Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2020, 17620-17690 [2019-08108]
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Federal Register / Vol. 84, No. 80 / Thursday, April 25, 2019 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 409 and 413
[CMS–1718–P]
RIN 0938–AT75
Medicare Program; Prospective
Payment System and Consolidated
Billing for Skilled Nursing Facilities;
Updates to the Quality Reporting
Program and Value-Based Purchasing
Program for Federal Fiscal Year 2020
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
update the payment rates used under
the prospective payment system (PPS)
for skilled nursing facilities (SNFs) for
fiscal year (FY) 2020. We also propose
minor revisions to the regulation text to
reflect the revised assessment schedule
under Patient Driven Payment Model
(PDPM). Additionally, we propose to
revise the definition of group therapy
under the SNF PPS, and to implement
a subregulatory process for updating the
code lists (International Classification of
Diseases, Tenth Version (ICD–10) codes)
used under PDPM. We are also
soliciting comments on stakeholder
concerns regarding the appropriateness
of the wage index used to adjust SNF
payments. In addition, the proposed
rule includes proposals for the SNF
Quality Reporting Program (QRP) and
the SNF Value-Based Purchasing (VBP)
Program that will affect Medicare
payment to SNFs.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on June 18, 2019.
ADDRESSES: In commenting, please refer
to file code CMS–1718–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://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:
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SUMMARY:
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CMS–1718–P, P.O. Box 8016, Baltimore,
MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–1718–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Penny Gershman, (410) 786–6643, for
information related to SNF PPS clinical
issues.
Anthony Hodge, (410) 786–6645, for
information related to payment for SNFlevel swing-bed services.
John Kane, (410) 786–0557, for
information related to the development
of the payment rates and case-mix
indexes, and general information.
Kia Sidbury, (410) 786–7816, for
information related to the wage index.
Bill Ullman, (410) 786–5667, for
information related to level of care
determinations and consolidated billing.
Casey Freeman, (410) 786–4354, for
information related to skilled nursing
facility quality reporting program.
James Poyer, (410) 786–2261, for
information related to the skilled
nursing facility value-based purchasing
program.
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: https://
www.regulations.gov. Follow the search
instructions on that website to view
public comments.
Availability of Certain Tables
Exclusively Through the Internet on the
CMS Website
As discussed in the FY 2014 SNF PPS
final rule (78 FR 47936), tables setting
forth the Wage Index for Urban Areas
Based on CBSA Labor Market Areas and
the Wage Index Based on CBSA Labor
Market Areas for Rural Areas are no
longer published in the Federal
Register. Instead, these tables are
available exclusively through the
internet on the CMS website. The wage
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index tables for this proposed rule can
be accessed on the SNF PPS Wage Index
home page, at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/WageIndex.html.
Readers who experience any problems
accessing any of these online SNF PPS
wage index tables should contact Kia
Sidbury at (410) 786–7816.
To assist readers in referencing
sections contained in this document, we
are providing the following Table of
Contents.
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of Major Provisions
C. Summary of Cost and Benefits
D. Advancing Health Information Exchange
II. Background on SNF PPS
A. Statutory Basis and Scope
B. Initial Transition for the SNF PPS
C. Required Annual Rate Updates
III. Proposed SNF PPS Rate Setting
Methodology and FY 2020 Update
A. Federal Base Rates
B. SNF Market Basket Update
C. Case-Mix Adjustment
D. Wage Index Adjustment
E. Wage Index Comment Solicitation
F. SNF Value-Based Purchasing Program
G. Adjusted Rate Computation Example
IV. Additional Aspects of the SNF PPS
A. SNF Level of Care—Administrative
Presumption
B. Consolidated Billing
C. Payment for SNF-Level Swing-Bed
Services
V. Issues Relating to PDPM Implementation
A. Revised Group Therapy Definition
B. Updating ICD–10 Code Mappings
C. Revisions to the Regulation Text
VI. Other Issues
A. Skilled Nursing Facility (SNF) Quality
Reporting Program (QRP)
B. Skilled Nursing Facility Value-Based
Purchasing Program (SNF VBP)
VII. Collection of Information Requirements
VIII. Response to Comments
IX. Economic Analyses
Regulations Text
I. Executive Summary
A. Purpose
This proposed rule would update the
SNF prospective payment rates for fiscal
year (FY) 2020 as required under section
1888(e)(4)(E) of the Social Security Act
(the Act). It would also respond to
section 1888(e)(4)(H) of the Act, which
requires the Secretary to provide for
publication in the Federal Register,
before the August 1 that precedes the
start of each FY, certain specified
information relating to the payment
update (see section II.C. of this proposed
rule). This proposed rule also proposes
to revise the definition of group therapy
under the SNF PPS and to implement a
subregulatory process for updating ICD–
10 code lists used under the PDPM.
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Finally, this proposed rule would also
update the Skilled Nursing Facility
Quality Reporting Program (SNF QRP)
and Skilled Nursing Facility ValueBased Purchasing Program (SNF VBP).
B. Summary of Major Provisions
In accordance with sections
1888(e)(4)(E)(ii)(IV) and 1888(e)(5) of
the Act, the federal rates in this
proposed rule would reflect an update
to the rates that we published in the
SNF PPS final rule for FY 2019 (83 FR
39162), as corrected in the FY 2019 SNF
PPS correction notice (83 FR 49832),
which reflects the SNF market basket
update, as adjusted by the multifactor
productivity (MFP) adjustment, for FY
2020. In addition, we are proposing to
revise the definition of group therapy
under the SNF PPS and to implement a
subregulatory process for updating ICD–
10 code lists used under the PDPM.
This proposed rule proposes to
update requirements for the SNF QRP,
including the proposal of two Transfer
of Health Information quality measures
as well as standardized patient
assessment data elements to begin
collection on October 1, 2020 in
satisfaction of the Improving Medicare
Post-Acute Care Transformation Act of
2014 (IMPACT Act) (Pub. L. 113–185,
enacted October 6, 2014). We are also
proposing to exclude baseline nursing
home residents from the Discharge to
Community Measure. In addition, we
are proposing to expand data collection
for SNF QRP quality measures to all
skilled nursing facility residents,
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regardless of their payer. Further, we are
also proposing the public display of the
quality measure, Drug Regimen Review
Conducted With Follow-Up for
Identified Issues- Post Acute Care (PAC)
Skilled Nursing Facility (SNF) Quality
Reporting Program (QRP). We are also
proposing to revise references in
regulation text to reflect enhancements
to the system used for the submission of
data. Finally, we are requesting
information on quality measures and
standardized resident assessment data
elements under consideration for future
years.
In accordance with section 1888(h) of
the Act, this proposed rule would
update certain policies for the SNF VBP.
C. Summary of Cost and Benefits
TABLE 1—COST AND BENEFITS
Provision description
Total transfers
FY 2020 SNF PPS payment rate update .................................................
The overall economic impact of this proposed rule is an estimated increase of $887 million in aggregate payments to SNFs during FY
2020.
The overall economic impact of the SNF VBP Program is an estimated
reduction of $213.6 million in aggregate payments to SNFs during
FY 2020.
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FY 2020 SNF VBP changes ....................................................................
D. Advancing Health Information
Exchange
The Department of Health and Human
Services (HHS) has a number of
initiatives designed to encourage and
support the adoption of interoperable
health information technology and to
promote nationwide health information
exchange to improve health care. The
Office of the National Coordinator for
Health Information Technology (ONC)
and CMS work collaboratively to
advance interoperability across settings
of care, including post-acute care.
To further interoperability in postacute care, we developed a Data
Element Library (DEL) to serve as a
publicly available centralized,
authoritative resource for standardized
data elements and their associated
mappings to health IT standards. The
DEL furthers CMS’ goal of data
standardization and interoperability,
which is also a goal of the Improving
Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT
Act). These interoperable data elements
can reduce provider burden by allowing
the use and exchange of healthcare data,
support provider exchange of electronic
health information for care
coordination, person-centered care, and
support real-time, data driven, clinical
decision making. Standards in the Data
Element Library (https://del.cms.gov/)
can be referenced on the CMS website
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and in the ONC Interoperability
Standards Advisory (ISA). The 2019 ISA
is available at https://www.healthit.gov/
isa.
The 21st Century Cures Act (the Cures
Act) (Pub. L. 114–255, enacted
December 13, 2016) requires HHS to
take new steps to enable the electronic
sharing of health information ensuring
interoperability for providers and
settings across the care continuum. In
another important provision, Congress
defined ‘‘information blocking’’ as
practices likely to interfere with,
prevent, or materially discourage access,
exchange, or use of electronic health
information, and established new
authority for HHS to discourage these
practices. In March 2019, ONC and CMS
published the proposed rules, ‘‘21st
Century Cures Act: Interoperability,
Information Blocking, and the ONC
Health IT Certification Program,’’ (84 FR
7424) and ‘‘Interoperability and Patient
Access’’ (84 FR 7610) to promote secure
and more immediate access to health
information for patients and healthcare
providers through the implementation
of information blocking provisions of
the Cures Act and the use of
standardized application programming
interfaces (APIs) that enable easier
access to electronic health information.
These two proposed rules are open for
public comment at
www.regulations.gov. We invite
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providers to learn more about these
important developments and how they
are likely to affect SNFs.
II. Background on SNF PPS
A. Statutory Basis and Scope
As amended by section 4432 of the
Balanced Budget Act of 1997 (BBA
1997) (Pub. L. 105–33, enacted on
August 5, 1997), section 1888(e) of the
Act provides for the implementation of
a PPS for SNFs. This methodology uses
prospective, case-mix adjusted per diem
payment rates applicable to all covered
SNF services defined in section
1888(e)(2)(A) of the Act. The SNF PPS
is effective for cost reporting periods
beginning on or after July 1, 1998, and
covers all costs of furnishing covered
SNF services (routine, ancillary, and
capital-related costs) other than costs
associated with approved educational
activities and bad debts. Under section
1888(e)(2)(A)(i) of the Act, covered SNF
services include post-hospital extended
care services for which benefits are
provided under Part A, as well as those
items and services (other than a small
number of excluded services, such as
physicians’ services) for which payment
may otherwise be made under Part B
and which are furnished to Medicare
beneficiaries who are residents in a SNF
during a covered Part A stay. A
comprehensive discussion of these
provisions appears in the May 12, 1998
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interim final rule (63 FR 26252). In
addition, a detailed discussion of the
legislative history of the SNF PPS is
available online at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/SNFPPS/
Downloads/Legislative_History_201810-01.pdf.
Section 215(a) of the Protecting
Access to Medicare Act of 2014 (PAMA)
(Pub. L. 113–93, enacted on April 1,
2014) added section 1888(g) to the Act
requiring the Secretary to specify an allcause all-condition hospital readmission
measure and an all-condition riskadjusted potentially preventable
hospital readmission measure for the
SNF setting. Additionally, section
215(b) of PAMA added section 1888(h)
to the Act requiring the Secretary to
implement a VBP program for SNFs.
Finally, section 2(c)(4) of the IMPACT
Act amended section 1888(e)(6) to the
Act, which requires the Secretary to
implement a quality reporting program
for SNFs under which SNFs report data
on measures and resident assessment
data.
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B. Initial Transition for the SNF PPS
Under sections 1888(e)(1)(A) and
1888(e)(11) of the Act, the SNF PPS
included an initial, three-phase
transition that blended a facility-specific
rate (reflecting the individual facility’s
historical cost experience) with the
federal case-mix adjusted rate. The
transition extended through the
facility’s first 3 cost reporting periods
under the PPS, up to and including the
one that began in FY 2001. Thus, the
SNF PPS is no longer operating under
the transition, as all facilities have been
paid at the full federal rate effective
with cost reporting periods beginning in
FY 2002. As we now base payments for
SNFs entirely on the adjusted federal
per diem rates, we no longer include
adjustment factors under the transition
related to facility-specific rates for the
upcoming FY.
C. Required Annual Rate Updates
Section 1888(e)(4)(E) of the Act
requires the SNF PPS payment rates to
be updated annually. The most recent
annual update occurred in a final rule
that set forth updates to the SNF PPS
payment rates for FY 2019 (83 FR
39162), as corrected in the FY 2019 SNF
PPS correction notice (83 FR 49832).
Section 1888(e)(4)(H) of the Act
specifies that we provide for publication
annually in the Federal Register of the
following:
• The unadjusted federal per diem
rates to be applied to days of covered
SNF services furnished during the
upcoming FY.
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• The case-mix classification system
to be applied for these services during
the upcoming FY.
• The factors to be applied in making
the area wage adjustment for these
services.
Along with other revisions discussed
later in this preamble, this proposed
rule will provide the required annual
updates to the per diem payment rates
for SNFs for FY 2020.
III. Proposed SNF PPS Rate Setting
Methodology and FY 2020 Update
A. Federal Base Rates
Under section 1888(e)(4) of the Act,
the SNF PPS uses per diem federal
payment rates based on mean SNF costs
in a base year (FY 1995) updated for
inflation to the first effective period of
the PPS. We developed the federal
payment rates using allowable costs
from hospital-based and freestanding
SNF cost reports for reporting periods
beginning in FY 1995. The data used in
developing the federal rates also
incorporated a Part B add-on, which is
an estimate of the amounts that, prior to
the SNF PPS, would be payable under
Part B for covered SNF services
furnished to individuals during the
course of a covered Part A stay in a SNF.
In developing the rates for the initial
period, we updated costs to the first
effective year of the PPS (the 15-month
period beginning July 1, 1998) using a
SNF market basket index, and then
standardized for geographic variations
in wages and for the costs of facility
differences in case mix. In compiling
the database used to compute the
federal payment rates, we excluded
those providers that received new
provider exemptions from the routine
cost limits, as well as costs related to
payments for exceptions to the routine
cost limits. Using the formula that the
BBA 1997 prescribed, we set the federal
rates at a level equal to the weighted
mean of freestanding costs plus 50
percent of the difference between the
freestanding mean and weighted mean
of all SNF costs (hospital-based and
freestanding) combined. We computed
and applied separately the payment
rates for facilities located in urban and
rural areas, and adjusted the portion of
the federal rate attributable to wagerelated costs by a wage index to reflect
geographic variations in wages.
B. SNF Market Basket Update
1. SNF Market Basket Index
Section 1888(e)(5)(A) of the Act
requires us to establish a SNF market
basket index that reflects changes over
time in the prices of an appropriate mix
of goods and services included in
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covered SNF services. Accordingly, we
have developed a SNF market basket
index that encompasses the most
commonly used cost categories for SNF
routine services, ancillary services, and
capital-related expenses. In the SNF PPS
final rule for FY 2018 (82 FR 36548
through 36566), we revised and rebased
the market basket index, which
included updating the base year from
FY 2010 to 2014.
The SNF market basket index is used
to compute the market basket
percentage change that is used to update
the SNF federal rates on an annual
basis, as required by section
1888(e)(4)(E)(ii)(IV) of the Act. This
market basket percentage update is
adjusted by a forecast error correction,
if applicable, and then further adjusted
by the application of a productivity
adjustment as required by section
1888(e)(5)(B)(ii) of the Act and
described in section III.B.4. of this
proposed rule. For FY 2020, the growth
rate of the 2014-based SNF market
basket is estimated to be 3.0 percent,
based on the IHS Global Insight, Inc.
(IGI) first quarter 2019 forecast with
historical data through fourth quarter
2018, before the multifactor
productivity adjustment is applied.
In section III.B.5. of this proposed
rule, we discuss the 2 percent reduction
applied to the market basket update for
those SNFs that fail to submit measures
data as required by section 1888(e)(6)(A)
of the Act.
2. Use of the SNF Market Basket
Percentage
Section 1888(e)(5)(B) of the Act
defines the SNF market basket
percentage as the percentage change in
the SNF market basket index from the
midpoint of the previous FY to the
midpoint of the current FY. For the
federal rates set forth in this proposed
rule, we use the percentage change in
the SNF market basket index to compute
the update factor for FY 2020. This
factor is based on the FY 2020
percentage increase in the 2014-based
SNF market basket index reflecting
routine, ancillary, and capital-related
expenses. In this proposed rule, the SNF
market basket percentage is estimated to
be 3.0 percent for FY 2020 based on
IGI’s first quarter 2019 forecast (with
historical data through fourth quarter
2018). Finally, as discussed in section
II.B. of this proposed rule, we no longer
compute update factors to adjust a
facility-specific portion of the SNF PPS
rates, because the initial three-phase
transition period from facility-specific
to full federal rates that started with cost
reporting periods beginning in July 1998
has expired.
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3. Forecast Error Adjustment
As discussed in the June 10, 2003
supplemental proposed rule (68 FR
34768) and finalized in the August 4,
2003 final rule (68 FR 46057 through
46059), § 413.337(d)(2) provides for an
adjustment to account for market basket
forecast error. The initial adjustment for
market basket forecast error applied to
the update of the FY 2003 rate for FY
2004, and took into account the
cumulative forecast error for the period
from FY 2000 through FY 2002,
resulting in an increase of 3.26 percent
to the FY 2004 update. Subsequent
adjustments in succeeding FYs take into
account the forecast error from the most
recently available FY for which there is
final data, and apply the difference
between the forecasted and actual
change in the market basket when the
difference exceeds a specified threshold.
We originally used a 0.25 percentage
point threshold for this purpose;
however, for the reasons specified in the
FY 2008 SNF PPS final rule (72 FR
43425, August 3, 2007), we adopted a
0.5 percentage point threshold effective
for FY 2008 and subsequent FYs. As we
stated in the final rule for FY 2004 that
first issued the market basket forecast
error adjustment (68 FR 46058, August
4, 2003), the adjustment will reflect both
upward and downward adjustments, as
appropriate.
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For FY 2018 (the most recently
available FY for which there is final
data), the estimated increase in the
market basket index was 2.6 percentage
points, and the actual increase for FY
2018 is 2.6 percentage points, resulting
in the actual increase being the same as
the estimated increase. Accordingly, as
the difference between the estimated
and actual amount of change in the
market basket index does not exceed the
0.5 percentage point threshold, the FY
2020 market basket percentage change
of 3.0 percent would not be adjusted to
account for the forecast error correction.
Table 2 shows the forecasted and actual
market basket amounts for FY 2018.
TABLE 2—DIFFERENCE BETWEEN THE FORECASTED AND ACTUAL MARKET BASKET INCREASES FOR FY 2018
Index
Forecasted
FY 2018
increase *
Actual
FY 2018
increase **
FY 2018
difference
SNF ..............................................................................................................................................
2.6
2.6
0.0
* Published in Federal Register; based on second quarter 2017 IGI forecast (2010-based index).
** Based on the first quarter 2019 IGI forecast, with historical data through the fourth quarter 2018 (2010-based index).
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4. Multifactor Productivity Adjustment
Section 1888(e)(5)(B)(ii) of the Act, as
added by section 3401(b) of the Patient
Protection and Affordable Care Act
(Affordable Care Act) (Pub. L. 111–148,
enacted on March 23, 2010) requires
that, in FY 2012 and in subsequent FYs,
the market basket percentage under the
SNF payment system (as described in
section 1888(e)(5)(B)(i) of the Act) is to
be reduced annually by the multifactor
productivity (MFP) adjustment
described in section 1886(b)(3)(B)(xi)(II)
of the Act. Section 1886(b)(3)(B)(xi)(II)
of the Act, in turn, defines the MFP
adjustment to be equal to the 10-year
moving average of changes in annual
economy-wide private nonfarm business
multi-factor productivity (as projected
by the Secretary for the 10-year period
ending with the applicable FY, year,
cost-reporting period, or other annual
period). The Bureau of Labor Statistics
(BLS) is the agency that publishes the
official measure of private nonfarm
business MFP. We refer readers to the
BLS website at https://www.bls.gov/mfp
for the BLS historical published MFP
data.
MFP is derived by subtracting the
contribution of labor and capital inputs
growth from output growth. The
projections of the components of MFP
are currently produced by IGI, a
nationally recognized economic
forecasting firm with which CMS
contracts to forecast the components of
the market baskets and MFP. To
generate a forecast of MFP, IGI
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replicates the MFP measure calculated
by the BLS, using a series of proxy
variables derived from IGI’s U.S.
macroeconomic models. For a
discussion of the MFP projection
methodology, we refer readers to the FY
2012 SNF PPS final rule (76 FR 48527
through 48529) and the FY 2016 SNF
PPS final rule (80 FR 46395). A
complete description of the MFP
projection methodology is available on
our website at https://www.cms.gov/
Research-Statistics-Data-and-Systems/
Statistics-Trends-and-Reports/Medicare
ProgramRatesStats/MarketBasket
Research.html.
a. Incorporating the MFP Adjustment
Into the Market Basket Update
Per section 1888(e)(5)(A) of the Act,
the Secretary shall establish a SNF
market basket index that reflects
changes over time in the prices of an
appropriate mix of goods and services
included in covered SNF services.
Section 1888(e)(5)(B)(ii) of the Act,
added by section 3401(b) of the
Affordable Care Act, requires that for FY
2012 and each subsequent FY, after
determining the market basket
percentage described in section
1888(e)(5)(B)(i) of the Act, the Secretary
shall reduce such percentage by the
productivity adjustment described in
section 1886(b)(3)(B)(xi)(II) of the Act
(which we refer to as the MFP
adjustment). Section 1888(e)(5)(B)(ii) of
the Act further states that the reduction
of the market basket percentage by the
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MFP adjustment may result in the
market basket percentage being less than
zero for a FY, and may result in
payment rates under section 1888(e) of
the Act being less than such payment
rates for the preceding fiscal year. Thus,
if the application of the MFP adjustment
to the market basket percentage
calculated under section 1888(e)(5)(B)(i)
of the Act results in an MFP-adjusted
market basket percentage that is less
than zero, then the annual update to the
unadjusted federal per diem rates under
section 1888(e)(4)(E)(ii) of the Act
would be negative, and such rates
would decrease relative to the prior FY.
The MFP adjustment, calculated as
the 10-year moving average of changes
in MFP for the period ending September
30, 2020, is estimated to be 0.5 percent
based on IGI’s first quarter 2019
forecast. Also, consistent with section
1888(e)(5)(B)(i) of the Act and
§ 413.337(d)(2), the market basket
percentage for FY 2020 for the SNF PPS
is based on IGI’s first quarter 2019
forecast of the SNF market basket
percentage, which is estimated to be 3.0
percent. In accordance with section
1888(e)(5)(B)(ii) of the Act and
§ 413.337(d)(3), this market basket
percentage is then reduced by the MFP
adjustment of 0.5 percent. The resulting
MFP-adjusted SNF market basket
update would be equal to 2.5 percent, or
3.0 percent less 0.5 percentage point.
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5. Market Basket Update Factor for FY
2020
Sections 1888(e)(4)(E)(ii)(IV) and
1888(e)(5)(i) of the Act require that the
update factor used to establish the FY
2020 unadjusted federal rates be at a
level equal to the market basket index
percentage change. Accordingly, we
determined the total growth from the
average market basket level for the
period of October 1, 2018, through
September 30, 2019 to the average
market basket level for the period of
October 1, 2019, through September 30,
2020. This process yields a percentage
change in the 2014-based SNF market
basket of 3.0 percent. As further
explained in section III.B.3. of this
proposed rule, as applicable, we adjust
the market basket percentage change by
the forecast error from the most recently
available FY for which there is final
data and apply this adjustment
whenever the difference between the
forecasted and actual percentage change
in the market basket exceeds a 0.5
percentage point threshold. Since the
difference between the forecasted FY
2018 SNF market basket percentage
change and the actual FY 2018 SNF
market basket percentage change (FY
2018 is the most recently available FY
for which there is historical data) did
not exceed the 0.5 percentage point
threshold, the FY 2020 market basket
percentage change of 3.0 percent would
not be adjusted by the forecast error
correction.
Section 1888(e)(5)(B)(ii) of the Act
requires us to reduce the market basket
percentage change by the MFP
adjustment (10-year moving average of
changes in MFP for the period ending
September 30, 2020) of 0.5 percent, as
described in section III.B.4 of this
proposed rule. The resulting net SNF
market basket update would equal 2.5
percent, or 3.0 percent less the 0.5
percentage point MFP adjustment. We
note that our policy has been that, if
more recent data become available (for
example, a more recent estimate of the
SNF market basket and/or MFP
adjustment), we would use such data, if
appropriate, to determine the SNF
market basket percentage change, laborrelated share relative importance,
forecast error adjustment, and MFP
adjustment in the SNF PPS final rule.
We also note that section
1888(e)(6)(A)(i) of the Act provides that,
beginning with FY 2018, SNFs that fail
to submit data, as applicable, in
accordance with sections
1888(e)(6)(B)(i)(II) and (III) of the Act for
a fiscal year will receive a 2.0
percentage point reduction to their
market basket update for the fiscal year
involved, after application of section
1888(e)(5)(B)(ii) of the Act (the MFP
adjustment) and section
1888(e)(5)(B)(iii) of the Act (the 1
percent market basket increase for FY
2018). In addition, section
1888(e)(6)(A)(ii) of the Act states that
application of the 2.0 percentage point
reduction (after application of section
1888(e)(5)(B)(ii) and (iii) of the Act) may
result in the market basket index
percentage change being less than 0.0
for a fiscal year, and may result in
payment rates for a fiscal year being less
than such payment rates for the
preceding fiscal year. Section
1888(e)(6)(A)(iii) of the Act further
specifies that the 2.0 percentage point
reduction is applied in a noncumulative
manner, so that any reduction made
under section 1888(e)(6)(A)(i) of the Act
applies only with respect to the fiscal
year involved, and that the reduction
cannot be taken into account in
computing the payment amount for a
subsequent fiscal year.
Accordingly, for the reasons specified
in this proposed rule, we are proposing
to apply the FY 2020 SNF market basket
increase factor of 2.5 percent in our
determination of the FY 2020 SNF PPS
unadjusted federal per diem rates,
which reflects a market basket increase
factor of 3.0 percent, less the 0.5
percentage point MFP-adjustment.
6. Unadjusted Federal per Diem Rates
for FY 2020
As discussed in the FY 2019 SNF PPS
final rule (83 FR 39162), we are
implementing a new case-mix
classification system to classify SNF
patients under the SNF PPS, beginning
in FY 2020, called the Patient Driven
Payment Model (PDPM). As discussed
in section V.B of that final rule, under
PDPM, the unadjusted Federal per diem
rates are divided into six components,
five of which are case-mix adjusted
components (Physical Therapy (PT),
Occupational Therapy (OT), SpeechLanguage Pathology (SLP), Nursing, and
Non-Therapy Ancillaries (NTA)), and
one of which is a non-case-mix
component, as exists under RUG–IV. In
calculating the FY 2020 unadjusted
Federal per diem rates that would be
used under PDPM in FY 2020, we
applied the FY 2020 MFP-adjusted
market basket increase factor to the
unadjusted Federal per diem rates
provided in Tables 4 and 5 of the FY
2019 SNF PPS final rule (83 FR 39169)
and then applied the methodology for
separating the RUG–IV base rates into
the PDPM base rates, as discussed and
finalized in section V.B.3 of the FY 2019
SNF PPS final rule (83 FR 39191
through 39194).
Tables 3 and 4 reflect the proposed
updated unadjusted federal rates for FY
2020, prior to adjustment for case-mix.
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TABLE 3—FY 2020 UNADJUSTED FEDERAL RATE PER DIEM—URBAN
Rate component
PT
OT
SLP
Nursing
NTA
Non-case-mix
Per Diem Amount ....................................
$61.16
$56.93
$22.83
$106.64
$80.45
$95.48
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TABLE 4—FY 2020 UNADJUSTED FEDERAL RATE PER DIEM—RURAL
Rate component
PT
OT
SLP
Nursing
NTA
Non-case-mix
Per Diem Amount ....................................
$69.72
$64.03
$28.76
$101.88
$76.86
$97.25
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C. Case-Mix Adjustment
Under section 1888(e)(4)(G)(i) of the
Act, the federal rate also incorporates an
adjustment to account for facility casemix, using a classification system that
accounts for the relative resource
utilization of different patient types.
The statute specifies that the adjustment
is to reflect both a resident classification
system that the Secretary establishes to
account for the relative resource use of
different patient types, as well as
resident assessment data and other data
that the Secretary considers appropriate.
In the FY 2019 final rule (83 FR 39162,
August 8, 2018), we finalized a new
case-mix classification model, the
PDPM, to take effect beginning October
1, 2019. The RUG–IV model classifies
most patients into a therapy payment
group and primarily uses the volume of
therapy services provided to the patient
as the basis for payment classification,
thus inadvertently creating an incentive
for SNFs to furnish therapy regardless of
the individual patient’s unique
characteristics, goals, or needs. PDPM
eliminates this incentive and improves
the overall accuracy and
appropriateness of SNF payments by
classifying patients into payment groups
based on specific, data-driven patient
characteristics, while simultaneously
reducing the administrative burden on
SNFs.
The PDPM (like the RUG–IV) uses
clinical data from the MDS to assign
case-mix classifiers to each patient that
are then used to calculate a per diem
payment under the SNF PPS. As
discussed in section IV.A. of this
proposed rule, the clinical orientation of
the case-mix classification system
supports the SNF PPS’s use of an
administrative presumption that
considers a beneficiary’s initial case-mix
classification to assist in making certain
SNF level of care determinations.
Further, because the MDS is used as a
basis for payment, as well as a clinical
assessment, we have provided extensive
training on proper coding and the
timeframes for MDS completion in our
Resident Assessment Instrument (RAI)
Manual. For an MDS to be considered
valid for use in determining payment,
the MDS assessment must be completed
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in compliance with the instructions in
the RAI Manual in effect at the time the
assessment is completed. For payment
and quality monitoring purposes, the
RAI Manual consists of both the Manual
instructions and the interpretive
guidance and policy clarifications
posted on the appropriate MDS website
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
MDS30RAIManual.html.
Under section 1888(e)(4)(H), each
update of the payment rates must
include the case-mix classification
methodology applicable for the
upcoming FY. The FY 2020 payment
rates set forth in this proposed rule
reflect the use of the PDPM case-mix
classification system from October 1,
2019, through September 30, 2020. We
list the proposed case-mix adjusted
PDPM payment rates for FY 2020,
provided separately for urban and rural
SNFs, in Tables 6 and 7 with
corresponding case-mix values.
As discussed in the FY 2019 SNF PPS
final rule (83 FR 39255 through 39256),
we finalized the implementation of
PDPM in a budget neutral manner. To
accomplish this, as discussed in the FY
2019 SNF PPS final rule (83 FR 39256),
the unadjusted PDPM case mix indexes
(CMIs) were multiplied by 1.46 so that
the total estimated payments under the
PDPM would be equal to the total actual
payments under RUG–IV. Further,
section 3.11.2 of the PDPM technical
report, available at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/SNFPPS/
Downloads/PDPM_Technical_Report_
508.pdf, provided additional detail on
the calculation of the PDPM CMIs in
order to achieve budget neutrality. In
that section, it states that ‘‘to align the
distribution of resources across
components with the statutory base
rates, Acumen set CMIs such that the
average product of the CMI and the
variable per diem adjustment factor for
a day of care is the same (set to 1) for
each of the five case-mix-adjusted
components in PDPM. To do this,
Acumen first calculated the product of
the CMI and the adjustment factor for
every utilization day for each
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component. Then, we calculated the
average of this product for each
component. Finally, Acumen calculated
the ratio of 1 divided by the average
product for each component. This ratio
is the standardization multiplier, shown
in Table 65 for each component.’’ As
discussed in section 3.11.2 of the PDPM
Technical Report, the standardization
multiplier is used to align the
distribution of resources across
components with the statutory base
rates by setting the CMIs such that the
average product of the component CMI
and the variable per diem adjustment
factor for that component for a day of
care is the same. Effectively, the
standardization multiplier is used to
mitigate the effect of the variable per
diem adjustment when calculating
budget neutrality. The CMIs were
adjusted such that total payments under
PDPM, if it had been in effect in FY
2017, equal total actual payments made
under RUG–IV in FY 2017.
In this proposed rule, we propose to
update the payment year used as the
basis for the calculation of the
standardization multiplier and budget
neutrality multiplier, in order to best
ensure that PDPM will be implemented
in a budget neutral manner, as finalized
in the FY 2019 SNF PPS final rule. The
only difference in methodology between
that used to calculate these multipliers
and CMIs in the FY 2019 SNF PPS final
rule and that used to calculate the
multipliers and CMIs in this proposed
rule is that, in this proposed rule, we are
updating the data used from FY 2017
data to FY 2018 data. The impact of
using the updated FY 2018 data and the
proposed updated adjustment
multipliers for standardization and
budget neutrality, is provided in Table
5. We would note that while the
multipliers discussed in the FY 2019
SNF PPS final rule and in the PDPM
Technical Report are given to the
hundredths place, in order to make clear
the effect of this change in data, the
multipliers in Table 5 are shown to the
thousandths place. The CMIs provided
in Tables 6 and 7 reflect the use of the
proposed multipliers in Table 5, based
on the update to FY 2018 data.
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TABLE 5—PROPOSED PDPM STANDARDIZATION AND BUDGET NEUTRALITY MULTIPLIERS
FY 2017 data
Component
Standardization
multiplier
PT ............................................................................................
OT ............................................................................................
SLP ..........................................................................................
Nursing .....................................................................................
NTA ..........................................................................................
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Given the differences between RUG–
IV and PDPM in terms of patient
classification and billing, it is important
that the format of Tables 6 and 7 reflect
these differences. More specifically,
under both RUG–IV and PDPM,
providers use a Health Insurance
Prospective Payment System (HIPPS)
code on a claim in order to bill for
covered SNF services. Under RUG–IV,
the HIPPS code includes the three
character RUG–IV group into which the
patient classifies as well as a two
character assessment indicator code that
represents the assessment used to
generate this code. Under PDPM, while
providers would still use a HIPPS code,
the characters in that code represent
different things. For example, the first
character represents the PT and OT
group into which the patient classifies.
If the patient is classified into the PT
and OT group ‘‘TA’’, then the first
character in the patient’s HIPPS code
would be an A. Similarly, if the patient
is classified into the SLP group ‘‘SB’’,
then the second character in the
patient’s HIPPS code would be a B. The
third character represents the Nursing
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Budget
neutrality
multiplier
1.031
1.030
0.995
0.995
0.817
Frm 00008
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Sfmt 4702
Standardization
multiplier
1.458
1.458
1.458
1.458
1.458
group into which the patient classifies.
The fourth character represents the NTA
group into which the patient classifies.
Finally, the fifth character represents
the assessment used to generate the
HIPPS code.
Therefore, we have modified the
format of Tables 6 and 7 from what we
have used for similar tables in prior SNF
PPS rulemaking, such as Tables 6 and
7 of the FY 2019 SNF PPS final rule (83
FR 39170 through 39172). Column 1 of
Tables 6 and 7 represents the character
in the HIPPS code associated with a
given PDPM component. Columns 2 and
3 provide the case-mix index and
associated case-mix adjusted component
rate, respectively, for the relevant PT
group. Columns 4 and 5 provide the
case-mix index and associated case-mix
adjusted component rate, respectively,
for the relevant OT group. Columns 6
and 7 provide the case-mix index and
associated case-mix adjusted component
rate, respectively, for the relevant SLP
group. Column 8 provides the nursing
case-mix group (CMG) that is connected
with a given PDPM HIPPS character. For
example, if the patient qualified for the
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FY 2018 data
1.028
1.028
0.996
0.996
0.811
Budget
neutrality
multiplier
1.463
1.463
1.463
1.463
1.463
nursing group CBC1, then the third
character in the patient’s HIPPS code
would be a ‘‘P.’’ Columns 9 and 10
provide the case-mix index and
associated case-mix adjusted component
rate, respectively, for the relevant
nursing group. Finally, columns 11 and
12 provide the case-mix index and
associated case-mix adjusted component
rate, respectively, for the relevant NTA
group. Tables 6 and 7 do not reflect
adjustments which may be made to the
SNF PPS rates as a result of either the
SNF QRP, discussed in section VI.B. of
this proposed rule, or the SNF VBP
program, discussed in sections III.B.5.
and VI.C. of this proposed rule, or other
adjustments, such as the variable per
diem adjustment. Further, we use the
revised OMB delineations adopted in
the FY 2015 SNF PPS final rule (79 FR
45632, 45634), with updates as reflected
in OMB Bulletin Nos, 15–01 and 17–01,
to identify a facility’s urban or rural
status for the purpose of determining
which set of rate tables would apply to
the facility.
BILLING CODE 4120–01–P
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TABLE 6: PDPM Case-Mix Adjusted Federal Rates and Associated Indexes--URBAN
PT
CMI
Rate
OT
CMI
Rate
A
B
1.53
1.70
1.88
1.92
1.42
1.61
1.67
1.16
1.13
1.42
1.52
1.09
1.27
1.48
1.55
1.08
$93.57
$103.97
$114.98
$117.43
$86.85
$98.47
$102.14
$70.95
$69.11
$86.85
$92.96
$66.66
$77.67
$90.52
$94.80
$66.05
1.49
1.63
1.69
1.53
1.41
1.60
1.64
1.15
1.18
1.45
1.54
1.11
1.30
1.50
1.55
1.09
$84.83
$92.80
$96.21
$87.10
$80.27
$91.09
$93.37
$65.47
$67.18
$82.55
$87.67
$63.19
$74.01
$85.40
$88.24
$62.05
-
-
-
-
c
D
E
F
G
H
I
J
K
L
M
N
0
p
Q
R
s
T
u
v
w
X
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y
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OT
PO 00000
SLP
CMI
Rate
0.68
1.82
2.67
1.46
2.34
2.98
2.04
2.86
3.53
2.99
3.70
4.21
$15.52
$41.55
$60.96
$33.33
$53.42
$68.03
$46.57
$65.29
$80.59
$68.26
$84.47
$96.11
-
-
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Nursing
CMG
Nursing
CMI
Nursing
ES3
ES2
ESl
HDE2
HDEl
HBC2
HBCl
LDE2
LDEl
LBC2
LBCl
CDE2
CDEl
CBC2
CA2
CBCl
CAl
BAB2
BABl
PDE2
PDEl
PBC2
PA2
PBCl
PAl
4.06
3.07
2.93
2.40
1.99
2.24
1.86
2.08
1.73
1.72
1.43
1.87
1.62
1.55
1.09
1.34
0.94
1.04
0.99
1.57
1.47
1.22
0.71
1.13
0.66
$432.96
$327.38
$312.46
$255.94
$212.21
$238.87
$198.35
$221.81
$184.49
$183.42
$152.50
$199.42
$172.76
$165.29
$116.24
$142.90
$100.24
$110.91
$105.57
$167.42
$156.76
$130.10
$75.71
$120.50
$70.38
Sfmt 4725
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Rate
25APP3
NTA
CMI
NTA
3.24
2.53
1.84
1.33
0.96
0.72
$260.66
$203.54
$148.03
$107.00
$77.23
$57.92
-
-
Rate
EP25AP19.004</GPH>
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D. Wage Index Adjustment
Section 1888(e)(4)(G)(ii) of the Act
requires that we adjust the federal rates
to account for differences in area wage
levels, using a wage index that the
Secretary determines appropriate. Since
the inception of the SNF PPS, we have
used hospital inpatient wage data in
developing a wage index to be applied
to SNFs. We propose to continue this
practice for FY 2020, as we continue to
believe that in the absence of SNFspecific wage data, using the hospital
inpatient wage index data is appropriate
and reasonable for the SNF PPS. As
explained in the update notice for FY
2005 (69 FR 45786), the SNF PPS does
not use the hospital area wage index’s
occupational mix adjustment, as this
adjustment serves specifically to define
the occupational categories more clearly
in a hospital setting; moreover, the
collection of the occupational wage data
also excludes any wage data related to
SNFs. Therefore, we believe that using
the updated wage data exclusive of the
occupational mix adjustment continues
to be appropriate for SNF payments. As
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in previous years, we would continue to
use the pre-reclassified IPPS hospital
wage data, unadjusted for occupational
mix and the rural floor, as the basis for
the SNF PPS wage index. For FY 2020,
the updated wage data are for hospital
cost reporting periods beginning on or
after October 1, 2015 and before October
1, 2016 (FY 2016 cost report data).
We note that section 315 of the
Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection
Act of 2000 (BIPA) (Pub. L. 106–554,
enacted on December 21, 2000)
authorized us to establish a geographic
reclassification procedure that is
specific to SNFs, but only after
collecting the data necessary to establish
a SNF PPS wage index that is based on
wage data from nursing homes.
However, to date, this has proven to be
unfeasible due to the volatility of
existing SNF wage data and the
significant amount of resources that
would be required to improve the
quality of that data. More specifically,
auditing all SNF cost reports, similar to
the process used to audit inpatient
hospital cost reports for purposes of the
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Inpatient Prospective Payment System
(IPPS) wage index, would place a
burden on providers in terms of
recordkeeping and completion of the
cost report worksheet. As discussed in
greater detail later in this section,
adopting such an approach would
require a significant commitment of
resources by CMS and the Medicare
Administrative Contractors, potentially
far in excess of those required under the
IPPS given that there are nearly five
times as many SNFs as there are
inpatient hospitals. Therefore, while we
continue to believe that the
development of such an audit process
could improve SNF cost reports in such
a manner as to permit us to establish a
SNF-specific wage index, we do not
regard an undertaking of this magnitude
as being feasible within the current level
of programmatic resources.
In addition, we propose to continue to
use the same methodology discussed in
the SNF PPS final rule for FY 2008 (72
FR 43423) to address those geographic
areas in which there are no hospitals,
and thus, no hospital wage index data
on which to base the calculation of the
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FY 2019 SNF PPS wage index. For rural
geographic areas that do not have
hospitals, and therefore, lack hospital
wage data on which to base an area
wage adjustment, we would use the
average wage index from all contiguous
Core-Based Statistical Areas (CBSAs) as
a reasonable proxy. For FY 2020, there
are no rural geographic areas that do not
have hospitals, and thus, this
methodology would not be applied. For
rural Puerto Rico, we would not apply
this methodology due to the distinct
economic circumstances that exist there
(for example, due to the close proximity
to one another of almost all of Puerto
Rico’s various urban and non-urban
areas, this methodology would produce
a wage index for rural Puerto Rico that
is higher than that in half of its urban
areas); instead, we would continue to
use the most recent wage index
previously available for that area. For
urban areas without specific hospital
wage index data, we would use the
average wage indexes of all of the urban
areas within the state to serve as a
reasonable proxy for the wage index of
that urban CBSA. For FY 2020, the only
urban area without wage index data
available is CBSA 25980, HinesvilleFort Stewart, GA. The final wage index
applicable to FY 2020 is set forth in
Tables A and B available on the CMS
website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/WageIndex.html.
In the SNF PPS final rule for FY 2006
(70 FR 45026, August 4, 2005), we
adopted the changes discussed in OMB
Bulletin No. 03–04 (June 6, 2003),
which announced revised definitions
for MSAs and the creation of
micropolitan statistical areas and
combined statistical areas. In adopting
the CBSA geographic designations, we
provided for a 1-year transition in FY
2006 with a blended wage index for all
providers. For FY 2006, the wage index
for each provider consisted of a blend of
50 percent of the FY 2006 MSA-based
wage index and 50 percent of the FY
2006 CBSA-based wage index (both
using FY 2002 hospital data). We
referred to the blended wage index as
the FY 2006 SNF PPS transition wage
index. As discussed in the SNF PPS
final rule for FY 2006 (70 FR 45041),
since the expiration of this 1-year
transition on September 30, 2006, we
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have used the full CBSA-based wage
index values.
In the FY 2015 SNF PPS final rule (79
FR 45644 through 45646), we finalized
changes to the SNF PPS wage index
based on the newest OMB delineations,
as described in OMB Bulletin No. 13–
01, beginning in FY 2015, including a 1year transition with a blended wage
index for FY 2015. OMB Bulletin No.
13–01 established revised delineations
for Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and
Combined Statistical Areas in the
United States and Puerto Rico based on
the 2010 Census, and provided guidance
on the use of the delineations of these
statistical areas using standards
published on June 28, 2010 in the
Federal Register (75 FR 37246 through
37252). Subsequently, on July 15, 2015,
OMB issued OMB Bulletin No. 15–01,
which provides minor updates to and
supersedes OMB Bulletin No. 13–01
that was issued on February 28, 2013.
The attachment to OMB Bulletin No.
15–01 provides detailed information on
the update to statistical areas since
February 28, 2013. The updates
provided in OMB Bulletin No. 15–01 are
based on the application of the 2010
Standards for Delineating Metropolitan
and Micropolitan Statistical Areas to
Census Bureau population estimates for
July 1, 2012 and July 1, 2013. In
addition, on August 15, 2017, OMB
issued Bulletin No. 17–01 which
announced a new urban CBSA, Twin
Falls, Idaho (CBSA 46300). As we
previously stated in the FY 2008 SNF
PPS proposed and final rules (72 FR
25538 through 25539, and 72 FR 43423),
we wish to note that this and all
subsequent SNF PPS rules and notices
are considered to incorporate any
updates and revisions set forth in the
most recent OMB bulletin that applies
to the hospital wage data used to
determine the current SNF PPS wage
index.
Once calculated, we would apply the
wage index adjustment to the laborrelated portion of the federal rate. Each
year, we calculate a revised laborrelated share, based on the relative
importance of labor-related cost
categories (that is, those cost categories
that are labor-intensive and vary with
the local labor market) in the input price
index. In the SNF PPS final rule for FY
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2018 (82 FR 36548 through 36566), we
finalized a proposal to revise the laborrelated share to reflect the relative
importance of the 2014-based SNF
market basket cost weights for the
following cost categories: Wages and
Salaries; Employee Benefits;
Professional Fees: Labor-Related;
Administrative and Facilities Support
Services; Installation, Maintenance, and
Repair Services; All Other: LaborRelated Services; and a proportion of
Capital-Related expenses.
We calculate the labor-related relative
importance from the SNF market basket,
and it approximates the labor-related
portion of the total costs after taking
into account historical and projected
price changes between the base year and
FY 2020. The price proxies that move
the different cost categories in the
market basket do not necessarily change
at the same rate, and the relative
importance captures these changes.
Accordingly, the relative importance
figure more closely reflects the cost
share weights for FY 2020 than the base
year weights from the SNF market
basket.
We calculate the labor-related relative
importance for FY 2020 in four steps.
First, we compute the FY 2020 price
index level for the total market basket
and each cost category of the market
basket. Second, we calculate a ratio for
each cost category by dividing the FY
2020 price index level for that cost
category by the total market basket price
index level. Third, we determine the FY
2020 relative importance for each cost
category by multiplying this ratio by the
base year (2014) weight. Finally, we add
the FY 2020 relative importance for
each of the labor-related cost categories
(Wages and Salaries, Employee Benefits,
Professional Fees: Labor-Related,
Administrative and Facilities Support
Services, Installation, Maintenance, and
Repair Services, All Other: Labor-related
services, and a portion of CapitalRelated expenses) to produce the FY
2020 labor-related relative importance.
Table 8 summarizes the proposed laborrelated share for FY 2020, based on IGI’s
first quarter 2019 forecast with
historical data through fourth quarter
2018, compared to the labor-related
share that was used for the FY 2019 SNF
PPS final rule.
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TABLE 8—LABOR-RELATED RELATIVE IMPORTANCE, FY 2019 AND FY 2020
Relative
importance,
labor-related,
FY 2019
18:2 forecast 1
Relative
importance,
labor-related,
FY 2020
19:1 forecast 2
Wages and salaries .....................................................................................................................................
Employee benefits .......................................................................................................................................
Professional Fees: Labor-Related ...............................................................................................................
Administrative and facilities support services ..............................................................................................
Installation, Maintenance and Repair Services ...........................................................................................
All Other: Labor Related Services ...............................................................................................................
Capital-related (.391) ...................................................................................................................................
50.2
10.1
3.7
0.5
0.6
2.5
2.9
50.6
10.0
3.7
0.5
0.6
2.5
2.9
Total ......................................................................................................................................................
70.5
70.8
1 Published
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2 Based
in the Federal Register; based on second quarter 2018 IGI forecast.
on first quarter 2019 IGI forecast, with historical data through fourth quarter 2018.
In order to calculate the labor portion
of the case-mix adjusted per diem rate,
one would multiply the total case-mix
adjusted per diem rate, which is the
sum of all five case-mix adjusted
components into which a patient
classifies, and the non-case-mix
component rate, by the FY 2020 laborrelated share percentage provided in
Table 8. The remaining portion of the
rate would be the non-labor portion. In
prior years, we have included tables
which provide the case-mix adjusted
RUG–IV rates, by RUG–IV group, broken
out by total rate, labor portion and nonlabor portion, such as Table 9 of the FY
2019 SNF PPS final rule (83 FR 39175).
However, under PDPM, as the total rate
is calculated as a combination of six
different component rates, five of which
are case-mix adjusted, and given the
sheer volume of possible combinations
of these five case-mix adjusted
components, it is not feasible to provide
tables similar to those that have existed
in prior rulemaking.
Therefore, to aid stakeholders in
understanding the effect of the wage
index on the calculation of the SNF per
diem rate, we have included a revised
hypothetical rate calculation in Table 9.
Section 1888(e)(4)(G)(ii) of the Act
also requires that we apply this wage
index in a manner that does not result
in aggregate payments under the SNF
PPS that are greater or less than would
otherwise be made if the wage
adjustment had not been made. For FY
2020 (federal rates effective October 1,
2019), we would apply an adjustment to
fulfill the budget neutrality requirement.
We would meet this requirement by
multiplying each of the components of
the unadjusted federal rates by a budget
neutrality factor equal to the ratio of the
weighted average wage adjustment
factor for FY 2019 to the weighted
average wage adjustment factor for FY
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2020. For this calculation, we would use
the same FY 2018 claims utilization
data for both the numerator and
denominator of this ratio. We define the
wage adjustment factor used in this
calculation as the labor share of the rate
component multiplied by the wage
index plus the non-labor share of the
rate component. The proposed budget
neutrality factor for FY 2020 would be
1.0060.
E. Wage Index Comment Solicitation
As discussed above, historically, we
have calculated the SNF PPS wage
index values using unadjusted wage
index values from another provider
setting. Stakeholders have frequently
commented on certain aspects of the
SNF PPS wage index values and their
impact on payments. We are soliciting
comments on concerns stakeholders
may have regarding the wage index used
to adjust SNF PPS payments and
suggestions for possible updates and
improvements to the geographic
adjustment of SNF PPS payments.
F. SNF Value-Based Purchasing
Program
Beginning with payment for services
furnished on October 1, 2018, section
1888(h) of the Act requires the Secretary
to reduce the adjusted Federal per diem
rate determined under section
1888(e)(4)(G) of the Act otherwise
applicable to a SNF for services
furnished during a fiscal year by 2
percent, and to adjust the resulting rate
for a SNF by the value-based incentive
payment amount earned by the SNF
based on the SNF’s performance score
for that fiscal year under the SNF VBP
Program. To implement these
requirements, we finalized in the FY
2019 SNF PPS final rule the addition of
§ 413.337(f) to our regulations (83 FR
39178).
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Please see section VI.B. of this
proposed rule for a discussion of our
proposals for the SNF VBP Program.
G. Adjusted Rate Computation Example
The following series of tables
provides an example of how payment
would be calculated during FY 2020
under PDPM for a hypothetical 30 day
SNF stay, involving the hypothetical
SNF XYZ, located in Frederick, MD
(Urban CBSA 43524), for a hypothetical
patient who is classified into such
groups that the patient’s HIPPS code is
NHNC1. Table 9 shows the adjustments
made to the federal per diem rates (prior
to application of any adjustments under
the SNF QRP and SNF VBP programs as
discussed above) to compute the
provider’s case-mix adjusted per diem
rate for FY 2020, based on the patient’s
PDPM classification, as well as how the
VPD adjustment factor affects
calculation of the per diem rate for a
given day of the stay. Table 10 shows
the adjustments made to the case-mix
adjusted per diem rate from Table 9 to
account for the provider’s wage index.
The wage index used in this example is
based on the FY 2020 SNF PPS wage
index that appears in Table A available
on the CMS website at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/SNFPPS/
WageIndex.html. Finally, Table 11
provides the case-mix and wage index
adjusted per-diem rate for this patient
for each day of the 30-day stay, as well
as the total payment for this stay. Table
11 also includes the variable per diem
(VPD) adjustment factors for each day of
the patient’s stay, to clarify why the
patient’s per diem rate changes for
certain days of the stay. As illustrated in
Table 11, SNF XYZ’s total PPS payment
for this particular patient’s stay would
equal $19,992.80.
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TABLE 9—PDPM CASE-MIX ADJUSTED RATE COMPUTATION EXAMPLE
[Per diem rate calculation]
Component
rate
VPD
adjustment
factor
VPD
adjustment
rate
Component
Component group
PT ....................................................................
OT ...................................................................
SLP .................................................................
Nursing ............................................................
NTA .................................................................
Non-Case-Mix .................................................
TN ...................................................................
TN ...................................................................
SH ..................................................................
CBC2 ..............................................................
NC ..................................................................
.........................................................................
$90.52
85.40
65.29
165.29
148.03
95.48
1.00
1.00
........................
........................
3.00
........................
$90.52
85.40
65.29
165.29
444.09
95.48
Total PDPM Case-Mix Adj. Per Diem .....
.........................................................................
........................
........................
946.07
TABLE 10—WAGE INDEX ADJUSTED RATE COMPUTATION EXAMPLE
[PDPM wage index adjustment calculation]
HIPPS code
PDPM
case-mix
adjusted
per diem
Labor
portion
Wage index
Wage index
adjusted rate
Non-labor
portion
Total
case mix and
wage index
adj. rate
NHNC1 .....................................................
$946.07
$669.82
0.9757
$653.54
$276.25
$929.79
PT/OT VPD
adjustment
factor
Case mix and
wage index
adjusted per
diem rate
TABLE 11—ADJUSTED RATE COMPUTATION EXAMPLE
NTA VPD
adjustment
factor
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Day of stay
1 ...................................................................................................................................................
2 ...................................................................................................................................................
3 ...................................................................................................................................................
4 ...................................................................................................................................................
5 ...................................................................................................................................................
6 ...................................................................................................................................................
7 ...................................................................................................................................................
8 ...................................................................................................................................................
9 ...................................................................................................................................................
10 .................................................................................................................................................
11 .................................................................................................................................................
12 .................................................................................................................................................
13 .................................................................................................................................................
14 .................................................................................................................................................
15 .................................................................................................................................................
16 .................................................................................................................................................
17 .................................................................................................................................................
18 .................................................................................................................................................
19 .................................................................................................................................................
20 .................................................................................................................................................
21 .................................................................................................................................................
22 .................................................................................................................................................
23 .................................................................................................................................................
24 .................................................................................................................................................
25 .................................................................................................................................................
26 .................................................................................................................................................
27 .................................................................................................................................................
28 .................................................................................................................................................
29 .................................................................................................................................................
30 .................................................................................................................................................
3.0
3.0
3.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
0.98
0.98
0.98
0.98
0.98
0.98
0.98
0.96
0.96
0.96
$929.79
929.79
929.79
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
638.83
635.37
635.37
635.37
635.37
635.37
635.37
635.37
631.91
631.91
631.91
Total Payment ......................................................................................................................
........................
........................
19,992.80
IV. Additional Aspects of the SNF PPS
A. SNF Level of Care—Administrative
Presumption
The establishment of the SNF PPS did
not change Medicare’s fundamental
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requirements for SNF coverage.
However, because the case-mix
classification is based, in part, on the
beneficiary’s need for skilled nursing
care and therapy, we have attempted,
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where possible, to coordinate claims
review procedures with the existing
resident assessment process and casemix classification system discussed in
section III.C. of this proposed rule. This
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approach includes an administrative
presumption that utilizes a beneficiary’s
correct assignment, at the outset of the
SNF stay, to one of the case-mix
classifiers designated for this purpose to
assist in making certain SNF level of
care determinations.
In accordance with the regulations at
§ 413.345, we include in each update of
the federal payment rates in the Federal
Register a discussion of the resident
classification system that provides the
basis for case-mix adjustment. Under
that discussion, we designate those
specific classifiers under the case-mix
classification system that represent the
required SNF level of care, as provided
in § 409.30. This designation reflects an
administrative presumption that those
beneficiaries who are correctly assigned
one of the designated case-mix
classifiers on the 5-day Medicarerequired assessment are automatically
classified as meeting the SNF level of
care definition up to and including the
assessment reference date (ARD) for that
assessment.
A beneficiary who does not qualify for
the presumption is not automatically
classified as either meeting or not
meeting the level of care definition, but
instead receives an individual
determination on this point using the
existing administrative criteria. This
presumption recognizes the strong
likelihood that those beneficiaries who
are assigned one of the designated casemix classifiers during the immediate
post-hospital period would require a
covered level of care, which would be
less likely for other beneficiaries.
In the July 30, 1999 final rule (64 FR
41670), we indicated that we would
announce any changes to the guidelines
for Medicare level of care
determinations related to modifications
in the case-mix classification structure.
The FY 2018 final rule (82 FR 36544)
further specified that we would
henceforth disseminate the standard
description of the administrative
presumption’s designated groups via the
SNF PPS website at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/SNFPPS/
index.html (where such designations
appear in the paragraph entitled ‘‘Case
Mix Adjustment’’), and would publish
such designations in rulemaking only to
the extent that we actually intend to
make changes in them. Under that
approach, the set of case-mix classifiers
designated for this purpose under PDPM
was finalized in the FY 2019 SNF PPS
final rule (83 FR 39253) and is posted
on the SNF PPS website (https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/SNFPPS/
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index.html), in the paragraph entitled
‘‘Case Mix Adjustment.’’
However, we note that this
administrative presumption policy does
not supersede the SNF’s responsibility
to ensure that its decisions relating to
level of care are appropriate and timely,
including a review to confirm that any
services prompting the assignment of
one of the designated case-mix
classifiers (which, in turn, serves to
trigger the administrative presumption)
are themselves medically necessary. As
we explained in the FY 2000 SNF PPS
final rule (64 FR 41667), the
administrative presumption is itself
rebuttable in those individual cases in
which the services actually received by
the resident do not meet the basic
statutory criterion of being reasonable
and necessary to diagnose or treat a
beneficiary’s condition (according to
section 1862(a)(1) of the Act).
Accordingly, the presumption would
not apply, for example, in those
situations where the sole classifier that
triggers the presumption is itself
assigned through the receipt of services
that are subsequently determined to be
not reasonable and necessary. Moreover,
we want to stress the importance of
careful monitoring for changes in each
patient’s condition to determine the
continuing need for Part A SNF benefits
after the ARD of the 5-day assessment.
Finally, regarding the new set of casemix classifiers designated under the
PDPM for this purpose, we noted in the
FY 2019 SNF PPS final rule (83 FR
39253, August 8, 2018) our intent ‘‘. . .
to review the new designations going
forward and make further adjustments
over time as we gain actual operating
experience under the new classification
model.’’ Accordingly, to the extent that
it may become evident in actual practice
that these new criteria are not accurately
performing their intended role (for
example, by capturing cases that do not
actually require an SNF level of care),
we would propose appropriate
adjustments to correct them.
B. Consolidated Billing
Sections 1842(b)(6)(E) and 1862(a)(18)
of the Act (as added by section 4432(b)
of the BBA 1997) require a SNF to
submit consolidated Medicare bills to
its Medicare Administrative Contractor
(MAC) for almost all of the services that
its residents receive during the course of
a covered Part A stay. In addition,
section 1862(a)(18) of the Act places the
responsibility with the SNF for billing
Medicare for physical therapy,
occupational therapy, and speechlanguage pathology services that the
resident receives during a noncovered
stay. Section 1888(e)(2)(A) of the Act
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excludes a small list of services from the
consolidated billing provision
(primarily those services furnished by
physicians and certain other types of
practitioners), which remain separately
billable under Part B when furnished to
a SNF’s Part A resident. These excluded
service categories are discussed in
greater detail in section V.B.2. of the
May 12, 1998 interim final rule (63 FR
26295 through 26297).
A detailed discussion of the
legislative history of the consolidated
billing provision is available on the SNF
PPS website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/Downloads/
Legislative_History_2018-10-01.pdf. In
particular, section 103 of the Medicare,
Medicaid, and SCHIP Balanced Budget
Refinement Act of 1999 (BBRA, Pub. L.
106–113, enacted on November 29,
1999) amended section 1888(e)(2)(A) of
the Act by further excluding a number
of individual high-cost, low probability
services, identified by Healthcare
Common Procedure Coding System
(HCPCS) codes, within several broader
categories (chemotherapy items,
chemotherapy administration services,
radioisotope services, and customized
prosthetic devices) that otherwise
remained subject to the provision. We
discuss this BBRA amendment in
greater detail in the SNF PPS proposed
and final rules for FY 2001 (65 FR 19231
through 19232, April 10, 2000, and 65
FR 46790 through 46795, July 31, 2000),
as well as in Program Memorandum
AB–00–18 (Change Request #1070),
issued March 2000, which is available
online at www.cms.gov/transmittals/
downloads/ab001860.pdf.
As explained in the FY 2001 proposed
rule (65 FR 19232), the amendments
enacted in section 103 of the BBRA not
only identified for exclusion from this
provision a number of particular service
codes within four specified categories
(that is, chemotherapy items,
chemotherapy administration services,
radioisotope services, and customized
prosthetic devices), but also gave the
Secretary the authority to designate
additional, individual services for
exclusion within each of the specified
service categories. In the proposed rule
for FY 2001, we also noted that the
BBRA Conference report (H.R. Rep. No.
106–479 at 854 (1999) (Conf. Rep.))
characterizes the individual services
that this legislation targets for exclusion
as high-cost, low probability events that
could have devastating financial
impacts because their costs far exceed
the payment SNFs receive under the
PPS. According to the conferees, section
103(a) of the BBRA is an attempt to
exclude from the PPS certain services
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and costly items that are provided
infrequently in SNFs. By contrast, the
amendments enacted in section 103 of
the BBRA do not designate for exclusion
any of the remaining services within
those four categories (thus, leaving all of
those services subject to SNF
consolidated billing), because they are
relatively inexpensive and are furnished
routinely in SNFs.
As we further explained in the final
rule for FY 2001 (65 FR 46790), and as
is consistent with our longstanding
policy, any additional service codes that
we might designate for exclusion under
our discretionary authority must meet
the same statutory criteria used in
identifying the original codes excluded
from consolidated billing under section
103(a) of the BBRA: they must fall
within one of the four service categories
specified in the BBRA; and they also
must meet the same standards of high
cost and low probability in the SNF
setting, as discussed in the BBRA
Conference report. Accordingly, we
characterized this statutory authority to
identify additional service codes for
exclusion as essentially affording the
flexibility to revise the list of excluded
codes in response to changes of major
significance that may occur over time
(for example, the development of new
medical technologies or other advances
in the state of medical practice) (65 FR
46791). In this proposed rule, we
specifically invite public comments
identifying HCPCS codes in any of these
four service categories (chemotherapy
items, chemotherapy administration
services, radioisotope services, and
customized prosthetic devices)
representing recent medical advances
that might meet our criteria for
exclusion from SNF consolidated
billing. We may consider excluding a
particular service if it meets our criteria
for exclusion as specified above.
Commenters should identify in their
comments the specific HCPCS code that
is associated with the service in
question, as well as their rationale for
requesting that the identified HCPCS
code(s) be excluded.
We note that the original BBRA
amendment (as well as the
implementing regulations) identified a
set of excluded services by means of
specifying HCPCS codes that were in
effect as of a particular date (in that
case, as of July 1, 1999). Identifying the
excluded services in this manner made
it possible for us to utilize program
issuances as the vehicle for
accomplishing routine updates of the
excluded codes, to reflect any minor
revisions that might subsequently occur
in the coding system itself (for example,
the assignment of a different code
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number to the same service).
Accordingly, in the event that we
identify through the current rulemaking
cycle any new services that would
actually represent a substantive change
in the scope of the exclusions from SNF
consolidated billing, we would identify
these additional excluded services by
means of the HCPCS codes that are in
effect as of a specific date (in this case,
as of October 1, 2019). By making any
new exclusions in this manner, we
could similarly accomplish routine
future updates of these additional codes
through the issuance of program
instructions.
C. Payment for SNF-Level Swing-Bed
Services
Section 1883 of the Act permits
certain small, rural hospitals to enter
into a Medicare swing-bed agreement,
under which the hospital can use its
beds to provide either acute- or SNFlevel care, as needed. For critical access
hospitals (CAHs), Part A pays on a
reasonable cost basis for SNF-level
services furnished under a swing-bed
agreement. However, in accordance
with section 1888(e)(7) of the Act, SNFlevel services furnished by non-CAH
rural hospitals are paid under the SNF
PPS, effective with cost reporting
periods beginning on or after July 1,
2002. As explained in the FY 2002 final
rule (66 FR 39562), this effective date is
consistent with the statutory provision
to integrate swing-bed rural hospitals
into the SNF PPS by the end of the
transition period, June 30, 2002.
Accordingly, all non-CAH swing-bed
rural hospitals have now come under
the SNF PPS. Therefore, all rates and
wage indexes outlined in earlier
sections of this final rule for the SNF
PPS also apply to all non-CAH swingbed rural hospitals. As finalized in the
FY 2010 SNF PPS final rule (74 FR
40356 through 40357), effective October
1, 2010, non-CAH swing-bed rural
hospitals are required to complete an
MDS 3.0 swing-bed assessment which is
limited to the required demographic,
payment, and quality items. As
discussed in the FY 2019 SNF PPS final
rule (83 FR 39235), revisions were made
to the swing bed assessment in order to
support implementation of PDPM,
effective October 1, 2019. A discussion
of the assessment schedule and the MDS
effective beginning FY 2020 appears in
the FY 2019 SNF PPS final rule (83 FR
39229 through 39237). The latest
changes in the MDS for swing-bed rural
hospitals appear on the SNF PPS
website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/.
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17633
V. Issues Relating to PDPM
Implementation
A. Revised Group Therapy Definition
As set forth in the FY 2019 SNF PPS
final rule (83 FR 39162), effective
October 1, 2019 under the PDPM,
patients will be classified into case-mix
groups under each therapy component
based on patient characteristics rather
than using the volume of therapy
services furnished to the patient as the
basis for classification. Additionally, as
discussed in the FY 2019 SNF PPS final
rule (83 FR 39237 through 39243), we
finalized a combined limit on
concurrent and group therapy furnished
to a patient, specifically that, for each
therapy discipline, no more than 25
percent of the therapy services
furnished to a patient in a covered
Medicare Part A stay may be in a group
or concurrent setting. Given these policy
changes relating to therapy
classification and therapy provision
under the PDPM, as well as recent
efforts to increase standardization across
PAC settings, we believed it was
appropriate to evaluate other policies
associated with therapy under PDPM to
determine if other policies should be
revised as well.
In the FY 2012 SNF PPS final rule (76
FR 48511 through 48517), we finalized
changes relating to the definition of
group therapy and payment of group
therapy services, specifically to define
group therapy as the practice of one
therapist or therapy assistant treating
four patients at the same time while the
patients are performing either the same
or similar activities. In the FY 2012 SNF
PPS final rule (76 FR 48511), we noted
that, using our STRIVE data as a
baseline, we identified under RUG–IV
two significant changes in provider
behavior related to the provision of
therapy services to Medicare
beneficiaries in SNFs. First, we saw a
major decrease in the amount of
concurrent therapy (that is therapy
provided to two patients by one
therapist or therapy assistant doing
different activities) performed in SNFs,
the minutes for which are divided
between the two concurrent therapy
participants when determining the
patient’s appropriate RUG classification.
At the same time, we found a significant
increase in the amount of group therapy
services, which were not subject to the
allocation requirement. Given this
increase in group therapy services, we
expressed concern that the method for
reporting group therapy on the MDS
created an inappropriate payment
incentive to perform the group therapy
in place of individual therapy, because
the method of reporting group therapy
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time did not require allocation among
patients.
As we stated in the FY 2012 SNF PPS
final rule (76 FR 48511), because in
group therapy, patients are performing
similar activities, in contrast to
concurrent therapy, group therapy gives
patients the opportunity to benefit from
each other’s therapy regimen by
observing and interacting with one
another and applying the lessons
learned from others to one’s own
therapy program in order to progress. At
that time, we stated that large groups,
such as those of five or more
participants, can make it difficult for the
participants to engage with one another
over the course of the session. In
addition, we have long believed that
individual therapists could not
adequately supervise large groups, and
since the inception of the SNF PPS in
July 1998, we have capped the number
of residents at four. Furthermore, we
believed that groups of fewer than four
participants did not maximize the group
therapy benefit for the participants. As
we stated in the FY 2012 final rule (76
FR 48511), we believed that in groups
of two or three participants, the
opportunities for patients in the group
to interact and learn from each other are
significantly diminished given the small
size of the group. Thus, we revised the
definition of group therapy to require a
group size for the SNF setting of exactly
four patients, which we believed was
the size that permits the therapy
participants to derive the maximum
benefit from the group therapy setting.
Since that time, we have monitored
group therapy utilization and found
that, as discussed in the FY 2019 SNF
PPS final rule (83 FR 39237 through
39238), group therapy represents a very
small proportion of therapy provided to
SNF patients. Further, as discussed in
the FY 2019 SNF PPS final rule (83 FR
39240 through 39241), some
commenters suggested that we revise
the definition of group therapy to
include two to six participants doing the
same or similar activities, as this would
better align with the Inpatient
Rehabilitation Facility (IRF) setting and
allow increased flexibility so that
patients in smaller SNFs, presumably
where a group of exactly four patients
may be difficult to attain, could utilize
and benefit from group therapy. In our
response to these comments, in the FY
2019 SNF PPS final rule (83 FR 39241),
we stated that we may consider
changing the definition of group therapy
in future rulemaking. In the past we
stated our concern that a group that
consisted of more than 4 participants
would not allow for adequate
supervision of each participant as well
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as cause difficulty for participants to
engage with one another in the most
effective way. Conversely, we
maintained that a group of fewer than 4
participants would not allow for
effective interaction to best achieve the
goals of a group. For these reasons, we
defined group therapy as exactly 4
participants. However, based on our
review of the use of group therapy in the
IRF and outpatient settings where the
definition of group therapy is less
restrictive than the current definition
under the SNF PPS, we have found that
therapists do seem capable of managing
groups of various sizes. Based on this
review, we believe therapists have the
clinical judgment to determine whether
groups of different sizes would
clinically benefit their patients, which
they should be able to demonstrate with
adequate documentation. Patients can
often benefit from the psycho-social
aspect of groups, and in some situations,
a group of six participants is not too
large to provide that benefit to
participants. For example, a cooking
activity which will provide very
functional therapy for patients planning
to return home can be done in a group
of six that will enhance the patient’s
psycho-social experience in the SNF.
Alternatively, a group of 2–3 patients
can be clinically useful for certain
patients as well. For example, a group
of 2–3 patients who have pragmatic
language difficulties following a stroke
or head injury could very well benefit
from a small communication group to
work on the social aspects of language
together without the concern of
distraction that a larger group might
cause. Thus, while we continue to
maintain minimal concerns that some
groups may be either too small or too
large to allow for effective interaction,
we believe that the potential clinical
benefits of various size groups outweigh
our concerns, and that it would be
appropriate to allow therapists greater
flexibility to perform therapy in groups
of different sizes.
In light of our discussion above and
the comments in the FY 2019 SNF PPS
final rule, and to align the SNF PPS
more closely with other settings, in this
proposed rule, we propose to adopt a
new definition of group therapy for use
under PDPM, effective October 1, 2019,
as further discussed below.
In an effort to support CMS’ crosssetting initiatives under the IMPACT
Act and Meaningful Measures Initiative,
we have looked at ways to align the
definition of group therapy used under
the SNF PPS more closely with the
definitions used within the outpatient
setting covered under Medicare Part B
and under the IRF PPS, as this type of
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standardization would reduce
administrative burden on providers by
utilizing the same or similar definitions
across settings. For group therapy in the
outpatient setting, the Medicare Benefit
Policy Manual, Chapter 15, Section 230
states that contractors pay for outpatient
physical therapy services (which
includes outpatient speech-language
pathology services) and outpatient
occupational therapy services provided
simultaneously to two or more
individuals by a practitioner as group
therapy services (CPT code 97150). This
manual section further states that the
individuals can be, but need not be,
performing the same activity. In
addition, this section states that the
physician or therapist involved in group
therapy services must be in constant
attendance, but one-on-one patient
contact is not required. Under the IRF
PPS, the definition of group therapy
(found in Section 2 of the IRF PAI
Training Manual, https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/
Downloads/IRFPAI-1_5-2_0.zip) is the
provision of therapy services by one
licensed or certified therapist (or
licensed therapy assistant, under the
appropriate direction of a licensed or
certified therapist) treating two to six
patients at the same time who are
performing the same or similar
activities.
We considered using the same
definition as used in the outpatient
setting covered under Medicare Part B,
which is two or more patients
performing either the same or different
activity, as opposed to the IRF
definition of two to six patients
performing the same or similar
activities. However, given the greater
degree of similarity between the IRF and
SNF settings in terms of the intensity of
therapy and patient acuity, we believe
that the IRF PPS definition would be
more appropriate in the SNF setting.
Accordingly, for the reasons
discussed previously, we are proposing
to define group therapy in the SNF Part
A setting as a qualified rehabilitation
therapist or therapy assistant treating
two to six patients at the same time who
are performing the same or similar
activities. We believe this definition
would offer therapists more clinical
flexibility when determining the
appropriate number for a group, without
compromising the therapist’s ability to
manage the group and the patient’s
ability to interact effectively and benefit
from group therapy.
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We continue to believe that
individual therapy is the preferred
mode of therapy provision and offers
the most tailored service for patients. As
we stated in the FY 2012 proposed rule
(76 FR 26387), while group therapy can
play an important role in SNF patient
care, group therapy is not appropriate
for either all patients or for all
conditions, and is primarily effective as
a supplement to individual therapy,
which we maintain should be
considered the primary therapy mode
and standard of care in therapy services
provided to SNF residents.
Additionally, we continue to maintain
that when group therapy is used in a
SNF, therapists must document its use
in order to demonstrate why it is the
most appropriate mode of therapy for
the patient who is receiving it. As stated
in the FY 2012 proposed rule (76 FR
26388) regarding group therapy
documentation, because group therapy
is not appropriate for either all patients
or all conditions, and in order to verify
that group therapy is medically
necessary and appropriate to the needs
of each beneficiary, SNFs should
include in the patient’s plan of care an
explicit justification for the use of
group, rather than individual or
concurrent, therapy. This description
should include, but need not be limited
to, the specific benefits to that particular
patient of including the documented
type and amount of group therapy; that
is, how the prescribed type and amount
of group therapy will meet the patient’s
needs and assist the patient in reaching
the documented goals. In addition, we
believe that the above documentation is
necessary to demonstrate that the SNF
is providing services to attain or
maintain the highest practicable
physical, mental, and psychosocial
well-being of each resident in
accordance with section 1819(b)(2) of
the Act.
B. Updating ICD–10 Code Mappings and
Lists
In the FY 2019 SNF PPS final rule (83
FR 39162), we finalized the
implementation of PDPM, effective
October 1, 2019. The PDPM utilizes
ICD–10 codes in several ways, including
to assign patients to clinical categories
used for categorization in the PT, OT,
and SLP components, as well as
identifying certain comorbidities
relevant for classification under the SLP
and NTA components. The ICD–10
mappings and lists that would be used
under PDPM, once implemented, are
available on the PDPM website at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
SNFPPS/PDPM.html.
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Each year, the ICD–10 Coordination
and Maintenance Committee, a federal
interdepartmental committee that is
chaired by representatives from the
National Center for Health Statistics
(NCHS) and by representatives from
CMS, meets biannually and publishes
updates to the ICD–10 medical code
data sets in June of each year. These
changes become effective October 1 of
the year in which these updates are
issued by the committee. The ICD–10
Coordination and Maintenance
Committee also has the ability to make
changes to the ICD–10 medical code
data sets effective on April 1, but has
not yet done so.
As providers are required to follow
the most up to date coding guidance
issued by this committee in accordance
with 45 CFR part 162, subpart J, it is
essential that we be able to update our
code mappings and lists consistent with
the latest coding guidance. Therefore, to
ensure that the ICD–10 mappings and
lists used under PDPM reflect the most
up to date codes possible, we propose
to update any ICD–10 code mappings
and lists used under PDPM, as well as
the SNF GROUPER software and other
such products related to patient
classification and billing, through a
subregulatory process which would
consist of posting updated code
mappings and lists on the PDPM
website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/PDPM.html. More
specifically, beginning with the updates
for FY 2020 (see discussion below),
nonsubstantive changes to the ICD–10
codes included on the code mappings
and lists under the PDPM would be
applied through the subregulatory
process described above, and
substantive revisions to the ICD–10
codes on the code mappings and lists
used under the PDPM would be
proposed and finalized through notice
and comment rulemaking.
Nonsubstantive changes would be
limited to those specific changes that
are necessary to maintain consistency
with the most current ICD–10 medical
code data set, which Medicare providers
are generally required to use. Our intent
in applying these nonsubstantive
changes through the proposed
subregulatory process would be to keep
the same conditions in the PDPM
clinical categories and comorbidities
lists, but ensure that the codes used to
identify those conditions are
synchronized with the most current
ICD–10 medical code data set. For
example, to the extent that the ICD–10–
CM Coordination and Maintenance
Committee changes an ICD–10 code for
a comorbid condition on our
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comorbidities lists into one or more
codes that provide additional detail, we
would update the SNF GROUPER
software and ICD–10 mappings and lists
on the CMS website to reflect the new
codes through the subregulatory process
proposed above. By contrast, we would
use notice and comment rulemaking to
make substantive changes to the ICD–10
code mappings and lists under the
PDPM. For the purposes of this policy,
a substantive change would be defined
simply as any change that does not fall
within the definition of a
nonsubstantive change—that is, changes
that go beyond the intention of
maintaining consistency with the most
current ICD–10 medical code data set.
For instance, changes to the assignment
of a code to a comorbidity list or other
changes that amount to changes in
policy would be substantive changes.
Taking the example above, there may be
situations in which the addition of one
or more of these new codes to the list
of comorbidities may not be
appropriate. For example, the ICD–10
code for a particular condition is
divided into two more detailed codes,
one of which represents a condition that
generally is predictive of the costs of
care in a SNF and one of which is not.
We would propose through notice and
comment rulemaking to delete the code
that does not reflect increased costs of
care in a SNF from the list of
comorbidities in the SNF GROUPER
software because removing the code
would constitute a substantive change.
We propose to indicate all changes to
codes in the GROUPER software by
posting a complete ICD–10 mapping
table, including new, discontinued, and
modified codes, on the PDPM website at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
SNFPPS/PDPM.html. We also propose
to report the complete list of ICD–10
codes associated with the SNF PDPM
clinical categories and SLP/NTA
comorbidities in the SNF GROUPER
documentation, which is also posted on
the PDPM website. All changes would
be included in these documents, with
substantive changes being included only
after being finalized through notice and
comment rulemaking.
We believe that the proposed
subregulatory update process (by which
nonsubstantive changes to the ICD–10
code mappings and lists used under
PDPM as well as the SNF GROUPER
software and other such products
related to patient classification and
billing would be posted on the CMS
websites specified above), is the best
way for us to convey information about
changes to the ICD–10 medical code
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data set that affect the code mappings
and lists used under the PDPM. We
believe the proposed subregulatory
process would help ensure providers
have the most up-to-date information as
soon as possible, in the clearest and
most useful format, as opposed to
publishing each nonsubstantive change
to the ICD–10 codes in a rule after
notice and comment rulemaking.
Additionally, the proposed
subregulatory process is in alignment
with similar policies in the SNF PPS
and the IRF PPS settings. For example,
the SNF PPS already uses a
subregulatory process to make
nonsubstantive updates to the list of
Healthcare Common Procedure Coding
System (HCPCS) codes that are subject
to the consolidated billing (CB)
provision of the SNF PPS. We post
routine annual updates to the lists of
codes that are included or excluded
from CB on the SNF CB website at
https://www.cms.gov/Medicare/Billing/
SNFConsolidatedBilling/.
The new codes identified in each
update describe the same services that
are subject to SNF PPS CB. No
additional services are added by these
routine updates; that is, these updates
are necessary because of changes to the
coding system, not because the services
subject to SNF CB are being redefined.
We believe the proposed subregulatory
process to update ICD–10 codes
associated with PDPM clinical
categories and comorbidity lists is
appropriate given that it is consistent
with this subregulatory process already
in use under the SNF PPS to make
nonsubstantive coding updates.
Likewise, the IRF PPS also utilizes
processes similar to that proposed here.
In the FY 2007 IRF PPS final rule (71
FR 48360 through 48361), we
implemented a similar subregulatory
updating process for the IRF tier
comorbidities list, and the FY 2018 IRF
PPS final rule (82 FR 36267 through
36269) established a similar process for
updating the ICD–10 code lists used for
the IRF presumptive compliance
methodology. Both the IRF tier
comorbidities list and the IRF
presumptive compliance methodology
also use ICD–10 codes. Therefore, we
believe the subregulatory process
proposed in this rule is appropriate
because it is also consistent with
processes used in another Medicare
setting.
We are proposing that this
subregulatory process for updating the
ICD–10 codes used under the PDPM
would take effect beginning with the
updates for FY 2020. The proposed
ICD–10 code mappings and lists for use
under the PDPM are available for
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download from the SNF PPS website
(https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
SNFPPS/PDPM.html). These mappings
and lists reflect the adoption of the ICD–
10 Coordination and Maintenance
Committee’s draft changes to the ICD–10
medical code data sets, effective October
1, 2018. The version of these mappings
and lists that is finalized in conjunction
with the FY 2020 SNF PPS final rule
would constitute the baseline for any
future updates to the mappings and lists
using the proposed process above.
C. Revisions to the Regulation Text
Along with our proposed revisions as
discussed elsewhere in this proposed
rule, we are also proposing to make
certain revisions to the regulations text
itself to reflect the revised assessment
schedule under the PDPM, as finalized
in the FY 2019 SNF PPS final rule (83
FR 39229). Specifically, we propose to
revise the prescribed PPS assessment
schedule as set forth in § 413.343(b), to
reflect the elimination, upon the
conversion from RUG–IV to PDPM on
October 1, 2019, of all scheduled
assessments after the initial 5-day,
Medicare-required assessment. We note
that even though this assessment is
commonly referred to as the ‘‘5-day’’
assessment (reflecting its original 5-day
assessment window), an additional 3
grace days have always been available
beyond that window for its actual
completion. Further, because those
additional 3 grace days will be directly
incorporated into the assessment
window itself effective October 1, 2019
(as finalized in the FY 2019 SNF PPS
final rule (83 FR 39231, 39232, and
39234)), thus resulting in an overall 8day assessment window, we
additionally propose to include a
conforming revision in § 413.343(b) to
make clear that the actual deadline for
completing this assessment is no later
than the 8th day of posthospital SNF
care. In addition, because under the
PDPM, there is only one scheduled
patient assessment, we also propose to
replace the phrase ‘‘patient
assessments’’ in § 413.343(b) with the
phrase ‘‘an initial patient assessment.’’
Accordingly, we propose to revise
§ 413.343(b) to state that the assessment
schedule must include performance of
an initial patient assessment no later
than the 8th day of posthospital SNF
care.
We further propose to revise the
existing language in § 413.343(b) that
additionally requires the completion of
‘‘such other assessments that are
necessary to account for changes in
patient care needs,’’ to state ‘‘such other
interim payment assessments as the
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SNF determines are necessary to
account for changes in patient care
needs.’’ As we finalized in the FY 2019
SNF PPS final rule (83 FR 39230
through 39234), the optional Interim
Payment Assessment (IPA) will serve as
the instrument for conducting
assessments under the PDPM that the
SNF determines are necessary after the
completion of the 5-day, Medicarerequired assessment to address clinical
changes throughout a SNF stay. We
believe that our proposed language is
consistent with the expectation
expressed in the FY 2019 SNF PPS final
rule for SNFs ‘‘. . . to provide excellent
skilled nursing and rehabilitative care
and continually monitor and document
patient status’’ (83 FR 39233), and
makes clear that the SNF’s
responsibility in this context would
include recognizing those situations that
warrant a decision to complete an IPA
in order to account appropriately for a
change in patient status. Finally, to
ensure consistency, we also propose to
make a conforming revision to the
regulations text in the introductory
paragraph of § 409.30, so that it would
use the same terminology of ‘‘initial
patient assessment’’ as would appear in
revised § 413.343(b). Specifically, in the
introductory paragraph of § 409.30, we
would replace the phrase ‘‘the 5-day
assessment’’ with ‘‘the initial patient
assessment.’’ We note that the
regulations text in the introductory
paragraph of § 409.30 would continue to
specify that the assessment reference
date (ARD) for this assessment must
occur no later than the 8th day of
posthospital SNF care, consistent with
the instructions set forth in sections 2.8
and 2.9 of the RAI Version 3.0 Manual.
VI. Other Issues
A. Skilled Nursing Facility (SNF)
Quality Reporting Program (QRP)
1. Background
The Skilled Nursing Facility Quality
Reporting Program (SNF QRP) is
authorized by section 1888(e)(6) of the
Act and it applies to freestanding SNFs,
SNFs affiliated with acute care facilities,
and all non-CAH swing-bed rural
hospitals. Under the SNF QRP, the
Secretary must reduce by 2 percentage
points the annual market basket
percentage update described in section
1888(e)(5)(B)(i) of the Act applicable to
a SNF for a fiscal year, after application
of section 1888(e)(5)(B)(ii) of the Act
(the MFP adjustment) and section
1888(e)(5)(B)(iii) of the Act, in the case
of a SNF that does not submit data in
accordance with sections
1888(e)(6)(B)(i) of the Act for that fiscal
year. For more information on the
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requirements we have adopted for the
SNF QRP, we refer readers to the FY
2016 SNF PPS final rule (80 FR 46427
through 46429), FY 2017 SNF PPS final
rule (81 FR 52009 through 52010), FY
2018 SNF PPS final rule (82 FR 36566),
and FY 2019 SNF PPS final rule (83 FR
39162 through 39272).
17637
2. General Considerations Used for the
Selection of Measures for the SNF QRP
refer readers to the FY 2016 SNF PPS
final rule (80 FR 46429 through 46431).
For a detailed discussion of the
considerations we historically used for
the selection of SNF QRP quality,
resource use, and other measures, we
3. Quality Measures Currently Adopted
for the FY 2021 SNF QRP
The SNF QRP currently has 11
measures for the FY 2021 SNF QRP,
which are set out in Table 12.
TABLE 12—QUALITY MEASURES CURRENTLY ADOPTED FOR THE FY 2021 SNF QRP
Short name
Measure name & data source
Resident Assessment Instrument Minimum Data Set
Pressure Ulcer/Injury ......................
Application of Falls ..........................
Application of Functional Assessment/Care Plan.
Change in Mobility Score ................
Discharge Mobility Score ................
Change in Self-Care Score .............
Discharge Self-Care Score .............
DRR ................................................
Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/Injury.
Application of Percent of Residents Experiencing One or More Falls with Major Injury (Long Stay) (NQF
#0674).
Application of Percent of Long-Term Care Hospital (LTCH) Patients with an Admission and Discharge
Functional Assessment and a Care Plan That Addresses Function (NQF #2631).
Application of IRF Functional Outcome Measure: Change in Mobility Score for Medical Rehabilitation Patients (NQF #2634).
Application of IRF Functional Outcome Measure: Discharge Mobility Score for Medical Rehabilitation Patients (NQF #2636).
Application of the IRF Functional Outcome Measure: Change in Self-Care Score for Medical Rehabilitation
Patients (NQF #2633).
Application of IRF Functional Outcome Measure: Discharge Self-Care Score for Medical Rehabilitation Patients (NQF #2635).
Drug Regimen Review Conducted With Follow-Up for Identified Issues–Post Acute Care (PAC) Skilled
Nursing Facility (SNF) Quality Reporting Program (QRP).
Claims-Based
MSPB SNF ......................................
DTC .................................................
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PPR .................................................
Medicare Spending Per Beneficiary (MSPB)–Post Acute Care (PAC) Skilled Nursing Facility (SNF) Quality
Reporting Program (QRP).
Discharge to Community (DTC)–Post Acute Care (PAC) Skilled Nursing Facility (SNF) Quality Reporting
Program (QRP).
Potentially Preventable 30-Day Post-Discharge Readmission Measure for Skilled Nursing Facility (SNF)
Quality Reporting Program (QRP).
4. SNF QRP Quality Measure Proposals
Beginning With the FY 2022 SNF QRP
In this proposed rule, we are
proposing to adopt two process
measures for the SNF QRP that, as
required by section 1888(e)(6)(B)(i)(II) of
the Act, would satisfy section
1899B(c)(1)(E)(ii) of the Act, which
requires that the quality measures
specified by the Secretary include
measures with respect to the quality
measure domain titled ‘‘Accurately
communicating the existence of and
providing for the transfer of health
information and care preferences of an
individual to the individual, family
caregiver of the individual, and
providers of services furnishing items
and services to the individual when the
individual transitions from a post-acute
care (PAC) provider to another
applicable setting, including a different
PAC provider, a hospital, a critical
access hospital, or the home of the
individual.’’ Given the length of this
domain title, hereafter, we will refer to
this quality measure domain as
‘‘Transfer of Health Information.’’
The two measures we are proposing to
adopt are: (1) Transfer of Health
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Information to the Provider–Post-Acute
Care (PAC); and (2) Transfer of Health
Information to the Patient–Post-Acute
Care (PAC). Both of these proposed
measures support our Meaningful
Measures priority of promoting effective
communication and coordination of
care, specifically the Meaningful
Measure area of the transfer of health
information and interoperability.
In addition to the two measure
proposals, we are proposing to update
the specifications for the Discharge to
Community—PAC SNF QRP measure to
exclude baseline nursing facility (NF)
residents from the measure.
We are seeking public comment on
each of these proposals.
a. Proposed Transfer of Health
Information to the Provider–Post-Acute
Care (PAC) Measure
The proposed Transfer of Health
Information to the Provider–Post-Acute
Care (PAC) Measure is a process-based
measure that assesses whether or not a
current reconciled medication list is
given to the subsequent provider when
a patient is discharged or transferred
from his or her current PAC setting.
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(1) Background
In 2013, 22.3 percent of all acute
hospital discharges were discharged to
PAC settings, including 11 percent who
were discharged to home under the care
of a home health agency, and nine
percent who were discharged to SNFs.1
The proportion of patients being
discharged from an acute care hospital
to a PAC setting was greater among
beneficiaries enrolled in Medicare feefor-service (FFS). Among Medicare FFS
patients discharged from an acute
hospital, 42 percent went directly to
PAC settings. Of that 42 percent, 20
percent were discharged to a SNF, 18
percent were discharged to a home
health agency (HHA), 3 percent were
discharged to an IRF, and 1 percent
were discharged to an LTCH.2 Of the
Medicare FFS beneficiaries with a SNF
stay in FY 2017, an estimated 21 percent
were discharged or transferred to an
acute care hospital, 11 percent
discharged home with home health
1 Tian, W. ‘‘An all-payer view of hospital
discharge to post-acute care,’’ May 2016. Available
at https://www.hcup-us.ahrq.gov/reports/statbriefs/
sb205-Hospital-Discharge-Postacute-Care.jsp.
2 Ibid.
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services, and two percent discharged or
transferred to another PAC setting (for
example, an IRF, a hospice, or another
SNF).3
The transfer and/or exchange of
health information from one provider to
another can be done verbally (for
example, clinician-to-clinician
communication in-person or by
telephone), paper-based (for example,
faxed or printed copies of records), and
via electronic communication (for
example, through a health information
exchange network using an electronic
health/medical record, and/or secure
messaging). Health information, such as
medication information, that is
incomplete or missing increases the
likelihood of a patient or resident safety
risk, and is often life-threatening.4 5 6 7 8 9
Poor communication and coordination
across health care settings contributes to
patient complications, hospital
readmissions, emergency department
visits, and medication
errors.10 11 12 13 14 15 16 17 18 19
3 RTI International analysis of Medicare claims
data for index stays in SNF 2017. (RTI program
reference: IB55).
4 Kwan, J.L., Lo, L., Sampson, M., & Shojania,
K.G., ‘‘Medication reconciliation during transitions
of care as a patient safety strategy: a systematic
review,’’ Annals of Internal Medicine, 2013, Vol.
158(5), pp. 397–403.
5 Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ‘‘Effect
of admission medication reconciliation on adverse
drug events from admission medication changes,’’
Archives of Internal Medicine, 2011, Vol. 171(9),
pp. 860–861.
6 Bell, C.M., Brener, S.S., Gunraj, N., Huo, C.,
Bierman, A.S., Scales, D.C., & Urbach, D.R.,
‘‘Association of ICU or hospital admission with
unintentional discontinuation of medications for
chronic diseases,’’ JAMA, 2011, Vol. 306(8), pp.
840–847.
7 Basey, A.J., Krska, J., Kennedy, T.D., &
Mackridge, A.J., ‘‘Prescribing errors on admission to
hospital and their potential impact: a mixedmethods study,’’ BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17–25.
8 Desai, R., Williams, C.E., Greene, S.B., Pierson,
S., & Hansen, R.A., ‘‘Medication errors during
patient transitions into nursing homes:
characteristics and association with patient harm,’’
The American Journal of Geriatric
Pharmacotherapy, 2011, Vol. 9(6), pp. 413–422.
9 Boling, P.A., ‘‘Care transitions and home health
care,’’ Clinical Geriatric Medicine, 2009, Vol. 25(1),
pp. 135–48.
10 Barnsteiner, J.H., ‘‘Medication Reconciliation:
Transfer of medication information across
settings—keeping it free from error,’’ The American
Journal of Nursing, 2005, Vol. 105(3), pp. 31–36.
11 Arbaje, A.I., Kansagara, D.L., Salanitro, A.H.,
Englander, H.L., Kripalani, S., Jencks, S.F., &
Lindquist, L.A., ‘‘Regardless of age: incorporating
principles from geriatric medicine to improve care
transitions for patients with complex needs,’’
Journal of General Internal Medicine, 2014, Vol.
29(6), pp. 932–939.
12 Jencks, S.F., Williams, M.V., & Coleman, E.A.,
‘‘Rehospitalizations among patients in the Medicare
fee-for-service program,’’ New England Journal of
Medicine, 2009, Vol. 360(14), pp. 1418–1428.
13 Institute of Medicine. ‘‘Preventing medication
errors: quality chasm series,’’ Washington, DC: The
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Communication has been cited as the
third most frequent root cause in
sentinel events, which The Joint
Commission 20 defines as a patient
safety event that results in death,
permanent harm, or severe temporary
harm. Failed or ineffective patient
handoffs are estimated to play a role in
20 percent of serious preventable
adverse events.21 When care transitions
are enhanced through care coordination
activities, such as expedited patient
information flow, these activities can
reduce duplication of care services and
costs of care, resolve conflicting care
plans, and prevent medical
errors.22 23 24 25 26
National Academies Press 2007. Available at
https://www.nap.edu/read/11623/chapter/1.
14 Kitson, N.A., Price, M., Lau, F.Y., & Showler,
G., ‘‘Developing a medication communication
framework across continuums of care using the
Circle of Care Modeling approach,’’ BMC Health
Services Research, 2013, Vol. 13(1), pp. 1–10.
15 Mor, V., Intrator, O., Feng, Z., & Grabowski,
D.C., ‘‘The revolving door of rehospitalization from
skilled nursing facilities,’’ Health Affairs, 2010, Vol.
29(1), pp. 57–64.
16 Institute of Medicine. ‘‘Preventing medication
errors: quality chasm series,’’ Washington, DC: The
National Academies Press 2007. Available at
https://www.nap.edu/read/11623/chapter/1.
17 Kitson, N.A., Price, M., Lau, F.Y., & Showler,
G., ‘‘Developing a medication communication
framework across continuums of care using the
Circle of Care Modeling approach,’’ BMC Health
Services Research, 2013, Vol. 13(1), pp. 1–10.
18 Forster, A.J., Murff, H.J., Peterson, J.F., Gandhi,
T.K., & Bates, D.W., ‘‘The incidence and severity of
adverse events affecting patients after discharge
from the hospital.’’ Annals of Internal Medicine,
2003,138(3), pp. 161–167.
19 King, B.J., Gilmore-Bykovskyi, A.L., Roiland,
R.A., Polnaszek, B.E., Bowers, B.J., & Kind, A.J.
‘‘The consequences of poor communication during
transitions from hospital to skilled nursing facility:
a qualitative study,’’ Journal of the American
Geriatrics Society, 2013, Vol. 61(7), 1095–1102.
20 The Joint Commission, ‘‘Sentinel Event Policy’’
available at https://www.jointcommission.org/
sentinel_event_policy_and_procedures/.
21 The Joint Commission. ‘‘Sentinel Event Data
Root Causes by Event Type 2004–2015.’’ 2016.
Available at https://www.jointcommission.org/
assets/1/23/jconline_Mar_2_2016.pdf.
22 Mor, V., Intrator, O., Feng, Z., & Grabowski,
D.C., ‘‘The revolving door of rehospitalization from
skilled nursing facilities,’’ Health Affairs, 2010, Vol.
29(1), pp. 57–64.
23 Institute of Medicine, ‘‘Preventing medication
errors: quality chasm series,’’ Washington, DC: The
National Academies Press, 2007. Available at
https://www.nap.edu/read/11623/chapter/1.
24 Starmer, A.J., Sectish, T.C., Simon, D.W.,
Keohane, C., McSweeney, M.E., Chung, E.Y., Yoon,
C.S., Lipsitz, S.R., Wassner, A.J., Harper, M.B., &
Landrigan, C.P., ‘‘Rates of medical errors and
preventable adverse events among hospitalized
children following implementation of a resident
handoff bundle,’’ JAMA, 2013, Vol. 310(21), pp.
2262–2270.
25 Pronovost, P., M.M.E. Johns, S. Palmer, R.C.
Bono, D.B. Fridsma, A. Gettinger, J. Goldman, W.
Johnson, M. Karney, C. Samitt, R.D. Sriram, A.
Zenooz, and Y.C. Wang, Editors. Procuring
Interoperability: Achieving High-Quality,
Connected, and Person-Centered Care. Washington,
DC, 2018. National Academy of Medicine. Available
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Care transitions across health care
settings have been characterized as
complex, costly, and potentially
hazardous, and may increase the risk for
multiple adverse outcomes.27 28 The
rising incidence of preventable adverse
events, complications, and hospital
readmissions have drawn attention to
the importance of the timely transfer of
health information and care preferences
at the time of transition. Failures of care
coordination, including poor
communication of information, were
estimated to cost the U.S. health care
system between $25 billion and $45
billion in wasteful spending in 2011.29
The communication of health
information and patient care preferences
is critical to ensuring safe and effective
transitions from one health care setting
to another.30 31
Patients in PAC settings often have
complicated medication regimens and
require efficient and effective
communication and coordination of
care between settings, including
detailed transfer of medication
information.32 33 34 Individuals in PAC
at https://nam.edu/wp-content/uploads/2018/10/
Procuring-Interoperability_web.pdf.
26 Balaban RB, Weissman JS, Samuel PA, &
Woolhandler, S., ‘‘Redefining and redesigning
hospital discharge to enhance patient care: a
randomized controlled study,’’ J Gen Intern Med,
2008, Vol. 23(8), pp. 1228–33.
27 Arbaje, A.I., Kansagara, D.L., Salanitro, A.H.,
Englander, H.L., Kripalani, S., Jencks, S.F., &
Lindquist, L.A., ‘‘Regardless of age: incorporating
principles from geriatric medicine to improve care
transitions for patients with complex needs,’’
Journal of General Internal Medicine, 2014, Vol
29(6), pp. 932–939.
28 Simmons, S., Schnelle, J., Slagle, J., Sathe,
N.A., Stevenson, D., Carlo, M., & McPheeters, M.L.,
‘‘Resident safety practices in nursing home
settings.’’ Technical Brief No. 24 (Prepared by the
Vanderbilt Evidence-based Practice Center under
Contract No. 290–2015–00003–I.) AHRQ
Publication No. 16–EHC022–EF. Rockville, MD:
Agency for Healthcare Research and Quality. May
2016. Available at https://www.ncbi.nlm.nih.gov/
books/NBK384624/.
29 Berwick, D.M. & Hackbarth, A.D. ‘‘Eliminating
Waste in US Health Care,’’ JAMA, 2012, Vol.
307(14), pp.1513–1516.
30 McDonald, K.M., Sundaram, V., Bravata, D.M.,
Lewis, R., Lin, N., Kraft, S.A. & Owens, D.K. Care
Coordination. Vol. 7 of: Shojania K.G., McDonald
K.M., Wachter R.M., Owens D.K., editors. ‘‘Closing
the quality gap: A critical analysis of quality
improvement strategies.’’ Technical Review 9
(Prepared by the Stanford University-UCSF
Evidence-based Practice Center under contract 290–
02–0017). AHRQ Publication No. 04(07)–0051–7.
Rockville, MD: Agency for Healthcare Research and
Quality. June 2006. Available at https://
www.ncbi.nlm.nih.gov/books/NBK44015/.
31 Lattimer, C., ‘‘When it comes to transitions in
patient care, effective communication can make all
the difference,’’ Generations, 2011, Vol. 35(1), pp.
69–72.
32 Starmer A.J., Spector N.D., Srivastava R., West,
D.C., Rosenbluth, G., Allen, A.D., Noble, E.L., &
Landrigen, C.P., ‘‘Changes in medical errors after
implementation of a handoff program,’’ N Engl J
Med, 2014, Vol. 37(1), pp. 1803–1812.
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settings may be vulnerable to adverse
health outcomes due to insufficient
medication information on the part of
their health care providers, and the
higher likelihood for multiple comorbid
chronic conditions, polypharmacy, and
complicated transitions between care
settings.35 36 Preventable adverse drug
events (ADEs) may occur after hospital
discharge in a variety of settings
including PAC.37 A 2014 Office of
Inspector General report found that
almost one-tenth of Medicare
beneficiaries experienced an ADE, such
as delirium, bleeding, fall or injury, or
constipation, during their stay in a SNF
in 2011. Of these, two-thirds were
classified as preventable.38 Medication
errors and one-fifth of ADEs occur
during transitions between settings,
including admission to or discharge
from a hospital to home or a PAC
setting, or transfer between
hospitals.39 40
Patients in PAC settings are often
taking multiple medications.
Consequently, PAC providers regularly
33 Kruse, C.S. Marquez, G., Nelson, D., &
Polomares, O., ‘‘The use of health information
exchange to augment patient handoff in long-term
care: a systematic review,’’ Applied Clinical
Informatics, 2018, Vol. 9(4), pp. 752–771.
34 Brody, A.A., Gibson, B., Tresner-Kirsch, D.,
Kramer, H., Thraen, I., Coarr, M.E., & Rupper, R.,
‘‘High prevalence of medication discrepancies
between home health referrals and Centers for
Medicare and Medicaid Services home health
certification and plan of care and their potential to
affect safety of vulnerable elderly adults,’’ Journal
of the American Geriatrics Society, 2016, Vol.
64(11), pp. e166 e170.
35 Chhabra, P.T., Rattinger, G.B., Dutcher, S.K.,
Hare, M.E., Parsons, K., L., & Zuckerman, I.H.,
‘‘Medication reconciliation during the transition to
and from long-term care settings: a systematic
review,’’ Res Social Adm Pharm, 2012, Vol. 8(1),
pp. 60–75.
36 Levinson, D.R., & General, I., ‘‘Adverse events
in skilled nursing facilities: national incidence
among Medicare beneficiaries.’’ Washington, DC:
U.S. Department of Health and Human Services,
Office of Inspector General, February 2014.
Available at https://oig.hhs.gov/oei/reports/oei-0611-00370.pdf.
37 Battles J., Azam I., Grady M., & Reback K.,
‘‘Advances in patient safety and medical liability,’’
AHRQ Publication No. 17–0017–EF. Rockville, MD:
Agency for Healthcare Research and Quality,
August 2017. Available at https://www.ahrq.gov/
sites/default/files/publications/files/advancescomplete_3.pdf.
38 Health and Human Services Office of Inspector
General. Adverse events in skilled nursing facilities:
National incidence among Medicare beneficiaries.
OEI–06–11–00370). 2014. Available at https://
oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
39 Barnsteiner, J.H., ‘‘Medication Reconciliation:
Transfer of medication information across
settings—keeping it free from error,’’ The American
Journal of Nursing, 2005, Vol. 105(3), pp. 31–36.
40 Gleason, K.M., Groszek, J.M., Sullivan, C.,
Rooney, D., Barnard, C., Noskin, G.A.,
‘‘Reconciliation of discrepancies in medication
histories and admission orders of newly
hospitalized patients,’’ American Journal of Health
System Pharmacy, 2004, Vol. 61(16), pp. 1689–
1694.
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are in the position of starting complex
new medication regimens with little
knowledge of the patients or their
medication history upon admission.
Furthermore, inter-facility
communication barriers delay resolving
medication discrepancies during
transitions of care.41 Medication
discrepancies are common,42 and found
to occur in 86 percent of all transitions,
increasing the likelihood of ADEs.43 44 45
Up to 90 percent of patients experience
at least one medication discrepancy in
the transition from hospital to home
care, and discrepancies occur within all
therapeutic classes of medications.46 47
Transfer of a medication list between
providers is necessary for medication
reconciliation interventions, which have
been shown to be a cost-effective way to
avoid ADEs by reducing errors,48 49 50
especially when medications are
41 Patterson M., Foust J.B., Bollinger, S., Coleman,
C., Nguyen, D., ‘‘Inter-facility communication
barriers delay resolving medication discrepancies
during transitions of care,’’ Research in Social &
Administrative Pharmacy (2018), doi: 10.1016/
j.sapharm.2018.05.124.
42 Manias, E., Annaikis, N., Considine, J.,
Weerasuriya, R., & Kusljic, S. ‘‘Patient-, medicationand environment-related factors affecting
medication discrepancies in older patients,’’
Collegian, 2017, Vol. 24, pp. 571–577.
43 Tjia, J., Bonner, A., Briesacher, B.A., McGee, S.,
Terrill, E., Miller, K., ‘‘Medication discrepancies
upon hospital to skilled nursing facility
transitions,’’ J Gen Intern Med, 2009, Vol. 24(5), pp.
630–635.
44 Sinvani, L.D., Beizer, J., Akerman, M.,
Pekmezaris, R., Nouryan, C., Lutsky, L., Cal, C.,
Dlugacz, Y., Masick, K., Wolf-Klein, G.,’’Medication
reconciliation in continuum of care transitions: a
moving target,’’ J Am Med Dir Assoc, 2013, Vol.
14(9), 668–672.
45 Coleman E.A., Parry C., Chalmers S., & Min,
S.J., ‘‘The Care Transitions Intervention: results of
a randomized controlled trial,’’ Arch Intern Med,
2006, Vol. 166, pp. 1822–1828.
46 Corbett C.L., Setter S.M., Neumiller J.J., &
Wood, l.D., ‘‘Nurse identified hospital to home
medication discrepancies: implications for
improving transitional care,’’ Geriatr Nurs, 2011,
Vol. 31(3), pp. 188–196.
47 Setter S.M., Corbett C.F., Neumiller J.J., Gates,
B.J., Sclar, D.A., & Sonnett, T.E., ‘‘Effectiveness of
a pharmacist-nurse intervention on resolving
medication discrepancies in older patients
transitioning from hospital to home care: impact of
a pharmacy/nursing intervention,’’ Am J Health
Syst Pharm, 2009, Vol. 66, pp. 2027–2031.
48 Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ‘‘Effect
of admission medication reconciliation on adverse
drug events from admission medication changes,’’
Archives of Internal Medicine, 2011, Vol. 171(9),
pp. 860–861.
49 Kwan, J.L., Lo, L., Sampson, M., & Shojania,
K.G., ‘‘Medication reconciliation during transitions
of care as a patient safety strategy: a systematic
review,’’ Annals of Internal Medicine, 2013, Vol.
158(5), pp. 397–403.
50 Chhabra, P.T., Rattinger, G.B., Dutcher, S.K.,
Hare, M.E., Parsons, K., L., & Zuckerman, I.H.,
‘‘Medication reconciliation during the transition to
and from long-term care settings: a systematic
review,’’ Res Social Adm Pharm, 2012, Vol. 8(1),
pp. 60–75.
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17639
reviewed by a pharmacist using
electronic medical records.51
(2) Stakeholder and Technical Expert
Panel (TEP) Input
The proposed measure was developed
after consideration of feedback we
received from stakeholders and four
TEPs convened by our contractors.
Further, the proposed measure was
developed after evaluation of data
collected during two pilot tests we
conducted in accordance with the CMS
Measures Management System
Blueprint.
Our measure development contractors
constituted a TEP which met on
September 27, 2016,52 January 27, 2017,
and August 3, 2017 53 to provide input
on a prior version of this measure.
Based on this input, we updated the
measure concept in late 2017 to include
the transfer of a specific component of
health information—medication
information. Our measure development
contractors reconvened this TEP on
April 20, 2018 for the purpose of
obtaining expert input on the proposed
measure, including the measure’s
reliability, components of face validity,
and feasibility of being implemented
across PAC settings. Overall, the TEP
was supportive of the proposed
measure, affirming that the measure
provides an opportunity to improve the
transfer of medication information. A
summary of the April 20, 2018 TEP
proceedings titled ‘‘Transfer of Health
Information TEP Meeting 4-June 2018’’
is available at https://www.cms.gov/
Medicare/Quality-Initiatives-Patient51 Agrawal A, Wu WY. ‘‘Reducing medication
errors and improving systems reliability using an
electronic medication reconciliation system,’’ The
Joint Commission Journal on Quality and Patient
Safety, 2009, Vol. 35(2), pp. 106–114.
52 Technical Expert Panel Summary Report:
Development of two quality measures to satisfy the
Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain
of Transfer of health Information and Care
Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient
Rehabilitation Facilities (IRFs), Long Term Care
Hospitals (LTCHs) and Home Health Agencies
(HHAs). Available at https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-Quality-Initiatives/
Downloads/Transfer-of-Health-Information-TEP_
Summary_Report_Final-June-2017.pdf.
53 Technical Expert Panel Summary Report:
Development of two quality measures to satisfy the
Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain
of Transfer of health Information and Care
Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient
Rehabilitation Facilities (IRFs), Long Term Care
Hospitals (LTCHs) and Home Health Agencies
(HHAs). Available at https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-Quality-Initiatives/
Downloads/Transfer-of-Health-Information-TEPMeetings-2-3-Summary-Report_Final_Feb2018.pdf.
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Assessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
Our measure development contractors
solicited stakeholder feedback on the
proposed measure by requesting
comment on the CMS Measures
Management System Blueprint website,
and accepted comments that were
submitted from March 19, 2018 to May
3, 2018. The comments received
expressed overall support for the
measure. Several commenters suggested
ways to improve the measure, primarily
related to what types of information
should be included at transfer. We
incorporated this input into
development of the proposed measure.
The summary report for the March 19 to
May 3, 2018 public comment period
titled ‘‘IMPACT Medication–ProfileTransferred–Public-CommentSummary-Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
(3) Pilot Testing
The proposed measure was tested
between June and August 2018 in a pilot
test that involved 24 PAC facilities/
agencies, including five IRFs, six SNFs,
six LTCHs, and seven HHAs. The 24
pilot sites submitted a total of 801
records. Analysis of agreement between
coders within each participating facility
(266 qualifying pairs) indicated a 93percent agreement for this measure.
Overall, pilot testing enabled us to
verify its reliability, components of face
validity, and feasibility of being
implemented across PAC settings.
Further, more than half of the sites that
participated in the pilot test stated
during the debriefing interviews that the
measure could distinguish facilities or
agencies with higher quality medication
information transfer from those with
lower quality medication information
transfer at discharge. The pilot test
summary report titled ‘‘Transfer of
Health Information 2018 Pilot Test
Summary Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
(4) Measure Applications Partnership
(MAP) Review and Related Measures
We included the proposed measure in
the SNF QRP section of the 2018
Measures Under Consideration (MUC)
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list. The MAP conditionally supported
this measure pending NQF
endorsement, noting that the measure
can promote the transfer of important
medication information. The MAP also
suggested that CMS consider a measure
that can be adapted to capture bidirectional information exchange, and
recommended that the medication
information transferred include
important information about
supplements and opioids. More
information about the MAP’s
recommendations for this measure is
available at https://www.quality
forum.org/Publications/2019/02/MAP_
2019_Considerations_for_
Implementing_Measures_Final_Report__PAC–LTC.aspx.
As part of the measure development
and selection process, we also identified
one NQF-endorsed quality measure
similar to the proposed measure, titled
Documentation of Current Medications
in the Medical Record (NQF #0419,
CMS eCQM ID: CMS68v8). This
measure was adopted as one of the
recommended adult core clinical quality
measures for eligible professionals for
the EHR Incentive Program beginning in
2014, and was also adopted under the
Merit-based Incentive Payment System
(MIPS) quality performance category
beginning in 2017. The measure is
calculated based on the percentage of
visits for patients aged 18 years and
older for which the eligible professional
or eligible clinician attests to
documenting a list of current
medications using all resources
immediately available on the date of the
encounter.
The proposed Transfer of Health
Information to the Provider–Post-Acute
Care (PAC) measure addresses the
transfer of information whereas the
NQF-endorsed measure #0419 assesses
the documentation of medications, but
not the transfer of such information.
This is important as the proposed
measure assesses for the transfer of
medication information for the
proposed measure calculation. Further,
the proposed measure utilizes
standardized patient assessment data
elements (SPADEs), which is a
requirement for measures specified
under the Transfer of Health
Information measure domain under
section 1899B(c)(1)(E) of the Act,
whereas NQF #0419 does not.
After review of the NQF-endorsed
measure, we determined that the
proposed Transfer of Health Information
to the Provider–Post-Acute Care (PAC)
measure better addresses the Transfer of
Health Information measure domain,
which requires that at least some of the
data used to calculate the measure be
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collected as standardized patient
assessment data through the post-acute
care assessment instruments. Section
1899B(e)(2)(A) of the Act requires that
any measure specified by the Secretary
be endorsed by the entity with a
contract under section 1890(a) of the
Act, which is currently the National
Quality Form (NQF). However, when a
feasible and practical measure has not
been NQF endorsed for a specified area
or medical topic determined appropriate
by the Secretary, section 1899B(e)(2)(B)
of the Act allows the Secretary to
specify a measure that is not NQF
endorsed as long as due consideration is
given to the measures that have been
endorsed or adopted by a consensus
organization identified by the Secretary.
For the reasons discussed above, we
believe that there is currently no
feasible NQF-endorsed measure that we
could adopt under section
1899B(c)(1)(E) of the Act. However, we
note that we intend to submit the
proposed measure to the NQF for
consideration of endorsement when
feasible.
(5) Quality Measure Calculation
The proposed Transfer of Health
Information to the Provider–Post-Acute
Care (PAC) quality measure is
calculated as the proportion of resident
stays with a discharge assessment
indicating that a current reconciled
medication list was provided to the
subsequent provider at the time of
discharge. The proposed measure
denominator is the total number of SNF
resident stays, ending in discharge to a
‘‘subsequent provider,’’ which is
defined as a short-term general acutecare hospital, a skilled nursing facility
(SNF), intermediate care (intellectual
and developmental disabilities
providers), home under care of an
organized home health service
organization or hospice, hospice in an
institutional facility, an inpatient
rehabilitation facility (IRF), an LTCH, a
Medicaid nursing facility, an inpatient
psychiatric facility, or a critical access
hospital (CAH). These health care
providers were selected for inclusion in
the denominator because they are
identified as subsequent providers on
the discharge destination item that is
currently included on the resident
assessment instrument minimum data
set (MDS), the current version being
MDS 3.0. The proposed measure
numerator is the number of SNF
resident stays with an MDS discharge
assessment indicating a current
reconciled medication list was provided
to the subsequent provider at the time
of discharge. For additional technical
information about this proposed
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measure, we refer readers to the
document titled, ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html. The data source for the
proposed quality measure is the MDS
assessment instrument for SNF
residents.
For more information about the data
submission requirements we are
proposing for this measure, we refer
readers to section VI.A.8.c. of this
proposed rule.
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b. Proposed Transfer of Health
Information to the Patient–Post-Acute
Care (PAC) Measure
Beginning with the FY 2022 SNF
QRP, we are proposing to adopt the
Transfer of Health Information to the
Patient–Post-Acute Care (PAC) measure,
a measure that satisfies the IMPACT Act
domain of Transfer of Health
Information, with data collection for
discharges beginning October 1, 2020.
This process-based measure assesses
whether or not a current reconciled
medication list was provided to the
patient, family, or caregiver when the
patient was discharged from a PAC
setting to a private home/apartment, a
board and care home, assisted living, a
group home, transitional living or home
under care of an organized home health
service organization, or a hospice.
(1) Background
In 2013, 22.3 percent of all acute
hospital discharges were discharged to
PAC settings, including 11 percent who
were discharged to home under the care
of a home health agency.54 Of the
Medicare FFS beneficiaries with a SNF
stay in fiscal year 2017, an estimated 11
percent were discharged home with
home health services, 41 percent were
discharged home with self-care, and 0.2
percent were discharged with home
hospice services.55
The communication of health
information, such as a reconciled
medication list, is critical to ensuring
safe and effective patient transitions
from health care settings to home and/
or other community settings. Incomplete
or missing health information, such as
54 Tian, W. ‘‘An all-payer view of hospital
discharge to postacute care,’’ May 2016. Available
at https://www.hcup-us.ahrq.gov/reports/statbriefs/
sb205-Hospital-Discharge-Postacute-Care.jsp.
55 RTI International analysis of Medicare claims
data for index stays in SNF 2017. (RTI program
reference: IB55).
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medication information, increases the
likelihood of a patient safety risk, often
life-threatening.56 57 58 59 60 Individuals
who use PAC care services are
particularly vulnerable to adverse health
outcomes due to their higher likelihood
of having multiple comorbid chronic
conditions, polypharmacy, and
complicated transitions between care
settings.61 62 Upon discharge to home,
individuals in PAC settings may be
faced with numerous medication
changes, new medication regimes, and
follow-up details.63 64 65 The efficient
and effective communication and
56 Kwan, J.L., Lo, L., Sampson, M., & Shojania,
K.G., ‘‘Medication reconciliation during transitions
of care as a patient safety strategy: a systematic
review,’’ Annals of Internal Medicine, 2013, Vol.
158(5), pp. 397–403.
57 Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ‘‘Effect
of admission medication reconciliation on adverse
drug events from admission medication changes,’’
Archives of Internal Medicine, 2011, Vol. 171(9),
pp. 860–861.
58 Bell, C.M., Brener, S.S., Gunraj, N., Huo, C.,
Bierman, A.S., Scales, D.C., & Urbach, D.R.,
‘‘Association of ICU or hospital admission with
unintentional discontinuation of medications for
chronic diseases,’’ JAMA, 2011, Vol. 306(8), pp.
840–847.
59 Basey, A.J., Krska, J., Kennedy, T.D., &
Mackridge, A.J., ‘‘Prescribing errors on admission to
hospital and their potential impact: a mixedmethods study,’’ BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17–25.
60 Desai, R., Williams, C.E., Greene, S.B., Pierson,
S., & Hansen, R.A., ‘‘Medication errors during
patient transitions into nursing homes:
characteristics and association with patient harm,’’
The American Journal of Geriatric
Pharmacotherapy, 2011, Vol. 9(6), pp. 413–422.
61 Brody, A.A., Gibson, B., Tresner-Kirsch, D.,
Kramer, H., Thraen, I., Coarr, M.E., & Rupper, R.
‘‘High prevalence of medication discrepancies
between home health referrals and Centers for
Medicare and Medicaid Services home health
certification and plan of care and their potential to
affect safety of vulnerable elderly adults,’’ Journal
of the American Geriatrics Society, 2016, Vol.
64(11), pp. e166–e170.
62 Chhabra, P.T., Rattinger, G.B., Dutcher, S.K.,
Hare, M.E., Parsons, K., L., & Zuckerman, I.H.,
‘‘Medication reconciliation during the transition to
and from long-term care settings: a systematic
review,’’ Res Social Adm Pharm, 2012, Vol. 8(1),
pp. 60–75.
63 Brody, A.A., Gibson, B., Tresner-Kirsch, D.,
Kramer, H., Thraen, I., Coarr, M.E., & Rupper, R.
‘‘High prevalence of medication discrepancies
between home health referrals and Centers for
Medicare and Medicaid Services home health
certification and plan of care and their potential to
affect safety of vulnerable elderly adults,’’ Journal
of the American Geriatrics Society, 2016, Vol.
64(11), pp. e166–e170.
64 Bell, C.M., Brener, S.S., Gunraj, N., Huo, C.,
Bierman, A.S., Scales, D.C., & Urbach, D.R.,
‘‘Association of ICU or hospital admission with
unintentional discontinuation of medications for
chronic diseases,’’ JAMA, 2011, Vol. 306(8), pp.
840–847.
65 Sheehan, O.C., Kharrazi, H., Carl, K.J., Leff, B.,
Wolff, J.L., Roth, D.L., Gabbard, J., & Boyd, C.M.,
‘‘Helping older adults improve their medication
experience (HOME) by addressing medication
regimen complexity in home healthcare,’’ Home
Healthcare Now. 2018, Vol. 36(1) pp. 10–19.
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coordination of medication information
may be critical to prevent potentially
deadly adverse effects. When care
coordination activities enhance care
transitions, these activities can reduce
duplication of care services and costs of
care, resolve conflicting care plans, and
prevent medical errors.66 67
Finally, the transfer of a patient’s
discharge medication information to the
patient, family, or caregiver is common
practice and supported by discharge
planning requirements for participation
in Medicare and Medicaid programs.68 69
Most PAC EHR systems generate a
discharge medication list to promote
patient participation in medication
management, which has been shown to
be potentially useful for improving
patient outcomes and transitional
care.70
(2) Stakeholder and Technical Expert
Panel (TEP) Input
The proposed measure was developed
after consideration of feedback we
received from stakeholders and four
TEPs convened by our contractors.
Further, the proposed measure was
developed after evaluation of data
collected during two pilot tests we
conducted in accordance with the CMS
MMS Blueprint.
Our measure development contractors
constituted a TEP which met on
September 27, 2016,71 January 27, 2017,
66 Mor, V., Intrator, O., Feng, Z., & Grabowski,
D.C., ‘‘The revolving door of rehospitalization from
skilled nursing facilities,’’ Health Affairs, 2010, Vol.
29(1), pp. 57–64.
67 Starmer, A.J., Sectish, T.C., Simon, D.W.,
Keohane, C., McSweeney, M.E., Chung, E.Y., Yoon,
C.S., Lipsitz, S.R., Wassner, A.J., Harper, M.B., &
Landrigan, C.P., ‘‘Rates of medical errors and
preventable adverse events among hospitalized
children following implementation of a resident
handoff bundle,’’ JAMA, 2013, Vol. 310(21), pp.
2262–2270.
68 CMS, ‘‘Revision to state operations manual
(SOM), Hospital Appendix A—Interpretive
Guidelines for 42 CFR 482.43, Discharge Planning’’
May 17, 2013. Available at https://www.cms.gov/
Medicare/Provider-Enrollment-and-Certification/
SurveyCertificationGenInfo/Downloads/Surveyand-Cert-Letter-13-32.pdf.
69 The State Operations Manual Guidance to
Surveyors for Long Term Care Facilities (Guidance
§ 483.21(c)(1) Rev. 11–22–17) for discharge
planning process. Available at https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/downloads/som107ap_pp_
guidelines_ltcf.pdf.
70 Toles, M., Colon-Emeric, C., Naylor, M.D.,
Asafu-Adjei, J., Hanson, L.C., ‘‘Connect-home:
transitional care of skilled nursing facility patients
and their caregivers,’’ Am Geriatr Soc., 2017, Vol.
65(10), pp. 2322–2328.
71 Technical Expert Panel Summary Report:
Development of two quality measures to satisfy the
Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain
of Transfer of health Information and Care
Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient
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and August 3, 2017 72 to provide input
on a prior version of this measure.
Based on this input, we updated the
measure concept in late 2017 to include
the transfer of a specific component of
health information—medication
information. Our measure development
contractors reconvened this TEP on
April 20, 2018 to seek expert input on
the measure. Overall, the TEP members
supported the proposed measure,
affirming that the measure provides an
opportunity to improve the transfer of
medication information. Most of the
TEP members believed that the measure
could improve the transfer of
medication information to patients,
families, and caregivers. Several TEP
members emphasized the importance of
transferring information to patients and
their caregivers in a clear manner using
plain language. A summary of the April
20, 2018 TEP proceedings titled
‘‘Transfer of Health Information TEP
Meeting 4—June 2018’’ is available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Our measure development contractors
solicited stakeholder feedback on the
proposed measure by requesting
comment on the CMS Measures
Management System Blueprint website,
and accepted comments that were
submitted from March 19, 2018 to May
3, 2018. Several commenters noted the
importance of ensuring that the
instruction provided to patients and
caregivers is clear and understandable
to promote transparent access to
medical record information and meet
the goals of the IMPACT Act. The
summary report for the March 19 to May
3, 2018 public comment period titled
‘‘IMPACT- Medication Profile
Transferred Public Comment Summary
Report’’ is available at https://
www.cms.gov/Medicare/QualityRehabilitation Facilities (IRFs), Long Term Care
Hospitals (LTCHs) and Home Health Agencies
(HHAs). Available at https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-Quality-Initiatives/
Downloads/Transfer-of-Health-Information-TEP_
Summary_Report_Final-June-2017.pdf.
72 Technical Expert Panel Summary Report:
Development of two quality measures to satisfy the
Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain
of Transfer of health Information and Care
Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient
Rehabilitation Facilities (IRFs), Long Term Care
Hospitals (LTCHs) and Home Health Agencies
(HHAs). Available at https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-Quality-Initiatives/
Downloads/Transfer-of-Health-Information-TEPMeetings-2-3-Summary-Report_Final_Feb2018.pdf.
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Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
(3) Pilot Testing
Between June and August 2018, we
held a pilot test involving 24 PAC
facilities/agencies, including five IRFs,
six SNFs, six LTCHs, and seven HHAs.
The 24 pilot sites submitted a total of
801 assessments. Analysis of agreement
between coders within each
participating facility (241 qualifying
pairs) indicated an 87 percent
agreement for this measure. Overall,
pilot testing enabled us to verify its
reliability, components of face validity,
and feasibility of being implemented
across PAC settings. Further, more than
half of the sites that participated in the
pilot test stated, during debriefing
interviews, that the measure could
distinguish facilities or agencies with
higher quality medication information
transfer from those with lower quality
medication information transfer at
discharge. The pilot test summary report
titled ‘‘Transfer of Health Information
2018 Pilot Test Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
(4) Measure Applications Partnership
(MAP) Review and Related Measures
We included the proposed measure in
the SNF QRP section of the 2018 MUC
list. The MAP conditionally supported
this measure pending NQF
endorsement, noting that the measure
can promote the transfer of important
medication information to the patient.
The MAP recommended that providers
transmit medication information to
patients that is easy to understand
because health literacy can impact a
person’s ability to take medication as
directed. More information about the
MAP’s recommendations for this
measure is available at https://
www.qualityforum.org/Publications/
2019/02/MAP_2019_Considerations_
for_Implementing_Measures_Final_
Report_-_PAC-LTC.aspx.
Section 1899B(e)(2)(A) of the Act,
requires that any measure specified by
the Secretary be endorsed by the entity
with a contract under section 1890(a) of
the Act, which is currently the NQF.
However, when a feasible and practical
measure has not been NQF-endorsed for
a specified area or medical topic
determined appropriate by the
Secretary, section 1899B(e)(2)(B) of the
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Act allows the Secretary to specify a
measure that is not NQF-endorsed as
long as due consideration is given to the
measures that have been endorsed or
adopted by a consensus organization
identified by the Secretary. Therefore, in
the absence of any NQF-endorsed
measures that address the proposed
Transfer of Health Information to the
Patient-Post-Acute Care (PAC), which
requires that at least some of the data
used to calculate the measure be
collected as standardized patient
assessment data through the post-acute
care assessment instruments, we believe
that there is currently no feasible NQFendorsed measure that we could adopt
under section 1899B(c)(1)(E) of the Act.
However, we note that we intend to
submit the proposed measure to the
NQF for consideration of endorsement
when feasible.
(5) Quality Measure Calculation
The calculation of the proposed
Transfer of Health Information to the
Patient-Post-Acute Care (PAC) measure
would be based on the proportion of
resident stays with a discharge
assessment indicating that a current
reconciled medication list was provided
to the resident, family, or caregiver at
the time of discharge.
The proposed measure denominator is
the total number of SNF resident stays
ending in discharge to a private home/
apartment, a board and care home,
assisted living, a group home,
transitional living or home under care of
an organized home health service
organization, or a hospice. These
locations were selected for inclusion in
the denominator because they are
identified as home locations on the
discharge destination item that is
currently included on the MDS. The
proposed measure numerator is the
number of SNF resident stays with an
MDS discharge assessment indicating a
current reconciled medication list was
provided to the resident, family, or
caregiver at the time of discharge. For
technical information about this
proposed measure we refer readers to
the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html. Data for the proposed
quality measure would be calculated
using data from the MDS assessment
instrument for SNF residents.
For more information about the data
submission requirements we are
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proposing for this measure, we refer
readers to section VI.A.8.c. of this
proposed rule.
c. Proposed Update to the Discharge to
Community—Post Acute Care (PAC)
Skilled Nursing Facility (SNF) Quality
Reporting Program (QRP) Measure
We are proposing to update the
specifications for the Discharge to
Community—PAC SNF QRP measure to
exclude baseline nursing facility (NF)
residents from the measure. This
measure reports a SNF’s riskstandardized rate of Medicare FFS
residents who are discharged to the
community following a SNF stay, do not
have an unplanned readmission to an
acute care hospital or LTCH in the 31
days following discharge to community,
and who remain alive during the 31
days following discharge to community.
We adopted this measure in the FY 2017
SNF PPS final rule (81 FR 52021
through 52029).
In the FY 2017 SNF PPS final rule (81
FR 52025), we addressed public
comments recommending exclusion of
SNF residents who were baseline NF
residents, as these residents lived in a
NF prior to their SNF stay and may not
be expected to return to the community
following their SNF stay. In the FY 2018
SNF PPS final rule (82 FR 36596), we
addressed public comments expressing
support for a potential future
modification of the measure that would
exclude baseline NF residents;
commenters stated that the exclusion
would result in the measure more
accurately portraying quality of care
provided by SNFs, while controlling for
factors outside of SNF control.
We assessed the impact of excluding
baseline NF residents from the measure
using CY 2015 and CY 2016 data, and
found that this exclusion impacted both
patient- and facility-level discharge to
community rates. We defined baseline
NF residents as SNF residents who had
a long-term NF stay in the 180 days
preceding their hospitalization and SNF
stay, with no intervening community
discharge between the NF stay and
qualifying hospitalization for measure
inclusion. Baseline NF residents
represented 10.4 percent of the measure
population after all measure exclusions
were applied. Observed resident-level
discharge to community rates were
significantly lower for baseline NF
residents (2.37 percent) compared with
non-NF residents (53.32 percent). The
national observed resident-level
discharge to community rate was 48.01
percent when baseline NF residents
were included in the measure,
increasing to 53.32 percent when they
were excluded from the measure. After
excluding baseline NF residents, 38.5
percent of SNFs had an increase in their
risk-standardized discharge to
community rate that exceeded the
increase in the national observed
resident-level discharge to community
rate.
Based on public comments received
and our impact analysis, we are
proposing to exclude baseline NF
residents from the Discharge to
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Community—PAC SNF QRP measure
beginning with the FY 2020 SNF QRP,
with baseline NF residents defined as
SNF residents who had a long-term NF
stay in the 180 days preceding their
hospitalization and SNF stay, with no
intervening community discharge
between the NF stay and
hospitalization.
For additional technical information
regarding the Discharge to
Community—PAC SNF QRP measure,
including technical information about
the proposed exclusion, we refer readers
to the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Resident
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
We are inviting public comment on
this proposal.
5. SNF QRP Quality Measures, Measure
Concepts, and Standardized Patient
Assessment Data Elements Under
Consideration for Future Years: Request
for Information
We are seeking input on the
importance, relevance, appropriateness,
and applicability of each of the
measures, standardized patient
assessment data elements (SPADEs),
and concepts under consideration listed
in the Table 13 for future years in the
SNF QRP.
TABLE 13—FUTURE MEASURES, MEASURE CONCEPTS, AND STANDARDIZED PATIENT ASSESSMENT DATA ELEMENTS
(SPADES) UNDER CONSIDERATION FOR THE SNF QRP
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Assessment-Based Quality Measures and Measure Concepts:
Functional maintenance outcomes.
Opioid use and frequency.
Exchange of electronic health information and interoperability.
Claims-Based:
Healthcare-Associated Infections in Skilled Nursing Facility (SNF)—claims-based.
Standardized Patient Assessment Data Elements (SPADEs):
Cognitive complexity, such as executive function and memory.
Dementia.
Bladder and bowel continence including appliance use and episodes of incontinence.
Care preferences, advance care directives, and goals of care.
Caregiver Status.
Veteran Status.
Health disparities and risk factors, including education, sex and gender identity, and sexual orientation.
While we will not be responding to
specific comments submitted in
response to this Request for Information
in the FY 2020 SNF PPS final rule, we
intend to use this input to inform our
future measure and SPADE
development efforts
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6. Proposed Standardized Patient
Assessment Data Reporting Beginning
With the FY 2022 SNF QRP
standardized patient 73 assessment data
(SPADE) required under section
Section 1888(e)(6)(B)(i)(III) of the Act
requires that, for fiscal years 2019 and
each subsequent year, SNFs must report
73 In the FY 2018 SNF PPS final rule, we used the
term ‘‘standardized resident assessment data’’ to
refer to standardized assessment data elements
collected from SNF residents. However, in this
proposed rule and going forward, we will use the
term ‘‘standardized patient assessment data’’ to
refer to the collect of SPADEs from SNF residents.
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1899B(b)(1) of the Act. Section
1899B(a)(1)(C) of the Act requires, in
part, the Secretary to modify the PAC
assessment instruments in order for
PAC providers, including SNFs, to
submit SPADEs under the Medicare
program. Section 1899B(b)(1)(A) of the
Act requires PAC providers to submit
SPADEs under applicable reporting
provisions (which, for SNFs, is the SNF
QRP) with respect to the admission and
discharge of an individual (and more
frequently as the Secretary deems
appropriate), and section 1899B(b)(1)(B)
of the Act defines standardized patient
assessment data as data required for at
least the quality measures described in
section 1899B(c)(1) of the Act and that
is with respect to the following
categories: (1) Functional status, such as
mobility and self-care at admission to a
PAC provider and before discharge from
a PAC provider; (2) cognitive function,
such as ability to express ideas and to
understand, and mental status, such as
depression and dementia; (3) special
services, treatments, and interventions,
such as need for ventilator use, dialysis,
chemotherapy, central line placement,
and total parenteral nutrition; (4)
medical conditions and comorbidities,
such as diabetes, congestive heart
failure, and pressure ulcers; (5)
impairments, such as incontinence and
an impaired ability to hear, see, or
swallow, and (6) other categories
deemed necessary and appropriate by
the Secretary.
In the FY 2018 SNF PPS proposed
rule (82 FR 21059 through 21076), we
proposed to adopt SPADEs that would
satisfy the first five categories. In the FY
2018 SNF PPS final rule, commenters
expressed support for our adoption of
SPADEs in general, including support
for our broader standardization goal and
support for the clinical usefulness of
specific proposed SPADEs. However,
we did not finalize the majority of our
SPADE proposals in recognition of the
concern raised by many commenters
that we were moving too fast to adopt
the SPADEs and modify our assessment
instruments in light of all of the other
requirements we were also adopting
under the IMPACT Act at that time (82
FR 36598 through 36600). In addition,
we noted our intention to conduct
extensive testing to ensure that the
standardized patient assessment data
elements we select are reliable, valid,
and appropriate for their intended use
(82 FR 36599).
We did, however, finalize the
adoption of SPADEs for two of the
categories described in section
1899B(b)(1)(B) of the Act: (1) Functional
status: Data elements currently reported
by SNFs to calculate the measure
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Application of Percent of Long-Term
Care Hospital Patients with an
Admission and Discharge Functional
Assessment and a Care Plan That
Addresses Function (NQF #2631); and
(2) Medical conditions and
comorbidities: The data elements used
to calculate the pressure ulcer measures,
Percent of Residents or Patients with
Pressure Ulcers That Are New or
Worsened (Short Stay) (NQF #0678) and
the replacement measure, Changes in
Skin Integrity Post-Acute Care: Pressure
Ulcer/Injury. We stated that these data
elements were important for care
planning, known to be valid and
reliable, and already being reported by
SNFs for the calculation of quality
measures.
Since we issued the FY 2018 SNF PPS
final rule, SNFs have had an
opportunity to familiarize themselves
with other new reporting requirements
that we have adopted under the
IMPACT Act. We have also conducted
further testing of the SPADEs, as
described more fully below, and believe
that this testing supports the use of the
SPADEs in our PAC assessment
instruments. Therefore, we are now
proposing to adopt many of the same
SPADEs that we previously proposed to
adopt, along with other SPADEs.
We are proposing that SNFs would be
required to report these SPADEs
beginning with the FY 2022 SNF QRP.
If finalized as proposed, SNFs would be
required to report these data with
respect to SNF admissions and
discharges that occur between October
1, 2020 and December 31, 2020 for the
FY 2022 SNF QRP. Beginning with the
FY 2023 SNF QRP, we propose that
SNFs must report data with respect to
admissions and discharges that occur
during the subsequent calendar year (for
example, CY 2021 for the FY 2023 SNF
QRP, CY 2022 for the FY 2024 SNF
QRP).
We are also proposing that SNFs that
submit the Hearing, Vision, Race, and
Ethnicity SPADEs with respect to
admission only will be deemed to have
submitted those SPADEs with respect to
both admission and discharge, because
it is unlikely that the assessment of
those SPADEs at admission will differ
from the assessment of the same
SPADEs at discharge.
In selecting the proposed SPADEs
below, we considered the burden of
assessment-based data collection and
aimed to minimize additional burden by
evaluating whether any data that is
currently collected through one or more
PAC assessment instruments could be
collected as SPADE. In selecting the
proposed SPADEs below, we also took
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into consideration the following factors
with respect to each data element:
(1) Overall clinical relevance;
(2) Interoperable exchange to facilitate
care coordination during transitions in
care;
(3) Ability to capture medical
complexity and risk factors that can
inform both payment and quality; and
(4) Scientific reliability and validity,
general consensus agreement for its
usability.
In identifying the SPADEs proposed
below, we additionally drew on input
from several sources, including TEPs
held by our data element contractor,
public input, and the results of a recent
National Beta Test of candidate data
elements conducted by our data element
contractor (hereafter ‘‘National Beta
Test’’).
The National Beta Test collected data
from 3,121 patients and residents across
143 LTCHs, SNFs, IRFs, and HHAs from
November 2017 to August 2018 to
evaluate the feasibility, reliability, and
validity of candidate data elements
across PAC settings. The National Beta
Test also gathered feedback on the
candidate data elements from staff who
administered the test protocol in order
to understand usability and workflow of
the candidate data elements. More
information on the methods, analysis
plan, and results for the National Beta
Test are available in the document
titled, ‘‘Development and Evaluation of
Candidate Standardized Patient
Assessment Data Elements: Findings
from the National Beta Test (Volume
2),’’ available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
Further, to inform the proposed
SPADEs, we took into account feedback
from stakeholders, as well as from
technical and clinical experts, including
feedback on whether the candidate data
elements would support the factors
described above. Where relevant, we
also took into account the results of the
Post-Acute Care Payment Reform
Demonstration (PAC PRD) that took
place from 2006 to 2012.
7. Proposed Standardized Patient
Assessment Data by Category
a. Cognitive Function and Mental Status
Data
A number of underlying conditions,
including dementia, stroke, traumatic
brain injury, side effects of medication,
metabolic and/or endocrine imbalances,
delirium, and depression, can affect
cognitive function and mental status in
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PAC patient and resident populations.74
The assessment of cognitive function
and mental status by PAC providers is
important because of the high
percentage of patients and residents
with these conditions,75 and because
these assessments provide opportunity
for improving quality of care.
Symptoms of dementia may improve
with pharmacotherapy, occupational
therapy, or physical activity,76 77 78 and
promising treatments for severe
traumatic brain injury are currently
being tested.79 For older patients and
residents diagnosed with depression,
treatment options to reduce symptoms
and improve quality of life include
antidepressant medication and
psychotherapy,80 81 82 83 and targeted
services, such as therapeutic recreation,
exercise, and restorative nursing, to
increase opportunities for psychosocial
interaction.84
In alignment with our Meaningful
Measures Initiative, accurate assessment
74 National Institute on Aging. (2014). Assessing
Cognitive Impairment in Older Patients. A Quick
Guide for Primary Care Physicians. Retrieved from
https://www.nia.nih.gov/alzheimers/publication/
assessing-cognitive-impairment-older-patients.
75 Gage B., Morley M., Smith L., et al. (2012).
Post-Acute Care Payment Reform Demonstration
(Final report, Volume 4 of 4). Research Triangle
Park, NC: RTI International.
76 Casey D.A., Antimisiaris D., O’Brien J. (2010).
Drugs for Alzheimer’s Disease: Are They Effective?
Pharmacology & Therapeutics, 35, 208–211.
77 Graff M.J., Vernooij-Dassen M.J., Thijssen M.,
Dekker J., Hoefnagels W.H., Rikkert M.G.O. (2006).
Community Based Occupational Therapy for
Patients with Dementia and their Care Givers:
Randomised Controlled Trial. BMJ, 333(7580):
1196.
78 Bherer L., Erickson K.I., Liu-Ambrose T. (2013).
A Review of the Effects of Physical Activity and
Exercise on Cognitive and Brain Functions in Older
Adults. Journal of Aging Research, 657508.
79 Giacino J.T., Whyte J., Bagiella E., et al. (2012).
Placebo-controlled trial of amantadine for severe
traumatic brain injury. New England Journal of
Medicine, 366(9), 819–826.
80 Alexopoulos G.S., Katz I.R., Reynolds C.F. 3rd,
Carpenter D., Docherty J.P., Ross R.W. (2001).
Pharmacotherapy of depression in older patients: a
summary of the expert consensus guidelines.
Journal of Psychiatric Practice, 7(6), 361–376.
81 Arean P.A., Cook B.L. (2002). Psychotherapy
and combined psychotherapy/pharmacotherapy for
late life depression. Biological Psychiatry, 52(3),
293–303.
82 Hollon S.D., Jarrett R.B., Nierenberg A.A.,
Thase M.E., Trivedi M., Rush A.J. (2005).
Psychotherapy and medication in the treatment of
adult and geriatric depression: which monotherapy
or combined treatment? Journal of Clinical
Psychiatry, 66(4), 455–468.
83 Wagenaar D., Colenda C.C., Kreft M., Sawade
J., Gardiner J., Poverejan E. (2003). Treating
depression in nursing homes: practice guidelines in
the real world. J Am Osteopath Assoc. 103(10), 465–
469.
84 Crespy S.D., Van Haitsma K., Kleban M., Hann
C.J. Reducing Depressive Symptoms in Nursing
Home Residents: Evaluation of the Pennsylvania
Depression Collaborative Quality Improvement
Program. J Healthc Qual. 2016. Vol. 38, No. 6, pp.
e76–e88.
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of cognitive function and mental status
of patients and residents in PAC is
expected to make care safer by reducing
harm caused in the delivery of care;
promote effective prevention and
treatment of chronic disease; strengthen
person and family engagement as
partners in their care; and promote
effective communication and
coordination of care. For example,
standardized assessment of cognitive
function and mental status of patients
and residents in PAC will support
establishing a baseline for identifying
changes in cognitive function and
mental status (for example, delirium),
anticipating the patient’s or resident’s
ability to understand and participate in
treatments during a PAC stay, ensuring
patient and resident safety (for example,
risk of falls), and identifying appropriate
support needs at the time of discharge
or transfer. Standardized patient
assessment data elements will enable or
support clinical decision-making and
early clinical intervention; personcentered, high quality care through
facilitating better care continuity and
coordination; better data exchange and
interoperability between settings; and
longitudinal outcome analysis.
Therefore, reliable standardized patient
assessment data elements assessing
cognitive function and mental status are
needed in order to initiate a
management program that can optimize
a patient’s or resident’s prognosis and
reduce the possibility of adverse events.
The data elements related to cognitive
function and mental status were first
proposed as standardized patient
assessment data elements in the FY
2018 SNF PPS proposed rule (82 FR
21060 through 21063). In response to
our proposals, a few commenters noted
that the proposed data elements did not
capture some dimensions of cognitive
function and mental status, such as
functional cognition, communication,
attention, concentration, and agitation.
One commenter also suggested that
other cognitive assessments should be
considered for standardization. Another
commenter stated support for the
standardized assessment of cognitive
function and mental status, because it
could support appropriate use of skilled
therapy for beneficiaries with
degenerative conditions, such as
dementia, and appropriate use of
medications for behavioral and
psychological symptoms of dementia.
We are inviting comment on our
proposals to collect as standardized
patient assessment data the following
data with respect to cognitive function
and mental status.
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• Brief Interview for Mental Status
(BIMS)
We are proposing that the data
elements that comprise the BIMS meet
the definition of standardized patient
assessment data with respect to
cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the
Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21060 through
21061), dementia and cognitive
impairment are associated with longterm functional dependence and,
consequently, poor quality of life and
increased health care costs and
mortality.85 This makes assessment of
mental status and early detection of
cognitive decline or impairment critical
in the PAC setting. The intensity of
routine nursing care is higher for
patients and residents with cognitive
impairment than those without, and
dementia is a significant variable in
predicting readmission after discharge
to the community from PAC
providers.86
The BIMS is a performance-based
cognitive assessment screening tool that
assesses repetition, recall with and
without prompting, and temporal
orientation. The data elements that
make up the BIMS are seven questions
on the repetition of three words,
temporal orientation, and recall that
result in a cognitive function score. The
BIMS was developed to be a brief,
objective screening tool, with a focus on
learning and memory. As a brief
screener, the BIMS was not designed to
diagnose dementia or cognitive
impairment, but rather to be a relatively
quick and easy to score assessment that
could identify cognitively impaired
patients as well as those who may be at
risk for cognitive decline and require
further assessment. It is currently in use
in two of the PAC assessments: The
MDS used by SNFs and the IRF–PAI
used by IRFs. For more information on
the BIMS, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
85 Agu
¨ ero-Torres, H., Fratiglioni, L., Guo, Z.,
Viitanen, M., von Strauss, E., & Winblad, B. (1998).
‘‘Dementia is the major cause of functional
dependence in the elderly: 3-year follow-up data
from a population-based study.’’ Am J of Public
Health 88(10): 1452–1456.
86 RTI International. Proposed Measure
Specifications for Measures Proposed in the FY
2017 IRF QRP NPRM. Research Triangle Park, NC.
2016.
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The data elements that comprise the
BIMS were first proposed as
standardized patient assessment data
elements in the FY 2018 SNF PPS
proposed rule (82 FR 21060 through
21061). In that proposed rule, we stated
that the proposal was informed by input
we received through a call for input
published on the CMS Measures
Management System Blueprint website.
Input submitted from August 12 to
September 12, 2016 expressed support
for use of the BIMS, noting that it is
reliable, feasible to use across settings,
and will provide useful information
about patients and residents. We also
stated that the data collected through
the BIMS will provide a clearer picture
of patient or resident complexity, help
with the care planning process, and be
useful during care transitions and when
coordinating across providers. A
summary report for the August 12 to
September 12, 2016 public comment
period titled ‘‘SPADE August 2016
Public Comment Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, a few
commenters supported the use of the
BIMS as standardized patient
assessment data elements. Other
commenters were critical of the BIMS,
noting its limitations for assessing mild
cognitive impairment and functional
cognition. Another stated that the BIMS
should be administered with respect to
discharge, as well as admission to
capture changes during the stay. One
expressed concern that the BIMS cannot
be completed by patients and residents
who are unable to communicate.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the BIMS
was included in the National Beta Test
of candidate data elements conducted
by our data element contractor from
November 2017 to August 2018. Results
of this test found the BIMS to be feasible
and reliable for use with PAC patients
and residents. More information about
the performance of the BIMS in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
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IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018, for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements and the TEP supported the
assessment of patient or resident
cognitive status at both admission and
discharge. A summary of the September
17, 2018 TEP meeting titled ‘‘SPADE
Technical Expert Panel Summary (Third
Convening)’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
Some commenters also expressed
concern that the BIMS, if used alone,
may not be sensitive enough to capture
the range of cognitive impairments,
including mild cognitive impairment
(MCI). A summary of the public input
received from the November 27, 2018
stakeholder meeting titled ‘‘Input on
Standardized Patient Assessment Data
Elements (SPADEs) Received After
November 27, 2018 Stakeholder
Meeting’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
We understand the concerns raised by
stakeholders that BIMS, if used alone,
may not be sensitive enough to capture
the range of cognitive impairments,
including functional cognition and MCI,
but note that the purpose of the BIMS
data elements as SPADEs is to screen for
cognitive impairment in a broad
population. We also acknowledge that
further cognitive tests may be required
based on a patient’s condition and will
take this feedback into consideration in
the development of future standardized
assessment data elements. However,
taking together the importance of
assessing for cognitive status,
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stakeholder input, and strong test
results, we are proposing that the BIMS
data elements meet the definition of
standardized patient assessment data
with respect to cognitive function and
mental status under section
1899B(b)(1)(B)(ii) of the Act and to
adopt the BIMS as standardized patient
assessment data for use in the SNF QRP.
• Confusion Assessment Method (CAM)
We are proposing that the data
elements that comprise the Confusion
Assessment Method (CAM) meet the
definition of standardized patient
assessment data with respect to
cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the
Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21061), the CAM
was developed to identify the signs and
symptoms of delirium. It results in a
score that suggests whether a patient or
resident should be assigned a diagnosis
of delirium. Because patients and
residents with multiple comorbidities
receive services from PAC providers, it
is important to assess delirium, which is
associated with a high mortality rate
and prolonged duration of stay in
hospitalized older adults.87 Assessing
these signs and symptoms of delirium is
clinically relevant for care planning by
PAC providers.
The CAM is a patient assessment that
screens for overall cognitive
impairment, as well as distinguishes
delirium or reversible confusion from
other types of cognitive impairment.
The CAM is currently in use in two of
the PAC assessments: A four-item
version of the CAM is used in the MDS
in SNFs and a six-item version of the
CAM is used in the LTCH CARE Data
Set (LCDS) in LTCHs. We are proposing
the four-item version of the CAM that
assesses acute change in mental status,
inattention, disorganized thinking, and
altered level of consciousness. For more
information on the CAM, we refer
readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
The data elements that comprise the
CAM were first proposed as
standardized patient assessment data
87 Fick, D.M., Steis, M.R., Waller, J.L., & Inouye,
S.K. (2013). ‘‘Delirium superimposed on dementia
is associated with prolonged length of stay and poor
outcomes in hospitalized older adults.’’ J of
Hospital Med 8(9): 500–505.
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elements in the FY 2018 SNF PPS
proposed rule (82 FR 21061). In that
proposed rule, we stated that the
proposal was informed by input we
received on the CAM through a call for
input published on the CMS Measures
Management System Blueprint website.
Input submitted from August 12 to
September 12, 2016 expressed support
for use of the CAM, noting that it would
provide important information for care
planning and care coordination and,
therefore, contribute to quality
improvement. We also stated that those
commenters had noted the CAM is
particularly helpful in distinguishing
delirium and reversible confusion from
other types of cognitive impairment. A
summary report for the August 12 to
September 12, 2016 public comment
period titled ‘‘SPADE August 2016
Public Comment Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, a few
commenters supported the use of the
CAM as standardized patient
assessment data elements, with one
noting that it distinguishes delirium or
reversible confusion from other types of
cognitive impairments to share across
settings for care coordination.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the CAM
was included in the National Beta Test
of candidate data elements conducted
by our data element contractor from
November 2017 to August 2018. Results
of this test found the CAM to be feasible
and reliable for use with PAC patients
and residents. More information about
the performance of the CAM in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although they did not
specifically discuss the CAM data
elements, the TEP supported the
assessment of patient or resident
cognitive status with respect to both
admission and discharge. A summary of
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the September 17, 2018 TEP meeting
titled ‘‘SPADE Technical Expert Panel
Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for delirium, stakeholder
input, and strong test results, we are
proposing that the CAM data elements
meet the definition of standardized
patient assessment data with respect to
cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the
Act and to adopt the CAM as
standardized patient assessment data
elements for use in the SNF QRP.
b. Patient Health Questionnaire—2 to 9
(PHQ–2 to 9)
We are proposing that the Patient
Health Questionnaire—2 to 9 (PHQ–2 to
9) data elements meet the definition of
standardized patient assessment data
with respect to cognitive function and
mental status under section
1899B(b)(1)(B)(ii) of the Act. The
proposed data elements are based on the
PHQ–2 mood interview, which focuses
on only the two cardinal symptoms of
depression, and the longer PHQ–9 mood
interview, which assesses presence and
frequency of nine signs and symptoms
of depression. The name of the data
element, the PHQ–2 to 9, refers to an
embedded a skip pattern that transitions
residents with a threshold level of
symptoms in the PHQ–2 to the longer
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assessment of the PHQ–9. The skip
pattern is described further below.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21062 through
21063), depression is a common and
under-recognized mental health
condition. Assessments of depression
help PAC providers better understand
the needs of their patients and residents
by: Prompting further evaluation after
establishing a diagnosis of depression;
elucidating the patient’s or resident’s
ability to participate in therapies for
conditions other than depression during
their stay; and identifying appropriate
ongoing treatment and support needs at
the time of discharge.
The proposed PHQ–2 to 9 is based on
the PHQ–9 mood interview. The PHQ–
2 consists of questions about only the
first two symptoms addressed in the
PHQ–9: Depressed mood and anhedonia
(inability to feel pleasure), which are the
cardinal symptoms of depression. The
PHQ–2 has performed well as both a
screening tool for identifying
depression, to assess depression
severity, and to monitor patient mood
over time.88 89 If a patient demonstrates
signs of depressed mood and anhedonia
under the PHQ–2, then the patient is
administered the lengthier PHQ–9. This
skip pattern (also referred to as a
gateway) is designed to reduce the
length of the interview assessment for
residents who fail to report the cardinal
symptoms of depression. The design of
the PHQ–2 to 9 reduces the burden that
would be associated with the full PHQ–
9, while ensuring that patients with
indications of depressive symptoms
based on the PHQ–2 receive the longer
assessment.
Components of the proposed data
elements are currently used in the
OASIS for HHAs (PHQ–2) and the MDS
for SNFs (PHQ–9). We are proposing
altering the administration instructions
for the existing data elements to adopt
the PHQ–2 to 9 gateway logic, meaning
that administration of the full PHQ–9 is
contingent on resident responses to
questions about the cardinal symptoms
of depression. For more information on
the PHQ–2 to 9, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/Quality88 Li, C., Friedman, B., Conwell, Y., & Fiscella, K.
(2007). ‘‘Validity of the Patient Health
Questionnaire 2 (PHQ–2) in identifying major
depression in older people.’’ J of the A Geriatrics
Society, 55(4): 596–602.
89 Lo
¨ we, B., Kroenke, K., & Gra¨fe, K. (2005).
‘‘Detecting and monitoring depression with a twoitem questionnaire (PHQ–2).’’ J of Psychosomatic
Research, 58(2): 163–171.
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IMPACT-Act-Downloads-andVideos.html.
The PHQ–2 data elements were first
proposed as SPADEs in the FY 2018
SNF PPS proposed rule (82 FR 21062
through 21063). In that proposed rule
we stated that the proposal was
informed by input we received from the
TEP convened by our data element
contractor on April 6 and 7, 2016. The
TEP members particularly noted that the
brevity of the PHQ–2 made it feasible to
administer with low burden for both
assessors and PAC patients or residents.
A summary of the April 6 and 7, 2016
TEP meeting titled ‘‘SPADE Technical
Expert Panel Summary (First
Convening)’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html. That proposed rule was
also informed by public input through
a call for input published on the CMS
Measures Management System
Blueprint website. Input was submitted
from August 12 to September 12, 2016
on three versions of the PHQ depression
screener: The PHQ–2; the PHQ–9; and
the PHQ–2 to 9 with the skip pattern
design. Many commenters provided
feedback on using the PHQ–2 for the
assessment of mood. Overall,
commenters believed that collecting
these data elements across PAC provider
types was appropriate, given the role
that depression plays in well-being.
Several commenters expressed support
for an approach that would use PHQ–2
as a gateway to the longer PHQ–9 while
still potentially reducing burden on
most patients and residents, as well as
test administrators, and ensuring the
administration of the PHQ–9, which
exhibits higher specificity,90 for patients
and residents who showed signs and
symptoms of depression on the PHQ–2.
A summary report for the August 12 to
September 12, 2016 public comment
period titled ‘‘SPADE August 2016
Public Comment Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of90 Arroll B., Goodyear-Smith F., Crengle S., Gunn
J., Kerse N., Fishman T., et al. Validation of PHQ–
2 and PHQ–9 to screen for major depression in the
primary care population. Annals of family
medicine. 2010;8(4):348–353. doi: 10.1370/
afm.1139 pmid:20644190; PubMed Central PMCID:
PMC2906530.
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2014/IMPACT-Act-Downloads-andVideos.html.
In response to our proposal to use the
PHQ–2 in the FY 2018 SNF PPS
proposed rule, a few commenters
supported screening residents for
depression with the PHQ–2. One
commenter opposed the replacement of
the PHQ–9 on the MDS with PHQ–2
because of the clinical significance of
depression on quality of care and
resident outcomes in the SNF
population. Another expressed concern
about the use of multi-step ‘‘gateway’’
questions, because use of the PHQ–2
and PHQ–9 may result in data not being
standardized across settings and
providers gathering data unrelated to
the appropriateness of care.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the PHQ–2
to 9 was included in the National Beta
Test of candidate data elements
conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the PHQ–2 to 9 to be feasible and
reliable for use with PAC patients and
residents. More information about the
performance of the PHQ–2 to 9 in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the PHQ–2 to 9. The
TEP was supportive of the PHQ–2 to 9
data element set as a screener for signs
and symptoms of depression. The TEP’s
discussion noted that symptoms
evaluated by the full PHQ–9 (for
example, concentration, sleep, appetite)
had relevance to care planning and the
overall well-being of the patient or
resident, but that the gateway approach
of the PHQ–2 to 9 would be appropriate
as a depression screening assessment, as
it depends on the well-validated PHQ–
2 and focuses on the cardinal symptoms
of depression. A summary of the
September 17, 2018 TEP meeting titled
‘‘SPADE Technical Expert Panel
Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
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We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for depression, stakeholder
input, and strong test results, we are
proposing that the PHQ–2 to 9 data
elements meet the definition of
standardized patient assessment data
with respect to cognitive function and
mental status under section
1899B(b)(1)(B)(ii) of the Act and to
adopt the PHQ–2 to 9 data elements as
standardized patient assessment data
elements for use in the SNF QRP.
c. Special Services, Treatments, and
Interventions Data
Special services, treatments, and
interventions performed in PAC can
have a major effect on an individual’s
health status, self-image, and quality of
life. The assessment of these special
services, treatments, and interventions
in PAC is important to ensure the
continuing appropriateness of care for
the patients and residents receiving
them, and to support care transitions
from one PAC provider to another, an
acute care hospital, or discharge. In
alignment with our Meaningful
Measures Initiative, accurate assessment
of special services, treatments, and
interventions of patients and residents
served by PAC providers is expected to
make care safer by reducing harm
caused in the delivery of care; promote
effective prevention and treatment of
chronic disease; strengthen person and
family engagement as partners in their
care; and promote effective
communication and coordination of
care.
For example, standardized assessment
of special services, treatments, and
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interventions used in PAC can promote
patient and resident safety through
appropriate care planning (for example,
mitigating risks such as infection or
pulmonary embolism associated with
central intravenous access), and
identifying life-sustaining treatments
that must be continued, such as
mechanical ventilation, dialysis,
suctioning, and chemotherapy, at the
time of discharge or transfer.
Standardized assessment of these data
elements will enable or support:
Clinical decision-making and early
clinical intervention; person-centered,
high quality care through, for example,
facilitating better care continuity and
coordination; better data exchange and
interoperability between settings; and
longitudinal outcome analysis.
Therefore, reliable data elements
assessing special services, treatments,
and interventions are needed to initiate
a management program that can
optimize a patient’s or resident’s
prognosis and reduce the possibility of
adverse events.
A TEP convened by our data element
contractor provided input on all of the
proposed data elements for special
services, treatments, and interventions.
In a meeting held on January 5 and 6,
2017, this TEP found that these data
elements are appropriate for
standardization because they would
provide useful clinical information to
inform care planning and care
coordination. The TEP affirmed that
assessment of these services and
interventions is standard clinical
practice, and that the collection of these
data by means of a list and checkbox
format would conform with common
workflow for PAC providers. A
summary of the January 5 and 6, 2017
TEP meeting titled ‘‘SPADE Technical
Expert Panel Summary (Second
Convening)’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Comments on the category of special
services, treatments, and interventions
were also submitted by stakeholders
during the FY 2018 SNF PPS proposed
rule (82 FR 21063 through 21073) public
comment period. A comment across all
special services, treatments, and
interventions data elements requested
that the additional reporting burden of
the special services, treatments, and
interventions data elements be
addressed in payment calculations.
Another comment submitted for several
special services, treatments, and
interventions data elements requested
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additional time be allowed before the
providers are required to submit these
data. One commenter expressed concern
about increased reporting burden of the
data elements proposed in FY 2018
because they would require an
additional look-back time frame. Several
commenters supported the inclusion of
nutritional data elements as
standardized data elements noting their
importance in capturing information on
care coordination and safe care
transitions. One commenter noted the
limitations of the nutritional data
elements, namely that they do not
capture information on swallowing or
the clinical rationale for feeding/
nutrition needs.
Information on data element
performance in the National Beta Test,
which collected data between November
2017 and August 2018, is reported
within each data element proposal
below. Clinical staff who participated in
the National Beta Test supported these
data elements because of their
importance in conveying patient or
resident significant health care needs,
complexity, and progress. However,
clinical staff also noted that, despite the
simple ‘‘check box’’ format of these data
element, they sometimes needed to
consult multiple information sources to
determine a patient’s or resident’s
treatments.
We are inviting comment on our
proposals to collect as standardized
patient assessment data the following
data with respect to special services,
treatments, and interventions.
(1) Cancer Treatment: Chemotherapy
(IV, Oral, Other)
We are proposing that the
Chemotherapy (IV, Oral, Other) data
element meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21063 through
21064), chemotherapy is a type of
cancer treatment that uses drugs to
destroy cancer cells. It is sometimes
used when a patient has a malignancy
(cancer), which is a serious, often lifethreatening or life-limiting condition.
Both intravenous (IV) and oral
chemotherapy have serious side effects,
including nausea/vomiting, extreme
fatigue, risk of infection due to a
suppressed immune system, anemia,
and an increased risk of bleeding due to
low platelet counts. Oral chemotherapy
can be as potent as chemotherapy given
by IV, and can be significantly more
convenient and less resource-intensive
to administer. Because of the toxicity of
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these agents, special care must be
exercised in handling and transporting
chemotherapy drugs. IV chemotherapy
is administered either peripherally, or
more commonly, given via an
indwelling central line, which raises the
risk of bloodstream infections. Given the
significant burden of malignancy, the
resource intensity of administering
chemotherapy, and the side effects and
potential complications of these highlytoxic medications, assessing the receipt
of chemotherapy is important in the
PAC setting for care planning and
determining resource use. The need for
chemotherapy predicts resource
intensity, both because of the
complexity of administering these
potent, toxic drug combinations under
specific protocols, and because of what
the need for chemotherapy signals about
the patient’s underlying medical
condition. Furthermore, the resource
intensity of IV chemotherapy is higher
than for oral chemotherapy, as the
protocols for administration and the
care of the central line (if present) for IV
chemotherapy require significant
resources.
The Chemotherapy (IV, Oral, Other)
data element consists of a principal data
element (Chemotherapy) and three
response option sub-elements: IV
chemotherapy, which is generally
resource-intensive; Oral chemotherapy,
which is less invasive and generally
requires less intensive administration
protocols; and a third category, Other,
provided to enable the capture of other
less common chemotherapeutic
approaches. This third category is
potentially associated with higher risks
and is more resource intensive due to
chemotherapy delivery by other routes
(for example, intraventricular or
intrathecal). If the assessor indicates
that the resident is receiving
chemotherapy on the principal
Chemotherapy data element, the
assessor would then indicate by which
route or routes (for example, IV, Oral,
Other) the chemotherapy is
administered.
A single Chemotherapy data element
that does not include the proposed three
sub-elements is currently in use in the
MDS in SNFs. We are proposing to
expand the existing Chemotherapy data
element in the MDS to include subelements for IV, Oral, and Other. For
more information on the Chemotherapy
(IV, Oral, Other) data element, we refer
readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-Acute-
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The Chemotherapy data element was
first proposed as a standardized patient
assessment data element in the FY 2018
SNF PPS proposed rule (82 FR 21063
through 21064). In that proposed rule,
we stated that the proposal was
informed by input we received through
a call for input published on the CMS
Measures Management System
Blueprint website. Input submitted from
August 12 to September 12, 2016
expressed support for the IV
Chemotherapy data element and
suggested it be included as standardized
patient assessment data. We also stated
that those commenters had noted that
assessing the use of chemotherapy
services is relevant to share across the
care continuum to facilitate care
coordination and care transitions and
noted the validity of the data element.
Commenters also noted the importance
of capturing all types of chemotherapy,
regardless of route, and stated that
collecting data only on patients and
residents who received chemotherapy
by IV would limit the usefulness of this
standardized data element. A summary
report for the August 12 to September
12, 2016 public comment period titled
‘‘SPADE August 2016 Public Comment
Summary Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
Chemotherapy (IV, Oral, Other) as
standardized patient assessment data
elements.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the
Chemotherapy data element was
included in the National Beta Test of
candidate data elements conducted by
our data element contractor from
November 2017 to August 2018. Results
of this test found the Chemotherapy
data element to be feasible and reliable
for use with PAC patients and residents.
More information about the
performance of the Chemotherapy data
element in the National Beta Test can be
found in the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
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IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP members
did not specifically discuss the
Chemotherapy data element, the TEP
members supported the assessment of
the special services, treatments, and
interventions included in the National
Beta Test with respect to both admission
and discharge. A summary of the
September 17, 2018 TEP meeting titled
‘‘SPADE Technical Expert Panel
Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for chemotherapy, stakeholder
input, and strong test results, we are
proposing, we are proposing that the
Chemotherapy (IV, Oral, Other) data
element with a principal data element
and three sub-elements meet the
definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Chemotherapy (IV,
Oral, Other) data element as
standardized patient assessment data for
use in the SNF QRP.
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(2) Cancer Treatment: Radiation
We are proposing that the Radiation
data element meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21064 through
21065), radiation is a type of cancer
treatment that uses high-energy
radioactivity to stop cancer by damaging
cancer cell DNA, but it can also damage
normal cells. Radiation is an important
therapy for particular types of cancer,
and the resource utilization is high,
with frequent radiation sessions
required, often daily for a period of
several weeks. Assessing whether a
patient or resident is receiving radiation
therapy is important to determine
resource utilization because PAC
patients and residents will need to be
transported to and from radiation
treatments, and monitored and treated
for side effects after receiving this
intervention. Therefore, assessing the
receipt of radiation therapy, which
would compete with other care
processes given the time burden, would
be important for care planning and care
coordination by PAC providers.
The proposed data element consists of
the single Radiation data element. The
Radiation data element is currently in
use in the MDS in SNFs. For more
information on the Radiation data
element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Radiation data element was first
proposed as a SPADE in the FY 2018
SNF PPS proposed rule (82 FR 21064
through 21065). In that proposed rule,
we stated that the proposal was
informed by input we received through
a call for input published on the CMS
Measures Management System
Blueprint website. Input submitted from
August 12 to September 12, 2016,
expressed support for the Radiation data
element, noting its importance and
clinical usefulness for patients and
residents in PAC settings, due to the
side effects and consequences of
radiation treatment on patients and
residents that need to be considered in
care planning and care transitions, the
feasibility of the item, and the potential
for it to improve quality. A summary
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report for the August 12 to September
12, 2016 public comment period titled
‘‘SPADE August 2016 Public Comment
Summary Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
Radiation as a standardized patient
assessment data element.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the
Radiation data element was included in
the National Beta Test of candidate data
elements conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the Radiation data element to be feasible
and reliable for use with PAC patients
and residents. More information about
the performance of the Radiation data
element in the National Beta Test can be
found in the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP members
did not specifically discuss the
Radiation data element, the TEP
members supported the assessment of
the special services, treatments, and
interventions included in the National
Beta Test with respect to both admission
and discharge. A summary of the
September 17, 2018 TEP meeting titled
‘‘SPADE Technical Expert Panel
Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present results of the
National Beta Test and solicit additional
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comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for radiation, stakeholder
input, and strong test results, we are
proposing that the Radiation data
element meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and
to adopt the Radiation data element as
standardized patient assessment data for
use in the SNF QRP.
(3) Respiratory Treatment: Oxygen
Therapy (Intermittent, Continuous,
High-Concentration Oxygen Delivery
System)
We are proposing that the Oxygen
Therapy (Intermittent, Continuous,
High-Concentration Oxygen Delivery
System) data element meets the
definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21065), oxygen
therapy provides a patient or resident
with extra oxygen when medical
conditions such as chronic obstructive
pulmonary disease, pneumonia, or
severe asthma prevent the patient or
resident from getting enough oxygen
from breathing. Oxygen administration
is a resource-intensive intervention, as it
requires specialized equipment such as
a source of oxygen, delivery systems (for
example, oxygen concentrator, liquid
oxygen containers, and high-pressure
systems), the patient interface (for
example, nasal cannula or mask), and
other accessories (for example,
regulators, filters, tubing). The data
element proposed here captures patient
or resident use of three types of oxygen
therapy (intermittent, continuous, and
high-concentration oxygen delivery
system), which reflects the intensity of
care needed, including the level of
monitoring and bedside care required.
Assessing the receipt of this service is
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important for care planning and
resource use for PAC providers.
The proposed data element, Oxygen
Therapy, consists of the principal
Oxygen Therapy data element and three
response option sub-elements:
Continuous (whether the oxygen was
delivered continuously, typically
defined as >=14 hours per day);
Intermittent; or High-concentration
oxygen delivery system. Based on
public comments and input from expert
advisors about the importance and
clinical usefulness of documenting the
extent of oxygen use, we added a third
sub-element, high-concentration oxygen
delivery system, to the sub-elements,
which previously included only
intermittent and continuous. If the
assessor indicates that the resident is
receiving oxygen therapy on the
principal oxygen therapy data element,
the assessor then would indicate the
type of oxygen the patient receives (for
example, Continuous, Intermittent,
High-concentration oxygen delivery
system).
These three proposed sub-elements
were developed based on similar data
elements that assess oxygen therapy,
currently in use in the MDS in SNFs
(‘‘Oxygen Therapy’’), previously used in
the OASIS (‘‘Oxygen (intermittent or
continuous)’’), and a data element tested
in the PAC PRD that focused on
intensive oxygen therapy (‘‘High O2
Concentration Delivery System with
FiO2 >40 percent’’). For more
information on the proposed Oxygen
Therapy (Continuous, Intermittent,
High-concentration oxygen delivery
system) data element, we refer readers
to the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Oxygen Therapy (Continuous,
Intermittent) data element was first
proposed as standardized patient
assessment data in the FY 2018 SNF
PPS proposed rule (82 FR 21065). In
that proposed rule, we stated that the
proposal was informed by input we
received on the single data element,
Oxygen (inclusive of intermittent and
continuous oxygen use), through a call
for input published on the CMS
Measures Management System
Blueprint website. Input submitted from
August 12 to September 12, 2016
expressed the importance of the Oxygen
data element, noting feasibility of this
item in PAC, and the relevance of it to
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facilitating care coordination and
supporting care transitions, but
suggesting that the extent of oxygen use
be documented. A summary report for
the August 12 to September 12, 2016
public comment period titled ‘‘SPADE
August 2016 Public Comment Summary
Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, a few
commenters supported the adoption of
Oxygen Therapy (Continuous,
Intermittent) as a standardized patient
assessment data element. Another
commenter recommended that an
option for high-concentration oxygen be
added. In response to public comments,
we added a third sub-element for ‘‘HighConcentration Oxygen Delivery System’’
to the Oxygen Therapy data element.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the Oxygen
Therapy data element was included in
the National Beta Test of candidate data
elements conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the Oxygen Therapy data element to be
feasible and reliable for use with PAC
patients and residents. More
information about the performance of
the Oxygen Therapy data element in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Oxygen Therapy
data element, the TEP supported the
assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of-
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2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing oxygen therapy, stakeholder
input, and strong test results, we are
proposing that the Oxygen Therapy
(Continuous, Intermittent, Highconcentration Oxygen Delivery System)
data element with a principal data
element and three sub-elements meets
the definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Oxygen Therapy
(Continuous, Intermittent, Highconcentration Oxygen Delivery System)
data element as standardized patient
assessment data for use in the SNF QRP.
(4) Respiratory Treatment: Suctioning
(Scheduled, as Needed)
We are proposing that the Suctioning
(Scheduled, As needed) data element
meets the definition of standardized
patient assessment data with respect to
special services, treatments, and
interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21065 through
21066), suctioning is a process used to
clear secretions from the airway when a
person cannot clear those secretions on
his or her own. It is done by aspirating
secretions through a catheter connected
to a suction source. Types of suctioning
include oropharyngeal and
nasopharyngeal suctioning, nasotracheal
suctioning, and suctioning through an
artificial airway such as a tracheostomy
tube. Oropharyngeal and
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nasopharyngeal suctioning are a key
part of many patients’ care plans, both
to prevent the accumulation of
secretions than can lead to aspiration
pneumonias (a common condition in
patients and residents with inadequate
gag reflexes), and to relieve obstructions
from mucus plugging during an acute or
chronic respiratory infection, which
often lead to desaturations and
increased respiratory effort. Suctioning
can be done on a scheduled basis if the
patient is judged to clinically benefit
from regular interventions, or can be
done as needed when secretions become
so prominent that gurgling or choking is
noted, or a sudden desaturation occurs
from a mucus plug. As suctioning is
generally performed by a care provider
rather than independently, this
intervention can be quite resource
intensive if it occurs every hour, for
example, rather than once a shift. It also
signifies an underlying medical
condition that prevents the patient from
clearing his/her secretions effectively
(such as after a stroke, or during an
acute respiratory infection). Generally,
suctioning is necessary to ensure that
the airway is clear of secretions which
can inhibit successful oxygenation of
the individual. The intent of suctioning
is to maintain a patent airway, the loss
of which can lead to death or
complications associated with hypoxia.
The Suctioning (Scheduled, As
needed) data element consists of a
principal data element, and two subelements: Scheduled; and As needed.
These sub-elements capture two types of
suctioning. Scheduled indicates
suctioning based on a specific
frequency, such as every hour; As
needed means suctioning only when
indicated. If the assessor indicates that
the resident is receiving suctioning on
the principal Suctioning data element,
the assessor would then indicate the
frequency (for example, Scheduled, As
needed). The proposed data element is
based on an item currently in use in the
MDS in SNFs which does not include
our proposed two sub-elements, as well
as data elements tested in the PAC PRD
that focused on the frequency of
suctioning required for patients with
tracheostomies (‘‘Trach Tube with
Suctioning: Specify most intensive
frequency of suctioning during stay
[Every __hours]’’). We are proposing to
expand the existing Suctioning data
element on the MDS to include subelements for Scheduled and As Needed.
For more information on the Suctioning
data element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
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Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Suctioning data element was first
proposed as standardized patient
assessment data in the FY 2018 SNF
PPS proposed rule (82 FR 21065
through 21066). In that proposed rule,
we stated that the proposal was
informed by input we received on the
Suctioning data element currently
included in the MDS in SNFs through
a call for input published on the CMS
Measures Management System
Blueprint website. Input submitted from
August 12 to September 12, 2016
expressed support for this data element.
The input noted the feasibility of this
item in PAC, and the relevance of this
data element to facilitating care
coordination and supporting care
transitions. We also stated that those
commenters had suggested that we
examine the frequency of suctioning to
better understand the use of staff time,
the impact on a patient or resident’s
capacity to speak and swallow, and
intensity of care required. Based on
these comments, we decided to add two
sub-elements (Scheduled and As
needed) to the suctioning element. The
proposed Suctioning data element
includes both the principal Suctioning
data element that is included on the
MDS in SNFs and two sub-elements,
Scheduled and As needed. A summary
report for the August 12 to September
12, 2016 public comment period titled
‘‘SPADE August 2016 Public Comment
Summary Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
Suctioning (Scheduled, As needed) as a
standardized patient assessment data
element. One commenter objected to
‘‘scheduled’’ suctioning as a response
option due to a clinical practice
guideline recommendation that
suctioning should only be performed
when clinically indicated and not on a
scheduled basis.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the
Suctioning data element was included
in the National Beta Test of candidate
data elements conducted by our data
element contractor from November 2017
to August 2018. Results of this test
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found the Suctioning data element to be
feasible and reliable for use with PAC
patients and residents. More
information about the performance of
the Suctioning data element in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Suctioning data
element, the TEP supported the
assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicited
additional comments. General input on
the testing and item development
process and concerns about burden
were received from stakeholders during
this meeting and via email through
February 1, 2019. A summary of the
public input received from the
November 27, 2018 stakeholder meeting
titled ‘‘Input on Standardized Patient
Assessment Data Elements (SPADEs)
Received After November 27, 2018
Stakeholder Meeting’’ is available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for suctioning, stakeholder
input, and strong test results, we are
proposing that the Suctioning
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(Scheduled, As needed) data element
with a principal data element and two
sub-elements meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and
to adopt the Suctioning (Scheduled, As
needed) data element as standardized
patient assessment data for use in the
SNF QRP.
(5) Respiratory Treatment:
Tracheostomy Care
We are proposing that the
Tracheostomy Care data element meets
the definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21066 through
21067), a tracheostomy provides an air
passage to help a patient or resident
breathe when the usual route for
breathing is obstructed or impaired.
Generally, in all of these cases,
suctioning is necessary to ensure that
the tracheostomy is clear of secretions,
which can inhibit successful
oxygenation of the individual. Often,
individuals with tracheostomies are also
receiving supplemental oxygenation.
The presence of a tracheostomy, albeit
permanent or temporary, warrants
careful monitoring and immediate
intervention if the tracheostomy
becomes occluded or if the device used
becomes dislodged. While in rare cases
the presence of a tracheostomy is not
associated with increased care demands
(and in some of those instances, the care
of the ostomy is performed by the
patient) in general the presence of such
as device is associated with increased
patient risk, and clinical care services
will necessarily include close
monitoring to ensure that no lifethreatening events occur as a result of
the tracheostomy. In addition,
tracheostomy care, which primarily
consists of cleansing, dressing changes,
and replacement of the tracheostomy
cannula (tube), is a critical part of the
care plan. Regular cleansing is
important to prevent infection such as
pneumonia, and to prevent any
occlusions with which there are risks
for inadequate oxygenation.
The proposed data element consists of
the single Tracheostomy Care data
element. The proposed data element is
currently in use in the MDS in SNFs
(‘‘Tracheostomy care’’). For more
information on the Tracheostomy Care
data element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
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Federal Register / Vol. 84, No. 80 / Thursday, April 25, 2019 / Proposed Rules
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Tracheostomy Care data element
was first proposed as standardized
patient assessment data in the FY 2018
SNF PPS proposed rule (82 FR 21066
through 21067). In that proposed rule,
we stated that the proposal was
informed by input we received on the
Tracheostomy Care data element
through a call for input published on
the CMS Measures Management System
Blueprint website. Input submitted from
August 12 to September 12, 2016,
supported this data element, noting the
feasibility of this item in PAC, and the
relevance of this data element to
facilitating care coordination and
supporting care transitions. A summary
report for the August 12 to September
12, 2016 public comment period titled
‘‘SPADE August 2016 Public Comment
Summary Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, we
received a few comments in support of
the adoption of Tracheostomy Care as a
standardized patient assessment data
element.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the
Tracheostomy Care data element was
included in the National Beta Test of
candidate data elements conducted by
our data element contractor from
November 2017 to August 2018. Results
of this test found the Tracheostomy Care
data element to be feasible and reliable
for use with PAC patients and residents.
More information about the
performance of the Tracheostomy Care
data element in the National Beta Test
can be found in the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
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elements. Although the TEP did not
specifically discuss the Tracheostomy
Care data element, the TEP supported
the assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for tracheostomy care,
stakeholder input, and strong test
results, we are proposing that the
Tracheostomy Care data element meets
the definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Tracheostomy Care
data element as standardized patient
assessment data for use in the SNF QRP.
(6) Respiratory Treatment: Non-Invasive
Mechanical Ventilator (BiPAP, CPAP)
We are proposing that the Noninvasive Mechanical Ventilator (Bilevel
Positive Airway Pressure [BiPAP],
Continuous Positive Airway Pressure
[CPAP]) data element meets the
definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act.
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As described in the FY 2018 SNF PPS
proposed rule (82 FR 21067), BiPAP and
CPAP are respiratory support devices
that prevent the airways from closing by
delivering slightly pressurized air via
electronic cycling throughout the
breathing cycle (BiPAP) or through a
mask continuously (CPAP). Assessment
of non-invasive mechanical ventilation
is important in care planning, as both
CPAP and BiPAP are resource-intensive
(although less so than invasive
mechanical ventilation) and signify
underlying medical conditions about
the patient or resident who requires the
use of this intervention. Particularly
when used in settings of acute illness or
progressive respiratory decline,
additional staff (for example, respiratory
therapists) are required to monitor and
adjust the CPAP and BiPAP settings and
the patient or resident may require more
nursing resources.
The proposed data element, Noninvasive Mechanical Ventilator (BIPAP,
CPAP), consists of the principal Noninvasive Mechanical Ventilator data
element and two response option subelements: BiPAP and CPAP. If the
assessor indicates that the resident is
receiving non-invasive mechanical
ventilation on the principal Noninvasive Mechanical Ventilator data
element, the assessor would then
indicate which type (for example,
BIPAP, CPAP). Data elements that assess
non-invasive mechanical ventilation are
currently included on LCDS for the
LTCH setting (‘‘Non-invasive Ventilator
(BIPAP, CPAP)’’), and the MDS for the
SNF setting (‘‘Non-invasive Mechanical
Ventilator (BiPAP/CPAP)’’). We are
proposing to expand the existing
BiPAP/CPAP data element on the MDS,
retaining and relabeling the BiPAP/
CPAP data element to be Non-invasive
Mechanical Ventilator (BiPAP, CPAP),
and adding two sub-elements for BiPAP
and CPAP. For more information on the
Non-invasive Mechanical Ventilator
(BIPAP, CPAP) data element, we refer
readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
The Non-invasive Mechanical
Ventilator data element was first
proposed as standardized patient
assessment data elements in the FY
2018 SNF PPS proposed rule (82 FR
21067). In that proposed rule, we stated
that the proposal was informed by input
we received through a call for input
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published on the CMS Measures
Management System Blueprint website.
Input submitted from August 12 to
September 12, 2016 on a single data
element, BiPAP/CPAP, that captures
equivalent clinical information but uses
a different label than the data element
currently used in the MDS in SNFs and
LCDS in LTCHs, expressed support for
this data element, noting the feasibility
of these items in PAC, and the relevance
of this data element for facilitating care
coordination and supporting care
transitions. In addition, we also stated
that some commenters supported
separating out BiPAP and CPAP as
distinct sub-elements, as they are
therapies used for different types of
patients and residents. A summary
report for the August 12 to September
12, 2016 public comment period titled
‘‘SPADE August 2016 Public Comment
Summary Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
Non-Invasive Mechanical Ventilator
(BiPAP, CPAP) as a standardized patient
assessment data element.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the Noninvasive Mechanical Ventilator data
element was included in the National
Beta Test of candidate data elements
conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the Non-invasive Mechanical Ventilator
data element to be feasible and reliable
for use with PAC patients and residents.
More information about the
performance of the Non-invasive
Mechanical Ventilator data element in
the National Beta Test can be found in
the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018, for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Non-invasive
Mechanical Ventilator data element, the
TEP supported the assessment of the
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special services, treatments, and
interventions included in the National
Beta Test with respect to both admission
and discharge. A summary of the
September 17, 2018 TEP meeting titled
‘‘SPADE Technical Expert Panel
Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for non-invasive mechanical
ventilation, stakeholder input, and
strong test results, we are proposing that
the Non-invasive Mechanical Ventilator
(BiPAP, CPAP) data element with a
principal data element and two subelements meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and
to adopt the Non-invasive Mechanical
Ventilator (BiPAP, CPAP) data element
as standardized patient assessment data
for use in the SNF QRP.
(7) Respiratory Treatment: Invasive
Mechanical Ventilator
We are proposing that the Invasive
Mechanical Ventilator data element
meets the definition of standardized
patient assessment data with respect to
special services, treatments, and
interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21067 through
21068), invasive mechanical ventilation
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17655
includes ventilators and respirators that
ventilate the patient through a tube that
extends via the oral airway into the
pulmonary region or through a surgical
opening directly into the trachea. Thus,
assessment of invasive mechanical
ventilation is important in care planning
and risk mitigation. Ventilation in this
manner is a resource-intensive therapy
associated with life-threatening
conditions without which the patient or
resident would not survive. However,
ventilator use has inherent risks
requiring close monitoring. Failure to
adequately care for the patient or
resident who is ventilator dependent
can lead to iatrogenic events such as
death, pneumonia, and sepsis.
Mechanical ventilation further signifies
the complexity of the patient’s
underlying medical or surgical
condition. Of note, invasive mechanical
ventilation is associated with high daily
and aggregate costs.91
The proposed data element, Invasive
Mechanical Ventilator, consists of a
single data element. Data elements that
capture invasive mechanical ventilation
are currently in use in the MDS in SNFs
and LCDS in LTCHs. The MDS currently
assesses invasive mechanical ventilation
with the Ventilator or Respirator data
element. We are proposing to rename
this data element in the MDS to be
Invasive Mechanical Ventilator. For
more information on the Invasive
Mechanical Ventilator data element, we
refer readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
The Invasive Mechanical Ventilator
data element was first proposed as
standardized patient assessment data in
the FY 2018 SNF PPS proposed rule (82
FR 21067 through 21068). In that
proposed rule, we stated that the
proposal was informed by input we
received through a call for input
published on the CMS Measures
Management System Blueprint website
on data elements that assess invasive
ventilator use and weaning status that
were tested in the PAC PRD
(‘‘Ventilator—Weaning’’ and
‘‘Ventilator—Non-Weaning’’). Input
submitted from August 12 to September
12, 2016 expressed support for this data
91 Wunsch, H., Linde-Zwirble, W. T., Angus, D.
C., Hartman, M. E., Milbrandt, E. B., & Kahn, J. M.
(2010). ‘‘The epidemiology of mechanical
ventilation use in the United States.’’ Critical Care
Med 38(10): 1947–1953.
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element, highlighting the importance of
this information in supporting care
coordination and care transitions. We
also stated that some commenters had
expressed concern about the
appropriateness for standardization
given: The prevalence of ventilator
weaning across PAC providers; the
timing of administration; how weaning
is defined; and how weaning status in
particular relates to quality of care.
These public comments guided our
decision to propose a single data
element focused on current use of
invasive mechanical ventilation only,
which does not attempt to capture
weaning status. A summary report for
the August 12 to September 12, 2016
public comment period titled ‘‘SPADE
August 2016 Public Comment Summary
Report’’ we received is available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, a few
commenters supported the adoption of
Invasive Mechanical Ventilator as a
standardized patient assessment data
element. One commenter stated that a
data element to indicate ‘‘weaning’’ is
important because it indicates higher
resource utilization.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the Invasive
Mechanical Ventilator data element was
included in the National Beta Test of
candidate data elements conducted by
our data element contractor from
November 2017 to August 2018. Results
of this test found the Invasive
Mechanical Ventilator data element to
be feasible and reliable for use with PAC
patients and residents. More
information about the performance of
the Invasive Mechanical Ventilator data
element in the National Beta Test can be
found in the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018, for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Invasive
Mechanical Ventilator data element, the
TEP supported the assessment of the
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special services, treatments, and
interventions included in the National
Beta Test with respect to both admission
and discharge. A summary of the
September 17, 2018 TEP meeting titled
‘‘SPADE Technical Expert Panel
Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for invasive mechanical
ventilation, stakeholder input, and
strong test results, we are proposing that
the Invasive Mechanical Ventilator data
element that assesses the use of an
invasive mechanical ventilator meets
the definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Invasive
Mechanical Ventilator data element as
standardized patient assessment data for
use in the SNF QRP.
(8) Intravenous (IV) Medications
(Antibiotics, Anticoagulants, Vasoactive
Medications, Other)
We are proposing that the IV
Medications (Antibiotics,
Anticoagulants, Vasoactive Medications,
Other) data element meets the definition
of standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21068 through
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21069), when we proposed a similar
data element related to IV medications,
IV medications are solutions of a
specific medication (for example,
antibiotics, anticoagulants)
administered directly into the venous
circulation via a syringe or intravenous
catheter. IV medications are
administered via intravenous push,
single, intermittent, or continuous
infusion through a catheter placed into
the vein. Further, IV medications are
more resource intensive to administer
than oral medications, and signify a
higher patient complexity (and often
higher severity of illness).
The clinical indications for each of
the sub-elements of the IV Medications
data element (Antibiotics,
Anticoagulants, Vasoactive Medications,
and Other) are very different. IV
antibiotics are used for severe infections
when the bioavailability of the oral form
of the medication would be inadequate
to kill the pathogen or an oral form of
the medication does not exist. IV
anticoagulants refer to anti-clotting
medications (that is, ‘‘blood thinners’’).
IV anticoagulants are commonly used
for hospitalized patients who have deep
venous thrombosis, pulmonary
embolism, or myocardial infarction, as
well as those undergoing interventional
cardiac procedures. Vasoactive
medications refer to the IV
administration of vasoactive drugs,
including vasopressors, vasodilators,
and continuous medication for
pulmonary edema, which increase or
decrease blood pressure or heart rate.
The indications, risks, and benefits of
each of these classes of IV medications
are distinct, making it important to
assess each separately in PAC. Knowing
whether or not patients and residents
are receiving IV medication and the type
of medication provided by each PAC
provider will improve quality of care.
The IV Medications (Antibiotics,
Anticoagulants, Vasoactive Medications,
and Other) data element we are
proposing consists of a principal data
element (IV Medications) and four
response option sub-elements:
Antibiotics, Anticoagulants, Vasoactive
Medications, and Other. The Vasoactive
Medications sub-element was not
proposed in the FY 2018 SNF PPS
proposed rule. We added the Vasoactive
Medications sub-element to our
proposal in order to harmonize the
proposed IV Medications element with
the data currently collected in the
LCDS.
If the assessor indicates that the
resident is receiving IV medications on
the principal IV Medications data
element, the assessor would then
indicate which types of medications (for
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example, Antibiotics, Anticoagulants,
Vasoactive Medications, Other). An IV
Medications data element is currently in
use on the MDS in SNFs and there is a
related data element in OASIS that
collects information on Intravenous and
Infusion Therapies. We are proposing to
expand the existing IV Medications data
element in the MDS to include subelements for Antibiotics,
Anticoagulants, Vasoactive Medications,
and Other. For more information on the
IV Medications (Antibiotics,
Anticoagulants, Vasoactive Medications,
Other) data element, we refer readers to
the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
An IV Medications data element was
first proposed as SPADEs in the FY
2018 SNF PPS proposed rule (82 FR
21068 through 21069). In that proposed
rule, we stated that the proposal was
informed by input we received on
Vasoactive Medications through a call
for input published on the CMS
Measures Management System
Blueprint website. Input submitted from
August 12 to September 12, 2016
supported this data element with one
noting the importance of this data
element in supporting care transitions.
We also stated that those commenters
had criticized the need for collecting
specifically Vasoactive Medications,
giving feedback that the data element
was too narrowly focused. In addition,
public comment received indicated that
the clinical significance of vasoactive
medications administration alone was
not high enough in PAC to merit
mandated assessment, noting that
related and more useful information
could be captured in an item that
assessed all IV medication use. A
summary report for the August 12 to
September 12, 2016 public comment
period titled ‘‘SPADE August 2016
Public Comment Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
Intravenous (IV) Medications
(Antibiotics, Anticoagulation, Other) as
a standardized patient assessment data
element.
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Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the IV
Medications data element was included
in the National Beta Test of candidate
data elements conducted by our data
element contractor from November 2017
to August 2018. Results of this test
found the IV Medications data element
to be feasible and reliable for use with
PAC patients and residents. More
information about the performance of
the IV Medications data element in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the IV Medications
data element, the TEP supported the
assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
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IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for IV medications,
stakeholder input, and strong test
results, we are proposing that the IV
Medications (Antibiotics,
Anticoagulants, Vasoactive Medications,
Other) data element with a principal
data element and four sub-elements
meets the definition of standardized
patient assessment data with respect to
special services, treatments, and
interventions under section
1899B(b)(1)(B)(iii) of the Act and to
adopt the IV Medications (Antibiotics,
Anticoagulants, Vasoactive Medications,
Other) data element as standardized
patient assessment data for use in the
SNF QRP.
(9) Transfusions
We are proposing that the
Transfusions data element meets the
definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21069),
transfusion refers to introducing blood
or blood products into the circulatory
system of a person. Blood transfusions
are based on specific protocols, with
multiple safety checks and monitoring
required during and after the infusion in
case of adverse events. Coordination
with the provider’s blood bank is
necessary, as well as documentation by
clinical staff to ensure compliance with
regulatory requirements. In addition, the
need for transfusions signifies
underlying patient complexity that is
likely to require care coordination and
patient monitoring, and impacts
planning for transitions of care, as
transfusions are not performed by all
PAC providers.
The proposed data element consists of
the single Transfusions data element. A
data element on transfusion is currently
in use in the MDS in SNFs
(‘‘Transfusions’’) and a data element
tested in the PAC PRD (‘‘Blood
Transfusions’’) was found feasible for
use in each of the four PAC settings. For
more information on the Transfusions
data element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
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In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
Transfusions as a standardized patient
assessment data element.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the
Transfusions data element was included
in the National Beta Test of candidate
data elements conducted by our data
element contractor from November 2017
to August 2018. Results of this test
found the Transfusions data element to
be feasible and reliable for use with PAC
patients and residents. More
information about the performance of
the Transfusions data element in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018, for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Transfusions
data element, the TEP supported the
assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
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2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for transfusions, stakeholder
input, and strong test results, we are
proposing that the Transfusions data
element meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and
to adopt the Transfusions data element
as standardized patient assessment data
for use in the SNF QRP.
(10) Dialysis (Hemodialysis, Peritoneal
Dialysis)
We are proposing that the Dialysis
(Hemodialysis, Peritoneal dialysis) data
element meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21070), dialysis is
a treatment primarily used to provide
replacement for lost kidney function.
Both forms of dialysis (hemodialysis
and peritoneal dialysis) are resource
intensive, not only during the actual
dialysis process but before, during, and
following. Patients and residents who
need and undergo dialysis procedures
are at high risk for physiologic and
hemodynamic instability from fluid
shifts and electrolyte disturbances, as
well as infections that can lead to
sepsis. Further, patients or residents
receiving hemodialysis are often
transported to a different facility, or at
a minimum, to a different location in
the same facility for treatment. Close
monitoring for fluid shifts, blood
pressure abnormalities, and other
adverse effects is required prior to,
during, and following each dialysis
session. Nursing staff typically perform
peritoneal dialysis at the bedside, and as
with hemodialysis, close monitoring is
required.
The proposed data element, Dialysis
(Hemodialysis, Peritoneal dialysis)
consists of the principal Dialysis data
element and two response option subelements: Hemodialysis and Peritoneal
dialysis. If the assessor indicates that
the resident is receiving dialysis on the
principal Dialysis data element, the
assessor would then indicate which
type (Hemodialysis or Peritoneal
dialysis). Dialysis data elements are
currently included on the MDS in SNFs
and the LCDS in LTCHs and assess the
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overall use of dialysis. We are proposing
to expand the existing Dialysis data
element in the MDS to include subelements for Hemodialysis and
Peritoneal dialysis.
As the result of public feedback
described below, in this proposed rule,
we are proposing a data element that
includes the principal Dialysis data
element and two sub-elements
(Hemodialysis and Peritoneal dialysis).
For more information on the Dialysis
data elements, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Dialysis data element was first
proposed as standardized patient
assessment data in the FY 2018 SNF
PPS proposed rule (82 FR 21070). In
that proposed rule, we stated that the
proposal was informed by input we
received on a singular Hemodialysis
data element through a call for input
published on the CMS Measures
Management System Blueprint website.
Input submitted from August 12 to
September 12, 2016 supported the
assessment of hemodialysis and
recommended that the data element be
expanded to include peritoneal dialysis.
We also stated that those commenters
had supported the singular
Hemodialysis data element, noting the
relevance of this information for sharing
across the care continuum to facilitate
care coordination and care transitions,
the potential for this data element to be
used to improve quality, and the
feasibility for use in PAC. In addition,
we received comment that the item
would be useful in improving patient
and resident transitions of care. We also
noted that several commenters had
stated that peritoneal dialysis should be
included in a standardized data element
on dialysis and recommended collecting
information on peritoneal dialysis in
addition to hemodialysis. The rationale
for including peritoneal dialysis from
commenters included the fact that
patients and residents receiving
peritoneal dialysis will have different
needs at post-acute discharge compared
to those receiving hemodialysis or not
having any dialysis. Based on these
comments, the Hemodialysis data
element was expanded to include a
principal Dialysis data element and two
sub-elements, Hemodialysis and
Peritoneal dialysis. We are proposing
the version of the Dialysis element that
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includes two types of dialysis. A
summary report for the August 12 to
September 12, 2016 public comment
period titled ‘‘SPADE August 2016
Public Comment Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
Dialysis (Hemodialysis, Peritoneal
dialysis) as a standardized patient
assessment data element.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the Dialysis
data element was included in the
National Beta Test of candidate data
elements conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the Dialysis data element to be feasible
and reliable for use with PAC patients
and residents. More information about
the performance of the Dialysis data
element in the National Beta Test can be
found in the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018, for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although they did not
specifically discuss the Dialysis data
element, the TEP supported the
assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
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National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for dialysis, stakeholder input,
and strong test results, we are proposing
that the Dialysis (Hemodialysis,
Peritoneal dialysis) data element with a
principal data element and two subelements meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and
to adopt the Dialysis (Hemodialysis,
Peritoneal dialysis) data element as
standardized patient assessment data for
use in the SNF QRP.
(11) Intravenous (IV) Access (Peripheral
IV, Midline, Central line)
We are proposing that the IV Access
(Peripheral IV, Midline, Central line)
data element meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21070 through
21071), patients or residents with
central lines, including those
peripherally inserted or who have
subcutaneous central line ‘‘port’’ access,
always require vigilant nursing care to
keep patency of the lines and ensure
that such invasive lines remain free
from any potentially life-threatening
events such as infection, air embolism,
or bleeding from an open lumen.
Clinically complex patients and
residents are likely to be receiving
medications or nutrition intravenously.
The sub-elements included in the IV
Access data elements distinguish
between peripheral access and different
types of central access. The rationale for
distinguishing between a peripheral IV
and central IV access is that central
lines confer higher risks associated with
life-threatening events such as
pulmonary embolism, infection, and
bleeding.
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The proposed data element, IV Access
(Peripheral IV, Midline, Central line),
consists of the principal IV Access data
element and three response option subelements: Peripheral IV, Midline, and
Central line. The proposed IV Access
data element is not currently included
on any of the PAC assessment
instruments. For more information on
the IV Access (Peripheral IV, Midline,
Central line) data element, we refer
readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
The IV Access data element was first
proposed as standardized patient
assessment data in the FY 2018 SNF
PPS proposed rule (82 FR 21070
through 21071). In that proposed rule,
we stated that the proposal was
informed by input we received on one
of the PAC PRD data elements, Central
Line Management, a type of IV access,
through a call for input published on
the CMS Measures Management System
Blueprint website. Input submitted from
August 12 to September 12, 2016
supported the assessment of central line
management and recommended that the
data element be broadened to also
include other types of IV access. Several
commenters noted feasibility and
importance of facilitating care
coordination and care transitions.
However, a few commenters
recommended that the definition of this
data element be broadened to include
peripherally inserted central catheters
(‘‘PICC lines’’) and midline IVs. Based
on public comment feedback and in
consultation with expert input,
described below, we created an
overarching IV Access data element
with sub-elements for other types of IV
access in addition to central lines (that
is, peripheral IV and midline). This
expanded version of IV Access is the
data element being proposed. A
summary report for the August 12 to
September 12, 2016 public comment
period titled ‘‘SPADE August 2016
Public Comment Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
the IV Access (Peripheral IV, Midline,
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Central line, Other) as a standardized
patient assessment data element, with
one commenter encouraging clear
guidance in the Resident Assessment
Instrument User Manual to distinguish
between coding instructions for this
data element and those for other data
elements on IV treatments.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the IV
Access data element was included in
the National Beta Test of candidate data
elements conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the IV Access data element to be feasible
and reliable for use with PAC patients
and residents. More information about
the performance of the IV Access data
element in the National Beta Test can be
found in the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the IV Access data
element, the TEP supported the
assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
VerDate Sep<11>2014
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Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for IV access, stakeholder
input, and strong test results, we are
proposing that the IV access (Peripheral
IV, Midline, Central line) data element
with a principal data element and three
sub-elements meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and
to adopt the IV Access (Peripheral IV,
Midline, Central line) data element as
standardized patient assessment data for
use in the SNF QRP.
(12) Nutritional Approach: Parenteral/IV
Feeding
We are proposing that the Parenteral/
IV Feeding data element meets the
definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21071 through
21072), parenteral nutrition/IV feeding
refers to a patient or resident being fed
intravenously using an infusion pump,
bypassing the usual process of eating
and digestion. The need for IV/
parenteral feeding indicates a clinical
complexity that prevents the patient or
resident from meeting his or her
nutritional needs enterally, and is more
resource intensive than other forms of
nutrition, as it often requires monitoring
of blood chemistries and the
maintenance of a central line. Therefore,
assessing a patient’s or resident’s need
for parenteral feeding is important for
care planning and resource use. In
addition to the risks associated with
central and peripheral intravenous
access, total parenteral nutrition is
associated with significant risks such as
air embolism and sepsis.
The proposed data element consists of
the single Parenteral/IV Feeding data
element. The proposed Parenteral/IV
Feeding data element is currently in use
in the MDS in SNFs, and equivalent or
related data elements are in use in the
LCDS, IRF–PAI, and OASIS. For more
information on the Parenteral/IV
Feeding data element, we refer readers
to the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
PO 00000
Frm 00042
Fmt 4701
Sfmt 4702
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Parenteral/IV Feeding data
element was first proposed as a SPADE
in the FY 2018 SNF PPS proposed rule
(82 FR 21071 through 21072). In that
proposed rule, we stated that the
proposal was informed by input we
received on Total Parenteral Nutrition
(an item with nearly the same meaning
as the proposed data element, but with
the label used in the PAC PRD) through
a call for input published on the CMS
Measures Management System
Blueprint website. Input submitted from
August 12 to September 12, 2016
supported this data element, noting its
relevance to facilitating care
coordination and supporting care
transitions. After the public comment
period, the Total Parenteral Nutrition
data element was renamed Parenteral/IV
Feeding, to be consistent with how this
data element is referred to in the MDS
in SNFs. A summary report for the
August 12 to September 12, 2016 public
comment period titled ‘‘SPADE August
2016 Public Comment Summary
Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
the Parenteral/IV Feeding as a
standardized patient assessment data
element, with one requesting
‘‘universal’’ guidance for coding, which
would be clearly defined and more
broadly applicable to patients and
residents in all PAC settings.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the
Parenteral/IV Feeding data element was
included in the National Beta Test of
candidate data elements conducted by
our data element contractor from
November 2017 to August 2018. Results
of this test found the Parenteral/IV
Feeding data element to be feasible and
reliable for use with PAC patients and
residents. More information about the
performance of the Parenteral/IV
Feeding data element in the National
Beta Test can be found in the document
titled ‘‘Proposed Specifications for SNF
QRP Quality Measures and
Standardized Patient Assessment Data
Elements,’’ available at https://
www.cms.gov/Medicare/Quality-
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Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018, for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Parenteral/IV
Feeding data element, the TEP
supported the assessment of the special
services, treatments, and interventions
included in the National Beta Test with
respect to both admission and
discharge. A summary of the September
17, 2018 TEP meeting titled ‘‘SPADE
Technical Expert Panel Summary (Third
Convening)’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for parenteral/IV feeding,
stakeholder input, and strong test
results, we are proposing that the
Parenteral/IV Feeding data element
meets the definition of standardized
patient assessment data with respect to
special services, treatments, and
interventions under section
1899B(b)(1)(B)(iii) of the Act and to
adopt the Parenteral/IV Feeding data
element as standardized patient
assessment data for use in the SNF QRP.
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(13) Nutritional Approach: Feeding
Tube
We are proposing that the Feeding
Tube data element meets the definition
of standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21072), the
majority of patients admitted to acute
care hospitals experience deterioration
of their nutritional status during their
hospital stay, making assessment of
nutritional status and method of feeding
if unable to eat orally very important in
PAC. A feeding tube can be inserted
through the nose or the skin on the
abdomen to deliver liquid nutrition into
the stomach or small intestine. Feeding
tubes are resource intensive and,
therefore, are important to assess for
care planning and resource use. Patients
with severe malnutrition are at higher
risk for a variety of complications.92 In
PAC settings, there are a variety of
reasons that patients and residents may
not be able to eat orally (including
clinical or cognitive status).
The proposed data element consists of
the single Feeding Tube data element.
The Feeding Tube data element is
currently included in the MDS for SNFs,
and in the OASIS for HHAs, where it is
labeled Enteral Nutrition. A related data
element, collected in the IRF–PAI for
IRFs (‘‘Tube/Parenteral Feeding’’),
assesses use of both feeding tubes and
parenteral nutrition. For more
information on the Feeding Tube data
element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Feeding Tube data element was
first proposed as a SPADE in the FY
2018 SNF PPS proposed rule (82 FR
21072). In that proposed rule, we stated
that the proposal was informed by input
we received through a call for input
published on the CMS Measures
Management System Blueprint website.
Input submitted from August 12 to
September 12, 2016 on an Enteral
Nutrition data element (the Enteral
Nutrition data item is the same as the
92 Dempsey, D.T., Mullen, J.L., & Buzby, G.P.
(1988). ‘‘The link between nutritional status and
clinical outcome: can nutritional intervention
modify it?’’ Am J of Clinical Nutrition, 47(2): 352–
356.
PO 00000
Frm 00043
Fmt 4701
Sfmt 4702
17661
data element we are proposing in this
proposed rule, but is used in the OASIS
under a different name) supported the
data element, noting the importance of
assessing enteral nutrition status for
facilitating care coordination and care
transitions. After the public comment
period, the Enteral Nutrition data
element used in public comment was
renamed Feeding Tube, indicating the
presence of an assistive device. A
summary report for the August 12 to
September 12, 2016 public comment
period titled ‘‘SPADE August 2016
Public Comment Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
the Feeding Tube as a standardized
patient assessment data element.
Another commenter recommended that
the term ‘‘enteral feeding’’ be used
instead of ‘‘feeding tube.’’
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the Feeding
Tube data element was included in the
National Beta Test of candidate data
elements conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the Feeding Tube data element to be
feasible and reliable for use with PAC
patients and residents. More
information about the performance of
the Feeding Tube data element in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Feeding Tube
data element, the TEP supported the
assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-
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Assessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for feeding tubes, stakeholder
input, and strong test results, we are
proposing that the Feeding Tube data
element meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and
to adopt the Feeding Tube data element
as standardized patient assessment data
for use in the SNF QRP.
khammond on DSKBBV9HB2PROD with PROPOSALS3
(14) Nutritional Approach:
Mechanically Altered Diet
We are proposing that the
Mechanically Altered Diet data element
meets the definition of standardized
patient assessment data with respect to
special services, treatments, and
interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21072 through
21073), the Mechanically Altered Diet
data element refers to food that has been
altered to make it easier for the patient
or resident to chew and swallow, and
this type of diet is used for patients and
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residents who have difficulty
performing these functions. Patients
with severe malnutrition are at higher
risk for a variety of complications.93
In PAC settings, there are a variety of
reasons that patients and residents may
have impairments related to oral
feedings, including clinical or cognitive
status. The provision of a mechanically
altered diet may be resource intensive,
and can signal difficulties associated
with swallowing/eating safety,
including dysphagia. In other cases, it
signifies the type of altered food source,
such as ground or puree that will enable
the safe and thorough ingestion of
nutritional substances and ensure safe
and adequate delivery of nourishment to
the patient. Often, patients and
residents on mechanically altered diets
also require additional nursing
supports, such as individual feeding or
direct observation, to ensure the safe
consumption of the food product.
Assessing whether a patient or resident
requires a mechanically altered diet is
therefore important for care planning
and resource identification.
The proposed data element consists of
the single Mechanically Altered Diet
data element. The proposed data
element is currently included on the
MDS for SNFs. A related data element
(‘‘Modified food consistency/
supervision’’) is currently included on
the IRF–PAI for IRFs. Another related
data element is included in the OASIS
for HHAs that collects information
about independent eating that requires
‘‘a liquid, pureed or ground meat diet.’’
For more information on the
Mechanically Altered Diet data element,
we refer readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
The Mechanically Altered Diet data
element was first proposed as
standardized patient assessment data in
93 Dempsey, D.T., Mullen, J.L., & Buzby, G.P.
(1988). ‘‘The link between nutritional status and
clinical outcome: can nutritional intervention
modify it?’’ Am J of Clinical Nutrition, 47(2): 352–
356.
PO 00000
Frm 00044
Fmt 4701
Sfmt 4702
the FY 2018 SNF PPS proposed rule (82
FR 21072 through 21073).
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported the adoption of
the Mechanically Altered Diet as a
standardized patient assessment data
element, with one requesting
‘‘universal’’ guidance for coding, which
would be clearly defined and more
broadly applicable to patients and
residents in all PAC settings.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the
Mechanically Altered Diet data element
was included in the National Beta Test
of candidate data elements conducted
by our data element contractor from
November 2017 to August 2018. Results
of this test found the Mechanically
Altered Diet data element to be feasible
and reliable for use with PAC patients
and residents. More information about
the performance of the Mechanically
Altered Diet data element in the
National Beta Test can be found in the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018, for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Mechanically
Altered Diet data element, the TEP
supported the assessment of the special
services, treatments, and interventions
included in the National Beta Test with
respect to both admission and
discharge. A summary of the September
17, 2018 TEP meeting titled ‘‘SPADE
Technical Expert Panel Summary (Third
Convening)’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
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khammond on DSKBBV9HB2PROD with PROPOSALS3
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for mechanically altered diet,
stakeholder input, and strong test
results, we are proposing that the
Mechanically Altered Diet data element
meets the definition of standardized
patient assessment data with respect to
special services, treatments, and
interventions under section
1899B(b)(1)(B)(iii) of the Act and to
adopt the Mechanically Altered Diet
data element as standardized patient
assessment data for use in the SNF QRP.
(15) Nutritional Approach: Therapeutic
Diet
We are proposing that the Therapeutic
Diet data element meets the definition
of standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21073), a
therapeutic diet refers to meals planned
to increase, decrease, or eliminate
specific foods or nutrients in a patient’s
or resident’s diet, such as a low-salt
diet, for the purpose of treating a
medical condition. The use of
therapeutic diets among patients and
residents in PAC provides insight on the
clinical complexity of these patients and
residents and their multiple
comorbidities. Therapeutic diets are less
resource intensive from the bedside
nursing perspective, but do signify one
or more underlying clinical conditions
that preclude the patient from eating a
regular diet. The communication among
PAC providers about whether a patient
is receiving a particular therapeutic diet
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is critical to ensure safe transitions of
care.
The proposed data element consists of
the single Therapeutic Diet data
element. This data element is currently
in use in the MDS in SNFs. For more
information on the Therapeutic Diet
data element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Therapeutic Diet data element
was first proposed as standardized
patient assessment data in the FY 2018
SNF PPS proposed rule (82 FR 21073).
In response to our proposal in the FY
2018 SNF PPS proposed rule,
commenters supported the adoption of
the Therapeutic Diet as a standardized
patient assessment data element. Two
commenters stated that the coding
instructions should be clear and more
broadly applicable to patients and
residents in all PAC settings. Another
two commenters suggested that the
definition of Therapeutic Diet should be
aligned with the Academy of Nutrition
and Dietetics’ definition, with one
stating that ‘‘medically altered diet’’
should be added to the nutritional data
elements.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the
Therapeutic Diet data element was
included in the National Beta Test of
candidate data elements conducted by
our data element contractor from
November 2017 to August 2018. Results
of this test found the Therapeutic Diet
data element to be feasible and reliable
for use with PAC patients and residents.
More information about the
performance of the Therapeutic Diet
data element in the National Beta Test
can be found in the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018, for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. Although the TEP did not
specifically discuss the Therapeutic Diet
data element, the TEP supported the
PO 00000
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17663
assessment of the special services,
treatments, and interventions included
in the National Beta Test with respect to
both admission and discharge. A
summary of the September 17, 2018 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
A summary of the public input received
from the November 27, 2018 stakeholder
meeting titled ‘‘Input on Standardized
Patient Assessment Data Elements
(SPADEs) Received After November 27,
2018 Stakeholder Meeting’’ is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for therapeutic diet,
stakeholder input, and strong test
results, we are proposing that the
Therapeutic Diet data element meets the
definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Therapeutic data
element as standardized patient
assessment data for use in the SNF QRP.
(16) High Risk Drug Classes: Use and
Indication
We are proposing that the High-Risk
Drug Classes: Use and Indication data
element meets the definition of
standardized patient assessment data
with respect to special services,
treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
Most patients and residents receiving
PAC services depend on short- and
long-term medications to manage their
medical conditions. However, as a
treatment, medications are not without
risk; medications are in fact a leading
cause of adverse events. A study by the
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U.S. Department of Health and Human
Services found that 31 percent of
adverse events that occurred in 2008
among hospitalized Medicare
beneficiaries were related to
medication.94 Moreover, changes in a
patient’s condition, medications, and
transitions between care settings put
patients and residents at risk of
medication errors and adverse drug
events (ADEs). ADEs may be caused by
medication errors such as drug
omissions, errors in dosage, and errors
in dosing frequency.95
ADEs are known to occur across
different types of healthcare settings.
For example, the incidence of ADEs in
the outpatient setting has been
estimated at 1.15 ADEs per 100 personmonths,96 while the rate of ADEs in the
long-term care setting is approximately
9.80 ADEs per 100 resident-months.97 In
the hospital setting, the incidence has
been estimated at 15 ADEs per 100
admissions.98 In addition,
approximately half of all hospitalrelated medication errors and 20 percent
of ADEs occur during transitions within,
admission to, transfer to, or discharge
from a hospital.99 100 101 ADEs are more
common among older adults, who make
up most patients receiving PAC
services. The rate of emergency
department visits for ADEs is three
times higher among adults 65 years of
age and older compared to that among
those younger than age 65.102
Understanding the types of
medication a patient is taking and the
reason for its use are key facets of a
patient’s treatment with respect to
medication. Some classes of drugs are
associated with more risk than
others.103 We are proposing one HighRisk Drug Class data element with six
sub-elements. The six medication
classes response options are:
anticoagulants; antiplatelets;
hypoglycemics (including insulin);
opioids; antipsychotics; and antibiotics.
These drug classes are high-risk due to
the adverse effects that may result from
use. In particular: bleeding risk is
associated with anticoagulants and
antiplatelets; 104 105 fluid retention, heart
failure, and lactic acidosis are
associated with hypoglycemics; 106
misuse is associated with opioids; 107
fractures and strokes are associated with
antipsychotics; 108 109 and various
adverse events, such as central nervous
systems effects and gastrointestinal
intolerance, are associated with
antimicrobials,110 the larger category of
medications that include antibiotics.
Moreover, some medications in five of
the six drug classes included in this
data element are included in the 2019
Updated Beers Criteria® list as
potentially inappropriate medications
for use in older adults.111 Finally,
94 U.S. Department of Health and Human
Services. Office of Inspector General. Daniel R.
Levinson. Adverse Events in Hospitals: National
Incidence Among Medicare Beneficiaries. OEI–06–
09–00090. November 2010.
95 Boockvar K.S., Liu S., Goldstein N., Nebeker J.,
Siu A., Fried T. Prescribing discrepancies likely to
cause adverse drug events after patient transfer.
Qual Saf Health Care. 2009;18(1):32–6.
96 Gandhi T.K., Seger A.C., Overhage J.M., et al.
Outpatient adverse drug events identified by
screening electronic health records. J Patient Saf
2010;6:91–6.doi:10.1097/PTS.0b013e3181dcae06.
97 Gurwitz J.H., Field T.S., Judge J., Rochon P.,
Harrold L.R., Cadoret C., et al. The incidence of
adverse drug events in two large academic longterm care facilities. Am J Med. 2005; 118(3):251±8.
Epub 2005/03/05. https://doi.org/10.1016/
j.amjmed.2004.09.018 PMID: 15745723.
98 Hug B.L., Witkowski D.J., Sox C.M., Keohane
C.A., Seger D.L., Yoon C., Matheny M.E., Bates
D.W.. Occurrence of adverse, often preventable,
events in community hospitals involving
nephrotoxic drugs or those excreted by the kidney.
Kidney Int. 2009; 76:1192–1198. [PubMed:
19759525].
99 Barnsteiner J.H. Medication reconciliation:
transfer of medication information across settingskeeping it free from error. J Infus Nurs. 2005;28(2
Suppl):31–36.
100 Rozich J., Roger, R. Medication safety: one
organization’s approach to the challenge. Journal of
Clinical Outcomes Management. 2001(8):27–34.
101 Gleason K.M., Groszek J.M., Sullivan C.,
Rooney D., Barnard C., Noskin G.A. Reconciliation
of discrepancies in medication histories and
admission orders of newly hospitalized patients.
Am J Health Syst Pharm. 2004;61(16):1689–1695.
102 Shehab N., Lovegrove M.C., Geller A.I., Rose
K.O., Weidle N.J., Budnitz D.S. US emergency
department visits for outpatient adverse drug
events, 2013–2014. JAMA. doi: 10.1001/
jama.2016.16201.
103 Ibid.
104 Shoeb M., Fang M.C. Assessing bleeding risk
in patients taking anticoagulants. J Thromb
Thrombolysis. 2013;35(3):312–319. doi: 10.1007/
s11239–013–0899–7.
105 Melkonian M., Jarzebowski W., Pautas E.
Bleeding risk of antiplatelet drugs compared with
oral anticoagulants in older patients with atrial
fibrillation: a systematic review and meta-analysis.
J Thromb Haemost. 2017;15:1500–1510. DOI:
10.1111/jth.13697.
106 Hamnvik O.P., McMahon G.T. Balancing Risk
and Benefit with Oral Hypoglycemic Drugs. The
Mount Sinai journal of medicine, New York. 2009;
76:234–243.
107 Naples J.G., Gellad W.F., Hanlon J.T. The Role
of Opioid Analgesics in Geriatric Pain Management.
Clin Geriatr Med. 2016;32 (4):725–735.
108 Rigler S.K., Shireman T.I., Cook-Wiens G.J.,
Ellerbeck E.F., Whittle J.C., Mehr D.R., Mahnken
J.D. Fracture risk in nursing home residents
initiating antipsychotic medications. J Am Geriatr
Soc. 2013; 61(5):715–722. [PubMed: 23590366].
109 Wang S., Linkletter C., Dore D. et al. Age,
antipsychotics, and the risk of ischemic stroke in
the Veterans Health Administration. Stroke
2012;43:28–31. doi:10.1161/
STROKEAHA.111.617191.
110 Faulkner C.M., Cox H.L., Williamson J.C.
Unique aspects of antimicrobial use in older adults.
Clin Infect Dis. 2005;40(7):997–1004.
111 American Geriatrics Society 2019 Beers
Criteria Update Expert Panel. American Geriatrics
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although a complete medication list
should record several important
attributes of each medication (for
example, dosage, route, stop date),
recording an indication for the drug is
of crucial importance.112
The High-Risk Drug Classes: Use and
Indication data element requires an
assessor to record whether or not a
resident is taking any medications
within the six drug classes. The six
response options for this data element
are high-risk drug classes with
particular relevance to PAC patients and
residents, as identified by our data
element contractor. The six response
options are Anticoagulants,
Antiplatelets, Hypoglycemics, Opioids,
Antipsychotics, and Antibiotics. For
each drug class, the assessor is asked to
indicate if the resident is taking any
medications within the class, and, for
drug classes in which medications were
being taken, whether indications for all
drugs in the class are noted in the
medical record. For example, for the
response option Anticoagulants, if the
assessor indicates that the resident is
taking anticoagulant medication, the
assessor would then indicate if an
indication is recorded in the medication
record for the anticoagulant(s).
The High-Risk Drug Classes: Use and
Indication data element that is being
proposed as a SPADE was developed as
part of a larger set of data elements to
assess medication reconciliation, the
process of obtaining a patient’s multiple
medication lists and reconciling any
discrepancies. Similar data elements on
some high-risk medications are already
included in the MDS. We are proposing
to modify and expand existing data
elements in the MDS to include
additional high-risk drug classes and
indications for all drug classes. For
more information on the High-Risk Drug
Classes: Use and Indication data
element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Society 2019 Updated Beers Criteria for Potentially
Inappropriate Medication Use in Older Adults. J
Am Geriatr Soc 2019; 00:1–21. DOI: 10.1111/
jgs.15767.
112 Li Y., Salmasian H., Harpaz R., Chase H.,
Friedman C. Determining the reasons for
medication prescriptions in the EHR using
knowledge and natural language processing. AMIA
Annu Symp Proc. 2011;2011: 768–76.
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We sought public input on the
relevance of conducting assessments on
medication reconciliation and
specifically on the proposed High-Risk
Drug Classes: Use and Indication data
element. Our data element contractor
presented data elements related to
medication reconciliation to the TEP
convened on April 6 and 7, 2016. The
TEP supported a focus on high-risk
drugs, because of higher potential for
harm to patients and residents, and
were in favor of a data element to
capture whether or not indications for
medications were recorded in the
medical record. A summary of the April
6 and 7, 2016 TEP meeting titled
‘‘SPADE Technical Expert Panel
Summary (First Convening)’’ is
available at: https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html. Medication reconciliation
data elements were also discussed at a
second TEP meeting on January 5 and
6, 2017, convened by our data element
contractor. At this meeting, the TEP
agreed about the importance of
evaluating the medication reconciliation
process, but disagreed about how this
could be accomplished through
standardized assessment. The TEP also
disagreed about the usability and
appropriateness of using the Beers
Criteria to identify high-risk
medications.113 A summary of the
January 5 and 6, 2017 TEP meeting
titled ‘‘SPADE Technical Expert Panel
Summary (Second Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also solicited public input on data
elements related to medication
reconciliation during a public input
period from April 26 to June 26, 2017.
Several commenters expressed support
for the medication reconciliation data
elements that were put on display,
noting the importance of medication
reconciliation in preventing medication
errors and stated that the items seemed
feasible and clinically useful. A few
commenters were critical of the choice
of 10 drug classes posted during that
comment period, arguing that ADEs are
not limited to high-risk drugs, and
raised issues related to training
113 American Geriatrics Society 2015 Beers
Criteria Update Expert Panel. American Geriatrics
Society. Updated Beers Criteria for Potentially
Inappropriate Medication Use in Older Adults. J
Am Geriatr Soc 2015; 63:2227–2246.
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assessors to correctly complete a valid
assessment of medication reconciliation.
A summary report for the April 26 to
June 26, 2017 public comment period
titled ‘‘SPADE May–June 2017 Public
Comment Summary Report’’ is available
at: https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The High-Risk Drug Classes: Use and
Indication data element was included in
the National Beta Test of candidate data
elements conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the High-Risk Drug Classes: Use and
Indication data element to be feasible
and reliable for use with PAC patients
and residents. More information about
the performance of the High-Risk Drug
Classes: Use and Indication data
element in the National Beta Test can be
found in the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the proposed
standardized patient assessment data
elements. The TEP acknowledged the
challenges of assessing medication
safety, but were supportive of some of
the data elements focused on
medication reconciliation that were
tested in the National Beta Test. The
TEP was especially supportive of the
focus on the six high-risk drug classes
and using these classes to assess
whether the indication for a drug is
recorded. A summary of the September
17, 2018 TEP meeting titled ‘‘SPADE
Technical Expert Panel Summary (Third
Convening)’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. These
activities provided updates on the fieldtesting work and solicited feedback on
data elements considered for
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17665
standardization, including the HighRisk Drug Classes: Use and Indication
data element. One stakeholder group
was critical of the six drug classes
included as response options in the
High-Risk Drug Classes: Use and
Indication data element, noting that
potentially risky medications (for
example, muscle relaxants) are not
included in this list; that there may be
important differences between drugs
within classes (for example, more recent
versus older style antidepressants); and
that drug allergy information is not
captured. Finally, on November 27,
2018, our data element contractor
hosted a public meeting of stakeholders
to present the results of the National
Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
Additionally, one commenter
questioned whether the time to
complete this SPADE would differ
across settings. A summary of the public
input received from the November 27,
2018 stakeholder meeting titled ‘‘Input
on Standardized Patient Assessment
Data Elements (SPADEs) Received After
November 27, 2018 Stakeholder
Meeting’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing high-risk drugs and for
whether or not indications are noted for
high-risk drugs, stakeholder input, and
strong test results, we are proposing that
the High-Risk Drug Classes: Use and
Indication data element meets the
definition of standardized patient
assessment data with respect to special
services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the High-Risk Drug
Classes: Use and Indication data
element as standardized patient
assessment data for use in the SNF QRP.
d. Medical Condition and Comorbidity
Data
Assessing medical conditions and
comorbidities is critically important for
care planning and safety for patients
and residents receiving PAC services,
and the standardized assessment of
selected medical conditions and
comorbidities across PAC providers is
important for managing care transitions
and understanding medical complexity.
Below we discuss our proposals for
data elements related to the medical
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condition of pain as standardized
patient assessment data. Appropriate
pain management begins with a
standardized assessment, and thereafter
establishing and implementing an
overall plan of care that is personcentered, multi-modal, and includes the
treatment team and the patient.
Assessing and documenting the effect of
pain on sleep, participation in therapy,
and other activities may provide
information on undiagnosed conditions
and comorbidities and the level of care
required, and do so more objectively
than subjective numerical scores. With
that, we assess that taken separately and
together, these proposed data elements
are essential for care planning,
consistency across transitions of care,
and identifying medical complexities
including undiagnosed conditions. We
also conclude that it is the standard of
care to always consider the risks and
benefits associated with a personalized
care plan, including the risks of any
pharmacological therapy, especially
opioids.114 We also conclude that in
addition to assessing and appropriately
treating pain through the optimum mix
of pharmacologic, non-pharmacologic,
and alternative therapies, while being
cognizant of current prescribing
guidelines, clinicians in partnership
with patients are best able to mitigate
factors that contribute to the current
opioid crisis.115 116 117
In alignment with our Meaningful
Measures Initiative, accurate assessment
of medical conditions and comorbidities
of patients and residents in PAC is
expected to make care safer by reducing
harm caused in the delivery of care;
promote effective prevention and
treatment of chronic disease; strengthen
person and family engagement as
partners in their care; and promote
114 Department of Health and Human Services:
Pain Management Best Practices Inter-Agency Task
Force. Draft Report on Pain Management Best
Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://
www.hhs.gov/sites/default/files/final-pmtf-draftreport-on-pain-management%20-best-practices2018-12-12-html-ready-clean.pdf.
115 . Department of Health and Human Services:
Pain Management Best Practices Inter-Agency Task
Force. Draft Report on Pain Management Best
Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://
www.hhs.gov/sites/default/files/final-pmtf-draftreport-on-pain-management%20-best-practices2018-12-12-html-ready-clean.pdf.
116 Fishman S.M., Carr D.B., Hogans B., et al.
Scope and Nature of Pain- and Analgesia-Related
Content of the United States Medical Licensing
Examination (USMLE). Pain Med Malden Mass.
2018;19(3):449–459. doi:10.1093/pm/pnx336.
117 Fishman S.M., Young H.M., Lucas Arwood E.,
et al. Core competencies for pain management:
results of an interprofessional consensus summit.
Pain Med Malden Mass. 2013;14(7):971–981.
doi:10.1111/pme.12107.
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effective communication and
coordination of care. The SPADEs will
enable or support: Clinical decisionmaking and early clinical intervention;
person-centered, high quality care
through: facilitating better care
continuity and coordination; better data
exchange and interoperability between
settings; and longitudinal outcome
analysis. Therefore, reliable data
elements assessing medical conditions
and comorbidities are needed in order
to initiate a management program that
can optimize a patient’s or resident’s
prognosis and reduce the possibility of
adverse events.
We are inviting comment that apply
specifically to the standardized patient
assessment data for the category of
medical conditions and co-morbidities,
specifically on:
(1) Pain Interference (Pain Effect on
Sleep, Pain Interference With Therapy
Activities, and Pain Interference With
Day-to-Day Activities)
In acknowledgement of the opioid
crisis, we specifically are seeking
comment on whether or not we should
add these pain items in light of those
concerns. Commenters should address
to what extent collection of the data
below through patient queries might
encourage providers to prescribe
opioids.
We are proposing that a set of three
data elements on the topic of Pain
Interference (Pain Effect on Sleep, Pain
Interference with Therapy Activities,
and Pain Interference with Day-to-Day
Activities) meet the definition of
standardized patient assessment data
with respect to medical condition and
comorbidity data under section
1899B(b)(1)(B)(iv) of the Act.
The practice of pain management
began to undergo significant changes in
the 1990s because the inadequate, nonstandardized, non-evidence-based
assessment and treatment of pain
became a public health issue.118 In pain
management, a critical part of providing
comprehensive care is performance of a
thorough initial evaluation, including
assessment of both the medical and any
biopsychosocial factors causing or
contributing to the pain, with a
treatment plan to address the causes of
pain and to manage pain that persists
over time.119 Quality pain management,
118 Institute of Medicine. Relieving Pain in
America: A Blueprint for Transforming Prevention,
Care, Education, and Research. Washington (DC):
National Academies Press (US); 2011. https://
www.ncbi.nlm.nih.gov/books/NBK91497/.
119 Department of Health and Human Services:
Pain Management Best Practices Inter-Agency Task
Force. Draft Report on Pain Management Best
Practices: Updates, Gaps, Inconsistencies, and
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based on current guidelines and
evidence-based practices, can minimize
unnecessary opioid prescribing both by
offering alternatives or supplemental
treatment to opioids and by clearly
stating when they may be appropriate,
and how to utilize risk-benefit analysis
for opioid and non-opioid treatment
modalities.120 Pain is not a surprising
symptom in PAC patients and residents,
where healing, recovery, and
rehabilitation often require regaining
mobility and other functions after an
acute event. Standardized assessment of
pain that interferes with function is an
important first step towards appropriate
pain management in PAC settings. The
National Pain Strategy called for refined
assessment items on the topic of pain,
and describes the need for these
improved measures to be implemented
in PAC assessments.121 Further, the
focus on pain interference, as opposed
to pain intensity or pain frequency, was
supported by the TEP convened by our
data element contractor as an
appropriate and actionable metric for
assessing pain. A summary of the
September 17, 2018 TEP meeting titled
‘‘SPADE Technical Expert Panel
Summary (Third Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We appreciate the important concerns
related to the misuse and overuse of
opioids in the treatment of pain and to
that end we note that in this proposed
rule we have also proposed a SPADE
that assess for the use of, as well as
importantly the indication for that use
of, high risk drugs, including opioids.
Further, in the FY 2017 SNF PPS final
rule (81 FR 52039) we adopted the Drug
Regimen Review Conducted With
Follow-Up for Identified Issues—Post
Acute Care (PAC) SNF QRP measure
which assesses whether PAC providers
were responsive to potential or actual
clinically significant medication
issue(s), which includes issues
associated with use and misuse of
opioids for pain management, when
such issues were identified.
Recommendations. Accessed April 1, 2019. https://
www.hhs.gov/sites/default/files/final-pmtf-draftreport-on-pain-management%20-best-practices2018-12-12-html-ready-clean.pdf.
120 National Academies. Pain Management and
the Opioid Epidemic: Balancing Societal and
Individual Benefits and Risks of Prescription Opioid
Use. Washington DC: National Academies of
Sciences, Engineering, and Medicine.; 2017.
121 National Pain Strategy: A Comprehensive
Population-Health Level Strategy for Pain. https://
iprcc.nih.gov/sites/default/files/HHSNational_
Pain_Strategy_508C.pdf.
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We also note that the proposed
SPADE related to pain assessment are
not associated with any particular
approach to management. Since the use
of opioids is associated with serious
complications, particularly in the
elderly,122 123 124 an array of successful
non-pharmacologic and non-opioid
approaches to pain management may be
considered PAC providers have
historically used a range of pain
management strategies, including nonsteroidal anti-inflammatory drugs, ice,
transcutaneous electrical nerve
stimulation (TENS) therapy, supportive
devices, acupuncture, and the like. In
addition, non-pharmacological
interventions for pain management
include, but are not limited to,
biofeedback, application of heat/cold,
massage, physical therapy, nerve block,
stretching and strengthening exercises,
chiropractic, electrical stimulation,
radiotherapy, and ultrasound.125 126 127
We believe that standardized
assessment of pain interference will
support PAC clinicians in applying bestpractices in pain management for
chronic and acute pain, consistent with
current clinical guidelines. For example,
the standardized assessment of both
opioids and pain interference would
support providers in successfully
tapering patients/residents who arrive
in the PAC setting with long-term
opioid use off of opioids onto nonpharmacologic treatments and nonopioid medications, as recommended by
the Society for Post-Acute and LongTerm Care Medicine,128 and consistent
with HHS’s 5-Point Strategy To Combat
122 Chau, D.L., Walker, V., Pai, L., & Cho, L.M.
(2008). Opiates and elderly: use and side effects.
Clinical interventions in aging, 3(2), 273–8.
123 Fine, P.G. (2009). Chronic Pain Management
in Older Adults: Special Considerations. Journal of
Pain and Symptom Management, 38(2): S4–S14.
124 Solomon, D.H., Rassen, J.A., Glynn, R.J.,
Garneau, K., Levin, R., Lee, J., & Schneeweiss, S..
(2010). Archives Internal Medicine, 170(22):1979–
1986.
125 Byrd L. Managing chronic pain in older adults:
a long-term care perspective. Annals of Long-Term
Care: Clinical Care and Aging. 2013;21(12):34–40.
126 Kligler, B., Bair, M.J., Banerjea, R. et al. (2018).
Clinical Policy Recommendations from the VHA
State-of-the-Art Conference on NonPharmacological Approaches to Chronic
Musculoskeletal Pain. Journal of General Internal
Medicine, 33(Suppl 1): 16. https://doi.org/10.1007/
s11606-018-4323-z.
127 Chou, R., Deyo, R., Friedly, J., et al. (2017).
Nonpharmacologic Therapies for Low Back Pain: A
Systematic Review for an American College of
Physicians Clinical Practice Guideline. Annals of
Internal Medicine, 166(7):493–505.
128 Society for Post-Acute and Long-Term Care
Medicine (AMDA). (2018). Opioids in Nursing
Homes: Position Statement. https://paltc.org/
opioids%20in%20nursing%20homes.
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the Opioid Crisis 129 which includes
‘‘Better Pain Management.’’
The Pain Interference data elements
consist of three data elements: Pain
Effect on Sleep, Pain Interference with
Therapy Activities, and Pain
Interference with Day-to-Day Activities.
Pain Effect on Sleep assesses the
frequency with which pain effects a
resident’s sleep. Pain Interference with
Therapy Activities assesses the
frequency with which pain interferes
with a resident’s ability to participate in
therapies. The Pain Interference with
Day-to-Day Activities assesses the extent
to which pain interferes with a
resident’s ability to participate in dayto-day activities excluding therapy.
A similar data element on the effect
of pain on activities is currently
included in the OASIS. A similar data
element on the effect on sleep is
currently included in the MDS
instrument. We are proposing to expand
and modify the existing Pain data
elements in the MDS to include the Pain
Effect on Sleep; Pain Interference with
Therapy Activities; and Pain
Interference with Day to Day Activities
data elements. For more information on
the Pain Interference data elements, we
refer readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We sought public input on the
relevance of conducting assessments on
pain and specifically on the larger set of
Pain Interview data elements included
in the National Beta Test. The proposed
data elements were supported by
comments from the TEP meeting held
by our data element contractor on April
7 to 8, 2016. The TEP affirmed the
feasibility and clinical utility of pain as
a concept in a standardized assessment.
The TEP agreed that data elements on
pain interference with ability to
participate in therapies versus other
activities should be addressed. Further,
during a more recent convening of the
same TEP on September 17, 2018, the
TEP supported the interview-based pain
data elements included in the National
Beta Test. The TEP members were
particularly supportive of the items that
focused on how pain interferes with
activities (that is, Pain Interference data
elements), because understanding the
extent to which pain interferes with
129 https://www.hhs.gov/opioids/about-theepidemic/hhs-response/.
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function would enable clinicians to
determine the need for appropriate pain
treatment. A summary of the September
17, 2018 TEP meeting titled ‘‘SPADE
Technical Expert Panel Summary (Third
Convening)’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
We held a public input period in 2016
to solicit feedback on the
standardization of pain and several
other items that were under
development in prior efforts. From the
prior public comment period, we
included several pain data elements
(Pain Effect on Sleep; Pain
Interference—Therapy Activities; Pain
Interference—Other Activities) in a
second call for public input, open from
April 26 to June 26, 2017. The items we
sought comment on were modified from
all stakeholder and test efforts.
Commenters provided general
comments about pain assessment in
general in addition to feedback on the
specific pain items. A few commenters
shared their support for assessing pain,
the potential for pain assessment to
improve the quality of care, and for the
validity and reliability of the data
elements. Commenters affirmed that the
item of pain and the effect on sleep
would be suitable for PAC settings.
Commenters’ main concerns included
redundancy with existing data elements,
feasibility and utility for cross-setting
use, and the applicability of interviewbased items to patients and residents
with cognitive or communication
impairments, and deficits. A summary
report for the April 26 to June 26, 2017
public comment period titled ‘‘SPADE
May–June 2017 Public Comment
Summary Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
The Pain Interference data elements
were included in the National Beta Test
of candidate data elements conducted
by our data element contractor from
November 2017 to August 2018. Results
of this test found the Pain Interference
data elements to be feasible and reliable
for use with PAC patients and residents.
More information about the
performance of the Pain Interference
data elements in the National Beta Test
can be found in the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
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Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on
September 17, 2018 for the purpose of
soliciting input on the standardized
patient assessment data elements. The
TEP supported the interview-based pain
data elements included in the National
Beta Test. The TEP members were
particularly supportive of the items that
focused on how pain interferes with
activities (that is, Pain Interference data
elements), because understanding the
extent to which pain interferes with
function would enable clinicians to
determine the need for pain treatment.
A summary of the September 17, 2018
TEP meeting titled ‘‘SPADE Technical
Expert Panel Summary (Third
Convening)’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
Additionally, one commenter expressed
strong support for the Pain data
elements and was encouraged by the
fact that this portion of the assessment
goes beyond merely measuring the
presence of pain. A summary of the
public input received from the
November 27, 2018 stakeholder meeting
titled ‘‘Input on Standardized Patient
Assessment Data Elements (SPADEs)
Received After November 27, 2018
Stakeholder Meeting’’ is available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for the effect of pain on
function, stakeholder input, and strong
test results, we are proposing that the
three Pain Interference data elements
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(Pain Effect on Sleep, Pain Interference
with Therapy Activities, and Pain
Interference with Day-to-Day Activities)
meet the definition of standardized
patient assessment data with respect to
medical conditions and comorbidities
under section 1899B(b)(1)(B)(iv) of the
Act and to adopt the Pain Interference
data elements (Pain Effect on Sleep,
Pain Interference with Therapy
Activities, and Pain Interference with
Day-to-Day Activities) data elements as
standardized patient assessment data for
use in the SNF QRP.
e. Impairment Data
Hearing and vision impairments are
conditions that, if unaddressed, affect
activities of daily living,
communication, physical functioning,
rehabilitation outcomes, and overall
quality of life. Sensory limitations can
lead to confusion in new settings,
increase isolation, contribute to mood
disorders, and impede accurate
assessment of other medical conditions.
Failure to appropriately assess,
accommodate, and treat these
conditions increases the likelihood that
patients and residents will require more
intensive and prolonged treatment.
Onset of these conditions can be
gradual, so individualized assessment
with accurate screening tools and
follow-up evaluations are essential to
determining which patients and
residents need hearing- or visionspecific medical attention or assistive
devices and accommodations, including
auxiliary aids and/or services, and to
ensure that person-directed care plans
are developed to accommodate a
patient’s or resident’s needs. Accurate
diagnosis and management of hearing or
vision impairment would likely
improve rehabilitation outcomes and
care transitions, including transition
from institutional-based care to the
community. Accurate assessment of
hearing and vision impairment would
be expected to lead to appropriate
treatment, accommodations, including
the provision of auxiliary aids and
services during the stay, and ensure that
patients and residents continue to have
their vision and hearing needs met
when they leave the facility.
In alignment with our Meaningful
Measures Initiative, we expect accurate
and individualized assessment,
treatment, and accommodation of
hearing and vision impairments of
patients and residents in PAC to make
care safer by reducing harm caused in
the delivery of care; promote effective
prevention and treatment of chronic
disease; strengthen person and family
engagement as partners in their care;
and promote effective communication
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and coordination of care. For example,
standardized assessment of hearing and
vision impairments used in PAC will
support ensuring patient safety (for
example, risk of falls), identifying
accommodations needed during the
stay, and appropriate support needs at
the time of discharge or transfer.
Standardized assessment of these data
elements will: Enable or support clinical
decision-making and early clinical
intervention; person-centered, high
quality care (for example, facilitating
better care continuity and coordination);
better data exchange and
interoperability between settings; and
longitudinal outcome analysis.
Therefore, reliable data elements
assessing hearing and vision
impairments are needed to initiate a
management program that can optimize
a patient’s or resident’s prognosis and
reduce the possibility of adverse events.
Comments on the category of
impairments were also submitted by
stakeholders during the FY 2018 SNF
PPS proposed rule (82 FR 21074
through 21076) public comment period.
A commenter stated hearing, vision, and
communication assessments should be
administered at the beginning of
assessment process, to provide evidence
about any sensory deficits that may
affect the patient’s or resident’s ability
to participate in the assessment and to
allow the assessor to offer an assistive
device. Another commenter supported
the decision to assess hearing and vision
with respect to admission only and not
discharge, and to use existing MDS
items for hearing and vision, thereby not
creating additional burden.
We are inviting comment on our
proposals to collect as standardized
patient assessment data the following
data with respect to impairments.
(1) Hearing
We are proposing that the Hearing
data element meets the definition of
standardized patient assessment data
with respect to impairments under
section 1899B(b)(1)(B)(v) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21074 through
21075), accurate assessment of hearing
impairment is important in the PAC
setting for care planning and resource
use. Hearing impairment has been
associated with lower quality of life,
including poorer physical, mental,
social functioning, and emotional
health.130 131 Treatment and
130 Dalton D.S., Cruickshanks K.J., Klein B.E.,
Klein R, Wiley T.L., Nondahl D.M. The impact of
hearing loss on quality of life in older adults.
Gerontologist. 2003;43(5):661–668.
131 Hawkins K., Bottone F.G., Jr., Ozminkowski
R.J., et al. The prevalence of hearing impairment
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accommodation of hearing impairment
led to improved health outcomes,
including but not limited to quality of
life.132 For example, hearing loss in
elderly individuals has been associated
with depression and cognitive
impairment,133 134 135 higher rates of
incident cognitive impairment and
cognitive decline,136 and less time in
occupational therapy.137 Accurate
assessment of hearing impairment is
important in the PAC setting for care
planning and defining resource use.
The proposed data element consists of
the single Hearing data element. This
data consists of one question that
assesses level of hearing impairment.
This data element is currently in use in
the MDS in SNFs. For more information
on the Hearing data element, we refer
readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
The Hearing data element was first
proposed as a SPADE in the FY 2018
SNF PPS proposed rule (82 FR 21074
through 21075). In that proposed rule,
we stated that the proposal was
informed by input we received on the
PAC PRD form of the data element
(‘‘Ability to Hear’’) through a call for
input published on the CMS Measures
Management System Blueprint website.
Input submitted from August 12 to
September 12, 2016 recommended that
hearing, vision, and communication
assessments be administered at the
and its burden on the quality of life among adults
with Medicare Supplement Insurance. Qual Life
Res. 2012;21(7):1135–1147.
132 Horn K.L., McMahon N.B., McMahon D.C.,
Lewis J.S., Barker M., Gherini S. Functional use of
the Nucleus 22-channel cochlear implant in the
elderly. The Laryngoscope. 1991;101(3):284–288.
133 Sprinzl G.M., Riechelmann H. Current trends
in treating hearing loss in elderly people: A review
of the technology and treatment options—a minireview. Gerontology. 2010;56(3):351–358.
134 Lin F.R., Thorpe R., Gordon-Salant S., Ferrucci
L. Hearing Loss Prevalence and Risk Factors Among
Older Adults in the United States. The Journals of
Gerontology Series A: Biological Sciences and
Medical Sciences. 2011;66A(5):582–590.
135 Hawkins K., Bottone F.G., Jr., Ozminkowski
R.J., et al. The prevalence of hearing impairment
and its burden on the quality of life among adults
with Medicare Supplement Insurance. Qual Life
Res. 2012;21(7):1135–1147.
136 Lin F.R., Metter E.J., O’Brien R.J., Resnick
S.M., Zonderman A.B., Ferrucci L. Hearing Loss
and Incident Dementia. Arch Neurol.
2011;68(2):214–220.
137 Cimarolli V.R., Jung S. Intensity of
Occupational Therapy Utilization in Nursing Home
Residents: The Role of Sensory Impairments. J Am
Med Dir Assoc. 2016;17(10):939–942.
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beginning of patient assessment process.
A summary report for the August 12 to
September 12, 2016 public comment
period titled ‘‘SPADE August 2016
Public Comment Summary Report’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported Hearing as a
standardized patient assessment data
element to facilitate care coordination.
One stated that coding instructions
about use of a hearing device by the
resident should be more clearly defined.
Commenters were supportive of
adopting the Hearing data element for
standardized cross-setting use, noting
that it would help address the needs of
patient and residents with disabilities
and that failing to identify impairments
during the initial assessment can result
in inaccurate diagnoses of impaired
language or cognition and can validate
other information obtained from patient
assessment.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the Hearing
data element was included in the
National Beta Test of candidate data
elements conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the Hearing data element to be feasible
and reliable for use with PAC patients
and residents. More information about
the performance of the Hearing data
element in the National Beta Test can be
found in the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on January 5
and 6, 2017 for the purpose of soliciting
input on all the SPADEs, including the
Hearing data element. The TEP affirmed
the importance of standardized
assessment of hearing impairment in
PAC patients and residents. A summary
of the January 5 and 6, 2017 TEP
meeting titled ‘‘SPADE Technical Expert
Panel Summary (Second Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
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We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
Additionally, a commenter expressed
support for the Hearing data element
and suggested administration at the
beginning of the patient assessment to
maximize utility. A summary of the
public input received from the
November 27, 2018 stakeholder meeting
titled ‘‘Input on Standardized Patient
Assessment Data Elements (SPADEs)
Received After November 27, 2018
Stakeholder Meeting’’ is available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for hearing, stakeholder input,
and strong test results, we are proposing
that the Hearing data element meets the
definition of standardized patient
assessment data with respect to
impairments under section
1899B(b)(1)(B)(v) of the Act and to
adopt the Hearing data element as
standardized patient assessment data for
use in the SNF QRP.
(2) Vision
We are proposing that the Vision data
element meets the definition of SPADE
with respect to impairments under
section 1899B(b)(1)(B)(v) of the Act.
As described in the FY 2018 SNF PPS
proposed rule (82 FR 21075 through
21076), evaluation of an individual’s
ability to see is important for assessing
for risks such as falls and provides
opportunities for improvement through
treatment and the provision of
accommodations, including auxiliary
aids and services, which can safeguard
patients and residents and improve
their overall quality of life. Further,
vision impairment is often a treatable
risk factor associated with adverse
events and poor quality of life. For
example, individuals with visual
impairment are more likely to
experience falls and hip fracture, have
less mobility, and report depressive
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symptoms.138 139 140 141 142 143 144
Individualized initial screening can lead
to life-improving interventions such as
accommodations, including the
provision of auxiliary aids and services,
during the stay and/or treatments that
can improve vision and prevent or slow
further vision loss. In addition, vision
impairment is often a treatable risk
factor associated with adverse events
which can be prevented and
accommodated during the stay.
Accurate assessment of vision
impairment is important in the SNF
setting for care planning and defining
resource use.
The proposed data element consists of
the single Vision data element (Ability
To See in Adequate Light) that consists
of one question with five response
categories. The Vision data element that
we are proposing for standardization
was tested as part of the development of
the MDS in SNFs and is currently in use
in that assessment. Similar data
elements, but with different wording
and fewer response option categories,
are in use in the OASIS. For more
information on the Vision data element,
we refer readers to the document titled
‘‘Proposed Specifications for SNF QRP
Quality Measures and Standardized
Patient Assessment Data Elements,’’
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
The Vision data element was first
proposed as a SPADE in the FY 2018
SNF PPS proposed rule (82 FR 21075
through 21076). In that proposed rule,
we stated that the proposal was
informed by input we received on the
138 Colon-Emeric CS, Biggs DP, Schenck AP, Lyles
KW. Risk factors for hip fracture in skilled nursing
facilities: who should be evaluated? Osteoporos Int.
2003;14(6):484–489.
139 Freeman EE, Munoz B, Rubin G, West SK.
Visual field loss increases the risk of falls in older
adults: the Salisbury eye evaluation. Invest
Ophthalmol Vis Sci. 2007;48(10):4445–4450.
140 Keepnews D, Capitman JA, Rosati RJ.
Measuring patient-level clinical outcomes of home
health care. J Nurs Scholarsh. 2004;36(1):79–85.
141 Nguyen HT, Black SA, Ray LA, Espino DV,
Markides KS. Predictors of decline in MMSE scores
among older Mexican Americans. J Gerontol A Biol
Sci Med Sci. 2002;57(3):M181–185.
142 Prager AJ, Liebmann JM, Cioffi GA, Blumberg
DM. Self-reported Function, Health Resource Use,
and Total Health Care Costs Among Medicare
Beneficiaries With Glaucoma. JAMA
ophthalmology. 2016;134(4):357–365.
143 Rovner BW, Ganguli M. Depression and
disability associated with impaired vision: the
MoVies Project. J Am Geriatr Soc. 1998;46(5):617–
619.
144 Tinetti ME, Ginter SF. The nursing home lifespace diameter. A measure of extent and frequency
of mobility among nursing home residents. J Am
Geriatr Soc. 1990;38(12):1311–1315.
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Ability to See in Adequate Light data
element (version tested in the PAC PRD
with three response categories) through
a call for input published on the CMS
Measures Management System
Blueprint website. Although the data
element in public comment differed
from the proposed data element, input
submitted from August 12 to September
12, 2016 supported assessing vision in
PAC settings and the useful information
a vision data element would provide.
We also stated that commenters had
noted that the Ability to See item would
provide important information that
would facilitate care coordination and
care planning, and consequently
improve the quality of care. Other
commenters suggested it would be
helpful as an indicator of resource use
and noted that the item would provide
useful information about the abilities of
patients and residents to care for
themselves. Additional commenters
noted that the item could feasibly be
implemented across PAC providers and
that its kappa scores from the PAC PRD
support its validity. Some commenters
noted a preference for MDS version of
the Vision data element in SNFs over
the form put forward in public
comment, citing the widespread use of
this data element. A summary report for
the August 12 to September 12, 2016
public comment period titled ‘‘SPADE
August 2016 Public Comment Summary
Report’’ is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In response to our proposal in the FY
2018 SNF PPS proposed rule, two
commenters supported Vision as a
standardized patient assessment data
element to facilitate care coordination.
One stated that coding instructions for
use of a vision device by the resident
should be more clearly defined.
Commenters recommended that hearing,
vision, and communication assessments
be administered at the beginning of
patient assessment process. One
commenter supported having a SPADE
for vision across PAC settings, but stated
it captures only basic information for
risk adjustment, and more detailed
information would need to be collected
to use it as an outcome measure.
Subsequent to receiving comments on
the FY 2018 SNF PPS rule, the Vision
data element was included in the
National Beta Test of candidate data
elements conducted by our data element
contractor from November 2017 to
August 2018. Results of this test found
the Vision data element to be feasible
PO 00000
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Fmt 4701
Sfmt 4702
and reliable for use with PAC patients
and residents. More information about
the performance of the Vision data
element in the National Beta Test can be
found in the document titled ‘‘Proposed
Specifications for SNF QRP Quality
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In addition, our data element
contractor convened a TEP on January 5
and 6, 2017 for the purpose of soliciting
input on all the SPADEs including the
Vision data element. The TEP affirmed
the importance of standardized
assessment of vision impairment in PAC
patients and residents. A summary of
the January 5 and 6, 2017 TEP meeting
titled ‘‘SPADE Technical Expert Panel
Summary (Second Convening)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
We also held Special Open Door
Forums and small-group discussions
with PAC providers and other
stakeholders in 2018 for the purpose of
updating the public about our on-going
SPADE development efforts. Finally, on
November 27, 2018, our data element
contractor hosted a public meeting of
stakeholders to present the results of the
National Beta Test and solicit additional
comments. General input on the testing
and item development process and
concerns about burden were received
from stakeholders during this meeting
and via email through February 1, 2019.
Additionally, a commenter expressed
support for the Vision data element and
suggested administration at the
beginning of the patient assessment to
maximize utility. A summary of the
public input received from the
November 27, 2018 stakeholder meeting
titled ‘‘Input on Standardized Patient
Assessment Data Elements (SPADEs)
Received After November 27, 2018
Stakeholder Meeting’’ is available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Taking together the importance of
assessing for vision, stakeholder input,
and strong test results, we are proposing
that the Vision data element meets the
definition of standardized patient
assessment data with respect to
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impairments under section
1899B(b)(1)(B)(v) of the Act and to
adopt the Vision data element as
standardized patient assessment data for
use in the SNF QRP.
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f. Proposed New Category: Social
Determinants of Health
(1) Proposed Social Determinants of
Health Data Collection To Inform
Measures and Other Purposes
Subparagraph (A) of section 2(d)(2) of
the IMPACT Act requires CMS to assess
appropriate adjustments to quality
measures, resource measures, and other
measures, and to assess and implement
appropriate adjustments to payment
under Medicare based on those
measures, after taking into account
studies conducted by ASPE on social
risk factors (described below) and other
information, and based on an
individual’s health status and other
factors. Subparagraph (C) of section
2(d)(2) of the IMPACT Act further
requires the Secretary to carry out
periodic analyses, at least every three
years, based on the factors referred to
subparagraph (A) so as to monitor
changes in possible relationships.
Subparagraph (B) of section 2(d)(2) of
the IMPACT Act requires CMS to collect
or otherwise obtain access to data
necessary to carry out the requirement
of the paragraph (both assessing
adjustments described above in such
subparagraph (A) and for periodic
analyses in such subparagraph (C)).
Accordingly we are proposing to use our
authority under subparagraph (B) of
section 2(d)(2) of the IMPACT Act to
establish a new data source for
information to meet the requirements of
subparagraphs (A) and (C) of section
2(d)(2) of the IMPACT Act. In this rule,
we are proposing to collect and access
data about social determinants of health
(SDOH) to perform CMS’
responsibilities under subparagraphs
(A) and (C) of section 2(d)(2) of the
IMPACT Act, as explained in more
detail below. Social determinants of
health, also known as social risk factors,
or health-related social needs, are the
socioeconomic, cultural and
environmental circumstances in which
individuals live that impact their health.
We are proposing to collect information
on seven proposed SDOH SPADE data
elements relating to race, ethnicity,
preferred language, interpreter services,
health literacy, transportation, and
social isolation; a detailed discussion of
each of the proposed SDOH data
elements is found in section VI.A.7.f.(2)
of this proposed rule.
We are also proposing to use the
resident assessment instrument
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minimum data set (MDS), the current
version being MDS 3.0, described as a
PAC assessment instrument under
section 1899B(a)(2)(B) of the Act, to
collect these data via an existing data
collection mechanism. We believe this
approach will provide CMS with access
to data with respect to the requirements
of section 2(d)(2) of the IMPACT Act,
while minimizing the reporting burden
on PAC health care providers by relying
on a data reporting mechanism already
used and an existing system to which
PAC health care providers are already
accustomed.
The IMPACT Act includes several
requirements applicable to the
Secretary, in addition to those imposing
new data reporting obligations on
certain PAC providers as discussed in
section VI.A.7.f.(2) of this proposed
rule. Subparagraphs (A) and (B) of
section 2(d)(1) of the IMPACT Act
require the Secretary, acting through the
Office of the Assistant Secretary for
Planning and Evaluation (ASPE), to
conduct two studies that examine the
effect of risk factors, including
individuals’ socioeconomic status, on
quality, resource use and other
measures under the Medicare program.
The first ASPE study was completed in
December 2016 and is discussed below,
and the second study is to be completed
in the fall of 2019. We recognize that
ASPE, in its studies, is considering a
broader range of social risk factors than
the SDOH data elements in this
proposal, and address both PAC and
non-PAC settings. We acknowledge that
other data elements may be useful to
understand, and that some of those
elements may be of particular interest in
non-PAC settings. For example, for
beneficiaries receiving care in the
community, as opposed to an in-patient
facility, housing stability and food
insecurity may be more relevant. We
will continue to take into account the
findings from both of ASPE’s reports in
future policy making.
One of the ASPE’s first actions under
the IMPACT Act was to commission the
National Academies of Sciences,
Engineering, and Medicine (NASEM) to
define and conceptualize socioeconomic
status for the purposes of ASPE’s two
studies under section 2(d)(1) of the
IMPACT Act. The NASEM convened a
panel of experts in the field and
conducted an extensive literature
review. Based on the information
collected, the 2016 NASEM panel report
titled, ‘‘Accounting for Social Risk
Factors in Medicare Payment:
Identifying Social Risk Factors,’’
concluded that the best way to assess
how social processes and social
relationships influence key health-
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related outcomes in Medicare
beneficiaries is through a framework of
social risk factors instead of
socioeconomic status. Social risk factors
discussed in the NASEM report include
socioeconomic position, race, ethnicity,
gender, social context, and community
context. These factors are discussed at
length in chapter 2 of the NASEM
report, titled ‘‘Social Risk Factors.’’ 145
Consequently NASEM framed the
results of its report in terms of ‘‘social
risk factors’’ rather than ‘‘socioeconomic
status’’ or ‘‘sociodemographic status.’’
The full text of the ‘‘Social Risk Factors’’
NASEM report is available for reading
on the website at https://www.nap.edu/
read/21858/chapter/1.
Each of the data elements we are
proposing to collect and access pursuant
to our authority under section 2(d)(2)(B)
of the IMPACT Act is identified in the
2016 NASEM report as a social risk
factor that has been shown to impact
care use, cost and outcomes for
Medicare beneficiaries. CMS uses the
term social determinants of health
(SDOH) to denote social risk factors,
which is consistent with the objectives
of Healthy People 2020.146
ASPE issued its first Report to
Congress, titled ‘‘Social Risk Factors and
Performance Under Medicare’s ValueBased Purchasing Programs,’’ pursuant
to section 2(d)(1)(A) of the IMPACT Act
on December 21, 2016.147 Using
NASEM’s social risk factors framework,
ASPE focused on the following social
risk factors, in addition to disability: (1)
Dual enrollment in Medicare and
Medicaid as a marker for low income,
(2) residence in a low-income area, (3)
Black race, (4) Hispanic ethnicity, and;
(5) residence in a rural area. ASPE
acknowledged that the social risk factors
examined in its report were limited due
to data availability. The report also
noted that the data necessary to
meaningfully attempt to reduce
disparities and identify and reward
improved outcomes for beneficiaries
with social risk factors have not been
collected consistently on a national
level in post-acute care settings. Where
these data have been collected, the
145 National Academies of Sciences, Engineering,
and Medicine. 2016. Accounting for social risk
factors in Medicare payment: Identifying social risk
factors. Chapter 2. Washington, DC: The National
Academies Press.
146 Social Determinants of Health. Healthy People
2020. https://www.healthypeople.gov/2020/topicsobjectives/topic/social-determinants-of-health.
(February 2019).
147 U.S. Department of Health and Human
Services, Office of the Assistant Secretary for
Planning and Evaluation. 2016. Report to Congress:
Social Risk Factors and Performance Under
Medicare’s Value-Based Payment Programs.
Washington, DC.
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collection frequently involves lengthy
questionnaires. More information on the
Report to Congress on Social Risk
Factors and Performance under
Medicare’s Value-Based Purchasing
Programs, including the full report, is
available on the website at https://
aspe.hhs.gov/social-risk-factors-andmedicares-value-based-purchasingprograms-reports.
Section 2(d)(2) of the IMPACT Act
relates to CMS activities and imposes
several responsibilities on the Secretary
relating to quality, resource use, and
other measures under Medicare. As
mentioned previously, under
subparagraph (A) of section 2(d)(2) of
the IMPACT Act, the Secretary is
required, on an ongoing basis, taking
into account the ASPE studies and other
information, and based on an
individual’s health status and other
factors, to assess appropriate
adjustments to quality, resource use,
and other measures, and to assess and
implement appropriate adjustments to
Medicare payments based on those
measures. Section 2(d)(2)(A)(i) of the
IMPACT Act applies to measures
adopted under subsections (c) and (d) of
section 1899B of the Act and to other
measures under Medicare. However,
CMS’ ability to perform these analyses,
and assess and make appropriate
adjustments is hindered by limits of
existing data collections on SDOH data
elements for Medicare beneficiaries. In
its first study in 2016, in discussing the
second study, ASPE noted that
information relating to many of the
specific factors listed in the IMPACT
Act, such as health literacy, limited
English proficiency, and Medicare
beneficiary activation, are not available
in Medicare data.
Subparagraph 2(d)(2)(A) of the
IMPACT Act specifically requires the
Secretary to take the studies and
considerations from ASPE’s reports to
Congress, as well as other information
as appropriate, into account in assessing
and implementing adjustments to
measures and related payments based
on measures in Medicare. The results of
the ASPE’s first study demonstrated that
Medicare beneficiaries with social risk
factors tended to have worse outcomes
on many quality measures, and
providers who treated a
disproportionate share of beneficiaries
with social risk factors tended to have
worse performance on quality measures.
As a result of these findings, ASPE
suggested a three-pronged strategy to
guide the development of value-based
payment programs under which all
Medicare beneficiaries receive the
highest quality healthcare services
possible. The three components of this
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strategy are to: (1) Measure and report
quality of care for beneficiaries with
social risk factors; (2) set high, fair
quality standards for care provided to
all beneficiaries; and (3) reward and
support better outcomes for
beneficiaries with social risk factors. In
discussing how measuring and reporting
quality for beneficiaries with social risk
factors can be applied to Medicare
quality payment programs, the report
offered nine considerations across the
three-pronged strategy, including
enhancing data collection and
developing statistical techniques to
allow measurement and reporting of
performance for beneficiaries with
social risk factors on key quality and
resource use measures.
Congress, in section 2(d)(2)(B) of the
IMPACT Act, required the Secretary to
collect or otherwise obtain access to the
data necessary to carry out the
provisions of paragraph (2) of section
2(d) of the IMPACT Act through both
new and existing data sources. Taking
into consideration NASEM’s conceptual
framework for social risk factors
discussed above, ASPE’s study,
considerations under section 2(d)(1)(A)
of the IMPACT Act, as well as the
current data constraints of ASPE’s first
study and its suggested considerations,
we are proposing to collect and access
data about SDOH under section 2(d)(2)
of the IMPACT Act. Our collection and
use of the SDOH data described in
section VI.A.7.f.(1) of this proposed
rule, under section 2(d)(2) of the
IMPACT Act, would be independent of
our proposal below (in section
VI.A.7.f.(2) of this proposed rule and
our authority to require submission of
that data for use as SPADE under
section 1899B(a)(1)(B) of the Act.
Accessing standardized data relating
to the SDOH data elements on a national
level is necessary to permit CMS to
conduct periodic analyses, to assess
appropriate adjustments to quality
measures, resource use measures, and
other measures, and to assess and
implement appropriate adjustments to
Medicare payments based on those
measures. We agree with ASPE’s
observations, in the value-based
purchasing context, that the ability to
measure and track quality, outcomes,
and costs for beneficiaries with social
risk factors over time is critical as
policymakers and providers seek to
reduce disparities and improve care for
these groups. Collecting the data as
proposed will provide the basis for our
periodic analyses of the relationship
between an individual’s health status
and other factors and quality, resource
use, and other measures, as required by
section 2(d)(2) of the IMPACT Act, and
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to assess appropriate adjustments. These
data will also permit us to develop the
statistical tools necessary to maximize
the value of Medicare data, reduce costs
and improve the quality of care for all
beneficiaries. Collecting and accessing
SDOH data in this way also supports the
three-part strategy put forth in the first
ASPE report, specifically ASPE’s
consideration to enhance data collection
and develop statistical techniques to
allow measurement and reporting of
performance for beneficiaries with
social risk factors on key quality and
resource use measures.
For the reasons discussed above, we
are proposing under section 2(d)(2) of
the IMPACT Act, to collect the data on
the following SDOH: (1) Race, as
described in section VI.A.7.f.(2)(a) of
this proposed rule; (2) Ethnicity, as
described in section VI.A.7.f.(2)(a) of
this proposed rule; (3) Preferred
Language, as described in section
VI.A.7.f.(2)(b) of this proposed rule; (4)
Interpreter Services as described in
section VI.A.7.f.(2)(b) of this proposed
rule; (5) Health Literacy, as described in
section VI.A.7.f.(2)(c) of this proposed
rule; (6) Transportation, as described in
section VI.A.7.f.(2)(d) of this proposed
rule; and (5) Social Isolation, as
described in section VI.A.7.f.(2)(e) of
this proposed rule. These data elements
are discussed in more detail below in
section VI.A.7.f.(2) of this proposed
rule. We welcome comment on this
proposal.
(2) Standardized Patient Assessment
Data
Section 1899B(b)(1)(B)(vi) of the Act
authorizes the Secretary to collect
SPADEs with respect to other categories
deemed necessary and appropriate.
Below we are proposing to create a
Social Determinants of Health SPADE
category under section
1899B(b)(1)(B)(vi) of the Act. In addition
to collecting SDOH data for the
purposes outlined above under section
2(d)(2)(B) of the IMPACT Act, we are
also proposing to collect as SPADE
these same data elements (race,
ethnicity, preferred language, interpreter
services, health literacy, transportation,
and social isolation) under section
1899B(b)(1)(B)(vi) of the Act. We believe
that this proposed new category of
Social Determinants of Health will
inform provider understanding of
individual patient risk factors and
treatment preferences, facilitate
coordinated care and care planning, and
improve patient outcomes. We are
proposing to deem this category
necessary and appropriate, for the
purposes of SPADE, because using
common standards and definitions for
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PAC data elements is important in
ensuring interoperable exchange of
longitudinal information between PAC
providers and other providers to
facilitate coordinated care, continuity in
care planning, and the discharge
planning process from post-acute care
settings.
All of the Social Determinants of
Health data elements we are proposing
under section 1899B(b)(1)(B)(vi) of the
Act have the capacity to take into
account treatment preferences and care
goals of residents and patients, and to
inform our understanding of resident
and patient complexity and risk factors
that may affect care outcomes. While
acknowledging the existence and
importance of additional SDOH, we are
proposing to assess some of the factors
relevant for patients and residents
receiving post-acute care that PAC
settings are in a position to impact
through the provision of services and
supports, such as connecting patients
and residents with identified needs with
transportation programs, certified
interpreters, or social support programs.
As previously mentioned and
described in more detail below we are
proposing to adopt the following seven
data elements as SPADE under the
proposed Social Determinants of Health
category: Race, ethnicity, preferred
language, interpreter services, health
literacy, transportation, and social
isolation. To select these data elements,
we reviewed the research literature, a
number of validated assessment tools
and frameworks for addressing SDOH
currently in use (for example, Health
Leads, NASEM, Protocol for Responding
to and Assessing Patients’ Assets, Risks,
and Experiences (PRAPARE), and ICD–
10), and we engaged in discussions with
stakeholders. We also prioritized
balancing the reporting burden for PAC
providers with our policy objective to
collect SPADEs that will inform care
planning and coordination and quality
improvement across care settings.
Furthermore, incorporating SDOH data
elements into care planning has the
potential to reduce readmissions and
help beneficiaries achieve and maintain
their health goals.
We also considered feedback received
during a listening session that we held
on December 13, 2018. The purpose of
the listening session was to solicit
feedback from health systems, research
organizations, advocacy organizations
and state agencies, and other members
of the public on collecting patient-level
data on SDOH across care settings,
including consideration of race,
ethnicity, spoken language, health
literacy, social isolation, transportation,
sex, gender identity, and sexual
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orientation. We also gave participants
an option to submit written comments.
A full summary of the listening session,
titled ‘‘Listening Session on Social
Determinants of Health Data Elements:
Summary of Findings,’’ includes a list of
participating stakeholders and their
affiliations, and is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
(a) Race and Ethnicity
The persistence of racial and ethnic
disparities in health and health care is
widely documented, including in PAC
settings.148 149 150 151 152 Despite the trend
toward overall improvements in quality
of care and health outcomes, the Agency
for Healthcare Research and Quality, in
its National Healthcare Quality and
Disparities Reports, consistently
indicates that racial and ethnic
disparities persist, even after controlling
for factors such as income, geography,
and insurance.153 For example, racial
and ethnic minorities tend to have
higher rates of infant mortality, diabetes
and other chronic conditions, and visits
to the emergency department, and lower
rates of having a usual source of care
and receiving immunizations such as
the flu vaccine.154 Studies have also
shown that African Americans are
significantly more likely than white
Americans to die prematurely from
heart disease and stroke.155 However,
148 2017 National Healthcare Quality and
Disparities Report. Rockville, MD: Agency for
Healthcare Research and Quality; September 2018.
AHRQ Pub. No. 18–0033–EF.
149 Fiscella, K. and Sanders, M.R. Racial and
Ethnic Disparities in the Quality of Health Care.
(2016). Annual Review of Public Health. 37:375–
394.
150 2018 National Impact Assessment of the
Centers for Medicare & Medicaid Services (CMS)
Quality Measures Reports. Baltimore, MD: U.S.
Department of Health and Human Services, Centers
for Medicare and Medicaid Services; February 28,
2018.
151 Smedley, B.D., Stith, A.Y., & Nelson, A.R.
(2003). Unequal treatment: confronting racial and
ethnic disparities in health care. Washington, DC,
National Academy Press.
152 Chase, J., Huang, L. and Russell, D. (2017).
Racial/ethnic disparities in disability outcomes
among post-acute home care patients. J of Aging
and Health. 30(9):1406–1426.
153 National Healthcare Quality and Disparities
Reports. (December 2018). Agency for Healthcare
Research and Quality, Rockville, MD. https://
www.ahrq.gov/research/findings/nhqrdr/
index.html.
154 National Center for Health Statistics. Health,
United States, 2017: With special feature on
mortality. Hyattsville, Maryland. 2018.
155 HHS. Heart disease and African Americans.
2016b. (October 24, 2016). https://
minorityhealth.hhs.gov/omh/
browse.aspx?lvl=4&lvlid=19.
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our ability to identify and address racial
and ethnic health disparities has
historically been constrained by data
limitations, particularly for smaller
populations groups such as Asians,
American Indians and Alaska Natives,
and Native Hawaiians and other Pacific
Islanders.156
The ability to improve understanding
of and address racial and ethnic
disparities in PAC outcomes requires
the availability of better data. There is
currently a Race and Ethnicity data
element, collected in the MDS, LCDS,
IRF–PAI, and OASIS, that consists of a
single question, which aligns with the
1997 Office of Management and Budget
(OMB) minimum data standards for
federal data collection efforts.157 The
1997 OMB Standard lists five minimum
categories of race: (1) American Indian
or Alaska Native; (2) Asian; (3) Black or
African American; (4) Native Hawaiian
or Other Pacific Islander; (5) and White.
The 1997 OMB Standard also lists two
minimum categories of ethnicity: (1)
Hispanic or Latino, and (2) Not Hispanic
or Latino. The 2011 HHS Data Standards
requires a two-question format when
self-identification is used to collect data
on race and ethnicity. Large federal
surveys such as the National Health
Interview Survey, Behavioral Risk
Factor Surveillance System, and the
National Survey on Drug Use and
Health, have implemented the 2011
HHS race and ethnicity data standards.
CMS has similarly updated the
Medicare Current Beneficiary Survey,
Medicare Health Outcomes Survey, and
the Health Insurance Marketplace
Application for Health Coverage with
the 2011 HHS data standards. More
information about the HHS Race and
Ethnicity Data Standards are available
on the website at https://
minorityhealth.hhs.gov/omh/
browse.aspx?lvl=3&lvlid=54.
We are proposing to revise the current
Race and Ethnicity data element for
purposes of this proposal to conform to
the 2011 HHS Data Standards for
person-level data collection, while also
meeting the 1997 OMB minimum data
156 National Academies of Sciences, Engineering,
and Medicine; Health and Medicine Division; Board
on Population Health and Public Health Practice;
Committee on Community-Based Solutions to
Promote Health Equity in the United States; Baciu
A, Negussie Y, Geller A, et al., editors.
Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US);
2017 Jan 11. 2, The State of Health Disparities in
the United States. Available from: https://
www.ncbi.nlm.nih.gov/books/NBK425844/.
157 ‘‘Revisions to the Standards for the
Classification of Federal Data on Race and Ethnicity
(Notice of Decision)’’. Federal Register 62:210
(October 30, 1997) pp. 58782–58790. Available
from: https://www.govinfo.gov/content/pkg/FR1997-10-30/pdf/97-28653.pdf.
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standards for race and ethnicity. Rather
than one data element that assesses both
race and ethnicity, we are proposing
two separate data elements: One for
Race and one for Ethnicity, that would
conform with the 2011 HHS Data
Standards and the 1997 OMB Standard.
In accordance with the 2011 HHS Data
Standards, a two-question format would
be used for the proposed race and
ethnicity data elements.
The proposed Race data element asks,
‘‘What is your race?’’ We are proposing
to include fourteen response options
under the race data element: (1) White;
(2) Black or African American; (3)
American Indian or Alaska Native; (4)
Asian Indian; (5) Chinese; (6) Filipino;
(7) Japanese; (8) Korean; (9) Vietnamese;
(10) Other Asian; (11) Native Hawaiian;
(12) Guamanian or Chamorro; (13)
Samoan; and, (14) Other Pacific
Islander.
The proposed Ethnicity data element
asks, ‘‘Are you Hispanic, Latino/a, or
Spanish origin?’’ We are proposing to
include five response options under the
ethnicity data element: (1) Not of
Hispanic, Latino/a, or Spanish origin;
(2) Mexican, Mexican American,
Chicano/a; (3) Puerto Rican; (4) Cuban;
and, (5) Another Hispanic, Latino, or
Spanish Origin.
We believe that the two proposed data
elements for race and ethnicity conform
to the 2011 HHS Data Standards for
person-level data collection, while also
meeting the 1997 OMB minimum data
standards for race and ethnicity,
because under those standards, more
detailed information on population
groups can be collected if those
additional categories can be aggregated
into the OMB minimum standard set of
categories.
In addition, we received stakeholder
feedback during the December 13, 2018
SDOH listening session on the
importance of improving response
options for race and ethnicity as a
component of health care assessments
and for monitoring disparities. Some
stakeholders emphasized the
importance of allowing for selfidentification of race and ethnicity for
more categories than are included in the
2011 HHS Standard to better reflect
state and local diversity, while
acknowledging the burden of coding an
open-ended health care assessment
question across different settings.
We believe that the proposed
modified race and ethnicity data
elements more accurately reflect the
diversity of the U.S. population than the
current race/ethnicity data element
included in MDS, LCDS, IRF–PAI and,
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OASIS.158 159 160 161 We believe, and
research consistently shows, that
improving how race and ethnicity data
are collected is an important first step
in improving quality of care and health
outcomes. Addressing disparities in
access to care, quality of care, and
health outcomes for Medicare
beneficiaries begins with identifying
and analyzing how SDOH, such as race
and ethnicity, align with disparities in
these areas.162 Standardizing selfreported data collection for race and
ethnicity allows for the equal
comparison of data across multiple
healthcare entities.163 By collecting and
analyzing these data, CMS and other
healthcare entities will be able to
identify challenges and monitor
progress. The growing diversity of the
US population and knowledge of racial
and ethnic disparities within and across
population groups supports the
collection of more granular data beyond
the 1997 OMB minimum standard for
reporting categories. The 2011 HHS race
and ethnicity data standard includes
additional detail that may be used by
PAC providers to target quality
improvement efforts for racial and
ethnic groups experiencing disparate
outcomes. For more information on the
Race and Ethnicity data elements, we
refer readers to the document titled
‘‘Proposed Specifications for SNF QRP
Measures and Standardized Patient
Assessment Data Elements,’’ available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment158 Penman-Aguilar, A., Talih, M., Huang, D.,
Moonesinghe, R., Bouye, K., Beckles, G. (2016).
Measurement of Health Disparities, Health
Inequities, and Social Determinants of Health to
Support the Advancement of Health Equity. J Public
Health Manag Pract. 22 Suppl 1: S33–42.
159 Ramos, R., Davis, J.L., Ross, T., Grant, C.G.,
Green, B.L. (2012). Measuring health disparities and
health inequities: do you have REGAL data? Qual
Manag Health Care. 21(3):176–87.
160 IOM (Institute of Medicine). 2009. Race,
Ethnicity, and Language Data: Standardization for
Health Care Quality Improvement. Washington, DC:
The National Academies Press.
161 ‘‘Revision of Standards for Maintaining,
Collecting, and Presenting Federal Data on Race and
Ethnicity: Proposals From Federal Interagency
Working Group (Notice and Request for
Comments).’’ Federal Register 82: 39 (March 1,
2017) p. 12242.
162 National Academies of Sciences, Engineering,
and Medicine; Health and Medicine Division; Board
on Population Health and Public Health Practice;
Committee on Community-Based Solutions to
Promote Health Equity in the United States; Baciu
A, Negussie Y, Geller A, et al., editors.
Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US);
2017 Jan 11. 2, The State of Health Disparities in
the United States. Available from: https://
www.ncbi.nlm.nih.gov/books/NBK425844/.
163 IOM (Institute of Medicine). 2009. Race,
Ethnicity, and Language Data: Standardization for
Health Care Quality Improvement. Washington, DC:
The National Academies Press.
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Instruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
In an effort to standardize the
submission of race and ethnicity data
among IRFs, HHAs, SNFs and LTCHs,
for the purposes outlined in section
1899B(a)(1)(B) of the Act, while
minimizing the reporting burden, we are
proposing to adopt the Race and
Ethnicity data elements described above
as SPADEs with respect to the proposed
Social Determinants of Health category.
Specifically, we are proposing to
replace the current Race/Ethnicity data
element with the proposed Race and
Ethnicity data elements on the MDS. We
are also proposing that SNFs that submit
the Race and Ethnicity data elements
with respect to admission will be
considered to have submitted with
respect to discharge as well, because it
is unlikely that the results of these
assessment findings will change
between the start and end of the SNF
stay, making the information submitted
with respect to a resident’s admission
the same with respect to a resident’s
discharge.
(b) Preferred Language and Interpreter
Services
More than 64 million Americans
speak a language other than English at
home, and nearly 40 million of those
individuals have limited English
proficiency (LEP).164 Individuals with
LEP have been shown to receive worse
care and have poorer health outcomes,
including higher readmission
rates.165 166 167 Communication with
individuals with LEP is an important
component of high quality health care,
which starts by understanding the
population in need of language services.
Unaddressed language barriers between
a patient and provider care team
negatively affects the ability to identify
and address individual medical and
non-medical care needs, to convey and
understand clinical information, as well
as discharge and follow up instructions,
all of which are necessary for providing
164 U.S. Census Bureau, 2013–2017 American
Community Survey 5-Year Estimates.
165 Karliner LS, Kim SE, Meltzer DO, Auerbach
AD. Influence of language barriers on outcomes of
hospital care for general medicine inpatients. J
Hosp Med. 2010 May-Jun;5(5):276–82. doi: 10.1002/
jhm.658.
166 Kim EJ, Kim T, Paasche-Orlow MK, et al.
Disparities in Hypertension Associated with
Limited English Proficiency. J Gen Intern Med. 2017
Jun;32(6):632–639. doi: 10.1007/s11606–017–3999–
9.
167 National Academies of Sciences, Engineering,
and Medicine. 2016. Accounting for social risk
factors in Medicare payment: Identifying social risk
factors. Washington, DC: The National Academies
Press.
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high quality care. Understanding the
communication assistance needs of
residents and patients with LEP,
including individuals who are Deaf or
hard of hearing, is critical for ensuring
good outcomes.
Presently, the preferred language of
residents and patients and need for
interpreter services are assessed in two
PAC assessment tools. The LCDS and
the MDS use the same two data
elements to assess preferred language
and whether a patient or resident needs
or wants an interpreter to communicate
with health care staff. The MDS initially
implemented preferred language and
interpreter services data elements to
assess the needs of SNF residents and
patients and inform care planning. For
alignment purposes, the LCDS later
adopted the same data elements for
LTCHs. The 2009 NASEM (formerly
Institute of Medicine) report on
standardizing data for health care
quality improvement emphasizes that
language and communication needs
should be assessed as a standard part of
health care delivery and quality
improvement strategies.168
In developing our proposal for a
standardized language data element
across PAC settings, we considered the
current preferred language and
interpreter services data elements that
are in LCDS and MDS. We also
considered the 2011 HHS Primary
Language Data Standard and peerreviewed research. The current
preferred language data element in
LCDS and MDS asks, ‘‘What is your
preferred language?’’ Because the
preferred language data element is openended, the patient or resident is able to
identify their preferred language,
including American Sign Language
(ASL). Finally, we considered the
recommendations from the 2009
NASEM (formerly Institute of Medicine)
report, ‘‘Race, Ethnicity, and Language
Data: Standardization for Health Care
Quality Improvement.’’ In it, the
committee recommended that
organizations evaluating a patient’s
language and communication needs for
health care purposes, should collect
data on the preferred spoken language
and on an individual’s assessment of
his/her level of English proficiency.
A second language data element in
LCDS and MDS asks, ‘‘Do you want or
need an interpreter to communicate
with a doctor or health care staff?’’ and
includes yes or no response options. In
contrast, the 2011 HHS Primary
168 IOM (Institute of Medicine). 2009. Race,
Ethnicity, and Language Data: Standardization for
Health Care Quality Improvement. Washington, DC:
The National Academies Press.
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Language Data Standard recommends
either a single question to assess how
well someone speaks English or, if more
granular information is needed, a twopart question to assess whether a
language other than English is spoken at
home and if so, identify that language.
However, neither option allows for a
direct assessment of a patient’s or
resident’s preferred spoken or written
language nor whether they want or need
interpreter services for communication
with a doctor or care team, both of
which are an important part of assessing
resident and patient needs and the care
planning process. More information
about the HHS Data Standard for
Primary Language is available on the
website at https://
minorityhealth.hhs.gov/omh/
browse.aspx?lvl=3&lvlid=54.
Research consistently recommends
collecting information about an
individual’s preferred spoken language
and evaluating those responses for
purposes of determining language
access needs in health care.169 However,
using ‘‘preferred spoken language’’ as
the metric does not adequately account
for people whose preferred language is
ASL, which would necessitate adopting
an additional data element to identify
visual language. The need to improve
the assessment of language preferences
and communication needs across PAC
settings should be balanced with the
burden associated with data collection
on the provider and patient or resident.
Therefore we are proposing to retain the
Preferred Language and Interpreter
Services data elements currently in use
on the MDS.
In addition, we received feedback
during the December 13, 2018 listening
session on the importance of evaluating
and acting on language preferences early
to facilitate communication and
allowing for patient self-identification of
preferred language. Although the
discussion about language was focused
on preferred spoken language, there was
general consensus among participants
that stated language preferences may or
may not accurately indicate the need for
interpreter services, which supports
collecting and evaluating data to
determine language preference, as well
as the need for interpreter services. An
alternate suggestion was made to
inquire about preferred language
169 Guerino, P. and James, C. Race, Ethnicity, and
Language Preference in the Health Insurance
Marketplaces 2017 Open Enrollment Period.
Centers for Medicare & Medicaid Services, Office of
Minority Health. Data Highlight: Volume 7—April
2017. Available at https://www.cms.gov/AboutCMS/Agency-Information/OMH/Downloads/DataHighlight-Race-Ethnicity-and-Language-PreferenceMarketplace.pdf.
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17675
specifically for discussing health or
health care needs. While this suggestion
does allow for ASL as a response option,
we do not have data indicating how
useful this question might be for
assessing the desired information and
thus we are not including this question
in our proposal.
Improving how preferred language
and need for interpreter services data
are collected is an important component
of improving quality by helping PAC
providers and other providers
understand patient needs and develop
plans to address them. For more
information on the Preferred Language
and Interpreter Services data elements,
we refer readers to the document titled
‘‘Proposed Specifications for SNF QRP
Measures and Standardized Patient
Assessment Data Elements,’’ available
on the website at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In an effort to standardize the
submission of language data among
IRFs, HHAs, SNFs and LTCHs, for the
purposes outlined in section
1899B(a)(1)(B) of the Act, while
minimizing the reporting burden, we are
proposing to adopt the Preferred
Language and Interpreter Services data
elements currently used on the MDS,
and describe above, as SPADEs with
respect to the Social Determinants of
Health category.
(c) Health Literacy
The Department of Health and Human
Services defines health literacy as ‘‘the
degree to which individuals have the
capacity to obtain, process, and
understand basic health information
and services needed to make
appropriate health decisions.’’ 170
Similar to language barriers, low health
literacy can interfere with
communication between the provider
and resident or patient and the ability
for residents and patients or their
caregivers to understand and follow
treatment plans, including medication
management. Poor health literacy is
linked to lower levels of knowledge
about health, worse health outcomes,
and the receipt of fewer preventive
services, but higher medical costs and
rates of emergency department use.171
170 U.S. Department of Health and Human
Services, Office of Disease Prevention and Health
Promotion. National action plan to improve health
literacy. Washington (DC): Author; 2010.
171 National Academies of Sciences, Engineering,
and Medicine. 2016. Accounting for social risk
factors in Medicare payment: Identifying social risk
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Health literacy is prioritized by
Healthy People 2020 as an SDOH.172
Healthy People 2020 is a long-term,
evidence-based effort led by the
Department of Health and Human
Services that aims to identify
nationwide health improvement
priorities and improve the health of all
Americans. Although not designated as
a social risk factor in NASEM’s 2016
report on accounting for social risk
factors in Medicare payment, the
NASEM noted that health literacy is
impacted by other social risk factors and
can affect access to care as well as
quality of care and health outcomes.173
Assessing for health literacy across PAC
settings would facilitate better care
coordination and discharge planning. A
significant challenge in assessing the
health literacy of individuals is avoiding
excessive burden on patients and
residents and health care providers. The
majority of existing, validated health
literacy assessment tools use multiple
screening items, generally with no fewer
than four, which would make them
burdensome if adopted in MDS, LCDS,
IRF–PAI, and OASIS.
The Single Item Literacy Screener
(SILS) question asks, ‘‘How often do you
need to have someone help you when
you read instructions, pamphlets, or
other written material from your doctor
or pharmacy?’’ Possible response
options are: (1) Never; (2) Rarely; (3)
Sometimes; (4) Often; and (5) Always.
The SILS question, which assesses
reading ability, (a primary component of
health literacy), tested reasonably well
against the 36 item Short Test of
Functional Health Literacy in Adults
(S–TOFHLA), a thoroughly vetted and
widely adopted health literacy test, in
assessing the likelihood of low health
literacy in an adult sample from primary
care practices participating in the
Vermont Diabetes Information
System.174 175 The S–TOFHLA is a more
factors. Washington, DC: The National Academies
Press.
172 Social Determinants of Health. Healthy People
2020. https://www.healthypeople.gov/2020/topicsobjectives/topic/social-determinants-of-health.
(February 2019).
173 U.S. Department of Health & Human Services,
Office of the Assistant Secretary for Planning and
Evaluation. Report to Congress: Social Risk Factors
and Performance Under Medicare’s Value-Based
Purchasing Programs. Available at https://
aspe.hhs.gov/pdf-report/report-congress-social-riskfactors-and-performance-under-medicares-valuebased-purchasing-programs. Washington, DC: 2016.
174 Morris, N.S., MacLean, C.D., Chew, L.D., &
Littenberg, B. (2006). The Single Item Literacy
Screener: evaluation of a brief instrument to
identify limited reading ability. BMC family
practice, 7, 21. doi:10.1186/1471–2296–7–21.
175 Brice, J.H., Foster, M.B., Principe, S., Moss, C.,
Shofer, F.S., Falk, R.J., Ferris, M.E., DeWalt, D.A.
(2013). Single-item or two-item literacy screener to
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complex assessment instrument
developed using actual hospital related
materials such as prescription bottle
labels and appointment slips, and often
considered the instrument of choice for
a detailed evaluation of health
literacy.176 Furthermore, the S–
TOFHLA instrument is proprietary and
subject to purchase for individual
entities or users.177 Given that SILS is
publicly available, shorter and easier to
administer than the full health literacy
screen, and research found that a
positive result on the SILS demonstrates
an increased likelihood that an
individual has low health literacy, we
are proposing to use the single-item
reading question for health literacy in
the standardized data collection across
PAC settings. We believe that use of this
data element will provide sufficient
information about the health literacy of
SNF residents to facilitate appropriate
care planning, care coordination, and
interoperable data exchange across PAC
settings.
In addition, we received feedback
during the December 13, 2018 SDOH
listening session on the importance of
recognizing health literacy as more than
understanding written materials and
filling out forms, as it is also important
to evaluate whether patients and
residents understand their conditions.
However, the NASEM recently
recommended that health care providers
implement health literacy universal
precautions instead of taking steps to
ensure care is provided at an
appropriate literacy level based on
individualized assessment of health
literacy.178 Given the dearth of Medicare
data on health literacy and gaps in
addressing health literacy in practice,
we recommend the addition of a health
literacy data element.
The proposed Health Literacy data
element is consistent with
considerations raised by NASEM and
other stakeholders and research on
health literacy, which demonstrates an
impact on health care use, cost, and
predict the S–TOFHLA among adult hemodialysis
patients. Patient Educ Couns. 94(1):71–5.
176 University of Miami, School of Nursing &
Health Studies, Center of Excellence for Health
Disparities Research. Test of Functional Health
Literacy in Adults (TOFHLA). (March 2019).
Available at https://elcentro.sonhs.miami.edu/
research/measures-library/tofhla/.
177 Nurss, J.R., Parker, R.M., Williams, M.V., &
Baker, D.W. David W. (2001). TOFHLA. Peppercorn
Books & Press. Available from: https://
www.peppercornbooks.com/catalog/
information.php?info_id=5.
178 Hudson, S., Rikard, R.V., Staiculescu, I. &
Edison, K. (2017). Improving health and the bottom
line: The case for health literacy. In Building the
case for health literacy: Proceedings of a workshop.
Washington, DC: The National Academies Press.
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outcomes.179 For more information on
the proposed Health Literacy data
element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Measures
and Standardized Patient Assessment
Data Elements,’’ available on the
website at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In an effort to standardize the
submission of health literacy data
among IRFs, HHAs, SNFs and LTCHs,
for the purposes outlined in section
1899B(a)(1)(B) of the Act, while
minimizing the reporting burden, we are
proposing to adopt the SILS question,
described above for the Health Literacy
data element, as SPADE under the
Social Determinants of Health Category.
We are proposing to add the Health
Literacy data element to the MDS.
(d) Transportation
Transportation barriers commonly
affect access to necessary health care,
causing missed appointments, delayed
care, and unfilled prescriptions, all of
which can have a negative impact on
health outcomes.180 Access to
transportation for ongoing health care
and medication access needs,
particularly for those with chronic
diseases, is essential to successful
chronic disease management. Adopting
a data element to collect and analyze
information regarding transportation
needs across PAC settings would
facilitate the connection to programs
that can address identified needs. We
are therefore proposing to adopt as
SPADE a single transportation data
element that is from the Protocol for
Responding to and Assessing Patients’
Assets, Risks, and Experiences
(PRAPARE) assessment tool and
currently part of the Accountable Health
Communities (AHC) Screening Tool.
The proposed Transportation data
element from the PRAPARE tool asks,
‘‘Has lack of transportation kept you
from medical appointments, meetings,
work, or from getting things needed for
daily living?’’ The three response
options are: (1) Yes, it has kept me from
medical appointments or from getting
my medications; (2) Yes, it has kept me
179 National Academies of Sciences, Engineering,
and Medicine. 2016. Accounting for Social Risk
Factors in Medicare Payment: Identifying Social
Risk Factors. Washington, DC: The National
Academies Press.
180 Syed, S.T., Gerber, B.S., and Sharp, L.K.
(2013). Traveling Towards Disease: Transportation
Barriers to Health Care Access. J Community
Health. 38(5): 976–993.
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from non-medical meetings,
appointments, work, or from getting
things that I need; and (3) No. The
patient or resident would be given the
option to select all responses that apply.
We are proposing to use the
transportation data element from the
PRAPARE Tool, with permission from
National Association of Community
Health Centers (NACHC), after
considering research on the importance
of addressing transportation needs as a
critical SDOH.181
The proposed data element is
responsive to research on the
importance of addressing transportation
needs as a critical SDOH and would
adopt the Transportation item from the
PRAPARE tool.182 This data element
comes from the national PRAPARE
social determinants of health
assessment protocol, developed and
owned by NACHC, in partnership with
the Association of Asian Pacific
Community Health Organization, the
Oregon Primary Care Association, and
the Institute for Alternative Futures.
Similarly the Transportation data
element used in the AHC Screening
Tool was adapted from the PRAPARE
tool. The AHC screening tool was
implemented by the Center for Medicare
and Medicaid Innovation’s AHC Model
and developed by a panel of
interdisciplinary experts that looked at
evidence-based ways to measure SDOH,
including transportation. While the
transportation access data element in
the AHC screening tool serves the same
purposes as our proposed SPADE
collection about transportation barriers,
the AHC tool has binary yes or no
response options that do not
differentiate between challenges for
medical versus non-medical
appointments and activities. We believe
that this is an important nuance for
informing PAC discharge planning to a
community setting, as transportation
needs for non-medical activities may
differ than for medical activities and
should be taken into account.183 We
believe that use of this data element will
provide sufficient information about
transportation barriers to medical and
non-medical care for SNF residents and
patients to facilitate appropriate
discharge planning and care
181 Health Research & Educational Trust. (2017,
November). Social determinants of health series:
Transportation and the role of hospitals. Chicago,
IL. Available at www.aha.org/
transportation.www.aha.org/transportation.
182 Health Research & Educational Trust. (2017,
November). Social determinants of health series:
Transportation and the role of hospitals. Chicago,
IL. Available at www.aha.org/transportation.
183 Northwestern University. (2017). PROMIS
Item Bank v. 1.0—Emotional Distress—Anger—
Short Form 1.
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coordination across PAC settings. As
such, we are proposing to adopt the
Transportation data element from
PRAPARE. More information about
development of the PRAPARE tool is
available on the website at https://
protect2.fireeye.com/url?k=7cb6eb4420e2f238-7cb6da7b-0cc47adc5fa21751cb986c8c2f8c&u=https://
www.nachc.org/prapare.
In addition, we received stakeholder
feedback during the December 13, 2018
SDOH listening session on the impact of
transportation barriers on unmet care
needs. While recognizing that there is
no consensus in the field about whether
providers should have responsibility for
resolving patient transportation needs,
discussion focused on the importance of
assessing transportation barriers to
facilitate connections with available
community resources.
Adding a Transportation data element
to the collection of SPADE would be an
important step to identifying and
addressing SDOH that impact health
outcomes and patient experience for
Medicare beneficiaries. For more
information on the Transportation data
element, we refer readers to the
document titled ‘‘Proposed
Specifications for SNF QRP Measures
and Standardized Patient Assessment
Data Elements,’’ available on the
website at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In an effort to standardize the
submission of transportation data
among IRFs, HHAs, SNFs and LTCHs,
for the purposes outlined in section
1899B(a)(1)(B) of the Act, while
minimizing the reporting burden, we are
proposing to adopt the Transportation
data element described above as SPADE
with respect to the Social Determinants
of Health category. If finalized as
proposed, we would add the
Transportation data element to the
MDS.
increase with age, is a risk factor for
physical and mental illness, and a
predictor of mortality.186 187 188 Postacute care providers are well-suited to
design and implement programs to
increase social engagement of patients
and residents, while also taking into
account individual needs and
preferences. Adopting a data element to
collect and analyze information about
social isolation in SNFs and across PAC
settings would facilitate the
identification of residents and patients
who are socially isolated and who may
benefit from engagement efforts.
We are proposing to adopt as SPADE
a single social isolation data element
that is currently part of the AHC
Screening Tool. The AHC item was
selected from the Patient-Reported
Outcomes Measurement Information
System (PROMIS®) Item Bank on
Emotional Distress and asks, ‘‘How
often do you feel lonely or isolated from
those around you?’’ The five response
options are: (1) Never; (2) Rarely; (3)
Sometimes; (4) Often; and (5)
Always.189 The AHC Screening Tool
was developed by a panel of
interdisciplinary experts that looked at
evidence-based ways to measure SDOH,
including social isolation. More
information about the AHC Screening
Tool is available on the website at
https://innovation.cms.gov/Files/
worksheets/ahcm-screeningtool.pdf.
In addition, we received stakeholder
feedback during the December 13, 2018
SDOH listening session on the value of
receiving information on social isolation
for purposes of care planning. Some
stakeholders also recommended
assessing social isolation as an SDOH as
opposed to social support.
The proposed Social Isolation data
element is consistent with NASEM
considerations about social isolation as
a function of social relationships that
impacts health outcomes and increases
mortality risk, as well as the current
work of a NASEM committee examining
how social isolation and loneliness
impact health outcomes in adults 50
(e) Social Isolation
connectedness-and-engagement-technology-longterm-and-post-acute-care-primer-and#1.1
186 Landeiro, F., Barrows, P., Nuttall Musson, E.,
Gray, A.M., and Leal, J. (2017). Reducing Social
Loneliness in Older People: A Systematic Review
Protocol. BMJ Open. 7(5): e013778.
187 Ong, A.D., Uchino, B.N., and Wethington, E.
(2016). Loneliness and Health in Older Adults: A
Mini-Review and Synthesis. Gerontology. 62:443–
449.
188 Leigh-Hunt, N., Bagguley, D., Bash, K., Turner,
V., Turnbull, S., Valtorta, N., and Caan, W. (2017).
An overview of systematic reviews on the public
health consequences of social isolation and
loneliness. Public Health. 152:157–171.
189 Northwestern University. (2017). PROMIS
Item Bank v. 1.0—Emotional Distress—Anger—
Short Form 1.
Distinct from loneliness, social
isolation refers to an actual or perceived
lack of contact with other people, such
as living alone or residing in a remote
area.184 185 Social isolation tends to
184 Tomaka, J., Thompson, S., and Palacios, R.
(2006). The Relation of Social Isolation, Loneliness,
and Social Support to Disease Outcomes Among the
Elderly. J of Aging and Health. 18(3): 359–384.
185 Social Connectedness and Engagement
Technology for Long-Term and Post-Acute Care: A
Primer and Provider Selection Guide. (2019).
Leading Age. Available at https://
www.leadingage.org/white-papers/social-
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years and older. We believe that adding
a Social Isolation data element would be
an important component of better
understanding resident and patient
complexity and the care goals of
residents and patients, thereby
facilitating care coordination and
continuity in care planning across PAC
settings. For more information on the
Social Isolation data element, we refer
readers to the document titled
‘‘Proposed Specifications for SNF QRP
Measures and Standardized Patient
Assessment Data Elements,’’ available
on the website at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.html.
In an effort to standardize the
submission of social isolation data
among IRFs, HHAs, SNFs and LTCHs,
for the purposes outlined in section
1899B(a)(1)(B) of the Act, while
minimizing the reporting burden, we are
proposing to adopt the Social Isolation
data element described above as SPADE
with respect to the proposed Social
Determinants of Health category. We are
proposing to add the Social Isolation
data element to the MDS.
We are soliciting comment on these
proposals.
8. Proposed Form, Manner, and Timing
of Data Submission Under the SNF QRP
a. Background
We refer readers to the regulatory text
at § 413.360(b) for information regarding
the current policies for reporting SNF
QRP data.
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b. Update to the CMS System for
Reporting Quality Measures and
Standardized Patient Assessment Data
and Associated Procedural Proposals
SNFs are currently required to submit
MDS data to CMS using the Quality
Improvement and Evaluation System
(QIES) Assessment and Submission
Processing (ASAP) system. We will be
migrating to a new internet Quality
Improvement and Evaluation System
(iQIES) that will enable real-time
upgrades over the next few years, and
we are proposing to designate that
system as the data submission system
for the SNF QRP once it becomes
available, but no later than October 1,
2021.
We are proposing to revise our
regulatory text at § 413.360(a) by
replacing ‘‘Certification and Survey
Provider Enhanced Reports (CASPER)’’
with ‘‘CMS designated data
submission’’. We are proposing to revise
our regulatory text at § 413.360(d)(1) by
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replacing the reference to the ‘‘Quality
Improvement Evaluation System (QIES)
Assessment Submission and Processing
(ASAP)’’ with ‘‘CMS designated data
submission’’ and § 413.360(d)(4) by
replacing the reference to ‘‘QIES ASAP’’
with ‘‘CMS designated data submission
system’’ effective October 1, 2019. In
addition we are proposing to notify the
public of any future changes to the CMS
designated system using subregulatory
mechanisms, such as website postings,
listserv messaging, and webinars.
We invite public comments on this
proposal.
c. Proposed Schedule for Reporting the
Transfer of Health Information Quality
Measures Beginning With the FY 2022
SNF QRP
As discussed in section VI.A.4. of this
proposed rule, we are proposing to
adopt the Transfer of Health Information
to Provider–Post-Acute Care (PAC) and
Transfer of Health Information to
Patient–Post-Acute Care (PAC) quality
measures beginning with the FY 2022
SNF QRP. We also are proposing that
SNFs would report the data on those
measures using the MDS. SNFs would
be required to collect data on both
measures for residents beginning with
October 1, 2020 discharges.
We refer readers to the FY 2018 SNF
PPS final rule (82 FR 36601 through
36603) for the data collection and
submission time frames that we
finalized for the SNF QRP.
We invite public comment on this
proposal.
d. Proposed Schedule for Reporting
Standardized Patient Assessment Data
Elements
As discussed in section VI.A.6. of this
proposed rule, we are proposing to
adopt SPADEs beginning with the FY
2022 SNF QRP. We are proposing that
SNFs would report the data using the
MDS. Similar to the proposed schedule
for reporting the Transfer of Health
Information to the Provider–Post-Acute
Care (PAC) and Transfer of Health
Information to the Patient–Post-Acute
Care (PAC) quality measures, SNFs
would be required to collect the
SPADEs for residents beginning with
October 1, 2020 admissions and
discharges. SNFs that submit data with
respect to admission for the Hearing,
Vision, Race, and Ethnicity SPADEs
would be considered to have submitted
data with respect to discharges. We refer
readers to the FY 2018 SNF PPS final
rule (82 FR 36601 through 36603) for
the data collection and submission time
frames that we finalized for the SNF
QRP.
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e. Proposed Data Reporting on Residents
for the SNF Quality Reporting Program
Beginning With the FY 2022 SNF QRP
We have received public input
suggesting that the quality measures
used in the SNF QRP should be
calculated using data collected from all
residents receiving SNF services,
regardless of the residents’ payer. This
input was provided to us via comments
requested about quality measure
development on the CMS Measures
Management System Blueprint
website,190 the TEPs held by our
measure development contractor,191 as
well as through comments we received
from stakeholders via our SNF QRP
mailbox, and feedback received from the
NQF-convened Measure Applications
Partnership (MAP) as part of their
recommendations on Coordination
Strategy for Post-Acute Care and LongTerm Care Performance
Measurement.192 Further, in the FY
2018 SNF PPS proposed rule (82 FR
21077), we sought input on expanding
the reporting of quality data to include
all residents, regardless of payer, so as
to ensure that the SNF QRP makes
publicly available information regarding
the quality of the services furnished to
the SNF population as a whole, rather
than just those residents who have
Medicare.
In response to that request for public
input, several commenters, including
MedPAC, submitted comments stating
that they would be supportive of an
effort to collect data specified under the
SNF QRP from all SNF residents
regardless of their payer. Benefits
highlighted by commenters included
that such data would serve to better
inform beneficiaries on the broader
quality of the entire SNF, as well as
more comprehensive quality
improvement efforts across payers.
MedPAC also highlighted that while the
data collection activity incurs some
190 Public Comment Summary Report Posting for
Transfer of Health Information and Care
Preferences. https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/
Post-Acute-Care-Quality-Initiatives/Downloads/
Development-of-Cross-Setting-Transfer-of-HealthInformation-Quality-Meas.pdf.
191 Technical Expert Panel Summary Report:
Development and Maintenance of Quality Measures
for Skilled Nursing Facility Quality Reporting
Program. April 2018. https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-Quality-Initiatives/
Downloads/TEP-Summary-Report_April-2018_
Development-and-Maintenance-of-QualityMeasures-for-SNF-QRP.pdf.
192 MAP Coordination Strategy for Post-Acute
Care and Long-Term Care Performance
Measurement. Feb 2012. https://
www.qualityforum.org/Publications/2012/02/MAP_
Coordination_Strategy_for_Post-Acute_Care_and_
Long-Term_Care_Performance_Measurement.aspx.
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cost, some providers currently assess all
residents routinely. For a more detailed
discussion we refer readers to the FY
2018 final rule (82 FR 36603 through
36604).
Further, we believe that the most
accurate representation of the quality
provided in SNFs to Medicare residents
would be best conveyed using data
collected via the MDS on all SNF
residents, regardless of payer.
Accordingly, we are proposing that
for purposes of meeting the
requirements of the SNF QRP, SNF
would be required to collect and submit
MDS data on all SNF residents
regardless of their payer. We believe
that this proposal will ensure that
Medicare residents are receiving the
same quality of SNF care as other
residents.
While we appreciate that collecting
quality data on all residents regardless
of payer may create additional burden,
we are aware that many SNFs currently
collect MDS data on all residents,
regardless of their payer, and that some
SNFs may consider it burdensome to
separate out Medicare beneficiaries from
other residents for purposes of
submitting the assessments to CMS.
We also note that collecting data on
all SNF residents, regardless of their
payer, would align our data collection
requirements under the SNF QRP with
the data collection requirements we
have adopted for the LTCH QRP and
Hospice QRP.
This proposal, if finalized, would be
effective beginning with the FY 2022
program year.
We invite public comment on this
proposal.
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9. Proposed Policies Regarding Public
Display of Measure Data for the SNF
QRP
Section 1899B(g) of the Act requires
the Secretary to establish procedures for
making the SNF QRP data available to
the public after ensuring that SNFs have
the opportunity to review their data
prior to public display. Measure data are
currently displayed on the Nursing
Home Compare website, an interactive
web tool that assists individuals by
providing information on SNF quality of
care. For more information on Nursing
Home Compare, we refer readers to the
website at https://www.medicare.gov/
nursinghomecompare/search.html. For
a more detailed discussion about our
policies regarding public display of SNF
QRP measure data and procedures for
the opportunity to review and correct
data and information, we refer readers
to the FY 2017 SNF PPS final rule (81
FR 52045 through 52048).
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In this proposed rule, we are
proposing to begin publicly displaying
data for the Drug Regimen Review
Conducted With Follow-Up for
Identified Issues—Post Acute Care
(PAC) Skilled Nursing Facility (SNF)
Quality Reporting Program (QRP)
measure beginning CY 2020 or as soon
as technically feasible. We finalized the
Drug Regimen Review Conducted With
Follow-Up for Identified Issues—Post
Acute Care (PAC) Skilled Nursing
Facility (SNF) Quality Reporting
Program (QRP) measure in the FY 2017
SNF PPS final rule (81 FR 52034
through 52039).
Data collection for this assessmentbased measure began with patients
admitted and discharged on or after
October 1, 2018. We are proposing to
display data based on four rolling
quarters, initially using discharges from
January 1, 2019 through December 31,
2019 (Quarter 1 2019 through Quarter 4
2019). To ensure the statistical
reliability of the data, we are proposing
that we would not publicly report a
SNF’s performance on the measure if
the SNF had fewer than 20 eligible cases
in any four consecutive rolling quarters.
SNFs that have fewer than 20 eligible
cases would be distinguished with a
footnote that states, ‘‘The number of
cases/resident stays is too small to
publicly report’’. We invite public
comment on our proposal.
B. Skilled Nursing Facility Value-Based
Purchasing Program (SNF VBP)
1. Background
Section 215(b) of the Protecting
Access to Medicare Act of 2014 (PAMA)
(Pub. L. 113–93) authorized the SNF
VBP Program (the ‘‘Program’’) by adding
section 1888(h) to the Act. As a
prerequisite to implementing the SNF
VBP Program, in the FY 2016 SNF PPS
final rule (80 FR 46409 through 46426),
we adopted an all-cause, all-condition
hospital readmission measure, as
required by section 1888(g)(1) of the Act
and discussed other policies to
implement the Program such as
performance standards, the performance
period and baseline period, and scoring.
In the FY 2017 SNF PPS final rule (81
FR 51986 through 52009), we adopted
an all-condition, risk-adjusted
potentially preventable hospital
readmission measure for SNFs, as
required by section 1888(g)(2) of the
Act, and adopted policies on
performance standards, performance
scoring, and sought comment on an
exchange function methodology to
translate SNF performance scores into
value-based incentive payments, among
other topics. In the FY 2018 SNF PPS
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17679
final rule (82 FR 36608 through 36623),
we adopted additional policies for the
Program, including an exchange
function methodology for disbursing
value-based incentive payments.
Additionally, in the FY 2019 SNF PPS
final rule (83 FR 39272 through 39282),
we adopted more policies for the
Program, including a scoring adjustment
for low-volume facilities.
The SNF VBP Program applies to
freestanding SNFs, SNFs affiliated with
acute care facilities, and all non-CAH
swing-bed rural hospitals. Section
1888(h)(1)(B) of the Act requires that the
SNF VBP Program apply to payments
for services furnished on or after
October 1, 2018. We believe the
implementation of the SNF VBP
Program is an important step towards
transforming how care is paid for,
moving increasingly towards rewarding
better value, outcomes, and innovations
instead of merely rewarding volume.
For additional background
information on the SNF VBP Program,
including an overview of the SNF VBP
Report to Congress and a summary of
the Program’s statutory requirements,
we refer readers to the FY 2016 SNF
PPS final rule (80 FR 46409 through
46410). We also refer readers to the FY
2017 SNF PPS final rule (81 FR 51986
through 52009) for discussion of the
policies that we adopted related to the
potentially preventable hospital
readmission measure, scoring, and other
topics. We refer readers to the FY 2018
SNF PPS final rule (82 FR 36608
through 36623) for discussions of the
policies that we adopted related to
value-based incentive payments, the
exchange function, and other topics.
Finally, we refer readers to the FY 2019
SNF PPS final rule (83 FR 39272
through 39282), where we adopted a
corrections policy for numerical values
of performance standards, a scoring
adjustment for low-volume facilities,
and addressed other topics.
2. Measures
a. Background
For background on the measures we
have adopted for the SNF VBP Program,
we refer readers to the FY 2016 SNF
PPS final rule (80 FR 46419), where we
finalized the Skilled Nursing Facility
30-Day All-Cause Readmission Measure
(SNFRM) (NQF #2510) that we are
currently using for the SNF VBP
Program. We also refer readers to the FY
2017 SNF PPS final rule (81 FR 51987
through 51995), where we finalized the
Skilled Nursing Facility 30-Day
Potentially Preventable Readmission
Measure (SNFPPR) that we will use for
the SNF VBP Program instead of the
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b. SNFPPR Update—Change of Measure
Name
In the FY 2017 SNF PPS final rule (81
FR 51987 to 51995), we adopted the
SNFPPR as the SNF all-condition riskadjusted potentially preventable
hospital readmission measure for the
SNF VBP Program to meet the
requirements in section 1888(g)(2) of the
Act. This claims-based measure assesses
the facility-level risk-standardized rate
of unplanned, potentially preventable
hospital readmissions for SNF patients
within 30 days of discharge from a prior
admission to an Inpatient Prospective
Payment System (IPPS) hospital, CAH,
or psychiatric hospital. However, we
have not yet transitioned the SNF VBP
Program to using the SNFPPR.
The SNFPPR is one of two potentially
preventable readmission measures
specified for use in the SNF setting. The
SNFPPR is specified for use for the SNF
VBP Program and a second measure, the
Potentially Preventable 30-Day PostDischarge Readmission Measure for
Skilled Nursing Facility Quality
Reporting Program, is specified for use
in the SNF QRP. While these two
measures are aligned in terms of
exclusion criteria and risk adjustment
approach, they differ in their
readmission windows. The SNFPPR
utilizes a 30-day post-hospital discharge
readmission window whereas the SNF
QRP potentially preventable
readmission measure utilizes a 30-day
post-SNF discharge readmission
window, consistent with the discharge
readmission window specified in other
measures we have developed with
respect to domains described in section
1899B of the Act, such as the Potentially
Preventable 30-Day Post-Discharge
Readmission Measure for Inpatient
Rehabilitation Facility QRP and the
Potentially Preventable 30-Day PostDischarge Readmission Measure for
Home Health QRP.
As described in the FY 2017 SNF PPS
final rule (81 FR 51992), our rationale
for having two different measures was
that the readmission window associated
with each measure assesses different
aspects of SNF care. The readmission
window for the SNFPPR measure was
developed to align with the SNFRM
which was previously adopted for the
SNF VBP Program. Both the SNFRM
and SNFPPR measure specifications,
including the readmission window,
were designed to harmonize with CMS’s
Hospital Wide All-Cause Unplanned
Readmission (HWR) measure used in
the Hospital IQR Program. The
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advantage of this window is that it
assesses readmissions both during the
SNF stay and post-SNF discharge for
most SNF patients, depending on the
SNF length of stay (LOS).
The readmission window used for the
SNF QRP measure aligns with the
readmission window used in other
readmission measures for post-acute
care (PAC) providers. The focus of this
post-PAC only discharge readmission
window is on assessing potentially
preventable hospital readmissions
during the 30 days after discharge from
the PAC provider.
While the SNFPPR and the SNF QRP
potentially preventable readmission
measures assess different aspects of SNF
care, we have received stakeholder
feedback that having two SNF
potentially preventable readmission
measures has caused confusion. To
minimize the confusion surrounding
these two different measures, we are
changing the name of the SNFPPR to
Skilled Nursing Facility Potentially
Preventable Readmissions after Hospital
Discharge. We believe this new measure
name will clearly differentiate the SNF
VBP potentially preventable
readmission measure from the SNF QRP
potentially preventable readmission
measure, thereby reducing stakeholder
confusion. We intend to submit the
SNFPPR measure, hereafter referred to
as the Skilled Nursing Facility
Potentially Preventable Readmissions
after Hospital Discharge measure, to the
National Quality Forum (NQF) for
endorsement review as soon as that is
feasible.
3. FY 2022 Performance Period and
Baseline Period and for Subsequent
Years
We refer readers to the FY 2016 SNF
PPS final rule (80 FR 46422) for a
discussion of our considerations for
determining performance periods under
the SNF VBP Program. Based on those
considerations, as well as public
comment, we adopted CY 2017 as the
performance period for the FY 2019
SNF VBP Program, with a
corresponding baseline period of CY
2015.
Additionally, in the FY 2018 SNF PPS
final rule (82 FR 36613 through 36614),
we adopted FY 2018 as the performance
period for the FY 2020 SNF VBP
Program, with a corresponding baseline
period of FY 2016. We refer readers to
that rule for a discussion of the need to
shift the Program’s measurement
periods from the calendar year to the
fiscal year. Finally, we refer readers to
the FY 2019 SNF PPS final rule (83 FR
39277 through 39278), where we
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adopted FY 2019 as the performance
period for the FY 2021 program year,
with a corresponding baseline period of
FY 2017. In that final rule, we also
adopted a policy where we would adopt
for each program year a performance
period that is the 1-year period
following the performance period for
the previous program year. We adopted
a similar policy for the baseline period,
where we stated that we would adopt
for each program year a baseline period
that is the 1-year period following the
baseline period for the previous year.
Under this policy, the performance
period for the FY 2022 program year
will be FY 2020, and the baseline period
will be FY 2018.
4. Performance Standards
a. Background
We refer readers to the FY 2017 SNF
PPS final rule (81 FR 51995 through
51998) for a summary of the statutory
provisions governing performance
standards under the SNF VBP Program
and our finalized performance standards
policy, as well as the numerical values
for the achievement threshold and
benchmark for the FY 2019 program
year. We also responded to public
comments on these policies in that final
rule.
We published the final numerical
values for the FY 2020 performance
standards in the FY 2018 SNF PPS final
rule (82 FR 36613) and published the
final numerical values for the FY 2021
performance standards in the FY 2019
SNF PPS final rule (83 FR 39276). We
also adopted a policy allowing us to
correct the numerical values of the
performance standards in the FY 2019
SNF PPS final rule (83 FR 39276
through 39277).
b. FY 2022 Performance Standards
As we discuss in this proposed rule,
we will adopt FY 2018 as the baseline
period for the FY 2022 program year
under our previously-adopted policy of
advancing the performance and baseline
period for each program year
automatically.
Based on the baseline period for the
FY 2022 program year, we are
estimating that the performance
standards would have the numerical
values noted in Table 14. We note that
these values represent estimates based
on the most recently-available data, and
we will update the numerical values in
the FY 2020 SNF PPS final rule.
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TABLE 14—ESTIMATED FY 2022 SNF VBP PROGRAM PERFORMANCE STANDARDS
Measure ID
Measure description
Achievement
threshold
Benchmark
SNFRM ........................................................
SNF 30-Day All-Cause Readmission Measure (NQF #2510) .......
0.79476
0.83212
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5. SNF VBP Performance Scoring
We refer readers to the FY 2017 SNF
PPS final rule (81 FR 52000 through
52005) for a detailed discussion of the
scoring methodology that we have
finalized for the Program, along with
responses to public comments on our
policies and examples of scoring
calculations. We also refer readers to the
FY 2018 SNF PPS final rule (82 FR
36614 through 36616) for discussion of
the rounding policy we adopted, our
request for comments on SNFs with zero
readmissions, and our request for
comments on a potential extraordinary
circumstances exception policy.
We also refer readers to the FY 2019
SNF PPS final rule (83 FR 39278
through 39281), where we adopted (1) A
scoring policy for SNFs without
sufficient baseline period data, (2) a
scoring adjustment for low-volume
SNFs, and (3) an extraordinary
circumstances exception policy.
We are not proposing any updates to
SNF VBP scoring policies in this
proposed rule.
6. SNF Value-Based Incentive Payments
We refer readers to the FY 2018 SNF
PPS final rule (82 FR 36616 through
36621) for discussion of the exchange
function methodology that we have
adopted for the Program, as well as the
specific form of the exchange function
(logistic, or S-shaped curve) that we
finalized, and the payback percentage of
60 percent. We adopted these policies
for FY 2019 and subsequent fiscal years.
We also discussed the process that we
undertake for reducing SNFs’ adjusted
Federal per diem rates under the
Medicare SNF PPS and awarding valuebased incentive payments in the FY
2019 SNF PPS final rule (83 FR 39281
through 39282).
For estimates of FY 2020 SNF VBP
Program incentive payment multipliers,
we encourage SNFs to refer to FY 2019
SNF VBP Program performance
information, available at: https://
data.medicare.gov/Nursing-HomeCompare/SNF-VBP-Facility-LevelDataset/284v-j9fz. Our analysis of
historical SNF VBP data shows that the
Program’s incentive payment
multipliers appear to be relatively
consistent over time. As a result, we
believe that the FY 2019 payment
results represent our best estimate of FY
2020 performance at this time.
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We are not proposing any updates to
SNF VBP payment policies in this
proposed rule. However, for the reader’s
information, we modeled the estimated
impacts of the low-volume adjustment
policy that we established in the FY
2019 SNF PPS final rule for FY 2020
and estimate that the application of the
low-volume adjustment policy to the FY
2020 program year would redistribute
an additional $8.1 million to these lowvolume SNFs for that program year.
This would increase the 60 percent
payback percentage for FY 2020 by
approximately 1.51 percent, resulting in
a payback percentage for FY 2020 that
is 61.51 percent of the estimated $534.1
million in withheld funds for that fiscal
year.
7. Public Reporting on the Nursing
Home Compare Website
a. Background
Section 1888(g)(6) of the Act requires
the Secretary to establish procedures to
make SNFs’ performance information on
SNF VBP Program measures available to
the public on the Nursing Home
Compare website or a successor, and to
provide SNFs an opportunity to review
and submit corrections to that
information prior to its publication. We
began publishing SNFs’ performance
information on the SNFRM in
accordance with this directive and the
statutory deadline of October 1, 2017.
Additionally, section 1888(h)(9)(A) of
the Act requires the Secretary to make
available to the public certain
information on SNFs’ performance
under the SNF VBP Program, including
SNF Performance Scores and their
ranking. Section 1888(h)(9)(B) of the Act
requires the Secretary to post aggregate
information on the Program, including
the range of SNF Performance Scores
and the number of SNFs receiving
value-based incentive payments, and
the range and total amount of those
payments.
In the FY 2017 SNF PPS final rule (81
FR 52009), we discussed the statutory
requirements governing public reporting
of SNFs’ performance information under
the SNF VBP Program. We also sought
and responded to public comments on
issues that we should consider when
posting performance information on
Nursing Home Compare or a successor
website. In the FY 2018 SNF PPS final
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rule (82 FR 36622 through 36623), we
finalized our policy to publish SNF
measure performance information under
the SNF VBP Program on Nursing Home
Compare after SNFs have had an
opportunity to review and submit
corrections to that information under
the two-phase Review and Corrections
process that we adopted in the FY 2017
SNF PPS final rule (81 FR 52007
through 52009) and for which we
adopted additional requirements in the
FY 2018 SNF PPS final rule. In the FY
2018 SNF PPS final rule, we also
adopted requirements to rank SNFs and
adopted data elements that we will
include in the ranking to provide
consumers and stakeholders with the
necessary information to evaluate SNFs’
performance under the Program.
b. Public Reporting of SNF Performance
Scores, Achievement and Improvement
Scores, and Ranking
As we have considered issues
associated with public reporting of
SNFs’ performance information on the
Nursing Home Compare website, we
have identified an issue that we believe
warrants additional discussion.
Specifically, we are concerned that the
performance information available for
display for a specific SNF may, as a
result of the application of two policies
we have finalized for the Program, be
confusing to the public. Specifically,
SNFs with fewer than 25 eligible stays
during the baseline period for a fiscal
year will only be scored on achievement
and will not have improvement
information available for display. In
addition, a SNF with fewer than 25
eligible stays during a performance
period will receive an assigned SNF
performance score for that Program year
that results in a value-based incentive
payment amount equal to the adjusted
federal per diem rate that the SNF
would have received for the fiscal year
in the absence of the Program.
In these cases, we do not believe it
would be appropriate to suppress the
SNF’s information entirely given the
statutory requirements in section
1888(h)(9)(A) of the Act to publicly
report SNF-specific information, but we
are concerned about publishing
performance information that is not
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based on enough data to convey a
complete and reliable picture of a SNF’s
performance for the Program year.
Based on these considerations, we
propose to suppress the SNF
information available to display as
follows: (1) If a SNF has fewer than 25
eligible stays during the baseline period
for a Program year, we would not
display the baseline RSRR or
improvement score, though we would
still display the performance period
RSRR, achievement score and total
performance score if the SNF had
sufficient data during the performance
period; (2) if a SNF has fewer than 25
eligible stays during the performance
period for a Program year and receives
an assigned SNF performance score as a
result, we would report the assigned
SNF performance score and we would
not display the performance period
RSRR, the achievement score or
improvement score; and (3) if a SNF has
zero eligible cases during the
performance period for a Program year,
we would not display any information
for that SNF. Based on historical data,
we estimate that approximately 16
percent of SNFs will have fewer than 25
eligible stays during the performance
period and similarly approximately 16
percent of SNFs will have fewer than 25
stays in the baseline period for FY 2020.
We believe that this policy will
ensure that we publish as much
information as possible about the SNF
VBP Program’s performance
assessments while ensuring that the
published information is reliable and
based on a sufficient quantity of
information. We further believe that this
policy will provide stakeholders with
meaningful information about SNFs’
performance under the Program.
We welcome public comment on this
proposal.
8. Update to Phase One Review and
Correction Deadline
In the FY 2017 SNF PPS final rule (81
FR 52007 through 52009), we adopted a
two-phase review and corrections
process for SNFs’ quality measure data
that will be made public under section
1888(g)(6) of the Act and SNF
performance information that will be
made public under section 1888(h)(9) of
the Act. We explained that we would
accept corrections to the quality
measure data used to calculate the
measure rates that are included in any
SNF’s quarterly confidential feedback
report, and that we would provide SNFs
with an annual confidential feedback
report containing the performance
information that will be made public.
We detailed the process for requesting
Phase One corrections and finalized a
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policy whereby we would accept Phase
One corrections to any quarterly report
provided during a calendar year until
the following March 31.
However, as we have continued
implementation of the SNF VBP
Program, we have reconsidered what
deadline would be appropriate for the
Phase One correction process. Our
experience managing the 2019 SNF VBP
Program has shown that fewer than 10
facilities submitted sufficient correction
information under the Phase One
correction process after October 1, 2018
and before March 31, 2019.
Additionally, we are concerned about
the effects of the March 31 deadline on
value-based incentive payment
calculations since the deadline is
currently 6 months after payment
incentives begin. For example,
performance score reports for the FY
2019 SNF VBP Program were provided
in August 2018 and incentive payments
for that FY were made beginning with
services provided on October 1, 2018,
but SNFs still had until March 31, 2019
to make a correction. We believe that
the March 31 deadline also creates
uncertainty for SNFs because, as shown
above in the timeline that applied to the
FY 2019 Program, their payment
incentives could potentially change 6
months after they take effect. If we
approve a correction request, we then
need to reprocess several months of
claims for the SNF in question and
potentially need to adjust the exchange
function for the fiscal year depending
on the scope of the correction and its
effects on the payback percentage pool
for the fiscal year. We do not believe
these outcomes are beneficial to the
Program or to SNFs that would have less
predictability about their incentive
payment percentages for the fiscal year.
We believe that the lack of predictability
for SNF payment percentages might
adversely impact SNF financial
planning because payment amounts
would not be set for all SNFs until after
the March 31 deadline.
We believe that we can mitigate this
uncertainty by adopting a 30-day
deadline for Phase One correction
requests, and note that this proposal
would align the Phase One review and
correction process with the Phase Two
process. Under current operations, we
issue a report in June that contains all
of the underlying claim information
used to calculate the measure rate for
the program year, as well as the measure
rate itself. We are proposing that SNFs
would have 30 days from the date that
we issue that report to review the claims
and measure rate information and to
submit to us a correction request if the
SNF believes that any of that
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information is inaccurate. We note that
this proposal would not preclude a SNF
from submitting a correction request for
any claims for which it discovers an
error prior to receiving the June report.
However, the 30 day review and
correction period would commence on
the day that we issue the June report,
and a SNF would not be able to request
that we correct any underlying claims or
its measure rate after the conclusion of
that 30 day period.
We are proposing this deadline in lieu
of the current March 31 deadline for
Phase One corrections. We note that we
initially proposed to adopt a 30-day
deadline for Phase One corrections in
the FY 2017 SNF PPS proposed rule (81
FR 24255), though we finalized a
deadline of March 31 following the
calendar year in which we provide the
report. We adopted that extended
deadline to balance our desire to ensure
that measure data are sufficiently
accurate with SNFs’ need for sufficient
information with which to evaluate
those reports, as well as to provide SNFs
with more time to review each quarter’s
data. In addition, we encouraged SNFs
to review the quarterly reports provided
with stay-level information and make
any corrections to claims before the
proposed deadline. However, for the
reasons discussed above, we now
believe that a 30-day timeframe is
sufficient for SNFs to determine if there
were errors in its measure calculation by
CMS or its contractor.
We believe that this policy will
ensure that the underlying claims data
that we use to calculate quality measure
performance for the SNF VBP Program
will be finalized prior to their use in
scoring and payment calculations. We
believe that this policy will also ensure
that any corrections submitted under
Phase One do not result in changes to
quality measure data months after
incentive payment calculations, which
will also avoid changes to the exchange
function, and as a result, changes to
other SNFs’ value-based incentive
payment percentages for a fiscal year
because of data errors for any SNFs. Our
experience managing the 2019 SNF VBP
Program indicates that very few SNFs
would be adversely impacted by the
earlier deadline. We also seek to provide
SNFs with earlier final annual payment
percentage information for their
financial planning purposes.
We welcome public comments on this
proposal.
VII. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501 et seq.),
we are required to publish a 60-day
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notice in the Federal Register and
solicit public comment before a
‘‘collection of information’’ requirement
is submitted to the Office of
Management and Budget (OMB) for
review and approval. For the purposes
of the PRA and this section of the
preamble, collection of information is
defined under 5 CFR 1320.3(c) of the
PRA’s implementing regulations.
To fairly evaluate whether an
information collection should be
approved by OMB, PRA section
3506(c)(2)(A) requires that we solicit
comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our burden
estimates.
• The quality, utility, and clarity of
the information to be collected.
• Our effort to minimize the
information collection burden on the
affected public, including the use of
automated collection techniques.
We are soliciting public comment on
each of the section 3506(c)(2)(A)required issues for the following
information collection requirements
(ICRs).
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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 (https://www.bls.gov/
oes/current/oes_nat.htm). In this regard,
Table 15 presents the mean hourly
wage, the cost of fringe benefits and
overhead (calculated at 100 percent of
the mean hourly wage), and the adjusted
hourly wage. The adjusted wage is used
to derive this section’s average cost
estimates.
TABLE 15—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES
Occupation
code
Occupation title
Health Information Technician .........................................................................
Registered Nurse .............................................................................................
As indicated, we are adjusting our
employee hourly wage estimates by a
factor of 100 percent. This is necessarily
a rough adjustment, both because fringe
benefits and overhead costs vary
significantly from employer to
employer, and because methods of
estimating these costs vary widely from
study to study. Nonetheless, we believe
that doubling the mean hourly wage to
help estimate the total cost is a
reasonably accurate estimation method.
B. Proposed Information Collection
Requirements (ICRs)
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1. ICRs Regarding the SNF Quality
Reporting Program (QRP)
The following proposed changes will
be submitted to OMB for approval under
control number 0938–1140 (CMS–
10387). The changes would not impose
any new or revised burden. Subject to
renewal, the control number is currently
set to expire on February 28, 2022. It
was last approved on February 12, 2019,
and remains active.
The Minimum Data Set (MDS) is part
of the process for the clinical
assessment of all SNF residents and
serves multiple purposes. It is used as
a data collection tool for SNFs in the
PPS to inform the Patient Driven
Payment Model (PDPM) for the purpose
of reimbursement, for the SNF QRP for
the purpose of monitoring the quality of
care in SNFs, and under the
requirements of Omnibus Budget
Reconciliation Act (OBRA) 1987 for the
collection of data for the purposes of
comprehensive resident assessment,
quality and care planning for SNF
residents.
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29–2071
29–1141
Under sections 4204(b) and 4214(d) of
OBRA 1987, requirements related to the
submission and retention of resident
assessment data are not subject to the
PRA. The MDS assessments that are
used to inform payment consist of the
PPS 5-day assessment, the PPS
discharge assessment, and the optional
Interim Payment Assessment (IPA). The
requirements necessary to administer
the payment rate methodology
described in 42 CFR 413.337 are subject
to the PRA. Thus, the PPS 5-day, PPS
discharge, and IPA assessments are
subject to the PRA and are active under
OMB control number 0938–1140.193 For
the readers’ convenience, the active
burden estimates are summarized below
in Table 16. It is important to note that
SNFs currently collect and report data
for the SNF QRP through the PPS 5-day
and PPS discharge assessments, which
are the same assessments used in the
PDPM. The IPA is an optional
assessment for the PDPM and is not
used for the SNF QRP.
Section 2(a) of the IMPACT Act
amended the statute by adding section
1899B to the Act, which requires,
among other things, SNFs to report
standardized patient assessment data,
data on quality measures, and data on
resource use and other measures. Under
section 1899B(m) of the Act,
modifications to the SNF assessment
instrument, the MDS, required to
achieve standardization of patient
assessment data are exempt from PRA
requirements. However, if the data
elements for quality measures and
193 Available at https://www.reginfo.gov/public/
do/PRAViewDocument?ref_nbr=201809-0938-009.
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Mean
hourly wage
($/hr)
20.59
35.36
Fringe benefits
and overhead
($/hr)
20.59
35.36
Adjusted
hourly wage
($/hr)
41.18
70.72
standardized patient assessment data
are finalized as proposed, then we
believe that we will have met the
requirements for standardization of
patient assessment data. Therefore, the
exemption of the SNF QRP from the
PRA is no longer applicable such that
the SNF QRP requirements and burden
will be submitted to OMB for review
and approval. The active ICR serves as
the basis for which we now address the
previously exempt requirements and
burden.
Under our active information
collection, only the PPS 5-day and PPS
discharge assessments used in the
PDPM are also used as the assessments
for collecting quality measure and
standardized patient assessment data
under the SNF QRP. Our active burden
sets out 51 minutes (0.85 hours) per PPS
5-day assessment and 51 minutes per
PPS discharge assessment. Consistent
with the FY 2019 SNF PPS final rule
(August 8, 2018; 83 FR 39283) we
continue to use the OMRA assessment
(with 272 items) to estimate the amount
of time to complete a PPS assessment.
This is also consistent with our active
information collection. In sections
VI.A.4 and VI.A.7 of this rule, we
propose to add 60.5 items across the
PPS 5-day and PPS discharge
assessments. Given that the PPS OMRA
item set has 272 items (as compared to
the PPS discharge assessment with 143
items) that are approved under our
active collection, the added items, while
increasing burden for each of the
assessments, have no impact on our
currently approved burden estimates
since the active collection uses the PPS
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OMRA item set as a proxy for all
assessments. Below, however, we are
restating such burden as a courtesy to
interested parties.
When calculating the burden for each
assessment, we estimate it will take 40
minutes (0.6667 hours) at $70.72/hr for
an RN to collect the information
necessary for preparing the assessment,
10 minutes (0.1667 hours) at $55.95/hr
(the average hourly wage for RN
($70.72/hr) and health information
technician ($41.18/hr)) for staff to code
the responses, and 1 minute (0.0167
hours) at $41.18/hr for a health
information technician to transmit the
results. In total, we estimate that it will
take 51 minutes (0.85 hours) to
complete a single PPS assessment.
Based on the adjusted hourly wages for
the noted staff, we estimate that it will
cost $57.17 [($70.72/hr × 0.6667 hr) +
($55.95/hr × 0.1667 hr) + ($41.18/hr ×
0.0167 hr)] to prepare, code, and
transmit each PPS assessment.
Based on our most current data, there
are 15,471 Medicare Part A SNFs. Based
on FY 2017 data, we estimate that
2,406,401 5-day PPS assessments will be
completed and submitted by Part A
SNFs each year under the PDPM and
SNF QRP. We used the same number of
assessments (2,406,401) as a proxy for
the number of PPS discharge
assessments that would be completed
and submitted each year, since all
residents who require a 5-day PPS
assessment will also require a discharge
assessment under the PDPM and SNF
QRP. We use the Significant Change in
Status Assessment (SCSA) as a proxy to
estimate the number of IPAs as the
criteria for completing an SCSA is
similar to that for the IPA. Based on FY
2017 data, 92,240 IPAs would be
completed per year under the PDPM.
The total number of PPS 5-day
assessments, PPS discharge
assessments, and IPAs that would be
completed across all facilities is
4,905,042 assessments (2,406,401 +
2,406,401 + 92,240, respectively). The
total estimated time for all assessments
across all facilities is 4,169,286 hours
per year (4,905,042 assessments × 0.85
hours/assessment). For all assessments
across all facilities, we estimate a
burden of $280,421,251 (4,905,042
assessments × $57.17/assessment).
Given that our proposal to add 60.5
items across the PPS 5-day and PPS
discharge assessments is accounted for
by using the OMRA assessment as a
proxy for all assessments, and given that
our estimate for the number of Medicare
Part A SNFs and for the number PPS 5-
day and PPS discharge assessments
completed and submitted by Part A
SNFs each year remains unchanged, we
are not proposing to revise or adjust any
of our active burden estimates. In this
regard, we will be submitting a revised
information collection request to OMB
to account for the added items.
In section VI.A.8.b. of this proposed
rule, there are no burden implications
associated with updating the data
submission system to the iQIES for the
SNF QRP once it becomes available, but
no later than October 1, 2021. This
designation is a replacement of the
existing QIES ASAP data submission
system and imposes no additional
requirements or burden on the part of
SNFs.
2. ICRs Regarding the SNF VBP Program
We are not proposing to remove, add,
or revise any of our SNF VBP measurerelated requirements or burden. Because
this proposed rule would not impose
any new or revised SNF VBP collection
of information requirements or burden,
the rule contains no SNF–VBP related
collections of information that would be
subject to OMB approval under the
authority of the PRA.
C. Summary of Proposed Requirements
and Annual Burden Estimates
TABLE 16—SUMMARY OF PROPOSED REQUIREMENTS AND ANNUAL BURDEN ESTIMATES UNDER OMB CONTROL NUMBER
0938–1140
[CMS–10387]
Program changes
Number
respondents
Total
responses
Time per
response
(hr)
Total time
(hr)
Labor
cost
per hour
($/hr)
Total cost
($)
Active Burden .......................
Proposed Changes ...............
15,471
0
317.04
0
4,905,042
0
0.85
0
4,169,286
0
varies ....
0 ............
280,421,251
0
Total ...............................
15,471
317.04
4,905,042
0.85
4,169,286
varies ....
280,421,251
D. Submission of PRA-Related
Comments
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Responses
(per
respondent)
We have submitted a copy of this
proposed rule 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 our
proposed information collection
requirements/burden. If you wish to
comment, please identify the rule
(CMS–1718–P) along with the
information collection’s CMS ID number
(CMS–10387) and OMB control number
(0938–1140).
To obtain copies of the supporting
statement and any applicable
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supplementary materials, you may make
your request using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB control
number, and CMS document identifier
to Paperwork@cms.hhs.gov.
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.
VIII. Response to Comments
Because of the large number of public
comments we normally receive on
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Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
IX. Economic Analyses
A. Regulatory Impact Analysis
1. Statement of Need
This proposed rule would update the
FY 2019 SNF prospective payment rates
as required under section 1888(e)(4)(E)
of the Act. It also responds to section
1888(e)(4)(H) of the Act, which requires
the Secretary to provide for publication
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in the Federal Register before the
August 1 that precedes the start of each
FY, the unadjusted federal per diem
rates, the case-mix classification system,
and the factors to be applied in making
the area wage adjustment. As these
statutory provisions prescribe a detailed
methodology for calculating and
disseminating payment rates under the
SNF PPS, we do not have the discretion
to adopt an alternative approach on
these issues.
2. Introduction
We have examined the impacts of this
proposed rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993),
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011), the Regulatory
Flexibility Act (RFA, September 19,
1980, Pub. L. 96–354), section 1102(b) of
the Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA,
March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999), the Congressional
Review Act (5 U.S.C. 804(2)), and
Executive Order 13771 on Reducing
Regulation and Controlling Regulatory
Costs (January 30, 2017).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This rule
has been designated an economically
significant rule, under section 3(f)(1) of
Executive Order 12866. Accordingly, we
have prepared a regulatory impact
analysis (RIA) as further discussed
below. Also, the rule has been reviewed
by OMB.
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3. Overall Impacts
This proposed rule sets forth updates
of the SNF PPS rates contained in the
SNF PPS final rule for FY 2019 (83 FR
39162). We estimate that the aggregate
impact will be an increase of
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approximately $887 million in
payments to SNFs in FY 2020, resulting
from the SNF market basket update to
the payment rates. We note that these
impact numbers do not incorporate the
SNF VBP reductions that we estimate
will total $527.4 million in FY 2020. We
would note that events may occur to
limit the scope or accuracy of our
impact analysis, as this analysis is
future-oriented, and thus, very
susceptible to forecasting errors due to
events that may occur within the
assessed impact time period.
In accordance with sections
1888(e)(4)(E) and 1888(e)(5) of the Act,
we update the FY 2019 payment rates
by a factor equal to the market basket
index percentage change adjusted by the
MFP adjustment to determine the
payment rates for FY 2020. The impact
to Medicare is included in the total
column of Table 17. In updating the
SNF PPS rates for FY 2020, we made a
number of standard annual revisions
and clarifications mentioned elsewhere
in this proposed rule (for example, the
update to the wage and market basket
indexes used for adjusting the federal
rates).
The annual update set forth in this
proposed rule applies to SNF PPS
payments in FY 2020. Accordingly, the
analysis of the impact of the annual
update that follows only describes the
impact of this single year. Furthermore,
in accordance with the requirements of
the Act, we will publish a rule or notice
for each subsequent FY that will
provide for an update to the payment
rates and include an associated impact
analysis.
4. Detailed Economic Analysis
The FY 2020 SNF PPS payment
impacts appear in Table 17. Using the
most recently available data, in this case
FY 2018, we apply the current FY 2019
wage index and labor-related share
value to the number of payment days to
simulate FY 2019 payments. Then,
using the same FY 2018 data, we apply
the proposed FY 2020 wage index and
labor-related share value to simulate FY
2020 payments. We tabulate the
resulting payments according to the
classifications in Table 17 (for example,
facility type, geographic region, facility
ownership), and compare the simulated
FY 2019 payments to the simulated FY
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17685
2020 payments to determine the overall
impact. The breakdown of the various
categories of data Table 17 follows:
• The first column shows the
breakdown of all SNFs by urban or rural
status, hospital-based or freestanding
status, census region, and ownership.
• The first row of figures describes
the estimated effects of the various
changes on all facilities. The next six
rows show the effects on facilities split
by hospital-based, freestanding, urban,
and rural categories. The next nineteen
rows show the effects on facilities by
urban versus rural status by census
region. The last three rows show the
effects on facilities by ownership (that
is, government, profit, and non-profit
status).
• The second column shows the
number of facilities in the impact
database.
• The third column shows the effect
of the transition to PDPM. This
represents the effect on providers,
assuming no changes in behavior or
case-mix, from changing the case-mix
classification model used to classify
patients in a Medicare Part A SNF stay.
The total impact of this change is 0.0
percent; however, there are
distributional effects of this change.
• The fourth column shows the effect
of the annual update to the wage index.
This represents the effect of using the
most recent wage data available. The
total impact of this change is 0.0
percent; however, there are
distributional effects of the change.
• The fifth column shows the effect of
all of the changes on the FY 2020
payments. The update of 2.5 percent is
constant for all providers and, though
not shown individually, is included in
the total column. It is projected that
aggregate payments will increase by 2.5
percent, assuming facilities do not
change their care delivery and billing
practices in response.
As illustrated in Table 17, the
combined effects of all of the changes
vary by specific types of providers and
by location. For example, due to
changes in this proposed rule, providers
in the urban Pacific region would
experience a 1.7 percent increase in FY
2020 total payments.
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5. Estimated Impacts for the Skilled
Nursing Facility (SNF) Quality
Reporting Program (QRP)
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Estimated impacts for the SNF QRP
are based on analysis discussed in
section VII.B.1. of this proposed rule.
The proposed SNF QRP requirements
add no additional burden to the active
OMB #0938–1140 (CMS–10387).
6. Impacts for the SNF VBP Program
Estimated impacts of the FY 2020
SNF VBP Program are based on
historical data and appear in Table 18.
We modeled SNF performance in the
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Program using SNFRM data from CY
2015 as the baseline period and CY 2017
as the performance period.
Additionally, we modeled a logistic
exchange function with a payback
percentage of 60 percent, as we finalized
in the FY 2018 SNF PPS final rule (82
FR 36619 through 36621), though we
note that the 60 percent payback
percentage for FY 2020 will adjust to
account for the low-volume scoring
adjustment that we adopted in the FY
2019 SNF PPS final rule (83 FR 39278
through 39280). Based on the 60 percent
payback percentage (as modified by the
low-income scoring adjustment), we
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estimate that we will redistribute
approximately $320.4 million in valuebased incentive payments to SNFs in FY
2020, which means that the SNF VBP
Program is estimated to result in
approximately $213.6 million in savings
to the Medicare Program in FY 2020. We
refer readers to the FY 2019 SNF PPS
final rule (83 FR 39278 through 39280)
for additional information about
payment adjustments for low-volume
SNFs in the SNF VBP Program.
Our detailed analysis of the impacts
of the FY 2020 SNF VBP Program
follows in Table 18.
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7. Alternatives Considered
As described in this section, we
estimated that the aggregate impact for
FY 2020 under the SNF PPS will be an
increase of approximately $887 million
in payments to SNFs, resulting from the
SNF market basket update to the
payment rates.
Section 1888(e) of the Act establishes
the SNF PPS for the payment of
Medicare SNF services for cost reporting
periods beginning on or after July 1,
1998. This section of the statute
prescribes a detailed formula for
calculating base payment rates under
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the SNF PPS, and does not provide for
the use of any alternative methodology.
It specifies that the base year cost data
to be used for computing the SNF PPS
payment rates must be from FY 1995
(October 1, 1994, through September 30,
1995). In accordance with the statute,
we also incorporated a number of
elements into the SNF PPS (for example,
case-mix classification methodology, a
market basket index, a wage index, and
the urban and rural distinction used in
the development or adjustment of the
federal rates). Further, section
1888(e)(4)(H) of the Act specifically
requires us to disseminate the payment
rates for each new FY through the
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Federal Register, and to do so before the
August 1 that precedes the start of the
new FY; accordingly, we are not
pursuing alternatives for this process.
8. Accounting Statement
As required by OMB Circular A–4
(available online at https://
obamawhitehouse.archives.gov/omb/
circulars_a004_a-4/), in Tables 19 and
20, we have prepared an accounting
statement showing the classification of
the expenditures associated with the
provisions of this proposed rule for FY
2020. Tables 17 and 19 provide our best
estimate of the possible changes in
Medicare payments under the SNF PPS
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as a result of the policies in this
proposed rule, based on the data for
15,078 SNFs in our database. Tables 18
and 20 provide our best estimate of the
possible changes in Medicare payments
under the SNF VBP as a result of the
policies in this proposed rule.
TABLE 19—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES, FROM THE 2019 SNF PPS FISCAL
YEAR TO THE 2020 SNF PPS FISCAL YEAR
Category
Transfers
Annualized Monetized Transfers .......................................................................................
From Whom To Whom? ....................................................................................................
$887 million.*
Federal Government to SNF Medicare Providers.
* The net increase of $887 million in transfer payments is a result of the market basket increase of $887 million.
TABLE 20—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES FOR THE FY 2020 SNF VBP
PROGRAM
Category
Transfers
Annualized Monetized Transfers .......................................................................................
From Whom To Whom? ....................................................................................................
$320.4 million.*
Federal Government to SNF Medicare Providers.
* This estimate does not include the two percent reduction to SNFs’ Medicare payments (estimated to be $527.4 million) required by statute.
9. Conclusion
This proposed rule sets forth updates
of the SNF PPS rates contained in the
SNF PPS final rule for FY 2019 (83 FR
39162). Based on the above, we estimate
that the overall payments for SNFs
under the SNF PPS in FY 2020 are
projected to increase by approximately
$887 million, or 2.5 percent, compared
with those in FY 2019. We estimate that
in FY 2020 under PDPM, SNFs in urban
and rural areas will experience, on
average, a 1.8 percent increase and 6.4
percent increase, respectively, in
estimated payments compared with FY
2019. Providers in the urban Outlying
region will experience the largest
estimated increase in payments of
approximately 61.3 percent. Providers
in the urban Middle Atlantic region will
experience the largest estimated
decrease in payments of 0.8 percent.
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B. Regulatory Flexibility Act Analysis
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses, nonprofit organizations, and small
governmental jurisdictions. Most SNFs
and most other providers and suppliers
are small entities, either by reason of
their non-profit status or by having
revenues of $27.5 million or less in any
1 year. We utilized the revenues of
individual SNF providers (from recent
Medicare Cost Reports) to classify a
small business, and not the revenue of
a larger firm with which they may be
affiliated. As a result, for the purposes
of the RFA, we estimate that almost all
SNFs are small entities as that term is
used in the RFA, according to the Small
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Business Administration’s latest size
standards (NAICS 623110), with total
revenues of $27.5 million or less in any
1 year. (For details, see the Small
Business Administration’s website at
https://www.sba.gov/category/
navigation-structure/contracting/
contracting-officials/eligibility-sizestandards). In addition, approximately
20 percent of SNFs classified as small
entities are non-profit organizations.
Finally, individuals and states are not
included in the definition of a small
entity.
This proposed rule sets forth updates
of the SNF PPS rates contained in the
SNF PPS final rule for FY 2019 (83 FR
39162). Based on the above, we estimate
that the aggregate impact for FY 2020
will be an increase of $887 million in
payments to SNFs, resulting from the
SNF market basket update to the
payment rates. While it is projected in
Table 18 that most providers would
experience a net increase in payments,
we note that some individual providers
within the same region or group may
experience different impacts on
payments than others due to the
distributional impact of the FY 2020
wage indexes, PDPM transition and the
degree of Medicare utilization.
Guidance issued by the Department of
Health and Human Services on the
proper assessment of the impact on
small entities in rulemakings, utilizes a
cost or revenue impact of 3 to 5 percent
as a significance threshold under the
RFA. In their March 2019 Report to
Congress (available at https://
medpac.gov/docs/default-source/
reports/mar19_medpac_ch8_sec.pdf),
MedPAC states that Medicare covers
approximately 11 percent of total
patient days in freestanding facilities
and 19 percent of facility revenue
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(March 2019 MedPAC Report to
Congress, 197). As a result, for most
facilities, when all payers are included
in the revenue stream, the overall
impact on total revenues should be
substantially less than those impacts
presented in Table 18. As indicated in
Table 18, the effect on facilities is
projected to be an aggregate positive
impact of 2.5 percent for FY 2020. As
the overall impact on the industry as a
whole, and thus on small entities
specifically, is less than the 3 to 5
percent threshold discussed previously,
the Secretary has determined that this
proposed rule will not have a significant
impact on a substantial number of small
entities for FY 2020.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 603 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
an MSA and has fewer than 100 beds.
This proposed rule will affect small
rural hospitals that (1) furnish SNF
services under a swing-bed agreement or
(2) have a hospital-based SNF. We
anticipate that the impact on small rural
hospitals will be a positive impact.
Moreover, as noted in previous SNF PPS
final rules (most recently, the one for FY
2019 (83 FR 39288)), the category of
small rural hospitals is included within
the analysis of the impact of this
proposed rule on small entities in
general. As indicated in Table 18, the
effect on facilities for FY 2020 is
projected to be an aggregate positive
impact of 2.5 percent. As the overall
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impact on the industry as a whole is less
than the 3 to 5 percent threshold
discussed above, the Secretary has
determined that this final rule will not
have a significant impact on a
substantial number of small rural
hospitals for FY 2020.
C. Unfunded Mandates Reform Act
Analysis
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2019, that threshold is approximately
$154 million. This proposed rule will
impose no mandates on state, local, or
tribal governments or on the private
sector.
D. Federalism Analysis
Executive Order 13132 establishes
certain requirements that an agency
must meet when it issues a proposed
rule (and subsequent final rule) that
imposes substantial direct requirement
costs on state and local governments,
preempts state law, or otherwise has
federalism implications. This proposed
rule would have no substantial direct
effect on state and local governments,
preempt state law, or otherwise have
federalism implications.
E. Reducing Regulation and Controlling
Regulatory Costs
Executive Order 13771 (January 30,
2017) requires that the costs associated
with significant new regulations ‘‘to the
extent permitted by law, be offset by the
elimination of existing costs associated
with at least two prior regulations.’’
This proposed rule is not subject to the
requirements of E.O. 13771 because it is
expected to result in no more than de
minimis costs.
khammond on DSKBBV9HB2PROD with PROPOSALS3
F. Congressional Review Act
This proposed regulation is subject to
the Congressional Review Act
provisions of the Small Business
Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.) and has been
transmitted to the Congress and the
Comptroller General for review.
G. Regulatory Review Costs
If regulations impose administrative
costs on private entities, such as the
time needed to read and interpret this
proposed rule, we should estimate the
cost associated with regulatory review.
Due to the uncertainty involved with
accurately quantifying the number of
entities that will review the rule, we
assume that the total number of unique
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commenters on last year’s proposed rule
will be the number of reviewers of this
year’s proposed rule. We acknowledge
that this assumption may understate or
overstate the costs of reviewing this
rule. It is possible that not all
commenters reviewed last year’s rule in
detail, and it is also possible that some
reviewers chose not to comment on the
proposed rule. For these reasons, we
thought that the number of past
commenters 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 will review the proposed
rule.
We also recognize that different types
of entities are in many cases affected by
mutually exclusive sections of this
proposed rule, and therefore, for the
purposes of our estimate we assume that
each reviewer reads approximately 50
percent of the rule. We seek comments
on this assumption.
Using the wage information from the
BLS for medical and health service
managers (Code 11–9111), we estimate
that the cost of reviewing this rule is
$107.38 per hour, including overhead
and fringe benefits https://www.bls.gov/
oes/current/oes_nat.htm. Assuming an
average reading speed, we estimate that
it would take approximately 4 hours for
the staff to review half of the proposed
rule. For each SNF that reviews the rule,
the estimated cost is $429.52 (4 hours ×
$107.38). Therefore, we estimate that
the total cost of reviewing this
regulation is $124,561 ($429.52 × 290
reviewers).
In accordance with the provisions of
Executive Order 12866, this proposed
rule was reviewed by the Office of
Management and Budget.
List of Subjects
42 CFR Part 409
Health facilities, Medicare.
42 CFR Part 413
Diseases, Health facilities, Medicare,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR chapter IV as set forth below:
PART 409—HOSPITAL INSURANCE
BENEFITS
1. The authority citation for part 409
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
§ 409.30
[Amended]
2. Section 409.30 is amended in the
introductory text by removing the
■
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Frm 00071
Fmt 4701
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17689
phrase ‘‘the 5-day assessment’’ and
adding in its place the phrase ‘‘the
initial patient assessment’’.
PART 413—PRINCIPLES OF
REASONABLE COST
REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE
SERVICES; PROSPECTIVELY
DETERMINED PAYMENT RATES FOR
SKILLED NURSING FACILITIES;
PAYMENT FOR ACUTE KIDNEY
INJURY DIALYSIS
3. The authority citation for part 413
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395d(d),
1395f(b), 1395g, 1395l(a), (i), and (n),
1395x(v), 1395hh, 1395rr, 1395tt, and
1395ww; and sec. 124 of Public Law 106–
113, 113 Stat. 1501A–332; sec. 3201 of Public
Law 112–96, 126 Stat. 156; sec. 632 of Public
Law 112–240, 126 Stat. 2354; sec. 217 of
Public Law 113–93, 129 Stat. 1040; and sec.
204 of Public Law 113–295, 128 Stat. 4010;
and sec. 808 of Public Law 114–27, 129 Stat.
362.
4. Section 413.343 is amended by
revising paragraph (b) to read as follows:
■
§ 413.343
Resident assessment data.
*
*
*
*
*
(b) Assessment schedule. In
accordance with the methodology
described in § 413.337(c) related to the
adjustment of the Federal rates for casemix, SNFs must submit assessments
according to an assessment schedule.
This schedule must include
performance of an initial patient
assessment no later than the 8th day of
posthospital SNF care and such other
interim payment assessments as the
SNF determines are necessary to
account for changes in patient care
needs.
*
*
*
*
*
■ 5. Section 413.360 is amended by
revising paragraphs (a) and (d)(1) and
(4) to read as follows:
§ 413.360 Requirements under the Skilled
Nursing Facility (SNF) Quality Reporting
Program (QRP).
(a) Participation start date. Beginning
with the FY 2018 program year, a SNF
must begin reporting data in accordance
with paragraph (b) of this section no
later than the first day of the calendar
quarter subsequent to 30 days after the
date on its CMS Certification Number
(CCN) notification letter, which
designates the SNF as operating in the
CMS designated data submission
system. For purposes of this section, a
program year is the fiscal year in which
the market basket percentage described
in § 413.337(d) is reduced by two
percentage points if the SNF does not
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report data in accordance with
paragraph (b) of this section.
*
*
*
*
*
(d) * * *
(1) SNFs that do not meet the
requirements in paragraph (b) of this
section for a program year will receive
a notification of non-compliance sent
through at least one of the following
methods: The CMS designated data
submission system, the United States
Postal Service, or via an email from the
Medicare Administrative Contractor
(MAC). A SNF may request
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reconsideration no later than 30
calendar days after the date identified
on the letter of non-compliance.
*
*
*
*
*
(4) CMS will notify SNFs, in writing,
of its final decision regarding any
reconsideration request through at least
one of the following methods: CMS
designated data submission system, the
United States Postal Service, or via
email from the CMS Medicare
Administrative Contractor (MAC).
*
*
*
*
*
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Frm 00072
Fmt 4701
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Dated: March 26, 2019.
Seema Verma
Administrator, Centers for Medicare &
Medicaid Services.
Dated: April 2, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2019–08108 Filed 4–19–19; 4:15 p.m.]
BILLING CODE 4120–01–P
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]]>Agencies
[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Proposed Rules]
[Pages 17620-17690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08108]
[[Page 17619]]
Vol. 84
Thursday,
No. 80
April 25, 2019
Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 409 and 413
Medicare Program; Prospective Payment System and Consolidated Billing
for Skilled Nursing Facilities; Updates to the Quality Reporting
Program and Value-Based Purchasing Program for Federal Fiscal Year
2020; Proposed Rule
Federal Register / Vol. 84 , No. 80 / Thursday, April 25, 2019 /
Proposed Rules
[[Page 17620]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409 and 413
[CMS-1718-P]
RIN 0938-AT75
Medicare Program; Prospective Payment System and Consolidated
Billing for Skilled Nursing Facilities; Updates to the Quality
Reporting Program and Value-Based Purchasing Program for Federal Fiscal
Year 2020
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would update the payment rates used under
the prospective payment system (PPS) for skilled nursing facilities
(SNFs) for fiscal year (FY) 2020. We also propose minor revisions to
the regulation text to reflect the revised assessment schedule under
Patient Driven Payment Model (PDPM). Additionally, we propose to revise
the definition of group therapy under the SNF PPS, and to implement a
subregulatory process for updating the code lists (International
Classification of Diseases, Tenth Version (ICD-10) codes) used under
PDPM. We are also soliciting comments on stakeholder concerns regarding
the appropriateness of the wage index used to adjust SNF payments. In
addition, the proposed rule includes proposals for the SNF Quality
Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP)
Program that will affect Medicare payment to SNFs.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on June 18, 2019.
ADDRESSES: In commenting, please refer to file code CMS-1718-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to https://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-1718-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1718-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Penny Gershman, (410) 786-6643, for
information related to SNF PPS clinical issues.
Anthony Hodge, (410) 786-6645, for information related to payment
for SNF-level swing-bed services.
John Kane, (410) 786-0557, for information related to the
development of the payment rates and case-mix indexes, and general
information.
Kia Sidbury, (410) 786-7816, for information related to the wage
index.
Bill Ullman, (410) 786-5667, for information related to level of
care determinations and consolidated billing.
Casey Freeman, (410) 786-4354, for information related to skilled
nursing facility quality reporting program.
James Poyer, (410) 786-2261, for information related to the skilled
nursing facility value-based purchasing program.
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: https://www.regulations.gov. Follow the search instructions on that website to
view public comments.
Availability of Certain Tables Exclusively Through the Internet on the
CMS Website
As discussed in the FY 2014 SNF PPS final rule (78 FR 47936),
tables setting forth the Wage Index for Urban Areas Based on CBSA Labor
Market Areas and the Wage Index Based on CBSA Labor Market Areas for
Rural Areas are no longer published in the Federal Register. Instead,
these tables are available exclusively through the internet on the CMS
website. The wage index tables for this proposed rule can be accessed
on the SNF PPS Wage Index home page, at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
Readers who experience any problems accessing any of these online
SNF PPS wage index tables should contact Kia Sidbury at (410) 786-7816.
To assist readers in referencing sections contained in this
document, we are providing the following Table of Contents.
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of Major Provisions
C. Summary of Cost and Benefits
D. Advancing Health Information Exchange
II. Background on SNF PPS
A. Statutory Basis and Scope
B. Initial Transition for the SNF PPS
C. Required Annual Rate Updates
III. Proposed SNF PPS Rate Setting Methodology and FY 2020 Update
A. Federal Base Rates
B. SNF Market Basket Update
C. Case-Mix Adjustment
D. Wage Index Adjustment
E. Wage Index Comment Solicitation
F. SNF Value-Based Purchasing Program
G. Adjusted Rate Computation Example
IV. Additional Aspects of the SNF PPS
A. SNF Level of Care--Administrative Presumption
B. Consolidated Billing
C. Payment for SNF-Level Swing-Bed Services
V. Issues Relating to PDPM Implementation
A. Revised Group Therapy Definition
B. Updating ICD-10 Code Mappings
C. Revisions to the Regulation Text
VI. Other Issues
A. Skilled Nursing Facility (SNF) Quality Reporting Program
(QRP)
B. Skilled Nursing Facility Value-Based Purchasing Program (SNF
VBP)
VII. Collection of Information Requirements
VIII. Response to Comments
IX. Economic Analyses
Regulations Text
I. Executive Summary
A. Purpose
This proposed rule would update the SNF prospective payment rates
for fiscal year (FY) 2020 as required under section 1888(e)(4)(E) of
the Social Security Act (the Act). It would also respond to section
1888(e)(4)(H) of the Act, which requires the Secretary to provide for
publication in the Federal Register, before the August 1 that precedes
the start of each FY, certain specified information relating to the
payment update (see section II.C. of this proposed rule). This proposed
rule also proposes to revise the definition of group therapy under the
SNF PPS and to implement a subregulatory process for updating ICD-10
code lists used under the PDPM.
[[Page 17621]]
Finally, this proposed rule would also update the Skilled Nursing
Facility Quality Reporting Program (SNF QRP) and Skilled Nursing
Facility Value-Based Purchasing Program (SNF VBP).
B. Summary of Major Provisions
In accordance with sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5) of
the Act, the federal rates in this proposed rule would reflect an
update to the rates that we published in the SNF PPS final rule for FY
2019 (83 FR 39162), as corrected in the FY 2019 SNF PPS correction
notice (83 FR 49832), which reflects the SNF market basket update, as
adjusted by the multifactor productivity (MFP) adjustment, for FY 2020.
In addition, we are proposing to revise the definition of group therapy
under the SNF PPS and to implement a subregulatory process for updating
ICD-10 code lists used under the PDPM.
This proposed rule proposes to update requirements for the SNF QRP,
including the proposal of two Transfer of Health Information quality
measures as well as standardized patient assessment data elements to
begin collection on October 1, 2020 in satisfaction of the Improving
Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub.
L. 113-185, enacted October 6, 2014). We are also proposing to exclude
baseline nursing home residents from the Discharge to Community
Measure. In addition, we are proposing to expand data collection for
SNF QRP quality measures to all skilled nursing facility residents,
regardless of their payer. Further, we are also proposing the public
display of the quality measure, Drug Regimen Review Conducted With
Follow-Up for Identified Issues- Post Acute Care (PAC) Skilled Nursing
Facility (SNF) Quality Reporting Program (QRP). We are also proposing
to revise references in regulation text to reflect enhancements to the
system used for the submission of data. Finally, we are requesting
information on quality measures and standardized resident assessment
data elements under consideration for future years.
In accordance with section 1888(h) of the Act, this proposed rule
would update certain policies for the SNF VBP.
C. Summary of Cost and Benefits
Table 1--Cost and Benefits
------------------------------------------------------------------------
Provision description Total transfers
------------------------------------------------------------------------
FY 2020 SNF PPS payment rate update.... The overall economic impact of
this proposed rule is an
estimated increase of $887
million in aggregate payments
to SNFs during FY 2020.
FY 2020 SNF VBP changes................ The overall economic impact of
the SNF VBP Program is an
estimated reduction of $213.6
million in aggregate payments
to SNFs during FY 2020.
------------------------------------------------------------------------
D. Advancing Health Information Exchange
The Department of Health and Human Services (HHS) has a number of
initiatives designed to encourage and support the adoption of
interoperable health information technology and to promote nationwide
health information exchange to improve health care. The Office of the
National Coordinator for Health Information Technology (ONC) and CMS
work collaboratively to advance interoperability across settings of
care, including post-acute care.
To further interoperability in post-acute care, we developed a Data
Element Library (DEL) to serve as a publicly available centralized,
authoritative resource for standardized data elements and their
associated mappings to health IT standards. The DEL furthers CMS' goal
of data standardization and interoperability, which is also a goal of
the Improving Medicare Post-Acute Care Transformation Act of 2014
(IMPACT Act). These interoperable data elements can reduce provider
burden by allowing the use and exchange of healthcare data, support
provider exchange of electronic health information for care
coordination, person-centered care, and support real-time, data driven,
clinical decision making. Standards in the Data Element Library
(https://del.cms.gov/) can be referenced on the CMS website and in the
ONC Interoperability Standards Advisory (ISA). The 2019 ISA is
available at https://www.healthit.gov/isa.
The 21st Century Cures Act (the Cures Act) (Pub. L. 114-255,
enacted December 13, 2016) requires HHS to take new steps to enable the
electronic sharing of health information ensuring interoperability for
providers and settings across the care continuum. In another important
provision, Congress defined ``information blocking'' as practices
likely to interfere with, prevent, or materially discourage access,
exchange, or use of electronic health information, and established new
authority for HHS to discourage these practices. In March 2019, ONC and
CMS published the proposed rules, ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program,'' (84 FR 7424) and ``Interoperability and
Patient Access'' (84 FR 7610) to promote secure and more immediate
access to health information for patients and healthcare providers
through the implementation of information blocking provisions of the
Cures Act and the use of standardized application programming
interfaces (APIs) that enable easier access to electronic health
information. These two proposed rules are open for public comment at
www.regulations.gov. We invite providers to learn more about these
important developments and how they are likely to affect SNFs.
II. Background on SNF PPS
A. Statutory Basis and Scope
As amended by section 4432 of the Balanced Budget Act of 1997 (BBA
1997) (Pub. L. 105-33, enacted on August 5, 1997), section 1888(e) of
the Act provides for the implementation of a PPS for SNFs. This
methodology uses prospective, case-mix adjusted per diem payment rates
applicable to all covered SNF services defined in section 1888(e)(2)(A)
of the Act. The SNF PPS is effective for cost reporting periods
beginning on or after July 1, 1998, and covers all costs of furnishing
covered SNF services (routine, ancillary, and capital-related costs)
other than costs associated with approved educational activities and
bad debts. Under section 1888(e)(2)(A)(i) of the Act, covered SNF
services include post-hospital extended care services for which
benefits are provided under Part A, as well as those items and services
(other than a small number of excluded services, such as physicians'
services) for which payment may otherwise be made under Part B and
which are furnished to Medicare beneficiaries who are residents in a
SNF during a covered Part A stay. A comprehensive discussion of these
provisions appears in the May 12, 1998
[[Page 17622]]
interim final rule (63 FR 26252). In addition, a detailed discussion of
the legislative history of the SNF PPS is available online at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Legislative_History_2018-10-01.pdf.
Section 215(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added section 1888(g)
to the Act requiring the Secretary to specify an all-cause all-
condition hospital readmission measure and an all-condition risk-
adjusted potentially preventable hospital readmission measure for the
SNF setting. Additionally, section 215(b) of PAMA added section 1888(h)
to the Act requiring the Secretary to implement a VBP program for SNFs.
Finally, section 2(c)(4) of the IMPACT Act amended section 1888(e)(6)
to the Act, which requires the Secretary to implement a quality
reporting program for SNFs under which SNFs report data on measures and
resident assessment data.
B. Initial Transition for the SNF PPS
Under sections 1888(e)(1)(A) and 1888(e)(11) of the Act, the SNF
PPS included an initial, three-phase transition that blended a
facility-specific rate (reflecting the individual facility's historical
cost experience) with the federal case-mix adjusted rate. The
transition extended through the facility's first 3 cost reporting
periods under the PPS, up to and including the one that began in FY
2001. Thus, the SNF PPS is no longer operating under the transition, as
all facilities have been paid at the full federal rate effective with
cost reporting periods beginning in FY 2002. As we now base payments
for SNFs entirely on the adjusted federal per diem rates, we no longer
include adjustment factors under the transition related to facility-
specific rates for the upcoming FY.
C. Required Annual Rate Updates
Section 1888(e)(4)(E) of the Act requires the SNF PPS payment rates
to be updated annually. The most recent annual update occurred in a
final rule that set forth updates to the SNF PPS payment rates for FY
2019 (83 FR 39162), as corrected in the FY 2019 SNF PPS correction
notice (83 FR 49832).
Section 1888(e)(4)(H) of the Act specifies that we provide for
publication annually in the Federal Register of the following:
The unadjusted federal per diem rates to be applied to
days of covered SNF services furnished during the upcoming FY.
The case-mix classification system to be applied for these
services during the upcoming FY.
The factors to be applied in making the area wage
adjustment for these services.
Along with other revisions discussed later in this preamble, this
proposed rule will provide the required annual updates to the per diem
payment rates for SNFs for FY 2020.
III. Proposed SNF PPS Rate Setting Methodology and FY 2020 Update
A. Federal Base Rates
Under section 1888(e)(4) of the Act, the SNF PPS uses per diem
federal payment rates based on mean SNF costs in a base year (FY 1995)
updated for inflation to the first effective period of the PPS. We
developed the federal payment rates using allowable costs from
hospital-based and freestanding SNF cost reports for reporting periods
beginning in FY 1995. The data used in developing the federal rates
also incorporated a Part B add-on, which is an estimate of the amounts
that, prior to the SNF PPS, would be payable under Part B for covered
SNF services furnished to individuals during the course of a covered
Part A stay in a SNF.
In developing the rates for the initial period, we updated costs to
the first effective year of the PPS (the 15-month period beginning July
1, 1998) using a SNF market basket index, and then standardized for
geographic variations in wages and for the costs of facility
differences in case mix. In compiling the database used to compute the
federal payment rates, we excluded those providers that received new
provider exemptions from the routine cost limits, as well as costs
related to payments for exceptions to the routine cost limits. Using
the formula that the BBA 1997 prescribed, we set the federal rates at a
level equal to the weighted mean of freestanding costs plus 50 percent
of the difference between the freestanding mean and weighted mean of
all SNF costs (hospital-based and freestanding) combined. We computed
and applied separately the payment rates for facilities located in
urban and rural areas, and adjusted the portion of the federal rate
attributable to wage-related costs by a wage index to reflect
geographic variations in wages.
B. SNF Market Basket Update
1. SNF Market Basket Index
Section 1888(e)(5)(A) of the Act requires us to establish a SNF
market basket index that reflects changes over time in the prices of an
appropriate mix of goods and services included in covered SNF services.
Accordingly, we have developed a SNF market basket index that
encompasses the most commonly used cost categories for SNF routine
services, ancillary services, and capital-related expenses. In the SNF
PPS final rule for FY 2018 (82 FR 36548 through 36566), we revised and
rebased the market basket index, which included updating the base year
from FY 2010 to 2014.
The SNF market basket index is used to compute the market basket
percentage change that is used to update the SNF federal rates on an
annual basis, as required by section 1888(e)(4)(E)(ii)(IV) of the Act.
This market basket percentage update is adjusted by a forecast error
correction, if applicable, and then further adjusted by the application
of a productivity adjustment as required by section 1888(e)(5)(B)(ii)
of the Act and described in section III.B.4. of this proposed rule. For
FY 2020, the growth rate of the 2014-based SNF market basket is
estimated to be 3.0 percent, based on the IHS Global Insight, Inc.
(IGI) first quarter 2019 forecast with historical data through fourth
quarter 2018, before the multifactor productivity adjustment is
applied.
In section III.B.5. of this proposed rule, we discuss the 2 percent
reduction applied to the market basket update for those SNFs that fail
to submit measures data as required by section 1888(e)(6)(A) of the
Act.
2. Use of the SNF Market Basket Percentage
Section 1888(e)(5)(B) of the Act defines the SNF market basket
percentage as the percentage change in the SNF market basket index from
the midpoint of the previous FY to the midpoint of the current FY. For
the federal rates set forth in this proposed rule, we use the
percentage change in the SNF market basket index to compute the update
factor for FY 2020. This factor is based on the FY 2020 percentage
increase in the 2014-based SNF market basket index reflecting routine,
ancillary, and capital-related expenses. In this proposed rule, the SNF
market basket percentage is estimated to be 3.0 percent for FY 2020
based on IGI's first quarter 2019 forecast (with historical data
through fourth quarter 2018). Finally, as discussed in section II.B. of
this proposed rule, we no longer compute update factors to adjust a
facility-specific portion of the SNF PPS rates, because the initial
three-phase transition period from facility-specific to full federal
rates that started with cost reporting periods beginning in July 1998
has expired.
[[Page 17623]]
3. Forecast Error Adjustment
As discussed in the June 10, 2003 supplemental proposed rule (68 FR
34768) and finalized in the August 4, 2003 final rule (68 FR 46057
through 46059), Sec. 413.337(d)(2) provides for an adjustment to
account for market basket forecast error. The initial adjustment for
market basket forecast error applied to the update of the FY 2003 rate
for FY 2004, and took into account the cumulative forecast error for
the period from FY 2000 through FY 2002, resulting in an increase of
3.26 percent to the FY 2004 update. Subsequent adjustments in
succeeding FYs take into account the forecast error from the most
recently available FY for which there is final data, and apply the
difference between the forecasted and actual change in the market
basket when the difference exceeds a specified threshold. We originally
used a 0.25 percentage point threshold for this purpose; however, for
the reasons specified in the FY 2008 SNF PPS final rule (72 FR 43425,
August 3, 2007), we adopted a 0.5 percentage point threshold effective
for FY 2008 and subsequent FYs. As we stated in the final rule for FY
2004 that first issued the market basket forecast error adjustment (68
FR 46058, August 4, 2003), the adjustment will reflect both upward and
downward adjustments, as appropriate.
For FY 2018 (the most recently available FY for which there is
final data), the estimated increase in the market basket index was 2.6
percentage points, and the actual increase for FY 2018 is 2.6
percentage points, resulting in the actual increase being the same as
the estimated increase. Accordingly, as the difference between the
estimated and actual amount of change in the market basket index does
not exceed the 0.5 percentage point threshold, the FY 2020 market
basket percentage change of 3.0 percent would not be adjusted to
account for the forecast error correction. Table 2 shows the forecasted
and actual market basket amounts for FY 2018.
Table 2--Difference Between the Forecasted and Actual Market Basket Increases for FY 2018
----------------------------------------------------------------------------------------------------------------
Forecasted FY Actual FY 2018 FY 2018
Index 2018 increase * increase ** difference
----------------------------------------------------------------------------------------------------------------
SNF.......................................................... 2.6 2.6 0.0
----------------------------------------------------------------------------------------------------------------
* Published in Federal Register; based on second quarter 2017 IGI forecast (2010-based index).
** Based on the first quarter 2019 IGI forecast, with historical data through the fourth quarter 2018 (2010-
based index).
4. Multifactor Productivity Adjustment
Section 1888(e)(5)(B)(ii) of the Act, as added by section 3401(b)
of the Patient Protection and Affordable Care Act (Affordable Care Act)
(Pub. L. 111-148, enacted on March 23, 2010) requires that, in FY 2012
and in subsequent FYs, the market basket percentage under the SNF
payment system (as described in section 1888(e)(5)(B)(i) of the Act) is
to be reduced annually by the multifactor productivity (MFP) adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act. Section
1886(b)(3)(B)(xi)(II) of the Act, in turn, defines the MFP adjustment
to be equal to the 10-year moving average of changes in annual economy-
wide private nonfarm business multi-factor productivity (as projected
by the Secretary for the 10-year period ending with the applicable FY,
year, cost-reporting period, or other annual period). The Bureau of
Labor Statistics (BLS) is the agency that publishes the official
measure of private nonfarm business MFP. We refer readers to the BLS
website at https://www.bls.gov/mfp for the BLS historical published MFP
data.
MFP is derived by subtracting the contribution of labor and capital
inputs growth from output growth. The projections of the components of
MFP are currently produced by IGI, a nationally recognized economic
forecasting firm with which CMS contracts to forecast the components of
the market baskets and MFP. To generate a forecast of MFP, IGI
replicates the MFP measure calculated by the BLS, using a series of
proxy variables derived from IGI's U.S. macroeconomic models. For a
discussion of the MFP projection methodology, we refer readers to the
FY 2012 SNF PPS final rule (76 FR 48527 through 48529) and the FY 2016
SNF PPS final rule (80 FR 46395). A complete description of the MFP
projection methodology is available on our website at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html.
a. Incorporating the MFP Adjustment Into the Market Basket Update
Per section 1888(e)(5)(A) of the Act, the Secretary shall establish
a SNF market basket index that reflects changes over time in the prices
of an appropriate mix of goods and services included in covered SNF
services. Section 1888(e)(5)(B)(ii) of the Act, added by section
3401(b) of the Affordable Care Act, requires that for FY 2012 and each
subsequent FY, after determining the market basket percentage described
in section 1888(e)(5)(B)(i) of the Act, the Secretary shall reduce such
percentage by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act (which we refer to as the MFP
adjustment). Section 1888(e)(5)(B)(ii) of the Act further states that
the reduction of the market basket percentage by the MFP adjustment may
result in the market basket percentage being less than zero for a FY,
and may result in payment rates under section 1888(e) of the Act being
less than such payment rates for the preceding fiscal year. Thus, if
the application of the MFP adjustment to the market basket percentage
calculated under section 1888(e)(5)(B)(i) of the Act results in an MFP-
adjusted market basket percentage that is less than zero, then the
annual update to the unadjusted federal per diem rates under section
1888(e)(4)(E)(ii) of the Act would be negative, and such rates would
decrease relative to the prior FY.
The MFP adjustment, calculated as the 10-year moving average of
changes in MFP for the period ending September 30, 2020, is estimated
to be 0.5 percent based on IGI's first quarter 2019 forecast. Also,
consistent with section 1888(e)(5)(B)(i) of the Act and Sec.
413.337(d)(2), the market basket percentage for FY 2020 for the SNF PPS
is based on IGI's first quarter 2019 forecast of the SNF market basket
percentage, which is estimated to be 3.0 percent. In accordance with
section 1888(e)(5)(B)(ii) of the Act and Sec. 413.337(d)(3), this
market basket percentage is then reduced by the MFP adjustment of 0.5
percent. The resulting MFP-adjusted SNF market basket update would be
equal to 2.5 percent, or 3.0 percent less 0.5 percentage point.
[[Page 17624]]
5. Market Basket Update Factor for FY 2020
Sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5)(i) of the Act require
that the update factor used to establish the FY 2020 unadjusted federal
rates be at a level equal to the market basket index percentage change.
Accordingly, we determined the total growth from the average market
basket level for the period of October 1, 2018, through September 30,
2019 to the average market basket level for the period of October 1,
2019, through September 30, 2020. This process yields a percentage
change in the 2014-based SNF market basket of 3.0 percent. As further
explained in section III.B.3. of this proposed rule, as applicable, we
adjust the market basket percentage change by the forecast error from
the most recently available FY for which there is final data and apply
this adjustment whenever the difference between the forecasted and
actual percentage change in the market basket exceeds a 0.5 percentage
point threshold. Since the difference between the forecasted FY 2018
SNF market basket percentage change and the actual FY 2018 SNF market
basket percentage change (FY 2018 is the most recently available FY for
which there is historical data) did not exceed the 0.5 percentage point
threshold, the FY 2020 market basket percentage change of 3.0 percent
would not be adjusted by the forecast error correction.
Section 1888(e)(5)(B)(ii) of the Act requires us to reduce the
market basket percentage change by the MFP adjustment (10-year moving
average of changes in MFP for the period ending September 30, 2020) of
0.5 percent, as described in section III.B.4 of this proposed rule. The
resulting net SNF market basket update would equal 2.5 percent, or 3.0
percent less the 0.5 percentage point MFP adjustment. We note that our
policy has been that, if more recent data become available (for
example, a more recent estimate of the SNF market basket and/or MFP
adjustment), we would use such data, if appropriate, to determine the
SNF market basket percentage change, labor-related share relative
importance, forecast error adjustment, and MFP adjustment in the SNF
PPS final rule.
We also note that section 1888(e)(6)(A)(i) of the Act provides
that, beginning with FY 2018, SNFs that fail to submit data, as
applicable, in accordance with sections 1888(e)(6)(B)(i)(II) and (III)
of the Act for a fiscal year will receive a 2.0 percentage point
reduction to their market basket update for the fiscal year involved,
after application of section 1888(e)(5)(B)(ii) of the Act (the MFP
adjustment) and section 1888(e)(5)(B)(iii) of the Act (the 1 percent
market basket increase for FY 2018). In addition, section
1888(e)(6)(A)(ii) of the Act states that application of the 2.0
percentage point reduction (after application of section
1888(e)(5)(B)(ii) and (iii) of the Act) may result in the market basket
index percentage change being less than 0.0 for a fiscal year, and may
result in payment rates for a fiscal year being less than such payment
rates for the preceding fiscal year. Section 1888(e)(6)(A)(iii) of the
Act further specifies that the 2.0 percentage point reduction is
applied in a noncumulative manner, so that any reduction made under
section 1888(e)(6)(A)(i) of the Act applies only with respect to the
fiscal year involved, and that the reduction cannot be taken into
account in computing the payment amount for a subsequent fiscal year.
Accordingly, for the reasons specified in this proposed rule, we
are proposing to apply the FY 2020 SNF market basket increase factor of
2.5 percent in our determination of the FY 2020 SNF PPS unadjusted
federal per diem rates, which reflects a market basket increase factor
of 3.0 percent, less the 0.5 percentage point MFP-adjustment.
6. Unadjusted Federal per Diem Rates for FY 2020
As discussed in the FY 2019 SNF PPS final rule (83 FR 39162), we
are implementing a new case-mix classification system to classify SNF
patients under the SNF PPS, beginning in FY 2020, called the Patient
Driven Payment Model (PDPM). As discussed in section V.B of that final
rule, under PDPM, the unadjusted Federal per diem rates are divided
into six components, five of which are case-mix adjusted components
(Physical Therapy (PT), Occupational Therapy (OT), Speech-Language
Pathology (SLP), Nursing, and Non-Therapy Ancillaries (NTA)), and one
of which is a non-case-mix component, as exists under RUG-IV. In
calculating the FY 2020 unadjusted Federal per diem rates that would be
used under PDPM in FY 2020, we applied the FY 2020 MFP-adjusted market
basket increase factor to the unadjusted Federal per diem rates
provided in Tables 4 and 5 of the FY 2019 SNF PPS final rule (83 FR
39169) and then applied the methodology for separating the RUG-IV base
rates into the PDPM base rates, as discussed and finalized in section
V.B.3 of the FY 2019 SNF PPS final rule (83 FR 39191 through 39194).
Tables 3 and 4 reflect the proposed updated unadjusted federal
rates for FY 2020, prior to adjustment for case-mix.
Table 3--FY 2020 Unadjusted Federal Rate Per Diem--Urban
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rate component PT OT SLP Nursing NTA Non-case-mix
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per Diem Amount................................... $61.16 $56.93 $22.83 $106.64 $80.45 $95.48
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 17625]]
Table 4--FY 2020 Unadjusted Federal Rate Per Diem--Rural
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rate component PT OT SLP Nursing NTA Non-case-mix
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per Diem Amount................................... $69.72 $64.03 $28.76 $101.88 $76.86 $97.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
C. Case-Mix Adjustment
Under section 1888(e)(4)(G)(i) of the Act, the federal rate also
incorporates an adjustment to account for facility case-mix, using a
classification system that accounts for the relative resource
utilization of different patient types. The statute specifies that the
adjustment is to reflect both a resident classification system that the
Secretary establishes to account for the relative resource use of
different patient types, as well as resident assessment data and other
data that the Secretary considers appropriate. In the FY 2019 final
rule (83 FR 39162, August 8, 2018), we finalized a new case-mix
classification model, the PDPM, to take effect beginning October 1,
2019. The RUG-IV model classifies most patients into a therapy payment
group and primarily uses the volume of therapy services provided to the
patient as the basis for payment classification, thus inadvertently
creating an incentive for SNFs to furnish therapy regardless of the
individual patient's unique characteristics, goals, or needs. PDPM
eliminates this incentive and improves the overall accuracy and
appropriateness of SNF payments by classifying patients into payment
groups based on specific, data-driven patient characteristics, while
simultaneously reducing the administrative burden on SNFs.
The PDPM (like the RUG-IV) uses clinical data from the MDS to
assign case-mix classifiers to each patient that are then used to
calculate a per diem payment under the SNF PPS. As discussed in section
IV.A. of this proposed rule, the clinical orientation of the case-mix
classification system supports the SNF PPS's use of an administrative
presumption that considers a beneficiary's initial case-mix
classification to assist in making certain SNF level of care
determinations. Further, because the MDS is used as a basis for
payment, as well as a clinical assessment, we have provided extensive
training on proper coding and the timeframes for MDS completion in our
Resident Assessment Instrument (RAI) Manual. For an MDS to be
considered valid for use in determining payment, the MDS assessment
must be completed in compliance with the instructions in the RAI Manual
in effect at the time the assessment is completed. For payment and
quality monitoring purposes, the RAI Manual consists of both the Manual
instructions and the interpretive guidance and policy clarifications
posted on the appropriate MDS website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html.
Under section 1888(e)(4)(H), each update of the payment rates must
include the case-mix classification methodology applicable for the
upcoming FY. The FY 2020 payment rates set forth in this proposed rule
reflect the use of the PDPM case-mix classification system from October
1, 2019, through September 30, 2020. We list the proposed case-mix
adjusted PDPM payment rates for FY 2020, provided separately for urban
and rural SNFs, in Tables 6 and 7 with corresponding case-mix values.
As discussed in the FY 2019 SNF PPS final rule (83 FR 39255 through
39256), we finalized the implementation of PDPM in a budget neutral
manner. To accomplish this, as discussed in the FY 2019 SNF PPS final
rule (83 FR 39256), the unadjusted PDPM case mix indexes (CMIs) were
multiplied by 1.46 so that the total estimated payments under the PDPM
would be equal to the total actual payments under RUG-IV. Further,
section 3.11.2 of the PDPM technical report, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/PDPM_Technical_Report_508.pdf, provided additional detail on the
calculation of the PDPM CMIs in order to achieve budget neutrality. In
that section, it states that ``to align the distribution of resources
across components with the statutory base rates, Acumen set CMIs such
that the average product of the CMI and the variable per diem
adjustment factor for a day of care is the same (set to 1) for each of
the five case-mix-adjusted components in PDPM. To do this, Acumen first
calculated the product of the CMI and the adjustment factor for every
utilization day for each component. Then, we calculated the average of
this product for each component. Finally, Acumen calculated the ratio
of 1 divided by the average product for each component. This ratio is
the standardization multiplier, shown in Table 65 for each component.''
As discussed in section 3.11.2 of the PDPM Technical Report, the
standardization multiplier is used to align the distribution of
resources across components with the statutory base rates by setting
the CMIs such that the average product of the component CMI and the
variable per diem adjustment factor for that component for a day of
care is the same. Effectively, the standardization multiplier is used
to mitigate the effect of the variable per diem adjustment when
calculating budget neutrality. The CMIs were adjusted such that total
payments under PDPM, if it had been in effect in FY 2017, equal total
actual payments made under RUG-IV in FY 2017.
In this proposed rule, we propose to update the payment year used
as the basis for the calculation of the standardization multiplier and
budget neutrality multiplier, in order to best ensure that PDPM will be
implemented in a budget neutral manner, as finalized in the FY 2019 SNF
PPS final rule. The only difference in methodology between that used to
calculate these multipliers and CMIs in the FY 2019 SNF PPS final rule
and that used to calculate the multipliers and CMIs in this proposed
rule is that, in this proposed rule, we are updating the data used from
FY 2017 data to FY 2018 data. The impact of using the updated FY 2018
data and the proposed updated adjustment multipliers for
standardization and budget neutrality, is provided in Table 5. We would
note that while the multipliers discussed in the FY 2019 SNF PPS final
rule and in the PDPM Technical Report are given to the hundredths
place, in order to make clear the effect of this change in data, the
multipliers in Table 5 are shown to the thousandths place. The CMIs
provided in Tables 6 and 7 reflect the use of the proposed multipliers
in Table 5, based on the update to FY 2018 data.
[[Page 17626]]
Table 5--Proposed PDPM Standardization and Budget Neutrality Multipliers
----------------------------------------------------------------------------------------------------------------
FY 2017 data FY 2018 data
---------------------------------------------------------------------------
Component Standardization Budget neutrality Standardization Budget neutrality
multiplier multiplier multiplier multiplier
----------------------------------------------------------------------------------------------------------------
PT.................................. 1.031 1.458 1.028 1.463
OT.................................. 1.030 1.458 1.028 1.463
SLP................................. 0.995 1.458 0.996 1.463
Nursing............................. 0.995 1.458 0.996 1.463
NTA................................. 0.817 1.458 0.811 1.463
----------------------------------------------------------------------------------------------------------------
Given the differences between RUG-IV and PDPM in terms of patient
classification and billing, it is important that the format of Tables 6
and 7 reflect these differences. More specifically, under both RUG-IV
and PDPM, providers use a Health Insurance Prospective Payment System
(HIPPS) code on a claim in order to bill for covered SNF services.
Under RUG-IV, the HIPPS code includes the three character RUG-IV group
into which the patient classifies as well as a two character assessment
indicator code that represents the assessment used to generate this
code. Under PDPM, while providers would still use a HIPPS code, the
characters in that code represent different things. For example, the
first character represents the PT and OT group into which the patient
classifies. If the patient is classified into the PT and OT group
``TA'', then the first character in the patient's HIPPS code would be
an A. Similarly, if the patient is classified into the SLP group
``SB'', then the second character in the patient's HIPPS code would be
a B. The third character represents the Nursing group into which the
patient classifies. The fourth character represents the NTA group into
which the patient classifies. Finally, the fifth character represents
the assessment used to generate the HIPPS code.
Therefore, we have modified the format of Tables 6 and 7 from what
we have used for similar tables in prior SNF PPS rulemaking, such as
Tables 6 and 7 of the FY 2019 SNF PPS final rule (83 FR 39170 through
39172). Column 1 of Tables 6 and 7 represents the character in the
HIPPS code associated with a given PDPM component. Columns 2 and 3
provide the case-mix index and associated case-mix adjusted component
rate, respectively, for the relevant PT group. Columns 4 and 5 provide
the case-mix index and associated case-mix adjusted component rate,
respectively, for the relevant OT group. Columns 6 and 7 provide the
case-mix index and associated case-mix adjusted component rate,
respectively, for the relevant SLP group. Column 8 provides the nursing
case-mix group (CMG) that is connected with a given PDPM HIPPS
character. For example, if the patient qualified for the nursing group
CBC1, then the third character in the patient's HIPPS code would be a
``P.'' Columns 9 and 10 provide the case-mix index and associated case-
mix adjusted component rate, respectively, for the relevant nursing
group. Finally, columns 11 and 12 provide the case-mix index and
associated case-mix adjusted component rate, respectively, for the
relevant NTA group. Tables 6 and 7 do not reflect adjustments which may
be made to the SNF PPS rates as a result of either the SNF QRP,
discussed in section VI.B. of this proposed rule, or the SNF VBP
program, discussed in sections III.B.5. and VI.C. of this proposed
rule, or other adjustments, such as the variable per diem adjustment.
Further, we use the revised OMB delineations adopted in the FY 2015 SNF
PPS final rule (79 FR 45632, 45634), with updates as reflected in OMB
Bulletin Nos, 15-01 and 17-01, to identify a facility's urban or rural
status for the purpose of determining which set of rate tables would
apply to the facility.
BILLING CODE 4120-01-P
[[Page 17627]]
[GRAPHIC] [TIFF OMITTED] TP25AP19.004
[[Page 17628]]
[GRAPHIC] [TIFF OMITTED] TP25AP19.005
BILLING CODE 4120-01-C
D. Wage Index Adjustment
Section 1888(e)(4)(G)(ii) of the Act requires that we adjust the
federal rates to account for differences in area wage levels, using a
wage index that the Secretary determines appropriate. Since the
inception of the SNF PPS, we have used hospital inpatient wage data in
developing a wage index to be applied to SNFs. We propose to continue
this practice for FY 2020, as we continue to believe that in the
absence of SNF-specific wage data, using the hospital inpatient wage
index data is appropriate and reasonable for the SNF PPS. As explained
in the update notice for FY 2005 (69 FR 45786), the SNF PPS does not
use the hospital area wage index's occupational mix adjustment, as this
adjustment serves specifically to define the occupational categories
more clearly in a hospital setting; moreover, the collection of the
occupational wage data also excludes any wage data related to SNFs.
Therefore, we believe that using the updated wage data exclusive of the
occupational mix adjustment continues to be appropriate for SNF
payments. As in previous years, we would continue to use the pre-
reclassified IPPS hospital wage data, unadjusted for occupational mix
and the rural floor, as the basis for the SNF PPS wage index. For FY
2020, the updated wage data are for hospital cost reporting periods
beginning on or after October 1, 2015 and before October 1, 2016 (FY
2016 cost report data).
We note that section 315 of the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-
554, enacted on December 21, 2000) authorized us to establish a
geographic reclassification procedure that is specific to SNFs, but
only after collecting the data necessary to establish a SNF PPS wage
index that is based on wage data from nursing homes. However, to date,
this has proven to be unfeasible due to the volatility of existing SNF
wage data and the significant amount of resources that would be
required to improve the quality of that data. More specifically,
auditing all SNF cost reports, similar to the process used to audit
inpatient hospital cost reports for purposes of the Inpatient
Prospective Payment System (IPPS) wage index, would place a burden on
providers in terms of recordkeeping and completion of the cost report
worksheet. As discussed in greater detail later in this section,
adopting such an approach would require a significant commitment of
resources by CMS and the Medicare Administrative Contractors,
potentially far in excess of those required under the IPPS given that
there are nearly five times as many SNFs as there are inpatient
hospitals. Therefore, while we continue to believe that the development
of such an audit process could improve SNF cost reports in such a
manner as to permit us to establish a SNF-specific wage index, we do
not regard an undertaking of this magnitude as being feasible within
the current level of programmatic resources.
In addition, we propose to continue to use the same methodology
discussed in the SNF PPS final rule for FY 2008 (72 FR 43423) to
address those geographic areas in which there are no hospitals, and
thus, no hospital wage index data on which to base the calculation of
the
[[Page 17629]]
FY 2019 SNF PPS wage index. For rural geographic areas that do not have
hospitals, and therefore, lack hospital wage data on which to base an
area wage adjustment, we would use the average wage index from all
contiguous Core-Based Statistical Areas (CBSAs) as a reasonable proxy.
For FY 2020, there are no rural geographic areas that do not have
hospitals, and thus, this methodology would not be applied. For rural
Puerto Rico, we would not apply this methodology due to the distinct
economic circumstances that exist there (for example, due to the close
proximity to one another of almost all of Puerto Rico's various urban
and non-urban areas, this methodology would produce a wage index for
rural Puerto Rico that is higher than that in half of its urban areas);
instead, we would continue to use the most recent wage index previously
available for that area. For urban areas without specific hospital wage
index data, we would use the average wage indexes of all of the urban
areas within the state to serve as a reasonable proxy for the wage
index of that urban CBSA. For FY 2020, the only urban area without wage
index data available is CBSA 25980, Hinesville-Fort Stewart, GA. The
final wage index applicable to FY 2020 is set forth in Tables A and B
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
In the SNF PPS final rule for FY 2006 (70 FR 45026, August 4,
2005), we adopted the changes discussed in OMB Bulletin No. 03-04 (June
6, 2003), which announced revised definitions for MSAs and the creation
of micropolitan statistical areas and combined statistical areas. In
adopting the CBSA geographic designations, we provided for a 1-year
transition in FY 2006 with a blended wage index for all providers. For
FY 2006, the wage index for each provider consisted of a blend of 50
percent of the FY 2006 MSA-based wage index and 50 percent of the FY
2006 CBSA-based wage index (both using FY 2002 hospital data). We
referred to the blended wage index as the FY 2006 SNF PPS transition
wage index. As discussed in the SNF PPS final rule for FY 2006 (70 FR
45041), since the expiration of this 1-year transition on September 30,
2006, we have used the full CBSA-based wage index values.
In the FY 2015 SNF PPS final rule (79 FR 45644 through 45646), we
finalized changes to the SNF PPS wage index based on the newest OMB
delineations, as described in OMB Bulletin No. 13-01, beginning in FY
2015, including a 1-year transition with a blended wage index for FY
2015. OMB Bulletin No. 13-01 established revised delineations for
Metropolitan Statistical Areas, Micropolitan Statistical Areas, and
Combined Statistical Areas in the United States and Puerto Rico based
on the 2010 Census, and provided guidance on the use of the
delineations of these statistical areas using standards published on
June 28, 2010 in the Federal Register (75 FR 37246 through 37252).
Subsequently, on July 15, 2015, OMB issued OMB Bulletin No. 15-01,
which provides minor updates to and supersedes OMB Bulletin No. 13-01
that was issued on February 28, 2013. The attachment to OMB Bulletin
No. 15-01 provides detailed information on the update to statistical
areas since February 28, 2013. The updates provided in OMB Bulletin No.
15-01 are based on the application of the 2010 Standards for
Delineating Metropolitan and Micropolitan Statistical Areas to Census
Bureau population estimates for July 1, 2012 and July 1, 2013. In
addition, on August 15, 2017, OMB issued Bulletin No. 17-01 which
announced a new urban CBSA, Twin Falls, Idaho (CBSA 46300). As we
previously stated in the FY 2008 SNF PPS proposed and final rules (72
FR 25538 through 25539, and 72 FR 43423), we wish to note that this and
all subsequent SNF PPS rules and notices are considered to incorporate
any updates and revisions set forth in the most recent OMB bulletin
that applies to the hospital wage data used to determine the current
SNF PPS wage index.
Once calculated, we would apply the wage index adjustment to the
labor-related portion of the federal rate. Each year, we calculate a
revised labor-related share, based on the relative importance of labor-
related cost categories (that is, those cost categories that are labor-
intensive and vary with the local labor market) in the input price
index. In the SNF PPS final rule for FY 2018 (82 FR 36548 through
36566), we finalized a proposal to revise the labor-related share to
reflect the relative importance of the 2014-based SNF market basket
cost weights for the following cost categories: Wages and Salaries;
Employee Benefits; Professional Fees: Labor-Related; Administrative and
Facilities Support Services; Installation, Maintenance, and Repair
Services; All Other: Labor-Related Services; and a proportion of
Capital-Related expenses.
We calculate the labor-related relative importance from the SNF
market basket, and it approximates the labor-related portion of the
total costs after taking into account historical and projected price
changes between the base year and FY 2020. The price proxies that move
the different cost categories in the market basket do not necessarily
change at the same rate, and the relative importance captures these
changes. Accordingly, the relative importance figure more closely
reflects the cost share weights for FY 2020 than the base year weights
from the SNF market basket.
We calculate the labor-related relative importance for FY 2020 in
four steps. First, we compute the FY 2020 price index level for the
total market basket and each cost category of the market basket.
Second, we calculate a ratio for each cost category by dividing the FY
2020 price index level for that cost category by the total market
basket price index level. Third, we determine the FY 2020 relative
importance for each cost category by multiplying this ratio by the base
year (2014) weight. Finally, we add the FY 2020 relative importance for
each of the labor-related cost categories (Wages and Salaries, Employee
Benefits, Professional Fees: Labor-Related, Administrative and
Facilities Support Services, Installation, Maintenance, and Repair
Services, All Other: Labor-related services, and a portion of Capital-
Related expenses) to produce the FY 2020 labor-related relative
importance. Table 8 summarizes the proposed labor-related share for FY
2020, based on IGI's first quarter 2019 forecast with historical data
through fourth quarter 2018, compared to the labor-related share that
was used for the FY 2019 SNF PPS final rule.
[[Page 17630]]
Table 8--Labor-Related Relative Importance, FY 2019 and FY 2020
------------------------------------------------------------------------
Relative Relative
importance, labor- importance, labor-
related, FY 2019 related, FY 2020
18:2 forecast \1\ 19:1 forecast \2\
------------------------------------------------------------------------
Wages and salaries................ 50.2 50.6
Employee benefits................. 10.1 10.0
Professional Fees: Labor-Related.. 3.7 3.7
Administrative and facilities 0.5 0.5
support services.................
Installation, Maintenance and 0.6 0.6
Repair Services..................
All Other: Labor Related Services. 2.5 2.5
Capital-related (.391)............ 2.9 2.9
-------------------------------------
Total......................... 70.5 70.8
------------------------------------------------------------------------
\1\ Published in the Federal Register; based on second quarter 2018 IGI
forecast.
\2\ Based on first quarter 2019 IGI forecast, with historical data
through fourth quarter 2018.
In order to calculate the labor portion of the case-mix adjusted
per diem rate, one would multiply the total case-mix adjusted per diem
rate, which is the sum of all five case-mix adjusted components into
which a patient classifies, and the non-case-mix component rate, by the
FY 2020 labor-related share percentage provided in Table 8. The
remaining portion of the rate would be the non-labor portion. In prior
years, we have included tables which provide the case-mix adjusted RUG-
IV rates, by RUG-IV group, broken out by total rate, labor portion and
non-labor portion, such as Table 9 of the FY 2019 SNF PPS final rule
(83 FR 39175). However, under PDPM, as the total rate is calculated as
a combination of six different component rates, five of which are case-
mix adjusted, and given the sheer volume of possible combinations of
these five case-mix adjusted components, it is not feasible to provide
tables similar to those that have existed in prior rulemaking.
Therefore, to aid stakeholders in understanding the effect of the
wage index on the calculation of the SNF per diem rate, we have
included a revised hypothetical rate calculation in Table 9.
Section 1888(e)(4)(G)(ii) of the Act also requires that we apply
this wage index in a manner that does not result in aggregate payments
under the SNF PPS that are greater or less than would otherwise be made
if the wage adjustment had not been made. For FY 2020 (federal rates
effective October 1, 2019), we would apply an adjustment to fulfill the
budget neutrality requirement. We would meet this requirement by
multiplying each of the components of the unadjusted federal rates by a
budget neutrality factor equal to the ratio of the weighted average
wage adjustment factor for FY 2019 to the weighted average wage
adjustment factor for FY 2020. For this calculation, we would use the
same FY 2018 claims utilization data for both the numerator and
denominator of this ratio. We define the wage adjustment factor used in
this calculation as the labor share of the rate component multiplied by
the wage index plus the non-labor share of the rate component. The
proposed budget neutrality factor for FY 2020 would be 1.0060.
E. Wage Index Comment Solicitation
As discussed above, historically, we have calculated the SNF PPS
wage index values using unadjusted wage index values from another
provider setting. Stakeholders have frequently commented on certain
aspects of the SNF PPS wage index values and their impact on payments.
We are soliciting comments on concerns stakeholders may have regarding
the wage index used to adjust SNF PPS payments and suggestions for
possible updates and improvements to the geographic adjustment of SNF
PPS payments.
F. SNF Value-Based Purchasing Program
Beginning with payment for services furnished on October 1, 2018,
section 1888(h) of the Act requires the Secretary to reduce the
adjusted Federal per diem rate determined under section 1888(e)(4)(G)
of the Act otherwise applicable to a SNF for services furnished during
a fiscal year by 2 percent, and to adjust the resulting rate for a SNF
by the value-based incentive payment amount earned by the SNF based on
the SNF's performance score for that fiscal year under the SNF VBP
Program. To implement these requirements, we finalized in the FY 2019
SNF PPS final rule the addition of Sec. 413.337(f) to our regulations
(83 FR 39178).
Please see section VI.B. of this proposed rule for a discussion of
our proposals for the SNF VBP Program.
G. Adjusted Rate Computation Example
The following series of tables provides an example of how payment
would be calculated during FY 2020 under PDPM for a hypothetical 30 day
SNF stay, involving the hypothetical SNF XYZ, located in Frederick, MD
(Urban CBSA 43524), for a hypothetical patient who is classified into
such groups that the patient's HIPPS code is NHNC1. Table 9 shows the
adjustments made to the federal per diem rates (prior to application of
any adjustments under the SNF QRP and SNF VBP programs as discussed
above) to compute the provider's case-mix adjusted per diem rate for FY
2020, based on the patient's PDPM classification, as well as how the
VPD adjustment factor affects calculation of the per diem rate for a
given day of the stay. Table 10 shows the adjustments made to the case-
mix adjusted per diem rate from Table 9 to account for the provider's
wage index. The wage index used in this example is based on the FY 2020
SNF PPS wage index that appears in Table A available on the CMS website
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html. Finally, Table 11 provides the case-mix and wage index
adjusted per-diem rate for this patient for each day of the 30-day
stay, as well as the total payment for this stay. Table 11 also
includes the variable per diem (VPD) adjustment factors for each day of
the patient's stay, to clarify why the patient's per diem rate changes
for certain days of the stay. As illustrated in Table 11, SNF XYZ's
total PPS payment for this particular patient's stay would equal
$19,992.80.
[[Page 17631]]
Table 9--PDPM Case-Mix Adjusted Rate Computation Example
[Per diem rate calculation]
----------------------------------------------------------------------------------------------------------------
VPD adjustment VPD adjustment
Component Component group Component rate factor rate
----------------------------------------------------------------------------------------------------------------
PT.................................... TN...................... $90.52 1.00 $90.52
OT.................................... TN...................... 85.40 1.00 85.40
SLP................................... SH...................... 65.29 .............. 65.29
Nursing............................... CBC2.................... 165.29 .............. 165.29
NTA................................... NC...................... 148.03 3.00 444.09
Non-Case-Mix.......................... ........................ 95.48 .............. 95.48
-----------------------------------------------
Total PDPM Case-Mix Adj. Per Diem. ........................ .............. .............. 946.07
----------------------------------------------------------------------------------------------------------------
Table 10--Wage Index Adjusted Rate Computation Example
[PDPM wage index adjustment calculation]
--------------------------------------------------------------------------------------------------------------------------------------------------------
PDPM case-mix Total case mix
HIPPS code adjusted per Labor portion Wage index Wage index Non-labor and wage index
diem adjusted rate portion adj. rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
NHNC1............................................. $946.07 $669.82 0.9757 $653.54 $276.25 $929.79
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 11--Adjusted Rate Computation Example
----------------------------------------------------------------------------------------------------------------
Case mix and
NTA VPD PT/OT VPD wage index
Day of stay adjustment adjustment adjusted per
factor factor diem rate
----------------------------------------------------------------------------------------------------------------
1............................................................... 3.0 1.0 $929.79
2............................................................... 3.0 1.0 929.79
3............................................................... 3.0 1.0 929.79
4............................................................... 1.0 1.0 638.83
5............................................................... 1.0 1.0 638.83
6............................................................... 1.0 1.0 638.83
7............................................................... 1.0 1.0 638.83
8............................................................... 1.0 1.0 638.83
9............................................................... 1.0 1.0 638.83
10.............................................................. 1.0 1.0 638.83
11.............................................................. 1.0 1.0 638.83
12.............................................................. 1.0 1.0 638.83
13.............................................................. 1.0 1.0 638.83
14.............................................................. 1.0 1.0 638.83
15.............................................................. 1.0 1.0 638.83
16.............................................................. 1.0 1.0 638.83
17.............................................................. 1.0 1.0 638.83
18.............................................................. 1.0 1.0 638.83
19.............................................................. 1.0 1.0 638.83
20.............................................................. 1.0 1.0 638.83
21.............................................................. 1.0 0.98 635.37
22.............................................................. 1.0 0.98 635.37
23.............................................................. 1.0 0.98 635.37
24.............................................................. 1.0 0.98 635.37
25.............................................................. 1.0 0.98 635.37
26.............................................................. 1.0 0.98 635.37
27.............................................................. 1.0 0.98 635.37
28.............................................................. 1.0 0.96 631.91
29.............................................................. 1.0 0.96 631.91
30.............................................................. 1.0 0.96 631.91
-----------------------------------------------
Total Payment............................................... .............. .............. 19,992.80
----------------------------------------------------------------------------------------------------------------
IV. Additional Aspects of the SNF PPS
A. SNF Level of Care--Administrative Presumption
The establishment of the SNF PPS did not change Medicare's
fundamental requirements for SNF coverage. However, because the case-
mix classification is based, in part, on the beneficiary's need for
skilled nursing care and therapy, we have attempted, where possible, to
coordinate claims review procedures with the existing resident
assessment process and case-mix classification system discussed in
section III.C. of this proposed rule. This
[[Page 17632]]
approach includes an administrative presumption that utilizes a
beneficiary's correct assignment, at the outset of the SNF stay, to one
of the case-mix classifiers designated for this purpose to assist in
making certain SNF level of care determinations.
In accordance with the regulations at Sec. 413.345, we include in
each update of the federal payment rates in the Federal Register a
discussion of the resident classification system that provides the
basis for case-mix adjustment. Under that discussion, we designate
those specific classifiers under the case-mix classification system
that represent the required SNF level of care, as provided in Sec.
409.30. This designation reflects an administrative presumption that
those beneficiaries who are correctly assigned one of the designated
case-mix classifiers on the 5-day Medicare-required assessment are
automatically classified as meeting the SNF level of care definition up
to and including the assessment reference date (ARD) for that
assessment.
A beneficiary who does not qualify for the presumption is not
automatically classified as either meeting or not meeting the level of
care definition, but instead receives an individual determination on
this point using the existing administrative criteria. This presumption
recognizes the strong likelihood that those beneficiaries who are
assigned one of the designated case-mix classifiers during the
immediate post-hospital period would require a covered level of care,
which would be less likely for other beneficiaries.
In the July 30, 1999 final rule (64 FR 41670), we indicated that we
would announce any changes to the guidelines for Medicare level of care
determinations related to modifications in the case-mix classification
structure. The FY 2018 final rule (82 FR 36544) further specified that
we would henceforth disseminate the standard description of the
administrative presumption's designated groups via the SNF PPS website
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/ (where such designations appear in the paragraph
entitled ``Case Mix Adjustment''), and would publish such designations
in rulemaking only to the extent that we actually intend to make
changes in them. Under that approach, the set of case-mix classifiers
designated for this purpose under PDPM was finalized in the FY 2019 SNF
PPS final rule (83 FR 39253) and is posted on the SNF PPS website
(https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/), in the paragraph entitled ``Case Mix Adjustment.''
However, we note that this administrative presumption policy does
not supersede the SNF's responsibility to ensure that its decisions
relating to level of care are appropriate and timely, including a
review to confirm that any services prompting the assignment of one of
the designated case-mix classifiers (which, in turn, serves to trigger
the administrative presumption) are themselves medically necessary. As
we explained in the FY 2000 SNF PPS final rule (64 FR 41667), the
administrative presumption is itself rebuttable in those individual
cases in which the services actually received by the resident do not
meet the basic statutory criterion of being reasonable and necessary to
diagnose or treat a beneficiary's condition (according to section
1862(a)(1) of the Act). Accordingly, the presumption would not apply,
for example, in those situations where the sole classifier that
triggers the presumption is itself assigned through the receipt of
services that are subsequently determined to be not reasonable and
necessary. Moreover, we want to stress the importance of careful
monitoring for changes in each patient's condition to determine the
continuing need for Part A SNF benefits after the ARD of the 5-day
assessment. Finally, regarding the new set of case-mix classifiers
designated under the PDPM for this purpose, we noted in the FY 2019 SNF
PPS final rule (83 FR 39253, August 8, 2018) our intent ``. . . to
review the new designations going forward and make further adjustments
over time as we gain actual operating experience under the new
classification model.'' Accordingly, to the extent that it may become
evident in actual practice that these new criteria are not accurately
performing their intended role (for example, by capturing cases that do
not actually require an SNF level of care), we would propose
appropriate adjustments to correct them.
B. Consolidated Billing
Sections 1842(b)(6)(E) and 1862(a)(18) of the Act (as added by
section 4432(b) of the BBA 1997) require a SNF to submit consolidated
Medicare bills to its Medicare Administrative Contractor (MAC) for
almost all of the services that its residents receive during the course
of a covered Part A stay. In addition, section 1862(a)(18) of the Act
places the responsibility with the SNF for billing Medicare for
physical therapy, occupational therapy, and speech-language pathology
services that the resident receives during a noncovered stay. Section
1888(e)(2)(A) of the Act excludes a small list of services from the
consolidated billing provision (primarily those services furnished by
physicians and certain other types of practitioners), which remain
separately billable under Part B when furnished to a SNF's Part A
resident. These excluded service categories are discussed in greater
detail in section V.B.2. of the May 12, 1998 interim final rule (63 FR
26295 through 26297).
A detailed discussion of the legislative history of the
consolidated billing provision is available on the SNF PPS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Legislative_History_2018-10-01.pdf. In particular, section
103 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act
of 1999 (BBRA, Pub. L. 106-113, enacted on November 29, 1999) amended
section 1888(e)(2)(A) of the Act by further excluding a number of
individual high-cost, low probability services, identified by
Healthcare Common Procedure Coding System (HCPCS) codes, within several
broader categories (chemotherapy items, chemotherapy administration
services, radioisotope services, and customized prosthetic devices)
that otherwise remained subject to the provision. We discuss this BBRA
amendment in greater detail in the SNF PPS proposed and final rules for
FY 2001 (65 FR 19231 through 19232, April 10, 2000, and 65 FR 46790
through 46795, July 31, 2000), as well as in Program Memorandum AB-00-
18 (Change Request #1070), issued March 2000, which is available online
at www.cms.gov/transmittals/downloads/ab001860.pdf.
As explained in the FY 2001 proposed rule (65 FR 19232), the
amendments enacted in section 103 of the BBRA not only identified for
exclusion from this provision a number of particular service codes
within four specified categories (that is, chemotherapy items,
chemotherapy administration services, radioisotope services, and
customized prosthetic devices), but also gave the Secretary the
authority to designate additional, individual services for exclusion
within each of the specified service categories. In the proposed rule
for FY 2001, we also noted that the BBRA Conference report (H.R. Rep.
No. 106-479 at 854 (1999) (Conf. Rep.)) characterizes the individual
services that this legislation targets for exclusion as high-cost, low
probability events that could have devastating financial impacts
because their costs far exceed the payment SNFs receive under the PPS.
According to the conferees, section 103(a) of the BBRA is an attempt to
exclude from the PPS certain services
[[Page 17633]]
and costly items that are provided infrequently in SNFs. By contrast,
the amendments enacted in section 103 of the BBRA do not designate for
exclusion any of the remaining services within those four categories
(thus, leaving all of those services subject to SNF consolidated
billing), because they are relatively inexpensive and are furnished
routinely in SNFs.
As we further explained in the final rule for FY 2001 (65 FR
46790), and as is consistent with our longstanding policy, any
additional service codes that we might designate for exclusion under
our discretionary authority must meet the same statutory criteria used
in identifying the original codes excluded from consolidated billing
under section 103(a) of the BBRA: they must fall within one of the four
service categories specified in the BBRA; and they also must meet the
same standards of high cost and low probability in the SNF setting, as
discussed in the BBRA Conference report. Accordingly, we characterized
this statutory authority to identify additional service codes for
exclusion as essentially affording the flexibility to revise the list
of excluded codes in response to changes of major significance that may
occur over time (for example, the development of new medical
technologies or other advances in the state of medical practice) (65 FR
46791). In this proposed rule, we specifically invite public comments
identifying HCPCS codes in any of these four service categories
(chemotherapy items, chemotherapy administration services, radioisotope
services, and customized prosthetic devices) representing recent
medical advances that might meet our criteria for exclusion from SNF
consolidated billing. We may consider excluding a particular service if
it meets our criteria for exclusion as specified above. Commenters
should identify in their comments the specific HCPCS code that is
associated with the service in question, as well as their rationale for
requesting that the identified HCPCS code(s) be excluded.
We note that the original BBRA amendment (as well as the
implementing regulations) identified a set of excluded services by
means of specifying HCPCS codes that were in effect as of a particular
date (in that case, as of July 1, 1999). Identifying the excluded
services in this manner made it possible for us to utilize program
issuances as the vehicle for accomplishing routine updates of the
excluded codes, to reflect any minor revisions that might subsequently
occur in the coding system itself (for example, the assignment of a
different code number to the same service). Accordingly, in the event
that we identify through the current rulemaking cycle any new services
that would actually represent a substantive change in the scope of the
exclusions from SNF consolidated billing, we would identify these
additional excluded services by means of the HCPCS codes that are in
effect as of a specific date (in this case, as of October 1, 2019). By
making any new exclusions in this manner, we could similarly accomplish
routine future updates of these additional codes through the issuance
of program instructions.
C. Payment for SNF-Level Swing-Bed Services
Section 1883 of the Act permits certain small, rural hospitals to
enter into a Medicare swing-bed agreement, under which the hospital can
use its beds to provide either acute- or SNF-level care, as needed. For
critical access hospitals (CAHs), Part A pays on a reasonable cost
basis for SNF-level services furnished under a swing-bed agreement.
However, in accordance with section 1888(e)(7) of the Act, SNF-level
services furnished by non-CAH rural hospitals are paid under the SNF
PPS, effective with cost reporting periods beginning on or after July
1, 2002. As explained in the FY 2002 final rule (66 FR 39562), this
effective date is consistent with the statutory provision to integrate
swing-bed rural hospitals into the SNF PPS by the end of the transition
period, June 30, 2002.
Accordingly, all non-CAH swing-bed rural hospitals have now come
under the SNF PPS. Therefore, all rates and wage indexes outlined in
earlier sections of this final rule for the SNF PPS also apply to all
non-CAH swing-bed rural hospitals. As finalized in the FY 2010 SNF PPS
final rule (74 FR 40356 through 40357), effective October 1, 2010, non-
CAH swing-bed rural hospitals are required to complete an MDS 3.0
swing-bed assessment which is limited to the required demographic,
payment, and quality items. As discussed in the FY 2019 SNF PPS final
rule (83 FR 39235), revisions were made to the swing bed assessment in
order to support implementation of PDPM, effective October 1, 2019. A
discussion of the assessment schedule and the MDS effective beginning
FY 2020 appears in the FY 2019 SNF PPS final rule (83 FR 39229 through
39237). The latest changes in the MDS for swing-bed rural hospitals
appear on the SNF PPS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/.
V. Issues Relating to PDPM Implementation
A. Revised Group Therapy Definition
As set forth in the FY 2019 SNF PPS final rule (83 FR 39162),
effective October 1, 2019 under the PDPM, patients will be classified
into case-mix groups under each therapy component based on patient
characteristics rather than using the volume of therapy services
furnished to the patient as the basis for classification. Additionally,
as discussed in the FY 2019 SNF PPS final rule (83 FR 39237 through
39243), we finalized a combined limit on concurrent and group therapy
furnished to a patient, specifically that, for each therapy discipline,
no more than 25 percent of the therapy services furnished to a patient
in a covered Medicare Part A stay may be in a group or concurrent
setting. Given these policy changes relating to therapy classification
and therapy provision under the PDPM, as well as recent efforts to
increase standardization across PAC settings, we believed it was
appropriate to evaluate other policies associated with therapy under
PDPM to determine if other policies should be revised as well.
In the FY 2012 SNF PPS final rule (76 FR 48511 through 48517), we
finalized changes relating to the definition of group therapy and
payment of group therapy services, specifically to define group therapy
as the practice of one therapist or therapy assistant treating four
patients at the same time while the patients are performing either the
same or similar activities. In the FY 2012 SNF PPS final rule (76 FR
48511), we noted that, using our STRIVE data as a baseline, we
identified under RUG-IV two significant changes in provider behavior
related to the provision of therapy services to Medicare beneficiaries
in SNFs. First, we saw a major decrease in the amount of concurrent
therapy (that is therapy provided to two patients by one therapist or
therapy assistant doing different activities) performed in SNFs, the
minutes for which are divided between the two concurrent therapy
participants when determining the patient's appropriate RUG
classification. At the same time, we found a significant increase in
the amount of group therapy services, which were not subject to the
allocation requirement. Given this increase in group therapy services,
we expressed concern that the method for reporting group therapy on the
MDS created an inappropriate payment incentive to perform the group
therapy in place of individual therapy, because the method of reporting
group therapy
[[Page 17634]]
time did not require allocation among patients.
As we stated in the FY 2012 SNF PPS final rule (76 FR 48511),
because in group therapy, patients are performing similar activities,
in contrast to concurrent therapy, group therapy gives patients the
opportunity to benefit from each other's therapy regimen by observing
and interacting with one another and applying the lessons learned from
others to one's own therapy program in order to progress. At that time,
we stated that large groups, such as those of five or more
participants, can make it difficult for the participants to engage with
one another over the course of the session. In addition, we have long
believed that individual therapists could not adequately supervise
large groups, and since the inception of the SNF PPS in July 1998, we
have capped the number of residents at four. Furthermore, we believed
that groups of fewer than four participants did not maximize the group
therapy benefit for the participants. As we stated in the FY 2012 final
rule (76 FR 48511), we believed that in groups of two or three
participants, the opportunities for patients in the group to interact
and learn from each other are significantly diminished given the small
size of the group. Thus, we revised the definition of group therapy to
require a group size for the SNF setting of exactly four patients,
which we believed was the size that permits the therapy participants to
derive the maximum benefit from the group therapy setting.
Since that time, we have monitored group therapy utilization and
found that, as discussed in the FY 2019 SNF PPS final rule (83 FR 39237
through 39238), group therapy represents a very small proportion of
therapy provided to SNF patients. Further, as discussed in the FY 2019
SNF PPS final rule (83 FR 39240 through 39241), some commenters
suggested that we revise the definition of group therapy to include two
to six participants doing the same or similar activities, as this would
better align with the Inpatient Rehabilitation Facility (IRF) setting
and allow increased flexibility so that patients in smaller SNFs,
presumably where a group of exactly four patients may be difficult to
attain, could utilize and benefit from group therapy. In our response
to these comments, in the FY 2019 SNF PPS final rule (83 FR 39241), we
stated that we may consider changing the definition of group therapy in
future rulemaking. In the past we stated our concern that a group that
consisted of more than 4 participants would not allow for adequate
supervision of each participant as well as cause difficulty for
participants to engage with one another in the most effective way.
Conversely, we maintained that a group of fewer than 4 participants
would not allow for effective interaction to best achieve the goals of
a group. For these reasons, we defined group therapy as exactly 4
participants. However, based on our review of the use of group therapy
in the IRF and outpatient settings where the definition of group
therapy is less restrictive than the current definition under the SNF
PPS, we have found that therapists do seem capable of managing groups
of various sizes. Based on this review, we believe therapists have the
clinical judgment to determine whether groups of different sizes would
clinically benefit their patients, which they should be able to
demonstrate with adequate documentation. Patients can often benefit
from the psycho-social aspect of groups, and in some situations, a
group of six participants is not too large to provide that benefit to
participants. For example, a cooking activity which will provide very
functional therapy for patients planning to return home can be done in
a group of six that will enhance the patient's psycho-social experience
in the SNF. Alternatively, a group of 2-3 patients can be clinically
useful for certain patients as well. For example, a group of 2-3
patients who have pragmatic language difficulties following a stroke or
head injury could very well benefit from a small communication group to
work on the social aspects of language together without the concern of
distraction that a larger group might cause. Thus, while we continue to
maintain minimal concerns that some groups may be either too small or
too large to allow for effective interaction, we believe that the
potential clinical benefits of various size groups outweigh our
concerns, and that it would be appropriate to allow therapists greater
flexibility to perform therapy in groups of different sizes.
In light of our discussion above and the comments in the FY 2019
SNF PPS final rule, and to align the SNF PPS more closely with other
settings, in this proposed rule, we propose to adopt a new definition
of group therapy for use under PDPM, effective October 1, 2019, as
further discussed below.
In an effort to support CMS' cross-setting initiatives under the
IMPACT Act and Meaningful Measures Initiative, we have looked at ways
to align the definition of group therapy used under the SNF PPS more
closely with the definitions used within the outpatient setting covered
under Medicare Part B and under the IRF PPS, as this type of
standardization would reduce administrative burden on providers by
utilizing the same or similar definitions across settings. For group
therapy in the outpatient setting, the Medicare Benefit Policy Manual,
Chapter 15, Section 230 states that contractors pay for outpatient
physical therapy services (which includes outpatient speech-language
pathology services) and outpatient occupational therapy services
provided simultaneously to two or more individuals by a practitioner as
group therapy services (CPT code 97150). This manual section further
states that the individuals can be, but need not be, performing the
same activity. In addition, this section states that the physician or
therapist involved in group therapy services must be in constant
attendance, but one-on-one patient contact is not required. Under the
IRF PPS, the definition of group therapy (found in Section 2 of the IRF
PAI Training Manual, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/IRFPAI-1_5-2_0.zip) is
the provision of therapy services by one licensed or certified
therapist (or licensed therapy assistant, under the appropriate
direction of a licensed or certified therapist) treating two to six
patients at the same time who are performing the same or similar
activities.
We considered using the same definition as used in the outpatient
setting covered under Medicare Part B, which is two or more patients
performing either the same or different activity, as opposed to the IRF
definition of two to six patients performing the same or similar
activities. However, given the greater degree of similarity between the
IRF and SNF settings in terms of the intensity of therapy and patient
acuity, we believe that the IRF PPS definition would be more
appropriate in the SNF setting.
Accordingly, for the reasons discussed previously, we are proposing
to define group therapy in the SNF Part A setting as a qualified
rehabilitation therapist or therapy assistant treating two to six
patients at the same time who are performing the same or similar
activities. We believe this definition would offer therapists more
clinical flexibility when determining the appropriate number for a
group, without compromising the therapist's ability to manage the group
and the patient's ability to interact effectively and benefit from
group therapy.
[[Page 17635]]
We continue to believe that individual therapy is the preferred
mode of therapy provision and offers the most tailored service for
patients. As we stated in the FY 2012 proposed rule (76 FR 26387),
while group therapy can play an important role in SNF patient care,
group therapy is not appropriate for either all patients or for all
conditions, and is primarily effective as a supplement to individual
therapy, which we maintain should be considered the primary therapy
mode and standard of care in therapy services provided to SNF
residents.
Additionally, we continue to maintain that when group therapy is
used in a SNF, therapists must document its use in order to demonstrate
why it is the most appropriate mode of therapy for the patient who is
receiving it. As stated in the FY 2012 proposed rule (76 FR 26388)
regarding group therapy documentation, because group therapy is not
appropriate for either all patients or all conditions, and in order to
verify that group therapy is medically necessary and appropriate to the
needs of each beneficiary, SNFs should include in the patient's plan of
care an explicit justification for the use of group, rather than
individual or concurrent, therapy. This description should include, but
need not be limited to, the specific benefits to that particular
patient of including the documented type and amount of group therapy;
that is, how the prescribed type and amount of group therapy will meet
the patient's needs and assist the patient in reaching the documented
goals. In addition, we believe that the above documentation is
necessary to demonstrate that the SNF is providing services to attain
or maintain the highest practicable physical, mental, and psychosocial
well-being of each resident in accordance with section 1819(b)(2) of
the Act.
B. Updating ICD-10 Code Mappings and Lists
In the FY 2019 SNF PPS final rule (83 FR 39162), we finalized the
implementation of PDPM, effective October 1, 2019. The PDPM utilizes
ICD-10 codes in several ways, including to assign patients to clinical
categories used for categorization in the PT, OT, and SLP components,
as well as identifying certain comorbidities relevant for
classification under the SLP and NTA components. The ICD-10 mappings
and lists that would be used under PDPM, once implemented, are
available on the PDPM website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html.
Each year, the ICD-10 Coordination and Maintenance Committee, a
federal interdepartmental committee that is chaired by representatives
from the National Center for Health Statistics (NCHS) and by
representatives from CMS, meets biannually and publishes updates to the
ICD-10 medical code data sets in June of each year. These changes
become effective October 1 of the year in which these updates are
issued by the committee. The ICD-10 Coordination and Maintenance
Committee also has the ability to make changes to the ICD-10 medical
code data sets effective on April 1, but has not yet done so.
As providers are required to follow the most up to date coding
guidance issued by this committee in accordance with 45 CFR part 162,
subpart J, it is essential that we be able to update our code mappings
and lists consistent with the latest coding guidance. Therefore, to
ensure that the ICD-10 mappings and lists used under PDPM reflect the
most up to date codes possible, we propose to update any ICD-10 code
mappings and lists used under PDPM, as well as the SNF GROUPER software
and other such products related to patient classification and billing,
through a subregulatory process which would consist of posting updated
code mappings and lists on the PDPM website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html. More
specifically, beginning with the updates for FY 2020 (see discussion
below), nonsubstantive changes to the ICD-10 codes included on the code
mappings and lists under the PDPM would be applied through the
subregulatory process described above, and substantive revisions to the
ICD-10 codes on the code mappings and lists used under the PDPM would
be proposed and finalized through notice and comment rulemaking.
Nonsubstantive changes would be limited to those specific changes
that are necessary to maintain consistency with the most current ICD-10
medical code data set, which Medicare providers are generally required
to use. Our intent in applying these nonsubstantive changes through the
proposed subregulatory process would be to keep the same conditions in
the PDPM clinical categories and comorbidities lists, but ensure that
the codes used to identify those conditions are synchronized with the
most current ICD-10 medical code data set. For example, to the extent
that the ICD-10-CM Coordination and Maintenance Committee changes an
ICD-10 code for a comorbid condition on our comorbidities lists into
one or more codes that provide additional detail, we would update the
SNF GROUPER software and ICD-10 mappings and lists on the CMS website
to reflect the new codes through the subregulatory process proposed
above. By contrast, we would use notice and comment rulemaking to make
substantive changes to the ICD-10 code mappings and lists under the
PDPM. For the purposes of this policy, a substantive change would be
defined simply as any change that does not fall within the definition
of a nonsubstantive change--that is, changes that go beyond the
intention of maintaining consistency with the most current ICD-10
medical code data set. For instance, changes to the assignment of a
code to a comorbidity list or other changes that amount to changes in
policy would be substantive changes. Taking the example above, there
may be situations in which the addition of one or more of these new
codes to the list of comorbidities may not be appropriate. For example,
the ICD-10 code for a particular condition is divided into two more
detailed codes, one of which represents a condition that generally is
predictive of the costs of care in a SNF and one of which is not. We
would propose through notice and comment rulemaking to delete the code
that does not reflect increased costs of care in a SNF from the list of
comorbidities in the SNF GROUPER software because removing the code
would constitute a substantive change. We propose to indicate all
changes to codes in the GROUPER software by posting a complete ICD-10
mapping table, including new, discontinued, and modified codes, on the
PDPM website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html. We also propose to report the complete list
of ICD-10 codes associated with the SNF PDPM clinical categories and
SLP/NTA comorbidities in the SNF GROUPER documentation, which is also
posted on the PDPM website. All changes would be included in these
documents, with substantive changes being included only after being
finalized through notice and comment rulemaking.
We believe that the proposed subregulatory update process (by which
nonsubstantive changes to the ICD-10 code mappings and lists used under
PDPM as well as the SNF GROUPER software and other such products
related to patient classification and billing would be posted on the
CMS websites specified above), is the best way for us to convey
information about changes to the ICD-10 medical code
[[Page 17636]]
data set that affect the code mappings and lists used under the PDPM.
We believe the proposed subregulatory process would help ensure
providers have the most up-to-date information as soon as possible, in
the clearest and most useful format, as opposed to publishing each
nonsubstantive change to the ICD-10 codes in a rule after notice and
comment rulemaking.
Additionally, the proposed subregulatory process is in alignment
with similar policies in the SNF PPS and the IRF PPS settings. For
example, the SNF PPS already uses a subregulatory process to make
nonsubstantive updates to the list of Healthcare Common Procedure
Coding System (HCPCS) codes that are subject to the consolidated
billing (CB) provision of the SNF PPS. We post routine annual updates
to the lists of codes that are included or excluded from CB on the SNF
CB website at https://www.cms.gov/Medicare/Billing/SNFConsolidatedBilling/. The new codes identified in each
update describe the same services that are subject to SNF PPS CB. No
additional services are added by these routine updates; that is, these
updates are necessary because of changes to the coding system, not
because the services subject to SNF CB are being redefined. We believe
the proposed subregulatory process to update ICD-10 codes associated
with PDPM clinical categories and comorbidity lists is appropriate
given that it is consistent with this subregulatory process already in
use under the SNF PPS to make nonsubstantive coding updates.
Likewise, the IRF PPS also utilizes processes similar to that
proposed here. In the FY 2007 IRF PPS final rule (71 FR 48360 through
48361), we implemented a similar subregulatory updating process for the
IRF tier comorbidities list, and the FY 2018 IRF PPS final rule (82 FR
36267 through 36269) established a similar process for updating the
ICD-10 code lists used for the IRF presumptive compliance methodology.
Both the IRF tier comorbidities list and the IRF presumptive compliance
methodology also use ICD-10 codes. Therefore, we believe the
subregulatory process proposed in this rule is appropriate because it
is also consistent with processes used in another Medicare setting.
We are proposing that this subregulatory process for updating the
ICD-10 codes used under the PDPM would take effect beginning with the
updates for FY 2020. The proposed ICD-10 code mappings and lists for
use under the PDPM are available for download from the SNF PPS website
(https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html). These mappings and lists reflect the adoption of the ICD-10
Coordination and Maintenance Committee's draft changes to the ICD-10
medical code data sets, effective October 1, 2018. The version of these
mappings and lists that is finalized in conjunction with the FY 2020
SNF PPS final rule would constitute the baseline for any future updates
to the mappings and lists using the proposed process above.
C. Revisions to the Regulation Text
Along with our proposed revisions as discussed elsewhere in this
proposed rule, we are also proposing to make certain revisions to the
regulations text itself to reflect the revised assessment schedule
under the PDPM, as finalized in the FY 2019 SNF PPS final rule (83 FR
39229). Specifically, we propose to revise the prescribed PPS
assessment schedule as set forth in Sec. 413.343(b), to reflect the
elimination, upon the conversion from RUG-IV to PDPM on October 1,
2019, of all scheduled assessments after the initial 5-day, Medicare-
required assessment. We note that even though this assessment is
commonly referred to as the ``5-day'' assessment (reflecting its
original 5-day assessment window), an additional 3 grace days have
always been available beyond that window for its actual completion.
Further, because those additional 3 grace days will be directly
incorporated into the assessment window itself effective October 1,
2019 (as finalized in the FY 2019 SNF PPS final rule (83 FR 39231,
39232, and 39234)), thus resulting in an overall 8-day assessment
window, we additionally propose to include a conforming revision in
Sec. 413.343(b) to make clear that the actual deadline for completing
this assessment is no later than the 8th day of posthospital SNF care.
In addition, because under the PDPM, there is only one scheduled
patient assessment, we also propose to replace the phrase ``patient
assessments'' in Sec. 413.343(b) with the phrase ``an initial patient
assessment.'' Accordingly, we propose to revise Sec. 413.343(b) to
state that the assessment schedule must include performance of an
initial patient assessment no later than the 8th day of posthospital
SNF care.
We further propose to revise the existing language in Sec.
413.343(b) that additionally requires the completion of ``such other
assessments that are necessary to account for changes in patient care
needs,'' to state ``such other interim payment assessments as the SNF
determines are necessary to account for changes in patient care
needs.'' As we finalized in the FY 2019 SNF PPS final rule (83 FR 39230
through 39234), the optional Interim Payment Assessment (IPA) will
serve as the instrument for conducting assessments under the PDPM that
the SNF determines are necessary after the completion of the 5-day,
Medicare-required assessment to address clinical changes throughout a
SNF stay. We believe that our proposed language is consistent with the
expectation expressed in the FY 2019 SNF PPS final rule for SNFs ``. .
. to provide excellent skilled nursing and rehabilitative care and
continually monitor and document patient status'' (83 FR 39233), and
makes clear that the SNF's responsibility in this context would include
recognizing those situations that warrant a decision to complete an IPA
in order to account appropriately for a change in patient status.
Finally, to ensure consistency, we also propose to make a conforming
revision to the regulations text in the introductory paragraph of Sec.
409.30, so that it would use the same terminology of ``initial patient
assessment'' as would appear in revised Sec. 413.343(b). Specifically,
in the introductory paragraph of Sec. 409.30, we would replace the
phrase ``the 5-day assessment'' with ``the initial patient
assessment.'' We note that the regulations text in the introductory
paragraph of Sec. 409.30 would continue to specify that the assessment
reference date (ARD) for this assessment must occur no later than the
8th day of posthospital SNF care, consistent with the instructions set
forth in sections 2.8 and 2.9 of the RAI Version 3.0 Manual.
VI. Other Issues
A. Skilled Nursing Facility (SNF) Quality Reporting Program (QRP)
1. Background
The Skilled Nursing Facility Quality Reporting Program (SNF QRP) is
authorized by section 1888(e)(6) of the Act and it applies to
freestanding SNFs, SNFs affiliated with acute care facilities, and all
non-CAH swing-bed rural hospitals. Under the SNF QRP, the Secretary
must reduce by 2 percentage points the annual market basket percentage
update described in section 1888(e)(5)(B)(i) of the Act applicable to a
SNF for a fiscal year, after application of section 1888(e)(5)(B)(ii)
of the Act (the MFP adjustment) and section 1888(e)(5)(B)(iii) of the
Act, in the case of a SNF that does not submit data in accordance with
sections 1888(e)(6)(B)(i) of the Act for that fiscal year. For more
information on the
[[Page 17637]]
requirements we have adopted for the SNF QRP, we refer readers to the
FY 2016 SNF PPS final rule (80 FR 46427 through 46429), FY 2017 SNF PPS
final rule (81 FR 52009 through 52010), FY 2018 SNF PPS final rule (82
FR 36566), and FY 2019 SNF PPS final rule (83 FR 39162 through 39272).
2. General Considerations Used for the Selection of Measures for the
SNF QRP
For a detailed discussion of the considerations we historically
used for the selection of SNF QRP quality, resource use, and other
measures, we refer readers to the FY 2016 SNF PPS final rule (80 FR
46429 through 46431).
3. Quality Measures Currently Adopted for the FY 2021 SNF QRP
The SNF QRP currently has 11 measures for the FY 2021 SNF QRP,
which are set out in Table 12.
Table 12--Quality Measures Currently Adopted for the FY 2021 SNF QRP
------------------------------------------------------------------------
Short name Measure name & data source
------------------------------------------------------------------------
Resident Assessment Instrument Minimum Data Set
------------------------------------------------------------------------
Pressure Ulcer/Injury............. Changes in Skin Integrity Post-Acute
Care: Pressure Ulcer/Injury.
Application of Falls.............. Application of Percent of Residents
Experiencing One or More Falls with
Major Injury (Long Stay) (NQF
#0674).
Application of Functional Application of Percent of Long-Term
Assessment/Care Plan. Care Hospital (LTCH) Patients with
an Admission and Discharge
Functional Assessment and a Care
Plan That Addresses Function (NQF
#2631).
Change in Mobility Score.......... Application of IRF Functional
Outcome Measure: Change in Mobility
Score for Medical Rehabilitation
Patients (NQF #2634).
Discharge Mobility Score.......... Application of IRF Functional
Outcome Measure: Discharge Mobility
Score for Medical Rehabilitation
Patients (NQF #2636).
Change in Self-Care Score......... Application of the IRF Functional
Outcome Measure: Change in Self-
Care Score for Medical
Rehabilitation Patients (NQF
#2633).
Discharge Self-Care Score......... Application of IRF Functional
Outcome Measure: Discharge Self-
Care Score for Medical
Rehabilitation Patients (NQF
#2635).
DRR............................... Drug Regimen Review Conducted With
Follow-Up for Identified Issues-
Post Acute Care (PAC) Skilled
Nursing Facility (SNF) Quality
Reporting Program (QRP).
------------------------------------------------------------------------
Claims-Based
------------------------------------------------------------------------
MSPB SNF.......................... Medicare Spending Per Beneficiary
(MSPB)-Post Acute Care (PAC)
Skilled Nursing Facility (SNF)
Quality Reporting Program (QRP).
DTC............................... Discharge to Community (DTC)-Post
Acute Care (PAC) Skilled Nursing
Facility (SNF) Quality Reporting
Program (QRP).
PPR............................... Potentially Preventable 30-Day Post-
Discharge Readmission Measure for
Skilled Nursing Facility (SNF)
Quality Reporting Program (QRP).
------------------------------------------------------------------------
4. SNF QRP Quality Measure Proposals Beginning With the FY 2022 SNF QRP
In this proposed rule, we are proposing to adopt two process
measures for the SNF QRP that, as required by section
1888(e)(6)(B)(i)(II) of the Act, would satisfy section
1899B(c)(1)(E)(ii) of the Act, which requires that the quality measures
specified by the Secretary include measures with respect to the quality
measure domain titled ``Accurately communicating the existence of and
providing for the transfer of health information and care preferences
of an individual to the individual, family caregiver of the individual,
and providers of services furnishing items and services to the
individual when the individual transitions from a post-acute care (PAC)
provider to another applicable setting, including a different PAC
provider, a hospital, a critical access hospital, or the home of the
individual.'' Given the length of this domain title, hereafter, we will
refer to this quality measure domain as ``Transfer of Health
Information.''
The two measures we are proposing to adopt are: (1) Transfer of
Health Information to the Provider-Post-Acute Care (PAC); and (2)
Transfer of Health Information to the Patient-Post-Acute Care (PAC).
Both of these proposed measures support our Meaningful Measures
priority of promoting effective communication and coordination of care,
specifically the Meaningful Measure area of the transfer of health
information and interoperability.
In addition to the two measure proposals, we are proposing to
update the specifications for the Discharge to Community--PAC SNF QRP
measure to exclude baseline nursing facility (NF) residents from the
measure.
We are seeking public comment on each of these proposals.
a. Proposed Transfer of Health Information to the Provider-Post-Acute
Care (PAC) Measure
The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) Measure is a process-based measure that assesses
whether or not a current reconciled medication list is given to the
subsequent provider when a patient is discharged or transferred from
his or her current PAC setting.
(1) Background
In 2013, 22.3 percent of all acute hospital discharges were
discharged to PAC settings, including 11 percent who were discharged to
home under the care of a home health agency, and nine percent who were
discharged to SNFs.\1\ The proportion of patients being discharged from
an acute care hospital to a PAC setting was greater among beneficiaries
enrolled in Medicare fee-for-service (FFS). Among Medicare FFS patients
discharged from an acute hospital, 42 percent went directly to PAC
settings. Of that 42 percent, 20 percent were discharged to a SNF, 18
percent were discharged to a home health agency (HHA), 3 percent were
discharged to an IRF, and 1 percent were discharged to an LTCH.\2\ Of
the Medicare FFS beneficiaries with a SNF stay in FY 2017, an estimated
21 percent were discharged or transferred to an acute care hospital, 11
percent discharged home with home health
[[Page 17638]]
services, and two percent discharged or transferred to another PAC
setting (for example, an IRF, a hospice, or another SNF).\3\
---------------------------------------------------------------------------
\1\ Tian, W. ``An all-payer view of hospital discharge to post-
acute care,'' May 2016. Available at https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
\2\ Ibid.
\3\ RTI International analysis of Medicare claims data for index
stays in SNF 2017. (RTI program reference: IB55).
---------------------------------------------------------------------------
The transfer and/or exchange of health information from one
provider to another can be done verbally (for example, clinician-to-
clinician communication in-person or by telephone), paper-based (for
example, faxed or printed copies of records), and via electronic
communication (for example, through a health information exchange
network using an electronic health/medical record, and/or secure
messaging). Health information, such as medication information, that is
incomplete or missing increases the likelihood of a patient or resident
safety risk, and is often life-threatening.4 5
6 7 8 9 Poor communication
and coordination across health care settings contributes to patient
complications, hospital readmissions, emergency department visits, and
medication errors.10 11 12
13 14 15 16 17
18 19 Communication has been cited as the third
most frequent root cause in sentinel events, which The Joint Commission
\20\ defines as a patient safety event that results in death, permanent
harm, or severe temporary harm. Failed or ineffective patient handoffs
are estimated to play a role in 20 percent of serious preventable
adverse events.\21\ When care transitions are enhanced through care
coordination activities, such as expedited patient information flow,
these activities can reduce duplication of care services and costs of
care, resolve conflicting care plans, and prevent medical
errors.22 23 24 25
26
---------------------------------------------------------------------------
\4\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
\5\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
\6\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
\7\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
\8\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
\9\ Boling, P.A., ``Care transitions and home health care,''
Clinical Geriatric Medicine, 2009, Vol. 25(1), pp. 135-48.
\10\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of
medication information across settings--keeping it free from
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
\11\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
\12\ Jencks, S.F., Williams, M.V., & Coleman, E.A.,
``Rehospitalizations among patients in the Medicare fee-for-service
program,'' New England Journal of Medicine, 2009, Vol. 360(14), pp.
1418-1428.
\13\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at https://www.nap.edu/read/11623/chapter/1.
\14\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling approach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
\15\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
\16\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at https://www.nap.edu/read/11623/chapter/1.
\17\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling approach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
\18\ Forster, A.J., Murff, H.J., Peterson, J.F., Gandhi, T.K., &
Bates, D.W., ``The incidence and severity of adverse events
affecting patients after discharge from the hospital.'' Annals of
Internal Medicine, 2003,138(3), pp. 161-167.
\19\ King, B.J., Gilmore-Bykovskyi, A.L., Roiland, R.A.,
Polnaszek, B.E., Bowers, B.J., & Kind, A.J. ``The consequences of
poor communication during transitions from hospital to skilled
nursing facility: a qualitative study,'' Journal of the American
Geriatrics Society, 2013, Vol. 61(7), 1095-1102.
\20\ The Joint Commission, ``Sentinel Event Policy'' available
at https://www.jointcommission.org/sentinel_event_policy_and_procedures/.
\21\ The Joint Commission. ``Sentinel Event Data Root Causes by
Event Type 2004-2015.'' 2016. Available at https://www.jointcommission.org/assets/1/23/jconline_Mar_2_2016.pdf.
\22\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
\23\ Institute of Medicine, ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies
Press, 2007. Available at https://www.nap.edu/read/11623/chapter/1.
\24\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C.,
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner,
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and
preventable adverse events among hospitalized children following
implementation of a resident handoff bundle,'' JAMA, 2013, Vol.
310(21), pp. 2262-2270.
\25\ Pronovost, P., M.M.E. Johns, S. Palmer, R.C. Bono, D.B.
Fridsma, A. Gettinger, J. Goldman, W. Johnson, M. Karney, C. Samitt,
R.D. Sriram, A. Zenooz, and Y.C. Wang, Editors. Procuring
Interoperability: Achieving High-Quality, Connected, and Person-
Centered Care. Washington, DC, 2018. National Academy of Medicine.
Available at https://nam.edu/wp-content/uploads/2018/10/Procuring-Interoperability_web.pdf.
\26\ Balaban RB, Weissman JS, Samuel PA, & Woolhandler, S.,
``Redefining and redesigning hospital discharge to enhance patient
care: a randomized controlled study,'' J Gen Intern Med, 2008, Vol.
23(8), pp. 1228-33.
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Care transitions across health care settings have been
characterized as complex, costly, and potentially hazardous, and may
increase the risk for multiple adverse outcomes.27
28 The rising incidence of preventable adverse events,
complications, and hospital readmissions have drawn attention to the
importance of the timely transfer of health information and care
preferences at the time of transition. Failures of care coordination,
including poor communication of information, were estimated to cost the
U.S. health care system between $25 billion and $45 billion in wasteful
spending in 2011.\29\ The communication of health information and
patient care preferences is critical to ensuring safe and effective
transitions from one health care setting to another.30
31
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\27\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol 29(6), pp. 932-939.
\28\ Simmons, S., Schnelle, J., Slagle, J., Sathe, N.A.,
Stevenson, D., Carlo, M., & McPheeters, M.L., ``Resident safety
practices in nursing home settings.'' Technical Brief No. 24
(Prepared by the Vanderbilt Evidence-based Practice Center under
Contract No. 290-2015-00003-I.) AHRQ Publication No. 16-EHC022-EF.
Rockville, MD: Agency for Healthcare Research and Quality. May 2016.
Available at https://www.ncbi.nlm.nih.gov/books/NBK384624/.
\29\ Berwick, D.M. & Hackbarth, A.D. ``Eliminating Waste in US
Health Care,'' JAMA, 2012, Vol. 307(14), pp.1513-1516.
\30\ McDonald, K.M., Sundaram, V., Bravata, D.M., Lewis, R.,
Lin, N., Kraft, S.A. & Owens, D.K. Care Coordination. Vol. 7 of:
Shojania K.G., McDonald K.M., Wachter R.M., Owens D.K., editors.
``Closing the quality gap: A critical analysis of quality
improvement strategies.'' Technical Review 9 (Prepared by the
Stanford University-UCSF Evidence-based Practice Center under
contract 290-02-0017). AHRQ Publication No. 04(07)-0051-7.
Rockville, MD: Agency for Healthcare Research and Quality. June
2006. Available at https://www.ncbi.nlm.nih.gov/books/NBK44015/.
\31\ Lattimer, C., ``When it comes to transitions in patient
care, effective communication can make all the difference,''
Generations, 2011, Vol. 35(1), pp. 69-72.
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Patients in PAC settings often have complicated medication regimens
and require efficient and effective communication and coordination of
care between settings, including detailed transfer of medication
information.32 33 34 Individuals in
PAC
[[Page 17639]]
settings may be vulnerable to adverse health outcomes due to
insufficient medication information on the part of their health care
providers, and the higher likelihood for multiple comorbid chronic
conditions, polypharmacy, and complicated transitions between care
settings.35 36 Preventable adverse drug events
(ADEs) may occur after hospital discharge in a variety of settings
including PAC.\37\ A 2014 Office of Inspector General report found that
almost one-tenth of Medicare beneficiaries experienced an ADE, such as
delirium, bleeding, fall or injury, or constipation, during their stay
in a SNF in 2011. Of these, two-thirds were classified as
preventable.\38\ Medication errors and one-fifth of ADEs occur during
transitions between settings, including admission to or discharge from
a hospital to home or a PAC setting, or transfer between
hospitals.39 40
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\32\ Starmer A.J., Spector N.D., Srivastava R., West, D.C.,
Rosenbluth, G., Allen, A.D., Noble, E.L., & Landrigen, C.P.,
``Changes in medical errors after implementation of a handoff
program,'' N Engl J Med, 2014, Vol. 37(1), pp. 1803-1812.
\33\ Kruse, C.S. Marquez, G., Nelson, D., & Polomares, O., ``The
use of health information exchange to augment patient handoff in
long-term care: a systematic review,'' Applied Clinical Informatics,
2018, Vol. 9(4), pp. 752-771.
\34\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R., ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166 e170.
\35\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation
during the transition to and from long-term care settings: a
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
\36\ Levinson, D.R., & General, I., ``Adverse events in skilled
nursing facilities: national incidence among Medicare
beneficiaries.'' Washington, DC: U.S. Department of Health and Human
Services, Office of Inspector General, February 2014. Available at
https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
\37\ Battles J., Azam I., Grady M., & Reback K., ``Advances in
patient safety and medical liability,'' AHRQ Publication No. 17-
0017-EF. Rockville, MD: Agency for Healthcare Research and Quality,
August 2017. Available at https://www.ahrq.gov/sites/default/files/publications/files/advances-complete_3.pdf.
\38\ Health and Human Services Office of Inspector General.
Adverse events in skilled nursing facilities: National incidence
among Medicare beneficiaries. OEI-06-11-00370). 2014. Available at
https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
\39\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of
medication information across settings--keeping it free from
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
\40\ Gleason, K.M., Groszek, J.M., Sullivan, C., Rooney, D.,
Barnard, C., Noskin, G.A., ``Reconciliation of discrepancies in
medication histories and admission orders of newly hospitalized
patients,'' American Journal of Health System Pharmacy, 2004, Vol.
61(16), pp. 1689-1694.
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Patients in PAC settings are often taking multiple medications.
Consequently, PAC providers regularly are in the position of starting
complex new medication regimens with little knowledge of the patients
or their medication history upon admission. Furthermore, inter-facility
communication barriers delay resolving medication discrepancies during
transitions of care.\41\ Medication discrepancies are common,\42\ and
found to occur in 86 percent of all transitions, increasing the
likelihood of ADEs.43 44 45 Up to 90
percent of patients experience at least one medication discrepancy in
the transition from hospital to home care, and discrepancies occur
within all therapeutic classes of medications.46
47
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\41\ Patterson M., Foust J.B., Bollinger, S., Coleman, C.,
Nguyen, D., ``Inter-facility communication barriers delay resolving
medication discrepancies during transitions of care,'' Research in
Social & Administrative Pharmacy (2018), doi: 10.1016/
j.sapharm.2018.05.124.
\42\ Manias, E., Annaikis, N., Considine, J., Weerasuriya, R., &
Kusljic, S. ``Patient-, medication- and environment-related factors
affecting medication discrepancies in older patients,'' Collegian,
2017, Vol. 24, pp. 571-577.
\43\ Tjia, J., Bonner, A., Briesacher, B.A., McGee, S., Terrill,
E., Miller, K., ``Medication discrepancies upon hospital to skilled
nursing facility transitions,'' J Gen Intern Med, 2009, Vol. 24(5),
pp. 630-635.
\44\ Sinvani, L.D., Beizer, J., Akerman, M., Pekmezaris, R.,
Nouryan, C., Lutsky, L., Cal, C., Dlugacz, Y., Masick, K., Wolf-
Klein, G.,''Medication reconciliation in continuum of care
transitions: a moving target,'' J Am Med Dir Assoc, 2013, Vol.
14(9), 668-672.
\45\ Coleman E.A., Parry C., Chalmers S., & Min, S.J., ``The
Care Transitions Intervention: results of a randomized controlled
trial,'' Arch Intern Med, 2006, Vol. 166, pp. 1822-1828.
\46\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, l.D.,
``Nurse identified hospital to home medication discrepancies:
implications for improving transitional care,'' Geriatr Nurs, 2011,
Vol. 31(3), pp. 188-196.
\47\ Setter S.M., Corbett C.F., Neumiller J.J., Gates, B.J.,
Sclar, D.A., & Sonnett, T.E., ``Effectiveness of a pharmacist-nurse
intervention on resolving medication discrepancies in older patients
transitioning from hospital to home care: impact of a pharmacy/
nursing intervention,'' Am J Health Syst Pharm, 2009, Vol. 66, pp.
2027-2031.
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Transfer of a medication list between providers is necessary for
medication reconciliation interventions, which have been shown to be a
cost-effective way to avoid ADEs by reducing errors,48
49 50 especially when medications are reviewed by
a pharmacist using electronic medical records.\51\
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\48\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
\49\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
\50\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation
during the transition to and from long-term care settings: a
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
\51\ Agrawal A, Wu WY. ``Reducing medication errors and
improving systems reliability using an electronic medication
reconciliation system,'' The Joint Commission Journal on Quality and
Patient Safety, 2009, Vol. 35(2), pp. 106-114.
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(2) Stakeholder and Technical Expert Panel (TEP) Input
The proposed measure was developed after consideration of feedback
we received from stakeholders and four TEPs convened by our
contractors. Further, the proposed measure was developed after
evaluation of data collected during two pilot tests we conducted in
accordance with the CMS Measures Management System Blueprint.
Our measure development contractors constituted a TEP which met on
September 27, 2016,\52\ January 27, 2017, and August 3, 2017 \53\ to
provide input on a prior version of this measure. Based on this input,
we updated the measure concept in late 2017 to include the transfer of
a specific component of health information--medication information. Our
measure development contractors reconvened this TEP on April 20, 2018
for the purpose of obtaining expert input on the proposed measure,
including the measure's reliability, components of face validity, and
feasibility of being implemented across PAC settings. Overall, the TEP
was supportive of the proposed measure, affirming that the measure
provides an opportunity to improve the transfer of medication
information. A summary of the April 20, 2018 TEP proceedings titled
``Transfer of Health Information TEP Meeting 4-June 2018'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
[[Page 17640]]
Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-
of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
\52\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
\53\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
---------------------------------------------------------------------------
Our measure development contractors solicited stakeholder feedback
on the proposed measure by requesting comment on the CMS Measures
Management System Blueprint website, and accepted comments that were
submitted from March 19, 2018 to May 3, 2018. The comments received
expressed overall support for the measure. Several commenters suggested
ways to improve the measure, primarily related to what types of
information should be included at transfer. We incorporated this input
into development of the proposed measure. The summary report for the
March 19 to May 3, 2018 public comment period titled ``IMPACT
Medication-Profile-Transferred-Public-Comment-Summary-Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(3) Pilot Testing
The proposed measure was tested between June and August 2018 in a
pilot test that involved 24 PAC facilities/agencies, including five
IRFs, six SNFs, six LTCHs, and seven HHAs. The 24 pilot sites submitted
a total of 801 records. Analysis of agreement between coders within
each participating facility (266 qualifying pairs) indicated a 93-
percent agreement for this measure. Overall, pilot testing enabled us
to verify its reliability, components of face validity, and feasibility
of being implemented across PAC settings. Further, more than half of
the sites that participated in the pilot test stated during the
debriefing interviews that the measure could distinguish facilities or
agencies with higher quality medication information transfer from those
with lower quality medication information transfer at discharge. The
pilot test summary report titled ``Transfer of Health Information 2018
Pilot Test Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(4) Measure Applications Partnership (MAP) Review and Related Measures
We included the proposed measure in the SNF QRP section of the 2018
Measures Under Consideration (MUC) list. The MAP conditionally
supported this measure pending NQF endorsement, noting that the measure
can promote the transfer of important medication information. The MAP
also suggested that CMS consider a measure that can be adapted to
capture bi-directional information exchange, and recommended that the
medication information transferred include important information about
supplements and opioids. More information about the MAP's
recommendations for this measure is available at https://www.qualityforum.org/Publications/2019/02/MAP_2019_Considerations_for_Implementing_Measures_Final_Report_-_PAC-LTC.aspx.
As part of the measure development and selection process, we also
identified one NQF-endorsed quality measure similar to the proposed
measure, titled Documentation of Current Medications in the Medical
Record (NQF #0419, CMS eCQM ID: CMS68v8). This measure was adopted as
one of the recommended adult core clinical quality measures for
eligible professionals for the EHR Incentive Program beginning in 2014,
and was also adopted under the Merit-based Incentive Payment System
(MIPS) quality performance category beginning in 2017. The measure is
calculated based on the percentage of visits for patients aged 18 years
and older for which the eligible professional or eligible clinician
attests to documenting a list of current medications using all
resources immediately available on the date of the encounter.
The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) measure addresses the transfer of information whereas
the NQF-endorsed measure #0419 assesses the documentation of
medications, but not the transfer of such information. This is
important as the proposed measure assesses for the transfer of
medication information for the proposed measure calculation. Further,
the proposed measure utilizes standardized patient assessment data
elements (SPADEs), which is a requirement for measures specified under
the Transfer of Health Information measure domain under section
1899B(c)(1)(E) of the Act, whereas NQF #0419 does not.
After review of the NQF-endorsed measure, we determined that the
proposed Transfer of Health Information to the Provider-Post-Acute Care
(PAC) measure better addresses the Transfer of Health Information
measure domain, which requires that at least some of the data used to
calculate the measure be collected as standardized patient assessment
data through the post-acute care assessment instruments. Section
1899B(e)(2)(A) of the Act requires that any measure specified by the
Secretary be endorsed by the entity with a contract under section
1890(a) of the Act, which is currently the National Quality Form (NQF).
However, when a feasible and practical measure has not been NQF
endorsed for a specified area or medical topic determined appropriate
by the Secretary, section 1899B(e)(2)(B) of the Act allows the
Secretary to specify a measure that is not NQF endorsed as long as due
consideration is given to the measures that have been endorsed or
adopted by a consensus organization identified by the Secretary. For
the reasons discussed above, we believe that there is currently no
feasible NQF-endorsed measure that we could adopt under section
1899B(c)(1)(E) of the Act. However, we note that we intend to submit
the proposed measure to the NQF for consideration of endorsement when
feasible.
(5) Quality Measure Calculation
The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) quality measure is calculated as the proportion of
resident stays with a discharge assessment indicating that a current
reconciled medication list was provided to the subsequent provider at
the time of discharge. The proposed measure denominator is the total
number of SNF resident stays, ending in discharge to a ``subsequent
provider,'' which is defined as a short-term general acute-care
hospital, a skilled nursing facility (SNF), intermediate care
(intellectual and developmental disabilities providers), home under
care of an organized home health service organization or hospice,
hospice in an institutional facility, an inpatient rehabilitation
facility (IRF), an LTCH, a Medicaid nursing facility, an inpatient
psychiatric facility, or a critical access hospital (CAH). These health
care providers were selected for inclusion in the denominator because
they are identified as subsequent providers on the discharge
destination item that is currently included on the resident assessment
instrument minimum data set (MDS), the current version being MDS 3.0.
The proposed measure numerator is the number of SNF resident stays with
an MDS discharge assessment indicating a current reconciled medication
list was provided to the subsequent provider at the time of discharge.
For additional technical information about this proposed
[[Page 17641]]
measure, we refer readers to the document titled, ``Proposed
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. The data source for the proposed quality measure is the
MDS assessment instrument for SNF residents.
For more information about the data submission requirements we are
proposing for this measure, we refer readers to section VI.A.8.c. of
this proposed rule.
b. Proposed Transfer of Health Information to the Patient-Post-Acute
Care (PAC) Measure
Beginning with the FY 2022 SNF QRP, we are proposing to adopt the
Transfer of Health Information to the Patient-Post-Acute Care (PAC)
measure, a measure that satisfies the IMPACT Act domain of Transfer of
Health Information, with data collection for discharges beginning
October 1, 2020. This process-based measure assesses whether or not a
current reconciled medication list was provided to the patient, family,
or caregiver when the patient was discharged from a PAC setting to a
private home/apartment, a board and care home, assisted living, a group
home, transitional living or home under care of an organized home
health service organization, or a hospice.
(1) Background
In 2013, 22.3 percent of all acute hospital discharges were
discharged to PAC settings, including 11 percent who were discharged to
home under the care of a home health agency.\54\ Of the Medicare FFS
beneficiaries with a SNF stay in fiscal year 2017, an estimated 11
percent were discharged home with home health services, 41 percent were
discharged home with self-care, and 0.2 percent were discharged with
home hospice services.\55\
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\54\ Tian, W. ``An all-payer view of hospital discharge to
postacute care,'' May 2016. Available at https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
\55\ RTI International analysis of Medicare claims data for
index stays in SNF 2017. (RTI program reference: IB55).
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The communication of health information, such as a reconciled
medication list, is critical to ensuring safe and effective patient
transitions from health care settings to home and/or other community
settings. Incomplete or missing health information, such as medication
information, increases the likelihood of a patient safety risk, often
life-threatening.56 57 58
59 60 Individuals who use PAC care services are
particularly vulnerable to adverse health outcomes due to their higher
likelihood of having multiple comorbid chronic conditions,
polypharmacy, and complicated transitions between care
settings.61 62 Upon discharge to home,
individuals in PAC settings may be faced with numerous medication
changes, new medication regimes, and follow-up details.63
64 65 The efficient and effective communication
and coordination of medication information may be critical to prevent
potentially deadly adverse effects. When care coordination activities
enhance care transitions, these activities can reduce duplication of
care services and costs of care, resolve conflicting care plans, and
prevent medical errors.66 67
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\56\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
\57\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
\58\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
\59\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
\60\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
\61\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
\62\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation
during the transition to and from long-term care settings: a
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
\63\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
\64\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
\65\ Sheehan, O.C., Kharrazi, H., Carl, K.J., Leff, B., Wolff,
J.L., Roth, D.L., Gabbard, J., & Boyd, C.M., ``Helping older adults
improve their medication experience (HOME) by addressing medication
regimen complexity in home healthcare,'' Home Healthcare Now. 2018,
Vol. 36(1) pp. 10-19.
\66\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
\67\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C.,
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner,
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and
preventable adverse events among hospitalized children following
implementation of a resident handoff bundle,'' JAMA, 2013, Vol.
310(21), pp. 2262-2270.
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Finally, the transfer of a patient's discharge medication
information to the patient, family, or caregiver is common practice and
supported by discharge planning requirements for participation in
Medicare and Medicaid programs.68 69 Most PAC EHR
systems generate a discharge medication list to promote patient
participation in medication management, which has been shown to be
potentially useful for improving patient outcomes and transitional
care.\70\
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\68\ CMS, ``Revision to state operations manual (SOM), Hospital
Appendix A--Interpretive Guidelines for 42 CFR 482.43, Discharge
Planning'' May 17, 2013. Available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-32.pdf.
\69\ The State Operations Manual Guidance to Surveyors for Long
Term Care Facilities (Guidance Sec. 483.21(c)(1) Rev. 11-22-17) for
discharge planning process. Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
\70\ Toles, M., Colon-Emeric, C., Naylor, M.D., Asafu-Adjei, J.,
Hanson, L.C., ``Connect-home: transitional care of skilled nursing
facility patients and their caregivers,'' Am Geriatr Soc., 2017,
Vol. 65(10), pp. 2322-2328.
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(2) Stakeholder and Technical Expert Panel (TEP) Input
The proposed measure was developed after consideration of feedback
we received from stakeholders and four TEPs convened by our
contractors. Further, the proposed measure was developed after
evaluation of data collected during two pilot tests we conducted in
accordance with the CMS MMS Blueprint.
Our measure development contractors constituted a TEP which met on
September 27, 2016,\71\ January 27, 2017,
[[Page 17642]]
and August 3, 2017 \72\ to provide input on a prior version of this
measure. Based on this input, we updated the measure concept in late
2017 to include the transfer of a specific component of health
information--medication information. Our measure development
contractors reconvened this TEP on April 20, 2018 to seek expert input
on the measure. Overall, the TEP members supported the proposed
measure, affirming that the measure provides an opportunity to improve
the transfer of medication information. Most of the TEP members
believed that the measure could improve the transfer of medication
information to patients, families, and caregivers. Several TEP members
emphasized the importance of transferring information to patients and
their caregivers in a clear manner using plain language. A summary of
the April 20, 2018 TEP proceedings titled ``Transfer of Health
Information TEP Meeting 4--June 2018'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
\71\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
\72\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
---------------------------------------------------------------------------
Our measure development contractors solicited stakeholder feedback
on the proposed measure by requesting comment on the CMS Measures
Management System Blueprint website, and accepted comments that were
submitted from March 19, 2018 to May 3, 2018. Several commenters noted
the importance of ensuring that the instruction provided to patients
and caregivers is clear and understandable to promote transparent
access to medical record information and meet the goals of the IMPACT
Act. The summary report for the March 19 to May 3, 2018 public comment
period titled ``IMPACT- Medication Profile Transferred Public Comment
Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(3) Pilot Testing
Between June and August 2018, we held a pilot test involving 24 PAC
facilities/agencies, including five IRFs, six SNFs, six LTCHs, and
seven HHAs. The 24 pilot sites submitted a total of 801 assessments.
Analysis of agreement between coders within each participating facility
(241 qualifying pairs) indicated an 87 percent agreement for this
measure. Overall, pilot testing enabled us to verify its reliability,
components of face validity, and feasibility of being implemented
across PAC settings. Further, more than half of the sites that
participated in the pilot test stated, during debriefing interviews,
that the measure could distinguish facilities or agencies with higher
quality medication information transfer from those with lower quality
medication information transfer at discharge. The pilot test summary
report titled ``Transfer of Health Information 2018 Pilot Test Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(4) Measure Applications Partnership (MAP) Review and Related Measures
We included the proposed measure in the SNF QRP section of the 2018
MUC list. The MAP conditionally supported this measure pending NQF
endorsement, noting that the measure can promote the transfer of
important medication information to the patient. The MAP recommended
that providers transmit medication information to patients that is easy
to understand because health literacy can impact a person's ability to
take medication as directed. More information about the MAP's
recommendations for this measure is available at https://www.qualityforum.org/Publications/2019/02/MAP_2019_Considerations_for_Implementing_Measures_Final_Report_-_PAC-LTC.aspx.
Section 1899B(e)(2)(A) of the Act, requires that any measure
specified by the Secretary be endorsed by the entity with a contract
under section 1890(a) of the Act, which is currently the NQF. However,
when a feasible and practical measure has not been NQF-endorsed for a
specified area or medical topic determined appropriate by the
Secretary, section 1899B(e)(2)(B) of the Act allows the Secretary to
specify a measure that is not NQF-endorsed as long as due consideration
is given to the measures that have been endorsed or adopted by a
consensus organization identified by the Secretary. Therefore, in the
absence of any NQF-endorsed measures that address the proposed Transfer
of Health Information to the Patient-Post-Acute Care (PAC), which
requires that at least some of the data used to calculate the measure
be collected as standardized patient assessment data through the post-
acute care assessment instruments, we believe that there is currently
no feasible NQF-endorsed measure that we could adopt under section
1899B(c)(1)(E) of the Act. However, we note that we intend to submit
the proposed measure to the NQF for consideration of endorsement when
feasible.
(5) Quality Measure Calculation
The calculation of the proposed Transfer of Health Information to
the Patient-Post-Acute Care (PAC) measure would be based on the
proportion of resident stays with a discharge assessment indicating
that a current reconciled medication list was provided to the resident,
family, or caregiver at the time of discharge.
The proposed measure denominator is the total number of SNF
resident stays ending in discharge to a private home/apartment, a board
and care home, assisted living, a group home, transitional living or
home under care of an organized home health service organization, or a
hospice. These locations were selected for inclusion in the denominator
because they are identified as home locations on the discharge
destination item that is currently included on the MDS. The proposed
measure numerator is the number of SNF resident stays with an MDS
discharge assessment indicating a current reconciled medication list
was provided to the resident, family, or caregiver at the time of
discharge. For technical information about this proposed measure we
refer readers to the document titled ``Proposed Specifications for SNF
QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Data for the proposed quality measure would be calculated using data
from the MDS assessment instrument for SNF residents.
For more information about the data submission requirements we are
[[Page 17643]]
proposing for this measure, we refer readers to section VI.A.8.c. of
this proposed rule.
c. Proposed Update to the Discharge to Community--Post Acute Care (PAC)
Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) Measure
We are proposing to update the specifications for the Discharge to
Community--PAC SNF QRP measure to exclude baseline nursing facility
(NF) residents from the measure. This measure reports a SNF's risk-
standardized rate of Medicare FFS residents who are discharged to the
community following a SNF stay, do not have an unplanned readmission to
an acute care hospital or LTCH in the 31 days following discharge to
community, and who remain alive during the 31 days following discharge
to community. We adopted this measure in the FY 2017 SNF PPS final rule
(81 FR 52021 through 52029).
In the FY 2017 SNF PPS final rule (81 FR 52025), we addressed
public comments recommending exclusion of SNF residents who were
baseline NF residents, as these residents lived in a NF prior to their
SNF stay and may not be expected to return to the community following
their SNF stay. In the FY 2018 SNF PPS final rule (82 FR 36596), we
addressed public comments expressing support for a potential future
modification of the measure that would exclude baseline NF residents;
commenters stated that the exclusion would result in the measure more
accurately portraying quality of care provided by SNFs, while
controlling for factors outside of SNF control.
We assessed the impact of excluding baseline NF residents from the
measure using CY 2015 and CY 2016 data, and found that this exclusion
impacted both patient- and facility-level discharge to community rates.
We defined baseline NF residents as SNF residents who had a long-term
NF stay in the 180 days preceding their hospitalization and SNF stay,
with no intervening community discharge between the NF stay and
qualifying hospitalization for measure inclusion. Baseline NF residents
represented 10.4 percent of the measure population after all measure
exclusions were applied. Observed resident-level discharge to community
rates were significantly lower for baseline NF residents (2.37 percent)
compared with non-NF residents (53.32 percent). The national observed
resident-level discharge to community rate was 48.01 percent when
baseline NF residents were included in the measure, increasing to 53.32
percent when they were excluded from the measure. After excluding
baseline NF residents, 38.5 percent of SNFs had an increase in their
risk-standardized discharge to community rate that exceeded the
increase in the national observed resident-level discharge to community
rate.
Based on public comments received and our impact analysis, we are
proposing to exclude baseline NF residents from the Discharge to
Community--PAC SNF QRP measure beginning with the FY 2020 SNF QRP, with
baseline NF residents defined as SNF residents who had a long-term NF
stay in the 180 days preceding their hospitalization and SNF stay, with
no intervening community discharge between the NF stay and
hospitalization.
For additional technical information regarding the Discharge to
Community--PAC SNF QRP measure, including technical information about
the proposed exclusion, we refer readers to the document titled
``Proposed Specifications for SNF QRP Quality Measures and Standardized
Resident Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We are inviting public comment on this proposal.
5. SNF QRP Quality Measures, Measure Concepts, and Standardized Patient
Assessment Data Elements Under Consideration for Future Years: Request
for Information
We are seeking input on the importance, relevance, appropriateness,
and applicability of each of the measures, standardized patient
assessment data elements (SPADEs), and concepts under consideration
listed in the Table 13 for future years in the SNF QRP.
Table 13--Future Measures, Measure Concepts, and Standardized Patient
Assessment Data Elements (SPADEs) Under Consideration for the SNF QRP
------------------------------------------------------------------------
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Assessment-Based Quality Measures and Measure Concepts:
Functional maintenance outcomes.
Opioid use and frequency.
Exchange of electronic health information and interoperability.
Claims-Based:
Healthcare-Associated Infections in Skilled Nursing Facility (SNF)--
claims-based.
Standardized Patient Assessment Data Elements (SPADEs):
Cognitive complexity, such as executive function and memory.
Dementia.
Bladder and bowel continence including appliance use and episodes of
incontinence.
Care preferences, advance care directives, and goals of care.
Caregiver Status.
Veteran Status.
Health disparities and risk factors, including education, sex and
gender identity, and sexual orientation.
------------------------------------------------------------------------
While we will not be responding to specific comments submitted in
response to this Request for Information in the FY 2020 SNF PPS final
rule, we intend to use this input to inform our future measure and
SPADE development efforts
6. Proposed Standardized Patient Assessment Data Reporting Beginning
With the FY 2022 SNF QRP
Section 1888(e)(6)(B)(i)(III) of the Act requires that, for fiscal
years 2019 and each subsequent year, SNFs must report standardized
patient \73\ assessment data (SPADE) required under section
[[Page 17644]]
1899B(b)(1) of the Act. Section 1899B(a)(1)(C) of the Act requires, in
part, the Secretary to modify the PAC assessment instruments in order
for PAC providers, including SNFs, to submit SPADEs under the Medicare
program. Section 1899B(b)(1)(A) of the Act requires PAC providers to
submit SPADEs under applicable reporting provisions (which, for SNFs,
is the SNF QRP) with respect to the admission and discharge of an
individual (and more frequently as the Secretary deems appropriate),
and section 1899B(b)(1)(B) of the Act defines standardized patient
assessment data as data required for at least the quality measures
described in section 1899B(c)(1) of the Act and that is with respect to
the following categories: (1) Functional status, such as mobility and
self-care at admission to a PAC provider and before discharge from a
PAC provider; (2) cognitive function, such as ability to express ideas
and to understand, and mental status, such as depression and dementia;
(3) special services, treatments, and interventions, such as need for
ventilator use, dialysis, chemotherapy, central line placement, and
total parenteral nutrition; (4) medical conditions and comorbidities,
such as diabetes, congestive heart failure, and pressure ulcers; (5)
impairments, such as incontinence and an impaired ability to hear, see,
or swallow, and (6) other categories deemed necessary and appropriate
by the Secretary.
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\73\ In the FY 2018 SNF PPS final rule, we used the term
``standardized resident assessment data'' to refer to standardized
assessment data elements collected from SNF residents. However, in
this proposed rule and going forward, we will use the term
``standardized patient assessment data'' to refer to the collect of
SPADEs from SNF residents.
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In the FY 2018 SNF PPS proposed rule (82 FR 21059 through 21076),
we proposed to adopt SPADEs that would satisfy the first five
categories. In the FY 2018 SNF PPS final rule, commenters expressed
support for our adoption of SPADEs in general, including support for
our broader standardization goal and support for the clinical
usefulness of specific proposed SPADEs. However, we did not finalize
the majority of our SPADE proposals in recognition of the concern
raised by many commenters that we were moving too fast to adopt the
SPADEs and modify our assessment instruments in light of all of the
other requirements we were also adopting under the IMPACT Act at that
time (82 FR 36598 through 36600). In addition, we noted our intention
to conduct extensive testing to ensure that the standardized patient
assessment data elements we select are reliable, valid, and appropriate
for their intended use (82 FR 36599).
We did, however, finalize the adoption of SPADEs for two of the
categories described in section 1899B(b)(1)(B) of the Act: (1)
Functional status: Data elements currently reported by SNFs to
calculate the measure Application of Percent of Long-Term Care Hospital
Patients with an Admission and Discharge Functional Assessment and a
Care Plan That Addresses Function (NQF #2631); and (2) Medical
conditions and comorbidities: The data elements used to calculate the
pressure ulcer measures, Percent of Residents or Patients with Pressure
Ulcers That Are New or Worsened (Short Stay) (NQF #0678) and the
replacement measure, Changes in Skin Integrity Post-Acute Care:
Pressure Ulcer/Injury. We stated that these data elements were
important for care planning, known to be valid and reliable, and
already being reported by SNFs for the calculation of quality measures.
Since we issued the FY 2018 SNF PPS final rule, SNFs have had an
opportunity to familiarize themselves with other new reporting
requirements that we have adopted under the IMPACT Act. We have also
conducted further testing of the SPADEs, as described more fully below,
and believe that this testing supports the use of the SPADEs in our PAC
assessment instruments. Therefore, we are now proposing to adopt many
of the same SPADEs that we previously proposed to adopt, along with
other SPADEs.
We are proposing that SNFs would be required to report these SPADEs
beginning with the FY 2022 SNF QRP. If finalized as proposed, SNFs
would be required to report these data with respect to SNF admissions
and discharges that occur between October 1, 2020 and December 31, 2020
for the FY 2022 SNF QRP. Beginning with the FY 2023 SNF QRP, we propose
that SNFs must report data with respect to admissions and discharges
that occur during the subsequent calendar year (for example, CY 2021
for the FY 2023 SNF QRP, CY 2022 for the FY 2024 SNF QRP).
We are also proposing that SNFs that submit the Hearing, Vision,
Race, and Ethnicity SPADEs with respect to admission only will be
deemed to have submitted those SPADEs with respect to both admission
and discharge, because it is unlikely that the assessment of those
SPADEs at admission will differ from the assessment of the same SPADEs
at discharge.
In selecting the proposed SPADEs below, we considered the burden of
assessment-based data collection and aimed to minimize additional
burden by evaluating whether any data that is currently collected
through one or more PAC assessment instruments could be collected as
SPADE. In selecting the proposed SPADEs below, we also took into
consideration the following factors with respect to each data element:
(1) Overall clinical relevance;
(2) Interoperable exchange to facilitate care coordination during
transitions in care;
(3) Ability to capture medical complexity and risk factors that can
inform both payment and quality; and
(4) Scientific reliability and validity, general consensus
agreement for its usability.
In identifying the SPADEs proposed below, we additionally drew on
input from several sources, including TEPs held by our data element
contractor, public input, and the results of a recent National Beta
Test of candidate data elements conducted by our data element
contractor (hereafter ``National Beta Test'').
The National Beta Test collected data from 3,121 patients and
residents across 143 LTCHs, SNFs, IRFs, and HHAs from November 2017 to
August 2018 to evaluate the feasibility, reliability, and validity of
candidate data elements across PAC settings. The National Beta Test
also gathered feedback on the candidate data elements from staff who
administered the test protocol in order to understand usability and
workflow of the candidate data elements. More information on the
methods, analysis plan, and results for the National Beta Test are
available in the document titled, ``Development and Evaluation of
Candidate Standardized Patient Assessment Data Elements: Findings from
the National Beta Test (Volume 2),'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Further, to inform the proposed SPADEs, we took into account
feedback from stakeholders, as well as from technical and clinical
experts, including feedback on whether the candidate data elements
would support the factors described above. Where relevant, we also took
into account the results of the Post-Acute Care Payment Reform
Demonstration (PAC PRD) that took place from 2006 to 2012.
7. Proposed Standardized Patient Assessment Data by Category
a. Cognitive Function and Mental Status Data
A number of underlying conditions, including dementia, stroke,
traumatic brain injury, side effects of medication, metabolic and/or
endocrine imbalances, delirium, and depression, can affect cognitive
function and mental status in
[[Page 17645]]
PAC patient and resident populations.\74\ The assessment of cognitive
function and mental status by PAC providers is important because of the
high percentage of patients and residents with these conditions,\75\
and because these assessments provide opportunity for improving quality
of care.
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\74\ National Institute on Aging. (2014). Assessing Cognitive
Impairment in Older Patients. A Quick Guide for Primary Care
Physicians. Retrieved from https://www.nia.nih.gov/alzheimers/publication/assessing-cognitive-impairment-older-patients.
\75\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute
Care Payment Reform Demonstration (Final report, Volume 4 of 4).
Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------
Symptoms of dementia may improve with pharmacotherapy, occupational
therapy, or physical activity,76 77 78 and promising
treatments for severe traumatic brain injury are currently being
tested.\79\ For older patients and residents diagnosed with depression,
treatment options to reduce symptoms and improve quality of life
include antidepressant medication and
psychotherapy,80 81 82 83 and targeted services, such as
therapeutic recreation, exercise, and restorative nursing, to increase
opportunities for psychosocial interaction.\84\
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\76\ Casey D.A., Antimisiaris D., O'Brien J. (2010). Drugs for
Alzheimer's Disease: Are They Effective? Pharmacology &
Therapeutics, 35, 208-211.
\77\ Graff M.J., Vernooij-Dassen M.J., Thijssen M., Dekker J.,
Hoefnagels W.H., Rikkert M.G.O. (2006). Community Based Occupational
Therapy for Patients with Dementia and their Care Givers: Randomised
Controlled Trial. BMJ, 333(7580): 1196.
\78\ Bherer L., Erickson K.I., Liu-Ambrose T. (2013). A Review
of the Effects of Physical Activity and Exercise on Cognitive and
Brain Functions in Older Adults. Journal of Aging Research, 657508.
\79\ Giacino J.T., Whyte J., Bagiella E., et al. (2012).
Placebo-controlled trial of amantadine for severe traumatic brain
injury. New England Journal of Medicine, 366(9), 819-826.
\80\ Alexopoulos G.S., Katz I.R., Reynolds C.F. 3rd, Carpenter
D., Docherty J.P., Ross R.W. (2001). Pharmacotherapy of depression
in older patients: a summary of the expert consensus guidelines.
Journal of Psychiatric Practice, 7(6), 361-376.
\81\ Arean P.A., Cook B.L. (2002). Psychotherapy and combined
psychotherapy/pharmacotherapy for late life depression. Biological
Psychiatry, 52(3), 293-303.
\82\ Hollon S.D., Jarrett R.B., Nierenberg A.A., Thase M.E.,
Trivedi M., Rush A.J. (2005). Psychotherapy and medication in the
treatment of adult and geriatric depression: which monotherapy or
combined treatment? Journal of Clinical Psychiatry, 66(4), 455-468.
\83\ Wagenaar D., Colenda C.C., Kreft M., Sawade J., Gardiner
J., Poverejan E. (2003). Treating depression in nursing homes:
practice guidelines in the real world. J Am Osteopath Assoc.
103(10), 465-469.
\84\ Crespy S.D., Van Haitsma K., Kleban M., Hann C.J. Reducing
Depressive Symptoms in Nursing Home Residents: Evaluation of the
Pennsylvania Depression Collaborative Quality Improvement Program. J
Healthc Qual. 2016. Vol. 38, No. 6, pp. e76-e88.
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In alignment with our Meaningful Measures Initiative, accurate
assessment of cognitive function and mental status of patients and
residents in PAC is expected to make care safer by reducing harm caused
in the delivery of care; promote effective prevention and treatment of
chronic disease; strengthen person and family engagement as partners in
their care; and promote effective communication and coordination of
care. For example, standardized assessment of cognitive function and
mental status of patients and residents in PAC will support
establishing a baseline for identifying changes in cognitive function
and mental status (for example, delirium), anticipating the patient's
or resident's ability to understand and participate in treatments
during a PAC stay, ensuring patient and resident safety (for example,
risk of falls), and identifying appropriate support needs at the time
of discharge or transfer. Standardized patient assessment data elements
will enable or support clinical decision-making and early clinical
intervention; person-centered, high quality care through facilitating
better care continuity and coordination; better data exchange and
interoperability between settings; and longitudinal outcome analysis.
Therefore, reliable standardized patient assessment data elements
assessing cognitive function and mental status are needed in order to
initiate a management program that can optimize a patient's or
resident's prognosis and reduce the possibility of adverse events.
The data elements related to cognitive function and mental status
were first proposed as standardized patient assessment data elements in
the FY 2018 SNF PPS proposed rule (82 FR 21060 through 21063). In
response to our proposals, a few commenters noted that the proposed
data elements did not capture some dimensions of cognitive function and
mental status, such as functional cognition, communication, attention,
concentration, and agitation. One commenter also suggested that other
cognitive assessments should be considered for standardization. Another
commenter stated support for the standardized assessment of cognitive
function and mental status, because it could support appropriate use of
skilled therapy for beneficiaries with degenerative conditions, such as
dementia, and appropriate use of medications for behavioral and
psychological symptoms of dementia.
We are inviting comment on our proposals to collect as standardized
patient assessment data the following data with respect to cognitive
function and mental status.
Brief Interview for Mental Status (BIMS)
We are proposing that the data elements that comprise the BIMS meet
the definition of standardized patient assessment data with respect to
cognitive function and mental status under section 1899B(b)(1)(B)(ii)
of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21060
through 21061), dementia and cognitive impairment are associated with
long-term functional dependence and, consequently, poor quality of life
and increased health care costs and mortality.\85\ This makes
assessment of mental status and early detection of cognitive decline or
impairment critical in the PAC setting. The intensity of routine
nursing care is higher for patients and residents with cognitive
impairment than those without, and dementia is a significant variable
in predicting readmission after discharge to the community from PAC
providers.\86\
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\85\ Ag[uuml]ero-Torres, H., Fratiglioni, L., Guo, Z., Viitanen,
M., von Strauss, E., & Winblad, B. (1998). ``Dementia is the major
cause of functional dependence in the elderly: 3-year follow-up data
from a population-based study.'' Am J of Public Health 88(10): 1452-
1456.
\86\ RTI International. Proposed Measure Specifications for
Measures Proposed in the FY 2017 IRF QRP NPRM. Research Triangle
Park, NC. 2016.
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The BIMS is a performance-based cognitive assessment screening tool
that assesses repetition, recall with and without prompting, and
temporal orientation. The data elements that make up the BIMS are seven
questions on the repetition of three words, temporal orientation, and
recall that result in a cognitive function score. The BIMS was
developed to be a brief, objective screening tool, with a focus on
learning and memory. As a brief screener, the BIMS was not designed to
diagnose dementia or cognitive impairment, but rather to be a
relatively quick and easy to score assessment that could identify
cognitively impaired patients as well as those who may be at risk for
cognitive decline and require further assessment. It is currently in
use in two of the PAC assessments: The MDS used by SNFs and the IRF-PAI
used by IRFs. For more information on the BIMS, we refer readers to the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/
[[Page 17646]]
IMPACT-Act-Downloads-and-Videos.html.
The data elements that comprise the BIMS were first proposed as
standardized patient assessment data elements in the FY 2018 SNF PPS
proposed rule (82 FR 21060 through 21061). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted from August 12 to September 12, 2016
expressed support for use of the BIMS, noting that it is reliable,
feasible to use across settings, and will provide useful information
about patients and residents. We also stated that the data collected
through the BIMS will provide a clearer picture of patient or resident
complexity, help with the care planning process, and be useful during
care transitions and when coordinating across providers. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule, a
few commenters supported the use of the BIMS as standardized patient
assessment data elements. Other commenters were critical of the BIMS,
noting its limitations for assessing mild cognitive impairment and
functional cognition. Another stated that the BIMS should be
administered with respect to discharge, as well as admission to capture
changes during the stay. One expressed concern that the BIMS cannot be
completed by patients and residents who are unable to communicate.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
BIMS was included in the National Beta Test of candidate data elements
conducted by our data element contractor from November 2017 to August
2018. Results of this test found the BIMS to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the BIMS in the National Beta Test can be found in the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements and the TEP supported the
assessment of patient or resident cognitive status at both admission
and discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Some commenters also expressed concern that the BIMS, if used
alone, may not be sensitive enough to capture the range of cognitive
impairments, including mild cognitive impairment (MCI). A summary of
the public input received from the November 27, 2018 stakeholder
meeting titled ``Input on Standardized Patient Assessment Data Elements
(SPADEs) Received After November 27, 2018 Stakeholder Meeting'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We understand the concerns raised by stakeholders that BIMS, if
used alone, may not be sensitive enough to capture the range of
cognitive impairments, including functional cognition and MCI, but note
that the purpose of the BIMS data elements as SPADEs is to screen for
cognitive impairment in a broad population. We also acknowledge that
further cognitive tests may be required based on a patient's condition
and will take this feedback into consideration in the development of
future standardized assessment data elements. However, taking together
the importance of assessing for cognitive status, stakeholder input,
and strong test results, we are proposing that the BIMS data elements
meet the definition of standardized patient assessment data with
respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act and to adopt the BIMS as standardized
patient assessment data for use in the SNF QRP.
Confusion Assessment Method (CAM)
We are proposing that the data elements that comprise the Confusion
Assessment Method (CAM) meet the definition of standardized patient
assessment data with respect to cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21061),
the CAM was developed to identify the signs and symptoms of delirium.
It results in a score that suggests whether a patient or resident
should be assigned a diagnosis of delirium. Because patients and
residents with multiple comorbidities receive services from PAC
providers, it is important to assess delirium, which is associated with
a high mortality rate and prolonged duration of stay in hospitalized
older adults.\87\ Assessing these signs and symptoms of delirium is
clinically relevant for care planning by PAC providers.
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\87\ Fick, D.M., Steis, M.R., Waller, J.L., & Inouye, S.K.
(2013). ``Delirium superimposed on dementia is associated with
prolonged length of stay and poor outcomes in hospitalized older
adults.'' J of Hospital Med 8(9): 500-505.
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The CAM is a patient assessment that screens for overall cognitive
impairment, as well as distinguishes delirium or reversible confusion
from other types of cognitive impairment. The CAM is currently in use
in two of the PAC assessments: A four-item version of the CAM is used
in the MDS in SNFs and a six-item version of the CAM is used in the
LTCH CARE Data Set (LCDS) in LTCHs. We are proposing the four-item
version of the CAM that assesses acute change in mental status,
inattention, disorganized thinking, and altered level of consciousness.
For more information on the CAM, we refer readers to the document
titled ``Proposed Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The data elements that comprise the CAM were first proposed as
standardized patient assessment data
[[Page 17647]]
elements in the FY 2018 SNF PPS proposed rule (82 FR 21061). In that
proposed rule, we stated that the proposal was informed by input we
received on the CAM through a call for input published on the CMS
Measures Management System Blueprint website. Input submitted from
August 12 to September 12, 2016 expressed support for use of the CAM,
noting that it would provide important information for care planning
and care coordination and, therefore, contribute to quality
improvement. We also stated that those commenters had noted the CAM is
particularly helpful in distinguishing delirium and reversible
confusion from other types of cognitive impairment. A summary report
for the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment Summary Report'' is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule, a
few commenters supported the use of the CAM as standardized patient
assessment data elements, with one noting that it distinguishes
delirium or reversible confusion from other types of cognitive
impairments to share across settings for care coordination.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
CAM was included in the National Beta Test of candidate data elements
conducted by our data element contractor from November 2017 to August
2018. Results of this test found the CAM to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the CAM in the National Beta Test can be found in the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although they did not
specifically discuss the CAM data elements, the TEP supported the
assessment of patient or resident cognitive status with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for delirium,
stakeholder input, and strong test results, we are proposing that the
CAM data elements meet the definition of standardized patient
assessment data with respect to cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the Act and to adopt the CAM as
standardized patient assessment data elements for use in the SNF QRP.
b. Patient Health Questionnaire--2 to 9 (PHQ-2 to 9)
We are proposing that the Patient Health Questionnaire--2 to 9
(PHQ-2 to 9) data elements meet the definition of standardized patient
assessment data with respect to cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the Act. The proposed data elements
are based on the PHQ-2 mood interview, which focuses on only the two
cardinal symptoms of depression, and the longer PHQ-9 mood interview,
which assesses presence and frequency of nine signs and symptoms of
depression. The name of the data element, the PHQ-2 to 9, refers to an
embedded a skip pattern that transitions residents with a threshold
level of symptoms in the PHQ-2 to the longer assessment of the PHQ-9.
The skip pattern is described further below.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21062
through 21063), depression is a common and under-recognized mental
health condition. Assessments of depression help PAC providers better
understand the needs of their patients and residents by: Prompting
further evaluation after establishing a diagnosis of depression;
elucidating the patient's or resident's ability to participate in
therapies for conditions other than depression during their stay; and
identifying appropriate ongoing treatment and support needs at the time
of discharge.
The proposed PHQ-2 to 9 is based on the PHQ-9 mood interview. The
PHQ-2 consists of questions about only the first two symptoms addressed
in the PHQ-9: Depressed mood and anhedonia (inability to feel
pleasure), which are the cardinal symptoms of depression. The PHQ-2 has
performed well as both a screening tool for identifying depression, to
assess depression severity, and to monitor patient mood over
time.88 89 If a patient demonstrates signs of depressed mood
and anhedonia under the PHQ-2, then the patient is administered the
lengthier PHQ-9. This skip pattern (also referred to as a gateway) is
designed to reduce the length of the interview assessment for residents
who fail to report the cardinal symptoms of depression. The design of
the PHQ-2 to 9 reduces the burden that would be associated with the
full PHQ-9, while ensuring that patients with indications of depressive
symptoms based on the PHQ-2 receive the longer assessment.
---------------------------------------------------------------------------
\88\ Li, C., Friedman, B., Conwell, Y., & Fiscella, K. (2007).
``Validity of the Patient Health Questionnaire 2 (PHQ-2) in
identifying major depression in older people.'' J of the A
Geriatrics Society, 55(4): 596-602.
\89\ L[ouml]we, B., Kroenke, K., & Gr[auml]fe, K. (2005).
``Detecting and monitoring depression with a two-item questionnaire
(PHQ-2).'' J of Psychosomatic Research, 58(2): 163-171.
---------------------------------------------------------------------------
Components of the proposed data elements are currently used in the
OASIS for HHAs (PHQ-2) and the MDS for SNFs (PHQ-9). We are proposing
altering the administration instructions for the existing data elements
to adopt the PHQ-2 to 9 gateway logic, meaning that administration of
the full PHQ-9 is contingent on resident responses to questions about
the cardinal symptoms of depression. For more information on the PHQ-2
to 9, we refer readers to the document titled ``Proposed Specifications
for SNF QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-
[[Page 17648]]
Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The PHQ-2 data elements were first proposed as SPADEs in the FY
2018 SNF PPS proposed rule (82 FR 21062 through 21063). In that
proposed rule we stated that the proposal was informed by input we
received from the TEP convened by our data element contractor on April
6 and 7, 2016. The TEP members particularly noted that the brevity of
the PHQ-2 made it feasible to administer with low burden for both
assessors and PAC patients or residents. A summary of the April 6 and
7, 2016 TEP meeting titled ``SPADE Technical Expert Panel Summary
(First Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. That proposed rule was also informed by public input
through a call for input published on the CMS Measures Management
System Blueprint website. Input was submitted from August 12 to
September 12, 2016 on three versions of the PHQ depression screener:
The PHQ-2; the PHQ-9; and the PHQ-2 to 9 with the skip pattern design.
Many commenters provided feedback on using the PHQ-2 for the assessment
of mood. Overall, commenters believed that collecting these data
elements across PAC provider types was appropriate, given the role that
depression plays in well-being. Several commenters expressed support
for an approach that would use PHQ-2 as a gateway to the longer PHQ-9
while still potentially reducing burden on most patients and residents,
as well as test administrators, and ensuring the administration of the
PHQ-9, which exhibits higher specificity,\90\ for patients and
residents who showed signs and symptoms of depression on the PHQ-2. A
summary report for the August 12 to September 12, 2016 public comment
period titled ``SPADE August 2016 Public Comment Summary Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------
\90\ Arroll B., Goodyear-Smith F., Crengle S., Gunn J., Kerse
N., Fishman T., et al. Validation of PHQ-2 and PHQ-9 to screen for
major depression in the primary care population. Annals of family
medicine. 2010;8(4):348-353. doi: 10.1370/afm.1139 pmid:20644190;
PubMed Central PMCID: PMC2906530.
---------------------------------------------------------------------------
In response to our proposal to use the PHQ-2 in the FY 2018 SNF PPS
proposed rule, a few commenters supported screening residents for
depression with the PHQ-2. One commenter opposed the replacement of the
PHQ-9 on the MDS with PHQ-2 because of the clinical significance of
depression on quality of care and resident outcomes in the SNF
population. Another expressed concern about the use of multi-step
``gateway'' questions, because use of the PHQ-2 and PHQ-9 may result in
data not being standardized across settings and providers gathering
data unrelated to the appropriateness of care.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
PHQ-2 to 9 was included in the National Beta Test of candidate data
elements conducted by our data element contractor from November 2017 to
August 2018. Results of this test found the PHQ-2 to 9 to be feasible
and reliable for use with PAC patients and residents. More information
about the performance of the PHQ-2 to 9 in the National Beta Test can
be found in the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the PHQ-2 to
9. The TEP was supportive of the PHQ-2 to 9 data element set as a
screener for signs and symptoms of depression. The TEP's discussion
noted that symptoms evaluated by the full PHQ-9 (for example,
concentration, sleep, appetite) had relevance to care planning and the
overall well-being of the patient or resident, but that the gateway
approach of the PHQ-2 to 9 would be appropriate as a depression
screening assessment, as it depends on the well-validated PHQ-2 and
focuses on the cardinal symptoms of depression. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for depression,
stakeholder input, and strong test results, we are proposing that the
PHQ-2 to 9 data elements meet the definition of standardized patient
assessment data with respect to cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the Act and to adopt the PHQ-2 to 9
data elements as standardized patient assessment data elements for use
in the SNF QRP.
c. Special Services, Treatments, and Interventions Data
Special services, treatments, and interventions performed in PAC
can have a major effect on an individual's health status, self-image,
and quality of life. The assessment of these special services,
treatments, and interventions in PAC is important to ensure the
continuing appropriateness of care for the patients and residents
receiving them, and to support care transitions from one PAC provider
to another, an acute care hospital, or discharge. In alignment with our
Meaningful Measures Initiative, accurate assessment of special
services, treatments, and interventions of patients and residents
served by PAC providers is expected to make care safer by reducing harm
caused in the delivery of care; promote effective prevention and
treatment of chronic disease; strengthen person and family engagement
as partners in their care; and promote effective communication and
coordination of care.
For example, standardized assessment of special services,
treatments, and
[[Page 17649]]
interventions used in PAC can promote patient and resident safety
through appropriate care planning (for example, mitigating risks such
as infection or pulmonary embolism associated with central intravenous
access), and identifying life-sustaining treatments that must be
continued, such as mechanical ventilation, dialysis, suctioning, and
chemotherapy, at the time of discharge or transfer. Standardized
assessment of these data elements will enable or support: Clinical
decision-making and early clinical intervention; person-centered, high
quality care through, for example, facilitating better care continuity
and coordination; better data exchange and interoperability between
settings; and longitudinal outcome analysis. Therefore, reliable data
elements assessing special services, treatments, and interventions are
needed to initiate a management program that can optimize a patient's
or resident's prognosis and reduce the possibility of adverse events.
A TEP convened by our data element contractor provided input on all
of the proposed data elements for special services, treatments, and
interventions. In a meeting held on January 5 and 6, 2017, this TEP
found that these data elements are appropriate for standardization
because they would provide useful clinical information to inform care
planning and care coordination. The TEP affirmed that assessment of
these services and interventions is standard clinical practice, and
that the collection of these data by means of a list and checkbox
format would conform with common workflow for PAC providers. A summary
of the January 5 and 6, 2017 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Second Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Comments on the category of special services, treatments, and
interventions were also submitted by stakeholders during the FY 2018
SNF PPS proposed rule (82 FR 21063 through 21073) public comment
period. A comment across all special services, treatments, and
interventions data elements requested that the additional reporting
burden of the special services, treatments, and interventions data
elements be addressed in payment calculations. Another comment
submitted for several special services, treatments, and interventions
data elements requested additional time be allowed before the providers
are required to submit these data. One commenter expressed concern
about increased reporting burden of the data elements proposed in FY
2018 because they would require an additional look-back time frame.
Several commenters supported the inclusion of nutritional data elements
as standardized data elements noting their importance in capturing
information on care coordination and safe care transitions. One
commenter noted the limitations of the nutritional data elements,
namely that they do not capture information on swallowing or the
clinical rationale for feeding/nutrition needs.
Information on data element performance in the National Beta Test,
which collected data between November 2017 and August 2018, is reported
within each data element proposal below. Clinical staff who
participated in the National Beta Test supported these data elements
because of their importance in conveying patient or resident
significant health care needs, complexity, and progress. However,
clinical staff also noted that, despite the simple ``check box'' format
of these data element, they sometimes needed to consult multiple
information sources to determine a patient's or resident's treatments.
We are inviting comment on our proposals to collect as standardized
patient assessment data the following data with respect to special
services, treatments, and interventions.
(1) Cancer Treatment: Chemotherapy (IV, Oral, Other)
We are proposing that the Chemotherapy (IV, Oral, Other) data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21063
through 21064), chemotherapy is a type of cancer treatment that uses
drugs to destroy cancer cells. It is sometimes used when a patient has
a malignancy (cancer), which is a serious, often life-threatening or
life-limiting condition. Both intravenous (IV) and oral chemotherapy
have serious side effects, including nausea/vomiting, extreme fatigue,
risk of infection due to a suppressed immune system, anemia, and an
increased risk of bleeding due to low platelet counts. Oral
chemotherapy can be as potent as chemotherapy given by IV, and can be
significantly more convenient and less resource-intensive to
administer. Because of the toxicity of these agents, special care must
be exercised in handling and transporting chemotherapy drugs. IV
chemotherapy is administered either peripherally, or more commonly,
given via an indwelling central line, which raises the risk of
bloodstream infections. Given the significant burden of malignancy, the
resource intensity of administering chemotherapy, and the side effects
and potential complications of these highly-toxic medications,
assessing the receipt of chemotherapy is important in the PAC setting
for care planning and determining resource use. The need for
chemotherapy predicts resource intensity, both because of the
complexity of administering these potent, toxic drug combinations under
specific protocols, and because of what the need for chemotherapy
signals about the patient's underlying medical condition. Furthermore,
the resource intensity of IV chemotherapy is higher than for oral
chemotherapy, as the protocols for administration and the care of the
central line (if present) for IV chemotherapy require significant
resources.
The Chemotherapy (IV, Oral, Other) data element consists of a
principal data element (Chemotherapy) and three response option sub-
elements: IV chemotherapy, which is generally resource-intensive; Oral
chemotherapy, which is less invasive and generally requires less
intensive administration protocols; and a third category, Other,
provided to enable the capture of other less common chemotherapeutic
approaches. This third category is potentially associated with higher
risks and is more resource intensive due to chemotherapy delivery by
other routes (for example, intraventricular or intrathecal). If the
assessor indicates that the resident is receiving chemotherapy on the
principal Chemotherapy data element, the assessor would then indicate
by which route or routes (for example, IV, Oral, Other) the
chemotherapy is administered.
A single Chemotherapy data element that does not include the
proposed three sub-elements is currently in use in the MDS in SNFs. We
are proposing to expand the existing Chemotherapy data element in the
MDS to include sub-elements for IV, Oral, and Other. For more
information on the Chemotherapy (IV, Oral, Other) data element, we
refer readers to the document titled ``Proposed Specifications for SNF
QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/Post-Acute-
[[Page 17650]]
Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-
Videos.html.
The Chemotherapy data element was first proposed as a standardized
patient assessment data element in the FY 2018 SNF PPS proposed rule
(82 FR 21063 through 21064). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted from August 12 to September 12, 2016 expressed support
for the IV Chemotherapy data element and suggested it be included as
standardized patient assessment data. We also stated that those
commenters had noted that assessing the use of chemotherapy services is
relevant to share across the care continuum to facilitate care
coordination and care transitions and noted the validity of the data
element. Commenters also noted the importance of capturing all types of
chemotherapy, regardless of route, and stated that collecting data only
on patients and residents who received chemotherapy by IV would limit
the usefulness of this standardized data element. A summary report for
the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment Summary Report'' is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of Chemotherapy (IV, Oral, Other)
as standardized patient assessment data elements.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Chemotherapy data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the
Chemotherapy data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Chemotherapy data element in the National Beta Test can be found in the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP members
did not specifically discuss the Chemotherapy data element, the TEP
members supported the assessment of the special services, treatments,
and interventions included in the National Beta Test with respect to
both admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for chemotherapy,
stakeholder input, and strong test results, we are proposing, we are
proposing that the Chemotherapy (IV, Oral, Other) data element with a
principal data element and three sub-elements meet the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Chemotherapy (IV, Oral, Other) data element as
standardized patient assessment data for use in the SNF QRP.
(2) Cancer Treatment: Radiation
We are proposing that the Radiation data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21064
through 21065), radiation is a type of cancer treatment that uses high-
energy radioactivity to stop cancer by damaging cancer cell DNA, but it
can also damage normal cells. Radiation is an important therapy for
particular types of cancer, and the resource utilization is high, with
frequent radiation sessions required, often daily for a period of
several weeks. Assessing whether a patient or resident is receiving
radiation therapy is important to determine resource utilization
because PAC patients and residents will need to be transported to and
from radiation treatments, and monitored and treated for side effects
after receiving this intervention. Therefore, assessing the receipt of
radiation therapy, which would compete with other care processes given
the time burden, would be important for care planning and care
coordination by PAC providers.
The proposed data element consists of the single Radiation data
element. The Radiation data element is currently in use in the MDS in
SNFs. For more information on the Radiation data element, we refer
readers to the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Radiation data element was first proposed as a SPADE in the FY
2018 SNF PPS proposed rule (82 FR 21064 through 21065). In that
proposed rule, we stated that the proposal was informed by input we
received through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted from August 12 to
September 12, 2016, expressed support for the Radiation data element,
noting its importance and clinical usefulness for patients and
residents in PAC settings, due to the side effects and consequences of
radiation treatment on patients and residents that need to be
considered in care planning and care transitions, the feasibility of
the item, and the potential for it to improve quality. A summary
[[Page 17651]]
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of Radiation as a standardized
patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Radiation data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Radiation
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Radiation data
element in the National Beta Test can be found in the document titled
``Proposed Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP members
did not specifically discuss the Radiation data element, the TEP
members supported the assessment of the special services, treatments,
and interventions included in the National Beta Test with respect to
both admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for radiation,
stakeholder input, and strong test results, we are proposing that the
Radiation data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Radiation data element as standardized patient assessment data for
use in the SNF QRP.
(3) Respiratory Treatment: Oxygen Therapy (Intermittent, Continuous,
High-Concentration Oxygen Delivery System)
We are proposing that the Oxygen Therapy (Intermittent, Continuous,
High-Concentration Oxygen Delivery System) data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21065),
oxygen therapy provides a patient or resident with extra oxygen when
medical conditions such as chronic obstructive pulmonary disease,
pneumonia, or severe asthma prevent the patient or resident from
getting enough oxygen from breathing. Oxygen administration is a
resource-intensive intervention, as it requires specialized equipment
such as a source of oxygen, delivery systems (for example, oxygen
concentrator, liquid oxygen containers, and high-pressure systems), the
patient interface (for example, nasal cannula or mask), and other
accessories (for example, regulators, filters, tubing). The data
element proposed here captures patient or resident use of three types
of oxygen therapy (intermittent, continuous, and high-concentration
oxygen delivery system), which reflects the intensity of care needed,
including the level of monitoring and bedside care required. Assessing
the receipt of this service is important for care planning and resource
use for PAC providers.
The proposed data element, Oxygen Therapy, consists of the
principal Oxygen Therapy data element and three response option sub-
elements: Continuous (whether the oxygen was delivered continuously,
typically defined as >=14 hours per day); Intermittent; or High-
concentration oxygen delivery system. Based on public comments and
input from expert advisors about the importance and clinical usefulness
of documenting the extent of oxygen use, we added a third sub-element,
high-concentration oxygen delivery system, to the sub-elements, which
previously included only intermittent and continuous. If the assessor
indicates that the resident is receiving oxygen therapy on the
principal oxygen therapy data element, the assessor then would indicate
the type of oxygen the patient receives (for example, Continuous,
Intermittent, High-concentration oxygen delivery system).
These three proposed sub-elements were developed based on similar
data elements that assess oxygen therapy, currently in use in the MDS
in SNFs (``Oxygen Therapy''), previously used in the OASIS (``Oxygen
(intermittent or continuous)''), and a data element tested in the PAC
PRD that focused on intensive oxygen therapy (``High O2 Concentration
Delivery System with FiO2 >40 percent''). For more information on the
proposed Oxygen Therapy (Continuous, Intermittent, High-concentration
oxygen delivery system) data element, we refer readers to the document
titled ``Proposed Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Oxygen Therapy (Continuous, Intermittent) data element was
first proposed as standardized patient assessment data in the FY 2018
SNF PPS proposed rule (82 FR 21065). In that proposed rule, we stated
that the proposal was informed by input we received on the single data
element, Oxygen (inclusive of intermittent and continuous oxygen use),
through a call for input published on the CMS Measures Management
System Blueprint website. Input submitted from August 12 to September
12, 2016 expressed the importance of the Oxygen data element, noting
feasibility of this item in PAC, and the relevance of it to
[[Page 17652]]
facilitating care coordination and supporting care transitions, but
suggesting that the extent of oxygen use be documented. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule, a
few commenters supported the adoption of Oxygen Therapy (Continuous,
Intermittent) as a standardized patient assessment data element.
Another commenter recommended that an option for high-concentration
oxygen be added. In response to public comments, we added a third sub-
element for ``High-Concentration Oxygen Delivery System'' to the Oxygen
Therapy data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Oxygen Therapy data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Oxygen
Therapy data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Oxygen Therapy data element in the National Beta Test can be found in
the document titled ``Proposed Specifications for SNF QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Oxygen Therapy data element, the TEP supported
the assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing oxygen therapy,
stakeholder input, and strong test results, we are proposing that the
Oxygen Therapy (Continuous, Intermittent, High-concentration Oxygen
Delivery System) data element with a principal data element and three
sub-elements meets the definition of standardized patient assessment
data with respect to special services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Oxygen
Therapy (Continuous, Intermittent, High-concentration Oxygen Delivery
System) data element as standardized patient assessment data for use in
the SNF QRP.
(4) Respiratory Treatment: Suctioning (Scheduled, as Needed)
We are proposing that the Suctioning (Scheduled, As needed) data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21065
through 21066), suctioning is a process used to clear secretions from
the airway when a person cannot clear those secretions on his or her
own. It is done by aspirating secretions through a catheter connected
to a suction source. Types of suctioning include oropharyngeal and
nasopharyngeal suctioning, nasotracheal suctioning, and suctioning
through an artificial airway such as a tracheostomy tube. Oropharyngeal
and nasopharyngeal suctioning are a key part of many patients' care
plans, both to prevent the accumulation of secretions than can lead to
aspiration pneumonias (a common condition in patients and residents
with inadequate gag reflexes), and to relieve obstructions from mucus
plugging during an acute or chronic respiratory infection, which often
lead to desaturations and increased respiratory effort. Suctioning can
be done on a scheduled basis if the patient is judged to clinically
benefit from regular interventions, or can be done as needed when
secretions become so prominent that gurgling or choking is noted, or a
sudden desaturation occurs from a mucus plug. As suctioning is
generally performed by a care provider rather than independently, this
intervention can be quite resource intensive if it occurs every hour,
for example, rather than once a shift. It also signifies an underlying
medical condition that prevents the patient from clearing his/her
secretions effectively (such as after a stroke, or during an acute
respiratory infection). Generally, suctioning is necessary to ensure
that the airway is clear of secretions which can inhibit successful
oxygenation of the individual. The intent of suctioning is to maintain
a patent airway, the loss of which can lead to death or complications
associated with hypoxia.
The Suctioning (Scheduled, As needed) data element consists of a
principal data element, and two sub-elements: Scheduled; and As needed.
These sub-elements capture two types of suctioning. Scheduled indicates
suctioning based on a specific frequency, such as every hour; As needed
means suctioning only when indicated. If the assessor indicates that
the resident is receiving suctioning on the principal Suctioning data
element, the assessor would then indicate the frequency (for example,
Scheduled, As needed). The proposed data element is based on an item
currently in use in the MDS in SNFs which does not include our proposed
two sub-elements, as well as data elements tested in the PAC PRD that
focused on the frequency of suctioning required for patients with
tracheostomies (``Trach Tube with Suctioning: Specify most intensive
frequency of suctioning during stay [Every __hours]''). We are
proposing to expand the existing Suctioning data element on the MDS to
include sub-elements for Scheduled and As Needed. For more information
on the Suctioning data element, we refer readers to the document titled
``Proposed Specifications for SNF QRP Quality Measures and Standardized
Patient
[[Page 17653]]
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Suctioning data element was first proposed as standardized
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR
21065 through 21066). In that proposed rule, we stated that the
proposal was informed by input we received on the Suctioning data
element currently included in the MDS in SNFs through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted from August 12 to September 12, 2016 expressed support
for this data element. The input noted the feasibility of this item in
PAC, and the relevance of this data element to facilitating care
coordination and supporting care transitions. We also stated that those
commenters had suggested that we examine the frequency of suctioning to
better understand the use of staff time, the impact on a patient or
resident's capacity to speak and swallow, and intensity of care
required. Based on these comments, we decided to add two sub-elements
(Scheduled and As needed) to the suctioning element. The proposed
Suctioning data element includes both the principal Suctioning data
element that is included on the MDS in SNFs and two sub-elements,
Scheduled and As needed. A summary report for the August 12 to
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of Suctioning (Scheduled, As
needed) as a standardized patient assessment data element. One
commenter objected to ``scheduled'' suctioning as a response option due
to a clinical practice guideline recommendation that suctioning should
only be performed when clinically indicated and not on a scheduled
basis.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Suctioning data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Suctioning
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Suctioning
data element in the National Beta Test can be found in the document
titled ``Proposed Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Suctioning data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicited additional comments. General input on the
testing and item development process and concerns about burden were
received from stakeholders during this meeting and via email through
February 1, 2019. A summary of the public input received from the
November 27, 2018 stakeholder meeting titled ``Input on Standardized
Patient Assessment Data Elements (SPADEs) Received After November 27,
2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for suctioning,
stakeholder input, and strong test results, we are proposing that the
Suctioning (Scheduled, As needed) data element with a principal data
element and two sub-elements meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Suctioning (Scheduled, As needed) data element as
standardized patient assessment data for use in the SNF QRP.
(5) Respiratory Treatment: Tracheostomy Care
We are proposing that the Tracheostomy Care data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21066
through 21067), a tracheostomy provides an air passage to help a
patient or resident breathe when the usual route for breathing is
obstructed or impaired. Generally, in all of these cases, suctioning is
necessary to ensure that the tracheostomy is clear of secretions, which
can inhibit successful oxygenation of the individual. Often,
individuals with tracheostomies are also receiving supplemental
oxygenation. The presence of a tracheostomy, albeit permanent or
temporary, warrants careful monitoring and immediate intervention if
the tracheostomy becomes occluded or if the device used becomes
dislodged. While in rare cases the presence of a tracheostomy is not
associated with increased care demands (and in some of those instances,
the care of the ostomy is performed by the patient) in general the
presence of such as device is associated with increased patient risk,
and clinical care services will necessarily include close monitoring to
ensure that no life-threatening events occur as a result of the
tracheostomy. In addition, tracheostomy care, which primarily consists
of cleansing, dressing changes, and replacement of the tracheostomy
cannula (tube), is a critical part of the care plan. Regular cleansing
is important to prevent infection such as pneumonia, and to prevent any
occlusions with which there are risks for inadequate oxygenation.
The proposed data element consists of the single Tracheostomy Care
data element. The proposed data element is currently in use in the MDS
in SNFs (``Tracheostomy care''). For more information on the
Tracheostomy Care data element, we refer readers to the document titled
``Proposed Specifications for SNF QRP Quality
[[Page 17654]]
Measures and Standardized Patient Assessment Data Elements,'' available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Tracheostomy Care data element was first proposed as
standardized patient assessment data in the FY 2018 SNF PPS proposed
rule (82 FR 21066 through 21067). In that proposed rule, we stated that
the proposal was informed by input we received on the Tracheostomy Care
data element through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted from August 12 to
September 12, 2016, supported this data element, noting the feasibility
of this item in PAC, and the relevance of this data element to
facilitating care coordination and supporting care transitions. A
summary report for the August 12 to September 12, 2016 public comment
period titled ``SPADE August 2016 Public Comment Summary Report'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
we received a few comments in support of the adoption of Tracheostomy
Care as a standardized patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Tracheostomy Care data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the
Tracheostomy Care data element to be feasible and reliable for use with
PAC patients and residents. More information about the performance of
the Tracheostomy Care data element in the National Beta Test can be
found in the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Tracheostomy Care data element, the TEP
supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for tracheostomy care,
stakeholder input, and strong test results, we are proposing that the
Tracheostomy Care data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Tracheostomy Care data element as standardized patient
assessment data for use in the SNF QRP.
(6) Respiratory Treatment: Non-Invasive Mechanical Ventilator (BiPAP,
CPAP)
We are proposing that the Non-invasive Mechanical Ventilator
(Bilevel Positive Airway Pressure [BiPAP], Continuous Positive Airway
Pressure [CPAP]) data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21067),
BiPAP and CPAP are respiratory support devices that prevent the airways
from closing by delivering slightly pressurized air via electronic
cycling throughout the breathing cycle (BiPAP) or through a mask
continuously (CPAP). Assessment of non-invasive mechanical ventilation
is important in care planning, as both CPAP and BiPAP are resource-
intensive (although less so than invasive mechanical ventilation) and
signify underlying medical conditions about the patient or resident who
requires the use of this intervention. Particularly when used in
settings of acute illness or progressive respiratory decline,
additional staff (for example, respiratory therapists) are required to
monitor and adjust the CPAP and BiPAP settings and the patient or
resident may require more nursing resources.
The proposed data element, Non-invasive Mechanical Ventilator
(BIPAP, CPAP), consists of the principal Non-invasive Mechanical
Ventilator data element and two response option sub-elements: BiPAP and
CPAP. If the assessor indicates that the resident is receiving non-
invasive mechanical ventilation on the principal Non-invasive
Mechanical Ventilator data element, the assessor would then indicate
which type (for example, BIPAP, CPAP). Data elements that assess non-
invasive mechanical ventilation are currently included on LCDS for the
LTCH setting (``Non-invasive Ventilator (BIPAP, CPAP)''), and the MDS
for the SNF setting (``Non-invasive Mechanical Ventilator (BiPAP/
CPAP)''). We are proposing to expand the existing BiPAP/CPAP data
element on the MDS, retaining and relabeling the BiPAP/CPAP data
element to be Non-invasive Mechanical Ventilator (BiPAP, CPAP), and
adding two sub-elements for BiPAP and CPAP. For more information on the
Non-invasive Mechanical Ventilator (BIPAP, CPAP) data element, we refer
readers to the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Non-invasive Mechanical Ventilator data element was first
proposed as standardized patient assessment data elements in the FY
2018 SNF PPS proposed rule (82 FR 21067). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input
[[Page 17655]]
published on the CMS Measures Management System Blueprint website.
Input submitted from August 12 to September 12, 2016 on a single data
element, BiPAP/CPAP, that captures equivalent clinical information but
uses a different label than the data element currently used in the MDS
in SNFs and LCDS in LTCHs, expressed support for this data element,
noting the feasibility of these items in PAC, and the relevance of this
data element for facilitating care coordination and supporting care
transitions. In addition, we also stated that some commenters supported
separating out BiPAP and CPAP as distinct sub-elements, as they are
therapies used for different types of patients and residents. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of Non-Invasive Mechanical
Ventilator (BiPAP, CPAP) as a standardized patient assessment data
element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Non-invasive Mechanical Ventilator data element was included in the
National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Non-invasive Mechanical Ventilator data element to be
feasible and reliable for use with PAC patients and residents. More
information about the performance of the Non-invasive Mechanical
Ventilator data element in the National Beta Test can be found in the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Non-invasive Mechanical Ventilator data
element, the TEP supported the assessment of the special services,
treatments, and interventions included in the National Beta Test with
respect to both admission and discharge. A summary of the September 17,
2018 TEP meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for non-invasive
mechanical ventilation, stakeholder input, and strong test results, we
are proposing that the Non-invasive Mechanical Ventilator (BiPAP, CPAP)
data element with a principal data element and two sub-elements meets
the definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Non-invasive Mechanical
Ventilator (BiPAP, CPAP) data element as standardized patient
assessment data for use in the SNF QRP.
(7) Respiratory Treatment: Invasive Mechanical Ventilator
We are proposing that the Invasive Mechanical Ventilator data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21067
through 21068), invasive mechanical ventilation includes ventilators
and respirators that ventilate the patient through a tube that extends
via the oral airway into the pulmonary region or through a surgical
opening directly into the trachea. Thus, assessment of invasive
mechanical ventilation is important in care planning and risk
mitigation. Ventilation in this manner is a resource-intensive therapy
associated with life-threatening conditions without which the patient
or resident would not survive. However, ventilator use has inherent
risks requiring close monitoring. Failure to adequately care for the
patient or resident who is ventilator dependent can lead to iatrogenic
events such as death, pneumonia, and sepsis. Mechanical ventilation
further signifies the complexity of the patient's underlying medical or
surgical condition. Of note, invasive mechanical ventilation is
associated with high daily and aggregate costs.\91\
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\91\ Wunsch, H., Linde-Zwirble, W. T., Angus, D. C., Hartman, M.
E., Milbrandt, E. B., & Kahn, J. M. (2010). ``The epidemiology of
mechanical ventilation use in the United States.'' Critical Care Med
38(10): 1947-1953.
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The proposed data element, Invasive Mechanical Ventilator, consists
of a single data element. Data elements that capture invasive
mechanical ventilation are currently in use in the MDS in SNFs and LCDS
in LTCHs. The MDS currently assesses invasive mechanical ventilation
with the Ventilator or Respirator data element. We are proposing to
rename this data element in the MDS to be Invasive Mechanical
Ventilator. For more information on the Invasive Mechanical Ventilator
data element, we refer readers to the document titled ``Proposed
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Invasive Mechanical Ventilator data element was first proposed
as standardized patient assessment data in the FY 2018 SNF PPS proposed
rule (82 FR 21067 through 21068). In that proposed rule, we stated that
the proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website on
data elements that assess invasive ventilator use and weaning status
that were tested in the PAC PRD (``Ventilator--Weaning'' and
``Ventilator--Non-Weaning''). Input submitted from August 12 to
September 12, 2016 expressed support for this data
[[Page 17656]]
element, highlighting the importance of this information in supporting
care coordination and care transitions. We also stated that some
commenters had expressed concern about the appropriateness for
standardization given: The prevalence of ventilator weaning across PAC
providers; the timing of administration; how weaning is defined; and
how weaning status in particular relates to quality of care. These
public comments guided our decision to propose a single data element
focused on current use of invasive mechanical ventilation only, which
does not attempt to capture weaning status. A summary report for the
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment Summary Report'' we received is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule, a
few commenters supported the adoption of Invasive Mechanical Ventilator
as a standardized patient assessment data element. One commenter stated
that a data element to indicate ``weaning'' is important because it
indicates higher resource utilization.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Invasive Mechanical Ventilator data element was included in the
National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Invasive Mechanical Ventilator data element to be
feasible and reliable for use with PAC patients and residents. More
information about the performance of the Invasive Mechanical Ventilator
data element in the National Beta Test can be found in the document
titled ``Proposed Specifications for SNF QRP Quality Measures and
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Invasive Mechanical Ventilator data element,
the TEP supported the assessment of the special services, treatments,
and interventions included in the National Beta Test with respect to
both admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for invasive mechanical
ventilation, stakeholder input, and strong test results, we are
proposing that the Invasive Mechanical Ventilator data element that
assesses the use of an invasive mechanical ventilator meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Invasive Mechanical
Ventilator data element as standardized patient assessment data for use
in the SNF QRP.
(8) Intravenous (IV) Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other)
We are proposing that the IV Medications (Antibiotics,
Anticoagulants, Vasoactive Medications, Other) data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21068
through 21069), when we proposed a similar data element related to IV
medications, IV medications are solutions of a specific medication (for
example, antibiotics, anticoagulants) administered directly into the
venous circulation via a syringe or intravenous catheter. IV
medications are administered via intravenous push, single,
intermittent, or continuous infusion through a catheter placed into the
vein. Further, IV medications are more resource intensive to administer
than oral medications, and signify a higher patient complexity (and
often higher severity of illness).
The clinical indications for each of the sub-elements of the IV
Medications data element (Antibiotics, Anticoagulants, Vasoactive
Medications, and Other) are very different. IV antibiotics are used for
severe infections when the bioavailability of the oral form of the
medication would be inadequate to kill the pathogen or an oral form of
the medication does not exist. IV anticoagulants refer to anti-clotting
medications (that is, ``blood thinners''). IV anticoagulants are
commonly used for hospitalized patients who have deep venous
thrombosis, pulmonary embolism, or myocardial infarction, as well as
those undergoing interventional cardiac procedures. Vasoactive
medications refer to the IV administration of vasoactive drugs,
including vasopressors, vasodilators, and continuous medication for
pulmonary edema, which increase or decrease blood pressure or heart
rate. The indications, risks, and benefits of each of these classes of
IV medications are distinct, making it important to assess each
separately in PAC. Knowing whether or not patients and residents are
receiving IV medication and the type of medication provided by each PAC
provider will improve quality of care.
The IV Medications (Antibiotics, Anticoagulants, Vasoactive
Medications, and Other) data element we are proposing consists of a
principal data element (IV Medications) and four response option sub-
elements: Antibiotics, Anticoagulants, Vasoactive Medications, and
Other. The Vasoactive Medications sub-element was not proposed in the
FY 2018 SNF PPS proposed rule. We added the Vasoactive Medications sub-
element to our proposal in order to harmonize the proposed IV
Medications element with the data currently collected in the LCDS.
If the assessor indicates that the resident is receiving IV
medications on the principal IV Medications data element, the assessor
would then indicate which types of medications (for
[[Page 17657]]
example, Antibiotics, Anticoagulants, Vasoactive Medications, Other).
An IV Medications data element is currently in use on the MDS in SNFs
and there is a related data element in OASIS that collects information
on Intravenous and Infusion Therapies. We are proposing to expand the
existing IV Medications data element in the MDS to include sub-elements
for Antibiotics, Anticoagulants, Vasoactive Medications, and Other. For
more information on the IV Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other) data element, we refer readers to the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
An IV Medications data element was first proposed as SPADEs in the
FY 2018 SNF PPS proposed rule (82 FR 21068 through 21069). In that
proposed rule, we stated that the proposal was informed by input we
received on Vasoactive Medications through a call for input published
on the CMS Measures Management System Blueprint website. Input
submitted from August 12 to September 12, 2016 supported this data
element with one noting the importance of this data element in
supporting care transitions. We also stated that those commenters had
criticized the need for collecting specifically Vasoactive Medications,
giving feedback that the data element was too narrowly focused. In
addition, public comment received indicated that the clinical
significance of vasoactive medications administration alone was not
high enough in PAC to merit mandated assessment, noting that related
and more useful information could be captured in an item that assessed
all IV medication use. A summary report for the August 12 to September
12, 2016 public comment period titled ``SPADE August 2016 Public
Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of Intravenous (IV) Medications
(Antibiotics, Anticoagulation, Other) as a standardized patient
assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
IV Medications data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the IV
Medications data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
IV Medications data element in the National Beta Test can be found in
the document titled ``Proposed Specifications for SNF QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the IV Medications data element, the TEP supported
the assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for IV medications,
stakeholder input, and strong test results, we are proposing that the
IV Medications (Antibiotics, Anticoagulants, Vasoactive Medications,
Other) data element with a principal data element and four sub-elements
meets the definition of standardized patient assessment data with
respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and to adopt the IV Medications
(Antibiotics, Anticoagulants, Vasoactive Medications, Other) data
element as standardized patient assessment data for use in the SNF QRP.
(9) Transfusions
We are proposing that the Transfusions data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21069),
transfusion refers to introducing blood or blood products into the
circulatory system of a person. Blood transfusions are based on
specific protocols, with multiple safety checks and monitoring required
during and after the infusion in case of adverse events. Coordination
with the provider's blood bank is necessary, as well as documentation
by clinical staff to ensure compliance with regulatory requirements. In
addition, the need for transfusions signifies underlying patient
complexity that is likely to require care coordination and patient
monitoring, and impacts planning for transitions of care, as
transfusions are not performed by all PAC providers.
The proposed data element consists of the single Transfusions data
element. A data element on transfusion is currently in use in the MDS
in SNFs (``Transfusions'') and a data element tested in the PAC PRD
(``Blood Transfusions'') was found feasible for use in each of the four
PAC settings. For more information on the Transfusions data element, we
refer readers to the document titled ``Proposed Specifications for SNF
QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
[[Page 17658]]
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of Transfusions as a standardized
patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Transfusions data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the
Transfusions data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Transfusions data element in the National Beta Test can be found in the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Transfusions data element, the TEP supported
the assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for transfusions,
stakeholder input, and strong test results, we are proposing that the
Transfusions data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Transfusions data element as standardized patient assessment data
for use in the SNF QRP.
(10) Dialysis (Hemodialysis, Peritoneal Dialysis)
We are proposing that the Dialysis (Hemodialysis, Peritoneal
dialysis) data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21070),
dialysis is a treatment primarily used to provide replacement for lost
kidney function. Both forms of dialysis (hemodialysis and peritoneal
dialysis) are resource intensive, not only during the actual dialysis
process but before, during, and following. Patients and residents who
need and undergo dialysis procedures are at high risk for physiologic
and hemodynamic instability from fluid shifts and electrolyte
disturbances, as well as infections that can lead to sepsis. Further,
patients or residents receiving hemodialysis are often transported to a
different facility, or at a minimum, to a different location in the
same facility for treatment. Close monitoring for fluid shifts, blood
pressure abnormalities, and other adverse effects is required prior to,
during, and following each dialysis session. Nursing staff typically
perform peritoneal dialysis at the bedside, and as with hemodialysis,
close monitoring is required.
The proposed data element, Dialysis (Hemodialysis, Peritoneal
dialysis) consists of the principal Dialysis data element and two
response option sub-elements: Hemodialysis and Peritoneal dialysis. If
the assessor indicates that the resident is receiving dialysis on the
principal Dialysis data element, the assessor would then indicate which
type (Hemodialysis or Peritoneal dialysis). Dialysis data elements are
currently included on the MDS in SNFs and the LCDS in LTCHs and assess
the overall use of dialysis. We are proposing to expand the existing
Dialysis data element in the MDS to include sub-elements for
Hemodialysis and Peritoneal dialysis.
As the result of public feedback described below, in this proposed
rule, we are proposing a data element that includes the principal
Dialysis data element and two sub-elements (Hemodialysis and Peritoneal
dialysis). For more information on the Dialysis data elements, we refer
readers to the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Dialysis data element was first proposed as standardized
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR
21070). In that proposed rule, we stated that the proposal was informed
by input we received on a singular Hemodialysis data element through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted from August 12 to September 12, 2016
supported the assessment of hemodialysis and recommended that the data
element be expanded to include peritoneal dialysis. We also stated that
those commenters had supported the singular Hemodialysis data element,
noting the relevance of this information for sharing across the care
continuum to facilitate care coordination and care transitions, the
potential for this data element to be used to improve quality, and the
feasibility for use in PAC. In addition, we received comment that the
item would be useful in improving patient and resident transitions of
care. We also noted that several commenters had stated that peritoneal
dialysis should be included in a standardized data element on dialysis
and recommended collecting information on peritoneal dialysis in
addition to hemodialysis. The rationale for including peritoneal
dialysis from commenters included the fact that patients and residents
receiving peritoneal dialysis will have different needs at post-acute
discharge compared to those receiving hemodialysis or not having any
dialysis. Based on these comments, the Hemodialysis data element was
expanded to include a principal Dialysis data element and two sub-
elements, Hemodialysis and Peritoneal dialysis. We are proposing the
version of the Dialysis element that
[[Page 17659]]
includes two types of dialysis. A summary report for the August 12 to
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of Dialysis (Hemodialysis,
Peritoneal dialysis) as a standardized patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Dialysis data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Dialysis
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Dialysis data
element in the National Beta Test can be found in the document titled
``Proposed Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although they did not
specifically discuss the Dialysis data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for dialysis,
stakeholder input, and strong test results, we are proposing that the
Dialysis (Hemodialysis, Peritoneal dialysis) data element with a
principal data element and two sub-elements meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Dialysis (Hemodialysis, Peritoneal dialysis) data
element as standardized patient assessment data for use in the SNF QRP.
(11) Intravenous (IV) Access (Peripheral IV, Midline, Central line)
We are proposing that the IV Access (Peripheral IV, Midline,
Central line) data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21070
through 21071), patients or residents with central lines, including
those peripherally inserted or who have subcutaneous central line
``port'' access, always require vigilant nursing care to keep patency
of the lines and ensure that such invasive lines remain free from any
potentially life-threatening events such as infection, air embolism, or
bleeding from an open lumen. Clinically complex patients and residents
are likely to be receiving medications or nutrition intravenously. The
sub-elements included in the IV Access data elements distinguish
between peripheral access and different types of central access. The
rationale for distinguishing between a peripheral IV and central IV
access is that central lines confer higher risks associated with life-
threatening events such as pulmonary embolism, infection, and bleeding.
The proposed data element, IV Access (Peripheral IV, Midline,
Central line), consists of the principal IV Access data element and
three response option sub-elements: Peripheral IV, Midline, and Central
line. The proposed IV Access data element is not currently included on
any of the PAC assessment instruments. For more information on the IV
Access (Peripheral IV, Midline, Central line) data element, we refer
readers to the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The IV Access data element was first proposed as standardized
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR
21070 through 21071). In that proposed rule, we stated that the
proposal was informed by input we received on one of the PAC PRD data
elements, Central Line Management, a type of IV access, through a call
for input published on the CMS Measures Management System Blueprint
website. Input submitted from August 12 to September 12, 2016 supported
the assessment of central line management and recommended that the data
element be broadened to also include other types of IV access. Several
commenters noted feasibility and importance of facilitating care
coordination and care transitions. However, a few commenters
recommended that the definition of this data element be broadened to
include peripherally inserted central catheters (``PICC lines'') and
midline IVs. Based on public comment feedback and in consultation with
expert input, described below, we created an overarching IV Access data
element with sub-elements for other types of IV access in addition to
central lines (that is, peripheral IV and midline). This expanded
version of IV Access is the data element being proposed. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of the IV Access (Peripheral IV,
Midline,
[[Page 17660]]
Central line, Other) as a standardized patient assessment data element,
with one commenter encouraging clear guidance in the Resident
Assessment Instrument User Manual to distinguish between coding
instructions for this data element and those for other data elements on
IV treatments.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
IV Access data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the IV Access
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the IV Access data
element in the National Beta Test can be found in the document titled
``Proposed Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the IV Access data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for IV access,
stakeholder input, and strong test results, we are proposing that the
IV access (Peripheral IV, Midline, Central line) data element with a
principal data element and three sub-elements meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the IV Access (Peripheral IV, Midline, Central line)
data element as standardized patient assessment data for use in the SNF
QRP.
(12) Nutritional Approach: Parenteral/IV Feeding
We are proposing that the Parenteral/IV Feeding data element meets
the definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21071
through 21072), parenteral nutrition/IV feeding refers to a patient or
resident being fed intravenously using an infusion pump, bypassing the
usual process of eating and digestion. The need for IV/parenteral
feeding indicates a clinical complexity that prevents the patient or
resident from meeting his or her nutritional needs enterally, and is
more resource intensive than other forms of nutrition, as it often
requires monitoring of blood chemistries and the maintenance of a
central line. Therefore, assessing a patient's or resident's need for
parenteral feeding is important for care planning and resource use. In
addition to the risks associated with central and peripheral
intravenous access, total parenteral nutrition is associated with
significant risks such as air embolism and sepsis.
The proposed data element consists of the single Parenteral/IV
Feeding data element. The proposed Parenteral/IV Feeding data element
is currently in use in the MDS in SNFs, and equivalent or related data
elements are in use in the LCDS, IRF-PAI, and OASIS. For more
information on the Parenteral/IV Feeding data element, we refer readers
to the document titled ``Proposed Specifications for SNF QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Parenteral/IV Feeding data element was first proposed as a
SPADE in the FY 2018 SNF PPS proposed rule (82 FR 21071 through 21072).
In that proposed rule, we stated that the proposal was informed by
input we received on Total Parenteral Nutrition (an item with nearly
the same meaning as the proposed data element, but with the label used
in the PAC PRD) through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted from August 12 to
September 12, 2016 supported this data element, noting its relevance to
facilitating care coordination and supporting care transitions. After
the public comment period, the Total Parenteral Nutrition data element
was renamed Parenteral/IV Feeding, to be consistent with how this data
element is referred to in the MDS in SNFs. A summary report for the
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of the Parenteral/IV Feeding as a
standardized patient assessment data element, with one requesting
``universal'' guidance for coding, which would be clearly defined and
more broadly applicable to patients and residents in all PAC settings.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Parenteral/IV Feeding data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Parenteral/IV Feeding data element to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the Parenteral/IV Feeding data element in the
National Beta Test can be found in the document titled ``Proposed
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/
Quality-
[[Page 17661]]
Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Parenteral/IV Feeding data element, the TEP
supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for parenteral/IV
feeding, stakeholder input, and strong test results, we are proposing
that the Parenteral/IV Feeding data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Parenteral/IV Feeding data element as standardized
patient assessment data for use in the SNF QRP.
(13) Nutritional Approach: Feeding Tube
We are proposing that the Feeding Tube data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21072),
the majority of patients admitted to acute care hospitals experience
deterioration of their nutritional status during their hospital stay,
making assessment of nutritional status and method of feeding if unable
to eat orally very important in PAC. A feeding tube can be inserted
through the nose or the skin on the abdomen to deliver liquid nutrition
into the stomach or small intestine. Feeding tubes are resource
intensive and, therefore, are important to assess for care planning and
resource use. Patients with severe malnutrition are at higher risk for
a variety of complications.\92\ In PAC settings, there are a variety of
reasons that patients and residents may not be able to eat orally
(including clinical or cognitive status).
---------------------------------------------------------------------------
\92\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The
link between nutritional status and clinical outcome: can
nutritional intervention modify it?'' Am J of Clinical Nutrition,
47(2): 352-356.
---------------------------------------------------------------------------
The proposed data element consists of the single Feeding Tube data
element. The Feeding Tube data element is currently included in the MDS
for SNFs, and in the OASIS for HHAs, where it is labeled Enteral
Nutrition. A related data element, collected in the IRF-PAI for IRFs
(``Tube/Parenteral Feeding''), assesses use of both feeding tubes and
parenteral nutrition. For more information on the Feeding Tube data
element, we refer readers to the document titled ``Proposed
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Feeding Tube data element was first proposed as a SPADE in the
FY 2018 SNF PPS proposed rule (82 FR 21072). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted from August 12 to September 12, 2016
on an Enteral Nutrition data element (the Enteral Nutrition data item
is the same as the data element we are proposing in this proposed rule,
but is used in the OASIS under a different name) supported the data
element, noting the importance of assessing enteral nutrition status
for facilitating care coordination and care transitions. After the
public comment period, the Enteral Nutrition data element used in
public comment was renamed Feeding Tube, indicating the presence of an
assistive device. A summary report for the August 12 to September 12,
2016 public comment period titled ``SPADE August 2016 Public Comment
Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of the Feeding Tube as a
standardized patient assessment data element. Another commenter
recommended that the term ``enteral feeding'' be used instead of
``feeding tube.''
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Feeding Tube data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Feeding
Tube data element to be feasible and reliable for use with PAC patients
and residents. More information about the performance of the Feeding
Tube data element in the National Beta Test can be found in the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Feeding Tube data element, the TEP supported
the assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
[[Page 17662]]
Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-
of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for feeding tubes,
stakeholder input, and strong test results, we are proposing that the
Feeding Tube data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Feeding Tube data element as standardized patient assessment data
for use in the SNF QRP.
(14) Nutritional Approach: Mechanically Altered Diet
We are proposing that the Mechanically Altered Diet data element
meets the definition of standardized patient assessment data with
respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21072
through 21073), the Mechanically Altered Diet data element refers to
food that has been altered to make it easier for the patient or
resident to chew and swallow, and this type of diet is used for
patients and residents who have difficulty performing these functions.
Patients with severe malnutrition are at higher risk for a variety of
complications.\93\
---------------------------------------------------------------------------
\93\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The
link between nutritional status and clinical outcome: can
nutritional intervention modify it?'' Am J of Clinical Nutrition,
47(2): 352-356.
---------------------------------------------------------------------------
In PAC settings, there are a variety of reasons that patients and
residents may have impairments related to oral feedings, including
clinical or cognitive status. The provision of a mechanically altered
diet may be resource intensive, and can signal difficulties associated
with swallowing/eating safety, including dysphagia. In other cases, it
signifies the type of altered food source, such as ground or puree that
will enable the safe and thorough ingestion of nutritional substances
and ensure safe and adequate delivery of nourishment to the patient.
Often, patients and residents on mechanically altered diets also
require additional nursing supports, such as individual feeding or
direct observation, to ensure the safe consumption of the food product.
Assessing whether a patient or resident requires a mechanically altered
diet is therefore important for care planning and resource
identification.
The proposed data element consists of the single Mechanically
Altered Diet data element. The proposed data element is currently
included on the MDS for SNFs. A related data element (``Modified food
consistency/supervision'') is currently included on the IRF-PAI for
IRFs. Another related data element is included in the OASIS for HHAs
that collects information about independent eating that requires ``a
liquid, pureed or ground meat diet.'' For more information on the
Mechanically Altered Diet data element, we refer readers to the
document titled ``Proposed Specifications for SNF QRP Quality Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Mechanically Altered Diet data element was first proposed as
standardized patient assessment data in the FY 2018 SNF PPS proposed
rule (82 FR 21072 through 21073).
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported the adoption of the Mechanically Altered Diet
as a standardized patient assessment data element, with one requesting
``universal'' guidance for coding, which would be clearly defined and
more broadly applicable to patients and residents in all PAC settings.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Mechanically Altered Diet data element was included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Mechanically Altered Diet data element to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the Mechanically Altered Diet data element in
the National Beta Test can be found in the document titled ``Proposed
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Mechanically Altered Diet data element, the
TEP supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
[[Page 17663]]
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for mechanically
altered diet, stakeholder input, and strong test results, we are
proposing that the Mechanically Altered Diet data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Mechanically Altered
Diet data element as standardized patient assessment data for use in
the SNF QRP.
(15) Nutritional Approach: Therapeutic Diet
We are proposing that the Therapeutic Diet data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21073), a
therapeutic diet refers to meals planned to increase, decrease, or
eliminate specific foods or nutrients in a patient's or resident's
diet, such as a low-salt diet, for the purpose of treating a medical
condition. The use of therapeutic diets among patients and residents in
PAC provides insight on the clinical complexity of these patients and
residents and their multiple comorbidities. Therapeutic diets are less
resource intensive from the bedside nursing perspective, but do signify
one or more underlying clinical conditions that preclude the patient
from eating a regular diet. The communication among PAC providers about
whether a patient is receiving a particular therapeutic diet is
critical to ensure safe transitions of care.
The proposed data element consists of the single Therapeutic Diet
data element. This data element is currently in use in the MDS in SNFs.
For more information on the Therapeutic Diet data element, we refer
readers to the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Therapeutic Diet data element was first proposed as
standardized patient assessment data in the FY 2018 SNF PPS proposed
rule (82 FR 21073). In response to our proposal in the FY 2018 SNF PPS
proposed rule, commenters supported the adoption of the Therapeutic
Diet as a standardized patient assessment data element. Two commenters
stated that the coding instructions should be clear and more broadly
applicable to patients and residents in all PAC settings. Another two
commenters suggested that the definition of Therapeutic Diet should be
aligned with the Academy of Nutrition and Dietetics' definition, with
one stating that ``medically altered diet'' should be added to the
nutritional data elements.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Therapeutic Diet data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the
Therapeutic Diet data element to be feasible and reliable for use with
PAC patients and residents. More information about the performance of
the Therapeutic Diet data element in the National Beta Test can be
found in the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the proposed
standardized patient assessment data elements. Although the TEP did not
specifically discuss the Therapeutic Diet data element, the TEP
supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on Standardized Patient Assessment
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for therapeutic diet,
stakeholder input, and strong test results, we are proposing that the
Therapeutic Diet data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Therapeutic data element as standardized patient assessment
data for use in the SNF QRP.
(16) High Risk Drug Classes: Use and Indication
We are proposing that the High-Risk Drug Classes: Use and
Indication data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act.
Most patients and residents receiving PAC services depend on short-
and long-term medications to manage their medical conditions. However,
as a treatment, medications are not without risk; medications are in
fact a leading cause of adverse events. A study by the
[[Page 17664]]
U.S. Department of Health and Human Services found that 31 percent of
adverse events that occurred in 2008 among hospitalized Medicare
beneficiaries were related to medication.\94\ Moreover, changes in a
patient's condition, medications, and transitions between care settings
put patients and residents at risk of medication errors and adverse
drug events (ADEs). ADEs may be caused by medication errors such as
drug omissions, errors in dosage, and errors in dosing frequency.\95\
---------------------------------------------------------------------------
\94\ U.S. Department of Health and Human Services. Office of
Inspector General. Daniel R. Levinson. Adverse Events in Hospitals:
National Incidence Among Medicare Beneficiaries. OEI-06-09-00090.
November 2010.
\95\ Boockvar K.S., Liu S., Goldstein N., Nebeker J., Siu A.,
Fried T. Prescribing discrepancies likely to cause adverse drug
events after patient transfer. Qual Saf Health Care. 2009;18(1):32-
6.
---------------------------------------------------------------------------
ADEs are known to occur across different types of healthcare
settings. For example, the incidence of ADEs in the outpatient setting
has been estimated at 1.15 ADEs per 100 person-months,\96\ while the
rate of ADEs in the long-term care setting is approximately 9.80 ADEs
per 100 resident-months.\97\ In the hospital setting, the incidence has
been estimated at 15 ADEs per 100 admissions.\98\ In addition,
approximately half of all hospital-related medication errors and 20
percent of ADEs occur during transitions within, admission to, transfer
to, or discharge from a hospital.99 100 101 ADEs are more
common among older adults, who make up most patients receiving PAC
services. The rate of emergency department visits for ADEs is three
times higher among adults 65 years of age and older compared to that
among those younger than age 65.\102\
---------------------------------------------------------------------------
\96\ Gandhi T.K., Seger A.C., Overhage J.M., et al. Outpatient
adverse drug events identified by screening electronic health
records. J Patient Saf 2010;6:91-6.doi:10.1097/PTS.0b013e3181dcae06.
\97\ Gurwitz J.H., Field T.S., Judge J., Rochon P., Harrold
L.R., Cadoret C., et al. The incidence of adverse drug events in two
large academic long-term care facilities. Am J Med. 2005;
118(3):2518. Epub 2005/03/05. https://doi.org/10.1016/j.amjmed.2004.09.018 PMID: 15745723.
\98\ Hug B.L., Witkowski D.J., Sox C.M., Keohane C.A., Seger
D.L., Yoon C., Matheny M.E., Bates D.W.. Occurrence of adverse,
often preventable, events in community hospitals involving
nephrotoxic drugs or those excreted by the kidney. Kidney Int. 2009;
76:1192-1198. [PubMed: 19759525].
\99\ Barnsteiner J.H. Medication reconciliation: transfer of
medication information across settings-keeping it free from error. J
Infus Nurs. 2005;28(2 Suppl):31-36.
\100\ Rozich J., Roger, R. Medication safety: one organization's
approach to the challenge. Journal of Clinical Outcomes Management.
2001(8):27-34.
\101\ Gleason K.M., Groszek J.M., Sullivan C., Rooney D.,
Barnard C., Noskin G.A. Reconciliation of discrepancies in
medication histories and admission orders of newly hospitalized
patients. Am J Health Syst Pharm. 2004;61(16):1689-1695.
\102\ Shehab N., Lovegrove M.C., Geller A.I., Rose K.O., Weidle
N.J., Budnitz D.S. US emergency department visits for outpatient
adverse drug events, 2013-2014. JAMA. doi: 10.1001/jama.2016.16201.
---------------------------------------------------------------------------
Understanding the types of medication a patient is taking and the
reason for its use are key facets of a patient's treatment with respect
to medication. Some classes of drugs are associated with more risk than
others.\103\ We are proposing one High-Risk Drug Class data element
with six sub-elements. The six medication classes response options are:
anticoagulants; antiplatelets; hypoglycemics (including insulin);
opioids; antipsychotics; and antibiotics. These drug classes are high-
risk due to the adverse effects that may result from use. In
particular: bleeding risk is associated with anticoagulants and
antiplatelets; 104 105 fluid retention, heart failure, and
lactic acidosis are associated with hypoglycemics; \106\ misuse is
associated with opioids; \107\ fractures and strokes are associated
with antipsychotics; 108 109 and various adverse events,
such as central nervous systems effects and gastrointestinal
intolerance, are associated with antimicrobials,\110\ the larger
category of medications that include antibiotics. Moreover, some
medications in five of the six drug classes included in this data
element are included in the 2019 Updated Beers Criteria[supreg] list as
potentially inappropriate medications for use in older adults.\111\
Finally, although a complete medication list should record several
important attributes of each medication (for example, dosage, route,
stop date), recording an indication for the drug is of crucial
importance.\112\
---------------------------------------------------------------------------
\103\ Ibid.
\104\ Shoeb M., Fang M.C. Assessing bleeding risk in patients
taking anticoagulants. J Thromb Thrombolysis. 2013;35(3):312-319.
doi: 10.1007/s11239-013-0899-7.
\105\ Melkonian M., Jarzebowski W., Pautas E. Bleeding risk of
antiplatelet drugs compared with oral anticoagulants in older
patients with atrial fibrillation: a systematic review and
meta[hyphen]analysis. J Thromb Haemost. 2017;15:1500-1510. DOI:
10.1111/jth.13697.
\106\ Hamnvik O.P., McMahon G.T. Balancing Risk and Benefit with
Oral Hypoglycemic Drugs. The Mount Sinai journal of medicine, New
York. 2009; 76:234-243.
\107\ Naples J.G., Gellad W.F., Hanlon J.T. The Role of Opioid
Analgesics in Geriatric Pain Management. Clin Geriatr Med. 2016;32
(4):725-735.
\108\ Rigler S.K., Shireman T.I., Cook-Wiens G.J., Ellerbeck
E.F., Whittle J.C., Mehr D.R., Mahnken J.D. Fracture risk in nursing
home residents initiating antipsychotic medications. J Am Geriatr
Soc. 2013; 61(5):715-722. [PubMed: 23590366].
\109\ Wang S., Linkletter C., Dore D. et al. Age,
antipsychotics, and the risk of ischemic stroke in the Veterans
Health Administration. Stroke 2012;43:28-31. doi:10.1161/
STROKEAHA.111.617191.
\110\ Faulkner C.M., Cox H.L., Williamson J.C. Unique aspects of
antimicrobial use in older adults. Clin Infect Dis. 2005;40(7):997-
1004.
\111\ American Geriatrics Society 2019 Beers Criteria Update
Expert Panel. American Geriatrics Society 2019 Updated Beers
Criteria for Potentially Inappropriate Medication Use in Older
Adults. J Am Geriatr Soc 2019; 00:1-21. DOI: 10.1111/jgs.15767.
\112\ Li Y., Salmasian H., Harpaz R., Chase H., Friedman C.
Determining the reasons for medication prescriptions in the EHR
using knowledge and natural language processing. AMIA Annu Symp
Proc. 2011;2011: 768-76.
---------------------------------------------------------------------------
The High-Risk Drug Classes: Use and Indication data element
requires an assessor to record whether or not a resident is taking any
medications within the six drug classes. The six response options for
this data element are high-risk drug classes with particular relevance
to PAC patients and residents, as identified by our data element
contractor. The six response options are Anticoagulants, Antiplatelets,
Hypoglycemics, Opioids, Antipsychotics, and Antibiotics. For each drug
class, the assessor is asked to indicate if the resident is taking any
medications within the class, and, for drug classes in which
medications were being taken, whether indications for all drugs in the
class are noted in the medical record. For example, for the response
option Anticoagulants, if the assessor indicates that the resident is
taking anticoagulant medication, the assessor would then indicate if an
indication is recorded in the medication record for the
anticoagulant(s).
The High-Risk Drug Classes: Use and Indication data element that is
being proposed as a SPADE was developed as part of a larger set of data
elements to assess medication reconciliation, the process of obtaining
a patient's multiple medication lists and reconciling any
discrepancies. Similar data elements on some high-risk medications are
already included in the MDS. We are proposing to modify and expand
existing data elements in the MDS to include additional high-risk drug
classes and indications for all drug classes. For more information on
the High-Risk Drug Classes: Use and Indication data element, we refer
readers to the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
[[Page 17665]]
We sought public input on the relevance of conducting assessments
on medication reconciliation and specifically on the proposed High-Risk
Drug Classes: Use and Indication data element. Our data element
contractor presented data elements related to medication reconciliation
to the TEP convened on April 6 and 7, 2016. The TEP supported a focus
on high-risk drugs, because of higher potential for harm to patients
and residents, and were in favor of a data element to capture whether
or not indications for medications were recorded in the medical record.
A summary of the April 6 and 7, 2016 TEP meeting titled ``SPADE
Technical Expert Panel Summary (First Convening)'' is available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. Medication reconciliation data
elements were also discussed at a second TEP meeting on January 5 and
6, 2017, convened by our data element contractor. At this meeting, the
TEP agreed about the importance of evaluating the medication
reconciliation process, but disagreed about how this could be
accomplished through standardized assessment. The TEP also disagreed
about the usability and appropriateness of using the Beers Criteria to
identify high-risk medications.\113\ A summary of the January 5 and 6,
2017 TEP meeting titled ``SPADE Technical Expert Panel Summary (Second
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\113\ American Geriatrics Society 2015 Beers Criteria Update
Expert Panel. American Geriatrics Society. Updated Beers Criteria
for Potentially Inappropriate Medication Use in Older Adults. J Am
Geriatr Soc 2015; 63:2227-2246.
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We also solicited public input on data elements related to
medication reconciliation during a public input period from April 26 to
June 26, 2017. Several commenters expressed support for the medication
reconciliation data elements that were put on display, noting the
importance of medication reconciliation in preventing medication errors
and stated that the items seemed feasible and clinically useful. A few
commenters were critical of the choice of 10 drug classes posted during
that comment period, arguing that ADEs are not limited to high-risk
drugs, and raised issues related to training assessors to correctly
complete a valid assessment of medication reconciliation. A summary
report for the April 26 to June 26, 2017 public comment period titled
``SPADE May-June 2017 Public Comment Summary Report'' is available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The High-Risk Drug Classes: Use and Indication data element was
included in the National Beta Test of candidate data elements conducted
by our data element contractor from November 2017 to August 2018.
Results of this test found the High-Risk Drug Classes: Use and
Indication data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
High-Risk Drug Classes: Use and Indication data element in the National
Beta Test can be found in the document titled ``Proposed Specifications
for SNF QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. The TEP acknowledged the
challenges of assessing medication safety, but were supportive of some
of the data elements focused on medication reconciliation that were
tested in the National Beta Test. The TEP was especially supportive of
the focus on the six high-risk drug classes and using these classes to
assess whether the indication for a drug is recorded. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts. These
activities provided updates on the field-testing work and solicited
feedback on data elements considered for standardization, including the
High-Risk Drug Classes: Use and Indication data element. One
stakeholder group was critical of the six drug classes included as
response options in the High-Risk Drug Classes: Use and Indication data
element, noting that potentially risky medications (for example, muscle
relaxants) are not included in this list; that there may be important
differences between drugs within classes (for example, more recent
versus older style antidepressants); and that drug allergy information
is not captured. Finally, on November 27, 2018, our data element
contractor hosted a public meeting of stakeholders to present the
results of the National Beta Test and solicit additional comments.
General input on the testing and item development process and concerns
about burden were received from stakeholders during this meeting and
via email through February 1, 2019. Additionally, one commenter
questioned whether the time to complete this SPADE would differ across
settings. A summary of the public input received from the November 27,
2018 stakeholder meeting titled ``Input on Standardized Patient
Assessment Data Elements (SPADEs) Received After November 27, 2018
Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing high-risk drugs and for
whether or not indications are noted for high-risk drugs, stakeholder
input, and strong test results, we are proposing that the High-Risk
Drug Classes: Use and Indication data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the High-Risk Drug Classes: Use and Indication data
element as standardized patient assessment data for use in the SNF QRP.
d. Medical Condition and Comorbidity Data
Assessing medical conditions and comorbidities is critically
important for care planning and safety for patients and residents
receiving PAC services, and the standardized assessment of selected
medical conditions and comorbidities across PAC providers is important
for managing care transitions and understanding medical complexity.
Below we discuss our proposals for data elements related to the
medical
[[Page 17666]]
condition of pain as standardized patient assessment data. Appropriate
pain management begins with a standardized assessment, and thereafter
establishing and implementing an overall plan of care that is person-
centered, multi-modal, and includes the treatment team and the patient.
Assessing and documenting the effect of pain on sleep, participation in
therapy, and other activities may provide information on undiagnosed
conditions and comorbidities and the level of care required, and do so
more objectively than subjective numerical scores. With that, we assess
that taken separately and together, these proposed data elements are
essential for care planning, consistency across transitions of care,
and identifying medical complexities including undiagnosed conditions.
We also conclude that it is the standard of care to always consider the
risks and benefits associated with a personalized care plan, including
the risks of any pharmacological therapy, especially opioids.\114\ We
also conclude that in addition to assessing and appropriately treating
pain through the optimum mix of pharmacologic, non-pharmacologic, and
alternative therapies, while being cognizant of current prescribing
guidelines, clinicians in partnership with patients are best able to
mitigate factors that contribute to the current opioid crisis.\115\
\116\ \117\
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\114\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
\115\ . Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
\116\ Fishman S.M., Carr D.B., Hogans B., et al. Scope and
Nature of Pain- and Analgesia-Related Content of the United States
Medical Licensing Examination (USMLE). Pain Med Malden Mass.
2018;19(3):449-459. doi:10.1093/pm/pnx336.
\117\ Fishman S.M., Young H.M., Lucas Arwood E., et al. Core
competencies for pain management: results of an interprofessional
consensus summit. Pain Med Malden Mass. 2013;14(7):971-981.
doi:10.1111/pme.12107.
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In alignment with our Meaningful Measures Initiative, accurate
assessment of medical conditions and comorbidities of patients and
residents in PAC is expected to make care safer by reducing harm caused
in the delivery of care; promote effective prevention and treatment of
chronic disease; strengthen person and family engagement as partners in
their care; and promote effective communication and coordination of
care. The SPADEs will enable or support: Clinical decision-making and
early clinical intervention; person-centered, high quality care
through: facilitating better care continuity and coordination; better
data exchange and interoperability between settings; and longitudinal
outcome analysis. Therefore, reliable data elements assessing medical
conditions and comorbidities are needed in order to initiate a
management program that can optimize a patient's or resident's
prognosis and reduce the possibility of adverse events.
We are inviting comment that apply specifically to the standardized
patient assessment data for the category of medical conditions and co-
morbidities, specifically on:
(1) Pain Interference (Pain Effect on Sleep, Pain Interference With
Therapy Activities, and Pain Interference With Day-to-Day Activities)
In acknowledgement of the opioid crisis, we specifically are
seeking comment on whether or not we should add these pain items in
light of those concerns. Commenters should address to what extent
collection of the data below through patient queries might encourage
providers to prescribe opioids.
We are proposing that a set of three data elements on the topic of
Pain Interference (Pain Effect on Sleep, Pain Interference with Therapy
Activities, and Pain Interference with Day-to-Day Activities) meet the
definition of standardized patient assessment data with respect to
medical condition and comorbidity data under section 1899B(b)(1)(B)(iv)
of the Act.
The practice of pain management began to undergo significant
changes in the 1990s because the inadequate, non-standardized, non-
evidence-based assessment and treatment of pain became a public health
issue.\118\ In pain management, a critical part of providing
comprehensive care is performance of a thorough initial evaluation,
including assessment of both the medical and any biopsychosocial
factors causing or contributing to the pain, with a treatment plan to
address the causes of pain and to manage pain that persists over
time.\119\ Quality pain management, based on current guidelines and
evidence-based practices, can minimize unnecessary opioid prescribing
both by offering alternatives or supplemental treatment to opioids and
by clearly stating when they may be appropriate, and how to utilize
risk-benefit analysis for opioid and non-opioid treatment
modalities.\120\ Pain is not a surprising symptom in PAC patients and
residents, where healing, recovery, and rehabilitation often require
regaining mobility and other functions after an acute event.
Standardized assessment of pain that interferes with function is an
important first step towards appropriate pain management in PAC
settings. The National Pain Strategy called for refined assessment
items on the topic of pain, and describes the need for these improved
measures to be implemented in PAC assessments.\121\ Further, the focus
on pain interference, as opposed to pain intensity or pain frequency,
was supported by the TEP convened by our data element contractor as an
appropriate and actionable metric for assessing pain. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\118\ Institute of Medicine. Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education, and
Research. Washington (DC): National Academies Press (US); 2011.
https://www.ncbi.nlm.nih.gov/books/NBK91497/.
\119\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
\120\ National Academies. Pain Management and the Opioid
Epidemic: Balancing Societal and Individual Benefits and Risks of
Prescription Opioid Use. Washington DC: National Academies of
Sciences, Engineering, and Medicine.; 2017.
\121\ National Pain Strategy: A Comprehensive Population-Health
Level Strategy for Pain. https://iprcc.nih.gov/sites/default/files/HHSNational_Pain_Strategy_508C.pdf.
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We appreciate the important concerns related to the misuse and
overuse of opioids in the treatment of pain and to that end we note
that in this proposed rule we have also proposed a SPADE that assess
for the use of, as well as importantly the indication for that use of,
high risk drugs, including opioids. Further, in the FY 2017 SNF PPS
final rule (81 FR 52039) we adopted the Drug Regimen Review Conducted
With Follow-Up for Identified Issues--Post Acute Care (PAC) SNF QRP
measure which assesses whether PAC providers were responsive to
potential or actual clinically significant medication issue(s), which
includes issues associated with use and misuse of opioids for pain
management, when such issues were identified.
[[Page 17667]]
We also note that the proposed SPADE related to pain assessment are
not associated with any particular approach to management. Since the
use of opioids is associated with serious complications, particularly
in the elderly,122 123 124 an array of successful non-
pharmacologic and non-opioid approaches to pain management may be
considered PAC providers have historically used a range of pain
management strategies, including non-steroidal anti-inflammatory drugs,
ice, transcutaneous electrical nerve stimulation (TENS) therapy,
supportive devices, acupuncture, and the like. In addition, non-
pharmacological interventions for pain management include, but are not
limited to, biofeedback, application of heat/cold, massage, physical
therapy, nerve block, stretching and strengthening exercises,
chiropractic, electrical stimulation, radiotherapy, and
ultrasound.125 126 127
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\122\ Chau, D.L., Walker, V., Pai, L., & Cho, L.M. (2008).
Opiates and elderly: use and side effects. Clinical interventions in
aging, 3(2), 273-8.
\123\ Fine, P.G. (2009). Chronic Pain Management in Older
Adults: Special Considerations. Journal of Pain and Symptom
Management, 38(2): S4-S14.
\124\ Solomon, D.H., Rassen, J.A., Glynn, R.J., Garneau, K.,
Levin, R., Lee, J., & Schneeweiss, S.. (2010). Archives Internal
Medicine, 170(22):1979-1986.
\125\ Byrd L. Managing chronic pain in older adults: a long-term
care perspective. Annals of Long-Term Care: Clinical Care and Aging.
2013;21(12):34-40.
\126\ Kligler, B., Bair, M.J., Banerjea, R. et al. (2018).
Clinical Policy Recommendations from the VHA State-of-the-Art
Conference on Non-Pharmacological Approaches to Chronic
Musculoskeletal Pain. Journal of General Internal Medicine, 33(Suppl
1): 16. https://doi.org/10.1007/s11606-018-4323-z.
\127\ Chou, R., Deyo, R., Friedly, J., et al. (2017).
Nonpharmacologic Therapies for Low Back Pain: A Systematic Review
for an American College of Physicians Clinical Practice Guideline.
Annals of Internal Medicine, 166(7):493-505.
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We believe that standardized assessment of pain interference will
support PAC clinicians in applying best-practices in pain management
for chronic and acute pain, consistent with current clinical
guidelines. For example, the standardized assessment of both opioids
and pain interference would support providers in successfully tapering
patients/residents who arrive in the PAC setting with long-term opioid
use off of opioids onto non-pharmacologic treatments and non-opioid
medications, as recommended by the Society for Post-Acute and Long-Term
Care Medicine,\128\ and consistent with HHS's 5-Point Strategy To
Combat the Opioid Crisis \129\ which includes ``Better Pain
Management.''
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\128\ Society for Post-Acute and Long-Term Care Medicine (AMDA).
(2018). Opioids in Nursing Homes: Position Statement. https://paltc.org/opioids%20in%20nursing%20homes.
\129\ https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/.
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The Pain Interference data elements consist of three data elements:
Pain Effect on Sleep, Pain Interference with Therapy Activities, and
Pain Interference with Day-to-Day Activities. Pain Effect on Sleep
assesses the frequency with which pain effects a resident's sleep. Pain
Interference with Therapy Activities assesses the frequency with which
pain interferes with a resident's ability to participate in therapies.
The Pain Interference with Day-to-Day Activities assesses the extent to
which pain interferes with a resident's ability to participate in day-
to-day activities excluding therapy.
A similar data element on the effect of pain on activities is
currently included in the OASIS. A similar data element on the effect
on sleep is currently included in the MDS instrument. We are proposing
to expand and modify the existing Pain data elements in the MDS to
include the Pain Effect on Sleep; Pain Interference with Therapy
Activities; and Pain Interference with Day to Day Activities data
elements. For more information on the Pain Interference data elements,
we refer readers to the document titled ``Proposed Specifications for
SNF QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We sought public input on the relevance of conducting assessments
on pain and specifically on the larger set of Pain Interview data
elements included in the National Beta Test. The proposed data elements
were supported by comments from the TEP meeting held by our data
element contractor on April 7 to 8, 2016. The TEP affirmed the
feasibility and clinical utility of pain as a concept in a standardized
assessment. The TEP agreed that data elements on pain interference with
ability to participate in therapies versus other activities should be
addressed. Further, during a more recent convening of the same TEP on
September 17, 2018, the TEP supported the interview-based pain data
elements included in the National Beta Test. The TEP members were
particularly supportive of the items that focused on how pain
interferes with activities (that is, Pain Interference data elements),
because understanding the extent to which pain interferes with function
would enable clinicians to determine the need for appropriate pain
treatment. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We held a public input period in 2016 to solicit feedback on the
standardization of pain and several other items that were under
development in prior efforts. From the prior public comment period, we
included several pain data elements (Pain Effect on Sleep; Pain
Interference--Therapy Activities; Pain Interference--Other Activities)
in a second call for public input, open from April 26 to June 26, 2017.
The items we sought comment on were modified from all stakeholder and
test efforts. Commenters provided general comments about pain
assessment in general in addition to feedback on the specific pain
items. A few commenters shared their support for assessing pain, the
potential for pain assessment to improve the quality of care, and for
the validity and reliability of the data elements. Commenters affirmed
that the item of pain and the effect on sleep would be suitable for PAC
settings. Commenters' main concerns included redundancy with existing
data elements, feasibility and utility for cross-setting use, and the
applicability of interview-based items to patients and residents with
cognitive or communication impairments, and deficits. A summary report
for the April 26 to June 26, 2017 public comment period titled ``SPADE
May-June 2017 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Pain Interference data elements were included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Pain Interference data elements to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the Pain Interference data elements in the National Beta
Test can be found in the document titled ``Proposed Specifications for
SNF QRP Quality Measures and Standardized Patient Assessment Data
Elements,''
[[Page 17668]]
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the
standardized patient assessment data elements. The TEP supported the
interview-based pain data elements included in the National Beta Test.
The TEP members were particularly supportive of the items that focused
on how pain interferes with activities (that is, Pain Interference data
elements), because understanding the extent to which pain interferes
with function would enable clinicians to determine the need for pain
treatment. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, one commenter expressed strong support for the Pain
data elements and was encouraged by the fact that this portion of the
assessment goes beyond merely measuring the presence of pain. A summary
of the public input received from the November 27, 2018 stakeholder
meeting titled ``Input on Standardized Patient Assessment Data Elements
(SPADEs) Received After November 27, 2018 Stakeholder Meeting'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for the effect of pain
on function, stakeholder input, and strong test results, we are
proposing that the three Pain Interference data elements (Pain Effect
on Sleep, Pain Interference with Therapy Activities, and Pain
Interference with Day-to-Day Activities) meet the definition of
standardized patient assessment data with respect to medical conditions
and comorbidities under section 1899B(b)(1)(B)(iv) of the Act and to
adopt the Pain Interference data elements (Pain Effect on Sleep, Pain
Interference with Therapy Activities, and Pain Interference with Day-
to-Day Activities) data elements as standardized patient assessment
data for use in the SNF QRP.
e. Impairment Data
Hearing and vision impairments are conditions that, if unaddressed,
affect activities of daily living, communication, physical functioning,
rehabilitation outcomes, and overall quality of life. Sensory
limitations can lead to confusion in new settings, increase isolation,
contribute to mood disorders, and impede accurate assessment of other
medical conditions. Failure to appropriately assess, accommodate, and
treat these conditions increases the likelihood that patients and
residents will require more intensive and prolonged treatment. Onset of
these conditions can be gradual, so individualized assessment with
accurate screening tools and follow-up evaluations are essential to
determining which patients and residents need hearing- or vision-
specific medical attention or assistive devices and accommodations,
including auxiliary aids and/or services, and to ensure that person-
directed care plans are developed to accommodate a patient's or
resident's needs. Accurate diagnosis and management of hearing or
vision impairment would likely improve rehabilitation outcomes and care
transitions, including transition from institutional-based care to the
community. Accurate assessment of hearing and vision impairment would
be expected to lead to appropriate treatment, accommodations, including
the provision of auxiliary aids and services during the stay, and
ensure that patients and residents continue to have their vision and
hearing needs met when they leave the facility.
In alignment with our Meaningful Measures Initiative, we expect
accurate and individualized assessment, treatment, and accommodation of
hearing and vision impairments of patients and residents in PAC to make
care safer by reducing harm caused in the delivery of care; promote
effective prevention and treatment of chronic disease; strengthen
person and family engagement as partners in their care; and promote
effective communication and coordination of care. For example,
standardized assessment of hearing and vision impairments used in PAC
will support ensuring patient safety (for example, risk of falls),
identifying accommodations needed during the stay, and appropriate
support needs at the time of discharge or transfer. Standardized
assessment of these data elements will: Enable or support clinical
decision-making and early clinical intervention; person-centered, high
quality care (for example, facilitating better care continuity and
coordination); better data exchange and interoperability between
settings; and longitudinal outcome analysis. Therefore, reliable data
elements assessing hearing and vision impairments are needed to
initiate a management program that can optimize a patient's or
resident's prognosis and reduce the possibility of adverse events.
Comments on the category of impairments were also submitted by
stakeholders during the FY 2018 SNF PPS proposed rule (82 FR 21074
through 21076) public comment period. A commenter stated hearing,
vision, and communication assessments should be administered at the
beginning of assessment process, to provide evidence about any sensory
deficits that may affect the patient's or resident's ability to
participate in the assessment and to allow the assessor to offer an
assistive device. Another commenter supported the decision to assess
hearing and vision with respect to admission only and not discharge,
and to use existing MDS items for hearing and vision, thereby not
creating additional burden.
We are inviting comment on our proposals to collect as standardized
patient assessment data the following data with respect to impairments.
(1) Hearing
We are proposing that the Hearing data element meets the definition
of standardized patient assessment data with respect to impairments
under section 1899B(b)(1)(B)(v) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21074
through 21075), accurate assessment of hearing impairment is important
in the PAC setting for care planning and resource use. Hearing
impairment has been associated with lower quality of life, including
poorer physical, mental, social functioning, and emotional
health.130 131 Treatment and
[[Page 17669]]
accommodation of hearing impairment led to improved health outcomes,
including but not limited to quality of life.\132\ For example, hearing
loss in elderly individuals has been associated with depression and
cognitive impairment,133 134 135 higher rates of incident
cognitive impairment and cognitive decline,\136\ and less time in
occupational therapy.\137\ Accurate assessment of hearing impairment is
important in the PAC setting for care planning and defining resource
use.
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\130\ Dalton D.S., Cruickshanks K.J., Klein B.E., Klein R, Wiley
T.L., Nondahl D.M. The impact of hearing loss on quality of life in
older adults. Gerontologist. 2003;43(5):661-668.
\131\ Hawkins K., Bottone F.G., Jr., Ozminkowski R.J., et al.
The prevalence of hearing impairment and its burden on the quality
of life among adults with Medicare Supplement Insurance. Qual Life
Res. 2012;21(7):1135-1147.
\132\ Horn K.L., McMahon N.B., McMahon D.C., Lewis J.S., Barker
M., Gherini S. Functional use of the Nucleus 22-channel cochlear
implant in the elderly. The Laryngoscope. 1991;101(3):284-288.
\133\ Sprinzl G.M., Riechelmann H. Current trends in treating
hearing loss in elderly people: A review of the technology and
treatment options--a mini-review. Gerontology. 2010;56(3):351-358.
\134\ Lin F.R., Thorpe R., Gordon-Salant S., Ferrucci L. Hearing
Loss Prevalence and Risk Factors Among Older Adults in the United
States. The Journals of Gerontology Series A: Biological Sciences
and Medical Sciences. 2011;66A(5):582-590.
\135\ Hawkins K., Bottone F.G., Jr., Ozminkowski R.J., et al.
The prevalence of hearing impairment and its burden on the quality
of life among adults with Medicare Supplement Insurance. Qual Life
Res. 2012;21(7):1135-1147.
\136\ Lin F.R., Metter E.J., O'Brien R.J., Resnick S.M.,
Zonderman A.B., Ferrucci L. Hearing Loss and Incident Dementia. Arch
Neurol. 2011;68(2):214-220.
\137\ Cimarolli V.R., Jung S. Intensity of Occupational Therapy
Utilization in Nursing Home Residents: The Role of Sensory
Impairments. J Am Med Dir Assoc. 2016;17(10):939-942.
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The proposed data element consists of the single Hearing data
element. This data consists of one question that assesses level of
hearing impairment. This data element is currently in use in the MDS in
SNFs. For more information on the Hearing data element, we refer
readers to the document titled ``Proposed Specifications for SNF QRP
Quality Measures and Standardized Patient Assessment Data Elements,''
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Hearing data element was first proposed as a SPADE in the FY
2018 SNF PPS proposed rule (82 FR 21074 through 21075). In that
proposed rule, we stated that the proposal was informed by input we
received on the PAC PRD form of the data element (``Ability to Hear'')
through a call for input published on the CMS Measures Management
System Blueprint website. Input submitted from August 12 to September
12, 2016 recommended that hearing, vision, and communication
assessments be administered at the beginning of patient assessment
process. A summary report for the August 12 to September 12, 2016
public comment period titled ``SPADE August 2016 Public Comment Summary
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported Hearing as a standardized patient assessment
data element to facilitate care coordination. One stated that coding
instructions about use of a hearing device by the resident should be
more clearly defined. Commenters were supportive of adopting the
Hearing data element for standardized cross-setting use, noting that it
would help address the needs of patient and residents with disabilities
and that failing to identify impairments during the initial assessment
can result in inaccurate diagnoses of impaired language or cognition
and can validate other information obtained from patient assessment.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Hearing data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Hearing
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Hearing data
element in the National Beta Test can be found in the document titled
``Proposed Specifications for SNF QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on January
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs,
including the Hearing data element. The TEP affirmed the importance of
standardized assessment of hearing impairment in PAC patients and
residents. A summary of the January 5 and 6, 2017 TEP meeting titled
``SPADE Technical Expert Panel Summary (Second Convening)'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, a commenter expressed support for the Hearing data
element and suggested administration at the beginning of the patient
assessment to maximize utility. A summary of the public input received
from the November 27, 2018 stakeholder meeting titled ``Input on
Standardized Patient Assessment Data Elements (SPADEs) Received After
November 27, 2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for hearing,
stakeholder input, and strong test results, we are proposing that the
Hearing data element meets the definition of standardized patient
assessment data with respect to impairments under section
1899B(b)(1)(B)(v) of the Act and to adopt the Hearing data element as
standardized patient assessment data for use in the SNF QRP.
(2) Vision
We are proposing that the Vision data element meets the definition
of SPADE with respect to impairments under section 1899B(b)(1)(B)(v) of
the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21075
through 21076), evaluation of an individual's ability to see is
important for assessing for risks such as falls and provides
opportunities for improvement through treatment and the provision of
accommodations, including auxiliary aids and services, which can
safeguard patients and residents and improve their overall quality of
life. Further, vision impairment is often a treatable risk factor
associated with adverse events and poor quality of life. For example,
individuals with visual impairment are more likely to experience falls
and hip fracture, have less mobility, and report depressive
[[Page 17670]]
symptoms.138 139 140 141 142 143 144 Individualized initial
screening can lead to life-improving interventions such as
accommodations, including the provision of auxiliary aids and services,
during the stay and/or treatments that can improve vision and prevent
or slow further vision loss. In addition, vision impairment is often a
treatable risk factor associated with adverse events which can be
prevented and accommodated during the stay. Accurate assessment of
vision impairment is important in the SNF setting for care planning and
defining resource use.
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\138\ Colon-Emeric CS, Biggs DP, Schenck AP, Lyles KW. Risk
factors for hip fracture in skilled nursing facilities: who should
be evaluated? Osteoporos Int. 2003;14(6):484-489.
\139\ Freeman EE, Munoz B, Rubin G, West SK. Visual field loss
increases the risk of falls in older adults: the Salisbury eye
evaluation. Invest Ophthalmol Vis Sci. 2007;48(10):4445-4450.
\140\ Keepnews D, Capitman JA, Rosati RJ. Measuring patient-
level clinical outcomes of home health care. J Nurs Scholarsh.
2004;36(1):79-85.
\141\ Nguyen HT, Black SA, Ray LA, Espino DV, Markides KS.
Predictors of decline in MMSE scores among older Mexican Americans.
J Gerontol A Biol Sci Med Sci. 2002;57(3):M181-185.
\142\ Prager AJ, Liebmann JM, Cioffi GA, Blumberg DM. Self-
reported Function, Health Resource Use, and Total Health Care Costs
Among Medicare Beneficiaries With Glaucoma. JAMA ophthalmology.
2016;134(4):357-365.
\143\ Rovner BW, Ganguli M. Depression and disability associated
with impaired vision: the MoVies Project. J Am Geriatr Soc.
1998;46(5):617-619.
\144\ Tinetti ME, Ginter SF. The nursing home life-space
diameter. A measure of extent and frequency of mobility among
nursing home residents. J Am Geriatr Soc. 1990;38(12):1311-1315.
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The proposed data element consists of the single Vision data
element (Ability To See in Adequate Light) that consists of one
question with five response categories. The Vision data element that we
are proposing for standardization was tested as part of the development
of the MDS in SNFs and is currently in use in that assessment. Similar
data elements, but with different wording and fewer response option
categories, are in use in the OASIS. For more information on the Vision
data element, we refer readers to the document titled ``Proposed
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The Vision data element was first proposed as a SPADE in the FY
2018 SNF PPS proposed rule (82 FR 21075 through 21076). In that
proposed rule, we stated that the proposal was informed by input we
received on the Ability to See in Adequate Light data element (version
tested in the PAC PRD with three response categories) through a call
for input published on the CMS Measures Management System Blueprint
website. Although the data element in public comment differed from the
proposed data element, input submitted from August 12 to September 12,
2016 supported assessing vision in PAC settings and the useful
information a vision data element would provide. We also stated that
commenters had noted that the Ability to See item would provide
important information that would facilitate care coordination and care
planning, and consequently improve the quality of care. Other
commenters suggested it would be helpful as an indicator of resource
use and noted that the item would provide useful information about the
abilities of patients and residents to care for themselves. Additional
commenters noted that the item could feasibly be implemented across PAC
providers and that its kappa scores from the PAC PRD support its
validity. Some commenters noted a preference for MDS version of the
Vision data element in SNFs over the form put forward in public
comment, citing the widespread use of this data element. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment Summary Report'' is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In response to our proposal in the FY 2018 SNF PPS proposed rule,
two commenters supported Vision as a standardized patient assessment
data element to facilitate care coordination. One stated that coding
instructions for use of a vision device by the resident should be more
clearly defined. Commenters recommended that hearing, vision, and
communication assessments be administered at the beginning of patient
assessment process. One commenter supported having a SPADE for vision
across PAC settings, but stated it captures only basic information for
risk adjustment, and more detailed information would need to be
collected to use it as an outcome measure.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the
Vision data element was included in the National Beta Test of candidate
data elements conducted by our data element contractor from November
2017 to August 2018. Results of this test found the Vision data element
to be feasible and reliable for use with PAC patients and residents.
More information about the performance of the Vision data element in
the National Beta Test can be found in the document titled ``Proposed
Specifications for SNF QRP Quality Measures and Standardized Patient
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In addition, our data element contractor convened a TEP on January
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs
including the Vision data element. The TEP affirmed the importance of
standardized assessment of vision impairment in PAC patients and
residents. A summary of the January 5 and 6, 2017 TEP meeting titled
``SPADE Technical Expert Panel Summary (Second Convening)'' is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our on-going SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, a commenter expressed support for the Vision data
element and suggested administration at the beginning of the patient
assessment to maximize utility. A summary of the public input received
from the November 27, 2018 stakeholder meeting titled ``Input on
Standardized Patient Assessment Data Elements (SPADEs) Received After
November 27, 2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
Taking together the importance of assessing for vision, stakeholder
input, and strong test results, we are proposing that the Vision data
element meets the definition of standardized patient assessment data
with respect to
[[Page 17671]]
impairments under section 1899B(b)(1)(B)(v) of the Act and to adopt the
Vision data element as standardized patient assessment data for use in
the SNF QRP.
f. Proposed New Category: Social Determinants of Health
(1) Proposed Social Determinants of Health Data Collection To Inform
Measures and Other Purposes
Subparagraph (A) of section 2(d)(2) of the IMPACT Act requires CMS
to assess appropriate adjustments to quality measures, resource
measures, and other measures, and to assess and implement appropriate
adjustments to payment under Medicare based on those measures, after
taking into account studies conducted by ASPE on social risk factors
(described below) and other information, and based on an individual's
health status and other factors. Subparagraph (C) of section 2(d)(2) of
the IMPACT Act further requires the Secretary to carry out periodic
analyses, at least every three years, based on the factors referred to
subparagraph (A) so as to monitor changes in possible relationships.
Subparagraph (B) of section 2(d)(2) of the IMPACT Act requires CMS to
collect or otherwise obtain access to data necessary to carry out the
requirement of the paragraph (both assessing adjustments described
above in such subparagraph (A) and for periodic analyses in such
subparagraph (C)). Accordingly we are proposing to use our authority
under subparagraph (B) of section 2(d)(2) of the IMPACT Act to
establish a new data source for information to meet the requirements of
subparagraphs (A) and (C) of section 2(d)(2) of the IMPACT Act. In this
rule, we are proposing to collect and access data about social
determinants of health (SDOH) to perform CMS' responsibilities under
subparagraphs (A) and (C) of section 2(d)(2) of the IMPACT Act, as
explained in more detail below. Social determinants of health, also
known as social risk factors, or health-related social needs, are the
socioeconomic, cultural and environmental circumstances in which
individuals live that impact their health. We are proposing to collect
information on seven proposed SDOH SPADE data elements relating to
race, ethnicity, preferred language, interpreter services, health
literacy, transportation, and social isolation; a detailed discussion
of each of the proposed SDOH data elements is found in section
VI.A.7.f.(2) of this proposed rule.
We are also proposing to use the resident assessment instrument
minimum data set (MDS), the current version being MDS 3.0, described as
a PAC assessment instrument under section 1899B(a)(2)(B) of the Act, to
collect these data via an existing data collection mechanism. We
believe this approach will provide CMS with access to data with respect
to the requirements of section 2(d)(2) of the IMPACT Act, while
minimizing the reporting burden on PAC health care providers by relying
on a data reporting mechanism already used and an existing system to
which PAC health care providers are already accustomed.
The IMPACT Act includes several requirements applicable to the
Secretary, in addition to those imposing new data reporting obligations
on certain PAC providers as discussed in section VI.A.7.f.(2) of this
proposed rule. Subparagraphs (A) and (B) of section 2(d)(1) of the
IMPACT Act require the Secretary, acting through the Office of the
Assistant Secretary for Planning and Evaluation (ASPE), to conduct two
studies that examine the effect of risk factors, including individuals'
socioeconomic status, on quality, resource use and other measures under
the Medicare program. The first ASPE study was completed in December
2016 and is discussed below, and the second study is to be completed in
the fall of 2019. We recognize that ASPE, in its studies, is
considering a broader range of social risk factors than the SDOH data
elements in this proposal, and address both PAC and non-PAC settings.
We acknowledge that other data elements may be useful to understand,
and that some of those elements may be of particular interest in non-
PAC settings. For example, for beneficiaries receiving care in the
community, as opposed to an in-patient facility, housing stability and
food insecurity may be more relevant. We will continue to take into
account the findings from both of ASPE's reports in future policy
making.
One of the ASPE's first actions under the IMPACT Act was to
commission the National Academies of Sciences, Engineering, and
Medicine (NASEM) to define and conceptualize socioeconomic status for
the purposes of ASPE's two studies under section 2(d)(1) of the IMPACT
Act. The NASEM convened a panel of experts in the field and conducted
an extensive literature review. Based on the information collected, the
2016 NASEM panel report titled, ``Accounting for Social Risk Factors in
Medicare Payment: Identifying Social Risk Factors,'' concluded that the
best way to assess how social processes and social relationships
influence key health-related outcomes in Medicare beneficiaries is
through a framework of social risk factors instead of socioeconomic
status. Social risk factors discussed in the NASEM report include
socioeconomic position, race, ethnicity, gender, social context, and
community context. These factors are discussed at length in chapter 2
of the NASEM report, titled ``Social Risk Factors.'' \145\ Consequently
NASEM framed the results of its report in terms of ``social risk
factors'' rather than ``socioeconomic status'' or ``sociodemographic
status.'' The full text of the ``Social Risk Factors'' NASEM report is
available for reading on the website at https://www.nap.edu/read/21858/chapter/1.
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\145\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Chapter 2. Washington, DC: The
National Academies Press.
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Each of the data elements we are proposing to collect and access
pursuant to our authority under section 2(d)(2)(B) of the IMPACT Act is
identified in the 2016 NASEM report as a social risk factor that has
been shown to impact care use, cost and outcomes for Medicare
beneficiaries. CMS uses the term social determinants of health (SDOH)
to denote social risk factors, which is consistent with the objectives
of Healthy People 2020.\146\
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\146\ Social Determinants of Health. Healthy People 2020.
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
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ASPE issued its first Report to Congress, titled ``Social Risk
Factors and Performance Under Medicare's Value-Based Purchasing
Programs,'' pursuant to section 2(d)(1)(A) of the IMPACT Act on
December 21, 2016.\147\ Using NASEM's social risk factors framework,
ASPE focused on the following social risk factors, in addition to
disability: (1) Dual enrollment in Medicare and Medicaid as a marker
for low income, (2) residence in a low-income area, (3) Black race, (4)
Hispanic ethnicity, and; (5) residence in a rural area. ASPE
acknowledged that the social risk factors examined in its report were
limited due to data availability. The report also noted that the data
necessary to meaningfully attempt to reduce disparities and identify
and reward improved outcomes for beneficiaries with social risk factors
have not been collected consistently on a national level in post-acute
care settings. Where these data have been collected, the
[[Page 17672]]
collection frequently involves lengthy questionnaires. More information
on the Report to Congress on Social Risk Factors and Performance under
Medicare's Value-Based Purchasing Programs, including the full report,
is available on the website at https://aspe.hhs.gov/social-risk-factors-and-medicares-value-based-purchasing-programs-reports.
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\147\ U.S. Department of Health and Human Services, Office of
the Assistant Secretary for Planning and Evaluation. 2016. Report to
Congress: Social Risk Factors and Performance Under Medicare's
Value-Based Payment Programs. Washington, DC.
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Section 2(d)(2) of the IMPACT Act relates to CMS activities and
imposes several responsibilities on the Secretary relating to quality,
resource use, and other measures under Medicare. As mentioned
previously, under subparagraph (A) of section 2(d)(2) of the IMPACT
Act, the Secretary is required, on an ongoing basis, taking into
account the ASPE studies and other information, and based on an
individual's health status and other factors, to assess appropriate
adjustments to quality, resource use, and other measures, and to assess
and implement appropriate adjustments to Medicare payments based on
those measures. Section 2(d)(2)(A)(i) of the IMPACT Act applies to
measures adopted under subsections (c) and (d) of section 1899B of the
Act and to other measures under Medicare. However, CMS' ability to
perform these analyses, and assess and make appropriate adjustments is
hindered by limits of existing data collections on SDOH data elements
for Medicare beneficiaries. In its first study in 2016, in discussing
the second study, ASPE noted that information relating to many of the
specific factors listed in the IMPACT Act, such as health literacy,
limited English proficiency, and Medicare beneficiary activation, are
not available in Medicare data.
Subparagraph 2(d)(2)(A) of the IMPACT Act specifically requires the
Secretary to take the studies and considerations from ASPE's reports to
Congress, as well as other information as appropriate, into account in
assessing and implementing adjustments to measures and related payments
based on measures in Medicare. The results of the ASPE's first study
demonstrated that Medicare beneficiaries with social risk factors
tended to have worse outcomes on many quality measures, and providers
who treated a disproportionate share of beneficiaries with social risk
factors tended to have worse performance on quality measures. As a
result of these findings, ASPE suggested a three-pronged strategy to
guide the development of value-based payment programs under which all
Medicare beneficiaries receive the highest quality healthcare services
possible. The three components of this strategy are to: (1) Measure and
report quality of care for beneficiaries with social risk factors; (2)
set high, fair quality standards for care provided to all
beneficiaries; and (3) reward and support better outcomes for
beneficiaries with social risk factors. In discussing how measuring and
reporting quality for beneficiaries with social risk factors can be
applied to Medicare quality payment programs, the report offered nine
considerations across the three-pronged strategy, including enhancing
data collection and developing statistical techniques to allow
measurement and reporting of performance for beneficiaries with social
risk factors on key quality and resource use measures.
Congress, in section 2(d)(2)(B) of the IMPACT Act, required the
Secretary to collect or otherwise obtain access to the data necessary
to carry out the provisions of paragraph (2) of section 2(d) of the
IMPACT Act through both new and existing data sources. Taking into
consideration NASEM's conceptual framework for social risk factors
discussed above, ASPE's study, considerations under section 2(d)(1)(A)
of the IMPACT Act, as well as the current data constraints of ASPE's
first study and its suggested considerations, we are proposing to
collect and access data about SDOH under section 2(d)(2) of the IMPACT
Act. Our collection and use of the SDOH data described in section
VI.A.7.f.(1) of this proposed rule, under section 2(d)(2) of the IMPACT
Act, would be independent of our proposal below (in section
VI.A.7.f.(2) of this proposed rule and our authority to require
submission of that data for use as SPADE under section 1899B(a)(1)(B)
of the Act.
Accessing standardized data relating to the SDOH data elements on a
national level is necessary to permit CMS to conduct periodic analyses,
to assess appropriate adjustments to quality measures, resource use
measures, and other measures, and to assess and implement appropriate
adjustments to Medicare payments based on those measures. We agree with
ASPE's observations, in the value-based purchasing context, that the
ability to measure and track quality, outcomes, and costs for
beneficiaries with social risk factors over time is critical as
policymakers and providers seek to reduce disparities and improve care
for these groups. Collecting the data as proposed will provide the
basis for our periodic analyses of the relationship between an
individual's health status and other factors and quality, resource use,
and other measures, as required by section 2(d)(2) of the IMPACT Act,
and to assess appropriate adjustments. These data will also permit us
to develop the statistical tools necessary to maximize the value of
Medicare data, reduce costs and improve the quality of care for all
beneficiaries. Collecting and accessing SDOH data in this way also
supports the three-part strategy put forth in the first ASPE report,
specifically ASPE's consideration to enhance data collection and
develop statistical techniques to allow measurement and reporting of
performance for beneficiaries with social risk factors on key quality
and resource use measures.
For the reasons discussed above, we are proposing under section
2(d)(2) of the IMPACT Act, to collect the data on the following SDOH:
(1) Race, as described in section VI.A.7.f.(2)(a) of this proposed
rule; (2) Ethnicity, as described in section VI.A.7.f.(2)(a) of this
proposed rule; (3) Preferred Language, as described in section
VI.A.7.f.(2)(b) of this proposed rule; (4) Interpreter Services as
described in section VI.A.7.f.(2)(b) of this proposed rule; (5) Health
Literacy, as described in section VI.A.7.f.(2)(c) of this proposed
rule; (6) Transportation, as described in section VI.A.7.f.(2)(d) of
this proposed rule; and (5) Social Isolation, as described in section
VI.A.7.f.(2)(e) of this proposed rule. These data elements are
discussed in more detail below in section VI.A.7.f.(2) of this proposed
rule. We welcome comment on this proposal.
(2) Standardized Patient Assessment Data
Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to
collect SPADEs with respect to other categories deemed necessary and
appropriate. Below we are proposing to create a Social Determinants of
Health SPADE category under section 1899B(b)(1)(B)(vi) of the Act. In
addition to collecting SDOH data for the purposes outlined above under
section 2(d)(2)(B) of the IMPACT Act, we are also proposing to collect
as SPADE these same data elements (race, ethnicity, preferred language,
interpreter services, health literacy, transportation, and social
isolation) under section 1899B(b)(1)(B)(vi) of the Act. We believe that
this proposed new category of Social Determinants of Health will inform
provider understanding of individual patient risk factors and treatment
preferences, facilitate coordinated care and care planning, and improve
patient outcomes. We are proposing to deem this category necessary and
appropriate, for the purposes of SPADE, because using common standards
and definitions for
[[Page 17673]]
PAC data elements is important in ensuring interoperable exchange of
longitudinal information between PAC providers and other providers to
facilitate coordinated care, continuity in care planning, and the
discharge planning process from post-acute care settings.
All of the Social Determinants of Health data elements we are
proposing under section 1899B(b)(1)(B)(vi) of the Act have the capacity
to take into account treatment preferences and care goals of residents
and patients, and to inform our understanding of resident and patient
complexity and risk factors that may affect care outcomes. While
acknowledging the existence and importance of additional SDOH, we are
proposing to assess some of the factors relevant for patients and
residents receiving post-acute care that PAC settings are in a position
to impact through the provision of services and supports, such as
connecting patients and residents with identified needs with
transportation programs, certified interpreters, or social support
programs.
As previously mentioned and described in more detail below we are
proposing to adopt the following seven data elements as SPADE under the
proposed Social Determinants of Health category: Race, ethnicity,
preferred language, interpreter services, health literacy,
transportation, and social isolation. To select these data elements, we
reviewed the research literature, a number of validated assessment
tools and frameworks for addressing SDOH currently in use (for example,
Health Leads, NASEM, Protocol for Responding to and Assessing Patients'
Assets, Risks, and Experiences (PRAPARE), and ICD-10), and we engaged
in discussions with stakeholders. We also prioritized balancing the
reporting burden for PAC providers with our policy objective to collect
SPADEs that will inform care planning and coordination and quality
improvement across care settings. Furthermore, incorporating SDOH data
elements into care planning has the potential to reduce readmissions
and help beneficiaries achieve and maintain their health goals.
We also considered feedback received during a listening session
that we held on December 13, 2018. The purpose of the listening session
was to solicit feedback from health systems, research organizations,
advocacy organizations and state agencies, and other members of the
public on collecting patient-level data on SDOH across care settings,
including consideration of race, ethnicity, spoken language, health
literacy, social isolation, transportation, sex, gender identity, and
sexual orientation. We also gave participants an option to submit
written comments. A full summary of the listening session, titled
``Listening Session on Social Determinants of Health Data Elements:
Summary of Findings,'' includes a list of participating stakeholders
and their affiliations, and is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(a) Race and Ethnicity
The persistence of racial and ethnic disparities in health and
health care is widely documented, including in PAC
settings.148 149 150 151 152 Despite the trend toward
overall improvements in quality of care and health outcomes, the Agency
for Healthcare Research and Quality, in its National Healthcare Quality
and Disparities Reports, consistently indicates that racial and ethnic
disparities persist, even after controlling for factors such as income,
geography, and insurance.\153\ For example, racial and ethnic
minorities tend to have higher rates of infant mortality, diabetes and
other chronic conditions, and visits to the emergency department, and
lower rates of having a usual source of care and receiving
immunizations such as the flu vaccine.\154\ Studies have also shown
that African Americans are significantly more likely than white
Americans to die prematurely from heart disease and stroke.\155\
However, our ability to identify and address racial and ethnic health
disparities has historically been constrained by data limitations,
particularly for smaller populations groups such as Asians, American
Indians and Alaska Natives, and Native Hawaiians and other Pacific
Islanders.\156\
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\148\ 2017 National Healthcare Quality and Disparities Report.
Rockville, MD: Agency for Healthcare Research and Quality; September
2018. AHRQ Pub. No. 18-0033-EF.
\149\ Fiscella, K. and Sanders, M.R. Racial and Ethnic
Disparities in the Quality of Health Care. (2016). Annual Review of
Public Health. 37:375-394.
\150\ 2018 National Impact Assessment of the Centers for
Medicare & Medicaid Services (CMS) Quality Measures Reports.
Baltimore, MD: U.S. Department of Health and Human Services, Centers
for Medicare and Medicaid Services; February 28, 2018.
\151\ Smedley, B.D., Stith, A.Y., & Nelson, A.R. (2003). Unequal
treatment: confronting racial and ethnic disparities in health care.
Washington, DC, National Academy Press.
\152\ Chase, J., Huang, L. and Russell, D. (2017). Racial/ethnic
disparities in disability outcomes among post-acute home care
patients. J of Aging and Health. 30(9):1406-1426.
\153\ National Healthcare Quality and Disparities Reports.
(December 2018). Agency for Healthcare Research and Quality,
Rockville, MD. https://www.ahrq.gov/research/findings/nhqrdr/.
\154\ National Center for Health Statistics. Health, United
States, 2017: With special feature on mortality. Hyattsville,
Maryland. 2018.
\155\ HHS. Heart disease and African Americans. 2016b. (October
24, 2016). https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
\156\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Population Health and Public
Health Practice; Committee on Community-Based Solutions to Promote
Health Equity in the United States; Baciu A, Negussie Y, Geller A,
et al., editors. Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The
State of Health Disparities in the United States. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
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The ability to improve understanding of and address racial and
ethnic disparities in PAC outcomes requires the availability of better
data. There is currently a Race and Ethnicity data element, collected
in the MDS, LCDS, IRF-PAI, and OASIS, that consists of a single
question, which aligns with the 1997 Office of Management and Budget
(OMB) minimum data standards for federal data collection efforts.\157\
The 1997 OMB Standard lists five minimum categories of race: (1)
American Indian or Alaska Native; (2) Asian; (3) Black or African
American; (4) Native Hawaiian or Other Pacific Islander; (5) and White.
The 1997 OMB Standard also lists two minimum categories of ethnicity:
(1) Hispanic or Latino, and (2) Not Hispanic or Latino. The 2011 HHS
Data Standards requires a two-question format when self-identification
is used to collect data on race and ethnicity. Large federal surveys
such as the National Health Interview Survey, Behavioral Risk Factor
Surveillance System, and the National Survey on Drug Use and Health,
have implemented the 2011 HHS race and ethnicity data standards. CMS
has similarly updated the Medicare Current Beneficiary Survey, Medicare
Health Outcomes Survey, and the Health Insurance Marketplace
Application for Health Coverage with the 2011 HHS data standards. More
information about the HHS Race and Ethnicity Data Standards are
available on the website at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
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\157\ ``Revisions to the Standards for the Classification of
Federal Data on Race and Ethnicity (Notice of Decision)''. Federal
Register 62:210 (October 30, 1997) pp. 58782-58790. Available from:
https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf.
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We are proposing to revise the current Race and Ethnicity data
element for purposes of this proposal to conform to the 2011 HHS Data
Standards for person-level data collection, while also meeting the 1997
OMB minimum data
[[Page 17674]]
standards for race and ethnicity. Rather than one data element that
assesses both race and ethnicity, we are proposing two separate data
elements: One for Race and one for Ethnicity, that would conform with
the 2011 HHS Data Standards and the 1997 OMB Standard. In accordance
with the 2011 HHS Data Standards, a two-question format would be used
for the proposed race and ethnicity data elements.
The proposed Race data element asks, ``What is your race?'' We are
proposing to include fourteen response options under the race data
element: (1) White; (2) Black or African American; (3) American Indian
or Alaska Native; (4) Asian Indian; (5) Chinese; (6) Filipino; (7)
Japanese; (8) Korean; (9) Vietnamese; (10) Other Asian; (11) Native
Hawaiian; (12) Guamanian or Chamorro; (13) Samoan; and, (14) Other
Pacific Islander.
The proposed Ethnicity data element asks, ``Are you Hispanic,
Latino/a, or Spanish origin?'' We are proposing to include five
response options under the ethnicity data element: (1) Not of Hispanic,
Latino/a, or Spanish origin; (2) Mexican, Mexican American, Chicano/a;
(3) Puerto Rican; (4) Cuban; and, (5) Another Hispanic, Latino, or
Spanish Origin.
We believe that the two proposed data elements for race and
ethnicity conform to the 2011 HHS Data Standards for person-level data
collection, while also meeting the 1997 OMB minimum data standards for
race and ethnicity, because under those standards, more detailed
information on population groups can be collected if those additional
categories can be aggregated into the OMB minimum standard set of
categories.
In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the importance of improving response
options for race and ethnicity as a component of health care
assessments and for monitoring disparities. Some stakeholders
emphasized the importance of allowing for self-identification of race
and ethnicity for more categories than are included in the 2011 HHS
Standard to better reflect state and local diversity, while
acknowledging the burden of coding an open-ended health care assessment
question across different settings.
We believe that the proposed modified race and ethnicity data
elements more accurately reflect the diversity of the U.S. population
than the current race/ethnicity data element included in MDS, LCDS,
IRF-PAI and, OASIS.158 159 160 161 We believe, and research
consistently shows, that improving how race and ethnicity data are
collected is an important first step in improving quality of care and
health outcomes. Addressing disparities in access to care, quality of
care, and health outcomes for Medicare beneficiaries begins with
identifying and analyzing how SDOH, such as race and ethnicity, align
with disparities in these areas.\162\ Standardizing self-reported data
collection for race and ethnicity allows for the equal comparison of
data across multiple healthcare entities.\163\ By collecting and
analyzing these data, CMS and other healthcare entities will be able to
identify challenges and monitor progress. The growing diversity of the
US population and knowledge of racial and ethnic disparities within and
across population groups supports the collection of more granular data
beyond the 1997 OMB minimum standard for reporting categories. The 2011
HHS race and ethnicity data standard includes additional detail that
may be used by PAC providers to target quality improvement efforts for
racial and ethnic groups experiencing disparate outcomes. For more
information on the Race and Ethnicity data elements, we refer readers
to the document titled ``Proposed Specifications for SNF QRP Measures
and Standardized Patient Assessment Data Elements,'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\158\ Penman-Aguilar, A., Talih, M., Huang, D., Moonesinghe, R.,
Bouye, K., Beckles, G. (2016). Measurement of Health Disparities,
Health Inequities, and Social Determinants of Health to Support the
Advancement of Health Equity. J Public Health Manag Pract. 22 Suppl
1: S33-42.
\159\ Ramos, R., Davis, J.L., Ross, T., Grant, C.G., Green, B.L.
(2012). Measuring health disparities and health inequities: do you
have REGAL data? Qual Manag Health Care. 21(3):176-87.
\160\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
\161\ ``Revision of Standards for Maintaining, Collecting, and
Presenting Federal Data on Race and Ethnicity: Proposals From
Federal Interagency Working Group (Notice and Request for
Comments).'' Federal Register 82: 39 (March 1, 2017) p. 12242.
\162\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Population Health and Public
Health Practice; Committee on Community-Based Solutions to Promote
Health Equity in the United States; Baciu A, Negussie Y, Geller A,
et al., editors. Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The
State of Health Disparities in the United States. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
\163\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
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In an effort to standardize the submission of race and ethnicity
data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in
section 1899B(a)(1)(B) of the Act, while minimizing the reporting
burden, we are proposing to adopt the Race and Ethnicity data elements
described above as SPADEs with respect to the proposed Social
Determinants of Health category.
Specifically, we are proposing to replace the current Race/
Ethnicity data element with the proposed Race and Ethnicity data
elements on the MDS. We are also proposing that SNFs that submit the
Race and Ethnicity data elements with respect to admission will be
considered to have submitted with respect to discharge as well, because
it is unlikely that the results of these assessment findings will
change between the start and end of the SNF stay, making the
information submitted with respect to a resident's admission the same
with respect to a resident's discharge.
(b) Preferred Language and Interpreter Services
More than 64 million Americans speak a language other than English
at home, and nearly 40 million of those individuals have limited
English proficiency (LEP).\164\ Individuals with LEP have been shown to
receive worse care and have poorer health outcomes, including higher
readmission rates.165 166 167 Communication with individuals
with LEP is an important component of high quality health care, which
starts by understanding the population in need of language services.
Unaddressed language barriers between a patient and provider care team
negatively affects the ability to identify and address individual
medical and non-medical care needs, to convey and understand clinical
information, as well as discharge and follow up instructions, all of
which are necessary for providing
[[Page 17675]]
high quality care. Understanding the communication assistance needs of
residents and patients with LEP, including individuals who are Deaf or
hard of hearing, is critical for ensuring good outcomes.
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\164\ U.S. Census Bureau, 2013-2017 American Community Survey 5-
Year Estimates.
\165\ Karliner LS, Kim SE, Meltzer DO, Auerbach AD. Influence of
language barriers on outcomes of hospital care for general medicine
inpatients. J Hosp Med. 2010 May-Jun;5(5):276-82. doi: 10.1002/
jhm.658.
\166\ Kim EJ, Kim T, Paasche-Orlow MK, et al. Disparities in
Hypertension Associated with Limited English Proficiency. J Gen
Intern Med. 2017 Jun;32(6):632-639. doi: 10.1007/s11606-017-3999-9.
\167\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Washington, DC: The National
Academies Press.
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Presently, the preferred language of residents and patients and
need for interpreter services are assessed in two PAC assessment tools.
The LCDS and the MDS use the same two data elements to assess preferred
language and whether a patient or resident needs or wants an
interpreter to communicate with health care staff. The MDS initially
implemented preferred language and interpreter services data elements
to assess the needs of SNF residents and patients and inform care
planning. For alignment purposes, the LCDS later adopted the same data
elements for LTCHs. The 2009 NASEM (formerly Institute of Medicine)
report on standardizing data for health care quality improvement
emphasizes that language and communication needs should be assessed as
a standard part of health care delivery and quality improvement
strategies.\168\
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\168\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
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In developing our proposal for a standardized language data element
across PAC settings, we considered the current preferred language and
interpreter services data elements that are in LCDS and MDS. We also
considered the 2011 HHS Primary Language Data Standard and peer-
reviewed research. The current preferred language data element in LCDS
and MDS asks, ``What is your preferred language?'' Because the
preferred language data element is open-ended, the patient or resident
is able to identify their preferred language, including American Sign
Language (ASL). Finally, we considered the recommendations from the
2009 NASEM (formerly Institute of Medicine) report, ``Race, Ethnicity,
and Language Data: Standardization for Health Care Quality
Improvement.'' In it, the committee recommended that organizations
evaluating a patient's language and communication needs for health care
purposes, should collect data on the preferred spoken language and on
an individual's assessment of his/her level of English proficiency.
A second language data element in LCDS and MDS asks, ``Do you want
or need an interpreter to communicate with a doctor or health care
staff?'' and includes yes or no response options. In contrast, the 2011
HHS Primary Language Data Standard recommends either a single question
to assess how well someone speaks English or, if more granular
information is needed, a two-part question to assess whether a language
other than English is spoken at home and if so, identify that language.
However, neither option allows for a direct assessment of a patient's
or resident's preferred spoken or written language nor whether they
want or need interpreter services for communication with a doctor or
care team, both of which are an important part of assessing resident
and patient needs and the care planning process. More information about
the HHS Data Standard for Primary Language is available on the website
at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
Research consistently recommends collecting information about an
individual's preferred spoken language and evaluating those responses
for purposes of determining language access needs in health care.\169\
However, using ``preferred spoken language'' as the metric does not
adequately account for people whose preferred language is ASL, which
would necessitate adopting an additional data element to identify
visual language. The need to improve the assessment of language
preferences and communication needs across PAC settings should be
balanced with the burden associated with data collection on the
provider and patient or resident. Therefore we are proposing to retain
the Preferred Language and Interpreter Services data elements currently
in use on the MDS.
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\169\ Guerino, P. and James, C. Race, Ethnicity, and Language
Preference in the Health Insurance Marketplaces 2017 Open Enrollment
Period. Centers for Medicare & Medicaid Services, Office of Minority
Health. Data Highlight: Volume 7--April 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf.
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In addition, we received feedback during the December 13, 2018
listening session on the importance of evaluating and acting on
language preferences early to facilitate communication and allowing for
patient self-identification of preferred language. Although the
discussion about language was focused on preferred spoken language,
there was general consensus among participants that stated language
preferences may or may not accurately indicate the need for interpreter
services, which supports collecting and evaluating data to determine
language preference, as well as the need for interpreter services. An
alternate suggestion was made to inquire about preferred language
specifically for discussing health or health care needs. While this
suggestion does allow for ASL as a response option, we do not have data
indicating how useful this question might be for assessing the desired
information and thus we are not including this question in our
proposal.
Improving how preferred language and need for interpreter services
data are collected is an important component of improving quality by
helping PAC providers and other providers understand patient needs and
develop plans to address them. For more information on the Preferred
Language and Interpreter Services data elements, we refer readers to
the document titled ``Proposed Specifications for SNF QRP Measures and
Standardized Patient Assessment Data Elements,'' available on the
website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In an effort to standardize the submission of language data among
IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
are proposing to adopt the Preferred Language and Interpreter Services
data elements currently used on the MDS, and describe above, as SPADEs
with respect to the Social Determinants of Health category.
(c) Health Literacy
The Department of Health and Human Services defines health literacy
as ``the degree to which individuals have the capacity to obtain,
process, and understand basic health information and services needed to
make appropriate health decisions.'' \170\ Similar to language
barriers, low health literacy can interfere with communication between
the provider and resident or patient and the ability for residents and
patients or their caregivers to understand and follow treatment plans,
including medication management. Poor health literacy is linked to
lower levels of knowledge about health, worse health outcomes, and the
receipt of fewer preventive services, but higher medical costs and
rates of emergency department use.\171\
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\170\ U.S. Department of Health and Human Services, Office of
Disease Prevention and Health Promotion. National action plan to
improve health literacy. Washington (DC): Author; 2010.
\171\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Washington, DC: The National
Academies Press.
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[[Page 17676]]
Health literacy is prioritized by Healthy People 2020 as an
SDOH.\172\ Healthy People 2020 is a long-term, evidence-based effort
led by the Department of Health and Human Services that aims to
identify nationwide health improvement priorities and improve the
health of all Americans. Although not designated as a social risk
factor in NASEM's 2016 report on accounting for social risk factors in
Medicare payment, the NASEM noted that health literacy is impacted by
other social risk factors and can affect access to care as well as
quality of care and health outcomes.\173\ Assessing for health literacy
across PAC settings would facilitate better care coordination and
discharge planning. A significant challenge in assessing the health
literacy of individuals is avoiding excessive burden on patients and
residents and health care providers. The majority of existing,
validated health literacy assessment tools use multiple screening
items, generally with no fewer than four, which would make them
burdensome if adopted in MDS, LCDS, IRF-PAI, and OASIS.
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\172\ Social Determinants of Health. Healthy People 2020.
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
\173\ U.S. Department of Health & Human Services, Office of the
Assistant Secretary for Planning and Evaluation. Report to Congress:
Social Risk Factors and Performance Under Medicare's Value-Based
Purchasing Programs. Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs. Washington, DC: 2016.
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The Single Item Literacy Screener (SILS) question asks, ``How often
do you need to have someone help you when you read instructions,
pamphlets, or other written material from your doctor or pharmacy?''
Possible response options are: (1) Never; (2) Rarely; (3) Sometimes;
(4) Often; and (5) Always. The SILS question, which assesses reading
ability, (a primary component of health literacy), tested reasonably
well against the 36 item Short Test of Functional Health Literacy in
Adults (S-TOFHLA), a thoroughly vetted and widely adopted health
literacy test, in assessing the likelihood of low health literacy in an
adult sample from primary care practices participating in the Vermont
Diabetes Information System.174 175 The S-TOFHLA is a more
complex assessment instrument developed using actual hospital related
materials such as prescription bottle labels and appointment slips, and
often considered the instrument of choice for a detailed evaluation of
health literacy.\176\ Furthermore, the S-TOFHLA instrument is
proprietary and subject to purchase for individual entities or
users.\177\ Given that SILS is publicly available, shorter and easier
to administer than the full health literacy screen, and research found
that a positive result on the SILS demonstrates an increased likelihood
that an individual has low health literacy, we are proposing to use the
single-item reading question for health literacy in the standardized
data collection across PAC settings. We believe that use of this data
element will provide sufficient information about the health literacy
of SNF residents to facilitate appropriate care planning, care
coordination, and interoperable data exchange across PAC settings.
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\174\ Morris, N.S., MacLean, C.D., Chew, L.D., & Littenberg, B.
(2006). The Single Item Literacy Screener: evaluation of a brief
instrument to identify limited reading ability. BMC family practice,
7, 21. doi:10.1186/1471-2296-7-21.
\175\ Brice, J.H., Foster, M.B., Principe, S., Moss, C., Shofer,
F.S., Falk, R.J., Ferris, M.E., DeWalt, D.A. (2013). Single-item or
two-item literacy screener to predict the S-TOFHLA among adult
hemodialysis patients. Patient Educ Couns. 94(1):71-5.
\176\ University of Miami, School of Nursing & Health Studies,
Center of Excellence for Health Disparities Research. Test of
Functional Health Literacy in Adults (TOFHLA). (March 2019).
Available at https://elcentro.sonhs.miami.edu/research/measures-library/tofhla/.
\177\ Nurss, J.R., Parker, R.M., Williams, M.V., & Baker, D.W.
David W. (2001). TOFHLA. Peppercorn Books & Press. Available from:
https://www.peppercornbooks.com/catalog/information.php?info_id=5.
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In addition, we received feedback during the December 13, 2018 SDOH
listening session on the importance of recognizing health literacy as
more than understanding written materials and filling out forms, as it
is also important to evaluate whether patients and residents understand
their conditions. However, the NASEM recently recommended that health
care providers implement health literacy universal precautions instead
of taking steps to ensure care is provided at an appropriate literacy
level based on individualized assessment of health literacy.\178\ Given
the dearth of Medicare data on health literacy and gaps in addressing
health literacy in practice, we recommend the addition of a health
literacy data element.
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\178\ Hudson, S., Rikard, R.V., Staiculescu, I. & Edison, K.
(2017). Improving health and the bottom line: The case for health
literacy. In Building the case for health literacy: Proceedings of a
workshop. Washington, DC: The National Academies Press.
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The proposed Health Literacy data element is consistent with
considerations raised by NASEM and other stakeholders and research on
health literacy, which demonstrates an impact on health care use, cost,
and outcomes.\179\ For more information on the proposed Health Literacy
data element, we refer readers to the document titled ``Proposed
Specifications for SNF QRP Measures and Standardized Patient Assessment
Data Elements,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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\179\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for Social Risk Factors in Medicare Payment:
Identifying Social Risk Factors. Washington, DC: The National
Academies Press.
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In an effort to standardize the submission of health literacy data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
are proposing to adopt the SILS question, described above for the
Health Literacy data element, as SPADE under the Social Determinants of
Health Category. We are proposing to add the Health Literacy data
element to the MDS.
(d) Transportation
Transportation barriers commonly affect access to necessary health
care, causing missed appointments, delayed care, and unfilled
prescriptions, all of which can have a negative impact on health
outcomes.\180\ Access to transportation for ongoing health care and
medication access needs, particularly for those with chronic diseases,
is essential to successful chronic disease management. Adopting a data
element to collect and analyze information regarding transportation
needs across PAC settings would facilitate the connection to programs
that can address identified needs. We are therefore proposing to adopt
as SPADE a single transportation data element that is from the Protocol
for Responding to and Assessing Patients' Assets, Risks, and
Experiences (PRAPARE) assessment tool and currently part of the
Accountable Health Communities (AHC) Screening Tool.
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\180\ Syed, S.T., Gerber, B.S., and Sharp, L.K. (2013).
Traveling Towards Disease: Transportation Barriers to Health Care
Access. J Community Health. 38(5): 976-993.
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The proposed Transportation data element from the PRAPARE tool
asks, ``Has lack of transportation kept you from medical appointments,
meetings, work, or from getting things needed for daily living?'' The
three response options are: (1) Yes, it has kept me from medical
appointments or from getting my medications; (2) Yes, it has kept me
[[Page 17677]]
from non-medical meetings, appointments, work, or from getting things
that I need; and (3) No. The patient or resident would be given the
option to select all responses that apply. We are proposing to use the
transportation data element from the PRAPARE Tool, with permission from
National Association of Community Health Centers (NACHC), after
considering research on the importance of addressing transportation
needs as a critical SDOH.\181\
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\181\ Health Research & Educational Trust. (2017, November).
Social determinants of health series: Transportation and the role of
hospitals. Chicago, IL. Available at www.aha.org/transportation.www.aha.org/transportation.
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The proposed data element is responsive to research on the
importance of addressing transportation needs as a critical SDOH and
would adopt the Transportation item from the PRAPARE tool.\182\ This
data element comes from the national PRAPARE social determinants of
health assessment protocol, developed and owned by NACHC, in
partnership with the Association of Asian Pacific Community Health
Organization, the Oregon Primary Care Association, and the Institute
for Alternative Futures. Similarly the Transportation data element used
in the AHC Screening Tool was adapted from the PRAPARE tool. The AHC
screening tool was implemented by the Center for Medicare and Medicaid
Innovation's AHC Model and developed by a panel of interdisciplinary
experts that looked at evidence-based ways to measure SDOH, including
transportation. While the transportation access data element in the AHC
screening tool serves the same purposes as our proposed SPADE
collection about transportation barriers, the AHC tool has binary yes
or no response options that do not differentiate between challenges for
medical versus non-medical appointments and activities. We believe that
this is an important nuance for informing PAC discharge planning to a
community setting, as transportation needs for non-medical activities
may differ than for medical activities and should be taken into
account.\183\ We believe that use of this data element will provide
sufficient information about transportation barriers to medical and
non-medical care for SNF residents and patients to facilitate
appropriate discharge planning and care coordination across PAC
settings. As such, we are proposing to adopt the Transportation data
element from PRAPARE. More information about development of the PRAPARE
tool is available on the website at https://protect2.fireeye.com/url?k=7cb6eb44-20e2f238-7cb6da7b-0cc47adc5fa2-1751cb986c8c2f8c&u=https://www.nachc.org/prapare.
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\182\ Health Research & Educational Trust. (2017, November).
Social determinants of health series: Transportation and the role of
hospitals. Chicago, IL. Available at www.aha.org/transportation.
\183\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
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In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the impact of transportation
barriers on unmet care needs. While recognizing that there is no
consensus in the field about whether providers should have
responsibility for resolving patient transportation needs, discussion
focused on the importance of assessing transportation barriers to
facilitate connections with available community resources.
Adding a Transportation data element to the collection of SPADE
would be an important step to identifying and addressing SDOH that
impact health outcomes and patient experience for Medicare
beneficiaries. For more information on the Transportation data element,
we refer readers to the document titled ``Proposed Specifications for
SNF QRP Measures and Standardized Patient Assessment Data Elements,''
available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In an effort to standardize the submission of transportation data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
are proposing to adopt the Transportation data element described above
as SPADE with respect to the Social Determinants of Health category. If
finalized as proposed, we would add the Transportation data element to
the MDS.
(e) Social Isolation
Distinct from loneliness, social isolation refers to an actual or
perceived lack of contact with other people, such as living alone or
residing in a remote area.184 185 Social isolation tends to
increase with age, is a risk factor for physical and mental illness,
and a predictor of mortality.186 187 188 Post-acute care
providers are well-suited to design and implement programs to increase
social engagement of patients and residents, while also taking into
account individual needs and preferences. Adopting a data element to
collect and analyze information about social isolation in SNFs and
across PAC settings would facilitate the identification of residents
and patients who are socially isolated and who may benefit from
engagement efforts.
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\184\ Tomaka, J., Thompson, S., and Palacios, R. (2006). The
Relation of Social Isolation, Loneliness, and Social Support to
Disease Outcomes Among the Elderly. J of Aging and Health. 18(3):
359-384.
\185\ Social Connectedness and Engagement Technology for Long-
Term and Post-Acute Care: A Primer and Provider Selection Guide.
(2019). Leading Age. Available at https://www.leadingage.org/white-papers/social-connectedness-and-engagement-technology-long-term-and-post-acute-care-primer-and#1.1
\186\ Landeiro, F., Barrows, P., Nuttall Musson, E., Gray, A.M.,
and Leal, J. (2017). Reducing Social Loneliness in Older People: A
Systematic Review Protocol. BMJ Open. 7(5): e013778.
\187\ Ong, A.D., Uchino, B.N., and Wethington, E. (2016).
Loneliness and Health in Older Adults: A Mini-Review and Synthesis.
Gerontology. 62:443-449.
\188\ Leigh-Hunt, N., Bagguley, D., Bash, K., Turner, V.,
Turnbull, S., Valtorta, N., and Caan, W. (2017). An overview of
systematic reviews on the public health consequences of social
isolation and loneliness. Public Health. 152:157-171.
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We are proposing to adopt as SPADE a single social isolation data
element that is currently part of the AHC Screening Tool. The AHC item
was selected from the Patient-Reported Outcomes Measurement Information
System (PROMIS[supreg]) Item Bank on Emotional Distress and asks, ``How
often do you feel lonely or isolated from those around you?'' The five
response options are: (1) Never; (2) Rarely; (3) Sometimes; (4) Often;
and (5) Always.\189\ The AHC Screening Tool was developed by a panel of
interdisciplinary experts that looked at evidence-based ways to measure
SDOH, including social isolation. More information about the AHC
Screening Tool is available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
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\189\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
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In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the value of receiving information
on social isolation for purposes of care planning. Some stakeholders
also recommended assessing social isolation as an SDOH as opposed to
social support.
The proposed Social Isolation data element is consistent with NASEM
considerations about social isolation as a function of social
relationships that impacts health outcomes and increases mortality
risk, as well as the current work of a NASEM committee examining how
social isolation and loneliness impact health outcomes in adults 50
[[Page 17678]]
years and older. We believe that adding a Social Isolation data element
would be an important component of better understanding resident and
patient complexity and the care goals of residents and patients,
thereby facilitating care coordination and continuity in care planning
across PAC settings. For more information on the Social Isolation data
element, we refer readers to the document titled ``Proposed
Specifications for SNF QRP Measures and Standardized Patient Assessment
Data Elements,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
In an effort to standardize the submission of social isolation data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
are proposing to adopt the Social Isolation data element described
above as SPADE with respect to the proposed Social Determinants of
Health category. We are proposing to add the Social Isolation data
element to the MDS.
We are soliciting comment on these proposals.
8. Proposed Form, Manner, and Timing of Data Submission Under the SNF
QRP
a. Background
We refer readers to the regulatory text at Sec. 413.360(b) for
information regarding the current policies for reporting SNF QRP data.
b. Update to the CMS System for Reporting Quality Measures and
Standardized Patient Assessment Data and Associated Procedural
Proposals
SNFs are currently required to submit MDS data to CMS using the
Quality Improvement and Evaluation System (QIES) Assessment and
Submission Processing (ASAP) system. We will be migrating to a new
internet Quality Improvement and Evaluation System (iQIES) that will
enable real-time upgrades over the next few years, and we are proposing
to designate that system as the data submission system for the SNF QRP
once it becomes available, but no later than October 1, 2021.
We are proposing to revise our regulatory text at Sec. 413.360(a)
by replacing ``Certification and Survey Provider Enhanced Reports
(CASPER)'' with ``CMS designated data submission''. We are proposing to
revise our regulatory text at Sec. 413.360(d)(1) by replacing the
reference to the ``Quality Improvement Evaluation System (QIES)
Assessment Submission and Processing (ASAP)'' with ``CMS designated
data submission'' and Sec. 413.360(d)(4) by replacing the reference to
``QIES ASAP'' with ``CMS designated data submission system'' effective
October 1, 2019. In addition we are proposing to notify the public of
any future changes to the CMS designated system using subregulatory
mechanisms, such as website postings, listserv messaging, and webinars.
We invite public comments on this proposal.
c. Proposed Schedule for Reporting the Transfer of Health Information
Quality Measures Beginning With the FY 2022 SNF QRP
As discussed in section VI.A.4. of this proposed rule, we are
proposing to adopt the Transfer of Health Information to Provider-Post-
Acute Care (PAC) and Transfer of Health Information to Patient-Post-
Acute Care (PAC) quality measures beginning with the FY 2022 SNF QRP.
We also are proposing that SNFs would report the data on those measures
using the MDS. SNFs would be required to collect data on both measures
for residents beginning with October 1, 2020 discharges.
We refer readers to the FY 2018 SNF PPS final rule (82 FR 36601
through 36603) for the data collection and submission time frames that
we finalized for the SNF QRP.
We invite public comment on this proposal.
d. Proposed Schedule for Reporting Standardized Patient Assessment Data
Elements
As discussed in section VI.A.6. of this proposed rule, we are
proposing to adopt SPADEs beginning with the FY 2022 SNF QRP. We are
proposing that SNFs would report the data using the MDS. Similar to the
proposed schedule for reporting the Transfer of Health Information to
the Provider-Post-Acute Care (PAC) and Transfer of Health Information
to the Patient-Post-Acute Care (PAC) quality measures, SNFs would be
required to collect the SPADEs for residents beginning with October 1,
2020 admissions and discharges. SNFs that submit data with respect to
admission for the Hearing, Vision, Race, and Ethnicity SPADEs would be
considered to have submitted data with respect to discharges. We refer
readers to the FY 2018 SNF PPS final rule (82 FR 36601 through 36603)
for the data collection and submission time frames that we finalized
for the SNF QRP.
e. Proposed Data Reporting on Residents for the SNF Quality Reporting
Program Beginning With the FY 2022 SNF QRP
We have received public input suggesting that the quality measures
used in the SNF QRP should be calculated using data collected from all
residents receiving SNF services, regardless of the residents' payer.
This input was provided to us via comments requested about quality
measure development on the CMS Measures Management System Blueprint
website,\190\ the TEPs held by our measure development contractor,\191\
as well as through comments we received from stakeholders via our SNF
QRP mailbox, and feedback received from the NQF-convened Measure
Applications Partnership (MAP) as part of their recommendations on
Coordination Strategy for Post-Acute Care and Long-Term Care
Performance Measurement.\192\ Further, in the FY 2018 SNF PPS proposed
rule (82 FR 21077), we sought input on expanding the reporting of
quality data to include all residents, regardless of payer, so as to
ensure that the SNF QRP makes publicly available information regarding
the quality of the services furnished to the SNF population as a whole,
rather than just those residents who have Medicare.
---------------------------------------------------------------------------
\190\ Public Comment Summary Report Posting for Transfer of
Health Information and Care Preferences. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Development-of-Cross-Setting-Transfer-of-Health-Information-Quality-Meas.pdf.
\191\ Technical Expert Panel Summary Report: Development and
Maintenance of Quality Measures for Skilled Nursing Facility Quality
Reporting Program. April 2018. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/TEP-Summary-Report_April-2018_Development-and-Maintenance-of-Quality-Measures-for-SNF-QRP.pdf.
\192\ MAP Coordination Strategy for Post-Acute Care and Long-
Term Care Performance Measurement. Feb 2012. https://www.qualityforum.org/Publications/2012/02/MAP_Coordination_Strategy_for_Post-Acute_Care_and_Long-Term_Care_Performance_Measurement.aspx.
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In response to that request for public input, several commenters,
including MedPAC, submitted comments stating that they would be
supportive of an effort to collect data specified under the SNF QRP
from all SNF residents regardless of their payer. Benefits highlighted
by commenters included that such data would serve to better inform
beneficiaries on the broader quality of the entire SNF, as well as more
comprehensive quality improvement efforts across payers. MedPAC also
highlighted that while the data collection activity incurs some
[[Page 17679]]
cost, some providers currently assess all residents routinely. For a
more detailed discussion we refer readers to the FY 2018 final rule (82
FR 36603 through 36604).
Further, we believe that the most accurate representation of the
quality provided in SNFs to Medicare residents would be best conveyed
using data collected via the MDS on all SNF residents, regardless of
payer.
Accordingly, we are proposing that for purposes of meeting the
requirements of the SNF QRP, SNF would be required to collect and
submit MDS data on all SNF residents regardless of their payer. We
believe that this proposal will ensure that Medicare residents are
receiving the same quality of SNF care as other residents.
While we appreciate that collecting quality data on all residents
regardless of payer may create additional burden, we are aware that
many SNFs currently collect MDS data on all residents, regardless of
their payer, and that some SNFs may consider it burdensome to separate
out Medicare beneficiaries from other residents for purposes of
submitting the assessments to CMS.
We also note that collecting data on all SNF residents, regardless
of their payer, would align our data collection requirements under the
SNF QRP with the data collection requirements we have adopted for the
LTCH QRP and Hospice QRP.
This proposal, if finalized, would be effective beginning with the
FY 2022 program year.
We invite public comment on this proposal.
9. Proposed Policies Regarding Public Display of Measure Data for the
SNF QRP
Section 1899B(g) of the Act requires the Secretary to establish
procedures for making the SNF QRP data available to the public after
ensuring that SNFs have the opportunity to review their data prior to
public display. Measure data are currently displayed on the Nursing
Home Compare website, an interactive web tool that assists individuals
by providing information on SNF quality of care. For more information
on Nursing Home Compare, we refer readers to the website at https://www.medicare.gov/nursinghomecompare/search.html. For a more detailed
discussion about our policies regarding public display of SNF QRP
measure data and procedures for the opportunity to review and correct
data and information, we refer readers to the FY 2017 SNF PPS final
rule (81 FR 52045 through 52048).
In this proposed rule, we are proposing to begin publicly
displaying data for the Drug Regimen Review Conducted With Follow-Up
for Identified Issues--Post Acute Care (PAC) Skilled Nursing Facility
(SNF) Quality Reporting Program (QRP) measure beginning CY 2020 or as
soon as technically feasible. We finalized the Drug Regimen Review
Conducted With Follow-Up for Identified Issues--Post Acute Care (PAC)
Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) measure
in the FY 2017 SNF PPS final rule (81 FR 52034 through 52039).
Data collection for this assessment-based measure began with
patients admitted and discharged on or after October 1, 2018. We are
proposing to display data based on four rolling quarters, initially
using discharges from January 1, 2019 through December 31, 2019
(Quarter 1 2019 through Quarter 4 2019). To ensure the statistical
reliability of the data, we are proposing that we would not publicly
report a SNF's performance on the measure if the SNF had fewer than 20
eligible cases in any four consecutive rolling quarters. SNFs that have
fewer than 20 eligible cases would be distinguished with a footnote
that states, ``The number of cases/resident stays is too small to
publicly report''. We invite public comment on our proposal.
B. Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP)
1. Background
Section 215(b) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) authorized the SNF VBP Program (the
``Program'') by adding section 1888(h) to the Act. As a prerequisite to
implementing the SNF VBP Program, in the FY 2016 SNF PPS final rule (80
FR 46409 through 46426), we adopted an all-cause, all-condition
hospital readmission measure, as required by section 1888(g)(1) of the
Act and discussed other policies to implement the Program such as
performance standards, the performance period and baseline period, and
scoring. In the FY 2017 SNF PPS final rule (81 FR 51986 through 52009),
we adopted an all-condition, risk-adjusted potentially preventable
hospital readmission measure for SNFs, as required by section
1888(g)(2) of the Act, and adopted policies on performance standards,
performance scoring, and sought comment on an exchange function
methodology to translate SNF performance scores into value-based
incentive payments, among other topics. In the FY 2018 SNF PPS final
rule (82 FR 36608 through 36623), we adopted additional policies for
the Program, including an exchange function methodology for disbursing
value-based incentive payments. Additionally, in the FY 2019 SNF PPS
final rule (83 FR 39272 through 39282), we adopted more policies for
the Program, including a scoring adjustment for low-volume facilities.
The SNF VBP Program applies to freestanding SNFs, SNFs affiliated
with acute care facilities, and all non-CAH swing-bed rural hospitals.
Section 1888(h)(1)(B) of the Act requires that the SNF VBP Program
apply to payments for services furnished on or after October 1, 2018.
We believe the implementation of the SNF VBP Program is an important
step towards transforming how care is paid for, moving increasingly
towards rewarding better value, outcomes, and innovations instead of
merely rewarding volume.
For additional background information on the SNF VBP Program,
including an overview of the SNF VBP Report to Congress and a summary
of the Program's statutory requirements, we refer readers to the FY
2016 SNF PPS final rule (80 FR 46409 through 46410). We also refer
readers to the FY 2017 SNF PPS final rule (81 FR 51986 through 52009)
for discussion of the policies that we adopted related to the
potentially preventable hospital readmission measure, scoring, and
other topics. We refer readers to the FY 2018 SNF PPS final rule (82 FR
36608 through 36623) for discussions of the policies that we adopted
related to value-based incentive payments, the exchange function, and
other topics. Finally, we refer readers to the FY 2019 SNF PPS final
rule (83 FR 39272 through 39282), where we adopted a corrections policy
for numerical values of performance standards, a scoring adjustment for
low-volume facilities, and addressed other topics.
2. Measures
a. Background
For background on the measures we have adopted for the SNF VBP
Program, we refer readers to the FY 2016 SNF PPS final rule (80 FR
46419), where we finalized the Skilled Nursing Facility 30-Day All-
Cause Readmission Measure (SNFRM) (NQF #2510) that we are currently
using for the SNF VBP Program. We also refer readers to the FY 2017 SNF
PPS final rule (81 FR 51987 through 51995), where we finalized the
Skilled Nursing Facility 30-Day Potentially Preventable Readmission
Measure (SNFPPR) that we will use for the SNF VBP Program instead of
the
[[Page 17680]]
SNFRM as soon as practicable, as required by statute.
b. SNFPPR Update--Change of Measure Name
In the FY 2017 SNF PPS final rule (81 FR 51987 to 51995), we
adopted the SNFPPR as the SNF all-condition risk-adjusted potentially
preventable hospital readmission measure for the SNF VBP Program to
meet the requirements in section 1888(g)(2) of the Act. This claims-
based measure assesses the facility-level risk-standardized rate of
unplanned, potentially preventable hospital readmissions for SNF
patients within 30 days of discharge from a prior admission to an
Inpatient Prospective Payment System (IPPS) hospital, CAH, or
psychiatric hospital. However, we have not yet transitioned the SNF VBP
Program to using the SNFPPR.
The SNFPPR is one of two potentially preventable readmission
measures specified for use in the SNF setting. The SNFPPR is specified
for use for the SNF VBP Program and a second measure, the Potentially
Preventable 30-Day Post-Discharge Readmission Measure for Skilled
Nursing Facility Quality Reporting Program, is specified for use in the
SNF QRP. While these two measures are aligned in terms of exclusion
criteria and risk adjustment approach, they differ in their readmission
windows. The SNFPPR utilizes a 30-day post-hospital discharge
readmission window whereas the SNF QRP potentially preventable
readmission measure utilizes a 30-day post-SNF discharge readmission
window, consistent with the discharge readmission window specified in
other measures we have developed with respect to domains described in
section 1899B of the Act, such as the Potentially Preventable 30-Day
Post-Discharge Readmission Measure for Inpatient Rehabilitation
Facility QRP and the Potentially Preventable 30-Day Post-Discharge
Readmission Measure for Home Health QRP.
As described in the FY 2017 SNF PPS final rule (81 FR 51992), our
rationale for having two different measures was that the readmission
window associated with each measure assesses different aspects of SNF
care. The readmission window for the SNFPPR measure was developed to
align with the SNFRM which was previously adopted for the SNF VBP
Program. Both the SNFRM and SNFPPR measure specifications, including
the readmission window, were designed to harmonize with CMS's Hospital
Wide All-Cause Unplanned Readmission (HWR) measure used in the Hospital
IQR Program. The advantage of this window is that it assesses
readmissions both during the SNF stay and post-SNF discharge for most
SNF patients, depending on the SNF length of stay (LOS).
The readmission window used for the SNF QRP measure aligns with the
readmission window used in other readmission measures for post-acute
care (PAC) providers. The focus of this post-PAC only discharge
readmission window is on assessing potentially preventable hospital
readmissions during the 30 days after discharge from the PAC provider.
While the SNFPPR and the SNF QRP potentially preventable
readmission measures assess different aspects of SNF care, we have
received stakeholder feedback that having two SNF potentially
preventable readmission measures has caused confusion. To minimize the
confusion surrounding these two different measures, we are changing the
name of the SNFPPR to Skilled Nursing Facility Potentially Preventable
Readmissions after Hospital Discharge. We believe this new measure name
will clearly differentiate the SNF VBP potentially preventable
readmission measure from the SNF QRP potentially preventable
readmission measure, thereby reducing stakeholder confusion. We intend
to submit the SNFPPR measure, hereafter referred to as the Skilled
Nursing Facility Potentially Preventable Readmissions after Hospital
Discharge measure, to the National Quality Forum (NQF) for endorsement
review as soon as that is feasible.
3. FY 2022 Performance Period and Baseline Period and for Subsequent
Years
We refer readers to the FY 2016 SNF PPS final rule (80 FR 46422)
for a discussion of our considerations for determining performance
periods under the SNF VBP Program. Based on those considerations, as
well as public comment, we adopted CY 2017 as the performance period
for the FY 2019 SNF VBP Program, with a corresponding baseline period
of CY 2015.
Additionally, in the FY 2018 SNF PPS final rule (82 FR 36613
through 36614), we adopted FY 2018 as the performance period for the FY
2020 SNF VBP Program, with a corresponding baseline period of FY 2016.
We refer readers to that rule for a discussion of the need to shift the
Program's measurement periods from the calendar year to the fiscal
year. Finally, we refer readers to the FY 2019 SNF PPS final rule (83
FR 39277 through 39278), where we adopted FY 2019 as the performance
period for the FY 2021 program year, with a corresponding baseline
period of FY 2017. In that final rule, we also adopted a policy where
we would adopt for each program year a performance period that is the
1-year period following the performance period for the previous program
year. We adopted a similar policy for the baseline period, where we
stated that we would adopt for each program year a baseline period that
is the 1-year period following the baseline period for the previous
year.
Under this policy, the performance period for the FY 2022 program
year will be FY 2020, and the baseline period will be FY 2018.
4. Performance Standards
a. Background
We refer readers to the FY 2017 SNF PPS final rule (81 FR 51995
through 51998) for a summary of the statutory provisions governing
performance standards under the SNF VBP Program and our finalized
performance standards policy, as well as the numerical values for the
achievement threshold and benchmark for the FY 2019 program year. We
also responded to public comments on these policies in that final rule.
We published the final numerical values for the FY 2020 performance
standards in the FY 2018 SNF PPS final rule (82 FR 36613) and published
the final numerical values for the FY 2021 performance standards in the
FY 2019 SNF PPS final rule (83 FR 39276). We also adopted a policy
allowing us to correct the numerical values of the performance
standards in the FY 2019 SNF PPS final rule (83 FR 39276 through
39277).
b. FY 2022 Performance Standards
As we discuss in this proposed rule, we will adopt FY 2018 as the
baseline period for the FY 2022 program year under our previously-
adopted policy of advancing the performance and baseline period for
each program year automatically.
Based on the baseline period for the FY 2022 program year, we are
estimating that the performance standards would have the numerical
values noted in Table 14. We note that these values represent estimates
based on the most recently-available data, and we will update the
numerical values in the FY 2020 SNF PPS final rule.
[[Page 17681]]
Table 14--Estimated FY 2022 SNF VBP Program Performance Standards
----------------------------------------------------------------------------------------------------------------
Achievement
Measure ID Measure description threshold Benchmark
----------------------------------------------------------------------------------------------------------------
SNFRM........................................ SNF 30-Day All-Cause 0.79476 0.83212
Readmission Measure (NQF
#2510).
----------------------------------------------------------------------------------------------------------------
5. SNF VBP Performance Scoring
We refer readers to the FY 2017 SNF PPS final rule (81 FR 52000
through 52005) for a detailed discussion of the scoring methodology
that we have finalized for the Program, along with responses to public
comments on our policies and examples of scoring calculations. We also
refer readers to the FY 2018 SNF PPS final rule (82 FR 36614 through
36616) for discussion of the rounding policy we adopted, our request
for comments on SNFs with zero readmissions, and our request for
comments on a potential extraordinary circumstances exception policy.
We also refer readers to the FY 2019 SNF PPS final rule (83 FR
39278 through 39281), where we adopted (1) A scoring policy for SNFs
without sufficient baseline period data, (2) a scoring adjustment for
low-volume SNFs, and (3) an extraordinary circumstances exception
policy.
We are not proposing any updates to SNF VBP scoring policies in
this proposed rule.
6. SNF Value-Based Incentive Payments
We refer readers to the FY 2018 SNF PPS final rule (82 FR 36616
through 36621) for discussion of the exchange function methodology that
we have adopted for the Program, as well as the specific form of the
exchange function (logistic, or S-shaped curve) that we finalized, and
the payback percentage of 60 percent. We adopted these policies for FY
2019 and subsequent fiscal years.
We also discussed the process that we undertake for reducing SNFs'
adjusted Federal per diem rates under the Medicare SNF PPS and awarding
value-based incentive payments in the FY 2019 SNF PPS final rule (83 FR
39281 through 39282).
For estimates of FY 2020 SNF VBP Program incentive payment
multipliers, we encourage SNFs to refer to FY 2019 SNF VBP Program
performance information, available at: https://data.medicare.gov/Nursing-Home-Compare/SNF-VBP-Facility-Level-Dataset/284v-j9fz. Our
analysis of historical SNF VBP data shows that the Program's incentive
payment multipliers appear to be relatively consistent over time. As a
result, we believe that the FY 2019 payment results represent our best
estimate of FY 2020 performance at this time.
We are not proposing any updates to SNF VBP payment policies in
this proposed rule. However, for the reader's information, we modeled
the estimated impacts of the low-volume adjustment policy that we
established in the FY 2019 SNF PPS final rule for FY 2020 and estimate
that the application of the low-volume adjustment policy to the FY 2020
program year would redistribute an additional $8.1 million to these
low-volume SNFs for that program year. This would increase the 60
percent payback percentage for FY 2020 by approximately 1.51 percent,
resulting in a payback percentage for FY 2020 that is 61.51 percent of
the estimated $534.1 million in withheld funds for that fiscal year.
7. Public Reporting on the Nursing Home Compare Website
a. Background
Section 1888(g)(6) of the Act requires the Secretary to establish
procedures to make SNFs' performance information on SNF VBP Program
measures available to the public on the Nursing Home Compare website or
a successor, and to provide SNFs an opportunity to review and submit
corrections to that information prior to its publication. We began
publishing SNFs' performance information on the SNFRM in accordance
with this directive and the statutory deadline of October 1, 2017.
Additionally, section 1888(h)(9)(A) of the Act requires the
Secretary to make available to the public certain information on SNFs'
performance under the SNF VBP Program, including SNF Performance Scores
and their ranking. Section 1888(h)(9)(B) of the Act requires the
Secretary to post aggregate information on the Program, including the
range of SNF Performance Scores and the number of SNFs receiving value-
based incentive payments, and the range and total amount of those
payments.
In the FY 2017 SNF PPS final rule (81 FR 52009), we discussed the
statutory requirements governing public reporting of SNFs' performance
information under the SNF VBP Program. We also sought and responded to
public comments on issues that we should consider when posting
performance information on Nursing Home Compare or a successor website.
In the FY 2018 SNF PPS final rule (82 FR 36622 through 36623), we
finalized our policy to publish SNF measure performance information
under the SNF VBP Program on Nursing Home Compare after SNFs have had
an opportunity to review and submit corrections to that information
under the two-phase Review and Corrections process that we adopted in
the FY 2017 SNF PPS final rule (81 FR 52007 through 52009) and for
which we adopted additional requirements in the FY 2018 SNF PPS final
rule. In the FY 2018 SNF PPS final rule, we also adopted requirements
to rank SNFs and adopted data elements that we will include in the
ranking to provide consumers and stakeholders with the necessary
information to evaluate SNFs' performance under the Program.
b. Public Reporting of SNF Performance Scores, Achievement and
Improvement Scores, and Ranking
As we have considered issues associated with public reporting of
SNFs' performance information on the Nursing Home Compare website, we
have identified an issue that we believe warrants additional
discussion. Specifically, we are concerned that the performance
information available for display for a specific SNF may, as a result
of the application of two policies we have finalized for the Program,
be confusing to the public. Specifically, SNFs with fewer than 25
eligible stays during the baseline period for a fiscal year will only
be scored on achievement and will not have improvement information
available for display. In addition, a SNF with fewer than 25 eligible
stays during a performance period will receive an assigned SNF
performance score for that Program year that results in a value-based
incentive payment amount equal to the adjusted federal per diem rate
that the SNF would have received for the fiscal year in the absence of
the Program.
In these cases, we do not believe it would be appropriate to
suppress the SNF's information entirely given the statutory
requirements in section 1888(h)(9)(A) of the Act to publicly report
SNF-specific information, but we are concerned about publishing
performance information that is not
[[Page 17682]]
based on enough data to convey a complete and reliable picture of a
SNF's performance for the Program year.
Based on these considerations, we propose to suppress the SNF
information available to display as follows: (1) If a SNF has fewer
than 25 eligible stays during the baseline period for a Program year,
we would not display the baseline RSRR or improvement score, though we
would still display the performance period RSRR, achievement score and
total performance score if the SNF had sufficient data during the
performance period; (2) if a SNF has fewer than 25 eligible stays
during the performance period for a Program year and receives an
assigned SNF performance score as a result, we would report the
assigned SNF performance score and we would not display the performance
period RSRR, the achievement score or improvement score; and (3) if a
SNF has zero eligible cases during the performance period for a Program
year, we would not display any information for that SNF. Based on
historical data, we estimate that approximately 16 percent of SNFs will
have fewer than 25 eligible stays during the performance period and
similarly approximately 16 percent of SNFs will have fewer than 25
stays in the baseline period for FY 2020.
We believe that this policy will ensure that we publish as much
information as possible about the SNF VBP Program's performance
assessments while ensuring that the published information is reliable
and based on a sufficient quantity of information. We further believe
that this policy will provide stakeholders with meaningful information
about SNFs' performance under the Program.
We welcome public comment on this proposal.
8. Update to Phase One Review and Correction Deadline
In the FY 2017 SNF PPS final rule (81 FR 52007 through 52009), we
adopted a two-phase review and corrections process for SNFs' quality
measure data that will be made public under section 1888(g)(6) of the
Act and SNF performance information that will be made public under
section 1888(h)(9) of the Act. We explained that we would accept
corrections to the quality measure data used to calculate the measure
rates that are included in any SNF's quarterly confidential feedback
report, and that we would provide SNFs with an annual confidential
feedback report containing the performance information that will be
made public. We detailed the process for requesting Phase One
corrections and finalized a policy whereby we would accept Phase One
corrections to any quarterly report provided during a calendar year
until the following March 31.
However, as we have continued implementation of the SNF VBP
Program, we have reconsidered what deadline would be appropriate for
the Phase One correction process. Our experience managing the 2019 SNF
VBP Program has shown that fewer than 10 facilities submitted
sufficient correction information under the Phase One correction
process after October 1, 2018 and before March 31, 2019. Additionally,
we are concerned about the effects of the March 31 deadline on value-
based incentive payment calculations since the deadline is currently 6
months after payment incentives begin. For example, performance score
reports for the FY 2019 SNF VBP Program were provided in August 2018
and incentive payments for that FY were made beginning with services
provided on October 1, 2018, but SNFs still had until March 31, 2019 to
make a correction. We believe that the March 31 deadline also creates
uncertainty for SNFs because, as shown above in the timeline that
applied to the FY 2019 Program, their payment incentives could
potentially change 6 months after they take effect. If we approve a
correction request, we then need to reprocess several months of claims
for the SNF in question and potentially need to adjust the exchange
function for the fiscal year depending on the scope of the correction
and its effects on the payback percentage pool for the fiscal year. We
do not believe these outcomes are beneficial to the Program or to SNFs
that would have less predictability about their incentive payment
percentages for the fiscal year. We believe that the lack of
predictability for SNF payment percentages might adversely impact SNF
financial planning because payment amounts would not be set for all
SNFs until after the March 31 deadline.
We believe that we can mitigate this uncertainty by adopting a 30-
day deadline for Phase One correction requests, and note that this
proposal would align the Phase One review and correction process with
the Phase Two process. Under current operations, we issue a report in
June that contains all of the underlying claim information used to
calculate the measure rate for the program year, as well as the measure
rate itself. We are proposing that SNFs would have 30 days from the
date that we issue that report to review the claims and measure rate
information and to submit to us a correction request if the SNF
believes that any of that information is inaccurate. We note that this
proposal would not preclude a SNF from submitting a correction request
for any claims for which it discovers an error prior to receiving the
June report. However, the 30 day review and correction period would
commence on the day that we issue the June report, and a SNF would not
be able to request that we correct any underlying claims or its measure
rate after the conclusion of that 30 day period.
We are proposing this deadline in lieu of the current March 31
deadline for Phase One corrections. We note that we initially proposed
to adopt a 30-day deadline for Phase One corrections in the FY 2017 SNF
PPS proposed rule (81 FR 24255), though we finalized a deadline of
March 31 following the calendar year in which we provide the report. We
adopted that extended deadline to balance our desire to ensure that
measure data are sufficiently accurate with SNFs' need for sufficient
information with which to evaluate those reports, as well as to provide
SNFs with more time to review each quarter's data. In addition, we
encouraged SNFs to review the quarterly reports provided with stay-
level information and make any corrections to claims before the
proposed deadline. However, for the reasons discussed above, we now
believe that a 30-day timeframe is sufficient for SNFs to determine if
there were errors in its measure calculation by CMS or its contractor.
We believe that this policy will ensure that the underlying claims
data that we use to calculate quality measure performance for the SNF
VBP Program will be finalized prior to their use in scoring and payment
calculations. We believe that this policy will also ensure that any
corrections submitted under Phase One do not result in changes to
quality measure data months after incentive payment calculations, which
will also avoid changes to the exchange function, and as a result,
changes to other SNFs' value-based incentive payment percentages for a
fiscal year because of data errors for any SNFs. Our experience
managing the 2019 SNF VBP Program indicates that very few SNFs would be
adversely impacted by the earlier deadline. We also seek to provide
SNFs with earlier final annual payment percentage information for their
financial planning purposes.
We welcome public comments on this proposal.
VII. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et
seq.), we are required to publish a 60-day
[[Page 17683]]
notice in the Federal Register and solicit public comment before a
``collection of information'' requirement is submitted to the Office of
Management and Budget (OMB) for review and approval. For the purposes
of the PRA and this section of the preamble, collection of information
is defined under 5 CFR 1320.3(c) of the PRA's implementing regulations.
To fairly evaluate whether an information collection should be
approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit
comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our burden estimates.
The quality, utility, and clarity of the information to be
collected.
Our effort to minimize the information collection burden
on the affected public, including the use of automated collection
techniques.
We are soliciting public comment on each of the section
3506(c)(2)(A)-required issues for the following information collection
requirements (ICRs).
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 (https://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 15 presents the mean hourly wage,
the cost of fringe benefits and overhead (calculated at 100 percent of
the mean hourly wage), and the adjusted hourly wage. The adjusted wage
is used to derive this section's average cost estimates.
Table 15--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Fringe
Occupation Mean hourly benefits and Adjusted
Occupation title code wage ($/hr) overhead ($/ hourly wage ($/
hr) hr)
----------------------------------------------------------------------------------------------------------------
Health Information Technician................... 29-2071 20.59 20.59 41.18
Registered Nurse................................ 29-1141 35.36 35.36 70.72
----------------------------------------------------------------------------------------------------------------
As indicated, we are adjusting our employee hourly wage estimates
by a factor of 100 percent. This is necessarily a rough adjustment,
both because fringe benefits and overhead costs vary significantly from
employer to employer, and because methods of estimating these costs
vary widely from study to study. Nonetheless, we believe that doubling
the mean hourly wage to help estimate the total cost is a reasonably
accurate estimation method.
B. Proposed Information Collection Requirements (ICRs)
1. ICRs Regarding the SNF Quality Reporting Program (QRP)
The following proposed changes will be submitted to OMB for
approval under control number 0938-1140 (CMS-10387). The changes would
not impose any new or revised burden. Subject to renewal, the control
number is currently set to expire on February 28, 2022. It was last
approved on February 12, 2019, and remains active.
The Minimum Data Set (MDS) is part of the process for the clinical
assessment of all SNF residents and serves multiple purposes. It is
used as a data collection tool for SNFs in the PPS to inform the
Patient Driven Payment Model (PDPM) for the purpose of reimbursement,
for the SNF QRP for the purpose of monitoring the quality of care in
SNFs, and under the requirements of Omnibus Budget Reconciliation Act
(OBRA) 1987 for the collection of data for the purposes of
comprehensive resident assessment, quality and care planning for SNF
residents.
Under sections 4204(b) and 4214(d) of OBRA 1987, requirements
related to the submission and retention of resident assessment data are
not subject to the PRA. The MDS assessments that are used to inform
payment consist of the PPS 5-day assessment, the PPS discharge
assessment, and the optional Interim Payment Assessment (IPA). The
requirements necessary to administer the payment rate methodology
described in 42 CFR 413.337 are subject to the PRA. Thus, the PPS 5-
day, PPS discharge, and IPA assessments are subject to the PRA and are
active under OMB control number 0938-1140.\193\ For the readers'
convenience, the active burden estimates are summarized below in Table
16. It is important to note that SNFs currently collect and report data
for the SNF QRP through the PPS 5-day and PPS discharge assessments,
which are the same assessments used in the PDPM. The IPA is an optional
assessment for the PDPM and is not used for the SNF QRP.
---------------------------------------------------------------------------
\193\ Available at https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201809-0938-009.
---------------------------------------------------------------------------
Section 2(a) of the IMPACT Act amended the statute by adding
section 1899B to the Act, which requires, among other things, SNFs to
report standardized patient assessment data, data on quality measures,
and data on resource use and other measures. Under section 1899B(m) of
the Act, modifications to the SNF assessment instrument, the MDS,
required to achieve standardization of patient assessment data are
exempt from PRA requirements. However, if the data elements for quality
measures and standardized patient assessment data are finalized as
proposed, then we believe that we will have met the requirements for
standardization of patient assessment data. Therefore, the exemption of
the SNF QRP from the PRA is no longer applicable such that the SNF QRP
requirements and burden will be submitted to OMB for review and
approval. The active ICR serves as the basis for which we now address
the previously exempt requirements and burden.
Under our active information collection, only the PPS 5-day and PPS
discharge assessments used in the PDPM are also used as the assessments
for collecting quality measure and standardized patient assessment data
under the SNF QRP. Our active burden sets out 51 minutes (0.85 hours)
per PPS 5-day assessment and 51 minutes per PPS discharge assessment.
Consistent with the FY 2019 SNF PPS final rule (August 8, 2018; 83 FR
39283) we continue to use the OMRA assessment (with 272 items) to
estimate the amount of time to complete a PPS assessment. This is also
consistent with our active information collection. In sections VI.A.4
and VI.A.7 of this rule, we propose to add 60.5 items across the PPS 5-
day and PPS discharge assessments. Given that the PPS OMRA item set has
272 items (as compared to the PPS discharge assessment with 143 items)
that are approved under our active collection, the added items, while
increasing burden for each of the assessments, have no impact on our
currently approved burden estimates since the active collection uses
the PPS
[[Page 17684]]
OMRA item set as a proxy for all assessments. Below, however, we are
restating such burden as a courtesy to interested parties.
When calculating the burden for each assessment, we estimate it
will take 40 minutes (0.6667 hours) at $70.72/hr for an RN to collect
the information necessary for preparing the assessment, 10 minutes
(0.1667 hours) at $55.95/hr (the average hourly wage for RN ($70.72/hr)
and health information technician ($41.18/hr)) for staff to code the
responses, and 1 minute (0.0167 hours) at $41.18/hr for a health
information technician to transmit the results. In total, we estimate
that it will take 51 minutes (0.85 hours) to complete a single PPS
assessment. Based on the adjusted hourly wages for the noted staff, we
estimate that it will cost $57.17 [($70.72/hr x 0.6667 hr) + ($55.95/hr
x 0.1667 hr) + ($41.18/hr x 0.0167 hr)] to prepare, code, and transmit
each PPS assessment.
Based on our most current data, there are 15,471 Medicare Part A
SNFs. Based on FY 2017 data, we estimate that 2,406,401 5-day PPS
assessments will be completed and submitted by Part A SNFs each year
under the PDPM and SNF QRP. We used the same number of assessments
(2,406,401) as a proxy for the number of PPS discharge assessments that
would be completed and submitted each year, since all residents who
require a 5-day PPS assessment will also require a discharge assessment
under the PDPM and SNF QRP. We use the Significant Change in Status
Assessment (SCSA) as a proxy to estimate the number of IPAs as the
criteria for completing an SCSA is similar to that for the IPA. Based
on FY 2017 data, 92,240 IPAs would be completed per year under the
PDPM.
The total number of PPS 5-day assessments, PPS discharge
assessments, and IPAs that would be completed across all facilities is
4,905,042 assessments (2,406,401 + 2,406,401 + 92,240, respectively).
The total estimated time for all assessments across all facilities is
4,169,286 hours per year (4,905,042 assessments x 0.85 hours/
assessment). For all assessments across all facilities, we estimate a
burden of $280,421,251 (4,905,042 assessments x $57.17/assessment).
Given that our proposal to add 60.5 items across the PPS 5-day and
PPS discharge assessments is accounted for by using the OMRA assessment
as a proxy for all assessments, and given that our estimate for the
number of Medicare Part A SNFs and for the number PPS 5-day and PPS
discharge assessments completed and submitted by Part A SNFs each year
remains unchanged, we are not proposing to revise or adjust any of our
active burden estimates. In this regard, we will be submitting a
revised information collection request to OMB to account for the added
items.
In section VI.A.8.b. of this proposed rule, there are no burden
implications associated with updating the data submission system to the
iQIES for the SNF QRP once it becomes available, but no later than
October 1, 2021. This designation is a replacement of the existing QIES
ASAP data submission system and imposes no additional requirements or
burden on the part of SNFs.
2. ICRs Regarding the SNF VBP Program
We are not proposing to remove, add, or revise any of our SNF VBP
measure-related requirements or burden. Because this proposed rule
would not impose any new or revised SNF VBP collection of information
requirements or burden, the rule contains no SNF-VBP related
collections of information that would be subject to OMB approval under
the authority of the PRA.
C. Summary of Proposed Requirements and Annual Burden Estimates
Table 16--Summary of Proposed Requirements and Annual Burden Estimates Under OMB Control Number 0938-1140
[CMS-10387]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number Responses (per Total Time per Total time Labor cost per hour
Program changes respondents respondent) responses response (hr) (hr) ($/hr) Total cost ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active Burden..................... 15,471 317.04 4,905,042 0.85 4,169,286 varies.............. 280,421,251
Proposed Changes.................. 0 0 0 0 0 0................... 0
---------------------------------------------------------------------------------------------------------------------
Total......................... 15,471 317.04 4,905,042 0.85 4,169,286 varies.............. 280,421,251
--------------------------------------------------------------------------------------------------------------------------------------------------------
D. Submission of PRA-Related Comments
We have submitted a copy of this proposed rule 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 our proposed information collection
requirements/burden. If you wish to comment, please identify the rule
(CMS-1718-P) along with the information collection's CMS ID number
(CMS-10387) and OMB control number (0938-1140).
To obtain copies of the supporting statement and any applicable
supplementary materials, you may make your request using one of
following:
1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
control number, and CMS document identifier 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.
VIII. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
IX. Economic Analyses
A. Regulatory Impact Analysis
1. Statement of Need
This proposed rule would update the FY 2019 SNF prospective payment
rates as required under section 1888(e)(4)(E) of the Act. It also
responds to section 1888(e)(4)(H) of the Act, which requires the
Secretary to provide for publication
[[Page 17685]]
in the Federal Register before the August 1 that precedes the start of
each FY, the unadjusted federal per diem rates, the case-mix
classification system, and the factors to be applied in making the area
wage adjustment. As these statutory provisions prescribe a detailed
methodology for calculating and disseminating payment rates under the
SNF PPS, we do not have the discretion to adopt an alternative approach
on these issues.
2. Introduction
We have examined the impacts of this proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA,
September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA, March
22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August
4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs
(January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated an economically significant
rule, under section 3(f)(1) of Executive Order 12866. Accordingly, we
have prepared a regulatory impact analysis (RIA) as further discussed
below. Also, the rule has been reviewed by OMB.
3. Overall Impacts
This proposed rule sets forth updates of the SNF PPS rates
contained in the SNF PPS final rule for FY 2019 (83 FR 39162). We
estimate that the aggregate impact will be an increase of approximately
$887 million in payments to SNFs in FY 2020, resulting from the SNF
market basket update to the payment rates. We note that these impact
numbers do not incorporate the SNF VBP reductions that we estimate will
total $527.4 million in FY 2020. We would note that events may occur to
limit the scope or accuracy of our impact analysis, as this analysis is
future-oriented, and thus, very susceptible to forecasting errors due
to events that may occur within the assessed impact time period.
In accordance with sections 1888(e)(4)(E) and 1888(e)(5) of the
Act, we update the FY 2019 payment rates by a factor equal to the
market basket index percentage change adjusted by the MFP adjustment to
determine the payment rates for FY 2020. The impact to Medicare is
included in the total column of Table 17. In updating the SNF PPS rates
for FY 2020, we made a number of standard annual revisions and
clarifications mentioned elsewhere in this proposed rule (for example,
the update to the wage and market basket indexes used for adjusting the
federal rates).
The annual update set forth in this proposed rule applies to SNF
PPS payments in FY 2020. Accordingly, the analysis of the impact of the
annual update that follows only describes the impact of this single
year. Furthermore, in accordance with the requirements of the Act, we
will publish a rule or notice for each subsequent FY that will provide
for an update to the payment rates and include an associated impact
analysis.
4. Detailed Economic Analysis
The FY 2020 SNF PPS payment impacts appear in Table 17. Using the
most recently available data, in this case FY 2018, we apply the
current FY 2019 wage index and labor-related share value to the number
of payment days to simulate FY 2019 payments. Then, using the same FY
2018 data, we apply the proposed FY 2020 wage index and labor-related
share value to simulate FY 2020 payments. We tabulate the resulting
payments according to the classifications in Table 17 (for example,
facility type, geographic region, facility ownership), and compare the
simulated FY 2019 payments to the simulated FY 2020 payments to
determine the overall impact. The breakdown of the various categories
of data Table 17 follows:
The first column shows the breakdown of all SNFs by urban
or rural status, hospital-based or freestanding status, census region,
and ownership.
The first row of figures describes the estimated effects
of the various changes on all facilities. The next six rows show the
effects on facilities split by hospital-based, freestanding, urban, and
rural categories. The next nineteen rows show the effects on facilities
by urban versus rural status by census region. The last three rows show
the effects on facilities by ownership (that is, government, profit,
and non-profit status).
The second column shows the number of facilities in the
impact database.
The third column shows the effect of the transition to
PDPM. This represents the effect on providers, assuming no changes in
behavior or case-mix, from changing the case-mix classification model
used to classify patients in a Medicare Part A SNF stay. The total
impact of this change is 0.0 percent; however, there are distributional
effects of this change.
The fourth column shows the effect of the annual update to
the wage index. This represents the effect of using the most recent
wage data available. The total impact of this change is 0.0 percent;
however, there are distributional effects of the change.
The fifth column shows the effect of all of the changes on
the FY 2020 payments. The update of 2.5 percent is constant for all
providers and, though not shown individually, is included in the total
column. It is projected that aggregate payments will increase by 2.5
percent, assuming facilities do not change their care delivery and
billing practices in response.
As illustrated in Table 17, the combined effects of all of the
changes vary by specific types of providers and by location. For
example, due to changes in this proposed rule, providers in the urban
Pacific region would experience a 1.7 percent increase in FY 2020 total
payments.
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[[Page 17686]]
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5. Estimated Impacts for the Skilled Nursing Facility (SNF) Quality
Reporting Program (QRP)
Estimated impacts for the SNF QRP are based on analysis discussed
in section VII.B.1. of this proposed rule. The proposed SNF QRP
requirements add no additional burden to the active OMB #0938-1140
(CMS-10387).
6. Impacts for the SNF VBP Program
Estimated impacts of the FY 2020 SNF VBP Program are based on
historical data and appear in Table 18. We modeled SNF performance in
the Program using SNFRM data from CY 2015 as the baseline period and CY
2017 as the performance period. Additionally, we modeled a logistic
exchange function with a payback percentage of 60 percent, as we
finalized in the FY 2018 SNF PPS final rule (82 FR 36619 through
36621), though we note that the 60 percent payback percentage for FY
2020 will adjust to account for the low-volume scoring adjustment that
we adopted in the FY 2019 SNF PPS final rule (83 FR 39278 through
39280). Based on the 60 percent payback percentage (as modified by the
low-income scoring adjustment), we estimate that we will redistribute
approximately $320.4 million in value-based incentive payments to SNFs
in FY 2020, which means that the SNF VBP Program is estimated to result
in approximately $213.6 million in savings to the Medicare Program in
FY 2020. We refer readers to the FY 2019 SNF PPS final rule (83 FR
39278 through 39280) for additional information about payment
adjustments for low-volume SNFs in the SNF VBP Program.
Our detailed analysis of the impacts of the FY 2020 SNF VBP Program
follows in Table 18.
[[Page 17687]]
[GRAPHIC] [TIFF OMITTED] TP25AP19.007
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7. Alternatives Considered
As described in this section, we estimated that the aggregate
impact for FY 2020 under the SNF PPS will be an increase of
approximately $887 million in payments to SNFs, resulting from the SNF
market basket update to the payment rates.
Section 1888(e) of the Act establishes the SNF PPS for the payment
of Medicare SNF services for cost reporting periods beginning on or
after July 1, 1998. This section of the statute prescribes a detailed
formula for calculating base payment rates under the SNF PPS, and does
not provide for the use of any alternative methodology. It specifies
that the base year cost data to be used for computing the SNF PPS
payment rates must be from FY 1995 (October 1, 1994, through September
30, 1995). In accordance with the statute, we also incorporated a
number of elements into the SNF PPS (for example, case-mix
classification methodology, a market basket index, a wage index, and
the urban and rural distinction used in the development or adjustment
of the federal rates). Further, section 1888(e)(4)(H) of the Act
specifically requires us to disseminate the payment rates for each new
FY through the Federal Register, and to do so before the August 1 that
precedes the start of the new FY; accordingly, we are not pursuing
alternatives for this process.
8. Accounting Statement
As required by OMB Circular A-4 (available online at https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/), in Tables 19 and
20, we have prepared an accounting statement showing the classification
of the expenditures associated with the provisions of this proposed
rule for FY 2020. Tables 17 and 19 provide our best estimate of the
possible changes in Medicare payments under the SNF PPS
[[Page 17688]]
as a result of the policies in this proposed rule, based on the data
for 15,078 SNFs in our database. Tables 18 and 20 provide our best
estimate of the possible changes in Medicare payments under the SNF VBP
as a result of the policies in this proposed rule.
Table 19--Accounting Statement: Classification of Estimated Expenditures, From the 2019 SNF PPS Fiscal Year to
the 2020 SNF PPS Fiscal Year
----------------------------------------------------------------------------------------------------------------
Category Transfers
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Transfers...... $887 million.*
From Whom To Whom?.................. Federal Government to SNF Medicare Providers.
----------------------------------------------------------------------------------------------------------------
* The net increase of $887 million in transfer payments is a result of the market basket increase of $887
million.
Table 20--Accounting Statement: Classification of Estimated Expenditures for the FY 2020 SNF VBP Program
----------------------------------------------------------------------------------------------------------------
Category Transfers
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Transfers...... $320.4 million.*
From Whom To Whom?.................. Federal Government to SNF Medicare Providers.
----------------------------------------------------------------------------------------------------------------
* This estimate does not include the two percent reduction to SNFs' Medicare payments (estimated to be $527.4
million) required by statute.
9. Conclusion
This proposed rule sets forth updates of the SNF PPS rates
contained in the SNF PPS final rule for FY 2019 (83 FR 39162). Based on
the above, we estimate that the overall payments for SNFs under the SNF
PPS in FY 2020 are projected to increase by approximately $887 million,
or 2.5 percent, compared with those in FY 2019. We estimate that in FY
2020 under PDPM, SNFs in urban and rural areas will experience, on
average, a 1.8 percent increase and 6.4 percent increase, respectively,
in estimated payments compared with FY 2019. Providers in the urban
Outlying region will experience the largest estimated increase in
payments of approximately 61.3 percent. Providers in the urban Middle
Atlantic region will experience the largest estimated decrease in
payments of 0.8 percent.
B. Regulatory Flexibility Act Analysis
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, non-profit organizations, and small
governmental jurisdictions. Most SNFs and most other providers and
suppliers are small entities, either by reason of their non-profit
status or by having revenues of $27.5 million or less in any 1 year. We
utilized the revenues of individual SNF providers (from recent Medicare
Cost Reports) to classify a small business, and not the revenue of a
larger firm with which they may be affiliated. As a result, for the
purposes of the RFA, we estimate that almost all SNFs are small
entities as that term is used in the RFA, according to the Small
Business Administration's latest size standards (NAICS 623110), with
total revenues of $27.5 million or less in any 1 year. (For details,
see the Small Business Administration's website at https://www.sba.gov/category/navigation-structure/contracting/contracting-officials/eligibility-size-standards). In addition, approximately 20 percent of
SNFs classified as small entities are non-profit organizations.
Finally, individuals and states are not included in the definition of a
small entity.
This proposed rule sets forth updates of the SNF PPS rates
contained in the SNF PPS final rule for FY 2019 (83 FR 39162). Based on
the above, we estimate that the aggregate impact for FY 2020 will be an
increase of $887 million in payments to SNFs, resulting from the SNF
market basket update to the payment rates. While it is projected in
Table 18 that most providers would experience a net increase in
payments, we note that some individual providers within the same region
or group may experience different impacts on payments than others due
to the distributional impact of the FY 2020 wage indexes, PDPM
transition and the degree of Medicare utilization.
Guidance issued by the Department of Health and Human Services on
the proper assessment of the impact on small entities in rulemakings,
utilizes a cost or revenue impact of 3 to 5 percent as a significance
threshold under the RFA. In their March 2019 Report to Congress
(available at https://medpac.gov/docs/default-source/reports/mar19_medpac_ch8_sec.pdf), MedPAC states that Medicare covers
approximately 11 percent of total patient days in freestanding
facilities and 19 percent of facility revenue (March 2019 MedPAC Report
to Congress, 197). As a result, for most facilities, when all payers
are included in the revenue stream, the overall impact on total
revenues should be substantially less than those impacts presented in
Table 18. As indicated in Table 18, the effect on facilities is
projected to be an aggregate positive impact of 2.5 percent for FY
2020. As the overall impact on the industry as a whole, and thus on
small entities specifically, is less than the 3 to 5 percent threshold
discussed previously, the Secretary has determined that this proposed
rule will not have a significant impact on a substantial number of
small entities for FY 2020.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of an MSA and has fewer
than 100 beds. This proposed rule will affect small rural hospitals
that (1) furnish SNF services under a swing-bed agreement or (2) have a
hospital-based SNF. We anticipate that the impact on small rural
hospitals will be a positive impact. Moreover, as noted in previous SNF
PPS final rules (most recently, the one for FY 2019 (83 FR 39288)), the
category of small rural hospitals is included within the analysis of
the impact of this proposed rule on small entities in general. As
indicated in Table 18, the effect on facilities for FY 2020 is
projected to be an aggregate positive impact of 2.5 percent. As the
overall
[[Page 17689]]
impact on the industry as a whole is less than the 3 to 5 percent
threshold discussed above, the Secretary has determined that this final
rule will not have a significant impact on a substantial number of
small rural hospitals for FY 2020.
C. Unfunded Mandates Reform Act Analysis
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2019, that
threshold is approximately $154 million. This proposed rule will impose
no mandates on state, local, or tribal governments or on the private
sector.
D. Federalism Analysis
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule (and subsequent final
rule) that imposes substantial direct requirement costs on state and
local governments, preempts state law, or otherwise has federalism
implications. This proposed rule would have no substantial direct
effect on state and local governments, preempt state law, or otherwise
have federalism implications.
E. Reducing Regulation and Controlling Regulatory Costs
Executive Order 13771 (January 30, 2017) requires that the costs
associated with significant new regulations ``to the extent permitted
by law, be offset by the elimination of existing costs associated with
at least two prior regulations.'' This proposed rule is not subject to
the requirements of E.O. 13771 because it is expected to result in no
more than de minimis costs.
F. Congressional Review Act
This proposed regulation is subject to the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress
and the Comptroller General for review.
G. Regulatory Review Costs
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this proposed rule, we
should estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review the rule, we assume that the total number of unique
commenters on last year's proposed rule will be the number of reviewers
of this year's proposed rule. We acknowledge that this assumption may
understate or overstate the costs of reviewing this rule. It is
possible that not all commenters reviewed last year's rule in detail,
and it is also possible that some reviewers chose not to comment on the
proposed rule. For these reasons, we thought that the number of past
commenters 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 will review the proposed rule.
We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of this proposed rule,
and therefore, for the purposes of our estimate we assume that each
reviewer reads approximately 50 percent of the rule. We seek comments
on this assumption.
Using the wage information from the BLS for medical and health
service managers (Code 11-9111), we estimate that the cost of reviewing
this rule is $107.38 per hour, including overhead and fringe benefits
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average
reading speed, we estimate that it would take approximately 4 hours for
the staff to review half of the proposed rule. For each SNF that
reviews the rule, the estimated cost is $429.52 (4 hours x $107.38).
Therefore, we estimate that the total cost of reviewing this regulation
is $124,561 ($429.52 x 290 reviewers).
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 409
Health facilities, Medicare.
42 CFR Part 413
Diseases, Health facilities, Medicare, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 409--HOSPITAL INSURANCE BENEFITS
0
1. The authority citation for part 409 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
Sec. 409.30 [Amended]
0
2. Section 409.30 is amended in the introductory text by removing the
phrase ``the 5-day assessment'' and adding in its place the phrase
``the initial patient assessment''.
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT
RATES FOR SKILLED NURSING FACILITIES; PAYMENT FOR ACUTE KIDNEY
INJURY DIALYSIS
0
3. The authority citation for part 413 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a),
(i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww; and sec.
124 of Public Law 106-113, 113 Stat. 1501A-332; sec. 3201 of Public
Law 112-96, 126 Stat. 156; sec. 632 of Public Law 112-240, 126 Stat.
2354; sec. 217 of Public Law 113-93, 129 Stat. 1040; and sec. 204 of
Public Law 113-295, 128 Stat. 4010; and sec. 808 of Public Law 114-
27, 129 Stat. 362.
0
4. Section 413.343 is amended by revising paragraph (b) to read as
follows:
Sec. 413.343 Resident assessment data.
* * * * *
(b) Assessment schedule. In accordance with the methodology
described in Sec. 413.337(c) related to the adjustment of the Federal
rates for case-mix, SNFs must submit assessments according to an
assessment schedule. This schedule must include performance of an
initial patient assessment no later than the 8th day of posthospital
SNF care and such other interim payment assessments as the SNF
determines are necessary to account for changes in patient care needs.
* * * * *
0
5. Section 413.360 is amended by revising paragraphs (a) and (d)(1) and
(4) to read as follows:
Sec. 413.360 Requirements under the Skilled Nursing Facility (SNF)
Quality Reporting Program (QRP).
(a) Participation start date. Beginning with the FY 2018 program
year, a SNF must begin reporting data in accordance with paragraph (b)
of this section no later than the first day of the calendar quarter
subsequent to 30 days after the date on its CMS Certification Number
(CCN) notification letter, which designates the SNF as operating in the
CMS designated data submission system. For purposes of this section, a
program year is the fiscal year in which the market basket percentage
described in Sec. 413.337(d) is reduced by two percentage points if
the SNF does not
[[Page 17690]]
report data in accordance with paragraph (b) of this section.
* * * * *
(d) * * *
(1) SNFs that do not meet the requirements in paragraph (b) of this
section for a program year will receive a notification of non-
compliance sent through at least one of the following methods: The CMS
designated data submission system, the United States Postal Service, or
via an email from the Medicare Administrative Contractor (MAC). A SNF
may request reconsideration no later than 30 calendar days after the
date identified on the letter of non-compliance.
* * * * *
(4) CMS will notify SNFs, in writing, of its final decision
regarding any reconsideration request through at least one of the
following methods: CMS designated data submission system, the United
States Postal Service, or via email from the CMS Medicare
Administrative Contractor (MAC).
* * * * *
Dated: March 26, 2019.
Seema Verma
Administrator, Centers for Medicare & Medicaid Services.
Dated: April 2, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-08108 Filed 4-19-19; 4:15 p.m.]
BILLING CODE 4120-01-P
