH PPS payments, providers must
complete the HHA Medicare cost report; therefore, if providers are
required to complete the cost report, then we believe such data are
appropriate to use for payment purposes.
Comment: Several commenters indicated that WWMC and CPM+NRS results
should be blended together to minimize disruptions.
Response: CMS appreciates this suggestion. However, there are
difficulties in blending due to the WWMC and CPM+NRS approaches
measuring different outcomes. WWMC is focused on cost of labor while
CPM+NRS takes a more diverse approach and accounts for labor, overhead,
and NRS. As discussed previously, there is very high correlation
between the two approaches, meaning they produce very similar weights.
Comment: Another commenter indicated costs related to enrollment
should be included in the calculation of resource use.
Response: These costs may be included in staffing and overhead
costs and, if so, would be captured by the CPM+NRS approach.
Comment: A commenter cited a report that indicated for ``on-the-job
activities undertaken by employees, HHS Guidelines recommend using
estimates of pre-tax wages for the particular industry and affected
occupation, to the extent possible, and adding estimate of benefits and
indirect costs.''
Response: The goal of the CPM+NRS methodology is to not simply
measure costs related to on-the-job activities. In order to account for
a broader array of costs, which is necessary to assign accurate payment
rates, we instead used information from cost reports which is more
detailed than information on wages, benefits, and indirect cost.
Final Decision: We are finalizing our proposal to adopt a Cost-per-
Minute plus Non-Routine Supplies (CPM+NRS) approach in estimating
resource use, which uses information from HHA Medicare cost reports.
The following steps would be used to generate the measure of resource
use under the CPM+NRS approach:
(1) From the cost reports, obtain total costs for each of the six
home health disciplines for each HHA.
(2) From the cost reports, obtain the number of visits by each of
the six home health disciplines for each HHA.
(3) Calculate discipline-specific cost per visit values by dividing
total costs [1] by number of visits [2] for each discipline for each
HHA. For HHAs that do not have a cost report available (or a cost
report that was trimmed from the sample), imputed values are used as
follows:
A state-level mean is used if the HHA was not hospital-
based. The state-level mean is computed using all non-hospital based
HHAs in each state.
An urban nationwide mean is used for all hospital-based
HHAs located in a Core-based Statistical Area (CBSA). The urban nation-
wide mean is computed using all hospital-based HHAs located in any
CBSA.
A rural nationwide mean is used for all hospital-based
HHAs not in a CBSA. The rural nation-wide mean is computed using all
hospital-based HHAs not in a CBSA.
(4) From the home health claims data, obtain the average number of
minutes of care provided by each discipline across all episodes for a
HHA.
(5) From the home health claims data, obtain the average number of
visits provided by each discipline across all episodes for each HHA.
(6) Calculate a ratio of average visits to average minutes by
discipline by dividing average visits provided [5] by average minutes
of care [4] by discipline for each HHA.
(7) Calculate costs per minute by multiplying the HHA's cost per
visit [3] by the ratio of average visits to average minutes [6] by
discipline for each HHA.
(8) Obtain 30-day period costs by multiplying costs per minute [7]
by the total number of minutes of care provided during a 30-day period
by discipline. Then, sum these costs across the disciplines for each
period.
NRS costs are added to the resource use calculated in [8] in the
following way:
(9) From the cost reports, determine the NRS cost-to-charge ratio
for each HHA. Imputation for missing or trimmed values is done in the
same manner as it was done for cost per visit (see [3] as previously
indicated).
[[Page 56453]]
(10) From the home health claims data, obtain NRS charges for each
period.
(11) Obtain NRS costs for each period by multiplying charges from
the home health claims data [10] by the cost-to-charge ratio from the
cost reports [9] for each HHA.
Resource use is then obtained by:
(12) Summing costs from [8] with NRS costs from [11] for each 30-
day period.
3. Change From a 60-Day to a 30-Day Unit of Payment
a. Background
Currently, HHAs are paid for each 60-day episode of home health
care provided. By examining the resources used within a 60-day episode
of care, we identified differences in resources used between the first
30-day period within a 60-day episode and the second 30-day period
within a 60-day episode. Episodes have more visits, on average, during
the first 30 days compared to the last 30 days. Costs are much higher
earlier in the episode and lesser later on, therefore, dividing a
single 60-day episode into two 30-day periods more accurately
apportions payments. In addition, with the removal of therapy
thresholds from the case-mix adjustment methodology under the HH PPS, a
shorter period of care reduces the variation and improves the accuracy
of the case-mix weights generated under the PDGM.
Section 1895(b)(2)(B) of the Act, as added by section 51001(a)(1)
of the BBA of 2018, requires the Secretary to apply a 30-day unit of
service for purposes of implementing the HH PPS, effective January 1,
2020. We note that we interpret the term ``unit of service'' to be
synonymous with ``unit of payment'' and will henceforth refer to ``unit
of payment'' in this final rule with comment period with regards to
payment under the HH PPS. Therefore, in accordance with section
1895(b)(2)(B) of the Act, we proposed changing the unit of payment from
a 60-day episode of care to 30-day unit of payment, effective January
1, 2020.
Comment: Many commenters understood the requirement for CMS to
change from a 60-day episode to a 30-day unit of payment. Several
commenters appreciated that CMS was maintaining the existing 60-day
timing for comprehensive assessments, certifications and
recertifications, and plans of care. Some commenters expressed concern
that the 30-day payment period was more confusing because it is on a
different a timeline than for other home health requirements such as
the certification/recertification, OASIS assessments and updates to the
plan of care.
Response: CMS thanks commenters for recognizing that the change
from a 60-day unit of payment to a 30-day unit of payment is required
by law and we do not have the discretion to implement a different
policy. We believe that changing to a 30-day unit of payment will more
accurately pay for services in accordance with patient characteristics
and is a better approach to focus on patient care needs. We believe
maintaining the existing timeframes for updates to the comprehensive
assessment, updates to the plan of care, and recertifications will help
make the transition to a new case-mix adjustment methodology more
seamless for HHAs. Under the PDGM, the initial certification of patient
eligibility, plan of care, and comprehensive assessment are valid for
two 30-day periods of care (that is, for 60 days of home health care)
in accordance with the home health regulations at 42 CFR 409.43 and
424.22, and the home health CoPs at 42 CFR 484.55. Each
recertification, care plan update, and comprehensive assessment update
will also be valid for two 30-day periods of care, also in accordance
with the home health regulations at 42 CFR 409.43(e) and 424.22(b), and
the home health CoPs at 484.60(c).
We also note that not all home health requirements have a 60-day
timeframe. For example, OASIS reporting regulations require the OASIS
to be completed within 5 days and transmitted within 30 days of
completing the assessment of the beneficiary. In addition, physical,
occupational, and speech therapists must provide the needed therapy
service and functionally reassess the patient at least every 30
calendar days. Home health is not the only care setting where billing
and certifications are not done in the same timeframe. For example,
hospices must certify and recertify patients every 60-90 days and they
bill on a monthly basis. Previous to the inception of the HH PPS, HHAs
also billed on a monthly basis even though the plan of care and
certifications were completed every 60 days.
Comment: Many commenters described the burden that would exist in
switching to a 30-day period. Some commenters indicated their overhead
costs would increase because they would have to double their billing
and CMS should account for those costs. Some commenters believe that
switching to 30-days would result in documentation errors and increased
administrative burdens to both providers and to CMS due to an increase
in claim submissions, resubmissions, and appeals. Some commenters
indicated that switching to a 30-day billing cycle would result in a
need to change current software and would require additional training
for the providers. Commenters remarked they did not have the manpower
to implement this change and that it goes against the Secretary's goal
of reducing burden. Many commenters expressed concern that switching to
a 30-day period would cause undue burden because of the current
difficulty in getting physicians to sign the plan of care in a timely
manner.
Response: Under section 1895(b)(2)(B) of the Act, we are required
to apply a 30-day unit of service for purposes of implementing the HH
PPS, effective January 1, 2020. We appreciate the commenters' concern
regarding burden surrounding the change in the unit of payment from a
60-day episode to a 30-day period. While the change from a 60-day
episode to a 30-day period may increase the billing frequency for final
claims, we note that this change should not result in a measurable
increase in burden, as many of the data elements that are used to
populate an electronic claims submission will remain the same from one
30-day period to the next. HHAs are required to line-item bill each
visit performed and whether each visit is recorded on a single 60-day
claim or the visits are recorded on two different 30-day claims should
not result in a measureable burden increase. Also, current data for CY
2017 suggests that nearly \1/3\ of all 60-day periods would not produce
a second 30-day period and would not require a second bill to be
submitted. The proposed elimination of unnecessary items from the
OASIS, especially those items no longer needed on follow-up assessments
under the PDGM, would result in a decrease in regulatory burden, as
discussed in section V. of this final rule with comment period. We
remind commenters that prior to the inception of the HH PPS, HHAs also
billed on a monthly basis even though the plan of care and
certifications were completed every 60 days. We believe that the 30-day
period is appropriate even if some requirements in home health have 60-
day timeframes as a 30-day period of care under the PDGM better aligns
home health payments with the costs of providing care. While we do not
anticipate any increases in the numbers of appeals because of the
implementation of the PDGM, we plan to conduct training and education
for both HHAs and the MACs on the
[[Page 56454]]
operational aspects of the PDGM to mitigate any issues with claims
submissions, resubmissions, and appeals.
Just like in the current system, under the PDGM, before a provider
submits a final claim, the HHA will need to have a completed OASIS
assessment, signed certification, orders, and plan of care. Our
expectation is that the HHA will obtain the signed physician
certification and plan of care timely. As we have reiterated in
previous rulemaking and in sub-regulatory guidance, the certification
must be complete prior to when an HHA bills Medicare for payment;
however, physicians should complete the certification when the plan of
care is established, or as soon as possible thereafter. This is
longstanding CMS policy as referenced in Pub 100-01, Medicare General
Information, Eligibility, and Entitlement Manual, chapter 4, section
30.1.\11\ As stated in sub-regulatory guidance in the Pub. 100-02,
Medicare Benefit Policy Manual, chapter 7, section, section 30.5.1,
``it is not acceptable for HHAs to wait until the end of a 60-day
episode of care to obtain a completed certification/recertification.''
Per the regulations at Sec. 409.43(c), if the HHA does not have
detailed orders for the services to be rendered, the plan of care must
either be signed or immediately sent to the physician for signature at
the time that the agency submits its request for anticipated payment
(submitted at the start of care after the first visit is performed).
The Conditions of Participation (CoPs) require the Outcome and
Assessment Information Set (OASIS) to be completed within 5 days and
submitted within 30 days of completion. Under the PDGM, the initial
certification of patient eligibility, plan of care, and comprehensive
assessment are valid for two 30-day periods of care. Each
recertification, care plan update, and comprehensive assessment update
will also be valid for two 30-day periods of care.
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\11\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ge101c04.pdf.
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Comment: Another commenter indicated that if there was a 30-day
period then the face-to-face encounter requirement provision could be
eliminated. Another commenter asked if all physicians' orders must be
signed and returned before the HHA can bill the first 30-day period. A
commenter questioned what would occur with episodes where a portion of
the payment started prior to the implementation date of January 1,
2020. Another commenter questioned what would happen if a patient's
diagnosis changes for the second 30-day period, as no additional
comprehensive assessment is required before the second payment period.
Response: The face-to-face requirement is statutorily required
under sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act as part of
the certification for home health services. As a condition of payment
for Medicare home health benefits, a face-to-face encounter must meet
the requirements as set forth at Sec. 424.22(a)(1)(v). The intent of
the face-to-face encounter requirement is to achieve greater physician
accountability in certifying a patient's home health eligibility and in
establishing a patient's plan of care. As such, this requirement is
unrelated to the switch from a 60-day episode to a 30-day period.
Likewise, the requirements for submission of home health claims have
not changed. The regulations at Sec. 409.43 state that in order to
submit a final claim for payment, the plan of care and any physician's
orders must be signed and dated by the physician before the HHA bills
for the care.
For implementation purposes, the 30-day payment amount would be
paid for home health services that start on or after January 1, 2020.
More specifically, for 60-day 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 would be the CY 2020 national, standardized 60-day
episode payment amount. For home health periods of care that begin on
or after January 1, 2020, the unit of payment would now be a 30-day
period and payment made under the Medicare HH PPS would be the CY 2020
national, standardized prospective 30-day payment amount. For home
health periods of care that begin on or after December 2, 2020 through
December 31, 2020 and end on or after January 1, 2021, the HHA would be
paid the CY 2021 national, standardized prospective 30-day payment
amount.
As we have stated, the requirements for when to update the
comprehensive assessment remain unchanged. For example, if the HHA does
not need to update the comprehensive assessment prior to recertifying
the patient (for which the comprehensive assessment would be completed
within the last 5 days of every 60 days beginning with the start of
care date), then responses from the start of care OASIS would be used
for determining the functional impairment level for both the first and
second 30-day periods. The follow-up OASIS completed near the time of
recertification would be used for the third and fourth 30-day periods
of care. If, for example, the HHA needs to complete a resumption of
care OASIS within 48 hours of the patient returning to home health
after being transferred and admitted to the hospital for 24 hours or
more and this occurs during the first 30-day period of care, then the
responses for functional items from the resumption of care assessment
would be used to determine the functional impairment level for the
second 30-day period of care.
With regards to diagnosis codes, the PDGM uses the diagnoses from
the home health claim to group a 30-day home health period of care into
a clinical group and to determine if there is a comorbidity adjustment.
If a home health patient has any changes in diagnoses (either the
principal or secondary), this would be reflected on the home health
claim and the case-mix weight could change accordingly. However, we
would expect that the HHA clinical documentation would also reflect
these changes and any communication/coordination with the certifying
physician would also be documented. The home health CoPs at Sec.
484.60(c) require that the HHA must promptly alert the relevant
physician(s) to any changes in the patient's condition or needs that
suggest that outcomes are not being achieved and/or that the plan of
care should be altered.
b. 30-Day Unit of Payment
Section 1895(b)(3)(A)(iv) of the Act, requires CMS to calculate a
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. As also required by 1895(b)(3)(A)(iv) of
the Act, to calculate a 30-day payment amount in a budget- neutral
manner, we are required to make assumptions about, and take into
account behavior changes that could occur as a result of the
implementation of the 30-day unit of payment and case-mix adjustment
factors 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 application of the home health
applicable percentage increase, the adjustment for case-mix changes,
the adjustment if quality data is not reported, and the productivity
adjustment.
[[Page 56455]]
To calculate the 30-day budget-neutral payment amount, we proposed
three assumptions about behavior change 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: This is based on the principal
diagnosis code for the patient as reported by the HHA on the home
health claim. Our proposed assumption was that HHAs will change their
documentation and coding practices and put the highest paying diagnosis
code as the principal diagnosis code in order to have a 30-day period
be placed into a higher-paying clinical group.
Comorbidity Coding: The PDGM further adjusts payments
based on patients' secondary diagnoses as reported by the HHA on the
home health claim. OASIS only allows HHAs to designate 1 principal
diagnosis and 5 secondary diagnoses while the home health claim allows
HHAs to designate 1 principal diagnosis and 24 secondary diagnoses. Our
proposed assumption was that by taking into account additional ICD-10-
CM diagnosis codes listed on the home health claim (beyond the 6
allowed on the OASIS), more 30-day periods of care will receive a
comorbidity adjustment
LUPA Threshold: Under the proposed PDGM, our proposed
assumption was 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.
If no behavioral assumptions were made, we estimated that the 30-
day payment amount needed to achieve budget neutrality would be
$1,873.91. The clinical group and comorbidity coding assumptions would
result in the need to decrease the budget-neutral 30-day payment amount
to $1,786.54 (a 4.66 percent decrease from $1,873.91). Adding the LUPA
assumption would require us to further decrease that amount to
$1,753.68 (a 6.42 percent decrease from $1,873.91). Because we proposed
to implement the 30-day unit of payment and the PDGM for CY 2020, we
would propose the actual 30-day payment amount in the CY 2020 HH PPS
proposed rule calculated using CY 2018 home health utilization data and
we would calculate this amount before application of the proposed home
health update percentage required for CY 2020 (as required by section
1895(b)(3)(B)(i) of the Act). In the proposed rule, we noted 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 solicited comments on the proposed behavior change assumptions
previously outlined to be used in determining the 30-day payment amount
for CY 2020.
The following is a summary of the public comments received on the
``30-day Unit of Payment'' proposals and our responses.
Comment: Some commenters expressed support for the inclusion of
behavioral assumptions in calculating the budget-neutral 30-day payment
amount. Some commenters stated that using these behavioral assumptions
may help mitigate potential program integrity issues which could cause
disruptions in patient care.
Response: We thank commenters for their remarks supporting the
behavioral assumptions. The purpose of these behavioral assumptions is
not to incorporate a built-in program integrity measure, but rather CMS
is required by law to make behavioral assumptions when calculating a
30-day budget-neutral payment amount for CY 2020. Also as required by
section 1895(b)(3)(D)(i) of the Act, as added by section 51001 of the
BBA of 2018, we will analyze the impact of the assumed versus the
actual behavior change after the implementation of the PDGM and the 30-
day unit of payment to determine if any payment adjustment, either
upward or downward, is warranted. We will monitor utilization trends
after implementation of the PDGM in CY 2020 to identify any aberrant
behavior or significant changes in practice patterns that may signal
potential program integrity concerns and investigate such occurrences
accordingly.
Comment: The majority of commenters stated that CMS should not
apply behavioral assumptions industry-wide as it punishes all HHAs for
the performance of small set of agencies and these commenters expressed
concern over what they describe as an adversarial approach to assumed
behavior changes. Many of the commenters were concerned with the broad
assumption by CMS that HHAs would indulge in ``gaming'' and unethical
behavior to compensate for the changes within the PDGM model. It was
stated that CMS should instead do more targeted program integrity
efforts, such as creating a system of audits and significant monetary
or other punishments, or adjust payments only for HHAs whose
reimbursement falls outside normal variations. It was also suggested
that HHAs that do not actually change their behavior in response to the
PDGM should have a different payment rate structure compared to HHAs
that do change their behavior.
Response: 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;
therefore, these assumptions are not meant to be punitive. We
acknowledge that in making assumptions about provider behavior, no
matter if required by law or well-supported by evidence, there will be
those who will disagree with this type of approach to adjusting
payment. We have addressed in the CY 2016 HH PPS final rule why we do
not believe targeted program integrity efforts would mitigate
behavioral changes resulting from a case-mix system (80 FR 68421). As
we stated in the CY 2016 HH PPS final rule (80 FR 68421 through 68422),
for a variety of reasons, we have not proposed targeted reductions for
nominal case-mix growth, meaning the portion of case-mix growth that
cannot be explained by changes in patient characteristics. The foremost
reason is that we believe changes and improvements in coding have been
widespread, so that such targeting would likely not separate agencies
clearly into high and low coding-change groups. In that same rule, we
referenced an independent review of our case-mix measurement
methodology conducted by Dr. David Grabowski, Ph.D., a professor of
health care policy at Harvard Medical School, and his team agreed with
our reasons for not proposing targeted reductions, stating their
concerns about the small sample size of many agencies and their
findings of significant nominal case-mix across different classes of
agencies (please see the ``Home Health Study Report--Independent Review
of the Models to
[[Page 56456]]
Assess Nominal Case-Mix Growth'', dated June 21, 2011.) \12\
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\12\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/HHPPS_HHAcasemixgrowthFinalReport.pdf.
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While certain commenters seem to assume that CMS can precisely
identify those agencies practicing abusive coding, we do not agree that
agency specific case-mix levels can precisely distinguish the agencies
that engage in abusive coding from all others. System wide, case-mix
levels have risen over time throughout the country, while patient
characteristics data indicate little real change in patient severity
over time. That is, the main issue is not the level of case-mix billed
by any specific HHA over a period of time, but the amount of change in
the billed case-mix weights not attributable to underlying changes in
actual patient severity. Therefore, while commenters provided specific
suggestions for targeted efforts, we are unable to implement such
actions for the reasons described. We note that we have taken various
measures to reduce payment vulnerabilities and the federal government
has launched actions to directly identify fraudulent and abusive
activities. Commenters should be aware of tip lines available that can
help support investigative efforts of the federal government. The
Office of the Inspector General, Department of Health and Human
Services website at: http://oig.hhs.gov/fraud/report-fraud/index.asp,
provides information about how to report fraud. Another website, http://www.stopmedicarefraud.gov/index.html, is oriented to Medicare patients
and their families and provides information about recognizing fraud.
Finally, we remind commenters that section 1895(b)(3)(A)(iv) of the
Act requires that in calculating a 30-day budget-neutral payment
amount, we are required to make assumptions about behavior changes that
could occur as a result of the implementation of the 30-day unit of
payment and a change to the case-mix adjustment methodology; therefore,
we do not have the discretion to apply different policies. Likewise, we
are required to analyze data for CYs 2020 through 2026, after
implementation of the 30-day unit of payment and the alternate case-mix
adjustment methodology, to annually determine the impact of the
differences between assumed behavioral changes and actual behavioral
changes on estimated aggregate expenditures and adjust the payment
amount either upwards or downwards accordingly.
Comment: Several commenters disagreed with the three behavioral
assumptions made and remarked that the assumptions appear to be
randomly determined, inappropriate and that there is no evidence to
support them. A commenter specifically stated that the assumptions lack
any foundation in actual evidence-based data and therefore penalize
providers in an arbitrary and capricious fashion in violation of the
Administrative Procedures Act (APA). A few remarked that the
assumptions are ``mere guesses'' and appear to be used solely to reduce
home health payments. Other commenters remarked that the proposed
behavioral assumptions appear to be overly complex and unsubstantiated.
Some commenters stated the assumptions are illogical because the broad
assumptions in the proposed rule basically construct a completely new
payment system that is predicated on a presumption that HHAs will
attempt to manipulate the system and recommended that the behavioral
assumptions be tested before they are implemented. Many commenters
asked for additional documentation on how the reductions derived from
the three behavioral assumptions were calculated and wanted to know the
specific calculations that were made and the rationale behind those
calculations.
Response: We disagree that the three behavioral assumptions made
are arbitrary, inappropriate, illogical, mere guesses, overly complex,
meant to penalize providers, or that there is no evidence to support
them. Likewise, we disagree that these assumptions are in violation of
the APA given that CMS is required by statute to apply behavioral
assumptions in calculating the 30-day budget-neutral payment amount; we
described such assumptions in notice and comment rulemaking as required
by section 1895(b)(3)(A)(iv) of the Act. Additionally, we examined
relevant data and believe we have a satisfactory explanation for these
assumptions, including a substantive connection between the data and
the behavioral assumptions made. We believe that there is both evidence
for and precedent for adjusting the home health prospective payment
based on assumed behavioral changes.
With regards to our assumption that HHAs would code the highest-
paying diagnosis code as primary for the clinical grouping assignment,
this assumption was based on decades of past experience under the case-
mix system for the HH PPS and other case-mix systems for other payment
systems, such as the implementation of the diagnosis-related groups
(DRGs) and the Medicare Severity (MS)-DRGs under the inpatient
prospective payment system. In the FY 2008 IPPS final rule (72 FR
47176), we noted that case-mix refinements can lead to substantial
unwarranted increase in payments. To address this issue when CMS
transitioned from DRGs to MS-DRGs, MedPAC recommended that the
Secretary project the likely effect of reporting improvements on total
payments and make an offsetting adjustment to the national average base
payment amounts (72 FR 47176). In the FY 2008 IPPS final rule (72 FR
47181), we summarized instances where case-mix increases resulted from
documentation and coding-induced changes for the first year of the IRF
PPS and in Maryland hospitals' transition to APR DRGs (estimated at
around 5 percent in both instances). Therefore, we 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).
In both the FY 2010 and FY 2011 IPPS final rules, subsequent
analysis of claims data, using FYs 2008 and 2009 claims, supported the
prospective payment adjustments to account for the documentation and
coding effects (74 FR 43770 and 75 FR 50356). Specifically, we stated
that based on our retrospective evaluation of claims, our actuaries
determined that the implementation of the MS-DRG system resulted in a
2.5 percent change and a 5.4 percent change in case-mix not due to
actual changes in patient characteristics, but due to documentation and
coding changes for discharges occurring during FYs 2008 and 2009,
respectively. We stated that the coding assumption is appropriate
because, in the absence of such adjustments, the effect of the
documentation and coding changes resulting from the adoption of the MS-
DRGs results in inappropriately high payments because that portion of
the increase in aggregate payments is not due to an increase in patient
severity of illness (and costs).
With regards to experience under the HH PPS, we note that effective
for CY 2008, CMS finalized changes to the HH PPS case-mix model to
reflect different resource costs for early home health episodes versus
later home health episodes and expanded the case-mix variables and
therapy thresholds included in the payment model (72 FR 49764). These
changes resulted in the 153 home health resource groups (HHRGs)
currently used to case-mix adjust payment in the HH PPS. Since the CY
2008 proposed rule, we have stated in HH PPS rulemaking that we would
continue to monitor case-mix
[[Page 56457]]
changes in the HH PPS and to update our analysis to measure change in
case-mix, both nominal and real. As discussed in the CY 2010 HH PPS
rule (74 FR 40958), the analysis then indicated approximately 9.77
percent of the 15.03 percent increase in the overall observed case-mix
between the IPS baseline and 2007 was real, that is, due to actual
changes in patient characteristics. Our estimate was that a 13.56
percent nominal increase (15.03-(15.03 x 0.0977)) in case-mix was due
to changes in coding procedures and documentation rather than to
treatment of more resource-intensive patients (that is, nominal case
mix growth). In the CY 2011 HH PPS proposed rule, we stated from 2000
to 2007, we observed about a 1 percent per year increase in total
average case-mix. However, that annual change increased to slightly
more than 4 percent [4.37 percent] between 2007 and 2008 (75 FR 43238).
Our analyses at that time indicated a 19.40 percent increase in the
overall observed case-mix since 2000 with approximately 10.07 percent
attributed to actual changes in patient characteristics. Our estimate
was that a 17.45 percent nominal increase (19.40-(19.40 x 0.1007)) in
case-mix was due to changes in coding practices and documentation
rather than to treatment of more resource-intensive patients. In the CY
2012 HH PPS proposed rule we stated that our analysis indicated another
large increase in the average case-mix weight between CY 2008 and CY
2009 of 2.6 percent (76 FR 40990), attributable to the CY 2008
refinements. Therefore, analysis of case-mix growth between the two
years immediately after implementation of the CY 2008 refinements
demonstrated that average case-mix increased by nearly 7 percent. Our
latest analysis continues to support the payment adjustments as
outlined in the CY 2018 HH PPS proposed rule (82 FR 35274), which shows
that between CY 2000 and 2010, total case-mix change was 23.90 percent,
with 20.08 considered nominal case-mix growth, an average of
approximately 2 percent nominal case-mix growth per year, including
changes due to the CY 2008 case-mix adjustment methodology refinements.
Therefore, we believe that there is ample evidence supporting the
behavioral assumptions relating to changes, including improvements, in
coding.
Our analysis shows that only about a third of 30-day periods move
into a different clinical group as a result of the clinical group
coding assumption, meaning that the reported secondary diagnosis(es)
would place a period of care into a higher case-mix group under the
PDGM if reported as the principal diagnosis. Clinically, there are
circumstances in which it would be appropriate to report a higher
paying code as the principal diagnosis. For example, if medical
documentation notes that a patient was recently hospitalized for
exacerbation of congestive heart failure (which, if reported as the
principal diagnosis, would group a period of care into the clinical
group, MMTA) and there is expected teaching by the HHA associated with
the recent exacerbation, but the patient also has a stage 2 pressure
ulcer (which, if reported as the principal diagnosis, would group a
period of care into the clinical group, Wounds) that requires wound
care, we believe it would be appropriate to report the pressure ulcer
as the principal diagnosis as the pressure ulcer would likely take
priority as the primary reason for home health care in terms of
increased resource utilization. However, the teaching associated with
the exacerbation of heart failure would be a secondary reason, but
still an important additional reason for home health care, and
congestive heart failure would be reported as an additional diagnosis
on the home health claim. In the current HH PPS, the assignment of
points as part of the clinical level in the case-mix methodology is
dependent upon the reporting of diagnoses. However, the points assigned
are not generally dependent on whether the diagnosis is reported as the
primary diagnosis or other diagnosis, except for a few exceptions. This
means, that for most of the clinical point assignments, the ordering of
the diagnosis does not matter as much as whether the diagnosis is
present or not. For example, if a cancer diagnosis is reported, there
are the same number of associated clinical points regardless of whether
the cancer diagnosis is reported as a principal diagnosis or as a
secondary diagnosis. However, under the PDGM, the ordering of diagnoses
is important in determining the clinical group and the comorbidity
adjustment, so we do expect that HHAs will improve the ordering of
diagnosis codes to ensure that the home health period of care is
representative of patient characteristics and paid accordingly.
Furthermore, the implementation of ICD-10-CM has expanded the diagnosis
code set significantly, making it possible for HHAs to more accurately
and specifically code conditions present in the home health patient
population.
With regards to the comorbidity coding assumption, using the home
health claim for the comorbidity adjustment as opposed to OASIS
provides more opportunity to report all comorbid conditions that may
affect the home health plan of care. The OASIS item set only allows
HHAs to designate up to 5 secondary diagnoses, while the home health
claim (837I institutional claim format-electronic version of the paper
UB-04) allows HHAs to report up to 24 secondary diagnoses.
Additionally, because ICD-10 coding guidelines require reporting of all
secondary diagnoses that affect the plan of care, we would expect that
more secondary diagnoses would be reported on the home health claim
given the increased number of secondary diagnosis fields on the home
health claim compared to the OASIS item set. Therefore, we assume that
by taking into account additional ICD-10-CM diagnosis codes listed on
the home health claim, 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. Furthermore, because
the comorbidity adjustment in the PDGM can increase payment by up to 20
percent, we assume that HHAs will ensure that secondary diagnoses
affecting the home health plan of care would be reported to more
accurately identify the conditions affecting resource use.
Regarding the LUPA threshold assumption, as noted in the FY 2001 HH
PPS final rule, the episode file showed that approximately 16 percent
of episodes would have received a LUPA (65 FR 41162). However,
currently, only about 7 percent of all 60-day episodes receive a LUPA.
In other words, it appears HHAs changed practice patterns such that
more than half of 60-day episodes that would have been LUPAs upon
implementation of the HH PPS are now non-LUPAs. Current data for CY
2017 suggest that what would be about one-third of the LUPA episodes
with visits near the LUPA threshold would move up to become non-LUPA
episodes as we currently see clustering of episodes at and around the
current LUPA threshold of 5 visits. Under the current 60-day episode
structure, there is a natural breaking point in the distribution of
episodes between those with 4 or fewer visits (LUPAs) and those with 5
or more visits (non-LUPAs). The distribution around this breaking point
of episodes as a percent of total episodes has remained fairly constant
over the last few years. In particular, the episodes with 2, 3, or 4
visits are similar, with each comprising about 2.4 percent of total
episodes. Likewise, the
[[Page 56458]]
episodes with 5, 6, or 7 visits each represent about 4.6 percent of
total episodes. We assume this same phenomenon will be observed in the
PDGM, except that, to account for the different threshold structure, it
will occur for periods that otherwise would be 1 or 2 visits away from
becoming non-LUPA.
We disagree with those commenters who state that the behavioral
assumptions basically construct a completely new payment system that is
predicated on gaming of the system. The goal of the proposed PDGM is to
more accurately pay for home health services based on patient
characteristics. As previously noted, section 1895(b)(3)(A)(iv) of the
Act requires that behavioral assumptions be made in calculating the
payment amount for CY 2020 so that the estimated aggregate amount of
expenditures under the HH PPS in CY 2020 is equal to the estimate
aggregate amount of expenditures in CY 2020 that otherwise would have
been made under the HH PPS if the change to a 30-day unit of payment
had not been enacted. Furthermore, we remind commenters that the law
requires that CMS analyze data for CYs 2020 through 2026, after
implementation of the 30-day unit of payment and the alternate case-mix
adjustment methodology, to annually determine the impact of the
differences between assumed and actual behavioral changes on estimated
aggregate expenditures and adjust the payment amount either upwards or
downwards accordingly. As such, we do not believe the law provides the
latitude to test behavioral assumptions prior to implementation of the
30-day unit of payment and the PDGM for CY 2020 given these
requirements, in law, to make behavioral assumptions in calculating a
30-day budget-neutral payment amount for CY 2020 and to determine the
impact on estimated aggregate expenditures of differences between the
assumed and actual behavior changes once the data for CYs 2020 through
2026 become available to determine whether temporary and permanent
adjustments are needed.
We believe that, as described in the CY 2019 HH PPS proposed rule
and throughout this final rule with comment period, we have provided
sufficient detail for these behavioral assumptions as well as
referenced past rules in which nominal case-mix change has been
evaluated. The reconciliation process involving temporary and permanent
adjustments required by law should assure HHAs that any over or
underestimate of the payment amount will be adjusted accordingly.
However, to support HHAs in evaluating the effects of the proposed
PDGM, CMS provides, upon request, a Home Health Claims-OASIS Limited
Data Set (LDS) to accompany the proposed and final rules. The Home
Health Claims-OASIS LDS file can be requested by following the
instructions on the following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA-NewLDS.html.
Comment: In its public comments to the proposed CY 2019 HH PPS
rule, MedPAC stated that the past experience of the home health PPS
demonstrates that HHAs have changed coding, utilization, and the mix of
services provided in reaction to new payment incentives. MedPAC
remarked that CMS continued to find nominal increases in case mix
unrelated to patient severity in later years and reduced payment by an
average of 1.8 percent a year in 2008 through 2017 to account for this
trend. MedPAC remarked that the proposed home health payment reduction
of 6.42 percent appears to be consistent with past coding trends but
that they do not expect that the reduction would create payment
adequacy issues for most HHAs. As MedPAC has noted previously, the
average margin of Medicare HHAs is 15.5%.
Response: We thank MedPAC for their comments and we agree that
there is sufficient evidence of HHA behavioral responses in reaction to
payment incentives. We believe that HHA margins are adequate and that
the 30-day budget-neutral payment amount should not cause revenue
concerns for the majority of HHAs.
Comment: Some commenters asked CMS to clarify their interpretation
of the BBA of 2018 as it relates to budget neutrality. Specifically,
Another commenter indicated that CMS should clarify that Congress
intended to replace the existing budget neutrality requirement under
the HH PPS with a temporary one-year budget neutrality requirement for
CY 2020 that would be limited to maintaining equal aggregate
expenditures associated with the transition between 60-day to 30-day
units of service.
Response: The law does not require CMS to replace the current
budget neutrality requirements as set forth in section 1895(b)(3)(A) of
the Act. However, 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 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. 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,
the home health applicable percentage increase, the adjustment for
case-mix changes, the adjustment if quality data is not reported, and
the productivity adjustment. However, this does not mean that the 30-
day budget-neutral payment amount only pertains to payments made in CY
2020 as we remind commenters that we are required to annually determine
the impact of differences between assumed and actual behavior changes
on estimated aggregate expenditures for CY 2020 through CY 2026 and
adjust the payment amount upwards or downwards accordingly. Because we
are proposing to implement the 30-day unit of payment and proposed PDGM
for CY 2020, we would propose the actual 30-day payment amount in the
CY 2020 HH PPS proposed rule calculated using CY 2018 home health
utilization data, and we would calculate this amount before application
of the proposed home health update percentage required for CY 2020 (as
required by section 1895(b)(3)(B)(ii)(V) of the Act).
Comment: Several commenters asked how CMS will make the
reconciliation between assumed and actual behavioral changes upon
implementation of the PDGM. A commenter indicated that CMS should fully
display the reconciliation process with public notice and an
opportunity to comment in advance of its application. Another commenter
wanted to know if CMS would update its behavioral assumptions using CY
2020 data to compare actual behavior to assumed behavior. Several
commenters were concerned that CMS was placing a cap on the growth in
home health services and in the event of growth, future payments would
be reduced to match a payment amount from a prior year. A few
commenters indicated that the behavioral assumptions are already
accounted for in the current PPS and stated that HHAs already are
incentivized to report the highest paying clinical diagnosis code on
the claim, and also to develop and deliver plans of care that exceed
the LUPA threshold.
Response: We provided a detailed explanation as to how we
calculated the 30-day budget-neutral payment amount in the CY 2019 HH
PPS proposed rule (83 FR 32389) Specifically, we described how we
calculated the budget-neutral 30-day payment amounts, both with and
without behavioral assumptions and using CY
[[Page 56459]]
2019 payment parameters (for example, proposed 2019 payment rates,
proposed 2019 case-mix weights, and outlier fixed-dollar loss ratio) to
determine the expenditures that would occur under the current case-mix
adjustment methodology. As with all elements of the PDGM, we would
update the impacts of the proposed behavioral assumptions using CY 2018
claims data in CY 2020 proposed rulemaking. This would be described in
the CY 2020 HH PPS proposed rule to ensure HHAs are fully aware of the
behavioral assumption impacts on the payment amount for CY 2020 using
the most recent data available for CY 2020 implementation.
In accordance with the BBA of 2018, we will annually determine the
impact of differences between assumed behavior changes and actual
behavior changes on estimated aggregate expenditures for CYs 2020
through 2026. 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.
In the CY 2015 HH PPS final rule (79 FR 66072), we finalized our
proposal to recalibrate the case-mix weights every year with more
current data. Therefore, we refer commenters to previous HH PPS rules
(for example, CY 2016 HH PPS final rule, (80 FR 68629)), where we
recalibrate case-mix weights to account for nominal case-mix change. We
anticipate a similar methodology when making any required permanent and
temporary adjustments to payments, as required under sections
1895(b)(3)(D)(ii) and (iii) of the Act, to address the impact of the
assumed versus actual behavioral change after implementation of the
PDGM and the 30-day budget-neutral payment amount. Section
1895(b)(3)(D)(ii) of the Act requires notice and comment rulemaking for
any permanent adjustments. Section 1895(b)(3)(D)(iii) of the Act
similarly requires notice and comment rulemaking for any temporary
adjustments. As a result, any reconciliation methodology for permanent
and/or temporary adjustments would be subject to rulemaking, with the
opportunity for the public to provide comments prior to the
finalization of any policies. The data from CYs 2020 through 2026 will
be available to determine whether temporary adjustments and/or
permanent adjustments (increase or decrease) are needed no earlier than
in years 2022 through 2028 rulemaking.
We believe that the temporary and prospective adjustments outlined
in the statute are not meant to act as a cap on overall home health
expenditures. CMS is required by section of 1895(b)(3)(A)(iv) of the
Act to calculate a 30-day payment amount for CY 2020 in a budget
neutral manner so that estimated aggregate expenditures under the HH
PPS during CY 2020 made under the new 30-day unit of payment would be
equal to the estimated aggregate expenditures that otherwise would have
been made in the absence of the 30-day unit of payment. Likewise, any
permanent or temporary adjustments made, as required by the BBA of
2018, would be made to address the impact of differences between
assumed and actual behavior changes on estimated aggregate expenditures
with respect to years beginning with 2020 and ending with 2026. Any
adjustment to the payment amount resulting from differences between
assumed versus actual behavior changes would not be related to
increases in the number of beneficiaries utilizing Medicare home health
services. The purpose of the required behavioral assumptions is to
calculate the 30-day budget-neutral payment amount and not to limit
payment for home health services or access to needed care.
We disagree with comments that state that the behavioral
assumptions made under the PDGM are already accounted for in the
current HH PPS case-mix system given the assumptions made under the
proposed PDGM are based on a shorter unit of payment, 30 days as
opposed to the current 60 days. As described throughout this final rule
with comment period and the proposed rule, the variation in resource
utilization is most notable in the first versus second and subsequent
30-day periods of care. Consequently, the behavioral assumptions are
based on the 30-day unit of payment and the unique case-mix variables
that are present under the PDGM, but not under the current HH PPS case-
mix system.
Comment: A few commenters remarked that it would be difficult to
change their behavior in response to the PDGM. For example, these
commenters referenced the LUPA thresholds that vary by case-mix group
and stated that these are difficult to understand and that it would be
extremely difficult for a front line care provider to know for a
specific patient whether they were close to a LUPA threshold.
Response: As we have described in detail in the CY 2019 HH PPS
proposed rule and other rules, the evidence supports a pattern of
``practicing to the payment''. Specifically, there is ample evidence
that there are notable behavior changes as they relate to payment
thresholds. The findings from the Report to Congress on the ``Medicare
Home Health Study: An Investigation on Access to Care and Payment for
Vulnerable Patient Populations'', note that concerns have been raised
about the use of therapy thresholds in the current HH PPS. Under the
current payment system, HHAs receive higher payments for providing more
therapy visits once certain thresholds are reached. As a result, the
average number of therapy visits per 60-day episode of care have
increased since the implementation of the HH PPS, while the number of
skilled nursing and home health aide visits have decreased over the
same time period as shown in Figure 3 of the CY 2018 HH PPS proposed
rule (82 FR 35276). The study demonstrates that the percentage of
episodes, and the average episode payment by the number of therapy
visits for episodes with at least one therapy visit in 2013 increased
sharply in therapy provision just over payment thresholds at 6, 7, and
16. Similarly, between 2008 and 2013, MedPAC reported a 26 percent
increase in the number of episodes with at least 6 therapy visits,
compared with a 1 percent increase in the number of episodes with five
or fewer therapy visits.\13\ CMS analysis demonstrates that the average
share of therapy visits across all 60-day episodes of care increased
from 9 percent of all visits in 1997, prior to the implementation of
the HH PPS (see 64 FR 58151), to 39 percent of all visits in 2015 (82
FR 35277). Furthermore, as noted in the FY 2001 HH PPS final rule, the
episode file showed that approximately 16 percent of episodes would
have received a LUPA (65 FR 41162). However, currently, only about 7
percent of all 60-day episodes receive a LUPA. In other words, it
appears HHAs changed practice patterns such that more than half of 60-
day episodes that would have been LUPAs upon implementation of the HH
PPS are now non-LUPAs.
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\13\ Medicare Payment Advisory Commission (MedPAC). ``Home
Health Care Services.'' Report to Congress: Medicare Payment Policy.
Washington, DC, March 2015. P. 223. Accessed on September 9, 2018 at
http://www.medpac.gov/docs/default-source/reports/chapter-9-home-health-care-services-march-2015-report-.pdf?sfvrsn=0.
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Therefore, past analysis confirms that there are noted changes in
provider behavior resulting from the presence of thresholds that affect
payment. As such, we believe that the presence of thresholds,
regardless of whether they are therapy or LUPA thresholds, provides the
incentive for providers to
[[Page 56460]]
adopt business practices that encourage the provision of visits to meet
and exceed these thresholds to receive higher payment.
Comment: A few commenters noted language in the FY 2019 Skilled
Nursing Facility Prospective Payment System (SNF PPS) Final Rule (83FR
39162), which included a payment and case-mix redesign known as the
Patient-Driven Payment Model (PDPM) and noted that CMS declined to make
any behavioral adjustments in the PDPM. These commenters stated that
because the PDPM did not implement behavioral adjustments then the PDGM
also should not implement behavioral adjustments.
Response: We remind commenters that section 1895(b)(3)(A)(iv) of
the Act requires CMS to make assumptions about behavior changes that
could occur as a result of the implementation of the 30-day unit of
payment and changes to the case-mix adjustment methodology when
calculating the 30-day budget-neutral payment amount for CY 2020.
Furthermore, as previously described in detail, we believe we have
ample experience and data regarding changes in provider behavior made
in response to payment changes that support the proposed behavioral
assumptions. Additionally, the law requires us to annually determine
the impact of differences between assumed and actual behavior changes
on estimated aggregate expenditures for CY 2020 through CY 2026 and
adjust the payment amount upwards or downwards accordingly. We will
analyze any actual, observed behavioral changes with respect to CYs
2020 through 2026 to make any payment adjustments beginning in CY 2022
at the earliest.
Comment: Some commenters indicated that the behavioral assumptions
were too high and out of line with case-mix adjustments made in recent
years. Commenters indicated that CMS should phase in reductions over
multiple years if they exceeded a certain amount (for example, 2
percent). Commenters indicated that adjustments should be based on
actual behavior change and not based on assumed behavioral change.
Several commenters recommended delaying implementation of the
behavioral assumptions until actual data on provider behavior is
available.
Response: As detailed throughout this final rule with comment
period, we believe there is sufficient evidence supporting the
behavioral assumptions and payment impacts. Therefore, we disagree that
the impacts of the assumptions are too high or not in alignment with
previous analysis of nominal case-mix growth. Likewise, MedPAC
commented that they believe the 6.42 percent reduction to the payment
amount from the behavioral assumptions was appropriate and does not
expect that this percent reduction would create payment adequacy issues
for most HHAs.
We acknowledge that there have been previous phase-ins of other
payment adjustments to account for nominal case mix growth. We remind
commenters that the statute requires that in calculating the 30-day
budget-neutral payment amount, for home health units of service
furnished that end during the 12-month period beginning January 1,
2020, the Secretary shall make assumptions about behavior changes that
could occur as a result of the implementation of a 30-day unit of
payment and the alternate case-mix adjustment methodology. Therefore,
we do not have the discretion to implement a different policy. However,
because the statute requires that we must 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, and to make payment amount
adjustments accordingly, we believe there is already a mechanism in
place to assure HHAs that payment amount will be adjusted to accurately
account for actual behavior.
We remind commenters that the 30-day unit of payment and the PDGM
will not be implemented until CY 2020 and CMS will analyze claims data
from CY 2018 to determine any changes to the payment amount for CY 2020
and will propose the amount in the CY 2020 HH PPS proposed rule.
Finally, we are required to make the adjustments at a later date when
we have actual data. Therefore, we can ensure that the 30-day payment
amounts are set at the level they would have been had changes in case
mix due to behavior adjustments been known. Therefore, we do not
believe it is necessary to phase-in the impacts of the behavioral
assumptions. By providing updated analysis and payment rates in the CY
2020 HH PPS proposed rule, this will allow stakeholders additional
opportunity to comment on the behavioral assumption impacts. While many
commenters wanted CMS to delay implementation of the behavioral
assumption impacts until actual data are available, CMS is required
under section 1895(b)(3)(A)(iv) of the Act to take into account
behavior changes that could occur as a result of the implementation of
a 30-day unit of payment and the case-mix adjustment factors that are
implemented in CY 2020 when calculating the 30-day budget neutral
payment amount for CY 2020. Deferring until actual data are available
would delay implementation of the behavioral assumption impacts until
CY 2022, which would not meet the requirements of the statute. Data
from CY 2020 to 2026 will be available to determine whether temporary
or permanent adjustments to the payment amounts are needed.
Comment: Several commenters encouraged CMS to closely monitor
utilization patterns, billing trends, and other associated behaviors
following implementation of the PDGM, to ensure that beneficiary access
is not negatively impacted as a result of the new case-mix system,
particularly the switch from a 60-day episode to a 30-day unit of
payment. There was also concern that agencies may inappropriately
extend 30-day periods that previously would have ended within 30 days
in order to receive additional payment. There were other commenters who
indicated that 30-day periods would cause beneficiaries to be
discharged from home health earlier than they otherwise would be. Some
commenters were concerned that certain visits would be frontloaded
under a 30-day system as opposed to being spread out over a longer
period of time, whereas another commenter indicated that have a 30-day
period would discourage frontloading.
Response: The goal of the PDGM is to more accurately align payment
with the cost of providing care and is not meant to penalize or harm
providers or beneficiaries. We recognize that changes in payment
generally have an effect on the provision of services and we believe we
have accounted for those assumed behavioral changes in calculating the
30-day budget-neutral payment amount. To address concerns regarding
patient access and safety, we remind commenters that the home health
CoPs are to help ensure the health and safety of Medicare
beneficiaries. The home health CoPs have requirements as they relate to
the content of the plan of care. Specifically, the CoPs at Sec. 484.60
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. Services must be furnished in accordance with accepted
standards of practice. Therefore, upon implementation of the PDGM, we
expect that HHAs will
[[Page 56461]]
continue to provide the services in accordance with the existing
requirements. As such, we would not expect HHAs to inappropriately
discharge home health patients or extend unnecessary home health
services.
CMS does not intend to prescribe how home health agencies provide
care to their patients. As reiterated throughout this section, services
provided, including the disciplines providing the care and the
frequency of those services, are done so in accordance with an
individualized plan of care, established and periodically reviewed by
the certifying physician. We recognize that some beneficiaries may
benefit from the frontloading of visits and there has been research to
indicate that the frontloading of skilled visits is beneficial to some
patients and may reduce hospitalization.\14\ However, there may be
other beneficiaries that may benefit from visits that are provided over
a longer period of time. In accordance with the plan of care
requirements at Sec. 484.60, we expect the provision of services to be
made to best meet the patient's care needs. After implementation of the
PDGM and a change to the 30-day unit of payment, CMS will closely
monitor utilization patterns, beneficiary impact and provider behavior
to see if any refinements to the PDGM are warranted, or if any concerns
are identified that may signal the need for appropriate program
integrity measures.
---------------------------------------------------------------------------
\14\ O'Connor M, Bowles KH, Feldman PH, St Pierre M,
Jarr[iacute]n O, Shah S, Murtaugh CM. Frontloading and intensity of
skilled home health visits: A state of the science. Home Health Care
Services Quarterly. 2014; 33(3):159-75. doi: 10.1080/
01621424.2014.931768.
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Comment: MedPAC recommended that CMS include an additional
behavioral assumption to account for responses to the shorter unit of
payment that would result in increased aggregate payments (that is,
HHAs changing visit patterns such that instead of having a single 30-
day period of care, they would provide just enough visits to get
payment for a second 30-day period of care).
Response: Public comments received in response to both the CY 2018
and CY 2019 HH PPS proposed rules presented conflicting predictions
regarding anticipated provider behavior in response to the timing
element of the PDGM with regards to 30-day periods of care. Several
commenters stated that they expected providers to discharge patients
after the first 30-days of care given that the case-mix weights are, on
average, higher for the first 30-days of care. Other commenters
expressed concern that providers may attempt to keep home health
beneficiaries on service for as long as possible. We do not believe is
it necessary to add any additional behavioral assumptions at this time
and we note that CMS is required to make future payment amount
adjustments based on the difference between assumed and actual
behavioral changes.
Comment: A couple of commenters raised the question of whether CMS
removed LUPA payments from the numerator when calculating the budget-
neutral 30-day payment amount with and without behavioral assumptions.
Response: CMS did not remove the LUPA payments from the numerator
when calculating the budget-neutral 30-day payment amounts. Including
LUPA payments provides a broader picture when looking at impacts. In
order to calculate the 30-day budget-neutral payment amount, both with
and without the behavioral assumptions, we first calculated the total,
aggregate amount of expenditures that would occur under the current
case-mix adjustment methodology. Because estimated aggregate
expenditures under the 30-day unit of payment must be budget neutral to
estimated aggregate expenditures made if the 30-day unit of payment was
not implemented, we must look at the aggregate payments made under the
current HH PPS. This means we must look at all payments made, including
LUPA payments.
Comment: Another commenter indicated that according to CMS' 2017
Fee-for-Service Supplemental Improper Payment Data report, the
projected amount of improper payments made to HHAs for incorrect coding
was $0 and that this zero dollar figure stands in stark contrast to
CMS' assumption that all HHAs will use improper codes to bill Medicare
for higher payments under PDGM. Conversely, other commenters indicated
that the behavioral assumptions will cause a perverse incentive to
``upcode'' when previously agencies wouldn't have engaged in this
practice.
Response: 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.
Specifically, ``improper payments'' include: Both overpayments and
underpayments; payments to an ineligible recipient; payments for an
ineligible service duplicate payments; payments for services not
received; or, payments for an incorrect amount. Conversely, as we have
noted throughout this section, the purpose of the behavioral
assumptions is to take into account assumed behavioral changes
resulting from a change in the unit of payment from 60 to 30 days and
the change to the case-mix adjustment methodology in order to calculate
a 30-day budget neutral prospective payment amount, and not to
determine whether improper payments were or will be made. We have also
stated that the purpose of the behavioral assumptions is not to be
punitive or to indicate that HHAs are engaging in unethical or
inappropriate behavior, but to anticipate those behavioral changes when
calculating a prospective payment. We expect coding changes to occur
given the expansion of the ICD-10 code set and the PDGM using the
diagnoses reported on the claim as opposed to the OASIS. This provides
HHAs with an opportunity to report conditions supported in the medical
documentation for which home health services are being provided. We
remind commenters that ``upcoding'' is a fraudulent billing practice
where a healthcare provider assigns an inaccurate billing code to a
medical procedure or treatment to increase payment and where the actual
service(s) provided are not supported by the codes reported. We do not
view reporting diagnoses that are supported in the medical
documentation and which reflect the home health care and services
provided to be ``upcoding''. We do expect, however, that HHAs will
establish the individualized plan of care in accordance with the needs
identified in the initial and comprehensive assessments to address all
pertinent and supported diagnoses.
Final Decision: We are finalizing the three behavioral assumptions
as previously described in calculating a 30-day budget-neutral payment
amount. We will update the CY 2020 30-day budget-neutral payment amount
in the CY 2020 proposed rule using the most recent data available.
c. Split Percentage Payment Approach for a 30-Day Unit of Payment
In the current HH PPS, there is a split percentage payment approach
to the 60-day episode. 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 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.
[[Page 56462]]
The BBA of 2018 requires a change to the unit of payment from a 60-
day episode to a 30-day period of care, effective January 1, 2020. As
described in the CY 2018 HH PPS proposed rule (82 FR 35270) and in the
CY 2019 HH PPS proposed rule (83 FR 32391), we believe that as a result
of the reduced timeframe for the unit of payment, that a split
percentage approach to payment may not be needed for HHAs to maintain
adequate cash flow. Currently, about 5 percent of requests for
anticipated payment are not submitted until the end of a 60-day episode
of care and the median length of days for RAP submission is 12 days
from the start of the 60-day episode. As such, we are reevaluating the
necessity of RAPs for existing and newly-certified HHAs versus the
risks they pose to the Medicare program.
In the CY 2019 HH PPS proposed rule, we described in detail,
potential program integrity vulnerabilities as they relate to RAP
payments (83 FR 32391). We stated that given the program integrity
concerns and the reduced timeframe for the unit of payment (30 days
rather than 60 days), we proposed not to allow newly-enrolled HHAs,
that is HHAs certified for participation in Medicare effective on or
after January 1, 2019, to receive RAP payments beginning in CY 2020. We
proposed that HHAs, that are certified for participation in Medicare
effective on or after January 1, 2019, would still be required to
submit a ``no pay'' RAP at the beginning of care in order to establish
the home health period of care, as well as every 30-days thereafter.
We proposed that existing HHAs, that is HHAs certified for
participation in Medicare with effective dates prior to January 1,
2019, would continue to receive RAP payments upon implementation of the
30-day unit of payment and the proposed PDGM case-mix adjustment
methodology in CY 2020.
We solicited comments as to whether the split payment approach
would still be needed for HHAs to maintain adequate cash flow if the
unit of payment changes from 60-day episodes to 30-day periods of care
under our proposal. In addition, we solicited comments on ways to
phase-out the split percentage payment approach in the future.
Specifically, we solicited comments on reducing the percentage of the
upfront payment over a period of time. We also solicited comments on
requiring for HHAs to submit a notice of admission within 5 days of the
start of care to alert the claims processing system that a beneficiary
is under a home health period of care, if in the future the split
percentage approach was eliminated. to assure being established as the
primary HHA for the beneficiary and so that the claims processing
system is alerted that a beneficiary is under a HH period of care to
enforce the consolidating billing edits required by law.
The following is a summary of the public comments received on the
``Split Percentage Payment Approach for a 30-day Unit of Payment''
proposal and our responses:
Comment: Many commenters supported all or parts of CMS's changes to
the RAP policy. Some commenters indicated that the elimination of the
split percentage would align better with a 30-day payment and would
simplify claims submission. Other commenters stated they do not want
any type of phase-out of RAPs and remarked that RAPs should continue
under the PDGM to ensure no disruption in cash flow. There was 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 to adapt to PDGM. Some
commenters indicated that RAPs for late periods could be phased out,
but that RAPs for early periods should remain in place to ensure an
upfront payment for newly admitted home health patients. Some
commenters supported the reduction in the split percentage payment but
wanted to allow RAPs for newly enrolled HHAs.
Response: We thank commenters for their careful review and
suggestions regarding the proposals regarding a potential phase-out of
RAPs. We continue to believe that as a result of a reduced timeframe
for the unit of payment from a 60-day episode to a 30-day period, that
a split percentage approach to payment may not be needed for HHAs to
maintain an adequate cash flow. We also believe that by eventually
phasing-out the submission of RAPs with each 30-day period, that this
will significantly streamline claims processing for HHAs. Likewise, by
eliminating RAP payments for newly-enrolled HHAs, we believe this would
allow these HHAs to structure their operations without becoming
dependent on a partial advanced payment and take advantage of receiving
full payments every 30 days. We will continue to monitor the need for
RAPs after the implementation of the PDGM. We understand that HHAs may
need time to adapt to the PDGM so any phase-out of RAP payments for
existing HHAs would be addressed in future rulemaking.
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. Some commenters
indicated that not all cases where a final claim isn't submitted after
a RAP are abusive. Commenters encouraged CMS to identify the agencies
that are abusing the system and to impose more oversight through
accrediting organizations and the MACs.
Response: While one of the reasons for the elimination of the RAP
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. With a change to a 30-day unit of payment, 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.
We acknowledge and appreciate the concerns commenters have 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 in case any cases of provider abuse are
identified.
We would like to reiterate that in the CY 2019 HH PPS proposed
rule, we proposed existing HHAs, that is HHAs that are certified for
participation in Medicare with effective dates prior to January 1,
2019, would continue to receive RAP payments upon implementation of the
PDGM in CY 2020. Only newly-enrolled HHAs, that is HHAs certified for
participation in Medicare effective on or after January 1, 2019, would
not receive RAP payments beginning in CY 2020.
Comment: Several commenters believe that newly enrolled HHAs have
the same or more cash flow concerns as
[[Page 56463]]
existing HHAs and that split-percentage payments should also be made to
newly enrolled HHAs. Some commenters expressed concern about HHAs
acquired or opened on or after January 1, 2019 under a HHA chain
organization and whether these newly enrolled HHAs that are part of a
chain would be ``grandfathered'' in and would be allowed to receive RAP
payments beginning in CY 2020. These commenters remarked that not
allowing these HHAs to be grandfathered in would disrupt operations.
Response: While we appreciate commenter concerns, in the CY 2019 HH
PPS proposed rule, when referring to not allowing newly-enrolled HHAs
(that is, those certified for Medicare participation effective on or
after January 1, 2019) to receive RAP payments beginning in CY 2020, we
did not distinguish between solely-owned HHAs and HHAs that are owned
by a parent or chain company. For payment purposes, a CMS Certification
Number (CCN) is required to be included on the Medicare claim and the
RAP. Upon Medicare enrollment, a CCN is issued. This policy is
applicable to newly enrolled HHAs and thus this policy would apply to
those HHAs with a CCN that is effective on and after January 1, 2019,
regardless of whether they are solely-owned or owned by a patent or
chain company. We believe that having the opportunity to receive full
payment every 30 days may mitigate cash flow concerns for newly
enrolled HHAs.
Comment: Some commenters expressed support for the Notice of
Admission (NOA) and recognized that the NOA would be necessary to alert
the claims processing system of a home health period of care because of
the consolidated bulling requirements. Other commenters opposed the use
of a NOA and the requirement to submit a NOA within 5 days of the home
health start of care. These commenters referenced some of the
operational and processing issues with the hospice Notice of Election
and expressed concern that there could be delay in needed care. Other
questioned the burden associated with a NOA process.
Response: We remind commenters that existing HHAs, meaning those
certified for participation in Medicare with effective dates prior to
January 1, 2019, would continue with the same RAP submission process as
they currently follow under the current HH PPS except that a RAP would
have to be submitted at the beginning of each 30-day period of care.
Likewise, we proposed that newly-enrolled HHAs (that is, those
certified for participation in Medicare effective on and after January
1, 2019) would have to submit a ``no-pay'' RAP at the beginning of care
in order to establish the home health period of care, as well as every
30-days thereafter. RAP submissions are significant as the RAP
establishes the HHA as the primary HHA for the beneficiary during the
timeframe and alerts the claims processing system that the beneficiary
is under the care of the HHA. A Notice of Admission (NOA) would only be
required if the split-percentage payment approach is eliminated in the
future. However, we did not propose to eliminate RAP payments for
existing providers and newly-enrolled providers would only have to
submit a ``no-pay'' RAP in order to establish a home health period of
care within the claims processing system. If we do propose elimination
of the split-percentage approach, we would do so in future rulemaking
and would solicit comments at that time about the process that would be
established in regards to the submission of a Notice of Admission.
Final Decision: We are finalizing the split-percentage proposal as
proposed with an effective date of January 1, 2020. This means that
newly-enrolled HHAs, that is HHAs certified for participation in
Medicare effective on or after January 1, 2019, would not receive RAP
payments beginning in CY 2020. HHAs that are certified for
participation in Medicare effective on or after January 1, 2019, would
still be required to submit a ``no pay'' RAP at the beginning 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 effective prior to January 1,
2019, will continue to receive RAP payments upon implementation of the
PDGM in CY 2020. For split-percentage payments to be made, existing
HHAs would have to submit a RAP at the beginning of each 30-day period
of care and a final claim would be submitted at the end of each 30-day
period of care. For the first 30-day period of care, the split
percentage payment would be 60/40 and all subsequent 30-day periods of
care would be a split percentage payment of 50/50. We are also
finalizing the corresponding regulations text changes as described in
section III.F.13 of this final rule with comment period related to the
split percentage payment approach.
4. Timing Categories
In the CY 2019 HH PPS proposed rule, we described analysis showing
the impact of timing on home health resource use and proposed to
classify the 30-day periods under the proposed PDGM as ``early'' or
``late'' depending on when they occur within a sequence of 30-day
periods. For the purposes of defining ``early'' and ``late'' periods
for the PDGM, we proposed that only the first 30-day period in a
sequence of periods be defined as ``early'' and all other subsequent
30-day periods would be considered ``late''. Additionally, we proposed
that the definition of a ``home health sequence'' (as currently
described in Sec. 484.230) would remain unchanged relative to the
current system; that is, 30-day periods are considered to be in the
same sequence as long as no more than 60 days pass between the end of
one period and the start of the next, which is consistent with the
definition of a ``home health spell of illness'' described at section
1861(tt)(2) of the Act. We further noted that because section
1861(tt)(2) of the Act is a definition related to eligibility for home
health services as described at section 1812(a)(3) of the Act, it does
not affect or restrict our ability to implement a 30-day unit of
payment.
We solicited public comments on the timing categories under the
proposed PDGM and the associated regulations text changes discussed in
section III.F.13 of the proposed rule. The following is a summary of
the public comments received and our responses:
Comment: Several commenters supported the inclusion of the timing
category in the PDGM, stating that this differentiation reflects that
HHA costs are typically highest during the first 30 days of care and
supports HHA efforts to follow clinical evidence on the importance of
``frontloading'' resources in the home care setting in order to
facilitate improved patient outcomes.
Response: We appreciate the commenters' support regarding the
inclusion of the timing element within the PDGM framework, as we
believe that the early and late designations will serve to better align
payments with the existing resource use pattern observed in home health
data. The utilization of increased resources in early periods is
demonstrated in the data analyzed during the development of the PDGM,
as described in the CY 2019 HH PPS proposed rule (83 FR 32340). We
believe that ultimately this component of the PDGM will help to account
for the increase in intensity of resources often required at the start
of home health care.
Comment: Several commenters expressed concern regarding the change
in the definition of ``early'' and ``late'' 30-day periods from the
current payment model, stating that many patients need more than 30
days of intense care due to their medically
[[Page 56464]]
complex, chronic conditions and their multiple, serious diagnoses
requiring skilled assessment and interventions. The commenters asserted
that HHAs may ration care to those beneficiaries in ``late'' 30-day
periods and that the new timing category would serve to penalize those
HHAs that do enroll clinically-complex beneficiaries with ongoing care
needs. Several commenters stated that categorizing 30-day home health
periods into ``early'' and ``late'' would serve to ``devalue'' later
care during a home health period of care. A commenter also stated that
categorizing only the first 30 days as ``early'' would potentially put
beneficiaries at risk because they state that more costly therapy
services become most appropriate as a beneficiary begins to stabilize,
which the commenter stated typically occurs around week three of a home
health care. Another commenter also stated that caregiver availability
also varies in the weeks following an acute event, with support
diminishing in the weeks following admission to home health, leading to
an increased need for additional support during those 30-day periods
that would now be categorized as ``late.'' Several commenters expressed
concern that the definition of the ``late'' category would not account
for any additional costs that would be associated with a new set of
resource-intensive health needs for a patient that may occur after the
``early'' 30-day period.
Response: As described in detail in the CY 2019 HH PPS proposed
rule, our proposal regarding the timing element of the PDGM was
intended to refine and to better fit costs incurred by agencies for
patients with differing characteristics and needs under the HH PPS (83
FR 32340). The resource cost estimates are derived from a very large,
representative dataset. Therefore, we expect that the proposal reflects
agencies' average costs for all home health beneficiaries, including
medically-complex patients with ongoing needs. We have constructed the
revised payment model based upon the actual resources expended by home
health agencies for Medicare beneficiaries, which show that typically
HHAs provide more visits during the first 30 days of care and utilize
less resources thereafter. We reiterate that the timing categories are
reflective of the utilization patterns observed in the data analyzed
for the purposes of constructing the PDGM, and we have not manipulated
the resource utilization or weighting to encourage certain patterns of
care for the first 30-day period within the PDGM. The weights of the
two timing categories are driven by the mix of services provided, the
costs of services provided as determined by cost report data, the
length of the visits, and the number of visits provided. The
categorization of 30-day periods as ``early'' and ``late'' serves to
better align payments with already existing resource use patterns. This
alignment of payment with resource use is not to be interpreted as
placing a value judgment on particular care patterns or patient
populations.
Additionally, in our CY 2008 HH PPS final rule, we implemented an
``early'' and ``late'' distinction in the HH PPS in which the late
episode groupings were weighted more heavily than those episodes
designated as early due to heavier resource use during later episodes
(72 FR 49770). At that time, commenters expressed concerns that this
heavier weighting for later episodes could lead to gaming by providers,
with patients on service longer than would be appropriate, and that
providers may not discharge patients when merited. During our analysis
in support of subsequent refinements to the HH PPS in 2015, as
described in the CY 2015 HH PPS proposed rule (79 FR 38366), we
analyzed the utilization patterns observed in the CY 2013 claims data
and observed that the resource use for later episodes had indeed
shifted such that later episodes had less resource use than earlier
periods, which was the opposite of the pattern observed prior to CY
2008. Furthermore, in its 2016 Report to Congress, MedPAC noted that,
between 2002 and 2014, a pattern in home health emerged where the
number of episodes of care provided to home health beneficiaries
trended upwards, with the average number of episodes per user
increasing by 18 percent, rising from 1.6 to 1.9 episodes per user.\15\
MedPAC noted that this upward trajectory coincided with, among other
changes, higher payments for the third and later episodes in a
consecutive spell of home health episodes. Given the longitudinal
variation in terms of resource use during home health episodes, we
believe that restricting the ``early'' definition to the first 30-day
is most appropriate for this facet of the PDGM. Our analysis of home
health resource use, our review of the literature on ``frontloading,''
as well as comments from the public that confirm that more resources
are used in the first 30 days, provide compelling evidence to limit the
definition of early to the first 30-day period. As we receive and
evaluate new data related to utilization patterns in Medicare home
health care, specifically under the PDGM, we will reassess the
appropriateness of the payment levels for ``early'' and ``late''
periods in a sequence of periods, and we will evaluate whether changes
are needed once the model has been implemented.
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\15\ http://www.medpac.gov/docs/default-source/reports/chapter-8-home-health-care-services-march-2016-report-.pdf.
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Comment: Several commenters described concerns regarding the
potential for problematic provider behavior due to financial
incentives. Several commenters stated that the timing element of the
PDGM has the potential to create an incentive to increase overall
patient volume, to discourage providers from accepting community
referrals, to extend home health lengths of stay so as to include at
least two 30-day periods, and to promote lower quality home health care
in order to maximize reimbursements. Several commenters stated that the
timing variable in the PDGM payment model would increase the incentive
to prematurely discharge patients while other commenters stated that
the timing variable may incentivize HHAs to avoid patients who require
care over the span of multiple periods of care.
Response: 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 ``early'' and ``late''
periods in a sequence of periods. Additionally, we will share any
concerning behavior or patterns with the MACs and/or other program
integrity contractors. We plan to monitor for 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 note that an increase in the volume of Medicare
beneficiaries receiving home health care may, in fact, represent a
positive outcome of the PDGM, signaling increased access to care for
the Medicare population, so long as said increase in volume of
beneficiaries is in keeping with eligibility guidelines for the
Medicare home health benefit.
Moreover, the public comments we received in response to both the
CY 2018 and CY 2019 HH PPS proposed rules presented conflicting
predictions regarding anticipated provider behavior in response to the
implementation of the PDGM. Several commenters stated that they
expected providers to discharge patients after the first 30-days of
care given that the case-mix weights are, on average, higher for the
first 30-days of care. Other commenters expressed
[[Page 56465]]
concern that providers may attempt to keep home health beneficiaries on
service for as long as possible. We note the PDGM case-mix weights
reflect existing patterns of resource use observed in our analyses of
home health claims data. Since we proposed to recalibrate the PDGM
case-mix weights on an annual basis to ensure that the case-mix weights
reflect the most recent utilization data available at the time of
rulemaking, future recalibrations of the PDGM case-mix weights may
result in changes to the case-mix weights for early versus late 30-day
periods of care as a result of changes in utilization patterns.
Finally, we expect that HHAs will furnish care in accordance with each
beneficiary's HH plan of care as required by the HH CoPs at Sec.
484.60.
Comment: Several commenters requested that we modify the definition
of an ``early'' 30-day period to either the first two 30-day periods or
the first four 30-days of care, stating that those definitions would
more closely mirror the current payment system's definition of
``early'' and that HHAs would otherwise experience a payment decrease
when compared to the current 60-day episode payment amount because of
the differentiated payment amounts for ``early'' and ``late'' 30-day
periods. The commenters also stated that there is concern that the PDGM
definitions of ``early'' and ``late'' may hurt agencies due to the
decrease in overall payment because of the lower reimbursement for
periods categorized as ``late.'' Another commenter stated that the PDGM
inaccurately ties payment to time in home health care, with very little
regard to actual care needs.
Response: With regard to a potential reduction in overall payment
due to the revised designations of ``early'' and ``late'' periods under
the PDGM, as we described in the CY 2019 HH PPS proposed rule, our
analysis of the related data indicates that there is significant
difference in the resource utilization between early and late 30-day
periods as demonstrated in Table 34 of the proposed rule (83 FR 32392).
One of the driving goals in the development of the PDGM was to better
align payments with costs incurred by agencies for patients with
differing characteristics and needs under the HH PPS. We continue to
believe that a PDGM that accounts for the actual, demonstrated increase
in resource utilization in the first 30-day period better captures the
variations in resource utilization. We believe that the PDGM further
promotes the goal of payment accuracy within the HH PPS and Medicare
overall. However, we note that we will continue to monitor for any
changes in trends as evidenced by home health data reflecting the
change to the HH PPS and make modifications to the PDGM as necessary.
Comment: Several commenters suggested that we revise the payment
model such that a readmission to home health within the 60-day gap
period results in an ``early'' instead of a ``late'' 30-day period.
They suggested that we should consider altering the definition of
sequences of 30-day periods to include home health re-admissions
following acute institutionalization as a condition of determining a
new sequence of home health periods of care, in addition to the 60-day
gap in home health services, stating that this would be akin to the
proposal defining admission source for the purposes of determining
institutional payment status.
Response: We appreciate the commenter's suggestion regarding the
consideration of a readmission to home health within the 60-day gap be
treated as an ``early'' stay. However, we note that the PDGM also
includes a category for source of admission, which would account for a
readmission to home health within 14 days of an acute care hospital
stay. The admission source category is discussed in detail in Section
III.E.5 of this final rule with comment period. Under the PDGM we
already account for the differentiating features of institutional
stays, including inpatient stays that occur within 14 days of the
commencement of a home health period. Our proposal was intended to
refine and to better fit costs incurred by agencies for patients with
differing characteristics and needs under the prospective payment
system. Therefore, we expect that the addition of both the source of
admission as well as the timing categories would reflect agencies'
average costs for home health patients. We believe that crafting a
multi-pronged model, which includes adjustments based both on timing
within a home health sequence as well as the source of the
beneficiary's admission, will serve to more accurately account for
resources required for Medicare beneficiaries and similarly provide a
differentiated payment amount for care.
Comment: A commenter stated that the timing categories create
disincentives for home health care providers to prevent hospital
readmissions because a resumption of care would then generate higher
revenues. Another commenter stated that HHAs often front load visits
post hospitalization or admission to a SNF, including the ``resumption
of care period.'' The commenter expressed concern that the proposed
timing categories for the PDGM do not capture the resources required
for a resumption of care and asks that we expand the definition of
sequencing of ``early'' periods to include home health readmissions
following acute hospital or SNF stays.
Response: For the purposes of the timing category of the PDGM, an
intervening hospital stay would not trigger re-categorization to an
``early'' 30-day period of care unless there was more than a 60-day gap
in home health care. Therefore, we do not believe that the timing
element of the PDGM would create a financial incentive to
inappropriately encourage the admission of home health patients to an
acute care setting in order to receive a subsequent home health
referral in the higher-paid ``early'' category. Additionally, we note
that the admission source category within the PDGM serves to capture
the increased resource needs in the home health population referred
from an inpatient hospital stay, occurring within 14 days of home
health admission, creating differentiated case-mix weights that align
payment with the resource use for that subpopulation of home health
beneficiaries.
Comment: Several commenters expressed concern regarding the
operational aspects of the timing element of the PDGM. Another
commenter asked how patient transfers would be addressed, asserting
that the second agency should not receive lower payment if they were
unaware that the patient was being served by another home health
agency. A commenter expressed concern regarding the identification of
the timing of the 30-day period, stating that the OASIS in particular
does not provide enough information to determine timing for a 30-day
period.
Response: As we described in the CY 2019 HH PPS proposed rule, we
will use Medicare claims data and not the OASIS assessment in order to
determine if a 30-day period is considered ``early'' or ``late'' (83 FR
32393). Regarding transfers, we note that 30-day periods are considered
to be adjacent if they are contiguous, meaning they are separated by no
more than a 60-day period between 30-day periods of care. This would
mean that if a patient transfers from one HHA to another HHA after the
first 30-day period of care, all adjacent 30-day periods of care would
be considered ``late''. In order for any 30-day period of care to be
considered ``early'', there would have to be a gap in home health
services of more than 60
[[Page 56466]]
days. We have developed claims processing procedures to reduce the
amount of administrative burden associated with the implementation of
the PDGM. Providers will not have to determine whether a 30-day period
is early (the first 30-day period) or later (all adjacent 30-day
periods beyond the first 30-day period) if they choose not to.
Information from Medicare systems will be used during claims processing
to automatically assign the appropriate timing category. Details
regarding these processes are outlined in the CY 2019 HH PPS proposed
rule (83 FR 32394). We reiterate that we plan to develop materials
regarding the timing categories, including such topics as claims
adjustments and resolution of claims processing issues. We will also
update guidance in the Medicare Claims Processing Manual as well as the
Medicare Benefit Manual as appropriate with detailed procedures. We
will also work with the MACs to address any concerns regarding the
processing of home health claims as well as develop training materials
to facilitate all aspects of the transition from the current payment
system to the PDGM, including the unique aspects of the timing
categories.
Final Decision: We are finalizing our proposal to classify 30-day
periods of care under the PDGM as ``early'' or ``late'' depending on
when they occur within a sequence of 30-day periods. The first 30-day
period would be classified as early and all subsequent 30-day periods
in the sequence (second or later) would be classified as late and 30-
day periods of care cannot be considered early unless there is a gap of
more than 60 days between the end of one period and the start of
another.
5. Admission Source Categories
In the CY 2019 HH PPS proposed rule, we described analysis showing
the impact of the source of admission on home health resource use and
proposed to establish two admission source categories for grouping 30-
day periods of care under the PDGM--institutional and community--as
determined by the healthcare setting utilized in the 14 days prior to
home health admission (83 FR 32340). We proposed that 30-day periods
for beneficiaries with any inpatient acute care hospitalizations,
skilled nursing facility (SNF) stays, inpatient rehabilitation facility
(IRF) stays, or long term care hospital (LTCH) stays within the 14 days
prior to a home health admission would be designated as institutional
admissions. We also proposed that the institutional admission source
category would 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 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 also proposed
that we would not categorize PAC stays (SNF, IRF, LTCH stays) that
occur during a previous 30-day period and within 14 days of a
subsequent, contiguous 30-day period of care (that is, the admission
date and from date for the subsequent 30-day period of care do not
match) as institutional, as we would expect the HHA to discharge the
patient if the patient required PAC in a different setting and then
readmitted the patient, if necessary, after discharge from such
setting. If the patient was discharged and then readmitted to home
health, the admission date and ``from'' date on the 30-day claim would
match and the claims processing system will look for an acute or a PAC
stay within 14 days of the home health admission date. We proposed that
this admission source designation process would be applicable to
institutional stays both paid by Medicare or another payer. All other
30-day periods would be designated as community admissions. For the
purposes of a RAP, we proposed that we would only adjust the final home
health claim submitted for source of admission. Additionally, we also
proposed that HHAs would only indicate the proposed admission source
occurrence codes on the final claim and not on any RAPs submitted. The
proposed admission source category was discussed in detail in the
proposed rule.
We solicited public comments on the admission source component of
the proposed PDGM. The following is a summary of the public comments
and our responses:
Comment: Several commenters expressed their support for the
admission categories within the framework of the PDGM, as they believe
patient needs significantly differ between these groups and payment
differences are warranted in order to better reflect the cost of
Medicare home health care, thus improving the accuracy of payments in
the revised system.
Response: We appreciate the commenters' support with regard to the
admission source element of the PDGM. The intention of the PDGM
proposal, including the admission source component, is to refine and to
better fit costs incurred by agencies for patients with differing
characteristics and needs under the prospective payment system, and we
believe that the differing weights for source of admission will
facilitate more appropriate alignment within the HH PPS.
Comment: Several commenters stated that the source of a home health
admission may not always correspond with home health beneficiary needs
and corresponding provider costs, as some community entrants sometimes
require more intensive resources than their institutional counterparts,
presenting with complex conditions such as psychiatric and neurological
conditions, pressure and stasis ulcers, and a history of falls. Several
commenters also stated that we are ``devaluing'' community entrants by
providing lower reimbursement for those beneficiaries when compared
with institutional entrants.
Response: As described in detail in the CY 2019 HH PPS proposed
rule, our analytic findings demonstrate that institutional admissions
have 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 PDGM (83 FR 32340). We do
not seek to ``devalue'' or show preference to any particular patient
profile, but rather aim to better align home health payment with the
costs observed in providing care. Additionally, as discussed in our CY
2019 HH PPS proposed rule, current research around those patients who
are discharged from acute and PAC settings shows that these
beneficiaries tend to be sicker upon admission, are being discharged
rapidly back to the community, and are more likely to be re-
hospitalized after discharge due to the acute nature of their illness
(83 FR 32396). As further described in the CY 2019 HH PPS proposed
rule, research studies indicate that patients admitted to home health
from institutional settings are vulnerable to adverse effects and
injury because of the functional decline that occurs due to their
institutional stay, indicating that the patient population referred
from an institutional setting requires more concentrated resources and
supports to account for and mitigate this functional decline (83 FR
32397). We continue to believe that accounting for the material
differences in the care needs of the home health beneficiary population
admitted from institutional settings and their resulting,
differentiated resource use, will serve to better align payments
[[Page 56467]]
with actual costs incurred by HHAs when providing care. We will
carefully monitor the outcomes of this change, including any impacts to
community entrants, and make further refinements as necessary. We also
note that a component of the PDGM is the classification of periods of
care into clinical groups according to the principal diagnosis
reported. This component of the PDGM serves to capture the different
resource needs of different conditions in the home health population,
including complex conditions such as neurological conditions.
Comment: Several commenters noted that the admission source
component of the PDGM has strong explanatory power in the model,
outweighing clinical and functional factors. Several commenters believe
the inclusion of admission source in the PDGM is akin to the use of
therapy thresholds in HHRGs, as the commenters assert that it has the
potential to create inappropriate incentives. Some commenters suggested
that admission source not be utilized used in the model; instead, only
patient clinical and functional status should be considered. Other
commenters believe that the payment differences by admission source is
too great. A commenter recommended that additional analysis be
conducted regarding the payment adjustment for admission source and
that we determine if other elements of the case-mix system would more
adequately account for differences in payments when compared to the
admission source variable. Another commenter stated that the admission
source component of the PDGM is inaccurate and will likely push
patients into the institutional setting and suggested that we instead
utilize a ``risk of readmission'' measure, which could serve to gauge
patient severity and promote value-based care.
Response: We appreciate the commenters' feedback regarding the
admission source component of the PDGM. However, we reiterate that the
analytic findings presented in the CY 2019 HH PPS proposed rule point
to clear differences in resources utilized by beneficiaries with
differing sources of admission. In developing the various elements of
the PDGM, we sought to focus on variables that predicted care needed by
the patient (83 FR 32340). We disagree that using an admission source
variable is equivalent to therapy thresholds. The data supports that
resource utilization is higher among those with beneficiaries who have
had a previous institutional stay prior to admission to home health,
which accounts for the explanatory power of this particular variable.
Conversely, increased payment associated with the therapy thresholds is
directly correlated with the number of therapy visits provided.
Regarding the suggestion that we instead utilize a ``risk of
readmission'' measure, we remind commenters that the PDGM does include
an OASIS item for ``Risk for Hospitalization'' in its construction at
the functional level to further account for patient characteristics
that could translate into resource use. We note that we will continue
to analyze the inclusion of other variables in the PDGM case-mix
adjustment and will consider such additional components for future
refinement.
Comment: Commenters stated that inpatient settings would become the
primary patient referral target for HHAs and that community referral
beneficiaries may find HHAs less willing to admit them to home health
care if CMS were to finalize the admission source categories in the
PDGM as proposed.
Response: We appreciate the commenters' concern regarding possible
behavioral changes by providers given the perceived incentives created
by the admission source categories within the PDGM. We continue to
expect that HHAs will provide the appropriate care needed by all
beneficiaries who are eligible for the home health benefit, including
those beneficiaries with medically-complex conditions who are admitted
from the community. We recognize that providers may shift practices
based upon strategies meant to maximize payment; therefore, we plan to
closely monitor for any concerning trends in provider behavior,
including such metrics as proportion of cases in a provider's caseload
referred from both the community and institutional settings. We also
note that in previous analysis related to the solicitation of home
health referrals, research has shown that many agencies seek referrals
from any setting, institutional or otherwise. In the FY 2001 HH PPS
proposed rule, evaluators assessing the HH PPS demonstration came to
the conclusion that agencies did not alter their behavior in response
to payment changes in the home health demonstration in such a way that
impacted beneficiary access or quality of care, nor did they employ
practices in order to avoid costly patients or recruit lower-care cases
(64 FR 58140). Many agencies wanted to maintain a steady stream of
referrals and were therefore not in a position to avoid a specific
referral source, and, as a result, did not do so. We expect that HH
providers will continue to seek referrals from all sources under the
PDGM system, resulting in continued access to home health care for
Medicare beneficiaries.
Comment: Several commenters suggested the inclusion of inpatient
psychiatric facility (IPF) stays in the institutional category for the
purposes of the PDGM.
Response: We appreciate the commenters' feedback and agree that
inpatient psychiatric facility (IPF) stays should be included in the
institutional category for the payment system under the PDGM. We agree
that admission to an inpatient psychiatric facility would merit
inclusion as an institutional source under the PDGM and therefore, we
will include this site of service as part of the institutional category
case-mix variable.
Comment: Several commenters recommended that CMS consider
incorporating other clinical settings into the definition of the
institutional category, including hospices and outpatient facilities,
including emergency rooms. The commenters asserted that the criteria
for inpatient hospital admission versus outpatient and other non-acute/
PAC services are not always clear and that the differences between
patients admitted as inpatient versus as outpatient are minimal. The
commenters also stated that observation stays, which are not considered
institutional stays by CMS, should be considered as such for the
purposes of the PDGM, in part because beneficiaries and their families
will have the ``perception'' of an inpatient stay and inform the HHA of
what they perceive to have been an institutional stay. Another
commenter stated that patients who utilize emergency room services
either need a higher level of home health services once they transition
to home health care or they require a lot of education to encourage
them to utilize options other than the ER when issues arise. The
commenter moreover asserted that hospitals have become adept at using
observation stays for purposes of avoiding re-hospitalization penalties
but maintains that these patients have just as high acuity as those
referred to home health from a typical inpatient hospital stay. A
commenter stated that joint replacement surgery continues to evolve,
and patients are having surgery and are being treated as an
``observation stay'' rather than a hospital admission despite requiring
a high level of service once they return home. A commenter noted
concern that categorization could limit access to home care for joint
replacements that may occur in ambulatory surgery centers and other
outpatient facilities,
[[Page 56468]]
settings not currently considered institutional for the purposes of the
PDGM. Another commenter stated that the exclusion of observation stays
and ED visits from the institutional category would create an incentive
for HHAs to potentially encourage hospitalizations for potentially
higher reimbursement.
Response: We appreciate the commenters' concerns regarding
potential impacts to those patients who may have experienced an event
in a setting that is not defined as acute or post-acute, including
visits to emergency departments. However, for the purposes of the PDGM,
we will only include those stays in the institutional category that are
considered institutional stays in other Medicare settings. As described
in detail in the CY 2019 HH PPS proposed rule, we analyzed the resource
use of admission source categories, including ED visits and
observational stays, as well as corresponding payment weights based
upon the resource use demonstrated in existing home health data (83 FR
32340). Our findings indicate that the volume of patients utilizing
such settings prior to a home health episode is very low. Given that
the proportion of home health periods with admissions from ED visits
and observational stays is low relative to community and institutional
counterparts, we believe that creating a third community admission
source category for observational stays and ED visits could potentially
introduce added complexity into the payment system in order to address
a small portion of home health stays, which could in turn lead to the
creation of payment groups that contain very few stays with very little
difference in case-mix weights across the landscape of groups.
Moreover, we remain concerned that a third admission source category
for observational stays and ED visits could potentially create an
incentive for HHAs to encourage outpatient encounters both prior to a
30-day period of care or within a 30-day period of care within 14 days
of the start of the next 30-day period, thereby potentially increasing
costs to the Medicare program overall. For all of these reasons, we
believe that incorporating HH stays with preceding observational stays
and ED visits into the community admission category is most appropriate
at this time.
While we recognize that there is more recent use of Ambulatory
Surgery Centers (ASCs) for certain joint replacement surgeries, we do
not have sufficient data at this time to determine the impact on home
health resource use for beneficiaries coming from an ASC facility after
these types of surgeries. As mentioned previously, we will only include
those stays that are considered institutional stays in other Medicare
settings and where ``institutional'' refers to discharges from acute-
care hospitals, IRFs, LTCHs, IPFs, and SNFs. Therefore, a discharge
from an ASC does not meet the definition of ``institutional''.
Likewise, discharge from hospice care would not be considered an
institutional discharge, nor would we expect large enough numbers of
beneficiaries discharging from hospice to home health to warrant such
an inclusion.
However, we note that as we receive and evaluate new data related
to the provision of Medicare home health care under the PDGM, we will
continue to assess the payment levels for admission source within a
home health period and give consideration to any cost differentiation
evidenced by the resources required by those home health patients with
a preceding outpatient event.
Comment: Several commenters stated that the addition of the
admission source category and potential payment differential could
negatively affect agencies' ability to provide the care for
beneficiaries in the community and that the admission source categories
placed a higher value on care provided to a beneficiary referred to
home health care from an acute setting. Several commenters stated that
home health community entrants are provided education and oversight as
well as preventative and maintenance therapy and care, citing the Jimmo
Settlement Agreement.\16\ Commenters assert that such maintenance care
ultimately prevents beneficiaries from requiring an admission to a more
expensive hospital setting. Several commenters stated that the
admission source element of the PDGM would lead to reduced access to
home-based care, which may, in turn, result in an increase in emergency
department visits, an increase in hospital admissions, and increased
use of high cost institutional care for patients. The commenters
further suggested that the maintenance interventions provided produce
value for the Medicare system and that these savings should be
reflected through higher payment to HHAs for the care of community
entrants.
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\16\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Jimmo-Settlement-Agreement.pdf.
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Response: HHAs should continue to provide the most appropriate care
to Medicare home health beneficiaries, regardless of admission source
or any other category related to home health payment in accordance with
the home health CoP requirements at Sec. 484.60. As we noted in the CY
2019 HH PPS proposed rule, the primary goal of home health care is to
provide restorative care when improvement is expected, maintain
function and health status if improvement is not expected, slow the
rate of functional decline to avoid institutionalization in an acute or
post-acute care setting, and/or facilitate transition to end-of-life
care as appropriate (83 FR 32375). The primary goal of the HH PPS is to
align payment with the costs of providing home health care. As
described in the CY 2019 HH PPS proposed rule, we have developed the
PDGM categories and corresponding payment weights based upon the
resource use demonstrated in existing home health data, which shows
that differentiated amounts are merited between the two admission
sources (83 FR 32375). Furthermore, in our CY 2000 HH PPS final rule,
commenters asserted that patients admitted to home health from the
hospital were often more acutely ill and resource-intensive than other
patients, particularly when compared with beneficiaries who had no
institutional care prior to admission (64 FR 41147). Commenters further
noted that home health beneficiaries referred from institutional
settings typically required more visits and more intensive teaching.
Given our analyses as well as clinical observations regarding the
resource needs of the institutional entrants to home health, we believe
that differentiated admission source categories are merited. We will
continue to monitor home health data for impacts of this payment policy
change, potentially evaluating for increases in hospital admissions
during home health stays, poorer quality outcomes, and increases in
costs for the overall Medicare program, and we will make refinements to
the payment system as appropriate.
Comment: Several commenters expressed concern regarding the
operational aspects of the admission source category, requesting
guidance for retroactive adjustments, plans for the claims readjustment
process due to institutional claim issues, definitions for timely
filing, and guidance regarding when occurrence codes may be utilized
(for example, for both non-Medicare and Medicare institutional stays).
Several commenters expressed concern that the usage of occurrence codes
for institutional admissions will increase burden on providers, cause
difficulties for HHAs when having to rely on institutional providers to
submit timely claims to Medicare, and create
[[Page 56469]]
challenges when modifications to home health payments are made
retroactively due to the re-categorization of a community stay when an
institutional claim was not submitted correctly. Several commenters
requested that CMS clarify the length of time that a HHA would have to
resubmit a home health claim when it learns of a non-Medicare
institutional stay occurring within 14 days of the home health
admission. A commenter expressed concern regarding the usage of the
OASIS for identification of institutional admission sources.
Response: As described in the CY 2019 HH PPS proposed rule, we have
developed automated claims processing procedures with the goal of
reducing the amount of administrative burden associated with the
admission source category of the PDGM (83 FR 32375). For example,
Medicare systems will automatically determine whether a beneficiary has
been discharged from an institutional setting for which Medicare paid
the claim, using information used during claims processing to
systematically identify admission source and address this issue. When
the Medicare claims processing system receives a Medicare home health
claim, the systems will check for the presence of a Medicare acute or
PAC claim for an institutional stay. If such an institutional claim is
found, and the institutional stay occurred within 14 days of the home
health admission, our systems will trigger an automatic adjustment of
the corresponding HH claim to the appropriate institutional category.
Similarly, when the Medicare claims processing system receives a
Medicare acute or PAC claim for an institutional stay, the systems will
check for the presence of a subsequent HH claim with a community
payment group. If such a HH claim is found, and the institutional stay
occurred within 14 days of 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. The OASIS
assessment will not be utilized in evaluating for admission source
information.
Moreover, we proposed that newly-created occurrence codes would
also be established, allowing HHAs to manually indicate on Medicare
home health claims that an institutional admission had occurred prior
to the processing of an acute/post-acute Medicare claim, if any, by
Medicare systems in order to receive the higher payment associated with
the institutional admission source sooner (83 FR 35312). However, the
usage of the occurrence codes is limited to situations in which the HHA
has information about the acute or PAC stay. We also noted that the use
of these occurrence codes would not be limited to home health
beneficiaries for whom the acute/post-acute claims were paid by
Medicare. HHAs would also use the occurrence codes for beneficiaries
with acute/post-acute care stays paid by other payers, such as the
Veterans Administration (VA).
If a HHA does not include the occurrence code on the HH claim
indicating that a home health patient had a previous institutional
stay, processed either by Medicare or other institutions such as the
VA, such an admission will be categorized as ``community'' and paid
accordingly. However, if later a Medicare acute/post-acute 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 would be automatically adjusted
and re-categorized as an institutional admission and appropriate
payment modifications would be made. If there was a non-Medicare
institutional stay occurring within 14 days of the home health
admission but the HHA was not aware of such a stay, upon learning of
such a stay, the HHA would be able to resubmit the HH claim that
included an occurrence code, subject to the timely filing deadline, and
payment adjustments would be made accordingly.
Again, however, we note that the Medicare claims processing system
will check for the presence of an acute/post-acute Medicare claim for
an institutional stay occurring within 14 days of the home health
admission on an ongoing basis and automatically assign the home health
claim as ``community'' or ``institutional'' appropriately. As a result,
with respect to a HH claim with a Medicare institutional stay occurring
within 14 days of home health admission, we will not require the
submission of an occurrence code in order to appropriately categorize
the HH claim to the applicable admission source. With respect to a HH
claim with a non-Medicare institutional stay occurring with 14 days of
home health admission, a HHA would need to submit an occurrence code on
the HH claim in order to have the HH claim categorized as
``institutional'' and paid the associated higher amount.
Additionally, we plan to provide education and training regarding
all aspects of the admission source process and to develop materials
for guidance on claims adjustments, for resolution of claims processing
issues, for defining timely filing windows, and for appropriate usage
of occurrence codes through such resources as the Medicare Learning
Network. We will also update guidance in the Medicare Claims Processing
Manual as well as the Medicare Benefit Policy Manual as appropriate
with detailed procedures. We will also work with the MACs to address
any concerns regarding the processing of home health claims as well as
develop training materials to facilitate all aspects of the transition
to the PDGM, including the unique aspects of the admission source
categories.
With regards to the length of time for resubmission of home health
claims that reflect a non-Medicare institutional claim, all appropriate
Medicare rules regarding timely filing of claims will still apply.
Procedures required for the resubmission of home health claims will
apply uniformly for those claims that require editing due to the need
to add or remove occurrence codes. Details regarding the timely filing
guidelines for the Medicare program are available in the Medicare
Claims Processing Manual, Chapter 1--General Billing Requirements,
which is available at the following website: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c01.pdf.
Additionally, adjustments to any re-submitted home health claims will
be processed in the same manner as other edited Medicare home health
claims. Additionally, we plan to perform robust testing within the
Medicare claims processing system to optimize and streamline the
payment process.
Comment: Another commenter requested details regarding the process
by which HHAs should verify a non-Medicare institutional stay.
Response: As we noted in in the CY 2019 HH PPS proposed rule, we
expect home health agencies would utilize discharge summaries from all
varieties of institutional providers (that is, Medicare and non-
Medicare) to inform the usage of these occurrence codes, and these
discharge documents should already be part of the beneficiary's home
health medical record used to support the certification of patient
eligibility as outlined in Sec. 424.22(c) (83 FR 32340). Providers
should utilize existing strategies and techniques for verification of
such stays and incorporate relevant clinical information into the plan
of care, as is already required by the Medicare CoPs.
Comment: Several commenters expressed concern that the use of
occurrence codes will lead to claims
[[Page 56470]]
denials by MACs and stated that MAC staff will require training in
order to ensure appropriate application of the admission source policy
as well as avoid any unintended consequences.
Response: We intend to provide education and training regarding the
usage of the admission source occurrence codes to providers through
such tools are Medicare Learning Network articles. We are also working
closely with the MACs to ensure proper processing of home health claims
under the new PDGM. Additionally, as we noted in in the CY 2019 HH PPS
proposed rule, while a home health claim with a non-Medicare
institutional admission source can be categorized by the HHA as an
institutional admission and paid accordingly, we may conduct medical
review if deemed appropriate (83 FR 35312).
Comment: Several commenters expressed concern regarding our
proposal to potentially conduct post-payment medical review of home
health claims in order to assess whether a home health admission was
preceded by an institutional stay, asserting that HHAs should not be
held responsible for other providers' claim activity. The commenters
stated that post-payment medical review for instances in which HHAs
manually indicate on the claim an institutional admission source, and
the institution's claim for an acute/post-acute stay is subsequently
denied or not filed in a timely manner could be problematic. The
commenters stated that a denial for the acute/post-acute stay could be
due to a number of reasons of which the HHA has no knowledge or
involvement and noted that any denial of an institutional claim or non-
timely filing of a claim, would be outside of the control of the HHAs.
Response: Our evaluation process within the Medicare claims
processing system will check for the presence of an acute/post-acute
Medicare claim for an institutional stay occurring within 14 days of
the home health admission on an ongoing basis. Under this approach, the
Medicare systems would only evaluate for whether an acute/post-acute
Medicare claim for an institutional stay occurring within 14 days of
the home health admission was processed by Medicare, not whether it was
paid. Therefore, we do not expect that a home health claim will be
denied due to unpaid Medicare claims for preceding acute/post-acute
admissions. Moreover, we note that providers would have the option to
submit the occurrence code indicating a preceding institutional stay in
order to categorize the home health admission as ``institutional.'' If
in the case of a Medicare institutional stay, upon review after finding
no Medicare acute or post-acute care claims in the National Claims
History, and there is documentation of a Medicare acute or post-acute
care stay within the 14 days prior to the home health admission, but
the institutional setting did not submit its claim in a timely fashion
or at all, we would permit the institutional categorization for the
payment of the home health claim through appropriate administrative
action. Similarly, in the case of a non-Medicare institutional stay, if
documentation of a non-Medicare acute or post-acute care stay within
the 14 days prior to the home health admission, is found, we would
permit the categorization of the home health claim as
``institutional''. However, if upon medical review after finding no
acute or post-acute care Medicare claims in the National Claims
History, and there is no documentation of an acute or post-acute care
stay, either a Medicare or non-Medicare stay, within 14 days of the
home health admission, we would correct the overpayment and re-
categorize the stay as community. If upon medical review after finding
no Medicare acute or post-acute care claims in the National Claims
History and we find that an HHA is systematically including occurrence
codes that indicate the patient's admission source was
``institutional,'' but no documentation exists in the medical record of
Medicare or non-Medicare stays, we would refer the HHA to the zone
program integrity contractor (ZPIC) for further review, including any
potential administrative action.
Comment: A commenter suggested that we only conduct post-payment
review for HHAs that have claims that are consistently associated with
acute/post-acute claim denials, or whose utilization pattern of acute/
post-acute occurrence codes is aberrant when compared with their peers,
which the commenter asserts would ensure a more equitable approach
toward conducting post-payment medical review of home health claims.
Response: We appreciate the commenter's suggestions regarding
targeted approaches for medical review after the implementation of the
admission source element of the PDGM, and we will consider such metrics
in the development of any targeted reviews.
Comment: Another commenter expressed concerns regarding operational
aspects of the admission source portion of the PDGM, stating that if
the institutional stay were billed very late in the timely filing
period, the HHA might not receive an appropriate admission source
adjustment within the PDGM. The commenter also expressed concern
regarding the timely filing window for HHAs, asking if we will increase
the timely filing period for home health agencies. The commenter also
wanted to understand how home health agencies will know if
institutional providers are submitting their claim correctly and
meeting the necessary criteria. Additionally, the commenter asked why
we were not allowing payment to the home health agency if the agency's
billing is submitted appropriately based on the information currently
at hand and later recalculate and adjust payment if necessary. The
commenter also asked if discharge summaries received by home health
from external institutions will serve as ``proof'' in the event of
medical review. The commenter also asked what would transpire if an
institutional provider decided post-discharge that the inpatient
admission did not meet inpatient criteria when discharge summary
documents still indicate the patient was being discharged to home
health following a qualifying inpatient stay.
Response: We appreciate the commenter's questions regarding the
operational aspects of the admission source category within the PDGM.
With respect to any issues around a Medicare institutional claim
submitted near the end of the timely filing period, if the
institutional stay is billed very late in the timely filing period,
that institutional stay claim would trigger an automatic adjustment to
the HH claim whenever it is received by CMS's claims processing system
and the HHA would be paid appropriately. If there was a non-Medicare
institutional stay occurring within 14 days of the home health
admission but the HHA was not aware of such a stay, upon learning of
such a stay, the HHA would be able to resubmit the HH claim that
included an occurrence code to indicate an institutional admission
source, subject to the timely filing deadline, and payment adjustments
would be made accordingly. Regarding timely filing timeframes, we do
not have the authority to extend timely filing timeframes as they are
mandated by statute. However, the HHA may utilize the newly-established
occurrence codes to indicate an institutional admission source without
dependency on the claims submission by the institutional provider.
Additionally, we reiterate that the HHA is not dependent on the
institutional provider's ``correct'' submission of the institutional
claim for appropriate admission source categorization, as HHAs will
have the
[[Page 56471]]
option of including the relevant occurrence codes to indicate an HH
admission from an institutional provider separate and apart from any
claims submission by the institutional provider. In the case of a
Medicare institutional stay, if the institutional setting did not
submit its claim in a timely fashion, or at all, but there is
documentation of a Medicare acute or PAC stay within the 14 days prior
to the home health admission, we would permit the institutional
categorization for the payment of the home health claim through
appropriate administrative action. Similarly, in the case of a non-
Medicare institutional stay, if documentation of a non-Medicare acute
or post-acute care stay within the 14 days prior to the home health
admission, is found, we would permit the categorization of the home
health claim as ``institutional''. Regarding the usage of discharge
summaries as evidence of a prior institutional stay, such summaries may
be considered in the assessment of the appropriateness of the usage of
an occurrence code indicating admission to HH from an institutional
setting and determinations will be made based upon the evidence
gathered. Regarding a scenario where an institutional provider
determines post-discharge that an admission did not meet inpatient
criteria but the discharge summary utilized by an HHA indicated that
the patient was being discharged to home health following a qualifying
inpatient stay, the home health agency would not be left with a non-
covered claim. However, the home health claim may be paid as non-
institutional rather than institutional, given the source of the
admission. Furthermore, we note that details regarding the claims
processing instructions for Medicare home health claims will be updated
in our Medicare Claims Processing Manual. We plan to provide education
and training regarding all aspects of the admission source process and
to develop materials for guidance on claims adjustments, and for
appropriate usage of occurrence codes.
Final Decision: We are finalizing our proposal to establish two
admission source categories for grouping 30-day periods of care under
the PDGM--institutional and community--as determined by the healthcare
setting utilized in the 14 days prior to home health admission. Thirty-
day periods 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 the 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 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 (SNF, IRF, or LTCH) or IPF stays that occur during a previous 30-
day period and within 14 days of a subsequent, contiguous 30-day period
of care (that is, the admission date and from date for the subsequent
30-day period of care do not match) as institutional, 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. If the patient was discharged and then readmitted to home
health, the admission date and ``from'' date on the 30-day claim would
match and the claims processing system will look for an acute or a
post-acute care stay within 14 days of the home health admission date.
This admission source designation process would be applicable to
institutional stays paid by Medicare or another payer. All other 30-day
periods would be designated as community admissions. For the purposes
of a RAP, we would only adjust the final home health claim submitted
for source of admission. For example, if a RAP for a community
admission was submitted and paid, and then an acute or PAC Medicare
claim was submitted for that patient before the final home health claim
was submitted, we would not adjust the RAP and would only adjust the
final home health claim so that it reflected an institutional
admission. Additionally, HHAs would only indicate admission source
occurrence codes on the final claim and not on any RAPs submitted. As
noted previously, we plan to provide future training and guidance of
operational aspects of claims processing under the PDGM especially
regarding the admission source case-mix variable.
6. Clinical Groupings
In the CY 2019 HH PPS proposed rule (83 FR 32340), we proposed
grouping 30-day periods of care into six clinical groups:
Musculoskeletal Rehabilitation, Neuro/Stroke Rehabilitation, Wounds--
Post-Op Wound Aftercare and Skin/Non-Surgical Wound Care, Behavioral
Health Care (including Substance Use Disorder), Complex Nursing
Interventions, and Medication Management, Teaching, and Assessment
(MMTA). We stated that by placing periods of care into clinical groups
reflecting the primary reason the patient is receiving home health, as
determined by the principal diagnosis on the claim, we would capture
the most common types of care provided and more accurately align
payments with the cost of providing care (that is, resource use).
In response to comments on the CY 2018 HH PPS proposed rule (82 FR
35317) and a Technical Expert Panel (TEP) held in February 2018, we
conducted further analysis on the division of the MMTA clinical group
into subgroups. We conducted a thorough review of all the diagnosis
codes grouped into the MMTA group and we grouped codes into MMTA
subgroups based on feedback from public comments, which mainly focused
on cardiac, oncology, infectious, and respiratory diagnoses. We created
the additional subgroups (Surgical Aftercare, Cardiac/Circulatory,
Endocrine, GI/GU, Infectious Diseases/Neoplasms/Blood Forming Diseases,
Respiratory, and Other) based on data that showed above-average
resource use for the codes in those groups, and then combined certain
groups that had a minimal number of codes.
Similar to the initial Home Health Groupings Model (HHGM) analysis
conducted in 2016 that was discussed in the CY 2018 HH PPS proposed
rule, results showed that the change in case-mix weights, as well as
impacts to the other case-mix variables (admission source/timing,
comorbidity adjustment) was minimal for the 30-day periods assigned to
these subgroups compared to the case-mix weights without the subgroups.
We showed that overall, using the MMTA subgroup model would result in
more payment groups but no significant differences in case-mix weights
across those groups. For that reason, in the CY 2019 HH PPS proposed
rule, we proposed to retain the six clinical groups as shown in Table
26, and not divide the MMTA clinical group into subgroups. A complete
list of ICD-10-CM codes and their assigned clinical groupings is posted
on the CMS HHA Center web page (https://
[[Page 56472]]
www.cms.gov/center/provider-Type/home-Health-Agency-HHA-Center.html).
More information on the analysis and development of the groupings can
be found in the CY 2019 HH PPS proposed rule as well as the Summary of
the Home Health Technical Expert Panel Meeting.\17\ However, we
solicited comments from the public on whether there may be other
compelling reasons why the MMTA clinical group should be broken out
into subgroups, despite analysis indicating that additional subgroups
do not result in significant differences in case-mix weights. We noted
that we also planned to continue to examine trends in reporting and
resource utilization to determine if future changes to the clinical
groupings are needed after implementation of the PDGM.
---------------------------------------------------------------------------
\17\ https://www.cms.gov/center/provider-type/home-health-
agency-HHA-center.html.
[GRAPHIC] [TIFF OMITTED] TR13NO18.032
The following is a summary of the public comments received on the
proposed clinical groups under the PDGM and our responses:
Comment: Many commenters supported the patient-centered approach to
grouping patients by clinical characteristics, and appreciated that
additional codes were added to the PDGM in comparison to the HHGM.
Response: We appreciate these comments and thank the commenters for
their support of the clinical groupings as defined in the CY 2019 HH
PPS proposed rule.
Comment: Many commenters reiterated concern that the MMTA group was
too large (that is, too many 30-day periods group into the MMTA
clinical group under the PDGM) and stated preference for more
specificity within this group despite analysis showing a lack of
variation in resource use across subgroups. A commenter specifically
noted that the groupings exclude heart failure and pulmonary clinical
groups, which are two medically complex categories that result in
significant time and resource use in order to prevent hospital
readmissions.
Response: As discussed in the CY 2019 HH PPS proposed rule, health
teaching; guidance and counseling; case management, treatments and
procedures; and surveillance are integral in the care of the majority
of home health patients. Additionally, these important interventions
are often the primary reason for home health services. However, because
these interventions cross the spectrum of diagnoses, the MMTA clinical
group included the largest number of 30-day periods among the proposed
clinical groups in the PDGM. Despite additional analysis showing very
little variation in resource use after sub-dividing MMTA into smaller
subgroups, we understand stakeholder preference to capture the
distinctions in care provided to patients within this group. The
majority of commenters still expressed concern with the high number of
diagnoses that grouped into the MMTA and preferred greater specificity
over having fewer HHRGs.
Therefore, we will create 7 additional clinical groups to replace
the comprehensive MMTA group. These subgroups were selected based on
public comments in response to the CY 2018 HH PPS proposed rule and
these comments mainly focused on cardiac, oncology, infectious disease,
and respiratory diagnoses.\18\ We created the additional subgroups
based on data that showed above-average resource use for codes in those
groups, and then combined certain groups that had a minimal number of
codes. These subgroups were presented to the TEP convened in February,
2018 and were detailed in the CY 2019 HH PPS proposed rule; commenters
were generally supportive of these seven subgroup designations. As
such, these MMTA subgroups will be called:
---------------------------------------------------------------------------
\18\ Public comments can be viewed at: Regulations.gov, ID: CMS-
2017-0100-0002: Medicare and Medicaid Programs: Home Health
Prospective Payment System Rate Update, etc.
MMTA--Surgical Aftercare
[[Page 56473]]
MMTA--Cardiac/Circulatory
MMTA--Endocrine
MMTA--GI/GU
MMTA--Infectious Disease/Neoplasms/Blood-forming Diseases
MMTA--Respiratory
MMTA--Other
The addition of these 7 new groups generated a new table of case-
mix weights for the model. The PDGM will now contain 432 case-mix
groups. We agree with commenters that greater specificity in the MMTA
clinical group will help distinguish differences in care and allow for
greater transparency in resource use. We also believe that with the
elimination of therapy thresholds, having more discrete subgroups
within this clinical group may result in more variation in resource use
over time.
Comment: Several commenters submitted specific diagnosis codes that
they believe should be reassigned to different clinical groups or added
to the grouper tool. Another commenter stated that any existing ICD-10-
CM diagnosis code should be considered when assigning a clinical group.
Several commenters submitted new codes effective for October 1, 2018
that were not in the grouper tool released with the proposed rule on
July 2, 2018.
Response: We thank commenters for thoroughly reviewing the PDGM
Grouper tool and providing questions and detailed examples regarding
the grouping of specific codes. As discussed in the CY 2019 HH PPS
proposed rule, one of the main goals of the PDGM is to clearly account
for resource use by highlighting the main reason for home health
services. The ICD-10-CM code list is an exhaustive list that contains
many codes that do not support the need for home health services and so
are not appropriate as principal diagnosis codes for grouping home
health periods into clinical groups. Dental codes, for example, are
included in the ICD-10-CM code list, but are not Medicare covered
services. Others are Medicare covered codes, but are not relevant to
home health, for example, codes that indicate death as the outcome.
Another reason a code is not appropriate for grouping home health
periods into clinical groups is because of coding guidelines. For
example, this would include codes listed out of sequence when ICD-10
coding conventions indicate certain codes in which the underlying
condition must be listed first (that is, Parkinson's disease must be
listed prior to Dementia if both codes were listed on a claim).
In addition to coding guidelines, we also looked at clinical
practice guidelines and the interventions and skilled care involved in
managing the diagnosis at home. We believe these guidelines provide
valuable information for establishing a plan of care and support home
health resource use. For instance, an infection of an amputation stump
may only require treatment with antibiotics, whereas management of
necrotic tissue always involves debridement and subsequent wound care
in order to allow wound healing to take place. Thus, necrosis of an
amputation stump clearly denotes wound care. For a period to be grouped
into the wound category, the diagnosis on the claim must reflect a
break in skin integrity for which clinical practice guidelines involve
wound care necessitating skilled nursing services. A diagnosis simply
indicating infection may or may not necessitate wound care.
We also expect that whenever possible, the most specific code that
describes a medical disease, condition, or injury should be documented.
For instance many codes contain the word ``unspecified.'' Generally,
``unspecified'' codes are used when there is lack of information about
location or severity of medical conditions in the medical record.
However, we would expect a provider to use a precise code whenever more
specific codes are available. Furthermore, if additional information
regarding the diagnosis is needed, we would expect the HHA to follow-up
with the referring provider in order to ensure the care plan is
sufficient in meeting the needs of the patient. We believe that a vague
principal diagnosis does not clearly identify the primary reason for
home health, and subsequently leads to ambiguous resource use. For
example, T14.90 ``Injury, unspecified'', lacks clarity regarding the
type and extent of injury and therefore, fails to indicate and support
the needed resources. Additionally, the ICD-10-CM code set includes
laterality. We believe a home health clinician should not report an
``unspecified'' code if that clinician can identify the side or site of
a condition. For example, a home health clinician should be able to
state whether a fracture of the arm is the right or left arm.
Similarly, many of the codes that indicate pain or contractures as
the primary diagnosis, for example M54.5, Low back pain or M62.422,
Contracture of muscle, right hand, although site specific, do not
indicate the cause of the pain or contracture. We would expect a more
definitive diagnosis indicating the cause of the pain or contracture,
as the reason for the skilled care, in order to appropriately group the
home health period.
We also 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. While we recognize that the coding
guidelines allow for the reporting of signs, symptoms, and less well-
defined conditions, HHAs are required to establish an individualized
plan of care in accordance with the home health CoPs at Sec. 484.60.
The plan of care must specify the services necessary to meet the
patient-specific needs as identified during the comprehensive
assessment. This includes identification of the responsible
discipline(s), and anticipated measurable outcomes as a result of
implementing and coordinating the plan of care. We 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. Likewise, we believe that clinically it is important for home
health clinicians to have a clearer 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. 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
[[Page 56474]]
should not be used as a primary 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 exists to 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.
Another commonly reported diagnosis, M62.81, ``Muscle weakness,
generalized'' is extremely vague. Generalized muscle weakness, while
obviously a common condition among recently hospitalized patients does
not clearly support a rationale for skilled services and does not lend
itself to a comprehensive plan of care. In Sec. 409.44(c)(1)(ii) we
state 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, in the 2008 HH PPS final
rule, we identified ``muscle weakness (generalized)'' 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). Specifically, the 2008 HH PPS final rule stipulated 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 believe 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 that more clearly describe a
patient's need for home health. With respect to commenter rationale for
coding ``Muscle weakness, generalized'' in response to severe
deconditioning and weakness due to extended hospitalization, we believe
a more appropriate code would be one of the muscle wasting and atrophy
codes as grouped into the musculoskeletal group. Muscle wasting and
atrophy would indicate the reason for the generalized muscle weakness
and provide more clarity for the necessity of skilled services.
Using these guidelines, we worked with certified coders to review
all of the codes submitted with commenter feedback. We included the new
codes added with respect to Fiscal Year 2018 (for use beginning October
1, 2017) and with respect to Fiscal Year 2019 (for use beginning
October 1, 2018) and grouped the MMTA diagnosis codes into the
appropriate sub-groups. We remind commenters that the ICD 10-CM code
list is updated each fiscal year with an effective date of October 1st.
Because of an annual October effective date for updated ICD 10-CM
codes, the HH PPS is subject to two Grouper releases, one in October
and one in January, to ensure that claims are submitted with the most
current code set available. Additionally, we re-grouped many of the
codes submitted by commenters based on feedback we received and changed
the clinical grouping of many additional codes based on commenter
rationale. For example, we agree with commenters regarding many of the
S and T codes where the fracture and/or injury is unspecified, but the
site is specified. We maintain that the site of injury and/or fracture
should be identified; however, we believe that, as the treatment or
intervention would likely not change based on the exact type of injury
or fracture, many of these codes are appropriate to group the period
into a clinical group. These codes were changed to either the
musculoskeletal group or the wounds group. We also agreed with
commenters regarding some of the combination diagnosis/symptom codes.
For example, we re-grouped I13.2, Hypertensive heart and chronic kidney
disease with heart failure and with stage 5 chronic kidney disease, or
end stage renal disease into MMTA- Cardiac/Circulatory, as despite the
likelihood that the patient is covered under the End Stage Renal
Disease (ESRD) benefit, the patient may also be receiving home health
services for hypertension. We also agree that Z46.6, Encounter for
fitting and adjustment of urinary device should be grouped into the
Complex Nursing Interventions group.
Regarding A41.0, Sepsis due to Staphylococcus aureus and A40.0,
Sepsis due to streptococcus, group A, as guidelines state that a sepsis
diagnosis should be assigned the appropriate code for the underlying
systemic infection, these codes will be classified under MMTA--
Infectious Disease/Neoplasms/Blood-forming Diseases. With regards to
Z45.2, Encounter for adjustment and management of VAD, per coding
guidelines, Z45.2 can be reported as the principal diagnosis and will
remain in the Complex Nursing Interventions group. However, we
recognize that coding guidelines indicate that if treatment is directed
at current, acute disease, then the disease diagnosis code should be
reported first, followed by the Z aftercare codes. Therefore, in a case
where the patient is receiving an IV antibiotic for sepsis, as the HHA
is required to code sepsis as the primary diagnosis, the Z code must be
listed as the first secondary diagnosis code listed on the claim in
order to group the period into the Complex Nursing Interventions group.
Ultimately we believe that precise coding allows for more
meaningful analysis of home health resource use and ensures that
patients are receiving appropriate home health services as identified
on an individualized plan of care. We thank the commenters for their
in-depth review and suggested changes to the ICD-10-CM code assignments
for the clinical groups under the PDGM. We note that we did regroup
additional codes to the ones identified in this section, based on the
reasons previously discussed, and we encourage HHAs to continue to
review the list of diagnosis codes in the PDGM Grouper Tool posted with
the final rule on the HHA Center web page (https://www.cms.gov/center/
provider-Type/home-Health-Agency-HHA-Center.html). Commenters are
encouraged to continue to submit comments to the home health policy
mailbox ([email protected]) regarding diagnosis coding under
the PDGM. We will continue to review ICD-10-CM code assignments for the
clinical groups under the PDGM and make future refinements as
necessary, including refinements to reflect new codes added to the ICD
10-CM code list.
Comment: Another commenter expressed concern about patients grouped
into the MMTA group who experience a change of condition that warrants
additional resources during a period of care that is not properly
accounted for under the PDGM. The commenter gave the example of an MMTA
patient who experiences a fall and thereafter requires therapy services
which are not accounted for in the case-mix weight based on the HHRG.
The commenter suggested that ``it may be necessary for CMS to reinstate
a payment adjustment similar to the Significant Change in Condition
(``SCIC'') adjustment when HHGM is
[[Page 56475]]
implemented to address these patients' needs.''
Response: If the primary diagnosis changes between the first and
the second 30-day periods, then the claim for the second 30-day period
would reflect the new diagnosis, and providers would not change the
claim for the first 30-day period. We note that if a patient
experienced a significant change in condition before the start of a
subsequent, contiguous 30-day period, for example due to a fall, in
accordance with Sec. 484.55(d)(1)(ii), the HHA is required to update
the comprehensive assessment. Furthermore, in accordance with Sec.
484.18(b) the total plan of care is reviewed by the attending physician
and HHA personnel as often as the severity of the patient's condition
requires, but at least once every 60 days or more frequently when there
is a beneficiary elected transfer; a significant change in condition
resulting in a change in the case-mix assignment; or a discharge and
return to the same HHA during the 60-day episode. A follow-up
assessment would be submitted at the start of the second 30-day period
to reflect the change in the functional level and the second 30-day
claim would be grouped into its appropriate case-mix group accordingly.
In this respect, two 30-day periods can have two different case-mix
groups to reflect any changes in patient condition. This is different
from the current payment system where the case-mix group does not
change in the middle of a 60-day episode. However, similar to the
current system, the case mix group cannot be adjusted within each 30-
day period. 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 a claims adjustment if the assessment is
received after the claim has been submitted, if the assessment items
would change the payment grouping.
Comment: A few commenters questioned what will happen when a
provider who has a claim returned for a principal diagnosis code that
does not group into one of the six clinical groups and the provider
corrects the claim by changing the principal diagnosis to one that
corresponds to a clinical category. The commenter expressed concern
that this may be regarded as ``up-coding'' and wanted to know how CMS
would prevent this.
Response: As we are posting a complete list of ICD-10-CM codes that
are available at the time of this final rule with comment period and
their assigned clinical groupings on the CMS HHA Center web page, HHAs
should have ample time to become familiar with codes that would be used
to group 30-day periods of care into the 12 clinical groupings,
therefore we believe the number of returned claims should be minimal as
HHAs will avoid listing codes as the principal diagnosis code on the
home health claim knowing in advance that such claims will be returned
to the provider for more appropriate or specific coding. Returning a
claim for more appropriate or specific coding would not be considered
as ``up-coding'' assuming the documentation clearly supports the need
for services. Furthermore, it is required per Sec. 409.43(c)(4) that
any changes in the plan of care must be signed and dated by a
physician. If a claim is returned for more specific coding, then it is
expected that the diagnosis on the plan of care will be corrected as
well.
Under the PDGM, case-mix assignment is based, in part, on certain
items in patient assessments completed by home health agencies and the
diagnoses reported on the home health claim. Thus, if the average case-
mix weight of Medicare home health patients increases over time, the
extent to which case-mix increases reflect real changes in patient
characteristics versus nominal case-mix changes attributable to changes
in coding practices (more commonly referred to as ``up-coding'') has
been examined. CMS examines the proportion of total case-mix change
that is nominal versus real across all HHAs on an annual basis as this
has important implications for determining home health payment rates
that are accurate and reasonable. We do not determine nominal case-mix
changes on a case-by-case basis.
Comment: A commenter indicated that SNFs and HHAs should use the
same diagnosis classification system. Another commenter noted that
providers do not generally determine their treatment based on a
patient's clinical diagnosis, but rather ``treat the body structure and
impairments derived from the diagnosis within each patient's unique
environment.'' This commenter also suggested building a ``Diagnosis-
Driven Groupings Model.''
Response: We stated in the CY 2019 HH PPS proposed rule that we
agree that diagnosis alone does not provide the entire clinical picture
of the home health patient. However, we maintain that a diagnosis is
important to the overall care of a patient, as it crosses disciplines
when identifying signs and symptoms of a disease or condition that may
impact care planning. We stated that we believe that different
healthcare disciplines use the signs and symptoms associated with a
diagnosis to apply their own approach and skill set to treat the
patient. We also reiterated that the clinical group is only one aspect
of the PDGM, and that the combination of the clinical group with the
other aspects of the PDGM, such as functional level and comorbidity
adjustment, provide a more complete picture of the patient, allowing a
thorough understanding of the resources needed for treatment. Payment
would, in turn, be aligned with the more clearly defined resource use.
It is unclear why the commenter suggested a ``Diagnosis-Driven
Groupings Model,'' as the preceding comment indicates a rejection of
the concept of grouping patients by diagnosis, but rather favors
grouping patients by impairment. We would argue that, as the clinical
group is determined by the patient's primary diagnosis, this aspect of
the PDGM is diagnosis-driven. While CMS is making strides in aligning
the patient assessment instruments, and in some cases aligning the
case-mix adjustment methodology by virtue of removing therapy visit/
minute thresholds, across the four post-acute care settings; we note
that the SNF and HH benefits do not include the same set of services.
For example, while not covered under the Medicare home health benefit,
SNF covered services include room and board, medications, and ambulance
transportation. Based on differences in setting of care and coverage
between the SNF and Home Health benefits, we believe that there are
appropriate reasons for the case-mix adjustment methodology to differ
between the two settings.
Comment: Some commenters stated that patients who are not
categorized into either the musculoskeletal or neuro rehabilitation
groups, but who require physical therapy, occupational therapy, or
speech-language pathology services may be at risk for receiving an
inordinately low level of rehabilitation due to the allocation of
resources to address those patients' other conditions. Another
commenter indicated this undermined Jimmo Settlement Agreement and the
provision of maintenance therapy. A commenter suggested removing
therapy thresholds in stages. Another commenter also requested that CMS
institute a mechanism within the PDGM to hold providers accountable for
the delivery of appropriate, medically necessary care and provide
safeguards to ensure how the delivery of therapy services aligns with
individual patient characteristics and clinical needs.
Response: With respect to the provision of therapy services as they
[[Page 56476]]
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 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.
Ultimately, case-mix adjustment takes into account the resource use
of different groups of home health patients, and although not the sole
determinant, diagnosis has always been a factor. Highlighting the
principal diagnosis in the case-mix model helps to define the primary
reason for home health, but does not in any way dictate what services
should be included in the plan of care. Therefore, if the primary
reason for home health care is for maintenance purposes with the
primary need being therapy, this would be indicated on the plan of care
and the patient would likely be grouped into one of the therapy groups.
The home health benefit is a bundled payment. It allows home health
agencies the discretion to allocate resources based on their knowledge
of the patient and the services needed to meet the goals of the
individualized home health plan of care. This would mean that the HHA
would consider the most appropriate and efficient use of home health
services based on patient needs. Therefore, therapy may be an important
service in any of the clinical groups; however, it may not necessarily
be the primary reason for home health care, which is what the clinical
group is intended to capture. Similarly, we expect that skilled
nursing, home health aide, and medical social services would likely be
included in the care plan for patients in the rehabilitation clinical
groups.
While implementing the use of safeguards to ensure comprehensive
evaluation of therapy needs is out of scope for this rule, we note that
the home health CoPs establish the health and safety standards for care
given to Medicare home health beneficiaries. As such, the CoPs would
include such safeguards such as the type and frequency of patient
assessments. Finally, section 1895(b)(4)(B)(ii) of the Act, as added by
section 51001 of the BBA of 2018 requires elimination of therapy
thresholds as part of the case-mix adjustment methodology, effective
for January 1, 2020.
Comment: Another commenter expressed concern with the lower
reimbursement assigned to the musculoskeletal rehabilitation clinical
group, stating that home health providers may not have the same
incentives to admit and treat these patients under PDGM. Another
commenter suggested the addition of a complex therapy clinical group.
Response: We believe that it is important to look at the entire
structure of the model, not only the clinical grouping, in order to
understand how a patient with different skilled therapy or nursing
needs are placed into a payment group. The clinical grouping is only
one step in establishing a home health payment for a period of care.
Again, this group is based on the principal diagnosis listed on the
claim as well as specific OASIS items that indicate the need for more
complex interventions that correlate with higher resource use. The
clinical group is intended to capture the main reason the patient is
receiving home health, but as we state in the CY 2019 HH PPS proposed
rule, we understand that not all care needs can be identified by a
diagnosis alone. Therefore, after the primary reason for the 30-day
period is captured by the clinical grouping, the PDGM then takes into
account the functional impairment level of the patient. Decreasing
functional status, as indicated by a specific set of OASIS items, is
associated with increased resource use. We believe that the functional
impairment level of patients, when combined with the clinical grouping,
would capture additional resource use from any multi-disciplinary
therapy patients, or patients with ``complex-therapy'' needs. For
instance, a patient grouped into the Neuro-Rehabilitation clinical
grouping with a high Functional Impairment Level indicates increased
therapy needs, potentially utilizing all skilled therapy disciplines.
Additionally, the comorbidity adjustment further case mixes the period
and increases payment to capture the additional resource use for a
patient regardless of whether the services are skilled nursing or
therapy based. Therefore, a patient with complex needs, including
multiple therapy services and medical management, is captured by the
combination of the different levels of the model. Furthermore, we note
that the current payment model does not differentiate between
utilization of therapy disciplines and whether or not all three therapy
disciplines are utilized for the same patient. We believe that the
PDGM's functional impairment level when combined with the clinical
grouping provides a much clearer picture of the patient's needs,
particularly in relation to therapy services.
Final Decision: We are finalizing, with modification, our approach
to grouping 30-day periods of care into clinical groups that represent
the primary reason for home health care. We are finalizing twelve
clinical groups, as shown in Table 27, which capture the most common
primary reasons for home health care. The additional groups are a
result of dividing the MMTA clinical group into 7 sub-groups. We note
that although we are categorizing patients into twelve groups according
to the principal diagnosis, these groups do not reflect all the care
being provided to the home health patient during a 30-day period of
care. Home health care remains a multidisciplinary benefit.
Additionally, as stated in the CY 2019 HH PPS proposed rule, we will
continue to examine trends in reporting and resource utilization to
determine if future changes to the clinical groupings are needed after
implementation of the PDGM in CY 2020.
[[Page 56477]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.033
7. Functional Impairment Levels and Corresponding OASIS Items
As part of the overall case-mix adjustment under the PDGM, we
proposed in the CY 2019 HH PPS proposed rule to include a functional
impairment adjustment to account for the resource costs associated with
providing home health care to those patients with functional
impairments. Research has shown a relationship exists between
functional status, rates of hospital readmission, and the overall costs
of health care services.\19\ Functional status is defined in a number
of ways, but generally, functional status reflects an individual's
ability to carry out activities of daily living (ADLs) and to
participate in various life situations and in society.\20\ CMS
currently requires the collection of data on functional status in home
health through a standardized assessment instrument: the Outcome and
Assessment Information Set (OASIS).
---------------------------------------------------------------------------
\19\ Burke, R. MD, MS, Whitfield, E. Ph.D., Hittle, D. Ph.D.,
Min, S. Ph.D., Levy,C. MD, Ph.D., Prochazka, A. MD, MS, Coleman, E.
MD, MPH, Schwartz, R.MD, Ginde, A. (2016). ``Hospital Readmission
From Post-Acute Care Facilities: Risk Factors, Timing, and
Outcomes''. The Journal of Post-Acute Care and Long Term Care
Medicine. (17), 249-255.
\20\ Clauser, S. Ph.D., and Arlene S. Bierman, M.D., M.S.
(2003). ``Significance of Functional Status Data for Payment and
Quality''. Health Care Financing Review. 24(3), 1-12.
---------------------------------------------------------------------------
Including functional status in the case-mix adjustment methodology
allows for higher payment for those patients with higher service needs.
As functional status is commonly used for risk adjustment in various
payment systems, including in the current HH PPS, we proposed that the
PDGM would also adjust payments based on responses to selected
functional OASIS items that have demonstrated higher resource use.
Generally, worsening functional status is associated with higher
resource use, indicating that the responses to functional OASIS items
may be useful as adjustors to construct case-mix weights for an
alternative case-mix adjustment methodology.
Each proposed OASIS item included in the PDGM has a positive
relationship with resource use, meaning as functional status declines
(as measured by a higher response category), home health periods have
more resource use, on average. In the CY 2019 HH PPS proposed rule, we
proposed that the following OASIS items would be included as part of
the functional impairment level adjustment under the PDGM:
M1800: Grooming.
M1810: Current Ability to Dress Upper Body.
M1820: Current Ability to Dress Lower Body.
M1830: Bathing.
M1840: Toilet Transferring.
M1850: Transferring.
M1860: Ambulation/Locomotion.
M1033 Risk of Hospitalization (at least four responses
checked, excluding responses #8, #9, and #10).\21\
---------------------------------------------------------------------------
\21\ Exclusions of the OASIS C-1 Item M1033 include, response
#8: ``currently reports exhaustion''; response #9: ``other risk(s)
not listed in 1-8; response #10: None of the above.
Due to the lack of variation in resource use across certain responses
and because certain responses were infrequently chosen, we combined
some responses into larger response categories to better capture the
relationship between worsening functional status and resource use. The
resulting combinations of responses for the OASIS items previously
discussed are found at Exhibit 7-2 in the technical report, ``Overview
of the Home Health Groupings Model,'' on the HHA Center web page.\22\
---------------------------------------------------------------------------
\22\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------
Under the PDGM, a home health period of care receives points based
on each of the responses associated with
[[Page 56478]]
the proposed functional OASIS items which are then converted into a
table of points corresponding to increased resource use. That is, the
higher the points, the higher the functional impairment. The sum of all
of these points' results in a functional impairment score which is used
to group home health periods into a functional level with similar
resource use. We proposed three functional impairment levels of low,
medium, and high with approximately one-third of home health periods
from each of the clinical groups within each level. This means home
health periods in the low impairment level have responses for the
proposed functional OASIS items that are associated with the lowest
resource use on average. Home health periods in the high impairment
level have responses for the proposed functional OASIS items that are
associated with the highest resource use on average. We also proposed
that the functional impairment level thresholds would vary between the
clinical groups to account for the patient characteristics within each
clinical group associated with increased resource costs affected by
functional impairment. In the CY 2019 HH PPS proposed rule, we also
discussed the potential, future inclusion of the IMPACT Act section GG
functional items, which will be collected on the OASIS starting January
1, 2019. A detailed analysis of the development of the functional
points and the functional impairment level thresholds by clinical group
can be found in the technical report on the HHA Center web page.
As noted in section III.F.6 of this final rule with comment period,
we are subdividing the MMTA clinical group into seven sub-groups (MMTA-
aftercare; cardiac/circulatory; endocrine; gastrointestinal/
genitourinary; infectious disease/neoplasms/blood-forming diseases;
respiratory; and other) to more accurately capture unique patient
characteristics associated with patients receiving home health services
for medication management, teaching, and assessment. As such, we
recalculated the functional points and the thresholds for the
functional impairment levels by clinical group. This also resulted in a
few minor changes to the functional thresholds compared to the
thresholds in the CY 2019 HH PPS proposed rule (Table 42, 83 FR 32406).
The updated OASIS points table for the functional items and the table
of functional impairment level thresholds for by clinical group are
found in Tables 28 and 29.
[GRAPHIC] [TIFF OMITTED] TR13NO18.034
[[Page 56479]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.035
In the CY 2019 HH PPS proposed rule, we solicited comments on the
proposed functional OASIS items, the associated points, and the
thresholds by clinical group used to group patients into three
functional impairment levels under the PDGM, as previously outlined.
The majority of comments received were very similar to those received
on the alternate case-mix adjustment methodology (HHGM), in the CY 2018
HH PPS proposed rule. The comments received are summarized in this
section.
Comment: Most commenters agreed that the level of functional
impairment should be included as part of the overall case-mix
adjustment in a revised case-mix model. Commenters stated that
including a robust functional level variable in the home health payment
system will eliminate the incentive to provide unnecessary therapy
services to reach higher classifications for payment but will also move
the HH PPS toward greater consistency with other post-acute care PPS.
Response: We thank commenters for their careful review of all
variables contributing to the overall case-mix adjustment in the PDGM.
We agree that functional status is an important component in
understanding patient characteristics to help facilitate the
development of an individualized home health plan of care based on
identified needs and to help ensure that payment
[[Page 56480]]
is in alignment with the costs of providing care.
Comment: Several commenters supported the examination and possible
inclusion of the IMPACT Act's section GG, Functional Abilities and
Goals, as part of the functional level case-mix adjustment in the PDGM.
A commenter remarked that by adding the section GG functional items to
the HH VBP model and the HH QRP, CMS would be able to better monitor
provider behavior to detect inappropriate responses to implementation
of the PDGM, including withholding therapy services that could result
in poor outcomes; selecting patients who are likely to be relatively
more profitable; generating unnecessary periods of care; or prematurely
discharging patients. However, a few commenters recommended that CMS
study and validate the predictive capability of such items prior to
pursuing any refinements to the PDGM's functional level category. This
commenter remarked that it is critical that CMS is confident in the
capability of Section GG functional items to sufficiently predict
functional impairment level and associated resource use.
Response: We appreciate the commenter feedback on the potential use
of the GG functional items as part of the functional impairment level
case-mix adjustment in the PDGM. We remind commenters that because
these GG functional items are not required to be collected on the OASIS
until January 1, 2019, we do not have the data at this time to
determine the effect, if any, of these newly added items on resource
costs during a home health period of care. Therefore, the GG functional
items would not be used immediately upon implementation of the PDGM in
CY 2020. We will continue to analyze all OASIS items, including the
newly added GG functional items, after the implementation of the PDGM,
to determine if the data supports any refinements to the case-mix
adjustments. The goal is to keep only those items that are reliable,
validated, have an impact on resource utilization, and address quality
outcomes in order to ultimately decrease the number of OASIS items and
reduce burden. Likewise, while the GG functional items may be able to
play an important role in the HHVBP Model and HH QRP in monitoring for
quality outcomes, their consideration for use in the PDGM would be to
identify their relationship to resource utilization to more accurately
align payment with home health costs.
Comment: Commenters stated that the functional impairment level
thresholds do not fully capture the functional impairments that
translate to the actual resources needed on the home health plan of
care. Many commenters believe that the functional impairment level
adjustment is relatively small and inadequate to reimburse for patients
with chronic care needs potentially creating access issues for people
who are chronically ill and may require a prolonged period of home
health care. Many commenters remarked that HHAs would not admit these
types of patients or would cut back on the number of therapy visits
provided, especially now that therapy thresholds will be removed in CY
2020. Several commenters stated that the PDGM favors only patients who
are expected to improve and not those who require ongoing, maintenance
therapy but do not group into one of the predominantly therapy groups
and therefore is counter to the provisions in the Jimmo Settlement
Agreement.
Response: We believe that the functional impairment level
adjustment would adequately capture the level of functional impairment
based on patient characteristics reported on the OASIS. The PDGM not
only uses the same five OASIS items used in the current HH PPS to
determine the functional case-mix adjustment (M1810, M1820, M1830,
M1830, M1850, and M1860), but adds two additional OASIS items (M1800
and M1033) to determine the level of functional impairment. The
structure of categorizing functional impairment into Low, Medium, and
High levels has been part of the home health payment structure since
the implementation of the HH PPS. The current HH PPS groups home health
episodes using functional scores based on functional OASIS items with
similar average resource use within the same functional level, with
approximately a third of episodes classified as low functional score, a
third of episodes are classified as medium functional score, and a
third of episodes are classified as high functional score. Likewise,
the PDGM groups' home health periods of care using functional
impairment scores based on functional OASIS items with similar resource
use and has three levels of functional severity: low, medium and high.
However, the PDGM differs from the current HH PPS functional variable
in that the three functional impairment level thresholds in the PDGM
vary between the clinical groups. The PDGM functional impairment level
structure accounts for the patient characteristics within that clinical
group associated with increased resource costs affected by functional
impairment. This is to further ensure that payment is more accurately
aligned with actual patient characteristics and resource needs. As
such, we believe the more granular structure of these functional levels
provides the information needed on functional impairment and allows
greater flexibility for therapists to tailor a more patient-centered
home health plan of care to meet the individualized needs of their
patients.
We disagree that the functional impairment level case-mix payment
adjustment is inadequate and that the PDGM would inhibit access to care
for those with patients with complex and/or chronic care needs and high
functional impairments. The absence of discipline-related therapy
thresholds allows for a more equitable distribution of services based
on patient needs, including needs for chronically ill patients. We note
that the PDGM is structured to capture patient characteristics,
including functional impairment status, similar to the functional case-
mix adjustment in the current HH PPS. As HHA-reported OASIS information
determines the payment amounts for each of the functional levels,
accurate reporting on the OASIS by HHAs will help to ensure that the
case-mix adjustment is in alignment with the actual level of functional
impairment.
We also disagree with the comment that the PDGM favors only those
home health patients who are expected to improve, does not take into
account patients with longer term maintenance therapy needs, and is
counter to the provisions of the Jimmo Settlement Agreement. We remind
commenters that the structure of the home health benefit requires a
multidisciplinary approach, and the PDGM promotes the provision of not
only therapy services, but skilled nursing, home health aide, and
medical social services as well. The clinical groups, as well as the
functional impairment level case-mix adjustment, account for the full
range of services available under the Medicare home health benefit. We
believe that the functional impairment level adjustment compensates for
the resource needs of those with functional impairment and ongoing
therapy needs, and therefore does not endorse one type of patient over
another. There has never been an expectation that only patients who
demonstrate the ability to improve are eligible for the Medicare home
health benefit. We have educated the MACs extensively to ensure that
any medical review of claims for cognitively or functionally impaired
patients who are receiving maintenance therapy to prevent further
deterioration, are doing
[[Page 56481]]
so according to the parameters within the Jimmo Settlement Agreement.
We believe adding a more robust and granular functional impairment
level adjustment should preserve, and potentially increase access to
therapy services for vulnerable patients who may not otherwise have
received needed therapy services, including those with complex and/or
chronic care needs. As such, we would expect continued admissions of
these patient populations with therapy visits provided in accordance
with physician orders as documented on the plan of care, including the
frequency and duration of these orders. We remind HHAs that the PDGM
case-mix adjusters work in tandem to reflect a patient's 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.
The PDGM is not limiting or prohibiting the provision of therapy
services or the number of home health periods of care, nor is there a
reduction to the overall base rate of home health payment. The
commenters imply that HHAs would ``cherry pick'' the type of patients
to admit primarily based on Medicare payment under the PDGM and that
care decisions, including the number of therapy visits, are determined
solely on profitability of patients. As such, any potential access
issues would be the result of a change in HHA behavior in response to
the removal of therapy thresholds to maximize margins of a bundled
payment rather than the result of a case-mix adjustment model that
seeks to more accurately pay for home health services. Manipulating
visit patterns, including the type and number of visits provided, and/
or admitting only certain patient populations to maximize payment is
counter to the purpose of a prospective payment system and the intent
of a patient-driven Medicare home health benefit. Furthermore, this
could result in a violation of the home health CoPs and may signal
program integrity issues. We will continue to monitor the impact of all
of the case-mix adjustments in the PDGM to determine if any changes to
utilization are occurring, especially as they relate to the provision
of therapy. This may involve, but is not limited to, comparative
analysis of utilization patterns prior to and after the implementation
of the PDGM and could result in additional enforcement actions as a
result of any program integrity concerns. Likewise, the BBA of 2018
requires that we calculate the 30-day budget-neutral payment amount
based on assumed behavior changes resulting from the implementation of
a 30-day unit of payment and the PDGM. The law also requires that we
annually analyze the impact of differences between the assumed and
actual behavioral changes on estimated aggregate expenditures for CYs
2020 through 2026 and to make any payment amount adjustments, either
upwards or downwards, accordingly.
Comment: Some commenters remarked that the PDGM diminishes and
devalues the role physical, occupational, and speech language pathology
therapists play in quality outcomes by alleviating risks of increased
falls, emergency room visits, re-hospitalizations, improving or
maintaining functional level, and keeping patients in their homes.
Other commenters stated that minimization of the importance of the home
health therapy disciplines would cause therapists to lose their jobs in
home health. Commenters said that access to home therapy will be
significantly curtailed as a result and functional outcomes would be
negatively impacted. These commenters remarked that the PDGM appears to
be counter to the Triple Aim: improving the patient experience of care
(including quality and satisfaction); improving the health of
populations; and reducing the per capita cost of health care.
Response: We disagree that the PDGM diminishes or devalues the
clinical importance of therapy. The musculoskeletal and neurological
rehabilitation groups under the PDGM recognize the unique needs of
patients with musculoskeletal or neurological conditions who require
therapy as the primary reason for home health services. For the other
clinical groups, we note that the 30-day base payment amount includes
therapy services, even if the primary reason for home health is not for
the provision of therapy. The functional impairment level adjustment in
conjunction with the other case-mix adjusters under the PDGM, aligns
payment with the costs of providing services, including therapy.
We agree with commenters that the role of the physical,
occupational, and speech language pathology therapists is important in
quality outcomes and the prevention of adverse events, such as falls
and emergency room visits, and that these disciplines are important in
helping patients remain in their own homes. However, we note that the
goal of the PDGM is to provide appropriate payment based on the
identified resource use of different patient groups; not to encourage,
discourage, value, devalue, or promote one type of skilled care over
another.
We do not expect HHAs to make personnel decisions solely based on a
change to the HH PPS case-mix methodology as the requirements for
providing home health services have not been changed. Under the
Medicare home health benefit, skilled professional services include
skilled nursing services, physical therapy, speech-language pathology
services, and occupational therapy, as specified in Sec. 409.44, and
dependent services include home health aide services and medical social
work services, as specified in Sec. 409.45. Skilled professionals who
provide services to HHA patients directly or under arrangement must
participate in the coordination of care. Additionally, we note that the
home health CoPs at Sec. 484.60 require that each patient receive an
individualized written plan of care that 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).
Concerns regarding HHAs changing the way they provide services to
eligible beneficiaries, specifically therapy services, should be
mitigated by the more granular functional impairment level adjustment
(for example, functional thresholds which vary between each of the
clinical groups). The functional impairment level case-mix adjustment
is reflective of the resource costs associated with the reported OASIS
items and therefore ensures greater payment accuracy based on patient
characteristics. We believe that this approach will help to maintain
and could potentially increase access to needed therapy services. We
remind HHAs that the provision of home health services should be based
on patient characteristics and identified care needs. This could
include those patients with complex and/or chronic care needs, or those
patients requiring home health services over a longer period of time or
for which there is no measureable or expected improvement.
Finally, we believe that the PDGM is in alignment with the tenants
of the CMS Triple Aim to provide better care for individuals; promote
better health outcomes for populations; and lower health care costs.
The PDGM does so by taking a patient-driven approach over a volume-
based approach by using patient characteristics, rather than arbitrary
thresholds of visits that do not necessarily equate to better outcomes
or
[[Page 56482]]
lower costs. The PDGM seeks to better define the services needed by
home health beneficiaries. We believe that developing a case-mix system
that provides a clearer picture as to the services provided under the
Medicare home health benefit can help promote efficiencies in achieving
desired patient outcomes.
Comment: Several commenters expressed concern over how CMS would
ensure that necessary therapy visits are provided to home heath
beneficiaries. These commenters remarked that it is unclear how CMS
intends to capture an accurate assessment of the services delivered
during the home health period of care, particularly physical therapy,
occupational therapy, and/or speech-language pathology services. Other
comments stated that they fail to see how medical review is a
sufficient option to remedy the consequences associated with delivering
inadequate care, as they said that medical review does nothing that
would allow care delivery to be modified during the period of care. A
few commenters urged CMS to use ``accountability mechanisms,'' such as
medical review, and recommended that the agency analyze the medical
review findings and publically report any observed patient care trends
via Home Health Compare.
Response: The purpose of the changes to the case-mix adjustment
methodology is to more accurately align home health payments with the
costs of providing care. Other accountability mechanisms, such as
survey and certification of HHAs, are the most appropriate ways to
ensure quality and safety for Medicare home health recipients. Quality
is also determined through other mechanisms, such as the HH QRP and the
HHVBP Model.
The new home health CoPs are more detailed in the expectations of
the provision of needed home health services. Specifically, the CoPs at
Sec. 484.60 require that patients are accepted for treatment on the
reasonable expectation that an HHA can meet the patient's medical,
nursing, rehabilitative, and social needs in his or her place of
residence. Services are required to be identified in an individualized
written plan of care, including any revisions or additions. 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.
It is difficult to proactively determine that care is
``inadequate'' or ``of poor quality'' given that we do not know the
type, frequency or quality of services until after those services are
provided. The volume of services provided does not necessarily equate
with higher quality of care.
We believe that the home health CoPs provide the requirements to
promote and ensure quality home health care. However, as we indicated
in the CY 2019 HH PPS proposed rule, we will continue to analyze
utilization trends, including therapy visits as reported on home health
claims, to identify any issues that may warrant any quality or program
integrity intervention.
Comment: Some commenters expressed concerns that Medicare
beneficiaries' functional outcomes may significantly decline following
PDGM implementation because the provision of therapy services would be
reduced without the extra payment for increased therapy services. These
commenters stated that research has shown a significant correlation
between volume of therapy and improvement in outcomes. Some commenters
stated adoption of the PDGM could reverse the progress in patient
outcomes that was seemingly ignited by a ``financial incentive'' to
increase therapy visits versus skilled nursing visits.
Response: We disagree that patients' functional outcomes would
significantly decline following PDGM implementation. We reference a
study conducted by RAND contrasting the effects of two payment reforms
for home health agencies, specifically comparing the Interim
Prospective Payment System (IPS) and the Prospective Payment System
(PPS). This study did not show worsening patient outcomes (that is,
increased hospitalizations or mortality) when there was a transition
from one payment system to another (that is, from the IPS to the PPS).
In this particular study, the analysis also showed both payment reforms
had limited effects on costs in other post-acute settings, and limited
effects on patient outcomes as the study noted that there was not any
substantial increase in hospital readmissions or patient mortality
after the implementation of the PPS.\23\ Furthermore, in its March,
2010 report, MedPAC stated that higher home health spending is not
yielding better outcomes. In this report, MedPAC stated that
undesirable outcomes (for example, unnecessary complications) may
result in additional payments, and sectors with more than adequate
payments may have little incentive to improve quality.\24\
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\23\ Huckfeldt, P., Sooda, N., Escarcea, J., Grabowski, D.,
Newhouse, J. Effects of Medicare payment reform: Evidence from the
home health interim and prospective payment systems. Journal of
Health Economics (34) 1-18. March, 2014. https://doi.org/10.1016/j.jhealeco.2013.11.005.
\24\ http://www.medpac.gov/docs/default-source/reports/Mar10_EntireReport.pdf.
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We believe that the structure of the PDGM is more patient-driven
than the current case-mix system and more accurately represents the
patient characteristics that will correspond to an appropriate
individualized care plan to provide those needed services. We believe
that the PDGM will allow for more tailored, appropriate quality of care
and removes the financial incentive to focus on the volume of care and
not patient needs. By keeping patient characteristics at the center of
the case-mix adjustment methodology, we believe that patient needs will
be more accurately addressed and that this has the potential to result
in care plan goal achievement and desired patient outcomes.
Comment: Another commenter remarked that using the term
``Functional Level'' with a score of low-medium-high is confusing. This
commenter stated that this will confuse providers into believing the
reference is to low, medium, or high functional level. It would be
clearer to refer to this measure as a ``Functional Impairment Level''
in which case a low, medium, or high functional impairment would be
properly indicated.
Response: As explained in the CY 2019 HH PPS proposed rule, a home
health period of care receives points based on each of the responses
associated with the proposed functional OASIS items which are then
converted into a table of points corresponding to increased resource
use. That is, the higher the points, the higher the functional
impairment. As such, we agree that adding the term ``impairment'' when
referring to the functional level adjustment is appropriate.
Comment: A few commenters stated that the PDGM case-mix variables,
including the functional impairment level adjustment would make it more
difficult to manage costs and revenues for patients with high
functional impairments. Some commenters disagreed with the removal of
therapy thresholds as they asserted that the increased payments with
the thresholds allowed for the provision of adequate therapy services.
These commenters indicated that the reductions in payment for therapy
visits would result
[[Page 56483]]
in a decrease in HHA viability and would force many HHAs to go out of
business.
Response: We remind commenters that the removal of therapy
thresholds for CY 2020 and subsequent years is required by section
1895(b)(4)(B)(ii) of the Act, as added by section 51001 of the BBA of
2018, and therefore we are statutorily mandated to exclude therapy
thresholds in the development of an alternate case-mix adjustment
methodology effective January 1, 2020. We note that since 2000, under
the Medicare home health benefit, HHAs receive a bundled payment for
the provision of care to include skilled nursing; physical,
occupational, and speech-language pathology therapy; medical social
work; home health aides; and medical supplies. Under the PDGM, home
health payments remain prospective payments similar to the current
payment system, meaning an overall national, standardized base rate
with case-mix adjustments. The structure of a prospective payment
system is such that payment is based on a predetermined base rate
regardless of the volume, frequency, or intensity of the actual
service(s) provided. The case-mix adjustments provide additional
payment to account for patient characteristics. As such, the overall
payment amount is known to the HHA at the beginning of each home health
episode and this fixed home health rate necessitates better management
and estimation of costs and payments, and helps to motivate providers
to be more efficient in the provision of quality care. Therefore, a
home health bundled payment allows HHAs the discretion to allocate
resources based on their knowledge of the patient and the services
needed to meet the goals of the individualized home health plan of
care. This would mean that the HHA would consider the most appropriate
and efficient use of home health services based on patient needs. A
bundled payment reduces the uncertainty in payment, affording the HHA
more information to help manage revenues and costs in order to allocate
resources accordingly.
Additionally, the Medicare home health benefit requires a
multidisciplinary approach to care and the expectation is that HHAs
provide the full range of services under the benefit to all eligible
beneficiaries, and not solely therapy services. As such, developing a
business model designed to target only those patients requiring therapy
in order to maximize Medicare payment is counter to the requirements
under the benefit. It also places the HHA at financial risk if payment
is reliant only on a specific patient population. For those HHAs who do
provide the full range of services and do not target only those
patients for whom they can maximize payment based on therapy
thresholds, we believe that the functional impairment level adjustment
provides sufficient additional payment across all clinical groups. This
would include those patients who are receiving home health services
primarily for other skilled needs but who may also require therapy
services as part of their home health plan of care. The PDGM is
clinically-based, meaning it relies more heavily on patient
characteristics to place home health periods of care into clinically
meaningful payment categories. These patient characteristics also help
home health clinicians differentiate between the services needed by
home health patients. We believe that a patient-driven approach to
case-mix adjusting payment better clarifies the services provided under
the Medicare home health benefit. Therefore, we believe this patient-
driven approach better promotes efficiencies in the provision of care
based on actual patient needs and will make it easier for HHAs to
manage revenues and costs.
Finally, to support HHAs in evaluating the effects of the proposed
PDGM, CMS is providing, upon request, a Home Health Claims-OASIS
Limited Data Set (LDS).\25\ Additionally, CMS has posted an interactive
PDGM Grouper Tool on the HHA Center web page that will allow HHAs to
determine case-mix weights for their patient populations.\26\
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\25\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-_NewLDS.html.
\26\ https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.html.
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Comment: Several commenters stated that inclusion of caregiver
availability and support should be part of the functional level payment
adjustment in the PDGM because they report that a lack of caregiver
support plays a significant role in a patient's overall functional
level and resource needs especially as they relate to ADLs and IADLs.
Another commenter remarked that research has shown non-compliance and
readmission risk is higher when other psychosocial factors are present.
Several commenters recommended that the functional level include OASIS
items related to social determinants of health, such as those
associated with caregiver support.
Response: We understand the value of caregiver support for home
health patients and its potential to affect resource utilization and
the inclusion of caregiver variables has been examined several times
since the development of the current HH PPS. As explained in the FY
2001 HH PPS final rule (65 FR 41145), we examined the usefulness of
caregiver factors but found them to be only minimally helpful in
explaining or predicting resource use. We found that variables on the
availability of a caregiver had no impact on average resource cost and
only a modest impact after controlling for other patient
characteristics. We stated that we recognized that adjusting payment in
response to the presence or absence of a caregiver may be seen as
inequitable by patients and their families. To the extent the
availability of caregiver services, particularly privately paid
services, reflects socioeconomic status differences, reducing payment
for patients who have caregiver assistance may be particularly
sensitive. Furthermore, adjusting payment for caregiver factors may
introduce new and negative incentives into family and patient behavior.
It is questionable whether Medicare should adopt a payment policy that
could weaken informal familial supports currently benefiting patients
at times when they are most vulnerable (65 FR 41145). Similarly, when
we re-examined caregiver assistance as a potential case-mix variable in
the CY 2008 HH PPS proposed rule to analyze the payment adequacy of the
current four-equation model, we found that for patients without a
caregiver, on average, episodes would be ``underpaid'' (72 FR 25361).
However, the score to be gained by adding the variable was not large
and the overall ability of the four-equation model to explain resource
costs was improved only minimally by adding this variable. As such, we
did not propose that a caregiver variable be added to the case-mix
model at that time.
When we re-examined the OASIS caregiver items for possible
inclusion in the functional impairment level case-mix adjustment in the
PDGM, we found inverse patterns in resource use (82 FR 35319). We
examined OASIS items associated with types and sources of caregiver
assistance and frequency of ADL/IADL assistance. These items assess the
ability and willingness of non-agency caregivers (such as family
members, friends, or privately paid caregivers) to provide categories
of assistance needed by the patient, including ADL/IADL assistance,
medication administration, and management of equipment. As responses to
these items generally are not based on direct observation by the
clinician conducting the assessment,
[[Page 56484]]
this presents a limitation for use in a case-mix adjustment as the
accuracy of the responses cannot be easily validated. Patients or
caregivers may overestimate or underestimate their ability or
willingness to assist in the patient's care. Likewise, analysis of
these items generally showed that an increased need for assistance had
a negative impact on resource costs, meaning that as need for
assistance increased, costs decreased. We believe this is clinically
counterintuitive and, as outlined in both the Medicare Home Health
Prospective Payment System: Case-Mix Methodology Refinements Overview
of the Home Health Groupings Model technical report \27\ and the CY
2018 and CY 2019 HH PPS proposed rules (82 FR 35270 and 83 FR 32340),
we excluded any OASIS items that had a negative relationship with
resource costs. Including these items would only serve to reduce the
home health period of care payment. As such, the current data analysis
findings we conducted on caregiver variables weaken the assertion that
failure to adjust for caregiver factors could render payments
inadequate.
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\27\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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Finally, we continue to believe that including this kind of
variable in the case-mix system raises significant policy concerns. We
maintain that a case-mix adjustment should not discourage assistance
from family members of home care patients, nor should it make patients
believe there is some financial stake in how they report their familial
supports during their convalescence. We have concerns that adjusting
payment in response to the absence of a caregiver would introduce
negative incentives with adverse effects on home health Medicare
beneficiaries.
Comment: Several commenters recommended that cognition, pain and
dyspnea should be included as functional level determinants as they
affect functional performance and trajectory for improvement. Many
commenters supported the inclusion of cognitive items as part of the
functional case-mix adjustment, and noted that there is a correlation
between cognitive status and functional impairment. A few commenters
suggested that OASIS item M1242, Frequency of Pain interfering with
Activity, should be included as part of the functional level items in
the PDGM. These commenters stated that pain directly impacts functional
performance. These same commenters remarked that PT and OT can directly
reduce pain thus improving the patient's quality of life.
Response: The current HH PPS does not use OASIS items associated
with IADLs or cognition. We agree with commenters that the relationship
between cognition and functional status is important and well-
documented in health care literature. We discussed our analysis and
rationale for evaluating all of the OASIS items related to function,
including the relationship between cognitive functioning and resource
use, extensively in both the technical report \28\ and the CYs 2018 and
2019 HH PPS proposed rules (82 FR 35319, 83 FR 32404). Empirically, it
appears that cognition does impact functionality, and initially these
items were included in the PDGM. Counterintuitively, however, resource
use declined as cognitive status worsened. This negative relationship
with resource use was consistent throughout all levels of cognitive
functioning as assessed on the OASIS, including mild impairment. While
we cannot explain this phenomenon from OASIS or home health claims
alone, anecdotally we have heard that while cognitive impairment may
intuitively signal increased resource use, the cognitive items are not
currently payment items and therefore do not receive the same attention
as the payment items when completing the OASIS. Likewise, we have
received reports that as cognition declines, individuals often become
more dependent on caregivers for functional tasks and thus the home
health clinician is not performing those tasks during a visit. We
frequently hear from clinicians that as it becomes increasingly
difficult to teach the cognitively impaired patient how to perform
ADLs/IADLs, teaching the caregiver to perform the functional tasks is
more efficient or beneficial. Additionally, we have been told it that
generally takes more time to teach and train the cognitively impaired
patient to perform a functional task so the clinician may simply
perform the functional task him or herself as the patient's ability to
independently perform these tasks progressively declines. All of these
anecdotes potentially could explain the inverse relationship between
cognitive impairment and resource use.
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\28\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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As discussed previously, the OASIS cognitive items are not used for
a payment adjustment under the current HH PPS, but most of the proposed
functional items are. As commenters have stated, there is potentially
more HHA focus on the OASIS payment items, which could explain why the
functional items show a positive relationship to resource use while the
cognitive items do not. As many commenters have stated and as supported
in the research, there is a relationship between cognition and
functional status. As such, we believe that the functional items
included in the functional impairment level case-mix adjustment provide
a reasonable proxy for cognitive status given their interrelatedness.
Because of the negative relationship between the OASIS cognitive items
and resource use, we decided not to include the items as part of the
functional adjustment in the PDGM but will continue to analyze their
inclusion once the PDGM is implemented.
Similarly, we also examined pain and dyspnea OASIS items for
inclusion in the case-mix adjustment methodology including OASIS items
M1242, Pain and M1400, Shortness of Breath. While M1242, Pain, is used
in the current HH PPS, this was shown to have only a minimal
relationship with resource use in the current payment model.
Additionally, we believe that this one item alone may not be robust
enough to fully capture the pain presentation of the patient and its
impact on resource utilization and therefore it was dropped from
consideration. While M1400, Shortness of Breath, is also used in the
current HH PPS, it too shows minimal impact on resource use. We did not
include M1400 in the PDGM case-mix adjustment methodology because we
believe the more granular ICD-10 codes that describe respiratory
conditions, more accurately capture this patient characteristic. Again,
we refer commenters to the more detailed discussion on why certain
OASIS items were included or excluded from the model, the ``Overview of
the Home Health Groupings Model Technical Report'' \29\ and the CY 2018
HH PPS proposed rule (82 FR 35307).
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\29\ ``Overview of the Home Health Groupings Model'' technical
report, Appendix Exhibit A7-1 on the HHA Center web page (https://ww.com.gov/center/provider-type/home-health-agency-hha-center.html).
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Comment: The majority of commenters agreed that the elimination of
therapy thresholds is appropriate because of the current financial
incentive to overprovide therapy services. However, these commenters
believe that the functional impairment level adjustment is not an
adequate proxy to ensure the provision of therapy services needed for
patients requiring multiple disciplines of therapy or the frail elderly
with multiple chronic conditions and associated functional impairment.
A few commenters questioned whether CMS has evidence
[[Page 56485]]
that Medicare beneficiaries have received ``too much'' therapy, or that
the functional outcomes of Medicare beneficiaries receiving home health
services have suffered, under the current payment system. These
commenters stated that given the ever-increasing effort to promote the
delivery of care in the home and community settings, it is imperative
that the Medicare program continue to incentivize providers to deliver
care in non-facility-based settings while also ensuring that patients
may continue to receive the highest quality of care that aligns with
their preferences, desires, and needs.
Response: We agree that the therapy thresholds have created an
incentive to overprovide therapy services that are not in alignment
with patient characteristics and care needs. Section 1895(b)(4)(B)(ii),
as added by section 51001 of the BBA of 2018, requires that CMS
eliminate the use of therapy thresholds as part of the case-mix
adjustment methodology beginning in CY 2020. We note that the purpose
of the functional impairment level case-mix adjustment is not meant to
act as a direct proxy to replace the current therapy thresholds. As
noted, the presence of the therapy thresholds provided an incentive to
overprovide services and their removal deflates that financial
incentive to help ensure that therapy services are based on actual
patient needs. However, we recognized that in order to account for
levels of functional impairment and to help ensure that necessary
therapy services are provided, the development of a functional
impairment level case-mix adjustment with more granularity was
necessary. We believe that the three PDGM functional impairment levels
in each of the 12 clinical groups are designed to encourage therapists
to determine the appropriate services for their patients in accordance
with identified needs rather than an arbitrary threshold of visits.
The PDGM has other case-mix adjustments in addition to the
functional impairment level 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.
To address comments about evidence regarding ``too much'' therapy,
we remind commenters that analysis has repeatedly shown that the
current HH PPS therapy thresholds promote the provision of care based
on increased payment associated with each of these thresholds as
opposed to actual patient needs. In the CY 2018 HH PPS proposed rule,
analysis of home health claims shows that the average episode payment
by the number of therapy visits for episodes with at least one therapy
visit increases sharply just over payment thresholds at 6, 7, and 16
(82 FR 35276).
Furthermore, CMS analysis demonstrates that the average share of
therapy visits across all 60-day episodes of care increased from 9
percent of all visits in 1997, prior to the implementation of the HH
PPS (see 64 FR 58151), to 39 percent of all visits in 2015 (82 FR
35276). We note that the therapy thresholds have been widely criticized
by MedPAC who has recommended the removal of therapy thresholds for the
past 5 years, as their analysis has repeatedly shown that Medicare
payments for home health services have substantially exceeded costs.
Additionally, the Senate Committee on Finance conducted an
investigation and issued a report on therapy practices of four of the
largest publically-traded home health agencies where three out of the
four companies investigated encouraged therapists to target the most
profitable number of therapy visits, even when patient need alone may
not have justified such patterns. The Senate investigation also
highlighted the abrupt and dramatic responses the home health industry
has taken to maximize payment under the therapy threshold models (both
the original 10-visit threshold model and under the revised thresholds
implemented in the CY 2008 HH PPS final rule (72 FR 49762)). The report
noted that, under the current HH PPS, HHAs have broad discretion over
the number of therapy visits provided, and therefore have control of
the single-largest variable in determining reimbursement and overall
margins. The report recommended that CMS closely examine a future
payment approach that focuses on patient wellbeing and health
characteristics, rather than the numerical utilization measures.
We agree that most patients would prefer to receive services in
their own home whenever feasible and the Medicare home health benefit
affords a comprehensive range of services for eligible beneficiaries.
However, we are cognizant that payment may affect practice patterns and
our analysis has shown that visits vary in response to financial
incentives. While the goal of the PDGM case-mix adjustments is to align
payment with actual patient characteristics, we are aware that practice
patterns may shift upon implementation of a new case-mix methodology.
Our goal is to protect patient choice and preferences as well as
promote the provision of high quality, appropriate home care. As we
have reiterated throughout this final rule with comment period, upon
implementation of the PDGM, we will continue to examine the impact of
all OASIS items on resource costs. Likewise, we will also examine any
changes in the number of therapy visits provided that could indicate
HHAs stinting on needed therapy services to determine whether any
impacts warrant additional refinements to the case-mix adjustments
under the PDGM.
Comment: Some commenters expressed concern that eliminating the
therapy thresholds, which dominate the current HH PPS, would cause the
unintended consequence of shifting patients to other home health
disciplines, specifically nursing and home health aides, which would
steer patients away from restorative therapies and ultimately increase
Medicare costs. Some expressed concern about other disciplines
providing therapy services outside of the scope of their practice. Some
expressed reservations about possible misuse of aides to provide what
should be skilled therapy, such as providing exercise programs or
evaluating self-care needs and safety as a substitute for skilled
therapy. These commenters state that both substitutions are
inappropriate and may violate state licensure law, for example, the
provision of therapy services by unqualified personnel.
Response: Regarding the comment that the removal of therapy
thresholds would shift patients to other home health disciplines, we
note that in the CY 2001 HH PPS final rule, we expressed concern over
using a therapy utilization measure to determine home health payment
because it could be susceptible to manipulation and may cause a shift
away from home health nursing and other services. In this same rule,
commenters expressed concern that implementing a therapy threshold
would divert utilization of the home health benefit away from the frail
elderly and in favor of the short-term patient (65 FR 41149). These
concerns about the impact of the introduction of the therapy thresholds
are the same concerns now expressed by commenters regarding the impact
of the elimination of the therapy thresholds. In the CY 2001 rule, we
stated that we would continue to review the use of a utilization
variable in the payment
[[Page 56486]]
system over the long-term. As discussed previously in this section,
there was a noted shift to increased therapy services after the
implementation of the HH PPS with the therapy thresholds. We believe
that the elimination of the therapy thresholds will remove the
financial incentive to provide therapy solely for increased payment. As
we are not adding any service utilization measure for nursing or home
health aides, this would mitigate the financial incentive to provide
more of those services solely for increased payment as well.
Essentially, this would mean that no one home health discipline is
favored or paid differently than any other discipline within the home
health bundled payment and the plan of care would be patient-centered
as opposed to payment-centered. 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, and substituting a
home health aide to provide those skilled therapy services would be a
violation of the CoPs (42 CFR 484.32).
We note that the goal of the PDGM is to provide appropriate payment
based on the identified resource use of different patient groups; not
to encourage, discourage, value, devalue, or promote one type of
skilled care over another. Because there are no service utilization
thresholds in the PDGM, we expect that HHAs will respond by adapting a
business model based on more patient-centered care as opposed to
payment-driven care.
Comment: Several commenters stated that the PDGM would reward
inefficiency but not high quality outcomes by redistributing payments
away from services such as physical, occupational and speech therapy.
They remarked that this shift would make it harder for patients with
high functional impairment to achieve quality outcomes.
Response: The intent of the PDGM is to more accurately apportion
payment with the costs of providing care. We disagree that the
redistribution of payments would reward inefficiency as the home health
agency is already tasked with developing efficiencies within the
current home health bundled payment. Additionally, the home health
quality reporting program (HH QRP), and the HH VBP Model contain
outcome measures which are used, respectively, for the Home Health star
ratings and a total performance score used to tie payments to quality
performance for HHAs in certain states. As such, we believe that both
the HH QRP and the HH VBP Model help to promote and ensure quality
outcomes, whereas the PDGM is the mechanism for payment for services
provided. Furthermore, regardless of level of functional impairment, we
expect that HHAs always strive for efficiency and high quality outcomes
for their patients. This is achieved through the appropriate provision
of services in accordance with patient characteristics and physician
orders as documented on the home health plan of care.
Final Decision: After review of public comments, we are finalizing
the use of OASIS items: M1800, M1810, M1820, M1830, M1840, M1850, M1860
and M1033 for the functional impairment level case-mix adjustment under
the PDGM. We are finalizing that a home health period of care receives
points based on each of the responses associated with the functional
OASIS items which are then converted into a table of points
corresponding to increased resource use (see Table 28). The sum of all
of these points results in a functional score which is used to group
home health periods into a functional level with similar resource use.
We are finalizing three functional levels of low impairment, medium
impairment, and high impairment with approximately one third of home
health periods from each of the clinical groups within each functional
impairment level (see Table 29). For the implementation of the PDGM in
CY 2020, we will update the functional points and functional thresholds
as previously described based on analysis of CY 2018 home health
claims, and using the most current version of the OASIS data set, to
reflect any changes in resource use associated with these variables.
Likewise, as articulated in the proposed rule and throughout this final
rule with comment period, once the PDGM is implemented in CY 2020, we
will continue to analyze the impact of all of the PDGM case mix
variables to determine if any additional refinements need to made to
ensure that all variables used as part of the overall case-mix
adjustment appropriately align home health payment with the actual cost
of providing home health care services.
8. Comorbidity Adjustment
The proposed PDGM groups home health periods based on the primary
reason for home health care (principal diagnosis), functional level,
admission source, and timing. To further account for differences in
resource use based on patient characteristics, we proposed to use the
presence of home health specific comorbidities as part of the overall
case-mix adjustment under the PDGM. 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. These
broad, body system-based categories we proposed to use to group
comorbidities within the PDGM included the following:
Heart Disease.
Respiratory Disease.
Circulatory Disease and Blood Disorders.
Cerebral Vascular Disease.
Gastrointestinal Disease.
Neurological Disease and Associated Conditions.
Endocrine Disease.
Neoplasms.
Genitourinary and Renal Disease.
Skin Disease.
Musculoskeletal Disease or Injury.
Behavioral Health (including Substance Use Disorders).
Infectious Disease.
These broader categories were further refined into comorbidity
subcategories to more accurately capture differences in resource use.
All of the comorbidity diagnoses grouped into these comorbidity
categories and subcategories are posted on the Home Health Agency web
page and listed in the HHGM technical report, ``Medicare Home Health
Prospective Payment System: Case-Mix Methodology Refinements Overview
of the Home Health Groupings Model'', at the following link: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.html.
We originally proposed in the CY 2018 HH PPS proposed rule that if
a period had at least one secondary diagnosis reported on the home
health claim that fell into one of the proposed body-system based
subcategories listed in that rule, the period would receive a
comorbidity adjustment to account for higher costs associated with the
comorbidity (82 FR 35309). A period would receive only one comorbidity
adjustment regardless of the number of secondary diagnoses reported on
the home health claim that fell into one of the subcategories. We
received comments supporting the inclusion of a comorbidity adjustment,
but the
[[Page 56487]]
majority of commenters also stated that the presence of multiple
comorbidities has more of an effect on home health resource use than a
single comorbidity. We agreed with commenters that the relationship
between comorbidities and resource use can be complex and that a single
adjustment, regardless of type or number of comorbidities, may be
insufficient to fully capture the resource use of a varied population
of home health beneficiaries. A TEP was convened and we conducted
additional analyses on methodologies for incorporating multiple
comorbidity adjustments into the PDGM. There was general agreement that
most home health patients have multiple conditions which increase the
complexity of their care and affects the ability to care for one's self
at home (83 FR 32375).
Taking these comments into consideration, CMS conducted additional
analysis on the effect of comorbidities on resource utilization during
a home health period of care. The goal of our analyses was to identify
those clinically and statistically significant comorbidities and
interactions that could be used to further case-mix adjust a 30-day
home health period of care. In the CY 2019 HH PPS proposed rule, we
described the methodology used to identify, group, and appropriately
weight comorbidity subgroups and interactions between subgroups (83 FR
32375). As a result of these analyses, we identified that there were
certain individual comorbidity subgroups and interactions of the
comorbidity subgroups (for example, having diagnoses associated with
two of the comorbidity subgroups) which could be used as part of the
comorbidity case-mix adjustment in the PDGM. This meant that patients
with certain comorbidities and interactions of certain comorbid
conditions have home health periods of care with higher resource use
than home health periods of care without those comorbidities or
interactions. Specifically, we identified individual comorbidity
subgroups that were statistically and clinically significant for case-
mix adjustment and these are identified in Table 30. From the
individual comorbidity subgroups, we then identified a subset of
statistically and clinically significant comorbidity interactions for
case-mix adjustment and these are identified in Table 31.
In the CY 2019 HH PPS proposed rule, we proposed three mutually
exclusive levels of comorbidity case-mix adjustment that depend on the
presence of certain secondary diagnoses codes: No Comorbidity
Adjustment, Low Comorbidity Adjustment, and High Comorbidity
adjustment. We proposed that home health 30-day periods of care can
receive a comorbidity payment adjustment under the following
circumstances:
Low comorbidity adjustment: A 30-day period of care would
receive a low comorbidity adjustment if there is a reported secondary
diagnosis that falls within one of the home-health specific individual
comorbidity subgroups, as listed in Table 30, for example, Heart 11,
Cerebral 4, etc., associated with higher resource use, or;
High comorbidity adjustment: A 30-day period of care would
receive a high comorbidity adjustment if a 30-day period has two or
more secondary diagnoses reported that fall within one or more of the
comorbidity subgroup interactions, as listed in Table 31, for example,
Heart 11 plus Neuro 5, that are associated with higher resource use.
A 30-day period would receive no comorbidity adjustment if no
secondary diagnoses exist or none meet the criteria. A 30-day period of
care can receive only one comorbidity adjustment--low or high--
regardless of the number of subgroups or subgroup interactions. We
proposed that the low comorbidity adjustment amount would be the same
across the individual subgroups and the high comorbidity adjustment
would be the same across the subgroup interactions. Table 46 in the CY
2019 HH PPS proposed rule showed the average resource use by
comorbidity adjustment (83 FR 32411).
With dividing the MMTA clinical group into subgroups as finalized
in section III.E.6 of this final rule with comment period, we note that
the number of comorbidity subgroups in both the low and high
comorbidity adjustment is higher than as described in the CY 2019 HH
PPS proposed rule. This more recent analysis of CY 2017 home health
claims results in 13 comorbidity subgroups which would receive the low
comorbidity adjustment and 34 comorbidity subgroup interactions which
would receive the high comorbidity adjustment (see Tables 30 and 31).
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We solicited comments on the comorbidity case-mix adjustment in the
PDGM, which includes three comorbidity levels: No Comorbidity, Low
Comorbidity, and High Comorbidity Adjustment. We also invited comment
on the payments associated with the Low and High Comorbidity Adjustment
to account for increased resource utilization resulting from the
presence of certain comorbidities and comorbidity interactions. These
comments are summarized in this section along with our responses.
Comment: The majority of commenters were generally supportive of
the change in the comorbidity adjustment in the PDGM to include both a
low and high comorbidity adjustment and believe that adding the Low and
High Comorbidity adjustment will yield a more accurate and robust
payment that accounts for the additional resource intensity needed to
care for patients with multiple comorbidities. Commenters stated that
it is appropriate to examine the relationship of reported comorbidities
on resource utilization to ensure that payment is in alignment with the
actual costs of providing care. Several commenters encourage ongoing
monitoring to ensure that subcategories of diagnoses and associated
comorbidity payment adjustments remain appropriate and adequate.
Several commenters believe the comorbidity adjustment should be
expanded since as proposed it would only apply to only a small
proportion of patients compared to the number of home health patients
with multiple chronic conditions. This would result in providers facing
financial difficulty in caring for medically complex patients. A
commenter urged us to expand the Low Comorbidity Adjustment criteria.
Another commenter believe the comorbidity adjustment was overly
simplistic and that it should incorporate social determinants of
health. The commenter also suggested inclusion additional comorbidity
adjustments levels, including moderate and very high.
Response: We thank the commenters for their support regarding a
comorbidity case-mix adjustment that accounts for the interaction
between multiple comorbid conditions. We believe that this change for
the PDGM (compared to the comorbidity adjustment proposed under the
HHGM) addresses stakeholder comments regarding the impact of the
presence of multiple comorbidities and their interactions on resource
utilization. This change also helps to ensure that payment is more in
alignment with the actual costs of providing care.
We agree that continued monitoring is needed to understand how the
PDGM, including the comorbidity adjustment, affects home health
patients and providers and inform future refinements. While we are
aware of the prevalence of comorbidities 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. For example, if the Medicare home health patient population
has an average of three comorbidities then this is already factored
into the base rate given that this rate represents the average home
health payment for the average patient. The case-mix adjustment process
recognizes increased resource use beyond the average. If the
``average'' patient under home health is multi-morbid, then additional
resource use is not evident as the data reflects this average.
As noted in the CY 2019 HH PPS proposed rule, the comorbidity
subgroups were selected through a stepwise process that identified
clinically and statistically meaningful diagnosis-based comorbidity
groups that were associated with higher resource use than the average
or that would be indicated by examining clinical and functional groups,
admission source, and timing characteristics. As such, the comorbidity
subgroups were meant to identify only those cases when resource use was
higher than the median when accounting for other attributions of the
patient. A similar process was used to identify the comorbidity
subgroup interactions that would result in a high comorbidity
adjustment. We agree that social determinants of health is an important
consideration in providing effective patient-centered health care, and
we thank the commenter for raising this point. However, the comorbidity
adjustment in the PDGM is meant to capture clinical conditions that are
present that affect resource utilization under a home health plan of
care.
We anticipate that we would annually recalibrate the PDGM case-mix
weights, which would include the comorbidity adjustment. This would be
similar to the annual recalibration of case mix weights under the
current HH PPS. Therefore, this could mean additions or subtractions of
comorbidity subgroups and/or comorbidity subgroup interactions in the
low and/or high comorbidity adjustment groups in the future. We will
continue to analyze and monitor reported secondary diagnoses to inform
the need for any future refinements to the comorbidity adjustment under
the PDGM.
Comment: Some commenters remarked that the comorbidity adjustment
would provide insufficient payment for providers and that not enough
periods of care would receive a comorbidity adjustment even though the
treatment of home health patients with comorbidities is commonplace.
Another commenter stated that the average amount of $35 for low
comorbidity adjustment and $350 for high comorbidity adjustment is out
of sync
[[Page 56490]]
with the costs of serving these complex beneficiaries. Another
commenter stated that the comorbidity adjustment is not adequate to
cover ancillary services. These same commenters wrote that this would
expose a high proportion of HHAs to additional risk and recommended
that CMS return to its' comorbidity payment adjustment as proposed
under the HHGM in the CY 2018 HH PPS proposed rule or to expand both
the application and the value of the PDGM's low comorbidity adjustment
so that it would more fully cover the frequent instances in which more
complex care is provided to those beneficiaries with comorbid
conditions.
Response: The payments associated with the low and high comorbidity
adjustment are the result of actual resource utilization as reported on
home health claims. As detailed in both the CY 2018 HH PPS proposed
rule (82 FR 35322) and the CY 2019 HH PPS proposed rule (83 FR 32407),
we analyzed home health claims to determine the actual resource
utilization associated with the presence of certain comorbid
conditions. We remind commenters that the additional diagnoses used for
analysis are reported by the HHAs themselves and therefore we could
only analyze those comorbidities reported, whether or not beneficiaries
receiving home health care had other, unreported conditions that
potentially could have affected resource utilization. Regardless, the
payment amount proposed for the low and high comorbidity adjustment is
driven by the actual resource utilization as identified on home health
claims and therefore we believe to be sufficient to align the
comorbidity adjustment to the costs of providing care. Likewise, the
difference in payment between the low and the high comorbidity
adjustment is reflective of the resource use between those patients
with individual comorbid conditions and those with multiple comorbid
conditions. This is also in alignment with what commenters and the TEP
that was convened in February 2018 stated in regards to the more
complex needs of patients who have multiple comorbidities.
We disagree with commenters who stated that not enough periods of
care would receive the comorbidity adjustment. To better ensure that
reported conditions represented an actual impact on resource use, the
proposed comorbidities include those conditions that represent more
than 0.1 percent of periods and have at least as high as the median
resource use as they indicate a direct relationship between the
comorbidity and resource utilization. Under the PDGM, this approach
increases the 30-day periods of care that would receive a comorbidity
adjustment compared to the approach proposed in the CY 2018 HH PPS
proposed rule. Under the proposed PDGM, almost 40 percent of home
health periods of care would receive a low or high comorbidity
adjustment compared to approximately 15 percent of home health periods
under the HHGM. We believe a more granular approach to the comorbidity
adjustment more accurately represents patient characteristics and more
accurately aligns payments with the cost of providing care. Again, we
remind commenters that the comorbidity adjustment is just one of the
case-mix variables in the PDGM made in addition to the base payment and
adjustments made for clinical and functional status, admission source,
and timing. These variables work in tandem to account for the
complexity of patient care needs and to make payment for home health
services accordingly. Similarly, the HH PPS is a bundled payment to
cover all home health services, including ancillary services such as
home health aides. HHAs are expected to provide the services, including
the disciplines responsible for providing those services, in accordance
with the home health plan of care.
We disagree that this approach to a comorbidity adjustment exposes
HHAs to additional risk. In the CY 2001 HH PPS final rule, commenters
stated that patients with multiple diagnoses should be credited with
additional points in their clinical dimension measurement given the
impact of comorbidities on resource use (65 FR 41153). We stated that
time constraints and the data available during the development of the
HH PPS was not robust enough for the inclusion of a comorbidity
variable as part of the HH PPS case-mix adjustment (65 FR 41153). We
also reiterated that we would consider comorbidities for future case-
mix analyses and that such an effort would be significantly aided by
complete four-digit and 5-digit diagnosis coding on the OASIS record.
In the CY 2008 HH PPS final rule (72 FR 49772), we added secondary
diagnoses and their interactions with the principal diagnosis as part
of the clinical dimension in the overall case-mix adjustment. However,
analysis since that time has shown that nominal case-mix growth became
an ongoing issue resulting from the incentive in the current HH PPS to
code only those conditions associated with clinical points even though
the data did not show an associated increase in resource utilization.
For CY 2018, there was a 0.97 percent reduction to the national,
standardized 60-day payment rate to account for nominal case-mix growth
between CY 2012 and CY 2014. Therefore, during the development of the
PDGM, we sought to mitigate nominal case-mix growth and looked at
different ways to account for comorbidities in the overall case-mix
adjustment. The description of the initial comorbidity analysis for an
alternate case-mix methodology is included in the technical report,
``Overview of the Home Health Groupings Model'' found on the HHA Center
web page.\30\
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\30\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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Comment: A commenter expressed concern that underlying mood
disorders, cognitive impairments and other behavioral issues may be
underreported and therefore not prevalent enough to be represented in a
comorbidity subgroup. The commenter further noted that current
guidelines state that clinicians should list diagnoses that support the
disciplines and services provided, which appears contrary to current
guidance to report any and all diagnoses the patient has whether or not
they are related to treatment indicated in the plan of care.
Response: Behavioral Health Care is one of the PDGM clinical
groupings, and as such, principal diagnoses related to these conditions
are already incorporated into the case-mix weight. HHAs already should
be reporting any and all secondary diagnoses on the plan of care that
affect resource use, including diagnoses related to cognitive and
behavioral issues. We agree that coding guidelines are clear that
additional (secondary) diagnoses are only to be reported if they are
conditions that affect patient care in terms of requiring clinical
evaluation; or therapeutic treatment; or diagnostic procedures; or
extended length of hospital stay; or increased nursing care and/or
monitoring. We do not expect that HHAs would report comorbid conditions
that are not being addressed in the individualized plan of care. The
home health CoPs at Sec. 484.60 state that the plan of care must
specify the care and services necessary to meet the patient-specific
needs as identified in the comprehensive assessment, which would
include all pertinent diagnoses.
Comment: A commenter stated patients with comorbidities frequently
require multiple episodes of home health care and instead of the
comorbidity adjustment, the PDGM should have more payment groups to
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more accurately predict resource use among patients.
Response: We remind commenters that the subdivision of the MMTA
clinical group into subgroups, as finalized in section III.F.6 of this
final rule with comment period, results in 432 payment groups in the
PDGM. Therefore, we believe that the presence of more clinical groups
better describes patient characteristics and care needs which will
translate to more accurate payment. Likewise, adjusting a home health
period of care payment to account for the presence of comorbidities
will help to more accurately pay for those patients with chronic,
comorbid conditions who require multiple periods of home health care.
Comment: We received a specific comment on the comorbidity
subgroups where a commenter recommended that instead of having Skin 3
and Skin 4 should be in their own separate clinical group instead of
including them as part of the comorbidity adjustment.
Response: The diagnoses that are in the Skin 3 and Skin 4
comorbidity subgroups are already included in the Wounds clinical group
and therefore are already accounted for in a separate clinical group.
We believe it is important, clinically, to retain these two subgroups
in the comorbidity adjustment as these can be conditions found in
patients who are primarily receiving home health services for other
reasons. For example, a patient who has recently suffered from a stroke
with significant functional deficits and developed a pressure ulcer
would likely be appropriately grouped into the Neuro Rehab group.
Having these comorbidity subgroups which represent the presence of
chronic wounds and/or pressure ulcers would provide additional payment
to account for the complex care needs of a patient receiving Neuro
Rehab services and who also has a wound. However, we will continue to
reexamine reported secondary diagnoses upon implementation of the PDGM
to see which conditions are associated with increased resource use and
will make any refinements, as necessary, to more accurately align
payment with patient characteristics and costs.
Comment: Another commenter stated that with the adoption of ICD 10-
CM, HHAs have been instructed through coding guidance to code all
diagnoses that impact the patient's care and that it is not uncommon to
fill all 25 code fields on the claim. This commenter remarked that
Direct Data Entry (DDE) only considers the first 9 codes on the
patient's claim and therefore would limit payment for those periods of
care if there are any comorbidities listed beyond the first 9 diagnosis
fields on the claim.
Response: We remind commenters that the DDE supports 25 diagnoses
just like the electronic 837I claim format. The difference between the
DDE and the electronic formats is that for the DDE format, the
reporting of diagnosis codes is split between two screens, meaning the
first 9 diagnosis codes are entered on the first screen, and diagnosis
codes 10-25 are entered on the second screen. To reach the second
screen to enter these codes, the person entering the claim information
would hit the F6 key to move from the first screen to the second
screen.
Final Decision: After considering the public comments, we are
finalizing the comorbidity adjustment as part of the overall case mix
in the PDGM. To summarize, this includes the home health specific list
of comorbidity subgroups and comorbidity subgroup interactions. One of
the three mutually exclusive categories of comorbidity adjustment will
be applied to each period: No Comorbidity Adjustment, Low Comorbidity
Adjustment, and High Comorbidity Adjustment. A 30-day period of care
can receive payment for 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 would be the same
across the subgroups and the high comorbidity adjustment would be the
same across the subgroup interactions. Upon implementation of the PDGM
in CY 2020, we will analyze the most recently available claims to
update the comorbidity list to include those comorbid conditions and
interaction subgroups that represent more than 0.1 percent of periods
and have at least as high as the median resource use. Likewise, we will
continue to evaluate reported secondary diagnoses and interactions
between comorbidities to identify their impact on resource costs to
determine if any additional refinements to this case-mix adjustment
variable are warranted.
9. Change in the Low-Utilization Payment Adjustment (LUPA) Threshold
Currently, 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). While the proposed
PDGM system in the CY 2019 HH PPS proposed rule would still include
LUPA payments, the approach to calculating the LUPA thresholds needed
to change due to the proposed change in the unit of payment to 30-day
periods of care from 60-day episodes. We note that in the current
payment system, approximately 8 percent of episodes are LUPAs. Under
the PDGM, the 30-day periods of care have substantially more periods
with four or fewer visits than 60-day episodes. Therefore, to create
LUPA thresholds under the PDGM, in the CY 2019 proposed rule (82 FR
32411), we proposed to set the LUPA threshold at the 10th percentile
value of visits or 2 visits, whichever is higher, for each payment
group in order to target approximately the same percentage of LUPAs.
This resulted in approximately 7.1 percent of 30-day periods that would
be LUPAs (assuming no behavior change) under the PDGM. We also proposed
that the LUPA thresholds for each PDGM payment group would be re-
evaluated every year based on the most current utilization data
available.
We received several comments on the LUPA threshold methodology
proposed for the PDGM and these are summarized in this section with our
responses:
Comment: Several commenters agreed in concept with the proposed
changes to the LUPA threshold, but stated that additional time is
necessary to fully evaluate the model's impact, especially in
conjunction with the transition from a 60-day to a 30-day payment
period. Several commenters requested a more cautious approach of
delayed implementation, to allow providers and software vendors an
opportunity to prepare for implementation of the new thresholds.
Response: We appreciate commenters agreeing that LUPA thresholds
should vary by clinical group. LUPA thresholds that vary by case-mix
group level take into account different resource use patterns based on
clinical characteristics and is a more patient-driven approach. We note
that we will implement the PDGM for home health periods of care
starting on or after January 1, 2020, giving HHAs and vendors
sufficient time to evaluate the impact of the PDGM and make necessary
changes to their software systems to accommodate a 30-day unit of
payment and the varying LUPA threshold approach.
Comment: Many commenters expressed concern that creating
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different LUPA thresholds, in which the thresholds vary from 2-6
minimum visits, depending on the home health grouping, will greatly
increase the complexity of the payment system, administrative burden,
and costs to agencies. Several commenters suggested maintaining the use
of a single LUPA threshold. Other commenters suggested a system of
varying LUPA thresholds (that is, more than one), but more simplified
to include a narrower range of thresholds than the proposed 2-6
thresholds. Commenters recommended that any LUPA threshold options
should be fully evaluated for potential impacts, including behavioral
changes that could affect patient access to care.
Response: The concept of case-mix adjusted LUPA thresholds is not
new. In the FY 2001 HH PPS final rule (42 FR 41143), when the LUPA
threshold of four or fewer visits was introduced, commenters suggested
that CMS instead use specific LUPA thresholds for each HHRG. We are
unsure why case-mix-specific LUPA thresholds would result in additional
administrative burden and costs. 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. We are unsure why case-mix
group specific LUPA thresholds would impact patient access and
commenters did not provide any additional information to inform such
assertions. While some commenters suggested a system of varying LUPA
thresholds (that is, more than one), but more simplified to include a
narrower range of thresholds than the proposed 2-6 thresholds, they did
not provide specifics on their recommendation nor any rationale for
this suggestion. However, we remind commenters that we set the LUPA
threshold at the 10th percentile value of visits or 2 visits, whichever
is higher, for each payment group in order to target approximately the
same percentage of LUPAs as under the current system. Therefore, we
believe this approach to be the most reasonable. However, we will
analyze this methodology once the PDGM is implemented in CY 2020 to
determine whether any changes to the LUPA thresholds are warranted.
Comment: Several commenters expressed concern that this policy
change could increase the number of LUPAs, which present a financial
loss for agencies. A commenter remarked that a 60-day episode under the
current system with 14 visits would potentially become two 30-day LUPAs
under the proposed PDGM.
Response: As explained in the CY 2019 HH PPS proposed rule (83 FR
32412), our methodology for determining LUPA assignment was calibrated
to target approximately the same rate of LUPA occurrences as under the
current HH PPS case-mix system. Based on our analysis of CY 2017 home
health utilization data, under the PDGM, a slightly lower rate of 30-
periods would be assigned as LUPAs (approximately 7%) than 60-day
episodes under the current payment system (approximately 8%). We
believe that targeting approximately the same percentage of LUPA
periods under the PDGM as the current HH PPS should mitigate HHA
concerns of an increased number of LUPA periods of care and we do not
believe this approach would create a financial hardship for HHAs.
Comment: A commenter questioned the methodology of the LUPA
threshold calculation. They suggested that low counts of visits due to
the patient's death or transfer to another agency are not comparable
with counts of low visits due to patient needs and thereby these two
situations at least should be excluded when determining the thresholds.
Response: While we appreciate the commenter's suggestion, when we
examined the data, we found the combined occurrences of patient deaths
or transfers to another agency did not impact the threshold numbers.
Comment: Another commenter expressed concern about how the change
to the LUPA thresholds under the PDGM would affect the provision and
payment of Non-Routine Supplies (NRS). The commenter cited an example
of periods of care classified under the Wound clinical group for which
the commenter noted use disproportionately greater amounts of NRS, and
questioned whether the per-visit rates alone would be sufficient to
recoup costs. Another commenter noticed that, with some groupings and
all else equal, the threshold amounts can be seen to rise and then fall
with functional level and thereby the thresholds were not consistent
with patient needs.
Response: We remind commenters that payment for NRS has been
included in the per-visit LUPA rates since the implementation of the HH
PPS (65 FR 41128). At that time, commenters expressed concern that the
per-visit LUPA rates would not adequately compensate for NRS and the
per visit payment rates were updated to reflect those concerns (65 FR
41138). In the CY 2014 HH PPS final rule (72 FR 72280), we rebased the
national, per-visit payment amounts the highest amounts allowed by law.
Under the PDGM, the LUPA thresholds are data-driven and determined
based on the visit patterns reflected in each of the case-mix groups.
Any noted patterns of LUPA thresholds varying with functional level is
the result of provider reported information on the OASIS. Accurate
reporting on the OASIS is imperative to fully account for the level of
impairment at the time of the assessment and to be reflective of the
services provided. We reiterate, that in order to maintain
approximately the same proportion of LUPA periods under the PDGM with a
30-day unit of payment compared to the current HH PPS with a 60-day
episode of payment, the LUPA thresholds were set at the 10th percentile
of visits or 2 visits, whichever is higher.
Final Decision: We are finalizing our proposal to vary the LUPA
threshold for each 30-day period of care depending on the PDGM payment
group to which it is assigned. Likewise, we are finalizing that the
LUPA thresholds for each PDGM payment group will be re-evaluated every
year based on the most current utilization data available. The LUPA
thresholds for the PDGM payment groups with the corresponding HIPPS
codes based on CY 2017 home health data are listed in Table 32. Since
we propose to implement the PDGM on January 1, 2020, LUPA thresholds
for the PDGM payment groups with the corresponding HIPPS codes for CY
2020 will be updated in the CY 2020 HH PPS proposed rule using CY 2018
home health data.
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10. HH PPS Case-Mix Weights Under the PDGM
Section 1895(b)(4)(B) 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. In the CY 2019 HH PPS proposed rule
(83 FR 32415), we proposed an alternative case-mix adjustment
methodology to better align payment with patient care needs. The
proposed alternative case-mix adjustment methodology places patients
into meaningful payment categories based on patient characteristics
(principal diagnosis, functional level, comorbid conditions, referral
source and timing). As outlined in previous sections of this final rule
with comment period, we are finalizing this alternative case-mix
adjustment methodology, called the PDGM. This new methodology results
in 432 unique case-mix groups. These 432 unique case-mix payment groups
are called Home Health Resource Groups (HHRGs).
To generate PDGM case-mix weights, we utilized a data file based on
home health 30-day periods of care, as reported in Medicare home health
claims linked to OASIS assessment data to obtain patient
characteristics. The claims data provides visit-level data and data on
whether non-routine supplies (NRS) was provided during the period and
the total charges for NRS. We determined the case-mix weight for each
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of the different PDGM payment groups by regressing resource use on a
series of indicator variables for each of the categories using a fixed
effects model. The regression measures resource use with the Cost per
Minute (CPM) + NRS approach outlined in section III.F.2 of this final
rule with comment period. The model used in the PDGM payment regression
generates outcomes that are statistically significant.
After best fitting the model on CY 2017 home health data, we used
the estimated coefficients of the model to predict the expected average
resource use of each 30-day period based on the five PDGM categories.
In order to normalize the results, we divided the regression predicted
resource use of each 30-day period by the overall average resource use
used to estimate the model in order to calculate the case mix weight of
all periods within a particular payment group, where each payment group
is defined as the unique combination of the subgroups within the five
PDGM categories (admission source, timing of the 30-day period,
clinical grouping, functional impairment level, and comorbidity
adjustment). The case-mix weight is then used to adjust the base
payment rate to determine each period's payment. Table 48 shows the
coefficients of the payment regression used to generate the weights,
and the coefficients divided by average resource use. Information can
be found in section III.F.6 of this rule for the clinical groups,
section III.F.7 of this rule for the functional impairment levels,
section III.F.5 for admission source, section III.F.4 for timing, and
section III.F.8 for the comorbidity adjustment.
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Table 34 presents the case-mix weight for each Home Health Resource
Group (HHRG) in the regression model. LUPA episodes, outlier episodes,
and episodes with PEP adjustments were excluded. Weights are determined
by first calculating the predicted resource use for episodes with a
particular combination of admission source, episode timing, clinical
grouping, functional impairment level, and comorbidity adjustment. This
[[Page 56505]]
combination specific calculation is then divided by the average
resource use of all the episodes that were used to estimate the
standard 30-day payment rate. The resulting ratio represents the case-
mix weight for that particular combination of a HHRG payment group. The
adjusted R-squared value provides a measure of how well observed
outcomes are replicated by the model, based on the proportion of total
variation of outcomes explained by the model.
Similar to the annual recalibration of the case-mix weights under
the current HH PPS, we proposed to annually recalibrate the PDGM case-
mix weights. We note that this includes a re-calculation of the
proposed PDGM case-mix weights for CY 2020 in the CY 2020 HH PPS
proposed rule using CY 2018 home health claims data linked with OASIS
assessment data since we will implement the PDGM for 30-day periods of
care beginning on or after January 1, 2020.
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In conjunction with the implementation of the PDGM, in the CY 2019
HH PPS proposed rule (83 FR 32420) we proposed to revise the frequency
with which we update the HH PPS Grouper software used to assign the
appropriate HIPPS code used for case-mix adjustment onto the claim.
Since CY 2004 when the HH PPS moved from a fiscal year to a calendar
year basis, we have updated the Grouper software twice a year. We
provide an
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updated version of the Grouper software effective every October 1 in
order to address ICD coding revisions, which are effective on October
1. We also provide an updated version of the HH PPS Grouper software
effective on January 1 in order to capture the new or revised HH PPS
policies that become effective on January 1. In an effort to reduce
provider burden associated with testing and installing two software
releases, we proposed to discontinue the October release of the HH PPS
Grouper software and provide a single HH PPS Grouper software release
effective January 1 of each calendar year. We proposed that the January
release of the HH PPS Grouper software would include the most recent
revisions to the ICD coding system as well as the payment policy
updates contained in the HH PPS final rule.
We solicited public comments on the proposed PDGM case-mix weights,
case-mix weight methodology and proposed annual recalibration of the
case-mix weights, updates to the HH PPS Grouper software, and the
associated regulations text changes in section III.F.13 of this
proposed rule. The following is a summary of the public comments on the
case mix weight methodology under PDGM and the updates to the HH PPS
Grouper Software and our responses:
Comment: A few commenters urged CMS to formalize a transparent
process and timeline to refine the case-mix weights soon after
implementation of the PDGM, to assess whether various factors will
influence the ability of the model to better predict resource use, such
as additional secondary diagnoses or interactions between such
diagnoses. The commenters noted that it is imperative that the case-mix
weights reflect current care protocols and resource needs. A few
commenters suggested that CMS provide further explanation of how the
new model addresses the concerns for those patients with complex,
chronic care needs (for example, an ALS patient is referenced). Another
commenter questioned how the PDGM could address issues of access, since
beneficiaries without access to home health are by definition not
included in the analysis (which was done based on prior utilization
records).
Response: As noted in the CY 2019 HH PPS proposed rule (83 FR
32416), we proposed to annually recalibrate the PDGM case-mix weights
to reflect the most recent utilization data available at the time of
rulemaking. Once the PDGM is finalized, we will also continue to
analyze all of the components of the case-mix adjustment, and make
refinements as necessary to ensure that payment for home health periods
are in alignment with costs. We note that we provide a clinical example
in section III.F.12 of this final rule with comment period,
specifically relating to ALS, that shows how high cost periods of care
could receive outlier payments under the PDGM.
Comment: Numerous commenters agreed that the October release of the
Grouper should be discontinued (and only the January release be
retained) as long as HHAs would not be at risk for violating HIPAA
rules, if the agency were to potentially use an incorrect diagnosis
code in the last quarter of the year (incorrect in the sense that the
coding was made obsolete by ICD-10 refinements that were not reflected
in the Grouper until the following January). A commenter expressed
approval at this effort to reduce burdens on HHAs (although also
expressed concern over the issue with HIPAA rules). Another commenter
questioned how this would impact other Medicare claims and coding,
noting that many agencies also operate hospice businesses, and the
situation can be confusing if hospice still operates under the Fiscal
Year guidance whereas Home Health operates under the Calendar Year
guidance.
Response: We thank commenters for their support in findings ways to
reduce regulatory burden and potentially streamlining the HH PPS
Grouper into one annual release. However, upon further examination of
this proposal, we recognize that this could lead to potential Health
Insurance Portability and Accountability Act (HIPAA) violations for
HHAs. HIPAA requires that covered entities use the current adopted code
set (45 CFR 162.1000). If the ICD-10-CM code set is implemented in
October then that would be the current code set and using outdated
codes from October through the following January would be non-compliant
with HIPAA requirements. However, in an effort to reduce provider
burden associated with the release of two Groupers, we will continue to
examine ways to minimize this burden. For example, if we do not update
the functional impairment level points and thresholds on an annual
basis, we could eliminate the need for a second Grouper release in
January and instead update the Grouper for October 1 when ICD-10-CM
code changes become effective. While we would continue to annually
recalibrate the PDGM case-mix weights, we may not need to update the
points and thresholds annually. Any changes to the Grouper releases or
the updates to the functional points and thresholds would be proposed
in future rulemaking.
Final Decision: We are finalizing the PDGM, with the modifications
previously discussed, effective for 30-day periods of care that start
on or after January 1, 2020. Additionally, we are finalizing our
proposal to generate PDGM case-mix weights for each of the different
PDGM payment groups by regressing resource use on a series of indicator
variables for each of the five categories previously listed (timing,
admission source, clinical grouping, functional level, and comorbidity)
using a fixed effects model and annually recalibrating the PDGM case-
mix weights to ensure that the case-mix weights reflect the most recent
utilization data available at the time of annual rulemaking. We are not
finalizing the discontinuation of the October release of the HH PPS
Grouper software update given the potential for HIPAA violations.
Therefore, we will continue to release Grouper software in both October
and January of each year. Any proposals to discontinue any one of the
Grouper software releases would be included in future rulemaking for
public comment.
11. Low-Utilization Payment Adjustment (LUPA) Add-On Payments and
Partial Payment Adjustments Under PDGM
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. Under the PDGM, we proposed that
the LUPA add-on factors will remain the same as the current payment
system, described in the CY 2019 HH PPS proposed rule (83 FR 32372). We
proposed to multiply the per-visit payment amount for the first SN, PT,
or SLP visit in LUPA 30-day periods that occur as the only 30-day
period or an initial 30-day period in a sequence of adjacent periods of
care by the appropriate factor (1.8451 for SN, 1.6700 for PT, and
1.6266 for SLP) to
[[Page 56516]]
determine the LUPA add-on payment amount.
The current partial episode payment (PEP) adjustment is a
proportion of the episode payment and is based on the span of days
including the start-of-care date (the date of the first billable
service) through and including the last billable service date under the
original plan of care before an intervening event in a home health
beneficiary's care defined as:
A beneficiary elected transfer, or
A 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.
For 30-day periods of care, we proposed that the process for
partial payment adjustments would remain the same as the existing
policies pertaining to partial episode payments. When a new 30-day
period begins due to the intervening event of a beneficiary elected
transfer or there was a discharge and return to home health during the
30-day period, we proposed that the original 30-day period would 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 would 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 30. The
proportion would then be multiplied by the original case-mix and wage
index to produce the 30-day payment.
We solicited public comments on the LUPA add-on payments and
partial payment adjustments proposed for the PDGM and the associated
changes in the regulations text. The following is a summary of the
public comments and our responses:
Comment: Another commenter requested clarification on the use of
the word ``episode' in the CY 2019 HH PPS proposed rule (83 FR 32421)
and whether the first two 30-day periods (the former 60-day episode
timeframe) would both receive the LUPA add-on payment or only the
initial 30-day period. The commenter's expectation was that the add-on
payment would only be paid to the initial 30-day period.
Response: The commenter's assumption was correct; the LUPA add-on
payment amount under the PDGM will only be paid to LUPA periods that
occur as the only period of care or the initial 30-day period of care
in a sequence of additional periods of care by the appropriate add-on
factor.
Final Decision: We are finalizing our proposal to 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 are also finalizing our proposal to retain the
current PEP policy and apply such policy to 30-day periods of care
under the PDGM.
12. Payments for High-Cost Outliers Under the PGDM
As described in section III.E. of the CY 2019 HH PPS proposed rule
(83 FR 32375), section 1895(b)(5) of the Act allows for the provision
of an addition or adjustment to the home health payment amount in the
case of outliers because of unusual variations in the type or amount of
medically necessary care. The history of and current methodology for
payment of high-cost outliers under the HH PPS is described in detail
in section III.E. of the CY 2019 HH PPS proposed rule (83 FR 32375). We
proposed that we would maintain the current methodology for payment of
high-cost outliers upon implementation of the PGDM and that we would
calculate payment for high-cost outliers based upon 30-day periods of
care.
As discussed in the CY 2019 HH PPS proposed rule (83 FR 32421), we
updated our outlier estimates for this final rule with comment period.
Simulating payments using preliminary CY 2017 claims data and the CY
2019 payment rates, we estimated that outlier payments under the PGDM
with 30-day periods of care would comprise approximately 4.77 percent
of total HH PPS payments in CY 2019. Given the statutory requirement
that estimated total outlier payments do not exceed the 2.5 percent of
total payments (as required by section 1895(b)(5)(A) of the Act), we
estimated that the FDL ratio under the PGDM would need to change to
0.71 to maintain compliance with statute. However, given the
implementation of the PGDM for 30-day periods of care beginning on or
after January 1, 2020, we will update our estimate of outlier payments
as a percent of total HH PPS payments using the most current and
complete utilization data available at the time of CY 2020 rate setting
and would propose a change in the FDL ratio for CY 2020, if needed.
We solicited public comments on maintaining the current outlier
payment methodology for the PGDM and the associated changes in the
regulations text. The following is a summary of the public comments and
our responses:
Comment: Several commenters indicated their support for the
proposal to continue outlier payments under the PDGM.
Response: We thank the commenters for the support of this continued
payment policy.
Comment: Several commenters suggested that we develop an outlier
policy under the PGDM that is comparable to the existing system but
modified to reflect the change to the 30-day payment period and also
consider further refinement to ensure a smooth transition within the
framework of the PGDM. Another commenter expressed concern regarding
the potential for more providers to exceed the 10 percent outlier cap
under a 30-day period of care and also suggested modification to the 8-
hour cap on the amount of time per day that is permitted to be counted
toward the estimation of a period's costs for outlier calculation
purposes. A few commenters stated that they believed that the cap on
outlier payments would prevent necessary care and cause providers to
seek beneficiaries with profiles that could help maximize profits.
Response: We believe that our proposal to maintain the existing
outlier policy under the PGDM, except that outlier payments would be
determined on a 30-day basis to align with the 30-day unit of payment
under the PGDM, is comparable to the existing system and would ensure a
smooth transition within the framework on the PGDM. We plan to closely
evaluate and model projected outlier payments within the framework of
the PGDM and consider modifications to the outlier policy as
appropriate. We note that the maximum of 2.5 percent of outlier
payments to total payments and the 10 percent cap on outlier payments
at the home health agency level are statutory requirements, as
described in section 1895(b)(5) of the Act. Therefore, we do not have
the authority to adjust or eliminate the 10-percent cap or increase the
2.5 percent maximum amount.
Regarding the 8-hour limit on the amount of time per day counted
toward the estimation of a period's costs, as noted in the CY2017 HH
PPS final rule (81 FR 76729), where a patient is eligible for coverage
of home health services, Medicare statute limits the amount of part-
time or intermittent
[[Page 56517]]
home health aide services and skilled nursing services covered during a
home health episode. Section 1861(m)(7)(B) of the Act states that the
term ``part-time or intermittent services'' means skilled nursing and
home health aide services furnished any number of days per week as long
as they are furnished (combined) less than 8 hours each day and 28 or
fewer hours each week (or, subject to review on a case-by-case basis as
to the need for care, less than 8 hours each day and 35 or fewer hours
per week).'' Therefore, the daily and weekly cap on the amount of
skilled nursing and home health aide services combined is a limit
defined within the statute. As we further noted in the CY2018 HH PPS
final rule (81 FR 76729), because outlier payments are predominately
driven by the provision of skilled nursing services, the 8-hour daily
cap on services aligns with the statute, which requires that skilled
nursing and home health aide services be furnished less than 8 hours
each day. Therefore, we believe that maintaining the 8-hour per day cap
is appropriate under the new PGDM. However, we plan to monitor for any
unintended results of this policy as data become available.
Comment: Another commenter expressed concern regarding the change
to 30-day payment periods and its impact to the outlier payment policy.
The commenter believes that the 30-day periods and resultant adjustment
to the fixed dollar loss ratio would then make it harder for
beneficiaries to obtain outlier services.
Response: As described in detail in the CY 2019 HH PPS proposed
rule (83 FR 32340), 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 higher FDL ratio reduces the number of episodes 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. Alternatively, a lower FDL ratio means
that more episodes can qualify for outlier payments, but outlier
payments per episode must then be lower. As we evaluate the final
features of the PDGM for implementation in CY 2020, we will evaluate
and consider the potential for impacts of a modified FDL. While a
higher FDL value would potentially lessen the number of home health
periods that qualify for an outlier payment, those periods that did
qualify for an outlier payment could potentially receive a
proportionally higher outlier payment amount. Additionally, we note
that the 2.5 percent target of outlier payments to total payments and
the 10 percent cap on outlier payments at the home health agency level
are statutory requirements, as described in section 1895(b)(5) of the
Act. Moreover, the forthcoming change to the 30-day payment period is
also statutory in that it is required by the BBA of 2018. We plan to
closely evaluate and model projected outlier payments within the
framework of the PDGM and consider modifications to the outlier policy
as appropriate.
Comment: Several commenters suggested that eligibility for an
outlier payment be updated to include NRS costs incurred and not just
imputed costs of service visits. Commenters asserted that the outlier
policy under the PDGM may not adequately cover the costs of wound care
products necessary to achieve excellent patient outcomes and
recommended that we design a more specific model that accurately pays
for NRS separately and establish an outlier payment model for very
complex wound-care patients.
Response: 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, we will consider whether to add supply costs to the outlier
calculations and evaluate whether such a policy change is appropriate
for future rulemaking, potentially in conjunction with the
implementation of the PDGM for CY 2020.
Comments: Commenters requested that we develop clinical examples
illustrating how outliers would be paid under the proposed PDGM,
similar to the examples provided for an ALS patient under the current
payment system in the CY 2019 HH PPS proposed rule.
Response: In section III.D. of the CY 2019 HH PPS proposed rule (83
FR 32340), we described a clinical example of how care for a patient
with amyotrophic lateral sclerosis (ALS), could qualify for an
additional outlier payment, which would serve to offset unusually high
costs associated with providing home health to a patient with unusual
variations in the amount of medically necessary care. Using the same
clinical scenario, in this final rule with comment period we provide an
example of how the provision of services per the home health plan of
care could emerge for a beneficiary with ALS who qualifies for the
Medicare home health benefit for the first two 30-day periods of care
under the PDGM. We note that this example is provided for illustrative
purposes only and does not constitute a specific Medicare payment
scenario.
Example One: First 30-day Period under the PDGM:
An ALS beneficiary may be assessed by a physician in the community
and subsequently be deemed to require home health services for skilled
nursing, physical therapy, occupational therapy, and a home health
aide. The beneficiary could receive skilled nursing twice a week for 45
minutes to assess dyspnea when transferring to a bedside commode, stage
two pressure ulcer of the sacrum, and pain status. In addition, a home
health aide could provide services for three hours in the morning and
three hours on Monday, Wednesday and Friday and two and a half hours in
the morning and two and half hours in the afternoon on Tuesday and
Thursdays to assist with bathing, dressing and transferring. Physical
therapy services twice a week for 45 minutes could be provided for
adaptive transfer techniques, and occupational therapy services could
be supplied twice a week for 45 minutes for assessment and teaching of
assistive devices for activities of daily living to prevent or slow
deterioration of the beneficiary's condition. Because of the patient's
condition, the first 30-day period of care would be placed into the
community early, neuro rehabilitation, high functional impairment, and
low comorbidity group (1BC21). For the purposes of this example, we
assume that services are rendered per week for a total of 4 weeks per
30-day period of care.
BILLING CODE 4120-01-P
[[Page 56518]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.059
[[Page 56519]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.060
For the first 30-day period of this clinical scenario under the
PDGM, the preceding calculation illustrates how HHAs would be paid by
Medicare for providing care to patients with higher resource use in
their homes.
Example Two: Second 30-day Period under the PDGM:
For the second 30-day period under the PDGM, the ALS beneficiary
continues to require the home health services of skilled nursing,
physical therapy, occupational therapy and a nurse's aide. The
beneficiary continues to receive skilled nursing twice a week to assess
dyspnea when transferring to a bedside commode, stage two pressure
ulcer at the sacrum, and pain status. A home health aide could provide
services for three hours in the morning and three hours on Monday,
Wednesday, and Friday and two and a half hours in the morning and two
and half hours in the afternoon on Tuesday and Thursdays to assist with
bathing, dressing, and transferring. Physical therapy services twice a
week for 45 minutes could be provided for adaptive transfer techniques,
and occupational therapy services could be supplied twice a week for 45
minutes for assessment and teaching of assistive devices for activities
of daily living to prevent or slow deterioration of the beneficiary's
condition. Given the beneficiary's condition the second 30-day period
of care would fall into the community late, neuro rehabilitation, high
functional impairment, and low comorbidity group (3BC21).
[[Page 56520]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.061
[[Page 56521]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.062
BILLING CODE 4120-01-C
For the second 30-day period of this clinical scenario, the
previous calculation demonstrates how outlier payments could be made
for patients with chronic, complex conditions under the PDGM. We note
that this example is presented for illustrative purposes only, and is
not intended to suggest that all diagnoses of ALS should receive the
grouping assignment or number of periods described here. The CMS
Grouper would assign these groups based on information in the OASIS. In
general, we expect that outlier payments for unusually high cost
periods in PDGM will be comparable to those under the current system,
but there may be a small increase or decrease in rates depending on
each beneficiary's specific situation. We reiterate that outlier
payments could provide payment to HHAs for those patients with higher
resource use and that the patient's condition does not need to improve
for home health services to be covered by Medicare. We appreciate the
feedback we have received from the public on the outlier policy under
the HH PPS and look forward to ongoing collaboration with stakeholders
on any further refinements that may be warranted, including the
proposed outlier methodology under the PDGM.
Final Decision: We are finalizing our proposal to maintain the
current methodology for payment of high-cost outliers upon
implementation of the PGDM and that we would calculate payment for
high-cost outliers based upon 30-day periods of care.
13. Conforming Regulations Text Revisions for the Implementation of the
PDGM in CY 2020
We are finalizing a number of revisions to the regulations to
implement the PDGM for periods of care beginning on or after January 1,
2020, as outlined in sections through III.F.1 through III.F.12 of this
final rule with comment period. We are finalizing to make conforming
changes in Sec. 409.43 and part 484 Subpart E to revise the unit of
service from a 60-day episode to a 30-day period. In addition, we are
finalizing to restructure Sec. 484.205. These revisions would be
effective on January 1, 2020. Specifically, we are- doing the
following:
Revising Sec. 409.43, which outlines plan of care
requirements. We are revising several paragraphs to phase out the unit
of service from a 60-day episode for claims beginning on or before
December 31, 2019, and to implement a 30-day period as the new unit of
service for claims beginning on or after January 1, 2020 under the
PDGM. We are moving and revising paragraph (c)(2) to Sec. 484.205 as
paragraph (c)(2) aligns more closely with the regulations addressing
the basis of payment.
Revising the definitions of rural area and urban area in
Sec. 484.202 to remove ``with respect to home health episodes ending
on or after January 1, 2006'' from each definition as this verbiage is
no longer necessary.
Restructuring Sec. 484.205 to provide more logical
organization and revise to account for the change in the unit of
payment under the HH PPS for CY 2020. The PDGM uses 30-day periods
rather than the 60-day episode used in the current payment system.
Therefore, we are to revising Sec. 484.205 to remove references to
``60-day episode'' and to refer more generally to the ``national,
standardized prospective payment''. We are also revising Sec. 484.205
as follows:
++ Adding paragraphs to paragraph (b) to define the unit of
payment.
++ Moving language which addresses the requirement for OASIS
submission from Sec. 484.210 and inserting it into Sec. 484.205 as
new paragraph (c).
++ Moving paragraph (c)(2) from Sec. 409.43 to Sec. 484.205 as
new paragraph (g) in order to better align with the regulations
detailing the basis of payment.
++ Adding paragraph (h) to discuss split percentage payments under
the current model and the PDGM.
We are not changing the requirements or policies relating to
durable medical equipment or furnishing negative pressure wound therapy
using a disposable device.
Removing Sec. 484.210 which discusses data used for the
calculation of the national prospective 60-day episode payment as we
believe that this information is duplicative and already incorporated
in other sections of part 484, subpart E.
Revising the section heading of Sec. 484.215 from
``Initial establishment of the calculation of the national 60-day
episode payment'' to ``Initial establishment of the calculation of the
national, standardized prospective 60-day episode payment and 30-day
payment rates.'' Also, we are adding paragraph (f) to this section to
describe when the national, standardized prospective 30-day payment
rate applies.
Revising the section heading of Sec. 484.220 from
``Calculation of the adjusted national prospective 60-day episode
payment rate for case-mix and area wage levels'' to ``Calculation of
the case-mix and wage area adjusted prospective payment rates.'' We are
removing the reference to ``national 60-day episode payment rate'' and
replacing it with ``national, standardized prospective payment''.
Revising the section heading in Sec. 484.225 from
``Annual update of the unadjusted national prospective 60-day
[[Page 56522]]
episode payment rate'' to ``Annual update of the unadjusted national,
standardized prospective 60-day episode and 30-day payment rates''.
Also, we are revising Sec. 484.225 to remove references to ``60-day
episode'' and to refer more generally to the ``national, standardized
prospective payment''. In addition, we are adding paragraph (d) to
describe the annual update for CY 2020 and subsequent calendar years.
Revising the section heading of Sec. 484.230 from
``Methodology used for the calculation of low-utilization payment
adjustment'' to ``Low utilization payment adjustment''. Also, we are
designating the current text to paragraph (a) and inserting language
such that paragraph (a) applies to claims beginning on or before
December 31, 2019, using the current payment system. We are adding
paragraph (b) to describe how low utilization payment adjustments are
determined for claims beginning on or after January 1, 2020, using the
PDGM.
Revising the section heading of Sec. 484.235 from
``Methodology used for the calculation of partial episode payment
adjustments'' to ``Partial payment adjustments''. We are removing
paragraphs (a), (b), and (c). We are removing paragraphs (1), (2), and
(3) which describe partial payment adjustments from paragraph (d) in
Sec. 484.205 and incorporating them into Sec. 484.235. We are adding
paragraph (a) to describe partial payment adjustments under the current
system, that is, for claims beginning on or before December 31, 2019,
and paragraph (b) to describe partial payment adjustments under the
PDGM, that is, for claims beginning on or after January 1, 2020.
Revising the section heading for Sec. 484.240 from
``Methodology used for the calculation of the outlier payment'' to
``Outlier payments.'' In addition, we are removing language at
paragraph (b) and appending it to paragraph (a). We are adding language
to revised paragraph (a) such that paragraph (a) will apply to payments
under the current system, that is, for claims beginning on or before
December 31, 2019. We are revising paragraph (b) to describe payments
under the PDGM, that is, for claims beginning on or after January 1,
2020. In paragraph (c), we are replacing the ``estimated'' cost with
``imputed'' cost. Lastly, we are revising paragraph (d) to reflect the
per-15 minute unit approach to imputing the cost for each claim.
We did not receive any comments on the corresponding regulations
text changes regarding the PDGM; therefore, we are finalizing
regulations text changes as proposed without modification.
G. Changes Regarding Certifying and Recertifying Patient Eligibility
for Medicare Home Health Services
1. Regulations Text Changes Regarding Information Used To Satisfy
Documentation of Medicare Eligibility for Home Health Services
Section 51002 of the BBA of 2018 amended sections 1814(a) and
1835(a) of the Act to provide that, effective for physician
certifications and recertifications made on or after January 1, 2019,
in addition to using the documentation in the medical record of the
certifying physician or of the acute or post-acute care facility (where
home health services were furnished to an individual who was directly
admitted to the HHA from such facility), the Secretary may use
documentation in the medical record of the HHA as supporting material,
as appropriate to the case involved. We believe the BBA of 2018
provisions are consistent with our existing policy in this area, which
is currently reflected in sub-regulatory guidance in the Medicare
Benefit Policy Manual (Pub. 100-02, chapter 7, section 30.5.1.2),\31\
and the Medicare Program Integrity Manual (Pub. 100-08, chapter 6
section 6.2.3).\32\ The subregulatory guidance describes the
circumstances in which HHA documentation can be used along with the
certifying physician and/or acute/post-acute care facility medical
record to support the patient's homebound status and skilled need.
Specifically, we state that information from the HHA, such as the plan
of care required in accordance with Sec. 409.43, and/or the initial
and/or comprehensive assessment of the patient required in accordance
with Sec. 484.55, can be incorporated into the certifying physician's
medical record for the patient and used to support the patient's
homebound status and need for skilled care.
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\31\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c07.pdf.
\32\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c06.pdf.
---------------------------------------------------------------------------
In the CY 2019 HH PPS proposed rule, we proposed to amend the
regulations text at Sec. 424.22(c) to align the regulations text with
current sub-regulatory guidance that allows medical record
documentation from the HHA to be used to support the basis for
certification and/or recertification of home health eligibility, if the
following requirements are met:
The documentation from the HHA can be corroborated by
other medical record entries in the certifying physician's and/or the
acute/post-acute care facility's medical record for the patient,
thereby creating a clinically consistent picture that the patient is
eligible for Medicare home health services as specified in Sec.
424.22(a)(1) and (b).
The certifying physician signs and dates the HHA
documentation demonstrating that the documentation from the HHA was
considered when certifying patient eligibility for Medicare home health
services. HHA documentation can include, but is not limited to, the
patient's plan of care required in accordance with Sec. 409.43 and/or
the initial and/or comprehensive assessment of the patient required in
accordance with Sec. 484.55.
HHAs have the discretion to determine the type and format of any
documentation used to support home health eligibility. Anecdotally, we
have received reports from HHAs that they typically include this
supporting information on the plan of care. In accordance with Sec.
409.43(c)(3), the plan of care must be signed by the physician before
the HHA submits its final claim for payment. In the CY 2019 HH PPS
proposed rule, we stated that because existing sub-regulatory guidance
allows HHA-generated documentation to be used as supporting material
for the physician's determination of eligibility for home health
services, we expect that most HHAs already have a process in place to
provide this information to the certifying physician or the acute/post-
acute care facility. We solicited comments on the proposal to amend the
regulations at Sec. 424.22(c) to align the regulations text with
current sub-regulatory guidance to allow medical record documentation
from the HHA to be used to support the basis for certification and/or
recertification of home health eligibility under certain conditions and
the comments received are summarized in this final rule with comment
period.
Comment: Overall, commenters were supportive of incorporating
existing sub-regulatory guidance into regulations text as it provides
them with reassurance that HHA-generated documentation can play an
important role in confirming eligibility for Medicare home health
services.
Response: We appreciate commenter support about aligning
regulations text with existing regulatory guidance. The goal of this
proposal is to be flexible to allow HHA-generated documentation to
support eligibility for home health services given that the home health
[[Page 56523]]
CoPs at Sec. 484.55 require that the HHA must verify the patient's
eligibility for the Medicare home health benefit, including homebound
status, both at the time of the initial assessment visit and at the
time of the comprehensive assessment. We agree that this proposal
incorporates existing subregulatory flexibilities into the regulations
text that allow HHA medical record documentation to support the basis
of home health eligibility. By incorporating the existing sub-
regulatory guidance into regulation, HHAs are assured that HHA-
generated documentation can be used as supporting material for the
basis of home health eligibility, as long as all conditions are met.
However, we remind commenters that the certifying physician's and/or
the acute/post-acute care facility's medical record (if the patient was
directly admitted to home health from such setting) for the patient
must contain sufficient documentation of the patient's medical
condition(s) to substantiate eligibility for home health services. The
information may include, but is not limited to, such factors as the
patient's diagnosis, duration of the patient's condition, clinical
course (worsening or improvement), prognosis, nature and extent of
functional limitations, other therapeutic interventions and results,
etc. The certifying physician's and/or the acute/post-acute care
facility's medical records can always stand alone in substantiating
eligibility for home health services. Similarly, the certifying
physician's/acute/post-acute care facility's medical record, in
conjunction with appropriately incorporated HHA documentation (for
example, plan of care, OASIS, etc.), may also substantiate the
patient's eligibility for home health services. However, HHA-generated
medical record documentation for the patient, by itself, is not
sufficient in demonstrating the patient's eligibility for Medicare home
health services. As noted earlier, in accordance with Sec. 424.22(a)
and (c), it is the patient's medical record held by the certifying
physician and/or the acute/post-acute care facility that must support
the patient's eligibility for home health services. Therefore, any
documentation used to support certification that was generated by the
HHA must be signed off by the certifying physician and incorporated
into his/her medical record. The information provided to the certifying
physician by the HHA and incorporated into the patient's medical record
must be corroborated by the rest of the patient's medical record. This
means that the HHA information, along with the certifying physician's
and/or the acute/post-acute care facility's medical record, creates a
clinically consistent picture that the patient is eligible for Medicare
home health services. This could include, but is not limited to, the
plan of care required in accordance with Sec. 409.43, the initial and/
or the comprehensive assessment of the patient required in accordance
with Sec. 484.55, the inpatient discharge summary, or multi-
disciplinary clinical notes, etc., which must correspond to the dates
of service being billed and not contradict the certifying physician's
and/or the acute/post-acute care facility's own documentation or
medical record entries. Once incorporated into the certifying
physician's medical record for the patient, the HHA information can be
used to support the patient's homebound status and need for skilled
care.
Comment: A commenter expressed concern that this proposal would
allow HHAs to have too much control over Medicare coverage decisions
and provides an opportunity for the HHA to override the physician's
opinion. This commenter went on to state that there may be a
physician's order for care that subsequently has been reduced or
discontinued by the HHA and that beneficiaries are forced to settle for
less care for fear that the HHA will not provide any services at all.
This same commenter stated that certifying physicians are busy and do
not have the time to read hundreds of detailed home health agency
records. This commenter recommended that the HHA-generated
documentation should be used only to confirm eligibility and not to
deny coverage for patients that home health agencies no longer want to
serve.
Response: We note that coverage of Medicare home health services is
dependent upon beneficiary eligibility for Medicare home health
services as set forth at Sec. 409.42. We remind commenters that the
HHA-generated documentation may only be used to support the certifying
physician and/or the acute/post-acute care facility's medical record
documentation for eligibility for Medicare home health services. As
such, the HHA-generated documentation is not meant to supersede,
override or negate the physician's opinion or any physician orders in
the established home health plan of care. The HHA-generated
documentation is only meant to augment, as necessary, the certifying
physician's and/or acute/post-acute care facility's medical
documentation to create a clinically consistent picture that the
patient is eligible for home health services. Any HHA-generated
information provided to the certifying physician by the HHA and
incorporated into the patient's medical record held by the certifying
physician and/or the acute/post-acute care facility's medical record
(if the patient was directly admitted to home health for such setting)
must be corroborated by the rest of the patient's medical record. As
such, we do not expect that HHAs would need to send voluminous clinical
records to a certifying physician for his/her review when certifying a
patient for home health eligibility as the certifying physician's and/
or the acute/post-acute care facility's medical records are required to
have sufficient information to serve as the basis for home health
eligibility. Additionally, the certifying physician is responsible for
establishing and periodically reviewing the home health plan of care in
accordance with the home health CoPs at 42 CFR 484.60(a)(1). While the
HHA is responsible for coordinating with the certifying physician
regarding any revisions to the home health plan of care, drugs,
services, and treatments are administered only as ordered by a
physician. Therefore, it would be a violation of the home health CoPs
for a HHA to revise the plan of care, including reducing or
discontinuing any items or services identified on the plan of care,
without specific orders from the certifying physician. Finally, the
purpose of the supporting documentation is to confirm eligibility for
Medicare home health services. However, if the certifying physician's
and/or acute/post-acute care facility's documentation and the HHA-
generated incorporated supporting documentation do not create a
clinically consistent picture that the individual is eligible for
Medicare home health services (for example, the individual is homebound
and requires skilled services), this would not meet the requirements
for coverage.
Comment: Another commenter asked if the certifying physician is
required to sign every page of HHA-generated supporting documentation
to demonstrate that the documentation from the HHA was considered when
certifying patient eligibility for Medicare home health services.
Response: There are no specific regulations regarding physician
signature on a document with multiple pages. In accordance with Sec.
484.110(b) of our regulations, all patient medical record entries must
be legible, complete, dated, timed, and authenticated in written or
electronic form by the person responsible for providing or evaluating
the service provided. Only when it is clear that an individual document
[[Page 56524]]
extends to multiple pages (for example, a notation on a multi-page
document that identifies pagination--``page 2 of 4''), and that the
entire document is then authenticated, would a signature on a single
page suffice for other pages as well.\33\ However, we recognize that
there may be multiple variations in the way HHA documentation is
incorporated into the certifying physician's and/or acute/post-acute
care facility's medical records. As such, we will provide future sub-
regulatory guidance to address any identified variations. We believe
this will provide additional clarity for HHAs and decrease the
likelihood that inconsistent decisions would be made by appeals
adjudicators regarding certification of patient eligibility for home
health services.
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\33\ See, https://med.noridianmedicare.com/web/jfb/cert-reviews/signature-requirement-q-a.
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Comment: A commenter suggested that CMS should clarify that the
patient's plan of care, with sufficient information to support
eligibility and signed by the certifying physician, may be used as
documentation from the physician's medical record to support
eligibility for home health services. This commenter stated that CMS
might consider revising the regulatory text at 42 CFR 424.22(c) to
read:
``. . . . documentation can include, but is not limited to, the
patient's plan of care and/or the initial or the comprehensive
assessment''.
Response: We agree with this commenter's suggestion given we stated
in the preamble of the CY 2019 HH PPS proposed rule that information
from the HHA, such as the plan of care required in accordance with
Sec. 409.43 and/or the initial and/or comprehensive assessment of the
patient required in accordance with Sec. 484.55, can be incorporated
into the certifying physician's medical record for the patient and used
to support the patient's homebound status and need for skilled care. We
also agree the patient's plan of care could be the sole HHA
documentation that is incorporated into the certifying physician's and/
or the acute/post-acute care facility's medical record for the patient
and used to support the basis for certification of home health
eligibility if the plan of care provides sufficient information to
support eligibility. We remind commenters that the CoPs at Sec. 484.60
provide the content requirements for the plan of care including all
pertinent diagnoses and functional limitations. Likewise, we remind
commenters that the certifying physician's and/or the acute/post-acute
care facility's medical documentation shall be used as the basis for
home health eligibility. The documentation from the HHA serves only as
supporting documentation for the purposes of certification if
incorporated into the certifying physician's and/or the acute/post-
acute care facility's medical record for the patient. We will revise
the regulatory text at Sec. 424.22(c) accordingly to reflect
commenters' concerns.
Final Decision: We are finalizing the proposal to amend the
regulations text at Sec. 424.22(c) to align with current subregulatory
guidance to allow medical record documentation from the HHA to be used
to support the basis for certification and/or recertification of home
health eligibility, if the certain requirements are met as previously
described.
2. Elimination of Recertification Requirement To Estimate How Much
Longer Home Health Services Will Be Required
In the CY 2018 HH PPS proposed rule (82 FR 35378), we invited
public comments about improvements that can be made to the health care
delivery system that reduce unnecessary burdens for clinicians, other
providers, and patients and their families. Specifically, we asked the
public to submit their ideas for regulatory, sub-regulatory, policy,
practice, and procedural changes to reduce burdens for hospitals,
physicians, and patients, improve the quality of care, decrease costs,
and ensure that patients and their providers and physicians are making
the best health care choices possible.
Several commenters requested that CMS consider eliminating the
requirement that the certifying physician include an estimate of how
much longer skilled services will be required at each home health
recertification, as set forth at Sec. 424.22(b)(2) and in sub-
regulatory guidance in the Medicare Benefit Policy Manual (Chapter 7,
Section 30.5.2). Commenters stated that this estimate is duplicative of
the Home Health CoP requirements for the content of the home health
plan of care, set out at Sec. 484.60(a)(2).
We determined that the estimate of how much longer skilled care
will be required at each recertification is not currently used for
quality, payment, or program integrity purposes. Given this
consideration and the existing home health CoP requirements for the
content of the home health plan of care, in the CY 2019 HH PPS proposed
rule we proposed to eliminate the regulatory requirement, as set forth
at Sec. 424.22(b)(2), that the certifying physician, as part of the
recertification statement, provide an estimate of how much longer
skilled services will be required (83 FR 32424). All other
recertification content requirements under Sec. 424.22(b)(2) would
remain unchanged. We noted that the elimination of this recertification
requirement would result in a reduction of burden for certifying
physicians by reducing the amount of time physicians spend on the
recertification process, resulting in an overall cost savings of $14.2
million. We provide a description of this burden reduction in section
X.C.1.c. of this final rule with comment period.
We solicited comments regarding the proposed elimination of the
requirement that the certifying physician include an estimate of how
much longer skilled services will be required at each home health
recertification, as well as the corresponding regulations text changes
at Sec. 424.22(b)(2).
Comment: Commenters overwhelmingly supported this proposal.
Commenters stated that the elimination of this requirement would help
to streamline documentation and make it easier for agencies to obtain
necessary information from supervising physicians in a timely manner.
Commenters also remarked that removing this requirement will also be
consistent with the ``Patients over Paperwork'' initiative. Other
commenters remarked that this would allow certifying physicians to
focus more time on patient care.
Response: We appreciate commenter support on this proposal and we
agree that elimination of this recertification requirement would reduce
the amount of time certifying physicians would spend reviewing medical
documentation. This change would reduce the time spent by physicians
for recertification without diminishing existing documentation
requirements and will allow greater emphasis to be placed on patient
care.
Final Decision: Effective for recertifications made on and after
January 1, 2019, we are finalizing our proposal to eliminate the
regulatory requirement set forth at Sec. 424.22(b)(2) that requires
the certifying physician, as part of the recertification process, to
provide an estimate of how much longer skilled services will be
required. All other recertification content requirements under Sec.
424.22(b)(2) would remain unchanged.
[[Page 56525]]
H. Change Regarding Remote Patient Monitoring Under the Medicare Home
Health Benefit
In the CY 2019 HH PPS proposed rule (83 FR 32425), we acknowledged
the potential benefit of the use of remote patient monitoring to
augment the home health plan of care. We discussed how remote patient
monitoring could enable the HHA to more quickly identify any changes in
the patient's clinical condition, prompting physician review of, and
potential changes to, the plan of care. For example, in cases where the
home health patient is admitted for skilled observation and assessment
of the patient's condition due to a reasonable potential for
complications or an acute episode, remote patient monitoring could
augment home health visits until the patient's clinical condition
stabilized. Fluctuating or abnormal vital signs could be monitored
between visits, potentially leading to quicker interventions and
updates to the treatment plan. Additionally, we discussed findings of
our literature review that revealed that remote patient monitoring may
improve patients' ability to maintain independence, improving their
quality of life. Particularly for patients with chronic obstructive
pulmonary disease (COPD) and congestive heart failure (CHF), research
indicates that remote patient monitoring has been successful in
reducing readmissions and long-term acute care utilization.\34\ Other
benefits included fewer complications and decreased costs.
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\34\ Broad, J., Davis, C., Bender, M., Smith, T. (2014)
Feasibility and Acute Care Utilization Outcomes of a Post-Acute
Transitional Telemonitoring Program for Underserved Chronic Disease
Patients. Journal of Cardiac Failure. Vol 20 (8S) S116. http://dx.doi.org/10.1016/j.cardfail.2014.06.328.
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We explained that although section 1895(e)(1)(A) of the Act
prohibits payment for services furnished via a telecommunications
system if such services substitute for in-person home health services
ordered as part of a plan of care, the statute does not define the term
``telecommunications system'' as it relates to the provision of home
health care. While a service using a form of telecommunications, remote
patient monitoring is not considered a Medicare telehealth service as
defined under section 1834(m) of the Act. Additionally, there is no
direct interaction between the patient and the practitioner. Remote
monitoring, rather uses digital technology to relay information
captured by the patient to the practitioner for review, and to
potentially prompt changes to the plan of care. We explained that for
these reasons it would not be subject to the telehealth restrictions on
originating site and interactive telecommunications systems technology
under section 1834(m) of the Act.
Therefore, because the statute does not define the term
``telecommunications system'' as it relates to the provision of home
health care, we proposed to define remote patient monitoring in
regulation under the Medicare home health benefit as ``the collection
of physiologic data (for example, ECG, blood pressure, glucose
monitoring) digitally stored and/or transmitted by the patient and/or
caregiver to the HHA.'' This definition aligns with the description for
CPT code 99091, which allows physicians and other healthcare
professionals to bill for the collection and interpretation of
physiologic data digitally stored and/or transmitted by the patient
and/or caregiver to the physician or other qualified health care
professional (82 CFR 53013). We recognized that HHAs cannot bill for
this code (CPT code 99091); however, we believe the code's description
accurately describes remote monitoring services. We also noted that CPT
code 99091 includes the interpretation of the physiologic data, whereas
the HHA would only be responsible for the collection of the data.
Currently home health costs associated with remote patient
monitoring are reported on line 23.20 on Worksheet A as direct costs
associated with telemedicine. For 2016, approximately 3 percent of HHAs
reported telemedicine costs that accounted for roughly 1 percent of
their total agency costs on the HHA cost report. However, these costs
are not allocated to the costs per visit. Allowing HHAs to report the
costs of remote patient monitoring on the HHA cost report as part of
their operating expenses, which are factored into the costs per visit,
would have important implications for assessing home health costs
relevant to payment, including HHA Medicare margin calculations.
Therefore, we proposed to amend the regulations at 42 CFR 409.46 to
include the costs of remote patient monitoring as an allowable
administrative cost (that is, operating expense), if remote patient
monitoring is used by the HHA to augment the care planning process.
We solicited comments on the proposed regulatory definition of
remote patient monitoring under the HH PPS to describe
telecommunication services used to augment the plan of care during a
home health episode. Additionally, we welcomed comments regarding
additional utilization of telecommunications technologies for
consideration in future rulemaking. We also solicited comments on the
proposed changes to the regulations at 42 CFR 409.46, to include the
costs of remote patient monitoring as allowable administrative costs
(that is, operating expenses) on the HHA cost report. The following is
a summary of the public comments received and our responses.
Comment: Comments regarding the proposal to define remote patient
monitoring in regulation for the Medicare home health benefit and to
include the costs of remote patient monitoring as an allowable expense
on the HHA cost report were overwhelmingly positive. Commenters stated
that there are multiple benefits to integrating the costs of remote
patient monitoring into home health, including providing clinicians
with real-time updates on patient condition and providing patients with
timely feedback, thereby encouraging patient engagement. Additionally,
commenters stated that it allows for greater involvement with nurses
and physicians, while decreasing travel, which may be advantageous not
only in rural areas, but urban areas as well.
Response: We thank commenters for their positive feedback regarding
these proposals. We agree that there are many benefits to remote
patient monitoring and anticipate that defining it in regulation and
allowing for more clear analysis of the associated costs through the
cost report will encourage its use in home health and have a positive
effect on patient outcomes.
Comment: Several commenters encouraged CMS to monitor utilization
patterns to ensure that remote patient monitoring is not being used as
a substitute for face-to-face visits. A commenter suggested that CMS
require information about the frequency and duration of the use of
remote patient monitoring services; specifically, that the HHA be
required to report on the Medicare claim whether an episode included
the use of remote patient monitoring.
Response: We agree with the recommendation to monitor utilization
patterns to ensure appropriate use of the service under the home health
benefit. We also agree that data concerning whether individuals
received remote patient monitoring during the 30-day period of care
could be informative. We will consider ways to obtain this information
in the future.
Comment: Another commenter suggested that CMS clarify that if the
remote monitoring service is a nursing service, it can help satisfy the
skilled nursing requirement to trigger Medicare
[[Page 56526]]
coverage for other covered home health services such as home health
aides and occupational therapy.
Response: In accordance with section 1861(m) of the Act, home
health services must be furnished in the beneficiary's home.
Additionally, Sec. 409.48 defines a visit as an episode of personal
contact with the beneficiary by staff of the HHA or others under
arrangements with the HHA, for the purpose of providing a covered
service. Finally, section 1895(e)(1)(B) of the Act states that services
furnished via a telecommunications systems are not considered home
health visits for purposes of eligibility or payment. Therefore, we do
not consider the use of remote patient monitoring alone and/or a visit
solely for the purpose of setting up and/or training the patient on
remote monitoring equipment to meet the criteria for prompting coverage
of home health services under the Medicare home health benefit.
Comment: Several commenters suggested adding the descriptions of
two new proposed Physician Fee Schedule CPT codes: CPT codes 990X0,
set-up and patient education on use of equipment and 990X1, device
supply with daily recordings or programmed alerts transmission, to the
proposed home health definition in order to allow for a more
appropriate and complete description of allowable costs for remote
patient monitoring services in the home health setting. Commenters
suggested this would also help to establish consistency regarding
remote patient monitoring across Medicare sites of service.
Response: We recognize that the descriptors for these two codes
allows for greater specificity of the process of remote patient
monitoring, which in turn would lead to more accurate analysis of the
associated costs. While the proposed home health regulations text at
Sec. 409.46(e) would permit the cost and service of the equipment to
be allowable administrative costs, we agree that set-up and patient
education should be allowable expenses reported on the cost report.
However, we wish to clarify that a visit to set up and/or train the
patient on the equipment would not be allowed on the HHA claim when no
other skilled service is provided. In other words, a visit cannot be
reported when the sole reason is to set up and/or train the patient on
the use of the remote monitoring equipment. Therefore, we are adding
language to the regulations text to ensure a more complete description
of remote patient monitoring services, with the qualification that such
set-up and patient education services cannot be reported as a visit
without the provision of another skilled service.
Comment: A commenter recommended that CMS describe how it plans to
account for the adoption of new remote patient monitoring services as
the agency monitors and evaluates the impact of previous or future
rebasing adjustments made to the home health prospective payment rates
since 2014. Another commenter stated that in order to implement in an
effective and consistent manner, CMS needs to develop an appropriate
corresponding payment methodology. Other commenters suggested CMS set
up a demonstration project where HHAs have an incentive to make an
investment in technologies, or incorporate telehealth waivers into all
demonstration projects. Other commenters stated that CMS should have a
more broad approach to telehealth and telemedicine to include virtual
visits as a potential strategy to address workforce challenges. Others
stated CMS should directly reimburse for remote patient monitoring,
perhaps as a non-routine supply for agencies who are actually providing
the service, as the proposal will indirectly provide increased
reimbursement for all agencies, not specifically for those providing
the service.
Response: We appreciate the commenters' suggestions. While we
understand that these comments indicate that some commenters would like
to see additional activities in incentivizing the use of remote patient
monitoring in home health, we believe that allowing the costs
associated with remote patient monitoring to be reported on the cost
report is a necessary first step in determining the cost and frequency
in which HHAs are currently utilizing this technology and whether the
use of such technology improves health outcomes for home health
patients. Additionally, we reiterate that 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 plan to closely monitor remote patient monitoring
costs and the impact that such technology may have on patient outcomes
under the traditional Medicare home health benefit and we will consider
ways to more broadly support such technology as part of home health.
Comment: A commenter suggested that rather than allowing the costs
of remote patient monitoring to be included on the home health cost
report, remote patient monitoring should be excluded from the home
health episode and provided as a distinct and separately reimbursed
service. The commenter stated that this would recognize the value of
remote patient monitoring services while also recognizing home health
agencies as providers of these services. Home health agencies would
then be able to provide these services to patients within home health
but also to those who do not qualify for home health but would benefit
from RPM services, despite not having a mechanism for reimbursement.
Similarly, another commenter suggested that a telehealth chronic care
management program conceptualized as a ``step down'' program from an
episode of care would benefit many patients greatly and may serve as an
alternative to successive full episodes of care.
Response: We thank the commenters for these suggestions; however,
we believe that these comments suggest the implementation of a separate
remote patient monitoring benefit under Medicare and are therefore
outside of the scope of this rule. Additionally, we note that beginning
in CY 2018, separate payment is made under the Physician Fee Schedule
for CPT code 99091 (Collection and interpretation of physiologic data
(for example., ECG, blood pressure, glucose monitoring) digitally
stored and/or transmitted by the patient and/or caregiver to the
physician or other qualified health care professional). This code,
billed directly by a practitioner, allow remote patient monitoring to
be provided outside of the home health benefit for non-homebound
patients.
Comment: Several commenters requested that CMS clarify whether the
agency intends that all qualified health professionals, specifically
physical therapists, speech language pathologists, and occupational
therapists, acting within their scope of practice, may use remote
patient monitoring to augment the plan of care during a home health
episode.
Response: Our definition does not specify which skilled
professionals may utilize remote patient monitoring under home health.
As therapy goals must be established by a qualified therapist in
conjunction with the physician when determining the plan of care, we
believe therapists involved in care planning, as well as other skilled
professionals acting within their scope of practice, may utilize remote
patient monitoring to augment this process.
Final decision: We are finalizing our proposal to define remote
patient
[[Page 56527]]
monitoring under the Medicare home health benefit as ``the collection
of physiologic data (for example, ECG, blood pressure, glucose
monitoring) digitally stored and/or transmitted by the patient or
caregiver or both to the home health agency.'' We are adding the
following language to the regulations text to ensure a more complete
description of remote patient monitoring services, while also ensuring
that such services cannot be reported as a visit without the provision
of another skilled service: Visits to a beneficiary's home for the sole
purpose of supplying, connecting, and/or training the patient on the
remote patient monitoring equipment, without the provision of another
skilled service are not separately billable. These services do
constitute services included in the expense of providing remote patient
monitoring allowed as administrative costs.
Additionally, we are finalizing our proposal to amend the
regulations at 42 CFR 409.46 to include the costs of remote patient
monitoring as an allowable administrative cost (that is, operating
expense), if remote patient monitoring is used by the HHA to augment
the care planning process.
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), 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 (competing HHAs) are required to
compete in the Model. Requiring all Medicare-certified HHAs providing
services in the selected states to participate in the Model ensures
that: (1) There is no selection bias; (2) participating HHAs are
representative of HHAs nationally; and (3) there is sufficient
participation to generate meaningful results.
As finalized in the CY 2016 HH PPS final rule, 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 beginning in CY
2018 based on the competing HHAs' performance on applicable measures.
Payment adjustments will be increased incrementally over the course of
the HHVBP Model in the following manner: (1) A maximum payment
adjustment of 3 percent (upward or downward) in CY 2018; (2) a maximum
payment adjustment of 5 percent (upward or downward) in CY 2019; (3) a
maximum payment adjustment of 6 percent (upward or downward) in CY
2020; (4) a maximum payment adjustment of 7 percent (upward or
downward) in CY 2021; and (5) a maximum payment adjustment of 8 percent
(upward or downward) in CY 2022. Payment adjustments are based on each
HHA's Total Performance Score (TPS) in a given performance year (PY)
comprised of: (1) A set of measures already reported via the Outcome
and Assessment Information Set (OASIS) and completed Home Health
Consumer Assessment of Healthcare Providers and Systems (HHCAHPS)
surveys for all patients serviced by the HHA and select claims data
elements; and (2) three New Measures for which points are achieved for
reporting data.
For CY 2019 (83 FR 32426), we proposed to remove five measures and
add two new proposed composite measures to the applicable measure set
for the HHVBP model, revise our weighting methodology for the measures,
and rescore the maximum number of improvement points.
B. Quality Measures
1. Removal of Two OASIS-Based Measures Beginning With Performance Year
4 (CY 2019)
In the CY 2016 HH PPS final rule, we finalized a set of quality
measures in Figure 4a: Final PY1 Measures and Figure 4b: Final PY1 New
Measures (80 FR 68671 through 68673) for the HHVBP Model to be used in
PY1, referred to as the starter set. We also stated that this set of
measures will be subject to change or retirement during subsequent
model years and revised through the rulemaking process (80 FR 68669).
The measures were selected for the Model using the following
guiding principles: (1) Use a broad measure set that captures the
complexity of the services HHAs provide; (2) incorporate flexibility
for future inclusion of the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT) measures that cut across post-acute
care settings; (3) develop `second generation' (of the HHVBP Model)
measures of patient outcomes, health and functional status, shared
decision making, and patient activation; (4) include a balance of
process, outcome and patient experience measures; (5) advance the
ability to measure cost and value; (6) add measures for appropriateness
or overuse; and (7) promote infrastructure investments. This set of
quality measures encompasses the multiple National Quality Strategy
(NQS) domains \35\ (80 FR 68668). The NQS domains include six priority
areas identified in the CY 2016 HH PPS final rule (80 FR 68668) as the
CMS Framework for Quality Measurement Mapping. These areas are: (1)
Clinical quality of care; (2) Care coordination; (3) Population &
community health; (4) Person- and Caregiver-centered experience and
outcomes; (5) Safety; and (6) Efficiency and cost reduction. Figures 4a
and 4b of the CY 2016 HH PPS final rule identified 15 outcome measures
(five from the HHCAHPS, eight from OASIS, and two claims-based
measures), and nine process measures (six from OASIS, and three New
Measures, which were not previously reported in the home health
setting) for use in the Model.
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\35\ 2015 Annual Report to Congress, http://www.ahrq.gov/workingforquality/reports/annual-reports/nqs2015annlrpt.htm.
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In the CY 2017 HH PPS final rule, we removed four measures from the
measure set for PY1 and subsequent performance years: (1) Care
Management: Types and Sources of Assistance; (2) Prior Functioning ADL/
IADL; (3) Influenza Vaccine Data Collection Period: Does this episode
of care include any dates on or between October 1 and March 31?; and
(4) Reason Pneumococcal Vaccine Not Received, for the reasons discussed
in that final rule (81 FR 76743 through 76747).
In the CY 2018 HH PPS final rule, we removed the OASIS-based
measure, Drug Education on All Medications Provided to Patient/
Caregiver during All Episodes of Care, from the set of applicable
measures beginning with PY3 for the reasons discussed in that final
rule (82 FR 51703 through 51704).
For PY4 and subsequent performance years, we proposed (83 FR 32426
through 32427) to remove two OASIS-based process measures, Influenza
Immunization Received for Current Flu
[[Page 56528]]
Season and Pneumococcal Polysaccharide Vaccine Ever Received, from the
set of applicable measures. We adopted the Influenza Immunization
Received for Current Flu Season measure beginning PY1 of the model.
Since that time, we have received input from both stakeholders and a
Technical Expert Panel (TEP) convened by our contractor in 2017 that
because the measure does not exclude HHA patients who were offered the
vaccine but declined it and patients who were ineligible to receive it
due to contraindications, the measure may not fully capture HHA
performance in the administration of the influenza vaccine. In response
to these concerns, we proposed to remove the measure from the
applicable measure set beginning PY4.
We also adopted the Pneumococcal Polysaccharide Vaccine Ever
Received measure beginning PY1 of the model. This process measure
reports the percentage of HH episodes during which patients were
determined to have ever received the Pneumococcal Polysaccharide
Vaccine. The measure is based on guidelines previously issued by the
Advisory Committee on Immunization Practices (ACIP),\36\ which
recommended use of a single dose of the 23-valent pneumococcal
polysaccharide vaccine (PPSV23) among all adults aged 65 years and
older and those adults aged 19-64 years with underlying medical
conditions that put them at greater risk for serious pneumococcal
infection.\37\ In 2014, the ACIP updated its guidelines to recommend
that both vaccines, the PCV13 and the PPSV23, be given to all
immunocompetent adults aged >=65 years.\38\ The recommended intervals
for sequential administration of PCV13 and PPSV23 depend on several
patient factors including: The current age of the adult, whether the
adult had previously received PPSV23, and the age of the adult at the
time of prior PPSV23 vaccination (if applicable). Because the
Pneumococcal Polysaccharide Vaccine Ever Received measure does not
fully reflect the current ACIP guidelines, we proposed to remove this
measure from the model beginning PY4.
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\36\ The Advisory Committee on Immunization Practices was
established under Section 222 of the Public Health Service Act (42
U.S.C. 217a), as amended, to assist states and their political
subdivisions in the prevention and control of communicable diseases;
to advise the states on matters relating to the preservation and
improvement of the public's health; and to make grants to states
and, in consultation with the state health authorities, to agencies
and political subdivisions of states to assist in meeting the costs
of communicable disease control programs. (Charter of the Advisory
Committee on Immunization Practices, filed April 1, 2018. https://www.cdc.gov/vaccines/acip/committee/ACIP-Charter-2018.pdf).
\37\ Prevention of Pneumococcal Disease: Recommendations of the
Advisory Committee on Immunization Practices (ACIP), MMWR 1997;46:1-
24.
\38\ Tomczyk S, Bennett NM, Stoecker C, et al. Use of 13-valent
pneumococcal conjugate vaccine and 23-valent pneumococcal
polysaccharide vaccine among adults aged >=65 years: recommendations
of the Advisory Committee on Immunization Practices (ACIP). MMWR
2014; 63: 822-5.
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We invited public comment on our proposal to remove these two
OASIS-based measures, Influenza Immunization Received for Current Flu
Season and Pneumococcal Polysaccharide Vaccine Ever Received, from the
set of applicable measures for PY4 and subsequent performance years.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: The majority of commenters supported removing both OASIS-
based process measures, Influenza Immunization Received for Current Flu
Season and Pneumococcal Polysaccharide Vaccine Ever Received, citing
concerns that process measures may be burdensome on providers to report
while yielding limited information to support clinical improvement.
Commenters also noted that removal of the measures aligns with the
Meaningful Measure Initiative. Several commenters opposed any changes
to the HHVBP model's applicable measure set and recommended that CMS
complete testing of the HHVBP model prior to making any changes. A
commenter opposed removal of the Pneumococcal Polysaccharide Vaccine
Ever Received measure, stating that removal may lead to reductions in
pneumococcal immunization rates. The commenter believes that CMS should
retain this measure until it is updated to reflect the most current
ACIP guidelines. The commenter noted that the measure aligned with
Meaningful Measures criteria on high-impact conditions and patient-
centered care, adding that retaining the measure would not be
burdensome to HHAs, given their ability to establish standing orders to
support immunization processes. Another commenter opposed removal of
the Influenza Immunization Received for Current Flu Season measure as
the commenter believes that it is an important safety measure that may
be overlooked if it is no longer required to be reported.
Response: With regard to those comments that opposed changes to the
HHVBP Model's applicable measure set until testing of the Model has
concluded, we reiterate that one of the goals of the Model is to study
new potential quality and efficiency measures for appropriateness in
the home health setting. We indicated in the CY 2016 HH PPS final rule
that the initial set of measures adopted for use in the Model would be
subject to change during subsequent model years and, as summarized
previously and in the proposed rule, we have finalized the removal of
other measures included in the initial measure set in prior rulemaking.
We continue to believe it is important to evaluate and consider changes
to the measure set during the course of testing the Model because the
relevance of certain quality measures may change over time (for
example, a measure may become ``topped out''). We also note that we
attempt to align with other CMS reporting programs, such as the Home
Health Quality Reporting Program (HH QRP), to the extent possible, in
order to minimize HHAs' reporting burden, as well as to focus on
outcome-based measures where possible and align to clinical or best
practice.
With respect to the commenter's concern that removal of the
``Influenza'' measure from the HHVBP model's applicable measure set
would result in the vaccine not being given, we note that while the
purpose of including these measures may be to drive certain outcomes or
processes, such as administering a vaccine, removing the measure from
the HHVBP Model's applicable measure set does not mean that HHAs will
avoid providing appropriate care when needed. Moreover, although the
``Influenza'' measure was removed from the Quality of Patient Care Star
Rating effective April 2018, HHAs will continue to report the measure
in the HH QRP and it will continue to be displayed on Home Health
Compare (HHC). As discussed in the proposed rule, we proposed to remove
this measure from the HHVBP model's applicable measure set in response
to concerns that it may not fully capture HHA performance in the
administration of the influenza vaccine. However, we believe that HHAs
will continue to have an incentive to provide the vaccine where
appropriate.
With respect to the removal of the Pneumococcal Polysaccharide
Vaccine Ever Received measure, we note that CMS is finalizing in this
final rule with comment period the removal of this measure for purposes
of the HH QRP beginning with the CY 2021 HH QRP and will publicly
report the measure on HHC until January 2021. As we discuss in response
to comments in section V. of this final rule with comment period, while
we understand that assessing and appropriately vaccinating patients are
important components of the care
[[Page 56529]]
process, we also prioritize ensuring that quality measures can be used
by practitioners to inform their clinical decision and care planning
activities. The updated ACIP pneumococcal vaccination recommendations
require information that is often not available to HHAs, including
whether the patient has previously been vaccinated, the type of
pneumococcal vaccine received by the patient, as well as the sequencing
of vaccine administration. In addition, the physician issuing orders
and responsible for the home health plan of care may not be the
patient's primary care practitioner or other health care professional
responsible for providing care and services to the patient before and
after discharge from the agency, and therefore may not be best able to
provide the HHA with such information. Finally, even if the
pneumococcal vaccination status of the patient is available, OASIS
Items M1051, Pneumococcal Vaccine and M1056, Reason Pneumococcal
Vaccine not received that are used in the calculation of this measure
do not correspond to the updated ACIP pneumococcal vaccination
recommendations and therefore may not accurately measure HHA
performance in this area. However, we understand and value the role
pneumococcal vaccines play in preventing pneumococcal disease \39\ and
we encourage that, whenever possible and as appropriate, HHAs provide
pneumococcal vaccinations for their patients. As with the influenza
vaccination measure, we do not believe that our removal of this measure
from the HHVBP model will result in HHAs failing to provide appropriate
care for beneficiaries.
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\39\ CDC: Pneumococcal Disease. Retrieved from: http://www.cdc.gov/pneumococcal/about/prevention.html.
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Final Decision: After considering public comments, we are
finalizing as proposed the removal of the Influenza Immunization
Received for Current Flu Season and Pneumococcal Polysaccharide Vaccine
Ever Received measures from the set of applicable measures beginning
with PY4 and subsequent years of the model.
2. Replacement of Three OASIS-Based Measures With Two Composite
Measures Beginning With Performance Year 4
As previously noted, one of the goals of the HHVBP Model is to
study new potential quality and efficiency measures for appropriateness
in the home health setting. In the CY 2018 HH PPS Final Rule, we
solicited comment on additional quality measures for future
consideration in the HHVBP model, specifically a Total Change in ADL/
IADL Peformance by HHA Patients Measure, a Composite Functional Decline
Measure, and behavioral health measures (82 FR 51706 through 51711).
For the reasons discussed in the proposed rule (83 FR 32427 through
32429), we proposed to replace three individual OASIS measures
(Improvement in Bathing, Improvement in Bed Transferring, and
Improvement in Ambulation-Locomotion) with two composite measures:
Total Normalized Composite Change in Self-Care and Total Normalized
Composite Change in Mobility. As we discussed in the CY 2019 HH PPS
proposed rule, these proposed measures use several of the same ADLs as
the composite measures discussed in the CY 2018 HH PPS final rule (82
FR 51707). Our contractor convened a TEP in November 2017, which
supported the use of two composite measures in place of the three
individual measures because HHA performance on the three individual
measures would be combined with HHA performance on six additional ADL
measures to create a more comprehensive assessment of HHA performance
across a broader range of patient ADL outcomes. The TEP also noted that
HHA performance is currently measured based on any change in
improvement in patient status, while the composite measures would
report the magnitude of patient change (either improvement or decline)
across six self-care and three mobility patient outcomes.
We indicated in the proposed rule that there are currently three
ADL improvement measures in the HHVBP Model (Improvement in Bathing,
Improvement in Bed Transferring, and Improvement in Ambulation-
Locomotion). The maximum cumulative score across all three measures is
30. Because we proposed to replace these three measures with the two
composite measures, we also proposed that each of the two composite
measures would have a maximum score of 15 points, to ensure that the
relative weighting of ADL-based measures would stay the same. That is,
there would still be a maximum of 30 points available for ADL-related
measures.
We stated that the proposed Total Normalized Composite Change in
Self-Care and Total Normalized Composite Change in Mobility measures
would represent a new direction in how quality of patient care is
measured in home health. We stated that both of these proposed
composite measures combine several existing and endorsed HH QRP outcome
measures into focused composite measures to enhance quality reporting.
These proposed composite measures fit within the Patient and Family
Engagement \40\ domain as functional status and functional decline are
important to assess for residents in home health settings. Patients who
receive care from an HHA may have functional limitations and may be at
risk for further decline in function because of limited mobility and
ambulation.
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\40\ 2017 Measures under Consideration List. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/2017-CMS-Measurement-Priorities-and-Needs.pdf.
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The proposed Total Normalized Composite Change in Self-Care measure
computes the magnitude of change, either positive or negative, based on
a normalized amount of possible change on each of six OASIS-based
quality outcomes. These six outcomes are as follows:
Improvement in Grooming (M1800)
Improvement in Upper Body Dressing (M1810)
Improvement in Lower Body Dressing (M1820)
Improvement in Bathing (M1830)
Improvement in Toileting Hygiene (M1845)
Improvement in Eating (M1870)
The proposed Total Normalized Composite Change in Mobility measure
computes the magnitude of change, either positive or negative, based on
the normalized amount of possible change on each of three OASIS-based
quality outcomes. These three outcomes are as follows:
Improvement in Toilet Transferring (M1840)
Improvement in Bed Transferring (M1850)
Improvement in Ambulation/Locomotion (M1860)
The magnitude of possible change for these OASIS items varies based
on the number of response options. For example, M1800 (grooming) has
four behaviorally-benchmarked response options (0 = most independent; 3
= least independent) while M1830 (bathing) has seven behaviorally-
benchmarked response options (0 = most independent; 6 = least
independent). The maximum possible change for a patient on item M1800
is 3, while the maximum possible change for a patient on item M1830 is
6. We indicated that both proposed composite measures would be computed
and normalized at the episode level, then aggregated to the HHA level
using the following steps:
Step 1: Calculate absolute change score for each OASIS
item (based on
[[Page 56530]]
change between Start of Care (SOC)/Resumption of Care (ROC) and
discharge) used to compute the Total Normalized Composite Change in
Self-Care (6 items) or Total Normalized Composite Change in Mobility (3
items) measures.
Step 2: Normalize scores based on maximum change possible
for each OASIS item (which varies across different items). The
normalized scores result in a maximum possible change for any single
item equal to ``1''; this score is provided when a patient achieves the
maximum possible change for the OASIS item.
Step 3: Total score for Total Normalized Composite Change
in Self-Care or Total Normalized Composite Change in Mobility is
calculated by summing the normalized scores for the items in the
measure. Hence, the maximum possible range of normalized scores at the
patient level for Total Normalized Composite Change in Self-Care is -6
to +6, and for Total Normalized Composite Change in Mobility is -3 to
+3.
We created two prediction models for the proposed Total Normalized
Composite Change in Self-Care (TNC_SC) and Total Normalized Composite
Change in Mobility (TNC_MOB) measures using information from OASIS
items and patient clinical condition categories (see Table 37 for
details on the number of OASIS items and OASIS clinical categories used
in the prediction models). We computed multiple ordinary least squares
(OLS) analyses beginning with risk factors that were available from
OASIS D items and patient condition groupings. Any single OASIS D item
might have more than one risk factor because we create dichotomous risk
factors for each response option on scaled (from dependence to
independence) OASIS items. Those risk factors that were statistically
significant at p<0.0001 level were kept in the prediction model. These
two versions (CY 2014 and CY 2015) of the prediction models were done
as ``proof of concept.'' We proposed that the actual prediction models
for the composite measures, if finalized, would use episodes of care
that ended in CY 2017, which we proposed would be the baseline year for
the quality outcome measures used to compute the two proposed composite
measures, as listed previously. The baseline year for these two
composite measures would be CY 2017.
The following table (Table 37) provides an overview of results from
the CY 2014 and CY 2015 prediction models for each proposed measure
with estimated R-squared values comparing observed vs. predicted
episode-level performance. This same information was included in Table
50 of the CY 2019 HH PPS proposed rule (83 FR 32428 through 32429).
[GRAPHIC] [TIFF OMITTED] TR13NO18.063
Table 37 presents the following summary information for the
prediction models for the two proposed composite measures.
Prediction Model for: This column identifies the measure
and year of data used for the two ``proof of concept'' prediction
models created for each of the two proposed composite measures, Total
Normalized Composite Change in Self-Care (TNC_SC) and Total Normalized
Composite Change in Mobility (TNC_MOB). The development of the
prediction models was identical in terms of the list of potential risk
factors and clinical categories. The only difference was one set of
prediction models used episodes of care that ended in CY 2014, while
the other set of prediction models used episodes of care that ended in
CY 2015.
Number of OASIS Items Used: This column indicates the
number of OASIS items used as risk factors in the prediction model. For
each prediction model, the number of OASIS items used is based on the
number of risk factors that were statistically significant at p<0.0001
level in the prediction model.
Number of Clinical Categories: This column indicates the
number of patient clinical categories (for example, diagnoses related
to infections or neoplasms or endocrine disorders) that are used as
risk factors in the prediction model.
R-squared Value: The R-squared values are a measure of the
proportion of the variation in outcomes that is accounted for by the
prediction model. The results show that the methodology that was used
to create the prediction models produced very consistent models that
predict at least 29 percent of the variability in the proposed
composite measures.
The prediction models are applied at the episode level to create a
specific predicted value for the composite measure for each episode of
care. These episode level predicted values are averaged to compute a
national predicted value and an HHA predicted value. The episode level
observed values are averaged to compute the HHA observed value. The HHA
TNC_SC and TNC_MOB observed scores are risk adjusted based on the
following formula:
HHA Risk Adjusted = HHA Observed + National Predicted - HHA Predicted
We explained in the proposed rule that HHAs are not allowed to skip
any of the OASIS items that are used to compute these proposed
composite measures or the risk factors that comprise the prediction
models for the two proposed composite measures. The OASIS items
typically do not include ``not available (NA)'' or ``unknown (UK)''
response options, and per HHQRP requirements,\41\ HHAs must provide
responses to all OASIS items for
[[Page 56531]]
the OASIS assessment to be accepted into the CMS data repository.
Therefore, while we believed the likelihood that a value for one of
these items would be missing is extremely small, we proposed to impute
a value of ``0'' if a value is ``missing.'' Specifically, if for some
reason the information on one or more OASIS items that are used to
compute TNC_SC or TNC_MOB is missing, we impute the value of ``0'' (no
change) for the missing value. Similarly, if for some reason the
information on one or more OASIS items that are used as a risk factor
is missing, we impute the value of ``0'' (no effect) for missing values
that comprise the prediction models for the two proposed composite
measures. We presented summary information for these two proposed
composite measures in Table 51 of the proposed rule (83 FR 32429
through 32431). We explained that because the proposed TNC_SC and
TNC_MOB are composite measures rather than simple outcome measures, the
terms ``Numerator'' and ``Denominator'' do not apply to how these
measures are calculated. Therefore, for these proposed composite
measures, the ``Numerator'' and ``Denominator'' columns in Table 51 of
the proposed rule were replaced with columns describing ``Measure
Computation'' and ``Risk Adjustment.''
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\41\ Data Specifications--https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/OASIS/DataSpecifications.html.
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We invited public comment on our proposals to replace three OASIS-
based measures, Improvement in Ambulation-Locomotion, Improvement in
Bed Transferring, and Improvement in Bathing, with two proposed
composite measures, Total Normalized Composite Change in Self-Care and
Total Normalized Composite Change in Mobility, for PY4 and subsequent
performance years.
Comment: Many commenters supported replacing the three OASIS-based
measures, Improvement in Ambulation-Locomotion, Improvement in Bed
Transferring, and Improvement in Bathing, with the two composite
measures, Total Normalized Composite Change in Self-Care and Total
Normalized Composite Change in Mobility. Some commenters, including
MedPAC, expressed concerns with the composite measures, stating that
such measures represent reporting elements completely within the
control of HHAs and may incentivize them to change their coding
practices in order to improve performance on such measures (and thus,
positively affect risk-adjustment or payment adjustments in their
favor). Another commenter questioned the methodology for the maximum
possible change calculation, as each patient's maximum score for a
specific question would be based upon the total number of responses
possible for that OASIS question. The commenter was concerned that this
methodology does not create an equal ability for HHAs to improve
outcomes for certain populations of patients, such as those who benefit
from home health physical therapy but have limited ability to improve
upon scores on certain OASIS items such as transferring due to chronic
musculoskeletal or neurological conditions. This same commenter
questioned the use of a CY 2017 baseline year for these new composite
measures, rather than the CY 2015 baseline year used for the other
measures in the measure set, which it believed added complexity to the
model. Another commenter expressed concern about the proposed Total
Normalized Composite Change in Self Care measure, citing that the
proposed composite measure uses outcome measures that are not currently
included in the HHVBP Model and have not been a priority focus for
quality improvement for agencies participating in the HHVBP Model.
Response: With regard to the concerns raised by MedPAC and others
regarding the data elements that comprise the composite measures, we
note that we are also finalizing our proposal (as discussed elsewhere
in this final rule with comment period) to reduce the weight of the
OASIS-based measures relative to the other measure areas (claims-based
and HHCAHPS). Although we continue to believe that the OASIS-based
measures yield reliable information for assessing HHAs' quality
performance and capture important information about beneficiaries'
function and improvement, our weighting methodology will increase the
collective weight of the claims-based and HHCAHPS measures, which
utilize data from claims and patient surveys and not self-reported
data, relative to the OASIS-based measures. Regarding the commenter's
concerns with the composite measure methodology, as discussed
previously, our methodology uses normalized scores that take into
account the difference in measure response scales, and result in a
maximum possible change for any single OASIS item that is equal to
``1'' regardless of the possible range of response options for that
particular OASIS item. This methodology accounts for changes to the
scores on individual OASIS items while also taking into account that
not all patients are able to significantly improve on all aspects of
each composite measure. In the case of patients with certain chronic
conditions where there is limited ability to improve on some areas of
mobility, as the commenter noted, such beneficiaries may still benefit
from home health care services such as physical therapy. We believe
that including the composite measure (versus including one or more
individual OASIS items related to transfers, which would place more
weight on those individual items) will encourage HHAs to focus on
improving overall mobility without penalizing HHAs that are unable to
improve on OASIS scores for certain patients on a particular item.
Regarding the comment that CMS is adding complexity to the model by
using CY 2017 as the baseline year for the composite measures rather
than the CY 2015 baseline year used for the remainder of the measures
in the measure set, we note that, as we indicated in the CY 2016 HH PPS
final rule, for the starter set of quality measures used in the model,
2015 would consistently be used as the baseline period in order to
evaluate the degree of change that may occur over the multiple years of
the model (80 FR 68681). These new composite measures were not part of
the model's starter set. We believe that using more currently available
calendar year data to assess HHA performance on these new composite
measures will result in a more accurate performance score.
Finally, while not all of the OASIS items that comprise the Total
Normalized Composite Change in Self Care composite measure are
currently included in the measure set for the HHVBP Model, the
composite measure would use data on these OASIS items that are already
collected from the participating HHAs. All HHAs must report such data
in order to meet the requirements for certification as an HHA, per the
Medicare Conditions of Participation (CoP) requirements at Sec.
484.55(c)(2). The individual OASIS items included in the Self-Care and
Mobility composite measures focus on areas that target broad clinical
goals related to therapy provided in the home setting: Improvement in
ability to conduct activities of daily living for oneself (that is,
dressing and bathing) and improvement in mobility (that is, ability to
transfer). While not all of the individual OASIS items that comprise
the composite measures are currently included in the HHVBP Model
measure set, they reflect activities and goals that are consistent with
the goals of the HHVBP Model: To encourage HHAs to improve the quality
of care for beneficiaries. We expect that HHAs already focus on
improvement in such areas not just because such items are included in
the OASIS or are required
[[Page 56532]]
to be reported in order to become a Medicare-certified HHA, but also
because self-care and mobility are areas of great importance to
patients and families and improvement in such areas may allow
beneficiaries to remain in the home setting (versus an institution) and
contribute to beneficiaries' quality of life. Furthermore, we note that
the Conditions of Participation require OASIS accuracy and that
monitoring and reviewing is done by CMS surveyors. CMS also conducts
activities to validate the same self-reported OASIS data that is used
for payment.
Comment: Many commenters suggested that stabilization measures
should be recognized in HHVBP as opposed to just focusing on
improvement measures, given that stabilization is sometimes a more
realistic goal than improvement for certain patients.
Response: We previously discussed our analyses of existing measures
relating to stabilization in the CY 2016 HH PPS final rule.
Specifically, we stated that while we considered using some of the
stabilization measures for this model, we found that in contrast to the
average HHA improvement measure scores which ranged from 56 to 65
percent, the average HHA stabilization measure scores ranged from 94 to
96 percent. Using measures where the average rates are nearly 100
percent would not allow for meaningful comparisons between competing
HHAs on the quality of care delivered (80 FR 68669 through 68670).
While the commenters did not suggest specific stabilization measures
for our consideration, we note that in the years since the CY 2016 HH
PPS final rule was published, we have continued to explore whether the
inclusion of stabilization measures may be appropriate for the HHVBP
Model, however we have not identified any such measures that we believe
would allow for meaningful comparison of HHA performance. Although we
appreciate commenters' concerns that some beneficiaries may have
limited opportunity to improve and that stabilization may be a more
realistic goal for such patients, based on these analyses, we do not
believe these measures are appropriate for inclusion in the Model at
this time.
Final Decision: After consideration of the public comments we
received and for the reasons we discussed previously, we are finalizing
our proposal to replace three OASIS-based measures, Improvement in
Ambulation-Locomotion, Improvement in Bed Transferring, and Improvement
in Bathing, with two composite measures, Total Normalized Composite
Change in Self-Care and Total Normalized Composite Change in Mobility,
for PY4 and subsequent performance years.
Table 38 reflects our finalized polices to remove the Influenza
Immunization Received for Current Flu Season and Pneumococcal
Polysaccharide Vaccine Ever Received measures and to replace the
Improvement in Ambulation-Locomotion, Improvement in Bed Transferring,
and Improvement in Bathing measures with the new Total Normalized
Composite Change in Self-Care and Total Normalized Composite Change in
Mobility measures. Table 38 identifies the applicable measures set for
PY4 and each subsequent performance year until such time that another
set of applicable measures, or changes to this measure set, are
proposed and finalized in future rulemaking.
BILLING CODE 4120-01-P
[[Page 56533]]
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[GRAPHIC] [TIFF OMITTED] TR13NO18.065
[[Page 56535]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.066
[[Page 56536]]
3. Reweighting the OASIS-Based, Claims-Based, and HHCAHPS Measures
In the CY 2016 HH PPS final rule, we finalized weighting measures
within each of the HHVBP Model's four classifications (Clinical Quality
of Care, Care Coordination and Efficiency, Person and Caregiver-
Centered Experience, and New Measures) the same for the purposes of
payment adjustment. We finalized weighting each individual measure
equally because we did not want any one measure within a classification
to be more important than another measure, to encourage HHAs to
approach quality improvement initiatives more broadly, and to address
concerns where HHAs may be providing services to beneficiaries with
different needs. Under this approach, a measure's weight remains the
same even if some of the measures within a classification group have no
available data. We stated that in subsequent years of the Model, we
would monitor the impact of equally weighting the individual measures
and may consider changes to the weighting methodology after analysis
and in rulemaking (80 FR 68679).
For PY4 and subsequent performance years, we proposed to revise how
we weight the individual measures and amend Sec. 484.320(c)
accordingly (83 FR 32431). Specifically, we proposed to change our
methodology for calculating the Total Performance Score (TPS) by
weighting the measure categories so that the OASIS-based measure
category and the claims-based measure category would each count for 35
percent and the HHCAHPS measure category would count for 30 percent of
the 90 percent of the TPS that is based on performance of the Clinical
Quality of Care, Care Coordination and Efficiency, and Person and
Caregiver-Centered Experience measures. We noted that these measures
and their proposed revised weights would continue to account for the 90
percent of the TPS that is based on the Clinical Quality of Care, Care
Coordination and Efficiency, and Person and Caregiver-Centered
Experience measures. Data reporting for each New Measure would continue
to have equal weight and account for the 10 percent of the TPS that is
based on the New Measures collected as part of the Model. As discussed
further in the proposed rule and in this final rule with comment
period, we stated that we believe that this proposed reweighting, to
allow more weight for the claims-based measures, would better support
improvement in those measures.
We explained in the proposed rule that weights would also be
adjusted under our proposal for HHAs that are missing entire measure
categories. For example, if an HHA is missing all HHCAHPS measures, the
OASIS and claims-based measure categories would both have the same
weight (50 percent each). We stated that we believe that this approach
would also increase the weight given to the claims-based measures, and
as a result give HHAs more incentive to focus on improving them.
Additionally, if measures within a category are missing, the weights of
the remaining measures within that measure category would be adjusted
proportionally, while the weight of the category as a whole would
remain consistent. We also proposed that the weight of the Acute Care
Hospitalization: Unplanned Hospitalization during first 60 days of Home
Health claims-based measure would be increased so that it has three
times the weight of the Emergency Department Use without
Hospitalization claims-based measure, based on our understanding that
HHAs may have more control over the Acute Care Hospitalization:
Unplanned Hospitalization during first 60 days of Home Health claims-
based measure. In addition, because inpatient hospitalizations
generally cost more than ED visits, we stated that we believe
improvement in the Acute Care Hospitalization: Unplanned
Hospitalization during first 60 days of Home Health claims-based
measure may have a greater impact on Medicare expenditures.
We proposed to reweight the measures based on our ongoing
monitoring and analysis of claims and OASIS-based measures, which shows
that there has been a steady improvement in OASIS-based measures, while
improvement in claims-based measures has been relatively flat. For
example, Figures 1 and 2 (which were included as Figures 5 and 6 in the
proposed rule) show the change in average performance for the claims-
based and OASIS-based performance measures used in the Model. For both
figures, we report the trends observed in Model and non-Model states.
In both Model and non-Model states, there has been a slight increase
(indicating worse performance) in the Acute Care Hospitalization:
Unplanned Hospitalization during first 60 days of Home Health measure.
For all OASIS-based measures, except the Improvement in Management of
Oral Medications measure and the Discharge to Community measure, there
has been substantial improvement in both Model and non-Model states.
Given these results, we stated that we believe that increasing the
weight given to the claims-based measures, and the Acute Care
Hospitalization: Unplanned Hospitalization during first 60 days of Home
Health measure in particular, may give HHAs greater incentive to focus
on quality improvement in the claims-based measures. Increasing the
weight of the claims-based measures was also supported by our
contractor's TEP.
[[Page 56537]]
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[[Page 56538]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.068
Table 52 of the proposed rule (83 FR 32434) showed the current
weighting and the proposed revised weighting for each measure based on
our proposal to change the weighting methodology from weighting each
individual measure equally to weighting the OASIS, claims-based, and
HHCAHPS measure categories at 35-percent, 35-percent and 30-percent,
respectively. Table 52 of the proposed rule also showed the proposed
weighting methodology based on various scoring scenarios. This same
information is presented in Table 39 of this final rule with comment
period. For example, for HHAs that are exempt from their beneficiaries
completing HHCAHPS surveys, the total weight given to OASIS-based
measures scores would be 50 percent, with all OASIS-based measures
(other than the two composite measures) accounting for an equal
proportion of that 50 percent, and the total weight given to the
claims-based measures scores would be 50 percent, with the Acute Care
Hospitalization: Unplanned Hospitalizations measure accounting for
37.50 percent and the ED Use without Hospitalization measure accounting
for 12.50 percent. The OASIS- and claims-based measure categories would
have equal weights in this scenario because the weight for each
remaining category when one category is missing is based on the
relative weight of the category when all three are present. Because
both the OASIS- and claims-based categories would have a weight of 35%
when HHCAHPS data is reported, each would have a 50% weight if HHCAHPS
data is not available. However, if no claims-based measure data is
available, the OASIS-based measures would have a higher weight than the
HHCAHPS category, because their weights when all three categories are
available are 35% and 30%, respectively. Finally, both Table 52 of the
proposed rule and Table 39 of this final rule with comment period show
the change in the number of HHAs, by size, that would qualify for a TPS
and payment adjustment under the current and proposed reweighting
methodologies, using CY 2016 data. We noted in the proposed rule that
Table 52 only reflects the proposed changes to the weighting
methodology, and not the other proposed changes to the HHVBP model for
CY 2019 which, if finalized, would change the proposed weights as set
forth in Table 52 (and Table 39 of this final rule with comment
period). We referred readers to Table 65 of the proposed rule (83 FR
32506) which reflected the weighting that would apply if all of our
proposed changes, including the proposed changes to the applicable
measure set, were adopted for CY 2019. We indicated that as reflected
in that table, the two proposed composite measures, if finalized, would
have weights of 7.5 percent when all three measure categories are
reported. For purposes of this final rule with comment period, we refer
readers to Table 50 of this final rule with comment period, which
reflects the weighting that will apply beginning in CY 2019 based on
all of our finalized proposals, including the finalized reweighting and
our finalized changes to the applicable measure set. As reflected in
Table 50 of this final rule with comment period, the two finalized
composite measures will have weights of 7.5 percent when all three
measure categories are reported.
[[Page 56539]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.069
BILLING CODE 4120-01-C
We invited public comments on the proposal to reweight the measures
within the Clinical Quality of Care, Care Coordination and Efficiency,
and Person
[[Page 56540]]
and Caregiver-Centered Experience classifications so that the OASIS-
based measures account for 35-percent, the claims-based measures
account for 35-percent, and the HHCAHPS account for 30-percent of the
90 percent of the TPS that is based on performance on these measures,
for PY4 and subsequent performance years. We also proposed to amend
Sec. 484.320 to reflect these proposed changes. Specifically, we
proposed to amend Sec. 484.320 to state that for performance years 4
and 5, CMS will sum all points awarded for each applicable measure
within each category of measures (OASIS-based, claims-based, and
HHCAHPS) excluding the New Measures, weighted at 35-percent for the
OASIS-based measure category, 35-percent for the claims-based measure
category, and 30-percent for the HHCAHPS measure category, to calculate
a value worth 90-percent of the Total Performance Score. We also
included a sample calculation in Table 53 of the proposed rule (83 FR
32435) to show how this proposal, in connection with the proposed
changes to the measure set, would affect scoring under the model as set
forth in prior rulemaking (80 FR 68679 through 68686) when all three
measure categories are reported.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Many commenters generally supported the reweighting of the
measure categories for the purpose of encouraging additional focus on
the claims-based measures, and also supported the proposed revised
weights. Some commenters were concerned that reweighting the Acute Care
Hospitalization: Unplanned Hospitalization during first 60 days of Home
Health claims-based measure to be three times the weight of the
Emergency Department Use without Hospitalization claims-based measure
would make one measure too impactful for the overall TPS, and that
significant weight on a single measure would encourage HHAs to focus on
that one measure at the expense of other measures. A commenter
suggested that the claims-based measure category should be reweighted
higher, such as 60 percent, because the commenter believed that claims-
based measures were less likely to be subject to data manipulation than
measures based on self-reported data. Another commenter recommended an
increase in weighting for claims-based measures when HHCAHPS data are
not available. MedPAC supported weighting claims measures more and
recommended the OASIS measures be weighted less than the HHCAHPS
measures because they believe that patient experience can be an
important way to assess quality of care.
Response: We appreciate the comments supporting reweighting in
general as well as our proposed reweighting percentages. We proposed to
weight the Acute Care Hospitalization: Unplanned Hospitalization during
first 60 days of Home Health claims-based measure three times the
weight of the Emergency Department Use without Hospitalization claims-
based measure because of our belief that HHAs have greater ability to
improve upon the Acute Care Hospitalization: Unplanned Hospitalization
during first 60 days of Home Health claims-based measure than the ED
measure, given that beneficiaries can self-refer to the ED but a
hospitalization requires more direct clinician involvement (from either
HHA staff or a community clinician with whom the HHA should be
coordinating care) for an admission. As noted in the proposed rule,
because inpatient hospitalizations generally cost more than ED visits,
we also believe quality improvement in the Acute Care Hospitalization:
Unplanned Hospitalization during first 60 days of Home Health claims-
based measure may have a greater impact on reducing Medicare
expenditures. We plan to monitor and evaluate the impact of weighting
the Acute Care Hospitalization: Unplanned Hospitalization during first
60 days of Home Health claims-based measure three times the weight of
the Emergency Department Use without Hospitalization claims-based
measure.
With regard to the commenter's suggestion to reweight the claims-
based measures to 60 percent, we are concerned that such an approach
would encourage HHAs to focus on the claims-based measures (and
particularly the Unplanned Hospitalization measure) at the expense of
other quality improvement efforts, such as patient experience and
mobility improvement, which are assessed through HHCAHPS and the OASIS
measures. We are attempting to balance encouraging HHAs to focus on
measures that may more heavily impact Medicare expenditures (such as
the claims-based measures) with ensuring that HHAs focus on quality
improvement across various focus areas, including those which are not
directly measured through the claims-based measures, such as patient
experience and mobility. As such, we do not believe we should increase
the weight for claims-based measures above what we have proposed when
HHCAHPS data are not available; rather, we believe a more gradual
approach is appropriate for increasing HHAs' focus on claims-based
measures. In addition, we continue to believe that OASIS-based measures
provide important information about quality of care and want to
continue to encourage HHAs to further improve on such measures.
Finally, with regard to MedPAC's suggestion to weight the HHCAHPS
higher than the OASIS-based measures, we agree with MedPAC that
measuring patient experience during home health episodes is important.
As discussed in this section, while we proposed to weight the HHCAHPS
category less than the other two categories, the overall change in the
weight for the HHCAHPS is not significant. As Table 50 reflects,
HHCAHPS were reduced from 31.25 percent to 30.00 percent for the
category and from 6.25 percent to 6.00 percent for each individual
HHCAHPS measure under our proposal. A greater reduction actually occurs
for the OASIS-based measures (as shown in Table 50, total weight for
OASIS measures goes from 56.25 percent to 35.00 percent for the
category and 6.25 percent to 5.00 percent for individual OASIS
measures, other than the two new composite measures). This is because
under current policy each HHCAHPS, OASIS-based, and claims-based
measure is weighted equally and because the number of measures in each
category differs. We believe the proposed reweighting balances our
interest in encouraging focus on claims-based measures as well as on
the patient experience and OASIS-based measures.
Comment: Several commenters suggested the weight of the HHCAHPS
measures category should not be reduced because they are concerned that
HHAs may focus less on improving upon HHCAHPS. Another commenter
suggested that the HHCAHPS measure category should not have a lower
weight than the OASIS measures category because the commenter believes
that a lower weight would suggest that patient experience is less
important than the other measures.
Response: We acknowledge the importance of the HHCAHPS measures and
gave them serious consideration when proposing measure category
reweighting. In considering revisions to the weights for HHCAHPS versus
the other measures, we attempted to balance placing more emphasis on
claims-based measures (which may have a greater impact on Medicare
expenditures) with continuing to encourage HHAs to focus on patient
experience. We note that while the OASIS measures category will
[[Page 56541]]
be reweighted from 56.25 percent to 35.0 percent (a reduction of 21.25
percent), the HHCAHPS measures category will be reweighted from 31.25
percent to 30 percent (a reduction of only 1.25 percent). We believe
this moderate reweighting of the HHCAHPS measures category is
appropriate because smaller HHAs are not required to submit their
HHCAHPS measure scores due to their limited episodes of care, and
therefore we believe that more weight should be allotted to measure
categories with broader HHVBP Model reporting across HHAs of all types.
However, as noted, our proposal only reduces the HHCAHPS weights very
slightly, which is consistent with our belief and the view expressed by
several commenters that patient experience is a crucial component of
quality measurement during home health episodes. Based on our
examination of performance data, we proposed to increase the weight of
the claims-based measures, while still seeking to encourage HHAs to
focus on other measure categories. CMS will also monitor and evaluate
the impact of the reweighting of the overall measure categories and
determine if additional adjustments are necessary in future years
through rulemaking.
Comment: Some commenters suggested that CMS should delay measure
category reweighting or maintain the current weighting methodology
because they believe that HHAs need more time to adapt to the HHVBP
Model, and that CMS should wait for information on behavioral impacts
from the new PDGM prior to making additional changes to HHVBP. Other
commenters suggested that making changes, such as reweighting, would
make the HHVBP Model difficult to evaluate and create an unfair
environment for HHAs.
Response: We carefully considered the impact on HHAs of our
proposed changes to reweight the measure categories, as well as the
effects on quality improvement for beneficiaries. We proposed to
reweight the measure categories to allow for more weight to the claims-
based measures to encourage further improvement on those measures, and
place increased focus on accountability for areas of significant
Medicare spending, such as hospitalizations. Because these measures
have been a part of the HHVBP model's applicable measure set from the
start of the model, we believe HHAs will have sufficient time to
appropriately adjust business practices and care methods as needed in
light of the proposed reweighting. The evaluation of the HHVBP model
will take into account changes in the model methodology and in the
corresponding HHA environment, such as changes to the Home Health
Prospective Payment System.
Comment: Some commenters believed that the proposed reweighting may
disincentivize some HHAs from serving vulnerable populations that are
at risk for hospitalizations. A commenter stated that the proposed
reweighting may incentivize further hospital stays.
Response: We believe that the reweighting will encourage HHAs to
further enhance their service structures to appropriately address the
needs of Medicare beneficiaries of all types by using quality
improvement processes that support the Model's quality measures,
including processes intended to reduce hospitalizations. We do not
believe that reweighting the measures would discourage HHAs from
serving vulnerable populations or incentivize further hospital stays.
Rather, we believe that reweighting the measures to increase the
emphasis on the claims-based ED use and unplanned hospitalization
measures would encourage HHAs to increase the coordination with other
providers and suppliers such as physicians and inpatient facilities
(hospitals and post-acute care (PAC) facilities) in order to reduce ED
visits and hospital admissions. We note that the claims-based ED and
hospitalization measures are included in the HH QRP and reflect goals
consistent with other CMS initiatives that focus on reducing avoidable
hospital admissions, such as the Hospital Readmissions Reduction
Program. We expect the proposed increase in the weight of these ED and
hospitalization measures to incentivize avoiding hospital stays, not
additional hospitalizations. We also do not expect that the reweighting
will cause HHAs to implement policies that do not serve vulnerable
populations at risk of hospitalization, but will instead encourage care
coordination between HHAs and other health care providers to avoid
hospitalizations, which may result in improved care for all
beneficiaries, including vulnerable populations. Moreover, in
determining the reweighting percentages, we proposed a weight of 30
percent for HHCAHPS in order to ensure patient experience across all
vulnerable populations is not negatively affected by the reweighting.
Finally, we note that HHAs in the HHVBP Model have opportunities to
share strategies for success under the model, including reducing
hospitalizations, through specialized technical assistance and learning
events provided through the Model.
Comment: A commenter suggested that the proposed reweighting was
arbitrary and that providers should be evaluated based on the most
important aspects of care.
Response: We disagree that the proposed reweighting was arbitrary.
The HHVBP model examines a broad array of quality measures that address
critical quality areas. The selected measures are intended to have a
high impact on care delivery and support the combined priorities of HHS
and CMS to improve health outcomes, quality, safety, efficiency, and
experience of care for patients. As discussed in response to other
comments, the claims-based ED and hospitalization measures are included
in the HH QRP and reflect goals consistent with other CMS initiatives
that focus on reducing avoidable hospital admissions, and we believe
our proposed reweighting will encourage increased focus on
accountability for areas of significant Medicare spending, such as
hospitalizations.
Final Decision: For the reasons stated and after consideration of
the comments received, we are finalizing the measure category
reweighting as proposed. Specifically, we are finalizing our proposal
to change our methodology for calculating the Total Performance Score
(TPS) by weighting the measure categories so that the OASIS-based
measure category and the claims-based measure category will each count
for 35 percent and the HHCAHPS measure category will count for 30
percent of the 90 percent of the TPS that is based on performance on
the Clinical Quality of Care, Care Coordination and Efficiency, and
Person and Caregiver-Centered Experience measures. We refer readers to
Table 50 in section X. Regulatory Impact Analysis of this final rule
with comment period, which reflects the weighting that will apply
beginning in CY 2019 based on all of our finalized proposals, including
the finalized reweighting and our finalized changes to the applicable
measure set. We are also finalizing our proposed amendments to Sec.
484.320 without change. Specifically, we are amending Sec. 484.320 to
state that for performance years 4 and 5, CMS will sum all points
awarded for each applicable measure within each category of measures
(OASIS-based, claims-based, and HHCAHPS) excluding the New Measures,
weighted at 35-percent for the OASIS-based measure category, 35-percent
for the claims-based measure category, and 30-percent for the HHCAHPS
measure category, to
[[Page 56542]]
calculate a value worth 90-percent of the Total Performance Score.
Table 40 (which is identical to Table 53 of the proposed rule) is a
sample calculation to show how this finalized policy, in connection
with the finalized changes to the measure set, will affect the scoring
under the model, as set forth in prior rulemaking (80 FR 68679 through
68686), when all three measure categories are reported.
[GRAPHIC] [TIFF OMITTED] TR13NO18.070
C. Performance Scoring Methodology
1. Rescoring the Maximum Amount of Improvement Points
In the CY 2016 HH PPS final rule, we finalized that an HHA could
earn 0 to 10 points based on how much its performance in the
performance period improved from its performance on each measure in the
Clinical Quality of Care, Care Coordination and Efficiency, and Person
and Caregiver-Centered Experience classifications during the baseline
period. We noted, in response to public comment about our scoring
methodology for improvement points, that we will monitor and evaluate
the impact of awarding an equal amount of points for both achievement
and improvement and may consider changes to the weight of the
improvement score relative to the achievement score in future years
through rulemaking (80 FR 68682).
We proposed to reduce the maximum amount of improvement points,
from 10 points to 9 points, for PY4 and subsequent performance years
for all measures except for the Total Normalized Composite Change in
Self-Care and Total Normalized Composite Change in Mobility measures,
for which we proposed the maximum improvement points would be 13.5 (83
FR 32435). The maximum score of 13.5 represents 90 percent of the
maximum 15 points that could be earned for each of the two composite
measures. The HHVBP Model focuses on having all HHAs provide high
quality care and we stated in the proposed rule that we believe that
awarding more points for achievement than for improvement beginning
with PY4 of the model would support this goal. We stated that we expect
that at this point several years into participation in the Model,
participating HHAs have had enough
[[Page 56543]]
time to make the necessary investments in quality improvement efforts
to support a higher level of care, warranting a slightly stronger focus
on achievement over improvement on measure performance. Furthermore, we
stated that we believe that reducing the maximum improvement points to
9 would encourage HHAs to focus on achieving higher performance levels,
and incentivizing in this manner would encourage HHAs to rely less on
their improvement and more on their achievement.
We also stated in the proposed rule that this proposal would be
consistent with public comments from prior rulemaking, and suggestions
provided by our contractor's TEP. As summarized in the CY 2016 HH PPS
final rule, we received comments encouraging us to focus on rewarding
the achievement of specified quality scores, and reduce the emphasis on
improvement scores after the initial 3 years of the HHVBP Model. Some
commenters suggested measuring performance primarily based on
achievement of specified quality scores with a declining emphasis over
time on improvement versus achievement (80 FR 68682).
The TEP also agreed with reducing the maximum number of improvement
points, which they believed would better encourage HHAs to pursue
improved health outcomes for beneficiaries. We noted in the proposed
rule that for the Hospital Value-Based Purchasing (HVBP) Program, CMS
finalized a scoring methodology where hospitals could earn a maximum of
9 improvement points if their improvement score falls between the
improvement threshold and the benchmark (76 FR 26515). We proposed that
HHVBP would employ a similar scoring methodology where HHAs could earn
a maximum of 9 improvement points.
We proposed that an HHA would earn 0-9 points based on how much its
performance during the performance period improved from its performance
on each measure in the Clinical Quality of Care, Care Coordination and
Efficiency, and Person and Caregiver-Centered Experience
classifications during the baseline period. We stated that a unique
improvement range for each measure would be established for each HHA
that defines the difference between the HHA's baseline period score and
the same state level benchmark for the measure used in the achievement
scoring calculation, according to the proposed improvement formula. If
an HHA's performance on the measure during the performance period was--
Equal to or higher than the benchmark score, the HHA could
receive an improvement score of 9 points, or 13.5 points for the Total
Normalized Composite Change in Self-Care and Total Normalized Composite
Change in Mobility measures (an HHA with performance equal to or higher
than the benchmark score could still receive the maximum of 10 points
for achievement (or 15 points, for the composite measures));
Greater than its baseline period score but below the
benchmark (within the improvement range), the HHA could receive an
improvement score of 0-9 based on the formula and as illustrated in the
examples (except for the Total Normalized Composite Change in Self-Care
and Total Normalized Composite Change in Mobility measures, for which
the maximum improvement score would be 13.5, as noted previously); \42\
or,
---------------------------------------------------------------------------
\42\ We note that in the proposed rule (83 FR 32436), we
inadvertently stated that the HHA could receive a maximum
improvement score of 15 for these composite measures. As explained
elsewhere in the proposed rule (83 FR 32435), we proposed that the
maximum improvement points for these composite measures would be
13.5.
---------------------------------------------------------------------------
Equal to or lower than its baseline period score on the
measure, the HHA could receive zero points for improvement.
[GRAPHIC] [TIFF OMITTED] TR13NO18.071
We also presented examples of how the proposed changes to the
performance scoring methodology would be applied in the context of the
measures in the Clinical Quality of Care, Care Coordination and
Efficiency, and Person and Caregiver Centered Experience
classifications (83 FR 32426 through 32438). We invited public comment
on the proposal to reduce the maximum amount of improvement points,
from 10 points to 9 points for PY 4 and subsequent performance years.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Many commenters supported rescoring in general and the
proposed rescoring. A commenter suggested that HHVBP should reward
agencies based on achievement only, and another commenter stated that
the proposed rescoring did not go far enough and would still penalize
high performing agencies.
Response: We appreciate the positive feedback on our proposed
methodology. We believe that removing improvement scores from the Model
could disadvantage smaller HHAs and those HHAs with limited resources.
Although we proposed to reduce the maximum improvement points, we
believe that the improvement points continue to play a necessary role
in promoting the consistent improvement of HHAs within the Model states
that are not performing equal to or above the state benchmark. We will
monitor and evaluate the impact of reducing the maximum improvement
points from 10 to 9 to determine if additional rescoring is necessary
in future years through rulemaking.
Final Decision: For the reasons stated and after consideration of
the comments received, we are finalizing the rescoring of the maximum
amount of improvement points, as proposed. Specifically, we are
finalizing the reduction of the maximum amount of improvement points,
from 10 points to 9 points, for PY4 and subsequent performance years
for all measures except for the Total Normalized Composite Change in
Self-Care and Total Normalized Composite Change in Mobility measures,
for which the maximum improvement points will be 13.5.
2. Examples of Calculating Achievement and Improvement Scores
For illustrative purposes we present the following examples of how
the changes to the performance scoring
[[Page 56544]]
methodology will be applied in the context of the measures in the
Clinical Quality of Care, Care Coordination and Efficiency, and Person
and Caregiver Centered Experience classifications. These HHA examples
are based on data from 2015 (for the baseline period) and 2016 (for the
performance year). We note that the figures and examples presented in
this final rule with comment period are the same figures and examples
set forth in the proposed rule (83 FR 32436 through 32438). Figure 3
shows the scoring for HHA `A' as an example. The benchmark calculated
for the improvement in pain measure is 97.676 for HHA A (note that the
benchmark is calculated as the mean of the top decile in the baseline
period for the state). The achievement threshold was 75.358 (this is
defined as the performance of the median or the 50th percentile among
HHAs in the baseline period for the state). HHA A's Year 1 performance
rate for the measure was 98.348, which exceeds the benchmark so the HHA
earned the maximum 10 points based on its achievement score. Its
improvement score is irrelevant in the calculation because measure
performance exceeded the benchmark.
Figure 3 also shows the scoring for HHA `B.' HHA B's performance on
this measure went from 52.168 (which was below the achievement
threshold) in the baseline period to 76.765 (which is above the
achievement threshold) in the performance period. Applying the
achievement scale, HHA B will earn 1.067 points for achievement,
calculated as follows: 9 * (76.765 - 75.358)/(97.676 - 75.358) + 0.5 =
1.067.\43\ Calculating HHA B's improvement score yields the following
result: based on HHA B's period-to-period improvement, from 52.168 in
the baseline year to 76.765 in the performance year, HHA B will earn
4.364 points, calculated as follows: 9 * (76.765 - 52.168)/(97.676 -
52.168) - 0.5 = 4.364.\44\ Because the higher of the achievement and
improvement scores is used, HHA B will receive 4.364 points for this
measure.
---------------------------------------------------------------------------
\43\ Achievement points are calculated as 9 * (HHA Performance
Year Score - Achievement Threshold)/(Benchmark - Achievement
threshold) + 0.5.
\44\ As finalized, the revised formula for calculating
improvement points is 9 * (HHA Performance Year Score-HHA Baseline
Period Score)/(HHA Benchmark-HHA Baseline Period Score) - 0.5. We
note that in the proposed rule (83 FR 32436), we inadvertently
included the achievement threshold of 75.358 in the denominator of
this equation rather than HHA B's baseline period score of 52.168,
however, the calculated figures were correct.
---------------------------------------------------------------------------
In Figure 4, HHA `C' yielded a decline in performance on the
improvement in pain measure, falling from 70.266 to 58.487. HHA C's
performance during the performance period was lower than the
achievement threshold of 75.358 and, as a result, the HHA will receive
zero points based on achievement. It will also receive zero points for
improvement, because its performance during the performance period was
lower than its performance during the baseline period.
[[Page 56545]]
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[[Page 56546]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.073
We will monitor and evaluate the impact of reducing the maximum
improvement points to 9 and will consider whether to propose more
changes to the weight of the improvement score relative to the
achievement score in future years through rulemaking.
D. Update on the Public Display of Total Performance Scores
In the CY 2016 HH PPS final rule (80 FR 68658), we stated that one
of the three goals of the HHVBP Model is to enhance the current public
reporting processes. We reiterated this goal and continued discussing
the public display of HHAs' Total Performance Scores (TPSs) in the CY
2017 HH PPS final rule (81 FR 76751 through 76752). We believe that
publicly reporting a participating HHA's TPS will encourage providers
and patients to use this information when selecting an HHA to provide
quality care. We stated in the proposed rule that we were encouraged by
the previous stakeholder comments and support for public reporting that
could assist patients, physicians, discharge planners, and other
referral sources to choose higher-performing HHAs.
In the CY 2017 HH PPS final rule, we noted that a commenter
suggested that we not consider public display until after the Model was
evaluated. Another commenter favored the public display of the TPS, but
recommended that CMS use a transparent process and involve stakeholders
in deciding what will be reported, and provide a review period with a
process for review and appeal before reporting.
As discussed in the CY 2017 HH PPS final rule, we are considering
public reporting for the HHVBP Model after allowing analysis of at
least eight quarters of performance data for the Model and the
opportunity to compare how these results align with other publicly
reported quality data (81 FR 76751). While we did not make a specific
proposal in the CY 2019 HH PPS proposed rule, we solicited further
public comment on what information, specifically from the CY 2017
Annual Total Performance Score and Payment Adjustment Reports and
subsequent annual reports, should be made publicly available. We noted
that HHAs have the opportunity to review and appeal their Annual Total
Performance Score and Payment Adjustment Reports 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
Total Performance Score and Payment Adjustment Report include 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 will consider what information, specifically from
the annual reports, we may consider proposing for public reporting in
future rulemaking.
Comment: Several commenters expressed support for publicly
reporting information from the Annual Total Performance Score and
Payment Adjustment Reports as they believe it would better inform
consumers and allow for more meaningful and objective comparisons among
HHAs. A commenter suggested that CMS consider providing an actual
percentile ranking for HHAs along with their TPS as this would provide
more information to both HHAs and the public. Another commenter
expressed interest in publicly reporting all information
[[Page 56547]]
relevant to the HHVBP Model such as the agency's performance on the
individual measures, percentile rankings, and comparison by state and
cohort. Several commenters expressed concern with publicly displaying
HHAs' TPSs citing that the methodology is still evolving and this data
would only represent a subset of home health providers participating in
the Model. Commenters also pointed out that consumers already have
access to the quality measures in the Model as the measures themselves
are already publicly reported on Home Health Compare. A commenter
recommended not publicly reporting the data until all states are
participating in the Model because it believes publicly reporting data
for one state but not the other can be confusing for consumers.
Response: We appreciate the comments on when and what to publicly
report and will work to ensure any data that are publicly reported from
the Annual Total Performance Score and Payment Adjustment Reports are
thoroughly explained and gives patients, physicians, discharge
planners, and other referral sources the knowledge they need to choose
higher-performing HHAs. We intend, if appropriate, to propose what
would be publicly reported and when in future rulemaking.
We received a number of out-of-scope comments on policy areas not
addressed by our proposals, including requests for us to expand the
HHVBP Model to a national program. We thank the commenters for their
input and would address any future changes through rulemaking.
V. Home Health Quality Reporting Program (HH QRP)
A. Background and Statutory Authority
Section 1895(b)(3)(B)(v)(II) of the (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 with
respect to a year in accordance with this clause, the Secretary is
directed to reduce the HH 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, for 2015 and each subsequent
year (except 2018), 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
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 CY 2007 HH PPS final rule (71 FR 65888
through 65891), the CY 2008 HH PPS final rule (72 FR 49861 through
49864), the CY 2009 HH PPS update notice (73 FR 65356), the CY 2010 HH
PPS final rule (74 FR 58096 through 58098), the CY 2011 HH PPS final
rule (75 FR 70400 through 70407), the CY 2012 HH PPS final rule (76 FR
68574), the CY 2013 HH PPS final rule (77 FR 67092), the CY 2014 HH PPS
final rule (78 FR 72297), the CY 2015 HH PPS final rule (79 FR 66073
through 66074), the CY 2016 HH PPS final rule (80 FR 68690 through
68695), the CY 2017 HH PPS final rule (81 FR 76752), and the CY 2018 HH
PPS final rule (82 FR 51711 through 51712).
Although we have historically used the preamble to the HH PPS
proposed and final rules each year to remind stakeholders of all
previously finalized program requirements, we have concluded that
repeating the same discussion each year is not necessary for every
requirement, especially if we have codified it in our regulations.
Accordingly, the following discussion is limited as much as possible to
a discussion of our proposals, the comments we received on those
proposals and our responses to those comments, and policies we are
finalizing for future years of the HH QRP after consideration of the
comments. We intend to use this approach in our rulemakings for the HH
QRP going forward.
B. General Considerations Used for the Selection of Quality Measures
for the HH QRP
1. Background
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).
Comment: A few commenters provided input on several topics
associated with measure adoption the HH QRP. Specifically, a commenter
expressed that the pace of removing historical OASIS items has not
matched the addition of new measures that meet IMPACT Act requirements.
The same commenter also requested that as IMPACT Act measures are
added, along with the burden of data collection, the applicability of
the measures to different settings be taken into consideration. Another
commenter recommended that measures account for patients who do not
have a goal of improvement and be tested to ensure their reliability
and validity in the home setting.
Response: We appreciate the comments. The removal of historic OASIS
items has been guided by our assessment regarding their continued need,
as well as our goal to streamline reporting requirements for HHAs and
minimize the reporting burden as much as possible. Adopting measures
that meet IMPACT Act requirements at the same pace that we remove other
OASIS items would not further our goal to reduce burden.
We interpret the comment regarding the applicability of quality
measures across the post-acute care settings to mean that we should
take into consideration the appropriateness of measures that would be
used in both institutional and home-based settings. While we believe
there can be overlap in patient populations across the four post-acute
care (PAC) providers for which we are required to adopt measures that
meet requirements under section 1899B of the Act, we recognize that
each PAC provider setting also has unique attributes, and we take these
differences into consideration during our measure development and
maintenance work.
With regard to the comment that we should consider the adoption of
measures that take into account patients who may not have goals for
improvement, we agree that not all patients may have goals associated
with improvement and we are interested in the utilization of such
measures that address this population in the HH QRP and in post-acute
care in general. Further, we agree that such measures should be tested
to ensure their reliability and validity in the home setting.
2. Accounting for Social Risk Factors in the HH QRP Program
In the CY 2018 HH PPS final rule (82 FR 51713 through 51714) we
discussed the importance of improving beneficiary outcomes including
reducing health disparities. We also discussed our commitment to
ensuring that medically complex patients, as well as those with social
risk factors, receive excellent care. We discussed how studies show
that social risk factors, such as being
[[Page 56548]]
near or below the poverty level as determined by HHS, belonging to a
racial or ethnic minority group, or living with a disability, can be
associated with poor health outcomes and how some of this disparity is
related to the quality of health care.\45\ Among our core objectives,
we aim to improve health outcomes, attain health equity for all
beneficiaries, and ensure that complex patients as well as those with
social risk factors receive excellent care. Within this context,
reports by the Office of the Assistant Secretary for Planning and
Evaluation (ASPE) and the National Academy of Medicine have examined
the influence of social risk factors in our value-based purchasing
programs.\46\ As we noted in the CY 2018 HH PPS final rule (82 FR 51713
through 51714), ASPE's report to Congress, which was required by the
IMPACT Act, found that, in the context of value based purchasing
programs, dual eligibility was the most powerful predictor of poor
health care outcomes among those social risk factors that they examined
and tested. ASPE is continuing to examine this issue in its second
report required by the IMPACT Act, which is due to Congress in the fall
of 2019. In addition, as we noted in the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38428 through 38429), the National Quality Forum (NQF)
undertook a 2-year trial period in which certain new measures and
measures undergoing maintenance review have been assessed to determine
if risk adjustment for social risk factors is appropriate for these
measures. The trial period ended in April 2017 and a final report is
available at: http://www.qualityforum.org/SES_Trial_Period.aspx. The
trial concluded that ``measures with a conceptual basis for adjustment
generally did not demonstrate an empirical relationship'' between
social risk factors and the outcomes measured. This discrepancy may be
explained in part by the methods used for adjustment and the limited
availability of robust data on social risk factors. NQF has extended
the socioeconomic status (SES) trial,\47\ allowing further examination
of social risk factors in outcome measures.
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\45\ See United States Department of Health and Human Services.
``Healthy People 2020: Disparities. 2014.'' Available at: http://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities; or National Academies of Sciences, Engineering, and
Medicine. Accounting for Social Risk Factors in Medicare Payment:
Identifying Social Risk Factors. Washington, DC: National Academies
of Sciences, Engineering, and Medicine 2016.
\46\ Department of Health and Human Services Office of the
Assistant Secretary for Planning and Evaluation (ASPE), ``Report to
Congress: Social Risk Factors and Performance under Medicare's
Value-Based Purchasing Programs.'' December 2016. Available at:
https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
\47\ Available at: http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=86357.
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In the CY 2018/FY 2018 proposed rules for our quality reporting and
value-based purchasing programs, we solicited feedback on which social
risk factors provide the most valuable information to stakeholders and
the methodology for illuminating differences in outcomes rates among
patient groups within a provider that will also allow for a comparison
of those differences, or disparities, across providers.
Feedback we received across our quality reporting programs included
encouraging CMS to explore whether factors could be used to stratify or
risk adjust the measures (beyond dual eligibility), to consider the
full range of differences in patient backgrounds that might affect
outcomes, to explore risk adjustment approaches, and to offer careful
consideration of what type of information display will be most useful
to the public.
We also sought public comment on confidential reporting and future
public reporting of some of our measures stratified by patient dual
eligibility. In general, commenters noted that stratified measures
could serve as tools for hospitals to identify gaps in outcomes for
different groups of patients, improve the quality of health care for
all patients, and empower consumers to make informed decisions about
health care. Commenters encouraged us to stratify measures by other
social risk factors such as age, income, and educational attainment.
With regard to value-based purchasing programs, commenters also
cautioned CMS to balance fair and equitable payment while avoiding
payment penalties that mask health disparities or discouraging the
provision of care to more medically complex patients. Commenters also
noted that value-based payment program measure selection, domain
weighting, performance scoring, and payment methodology must account
for social risk.
As a next step, we are considering options to improve health
disparities among patient groups within and across hospitals by
increasing the transparency of disparities as shown by quality
measures. We also are considering how this work applies to other CMS
quality programs in the future. We refer readers to the FY 2018 IPPS/
LTCH PPS final rule (82 FR 38403 through 38409) for more details, where
we discuss the potential stratification of certain Hospital IQR Program
outcome measures. Furthermore, we continue to consider options to
address equity and disparities in our value-based purchasing programs.
We plan to continue working with ASPE, the public, and other key
stakeholders on this important issue to identify policy solutions that
achieve the goals of attaining health equity for all beneficiaries and
minimizing unintended consequences.
Comment: Several comments supported continued investigation of ways
that social risk factors can be applied to quality measures. These
commenters also provided recommendations for possible social risk
factors, including family caregiver presence and degree of involvement,
the Area Deprivation Index, patient preference, needs of specialty
populations and disproportionate percentage of Medicaid patients. A
commenter recommended collaboration with Accountable Health Communities
to measure and eventually mitigate issues for those with advanced
illness. Another commenter noted that there are statistical methods
that can adjust for socioeconomic status (SES) factors that are
independent of quality of care and will not adjust away actual quality
disparities. The commenter also suggested that we explore the influence
of neighborhood factors that could be available from other data sources
and linked to a patient using address information. MedPAC noted that
CMS should account for social risk factors in quality programs by
adjusting payment through peer grouping and targeting technical
assistance to low-performing providers. A few commenters expressed
support for rewarding better outcomes for beneficiaries with social
risk factors. Commenters also expressed support for the reporting of
stratified outcomes measures to providers.
Response: We thank the commenters for their comments and will take
them into account as we further consider how to appropriately account
for social risk factors in the HH QRP. We also refer the reader to the
CY 2018 HH PPS final rule (82 FR 51713 through 51714), where we
discussed many of the issues raised by these commenters.
C. Removal Factors for Previously Adopted HH QRP Measures
As a part of our Meaningful Measures Initiative, discussed in
section I.D.1 of this final rule with comment period and in the CY 2019
HH PPS proposed rule (83 FR 32440 through 32441), we strive to put
patients first, ensuring that they,
[[Page 56549]]
along with their clinicians, are empowered to make decisions about
their own healthcare using data-driven information that is increasingly
aligned with a parsimonious set of meaningful quality measures. We
stated that we began reviewing the HH QRP measure set in accordance
with the Meaningful Measures Initiative discussed in section I.D.1 of
this final rule with comment period and in the CY 2019 HH PPS proposed
rule (83 FR 32440 through 32441), and that we are working to identify
how to move the HH QRP forward in the least burdensome manner possible,
while continuing to prioritize and incentivize improvement in the
quality of care provided to patients.
Specifically, we stated our belief that the goals of the HH QRP and
the measures used in the program overlap with the Meaningful Measures
Initiative priorities, including making care safer, strengthening
person and family engagement, promoting coordination of care, promoting
effective prevention and treatment, and making care affordable.
We also stated that we had evaluated the appropriateness and
completeness of the HH QRP's current measure removal factors. In the CY
2017 HH PPS final rule (81 FR 76754 through 76755), we noted that we
had adopted a process for retaining, removing, and replacing previously
adopted HH QRP measures. To be consistent with other established
quality reporting programs, in the CY 2019 HH PPS proposed rule (83 FR
32440 through 32441), we proposed to replace the six criteria used when
considering a quality measure for removal, finalized in the CY 2017 HH
PPS final rule (81 FR 76754 through 76755), with the following seven
measure removal factors, finalized for the LTCH QRP in the FY 2013
IPPS/LTCH PPS final rule (77 FR 53614 through 53615), for the SNF QRP
in the FY 2016 SNF PPS final rule (80 FR 46431 through 46432), and for
the IRF QRP in the CY 2013 OPPS/ASC final rule (77 FR 68502 through
68503), for use in the HH QRP:
Factor 1. Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made.
Factor 2. Performance or improvement on a measure does not
result in better patient outcomes.
Factor 3. A measure does not align with current clinical
guidelines or practice.
Factor 4. A more broadly applicable measure (across
settings, populations, or conditions) for the particular topic is
available.
Factor 5. A measure that is more proximal in time to
desired patient outcomes for the particular topic is available.
Factor 6. A measure that is more strongly associated with
desired patient outcomes for the particular topic is available.
Factor 7. Collection or public reporting of a measure
leads to negative unintended consequences other than patient harm.
As we stated in the proposed rule, we believe these measure removal
factors are substantively consistent with the criteria we previously
adopted (but noted that we would be changing the terminology to call
them ``factors'') and appropriate for use in the HH QRP. However, we
stated that even if one or more of the measure removal factors applies,
we might nonetheless choose to retain the measure for certain specified
reasons. We stated that examples of such instances could include when a
particular measure addresses a gap in quality that is so significant
that removing the measure could result in poor quality, or in the event
that a given measure is statutorily required. Furthermore, we noted
that consistent with other quality reporting programs, we would apply
these factors on a case-by-case basis.
We finalized in the CY 2017 HH PPS final rule (81 FR 76755) that
removal of a HH QRP measure would take place through notice and comment
rulemaking, unless we determined that a measure is causing concern for
patient safety. Specifically, in the case of a HH QRP measure for which
there is a reason to believe that the continued collection raised
possible safety concerns, we stated that we would promptly remove the
measure and publish the justification for the removal in the Federal
Register during the next rulemaking cycle. In addition, we stated that
we would immediately notify HHAs and the public through the usual
communication channels, including listening sessions, memos, email
notification, and Web postings. We stated that if we removed a measure
from the HH QRP under these circumstances but also collected data on
that measure under different statutory authority for a different
purpose, we would notify stakeholders that we would also cease
collecting the data under that alternative statutory authority.
In the CY 2019 HH PPS proposed rule (83 FR 32440 through 32441), we
also proposed to adopt an additional factor to consider when evaluating
potential measures for removal from the HH QRP measure set:
Factor 8. The costs associated with a measure outweigh the
benefit of its continued use in the program.
As we discussed in the CY 2019 HH PPS proposed rule (83 FR 32344
through 32345, 32440 through 32441), with respect to our new Meaningful
Measures Initiative, we are engaging in efforts to ensure that the HH
QRP measure set continues to promote improved health outcomes for
beneficiaries while minimizing the overall costs associated with the
program. We stated our belief that these costs are multifaceted and
include not only the burden associated with reporting, but also the
costs associated with implementing and maintaining the program. We also
stated that we had identified several different types of costs,
including, but not limited to the following:
Provider and clinician information collection burden and
burden associated with the submitting/reporting of quality measures to
CMS.
The provider and clinician cost associated with complying
with other HH programmatic requirements.
The provider and clinician cost associated with
participating in multiple quality programs, and tracking multiple
similar or duplicative measures within or across those programs.
The cost to CMS associated with the program oversight of
the measure, including measure maintenance and public display.
The provider and clinician cost associated with compliance
with other federal and state regulations (if applicable).
For example, we stated that it may be of limited benefit to retain
or maintain a measure which our analyses show no longer meaningfully
supports program objectives (for example, informing beneficiary
choice). It may also be costly for HHAs to track confidential feedback,
preview reports, and publicly reported information on a measure where
we use the measure in more than one program. We may also have to expend
resources to maintain the specifications for the measure, including the
tools needed to collect, validate, analyze, and publicly report the
measure data.
When these costs outweigh the evidence supporting the continued use
of a measure in the HH QRP, we stated our belief that it may be
appropriate to remove the measure from the program. Although we
recognize that one of the main goals of the HH QRP is to improve
beneficiary outcomes by incentivizing health care providers to focus on
specific care issues and making public data related to those issues, we
also
[[Page 56550]]
recognize that those goals can have limited utility where, for example,
the publicly reported data is of limited use because it cannot be
easily interpreted by beneficiaries and used to influence their choice
of providers. In these cases, removing the measure from the HH QRP may
better accommodate the costs of program administration and compliance
without sacrificing improved health outcomes and beneficiary choice.
We proposed that we would remove measures based on Factor 8 on a
case-by-case basis. For example, we may decide to retain a measure that
is burdensome for HHAs to report if we conclude that the benefit to
beneficiaries is so high that it justifies the reporting burden. We
stated that our goal is to move the HH QRP program forward in the least
burdensome manner possible, while maintaining a parsimonious set of
meaningful quality measures and continuing to incentivize improvement
in the quality of care provided to patients.
We invited public comment on our proposals to replace the six
criteria used when considering a quality measure for removal with the
seven measure removal factors currently adopted in the LTCH QRP, IRF
QRP, and SNF QRP. We also invited public comment on our proposal to
adopt new measure removal Factor 8: The costs associated with a measure
outweigh the benefit of its continued use in the program.
Comment: The majority of commenters supported the proposal to
replace the current six criteria with the seven factors to create
alignment with the other PAC settings. The majority of commenters also
supported the addition of Factor 8. A few commenters strongly agreed
that quality measure reporting is important, but noted that the costs
of such reporting can at times exceed the value of the data.
Response: We thank these commenters for their support.
Comment: With respect to Factor 1, a commenter noted support but
added that automatically removing topped out measures creates a risk of
decreased adherence to those evidence-based measures. The commenter
urged CMS to consider continuing to require data reporting on topped
out measures for a certain period time to ensure that performance in
certain areas of quality, such as depression and fall risk, does not
decline. Another commenter recommended that CMS periodically reassess
any measure removed under Factor 1 to determine if there has been a
decline in performance since the time the measure was removed.
Response: We thank these commenter for their comments. We do not
automatically remove topped out measures, and wish to reiterate that a
topped out measure may be retained for specified reasons. We may retain
a particular measure with high performance rates if the measure
addresses a topic related to quality that is so significant that we do
not want to risk a decline in quality that could result if we removed
the measure, or if the measure addresses a topic that is statutorily
required. In response to the commenters' concern about a decline in
performance that could result if a measure is removed based on Factor
1, we currently monitor for gaps in the quality of care related to the
topic which a removed measure addressed, and we would consider whether
to reintroduce a measure on that topic if we discovered such a gap.
Comment: A commenter raised concerns about the rationale of
removing relatively precise measures in favor of more broadly
applicable ones, noting that broader applicability and reportability do
not necessarily equate to better measures. This commenter recommended
choosing measures on the basis of their clinical significance.
Response: We agree that replacing a narrow measure with one that is
more broadly applicable would be problematic if the more broadly
applicable measure did not correlate with high quality outcomes. We
intend to only consider measure replacement under Factor 4 if the more
broadly applicable measure is at least comparable in terms of how well
it addresses quality outcomes as the measure it is replacing.
Comment: A commenter recommended that CMS change the wording of
Factor 2 from ``Performance or improvement on a measure does not result
in better patient outcomes'' to ``Performance or improvement on a
measure is not associated with better patient outcomes'' so that the
factor does not suggest that causality.
Response: We thank the commenter for its suggestion. We believe
that there is a direct correlation between performance improvement on a
measure and better patient outcomes. We would apply Factor 2 when our
data analysis indicates that, despite performance improvement on a
measure, there is no improvement in patient outcomes.
Comment: A few commenters expressed specific support for the
adoption of the new measure removal Factor 8: The costs associated with
a measure outweigh the benefit of its continued use in the program for
the HH QRP. Other commenters noted that Factor 8 was consistent with
CMS' Patients over Paperwork initiative.
Response: We appreciate the support of the addition of this measure
removal factor for the HH QRP.
Comment: Another commenter recommended that Factor 8 be applied on
a case-by-case basis, and another commenter recommended that CMS
consider a variety of costs in Factor 8's application, including costs
to providers and clinicians participating in multiple quality programs.
Another commenter opposed the adoption of Factor 8, citing the
difficulty of measuring benefits to patients when comparing costs and
benefits.
Response: We note that there are challenges in weighing the overall
benefits for patients against the associated costs. We also recognize
that various stakeholders may have different perspectives on such
benefits and costs. In light of these challenges, we intend to evaluate
each measure on a case-by-case basis, taking into account the input
from a variety of stakeholders, including, but not limited to:
Patients, caregivers, patient and family advocates, providers, provider
associations, healthcare researchers, data vendors, and other
stakeholders with insight into the benefits and costs (financial and
otherwise) of maintaining the specific measure in the HH QRP. Because
for each measure the relative benefit to each stakeholder may vary, we
believe that the benefits to be evaluated for each measure are specific
to the measure and the original rationale for including the measure in
the program. Therefore, when evaluating whether a measure should be
removed under Factor 8, we intend to assess and take into consideration
issues including the holistic balance of the costs, benefits, data,
input from stakeholders, and our policy objectives.
Final Decision: After consideration of the public comments, we are
finalizing our proposal to replace the six criteria used when
considering a quality measure for removal with the seven measure
removal factors currently adopted in other CMS programs, including LTCH
QRP, IRF QRP, and SNF QRP. We are also finalizing our proposal to add
to the HH QRP measure removal Factor 8: The costs associated with a
measure outweigh the benefit of its continued use in the program.
D. Quality Measures Currently Adopted for the HH QRP
The HH QRP currently has 30 \48\ measures for the CY 2020 program
year, as outlined in Table 41.
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\48\ In the CY 2019 HH PPS proposed rule (83 FR 32441) we
incorrectly stated that there are 31 measures for the CY 2020
program year. The current Pressure Ulcer/Injury measure, Percent of
Residents or Patients with Pressure Ulcers That Are New or Worsened
(Short Stay) (NQF #0678), will be replaced by a modified version of
that measure, Changes in Skin Integrity Post-Acute Care: Pressure
Ulcer/Injury, effective January 1, 2019.
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[[Page 56551]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.074
E. Removal of HH QRP Measures Beginning With the CY 2021 HH QRP
To address the Meaningful Measures Initiative discussed in the CY
2019 HH PPS proposed rule in the CY 2019 HH PPS proposed rule (83 FR
32442 through 32446) we proposed to remove seven measures from the HH
QRP beginning with the CY 2021 HH QRP. We received a few general
comments on the proposed removal of these measures.
Comment: Most commenters, including MedPAC, supported CMS' proposal
to remove all seven measures.
[[Page 56552]]
Response: We thank the commenters for their support of all of our
measure removal proposals.
Comment: While supportive of the proposals to remove the seven
measures, two commenters urged CMS to consider not waiting until the CY
2021 HH QRP program year to remove them from the HH QRP. These
commenters also noted that if CMS continues to collect data through the
OASIS on process measures that have been removed from the HH QRP but
still represent best practices, HHAs can continue to monitor their
performance on those measures without being concerned about having to
report them for the HH QRP.
Response: We thank the commenters for their support of the measure
removal proposals and note that we are finalizing all of them. We are
unable to update the OASIS submission system before January 1, 2020,
which is midway through the data collection period that we use for the
HH QRP (see 81 FR 76783). As a result, with respect to the five HH QRP
measures that are calculated using OASIS data (Depression Assessment
Conducted, Diabetic Foot Care and Patient/Caregiver Education
Implemented During All Episodes of Care, Multifactor Fall Risk
Assessment Conducted For All Patients Who Can Ambulate (NQF #0537),
Pneumococcal Polysaccharide Vaccine Ever Received, and Improvement in
the Status of Surgical Wounds), HHAs will be required to continue
submitting data on those measures with respect to home health quality
episodes that begin during the first two quarters of the CY 2021
program year (that is, for home health episodes that occur during the
3rd and 4th quarters of CY 2019). With respect to the two HH QRP
measures we are removing that are calculated using claims data
(Emergency Department Use without Hospital Readmission During the First
30 Days of HH (NQF #2505) and Rehospitalization During the First 30
Days of HH (NQF #2380)), we will stop collecting claims data for the
calculation of these two measures beginning with home health quality
episodes that begin on or after July 1, 2019.
We remind HHAs that the removal of a measure from the HH QRP does
not prevent HHAs from continuing to incorporate the quality process
addressed by that measure in their own quality monitoring activities,
and we would encourage HHAs to do so.
1. Removal of the Depression Assessment Conducted Measure
In the CY 2019 HH PPS proposed rule (83 FR 32442), we proposed to
remove the Depression Assessment Conducted Measure from the HH QRP
beginning with the CY 2021 HH QRP under Factor 1: Measure performance
among HHAs is so high and unvarying that meaningful distinctions in
improvements in performance can no longer be made.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we
adopted the Depression Assessment Conducted Measure beginning with the
CY 2010 HH QRP. Depression in the elderly is associated with
disability, impaired well-being, service utilization,\49\ and
mortality.\50\ This process measure reports the percentage of HH
episodes in which patients were screened for depression (using a
standardized depression screening tool) at start of care/resumption of
care (SOC/ROC). The measure is calculated solely using the OASIS Item
M1730, Depression Screening.\51\ Item M1730 is additionally used at
SOC/ROC as a risk adjuster in the calculation of several other OASIS-
based outcome measures currently adopted for the HH QRP.\52\
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\49\ Beekman AT, Deeg DJ, Braam AW, et al.: Consequences of
major and minor depression in later life: a study of disability,
well-being and service utilization. Psychological Medicine 27:1397-
1409, 1997.
\50\ Schulz, R., Beach, S.R., Ives, D.G., Martire, L.M., Ariyo,
A. A., & Kop, W.J. (2000). Association between depression and
mortality in older adults--The Cardiovascular Health Study. Archives
of Internal Medicine, 160(12), 1761-1768.
\51\ 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-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
\52\ The OASIS-based HH QRP outcome measures that use OASIS Item
M1730 as a risk adjuster in the calculation of the measure are:
Improvement in Bathing (NQF #0174), Improvement in Bed Transferring
(NQF #0175), Improvement in Ambulation/Locomotion (NQF #0167),
Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), Improvement in Management of Oral Medications
(NQF #0176), and Improvement in Status of Surgical Wounds (NQF
#0178).
---------------------------------------------------------------------------
We stated in the CY 2019 HH PPS proposed rule that in our
evaluation of the Depression Assessment Conducted Measure, we found
that HHA performance is very high and that meaningful distinctions in
improvements in performance cannot be made. The mean and median agency
performance scores for this measure in 2017 (96.8 percent and 99.2
percent, respectively) when compared to the mean and median agency
performance scores for this measure in 2010 (88.0 percent and 96.6
percent, respectively) indicate that an overwhelming majority of
patients are screened for depression in the HH setting. Further, these
performance scores demonstrate the improvement in measure performance
since its adoption in the HH QRP. In addition, in 2017 the 75th
percentile measure score (100 percent) and the 90th percentile measure
score (100 percent) are statistically indistinguishable from each
other, meaning that the measure scores do not meaningfully distinguish
scores between HHAs. Further, the Truncated Coefficient of Variation
(TCV) \53\ for this measure is 0.03, suggesting that it is not useful
to draw distinctions between individual agency performance scores for
this measure.
---------------------------------------------------------------------------
\53\ The truncated coefficient of variation (TCV) is the ratio
of the standard deviation to the mean of the distribution of all
scores, excluding the 5 percent most extreme scores. A small TCV
(<=0.1) indicates that the distribution of individual scores is
clustered tightly around the mean value, suggesting that it is not
useful to draw distinctions between individual performance scores.
---------------------------------------------------------------------------
For these reasons, we proposed to remove the Depression Assessment
Conducted Measure from the HH QRP beginning with the CY 2021 HH QRP
under our Factor 1: Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made.
We stated in the proposed rule that if we finalized this proposal,
HHAs would no longer be required to submit OASIS Item M1730, Depression
Screening at SOC/ROC for the purposes of this measure beginning January
1, 2020. HHAs would, however, continue to submit data on M1730 at the
time point of SOC/ROC as a risk adjuster for several other OASIS-based
outcome measures currently adopted for the HH QRP.\54\ We also stated
that if we finalized this proposal, data for this measure would be
publicly reported on HH Compare until January 2021.
---------------------------------------------------------------------------
\54\ The OASIS-based HH QRP outcome measures that use OASIS Item
M1730 as a risk adjuster in the calculation of the measure are:
Improvement in Bathing (NQF #0174), Improvement in Bed Transferring
(NQF #0175), Improvement in Ambulation/Locomotion (NQF #0167),
Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), Improvement in Management of Oral Medications
(NQF #0176), and Improvement in Status of Surgical Wounds (NQF
#0178).
---------------------------------------------------------------------------
We invited public comment on this proposal.
Comment: A commenter expressed general support for the removal of
the Depression Assessment Conducted measure but encouraged CMS to
consider how else mood could be assessed in the HH setting, noting that
behavioral health is a key aspect of patient outcomes.
Response: We agree that behavioral health is a key aspect of
patient outcomes and wish to clarify that the
[[Page 56553]]
removal of this measure would not eliminate mood assessment in the HH
setting. HHAs will continue to report OASIS Item M1730, Depression
Screening at the time point of SOC/ROC as part of their reporting of
data for other OASIS-based outcome measures currently used in the HH
QRP. In addition, we continue to develop and test standardized patient
assessment data elements that, if adopted, would assess the cognitive
function and mental status of patients in PAC settings.\55\
---------------------------------------------------------------------------
\55\ Development and Maintenance of Standardized Cross Setting
Patient Assessment Data for Post-Acute Care: Summary Report of
Findings from Alpha 2 Pilot Testing. Retrieved from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Alpha-2-SPADE-Pilot-Summary-Document.pdf.
---------------------------------------------------------------------------
Final Decision: After considering public comment, we are finalizing
our proposal to remove the Depression Assessment Conducted Measure from
the HH QRP. HHAs will no longer be required to submit OASIS Item M1730,
Depression Screening at SOC/ROC for the purposes of this measure
beginning with Home Health quality episodes of care that begin on or
after January 1, 2020. HHAs will, however, continue to submit data on
M1730 at the time point of SOC/ROC as a risk adjuster for several other
OASIS-based outcome measures currently adopted for the HH QRP. Data for
this measure will be publicly reported until such data are no longer
available for public reporting of this measure on HH Compare.
2. Removal of the Diabetic Foot Care and Patient/Caregiver Education
Implemented During All Episodes of Care Measure
In the CY 2019 HH PPS proposed rule (83 FR 32442 through 32443), we
proposed to remove the Diabetic Foot Care and Patient/Caregiver
Education Implemented during All Episodes of Care Measure from the HH
QRP beginning with the CY 2021 HH QRP under our proposed Factor 1:
Measure performance among HHAs is so high and unvarying that meaningful
distinctions in improvements in performance can no longer be made.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we
adopted the Diabetic Foot Care and Patient/Caregiver Education
Implemented during All Episodes of Care Measure beginning with the CY
2010 HH QRP. This process measure reports the percentage of HH quality
episodes in which diabetic foot care and patient/caregiver education
were included in the physician-ordered plan of care and implemented (at
the time of or at any time since the most recent SOC/ROC assessment).
The measure numerator is calculated using OASIS Item M2401 row a,
Intervention Synopsis: Diabetic foot care.\56\
---------------------------------------------------------------------------
\56\ 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-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
We stated in the CY 2019 HH PPS proposed rule (83 FR 32443) that in
our evaluation of the Diabetic Foot Care and Patient/Caregiver
Education Implemented during All Episodes of Care Measure, we found
that HHA performance is very high and that meaningful distinctions in
improvements in performance cannot be made. The mean and median agency
performance scores for this measure in 2017 (97.0 percent and 99.2
percent, respectively) when compared to the mean and median agency
performance score for this measure in 2010 (86.2 percent and 91.7
percent, respectively), indicate that an overwhelming majority of HH
episodes for patients with diabetes included education on foot care.
Further, these scores demonstrate the improvement in measure
performance since the Diabetic Foot Care and Patient/Caregiver
Education Implemented during All Episodes of Care Measure's adoption in
the HH QRP. In addition, in 2017, the 75th percentile measure score
(100 percent) and the 90th percentile score (100 percent) are
statistically indistinguishable from each other, meaning that the
measure scores do not meaningfully distinguish between HHAs. Further,
the TCV for this measure is 0.03, suggesting that it is not useful to
draw distinctions between individual agency performance scores for this
measure.
For these reasons, we proposed to remove the Diabetic Foot Care and
Patient/Caregiver Education Implemented during All Episodes of Care
Measure from the HH QRP beginning with CY 2021 HH QRP under our
proposed Factor 1: Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made.
We stated in the proposed rule that if we finalized this proposal,
HHAs would no longer be required to submit OASIS Item M2401 row a,
Intervention Synopsis: Diabetic foot care at the time point of Transfer
to an Inpatient Facility (TOC) and Discharge from Agency--Not to an
Inpatient Facility (Discharge) for the purposes of the HH QRP beginning
January 1, 2020. HHAs may enter an equal sign (=) for M2401, row a, at
the time point of TOC and Discharge on or after January 1, 2020. We
also stated that if we finalized this proposal, data for this measure
would be publicly reported on HH Compare until January 2021.
We invited public comment on this proposal.
Comment: Another commenter expressed general support for the
removal of the Diabetic Foot Care and Patient/Caregiver Education
Implemented during All Episodes of Care Measure, but encouraged CMS to
provide clear updates to providers about how they should complete items
until the next OASIS version is released.
Response: We thank the commenter for its support. We intend to
provide further guidance and training on how to properly complete the
OASIS.
Final Decision: After considering public comment, we are finalizing
our proposal to remove the Diabetic Foot Care and Patient/Caregiver
Education Implemented during All Episodes of Care Measure from the HH
QRP. HHAs will no longer be required to submit OASIS Item M2401 row a,
Intervention Synopsis: Diabetic foot care at the time point of Transfer
to an Inpatient Facility (TOC) and Discharge from Agency--Not to an
Inpatient Facility (Discharge) for the purposes of the HH QRP beginning
January 1, 2020. HHAs may enter an equal sign (=) for M2401, row a, at
the time point of TOC and Discharge on or after January 1, 2020. Data
for this measure will be publicly reported until such data are no
longer available for public reporting of this measure on HH Compare.
3. Removal of the Multifactor Fall Risk Assessment Conducted for All
Patients Who Can Ambulate (NQF #0537) Measure
In the CY 2019 HH PPS proposed rule (83 FR 32443), we proposed to
remove the Multifactor Fall Risk Assessment Conducted For All Patients
Who Can Ambulate (NQF #0537) Measure from the HH QRP beginning with the
CY 2021 HH QRP, under our proposed Factor 1: Measure performance among
HHAs is so high and unvarying that meaningful distinctions in
improvements in performance can no longer be made.
In CY 2010 HH PPS final rule (74 FR 58096 through 58098), we
adopted the Multifactor Fall Risk Assessment Conducted For All Patients
Who Can Ambulate (NQF #0537) Measure \57\
[[Page 56554]]
beginning with the CY 2010 HH QRP. This process measure reports the
percentage of HH quality episodes in which patients had a multifactor
fall risk assessment at SOC/ROC. The measure is calculated using OASIS
Item M1910, Falls Risk Assessment.\58\
---------------------------------------------------------------------------
\57\ At the time, this measure was adopted as ``Falls risk
assessment for patients 65 and older.'' The name of this measure was
updated in the CY 2018 HH PPS final rule (82 FR 51717).
\58\ 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-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
We stated in the proposed rule (83 FR 32443) that in our evaluation
of the Multifactor Fall Risk Assessment Conducted For All Patients Who
Can Ambulate (NQF #0537) Measure, we found that HHA performance is very
high and that meaningful distinctions in improvements in performance
cannot be made. The mean and median agency performance scores for this
measure in 2017 (99.3 percent and 100.0 percent, respectively) when
compared to the mean and median agency performance score for this
measure in 2010 (94.8 percent and 98.9 percent, respectively), indicate
that an overwhelming majority of patients in an HHA have had a
multifactor fall risk assessment at SOC/ROC and demonstrates the
improvement in measure performance since its adoption. In addition, in
2017, the 75th percentile measure score (100 percent) and the 90th
percentile measure score (100 percent) are statistically
indistinguishable from each other, meaning that the measure scores do
not meaningfully distinguish between HHAs. Further, the TCV for this
measure is 0.01, suggesting that it is not useful to draw distinctions
between individual agency performance scores for this measure.
For these reasons, we proposed to remove the Multifactor Fall Risk
Assessment Conducted For All Patients Who Can Ambulate (NQF #0537)
Measure from the HH QRP beginning with the CY 2021 HH QRP, under our
proposed Factor 1: Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made.
We stated in the proposed rule that if we finalized this proposal,
HHAs would no longer be required to submit OASIS Item M1910, Falls Risk
Assessment at SOC/ROC beginning January 1, 2020. HHAs may enter an
equal sign (=) for M1910 at the time point of SOC and ROC beginning
January 1, 2020. We also stated that if we finalized this proposal,
data for this measure would be publicly reported on HH Compare until
January 2021.
We invited public comment on this proposal.
Comment: Another commenter expressed general support for the
removal of the Multifactor Fall Risk Assessment Conducted For All
Patients Who Can Ambulate (NQF #0537) Measure, but encouraged CMS to
consider whether it is appropriate to adopt measures when performance
is high initially.
Response: We thank the commenter for its support. We agree that it
is important to evaluate whether the measure rates on a measure being
considered for adoption are already high because that analysis bears on
the question of whether the measure is needed to address a gap in
quality. However, we wish to note that there may be quality measures
that address an important Meaningful Measure Area in which most
providers will likely perform well. Examples of such measures include
those that take into account ``never events,'' such as falls with major
injury, or topics such as potentially preventable readmissions. In
these instances, such performance information remains useful to
consumers and providers even if the measure performance is high
initially.
Final Decision: After considering public comment, we are finalizing
our proposal to remove the Multifactor Fall Risk Assessment Conducted
For All Patients Who Can Ambulate (NQF #0537) Measure from the HH QRP.
HHAs will no longer be required to submit OASIS Item M1910, Falls Risk
Assessment at SOC/ROC beginning January 1, 2020. HHAs may enter an
equal sign (=) for M1910 at the time point of SOC and ROC beginning
January 1, 2020. Data for this measure will be publicly reported until
such data are no longer available for public reporting of this measure
on HH Compare.
4. Removal of the Pneumococcal Polysaccharide Vaccine Ever Received
Measure
In the CY 2019 HH PPS proposed rule (83 FR 32443 through 32444), we
proposed to remove the Pneumococcal Polysaccharide Vaccine (PPV) Ever
Received Measure from the HH QRP beginning with the CY 2021 HH QRP,
under our proposed Factor 3: A measure does not align with current
clinical guidelines or practice.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we
adopted the Pneumococcal Polysaccharide Vaccine Ever Received Measure
beginning with CY 2010 HH QRP. This process measure reports the
percentage of HH quality episodes during which patients were determined
to have ever received the Pneumococcal Polysaccharide Vaccine. The
measure is calculated using OASIS Items M1051, Pneumococcal Vaccine and
M1056, Reason Pneumococcal Vaccine not received.\59\
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\59\ 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-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
At the time that this measure was adopted in the HH QRP, the
Advisory Committee on Immunization Practices (ACIP),\60\ which sets
current clinical guidelines, recommended use of a single dose of the
23-valent pneumococcal polysaccharide vaccine (PPSV23) among all adults
aged 65 years and older and those adults aged 19 to 64 years with
underlying medical conditions that put them at greater risk for serious
pneumococcal infection.\61\
---------------------------------------------------------------------------
\60\ The Advisory Committee on Immunization Practices was
established under section 222 of the Public Health Service Act (42
U.S.C. 217a), as amended, to assist states and their political
subdivisions in the prevention and control of communicable diseases;
to advise the states on matters relating to the preservation and
improvement of the public's health; and to make grants to states
and, in consultation with the state health authorities, to agencies
and political subdivisions of states to assist in meeting the costs
of communicable disease control programs. (Charter of the Advisory
Committee on Immunization Practices, filed April 1, 2018 (https://www.cdc.gov/vaccines/acip/committee/ACIP-Charter-2018.pdf).
\61\ Prevention of Pneumococcal Disease: Recommendations of the
Advisory Committee on Immunization Practices (ACIP), MMWR 1997;46:1-
24.
---------------------------------------------------------------------------
Since this measure was added to the HH QRP, the ACIP has updated
its pneumococcal vaccination recommendations.\62\ Two pneumococcal
vaccines are currently licensed for use in the United States: The 13-
valent pneumococcal conjugate vaccine (PCV13) and the 23-valent
pneumococcal vaccine (PPSV23). The ACIP currently recommends that both
PCV13 and PPSV23 be given to all immunocompetent adults aged >=65
years. The recommended intervals for sequential administration of PCV13
and PPSV23 depend on several patient factors including: The current age
of the adult, whether the adult had previously received PPSV23, and the
age of the adult at the time of prior PPSV23 vaccination (if
applicable).
---------------------------------------------------------------------------
\62\ Tomczyk S, Bennett NM, Stoecker C, et al. Use of 13-valent
pneumococcal conjugate vaccine and 23-valent pneumococcal
polysaccharide vaccine among adults aged >=65 years: recommendations
of the Advisory Committee on Immunization Practices (ACIP). MMWR
2014;63: 822-5.
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[[Page 56555]]
We stated in the proposed rule that the specifications for the
Pneumococcal Polysaccharide Vaccine Ever Received Measure do not fully
reflect the current ACIP guidelines. Therefore, we believe that the
Pneumococcal Polysaccharide Vaccine Ever Received Measure no longer
aligns with the current clinical guidelines or practice. For this
reason, we proposed to remove the Pneumococcal Polysaccharide Vaccine
Ever Received Measure from the HH QRP beginning with the CY 2021 HH QRP
under our proposed Factor 3: A measure does not align with current
clinical guidelines or practice.
We stated in the proposed rule (83 FR 32444) that if we finalized
this proposal, HHAs would no longer be required to submit OASIS Items
M1051, Pneumococcal Vaccine and M1056, Reason Pneumococcal Vaccine not
received at the time point of TOC and Discharge for the purposes of the
HH QRP beginning January 1, 2020. HHAs may enter an equal sign (=) for
Items M1051 and M1056 at the time point of TOC and Discharge on or
after January 1, 2020. We also stated that if we finalized this
proposal, data for this measure would be publicly reported on HH
Compare until January 2021.
We invited public comment on this proposal.
Comment: A few commenters supported the measure removal because it
does not reflect current Advisory Committee on Immunization Practices
(ACIP) guidelines.
Response: We thank the commenters for their support.
Comment: A few commenters did not support the removal of the PPV
measure from the HH QRP, citing concerns with patient care consequences
that could occur as a result of its removal. Some of these commenters
noted that HHAs play a valuable role in providing immunizations to
home-bound patients who experience barriers to vaccination access.
Another commenter recommended retaining the current PPV measure until
it is updated to reflect the most recent ACIP guidelines for both
pneumococcal vaccinations, adding that its removal may be confusing to
HHAs and may also lead to reductions in pneumococcal immunization
rates. This commenter stated that the measure is aligned with
Meaningful Measures objectives on addressing high-impact and patient-
centered measure areas, and that retaining the measure would not be
burdensome to HHAs, given their ability to establish standing orders to
support immunization processes.
Response: While we understand that assessing and appropriately
vaccinating patients are important components of the care process, we
also prioritize ensuring that quality measures can used by
practitioners to inform their clinical decision and care planning
activities. The updated ACIP pneumococcal vaccination recommendations
require information that is often not available to HHAs, including
whether the patient has previously been vaccinated, the type of
pneumococcal vaccine received by the patient, and the sequencing of
vaccine administration. In addition, the physician who is responsible
for the home health plan of care may not be the patient's primary care
practitioner or other health care professional responsible for
providing care and services to the patient before and after discharge
from the HHA, and therefore may not be best able to provide the HHA
with such information. Also, even if the pneumococcal vaccination
status of the patient is available, OASIS Items M1051, Pneumococcal
Vaccine and M1056, Reason Pneumococcal Vaccine not received, both of
which are used in the calculation of this measure, do not correspond to
the updated ACIP pneumococcal vaccination recommendations and therefore
may not accurately measure HHA performance in this area. However, we
understand and value the role pneumococcal vaccines play in preventing
pneumococcal disease \63\ and we encourage that, whenever possible and
as appropriate, HHAs provide pneumococcal vaccinations to their
patients.
---------------------------------------------------------------------------
\63\ CDC: Pneumococcal Disease. Retrieved from: http://www.cdc.gov/pneumococcal/about/prevention.html.
---------------------------------------------------------------------------
Comment: A few commenters recommended that CMS consider using an
alternative pneumococcal measure, Pneumonia Vaccination Status for
Older Adults (NQF #0043).
Response: The specifications for the Pneumococcal Vaccination
Status for Older Adults measure also do not fully reflect the current
ACIP guidelines. Therefore, this measure would not be an appropriate
measure to consider for adoption into the HH QRP.
Final Decision: After considering public comment, we are finalizing
our proposal to remove the Pneumococcal Polysaccharide Vaccine Ever
Received Measure from the HH QRP. HHAs will no longer be required to
submit OASIS Items M1051, Pneumococcal Vaccine and M1056, Reason
Pneumococcal Vaccine not received at the time point of TOC and
Discharge for the purposes of the HH QRP beginning January 1, 2020.
HHAs may enter an equal sign (=) for Items M1051 and M1056 at the time
point of TOC and Discharge on or after January 1, 2020. Data for this
measure will be publicly reported until such data are no longer
available for public reporting of this measure on HH Compare.
5. Removal of the Improvement in the Status of Surgical Wounds Measure
In the CY 2019 HH PPS proposed rule (83 FR 32444 through 32445), we
proposed to remove the Improvement in the Status of Surgical Wounds
Measure from the HH QRP beginning with the CY 2021 HH QRP under our
proposed Factor 4: A more broadly applicable measure (across settings,
populations, or conditions) for the particular topic is available.
In the CY 2008 HH PPS final rule (72 FR 49861 through 49863), we
adopted the Improvement in the Status of Surgical Wounds Measure for
the HH QRP beginning with the CY 2008 program year. This risk-adjusted
outcome measure reports the percentage of HH episodes of care during
which the patient demonstrates an improvement in the condition of skin
integrity related to the surgical wounds. This measure is solely
calculated using OASIS Items M1340, Does this patient have a Surgical
Wound? and M1342, Status of Most Problematic Surgical Wound that is
Observable.\64\ Items M1340 and M1342 are also used at the time points
of SOC/ROC as risk adjusters in the calculation of several other OASIS-
based outcome measures currently adopted for the HH QRP.\65\
Additionally, Items M1340 and M1342 are used at the time point of
Discharge for the Potentially Avoidable Events measure Discharged to
the Community Needing Wound Care or Medication Assistance that is used
by HH surveyors during the survey process.\66\
---------------------------------------------------------------------------
\64\ Measure specifications can be found in the Home Health
Outcomes 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-C2_4-11-18.pdf).
\65\ The OASIS-based HH QRP outcome measures that use OASIS
Items M1340 and M1342 as a risk adjuster in the calculation of the
measure are: Improvement in Bathing (NQF #0174), Improvement in Bed
Transferring (NQF #0175), Improvement in Ambulation/Locomotion (NQF
#0167), Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), and Improvement in Management of Oral
Medications (NQF #0176).
\66\ Measure specifications can be found in the Home Health
Potentially Avoidable Events Measures Table on the Home Health
Quality Measures website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-PAE-Measures-Table-OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
We stated in the proposed rule (83 FR 32444) that the Improvement
in the
[[Page 56556]]
Status of Surgical Wounds Measure is limited in scope to surgical
wounds incurred by surgical patients and excludes HH episodes of care
where the patient, at SOC/ROC, did not have any surgical wounds or had
only a surgical wound that was unobservable or fully epithelialized. As
a result, the majority of HHAs are not able to report data on the
measure and the measure is limited in its ability to compare how well
HHAs address skin integrity. For example, in 2016, only 13 percent of
HH patients had a surgical wound at the beginning of their HH episode
and only 36.6 percent of HHAs were able to report data on the measure
with respect to that year.
In contrast, the Percent of Residents or Patients with Pressure
Ulcers That Are New or Worsened (Short Stay) Measure (NQF #0678) \67\
and its replacement measure, Changes in Skin Integrity Post-Acute Care:
Pressure Ulcer/Injury Measure, more broadly assess the quality of care
furnished by HHAs with respect to skin integrity. These measures
encourage clinicians to assess skin integrity in the prevention of
pressure ulcers, as well as to monitor and promote healing in all HH
patients, not just those with surgical wounds.
---------------------------------------------------------------------------
\67\ To be replaced with a modified version of that measure,
Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/Injury,
beginning with the CY 2020 HH QRP.
---------------------------------------------------------------------------
Therefore, we proposed to remove the Improvement in the Status of
Surgical Wounds Measure from the HH QRP beginning with the CY 2021 HH
QRP under our proposed Factor 4: A more broadly applicable measure
(across settings, populations, or conditions) for the particular topic
is available.
We stated in the proposed rule that if we finalized this proposal,
HHAs would no longer be required to submit OASIS Items M1340, Does this
patient have a Surgical Wound and M1342, Status of Most Problematic
Surgical Wound that is Observable, at the time points of SOC/ROC and
Discharge for the purposes of this measure beginning with January 1,
2020 episodes of care. However, HHAs would still be required to submit
data on Items M1340 and M1342 at the time point of SOC/ROC as risk
adjusters for several other OASIS-based outcome measures currently
adopted for the HH QRP,\68\ and also at the time point of Discharge for
the Potentially Avoidable Events measure Discharged to the Community
Needing Wound Care or Medication Assistance \69\ that is used by HH
surveyors during the survey process. We also stated that if we
finalized this proposal, data on this measure would be publicly
reported on HH Compare until January 2021.
---------------------------------------------------------------------------
\68\ The OASIS-based HH QRP outcome measures that use OASIS
Items M1340 and M1342 as a risk adjuster in the calculation of the
measure are: Improvement in Bathing (NQF #0174), Improvement in Bed
Transferring (NQF #0175), Improvement in Ambulation/Locomotion (NQF
#0167), Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), and Improvement in Management of Oral
Medications (NQF #0176).
\69\ Measure specifications can be found in the Home Health
Potentially Avoidable Events Measures Table on the Home Health
Quality Measures website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-PAE-Measures-Table-OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
We invited public comment on this proposal.
Comment: A commenter supported removal of the Improvement in the
Status of Surgical Wounds Measure, while encouraging CMS to monitor
other skin integrity measures to ensure that the full range of patient
skin integrity issues is captured. Another commenter opposed the
removal of this measure, but did not clarify the reason.
Response: We thank the commenters for their feedback. We will
continue to closely monitor the performance data of other skin
integrity measures.
Final Decision: After considering public comment, we are finalizing
our proposal to remove the Improvement in the Status of Surgical Wounds
Measure from the HH QRP. HHAs will no longer be required to submit
OASIS Items M1340, Does this patient have a Surgical Wound? and M1342,
Status of Most Problematic Surgical Wound that is Observable, at the
time points of SOC/ROC and Discharge for the purposes of this measure
beginning January 1, 2020. However, HHAs will still be required to
submit data on Items M1340 and M1342 at the time point of SOC/ROC as
risk adjusters for several other OASIS-based outcome measures currently
adopted for the HH QRP and also at the time point of Discharge for the
Potentially Avoidable Events measure Discharged to the Community
Needing Wound Care or Medication Assistance that is used by HH
surveyors during the survey process. Data for this measure will be
publicly reported until such data are no longer available for public
reporting of this measure on HH Compare.
6. Removal of the Emergency Department Use Without Hospital Readmission
During the First 30 Days of HH (NQF #2505) Measure
In the CY 2019 HH PPS proposed rule (83 FR 32445), we proposed to
remove the Emergency Department (ED) Use without Hospital Readmission
during the First 30 Days of HH (NQF #2505) Measure from the HH QRP
beginning with the CY 2021 HH QRP, under our proposed Factor 4: A more
broadly applicable measure (across settings, populations, or
conditions) for the particular topic is available.
In the CY 2014 HH PPS final rule (78 FR 72297 through 72301), we
adopted the claims-based ED Use without Hospital Readmission during the
first 30 days of HH (NQF #2505) Measure beginning with CY 2014 HH QRP.
The particular topic for this measure is ED utilization, as it
estimates the risk-standardized rate of ED use without acute care
hospital admission during the 30 days following the start of the HH
stay for patients with an acute inpatient hospitalization in the 5 days
before the start of their HH stay. The ED Use without Hospital
Readmission during the First 30 Days of HH (NQF #2505) Measure is
limited to Medicare FFS patients with a prior, proximal inpatient stay.
Recent analyses from 2016 and 2017 show that this measure annually
captured approximately 2.5 million (25.1 percent in 2016 and 25.1
percent in 2017) of Medicare FFS HH stays and was reportable for less
than two-thirds of the HHAs (62.1 percent in 2016 and 62.6 percent in
2017).
We stated in the proposed rule (83 FR 32444) that the ED Use
without Hospitalization During the First 60 Days of HH (NQF #0173)
Measure also addresses the topic of ED utilization during a HH stay.
This measure reports the percentage of Medicare FFS HH stays in which
patients used the ED but were not admitted to the hospital during the
60 days following the start of the HH stay. The ED Use without
Hospitalization during the First 60 days of HH (NQF #0173) Measure
includes Medicare FFS patients irrespective of whether or not they had
an acute inpatient hospitalization in the 5 days prior to the start of
the HH stay and spans the first 60 days of a HH episode. Recent
analyses using 2016 and 2017 data show this measure annually captures
approximately 8.3 million stays (81.9 percent in 2016 and 81.8 percent
in 2017) and is reportable by a greater number of HHAs (88.8 percent in
2016 and 88.1 percent in 2017) than the ED Use without Hospital
Readmission During the First 30 Days of HH (NQF #2505) Measure.
We stated in the proposed rule (83 FR 32445) that the ED Use
without Hospital Readmission During the First 30 Days of HH (NQF #2505)
Measure addresses outcomes of Medicare FFS patients for a 30-day
interval after the start of their HH care, regardless of the length of
their HH stay. The more broadly applicable ED Use without
Hospitalization during the First 60 days of HH (NQF #0173)
[[Page 56557]]
Measure addresses these same outcomes for a greater number of Medicare
FFS patients during the first 60 days of a HH stay and includes the 30-
day interval of the ED Use without Hospital Readmission During the
First 30 Days of HH (NQF #2505) Measure. The measure specifications for
both measures are otherwise harmonized along several measure
dimensions, including data source, population, denominator exclusions,
numerator, and risk adjustment methodology. As a result, removing the
ED Use without Hospital Readmission During the First 30 Days of HH (NQF
#2505) Measure in favor of the ED Use without Hospitalization during
the First 60 days of HH (NQF #0173) Measure will not result in a loss
of the ability to measure the topic of ED utilization for HH patients.
For these reasons, we proposed to remove the ED Use without
Hospital Readmission During the First 30 Days of HH (NQF #2505) Measure
from the HH QRP beginning with the CY 2021 HH QRP under our proposed
Factor 4: A more broadly applicable measure (across settings,
populations, or conditions) for the particular topic is available. We
stated in the proposed rule that if we finalized this proposal, data
for this measure would be reported on HH Compare until January 2020.
We invited public comment on this proposal.
Comment: A commenter supported the removal of this measure and
expressed appreciation that CMS identified measures for removal in
favor of more widely applicable ones.
Response: We thank the commenter for its support.
Final Decision: After considering public comment, we are finalizing
our proposal as proposed to remove the Emergency Department (ED) Use
without Hospital Readmission during the First 30 Days of HH (NQF #2505)
Measure from the HH QRP beginning with the CY 2021 HH QRP. Data for
this measure will be publicly reported until such data are no longer
available for public reporting of this measure on HH Compare.
7. Removal of the Rehospitalization During the First 30 Days of HH (NQF
#2380) Measure
In the CY 2019 HH PPS proposed rule (83 FR 32445 through 32446), we
proposed to remove the Rehospitalization during the First 30 Days of HH
(NQF #2380) Measure from the HH QRP beginning with the CY 2021 HH QRP,
under our proposed Factor 4: A more broadly applicable measure (across
settings, populations, or conditions) for the particular topic is
available.
In the CY 2014 HH PPS final rule (78 FR 72297 through 72301), we
adopted the claims-based Rehospitalization during the first 30 Days of
HH Measure beginning with the CY 2014 HH QRP. The measure was NQF-
endorsed (NQF #2380) in December 2014. The Rehospitalization during the
first 30 Days of HH (NQF #2380) Measure addresses the particular topic
of acute care hospital utilization during a HH stay. This measure
estimates the risk-standardized rate of unplanned, all-cause hospital
readmissions for patients who had an acute inpatient hospitalization in
the 5 days before the start of their HH stay and were admitted to an
acute care hospital during the 30 days following the start of the HH
stay (78 FR 72297 through 72301). The Rehospitalization During the
First 30 Days of HH (NQF #2380) Measure only includes Medicare FFS
patients. Recent analyses from 2016 and 2017 show that this measure
annually captured approximately 2.5 million (25.1 percent in 2016 and
25.1 percent in 2017) of Medicare FFS HH stays and was reportable for
less than two-thirds of the HHAs (62.1 percent in 2016 and 62.6 percent
in 2017).
In the CY 2013 HH PPS final rule (77 FR 67093 through 67094), we
finalized the claims-based Acute Care Hospitalization Measure. The
measure's title was later updated to Acute Care Hospitalization During
the First 60 Days of HH (NQF #0171) to improve clarity.\70\ The Acute
Care Hospitalization During the First 60 Days of HH (NQF #0171) Measure
also addresses the topic of acute care hospital utilization during a HH
stay. This measure reports the percentage of HH stays in which Medicare
FFS patients were admitted to an acute care hospital during the 60 days
following the start of the HH stay. The Acute Care Hospitalization
during the First 60 Days of HH (NQF #0171) Measure includes Medicare
FFS patients irrespective of whether or not they had an acute inpatient
hospitalization in the 5 days prior to the start of the HH stay and
spans the first 60 days of a HH episode. Recent analyses using 2016 and
2017 data show this measure annually captures approximately 8.3 million
stays (81.9 percent in 2016 and 81.8 percent in 2017) and is reportable
by a greater number of HHAs (88.8 percent in 2016 and 88.1 percent in
2017) than the Rehospitalization during the First 30 Days of HH (NQF
#2380) Measure.
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\70\ All-Cause Admissions and Readmissions 2015-2017 Technical
Report, National Quality Forum, Washington DC, 2017. (http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=85033) page 20.
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We stated in the proposed rule (83 FR 32446) that the
Rehospitalization during the First 30 Days of HH (NQF #2380) Measure
addresses outcomes of Medicare FFS patients for a 30-day interval after
the start of their HH care, regardless of the length of their HH stay.
In contrast, the Acute Care Hospitalization During the First 60 Days of
HH (NQF #0171) Measure is broader because it addresses these same
outcomes for a greater number of Medicare FFS patients during the first
60 Days of a HH stay, which includes the 30-day interval of the
Rehospitalization during the First 30 Days of HH (NQF #2380) Measure.
The measure specifications for both measures are otherwise harmonized
along several measure dimensions, including data source, population,
denominator exclusions, numerator, and risk adjustment methodology. As
a result, removing the Rehospitalization during the First 30 Days of HH
(NQF #2380) Measure in favor of the Acute Care Hospitalization during
the First 60 Days of HH (NQF #0171) Measure will not result in a loss
of the ability to measure the topic of acute care hospital utilization
across the HH setting.
For these reasons, we proposed to remove the Rehospitalization
during the First 30 Days of HH (NQF #2380) Measure from the HH QRP
beginning with the CY 2021 HH QRP under our proposed Factor 4: A more
broadly applicable measure (across settings, populations, or
conditions) for particular topic is available. We stated in the
proposed rule that if we finalized this proposal, data for this measure
would be publicly reported on HH Compare until January 2020.
We invited public comment on this proposal.
Comment: A commenter supported the removal of this measure and
expressed appreciation that CMS identified measures for removal in
favor of more widely applicable ones.
Response: We thank the commenter for its support.
Final Decision: After considering public comment, we are finalizing
our proposal as proposed to remove the Rehospitalization during the
First 30 Days of HH (NQF #2380) Measure from the HH QRP beginning with
the CY 2021 HH QRP. Data for this measure will be publicly reported on
HH Compare until January 2020.
F. IMPACT Act Implementation Update
In the CY 2018 HH PPS final rule (82 FR 51731), we stated that we
intended to specify two measures that will satisfy
[[Page 56558]]
the domain of accurately communicating the existence and provision of
the transfer of health information and care preferences under section
1899B(c)(1)(E) of the Act no later than January 1, 2019 and intended to
propose to adopt them for the CY 2021 HH QRP, with data collection
beginning on or about January 1, 2020.
We stated in the proposed rule that as a result of the input
provided during a public comment period between November 10, 2016 and
December 11, 2016, input provided by a technical expert panel (TEP)
convened by our contractor, and pilot measure testing conducted in
2017, we are engaging in continued development work on these two
measures, including supplementary measure testing and providing the
public with an opportunity for comment in 2018. Further, we reconvened
a TEP for these measures in April 2018. We now intend to specify the
measures under section 1899B(c)(1)(E) of the Act no later than January
1, 2020, and intend to proposed to adopt the measures beginning with
the CY 2022 HH QRP, with data collection at the time point of SOC, ROC
and Discharge beginning with January 1, 2021. For more information on
the pilot testing, we refer readers to: https://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: A commenter supported the continued development of
measures to satisfy the IMPACT Act domain of transfer of health
information and care preferences, noting its belief that these measures
will improve continuity of care and care transitions. Another commenter
did not express support or opposition, but encouraged CMS to consider
data collection burden across settings prior to adopting cross-setting
measures that satisfy the requirements of the IMPACT Act.
Response: We thank the commenters for their feedback.
G. Form, Manner, and Timing of OASIS Data Submission
Our home health regulations, codified at Sec. 484.250(a), require
HHAs to submit OASIS assessments and Home Health Care Consumer
Assessment of Healthcare Providers and Systems Survey[supreg] (HHCAHPS)
data to meet the quality reporting requirements of section
1895(b)(3)(B)(v) of the Act. In the CY 2019 HH PPS proposed rule (83 FR
32446), we proposed to revise Sec. 484.250(a) to clarify that not all
OASIS data described in Sec. 484.55(b) and (d) are needed for purposes
of complying with the requirements of the HH QRP. OASIS data items may
be submitted for other established purposes unrelated to the HH QRP,
including payment, survey, the HH VBP Model, or care planning. Any
OASIS data that are not submitted for the purposes of the HH QRP are
not used for purposes of HH QRP compliance.
We invited public comment on our proposal to revise our regulations
at Sec. 484.250(a) to clarify that not all OASIS data described in
Sec. 484.55(b) and (d) are needed for purposes of complying with the
requirements of the HH QRP.
Comment: A commenter supported all proposed changes to the HH QRP,
including updated regulations clarifying OASIS data collection
requirements. Another commenter noted that the clarification confirms
its understanding of the regulations.
Response: We thank the commenters for their support.
Final Decision: After considering public comment, we are finalizing
our proposal as proposed to revise our regulations at Sec. 484.250(a)
to clarify that not all OASIS data described in Sec. 484.55(b) and (d)
are needed for purposes of complying with the requirements of the HH
QRP.
H. Policies Regarding Public Display for the HH QRP
Section 1899B(g) of the Act requires that data and information
regarding PAC provider performance on quality measures and resource use
and other measures be made publicly available beginning not later than
2 years after the applicable specified `application date'. In the CY
2018 HH PPS final rule (82 FR 51740 through 51741), we finalized that
we will publicly display the Medicare Spending Per Beneficiary (MSPB)-
PAC HH QRP beginning in CY 2019 based on 1 year of claims data on
discharges from CY 2017.
In the CY 2019 HH PPS proposed rule (83 FR 32446), we proposed to
increase the number of years of data used to calculate the MSPB-PAC HH
QRP for purposes of display from 1 year to 2 years. Under this
proposal, data on this measure would be publicly reported in CY 2019,
or as soon thereafter as operationally feasible, based on discharges
from CY 2016 and CY 2017. We also stated that increasing the measure
calculation and public display periods from 1 to 2 years of data would
increase the number of HHAs with enough data adequate for public
reporting for the MSPB-PAC HH QRP measure from 90.7 percent (based on
August 1, 2014-July 31, 2015 Medicare FFS claims data) to 94.9 percent
(based on August 1, 2014-July 31, 2016 Medicare FFS claims data). We
further stated that increasing the measure public display periods to 2
years would align with the public display periods of these measures in
the IRF QRP, LTCH QRP, and SNF QRP.
We invited public comment on our proposal to increase the number of
years of data used to calculate the MSPB-PAC HH QRP for purposes of
display from 1 year to 2 years.
Comment: Most commenters supported changing the reporting period
for the MSPB-PAC HH QRP measure from 1 year to 2 years.
Response: We thank the commenters for their support.
Comment: Several commenters opposed changing the reporting period
for the MSPB measure from 1 to 2 years. A commenter opposed the 2-year
reporting period for the MSPB measure, noting that measurement may be
``smoothed'' and current performance diluted by relying on 2 years of
data instead of 1 year. This commenter recommended using two years of
historical data only for low-volume home health agencies that would
otherwise report insufficient data, and retaining the one-year
reporting period for larger home health agencies. Two other commenters
opposed the change to a 2-year reporting period, noting that measures
should reflect recent data and performance. Another commenter
questioned the rationale for using a 2-year measure period, noting that
while this may increase the denominator, measure accuracy might be
compromised by any changes that occurred during the measurement period.
Response: We appreciate the commenters' concern about the impact of
aggregating data across 2 years on the ability to demonstrate
improvement in a 1-year period. However, we believe that the benefit of
increasing the number of HHAs in public reporting outweighs the
expressed concern associated with increasing the measurement period to
2 years because it enables us to provide more information to consumers
who may have a limited number of HHAs in their area. Further,
improvements in performance in a measure over a 1-year period will also
be included in the 2 years of data, so providers' improvement efforts
can still be reflected in their 2-year measure scores.
We disagree with the recommendation to use 2 years of data for low-
volume HHAs but 1 year of data for larger HHAs because HHA performance
may no longer be comparable using different time periods for data
collection. Finally, there is no
[[Page 56559]]
evidence to support that increasing the number of years of data used
for the calculation of measure scores of all HHAs from 1 year to 2
years might compromise the accuracy of a measure.
Final Decision: After consideration of public comments we received,
we are finalizing our proposal as proposed to increase the number of
years of data used to calculate the MSPB-PAC HH QRP measure for
purposes of display from 1 year to 2 years.
I. Home Health Care Consumer Assessment of Healthcare Providers and
Systems[supreg] (HHCAHPS)
In the CY 2019 HH PPS proposed rule (83 FR 32446), we did not
propose changes to the Home Health Care Consumer Assessment of
Healthcare Providers and Systems[supreg] (HHCAHPS) Survey requirements
for CY 2019. Therefore, HHCAHPS Survey requirements are as codified in
Sec. 484.250 and the HHCAHPS survey vendors' data submission deadlines
are as posted on HHCAHPS website at https://homehealthcahps.org.
VI. Medicare Coverage of Home Infusion Therapy Services
In this section of the rule, we discuss the new home infusion
therapy benefit that was established in section 5012 of the 21st
Century Cures Act. This benefit covers the professional services,
including nursing services, patient training and education, and
monitoring services associated with administering infusion drugs by an
item of durable medical equipment (DME) in a patient's home. This final
rule with comment period will establish health and safety standards for
home infusion therapy and provide consistency in coverage for home
infusion therapy services. In addition, this final rule with comment
period establishes regulations for the approval and oversight of
accrediting organizations that provide accreditation to home infusion
therapy suppliers. This rule also provides information on the
implementation of the home infusion therapy services temporary
transitional payments for CYs 2019 and 2020, as mandated by section
50401 of the BBA of 2018, and finalizes a regulatory definition of
``Infusion Drug Administration Calendar Day.''
A. General Background
1. Overview
Infusion drugs and administration services can be furnished 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.
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. There is also a separate payment for drug
administration in which the payment for infusion supplies and equipment
is packaged in the payment for administration. The separate payment for
infusion drug administration in an HOPD and in a physician's office
generally includes a base payment amount for the first hour and a
payment add-on that is a different amount for each additional hour of
administration. The beneficiary is responsible for the 20 percent
coinsurance under Medicare Part B.
Medicare FFS covers outpatient infusion drugs under Part B,
``incident to'' a physician's services, 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 excluded from
Part B coverage. This determination is made on a drug-by-drug basis,
not on a beneficiary-by-beneficiary basis.\71\ The MACs update Self-
Administered Drug (SAD) exclusion lists on a quarterly basis.\72\
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\71\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
\72\ www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx?bc=AQAAAAAAAAAAAA%3D%3D.
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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. The components needed to perform home infusion include the
drug (for example, antibiotics, immune globulin), equipment (for
example, a pump), and supplies (for example, tubing and catheters).
Likewise, nursing services are 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.
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 nursing time,
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 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.
[[Page 56560]]
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 or implantable infusion pump classified as DME and
determined to be reasonable and necessary for administration of the
drug; and (2) the drug being used with the pump is itself reasonable
and necessary for the treatment of an illness or injury. Only certain
types of infusion pumps are covered under the DME benefit. The Medicare
National Coverage Determinations Manual, chapter 1, part 4, Sec. 280.1
describes the types of infusion pumps that are covered under the DME
benefit.\73\ For DME infusion pumps, Medicare Part B covers the
infusion drugs and other supplies and services necessary for the
effective use of the pump, but does not explicitly require or pay
separately for any associated home infusion nursing services beyond
what is necessary for teaching the patient and/or caregiver how to
operate the equipment in order to administer the infusion safely and
effectively.\74\ Through local coverage policies, 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.
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\73\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS014961.html.
\74\ See 42 CFR 424.57(c)(12), which states that the DME
``supplier must document that it or another qualified party has at
an appropriate time, provided beneficiaries with necessary
information and instructions on how to use Medicare-covered items
safely and effectively.''
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2. Home Infusion Therapy Legislation
Section 5012 of the 21st Century Cures Act (Pub. L. 114-255) (Cures
Act) creates a separate Medicare Part B benefit category under section
1861(s)(2)(GG) of the Act for coverage of home infusion therapy-
associated professional services for certain drugs and biologicals
administered intravenously, or subcutaneously through a pump that is an
item of DME, effective January 1, 2021. The infusion pump and supplies
(including home infusion drugs) will continue to be covered under the
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 included in the payment for
the DME), remote monitoring, and other monitoring services for the
provision of home infusion therapy furnished by a qualified home
infusion therapy supplier in the patient'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 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 home infusion therapy supplier for the items and services
(professional services, including nursing services; training and
education; remote monitoring, and other monitoring services). The
single payment must take into account, as appropriate, types of
infusion therapy, including variations in utilization of services by
therapy type. In addition, the single payment amount is required to be
adjusted to reflect geographic wage index and other costs that may vary
by region, patient acuity, and complexity of drug administration. The
single payment may be adjusted to reflect outlier situations, and other
factors as deemed appropriate by the Secretary, which are required to
be done in a budget neutral manner. Section 1834(u)(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 CPI for all urban consumers for the 12-
month period ending with June of the preceding year, reduced by the
multi-factor productivity adjustment. The unit of single payment 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, and the single
payment amount 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. Health and Safety Standards for Home Infusion Therapy
1. Introduction
Section 5012 of the Cures Act requires that, to receive payment
under the Medicare home infusion therapy benefit, home infusion therapy
suppliers must select a CMS-approved accreditation organization (AO)
and undergo an accreditation review process to demonstrate that the
home infusion therapy supplier meets the AO's standards. Section
1861(iii) of the Act,
[[Page 56561]]
as added by section 5012 of the Cures Act, sets forth four elements for
home infusion therapy in the following areas: (1) Requiring that the
patient be under the care of a physician, nurse practitioner, or
physician assistant; (2) requiring that all patients have a plan of
care established and updated by a physician that sets out the care and
prescribed infusion therapy necessary to meet the patient specific
needs; (3) providing patients with education and training on the
effective use of medications and equipment in the home (not otherwise
paid for as durable medical equipment); and (4) providing monitoring
and remote monitoring services associated with administering infusion
drugs in a patient's home.
The Journal of Infusion Nursing standards of practice specifically
address patient education, and state that it is the clinician's role to
educate the patient, caregiver, and/or surrogate about the prescribed
infusion therapy and plan of care including, but not limited to,
purpose and expected outcome(s) and/or goals of treatment, infusion
therapy administration; infusion device-related care; potential
complications; or adverse effects associated with treatment. (Infusion
Therapy Standards of Practice, 2015).\75\
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\75\ Infusion Therapy: Standards of Practice, Journal of
Infusion Nursing, Wolters Kluwer: Jan/Feb 2016 pp S25-S26.
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Currently, standards for home infusion therapy have been
established by the current AOs; however, they are not necessarily
consistent. In order to assure consistency in the areas identified in
the Act, we are establishing basic standards that all AOs will be
required to meet or exceed. We proposed universal standards for
Medicare-participating qualified home infusion therapy suppliers to
ensure the quality and safety of home infusion therapy services for all
beneficiaries that these suppliers serve.
In preparation for developing these standards and to gain a clear
understanding of the current home infusion therapy supplier private
sector climate, we reviewed the requirements established by section
5012 of the 21st Cures Act, performed an extensive review of the
standards from all six AOs that accredit home infusion suppliers (The
Joint Commission, Accreditation Commission for Health Care, Compliance
Team, Community Health Accreditation Partner, Healthcare Quality
Association on Accreditation, and National Association of Boards of
Pharmacy), and reviewed various other government and industry
publications listed in this final rule with comment period. In addition
to the standards, we reviewed the following documents related to
coverage:
Government Accountability Office-10-426 report, which
describes the state of coverage of home infusion therapy components
under Medicare fee-for-service prior to the enactment of the Cures Act
(GAO, 2010).\76\
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\76\ Government Accountability Office. (2010). Home Infusion
Therapy. Differences between Medicare and Private Insurers'
coverage. (GAO Publication No. 10-426). Washington, DC, U.S.
Government Printing Office.
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Medicare and Home Infusion white paper written by the
National Home Infusion Association (NHIA), which provided an overview
of Medicare coverage provided for Home Infusion Therapy services prior
to the enactment of the Cures Act, as well as results of a study
conducted by Avalere Health on the potential savings that could result
from Medicare coverage of infusion therapy provided in the home
(National Home Infusion Therapy Association, NDS).\77\
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\77\ National Home Infusion therapy Association. Medicare and
Home Infusion White Paper. Retrieved from https://www.nhia.org/resource/legislative/documents/NHIAWhitePaper-Web.pdf.
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American Society of Health System Pharmacists Guidelines
on Home Infusion Pharmacy Services, which provided an in-depth overview
of specialized, complex pharmaceuticals, best practices on providing
home infusion therapy in the home or alternative site settings, and the
plans to execute and manage the therapy (American Society of Health-
System Pharmacists. ASHP guidelines on Home Infusion Pharmacy Service,
2014).\78\
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\78\ American Society of Health-System Pharmacists. ASHP
guidelines on Home Infusion Pharmacy Service, 2014. Retrieved from:
https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/home-infusion-pharmacy-services.ashx?la=en&hash=255092A51D0AE4746C151C51AC7BF82217AC2F76.
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The requirements of numerous Medicare Advantage plans,
Medicare FFS, and private insurance plans.
Upon review of these materials, we believe that there is a
sufficient private-sector framework already in place to address many of
the areas that will typically be included in the establishment of basic
health and safety standards for home infusion therapy. For example,
existing AO standards include requirements related to plan of care,
monitoring, patient assessment, quality improvement, and infection
control. While the exact content of the AO standards vary, we believe
that the standards are adequate to ensure patient health and safety.
The AO representing the largest number of home infusion therapy
suppliers requires that home infusion pharmacies provide certain
services to ensure safe and appropriate therapy, in compliance with
nationally recognized standards of practice. Patient training and
education activities, as part of their required admission procedures,
include the use of medical and disposable equipment, medication
storage, emergency procedures, vascular access device management,
recognition of a drug reaction, and when to report any adverse drug
event. As such, we concluded that it was appropriate to propose
requirements for only those elements specifically identified in section
1861(iii) of the Act. Through the CMS accreditation organization
process, we would monitor home infusion therapy suppliers to assure
that services are provided in a safe and effective manner, and would
consider future rulemaking to address any areas that may need
improvement in the future. We solicited public comment on this approach
and invited comments related to the home infusion therapy standards.
2. Home Infusion Therapy Supplier Requirements (Part 486, Subpart I)
We propose to add a new 42 CFR part 486, subpart I, to incorporate
the home infusion therapy supplier requirements. The proposed
regulations would provide a framework for CMS to approve home infusion
therapy accreditation organizations and give them the authority to
approve Medicare certification for home infusion therapy suppliers.
Final subpart I would include General Provisions (Basis and Scope, and
Definitions) and Standards for Home Infusion Therapy (Plan of Care and
Required Services).
a. Basis and Scope (Sec. 486.500)
We proposed to set forth the basis and scope of part 486 at Sec.
486.500. Part 486 is based on sections 1861(iii)(2)(D) of the Act,
which establishes the requirements that a home infusion therapy
supplier must meet in order to participate in the Medicare program.
These proposed provisions serve as the basis for survey activities for
the purposes of determining whether a home infusion therapy supplier
meets the requirements for participation in Medicare. Section 1834(u)
of the Act serves as the basis for the establishment of a prospective
payment system for home infusion therapy covered under Medicare. In
addition, section 1834(u)(5) of the Act establishes the factors for the
Secretary to designate organizations to accredit suppliers furnishing
home infusion therapy and requires that organizations be designated not
later than January 1, 2021.
[[Page 56562]]
b. Definitions (Sec. 486.505)
At proposed Sec. 486.505, we define certain terms that would be
used in the home infusion therapy requirements. We define the terms
``applicable provider'', ``home'', ``home infusion drug'', and
``qualified home infusion therapy supplier'' in accordance with the
definitions set forth in section 1861(iii) of the Act. Furthermore,
section 1861(iii) of the Act includes a definition of the term ``home
infusion therapy'' that is the basis of the health and safety
requirements set forth in this final rule with comment period. In
accordance with the Act, we proposed the following definitions:
``Applicable provider'' would mean a physician, a nurse
practitioner, and a physician assistant.
``Home'' would mean a place of residence used as the home
of an individual, including an institution that is used as a home.
However, an institution that is used as a home may not be a hospital,
CAH, or SNF as defined in sections 1861(e), 1861(mm)(1), and 1819 of
the Act, respectively.
``Home infusion drug'' would mean 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.
The term does not include insulin pump systems or a self-administered
drug or biological on a self-administered drug exclusion list.
``Qualified home infusion therapy supplier'' would mean a
supplier of home infusion therapy that meets all of the following
criteria which are set forth at section 1861(iii)(3)(D)(i) of the Act:
(1) Furnishes infusion therapy to individuals with acute or chronic
conditions requiring administration of home infusion drugs; (2) ensures
the safe and effective provision and administration of home infusion
therapy on a 7-day-a-week, 24-hour-a-day basis; (3) is accredited by an
organization designated by the Secretary in accordance with section
1834(u)(5) of the Act; and (4) meets such other requirements as the
Secretary determines appropriate.
c. Standards for Home Infusion Therapy
Proposed subpart I, as required by section 5012 of the Cures Act,
would specify that the qualified home infusion therapy supplier ensure
that all patients have a plan of care established by a physician.
(1) Plan of Care (Sec. 486.520)
Proposed Sec. 486.520(a), requires that all patients must be under
the care of an ``applicable provider'' as defined at Sec. 486.505.
Proposed Sec. 486.520(b) requires that the qualified home infusion
therapy supplier ensure that all patients must have a plan of care
established by a physician that prescribes the type, amount, and
duration of home infusion therapy services that are furnished. The plan
of care would also include the specific medication, 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.
We also proposed, at Sec. 486.520(c), that the qualified home
infusion therapy supplier must ensure that the plan of care for each
patient is periodically reviewed by the physician. We did not propose
to establish a specific timeframe for review requirements, but the
expectation is that the physician is active in the patient's care and
can make appropriate decisions related to the course of therapy if
changes are necessary in regards to the progress of the patient and
goal achievement with the infusion therapy.
(2) Required Services (Sec. 486.525)
Section 1861(iii)(2)(D)(II) of the Act specifically mandates that
qualified home infusion therapy suppliers ensure the safe and effective
provision and administration of home infusion therapy on a 7-day-a-
week, 24-hour-a-day basis. Infusion drugs are administered directly
into a vein or under the skin, eliciting a more rapid clinical response
than with oral medications. Consequently, an adverse effect or a
medication error could result in a quicker and/or more severe
complication. Therefore, at Sec. 486.525(a), we proposed to require
the provision of professional services, including nursing services,
furnished in accordance with the plan of care. We proposed to require
that home infusion therapy suppliers ensure that professional services
are available on a 7-day-a-week, 24-hour-a-day basis in order to ensure
that patients have access to expert clinical knowledge and advice in
the event of an urgent or emergent infusion-related situation. This
requirement is imperative, as the success of home infusion therapy is
often dependent upon the professional services being available during
all hours and days of the week that allows for the patient to safely
and effectively manage all aspects of treatment.
At Sec. 486.525(b), we proposed to require patient training and
education, not otherwise paid for as durable medical equipment, and as
described in 42 CFR 424.57(c)(12). This requirement is consistent with
section 1861(iii)(2)(B) of the Act. In addition, the patient training
and education requirements are consistent with standards that are
already in place, as established by the current AOs of home infusion
therapy suppliers. This is a best practice, as home infusion therapy
may entail the use of equipment and supplies with which patients' may
not be comfortable or familiar.
At Sec. 486.525(c), we proposed to require qualified home infusion
therapy suppliers to provide remote monitoring and monitoring services
for the provision of home infusion therapy services and home infusion
drugs furnished by a qualified home infusion therapy supplier. This
proposed requirement is also consistent with section 1861(iii)(2)(B) of
the Act. Monitoring the patient receiving infusion therapy in their
home is an important standard of practice that is an integral part of
providing medical care to patients in their home.\79\ The expectation
is that home infusion therapy suppliers would provide ongoing patient
monitoring and continual reassessment of the patient to evaluate
response to treatment, drug complications, adverse reactions, and
patient compliance. Remote monitoring may be completed through follow-
up telephone or other electronic communication, based on patient
preference of communication. However, we do not propose to limit remote
monitoring to these methods. Suppliers would be permitted to use all
available remote monitoring methods that are safe and appropriate for
their patients and clinicians and as specified in the plan of care as
long as adequate security and privacy protections are utilized.
Monitoring may also be performed directly during in-home patient
visits. Additional discussion on remote monitoring and monitoring
services can be found in section II.C.2.d. of this final rule with
comment period.
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\79\ Infusion Therapy: Standards of Practice, Journal of
Infusion Nursing, Wolters Kluwer: Jan/Feb 2016 pp S25-S26.
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Comment: We received a few comments related to whether we should
include specific timeframes for review of the plan of care. Most
comments suggested that CMS should align the physician review of the
plan of care with State laws where they exist, while another commenter
suggested that we require the plan of care be reviewed
[[Page 56563]]
every 30 days. Most commenters also stated that they believed adding
additional reviews could conflict with the State laws and would create
undue burden on home infusion therapy suppliers.
Response: We agree with the commenters that establishing timeframe
requirements for the physician review of the patient plan of care could
create duplicative requirements and add burden to home infusion therapy
suppliers. Therefore, we are not including specific timeframes for the
review of the plan of care, and will defer to existing State laws and
regulations.
Comment: We received several comments requesting that the proposed
home infusion therapy health and safety standards include various
requirements for pharmaceutical standards, such as drug preparation and
dispensing procedures. Specifically, commenters recommended compliance
with sterile compounding standards and those requirements enforced by
the United States Pharmacopeia and Food and Drug Administration.
Response: We agree it is important that all health care providers
and suppliers, including home infusion therapy suppliers, provide
services to patients in a safe and professional manner, and in
accordance with professional standards of practice. To address these
concerns, we have amended the regulation text at Sec. 486.525 Required
services, by adding Sec. 486.525(b) which requires that all home
infusion therapy suppliers must provide home infusion therapy services
in accordance with nationally recognized standards of practice, and in
accordance with all applicable state and federal laws and regulations.
This could include the applicable provisions in the Federal Food, Drug,
and Cosmetic Act.
Comment: Several commenters suggested we expand the standard under
proposed Sec. 486.525, Required services, (a) Professional services.
Specifically the comments requested that CMS define the term
``Professional services,'' and to specify the specific services that
would be applicable. Commenters suggested that the term ``professional
services'' could be defined to include things such as clinical care
planning, care coordination, pharmacy services, and nursing services to
name a few.
Response: We agree various professional services may be necessary
in the care of beneficiaries utilizing the Medicare home infusion
therapy benefit. As stated in the proposed rule preamble, we have
mirrored the language in section 1861(iii)(2)(A) that requires the
provision of professional services, including nursing services,
furnished in accordance with the plan of care by the home infusion
therapy supplier. By specifically enumerating a specific list of
services we would risk inadvertently excluding services that may be
necessary for the care of a specific patient as part of the required
services under the home infusion therapy benefit. We acknowledge that
pharmacy services are closely related to the home infusion therapy
benefit; however, at this time pharmacy services associated with the
preparation and dispensing of home infusion therapy drugs are covered
under the Medicare Part B DME benefit and are not part of this specific
home infusion therapy benefit.
Comment: We received several comments that did not appear to
support the proposed regulation. However, the comments were non-
specific in nature, and did not provide any detailed information to
which we could provide an appropriate response.
Response: We believe the proposed home infusion therapy health and
safety standards are important and essential because they provide the
essential basis for establishing a robust accreditation program that
will protect the health and safety of Medicare beneficiaries.
Therefore, we are finalizing, with modifications, the home infusion
therapy health and safety regulations. As previously described, we
received several public comments regarding the home infusion therapy
supplier health and safety regulations proposed at Sec. 486.520, Plan
of care and Sec. 486.525, Required services. We are finalizing these
regulations, and are adding the following requirement to Sec.
486.525(b): All home infusion therapy suppliers must provide home
infusion therapy services in accordance with nationally recognized
standards of practice, and in accordance with all applicable state and
federal laws and regulations.
C. Approval and Oversight of Accrediting Organizations for Home
Infusion Therapy Suppliers
1. Background
Section 1861(iii)(3)(D)(III) of the Act, as added by section
5012(b) of the Cures Act, requires that a home infusion therapy
supplier be accredited by an AO designated by the Secretary in
accordance with section 1834(u)(5) of the Act. Section 1834(u)(5)(A) of
the Act identifies factors for designating AOs and modifying the list
of designated AOs. These statutory factors are: (1) The ability of the
organization to conduct timely reviews of accreditation applications;
(2) the ability of the organization take into account the capacities of
suppliers located in a rural area (as defined in section 1886(d)(2)(D)
of the Act); (3) whether the organization has established reasonable
fees to be charged to suppliers applying for accreditation; and, (4)
such other factors as the Secretary determines appropriate.
Section 1834(u)(5)(B) of the Act requires the Secretary to
designate AOs to accredit home infusion therapy suppliers furnishing
home infusion therapy not later than January 1, 2021. In the proposed
rule we stated that, there are six AOs that are currently providing
accreditation to home infusion therapy suppliers, which are: (1) The
Joint Commission (TJC); (2) Accreditation Commission for Health Care
(ACHC); (3) Compliance Team (TCT); (4) Community Health Accreditation
Partner (CHAP); (5) Healthcare Quality Association on Accreditation;
and (6) National Association of Boards of Pharmacy. However, since the
publication of the proposed rule, we have learned that there are two
additional organizations that provide accreditation to home infusion
therapy suppliers. These organizations are: (1) The Centers for
Pharmacy Practice Accreditation (CPPA) and (2) URAC.
Five of these AOs are providing accreditation to home infusion
therapy suppliers as part of the overall accreditation of home health
agencies. The remaining AOs are pharmacy associations that have home
infusion therapy accreditation programs that have not been approved by
Medicare.
We proposed to publish a solicitation notice in the Federal
Register, in which we would invite national AOs to submit an
application to CMS for approval of their home infusion therapy
accreditation program. We proposed that this solicitation notice would
be published after the final rule is published, so that we can
designate AOs to accredit home infusion therapy suppliers by no later
than January 1, 2021 as required by 1834(u)(5)(B) of the Act. We
further proposed that the application submitted by any AOs that respond
to the solicitation notice would be required to meet all requirements
set forth in proposed Sec. 488.1010 and demonstrate that their
substantive accreditation requirements are equal to or more stringent
than our proposed regulations at part 485, subpart I.
Section 1861(iii)(3)(D) of the Act requires ``qualified home
infusion therapy suppliers'' to be accredited by a CMS-approved AO. We
proposed that, in order for the home infusion therapy suppliers
accredited by the eight AOs that currently provide non-Medicare
[[Page 56564]]
approved home infusion therapy accreditation to continue receiving
payment for the home infusion therapy services they provide, the eight
existing home infusion therapy AOs must submit applications to CMS for
Medicare approval of their home infusion therapy accreditation
programs. We made this proposal because the accreditation currently
being provided by these AOs has not been approved by CMS as required by
section 1861(iii)(3)(D) of the Act. More specifically, five of these
existing home infusion AOs are home health agency (HHA) AOs that have
been approved by CMS to provide HHA accreditation to home health
agencies. (HHAs). These HHA AOs started offering home infusion therapy
accreditation as part of their HHA accreditation program, but none of
these HHA AOs have received separate CMS approval for their home
infusion therapy accreditation programs. The remaining 3 of the
existing home infusion AOs are pharmacy association that offer a non-
CMS approved home infusion therapy accreditation programs. As noted,
all these existing home infusion AOs would have to submit an
application to CMS for Medicare approval of their home infusion therapy
accreditation program.
We proposed that the home infusion therapy accreditation program be
a separate and distinct accreditation program from the HHA AO's home
health accreditation program. This would mean that AOs currently
surveying HHAs would have a separate accreditation program with
separate survey processes and standards for the accreditation of home
infusion therapy suppliers. In addition, we proposed to require that
the applications submitted by all HHA and pharmacy AOs that currently
provide accreditation to home infusion therapy suppliers meet the
application requirements set forth in the proposed home infusion
therapy AO approval and oversight regulations at Sec. 488.1010 and
meet or exceed the substantive home infusion therapy health and safety
standards proposed to be set out at 42 CFR part 485, subpart I.
Section 1834(u)(5)(C)(ii) of the Act states that in the case where
the Secretary removes a home infusion therapy AO from the list of
designated home infusion therapy AOs, any home infusion therapy
supplier that is accredited by the home infusion therapy AO during the
period beginning on the date on which the home infusion therapy AO is
designated as an CMS-approved home infusion therapy AO and ending on
the date on which the home infusion therapy AO is removed from such
list, shall be considered to have been accredited by an home infusion
therapy AO designated by the Secretary for the remaining period such
accreditation is in effect. Under section 1834(u)(5)(D) of the Act, in
the case of a home infusion therapy supplier that is accredited before
January 1, 2021 by a home infusion therapy AO designated by the
Secretary as of January 1, 2019, such home infusion therapy supplier
shall be considered to be accredited by a home infusion therapy AO
designated by the Secretary as of January 1, 2023, for the remaining
period such accreditation is in effect. Home infusion therapy suppliers
are required to receive accreditation before receiving Medicare payment
for services provided to Medicare beneficiaries.
Section 1861(iii)(3)(D) of the Act defines ``qualified home
infusion therapy suppliers'' as being accredited by a CMS-approved AO.
In the proposed rule, we proposed to establish regulations for the
approval and oversight of AOs that accredit home infusion therapy
suppliers to address the following: (1) The required components to be
included in a home infusion therapy AO's initial or renewal application
for CMS approval of the AO's home infusion therapy accreditation
program; (2) the procedure for CMS' review and approval of a home
infusion therapy AOs application for CMS approval of its home infusion
therapy accreditation program; and (3) the process for ongoing
monitoring and oversight of the CMS-approved home infusion therapy AOs.
Comment: Another commenter stated that they were slightly confused
by the use of this proposed rule as the appropriate forum for these
significant changes.
Response: The issues presented in the proposed rule involve the
payment for home infusion therapy services, the accreditation of
suppliers that provide home infusion therapy services to patients in
their homes and the approval and oversight of AOs that accredit home
infusion therapy suppliers. Most of the AOs that currently provide
accreditation for home infusion therapy suppliers are AOs that also
accredit Home Health Agencies (HHAs). Further, the home infusion
therapy accreditation offered by these HHA AOs is currently provided as
part of these HHA AO's home health accreditation program. Therefore, we
believe that the Home Health Prospective Payment System (HH PPS) rule
is an appropriate venue in which to present these issues.
Comment: Several commenters stated general support for the
establishment of an accreditation program for home infusion therapy
suppliers. One of these commenters stated that home infusion therapy is
a service that can be safely and effectively provided in the home
setting, when provided by an accredited home infusion therapy supplier
under a physician ordered plan of care. Several commenters stated
general agreement with the AO approval and oversight provisions for
home infusion therapy AOs but suggested that the health and safety
standard regulations need to include additional provisions including
pharmacy safety standards such the requirements for sterile
compounding.
Response: We thank these commenters for their support of these
proposals. We refer those commenter that suggested changes or additions
to the home infusion therapy health and safety standards to section
VI.B. of this for further discussion of these comments.
Comment: Several commenters stated that the accreditation section
of the rule is silent as to when CMS plans on making accreditation a
requirement of participation for reimbursement. These commenters
requested that CMS provide clarity on the effective date of this
requirement.
Response: Section 1834(u)(5)(B) of the Act requires that ``not
later than January 1, 2021, the Secretary shall designate organizations
to accredit suppliers furnishing home infusion therapy''. The permanent
home infusion therapy benefit provided under the 21st Century Cures Act
is to begin on January 1, 2021. Therefore, all home infusion therapy
suppliers must be accredited by no later than January 1, 2021 in order
to receive Medicare payment for furnishing home infusion therapy
services under the permanent home infusion therapy benefit. CMS plans
to publish a solicitation notice in the Federal Register which will
announce that we are seeking national AOs to accredit home infusion
therapy suppliers and invite interested AOs to submit their
applications to CMS. We plan to publish this solicitation notice very
soon after publication of the final rule. We will be prepared to begin
accepting applications from prospective AOs seeking CMS approval of a
home infusion therapy accreditation program immediately after
publication of the solicitation notice.
Comment: A commenter stated the opinion that ``the accreditation
section of the rule is a statutory construct of the 21st Century Cures
Act as a requirement to become a qualified home infusion provider for
the permanent home infusion services reimbursement.'' This commenter
further stated the belief that ``the BBA does not require accreditation
[[Page 56565]]
to become a ``qualified'' home infusion therapy supplier and relies on
a qualified home infusion provider to be a qualified home infusion
provider and a pharmacy enrolled in the DME program and a pharmacy
licensed in the state where applicable home infusion drugs are
administered.''
Response: Section 50401 of the Bipartisan Budget Act (BBA) of 2018
does not specifically state accreditation is required to become a
``qualified'' home infusion therapy for payment of the temporary
transitional home infusion therapy services. However for the permanent
home infusion therapy services benefit, section 5012 of the 21st
Century Cures Act added section 1861(iii)(3)(D)(i) to the Act that
defines the term 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 or
services or supplier furnishes items or services and that . . . .
``(III) is accredited by an organization designated by the Secretary
pursuant to section 1834(u)(5) . . .''. Further, this statutory
provision does not restrict ``qualified'' home infusion therapy
suppliers to only pharmacies, but includes physicians, other providers
of services and suppliers as possible types of home infusion therapy
suppliers. However, section 50401(a) of the BBA of 2018, adding new
section 1834(u)(7)(F) to the Act, requires that ``eligible home
infusion suppliers'' for the temporary transitional payment be 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.
Accreditation for home infusion therapy services is not required for
these pharmacies.
Comment: Another commenter requested that CMS clarify that all
eligible accrediting organizations may submit an application to CMS for
approval of a home infusion therapy accreditation program and not just
the eight AOs listed in the proposed rule.
Response: Regarding comments on the eight AOs listed in the
proposed rule, since publication of the proposed rule, we are made
aware of two additional AOs for home infusion therapy suppliers. The
eight existing AOs that provide home infusion therapy accreditation
are: (1) The Joint Commission; (2)Accreditation Commission for
Healthcare (ACHC); (3) Community Health Accreditation Partner (CHAP);
(4) The Compliance Team (TCT); (5) National Association of Pharmacy
Boards (NAPB); (6) Healthcare Quality Association on Accreditation
(HQAA); (7) The Centers for Pharmacy Practice Accreditation (CPPA) and
(8) URAC. In accordance with this final rule with comment period, any
national AO that provides accreditation for home infusion therapy
suppliers that meets the following requirements may submit an
application to CMS requesting approval of their home infusion therapy
accreditation program: (1) The AO must be national in scope; (2) the AO
must have a home infusion therapy accreditation program that is
separate and distinct from other accreditation programs they have; (3)
the AO must have home infusion therapy accreditation standards that
meets or exceeds the Medicare home infusion therapy health and safety
standards to be codified at 42 CFR 486.500 to 486.525; and (4) the home
infusion therapy AO must accredit only those home infusion therapy
suppliers that provide all services required by the Medicare home
infusion therapy health and safety and payment regulations.
Upon receipt of an application from a home infusion therapy AO
seeking CMS approval of its home infusion therapy accreditation
program, CMS will determine its completeness in accordance with the
requirements set forth at Sec. 488.1010(a). Once CMS has determined
that an application is complete, CMS will then review it to determine
whether the application meets the requirements set forth at Sec.
488.1000 to Sec. 488.1050 and whether the AOs accreditation standards
meet or exceed the Medicare home infusion therapy health and safety
accreditation requirements set forth at proposed Sec. 486.500 to Sec.
486.525. CMS will also assess whether the AO accredits only those home
infusion therapy suppliers that provide all services required by the
Medicare home infusion therapy health and safety and payment
regulations. Pursuant to Sec. 488.1010(d), CMS must complete the
application review process and issue a decision within 210 days from
the date that CMS determines that the application is complete. In
accordance with Sec. 488.1020(b), CMS will publish a final notice in
the Federal Register announcing our decision to approve or deny a
national accrediting organization application. The notice will specify
the basis for the CMS decision.
Comment: Several commenters raised the question of whether the
National Association of Boards of Pharmacy (NABP), which is one of the
existing AOs that provide accreditation to home infusion therapy
suppliers, would qualify as a CMS-approved home infusion therapy AO.
These commenters stated that the NABP's survey process focuses only on
pharmacy personnel education, practice of pharmacy including sterile
compounding, patient counseling. These commenters further stated that
the NABP addresses sterile compounding in their standards but does not
address the plan of care process, the complexities of patient care
monitoring or any professional staff components. These commenters
further stated that they do not consider NABP a full-service home
infusion accreditation organization and few third party payers in the
private sector accept or recognize NABP alone as sufficient
accreditation for home infusion. These commenters expressed the opinion
that they want the industry to be held to a higher standard than what
NABP accreditation provides.
Response: Any national AO that provides accreditation for home
infusion therapy suppliers that meets the requirements set forth
previously may submit an application to CMS requesting approval of a
home infusion therapy accreditation program. In addition, we cannot
predetermine whether the NABP would qualify as a CMS-approved home
infusion therapy AO nor can we prohibit any organization from applying
to be an AO.
Upon receipt of an application, CMS will determine its completeness
in accordance with the requirements set forth at Sec. 488.1010(a).
Once CMS has determined that the application is complete, CMS will
review it to determine whether the application meets the requirements
set forth at Sec. 488.1000 to Sec. 488.1050 and whether the AOs
accreditation standards meet or exceed the Medicare home infusion
therapy health and safety accreditation requirements set forth at
proposed Sec. 486.500 to Sec. 486.525. CMS will also assess whether
the AO accredits only those home infusion therapy suppliers that
provide all services required by the Medicare home infusion therapy
health and safety and payment regulations. Pursuant to Sec.
488.1010(d), CMS must complete the application review process and issue
a decision within 210 days from the date CMS determines that the
application is complete. In accordance with Sec. 488.1020(b), CMS will
publish a final notice in the Federal Register announcing our decision
to approve or deny a national accrediting organization's application.
The final notice will specify the basis for CMS' decision.
If the NABP were to submit an application to CMS for approval of a
home infusion therapy accreditation program, we would be required to
give the same consideration to that
[[Page 56566]]
application as we would give to any other application we receive. We
would be required to review the application to determine whether the
NABP's home infusion therapy accreditation program meets the previously
stated requirements. We would also be required to review the
application to determine whether the NABP's application meets the
requirements set forth is Sec. 488.1010.
It is interesting to point out that these same commenters strongly
advocated for CMS to ``grandfather'' in the existing eight home
infusion therapy AOs which were recognized in the proposed rule. These
commenter's argued that for CMS to do otherwise would be to defeat
Congress's clear direction and understanding that the accreditation
program be functional by January 1, 2019, and would severely disrupt
care for patients. As the NAPB is one of eight existing home infusion
therapy accrediting organizations, it would seem that these commenters
have on one hand, advocated that the NABP should ``grandfathered'' in
as one of the eight existing home infusion therapy AOs, while also
advocating for their exclusion as a home infusion therapy AO. These
arguments conflict with one another.
Comment: Several commenters expressed the belief that the HHA AOs
with an existing home infusion therapy accreditation program should not
be required to have a Home Infusion therapy accreditation program that
is separate and distinct from their HHA accreditation programs because
this would place unnecessary burden on these HHA AOs. These commenters
stated their disagreement with CMS' proposal that the home infusion
therapy benefit should fall under an entirely separate accreditation
process from an existing home care program. These commenters strongly
recommended that CMS allow HHA AOs to satisfy the specified home
infusion therapy accreditation requirement within their home care
programs. In support of this request, a commenter stated the belief
that including home infusion therapy services as part of the larger
home health accreditation would promote a higher quality of care as
well as a more coordinated and comprehensive approach to care delivery.
Several commenters suggested that the accreditation of home
infusion therapy suppliers should be allowed as part of an HHA AO's
overall accreditation and not require a totally separate accreditation
as long as the accreditation organization meets all the CMS mandated
home infusion therapy accreditation health and safety standards. Some
of these commenters stated the belief that requiring AOs with existing
home infusion therapy accreditation programs to submit a home infusion
therapy accreditation program that is separate and distinct from their
HHA accreditation program could affect the quality of care provided by
these AOs and that such a policy would further fragment care delivery.
Another commenter suggested that CMS should permit a separate home
infusion therapy accreditation module, approved by CMS, under an
existing accreditation program because CMS has already done
considerable review of the existing HHA accreditation programs and
could benefit from working with the AOs to build on already existing
standards to establish a standard set of standards that could be
included for all accreditation organizations rather than developing a
totally separate, free-standing home infusion therapy accreditation
program.
Several commenters stated the belief that the requirement for a
distinct, freestanding accreditation program for home infusion therapy
suppliers would place additional burden on home care programs that
currently provide home infusion therapy services as well as on
accrediting organizations (AOs). One of these commenters expressed the
concern that a totally separate accreditation program for HIT only
would involve excessive cost and personnel time for agencies and CMS.
Response: We believe that it would not be permissible for CMS to
allow the Home Health accrediting organizations to maintain the home
infusion therapy accreditation program as part of their overall HHA
accreditation program for several reasons. First, sections
1861(iii)(3)(D)(i) and 1834(u)(5) of the Act are clear that an
accreditation is required for qualified home infusion therapy suppliers
and that CMS must approve AOs accrediting these suppliers. Pursuant to
section 1834(u)(5)(B) of the Act, CMS is mandated to designate AOs to
accredit home infusion therapy suppliers by no later than January 1,
2021. This statutory mandate does not include language that would allow
CMS to approve existing home infusion therapy accreditation programs
that are co-mingled with other accreditation programs.
Second, given that our review of the commenter's HHA accreditation
program standards occurred prior to the passage of the statutory
mandate for CMS to designate AOs to accredit home infusion therapy
suppliers our review of AOs' HHA programs focus on and assess the AO's
HHA accreditation program standards and adherence to the CMS Home
Health Conditions of Participation. Therefore, the reliance on our
previous review of the HHA accreditation program standards and survey
processes would not be sufficient to ensure that a HHA AO's home
infusion therapy accreditation program would meet or exceed Medicare
home infusion therapy health and safety standards that we are
finalizing in this rule.
In addition, in this rule, we have proposed to establish new home
infusion therapy health and safety accreditation standards that each
home infusion therapy AO must incorporate into their home infusion
therapy accreditation standards. When we reviewed the HHA AOs previous
application, this review would have occurred prior to the publication
of the CY 2019 Home Health proposed rule. Therefore, the HHA AOs could
not yet have incorporated the new home infusion therapy health and
safety standards into the accreditation standards they submitted with
their applications. The establishment of the Medicare home infusion
therapy health and safety accreditation standards will require that the
existing home HHA/home infusion therapy AOs revise their home infusion
therapy accreditation standards to ensure that they meet or exceed
these new home infusion therapy health and safety standards. Therefore,
we must require that each of the existing HHA/home infusion therapy AOs
submit for our review, a new application seeking approval for a
separate and distinct accreditation program for home infusion therapy
suppliers, to ensure that the accreditation standards used meet or
exceed the Medicare home infusion therapy health and safety standards.
Comment: Several commenters have stated that CMS should allow home
health agency AOs to continue to provide home infusion accreditation
services as part of their larger home health accreditation program.
These commenters believe that providing home infusion therapy
accreditation services as part of the AO home health program would both
promotes higher quality care for beneficiaries and reduce
administrative burden.
Response: We respectfully disagree with these commenters, because
the commenters have provided no specific facts or circumstances which
would explain how having a separate and distinct home infusion therapy
accreditation program would promote a higher quality of care.
Moreover, the statutory requirement of section 1834(u)(5) of the
Act
[[Page 56567]]
contemplates an independent accreditation process for home infusion
therapy suppliers.
Comment: Several commenters stated concern that it would be too
burdensome to require HHA AOs with existing home infusion therapy
accreditation programs to develop a new home infusion therapy
accreditation program that is distinct from their existing HHA
accreditation program.
Response: We respectfully disagree with these commenters. We
believe the additional burden will be minimal. Moreover, the statute
mandates an AO program and application process that is structurally
separate from accreditation for HHAs. While these commenters may incur
some initial burden to create a home infusion therapy accreditation
program that is separate and distinct from their home health
accreditation program, we believe that this burden would be limited for
several reasons. First, these commenters have stated in their comments
that they do have established home infusion therapy standards and
survey processes but that they are co-mingled with the AOs home health
accreditation standards and survey processes. As these home health AOs
already have established home infusion therapy accreditation standards
and survey processes, we believe that it would be an uncomplicated
matter for these AOs to separate their home infusion therapy standards
and survey processes from their home health accreditation standards and
survey processes. What we mean by this is that the AO could simply take
the documents which contains the combined home health/home infusion
therapy accreditation standards and survey processes and cut and paste
the home infusion therapy accreditation language into a separate
document. This task would only need to be performed once. Further, we
believe the benefits of having a home infusion therapy accreditation
program that is separate and distinct from the home health AOs home
health accreditation program far outweighs the burden associated with
the initial separation of the home infusion therapy accreditation
program and home health accreditation program standards and survey
processes.
Comment: Another commenter pointed out that ``HHAs have
historically provided professional services associated with home
infusion to individuals under their care, and further stated that they
applauded both Congress and CMS for moving forward in implementing this
important benefit and the additional support and resources it
represents.'' However, several other commenters stated that home health
agencies do not own or operate pharmacies, prepare home infusion drugs,
provide the care coordination necessary to manage drug infusion, or
provide a home infusion benefit. These commenters further stated that
home infusion providers are neither certified nor authorized to offer
the myriad of care services required of a home health agency. Thus,
there is no relationship, overlap or intersection between the two
benefits. Home health agencies will continue to provide the home health
benefit for Medicare patients, and home infusion pharmacies will
provide the new separate home infusion benefit for their Medicare
patients.
Response: We agree with this commenter and we believe that HHAs are
in a unique position to provide both home infusion therapy services and
home health services to patients in their homes. Under the Medicare
home infusion therapy benefit in section 1861(iii) of the Act, as added
by section 5012 of the Cures Act, home infusion therapy services are
available for those individuals receiving eligible home infusion drugs.
Eligible home infusion therapy drugs are defined under section
1861(iii)(3)(C) of the Act, as a 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. The services that are to be provided and paid for by
Medicare do not include the provision of the home infusion drug, DME
infusion pump, or supplies therefore, it is not necessary for a home
infusion therapy supplier to be a licensed pharmacy.
Comment: Several commenters expressed the opinion that CMS has
delayed in proposing the home infusion therapy AO regulations, and that
this has caused the likelihood that the home infusion therapy AOs will
be unable to apply for CMS approval, much less that CMS will have
completed the accreditation process for home infusion AOs, prior to
January 1, 2019. These commenters urged CMS to ``grandfather'' in
existing accreditations to entities such as the eight AOs recognized in
the proposed rule. The commenters suggest that for CMS to do otherwise
would be to defeat Congress's clear direction and understanding that
the accreditation program be functional by such date, and would
severely disrupt care for patients. These commenters stated the belief
that such action would be consistent with section 1834(u)(7)(F) of the
Act, as added by section 50401 of the BBA of 2018, where Congress
expressed its acceptance of such accreditation as sufficient on January
1, 2019 when the Transition benefit will begin.
Response: We respectfully disagree with these commenters'
contention that CMS delayed in proposing the home infusion therapy AO
regulations. The 21st Century Cures Act, which is the legislation that
established the requirement for accreditation of home infusion therapy
suppliers, was signed into law December 13, 2016. Thereafter, time was
required to develop our plan for implementation, which occurred through
mid to late 2017. By the time that the implementation planning phase
was completed, the CY 2018 Home Health Prospective Payment proposed and
final rules had already been published. Therefore, the CY 2019 Home
Health Prospective Payment System Proposed Rule was the first
appropriate venue in which CMS could make these proposals. Moreover,
section 1834(u)(5)(B) of the Act, as added by the 21st Century Cures
Act, requires that ``[n]to later than January 1, 2021, the Secretary
shall designate organizations to accredit suppliers furnishing home
infusion therapy.'' This means that it was intended that CMS would have
until January 1, 2021 to solicit and approve AOs to accredit home
infusion therapy suppliers for the permanent Medicare home infusion
therapy services benefit for which payment to qualified home infusion
therapy supplier will begin on January 1, 2021.
As stated in the proposed rule, we plan to publish a solicitation
notice seeking national AOs to accredit home infusion therapy suppliers
shortly after publication of the final rule. In addition, Sec.
488.1010(d) requires CMS to complete its review of an application
submitted by a home infusion therapy AO within 210 calendar days from
the date that CMS determines that an application is complete. If we
publish the solicitation notice by December 31, 2018 and receive
applications from prospective home infusion therapy AOs during the
first 5 months of 2019, we would be required to complete our review of
these applications and issue our decisions by December 31, 2019, which
is 1 full year before the January 1, 2021 deadline. Assuming we publish
the solicitation notice by December 31, 2018, and considering that we
must complete review of the application within 210 days, there would be
a 16-month period in which prospective home infusion therapy AOs could
submit their application for CMS review and obtain approval by the
January 1, 2021 deadline specified in section 1834(u)(5)(B) of the Act.
[[Page 56568]]
The existing AOs that have been providing accreditation of home
infusion therapy suppliers already have established home infusion
therapy accreditation programs and accreditation standards. A number of
commenters have stated that their respective home infusion therapy
standards already meet or exceed the CMS proposed home infusion therapy
accreditation health and safety standards and therefore believe that
they should not be required to submit an application to CMS for
approval. However, if this is the case, we believe that it should not
take these AOs long to prepare the information and documentation
required to apply for CMS approval of their home infusion therapy
accreditation programs.
Likewise, we do not believe that it would take a long period of
time for the HHA AOs that accredit home infusion therapy suppliers to
prepare and submit their applications for CMS approval of a separate
and distinct home infusion therapy accreditation program. It is our
understanding from the comments received that these AOs have home
infusion therapy accreditation standards that already meet or exceed
the CMS proposed home infusion therapy accreditation health and safety
standards; however, these home infusion therapy accreditation standards
are integrated into the AO's HHA accreditation program. We believe that
it would be an uncomplicated matter for these HHA AOs to segregate
their home infusion therapy accreditation program into an individual
accreditation program. As these AOs have previously established one or
more accreditation programs and survey processes in the past, and have
prepared and submitted one or more applications to CMS for approval of
these accreditation programs, we believe that it would take these AOs
less time and effort to do so for a separate and distinct home infusion
therapy accreditation program.
Comment: Several commenters expressed the opinion that the
Congressional intent was for CMS to accept the accreditation provided
by the existing home infusion therapy AOs as being sufficient as of
January 1, 2019 when the transitional benefits begin. Several
commenters suggested that section 1834(u)(5)(D) requires CMS to deem
any home infusion supplier accredited by a home infusion therapy AO
designated or otherwise recognized and accepted by CMS prior to January
1, 2019, to be deemed accredited through January 1, 2023.
Response: We do agree that the existing home infusion therapy
accreditation provided by the 8 existing home infusion therapy
accreditation organizations prior to or on January 1, 2019 and still in
effect on January 1, 2021, would be deemed to meet our accreditation
requirements through at least January 1, 2023, once the permanent
program goes into effect on January 1, 2021. Accreditation is not
required for the transitional program set out at 1834(u)(7) of the Act.
CMS cannot designate AOs until after January 1, 2019 (when our
standards and designation procedures become effective).
Section 1834(u)(5)(D) titled ``Rule for Accreditations Made Prior
to Designation'' refers to accreditations of home infusion suppliers
that occurred ``prior to the Secretary's designation'' of AOs. This
provision applies only to those AOs that are ultimately approved by
CMS; the eight AOs currently providing accreditation receive no special
consideration. Should any of the eight apply and be approved, any
supplier with an active accreditation as of January 1, 2019 that is
still active on January 1, 2021, when the accreditation requirement
goes into effect, will be deemed to have a recognized accreditation
until at least January 1, 2023, and longer if their accreditation lasts
for a longer period.
2. Process and Standards for Home Infusion Therapy Accreditation and
the Approval and Oversight of Accrediting Organizations With CMS-
Approved Accreditation Programs for Home Infusion Therapy Services
a. Establishment of Regulatory Requirements
We proposed to establish new regulations in a new subpart L in 42
CFR part 488 that would govern CMS' approval and oversight of AOs that
accredit home infusion therapy suppliers. We believe these new
regulations would provide CMS with reasonable assurance that the home
infusion therapy AO's accreditation program requirements are consistent
with the appropriate Medicare accreditation program requirements.
Further, we believe that these proposed regulations would provide CMS
with a way to provide oversight for AOs that accredit home infusion
therapy suppliers, and provide CMS with authority over the home
infusion therapy suppliers.
We proposed to implement a comprehensive, consistent and
standardized set of AO oversight regulations for accreditors of home
infusion therapy suppliers. It is our intention to provide home
infusion therapy AOs with the flexibility to innovate within the
framework of these regulations while assuring that their accreditation
standards meet or exceed the appropriate Medicare requirements, and
their survey processes are comparable to those of Medicare.
``Flexibility to innovate'' means that AOs retain the freedom to
develop their own accreditation standards and survey processes, so long
as the AO ensures that they meet the health and safety standards
(contained in 42 CFR part 486, subpart B) and the AO meets the
requirements of the AO approval and oversight regulations.
The proposed regulations would reflect requirements similar to
those in place for the oversight of national AOs for Medicare-certified
providers and suppliers which are codified at 42 CFR 488.1 through
488.13 and 42 CFR part 489, but would be modified, as appropriate, to
be applicable for accreditors of home infusion therapy suppliers. We
believe that it is important to have AO approval and oversight
regulations that are as consistent as possible across all AOs and to
treat all AOs in a similar manner.
b. Consideration of Existing Regulations
In formulating our approach to implementing the statutory
requirements related to accreditation organizations, we had considered
using the regulations at 42 CFR 488.1 to 488.13 for the approval and
oversight of AOs that accredit home infusion therapy suppliers.
However, we decided not to do so because we believe that Congress, by
setting out separate accreditation organization approval standards for
home infusion therapy suppliers at 1834(u)(5)(A) of the Act, intended
approval for this accreditation program to be a discrete process. We
believe that having a separate set of approval regulations applicable
only to home infusion therapy suppliers will best reflect Congress's
intent.
Only limited portions of the regulations at Sec. Sec. 488.1
through 488.13 will apply to AOs that accredit home infusion therapy
suppliers. For example, Sec. 488.6, regarding accredited provider
entities' participation in Medicaid, will not apply to home infusion
therapy because home infusion therapy suppliers is not a benefit
specified in our Medicaid regulations.
Section 488.7, titled ``Release and use of accreditation surveys''
and Sec. 488.8 titled ``Ongoing review of accrediting organizations''
will have parallel provisions applicable to AOs that accredit home
infusion therapy suppliers (Sec. 488.1025). However, Sec. 488.9
titled ``Validation surveys'' will not have a parallel provision
applicable to
[[Page 56569]]
AOs for home infusion therapy suppliers because the State Survey Agency
(SA) only performs validation surveys for AOs that operate under the
statutory authority of section 1865 of the Act. In addition, section
1864(a) of the Act provides, that by agreement with the Secretary, the
SA shall provide services to the following Medicare certified
healthcare providers: hospitals, skilled nursing facilities, home
health agencies, hospice programs, rural health clinics, critical
access hospitals, comprehensive outpatient rehabilitation facilities,
laboratories, clinics, rehabilitation agencies, public health agencies,
or ambulatory surgical centers. Home infusion therapy suppliers are not
included in this list.
Section 488.10, titled ``State survey agency review: Statutory
provisions'', Sec. 488.11 titled ``State survey agency functions'' and
Sec. 488.12 titled ``Effect of survey agency certification'' will also
not have parallel provisions applicable to home infusion therapy AOs.
This is because, as stated previously, the SA does not perform
validation surveys for AOs that accredit home infusion therapy
providers. Section 488.13, titled ``Loss of accreditation'' provides
that ``if an accrediting organization notifies CMS that it is
terminating a provider or supplier due to non-compliance with its CMS-
approved accreditation requirements, the SA will conduct a full review
in a timely manner.'' This section will also not have parallel
provisions applicable to AOs that accredit home infusion therapy
suppliers because this regulation section requires use of the SA.
Section 488.14 titled, ``Effect of QIO review'' provides that
``when a QIO is conducting review activities under section 1154 of the
Act and part 466 of this chapter, its activities are in lieu of the
utilization review and evaluation activities required of health care
institutions under sections 1861(e)(6), and 1861(k) of the Act.'' This
section will not have parallel provisions applicable to AOs for home
infusion therapy suppliers because it is only applicable only to
hospitals.
Finally, Sec. 488.18, titled ``Documentation of findings'' states
that ``the findings of the State agency with respect to each of the
conditions of participation, requirements (for SNFs and NFs), or
conditions for coverage must be adequately documented.'' As noted
previously, we will not be including a parallel provision applicable to
AOs that accredit home infusion therapy suppliers because it involves
the activities of the SAs, which will not be involved in the home
infusion therapy supplier accreditation process.
In conclusion, a majority of sections contained in Sec. Sec. 488.1
through 488.13 do not apply to home infusion therapy AOs and home
infusion therapy suppliers. Therefore, we have created a separate set
of regulations that are specifically applicable to home infusion
therapy AOs.
We sought comment on our decision not to use the existing
regulation at Sec. Sec. 488.1 through 488.13. We did not receive any
comments on this topic.
c. Consideration of a Validation Process for Accrediting Organizations
That Accredit Home Infusion Therapy Suppliers
Our conventional validation process involves the participation of
the CMS Regional Offices (ROs) to request the State Survey Agency to
conduct an onsite validation (follow-up) survey within 60 days of an
AO's onsite survey. The purpose of a validation survey is to evaluate
the ability of that AO's survey process to identify serious, condition
level deficiencies.
We did not propose to establish a validation program requirement
for home infusion therapy AOs and suppliers due to a number of resource
constraints. Several factors limit our ability to establish and
implement a validation program for home infusion therapy AOs. First, as
mentioned previously, the SAs are not available to perform validation
surveys for home infusion therapy AOs. This is because, pursuant to
section 1864(a) of the Act, the SA, enters into an agreement with the
Secretary to provides services to only a limited number of healthcare
provider types (that is, hospitals, skilled nursing facilities, home
health agencies, hospice programs, rural health clinics, critical
access hospitals, comprehensive outpatient rehabilitation facilities,
laboratories, clinics, rehabilitation agencies, public health agencies,
or ambulatory surgical centers.
We sought public comment on the decision not to propose a
validation process at this time.
Even though we would not have a formal validation process in place,
we would be able to monitor the performance of the home infusion
therapy AOs as part of the ongoing AO oversight process provided for in
the home infusion therapy AO approval and oversight regulations at
Sec. Sec. 488.1010 through 488.1050. For example, under proposed Sec.
488.1030 we would have the ability to carry out performance reviews to
evaluate the performance of each CMS-approved home infusion therapy
accreditation program on an ongoing basis; comparability reviews to
assess the equivalency of a home infusion therapy AO's CMS-approved
program requirements with the comparable Medicare home infusion therapy
accreditation requirements after CMS imposes new or revised Medicare
accreditation requirements; and standards reviews when a home infusion
therapy accrediting organization proposes to adopt new or revised
accreditation standards. We may also perform CMS-approved home infusion
therapy accreditation program review if a comparability, performance,
or standards review reveals evidence of substantial non-compliance of a
home infusion therapy AO's CMS-approved home infusion therapy
accreditation program with the requirements of this subpart. (See Sec.
488.1005 for a definition of ``substantial non-compliance'').
In addition, proposed Sec. 488.1035 would require the home
infusion therapy AOs to submit information to CMS which would help us
monitor the AO's performance. This information would also help to
ensure that the home infusion therapy suppliers accredited by the AO
provide care that meets the health and safety standards contained in 42
CFR part 486, subpart B. This information includes the following:
Copies of all home infusion therapy supplier accreditation
surveys, together with any survey-related information.
Notice of all accreditation decisions.
Notice of all complaints related to the AO's accredited
suppliers.
Information about all home infusion therapy accredited
suppliers against which the home infusion therapy accreditation
organization has taken remedial or adverse action, including
revocation, withdrawal, or revision of the providers or suppliers
accreditation.
Annual basis, summary data specified by CMS that relate to
the past year's accreditation activities and trends.
Notice of any changes in the home infusion therapy
accrediting organization's accreditation standards or requirements or
survey process.
Comment: Several commenters agreed with CMS that validation surveys
should not be required for home infusion therapy AOs. One of these
commenters agreed with CMS' position that the performance reviews
performed under proposed Sec. 488.1030 would provide more objective
and effective data about the AOs performance.
Response: We thank these commenters for their input.
Final Decision: In consideration of the comments received, we are
finalizing this proposal without modification and
[[Page 56570]]
will perform ongoing monitoring as part of the approval and ongoing
oversight process for home infusion therapy AOs.
d. Application Requirement for AOs That Currently Provide Accreditation
for Home Infusion Therapy Suppliers
We proposed to establish regulations for the approval and oversight
of AOs for home infusion therapy suppliers. We also proposed the health
and safety standards which home infusion therapy suppliers must meet,
and which the home infusion AOs must meet or exceed in their
accreditation standards. These health and safety standards are being
set forth in this final rule with comment period at 42 CFR part 486,
subpart I. The AOs that currently accredit home infusion therapy
suppliers have not heretofore been governed by any CMS regulations
related to home infusion therapy accreditation or health and safety
standards. These AOs have each created their own set of accreditations
standards. These accreditation standards vary from AO to AO.
Section 1834(u)(5)(C) of the Act requires home infusion therapy
suppliers to be accredited in order to receive payment for the services
they provide. We proposed to require that the home infusion therapy
accreditation program submitted to CMS for approval by each of the AOs
that currently accredit home infusion therapy suppliers be separate and
distinct accreditation programs that are not part of the AOs home
health accreditation program. We proposed to further require that the
AOs home infusion therapy accreditation standards meet or exceed the
health and safety standards for home infusion therapy suppliers.
Finally, we would require that the application meet the requirements of
proposed 42 CFR 488.1010.
e. Oversight of Home Infusion Therapy Accrediting Organizations
As noted previously, we proposed to create a new set of regulations
titled, ``Approval and Oversight of Home Infusion Therapy Supplier
Accrediting Organizations'' at 42 CFR part 488, subpart L. These
proposed regulations would set forth the application and reapplication
procedures for national AOs seeking approval or re-approval of
authority to accredit home infusion therapy suppliers; ongoing CMS
oversight processes for approved AOs that accredit home infusion
therapy suppliers; and, appeal procedures for AOs that accredit home
infusion therapy suppliers. In this section of the final rule, we
describe our regulatory provisions.
The following sections discuss the regulations, in their order.
(1) Basis and Scope (Sec. 488.1000)
We proposed at Sec. 488.1000 to set forth the statutory authority
related to this set of regulations. Sections 1834(u)(5) and 1861(iii)
of the Act would be the statutory basis for these regulations. These
sections of the Act provide the Secretary with the authority necessary
to carry out the administration of the Medicare program. Section 1861
of the Act defines services, supplier types and benefits, and over whom
Medicare may have authority. Section 1861(d) defines the term
``supplier.'' Section 1834(u)(5) of the Act governs accreditation of
home infusion therapy suppliers.
Section 1861(iii)(3)(D)(i)(III) of the Act requires that home
infusion therapy suppliers be accredited by an organization designated
under section 1834(u)(5) of the Act. Section 1834(u)(5) of the Act
requires that the Secretary establish factors in designating
accrediting organizations and designate accrediting organizations to
accredit suppliers furnishing home infusion therapy by January 1, 2021.
Proposed Sec. 488.1000(a) would set forth the statutory authority
for the accreditation of home infusion therapy suppliers by the home
infusion therapy AOs. Title 42 CFR 488.1000(b) would set forth the
scope of the regulation, which is the application and reapplication
procedures for national AOs seeking approval or re-approval of
authority to accredit home infusion therapy suppliers; ongoing CMS
oversight processes for approved of home infusion therapy AOs; and,
appeal procedures for AOs of home infusion therapy suppliers.
(2) Definitions (Sec. 488.1005)
We proposed the following definitions:
``Accredited home infusion therapy supplier'' means a
supplier that has demonstrated substantial compliance with a CMS-
approved national home infusion therapy AO's applicable CMS-approved
home infusion therapy accreditation program standards, which meet or
exceed those of Medicare, and has been awarded accreditation by that
AO.
``Qualified home infusion therapy supplier'' means an
entity that meets the following criteria which are set forth at
1861(iii)(3)(D)(i): (1) Furnishes infusion therapy to individuals with
acute or chronic conditions requiring administration of home infusion
drugs; (2) ensures the safe and effective provision and administration
of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; (3) is
accredited by an organization designated by the Secretary pursuant to
section 1834(u)(5); and (4) meets such other requirements as the
Secretary determines appropriate.
``Immediate jeopardy'' means a situation in which the
provider's or supplier's non-compliance with one or more Medicare
accreditation requirements has caused, or is likely to cause, serious
injury, harm, impairment, or death to a patient, as codified at Sec.
488.1.
``National accrediting organization'' means an
organization that accredits supplier entities under a specific program
and whose accredited supplier entities under each program are widely
dispersed geographically across the United States. In addition, the
specific program is active, fully implemented, and operational. This
definition is codified at Sec. 488.1.
``Reasonable assurance'' means an AO has demonstrated to
CMS' satisfaction that its accreditation program requirements meet or
exceed the Medicare program requirements. This definition is codified
at Sec. 488.1.
``Rural'' area means an area as defined at section
1886(d)(2)(D) of the Act.
``Substantial allegation of non-compliance'' means a
complaint from any of a variety of sources (such as patient, relative,
or third party), including complaints submitted in person, by
telephone, through written correspondence, or in the newspaper,
magazine articles or other media, that will, if found to be present,
adversely affect the health and safety of patients and raises doubts as
to a supplier's compliance with any of the Medicare home infusion
therapy accreditation requirements. This definition is codified at
Sec. 488.1.
(3) Application and Reapplication Procedures for National Accrediting
Organizations (Sec. 488.1010)
Proposed Sec. 488.1010 would contain application and re-
application procedures for all national AOs seeking CMS-approval of an
accreditation program for home infusion therapy suppliers. Proposed
Sec. 488.1010(a) would provide a comprehensive listing of the
information, supporting documentation, certifications, written
statements and other data that prospective AOs for home infusion
therapy suppliers would be required to include in their application for
approval to accredit home infusion therapy suppliers. The proposed
requirements under this section would apply to both initial
applications for CMS-approval as well as applications for re-approval
of an
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existing CMS-approved home infusion therapy accreditation program. This
proposed provision would also require the AOs for home infusion therapy
supplies to furnish CMS with information that demonstrates that their
accreditation program requirements meet or exceed the applicable
Medicare requirements.
Proposed Sec. 488.1010(a)(1) requires AOs for home infusion
therapy suppliers seeking initial or renewed CMS-approval of their home
infusion therapy accreditation program to demonstrate that they meet
the definition of a ``national accrediting organization.'' Section 1865
of the Act requires that accrediting organizations be national in
scope.
Proposed Sec. 488.1010(a)(2) requires AOs to specifically identify
the Medicare supplier type for which they are requesting CMS-approval
or reapproval.
Proposed Sec. 488.1010(a)(3) requires AOs to demonstrate their
ability to take into account the capacities of home infusion therapy
suppliers in rural areas (as defined in section 1834(u)(5)(A)(ii) of
the Act.
Proposed Sec. 488.1010(a)(4) requires the home infusion therapy AO
to provide information that documents their knowledge, expertise, and
experience in the healthcare field for which they offer accreditation
and for which they are requesting approval.
Proposed Sec. 488.1010(a)(5) requires the AO to submit a detailed
crosswalk (in table format) that identifies, for each of the applicable
Medicare health and safety requirements, the exact language of the
accrediting organization's comparable accreditation requirements and
standards. This proposed requirement would allow CMS to evaluate
whether the accreditation program standards meet or exceed the
applicable Medicare requirements.
Proposed Sec. 488.1010(a)(6) requires each AO for home infusion
therapy suppliers to provide a detailed description of its survey
process. This requirement is intended to allow CMS to gain a better
understanding of an AO's survey process and ensure that its survey and
enforcement processes are comparable to Medicare's health and safety
standards (contained in 42 CFR part 486, subpart I).
Proposed Sec. 488.1010(a)(7)(ii) requires home infusion therapy
AOs that use offsite audits, or other evaluation strategies to evaluate
the quality of services provided by a home infusion therapy supplier,
to follow up these offsite audits with periodic onsite visits. We
believe that it is very important for the AOs that accredit home
infusion therapy suppliers to follow-up off-site survey reviews with
periodic on-site visits to ensure that the home infusion therapy
supplier is complying with all accreditation standards and meeting all
health and safety regulations.
We proposed at Sec. 488.1010(a)(8), to require an AO for home
infusion therapy suppliers to provide a description of the criteria for
determining the size and composition of the onsite survey or offsite
audit teams or teams used for other accreditation evaluation
strategies.
We proposed at Sec. 488.1010(a)(9) to require that an AO for home
infusion therapy suppliers provide CMS with information regarding the
overall adequacy of the number of surveyors, auditors, and other staff
available to perform all survey related activities. Under this section,
the home infusion therapy AO would also be required to provide an
explanation as to how it will maintain an adequate number of trained
surveyors on staff. The home infusion therapy AO must also describe its
ability to increase the size of survey, audit, and other survey program
staff to match growth in the number of accredited home infusion therapy
suppliers while maintaining re-accreditation intervals for existing
accredited home infusion therapy suppliers.
We proposed at Sec. 488.1010(a)(10) to require that an AO for home
infusion therapy suppliers provide CMS with detailed information about
the individuals who perform survey activities, including onsite
surveys, offsite audits and other review processes, for the purpose of
ensuring accredited home infusion therapy suppliers maintain adherence
to the accreditation program requirements.
Proposed Sec. 488.1010(a)(11) requires each AO for home infusion
therapy suppliers to describe the content, frequency and types of in-
service training provided to survey and audit personnel.
We proposed at Sec. 488.1010(a)(12) to require AOs for home
infusion therapy suppliers to provide documentation which describes the
evaluation systems used to monitor the performance of individual
surveyors, survey teams, and staff that perform audit activities. This
requirement will provide CMS with insight into how each home infusion
therapy AO measures the performance of their surveyors, survey teams
and staff that perform audit activities.
We proposed at Sec. 488.1010(a)(13) to require the AO for home
infusion therapy suppliers to provide the organization's policies and
procedures for avoiding and handling conflicts of interest, including
the appearance of conflicts of interest, involving individuals who
conduct surveys, audits or participate in accreditation decisions.
Proposed Sec. 488.1010(a)(14) requires the AO for home infusion
therapy suppliers to provide CMS with documentation of its policies and
procedures for handling disputes filed by a home infusion therapy
supplier regarding survey or audit findings, or an adverse decision.
We proposed at Sec. 488.1010(a)(15) requires that home infusion
therapy AOs provide CMS with copies of the policies and procedures to
be used when an accredited home infusion therapy supplier either--(1)
removes or ceases furnishing services for which they are accredited; or
(2) adds home infusion therapy services for which they are not
accredited.
We proposed at Sec. 488.1010(a)(16) to require the home infusion
therapy AOs to provide CMS with the organization's policies and
procedures for responding to and investigating complaints and
grievances against accredited suppliers.
We proposed at Sec. 488.1010(a)(17) to require that the home
infusion therapy AOs furnish a description of the AO's accreditation
status decision-making process.
We proposed at Sec. 488.1010(a)(18) to require a home infusion
therapy AOs to provide CMS with a list of all home infusion therapy
suppliers currently accredited by that home infusion therapy AO.
We proposed at Sec. 488.1010(a)(19) to require that the home
infusion therapy AOs provide CMS with a schedule of all survey activity
(including but not limited to onsite surveys, offsite audits and other
types if survey strategies), expected to be conducted by the home
infusion therapy AO during the 6-month period following submission of
the application.
We proposed at Sec. 488.1010(a)(20) to require that the home
infusion therapy AO submit a written statement or document that
demonstrates the organization's ability to furnish CMS with the
electronic data the home infusion therapy AO must report to CMS as
required by proposed Sec. 488.1035.
We proposed at Sec. 488.1010(a)(21) to require that the home
infusion therapy AO provide a description of the organization's data
management and analysis system with respect to its surveys and
accreditation decisions.
We proposed at Sec. 488.1010(a)(22) to require the home infusion
therapy AO to furnish the three most recent annual
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audited financial statements from their organization.
We proposed at Sec. 488.1010(a)(23) to require the home infusion
therapy AOs to provide a written statement, in which the home infusion
therapy AO acknowledges, as a condition for approval, that the
organization agrees to the items set forth in Sec. 488.1010(a)(23)(i)
through (vi).
Proposed Sec. 488.1010(a)(23)(i) requires the home infusion
therapy AO to provide a written statement acknowledging that, as a
condition for approval, that if the home infusion therapy AO decides to
voluntarily terminate its accreditation program, the home infusion
therapy AO must provide written notification to CMS and all home
infusion therapy suppliers accredited by that AO. This written notice
must be provided at least 180 calendar days in advance of the effective
date of the home infusion therapy AOs decision to voluntarily terminate
its CMS-approved accreditation program.
Proposed Sec. 488.1010(a)(24) requires the home infusion therapy
AOs to provide CMS with a listing of the organization's fees for home
infusion therapy accreditation. The home infusion therapy AO must
notify CMS of any plans for reducing the burden and cost of
accreditation to small or rural home infusion therapy suppliers. While
CMS does not undertake to set or regulate the fees charges by a home
infusion therapy AO, we do review fees charged by AOs to determine
whether they are reasonable as directed by sections 1834(u)(5)(A)(iii)
of the Act.
Proposed Sec. 488.1010(b) requires home infusion therapy AOs to
agree to submit any additional information, documentation, or
attestations, including items not previously listed that CMS may deem
necessary to make a determination for approval or denial of the home
infusion therapy AO's application. Should we require this additional
information, we would notify the home infusion therapy AO of the
request and provide the home infusion therapy AO with a reasonable
timeframe to submit the requested information.
We proposed at Sec. 488.1010(c) to allow a home infusion therapy
AO to withdraw its initial application for CMS's approval of its home
infusion therapy accreditation program at any time before we publish
the final Federal Register notice described at proposed Sec.
488.1020(b). Proposed Sec. 488.1020(b) requires that the final notice,
published by CMS, specify the basis for our decision.
Proposed Sec. 488.1010(d) requires CMS to complete its review of
an application submitted by a home infusion therapy AO within 210
calendar days from the date that CMS determines that the application is
complete. We proposed that to determine completeness, each application
would be assigned to a technical review team upon receipt by CMS.
We sought public comment on the application requirements set forth
in Sec. 488.1010. We further sought comments on the burden related to
the requirements of the application procedure. We received the
following public comments:
Comment: Several commenters expressed general concern about the
time and cost burden that would be incurred by a home infusion therapy
AO related to obtaining CMS approval for their accreditation program.
Another commenter questioned what the additional time and cost burden
to home infusion therapy AOs for the ongoing administration of their
home infusion therapy accreditation program, after CMS approval is
obtained.
Response: While we understand that there would be some time and
cost burden associated with the accreditation process for home infusion
therapy AOs, this burden is necessary because the CMS approval process
is required by section 1834(u)(5)(B) of the Act which requires the
Secretary to designate AOs to accredit home infusion therapy suppliers
furnishing home infusion therapy not later than January 1, 2021.
Comment: Several home infusion therapy suppliers expressed concern
that the additional or increased operational costs incurred by new of
existing home infusion therapy AOs (such as training, staff wages,
revision of accreditation standards to meet the new Medicare home
infusion therapy health and safety standards, preparation of the
application for CMS seeking CMS approval of the AOs home infusion
therapy accreditation program meet new and/or different accreditation
standards, etc.) are likely that these standards and associated costs
will vary among AOs.
Response: While we understand that there would be some time and
cost burden associated with the accreditation process for home infusion
therapy AOs, this burden is necessary because the CMS approval process
is required by section 1834(u)(5)(B) of the Act which requires the
Secretary to designate AOs to accredit home infusion therapy suppliers
furnishing home infusion therapy not later than January 1, 2021.
Comment: Several commenters urged CMS to amend proposed Sec.
488.1010(a)(23)(i) to require an AO to provide home infusion therapy
suppliers with a 180 day notice, rather than a 90 day notice of the
AO's voluntary withdrawal from the CMS accreditation program. These
commenters stated the belief that the 90 day notice requirement would
be too short a period of time for an otherwise compliant home infusion
therapy supplier to secure new accreditation from a different CMS-
approved home infusion therapy AO.
Response: We believe that, in most cases, an home infusion therapy
AO that has decided to voluntarily terminate their CMS-approved home
infusion therapy accreditation program is likely make this decision at
least 6 months prior to the date that they would completely cease
operations, in order to give them time to wrap up their business
affairs and wind down operations. For example, the AO would need to
complete any surveys that had been scheduled or refer these clients to
other AOs. They would also need to provide notice to their accredited
home infusion therapy suppliers of their decision to voluntarily
terminate their CMS-approved home infusion therapy accreditation
program.
We agree with these commenters that the 90 day notice period may
not be a sufficient period of time in which an otherwise compliant home
infusion therapy provider could seek out another CMS-approved home
infusion therapy AO, file the required application, and complete the
accreditation process. Therefore, we have decided to increase the
notice requirement specified in Sec. 488.1010(a)(23)(i) from 90 days
to 180 days as requested.
It is important to note that Sec. 488.1010(a)(23) requires the
home infusion therapy AOs to provide a written statement in their
application to CMS, in which the home infusion therapy AO acknowledges,
as a condition for approval, that the organization agrees to the items
set forth in Sec. 488.1010(a)(23)(i) through (vi). However, the actual
requirement that the home infusion therapy AO provide notice is set
forth at Sec. 488.1045(a). Since we will be increasing the notice
requirement that is to be included in the statement that is to be
provided in the application submitted by the home infusion therapy AO
as a condition for approval as required by Sec. 488.1010(a)(23)(i), we
must also make a corresponding change to the notice requirement in
Sec. 488.1045(a).
Final Decision: Section 488.1010(23)(a)(i) will be amended by
changing the notice requirement for home infusion therapy AOs that
voluntarily terminate their CMS-approved accreditation program from 90
days to 180 days. This change requires that we also make a
corresponding
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change to the notice requirement of Sec. 488.1045(a). (See the
discussion of Sec. 488.1045(a) in this final rule with comment period)
for this corresponding change.
(4) Resubmitting a Request (Sec. 488.1015)
Proposed Sec. 488.1015(a) requires that except as provided in
paragraph (b), a home infusion therapy AO whose request for CMS'
approval or re-approval of a home infusion therapy accreditation
program was denied, or an organization that has voluntarily withdrawn
an initial application, could resubmit its application if the
organization had: (1) Revised its accreditation program to address the
issues related to the denial of its previous request or its voluntary
withdrawal; and (2) resubmitted the application in its entirety.
Proposed Sec. 488.1015(b) provides that a home infusion therapy AO
that has requested reconsideration of an application denial by CMS
could not submit a new application until the pending reconsideration
was administratively final. This proposed provision would ensure that
review of accreditation matters on reconsideration are pending before
only one administrative agency and one administrative level at a time.
We sought public comments on the requirements of Sec. 488.1015. We
did not receive any comments regarding Sec. 488.1015.
Final Decision: Having received no comments in regards to Sec.
488.1015, this section will be finalized as drafted, without
modification.
(5) Public Notice and Comment (Sec. 488.1020)
Proposed Sec. 488.1020(a) requires CMS to publish a notice in the
Federal Register upon receipt of a complete application package. The
notice would identify the organization, the type of home infusion
therapy suppliers covered by the accreditation program, and provides
for at least a 30-day public comment period (which begins on the date
of publication of the Federal Register notice). The purpose of the
Federal Register notice is to notify the public that a national AO has
filed an application for approval of a home infusion therapy
accreditation program and to seek public comment in response to this
application. The requirement for the publication of a notice in the
Federal Register when an application is received is an existing
regulatory procedural requirement for all other AO types. We have added
this requirement to the home infusion therapy AO approval and oversight
regulations for consistency, and because we believe that it is
important for the public to have notice of accreditation organization
activities.
Section 488.1020(b) requires that when CMS approves or re-approves
an application for approval of a home infusion therapy AO's
accreditation program, a final notice will be published in the Federal
Register. This notice would have to specify the basis for CMS'
decision. Section 488.1020(b)(1), requires that our final notice
include at a minimum, the following information: (1) How the
accreditation program met or exceeded Medicare accreditation program
requirements; (2) the effective date of the CMS approval, which is not
later than the publication date of the notice; and (3) the term of the
approval (6 years or less).
If CMS makes a decision to disapprove a home infusion therapy AOs
application, our final notice would state the deficiencies found in the
application and the reason why the AOs accreditation program did not
met or exceeded Medicare accreditation program requirements. However,
an AO has the option of voluntarily withdrawing its application at any
time up until the publication of the final notice.
We proposed at Sec. 488.1020(b)(2) that if CMS did not approve a
home infusion therapy AO's application for approval of its home
infusion therapy accreditation program, the final notice would explain
how the home infusion therapy AO failed to meet Medicare home infusion
therapy accreditation program requirements. This notice would indicate
the effective date of the decision.
We sought comment on the requirements of Sec. 488.1020, including
on the appropriate term for approval of an AO. We did not receive any
comments regarding Sec. 488.1020.
Final Decision: Having received no comments in regards to Sec.
488.1020, this section will be finalized as drafted, without
modification.
(6) Release and Use of Accreditation Surveys (Sec. 488.1025)
Proposed Sec. 488.1025 requires a home infusion therapy AO to
include, in its accreditation agreement with each home infusion therapy
supplier, an acknowledgement that the home infusion therapy supplier
agrees to release to CMS a copy of its most current accreditation
survey and any information related to the survey that CMS may require,
including the home infusion therapy supplier's corrective action plans.
Proposed Sec. 488.1025(a) provides that CMS may determine that a home
infusion therapy supplier does not meet the applicable Medicare
conditions or requirements on the basis of its own investigation of the
accreditation survey or any other information related to the survey.
Proposed Sec. 488.1025(b) prohibits CMS from disclosing home
infusion therapy survey reports or survey related information according
to section 1865(b) of the Act. However, CMS would be permitted to
publicly disclose an accreditation survey and information related to
the survey, upon written request, to the extent that the accreditation
survey and survey information is related to an enforcement action taken
by CMS.
CMS would use the home infusion therapy supplier accreditation
survey information for purposes such as: (1) Confirmation of the home
infusion therapy supplier's eligibility for Medicare participation; (2)
to review and approve the home infusion therapy AO's recommendations
regarding accreditation; (3) to review the home infusion therapy AO's
investigations of complaints; and (4) to review the corrective action
taken by the AO when deficiencies are found on survey.
We sought public comments on the requirements of Sec. 488.1025. We
did not receive any comments regarding Sec. 488.1025.
Final Decision: Having received no comments in regards to Sec.
488.1025, this section will be finalized as drafted, without
modification.
(7) Ongoing Review of Accrediting Organizations (Sec. 488.1030)
Proposed Sec. 488.1030 clarifies that a formal accreditation
program review could be opened on an ongoing basis. Specifically, this
proposed section would describe standardized requirements related to
the ongoing federal review of home infusion therapy AOs and their
approved accreditation programs. This proposed section would clarify
that CMS oversight of accreditation programs is consistent across home
infusion therapy AOs. We are committed to treating all home infusion
therapy AOs subject to our oversight in the same manner. Under proposed
Sec. 488.1030, we could conduct the following three types of reviews
of an AO's home infusion therapy accreditation programs: (1)
Performance review; (2) comparability review; and (3) CMS-approved
accreditation program review.
Proposed Sec. 488.1030(a) allows CMS to perform a performance
review, in which we would evaluate the performance of each CMS-approved
home infusion
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therapy accreditation program on an ongoing basis. Specifically, we
would review the following aspects of a home infusion therapy AO's for
home infusion therapy program performance: The organization's survey
activity, and the organization's continued fulfillment of the
requirements stated in Sec. 488.1010.
Proposed Sec. 488.1030(b) allows CMS to perform a comparability
review to assess the equivalency of a home infusion therapy AO's CMS-
approved home infusion therapy accreditation program requirements with
comparable Medicare home infusion therapy accreditation requirements.
Proposed Sec. 488.1030(b)(1) allows CMS to perform a comparability
review when CMS imposes new or revised Medicare accreditation
requirements. When this occurs, proposed Sec. 488.1030(b)(1) requires
CMS to provide written notice to the home infusion therapy AOs when
changes have been made to the Medicare home infusion therapy
accreditation requirements. Proposed Sec. 488.1030(b)(2) requires the
home infusion therapy accrediting organization to make revision to its
home infusion therapy accreditation standards or survey process so as
to incorporate the new or revised Medicare accreditation requirements.
Proposed Sec. 488.1030(b)(3) would further require that the
written notice sent by CMS to the home infusion therapy AO specify a
deadline (not less than 30 days) by which the home infusion therapy AO
must prepare and submit their home infusion therapy accreditation
program requirement revisions and the timeframe for implementation.
Proposed Sec. 488.1030(b)(4) would allow a home infusion therapy AO to
submit a written request for an extension of the submission deadline as
long as this request was submitted prior to the original deadline.
Proposed at Sec. 488.1030(b)(5) requires that, after completing
the comparability review, CMS would provide written notification to the
home infusion therapy AO, specifying whether or not their revised home
infusion therapy accreditation program standards continued to meet or
exceed all applicable Medicare requirements. We propose at Sec.
488.1030(b)(6) that if, no later than 60 days after receipt of the home
infusion therapy AO's accreditation standard changes, CMS did not
provide the written notice to the home infusion therapy AO, then the
revised home infusion therapy program accreditation standards would be
deemed to meet or exceed all applicable Medicare requirement and the
accreditation program will have continued CMS-approval without further
review or consideration.
Proposed Sec. 488.1030(b)(7) provide that if a home infusion
therapy AO was required to submit a new application because CMS imposed
new regulations or made significant substantive revisions to the
existing regulations, CMS would provide notice of the decision to
approve or disapprove the application within the time period specified
in proposed Sec. 488.1010(d).
We proposed at Sec. 488.1030(b)(8) that if a home infusion therapy
AO failed to submit its changes within the required timeframe, or
failed to implement the changes that had been determined by CMS to be
comparable, CMS could open an accreditation program review in
accordance with Sec. 488.1030(d).
When a home infusion therapy AO proposes to adopt new home infusion
therapy accreditation standards or changes, in its survey process, we
proposed at Sec. 488.1030(c)(1) to require the home infusion therapy
AO to provide notice to CMS no less than 60 days prior to the planned
implementation date of the changes. Proposed Sec. 488.1030(c)(2)
prohibits the home infusion therapy AO from implementing these changes
before receiving CMS' approval except as provided in proposed Sec.
488.1030(c)(4). Proposed Sec. 488.1030(c)(3) requires that this
written notice contain a detailed description of the changes to be made
to the organization's home infusion therapy accreditation standards,
including a detailed crosswalk (in table format) that states the exact
language of the revised accreditation requirements and the
corresponding Medicare requirements for each. The requirements of
proposed Sec. Sec. 488.1030(c)(2) and 488.10(c)(3) ensures that the
home infusion therapy AO provides CMS with advance notice of any
changes to their home infusion therapy accreditation requirements and
survey processes. This notice would allow CMS time to review these
changes to ensure that the revised home infusion therapy accreditation
standards and survey processes continue to meet or exceed all
applicable Medicare home infusion therapy requirements and continue to
be comparable to all applicable Medicare home infusion therapy survey
processes, and provide a response to the home infusion therapy AO. This
proposed section would also prohibit home infusion therapy AOs from
implementing any of the changes in their home infusion therapy
accreditation requirements and survey processes, until CMS approval has
been received.
Proposed Sec. 488.1030(c)(4) requires CMS to provide written
notice to the home infusion therapy accrediting organization indicating
whether the home infusion therapy accreditation program, including the
revisions, continued or does not continue to meet or exceed all
applicable Medicare home infusion therapy requirements. If CMS found
that the accrediting organization's home infusion therapy accreditation
program, including the revisions did not continue to meet or exceed all
applicable Medicare home infusion therapy requirements. CMS would have
to state the reasons for these findings.
Section 488.1030(c)(5) requires CMS to provide this written notice
to the home infusion therapy AO by the 60th calendar day following
receipt of the home infusion therapy AO's written changes as to whether
the home infusion therapy AO's revised home infusion therapy
accreditation program standards and survey processes have been be
deemed to meet or exceed all applicable Medicare home infusion therapy
requirements and have continued CMS approval without further review or
consideration. This proposed section would further specify that if CMS
failed to provide the required written notice to the home infusion
therapy AO by the 60-day deadline, the home infusion therapy AO's
revised accreditation program standards would be deemed to meet or
exceed all applicable Medicare requirements and have continued CMS
approval without further review or consideration.
Proposed Sec. 488.1030(c)(5) permits CMS to open an accreditation
program review, in accordance with Sec. 488.1030(d), if a home
infusion therapy AO implemented changes to their home infusion therapy
accreditation requirements or survey process that were not determined
nor deemed by CMS to be comparable to the applicable Medicare
requirements.
We proposed at Sec. 488.1030(d) to permit CMS to initiate an
accreditation program review when a comparability or performance review
reveals evidence that a home infusion therapy AO's CMS-approved home
infusion therapy accreditation program is in substantial non-compliance
with the requirements of the home infusion therapy health and safety
regulations contained in 42 CFR part 486, subpart B. Proposed Sec.
488.1030(d)(1) requires CMS to provide written notice to the home
infusion therapy AO when a home infusion therapy accreditation program
review is initiated. Proposed Sec. 488.1030(d)(1)(i) through (iv) set
forth the requirements for this written notice,
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which should contain the following information: (i) A statement of the
instances, rates or patterns of non-compliance identified, as well as
other related information, if applicable; (ii) a description of the
process to be followed during the review, including a description of
the opportunities for the home infusion therapy AO to offer factual
information related to CMS' findings; (iii) a description of the
possible actions that may be imposed by CMS based on the findings of
the accreditation program review; and (iv) the actions the home
infusion therapy AO will have to take to address the identified
deficiencies, and the length of the accreditation program review
probation period, which would include monitoring of the home infusion
therapy AO's performance and implementation of the corrective action
plan. The probation period is not to exceed 180 calendar days from the
date that CMS has approved the home infusion therapy AOs plan of
correction (which is the AO written plan for correcting any
deficiencies in its home infusion therapy accreditation program that
were found by CMS on a program review).
At Sec. 488.1030(d)(2), we proposed that CMS reviews and approves
the home infusion therapy AO's plan of correction for acceptability
within 30 days after receipt. Proposed Sec. 488.1030(d)(3) provides
that CMS monitors the implementation of the home infusion therapy
accrediting organization's plan of correction for a period not to
exceed 180 days from the date of approval. During the 180-day review
period, CMS monitors implementation of the accepted plan of correction
as well as progress towards correction of identified issues and areas
of non-compliance that triggered the accreditation program review.
We proposed at Sec. 488.1030(d)(4) to authorize CMS to place the
home infusion therapy AO's CMS-approved accreditation program on
probation for a subsequent period of up to 180 calendar days, if
necessary. The additional period of time may be necessary if CMS
determines, as a result of the home infusion therapy accreditation
program review or a review of an application for renewal of an existing
CMS-approved accreditation program, that the home infusion therapy AO
has failed to meet any of the requirements of proposed Sec. 488.1010,
or has made significant progress correcting identified issues or areas
of non-compliance, but requires additional time to complete full
implementation of corrective actions or demonstrate sustained
compliance. If a home infusion therapy AO's term of approval expires
before the 180-day period is completed, the probationary period would
be deemed to end upon the day of expiration of the home infusion
therapy AO's term of approval. In the case of a renewal application
where we have placed the home infusion therapy accreditation program on
probation, we proposed that any approval of the applications must be
conditional while the program remains on probation.
If we place a home infusion therapy AO's accreditation program on
probation, proposed Sec. 488.1030(d)(4)(i) requires CMS to issue a
written determination to the home infusion therapy AO, within 60
calendar days after the end of any probationary period. The written
determination must state whether or not the CMS-approved home infusion
therapy accreditation program continued to meet the requirements of
this section and the reasons for the determination.
If we determined that withdrawal of approval from a CMS-approved
accreditation program was necessary, proposed Sec. 488.1030(d)(4)(ii)
requires CMS to send written notice to the home infusion therapy AO
which contained the following information: (1) Notice of CMS' removal
of approval of the home infusion therapy AOs accreditation program; (2)
the reason(s) for the removal; and (3) the effective date of the
removal determined in accordance with Sec. 488.1030(d)(4)(ii).
If CMS withdrew the approval of a home infusion therapy AO
accreditation program, Sec. 488.1030(d)(4)(iii) requires CMS to
publish a notice of its decision to withdraw approval of the
accreditation program in the Federal Register. This notice will have to
include the reasons for the withdrawal, and a notification that the
withdrawal will become effective 60 calendar days after the date of
publication in the Federal Register. The publication of this Federal
Register notice is notice will be necessary to put interested
stakeholders, such as the home infusion therapy suppliers that are
accredited by the affected AO on notice about the withdrawal of CMS-
approval of their AO, because this will have an effect on the status of
their accreditation.
Proposed Sec. 488.1030(e) allows CMS to immediately withdraw the
CMS approval of an home infusion therapy AO's home infusion therapy
accreditation program, if at any time CMS makes a determination that
the continued approval of that home infusion therapy accreditation
program poses an immediate jeopardy to the patients of the entities
accredited under the program; or the continued approval otherwise
constitutes a significant hazard to the public health.
We proposed at Sec. 488.1030(f) to mandate that any home infusion
therapy AO whose CMS approval of its home infusion therapy
accreditation program has been withdrawn must notify, in writing, each
of its accredited home infusion therapy suppliers of the withdrawal of
CMS approval and the implications for the home infusion therapy
suppliers' payment status no later than 30 calendar days after the
notice is published in the Federal Register. This proposed requirement
would protect the home infusion therapy suppliers that have received
their accreditation from a home infusion therapy AO that has had its
CMS approval of their home infusion therapy accreditation program
removed.
We sought public comments on the requirements and the burden
associated with the requirements of Sec. 488.1030.
We did not receive any comments related to the burden associated
with requirements Sec. 488.1030. However, we did receive the following
comment related to the requirements of Sec. 488.1030:
Comment: Several commenters have requested that CMS clarify that
the non-compliance that triggers a review under Sec. 488.1030 must not
only be ``substantial'' but also be ``material.''
Response: The term ``substantial'' means ``of considerable
importance, size or worth.'' The term ``material'' means ``important,
relevant or essential.'' \80\ We believe that these terms are similar
enough in nature that adding the word ``material'' would be
duplicative. Our goal, as stated in the proposed rule, is to make the
AO approval and oversight regulations as consistent, as possible, with
the AO approval and oversight regulations for Medicare-certified
providers and suppliers at 42 CFR 488.5 to 488.13. The term
``substantial and material'' is not used in regulation Sec. 488.8
titled ``Ongoing review of accrediting organizations.'' which is the
comparable regulation to Sec. 488.1030 regulations for Medicare-
certified providers and suppliers. Therefore, we believe that to add a
different standard for home infusion therapy AOs would be inconsistent
and would result in different standards across the AO types.
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\80\ Merriam Webster Online Dictionary.
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Also, many AOs have accreditation programs for numerous types of
providers and suppliers. If CMS were to use varying standards for
different types of providers and suppliers, it would make it difficult
for these AOs with multiple accreditation programs to administer these
programs in a smooth
[[Page 56576]]
and consistent manner. Therefore, we believe that it is important that
CMS keep the language of Sec. 488.1030 consistent with that of Sec.
488.8. We would also note that we have broad discretion to monitor the
performance of AOs and to take action when necessary.
Final Decision: After consideration on the comments received, we
have decided to finalize Sec. 488.1030 without modification.
(8) Ongoing Responsibilities of a CMS-Approved Accreditation
Organization (Sec. 488.1035)
Proposed Sec. 488.1035 requires a home infusion therapy AO to
provide certain information to CMS and carry out certain activities on
an ongoing basis. More specifically Sec. 488.1035(a) requires the home
infusion therapy AO to provide CMS with all of the following in written
format (either electronic or hard copy):
Copies of all home infusion therapy accreditation surveys,
together with any survey-related information that CMS may require
(including corrective action plans and summaries of findings with
respect to unmet CMS requirements);
Notice of all home infusion therapy accreditation
decisions.
Notice of all complaints related to home infusion therapy
suppliers.
Information about all home infusion therapy accredited
suppliers against which the home infusion therapy AO has taken remedial
or adverse action, including revocation, withdrawal, or revision of the
home infusion therapy supplier's accreditation.
Summary data specified by CMS that relate to the past
year's home infusion therapy accreditation activities and trends which
is to be provided on an annual basis.
Notice of any changes in its home infusion therapy
accreditation standards or requirements or survey process.
Proposed Sec. 488.1035(b) requires a home infusion therapy AO to
submit an acknowledgment of receipt of CMS' notification of a change in
CMS requirements within 30 days from the date of the notice. Section
488.1035(c) requires that a home infusion therapy AO permit its
surveyors to serve as witnesses if CMS takes an adverse action based on
accreditation findings.
Proposed Sec. 488.1035(d) requires that within 2 business days of
identifying a deficiency of an accredited home infusion therapy
supplier that poses immediate jeopardy to a beneficiary or to the
general public, the home infusion therapy AO must provide CMS with
written notice of the deficiency and any adverse action implemented by
the home infusion therapy AO. Section 488.1035(e) requires that within
10 calendar days after our notice to a CMS-approved home infusion
therapy AO that CMS intends to withdraw approval of the home infusion
therapy AO, the home infusion therapy AO must provide written notice of
the withdrawal to all of the organization's accredited home infusion
therapy suppliers.
We sought public comment on the requirements and the burden
associated with Sec. 488.1035. We received no comments in regards to
requirements and the burden associated with Sec. 488.1035.
Final Decision: As no comments related to Sec. 488.1035 were
received, this section to the proposed regulations will be finalized as
drafted and without modifications.
(9) Onsite Observations of Accrediting Organization Operations (Sec.
488.1040)
We proposed at Sec. 488.1040(a) and (b) to permit CMS to conduct
an onsite inspection of the home infusion therapy AOs operations and
offices at any time to verify the organization's representations and to
assess the organization's compliance with its own policies and
procedures. Activities to be performed by CMS staff during the onsite
inspections may include, but are not limited to: (1) Interviews with
various home infusion therapy AO staff; (2) review of documents, and
survey files, audit tools and related records; (3) observation of
meetings concerning the accreditation process; (4) auditing meetings
concerning the accreditation process; (5) observation of in-progress
surveys and audits; (6) evaluation of the home infusion therapy AO's
survey results and accreditation decision-making process.
CMS would perform onsite visits to a home infusion therapy AOs
offices only for specific reasons. For example, when an AO had filed an
initial or renewal application for approval of its home infusion
therapy accreditation program, CMS would perform an onsite visit to the
AOs offices as part of the application review process. If CMS has
opened a program review and put the home infusion therapy AO on
probation for a 180 day period, we would perform an onsite visit to the
AOs offices to check of the AOs progress in implementing the plan of
correction.
If CMS decides to perform on onsite visit to the home infusion
therapy AOs offices, we would notify the AO. We would coordinate with
the AO staff to schedule the onsite visit at mutually agreed upon date
and time.
The intended purpose of this proposed section is to provide CMS
with an opportunity to observe, first hand, the daily operations of
home infusion therapy AOs and to ensure that the home infusion therapy
accreditation program is fully implemented and operational as presented
in the written application. Onsite inspections would strengthen our
continuing oversight of the home infusion therapy AO performance
because they provide an opportunity for us to corroborate the verbal
and written information submitted to CMS by the home infusion therapy
AO in their initial and renewal applications. In addition, onsite
inspections would allow CMS to assess the home infusion therapy AO's
compliance with its own policies and procedures.
We sought public comments on the requirements of and the burden
related to Sec. 488.1040. However, we received no comments in regards
to requirements and the burden associated with Sec. 488.1040.
Final Decision: As no comments related to Sec. 488.1040 were
received, this section to the proposed regulations will be finalized as
drafted and without modifications.
(10) Voluntary and Involuntary Termination (Sec. 488.1045)
The proposed provisions related to the voluntary and involuntary
termination of CMS approval of a home infusion therapy AO's
accreditation program are set out at Sec. 488.1045. Proposed Sec.
488.1045(a) addresses voluntary termination of a home infusion therapy
AO's accreditation program by the home infusion therapy AO. A home
infusion therapy AO that decides to voluntarily terminate its CMS-
approved accreditation program must provide written notice to CMS and
each of its accredited home infusion therapy suppliers at least 180
days in advance of the effective date of the termination. This written
notice must state the implications for the home infusion therapy
supplier's payment should there be a lapse in their accreditation
status.
Proposed Sec. 488.1045(b) addresses CMS' involuntary termination
of a home infusion therapy AO's CMS-approved accreditation program.
Once CMS publishes the notice in the Federal Register announcing its
decision to terminate the accrediting organization's home infusion
therapy accreditation program, the home infusion therapy AO would have
to provide written notification to all home infusion therapy suppliers
accredited under its CMS-approved home infusion therapy accreditation
program no later than 30 calendar days after the notice was published
in the Federal Register. This
[[Page 56577]]
notice would state that CMS is withdrawing its approval of the home
infusion therapy AO's accreditation program and the implications for
their payment, should there be a lapse in their accreditation status.
Proposed Sec. 488.1045(c) addresses the requirements that would
apply to both voluntary and involuntary terminations of CMS approval of
the home infusion therapy AO. Proposed Sec. 488.1045(c)(1) provides
that the accreditation status of affected home infusion therapy
suppliers will be considered to remain in effect until their current
term of accreditation expired. In the case where a home infusion
therapy AO has been removed as a CMS-approved AO, any home infusion
therapy supplier that is accredited by the organization during the
period beginning on the date the organization was approved by CMS until
the date the organization was removed, shall be considered accredited
for its remaining accreditation period.
Proposed Sec. 488.1045(c)(2) provides that for any home infusion
therapy supplier, whose home infusion therapy AO's CMS approval has
been voluntarily or involuntarily terminated by CMS, and who wishes to
continue to receive reimbursement from Medicare, must provide written
notice to CMS at least 60-calendar days prior to its accreditation
expiration date which states that the home infusion therapy supplier
has submitted an application for accreditation under another CMS-
approved home infusion therapy accreditation program. This proposed
section further states that failure to comply with this 60-calendar day
requirement prior to expiration of their current accreditation status
could result in a suspension of payment.
Proposed Sec. 488.1045(c)(3) requires that the terminated home
infusion therapy AO must provide a second written notification to all
accredited suppliers 10 calendar days prior to the organization's
accreditation program effective date of termination.
The proposed notice provisions at Sec. 488.1045(c)(2) and (3)
could help prevent home infusion therapy suppliers from suffering
financial hardship that could result from a denial of payment of
Medicare claims if their home infusion therapy accreditation lapses as
a result of the voluntary or involuntary termination of a CMS-approved
home infusion therapy AO program.
We proposed at Sec. 488.1045(d), that if a home infusion therapy
supplier requests a voluntary withdrawal from accreditation, it will
not be possible for the withdrawal to become effective until the home
infusion therapy AO completes three required steps. First, the AO would
have to contact the home infusion therapy supplier to seek written
confirmation that the home infusion therapy supplier intended to
voluntarily withdraw from the accreditation program. Second, the home
infusion therapy AO would have to advise home infusion therapy
supplier, in writing, of the statutory requirement at section
1861(iii)(3)(D)(i)(III) of the Act for requiring accreditation for all
home infusion therapy suppliers. Third, the home infusion therapy AO
would have to advise the home infusion therapy supplier of the possible
payment consequence for a lapse in accreditation status. Section
488.1045(d)(3) requires the home infusion therapy AO to submit their
final notice of the voluntary withdrawal of accreditation by the home
infusion therapy supplier 5 business days after the request for
voluntary withdrawal was ultimately processed and effective.
We believe that it is important that the home infusion therapy seek
confirmation that the home infusion therapy supplier has indeed
requested a voluntary termination of their accreditation. This
confirmation would prevent the erroneous termination of the
accreditation of a home infusion therapy supplier that did not request
it or had subsequently withdrawn their request for voluntary
termination.
We believe that it is also important for the home infusion therapy
AO to provide the required written notice to the home infusion therapy
supplier that requests a voluntary withdrawal from accreditation, so
that the home infusion therapy supplier has been fully informed of the
requirements for accreditation according to section
1861(iii)(3)(D)(i)(III) of the Act and the payment consequences of
being unaccredited. If there is a lapse in the accreditation status of
the home infusion therapy supplier, they would not be eligible to
receive payment from Medicare for services furnished to Medicare
beneficiaries. A home infusion therapy infusion therapy supplier that
is unaware of this payment consequence could suffer financial hardship
due to furnishing services to Medicare beneficiaries for which they
cannot be reimbursed after a lapse in accreditation.
We solicited public comments on the requirements of and the burden
related to Sec. 488.1045.
Comment: A commenter expressed concern that the requirements of
proposed Sec. 488.1045(d) would be extremely burdensome for the home
infusion therapy AO to implement. This section provides that if a home
infusion therapy supplier requested a voluntary withdrawal from
accreditation, it would not be possible for the withdrawal to become
effective until the home infusion therapy AO completed the following
three required steps: (1) The AO must contact the home infusion therapy
supplier to seek written confirmation that the home infusion therapy
supplier intended to voluntarily withdraw from the accreditation
program; (2) the home infusion therapy AO must to advise home infusion
therapy supplier, in writing, of the statutory requirement at
1861(iii)(3)(D)(i)(III) of the Act for requiring accreditation for all
home infusion therapy suppliers; and (3) the home infusion therapy AO
must advise the home infusion therapy supplier of the possible payment
consequence for a lapse in accreditation status. Proposed Sec.
488.1045(d)(3) would require the home infusion therapy AO to submit
their final notice of the voluntary withdrawal of accreditation by the
home infusion therapy supplier 5 business days after the request for
voluntary withdrawal was ultimately processed and effective.
In support of this contention that the previous requirements would
be too burdensome, the commenter stated the belief that the home
infusion therapy supplier would be responsible for knowing the CMS
rules of coverage. AO's should provide this information to the supplier
in the form of the AO's accreditation process and/or procedures. The AO
should not have the burden of producing documentation that they
informed the supplier at 3 separate times of what could happen if they
withdrew their accreditation.
Response: We disagree with this commenter's contention that the
requirements of proposed Sec. 488.1045(d) are burdensome for the home
infusion therapy AO to implement with the business technology that is
readily available to each AO. It is important to point out that all 3
of these previously discussed steps can be accomplished quickly and
effectively and would take a relatively short period of time. We say
this because this section merely requires that each of the 3 categories
of information is obtained and disseminated to the home infusion
therapy supplier. This section does not require them to be accomplished
separately at different times or on different dates.
Similarly, we believe that this task can be accomplished by the AO
sending one single correspondence to the home infusion therapy supplier
and simple follow-up monitoring to ensure that the
[[Page 56578]]
home infusion therapy supplier returns the required written
confirmation to the AO acknowledging that they do intend to voluntarily
withdraw from the accreditation program. To simplify matters further
and save even more time, we believe that the AO could create a pre-
prepared home infusion therapy supplier notification letter and an
acknowledgment of withdrawal from accreditation form in a fillable .pdf
template format. Thereafter, when a home infusion therapy supplier
notifies an AO that they are withdrawing from that AO, all the AO would
need to do is open up the AO notification and home infusion therapy
supplier acknowledgement templates on their computer, fill in the
blanks on the fillable .pdf template forms, print the forms and send
them HIT supplier via hand deliver, text, email, fax or U.S.P., federal
Express, etc. Then AO would only have to await for the HIT supplier to
return the signed acknowledgement form.
Comment: Sec. 488.1045(c)(2) provides that if a home infusion
therapy supplier, whose home infusion therapy AO's CMS approval has
been voluntarily or involuntarily terminated by CMS wishes to continue
to receive reimbursement from Medicare, that home infusion therapy
supplier must provide written notice to CMS at least 60-calendar days
prior to its accreditation expiration date which states that the home
infusion therapy supplier has submitted an application for
accreditation under another CMS-approved home infusion therapy
accreditation program. This proposed section further states that
failure to comply with this 60-calendar day requirement prior to
expiration of their current accreditation status could result in a
suspension of payment.
Several commenters have urged CMS to amend the notice requirement
of proposed Sec. 488.1045(c)(2). These commenters have requested that
CMS decrease the minimum time period by which affected home infusion
therapy suppliers must provide their written notice to CMS informing us
that they have filed an application with another home infusion therapy
AO from 60 days to 5 days prior to the effective date of the
termination of the home infusion therapy suppliers current term of
accreditation. These commenters stated the belief that the change to a
5 day notice requirement will ensure that the second AO termination
notice to providers can be acted upon if, for any reason, the original
termination notice was missed.
Response: We understand the concern on the part of home infusion
therapy suppliers about possibly missing the first notice sent by their
home infusion therapy AO when that AOs CMS-approval has been
voluntarily or involuntarily withdrawn. We believe that in the event a
home infusion therapy AO voluntarily or voluntarily has its CMS-
approval terminated, there will be ample notice provided.
In the case of an involuntary termination of an AOs CMS approval,
Sec. 488.1045(b) as finalized requires that CMS publish a notice in
the Federal Register announcing its decision to terminate the
accrediting organization's home infusion therapy accreditation program,
therefore, the home infusion therapy AO will have to provide written
notification to all home infusion therapy suppliers accredited under
its CMS-approved home infusion therapy accreditation program no later
than 30 calendar days after the notice is published in the Federal
Register. This notice must state that CMS is withdrawing its approval
of the home infusion therapy AO's accreditation program, and also
discuss the implications for the supplier's payment, should there be a
lapse in their accreditation status. In the case of a voluntary
termination of an AO's CMS approval, proposed Sec. 488.1045(d)
provides that it will not be possible for the withdrawal to become
effective until the home infusion therapy AO completes three required
steps: (1) The AO must contact the home infusion therapy supplier to
seek written confirmation that the home infusion therapy supplier
intends to voluntarily withdraw from the accreditation program; (2) the
home infusion therapy AO must advise home infusion therapy supplier, in
writing, of the statutory requirement at section
1861(iii)(3)(D)(i)(III) of the Act for requiring accreditation for all
home infusion therapy suppliers; and (3) the home infusion therapy AO
must advise the home infusion therapy supplier of the possible payment
consequence for a lapse in accreditation status. Furthermore, Sec.
488.1045(d)(3) requires the home infusion therapy AO to submit a final
notice of the voluntary withdrawal of accreditation by the home
infusion therapy supplier 5 business days after the request for
voluntary withdrawal is ultimately processed and effective.
In addition to the notices required by the regulatory provisions
previously referenced, CMS will take all appropriate steps to ensure
that the affected home infusion therapy suppliers are given timely
notice about the termination of their home infusion therapy AO's CMS-
approved home infusion therapy accreditation program. Some possible
methods CMS would use to make this information available to these
affected home infusion therapy suppliers include, but are not limited
to posting of information on the Quality, Safety and Oversight Group
(QSOG) web page, notification sent via email and email blasts,
information published in the Medicare Learning Network newsletter,
Medicare payment manual bulletin, newsletter and in Medicare Learning
Network publications, and discussion during Open Door Forums.
We believe that the requirement that affected home infusion therapy
suppliers provide CMS with written notice that they have filed an
application for accreditation with another CMS-approved home infusion
therapy AO at least 60 days prior to the expiration of their current
term of accreditation is an essential requirement for several reasons.
First, it ensures CMS that all home infusion therapy suppliers affected
by a voluntary or involuntary termination of a particular AO's CMS-
approved accreditation program have indeed filed applications with
other CMS-approved home infusion therapy AOs in a timely manner.
Second, the required 60 day written notice to be provided by these
affected home infusion therapy suppliers informs CMS that they have
already filed an application and initiated the accreditation process
with another CMS-approved home infusion therapy AO. This in turn, will
trigger the CMS payment system not to continuing paying these home
infusion therapy suppliers until their new accreditation information is
received.
The requirement that written notice be submitted by all affected
home infusion therapy suppliers at least 60 days prior to the
expiration of their current terms of accreditation provides CMS with
assurances that the accreditation process for each these affected home
infusion therapy suppliers has already been initiated, is either
substantially completed or will be completed prior to the expiration of
the affected home infusion therapy suppliers current term of
accreditation and that CMS can be assured that they are not going to be
paying claims submitted by non-accredited home infusion therapy
supplier.
The accreditation process takes several months, at a minimum. If
CMS were to allow these home infusion therapy suppliers to wait until 5
days prior to the expiration date of their current term of
accreditation to notify CMS that they have initiated the accreditation
process (filed an application) with another AO, CMS would have no
assurance that the
[[Page 56579]]
accreditation process will be completed or substantially completed by
the time their current term of accreditation lapses. If this were the
case, CMS would not be able to prevent a lapse in payment to these home
infusion therapy suppliers that find themselves in the situation in
which the CMS-approval of their AO has been withdrawn. Therefore, this
requirement is intended to protect those otherwise compliant home
infusion therapy suppliers, who find themselves, through no fault of
their own, in the situation in which their current AO is no longer CMS-
approved.
Final Decision: After consideration of the comments received, we
have decided not to change the notification requirement set forth in
Sec. 488.1045(c)(2). Therefore, we are finalizing the provisions of
section Sec. 488.1045 without modification.
(11) Reconsideration (Sec. 488.1050)
We proposed at Sec. 488.1050 to set forth the appeal process
through which a home infusion therapy AO may request reconsideration of
an unfavorable decision made by CMS. Proposed at Sec. 488.1050(b)(1),
the home infusion therapy AO will have to submit a written request for
reconsideration within 30 calendar days of the receipt of the CMS
notification of an adverse determination or non-renewal. Proposed Sec.
488.1050(b)(2) requires the home infusion therapy AOs to submit a
written request for reconsideration which specifies the findings or
issues with which the home infusion therapy AO disagreed and the
reasons for the disagreement. Proposed Sec. 488.1050(b)(3) allows a
home infusion therapy AO to withdraw their request for reconsideration
at any time before the administrative law judge issues a decision.
We proposed at Sec. 488.1050(c)(1) to establish requirements for
CMS when a request for reconsideration has been received from a home
infusion therapy AO. Specifically, CMS would be required to provide the
home infusion therapy AO with: The opportunity for an administrative
hearing with a hearing officer appointed by the Administrator of CMS;
the opportunity to present, in writing and in person, evidence or
documentation to refute CMS' notice of denial, termination of approval,
or non-renewal of CMS approval and designation. Proposed Sec.
488.1050(c)(2) requires CMS to send the home infusion therapy AO
written notice of the time and place of the informal hearing at least
10 business days before the scheduled hearing date.
We proposed at Sec. 488.1050(d)(1) to establish rules for the
administrative hearing such as who may attend the hearing on behalf of
each party, including but not limited to legal counsel, technical
advisors, and non-technical witnesses that have personal knowledge of
the facts of the case. This proposed section would also specify the
type of evidence that may be introduced at the hearing. Specifically,
we would specify and clarify, at proposed Sec. 488.1050(d)(4), that
the hearing officer would not have the authority to compel by subpoena
the production of witnesses, papers, or other evidence. Proposed Sec.
488.1050(d)(5) provides that the legal conclusions of the hearing
officer within 45 calendar days after the close of the hearing.
Proposed Sec. 488.1050(d)(6) requires the hearing officer to present
his or her findings and recommendations in a written report that
includes separately numbered findings of fact. According to proposed
Sec. 488.1050(d)(7), the decision of the hearing officer would be
final.
We sought public comments on the requirements of Sec. 488.1050. We
received no comments on the requirements of Sec. 488.1050.
Final Decision: Having received no comments in regards to Sec.
488.1050, we are finalizing this provision without modification.
D. Payment for Home Infusion Therapy Services
1. Temporary Transitional Payment for Home Infusion Therapy Services
for CYs 2019 and 2020
In the CY 2019 HH PPS proposed rule (83 FR 32340) we discussed the
implementation of the home infusion therapy services temporary
transitional payment under paragraph (7) of section 1834(u) of the Act,
as added by section 50401 of the BBA of 2018 (Pub. L. 115-123). This
section provided for a temporary transitional payment for
administration of home infusion drugs for 2019 and 2020. These services
must be furnished by an eligible home infusion supplier in the
individual's home to an individual who is under the care of an
applicable provider 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. Section 1834(u)(7)(F) of the Act
defines eligible home infusion suppliers as suppliers that are enrolled
in Medicare as pharmacies that furnish external infusion pumps and
external infusion pump supplies, and that maintain all pharmacy
licensure requirements in the State in which the applicable infusion
drugs are administered. This means that existing DME suppliers that are
enrolled in Medicare as pharmacies that provide external infusion pumps
and supplies are considered eligible home infusion suppliers. 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 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. Additionally, section 1834(u)(7)(C) of the
Act specifies the HCPCS codes for the drugs and biologicals covered
under the Local Coverage Determinations (LCDs) for External Infusion
Pumps, and identifies three payment categories for which a single
payment amount will be established for home infusion therapy services
furnished on each infusion drug administration calendar day. Payment
category 1 includes antifungals and antivirals, uninterrupted long-term
infusions, pain management, inotropic, and chelation drugs. Payment
category 2 includes subcutaneous immunotherapy infusions. Payment
category 3 includes certain chemotherapy drugs. The payment category
for subsequent transitional home infusion drug additions to the LCDs
and compounded infusion drugs not otherwise classified, as identified
by HCPCS codes J7799 and J7999, will be determined by the Medicare
administrative contractors.
As set out at new section 1834(u)(7)(D) of the Act, each payment
category will be paid amounts equal to amounts for statutorily
specified codes for which payment is made under the Physician Fee
Schedule for each infusion drug administration calendar day in the
individual's home for drugs assigned to such category. No geographic
adjustment applies to the payments. In accordance with section
1834(u)(7)(E)(ii) of the Act, 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 would be made.
In the CY 2019 HH PPS proposed rule, we outlined the billing
procedure for the temporary transitional payment. We created a new
HCPCS G-code for each of the three payment categories. We stated that
the eligible home infusion supplier will submit, in line-item detail on
the claim, a G-code for each infusion drug administration
[[Page 56580]]
calendar day, which would include the length of time for which
professional services were furnished (in 15 minute increments). These
G-codes can be billed separately from or on the same claim as the DME,
supplies, and infusion drug. However, under the temporary transitional
payment period, the eligible home infusion supplier is required to be
enrolled as a pharmacy that provides external infusion pumps and
external infusion pump supplies and maintains all pharmacy licensure
requirements. Therefore, during this period, it is likely that the G-
codes will be billed on the same claim as the equipment, supplies, and
drug. However, for the full implementation of the benefit in 2021,
there may be two different suppliers: One furnishing the home infusion
therapy services in the home and one furnishing the DME, supplies, and
drug. The claims for the temporary transitional payment will be
processed through the DME MACs. In order to implement the requirements
of section 1834(u)(7) of the Act for this temporary transitional
payment, we will issue a Change Request (CR) prior to implementation of
this temporary transitional payment, including the G-codes needed for
billing, outlining the requirements for the claims processing changes
needed to implement this payment.
In general, section 1834(u)(7) specifies, in detail, the
requirements of the temporary transitional payment for home infusion
therapy services, and in most instances, we generally do not have the
discretion to apply different policies. However, we proposed a
regulatory definition of ``infusion drug administration calendar day''
to specify in more detail, the policy in the statute as to when
Medicare should make a single payment for home infusion therapy
services. As required by section 1834(u)(1)(A)(ii) of the Act, a unit
of single payment under the home infusion therapy benefit payment
system is for each infusion drug administration calendar day in the
individual's home. Section 1834(u)(7)(E)(i) clarifies that 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)) were furnished to administer such drugs to
such individual. Therefore, we proposed to define in regulation that
``infusion drug administration calendar day'' refers to payment for 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. As we stated in the proposed rule, we believe this to
mean skilled services as set out at 42 CFR. 409.32. This regulation
states that the skilled services furnished on such day must be so
inherently complex that they can only be safely and effectively
furnished by, or under the supervision of, professional or technical
personnel.
The following is a summary of the public comments received on the
``Proposed Temporary Transitional Payment for Home Infusion Therapy
Services for CYs 2019 and 2020'' and our responses.
Comment: Several commenters supported the proposed definition of
``infusion drug administration calendar day'' and noted that the home
infusion payment rates for 2019 and 2020 specified in the statute are
generally comparable and, in some cases, higher than the payment rates
for an in-home visit under the home health prospective payment system.
MedPAC agreed with CMS' requirement that home infusion therapy
providers report the length of home visits on their claims submissions,
as it would allow the agency to consider this data as it establishes
the payment rates for 2021, and could help to inform the agency's
consideration of potential payment adjustments based on patient acuity
or drug administration complexity.
Response: We thank the commenters for their review and support of
both the temporary and permanent payment structures for home infusion
therapy services. We agree that the data obtained by requiring the
length of the visit on the claim will be helpful in establishing
payment adjustments for the full implementation of the benefit in 2021.
Comment: In general, other commenters stated that the definition of
``infusion drug administration calendar day'', and the resulting
payment limitation based on physical presence would be contrary to law
and Congressional intent, and would inappropriately limit the number of
days of payment for home infusion therapy professional services.
Commenters expressed concern that tying payment to days for which a
nurse provides in-person professional services, would limit payment
only to a small subset of the many professional services furnished in
connection with home infusion. Commenters stated that CMS should define
infusion drug administration calendar day to include a broader set of
professional services such as drug preparation, including sterile
compounding; clinical care planning; care coordination; and other
professional services that most often occur outside of the patient's
home and remove the physical requirement that a nurse be in the home
for payment to occur. Commenters also disagreed with the reference to
the definition of ``skilled services'' as set out at Sec. 409.32.
Commenters stated that it seems inappropriate to define home infusion
therapy professional services as skilled services in a skilled nursing
facility (SNF).
Response: We agree that there are a variety of providers and
professional services involved in home infusion therapy and recognize
their significance in ensuring that therapy is safe and effective in
the home.
However, in accordance with section 1861(iii)(1) of the Act, the
term ``home infusion therapy'' means the items and services furnished
by a qualified home infusion therapy supplier, which are furnished in
the individual's home. Likewise, section 1834(u)(7)(B)(iv) establishes
a single payment amount for each infusion drug administration calendar
day 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) of the Act, were furnished to administer such
drugs to such individual. This includes all such drugs administered to
such individual on such day. We believe the BBA of 2018 includes this
clarification of ``infusion drug administration calendar day'' in order
to establish clear parameters so as to explicitly pay for services that
occur in the patient's home when the drug is being administered. Our
interpretation of the phrase ``only for the date on which professional
services, as described in section 1861(iii)(2) of the Act, were
furnished'' is that mere infusion without any professional services
furnished cannot trigger a home infusion therapy services payment for
any day the drug is infused by the DME pump. Thus, we believe that the
language in the statute clearly delineates a subset of days on which
professional services are provided in the patient's home in order for
payment to occur.
Additionally, section 1834(u)(7)(A)(i) of the Act states that
payment to an eligible home infusion supplier is for items and services
furnished in coordination with the furnishing of transitional home
infusion drugs. The language does not indicate that payment is for the
furnishing of the home infusion drug, but for the services provided
together and in cooperation
[[Page 56581]]
with the furnishing of the drug. The Medicare payment for the drug is
made separately from home infusion therapy services. The statute also
states that payment is for the professional services furnished ``to
administer'' such drugs to such individual. As the term
``administered'' refers only to the physical process by which the drug
enters the patient's body,\81\ then the professional must be in the
patient's home furnishing services specifically related to this
process. We noted in the CY 2019 HH PPS proposed rule that we
understand that there may be professional services furnished in the
patient's home that do not occur on a day the drug is being
administered (83 FR 32464). However, we note that the home infusion
therapy services temporary transitional payment is a unit of single
payment, meaning all home infusion therapy services furnished, which
include professional services, training and education, remote
monitoring and monitoring, are built into the payment for the day the
professional services are furnished in the home and the drug is being
administered. With the addition of the home infusion therapy services
temporary transitional payment, suppliers will still receive payments
for furnishing the equipment, the supplies, and the drug (technically
considered a supply) under the DME benefit; but will also receive a
separate payment when professional services are furnished in the
patient's home under the home infusion therapy benefit.
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\81\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
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Furthermore, we note that the payment for an infusion drug
administration calendar day is a single payment amount covering:
professional services, including nursing services, furnished in
accordance with a plan of care; training and education (not otherwise
paid for as durable medical equipment); remote monitoring; and
monitoring services furnished by a qualified home infusion therapy
supplier. Therefore, at Sec. 486.525, we have mirrored the language in
section 1861(iii)(2)(A) of the Act that requires the provision of
professional services, including nursing services, furnished by the
home infusion therapy supplier in accordance with the plan of care.
Since the Medicare payment is a single payment amount, we do not
believe it is necessary to define ``professional services'' in
regulation. By specifically enumerating a specific list of services we
would risk inadvertently excluding services that may be necessary for
the care of a specific patient as part of the required services under
the home infusion therapy benefit.
Section 1861(iii)(1)(B) requires the individual to be under a plan
of care, established by a physician, prescribing the type, amount, and
duration of home infusion therapy services that are to be furnished.
Thus, it is the individual's physician who is responsible for
establishing the type and scope of professional services needed in the
home in order to ensure home infusion therapy is successful. In the
proposed rule, we did state that the services on this day must meet the
criteria for skilled services as set out at Sec. 409.32. This criteria
states that to be considered a skilled service, the service must be so
inherently complex that it can be safely and effectively performed only
by, or under the supervision of, professional or technical personnel.
Although this is a requirement for coverage of post-hospital SNF care,
the definition of skilled services is not specific to skilled nursing
services in a SNF. Section 409.42(c)(1) under the home health benefit
also references Sec. 409.32 as the criteria for intermittent skilled
nursing services. Additionally, although both benefits require
``skilled services'' in reference to nursing, the definition is not
exclusive to nursing services.
Finally, section 1834(u)(7)(D) of the Act sets the temporary
transitional payment equal to 4 units at the amounts determined under
the physician fee schedule (that is, equivalent to 4 hours of infusion
in a physician's office). Payment for an infusion drug administered in
a physician's office or outpatient center is made based on the
occurrence of the professional services furnished during the visit. The
professional services necessary for the infusion drug administration at
these sites of care are factored into the payment for the visit, not
separately payable. As such, it is not necessary to define the
professional services required for infusion drug administration in a
physician's office or outpatient center because payment is not
dependent upon the individual services furnished, but rather the
occurrence of the visit and the professional services furnished at the
time. Likewise, the home infusion therapy services temporary
transitional payment includes payment for any professional services
furnished in the patient's home to administer the infusion drug.
Comment: A commenter recommended CMS add additional payment for
visits exceeding a median visit time period such as 2 or 3 hours, as
initial visits in particular can vary from 1 to 6 hours. The commenter
stated that in the absence of these additional payments, home infusion
suppliers may limit the types of patients they accept during the
transitional period.
Response: Section 1834(u)(7)(D) of the Act sets the temporary
transitional payment equal to 4 units at the amounts determined under
the physician fee schedule (that is, equivalent to 4 hours of infusion
in a physician's office). Although we do recognize that there may be
some visits that exceed the number of units allowed, some visits may
also be shorter. The temporary transitional payment is statutorily
limited to the payment methodology as put forth in section
1834(u)(7)(D) of the Act.
Comment: Another commenter stated that many chronically ill
patients depend on home health agencies for home infusion therapy
services and supplies, and stated that home health agencies should
continue to be paid as they currently are for home infusion. Another
commenter stated that many home infusion suppliers do not actually
provide the necessary skilled nursing support and must contract with
home health agencies, which in turn, requires the home infusion company
to assume responsibility for visits which may be unrelated to the
patient's infusion therapy.
Response: It is important to emphasize that the home infusion
therapy services temporary transitional payment is separate from the
home health benefit. Home infusion therapy is excluded from the
Medicare home health benefit, and separately payable, beginning January
1, 2019. Section 1842(u)(7)(F) of the Act requires eligible home
infusion suppliers to be Medicare DME suppliers that are enrolled as
pharmacies that supply external infusion pumps and supplies in order to
receive the home infusion therapy services temporary transitional
payment. Not until the full implementation of the benefit in 2021 will
home health agencies have the option of becoming home infusion therapy
suppliers.
It is unclear why the commenter states that the home infusion
supplier would be required to assume responsibility for visits which
may be unrelated to the patient's infusion therapy. We recognize that
currently home infusion suppliers may contract with HHAs to furnish the
nursing services; however, it is incumbent upon the home infusion
supplier to negotiate appropriate contract terms in order to only
assume responsibility for services related to home infusion therapy.
We also note that section VI.C.2.f. of the proposed rule discusses
the
[[Page 56582]]
potential relationship/interaction between the home infusion therapy
benefit and home health benefit. We stated that although the patient is
not required to be homebound in order to receive home infusion therapy
services, we anticipate that there may be circumstances when a patient
may utilize both the home health benefit and the home infusion therapy
benefit concurrently. We will provide further discussion on this
relationship, including how we anticipate HHAs that furnish both home
health and home infusion therapy services would submit claims for each
of these services, in future rulemaking.
Comment: A few commenters expressed support for the inclusion of
requirements for remote monitoring in the home infusion benefit, and
encouraged CMS to consider how to incorporate the use of telehealth
into the final home infusion payment system. A commenter suggested that
CMS include requirements that monitoring be performed using medical
devices cleared by the FDA for remote monitoring purposes.
Response: As we do not have specific policies surrounding the
technology used in remote monitoring, for now we choose not to be
prescriptive regarding how remote monitoring, or which remote
monitoring devices, are used in home infusion. Anecdotally, we have
heard from many home infusion providers that monitoring in home
infusion consists mainly of phone calls. Likewise, the consensus from
TEP members was that physical assessment and in-person monitoring is
more common in home infusion due to the importance of visualizing the
access site.
Comment: Many commenters stated that the proposed definition of
infusion drug administration calendar day assumes that a nurse would be
present for each administration of the home infusion drug. Several
comments stated that requiring a nurse to come for every infusion day
was inefficient, unnecessary, and would put a tremendous financial
burden on patients who could not afford to have a nurse come every day
to administer the drug. Several commenters stated concern regarding the
potential inability to receive their infusion drugs on those days in
which a skilled professional is not present in the home during the
administration of the infusion drug. Some commenters stated that this
requirement would also cause an access issue for home infusion
patients, possibly resulting in an increase in deaths among those who
receive home infusion drugs, though no specific reason was provided as
to why this would be the case. Another commenter stated that infusion
suppliers would be forced to cut back on services, especially in rural
areas, due to a limited supply of nurses. Additionally, this commenter
stated that agencies will have to determine whether financially they
are able to cover non-reimbursed costs associated with the benefit for
Medicare patients, given that other payers do not require nurses to be
present when drugs are infused in a patient's home.
Response: We wish to remind stakeholders that the provision of home
infusion is not contingent upon a nurse being present each and every
day a drug is being infused, nor that a nurse is present during the
entire administration of the drug. An important goal of home infusion
therapy services is to teach patients to safely, effectively, and
independently self-administer the drug in the home. The home infusion
therapy services paid under this benefit furnished in the patient's
home help ensure that patients and/or their caregivers can reach this
goal. The requirement that a skilled professional be in the home on a
day an infusion drug is administered is only for purposes of
determining the days for which the bundled payment for home infusion
therapy services is made. We also note that there is no limit on the
number of times that a home infusion therapy services payment would be
made if a nurse needed to visit the beneficiary's home more than once a
week.
The payment for professional services and training and education
(not otherwise paid for under the Medicare Part B DME benefit), remote
monitoring and monitoring services is only made when a skilled
professional is physically present in a patient's home on a day of drug
administration. This does not mean that that the external infusion
pump, drug, and related supplies are not covered on days when there is
not a skilled professional in the home. The home infusion therapy
services temporary transitional payment is a separately paid amount
from the external infusion pump, drug, and related supplies.
Additionally, we state in the proposed rule that the professional
services covered under this benefit are not intended to provide on-
going nursing supervision throughout each infusion. We do not expect a
nurse to be present for every infusion, or to stay for the duration of
each infusion once the patient and/or caregiver has been taught to
operate the pump. In section VI.C.2.d. of the proposed rule, we outline
the training and education services that we believe the home infusion
therapy payment would cover. We state that these would include a
limited amount of teaching and training on the provision of home
infusion drugs that is not already covered under the DME benefit.
Furthermore, section 1861(iii)(2)(B) includes the provision of
monitoring and remote monitoring as part of the home infusion therapy
benefit. In the proposed rule, we indicated that we understand that
some home infusion therapy patients may require daily monitoring, but
generally do not need to be seen by a practitioner daily. In section
VI.C.2.d. of the proposed rule, we state our belief that monitoring and
remote monitoring can enable daily contact with, or assessment of
certain patients without necessitating a visit.
Considering that we do not expect a visit to be made for each
infusion drug administration, we also do not believe the supplier
should be paid every day that the medication is infused regardless of
whether or not direct care services are furnished. We should also
emphasize that the patient is responsible for 20 percent coinsurance
for every home infusion therapy services payment in addition to the 20
percent coinsurance charged for the DME infusion pump supplies and the
drug. Therefore, we believe tying the payment to a visit in the
beneficiary's home would ensure that the beneficiary is receiving
direct care services for which he/she is paying 20 percent coinsurance.
We state in the proposed rule that we generally anticipate that a home
infusion therapy supplier would provide a visit approximately two times
a week for the first week and then weekly thereafter over the course of
infusion therapy depending on the drug and patient. Therefore, the
proposed definition of infusion drug administration calendar day would
result in payment only for these days when a visit occurs. Likewise,
the beneficiary would be responsible for the 20 percent coinsurance
amount only on these days. Section 1834(u)(7) requires that the
temporary transitional home infusion therapy services payment be equal
to 4 units at the amounts determined under the physician fee schedule
(that is, the equivalent of 4 hours of infusion in a physician's
office). This amount would range from $141 to $240 (using CY 2018 fee
schedule amounts). If payment were to be made every day an infusion
occurred, regardless of whether a visit was made, the beneficiary would
be responsible for the home infusion therapy services coinsurance
amount each and every day the infusion
[[Page 56583]]
occurred. For some patients on daily, continuous infusions, this would
mean paying a 20 percent coinsurance amount every day (approximately
$900 per month in cost-sharing and more than $10,000 annually). In
accordance with CMS' proposed definition of infusion drug
administration calendar day, the infusion therapy supplier would be
paid every time a visit is made and a skilled service was furnished in
the individual's home, which we anticipate would be at least weekly.
Furthermore, we believe requiring that direct patient care services be
made in order to receive payment promotes visits that provide direct
care to the patient, which may help to mitigate any infusion related
reactions or unplanned readmissions or ED visits. Similar to the
physician office and the hospital outpatient setting, Medicare payment
is made for direct care services furnished to a patient for infusion
drug administration. We believe that, clinically, it is occasionally
necessary for a nurse to visualize part of the administration of the
infusion drug as this is part of his/her overall patient assessment
while in the home. For instance, a nurse may observe dyspnea,
tachycardia, or infiltration during an infusion and can appropriately
intervene to ensure the safe and effective administration of the
infusion.
We also do not anticipate that this requirement would lead to any
additional home visits than are currently provided by home infusion
suppliers. As many commenters pointed out, visits are often provided
weekly, which aligns with what we stated in the proposed rule.
Furthermore, we consider this benefit to be an additional payment for
the direct care services associated in coordination with the furnishing
of home infusion drugs.
Comment: Some commenters expressed concern regarding availability
and categorization of specific infusions such as Total Parenteral
Nutrition (TPN), intravenous hydration, or antiemetic drugs.
Response: While ``home infusion drug'' is defined under section
1861(iii)(3)(C) as a 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,
section 1834(u)(7)(A)(iii) of the Act includes an exception to the
definition of home infusion drug if the drug is identified under
section 1834(u)(7)(C) of the Act. This provision for the temporary
transitional payment specifies the HCPCS codes for the drugs and
biologicals covered under the Local Coverage Determinations (LCD) for
External Infusion Pumps. Therefore, only these drugs are covered under
the home infusion therapy services temporary transitional payment. We
intend to examine the criteria for home infusion drugs for coverage of
home infusion therapy services, for implementation of the full home
infusion therapy benefit in 2021.
Comment: A few commenters pointed out a technical edit regarding
billing related to the creation of the G-codes and questioned whether
our intent is to create three new G-codes for each of the three payment
categories or one new G-code for each of the categories.
Response: We thank the commenters for bringing this to our
attention. To clarify, we plan on creating one new G-code for each of
the three payment categories.
Final Decision: We are finalizing the definition of infusion drug
administration calendar day for the home infusion therapy services
temporary transitional payment to mean payment is for 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. We recognize the
concerns from stakeholders and members of Congress on our
interpretation of ``infusion drug administration calendar day'',
including with respect to professional services that may be provided
outside of the home and, as applicable, payment amounts for such
services. It is our intention to ensure access to home infusion therapy
services in accordance with section 50401 of the BBA of 2018.
Therefore, we believe the best course of action is to monitor the
effects on access to care of finalizing this definition and, if
warranted and within the limits of our statutory authority, engage in
additional rulemaking or guidance regarding this definition for
temporary transitional payments. We seek comments on this
interpretation and on its potential effects on access to care.''
1. Solicitation of Public Comments Regarding Payment for Home Infusion
Therapy Services for CY 2021 and Subsequent Years
Upon the expiration of the home infusion therapy services temporary
transitional payment, we will be fully implementing the home infusion
therapy services payment system under section 1834(u)(1) of the Act, as
added by section 5012 of the 21st Century Cures Act (Pub. L. 114-255).
In the CY 2019 HH PPS proposed rule (83 FR 32340), we discussed the
provisions of the law, and in anticipation of future rulemaking,
solicited comments regarding the payment system for home infusion
therapy services beginning in CY 2021. We discussed the relationship
between the new home infusion therapy benefit and the existing Medicare
DME and home health benefits; the definition of infusion drug
administration day; payment basis, limitation on payment, required and
discretionary adjustments, and billing procedures; the professional/
nursing services and monitoring related to the administration of home
infusion drugs; and the role of prior authorization. Specifically, we
requested comments on retaining the definition of ``infusion drug
administration calendar day'', as proposed in section IV.C.2. of the
proposed rule for the full implementation of the home infusion therapy
services benefit, and invited comments on any additional
interpretations of professional, nursing, training and education, and
monitoring services that may be considered under the scope of the home
infusion therapy benefit. We solicited comments on ways to account for
therapy type and complexity of administration, as well as ways to
capture patient acuity, and requested feedback on situations that may
incur an outlier payment and potential designs for an outlier payment
calculation. And finally, we invited comments on the unit of single
payment; limitations on payment; prior authorization; and required and
discretionary adjustments, and solicited any additional suggestions as
to how qualified home infusion therapy suppliers should bill and be
paid for services under the home infusion therapy benefit, including
whether it is reasonable to require two separate claims submissions to
account for different components of home infusion therapy.
As there is overlap between the provisions of the home infusion
therapy services temporary transitional payment and the full home
infusion therapy benefit to be implemented in 2021, many of the
proposed rule comments we received pertained to both. However, while we
did not include proposals regarding payment for home infusion therapy
services for CY 2021 and beyond, we did receive several comments
related specifically to implementation of the full benefit. These
comments included suggestions regarding billing, payment basis and
adjustments, prior authorization, and
[[Page 56584]]
the relationship between the home infusion and home health benefits. We
appreciate commenters' review of, and input regarding the discussion of
the home infusion benefit, and will give careful consideration to all
comments received when implementing the permanent Medicare payment
structure for home infusion therapy services.
We did receive several technical comments regarding certain
provisions that are addressed in the responses in this section of this
final rule with comment period.
Comment: Several commenters expressed concern with retaining the
proposed definition of ``infusion drug administration calendar day''
for the full implementation of the home infusion therapy benefit in
2021 as required by the 21st Century Cures Act.
Response: While we did not formally propose a definition of
``infusion drug administration calendar day'' in the discussion of the
full implementation of the home infusion therapy benefit in 2021, we
will note that the clarification in section 1834(u)(7)(E)(i) of the
Act, as added by the BBA of 2018, regarding ``infusion drug
administration calendar day'' provides that this definition is with
respect to the furnishing of ``transitional home infusion drugs'' or
``home infusion drugs'' to an individual by an ``eligible home infusion
supplier'' or a ``qualified home infusion therapy supplier.'' As ``home
infusion drugs'' and ``qualified home infusion therapy supplier'' are
terms for the permanent benefit in the 21st Century Cures Act, this
definition of ``infusion drug administration calendar day'' would
pertain to both the temporary benefit and the full benefit.
Comment: A few commenters expressed concern with the potential
exclusion of particular drugs from the full implementation of the home
infusion therapy services benefit. Another commenter stated the
understanding that Intravenous Immune Globulin (IVIG) is covered under
the legislation enacted by the 21st Century Cures Act. Additionally,
this commenter expressed concern with the conclusion of the Medicare
IVIG demonstration as it relates to the full implementation of the home
infusion therapy benefit and encouraged CMS to expedite the final
report prior to the implementation of the benefit. Another commenter
expressed concern that, because the legislation excludes drugs and
biologicals on a self-administered drug (SAD) exclusion list, some
subcutaneous immune globulins (SCIG) that are covered under the
temporary transitional payment would be excluded from the benefit in
2021.
Response: We appreciate the commenter's concern regarding the
conclusion of the IVIG demonstration; however, the timeline of the
demonstration's final report is out of the scope of this rule. While
section 50401 of the BBA of 2018 defines ``transitional home infusion
drug'' by identifying the HCPCS codes for drugs under the LCD that are
for coverage under the home infusion therapy services temporary
transitional payment, the full implementation of the benefit in 2021 is
less specific with regard to particular home infusion drugs. Section
1861(iii)(3)(C) of the Act defines a ``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. Such term does not include insulin pump systems or
self-administered drugs or biologicals on a self-administered drug
exclusion list. We understand commenter concern regarding certain drugs
and biologicals, specifically SCIG and IVIG, and will continue to
examine the scope of drugs covered under Part B, along with the
criteria for inclusion on the Self-Administered Drug Exclusion list for
full implementation of the home infusion therapy benefit in 2021.
Comment: A commenter urged CMS to ensure that coverage guidelines
for home infusion therapy make continued coverage available even if the
beneficiary and/or family member is unwilling or unable to be trained
to assume responsibility for the infusion themselves.
Response: We should reiterate that the home infusion therapy
benefit is intended for drugs that are administered through an item of
DME. As DME must be appropriate for use in the home, DMEPOS supplier
standards require suppliers to document that they or another qualified
party provided beneficiaries with instructions and education on safe
and effective operation of the equipment (42 CFR 424.57(c)(12)). CMS
convened a technical expert panel (TEP) in August of 2018, during which
TEP members concurred that despite a physician's belief that home
infusion may be medically acceptable and appropriate for a patient,
success is very individualized and to a great extent, patient-
dependent. We solicited comments regarding a reasonable number of
visits needed to train the patient and caregiver on safe and effective
use of the pump, and many commenters supported our assumption of two
visits the first week and then weekly thereafter. We also acknowledged
that there may be patients that are unable or unwilling to self-
administer, in which case the home would not be the appropriate site of
care.
We appreciate commenter feedback and will take all comments under
consideration while implementing the permanent home infusion therapy
services benefit. We encourage commenters to submit additional comments
regarding the full implementation of the benefit to the home infusion
policy mailbox at [email protected].
VII. Changes to the Accreditation Requirements for Certain Medicare-
Certified Providers and Suppliers
A. Background
To participate in the Medicare program, Medicare-certified
providers and suppliers of health care services, must be substantially
in compliance with specified statutory requirements of the Act, as well
as any additional regulatory requirements related to the health and
safety of patients specified by the Secretary of the Department of
Health and Human Services (HHS). Medicare certified providers and
suppliers are enrolled in the Medicare program by entering into an
agreement with Medicare. They include hospitals, skilled nursing
facilities, home health agencies, hospice programs, rural health
clinics, critical access hospitals, comprehensive outpatient
rehabilitation facilities, laboratories, clinics, rehabilitation
agencies, public health agencies, and ambulatory surgical centers.
These health and safety requirements are generally called conditions of
participation (CoPs) for most providers, requirements for skilled
nursing facilities (SNFs), conditions for coverage (CfCs) for
ambulatory surgical centers (ASCs) and other suppliers, and conditions
for certification for rural health clinics (RHCs). A Medicare-certified
provider or supplier that does not substantially comply with the
applicable health and safety requirements risks having its
participation in the Medicare program terminated.
In accordance with section 1864 of the Act, state health
departments or similar agencies, under an agreement with CMS, survey
health care providers and suppliers to ascertain compliance with the
applicable CoPs, CfCs, conditions of certification, or requirements,
and certify their findings to us. Based on these State Survey Agency
(SA) certifications, we determine whether the provider or
[[Page 56585]]
supplier qualifies, or continues to qualify, for participation in the
Medicare program.
Section 1865(a) of the Act allows most health care facilities to
demonstrate compliance with Medicare CoPs, requirements, CfCs, or
conditions for certification through accreditation by a CMS-approved
program of a national accreditation body. If an AO is recognized by the
Secretary as having standards for accreditation that meet or exceed
Medicare requirements, any provider or supplier accredited by the AO's
CMS-approved accreditation program may be deemed by us to meet the
Medicare conditions or requirements.
We are responsible for the review, approval and subsequent
oversight of national AOs' Medicare accreditation programs, and for
ensuring providers or suppliers accredited by the AO meet the quality
and patient safety standards required by the Medicare CoPs,
requirements, CfCs, and conditions for certification. Any national AO
seeking approval of an accreditation program in accordance with section
1865(a) of the Act must apply for and be approved by CMS for a period
not to exceed 6 years.
The AO must reapply for renewed CMS approval of an accreditation
program before the date its approval period expires. This allows
providers or suppliers accredited under the program to continue to be
deemed to be in compliance with the applicable Medicare CoPs,
requirements, CfCs, and conditions for certification. Regulations
implementing these provisions are found at 42 CFR 488.1 through 488.9.
We believe that it is necessary to revise the regulations for
Medicare-certified providers and providers to add two new requirements
for the AOs that accredit certified providers and providers. First, we
proposed at Sec. 488.5 to require AOs for Medicare-certified providers
and suppliers to include a written statement in their application which
states that if a fully accredited and deemed facility in good standing
provides written notification that they wish to voluntarily withdraw
from the AO's CMS-approved accreditation program, the AO must continue
the facility's current accreditation until the effective date of
withdrawal identified by the facility or the expiration date of the
term of accreditation, whichever comes first. We also proposed to
modify the AO oversight regulations at Sec. 488.5 by adding new
requirements for training for AO surveyors.
B. Changes to Certain Requirements for Medicare-Certified Providers and
Suppliers at Part 488
1. Continuation of Term of Accreditation When a Medicare-Certified
Provider or Supplier Decides to Voluntarily Terminate the Services of
an Accrediting Organization (Sec. 488.5)
We proposed adding a new provision to the approval and oversight
regulations for AOs that accredit Medicare certified providers and
suppliers at Sec. 488.5(a)(17)(iii), which would require that, with an
initial or renewal application for CMS-approval of a Medicare certified
provider or supplier accreditation program, an AO must include a
written statement agreeing that when a fully accredited, deemed
provider or supplier in good standing notifies its AO that it wishes to
voluntarily withdraw from the AO's accreditation program, the AO would
honor the provider's or supplier's current term of accreditation until
the effective date of withdrawal identified by the facility, or the
expiration date of the term of accreditation, whichever comes first. We
made this proposal because we have received numerous complaints from
accredited and deemed facilities in good standing with their then-
current AO stating that once they provide notification to the AO of
their intent to voluntarily withdrawal their accreditation business
from that AO, the AO frequently terminated their accreditation
immediately, without regard to their current accreditation status, up
to date payment of fees, contract status, or the facility's requested
effective date of withdrawal. We do not believe it is reasonable for
AOs to penalize facilities because they choose to terminate the
services of an AO.
Providers and suppliers may be left without an accreditation status
that would allow them to continue to participate in Medicare.
Comment: Several commenters expressed general support for our
proposal at Sec. 488.5(a)(17)(iii), which would require that, with an
initial or renewal application for CMS-approval of a Medicare certified
provider or supplier accreditation program, AO must include a written
statement agreeing that when a fully accredited, deemed provider or
supplier in good standing notifies its AO that it wishes to voluntarily
withdraw from the AO's accreditation program, the AO would honor the
provider's or supplier's current term of accreditation until the
effective date of withdrawal identified by the facility, or the
expiration date of the term of accreditation, whichever comes first. A
commenter stated that ``we agree with this proposed change because when
a provider/supplier is accredited in good standing their accreditation
should be good for the full term of their agreement with the
accreditor.'' Another commenter stated the opinion that ``we agree that
it is unreasonable for AOs to penalize facilities who choose to
terminate the services of that AO, and as such, support this proposal.
Another commenter stated full agreement with this proposal and stated
that this is the standard operating procedure for this commenter's AO.
Response: We thank these commenters for their input.
Comment: Another commenter expressed agreement with the proposal
regarding Sec. 488.5(a)(17)(iii) and in addition, expressed the
opinion CMS should require all AOs for Medicare certified providers and
suppliers to document the dates of accreditation as the dates of the
actual survey and acceptance of the plan of correction. This commenter
argued that the requirement was necessary because AOs that accredit
large multiple site providers/suppliers use a corporate accreditation
cycle where the dates of the accreditation cycle are the same for all
sites.
Response: We thank this commenter for their support for our
proposal. We further that this commenter for the suggestion that CMS
should consider a policy applicable to AOs that accredit large multiple
site providers/suppliers which utilize a corporate accreditation cycle
where the dates of the accreditation cycle are the same for all sites.
However, this is an issue that is outside the scope of the proposed
rule. We will take this information under advisement. We thank this
commenter for bringing this concern to our attention.
Comment: A commenter expressed disapproval of our proposal, stating
the proposal, as written, undermines the autonomy of this and all other
AOs to enforce their own policies. The commenter also stated that each
AO develops its own policies and procedures related to accreditation
termination effective dates, which CMS subsequently approves.
The commenter also stated that this proposal would allow facilities
to circumvent the mechanisms AOs for Medicare certified providers and
suppliers have had in place for ongoing review of accredited
facilities. The commenter believes that the rule, as written, would
require this AO to maintain a facility's accreditation status
regardless of the commenter AO's
[[Page 56586]]
policies and procedures related to termination of a facility's
accreditation status. The commenter noted that throughout the
accreditation process, participating facilities are obligated to comply
with an AO's standards, policies, and procedures until an awarded
accreditation term expires or terminates; therefore, this proposal
would conflict with an AO's operation of its accreditation program and
its authority to make accreditation decisions. The commenter strongly
urged CMS to withdraw this requirement.
Response: We respectfully disagree with the views expressed by this
commenter. We do not agree that the requirement would undermine the
autonomy of this AO to enforce its own policies or conflict with
commenter's AOs operation of its accreditation program and its
authority to make accreditation decisions. This commenter provided no
examples or explanation for how the addition of the proposed policy
would do so.
It is our position that if an accredited provider or supplier has
paid the agreed upon accreditation fees, successfully gone through the
survey process, and is in good standing with their AO, but has, for
whatever reason, decided to switch accreditation to another AO or to
submit to a survey by a state agency, there is no justifiable reason
for the current AO to cancel that provider/suppliers accreditation
prior to the expiration date.
CMS has seen cases in which shortly after an AOs has been informed
by one of its accredited providers/suppliers in good standing that said
provide/supplier wishes to withdraw their accreditation business from
that AO and become accredited by another AO (or obtain state
certification), the current AO terminates that provider/suppliers
accreditation, regardless of how much time remains on that provider's
or supplier's existing term of accreditation. We believe that these
instances of early termination of the accreditation of a provider/
suppliers in good standing, with no performance or complaint issues who
has recently informed their AO that they were switching to another AO
are either retaliatory in nature, or done because these providers were
no longer considered a viable source of revenue. We agree that it is
unreasonable for AOs to penalize facilities who choose to terminate the
services of that AO, and as such, support this proposal.
Final Decision: In consideration of the comments received, this
provision will be added to 42 CFR 488.5(a)(17)(iii) as drafted, without
modification.
2. Training Requirements for Accrediting Organization Surveyors (Sec.
488.5(a)(7))
We proposed to add a new requirement at Sec. 488.5(a)(7) which
imposes a new training requirement for surveyors of AO that accredit
Medicare-certified provider and supplier types by amending the
provision at Sec. 488.5(a)(7). We proposed that all AO surveyors be
required to complete the relevant program-specific CMS online trainings
initially, and thereafter, consistent with requirements established by
CMS for state surveyors. CMS provides a wide variety of comprehensive
trainings through an on-demand integrated surveyor training website.
These online trainings are available and can be accessed by state and
federal surveyors and the public, free of charge, 24 hours a day, 365
days a year. These online trainings are currently publically available
for the SA surveyors.
As part of our oversight of the AOs performance, CMS has contracted
with the SAs to perform validation surveys on a sample of providers and
suppliers (such as hospitals, critical access hospital, ambulatory
surgical centers, and home health agencies) accredited by the AOs that
accredit Medicare certified providers and suppliers. Validation surveys
must be performed by the SA within 60 days of the survey performed by
the AO. As a validation survey is performed within 60 days of the AO
survey, we believe that the conditions at the hospital or other
facility being surveyed will be similar at the time of the validation
survey.
The purpose of a validation survey is to compare the survey
findings of the AO to the survey findings of the SA to see if there are
any disparities. The amount of disparities found in the AO's survey is
called the ``disparity rate'' and is tracked by CMS as an indication of
the quality of the surveys performed by the AO.
CMS has determined that many of the AOs' disparity rates have been
consistently high. This means that the AOs have consistently failed to
find the same condition level deficiencies in the care provided by the
hospital or other providers surveyed that were found by the SA during
the validation survey.
At the time of the writing of the proposed rule, we believed that
the disparity in findings made by the AO surveyors and those of the SA
surveyors could largely be attributed the difference in the training
and education provided to the AO surveyors. Each AO is responsible for
providing training and education to their surveyors. In the proposed
rule, we stated that because each AO is an independent entity, the
surveyor training and education provided by each AO to its surveyor's
varies and is not consistent. We further stated that CMS provides
comprehensive online training to the SA surveyor staff on the CMS
Surveyor Training website \82\ which are specific to each type of
provider of supplier type to be surveyed.
---------------------------------------------------------------------------
\82\ https://surveyortraining.cms.hhs.gov/.
---------------------------------------------------------------------------
In the proposed rule, we stated that it was our belief that the
AO's disparity rate would be decreased if all surveyors took the same
training. We further stated the belief that completion of the same
surveyor training by both SA and AO surveyors would increase the
consistency between the results of the surveys performed by the SAs and
AOs and have a positive impact on the historically high disparity rate.
Therefore, we proposed that all AO surveyors be required to take the
CMS online surveyor training offered on the CMS website. We further
proposed to require each AO to provide CMS with documentation which
provides proof that each surveyors had completed the CMS online
surveyor training. Finally, we proposed that if the AO fails to provide
this documentation, CMS could place the AO on an accreditation program
review pursuant to Sec. 488.8(c). We received a number of comments in
response to this proposals.
Comment: Several commenters stated strong support CMS' proposal to
require consistent, comprehensive training for AO surveyors.
Response: We thank these commenters for their support of our
proposal.
Comment: Another commenter who supported CMS' proposal to require
consistent, comprehensive training for AO surveyors stated that they
did not believe the proposal went far enough. This commenter
recommended that CMS undertake a rigorous review of the entire ``deemed
status'' system. This commenter further stated concern that since these
deemed-status health care providers are not subject to routine state
certification surveys, they are not subject to the civil monetary
penalties that could result from surveys conducted by state agencies.
This commenter urged CMS to fix the flaws and loopholes in the deemed
status program.
Response: We thank this commenter for their support of the proposal
to require AO surveyors to take the CMS online surveyor training. We
further thank this commenter for the remainder of their suggestions. As
these suggestions are outside the scope of the
[[Page 56587]]
topics discussed in the proposed rule they will not be discussed here.
However, we will take this commenters suggestions under advisement.
Comment: Several commenters urged CMS to consider including a
corresponding decrease in CMS validation surveys for those AOs whose
surveyors have completed the training, since the CMS online surveyor
training which is supposed to decrease the disparity rate. Another
commenter suggested that CMS resources devoted to validation surveys
could be reduced, saving taxpayer dollars and lessening HHA time and
effort spend on largely redundant surveys.
In support of the request to decrease the number of validation
surveys to be performed if this requirement for surveyor training is
finalized, a commenter pointed out that there are other administrative
reviews including the RAC, Pre Claim Review, Probe & Educate, and
routine MAC ADR probes that could assess an AOs compliance and
performance. Another commenter stated that while there are ample
enforcement tools, CMS has not clearly targeted these efforts to bad
actors and high-value HHAs have had to divert resources from direct
care to administrative functions. This commenter suggestion that audit
frequency should be determined using current data along with Program
for Evaluating Payment Patterns Electronic Report (PEPPER) reports to
identify underperforming and/or noncompliant agencies and that audits
should be limited to topics within statutory and regulatory parameters.
Response: CMS is currently in the process of reviewing and
redesigning the validation process in an effort to make it more
accurate, effective and less burdensome for facilities. While outside
the scope of the proposals made, we will take the suggestions made by
these commenters under advisement.
Comment: In this section of this final rule with comment period is
a summary of the remainder of the comments received in response to our
response to our proposal to require surveyors for the AOs that accredit
Medicare certified providers and suppliers to the take CMS online
surveyor training:
A commenter recommended that CMS make the online surveyor
trainings available but not mandatory for all AO surveyor so that each
AO could then evaluate its own training and education materials and
make an independent decision regarding how best to use the CMS training
tools.
A commenter stated that they support the CMS aim of
reducing disparity rates, but that they cannot support the proposal as
written due to its vagueness.
Another commenter stated that the proposed rule offers
little guidance on CMS implementation of this new requirement. Another
commenter expressed concern regarding how this requirement would be
fully operationalized.
A commenter noted that the proposed rule does not specify
the CMS online training courses for which it expects completion.
Another commenter expressed the concern that it is unclear from the
text of this rule, how often surveyors would be required to participate
in the training.
Several commenters stated the belief that there are
ambiguities in the proposal that essentially create further opportunity
for non-uniformity in surveyor training across the industry. Any non-
uniformity in training could reduce the meaningfulness of any presumed
links between surveyor training mandates and disparity rates that CMS
hopes to identify and impact.
Another commenter requested more clarity concerning
training requirements including course enrollment expectations,
frequency of course completion, and clarification regarding whether CMS
intends to implement a reporting mechanism for AOs to validate surveyor
course completion. This commenter expressed concern that, while the
proposed rule proposed completion of ``relevant program specific CMS
online trainings established for state surveyor,'' the variety of
online training programs offered and the lack of specificity over the
precise training modules required per program could create confusion
over which precise training elements would be required for full rule
compliance.
Another commenter expressed doubt that a mandatory
requirement for AO surveyors to take CMS online surveyor training would
improve AO the disparity rates, and that reviewing online training does
not guarantee surveyors will retain and then apply all the information
from the trainings during their surveys.
Several commenters strongly suggested that CMS needs to
establish a measurable correlation between the proposal and the
expected outcome before CMS proposes to require AOs to implement any
costly program.
Several commenters suggested that if CMS has questions and
concerns with the current surveyor education provided by AOs, it seems
like this would be an issue to be addressed when reevaluating that AO's
own accreditation from CMS.
A commenter also made the suggestion that CMS should also
evaluate the length of surveys and determine whether it would make
sense to have a minimum (or standard) length for all individuals
surveying for a specific provider or supplier type. Or have a minimum
(or standard) number of surveyors participating in each survey. This
commenter stated the belief that there could be a number of factors
involved in the disparity rate.
Several commenters stated that they do not agree with CMS'
assumptions that inconsistent training between SA surveyors and AO
surveyors is the reason for high disparity rates. One of these
commenters stated that they fail to see the correlation between
different AO surveyor training programs and disparity rates when the
disparity rate is a comparison of an SA survey result against an AO
survey result and not a comparison between AOs.
Another commenter recognizes that disparity rates are a
constant challenge for CMS and AOs, and that root-cause factors driving
high disparity rates are complex and multi-faceted. Yet another of
these commenters stated that while surveyor training may be a factor
that influences disparity rates, it is unclear whether mandating that
AOs to require that surveyors complete CMS training modules will
actually reduce the disparity rate. The hypothesis that mandating
additional AO surveyor training will lower disparity rates is untested
and unproven, and the basis for the hypothesis is unclear.
Several commenters expressed the belief that unknown or
alternative factors may truly drive high disparity rates and that there
are multiple explanations as to why the disparity rate could be
elevated that are not related to surveyor training. For example,
according to these commenters, it is possible that there could be
variance or issues with the validation surveyors. Reviewing online
training does not guarantee surveyors will retain and then apply all
the information from the trainings during their surveys.
A number of commenters raised the following points in
objection to our proposal that AO surveys complete CMS-provided
mandatory surveyor training:
++ CMS reviews and approves all AO training, verifying its
adequacy.
++ State agency surveyors are not required to have actual
experience in the health care field for which they survey. This
commenter stated that at least one accreditor requires a minimum of 5
years' experience in the same field that they will survey, thus making
them a subject matter expert.
++ State agencies send multiple surveyors for multiple days, where
AOs
[[Page 56588]]
usually send one surveyor for 2 to 5 days. The length of the survey
depends on the number of unduplicated admissions the facility bills
over a 12 month period.
++ State agencies cite the same deficiencies multiple times. AOs
normally do not.
++ There is not an appeal process for the AO in regard to a
validation survey. When a validation survey comes back with
deficiencies that the AO did not cite and does not agree with, CMS only
accepts the state validation surveyors' deficiencies as accurate.
Several commenters expressed concern that this new
requirement would place significant new burden on AOs.
A commenter recommended that CMS delay implementation of the
current proposal, and instead bring together accreditation
organizations and providers and suppliers to more fully explore how to
improve disparity rates between AO and validation surveys. Several
other commenters encouraged CMS to engage the AOs directly in both the
initiative to reduce disparity rates and on any initiatives that may
impact AO accreditation program operations.
General Response: We agree with these commenters that the text of
this section of the proposed rule may have been unclear about how the
requirement for online surveyor training was to be operationalized and
that it was not clear about the number and types of training the AO
surveyor would have to take. While we do believe that the disparity
rate would be decreased somewhat by the requirement that AO surveyors
take the CMS online surveyor training, at this time CMS is not able to
demonstrate that such training will significantly reduce the validation
disparity rate. After consideration of the comments received, we
acknowledge that root-cause factors driving high disparity rates are
complex and multi-faceted and that there are a number of other factors
that could have an impact on the disparity. We also acknowledge that
while surveyor training may be a factor that influences disparity
rates, it is unclear whether requiring that AOs require that surveyors
complete CMS training modules will reduce the disparity rate.
Therefore, after consideration of the comments received, we have
decided not to finalize our proposal to require the surveyors for AOs
that accredit Medicare certified providers and suppliers to take the
CMS online surveyor training. However, it is important to note that
many of the AOs' disparity rates have been consistently high. We are
continuing to monitor these rates and look for ways to reduce them.
Final Decision: After consideration of the comments received, we
have decided not to finalize our proposal to require the surveyors for
AOs that accredit Medicare certified providers and suppliers to take
the CMS online surveyor training.
VIII. Requests for Information
This section addressed two requests for information (RFI).
A. Request for Information on Promoting Interoperability and Electronic
Healthcare Information Exchange Through Possible Revisions to the CMS
Patient Health and Safety Requirements for Hospitals and Other
Medicare- and Medicaid-Participating Providers and Suppliers
In the CY 2019 HH PPS proposed rule (83 FR 32471 through 32473), we
included a Request for Information (RFI) related to promoting
interoperability and electronic health care information exchange. We
received approximately 28 timely pieces of correspondence on this RFI.
We appreciate the input provided by commenters.
B. Request for Information on Price Transparency: Improving Beneficiary
Access to Home Health Agency Charge Information
In the CY 2019 HH PPS proposed rule (83 FR 32473 and 32474), we
included a Request for Information (RFI) related to price transparency
and improving beneficiary access to home health agency charge
information. We received approximately 15 timely pieces of
correspondence on this RFI. We appreciate the input provided by
commenters.
IX. 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.
A. Wage Estimates
To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2017 National Occupational Employment and Wage
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, the following Table 42 presents the mean
hourly wage rate, fringe benefits costs and overhead (calculated at 100
percent of salary), and the adjusted hourly wage.
[[Page 56589]]
[GRAPHIC] [TIFF OMITTED] TR13NO18.076
This final rule with comment period makes reference to associated
information collections that are not discussed in the regulation text
contained in this document. These final changes are associated with the
information collection request (ICR)--Outcome and Assessment
Information Set (OASIS) OASIS-C2/ICD-10 (CMS-10545), approved under OMB
control number 0938-1279. We note that on March 12, 2018 (83 FR 10730)
we published a notice in the Federal Register seeking public comment on
a revision to CMS-10545 (OMB control number 0938-1279), which will
modify the OASIS and refer to the revised item set as the OASIS-D upon
implementation of the revised data set on January 1, 2019 . We
solicited public comment on additional changes related to when certain
OASIS items are required to be completed by HHA clinicians due to the
implementation of the patient-driven groupings model (PDGM) for CY
2020, as outlined in section III.F of this final rule with comment
period; and the changes to due to the removal of HH QRP measures
beginning with the CY 2021 HH QRP, as outlined in section V.E. of this
final rule with comment period.
B. ICRs Regarding the OASIS
We believe that the burden associated with the OASIS is the time
and effort associated with data collection and reporting. As of April
1, 2018, there are approximately 11,623 HHAs reporting OASIS data to
CMS.
In section V.E.1. of this final rule with comment period, we are
removing the Depression Assessment Conducted Measure from the HH QRP
under measure removal Factor 1: Measure performance among HHAs is so
high and unvarying that meaningful distinctions in improvements in
performance can no longer be made. Removing this measure will not
impact our collection of information because OASIS Item M1730, which is
used to calculate this measure, is also used as a risk adjuster to
calculate other OASIS-based outcome measures currently adopted for the
HH QRP.\83\
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\83\ The OASIS-based HH QRP outcome measures that use OASIS Item
M1730 as a risk adjuster in the calculation of the measure are:
Improvement in Bathing (NQF #0174), Improvement in Bed Transferring
(NQF #0175), Improvement in Ambulation/Locomotion (NQF #0167),
Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), Improvement in Management of Oral Medications
(NQF #0176), and Improvement in Status of Surgical Wounds (NQF
#0178).
---------------------------------------------------------------------------
In section V.E.2. of this final rule with comment period, we are
removing the Diabetic Foot Care and Patient/Caregiver Education
Implemented during All Episodes of Care Measure from the HH QRP under
measure removal Factor 1: Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made. This measure is calculated using OASIS Item
M2401, row a at the time point of Transfer to an Inpatient Facility
(TOC) and Discharge from Agency--Not to an Inpatient Facility
(Discharge). Specifically, we are removing this one data element at the
TOC and Discharge time points.
In section V.E.3. of this final rule with comment period, we are
removing the Multifactor Fall Risk Assessment Conducted For All
Patients Who Can Ambulate (NQF #0537) Measure from the HH QRP under
measure removal Factor 1: Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made. This measure is calculated using OASIS Item
M1910 at the time point of SOC/ROC. Specifically, we are removing this
one data element at the SOC/ROC time point.
In section V.E.4. of this final rule with comment period, we are
removing the Pneumococcal Polysaccharide Vaccine Ever Received Measure
from the HH QRP, under measure removal Factor 3: A measure does not
align with current clinical guidelines or practice. This measure is
calculated using OASIS Items M1051 and M1056 at the time points of TOC
and Discharge. Specifically, we are removing these two data elements at
the TOC and Discharge time points.
In section V.E.5. of this final rule with comment period, we are
removing the Improvement in the Status of Surgical Wounds Measure from
the HH QRP under measure removal Factor 4: A more broadly applicable
measure (across settings, populations, or conditions) for the
particular topic is available. Removing this measure will not impact
our collection of information because OASIS Items M1340 and M1342 are
used as risk adjusters to calculate other OASIS-based outcome measures
currently adopted for the HH QRP and OASIS Items M1340 and M1342 are
also used for the Potentially Avoidable Events measure Discharged to
the Community Needing Wound Care or Medication Assistance that is used
by HH surveyors during the survey process.84 85
---------------------------------------------------------------------------
\84\ The OASIS-based HH QRP outcome measures that use OASIS
Items M1340 and M1342 as a risk adjuster in the calculation of the
measure are: Improvement in Bathing (NQF #0174), Improvement in Bed
Transferring (NQF #0175), Improvement in Ambulation/Locomotion (NQF
#0167), Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), and Improvement in Management of Oral
Medications (NQF #0176).
\85\ Measure specifications can be found in the Home Health
Potentially Avoidable Events Measures Table on the Home Health
Quality Measures website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-PAE-Measures-Table-OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
In sections V.E.6. and V.E.7. of this final rule with comment
period, we are removing the Emergency Department Use without Hospital
Readmission during the First 30 Days of HH (NQF #2505) Measure and the
Rehospitalization during the First 30
[[Page 56590]]
Days of HH (NQF #2380) Measure from the HH QRP beginning with the CY
2021 HH QRP under measure removal Factor 4. A more broadly applicable
measure (across settings, populations, or conditions) for the
particular topic is available. Because these are both claims-based
measures, removing them will not impact our collection of information.
In summary, we are finalizing the net reduction of 1 data element
at SOC, 1 data element at ROC, 3 data elements at TOC and 3 data
elements at Discharge associated with OASIS item collection as a result
of the measure removals from the HH QRP.
The OASIS instrument is used for meeting the home health Conditions
of Participation, requirements under the HH QRP, and for payment
purposes under the HH PPS. As outlined in section III.F. of this final
rule with comment period, to calculate the case-mix adjusted payment
amount for the PDGM, we are finalizing our proposal to add collection
of two current OASIS items (10 data elements) at the follow-up (FU)
time point:
M1033: Risk for Hospitalization (9 data elements)
M1800: Grooming (1 data element).
As outlined in section III.F of this final rule with comment
period, several OASIS items will not be needed in case-mix adjusting
the period payment for the PDGM; therefore, 19 current OASIS items (48
data elements) are optional at the FU time point:
M1021: Primary Diagnosis (3 data elements)
M1023: Other Diagnosis (15 data elements)
M1030: Therapies (3 data elements)
M1200: Vision (1 data element)
M1242: Frequency of Pain Interfering (1 data element)
M1311: Current Number of Unhealed Pressure Ulcers at Each
Stage (12 data elements)
M1322: Current Number of Stage 1 Pressure Ulcers (1 data
element)
M1324: Stage of Most Problematic Unhealed Pressure Ulcer that
is Stageable (1 data element)
M1330: Does this patient have a Stasis Ulcer? (1 data element)
M1332: Current Number of Stasis Ulcer(s) that are Observable
(1 data element)
M1334: Status of Most Problematic Stasis Ulcer that is
Observable (1 data element)
M1340: Does this patient have a Surgical Wound (1 data
element)
M1342: Status of Most Problematic Surgical Wound that is
Observable (1 data element)
M1400: Short of Breath (1 data element)
M1610: Urinary Incontinence or Urinary Catheter Presence (1
data element)
M1620: Bowel Incontinence Frequency (1 data element)
M1630: Ostomy for Bowel Elimination (1 data element)
M2030: Management of Injectable Medications (1 data element)
M2200: Therapy Need (1 data element)
Therefore, we are finalizing the net reduction of 38 data elements
at FU associated with OASIS item collection as a result of the
implementation of the PDGM for CY 2020.
In summary, as a net result of the policies we are finalizing in
this final rule with comment period, we will be removing 1 data element
at SOC, 1 data element at ROC, 38 data elements at FU, 3 data elements
at TOC and 3 data elements at Discharge associated with OASIS item
collection as a result of the measure removals from the HH QRP and the
implementation of the PDGM starting January 1, 2020.
We assume that each data element requires 0.3 minutes of clinician
time to complete. Therefore, we estimate that there is a reduction in
clinician burden per OASIS assessment of 0.3 minutes at SOC, 0.3
minutes at ROC, 11.4 minutes at FU, 0.9 minutes at TOC and 0.9 minutes
at Discharge.
The OASIS is completed by RNs or physical therapists (PTs), or very
occasionally by occupational therapists (OT) or speech language
pathologists (SLP/ST). Data from 2016 show that the SOC/ROC OASIS is
completed by RNs (approximately 87 percent of the time), PTs
(approximately 12.7 percent of the time), and other therapists,
including OTs and SLP/STs (approximately 0.3 percent of the time). We
estimated a weighted clinician average hourly wage of $70.75, inclusive
of fringe benefits, using the hourly wage data in Table 41. Individual
providers determine the staffing resources necessary.
Table 43 shows the total number of assessments submitted in CY 2017
and estimated burden at each time point.
[GRAPHIC] [TIFF OMITTED] TR13NO18.077
Based on the data in Table 43 for the 11,623 active Medicare-
certified HHAs in April 2018, we estimate the total average decrease in
cost associated with changes with OASIS item collection at $5,148.94
per HHA annually, or $59,846,101.27 for all HHAs annually. This
corresponds to an estimated reduction in clinician burden associated
with changes to collection of information associated with the OASIS of
72.8 hours per HHA annually, or
[[Page 56591]]
845,881.3 hours for all HHAs annually. This burden decrease will be
accounted for in the information collection under OMB control number
0938-1279. We did not receive comments on collection of information
requirements associated with the OASIS.
C. ICRs Regarding Home Infusion Therapy
At Sec. 486.520, Plan of Care, we propose that all patients must
have a plan of care established by a physician that prescribes the
type, amount, and duration of infusion therapy services that are to be
furnished. This requirement directly implements section 5012 of the
21st Century Cures Act. Accredited home infusion therapy suppliers are
already required by their accrediting bodies to provide all care in
accordance with a plan of care that specifies the type, amount, and
duration of infusion therapy services to be furnished to each patient;
therefore this requirement will not impose a burden upon accredited
agencies. Furthermore, all existing home infusion therapy suppliers are
already accredited due to existing payment requirements established by
private insurers and Medicare Advantage plans. In accordance with the
implementing regulations of the PRA at 5 CFR 1320.3(b)(3), this
requirement exists even in the absence of a federal requirement;
therefore, the associated burden is not subject to the PRA. We did not
receive any comments from the public, either in agreement or
opposition, regarding our estimation of burden for information
collection requirements in relation to the implementation of the home
infusion therapy standards as delineated by section 5012 of the 21st
Century Cures Act; therefore, we are finalizing this estimate without
modification.
We did not receive any comments from the public, either in
agreement or opposition, regarding our estimation of burden for
information collection requirements in relation to the implementation
of the home infusion therapy standards as delineated by section 5012 of
the 21st Century Cures Act; therefore, we are finalizing this estimate
without modification.
D. ICRs Regarding the Approval and Oversight of Accrediting
Organizations for Home Infusion Therapy
1. Background
We are finalizing establish a new set of regulations related to the
approval and oversight of accrediting organizations that accredit home
infusion therapy suppliers. If finalized, these new regulatory
requirements will impose burden on those new AOs that seek approval of
their Home Infusion Therapy accreditation program. This burden will
include, but is not limited to the time and costs associated with the
following activities: (1) Preparation and filing of an initial
application seeking CMS approval of the AOs home infusion therapy
accreditation program; (2) participation in the application review
process (that is, meetings, provide additional information and
materials that may be required, participate in a site visit, etc.); (3)
seeking new accreditation clients; (4) performing on-site surveys, off-
site survey audits or the performance of other types of survey
activities; (5) participation in CMS ongoing accreditation program
review activities; (6) performance of periodic re-accreditation
activities; (7) investigation of complaints and performing complaint
surveys; (8) administration of the appeals process for providers that
have been denied accreditation; (9) staff training, in-services and
continuing education; and (10) ensuring that surveyor staff have the
proper education, training, and credentials.
The following is a discussion of the potential ICR burdens
associated with the home infusion therapy supplier accreditation
oversight regulations and well as any PRA exceptions that may apply.
2. Applicable PRA Exception
We believe that the information collection burden associated with
the preparation and submission of an initial or renewal application for
approval and designation as a home infusion therapy AO and the
participation in other accreditation related activities does not meet
the definition of ``collection of information'' as defined in 5 CFR
1320.3(c) because it is ``not imposed on 10 or more persons.'' This
information collection burden will be imposed only on those national
AOs that accredit home infusion therapy suppliers.
At this time, there are five CMS-approved HHA AOs that provide home
infusion therapy accreditation as part of the deeming accreditation of
home health agencies. These HHA AOs are The Joint Commission (TJC), the
Accreditation Commission for Health Care (ACHC), The Compliance Team
(TCT), the Community Health Accreditation Partner (CHAP), and the
Healthcare Quality Association on Accreditation.
There are three pharmacy association AOs that provide non-CMS
approved home infusion therapy accreditation. These non-CMS approved
Home infusion AOs are the National Association of Boards of Pharmacy,
the Centers for Pharmacy Practice Accreditation (CPPA) and URAC).
In this final rule with comment period, we have to require that
these AO must apply for CMS approval of a home infusion therapy
accreditation that is separate and distinct from its home health
accreditation program. When we do solicit AOs to accredit home infusion
therapy suppliers, we do not anticipate receiving more than the six
applications which will be submitted by the existing AOs seeking
approval of a home infusion therapy accreditation program, because this
is a specialized area of accreditation.
It is possible that the number of AOs that we designate to accredit
home infusion therapy suppliers may increase to 10 or more in the
future, when we begin accepting applications for home infusion therapy
AOs. However, we do not anticipate that the number of AOs that will
accredit home infusion therapy suppliers will increase to 10 or more in
the foreseeable future.
Should the number of AOs that accredit home infusion therapy
suppliers rise to 10 or more, we will prepare and submit an information
collection request (ICR) for the burden associated with the
accreditation process, as well as obtain OMB approval, prior to
accepting additional applications.
We did not receive comments on these information collection
requirements.
E. ICR Regarding Modifications to 42 CFR 488.5
We are modifying the AO approval and oversight regulations for
Medicare certified providers and suppliers by adding a new requirement.
Section 488.5(a)(17)(iii) will require that the AOs for Medicare
certified providers and suppliers include a written statement in their
application for CMS approval agreeing that if a fully accredited and
deemed facility in good standing provides written notification that
they wish to voluntarily withdraw from the accrediting organization's
CMS-approved accreditation program, the accrediting organization must
continue the facility's current accreditation in full force and effect
until the effective date of withdrawal identified by the facility or
the expiration date of the term of accreditation, whichever comes
first.
An AO would prepare this written statement as part of the
preparation of the initial or renewal applications they submit to CMS
seeking initial and renewal approval of the CMS approval
[[Page 56592]]
of their accreditation program. This statement would be included in a
written document with other required written statements. As the AO
would already be in the process of preparing the documentation for
their application, we believe that there would be little, if any burden
associated with the preparation of this statements.
We believe that it would take no more than 15 minutes for the AO to
add this statement to the written document containing all the
statements and affirmations that AO must submits as a condition of
approval. We believe that this task would be performed by an
administrative assistant. According to the U.S. Bureau of Labor
Statistics, the mean hourly wage for an executive administrative
assistant is $28.56 (https://www.bls.gov/oes/current/oes436011.htm). We
estimate that the AO would incur a cost burden for wages related to the
preparation of the required statement in the amount of $14.28 ($28.56 x
15 minutes = $7.14) + ($7.14 for fringe benefits and overhead).
We had also proposed to add a new requirement at Sec. 488.5(a)(7)
to require surveyors for AOs that accredit non-certified providers and
suppliers to take the CMS online surveyor training. However, after
consideration of the public comments received regarding this proposal,
we have decided not to finalize the proposal.
F. Submission of PRA-Related Comments
We have submitted a copy of this final rule with comment period to
OMB for its review of the rule's information collection and
recordkeeping requirements. The requirements are not effective until
they have been approved by OMB.
We invite public comments on these information collection
requirements. If you wish to comment, please identify the rule (CMS-
1689-F) and, where applicable, the ICR's CFR citation, CMS ID number,
and OMB control number.
To obtain copies of a supporting statement and any related forms
for the collection(s) summarized in this notice, you may make your
request using one of following:
1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
See this rule's DATES and ADDRESSES sections for the comment due
date and for additional instructions.
X. 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 require the standard
prospective payment amount to be adjusted for case-mix and geographic
differences in wage levels. Section 1895(b)(4)(B) of the Act requires
the establishment of 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 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 require the standard
prospective payment amount to be adjusted for case-mix and geographic
differences in wage levels. Section 1895(b)(4)(B) of the Act requires
the establishment of 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.
Section 1895(b)(2) of the Act and section 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 section 51001(a)(3) of
the BBA of 2018, requires the Secretary to eliminate the use of the
[[Page 56593]]
number of therapy visits provided to determine payment, also effective
for CY 2020.
Finally, the HHVBP Model applies a payment adjustment based on an
HHA's performance on quality measures to test the effects on quality
and expenditures.
2. Home Infusion Therapy
Section 1861(iii) of the Act, as added by the Cures Act, sets forth
three elements for home infusion therapy suppliers in three areas: (1)
Ensuring that all patients have a plan of care established and updated
by a physician that sets out the care and prescribed infusion therapy
necessary to meet the patient-specific needs, (2) having procedures to
ensure that remote monitoring services associated with administering
infusion drugs in a patient's home are provided, and (3) having
procedures to ensure that patients receive education and training on
the effective use of medications and equipment in the home. These
provisions serve as the basis for suppliers to participate in Medicare.
Section 1834(u) of the Act serves as the basis for the
establishment of a prospective payment system for home infusion therapy
covered under Medicare. Section 1834(u)(7) of the Act, as added by BBA
of 2018 requires the Secretary to provide a temporary transitional
payment to 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.D. of this final rule with comment period), the
Secretary will establish three payment categories at amounts equal to
the amounts determined under the Physician Fee Schedule established
under section 1848 of the Act for services furnished during CY 2019 for
codes and units of such codes, determined without application of the
geographic adjustment.
Section 1834(u)(5)(B) of the Act requires the Secretary to
designate organizations to accredit qualified home infusion therapy
suppliers furnishing home infusion therapy no later than January 1,
2021. 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 accrediting organization
designated and approved by the Secretary; and meet other such
requirements as the Secretary deems appropriate.
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).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). The net transfer impact related to the changes in payments under
the HH PPS for CY 2019 is estimated to be $420 million (2.2 percent).
The net transfer impact in CY 2020 related to the change in the unit of
payment under the PDGM is estimated to be $0 million as section
51001(a) of the BBA of 2018 requires such change to be implemented in a
budget-neutral manner. The net transfer impact in CY 2019 related to
the Temporary Transitional Payment for Home Infusion Therapy is
estimated to be $48 million. The savings impacts related to the HHVBP
model as a whole are estimated at $378 million for CYs 2018 through
2022. Due to the modifications to OASIS item collection as a result of
the changes to the HH QRP and the changes to the HH PPS (PDGM), both
effective on and after January 1, 2020, we estimate that this rule
generates $60 million in annualized cost savings, or $46 million per
year on an ongoing basis discounted at 7 percent relative to year 2016,
over a perpetual time horizon beginning in CY 2020. Finally, the
estimated cost impact to each potential home infusion therapy AO is
$35,711. The cost of $12,453 would be incurred by the home infusion AO
for the preparation and submission of their initial application to CMS
seeking CMS approval of the AO's home infusion therapy accreditation
program. The AO will incur this $12,453 cost with the submission of
their initial application and then every 6 years thereafter, with the
submission of their renewal application. The remaining costs of
$23,258, which represents the costs associated with the home infusion
therapy AO`s participation in ongoing CMS AO overview, monitoring and
program review activities will be incurred on a bi-yearly basis.
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.
C. Anticipated Effects
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 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
[[Page 56594]]
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.
Therefore, the Secretary has determined that this HH PPS final rule
would have a significant economic impact on a substantial number of
small entities.
In addition, section 1102(b) of the Act requires us to prepare a
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 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 would 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 2018, 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 final 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. 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 commenters on this year's final
rule would be the similar to the number of reviewers of last year's
final rule. We acknowledge that this assumption may understate or
overstate the costs of reviewing this rule. It is possible that not all
commenters reviewed this year's rule in detail, and it is also possible
that some reviewers chose not to comment on the proposed rule. For
these reasons we believe that the number of past commenters would be a
fair estimate of the number of reviewers of this rule. We welcome any
comments on the approach in estimating the number of entities which
would review this final rule with comment period. 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. Using the wage information
from the BLS for medical and health service managers (Code 11-9111), we
estimate that the cost of reviewing this rule is $107.38 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 5.3 hours for
the staff to review half of this final rule with comment period, which
consists of approximately 160,000 words. For each HHA that reviews the
rule, the estimated cost is $569.11 (5.3 hours x $107.38). Therefore,
we estimate that the total cost of reviewing this regulation is
$767,729.39 ($569.11 x 1,349 reviewers).
1. HH PPS
a. HH PPS for CY 2019
The update set forth in this rule applies to Medicare payments
under HH PPS in CY 2019. Accordingly, the following analysis describes
the impact in CY 2019 only. We estimate that the net impact of the
policies in this rule is approximately $420 million in increased
payments to HHAs in CY 2019. We applied a wage index budget neutrality
factor and a case-mix weight budget neutrality factor to the rates as
discussed in section III.C.3 of this final rule with comment period.
Therefore, the estimated impact of the 2019 wage index and the
recalibration of the case-mix weights for CY 2019 is $0 million. The
$420 million increase reflects the distributional effects of the CY
2019 home health payment update of 2.2 percent ($420 million increase),
a 0.1 percent increase in payments due to the new lower FDL ratio,
which will increase outlier payments in order to target to pay no more
than 2.5 percent of total payments as outlier payments ($20 million
increase) and a 0.1 percent decrease in payments due to the new rural
add-on policy mandated by the BBA of 2018 for CY 2019 ($20 million
decrease). The $420 million in increased payments is reflected in the
last column of the first row in Table 44 as a 2.2 percent increase in
expenditures when comparing CY 2018 payments to estimated CY 2019
payments.
With regard to options for regulatory relief, the rural add-on
policy for CYs 2019 through 2022 is statutory and we do not have the
authority to alter the methodology used to categorize rural counties or
to revise the rural add-on percentages.
b. HH PPS for CY 2020 (PDGM)
We estimate no net impact of the policies related to the
implementation of the PDGM for the CY 2020 HH PPS, as the transition to
the 30-day unit of payment is required to be budget neutral. However,
since the PDGM eliminates the use of therapy thresholds as a factor in
determining payment, HHAs that provide more nursing visits, and thus
experience lower margins under the current payment system which may
incentivize overutilization of therapy, may experience higher payments.
Conversely, HHAs that provide more therapy visits compared to nursing
visits, and thus may profit more from the current payment system, may
experience lower payments.
c. Elimination of Recertification Requirement To Estimate How Much
Longer Home Health Services Will Be Required
Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act require, as a
condition of payment, that a physician must certify (and recertify,
when home health services are furnished over a period of time) that the
individual is eligible for home health services. The regulations at
Sec. 424.22(b)(2) set forth the content and basis for recertification
requirements and states that the recertification statement must
indicate the continuing need for services and estimate how much longer
the services will be required. This requirement has been longstanding
policy that predates the Paperwork Reduction Act of 1995 requirements.
Therefore, there is no corresponding Collection of Information that was
submitted to the Office of Management and Budget (OMB) for review and
approval for the burden estimate for the recertification requirement
that the certifying physician must estimate how much longer home health
services will be required.
[[Page 56595]]
In section III.G. of this final rule with comment period, we
eliminate the regulatory requirement as set forth at 42 CFR
424.22(b)(1), that the certifying physician, as part of the
recertification process, include an estimate of how much longer home
health services will be required at each home health recertification.
While all other recertification content requirements under Sec. 424.22
will remain unchanged, the certifying physician would not be required
to provide his/her estimation as to how much longer the patient will
require home health services on recertifications on and after January
1, 2019. Therefore, we believe this would result in a reduction of
burden for certifying physicians by reducing the amount of time
physicians spend on the recertification process and we are providing an
estimate on the reduction in burden in this final rule with comment
period. All salary information is based on the May 2017 wage data for
physicians and surgeons from the Bureau of Labor Statistics (BLS)
website at (https://www.bls.gov/oes/current/oes291069.htm) and includes
a fringe benefits and overhead worth 100 percent of the base salary.
Using CY 2017 claims, we estimate that of the total number of
Medicare home health claims (5.8 million), 37 percent were
recertifications (2.1 million) completed by 284,615 certifying
physicians.\86\ Of those 2.1 million recertifications, we estimate that
the time needed to recertify patient eligibility will decrease by 2
minutes per recertification with a total reduction of 69,930 physician
hours for all recertifications as a result of eliminating the time
estimation statement. Based on the physician's hourly wage of $203.26
as described previously ($101.63 with 100 percent fringe benefits and
overhead), this results in an overall annualized cost savings of $14.2
million beginning in CY 2019.
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\86\ CY 2017 OASIS assessments matched to Medicare FFS claims
(as of March 2, 2018).
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2. HHVBP Model
Under the HHVBP Model, the first payment adjustment applies in CY
2018 based on PY1 (2016) data and the final payment adjustment will
apply in CY 2022 based on PY5 (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 CY 2017 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 $378 million (81 FR 76795). We do not
believe the changes finalized in this rule would affect the prior
estimates.
3. Home Infusion Therapy
a. Health and Safety Standards
Section 5012 of the Cures Act (Pub. L. 114-255), which amended
section 1861(s)(2) of the Social Security Act (the Act), established a
new Medicare home infusion therapy benefit. Section 1861(iii) of the
Act, as added by section 5012 of the Cures Act defines, the Medicare
home infusion therapy benefit and covers professional services
including nursing services, training and education, and remote
monitoring and monitoring services associated with administering
certain infusion drugs in a patient's home. This benefit would ensure
consistency in coverage for home infusion benefits for all Medicare
beneficiaries. Section 1861(iii) of the Act, as added by the Cures Act,
sets forth elements for home infusion therapy suppliers in three areas:
(1) Ensuring that all patients have a plan of care established and
updated by a physician that sets out the care and prescribed infusion
therapy necessary to meet the patient-specific needs; (2) having
procedures to ensure that remote monitoring services associated with
administering infusion drugs in a patient's home are provided; and (3)
having procedures to ensure that patients receive education and
training on the effective use of medications and equipment in the home.
We implement the following requirements for home infusion therapy
suppliers--
Ensure that all patients must have a plan of care
established by a physician that prescribes the type, amount and
duration of infusion therapy services that are furnished. The plan of
care would specify the care and services necessary to meet the patient
specific needs.
Ensure that the plan of care for each patient is
periodically reviewed by the physician.
Ensure that patients have infusion therapy support
services at all times through the provision of professional services,
including nursing services, furnished in accordance with the plan of
care on a 7-day-a-week, 24-hour-a-day schedule.
Provide patient training and education.
Provide remote monitoring and monitoring services for the
provision of home infusion therapy and home infusion drugs.
All home infusion therapy suppliers must provide home
infusion therapy services in accordance with nationally recognized
standards of practice, and in accordance with all applicable state and
federal laws and regulations (including the applicable provisions in
the Federal Food, Drug, and Cosmetic Act).
All current standards established by AOs already address the
requirements set forth in this rule. Furthermore, all existing home
infusion therapy suppliers are already accredited by an existing AO for
home infusion therapy to meet requirements established by private
insurers and Medicare Advantage plans. Therefore, we assume that there
would be no new burden imposed on home infusion therapy suppliers in
order to meet the health and safety standards. Additionally, we assume
that these health and safety provisions would not impose a new burden
on home infusion therapy AOs that are likely to apply to be Medicare
approved AOs for home infusion therapy because their existing standards
would already meet or exceed those that would be established in this
rule.
b. Home Infusion Therapy Payment
We estimate that the net impact of the policies in this rule is
approximately $48 million (not including $12 million in beneficiary
cost-sharing) in increased Medicare payments to home infusion suppliers
in CY 2019. This increase reflects the cost of providing infusion
therapy services to existing Medicare beneficiaries who are receiving
DME home infusion therapy (at a 4-hour rate), as the temporary
transitional payment applies only to existing Medicare eligible home
infusion suppliers (that is, DME suppliers that are enrolled as
pharmacies that provide external infusion pumps and supplies are
considered eligible home infusion suppliers). Prior to the
implementation of the temporary transitional payment, home infusion
suppliers have not been separately paid for providing these services
under the DME benefit. For the temporary transitional payment we do not
anticipate an increase in beneficiaries receiving home infusion therapy
services as referral patterns are not likely to change significantly
due to the inability for other provider types (for example, physicians,
HHAs) to become home infusion therapy suppliers prior to CY 2021 and
given that existing DME suppliers already provide home infusion therapy
services without separate reimbursement.
c. Accreditation of Quality Home Infusion Therapy Suppliers
The requirement for accreditation of home infusion therapy
suppliers will
[[Page 56596]]
cause both the home infusion therapy AOs and the home infusion therapy
suppliers to incur costs related to the accreditation process. This
section provides a discussion of the estimated time and cost burdens
that home infusion therapy suppliers may incur as part of the
accreditation process. It also discusses the estimated time and cost
burdens that may be incurred by the home infusion therapy AOs to comply
with the home infusion therapy AO approval and oversight regulations at
Sec. Sec. 488.1010 through 488.1050. As the following discussion
demonstrates, we have estimated that each home infusion therapy AO
would incur an estimated cost burden in the amount of $23,258 for
compliance with the home infusion therapy AO approval and oversight
regulations at Sec. Sec. 488.1010 through 488.1050.
(1) Burden Incurred by Home Infusion Therapy AOs
Section 1834(u)(5)(B) of the Act requires the Secretary to
designate AOs to accredit suppliers furnishing home infusion therapy
not later than January 1, 2021. To date, we have not solicited nor
approved any AOs to accredit home infusion therapy suppliers as
required by section 1834(u)(5)(B) of the Act.
The AOs that respond to the solicitation notice would be required
to submit an application to CMS requesting CMS-approval of a home
infusion therapy accreditation program for Medicare. If CMS approves
the AOs application, the home infusion therapy AO would also be
required to meet, on an ongoing basis, the requirements set forth
iSec. Sec. 488.1010 through 488.1050. The following is a discussion of
the burden associated with specific sections of the home infusion
therapy AO approval and oversight regulations at Sec. Sec. 488.1010
through 488.1050.
(a) Burden for Home Infusion Therapy AOs Associated With Sec. 488.1010
The AOs that accredit home infusion therapy suppliers would incur
time and costs burdens associated with the preparation of the
application they submit to CMS requesting approval of their home
infusion therapy accreditation program. This would include the
preparation, gathering or obtaining of all the documentation required
in Sec. 488.1010(a)(1) through (24).
If the AO has never submitted an application to CMS, we estimate
that it would take approximately 70 hours of time to gather, obtain or
prepare all documentation required by Sec. 488.1010(a)(1) through
(23). However, for an existing AO that has previously submitted an
application to CMS for any type of accreditation program, we estimate
that it would take approximately 45 hours to gather, obtain or prepare
all required documentation. We believe that it would take less time for
an AO that has previously submitted an application to CMS to prepare an
application requesting approval of a home infusion therapy
accreditation program because this AO would already be familiar with
the application process and requirements. The application requirements
for home infusion therapy AOs, set forth at Sec. 488.1010(a)(1)
through (23), are consistent with those for Medicare-certified
providers and suppliers which are set forth at Sec. 488.5.
The home infusion therapy AO would incur costs associated with the
preparation and submission of the home infusion therapy accreditation
program application. The home infusion therapy AO would incur costs for
the wages of all AO staff that work on the preparation of the
application. We estimate that the AO would have 2 staff work on the
preparation of the application. We believe that the AO staff that works
on the AOs application would be clinicians such as registered nurses or
medical or health services manager. According to the U.S. Bureau of
Labor Statistics, the mean hourly wage for a registered nurse is $35.36
(https://www.bls.gov/oes/current/oes291141.htm) and the mean hourly
wage for a medical or health services manager is $53.69 (https://www.bls.gov/oes/current/oes119111.htm). Therefore, we estimate that the
home infusion therapy AO would incur wages for 45 hours of time by a
registered nurse and wages for 45 hours of time by a medical or health
services manager in the amount of $8,014.50 (45 hours x $35.36 per hour
= $1,591.20) + (45 hours x $53.69 = $2,416.05 per hour) + ($4,007.25
for fringe benefits and overhead).
As stated previously, we estimate that it would take approximately
70 hours for an AO that has never submitted an application before to
prepare and submit their home infusion therapy accreditation program
application to CMS. We estimate that the home infusion therapy AO would
incur wages for 70 hours of time by a registered nurse and 70 hours of
time by a medical or health services manager in the amount of $12,453
(70 hours x $35.36 per hour = $2,475.20) + (70 hours x $53.59 =
$3,751.30) + ($6,226,50 for fringe benefits and overhead).
In addition, AOs are required to submit 2 hard copies of their
application to CMS in notebooks with dividers and an electronic copy of
their application on a thumb drive. Because of this requirement, the
home infusion therapy AO would incur costs for the notebooks, dividers,
thumb drive, photocopying, paper and ink, and postage costs for mailing
the notebooks with the hard copies of the application to the CMS
Central Office. We estimate that these costs would be no more than
$250.
At this time, there are five HHA AOs that accredit home infusion
therapy suppliers as part of the deeming accreditation of a home health
accreditation program (that is, The Joint Commission (TJC),
Accreditation Commission for Health Care (ACHC), The Compliance Team
(TCT), Community Health Accreditation Partner (CHAP), Healthcare
Quality Association on Accreditation (HQAA)). The other three home
infusion therapy AOs are pharmacy associations that provide non-
Medicare approved accreditation to home infusion therapy suppliers.
(That is, the National Association of Boards of Pharmacy, the Center
for Pharmacy Practice Accreditation (CPPA) and URAC). The home infusion
therapy accreditation programs offers by these 8 AO have not been
approved under the requirements of section 1834(u)(5)(A) of the Act.
Therefore, in order for the home infusion therapy suppliers accredited
by these AOs to continue to receive payment for the home infusion
therapy services furnished to Medicare beneficiaries, these AOs must
obtain Medicare approval for a home infusion therapy accreditation
program. If all of these eight AOs were to submit applications to CMS
for approval of a home infusion therapy accreditation program, the cost
incurred across all of these potential home infusion therapy AOs for
the preparation and submission of their applications would be $64,116
($4,007.25 x 8 AOs = $32,058) + ($32,058 for fringe benefits and
overhead).
To obtain this CMS approval, these AOs would be required to submit
an application to CMS seeking approval of a home infusion therapy
accreditation program that meets the requirements set forth in the new
home infusion therapy AO approval and oversight regulations set forth
at Sec. 488.1010(a)(1) through (a)(24) and the new home infusion
therapy health and safety regulations at 42 CFR part 466, subpart I. We
have further that the home infusion therapy accreditation programs
submitted to CMS for approval by the existing home infusion therapy AOs
be consistent with the requirements of section 5102 of the 21st Century
CURES Act and section 1861(iii) of the Act. We would also require that
the home infusion therapy
[[Page 56597]]
programs submitted by these AOs be separate and distinct from the AOs
home health deeming accreditation program.
The AOs that currently provide home infusion therapy accreditation
would incur the time and costs associated with the preparation of the
CMS application and required supporting documentation. We estimate that
it would take these AOs approximately 45 hours to prepare their
applications and supporting documentation because they have previously
submitted applications for approval of their home health accreditation
programs. The existing AOs that accredit home infusion therapy
suppliers would also incur costs for the wages for all AO staff
involved with the preparation and submission of the application. The AO
would also incur costs for printing the hard copies of the application,
ink and paper, notebooks and dividers, and postage.
(b) Burden for Home Infusion Therapy AOs Associated With Sec. 488.1030
In accordance with Sec. 488.1030(b) CMS would perform a
comparability review if CMS makes changes to the home infusion therapy
AO approval and oversight regulations or home infusion therapy health
and safety regulation. The purpose of the comparability review is to
allow CMS to assess the equivalency of a home infusion therapy AO's
accreditation standards with the comparable Medicare home infusion
therapy accreditation requirements after CMS imposes new or revised
Medicare home infusion therapy accreditation requirements.
Section 488.1030(b)(1) would provide that if CMS were to make
changes to the home infusion therapy AO approval and oversight
accreditation regulations or the home infusion therapy health and
safety regulations, CMS would send a written notice of the changes to
the home infusion therapy AOs. Section 488.1030(b)(2) would provide
that CMS would provide a deadline of not less than 30 day by which the
AO must submit its revised home infusion therapy accreditation program
standards to CMS.
Section 488.1030(b)(2) would require the home infusion therapy AOs
to revise their home infusion therapy accreditation standards so as to
incorporate the changes made by CMS. The AO must submit their revised
home infusion therapy accreditation program standards to CMS by the
deadline specified in CMS' written notice. The AO may submit a request
for an extension of the submission deadline, so long as the request is
submitted prior to the original submission deadline.
The home infusion therapy AOs would incur a time burden associated
with the time required for the AO staff to review CMS' notice of the
revisions to the home infusion therapy AO approval and oversight
accreditation standards or home infusion therapy health and safety
standards. We estimate that it would take no more than 1 hour for the
AO to review the notice from CMS notifying the AO of the changes to the
AO approval and oversight regulations or health and safety regulation.
The home infusion therapy AOs would incur a cost burden for the
wages of the AO staff that are involved with reviewing the CMS notice
and the preparation of the home infusion therapy AO's revised
accreditation program standards. We believe that the AO staff that
would review the notice from CMS regarding changes to the CMS home
infusion therapy regulations would be clinicians such as registered
nurses. According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a non-industry specific registered nurse is $35.36
(https://www.bls.gov/oes/current/oes291141.htm). Therefore, the home
infusion therapy AO would incur a cost burden in the amount of $70.72
for the preparation of the response to CMS (1 hour x $35.36 per hour =
$35.36) + ($35.36 for fringe benefits and overhead).
The home infusion therapy would also incur a cost burden for the
wages of the AO staff for the time spent preparing the AOs revised home
infusion therapy accreditation standards. There is uncertainty around
our estimate of this cost because the amount of wages incurred would be
dependent on the amount of time spent by the AO staff preparing the AOs
revised accreditation standards.
We believe that the AO staff that would prepare the home infusion
therapy AOs revised home infusion therapy accreditation standards would
be a clinician such as registered nurses. According to the U.S. Bureau
of Labor Statistics, the mean hourly wage for a non-industry specific
registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). If we were to estimate that it would take 5 hours for
the home infusion therapy AO to prepare the revised home infusion
therapy accreditation standards, the estimated cost burden to the AO
would be $353.60 (5 hours x $35.36 per hour = $176.80) + ($176.80 for
fringe benefits and overhead).
At this time, there are five HHA AOs that accredit home infusion
therapy suppliers as part of the deeming accreditation of a home health
accreditation program (that is, The Joint Commission (TJC),
Accreditation Commission for Health Care (ACHC), The Compliance Team
(TCT), Community Health Accreditation Partner (CHAP), Healthcare
Quality Association on Accreditation (HQAA)). The other three home
infusion therapy AOs are pharmacy associations that provide non-
Medicare approved accreditation to home infusion therapy suppliers
(that is, the National Association of Boards of Pharmacy, the Center
for Pharmacy Practice Accreditation (CPPA) and URAC). The home infusion
therapy accreditation programs offers by these 8 AO have not been
approved under the requirements of section 1834(u)(5)(A) of the Act. If
all of these eight AOs were to submit applications to CMS for approval
of a home infusion therapy accreditation program, the cost incurred
across all of these AOs for the preparation of revised accreditation
standards would be $2,828.80 ($176.80 x 8 AOs = $1,414.40) + ($1,414.40
for fringe benefits and overhead). As provided by Sec. 488.1030(b)(4),
a home infusion therapy AO may request an extension of the deadline by
which they must submit their revised accreditation home infusion
therapy standards, so long as the extension request is submitted prior
to the submission deadline. If the home infusion therapy AO requested
an extension of the submission deadline, the AO would incur burden for
the time required to prepare and submit the deadline extension request,
however, we believe this burden would be minimal. We believe that the
extension request could be sent in the form of an email to CMS, would
consist of no more than a few paragraphs and would take no more than 15
minutes to prepare and send.
The AO would incur a cost burden for the wages for the AO staff who
prepares the extension request. We believe that this email would be
sent by an administrative assistant. According to the U.S. Bureau of
Labor Statistics, the mean hourly wage for an executive administrative
assistant is $28.56 (https://www.bls.gov/oes/current/oes436011.htm). We
estimate that the AO would incur a cost burden for wages related to the
preparation and sending of the extension request to CMS in the amount
of $14.28. ($28.56 x 15 minutes = $7.14) + ($7.14 for fringe benefits
and overhead).
At this time, there are eight AOs that accredit home infusion
therapy suppliers (that is--The Joint Commission (TJC), Accreditation
Commission for Health Care (ACHC), The Compliance Team (TCT),
[[Page 56598]]
Community Health Accreditation Partner (CHAP), Healthcare Quality
Association on Accreditation (HQAA), National Association of Boards of
Pharmacy), the Center for Pharmacy Practice Accreditation (CPPA) and
URAC. If all of these eight AOs were to submit applications to CMS for
approval of a home infusion therapy accreditation program, they could
become CMS-approved home infusion therapy AOs. It is unlikely that all
of the AOs would submit a request for an extension of the deadline to
submit their revised accreditation standards to CMS. However, if this
were to occur, the cost incurred across all of these AOs for the
preparation of the extension requests by each home infusion therapy AO
would be $114.24 ($7.14 x 8 AOs = $57.12) + ($57.12 for fringe benefits
and overhead).
Section Sec. 488.1030(b)(7) would provide that if CMS were to make
significant substantial changes to the home infusion therapy AO
approval and oversight accreditation standards or the home infusion
therapy health and safety standards, we may require the home infusion
therapy AOs to submit a new application for approval of their revised
home infusion therapy accreditation programs. If this were to occur,
the home infusion therapy AOs would incur a time burden for the time
associated the preparation of the AOs new application.
We estimate that it would take the home infusion therapy AO
approximately 45 hours to prepare and submit their new application to
CMS. This would include the time and costs required to gather and
prepare the required supporting documentation to go with the
application. We believe that the home infusion therapy AOs would
already be familiar with the CMS application process and would be able
to use their previous application and supporting documentation with
updates, therefore, the reapplication process would be less burdensome.
The home infusion therapy AO would also incur costs associated with
the preparation and submission of a new application. The home infusion
therapy AO would incur costs for the wages of all AO staff that work on
the preparation of the application. We estimate that the AO would have
2 staff persons work on the preparation of the application.
Furthermore, we believe that the AO staff that works on the AOs
application would be clinicians such as a registered nurse and a
medical or health services manager. According to the U.S. Bureau of
Labor Statistics, the mean hourly wage for a non-industry specific
registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm) and the mean hourly wage for a medical or health
services manager is $53.69 (https://www.bls.gov/oes/current/oes119111.htm). Therefore, we estimate that the home infusion therapy
AO would incur wages for 45 hours of time by a registered nurse and 45
hours of time by a medical or health services manager in the amount of
$8,014.50 (45 hours x $35.36 per hour = $1,591.20) + (45 hours x $53.69
= $2,416.05 per hour) + ($4,007.25 for fringe benefits and overhead).
The cost across all the 6 potential home infusion therapy AOs would be
$48,087 ($4,007.25 x 6 AOs = $24,043.50) + ($24,043.50 for fringe
benefits and overhead).
In addition, AOs are required to submit 2 hard copies of their
application to CMS in notebooks with dividers and an electronic copy of
their application on a thumb drive. Because of this requirement, the
home infusion therapy AO would incur costs for the notebooks, dividers,
thumb drive, photocopying, paper and ink, and postage costs for mailing
the notebooks with the hard copies of the application to the CMS
Central Office. We estimate that these costs would be no more than
$250.
In accordance with Sec. 488.1030(c), CMS will perform a standards
review when the home infusion therapy AO makes updates to its
accreditation standards and surveys processes. Section 488.1030(c)(1)
would require that when a home infusion therapy AO proposed to adopt
new or revised accreditation standards, requirements or changes in its
survey process, the home infusion therapy AO must submit its revised
accreditation standards and survey processes to CMS for review, at
least 60 days prior to the implementation date of the revised
standards. Section 488.1030(c)(3) would require that the home infusion
therapy AO provide CMS with a detailed description of the changes that
are to be made to the AO's home infusion therapy accreditation
standards, requirements and survey processes and a detailed crosswalk
(in table format) that states the exact language of the organization's
revised accreditation requirements and the applicable Medicare
requirements for each. Section 488.1030(c)(4) would provide that CMS
must provide a written notice to the home infusion therapy accrediting
organization which states whether the home infusion therapy
accreditation program, including the revisions, continues or does not
continue to meet or exceed all applicable Medicare home infusion
therapy requirements within 60 days of receipt of the home infusion
therapy accrediting organization's changes. Section 488.1030(c)(5)
would provide that if a home infusion therapy AO implements changes
that have neither been determined nor deemed by CMS to be comparable to
the applicable Medicare home infusion therapy requirements, CMS may
open a home infusion therapy accreditation program review in accordance
with Sec. 488.1030(c) or (d).
The burden to the home infusion therapy AO associated with the
standards review includes the time required for the home infusion
therapy AO to prepare its revised accreditation standards and detailed
crosswalk for submission to CMS and submit them to CMS for review. This
burden would also include the time required for the AO staff to read
and respond to CMS' written response. It is important to note that we
do not include in our burden estimate the time that would be spent by
the home infusion therapy AO in making voluntary revisions to their
accreditation standards that are not required by CMS nor prompted by a
regulatory change.
The home infusion therapy AO would also incur costs for the wages
of the AO staff involved with the preparation of the AO's revised home
infusion therapy accreditation standards and the detailed crosswalk for
submission to CMS. The AO would also incur costs for wages for the time
the AO staff spent reviewing CMS' response. However, the AO could send
their revised accreditation standards to CMS via email, therefore the
AO would not incur costs for postage.
We are not able to accurately estimate the total time and cost
burden associated with the standards review because the time required
for the home infusion therapy AO to prepare its revised home infusion
therapy accreditation standards and detailed crosswalk would depend on
the extent of the revision the AO has made to its home infusion therapy
accreditation standards or survey processes. The burden would also
depend of the content and length of CMS' response letter. However, we
do estimate that the preparation of the home infusion therapy AOs
revised accreditation standard and detailed crosswalk for submission to
CMS would take no less than 5 hours.
We believe that the AO staff that would prepare the home infusion
therapy AOs revised home infusion therapy accreditation standards and
detailed crosswalk for submission to CMS would be clinicians such as
registered nurses. According to the U.S.
[[Page 56599]]
Bureau of Labor Statistics, the mean hourly wage for a non-industry
specific registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, if we were to estimate that this task would
take 5 hours to complete, the cost burden to the home infusion therapy
would be $353.60 (5 hours x $35.36 per hour = $176.80) + ($176.80 for
fringe benefits and overhead).
We further estimate that it would take the home infusion therapy AO
approximately 30 minutes for the home infusion therapy AO to review the
CMS response to their submission of the revised home infusion therapy
accreditation standards and detailed crosswalk. We believe that a
clinician such as a registered nurse would review the CMS response
letter. Therefore, the cost burden to the home infusion therapy AO
associated with this task would be $53.04 (45 minutes x $35.36 per hour
= $26.52) + ($26.52 for fringe benefits and overhead).
It is important to note that we have not calculated this burden
across all of the potential home infusion therapy AOs. We have not done
so because the submission of revised home infusion therapy
accreditation standards by a home infusion therapy AO would only occur
on an occasional basis and would never be done by all 6 potential AOs
at the same time.
In accordance with Sec. 488.1030(d), CMS may perform a home
infusion therapy accreditation program review if a comparability,
performance, or standards review reveals evidence of substantial non-
compliance of a home infusion therapy AO's CMS-approved home infusion
therapy accreditation program with the requirements of the home
infusion therapy AO approval and oversight regulation at 42 CFR part
488, subpart L. If a home infusion therapy accreditation program review
is initiated, CMS will provide written notice to the home infusion
therapy AO indicating that its CMS-approved accreditation program
approval may be in jeopardy and that a home infusion therapy
accreditation program review is being initiated. The notice would
provide all of the following information:
A statement of the instances, rates or patterns of non-
compliance identified, as well as other related information, if
applicable.
A description of the process to be followed during the
review, including a description of the opportunities for the home
infusion therapy accrediting organization to offer factual information
related to CMS' findings.
A description of the possible actions that may be imposed
by CMS based on the findings of the home infusion therapy accreditation
program review.
The actions the home infusion therapy accrediting
organization must take to address the identified deficiencies.
A timeline for implementation of the home infusion therapy
accrediting organization's corrective action plan, not to exceed 180
calendar days after receipt of the notice that CMS is initiating a home
infusion therapy accreditation program review.
Section 488.1030(d)(3) would provide that CMS will monitor the
performance of the AO's home infusion therapy and the implementation of
the corrective action plan during a probation period of up to 180 days.
Section 488.1030(d)(4) would provide that if CMS determines, as a
result of the home infusion therapy accreditation program review or a
review of an application for renewal of the accrediting organizations
existing CMS-approved home infusion therapy accreditation program, that
the home infusion therapy accrediting organization has failed to meet
any of the requirements of the regulations at Sec. Sec. 488.1010
through 488.1050, CMS may place the home infusion therapy AO's CMS-
approved home infusion therapy accreditation program on an additional
probation period of up to 180 calendar days subsequent to the period
described in Sec. 488.1030(d)(1)(iv).
The time burden associated with the home infusion therapy
accreditation program review includes the time burden associated with
the AO's review of CMS' written notice which indicates that the home
infusion therapy AO's CMS-approved accreditation program approval may
be in jeopardy and that a home infusion therapy accreditation program
review is being initiated. The time required for the review of the CMS
letter will depend on the length of CMS' finding. However, we estimate
it would take no more than 60 minutes to review this letter.
The AO would incur costs for the wages of the AO staff who performs
the review of the CMS letter. We believe that an AO staff person with a
clinical background such as a registered nurse would review the CMS
letter. According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, we estimate that the cost burden to
the home infusion therapy AO associated with the review of the CMS
letter would be approximately $70.72 (1 hour x $35.36 = $35.36) +
($35.36 for fringe benefits and overhead).
There is further burden associated with the requirement that the AO
prepare and submit a written response to the CMS letter and a
corrective action plan. However, we are unable to accurately estimate
the time burden associated with this task because the amount of time
required for the home infusion therapy AO to prepare the response
letter and corrective plan would be dependent on the number and type of
findings identified in CMS' letter.
However, we believe that an AO staff person with a clinical
background such as a registered nurse would prepare the home infusion
therapy AO's written response to the CMS letter and a corrective action
plan. According to the U.S. Bureau of Labor Statistics, the mean hourly
wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). If we were to estimate that it would take the home
infusion therapy AO 3 hours to prepare and submit a written response to
the CMS letter and a corrective action plan, the estimated cost burden
to the home infusion therapy AO associated with this task would be
$212.16 (3 hours x $35.36 = $106.08) + ($106.08 for fringe benefits and
overhead). Section 488.1030(d)(2) provides that CMS would review and
approve the AO's plan of correction within 30 days of receipt. If CMS
requires the home infusion therapy AO to make changes to their
corrective action plan as a condition of approval, the AO would incur
burden for the time required to make the required revisions to their
plan of correction and resubmit it to CMS.
The home infusion therapy AO would incur a time burden for the time
spent by the AO staff making corrections to the AOs corrective action
plan. We are unable to accurately estimate how long it would take for
the AO to revise its corrective action plan because the revision to be
made to the corrective action plan would be dependent on the extent of
the correction requested by CMS.
However, we believe that an AO staff person with a clinical
background such as a registered nurse would make the corrections to the
AOs corrective action plan. According to the U.S. Bureau of Labor
Statistics, the mean hourly wage for a registered nurse is $35.36
(https://www.bls.gov/oes/current/oes291141.htm). So, if we were to
estimate that it would take the home infusion therapy AO 2 hours to
prepare and submit a written response to the CMS letter and make any
necessary revision to the corrective action plan, the estimated cost
burden to the home
[[Page 56600]]
infusion therapy AO associated with this task would be $141.44 (2 hours
x $35.36 per hour = $70.72) + ($70.72 for fringe benefits and
overhead). During the 180 day probationary period, CMS is likely to
require the home infusion therapy AO to submit periodic progress
reports and participate in periodic telephone to monitor the home
infusion therapy AOs progress. The home infusion therapy AO would incur
burden for the time required to prepare and submit an initial progress
report. We estimate that the initial progress report would take
approximately one hour to prepare. We further estimate that the burden
associated with the preparation and submission of subsequent progress
reports would be less than that for the initial progress report because
the AO would be able to modify or update their initial or previous
progress report. We estimate that it would take approximately 1 hour
for the AO staff to prepare the initial progress report and 30 minutes
for the AO staff to prepare subsequent progress reports. If CMS were to
require the AO to submit one progress report per month during the
entire 180 day probation period (6 months), the AO would have to submit
1 initial progress report and 5 subsequent progress reports. Therefore,
we estimate that the AO would incur a time burden in the amount of 3.5
hours for the submission of all progress reports during the 180 day
probation period. The AO would also incur a cost burden for the wages
of the AO staff person who is involved in the preparation and
submission of the progress reports. We believe that the initial and
subsequent progress reports would be prepared by person with a clinical
background such as a registered nurse. According to the U.S. Bureau of
Labor Statistics, the mean hourly wage for a registered nurse is $35.36
(https://www.bls.gov/oes/current/oes291141.htm). We estimate that the
home infusion therapy AO would incur a cost burden in the amount of
$247.52 for the preparation of the progress reports during the 180 day
probation period (3.5 hours x $35.36 per hour = $123.76) + ($123.76 for
fringe benefits and overhead).
The home infusion therapy AO would also incur burden associated
with the time required to participate in the periodic phone calls with
CMS. We are not able to accurately estimate the amount of time that
would be required for these periodic phone calls because we do not know
how often the AO would be required to participate in phone calls with
CMS or how long these phone calls would last. However, we do not
believe that these phone calls would be held more often that monthly or
last more than one hour. The AO would incur costs for the wages of all
AO staff that participate in the periodic telephone calls. We are not
able to accurately estimate the total cost burden for wages that would
be incurred by the home infusion therapy AO at this time, because we do
not know who from the AO would be attending these meetings.
If we were to estimate that these phone calls were to be held on a
monthly basis during the 180 day probation period for a period of one
hour period per call, the home infusion therapy AO would incur a time
burden in the amount of 6 hours per each staff member that participates
in these phone calls. We believe that the AO would have a minimum of 3
staff that are clinicians, such as registered nurses, participate on
the call. According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/ooh/healthcare/registered-nurses.htm). Therefore, the cost burden to the
home infusion therapy AO for participation in the monthly telephone
calls would be $1,272.96 ((3 AO staff x $35.36 per hour = $106.08 per
call per all staff/$106.08 per call per all staff x 6 calls = $636.48
total wages per all staff per all calls) + ($636.48 for fringe benefits
and overhead)).
At or near the end of the first 180 day probationary period, CMS
will make a decision as to whether the home infusion therapy AO has
successfully come into compliance with the home infusion therapy
regulations, or whether the AO has failed to do so. Section
488.1030(d)(4) would provide that if CMS finds that the home infusion
therapy AO has failed to properly implement the plan of correction and
come into compliance with the requirements of the home infusion therapy
AO approval and oversight regulation or the home infusion therapy
health and safety regulations, CMS may place the home infusion therapy
AO's on an additional probation period of up to 180 calendar days. If
this were to occur, the AO would incur the same or similar time and
cost burdens as in the initial 180 day probationary period. (See
previous estimates for the estimated time and cost burden associated
with the 180-day probationary period).
It is important to note that we have not calculated the burden
associated with the tasks required of the home infusion therapy AO
under Sec. 488.1030(d) across all of the potential home infusion
therapy AOs. We have not done so because the act of CMS placing a home
infusion therapy AO on an accreditation program review would only occur
on a sporadic and as needed basis. There is unlikely to ever be a
situation in which all 8 potential AOs would be under an accreditation
program review at the same time.
(c) Burden for Home Infusion Therapy AOs Associated With Sec. 488.1035
Section 488.1035 titled ``Ongoing responsibilities of a CMS-
approved home infusion therapy accrediting organization'' would require
that the home infusion therapy AO carry out certain activities and
submit certain documents to CMS on an ongoing basis. Section
488.1035(a) would require the home infusion therapy AO to submit the
following documents to CMS: (1) Copies of all home infusion therapy
accreditation surveys, together with any survey-related information
that CMS may require (including corrective action plans and summaries
of findings with respect to unmet CMS requirements); (2) notice of all
accreditation decisions; (3) notice of all complaints related to
providers or suppliers; (4) information about all home infusion therapy
accredited suppliers against which the home infusion therapy
accreditation organization has taken remedial or adverse action,
including revocation, withdrawal, or revision of the providers or
suppliers accreditation; (5) the home infusion therapy accrediting
organization must provide, on an annual basis, summary data specified
by CMS that relate to the past year's accreditation activities and
trends; (6) notice of any changes in the home infusion therapy
accrediting organization's accreditation standards or requirements or
survey process.
We believe that there would be little burden associated with this
requirements for several reasons. First, while the home infusion
therapy AOs would be required to provide copies of all survey reports
and any survey-related information that CMS may require, the AOs would
only be required to provide this information upon request. CMS may not
request the home infusion therapy AO to submit this information if
there are no compliance concerns. Second, we believe the home infusion
therapy AO would keep these records in the normal course of their
business as a home infusion therapy AO and would store the survey
records in electronic format. As the AO already has this information
prepared and stored in an electronic format, it would place little if
any burden on the home infusion therapy AO to provide this information
to CMS. We believe that the AO could send this information to CMS
[[Page 56601]]
via email and attach the survey record electronic files to the email.
We estimate that it would take approximately 30 minutes to locate
the required survey information files and approximately 15 minutes for
the AO staff to prepare an email to CMS and attach the electronic files
to the email. We believe that the person at the AO that would prepare
the email sending the survey information to CMS would most likely be a
clinician such as a registered nurse. According to the U.S. Bureau of
Labor Statistics, the mean hourly wage for a registered nurse is $35.36
(https://www.bls.gov/ooh/healthcare/registered-nurses.htm). Therefore,
the cost burden to the home infusion therapy AO associated with the
preparation and submission of the survey reports and information to CMS
would be $53.04 (30 minutes to locate information requested by CMS x
$35.36 per hour = $17.68) + (15 minutes x $35.36 = $8.84) + ($26.52 for
fringe benefits and overhead). The estimated cost across the potential
8 home infusion therapy AOs for these tasks would be $424.32 ($53.04 x
8 home infusion therapy AOs = $424.32).
Section 488.1035(a)(2) would require the home infusion therapy AO
to provide CMS with notice of all accreditation decisions made for each
home infusion therapy supplier that files an application for
accreditation. This would consist of a list of each home infusion
therapy supplier that had filed an application with the home infusion
therapy AO for accreditation and the accreditation decision made by the
AO.
We believe that these accreditation decisions would be made by the
AO in the normal course of the AOs business of performing accreditation
of home infusion therapy suppliers. We further believe that there would
be little burden associated with the requirement that the AO provide
CMS with a list of the accreditation decisions made by the AO as this
is information that would be readily available to the AO and that could
quickly and easily be provided to CMS via email. We estimate that it
would take approximately 15 minutes for the home infusion AO to gather
the required accreditation decision information in preparation for
sending it to CMS.
We believe that this information can be sent to CMS via email and
estimate that it would take an additional 15 minutes for the AO staff
to prepare an email to CMS and attach the electronic files containing
the accreditation decision information to the email. We believe that
the person at the AO who would prepare the accreditation decision
information and prepare the email to CMS would most likely be a
clinician such as a registered nurse. According to the U.S. Bureau of
Labor Statistics, the mean hourly wage for a registered nurse is $35.36
(https://www.bls.gov/oes/current/oes291141.htm). Therefore, the
estimated cost burden to the home infusion therapy AO associated with
the preparation and submission of the survey reports and information to
CMS would be $35.36 (15 minutes x $35.36 per hour = $8.84) and (15
minutes x $35.36 = $8.84) + ($17.68 for fringe benefits and overhead).
The estimated cost across the potential 8 home infusion therapy AOs for
these tasks would be $282.88 ($35.36 x 8 home infusion therapy AOs =
$282.88).
Section 488.1035(a)(3) would require the AO to report complaint
information to CMS. Complaint information is typically reported to CMS
by other AOs by email on a monthly basis for the previous month. The
contents of the complaint information reported to CMS would depend on
whether the AO had received any complaints during the previous month.
For example, if the AO received no complaint during the previous month,
this email could consist of a sentence stating that the AO had received
no complaints If the AO had received one or more complaints during the
previous month, the AO would be required to provide information about
the nature of each complaint, a description of the investigation
performed, a description of how the complaint was resolved and the date
resolved.
We believe that there would be little burden associated with the
reporting of complaint information by the home infusion therapy AO to
CMS for several reasons. First, we estimate that the home infusion
therapy AOs will rarely receive complaints about their accredited home
infusion therapy suppliers. Second, we believe that the home infusion
therapy AO will store information about any complaints received in an
electronic format. Therefore, complaint information can be reported by
the home infusion therapy AO to CMS via email. We estimate that the
preparation of the complaint information email would take only no more
than 15 minutes to prepare and send.
We believe that the person at the AO who would prepare the
complaint information email and sent it to CMS would most likely be a
clinician such as a registered nurse. According to the U.S. Bureau of
Labor Statistics, the mean hourly wage for a registered nurse is $35.36
(https://www.bls.gov/oes/current/oes291141.htm). Therefore, the
estimated monthly cost burden to the home infusion therapy AO
associated with the submission of complaint information to CMS would be
$17.68 (15 minutes x $35.36 per hour = $8.84) + ($8.84 for fringe
benefits and overhead). The estimated yearly burden to the home
infusion therapy AO for this task would be $212.16 ($17.68 per month x
12 months per year = $212.16 per year).
The estimated monthly cost across the potential 8 home infusion
therapy AOs for these tasks would be $141.44 ($17.68 x 8 home infusion
therapy AOs = $141.44). The estimated yearly cost across the 6
potential home infusion therapy AOs would be $1,697.28 ($17.68 x 8 AOs
= $141.44 per all AOs per month and $141.44 per year x 12 months per
year = $1,697.28). Section 488.1035(a)(4) would require the AO to
provide CMS with information about all home infusion therapy accredited
suppliers against which the home infusion therapy AO has taken remedial
or adverse action, including revocation, withdrawal, or revision of the
providers or suppliers accreditation. The information to be sent to CMS
would simply consist of a list of the home infusion therapy suppliers
and the type of remedial or adverse action taken.
We expect that when a home infusion therapy AO takes remedial or
adverse action against its accredited supplier, the AO would prepare
documentation which states the action taken and the reason this action
was taken. We further believe that the AO would store this information
electronically. This would enable the AO to send the required
information to CMS via email. Therefore, we believe that there would be
little burden associated with this requirement.
We believe that the home infusion therapy AOs could send
information about adverse or remedial actions they have taken against
their accredited suppliers via email. We estimate that it would take
approximately 30 minutes for a home infusion therapy AO to prepare a
report about the adverse or remedial actions taken against its
accredited suppliers and approximately 15 minutes to prepare an email
to CMS, attach the electronic file with the required information and
send it to CMS. The home infusion therapy AOs would be required to
report this information to CMS on a monthly basis.
The AO would incur a cost burden for the wages of the AO staff for
the time spent preparing the report of the adverse or remedial action
taken against the AO's accredited home infusion therapy suppliers and
the time spent preparing
[[Page 56602]]
the email to CMS. We believe that the person at the AO who would
prepare the report of adverse or remedial action taken and prepare the
email to CMS would most likely be a clinician such as a registered
nurse. According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost monthly cost
burden to the home infusion therapy AO associated with the submission
of information about the adverse or remedial action taken by the home
infusion therapy AO against its accredited home infusion therapy
suppliers to CMS would be $53.04 (30 minutes x $35.36 per hour = $17.68
+ (15 minutes x $35.36 per hour = $8.84) + ($26.52 for fringe benefits
and overhead). The estimated yearly cost burden to the home infusion
therapy AO for this task would be $636.48 ($53.04 per month x 12 months
per year = $636.48 per year).
The estimated monthly cost across the potential 8 home infusion
therapy AOs for these tasks would be $424.32 ($53.04 x 8 home infusion
therapy AOs = $424.32). The estimated yearly cost across the 8
potential home infusion therapy AOs would be $5,091.84 ($53.04 x 8 AOs
= $424.32 per all AOs per month and $424.32 per year x 12 months per
year = $5,091.84).
Section 488.1035(a)(5) would require the home infusion therapy
accrediting organization to provide, on an annual basis, summary data
specified by CMS that relates to the past year's accreditation
activities and trends. This summary data might include information such
as the total number of complaints received during the year, the total
number of immediate jeopardy situations found during the year, and the
total number of deficiencies cited. We believe this is information that
the AO would collect and document throughout the year in the normal
course of business. We further believe that the home infusion therapy
AO would prepare this year end summary data for their own
informational, quality improvement, and research purposes.
We believe that there would be little, if any time burden
associated with the submission of the documents and information
required by Sec. 488.1035(a)(5) by the home infusion therapy AOs to
CMS, because these are documents which the AO would keep in the normal
course of business, therefore these documents would be easily
accessible to the home infusion therapy AO. Title 5 CFR 1320.3(b)(2)
states that the time, effort, and financial resources necessary to
comply with a collection of information that would be incurred in the
normal course of their activities (for example in compiling and
maintaining business records) will be excluded from the burden if the
agency demonstrates that the reporting, recordkeeping, or disclosure
activities needed to comply are usual and customary. Further, we
believe that most, if not all of the home infusion therapy AOs would
store these documents electronically and would be able to send them
electronically to CMS via email.
The home infusion therapy AO would incur a time burden for the
preparation and submission of the annual summary data to CMS. We
estimate that it would take approximately 60 minutes for the home
infusion therapy AO to locate the required annual summary data
information and prepare it for submission to CMS. We further estimate
that it would take an additional 15 minutes to prepare an email to CMS
and attach the electronic files containing the summary data.
The home infusion therapy AO would incur a cost burden for the
wages of the AO staff who prepares that summary data for submission to
CMS and prepares the email to in which the annual summary data are
submitted to CMS. We believe that the person at the AO who would
prepare the summary data for submission to CMS and also prepare the
email to CMS would most likely be a clinician such as a registered
nurse. According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the
home infusion therapy AO associated with the submission of summary data
to CMS would be $88.40 (60 minutes x $35.36 per hour = $35.36) + (15
minutes x $35.36 per hour = $8.84) + ($44.20 for fringe benefits and
overhead). The estimate cost burden across the 8 potential home
infusion therapy AOs for this task would be $707.20 ($88.40 x 8
potential home infusion therapy AOs = $707.20).
Section 488.1035(b) would require that within 30 calendar days
after a change in CMS requirements, the home infusion therapy
accrediting organization must submit an acknowledgment of receipt of
CMS' notification to CMS. The time burden associated with this
requirement would be the time required for an AO staff person to review
the notification from CMS about the change in home infusion therapy
accreditation program requirements and the time required for the AO
staff person to compose and send an acknowledgement email to CMS.
We estimate the time required for the AO staff to review the notice
of a change in CMS requirements would be 1 hour. We further estimate
that the time that would be required to prepare and submit the
acknowledgement of receipt of the CMS notice would be approximately 15
minutes because this notice could be sent to CMS via email and would
only consist of 1-2 paragraphs.
The home infusion therapy AO would incur a cost burden for the
wages of the staff for the time required to review the notice from CMS
of the change in CMS requirements. The home infusion therapy AO would
incur a cost burden for the wages of the staff for the time required to
prepare the acknowledgement and submits it to CMS. We believe that the
person at the AO who would prepare the email to CMS acknowledging
receipt of the CMS notice would most likely be a clinician such as a
registered nurse. According to the U.S. Bureau of Labor Statistics, the
mean hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm).
The estimated cost burden to the home infusion therapy AO
associated with the review of the notice from CMS of changes to the CMS
requirements would be $70.72 (1 hour x $35.36 per hour) + ($35.36 for
fringe benefits and overhead). The estimated cost burden associated
with the preparation and submission of the acknowledgement by the home
infusion therapy AO would be $17.68 (15 minutes x $35.36 per hour =
$8.84) + ($8.84 for fringe benefits and overhead). The estimates cost
across the 8 potential home infusion therapy AOs would be $707.20
($70.72 x 8 = $565.76) + ($17.68 x 8 = $141.44).
It is important to note that the home infusion therapy AOs would
only have to perform these tasks if CMS were to make a change to the
home infusion therapy standards. We believe that this would occur on an
infrequent basis, therefore, the home infusion therapy AOs would incur
these time and cost burdens on an infrequent basis.
Section 488.1035(c) would require that the home infusion therapy AO
permit its surveyors to serve as witnesses if CMS takes an adverse
action based on accreditation findings. An example in which a surveyor
would be needed to testify as a witness would be if there was
litigation about CMS' termination of a home infusion therapy supplier's
participation in the Medicare program and the surveyor that had
performed a survey of that home infusion therapy supplier was needed to
[[Page 56603]]
testify about the survey findings. The burden associated with this
requirement would be the time the surveyor spent providing testimony,
any travel expenses the home infusion therapy AO would be responsible
to pay, and the wages paid to the surveyor during the time spent giving
testimony.
The home infusion therapy AO would incur a time burden for the time
required for the AO's surveyor to serve as a witness. This would
include travel time to and from the location where the hearing is being
held. The AO would also incur cost burdens for the wages paid to the
surveyor during the time they are serving as a witness and also for any
travel expenses the AO may be required to pay, that are not reimbursed.
It is important to note that the home infusion therapy AO surveyors
would rarely, if ever, be required to act as a witness. Therefore, this
is a burden that the home infusion therapy AOs would not be likely to
incur.
Section 488.1035(d) would require that, within 2 business days of
identifying a deficiency of an accredited home infusion therapy
supplier that poses immediate jeopardy to a beneficiary or to the
general public, the home infusion therapy AO must provide CMS with
written notice of the deficiency and any adverse action implemented by
the AO. The burden associated with this requirement is the time
required to provide notice to CMS of the immediate jeopardy situation
and the wages for the AO staff person for the time spent preparing and
submitting this notice.
We believe that the AO would keep this information in the normal
course of their business of providing home infusion therapy
accreditation. Therefore, the AO should have these readily available.
We further believe that the home infusion therapy AOs would keep
records related to immediate jeopardy findings in an electronic format.
The AO would incur a time burden for the time required to report
the immediate jeopardy information to CMS. We estimate that it would
take the AO no more than 20 minutes to prepare an email to CMS in which
they provide the required information about the immediate jeopardy
situation that has been discovered. The AO can attach electronic files
to the email that contain the required information. It is important to
note that we do not count, as a burden, the time spent by the home
infusion therapy AO in finding the immediate jeopardy situation or
resolving it, because it is the duty of any CMS-approved AO to monitor
it's accredited providers or supplier to ensure they are providing care
that meets the accreditation standards and that they do not have any
situation that put the patients or general public in imminent danger of
harm. The home infusion therapy AO would incur a cost burden for the
wages of the AO staff that prepares the email to CMS which notified CMS
of the immediate jeopardy situation. We believe that the person at the
AO who would prepare the immediate jeopardy notification email to CMS
would most likely be a clinician such as a registered nurse. According
to the U.S. Bureau of Labor Statistics, the mean hourly wage for a
registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the home
infusion therapy AO associated with the preparation and submission of
the acknowledgement by the home infusion therapy AO would be $23.60
($35.36 divided by 60 minutes per hour = $0.59 per minute/20 minutes x
$0.59 per minute = $11.80) + ($11.80 for fringe benefits and overhead).
The home infusion therapy AOs would have to perform these tasks and
incur these time and costs burdens only if they discover an immediate
jeopardy situation with an accredited home infusion therapy supplier.
We would like to point out that this would not be a regular time and
cost burden that would be incurred by the home infusion therapy AOs, as
the discovery of immediate jeopardy situations by AOs do not occur
frequently.
It is important to note that we have not calculated the burden
associated with the tasks required of the home infusion therapy AO
under Sec. 488.1035(d) across all of the potential home infusion
therapy AOs. We have not done so because the need for a home infusion
therapy AO to report an immediate jeopardy situation to CMS would only
occur on a sporadic basis. Section 488.1035(e) would require that
within 10 calendar days after CMS' notice to a CMS-approved home
infusion therapy AO that CMS intends to withdraw approval of the AO's
home infusion therapy accreditation program, the home infusion therapy
AO must provide written notice of the withdrawal to all of the home
infusion therapy AO's accredited suppliers. The time burden associated
with this requirement would be the time spent by the AO staff to
prepare the required notice that must be sent to all of the AOs
accredited home infusion therapy suppliers and the time required for
the AO to send this notice out to all of its accredited suppliers.
We estimate that it would take that home infusion therapy AO
approximately 45 minutes to prepare the notice that they must send out
to their accredited suppliers. We believe it would take an additional 2
minutes per letter to be sent by the home infusion therapy AO to its
accredited suppliers to prepare these letters for mailing (that is--
fold letter, place in envelope, affix correct amount of postage and
place the letter into the outgoing mail). We are not able to accurately
estimate the amount of time it would take for the AO to send this
notice out to all of its accredited suppliers because this would be
dependent on the number of accredited suppliers the AO has at the time.
However, if were to assume that a home infusion therapy AO had 50
accredited home infusion therapy suppliers, this task would take the AO
staff 1.7 hours to complete (2 minutes x 50 letters = 100 minutes) and
(100 minutes divided by 60 minutes per hour = 1.7 hours).
The home infusion therapy AO would incur a cost burden for the
wages of the AO staff person that prepares the required notification.
We believe that the person at the AO who would prepare the required
notification would most likely be a clinician such as a registered
nurse. According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the
home infusion therapy AO associated with the preparation of the
required notice which is to be sent to all of the AO's accredited
suppliers would be $53.04 (45 minutes x $35.36 per hour = $26.52) +
($26.52 for fringe benefits and overhead).
The home infusion therapy would also incur a cost burden for the
wages of the staff person for the time spent preparing the required
notices for mailing and mailing them. We are unable to accurately
estimate this cost burden because the time required to perform this
task would be dependent on the number of accredited home infusion
therapy supplier the AO has at the time. However, if were to assume
that a home infusion therapy AO had 50 accredited home infusion therapy
suppliers, this task would take the AO staff 1.7 hours to complete (2
minutes x 50 letters = 100 minutes/100 minutes divided by 60 minutes
per hour = 1.7 hours). We believe that the person that would perform
this task would be an Administrative Assistant. According to the U.S.
Bureau of Labor Statistics, the mean hourly wage for an executive
administrative Assistant is $28.56 (https://www.bls.gov/oes/current/oes436011.htm). Therefore, the home infusion therapy AO would incur a
cost burden in the amount of $97.92 for the
[[Page 56604]]
completion of this task ($28.56 per hour divided by 60 minutes per hour
= $0.48 per minute/60 minutes per hour divided by 10 = 6 minutes per
0.1 hour/6 minutes x 7 = 42 minutes = 0.7 hour/60 minutes + 42 minutes
= 102 minutes or 1.7 hours/$0.48 per minute x 102 minutes = $48.96) +
($48.96 for fringe benefits and overhead).The home infusion therapy AO
would incur an additional cost burden for miscellaneous costs. These
costs would include the cost of the paper used to print the notices on,
the printer ink used, the cost of the envelopes used, and the postage
required to mail all the notices. We are unable to accurately estimate
these costs as they are dependent on the number of notices that would
be sent. We believe that these costs would not exceed $250.
It is important to note that the home infusion therapy AO surveyors
would rarely, if ever, be required to perform the tasks required by
Sec. 488.1035(e) because we would rarely withdraw the CMS approval of
a home infusion therapy AO. We would do so if there were serious,
unresolved compliance concerns that the AO was unable or unwilling to
rectify, even after being placed on an accreditation program
probationary period.
(d) Burden for Home Infusion Therapy AOs Related to Sec. 488.1040
Section 488.1040 would require that as part of the application
review process, the ongoing review process, or the continuing oversight
of an home infusion therapy AO's performance, CMS may conduct onsite
inspections of the home infusion therapy AO's operations and offices at
any time to verify the home infusion therapy AO's representations and
to assess the home infusion therapy AO's compliance with its own
policies and procedures. Section 488.1040(b) provides that the
activities to be performed by CMS staff during the onsite inspections
may include, but are not limited to the following: (1) Interviews with
various AO staff; (2) review of documents, survey files, audit tools,
and related records; (3) observation of meetings concerning the home
infusion therapy accreditation process; (4) auditing meetings
concerning the accreditation process; (5) observation of in-progress
surveys and audits; and (6) evaluation of the AO's survey results and
accreditation decision-making process.
We believe that there would be little burden associated with the
onsite visits made by CMS to the home infusion therapy AO's operations
and offices because most of the activities related to the onsite visit
involve work performed by the CMS staff, which would not impose burden
on the AO staff (such as review of records or observation of meeting
held at the AOs offices). We estimate that the time burden to the home
infusion therapy AO associated with these onsite visits would include
the time required for the AO staff to greet the CMS team upon arrival
and show them to the conference room, the time required to locate the
records the CMS team requests for review, and the time required for CMS
to conduct interviews of AO staff members. If the home infusion therapy
AOs records are electronic, an AO staff member may need to remain with
the CMS team during their record review to assist them with access to
the AO's records.
We are not able to accurately estimate the total time that would be
required for these activities because we have not yet accredited any
home infusion therapy AOs, nor have we had an opportunity to perform an
onsite visit to a home infusion therapy AO. We do not yet know what
type of accreditation standards and surveys processes the home infusion
therapy AOs would use. Also, we do not know the amount and type of
records we would seek to review during an onsite visit to a home
infusion therapy AO or approximately how much time we would need to
review these records. Likewise, we do not yet know how much interaction
we would need to have with the home infusion therapy AO staff or which
AO staff members we would choose to interview. The onsite AO visits we
have performed for other types of AOs have lasted 1 to 2 days depending
on the type of AO.
However, if we estimate that it would take 1 hour for the CMS team
entrance conference, 8 hours for the CMS team to perform their records
review and 1 hour for the CMS team conduct the exit conference, the
home infusion therapy AO would incur a time burden in the amount of 1
hour for each AO staff person that attends the entrance conference, 8
hours for any staff that remains with the CMS team to assist them with
the record review and 1 hour of time for each AO staff person that
attends the exit conference. We believe that the AO staff that would be
attending the entrance and exit conferences and assisting the CMS staff
with their records review would most likely be clinicians such as
registered nurses. According to the U.S. Bureau of Labor Statistics,
the mean hourly wage for a non-industry specific registered nurse is
$35.36 (https://www.bls.gov/oes/current/oes291141.htm). We estimate
that approximately 4 AO staff persons would attend the entrance and
exit conferences and that one AO staff person would assist the CMS team
with their record review.
Based on the a previously stated time estimate, we estimate that
the home infusion therapy AO would incur a cost burden in the amount of
$282.88 for wages for four AO staff for attendance at the entrance
conference. ($35.36 per hour per each AO staff x 1 hour = $35.36/$35.36
per hour x 4 AO staff = $141.44) + ($141.44 for fringe benefits and
overhead).
We further estimate that the AO would incur a cost burden in the
amount of $282.88 for the wages of the four AO staff for attendance at
the exit conference. ($35.36 per hour per each AO staff x 1 hour =
$35.36/$35.36 per hour x 4 AO staff = $141.44) + ($141.44 for fringe
benefits and overhead).
We also estimate that the AO would incur a cost burden in the
amount of $565.76 for the wages of the AO staff person that would
remain with the CMS team to assist them with their record review. (8
hours x $35.36 = $282.88) + ($282.88 for fringe benefits and overhead).
The total estimated cost burden to the home infusion therapy AO
associated with the CMS onsite visit is $1,131.52 ($282.88 for entrance
conference + $282.88 for exit conference + $565.76 for assisting CMS
staff with record review = $1,131.52). The estimated cost burden across
all of the potential eight home infusion therapy AOs would be $9,052.16
($1,131.52 x 8 potential AOs = $9,052.16).
In this final rule with comment period, we have the eight AOs that
currently provide accreditation to home infusion therapy suppliers must
submit an application to CMS for approval of a separate and distinct
home infusion therapy accreditation program. A corporate onsite visit
to the home infusion therapy AOs office is a part of the application
review and approval process. Therefore, each of the AOs that submit an
application to CMS for approval of a home infusion therapy program
would incur the previously stated estimated burden related to the
corporate onsite visit. However, after the initial application process
has been completed, CMS would only make additional corporate onsite
visits every 6 years when the home infusion therapy AOs submit their
renewal application. Therefore, this would not be is a frequent or
ongoing burden incurred by the home infusion therapy AOs.
(e) Burden for Home Infusion Therapy AOs Related to Sec. 488.1045
Section Sec. 488.1045 contains regulations related to the
voluntary and involuntary termination of the CMS
[[Page 56605]]
approval of a home infusion therapy AO's home infusion therapy
accreditation program. Section 488.1045(a) would provide that a home
infusion therapy accrediting organization that decides to voluntarily
terminate its CMS-approved home infusion therapy accreditation program
must provide written notice at least 90 days in advance of the
effective date of the termination to CMS and each of its accredited
home infusion therapy suppliers.
The requirement that the home infusion therapy AO provide notice of
its decision to voluntarily terminate its CMS approved home infusion
therapy accreditation program to CMS and all of its accredited home
infusion therapy suppliers would cause the AO to incur the following
time burdens: (1) The time required to prepare and send the required
notice to CMS; and (2) the time required to prepare and send the
required notice to all of the AOs accredited home infusion therapy
suppliers. We would require that the AO send the required notice of
their decision to voluntarily terminate its CMS-approved accreditation
program to CMS by U.S. mail. We would also require the AO to send the
required notice to all of its accredited home infusion therapy
suppliers by U.S. mail. We estimate that it would take approximately 60
minutes for the AO staff person to prepare the letter to CMS in which
the AO notified CMS that the AO wishes to voluntarily terminate its
CMS-approved home infusion therapy accreditation program, print the
letter and mail it.
We further estimate that it would take the AO staff person another
4 hours to perform the following tasks: (1) Draft a letter its
accredited home infusion therapy suppliers, giving notice that the AO
is voluntarily terminating its CMS approved home infusion therapy
accreditation program; (2) perform a mail merge to prepare a copy of
the letter addressed to each accredited home infusion therapy supplier;
(3) print out a letter to each accredited supplier and envelope; put
the letters into the envelopes; (4) affix the correct amount of
postage; and (5) put the envelopes in the outgoing mail. We believe
that the person at the AO who would perform these tasks would most
likely be a clinician such as a registered nurse. According to the U.S.
Bureau of Labor Statistics, the mean hourly wage for a registered nurse
is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore,
the estimated cost burden to the home infusion therapy AO associated
with the preparation of the required notice which is to be sent to all
of the AO's accredited suppliers would be $35.36 (60 minutes x $35.36
per hour = $35.36).
The home infusion therapy AO would also incur a cost burden for the
wages of the staff person for the time spent preparing and mailing the
required notices to be sent to the AO's accredited home infusion
therapy suppliers. As stated previously, we estimate that it would take
approximately 4 hours of time for an AO staff person to prepare the
required notification letter to the AOs accredited providers, print out
a copy of the letter for each accredited home infusion therapy supplier
and put these letters into the mail. We believe that the person at the
AO who would perform these tasks would most likely be a clinician such
as a registered nurse. According to the U.S. Bureau of Labor
Statistics, the mean hourly wage for a registered nurse is $35.36
(https://www.bls.gov/oes/current/oes291141.htm). Therefore, the
estimated cost burden to the home infusion therapy AO associated with
the preparation of the required notice for mailing would be $353.60 (4
hours x $35.36 per hour = $176.80) + ($176.80 for fringe benefits and
overhead).
The home infusion therapy AO would incur an additional burden for
miscellaneous costs associated with the preparation of the required
notices to be sent to CMS and the AOs accredited home infusion therapy
suppliers, including the cost of the paper on which the notices are
printed, the printer ink used, the cost of the envelopes used, and the
postage required to mail all of the notices. We are unable to
accurately estimate these costs as they are dependent on the number of
notices that would need to be sent. However we believe these costs
would not exceed $200. We seek comment on how to estimate this burden.
It is important to note that we have not calculated the burden
associated with the tasks required of the home infusion therapy AO
under Sec. 488.1045 across all of the potential home infusion therapy
AOs. We have not done so because the need for a home infusion therapy
AO to perform these tasks only arise if a home infusion therapy AO
voluntarily decides to terminate its CMS approved home infusion therapy
accreditation program. This would occur rarely, if ever.
Section 488.1045(b) states that once CMS publishes a notice in the
Federal Register announcing the decision to involuntarily terminate the
home infusion therapy AO's home infusion therapy accreditation program,
the home infusion therapy AO must provide written notification to all
suppliers accredited under its CMS-approved home infusion therapy
accreditation program by no later than 30 calendar days after the
notice is published in the Federal Register. This notice would announce
that CMS is withdrawing its approval of the AOs home infusion therapy
accreditation program and the implications for the home infusion
therapy suppliers payment status in accordance with the requirements at
Sec. 488.1010(f) once their current term of accreditation expires.
The time burden associated with Sec. 488.1045(b) would be the time
it takes for the home infusion therapy AO to prepare and send the
required written notification to all accredited home infusion therapy
suppliers which states that CMS is withdrawing the AOs approval of the
home infusion therapy accreditation program and which also states the
implications for the home infusion therapy suppliers payment status. We
estimate that it would take no more than 4 hours for an AO staff person
to perform the following tasks: (1) Draft the required notification
letter; (2) perform a mail merge to prepare a copy of the letter that
is addressed to each home infusion therapy supplier accredited by the
AO; (3) print copies of the notification letters for each of the AOs
accredited home infusion therapy suppliers; (4) put each notifications
letter into an envelope; (5) affix the correct amount of postage to the
envelope and (6) put the envelopes into the outgoing mail.
The home infusion therapy AO would incur a cost burden for the
wages for the AO staff who performs the previously stated tasks. We
believe that the person at the AO who would perform these tasks would
most likely be a clinician such as a registered nurse. According to the
U.S. Bureau of Labor Statistics, the mean hourly wage for a registered
nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm).
Therefore, the estimated cost burden to the home infusion therapy AO
associated with the preparation of the required notice which is to be
sent to all of the AO's accredited suppliers would be $282.88 (4 hours
x $35.36 per hour = $141.44) + ($141.44 for fringe benefits and
overhead).
The home infusion therapy AO would incur an additional burden for
miscellaneous costs associated with the preparation of the required
notices to be sent to the AOs accredited home infusion therapy
suppliers, including the cost of the paper on which the notices are
printed, the printer ink used, the cost of the envelopes used, and the
postage required to mail all of the notices. We believe that these
costs would not exceed $200.
[[Page 56606]]
It is important to note that we have not calculated the burden
associated with the tasks required of the home infusion therapy AO
under Sec. 488.1045 across all of the potential home infusion therapy
AOs. We have not done so because the need for a home infusion therapy
AO to perform these tasks required by Sec. 488.1045(b) would only
arise if CMS decides to involuntarily terminate the CMS approval of the
AO's home infusion therapy accreditation program. This would occur
rarely, if ever.
Section 488.1045(c)(3) would require that for both voluntary and
involuntary terminations of a home infusion therapy AOs CMS approved
home infusion therapy accreditation program, the home infusion therapy
AO must provide a second written notification to all of its accredited
home infusion therapy suppliers ten calendar days prior to the AO's
accreditation program termination effective date. We estimate that the
time and cost burdens associated with this requirement would be the
same as our estimated burden for proposed Sec. 488.1045(b) set forth
previously.
Section 488.1045(d) sets forth the required steps that a home
infusion therapy AO must take when one of its accredited home infusion
therapy suppliers has requested a voluntary withdrawal from
accreditation. The withdrawal from accreditation by the home infusion
therapy supplier may not become effective until the AO completes all of
the following 3 steps: (1) The home infusion therapy AO must contact
the home infusion therapy supplier to seek written confirmation that
the home infusion therapy supplier intends to voluntarily withdraw from
the home infusion therapy accreditation program; (2) the home infusion
therapy AO must advise the home infusion therapy supplier, in writing,
of the statutory requirement for accreditation for all home infusion
therapy suppliers and the possible payment consequences for a lapse in
accreditation status; (3) the home infusion therapy AO must submit
their final notice of the voluntary withdrawal of accreditation by the
home infusion therapy supplier to CMS by no later than 5 business days
after the request for voluntary withdrawal is ultimately processed and
effective.
The burden associated with the requirement that the home infusion
therapy AO contact the home infusion therapy supplier to seek written
confirmation that the home infusion therapy supplier intends to
voluntarily withdraw from the home infusion therapy accreditation
program would include the time required for the AO to contact the home
infusion therapy supplier to request written confirmation that the home
infusion therapy supplier does indeed want to terminate their home
infusion therapy accreditation. We estimate that the AO would most
likely contact the home infusion therapy supplier to make this request
by telephone or email. We estimate this would take no more than 15
minutes.
The AO would incur a cost burden for the wages of the AO staff
person for the time spent contacting the home infusion therapy supplier
to confirm they intend to voluntarily withdraw from the home infusion
therapy accreditation program. We believe that the person at the AO who
would perform this task would most likely be a clinician such as a
registered nurse. According to the U.S. Bureau of Labor Statistics, the
mean hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the
home infusion therapy AO associated with contacting the home infusion
therapy supplier to confirm that they do want to voluntarily terminate
would be $17.68 (15 minutes x $35.36 per hour = $8.84) + ($8.84 for
fringe benefits and overhead).
The home infusion therapy AO would also incur a time burden
associated with the requirement that they send a written notice to the
home infusion therapy supplier that is voluntarily terminating their
home infusion therapy accreditation, which provides notice of the
statutory requirement for accreditation for all home infusion therapy
suppliers and the possible payment consequences for a lapse in
accreditation status. We estimate that it would take the home infusion
therapy no more than 60 minutes to prepare the written notification.
We believe that the person at the AO who would prepare the required
written notice to be sent to the home infusion therapy supplier that is
voluntarily terminating its home infusion therapy accreditation would
most likely be a clinician such as a registered nurse. According to the
U.S. Bureau of Labor Statistics, the mean hourly wage for a registered
nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm).
Therefore, the estimated cost burden to the home infusion therapy AO
associated with the preparation of the required written notice would be
$70.72 (1 hours x $35.36 per hour = $35.36) + ($35.36 for fringe
benefits and overhead). We further estimate that the AO would incur
postage costs in the amount of $0.50 for each letter sent.
Finally, we estimate the burden associated with Sec.
488.1045(d)(3) would include the time required for the home infusion
therapy AO staff to prepare a final notice of voluntary withdrawal of
accreditation by the home infusion therapy supplier and the time
required to send this notice to CMS. We estimate that it would only
take the AO staff 15 minutes or less to prepare the required notice for
CMS, because this notice could be sent to CMS by email. We estimate it
would take an additional 10 minutes of time for the AO staff to prepare
the email and attach the written notice to the email.
The AO would incur a cost burden for the wages of the AO staff for
the time spent preparing the notice and sending it to CMS. We believe
that the person at the AO who would prepare the required written notice
to be sent to CMS would most likely be a clinician such as a registered
nurse. According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the
home infusion therapy AO associated with the preparation of the
required written notice to be sent to CMS would be $29.48 (15 minutes x
$35.36 per hour = $8.84) + (10 minutes x $35.36 per hour = $5.90) +
($14.74 for fringe benefits and overhead).
It is important to note that we have not calculated the burden
associated with the tasks required of the home infusion therapy AO
under Sec. 488.1045(d) across all of the potential home infusion
therapy AOs. We have not done so because the need for a home infusion
therapy AO to perform these tasks would only arise if a home infusion
therapy supplier would decide to voluntarily terminate its
accreditation with the home infusion therapy AO. This would occur on an
infrequent basis. We do not believe that there would ever be a
situation in which all 6 of the potential home infusion therapy AOs
would have a home infusion therapy supplier decide to voluntarily
terminate the accreditation with their home infusion therapy AOs
simultaneously.
(f) Burden for Home Infusion Therapy AOs Associated With Sec. 488.1050
Section 488.1050(a) would provide that a home infusion therapy AO
that is dissatisfied with a determination, made by CMS, that its home
infusion therapy accreditation requirements do not provide or do not
continue to provide reasonable assurance that the suppliers accredited
by the home infusion therapy AO meet the applicable quality standards
is entitled to reconsideration.
[[Page 56607]]
Section 488.1050(b)(1) would require that a written request for
reconsideration be filed within 30 calendar days of the receipt of CMS'
notice of an adverse determination or non-renewal. Section
488.1050(b)(2) would provide that the written request for
reconsideration must specify the findings or issues with which the home
infusion therapy AO disagrees and the reasons for the disagreement.
Section 488.1050(c)(1) provides the opportunity for a hearing to be
conducted by a hearing officer appointed by the Administrator of CMS
and Sec. 488.1050(c)(2) provides that written notice of the time and
place of the hearing will be provided at least 10 business days before
the scheduled date.
We estimate that it would take approximately 2 hours for a home
infusion therapy AO to prepare its request for reconsideration. We
believe that the person at the AO who would prepare the request for
reconsideration would most likely be a clinician such as a registered
nurse. According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the
home infusion therapy AO associated with the preparation of the request
for reconsideration would be $141.44 (2 hours x $35.36 per hour =
$70.72) + ($70.72 for fringe benefits and overhead).
The remaining information that would be submitted in connection
with a request for reconsideration or a reconsideration hearing,
including any evidence or testimony provided is not considered
``information'' in accordance with 5 CFR 1320.3(h)(8), which excludes
as ``information'' any ``facts or opinions obtained or solicited at or
in connection with public hearings.''
It is important to note that we have not calculated the burden
associated with the tasks required of the home infusion therapy AO
under Sec. 488.1050 across all of the potential home infusion therapy
AOs. We have not done so because we believe that the filing of a
request for reconsideration by a home infusion therapy AO would occur
rarely, if ever. Further, we do not believe that there would ever be a
situation in which all 6 of the potential home infusion therapy AOs
would decide to file a request for reconsideration at the same time.
Therefore, there would never be an occurrence where all the home
infusion therapy AOs would incur the previously stated burden
simultaneously.
(g) Burdens for Home Infusion Therapy AOs Related to Survey Activities
and Accreditation of Home Infusion Therapy Suppliers
The home infusion therapy AO would incur time and cost associated
the accreditation of home infusion therapy suppliers. These would
include the time and costs required to perform an onsite survey,
offsite survey or other type of survey activity for each home infusion
therapy supplier that has hired that AO to provide accreditation.
However, as we have not approved any home infusion therapy AOs, we do
not yet know what type of home infusion therapy accreditation standards
they will use, or what the home infusion therapy accreditation survey
process will consist of. Therefore, we are unable to accurately
estimate the time and cost burden associated with the survey of home
infusion therapy suppliers.
However, we can state that if the home infusion therapy AO were to
perform an onsite survey, it would incur wages for each of the
surveyors that are sent to perform the survey for the amount of time
spent performing the survey. The AO would also incur wages for the time
spent by the surveyors or other home infusion therapy AO staff in
reviewing the survey documents, making a decision about whether to
grant accreditation to the home infusion therapy supplier that was
surveyed and preparing the decision letter to the home infusion therapy
supplier. The AO would also incur travel costs for the AO staff to
travel to the home infusion therapy supplier's location to perform the
survey.
If the home infusion therapy AO were to do an offsite records audit
survey, the AO would request that the home infusion therapy supply the
AO with specific records. The AO would incur costs for the wages of the
AO staff that performed the audit of the documents provided by the home
infusion therapy supplier. The AO would also incur wages for the time
spent by the surveyors or other home infusion therapy AO staff in
making a decision about whether to grant accreditation to the home
infusion therapy supplier that was audited and preparing the decision
letter to the home infusion therapy supplier.
We solicited comment on how to estimate this burden and receive
none.
2. Burden to Home Infusion Therapy Suppliers Related to Home Infusion
Therapy Health and Safety Standards
All existing home infusion therapy suppliers are already accredited
by existing home infusion therapy AOs to meet requirements established
by private insurers and Medicare Advantage plans. We that, in order for
the existing home infusion therapy suppliers accredited by these AOs to
continue to receive payment for the home infusion therapy services
provided, these AOs must obtain Medicare approval for a home infusion
therapy accreditation program. To obtain this CMS approval, we that
these AOs would be required to submit an application to CMS seeking
approval of a home infusion therapy accreditation program that meets
the requirements set forth in the new home infusion therapy AO approval
and oversight regulations and new home infusion therapy health and
safety regulations. We would also require that the home infusion
therapy program submitted by these AOs be separate and distinct from
the AOs home health deeming accreditation program.
It is likely that the home infusion therapy suppliers would need to
be resurveyed after their home infusion therapy AO obtains CMS approval
of a home infusion therapy accreditation program, under section
1861(iii)(3)(D)(i)(III) of the Act. We believe this resurvey would be
necessary because the AOs would have to determine if the home infusion
therapy suppliers they accredit meet their new Medicare-approved home
infusion therapy accreditation program accreditation standards.
However, if a current home infusion therapy AOs current home infusion
therapy standards already meet or exceed the home infusion therapy
health and safety standards, so that a revision of that AOs home
infusion therapy accreditation standards is not required, then a
resurvey of that AO's accredited home infusion therapy suppliers may
not be necessary.
The home infusion therapy supplier would incur some time burden in
order to come into compliance with the home infusion therapy AOs new
home infusion therapy accreditation program requirements initially and
thus prepare for the accreditation survey. However, all existing home
infusion therapy suppliers are already accredited by existing home
infusion therapy AOs to meet requirements established by private
insurers and Medicare Advantage plans. Therefore, we assume that there
would be little, is any new burden imposed on home infusion therapy
suppliers in order to implement the new health and safety standards.
The home infusion therapy supplier would be charged a fee by the AO
for providing accreditation services. Fees for the home infusion
therapy
[[Page 56608]]
accreditation currently offered by the six AOs listed previously
accreditation programs offered by the six AOs listed previously vary
between $5,950 and $12,500 and, in general, currently cover all of the
following items: Application fee, manuals, initial accreditation fee,
onsite surveys or other auditing (generally once every 3 years), and
travel, when necessary for survey personnel. Accreditation costs also
vary by the size of the provider or supplier seeking accreditation, its
number of locations, and the number of services it provides.
We recognize that cost and time burdens associated with becoming
accredited may be a barrier for small suppliers such as home infusion
therapy suppliers. We are implementing the following to minimize the
burden of accreditation on suppliers, including small businesses:
Multiple accreditation organizations--We expect that more
than one AO would submit an application to become a designated Home
Infusion Therapy AO. We believe that selection of more than one home
infusion therapy AO would introduce competition resulting in reductions
in accreditation costs.
Required plan for small businesses--During the application
process we would require prospective home infusion therapy AOs to
include a plan that details their methodology to reduce accreditation
fees and burden for small or specialty suppliers. This would need to
include that the AO's fees are based on the size of the organization.
Reasonable quality standards--The quality standards that
would be used to evaluate the services rendered by each home infusion
therapy supplier are being in this rule. Many home infusion therapy
suppliers already comply with the standards and have incorporated these
practices into their daily operations. It is our belief that compliance
with the quality standards would result in more efficient and effective
business practices and would assist suppliers in reducing overall
costs.
There are at least two important sources of uncertainty in
estimating the impact of accreditation on home infusion therapy
suppliers. First, our estimates assume that all home infusion therapy
suppliers with positive Medicare payments would seek accreditation. We
assume that home infusion therapy suppliers who currently receive no
Medicare allowed charges would choose not to seek accreditation. It is
also possible that many of the home infusion therapy suppliers with
allowed charges between $1 and $1,000 may decide not to incur the costs
of accreditation.
Second, it is difficult to predict what accreditation fees would be
in the future. Our experience with other accreditation programs has
lead us to believe that the accreditation rates would go up, due to
factors such as wage increases, and increased travel costs. To monitor
accreditation fees, we proposed to require the AOs for home infusion
therapy suppliers to submit their fees to CMS for review for
reasonableness. We would require home infusion therapy AOs to notify
CMS anytime there is an increase in accreditation fees.
(d) Medicare-Certified Accreditation Organizations--Proposed Changes to
42 CFR 488.5
We proposed to modify the AO approval and oversight regulations for
Medicare-certified providers and suppliers by adding two new
requirements. The first new requirement would have been to add to 42
CFR 488.5(a)(7) a requirement that in their application for CMS
approval, the AOs that accredited Medicare-certified providers and
suppliers include a statement acknowledging that all accrediting
organization surveyors have completed or will complete the relevant
program-specific CMS online trainings established for state surveyors,
initially, and thereafter. As stated previously, after consideration of
the numerous comments we received in response to this proposal, we
decided not to finalize this proposal. Therefore the burden estimates
provided in the proposed rule regarding the proposed time and cost
burden related to the requirement that AO surveyors take the CMS online
surveyor training are no longer relevant.
The second requirement was to add Sec. 488.5(a)(18)(iii) to would
require that the AOs for Medicare-certified providers and suppliers
include a written statement in their application for CMS approval
agreeing that if a fully accredited and deemed facility in good
standing provides written notification that they wish to voluntarily
withdraw from the accrediting organization's CMS-approved accreditation
program, the accrediting organization must continue the facility's
current accreditation in full force and effect until the effective date
of withdrawal identified by the facility or the expiration date of the
term of accreditation, whichever comes first. As stated previously, we
have made a decision to finalize this proposal without change or
modifications.
(1) Burden Associated With the Online Training Requirement for AO
Surveyors
A number of commenters expressed concern that the requirement that
AO surveyors take the CMS online training would impose significant
burden on the surveyors. Other commenters stated the belief that the AO
training was adequate and that it was similar to the CMS online
training, therefore the training requirement would be duplicative.
Therefore, after consideration of the comments received, we have
decided not to finalize the proposal to require AO surveyors to take
the CMS online surveyor training.
(2) Burden Associated With the Statement Requirement for AOs
We finalized that AOs approved in accordance with section 1865 of
the Act, and regulated under part 488 subpart A, provide a written
statement in their application in which they agree to continue a
provider's or supplier's current accreditation in full force and effect
until the effective date of withdrawal identified by the facility or
the expiration date of the term of accreditation, whichever comes
first.
Section 488.5(a)(18)(iii) would require the AOs for Medicare-
certified providers and suppliers to include a written statement in
their application for CMS approval of their accreditation program,
agreeing that if a fully accredited and deemed facility in good
standing provides written notification that they wish to voluntarily
withdraw from the accrediting organization's CMS-approved accreditation
program, the accrediting organization must continue the facility's
current accreditation in full force and effect until the effective date
of withdrawal identified by the facility or the expiration date of the
term of accreditation, whichever comes first.
We believe that the AOs that accredit Medicare-certified providers
and suppliers would incur limited burden associated with this
requirement, because this regulation simply requires that the AOs to
include a statement in their application stating that they agree to
continue the facility's current accreditation in full force and effect
until the effective date of withdrawal identified by the facility or
the expiration date of the term of accreditation, whichever comes
first, if a provider of supplier provides written notification that
they wish to voluntarily withdraw from the accrediting organization's
CMS-approved accreditation program. We believe that this written
statement to be provided by the AO would consist of
[[Page 56609]]
only 1 to 2 paragraphs and would take no more than 15 minutes to
prepare.
We believe that a clinicians such as registered nurses would
prepare the required statement to be included in the AOs application.
According to the U.S. Bureau of Labor Statistics, the mean hourly wage
for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the AOs that
accredit Medicare-certified providers and suppliers associated with the
preparation of the required statement would be approximately $17.68
((15 minutes x $35.36 per hour = $8.84) + ($8.84 for fringe benefits
and overhead)).
There are nine AOs that accredit Medicare-certified providers and
suppliers. The cost across all AOs for the completion of this task
would be $158.12 (($8.84 x 9 AOs = $79.56) + ($79.56 for fringe
benefits and overhead)). However, AOs for Medicare-certified providers
and suppliers are required to submit a renewal application only every 6
years. Therefore, the existing AOs would be required to submit the
statement stating that they agree to continue the facility's current
accreditation in full force and effect until the effective date of
withdrawal identified by the facility or the expiration date of the
term of accreditation, whichever comes first, if a provider of supplier
provides written notification that they wish to voluntarily withdraw
from the accrediting organization's CMS-approved accreditation program
with their next renewal application which is submitted after the
publication of the final rule. While we have calculated the cost for
the performance of this task across all AOs that accredit Medicare-
certified providers and suppliers, it is important to note that the
existing AOs are scheduled to submit their renewal applications at
varying dates and times over a period of several years. Therefore there
will be no time period in which all of these AOs will incur these
expenses simultaneously.
D. Detailed Economic Analysis
1. HH PPS
This rule finalizes updates for the CY 2019 HH PPS rates contained
in the CY 2018 HH PPS final rule (82 FR 51676 through 51752). The
impact analysis of this final rule with comment period presents the
estimated expenditure effects of policy changes in this final rule with
comment period. 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 2017. 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.
a. HH PPS for CY 2019
Table 44 represents how HHA revenues are likely to be affected by
the policy changes in this rule for CY 2019. For this analysis, we used
an analytic file with linked CY 2017 OASIS assessments and HH claims
data for dates of service that ended on or before December 31, 2017.
The first column of Table 44 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 2019 wage index and revised labor share. The fourth column shows
the payment effects of the CY 2019 case-mix weights. The fifth column
shows the effects of the new rural add-on payment provision in statute.
The sixth column shows the effects of the revised FDL ratio used to
calculate outlier payments, and the seventh column shows the effects of
the CY 2019 home health payment update percentage.
The last column shows the combined effects of all the policies in
this rule. Overall, it is projected that aggregate payments in CY 2019
would increase by 2.2 percent. As illustrated in Table 44, 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 2019 wage index, the extent to which
HHAs had episodes in case-mix groups where the case-mix weight
decreased for CY 2019 relative to CY 2018, 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.
BILLING CODE 4120-01-P
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b. HH PPS for CY 2020 (PDGM)
Table 45 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 2017 OASIS assessments and CY 2017 HH
claims data (as of March 2, 2018) for dates of service that ended on or
before December 31, 2017. The first column of Table 45 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 HHAs in the impact analysis. The PDGM, as required
by Section 51001(a)(2)(A) of the BBA of 2018, will be implemented in a
budget neutral manner and the third column shows the total impact of
the PDGM as outlined in section III.F of this final rule with comment
period. As illustrated in Table 45, the effect of the PDGM varies by
specific types of providers and location. We note that some individual
HHAs within the same group may experience different impacts on payments
than others. This is due to distributional differences among HHAs with
regards to the percentage of total HH PPS payments that were subject to
the low-utilization payment adjustment (LUPA) or paid as outlier
payments, the degree of Medicare utilization, and the ratio of overall
visits that were provided as therapy versus skilled nursing.
As outlined in section III.F of this final rule with comment
period, several OASIS items would no longer be needed to case-mix
adjust the 30-day payment under the PDGM; therefore, we would make 19
current OASIS items (48 data elements) optional at the follow-up (FU)
time point starting January 1, 2020. As also discussed in section
III.F. of this final rule with comment period, in order to calculate
the case-mix adjusted payment amount for the PDGM, we would add the
collection of two current OASIS items (10 data elements) at the FU time
point starting January 1, 2020. Section X. of this final rule with
comment period provides a detailed description of the net decrease in
burden associated with these changes in conjunction with the changes in
burden that result from OASIS item collection changes due to the
removal of certain measures required under HH QRP, also effective for
January 1, 2020 as outlined in section V.E. of this final rule with
comment period. Due to the modifications to OASIS item collection as a
result of the changes to the HH QRP and the changes to the HH PPS
(PDGM), both effective on and after January 1, 2020, we estimate that
this rule generates $60 million in annualized cost savings, or $46
million per year on an ongoing basis discounted at 7 percent relative
to year 2016, over a perpetual time horizon beginning in CY 2020.
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In response to the CY 2019 case-mix adjustment methodology
refinements proposed in the CY 2018 HH PPS proposed rule (82 FR 35270),
a few commenters requested that CMS include more information in the
impact table for the PDGM, specifically how payments are impacted for
patients with selected clinical conditions as was included in the
Technical Report which is available at: https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf. Therefore, we are
including Table 46 which provides more information on the impact of the
PDGM case-mix adjustment methodology for patients with selected
clinical conditions.
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2. HHVBP Model
Table 47 displays our analysis of the distribution for possible
payment adjustments at the maximum 7-percent and 8-percent rates that
will be used in Years 4 and 5 of the Model. These analyses use
performance year data from 2016, the first year of HHVBP, the most
recent year for which complete performance year data are available. The
estimated impacts are for the following finalized changes, each of
which will take effect beginning with PY4 (2019):
Remove two OASIS-based measures (Influenza Immunization
Received for Current Flu Season and Pneumococcal Polysaccharide Vaccine
Ever Received);
Replace three OASIS-based measures (Improvement in
Bathing, Improvement in Bed Transferring, and Improvement in
Ambulation-Locomotion) with two composite measures (Total Change in
Self Care, Total Change in Mobility);
Reduce the maximum possible improvement points from 10 to
9 (13.5 for the two composite measures); and,
Change the weights given to the performance measures used
in the Model so that the OASIS and claims-based measures each count for
35 percent and the HHCAHPS measures count for 30 percent of the 90
percent of the Total Performance Score (TPS) that is based on
performance on the Clinical Quality of Care, Care Coordination and
Efficiency, and Person and Caregiver-Centered Experience measures. Data
reporting for each New Measure will continue to have equal weight and
account for the 10 percent of the TPS that is based on the New Measures
collected as part of the Model. The weight of the unplanned
hospitalization measure will also be increased so that it has three
times the weight of the ED use without hospitalization measure.
We analyzed the payment adjustment percentage and the number of
eligible HHAs under current policy to determine the impacts of the
changes finalized in this rule. We used PY1 (CY2016) data to measure
the impacts. The data sources for these analyses are data from the QIES
system for the existing OASIS and claims-based measures, OASIS
assessments for the two composite measures, HHCAHPS data received from
the HHCAHPS contractor, and New Measure data submitted by Model
participants. HHAs are classified as being in the smaller or larger
volume cohort using the 2016 Quality Episode File, which is created
using OASIS assessments. We note that this impact analysis is based on
the aggregate value across all nine Model states.
Table 48 displays our analysis of the estimated impact of the
policies finalized in this rule on the number of eligible HHAs and the
distribution of percentage change in payment adjustment percentage
based on the same PY1 (CY2016) data used to calculate Table 47. We note
that this impact analysis is based on the aggregate value across all
nine Model
[[Page 56616]]
states. Note that all Medicare-certified HHAs that provide services in
Massachusetts, Maryland, North Carolina, Florida, Washington, Arizona,
Iowa, Nebraska, and Tennessee are required to compete in this Model.
The analysis is calculated at the state and size cohort level. It is
expected that a certain number of HHAs would not have a payment
adjustment because they may be servicing too small of a population to
report an adequate number of measures to calculate a TPS. Table 48
shows that there would be a reduction in the number of HHAs that would
have a sufficient number of measures to receive a payment adjustment
for performance year 4 of 31 HHAs (Change column), a decrease from
1,610 HHAs (Current column) to 1,579 HHAs (Simulated column) across the
nine selected states.
This analysis reflects only HHAs that would have data for at least
five measures that meet the requirements of Sec. 484.305 and would be
included in the Linear Exchange Function and would have a payment
adjustment calculated. Value-based incentive payment adjustments for
the estimated eligible 1,579 HHAs in the selected states that would
compete in the HHVBP Model are stratified by size as described in
section IV.B. of the CY 2017 HH PPS final rule. As finalized in section
IV.B. of the CY 2017 final rule, there must be a minimum of eight HHAs
in any cohort.
Those HHAs that are in states that do not have at least eight
smaller-volume HHAs will not have a separate smaller-volume cohort and
thus there will only be one cohort that will include all the HHAs in
that state. As indicated in Table 48, Maryland, North Carolina,
Tennessee, Washington, and Arizona would have only one cohort while
Florida, Iowa, Massachusetts, and Nebraska would have both a smaller-
volume cohort and a larger-volume cohort. For example, Iowa would have
17 HHAs eligible to be exempt from being required to have their
beneficiaries' complete HHCAHPS surveys because they provide HHA
services to less than 60 beneficiaries. Therefore, those 17 HHAs would
be competing in Iowa's smaller-volume cohort for CY 2019 (PY4) under
the Model.
Table 48 shows the distribution of percentage change in payment
adjustment percentage resulting from the policies finalized in this
rule. Using 2016 data and the maximum payment adjustment for
performance year 4 of 7 percent (as applied in CY 2021), based on the
six finalized OASIS quality measures and two claims-based measures in
QIES, the five HHCAHPS measures, and the three New Measures, we see
that, across all nine states, 31 HHAs would no longer be eligible for a
payment adjustment for PY4 because they would not have data on at least
five measures that meet the requirements of Sec. 484.305. The
distribution of scores by percentile shows the distribution of the
change in percent payment adjustment. For example, the distribution for
HHAs in Florida in the smaller-volume cohort ranges from -2.5 percent
at the 10th percentile to +2.9 percent at the 90th percentile. This
means that, for 7 of the 77 HHAs in the smaller-volume cohort in
Florida, the changes would decrease their payment adjustment percentage
by -2.5 percent or more while, for another 7 HHAs these changes would
increase their payment adjustment percentage by 2.9 percent or more.
For half of the HHAs in Florida's smaller volume cohort, the impact of
these changes on their payment adjustment percentage would be between -
1.1 percent and +1.3 percent. These impact analyses suggest that, for
most participating HHAs, the impacts of the changes would be modest.
Table 49 provides the payment adjustment distribution based on
agency size, proportion of dually-eligible beneficiaries, average case
mix (using the average case-mix for non-LUPA episodes), the proportion
of the HHA's beneficiaries that reside in rural areas and HHA
organizational status. HHAs with a higher proportion of dually-eligible
beneficiaries and HHAs whose beneficiaries have higher acuity tend to
have a more negative impact associated with the policies finalized in
this rule based on the 50th percentile of the impact of the changes on
payment adjustment percentage.
Table 50 shows the current and revised weights, as finalized in
this rule, for individual performance measures by measure category and
possible applicable measure category scenarios to demonstrate the
weight of the individual measures when an HHA has scores on All
Measures or if an HHA is missing all measures in a measure category.
For example, for an HHA that has quality measure scores on All Measures
in all the measure categories (OASIS-based, claims-based and HHCAHPS)
under the current weighting method, the individual measures are
weighted equally. The Finalized Weights columns show the revised
weights for the individual performance measures based on the changes to
the weighting methodology finalized in this final rule with comment
period; specifically, to weight the measure categories so that the
OASIS-based measure category and the claims-based measure category will
each count for 35 percent and the HHCAHPS measure category will count
for 30 percent of the 90 percent of the TPS that is based on
performance of the Clinical Quality of Care, Care Coordination and
Efficiency, and Person and Caregiver-Centered Experience measures. For
example, for HHAs with scores on All Measures, the OASIS-based measures
account for 35 percent, with equal weighting given to the Improvement
in Oral Medications, Improvement in Dyspnea, Improvement in Pain, and
Discharge to Community measures. The Composite Self-Care and Composite
Mobility measures will be weighted 1.5 times more than the other OASIS-
based measures so that the maximum score for the two composite measures
is the same as for the three functional OASIS-based measures that they
are replacing (Improvement in Ambulation, Bathing and Bed
Transferring). Under the revised weights, the two claims-based
measures, which will collectively account for 35 percent, will not be
weighted equally. We are finalizing that the weight of the acute care
hospitalization measure will be three times higher than that of the ED
Use measure. Thus, its weight will be 26.25 percent while the weight of
the ED Use measure will be 8.75 percent for an HHA that reported on all
measures. The HHCAHPS measures will account for 30 percent and each
measure will be weighted equally.
Table 50 also shows the number of HHAs that would have enough
measures to receive a payment adjustment under each possible scoring
scenario under both the current and revised weighting methodologies.
Most of the HHAs that would no longer receive a payment adjustment with
the changes finalized in this rule are those with no claims or HHCAHPS
measures. With only OASIS measures, these HHAs are more impacted by the
finalized policy to remove the two immunization measures and the
finalized policy to replace three OASIS functional measures with the
two composite measures. The number of HHAs without claims or HHCAHPS
measures that would have enough OASIS-based measures to receive a
payment adjustment would drop from 99 to 73 (a decrease of 26 HHAs),
and the majority of these HHAs would be smaller HHAs (16 of the 26
HHAs).
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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. In
section V.G. of this final rule with comment period, we revised our
regulations at Sec. 484.250(a) to clarify that not all OASIS data
described in Sec. 484.55(b) and (d) are needed for purposes of
complying with the requirements of the HH QRP. There are no changes in
this final rule with comment period in our method for applying the 2
percentage point reduction to HHAs that fail to meet the HH QRP
requirements. For the CY 2018 annual payment update determination,
1,311 of the 11,776 active Medicare-certified HHAs, or approximately
11.1 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 2019 payment determination.
In section V.E. of this final rule with comment period, we are
removing seven measures from the HH QRP: Depression Assessment
Conducted, Diabetic Foot Care and Patient/Caregiver Education
Implemented during All Episodes of Care, Multifactor Fall Risk
Assessment Conducted For All Patients Who Can Ambulate (NQF #0537),
Pneumococcal Polysaccharide Vaccine Ever Received, Improvement in the
Status of Surgical Wounds, Emergency Department Use without Hospital
Readmission during the First 30 Days of HH (NQF #2505), and
Rehospitalization during the First 30 Days of HH (NQF #2380). Their
associated burden decreases are for CY 2020 because HHAs will no longer
be required to submit data on these measures beginning CY 2020. As
noted previously, section X. of this final rule with comment period
provides a detailed description of the net decrease in burden
associated with these changes in conjunction with the changes in burden
that result from the implementation of the PDGM for CY 2020. Due to the
modifications to OASIS item collection as a result of the changes to
the HH QRP and the changes to the HH PPS (PDGM), both effective on and
after January 1, 2020; we estimate that this rule generates $60 million
in annualized cost savings, or $46 million per year on an ongoing basis
discounted at 7 percent relative to year 2016, over a perpetual time
horizon beginning in CY 2020.
4. Home Infusion Therapy Payment
The following analysis applies to the Temporary Transitional
Payment for Home Infusion Therapy as set forth in section 1834(u)(7) of
the Act, as added by section 50401 of the BBA of 2018 (Pub. L. 115-
123), and accordingly, describes the impact for CY 2019 only. Table 51
represents the estimated increased Medicare costs of existing
beneficiaries who are furnished DME and are currently using home
infusion therapy services. We used CY 2017 data to identify
beneficiaries with DME claims containing 1 of the 37 HCPCS codes
identified in section 1834(u)(7)(C) of the Act, which are shown in
column 2. In column 3, 2017 claims were again used to determine the
total weeks of care, which is the sum of weeks of care across all
beneficiaries found in each category. Weeks of care for payment
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. For Category 2, we used the median number of weeks of care, 47, as
many patients use immune globulin for the whole year. Column four
assumes the initial week of care requires two nurse visits, and all
subsequent weeks only require one visit, in order to estimate the total
visits of care per category. In general, nursing visits for payment
category 2, subcutaneous immune globulin (SCIG) administration, occur
once per month; therefore, we assume the estimated number of visits for
these patients is 12. The fifth column multiplies the volume of nurse
visits across beneficiaries by the payment rate (using the 2018
Physician Fee Schedule amounts) in order to estimate the increased cost
per each of the three infusion drug categories.\87\ At the time of
publication, we did not have the 2019 Physician Fee Schedule rate in
order to complete our impact analysis; however, actual payments
starting on January 1, 2019 would be based on the Physician Fee
Schedule amounts as specified in section 50401 of the BBA of 2018.
---------------------------------------------------------------------------
\87\ Based on the 2018 Medicare PFS these rates are $141.12
($74.16 + 3 * $22.32) for Category 1, $224.28 ($176.76 + 3 * $15.84)
for Category 2, and $239.76 ($144.72 + 3 * $31.68) for Category 3.
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Table 52 displays the estimated regional impacts using the
beneficiary enrollment address reported in the Medicare Master
Beneficiary Summary File. Table 53 displays impacts based on rural or
urban designations. All beneficiaries identified had at least one
applicable home infusion claim (claims with 1 of the 37 drug codes
listed in section 1834(u)(7)(C) of the Act) in CY 2017. Unknown
beneficiaries were those without valid state and county
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information in the Master Beneficiary Summary File. Additionally, the
tables provide the estimated impacts by drug category.
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E. Alternatives Considered
1. HH PPS
a. HH PPS for CY 2019
Section 1895(b)(3)(B) of the Act requires that the standard
prospective payment amounts for CY 2019 be increased by a factor equal
to the applicable HH market basket update for those HHAs that submit
quality data as required by the Secretary. For CY 2019, Section
1895(b)(3)(B)(vi) of the Act requires that the market basket update
under the HHA prospective payment system be adjusted by changes in
economy-wide productivity. The 0.8 percentage point multifactor
productivity adjustment to the CY 2019 home health market basket update
of 3.0 percent, is discussed in the preamble of this final rule with
comment period and is not discretionary as it is a requirement in
section 1895(b)(3)(B)(vi)(I) of the Act.
We considered not rebasing the home health market basket. However,
we believe that it is desirable to rebase the home health market basket
periodically so that the cost category weights reflect changes in the
mix of goods and services that HHAs purchase in furnishing home health
care. In addition, we considered not implementing the revision to the
labor-related share of 76.1 percent in a budget neutral manner.
However, we believe it is more prudent to implement the revision to the
labor-related share in a manner that does not increase or decrease
budgetary expenditures.
With regards to payments made under the HH PPS for high-cost
outlier episodes of care (that is, episodes of care with unusual
variations in the type or amount of medically necessary care), we did
not consider maintaining the current FDL ratio of 0.55. As discussed in
section III.E.3. of this final rule with comment period, we revise the
FDL ratio to 0.51. Simulations using CY 2017 claims data and the CY
2019 HH PPS payment rates resulted in an estimated 2.32 percent of
total HH PPS payments being paid as outlier payments using the existing
methodology for calculating the cost of an episode of care. The FDL
ratio and the loss-sharing ratio must be selected so that the estimated
outlier payments do not exceed the 2.5 percent of total HH PPS payments
(as required by section 1895(b)(5)(A) of the Act). Therefore, lowering
the FDL ratio results in 2.32% in outlier payments that rises closer to
but does not exceed the 2.5% in total outlier payments. We did not
consider proposing a change to the loss sharing ratio (0.80) in order
for the HH PPS to remain consistent with payment for high-cost outliers
in other Medicare payment systems (for example, IRF PPS, IPPS, etc.)
b. HH PPS for CY 2020 (PDGM)
For CY 2020, we did not consider alternatives to changing the unit
of payment from 60 days to 30 days, eliminating the use of therapy
thresholds for the case-mix adjustment, and requiring the revised
payments to be budget neutral. Section 51001 of the BBA of 2018
requires the change in the unit of payment from 60 days to 30 days to
be made in a budget neutral manner and mandates the elimination of the
use of therapy thresholds for case-mix adjustment purposes. The BBA of
2018 also requires these measures to be implemented on January 1, 2020
and that we make assumptions about behavior changes that could occur as
a result of the implementation of the 30-day unit of payment and as a
result of the case-mix adjustment factors that are implemented in CY
2020 in calculating a 30-day payment amount for CY 2020 in a budget
neutral manner.
Alternatives to making 19 current OASIS items (48 data elements)
optional at the FU time point as outlined in section X. of this final
rule with comment period, would be to either not implement the case-mix
adjustment methodology changes under the PDGM or to continue collecting
the 19 current OASIS items at the FU time point, even though they would
not be used to case-mix adjust payments under the PDGM. Similarly, an
alternative to adding collection of two current OASIS items (10 data
elements) at the FU time point as discussed in section X. of this final
rule with comment period would be to either not adopt the PDGM or not
to include the two current OASIS items (M1800 and M1033) as part of the
case-mix adjustment methodology under the PDGM. As noted previously, we
did not consider not implementing the case-mix methodology changes
under the PDGM as a new case-mix adjustment methodology is required to
be implemented in accordance with section 51001 of the BBA of 2018,
which mandates the elimination of the use of therapy thresholds for
case-mix adjustment purposes by January 1, 2020. We believe that
continuing to require HHAs to report responses for the 19 current OASIS
items at the FU time point that are no longer needed for case-mix
adjustment purposes under the PDGM results in unnecessary burden for
HHAs. While requiring HHAs to report responses for two current OASIS
items at the FU time point results in a small increase in burden if CMS
were to not make 19 current OASIS items optional at the FU time point,
those two OASIS items (M1800 and M1033) are correlated with increases
in resource use and are used to determine the patient's functional
impairment level under the HHGM, thus they are important for case-mix
adjustment purposes in order to ensure accurate payments to HHAs under
the PDGM.
We considered whether to continue using the wage-weighted minutes
of care (WWMC) approach to estimate resource use under the PDGM, as
described in section III.F.2. of this final rule with comment period.
Although the relationship in relative costs between the WWMC approach
and the cost-per-minute plus non-routine supplies (CPM+NRS) approach is
very similar (correlation coefficient equal to 0.8512), the WWMC
approach does not as evenly weight skilled nursing costs relative to
therapy costs as evidenced in the cost report data and would require us
to maintain a separate case-mix adjustment mechanism for NRS. If we
were to maintain the current WWMC approach, skilled nursing and therapy
costs would not be as evenly weighted and a certain level of complexity
in calculating payments under the HH PPS would persist as we would need
to continue with the current method of case-mix adjusting NRS payments
separate from service costs (that is, skilled nursing, physical
therapy, occupational therapy, speech-language pathology, home health
aide, and medical social services) under the HH PPS.
In this final rule with comment period and to begin in CY 2020, we
considered proposing a phase-out of the split percentage payment
approach by reducing the percentage of the upfront payment over a
period of time and requiring a notice of admission (NOA) to be
submitted upon full elimination of the split-percentage payment.
However, we wanted to take the opportunity in this year's rule to more
clearly signal our intent to potentially eliminate the split percentage
payment approach over time as a reduced timeframe for the unit of
payment (30 days rather than 60 days) is now required in statute. Given
that existing HHAs (certified with effective dates prior to January 1,
2019) would need to adapt to changes in cash flow with the elimination
of the split percentage payment approach, we hope to receive additional
feedback on the timeframes for a phase-out of the split percentage
payment approach and whether there is a need for an NOA upon completion
of a phase-out of the split percentage payment approach that we can
take into consideration for potential future rulemaking.
[[Page 56625]]
2. HHVBP Model
We considered various alternatives to our proposals for the HHVBP
Model. For the vaccination measures, we considered continuing to
include them in the applicable measure set instead of removing them.
However, for the reasons discussed in section IV of this final rule
with comment period, we are finalizing our proposal to remove the two
vaccination measures beginning with PY4.
With regard to our proposal to replace three OASIS-based measures
with two composite measures, we also considered making no changes to
the OASIS-based measures category.
Another alternative to this proposal would be to finalize one but
not both composite measures. We discussed in the proposed rule the
proposed scoring that would apply if we adopted this alternative.
However, for the reasons discussed in section IV.B of this final rule
with comment period, we are finalizing the replacement of the three
OASIS-based measures with the two new composite measures.
An alternative to rescoring the maximum improvement points from 10
points to 9 points would be to keep the current scoring methodology.
However, for the reasons discussed in section IV.B in this final rule
with comment period, we are finalizing our proposal to rescore the
maximum improvement points from 10 points to 9 points (or 13.5 points
for the composite measures).
An alternative to reweighting the OASIS-based, claims-based and
HHCAHPS measure categories would be to keep the current equally
weighted methodology. For the reasons discussed in section IV.B of this
final rule with comment period, we are finalizing reweighting of the
OASIS-based measure category to 35 percent, the claims-based measure
category to 35 percent and the HHCAHPS measure category to 30 percent
in order to encourage increased focus on the claims-based measures.
3. HH QRP
An alternative to removing seven measures from the HH QRP
(Depression Assessment Conducted, Diabetic Foot Care and Patient/
Caregiver Education Implemented during All Episodes of Care,
Multifactor Fall Risk Assessment Conducted For All Patients Who Can
Ambulate (NQF #0537), Pneumococcal Polysaccharide Vaccine Ever
Received, Improvement in the Status of Surgical Wounds, Emergency
Department Use without Hospital Readmission during the First 30 Days of
HH (NQF #2505), Rehospitalization during the First 30 Days of HH (NQF
#2380)), as discussed in section V.E. of this final rule with comment
period, would have been to retain these measures in the HH QRP.
4. Home Infusion Therapy
a. Health and Safety Standards
We considered establishing additional health and safety
requirements related to patient assessment, infection control and
quality improvement. However, according to the home infusion therapy
supplier industry, and our research, we believe there are already some
AOs that include requirements related to patient assessment, quality
improvement, and infection control. To the extent that we subsequently
determine that federal standards are necessary, we will propose them in
subsequent notice and comment rulemaking.
b. Payment
We did not consider alternatives to implementing the home infusion
therapy benefit for CY 2019 and 2020 because section 1834(u)(7) of the
Act requires the Secretary to provide a temporary transitional payment
to eligible home infusion therapy suppliers for items and services
associated with the furnishing of transitional home infusion drugs.
c. Accreditation of Qualified Home Infusion Therapy Suppliers
AOs that accredit home infusion therapy suppliers must become
accredited by an AO designated by the Secretary. In these options, we
have attempted to minimize the burden of accreditation on home infusion
therapy suppliers, which include approving home infusion therapy AOs
that consider the unique needs of small home infusion therapy
suppliers. Also, it is likely that the surveys of home infusion therapy
suppliers would be performed as a desk review instead of an onsite
survey. Doing a desk audit survey would prevent the travel time and
cost that is required when the AO has to send a survey team to the home
infusion therapy supplier's location to perform an onsite survey.
F. Accounting Statement and Tables
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars_a004_a-4), in Table 54, we have
prepared an accounting statement showing the classification of the
transfers and costs associated with the CY 2019 HH PPS provisions of
this rule. For CY 2020, due to the section 51001(a) of the BBA of 2018
requirement that the transition to the 30-day unit of payment be budget
neutral, Table 55 displays a transfer of zero. Table 56 provides our
best estimates of the changes to OASIS item collection as a result of
the implementation of the PDGM and changes to the HH QRP. Table 57
provides our best estimate of the increase in Medicare payments to home
infusion therapy suppliers related to the temporary transitional
payment for home infusion therapy in CY 2019. Table 58 provides our
best estimate of cost of AO compliance with our home infusion the
Infusion Therapy application requirements.
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[[Page 56626]]
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BILLING CODE 4120-01-C
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.''
Details on the estimated costs of this final rule with comment period,
including limitations on the ability thus far to quantify some
categories of impacts, can be found in the rule's economic analysis.
This final rule with comment period is considered an E.O. 13771
deregulatory action. Details on the estimated cost savings of this
final rule with comment period can be found in the rule's PRA and
economic analysis. Due to the modifications to OASIS item collection as
a result of the changes to the HH QRP and the changes to the HH PPS
(PDGM), both effective on and after January 1, 2020, we estimate that
this rule generates $60 million in annualized cost savings, or $46
million per year on an ongoing basis discounted at 7 percent relative
to year 2016, over a perpetual time horizon beginning in CY 2020.
H. Conclusion
1. HH PPS
a. HH PPS for CY 2019
In conclusion, we estimate that the net impact of the HH PPS
policies in this rule is an increase of 2.2 percent, or $420 million,
in Medicare payments to HHAs for CY 2019. The $420 million increase
reflects the effects of the CY 2019 home health payment update of 2.2
percent ($420 million increase), a 0.1 percent increase in payments due
to decreasing the FDL ratio in order to target to pay no more than 2.5
percent of total payments as outlier payments ($20 million increase),
and a -0.1 percent decrease in CY 2019 payments due to the new rural
add-on policy mandated by the BBA of 2018 ($20 million decrease).
b. HH PPS for CY 2020 (PDGM)
In conclusion, we estimate that Medicare payments to HHAs for CY
2020 will remain the same compared to CY 2019 as a result of the
implementation of the PDGM. Section 51001(a) of the BBA of 2018
requires the Secretary to implement the 30-day unit of payment in a
budget-neutral manner.
2. OASIS Changes Related to the HH QRP and HH PPS (PDGM) for CY 2020
In conclusion, we estimate that the changes to OASIS item
collection as a result of the changes to the HH QRP and the changes to
the HH PPS (PDGM), both effective on and after January 1, 2020, would
result in a net $60 million in annualized cost savings, discounted at 7
percent relative to year 2016, over
[[Page 56627]]
a perpetual time horizon beginning in CY 2020.
In conclusion, due to the modifications to OASIS item collection as
a result of the changes to the HH QRP and the changes to the HH PPS
(PDGM), both effective on and after January 1, 2020, we estimate that
this rule generates $60 million in annualized cost savings, or $46
million per year on an ongoing basis discounted at 7 percent relative
to year 2016, over a perpetual time horizon beginning in CY 2020.
4. Home Infusion Therapy
a. Health and Safety Standards
In summary, the health and safety standards would not have any
economic impact on home infusion therapy suppliers or accreditation
organizations.
b. Payment
In conclusion, we estimate that the net impact of the temporary
transitional payment to eligible home infusion suppliers for items and
services associated with the furnishing of transitional home infusion
drugs would result in approximately $48 million in additional Medicare
payments to home infusion suppliers in CY 2019.
c. Accreditation of Qualified Home Infusion Therapy Suppliers
In summary, AOs that accredit HIT suppliers must become accredited
by an AO designated by the Secretary. In these options, we have
attempted to minimize the burden of accreditation on HIT suppliers,
which include approving AOs that consider the unique needs of small HIT
suppliers. Also, it is likely that the surveys of HIT suppliers will be
performed as a desk review instead of an onsite survey. Doing a desk
audit survey would prevent the travel time and cost that is required
when the AO has to send a survey team to the HIT supplier's location to
perform an onsite survey.
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
finalized rule was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 409
Health facilities, Medicare.
42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
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.
42 CFR Part 488
Administrative practice and procedure, Health facilities, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 409--HOSPITAL INSURANCE BENEFITS
0
1. The authority citation for part 409 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
Sec. 409.43 [Amended]
0
2. Section 409.43 is amended--
0
a. By removing paragraph (c)(2);
0
b. By resignating paragraphs (c)(3) and (4) as paragraphs (c)(2) and
(3);
0
c. In newly redesignated paragraph (c)(2)(ii) by removing the phrase
``for services is submitted for the final percentage prospective
payment'' and adding in its place the phrase ``(for episodes beginning
on or before December 31, 2019) or 30-day period (for periods beginning
on or after January 1, 2020) is submitted''; and
0
d. In paragraph (e)(1)(iii) by removing the phrase ``during the 60-day
episode'' and adding in its place the phrase ``within 60 days''.
0
3. Section 409.46 is amended by adding paragraph (e) to read as
follows:
Sec. 409.46 Allowable administrative costs.
* * * * *
(e) Remote patient monitoring. Remote patient monitoring is defined
as the collection of physiologic data (for example, ECG, blood
pressure, or glucose monitoring) digitally stored and transmitted by
the patient or caregiver or both to the home health agency. If remote
patient monitoring is used by the home health agency to augment the
care planning process, the costs of the equipment, set-up, and service
related to this system are allowable only as administrative costs.
Visits to a beneficiary's home for the sole purpose of supplying,
connecting, or training the patient on the remote patient monitoring
equipment, without the provision of a skilled service are not
separately billable.
PART 424--CONDITIONS FOR MEDICARE PAYMENT
0
4. The authority citation for part 424 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
5. Section 424.22 is amended by revising paragraphs (b)(2) and (c) to
read as follows:
Sec. 424.22 Requirements for home health services.
* * * * *
(b) * * *
(2) Content and basis of recertification. As a condition for
payment of home health services under Medicare Part A or Medicare Part
B, if there is a continuing need for home health services, a physician
must recertify the patient's continued eligibility for the home health
benefit as outlined in sections 1814(a)(2)(C) and 1835(a)(2)(A) of the
Act, as set forth in paragraph (a)(1) of this section, and as specified
in paragraphs (b)(2)(i) and (ii) of this section.
(i) Need for occupational therapy may be the basis for continuing
services that were initiated because the individual needed skilled
nursing care or physical therapy or speech therapy.
(ii) If a patient's underlying condition or complication requires a
registered nurse to ensure that essential non-skilled care is achieving
its purpose, and necessitates a registered nurse be involved in the
development, management, and evaluation of a patient's care plan, the
physician must include a brief narrative describing the clinical
justification of this need. If the narrative--
(A) Is part of the recertification form, then the narrative must be
located immediately prior to the physician's signature.
(B) Exists as an addendum to the recertification form, in addition
to the physician's signature on the recertification form, the physician
must sign immediately following the narrative in the addendum.
(c) Determining patient eligibility for Medicare home health
services. (1) Documentation in the certifying physician's medical
records or the acute/post-acute care facility's medical records (if the
patient was directly admitted to home health) or both must be used as
the basis for certification of the patient's eligibility for home
health as described in paragraphs (a)(1) and (b) of this section.
Documentation from the HHA may also be used to support the basis for
certification of home health eligibility, but only if the following
requirements are met:
[[Page 56628]]
(i) The documentation from the HHA can be corroborated by other
medical record entries in the certifying physician's medical record for
the patient or the acute/post-acute care facility's medical record for
the patient or both, thereby creating a clinically consistent picture
that the patient is eligible for Medicare home health services.
(ii)(A) The certifying physician signs and dates the HHA
documentation demonstrating that the documentation from the HHA was
considered when certifying patient eligibility for Medicare home health
services.
(B) HHA documentation can include, but is not limited to, the
patient's plan of care required under Sec. 409.43 of this chapter, or
the initial or comprehensive assessment of the patient required under
Sec. 484.55 of this chapter.
(2) The documentation must be provided upon request to review
entities or CMS or both. If the documentation used as the basis for the
certification of eligibility is not sufficient to demonstrate that the
patient is or was eligible to receive services under the Medicare home
health benefit, payment is not rendered for home health services
provided.
* * * * *
PART 484--HOME HEALTH SERVICES
0
6. The authority citation for part 484 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh unless otherwise indicated.
0
7. Section 484.202 is amended by revising the definitions of ``Rural
area'' and ``Urban area'' to read as follows:
Sec. 484.202 Definitions.
* * * * *
Rural area means an area defined in Sec. 412.64(b)(1)(ii)(C) of
this chapter.
Urban area means an area defined in Sec. 412.64(b)(1)(ii)(A) and
(B) of this chapter.
0
8. Section 484.205 is revised to read as follows:
Sec. 484.205 Basis of payment.
(a) Method of payment. An HHA receives a national, standardized
prospective payment amount for home health services previously paid on
a reasonable cost basis (except the osteoporosis drug defined in
section 1861(kk) of the Act) as of August 5, 1997. The national,
standardized prospective payment is determined in accordance with Sec.
484.215.
(b) Unit of payment--(1) Episodes before December 31, 2019. For
episodes beginning on or before December 31, 2019, an HHA receives a
unit of payment equal to a national, standardized prospective 60-day
episode payment amount.
(2) Periods on or after January 1, 2020. For periods beginning on
or after January 1, 2020, a HHA receives a unit of payment equal to a
national, standardized prospective 30-day payment amount.
(c) OASIS data. A HHA must submit to CMS the OASIS data described
at Sec. 484.55(b) and (d) in order for CMS to administer the payment
rate methodologies described in Sec. Sec. 484.215, 484.220, 484. 230,
484.235, and 484.240.
(d) Payment adjustments. The national, standardized prospective
payment amount represents payment in full for all costs associated with
furnishing home health services and is subject to the following
adjustments and additional payments:
(1) A low-utilization payment adjustment (LUPA) of a predetermined
per-visit rate as specified in Sec. 484.230.
(2) A partial payment adjustment as specified in Sec. 484.235.
(3) An outlier payment as specified in Sec. 484.240.
(e) Medical review. All payments under this system may be subject
to a medical review adjustment reflecting the following:
(1) Beneficiary eligibility.
(2) Medical necessity determinations.
(3) Case-mix group assignment.
(f) Durable medical equipment (DME) and disposable devices. DME
provided as a home health service as defined in section 1861(m) of the
Act is paid the fee schedule amount. Separate payment is made for
``furnishing NPWT using a disposable device,'' as that term is defined
in Sec. 484.202, and is not included in the national, standardized
prospective payment.
(g) Split percentage payments. Normally, there are two payments
(initial and final) paid for an HH PPS unit of payment. The initial
payment is made in response to a request for anticipated payment (RAP)
as described in paragraph (h) of this section, and the residual final
payment is made in response to the submission of a final claim. Split
percentage payments are made in accordance with requirements at Sec.
409.43(c) of this chapter.
(1) Split percentage payments for episodes beginning on or before
December 31, 2019--(i) Initial and residual final payments for initial
episodes on or before December 31, 2019. (A) The initial payment for
initial episodes is paid to an HHA at 60 percent of the case-mix and
wage-adjusted 60-day episode rate.
(B) The residual final payment for initial episodes is paid at 40
percent of the case-mix and wage-adjusted 60-day episode rate.
(ii) Initial and residual final payments for subsequent episodes
before December 31, 2019. (A) The initial payment for subsequent
episodes is paid to an HHA at 50 percent of the case-mix and wage-
adjusted 60-day episode rate.
(B) The residual final payment for subsequent episodes is paid at
50 percent of the case-mix and wage-adjusted 60-day episode rate.
(2) Split percentage payments for periods beginning on or after
January 1, 2020--(i) Initial and residual final payments for initial
periods beginning on or after January 1, 2020. (A) The initial payment
for initial 30-day periods is paid to an HHA at 60 percent of the case-
mix and wage-adjusted 30-day payment rate.
(B) The residual final payment for initial 30-day periods is paid
at 40 percent of the case-mix and wage-adjusted 30-day payment rate.
(ii) Initial and residual final payments for subsequent periods
beginning on or after January 1, 2020. (A) The initial payment for
subsequent 30-day periods is paid to an HHA at 50 percent of the case-
mix and wage-adjusted 30-day payment rate.
(B) The residual final payment for subsequent 30-day periods is
paid at 50 percent of the case-mix and wage-adjusted 30-day payment
rate.
(iii) Split percentage payments 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. 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.
(h) Requests for anticipated payment (RAP). (1) HHAs that are
certified for participation in Medicare effective by December 31, 2018
submit requests for anticipated payment (RAPs) to request the initial
split percentage payment as specified in paragraph (g) of this section.
HHAs that are certified for participation in Medicare effective on or
after January 1, 2019 are still required to submit RAPs although no
split percentage payments are made in response to these RAP
submissions. The HHA can submit a RAP when all of the following
conditions are met:
(i) After the OASIS assessment required at Sec. 484.55(b)(1) and
(d) is complete, locked or export ready, or there is an agency-wide
internal policy establishing the OASIS data is finalized for
transmission to the national assessment system.
[[Page 56629]]
(ii) Once a physician's verbal orders for home care have been
received and documented as required at Sec. Sec. 484.60(b) and
409.43(d) of this chapter.
(iii) A plan of care has been established and sent to the physician
as required at Sec. 409.43(c) of this chapter.
(iv) The first service visit under that plan has been delivered.
(2) A RAP is based on the physician signature requirements in Sec.
409.43(c) of this chapter and is not a Medicare claim for purposes of
the Act (although it is a ``claim'' for purposes of Federal, civil,
criminal, and administrative law enforcement authorities, including but
not limited to the following:
(i) Civil Monetary Penalties Law (as defined in 42 U.S.C. 1320a-
7a(i)(2)).
(ii) The Civil False Claims Act (as defined in 31 U.S.C. 3729(c)).
(iii) The Criminal False Claims Act (18 U.S.C. 287)).
(iv) The RAP is canceled and recovered unless the claim is
submitted within the greater of 60 days from the end date of the
appropriate unit of payment, as defined in paragraph (b) of this
section, or 60 days from the issuance of the RAP.
(3) CMS has the authority to reduce, disprove, or cancel a RAP in
situations when protecting Medicare program integrity warrants this
action.
Sec. 484.210 [Removed and Reserved]
0
9. Section 484.210 is removed and reserved.
0
10. Section 484.215 is amended--
0
a. By revising the section heading;
0
b. In paragraph (d) introductory text by removing the phrase ``CMS
calculates the'' and adding in its place the phrase ``For episodes
beginning on or before December 31, 2019, CMS calculates the''; and
0
c. By adding paragraph (f).
The revision and addition reads as follows:
Sec. 484.215 Initial establishment of the calculation of the
national, standardized prospective payment rates.
* * * * *
(f) For periods beginning on or after January 1, 2020, a national,
standardized prospective 30-day payment rate applies. The national,
standardized prospective 30-day payment rate is an amount determined by
the Secretary, as subsequently adjusted in accordance with Sec.
484.225.
0
11. Section 484.220 is amended--
0
a. By revising the section heading and introductory text; and
0
b. In paragraph (a) introductory text by removing the phrase ``national
prospective 60-day episode'' and adding in its place the phrase
``national, standardized prospective''.
The revisions read as follows:
Sec. 484.220 Calculation of the case-mix and wage area adjusted
prospective payment rates.
CMS adjusts the national, standardized prospective payment rates as
referenced in Sec. 484.215 to account for the following:
* * * * *
0
12. Section 484.225 is amended--
0
a. By revising the section heading and paragraph (a);
0
b. In paragraphs (b) and (c) by removing the phrase ``national
prospective 60-day episode'' and adding in its place the phrase
``national, standardized prospective''; and
0
c. By adding paragraph (d).
The revision and addition reads as follows:
Sec. 484.225 Annual update of the unadjusted national, standardized
prospective payment rates.
(a) CMS annually updates the unadjusted national, standardized
prospective payment rate on a calendar year basis (in accordance with
section 1895(b)(1)(B) of the Act).
* * * * *
(d) For CY 2020, the national, standardized prospective 30-day
payment amount is an amount determined by the Secretary. CMS annually
updates this amount on a calendar year basis in accordance with
paragraphs (a) through (c) of this section.
0
13. Section 484.230 is revised to read as follows:
Sec. [thinsp]484.230 Low-utilization payment adjustments.
(a) For episodes beginning on or before December 31, 2019, an
episode with four or fewer visits is paid the national per-visit amount
by discipline determined in accordance with Sec. 484.215(a) and
updated annually by the applicable market basket for each visit type,
in accordance with Sec. 484.225.
(1) The national per-visit amount is adjusted by the appropriate
wage index based on the site of service of the beneficiary.
(2) An amount is added to the low-utilization payment adjustments
for low-utilization episodes that occur as the beneficiary's only
episode or initial episode in a sequence of adjacent episodes.
(3) For purposes of the home health PPS, a sequence of adjacent
episodes for a beneficiary is a series of claims with no more than 60
days without home care between the end of one episode, which is the
60th day (except for episodes that have been PEP-adjusted), and the
beginning of the next episode.
(b) For periods beginning on or after January 1, 2020, an HHA
receives a national 30-day payment of a predetermined rate for home
health services, unless CMS determines at the end of the 30-day period
that the HHA furnished minimal services to a patient during the 30-day
period.
(1) For each payment group used to case-mix adjust the 30-day
payment rate, the 10th percentile value of total visits during a 30-day
period of care is used to create payment group specific thresholds with
a minimum threshold of at least 2 visits for each case-mix group.
(2) A 30-day period with a total number of visits less than the
threshold is paid the national per-visit amount by discipline
determined in accordance with Sec. 484.215(a) and updated annually by
the applicable market basket for each visit type, in accordance with
Sec. 484.225.
(3) The national per-visit amount is adjusted by the appropriate
wage index based on the site of service for the beneficiary.
(c) An amount is added to low-utilization payment adjustments for
low-utilization periods that occur as the beneficiary's only 30-day
period or initial 30-day period in a sequence of adjacent periods of
care. For purposes of the home health PPS, a sequence of adjacent
periods of care for a beneficiary is a series of claims with no more
than 60 days without home care between the end of one period, which is
the 30th day (except for episodes that have been partial payment
adjusted), and the beginning of the next episode.
0
14. Section 484.235 is revised to read as follows:
Sec. [thinsp]484.235 Partial payment adjustments.
(a) Partial episode payments (PEPs) for episodes beginning on or
before December 31, 2019. (1) An HHA receives a national, standardized
60-day payment of a predetermined rate for home health services unless
CMS determines an intervening event, defined as a beneficiary elected
transfer or discharge with goals met or no expectation of return to
home health and the beneficiary returned to home health during the 60-
day episode, warrants a new 60-day episode for purposes of payment. A
start of care OASIS assessment and physician certification of the new
plan of care are required.
(2) The PEP adjustment does not apply in situations of transfers
among HHAs of common ownership.
(i) Those situations are considered services provided under
arrangement on behalf of the originating HHA by the receiving HHA with
the common
[[Page 56630]]
ownership interest for the balance of the 60-day episode.
(ii) The common ownership exception to the transfer PEP adjustment
does not apply if the beneficiary moves to a different MSA or Non-MSA
during the 60-day episode before the transfer to the receiving HHA.
(iii) The transferring HHA in situations of common ownership not
only serves as a billing agent, but must also exercise professional
responsibility over the arranged-for services in order for services
provided under arrangements to be paid.
(3) If the intervening event warrants a new 60-day payment and a
new physician certification and a new plan of care, the initial HHA
receives a partial episode payment adjustment reflecting the length of
time the patient remained under its care based on the first billable
visit date through and including the last billable visit date. The PEP
is calculated by determining the actual days served as a proportion of
60 multiplied by the initial 60-day payment amount.
(b) Partial payment adjustments for periods beginning on or after
January 1, 2020. (1) An HHA receives a national, standardized 30-day
payment of a predetermined rate for home health services unless CMS
determines an intervening event, defined as a beneficiary elected
transfer or discharge with goals met or no expectation of return to
home health and the beneficiary returned to home health during the 30-
day period, warrants a new 30-day period for purposes of payment. A
start of care OASIS assessment and physician certification of the new
plan of care are required.
(2) The partial payment adjustment does not apply in situations of
transfers among HHAs of common ownership.
(i) Those situations are considered services provided under
arrangement on behalf of the originating HHA by the receiving HHA with
the common ownership interest for the balance of the 30-day period.
(ii) The common ownership exception to the transfer partial payment
adjustment does not apply if the beneficiary moves to a different MSA
or Non-MSA during the 30-day period before the transfer to the
receiving HHA.
(iii) The transferring HHA in situations of common ownership not
only serves as a billing agent, but must also exercise professional
responsibility over the arranged-for services in order for services
provided under arrangements to be paid.
(3) If the intervening event warrants a new 30-day payment and a
new physician certification and a new plan of care, the initial HHA
receives a partial payment adjustment reflecting the length of time the
patient remained under its care based on the first billable visit date
through and including the last billable visit date. The partial payment
is calculated by determining the actual days served as a proportion of
30 multiplied by the initial 30-day payment amount.
0
15. Section 484.240 is revised to read as follows:
Sec. [thinsp]484.240 Outlier payments.
(a) For episodes beginning on or before December 31, 2019, an HHA
receives an outlier payment for an episode whose estimated costs
exceeds a threshold amount for each case-mix group. The outlier
threshold for each case-mix group is the episode payment amount for
that group, or the PEP adjustment amount for the episode, plus a fixed
dollar loss amount that is the same for all case-mix groups.
(b) For periods beginning on or after January 1, 2020, an HHA
receives an outlier payment for a 30-day period whose estimated cost
exceeds a threshold amount for each case-mix group. The outlier
threshold for each case-mix group is the 30-day payment amount for that
group, or the partial payment adjustment amount for the 30-day period,
plus a fixed dollar loss amount that is the same for all case-mix
groups.
(c) The outlier payment is a proportion of the amount of imputed
cost beyond the threshold.
(d) CMS imputes the cost for each claim by multiplying the national
per-15 minute unit amount of each discipline by the number of 15 minute
units in the discipline and computing the total imputed cost for all
disciplines.
0
16. Section 484.250 is amended by revising paragraph (a)(1) to read as
follows:
Sec. 484.250 Patient assessment data.
(a) * * *
(1) Such 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; and such OASIS data described at Sec. 484.55(b) and (d) as is
necessary to meet the quality reporting requirements of section
1895(b)(3)(B)(v) of the Act.
* * * * *
0
17. Section 484.320 is amended by revising paragraph (c) to read as
follows:
Sec. 484.320 Calculation of the Total Performance Score.
* * * * *
(c)(1) For performance years 1 through 3, CMS will sum all points
awarded for each applicable measure excluding the New Measures,
weighted equally at the individual measure level to calculate a value
worth 90 percent of the Total Performance Score.
(2) For performance years 4 and 5, CMS will sum all points awarded
for each applicable measure within each category of measures (OASIS-
based, claims-based and HHCAHPS) excluding the New Measures, weighted
at 35 percent for the OASIS-based measure category, 35 percent for the
claims-based measure category, and 30 percent for the HHCAHPS measure
category when all three measure categories are reported, to calculate a
value worth 90 percent of the Total Performance Score.
* * * * *
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY SUPPLIERS
0
18. The authority citation for part 486 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
19. Add reserved subpart H and subpart I to read as follows:
Subpart H--[Reserved]
Subpart I--Requirements for Home Infusion Therapy Suppliers
General Provisions
Sec.
486.500 Basis and scope.
486.505 Definitions.
Standards for Home Infusion Therapy
486.520 Plan of care.
486.525 Required services.
Subpart I--Requirements for Home Infusion Therapy Suppliers
General Provisions
Sec. 486.500 Basis and scope.
Section 1861(s)(2)(iii) of the Act requires the Secretary to
establish the conditions that home infusion therapy suppliers must meet
in order to participate in the Medicare program and which are
considered necessary to ensure the health and safety of patients.
Sec. 486.505 Definitions.
As used in Sec. Sec. 486.520 and 486.525:
Applicable provider means a physician, a nurse provider, and a
physician assistant.
Home means a place of residence used as the home of an individual,
including an institution that is used as a home. An institution that is
used as a home may not be a hospital, CAH, or
[[Page 56631]]
SNF as defined in section 1861(e)(1), 1861(mm)(1), or 1819(a)(1) of the
Act, respectively.
Home infusion drug means a parental 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. The term does not include insulin
pump systems or a self-administered drug or biological on a self-
administered drug exclusion list.
Infusion drug administration calendar day means the day on which
home infusion therapy services are furnished by skilled professionals
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.
Qualified home infusion therapy supplier means a supplier of home
infusion therapy that meets the all of the following criteria which are
set forth at section 1861(iii)(3)(D)(i) of the Act:
(1) Furnishes infusion therapy to individuals with acute or chronic
conditions requiring administration of home infusion drugs.
(2) Ensures the safe and effective provision and administration of
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
(3) Is accredited by an organization designated by the Secretary in
accordance with section 1834(u)(5) of the Act.
(4) Meets such other requirements as the Secretary determines
appropriate.
Standards for Home Infusion Therapy
Sec. 486.520 Plan of care.
The qualified home infusion therapy supplier ensures the following:
(a) All patients must be under the care of an applicable provider.
(b) All patients must have a plan of care established by a
physician that prescribes the type, amount, and duration of the home
infusion therapy services that are to be furnished.
(c) The plan of care for each patient must be periodically reviewed
by the physician.
Sec. 486.525 Required services.
(a) The qualified home infusion therapy supplier must provide the
following services on a 7-day-a-week, 24-hour-a-day basis in accordance
with the plan of care:
(1) Professional services, including nursing services.
(2) Patient training and education not otherwise paid for as
durable medical equipment as described in Sec. 424.57(c)(12) of this
chapter.
(3) Remote monitoring and monitoring services for the provision of
home infusion therapy services and home infusion drugs.
(b) All home infusion therapy suppliers must provide home infusion
therapy services in accordance with nationally recognized standards of
practice, and in accordance with all applicable state and federal laws
and regulations.
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
0
20. The authority citation for part 488 is revised to read as follows:
Authority: 42 U.S.C 1302 and 1395hh.
0
21. Section 488.5 is amended--
0
a. In paragraph (a)(17)(i) by removing the word ``and'' at the end of
the paragraph;
0
b. In paragraph (a)(17)(ii) by removing the period and adding in its
place ``; and''; and
0
c. By adding paragraph (a)(17)(iii).
The additions read as follows:
Sec. 488.5 Application and re-application procedures for national
accrediting organizations.
(a) * * *
(17) * * *
(iii) Include a written statement that if a fully accredited and
deemed facility in good standing provides written notification that
they wish to voluntarily withdraw from the accrediting organization's
CMS-approved accreditation program, the accrediting organization must
continue the facility's current accreditation in full force and effect
until the effective date of withdrawal identified by the facility or
the expiration date of the term of accreditation, whichever comes
first.
* * * * *
0
22. Add reserved subpart K and subpart L to read as follows:
Subpart K--[Reserved]
Subpart L--Accreditation of Home Infusion Therapy Suppliers
General Provisions
Sec.
488.1000 Basis and scope.
488.1005 Definitions.
Approval and Oversight of Home Infusion Therapy Supplier Accrediting
Organizations
488.1010 Application and reapplication procedures for national home
infusion therapy accrediting organizations.
488.1015 Resubmitting a request for reapproval.
488.1020 Public notice and comment.
488.1025 Release and use of home infusion therapy accreditation
surveys.
488.1030 Ongoing review of home infusion therapy accrediting
organizations.
488.1035 Ongoing responsibilities of a CMS-approved home infusion
therapy accreditation organization.
488.1040 Onsite observations of home infusion therapy accrediting
organization operations.
488.1045 Voluntary and involuntary termination.
488.1050 Reconsideration.
Subpart L--Accreditation of Home Infusion Therapy Suppliers
General Provisions
Sec. 488.1000 Basis and scope.
(a) Regulatory basis for home infusion therapy services. The home
infusion therapy health and safety regulations are codified at part
486, subpart I, of this chapter.
(b) Statutory basis for the accreditation of home infusion therapy
suppliers. (1) Sections 1102 and 1871 of the Act require that the
Secretary prescribe such regulations as may be necessary to carry out
the administration of the Medicare program.
(2) Section 1834(u)(5) of the Act require the Secretary to
designate and approve independent organizations for the purposes of
accrediting qualified home infusion therapy suppliers.
(c) Scope. This subpart sets forth the following:
(1) Application and reapplication procedures for national
accrediting organizations seeking approval or re-approval of authority
to accredit qualified home infusion therapy suppliers.
(2) Ongoing CMS oversight processes for approved accrediting
organizations that accredit qualified home infusion therapy suppliers.
(3) Appeal procedures for accrediting organizations that accredit
qualified home infusion therapy suppliers.
Sec. 488.1005 Definitions.
As used in this subpart--
Immediate jeopardy means a situation in which the provider's or
supplier's non-compliance with one or more Medicare accreditation
requirements has caused, or is likely to cause, serious injury, harm,
impairment, or death to a patient.
National accrediting organization means an organization that
accredits provider or supplier entities under a specific program and
whose accredited provider or supplier entities under each program are
widely dispersed geographically across the United States. In addition,
the specific program is
[[Page 56632]]
active, fully implemented, and operational.
National in scope means a program is fully implemented,
operational, and widely dispersed geographically throughout the
country.
Qualified home infusion therapy supplier means a supplier of home
infusion therapy that meets the all of the following criteria which are
set forth at section 1861(iii)(3)(D)(i) of the Act:
(1) Furnishes infusion therapy to individuals with acute or chronic
conditions requiring administration of home infusion drugs.
(2) Ensures the safe and effective provision and administration of
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
(3) Is accredited by an organization designated by the Secretary in
accordance with section 1834(u)(5) of the Act.
(4) Meets such other requirements as the Secretary determines
appropriate.
Reasonable assurance means an accrediting organization has
demonstrated to CMS' satisfaction that its accreditation program
requirements meet or exceed the Medicare program requirements.
Rural area as defined at section 1886(d)(2)(D) of the Act.
Substantial allegation of non-compliance means a complaint from any
of a variety of sources (such as patient, relative, or third party),
including complaints submitted in person, by telephone, through written
correspondence, or in the newspaper, magazine articles or other media,
that would, if found to be present, adversely affect the health and
safety of patients and raises doubts as to a qualified home infusion
therapy supplier's compliance with the applicable Medicare
accreditation requirements.
Approval and Oversight of Home Infusion Therapy Supplier Accrediting
Organizations
Sec. 488.1010 Application and reapplication procedures for national
home infusion therapy accrediting organizations.
(a) Information submitted with application. A national home
infusion therapy accrediting organization applying to CMS for approval
or re-approval of a designated home infusion therapy accreditation
program must furnish CMS with information and materials that
demonstrate that its home infusion therapy accreditation program
requirements meet or exceed the applicable Medicare requirements for
accrediting organizations, including the following:
(1) Documentation that demonstrates the organization meets the
definition of a national accrediting organization under Sec. 488.1005
as it relates to the accreditation program.
(2) The Medicare provider or supplier type for which the
organization is requesting approval or reapproval.
(3) Documentation that demonstrates the home infusion therapy
accrediting organization's ability to take into account the capacities
of rural home infusion therapy suppliers (as required by section
1834(u)(5)(A)(ii) of the Act).
(4) Information that demonstrates the home infusion therapy
accrediting organization's knowledge, expertise, and experience in home
infusion therapy.
(5) A detailed crosswalk (in table format) that identifies, for
each of the applicable Medicare requirements, the exact language of the
organization's comparable accreditation requirements and standards.
(6) A detailed description of the home infusion therapy accrediting
organization's survey processes to confirm that a home infusion therapy
supplier's processes are comparable to those of Medicare. This
description must include all of the following:
(i) The types and frequency of surveys performed, and a rationale
for which accreditation requirements will be evaluated via onsite
surveys and which will be evaluated via offsite audits, or other
strategies for ensuring accredited home infusion therapy suppliers
maintain adherence to the home infusion therapy accreditation program
requirements, including an explanation of how the accrediting
organization will maintain the schedule it proposes.
(ii) Copies of the home infusion therapy accrediting organizations
survey and audit forms, guidelines, and instructions to surveyors.
(iii) Documentation demonstrating that the home infusion therapy
accrediting organization's onsite survey or offsite audit reports
identify, for each finding of non-compliance with accreditation
standards, the comparable Medicare home infusion therapy accreditation
requirements, as applicable.
(iv) A description of the home infusion therapy accrediting
organization's accreditation survey review process.
(v) A description of the home infusion therapy accrediting
organization's procedures and timelines for notifying a surveyed or
audited home infusion therapy supplier of non-compliance with the home
infusion therapy accreditation program's standards.
(vi) A description of the home infusion therapy accrediting
organization's procedures and timelines for monitoring the home
infusion therapy supplier's correction of identified non-compliance
with the accreditation program's standards.
(vii) The ability of the home infusion therapy accrediting
organization to conduct timely reviews of accreditation applications.
(viii) A statement acknowledging that, as a condition for CMS
approval of a national accrediting organization's accreditation
program, the home infusion therapy accrediting organization agrees to
provide CMS with information extracted from each home infusion therapy
accreditation onsite survey, offsite audit or other evaluation
strategies as part of its data submissions required under paragraph
(a)(19) of this section, and, upon request from CMS, a copy of the most
recent accreditation onsite survey, offsite audit, or other evaluation
strategy together with any other information related to the survey as
CMS may require (including corrective action plans).
(ix) A statement acknowledging that the home infusion therapy
accrediting organization will provide timely notification to CMS when
an accreditation survey or complaint investigation identifies an
immediate jeopardy as that term is defined at Sec. 488.1005. Using the
format specified by CMS, the home infusion therapy accrediting
organization must notify CMS within 2 business days from the date the
accrediting organization identifies the immediate jeopardy.
(7) Procedures to ensure that--
(i) Unannounced onsite surveys, as appropriate, will be conducted
periodically, including procedures that protect against unannounced
surveys becoming known to the provider or supplier in advance of the
visit; or
(ii) Offsite survey audits are performed to evaluate the quality of
services provided which may be followed up with periodic onsite visits.
(8) The criteria for determining the size and composition of the
home infusion therapy accrediting organization's survey, audit and
other evaluation strategy teams for individual supplier onsite surveys.
The home infusion therapy accrediting organization's criteria should
include, but not be limited to the following information:
(i) The expected number of individual home infusion therapy
supplier locations to be surveyed using an onsite survey.
(ii) The number of home infusion therapy suppliers to be surveyed
using off-site audits.
[[Page 56633]]
(iii) A description of other types of home infusion therapy
accreditation review activities to be used.
(iv) The reasons for each type of survey (that is, initial
accreditation survey, reaccreditation survey, and complaint survey).
(9) The overall adequacy of the number of the home infusion therapy
accrediting organization's surveyors, auditors, and other staff
available to perform survey related activities, including how the
organization will increase the size of the survey, audit, and other
evaluation staff to match growth in the number of accredited facilities
or programs while maintaining re-accreditation intervals for existing
accredited facilities or programs.
(10) Detailed information about the individuals who perform onsite
surveys, offsite audits or other strategies for ensuring accredited
home infusion therapy suppliers maintain adherence to the home infusion
therapy accreditation program requirements, including all of the
following information:
(i) The number and types of professional and technical staff
available for conducting onsite surveys, offsite audits, or other
strategies for ensuring accredited home infusion therapy suppliers
maintain adherence to the home infusion therapy accreditation program
requirements.
(ii) The education, employment, and experience requirements
surveyors and auditors must meet.
(iii) The content and length of the orientation program.
(11) The content, frequency and types of in-service training
provided to survey and audit personnel.
(12) The evaluation systems used to monitor the performance of
individual surveyors, auditors and survey teams.
(13) The home infusion therapy accrediting organization's policies
and procedures to avoid conflicts of interest, including the appearance
of conflicts of interest, involving individuals who conduct surveys,
audits or participate in accreditation decisions.
(14) The policies and procedures used when a home infusion therapy
supplier has a dispute regarding survey or audit findings, or an
adverse decision.
(15) Procedures for the home infusion therapy supplier to use to
notify the home infusion therapy accrediting organization when the
accredited home infusion therapy supplier does the either of the
following:
(i) Removes or ceases furnishing services for which they are
accredited.
(ii) Adds services for which they are not accredited.
(16) The home infusion therapy accrediting organization's
procedures for responding to, and investigating complaints against
accredited facilities, including policies and procedures regarding
referrals, when applicable, to appropriate licensing bodies, ombudsmen
offices, and CMS.
(17) A description of the home infusion therapy accrediting
organization's accreditation status decision-making process. The home
infusion therapy accrediting organization must furnish the following:
(i) Its process for addressing deficiencies identified with
accreditation program requirements, and the procedures used to monitor
the correction of deficiencies identified during an accreditation
survey and audit process.
(ii) A description of all types and categories of accreditation
decisions associated with the program, including the duration of each
of the organization's accreditation decisions.
(iii) Its policies and procedures for the granting, withholding or
removal of accreditation status for facilities that fail to meet the
accrediting organization's standards or requirements, assignment of
less than full accreditation status or other actions taken by the
organization in response to non-compliance with its standards and
requirements.
(iv) A statement acknowledging that the home infusion therapy
accrediting organization agrees to notify CMS (in a manner CMS
specifies) of any decision to revoke, terminate, or revise the
accreditation status of a home infusion therapy supplier, within 3
business days from the date the organization takes an action.
(18) A list of all currently accredited home infusion therapy
suppliers, the type and category of accreditation, currently held by
each, and the expiration date for each home infusion therapy supplier's
current accreditation.
(19) A schedule of all survey activity (such as onsite surveys,
offsite audits and other types if survey strategies) expected to be
conducted by the organization during the 6-month period following
submission of an initial or renewal application.
(20) A written presentation that demonstrates the organization's
ability to furnish CMS with electronic data.
(21) A description of the home infusion therapy accrediting
organization's data management and analysis system with respect to its
surveys and accreditation decisions, including all of the following:
(i) A detailed description of how the home infusion therapy
accrediting organization uses its data to assure the compliance of its
home infusion therapy accreditation program with the Medicare home
infusion therapy accreditation program requirements.
(ii) A written statement acknowledging that the home infusion
therapy accrediting organization agrees to submit timely, accurate, and
complete data that CMS has determined is both necessary to evaluate the
accrediting organization's performance and is not unduly burdensome for
the accrediting organization to submit.
(A) The organization must submit necessary data according to the
instructions and timeframes CMS specifies.
(B) Data to be submitted includes the following:
(1) Accredited home infusion therapy supplier identifying
information.
(2) Survey findings.
(3) Quality measures.
(4) Notices of accreditation decisions.
(22) The three most recent annual audited financial statements of
the home infusion therapy accrediting organization that demonstrate
that the organization's staffing, funding, and other resources are
adequate to perform the required surveys, audits, and related
activities to maintain the accreditation program.
(23) A written statement acknowledging that, as a condition for
approval, the home infusion therapy accrediting organization agrees to
the following:
(i) Voluntary termination. Provide written notification to CMS and
all home infusion therapy suppliers accredited under its CMS-approved
home infusion therapy accreditation program at least 180 calendar days
in advance of the effective date of a decision by the home infusion
therapy accrediting organization to voluntarily terminate its CMS-
approved home infusion therapy accreditation program and the
implications for the suppliers' payment status once their current term
of accreditation expires in accordance with the requirements at Sec.
488.1045(a).
(ii) Involuntary termination. Provide written notification to all
accredited home infusion therapy suppliers accredited under its CMS-
approved home infusion therapy accreditation program no later than 30
calendar days after the notice is published in the Federal Register
announcing that CMS is withdrawing its approval of its accreditation
program and the implications for the home infusion therapy supplier's
payment status in accordance with the requirements at Sec. 488.1045(b)
once their current term of accreditation expires.
(A) For both voluntary and involuntary terminations, provide a
second written notification to all
[[Page 56634]]
accredited home infusion therapy suppliers 10 calendar days prior to
the organization's accreditation program effective date of termination.
(B) Notify CMS, in writing (electronically or hard copy), within 2
business days of a deficiency identified in any accredited home
infusion therapy supplier from any source where the deficiency poses an
immediate jeopardy to the home infusion therapy supplier's
beneficiaries or a hazard to the general public.
(iii) Summary accreditation activity data and trends. Provide, on
an annual basis, summary accreditation activity data and trends
including the following:
(A) Deficiencies.
(B) Complaints.
(C) Terminations.
(D) Withdrawals.
(E) Denials.
(F) Accreditation decisions.
(G) Other survey-related activities as specified by CMS.
(iv) Termination of an accreditation organization. If CMS
terminates a home infusion therapy accrediting organization's approved
status, the home infusion therapy accrediting organization must work
collaboratively with CMS to direct its accredited home infusion therapy
suppliers to the remaining CMS-approved accrediting organizations
within a reasonable period of time.
(v) Notification of proposed changes. Notify CMS at least 60 days
in advance of the implementation date of any significant proposed
changes in its CMS-approved home infusion therapy accreditation program
and that it agrees not to implement the proposed changes without prior
written notice of continued program approval from CMS, except as
provided for at Sec. 488.1040(b)(2).
(vi) Response to a written notice from CMS. A statement
acknowledging that, in response to a written notice from CMS to the
home infusion therapy accrediting organization of a change in the
applicable home infusion therapy accreditation requirements or survey
process, the organization will provide CMS with proposed corresponding
changes in the accrediting organization's home infusion therapy
accreditation requirements for its CMS-approved home infusion therapy
accreditation program to ensure that its accreditation standards
continue to meet or exceed those of Medicare, or survey process remains
comparable with that of Medicare. The home infusion therapy accrediting
organization must comply with the following requirements:
(A) The proposed changes must be submitted within 30 calendar days
of the date of the written CMS notice to the home infusion therapy
accrediting organization or by a date specified in the notice,
whichever is later. CMS gives due consideration to a home infusion
therapy accrediting organization's request for an extension of the
deadline as long as it is submitted prior to the due date.
(B) The proposed changes are not to be implemented without prior
written notice of continued program approval from CMS, except as
provided for at Sec. 488.1040(b)(2)(ii).
(24) The organization's proposed fees for accreditation, including
any plans for reducing the burden and cost of accreditation to small
and rural suppliers.
(b) Additional information needed. If CMS determines that
additional information is necessary to make a determination for
approval or denial of the home infusion therapy accrediting
organization's initial application or re-application for CMS-approval
of an accreditation program, CMS requires that the home infusion
therapy accrediting organization s submit any specific documentation
requirements and attestations as a condition of approval of
accreditation status. CMS notifies the home infusion therapy
accrediting organization and afford it an opportunity to provide the
additional information.
(c) Withdrawing an application. A home infusion therapy accrediting
organization may withdraw its initial application for CMS' approval of
its home infusion therapy accreditation program at any time before CMS
publishes the final notice described in Sec. 488.1025(b).
(d) Notice of approval or disapproval of application. CMS sends a
notice of its decision to approve or disapprove the home infusion
therapy accrediting organization's application within 210 calendar days
from the date CMS determines the home infusion therapy accrediting
organization's application is complete. The final notice specifies the
following:
(1) The basis for the decision.
(2) The effective date.
(3) The term of the approval (not exceed 6 years).
Sec. 488.1015 Resubmitting a request for reapproval.
(a) Except as provided in paragraph (b) of this section, a home
infusion therapy accrediting organization whose request for CMS's
approval or re-approval of an accreditation program has been denied, or
a home infusion therapy accrediting organization that has voluntarily
withdrawn an initial application, may resubmit its application if the
home infusion therapy accrediting organization satisfies all of the
following requirements:
(1) Revises its home infusion therapy accreditation program to
address the issues related to the denial of its previous request or its
voluntary withdrawal.
(2) Resubmits the application in its entirety.
(b) If a home infusion therapy accrediting organization has
requested, in accordance with Sec. 488.1050, a reconsideration of
CMS's disapproval, it may not submit a new application for approval of
a home infusion therapy accreditation program until such
reconsideration is administratively final.
Sec. 488.1020 Public notice and comment.
CMS publishes a notice in the Federal Register when the following
conditions are met:
(a) Proposed notice. CMS publishes a notice after the receipt of a
completed application from a national home infusion therapy accrediting
organization seeking CMS's approval of a home infusion therapy
accreditation program. The notice identifies the home infusion therapy
accrediting organization, the type of suppliers covered by the home
infusion therapy accreditation program, and provides at least a 30 day
public comment period (beginning on the date of publication).
(b) Final notice. The final notice announces CMS decision to
approve or deny a national accrediting organization application. The
notice specifies the basis for the CMS decision.
(1) Approval or re-approval. If CMS approves or re-approves the
home infusion therapy accrediting organization's home infusion therapy
accreditation program, the final notice at a minimum includes the
following information:
(i) A description of how the home infusion therapy accreditation
program meets or exceeds Medicare home infusion therapy accreditation
program requirements.
(ii) The effective date of approval (no later than the publication
date of the notice).
(iii) The term of the approval (6 years or less).
(2) Denial. If CMS does not approve the home infusion therapy
accrediting organization's accreditation program, the final notice
describes the following:
(i) How the home infusion therapy accrediting organization fails to
meet
[[Page 56635]]
Medicare home infusion therapy accreditation program requirements.
(ii) The effective date of the decision.
Sec. 488.1025 Release and use of home infusion therapy accreditation
surveys.
The home infusion therapy accrediting organization must include, in
its accreditation agreement with each supplier, an acknowledgement that
the supplier agrees to release to CMS a copy of its most current
accreditation survey and any information related to the survey that CMS
may require, corrective action plans.
(a) CMS may determine that a home infusion therapy supplier does
not meet the applicable Medicare conditions or requirements on the
basis of its own investigation of the accreditation survey or any other
information related to the survey.
(b) With the exception of home health agency surveys, general
disclosure of an accrediting organization's survey information is
prohibited under section 1865(b) of the Act. CMS may publically
disclose an accreditation survey and information related to the survey,
upon written request, to the extent that the accreditation survey and
survey information are related to an enforcement action taken by CMS.
Sec. 488.1030 Ongoing review of home infusion therapy accrediting
organizations.
(a) Performance review. CMS evaluates the performance of each CMS-
approved home infusion therapy accreditation program on an ongoing
basis. This review includes the review of the following:
(1) The home infusion therapy accrediting organization's survey
activity.
(2) The home infusion therapy accrediting organization's continued
fulfillment of the requirements at Sec. Sec. 488.1010 and 488.1035.
(b) Comparability review. CMS assesses the equivalency of a home
infusion therapy accrediting organization's CMS-approved program
requirements with the comparable Medicare home infusion therapy
accreditation requirements after CMS imposes new or revised Medicare
accreditation requirements. When this occurs, the following takes
place:
(1) CMS provides the home infusion therapy accrediting
organizations with written notice of the changes to the to the Medicare
home infusion therapy accreditation requirements.
(2) The home infusion therapy accrediting organization must make
revisions to its home infusion therapy accreditation standards or
survey processes which incorporate the new or revised Medicare
accreditation requirements.
(3) In the written notice, CMS specifies the deadline (no less than
30 calendar days) by which the home infusion therapy accrediting
organization must submit its proposed revised home infusion therapy
accreditation standard or survey process revisions, and the
timeframe(s) for implementation of these revised home infusion therapy
accreditation standards.
(4) CMS may extend the submission deadline by which the accrediting
organization must submit its proposed revised home infusion therapy
accreditation standards and survey processes, if both of the following
occur:
(i) The accrediting organization submits a written request for an
extension of the submission deadline.
(ii) The request for extension is submitted prior to the original
submission deadline.
(5) After completing the comparability review of the home infusion
therapy accrediting organizations revised home infusion therapy
accreditation standards and survey processes, CMS shall provide written
notification to the home infusion therapy accrediting organization
regarding whether or not its home infusion therapy accreditation
program, including the proposed revised home infusion therapy
accreditation standards and implementation timeframe(s), continues to
meet or exceed all applicable Medicare requirements.
(6) If, no later than 60 calendar days after receipt of the home
infusion therapy accrediting organization's proposed changes, CMS does
not provide the written notice to the home infusion therapy accrediting
organization required, then the revised home infusion therapy
accreditation standards and program is deemed to meet or exceed all
applicable Medicare requirements and to have continued CMS-approval.
(7) If a home infusion therapy accrediting organization is required
to submit a new application because CMS imposes new home infusion
therapy regulations or makes significant substantive revisions to the
existing home infusion therapy regulations, CMS provides notice of the
decision to approve or disapprove the new application submitted by the
home infusion therapy accrediting organization within the time period
specified in Sec. 488.1010(d).
(8) If a home infusion therapy accrediting organization fails to
submit its proposed changes to its home infusion therapy accreditation
standards and survey processes within the required timeframe, or fails
to implement the proposed changes that have been determined or deemed
by CMS to be comparable, CMS may open an accreditation program review
in accordance with paragraph (d) of this section.
(c) Review of revised home infusion therapy accreditation standards
submitted to CMS by an accrediting organization. When a home infusion
therapy accrediting organization proposes to adopt new or revised
accreditation standards, requirements or changes in its survey process,
the home infusion therapy accrediting organization must do the
following:
(1) Provide CMS with written notice of any proposed changes in home
infusion therapy accreditation standards, requirements or survey
process at least 60 days prior to the proposed implementation date of
the proposed changes.
(2) Not implement any of the proposed changes before receiving
CMS's approval, except as provided in paragraph (c)(4) of this section.
(3) Provide written notice to CMS that includes all of the
following:
(i) A detailed description of the changes that are to be made to
the organization's home infusion therapy accreditation standards,
requirements and survey processes.
(ii) A detailed crosswalk (in table format) that states the exact
language of the organization's revised accreditation requirements and
the applicable Medicare requirements for each.
(4) CMS must provide a written notice to the home infusion therapy
accrediting organization which states whether the home infusion therapy
accreditation program, including the proposed revisions, continues or
does not continue to meet or exceed all applicable Medicare home
infusion therapy requirements within 60 days of receipt of the home
infusion therapy accrediting organization's proposed changes. If CMS
has made a finding that the home infusion therapy accrediting
organization's home infusion therapy accreditation program,
accreditation requirements and survey processes, including the proposed
revisions does not continue to meet or exceed all applicable Medicare
home infusion therapy requirements. CMS must state the reasons for
these findings.
(5) If, no later than 60 calendar days after receipt of the home
infusion therapy accrediting organization's proposed changes, CMS does
not provide written notice to the home infusion therapy accrediting
organization that the home infusion
[[Page 56636]]
therapy accreditation program, including the proposed revisions,
continues or does not continue to meet or exceed all applicable
Medicare home infusion therapy requirements, then the revised home
infusion therapy accreditation program is deemed to meet or exceed all
applicable Medicare home infusion therapy requirements and to have
continued CMS approval.
(6) If a home infusion therapy accrediting organization implements
changes that have neither been determined nor deemed by CMS to be
comparable to the applicable Medicare home infusion therapy
requirements, CMS may open a home infusion therapy accreditation
program review in accordance with paragraph (d) of this section.
(d) CMS-approved home infusion therapy accreditation program
review. If a comparability, performance, or standards review reveals
evidence of substantial non-compliance of a home infusion therapy
accrediting organization's CMS-approved home infusion therapy
accreditation program with the requirements of this subpart, CMS may
initiate a home infusion therapy accreditation program review.
(1) If a home infusion therapy accreditation program review is
initiated, CMS will provide written notice to the home infusion therapy
accrediting organization indicating that its CMS-approved accreditation
program approval may be in jeopardy and that a home infusion therapy
accreditation program review is being initiated. The notice will
provide all of the following information:
(i) A statement of the instances, rates or patterns of non-
compliance identified, as well as other related information, if
applicable.
(ii) A description of the process to be followed during the review,
including a description of the opportunities for the home infusion
therapy accrediting organization to offer factual information related
to CMS' findings.
(iii) A description of the possible actions that may be imposed by
CMS based on the findings of the home infusion therapy accreditation
program review.
(iv) The actions the home infusion therapy accrediting organization
must take to address the identified deficiencies
(v) The length of the accreditation program review probation
period, which will include monitoring of the home infusion therapy
accrediting organization's performance and implementation of the
corrective action plan. The probation period is not to exceed 180
calendar days from the date that CMS approves the AOs corrective action
plan.
(2) CMS will review and approve the home infusion therapy
accrediting organization's plan of correction for acceptability within
30 days after receipt.
(3) CMS will monitor the AO's performance and implementation of the
plan of correction during the probation period which is not to exceed
180 days from the date of approval of the plan of correction.
(4) If CMS determines, as a result of the home infusion therapy
accreditation program review or a review of an application for renewal
of the accrediting organizations existing CMS-approved home infusion
therapy accreditation program, that the home infusion therapy
accrediting organization has failed to meet any of the requirements of
this subpart, CMS may place the home infusion therapy accrediting
organization's CMS-approved home infusion therapy accreditation program
on an additional probation period of up to 180 calendar days subsequent
to the 180-day probation period described in paragraph (d)(1)(v) of
this section to implement additional corrective actions or demonstrate
sustained compliance, not to exceed the home infusion therapy
accrediting organization's current term of approval. In the case of a
renewal application where CMS has already placed the home infusion
therapy accreditation program on probation, CMS indicates that any
approval of the application is conditional while the program is placed
on probation.
(i) Within 60 calendar days after the end of any probationary
period, CMS issues a written determination to the home infusion therapy
accrediting organization as to whether or not its CMS-approved home
infusion therapy accreditation program continues to meet the
requirements of this subpart, including the reasons for the
determination.
(ii) If CMS determines that the home infusion therapy accrediting
organization does not meet the requirements, CMS may withdraw approval
of the CMS-approved home infusion therapy accreditation program. The
notice of determination provided to the home infusion therapy
accrediting organization includes notice of the removal of approval,
reason for the removal, including the effective date determined in
accordance with paragraph (d)(4)(iii) of this section.
(iii) CMS publishes in the Federal Register a notice of its
decision to withdraw approval of a CMS-approved accreditation program,
including the reasons for the withdrawal, effective 60 calendar days
after the date of publication of the notice.
(e) Immediate jeopardy. If at any time CMS determines that the
continued approval of a CMS-approved home infusion therapy
accreditation program of any home infusion therapy accrediting
organization poses an immediate jeopardy to the patients of the
suppliers accredited under the program, or the continued approval
otherwise constitutes a significant hazard to the public health, CMS
may immediately withdraw the approval of a CMS-approved home infusion
therapy accreditation program of that home infusion therapy accrediting
organization and publish a notice of the removal, including the reasons
for it, in the Federal Register.
(f) Notification to home infusion therapy suppliers of withdrawal
of CMS approval status. A home infusion therapy accrediting
organization whose CMS approval of its home infusion therapy
accreditation program has been withdrawn must notify each of its
accredited home infusion therapy suppliers, in writing, of the
withdrawal of CMS approval status no later than 30 calendar days after
the notice is published in the Federal Register. The notification to
the accredited home infusion therapy suppliers must inform them of the
implications for their payment status once their current term of
accreditation expires.
Sec. 488.1035 Ongoing responsibilities of a CMS-approved home
infusion therapy accrediting organization.
A home infusion therapy accreditation organization approved by CMS
must carry out the following activities on an ongoing basis:
(a) Provide CMS with all of the following in written format (either
electronic or hard copy):
(1) Copies of all home infusion therapy accreditation surveys,
together with any survey-related information that CMS may require
(including corrective action plans and summaries of findings with
respect to unmet CMS requirements).
(2) Notice of all accreditation decisions.
(3) Notice of all complaints related to providers or suppliers.
(4) Information about all home infusion therapy accredited
suppliers against which the home infusion therapy accreditation
organization has taken remedial or adverse action, including
revocation, withdrawal, or revision of the providers or suppliers
accreditation.
[[Page 56637]]
(5) The home infusion therapy accrediting organization must
provide, on an annual basis, summary data specified by CMS that relate
to the past year's accreditation activities and trends.
(6) Notice of any proposed changes in the home infusion therapy
accrediting organization's accreditation standards or requirements or
survey process. If the home infusion therapy accrediting organization
implements the changes before or without CMS' approval, CMS may
withdraw its approval of the accrediting organization.
(b) Within 30 calendar days after a change in CMS requirements, the
home infusion therapy accrediting organization must submit an
acknowledgment of receipt of CMS' notification to CMS.
(c) The home infusion therapy accrediting organization must permit
its surveyors to serve as witnesses if CMS takes an adverse action
based on accreditation findings.
(d) Within 2 business days of identifying a deficiency of an
accredited home infusion therapy supplier that poses immediate jeopardy
to a beneficiary or to the general public, the home infusion therapy
accrediting organization must provide CMS with written notice of the
deficiency and any adverse action implemented by the accrediting
organization.
(e) Within 10 calendar days after CMS' notice to a CMS-approved
home infusion therapy accrediting organization that CMS intends to
withdraw approval of the home infusion therapy accrediting
organization, the home infusion therapy accrediting organization must
provide written notice of the withdrawal to all of the home infusion
therapy accrediting organization's accredited suppliers.
Sec. 488.1040 Onsite observations of home infusion therapy
accrediting organization operations.
(a) As part of the application review process, the ongoing review
process, or the continuing oversight of a home infusion therapy
accrediting organization's performance, CMS may conduct onsite
inspections of the home infusion therapy accrediting organization's
operations and offices at any time to verify the home infusion therapy
accrediting organization's representations and to assess the home
infusion therapy accrediting organization's compliance with its own
policies and procedures.
(b) Activities to be performed by CMS staff during the onsite
inspections may include, but are not limited to the following:
(1) Interviews with various accrediting organization staff.
(2) Review of documents, survey files, audit tools, and related
records.
(3) Observation of meetings concerning the home infusion therapy
accreditation process.
(4) Auditing meetings concerning the accreditation process.
(5) Observation of in-progress surveys and audits.
(6) Evaluation of the accrediting organization's survey results and
accreditation decision-making process.
Sec. 488.1045 Voluntary and involuntary termination.
(a) Voluntary termination by a CMS-approved accrediting program. In
accordance with Sec. 488.1010(a)(23), a home infusion therapy
accrediting organization that decides to voluntarily terminate its CMS-
approved home infusion therapy accreditation program must provide
written notice at least 180 days in advance of the effective date of
the termination to CMS and each of its accredited home infusion therapy
suppliers.
(b) Involuntary termination of an accrediting organization's
approval by CMS. Once CMS publishes the notice in the Federal Register
announcing its decision terminate the home infusion therapy accrediting
organization's home infusion therapy accreditation program, the home
infusion therapy accrediting organization must provide written
notification to all suppliers accredited under its CMS-approved home
infusion therapy accreditation program no later than 30 calendar days
after the notice is published in the Federal Register announcing that
CMS is withdrawing its approval of its home infusion therapy
accreditation program and the implications for the home infusion
therapy suppliers payment status in accordance with the requirements at
Sec. 488.1010(f) once their current term of accreditation expires.
(c) Voluntary and involuntary terminations. For both voluntary and
involuntary terminations--
(1) The accreditation status of affected home infusion therapy
suppliers is considered to remain in effect until their current term of
accreditation expires;
(2) If the home infusion therapy supplier wishes to avoid a
suspension of payment, it must provide written notice to CMS at least
60-calendar days prior to its accreditation expiration date that it has
submitted an application for home infusion therapy accreditation under
another CMS-approved home infusion therapy accreditation program.
Failure to comply with this 60-calendar day requirement prior to
expiration of their current home infusion therapy accreditation
stations within could result in a suspension of payment; and
(3) The home infusion therapy accrediting organization provides a
second written notification to all accredited home infusion therapy
suppliers ten calendar days prior to the organization's accreditation
program effective date of termination.
(d) Voluntary withdrawal from accreditation requested by a home
infusion therapy supplier. If a voluntary withdrawal from accreditation
is requested by the home infusion therapy supplier, the withdrawal may
not become effective until the accrediting organization completes all
of the following steps:
(1) The accrediting organization must contact the home infusion
therapy supplier to seek written confirmation that the home infusion
therapy supplier intends to voluntarily withdraw from the home infusion
therapy accreditation program.
(2) The home infusion therapy accrediting organization must advise
the home infusion therapy supplier, in writing, of the statutory
requirement for accreditation for all home infusion therapy suppliers
and the possible payment consequences for a lapse in accreditation
status.
(3) The home infusion therapy accrediting organization must submit
their final notice of the voluntary withdrawal of accreditation by the
home infusion therapy supplier to CMS by 5 business days after the
request for voluntary withdrawal is ultimately processed and effective.
Sec. 488.1050 Reconsideration.
(a) General rule. A home infusion therapy accrediting organization
dissatisfied with a determination that its home infusion therapy
accreditation requirements do not provide or do not continue to provide
reasonable assurance that the suppliers accredited by the home infusion
therapy accrediting organization meet the applicable quality standards
is entitled to reconsideration.
(b) Filing requirements. (1) A written request for reconsideration
must be filed within 30 calendar days of the receipt of CMS notice of
an adverse determination or non-renewal.
(2) The written request for reconsideration must specify the
findings or issues with which the home infusion therapy accrediting
organization disagrees and the reasons for the disagreement.
(3) A requestor may withdraw its written request for
reconsideration at
[[Page 56638]]
any time before the issuance of a reconsideration determination.
(c) CMS response to a request for reconsideration. In response to a
request for reconsideration, CMS provides the accrediting organization
with--
(1) The opportunity for a hearing to be conducted by a hearing
officer appointed by the Administrator of CMS and provide the
accrediting organization the opportunity to present, in writing and in
person, evidence or documentation to refute the determination to deny
approval, or to withdraw or not renew designation; and
(2) Written notice of the time and place of the hearing at least 10
business days before the scheduled date.
(d) Hearing requirements and rules. (1) The reconsideration hearing
is a public hearing open to all of the following:
(i) Authorized representatives and staff from CMS, including, but
not limited to, the following:
(A) Technical advisors (individuals with knowledge of the facts of
the case or presenting interpretation of the facts).
(B) Legal counsel.
(C) Non-technical witnesses with personal knowledge of the facts of
the case.
(ii) Representatives from the accrediting organization requesting
the reconsideration including, but not limited to, the following:
(A) Authorized representatives and staff from the accrediting
organization.
(B) Technical advisors (individuals with knowledge of the facts of
the case or presenting interpretation of the facts).
(C) Legal counsel.
(D) Non-technical witnesses, such as patients and family members
that have personal knowledge of the facts of the case.
(2) The hearing is conducted by the hearing officer who receives
testimony and documents related to the proposed action.
(3) Testimony and other evidence may be accepted by the hearing
officer even though such evidence may be inadmissible under the Federal
Rules of Civil Procedure.
(4) The hearing officer does not have the authority to compel by
subpoena the production of witnesses, papers, or other evidence.
(5) Within 45 calendar days after the close of the hearing, the
hearing officer will present the findings and recommendations to the
accrediting organization that requested the reconsideration.
(6) The written report of the hearing officer will include separate
numbered findings of fact and the legal conclusions of the hearing
officer.
(7) The hearing officer's decision is final.
Dated: October 19, 2018.
Seema Verma,
Administrator, Centers for Medicare and Medicaid Services.
Dated: October 22, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-24145 Filed 10-31-18; 4:15 pm]
BILLING CODE 4120-01-P