Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) for FY 2016, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and Staffing Data Collection, 46389-46477 [2015-18950]
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Vol. 80
Tuesday,
No. 149
August 4, 2015
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
42 CFR Part 483
Medicare Program; Prospective Payment System and Consolidated Billing
for Skilled Nursing Facilities (SNFs) for FY 2016, SNF Value-Based
Purchasing Program, SNF Quality Reporting Program, and Staffing Data
Collection; Final Rule
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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 483
[CMS–1622–F]
RIN 0938–AS44
Medicare Program; Prospective
Payment System and Consolidated
Billing for Skilled Nursing Facilities
(SNFs) for FY 2016, SNF Value-Based
Purchasing Program, SNF Quality
Reporting Program, and Staffing Data
Collection
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
This final rule updates the
payment rates used under the
prospective payment system (PPS) for
skilled nursing facilities (SNFs) for
fiscal year (FY) 2016. In addition, it
specifies a SNF all-cause all-condition
hospital readmission measure, as well
as adopts that measure for a new SNF
Value-Based Purchasing (VBP) Program,
and includes a discussion of SNF VBP
Program policies we are considering for
future rulemaking to promote higher
quality and more efficient health care
for Medicare beneficiaries. Additionally,
this final rule will implement a new
quality reporting program for SNFs as
specified in the Improving Medicare
Post-Acute Care Transformation Act of
2014 (IMPACT Act). It also amends the
requirements that a long-term care (LTC)
facility must meet to qualify to
participate as a skilled nursing facility
(SNF) in the Medicare program, or a
nursing facility (NF) in the Medicaid
program, by establishing requirements
that implement the provision in the
Affordable Care Act regarding the
submission of staffing information based
on payroll data.
DATES: Effective date: The provisions of
this final rule are effective on October
1, 2015 with the exception of provisions
in § 483.75(u) which are effective on
July 1, 2016.
FOR FURTHER INFORMATION CONTACT:
Penny Gershman, (410) 786–6643, for
information related to SNF PPS clinical
issues (excluding any issues raised in
section III.D. of this final rule).
John Kane, (410) 786–0557, for
information related to the development
of the payment rates and case-mix
indexes.
Kia Sidbury, (410) 786–7816, for
information related to the wage index.
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SUMMARY:
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Bill Ullman, (410) 786–5667, for
information related to level of care
determinations, consolidated billing,
and general information.
Shannon Kerr, (410) 786–0666, for
information related to skilled nursing
facility value-based purchasing.
Charlayne Van, (410) 786–8659, for
information related to skilled nursing
facility quality reporting.
Lorelei Chapman, (410) 786–9254, for
information related to staffing data
collection.
SUPPLEMENTARY INFORMATION:
Availability of Certain Tables
Exclusively Through the Internet on the
CMS Web Site
As discussed in the FY 2016 SNF PPS
proposed rule (80 FR 22044), 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 Web site. The wage
index tables for this final rule can be
accessed on the SNF PPS Wage Index
homepage, 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
II. Background on SNF PPS
A. Statutory Basis and Scope
B. Initial Transition for the SNF PPS
C. Required Annual Rate Updates
III. Analysis of and Responses to Public
Comments on the FY 2016 SNF PPS
Proposed Rule
A. General Comments on the FY 2016 SNF
PPS Proposed Rule
B. SNF PPS Rate Setting Methodology and
FY 2016 Update
1. Federal Base Rates
2. SNF Market Basket Update
a. SNF Market Basket Index
b. Use of the SNF Market Basket Percentage
c. Forecast Error Adjustment
d. Multifactor Productivity Adjustment
(1) Incorporating the Multifactor
Productivity Adjustment Into the Market
Basket Update
e. Market Basket Update Factor for FY 2016
3. Case-Mix Adjustment
4. Wage Index Adjustment
5. Adjusted Rate Computation Example
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C. Additional Aspects of the SNF PPS
1. SNF Level of Care—Administrative
Presumption
2. Consolidated Billing
3. Payment for SNF-Level Swing-Bed
Services
D. Other Issues
1. SNF Value-Based Purchasing (VBP)
Program
a. Background
(1) Overview
(2) SNF VBP Report to Congress
b. Statutory Basis for the SNF VBP Program
c. Skilled Nursing Facility 30-Day AllCause Readmission Measure (SNFRM)
(1) Overview
(2) Measure Calculation
(3) Exclusions
(4) Eligible Readmissions
(5) Risk Adjustment
(6) Measurement Period
(7) Stakeholder/MAP Input
(8) Feedback Reports to SNFs
d. Performance Standards
(1) Background
(a) Hospital Value-Based Purchasing
Program
(b) Hospital-Acquired Conditions
Reduction Program
(c) Hospital Readmissions Reduction
Program (HRRP)
(d) End-Stage Renal Disease Quality
Incentive Program (ESRD QIP)
(2) Measuring Improvement
e. FY 2019 Performance Period and
Baseline Period Considerations
(1) Performance Period
(2) Baseline Period
f. SNF Performance Scoring
(1) Considerations
(a) Hospital Value-Based Purchasing
(b) Hospital-Acquired Conditions
Reduction Program
(c) Other Considerations
(2) Notification Procedures
(3) Exchange Function
g. SNF Value-Based Incentive Payments
h. SNF VBP Public Reporting
(1) SNF-Specific Performance Information
(2) Aggregate Performance Information
2. Advancing Health Information Exchange
3. SNF Quality Reporting Program (QRP)
a. Background and Statutory Authority
b. General Considerations Used for
Selection of Quality Measures for the
SNF QRP
c. Policy for Retaining SNF QRP Measures
for Future Payment Determinations
d. Process for Adoption of Changes to SNF
QRP Program Measures
e. New Quality Measures for FY 2018 and
Subsequent Payment Determinations
(1) Quality Measure Addressing the
Domain of Skin Integrity and Changes in
Skin Integrity: Percent of Residents or
Patients With Pressure Ulcers That are
New or Worsened (Short Stay) (NQF
#0678)
(2) Quality Measure Addressing the
Domain of the Incidence of Major Falls:
An Application of the Measure Percent
of Residents Experiencing One or More
Falls With Major Injury (Long Stay)
(NQF #0674)
(3) Quality Measure Addressing the
Domain of Functional Status, Cognitive
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Function, and Changes in Function and
Cognitive Function: 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; under NQF review)
f. SNF QRP Quality Measures Under
Consideration for Future Years
g. Form, Manner, and Timing of Quality
Data Submission
(1) Participation/Timing for New SNFs
(2) Data Collection Timelines and
Requirements for the FY 2018 Payment
Determination and Subsequent Years
h. SNF QRP Data Completion Thresholds
for FY 2018 Payment Determination and
Subsequent Years
i. SNF QRP Data Validation Requirements
for the FY 2018 Payment Determination
and Subsequent Years
j. SNF QRP Submission Exception and
Extension Requirements for the FY 2018
Payment Determination and Subsequent
Years
k. SNF QRP Reconsideration and Appeals
Procedures for the FY 2018 Payment
Determination and Subsequent Years
l. Public Display of Quality Measure Data
for the SNF QRP
m. Mechanism for Providing Feedback
Reports to SNFs
4. Staffing Data Collection
a. Background and Statutory Authority
b. Provisions of the Proposed Rule and
Responses to Comments
(1) Consultation on Specifications
(2) Scope of Submission Requirements
(3) Hours Worked and Hours of Care
(4) Distinguishing Employees From Agency
and Contract Staff
(5) Data Format
(6) Effective Date for Submission
Requirement
(7) Submission Schedule
(8) Compliance and Enforcement
(9) Other Comments
c. Provisions of the Final Rule
IV. Collection of Information Requirements
V. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
2. Statement of Need
3. Overall Impacts
4. Detailed Economic Analysis
5. Alternatives Considered
6. Accounting Statement
7. Conclusion
B. Regulatory Flexibility Act Analysis
C. Unfunded Mandates Reform Act
Analysis
D. Federalism Analysis
E. Congressional Review Act
Regulation Text
Acronyms
In addition, because of the many
terms to which we refer by acronym in
this final rule, we are listing these
abbreviations and their corresponding
terms in alphabetical order below:
AIDS Acquired Immune Deficiency
Syndrome
ARD Assessment reference date
BBA Balanced Budget Act of 1997, Pub. L.
105–33
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BBRA Medicare, Medicaid, and SCHIP
Balanced Budget Refinement Act of
1999, Public Law 106–113
BIPA Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection
Act of 2000, Public Law 106–554
CAH Critical access hospital
CASPER Certification and Survey Provider
Enhanced Reports
CBSA Core-based statistical area
CCN CMS Certification Number
CFR Code of Federal Regulations
CMI Case-mix index
CMS Centers for Medicare & Medicaid
Services
COT Change of therapy
ECI Employment Cost Index
EHR Electronic health record
EOT End of therapy
EOT–R End of therapy—resumption
ESRDQIP End-Stage Renal Disease Quality
Incentive Program
FAQ Frequently Asked Questions
FFS Fee-for-service
FR Federal Register
FY Fiscal year
GAO Government Accountability Office
HAC Hospital-Acquired Conditions
HACRP Hospital-Acquired Condition
Reduction Program
HCPCS Healthcare Common Procedure
Coding System
HIQR Hospital Inpatient Quality Reporting
HOQR Hospital Outpatient Quality
Reporting
HRRP Hospital Readmissions Reduction
Program
HVBP Hospital Value-Based Purchasing
ICR Information Collection Requirements
IGI IHS (Information Handling Services)
Global Insight, Inc.
IMPACT Improving Medicare Post-Acute
Care Transformation Act of 2014, Public
Law 113–185
IPPS Inpatient prospective payment system
IRF Inpatient Rehabilitation Facility
LTC Long-term care
LTCH Long-term care hospital
MAP Measures Application Partnership
MDS Minimum data set
MFP Multifactor productivity
MMA Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173
MSA Metropolitan statistical area
NAICS North American Industrial
Classification System
NF Nursing facility
NH Nursing Home
NQF National Quality Forum
OBRA Omnibus Budget Reconciliation Act
of 1987, Public Law 100–203
OMB Office of Management and Budget
OMRA Other Medicare-Required
Assessment
PAC Post-acute care
PAMA Protecting Access to Medicare Act of
2014, Public Law 113–93
PBJ Payroll-Based Journal
PPS Prospective Payment System
PQRS Physician Quality Reporting System
QIES Quality Improvement Evaluation
System
QIES ASAP Quality Improvement and
Evaluation System Assessment
Submission and Processing
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QRP Quality Reporting Program
RAI Resident assessment instrument
RAVEN Resident assessment validation
entry
RFA Regulatory Flexibility Act, Public Law
96–354
RIA Regulatory impact analysis
RUG–III Resource Utilization Groups,
Version 3
RUG–IV Resource Utilization Groups,
Version 4
RUG–53 Refined 53-Group RUG–III CaseMix Classification System
SCHIP State Children’s Health Insurance
Program
sDTI Suspected deep tissue injuries
SNF Skilled nursing facility
SNFRM Skilled Nursing Facility 30-Day
All-Cause Readmission Measure
STM Staff time measurement
STRIVE Staff time and resource intensity
verification
TEP Technical expert panel
UMRA Unfunded Mandates Reform Act,
Public Law 104–4
VBP Value-based purchasing
I. Executive Summary
A. Purpose
This final rule updates the SNF
prospective payment rates for FY 2016
as required under section 1888(e)(4)(E)
of the Social Security Act (the Act). It
also responds 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 fiscal year
(FY), certain specified information
relating to the payment update (see
section II.C.). In addition, it implements
a new quality reporting program (QRP)
for SNFs required under section
1888(e)(6) of the Act. The final rule also
specifies a SNF all-cause all-condition
hospital readmission measure required
under section 1888(g)(1) of the Act, and
adopts that measure for a new SNF
value-based purchasing (VBP) program
as required under section 1888(h) of the
Act. Further, this final rule establishes
new regulatory reporting requirements
for SNFs and NFs to implement the
statutory obligation to submit staffing
information based on payroll data under
section 1128I(g) of the Act.
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 final
rule reflect an update to the rates that
we published in the SNF PPS final rule
for FY 2015 (79 FR 45628), which
reflects the SNF market basket index as
adjusted by the applicable forecast error
correction and by the multifactor
productivity adjustment for FY 2016.
We are also finalizing a SNF all-cause
all-condition hospital readmission
measure under section 1888(g)(1) of the
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Act, as well as adopting that measure for
a new SNF VBP Program as required
under section 1888(h) of the Act. We are
also implementing a new QRP for SNFs
under section 1888(e)(6) of the Act,
which was added by section 2(c)(4) of
the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT
Act, Pub. L. 113–185).
For payment determinations
beginning with FY 2018, we are
adopting measures meeting three quality
domains specified in section
1899B(c)(1) of the Act: Functional
status, skin integrity, and incidence of
major falls.
In addition, we are adding new
language at 42 CFR, part 483 to
implement section 1128I(g) of the Act.
Specifically, beginning on July 1, 2016,
long-term care (LTC) facilities that
participate in Medicare or Medicaid will
be required to submit electronically
direct care staffing information
(including information for agency and
contract staff) based on payroll and
other verifiable and auditable data in a
uniform format.
C. Summary of Cost and Benefits
Provision
description
Total transfers
FY 2016 SNF
PPS payment rate
update.
The overall economic impact
of this final rule will be an
estimated increase of
$430 million in aggregate
payments to SNFs during
FY 2016.
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II. Background on SNF PPS
A. Statutory Basis and Scope
As amended by section 4432 of the
Balanced Budget Act of 1997 (BBA, Pub.
L. 105–33), 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
physician services) for which payment
may otherwise be made under Part B
and which are furnished to Medicare
beneficiaries who are residents in a SNF
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during a covered Part A stay. A
comprehensive discussion of these
provisions appears in the May 12, 1998
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-ServicePayment/SNFPPS/Downloads/
Legislative_History_07302013.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 certain
quality measures 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(a) of the IMPACT Act added section
1899B to the Act that, among other
things, requires SNFs to report
standardized data for measures in
specified quality and resource use
domains. In addition, the IMPACT Act
added section 1888(e)(6) to the Act,
which requires the Secretary to
implement a QRP for SNFs, under
which SNFs that do not report certain
data will receive a reduction in their
payments under the SNF PPS of 2
percentage points for FYs beginning
with FY 2018.
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 three 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 facilityspecific 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 2015 (79 FR
45628, August 5, 2014).
Section 1888(e)(4)(H) of the Act
specifies that we provide for publication
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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 final rule
provides the required annual updates to
the per diem payment rates for SNFs for
FY 2016.
III. Analysis of and Responses to Public
Comments on the FY 2016 SNF PPS
Proposed Rule
In response to the publication of the
FY 2016 SNF PPS proposed rule, we
received 53 timely public comments
from individuals, providers,
corporations, government agencies,
private citizens, trade associations, and
major organizations. The following are
brief summaries of each proposed
provision, a summary of the public
comments that we received related to
that proposal, and our responses to the
comments.
A. General Comments on the FY 2016
SNF PPS Proposed Rule
In addition to the comments we
received on specific proposals
contained within the proposed rule
(which we address later in this final
rule), commenters also submitted the
following, more general observations on
the SNF PPS and SNF care generally. A
discussion of these comments, along
with our responses, appears below.
Comment: One commenter expressed
concern regarding the recent evolution
of SNF care, stating that, in the
commenter’s opinion, while resident
acuity is increasing, facilities worry
more about money than about actual
resident care. The commenter further
stated that fewer staff hours should be
focused on determining a resident’s
particular Resource Utilization Group
(RUG) level for the purpose of managing
facility budgets, and instead should be
focused on resident care. Additionally,
the commenter asked that we establish
standards of practice to eliminate
unwarranted variability in care, such as
residents sharing various health
characteristics but receiving very
different amounts of care.
Response: We appreciate the
commenter raising these points and are
mindful of the commenter’s concern
regarding the apparent tension between
profit and resident care. We also agree
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that SNF care appropriately should
focus on the resident’s unique
characteristics and goals, and note that
RUG determinations should be based on
the type and amount of nursing and
therapy care required by the resident,
rather than on facility budget
considerations. We will consider the
concerns the commenter raised as we
identify future areas for analysis and
program monitoring.
Comment: One commenter
recommended that we address the need
for CMS to broaden the categories of
healthcare professionals who may order
patient diets. The commenter stated that
such a change would improve patient
health and allow SNFs to respond more
quickly to resident nutritional needs.
Response: We appreciate this
comment, but would note as we did in
the FY 2015 SNF PPS final rule (79 FR
45630) that the specific issues the
commenter raised about who may
prescribe diets for SNF residents do not
relate to payment policy, but rather to
certification standards for long-term
care facilities more generally. Therefore,
while we once again note that such
comments lie outside of the scope of
this final rule, we will share them with
the relevant CMS staff that works on
survey and certification issues.
Comment: Several commenters made
comments related to potential
refinements or revisions of the existing
SNF PPS. Some commenters expressed
concern regarding compensation for
non-therapy ancillary services, with one
commenter stating specifically that the
SNF PPS emphasizes therapy services
and deemphasizes the care needs for
medically complex residents,
particularly in hospital-based SNFs. A
second commenter stated that the
current RUG system does not
appropriately capture the intensity or
cost of services for residents in certain
non-therapy RUG groups, most notably
those resident living with Alzheimer’s
disease and dementia. Both commenters
urged CMS to revise the SNF PPS to
account for the potentially increased
intensity or cost of services for
medically complex residents, some of
which may result from the provision of
non-therapy ancillary services. One
commenter expressed a ‘‘growing
impatience’’ with CMS’s lack of
progress in implementing a revised SNF
PPS and urged CMS to move forward
with a revised PPS design or provide a
timeline for when such revisions will be
ready given that the flaws with the
current system are already well known.
A different commenter expressed
support for CMS’s current efforts to
revise the SNF PPS, while at the same
time cautioning CMS to proceed
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gradually by considering an approach
that would transition to a revised PPS
design over time.
Response: We appreciate the
commenters raising these points and
share the commenters’ interest in
exploring ways to revise the SNF PPS
that may improve payment policy as
well as promote appropriate resident
care. We believe that our SNF payment
model research (https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/
therapyresearch.html) will help us
establish a strong basis for examining
potential improvements and
refinements to the overall SNF PPS,
most notably given that we recently
expanded the scope of this research to
focus not only on therapy payment but
nursing and non-therapy ancillary
payments as well. With regard to
comments on the overall approach CMS
is taking in developing a revised PPS
design, and specifically, the two
comments that presented contrasting
views on the pace of our progress, we
would agree with the commenter who
urged a certain degree of caution in
moving to a revised SNF PPS. While we
also agree that many of the issues with
the current system are well known at
this point, we believe that arriving at
appropriate solutions to issues of this
complexity will, of necessity, entail an
investment of time and effort that goes
considerably beyond simply identifying
the issues themselves. That said, we do
believe that we should continue to move
as quickly as possible to address the
issues with the existing SNF PPS
design, though without compromising
the overall integrity of our research and
analysis for the sake of time. We also
welcome additional comments and
feedback on this research, which may be
submitted to: SNFTherapyPayments@
cms.hhs.gov.
Comment: One commenter raised a
concern regarding the potential impact
of current Minimum Data Set (MDS) 3.0
assessment rules and policies during
facility audits of completed MDS
assessments. Specifically, the
commenter stated that during an audit
of assessments completed by a given
facility, it might be discovered that
correcting a given error (for example, an
error in the number of therapy minutes
coded on a given assessment) also
means that a Change-of-Therapy (COT)
Other Medicare-Required Assessment
(OMRA) may have been missed during
that timeframe when the original error
occurred. Due to the missed assessment
policy outlined in Chapters 2 and 6 of
the MDS 3.0 manual, this could mean
that the days associated with that
missed assessment could be considered
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provider liable, which could have a
significant financial impact on the
facility. The commenter recommended
that CMS re-evaluate the potentially
punitive impact of not being able to
complete an MDS after the resident’s
Medicare-covered SNF stay has ended.
Response: The consequences
associated with coding errors and the
use of audits to identify these errors are
necessary to ensure that SNFs take
seriously the responsibility of ensuring
that accurate information is coded on
the MDS. While we appreciate that
errors are always possible, we do not
believe that this is sufficient to warrant
a change in policy at this time. We will
continue to consider this issue as part
of our ongoing evaluation of potential
refinements and improvements to the
overall SNF PPS.
B. SNF PPS Rate Setting Methodology
and FY 2016 Update
1. 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 have been 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 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
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of this adjustment to the forthcoming
annual update of the SNF PPS payment
rates.
costs by a wage index to reflect
geographic variations in wages.
2. SNF Market Basket Update
a. 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. We use the
SNF market basket index, adjusted in
the manner described below, to update
the federal rates on an annual basis. In
the SNF PPS final rule for FY 2014 (78
FR 47939 through 47946), we revised
and rebased the market basket, which
included updating the base year from
FY 2004 to FY 2010.
For the FY 2016 proposed rule, the FY
2010-based SNF market basket growth
rate was estimated to be 2.6 percent,
which was based on the IHS Global
Insight, Inc. (IGI) first quarter 2015
forecast with historical data through
fourth quarter 2014. However, as
discussed in the FY 2016 SNF PPS
proposed rule (80 FR 22049), we
proposed that if more recent data
become available (for example, a more
recent estimate of the FY 2010-based
SNF market basket and/or MFP
adjustment), we would use such data, if
appropriate, to determine the FY 2016
SNF market basket percentage change,
labor-related share relative importance,
forecast error adjustment, and MFP
adjustment in this final rule. Since that
time we have received an updated FY
2016 market basket percentage increase,
which is based on the second quarter
2015 IHS Global Insight forecast of the
FY 2010-based SNF market basket. The
revised market basket growth rate is 2.3
percent. In section III.B.2.e. of this final
rule, we discuss the specific application
b. 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 final rule,
we use the percentage change in the
SNF market basket index to compute the
update factor for FY 2016. This is based
on the IGI second quarter 2015 forecast
(with historical data through the first
quarter 2015) of the FY 2016 percentage
increase in the FY 2010-based SNF
market basket index for routine,
ancillary, and capital-related expenses,
which is used to compute the update
factor in this final rule. As discussed in
sections III.B.2.c. and III.B.2.d. of this
final rule, this market basket percentage
change is reduced by the applicable
forecast error correction (as described in
§ 413.337(d)(2)) and by the multifactor
productivity adjustment as required by
section 1888(e)(5)(B)(ii) of the Act.
Finally, as discussed in section II.B. of
this final rule, we no longer compute
update factors to adjust a facilityspecific 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.
c. 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), the regulations at
§ 413.337(d)(2) provide 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 2014 (the most recently
available FY for which there is final
data), the estimated increase in the
market basket index was 2.3 percentage
points, while the actual increase for FY
2014 was 1.7 percentage points,
resulting in the actual increase being 0.6
percentage point lower than the
estimated increase. Accordingly, as the
difference between the estimated and
actual amount of change in the market
basket index exceeds the 0.5 percentage
point threshold and because, in this
instance, the estimated amount of
change exceeded the actual amount of
change, the FY 2016 market basket
percentage change of 2.3 percent would
be adjusted downward by the forecast
error correction of 0.6 percentage point,
resulting in a SNF market basket
increase of 1.7 percent, before
application of the productivity
adjustment discussed in this section.
Table 1 shows the forecasted and actual
market basket amounts for FY 2014.
TABLE 1—DIFFERENCE BETWEEN THE FORECASTED AND ACTUAL MARKET BASKET INCREASES FOR FY 2014
Index
Forecasted FY
2014 increase *
Actual FY
2014 increase **
FY 2014
Difference
SNF ..............................................................................................................................................
2.3
1.7
¥0.6
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* Published in Federal Register; based on second quarter 2013 IGI forecast (2010-based index).
** Based on the first quarter 2015 IGI forecast, with historical data through the fourth quarter 2014 (2010-based index).
A discussion of the general comments
that we received on the forecast error
adjustment, and our responses to those
comments, appears below.
Comment: One commenter requested
that in determining the need for a
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market basket forecast error adjustment
in a given year, CMS consider
recalculating the wage index budget
neutrality factor (discussed in section
III.B.4 of this final rule) based on more
recent data and utilize any error found
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in the original budget neutrality factor
calculation in CMS’s determination of
the need for a market basket forecast
error adjustment.
Response: The commenter appears to
be requesting a wage index budget
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neutrality factor error adjustment.
However, we note at the outset that
given the limited year-to-year variance
in the wage index budget neutrality
factor, any calculation of a budget
neutrality factor error would likely
represent an error of no more than a few
thousandths of a percentage point, and
thus we do not believe a wage index
budget neutrality factor error adjustment
would be necessary. Moreover, the
market basket forecast error adjustment
and the wage index budget neutrality
factor serve fundamentally different
purposes and involve entirely separate
aspects of the SNF PPS. As such, we do
not believe it would be appropriate to
apply a wage index budget neutrality
factor error to a market basket forecast
error in order to determine if the market
basket forecast error adjustment should
be made.
Comment: One commenter stated that
the forecast error adjustment of 0.6
percentage point represents a significant
reduction and recommended that we
implement the forecast error correction
over a 2-year period.
Response: The forecast error
adjustment is an essential aspect of
ensuring that SNF PPS payments are as
accurate as possible. Therefore,
consistent with the way we have
applied forecast error adjustments in the
past, we do not believe that it is either
appropriate or beneficial to the overall
integrity of the SNF PPS to implement
this adjustment over a multiple-year
period.
tkelley on DSK3SPTVN1PROD with RULES2
d. Multifactor Productivity Adjustment
Section 3401(b) of the Affordable Care
Act 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 productivity
adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act. Section
1886(b)(3)(B)(xi)(II) of the Act, added by
section 3401(a) of the Affordable Care
Act, sets forth the definition of this
productivity adjustment. The statute
defines the productivity 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, costreporting period, or other annual
period) (the MFP adjustment). The
Bureau of Labor Statistics (BLS) is the
agency that publishes the official
measure of private nonfarm business
multifactor productivity (MFP). We refer
readers to the BLS Web site at https://
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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. In section
III.F.3. of the FY 2012 SNF PPS final
rule (76 FR 48527 through 48529), we
identified each of the major MFP
component series employed by the BLS
to measure MFP as well as provided the
corresponding concepts determined to
be the best available proxies for the BLS
series.
Beginning with the FY 2016
rulemaking cycle, the MFP adjustment
is calculated using a revised series
developed by IGI to proxy the aggregate
capital inputs. Specifically, IGI has
replaced the Real Effective Capital Stock
used for Full Employment GDP with a
forecast of BLS aggregate capital inputs
recently developed by IGI using a
regression model. This series provides a
better fit to the BLS capital inputs as
measured by the differences between
the actual BLS capital input growth
rates and the estimated model growth
rates over the historical time period.
Therefore, we are using IGI’s most
recent forecast of the BLS capital inputs
series in the MFP calculations beginning
with the FY 2016 rulemaking cycle. A
complete description of the MFP
projection methodology is available on
our Web site at https://www.cms.gov/
Research-Statistics-Data-and-Systems/
Statistics-Trends-and-Reports/
MedicareProgramRatesStats/
MarketBasketResearch.html. Although
we discuss the IGI changes to the MFP
proxy series in this final rule, in the
future, when IGI makes changes to the
MFP methodology, we will announce
them on our Web site rather than in the
annual rulemaking.
(1) Incorporating the Multifactor
Productivity Adjustment Into the
Market Basket Update
According to 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
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46395
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) (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 for a FY being less
than such payment rates for the
preceding FY. 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.
For the FY 2016 update, the MFP
adjustment is calculated as the 10-year
moving average of changes in MFP for
the period ending September 30, 2016.
In the FY 2016 SNF PPS proposed rule,
this adjustment was calculated to be 0.6
percent. However, as discussed in the
FY 2016 SNF PPS proposed rule (80 FR
22049), we proposed that if more recent
data become available (for example, a
more recent estimate of the FY 2010based SNF market basket and/or MFP
adjustment), we would use such data, if
appropriate, to determine, among other
things, the FY 2016 SNF market basket
percentage change and the MFP
adjustment in this final rule. Therefore,
based on IGI’s most recent second
quarter 2015 forecast (with historical
data through first quarter 2015), the
MFP adjustment for FY 2016 is 0.5
percent. Consistent with section
1888(e)(5)(B)(i) of the Act and
§ 413.337(d)(2) of the regulations, the
market basket percentage for FY 2016
for the SNF PPS is based on IGI’s second
quarter 2015 forecast of the SNF market
basket update (2.3 percent) as adjusted
by the forecast error adjustment (0.6
percentage point), and is estimated to be
1.7 percent. In accordance with section
1888(e)(5)(B)(ii) of the Act (as added by
section 3401(b) of the Affordable Care
Act) and § 413.337(d)(3), this market
basket percentage is then reduced by the
MFP adjustment (the 10-year moving
average of changes in MFP for the
period ending September 30, 2016) of
0.5 percent, which is calculated as
described above and based on IGI’s
second quarter 2015 forecast. The
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tkelley on DSK3SPTVN1PROD with RULES2
resulting MFP-adjusted SNF market
basket update is equal to 1.2 percent, or
1.7 percent less 0.5 percentage point.
e. Market Basket Update Factor for FY
2016
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
2016 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, 2014 through
September 30, 2015 to the average
market basket level for the period of
October 1, 2015 through September 30,
2016. This process yields a percentage
change in the market basket of 2.3
percent.
As further explained in section
III.B.2.c. of this final 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 forecasted FY 2014
SNF market basket percentage change
exceeded the actual FY 2014 SNF
market basket percentage change (FY
2014 is the most recently available FY
for which there is final data) by more
than 0.5 percentage point, the FY 2016
market basket percentage change of 2.3
percent would be adjusted downward
by the applicable difference, which for
FY 2014 is 0.6 percent.
In addition, for FY 2016, section
1888(e)(5)(B)(ii) of the Act requires us to
reduce the market basket percentage
change by the MFP adjustment (the 10year moving average of changes in MFP
for the period ending September 30,
2016) of 0.5 percent, as described in
section III.B.2.d. of this final rule. The
resulting net SNF market basket update
would equal 1.2 percent, or 2.3 percent
less the 0.6 percentage point forecast
error adjustment, less the 0.5 percentage
point MFP adjustment. We proposed in
the FY 2016 SNF PPS proposed rule (80
FR 22049) that if more recent data
become available (for example, a more
recent estimate of the FY 2010-based
SNF market basket and/or MFP
adjustment), we would use such data, if
appropriate, to determine the FY 2016
SNF market basket percentage change,
labor-related share relative importance,
forecast error adjustment, and MFP
adjustment in this final rule. As noted
above, more recent data were used to
update the market basket update and
MFP adjustment in this final rule.
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A discussion of the general comments
that we received on the market basket
update factor for FY 2016, and our
responses to those comments, appears
below.
Comment: We received a number of
comments in relation to applying the FY
2016 market basket update factor in the
determination of the FY 2016
unadjusted federal per diem rates, with
some commenters supporting its
application in determining the FY 2016
unadjusted per diem rates, while others
opposed its application. In their March
2015 report (available at: https://
www.medpac.gov/documents/reports/
chapter-8-skilled-nursing-facilityservices-(march-2015report).pdf?sfvrsn=0) and in their
comment on the FY 2016 SNF PPS
proposed rule, MedPAC recommended
that CMS eliminate the market basket
update for SNFs altogether and rebase
payments for the SNF PPS, beginning
with a 4 percent reduction in the base
payment rates.
Response: We appreciate all of the
comments received on the proposed
market basket update for FY 2016. In
response to those comments which
opposed our applying the FY 2016
market basket update factor in
determining the FY 2016 unadjusted
federal per diem rates, specifically
MedPAC’s proposal to eliminate the
market basket update for SNFs and to
implement a 4 percent reduction to the
SNF PPS base rates, we would need
statutory authority to act on these
proposals at the current time.
Comment: One commenter stated that
in their preliminary analyses, they
observed a gap between the market
basket and costs indexed to 2001 dollars
(which we assume to mean an index
based on 2001 dollars) which occurs
even in rebasing years. They also
observed a growing gap in non-labor
components. They stated that further
research is needed to understand the
gap and they respectfully request that
CMS engage in an ongoing dialogue.
Response: We appreciate the
commenter’s review of the SNF market
basket methodology and look forward to
the commenter’s analysis. While any
comments on the SNF market basket
methodology, including any analyses,
can be emailed to DNHS@cms.hhs.gov,
we would be happy to engage in further
dialogue on this issue.
Comment: One commenter noted that
the weights used in calculating the
market basket update should continue
to use the most updated cost data
available. They suggested that the
market basket be revised and reweighted
with greater frequency—on the same
schedule as the hospital market basket,
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particularly given the new Medicare
provisions, such as the IMPACT Act and
also if the SNF wage index continues to
be directly linked to the hospital wage
index. The commenter also suggested
that CMS update the market basket each
year; alternatively, should such a
process be too onerous, CMS should
calculate the six major cost weights
derived from the Medicare cost report
(wages and salaries, employee benefits,
contract labor, pharmaceuticals,
professional liability insurance and
capital-related) every year and update
the market basket every 4 years (rather
than every 6), as well as whenever the
aggregate percentage change of the six
major cost weights, when taken
together, exceeds some set amount.
Response: We appreciate the
commenter’s request for the SNF market
basket to be revised and reweighted
more frequently. As discussed in the FY
2006 IPPS final rule (70 FR 47387), we
established a rebasing frequency of
every 4 years for the hospital market
basket, in accordance with section 404
of Public Law 108–173. We typically
rebase and revise the SNF market
baskets approximately every 6 years.
Our prior analysis has shown that the
major cost weights do not vary that
much from year to year. However, we do
understand the commenter’s concern for
more frequent rebasings given that any
changes in the Medicare law could alter
the way in which SNFs provide
Medicare services—which, in turn,
potentially could affect the SNF cost
structures (that is, the market basket
cost weights). Accordingly, we will
consider the methodology presented by
the commenter and evaluate the
possible impact on the SNF market
basket update by monitoring the percent
change of the six major cost weights
derived from the Medicare cost report
(wages and salaries, employee benefits,
contract labor, pharmaceuticals,
professional liability insurance and
capital-related).
Accordingly, for the reasons specified
in this final rule and in the FY 2016
SNF PPS proposed rule (80 FR 22047
through 22049), we are applying the FY
2016 market basket increase factor, as
adjusted by the forecast error correction
and MFP adjustment as described
above, in our determination of the FY
2016 SNF PPS unadjusted federal per
diem rates. We used the SNF market
basket, adjusted as described in this
section, to adjust each per diem
component of the federal rates forward
to reflect the change in the average
prices for FY 2016 from average prices
for FY 2015. We would further adjust
the rates by a wage index budget
neutrality factor, described later in this
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section. Tables 2 and 3 reflect the
updated components of the unadjusted
46397
federal rates for FY 2016, prior to
adjustment for case-mix.
TABLE 2—FY 2016 UNADJUSTED FEDERAL RATE PER DIEM URBAN
Rate component
Nursing—
case-mix
Therapy—
case-mix
Therapy—noncase-mix
Non-case-mix
Per Diem Amount ............................................................................................
$171.17
$128.94
$16.98
$87.36
TABLE 3—FY 2016 UNADJUSTED FEDERAL RATE PER DIEM RURAL
Rate component
Nursing—
case-mix
Therapy—
case-mix
Therapy—noncase-mix
Non-case-mix
Per Diem Amount ............................................................................................
$163.53
$148.67
$18.14
$88.97
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3. 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 interim final rule with comment
period that initially implemented the
SNF PPS (63 FR 26252, May 12, 1998),
we developed the RUG–III case-mix
classification system, which tied the
amount of payment to resident resource
use in combination with resident
characteristic information. Staff time
measurement (STM) studies conducted
in 1990, 1995, and 1997 provided
information on resource use (time spent
by staff members on residents) and
resident characteristics that enabled us
not only to establish RUG–III, but also
to create case-mix indexes (CMIs). The
original RUG–III grouper logic was
based on clinical data collected in 1990,
1995, and 1997. As discussed in the
SNF PPS proposed rule for FY 2010 (74
FR 22208), we subsequently conducted
a multi-year data collection and analysis
under the Staff Time and Resource
Intensity Verification (STRIVE) project
to update the case-mix classification
system for FY 2011. The resulting
Resource Utilization Groups, Version 4
(RUG–IV) case-mix classification system
reflected the data collected in 2006
through 2007 during the STRIVE
project, and was finalized in the FY
2010 SNF PPS final rule (74 FR 40288)
to take effect in FY 2011 concurrently
with an updated new resident
assessment instrument, version 3.0 of
the Minimum Data Set (MDS 3.0),
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which collects the clinical data used for
case-mix classification under RUG–IV.
We note that case-mix classification is
based, in part, on the beneficiary’s need
for skilled nursing care and therapy
services. The case-mix classification
system uses clinical data from the MDS
to assign a case-mix group to each
patient that is then used to calculate a
per diem payment under the SNF PPS.
As discussed in section III.C.1. of this
final 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 time
frames 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 Web site
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
MDS30RAIManual.html.
In addition, we note that section 511
of the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA, Pub. L. 108–173) amended
section 1888(e)(12) of the Act to provide
for a temporary increase of 128 percent
in the PPS per diem payment for any
SNF residents with Acquired Immune
Deficiency Syndrome (AIDS), effective
with services furnished on or after
October 1, 2004. This special add-on for
SNF residents with AIDS was to remain
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in effect until the Secretary certifies that
there is an appropriate adjustment in
the case mix to compensate for the
increased costs associated with such
residents. The add-on for SNF residents
with AIDS is also discussed in Program
Transmittal #160 (Change Request
#3291), issued on April 30, 2004, which
is available online at www.cms.gov/
transmittals/downloads/r160cp.pdf. In
the SNF PPS final rule for FY 2010 (74
FR 40288), we did not address the
certification related to the add-on for
SNF residents with AIDS in that final
rule’s implementation of the case-mix
refinements for RUG–IV, thus allowing
the add-on payment required by section
511 of the MMA to remain in effect. For
the limited number of SNF residents
that qualify for this add-on, there is a
significant increase in payments. For
example, using FY 2013 data, we
identified fewer than 4,800 SNF
residents with a diagnosis code of 042
(Human Immunodeficiency Virus (HIV)
Infection). For FY 2016, an urban
facility with a resident with AIDS in
RUG–IV group ‘‘HC2’’ would have a
case-mix adjusted per diem payment of
$427.85 (see Table 4) before the
application of the MMA adjustment.
After an increase of 128 percent, this
urban facility would receive a case-mix
adjusted per diem payment of
approximately $975.50.
Currently, we use the International
Classification of Diseases, 9th revision,
Clinical Modification (ICD–9–CM) code
042 to identify those residents for whom
it is appropriate to apply the AIDS addon established by section 511 of the
MMA. In this context, we note that the
Department published a final rule in the
September 5, 2012 Federal Register (77
FR 54664) which requires us to stop
using ICD–9–CM on September 30,
2014, and begin using the International
Classification of Diseases, 10th revision,
Clinical Modification (ICD–10–CM), on
October 1, 2014. Regarding the abovereferenced ICD–9–CM diagnosis code of
E:\FR\FM\04AUR2.SGM
04AUR2
46398
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
042, in the FY 2014 SNF PPS proposed
rule (78 FR 26444, May 6, 2013), we
proposed to transition to the equivalent
ICD–10–CM diagnosis code of B20 upon
the overall conversion to ICD–10–CM on
October 1, 2014, and we subsequently
finalized that proposal in the FY 2014
SNF PPS final rule (78 FR 47951
through 47952).
However, on April 1, 2014, PAMA
was enacted. Section 212 of PAMA,
titled ‘‘Delay in Transition from ICD–9
to ICD–10 Code Sets,’’ provides that the
Secretary of Health and Human Services
may not, prior to October 1, 2015, adopt
ICD–10 code sets as the standard for
code sets under section 1173(c) of the
Act (42 U.S.C. 1320d–2(c)) and 45 CFR
162.1002. In the FY 2015 SNF PPS final
rule (79 FR 45633), we stated that the
Department expected to release an
interim final rule in the near future that
would include a new compliance date
that would require the use of ICD–10
beginning October 1, 2015. In light of
this, in the FY 2015 SNF PPS final rule,
we stated that the effective date of the
change from ICD–9–CM code 042 to
ICD–10–CM code B20 for purposes of
applying the AIDS add-on is October 1,
2015, and that until that time we would
continue to use the ICD–9–CM code 042
for this purpose. On August 4, 2014,
HHS released a final rule in the Federal
Register (79 FR 45128 through 45134)
that included a new compliance date
that requires the use of ICD–10
beginning October 1, 2015. The August
4, 2014 final rule is available for
viewing on the Internet at https://
www.gpo.gov/fdsys/pkg/FR–2014–08–
04/pdf/2014–18347.pdf. That final rule
also requires HIPAA covered entities to
continue to use ICD–9–CM through
September 30, 2015. Thus, as we
finalized in the FY 2015 SNF PPS final
rule, the effective date of the change
from ICD–9–CM code 042 to ICD–10–
CM code B20 for the purpose of
applying the AIDS add-on enacted by
section 511 of the MMA is October 1,
2015.
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 payment rates set
forth in this final rule reflect the use of
the RUG–IV case-mix classification
system from October 1, 2015, through
September 30, 2016. We list the
proposed case-mix adjusted RUG–IV
payment rates, provided separately for
urban and rural SNFs, in Tables 4 and
5 with corresponding case-mix values.
We use the revised OMB delineations
adopted in the FY 2015 SNF PPS final
rule (79 FR 45632, 45634) to identify a
facility’s urban or rural status for the
purpose of determining which set of rate
tables apply to the facility. These tables
do not reflect the add-on for SNF
residents with AIDS enacted by section
511 of the MMA, which we apply only
after making all other adjustments (such
as wage index and case-mix).
TABLE 4—RUG–IV CASE-MIX ADJUSTED FEDERAL RATES AND ASSOCIATED INDEXES URBAN
tkelley on DSK3SPTVN1PROD with RULES2
RUG–IV
Category
Nursing
index
RUX ..........................
RUL ..........................
RVX ..........................
RVL ..........................
RHX ..........................
RHL ..........................
RMX .........................
RML ..........................
RLX ..........................
RUC .........................
RUB ..........................
RUA ..........................
RVC ..........................
RVB ..........................
RVA ..........................
RHC .........................
RHB ..........................
RHA ..........................
RMC .........................
RMB .........................
RMA .........................
RLB ..........................
RLA ..........................
ES3 ..........................
ES2 ..........................
ES1 ..........................
HE2 ..........................
HE1 ..........................
HD2 ..........................
HD1 ..........................
HC2 ..........................
HC1 ..........................
HB2 ..........................
HB1 ..........................
LE2 ...........................
LE1 ...........................
LD2 ...........................
LD1 ...........................
LC2 ...........................
LC1 ...........................
LB2 ...........................
LB1 ...........................
VerDate Sep<11>2014
19:21 Aug 03, 2015
2.67
2.57
2.61
2.19
2.55
2.15
2.47
2.19
2.26
1.56
1.56
0.99
1.51
1.11
1.10
1.45
1.19
0.91
1.36
1.22
0.84
1.50
0.71
3.58
2.67
2.32
2.22
1.74
2.04
1.60
1.89
1.48
1.86
1.46
1.96
1.54
1.86
1.46
1.56
1.22
1.45
1.14
Therapy
index
Nursing
component
1.87
1.87
1.28
1.28
0.85
0.85
0.55
0.55
0.28
1.87
1.87
1.87
1.28
1.28
1.28
0.85
0.85
0.85
0.55
0.55
0.55
0.28
0.28
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
Jkt 235001
PO 00000
Frm 00010
$457.02
439.91
446.75
374.86
436.48
368.02
422.79
374.86
386.84
267.03
267.03
169.46
258.47
190.00
188.29
248.20
203.69
155.76
232.79
208.83
143.78
256.76
121.53
612.79
457.02
397.11
380.00
297.84
349.19
273.87
323.51
253.33
318.38
249.91
335.49
263.60
318.38
249.91
267.03
208.83
248.20
195.13
Fmt 4701
Therapy
component
Non-case mix
therapy comp
$241.12
241.12
165.04
165.04
109.60
109.60
70.92
70.92
36.10
241.12
241.12
241.12
165.04
165.04
165.04
109.60
109.60
109.60
70.92
70.92
70.92
36.10
36.10
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
Sfmt 4700
E:\FR\FM\04AUR2.SGM
04AUR2
Non-case mix
component
$87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
Total rate
$785.50
768.39
699.15
627.26
633.44
564.98
581.07
533.14
510.30
595.51
595.51
497.94
510.87
442.40
440.69
445.16
400.65
352.72
391.07
367.11
302.06
380.22
244.99
717.13
561.36
501.45
484.34
402.18
453.53
378.21
427.85
357.67
422.72
354.25
439.83
367.94
422.72
354.25
371.37
313.17
352.54
299.47
46399
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
TABLE 4—RUG–IV CASE-MIX ADJUSTED FEDERAL RATES AND ASSOCIATED INDEXES URBAN—Continued
RUG–IV
Category
CE2
CE1
CD2
CD1
CC2
CC1
CB2
CB1
CA2
CA1
BB2
BB1
BA2
BA1
PE2
PE1
PD2
PD1
PC2
PC1
PB2
PB1
PA2
PA1
Nursing
index
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
1.68
1.50
1.56
1.38
1.29
1.15
1.15
1.02
0.88
0.78
0.97
0.90
0.70
0.64
1.50
1.40
1.38
1.28
1.10
1.02
0.84
0.78
0.59
0.54
Therapy
index
Nursing
component
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
287.57
256.76
267.03
236.21
220.81
196.85
196.85
174.59
150.63
133.51
166.03
154.05
119.82
109.55
256.76
239.64
236.21
219.10
188.29
174.59
143.78
133.51
100.99
92.43
Therapy
component
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
Non-case mix
therapy comp
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
16.98
Non-case mix
component
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
87.36
Total rate
391.91
361.10
371.37
340.55
325.15
301.19
301.19
278.93
254.97
237.85
270.37
258.39
224.16
213.89
361.10
343.98
340.55
323.44
292.63
278.93
248.12
237.85
205.33
196.77
TABLE 5—RUG–IV CASE-MIX ADJUSTED FEDERAL RATES AND ASSOCIATED INDEXES RURAL
tkelley on DSK3SPTVN1PROD with RULES2
RUG–IV
Category
Nursing
index
RUX ..........................
RUL ..........................
RVX ..........................
RVL ..........................
RHX ..........................
RHL ..........................
RMX .........................
RML ..........................
RLX ..........................
RUC .........................
RUB ..........................
RUA ..........................
RVC ..........................
RVB ..........................
RVA ..........................
RHC .........................
RHB ..........................
RHA ..........................
RMC .........................
RMB .........................
RMA .........................
RLB ..........................
RLA ..........................
ES3 ..........................
ES2 ..........................
ES1 ..........................
HE2 ..........................
HE1 ..........................
HD2 ..........................
HD1 ..........................
HC2 ..........................
HC1 ..........................
HB2 ..........................
HB1 ..........................
LE2 ...........................
LE1 ...........................
LD2 ...........................
LD1 ...........................
LC2 ...........................
LC1 ...........................
VerDate Sep<11>2014
19:21 Aug 03, 2015
2.67
2.57
2.61
2.19
2.55
2.15
2.47
2.19
2.26
1.56
1.56
0.99
1.51
1.11
1.10
1.45
1.19
0.91
1.36
1.22
0.84
1.50
0.71
3.58
2.67
2.32
2.22
1.74
2.04
1.60
1.89
1.48
1.86
1.46
1.96
1.54
1.86
1.46
1.56
1.22
Therapy
index
Nursing
component
1.87
1.87
1.28
1.28
0.85
0.85
0.55
0.55
0.28
1.87
1.87
1.87
1.28
1.28
1.28
0.85
0.85
0.85
0.55
0.55
0.55
0.28
0.28
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
Jkt 235001
PO 00000
Frm 00011
$436.63
420.27
426.81
358.13
417.00
351.59
403.92
358.13
369.58
255.11
255.11
161.89
246.93
181.52
179.88
237.12
194.60
148.81
222.40
199.51
137.37
245.30
116.11
585.44
436.63
379.39
363.04
284.54
333.60
261.65
309.07
242.02
304.17
238.75
320.52
251.84
304.17
238.75
255.11
199.51
Fmt 4701
Therapy
component
Non-case mix
therapy comp
$278.01
278.01
190.30
190.30
126.37
126.37
81.77
81.77
41.63
278.01
278.01
278.01
190.30
190.30
190.30
126.37
126.37
126.37
81.77
81.77
81.77
41.63
41.63
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
Sfmt 4700
E:\FR\FM\04AUR2.SGM
04AUR2
Non-case mix
component
$88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
Total rate
$803.61
787.25
706.08
637.40
632.34
566.93
574.66
528.87
500.18
622.09
622.09
528.87
526.20
460.79
459.15
452.46
409.94
364.15
393.14
370.25
308.11
375.90
246.71
692.55
543.74
486.50
470.15
391.65
440.71
368.76
416.18
349.13
411.28
345.86
427.63
358.95
411.28
345.86
362.22
306.62
46400
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
TABLE 5—RUG–IV CASE-MIX ADJUSTED FEDERAL RATES AND ASSOCIATED INDEXES RURAL—Continued
RUG–IV
Category
Nursing
index
LB2 ...........................
LB1 ...........................
CE2 ..........................
CE1 ..........................
CD2 ..........................
CD1 ..........................
CC2 ..........................
CC1 ..........................
CB2 ..........................
CB1 ..........................
CA2 ..........................
CA1 ..........................
BB2 ..........................
BB1 ..........................
BA2 ..........................
BA1 ..........................
PE2 ..........................
PE1 ..........................
PD2 ..........................
PD1 ..........................
PC2 ..........................
PC1 ..........................
PB2 ..........................
PB1 ..........................
PA2 ..........................
PA1 ..........................
1.45
1.14
1.68
1.50
1.56
1.38
1.29
1.15
1.15
1.02
0.88
0.78
0.97
0.90
0.70
0.64
1.50
1.40
1.38
1.28
1.10
1.02
0.84
0.78
0.59
0.54
Therapy
index
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
tkelley on DSK3SPTVN1PROD with RULES2
4. 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 proposed to continue this
practice for FY 2016, 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. For
FY 2016, the updated wage data are for
hospital cost reporting periods
beginning on or after October 1, 2011
and before October 1, 2012 (FY 2012
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)
VerDate Sep<11>2014
19:21 Aug 03, 2015
Nursing
component
Jkt 235001
237.12
186.42
274.73
245.30
255.11
225.67
210.95
188.06
188.06
166.80
143.91
127.55
158.62
147.18
114.47
104.66
245.30
228.94
225.67
209.32
179.88
166.80
137.37
127.55
96.48
88.31
Therapy
component
Non-case mix
therapy comp
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
authorized us to establish a geographic
reclassification procedure that is
specific to SNFs, but only after
collecting the data necessary to establish
a SNF 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.
In addition, we proposed 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 FY 2016 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 2016, there are
no rural geographic areas that do not
have hospitals, and thus, this
methodology will not be applied. For
rural Puerto Rico, we will 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
PO 00000
Frm 00012
Fmt 4701
Sfmt 4700
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
18.14
Non-case mix
component
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
88.97
Total rate
344.23
293.53
381.84
352.41
362.22
332.78
318.06
295.17
295.17
273.91
251.02
234.66
265.73
254.29
221.58
211.77
352.41
336.05
332.78
316.43
286.99
273.91
244.48
234.66
203.59
195.42
is higher than that in half of its urban
areas); instead, we will continue to use
the most recent wage index previously
available for that area. For urban areas
without specific hospital wage index
data, we will 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 2016, the only urban area
without wage index data available is
CBSA 25980, Hinesville-Fort Stewart,
GA. The wage index applicable to FY
2016 is set forth in Table A available on
the CMS Web site at https://cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/WageIndex.html.
Once calculated, we will 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
2014 (78 FR 47944 through 47946), we
finalized a proposal to revise the laborrelated share to reflect the relative
importance of the revised FY 2010based SNF market basket cost weights
for the following cost categories: Wages
and salaries; employee benefits; the
labor-related portion of nonmedical
professional fees; administrative and
facilities support services; all other:
E:\FR\FM\04AUR2.SGM
04AUR2
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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
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 2016. 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 2016 than the base
year weights from the SNF market
basket.
We calculate the labor-related relative
importance for FY 2016 in four steps.
First, we compute the FY 2016 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
2016 price index level for that cost
category by the total market basket price
index level. Third, we determine the FY
2016 relative importance for each cost
category by multiplying this ratio by the
base year (FY 2010) weight. Finally, we
add the FY 2016 relative importance for
each of the labor-related cost categories
(wages and salaries, employee benefits,
the labor-related portion of non-medical
professional fees, administrative and
facilities support services, all other:
labor-related services, and a portion of
capital-related expenses) to produce the
FY 2016 labor-related relative
importance. Table 6 summarizes the
updated labor-related share for FY 2016,
compared to the labor-related share that
was used for the FY 2015 SNF PPS final
rule.
We proposed for FY 2016 and
subsequent FYs, to report and apply the
SNF PPS labor-related share at a tenth
of a percentage point (rather than at a
thousandth of a percentage point)
consistent with the manner in which we
report and apply the market basket
update percentage under the SNF PPS
and the IPPS and the manner in which
we report and apply the IPPS laborrelated share. The level of precision
specified for the IPPS labor-related
share is three decimal places or a tenth
of a percentage point (0.696 or 69.6
percent), which we believe provides a
reasonable level of precision. We
believe it is appropriate to maintain
such consistency across all payment
systems so that the level of precision
specified is both reasonable and similar
for all providers. Additionally, we
proposed in the FY 2016 SNF PPS
proposed rule (80 FR 22049) that if more
recent data become available (for
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19:21 Aug 03, 2015
Jkt 235001
example, a more recent estimate of the
FY 2010-based SNF market basket and/
or MFP adjustment), we would use such
data, if appropriate, to determine the FY
2016 SNF market basket percentage
change, labor-related share relative
importance, forecast error adjustment,
and MFP adjustment in this final rule.
We note that more recent data did
become available and that the proposed
labor related share for FY 2016 of 69.2
percent has been updated, based on
IGI’s second quarter 2015 forecast, to an
FY 2016 labor related share of 69.1
percent.
We invited public comments on these
proposals. A discussion of the
comments we received on these
proposals, as well as a discussion of the
general comments that we received on
the wage index adjustment, and our
responses to those comments, appears
below.
Comment: Several commenters stated
that hospital cost data may not be the
most reliable resource when
determining geographical differences in
salary structure for SNFs. These
commenters urged CMS to establish a
SNF-specific wage index. One
commenter stated that new SNF cost
reports, required by section 6104 of the
Affordable Care Act, provide the
requisite data in order for CMS to
establish a SNF-specific wage index that
could replace the current use of the
inpatient hospital wage index data as
the basis for the current SNF wage
index.
Response: We appreciate the
commenters raising these concerns,
particularly the one commenter who
provided significant details on how new
SNF cost-report data could be used to
develop a SNF-specific wage index.
While CMS may consider this new data
source as a potential stepping-stone
towards developing a SNF-specific wage
index, we note that consistent with our
previous responses to these recurring
comments (most recently published in
the FY 2015 SNF PPS final rule (79 FR
45636)), developing such a wage index
would require a resource-intensive audit
process similar to that used for IPPS
hospital data, to improve the quality of
the SNF cost report data in order for it
to be used as part of this analysis.
Ultimately, while we continue to review
all available data and contemplate the
potential methodological approaches for
a SNF-specific wage index in the future,
we do not believe that the current state
of the data is sufficiently refined to
permit any such use of this data at this
time.
Comment: Some commenters urged
that CMS, to the extent that we plan to
continue to use hospital cost data as the
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46401
basis for SNF wage index adjustments,
consider adopting certain wage index
policies in use under the IPPS, such as
reclassification or rural floor, because
SNFs compete in a similar labor pool as
acute care hospitals. Commenters also
stated that CMS should use postreclassification hospital wage data to
influence SNF PPS wage index policy
decisions. These commenters further
stated that in addition to considering
such policies as reclassification and a
rural floor, CMS should consider
implementing a floor and ceiling for
annual changes to the wage index in
order to smooth perceived volatility of
such changes.
Response: Consistent with our
previous responses to these recurring
comments (most recently published in
the FY 2015 SNF PPS final rule (79 FR
45636 through 45637), we continue to
believe that in the absence of the
appropriate SNF-specific wage data,
using the pre-reclassified hospital
inpatient wage data (without the
occupational mix adjustment) is
appropriate and reasonable for the SNF
PPS. As discussed above, section 315 of
BIPA authorized us to establish a
geographic reclassification procedure
that is specific to SNFs, only after
collecting the data necessary to establish
a SNF-specific wage index that is based
on data from nursing homes. However,
to date this has been infeasible 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. Furthermore, we do
not believe that using hospital
reclassification data would be
appropriate as this data is specific to the
requesting hospitals and it may or may
not apply to a given SNF in a given
instance. With regard to implementing a
rural floor, we do not believe it would
be prudent at this time to adopt such a
policy, because MedPAC has
recommended eliminating the rural
floor policy from the calculation of the
IPPS wage index (see, for example,
Chapter 3 of MedPAC’s March 2013
Report to Congress on Medicare
Payment Policy, available at https://
medpac.gov/documents/reports/mar13_
entirereport.pdf, which notes on page
65 that in 2007, MedPAC had ‘‘. . .
recommended eliminating these special
wage index adjustments and adopting a
new wage index system to avoid
geographic inequities that can occur due
to current wage index policies
(Medicare Payment Advisory
Commission 2007b.’’) If we adopted the
rural floor at this time under the SNF
PPS, we believe that, the SNF PPS wage
index could become vulnerable to
E:\FR\FM\04AUR2.SGM
04AUR2
46402
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
problems similar to those that MedPAC
identified in its March 2013 Report to
Congress. Additionally, at this time, we
do not believe it would be appropriate
to establish a floor and ceiling for
annual wage index changes. Any
perceived volatility in the wage index is
predicated upon volatility in actual
wages in that area and reflects real
differences in area wage levels that
should be accounted for timely. As
stated above, under 1888(e)(4)(G)(ii) of
the Act and § 413.337(a)(1)(ii) of the
regulations, we adjust the SNF PPS rates
to account for differences in area wage
levels. We believe that applying a
ceiling or floor to annual wage index
changes would make the wage index for
a given area less reflective of the area
wage levels and changes. Additionally,
we note that establishing an artificial
ceiling for annual changes in the wage
index could not only result in an
inaccurate wage index, but also
potentially have an adverse impact on
those providers that would otherwise
experience a larger increase in their
wage index absent such a ceiling.
Comment: One commenter requested
that CMS provide more detail on the
processes and procedures that are used
in determining what hospital data may
be excluded from forming the inpatient
hospital wage index, which serves as
the basis for the SNF wage index.
Response: The processes and
procedures for how the inpatient
hospital wage index is developed are
discussed in the Inpatient Prospective
Payment System (IPPS) rule each year,
with the most recent discussion
appearing in the FY 2016 IPPS proposed
rule (80 FR 24463 through 24477) and
subsequent FY 2016 IPPS final rule.
After considering the comments
received and for the reasons discussed
above and in the FY 2016 SNF PPS
proposed rule (80 FR 22052 through
22056), we are finalizing the FY 2016
wage index adjustment and related
policies as proposed in the FY 2016
SNF PPS proposed rule without
modification. For FY 2016, the updated
wage data are for hospital cost reporting
periods beginning on or after October 1,
2011 and before October 1, 2012 (FY
2012 cost report data). We are also
finalizing our proposal that for FY 2016
and subsequent FYs, we will report and
apply the SNF PPS labor-related share at
a tenth of a percentage point (rather
than at a thousandth of a percentage
point) consistent with the manner in
which we report and apply the market
basket update percentage under the SNF
PPS and the IPPS and the manner in
which we report and apply the IPPS
labor-related share. Table 6 summarizes
the updated labor-related share for FY
2016, compared to the labor-related
share that was used for the FY 2015 SNF
PPS final rule.
TABLE 6—LABOR-RELATED RELATIVE IMPORTANCE, FY 2015 AND FY 2016
Relative importance,
labor-related,
FY 2015
14:2 forecast 1
Relative importance,
labor-related,
FY 2016
15:2 forecast 2
Wages and salaries .................................................................................................................
Employee benefits ...................................................................................................................
Nonmedical Professional fees: labor-related ...........................................................................
Administrative and facilities support services ..........................................................................
All Other: Labor-related services .............................................................................................
Capital-related (.391) ...............................................................................................................
48.816
11.365
3.450
0.502
2.276
2.771
48.8
11.3
3.5
0.5
2.3
2.7
Total ..................................................................................................................................
69.180
69.1
1 Published
2 Based
in the Federal Register; based on second quarter 2014 IGI forecast
on second quarter 2015 IGI forecast, with historical data through first quarter 2015.
Tables 7 and 8 show the RUG–IV
case-mix adjusted federal rates by labor-
related and non-labor-related
components.
TABLE 7—RUG–IV CASE-MIX ADJUSTED FEDERAL RATES FOR URBAN SNFS BY LABOR AND NON-LABOR COMPONENT
tkelley on DSK3SPTVN1PROD with RULES2
RUG–IV Category
Total rate
RUX ..............................................................
RUL ...............................................................
RVX ...............................................................
RVL ...............................................................
RHX ..............................................................
RHL ...............................................................
RMX ..............................................................
RML ..............................................................
RLX ...............................................................
RUC ..............................................................
RUB ..............................................................
RUA ..............................................................
RVC ..............................................................
RVB ...............................................................
RVA ...............................................................
RHC ..............................................................
RHB ..............................................................
RHA ..............................................................
RMC ..............................................................
RMB ..............................................................
RMA ..............................................................
RLB ...............................................................
VerDate Sep<11>2014
19:21 Aug 03, 2015
Jkt 235001
785.50
768.39
699.15
627.26
633.44
564.98
581.07
533.14
510.30
595.51
595.51
497.94
510.87
442.40
440.69
445.16
400.65
352.72
391.07
367.11
302.06
380.22
PO 00000
Labor portion
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
Frm 00014
Fmt 4701
Sfmt 4700
E:\FR\FM\04AUR2.SGM
$542.78
530.96
483.11
433.44
437.71
390.40
401.52
368.40
352.62
411.50
411.50
344.08
353.01
305.70
304.52
307.61
276.85
243.73
270.23
253.67
208.72
262.73
04AUR2
Non-labor portion
$242.72
237.43
216.04
193.82
195.73
174.58
179.55
164.74
157.68
184.01
184.01
153.86
157.86
136.70
136.17
137.55
123.80
108.99
120.84
113.44
93.34
117.49
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
46403
TABLE 7—RUG–IV CASE-MIX ADJUSTED FEDERAL RATES FOR URBAN SNFS BY LABOR AND NON-LABOR COMPONENT—
Continued
RUG–IV Category
Total rate
RLA ...............................................................
ES3 ...............................................................
ES2 ...............................................................
ES1 ...............................................................
HE2 ...............................................................
HE1 ...............................................................
HD2 ...............................................................
HD1 ...............................................................
HC2 ...............................................................
HC1 ...............................................................
HB2 ...............................................................
HB1 ...............................................................
LE2 ................................................................
LE1 ................................................................
LD2 ...............................................................
LD1 ...............................................................
LC2 ...............................................................
LC1 ...............................................................
LB2 ................................................................
LB1 ................................................................
CE2 ...............................................................
CE1 ...............................................................
CD2 ...............................................................
CD1 ...............................................................
CC2 ...............................................................
CC1 ...............................................................
CB2 ...............................................................
CB1 ...............................................................
CA2 ...............................................................
CA1 ...............................................................
BB2 ...............................................................
BB1 ...............................................................
BA2 ...............................................................
BA1 ...............................................................
PE2 ...............................................................
PE1 ...............................................................
PD2 ...............................................................
PD1 ...............................................................
PC2 ...............................................................
PC1 ...............................................................
PB2 ...............................................................
PB1 ...............................................................
PA2 ...............................................................
PA1 ...............................................................
244.99
717.13
561.36
501.45
484.34
402.18
453.53
378.21
427.85
357.67
422.72
354.25
439.83
367.94
422.72
354.25
371.37
313.17
352.54
299.47
391.91
361.10
371.37
340.55
325.15
301.19
301.19
278.93
254.97
237.85
270.37
258.39
224.16
213.89
361.10
343.98
340.55
323.44
292.63
278.93
248.12
237.85
205.33
196.77
Labor portion
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
169.29
495.54
387.90
346.50
334.68
277.91
313.39
261.34
295.64
247.15
292.10
244.79
303.92
254.25
292.10
244.79
256.62
216.40
243.61
206.93
270.81
249.52
256.62
235.32
224.68
208.12
208.12
192.74
176.18
164.35
186.83
178.55
154.89
147.80
249.52
237.69
235.32
223.50
202.21
192.74
171.45
164.35
141.88
135.97
Non-labor portion
75.70
221.59
173.46
154.95
149.66
124.27
140.14
116.87
132.21
110.52
130.62
109.46
135.91
113.69
130.62
109.46
114.75
96.77
108.93
92.54
121.10
111.58
114.75
105.23
100.47
93.07
93.07
86.19
78.79
73.50
83.54
79.84
69.27
66.09
111.58
106.29
105.23
99.94
90.42
86.19
76.67
73.50
63.45
60.80
TABLE 8—RUG–IV CASE-MIX ADJUSTED FEDERAL RATES FOR RURAL SNFS BY LABOR AND NON-LABOR COMPONENT
tkelley on DSK3SPTVN1PROD with RULES2
RUG–IV category
Total rate
RUX ..............................................................
RUL ...............................................................
RVX ...............................................................
RVL ...............................................................
RHX ..............................................................
RHL ...............................................................
RMX ..............................................................
RML ..............................................................
RLX ...............................................................
RUC ..............................................................
RUB ..............................................................
RUA ..............................................................
RVC ..............................................................
RVB ...............................................................
RVA ...............................................................
RHC ..............................................................
RHB ..............................................................
RHA ..............................................................
RMC ..............................................................
RMB ..............................................................
RMA ..............................................................
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Jkt 235001
803.61
787.25
706.08
637.40
632.34
566.93
574.66
528.87
500.18
622.09
622.09
528.87
526.20
460.79
459.15
452.46
409.94
364.15
393.14
370.25
308.11
PO 00000
Labor portion
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
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E:\FR\FM\04AUR2.SGM
$555.29
543.99
487.90
440.44
436.95
391.75
397.09
365.45
345.62
429.86
429.86
365.45
363.60
318.41
317.27
312.65
283.27
251.63
271.66
255.84
212.90
04AUR2
Non-labor portion
$248.32
243.26
218.18
196.96
195.39
175.18
177.57
163.42
154.56
192.23
192.23
163.42
162.60
142.38
141.88
139.81
126.67
112.52
121.48
114.41
95.21
46404
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
TABLE 8—RUG–IV CASE-MIX ADJUSTED FEDERAL RATES FOR RURAL SNFS BY LABOR AND NON-LABOR COMPONENT—
Continued
RUG–IV category
Total rate
tkelley on DSK3SPTVN1PROD with RULES2
RLB ...............................................................
RLA ...............................................................
ES3 ...............................................................
ES2 ...............................................................
ES1 ...............................................................
HE2 ...............................................................
HE1 ...............................................................
HD2 ...............................................................
HD1 ...............................................................
HC2 ...............................................................
HC1 ...............................................................
HB2 ...............................................................
HB1 ...............................................................
LE2 ................................................................
LE1 ................................................................
LD2 ...............................................................
LD1 ...............................................................
LC2 ...............................................................
LC1 ...............................................................
LB2 ................................................................
LB1 ................................................................
CE2 ...............................................................
CE1 ...............................................................
CD2 ...............................................................
CD1 ...............................................................
CC2 ...............................................................
CC1 ...............................................................
CB2 ...............................................................
CB1 ...............................................................
CA2 ...............................................................
CA1 ...............................................................
BB2 ...............................................................
BB1 ...............................................................
BA2 ...............................................................
BA1 ...............................................................
PE2 ...............................................................
PE1 ...............................................................
PD2 ...............................................................
PD1 ...............................................................
PC2 ...............................................................
PC1 ...............................................................
PB2 ...............................................................
PB1 ...............................................................
PA2 ...............................................................
PA1 ...............................................................
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
2016 (federal rates effective October 1,
2015), we will apply an adjustment to
fulfill the budget neutrality requirement.
We 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 2015 to the weighted
average wage adjustment factor for FY
2016. For this calculation, we use the
same FY 2014 claims utilization data for
both the numerator and denominator of
VerDate Sep<11>2014
19:21 Aug 03, 2015
Jkt 235001
375.90
246.71
692.55
543.74
486.50
470.15
391.65
440.71
368.76
416.18
349.13
411.28
345.86
427.63
358.95
411.28
345.86
362.22
306.62
344.23
293.53
381.84
352.41
362.22
332.78
318.06
295.17
295.17
273.91
251.02
234.66
265.73
254.29
221.58
211.77
352.41
336.05
332.78
316.43
286.99
273.91
244.48
234.66
203.59
195.42
Labor portion
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
...........................................................
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 budget neutrality
factor for FY 2016 would be 0.9992.
In the SNF PPS final rule for FY 2006
(70 FR 45026, August 4, 2005), we
adopted the changes discussed in the
OMB Bulletin No. 03–04 (June 6, 2003),
available online at
www.whitehouse.gov/omb/bulletins/
b03-04.html, 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
PO 00000
Frm 00016
Fmt 4701
Sfmt 4700
259.75
170.48
478.55
375.72
336.17
324.87
270.63
304.53
254.81
287.58
241.25
284.19
238.99
295.49
248.03
284.19
238.99
250.29
211.87
237.86
202.83
263.85
243.52
250.29
229.95
219.78
203.96
203.96
189.27
173.45
162.15
183.62
175.71
153.11
146.33
243.52
232.21
229.95
218.65
198.31
189.27
168.94
162.15
140.68
135.04
Non-labor portion
116.15
76.23
214.00
168.02
150.33
145.28
121.02
136.18
113.95
128.60
107.88
127.09
106.87
132.14
110.92
127.09
106.87
111.93
94.75
106.37
90.70
117.99
108.89
111.93
102.83
98.28
91.21
91.21
84.64
77.57
72.51
82.11
78.58
68.47
65.44
108.89
103.84
102.83
97.78
88.68
84.64
75.54
72.51
62.91
60.38
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.
On February 28, 2013, OMB issued
OMB Bulletin No. 13–01, announcing
revisions to the delineation of MSAs,
Micropolitan Statistical Areas, and
Combined Statistical Areas, and
guidance on uses of the delineation of
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these areas. This bulletin, which is
available online at https://
www.whitehouse.gov/sites/default/files/
omb/bulletins/2013/b-13-01.pdf,
provides the delineations of all
Metropolitan Statistical Areas,
Metropolitan Divisions, Micropolitan
Statistical Areas, Combined Statistical
Areas, and New England City and Town
Areas in the United States and Puerto
Rico based on the standards published
on June 28, 2010, in the Federal
Register (75 FR 37246 through 37252)
and Census Bureau data.
While the revisions OMB published
on February 28, 2013 are not as
sweeping as the changes made when we
adopted the CBSA geographic
designations for FY 2006, the February
28, 2013 bulletin does contain a number
of significant changes. For example,
there are new CBSAs, urban counties
that became rural, rural counties that
became urban, and existing CBSAs that
were split apart.
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. Because the 1-year
transition period expires at the end of
FY 2015, the SNF PPS wage index for
FY 2016 is fully based on the revised
OMB delineations adopted in FY 2015.
As noted in this section, the wage index
46405
applicable to FY 2016 is set forth in
Table A available on the CMS Web site
at https://cms.gov/Medicare/MedicareFee-for-Service-Payment/SNFPPS/
WageIndex.html.
5. Adjusted Rate Computation Example
Using the hypothetical SNF XYZ
described below, Table 9 shows the
adjustments made to the federal per
diem rates to compute the provider’s
actual per diem PPS payment. We
derive the Labor and Non-labor columns
from Table 7. The wage index used in
this example is based on the wage index
found in Table A as referenced in this
section. As illustrated in Table 9, SNF
XYZ’s total PPS payment would equal
$45,256.24.
TABLE 9—ADJUSTED RATE COMPUTATION EXAMPLE SNF XYZ: LOCATED IN FREDERICK, MD (URBAN CBSA 43524)
WAGE INDEX: 0.9640
[See wage index in table A] 1
RUG–IV Group
Labor
Wage index
Adjusted labor
Non-labor
Adjusted rate
Percent
adjustment
RVX ...................................
ES2 ....................................
RHA ...................................
CC2 * .................................
BA2 ....................................
$483.11
387.90
243.73
224.68
154.89
........................
0.9640
0.9640
0.9640
0.9640
0.9640
........................
$465.72
373.94
234.96
216.59
149.31
........................
$216.04
173.46
108.99
100.47
69.27
........................
$681.76
547.40
343.95
317.06
218.58
........................
$681.76
547.40
343.95
722.90
218.58
........................
Medicare days
14
30
16
10
30
100
Payment
$9,544.64
16,422.00
5,503.20
7,229.00
6,557.40
45,256.24
* Reflects a 128 percent adjustment from section 511 of the MMA.
1 Available on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
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C. Additional Aspects of the SNF PPS
1. 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 casemix classification system discussed in
section III.B.3 of this final rule. This
approach includes an administrative
presumption that utilizes a beneficiary’s
initial classification in one of the upper
52 RUGs of the 66-group RUG–IV casemix classification system to assist in
making certain SNF level of care
determinations.
In accordance with section
1888(e)(4)(H)(ii) of the Act and the
regulations at § 413.345, we include in
each update of the federal payment rates
in the Federal Register the designation
of those specific RUGs under the
classification system that represent the
required SNF level of care, as provided
in § 409.30. As set forth in the FY 2011
SNF PPS update notice (75 FR 42910),
this designation reflects an
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administrative presumption under the
66-group RUG–IV system that
beneficiaries who are correctly assigned
to one of the upper 52 RUG–IV groups
on the initial 5-day, Medicare-required
assessment are automatically classified
as meeting the SNF level of care
definition up to and including the
assessment reference date on the fiveday Medicare-required assessment.
A beneficiary assigned to any of the
lower 14 RUG–IV groups is not
automatically classified as either
meeting or not meeting the definition,
but instead receives an individual level
of care determination using the existing
administrative criteria. This
presumption recognizes the strong
likelihood that beneficiaries assigned to
one of the upper 52 RUG–IV groups
during the immediate post-hospital
period require a covered level of care,
which would be less likely for those
beneficiaries assigned to one of the
lower 14 RUG–IV groups.
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.
In this final rule, we will continue to
designate the upper 52 RUG–IV groups
for purposes of this administrative
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presumption, consisting of all groups
encompassed by the following RUG–IV
categories:
• Rehabilitation plus Extensive
Services.
• Ultra High Rehabilitation.
• Very High Rehabilitation.
• High Rehabilitation.
• Medium Rehabilitation.
• Low Rehabilitation.
• Extensive Services.
• Special Care High.
• Special Care Low.
• Clinically Complex.
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 the
services prompting the beneficiary’s
assignment to one of the upper 52 RUG–
IV groups (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
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the Act). Accordingly, the presumption
would not apply, for example, in those
situations in which a resident’s assignment to
one of the upper . . . groups is itself based
on 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 assessment
reference date of the 5-day assessment.
We received one comment on this
issue, which we discuss below along
with our response.
Comment: One commenter requested
that CMS consider further analysis of
the administrative presumption that
utilizes a beneficiary’s initial
classification in one of the upper 52
RUGs to assist in making certain SNF
level of care determinations. The
commenter expressed concern that the
use of such presumptions could
disadvantage members of certain
vulnerable specialty populations who
might not typically group to one of the
upper 52 RUGs, and yet still require a
sufficient intensity of services to qualify
for coverage.
Response: While it is true that those
SNF residents who group to one of the
lower 14 RUGs on the initial 5-day,
Medicare-required assessment are not
automatically presumed to require a
skilled level of care, neither are they
automatically classified as requiring
nonskilled care. Instead, as we have
noted in this and previous SNF PPS
rules, any such resident ‘‘. . . receives
an individual level of care
determination using the existing
administrative criteria.’’ We adopted
this approach specifically to ensure that
the presumption does not disadvantage
such residents, by providing them with
an individualized level of care
determination that fully considers all
pertinent factors. Nevertheless, as we
noted previously in the FY 2000 SNF
PPS final rule (64 FR 41668, July 30,
1999), while we believe that the use of
the administrative level of care
presumption ‘‘. . . represents a
significant advancement toward
achieving greater simplicity,
predictability, and consistency in the
coverage process, we will continue to
monitor coverage determinations under
the SNF PPS with a view toward the
possibility of making further
refinements and improvements in the
future.’’ Accordingly, we will keep the
commenter’s concerns in mind as we
continue our ongoing SNF PPS research
and analysis.
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2. Consolidated Billing
Sections 1842(b)(6)(E) and 1862(a)(18)
of the Act (as added by section 4432(b)
of the BBA) require a SNF to submit
consolidated Medicare bills to its
Medicare Administrative Contractor 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
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 Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/Downloads/
Legislative_History_07302013.pdf. In
particular, section 103 of the Medicare,
Medicaid, and SCHIP Balanced Budget
Refinement Act of 1999 (BBRA, Pub. L.
106–113) 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
discussed 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 19231 through 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
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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 prospective payment system.
. . .’’ According to the conferees,
section 103(a) of the BBRA ‘‘is an
attempt to exclude from the PPS certain
services and costly items that are
provided infrequently in SNFs. . . .’’
By contrast, we noted that the Congress
declined to 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
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), and since that time, we have
periodically invited the public to submit
comments identifying codes that might
meet the criteria for exclusion. In the FY
2016 SNF PPS proposed rule (80 FR
22057–58), we specifically invited
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, and we requested
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commenters to 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. A discussion of the
public comments received on this topic,
along with our responses, appears
below.
Comment: One commenter
recommended a new chemotherapy
drug, BLINCYTO®, as meeting the
statutory ‘‘high-cost, low probability’’
criteria for exclusion from consolidated
billing. After noting that this drug
currently is assigned a temporary C
code, C9449 (Injection, blinatumomab,
1 mcg.), the commenter referred to our
explanation in the FY 2015 SNF PPS
final rule that ‘‘. . . a chemotherapy
drug’s assignment to its own specific
code has always served as the
mechanism of designating that drug for
exclusion, as well as the means by
which the claims processing system is
able to recognize that exclusion’’ (79 FR
45642, August 5, 2014). The commenter
then suggested that until such time as
this drug may be assigned a permanent
J code of its own, CMS should devise an
administrative alternative for
effectuating its exclusion from
consolidated billing, such as utilizing
the drug’s existing C code for this
purpose. The commenter further stated
that the exclusion list’s current use of C
codes for designating the excluded
magnetic resonance imaging (MRI)
services in Major Category I.C
establishes the feasibility of similarly
adopting such an approach for
chemotherapy drugs like BLINCYTO®
under Major Category III.A.
Response: We agree with the
commenter that, as described, this drug
would appear to meet the ‘‘high-cost,
low probability’’ criteria to qualify for
the statutory carve-out of certain highly
intensive chemotherapy drugs from
consolidated billing. We note that, as
described in the National Institutes of
Health’s MedlinePlus Web site at
www.nlm.nih.gov/medlineplus/
druginfo/meds/a614061.html, this is
one of the types of drugs referenced in
the BBRA Conference Report’s
legislative history on the chemotherapy
exclusion (H.R. Rep. No. 106–479 at 854
(1999) (Conf. Rep.)); namely, those
chemotherapy drugs that ‘‘. . . are given
as infusions, thus requiring special staff
expertise to administer.’’ In addition,
the comment itself notes that ‘‘In the six
months since BLINCYTO® has been
approved and available on the market,
we are not aware of any patients who
were treated with BLINCYTO® in the
SNF setting’’ (emphasis added).
However, we are unable to adopt the
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commenter’s suggestion that until a
specific J code is assigned, a C code
appropriately could be used on an
interim basis as a vehicle for designating
a chemotherapy drug for exclusion from
consolidated billing. While the
commenter is correct in pointing out
some excluded MRI services that are
identified by C code, we note that these
C codes are designed specifically for use
under the outpatient hospital PPS
(OPPS), and that in contrast to the
administrative exclusion for MRIs—
which is a hospital-specific exclusion—
the statutory chemotherapy exclusion is
a categorical one that applies equally to
hospital and non-hospital settings alike.
This means that a temporary C code
would not be suitable for the purpose of
excluding chemotherapy drugs from
consolidated billing and that, as we
indicated previously in the FY 2015
SNF PPS final rule, we are unable to
designate a chemotherapy drug for
exclusion from consolidated billing
prior to the point at which it is actually
assigned its own permanent J code.
Accordingly, we plan to add this drug
to the exclusion list, at such time as it
may be assigned a specific J code of its
own.
Comment: Several commenters
expressed their continued support for
the longstanding statutory exclusion
from consolidated billing of certain
specified types of customized prosthetic
devices, and recommended the
exclusion of two additional prosthetic
device codes, L5969 (‘‘ankle/foot power
assist, including motors’’) and L5987
(‘‘all lower extremity prosthesis, shank
foot system with vertical loading
pylon’’). One commenter further
recommended that certain customized
orthotic devices meeting the statutory
‘‘high-cost, low probability’’ criteria be
excluded as well.
Response: We note that code L5969
actually appears on the exclusion list
already under Major Category III.D
(‘‘Customized Prosthetic Devices’’),
where this particular L code has, in fact,
been listed ever since its initial
assignment in January 2014. Regarding
code L5987, we note that this particular
code had been recommended for
exclusion previously during the FY
2012 rulemaking cycle, along with two
other L codes that, like L5987, already
existed—but were not designated by the
Congress for exclusion—upon the
original 1999 enactment of the
customized prosthetic device exclusion
in the BBRA. In the FY 2012 SNF PPS
final rule (76 FR 48531, August 8, 2011),
we issued our decision to ‘‘. . . decline
to add these codes to the exclusion list,’’
explaining that
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46407
. . . our position has always been that the
BBRA’s discretionary authority to exclude
codes within certain designated service
categories applies solely to codes that were
created subsequent to the BBRA’s enactment,
and not to those codes that were already in
existence as of July 1, 1999 (the date that the
legislation itself uses as the reference point
for identifying the codes that it designates for
exclusion). As we explained in the FY 2010
final rule (74 FR 40354), this position reflects
the assumption that if a particular code was
already in existence as of that date but not
designated for exclusion, this meant that it
was intended to remain within the SNF PPS
bundle, subject to the BBRA Conference
Report’s provision for a GAO review of the
code set that was conducted the following
year (H.R. Rep. No. 106–479 at 854 (1999)
(Conf. Rep.)).
Regarding the suggestion on
excluding certain customized orthotic
devices under this authority, we have
explained repeatedly in this and
previous rules that the amendments
enacted in section 103 of the BBRA only
allow us to identify additional codes for
exclusion within each of the four
specified service categories:
chemotherapy items, chemotherapy
administration services, radioisotope
services, and customized prosthetic
devices (a category that is separate from
and does not encompass orthotics).
Accordingly, as we have already
indicated previously in the SNF PPS
final rules for FY 2001 (65 FR 46790,
July 31, 2000) and FY 2009 (73 FR
46436, August 8, 2008), because orthotic
devices do not fall within any of these
four specified service categories,
excluding them from consolidated
billing would require legislation by the
Congress to amend the law.
Comment: Several commenters on the
VBP provision additionally alleged that
there is an inherent ‘‘tension’’ between
VBP and consolidated billing (the SNF
PPS’s bundling requirement),
particularly with respect to portable xrays and other types of diagnostic
imaging, services that the commenters
characterized as playing a key role in
providing high-quality patient care. The
commenters stated that the inclusion of
these services within the PPS bundle
incentivizes SNFs to select suppliers of
diagnostic services solely on the basis of
price, without considering the quality of
the services. They also stated that the
current framework allows a practice in
which a supplier offers to furnish
deeply discounted services to the SNF’s
Part A residents in return for being
selected to handle the Part B services for
those of the SNF’s Medicare-eligible
residents who are in noncovered stays.
The commenters recommended that
diagnostic imaging services should be
unbundled altogether (or, alternatively,
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if left within the bundle, that the SNF
should be required to pay its supplier
the full Part B fee schedule amount for
them). They suggested that unbundling
these services would enable SNFs to
focus more on the quality of the services
themselves rather than on the details of
the billing process. Some of the
commenters additionally noted that
certain diagnostic radiology services
such as portable x-rays are split between
a bundled technical component (TC,
representing the diagnostic test itself)
and a separately billable professional
component (PC, representing the
physician’s interpretation of the test),
and they asserted that the portable xray’s transportation and setup should
appropriately be classified under the
separately billable PC rather than the
bundled TC, stating that the assignment
of a Level II HCPCS code is sufficient in
itself to identify a service as being an
excluded ‘‘physician’’ service in this
context.
Response: We have long recognized
the incentives to realize efficiencies in
providing care that are inherent in any
bundled payment requirement, along
with the attendant concerns about the
potential effect of those incentives on
quality of care. However, we do not
believe that the commenters, in citing
the SNF VBP as a new basis for
reiterating these recurring concerns,
have established sufficient justification
for unbundling diagnostic imaging
services from consolidated billing—an
action that, in any event, would require
legislation by the Congress. We also
note that the long-term care facility
requirements for participation, which
long predate the VBP legislation,
contain at 42 CFR 483.25 an overall
mandate for Medicare SNFs to provide
‘‘. . . the necessary care and services to
attain or maintain [each resident’s]
highest practicable physical, mental,
and psychosocial well-being, in
accordance with the comprehensive
assessment and plan of care.’’ In
addition, whenever a SNF elects to
obtain such services from an outside
source, the requirements at
§ 483.75(h)(2)(i) further confer on the
SNF the specific responsibility to obtain
‘‘. . . services that meet professional
standards and principles that apply to
professionals providing services in such
a facility.’’ Thus, a SNF that fails to
provide the appropriate quantity or
quality of care in accordance with this
mandate would jeopardize its
compliance with the requirements for
participation in the Medicare program.
Moreover, we do not accept the
commenters’ premise that placing the
billing responsibility with the SNF itself
has the effect of distracting from a focus
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on quality of care. To the contrary, the
consolidated billing provision was itself
established precisely to help promote
the overall coordination of high-quality
care in the SNF setting. We note that
prior to the enactment of this provision,
care for SNF residents could be
fragmented among a wide variety of
outside suppliers who were not required
to bill through the SNF. The resulting
dispersal of responsibility for resident
care among various outside suppliers
adversely affected quality (coordination
of care) and program integrity, as
documented in reports by both the
Office of the Inspector General (OIG)
and the Government Accountability
Office (GAO) (see OIG report no. OEI–
06–92–00863, ‘‘Medicare Services
Provided to Residents of Skilled
Nursing Facilities’’ (October 1994),
available online at https://oig.hhs.gov/
oei/reports/oei-06-92-00863.pdf, and
GAO report no. HEHS–96–18,
‘‘Providers Target Medicare Patients in
Nursing Facilities’’ (January 1996),
available online at https://www.gao.gov/
products/HEHS-96-18). Thus, the
enactment of consolidated billing
reflected a recognition that fully
enabling SNFs to ensure the overall
quality of their residents’ services
necessitated placing with the SNF itself
not only the professional but also the
financial responsibility for those
services.
As for the commenters’ suggestions on
requiring SNFs to pay suppliers the full
Part B fee schedule amount for a
bundled service, in the FY 2000 SNF
PPS final rule (64 FR 41677, July 30,
1999), we noted in response to previous,
similar suggestions that
. . . under current law, an SNF’s relationship
with its supplier is essentially a private
contractual matter, and the terms of the
supplier’s payment by the SNF must be
arrived at through direct negotiations
between the two parties themselves.
Accordingly, we believe that the most
effective way for a supplier to address any
concerns that it may have about the adequacy
or timeliness of the SNF’s payment would be
for the supplier to ensure that any terms to
which it agrees in such negotiations
satisfactorily address those concerns.
In that same final rule (64 FR 41677),
we also noted in response to previous,
similar concerns regarding supplier
discounts that
. . . our discussion of the relationship
between an SNF and its suppliers should not
be construed as addressing in any manner the
potential applicability of the statutory antikickback provisions, since matters relating
specifically to the enforcement of these
provisions lie exclusively within the purview
of the Office of the Inspector General.
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Finally, we do not share the view of
those commenters who would
categorize a portable x-ray service’s
transportation and setup as part of the
separately billable PC; rather, as noted
in § 90.5 of the Medicare Claims
Processing Manual, Chapter 13
(available online at https://www.cms.gov/
Regulations-and-Guidance/Guidance/
Manuals/Downloads/clm104c13.pdf):
. . . When a SNF resident receives a portable
x-ray service during the course of a Medicarecovered stay in the SNF, only the service’s
professional component (representing the
physician’s interpretation of the test results)
is a separately billable physician service
under Part B . . . By contrast, the technical
component representing the procedure itself,
including any associated transportation and
setup costs, would be subject to consolidated
billing (the SNF ‘‘bundling’’ requirement for
services furnished to the SNF’s Part A
residents), and must be included on the
SNF’s Part A bill for the resident’s covered
stay (Bill Type 21x) rather than being billed
separately under Part B . . . (emphasis
added).
Moreover, notwithstanding the
commenters’ assertions, the assignment
of a Level II HCPCS code to a particular
service would in no way automatically
equate to identifying it as an excluded
‘‘physician’’ service in this context.
Rather, under the regulations at 42 CFR
411.15(p)(2)(i), the only services that
can qualify for the physician service
exclusion from consolidated billing are
those that meet the criteria set forth in
42 CFR 415.102(a) for payment on a fee
schedule basis as a physician service.
Sections 415.102(a)(1) and (a)(3), in
turn, specify that such a service must be
furnished personally by a physician,
and must be a type of service that
ordinarily requires such performance.
These are criteria that a portable x-ray
service’s transportation and setup
would never meet, as the service’s
excluded PC relates solely to reading the
x-ray rather than taking it, and the
physician’s personal performance
clearly would not be required for
activities such as driving the supplier’s
vehicle to the SNF, or setting up the
equipment once it arrives there.
3. 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, these
services furnished by non-CAH rural
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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. A complete
discussion of assessment schedules, the
MDS, and the transmission software
(RAVEN–SB for Swing Beds) appears in
the FY 2002 final rule (66 FR 39562)
and in the FY 2010 final rule (74 FR
40288). As finalized in the FY 2010 SNF
PPS final rule (74 FR 40356 through
40357), effective October 1, 2010, nonCAH swing-bed rural hospitals are
required to complete an MDS 3.0 swingbed assessment which is limited to the
required demographic, payment, and
quality items. The latest changes in the
MDS for swing-bed rural hospitals
appear on the SNF PPS Web site at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
SNFPPS/. We received no
comments on this aspect of the
proposed rule.
D. Other Issues
1. SNF Value-Based Purchasing (VBP)
Program
a. Background
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(1) Overview
In recent years, we have undertaken a
number of initiatives to promote higher
quality and more efficient health care
for Medicare beneficiaries. These
initiatives, which include
demonstration projects, QRPs, and VBP
programs, have been implemented in
various health care settings, including
physician offices, ambulatory surgical
centers (ASCs), hospitals, nursing
homes, home health agencies (HHAs),
and dialysis facilities. Many of these
programs link a portion of Medicare
payments to provider reporting or
performance on quality measures. The
overarching goal of these initiatives is to
transform Medicare from a passive
payer of claims to an active purchaser
of quality health care for its
beneficiaries.
We view VBP as an important step
toward revamping how care is paid for,
moving increasingly toward rewarding
better value, outcomes, and innovations
instead of merely volume.
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(2) SNF VBP Report to Congress
Section 3006(a) of the Affordable Care
Act required the Secretary to develop a
plan to implement a VBP program under
the Medicare program for SNFs (as
defined in section 1819(a) of the Act)
and to submit that plan to Congress. In
developing the plan, this section
required the Secretary to consider
several issues, including the ongoing
development, selection, and
modification process for measures, the
reporting, collection, and validation of
quality data, the structure of valuebased payment adjustments, methods
for public disclosure of SNF
performance, and any other issues
determined appropriate by the
Secretary. The Secretary was also
required to consult with relevant
affected parties and consider experience
with demonstrations relevant to the SNF
VBP Program.
HHS submitted the Report to Congress
required under section 3006 of the
Affordable Care Act in March 2012. The
report explains that a significant
number of elderly Americans receive
care in SNFs/NFs, either as short-term
post-acute care or as long-term custodial
care, and that quality of care is a
significant concern for a subset of SNFs/
NFs. The report also states that the SNF
PPS does not strongly incentivize SNFs
to furnish high quality care to this very
fragile patient population. The report
concludes that the Medicare program
could incentivize SNFs to improve the
quality of care for their patients.
In the report, we explained our belief
that the implementation of a SNF VBP
Program is a central step in revamping
Medicare’s payments for health care
services to reward better value,
outcome, and innovations, rather than
the volume of care. We also explained
our belief that a SNF VBP Program
should promote the development and
use of robust quality measures,
including measures that assess
functional status, to promote timely,
safe, and high-quality care for Medicare
beneficiaries. We noted that the creation
of a SNF VBP Program would align with
numerous HHS and CMS efforts to
improve care coordination, and would
be consistent with the National Quality
Strategy and its aims of Better Care,
Healthy People and Communities, and
Affordable Care.
The full report is available on our
Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/Downloads/SNFVBP-RTC.pdf.
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46409
b. Statutory Basis for the SNF VBP
Program
Section 215 of PAMA added sections
1888(g) and (h) to the Act. Section
1888(g)(1) of the Act requires the
Secretary to specify a SNF all-cause allcondition hospital readmission measure
(or any successor to such a measure) not
later than October 1, 2015. Section
1888(g)(2) of the Act requires the
Secretary to specify an all-condition
risk-adjusted potentially preventable
hospital readmission rate for SNFs not
later than October 1, 2016. Section
1888(g)(3) of the Act directs the
Secretary to develop a methodology to
achieve high reliability and validity for
these measures, especially for SNFs
with a low volume of readmissions.
Section 1888(g)(4) of the Act makes the
pre-rulemaking Measure Applications
Partnership process of Section 1890A of
the Act optional for these measures.
Under section 1888(g)(5) of the Act, the
Secretary is directed to provide
quarterly confidential feedback reports
to SNFs on their performance on the
readmission or resource use measure
beginning on October 1, 2016. Under
section 1888(g)(6) of the Act, not later
than October 1, 2017, the Secretary must
establish procedures for making
performance data on readmission and
resource use measures public on
Nursing Home Compare or a successor
Web site. That paragraph also requires
that the procedures ensure that a SNF
has the opportunity to review and
submit corrections to the information
that is to be made public for it before
that information is made public.
Section 1888(h)(1)(A) of the Act
requires the Secretary to establish a SNF
VBP program under which value-based
incentive payments are made in a FY to
SNFs, and section 1888(h)(1)(B) of the
Act requires that the Program apply to
payments for services furnished on or
after October 1, 2018. Under section
1888(h)(2)(A) of the Act, the Secretary
must apply the readmission measure
specified under section 1888(g)(1) of the
Act for purposes of the Program, and
section 1888(h)(1)(B) of the Act requires
the Secretary to apply the resource use
measure specified under section
1888(g)(2) of the Act instead of the
readmission measure specified under
section 1888(g)(1) as soon as practicable.
Sections 1888(h)(3)(A) and (B) of the
Act require the Secretary to establish
performance standards for the measure
applied under section 1888(h)(2) of the
Act for a performance period for a FY
and that those performance standards
include levels of achievement and
improvement. In addition, in calculating
the SNF performance score for the
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measure under the Program, section
1888(h)(3)(B) of the Act requires the
Secretary to use the higher of
achievement or improvement scores.
Further, the performance standards
established under section 1888(h)(3) of
the Act must, under section
1888(h)(3)(C), be established and
announced by the Secretary not later
than 60 days prior to the beginning of
the performance period for the FY
involved.
Section 1888(h)(4) of the Act directs
the Secretary to develop a methodology
to assess each SNF’s total performance
based on the performance standards for
the applicable measure for each
performance period. Under section
1888(h)(4)(B) of the Act, SNF
performance scores for the performance
period for each FY must be ranked from
low to high.
Section 1888(h)(5) of the Act outlines
several requirements for value-based
incentive payments under the SNF VBP
Program. Under section 1888(h)(5)(A) of
the Act, the Secretary is directed to
increase the adjusted federal per diem
rate determined under section
1888(e)(4)(G) for services furnished by a
SNF by the value-based incentive
payment amount determined under
section 1888(h)(5)(B). This section also
directs that the value-based incentive
payment amount be equal to the product
of the adjusted federal per diem rate and
the value-based incentive payment
percentage specified under section
1888(h)(5)(C) of the Act for the SNF for
the FY. Section 1888(h)(5)(C) requires
the Secretary to specify a value-based
incentive payment percentage for a SNF
for a FY, which may include a zero
percentage. The Secretary is further
directed under section 1888(h)(5)(C) to
ensure that such percentage is based on
the SNF performance score for the
performance period for the FY, that the
application of all such percentages in a
FY results in an appropriate distribution
of value-based incentive payments, and
that the total amount of value-based
incentive payments for all SNFs for a FY
be greater than or equal to 50 percent,
but not greater than 70 percent, of the
total amount of the reductions to
payments for the FY under section
1888(h)(6), as estimated by the
Secretary.
Section 1888(h)(6) of the Act requires
the Secretary to reduce the adjusted
federal per diem rate for SNFs otherwise
applicable to each SNF for services
furnished by that SNF during the
applicable FY by the applicable percent,
which is defined in paragraph (b) as 2
percent for FY 2019 and subsequent
years. Section 1888(h)(7) of the Act
requires the Secretary to inform each
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SNF of its payment adjustments under
the Program not later than 60 days prior
to the FY involved, and under section
1888(h)(8) of the Act, the value-based
incentive payments calculated for a FY
apply only for that FY.
Section 1888(h)(9)(A) of the Act
requires the Secretary to publish SNFspecific performance information on the
Nursing Home Compare Web site or a
successor Web site, including SNF
performance scores and rankings.
Section 1888(h)(9)(B) of the Act requires
the Secretary to post aggregate
information on the SNF VBP 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.
We received a number of general
comments on the SNF VBP Program.
Comment: Commenters suggested that
we phase-in the SNFRM to ensure that
providers are fully capable of reporting
the measure accurately and to ensure
that it is fully valid and accurate.
Commenters suggested that such a
phase-in should include a period of
‘‘hold-harmless reporting’’ and data
collection that does not include
penalties or incentive payments.
Response: We do not have the
administrative discretion to phase-in the
SNF VBP Program as the commenter
suggests, since section 1888(h)(1)(B) of
the Act requires us to apply the Program
to payments for services furnished on or
after October 1, 2018. However, section
1888(g)(5) requires us to provide
quarterly, confidential feedback reports
to SNFs on their performance on
measures specified for the program
beginning October 1, 2016. We believe
those feedback reports will meet the
commenter’s request that we provide
feedback on the measure during a time
period that would not involve penalties
or incentive payments. Additionally, we
would remind commenters that the
SNFRM is a claims-based measure, and
therefore will not require any additional
data to be submitted by SNFs.
Comment: Commenters recommended
that proposed measures should align,
where possible, with existing quality
measures across settings and by
payment type (such as ACO or bundled
payments).
Response: We will take the
recommendation into account as we
further develop and implement the
Program.
Comment: Commenters urged us to
adopt an Extraordinary Circumstances
Exception process for the SNF VBP
Program to ensure that facilities do not
incur penalties under the program
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during major weather events or other
circumstances beyond their control.
Response: We will take the
recommendation into account as we
further develop and implement the
Program.
Comment: Commenters suggested that
we set up a regular workgroup to
discuss the SNF VBP Program’s
development with stakeholders.
Response: We intend to continue
outreach efforts to the SNF community
as we develop the Program.
Comment: Commenters suggested that
we should adopt a rule prohibiting
value-based incentive payments under
the SNF VBP Program to any SNF that
does not accurately report staffing data
or does not have sufficient nursing staff
to meet residents’ needs.
Response: We thank the commenters
for this suggestion and will consider it,
if legally feasible, as part of the
Program’s scoring policies in the future.
Comment: Commenters suggested that
we adopt a nutritional status domain
and implement a malnutrition-related
quality measure in the future for the
SNF VBP Program. Other commenters
suggested measures that are currently
displayed on Nursing Home Compare,
those that were part of the SNF VBP
demonstration, or those that are part of
the new SNF QRP.
Response: We do not believe we have
the authority to adopt measures
covering additional clinical topics
beyond those specified in sections
1888(g)(1) and (2) of the Act at this time.
Comment: Commenters urged us to
make SNF VBP Program data as
contemporaneous as possible.
Commenters noted that more recent
hospitalization data allow SNFs to
monitor their performance and better
realize the connection between their
performance rates and their payment
rates.
Response: We intend to make SNFs’
performance data available as quickly as
is practicable to ensure that facilities are
able to understand their performance
and undertake quality improvement
efforts.
Comment: Commenters encouraged us
to develop the statutorily-mandated
resource use measure specified under
section 1888(g)(2) of the Act as soon as
possible, and to share a timeline for
when the measure will replace the
SNFRM. Some commenters also stated
that the potentially preventable hospital
readmissions measure needs additional
testing and more detailed public
information.
Response: We thank the commenters
for this request. At this time, we have
not specified the resource use measure
under section 1888(g)(2) of the Act. We
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will make all details available,
including technical reports presenting
results of measure testing and technical
expert input, in the future and will seek
public comment.
We thank the commenters for this
general feedback, and will take it into
account in future rulemaking.
c. Skilled Nursing Facility 30-Day AllCause Readmission Measure (SNFRM)
(NQF #2510; Measure Steward: CMS)
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(1) Overview
Reducing hospital readmissions is
important for quality of care and patient
safety. Readmission to a hospital may be
an adverse event for patients and in
many cases imposes a financial burden
on the health care system. Successful
efforts to reduce preventable
readmission rates will improve the
quality of care furnished to beneficiaries
while simultaneously decreasing the
cost of that care. Hospitals and other
health care providers can work with
their communities to lower readmission
rates and improve patient care in a
number of ways, such as by ensuring
that patients are clinically ready to be
discharged, reducing infection risk,
reconciling medications, improving
communication with community
providers responsible for post-discharge
patient care, improving care transitions,
and ensuring that patients understand
their care plans upon discharge.
Many studies have demonstrated the
effectiveness of these types of inhospital and post-discharge
interventions in reducing the risk of
readmission, confirming that hospitals
and their partners have the ability to
lower readmission rates.1 2 3 These types
of efforts during and after a
hospitalization have been shown to be
effective in reducing readmission rates
in geriatric populations generally,4 5 as
well as for multiple specific conditions.
Moreover, such interventions can result
1 Gwadry-Sridhar FH, Flintoft V, Lee DS, Lee H,
Guyatt GH: A systematic review and meta-analysis
of studies comparing readmission rates and
mortality rates in patients with heart failure. Arch
Intern Med. 2004;164(21):2315–2320.
2 McAlister FA, Lawson FM, Teo KK, Armstrong
PW.: A systematic review of randomized trials of
disease management programs in heart failure.
AmJMed. 2001;110(5):378–384.
3 Krumholz HM, Amatruda J, Smith GL, et al.:
Randomized trial of an education and support
intervention to prevent readmission of patients with
heart failure. J Am Coll Cardiol. 2002;39(1):83–89.
4 Coleman EA, Parry C, Chalmers S, Min SJ.: The
care transitions intervention: Results of a
randomized controlled trial. Arch Intern Med.
2006;166:1822–8.
5 Naylor MD, Brooten D, Campbell R, Jacobsen
BS, Mezey MD, Pauly MV, Schwartz JS.:
Comprehensive discharge planning and home
follow-up of hospitalized elders: A randomized
clinical trial. JAMA. 1999;281:613–20.
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in cost saving. Financial incentives to
reduce readmissions will in turn
promote improvement in care
transitions and care coordination, as
these are important means of reducing
preventable readmissions.6 In its 2007
Report to Congress on Promoting Better
Efficiency in Medicare,7 MedPAC noted
the potential benefit to patients of
lowering readmissions and suggested
payment strategies that would
incentivize hospitals to reduce these
rates. Readmission rates are important
markers of quality of care, particularly
of the care of a patient in transition from
an acute care setting to a non-acute care
setting, and improving readmissions can
positively influence patient outcomes
and the cost of care.
We proposed to specify the SNF 30Day All-Cause Readmission Measure
(SNFRM) (NQF #2510) as the SNF allcause, all-condition hospital
readmission measure under section
1888(g)(1) of the Act. This measure
assesses the risk-standardized rate of allcause, all-condition, unplanned
inpatient hospital readmissions of
Medicare fee-for-service (FFS) SNF
patients within 30 days of discharge
from an admission to an inpatient
prospective payment system (IPPS)
hospital, CAH, or psychiatric hospital.
This measure is claims-based, requiring
no additional data collection or
submission burden for SNFs.
We also proposed to apply this
measure for purposes of the SNF VBP
Program under section 1888(h)(2)(A) of
the Act. We believe that this measure
will (1) incentivize SNFs to make
quality improvements that result in
successful transitions of care for
patients discharged from the hospital
(IPPS, CAH or psychiatric hospital)
setting to a SNF, and subsequently to
the community or to another post-acute
care setting, (2) reduce unplanned
readmission rates of these patients to
hospitals; and (3) align the SNF VBP
Program with the National Quality
Strategy priorities of safer, better
coordinated care and lower costs.8
We developed this measure based
upon the NQF-endorsed Hospital-Wide
All-Cause Unplanned Readmission
6 Coleman EA.: 2005. Background Paper on
Transitional Care Performance Measurement.
Appendix I. In: Institute of Medicine, Performance
Measurement: Accelerating Improvement.
Washington, DC: National Academy Press.
7 Medicare Payment Advisory Commission
(MedPAC). Report to Congress: Promoting Greater
Efficiency in Medicare; 2007. Available at https://
www.medpac.gov/documents/Jun07_
EntireReport.pdf. Accessed January 10, 2011.
8 Wilson, N. U.S. Department of Health and
Human Services, Agency for Healthcare Research
and Quality. (2014). National quality strategy:
Overview.
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46411
Measure (HWR) (NQF #1789) (https://
www.qualityforum.org/QPS/1789) 9
implemented in the Hospital Inpatient
QRP. To the extent methodologically
and clinically appropriate, we
harmonized the SNFRM with the HWR
measure specifications.
A discussion of the general comments
that we received on the SNFRM, and
our responses to those comments,
appears below.
Comment: One commenter expressed
concern about our proposal to adopt the
SNFRM, stating that it does not align
with the unplanned readmission
measure for IRFs (NQF #2502),
particularly in reporting period
duration. The commenter stated that we
should strive for alignment between
post-acute care settings, particularly
given the ongoing implementation of the
IMPACT Act.
Response: We thank the commenter
for their comments regarding alignment
of these measures. The SNFRM (NQF
#2510) is based on 12 months of data as
this ensures an accurate sample size for
calculating the Risk-Standardized
Readmission Rate (RSRR). However, 24
months of data were needed to ensure
sufficient sample sizes to reliably
estimate and develop the all-cause,
unplanned hospital readmission
measures used in the Inpatient
Rehabilitation Facility Quality
Reporting Program (NQF #2502) and the
Long-Term Care Hospital Quality
Reporting Program, due to the
substantially lower number of IRF and
LTCH stays.
While we recognize that the SNFRM
does not align with the unplanned
readmission measure for IRFs (#2502),
we are currently developing an
unplanned readmission measure for
IRFs that is analogous to the SNFRM in
that it assesses readmissions among IRF
patients following discharge from an
acute care hospital. This second IRF
measure is intended to exist in tandem
with the existing IRF measure #2502,
which assesses readmissions for 30 days
following discharge from the IRF.
Comment: Some commenters
supported our proposal to adopt the
SNFRM, noting that the measure is
consistent with other CMS readmission
measures, and that it will decrease
costs, improve patient safety, and
promote the best possible clinical
outcomes. Commenters suggested that
we consider adopting additional
measures in the future in the SNF VBP
Program that cover resource use,
9 Adopted for the Hospital IQR Program in the FY
2013 IPPS/LTCH PPS Final Rule (77 FR 53521
through 53528).
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functional outcomes, and return to the
community following discharge.
Response: We do not have the
authority to adopt additional measures
in the SNF VBP Program beyond those
specified in sections 1888(g)(1) and (2)
of the Act.
Comment: Some commenters
suggested that we either adopt a
readmission measure that includes all
SNF patients, regardless of payer, or
clarify that the SNFRM is an ‘‘all-cause
fee-for-service measure’’ because it
excludes Medicare Advantage
beneficiaries.
Response: This measure is based on
FFS claims, consistent with other
hospital readmission measures used in
other programs. The measure as
specified requires Medicare claims to
determine if any readmissions are
deemed to be planned or unplanned and
for comprehensive risk adjustment.
Comment: One commenter
recommended that we ask the MAP to
review PointRight OnPoint-30 SNF
Rehospitalizations (NQF #2375) before
taking a final position on the SNFRM
(NQF #2510). The commenter explained
that #2375 is an MDS-based measure
that captures patients regardless of
payer type and also includes
observation admissions. The commenter
further noted that #2375 risk adjusts for
functional and clinical symptoms that
are strong predictors of readmissions.
Response: We recognize the
desirability of implementing an allpayer readmission measure. However,
we have some concerns with including
the measure (NQF #2375) in the SNF
VBP program. The MDS-based measure
excludes readmissions that occur after
discharge from the SNF, which creates
a perverse incentive for SNFs to
discharge patients prematurely to avoid
being penalized if the patients are
considered a high risk for readmission.
The MDS-based measure also does not
exclude planned readmissions which
are not indications of poor quality.
Additionally, while NQF #2375 adjusts
for functional and clinical symptoms,
analyses conducted jointly by the
developers of that measure and the
SNFRM concluded that there is no
substantial distinction in the risk
models’ capacity to assess readmission
rates at the facility level.
Comment: One commenter asked that
we clarify that the MAP process is not
restricted to reviewing and commenting
only on CMS-sponsored measures or
measures presented by CMS to the
MAP, per section 1890 of the Act. The
commenter also requested that we
clarify that the input from the MAP is
not with the view that the measure is
used for VBP, as they believed that a
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measure for payment should be
evaluated in a different manner.
Response: It is correct that other
measures are eligible for consideration
in the MAP process. While the MAP
provides input on measures selected by
the Secretary, the pre-rulemaking
provisions of the Act do not restrict the
MAP from reviewing or recommending
measures and methodologies in lieu of
those under consideration by the
Secretary. Therefore, we refer readers to
the MAP Web site at https://
www.qualityforum.org/map/.
Additionally, we intend to provide the
commenters’ input to the NQF.
In addition, at times we request
additional measures from external
stakeholders and measure developers,
which are also reviewed by the MAP.
The MAP’s input is responsive to the
particular program for which its review
was sought. In this case, the SNFRM
was submitted via an ad hoc Measures
Under Consideration list to the MAP for
consideration in SNF–VBP. The MAP’s
2015 recommendations, available at
https://www.qualityforum.org/WorkArea/
linkit.aspx?LinkIdentifier=id&
ItemID=78711, show that the MAP
supported the SNFRM’s adoption for the
SNF VBP Program.
Comment: One commenter opposed
the proposed SNFRM, stating that the
measure is self-reported because it is
based on MDS information and that it is
industry-developed and controlled.
Response: The proposed SNFRM is
based on Medicare claims data and the
measure does not use MDS information.
Furthermore, the proposed measure was
developed by CMS working with an
independent CMS contractor, RTI
International, and was not industrydeveloped. The proposed measure was
endorsed by the National Quality Forum
(NQF), and its specifications are
available in our technical report, which
is available on our Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
Downloads/SNFRM-Technical-Report3252015.pdf.
Comment: Some commenters
expressed concern that SNFs will not
have access to the data used to calculate
the SNFRM, and will therefore not be
able to validate CMS’s calculations.
Response: While we intend to make as
much information related to SNFRM
performance as possible available to
SNFs through confidential quarterly
feedback reports required under section
1888(g)(5) of the Act, we understand
that claims-based quality measurement
is difficult for providers to replicate. It
would require familiarity with a number
of data sources that are used to develop
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the risk-adjustment model for SNFRM
in order to account for variation across
SNFs in case-mix and patient
characteristics predictive of readmission
(including the MedPAR, Medicare
Enrollment Database (EDB), Medicare
Denominator files, Agency for
Healthcare Research & Quality (AHRQ)’s
Clinical Classification Software (CCS)
groupings of ICD–9 codes, and CMS’s
hierarchical condition category (HCC)
mappings of ICD–9 codes). We view this
as a necessary compromise to minimize
reporting burden on participating SNFs
by using claims data while ensuring that
we obtain timely data for quality
measurement.
Comment: One commenter suggested
that our longer-term goal should be to
align the SNFRM with other relevant
hospitalization measures planned for
use, such as those being developed by
states under section 1115 waivers and
new value-based initiatives for the
Medicare fee-for-service program.
Response: We thank the commenter
for this feedback, and will consider how
best to align our programs with these
efforts in the future.
Comment: Some commenters
expressed concerns about our proposal
to adopt the SNFRM, stating that further
vetting of the measure is warranted
given commenter’s belief that research
cited on the measure is spare and
includes only effectiveness studies
limited to certain conditions.
Response: The SNFRM was developed
using the Measures Management System
(MMS) Blueprint, a process that
included input from a TEP and a public
comment period. The measure was also
reviewed by the NQF, and supported by
that body for endorsement in December
2014. We believe that this represents
sufficient vetting for the purpose of
implementing a measure in a VBP
program. We welcome additional input
regarding the research supporting or
questioning the appropriateness of this,
or any other measure.
Comment: One commenter urged us
to consider adjusting the SNFRM for
situations beyond facilities’ control,
such as family members insisting on a
patient being hospitalized, and for
patients with increased risks of
hospitalization, including medically
complex, frail elderly patients and those
with certain primary diagnoses. The
commenter also noted that avoidable
hospital admissions frequently result
from poorly managed transitions, and
suggested that we investigate
meaningful ways to capture and
incentivize care transitions using this
measure.
Response: The SNFRM, which was
endorsed by the NQF, has been risk
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adjusted for case-mix to account for
differences in patient populations. The
goal of risk adjustment is to account for
these differences so that providers who
treat sicker or more vulnerable patient
populations are not unnecessarily
penalized for factors that are outside of
their control. The current measure
accounts for: Principal diagnosis from
the Medicare claim corresponding to the
prior proximal hospitalization as
categorized by AHRQ’s CCS groupings,
length of stay during the patient’s prior
proximal hospitalization, length of stay
in the intensive care unit (ICU), endstage renal disease (ESRD) status,
whether the patient was disabled, the
number of prior hospitalizations in the
previous 365 days, system-specific
surgical indicators, individual
comorbidities as grouped by HCCs or
other comorbidity indices, and a
variable counting the number of
comorbidities if the patient had more
than two HCCs. Many of the factors,
such as family preference, suggested by
the commenter are not feasibly captured
by any existing data source of which we
are aware. The medical complexity of
patients is captured to the extent
possible through the comorbidity data
described above. In this way, we are
able to capture poorly managed
transitions through risk adjusted
readmissions rates.
Comment: One commenter
encouraged us to consider creating
safeguards for SNFs participating in the
Program to ensure that patients are fully
protected from unintended
consequences resulting from the
SNFRM’s adoption, potentially
including functional declines and
resident deaths. The commenter
suggested that a companion measure of
death and decline of residents would
determine whether SNFs improperly
avoided hospitalizing residents who
should have been hospitalized.
Response: We intend to monitor the
effects of the SNFRM on clinical care
closely, and we intend to take any
necessary steps to ensure that SNFs do
not avoid hospitalizing patients.
Additional measures may be
implemented in other SNF-related
programs such as the QRP. However, as
stated above, we do not have the
authority to adopt additional measures
under the Program beyond the ones
required under sections 1888(g)(1) and
(2) of the Act.
(2) Measure Calculation
The SNFRM estimates the riskstandardized rate of all-cause,
unplanned, hospital readmissions for
SNF Medicare FFS beneficiaries within
30 days of discharge from their prior
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proximal acute hospitalization. The SNF
admission must have occurred within
one day after discharge from the prior
proximal hospitalization. The prior
proximal hospitalization is defined as
an inpatient admission to an IPPS, CAH,
or a psychiatric hospital. Because the
measure denominator is based on SNF
admissions, each Medicare beneficiary
may be included in the measure
multiple times within a given year if
they have more than one SNF stay
meeting all measure inclusion criteria
including a prior proximal
hospitalization.
Patient readmissions included in the
measure are identified by examining
Medicare claims data for readmissions
of SNF Medicare FFS beneficiaries to an
IPPS, or CAH occurring within 30 days
of discharge from the prior proximal
hospitalization. If the patient was
admitted to the SNF within 1 day of
discharge from the prior proximal
hospitalization and the hospital
readmission occurred within the 30-day
risk window, it is counted in the
numerator regardless of whether the
patient is readmitted directly from the
SNF or has been discharged from the
SNF. Because patients differ in
complexity and morbidity, the measure
is risk-adjusted for patient case-mix.
The measure also excludes planned
readmissions, because these are not
considered to be indicative of poor
quality of care by the SNF. Details
regarding how readmissions are
identified are available in our SNFRM
Technical Report.10
The SNFRM (NQF #2510) assesses
readmission rates while accounting for
patient demographics, principal
diagnosis in the prior hospitalization,
comorbidities, and other patient factors.
While estimating the predictive power
of patient characteristics, the model also
estimates a facility-specific effect
common to patients treated at that SNF.
The SNFRM is calculated based on
the ratio, for each SNF, of the number
of risk-adjusted all-cause, unplanned
readmissions to an IPPS or CAH that
occurred within 30 days of discharge
from the prior proximal hospitalization,
including the estimated facility effect, to
the estimated number of risk-adjusted
predicted unplanned inpatient hospital
readmissions for the same patients
treated at the average SNF. A ratio above
1.0 indicates a higher than expected
readmission rate, or lower level of
quality, while a ratio below 1.0
indicates a lower than expected
10 Available on the Nursing Home Quality
Initiative Web site at https://www.cms.gov/
Medicare/Quality-nitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
index.html?redirect=/nursinghomequalityinits/.
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readmission rate, or higher level of
quality. This ratio is referred to as the
standardized risk ratio or SRR. The SRR
is then multiplied by the overall
national raw readmission rate for all
SNF stays. The resulting rate is the riskstandardized readmission rate (RSRR).
The full methodology is detailed in the
SNFRM Technical Report.
The patient population includes SNF
patients who:
• Had a prior hospital discharge
(IPPS, CAH or psychiatric hospital)
within 1 day of their admission to a
SNF.
• Had at least 12 months of Medicare
Part A, FFS coverage prior to their
discharge date from the prior proximal
hospitalization.
• Had Medicare Part A, FFS coverage
during the 30 days (the 30-day risk
window) following their discharge date
from the prior proximal hospitalization.
A discussion of the general comments
that we received on the SNFRM
measure calculation, and our responses
to those comments, appears below.
Comment: One commenter expressed
concern about the SNFRM’s
readmission window, noting that just
over one-third of SNF stays exceed the
30-day readmission window. The
commenter suggested that adopting the
30-day window as proposed could
relieve SNFs of accountability for
longer-stay patients and could create
incentives for SNFs to delay needed
care until after day 30. The commenter
further stated that SNFs should be
responsible for every readmission that
occurs while the beneficiary is in the
SNF.
Response: We agree with the
commenter’s concerns that SNFs should
be accountable for longer-stay patients
who are admitted to an acute care
hospital. The SNFRM is designed to
assess failed transitions from an acute
care hospital to the SNF, and is not
intended to capture all hospitalizations
that may occur in a SNF population.
Including all admissions beyond 30
days in the population would attenuate
the association between the transitions
of care at the proximate discharge from
an acute care hospital to the
readmission.
Comment: Some commenters stated
that the SNFRM does not hold SNFs
fully accountable for transitions to the
next care setting, and suggested that we
should adopt separate measures of
readmissions after discharge from the
SNF and from the hospital. One
commenter stated that the SNFRM’s
measurement period should capture
rehospitalizations within 90 days, not
just 30 days. The commenter noted that
other efforts to reduce rehospitalizations
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focus on a 90-day time period, and
suggested that the 30-day period may
reflect poor hospital care more than care
problems in the SNF.
Response: The 30-day readmission
window was developed to harmonize
with other hospital readmission
measures and reflects a transitional time
period during which the acute care
hospital and SNF are responsible for
coordinating the care of a patient
moving from one setting to another.
While there is no definitive timeframe
for which such a measure may be
applied, the 30-day window is
consistent with similar measures
applied in other VBP programs, such as
the ESRD Quality Incentive Program
and the Hospital Readmission
Reduction Program, as well as a number
of QRPs. Furthermore, this 30-day posthospital discharge window was
reviewed by a TEP. Analysis of
readmission rates showed no patterns
indicating that using a shorter or longer
period would produce very different
comparative results, though the overall
rates would change. In addition, the
NQF Standing Committee generally
agreed that 30 days post-hospital
discharge is an accepted standard for
measuring readmissions. Longer
windows may be subject to greater
‘‘noise’’ or statistical variability in the
readmission rate. The measure as
specified has the potential for this
unintended consequence of delaying
hospital care beyond the 30-day
readmission window, but this issue may
occur with any selected day threshold.
We will be closely monitoring this and
continue to analyze whether there are
changes in the number of days to
hospital readmission over time to assess
whether a change to the readmissions
window is needed for this measure in
the future.
Comment: One commenter expressed
concern about the time lag between the
end of the measurement period and the
release of clean, adjudicated claims
data. The commenter was concerned
that these delays could affect timely
notice and payment for SNFs
participating in the Program.
Response: We share the commenters’
concern. As required by statute, we
intend to provide quarterly feedback to
SNFs to ensure that facilities have as
much information as possible to inform
their quality improvement efforts.
Comment: Commenters expressed
concern that while the SNFRM accounts
for principal diagnosis, that diagnosis
may not be the reason for admission to
a SNF. Commenters suggested that the
SNFRM should also account for
comorbidities, diagnoses from prior
hospitalizations during the prior year,
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length of stay during the prior proximal
hospitalization, length of stay in the
ICU, body system specific surgical
indicators, ESRD status, disability
status, and number of prior
hospitalizations during the previous
year. Commenters also requested that
we develop a list of comorbidities that
are being evaluated in the SNFRM’s risk
adjustment model.
Response: We would like to clarify
that the SNFRM is risk-adjusted for all
of the factors cited by the commenter.
The SNFRM accounts for all of the
factors proposed in the comment above,
including first diagnosis from the
Medicare claim corresponding to the
prior proximal hospitalization as coded
by the AHRQ’s CCS, length of stay
during the patient’s prior proximal
hospitalization, indicator of a stay in the
ICU, ESRD status, whether the patient
was disabled, the number of prior
hospitalizations in the previous 365
days, system-specific surgical
indicators, individual comorbidities as
grouped by CMS’s (HCCs, and a variable
counting the number of comorbidities if
the patient had more than two HCCs. To
capture comorbidities, we used the
secondary medical diagnoses listed on
the patient’s prior proximal hospital
claim as well as all diagnoses listed on
acute care hospitalizations that occurred
in the prior 12 months. We refer the
commenter to the Technical Report for
the SNFRM for additional information,
which can be found on the Nursing
Home Quality Initiative Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
index.html.
Comment: Some commenters
disagreed with our proposal to adopt a
measure based on claims data, stating
that determining readmission rates will
be difficult for SNFs since claims data
are cumbersome to use or access.
Commenters stated that the SNFRM will
not provide meaningful insights or
otherwise impact quality improvement
efforts when facilities are unable to
interpret or access the data.
Response: This measure was
developed to harmonize with other
hospital-based measures that are claimsbased. Despite the commenter’s concern
that these data are difficult to access, the
measure developer (RTI) cited evidence
that these data are both reliable and
valid. Further detail on this evidence is
available in the SNFRM Technical
Report, Section 3.5 (Validity Testing),
available on the Nursing Home Quality
Initiative Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-
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Instruments/NursingHomeQualityInits/
index.html.
Furthermore, we intend to make
performance reports available to
facilities that are easy to interpret and
present information on the facility-level
readmission rates and relative standing
on this measure, rather than information
from the claims data directly. We intend
to make SNFs’ performance data
available as quickly as is practicable.
This will serve to provide information
on a facility’s performance and aid in
informing quality improvement efforts
at the facility level.
Comment: One commenter stated that
readmission measures should be
‘‘normalized’’ instead of reported in
simple percentage rates. The commenter
believed that reductions in hospital
admissions could result in more
measured readmissions, even if the
normalized readmission rate has
remained constant. The commenter also
suggested that undue variation may
result for smaller facilities and fewer
admissions.
Response: The percentages computed
by the measure are normalized in the
sense that they are computed with risk
adjustment and may be compared to one
another and to the national rate for
SNFs. A ratio of the risk-adjusted
predicted rate for each facility to the
expected rate for the same patients at
the average facility produces a
normalized value (referred to as the
standardized risk ratio) which is 1.0 for
a facility with readmissions at the
expected rate for its own patients, and
higher or lower than 1.0 if the
readmission rate is higher or lower. For
ease of interpretation, this standardized
risk ratio is converted to a standardized
rate by multiplying it by the national
raw rate. This is an accepted method for
producing standardized rates that are
comparable across facilities. There is no
external percentage target that every
facility must meet and the national
mean rate is driven by the data for the
measurement period. The national mean
may go up or down over time reflecting
a changing pool of patients, medical
conditions, and treatments.
Variation in rates that may occur in
facilities with low volume is dealt with
by averaging the volatile facility data
with the national mean when the
hierarchical models are used. In
addition, we will consider appropriate
facility volume thresholds for reporting
depending on the use of the measure.
Comment: One commenter
recommended that we adopt a
minimum of 30 qualified FFS
admissions per 12-month period to
calculate a statistically valid SNFRM
rate. The commenter further stated that
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any SNFs with fewer events should be
excluded from the measure’s
calculation.
Response: We will consider whether
we should establish a minimum number
of qualifying admissions for the SNFRM
in future rulemaking. The SNFRM
utilizes shrinkage estimates to address
the possibility of undue variation for
smaller facilities. This is a design
feature common to many of our
readmission measures, including those
implemented in the aforementioned
programs, to ensure statistically valid
rates.
Comment: One commenter stated that
we should only count readmissions that
occur while the patient resides in the
SNF, not after discharge. The
commenter stated that measure
readmissions within the 30-day window
but after SNF discharge necessitates
measurement of 30-day
rehospitalization rates for other
providers as well. Commenters also
noted that PAMA does not specify that
the SNF measure align with the
hospital’s 30-day window and the Act
uses ‘‘Skilled Nursing Facility Measure’’
throughout, which some commenters
read to mean SNF only, not SNF plus
follow on care after discharge.
Response: We agree that readmission
rates for other providers are necessary,
and this is one reason we have taken
steps to implement readmissions
measures in multiple settings across a
wide variety of relevant quality
programs. We believe that excluding
readmissions that occur after discharge
creates a perverse incentive for facilities
to prematurely discharge patients who
represent the highest risk for
readmission to avoid penalty. Given that
this measure is the sole determinant of
a VBP program for SNFs, we believe it
is appropriate to include readmissions
that occur post-discharge but within the
30-day window, aligning with other
readmission measures implemented by
CMS. The goal of this measure is to
capture readmissions that are
attributable to care provided by the
SNF, even those that occur after
discharge. We have already established
a panel of readmission measures (such
as those utilized for hospitals, ESRD
care, IRFs, and LTCHs) that similarly
seek to identify readmissions
attributable to care received within the
facility, even if the patient has been
discharged. Those developed for ESRD
facilities and Home Health agencies
follow a 30-day window as well. We
believe that the 30-day window is
consistent with PAMA and that it is also
consistent with the standard
implemented in multiple settings.
Absent a compelling reason to limit the
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measure to within stay, and given the
potential for unintended consequences
if such a measure were implemented as
the sole determining factor of a VBP
program, we believe remaining
consistent with other programs is
appropriate. We might consider a purely
within-stay measure were it paired with
a post-discharge measure, as this would
allow us to avoid unintended
consequences to patients, such as
inappropriate early discharge from the
SNF, but the statutory mandate does not
allow us to implement additional
measures in the SNF–VBP program.
Comment: One commenter requested
that we clarify whether the SNFRM
includes all hospitalizations billed to
Medicare or if it is limited to
hospitalizations of residents who are in
a Part A stay in a SNF. The commenter
suggested that a broader measure of
readmissions, including Medicare
claims for dually-eligible residents not
in a Part A stay or for private-pay
residents could be used.
Another commenter suggested that we
explore merging FFS and Medicare
Advantage data sets given the relative
prevalence of MA patients in the SNF
setting. The commenter also noted that
the IMPACT Act does not separate
Medicare beneficiaries by MA status.
The commenter also recommended that
facilities be allowed to complete and
submit a combined Admission
Assessment with the 5-day Assessment
for Medicare Advantage beneficiaries to
track readmission outcome data for all
payer types in the facility.
Response: The index stays that are
included in the proposed SNFRM are
for those that have FFS Part A Medicare
enrollment. We do not have claims data
for managed care, private pay, or
Medicaid residents who may be
receiving skilled services. Thus, this
measure only includes Medicare FFS
patients.
For private-pay residents, we do not
always have claims for the index
hospital stay (the proximate stay at an
acute-care hospital that precedes care
with a SNF and defines the
denominator), even if the related
readmissions could be identified in
Medicare data. In addition, we do not
have reliable sources of data for
Medicare Advantage patients. The most
reliable data available for determining
readmissions during a SNF stay are for
Part A FFS beneficiaries.
We agree that as penetration of the
Medicare Advantage market in the SNF
setting increases, finding ways of
including readmissions for these
patients should be a priority. We will
continue to explore ways to include
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these patients in future years, given the
differences in data sources.
Comment: Another commenter also
expressed concern that the SNFRM
captures only Medicare FFS
beneficiaries. The commenter noted that
the SNF VBP Program’s statute does not
specifically restrict the measure to FFS
beneficiaries, and urged us to find an
all-payer measure. The Commenter
further noted that the SNFRM does not
capture hospital admissions that are
classified as ‘‘observation status,’’ which
are paid under Part B, and stated that
the measure should be broadened to
include residents not in a Medicare Part
A stay.
Response: At present, we are not able
to include all payers in the SNFRM, as
the measure is dependent upon
Medicare claims data to identify
readmissions and risk-adjust for patient
comorbidities. While an all-payer
measure based on the MDS does exist,
it has several characteristics that we
believe are potentially problematic for
use in a VBP program. The MDS-based
measure excludes readmissions that
occur after discharge from the SNF,
which creates a perverse incentive for
SNFs to discharge patients prematurely
to avoid being penalized if they are
considered a high risk for readmission.
The MDS-based measure also does not
exclude planned readmissions, which
are not indications of poor quality. We
do not believe observation stays are
appropriate for inclusion in the
readmission measure, because the
statute requires a measure of
readmissions, not of rehospitalizations,
which could also include ED and
outpatient visits, including observation
stays. We have tested the inclusion of
observation stays, and note that doing so
would have little or no impact on
facility assessment by the measure. In
addition, evidence suggests that the
number of observation stays of patients
originating from a SNF is quite small in
comparison to the total number of SNF
stays (0.7 percent of all SNF stays), and
very few readmissions occur after an
observation stay. Including observation
stays from the SNF hospital readmission
measure will not make a meaningful
difference in the SNF facility-level rate
of hospital readmissions or in the
relative ranking of SNF providers
according to this measure.
Comment: One commenter requested
that we clarify whether the SNFRM’s
condition list has been tested for the
ICD–10 transition scheduled to be
completed on October 1, 2015.
Response: We will monitor and test
the measure performance and update
the risk adjustment model with the
transition to ICD–10. We are prepared
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for the implementation of ICD–10 for
this measure. Mappings of ICD–10 codes
for the diagnoses and procedures have
been prepared by the AHRQ for the CCS
groups used in the risk-adjustment
models. Similarly, mappings to the HCC
groups have been done. These are used
in the risk adjustment of the measure
and the definition of planned
readmissions. The effects of the change
of codes will be system-wide and the
models will be re-estimated when the
necessary new data become available
with the implementation of ICD–10.
Comment: One commenter suggested
that we use SNFs’ actual readmission
rate rather than predicted actual. The
commenter noted that the predicted
actual rate mutes the differences in rates
for small sample size (for example, a
facility with an actual count of 0
readmissions could have a projected
rate that is greater than 0).
Response: This measure and several
other post-acute care measures were
designed to align with the HospitalWide Readmission measure for all-cause
readmissions, and these measures
utilize a hierarchical modeling approach
that relies on generating a predicted rate
consistent with recommendations made
in the 2011 Committee of Presidents of
Statistical Societies commissioned
paper Statistical Issues in Assessing
Hospital Performance.11 This decision
was made based on the validity of
calculating the standardized risk ratio
(SRR), which is the predicted number of
readmissions at the facility divided by
the expected number of readmissions
for the same patients if these patients
had been treated at the average SNF.
The predicted number of readmissions
for each SNF is calculated as the sum of
the predicted probability of readmission
for each patient in the facility, including
the SNF-specific (random) effect. The
measure developer (RTI International)
also designed a test to explore
calibration over ranges of predicted
probabilities by doing a comparison of
the observed and predicted
readmissions by decile (for a table of
results, please refer to the SNFRM
Technical Report, Section 3.3 Model
Validation). These results indicate that
the difference between the predicted
number of readmissions and the
observed number of readmissions in
percentage points is minimal, less than
11 The COPSS–CMS White Paper Committee:
Arlene S. Ash, Ph.D.; Stephen E. Fienberg, Ph.D.;
Thomas A. Louis, Ph.D.; Sharon-Lise T. Normand,
Ph.D.; Therese A. Stukel, Ph.D., Jessica Utts, Ph.D.
Available for download here: https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/HospitalQualityInits/Downloads/
Statistical-Issues-in-Assessing-HospitalPerformance.pdf.
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one percentage point across deciles of
expected rates of readmission, which
suggests that the differences in rates will
not be muted by using the predicted
rate.
Comment: One commenter suggested
that we increase the minimum
denominator size to address small
volume variation. The commenter noted
many SNFs admit fewer than 50
Medicare FFS beneficiaries per year and
some of these would be excluded if the
proposed minimum denominator size of
25 stays is adopted. They also noted that
for facilities with Ns smaller than 40,
the confidence intervals of the
readmission rate start to increase; for Ns
smaller than 30, the confidence
intervals increase rapidly. The
commenter recommended that we
should show both the impact that
different minimum denominator sizes
have on the number of SNFs excluded
and the range of confidence intervals of
the SNFs rehospitalization rates for Ns
smaller than 50 to below 20. They also
recommended that bootstrap analysis be
conducted to test minimum
denominator size to see how the
confidence interval around small
facilities increases as the denominator
decreases as was done for NQF #2375.
Response: We did not propose a
minimum denominator size of 25 stays,
nor did we specify any minimum SNF
size for inclusion. We will consider
whether we should establish a
minimum denominator for the SNFRM
in future rulemaking along with the
scoring methodology we are developing
for the SNF VBP Program.
(3) Exclusions
Patients whose prior proximal
hospitalization was for the medical
treatment for cancer are excluded.
Analyses of this population during
measure development showed them to
have a different trajectory of illness and
mortality than other patient
populations, which is consistent with
findings in studies in other patient
populations.12
SNF stays excluded from the measure
are:
• SNF stays where the patient had
one or more intervening post-acute care
(PAC) admissions (inpatient
rehabilitation facility (IRF), long-term
care hospital (LTCH), or another SNF)
which occurred either between the prior
proximal hospital discharge and SNF
admission (from which the patient was
readmitted) or after the SNF discharge
12 National Quality Forum. ‘‘Patient Outcomes:
All-Cause Readmissions Expedited Review 2011’’.
July 2012. pp. 12.
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but before the readmission, within the
30-day risk window.
• SNF stays with a gap of greater than
1 day between discharge from the prior
proximal hospitalization and the SNF
admission.
• SNF stays in which the patient was
discharged from the SNF against
medical advice (AMA).
• SNF stays in which the principal
diagnosis for the prior proximal
hospitalization was for rehabilitation
care; fitting of prostheses and for the
adjustment of devices.
• SNF stays in which the prior
proximal hospitalization was for
pregnancy.
• SNF stays in which data were
missing on any variable used in the
SNFRM construction.
Readmissions within the 30-day risk
window that are usually considered
planned due to the nature of the
procedures and principal diagnoses of
the readmission are also excluded from
the measure. In addition to the list of
planned procedures is a list of diagnoses
(provided in the SNFRM Technical
Report), which, if found as the principal
diagnosis on the readmission claim,
would indicate that the usually planned
procedure occurred during an
unplanned acute readmission. In
addition to the HWR Planned
Readmission Algorithm, the SNFRM
incorporates procedures that are
considered planned in post-acute care
settings as identified in consultation
with TEPs. Full details on the planned
readmissions criteria used, including
the additional procedures considered
planned for post-acute care may be
found in the SNFRM Technical Report.
Details regarding the TEP proceedings
can be found in the SNFRM TEP Report.
A discussion of the general comments
that we received on the SNFRM
exclusions, and our responses to those
comments, appears below.
Comment: One commenter suggested
that we should not limit the SNFRM to
a 30-day readmission window, and
should hold SNFs accountable for all
readmissions that occur while a
beneficiary is in a SNF. The commenter
also suggested that we adopt a SNF
measure that holds SNFs accountable
for readmissions 30 days after discharge
from the SNF, which commenters stated
would help ensure smooth care
transitions.
Response: We agree with the
commenter’s concerns that SNFs should
be accountable for longer-stay patients
who are readmitted to an acute care
hospital. The SNFRM is designed to
assess failed transitions from acute care
to the SNF, and is not intended to
capture all hospitalizations that may
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occur in a SNF population. Including all
admissions beyond 30 days in the
population would attenuate the
association between the transitions of
care at the proximate discharge from an
acute care hospital to the readmission.
Adding additional measures to account
for readmissions post discharge from the
SNF seems a reasonable suggestion, but
we lack the statutory authority to
include additional quality measures in
the SNF VBP program.
Comment: One commenter expressed
concern about the SNFRM’s exclusion
of patients admitted to SNFs from
inpatient rehabilitation facilities and
long-term care hospitals. The
commenter agreed that these patients
may be in a different phase of recovery
than acute care hospital patients, but
suggested that they should still be
included in the measure with a separate
risk adjustment method.
Response: We excluded patients who
have intervening IRF or LTCH
admissions before their first SNF
admission. While developing the
measure specifications, we found that
these patients started their SNF
admission later in the 30-day
readmission window and received other
additional types of services as compared
with patients admitted directly to the
SNF from the prior proximal
hospitalization. Thus, they are clinically
different, and their risk for readmission
is different from the rest of SNF
admissions. We report details on this
exclusion in the SNFRM Technical
Report.13 SNF patients with intervening
IRF/LTCH stays had the lowest rates of
readmission (8.6 percent) as compared
with those with no intervening IRF/
LTCH stay.
Additionally, we found that those
with intervening IRF/LTCH admissions
had longer hospital lengths of stay and
more prior proximal hospitalizations
involving surgical procedures compared
to those without an intervening stay.
This observation supports the rationale
that patients who had intervening IRF/
LTCH stays are entering the SNF at a
later stage of their recovery and are
therefore at a different risk for
readmission than patients who were
admitted directly to the SNF from their
prior proximal hospitalization. This
issue also impacts a relatively small
number of SNF stays; 6 percent have an
intervening PAC stay (IRF, LTCH, or
another SNF) or go home from their
prior proximal hospitalization and are
13 Available at: https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-Assessment-Instruments/
NursingHomeQualityInits/Downloads/SNFRMTechnical-Report-3252015.pdf.
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later admitted to a SNF within the 30day readmission window.
Combined, these analyses provide
justification for excluding SNF
admissions with intervening IRF or
LTCH admissions, or with multiple SNF
stays, by showing these exclusions will
not have a substantial effect on the
SNFRM. Patients with multiple PAC
stays after a prior proximal
hospitalization are not systematically
different from those with only one SNF
stay with regard to comorbidities, but
are very different with regard to
readmission risk. Additionally,
concerns about attribution, given the
mix of providers these patients have
received services from during the risk
period, argues for the appropriateness of
excluding these patients. Lastly,
patients with multiple PAC stays do not
cluster in a small group of facilities, so
no facilities are disproportionately
impacted by these exclusions.
Comment: One commenter strongly
disagreed with the SNFRM’s exclusion
criteria where the patient had one or
more intervening admissions to an IRF
which occurred either prior to the
proximal hospital discharge and SNF
admission or after the SNF discharge
but before the readmission. The
commenter stated that the criteria
would not take into account medically
complex patients who may be
readmitted to the hospital for issues
treated as comorbidities. The
commenter stated that admission to an
IRF should be considered as a proximal
hospitalization.
Response: With regard to considering
an IRF stay as a proximal
hospitalization, we would like to clarify
that this measure was developed to
harmonize with other hospital
readmission measures which do not
consider post-acute care settings, like
IRFs, as proximal hospitalizations. We
have previously adopted a hospital
readmission measure for the IRF QRP
and have adopted the NQF-endorsed
version of the All-Cause Unplanned
Readmission Measure for 30 Days Post
Discharge from an IRF (NQF #2502) for
the IRF QRP. Although IRFs are licensed
as hospitals, we include them in the
PAC continuum of care and as such,
have proposed NQF #2502 to account
for readmissions following discharge
from the IRF setting.
Comment: One commenter suggested
that we exclude ventilator-dependent
residents from the readmission measure
when those patients’ prior proximal
hospitalization required being placed on
a ventilator for the first time. The
commenter noted that these patients
require frequent rehospitalizations as
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46417
part of the adjustment to ventilator
dependency.
Response: This measure of all-cause
unplanned hospital readmission
measures was harmonized with
measures adopted in other inpatient and
post-acute care programs. Consistent
with these other measures, we do not
exclude these types of patients. Rather,
the measure is designed to take into
account a variety of patient-level risk
factors through risk adjustment,
including principal diagnoses or
comorbidities that require use of
mechanical ventilation.
Comment: One commenter supported
our proposal to exclude from the
measure those patients whose prior
proximal hospitalization was for
medical treatment of cancer, and
encouraged us to examine whether other
populations should be excluded from
the measure as well.
Response: The rationale for excluding
from the measure patients whose prior
proximal hospitalization was for
medical treatment of cancer is that these
patients with these admissions have a
very different mortality and readmission
risk from the rest of the Medicare
population, and outcomes for these
admissions do not correlate well with
outcomes for other patients, as
determined in the development of the
Hospital-Wide Readmission (HWR)
measure (NQF #1789). Further detail
and relevant analyses supporting this
exclusion criterion are available in the
SNFRM Technical Report, section 2.3.1.
In the development of the HWR and
SNFRM measures, we have not
identified additional patient
populations or medical conditions
whose post-discharge trajectory of
readmissions was not consistent with
other patient groups such that they
would require exclusion from the
measure as well.
Comment: One commenter suggested
that we include planned readmissions
in the denominator but exclude them
from the numerator of the SNFRM. The
commenter noted that the way planned
readmissions are counted is not clear in
the rule. In one section, commenter
noted, the rule stated that they are
excluded; in another, it states that they
are included in the denominator but
excluded from the numerator.
Response: We would like to clarify
that the measure includes planned
readmissions in the denominator but
excludes them from the numerator. This
is consistent with how planned
readmissions are treated in in the
Hospital-Wide All-Cause Unplanned
Readmission Measure (HWR), upon
which this measure is based.
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(4) Eligible Readmissions
An eligible SNF admission is
considered to be in the 30-day risk
window from the date of discharge from
the proximal acute hospitalization until:
(1) The 30-day period ends; or (2) the
patient is readmitted to an IPPS or CAH.
If the readmission is unplanned, it is
counted as a readmission in the
numerator of the measure. If the
readmission is planned, the readmission
is not counted in the numerator of the
measure. The occurrence of a planned
readmission ends further tracking for
readmissions in the 30-day period.
We did not receive any comments on
the specific topic of eligible
readmissions. However, we addressed
comments on exclusions from the
measure above.
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(5) Risk Adjustment
Readmission rates are risk-adjusted
for patient case-mix characteristics,
independent of quality. The risk
adjustment modeling estimates the
effects of patient characteristics,
comorbidities, and select health status
variables on the probability of
readmission. More specifically, the riskadjustment model for SNFs accounts for
demographic characteristics (age and
sex), principal diagnosis during the
prior proximal hospitalization,
comorbidities based on the secondary
medical diagnoses listed on the patient’s
prior proximal hospital claim and
diagnoses from prior hospitalizations
that occurred in the previous 365 days,
length of stay during the patient’s prior
proximal hospitalization, length of stay
in the ICU, body system specific
surgical indicators, ESRD status,
whether the patient was disabled, and
the number of prior hospitalizations in
the previous 365 days.
A discussion of the general comments
that we received on the SNFRM risk
adjustment, and our responses to those
comments, appears below.
Comment: Some commenters urged us
to adjust the proposed readmission
measure for sociodemographic factors
before the SNF VBP Program is
implemented in FY 2019. Commenters
stated that factors outside the control of
the hospital, such as availability of
primary care, mental health services,
access to medications and appropriate
food, may significantly influence the
likelihood of a patient’s health
improving after hospital discharge and
whether a readmission may be
necessary. Commenters suggested that
we consider using proxy data on
sociodemographic status, such as
census-derived data on income and
education level, and claims data on the
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proportion of patients dually eligible for
Medicare and Medicaid, to adjust the
SNFRM.
One commenter stated that we should
submit the SNFRM to NQF under its
pilot program for socioeconomic risk
adjustment evaluation. The commenter
stated that many SNFs provide care to
the most vulnerable residents of their
communities and that those patients
present greater challenges in
maintaining optimal medical and
functional outcomes, including greater
risk for readmission.
Another commenter stated that the
SNFRM, and any other measures used
in the VBP program, should be
appropriately risk adjusted for the
population served. The commenter
stated that there is significant variation
in size, patient populations, and scope
of service that are not fully accounted
for by current risk adjustments. The
commenter also stated that readmission
predictors are more highly linked to
functional needs and family/caregiver
support resources, neither of which are
included in risk adjustment.
Response: While we appreciate these
comments and the importance of the
role that sociodemographic status plays
in the care of patients, we continue to
have concerns about holding providers
to different standards for the outcomes
of their patients of low
sociodemographic status because we do
not want to mask potential disparities or
minimize incentives to improve the
outcomes of disadvantaged populations.
We routinely monitor the impact of
sociodemographic status on facilities’
results on our measures.
NQF is currently undertaking a 2-year
trial period in which new measures and
measures undergoing maintenance
review will be assessed to determine if
risk-adjusting for sociodemographic
factors is appropriate for each measure.
For 2 years, NQF will conduct a trial of
a temporary policy change that will
allow inclusion of sociodemographic
factors in the risk-adjustment approach
for some performance measures. At the
conclusion of the trial, NQF will
determine whether to make this policy
change permanent. Measure developers
must submit information such as
analyses and interpretations as well as
performance scores with and without
sociodemographic factors in the risk
adjustment model.
Furthermore, the Office of the
Assistant Secretary for Planning and
Evaluation (ASPE) is conducting
research to examine the impact of
socioeconomic status on quality
measures, resource use, and other
measures under the Medicare program
as directed by the IMPACT Act. We will
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closely examine the findings of these
reports and related Secretarial
recommendations and consider how
they apply to our quality programs at
such time as they are available.
Comment: One commenter requested
that residents identified as residing in a
designated sub-acute unit within a SNF
be considered under the ‘‘other health
status’’ variable for risk adjustment.
Response: We undertake annual
maintenance of our quality measures.
We will consider this suggestion
through this process. We thank the
commenters for their contribution.
Comment: One commenter noted that
certain SNFs specialize in serving
certain patient populations that are
associated with higher rates of
hospitalization, and stated that our risk
adjustment model should not
inadvertently penalize SNFs that offer
these programs.
Response: We believe that the risk
adjustment model that we have
proposed for the SNFRM will ensure
that SNFs serving more complex patient
populations will not be penalized
inadvertently under the SNF VBP
Program.
Comment: One commenter stated that
we should consider adjusting the
SNFRM using HCCs based on hospital
and outpatient claims during the prior
year rather than the number of prior
hospital stays for a facility. The
commenter suggested that HCCs are
more likely to capture the full risk of a
patient’s comorbidities than secondary
diagnoses coded during the immediately
preceding hospital stay.
Response: To clarify, we note that this
measure uses for risk adjustment the
HCCs based on hospital claims from the
prior year in addition to secondary
diagnoses coded during the immediately
preceding hospital stay. Consistent with
other hospital readmission measures,
this measure captures HCCs based only
on inpatient claims and does not
include outpatient claims.
(6) Measurement Period
The SNFRM utilizes 1 year of data to
calculate the measure rate. Given that
there are more than 2 million Medicare
FFS SNF admissions per year in more
than 15,000 SNFs, 1 year of data is
sufficient to calculate this measure with
a model in which the risk adjusters have
sufficient sample size to have good
precision. The relevant reliability
testing may be found in the SNFRM
Technical Report.
We sought public comments on the
SNFRM’s measurement period, and
have responded to them in the ‘‘FY 2019
Performance Period and Baseline Period
Considerations’’ section below.
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(7) Stakeholder/MAP Input
Our measure development contractor
convened a TEP which provided input
on the technical specifications of this
quality measure. The TEP was
supportive of the design of this measure.
We also solicited stakeholder feedback
on the development of this measure
through a public comment process from
July 15th to 29th, 2013. In December
2014, the NQF endorsed the SNF 30-Day
All-Cause Readmission Measure (NQF
#2510).
We also considered input from the
Measures Application Partnership
(MAP) when selecting measures under
the CMS SNF VBP Program. The MAP
is composed of multi-stakeholder
groups convened by the NQF, our
current contractor under section 1890(a)
of the Act. The MAP has noted the need
for care transition measures in PAC/
Long Term Care (LTC) performance
measurement programs and stated that
setting-specific admission and
readmission measures under
consideration would address this
need.14 We included the SNFRM on the
December 1, 2014 List of Measures
under Consideration (MUC List), and
the MAP supported the measure. A
spreadsheet of MAP’s 2015 Final
Recommendations is available at NQF’s
Web site at https://www.quality
forum.org/WorkArea/linkit.aspx?Link
Identifier=id&ItemID=78711.
We sought public comments on our
proposal to adopt the SNF 30-Day AllCause Readmission Measure (SNFRM)
(NQF #2510) for use in the SNF VBP
Program, and our responses appear in
subsections i. through vii. above, as well
as in subsection viii. below.
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(8) Feedback Reports to SNFs
Section 1888(g)(5) of the Act requires
that beginning October 1, 2016, SNFs be
provided quarterly confidential
feedback reports on their performance
on measures specified under sections
1888(g)(1) or (2) of the Act.
We intended to address this topic in
future rulemaking. However, we
requested public comment on the best
means by which to communicate these
reports to SNFs. For example, we could
consider providing confidential,
downloadable feedback reports to SNFs
through a secure portal, such as
QualityNet. We also invited comment
on the level of detail that would be most
helpful to SNFs in understanding their
14 National Quality Forum. Measure Applications
Partnership Pre-Rulemaking Report: 2013
Recommendations of Measures Under
Consideration by HHS: February 2013. Available at
https://www.qualityforum.org/WorkArea/
linkit.aspx?LinkIdentifier=id&ItemID=72738.
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performance on the new quality
measures. The comments we received
on these topics, with their responses,
appear below.
Comment: One commenter supported
our suggested plan to provide SNFRM
feedback reports to SNFs via a secure
portal such as QualityNet. The
commenter suggested that we provide
full details on how their scores were
determined, including data on
readmitted beneficiaries and details on
SNFs’ rankings, so that facilities may
validate their performance and perform
quality improvement efforts.
Response: We will provide
information to providers on facilities’
scores on this measure. As discussed
further below, we intend to consider
what information should be included in
SNFRM feedback reports in the future,
and we will further consider the
commenter’s feedback when we develop
our proposals on that topic. However,
while we may provide information
pertaining to a patient’s readmission
episode, we cannot interpret such
determinations and readmission
rationales, or provide post-discharge
information. As part of their quality
improvement and care coordination
efforts, SNFs are encouraged to monitor
hospital readmissions and follow up
with patients post discharge. Therefore,
although we will not be providing
specific information at the patient level
in the feedback reports, we believe that
SNFs will monitor their overall hospital
readmission rates and assess their
performance.
Comment: One commenter noted that
the quarterly feedback reports required
under the Program will use claims data,
but that these data may not be accurate
if SNFs do not submit their claims
timely. The commenter noted that SNFs
have up to 12 months to submit claims,
which may affect performance
measurement.
Response: We intend to monitor
SNFRM performance to ensure that
unintended consequences related to the
time facilities have to submit or
resubmit claims do not result.
After consideration of the public
comments that we have received, we are
finalizing our proposal to specify the
SNF 30-Day All-Cause Readmission
Measure (SNFRM) (NQF #2510) and to
adopt the measure for the SNF VBP as
the SNF all-cause, all-condition hospital
readmission measure under section
1888(g)(1) of the Act as proposed.
d. Performance Standards
(1) Background
Section 1888(h)(3) of the Act requires
the Secretary to establish performance
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46419
standards for the SNF VBP Program.
The performance standards must
include levels of achievement and
improvement, and must be established
and announced not later than 60 days
prior to the beginning of the
performance period for the FY involved.
To assist us in developing our proposals
to establish performance standards for
the SNF VBP program, we reviewed a
number of innovative health care
programs and demonstration projects,
both public and private, to discover if
any could serve as a prototype for the
SNF VBP program. One methodology of
important note that provides us an
analogous framework for
implementation of performance
standards is the Performance
Assessment Model, implemented for our
Hospital VBP program. We also
reviewed the Hospital Acquired
Conditions Reduction Program, as well
as the Hospital Readmissions Reduction
Program and the End-Stage Renal
Disease Quality Incentive Program
(ESRD QIP).
We invited comment on several
potential approaches for calculating
performance standards under the SNF
VBP Program. The comments we
received on this topic, with their
responses, appear below after
discussion of these potential
approaches.
(a) Hospital Value-Based Purchasing
Program
Under the Hospital VBP Program, a
hospital’s Total Performance Score is
determined by aggregating and
weighting domain scores, which are
calculated based on hospital
performance on measures within each
domain. The domain scores are then
weighted to calculate a TPS that ranges
between 0 and 100 points. At this time,
we do not anticipate proposing to adopt
quality measurement domains akin to
other CMS quality programs under the
SNF VBP Program due to fact that this
program is based on only one measure.
To calculate HVBP measure scores,
hospital performance on specified
quality measures is compared to
performance standards established by
the Secretary. These performance
standards include levels of achievement
and improvement and enable us to
award between 0 and 10 points to each
hospital based on its performance on
each measure during the performance
period. An achievement threshold,
generally defined as the median of all
hospital performance on most measures
during a specified baseline period, is the
minimum level of performance required
to receive achievement points. The
benchmark, generally defined as the
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mean of the top decile of all hospital
performance on a measure during the
baseline period, is the performance level
required for receiving the maximum
number of points on a given measure.
The Program also establishes an
improvement threshold for each
measure, set at each individual
hospital’s performance on the measure
during the baseline period, to award
points for improvement over time.
We believe that the Hospital VBP
Program’s performance standards
methodology is a well-understood
methodology under which health care
providers and suppliers can be
rewarded both for providing highquality care and for improving their
performance over time. The statutory
authority for the Hospital VBP Program
is structured similarly to the statutory
authority for the SNF VBP Program, and
we are considering adoption of a similar
methodology for establishing
performance standards under the SNF
VBP Program. We also seek to align our
pay-for-performance and QRPs as much
as possible. Specifically, we could
consider adopting performance
standards based on all SNF performance
during the baseline period on the
measure specified under section
1888(g)(1) or (2) of the Act in the form
of the achievement threshold—median
of all SNF performance during a
baseline period—and the benchmark—
mean of the top decile of all SNF
performance during a baseline period.
We could then consider awarding points
along a continuum relative to those
performance levels.
(b) Hospital-Acquired Conditions
Reduction Program
We also considered whether we
should adopt any components of the
scoring methodology that we have
finalized for the HAC Reduction
Program under the SNF VBP Program.
The HAC Reduction Program requires
the Secretary to reduce eligible
hospitals’ Medicare payments to 99
percent of what would otherwise have
been paid for discharges when hospitals
rank in the worst performing quartile for
risk-adjusted HAC quality measures.
These quality measures comprise efforts
to promote quality of care by reducing
the number of HACs in the acute
inpatient hospital setting.
We determine a hospital’s Total HAC
Score by first assigning each hospital a
score of between 1 and 10 for each
measure based on the hospital’s relative
performance ranking in 10 groups (or
deciles) for that measure. Second, the
measure score is used to calculate the
domain score. We discuss other details
of the HAC Reduction Program’s scoring
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methodology in further detail in this
section.
Although the HACRP statutory
authority is not structured the same as
the SNF VBP statutory authority, we
view the HACRP’s use of decile-based
performance standards as one
conceptual possibility for constructing
performance standards under the SNF
VBP Program. Specifically, we could
consider setting performance standards
based on SNFs’ ranked performance on
the measures specified under sections
1888(g)(1) or (2) of the Act during the
performance period. We could divide
SNFs’ performance on the measures into
deciles and award between 1 and 10
points to all SNFs within each decile.
While this type of performance
standards calculation would measure
and reward achievement, we are
concerned that it would not incorporate
improvement, and we invited comment
on the best means by which we could
include improvement in this type of
calculation.
(c) Hospital Readmissions Reduction
Program (HRRP)
We also considered aspects of the
Hospital Readmissions Reduction
Program (HRRP) for adaptation under
the SNF VBP Program. HRRP reduces
Medicare payments to hospitals with a
higher number of readmissions for
applicable conditions over a specified
time period.
Hospital readmissions are defined as
Medicare patients who are readmitted to
the same or another hospital within 30
days of a discharge from the same or
another hospital, which includes shortterm inpatient acute care hospitals. The
initial hospital inpatient admission (the
discharge from which starts the 30-day
potential penalty clock) is termed the
index admission. The hospital inpatient
readmission (which can be used to
determine application of a penalty if the
readmission occurs within 30 days of
the index inpatient admission stay) can
be for any cause, that is, it does not have
to be for the same cause as the index
admission.
Using historical data, we determine
whether eligible IPPS hospitals have
readmission rates that are higher than
expected, given the hospital’s case mix,
while accounting for the patient risk
factors, including age, and chronic
medical conditions identified from
inpatient and outpatient claims for the
12 months prior to the hospitalization.
A hospital’s excess readmission ratio for
each condition is a measure of a
hospital’s readmission performance
compared to the national average for the
hospital’s set of patients with that
applicable condition. If the hospital’s
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actual readmission rate, based on the
hospital’s actual performance, for the
year is greater than its CMS-expected
readmission rate, the hospital incurs a
penalty up to the maximum cap. If a
hospital performs better than an average
hospital that admitted similar patients,
the hospital will not be subjected to a
payment reduction. If a hospital
performs worse than average (below a
1.000 score), the poorer performance
triggers a payment reduction. For FY
2013, the reduction was capped at 1
percent, for FY 2014 at 2 percent, and
at 3 percent for FY 2015 and for
subsequent years.
We view the Hospital Readmissions
Reduction Program as a potential model
for the SNF VBP Program because that
program does not weight scores based
on domains. That is, under the HRRP,
hospitals’ risk-adjusted readmissions
ratios form the basis for Medicare
payment adjustments. Under SNF VBP
(and as discussed further in this
section), the Program’s statute requires
us to select only one measure to form
the basis for the SNF Performance
Score. We believe that this conceptual
similarity stands distinct from certain
other CMS quality programs that
incorporate quality measurement
domains and domain weighting into the
scoring calculations. However, the
HRRP sets an effective performance
standard based on the average
readmissions adjustment factor of 1.000.
We invited comment on whether we
should adopt a similar form of
performance standard under the SNF
VBP Program.
This performance standard could take
the form of the median or mean
performance on the specified quality
measure during the performance period.
However, we believe we would also
need to consider more granular
delineations in SNF scoring to ensure an
appropriate distribution of value-based
incentive payments under the Program,
and we invited comment on what
additional policies we should consider
adopting in this topic area.
(d) End-Stage Renal Disease Quality
Incentive Program (ESRD QIP)
The ESRD QIP is authorized by
section 1881(h) of the Act. The program
promotes patient health by providing a
financial incentive for renal dialysis
facilities to deliver high-quality care to
their patients.
Section 1881(h)(3)(A)(i) of the Act
requires the Secretary to develop a
methodology for assessing the total
performance of each provider and
facility based on performance standards.
For each clinical measure adopted
under the ESRD QIP, we assess
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performance on both achievement and
improvement. For the achievement
score, facility performance on a measure
during a performance period is
compared against national facility
performance on that measure during a
specified baseline period. To calculate
the improvement score, we compare a
facility’s performance during the
performance period to its performance
during a specified baseline period. In
determining a clinical measure score for
each measure, we take the higher of the
improvement or achievement score.
For each reporting measure, we assess
performance based on whether the
facility completed the reporting for that
measure as specified. If a facility reports
data according to the specifications we
have adopted, then the facility earns the
maximum number of points on the
measure. If the facility partially reports
data according to the specifications we
have adopted, the hospital earns some
points on the measure, but less than the
maximum.
We believe that the ESRD QIP
performance standards methodology is a
well-understood methodology under
which health care providers and
suppliers can be rewarded both for
providing high-quality care and for
improving their performance over time.
The scoring methodology rewards
achievement and improvement, and is
generally aligned with other pay-forperformance and QRPs. Like the
Hospital VBP Program statutory
language, the ESRD QIP statutory
language is structured similar to the
SNF VBP Program statutory language,
and we are considering adoption of a
similar methodology for calculating
performance standards under the SNF
VBP Program. Specifically, we could
consider adopting performance
standards based on all SNF performance
during the baseline period on the
measure specified under sections
1888(g)(1) or (2) of the Act in the forms
of the achievement threshold—median
of all SNF performance—and the
benchmark—mean of the top decile of
all SNF performance. We could then
consider awarding points for those
performance levels.
A discussion of the comments that we
received on potential approaches to
calculating performance standards, and
our responses to those comments,
appears below.
Comment: One commenter suggested
that we reconsider using the ‘‘higher of’’
achievement and improvement
requirement when determining the
performance score and we should focus
the SNF VBP Program on having all
providers furnish high quality of care.
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Response: We do not believe we have
the authority to reconsider using the
‘‘higher of’’ achievement and
improvement requirement given the
statutory requirement in section
1888(h)(3)(B) of the Act, which requires
us to adopt performance standards that
include levels of achievement and
improvement, and further directs us to
use the higher of either improvement or
achievement in calculating the SNF
performance score under paragraph (4).
Comment: Commenters urged us to
establish performance standards prior to
the beginning of the performance
period, as we do in the Hospital VBP
Program. Commenters stated that this
policy enables providers to understand
in advance what level of performance
they must reach under the Program.
Response: We intend to establish and
announce performance standards in
advance of the performance period in
accordance with the requirement in
section 1888(h)(3)(C) of the Act.
We will consider these comments
further in future rulemaking.
(2) Measuring Improvement
We are considering several
methodologies for improvement scoring
under the SNF VBP Program, and we
invited public comments on these
options or others that we should
consider as we develop our SNF VBP
Program policies for future rulemaking.
Section 1888(h)(4)(B) of the Act
specifically requires us to construct a
ranking of SNF performance scores.
While we view such a ranking system as
fairly straightforward when based on
achievement scoring—for example,
ranking SNFs based on their
performance on a measure during the
performance period could be achieved
by ordering SNF performance rates on
the measure specified for the Program
year—we are considering several
approaches for including improvement
in the SNF scoring methodology
because we are limited to one measure
for each SNF Program year. These
approaches include:
• Improvement points, awarded using
a similar methodology as the one we use
to award improvement points in the
Hospital VBP Program.
• Measure rate increases, in which a
SNF’s performance rate on a measure
would be increased as a result of its
improvement over time.
• Ranking increases, in which a
SNF’s ranking relative to other SNFs
would be increased as a result of
improvement.
• Performance score increases, in
which a SNF’s performance score would
be increased as a result of improvement.
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We discuss each of these options in
further detail in the FY 2016 SNF PPS
proposed rule (80 FR 22063 through
22064).
The comments we received on this
topic, along with their responses, appear
below.
Comment: Commenters stated that we
should not adjust SNFs’ measure rates
directly to reward improvement,
cautioning that making those types of
adjustments could make valid
comparisons of SNF performance more
difficult.
Response: We thank the commenters
for this feedback.
Comment: Some commenters did not
believe that improvement measurement
should apply to providers in the top
quartile of SNFRM performance.
Commenters supported recognizing
improvement efforts, but believed that
the top quartile should recognize top
performers.
Response: We thank the commenters
for this feedback, and we will take it
into account as we develop our
performance standards policy proposals
in the future.
Comment: One commenter suggested
that we not adopt an achievement
threshold under the SNF VBP Program
to ensure that all SNFs may qualify for
points. The commenter also suggested
that we place equal emphasis on
improvement under the program, and
noted that the Hospital VBP Program
separately calculates achievement and
improvement and awards the higher of
the two to participating hospitals.
Response: We thank the commenter
for this feedback, and we will take it
into account as we develop our
performance standards policy proposals
in the future.
Comment: One commenter urged us
not to set an absolute level of
performance to which SNFs would have
to aspire to receive points. The
commenter stated that adopting
performance standards in this manner
would disincentivize improvement, as
some SNFs would be unable to receive
value-based incentive payments.
Response: We thank the commenter
for this feedback, and will consider it in
the future.
Comment: One commenter requested
that we solicit public comments on
performance standards, performance
scoring, and the exchange function after
releasing detailed analysis of the various
options, as well as performance data on
the SNFRM.
Response: We thank the commenter
for this feedback. We intend to provide
as much information as possible on our
proposals for this Program in the future.
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Comment: One commenter
recommended that we award points to
SNFs for achievement and
improvement, but ensure that lowperforming SNFs that improve are not
ranked higher than high-performing
SNFs.
Response: We thank the commenter
for this feedback and will take it into
account when developing our proposals
in the future.
We will consider these comments
further in future rulemaking.
e. FY 2019 Performance Period and
Baseline Period Considerations
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(1) Performance Period
We intended to specify a performance
period for a payment year close to the
payment year’s start date. We strive to
link performance furnished by SNFs as
closely as possible to the payment year
to ensure clear connections between
quality measurement and value-based
payment. We also strive to measure
performance using a sufficiently reliable
population of patients that broadly
represent the total care provided by
SNFs. As such, we anticipate that our
annual performance period end date
must provide sufficient time for SNFs to
submit claims for the patients included
in our measure population. In other
programs, such as HRRP and the
Hospital Inpatient Quality Reporting
Program (HIQR), this time lag between
care delivered to patients who are
included in the readmission measures
and application of a payment
consequence linked to reporting or
performance on those measures has
historically been close to 1 year. We also
recognize that other factors contribute to
this time lag, including the processing
time we need to calculate measure rates
using multiple sources of claims needed
for statistical modeling, time for
providers to review their measure rates
and included patients, and processing
time we need to determine whether a
payment adjustment needs to be made
to a provider’s reimbursement rate
under the applicable PPS based on its
reporting or performance on measures.
For the FY 2019 SNF VBP Program’s
performance period, we are also
considering the necessary timeline we
need to complete measure scoring to
announce the net result of the Program’s
adjustments to Medicare payments not
later than 60 days prior to the FY, in
accordance with section 1888(h)(7) of
the Act. We are also considering the
number of SNF stays typically covered
by Medicare each year. As discussed
previously, Medicare typically covers
more than 2 million Medicare Part A
stays per year in more than 15,000
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SNFs. Therefore, we believe that 1 year
of SNFRM data is sufficient to ensure
that the measure rates are statistically
reliable.
We intended to propose a
performance period for the FY 2019
SNF VBP Program in future rulemaking.
We invited public comment on the most
appropriate performance period length.
The comments we received on this
topic, with their responses, appear
below.
Comment: Commenters supported a
one-year performance period, and
suggested that we also consider
establishing a minimum annual case
count which data from multiple years
could be pooled to create more
statistically-reliable measure scores.
Response: We thank the commenters
for their support. We will consider
whether we should establish a
minimum annual case count for the
SNFRM in future rulemaking.
We will consider these comments
further in future rulemaking.
(2) Baseline Period
As described previously, in other
Medicare quality programs such as the
Hospital VBP Program and the ESRD
Quality Incentive Program, we generally
adopt a baseline period that occurs prior
to the performance period for a FY to
measure improvement and establish
performance standards.
We view the SNF VBP Program as
necessitating a similarly-adopted
baseline period for each FY to measure
improvement (as required by section
1888(h)(3)(B) of the Act) and to enable
us to calculate performance standards
that we must establish and announce
prior to the performance period (as
required by section 1888(h)(3)(A) of the
Act). As with the Hospital VBP Program,
we intend to adopt baseline periods that
are as close as possible in duration as
the performance period specified for a
FY. However, we may occasionally need
to adopt a baseline period that is shorter
than the performance period to meet
operational timelines. We also intended
to adopt baseline periods that are
seasonally aligned with the performance
periods to avoid any effects on quality
measurement that may result from
tracking SNF performance during
different times of the calendar year.
We stated our intent to propose a
baseline period for purposes of
calculating performance standards and
measuring improvement in future
rulemaking. We invited public comment
on the most appropriate baseline period
for the FY 2019 Program, including
what considerations we should take into
account when developing this policy for
future rulemaking. The comments we
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received on this topic, with their
responses, appear below.
Comment: Commenters supported our
proposal to adopt a 12-month baseline
period for purposes of quality
measurement. Some commenters
suggested that we test longer time
periods, however, to see whether more
time improves the measure’s variation.
Commenters further suggested that we
align the baseline and performance
periods under the SNF VBP Program to
the calendar year.
Response: We thank the commenters
for their support. We will consider
testing longer time periods in the future.
We will consider these comments
further in future rulemaking.
f. SNF Performance Scoring
(1) Considerations
As with our performance standards
policy considerations described above,
we considered how other Medicare
quality programs score eligible facilities.
Specifically, we considered how the
Hospital VBP Program and the HospitalAcquired Conditions Reduction
Program score eligible hospitals. We
discussed the Hospital Readmissions
Reduction Program’s scoring above in
relation to performance standards.
(a) Hospital Value-Based Purchasing
A Hospital VBP domain score is
calculated by combining the measure
scores within that domain, weighting
each measure equally. The domain score
reflects the number of points the
hospital has earned based on its
performance on the measures within
that domain for which it is eligible to
receive a score. After summing the
weighted domain scores, the TPS is
translated using a linear exchange
function into the percentage multiplier
to be applied to each Medicare
discharge claim submitted by the
hospital during the applicable FY. (We
discuss the Exchange Function in
further detail below).
Unlike the Hospital VBP Program, the
SNF VBP program focuses on a single
readmission measure, one that will be
replaced by a single resource use
measure as soon as is practicable. As
described above, we do not anticipate
adopting quality measure domains akin
to other CMS quality programs under
the SNF VBP Program. We therefore
invited comment on how, if at all, we
should adapt the HVBP Program’s
scoring methodology to accommodate
both the smaller number of measures
and the ranking required under the SNF
VBP Program. We responded to
comments on this topic below.
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(b) Hospital-Acquired Conditions
Reduction Program
The Hospital-Acquired Conditions
(HAC) Reduction Program scores
measures that have been categorized
into domains, in a manner that is
similar to the HVBP Program’s domain
structure. For Domain 1, the points
awarded to the single assigned measure
yield the Domain 1 score, since Domain
1 only contains one measure. For
Domain 2, the points awarded for the
domain measures are averaged to yield
a Domain 2 score. A hospital’s Total
HAC Score is determined by the sum of
weighted Domain 1 and Domain 2
scores. Higher scores indicate worse
performance relative to the performance
of all other eligible hospitals. Hospitals
with a Total HAC Score above the 75th
percentile of the Total HAC Score
distribution are subject to a payment
reduction.
Unlike the Hospital VBP program,
referenced above, there is no
requirement in the HAC Reduction
Program that measures or performance
standards must incorporate
improvement and achievement scores.
As with the HVBP Program above, we
invited public comments on the extent
to which, if at all, we should adopt
components of the HAC Reduction
Program’s scoring methodology for
purposes of the SNF VBP Program. We
specifically invited comments on
whether we should set an absolute level
of performance that must be reached to
receive a positive SNF value-based
incentive payment. We responded to
comments on this topic below.
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(c) Other Considerations
We stated our intention to consider
several additional factors when
developing the performance scoring
methodology. We believe that it is
important to ensure that the
performance scoring methodology is
straightforward and transparent to
SNFs, patients, and other stakeholders.
SNFs must be able to clearly understand
performance scoring methods and
performance expectations to maximize
their quality improvement efforts. The
public must understand the scoring
methodology to make the best use of the
publicly reported information when
choosing a SNF. We also believe that
scoring methodologies for all Medicare
VBP programs should be aligned as
appropriate given their specific
statutory requirements. This alignment
will facilitate the public’s
understanding of quality information
disseminated in these programs and
foster more informed consumer decision
making about health care. We believe
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that differences in performance scores
must reflect true differences in
performance. To ensure that these
beliefs are appropriately reflected in the
SNF VBP Program, we stated our
intention to assess the quantitative
characteristics of the measures specified
under sections 1888(g)(1) and (2) of the
Act, including the current state of
measure development, to ensure an
appropriate distribution of value-based
incentive payments as required by the
SNF VBP statute.
We invited public comment on what
other considerations we should take
into account when developing our
proposed scoring methodology for the
SNF VBP Program in future rulemaking.
The comments we received on this
topic, as well as all other comments on
considerations we should take into
account when developing the SNF VBP
Program’s scoring methodology, along
with their responses, appear below.
Comment: Some commenters agreed
that adapting the Hospital VBP
Program’s scoring methodology is
advantageous for the SNF VBP Program
because it is well-understood and
tested. Other commenters noted that we
have substantial experience with this
type of approach and stated that this
approach provides the strongest
incentive for all SNFs to improve their
performance.
Response: We thank the commenters
for their support and will take this
feedback into account when developing
our proposals in the future.
Comment: One commenter provided
general suggestions for us as we develop
the SNF VBP Program’s scoring
methodology, including the beliefs that
the methodology should be easy to
understand and that we should provide
education to SNFs in the first years of
the program. The commenter also
expressed support for public reporting
of SNF performance scores and quality
measure performance, and suggested
that we provide regular feedback to
SNFs prior to publication.
Response: We thank the commenters
for the feedback and support. We will
take these recommendations into
account in future rulemaking.
Comment: One commenter outlined
several principles for our consideration
while designing the SNF VBP Program,
including aligning incentives, involving
stakeholders, focusing on improving
quality instead of cost-cutting,
providing rewards that motivate change,
implementing the program
incrementally, rewarding both high
levels of performance and substantial
improvements, using measures
developed in an open, consensus-based
manner, including evidence-based
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measures, and designing the program to
avoid perpetuating care disparities.
Response: We thank the commenter
for the feedback and will take it into
account when developing our proposals
in the future.
Comment: One commenter urged us
to continue engaging stakeholders in
discussions on the SNF VBP Program’s
design, particularly given the
commenter’s opinion that the program
is more characteristic of a penalty
program than an incentive program.
Response: We disagree with the
commenter’s characterization of the
Program as a ‘‘penalty program.’’ The
SNF VBP Program is designed to reward
SNFs based on their quality
performance, whether accomplished
through achievement or improvement
over time.
Comment: One commenter urged us
to consider the variations in the types
and intensity of SNF-based care when
developing performance standards and
the ranking for the SNF VBP Program,
stating that we should distinguish
between primarily short-term,
transitional care and medically
complex, longer-term patients. The
commenter suggested that we consider
adopting a similar policy to the longterm care hospital interrupted stay
policy for the SNF PPS to ensure that
facilities are not provided with
incentives to withhold medically
necessarily care for fear of loss of
significant revenue.
Response: The SNFRM, which was
endorsed by the NQF, has been risk
adjusted for case-mix to account for
differences in patient populations. The
goal of risk adjustment is to account for
these differences so that providers who
treat sicker or more vulnerable patient
populations are not unnecessarily
penalized. The current measure
accounts for all of the factors proposed
in the comment above, including the
following: principal diagnosis from the
Medicare claim corresponding to the
prior proximal hospitalization as
categorized by AHRQ’s CCS groupings,
length of stay during the patient’s prior
proximal hospitalization, length of stay
in the ICU, ESRD status, whether the
patient was disabled, the number of
prior hospitalizations in the previous
365 days, system-specific surgical
indicators, individual comorbidities as
grouped by CMS’s HCC or other
comorbidity indices, and a variable
counting the number of comorbidities if
the patient had more than two HCCs.
However, as discussed above, this
measure does not currently adjust for
beneficiaries that are dually eligible in
Medicare and Medicaid. Based on the
results of the NQF trial period for risk-
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adjustment for socioeconomic status, as
well as work being conducted on this
issue by ASPE, the measure
specifications may be revised to include
additional risk adjusters in the future
related to socioeconomic status or
sociodemographics.
Comment: One commenter suggested
that we conduct data analyses to
determine whether different measures
or scoring should be applied to hospitalbased and freestanding SNFs.
Response: We thank the commenter
for this feedback and will consider
whether this type of adjustment is
appropriate in the future.
Comment: One commenter suggested
that we modify the ESRD QIP’s scoring
methodology for adoption under the
SNF VBP Program. The commenter
stated that the other models described
in the proposed rule do not meet the
Program’s statutory requirements.
Response: We thank the commenter
for this feedback. We intend to ensure
that any proposed scoring methodology
under the SNF VBP Program complies
fully with applicable statutory
requirements.
We will consider these comments
further in future rulemaking.
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(2) Notification Procedures
As described above, we stated our
intention to address the topic of
quarterly feedback reports to SNFs
related to measures specified under
sections 1888(g)(1) and (2) of the Act in
future rulemaking. We also stated that
we intend to address how to notify
SNFs of the adjustments to their PPS
payments based on their performance
scores and ranking under the SNF VBP
Program, in accordance with the
requirement in section 1888(h)(7) of the
Act, in future rulemaking.
We invited public comment on the
best means by which to so notify SNFs.
We responded to comments on this
topic below in the ‘‘SNF-Specific
Performance Information’’ subsection.
(3) Exchange Function
As described above in reference to the
Hospital VBP Program’s scoring
methodology, we use a linear exchange
function to translate a hospital’s Total
Performance Score under that Program
into the percentage multiplier to be
applied to each Medicare discharge
claim submitted by the hospital during
the applicable FY. We refer readers to
the Hospital Inpatient VBP Program
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Final Rule (76 FR 26531 through 26534)
for detailed discussion of the Hospital
VBP Program’s Exchange Function, as
well as responses to public comments
on this issue.
We believe we could consider
adopting a similar exchange function
methodology to translate SNF
performance scores into value-based
incentive payments under the SNF VBP
Program, and we invited comment on
whether we should do so. However, as
we did for the Hospital VBP Program,
we believe we would need to consider
the appropriate form and slope of the
exchange function to determine how
best to reward high performance and
encourage SNFs to improve the quality
of care provided to Medicare
beneficiaries. As illustrated in figure 1,
we could consider the following four
mathematical exchange function
options: Straight line (linear); concave
curve (cube root function); convex curve
(cube function); and S-shape (logistic
function), and we seek comment on
what form of the exchange function we
should consider implementing if we
adopt such a function under the SNF
VBP Program.
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We also invited comment on what
considerations we should take into
account when determining the
appropriate form of the exchange
function under the SNF VBP Program.
We stated our intention to consider how
such options would distribute the valuebased incentive payments among SNFs,
the potential differences between the
value-based incentive payment amounts
for SNFs that perform poorly and SNFs
that perform very well, the different
marginal incentives created by the
different exchange function slopes, and
the relative importance of having the
exchange function be as simple and
straightforward as possible. We
requested public comments on what
additional considerations, if any, we
should take into account. The comments
we received on this topic, with their
responses, appear below.
Comment: One commenter expressed
support for a linear exchange function
under the SNF VBP Program, stating
that such a function is easily understood
by providers and may encourage
practice pattern changes more easily
than a more complex function.
Commenters also noted that a linear
exchange function gives equal
importance to improvement for lowerand higher-performing SNFs, and gives
all providers an equal opportunity to
earn an incentive payment.
Response: We thank the commenter
for the feedback on this topic. We will
take these recommendations into
account in future rulemaking.
Comment: One commenter suggested
that we adopt a logistic exchange
function and ensure that top-performing
SNFs earn back more than 2 percent of
their payments from the Program.
Response: We thank the commenter
for the feedback on this topic. We will
take these recommendations into
account in future rulemaking.
We will consider these comments
further in future rulemaking.
g. SNF Value-Based Incentive Payments
Sections 1888(h)(5) and (6) of the Act
outline several requirements for valuebased incentive payments under the
SNF VBP Program, including the valuebased incentive payment percentage
that must be determined for each SNF
and the funding available for valuebased incentive payments.
We stated our intention to address
this topic in future rulemaking. A
discussion of the general comments that
we received on the SNF Value-Based
incentive payments, and our responses
to those comments, appears below.
Comment: Commenters recommended
that we distribute the maximum 70
percent of the funds withheld from
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participating SNF payments under the
SNF VBP Program to ensure that the
program offers payment for value
instead of becoming a penalty program.
Some commenters also suggested that
the remaining 30 percent of funds
withheld be used to fund SNF quality
improvement initiatives. Other
commenters requested that we explain
how the remaining 30–50 percent of
funds will be used.
Response: We thank the commenters
for this feedback. As the commenters
noted, section 1888(h)(5)(C)(ii)(III) of the
Act requires that the total amount of
value-based incentive payments under
the SNF VBP Program for all SNFs in a
fiscal year must be greater than or equal
to 50 percent, but not greater than 70
percent, of the total amount of the
reductions to the SNF PPS payments for
that fiscal year, as estimated by the
Secretary. We do not believe we have
the authority to use the balance of funds
that will remain after paying out valuebased incentive payments to SNFs
under the Program for other SNF quality
improvement initiatives. We believe
these funds are required to remain in
the Medicare Trust Fund.
We will consider these comments
further in future rulemaking.
h. SNF VBP Public Reporting
(1) SNF-Specific Performance
Information
Section 1888(h)(9)(A) of the Act
requires the Secretary to post
information on the performance of
individual SNFs under the SNF VBP
Program on the Nursing Home Compare
Web site or its successor. This
information is to include the SNF
performance score for the facility for the
applicable FY and the SNF’s ranking for
the performance period for such FY.
We stated our intention to address
this topic in future rulemaking. We
invited public comment on how we
should display this SNF-specific
performance information, whether we
should allow SNFs an opportunity to
review and correct the SNF-specific
performance information that we will
post on Nursing Home Compare, and
how such a review and correction
process should operate. The comments
we received on this topic, with their
responses, appear below.
Comment: One commenter requested
that SNFs have an opportunity to review
and correct their performance
information prior to its posting on
Nursing Home Compare. Commenters
requested that the information furnished
to SNFs for this purpose should
incorporate sufficient detail for SNFs to
validate their performance and ranking.
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The commenters also stated that any
public reporting should include
explanations of the SNFRM’s
methodology, what the measure is
intended to show, and any of its
limitations.
Response: We thank the commenters
for this feedback. We will take it into
account as we develop our policies on
posting SNF-specific information in the
future.
Comment: One commenter supported
our intention to distribute confidential
feedback reports to SNFs via a secure
portal. However, the commenter
suggested that we use QIES rather than
QualityNet, as the former is familiar to
SNFs.
Response: We thank the commenter
for this feedback, and will take it into
account in the future.
Comment: Other commenters
suggested that we use the existing
mechanism, QIES, for providing SNFs
feedback reports and access to their
quality measures as to provide quarterly
performance reports. The commenters
noted that these reports should provide
information on performance relative to
others and ranking relative to the
payment adjustment. Commenters
requested that the reports include
actual, non-adjusted measures,
predicted actual, expected rate,
standardized RR, risk adjusted rate,
actual numerator, actual denominator,
list of patients in numerator,
improvement score, achievement score,
performance score and performance
rank.
Response: We thank the commenters
for these suggestions. We will provide
details on infrastructure decisions such
as this in future rulemaking. We
interpret the comment to indicate that it
would be useful for providers to receive
from CMS readmission-related
information so that they can better
understand why a given patient was
readmitted and for care-related
improvement purposes. We support the
intent to seek information that will
drive improved quality; however, as
described above, while we may provide
information pertaining to a patient’s
readmission episode, we cannot
interpret such determinations and
readmission rationales, or provide postdischarge information. As part of their
quality improvement and care
coordination efforts, SNFs are
encouraged to monitor hospital
readmissions and follow up. Therefore,
although this measure will not provide
specific information at the patient level,
we believe that SNFs will be able to
monitor their overall hospital
readmission rates and assess their
performance.
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Comment: Commenters requested that
we make claims available to providers
and others to calculate the SNFRM
measure on an ongoing basis (for
example quarterly) such as we are doing
by providing claims data to the Bundled
Payments for Care Improvement (BPCI)
initiative participants. Commenters also
recommended that we make available
Part A claims on a much more frequent
basis (for example, quarterly) so that
organizations, vendors, and other
stakeholders can calculate the
rehospitalization rates for SNF patients
and provide additional analyses and
profiling that can help SNFs with their
quality improvement efforts such as
what is currently done with MDS data
and quality measures.
Response: We thank the commenters
for these suggestions. We will address
data availability in future rulemaking.
We will consider these comments
further in future rulemaking.
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(2) Aggregate Performance Information
Section 1888(h)(9)(B) of the Act
requires the Secretary to post aggregate
information on the SNF VBP Program
on the Nursing Home Compare Web
site, or a successor Web site, to include
the range of SNF performance scores
and the number of SNFs that received
value-based incentive payments and the
range and total amount of such valuebased incentive payments.
We stated our intention to address
this topic in future rulemaking. We
invited public comment on the most
appropriate form for posting this
aggregate information to make such
information easily understandable for
the public. The comments we received
on this topic, with their responses,
appear below.
Comment: One commenter suggested
that we combine aggregate performance
information with individual
rehospitalization performance scores
and rankings when posting SNFs’
performance information on Nursing
Home Compare. The commenter stated
that the ranking and SNF performance
score alone will be confusing because
they will combine achievement and
improvement.
Response: We thank the commenter
for this feedback, and will take it into
account in the future rulemaking.
2. Advancing Health Information
Exchange
HHS has a number of initiatives
designed to encourage and support the
adoption of health information
technology and to promote nationwide
health information exchange (HIE) to
improve health care. As discussed in the
August 2013 Statement ‘‘Principles and
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Strategies for Accelerating Health
Information Exchange’’ (available at
https://www.healthit.gov/sites/default/
files/acceleratinghieprinciples_
strategy.pdf), HHS believes that all
individuals, their families, their
healthcare and social service providers,
and payers should have consistent and
timely access to health information in a
standardized format that can be securely
exchanged between the patient,
providers, and others involved in the
individual’s care. Health information
technology (IT) that facilitates the
secure, efficient and effective sharing
and use of health-related information
when and where it is needed is an
important tool for settings across the
continuum of care, including SNFs and
NFs. While these facilities are not
eligible for the Medicare and Medicaid
EHR Incentive Programs, effective
adoption and use of health information
exchange and health IT tools will be
essential as these settings seek to
improve quality and lower costs through
initiatives such as VBP.
The Office of the National
Coordinator for Health Information
Technology (ONC) has released a
document entitled ‘‘Connecting Health
and Care for the Nation: A Shared
Nationwide Interoperability Roadmap
Draft Version 1.0 (draft Roadmap)
(available at https://www.healthit.gov/
sites/default/files/nationwideinteroperability-roadmap-draft-version1.0.pdf) which describes barriers to
interoperability across the current
health IT landscape, the desired future
state that the industry believes will be
necessary to enable a learning health
system, and a suggested path for moving
from the current state to the desired
future state. In the near term, the draft
Roadmap focuses on actions that will
enable a majority of individuals and
providers across the care continuum to
send, receive, find and use a common
set of electronic clinical information at
the nationwide level by the end of 2017.
The draft Roadmap’s goals also align
with the IMPACT Act of 2014 which
requires assessment data to be
standardized and interoperable to allow
for exchange of the data. Moreover, the
vision described in the draft Roadmap
significantly expands the types of
electronic health information,
information sources and information
users well beyond clinical information
derived from electronic health records
(EHRs). This shared strategy is intended
to reflect important actions that both
public and private sector stakeholders
can take to enable nationwide
interoperability of electronic health IT
such as: (1) Establishing a coordinated
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governance framework and process for
nationwide health IT interoperability;
(2) improving technical standards and
implementation guidance for sharing
and using a common clinical data set;
(3) enhancing incentives for sharing
electronic health information according
to common technical standards, starting
with a common clinical data set; and (4)
clarifying privacy and security
requirements that enable
interoperability.
In addition, ONC has released the
draft version of the 2015 Interoperability
Standards Advisory (available at https://
www.healthit.gov/standards-advisory),
which provides a list of the best
available standards and implementation
specifications to enable priority health
information exchange functions.
Providers, payers, and vendors are
encouraged to take these ‘‘best available
standards’’ into account as they
implement HIE across the continuum of
care, including care settings such as
behavioral health, long-term and postacute care, and home and communitybased service providers.
We encourage stakeholders to utilize
HIE and certified health IT to effectively
and efficiently help providers improve
internal care delivery practices, support
management of care across the
continuum, enable the reporting of
electronically specified clinical quality
measures (eCQMs), and improve
efficiencies and reduce unnecessary
costs. As adoption of certified health IT
increases and interoperability standards
continue to mature, HHS will seek to
reinforce standards through relevant
policies and programs.
The comments we received on this
topic, with their responses, appear
below.
Comment: All of the comments
received on this topic supported the
overall agency goal to accelerate HIE
within SNFs, and among the post-acute
care providers generally. One
commenter asked CMS to keep in mind
that certain types of clinicians, such as
physical therapists, operate in different
provider settings. Another commenter
urged CMS to consider the potential
impact of HIE regulations and policies
on innovation and business practices.
Finally, one commenter urged CMS to
provide the same type of incentives and
considerations to post-acute care
providers as they do in other areas with
regard to accelerating HIE.
Response: We appreciate the broad
support for this initiative and the
helpful suggestions provided by the
commenters. We will share these
comments with the appropriate CMS
staff and other governmental agencies to
ensure they are taken into account as we
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continue to encourage adoption of
health information technology.
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3. SNF Quality Reporting Program
(QRP)
a. Background and Statutory Authority
We seek to promote higher quality
and more efficient health care for
Medicare beneficiaries, and our efforts
are furthered by QRPs coupled with
public reporting of that information.
Such QRPs already exist for various
settings such as the Hospital Inpatient
Quality Reporting (HIQR) Program, the
Hospital Outpatient Quality Reporting
(HOQR) Program, the Physician Quality
Reporting System, the Long-Term Care
Hospital (LTCH) QRP, the Inpatient
Rehabilitation Facility (IRF) QRP, the
Home Health Quality Reporting Program
(HHQRP), and the Hospice Quality
Reporting Program (HQRP). We have
also implemented QRPs for home health
agencies (HHAs) that are based on
conditions of participation, and an
ESRD QIP and a Hospital Value-Based
Purchasing (HVBP) Program that link
payment to performance.
SNFs are providers that must meet
conditions of participation for Medicare
to receive Medicare payments. Some
SNFs are also certified under Medicaid
as nursing facilities (NFs), and these
types of long-term care facilities furnish
services to both Medicare beneficiaries
and Medicaid enrollees. SNFs provide
short-term skilled nursing services,
including but not limited to
rehabilitative therapy, physical therapy,
occupational therapy, and speechlanguage pathology services. Such
services are provided to beneficiaries
who are recovering from surgical
procedures, such as hip and knee
replacements, or from medical
conditions, such as stroke and
pneumonia. SNF services are provided
when needed to maintain or improve a
beneficiary’s current condition, or to
prevent a condition from worsening.
The care provided in a SNF (as a freestanding facility or part of a hospital), is
aimed at enabling the beneficiary to
maintain or improve his/her health and
to function independently. SNF care is
a benefit under Medicare Part A and
such care is covered for up to 100 days
in a benefit period if all coverage
requirements are met.15 In 2014, 2.6
million covered Medicare Part A stays
occurred within 15,421 SNFs.
Section 1888(e)(6)(B)(i)(II) of the Act
requires that each SNF submit, for FYs
beginning on or after the specified
application date (as defined in section
15 Section 1812(a)(2) and (b)(2) of the Act; 42 CFR
409.61; https://www.medicare.gov/Pubs/pdf/
10153.pdf.
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1899B(a)(2)(E) of the Act), data on
quality measures specified under
section 1899B(c)(1) of the Act and data
on resource use and other measures
specified under section 1899B(d)(1) of
the Act in a manner and within the
timeframes specified by the Secretary.
In addition, section 1888(e)(6)(B)(i)(III)
of the Act requires, for FYs beginning on
or after October 1, 2018, that each SNF
submit standardized patient assessment
data required under section 1899B(b)(1)
of the Act in a manner and within the
timeframes specified by the Secretary.
Section 1888(e)(6)(A)(i) of the Act
requires that, for FYs beginning with FY
2018, if a SNF does not submit data, as
applicable, on quality and resource use
and other measures in accordance with
section 1888(e)(6)(B)(i)(II) of the Act and
on standardized patient assessment in
accordance with section
1888(e)(6)(B)(i)(III) of the Act for such
FY, the Secretary reduce the market
basket percentage described in section
1888(e)(5)(B)(ii) of the Act by 2
percentage points.
The IMPACT Act adds section 1899B
to the Act that imposes new data
reporting requirements for certain PAC
providers, including SNFs. Sections
1899B(c)(1) and 1899B(d)(1) of the Act
collectively require that the Secretary
specify quality measures and resource
use and other measures with respect to
certain domains not later than the
specified application date in section
1899B(a)(2)(E) of the Act that applies to
each measure domain and PAC provider
setting. The IMPACT Act also amends
section 1886(e)(6) of the Act, to require
the Secretary to reduce the PPS
payments to a SNF that does not submit
the data required in a form and manner,
and at a time, specified by the Secretary.
Section 1886(e)(6)(A)(i) of the Act
would require the Secretary in a FY
beginning with FY 2018 to reduce by 2
percentage points the market basket
percentage increase as adjusted by the
productivity adjustment for SNFs that
do not submit the required data.
Under the SNF QRP, we proposed
that the general timeline and sequencing
of measure implementation would occur
as follows: (1) Specification of
measures; (2) proposal and finalization
of measures through notice-andcomment rulemaking; (3) SNF
submission of data on the adopted
measures; analysis and processing of the
submitted data; (4) notification to SNFs
regarding their quality reporting
compliance with respect to a particular
FY; (5) review of any reconsideration
requests; and (6) imposition of a
payment reduction in a particular FY for
failure to satisfactorily submit data with
respect to that FY. We also proposed
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that any payment reductions that are
taken for a FY for the QRP would begin
approximately 1 year after the end of the
data submission period for that FY and
approximately 2 years after we first
adopt the measure.
This timeline, which is similar in the
other QRPs, reflects operational and
other practical constraints, including
the time needed to specify and adopt
valid and reliable measures, collect the
data, and determine whether a SNF has
complied with our quality reporting
requirements. It also takes into
consideration our desire to give SNFs
enough notice of new data reporting
obligations so that they are prepared to
start reporting the data in a timely
fashion. Therefore, we stated our
intention to follow the same timing and
sequence of events for measures
specified under section 1899B(c)(1) and
(d)(1) of the Act that we currently follow
for the other QRPs. We stated our
intention to specify each of these
measures no later than the specified
application dates set forth in section
1899B(a)(2)(E) of the Act and proposed
to adopt them consistent with the
requirements in the Act and
Administrative Procedure Act. To the
extent that we finalize to adopt a
measure for the SNF QRP that satisfies
an IMPACT Act measure domain, we
stated our intention to require SNFs to
report data on the measure for the FY
that begins 2 years after the specified
application date for that measure.
Likewise, we stated our intention to
require SNFs to begin reporting any
other data specifically required under
the IMPACT Act for the FY that begins
2 years after we adopt requirements that
would govern the submission of that
data.
We received multiple public
comments pertaining to the general
timeline and plan for implementation of
the IMPACT Act, sequencing of measure
implementation, standardization of PAC
assessment tools, and timing of payment
consequences for the failure to comply
with reporting requirements. The
following is a summary of the comments
received on this topic and our
responses.
Comment: We received several
comments regarding the timing of the
development of the IMPACT Act
measures, the development of
associated data elements, data collection
and reporting. One commenter noted
the considerable time constraints under
which the Secretary is required to
implement the provisions of the
IMPACT Act. Several commenters
requested that CMS communicate
estimated implementation timelines for
all data collection and reporting
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requirements. One commenter requested
that CMS provide more detailed
information in the rule regarding
multiple topics, including the
replacement of existing data elements in
the PAC assessment tools with a
suggested common assessment tool,
endorsement of quality measures, and
the sequence and timeline of events for
measure implementation.
Response: We appreciate the public’s
feedback regarding the timing issues
related to IMPACT Act implementation.
We recognize the need for transparency
as we move forward to implement the
provisions of the IMPACT Act and we
intend to continue to engage
stakeholders and ensure that our
approach to implementation and timing
is communicated in an open and
informative manner. We will use the
rulemaking process to communicate
timelines for implementation, including
timelines for the replacement of items in
PAC assessment tools, timelines for
implementation of new or revised
quality measures and timelines for
public reporting. We will also provide
information through pre-rulemaking
activities surrounding the development
of quality measures, which includes
public input as part of our process.
Additionally, we intend to engage
stakeholders and experts in developing
the assessment instrument
modifications necessary to meet data
standardization requirements of the
IMPACT Act.
We will also continue to provide
information about measures at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014-andCross-Setting-Measures.html.
Comment: We received several
comments requesting the development
of a comprehensive overall plan for
implementation across all settings
covered by the IMPACT Act.
Commenters stated that a
comprehensive implementation plan
would give PAC providers an
opportunity to plan for the potential
impacts on their operations, and enable
all stakeholders to understand CMS’s
approach to implementing the IMPACT
Act across care settings. One commenter
requested that CMS plans be
communicated as soon as possible and
that CMS develop setting-specific
communications to facilitate
understanding of the IMPACT Act
requirements.
Response: We appreciate the request
for a comprehensive plan to allow PAC
providers to plan for implementation of
the IMPACT Act, as well as the need for
stakeholder input, the development of
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reliable, accurate measures, clarity on
the level of standardization of items and
measures, and avoidance of unnecessary
burden on PAC providers. Our intent
has been to comply with these
principles in the implementation and
rollout of QRPs in the various care
settings, and we will continue to adhere
to these principles as the agency moves
forward with implementing IMPACT
Act requirements.
In addition, in implementing the
IMPACT Act requirements, we will
follow the strategy for identifying crosscutting measures, timelines for data
collection and timelines for reporting as
outlined in the IMPACT Act. As
described more fully above, the
IMPACT Act requires CMS to specify
measures that relate to at least five
stated quality domains and three stated
resource use and other measure
domains. The IMPACT Act also outlines
timelines for data collection and
timelines for reporting. In addition, we
must follow all processes in place for
adoption of measures including the
MAP and the notice and comment
rulemaking process. In our selection and
specification of measures, we employ a
transparent process in which we seek
input from stakeholders and national
experts and engage in a process that
allows for pre-rulemaking input on each
measure, as required by section 1890A
of the Act. This process is based on a
private-public partnership, and it occurs
via the MAP. The MAP is composed of
multi-stakeholder groups convened by
the NQF, our current contractor under
section 1890 of the Act, to provide input
on the selection of quality and
efficiency measures described in section
1890(b)(7)(B). The NQF must convene
these stakeholders and provide us with
the stakeholders’ input on the selection
of such measures. We, in turn, must take
this input into consideration in
selecting such measures. In addition,
the Secretary must make available to the
public by December 1 of each year a list
of such measures that the Secretary is
considering under Title XVIII of the Act.
Additionally, proposed measures and
specifications are to be announced
through the Notice of Proposed
Rulemaking (NPRM) process in which
proposed rules are published in the
Federal Register and are available for
public view and comment.
Comment: We received several
comments about the level of
standardization of data collection
instruments across PAC settings as
required by the IMPACT Act.
Commenters noted the importance of
standardized resident assessment data
for cross-setting comparisons of patient
outcomes. Some commenters recognized
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the need to have as much
standardization of measures and data
collection across PAC settings as
possible, while recognizing that some
variations among settings may be
necessary. Those commenters cautioned
that complete standardization of PAC
data may not be possible and urged
CMS to consider standardization around
topics or domains but allowing different
settings to use assessment instruments
that were most appropriate for the
patient populations assessed. One
commenter requested that the specific
items added to achieve standardization
to the Minimum Data Set (MDS) for
NFs, the Outcome and Assessment
Information Set (OASIS) for home
healthcare, the Inpatient Rehabilitation
Facility Patient Assessment Instrument
(IRF PAI), and Long-Term Care
Hospitals Continuity Assessment
Record and Evaluation data set (LTCH–
CARE) be published for comments.
Response: We agree that
standardization is important for data
comparability and outcome analysis.
The IMPACT Act requires the
modification of the assessment
instruments to include standardized
data for multiple purposes including
quality reporting, interoperability and
data comparison, and we will work to
ensure that items pertaining to measures
required under the IMPACT Act that are
used in assessment instruments are
standardized. We agree that there may
be instances where such data is not
necessary or applicable to all four of the
post-acute settings’ assessment
instruments, but is used in more than
one assessment instrument. In that
circumstance, we work to ensure that
such data is standardized.
With regard to the commenter’s
suggestion that a common assessment
tool be developed for PAC settings, we
wish to clarify that while the IMPACT
Act requires the modification of PAC
assessment instruments to revise or
replace certain existing patient
assessment data with standardized
patient assessment data as soon as
practicable, it does not require a single
data collection tool. We intend to
modify the existing PAC assessment
instruments as soon as practicable to
ensure the collection of standardized
data. While we agree that it is possible
that within the PAC assessment
instruments certain sections could
incorporate a standardized assessment
data collection tool, for example, the
Brief Interview for Mental Status
(BIMS), we have not yet concluded that
this kind of modification of the PAC
assessment instruments is necessary.
All proposed and finalized changes to
the PAC instruments are, and will
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continue to be, published on the
applicable CMS Web sites. As
previously mentioned, it is our
intention to develop such
standardization through clinical and
expert input as well as stakeholder and
public engagement where we would
receive input.
Comment: We received many
comments about the burden on PAC
providers of meeting new requirements
imposed as a result of the
implementation of the IMPACT Act.
Commenters requested that CMS
consider minimizing the burden for
PAC providers when possible and avoid
duplication in data collection.
Response: We appreciate the
importance of avoiding undue burden
and will continue to evaluate and
consider any burden the IMPACT Act
and the SNF QRP places on SNFs. In
implementing the IMPACT Act thus far,
we have taken into consideration the
new burden that our requirements place
on PAC providers, and we believe that
standardizing patient assessment data
will allow for the exchange of data
among PAC providers in order to
facilitate care coordination and improve
patient outcomes.
Comment: We received one comment
requesting that, in the future, crosssetting measures and assessment data
changes related to the IMPACT Act be
addressed in one stand-alone notice and
rule that applies to all four post-acute
care settings.
Response: We will take this
suggestion under consideration.
Comment: One commenter expressed
support for the reduction of a SNF’s
annual update by 2 percentage points
for failure to report the required quality
data. Additionally, this commenter
recommends that imposition of the
financial penalty should be published
on a public reporting Web site.
Response: We thank the commenter
for its support of the SNF QRP
reduction as mandated by the IMPACT
Act, and the suggestion to publicize
payment consequences imposed upon
SNFs for failure to satisfactorily report
quality data. We will take this under
consideration.
Final Decision: After consideration of
the public comments received, we are
finalizing the adoption of general
timeline and sequencing of measure
implementation and that any payment
reductions that are taken with respect to
a FY would begin approximately 1 year
after the end of the data submission
period for that FY and approximately 2
years after we first adopt the measure as
proposed for the SNF QRP.
As provided at section
1888(e)(6)(A)(ii) of the Act, depending
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on the market basket percentage for a
particular year, the 2 percentage point
reduction under section 1888(e)(6)(A)(i)
of the Act may result in this percentage,
after application of the productivity
adjustment under section
1888(e)(5)(B)(ii) of the Act, being less
than 0.0 percent for a FY and may result
in payment rates under the SNF PPS
being less than payment rates for the
preceding FY. In addition, as set forth
at section 1888(e)(6)(A)(iii) of the Act,
any reduction based on failure to
comply with the SNF QRP reporting
requirements applies only to the
particular FY involved, and any such
reduction must not be taken into
account in computing the SNF PPS
payment rates for subsequent FYs.
For purposes of meeting the reporting
requirements under the SNF QRP,
section 1888(e)(6)(B)(ii) of the Act states
that SNFs or other facilities described in
section 1888(e)(7)(B) of the Act (other
than a CAH) may submit the resident
assessment data required under section
1819(b)(3) of the Act using the standard
instrument designated by the state
under section 1819(e)(5) of the Act.
Currently, the resident assessment
instrument is titled the MDS 3.0. To the
extent data required for submission
under subclause (II) or (III) of section
1888(e)(6)(B)(i) of the Act duplicates
other data required to be submitted
under clause (i)(I), section
1888(e)(6)(B)(iii) provides that the
submission of data under subclause (II)
or (III) is to be in lieu of the submission
of such data under clause (I), unless the
Secretary makes a determination that
such duplication is necessary to avoid
delay in the implementation of section
1899B of the Act taking into account the
different specified application dates
under section 1899B(a)(2)(E) of the Act.
In addition to requiring a QRP for
SNFs under new section 1888(e)(6), the
IMPACT Act requires feedback to SNFs
and public reporting of their
performance. More specifically, section
1899B(f)(1) of the Act requires the
Secretary to provide confidential
feedback reports to SNFs on their
performance on the quality measures
and resource use and other measures
specified under that section. The
Secretary must make such confidential
feedback reports available to SNFs
beginning 1 year after the specified
application date that applies to the
measures in that section and, to the
extent feasible, no less frequently than
on a quarterly basis, except in the case
of measures reported on an annual
basis, as to which the confidential
feedback reports may be made available
annually.
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Section 1899B(g)(1) of the Act
requires the Secretary to provide for the
public reporting of SNF performance on
the quality measures specified under
section 1899B(c)(1) of the Act and the
resource use and other measures
specified under section 1899B(d)(1) of
the Act by establishing procedures for
making the performance data available
to the public. Such procedures must
ensure, including through a process
consistent with the process applied
under section 1886(b)(3)(B)(viii)(VII) of
the Act, that SNFs have the opportunity
to review and submit corrections to the
data and other information before it is
made public as required by section
1899B(g)(2) of the Act. Section
1899B(g)(3) of the Act requires that the
data and information is made publicly
available beginning no later than 2 years
after the specified application date
applicable to such a measure and SNFs.
Finally, section 1899B(g)(4)(B) of the
Act requires that such procedures must
provide that the data and information
described in section 1899B(g)(1) of the
Act for quality and resource use
measures be made publicly available
consistent with sections 1819(i) and
1919(i) of the Act.
b. General Considerations Used for
Selection of Quality Measures for the
SNF QRP
We strive to promote high quality and
efficiency in the delivery of health care
to the beneficiaries we serve.
Performance improvement leading to
the highest quality health care requires
continuous evaluation to identify and
address performance gaps and reduce
the unintended consequences that may
arise in treating a large, vulnerable, and
aging population. QRPs, coupled with
public reporting of quality information,
are critical to the advancement of health
care quality improvement efforts.
Valid, reliable, relevant quality
measures are fundamental to the
effectiveness of our QRPs. Therefore,
selection of quality measures is a
priority for CMS in all of its QRPs.
We proposed to adopt for the SNF
QRP three measures that we are
specifying under section 1899(B)(c)(1) of
the Act for purposes of meeting the
following three domains: (1) Functional
status, cognitive function, and changes
in function and cognitive function; (2)
skin integrity and changes in skin
integrity; and (3) incidence of major
falls. These measures align with the
CMS Quality Strategy,16 which
16 https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/
QualityInitiativesGenInfo/CMS-QualityStrategy.html.
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incorporates the three broad aims of the
National Quality Strategy: 17
• Better Care: Improve the overall
quality of care by making healthcare
more patient-centered, reliable,
accessible, and safe.
• Healthy People, Healthy
Communities: Improve the health of the
U.S. population by supporting proven
interventions to address behavioral,
social, and environmental determinants
of health in addition to delivering
higher-quality care.
• Affordable Care: Reduce the cost of
quality healthcare for individuals,
families, employers, and government.
In deciding to propose these
measures, we also took into account
national priorities, including those
established by the National Priorities
Partnership (https://
www.qualityforum.org/Setting_
Priorities/NPP/National_Priorities_
Partnership.aspx), and the HHS
Strategic Plan (https://www.hhs.gov/
secretary/about/priorities/
priorities.html).
These measures also incorporate
common standards and definitions that
can be used across post-acute care
settings to allow for the exchange of
data among post-acute care providers, to
provide access to longitudinal
information for such providers to
facilitate coordinated and improved
outcomes, and to enable comparison of
such assessment data across all such
providers as required by section
1899B(a) of the Act.
We received comments on the topic of
the General Considerations Used for
Selection of Quality Measures for the
SNF QRP. The following is a summary
of the comments received and our
responses.
Comment: One commenter expressed
support for the goals and principles
outlined to improve quality and help
guide the selection and specification of
measures in the SNF QRP.
Response: We appreciate the support.
Comment: While we received some
comments expressing appreciation for
opportunities for stakeholder feedback
regarding implementation of the
IMPACT Act, we also received several
comments regarding the need for more
opportunities for stakeholder input into
various aspects of the measure
development process. Commenters
requested opportunities to provide early
and ongoing input into measure
development. One commenter requested
opportunities for input prior to the
development of proposed measure
specifications. Commenters requested
17 https://www.ahrq.gov/workingforquality/nqs/
nqs2011annlrpt.htm.
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that CMS hold meetings with PAC
providers on a frequent and regular
basis to provide feedback on
implementation and resolve any
perceived inconsistencies in the
proposed rule.
Response: We appreciate the
commenter’s feedback. It is our intent to
move forward with IMPACT Act
implementation in a manner in which
the measure development process
continues to be transparent, and
includes input and collaboration from
experts, the PAC provider community,
and the public at large. It is of the
utmost importance to CMS to continue
to engage stakeholders, including
patients and their families, throughout
the measure development lifecycle
through their participation in our
measure development public comment
periods; the pre-rulemaking process;
participation in the TEPs provided by
our measure development contractors,
as well as open door forums and other
opportunities. We have already
provided multiple opportunities for
stakeholder input, which include the
following activities: our measure
development contractor(s) convened a
TEP that included stakeholder experts
on February 3, 2015; we convened two
separate listening sessions on February
10th and March 24, 2015; we heard
stakeholder input during the February
9th 2015 ad hoc MAP meeting provided
for the sole purpose of reviewing the
measures adopted in response to the
IMPACT Act. Additionally, we
implemented a public mail box for the
submission of comments in January
2015, PACQualityInitiative@
cms.hhs.gov, which is listed on our
post-acute care quality initiatives Web
site at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014-andCross-Setting-Measures.html, and we
held a Special Open Door Forum to seek
input on the measures on February 25,
2015. The slides from the Special Open
Door Forum are available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014-andCross-Setting-Measures.html.
Comment: One commenter expressed
concern at the brief time between the
passage of the IMPACT Act and the
development of the proposed rule
because it did not allow for extensive
coordination with the professional
community. While the commenter
appreciated the opportunity to
participate in the IMPACT Act listening
session, the commenter viewed the
proposed rule for the SNF QRP as hasty
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and reactive, contrary to the deliberate
and measured process that was
recommended by stakeholders and
sought by CMS through the
collaborative listening session.
Response: We appreciate the public’s
interest in active participation in the
measure development process. As noted
in the proposed rule, the timeline and
sequence of events proposed for the
SNF QRP, which is generally followed
in other quality reporting programs,
requires that we give providers
sufficient time after adoption of
measures and before reporting
obligations begin to enable them to
prepare to report the data. We intend to
propose measures consistent with the
sequence we follow in other quality
reporting programs. As noted above, we
engaged in multiple activities to solicit
stakeholder input including TEPs,
listening sessions, ad hoc MAP
meetings, Special Open Door Forums
and a public email address. As
described above, we also initiated an Ad
Hoc MAP process to obtain input on the
measures that we are finalizing in this
final rule.
On February 5th, 2015, we made
publicly available a list of Measures
Under Consideration (called the ‘‘List of
Ad Hoc Measures Under Consideration
for the Improving Medicare Post-Acute
Care Transformation (IMPACT) Act of
2014’’) (MUC list) as part of an Ad Hoc
MAP convened by the NQF. The MAP
Post-Acute Care/Long-Term Care
Workgroup convened on February 9,
2015 to ‘‘review the measures technical
properties as they are adapted for use in
new settings and whether the new
settings impact the measures’ adherence
to the NQF Scientific Acceptability
criterion.’’ 18 The NQF published the
MUC list on our behalf for public
comment from February 11, 2015
through February 19, 2015 on its Web
site. The MAP Coordinating Committee
convened on February 27, 2015 to
discuss the public comments received,
and those public comments are listed
here https://public.qualityforum.org/
MAP/
MAP%20Coordinating%20Committee/
MAP_CC%20Feb%2027_Discussion_
Guide.html#agenda.
The MAP issued a pre-rulemaking
report on March 6, 2015. This PreRulemaking Report is available for
download at https://
www.qualityforum.org/Project_Pages/
MAP_Post-Acute_CareLong-Term_Care_
Workgroup.aspx. The MAP’s input for
18 . Ad-hoc Review: Expansion of Settings . (n.d.).
Retrieved March 5, 2015, from https://
www.qualityforum.org/Projects/a-b/Ad_Hoc_
Reviews/CMS/Ad_Hoc_Reviews-CMS.aspx.
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each of the proposed measures is
discussed in this section.
Section 1899B(j) of the Act requires
that we allow for stakeholder input as
part of the pre-rulemaking process.
Therefore, we sought stakeholder input
on the measures we proposed to adopt
in this final rule as follows: We
implemented a public mail box for the
submission of comments in January
2015, PACQualityInitiative@
cms.hhs.gov which is located on our
post-acute care quality initiatives Web
site at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014-andCross-Setting-Measures.html; we
convened a TEP that included
stakeholder experts and patient
representatives on February 3, 2015; and
we sought public input during the
February 2015 ad hoc MAP process. In
addition, we held a National
Stakeholder Special Open Door Forum
on February 25, 2015 for the purpose of
seeking input on these measures. Lastly,
we held two separate listening sessions
on February 10 and March 24, 2015,
respectively. These sessions sought
feedback from providers regarding best
practices for collecting quality data with
respect to the IMPACT Act
requirements.
Comment: Multiple commenters
expressed concern that the MAP process
was not implemented properly and had
concerns about when MAP Workgroup
rosters are open for public comment, the
inclusion of additional measures during
the MAP, and other items such as MAP
composition. Commenters also
expressed concern that the open door
forums and listening sessions designed
to meet public input requirements did
not include sufficient public discussion
of the proposed quality measures. One
commenter stated that there is
confusion among NQF and MAP
members over whether they can review
all related NQF-endorsed measures or
are restricted to reviewing only
measures preferred by CMS and
requested that CMS issue them written
guidance. In addition, the commenter
urged CMS to change the MAP public
comment process.
Response: With regard to the
commenters’ concerns pertaining to the
processes associated with the MAP such
as when MAP Workgroup rosters are
open for public comment, the inclusion
of additional measures during the MAP,
and other items such as MAP
composition, we note that the
operations of the MAP are directed by
the NQF, and not by CMS. Further,
while the MAP provides input on
measures selected by the Secretary, the
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pre rulemaking provisions of the Act do
not restrict the MAP from reviewing or
recommending alternative measures and
methodologies to those proposed by the
Secretary. Therefore, we refer readers to
the MAP Web site at https://www.quality
forum.org/map/. Additionally, we
intend to provide the commenters’ input
to the NQF.
We also, as part of our measure
development process for the proposed
measures, sought public input at the
February 2015 Special Open Door
Forum, during which we provided
information pertaining to the IMPACT
Act and the measures that were listed as
Measures Under Consideration for the
IMPACT Act of 2014 for review by the
MAP. We also advised that interested
parties could submit feedback and
questions on the measures and other
topics, via our mailbox, PACQuality
Initiative@cms.hhs.gov. We also sought
feedback from subject matter experts
who responded to an open call to
participate in the numerous TEPs held
by our measure development contractor
for all measures considered for adoption
into the SNF QRP prior to rulemaking.
c. Policy for Retaining SNF QRP
Measures for Future Payment
Determinations
For the SNF QRP, for the purpose of
streamlining the rulemaking process, we
proposed that when we adopt a measure
for the SNF QRP for a payment
determination, this measure would be
automatically retained in the SNF QRP
for all subsequent payment
determinations unless we propose to
remove, suspend, or replace the
measure.
Section 1899B(h)(1) of the Act
provides that the Secretary may remove,
suspend or add a quality measure or
resource use or other measure specified
under section 1899B(c)(1) or (d)(1) of
the Act so long as the Secretary
publishes a justification for the action in
the Federal Register with a notice and
comment period. Consistent with the
policies of other QRPs including the
HIQR Program, the HOQR Program,
LTCH QRP, and the IRF QRP, we
proposed that quality measures would
be considered for removal if: (1)
Measure performance among SNFs is so
high and unvarying that meaningful
distinctions in improvements in
performance can no longer be made in
which case the measure may be
removed or suspended; (2) performance
or improvement on a measure does not
result in better resident outcomes; (3) a
measure does not align with current
clinical guidelines or practice; (4) a
more broadly applicable measure
(across settings, populations, or
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46431
conditions) for the particular topic is
available; (5) a measure that is more
proximal in time to desired resident
outcomes for the particular topic is
available; (6) a measure that is more
strongly associated with desired
resident outcomes for the particular
topic is available; or (7) collection or
public reporting of a measure leads to
negative unintended consequences
other than resident harm.
We also noted that under section
1899B(h)(2) of the Act, in the case of a
quality measure or resource use or other
measure for which there is a reason to
believe that the continued collection
raises possible safety concerns or would
cause other unintended consequences,
the Secretary may promptly suspend or
remove the measure and publish the
justification for the suspension or
removal in the Federal Register during
the next rulemaking cycle.
For any measure that meets this
criterion (that is, a measure that raises
safety concerns), we will take
immediate action to remove the measure
from SNF QRP, and, in addition to
publishing a justification in the next
rulemaking cycle, will immediately
notify SNFs and the public through the
usual communication channels,
including listening session, memos,
email notification, and web postings.
We invited public comment on this
proposed policy for Retaining SNF QRP
Measures for Future Payment
Determinations. The following is a
summary of the comments received and
our responses.
Comment: One commenter supported
several of the criteria for possible
removal of a measure but opposed or
recommended changes to other criteria.
The commenter recommended changes
to deleting criteria to remove measures
that have high performance, remove or
clarify phrases associated with the term
‘‘clinical practice,’’ and also
incorporating language to clarify how to
add measures rather than remove them.
Response: We interpret the comment
to mean that CMS should maintain
measures that have high performance.
We required reporting on measures with
high performance rates in the past. We
will continue to perform a case-by-case
analysis through program monitoring to
evaluate the importance of measure
continuation vs. measure suppression or
removal. Additionally, we will evaluate
the application of language and phrases
associated with the term clinical
practice as necessary. We believe that
we have addressed the approach we
take in measure selection and proposal
for adoption in our preamble, and when
we present our measures under
consideration. Generally, we apply an
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approach that involves alignment with
the National Quality Strategy, and the
CMS Quality Strategy, with an effort to
address gaps in quality and priority
areas for achieving high quality care. We
note that the proposed criteria for
consideration for removal of measures
in the SNF QRP are consistent with the
policies of other QRPs in the Medicare
Program, including the HIQR Program,
the HOQR Program, LTCH QRP, and the
IRF QRP.
After consideration of the public
comments received, we are finalizing
the adoption of the policy for retaining
SNF QRP Measures for Future Payment
Determinations as proposed.
d. Process for Adoption of Changes to
SNF QRP Program Measures
Section 1899B(e)(2) required that
quality measures under the IMPACT Act
selected for the SNF QRP must be
endorsed by the NQF unless they meet
the criteria for exception in section
1899B(e)(2)(B) of the Act. The NQF is a
voluntary consensus standard-setting
organization with a diverse
representation of consumer, purchaser,
provider, academic, clinical, and other
healthcare stakeholder organizations.
The NQF was established to standardize
healthcare quality measurement and
reporting through its consensus
development process (https://
www.qualityforum.org/About_NQF/
Mission_and_Vision.aspx). The NQF
undertakes review of: (a) New quality
measures and national consensus
standards for measuring and publicly
reporting on performance; (b) regular
maintenance processes for endorsed
quality measures; (c) measures with
time-limited endorsement for
consideration of full endorsement; and
(d) ad hoc review of endorsed quality
measures, practices, consensus
standards, or events with adequate
justification to substantiate the review
(https://www.qualityforum.org/
Measuring_Performance/Ad_Hoc_
Reviews/Ad_Hoc_Review.aspx).
The NQF solicits information from
measure stewards for annual reviews
and to review measures for continued
endorsement in a specific 3-year cycle.
In this measure maintenance process,
the measure steward is responsible for
updating and maintaining the currency
and relevance of the measure and for
confirming existing specifications to the
NQF on an annual basis. As part of the
ad hoc review process, the ad hoc
review requester and the measure
steward are responsible for submitting
evidence for review by a NQF TEP
which, in turn, provides input to the
Consensus Standards Approval
Committee which then makes a decision
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on endorsement status and/or
specification changes for the measure,
practice, or event.
The NQF regularly maintains its
endorsed measures through annual and
triennial reviews, which may result in
the NQF making updates to the
measures. We believe that it is
important to have in place a
subregulatory process to incorporate
nonsubstantive updates made by the
NQF into the measure specifications as
we have adopted for the Hospital IQR
Program so that these measures remain
up-to-date. We also recognize that some
changes the NQF might make to its
endorsed measures are substantive in
nature and might not be appropriate for
adoption using a subregulatory process.
Therefore, in the FY 2013 IPPS/LTCH
PPS final rule (77 FR 53504 through
53505), we finalized a policy under
which we use a subregulatory process to
make nonsubstantive updates to
measures used for the Hospital IQR
Program. For what constitutes
substantive versus nonsubstantive
changes, we expect to make this
determination on a case-by-case basis.
Examples of nonsubstantive changes to
measures might include updated
diagnosis or procedure codes,
medication updates for categories of
medications, broadening of age ranges,
and exclusions for a measure (such as
the addition of a hospice exclusion to
the 30-day mortality measures). We
believe that nonsubstantive changes
may include updates to NQF-endorsed
measures based upon changes to
guidelines upon which the measures are
based.
Therefore, we proposed to use
rulemaking to adopt substantive updates
made to measures as we have for the
Hospital IQR Program. Examples of
changes that we might consider to be
substantive would be those in which the
changes are so significant that the
measure is no longer the same measure,
or when a standard of performance
assessed by a measure becomes more
stringent (for example, changes in
acceptable timing of medication,
procedure/process, or test
administration). Another example of a
substantive change would be where the
NQF has extended its endorsement of a
previously endorsed measure to a new
setting, such as extending a measure
from the inpatient setting to hospice.
These policies regarding what is
considered substantive versus
nonsubstantive would apply to all
measures in the SNF QRP. We also note
that the NQF process incorporates an
opportunity for public comment and
engagement in the measure maintenance
process.
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We believe this policy adequately
balances our need to incorporate
updates to the SNF QRP measures in the
most expeditious manner possible while
preserving the public’s ability to
comment on updates that so
fundamentally change an endorsed
measure that it is no longer the same
measure that we originally adopted.
We invited public comment on our
Proposed Process for the Adoption of
Changes to SNF QRP Program Measures.
The following is a summary of the
comments received and our responses.
Comment: One commenter suggested
that CMS more clearly define the
subregulatory process criteria for
determining what constitutes a nonsubstantive change and recommended
that CMS not wait until rulemaking to
make changes that are considered
substantive and have progressed
through the NQF process.
Response: We believe that it is
important to have in place a
subregulatory process to incorporate
nonsubstantive updates made by the
NQF into the measure specifications so
that the measures remain up-to-date. For
example, we could use the CMS Web
site as a place to announce changes. As
noted in the proposed rule, the
subregulatory process proposed is the
same process as we have adopted for the
Hospital IQR Program and which has
been used successfully in that program.
We believe that the criteria for what
constitutes a non-substantive change
could vary widely and is best described
by examples, as we have done in the
proposed rule. As noted, what
constitutes a substantive versus
nonsubstantive changes is determined
on a case-by-case basis.
Final Decision: After consideration of
the public comments, we are finalizing
the adoption of the Process for Adoption
of Changes to SNF QRP Program
Measures.
New Quality Measures for FY 2018 and
Subsequent Payment Determinations
For the FY 2018 SNF QRP and
subsequent years, we proposed to adopt
three cross-setting quality measures to
meet the requirements of the IMPACT
Act. These measures address the
following domains: (1) Skin integrity
and changes in skin integrity; (2)
incidence of major falls; and (3)
functional status, cognitive function,
and changes in function and cognitive
function, which are all required
measure domains under section
1899B(c)(1) of the Act. The proposed
quality measure addressing skin
integrity and changes in skin integrity is
the NQF-endorsed measure, Percent of
Residents or Patients with Pressure
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Ulcers That Are New or Worsened
(Short Stay) (NQF #0678) (https://
www.qualityforum.org/QPS/0678). The
proposed quality measure addressing
the incidence of major falls is an
application of the NQF-endorsed
Percent of Residents Experiencing One
or More Falls with Major Injury (Long
Stay) (NQF #0674) (https://
www.qualityforum.org/QPS/0674).
Finally, the proposed quality measure
addressing functional status, cognitive
function, and changes in function and
cognitive function is an application of
the Percent of Long-Term Care Hospital
Patients With an Admission and
Discharge Functional Assessment and a
Care Plan that Addresses Function (NQF
#2631; endorsed on July 23, 2015)
(https://www.qualityforum.org/QPS/
2631).
The proposed quality measures
addressing the domains of incidence of
major falls and functional status,
cognitive function, and changes in
function and cognitive function, are not
currently NQF-endorsed for the SNF
population. We reviewed the NQF’s
endorsed measures and were unable to
identify any NQF-endorsed cross-setting
quality measures that focused on these
domains. We are also unaware of any
other cross-setting quality measures that
have been endorsed or adopted by
another consensus organization.
Section 1899B(e)(2) of the Act
requires we use a NQF-endorsed
measure unless the measure meets the
exception. In the case of a specified area
or medical topic determined by the
Secretary for which a feasible and
practical measure has not been NQF
endorsed, the Secretary may specify a
measure that is not so endorsed as long
as due consideration is given to a
measure that has been endorsed or
adopted by a consensus organization
identified by the Secretary.
We received several general
comments pertaining to the topic of our
use of measures that are not endorsed or
are not endorsed for use in the SNF
resident population, as well as
processes related to our adoption of
such measures, their reliability and
processes pertaining to the NQF
endorsement process as well as the
MAP review process. The following is a
summary of the comments received and
our responses.
Comment: We received several
comments about the reliability and
accuracy of the proposed measures. We
also received several comments
supporting and encouraging the use of
NQF endorsed measures and
commenters expressed concerns that not
all of the measures proposed for the FY
2018 payment determination were NQF
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endorsed. One commenter expressed
concern that the statute’s exemption
allowing the use of measures that are
not NQF endorsed provided that ‘‘due
consideration’’ is given to endorsed
measures is not well defined. One
commenter urged CMS to use only
measures that have been NQF endorsed
as cross-setting measures and another
commenter expressed that all measures
should be reviewed by the MAP and a
technical expert panel (TEP).
Additionally, one commenter believed
that all measures should be NQF
endorsed before they are specified and
if the measure is not endorsed, CMS
should specify the criteria justifying the
exception to endorsement. In addition,
one commenter suggested that the NQF
endorsement process does not take into
account the expertise necessary for
rehabilitation services and post-acute
care services.
Response: We intend to consider and
propose appropriate measures that meet
the requirements of the IMPACT Act
measure domains and that have been
endorsed or adopted by a consensus
organization, whenever possible.
However, when this is not feasible
because there is no NQF-endorsed
measure that meets all the requirements
for a specified IMPACT Act measure
domain, we intend to rely on the
exception authority given to the
Secretary in section 1899B(e)(2)(B) of
the Act. This statutory exception, allows
the Secretary to specify a measure for
the SNF QRP setting that is not NQFendorsed where, as here, we have not
been able to identify other measures on
the topic that are endorsed or adopted
by a consensus organization. With
respect to the proposed measures for the
SNF QRP, we sought MAP review, as
well as expert opinion, on the validity
and reliability of those measures. We
disagree with the commenter who
expressed concerns pertaining to the
expertise applied in the panels
overseeing the NQF endorsement
proceedings; however, we intend to
provide this feedback to the NQF.
(1) Quality Measure Addressing the
Domain of Skin Integrity and Changes in
Skin Integrity: Percent of Residents or
Patients With Pressure Ulcers That Are
New or Worsened (Short Stay) (NQF
#0678)
We proposed to adopt for the SNF
QRP, beginning with the FY 2018
payment determination, the Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short Stay) (NQF #0678) measure as a
cross-setting quality measure that
satisfies the skin integrity and changes
in skin integrity domain. This measure
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46433
assesses the percentage of short-stay
residents or patients in SNFs, IRFs, and
LTCHs with Stage 2 through 4 pressure
ulcers that are new or worsened since
admission.
Pressure ulcers are a serious medical
condition that result in pain, decreased
quality of life, and increased mortality
in aging populations.19 20 21 22 Pressure
ulcers typically are the result of
prolonged periods of uninterrupted
pressure on the skin, soft tissue, muscle,
and bone.23 24 25 Older adults in SNFs
are prone to a wide range of medical
conditions that increase their risk of
developing pressure ulcers. These
medical conditions include impaired
mobility or sensation, malnutrition or
under-nutrition, obesity, stroke,
diabetes, dementia, cognitive
impairments, circulatory diseases,
dehydration, the use of wheelchairs,
medical devices, and a history of
pressure ulcers or a pressure ulcer at
admission.26 27 28 29 30 31 32 33 34 35 36
19 Casey, G. (2013). ‘‘Pressure ulcers reflect
quality of nursing care.’’ Nurs N Z 19(10): 20–24.
20 Gorzoni, M. L. and S. L. Pires (2011). ‘‘Deaths
in nursing homes.’’ Rev Assoc Med Bras 57(3): 327–
331.
21 Thomas, J. M., et al. (2013). ‘‘Systematic
review: health-related characteristics of elderly
hospitalized adults and nursing home residents
associated with short-term mortality.’’ J Am Geriatr
Soc 61(6): 902–911.
22 White-Chu, E. F., et al. (2011). ‘‘Pressure ulcers
in long-term care.’’ Clin Geriatr Med 27(2): 241–258.
23 Bates-Jensen BM. Quality indicators for
prevention and management of pressure ulcers in
vulnerable elders. Ann Int Med. 2001;135 (8 Part 2),
744–51.
24 Institute for Healthcare Improvement (IHI).
Relieve the pressure and reduce harm. May 21,
2007. Available from https://www.ihi.org/IHI/
Topics/PatientSafety/SafetyGeneral/Improvement
Stories/FSRelievethePressureandReduceHarm.htm
25 Russo CA, Steiner C, Spector W.
Hospitalizations related to pressure ulcers among
adults 18 years and older, 2006 (Healthcare Cost
and Utilization Project Statistical Brief No. 64).
December 2008. Available from https://
www.hcupus.ahrq.gov/reports/statbriefs/sb64.pdf.
26 Agency for Healthcare Research and Quality
(AHRQ). Agency news and notes: pressure ulcers
are increasing among hospital patients. January
2009. Available from https://www.ahrq.gov/
research/jan09/0109RA22.htm.=
27 Bates-Jensen BM. Quality indicators for
prevention and management of pressure ulcers in
vulnerable elders. Ann Int Med. 2001;135 (8 Part 2),
744–51.
28 Cai, S., et al. (2013). ‘‘Obesity and pressure
ulcers among nursing home residents.’’ Med Care
51(6): 478–486.
29 Casey, G. (2013). ‘‘Pressure ulcers reflect
quality of nursing care.’’ Nurs N Z 19(10): 20–24.
30 Hurd D, Moore T, Radley D, Williams C.
Pressure ulcer prevalence and incidence across
post-acute care settings. Home Health Quality
Measures & Data Analysis Project, Report of
Findings, prepared for CMS/OCSQ, Baltimore, MD,
under Contract No. 500–2005–000181 TO 0002.
2010.
31 MacLean DS. Preventing & managing pressure
sores. Caring for the Ages. March 2003;4(3):34–7.
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Section 1899B(a)(1)(B) of the IMPACT
Act requires that the data submitted on
quality measures under section
1899B(c)(1) of the Act be standardized
and interoperable across PAC settings,
and section 1899B(c)(2)(A) of the Act
requires that the measures be reported
through the use of a PAC assessment
instrument. These requirements are in
line with the NQF Steering Committee
report, which stated that ‘‘to understand
the impact of pressure ulcers across
settings, quality measures addressing
prevention, incidence, and prevalence
of pressure ulcers must be harmonized
and aligned.’’ 37 This measure has been
implemented in nursing homes for
resident population with stays of less
than 100 days under CMS’s Nursing
Home Quality Initiative. We also
adopted the measure for use in the
LTCH QRP (76 FR 51753 through 51756)
beginning with the FY 2014 payment
determination, and for use in the IRF
QRP (76 FR 47876 through 47878)
beginning with the FY 2014 payment
determination. We have not, to date,
adopted the measure for the home
health setting. More information on the
NQF endorsed quality measure the
Percent of Residents or Patients with
Pressure Ulcers That Are New or
Worsened (Short Stay) (NQF #0678), is
available at https://www.qualityforum.
org/QPS/0678.
A TEP convened by our measure
development contractor provided input
on the technical specifications of the
quality measure, the Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short Stay) (NQF #0678), including the
feasibility of implementing the measure
across PAC settings. The TEP supported
Available from https://www.amda.com/publications/
caring/march2003/policies.cfm.
32 Michel, J. M., et al. (2012). ‘‘As of 2012, what
are the key predictive risk factors for pressure
ulcers? Developing French guidelines for clinical
practice.’’ Ann Phys Rehabil Med 55(7): 454–465.
33 National Pressure Ulcer Advisory Panel
(NPUAP) Board of Directors; Cuddigan J, Berlowitz
DR, Ayello EA (Eds). Pressure ulcers in America:
prevalence, incidence, and implications for the
future. An executive summary of the National
Pressure Ulcer Advisory Panel Monograph. Adv
Skin Wound Care. 2001;14(4):208–15.
34 Park-Lee E, Caffrey C. Pressure ulcers among
nursing home residents: United States, 2004 (NCHS
Data Brief No. 14). Hyattsville, MD: National Center
for Health Statistics, 2009. Available from https://
www.cdc.gov/nchs/data/databriefs/db14.htm.
35 Reddy, M. (2011). ‘‘Pressure ulcers.’’ Clin Evid
(Online) 2011.
36 Teno, J. M., et al. (2012). ‘‘Feeding tubes and
the prevention or healing of pressure ulcers.’’ Arch
Intern Med 172(9): 697–701.
37 National Quality Forum. National voluntary
consensus standards for developing a framework for
measuring quality for prevention and management
of pressure ulcers. April 2008. Available from
https://www.qualityforum.org/Projects/Pressure_
Ulcers.aspx
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the measure’s implementation across
PAC settings and was also supportive of
our efforts to standardize the measure
for cross-setting development. The MAP
also supported the use of the quality
measure the Percent of Residents or
Patients with Pressure Ulcers that are
New or Worsened (Short Stay) (NQF
#0678) in the SNF QRP as a cross-setting
quality measure.
We proposed that the data for this
quality measure would be collected
using the MDS 3.0, currently submitted
by SNFs through the Quality
Improvement and Evaluation System
(QIES) Assessment Submission and
Processing (ASAP) system. We believe
that this data collection method will
minimize the reporting burden on SNFs
because SNFs are already required to
submit MDS data for multiple purposes,
such as for payment purposes. For more
information on SNF submission using
the QIES ASAP system, readers are
referred to https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/NursingHome
QualityInits/NHQIMDS30Technical
Information.html.
The data items that we proposed to
calculate the quality measure, the
Percent of Residents or Patients with
Pressure Ulcers that are New or
Worsened (Short Stay) (NQF #0678)
include: M0800A (Worsening in
Pressure Ulcer Status Since Prior
Assessment (OBRA or scheduled PPS
assessment) or Last Admission/Entry or
Reentry, Stage 2), M0800B (Worsening
in Pressure Ulcer Status Since Prior
Assessment (OBRA or scheduled PPS
assessment) or Last Admission/Entry or
Reentry, Stage 3), and M0800C
(Worsening in Pressure Ulcer Status
Since Prior Assessment (OBRA or
scheduled PPS assessment) or Last
Admission/Entry or Reentry, Stage 4).
This measure would be calculated at
two points in time, at admission and
discharge (see Form, Manner, and
Timing of Quality Data Submission).
The specifications and data items for the
quality measure, the Percent of
Residents or Patients with Pressure
Ulcers that are New or Worsened (Short
Stay) (NQF #0678) are available in the
MDS 3.0 Quality Measures User’s
Manual available on our Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
NHQIQualityMeasures.html.
We invited public comments on our
proposal to adopt the Percent of
Residents or Patients with Pressure
Ulcers that are New or Worsened (Short
Stay) (NQF #0678) for the SNF QRP for
the FY 2018 payment determination and
subsequent years. The following is a
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summary of the comments received and
our responses.
Comment: We received many
comments in support of our proposal to
implement the Percent of Residents or
Patients with Pressure Ulcers that are
New or Worsened quality measure
(Short Stay) (NQF #0678) to fulfill the
requirements of the IMPACT Act.
Commenters believed that measuring
skin integrity and changes in skin
integrity is important in the post-acute
care setting and appreciated that the
pressure ulcer measure is NQF-endorsed
and is already collected for the Nursing
Home Quality Initiative using the MDS
3.0 data.
Response: We thank the commenters
for their support of the Percent of
Residents or Patients with Pressure
Ulcers that are New or Worsened (Short
Stay) (NQF #0678) to fulfill the
requirements of the IMPACT Act. We
agree that skin integrity and changes in
skin integrity are high priority issues for
PAC settings.
Comment: One commenter supported
our proposal to use the MDS 3.0 as the
source of data collection for this
measure and to have SNFs submit the
data via the QIES ASAP system.
Response: We thank the commenter
for its support of the use of the MDS 3.0
and the QIES ASAP system for data
collection and reporting of the pressure
ulcer measure. The ongoing use of the
MDS 3.0 and the QIES ASAP system
will minimize burden for SNFs.
Comment: Several commenters were
supportive of the intent of this measure
but provided recommendations
regarding risk adjustment of the
pressure ulcer measure. Commenters
highlighted the importance of risk
adjusting all quality measures and
expressed concern that the measure may
not be risk adjusted appropriately for
the diverse populations across PAC
settings. The commenters encouraged
CMS to engage in ongoing evaluation of
the risk adjustment methodology used
for this measure to ensure that the
methodology is appropriate for standard
cross-setting risk adjustment, as the
current risk adjustment methodology is
based on data collection tools specific to
each PAC setting. Commenters
recommended that CMS add several
different risk factors to the risk
adjustment model including: primary
diagnosis; impairments; demographics;
co-existing conditions/comorbidities;
decreased sensory awareness; and
patients or residents at the end of life.
Commenters also encouraged CMS to
ensure that the measure is fully tested
prior to implementation in the QRPs.
One commenter was concerned that
the measure is limited to only high risk
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patients or residents, and that the
denominator size is decreased by
excluding individuals who are low risk.
The commenter indicated that pressure
ulcers do develop in low risk
individuals and that this exclusion will
impact each PAC setting differently
because the prevalence of low risk
individuals varies across settings. The
commenter recommended that CMS use
a logistic regression model for risk
adjustment to allow for an increase in
the measure sample size by including
all admissions, take into consideration
low volume providers, and capture the
development of pressure ulcers in low
risk individuals. The commenter
suggested that a patient or resident’s
risk is not dichotomous (for example,
high risk vs. low risk) and
recommended that CMS grade risk using
an ordinal scale related to an increasing
number and severity of risk factors. The
commenter also expressed that the
populations and types of risk for
pressure ulcers varies significantly
across PAC settings, and that using a
logistic regression model would be a
more robust way to include a wide
range of risk factors to better reflect the
population across PAC settings. The
commenter noted that the TEP that
evaluated this cross-setting pressure
ulcer measure also recommended that
CMS consider expanding the risk
adjustment model and discussed
excluding or risk adjusting for hospice
patients and those at the end of life.
Response: We thank the commenters
for their support of the intent of this
measure and for their recommendations
regarding risk adjustment for this
measure. Section 1899B(c)(3)(B) of the
Act states that quality measures shall be
risk adjusted, as determined appropriate
by the Secretary. In regards to the
commenter who recommended we risk
adjust using a logistic regression model
and incorporate low risk patients into
the measure, we believe that this
commenter may have submitted
comments regarding the wrong quality
measure. Their comments apply to the
quality measure Percent of High Risk
Residents with Pressure Ulcers (Long
Stay) (NQF #0679), which is not the
measure that we proposed for the SNF
QRP. The proposed measure is the
Percent of Residents or Patients with
Pressure Ulcers that are New or
Worsened (NQF #0678). This measure is
currently risk adjusted using a logistic
regression model and includes low risk
residents. In the model, patients or
residents are categorized as either high
or low risk based on four risk factors: (1)
Functional limitation; (2) bowel
incontinence; (3) diabetes or peripheral
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vascular disease/peripheral arterial
disease; and (4) low body mass index
(BMI). An expected score is calculated
for each patient or resident using that
patient or resident’s risk level on the
four risk factors described above. The
patient/resident-level expected scores
are then averaged to calculate the
facility-level expected score, which is
compared to the facility-level observed
score to calculate the adjusted score for
each facility. Additional detail regarding
risk adjustment for this measure is
available in the measure specifications,
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
NursingHomeQualityInits/SNF-QualityReporting-Program-Measures-andTechnical-Information.html.
When developing the risk adjustment
model for this measure, we reviewed the
literature, conducted analyses to test
additional risk factors, convened TEPs
to seek stakeholder input, and obtained
clinical guidance from subject matter
experts and other stakeholders to
identify additional risk factors. We have
determined that risk adjustment is
appropriate for this measure. Therefore,
we have developed and implemented
the risk adjustment model using the risk
factors described above. Nonetheless,
we will continue to analyze this
measure as more data is collected and
will consider changing the risk
adjustment model, expanding the risk
stratifications, and testing the inclusion
of other risk factors as additional risk
adjustors for future iterations of the
measure. We will also take into
consideration the TEP discussion and
the commenter’s feedback regarding the
exclusion or risk adjustment for hospice
patients and those at the end of life. As
we transition to standardized data
collection across PAC settings to meet
the mandate of the IMPACT Act, we
intend to continue our ongoing measure
development and refinement activities
to inform the ongoing evaluation of risk
adjustment models and methodology.
This continued refinement of the risk
adjustment models will ensure that the
measure remains valid and reliable to
inform quality improvement within and
across each PAC setting, and to fulfill
the public reporting goals of QRPs,
including the SNF QRP.
Comment: One commenter requested
that CMS consider risk adjusting the
quality measure for sociodemographic
status, to better reflect the realities that
affect the care of special populations
and the need for coordination with
hospitals within a geographic region.
The commenter suggested that some
beneficiaries in certain populations are
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46435
more complex, and therefore, their skin
integrity may be compromised.
Response: While we appreciate these
comments and the importance of the
role that sociodemographic status plays
in the care of patients, we continue to
have concerns about holding providers
to different standards for the outcomes
of their patients of low
sociodemographic status because we do
not want to mask potential disparities or
minimize incentives to improve the
outcomes of disadvantaged populations.
We routinely monitor the impact of
sociodemographic status on facilities’
results on our measures.
NQF is currently undertaking a 2-year
trial period in which new measures and
measures undergoing maintenance
review will be assessed to determine if
risk-adjusting for sociodemographic
factors is appropriate for each measure.
For 2 years, NQF will conduct a trial of
a temporary policy change that will
allow inclusion of sociodemographic
factors in the risk-adjustment approach
for some performance measures. At the
conclusion of the trial, NQF will
determine whether to make this policy
change permanent. Measure developers
must submit information such as
analyses and interpretations as well as
performance scores with and without
sociodemographic factors in the risk
adjustment model.
Furthermore, the Office of the
Assistant Secretary for Planning and
Evaluation (ASPE) is conducting
research to examine the impact of
socioeconomic status on quality
measures, resource use, and other
measures under the Medicare program
as directed by the IMPACT Act. We will
closely examine the findings of these
reports and related Secretarial
recommendations and consider how
they apply to our quality programs at
such time as they are available.
Comment: One commenter expressed
concerns that although the MAP
supports the cross-setting use of this
measure, it is only NQF endorsed for the
SNF setting and suggested that CMS
delay implementing the cross-setting
measure until it is NQF endorsed across
all PAC settings. The commenter also
pointed out that the specifications
available on the NQF Web site are dated
October 2013.
Response: Although the proposed
pressure ulcer measure was originally
developed for the SNF/nursing home
resident population, it has been respecified for the LTCH and IRF settings,
underwent review for expansion to the
LTCH and IRF settings by the NQF
Consensus Standards Approval
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Committee (CSAC) on July 11, 2012 38
and was subsequently ratified by the
NQF Board of Directors for expansion to
the LTCH and IRF settings on August 1,
2012.39 As reflected on the NQF Web
site the endorsed settings for this
measure include Post-Acute/Long Term
Care Facility: Inpatient Rehabilitation
Facility, Post Acute/Long Term Care
Facility: Long Term Acute Care
Hospital, Post Acute/Long Term Care
Facility: Nursing Home/Skilled Nursing
Facility.40 NQF endorsement of this
measure indicates that NQF supports
the use of this measure in the LTCH and
IRF settings, as well as in the SNF
setting. As one commenter indicated,
this measure was fully supported by the
MAP for cross-setting use at its meeting
of February 9, 2015. With regard to the
measure specifications posted on the
NQF Web site, the most up-to-date
version of the measure specifications
were posted for stakeholder review at
the time of the proposed rule on the
CMS Web site at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
NursingHomeQualityInits/Downloads/
Skilled-Nursing-Facility-QualityReporting-Program-Quality-MeasureSpecifications-for-FY-2016-Notice-ofProposed-Rule-Making-report.pdf. The
specifications currently posted on the
NQF Web site are computationally
equivalent and have the same measure
components as those posted on the CMS
Web site at the time of the proposed
rule. However, we provided more detail
in the specifications posted with the
proposed rule, in an effort to more
clearly explain aspects of the measure
that were not as clear in the NQF
specifications. Additionally, we
clarified language to make phrasing
more parallel across settings, and
updated item numbers and labels to
match the 2016 data sets (MDS 3.0,
LTCH CARE Data Sets, and IRF–PAI).
We are working closely with NQF to
make updates and ensure that the most
current language and clearest version of
the specifications are available on the
NQF Web site.
Comment: A few commenters
expressed concern regarding the
38 Nation Quality Forum, Consensus
Standardbreds Approval Committee. Meeting
Minutes, July 11, 2012. 479–489.
39 National Quality Forum. NQF Removes TimeLimited Endorsement for 13 Measures; Measures
Now Have Endorsed Status. August 1, 2012.
Available; https://www.qualityforum.org/News_And_
Resources/Press_Releases/2012/NQF_Removes_
Time-Limited_Endorsement_for_13_Measures;_
Measures_Now_Have_Endorsed_Status.aspx.
40 National Quality Forum. Percent of Residents
or Patients with Pressure Ulcers that are New or
Worsened (Short-Stay). Available: https://
www.qualityforum.org/QPS/0678.
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reliability and validity of this measure
across different PAC settings. The
commenters were concerned that the
reliability and validity testing for this
measure was only conducted in the SNF
setting.
Response: Although this measure was
originally developed for the SNF setting,
the NQF expanded its endorsement of
the measure to the IRF and LTCH
settings as a cross setting quality
measure in 2012, and the expanded
measure was finalized in the FY 2014
IRF PPS final rule (78 FR 47911 through
47912) and the FY 2014 IPPS/LTCH PPS
final rule (78 FR 50861 through 50863).
As part of quality measure maintenance
for this quality measure, we and our
measure contractor will continue to
perform reliability and validity testing.
Early data analyses have shown that
data continues to be valid and reliable.
We appreciate the commenters’
concern that the SNF, LTCH, and IRF
populations are not identical and that
some differences may exist in the
reliability and validity of the measure
across settings. We are working towards
standardizing data across PAC settings
as mandated in the IMPACT Act. As
such, we continue to conduct measure
development and testing to explore the
best way to standardize quality
measures, while ensuring reliability and
validity for the measures to
appropriately account for the unique
differences in populations across PAC
settings.
Comment: Several commenters were
concerned that the pressure ulcer
measure is not standardized across PAC
settings. The commenters stated that
although the measure appears meets the
goals and the intent of the IMPACT Act,
it does not use a single data assessment
tool.
One commenter specifically
mentioned the frequency of
assessments, highlighting the fact that
the LTCH and IRF versions of the
measure are calculated using two
assessment time-points (admission and
discharge), while the SNF version uses
multiple assessment time-points. The
commenter expressed concern that the
higher frequency of assessments for the
MDS could potentially result in higher
rates of pressure ulcer counts for SNFs.
Another commenter voiced particular
concerns regarding differences in the
look-back periods, for the items used on
the IRF, SNF, and LTCH assessments
(MDS=7-day assessment period, IRF=3day assessment period, LTCH = 3-day
assessment period) and suggested that
this would result in different rates of
detection of new or worsened ulcers.
Commenters encouraged CMS to
address all of these discrepancies, and
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suggested that we should switch to
using only an admission and discharge
assessment in the SNF version of the
measure.
Response: We appreciate the
commenters’ review of the measure
specifications across the post-acute care
settings. We wish to clarify that while
the IMPACT Act requires the
modification of PAC assessment
instruments to revise or replace certain
existing patient assessment data with
standardized patient assessment data as
soon as practicable, it does not require
a single data collection tool. We intend
to modify the existing PAC assessment
instruments as soon as practicable to
ensure the collection of standardized
data. While we agree that it is possible
that within the PAC assessment
instruments certain sections could
incorporate a standardized assessment
data collection tool, for example, the
Brief Interview for Mental Status
(BIMS), we have not yet concluded that
this kind of modification of the PAC
assessment instruments is necessary.
As to the concern that the pressure
ulcer measure calculation is based on
more frequent assessments in the SNF
setting than in the LTCH and IRF
settings, we wish to clarify that result of
the measure calculation for all three
PAC providers is the same. For all three
PAC providers, the measure calculation
ultimately shows the difference between
the number of pressure ulcers present
on admission and the number of new or
worsened pressure ulcers present on
discharge. While SNF measure
calculation arrives at that number
differently than does the measure
calculation in the IRF and LTCH
settings, ultimately all three settings
report the same result—as noted, the
difference between the number of
pressure ulcers present on admission
and the new or worsened pressure
ulcers at discharge. To explain, in IRFs
and LTCHs, pressure ulcer assessment
data is obtained only at two points in
time—on admission and on discharge.
Therefore, the calculation of the
measure includes all new or worsened
pressure ulcers since admission. In
contrast, in SNFs pressure ulcer
assessment data is obtained on
admission, at intervals during the stay
(referred to as ‘‘interim assessments’’),
and at discharge. Each interim
assessment and the discharge
assessment only look back to whether
there were new or worsened pressure
ulcers since the last interim assessment.
The sum of number of new or worsened
pressure ulcers identified at each
interim assessment and at the time of
discharge yields the total number of
new or worsened pressure ulcers that
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occurred during the stay and that were
present on discharge. In other words,
the collection of pressure ulcer data in
LTCHs and IRFs is cumulative, whereas
in SNFs, data collection is sequential. In
both cases the calculation reaches the
same result—the total number of new or
worsened pressured ulcers between
admission and discharge. Thus, this is
the same result of the measure
calculation for SNFs as is obtained for
IRFs and LTCHs. With respect to the
commenter’s concern that the use of
interim assessment periods on the MDS
will result in a higher frequency of
pressure ulcers for SNF residents, we
clarify that pressure ulcers found during
interim assessments that heal before
discharge are not included in the
measure calculation.
In regards to the commenter’s concern
about different look-back periods, we
acknowledge that although the LTCH
CARE Data Set and IRF–PAI allow up to
the third day starting on the day of
admission as the assessment period and
the MDS allows for an assessment
period of admission up to day 7, we
note that the training manuals for SNFs,
LTCHs and IRFs provide specific and
equivalent-coding instructions related to
the items used to calculate this measure
(found in Section M—skin conditions
for all three assessments). These
instructions ensure that the assessment
of skin integrity occurs at the initiation
of patients’ or residents’ PAC stays
regardless of setting. All three manuals
direct providers to complete the skin
assessment for pressure ulcers present
on admission as close to admission as
possible, ensuring a harmonized
approach to the timing of the initial skin
assessment. Regardless of differences in
the allowed assessment periods,
providers across PAC settings should
adhere to best clinical practices,
established standards of care, and the
instructions in their respective training
manuals, to ensure that skin integrity
information is collected as close to
admission as possible. Although the
manual instructions are harmonized to
ensure assessment at the beginning of
the stay, based on the commenter’s
feedback, we will take into
consideration the incorporation of
uniform assessment periods for this
section of the assessments.
Comment: Commenters expressed
concerns about the pressure ulcer
measure not being standardized across
PAC settings, specifically noting
differences in the payers that are
required to report patient or resident
data for this measure resulting in
differences in the denominators for each
setting. Commenters also expressed
concern with the exclusion of Medicare
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Advantage beneficiaries from the
numerator and denominator for this
measure. One commenter noted that
measures based on only Medicare FFS
beneficiaries may be incomplete,
because according to some estimates,
only about half of SNF residents are
covered by Medicare FFS.
In a related comment, a commenter
expressed concern regarding differences
in the populations across quality
measures in the SNF QRP. The
commenters stated that the falls
measure (NQF #0674) and function
measure (NQF #2631) include only
Medicare FFS residents, while the
pressure ulcer measure (NQF #0678)
includes all short-stay NH residents.
The commenter mentioned that this
inconsistency could result in confusion
for providers because of the varying
denominators across measures.
Response: We appreciate the
commenters’ comments pertaining to
the differences in the pressure ulcer
quality measure denominators by payer
type across the IRF, SNF and LTCH
settings. Additionally, we appreciate the
commenters’ suggested expansion of the
population used to calculate all
measures to include payer sources
beyond Medicare PPS Part A and agree
that quality measures that include all
persons treated in a facility are better
able to capture the health outcomes of
that facility’s patients or residents, and
that quality reporting on all patients or
residents is a worthy goal. Although we
currently collect data only on the SNF
and the IRF Medicare populations, we
believe that quality care is best assessed
through the collection of patient data
regardless of payer source and we agree
that consistency in the data would
reduce confusion in data interpretation
and enable a more comprehensive
evaluation of quality. We appreciate the
commenter’s concerns and although we
had not proposed all payer data
collection through this current
rulemaking, we will take into
consideration the expansion of the SNF
QRP to include all payer sources
through future rulemaking.
Comment: One commenter asked
CMS to clarify how the addition of the
proposed SNF PPS Part A Discharge
Assessment will impact the measure
specifications for the numerator and
denominator of the pressure ulcer
measure. The commenter noted that
CMS proposed modifying the MDS
discharge assessment to collect
information for Part A FFS Medicare
beneficiaries who continue in the SNF
after ending their Part A stay, but did
not clarify how this change will be
implemented in the proposed pressure
ulcer measure. The commenter is
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46437
concerned that if the new MDS
discharge assessment is not modified to
add the pressure ulcer measure
assessment items, the measure will
exclude individuals who are admitted
but not discharged from the SNF during
their PAC stay, which will limit CMS’s
ability to provide meaningful
information to provider and consumers.
Finally the commenter expressed
concern regarding the increase in
burden that will be required to complete
this assessment, and encouraged CMS to
only include the minimum information
necessary to calculate the quality
measures.
Response: We proposed that the SNF
PPS Part A Discharge Assessment would
include the pressure ulcer data elements
for the quality measure, the Percent of
Residents or Patients with Pressure
Ulcers that are New or Worsened (Short
stay) (NQF #0678), in order to capture
complete pressure ulcer information for
Medicare beneficiaries who continue in
the SNF after the end of a Part A stay
(–all information between admission
and discharge or end of a Part A stay).
For more information on the Part A PPS
Discharge assessment, we direct readers
to the specifications posted on the SNF
QRP Measures and Technical
Information Web site, at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting-ProgramMeasures-and-TechnicalInformation.html.
Comment: Many commenters
expressed concern with the accuracy of
data used to calculate the pressure ulcer
measure. One commenter was
specifically concerned that CMS
excludes residents or patients for whom
missing data precludes calculation of
the measure from the measure
calculations. The commenter expressed
that this exclusion may lead to
miscoding because if a facility
recognizes that a resident is declining,
it can simply omit some data for that
resident, ensuring that the resident is
excluded from the measure. The
commenter referenced several different
media reports that highlight the
seriousness of gaming of MDS 3.0 data.
One commenter noted a recent survey
that identified deficiencies in reporting
by a small sample of SNFs.
Response: As discussed below, we are
finalizing our proposal that beginning
with the FY 2018 payment
determination, any SNF that does not
meet the requirement that 80 percent of
all MDS assessments submitted contain
100 percent of all data items necessary
to calculate the SNF QRP measures
would be subject to a reduction of 2
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percentage points to its FY 2018 market
basket percentage. This requirement
will provide an incentive to SNFs to
submit complete MDS 3.0 assessments.
Analysis of 2014 MDS 3.0 data
submitted for the NHQI indicates that
for each of the three items used to
calculate the pressure ulcer measure
(M0800A, M0800B, and M0800C),
missing data for calculating measures
were approximately 0.1 percent across
all target assessments in a given quarter.
Less than 0.1 percent of residents were
excluded due to missing all three items
needed to calculate the measure,
suggesting that missing data is not a
serious concern. Further, we intend to
align with other QRPs and propose
through future rulemaking a data
validation process that will further
ensure that data reported for the SNF
QRP is accurate and complete.
Comment: One commenter asked
CMS to clarify whether the pressure
ulcer measure proposed for the SNF
QRP can be reported using the current
MDS 3.0 pressure ulcer items, or if new
items would be required for this
measure. The commenter asked if SNFs
would be required to submit different
data for the SNF QRP and the Nursing
Home Quality Initiative.
Response: The proposed pressure
ulcer measure is the same measure that
nursing homes have been reporting for
short stay residents through CMS’s
Nursing Home Quality Initiative since
2010. The items used to calculate the
measure are the same in the SNF QRP
and the Nursing Home Quality
Initiative. SNFs will only be required to
submit data for this measure once to
fulfill the requirements of both
programs.
Comment: One commenter was
concerned that the MDS 3.0 data does
not adequately capture multiple
pressure ulcers and presence at
admission for each wound. The
commenter was concerned that this
could result in confusion for SNFs as
they may lose track of which ulcers
were present on admission and which
are new or worsened, resulting in
inaccurate counts in the quality
measure.
Response: The MDS 3.0 does not
require SNF providers to provide
individual tracking information for each
pressure ulcer. However, we note that
the MDS does not replace standard
clinical practice. We expect that all
SNFs are conducting comprehensive
skin assessments throughout the stay
and documenting all of the necessary
information to fully prevent and manage
pressure ulcers for all residents. As such
SNFs are able to utilize the data they
collect as part of standard clinical
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practice to track and manage pressure
ulcers, in order to complete the MDS 3.0
items related to the improvement and
worsening of pressure ulcers during the
resident’s Part A covered stay in the
facility.
Comment: One commenter did not
support the proposed measure, the
Percent of Residents or Patients with
Pressure Ulcers that are New or
Worsened (Short Stay) (NQF #0678).
The commenter was concerned that the
measure timeframe is too short to
properly capture pressure ulcer
improvement, disadvantaging facilities
that serve more frail populations. The
commenter indicated that capturing a
healed pressure ulcer is particularly
difficult as SNFs have a very limited
amount of time from admission to the
end of a short-stay episode to heal a
pressure ulcer.
Response: We would like to clarify
that the proposed quality measure
assesses the percent of residents or
patients with Stage 2–4 pressure ulcers
that are new or worsened since the prior
assessment, and does not focus on
capturing the improvement of pressure
ulcers. This measure specifies that if a
pressure ulcer is present on admission
and worsened during the stay, it would
be included in the numerator. Further,
if the pressure ulcer is present on
admission, and did not worsen during
the stay, it would not be included in the
numerator. We agree with the
commenter that the timeframe is often
too short to heal pressure ulcers
amongst the frail and elderly
population; therefore the measure does
not capture information about healed
pressure ulcers. Rather, the intent of the
measure is to hold providers
accountable for preventing the
worsening of or onset of new pressure
ulcers.
Comment: One commenter expressed
concern that SNFs with a sub-acute unit
will be at risk for reporting higher
percentages of residents or patients with
pressure ulcers than SNFs that do not
have a designated sub-acute unit under
the proposed measure.
Response: We agree that some SNF
residents are at higher risk for
developing new or worsened pressure
ulcers. However, pressure ulcers are
severe, life threatening, and high-cost
adverse events, and many SNF residents
may have medically complex conditions
that put them at high risk for the
development or worsening of pressure
ulcers. Given their impact on mortality,
morbidity, and quality of life, we
believe that SNFs should be responsible
for preventing and managing pressure
ulcers among both high and low risk
residents or patients and that facilities
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with certain types of patients should not
be exempt from reporting new or
worsened pressure ulcers. In effort to
account for the added challenges that
facilities with more high risk residents
may face, the proposed quality measure
is risk adjusted for four risk factors: (1)
Functional limitation, (2) bowel
incontinence, (3) diabetes or peripheral
vascular disease/peripheral arterial
disease, and (4) low body mass index
(BMI).
Comment: Many commenters
encouraged CMS to align measures
where possible with existing CMS
initiatives, across settings, and
payments types.
Response: We strive to harmonize and
align quality measures across initiatives,
settings, and payment types whenever
possible and will continue to do so as
we develop and implement quality
measures under the IMPACT Act.
Final Decision: Having carefully
considered the comments we received
on the quality measure, the Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short Stay) (NQF #0678), we are
finalizing the adoption of this measure
for use in the SNF QRP.
As part of our ongoing measure
development efforts, we are considering
a future update to the numerator of the
quality measure, the Percent of
Residents or Patients with Pressure
Ulcers that are New or Worsened (Short
Stay) (NQF #0678). This update would
require PAC providers to report the
development of unstageable pressure
ulcers, including suspected deep tissue
injuries (sDTIs). Under this potential
change we are considering, the
numerator of the quality measure would
be updated to include unstageable
pressure ulcers, including sDTIs that are
new/developed in the facility, as well as
Stage 1 or 2 pressure ulcers that become
unstageable due to slough or eschar
(indicating progression to a stage 3 or 4
pressure ulcer) after admission. SNFs
are already required to complete the
unstageable pressure ulcer items on the
MDS 3.0. As such, this update would
require a change in the way the measure
is calculated but would not increase the
data collection burden for SNFs.
A TEP convened by our measure
development contractor strongly
recommended that CMS update the
specifications for the measure to include
these pressure ulcers in the numerator,
although it acknowledged that
unstageable pressure ulcers and sDTIs
cannot and should not be assigned a
numeric stage. The TEP also
recommended that a Stage 1 or 2
pressure ulcer that becomes unstageable
due to slough or eschar should be
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tkelley on DSK3SPTVN1PROD with RULES2
considered worsened because the
presence of slough or eschar indicates a
full thickness (equivalent to Stage 3 or
4) wound.41 42 These recommendations
were supported by technical and
clinical advisors and the National
Pressure Ulcer Advisory Panel.43
Additionally, exploratory data analysis
conducted by our measure development
contractor suggests that the addition of
unstageable pressure ulcers, including
sDTIs, will increase the observed
incidence of new or worsened pressure
ulcers at the facility level and may
improve the ability of the quality
measure to discriminate between poorand high-performing facilities.
We invited public comments to
inform our consideration of the
inclusion of unstageable pressure ulcers,
including sDTIs in the numerator of the
quality measure, the Percent of
Residents or Patients with Pressure
Ulcers that are New or Worsened (Short
Stay) (NQF #0678) as part of our future
measure development efforts. The
following is a summary of the comments
received and our responses.
Comment: One commenter supported
our proposal to include unstageable
pressure ulcers and suspected deep
tissue injuries in the numerator of the
proposed quality measure as an area for
future measure development. The
commenter agreed that these cases
should be included in the measure
population.
Response: As noted, the
recommendation addresses an
important clinical concern, and may
41 Schwartz, M., Nguyen, K.H., Swinson Evans,
T.M., Ignaczak, M.K., Thaker, S., and Bernard, S.L.:
Development of a Cross-Setting Quality Measure for
Pressure Ulcers: OY2 Information Gathering, Final
Report. Centers for Medicare & Medicaid Services,
November 2013. Available: https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-Quality-Initiatives/
Downloads/Development-of-a-Cross-SettingQuality-Measure-for-Pressure-Ulcers-InformationGathering-Final-Report.pdf.
42 Schwartz, M., Ignaczak, M.K., Swinson Evans,
T.M., Thaker, S., and Smith, L.: The Development
of a Cross-Setting Pressure Ulcer Quality Measure:
Summary Report on November 15, 2013, Technical
Expert Panel Follow-Up Webinar. Centers for
Medicare & Medicaid Services, January 2014.
Available: https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/PostAcute-Care-Quality-Initiatives/Downloads/
Development-of-a-Cross-Setting-Pressure-UlcerQuality-Measure-Summary-Report-on-November15-2013-Technical-Expert-Pa.pdf.
43 Schwartz, M., Nguyen, K.H., Swinson Evans,
T.M., Ignaczak, M.K., Thaker, S., and Bernard, S.L.:
Development of a Cross-Setting Quality Measure for
Pressure Ulcers: OY2 Information Gathering, Final
Report. Centers for Medicare & Medicaid Services,
November 2013. Available: https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-Quality-Initiatives/
Downloads/Development-of-a-Cross-SettingQuality-Measure-for-Pressure-Ulcers-InformationGathering-Final-Report.pdf.
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improve the ability of the quality
measure to discriminate between poor
and high-performing facilities. As we
consider the possibility of adding
unstageable pressure ulcers and
suspected deep tissue injuries to the
numerator, we will carefully consider
all comments received from
stakeholders.
Comment: Several commenters were
supportive of our proposal to include
unstageable pressure ulcers (we
interpret their comment as referring to
unstageable pressure ulcers due to
slough or eschar and due to nonremovable dressing/device) in the
numerator of the quality measure as an
area for future measure development,
but expressed reservations about the
possible future inclusion of suspected
deep tissue injuries (sDTIs) in the
numerator of the Percent of Residents or
Patients with Pressure Ulcers That Are
New or Worsened (Short Stay) (NQF
#0678) quality measure. Commenters
cited information from the National
Pressure Ulcer Advisory Council
suggesting that sDTIs can take between
72 hours and seven days to become
visible, indicating that there is no
reliable and consistent way to determine
whether an sDTI at admission is facility
acquired or not. Commenters also
mentioned confusion surrounding
pressure ulcers that are unavoidable or
times when prevention is not possible.
Finally, multiple commenters stated
that the time frame during which sDTIs
become visible varies and there is
potential for miscoding, both of which
may make this an unreliable quality
measure.
One commenter requested more
information about how this change
would be incorporated into the measure
specifications. The commenter also
requested more information regarding
the impact this change would have on
the reliability and validity of the
measure, as well as how it may impact
the risk adjustment methodology.
Finally the commenter encouraged CMS
to submit any proposed changes through
NQF review and specify all details in
future rule making. Commenters also
encouraged CMS to update the coding
instructions for the RAI manual if this
change is made, apply this change
across all PAC settings, and gather
additional stakeholder and expert input
on this change prior to implementation.
Response: We appreciate the
recommendations regarding the
approach to future implementation. We
will continue to conduct analyses and
solicit input before making any final
decisions regarding this possible change
to the measure specifications. We intend
to continue monitoring the literature,
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46439
conduct reliability and validity testing,
seek input from subject matter experts
and stakeholders, and participate in
ongoing refinement activities to inform
this measure before proposing to adopt
any changes. Should we move forward
with the addition of unstageable and
sDTIs to the measure numerator, we
intend to submit any changes through
NQF, provide information that will
allow providers to accurately interpret
and complete quality reporting items,
ensure that the MDS 3.0 Resident
Assessment Instrument Manual and
training materials provide accurate and
up-to-date coding instructions for all
items, and seek public comment on
future measure concepts or revisions.
In regard to the commenters’ concerns
regarding sDTIs, we believe that it is
important to do a thorough admission
assessment on each resident or patient
who is admitted to a SNF, including a
thorough skin assessment documenting
the presence of any pressure ulcers of
any kind—including sDTIs. When
considering the addition of sDTIs to the
measure numerator, we convened crosssetting TEPs in June and November
2013, and obtained input from
clinicians, experts, and other
stakeholders. While we agree that
ongoing research is needed, sDTIs are a
serious medical condition and given
their potential impact on mortality,
morbidity, and quality of life, it may be
detrimental to the quality of care to
exclude them from future quality
measures. We thank the commenters for
their feedback and we will take into
account the recommendations regarding
the challenges in determining whether
an sDTI at admission is facility acquired
or not, the difficulty in coding sDTIs,
and the confusion surrounding pressure
ulcers that are unavoidable or times
when prevention is not possible.
Comment: One commenter did not
support the addition of unstageable
pressure ulcers in the numerator of the
Percent of Residents or Patients with
Pressure Ulcers That Are New or
Worsened (Short Stay) (NQF #0678)
quality measure. The commenter was
concerned that the measure timeframe is
too short to properly capture pressure
ulcer improvement, disadvantaging
facilities that serve more frail
populations. The commenter indicated
that capturing a healed unstageable
pressure ulcer is particularly difficult as
SNFs have a very limited amount of
time from admission to the end of a
short-stay episode to heal a pressure
ulcer.
Response: We will take all
stakeholder feedback into account as we
consider the possibility of including
unstageable pressure ulcers, including
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sDTIs in the numerator of the quality
measure in the future.
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(2) Quality Measure Addressing the
Domain of the Incidence of Major Falls:
An Application of the Measure Percent
of Residents Experiencing One or More
Falls with Major Injury (Long Stay)
(NQF #0674)
We proposed to adopt beginning with
the FY 2018 SNF QRP, an application to
the SNF setting of the Percent of
Residents Experiencing One or More
Falls with Major Injury (Long Stay)
(NQF #0674) measure that satisfies the
incidence of major falls domain. This
outcome measure reports the percentage
of residents who have experienced falls
with major injury during episodes
ending in a 3-month period. This
measure was developed by CMS and is
NQF-endorsed for long-stay residents of
NFs.
Research indicates that fall-related
injuries are the most common cause of
accidental death in people aged 65 and
older, responsible for approximately 41
percent of accidental deaths annually.44
Rates increase to 70 percent of
accidental deaths among individuals
aged 75 and older.45 In addition to
death, falls can lead to fracture, soft
tissue or head injury, fear of falling,
anxiety, and depression.46 Research also
indicates that approximately 75 percent
of nursing facility residents fall at least
once a year. This is twice the rate of
their counterparts in the community.47
Further, it is estimated that 10 percent
to 25 percent of nursing facility resident
falls result in fractures and/or
hospitalization.48
Falls also represent a significant cost
burden to the entire health care system,
with injurious falls accounting for 6
percent of medical expenses among
those age 65 and older.49 In one study,
Sorensen et al. estimated the costs
associated with falls of varying severity
among nursing home residents.50 Their
44 Currie LM. Fall and injury prevention. Annu
Rev Nurs Res. 2006;24:39–74.
45 Fuller GF. Falls in the elderly. Am Fam
Physician. Apr 1 2000;61(7):2159–2168, 2173–2154.
46 Love K, Allen J. Falls: why they matter and
what you can do. Geriatr Nurs, 2011; 32(3): 206–
208.
47 Rubenstein LZ, Josephson KR, Robbins AS.
Falls in the nursing home. Ann Intern Med. 1994
Sep 15; 121(6):442–51.
48 Vu MQ, Weintraub N, Rubenstein LZ. Falls in
the nursing home: are they preventable? J Am Med
Dir Assoc. 2004 Nov-Dec; 5(6):401–6. Review.
49 Tinetti ME, Williams CS. The effect of falls and
fall injuries on functioning in community-dwelling
older persons. J Gerontol A Biol Sci Med Sci. 1998
Mar;53(2):M112–9.
50 Sorensen SV, de Lissovoy G, Kunaprayoon D,
Resnick B, Rupnow MF, Studenski S. A taxonomy
and economic consequence of nursing home falls.
Drugs Aging. 2006;23(3):251–62.
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work suggests that acute care costs
incurred for falls among nursing home
residents range from $979 for a typical
case with a simple fracture to $14,716
for a typical case with multiple injuries.
A similar study of hospitalizations of
nursing home residents due to serious
fall-related injuries (intracranial bleed,
hip fracture, other fracture) found an
average cost of $23,723.51 Among the
SNF population, the average 6-month
cost of a resident with a hip fracture was
estimated at $11,719 in 1996 U.S.
dollars.52
According to Morse, 78 percent of
falls are anticipated physiologic falls,
which are falls among individuals who
scored high on a risk assessment scale,
meaning their risk could have been
identified in advance of the fall.53 To
date, studies have identified a number
of risk factors for falls.54 55 56 57 58 59 60 61 62
The identification of such risk factors
suggests the potential for health care
facilities to reduce and prevent the
incidence of falls. The Percent of
Residents Experiencing One or More
Falls with Major Injury (Long Stay)
(NQF #0674) quality measure is NQF51 Quigley PA, Campbell RR, Bulat T, Olney RL,
Buerhaus P, Needleman J. Incidence and cost of
serious fall-related injuries in nursing homes. Clin
Nurs Res. Feb 2012;21(1):10–23.
52 Kramer AM, Steiner JF, Schlenker RE, et al.
Outcomes and costs after hip fracture and stroke:
a comparison of rehabilitation settings. JAMA.
1997;277(5):396–404.
53 Morse, J. M. (2002) Enhancing the safety of
hospitalization by reducing patient falls. Am J
Infect Control 2002; 30(6): 376–80.
54 Rothschild JM, Bates DW, Leape LL.
Preventable medical injuries in older patients. Arch
Intern Med. 2000 Oct 9; 160(18):2717–28.
55 Morris JN, Moore T, Jones R, et al. Validation
of long-term and post-acute care quality indicators.
CMS Contract No: 500–95–0062/T.O. #4.
Cambridge, MA: Abt Associates, Inc., June 2003.
56 Avidan AY, Fries BE, James ML, Szafara KL,
Wright GT, Chervin RD. Insomnia and hypnotic
use, recorded in the minimum data set, as
predictors of falls and hip fractures in Michigan
nursing homes. J Am Geriatr Soc. 2005 Jun;
53(6):955–62.
57 Fonad E, Wahlin TB, Winblad B, Emami A,
Sandmark H. Falls and fall risk among nursing
home residents. J Clin Nurs. 2008 Jan; 17(1):126–
34.
58 Currie LM. Fall and injury prevention. Annu
Rev Nurs Res. 2006; 24:39–74.
59 Ellis AA, Trent RB. Do the risks and
consequences of hospitalized fall injuries among
older adults in California vary by type of fall? J
Gerontol A Biol Sci Med Sci. Nov 2001;
56(11):M686–692.
60 Chen XL, Liu YH, Chan DK, Shen Q, Van
Nguyen H. Chin Med J (Engl). Characteristics
associated with falls among the elderly within aged
care wards in a tertiary hospital: a retrospective.
2010 Jul; 123(13):1668–72.
61 Frisina PG, Guellnitz R, Alverzo J. A time series
analysis of falls and injury in the inpatient
rehabilitation setting. Rehabil Nurs. 2010 JulAug;
35(4):141–6, 166.
62 Lee JE, Stokic DS. Risk factors for falls during
inpatient rehabilitant Am J Phys Med Rehabil. 2008
May; 87(5):341–50; quiz 351, 422.
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endorsed and has been successfully
implemented in the Nursing Home
Quality Initiative for nursing facility
long-stay residents since 2011. In
addition, the quality measure is
currently publicly reported on CMS’s
Nursing Home Compare Web site at
https://www.medicare.gov/
nursinghomecompare/search.html.
Further, an application of the quality
measure was adopted for use in the
LTCH QRP in the FY 2014 IPPS/LTCH
PPS final rule (78 FR 50874 through
50877). In the FY 2015 IPPS/LTCH PPS
final rule (79 FR 50290), we revised the
data collection period for this measure
with data collection to begin starting
April 1, 2016.
Although the quality measure, the
Percent of Residents Experiencing One
or More Falls with Major Injury (Long
Stay) (NQF #0674) is not currently
endorsed for the SNF setting, we
reviewed the NQF’s consensus endorsed
measures and were unable to identify
any NQF-endorsed cross-setting quality
measures for that setting that are
focused on falls with major injury. We
are aware of one NQF-endorsed
measure, Falls with Injury (NQF #0202),
which is a measure designed for adult
acute inpatient and rehabilitation
patients capturing ‘‘all documented
patient falls with an injury level of
minor or greater on eligible unit types
in a calendar quarter, reported as injury
falls per 100 days.’’ 63 NQF #0202 is not
appropriate to meet the IMPACT Act
domain as it includes minor injury in
the numerator definition. Additionally,
including all falls could result in
providers limiting the freedom of
activity for individuals at higher risk for
falls. We are unaware of any other crosssetting quality measures for falls with
major injury that have been endorsed or
adopted by another consensus
organization for the SNF setting.
Therefore, we proposed to adopt this
measure under the Secretary’s authority
to specify non-NQF-endorsed measures
under section 1899B(e)(2)(B) of the Act.
A TEP convened by our measure
development contractor provided input
on the technical specifications of an
application of the quality measure, the
Percent of Residents Experiencing One
or More Falls with Major Injury (Long
Stay) (NQF #0674), including the
feasibility of implementing the measure
across PAC settings. The TEP was
supportive of the implementation of this
measure across PAC settings and was
also supportive of our efforts to
standardize this measure for cross63 American Nurses Association (2014, April 9).
Falls with injury. Retrieved from https://
www.qualityforum.org/QPS/0202.
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setting development. The MAP
conditionally supported the use of an
application of the quality measure, the
Percent of Residents Experiencing One
or More Falls with Major Injury (Long
Stay) (NQF #0674) in the SNF QRP as
a cross-setting quality measure. More
information about the MAP’s
recommendations for this measure is
available in the report entitled MAP OffCycle Deliberations 2015: Measures
under Consideration to Implement
Provisions of the IMPACT Act are
available at https://
www.qualityforum.org/Project_Pages/
MAP_Post-Acute_CareLong-Term_Care_
Workgroup.aspx.
More information on the NQFendorsed quality measure, the Percent
of Residents Experiencing One or More
Falls with Major Injury (Long Stay)
(NQF #0674) is available at https://
www.qualityforum.org/QPS/0674.
We proposed that data for this quality
measure would be collected using the
MDS 3.0, currently submitted by SNFs
through the QIES ASAP system for the
reason noted previously.
The data items that we will use to
calculate this proposed quality measure
include: J1800 (Any Falls Since
Admission/Entry (OBRA or Scheduled
PPS) or Reentry or Prior Assessment,
whichever is more recent); and J1900
(Number of Falls Since Admission/
Entry (OBRA or Scheduled PPS) or
Reentry or Prior Assessment, whichever
is more recent). This measure will be
calculated at the time of discharge (see
Proposed Form, Manner, and Timing of
Quality Data Submission). The
specifications for an application of the
quality measure, the Percent of
Residents Experiencing One or More
Falls with Major Injury (Long Stay)
(NQF #0674) for the SNF population are
available on our SNF QRP measures and
technical Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting-ProgramMeasures-and-TechnicalInformation.html.
We referred readers to the Form,
Manner, and Timing of Quality Data
Submission section of the FY 2016 SNF
PPS proposed rule (79 FR 22076
through 22077) for more information on
the proposed data collection and
submission timeline for this proposed
quality measure.
We invited public comments on our
proposal to adopt an application of the
quality measure, the Percent of
Residents Experiencing One or More
Falls with Major Injury (Long Stay)
(NQF #0674) for the SNF QRP beginning
with the FY 2018 payment
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determination. The comments we
received on this topic, with their
responses, appear below.
Comment: Several commenters
supported our proposal to implement an
application of the quality measure, the
Percent of Residents Experiencing One
or More Falls with Major Injury (Long
Stay) (NQF #0674) to fulfill the
requirements of the IMPACT Act.
Response: We thank the commenters
for their support.
Comment: One commenter supported
measuring falls in SNFs, but stated a
preference for measuring falls ‘‘with or
without injury’’ and ‘‘assisted or nonassisted’’ and tracking by preventable
falls (resident-related or environmentand other-related) and non-preventable
(resident conditions like fainting).
Response: The proposed application
of the quality measure, the Percent of
Residents Experiencing One or More
Falls with Major Injury (Long Stay)
(NQF #0674) assesses falls with major
injuries, satisfying the domain in
section 1899B(c)(1)(D) of the Act, the
Incidence of Major Falls. We believe
this domain mandates a quality measure
related to falls with major injury. We
agree that a provider’s tracking of falls
is important for the purpose of ensuring
resident safety. The information
suggested by the commenter for
collection is already included in the
MDS 3.0 enabling SNFs to track all falls,
regardless of injury by including items
indicating the number of falls with and
without injury. The data elements used
to track all falls, including major injury,
J1800, J1900 A, B and C, are collected
to ensure the reliability of the data. We
note that Measure #0674 has been NQFendorsed based on the manner in which
it is calculated now, and its inter-rater
reliability is based on the data collection
of J1900 A, B and C. The measure has
been tested, validated, and endorsed as
it is currently collected, and to maintain
our current accuracy, we have proposed
to maintain those methods.
Comment: Several comments
supported the addition of the proposed
quality measure to the SNF QRP, but
urged that the measure be risk adjusted,
expressing concerns that public
reporting of falls with injury rates across
settings would be inappropriate without
taking into account differences in
resident acuity and other characteristics,
such as cognition and socioeconomic
status. One commenter stated that falls
occur for various reasons, some of them
unavoidable, and therefore, fall rates
may not be suitable for quality
comparison suggesting that it would be
improper to use the measure in pay-for
performance models. Another
commenter suggested that falls with
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46441
major injuries ‘‘are a never event’’ (that
is, events or medical errors that should
never transpire, such as falls that
happen in a health care setting that
result in patient death or serious
injury[).64 Another commenter cited
American and British Geriatrics Society
guidelines, which find no clear
evidence on falls prevention. Some
commenters pointed out that the TEP
convened in 2015 recommended risk
adjustment for cognitive impairment,
which several commenters also
supported, and one commenter asked
whether the TEP was presented the
current specifications of the crosssetting falls measure. One commenter
provided support for risk adjustment by
pointing out that the references cited in
the proposed rule indicate that risks for
falls vary by resident characteristics,
that the State Operations Manual (SOM)
for SNFs provides guidance for
evaluating residents for risk for falls,
and that documentation for not risk
adjusting the measure was not provided
in the proposed rule. The same
commenter pointed to the PAC Payment
Reform Demonstration (PAC PRD), in
which the commenter stated that the
research indicated that the risk of falls
with injury differs across post-acute
settings. Several commenters also stated
that risk adjustment is required by the
IMPACT Act, and that the MAP
suggested that the measure should be
risk adjusted.
Response: We appreciate the
commenters’ suggestions that the
proposed application of the quality
measure, the Percent of Residents
Experiencing One or More Falls with
Major Injury (Long Stay) (NQF #0674)
should be risk adjusted. The application
of risk adjustment, as stated by the
IMPACT Act, is ‘‘as determined
appropriate by the Secretary’’ under
section 1899B(c)(3)(B) of the Act.
While we acknowledge that resident
characteristics that elevate risk for falls
with major injury vary across the SNF
population, a TEP convened in 2009 by
the measurement development
contractor concluded that risk
adjustment of this quality measure
concept was inappropriate because it is
each facility’s responsibility to take
steps to reduce the rate of injurious
falls, especially since such events are
considered to be ‘‘never events.’’ We
note that the PAC PRD did not analyze
falls with major injury, as falls with
major injury was not an assessment item
that was tested. However, as the
commenter pointed out, the prevalence
64 National Quality Forum (NQF), Serious
Reportable Events In Healthcare—2011 Update: A
Consensus Report, Washington, DC: NQF; 2011.
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of a history of falls prior to the PAC
admission did vary across post-acute
settings (as assessed by Item B7 from the
CARE tool: ‘‘History of Falls. Has the
patient had two or more falls in the past
year or any fall with injury in the past
year? ’’). Nonetheless, we believe that as
part of best clinical practice, SNFs
should assess residents for falls risk and
take steps to prevent future falls with
major injury.
The numerator, denominator, and
exclusions definitions provided to the
TEP in 2015 are virtually identical to
the specifications we proposed to adopt
for this measure, and did not include
risk adjustment. Two out of 11 members
of the 2015 TEP supported risk
adjustment of the falls measure for
cognitive impairment, but it was not the
majority position. For more information
on the 2015 TEP, please visit https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/Downloads/SUMMARY-OFFEEDBACK-FROM-THE-TECHNICALEXPERT-PANEL-TEP-REGARDINGCROSS-SETTING-MEASURESALIGNED-WITH-THE-IMPACT-ACT-OF2014-Report.pdf.
We believe factors that increase the
risk of falling, such as cognitive
impairment, should be included by
facilities in their risk assessment to
support proper care planning. As cited
in the proposed rule, research suggests
that 78 percent of falls are anticipated
falls, occurring in individuals who
could have been identified as at-risk for
a fall using a risk-assessment scale. Risk
adjusting for falls with major injury
could unintentionally lead to
insufficient risk prevention by the
provider. As required by the Deficit
Reduction Act of 2007, the Hospital
Acquired Conditions-Present On
Admission (HAC–POA) Indicator
Reporting provision requires a quality
adjustment in the Medicare SeverityDiagnosis Related Groups (MS–DRG)
payments for certain HACs, which
include falls and trauma, and these
payment reductions are not risk
adjusted. Furthermore, we note that the
State Operations Manual (SOM)
provides guidance for SNFs to assess
resident risk for falls with the intent to
aid providers in prevention of falls. The
need for risk assessment, based on
varying risk factors among residents,
does not remove the obligation of
providers to minimize that risk.
With regard to the MAP
recommendation to risk adjust this
measure cited by the commenter, the
MAP feedback regarding risk adjustment
for this quality measure applied to the
home health setting, not to the SNF
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setting. We also refer readers to a more
recent Cochrane review of 60
randomized controlled trials, which
found that within care facilities,
multifactorial interventions have the
potential to reduce rates of falls and risk
of falls.65
Comment: One commenter requested
that CMS consider risk adjusting the
proposed application of the quality
measure, the Percent of Residents
Experiencing One or More Falls with
Major Injury (Long Stay) (NQF #0674)
for sociodemographic status, to better
reflect the realities that affect the care of
special populations and the need for
coordination with hospitals within a
geographic region. The commenter
suggested that some beneficiaries in
certain populations are more complex
and therefore, their risk for falls
resulting in major injuries may increase.
Response: While we appreciate these
comments and the importance of the
role that sociodemographic status plays
in the care of patients, we continue to
have concerns about holding providers
to different standards for the outcomes
of their patients of low
sociodemographic status because we do
not want to mask potential disparities or
minimize incentives to improve the
outcomes of disadvantaged populations.
We routinely monitor the impact of
sociodemographic status on facilities’
results on our measures.
NQF is currently undertaking a twoyear trial period in which new measures
and measures undergoing maintenance
review will be assessed to determine if
risk-adjusting for sociodemographic
factors is appropriate for each measure.
For two-years, NQF will conduct a trial
of a temporary policy change that will
allow inclusion of sociodemographic
factors in the risk-adjustment approach
for some performance measures. At the
conclusion of the trial, NQF will
determine whether to make this policy
change permanent. Measure developers
must submit information such as
analyses and interpretations as well as
performance scores with and without
sociodemographic factors in the risk
adjustment model.
Furthermore, the ASPE is conducting
research to examine the impact of
socioeconomic status on quality
measures, resource use, and other
measures under the Medicare program
as directed by the IMPACT Act. We will
closely examine the findings of these
65 Cameron ID, Gillespie LD, Robertson MC,
Murray GR, Hill KD, Cumming RG, Kerse N.
Interventions for preventing falls in older people in
care facilities and hospitals. Cochrane Database of
Systematic Reviews 2012, Issue 12. Art. No.:
CD005465. DOI: 10.1002/
14651858.CD005465.pub3.
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reports and related Secretarial
recommendations and consider how
they apply to our quality programs at
such time as they are available.
Comment: One commenter believed
that collecting data on falls would be
burdensome for residents who are on
the unit for only part of a day. Another
commenter recommended shortening
the discharge assessment to only
include necessary information to
decrease the data collection burden.
Response: We appreciate the
commenter’s position that tracking falls
for residents who are on the unit for
only part of a day could be burdensome.
However, given that facilities are
responsible for residents’ safety
regardless of location within the facility
or duration of time spent in various
units, if a resident experiences an
injurious fall, no matter their location in
the facility, that fall will need to be
tracked and reported. Moreover, data on
falls are already collected in the MDS,
so the additional burden associated with
this measure is minimal. We note that
the SNF PPS Part A Discharge
assessment is limited to just the items
necessary to calculate the three SNF
QRP measures proposed in this rule to
minimize any additional burden.
Comment: Several commenters
supported the measure’s addition to the
SNF QRP, but expressed concerns about
the measure not having been adequately
tested in the short-stay or SNF
population. Additionally, several
commenters expressed concerns
regarding the lack of NQF endorsement
for an application of the quality
measure, the Percent of Residents
Experiencing One or More Falls with
Major Injury (Long Stay) (NQF #0674) as
a cross-setting measure for SNF, IRF and
LTCH QRPs. Other commenters
mentioned that the MAP conditionally
supported this measure pending NQF
endorsement.
Response: We thank the commenters
for their support of the measure and
suggested changes to the measure. We
also appreciate the commenters’
concerns pertaining the adequacy of the
measure’s testing for use in the shortstay or SNF population, which we
interpret to mean adequacy regarding
the reliability and validity of the
proposed application of the quality
measure, the Percent of Residents
Experiencing One or More Falls with
Major Injury (Long Stay) (NQF #0674)
and the items used to calculate the
measure in the SNF setting.
This proposed measure is a crosssetting measure that we believe satisfies
the measure required under section
1899B(c)(1)(D) of the Act domain,
Incidence of Major Falls. For the reasons
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provided previously, we proposed this
measure under the exception authority
provided in section 1899B(e)(2)(B) of
the Act, which allows CMS to apply a
measure to the SNF setting that is not
NQF-endorsed as long as due
consideration is given to measures that
have been endorsed or adopted by a
consensus organization.
With regard to the adequacy of the
measure’s testing for use in the shortstay or SNF population, the item-level
testing during the development of the
MDS 3.0 showed near-perfect inter-rater
reliability for the MDS item (J1900C)
used to identify falls with major injury;
therefore, we disagree with the
commenter’s suggestion as to the
strength of the item-level testing.66 The
NQF measure evaluation criteria do not
require measure level reliability if item
reliability is high.67 However, we
believe that, given the overlap in the
populations and item-level testing
results, the application of this measure
for SNF residents will be reliable. That
said, we intend to continue to test the
measure once data collection begins as
part of ongoing maintenance of the
measure. We also note that a TEP
convened in 2009 supported measuring
falls with major injury in PAC settings
regardless of the length of stay of the
resident. The TEP also concurred that
facilities need to take responsibility to
not only prevent falls but to ensure that
if they do occur, protections are in place
so that the fall does not result in injury.
Comment: One commenter urged
CMS to provide clarification in the final
rule about the use of current falls MDS
3.0 data items under the SNF QRP.
Others requested clarification on the
measure specifications, stating that the
specifications for how this measure will
be constructed using admission and
discharge assessments are unclear. Two
commenters requested clarification
about whether the numerator includes
falls with and without injury. Another
commenter asked if OBRA assessments
are considered in the look-back scan
and whether both long-stay and shortstay residents are included in the
measure. One commenter requested that
CMS clarify how the addition of the
66 Saliba D. and Buchanan J. (2008). Development
and Validation of a Revised Nursing Home
Assessment Tool: MDS 3.0. Contract No. 500–00–
0027/Task Order #2. Santa Monica, CA: Rand
Corporation. Retrieved from https://
www.cms.hhs.gov/NursingHomeQualityInits/
Downloads/MDS30FinalReport.pdf; https://
www.geronet.med.ucla.edu/centers/borun/
Appendix_A-G.pdf.
67 NQF. Measure Evaluation Criteria and
Guidance for Evaluating Measures for Endorsement.
April 2015. Available online at: https://
www.qualityforum.org/WorkArea/
linkit.aspx?LinkIdentifier=id&ItemID=79434.
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MDS discharge assessment will affect
the measure specifications for the
numerator and denominator of the falls
measure. The commenter noted that
CMS proposes modifying the MDS
discharge assessment to collect
information for Part A FFS Medicare
beneficiaries who continue in the SNF
after ending their SNF Part A covered
stay, but does not clarify how this
change will be implemented in the
proposed falls measure. That
commenter was concerned that if this
new MDS discharge assessment is not
included, the measure will exclude
individuals who are admitted but not
discharged from the SNF during their
PAC stay and limit CMS’ ability to
provide meaningful information to both
PAC providers and consumers.
Response: To clarify, the proposed
quality measure will be calculated for
the purposes of the SNF QRP on
residents receiving services under a SNF
Part A covered stay. To further clarify,
although this measure is based on the
data collection of two items, the
numerator and denominator only use
one item: the number of falls with major
injury. The assessment instrument
includes an item about whether any fall
took place (J1800) as a gateway item. If
there were any falls, the assessor then
completes the next set of items (J1900)
indicating the number of falls by injury
status. Facilities must report the data
associated with all these items in order
to avoid issues with missing data and as
a way to ensure accurate data collection,
but only the data on falls with major
injury are used in calculating the
measure.
We also want to clarify that the items
used to calculate the measure are
already included on the existing MDS
3.0 item sets, for example, both OBRA
and PPS assessments. The necessary
falls items will also be added to the
proposed SNF PPS Part A Discharge
assessment to ensure the capture of falls
with major injury at the end of the SNF
Part A covered stay for residents who
continue in the SNF after ending their
SNF Part A covered stay.
Other than the proposed SNF PPS
Part A Discharge assessment, the
implementation of the proposed
application of the quality measure, the
Percent of Residents Experiencing One
or More Falls with Major Injury (Long
Stay) (NQF #0674) does not represent
new data collection for SNFs. SNFs
have been submitting data for these
items as part of the Nursing Home
Quality Initiative since October 2010.
We note that specifications for the
application of the quality measure, the
Percent of Residents Experiencing One
or More Falls with Major Injury (Long
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Stay) (NQF #0674) for the SNF
population are available on our SNF
QRP measures and technical Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting-ProgramMeasures-and-TechnicalInformation.html. The specifications
include information on how the SNF
PPS Part A Discharge will be used in the
measure, and specify that the measure
will apply to both long- and short-stay
Medicare FFS beneficiaries as long as
they have had a SNF PPS Part A covered
stay.
Comment: Several commenters
expressed concerns about the falls
measure not being standardized across
PAC settings. One commenter stated
that the measure should have the same
wording, timeframe, and item set across
all PAC settings, and that the
denominator and exclusions should be
the same; they also specifically noted
differences in the payers that are
required to report data for this measure.
Two commenters objected to the
exclusion of Medicare Advantage
beneficiaries from the numerator and
denominator for this measure. One
commenter noted that measures based
on only Medicare FFS beneficiaries may
be incomplete, since, according to some
estimates, only about half of SNF
residents are covered by Medicare FFS.
Another commenter asked about the
extent to which the time horizon (that
is, the time period during which the
measure will be calculated) will differ
across settings, and another suggested
that the exclusions listed in the
specifications were different in different
settings. One comment mistakenly
asserted that the item used in the
equivalent IRF specifications asks about
the occurrence of two or more falls in
the past year and whether a patient had
major surgery, in contrast to the SNF
specifications for the measure. Another
commenter expressed concern regarding
differences in the populations across
quality measures in the SNF QRP. The
commenters mentioned that the falls
measure (NQF #0674) and function
measure (NQF #2631) include only
Medicare FFS residents, while the
pressure ulcer measure (NQF #0678)
includes all short-stay SNF residents.
The commenter mentioned that this
inconsistency could result in confusion
for providers because of the varying
denominators across measures.
Response: CMS appreciates the
commenters’ comments pertaining to
the differences in the quality measure
denominators by payer type across the
IRF, SNF and LTCH settings. As
previously stated, we believe that
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quality care is best represented through
the inclusion of all patient data
regardless of payer source. We agree that
consistency in the data would reduce
confusion in data interpretation and
enable a more comprehensive
evaluation of quality and although we
had not proposed all payer data
collection through this current
rulemaking, we will take into
consideration the expansion of the SNF
QRP to include all payer sources
through future rulemaking.
We appreciate the comment
pertaining to consistent data collection
across the reporting programs. We
believe that quality measures that
include all residents in a facility are
better able to capture the health
outcomes of that facility’s residents, and
thus, including all residents in quality
reporting is important. Regarding
expansion of the population used to
calculate this measure to include payer
sources beyond Medicare Part A, we
agree with the commenter’s position
and intend to take this under
consideration through future measure
development and rulemaking.
We wish to clarify that this falls
measure is not currently used for the
short-stay nursing home population as
part of Nursing Home Compare and that
this measure will be calculated using
only Medicare Part A data collected by
the SNF.
With regard to the use of standardized
items for this measure, until now, the
post-acute assessment instruments have
not included standardized items for falls
with major injury. Although the quality
measure, an Application of Percent of
Residents Experiencing One or More
Falls with Major Injury (Long Stay)
(NQF #0674), and the data collection
items used to calculate this measure are
harmonized across settings and
assessment instruments, we believe that
there are constraints in current data
collection (that is, use of only admission
and discharge assessments in IRFs and
LTCHs vs. admission/re-entry, interim,
and discharge assessments in SNFs.).
For the purposes of measure calculation,
we are able to compensate for this data
collection approach to ensure a uniform
application of the measure where
currently practicable for providers and
feasible for the measure so that we have
harmonized the measure’s calculation
across all PAC settings. Although we
believe that we have applied the
measure consistently across the
programs, to enable efficiencies in the
measure’s calculation, we intend to
address any outstanding standardization
issues through future rulemaking.
We would like to clarify that the
occurrence of two or more falls in the
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past year and major surgery prior to
admission are risk-adjusters for the
function outcomes measures proposed
in the FY 2016 IRF PPS proposed rule
and are not related to the cross-setting
falls measure, and therefore, are not
included in SNF QRP version of the
falls measure. We also wish to clarify
that as proposed, the application of this
measure for the SNF QRP will include
a look-back from the time of discharge
from the SNF Part A covered stay to the
time of admission, so that the measure’s
calculation and time frame used will be
consistent with the other QRPs. We note
that the assessment at discharge is an
actual discharge from the facility or a
discharge from the SNF Part A covered
stay with a transition in place. We also
disagree that the exclusions listed in the
measure specification for each setting
are not standardized. Specifically, all
three settings only exclude cases due to
missing data.
Comment: One commenter supported
this measure, but expressed concerns
about the accuracy of the data on which
the fall measure is calculated, noting
that a recent survey identified
deficiencies in reporting by a small
sample of SNFs. One commenter
expressed concerns regarding the fact
that CMS excludes residents for whom
missing data precludes calculation of
the measure from the measure
calculations. The commenter expressed
concerns that this exclusion may
encourage gaming, because if a facility
recognizes that a resident is declining,
it can simply omit some data for that
resident, ensuring that the resident is
excluded from the measure calculation.
The commenter referenced several
different media reports, which highlight
the seriousness of gaming of MDS 3.0
data.
Response: We have proposed and are
finalizing a threshold for reporting of
actual resident data for determinations.
We also intend to carefully monitor
rates of missing data across all facilities.
Specifically, we have proposed and are
now finalizing that for FY 2018 SNF
QRP, any SNF that does not meet the
requirement that 80 percent of all MDS
assessments submitted contain 100
percent of all data items necessary to
calculate the SNF QRP measures would
be subject to a reduction of 2 percentage
points to its FY 2018 market basket
percentage. We hope this requirement
will provide incentives to providers to
submit complete MDS 3.0 assessments.
Further, we intend to align with other
QRPs and propose through future
rulemaking to implement a data
validation program. Historically, rates of
missing data for the items used to
calculated for the NHQI falls measure in
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nursing homes have averaged less than
0.01 percent across all target
assessments in a given quarter (for
example, the rate of missing data in Q3
2014 was 0.004 percent), suggesting that
missing data is minimal. Further, we
intend to align with other QRPs and
propose through future rulemaking a
process and program surrounding data
validation.
Comment: One commenter expressed
concerns about providers being
penalized for resident-centered care
practices, such as allowing frail
residents to ambulate without help.
Response: We fully support residentcentered care and enabling all residents
to make informed decisions about their
care. However, providers are
responsible for resident safety, and falls
with major injury are considered ‘‘never
events.’’ Thus, providers must balance
the desire to allow residents full
autonomy with the need to care for their
well-being, including appropriate care
planning and taking steps to reduce
injurious falls.
Having carefully considered the
comments we received on the
application of the Percent of Residents
Experiencing One or More Falls with
Major Injury (Long Stay) (NQF #0674)
measure, we are finalizing the adoption
of this measure for use in the SNF QRP.
(3) Quality Measure Addressing the
Domain of Functional Status, Cognitive
Function, and Changes in Function and
Cognitive Function: 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; Endorsed on July 23, 2015)
We proposed to adopt, beginning with
the FY 2018 SNF QRP, an application of
the quality measure Percent of LongTerm Care Hospital Patients with an
Admission and Discharge Functional
Assessment and a Care Plan that
Addresses Function (NQF #2631;
endorsed on July 23, 2015) as a crosssetting quality measure that satisfies the
functional status, cognitive function,
and changes in functional status and
cognitive function domain. This quality
measure reports the percent of patients
or residents with both an admission and
a discharge functional assessment and
an activity (self-care or mobility) goal
that addresses function. The new selfcare and mobility items are included in
a new section of the MDS titled, Section
GG.
The National Committee on Vital and
Health Statistics’ Subcommittee on
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Health,68 noted that ‘‘[i]nformation on
functional status is becoming
increasingly essential for fostering
healthy people and a healthy
population. Achieving optimal health
and well-being for Americans requires
an understanding across the life span of
the effects of people’s health conditions
on their ability to do basic activities and
participate in life situations in other
words, their functional status.’’ This is
supported by research showing that
patient and resident functioning is
associated with important outcomes
such as discharge destination and length
of stay in inpatient settings,69 as well as
the risk of nursing home placement and
hospitalization of older adults living in
the community.70
The majority of individuals who
receive PAC services, including care
provided by SNFs, HHAs, IRFs, and
LTCHs, have functional limitations and
many of these individuals are at risk for
further decline in function due to
limited mobility and ambulation.71 The
patient and resident populations treated
by SNFs, HHAs, IRFs, and LTCHs vary
in terms of their functional abilities at
the time of the PAC admission and their
goals of care. For IRF patients and many
SNF residents, treatment goals may
include fostering the person’s ability to
manage his or her daily activities so that
he or she can complete self-care and/or
mobility activities as independently as
possible, and if feasible, return to a safe,
active, and productive life in a
community-based setting. For home
health patients, achieving independence
within the home environment and
promoting community mobility may be
the goal of care. For other home care
patients, the goal of care may be to slow
the rate of functional decline in order to
allow the person to remain at home and
avoid institutionalization.72 Lastly, in
addition to having complex medical
care needs for an extended period of
time, LTCH patients often have
68 Subcommittee on Health National Committee
on Vital and Health Statistics, ‘‘Classifying and
Reporting Functional Status’’ (2001).
69 Reistetter TA, Graham JE, Granger CV, Deutsch
A, Ottenbacher KJ. Utility of Functional Status for
Classifying Community Versus Institutional
Discharges after Inpatient Rehabilitation for Stroke.
Archives of Physical Medicine and Rehabilitation,
2010; 91:345–350.
70 Miller EA, Weissert WG. Predicting Elderly
People’s Risk for Nursing Home Placement,
Hospitalization, Functional Impairment, and
Mortality: A Synthesis. Medical Care Research and
Review, 57; 3: 259–297.
71 Kortebein P, Ferrando A, Lombebeida J, Wolfe
R, Evans WJ. Effect of 10 days of bed rest on skeletal
muscle in health adults. JAMA; 297(16):1772–4.
72 Ellenbecker CH, Samia L, Cushman MJ, Alster
K. Patient safety and quality in home health care.
Patient Safety and Quality: An Evidence-Based
Handbook for Nurses. Vol 1.
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limitations in functioning because of the
nature of their conditions, as well as
deconditioning due to prolonged bed
rest and treatment requirements (for
example, ventilator use). The clinical
practice guideline Assessment of
Physical Function 73 recommends that
clinicians document functional status at
baseline and over time to validate
capacity, decline, or progress. Therefore,
assessment of functional status at
admission and discharge and
establishing a functional goal for
discharge as part of the care plan is an
important aspect of patient or resident
care in all of these PAC settings.
Given the variation in patient or
resident populations across the PAC
settings, the functional activities that are
typically assessed by clinicians for each
type of PAC provider may vary. For
example, rolling left and right in bed is
an example of a functional activity that
may be most relevant for lowfunctioning patients or residents who
are chronically critically ill. However,
certain functional activities such as
eating, oral hygiene, lying to sitting on
the side of the bed, toilet transfers, and
walking or wheelchair mobility are
important activities for patients or
residents in each PAC setting.
Although, functional assessment data
are currently collected by all four PAC
providers and in NFs, this data
collection has employed different
assessment instruments, scales, and
item definitions. The data cover similar
topics, but are not standardized across
PAC settings. The different sets of
functional assessment items coupled
with different rating scales makes
communication about patient and
resident functioning challenging when
patients and residents transition from
one type of setting to another. Collection
of standardized functional assessment
data across SNFs, HHAs, IRFs, and
LTCHs using common data items would
establish a common language for patient
and resident functioning, which may
facilitate communication and care
coordination as patients and residents
transition from one type of provider to
another. The collection of standardized
functional status data may also help
improve patient and resident
functioning during an episode of care by
ensuring that basic daily activities are
assessed for all PAC residents at the
start and end of care and that at least
one functional goal is established.
The functional assessment items
included in the proposed functional
73 Kresevic DM. Assessment of physical function.
In: Boltz M, Capezuti E, Fulmer T, Zwicker D,
editor(s). Evidence-based geriatric nursing protocols
for best practice. 4th ed. New York (NY): Springer
Publishing Company; 2012. p. 89–103.
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status quality measure were originally
developed and tested as part of the PostAcute Care Payment Reform
Demonstration version of the Continuity
Assessment Record and Evaluation
(CARE) Item Set, which was designed to
standardize the assessment of a person’s
status, including functional status,
across acute and post-acute settings
(SNFs, HHAs, IRFs, and LTCHs). The
functional status items on the CARE
Item Set are daily activities that
clinicians typically assess at the time of
admission and/or discharge in order to
determine patient’s or resident’s needs,
evaluate patient or resident progress,
and prepare patients, residents, and
their families for a transition to home or
to another setting.
The development of the CARE Item
Set and a description and rationale for
each item is described in a report
entitled ‘‘The Development and Testing
of the Continuity Assessment Record
and Evaluation (CARE) Item Set: Final
Report on the Development of the CARE
Item Set: Volume 1 of 3.’’ 74 Reliability
and validity testing were conducted as
part of CMS’s Post-Acute Care Payment
Reform Demonstration, and we
concluded that the functional status
items have acceptable reliability and
validity. A description of the testing
methodology and results are available in
several reports, including the report
entitled ‘‘The Development and Testing
of the Continuity Assessment Record
And Evaluation (CARE) Item Set: Final
Report On Reliability Testing: Volume 2
of 3’’ 75 and the report entitled ‘‘The
Development and Testing of The
Continuity Assessment Record And
Evaluation (CARE) Item Set: Final
Report on Care Item Set and Current
Assessment Comparisons: Volume 3 of
3.’’ 76 These reports are available on our
Post-Acute Care Quality Initiatives Web
page at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/CARE-Item-Set-and-BCARE.html.
The functional status quality measure
we proposed to adopt beginning with
the FY 2018 SNF QRP is a process
quality measure that is an application of
the quality measure, Percent of LongTerm Care Hospital Patients with an
Admission and Discharge Functional
Assessment and a Care Plan that
Addresses Function (NQF #2631;
endorsed on July 23, 2015). This quality
74 Barbara Gage et al., ‘‘The Development and
Testing of the Continuity Assessment Record and
Evaluation (CARE) Item Set: Final Report on the
Development of the CARE Item Set’’ (RTI
International, 2012).
75 Ibid.
76 Ibid.
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measure reports the percent of patients
or residents with both an admission and
a discharge functional assessment and a
treatment goal that addresses function.
This process measure requires the
collection of admission and discharge
functional status data by clinicians
using standardized clinical assessment
items, or data elements, which assess
specific functional activities, that is,
self-care and mobility activities. The
self-care and mobility function activities
are coded using a 6-level rating scale
that indicates the resident’s level of
independence with the activity at both
admission and discharge. A higher score
indicates more independence.
For this quality measure, there must
be documentation at the time of
admission that at least one activity
(function) goal is recorded for at least
one of the standardized self-care or
mobility function items using the 6level rating scale. This indicates that an
activity goal(s) has been established.
Following an initial assessment, the
clinical best practice would be to ensure
that the resident’s care plan reflected
and included a plan to achieve such an
activity goal(s). At the time of discharge,
function is reassessed using the same 6level rating scale, enabling the ability to
evaluate success in achieving the
resident’s activity performance goals.
To the extent that a resident has an
unplanned discharge, for example, for
the purpose of being admitted to an
acute care facility, the collection of
discharge functional status data might
not be feasible. Therefore, for patients or
residents with unplanned discharges,
admission functional status data and at
least one treatment goal must be
reported, but discharge functional status
data are not required to be reported.
A TEP convened by the measure
development contractor for CMS
provided input on the technical
specifications of this quality measure,
including the feasibility of
implementing the measure across PAC
settings. The TEP was supportive of the
implementation of this measure across
PAC settings and was also supportive of
our efforts to standardize this measure
for cross-setting use. Additionally, the
MAP conditionally supported the use of
an application of the Percent of LongTerm Care Hospital Patients With an
Admission and Discharge Functional
Assessment and a Care Plan that
Addresses Function (NQF #2631;
endorsed on July 23, 2015) for use in the
SNF QRP as a cross-setting measure.
The MAP noted that this functional
status measure addresses an IMPACT
Act domain and a MAP PAC/LTC core
concept. The MAP conditionally
supported this measure pending NQF-
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endorsement and resolution of concerns
about the use of two different functional
status scales for quality reporting and
payment purposes. Finally, the MAP
reiterated its support for adding
measures addressing function, noting
the group’s special interest in this PAC/
LTC core concept. More information
about the MAP’s recommendations for
this measure is available in the report
entitled MAP Off-Cycle Deliberations
2015: Measures under Considerations to
Implement Provisions of the IMPACT
Act, is available at https://
www.qualityforum.org/Project_Pages/
MAP_Post-Acute_CareLong-Term_Care_
Workgroup.aspx.
The proposed measure is derived
from the Percent of Long-Term Care
Hospital Patients With an Admission
and Discharge Functional Assessment
and a Care Plan that Addresses Function
quality measure, and we submitted the
proposed measure to NQF for
endorsement. The specifications are
available for review at the SNF QRP
measures and technical Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting-ProgramMeasures-and-TechnicalInformation.html.
We reviewed the NQF’s endorsed
measures and were unable to identify
any NQF-endorsed cross-setting quality
measures focused on assessment of
function for PAC patients and residents.
We are also unaware of any other crosssetting quality measures for functional
assessment that have been endorsed or
adopted by another consensus
organization. Therefore, we proposed to
adopt this function measure for use in
the SNF QRP for the FY 2018 payment
determination and subsequent years
under the Secretary’s authority under
section 1899B(e)(2)(B) of the Act to
select non-NQF-endorsed measures as
long as due consideration is given to
measures that have been endorsed or
adopted by a consensus organization.
We proposed that data for the
proposed quality measure would be
collected through the MDS 3.0, which
SNFs currently submit through the QIES
ASAP system. We refer readers to
section V.C.7 of this final rule for more
information on the proposed data
collection and submission timeline for
this proposed quality measure. The
calculation algorithm of the proposed
measure is described in the FY 2016
SNF PPS proposed rule (80 FR 22075).
For purposes of assessment data
collection, we proposed to add new
functional status items to the MDS 3.0.
The items would assess specific selfcare and mobility activities, and would
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be based on functional items included
in the Post-Acute Care Payment Reform
Demonstration version of the CARE Item
Set. The items have been developed and
tested for reliability and validity in
SNFs, HHAs, IRFs, and LTCHs. More
information pertaining to item testing is
available on our Post-Acute Care
Quality Initiatives Web page at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/CARE-Item-Set-and-BCARE.html.
The proposed function items that we
will add to the MDS for purposes of the
calculation of this proposed quality
measure do not duplicate existing items
currently collected in that assessment
instrument for other purposes. The
currently used MDS function items
evaluate a resident’s most dependent
episode that occurs three or more times,
whereas the proposed functional items
would evaluate an individual’s usual
performance at the time of admission
and at the time of discharge.
Additionally, there are several key
differences between the existing and
new proposed function items that may
result in variation in the resident
assessment results including: (1) The
data collection and associated data
collection instructions; (2) the rating
scales used to score a resident’s level of
independence; and (3) the item
definitions. A description of these
differences is provided with the
measure specifications on our SNF QRP
measures and technical Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting-ProgramMeasures-and-TechnicalInformation.html.
Because of the differences between
the current function assessment items
(Section G of the MDS 3.0) and the
proposed function assessment items that
we would collect for purposes of
calculating the proposed measure, we
would require that SNFs submit data on
both sets of items. Data collection for
the new proposed function items do not
substitute for the data collection under
the current Section G.
We invited public comments on our
proposal to adopt beginning with the FY
2018 SNF QRP an application of the
quality measure Percent of Long-Term
Care Hospital Patients with an
Admission and Discharge Functional
Assessment and a care Plan that
Addresses Function (NQF #2631;
endorsed on July 23, 2015). The
following is a summary of the comments
received and our responses.
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Comment: MedPAC did not support
the adoption of the function process
measure in the SNF QRP, and urged
CMS to adopt outcomes measures
focused on changes in resident physical
and cognitive functioning while under a
provider’s care.
Response: We appreciate MedPAC’s
preference for moving toward the use of
functional outcome measures in order to
assess the resident’s physical and
cognitive functioning under a provider’s
care. We believe that the use of this
process measure at this time will give us
the data we need to develop a more
robust outcome-based quality measure
on this topic in the future. The proposed
function quality measure, an
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;
endorsed on July 23, 2015), has
attributes to enable outcomes-based
evaluation by the provider. Such
attributes include the assessment of
functional status at two points in time,
admission and discharge, enabling the
provider to identify, in real time,
changes, improvement or decline, as
well as maintenance. Additionally, the
proposed quality measure requires that
the provider indicate at least one
functional goal associated with a
functional activity, and the provider can
calculate the percent of patients who
meet goals. Such real time use enables
providers to engage in person-centered
goal setting and the ability to use the
data for quality improvement efforts. In
particular, we are currently developing
functional outcome measures, including
self-care and mobility quality measures,
for use in the SNF setting. These
outcome function quality measures are
intentionally being designed to use the
same standardized functional
assessment items that are included in
the proposed function process measure,
which will result in a limited additional
reporting burden for SNFs.
Comment: One commenter supported
the concept of measuring function and
monitoring the percentage of residents
with completed functional assessments.
The commenter was pleased that the
quality measure, an 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, endorsed on July 23, 2015),
was proposed for multiple PAC settings
in accordance with the IMPACT Act.
The commenter, as well as several other
commenters, noted that the proposed
quality measure is an application of the
LTCH quality measure, and that fewer
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functional assessment items are in the
proposed measure when compared to
the LTCH process quality measure, the
Percent of Long-Term Care Hospital
Patients with an Admission and
Discharge Functional Assessment and a
Care Plan That Addresses Function
(NQF #2631, endorsed on July 23, 2015.
For example, one commenter noted that
the Confusion Assessment Method
(CAM©) items and the Bladder
Continence items are not included in
the proposed application of the quality
measure.
Response: The proposed functional
status process quality measure is
specified as a cross setting quality
measure and is standardized across
multiple settings. However, to clarify
which specific function items are
included in each function measure for
each QRP, we added a table to the
document entitled, SNF QRP:
Specifications of Quality Measures
Adopted in the FY 2016 Final Rule,
which identifies which functional
assessment items are used in the crosssetting process measure as well as the
setting-specific IRF and LTCH outcome
quality measures. The document is
available athttps://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
NursingHomeQualityInits/SNF-QualityReporting-Program-Measures-andTechnical-Information.html.
We believe that standardization of
assessment items across the spectrum of
post-acute care is an important goal. In
this cross-setting process quality
measure, there is a common core subset
of function items that will allow
tracking of residents’ functional status
across settings. We recognize that there
are some differences in residents’
clinical characteristics, including
medical acuity, across the LTCH, SNF
and IRF settings, and that certain
functional items may be more relevant
for certain patients/residents. Decisions
regarding item selection for each quality
measure were based on our review of
the literature, input from a TEP
convened by our measure contractor,
our experiences and review of data in
each setting from the PAC PRD, and
public comments.
Comment: Several commenters
questioned why CARE function items
on the proposed IRF–PAI, MDS 3.0 and
LTCH CARE Data Set are not the same
set of items and believed the measure,
an Application of The Percent of LongTerm Care Hospital Patients With an
Admission and Discharge Functional
Assessment and a Care Plan That
Addresses Function (NQF #2631;
endorsed on July 23, 2015), meant that
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the items should be the same set of
items.
Response: A core set of mobility and
self-care items are proposed for IRFs,
SNFs, and LTCHs, and are nested in the
proposed section GG of the IRF–PAI,
MDS 3.0 and LTCH CARE Data Set.
Additional function items are included
on the IRF–PAI and LTCH CARE Data
Set due to the adoption of additional
outcome-based quality measures in
those specific settings. Therefore, a core
set of items in the proposed section GG
are standardized to one another by item
and through the use of the standardized
6-level rating scale. We will work to
harmonize the assessment instructions
that better guide the coding of the
assessment(s) as we believe that this
will lead to accurate and reliable data,
allowing us to compare the data within
each setting.
Comment: Several commenters noted
that the proposed function measure is a
process measure and does not capture
functional outcomes. One commenter
did not believe that the measure would
provide incentives to improve quality of
care given that CMS will not determine
if goals are achieved. The commenters
expressed their preference for outcome
measures. One commenter preferred an
outcome measure, because they noted
concerns about residents at risk for
decline in function. Two commenters
noted that functional outcome measures
were under review at NQF, and two of
these quality measures were developed
for the SNF setting. Some of these
commenters added that function
outcome measures were proposed for
IRFs, but no functional outcomes
measures were proposed for LTCHs or
SNFs. One commenter believed that
CMS had a ‘‘few’’ years to implement
the SNF QRP and, thus, has time to
develop outcome measures. One
commenter also noted that the name of
the measure, which refers to Long-Term
Care Hospital patients, is misleading.
Several commenters expressed concern
that the proposed function process
measure does not meet the requirements
of the IMPACT Act because measures
must be outcome-based. One commenter
stated that the proposed measure did
not satisfy the specified IMPACT Act
domain as the measure is not able to
report on changes in function, and one
other commenter claimed that the
measure does not satisfy the reporting of
data on functional status. Finally, a
commenter stated that the measure does
not have an appropriate numerator,
denominator, or exclusions; lacks NQF
endorsement; fails to be based on a
common standardized assessment tool;
and lacks evidence that associates the
measure with improved outcomes. One
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commenter claims that because the
specifications for the proposed measure
are inconsistent with the measure
specifications posted by NQF for the
measure that is under endorsement
review, CMS failed to meet the
requirements under the IMPACT Act to
provide measure specifications to the
public, and further asserted that one is
not able to determine the specifications
that are associated with the proposed
measure, which is an application of the
NQF version of the measure.
Response: We agree that the use of
outcome measures is important and, as
discussed above, we are currently
developing functional outcome
measures for the SNF setting. We
appreciate the commenters concern
about monitoring for decline in function
and will take that into consideration as
we develop the SNF outcome measures.
With regard to the LTCH QRP, we
adopted the quality measure Long-Term
Care Hospital Functional Outcome
Measure: Change in Mobility Among
Patients Requiring Ventilator Support
(NQF #2632; endorsed on July 23, 2015)
in the FY 2015 Final Rule and data
collection for this outcome measure
begins in LTCHs on April 1, 2016.
The words ‘‘Long-Term Care Hospital
Patients’’ are included in the title of the
quality measure because it is an
application to the SNF setting of the
existing quality measure, Percent of
Long-Term Care Hospital Patients with
an Admission and Discharge Functional
Assessment and a Care Plan that
Addresses Function (NQF 2631;
endorsed on July 23, 2015), which is a
Long-Term Care Hospital quality
measure.
We believe that the proposed function
measure meets the requirements of the
IMPACT Act. The statute requires,
among other things, the submission of
data on the quality measures specified
in at least the domains identified in the
Act, but does not require a particular
type of measure (for example, outcome
or process) for each measure domain.
Further, as discussed in this section, the
measure has attributes within the
assessment and data collection that
enables outcomes-based evaluation by
the provider.
We also disagree with the comment
that we failed to provide the
specifications to the proposed measure.
The proposed function process quality
measure is an application of the
measure, the Percent of LTCH Patients
with an Admission and Discharge
Functional Assessment and a Care Plan
that Addresses Function (NQF #2631;
endorsed on July 23, 2015). The now
NQF-endorsed quality measure was
proposed and finalized in the IPPS/
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LTCH PPS final rule (FR 79 50291
through 50298) for adoption in the
LTCH QRP. An application of this
measure was proposed in the FY 2016
SNF QRP proposed rule, and similarly
it was proposed in the FY 2016 IPPS/
LTCH PPS proposed rule and the FY
2016 IRF PPS proposed rule. We
proposed the cross-setting version, an
application of the LTCH QRP quality
measure, based on guidance from
multiple TEPs convened by our measure
contractor, RTI International. The
specifications for this quality measure,
as well as all other proposed measures
for the SNF, LTCH, and IRF QRPs were
posted on the CMS Web site with the
posting of the proposed rules to enable
public comment. For the SNF QRP,
please see the specifications at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting-ProgramMeasures-and-TechnicalInformation.html. These specifications
were posted at the time we issued the
proposed rule.
As discussed in the proposed rule
under section V.C.5.c., prior to our
consideration to propose this measure’s
use in the SNF QRP, we reviewed the
NQF’s endorsed measures and were
unable to identify any NQF-endorsed,
cross-setting or standardized quality
measures focused on assessment of
function for PAC patients/residents. We
were also unaware of any other cross
setting quality measures for functional
assessment that have been endorsed or
adopted by another consensus
organization. Therefore, we proposed a
modified version of the quality measure,
the Percent of LTCH Patients with an
Admission and Discharge Functional
Assessment and a Care Plan that
Addresses Function (NQF #2631;
endorsed on July 23, 2015), with such
modifications to allow for its crosssetting application in the SNF QRP for
the FY 2018 payment determination and
subsequent years under the Secretary’s
authority to select a non-NQF-endorsed
measure. Since the cross-setting
measure is not identical to the measure
recommended for NQF-endorsement, it
is considered an application of the
measure.
Comment: One commenter suggested
that CMS conduct additional testing of
the CARE function items with specific
patient/resident subpopulations. The
commenter also suggested research
studies that compare CARE items with
other instruments across diverse PAC
populations. They suggested this data be
used to improve the CARE items or
replace them with other items to
address any potential floor or ceiling
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effects. This commenter also suggested
studies that compare models of care for
subpopulations so as to elicit best
practices related to complex conditions.
Response: We agree that adoption of
the proposed quality measure, an
application to of Percent of Long-Term
Care Hospital Patients with an
Admission and Discharge Functional
Assessment and a Care Plan that
Addresses Function (NQF 2631;
endorsed on July 23, 2015), would offer
many opportunities to examine best
practices for caring for SNF residents.
Examining the data for any floor and
ceiling effects in special populations is
also a very worthy research idea. With
regard to examining the CARE data
against other functional assessment
instrument data, as part of the PAC PRD
analyses, we compared data from the
existing items (that is, MDS, OASIS, and
the FIM® instrument) with data from the
analogous CARE items. More
specifically, we ran cross tabulations of
MDS function scores and CARE scores
for the patients/residents in the PAC
PRD to compare scores. A full
description of the analyses and the
results are provided in the report, The
Development and Testing of the
Continuity Assessment Record and
Evaluation (CARE) Item Set: Final
Report on the Development of the CARE
Item Set and Current Assessment
Comparisons Volume 3 of 3, and the
report is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/CARE-Item-Set-and-BCARE.html. Finally, we agree that
ongoing reliability and validity testing is
critical for all items used to calculate
quality measures.
Comment: One commenter
recommended revising the definition of
the item ‘‘eating’’ as it is a combination
of multiple elements of self-feeding,
swallowing ability, and diet texture
modification.
Response: The item ‘‘eating’’ is
classified as an activity, and is only
scored when a resident eats by mouth.
The ‘‘eating’’ score may reflect
assistance needed due to various
impairments such as hand/arm
weakness or coordination issues or
swallowing limitations. If a resident
does not eat by mouth and relies on an
alternative means of getting nutrition,
‘‘eating’’ is scored as ‘‘activity not
attempted.’’
Comment: One commenter noted that
proposed quality measures, such as the
proposed function quality measure,
should reflect several attributes,
including low reporting burden,
comprehensibility for beneficiaries, a
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high level of significance to patients/
residents, and data that is routinely
captured.
Response: We believe that this
proposed quality measure will have a
high level of significance to residents
and providers because it assesses
resident functional status and goals, and
that the measure will not impose a new,
significant reporting burden on SNFs
because many already assess these items
as part of their standard care practices.
Additionally, the NQF Person- and
Family-Centered Care panel, which
included several patient and patient
advocates, indicated by preliminary
vote that the measure meets the
moderate level of evidence for ‘‘Use and
Usability.’’ ‘‘Use and Usability’’ refers to
whether the measure is meaningful,
understandable, and useful for the
intended audiences for public reporting
and quality improvement. These
preliminary results and the description
of, ‘‘Use and Usability’’ are described in
the report entitled, Phase 2 Draft Report
for Voting, which is available on the
Person-and Family-Centered Project
Web site at https://
www.qualityforum.org/projects/person_
family_centered_care/. Among the
panel, two members voted that the
measure met the criteria at a high level,
12 indicated it met the moderate level
of evidence, and three indicated it was
low. With regard to the importance of
the measure to residents, and their
families, the measure reviewed by the
Person-and Family-Centered Care panel
did meet the importance criteria with
the majority of panel members finding
moderate level for evidence,
performance gap and high-priority.
These preliminary results and the
description of ‘‘Importance’’ are
described in the Report entitled, Phase
2 Draft Report for Voting, which is
available on the Person-and FamilyCentered Project Web site at https://
www.qualityforum.org/projects/person_
family_centered_care/.
Comment: Several commenters
indicated they support quality measures
focused on function, but did not support
the proposed cross-setting functional
status measure for the SNF QRP. Several
commenters noted their lack of support
was due to burden related to reporting
functional status information using two
distinct but similar standards and
scales, using different time frames. One
commenter noted that section G and
section GG have different measurement
metrics, with section GG providing a
more granular look at the components of
section G. They noted that collection of
function data using different and
conflicting items presents significant
operational challenges and would
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undermine the accuracy of data
collection. The commenters suggested
that the adoption of the measure would
also increase provider confusion
because SNFs would need to be familiar
with and apply different rules,
definitions, and metrics when
completing resident assessments.
Commenters also suggested that the
functional status measure increases the
reporting burden on SNFs but will also
lead to inaccurate coding of resident
function for both measurement and
payment. In addition, they noted
providers would be required to spend
significant time and resources providing
training and oversight to ensure that
each data set is completed accurately
and at the right time in the resident’s
stay. Commenters also suggested that
record keeping and reporting will be
complicated, as electronic medical
records will need to be updated to
accommodate dual processes for
recording similar clinical information
leading to greater cost to providers and
a decrease in the quality and accuracy
of the data collected. Several
commenters noted the significance of
adequate training stressing the
importance of appropriate coding of the
new items used to calculate the
proposed measures and one commenter
specifically asked for clarification on
which health care professional would be
responsible for performing the
assessment while another asked that the
Minimum Data Set (MDS) Resident
Assessment Instrument (RAI) Manual be
provided with the necessary coding and
assessment instructions for the
provider’s reference in a timely manner.
One commenter suggested transparency
with regard to how CMS will implement
the new quality measures and stated
that training for all providers, including
instructions for the revised MDS RAI
Manual, would be needed. The
commenter suggested open door forums
and training webinars for providers.
One commenter specifically asked for
clarification on which health care
professional would be responsible for
performing the assessment.
One commenter asked for clarification
about the rationale for the short
assessment period for section GG. In
addition, a commenter noted that the
coding of section GG, with the current
look-back, will make coding of section
G more complex and asked that a
streamlined coding construct that is less
complex be adopted. One commenter
suggested that CMS develop a crosswalk
to adapt the current items to create the
standardization. One commenter
suggested that CMS revise the MDS
items to reduce burden and confusion
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from the duplication of data, variation
in item definitions, and the variation in
the rating scales. One commenter
encouraged CMS to remove items from
the existing data sets where possible.
One commenter encouraged CMS to
keep the transition period, during which
both section G and section GG would be
collected, short, which would allow for
better cross-setting comparisons and
better quality measures, and which is
more in line with the intent of the
IMPACT Act. Another commenter
cautioned CMS about removing MDS
items that are used for payment,
particularly as section G has become a
‘‘payment tool for Medicaid.’’ Finally, a
commenter suggested that CMS reach
out to vendors to assure validity,
timeliness, and accuracy when MDS
changes occur.
Response: We appreciate the
commenter’s concerns related to the
new requirements that SNFs will have
to satisfy to report the proposed
function measure. We agree with the
importance of thorough and
comprehensive training and we intend
to provide such training in the near
future for all updates to the MDS and
assessment requirements. We also
recognize that SNFs might need to
conduct training to ensure that their
staffs understand how to properly fill
out both section G and section GG. We
also intend to provide comprehensive
training as we do each time the
assessment items change.
In addition to the manual and training
sessions, we will provide training
materials through the CMS webinars,
open door forums, and help desk
support. We welcome ongoing input
from stakeholders on key
implementation and training
considerations, which can be submitted
via email: PACQualityInitiative@
cms.hhs.gov.
We believe that the 6-level scale and
additional items in section GG will
allow us to better distinguish change at
the highest and lowest levels of
functioning by documenting minimal
change from no change at the low end
of the scale.77 This is important for
measuring progress in some of the most
complex cases treated in PAC. The
items in section GG were developed
with input from the clinical therapy
communities to better measure the
change in function, regardless of the
severity of the individual’s functional
limitations.
77 Barbara Gage et al., ‘‘The Development and
Testing of the Continuity Assessment Record and
Evaluation (CARE) Item Set: Final Report on the
Development of the CARE Item Set’’ (RTI
International, 2012).
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To reduce the potential burden
associated with collecting additional
items, we have included several
mechanisms in the section GG to reduce
the number of items that apply to any
one resident. First, in section GG, there
are gateway questions pertaining to
walking and wheelchair mobility that
allow the clinician to skip items that ask
if the resident does not walk or does not
use a wheelchair, respectively. For
example, in section GG, there is an item
that asks whether or not the resident
walks. If the resident does not walk,
three items in section GG related to
walking ability are skipped. Second,
section GG items will only be collected
at admission and discharge. The
gateway questions and skip patterns
mean that only a subset of section GG
items are needed for most residents.
However, by including all of them in the
form, the standardized versions are
available when appropriate for an
individual resident. With regard to the
assessment time frames, for the MDS
items located in section G, the
assessment time frames take into
consideration all episodes of the activity
that occur over a 24-hour period during
each day of the 7-day assessment
period, as a resident’s ADL selfperformance and the support required
may vary from day to day, shift to shift,
or within shifts. As stated in the CMS
MDS 3.0 Resident Assessment
Instrument manual, ‘‘the responsibility
of the person completing the
assessment, therefore, is to capture the
total picture of the resident’s ADL selfperformance over the 7-day period, 24
hours a day (that is, not only how the
evaluating clinician sees the resident,
but how the resident performs on other
shifts as well)’’ (CMS, 2014, ch. 3, p.
G–4). The CARE function items in the
proposed functional quality measures,
to be nested in the proposed Section
GG, have a shorter assessment time
frame (3 calendar days), which is
standardized across the PAC settings,
based on the need for data reflecting the
resident’s status at the time of
admission and discharge. For
admission, the CARE function items are
to reflect the status of the person as the
person is admitted to the SNF; in other
words, self-care and mobility limitations
present at the time of admission. We
recognize that when residents are first
admitted to a SNF, clinicians often
determine the resident’s clinical status
based on several observations and often
after a period of time in which the
resident adjusts to the new
environment. We also recognize that
several clinicians from different
disciplines are observing the resident’s
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status and this may not occur on the day
of admission. Further, we are aware that
residents who receive rehabilitation
services may have improvement in
function soon after admission to the
SNF as therapy services may be
provided on the day of admission or the
next day. If the admission assessment is
not completed early in the stay, the
admission score may reflect
improvement already achieved by the
resident due to treatment provided. In
other words, functional improvement
would not be reflected in function
scores if the admission assessment is
conducted after therapy has started and
impacted the resident’s status or before
therapy ends. Therefore, clinicians
report resident’s admission functional
assessment for the CARE items based on
3 calendar days. This assessment time
frame has been used in IRFs
successfully and balances the need for
data reflecting the resident’s status at
the time of admission and the interest
in documenting changes in function
between admission and discharge.
Finally, we thank the commenters for
their comments pertaining to electronic
medical records (EMRs). While we
applaud the use of EMRs, CMS does not
require that providers use EMRs to
populate assessment data. It should be
noted that with each assessment release,
we provide free software to our
providers that allows for the completion
and submission of any required
assessment data. The use of a vendor to
design software that extracts data from
a provider’s EMR to populate CMS
quality assessments, is a business
decision that is made solely by the
provider. We only require that
assessment data be submitted via the
QIES ASAP system in a specific
compatible format. Providers can choose
to use our free software, or the data
submission specifications we provide
that allow providers and their vendors
to develop their own software, while
ensuring compatibility with the QIES
ASAP system.
Comment: Several commenters noted
that the items included in the Section
GG of the MDS differ from those tested
during the PAC PRD and represented a
limited set of items from the original
CARE Tool. One of these commenter
suggested that the contributions of
occupational therapy may not be
measureable with the limited set of
items. Another commenter suggested
that the assessment time frame differed
from that used in the PAC PRD.
Response: The PAC PRD tested a
range of items, some of which were
duplicative, to identify the best
performing items in each domain. Select
items were removed from the item set
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where testing results and clinician
feedback suggested the need for fewer
items to be included in a particular
scale. We also received feedback on the
items tested in the PAC PRD from a
cross-setting TEP convened by our
measure development contractor, RTI
International. Other changes from the
original PAC–PRD items included
incorporating instructional detail from
the manual and training materials
directly into the data collection form
and updating skip patterns to minimize
burden. We agree that the contribution
of occupational therapy as well as other
clinical disciplines, should be reflected
in all item and measure development.
During the PAC–PRD, clinicians from
many different disciplines collected
CARE data, including occupational
therapists (OTs). In addition, the items
in section GG were developed with the
input from clinicians would be
performing the assessments, including
OTs.
With regard to the assessment time
frame for the CARE function items, we
instructed clinicians to use a 2-day time
frame if the patients/residents were
admitted before 12 p.m. (noon) or 3
calendar days if the patients/residents
were admitted after 12 p.m. Our exit
interviews revealed that most patients/
residents were admitted to the SNF after
12 p.m. and that clinicians used 3
calendar days. Therefore, we have used
the assessment time frame that most
clinicians used during the PAC–PRD.
Comment: One commenter expressed
concern about the reliability testing
results for licensed nurses in the PAC
PRD, given that licensed nurses play a
large role in documenting function.
Response: The reliability results
mentioned by this commenter were only
one of several reliability analyses
conducted to support the development
of this measure as part of the PAC PRD.
The results of licensed nurses reflect the
small sample. In addition to the interrater reliability study mentioned by
these commenters, we also examined:
(1) Inter-rater reliability of the CARE
items using videotaped case studies,
which included 550 assessments from
28 providers; and (2) internal
consistency of the function data, which
included more than 2,749 SNF
residents. Overall, these results indicate
moderate to substantial agreement on
these items. The report describing these
additional analyses and an
interpretation of the Kappa statistics
results is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/Downloads/TheDevelopment-and-Testing-of-the-
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Therefore, given the overall findings
of these reliability analyses, we believe
that the proposed function measure is
sufficiently reliable for the SNF QRP.
Comment: One commenter was
concerned that no data was provided
clearly linking improved outcomes to
this process measure.
Response: We believe that there is
evidence that this is a best practice
based on several clinical practice
guidelines. The NQF requirement for
endorsing process measures is that the
process should be evidence-based, such
as processes that are recommended in
clinical practice guidelines. As part of
the NQF process, CMS submitted
several such clinical practice
guidelines 78 79 80 to support this
measure, and referenced another crosscutting clinical practice guideline in the
proposed rule. The clinical practice
guideline Assessment of Physical
Function 81 recommends that clinicians
should document functional status at
baseline and over time to validate
capacity, decline, or progress. Therefore,
assessment of functional status at
admission and discharge and
establishing a functional goal for
discharge as part of the care plan (that
is, treatment plan) is an important
aspect of patient/resident care for all of
these PAC providers.
Comment: Several commenters
suggested that CMS develop a plan to
revise the existing MDS function items
to be more consistent with the data
collected in the other PAC settings,
noting this would lay the groundwork
for a measure that is more
‘‘standardized’’ and ‘‘interoperable’’
78 Kresevic DM. Assessment of physical function.
In: Boltz M., Capezuti E., Fulmer T., Zwicker D.,
editor(s). Evidence-based geriatric nursing protocols
for best practice. 4th ed. New York (NY): Springer
Publishing Company; 2012. p. 89–103. Retrieved
from https://www.guideline.gov/
content.aspx?id=43918.
79 Centre for Clinical Practice at NICE (UK).
(2009). Rehabilitation after critical illness (NICE
Clinical Guidelines No. 83). Retrieved from https://
www.nice.org.uk/guidance/CG83.
80 Balas M.C., Casey C.M., Happ M.B.
Comprehensive assessment and management of the
critically ill. In: Boltz M., Capezuti E., Fulmer T.,
Zwicker D., editor(s). Evidence-based geriatric
nursing protocols for best practice. 4th ed. New
York (NY): Springer Publishing Company; 2012. p.
600–27. Retrieved from https://www.guideline.gov/
content.aspx?id=43919.
81 Kresevic DM. Assessment of physical function.
In: Boltz M., Capezuti E., Fulmer T., Zwicker D.,
editor(s). Evidence-based geriatric nursing protocols
for best practice. 4th ed. New York (NY): Springer
Publishing Company; 2012. p. 89–103. Retrieved
from https://www.guideline.gov/
content.aspx?id=43918.
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across post-acute care settings. Some
commenters noted that this transition
would require considerable analysis to
ensure there are not negative
unintended consequences for SNF
reimbursement, and testing in SNF
facilities to ensure the revised
instrument collects accurate, reliable
and meaningful data.
Response: We have proposed to add a
core set of CARE function items to the
MDS for SNFs, the IRF–PAI for IRFs and
the LTCH CARE Data Set. These
standardized data will enable
interoperability across these PAC
settings. As noted above, the proposed
IRF–PAI and proposed LTCH CARE
Data Set include additional CARE
function items, because those QRPs
include additional functional outcome
measures, and these measures require
collection of more than just the core
items included in the function process
measure. The development of the entire
original set of CARE function items,
including the definitions for each
activity, were selected based on a
review of all existing items used by
LTCHs, IRFs, SNFs and HHAs, a review
of the literature, and input from
stakeholders such as clinicians and
researchers.
Comment: One commenter noted that
the proposed function measure includes
reporting of a goal as a way to document
that residents have a care plan that
addresses function, and that this
reporting of function goals was not part
of the original PAC PRD. The
commenter further noted that reporting
of only one goal was not ideal, because
many residents have goals for multiple
functional activities and the number of
standardized functional assessment
items is limited compared to the full set
of function items tested as part of the
PAC PRD. Finally, the commenter
indicated that treatment goals may be to
improve function, and therefore, are
restorative in nature, while therapy may
be necessary so to ensure the
maintenance of a PAC resident’s
function.
Response: The proposed function
measure requires a minimum of one (1)
goal per resident stay; however,
clinicians can report goals for each selfcare and mobility item included in the
proposed section GG of the MDS. We
believe that assessing resident function
goals should be part of clinical care and
builds upon the conditions of
participation (CoPs) for SNF providers.
The IMPACT Act also specifically
mentions goals of care as an important
aspect of the use of standardized
assessment data, quality measures, and
resource use to inform discharge
planning and incorporate resident
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preference. We agree that for many PAC
patients/residents, the goal of therapy is
to improve function and we also
recognize that for some residents,
delaying decline may be the goal. We
believe that individual, person-centered
goals exist in relation to individual
preferences and needs. We will provide
instructions pertaining to the reporting
of goals in a training manual and in
training sessions in order to better
clarify that goals set at admission may
be focused on improvement of function
or maintenance of function.
Comment: Several commenters were
concerned that the measure, an
Application of the Percent of Long-Term
Care Hospital Patients with an
Admission and Discharge Functional
Assessment and a Care Plan That
Addresses Function (NQF
#2631;endorsed on July 23, 2015) was
not NQF endorsed. Some of these
commenters noted that it was under
review at NQF for the LTCH setting and
not for the SNF setting.
Response: We agree that the NQF
endorsement process is an important
part of measure development. We have
proposed an application of the quality
measure, the Percent of Long-Term Care
Hospital Patients with an Admission
and Discharge Functional Assessment
and a Care Plan That Addresses
Function. This quality measure is now
NQF endorsed. We have a rigorous
process of construct testing and measure
selection, guided by the TEPs, public
comments from stakeholders, and
recommendations by the PAC/LTC
MAPs.
Comment: One commenter recognized
the burden of changing assessment
items, but noted the utilization of
standardized assessment items is
expected to improve transitions. The
commenter indicated that proposal was
an action of good intent toward the
statutory standardization of assessment.
Response: We thank the commenter
for their comment and support for the
inclusion of the standardized (that is,
CARE) functional assessment items. We
agree that standardized assessment
across PAC settings has the potential to
improve care.
Comment: One commenter noted that
one reason for standardized assessment
items ‘‘would be to establish a common
language for patient and resident
functioning, which may facilitate
communication and care coordination
as patients and residents transition from
one type of provider to another,’’ and
asked CMS to provide data on the
number or percent of patients/residents
that transition from one type of provider
to another. The commenter further
requested information about why the
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current measures fail to provide
clinicians with the information needed.
Response: Several studies have
documented patient/resident transition
patterns following discharge from the
hospital and continuing for 30, 60, or 90
days.82 83 84 While the exact proportions
discharging to each type of care vary
slightly across the years, the proportion
of acute hospital admissions being
discharged to PAC has grown from 35
percent in 2006 to 43 percent in more
recent years (MedPAC, 2014). Among
those discharged to PAC, the majority
are discharged to SNF or HHA, and a
much smaller proportion are discharged
to IRFs and LTCHs. Further examination
shows that among each of the four PAC
admissions, many individuals continue
to transition to subsequent sites of care.
Common discharge patterns from the
IRF, for example, include over 75
percent of cases continuing into HHA or
outpatient therapy services. SNF cases
are commonly discharged home with
either outpatient therapy or home health
services. One report outlining these
issues is entitled, ‘‘Examining Post
Acute Care Relationships in an
Integrated Hospital System’’ (available
at https://aspe.hhs.gov/health/reports/
09/pacihs/report.pdf). This report
includes a summary of the most
common PAC transition patterns for
Medicare FFS Beneficiaries in 2006.
Comment: One commenter
encouraged CMS to risk adjust all
outcome measures.
Response: The proposed function
quality measure, an Application of the
Percent of Long-Term Care Hospital
Patients with an Admission and
Discharge Functional Assessment and a
Care Plan that Addresses Function (NQF
#2631, endorsed on July 23, 2015), is a
process measure that focuses on the
clinical process of completion of
functional assessments and a care plan
addressing function. Although the
IMPACT Act requires that the cross82 Gage, B., Morley, M., Ingber, M., & Smith, L.
(2011). Post-Acute Care Episodes Expanded
Analytic File: RTI International. Prepared for the
Assistant Secretary for Planning and Evaluation.
Retrieved from https://aspe.hhs.gov/health/reports/
09/pacihs/report.pdf.
83 Gage, B., Morley, M., Constantine, R., Spain, P.,
Allpress, J., Garrity, M., & Ingber, M. (2008).
Examining Relationships in an Integrated Hospital
System: RTI International. Prepared for the
Assistant Secretary for Planning and Evaluation.
Retrieved from https://aspe.hhs.gov/health/reports/
08/examine/report.html.
84 Gage, B., Pilkauskas, N., Dalton, K.,
Constantine, R., Leung, M., Hoover, S., & Green, J.
(2007). Long-Term Care Hospital (LTCH) Payment
System Monitoring and Evaluation Phase II Report
RTI International. Prepared for the Centers for
Medicare & Medicaid Services. Retrieved from
https://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/LongTermCareHospitalPPS/
downloads/rti_ltchpps_final_rpt.pdf.
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setting quality measures be risk-adjusted
as determined appropriate by the
Secretary, it does not limit the Secretary
to adopting outcome measures. Some
process measures are risk adjusted,85 86
However, in the development of an
application of the measure, the Percent
of LTCH Patients with an Admission
and Discharge Functional Assessment
and a Care Plan that Addresses Function
(NQF #2631; endorsed on July 23, 2015),
the Technical Expert Panel considered,
but did not recommend, the application
of a risk adjustment model. We agree
with that conclusion because the
completion of a functional assessment,
which includes the use of ‘‘activity not
attempted’’ codes, is not affected by the
medical and functional complexity of
the resident. Therefore, we believe that
risk adjustment of this quality measure
is not warranted.
Comment: Several commenters noted
additional areas of function that are key
to residents, including cognition,
communication, and swallowing. One
commenter encouraged CMS to consider
cognition and expressive and receptive
language and swallowing as items of
function and not exclusively as risk
adjustors, and offered their expertise to
CMS for discussions and to develop
goals. Another commenter examined the
SNF, IRF, HHA and LTCH assessment
instruments and noted that cognitive
function is measured differently across
the settings in terms of content, scoring
process, and intended calibration of
each tool, and encouraged CMS to align
items and quality measurement of
cognition.
Response: We are working toward
developing quality measures that assess
areas of cognition and expression,
recognizing that these quality topic
domains are intrinsically linked or
associated to the domain of function
and cognitive function. We appreciate
the commenter’s offer for assistance and
encourage the submission of comments
and measure specification details to our
comment email: PACQualityInitiative@
cms.hhs.gov.
Comment: One commenter suggested
that CMS remove some items from
section G if section GG items are
adopted. One commenter noted that the
85 For example, in the NQF-endorsed process
measure Percent of Residents Who Have/Had a
Catheter Inserted and Left in Their Bladder (long
stay) (NQF#0686) for which we are the steward,
resident-level limited covariates (Frequent bowel
incontinence, or always incontinent on prior
assessment; and Pressure ulcers at stages II, III, or
IV on prior assessment) are used in a logistic
regression model to calculate a resident-level
expected quality measure score.
86Peter C. Smith, Elias Mossialos, Irene
Papanicolas and Sheila Leatherman. Performance
Measurement for Health.
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four late-loss activities of daily living
(ADL) items from Section G should be
retained and this commenter recognized
that some items were needed for
payment. The commenter noted
differences in the rating scales for the
items in section G and the items in
section GG.
Response: We recognize that the items
in section G serve many purposes such
as those items that are used for
payment, and will continue to take into
consideration all factors pertaining to
payment and quality.
Comment: One commenter was
concerned that residents with missing
data in their assessment records would
be excluded from this measure. This
commenter was concerned that this
could present SNFs with an opportunity
to purposefully exclude data.
Response: We thank the commenter
for their comments and appreciate the
concerns pertaining to intentionally
excluded data. We would like to clarify
that there are no resident exclusions
criteria for this measure. Therefore, this
potential for ‘‘gaming’’ does not exist for
this measure. Nonetheless, as part of our
compliance analysis we intend to
carefully monitor rates of missing data
across all facilities. Specifically, we are
finalizing that for FY 2018, any SNF that
does not meet the proposed requirement
that 80 percent of all MDS assessments
submitted contain 100 percent of all
data items necessary to calculate the
SNF QRP measures would be subject to
a reduction of two percentage points to
its FY 2018 market basket percentage.
We hope this requirement will
incentivize providers to submit
complete MDS 3.0 assessments.
Comment: A commenter was
concerned about the use of a consistent
definition of the short-stay population,
the denominator, in this function
measure, as well as the other proposed
measures for use in the SNF QRP. The
commenter was also concerned about
the alignment of measures with major
CMS initiatives.
Response: We appreciate the
commenters’ comments pertaining to
the differences in the function quality
measure denominators by payer type
across the IRF, SNF and LTCH settings
and we have addressed this comment
previously. We believe that quality care
is best represented through the
inclusion of all patient data regardless
of payer source. We agree that
consistency in the data would reduce
confusion in data interpretation and
enable a more comprehensive
evaluation of quality and although we
had not proposed all payer data
collection through this current
rulemaking, we will take into
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consideration the expansion of the SNF
QRP to include all payer sources
through future rulemaking.
Comment: Two commenters requested
that CMS continue in its public
engagement with stakeholders, and one
requested increased engagement with
regard to the IMPACT Act and measures
it considers. Other commenters stated
their appreciation for inclusion and
opportunity to work with CMS during
the implementation phases of the
IMPACT Act. One commenter also
recommended that CMS establish a
more formal stakeholder group to
include rehabilitation professionals who
can provide expertise on the provision
of rehabilitation therapy in NFs. This
commenter noted that the more
opportunities stakeholders have to
engage in dialogue with and advise CMS
on the quality measures, the greater the
possibility that the measures will be
accurate and helpful to determining care
quality.
Response: We appreciate the
continued involvement of stakeholders
in all phases of measure development
and implementation, as we see the value
in strong public-private partnerships.
We also believe that ongoing
stakeholder input is important to the
success of the IMPACT Act and look
forward to continued and regular input
from the provider communities as we
continue to implement the IMPACT Act.
Comment: One commenter suggested
that the PAC PRD data was collected
only by therapists, and expressed
concern that the items had not been
tested using other care providers. In
addition, this commenter had specific
questions about scoring different
assessments during the time window
proposed. This commenter also had
specific questions about which SNF
clinicians will complete the functional
assessment items for this measure.
Response: We wish to clarify that
during the PAC PRD, data were
collected by clinicians from many
different disciplines, including OTs,
PTs, SLPs and RNs. Reliability testing
included testing by discipline as well as
by setting. However, the items were
developed with the input of various
personnel who would be performing the
assessments, which included OTs, PTs,
SLPs, and RNs. Regarding the questions
about scoring assessments and staff that
will be trained to complete functional
assessments, we have historically
provided training for providers. As we
prepare for this type of training, we will
make sure to have this type of
information available to the public to
increase transparency and readiness.
Comment: A commenter urged CMS
to develop function measures that take
resident quality of life into account. The
commenter noted that function
measures are not ‘‘one size fits all.’’
Another commenter suggested CMS
focus on key concerns of beneficiaries
with disabilities and chronic conditions,
including, where appropriate: The
ability to live as independently as
possible, to function at the maximum
extent possible, to return to employment
where appropriate, to engage in
recreational and athletic pursuits, to
engage in community activities, and to
maintain the highest quality of life
possible.
Response: We believe that this
proposed quality measure will have a
high level of significance to residents
and providers. The proposed function
quality measure is a person and familycentered process measure that reports
standardized functional assessment data
at admission and discharge, as well as
at least one functional status discharge
goal, demonstrating person and familycentered care. The IMPACT Act
46453
specifically mentions goals of care as an
important aspect of the use of
standardized assessment data, quality
measures, and resource use to inform
discharge planning and incorporate
resident preference. However, we are
always open to stakeholder feedback on
measure development and encourage
everyone to submit comments to our
comment email: PACQualityInitiative@
cms.hhs.gov.
Comment: One commenter
recommended that CMS exclude section
GG data from all medical review
organizations or processes for the first
three years.
Response: The item sets included in
section GG are being proposed to satisfy
measure domains under the IMPACT
Act and are not being proposed for use
in making payment determinations. The
primary purpose of medical review is to
validate medical necessity and to
identify coding discrepancies to
determine whether payment is
appropriate. The item sets in Section GG
are not being used for this purpose and
are therefore not subject to medical
review. A provider’s failure to submit
the data to complete section GG could
result in a determination of
noncompliance with the SNF QRP,
resulting in a 2 percent reduction to the
SNF’s market basked percentage for the
applicable fiscal year.
Final Decision: Having carefully
considered the comments we received
on the application of the Percent of
LTCH Patients with an Admission and
Discharge Functional Assessment and a
Care Plan that Addresses Function (NQF
#2631; endorsed on July 23, 2015), we
are finalizing the adoption of this
measure for use in the SNF QRP.
f. SNF QRP Quality Measures Under
Consideration for Future Years
TABLE 10—SNF QRP QUALITY MEASURES AND CONCEPTS UNDER CONSIDERATION FOR FUTURE YEARS
IMPACT Act Domain .......................
Measures ........................................
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IMPACT Act Domain .......................
Measure ..........................................
IMPACT Act Domain .......................
Measure ..........................................
Measures to reflect all-condition risk-adjusted potentially preventable hospital readmission rates.
(NQF #2510): Skilled Nursing Facility 30-Day All-Cause Readmission Measure (SNFRM).
(NQF #2512; NQF #2502): Application of the LTCH/IRF All-Cause Unplanned Readmission Measure for 30
Days Post Discharge from LTCHs/IRFs.
Resource Use, including total estimated Medicare spending per beneficiary.
(NQF #2158): Application of the Payment Standardized Medicare Spending Per Beneficiary (MSPB).
Discharge to community.
Percentage residents/patients at discharge assessment, who are discharged to a higher level of care or to
the community. Measure assesses if the patient/resident went to the community and whether they
stayed there. Ideally, this measure would be paired with the 30-day all-cause readmission measure.
We invited comments on the measure
domains and associated measures and
measure concepts listed in Table 10. In
addition, consistent with the
requirements of the IMPACT Act to
develop quality measures and
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standardize data for comparative
purposes, we believe that evaluating
outcomes across the post-acute care
settings using standardized data is an
important priority. Therefore, in
addition to adopting a process-based
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measure for the IMPACT Act domain of
‘‘Functional status, cognitive function,
and changes in function and cognitive
function’’, which is included in this
year’s final rule, we also intend to
develop outcomes-based quality
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measures, including functional status
and other quality outcome measures to
further satisfy this domain. These
measures will be proposed in future
rulemaking in order to assess functional
change for each care setting as well as
across care settings. The comments we
received on this topic, with their
responses, appear below.
Comment: Several commenters urged
CMS to consider future quality
measures for the SNF QRP related to
various topics including: Patient and
family engagement; nutrition; key
concerns related to a patient’s quality of
life following discharge from post-acute
care; and workforce. One commenter
requested that quality measures
currently reported through Nursing
Home Compare also be considered for
future use in the SNF QRP.
Response: We agree that the suggested
measure areas are important for quality
of care in SNFs, and we would like to
highlight that measures pertaining to
nutrition, quality of life, patient and
family engagement and person-centered
care are known gaps in quality, and
therefore, are among our priorities to
address. Such measures align with our
CMS Quality Strategy. We also agree
with the importance of workforce
related measures as we understand that
quality outcomes are often directly
linked with staffing and workforce. We
agree that measures currently reported
through Nursing Home Compare should
also be considered for future use in the
SNF QRP, and we are finalizing two
measures currently reported through
Nursing Home Compare (Percent of
Residents or Patients with Pressure
Ulcers that are New or Worsened (Short
Stay) (NQF #0678) and an application of
the measure Percent of Residents
Experiencing One or More Falls with
Major Injury (Long Stay) (NQF #0674))
for the FY 2018 SNF QRP. We will
consider the commenters’
recommendations in our measure
development and testing efforts, as well
as in our ongoing efforts to identify and
propose appropriate measures for the
SNF QRP in the future.
Comment: One commenter supported
the IMPACT Act requirement to
measure and report on rehospitalization
and discharge to community measures.
However, the commenter expressed
several concerns regarding the potential
future measures identified by CMS and
recommended several considerations for
future measure development. The
commenter did not believe that three
potential future rehospitalization
measures (Skilled Nursing Facility 30Day All-Cause Readmission Measure
(NQF #2510), Application of the LTCH/
IRF All-Cause Unplanned Readmission
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Measure for 30 Days Post Discharge
from LTCHs/IRFs (NQF #2512; NQF
#2502)) comply with IMPACT Act
requirements because the measures have
different numerator and denominator
definitions and exclusions. The
commenter is also concerned that while
the three measures are NQF-endorsed in
each of their respective settings, they are
not yet endorsed as cross-setting
measures. Finally, the commenter states
that these measures should not be
restricted to Medicare FFS beneficiaries
as this is inconsistent with the IMPACT
Act. To comply with the IMPACT Act
requirements, this commenter
recommended that CMS develop an allcause all payer rehospitalization
measure that (a) is not restricted to
Medicare FFS beneficiaries, and (b) has
the same numerator and denominator
definitions, but may use different risk
adjustment variables, in each PAC
setting. The commenter further suggests
that pairing the proposed
rehospitalization measure with the
discharge to community measure would
not be appropriate.
When developing the Discharge to
Community measure, the commenter
recommends that CMS consider
differences across PAC providers, and
the implications of those differences on
measure specification. An additional
commenter also supported the
Discharge to Community measure,
which is under consideration for future
years.
The commenter also recommended
that when developing a resource
measure, CMS should collect
information from NQF on prior work
done to address challenges related to
developing a reliable and valid resource
measure that measures total Medicare
spending per beneficiary. Finally, the
commenter stated that CMS needs to
begin working on a medication
reconciliation measure as listed in the
IMPACT Act.
Response: We believe that we have
the discretion to implement either a
within stay readmission measure, or a
post-PAC discharge readmission
measure in satisfaction of the IMPACT
Act. Therefore, both measure concepts
listed could be applicable. We
appreciate the suggestion that such a
measure not be paired with the
discharge to community measure and
will take this under consideration. With
regard to the suggested development of
an all-cause all payer rehospitalization
measure that is not restricted to
Medicare FFS beneficiaries, has uniform
numerators and denominators and is
appropriately risk adjusted in each PAC
setting, we appreciate the commenter’s
suggestions and generally agree to the
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importance of all payer data. That said,
consistent with the other PAC settings’
post-discharge hospital readmission
measures, such a cross-setting measure
for this setting is currently under
development as a claims based measure
thereby limiting its denominator to
Medicare claims data and we intend to
standardize denominator and numerator
definitions. With regard to NQF
endorsement as a cross-setting measure,
as mentioned previously, when possible
we will propose and adopt a measure
that has been endorsed by the NQF.
However, when this is not feasible, the
IMPACT Act in section 1899B(e)(2)(B),
permits the Secretary to adopt a
measure for the QRPs that is not NQFendorsed. We want to clarify that the
IMPACT Act does allow for programrelated risk adjustment, as appropriate,
and we intend to risk adjust the
readmission measure intended to satisfy
the IMPACT Act domain, which is an
all-condition risk-adjusted potentially
preventable hospital readmission rate.
We appreciate the commenter’s concern
that CMS ensure the development of a
medication reconciliation measure and
although the Medication Reconciliation
domain of the IMPACT Act was not
addressed in this year’s SNF proposed
rule, we are currently in the process of
developing a cross-setting measure to
address this domain of care.
Comment: One commenter made
several suggestions regarding the
process CMS should use when
developing future measures. The
commenter recommended that CMS
seek additional stakeholder input as it
develops more detailed specifications
for the measures under consideration for
future years and that CMS seek NQF
endorsement for future measures prior
to including them in rulemaking.
Response: We will take the
recommendations into consideration in
our measure development and testing
efforts, as well as in our ongoing efforts
to identify and propose appropriate
measures for the SNF QRP in the future.
We recognize the need for transparency
as we move forward to implement the
provisions of the IMPACT Act and plan
to continue to engage stakeholders to
ensure that our approach to
implementation is communicated in an
open and informative manner.
Comment: Two commenters requested
that CMS consider the CARE–C and
CARE–F items based on the National
Outcomes Measurement System
(NOMS) to capture communication,
cognition, and swallowing as additional
measures to be adopted in post-acute
care settings for future measures. One
commenter encourages CMS and other
measure developers to consider
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functional items such as velocity or gait
speed which may provide a more
meaningful picture of the quality of
mobility performance versus ambulation
distance.
Response: We note that comments on
the addition of areas of function,
including cognition, communication,
and swallowing are addressed further in
section III.D.3.e. iii., Quality Measure
Addressing the Domain of Functional
Status, Cognitive Function, and Changes
in Function and Cognitive Function:
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;
endorsed on July 23, 2015). We
appreciate the suggestion that we
consider functional items such as
velocity or gait speed which may
provide a more meaningful picture of
the quality of mobility performance
versus ambulation distance. We will
consider these recommendations in our
item and measure development and
testing efforts for both measure
development as well as standardized
assessment domain development.
g. Form, Manner, and Timing of Quality
Data Submission
(1) Participation/Timing for New SNFs
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Beginning with the submission of data
required for the FY 2018 payment
determination, we proposed that a new
SNF would be required to begin
reporting data on any quality measures
finalized for that program year by 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. For example,
for FY 2018 payment determinations, if
a SNF received its CCN on August 28,
2016, and 30 days are added (for
example, August 28 + 30 days =
September 27), the SNF would be
required to submit data for residents
who are admitted beginning on October
1, 2016.
We invited public comments on this
proposed timing for new SNFs to begin
reporting quality data under the SNF
QRP. However we received no
comments on this proposal.
Final Decision: We are finalizing our
proposal pertaining to the Participation/
Timing for New SNFs as proposed.
(2) Data Collection Timelines and
Requirements for the FY 2018 Payment
Determination and Subsequent Years
As discussed previously, we proposed
that SNFs would submit data on the
proposed functional status, skin
integrity, and incidence of major falls
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measures by completing items on the
MDS and then submitting the MDS to
CMS through the Quality Improvement
and Evaluation System (QIES),
Assessment Submission and Processing
System (ASAP) system. We sought
comment on the proposed method of
data collection.
We received no comments on the use
of the MDS as the proposed method for
data collection and the QIES ASAP
system for data submission. Therefore,
we are finalizing this approach as
proposed.
Currently, there is no discharge
assessment required when a resident is
discharged from the SNF Medicare Part
A covered stay but does not leave the
facility, and we are aware that this
affects nearly 30 percent of all SNF
residents. To collect the data at the time
these beneficiaries are discharged from
the SNF Part A covered stay, we
proposed to add an item set in addition
to the 5-Day PPS Assessment. Further,
to collect the data elements required to
calculate the function quality measure
(an 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;
endorsed on July 23, 2015]) at the time
of a residents admission, we also
proposed to add the necessary items to
the 5-day PPS Assessment.
A list of the data items that we are
proposed to add to the SNF PPS Part A
Discharge and the 5-Day PPS
Assessments is available on our Web
site at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting-ProgramMeasures-and-TechnicalInformation.html. We recognize that
there may be instances where SNFs
want to combine the SNF PPS Part A
Discharge Assessment with other
required assessments, as happens with
other PPS and OBRA assessments, or
scenarios in which the end of the Part
A covered stay occurs at the same time
as a scheduled PPS assessment.
Therefore, we invited public comment
on any situations where assessments
may be combined or interact, which
should be considered in implementing
the SNF PPS Part A Discharge
Assessment with a view toward
addressing any issues that we may
identify through the public comment
process as requiring additional
clarification.
We invited public comments on our
proposed SNF QRP Data Collection
Requirements for the FY 2018 Payment
Determination and Subsequent Years.
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Comment: One commenter
recommended that CMS shorten the
MDS discharge assessment to only
information needed to construct the
measures since the information will not
be used in patient care, suggesting that
its use pertained to the IMPACT Act
requirements for collecting information
at admission and discharge for
measurement purposes. The commenter
also recommended that the OBRA
Admission assessment should be
completed as a dually coded assessment
with the PPS 5-day assessments in order
that admission assessments for
measures are aligned for all Medicare
and Non-Medicare beneficiaries, such as
Medicare Advantage beneficiaries.
Response: The discharge assessment
is intended to collect the standardized
data used to calculate the measures.
Therefore, the SNF PPS Part A
Discharge includes only the discharge
assessment data needed to inform
current and future SNF QRP measures
and the calculation of those measures.
With regard to the commenter’s
recommendation that the OBRA
Admission assessment be dually coded
with the 5-day assessment, we note that
this type of combination is possible
under the current system, though not
required.
Comment: Several commenters
suggested that the MDS was designed as
an assessment for adults and does not
address the needs of individuals under
21 years of age, specifically children
with complex medical needs like an
intellectual or developmental disability.
Though NFs that treat pediatric
residents complete the MDS for those
residents, it is not an appropriate tool to
measure resident needs or to use as the
basis of a comprehensive care plan for
pediatric residents. Thus, the
commenter requested that pediatric NFs
be exempted from completing the MDS
for their residents, and that data from
the MDS not be utilized for the quality
measures of pediatric NFs, or that CMS
adopt an assessment instrument for
pediatric SNFs that reflect the unique
areas of focus.
In addition, one commenter suggests
that residents of a sub-acute SNF unit
are at elevated risk for medical
complications due to their chronic,
long-term, acute illnesses, when
compared to residents of other SNF
units. Due to the differences between
residents of sub-acute SNF units and
‘‘regular’’ SNFs, the commenter requests
that an additional field be added to the
MDS to identify sub-acute SNF
residents.
Response: The MDS was designed
with numerous groups in mind,
including pediatric nursing home
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residents and their caregivers. In
addition, data submission to CMS for
the purposes of the SNF QRP requires
the submission of such data while the
resident is under a Part A covered stay.
Regarding the comment on sub-acute
units, we will take the recommendation
into consideration.
Comment: One commenter expressed
concerns about the accuracy of the MDS
data that will be used to calculate the
new quality measures. The commenter
noted that the MDS 3.0 Focused Survey
Pilot conducted by CMS found ‘‘room
for improvement in MDS 3.0 assessment
agreement with a resident’s medical
record, especially in the reporting of the
severity and frequency of falls, late loss
ADL status, pressure ulcer status,
restraint use, and coding of certain
diagnoses including UTI.’’ The
commenter suggested that additional
steps are necessary to improve data
accuracy, such as revising and testing
revisions to the survey protocol, drafting
additional guidance and requiring
additional training for surveyors,
conducting special surveys of resident
assessments, reporting on Nursing
Home Compare when data are invalid,
and promulgating regulations to require
penalties for violations of assessment
requirements.
Response: We agree that training is
critical to assure both provider accuracy
and understanding of the assessment
and data collection requirements. We
appreciate the commenter’s suggestions
pertaining to use of various means to
ensure accuracy, such as surveyorrelated protocols and activities as well
as the use of Nursing Home Compare for
the reporting of data and will take these
into consideration. We discuss below
our intention to develop a data
validation program to ensure that SNF
QRP data is accurately reported.
Comment: One commenter expressed
that it is unclear about the timeframe in
which additional items will be added to
the MDS item sets. The commenter
recommended that CMS standardize
and align the PAC assessments (MDS,
OASIS, IRF–PAI, and LTCH–CARE)
prior to finalizing the proposed quality
measures. The commenter suggested
that after the PAC assessments are
aligned, CMS should utilize a period of
testing for the proposed measures. The
commenter also suggested that the
quarterly reporting of claims data
requires that hospital claims and PAC
provider claims be tracked
simultaneously and will likely delay the
production of data which can be
reported to providers if provider claims
are not submitted in a timely manner.
Response: We appreciate the
commenter’s interest in clarification on
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the timelines related to implementation
of the assessment changes required for
the submission of the standardized data
for measures finalized in this rule. The
implementation of the revised
assessment instruments for data
collection of the finalized measures is
October 1, 2016. We appreciate the
suggestion to standardize the post-acute
assessment instruments prior to
finalizing the measures; however, such
an approach may not be feasible when,
for example, the modification of the
instruments is a result of a new measure
using new items. In that instance,
rulemaking is necessary to finalize such
measures before subsequent assessment
changes can be determined. That said,
we will attempt to develop measures
where appropriate from existing items.
We agree that testing is imperative and
through ongoing measure development
and maintenance we apply such testing
and intend to continue to do so.
Additionally, we attempt to use
endorsed measures where able,
however, under certain circumstances,
for reasons discussed earlier and under
our authority to do so, we may elect to
propose measures that are not endorsed.
We appreciate the commenter’s concern
regarding the quarterly reporting of
claims data and potential delays,
although we do not foresee such an
issue. Nonetheless, we will monitor for
this possibility.
Comment: Several commenters
suggested that we had inaccurately
estimated the economic impact
associated with the burden of collection
of the new assessment items used to
calculate the proposed quality
measures. Commenters suggested that
the assessment of 0.5 minutes of nursing
staff time per each new item was too
low because it didn’t take into account
the time for a beneficiary to complete
tasks associated with self-care or
mobility, or the time necessary to
navigate through a data entry system.
One commenter also noted that the
function items take into account a
person’s usual function, over the course
of days 1 to 3 days, which they feel
implies that activities need to be
assessed multiple times, adding burden.
Another commenter stated that the
economic impact analysis did not
account for staff training. Similarly,
commenters stated that the economic
analysis did not factor in the providers’
software and hardware costs. We also
received a comment pertaining to
changes in payer source during a
resident’s stay, noting a concern that
adding additional payer sources could
also add additional burden. We also
received a comment requesting that
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CMS provide additional payment to the
providers during the time that they
implement the new assessment items.
Response: We appreciate the concerns
related to the assessment of costs
associated with the data collection for
the SNF QRP. In response to
commenters’ concerns regarding our
estimate of nursing facility staff time per
item, we would like to clarify that this
is an estimate only of the time spent
determining and documenting the score
following the observation of the patient.
The burden-related estimates used to
evaluate the economic impact are based
on assessment data coding and would
not take into account computer system
delays or other such features. In
response to the comment regarding
multiple assessments required to assess
usual function by the new section GG
function items, we would like to clarify
that only one score is reported for each
item in section GG, the resident’s usual
performance. Clinicians assess the
resident’s functional abilities once or
several times during an assessment
period as part of routine practice.
Consistent with the current function
items in the MDS (section G), section
GG considers the resident’s ability to
perform an activity across the entire
assessment period. Such clinical
assessment and data collection is based
upon customary and best practices that
we believe would be occurring. We also
note that, to minimize burden on
providers, these items are only required
for data collection at the time of
admission and discharge. Further, to
ensure minimal burden the new items
found in section GG, we include several
gateway questions that allow the
clinician to skip questions in the data
set that are not appropriate for an
individual patient in order to reduce
burden. We have instituted skip options
so that the final number of items
assessed per patient is limited
depending on their complexity and
capabilities. Therefore, although all of
the items are available for assessment,
we have built in mechanism that
enables the assessor to include
assessment information as, and when,
appropriate.
With regard to the commenter’s
concerns surrounding training and
software/hardware costs, we recognize
that with item set changes, there are
necessary training and software updates
that may be needed. Although the
burden estimate would not be a
reflection of individual provider
training needs, or those related to
software and hardware, we do include
in the cost estimates cost pertaining to
overhead. That said, CMS provides free
of charge the submission specifications,
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as well as free, downloadable software
to providers and we intend to provide
provider based training that would be
free of charge, as we have done in the
past. With regard to increased costs
associated with all payer data capture,
there already exists administrativerelated data capture in the MDS 3.0, and
therefore, such data capture, should we
require all payer data in the future,
would not come with additional burden.
We believe that we have accounted
for the costs of reporting data in our
burden estimates, as they are doubled to
provide for overhead and fringe
benefits, which should include costs
associated with any required staff
training related to the collection of new
items. However, additionally, we do not
include in our burden estimates the
time that it takes providers to enter the
data into their systems, as this is a part
of routine clinical care and medical
charting, and the data we require
providers to report is routine in this
respect as well.
Having carefully considered the
comments we received on our proposal
pertaining to the Data Collection
Requirements for the FY 2018 Payment
Determination and Subsequent Years,
we are finalizing the policy as proposed.
For the FY 2018 payment
determination, we proposed that SNFs
submit data on the three proposed
quality measures for residents who are
admitted to the SNF on and after
October 1, 2016, and discharged from
the SNF up to and including December
31, 2016, using the data submission
schedule that we proposed in this
section.
We proposed to collect a single
quarter of data for FY 2018 to remain
consistent with the usual October
release schedule for the MDS, to give
SNFs a sufficient amount of time to
update their systems so that they can
comply with the new data reporting
requirements, and to give CMS a
sufficient amount of time to determine
compliance for the FY 2018 program.
The proposed use of one quarter of data
for the initial year of quality reporting
is consistent with the approach we used
to implement a number of other QRPs,
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including the LTCH, IRF, and Hospice
QRPs.
We also proposed that following the
close of the reporting quarter, October 1,
2016, through December 31, 2016, for
the FY 2018 payment determination,
SNFs would have an additional 51⁄2
months to correct and/or submit their
quality data. Consistent with the IRF
QRP, we proposed that the final
deadline for submitting data for the FY
2018 payment determination would be
May 15, 2017. We further proposed that
for the FY 2019 payment determination,
we would collect data from the 2nd
through 4th quarters of FY 2017 (that is,
data for residents who are admitted
from January 1st and discharged up to
and including September 30th) to
determine whether a SNF has met its
quality reporting requirements for that
FY. Beginning with the FY 2020
payment determination, we proposed to
move to a full year of FY data collection.
We intended to propose the FY 2019
payment determination quality
reporting data submission deadlines in
future rulemaking.
TABLE 11—PROPOSED MEASURES, DATA COLLECTION SOURCE, DATA COLLECTION PERIOD AND DATA SUBMISSION
DEADLINES AFFECTING THE FY 2018 PAYMENT DETERMINATION
Data
collection
source
Quality measure
NQF #0678: Percent of Patients or Residents with Pressure Ulcers that
are New or Worsened.
NQF #0674: Application of Percent of Residents Experiencing One or
More Falls with Major Injury (Long Stay).
NQF #2631:* Application of Percent of Long-Term Care Hospital Patients
with an Admission and Discharge Functional Assessment and a Care
Plan that Addresses Function.
Proposed data collection
period
Proposed data submission deadline for FY
2018 payment
determination
MDS
10/01/16–12/31/16
May 15, 2017.
MDS
10/01/16–12/31/16
May 15, 2017.
MDS
10/01/16–12/31/16
May 15, 2017.
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* Status: NQF-endorsed on July 23, 2015, please see: https://www.qualityforum.org/ProjectMeasures.aspx?projectID=73867, see NQF #2631.
We invited public comment on
Proposed Measures, Data Collection
Source, Data Collection Period and Data
Submission Deadlines Affecting the FY
2018 Payment Determination. The
comments we received on this topic,
with their responses, appear below.
Comment: One commenter expressed
support for CMS’s proposed timing for
new SNFs to begin reporting quality
data. One commenter requested that
data from the MDS be made publicly
available sooner than 2 years after the
specified application date for the
measure. The commenter suggested that
collecting only one quarter of data
between October 1 and December 31,
2016 is not sufficient to establish data
trending. The commenter requested that
at least 2 quarters be used for FY 2018
payment determination, and by FY 2019
a full year’s worth of data should be
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used. Another commenter expressed
that facilities should not be given 51⁄2
months to submit or correct their
quarterly data.
Response: We appreciate the
suggestion regarding extending the
timing of data collection to establish
sufficient data trending. We proposed to
collect a single quarter of data for FY
2018 to remain consistent with the
usual October release for the MDS, to
give SNFs a sufficient amount of time to
update their systems so that they can
comply with the new data reporting
requirements, and to give CMS a
sufficient amount of time to determine
compliance for the FY 2018 program.
The proposed use of one quarter of data
for the initial year of quality reporting
is consistent with the approach we used
to implement a number of other QRPs,
including LTCH, IRF, and Hospice
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QRPs. With regard to the 51⁄2 month
post-data collection period, this
Proposed Data Submission timeframe
and final deadline for FY 2018 Payment
Determination is to allow providers an
opportunity to ensure that the data from
the collection period has been
submitted and is accurate and
corrections, where necessary, have been
made. We have aligned these
timeframes with the LTCH, and IRF and
other QRPs. We appreciate and will take
into consideration the commenter’s
suggestion to implement public
reporting sooner.
Final Decision: Having carefully
considered the comments we received
on Proposed Measures, Data Collection
Source, Data Collection Period and Data
Submission Deadlines Affecting the FY
2018 Payment Determination we are
finalizing the policy as proposed.
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h. SNF QRP Data Completion
Thresholds for the FY 2018 Payment
Determination and Subsequent Years
We proposed that, beginning with the
FY 2018 payment determination, SNFs
must report all of the data necessary to
calculate the proposed quality measures
on at least 80 percent of the MDS
assessments that they submit. We
proposed that a SNF has reported all of
the data necessary to calculate the
measures if the data actually can be
used for purposes of calculating the
quality measures, as opposed to, for
example, the use of a dash [-], to
indicate that the SNF was unable to
perform a pressure ulcer assessment.
We believe that because SNFs have
long been required to submit MDS
assessments for other purposes, SNFs
should easily be able to meet this
proposed requirement for the SNF QRP.
Our proposal to set reporting thresholds
is consistent with policies we have
adopted for the Long-Term Care
Hospital (79 FR 50314), InpatientRehabilitation Hospital (79 FR 45923)
and Home Health (79 FR 66079) QRPs.
Although we proposed to adopt an 80
percent threshold initially, we stated
our intention to propose to raise the
threshold level for subsequent program
years through future rulemaking.
We also proposed that for the FY 2018
SNF QRP, any SNF that does not meet
the proposed requirement that 80
percent of all MDS assessments
submitted contain 100 percent of all
data items necessary to calculate the
SNF QRP measures would be subject to
a reduction of 2 percentage points to its
FY 2018 market basket percentage.
We invited comment on the proposed
SNF QRP data completion requirements.
The comments we received on this
topic, with their responses, appear
below.
Comment: One commenter expressed
support for the application of a 2
percent penalty for incomplete reporting
of the quality data necessary to calculate
NQF endorsed measures. This
commenter states that this support
extends only to those measures with
NQF endorsement as they believe that
the 2 percent incentive would ensure
that providers are collecting data
necessary to implement the IMPACT
Act.
Response: Section 1888(e)(6)(A)(i) of
the Act requires that, for FYs beginning
with FY 2018, if a SNF does not submit
data, as applicable, on quality and
resource use and other measures in
accordance with section
1888(e)(6)(B)(i)(II) of the Act and
standardized patient assessment in
accordance with section
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1888(e)(6)(B)(i)(III) of the Act for such
FY, the Secretary must reduce the SNF’s
market basket percentage described in
section 1888(e)(5)(B)(ii) of the Act by 2
percentage points. As we have
discussed above, we are not limited to
adopting for the SNF QRP only
measures that have been endorsed by
the NQF, and to the extent that a SNF
fails to satisfactorily report one or more
SNF QRP measures that are not NQFendorsed, we would be statutorily
obligated to reduce the SNF’s market
basket percentage for the applicable
fiscal year by 2 percentage points.
Comment: One commenter does not
support the proposed 80 percent
threshold for completion of all of the
data necessary to calculate the quality
measure. This commenter expressed
concern that data could be omitted
resulting in negative quality measure
results. Their recommendation is to
increase the threshold to 90 percent.
Another commenter recommended
lowering the threshold from 80 percent
to 40 percent during the first 2 years of
data collection.
Response: Our proposal to set
reporting thresholds is consistent with
policies we have adopted for the LongTerm Care Hospital (79 FR 50314),
Inpatient-Rehabilitation Hospital (79 FR
45923) and Home Health (79 FR 66079)
QRPs. SNF providers have been
submitting the MDS for many years and
we disagree that we should lower the
submission threshold as suggested.
However, we intend to reevaluate our
threshold over time and will propose to
modify it, if warranted, based on our
analysis.
Comment: One commenter requested
clarification on what constitutes data
that is ‘‘satisfactorily’’ submitted.
Response: We are finalizing that data
will have been satisfactorily submitted
for the FY 2018 SNF QRP if the SNF has
reported all of the data necessary to
calculate the finalized measures and
that the data can actually be used for
purposes of calculating the quality
measures, as opposed to, for example,
the use of a dash [-], to indicate that the
SNF was unable to perform a pressure
ulcer assessment.
After consideration of the public
comments received, we are finalizing
the adoption of the policy for SNF QRP
Data Completion Thresholds for the FY
2018 Payment Determination and
Subsequent Years as proposed.
i. SNF QRP Data Validation
Requirements for the FY 2018 Payment
Determination and Subsequent Years
To ensure the reliability and accuracy
of the data submitted under the SNF
QRP, we proposed to adopt policies and
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processes for validating the data
submitted under the SNF QRP in future
rulemaking. We received the following
comments on elements we should
consider including in such a process:
Comment: One commenter expressed
concern that CMS is not ensuring that
the data submitted by SNFs is accurate.
Specifically, the commenter suggested
that self-reported MDS data are
unreliable and are subject to gaming and
that a variety of media outlets and CMS
itself have reported on data accuracy
concerns. The commenter suggested that
facilities may electively omit data for
residents whose health is deteriorating.
The commenter supported CMS asking
for the identification of elements to
validate the data that SNFs submit and
suggested several ways that CMS may
validate the data. Another commenter
recommended that CMS revisit the 2014
MDS-focused survey process assessing
MDS Version 3.0 coding practices to
help inform SNF QRP validation
requirements.
Response: We appreciate the concerns
pertaining to gaming and note that we
will apply a threshold for reporting of
complete resident data for the FY 2018
SNF QRP. As part of our compliance
analysis, we intend to carefully monitor
rates of missing data across all facilities.
Further, we intend to align with other
QRPs and propose through future
rulemaking data validation policies.
Comment: One commenter suggested
several recommendations for elements
CMS should include to ensure the
reliability and accuracy of data
submitted for the SNF QRP. CMS
should explore a combination of pure
data checks to identify inconsistencies
that exist between items relevant to the
SNF QRP and other items reported in
the MDS and audit suspicious data
patterns. Another commenter suggested
providing a list of validation checks that
could be used by both providers and
vendors to help improve the accuracy of
data. Another commenter recommended
public reporting on Nursing Home
Compare when facilities submit invalid
data and stricter regulations that require
specific penalties for violations of
resident assessment requirements.
Response: We appreciate the
commenters’ suggestions to ensure data
accuracy such as a combination of pure
data checks to identify inconsistencies.
We agree with this approach and intend
to perform such monitoring as part of
overall programmatic monitoring and
evaluation. We encourage providers to
engage in available opportunities to
improve the accuracy of their data. We
appreciate the suggestion that we make
public on Nursing Home Compare when
facilities submit to CMS invalid data,
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and will also take under consideration
the suggestion that we implement
additional regulatory requirements on
this issue.
We thank the commenters for their
input on policies that we should
consider pertaining to data validation
and accuracy analysis.
j. SNF QRP Submission Exception and
Extension Requirements for the FY 2018
Payment Determination and Subsequent
Years
Our experience with other QRPs has
shown that there are times when
providers are unable to submit quality
data due to extraordinary circumstances
beyond their control (for example,
natural, or man-made disasters). Other
extenuating circumstances are reviewed
on a case-by-case basis. We have
defined a ‘‘disaster’’ as any natural or
man-made catastrophe which causes
damages of sufficient severity and
magnitude to partially or completely
destroy or delay access to medical
records and associated documentation.
Natural disasters could include events
such as hurricanes, tornadoes,
earthquakes, volcanic eruptions, fires,
mudslides, snowstorms, and tsunamis.
Man-made disasters could include such
events as terrorist attacks, bombings,
floods caused by man-made actions,
civil disorders, and explosions. A
disaster may be widespread and impact
multiple structures or be isolated and
impact a single site only.
In certain instances of either natural
or man-made disasters, a SNF may have
the ability to conduct a full resident
assessment, and record and save the
associated data either during or before
the occurrence of the extraordinary
event. In this case, the extraordinary
event has not caused the facility’s data
files to be destroyed, but it could hinder
the SNF’s ability to meet the QRP’s data
submission deadlines. In this scenario,
the SNF would potentially have the
ability to report the data at a later date,
after the emergency has passed. In such
cases, a temporary extension of the
deadlines for reporting might be
appropriate.
In other circumstances of natural or
man-made disaster, a SNF may not have
had the ability to conduct a full resident
assessment, or to record and save the
associated data before the occurrence of
the extraordinary event. In such a
scenario, the facility may not have
complete data to submit to CMS. We
believe that it may be appropriate, in
these situations, to grant a full exception
to the reporting requirements for a
specific period of time.
We do not wish to penalize SNFs in
these circumstances or to unduly
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increase their burden during these
times. Therefore, we proposed a process
for SNFs to request and for us to grant
exceptions and extensions with respect
to the quality data reporting
requirements of the SNF QRP for one or
more quarters, beginning with the FY
2018 payment determination, when
there are certain extraordinary
circumstances beyond the control of the
SNF. When an exception or extension is
granted, we would not reduce the SNF’s
PPS payment for failure to comply with
the requirements of the SNF QRP.
We proposed that if a SNF seeks to
request an exception or extension for
the SNF QRP, the SNF should request
an exception or extension within 90
days of the date that the extraordinary
circumstances occurred. The SNF may
request an exception or extension for
one or more quarters by submitting a
written request to CMS that contains the
information noted below, via email to
the SNF Exception and Extension
mailbox at SNFQRPReconsiderations@
cms.hhs.gov. Requests sent to CMS
through any other channel will not be
considered as valid requests for an
exception or extension from the SNF
QRP’s reporting requirements for any
payment determination.
We note that the subject of the email
must read ‘‘SNF QRP Exception or
Extension Request’’ and the email must
contain the following information:
• SNF CCN;
• SNF name;
• CEO or CEO-designated personnel
contact information including name,
telephone number, email address, and
mailing address (the address must be a
physical address, not a post office box);
• SNF’s reason for requesting an
exception or extension;
• Evidence of the impact of
extraordinary circumstances, including
but not limited to photographs,
newspaper and other media articles; and
• A date when the SNF believes it
will be able to again submit SNF QRP
data and a justification for the proposed
date.
We proposed that exception and
extension requests be signed by the
SNF’s CEO or CEO-designated
personnel, and that if the CEO
designates an individual to sign the
request, the CEO-designated individual
has the appropriate authority to submit
such a request on behalf of the SNF.
Following receipt of the email, we will:
(1) Provide a written acknowledgement,
using the contact information provided
in the email, to the CEO or CEOdesignated contact notifying them that
the request has been received; and (2)
provide a formal response to the CEO or
any CEO-designated SNF personnel,
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46459
using the contact information provided
in the email, indicating our decision.
This proposal does not preclude us
from granting exceptions or extensions
to SNFs that have not requested them
when we determine that an
extraordinary circumstance, such as an
act of nature, affects an entire region or
locale. If we make the determination to
grant an exception or extension to all
SNFs in a region or locale, we proposed
to communicate this decision through
routine communication channels to SNF
s and vendors, including, but not
limited to, issuing memos, emails, and
notices on our SNF QRP Web site once
it is available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
NursingHomeQualityInits/SNF-QRReconsideration-andExceptionExtension.html.
We also proposed that we may grant
an exception or extension to SNFs if we
determine that a systemic problem with
one of our data collection systems
directly affected the ability of the SNF
to submit data. Because we do not
anticipate that these types of systemic
errors will happen often, we do not
anticipate granting an exception or
extension on this basis frequently.
If a SNF is granted an exception, we
will not require that the SNF submit any
measure data for the period of time
specified in the exception request
decision. If we grant an extension to a
SNF, the SNF will still remain
responsible for submitting quality data
collected during the timeframe in
question, although we will specify a
revised deadline by which the SNF
must submit this quality data.
We also proposed that any exception
or extension requests submitted for
purposes of the SNF QRP will apply to
that program only, and not to any other
program we administer for SNFs such as
survey and certification. MDS
requirements, including electronic
submission, during Declared Public
Health Emergencies can be found at
FAQs K–5, K–6, and K–9 on the
following link: https://www.cms.gov/
Medicare/Provider-Enrollment-andCertification/SurveyCertEmergPrep/
downloads/AllHazardsFAQs.pdf.
We intend to provide additional
information pertaining to exceptions
and extensions for the SNF QRP,
including any additional guidance, on
the SNFQRP Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-QR-Reconsideration-andExceptionExtension.html. We invited
public comment on these proposals for
seeking and being granted exceptions
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and extensions to the quality reporting
requirements. The following is a
summary of the comments received and
our responses.
Comment: Many commenters
expressed strong support for the
creation of an exception and extension
request process for SNFs that experience
disasters or other extraordinary
circumstances.
Response: We thank the commenters
for their comments and support.
After consideration of the public
comments received, we are finalizing
the adoption of the policy for SNF QRP
Submission Exception and Extension
Requirements for the FY 2018 Payment
Determination and Subsequent Years.
k. SNF QRP Reconsideration and
Appeals Procedures for the FY 2018
Payment Determination and Subsequent
Years
At the conclusion of the required
quality data reporting and submission
period, we will review the data received
from each SNF during that reporting
period to determine if the SNF met the
quality data reporting requirements.
SNFs that are found to be noncompliant
with the reporting requirements for the
applicable FY will receive a 2
percentage point reduction to their
market basket percentage update for that
FY.
We are aware that some of our other
QRPs, such as the HIQR Program, the
LTCHQR Program, and the IRF QRP
include an opportunity for the providers
to request a reconsideration of our
initial non-compliance determination.
Therefore, to be consistent with other
established QRPs and to provide an
opportunity for SNFs to seek
reconsideration of our initial noncompliance decision, we proposed a
process that will enable a SNF to
request reconsideration of our initial
non-compliance decision in the event
that it believes that it was incorrectly
identified as being non-compliant with
the SNF QRP reporting requirements for
a particular FY.
For the FY 2018 payment
determination, and that of subsequent
years, we proposed that a SNF would
receive a notification of noncompliance
if we determine that the SNF did not
submit data in accordance with the data
reporting requirements with respect to
the applicable FY. The purpose of this
notification is to put the SNF on notice
of the following: (1) That the SNF has
been identified as being non-compliant
with the SNF QRP’s reporting
requirements for the applicable FY; (2)
that the SNF will be scheduled to
receive a reduction in the amount of two
percentage points to its market basket
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percentage update for the applicable FY;
(3) that the SNF may file a request for
reconsideration if it believes that the
finding of noncompliance is erroneous,
has submitted a request for an extension
or exception that has not yet been
decided, or has been granted an
extension or exception; and (4) that the
SNF must follow a defined process on
how to file a request for reconsideration,
which will be described in the
notification. We would only consider
requests for reconsideration after an
SNF has been found to be
noncompliant.
Notifications of noncompliance and
any subsequent notifications from CMS
would be sent via a traceable delivery
method, such as certified U.S. mail or
registered U.S. mail, or through other
practicable notification processes, such
as a report from CMS to the provider as
a Certification and Survey Provider
Enhanced Reports (CASPER) report, that
will provide information pertaining to
their compliance with the reporting
requirements for the given reporting
cycle. To obtain the CASPER report,
providers should access the CASPER
Reporting Application. Information on
how to access the CASPER Reporting
Application is available on the Quality
Improvement Evaluation System (QIES)
Technical Support Office Web site
(direct link), https://web.qiesnet.org/
qiestosuccess/. Once access is
established providers can select
‘‘CASPER Reports’’ link. The ‘‘CASPER
Reports’’ link will connect a SNF to the
QIES National System Login page for
CASPER Reporting.
We invited comments on the most
preferable delivery method for the
notice of non-compliance, such as U.S.
Mail, email, CASPER, etc. The
comments we received on this topic,
with their responses, appear below.
Comment: One commenter suggested
the use of QIES to communicate notices
of non-compliance. Another commenter
suggested that non-compliance
notifications be sent via multiple
mechanisms to ensure delivery,
including CASPER reports and a
traceable delivery method.
Response: We intend to provide
further guidance regarding the delivery
method for the notices of noncompliance in future rulemaking.
We proposed to disseminate
communications regarding the
availability of compliance reports in the
CASPER reports through routine
channels to SNFs and vendors,
including, but not limited to issuing
memos, emails, Medicare Learning
Network (MLN) announcements, and
notices on our SNF QRP Web site once
it is available at https://www.cms.gov/
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Medicare/Quality-Initiatives-PatientAssessment-Instruments/
NursingHomeQualityInits/SNF-QRReconsideration-andExceptionExtension.html.
A SNF would have 30 days from the
date of the initial notification of
noncompliance to submit to us a request
for reconsideration. This proposed time
frame allows us to balance our desire to
ensure that SNFs have the opportunity
to request reconsideration with our need
to complete the process and provide
SNFs with our reconsideration decision
in a timely manner. We proposed that
a SNF may withdraw its request at any
time and may file an updated request
within the proposed 30-day deadline.
We also proposed that, in very limited
circumstances, we may grant a request
by a SNF to extend the proposed
deadline for reconsideration requests. It
would be the responsibility of a SNF to
request an extension and demonstrate
that extenuating circumstances existed
that prevented the filing of the
reconsideration request by the proposed
deadline.
We also proposed that as part of the
SNF’s request for reconsideration, the
SNF would be required to submit all
supporting documentation and evidence
demonstrating full compliance with all
SNF QRP reporting requirements for the
applicable FY, that the SNF has
requested an extension or exception for
which a decision has not yet been made,
that the SNF has been granted an
extension or exception, or has
experienced an extenuating
circumstance as defined in section
III.D.3.j. of this rule but failed to file a
timely request of exception. We
proposed that we would not review any
reconsideration request that fails to
provide the necessary documentation
and evidence along with the request.
The documentation and evidence may
include copies of any communications
that demonstrate the SNF’s compliance
with the SNF QRP, as well as any other
records that support the SNF’s rationale
for seeking reconsideration, but should
not include any protected health
information (PHI). We intended to
provide a sample list of acceptable
supporting documentation and
evidence, as well as instructions for
SNFs on how to retrieve copies of the
data submitted to CMS for the
appropriate program year in the future
on our SNF QRP Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-QR-Reconsideration-andExceptionExtension.html.
We proposed that a SNF wishing to
request a reconsideration of our initial
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noncompliance determination would be
required to do so by submitting an email
to the following email address:
SNFQRPReconsiderations@cms.hhs.gov.
Any request for reconsideration
submitted to us by a SNF would be
required to follow the guidelines
outlined on our SNF QRP Web site once
it is available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
NursingHomeQualityInits/SNF-QRReconsideration-andExceptionExtension.html.
All emails must contain a subject line
that reads ‘‘SNF QRP Reconsideration
Request.’’ Electronic email submission
is the only form of reconsideration
request submission that will be accepted
by us. Any reconsideration requests
communicated through another channel
including, but not limited to, U.S. Postal
Service or phone, will not be considered
as a valid reconsideration request.
We proposed that a reconsideration
request include the following
information:
• SNF CMS Certification Number
(CCN);
• SNF Business Name;
• SNF Business Address;
• The CEO contact information
including name, email address,
telephone number and physical mailing
address; or
The CEO-designated representative
contact information including name,
title, email address, telephone number
and physical mailing address; and
• CMS identified reason(s) for noncompliance from the non-compliance
notification; and
• The reason(s) for requesting
reconsideration
The request for reconsideration must
be accompanied by supporting
documentation demonstrating
compliance.
Following receipt of a request for
reconsideration, we will provide an
email acknowledgment, using the
contact information provided in the
reconsideration request, to the CEO or
CEO-designated representative that the
request has been received. Once we
have reached a decision regarding the
reconsideration request, an email will
be sent to the SNF CEO or CEOdesignated representative, using the
contact information provided in the
reconsideration request, notifying the
SNF of our decision.
We also proposed that the
notifications of our decision regarding
reconsideration requests may be made
available through the use of CASPER
reports or through a traceable delivery
method, such as certified U.S. mail or
registered U.S. mail. If the SNF is
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dissatisfied with the decision rendered
at the reconsideration level, the SNF
may appeal the decision to the PRRB
under 42 CFR 405.1835. We believe this
proposed process is more efficient and
less costly for CMS and for SNFs
because it decreases the number of
PRRB appeals by resolving issues earlier
in the process. Additional information
about the reconsideration process
including details for submitting a
reconsideration request will be posted
in the future to our SNF QRP Web site
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-QR-Reconsideration-andExceptionExtension.html. We invited
public comment on the proposed
procedures for reconsideration and
appeals. The following is a summary of
the comments received and our
responses.
Comment: Many commenters
supported the policy to allow SNFs an
opportunity to submit reconsideration
requests. One commenter recommended
extending the appeal timeline from 30
to 45 days if CMS does not provide for
a timely notification method.
Response: To remain consistent with
our other QRPs which have successfully
implemented a reconsideration process,
we believe that 30 days is sufficient.
Final Decision: After consideration of
the public comments received, we are
finalizing the adoption of the policy for
SNF QRP Reconsideration and Appeals
Procedure for the FY 2018 Payment
Determination and Subsequent Years.
l. Public Display of Quality Measure
Data for the SNF QRP
Section 1899B(g)(1) of the Act
requires the Secretary to provide for the
public reporting of SNF provider
performance on the quality measures
specified under subsection (c)(1) and
the resource use and other measures
specified under subsection (d)(1) by
establishing procedures for making
available to the public data and
information on the performance of
individual SNFs with respect to the
measures. Under section 1899B(g)(2) of
the Act, such procedures must be
consistent with those under section
1886(b)(3)(B)(viii)(VII) of the Act and
also allow SNFs the opportunity to
review and submit corrections to the
data and other information before it is
made public. Section 1899B(g)(3) of the
Act requires that the data and
information be made publicly available
not later than 2 years after the specified
application date applicable to such a
measure and provider. Finally, section
1899B(g)(4)(B) of the Act requires such
procedures be consistent with sections
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1819(i) and 1919(i) of the Act. We stated
our intention to propose details related
to the public display of quality
measures in the future. The following is
a summary of the comments received
and our responses.
Comment: One commenter suggested
that CMS replace or add to the existing
measures on Nursing Home Compare
when measures that meet the IMPACT
Act requirements are adopted. This
commenter further suggested
adjustment to the thresholds used in
assigning Star Ratings to the quality
measures, and cautioned CMS to
compare SNFs against performance of
meaningful scores on the quality
measures rather than against their
respective rankings. The commenter
also suggested the formation of a TEP to
develop a method on how to publicly
report in a single cross-setting report
that compares PAC performance across
PAC providers, as well as assist in the
development of meaningful targets on
quality measures. One commenter stated
that the imposition of a financial
penalty should be publicly reported.
Response: We will take these
recommendations into consideration as
we develop the process for the public
display of data and information on the
performance of individual SNFs with
respect to the measures.
m. Mechanism for Providing Feedback
Reports to SNFs
Section 1899B(f) of the Act requires
the Secretary to provide confidential
feedback reports to post-acute care
providers on their performance with
respect to the measures specified under
subsections (c)(1) and (d)(1), beginning
1 year after the specified application
date that applies to such measures and
PAC providers. We intended to provide
detailed procedures to SNFs on how to
obtain their confidential feedback
reports on the SNF QRP Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting.html. The
following is a summary of the comments
received and our responses.
Comment: One commenter
recommended that CMS use the same
mechanism currently used by SNFs for
previewing Five Star data and allow
SNFs to preview all of the quality
measures on Nursing Home Compare.
The commenter also suggested that CMS
use the QIES system so that all SNFs
can preview their individual reports on
a weekly basis.
Response: We will take the suggestion
into consideration as we develop the
mechanism for providing feedback
reports to SNFs.
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4. Staffing Data Collection
a. Background and Statutory Authority
Section 1819(d)(1)(A) of the Act for
SNFs and section 1919(d)(1)(A) of the
Act for NFs each state that, in general,
a facility must be administered in a
manner that enables it to use its
resources effectively and efficiently to
attain or maintain the highest
practicable physical, mental, and
psychosocial well-being of each
resident. Sections 1819(d)(4)(B) and
1919(d)(4)(B) of the Act give the
Secretary authority to issue rules, for
SNFs and NFs respectively, relating to
the health, safety and well-being of
residents and relating to the physical
facilities thereof.
The Affordable Care Act of 2010 (Pub.
L. 111–148, March 23, 2010) added a
new section 1128I to the Act to promote
greater accountability for LTC facilities
(defined under section 1128I(a) of the
Act as SNFs and nursing facilities). As
added by the Affordable Care Act,
section 1128I(g) pertains to the
submission of staffing data by LTC
facilities, and specifies that the
Secretary, after consulting with state
long-term care ombudsman programs,
consumer advocacy groups, provider
stakeholder groups, employees and their
representatives and other parties the
Secretary deems appropriate, shall
require a facility to electronically
submit to the Secretary direct care
staffing information, including
information for agency and contract
staff, based on payroll and other
verifiable and auditable data in a
uniform format according to
specifications established by the
Secretary in consultation with such
programs, groups, and parties. The
statute further requires that the
specifications established by the
Secretary specify the category of work a
certified employee performs (such as
whether the employee is a registered
nurse, licensed practical nurse, licensed
vocational nurse, certified nursing
assistant, therapist, or other medical
personnel), include resident census data
and information on resident case mix,
be reported on a regular schedule, and
include information on employee
turnover and tenure and on the hours of
care provided by each category of
certified employees per resident per
day. Section 1128I(g) of the Act
establishes that the Secretary may
require submission of information for
specific categories, such as nursing staff,
before other categories of certified
employees, and requires that
information for agency and contract staff
be kept separate from information on
employee staffing.
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b. Provisions of the Proposed Rule and
Response to Comments
As part of the FY 2016 SNF PPS
proposed rule, we proposed to
implement the new statutory
requirement in section 1128I(g) of the
Act. Specifically, we proposed to
modify current regulations applicable to
LTC facilities that participate in
Medicare and Medicaid by amending
the requirements for the administration
of a LTC facility at § 483.75 to add a
new paragraph (u), Mandatory
submission of staffing information based
on payroll data in a uniform format.
During the 60-day comment period on
the proposed rule, we received
approximately 22 timely comments on
the staffing data collection proposal
from individuals, providers, national
and regional health care professional
associations and advocacy groups.
Summaries of the proposed provisions,
as well as the public comments and our
responses, are set forth below.
(1) Consultation on Specifications
As discussed in the FY 2016 SNF PPS
proposed rule, we adopted a multipronged strategy to comply with section
1128I(g) of the Act’s consultation
requirement that includes both
soliciting input from all interested
parties through the rulemaking process
and ongoing consultation with the
statutorily identified entities regarding
the sub-regulatory reporting
specifications that we will establish. We
invited public comment on our
proposed methods for consultation on
the submission specifications. The
comments we received on this topic,
with their responses, appear below.
Comment: One commenter suggested
that CMS convene a TEP to design a
structure and to clearly articulate the
goals and purpose of the collected
information prior to mandated
reporting. Another commenter asked
where it indicated in the rule that the
specifications of staffing data would be
based upon ‘‘. . . consultation with
long-term care ombudsman programs,
consumer advocacy groups, provider
stakeholder groups, employees and their
representatives.’’ This commenter
proposed that CMS provide the result of
those consultations with the
aforementioned groups. Commenters
further stated that it would seem such
information could be valuable in the
formation of a rational implementation
of this particular provision of the
Affordable Care Act. Other commenters
stated that the designing of the reporting
process should take into account
differences among LTC providers, such
as variations in size, location,
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management and operations, including
differences among payroll and time and
attendance systems. Those commenters
urged CMS, when implementing this
new requirement, to assure opportunity
for feedback and provider
representation and participation across
the full spectrum of nursing home
structures and organization types, such
as large, small, urban, rural,
freestanding and multiple-site facilities,
as well as regional companies and large
companies.
Response: We are committed to
consulting with stakeholders, including
LTC facilities, consumer advocates, and
other related groups. Through this
rulemaking, we solicited input from all
of the statutorily identified entities and
this final rule reflects the outcome of
that consultation. We are continuing our
consultation on the sub-regulatory
specifications through a variety of
mechanisms. We have a regular
dialogue with stakeholders through
individual and national calls. These
stakeholders represent a wide range of
facilities throughout the country,
including large and small, rural and
urban, independently-owned facilities
and national chains, and we have
consulted with facilities with varying
types of payroll and time keeping
systems. In addition, we published a
Draft Policy Manual (‘‘1.0’’) for the
electronic staffing data submission
payroll-based journal (‘‘Draft PBJ Policy
Manual’’) that offers more details of
planned technical specifications and
invited comments that we continue to
take into account as we develop and
refine the specifications to implement
this final rule. This manual is available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
Staffing-Data-Submission-PBJ.html. We
encourage stakeholders to email
comments and requests to NHStaffing@
cms.hhs.gov as another opportunity for
consultation. We appreciate the
suggestions from commenters on other
mechanisms for consultation with
stakeholders on our subregulatory
specifications and we will consider
these options as we continue our
dialogue and engagement efforts
throughout implementation.
(2) Scope of Submission Requirements
As noted above, section 1128(g) of the
Act mandates that the Secretary require
LTC facilities ‘‘to ‘‘to electronically
submit to the Secretary direct care
staffing information, including
information for agency and contract
staff, based on payroll and other
verifiable and auditable data in a
uniform format.’’ The proposed rule
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used the statutory term ‘‘direct care
staffing information’’ without
elaboration. We received a number of
comments regarding the scope of this
term. Those comments and our
responses are set forth below.
Comment: Several commenters asked
that CMS define ‘‘direct care staff’’ and
clarify the types of staff in the nursing
facilities that are included in this
reporting. Several commenters
recommended we use the following
definition; ‘‘Direct care staff means
those individuals who provide care and
services enabling the resident to receive
the necessary care and services to attain
or maintain the highest practicable
physical, mental, and psychosocial
well-being, in accordance with the
comprehensive assessment and plan of
care, as specified in § 483.25.’’ A few
commenters recommended using the
definition from the preamble of the
October 2005 Final Rule on Posting of
Nurse Staffing Information (70 FR 62065
available at https://www.gpo.gov/fdsys/
pkg/FR-2005-10-28/pdf/05-21278.pdf),
which states that direct care means that
an individual is directly responsible for
resident care, which includes, but is not
limited to, such activities as assisting
with activities of daily living (ADLs),
performing gastro-intestinal feeds,
giving medications, supervising the care
given by CNAs, and performing nursing
assessments to admit residents or notify
physicians about a change in condition.
Another commenter recommended
defining direct care staff as staff having
‘‘hands on’’ care of a patient.
Several commenters expressed
concern that the Draft PBJ Policy
Manual suggested CMS planned to
interpret the proposed regulation to
require reporting of information on nondirect care employees and opined that
this interpretation would go beyond
what Congress intended. One
commenter stated that nowhere in the
Affordable Care Act, or the proposed
rule, is there mention of the non-direct
patient care services as direct care staff.
They opined that some of the employee
categories listed in the Draft PBJ Policy
Manual, such as housekeeping and
dietary, are generally not considered to
be individuals that perform direct care.
Commenters stated that it was not the
intent of Congress to require reporting
for individuals providing non-direct
care services and that CMS’s
interpretation would increase the
burden beyond what is necessary, while
at the same time not adding information
that is helpful to the overall goal of the
program. They stated that the
interpretation by CMS of definitions of
direct care staff in the Draft PBJ Policy
Manual broadens the scope and breadth
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of data required, and does so to an
unnecessary extent that exhibits
overreach of the legislative directive.
They urged CMS to maintain internal
consistency with the definitions in
section 6106 of the Affordable Care Act,
the proposed rule, the Draft PBJ Policy
Manual and ultimately the final rule,
and limit this data collection to direct
patient care staff information.
Commenters stated that the final rule
should clarify that direct care staffing
excludes non-direct care services. In
addition, they recommended that
references to non-direct care services be
removed from the Draft PBJ Policy
Manual to avoid confusion and
unnecessary administrative costs for
providers. Some examples the
commenters provided as extraneous to
the direct care staff normally employed
by nursing homes (and that they advise
should be reevaluated with stakeholder
consultation and input) are blood
service workers and vocational service
workers.
Another commenter urged that CMS
only collect staffing data about direct
care staff that are typically employed (or
contracted by) in nursing centers,
including trained medication aides
(where permitted by state law), and not
all types of staff that are currently
reflected in the CMS Form 671 (for
example, housekeeping staff,
administration and storage of blood,
vocational services). They also
recommended that CMS collect staffing
data about additional direct care staff
such as Certified Respiratory Therapists,
all therapy staff (Speech and Language
Pathologists, Physical Therapists,
Occupational Therapists, PT/OT
Assistants and Aides) therapeutic
recreation staff, medical social workers,
physicians and non-physician
practitioners (NPPs). Another
commenter asked that CMS clearly
delineate all staff categories, including
physical therapist and physical
therapist assistants. Additional
comments request that CMS clarify what
categories of employees are included in
‘‘therapist and other type of medical
personnel’’.
Response: We believe that the
statutory term ‘‘direct care staffing
information’’ as used in the proposed
rule is self-explanatory. As noted in the
preamble to the proposed rule, facilities
have a statutory obligation to be
administered in a manner that enables
it to use its resources efficiently and
effectively to attain or maintain the
highest practicable physical, mental and
psychosocial well-being of each
resident. We also noted that the
statutory requirement to report direct
care staffing information was added to
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promote greater accountability for LTC
facilities in meeting this obligation. In
addition, the Congress gave context for
the term ‘‘direct care staffing
information’’ by including a nonexclusive list of the categories of work
that may be performed by individuals
whose information would be reported.
We incorporated this non-exclusive list
into the proposed rule. Accordingly, we
believe that it was clear from the
proposed rule that the reporting
requirement would apply to the subset
of staff at a LTC facility whose work
directly advances resident well-being.
However, we appreciate commenters
desire to have specificity in the
regulation. Based on the comments
received, in this final rule we add a
definition of ‘‘Direct Care Staff’’ at
§ 483.75(u)(1). This definition is
grounded in the statutory text cited in
the proposed rule and incorporates
specific text offered by commenters.
‘‘Direct Care Staff’’ is defined as those
individuals who, through interpersonal
contact with residents or resident care
management, provide care and services
to residents to allow them to attain or
maintain the highest practicable
physical, mental, and psychosocial
well-being. Direct care staff does not
include individuals whose primary duty
is maintaining the physical environment
of the long term care facility (for
example, housekeeping). In this
definition, we do not exclude
individuals who spend time on duties
that are not always ‘‘hands on,’’ such as
supervising nurses or medication
management, as these types of duties
directly impact a resident’s care.
Therefore, the definition focuses
primarily on whether the staff person in
question provides care or services either
through ‘‘hands on’’ care or through
resident care management, with the
intention of benefiting the resident’s
well-being. We further note that there
can be significant variation in the level
and type of direct care that many staff
provide. For example, a certified nurse
assistant may spend the bulk of their
time delivering hands-on care directly at
the bedside, while an activities director
may spend less time delivering handson bedside care. As such, we intend to
collect staffing data on any staff that
provides any amount of direct care.
Although comments on the Draft PBJ
Policy Manual are beyond the scope of
this rulemaking, we appreciate
commenters’ feedback on how this draft
guidance would implement the
regulatory obligations established under
this rule. We agree with commenters
who stated that the reporting obligation
under this regulation should not extend
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to non-direct care staff, as well as their
assertion that individuals who provide
housekeeping are not direct care staff.
As explained above, we are following
commenters’ recommendation to add a
definition of direct care staff. As
commenters requested, the definition of
direct care staff expressly excludes
housekeeping staff as well as any other
individuals whose services are
primarily related to maintaining the
physical environment of the long term
care facility. We believe this definition
clarifies how CMS intends to interpret
the scope of the reporting requirement.
We agree with commenters who
observed the reporting requirement
should be consistently interpreted from
the statute to the regulation to the
implementing guidance. We believe the
regulation is fully consistent with the
statute and we will revise our
subregulatory guidance to align with
provisions of this final regulation.
Finally, we note that we will take into
account commenters’ feedback on the
categories of direct care staff as we
refine the Draft PBJ Policy Manual.
(3) Hours Worked and Hours of Care
We proposed language for the new
§ 483.75(u)(1)(iii) that would require
facilities to submit information on staff
turnover and tenure and on the hours of
care provided by each category of staff
per resident per day (including, but
limited to start date, end date (as
applicable) and hours worked for each
individual.
We noted that section 1128I(g)(4) of
the Act requires LTC facilities to report
on the hours of care provided by each
category of certified employees per
resident per day. We expressed our
belief that the obligation to submit
information on ‘‘hours of care’’ is
satisfied by requiring facilities to submit
hours worked by staff. In addition, we
noted that although section 1128I(g)(2)
of the Act requires the submission of
resident case mix information, the
proposed rule did not include a
provision to implement this
requirement because existing
regulations at § 483.20 require LTC
facilities to meet this statutory
requirement through the required
submission of the Minimum Data Set
(MDS). Details of the comments we
received on submission requirements,
with our responses, appear below.
Comment: One commenter urged
CMS to be consistent with language in
the preamble and in the federal law
related to ‘‘hours worked’’ and to
eliminate language requiring the
reporting of hours of care provided.
Another commenter stated that they
believe that CMS must find a way to
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better capture hours provided than to
equate it to hours worked. This
commenter suggested one approach
might be to conduct time studies to
estimate the average amount of time
CNAs, LPNs and RNs spend on nondirect care tasks and subtract that time
from their total hours worked. Two
commenters stated that CMS should
require submission of time employees
are taking personal leave during the
work day (for example, for meals,
breaks), and stated that these should not
be recorded as hours worked as they are
not hours of care. They further stated
that although the language of CMS’s
proposed rule either quotes or
paraphrases the statutory language,
proposed at § 483.75(u), the preamble
suggests that ‘‘the obligation to submit
information on ‘hours of care’ is
satisfied by requiring facilities to submit
hours worked by staff.’’ (80 FR 22081).
Those commenters strongly disagree
with the approach to collect hours of
care worked as equivalent to hours of
care. They observed that there could be
a considerable difference between hours
of care actually provided and hours of
care worked. They stated that all staff,
as a matter of practice and by law, have
time when they are paid but are not
working—meal and other mandated
breaks, mandatory in-service training,
etc. They observed that in an eight-hour
workday, some time is devoted to meal
and other mandated breaks and
although staff may be paid for this time,
but they are not providing care to
residents. The commenters opined that
if CMS is unwilling to require facilities
to submit hours of direct care actually
provided, then it must delete at least
one hour from total hours worked in
order to reflect the time at work that is
not dedicated to resident care. Another
commenter stated that CMS should
require submission of time employees
are absent from the facility on workrelated leave if they are unavailable to
fulfill direct care responsibilities. The
commenter stated that this should
include time nurse aides spend
transporting individual residents to
medical appointments since they are
unavailable to provide services to other
residents during that time. Other
commenters expressed support for the
proposed reporting of hours worked, but
questioned how the reporting will
distinguish between direct care hours
worked and hours worked on
management and other responsibilities
by a salaried employee, as might be the
case for nurse managers who split their
time between direct care and
management functions. One commenter
remarked that they support the many
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job classifications for which the Draft
PBJ Policy Manual proposes to collect
staffing information, but for both
nursing and non-nursing job
classifications there needs to be more
specification on how to distinguish
hours of care versus mandatory breaks
or other non-direct care duties.
Other commenters supported the
reporting of hours worked, but stated
that submission specifications should
account for actual hours worked by
salaried/exempt staff. They observed
that exempt direct care employees can
frequently work more than the salaried
time period (for example, 40-hour basis)
for which they are paid. While alternate
compensation for any additional hours
will not be evident in a payroll-based
system, they suggested that the CMS
staffing data collection process should
account for this additional time to
accurately reflect direct care staffing and
coverage. Similarly, another commenter
observed that there are data elements
that are not captured in payroll data
alone, such as time worked off of the
clock for contract employees, or the
actual hours worked by the salaried
employee. The commenter stated that
capturing data that includes
productivity standards and time
allocated for indirect patient care would
further illuminate quality patient care
that is not intuitive to payroll data
alone. The commenter suggested that
this can be calculated by collecting data
for direct patient contact time, which is
captured in the MDS and/or medical
record. The commenter recommended
the inclusion of direct patient contact
time, as reported by speech language
pathologists or derived from the billable
minutes provided on the date of service.
Response: In our proposed approach,
and in this final regulation, we give
deference to the statutory requirement
that the staffing data be reported ‘‘based
on payroll and other verifiable and
auditable data in a uniform format
(according to specifications established
by the Secretary . . .).’’ Payrolls
represent the primary source of
verifiable and auditable information,
and are explicitly referenced in the
statute as such. Payroll systems contain
the key information organized as ‘‘hours
worked,’’ and provide the most effective
foundation for electronic reporting. We
have therefore maintained ‘‘hours
worked’’.
We appreciate commenters’
observation that payroll systems record
vacation, sick time, and certain other
absences that are time other than ‘‘hours
worked.’’ Therefore, when LTC facilities
report total hours worked by direct care
staff (based on payroll and other
verifiable and auditable data as
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specified by CMS), these data should
not include paid time off (for example,
vacation, sick leave, etc.).
At the same time, we recognize that
nursing home staff engage in other noncare and direct care activities
throughout their day, such as breaks.
Although outside the scope of this
rulemaking, we appreciate that in
calculating quality measures we may
need to adopt some statistical
refinements that allow for reasonable
estimates of such time in order to afford
the public the information that will
enable recognition of the time that staff
are engaged in non-care or non-direct
care activities. Also, as required in the
statute, we require that the primary care
area of each staff person (as well as each
individual’s hours) be reported. Such
categorization will allow the public to
identify which care areas are most
important to them, as well as to focus
on the types of staff who provide most
of the hands-on care. We thank the
commenters for identifying these issues,
and will take this feedback into account
when assessing future uses of the data,
such as quality measures.
We further note that the regulation
does not limit collection of information
to payroll data exclusively. In fact, the
regulation specifies that the information
will be ‘‘based on payroll and other
verifiable and auditable data’’ (emphasis
added). Although beyond the scope of
this rulemaking, we do not rule out the
possibility that future implementation
specifications could require submission
of information from time studies or
other methods, in addition to payroll
data, if CMS determines that other data
capture methods are auditable and
verifiable. For example, if at a future
date CMS concludes there are auditable
and verifiable data regarding extra hours
worked by salaried employees or hours
worked that are extraneous to the care
of residents, CMS may revise the
implementation specifications to
address the submission of these data
that permit refinement of the payroll
data. However, as indicated in the draft
subregulatory guidance implementing
this regulation, we anticipate that initial
reporting will be limited to the payrollreported data for each individual who
meets the definition of direct care staff.
We plan to continue to work with
stakeholders to further develop the
initial specifications to implement this
final rule and to make any future
refinements to this subregulatory
guidance.
Comment: A few commenters
recognized the value of collecting and
reporting staffing information but were
concerned about the administrative
burden resulting from this new
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reporting requirement, in particular for
hospital-based skilled-nursing facilities,
where many staff may work in both the
SNF and other departments of the
hospital and health system, and where
payroll systems are integrated. They
urged CMS to test the proposed data
collection system specifically in SNFs
operated as distinct parts of acute care
hospitals to address any unique issues
that might arise in that setting. Another
commenter observed that in their
facility, attached to a hospital, the
housekeeping, laundry, maintenance,
dietary, and administrative services are
provided by staff that conduct hospital
and nursing home services. The
commenter explained that at their
facility only the nursing time is directly
allocated to the nursing home on a
timesheet; the times worked in the other
departments are allocated to their
individual departments. The commenter
observed that at the end of the year
when the cost report is prepared, their
time is separated out to the revenue
producing departments (nursing home,
medical/surgical, ER, lab, radiology,
etc.) based on meals served, square
footage, pounds of laundry, etc. The
commenter stated that, currently, this
information will not be able to be sent
directly from their payroll system and
that it will be extremely time consuming
to figure out the percentage of time a
support service department employee
worked for the nursing home each day
and manually enter it into the PayrollBased Journal system. The commenter
observed that the cost report already
provides a summary of staffing salaries
and hours, and suggested that the cost
report could be modified to conform to
all the Affordable Care Act
requirements. Another commenter
stated that to require distinct part SNFs
to collect data on the services not
related to direct patient care, duties
which are shared with the institutions
where they are housed, will create
unnecessary administrative burden to
separate data for services, which are by
definition shared. This works against
the entire principle behind distinct part
SNFs, and is, in fact, impossible to
accomplish without hours of manual
labor. For example, the commenter
observed that in their 125-bed facility
they have a 38-bed ventilator assist unit,
with approximately 140 direct care staff
with a 10-hour per patient day ratio.
They stated that the amount of time to
submit staffing information on this unit
alone would require an inordinate
amount of resources. A hospital
association stated they are concerned
that the requirement will be
administratively burdensome,
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particularly in light of the challenges of
attributing hours worked to the distinct
part unit as opposed to the hospital
generally. They opined that therapy staff
hours are now kept by department and
allocated retrospectively as part of the
facility’s cost report. The association
stated that the payroll system for these
hospitals does not support the
automated submission of data as
envisioned in this regulatory proposal.
For these types of facilities, they
encouraged CMS to consider alternative
mechanisms—such as adaptions of the
current cost reporting system—to
demonstrate compliance with the
requirements of the statute. Finally, a
commenter stated that one of the issues
involved in reporting hours worked for
non-direct care staff involves SNFs that
are hospital or retirement community
based. The commenter stated that nondirect care staff provides services to the
whole organization and there is no way
to determine the number of hours
specific to the SNF and indicated that
Medicare cost report methodology
allows reporting of these ‘‘overhead’’
areas based on various statistics that
have no relationship to hours. The
commenter opined that to attempt to
determine the SNF related hours would
result in inaccurate estimates that
would not be meaningful and would be
a cumbersome manual process.
Response: We are aware that hospitalbased facilities and other facilities such
as nursing homes adjacent to assisted
living facilities or part of retirement
communities have staff that work in
multiple areas of the broader entity. In
response to these and other comments,
in this final rule we have added a
definition of ‘‘direct care staff’’ that
excludes certain facility support staff.
We believe that this adjustment will
help address a large portion of the staff
issues that distinct part and other
conjoined entities would otherwise face
with staff who have duties in multiple
entities. For the staff who do meet the
new definition of direct care staff,
facilities will still need to report the
hours that are allocated to the SNF/NF
residents only, and not include hours
for staff allocated for providing services
to residents in non-certified SNF/NF
beds. Data reported should be auditable
and able to be verified through either
payroll, invoices, and/or tied back to a
contract. Facilities must use a
reasonable methodology for calculating
and reporting the number of hours
allocated to providing services on site to
the SNF/NF residents, and exclude
hours allocated for providing services to
other individuals in other settings.
These types of facilities are encouraged
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to participate in the voluntary program
beginning on October 1, 2015. Voluntary
submission will allow facilities to work
through their processes to submit the
data in advance of the mandatory
submission period. We also note that
Medicare cost reports are not an
appropriate means to comply with this
staffing reporting requirement because,
among other concerns, they do not
contain all of the data needed to comply
with the Act, such as information on
turnover and tenure.
Comment: Several commenters
opined on how the submission schedule
should apply to resident census data.
Several commenters recommended that
CMS collect resident census data in a
time frame consistent with collection of
other staffing data under this
requirement. That is, they
recommended that if staffing data is
collected quarterly, census data should
be collected quarterly. Some
commenters suggested that data
regarding resident census should reflect
shorter time periods than quarterly. For
example, several commenters
recommended that the resident census
data submitted each quarter should
include three data points that reflect
each month’s total patient days in order
to accurately reflect the hours of direct
care per patient per day. Another
commenter urged CMS to require
facilities to collect and submit daily
resident census data to capture
fluctuations around facilities’ surveys
when many facilities temporarily
increase staff; to reflect reduced staffing
hours caused by higher absenteeism
during certain periods such as holidays;
and to reflect periods when census
unexpectedly increases, such as
accommodation of residents displaced
by a facility closure. Another
commenter remarked that it is their
understanding that based on the
specifications contained in the Draft PBJ
Policy Manual CMS intended to
interpret the proposed regulation to
require submission of census data based
on the resident population as of the last
date of each month of each quarter. The
commenter expressed strong objection
and concern with this approach as
misrepresentative and unreliable in
depicting the hours of direct care
provided per resident per day. The
commenter opined that that collection
of census information must be
compared to and consistent with the
data collected for hours worked during
the same submission period. The
commenter expressed the view that
calculation and use of the average daily
census for each month in a quarterly
submission period was strongly favored
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over the current CMS proposal. Another
commenter recommended that resident
census also be submitted on a daily
basis to capture fluctuations in staff-toresident ratios that may occur during a
30-day period that would not be
recorded if data were reported only on
the last day of the month; for example,
the period around the annual survey or
during a ban on admissions or closure.
One commenter stated that it is unclear
how the number of days will be
gathered from the submitted data for
purposes of determining hours of care
per resident day. Given the desired level
of accuracy in reporting of hours
worked, they advocated for an accurate
and unobtrusive method for collecting
information on the number of resident
days provided in each reporting period.
Finally, a commenter stated that CMS
proposes that resident census data
should be collected on the last day of
each of the 3 months within a quarter.
The commenter recommended staffing
data should be collected on a daily
basis, because the lack of daily resident
census data could lead to inaccurate
calculation of staffing levels, and
potential inflation of staffing level
averages. The commenter observed that
resident census fluctuates continually
throughout the month, and it would not
be a burden for facilities to report this
information since this information is
readily available at SNFs. They stated
that primary purpose of payroll-based
staffing data collection is to provide as
accurate as possible staffing level
information for consumers, rather than
the current system which is fairly
unreliable for several facilities as
facilities ‘‘staff-up’’ near their expected
inspection survey.
Response: We recognize that a
facility’s census fluctuates throughout
each month and appreciate suggestions
intended to promote the utility of the
census data submitted under this
regulation. However, while the
requirement to submit census
information is within the scope of this
rule, the specifications for this
submission are not. Therefore, these
comments will be taken into account as
we revise the Draft PBJ Policy Manual
and other subregulatory guidance. For
example, we will analyze the average
census of a facility based on the last day
of each month as compared to the
average census based on the daily
census. We will ensure that any
eventual quality measure will be
statistically sound in representing a
facility’s census. This may involve
altering the data we propose to collect
(for example, from once a month, to
daily) or collecting this information
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through other means. We note that the
method to submit census data described
in the current draft guidance was
recommended by stakeholders who
participated in the pilot in 2012 and
was structured to reduce provider
burden as much as possible.
Comment: Two commenters strongly
supported the submission of nurse
staffing hours by shift to capture what
they describe as the dangerous decline
that occurs in many facilities on the
afternoon and night shifts. They
expressed that sufficient direct care
nursing staff on one or two shifts
averaged over three shifts may hide
critically deficient nursing levels on the
other(s), when residents are at increased
risk of serious harm from missed care,
falls, abuse, elopement, missed meals,
and lack of assistance with toileting.
They further commented that shift-level
nurse staffing hours per resident day
would yield far more important
evidence of quality than minor
variations in case mix in typical nursing
homes. They also noted that the Staffing
Quality Measure (SQM) project
evaluated the feasibility of collecting
shift level data, concluding that it could
be done and would allow calculation of
‘‘more detailed staffing measures, such
as shift-level staffing ratios or the
proportion of shifts for which at least
one registered nurse was present.’’ One
commenter additionally remarked that
CMS should collect nurse staffing data
by unit. They concluded from the SQM
Final Report that researchers gave only
cursory attention to requiring facilities
to submit data by units. They asserted
that at a time when the industry is
creating special subacute care or rehab
units to maximize Medicare census and
reduce rehospitalization rates, adequate
or exceptional staffing in a subacute
unit can create a false picture of levels
in other units whose residents have
similar needs. They stated that without
such data, case mix adjustment would
be more likely to obscure staffing hours
than to clarify them. Another
commenter recommended that staffing
data be collected by shift and unit,
especially as more facilities are
developing Medicare/rehabilitation
units and subacute units.
Response: We agree that data
regarding staffing patterns at the shift
and/or unit level would be valuable
when assessing how LTC facilities are
administered; however, these
implementation specifications are
beyond the scope of this rulemaking.
We will continue to look at this as we
develop subregulatory guidance and
will evaluate the feasibility of collecting
these data elements in the future.
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Comment: One commenter
recommended that CMS reconsider
case-mix adjustment of staffing hours.
Another commenter expressed
opposition to making any adjustment for
case mix. The commenter suggested
that, at a minimum, the non-adjusted
staffing level data should be publicly
available. The commenter stated that the
case-mix of residents is changing
constantly, and consumers want to
know if facilities are truly staffing near
the recommended level of 4.1 hours per
resident day, or are they only near this
standard due to the case-mix
adjustment. One commenter strongly
objected to any language in regulations
that would require or imply that CMS
will use MDS data to adjust staffing
information that is reported on Nursing
Home Compare. In passing legislation to
replace inaccurate, self-reported staffing
data with information from auditable
payroll records, the commenter stated
that Congress intended to ensure that
the public has accurate information
about staffing hours, and that the
Congress did not intend to have
information from the new system
degraded by consolidation with data
from another self-reported source that is
frequently inaccurate and even
fraudulent. The commenter
acknowledged and welcomed the fact
that CMS is implementing nationwide,
focused MDS surveys in response to
criticism of the use of MDS data to
construct Quality Measures (that are
displayed on the CMS Nursing Home
Compare Web site), but noted that such
focused surveys will not be conducted
in all nursing homes, and that they will
be subject to the same limitations as
other surveys (such as surveyor
turnover, pressure from supervisors not
to cite deficiencies, and weak
enforcement).
Response: We thank commenters for
their suggestions but note that the use
of case-mix or MDS data is outside the
scope of this rule. We will work with
stakeholders prior to formulating
publicly posted quality measures. We
will consider making both adjusted and
unadjusted data available. However, we
believe that case mix adjustments are
important for the very reasons the
commenters observe—that the risk
profile of a nursing home’s resident
population does change over time, and
is also different from one facility to
another. We would expect that a nursing
home that has a population with a
higher risk profile should generally have
an overall higher staffing level, or a
staffing complement that matches the
risk profile (for example, higher RN
levels for a nursing home with a
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population that has a higher acuity level
compared to other nursing homes). We
appreciate that the MDS data have
limitations but at this time we believe
MDS reporting does meet the statutory
requirement for LTC facilities to submit
information on resident case-mix that
are auditable and verifiable. We will
also continue to monitor the results of
the new nationwide sample of targeted
MDS surveys to determine if additional
actions are advisable.
Comment: One commenter stated that
if the Congress’ intent was to ensure that
payroll data and staffing quality
measures would conform with the
minimum staffing requirements of the
Nursing Home Reform Law, which
require care to be provided by Licensed
Health Professionals and nurse aides
who meet the law’s 75-hour training,
competency evaluation, and registry
requirements, then they recommend
that CMS define ‘‘certified employees’’
as staff who are licensed health
professionals and/or who meet the
requirements for nurse aides, as defined
in section 1819(b)(5) of the Act.
Response: The requirement for
reporting staffing data is not limited to
licensed health care professionals and
nurse aides. Direct care staff includes
other staff that meet the definition of
direct care staff. That said, we will
provide definitions for certain categories
of staff, such as nurse aides, through
implementing guidance.
(4) Distinguishing Employees From
Agency and Contract Staff
Under section 1128I(g) of the Act’s
requirement that information for agency
and contract staff be kept separate from
information on employee staffing, we
proposed to add a new § 483.75(u)(2) to
establish that, when reporting direct
care staffing information for an
individual, a facility must specify
whether the individual is an employee
of the facility or is engaged by the
facility as contract or agency staff. We
believe the statute’s intent is to require
LTC facilities to submit staffing
information in a manner that can enable
us to distinguish those staff that are
employed by the facility from those that
are engaged by the facility under a
contract or through an agency. We do
not believe the statute requires such
data to be submitted at separate times or
through separate systems, which would
merely engender unnecessary costs and
burden, so we intend to collect all
facility staffing information at the same
time and through the same system,
employing a mechanism by which LTC
facilities will clearly specify whether
staff members are employees of the
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facility, or engaged under contract or
through an agency.
The comments we received on this
topic, with their responses, appear
below.
Comment: One commenter requested
that CMS further clarify in the Draft
Payroll-Based Journal Policy Manual
that ‘‘floaters’’ or other employees that
work at multiple facilities for the same
operator should be categorized as
contract staff. Another commenter
agreed that facilities must indicate
whether an employee is a direct
employee of the facility (exempt or nonexempt), or employed under contract
paid by the facility or through an
agency. The commenter stated that CMS
should consider defining ‘‘floaters’’—
individuals employed by the
corporation who may work for the same
employer but in different facilities at
different times—as agency employees.
Another commenter asked what the
applicable start and end dates would be
that a facility would report for contract
and agency staff, since these workers
can be used intermittently over
indeterminate time periods.
Response: We appreciate the
commenter’s insights into these
implementation issues. Although these
details are beyond the scope of this
regulation; we believe they are
appropriate for implementation
specifications. We will take these
comments into account when issuing
the revised Draft PBJ Policy Manual and
other subregulatory guidance.
(5) Data Format
We proposed to add a new
§ 483.75(u)(3) to establish that a facility
must submit direct care staffing
information in the format specified by
CMS. This provision would implement
the requirement in section 1128I(g) of
the Act that facilities submit direct care
staffing information in a uniform format.
As noted, we are consulting with
stakeholders on potential format
specifications. The data that we
proposed for submission are similar to
those already submitted by LTC
facilities to CMS on the forms CMS–671
and CMS–672 (we intended for this
proposed new information collection to
eventually supplant the data collections
via the CMS–671 and CMS–672). In
advance of the proposed July 1, 2016
implementation date, we will publicize
the established format specifications
and will offer training to help facilities
and other interested parties (for
example, payroll vendors) prepare to
meet the requirement.
The comments we received on this
topic, with their responses, appear
below.
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Comment: One commenter stated that
there should not be an unreasonable
financial burden placed on the
providers to report the information that
would be required, since providers are
already being negatively affected by the
sequestration and the managed care
plans. The commenter stated that even
though it is a good thing to keep costs
down for the federal budget and the
taxpayers, it is only the adjustment for
cost increases that has helped to
minimize the negative impact for the
providers. The commenter observed that
many providers have multiple types of
staff, which includes different types of
payment types from paychecks to
payables. The commenter explained that
this means that for many it is not one
combined system for all of the detail,
since not all of this information had
been required, so it will require either
a lot of hours to prepare or a lot of hours
to program or possibly both in order to
provide the information. The
commenter further stated that not all
providers benefited from the incentives
for moving to an electronic record.
Many were excluded from participation,
but had to bear the costs anyway due to
the sharing of patients (also called
residents, clients, etc.) and the
requirement to provide the information
electronically. The commenter opined
that this placed an undue hardship on
them. Another commenter remarked
that CMS has not adequately considered
and accounted for the costs to SNFs to
comply with the proposed data
collection. Several commenters
recommended that CMS complete a
regulatory analysis addressing these
costs. The commenters stated that the
interpretation of the legislation by CMS
through the proposed rule would be
overly burdensome, redundant, and
would create unnecessary and costly
expense to distinct part SNFs. They
asserted that the steps required to
supply the data outlined in the proposal
requires technical expertise, labor, and
payroll system vendors in order to meet
expectations. Another commenter
expressed concern regarding the time to
comply with this system proposed by
CMS. The commenter strongly
encouraged CMS to solicit input from a
broad variety of providers to develop an
approach that meets the requirements of
the Affordable Care Act and also is more
reasonable to providers in terms of labor
and cost. The commenter expressed
concern that cost of the requirements
would be obtained from the cost of
direct patient care given, as that
reimbursement would not likely be
increased. The commenter stated that, if
high costs were incurred, then it would
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be highly unlikely that additional data
requirements would have a positive
effect on the quality of nursing home
services but, instead, the potential to
decrease quality is significant as more
and more resources are directed to
regulatory mandates that do not affect
direct patient care. The commenter
stated that they were unaware of any
CMS research or data analysis that
demonstrates a direct relationship
between this level of data and quality
outcomes. Finally, the commenter stated
that required reporting of non-direct
patient care staffing data reduces the
ability to provide quality care, as
resources are diverted to administrative
reporting, away from direct patient care.
Another commenter opined that the
proposed rule and the inclusion of the
additional staffing data required by the
Draft PBJ Policy Manual extend beyond
the intent and language of the
Affordable Care Act and that this is an
unreasonable and costly additional
administrative burden which does not
improve patient care at a time when
delivering quality care at a reasonable
cost is paramount public policy; adding
undue hardship which does not
improve quality will have a definite
negative impact on care. One
commenter recommended that CMS
recognize that this new process is
occurring at the same time as several
other mandates that require significant
resource investment, including the
initiation of ICD–10 and the training
and software preparation needed. The
commenter identified other concurrent
provider efforts including initiation of
the collection of data for the Quality
Reporting Program related to the
IMPACT Act, the initiation of 30-day
all-cause, all-condition rehospitalization
reporting, ongoing transition to
electronic health records at many
facilities, and the initiation of
computerized physician order entry
(CPOE) at facilities and all while
providers work to increased
interoperability so that data can be
exchanged. One commenter supported
the electronic collection of staffing data
by CMS but noted that the system for
doing this should be reasonable and
achievable and as simple as possible.
Commenters were also concerned that
payroll vendors were not yet prepared
to accommodate the required reporting
and that providers would incur
compliance costs associated with
modifying their own payroll systems or
from vendors needing to make these
modifications. One commenter stated
that every employee will need to have
a unique employee number assigned for
tracking and reporting purposes that
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may require payroll and other systems
modifications. Another commenter
suggested CMS delay the mandatory
electronic submission of staffing data
until CMS has adequately tested the
submission system and determined the
cost and burden to providers to comply
with this proposed regulation. The
commenter observed that only the
volunteer facilities will have had an
opportunity to test the new system prior
to the mandatory report date of July 1,
2016 that applies to all facilities.
Response: We appreciate commenters
concerns about the costs associated with
submitting direct care staffing
information but note that this reporting
obligation mandated by section 1128I(g)
of the Act. We believe this final rule is
fully consistent with the intent and text
of the statute and represents the best
approach to minimize the burdens
associated with implementing the
statutory reporting requirement. Based
on the comments received, we have
included information on the estimated
costs and burden of this regulation to
facilities in section V. of this final rule.
As noted above, we will continue our
consultation with LTC facilities and
other stakeholders as we revised the
Draft PBJ Policy Manual and other
implementation guidance to implement
this regulation.
Comment: Several commenters
suggested that CMS modify alreadyexisting reports and/or reporting
systems to develop the uniform format
to be used for staff reporting submission
under this new regulation. Many
commenters suggested that their cost
reports could be modified to conform to
all the Affordable Care Act
requirements. One commenter stated
that CMS should consider using staffing
data that is collected for other programs
which could, with minor adjustments,
be used to meet the requirements of the
Affordable Care Act. The commenter
suggested that Medicare Cost Reports
collect similar data which is obtained
on a regular basis and a modified format
of this form would result in less burden
for providers and fewer opportunities
for discrepancies in information
provided in multiple reporting forms.
Two commenters stated that the
requirements of section 6106 of the
Affordable Care Act could be met,
consistent with the intent of the
Congress, through the existing resident
case-mix report without creating an
additional duplicative report. The
commenters stated that the report could
be expanded to include the other
requirements of the Affordable Care Act:
Aggregate nursing hours, number of
patient days, and staff turnover to be
reported quarterly. Another commenter
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suggested CMS work with states already
collecting this information to reduce the
reporting burden for facilities.
Response: In order to comply with
section 1128I(g) of the Act, the final rule
mandates that there be a uniform
national method of electronically
collecting specific staffing data that can
be applied for both Medicare SNFs and
Medicaid nursing facilities. When
implementing this regulation we will
adopt a system that will accommodate
this requirement. We do not agree that
the Medicare cost reports or existing
state-based systems will satisfy the
requirements of the law. For example,
Medicare cost reports do not contain the
data needed to comply with the Act,
such as information on turnover and
tenure.
Comment: One commenter suggested
in § 483.75(u)(3) after the heading
adding ‘‘uniform’’ before ‘‘format’’ for
consistency between the statutory and
regulatory text and for clarity in the
requirement for submission of data in a
uniform format.
Response: We agree. For consistency
purposes, we have added ‘‘uniform’’
before ‘‘format’’ in the text of
§ 483.75(u)(3)
(6) Effective Date for Submission
Requirement
In the proposed rule, we indicated
that the regulation would take effect on
July 1, 2016. We explained that prior to
this effective data, we would establish a
voluntary submission period whereby
facilities can submit staffing information
on a voluntary basis to become familiar
with the system and to provide feedback
to CMS on systems issues in advance of
the mandatory submission date.
Comment: We received several
comments regarding a phase-in or
postponement of the mandatory
submission date. One commenter
recommended calling for a wider-range
testing and evaluation period and/or
phase-in of the data collection system.
The commenter stated that this testing
period would not only allow a broader
spectrum of providers to gain
understanding and familiarity with the
process prior to final implementation,
but would add information regarding
cost and burden associated with
meeting the submission requirements.
For example, information could be
collected on the implementation of
required, but unanticipated system
modifications and the potential
investment of additional staff and/or
documentation time. Another
commenter suggested CMS phase in the
reporting process over time and to
initially only require reporting of the
nursing staff and to add other staff such
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as therapists at a later time. Another
commenter suggested that as part of
CMS’s consultation on the submission
specifications, they should include an
informal period of ‘‘testing’’ that will
allow all providers (not just those who
may volunteer for a ‘‘pilot’’) the
opportunity to work within the system
to determine how it interfaces with their
center’s system or to learn how to
confidently input the required data (for
those centers unable to automatically
upload their information). The
commenter suggested this proposal to
provide centers and CMS a clearer
understanding of the burden associated
with the submission requirements.
Another commenter stated that
contingent on the outcomes and/or
results of the voluntary submission
period, CMS should consider
postponement or a phase-in of the
intended July 1, 2016 mandatory
submission date pending resolution of
identified problems or glitches. The
commenter believes that all providers
should have the opportunity to test their
respective payroll and time and
attendance processes and gain
familiarity with the CMS submission
requirements. The commenter further
stated that CMS should again consider
a phase-in or ‘‘grace period’’ approach
within the planned mandatory reporting
implementation that includes deferral of
5-Star calculation and scoring for initial
submissions. The commenter concluded
that, at a minimum, given the limits of
the currently planned data collection
system trial, the allowance for postsubmission review and opportunity for
correction should continue for at least
the first year of mandatory
implementation.
Response: We are establishing a
voluntary submission period beginning
in October 2015. The voluntary
submission period will include a
phased approach to registration and
training which will allow facilities to
test their submission methods in
advance of the July 1, 2016 effective
date of the regulation. In order to meet
the requirements of section 6106 of the
Affordable Care Act as soon as possible,
we believe that July 1, 2016 is an
appropriate start date. However, we
appreciate that in any new, large system
of this nature, implementation
challenges may arise and adjustments
likely will need to be made in both the
receiving and sending systems.
Therefore, we do not plan to use the
results of the reported data in the CMS
Five Star Quality Rating System in CY
2016. During the implementation we
plan to maintain a feedback loop with
nursing homes regarding the data
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46469
submitted, issues identified, and
adjustments made or needed to the
implementation specifications. We also
plan to maintain use of the existing
CMS Form 671 annual paper-based form
during the initial implementation so
that the results of the traditional and the
new system can inform the learning
process.
(7) Submission Schedule
Section 1128I(g)(3) of the Act requires
that facilities submit direct care staffing
information on a regular reporting
schedule. At § 483.75(u)(4) we proposed
to establish that a facility must submit
direct care staffing information on the
schedule specified by CMS, but no less
frequently than quarterly. Comments we
received on this topic and our responses
appear elsewhere in this preamble.
(8) Compliance and Enforcement
In the proposed rule we noted that
§ 483.75(u) would establish that these
new reporting requirements would be
conditions a LTC facility must meet to
qualify to participate as a SNF in the
Medicare program or a NF in the
Medicaid program. As such, we
explained that we planned to enforce
the requirements under this new
regulation through 42 CFR part 488 and
non-compliance with the proposed
§ 483.75(u), could result in CMS or the
state imposing one or more remedies
available to address noncompliance
with the requirements for LTC facilities.
The comments we received on this
topic, with our responses, appear below.
Comments: One commenter proposed
that if a SNF is found to be noncompliant with the reporting
requirements, there should be an
expedited appeals process afforded to
the SNF prior to imposition of a civil
monetary fine or exclusion from a
federal healthcare program. Other
commenters stated that it would be
more fruitful to lay out specific
sanctions that CMS will impose if a
facility fails to comply with the new
reporting requirement. One commenter
suggested, for example, that if a facility
fails to provide required staffing data
within 30 days of the deadline, CMS
would send a warning letter; if the
facility did not provide the data within
20 days of the warning letter, CMS
would levy daily civil monetary
penalties of $X,000 per day starting on
the 21st day after the warning letter; if
the facility continued to fail to provide
staffing data at the 40th day following
the warning letter, CMS would institute
a hold on new admissions. The
commenter stated that such a
sanctioning approach would result in
more immediate compliance and clearer
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expectations for the providers. The
commenter further noted that if CMS or
the state determines that a facility has
intentionally provided inaccurate
staffing data, the non-compliance
should considered a material false claim
to the government for which payment is
sought and damages should be available
under the False Claims Act. The
commenters recommended internal
audits conducted by CMS, with noncompliance remedies of a significant
downgrading of Five Star Quality
Ratings while the facility is out of
compliance, a significant per day Civil
Monetary Penalty, and denial of
payment for new admissions until
compliance is achieved. Another
commenter noted that, given the
importance of this data, penalties
should be imposed when a provider
fails to submit staffing data as required
or submits inaccurate or false data. The
commenters recommended a per day
Civil Monetary Penalty at a significant
enough level to result in compliance.
The commenters further suggested, a
facility’s penalty should be posted
under ‘‘Staffing’’ on Nursing Home
Compare so it is easily visible to
consumers and others researching the
facility. Still another commenter stated
that they were concerned about the lack
of specificity with regard to remedies for
noncompliance and the potential for
flexibility, inconsistency, and lenience
that are unfortunately common in
enforcement of other requirements of
participation. The commenter noted that
the statement that CMS or the state may
impose one or more remedies
underscores our concern—sanctions
should be certain. Moreover, the
commenters believe the instructions are
ambiguous about when a deficiency and
remedy are triggered. Another
commenter urged CMS to provide
greater clarity about how compliance
with the proposed regulation will be
determined. One commenter suggested
that CMS clarify the possible
enforcement actions that may be
considered for aberrant data.
Response: We appreciate commenters’
interest in additional information
regarding how the agency will assess
compliance with this regulation and
what specific enforcement actions the
agency will pursue when it identifies
noncompliance. Discussion of
implementation specifications and how
the agency will apply its enforcement
are beyond the scope of this rulemaking.
We will take these comments into
account as we develop guidance at a
later date. We note, however, that
nothing in section 1128I(g) of the Act or
this final rule establishes that the staff
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reporting requirement is a condition of
payment.
Comment: One commenter opposed
the data collection requirement’s
inclusion as a requirement for
participation in Medicare, because the
timeline for implementation does not
afford all providers the opportunity to
test the CMS system and identify
problems that may occur when
interfacing with the facility’s software
and systems. Additionally, the
commenter noted that CMS has not
clearly stated within the proposed rule
how it will determine compliance with
the proposed regulation. Another
commenter urged CMS to eliminate the
staffing data collection designation as a
requirement of participation, since such
a designation will make compliance
subject to the full array of enforcement
actions. The commenter stated that it is
premature to make this collection a
requirement of participation since the
system for submission of the staffing
data is new and not adequately tested.
Response: As we stated in the
proposed rule, we believe that the
inclusion of the staffing data collection
as a requirement of participation is
appropriate and desirable, to meet the
legislative goal of greater accountability
for LTC facilities, given the importance
of staffing to the quality of care and
safety of the nursing home residents. We
further believe that the full array of
remedies available to enforce
compliance with other conditions of
participation should be available to
enforce this regulation and ensure that
the Act’s requirements are met. This
regulation is necessary to carry out
CMS’s and the state’s obligation to
ensure compliance with other
conditions of participation (COPs) as
specified in the Act. For example,
section 1819(b)(4) of the Act includes
requirements for staff such as nursing
services, pharmaceutical services,
dietary services and other services
facilities are required to provide, and
collection of the staffing data helps
verify compliance with these
requirements. However, we appreciate
there will be a learning curve as the new
reporting system is implemented. We
therefore plan to be careful when
assessing compliance to distinguish
between the effects of newness in the
initial implementation and failure to
implement the system and ensure
accuracy and adequacy of reporting.
Comment: One commenter remarked
that the proposed rule did not include
provisions for adjustment and/or
correction to submitted data. The
commenter noted that electronic staffing
data submission will serve to eliminate
current inconsistencies and mistakes
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common to manual completion of the
671 form, but cited examples of errors
were still possible under an automated
system. The commenter stated that
automated payroll systems frequently
‘‘lock down’’ once a payroll period ends
and have to be re-entered manually for
changes or updates. The commenter
further stated that there can also be
occasional clock breakdowns or
clocking oversights, for example, if an
individual clocks out, is asked to stay,
but fails to clock back in, all hours
worked may not be captured in real
time. The commenter explained that
similarly, some providers have adopted
universal worker practices, with those
employees performing, for example,
non-nursing or other functions at
different points, again resulting in
potential clocking oversights or
omissions. The commenter stated that in
any of these circumstances, hours
worked would at least initially be
documented somewhere other than the
payroll system and, if identified after a
payroll period has closed and/or data
transmission to CMS, adjustment would
be required to accurately reflect staffing
and coverage. The commenter believes a
defined process should be incorporated
into the collection and reporting system
to allow providers to make documented,
verifiable, and auditable data-based
adjustments/corrections to submitted
staffing information. The commenter
stated that these adjustments/
corrections should be permitted within
the respective quarter to assure accurate
documentation and calculation of staff
hours worked and direct care services
provided.
Response: We appreciate the
commenter’s observations about areas of
ongoing data vulnerability and
providers’ interest in making corrections
when they identify errors with
previously submitted data. We
anticipate that our reporting system
when fully implemented will include
functionality to submit data corrections.
We will address this issue in further
detail through guidance.
(9) Other Comments
Comment: Several commenters
requested that CMS provide a written
report on the results of the 2012 Staffing
Data Collection Pilot to providers in
advance of finalizing this rule. The
commenters stated that CMS references
the 6-month staffing data collection
pilot conducted in 2012 as a strategy
component in engaging in ongoing
consultation with all relevant parties
and stakeholders; however, no report
regarding the results and outcomes of
this pilot has ever been released for
review and feedback by these entities.
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The commenters believe that knowledge
of the challenges and successes that
were determined based on this pilot
would be very beneficial in terms of
‘‘lessons learned’’, enabling greater
understanding of the requirements being
proposed and final implementation of
the currently drafted ‘‘Electronic
Staffing Data submission Payroll-based
Journal’’ (PBJ) system.
Response: As part of our on-going
consultation with stakeholders, we will
make information from this project
available on the CMS Staffing Data
Submission Web site at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
Staffing-Data-Submission-PBJ.html.
However, it is important to note that
this information relates to the
implementation specifications, not the
regulatory requirement, and therefore
CMS is proceeding with finalization of
the rule at this time but hopes the data
from the project will facilitate dialogue
as the agency develops implementation
guidance.
Comment: One commenter stated that
further clarification is needed regarding
the voluntary submission process
referenced in the preamble of the
proposed rule to be conducted
beginning in October 2015. The
commenter stated that it is not clear
whether these submissions will be
instead of, or in addition to, the CMS
671 form, and or whether the
information collected during this period
will be data of record, thereby subject to
5-Star Nursing Home Rating System
calculations and potential remedies if
noncompliance is determined. The
commenter stated that modifications
will have to be made to virtually all
homes’ payroll and time and attendance
processes to accommodate the
provisions of this rule, and not all
homes will be able to begin submission
during the voluntary period to test their
own systems against the CMS data
collection process. The commenter
noted that again, with the variation in
current payroll and time and attendance
systems in nursing homes, providers
must have some margin and flexibility
to allow for unanticipated interfacerelated problems and need for further
modifications that may occur with the
junction of the PBJ and their respective
processes. The commenter stated that
the voluntary period will be the first
wide-range, and to their understanding,
the only testing opportunity for the CMS
staffing data collection process. The
commenter stated that the goal should
be true evaluation and assessment, with
the participating nursing homes not
subject to Five-Star scoring or survey
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and enforcement actions based only on
these initial preliminary submissions.
The commenter stated that if voluntary
submissions are to be considered data of
record, at minimum there should be an
accompanying allowance for post
submission review as needed, with
opportunity to rectify identified errors,
misinterpretations, or omissions prior to
final determinations.
Response: As stated in the preamble
of the proposed rule, we intend to
eventually supplant the form CMS–671
and CMS–672, however, facilities will
still be required to complete these until
further notice. Data submitted through
the PBJ system during the voluntary
submission period will not have any
impact on a facility’s Five-Star rating, or
result in any enforcement remedies.
Facilities will be provided with
information about their voluntary
submissions so they can make
adjustments and be better prepared for
the mandatory submission period. We
do not plan on using the results of the
reported data in the Five-Star Quality
Rating System calculations in either CY
2015 or CY 2016 in order to
accommodate both the voluntary phase
and the initial months of mandatory
reporting.
Comment: Several commenters
expressed that manually uploaded data
should not be permitted on an ongoing
basis. The commenters noted that CMS
should require facilities that want to
submit some or all data manually to
request a waiver documenting that they
do not have the capability to report
using an automated payroll system. The
commenter stated that CMS should
establish a deadline for facilities to have
fully automated data reporting ability to
meet the requirements of the law, after
which manual submission would be
noncompliant. The commenter
recommended that waiver requests
should be time-limited and require an
annual re-application process in which
the provider must document the steps
taken to automate its system. Another
commenter stated that CMS must ensure
that staffing data come from verifiable,
auditable sources and not self-reporting
by facilities.
Response: The requirement in this
regulation is for facilities to submit the
data electronically, which facilities will
do through the system we will provide.
We note that regardless of whether a
facility uploads their data from a payroll
system, or enters it manually, all
facilities are held to the same reporting
requirements and standards.
Comment: One commenter remarked
that data should be collected in an allinclusive and meticulous manner that
represents the complete assessment of
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care furnished in the SNF setting. The
commenter strongly urged CMS to
adhere to the following: (1) Only count
staffing data that represent a complete
episode of care from admission to
discharge; (2) CMS should distinguish
those cases in which an unexpected
readmission or inpatient hospital stay
occurred; and (3) provide feedback
reports to all applicable facilities prior
to public reporting and provide an
appropriate timeframe for facilities to
dispute any information they believe is
inaccurate. Another commenter
requested that CMS clarify how the data
will be analyzed, the benchmark that
will be used to define quality, and the
additional uses or actions CMS
anticipates as a result of collecting this
data.
Response: We are not entirely clear on
some of the commenter’s suggestions
and note that some issues raised by this
commenter are outside of the scope of
this rulemaking. The data collected
under this regulation will not count
episodes of care, but will reflect the staff
in the facility and related average
census. Although outside the scope of
this rulemaking, we plan to provide
feedback reports to providers and allow
facilities to dispute information they
believe to be inaccurate. In addition, we
plan to discuss the uses of the data,
including quality measures, with
stakeholders prior to public posting.
Comment: One commenter requested
that we eliminate the part-time/full-time
distinction that appears in the Draft PBJ
Policy Manual. The commenter stated
that organizations vary in their
definitions of part-time and full- time.
The commenter believes in collecting
staff hours worked for the purpose of
interpreting staffing levels based on
payroll and related auditable and
verifiable data, it is irrelevant whether
coverage is being provided by full or
part-time employees.
Response: While this comment is
directed at an issue outside the scope of
this regulation, we agree. In response to
feedback received, we have eliminated
the part-time/full-time distinction
described in the Draft PBJ Policy
Manual.
Comment: One commenter requests
that base hourly wage information be
collected as part of this process, which
can used to develop a SNF-specific
wage index.
Response: We believe this request is
outside of the scope of the rulemaking.
Further, we do not believe that section
1128I(g) of the Act authorizes us to
require the reporting of base hourly
wages.
Comment: One commenter stated that
in light of the importance of MDS
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assessment accuracy for QM reporting,
payment, and coordination of the
resident care plan across the care
continuum, we recommend that duties
related to completion of the RAI be
separated out in statistical reporting job
category (RN, LPN, etc.). Licensed staff
performing RAI work cannot be
accurately identified in the current
proposed structure. The commenter
stated that it is very important that the
nurse staffing data enable consumers
and researchers to know who is actually
conducting the RAI. The commenter
noted that while the LVN/LPN is
authorized to perform the RAI process
and certify its accuracy, an RN is
required to coordinate the RAI process
and verify completion (F–278,
§ 483.20(h), Coordination: A registered
nurse must conduct or coordinate each
assessment with the appropriate
participation of health professionals).
Response: This request relates to the
implementation specifications and is
beyond the scope of this rulemaking. As
we develop subregulatory guidance, we
will work with stakeholders to consider
any additional types of staff that should
be reported separately, including RAI or
MDS Coordinators.
Comment: One commenter strongly
recommended against conducting audits
for compliance with this staffing
reporting requirement as part of the
survey process, either as regular or
focused surveys.
Response: The operations of audits
are outside the scope of this regulation.
As a general matter, CMS seeks to
ensure that the audits to assess
compliance with reporting requirements
are conducted in a manner that directly
addresses the need to verify the data
submitted by facilities. This includes
having the audits conducted by
individuals or entities who are subject
matter experts in this area.
Comment: One commenter remarked
that it is not clear when the payroll
submissions are due (for example, how
much time providers will be given after
the end of the quarter to make their
submission).
Response: We will communicate
information on submission
requirements through guidance. For
example, the Draft PBJ Policy Manual
states that providers have 45 days from
the end of the quarter to submit their
data. Please see the following Web site
for more information: https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
Staffing-Data-Submission-PBJ.html.
Comment: One commenter stated that
reports must include the number and
types of nursing staff on each shift,
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including mutually exclusive staff
categories, in particular RNs versus
LPNs. For example, in reporting staffing,
LPNs with administrative duties are not
to be combined with RNs with
administrative duties.
Response: The reporting of data is
outside the scope of this regulation. We
will work with stakeholders prior to
posting information or formulating
quality measures.
Comment: One commenter cautioned
that if a facility has low staffing levels,
it would not necessarily equate to poor
quality of care.
Response: While this comment is
discussing proposed uses of the
collected data which is outside the
scope of this regulation, we agree that
there are many factors that contribute to
good quality of care. Families and
residents should not only use a variety
of information in making judgments
about a facility (such as the various
types of information available on the
CMS Nursing Home Compare Web site),
but above all should visit facilities, talk
to residents and staff, and consult with
other knowledgeable parties in the
community (such as the State Survey
Agency and the local Nursing Home
Ombudsman Program).
Comment: Several commenters
expressed support for the
implementation of this rule and CMS’
intent to ensure that accurate staffing
data was being reported by LTC
facilities.
Response: We thank these
commenters for their support.
c. Provisions of the Final Rule
We are adopting the provisions of this
final rule as proposed, with the
following changes:
• In consideration of public
comments, we added a definition of
‘‘direct care staff’’ at § 483.75(u)(1). We
renumbered the subsections within
§ 483.75(u) accordingly. In addition, we
made conforming changes to utilize the
defined term in the provisions regarding
the submission requirements at
§ 483.75(u)(2)(i) and (iii) in the final rule
and the provision regarding
distinguishing employee from agency
and contract staff at § 483.75(u)(3) of
this final rule.
• Finally, in consideration of public
comment, we added the adjective
‘‘uniform’’ to describe the format
requirement in the provision regarding
data format in § 483.75(u)(4) of the final
rule.
IV. Collection of Information
Requirements
In the FY 2016 SNF PPS proposed
rule (80 FR 22082), we solicited public
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comment on that rule’s information
collection requirements as they relate to
the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501 et seq.). However,
of all of the comments received on the
proposed rule, only one was related to
our position that all of the proposed
information collection requirements
were exempt from the PRA. A summary
of the comment and our response
follows.
Consistent with the proposed rule,
this final rule maintains that the
information collection requirements are
exempt from the PRA. We refer readers
to the FY 2016 SNF PPS proposed rule
for details.
Comment: One commenter disagreed
with CMS’s assertion that the PRA does
not apply to the proposed staff reporting
requirements. The commenter further
stated that because the Affordable Care
Act, not OBRA 1987, was the statute
that established the staff reporting
requirements, the requirements would
likely not fall within the scope of OBRA
1987’s PRA waivers.
Response: We respectfully disagree
with the commenter’s analysis. The staff
reporting requirements are exempt from
PRA because section 6106 of the
Affordable Care Act (which added
1128I(g) of the Act) is related to the
information required for the purposes of
carrying out relevant sections of OBRA
1987’s nursing home reform
requirements. For example, section
1819(b)(4) of the Act includes
requirements for staff such as nursing
services, pharmaceutical services,
dietary services, and other services
facilities are required to provide, and
the collection of the staffing data helps
verify compliance with these
requirements.
V. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
We have examined the impacts of this
final 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), and the Congressional
Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
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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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2. Statement of Need
This final rule would update the SNF
prospective payment rates for FY 2015
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
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. In
addition, this final rule specifies a SNF
all-cause all-condition hospital
readmission measure, as well as adopts
that measure for a new SNF VBP
Program, and includes a discussion of
SNF VBP Program policies we are
considering for future rulemaking to
promote higher quality and more
efficient health care for Medicare
beneficiaries. This final rule also
implements a new quality reporting
program for SNFs, as specified in the
IMPACT Act. Finally, through this final
rule, we are implementing section
1128I(g) of the Act, which requires the
electronic submission of staffing
information based on payroll and other
verifiable and auditable data.
3. Overall Impacts
This final rule sets forth updates of
the SNF PPS rates contained in the SNF
PPS final rule for FY 2015 (79 FR
45628). Based on the above, we estimate
that the aggregate impact would be an
increase of $430 million in payments to
SNFs, resulting from the SNF market
basket update to the payment rates, as
adjusted by the applicable forecast error
adjustment and by the MFP adjustment.
The impact analysis of this final rule
represents the projected effects of the
changes in the SNF PPS from FY 2015
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to FY 2016. Although the best data
available are utilized, there is no
attempt to predict behavioral responses
to these changes, or to make
adjustments for future changes in such
variables as days or case-mix.
Certain events may occur to limit the
scope or accuracy of our impact
analysis, as this analysis is futureoriented and, thus, very susceptible to
forecasting errors due to certain events
that may occur within the assessed
impact time period. Some examples of
possible events may include newlylegislated general Medicare program
funding changes by the Congress, or
changes specifically related to SNFs. In
addition, changes to the Medicare
program may continue to be made as a
result of previously-enacted legislation,
or new statutory provisions. Although
these changes may not be specific to the
SNF PPS, the nature of the Medicare
program is such that the changes may
interact and, thus, the complexity of the
interaction of these changes could make
it difficult to predict accurately the full
scope of the impact upon SNFs.
In accordance with sections
1888(e)(4)(E) and 1888(e)(5) of the Act,
we update the FY 2015 payment rates
by a factor equal to the market basket
index percentage change adjusted by the
FY 2014 forecast error and the MFP
adjustment to determine the payment
rates for FY 2016. As discussed
previously, for FY 2012 and each
subsequent FY, as required by section
1888(e)(5)(B) of the Act as amended by
section 3401(b) of the Affordable Care
Act, the market basket percentage is
reduced by the MFP adjustment. The
special AIDS add-on established by
section 511 of the MMA remains in
effect until such date as the Secretary
certifies that there is an appropriate
adjustment in the case mix. We have not
provided a separate impact analysis for
the MMA provision. Our latest estimates
indicate that there are fewer than 4,800
beneficiaries who qualify for the add-on
payment for residents with AIDS. The
impact to Medicare is included in the
total column of Table 12. In updating
the SNF PPS rates for FY 2016, we made
a number of standard annual revisions
and clarifications mentioned elsewhere
in this final 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
final rule applies to SNF PPS payments
in FY 2016. Accordingly, the analysis
that follows only describes the impact of
this single year. In accordance with the
requirements of the Act, we will publish
a notice or rule for each subsequent FY
that will provide for an update to the
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46473
SNF PPS payment rates and include an
associated impact analysis.
In accordance with sections 1888(g)
and (h)(2)(A) of the Act, we are
finalizing the adoption of a SNF 30-Day
All-Cause Readmission Measure
(SNFRM) for the SNF VBP Program.
Because this measure is claims-based,
its adoption under the SNF VBP
Program would not result in any
increased costs to SNFs.
However, we do not yet have
preliminary data with which we could
project economic impacts associated
with the measure. We intend to make
additional proposals for the SNF VBP
Program in future rulemaking, and we
will assess the impacts of the SNFRM
and any associated SNF VBP Program
proposals at that time.
The burden associated with the SNF
QRP is the time and effort associated
with data collection and reporting. In
this final rule, we are finalizing three
quality measures that meet the
requirements of section 1888(e)(6)(B)(II)
of the Act.
Our burden calculations take into
account all ‘‘new’’ items required on the
MDS 3.0 to support data collection and
reporting for these three finalized
measures. New items will be included
on the following assessments: SNF PPS
5-Day, Swing Bed PPS 5-Day, OMRA—
Start of Therapy Discharge, OMRA—
Other Discharge, OBRA Discharge,
Swing Bed OMRA—Start of Therapy
Discharge, Swing Bed OMRA—Other
Discharge, and Swing Bed Discharge on
the MDS 3.0. The SNF QRP also
requires the addition of a SNF PPS Part
A Discharge Assessment, which will
also include new items. New items
include data elements required to
identify whether pressure ulcers were
present on admission, to inform future
development of the Percent of Residents
or Patients with Pressure Ulcers That
Are New or Worsened (Short Stay) (NQF
#0678), as well as changes in function
and occurrence of falls with major
injury. To the extent applicable, we will
use standardized items to collect data
for the three measures. For a copy of the
data collection instrument, please visit:
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
SNF-Quality-Reporting-ProgramMeasures-and-TechnicalInformation.html.
We estimate a total additional burden
of $30.00 per Medicare-covered SNF
stay, based on the most recent data
available, in this case FY 2014, that
15,421 SNFs had a total of 2,599,656
Medicare-covered stays for fee-forservice beneficiaries. This would equate
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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
to 1,112,002.85 total added hours or
72.11 hours per SNF annually.
We anticipate that the additional MDS
items we finalized will be completed by
Registered Nurses (RN), Occupational
Therapists (OT), and/or Physical
Therapists (PT), depending on the item.
We identified the staff type per item
based on past LTCH and IRF burden
calculations in conjunction with expert
opinion. Our assumptions for staff type
were based on the categories generally
necessary to perform assessment:
Registered Nurse (RN), Occupational
Therapy (OT), and Physical Therapy
(PT). Individual providers determine the
staffing resources necessary, therefore,
we averaged the national average for
these labor types and established a
composite cost estimate. We obtained
mean hourly wages for these staff from
the U.S. Bureau of Labor Statistics’ May
2013 National Occupational
Employment and Wage Estimates
(https://www.bls.gov/oes/current/oes_
nat.htm), and to account for overhead
and fringe benefits, we have doubled the
mean hourly wage. The mean hourly
wage for an RN is $33.13, doubled to
$66.26 to account for overhead and
fringe benefits. The mean hourly wage
for an OT is $37.45, doubled to $74.90
to account for overhead and fringe
benefits. The mean hourly wage for a PT
is $39.51, doubled to $79.02 to account
for overhead and fringe benefits.
To calculate the added burden, we
first identified the total number of new
items to be added into assessment
instruments. We assume that each new
item accounts for 0.5 minutes of nursing
facility staff time. This assumption is
consistent with burden calculations in
past IRF and LTCH federal regulations.
For each staff type, we then multiply the
added burden in minutes with the
number of times we believe that each
item will be completed annually. To
identify the number of times an item
would be completed annually, we noted
the number of total SNF FFS Medicarecovered stays in FY 2014, the most
recent data available to us. We assume
that if an item were added to all
discharge assessments, then that item
would be completed at least one time
per SNF FFS Medicare-covered stay. For
example, the time it takes to complete
an item added to all discharge
assessments (0.5 minutes) would be
multiplied by the number of SNF FFS
Medicare-covered stays in FY 2014 to
identify the total added burden in
minutes associated with that item. Items
added only to the SNF PPS Part A
Discharge were weighted to reflect the
proportion of SNF stays for residents
who switch payers, but are not
physically discharged from the facility.
Added burden in minutes per staff type
was then converted to hours and
multiplied by the doubled hourly wage
to identify the annual cost per staff type.
Given these wages and time estimates,
the total cost related to the SNF PPS
Part A Discharge Assessment and SNF
QRP measures is estimated at $5,057.45
per SNF annually, or $78,011,166.25 for
all SNFs annually. We received
comments regarding the burden related
to the SNF QRP, which we addressed in
section III.D.3.g.(2). of this final rule.
We have also conducted an impact
analysis with regard to the electronic
submission of staffing information,
which will be required under 42 CFR
483.75(u). While facilities have been
reporting their staffing data for many
years via an annual, paper-based
system, we appreciate that the
electronic submission of staffing data is
something that facilities have not been
required to do and that this new
requirement will have financial and/or
staff time implications. Like the
implementation of many new programs,
the level of effort will be higher upfront,
but decline throughout subsequent
years.
4. Detailed Economic Analysis
The FY 2016 SNF PPS payment
impacts appear in Table 12. Using the
most recently available data, in this case
FY 2014, we apply the current FY 2015
wage index and labor-related share
value to the number of payment days to
simulate FY 2015 payments. Then,
using the same FY 2014 data, we apply
the FY 2016 wage index and laborrelated share value to simulate FY 2016
payments. We tabulate the resulting
payments according to the
classifications in Table 12 (for example,
facility type, geographic region, facility
ownership), and compare the simulated
FY 2015 payments to the simulated FY
2016 payments to determine the overall
impact. The breakdown of the various
categories of data in the table 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 hospitalbased, 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 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 zero
percent; however, there are
distributional effects of the change.
The fourth column shows the effect of
all of the changes on the FY 2016
payments. The update of 1.2 percent
(consisting of the market basket increase
of 2.3 percentage points, reduced by the
0.6 percentage point forecast error
adjustment and further reduced by the
0.5 percentage point MFP adjustment) 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 1.2
percent, assuming facilities do not
change their care delivery and billing
practices in response.
As illustrated in Table 12, the
combined effects of all of the changes
vary by specific types of providers and
by location. For example, due to
changes finalized in this rule, providers
in the rural Pacific region would
experience a 1.4 percent increase in FY
2016 total payments.
TABLE 12—PROJECTED IMPACT TO THE SNF PPS FOR FY 2016
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Number of
facilities
FY 2016
Group:
Total ......................................................................................................................................
Urban ....................................................................................................................................
Rural .....................................................................................................................................
Hospital based urban ...........................................................................................................
Freestanding urban ..............................................................................................................
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15,425
10,888
4,537
546
10,342
E:\FR\FM\04AUR2.SGM
04AUR2
Update wage
data
(%)
0.0
0.1
¥0.6
0.2
0.1
Total change
(%)
1.2
1.3
0.6
1.4
1.3
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
46475
TABLE 12—PROJECTED IMPACT TO THE SNF PPS FOR FY 2016—Continued
Number of
facilities
FY 2016
Hospital based rural .............................................................................................................
Freestanding rural ................................................................................................................
Urban by region:
New England ........................................................................................................................
Middle Atlantic ......................................................................................................................
South Atlantic .......................................................................................................................
East North Central ................................................................................................................
East South Central ...............................................................................................................
West North Central ...............................................................................................................
West South Central ..............................................................................................................
Mountain ...............................................................................................................................
Pacific ...................................................................................................................................
Outlying .................................................................................................................................
Rural by region:
New England ........................................................................................................................
Middle Atlantic ......................................................................................................................
South Atlantic .......................................................................................................................
East North Central ................................................................................................................
East South Central ...............................................................................................................
West North Central ...............................................................................................................
West South Central ..............................................................................................................
Mountain ...............................................................................................................................
Pacific ...................................................................................................................................
Ownership:
Government ..........................................................................................................................
Profit .....................................................................................................................................
Non-profit ..............................................................................................................................
Update wage
data
(%)
Total change
(%)
627
3,910
¥0.6
¥0.6
0.6
0.6
801
1,485
1,853
2,068
544
899
1,310
501
1,420
7
0.5
0.6
¥0.2
¥0.1
0.0
¥0.5
¥0.1
¥0.4
0.6
¥1.1
1.7
1.8
1.0
1.1
1.2
0.6
1.1
0.8
1.8
0.1
142
222
511
937
535
1,089
765
233
103
¥0.9
¥1.4
¥0.1
¥0.1
¥0.5
¥0.9
¥1.3
¥0.8
0.2
0.3
¥0.3
1.1
1.1
0.7
0.3
¥0.1
0.4
1.4
882
10,862
3,681
0.0
0.0
¥0.1
1.2
1.2
1.1
tkelley on DSK3SPTVN1PROD with RULES2
Note: The Total column includes the 2.3 percent market basket increase, reduced by the 0.6 percentage point forecast error adjustment and
further reduced by the 0.5 percentage point MFP adjustment. Additionally, we found no SNFs in rural outlying areas.
We have also conducted an economic
analysis with regard impact of the
electronic submission of staffing
information, which is required under 42
CFR 483.75(u). Factors affecting a
facility’s cost include the size of the
facility, the number of employees of a
facility, and the type of system a facility
uses to report and submit data. To
calculate the cost, we analyzed
information from a staffing pilot
conducted in 2012, including evaluating
the type (for example, hours per day)
and frequency (for example, quarterly)
of the information to be submitted. For
example, we estimate that a facility
using a complex, automated payroll or
time-keeping system would require
some upfront and ongoing costs to
configure their system to provide the
data. We estimate these costs to be
approximately $500 to $1,500 upfront,
with an additional $500 to $1,500 in
maintenance costs each year.
Additionally, we estimate this type of
facility would require an estimated 1
hour of in-house staff time per week, to
oversee the process. Conversely, a
facility without an automated timekeeping system would not have the
upfront and ongoing costs associated
with purchasing or configuring a
system. However, this facility would
require more time from in-house staff to
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enter and submit the data. We estimate
this time to be approximately 4 hours
per week. To help mitigate potential
cost for facilities, we will be providing
a system for facilities to enter and
submit data manually and at no cost.
Using the 2013 hourly wage estimate of
$18.71 per hour for payroll and
timekeeping employees in Skilled
Nursing Facilities from the Bureau of
Labor Statistics, we believe that the cost
to facilities will range between $4,100
and $6,800 per facility for the first year
of implementation. This includes onetime costs associated with configuring
payroll or time-keeping systems to
produce and submit the required data.
Subsequent years would have lower
costs ranging from $2,700 to $4,200 per
facility per year. These estimates also
include up to 16 hours per year for
training staff on the submission of data.
5. Alternatives Considered
As described in this section, we
estimate that the aggregate impact for
FY 2016 would be an increase of $430
million in payments to SNFs, resulting
from the SNF market basket update to
the payment rates, as adjusted by the
applicable forecast error adjustment and
by the MFP adjustment.
Section 1888(e) of the Act establishes
the SNF PPS for the payment of
Medicare SNF services for cost reporting
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periods beginning on or after July 1,
1998. This section of the statute
prescribes a detailed formula for
calculating 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 the payment
methodology as discussed previously.
Section 1128I(g) of the Act establishes
requirement for LTC facilities to submit
direct care staffing information. This
section of the statute specifically
prescribes the data to be submitted.
Accordingly we are not pursuing
alternatives to the reporting requirement
as discussed previously.
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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
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, we estimate
approximately 91 percent of SNFs are
considered small businesses 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 Web
site at https://www.sba.gov/category/
navigation-structure/contracting/
TABLE 13—ACCOUNTING STATEMENT: contracting-officials/eligibility-sizeCLASSIFICATION OF ESTIMATED EX- standards). In addition, approximately
25 percent of SNFs classified as small
PENDITURES, FROM THE 2015 SNF
entities are non-profit organizations.
PPS FY TO THE 2016 SNF PPS Finally, individuals and states are not
FY
included in the definition of a small
entity.
Category
Transfers
This final rule sets forth updates of
the SNF PPS rates contained in the SNF
Annualized Monetized $430 million. *
PPS final rule for FY 2015 (79 FR
Transfers.
45628). Based on the above, we estimate
From Whom To
Federal Government
that the aggregate impact would be an
Whom?
to SNF Medicare
increase of $430 million in payments to
Providers.
SNFs, resulting from the SNF market
* The net increase of $430 million in transfer
payments is a result of the forecast error and basket update to the payment rates, as
MFP adjusted market basket increase of $430 adjusted by the MFP adjustment and
million.
forecast error adjustment. While it is
projected in Table 12 that most
7. Conclusion
providers would experience a net
This final rule sets forth updates of
increase in payments, we note that some
the SNF PPS rates contained in the SNF individual providers within the same
PPS final rule for FY 2015 (79 FR
region or group may experience
45628). Based on the above, we estimate different impacts on payments than
the overall estimated payments for SNFs others due to the distributional impact
in FY 2016 are projected to increase by
of the FY 2016 wage indexes and the
$430 million, or 1.2 percent, compared
degree of Medicare utilization.
with those in FY 2015. We estimate that
Guidance issued by the Department of
in FY 2016 under RUG–IV, SNFs in
Health and Human Services on the
urban and rural areas would experience, proper assessment of the impact on
on average, a 1.3 and 0.6 percent
small entities in rulemakings, utilizes a
increase, respectively, in estimated
cost or revenue impact of 3 to 5 percent
payments compared with FY 2015.
as a significance threshold under the
RFA. According to MedPAC, Medicare
Providers in the urban Pacific and
covers approximately 12 percent of total
Middle Atlantic regions would
patient days in freestanding facilities
experience the largest estimated
and 22 percent of facility revenue
increase in payments of approximately
(Report to the Congress: Medicare
1.8 percent. Providers in the rural
Payment Policy, March 2015, available
Middle Atlantic region would
at https://medpac.gov/documents/
experience a small decrease in
reports/chapter-8-skilled-nursingpayments of 0.3 percent.
facility-services-(march-2015B. Regulatory Flexibility Act Analysis
report).pdf). However, it is worth noting
The RFA requires agencies to analyze that the distribution of days and
options for regulatory relief of small
payments is highly variable. That is, the
entities, if a rule has a significant impact majority of SNFs have significantly
on a substantial number of small
lower Medicare utilization (Report to
entities. For purposes of the RFA, small the Congress: Medicare Payment Policy,
entities include small businesses, nonMarch 2015, available at https://
profit organizations, and small
medpac.gov/documents/reports/
governmental jurisdictions. Most SNFs
chapter-8-skilled-nursing-facilityand most other providers and suppliers
services-(march-2015-report).pdf). As a
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6. Accounting Statement
As required by OMB Circular A–4
(available online at
www.whitehouse.gov/sites/default/files/
omb/assets/regulatory_matters_pdf/a4.pdf), in Table 13, we have prepared an
accounting statement showing the
classification of the expenditures
associated with the provisions of this
final rule. Table 13 provides our best
estimate of the possible changes in
Medicare payments under the SNF PPS
as a result of the policies in this final
rule, based on the data for 15,425 SNFs
in our database. All expenditures are
classified as transfers to Medicare
providers (that is, SNFs).
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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
12. As indicated in Table 12, the effect
on facilities is projected to be an
aggregate positive impact of 1.2 percent.
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
final rule will not have a significant
impact on a substantial number of small
entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 604 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area and has
fewer than 100 beds. This final 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 would be similar to
the impact on SNF providers overall.
Moreover, as noted in previous SNF PPS
final rules (most recently the one for FY
2015 (79 FR 45658)), the category of
small rural hospitals would be included
within the analysis of the impact of this
final rule on small entities in general.
As indicated in Table 12, the effect on
facilities is projected to be an aggregate
positive impact of 1.2 percent. As the
overall 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.
C. Unfunded Mandates Reform Act
Analysis
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2015, that
threshold is approximately $144
million. This final rule would not
impose spending costs on state, local, or
tribal governments in the aggregate, or
by the private sector, of $144 million.
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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations
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 final rule
will have no substantial direct effect on
state and local governments, preempt
state law, or otherwise have federalism
implications.
E. Congressional Review Act
This final 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.
In accordance with the provisions of
Executive Order 12866, this final rule
was reviewed by the Office of
Management and Budget.
List of Subjects in 42 CFR Part 483
Grant programs-health, Health
facilities, Health professions, Health
records, Medicaid, Medicare, Nursing
homes, Nutrition, Reporting and
recordkeeping requirements, Safety.
tkelley on DSK3SPTVN1PROD with RULES2
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
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PART 483—REQUIREMENTS FOR
STATES AND LONG TERM CARE
FACILITIES
1. The authority citation for part 483
is revised to read as follows:
■
Authority: Secs. 1102, 1128I, 1819, 1871
and 1919 of the Social Security Act (42
U.S.C. 1302, 1320a-7, 1395i, 1395hh and
1396r).
2. Section 483.75 is amended by
adding paragraph (u) to read as follows:
■
§ 483.75
Administration.
*
*
*
*
*
(u) Mandatory submission of staffing
information based on payroll data in a
uniform format. Long-term care
facilities must electronically submit to
CMS complete and accurate direct care
staffing information, including
information for agency and contract
staff, based on payroll and other
verifiable and auditable data in a
uniform format according to
specifications established by CMS.
(1) Direct Care Staff. Direct Care Staff
are those individuals who, through
interpersonal contact with residents or
resident care management, provide care
and services to allow residents to attain
or maintain the highest practicable
physical, mental, and psychosocial
well-being. Direct care staff does not
include individuals whose primary duty
is maintaining the physical environment
of the long term care facility (for
example, housekeeping).
(2) Submission requirements. The
facility must electronically submit to
CMS complete and accurate direct care
staffing information, including the
following:
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46477
(i) The category of work for each
person on direct care staff (including,
but not limited to, whether the
individual is a registered nurse, licensed
practical nurse, licensed vocational
nurse, certified nursing assistant,
therapist, or other type of medical
personnel as specified by CMS);
(ii) Resident census data; and
(iii) Information on direct care staff
turnover and tenure, and on the hours
of care provided by each category of
staff per resident per day (including, but
not limited to, start date, end date (as
applicable), and hours worked for each
individual).
(3) Distinguishing employee from
agency and contract staff. When
reporting information about direct care
staff, the facility must specify whether
the individual is an employee of the
facility, or is engaged by the facility
under contract or through an agency.
(4) Data format. The facility must
submit direct care staffing information
in the uniform format specified by CMS.
(5) Submission schedule. The facility
must submit direct care staffing
information on the schedule specified
by CMS, but no less frequently than
quarterly.
Dated: July 27, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Dated: July 28, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2015–18950 Filed 7–30–15; 4:15 pm]
BILLING CODE 4120–01–P
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04AUR2
]]>Agencies
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Rules and Regulations]
[Pages 46389-46477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18950]
[[Page 46389]]
Vol. 80
Tuesday,
No. 149
August 4, 2015
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 483
Medicare Program; Prospective Payment System and Consolidated Billing
for Skilled Nursing Facilities (SNFs) for FY 2016, SNF Value-Based
Purchasing Program, SNF Quality Reporting Program, and Staffing Data
Collection; Final Rule
Federal Register / Vol. 80 , No. 149 / Tuesday, August 4, 2015 /
Rules and Regulations
[[Page 46390]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 483
[CMS-1622-F]
RIN 0938-AS44
Medicare Program; Prospective Payment System and Consolidated
Billing for Skilled Nursing Facilities (SNFs) for FY 2016, SNF Value-
Based Purchasing Program, SNF Quality Reporting Program, and Staffing
Data Collection
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule updates the payment rates used under the
prospective payment system (PPS) for skilled nursing facilities (SNFs)
for fiscal year (FY) 2016. In addition, it specifies a SNF all-cause
all-condition hospital readmission measure, as well as adopts that
measure for a new SNF Value-Based Purchasing (VBP) Program, and
includes a discussion of SNF VBP Program policies we are considering
for future rulemaking to promote higher quality and more efficient
health care for Medicare beneficiaries. Additionally, this final rule
will implement a new quality reporting program for SNFs as specified in
the Improving Medicare Post-Acute Care Transformation Act of 2014
(IMPACT Act). It also amends the requirements that a long-term care
(LTC) facility must meet to qualify to participate as a skilled nursing
facility (SNF) in the Medicare program, or a nursing facility (NF) in
the Medicaid program, by establishing requirements that implement the
provision in the Affordable Care Act regarding the submission of
staffing information based on payroll data.
DATES: Effective date: The provisions of this final rule are effective
on October 1, 2015 with the exception of provisions in Sec. 483.75(u)
which are effective on July 1, 2016.
FOR FURTHER INFORMATION CONTACT:
Penny Gershman, (410) 786-6643, for information related to SNF PPS
clinical issues (excluding any issues raised in section III.D. of this
final rule).
John Kane, (410) 786-0557, for information related to the
development of the payment rates and case-mix indexes.
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, consolidated billing, and general information.
Shannon Kerr, (410) 786-0666, for information related to skilled
nursing facility value-based purchasing.
Charlayne Van, (410) 786-8659, for information related to skilled
nursing facility quality reporting.
Lorelei Chapman, (410) 786-9254, for information related to
staffing data collection.
SUPPLEMENTARY INFORMATION:
Availability of Certain Tables Exclusively Through the Internet on the
CMS Web Site
As discussed in the FY 2016 SNF PPS proposed rule (80 FR 22044),
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
Web site. The wage index tables for this final rule can be accessed on
the SNF PPS Wage Index homepage, 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
II. Background on SNF PPS
A. Statutory Basis and Scope
B. Initial Transition for the SNF PPS
C. Required Annual Rate Updates
III. Analysis of and Responses to Public Comments on the FY 2016 SNF
PPS Proposed Rule
A. General Comments on the FY 2016 SNF PPS Proposed Rule
B. SNF PPS Rate Setting Methodology and FY 2016 Update
1. Federal Base Rates
2. SNF Market Basket Update
a. SNF Market Basket Index
b. Use of the SNF Market Basket Percentage
c. Forecast Error Adjustment
d. Multifactor Productivity Adjustment
(1) Incorporating the Multifactor Productivity Adjustment Into
the Market Basket Update
e. Market Basket Update Factor for FY 2016
3. Case-Mix Adjustment
4. Wage Index Adjustment
5. Adjusted Rate Computation Example
C. Additional Aspects of the SNF PPS
1. SNF Level of Care--Administrative Presumption
2. Consolidated Billing
3. Payment for SNF-Level Swing-Bed Services
D. Other Issues
1. SNF Value-Based Purchasing (VBP) Program
a. Background
(1) Overview
(2) SNF VBP Report to Congress
b. Statutory Basis for the SNF VBP Program
c. Skilled Nursing Facility 30-Day All-Cause Readmission Measure
(SNFRM)
(1) Overview
(2) Measure Calculation
(3) Exclusions
(4) Eligible Readmissions
(5) Risk Adjustment
(6) Measurement Period
(7) Stakeholder/MAP Input
(8) Feedback Reports to SNFs
d. Performance Standards
(1) Background
(a) Hospital Value-Based Purchasing Program
(b) Hospital-Acquired Conditions Reduction Program
(c) Hospital Readmissions Reduction Program (HRRP)
(d) End-Stage Renal Disease Quality Incentive Program (ESRD QIP)
(2) Measuring Improvement
e. FY 2019 Performance Period and Baseline Period Considerations
(1) Performance Period
(2) Baseline Period
f. SNF Performance Scoring
(1) Considerations
(a) Hospital Value-Based Purchasing
(b) Hospital-Acquired Conditions Reduction Program
(c) Other Considerations
(2) Notification Procedures
(3) Exchange Function
g. SNF Value-Based Incentive Payments
h. SNF VBP Public Reporting
(1) SNF-Specific Performance Information
(2) Aggregate Performance Information
2. Advancing Health Information Exchange
3. SNF Quality Reporting Program (QRP)
a. Background and Statutory Authority
b. General Considerations Used for Selection of Quality Measures
for the SNF QRP
c. Policy for Retaining SNF QRP Measures for Future Payment
Determinations
d. Process for Adoption of Changes to SNF QRP Program Measures
e. New Quality Measures for FY 2018 and Subsequent Payment
Determinations
(1) Quality Measure Addressing the Domain of Skin Integrity and
Changes in Skin Integrity: Percent of Residents or Patients With
Pressure Ulcers That are New or Worsened (Short Stay) (NQF #0678)
(2) Quality Measure Addressing the Domain of the Incidence of
Major Falls: An Application of the Measure Percent of Residents
Experiencing One or More Falls With Major Injury (Long Stay) (NQF
#0674)
(3) Quality Measure Addressing the Domain of Functional Status,
Cognitive
[[Page 46391]]
Function, and Changes in Function and Cognitive Function:
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; under NQF review)
f. SNF QRP Quality Measures Under Consideration for Future Years
g. Form, Manner, and Timing of Quality Data Submission
(1) Participation/Timing for New SNFs
(2) Data Collection Timelines and Requirements for the FY 2018
Payment Determination and Subsequent Years
h. SNF QRP Data Completion Thresholds for FY 2018 Payment
Determination and Subsequent Years
i. SNF QRP Data Validation Requirements for the FY 2018 Payment
Determination and Subsequent Years
j. SNF QRP Submission Exception and Extension Requirements for
the FY 2018 Payment Determination and Subsequent Years
k. SNF QRP Reconsideration and Appeals Procedures for the FY
2018 Payment Determination and Subsequent Years
l. Public Display of Quality Measure Data for the SNF QRP
m. Mechanism for Providing Feedback Reports to SNFs
4. Staffing Data Collection
a. Background and Statutory Authority
b. Provisions of the Proposed Rule and Responses to Comments
(1) Consultation on Specifications
(2) Scope of Submission Requirements
(3) Hours Worked and Hours of Care
(4) Distinguishing Employees From Agency and Contract Staff
(5) Data Format
(6) Effective Date for Submission Requirement
(7) Submission Schedule
(8) Compliance and Enforcement
(9) Other Comments
c. Provisions of the Final Rule
IV. Collection of Information Requirements
V. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
2. Statement of Need
3. Overall Impacts
4. Detailed Economic Analysis
5. Alternatives Considered
6. Accounting Statement
7. Conclusion
B. Regulatory Flexibility Act Analysis
C. Unfunded Mandates Reform Act Analysis
D. Federalism Analysis
E. Congressional Review Act
Regulation Text
Acronyms
In addition, because of the many terms to which we refer by acronym
in this final rule, we are listing these abbreviations and their
corresponding terms in alphabetical order below:
AIDS Acquired Immune Deficiency Syndrome
ARD Assessment reference date
BBA Balanced Budget Act of 1997, Pub. L. 105-33
BBRA Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999, Public Law 106-113
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement and
Protection Act of 2000, Public Law 106-554
CAH Critical access hospital
CASPER Certification and Survey Provider Enhanced Reports
CBSA Core-based statistical area
CCN CMS Certification Number
CFR Code of Federal Regulations
CMI Case-mix index
CMS Centers for Medicare & Medicaid Services
COT Change of therapy
ECI Employment Cost Index
EHR Electronic health record
EOT End of therapy
EOT-R End of therapy--resumption
ESRDQIP End-Stage Renal Disease Quality Incentive Program
FAQ Frequently Asked Questions
FFS Fee-for-service
FR Federal Register
FY Fiscal year
GAO Government Accountability Office
HAC Hospital-Acquired Conditions
HACRP Hospital-Acquired Condition Reduction Program
HCPCS Healthcare Common Procedure Coding System
HIQR Hospital Inpatient Quality Reporting
HOQR Hospital Outpatient Quality Reporting
HRRP Hospital Readmissions Reduction Program
HVBP Hospital Value-Based Purchasing
ICR Information Collection Requirements
IGI IHS (Information Handling Services) Global Insight, Inc.
IMPACT Improving Medicare Post-Acute Care Transformation Act of
2014, Public Law 113-185
IPPS Inpatient prospective payment system
IRF Inpatient Rehabilitation Facility
LTC Long-term care
LTCH Long-term care hospital
MAP Measures Application Partnership
MDS Minimum data set
MFP Multifactor productivity
MMA Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, Public Law 108-173
MSA Metropolitan statistical area
NAICS North American Industrial Classification System
NF Nursing facility
NH Nursing Home
NQF National Quality Forum
OBRA Omnibus Budget Reconciliation Act of 1987, Public Law 100-203
OMB Office of Management and Budget
OMRA Other Medicare-Required Assessment
PAC Post-acute care
PAMA Protecting Access to Medicare Act of 2014, Public Law 113-93
PBJ Payroll-Based Journal
PPS Prospective Payment System
PQRS Physician Quality Reporting System
QIES Quality Improvement Evaluation System
QIES ASAP Quality Improvement and Evaluation System Assessment
Submission and Processing
QRP Quality Reporting Program
RAI Resident assessment instrument
RAVEN Resident assessment validation entry
RFA Regulatory Flexibility Act, Public Law 96-354
RIA Regulatory impact analysis
RUG-III Resource Utilization Groups, Version 3
RUG-IV Resource Utilization Groups, Version 4
RUG-53 Refined 53-Group RUG-III Case-Mix Classification System
SCHIP State Children's Health Insurance Program
sDTI Suspected deep tissue injuries
SNF Skilled nursing facility
SNFRM Skilled Nursing Facility 30-Day All-Cause Readmission Measure
STM Staff time measurement
STRIVE Staff time and resource intensity verification
TEP Technical expert panel
UMRA Unfunded Mandates Reform Act, Public Law 104-4
VBP Value-based purchasing
I. Executive Summary
A. Purpose
This final rule updates the SNF prospective payment rates for FY
2016 as required under section 1888(e)(4)(E) of the Social Security Act
(the Act). It also responds 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 fiscal
year (FY), certain specified information relating to the payment update
(see section II.C.). In addition, it implements a new quality reporting
program (QRP) for SNFs required under section 1888(e)(6) of the Act.
The final rule also specifies a SNF all-cause all-condition hospital
readmission measure required under section 1888(g)(1) of the Act, and
adopts that measure for a new SNF value-based purchasing (VBP) program
as required under section 1888(h) of the Act. Further, this final rule
establishes new regulatory reporting requirements for SNFs and NFs to
implement the statutory obligation to submit staffing information based
on payroll data under section 1128I(g) of the Act.
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 final rule reflect an update to the
rates that we published in the SNF PPS final rule for FY 2015 (79 FR
45628), which reflects the SNF market basket index as adjusted by the
applicable forecast error correction and by the multifactor
productivity adjustment for FY 2016. We are also finalizing a SNF all-
cause all-condition hospital readmission measure under section
1888(g)(1) of the
[[Page 46392]]
Act, as well as adopting that measure for a new SNF VBP Program as
required under section 1888(h) of the Act. We are also implementing a
new QRP for SNFs under section 1888(e)(6) of the Act, which was added
by section 2(c)(4) of the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act, Pub. L. 113-185).
For payment determinations beginning with FY 2018, we are adopting
measures meeting three quality domains specified in section 1899B(c)(1)
of the Act: Functional status, skin integrity, and incidence of major
falls.
In addition, we are adding new language at 42 CFR, part 483 to
implement section 1128I(g) of the Act. Specifically, beginning on July
1, 2016, long-term care (LTC) facilities that participate in Medicare
or Medicaid will be required to submit electronically direct care
staffing information (including information for agency and contract
staff) based on payroll and other verifiable and auditable data in a
uniform format.
C. Summary of Cost and Benefits
------------------------------------------------------------------------
Provision description Total transfers
------------------------------------------------------------------------
FY 2016 SNF PPS payment rate update.... The overall economic impact of
this final rule will be an
estimated increase of $430
million in aggregate payments
to SNFs during FY 2016.
------------------------------------------------------------------------
II. Background on SNF PPS
A. Statutory Basis and Scope
As amended by section 4432 of the Balanced Budget Act of 1997 (BBA,
Pub. L. 105-33), 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 physician 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 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_07302013.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 certain quality measures
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(a) of the IMPACT Act added section 1899B
to the Act that, among other things, requires SNFs to report
standardized data for measures in specified quality and resource use
domains. In addition, the IMPACT Act added section 1888(e)(6) to the
Act, which requires the Secretary to implement a QRP for SNFs, under
which SNFs that do not report certain data will receive a reduction in
their payments under the SNF PPS of 2 percentage points for FYs
beginning with FY 2018.
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 three 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
2015 (79 FR 45628, August 5, 2014).
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
final rule provides the required annual updates to the per diem payment
rates for SNFs for FY 2016.
III. Analysis of and Responses to Public Comments on the FY 2016 SNF
PPS Proposed Rule
In response to the publication of the FY 2016 SNF PPS proposed
rule, we received 53 timely public comments from individuals,
providers, corporations, government agencies, private citizens, trade
associations, and major organizations. The following are brief
summaries of each proposed provision, a summary of the public comments
that we received related to that proposal, and our responses to the
comments.
A. General Comments on the FY 2016 SNF PPS Proposed Rule
In addition to the comments we received on specific proposals
contained within the proposed rule (which we address later in this
final rule), commenters also submitted the following, more general
observations on the SNF PPS and SNF care generally. A discussion of
these comments, along with our responses, appears below.
Comment: One commenter expressed concern regarding the recent
evolution of SNF care, stating that, in the commenter's opinion, while
resident acuity is increasing, facilities worry more about money than
about actual resident care. The commenter further stated that fewer
staff hours should be focused on determining a resident's particular
Resource Utilization Group (RUG) level for the purpose of managing
facility budgets, and instead should be focused on resident care.
Additionally, the commenter asked that we establish standards of
practice to eliminate unwarranted variability in care, such as
residents sharing various health characteristics but receiving very
different amounts of care.
Response: We appreciate the commenter raising these points and are
mindful of the commenter's concern regarding the apparent tension
between profit and resident care. We also agree
[[Page 46393]]
that SNF care appropriately should focus on the resident's unique
characteristics and goals, and note that RUG determinations should be
based on the type and amount of nursing and therapy care required by
the resident, rather than on facility budget considerations. We will
consider the concerns the commenter raised as we identify future areas
for analysis and program monitoring.
Comment: One commenter recommended that we address the need for CMS
to broaden the categories of healthcare professionals who may order
patient diets. The commenter stated that such a change would improve
patient health and allow SNFs to respond more quickly to resident
nutritional needs.
Response: We appreciate this comment, but would note as we did in
the FY 2015 SNF PPS final rule (79 FR 45630) that the specific issues
the commenter raised about who may prescribe diets for SNF residents do
not relate to payment policy, but rather to certification standards for
long-term care facilities more generally. Therefore, while we once
again note that such comments lie outside of the scope of this final
rule, we will share them with the relevant CMS staff that works on
survey and certification issues.
Comment: Several commenters made comments related to potential
refinements or revisions of the existing SNF PPS. Some commenters
expressed concern regarding compensation for non-therapy ancillary
services, with one commenter stating specifically that the SNF PPS
emphasizes therapy services and deemphasizes the care needs for
medically complex residents, particularly in hospital-based SNFs. A
second commenter stated that the current RUG system does not
appropriately capture the intensity or cost of services for residents
in certain non-therapy RUG groups, most notably those resident living
with Alzheimer's disease and dementia. Both commenters urged CMS to
revise the SNF PPS to account for the potentially increased intensity
or cost of services for medically complex residents, some of which may
result from the provision of non-therapy ancillary services. One
commenter expressed a ``growing impatience'' with CMS's lack of
progress in implementing a revised SNF PPS and urged CMS to move
forward with a revised PPS design or provide a timeline for when such
revisions will be ready given that the flaws with the current system
are already well known. A different commenter expressed support for
CMS's current efforts to revise the SNF PPS, while at the same time
cautioning CMS to proceed gradually by considering an approach that
would transition to a revised PPS design over time.
Response: We appreciate the commenters raising these points and
share the commenters' interest in exploring ways to revise the SNF PPS
that may improve payment policy as well as promote appropriate resident
care. We believe that our SNF payment model research (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/therapyresearch.html) will help us establish a strong basis for
examining potential improvements and refinements to the overall SNF
PPS, most notably given that we recently expanded the scope of this
research to focus not only on therapy payment but nursing and non-
therapy ancillary payments as well. With regard to comments on the
overall approach CMS is taking in developing a revised PPS design, and
specifically, the two comments that presented contrasting views on the
pace of our progress, we would agree with the commenter who urged a
certain degree of caution in moving to a revised SNF PPS. While we also
agree that many of the issues with the current system are well known at
this point, we believe that arriving at appropriate solutions to issues
of this complexity will, of necessity, entail an investment of time and
effort that goes considerably beyond simply identifying the issues
themselves. That said, we do believe that we should continue to move as
quickly as possible to address the issues with the existing SNF PPS
design, though without compromising the overall integrity of our
research and analysis for the sake of time. We also welcome additional
comments and feedback on this research, which may be submitted to:
SNFTherapyPayments@cms.hhs.gov.
Comment: One commenter raised a concern regarding the potential
impact of current Minimum Data Set (MDS) 3.0 assessment rules and
policies during facility audits of completed MDS assessments.
Specifically, the commenter stated that during an audit of assessments
completed by a given facility, it might be discovered that correcting a
given error (for example, an error in the number of therapy minutes
coded on a given assessment) also means that a Change-of-Therapy (COT)
Other Medicare-Required Assessment (OMRA) may have been missed during
that timeframe when the original error occurred. Due to the missed
assessment policy outlined in Chapters 2 and 6 of the MDS 3.0 manual,
this could mean that the days associated with that missed assessment
could be considered provider liable, which could have a significant
financial impact on the facility. The commenter recommended that CMS
re-evaluate the potentially punitive impact of not being able to
complete an MDS after the resident's Medicare-covered SNF stay has
ended.
Response: The consequences associated with coding errors and the
use of audits to identify these errors are necessary to ensure that
SNFs take seriously the responsibility of ensuring that accurate
information is coded on the MDS. While we appreciate that errors are
always possible, we do not believe that this is sufficient to warrant a
change in policy at this time. We will continue to consider this issue
as part of our ongoing evaluation of potential refinements and
improvements to the overall SNF PPS.
B. SNF PPS Rate Setting Methodology and FY 2016 Update
1. 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 have been 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 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
[[Page 46394]]
costs by a wage index to reflect geographic variations in wages.
2. SNF Market Basket Update
a. 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. We use the
SNF market basket index, adjusted in the manner described below, to
update the federal rates on an annual basis. In the SNF PPS final rule
for FY 2014 (78 FR 47939 through 47946), we revised and rebased the
market basket, which included updating the base year from FY 2004 to FY
2010.
For the FY 2016 proposed rule, the FY 2010-based SNF market basket
growth rate was estimated to be 2.6 percent, which was based on the IHS
Global Insight, Inc. (IGI) first quarter 2015 forecast with historical
data through fourth quarter 2014. However, as discussed in the FY 2016
SNF PPS proposed rule (80 FR 22049), we proposed that if more recent
data become available (for example, a more recent estimate of the FY
2010-based SNF market basket and/or MFP adjustment), we would use such
data, if appropriate, to determine the FY 2016 SNF market basket
percentage change, labor-related share relative importance, forecast
error adjustment, and MFP adjustment in this final rule. Since that
time we have received an updated FY 2016 market basket percentage
increase, which is based on the second quarter 2015 IHS Global Insight
forecast of the FY 2010-based SNF market basket. The revised market
basket growth rate is 2.3 percent. In section III.B.2.e. of this final
rule, we discuss the specific application of this adjustment to the
forthcoming annual update of the SNF PPS payment rates.
b. 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 final rule, we use the percentage
change in the SNF market basket index to compute the update factor for
FY 2016. This is based on the IGI second quarter 2015 forecast (with
historical data through the first quarter 2015) of the FY 2016
percentage increase in the FY 2010-based SNF market basket index for
routine, ancillary, and capital-related expenses, which is used to
compute the update factor in this final rule. As discussed in sections
III.B.2.c. and III.B.2.d. of this final rule, this market basket
percentage change is reduced by the applicable forecast error
correction (as described in Sec. 413.337(d)(2)) and by the multifactor
productivity adjustment as required by section 1888(e)(5)(B)(ii) of the
Act. Finally, as discussed in section II.B. of this final 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.
c. 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), the regulations at Sec. 413.337(d)(2) provide 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 2014 (the most recently available FY for which there is
final data), the estimated increase in the market basket index was 2.3
percentage points, while the actual increase for FY 2014 was 1.7
percentage points, resulting in the actual increase being 0.6
percentage point lower than the estimated increase. Accordingly, as the
difference between the estimated and actual amount of change in the
market basket index exceeds the 0.5 percentage point threshold and
because, in this instance, the estimated amount of change exceeded the
actual amount of change, the FY 2016 market basket percentage change of
2.3 percent would be adjusted downward by the forecast error correction
of 0.6 percentage point, resulting in a SNF market basket increase of
1.7 percent, before application of the productivity adjustment
discussed in this section. Table 1 shows the forecasted and actual
market basket amounts for FY 2014.
Table 1--Difference Between the Forecasted and Actual Market Basket Increases for FY 2014
----------------------------------------------------------------------------------------------------------------
Forecasted FY Actual FY 2014 FY 2014
Index 2014 increase * increase ** Difference
----------------------------------------------------------------------------------------------------------------
SNF.......................................................... 2.3 1.7 -0.6
----------------------------------------------------------------------------------------------------------------
* Published in Federal Register; based on second quarter 2013 IGI forecast (2010-based index).
** Based on the first quarter 2015 IGI forecast, with historical data through the fourth quarter 2014 (2010-
based index).
A discussion of the general comments that we received on the
forecast error adjustment, and our responses to those comments, appears
below.
Comment: One commenter requested that in determining the need for a
market basket forecast error adjustment in a given year, CMS consider
recalculating the wage index budget neutrality factor (discussed in
section III.B.4 of this final rule) based on more recent data and
utilize any error found in the original budget neutrality factor
calculation in CMS's determination of the need for a market basket
forecast error adjustment.
Response: The commenter appears to be requesting a wage index
budget
[[Page 46395]]
neutrality factor error adjustment. However, we note at the outset that
given the limited year-to-year variance in the wage index budget
neutrality factor, any calculation of a budget neutrality factor error
would likely represent an error of no more than a few thousandths of a
percentage point, and thus we do not believe a wage index budget
neutrality factor error adjustment would be necessary. Moreover, the
market basket forecast error adjustment and the wage index budget
neutrality factor serve fundamentally different purposes and involve
entirely separate aspects of the SNF PPS. As such, we do not believe it
would be appropriate to apply a wage index budget neutrality factor
error to a market basket forecast error in order to determine if the
market basket forecast error adjustment should be made.
Comment: One commenter stated that the forecast error adjustment of
0.6 percentage point represents a significant reduction and recommended
that we implement the forecast error correction over a 2-year period.
Response: The forecast error adjustment is an essential aspect of
ensuring that SNF PPS payments are as accurate as possible. Therefore,
consistent with the way we have applied forecast error adjustments in
the past, we do not believe that it is either appropriate or beneficial
to the overall integrity of the SNF PPS to implement this adjustment
over a multiple-year period.
d. Multifactor Productivity Adjustment
Section 3401(b) of the Affordable Care Act 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 productivity adjustment described in
section 1886(b)(3)(B)(xi)(II) of the Act. Section 1886(b)(3)(B)(xi)(II)
of the Act, added by section 3401(a) of the Affordable Care Act, sets
forth the definition of this productivity adjustment. The statute
defines the productivity 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 MFP adjustment). The Bureau of Labor
Statistics (BLS) is the agency that publishes the official measure of
private nonfarm business multifactor productivity (MFP). We refer
readers to the BLS Web site 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. In
section III.F.3. of the FY 2012 SNF PPS final rule (76 FR 48527 through
48529), we identified each of the major MFP component series employed
by the BLS to measure MFP as well as provided the corresponding
concepts determined to be the best available proxies for the BLS
series.
Beginning with the FY 2016 rulemaking cycle, the MFP adjustment is
calculated using a revised series developed by IGI to proxy the
aggregate capital inputs. Specifically, IGI has replaced the Real
Effective Capital Stock used for Full Employment GDP with a forecast of
BLS aggregate capital inputs recently developed by IGI using a
regression model. This series provides a better fit to the BLS capital
inputs as measured by the differences between the actual BLS capital
input growth rates and the estimated model growth rates over the
historical time period. Therefore, we are using IGI's most recent
forecast of the BLS capital inputs series in the MFP calculations
beginning with the FY 2016 rulemaking cycle. A complete description of
the MFP projection methodology is available on our Web site at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html. Although
we discuss the IGI changes to the MFP proxy series in this final rule,
in the future, when IGI makes changes to the MFP methodology, we will
announce them on our Web site rather than in the annual rulemaking.
(1) Incorporating the Multifactor Productivity Adjustment Into the
Market Basket Update
According to 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) (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 for a
FY being less than such payment rates for the preceding FY. 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.
For the FY 2016 update, the MFP adjustment is calculated as the 10-
year moving average of changes in MFP for the period ending September
30, 2016. In the FY 2016 SNF PPS proposed rule, this adjustment was
calculated to be 0.6 percent. However, as discussed in the FY 2016 SNF
PPS proposed rule (80 FR 22049), we proposed that if more recent data
become available (for example, a more recent estimate of the FY 2010-
based SNF market basket and/or MFP adjustment), we would use such data,
if appropriate, to determine, among other things, the FY 2016 SNF
market basket percentage change and the MFP adjustment in this final
rule. Therefore, based on IGI's most recent second quarter 2015
forecast (with historical data through first quarter 2015), the MFP
adjustment for FY 2016 is 0.5 percent. Consistent with section
1888(e)(5)(B)(i) of the Act and Sec. 413.337(d)(2) of the regulations,
the market basket percentage for FY 2016 for the SNF PPS is based on
IGI's second quarter 2015 forecast of the SNF market basket update (2.3
percent) as adjusted by the forecast error adjustment (0.6 percentage
point), and is estimated to be 1.7 percent. In accordance with section
1888(e)(5)(B)(ii) of the Act (as added by section 3401(b) of the
Affordable Care Act) and Sec. 413.337(d)(3), this market basket
percentage is then reduced by the MFP adjustment (the 10-year moving
average of changes in MFP for the period ending September 30, 2016) of
0.5 percent, which is calculated as described above and based on IGI's
second quarter 2015 forecast. The
[[Page 46396]]
resulting MFP-adjusted SNF market basket update is equal to 1.2
percent, or 1.7 percent less 0.5 percentage point.
e. Market Basket Update Factor for FY 2016
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 2016 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, 2014 through September 30,
2015 to the average market basket level for the period of October 1,
2015 through September 30, 2016. This process yields a percentage
change in the market basket of 2.3 percent.
As further explained in section III.B.2.c. of this final 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 forecasted FY 2014
SNF market basket percentage change exceeded the actual FY 2014 SNF
market basket percentage change (FY 2014 is the most recently available
FY for which there is final data) by more than 0.5 percentage point,
the FY 2016 market basket percentage change of 2.3 percent would be
adjusted downward by the applicable difference, which for FY 2014 is
0.6 percent.
In addition, for FY 2016, section 1888(e)(5)(B)(ii) of the Act
requires us to reduce the market basket percentage change by the MFP
adjustment (the 10-year moving average of changes in MFP for the period
ending September 30, 2016) of 0.5 percent, as described in section
III.B.2.d. of this final rule. The resulting net SNF market basket
update would equal 1.2 percent, or 2.3 percent less the 0.6 percentage
point forecast error adjustment, less the 0.5 percentage point MFP
adjustment. We proposed in the FY 2016 SNF PPS proposed rule (80 FR
22049) that if more recent data become available (for example, a more
recent estimate of the FY 2010-based SNF market basket and/or MFP
adjustment), we would use such data, if appropriate, to determine the
FY 2016 SNF market basket percentage change, labor-related share
relative importance, forecast error adjustment, and MFP adjustment in
this final rule. As noted above, more recent data were used to update
the market basket update and MFP adjustment in this final rule.
A discussion of the general comments that we received on the market
basket update factor for FY 2016, and our responses to those comments,
appears below.
Comment: We received a number of comments in relation to applying
the FY 2016 market basket update factor in the determination of the FY
2016 unadjusted federal per diem rates, with some commenters supporting
its application in determining the FY 2016 unadjusted per diem rates,
while others opposed its application. In their March 2015 report
(available at: https://www.medpac.gov/documents/reports/chapter-8-skilled-nursing-facility-services-(march-2015-report).pdf?sfvrsn=0) and
in their comment on the FY 2016 SNF PPS proposed rule, MedPAC
recommended that CMS eliminate the market basket update for SNFs
altogether and rebase payments for the SNF PPS, beginning with a 4
percent reduction in the base payment rates.
Response: We appreciate all of the comments received on the
proposed market basket update for FY 2016. In response to those
comments which opposed our applying the FY 2016 market basket update
factor in determining the FY 2016 unadjusted federal per diem rates,
specifically MedPAC's proposal to eliminate the market basket update
for SNFs and to implement a 4 percent reduction to the SNF PPS base
rates, we would need statutory authority to act on these proposals at
the current time.
Comment: One commenter stated that in their preliminary analyses,
they observed a gap between the market basket and costs indexed to 2001
dollars (which we assume to mean an index based on 2001 dollars) which
occurs even in rebasing years. They also observed a growing gap in non-
labor components. They stated that further research is needed to
understand the gap and they respectfully request that CMS engage in an
ongoing dialogue.
Response: We appreciate the commenter's review of the SNF market
basket methodology and look forward to the commenter's analysis. While
any comments on the SNF market basket methodology, including any
analyses, can be emailed to DNHS@cms.hhs.gov, we would be happy to
engage in further dialogue on this issue.
Comment: One commenter noted that the weights used in calculating
the market basket update should continue to use the most updated cost
data available. They suggested that the market basket be revised and
reweighted with greater frequency--on the same schedule as the hospital
market basket, particularly given the new Medicare provisions, such as
the IMPACT Act and also if the SNF wage index continues to be directly
linked to the hospital wage index. The commenter also suggested that
CMS update the market basket each year; alternatively, should such a
process be too onerous, CMS should calculate the six major cost weights
derived from the Medicare cost report (wages and salaries, employee
benefits, contract labor, pharmaceuticals, professional liability
insurance and capital-related) every year and update the market basket
every 4 years (rather than every 6), as well as whenever the aggregate
percentage change of the six major cost weights, when taken together,
exceeds some set amount.
Response: We appreciate the commenter's request for the SNF market
basket to be revised and reweighted more frequently. As discussed in
the FY 2006 IPPS final rule (70 FR 47387), we established a rebasing
frequency of every 4 years for the hospital market basket, in
accordance with section 404 of Public Law 108-173. We typically rebase
and revise the SNF market baskets approximately every 6 years. Our
prior analysis has shown that the major cost weights do not vary that
much from year to year. However, we do understand the commenter's
concern for more frequent rebasings given that any changes in the
Medicare law could alter the way in which SNFs provide Medicare
services--which, in turn, potentially could affect the SNF cost
structures (that is, the market basket cost weights). Accordingly, we
will consider the methodology presented by the commenter and evaluate
the possible impact on the SNF market basket update by monitoring the
percent change of the six major cost weights derived from the Medicare
cost report (wages and salaries, employee benefits, contract labor,
pharmaceuticals, professional liability insurance and capital-related).
Accordingly, for the reasons specified in this final rule and in
the FY 2016 SNF PPS proposed rule (80 FR 22047 through 22049), we are
applying the FY 2016 market basket increase factor, as adjusted by the
forecast error correction and MFP adjustment as described above, in our
determination of the FY 2016 SNF PPS unadjusted federal per diem rates.
We used the SNF market basket, adjusted as described in this section,
to adjust each per diem component of the federal rates forward to
reflect the change in the average prices for FY 2016 from average
prices for FY 2015. We would further adjust the rates by a wage index
budget neutrality factor, described later in this
[[Page 46397]]
section. Tables 2 and 3 reflect the updated components of the
unadjusted federal rates for FY 2016, prior to adjustment for case-mix.
Table 2--FY 2016 Unadjusted Federal Rate Per Diem Urban
----------------------------------------------------------------------------------------------------------------
Nursing--case- Therapy--case- Therapy--non-
Rate component mix mix case-mix Non-case-mix
----------------------------------------------------------------------------------------------------------------
Per Diem Amount............................. $171.17 $128.94 $16.98 $87.36
----------------------------------------------------------------------------------------------------------------
Table 3--FY 2016 Unadjusted Federal Rate Per Diem Rural
----------------------------------------------------------------------------------------------------------------
Nursing--case- Therapy--case- Therapy--non-
Rate component mix mix case-mix Non-case-mix
----------------------------------------------------------------------------------------------------------------
Per Diem Amount............................. $163.53 $148.67 $18.14 $88.97
----------------------------------------------------------------------------------------------------------------
3. 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 interim final
rule with comment period that initially implemented the SNF PPS (63 FR
26252, May 12, 1998), we developed the RUG-III case-mix classification
system, which tied the amount of payment to resident resource use in
combination with resident characteristic information. Staff time
measurement (STM) studies conducted in 1990, 1995, and 1997 provided
information on resource use (time spent by staff members on residents)
and resident characteristics that enabled us not only to establish RUG-
III, but also to create case-mix indexes (CMIs). The original RUG-III
grouper logic was based on clinical data collected in 1990, 1995, and
1997. As discussed in the SNF PPS proposed rule for FY 2010 (74 FR
22208), we subsequently conducted a multi-year data collection and
analysis under the Staff Time and Resource Intensity Verification
(STRIVE) project to update the case-mix classification system for FY
2011. The resulting Resource Utilization Groups, Version 4 (RUG-IV)
case-mix classification system reflected the data collected in 2006
through 2007 during the STRIVE project, and was finalized in the FY
2010 SNF PPS final rule (74 FR 40288) to take effect in FY 2011
concurrently with an updated new resident assessment instrument,
version 3.0 of the Minimum Data Set (MDS 3.0), which collects the
clinical data used for case-mix classification under RUG-IV.
We note that case-mix classification is based, in part, on the
beneficiary's need for skilled nursing care and therapy services. The
case-mix classification system uses clinical data from the MDS to
assign a case-mix group to each patient that is then used to calculate
a per diem payment under the SNF PPS. As discussed in section III.C.1.
of this final 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 time frames 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 Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html.
In addition, we note that section 511 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (MMA, Pub. L. 108-173)
amended section 1888(e)(12) of the Act to provide for a temporary
increase of 128 percent in the PPS per diem payment for any SNF
residents with Acquired Immune Deficiency Syndrome (AIDS), effective
with services furnished on or after October 1, 2004. This special add-
on for SNF residents with AIDS was to remain in effect until the
Secretary certifies that there is an appropriate adjustment in the case
mix to compensate for the increased costs associated with such
residents. The add-on for SNF residents with AIDS is also discussed in
Program Transmittal #160 (Change Request #3291), issued on April 30,
2004, which is available online at www.cms.gov/transmittals/downloads/r160cp.pdf. In the SNF PPS final rule for FY 2010 (74 FR 40288), we did
not address the certification related to the add-on for SNF residents
with AIDS in that final rule's implementation of the case-mix
refinements for RUG-IV, thus allowing the add-on payment required by
section 511 of the MMA to remain in effect. For the limited number of
SNF residents that qualify for this add-on, there is a significant
increase in payments. For example, using FY 2013 data, we identified
fewer than 4,800 SNF residents with a diagnosis code of 042 (Human
Immunodeficiency Virus (HIV) Infection). For FY 2016, an urban facility
with a resident with AIDS in RUG-IV group ``HC2'' would have a case-mix
adjusted per diem payment of $427.85 (see Table 4) before the
application of the MMA adjustment. After an increase of 128 percent,
this urban facility would receive a case-mix adjusted per diem payment
of approximately $975.50.
Currently, we use the International Classification of Diseases, 9th
revision, Clinical Modification (ICD-9-CM) code 042 to identify those
residents for whom it is appropriate to apply the AIDS add-on
established by section 511 of the MMA. In this context, we note that
the Department published a final rule in the September 5, 2012 Federal
Register (77 FR 54664) which requires us to stop using ICD-9-CM on
September 30, 2014, and begin using the International Classification of
Diseases, 10th revision, Clinical Modification (ICD-10-CM), on October
1, 2014. Regarding the above-referenced ICD-9-CM diagnosis code of
[[Page 46398]]
042, in the FY 2014 SNF PPS proposed rule (78 FR 26444, May 6, 2013),
we proposed to transition to the equivalent ICD-10-CM diagnosis code of
B20 upon the overall conversion to ICD-10-CM on October 1, 2014, and we
subsequently finalized that proposal in the FY 2014 SNF PPS final rule
(78 FR 47951 through 47952).
However, on April 1, 2014, PAMA was enacted. Section 212 of PAMA,
titled ``Delay in Transition from ICD-9 to ICD-10 Code Sets,'' provides
that the Secretary of Health and Human Services may not, prior to
October 1, 2015, adopt ICD-10 code sets as the standard for code sets
under section 1173(c) of the Act (42 U.S.C. 1320d-2(c)) and 45 CFR
162.1002. In the FY 2015 SNF PPS final rule (79 FR 45633), we stated
that the Department expected to release an interim final rule in the
near future that would include a new compliance date that would require
the use of ICD-10 beginning October 1, 2015. In light of this, in the
FY 2015 SNF PPS final rule, we stated that the effective date of the
change from ICD-9-CM code 042 to ICD-10-CM code B20 for purposes of
applying the AIDS add-on is October 1, 2015, and that until that time
we would continue to use the ICD-9-CM code 042 for this purpose. On
August 4, 2014, HHS released a final rule in the Federal Register (79
FR 45128 through 45134) that included a new compliance date that
requires the use of ICD-10 beginning October 1, 2015. The August 4,
2014 final rule is available for viewing on the Internet at https://www.gpo.gov/fdsys/pkg/FR-2014-08-04/pdf/2014-18347.pdf. That final rule
also requires HIPAA covered entities to continue to use ICD-9-CM
through September 30, 2015. Thus, as we finalized in the FY 2015 SNF
PPS final rule, the effective date of the change from ICD-9-CM code 042
to ICD-10-CM code B20 for the purpose of applying the AIDS add-on
enacted by section 511 of the MMA is October 1, 2015.
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 payment rates set forth in this final rule reflect the
use of the RUG-IV case-mix classification system from October 1, 2015,
through September 30, 2016. We list the proposed case-mix adjusted RUG-
IV payment rates, provided separately for urban and rural SNFs, in
Tables 4 and 5 with corresponding case-mix values. We use the revised
OMB delineations adopted in the FY 2015 SNF PPS final rule (79 FR
45632, 45634) to identify a facility's urban or rural status for the
purpose of determining which set of rate tables apply to the facility.
These tables do not reflect the add-on for SNF residents with AIDS
enacted by section 511 of the MMA, which we apply only after making all
other adjustments (such as wage index and case-mix).
Table 4--RUG-IV Case-Mix Adjusted Federal Rates and Associated Indexes URBAN
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nursing Therapy Non-case mix Non-case mix
RUG-IV Category Nursing index Therapy index component component therapy comp component Total rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
RUX................................... 2.67 1.87 $457.02 $241.12 ............... $87.36 $785.50
RUL................................... 2.57 1.87 439.91 241.12 ............... 87.36 768.39
RVX................................... 2.61 1.28 446.75 165.04 ............... 87.36 699.15
RVL................................... 2.19 1.28 374.86 165.04 ............... 87.36 627.26
RHX................................... 2.55 0.85 436.48 109.60 ............... 87.36 633.44
RHL................................... 2.15 0.85 368.02 109.60 ............... 87.36 564.98
RMX................................... 2.47 0.55 422.79 70.92 ............... 87.36 581.07
RML................................... 2.19 0.55 374.86 70.92 ............... 87.36 533.14
RLX................................... 2.26 0.28 386.84 36.10 ............... 87.36 510.30
RUC................................... 1.56 1.87 267.03 241.12 ............... 87.36 595.51
RUB................................... 1.56 1.87 267.03 241.12 ............... 87.36 595.51
RUA................................... 0.99 1.87 169.46 241.12 ............... 87.36 497.94
RVC................................... 1.51 1.28 258.47 165.04 ............... 87.36 510.87
RVB................................... 1.11 1.28 190.00 165.04 ............... 87.36 442.40
RVA................................... 1.10 1.28 188.29 165.04 ............... 87.36 440.69
RHC................................... 1.45 0.85 248.20 109.60 ............... 87.36 445.16
RHB................................... 1.19 0.85 203.69 109.60 ............... 87.36 400.65
RHA................................... 0.91 0.85 155.76 109.60 ............... 87.36 352.72
RMC................................... 1.36 0.55 232.79 70.92 ............... 87.36 391.07
RMB................................... 1.22 0.55 208.83 70.92 ............... 87.36 367.11
RMA................................... 0.84 0.55 143.78 70.92 ............... 87.36 302.06
RLB................................... 1.50 0.28 256.76 36.10 ............... 87.36 380.22
RLA................................... 0.71 0.28 121.53 36.10 ............... 87.36 244.99
ES3................................... 3.58 .............. 612.79 .............. 16.98 87.36 717.13
ES2................................... 2.67 .............. 457.02 .............. 16.98 87.36 561.36
ES1................................... 2.32 .............. 397.11 .............. 16.98 87.36 501.45
HE2................................... 2.22 .............. 380.00 .............. 16.98 87.36 484.34
HE1................................... 1.74 .............. 297.84 .............. 16.98 87.36 402.18
HD2................................... 2.04 .............. 349.19 .............. 16.98 87.36 453.53
HD1................................... 1.60 .............. 273.87 .............. 16.98 87.36 378.21
HC2................................... 1.89 .............. 323.51 .............. 16.98 87.36 427.85
HC1................................... 1.48 .............. 253.33 .............. 16.98 87.36 357.67
HB2................................... 1.86 .............. 318.38 .............. 16.98 87.36 422.72
HB1................................... 1.46 .............. 249.91 .............. 16.98 87.36 354.25
LE2................................... 1.96 .............. 335.49 .............. 16.98 87.36 439.83
LE1................................... 1.54 .............. 263.60 .............. 16.98 87.36 367.94
LD2................................... 1.86 .............. 318.38 .............. 16.98 87.36 422.72
LD1................................... 1.46 .............. 249.91 .............. 16.98 87.36 354.25
LC2................................... 1.56 .............. 267.03 .............. 16.98 87.36 371.37
LC1................................... 1.22 .............. 208.83 .............. 16.98 87.36 313.17
LB2................................... 1.45 .............. 248.20 .............. 16.98 87.36 352.54
LB1................................... 1.14 .............. 195.13 .............. 16.98 87.36 299.47
[[Page 46399]]
CE2................................... 1.68 .............. 287.57 .............. 16.98 87.36 391.91
CE1................................... 1.50 .............. 256.76 .............. 16.98 87.36 361.10
CD2................................... 1.56 .............. 267.03 .............. 16.98 87.36 371.37
CD1................................... 1.38 .............. 236.21 .............. 16.98 87.36 340.55
CC2................................... 1.29 .............. 220.81 .............. 16.98 87.36 325.15
CC1................................... 1.15 .............. 196.85 .............. 16.98 87.36 301.19
CB2................................... 1.15 .............. 196.85 .............. 16.98 87.36 301.19
CB1................................... 1.02 .............. 174.59 .............. 16.98 87.36 278.93
CA2................................... 0.88 .............. 150.63 .............. 16.98 87.36 254.97
CA1................................... 0.78 .............. 133.51 .............. 16.98 87.36 237.85
BB2................................... 0.97 .............. 166.03 .............. 16.98 87.36 270.37
BB1................................... 0.90 .............. 154.05 .............. 16.98 87.36 258.39
BA2................................... 0.70 .............. 119.82 .............. 16.98 87.36 224.16
BA1................................... 0.64 .............. 109.55 .............. 16.98 87.36 213.89
PE2................................... 1.50 .............. 256.76 .............. 16.98 87.36 361.10
PE1................................... 1.40 .............. 239.64 .............. 16.98 87.36 343.98
PD2................................... 1.38 .............. 236.21 .............. 16.98 87.36 340.55
PD1................................... 1.28 .............. 219.10 .............. 16.98 87.36 323.44
PC2................................... 1.10 .............. 188.29 .............. 16.98 87.36 292.63
PC1................................... 1.02 .............. 174.59 .............. 16.98 87.36 278.93
PB2................................... 0.84 .............. 143.78 .............. 16.98 87.36 248.12
PB1................................... 0.78 .............. 133.51 .............. 16.98 87.36 237.85
PA2................................... 0.59 .............. 100.99 .............. 16.98 87.36 205.33
PA1................................... 0.54 .............. 92.43 .............. 16.98 87.36 196.77
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 5--RUG-IV Case-Mix Adjusted Federal Rates and Associated Indexes RURAL
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nursing Therapy Non-case mix Non-case mix
RUG-IV Category Nursing index Therapy index component component therapy comp component Total rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
RUX................................... 2.67 1.87 $436.63 $278.01 ............... $88.97 $803.61
RUL................................... 2.57 1.87 420.27 278.01 ............... 88.97 787.25
RVX................................... 2.61 1.28 426.81 190.30 ............... 88.97 706.08
RVL................................... 2.19 1.28 358.13 190.30 ............... 88.97 637.40
RHX................................... 2.55 0.85 417.00 126.37 ............... 88.97 632.34
RHL................................... 2.15 0.85 351.59 126.37 ............... 88.97 566.93
RMX................................... 2.47 0.55 403.92 81.77 ............... 88.97 574.66
RML................................... 2.19 0.55 358.13 81.77 ............... 88.97 528.87
RLX................................... 2.26 0.28 369.58 41.63 ............... 88.97 500.18
RUC................................... 1.56 1.87 255.11 278.01 ............... 88.97 622.09
RUB................................... 1.56 1.87 255.11 278.01 ............... 88.97 622.09
RUA................................... 0.99 1.87 161.89 278.01 ............... 88.97 528.87
RVC................................... 1.51 1.28 246.93 190.30 ............... 88.97 526.20
RVB................................... 1.11 1.28 181.52 190.30 ............... 88.97 460.79
RVA................................... 1.10 1.28 179.88 190.30 ............... 88.97 459.15
RHC................................... 1.45 0.85 237.12 126.37 ............... 88.97 452.46
RHB................................... 1.19 0.85 194.60 126.37 ............... 88.97 409.94
RHA................................... 0.91 0.85 148.81 126.37 ............... 88.97 364.15
RMC................................... 1.36 0.55 222.40 81.77 ............... 88.97 393.14
RMB................................... 1.22 0.55 199.51 81.77 ............... 88.97 370.25
RMA................................... 0.84 0.55 137.37 81.77 ............... 88.97 308.11
RLB................................... 1.50 0.28 245.30 41.63 ............... 88.97 375.90
RLA................................... 0.71 0.28 116.11 41.63 ............... 88.97 246.71
ES3................................... 3.58 .............. 585.44 .............. 18.14 88.97 692.55
ES2................................... 2.67 .............. 436.63 .............. 18.14 88.97 543.74
ES1................................... 2.32 .............. 379.39 .............. 18.14 88.97 486.50
HE2................................... 2.22 .............. 363.04 .............. 18.14 88.97 470.15
HE1................................... 1.74 .............. 284.54 .............. 18.14 88.97 391.65
HD2................................... 2.04 .............. 333.60 .............. 18.14 88.97 440.71
HD1................................... 1.60 .............. 261.65 .............. 18.14 88.97 368.76
HC2................................... 1.89 .............. 309.07 .............. 18.14 88.97 416.18
HC1................................... 1.48 .............. 242.02 .............. 18.14 88.97 349.13
HB2................................... 1.86 .............. 304.17 .............. 18.14 88.97 411.28
HB1................................... 1.46 .............. 238.75 .............. 18.14 88.97 345.86
LE2................................... 1.96 .............. 320.52 .............. 18.14 88.97 427.63
LE1................................... 1.54 .............. 251.84 .............. 18.14 88.97 358.95
LD2................................... 1.86 .............. 304.17 .............. 18.14 88.97 411.28
LD1................................... 1.46 .............. 238.75 .............. 18.14 88.97 345.86
LC2................................... 1.56 .............. 255.11 .............. 18.14 88.97 362.22
LC1................................... 1.22 .............. 199.51 .............. 18.14 88.97 306.62
[[Page 46400]]
LB2................................... 1.45 .............. 237.12 .............. 18.14 88.97 344.23
LB1................................... 1.14 .............. 186.42 .............. 18.14 88.97 293.53
CE2................................... 1.68 .............. 274.73 .............. 18.14 88.97 381.84
CE1................................... 1.50 .............. 245.30 .............. 18.14 88.97 352.41
CD2................................... 1.56 .............. 255.11 .............. 18.14 88.97 362.22
CD1................................... 1.38 .............. 225.67 .............. 18.14 88.97 332.78
CC2................................... 1.29 .............. 210.95 .............. 18.14 88.97 318.06
CC1................................... 1.15 .............. 188.06 .............. 18.14 88.97 295.17
CB2................................... 1.15 .............. 188.06 .............. 18.14 88.97 295.17
CB1................................... 1.02 .............. 166.80 .............. 18.14 88.97 273.91
CA2................................... 0.88 .............. 143.91 .............. 18.14 88.97 251.02
CA1................................... 0.78 .............. 127.55 .............. 18.14 88.97 234.66
BB2................................... 0.97 .............. 158.62 .............. 18.14 88.97 265.73
BB1................................... 0.90 .............. 147.18 .............. 18.14 88.97 254.29
BA2................................... 0.70 .............. 114.47 .............. 18.14 88.97 221.58
BA1................................... 0.64 .............. 104.66 .............. 18.14 88.97 211.77
PE2................................... 1.50 .............. 245.30 .............. 18.14 88.97 352.41
PE1................................... 1.40 .............. 228.94 .............. 18.14 88.97 336.05
PD2................................... 1.38 .............. 225.67 .............. 18.14 88.97 332.78
PD1................................... 1.28 .............. 209.32 .............. 18.14 88.97 316.43
PC2................................... 1.10 .............. 179.88 .............. 18.14 88.97 286.99
PC1................................... 1.02 .............. 166.80 .............. 18.14 88.97 273.91
PB2................................... 0.84 .............. 137.37 .............. 18.14 88.97 244.48
PB1................................... 0.78 .............. 127.55 .............. 18.14 88.97 234.66
PA2................................... 0.59 .............. 96.48 .............. 18.14 88.97 203.59
PA1................................... 0.54 .............. 88.31 .............. 18.14 88.97 195.42
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. 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 proposed to continue
this practice for FY 2016, 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. For FY 2016, the updated wage data are for hospital cost
reporting periods beginning on or after October 1, 2011 and before
October 1, 2012 (FY 2012 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)
authorized us to establish a geographic reclassification procedure that
is specific to SNFs, but only after collecting the data necessary to
establish a SNF 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.
In addition, we proposed 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 FY 2016 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 2016, there are no rural geographic areas that do not have
hospitals, and thus, this methodology will not be applied. For rural
Puerto Rico, we will 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 will continue to use the most recent wage index previously
available for that area. For urban areas without specific hospital wage
index data, we will 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 2016, the only urban area without wage
index data available is CBSA 25980, Hinesville-Fort Stewart, GA. The
wage index applicable to FY 2016 is set forth in Table A available on
the CMS Web site at https://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
Once calculated, we will 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 2014 (78 FR 47944 through
47946), we finalized a proposal to revise the labor-related share to
reflect the relative importance of the revised FY 2010-based SNF market
basket cost weights for the following cost categories: Wages and
salaries; employee benefits; the labor-related portion of nonmedical
professional fees; administrative and facilities support services; all
other:
[[Page 46401]]
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 2016. 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 2016 than the base year weights
from the SNF market basket.
We calculate the labor-related relative importance for FY 2016 in
four steps. First, we compute the FY 2016 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
2016 price index level for that cost category by the total market
basket price index level. Third, we determine the FY 2016 relative
importance for each cost category by multiplying this ratio by the base
year (FY 2010) weight. Finally, we add the FY 2016 relative importance
for each of the labor-related cost categories (wages and salaries,
employee benefits, the labor-related portion of non-medical
professional fees, administrative and facilities support services, all
other: labor-related services, and a portion of capital-related
expenses) to produce the FY 2016 labor-related relative importance.
Table 6 summarizes the updated labor-related share for FY 2016,
compared to the labor-related share that was used for the FY 2015 SNF
PPS final rule.
We proposed for FY 2016 and subsequent FYs, to report and apply the
SNF PPS labor-related share at a tenth of a percentage point (rather
than at a thousandth of a percentage point) consistent with the manner
in which we report and apply the market basket update percentage under
the SNF PPS and the IPPS and the manner in which we report and apply
the IPPS labor-related share. The level of precision specified for the
IPPS labor-related share is three decimal places or a tenth of a
percentage point (0.696 or 69.6 percent), which we believe provides a
reasonable level of precision. We believe it is appropriate to maintain
such consistency across all payment systems so that the level of
precision specified is both reasonable and similar for all providers.
Additionally, we proposed in the FY 2016 SNF PPS proposed rule (80 FR
22049) that if more recent data become available (for example, a more
recent estimate of the FY 2010-based SNF market basket and/or MFP
adjustment), we would use such data, if appropriate, to determine the
FY 2016 SNF market basket percentage change, labor-related share
relative importance, forecast error adjustment, and MFP adjustment in
this final rule. We note that more recent data did become available and
that the proposed labor related share for FY 2016 of 69.2 percent has
been updated, based on IGI's second quarter 2015 forecast, to an FY
2016 labor related share of 69.1 percent.
We invited public comments on these proposals. A discussion of the
comments we received on these proposals, as well as a discussion of the
general comments that we received on the wage index adjustment, and our
responses to those comments, appears below.
Comment: Several commenters stated that hospital cost data may not
be the most reliable resource when determining geographical differences
in salary structure for SNFs. These commenters urged CMS to establish a
SNF-specific wage index. One commenter stated that new SNF cost
reports, required by section 6104 of the Affordable Care Act, provide
the requisite data in order for CMS to establish a SNF-specific wage
index that could replace the current use of the inpatient hospital wage
index data as the basis for the current SNF wage index.
Response: We appreciate the commenters raising these concerns,
particularly the one commenter who provided significant details on how
new SNF cost-report data could be used to develop a SNF-specific wage
index. While CMS may consider this new data source as a potential
stepping-stone towards developing a SNF-specific wage index, we note
that consistent with our previous responses to these recurring comments
(most recently published in the FY 2015 SNF PPS final rule (79 FR
45636)), developing such a wage index would require a resource-
intensive audit process similar to that used for IPPS hospital data, to
improve the quality of the SNF cost report data in order for it to be
used as part of this analysis. Ultimately, while we continue to review
all available data and contemplate the potential methodological
approaches for a SNF-specific wage index in the future, we do not
believe that the current state of the data is sufficiently refined to
permit any such use of this data at this time.
Comment: Some commenters urged that CMS, to the extent that we plan
to continue to use hospital cost data as the basis for SNF wage index
adjustments, consider adopting certain wage index policies in use under
the IPPS, such as reclassification or rural floor, because SNFs compete
in a similar labor pool as acute care hospitals. Commenters also stated
that CMS should use post-reclassification hospital wage data to
influence SNF PPS wage index policy decisions. These commenters further
stated that in addition to considering such policies as
reclassification and a rural floor, CMS should consider implementing a
floor and ceiling for annual changes to the wage index in order to
smooth perceived volatility of such changes.
Response: Consistent with our previous responses to these recurring
comments (most recently published in the FY 2015 SNF PPS final rule (79
FR 45636 through 45637), we continue to believe that in the absence of
the appropriate SNF-specific wage data, using the pre-reclassified
hospital inpatient wage data (without the occupational mix adjustment)
is appropriate and reasonable for the SNF PPS. As discussed above,
section 315 of BIPA authorized us to establish a geographic
reclassification procedure that is specific to SNFs, only after
collecting the data necessary to establish a SNF-specific wage index
that is based on data from nursing homes. However, to date this has
been infeasible 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. Furthermore, we do not believe that using
hospital reclassification data would be appropriate as this data is
specific to the requesting hospitals and it may or may not apply to a
given SNF in a given instance. With regard to implementing a rural
floor, we do not believe it would be prudent at this time to adopt such
a policy, because MedPAC has recommended eliminating the rural floor
policy from the calculation of the IPPS wage index (see, for example,
Chapter 3 of MedPAC's March 2013 Report to Congress on Medicare Payment
Policy, available at https://medpac.gov/documents/reports/mar13_entirereport.pdf, which notes on page 65 that in 2007, MedPAC had
``. . . recommended eliminating these special wage index adjustments
and adopting a new wage index system to avoid geographic inequities
that can occur due to current wage index policies (Medicare Payment
Advisory Commission 2007b.'') If we adopted the rural floor at this
time under the SNF PPS, we believe that, the SNF PPS wage index could
become vulnerable to
[[Page 46402]]
problems similar to those that MedPAC identified in its March 2013
Report to Congress. Additionally, at this time, we do not believe it
would be appropriate to establish a floor and ceiling for annual wage
index changes. Any perceived volatility in the wage index is predicated
upon volatility in actual wages in that area and reflects real
differences in area wage levels that should be accounted for timely. As
stated above, under 1888(e)(4)(G)(ii) of the Act and Sec.
413.337(a)(1)(ii) of the regulations, we adjust the SNF PPS rates to
account for differences in area wage levels. We believe that applying a
ceiling or floor to annual wage index changes would make the wage index
for a given area less reflective of the area wage levels and changes.
Additionally, we note that establishing an artificial ceiling for
annual changes in the wage index could not only result in an inaccurate
wage index, but also potentially have an adverse impact on those
providers that would otherwise experience a larger increase in their
wage index absent such a ceiling.
Comment: One commenter requested that CMS provide more detail on
the processes and procedures that are used in determining what hospital
data may be excluded from forming the inpatient hospital wage index,
which serves as the basis for the SNF wage index.
Response: The processes and procedures for how the inpatient
hospital wage index is developed are discussed in the Inpatient
Prospective Payment System (IPPS) rule each year, with the most recent
discussion appearing in the FY 2016 IPPS proposed rule (80 FR 24463
through 24477) and subsequent FY 2016 IPPS final rule.
After considering the comments received and for the reasons
discussed above and in the FY 2016 SNF PPS proposed rule (80 FR 22052
through 22056), we are finalizing the FY 2016 wage index adjustment and
related policies as proposed in the FY 2016 SNF PPS proposed rule
without modification. For FY 2016, the updated wage data are for
hospital cost reporting periods beginning on or after October 1, 2011
and before October 1, 2012 (FY 2012 cost report data). We are also
finalizing our proposal that for FY 2016 and subsequent FYs, we will
report and apply the SNF PPS labor-related share at a tenth of a
percentage point (rather than at a thousandth of a percentage point)
consistent with the manner in which we report and apply the market
basket update percentage under the SNF PPS and the IPPS and the manner
in which we report and apply the IPPS labor-related share. Table 6
summarizes the updated labor-related share for FY 2016, compared to the
labor-related share that was used for the FY 2015 SNF PPS final rule.
Table 6--Labor-Related Relative Importance, FY 2015 and FY 2016
----------------------------------------------------------------------------------------------------------------
Relative importance, Relative importance,
labor-related, FY 2015 labor-related, FY 2016
14:2 forecast \1\ 15:2 forecast \2\
----------------------------------------------------------------------------------------------------------------
Wages and salaries............................................ 48.816 48.8
Employee benefits............................................. 11.365 11.3
Nonmedical Professional fees: labor-related................... 3.450 3.5
Administrative and facilities support services................ 0.502 0.5
All Other: Labor-related services............................. 2.276 2.3
Capital-related (.391)........................................ 2.771 2.7
-------------------------------------------------
Total..................................................... 69.180 69.1
----------------------------------------------------------------------------------------------------------------
\1\ Published in the Federal Register; based on second quarter 2014 IGI forecast
\2\ Based on second quarter 2015 IGI forecast, with historical data through first quarter 2015.
Tables 7 and 8 show the RUG-IV case-mix adjusted federal rates by
labor-related and non-labor-related components.
Table 7--RUG-IV Case-Mix Adjusted Federal Rates for Urban SNFs by Labor and Non-Labor Component
----------------------------------------------------------------------------------------------------------------
RUG-IV Category Total rate Labor portion Non-labor portion
----------------------------------------------------------------------------------------------------------------
RUX.................................. 785.50................. $542.78 $242.72
RUL.................................. 768.39................. 530.96 237.43
RVX.................................. 699.15................. 483.11 216.04
RVL.................................. 627.26................. 433.44 193.82
RHX.................................. 633.44................. 437.71 195.73
RHL.................................. 564.98................. 390.40 174.58
RMX.................................. 581.07................. 401.52 179.55
RML.................................. 533.14................. 368.40 164.74
RLX.................................. 510.30................. 352.62 157.68
RUC.................................. 595.51................. 411.50 184.01
RUB.................................. 595.51................. 411.50 184.01
RUA.................................. 497.94................. 344.08 153.86
RVC.................................. 510.87................. 353.01 157.86
RVB.................................. 442.40................. 305.70 136.70
RVA.................................. 440.69................. 304.52 136.17
RHC.................................. 445.16................. 307.61 137.55
RHB.................................. 400.65................. 276.85 123.80
RHA.................................. 352.72................. 243.73 108.99
RMC.................................. 391.07................. 270.23 120.84
RMB.................................. 367.11................. 253.67 113.44
RMA.................................. 302.06................. 208.72 93.34
RLB.................................. 380.22................. 262.73 117.49
[[Page 46403]]
RLA.................................. 244.99................. 169.29 75.70
ES3.................................. 717.13................. 495.54 221.59
ES2.................................. 561.36................. 387.90 173.46
ES1.................................. 501.45................. 346.50 154.95
HE2.................................. 484.34................. 334.68 149.66
HE1.................................. 402.18................. 277.91 124.27
HD2.................................. 453.53................. 313.39 140.14
HD1.................................. 378.21................. 261.34 116.87
HC2.................................. 427.85................. 295.64 132.21
HC1.................................. 357.67................. 247.15 110.52
HB2.................................. 422.72................. 292.10 130.62
HB1.................................. 354.25................. 244.79 109.46
LE2.................................. 439.83................. 303.92 135.91
LE1.................................. 367.94................. 254.25 113.69
LD2.................................. 422.72................. 292.10 130.62
LD1.................................. 354.25................. 244.79 109.46
LC2.................................. 371.37................. 256.62 114.75
LC1.................................. 313.17................. 216.40 96.77
LB2.................................. 352.54................. 243.61 108.93
LB1.................................. 299.47................. 206.93 92.54
CE2.................................. 391.91................. 270.81 121.10
CE1.................................. 361.10................. 249.52 111.58
CD2.................................. 371.37................. 256.62 114.75
CD1.................................. 340.55................. 235.32 105.23
CC2.................................. 325.15................. 224.68 100.47
CC1.................................. 301.19................. 208.12 93.07
CB2.................................. 301.19................. 208.12 93.07
CB1.................................. 278.93................. 192.74 86.19
CA2.................................. 254.97................. 176.18 78.79
CA1.................................. 237.85................. 164.35 73.50
BB2.................................. 270.37................. 186.83 83.54
BB1.................................. 258.39................. 178.55 79.84
BA2.................................. 224.16................. 154.89 69.27
BA1.................................. 213.89................. 147.80 66.09
PE2.................................. 361.10................. 249.52 111.58
PE1.................................. 343.98................. 237.69 106.29
PD2.................................. 340.55................. 235.32 105.23
PD1.................................. 323.44................. 223.50 99.94
PC2.................................. 292.63................. 202.21 90.42
PC1.................................. 278.93................. 192.74 86.19
PB2.................................. 248.12................. 171.45 76.67
PB1.................................. 237.85................. 164.35 73.50
PA2.................................. 205.33................. 141.88 63.45
PA1.................................. 196.77................. 135.97 60.80
----------------------------------------------------------------------------------------------------------------
Table 8--RUG-IV Case-Mix Adjusted Federal Rates for Rural SNFs by Labor and Non-Labor Component
----------------------------------------------------------------------------------------------------------------
RUG-IV category Total rate Labor portion Non-labor portion
----------------------------------------------------------------------------------------------------------------
RUX.................................. 803.61................. $555.29 $248.32
RUL.................................. 787.25................. 543.99 243.26
RVX.................................. 706.08................. 487.90 218.18
RVL.................................. 637.40................. 440.44 196.96
RHX.................................. 632.34................. 436.95 195.39
RHL.................................. 566.93................. 391.75 175.18
RMX.................................. 574.66................. 397.09 177.57
RML.................................. 528.87................. 365.45 163.42
RLX.................................. 500.18................. 345.62 154.56
RUC.................................. 622.09................. 429.86 192.23
RUB.................................. 622.09................. 429.86 192.23
RUA.................................. 528.87................. 365.45 163.42
RVC.................................. 526.20................. 363.60 162.60
RVB.................................. 460.79................. 318.41 142.38
RVA.................................. 459.15................. 317.27 141.88
RHC.................................. 452.46................. 312.65 139.81
RHB.................................. 409.94................. 283.27 126.67
RHA.................................. 364.15................. 251.63 112.52
RMC.................................. 393.14................. 271.66 121.48
RMB.................................. 370.25................. 255.84 114.41
RMA.................................. 308.11................. 212.90 95.21
[[Page 46404]]
RLB.................................. 375.90................. 259.75 116.15
RLA.................................. 246.71................. 170.48 76.23
ES3.................................. 692.55................. 478.55 214.00
ES2.................................. 543.74................. 375.72 168.02
ES1.................................. 486.50................. 336.17 150.33
HE2.................................. 470.15................. 324.87 145.28
HE1.................................. 391.65................. 270.63 121.02
HD2.................................. 440.71................. 304.53 136.18
HD1.................................. 368.76................. 254.81 113.95
HC2.................................. 416.18................. 287.58 128.60
HC1.................................. 349.13................. 241.25 107.88
HB2.................................. 411.28................. 284.19 127.09
HB1.................................. 345.86................. 238.99 106.87
LE2.................................. 427.63................. 295.49 132.14
LE1.................................. 358.95................. 248.03 110.92
LD2.................................. 411.28................. 284.19 127.09
LD1.................................. 345.86................. 238.99 106.87
LC2.................................. 362.22................. 250.29 111.93
LC1.................................. 306.62................. 211.87 94.75
LB2.................................. 344.23................. 237.86 106.37
LB1.................................. 293.53................. 202.83 90.70
CE2.................................. 381.84................. 263.85 117.99
CE1.................................. 352.41................. 243.52 108.89
CD2.................................. 362.22................. 250.29 111.93
CD1.................................. 332.78................. 229.95 102.83
CC2.................................. 318.06................. 219.78 98.28
CC1.................................. 295.17................. 203.96 91.21
CB2.................................. 295.17................. 203.96 91.21
CB1.................................. 273.91................. 189.27 84.64
CA2.................................. 251.02................. 173.45 77.57
CA1.................................. 234.66................. 162.15 72.51
BB2.................................. 265.73................. 183.62 82.11
BB1.................................. 254.29................. 175.71 78.58
BA2.................................. 221.58................. 153.11 68.47
BA1.................................. 211.77................. 146.33 65.44
PE2.................................. 352.41................. 243.52 108.89
PE1.................................. 336.05................. 232.21 103.84
PD2.................................. 332.78................. 229.95 102.83
PD1.................................. 316.43................. 218.65 97.78
PC2.................................. 286.99................. 198.31 88.68
PC1.................................. 273.91................. 189.27 84.64
PB2.................................. 244.48................. 168.94 75.54
PB1.................................. 234.66................. 162.15 72.51
PA2.................................. 203.59................. 140.68 62.91
PA1.................................. 195.42................. 135.04 60.38
----------------------------------------------------------------------------------------------------------------
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 2016 (federal rates
effective October 1, 2015), we will apply an adjustment to fulfill the
budget neutrality requirement. We 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 2015 to the weighted average wage adjustment
factor for FY 2016. For this calculation, we use the same FY 2014
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 budget neutrality factor
for FY 2016 would be 0.9992.
In the SNF PPS final rule for FY 2006 (70 FR 45026, August 4,
2005), we adopted the changes discussed in the OMB Bulletin No. 03-04
(June 6, 2003), available online at www.whitehouse.gov/omb/bulletins/b03-04.html, 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.
On February 28, 2013, OMB issued OMB Bulletin No. 13-01, announcing
revisions to the delineation of MSAs, Micropolitan Statistical Areas,
and Combined Statistical Areas, and guidance on uses of the delineation
of
[[Page 46405]]
these areas. This bulletin, which is available online at https://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf,
provides the delineations of all Metropolitan Statistical Areas,
Metropolitan Divisions, Micropolitan Statistical Areas, Combined
Statistical Areas, and New England City and Town Areas in the United
States and Puerto Rico based on the standards published on June 28,
2010, in the Federal Register (75 FR 37246 through 37252) and Census
Bureau data.
While the revisions OMB published on February 28, 2013 are not as
sweeping as the changes made when we adopted the CBSA geographic
designations for FY 2006, the February 28, 2013 bulletin does contain a
number of significant changes. For example, there are new CBSAs, urban
counties that became rural, rural counties that became urban, and
existing CBSAs that were split apart.
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. Because the 1-year transition period expires at the end of FY
2015, the SNF PPS wage index for FY 2016 is fully based on the revised
OMB delineations adopted in FY 2015. As noted in this section, the wage
index applicable to FY 2016 is set forth in Table A available on the
CMS Web site at https://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
5. Adjusted Rate Computation Example
Using the hypothetical SNF XYZ described below, Table 9 shows the
adjustments made to the federal per diem rates to compute the
provider's actual per diem PPS payment. We derive the Labor and Non-
labor columns from Table 7. The wage index used in this example is
based on the wage index found in Table A as referenced in this section.
As illustrated in Table 9, SNF XYZ's total PPS payment would equal
$45,256.24.
Table 9--Adjusted Rate Computation Example SNF XYZ: Located in Frederick, MD (Urban CBSA 43524) Wage Index: 0.9640
[See wage index in table A] \1\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Percent
RUG-IV Group Labor Wage index Adjusted labor Non-labor Adjusted rate adjustment Medicare days Payment
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
RVX............................................................. $483.11 0.9640 $465.72 $216.04 $681.76 $681.76 14 $9,544.64
ES2............................................................. 387.90 0.9640 373.94 173.46 547.40 547.40 30 16,422.00
RHA............................................................. 243.73 0.9640 234.96 108.99 343.95 343.95 16 5,503.20
CC2 *........................................................... 224.68 0.9640 216.59 100.47 317.06 722.90 10 7,229.00
BA2............................................................. 154.89 0.9640 149.31 69.27 218.58 218.58 30 6,557.40
.............. .............. .............. .............. .............. .............. 100 45,256.24
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* Reflects a 128 percent adjustment from section 511 of the MMA.
\1\ Available on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
C. Additional Aspects of the SNF PPS
1. 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.B.3 of this final rule. This approach includes an
administrative presumption that utilizes a beneficiary's initial
classification in one of the upper 52 RUGs of the 66-group RUG-IV case-
mix classification system to assist in making certain SNF level of care
determinations.
In accordance with section 1888(e)(4)(H)(ii) of the Act and the
regulations at Sec. 413.345, we include in each update of the federal
payment rates in the Federal Register the designation of those specific
RUGs under the classification system that represent the required SNF
level of care, as provided in Sec. 409.30. As set forth in the FY 2011
SNF PPS update notice (75 FR 42910), this designation reflects an
administrative presumption under the 66-group RUG-IV system that
beneficiaries who are correctly assigned to one of the upper 52 RUG-IV
groups on the initial 5-day, Medicare-required assessment are
automatically classified as meeting the SNF level of care definition up
to and including the assessment reference date on the five-day
Medicare-required assessment.
A beneficiary assigned to any of the lower 14 RUG-IV groups is not
automatically classified as either meeting or not meeting the
definition, but instead receives an individual level of care
determination using the existing administrative criteria. This
presumption recognizes the strong likelihood that beneficiaries
assigned to one of the upper 52 RUG-IV groups during the immediate
post-hospital period require a covered level of care, which would be
less likely for those beneficiaries assigned to one of the lower 14
RUG-IV groups.
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. In this final rule, we will continue to designate the upper
52 RUG-IV groups for purposes of this administrative presumption,
consisting of all groups encompassed by the following RUG-IV
categories:
Rehabilitation plus Extensive Services.
Ultra High Rehabilitation.
Very High Rehabilitation.
High Rehabilitation.
Medium Rehabilitation.
Low Rehabilitation.
Extensive Services.
Special Care High.
Special Care Low.
Clinically Complex.
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 the services prompting the beneficiary's
assignment to one of the upper 52 RUG-IV groups (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
[[Page 46406]]
the Act). Accordingly, the presumption would not apply, for example,
in those situations in which a resident's assignment to one of the
upper . . . groups is itself based on 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 assessment reference date of the
5-day assessment.
We received one comment on this issue, which we discuss below along
with our response.
Comment: One commenter requested that CMS consider further analysis
of the administrative presumption that utilizes a beneficiary's initial
classification in one of the upper 52 RUGs to assist in making certain
SNF level of care determinations. The commenter expressed concern that
the use of such presumptions could disadvantage members of certain
vulnerable specialty populations who might not typically group to one
of the upper 52 RUGs, and yet still require a sufficient intensity of
services to qualify for coverage.
Response: While it is true that those SNF residents who group to
one of the lower 14 RUGs on the initial 5-day, Medicare-required
assessment are not automatically presumed to require a skilled level of
care, neither are they automatically classified as requiring nonskilled
care. Instead, as we have noted in this and previous SNF PPS rules, any
such resident ``. . . receives an individual level of care
determination using the existing administrative criteria.'' We adopted
this approach specifically to ensure that the presumption does not
disadvantage such residents, by providing them with an individualized
level of care determination that fully considers all pertinent factors.
Nevertheless, as we noted previously in the FY 2000 SNF PPS final rule
(64 FR 41668, July 30, 1999), while we believe that the use of the
administrative level of care presumption ``. . . represents a
significant advancement toward achieving greater simplicity,
predictability, and consistency in the coverage process, we will
continue to monitor coverage determinations under the SNF PPS with a
view toward the possibility of making further refinements and
improvements in the future.'' Accordingly, we will keep the commenter's
concerns in mind as we continue our ongoing SNF PPS research and
analysis.
2. Consolidated Billing
Sections 1842(b)(6)(E) and 1862(a)(18) of the Act (as added by
section 4432(b) of the BBA) require a SNF to submit consolidated
Medicare bills to its Medicare Administrative Contractor 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 Web site at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Legislative_History_07302013.pdf. In particular, section 103
of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999 (BBRA, Pub. L. 106-113) 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 discussed 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 19231 through
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 prospective payment system. . . .'' According to the conferees,
section 103(a) of the BBRA ``is an attempt to exclude from the PPS
certain services and costly items that are provided infrequently in
SNFs. . . .'' By contrast, we noted that the Congress declined to
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 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), and since
that time, we have periodically invited the public to submit comments
identifying codes that might meet the criteria for exclusion. In the FY
2016 SNF PPS proposed rule (80 FR 22057-58), we specifically invited
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, and we requested
[[Page 46407]]
commenters to 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. A
discussion of the public comments received on this topic, along with
our responses, appears below.
Comment: One commenter recommended a new chemotherapy drug,
BLINCYTO[supreg], as meeting the statutory ``high-cost, low
probability'' criteria for exclusion from consolidated billing. After
noting that this drug currently is assigned a temporary C code, C9449
(Injection, blinatumomab, 1 mcg.), the commenter referred to our
explanation in the FY 2015 SNF PPS final rule that ``. . . a
chemotherapy drug's assignment to its own specific code has always
served as the mechanism of designating that drug for exclusion, as well
as the means by which the claims processing system is able to recognize
that exclusion'' (79 FR 45642, August 5, 2014). The commenter then
suggested that until such time as this drug may be assigned a permanent
J code of its own, CMS should devise an administrative alternative for
effectuating its exclusion from consolidated billing, such as utilizing
the drug's existing C code for this purpose. The commenter further
stated that the exclusion list's current use of C codes for designating
the excluded magnetic resonance imaging (MRI) services in Major
Category I.C establishes the feasibility of similarly adopting such an
approach for chemotherapy drugs like BLINCYTO[supreg] under Major
Category III.A.
Response: We agree with the commenter that, as described, this drug
would appear to meet the ``high-cost, low probability'' criteria to
qualify for the statutory carve-out of certain highly intensive
chemotherapy drugs from consolidated billing. We note that, as
described in the National Institutes of Health's MedlinePlus Web site
at www.nlm.nih.gov/medlineplus/druginfo/meds/a614061.html, this is one
of the types of drugs referenced in the BBRA Conference Report's
legislative history on the chemotherapy exclusion (H.R. Rep. No. 106-
479 at 854 (1999) (Conf. Rep.)); namely, those chemotherapy drugs that
``. . . are given as infusions, thus requiring special staff expertise
to administer.'' In addition, the comment itself notes that ``In the
six months since BLINCYTO[supreg] has been approved and available on
the market, we are not aware of any patients who were treated with
BLINCYTO[supreg] in the SNF setting'' (emphasis added). However, we are
unable to adopt the commenter's suggestion that until a specific J code
is assigned, a C code appropriately could be used on an interim basis
as a vehicle for designating a chemotherapy drug for exclusion from
consolidated billing. While the commenter is correct in pointing out
some excluded MRI services that are identified by C code, we note that
these C codes are designed specifically for use under the outpatient
hospital PPS (OPPS), and that in contrast to the administrative
exclusion for MRIs--which is a hospital-specific exclusion--the
statutory chemotherapy exclusion is a categorical one that applies
equally to hospital and non-hospital settings alike. This means that a
temporary C code would not be suitable for the purpose of excluding
chemotherapy drugs from consolidated billing and that, as we indicated
previously in the FY 2015 SNF PPS final rule, we are unable to
designate a chemotherapy drug for exclusion from consolidated billing
prior to the point at which it is actually assigned its own permanent J
code. Accordingly, we plan to add this drug to the exclusion list, at
such time as it may be assigned a specific J code of its own.
Comment: Several commenters expressed their continued support for
the longstanding statutory exclusion from consolidated billing of
certain specified types of customized prosthetic devices, and
recommended the exclusion of two additional prosthetic device codes,
L5969 (``ankle/foot power assist, including motors'') and L5987 (``all
lower extremity prosthesis, shank foot system with vertical loading
pylon''). One commenter further recommended that certain customized
orthotic devices meeting the statutory ``high-cost, low probability''
criteria be excluded as well.
Response: We note that code L5969 actually appears on the exclusion
list already under Major Category III.D (``Customized Prosthetic
Devices''), where this particular L code has, in fact, been listed ever
since its initial assignment in January 2014. Regarding code L5987, we
note that this particular code had been recommended for exclusion
previously during the FY 2012 rulemaking cycle, along with two other L
codes that, like L5987, already existed--but were not designated by the
Congress for exclusion--upon the original 1999 enactment of the
customized prosthetic device exclusion in the BBRA. In the FY 2012 SNF
PPS final rule (76 FR 48531, August 8, 2011), we issued our decision to
``. . . decline to add these codes to the exclusion list,'' explaining
that
. . . our position has always been that the BBRA's discretionary
authority to exclude codes within certain designated service
categories applies solely to codes that were created subsequent to
the BBRA's enactment, and not to those codes that were already in
existence as of July 1, 1999 (the date that the legislation itself
uses as the reference point for identifying the codes that it
designates for exclusion). As we explained in the FY 2010 final rule
(74 FR 40354), this position reflects the assumption that if a
particular code was already in existence as of that date but not
designated for exclusion, this meant that it was intended to remain
within the SNF PPS bundle, subject to the BBRA Conference Report's
provision for a GAO review of the code set that was conducted the
following year (H.R. Rep. No. 106-479 at 854 (1999) (Conf. Rep.)).
Regarding the suggestion on excluding certain customized orthotic
devices under this authority, we have explained repeatedly in this and
previous rules that the amendments enacted in section 103 of the BBRA
only allow us to identify additional codes for exclusion within each of
the four specified service categories: chemotherapy items, chemotherapy
administration services, radioisotope services, and customized
prosthetic devices (a category that is separate from and does not
encompass orthotics). Accordingly, as we have already indicated
previously in the SNF PPS final rules for FY 2001 (65 FR 46790, July
31, 2000) and FY 2009 (73 FR 46436, August 8, 2008), because orthotic
devices do not fall within any of these four specified service
categories, excluding them from consolidated billing would require
legislation by the Congress to amend the law.
Comment: Several commenters on the VBP provision additionally
alleged that there is an inherent ``tension'' between VBP and
consolidated billing (the SNF PPS's bundling requirement), particularly
with respect to portable x-rays and other types of diagnostic imaging,
services that the commenters characterized as playing a key role in
providing high-quality patient care. The commenters stated that the
inclusion of these services within the PPS bundle incentivizes SNFs to
select suppliers of diagnostic services solely on the basis of price,
without considering the quality of the services. They also stated that
the current framework allows a practice in which a supplier offers to
furnish deeply discounted services to the SNF's Part A residents in
return for being selected to handle the Part B services for those of
the SNF's Medicare-eligible residents who are in noncovered stays. The
commenters recommended that diagnostic imaging services should be
unbundled altogether (or, alternatively,
[[Page 46408]]
if left within the bundle, that the SNF should be required to pay its
supplier the full Part B fee schedule amount for them). They suggested
that unbundling these services would enable SNFs to focus more on the
quality of the services themselves rather than on the details of the
billing process. Some of the commenters additionally noted that certain
diagnostic radiology services such as portable x-rays are split between
a bundled technical component (TC, representing the diagnostic test
itself) and a separately billable professional component (PC,
representing the physician's interpretation of the test), and they
asserted that the portable x-ray's transportation and setup should
appropriately be classified under the separately billable PC rather
than the bundled TC, stating that the assignment of a Level II HCPCS
code is sufficient in itself to identify a service as being an excluded
``physician'' service in this context.
Response: We have long recognized the incentives to realize
efficiencies in providing care that are inherent in any bundled payment
requirement, along with the attendant concerns about the potential
effect of those incentives on quality of care. However, we do not
believe that the commenters, in citing the SNF VBP as a new basis for
reiterating these recurring concerns, have established sufficient
justification for unbundling diagnostic imaging services from
consolidated billing--an action that, in any event, would require
legislation by the Congress. We also note that the long-term care
facility requirements for participation, which long predate the VBP
legislation, contain at 42 CFR 483.25 an overall mandate for Medicare
SNFs to provide ``. . . the necessary care and services to attain or
maintain [each resident's] highest practicable physical, mental, and
psychosocial well-being, in accordance with the comprehensive
assessment and plan of care.'' In addition, whenever a SNF elects to
obtain such services from an outside source, the requirements at Sec.
483.75(h)(2)(i) further confer on the SNF the specific responsibility
to obtain ``. . . services that meet professional standards and
principles that apply to professionals providing services in such a
facility.'' Thus, a SNF that fails to provide the appropriate quantity
or quality of care in accordance with this mandate would jeopardize its
compliance with the requirements for participation in the Medicare
program.
Moreover, we do not accept the commenters' premise that placing the
billing responsibility with the SNF itself has the effect of
distracting from a focus on quality of care. To the contrary, the
consolidated billing provision was itself established precisely to help
promote the overall coordination of high-quality care in the SNF
setting. We note that prior to the enactment of this provision, care
for SNF residents could be fragmented among a wide variety of outside
suppliers who were not required to bill through the SNF. The resulting
dispersal of responsibility for resident care among various outside
suppliers adversely affected quality (coordination of care) and program
integrity, as documented in reports by both the Office of the Inspector
General (OIG) and the Government Accountability Office (GAO) (see OIG
report no. OEI-06-92-00863, ``Medicare Services Provided to Residents
of Skilled Nursing Facilities'' (October 1994), available online at
https://oig.hhs.gov/oei/reports/oei-06-92-00863.pdf, and GAO report no.
HEHS-96-18, ``Providers Target Medicare Patients in Nursing
Facilities'' (January 1996), available online at https://www.gao.gov/products/HEHS-96-18). Thus, the enactment of consolidated billing
reflected a recognition that fully enabling SNFs to ensure the overall
quality of their residents' services necessitated placing with the SNF
itself not only the professional but also the financial responsibility
for those services.
As for the commenters' suggestions on requiring SNFs to pay
suppliers the full Part B fee schedule amount for a bundled service, in
the FY 2000 SNF PPS final rule (64 FR 41677, July 30, 1999), we noted
in response to previous, similar suggestions that
. . . under current law, an SNF's relationship with its supplier is
essentially a private contractual matter, and the terms of the
supplier's payment by the SNF must be arrived at through direct
negotiations between the two parties themselves. Accordingly, we
believe that the most effective way for a supplier to address any
concerns that it may have about the adequacy or timeliness of the
SNF's payment would be for the supplier to ensure that any terms to
which it agrees in such negotiations satisfactorily address those
concerns.
In that same final rule (64 FR 41677), we also noted in response to
previous, similar concerns regarding supplier discounts that
. . . our discussion of the relationship between an SNF and its
suppliers should not be construed as addressing in any manner the
potential applicability of the statutory anti-kickback provisions,
since matters relating specifically to the enforcement of these
provisions lie exclusively within the purview of the Office of the
Inspector General.
Finally, we do not share the view of those commenters who would
categorize a portable x-ray service's transportation and setup as part
of the separately billable PC; rather, as noted in Sec. 90.5 of the
Medicare Claims Processing Manual, Chapter 13 (available online at
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c13.pdf):
. . . When a SNF resident receives a portable x-ray service during
the course of a Medicare-covered stay in the SNF, only the service's
professional component (representing the physician's interpretation
of the test results) is a separately billable physician service
under Part B . . . By contrast, the technical component representing
the procedure itself, including any associated transportation and
setup costs, would be subject to consolidated billing (the SNF
``bundling'' requirement for services furnished to the SNF's Part A
residents), and must be included on the SNF's Part A bill for the
resident's covered stay (Bill Type 21x) rather than being billed
separately under Part B . . . (emphasis added).
Moreover, notwithstanding the commenters' assertions, the
assignment of a Level II HCPCS code to a particular service would in no
way automatically equate to identifying it as an excluded ``physician''
service in this context. Rather, under the regulations at 42 CFR
411.15(p)(2)(i), the only services that can qualify for the physician
service exclusion from consolidated billing are those that meet the
criteria set forth in 42 CFR 415.102(a) for payment on a fee schedule
basis as a physician service. Sections 415.102(a)(1) and (a)(3), in
turn, specify that such a service must be furnished personally by a
physician, and must be a type of service that ordinarily requires such
performance. These are criteria that a portable x-ray service's
transportation and setup would never meet, as the service's excluded PC
relates solely to reading the x-ray rather than taking it, and the
physician's personal performance clearly would not be required for
activities such as driving the supplier's vehicle to the SNF, or
setting up the equipment once it arrives there.
3. 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, these
services furnished by non-CAH rural
[[Page 46409]]
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. A complete discussion of assessment
schedules, the MDS, and the transmission software (RAVEN-SB for Swing
Beds) appears in the FY 2002 final rule (66 FR 39562) and in the FY
2010 final rule (74 FR 40288). 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. The latest changes in the MDS for swing-bed
rural hospitals appear on the SNF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/. We
received no comments on this aspect of the proposed rule.
D. Other Issues
1. SNF Value-Based Purchasing (VBP) Program
a. Background
(1) Overview
In recent years, we have undertaken a number of initiatives to
promote higher quality and more efficient health care for Medicare
beneficiaries. These initiatives, which include demonstration projects,
QRPs, and VBP programs, have been implemented in various health care
settings, including physician offices, ambulatory surgical centers
(ASCs), hospitals, nursing homes, home health agencies (HHAs), and
dialysis facilities. Many of these programs link a portion of Medicare
payments to provider reporting or performance on quality measures. The
overarching goal of these initiatives is to transform Medicare from a
passive payer of claims to an active purchaser of quality health care
for its beneficiaries.
We view VBP as an important step toward revamping how care is paid
for, moving increasingly toward rewarding better value, outcomes, and
innovations instead of merely volume.
(2) SNF VBP Report to Congress
Section 3006(a) of the Affordable Care Act required the Secretary
to develop a plan to implement a VBP program under the Medicare program
for SNFs (as defined in section 1819(a) of the Act) and to submit that
plan to Congress. In developing the plan, this section required the
Secretary to consider several issues, including the ongoing
development, selection, and modification process for measures, the
reporting, collection, and validation of quality data, the structure of
value-based payment adjustments, methods for public disclosure of SNF
performance, and any other issues determined appropriate by the
Secretary. The Secretary was also required to consult with relevant
affected parties and consider experience with demonstrations relevant
to the SNF VBP Program.
HHS submitted the Report to Congress required under section 3006 of
the Affordable Care Act in March 2012. The report explains that a
significant number of elderly Americans receive care in SNFs/NFs,
either as short-term post-acute care or as long-term custodial care,
and that quality of care is a significant concern for a subset of SNFs/
NFs. The report also states that the SNF PPS does not strongly
incentivize SNFs to furnish high quality care to this very fragile
patient population. The report concludes that the Medicare program
could incentivize SNFs to improve the quality of care for their
patients.
In the report, we explained our belief that the implementation of a
SNF VBP Program is a central step in revamping Medicare's payments for
health care services to reward better value, outcome, and innovations,
rather than the volume of care. We also explained our belief that a SNF
VBP Program should promote the development and use of robust quality
measures, including measures that assess functional status, to promote
timely, safe, and high-quality care for Medicare beneficiaries. We
noted that the creation of a SNF VBP Program would align with numerous
HHS and CMS efforts to improve care coordination, and would be
consistent with the National Quality Strategy and its aims of Better
Care, Healthy People and Communities, and Affordable Care.
The full report is available on our Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/SNF-VBP-RTC.pdf.
b. Statutory Basis for the SNF VBP Program
Section 215 of PAMA added sections 1888(g) and (h) to the Act.
Section 1888(g)(1) of the Act requires the Secretary to specify a SNF
all-cause all-condition hospital readmission measure (or any successor
to such a measure) not later than October 1, 2015. Section 1888(g)(2)
of the Act requires the Secretary to specify an all-condition risk-
adjusted potentially preventable hospital readmission rate for SNFs not
later than October 1, 2016. Section 1888(g)(3) of the Act directs the
Secretary to develop a methodology to achieve high reliability and
validity for these measures, especially for SNFs with a low volume of
readmissions. Section 1888(g)(4) of the Act makes the pre-rulemaking
Measure Applications Partnership process of Section 1890A of the Act
optional for these measures. Under section 1888(g)(5) of the Act, the
Secretary is directed to provide quarterly confidential feedback
reports to SNFs on their performance on the readmission or resource use
measure beginning on October 1, 2016. Under section 1888(g)(6) of the
Act, not later than October 1, 2017, the Secretary must establish
procedures for making performance data on readmission and resource use
measures public on Nursing Home Compare or a successor Web site. That
paragraph also requires that the procedures ensure that a SNF has the
opportunity to review and submit corrections to the information that is
to be made public for it before that information is made public.
Section 1888(h)(1)(A) of the Act requires the Secretary to
establish a SNF VBP program under which value-based incentive payments
are made in a FY to SNFs, and section 1888(h)(1)(B) of the Act requires
that the Program apply to payments for services furnished on or after
October 1, 2018. Under section 1888(h)(2)(A) of the Act, the Secretary
must apply the readmission measure specified under section 1888(g)(1)
of the Act for purposes of the Program, and section 1888(h)(1)(B) of
the Act requires the Secretary to apply the resource use measure
specified under section 1888(g)(2) of the Act instead of the
readmission measure specified under section 1888(g)(1) as soon as
practicable. Sections 1888(h)(3)(A) and (B) of the Act require the
Secretary to establish performance standards for the measure applied
under section 1888(h)(2) of the Act for a performance period for a FY
and that those performance standards include levels of achievement and
improvement. In addition, in calculating the SNF performance score for
the
[[Page 46410]]
measure under the Program, section 1888(h)(3)(B) of the Act requires
the Secretary to use the higher of achievement or improvement scores.
Further, the performance standards established under section 1888(h)(3)
of the Act must, under section 1888(h)(3)(C), be established and
announced by the Secretary not later than 60 days prior to the
beginning of the performance period for the FY involved.
Section 1888(h)(4) of the Act directs the Secretary to develop a
methodology to assess each SNF's total performance based on the
performance standards for the applicable measure for each performance
period. Under section 1888(h)(4)(B) of the Act, SNF performance scores
for the performance period for each FY must be ranked from low to high.
Section 1888(h)(5) of the Act outlines several requirements for
value-based incentive payments under the SNF VBP Program. Under section
1888(h)(5)(A) of the Act, the Secretary is directed to increase the
adjusted federal per diem rate determined under section 1888(e)(4)(G)
for services furnished by a SNF by the value-based incentive payment
amount determined under section 1888(h)(5)(B). This section also
directs that the value-based incentive payment amount be equal to the
product of the adjusted federal per diem rate and the value-based
incentive payment percentage specified under section 1888(h)(5)(C) of
the Act for the SNF for the FY. Section 1888(h)(5)(C) requires the
Secretary to specify a value-based incentive payment percentage for a
SNF for a FY, which may include a zero percentage. The Secretary is
further directed under section 1888(h)(5)(C) to ensure that such
percentage is based on the SNF performance score for the performance
period for the FY, that the application of all such percentages in a FY
results in an appropriate distribution of value-based incentive
payments, and that the total amount of value-based incentive payments
for all SNFs for a FY be greater than or equal to 50 percent, but not
greater than 70 percent, of the total amount of the reductions to
payments for the FY under section 1888(h)(6), as estimated by the
Secretary.
Section 1888(h)(6) of the Act requires the Secretary to reduce the
adjusted federal per diem rate for SNFs otherwise applicable to each
SNF for services furnished by that SNF during the applicable FY by the
applicable percent, which is defined in paragraph (b) as 2 percent for
FY 2019 and subsequent years. Section 1888(h)(7) of the Act requires
the Secretary to inform each SNF of its payment adjustments under the
Program not later than 60 days prior to the FY involved, and under
section 1888(h)(8) of the Act, the value-based incentive payments
calculated for a FY apply only for that FY.
Section 1888(h)(9)(A) of the Act requires the Secretary to publish
SNF-specific performance information on the Nursing Home Compare Web
site or a successor Web site, including SNF performance scores and
rankings. Section 1888(h)(9)(B) of the Act requires the Secretary to
post aggregate information on the SNF VBP 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.
We received a number of general comments on the SNF VBP Program.
Comment: Commenters suggested that we phase-in the SNFRM to ensure
that providers are fully capable of reporting the measure accurately
and to ensure that it is fully valid and accurate. Commenters suggested
that such a phase-in should include a period of ``hold-harmless
reporting'' and data collection that does not include penalties or
incentive payments.
Response: We do not have the administrative discretion to phase-in
the SNF VBP Program as the commenter suggests, since section
1888(h)(1)(B) of the Act requires us to apply the Program to payments
for services furnished on or after October 1, 2018. However, section
1888(g)(5) requires us to provide quarterly, confidential feedback
reports to SNFs on their performance on measures specified for the
program beginning October 1, 2016. We believe those feedback reports
will meet the commenter's request that we provide feedback on the
measure during a time period that would not involve penalties or
incentive payments. Additionally, we would remind commenters that the
SNFRM is a claims-based measure, and therefore will not require any
additional data to be submitted by SNFs.
Comment: Commenters recommended that proposed measures should
align, where possible, with existing quality measures across settings
and by payment type (such as ACO or bundled payments).
Response: We will take the recommendation into account as we
further develop and implement the Program.
Comment: Commenters urged us to adopt an Extraordinary
Circumstances Exception process for the SNF VBP Program to ensure that
facilities do not incur penalties under the program during major
weather events or other circumstances beyond their control.
Response: We will take the recommendation into account as we
further develop and implement the Program.
Comment: Commenters suggested that we set up a regular workgroup to
discuss the SNF VBP Program's development with stakeholders.
Response: We intend to continue outreach efforts to the SNF
community as we develop the Program.
Comment: Commenters suggested that we should adopt a rule
prohibiting value-based incentive payments under the SNF VBP Program to
any SNF that does not accurately report staffing data or does not have
sufficient nursing staff to meet residents' needs.
Response: We thank the commenters for this suggestion and will
consider it, if legally feasible, as part of the Program's scoring
policies in the future.
Comment: Commenters suggested that we adopt a nutritional status
domain and implement a malnutrition-related quality measure in the
future for the SNF VBP Program. Other commenters suggested measures
that are currently displayed on Nursing Home Compare, those that were
part of the SNF VBP demonstration, or those that are part of the new
SNF QRP.
Response: We do not believe we have the authority to adopt measures
covering additional clinical topics beyond those specified in sections
1888(g)(1) and (2) of the Act at this time.
Comment: Commenters urged us to make SNF VBP Program data as
contemporaneous as possible. Commenters noted that more recent
hospitalization data allow SNFs to monitor their performance and better
realize the connection between their performance rates and their
payment rates.
Response: We intend to make SNFs' performance data available as
quickly as is practicable to ensure that facilities are able to
understand their performance and undertake quality improvement efforts.
Comment: Commenters encouraged us to develop the statutorily-
mandated resource use measure specified under section 1888(g)(2) of the
Act as soon as possible, and to share a timeline for when the measure
will replace the SNFRM. Some commenters also stated that the
potentially preventable hospital readmissions measure needs additional
testing and more detailed public information.
Response: We thank the commenters for this request. At this time,
we have not specified the resource use measure under section 1888(g)(2)
of the Act. We
[[Page 46411]]
will make all details available, including technical reports presenting
results of measure testing and technical expert input, in the future
and will seek public comment.
We thank the commenters for this general feedback, and will take it
into account in future rulemaking.
c. Skilled Nursing Facility 30-Day All-Cause Readmission Measure
(SNFRM) (NQF #2510; Measure Steward: CMS)
(1) Overview
Reducing hospital readmissions is important for quality of care and
patient safety. Readmission to a hospital may be an adverse event for
patients and in many cases imposes a financial burden on the health
care system. Successful efforts to reduce preventable readmission rates
will improve the quality of care furnished to beneficiaries while
simultaneously decreasing the cost of that care. Hospitals and other
health care providers can work with their communities to lower
readmission rates and improve patient care in a number of ways, such as
by ensuring that patients are clinically ready to be discharged,
reducing infection risk, reconciling medications, improving
communication with community providers responsible for post-discharge
patient care, improving care transitions, and ensuring that patients
understand their care plans upon discharge.
Many studies have demonstrated the effectiveness of these types of
in-hospital and post-discharge interventions in reducing the risk of
readmission, confirming that hospitals and their partners have the
ability to lower readmission rates.1 2 3 These types of
efforts during and after a hospitalization have been shown to be
effective in reducing readmission rates in geriatric populations
generally,4 5 as well as for multiple specific conditions.
Moreover, such interventions can result in cost saving. Financial
incentives to reduce readmissions will in turn promote improvement in
care transitions and care coordination, as these are important means of
reducing preventable readmissions.\6\ In its 2007 Report to Congress on
Promoting Better Efficiency in Medicare,\7\ MedPAC noted the potential
benefit to patients of lowering readmissions and suggested payment
strategies that would incentivize hospitals to reduce these rates.
Readmission rates are important markers of quality of care,
particularly of the care of a patient in transition from an acute care
setting to a non-acute care setting, and improving readmissions can
positively influence patient outcomes and the cost of care.
---------------------------------------------------------------------------
\1\ Gwadry-Sridhar FH, Flintoft V, Lee DS, Lee H, Guyatt GH: A
systematic review and meta-analysis of studies comparing readmission
rates and mortality rates in patients with heart failure. Arch
Intern Med. 2004;164(21):2315-2320.
\2\ McAlister FA, Lawson FM, Teo KK, Armstrong PW.: A systematic
review of randomized trials of disease management programs in heart
failure. AmJMed. 2001;110(5):378-384.
\3\ Krumholz HM, Amatruda J, Smith GL, et al.: Randomized trial
of an education and support intervention to prevent readmission of
patients with heart failure. J Am Coll Cardiol. 2002;39(1):83-89.
\4\ Coleman EA, Parry C, Chalmers S, Min SJ.: The care
transitions intervention: Results of a randomized controlled trial.
Arch Intern Med. 2006;166:1822-8.
\5\ Naylor MD, Brooten D, Campbell R, Jacobsen BS, Mezey MD,
Pauly MV, Schwartz JS.: Comprehensive discharge planning and home
follow-up of hospitalized elders: A randomized clinical trial. JAMA.
1999;281:613-20.
\6\ Coleman EA.: 2005. Background Paper on Transitional Care
Performance Measurement. Appendix I. In: Institute of Medicine,
Performance Measurement: Accelerating Improvement. Washington, DC:
National Academy Press.
\7\ Medicare Payment Advisory Commission (MedPAC). Report to
Congress: Promoting Greater Efficiency in Medicare; 2007. Available
at https://www.medpac.gov/documents/Jun07_EntireReport.pdf. Accessed
January 10, 2011.
---------------------------------------------------------------------------
We proposed to specify the SNF 30-Day All-Cause Readmission Measure
(SNFRM) (NQF #2510) as the SNF all-cause, all-condition hospital
readmission measure under section 1888(g)(1) of the Act. This measure
assesses the risk-standardized rate of all-cause, all-condition,
unplanned inpatient hospital readmissions of Medicare fee-for-service
(FFS) SNF patients within 30 days of discharge from an admission to an
inpatient prospective payment system (IPPS) hospital, CAH, or
psychiatric hospital. This measure is claims-based, requiring no
additional data collection or submission burden for SNFs.
We also proposed to apply this measure for purposes of the SNF VBP
Program under section 1888(h)(2)(A) of the Act. We believe that this
measure will (1) incentivize SNFs to make quality improvements that
result in successful transitions of care for patients discharged from
the hospital (IPPS, CAH or psychiatric hospital) setting to a SNF, and
subsequently to the community or to another post-acute care setting,
(2) reduce unplanned readmission rates of these patients to hospitals;
and (3) align the SNF VBP Program with the National Quality Strategy
priorities of safer, better coordinated care and lower costs.\8\
---------------------------------------------------------------------------
\8\ Wilson, N. U.S. Department of Health and Human Services,
Agency for Healthcare Research and Quality. (2014). National quality
strategy: Overview.
---------------------------------------------------------------------------
We developed this measure based upon the NQF-endorsed Hospital-Wide
All-Cause Unplanned Readmission Measure (HWR) (NQF #1789) (https://www.qualityforum.org/QPS/1789) \9\ implemented in the Hospital
Inpatient QRP. To the extent methodologically and clinically
appropriate, we harmonized the SNFRM with the HWR measure
specifications.
---------------------------------------------------------------------------
\9\ Adopted for the Hospital IQR Program in the FY 2013 IPPS/
LTCH PPS Final Rule (77 FR 53521 through 53528).
---------------------------------------------------------------------------
A discussion of the general comments that we received on the SNFRM,
and our responses to those comments, appears below.
Comment: One commenter expressed concern about our proposal to
adopt the SNFRM, stating that it does not align with the unplanned
readmission measure for IRFs (NQF #2502), particularly in reporting
period duration. The commenter stated that we should strive for
alignment between post-acute care settings, particularly given the
ongoing implementation of the IMPACT Act.
Response: We thank the commenter for their comments regarding
alignment of these measures. The SNFRM (NQF #2510) is based on 12
months of data as this ensures an accurate sample size for calculating
the Risk-Standardized Readmission Rate (RSRR). However, 24 months of
data were needed to ensure sufficient sample sizes to reliably estimate
and develop the all-cause, unplanned hospital readmission measures used
in the Inpatient Rehabilitation Facility Quality Reporting Program (NQF
#2502) and the Long-Term Care Hospital Quality Reporting Program, due
to the substantially lower number of IRF and LTCH stays.
While we recognize that the SNFRM does not align with the unplanned
readmission measure for IRFs (#2502), we are currently developing an
unplanned readmission measure for IRFs that is analogous to the SNFRM
in that it assesses readmissions among IRF patients following discharge
from an acute care hospital. This second IRF measure is intended to
exist in tandem with the existing IRF measure #2502, which assesses
readmissions for 30 days following discharge from the IRF.
Comment: Some commenters supported our proposal to adopt the SNFRM,
noting that the measure is consistent with other CMS readmission
measures, and that it will decrease costs, improve patient safety, and
promote the best possible clinical outcomes. Commenters suggested that
we consider adopting additional measures in the future in the SNF VBP
Program that cover resource use,
[[Page 46412]]
functional outcomes, and return to the community following discharge.
Response: We do not have the authority to adopt additional measures
in the SNF VBP Program beyond those specified in sections 1888(g)(1)
and (2) of the Act.
Comment: Some commenters suggested that we either adopt a
readmission measure that includes all SNF patients, regardless of
payer, or clarify that the SNFRM is an ``all-cause fee-for-service
measure'' because it excludes Medicare Advantage beneficiaries.
Response: This measure is based on FFS claims, consistent with
other hospital readmission measures used in other programs. The measure
as specified requires Medicare claims to determine if any readmissions
are deemed to be planned or unplanned and for comprehensive risk
adjustment.
Comment: One commenter recommended that we ask the MAP to review
PointRight OnPoint-30 SNF Rehospitalizations (NQF #2375) before taking
a final position on the SNFRM (NQF #2510). The commenter explained that
#2375 is an MDS-based measure that captures patients regardless of
payer type and also includes observation admissions. The commenter
further noted that #2375 risk adjusts for functional and clinical
symptoms that are strong predictors of readmissions.
Response: We recognize the desirability of implementing an all-
payer readmission measure. However, we have some concerns with
including the measure (NQF #2375) in the SNF VBP program. The MDS-based
measure excludes readmissions that occur after discharge from the SNF,
which creates a perverse incentive for SNFs to discharge patients
prematurely to avoid being penalized if the patients are considered a
high risk for readmission. The MDS-based measure also does not exclude
planned readmissions which are not indications of poor quality.
Additionally, while NQF #2375 adjusts for functional and clinical
symptoms, analyses conducted jointly by the developers of that measure
and the SNFRM concluded that there is no substantial distinction in the
risk models' capacity to assess readmission rates at the facility
level.
Comment: One commenter asked that we clarify that the MAP process
is not restricted to reviewing and commenting only on CMS-sponsored
measures or measures presented by CMS to the MAP, per section 1890 of
the Act. The commenter also requested that we clarify that the input
from the MAP is not with the view that the measure is used for VBP, as
they believed that a measure for payment should be evaluated in a
different manner.
Response: It is correct that other measures are eligible for
consideration in the MAP process. While the MAP provides input on
measures selected by the Secretary, the pre-rulemaking provisions of
the Act do not restrict the MAP from reviewing or recommending measures
and methodologies in lieu of those under consideration by the
Secretary. Therefore, we refer readers to the MAP Web site at https://www.qualityforum.org/map/. Additionally, we intend to provide the
commenters' input to the NQF.
In addition, at times we request additional measures from external
stakeholders and measure developers, which are also reviewed by the
MAP. The MAP's input is responsive to the particular program for which
its review was sought. In this case, the SNFRM was submitted via an ad
hoc Measures Under Consideration list to the MAP for consideration in
SNF-VBP. The MAP's 2015 recommendations, available at https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=78711, show that the MAP supported
the SNFRM's adoption for the SNF VBP Program.
Comment: One commenter opposed the proposed SNFRM, stating that the
measure is self-reported because it is based on MDS information and
that it is industry-developed and controlled.
Response: The proposed SNFRM is based on Medicare claims data and
the measure does not use MDS information. Furthermore, the proposed
measure was developed by CMS working with an independent CMS
contractor, RTI International, and was not industry-developed. The
proposed measure was endorsed by the National Quality Forum (NQF), and
its specifications are available in our technical report, which is
available on our Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/SNFRM-Technical-Report-3252015.pdf.
Comment: Some commenters expressed concern that SNFs will not have
access to the data used to calculate the SNFRM, and will therefore not
be able to validate CMS's calculations.
Response: While we intend to make as much information related to
SNFRM performance as possible available to SNFs through confidential
quarterly feedback reports required under section 1888(g)(5) of the
Act, we understand that claims-based quality measurement is difficult
for providers to replicate. It would require familiarity with a number
of data sources that are used to develop the risk-adjustment model for
SNFRM in order to account for variation across SNFs in case-mix and
patient characteristics predictive of readmission (including the
MedPAR, Medicare Enrollment Database (EDB), Medicare Denominator files,
Agency for Healthcare Research & Quality (AHRQ)'s Clinical
Classification Software (CCS) groupings of ICD-9 codes, and CMS's
hierarchical condition category (HCC) mappings of ICD-9 codes). We view
this as a necessary compromise to minimize reporting burden on
participating SNFs by using claims data while ensuring that we obtain
timely data for quality measurement.
Comment: One commenter suggested that our longer-term goal should
be to align the SNFRM with other relevant hospitalization measures
planned for use, such as those being developed by states under section
1115 waivers and new value-based initiatives for the Medicare fee-for-
service program.
Response: We thank the commenter for this feedback, and will
consider how best to align our programs with these efforts in the
future.
Comment: Some commenters expressed concerns about our proposal to
adopt the SNFRM, stating that further vetting of the measure is
warranted given commenter's belief that research cited on the measure
is spare and includes only effectiveness studies limited to certain
conditions.
Response: The SNFRM was developed using the Measures Management
System (MMS) Blueprint, a process that included input from a TEP and a
public comment period. The measure was also reviewed by the NQF, and
supported by that body for endorsement in December 2014. We believe
that this represents sufficient vetting for the purpose of implementing
a measure in a VBP program. We welcome additional input regarding the
research supporting or questioning the appropriateness of this, or any
other measure.
Comment: One commenter urged us to consider adjusting the SNFRM for
situations beyond facilities' control, such as family members insisting
on a patient being hospitalized, and for patients with increased risks
of hospitalization, including medically complex, frail elderly patients
and those with certain primary diagnoses. The commenter also noted that
avoidable hospital admissions frequently result from poorly managed
transitions, and suggested that we investigate meaningful ways to
capture and incentivize care transitions using this measure.
Response: The SNFRM, which was endorsed by the NQF, has been risk
[[Page 46413]]
adjusted for case-mix to account for differences in patient
populations. The goal of risk adjustment is to account for these
differences so that providers who treat sicker or more vulnerable
patient populations are not unnecessarily penalized for factors that
are outside of their control. The current measure accounts for:
Principal diagnosis from the Medicare claim corresponding to the prior
proximal hospitalization as categorized by AHRQ's CCS groupings, length
of stay during the patient's prior proximal hospitalization, length of
stay in the intensive care unit (ICU), end-stage renal disease (ESRD)
status, whether the patient was disabled, the number of prior
hospitalizations in the previous 365 days, system-specific surgical
indicators, individual comorbidities as grouped by HCCs or other
comorbidity indices, and a variable counting the number of
comorbidities if the patient had more than two HCCs. Many of the
factors, such as family preference, suggested by the commenter are not
feasibly captured by any existing data source of which we are aware.
The medical complexity of patients is captured to the extent possible
through the comorbidity data described above. In this way, we are able
to capture poorly managed transitions through risk adjusted
readmissions rates.
Comment: One commenter encouraged us to consider creating
safeguards for SNFs participating in the Program to ensure that
patients are fully protected from unintended consequences resulting
from the SNFRM's adoption, potentially including functional declines
and resident deaths. The commenter suggested that a companion measure
of death and decline of residents would determine whether SNFs
improperly avoided hospitalizing residents who should have been
hospitalized.
Response: We intend to monitor the effects of the SNFRM on clinical
care closely, and we intend to take any necessary steps to ensure that
SNFs do not avoid hospitalizing patients. Additional measures may be
implemented in other SNF-related programs such as the QRP. However, as
stated above, we do not have the authority to adopt additional measures
under the Program beyond the ones required under sections 1888(g)(1)
and (2) of the Act.
(2) Measure Calculation
The SNFRM estimates the risk-standardized rate of all-cause,
unplanned, hospital readmissions for SNF Medicare FFS beneficiaries
within 30 days of discharge from their prior proximal acute
hospitalization. The SNF admission must have occurred within one day
after discharge from the prior proximal hospitalization. The prior
proximal hospitalization is defined as an inpatient admission to an
IPPS, CAH, or a psychiatric hospital. Because the measure denominator
is based on SNF admissions, each Medicare beneficiary may be included
in the measure multiple times within a given year if they have more
than one SNF stay meeting all measure inclusion criteria including a
prior proximal hospitalization.
Patient readmissions included in the measure are identified by
examining Medicare claims data for readmissions of SNF Medicare FFS
beneficiaries to an IPPS, or CAH occurring within 30 days of discharge
from the prior proximal hospitalization. If the patient was admitted to
the SNF within 1 day of discharge from the prior proximal
hospitalization and the hospital readmission occurred within the 30-day
risk window, it is counted in the numerator regardless of whether the
patient is readmitted directly from the SNF or has been discharged from
the SNF. Because patients differ in complexity and morbidity, the
measure is risk-adjusted for patient case-mix. The measure also
excludes planned readmissions, because these are not considered to be
indicative of poor quality of care by the SNF. Details regarding how
readmissions are identified are available in our SNFRM Technical
Report.\10\
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\10\ Available on the Nursing Home Quality Initiative Web site
at https://www.cms.gov/Medicare/Quality-nitiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/?redirect=/nursinghomequalityinits/.
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The SNFRM (NQF #2510) assesses readmission rates while accounting
for patient demographics, principal diagnosis in the prior
hospitalization, comorbidities, and other patient factors. While
estimating the predictive power of patient characteristics, the model
also estimates a facility-specific effect common to patients treated at
that SNF.
The SNFRM is calculated based on the ratio, for each SNF, of the
number of risk-adjusted all-cause, unplanned readmissions to an IPPS or
CAH that occurred within 30 days of discharge from the prior proximal
hospitalization, including the estimated facility effect, to the
estimated number of risk-adjusted predicted unplanned inpatient
hospital readmissions for the same patients treated at the average SNF.
A ratio above 1.0 indicates a higher than expected readmission rate, or
lower level of quality, while a ratio below 1.0 indicates a lower than
expected readmission rate, or higher level of quality. This ratio is
referred to as the standardized risk ratio or SRR. The SRR is then
multiplied by the overall national raw readmission rate for all SNF
stays. The resulting rate is the risk-standardized readmission rate
(RSRR). The full methodology is detailed in the SNFRM Technical Report.
The patient population includes SNF patients who:
Had a prior hospital discharge (IPPS, CAH or psychiatric
hospital) within 1 day of their admission to a SNF.
Had at least 12 months of Medicare Part A, FFS coverage
prior to their discharge date from the prior proximal hospitalization.
Had Medicare Part A, FFS coverage during the 30 days (the
30-day risk window) following their discharge date from the prior
proximal hospitalization.
A discussion of the general comments that we received on the SNFRM
measure calculation, and our responses to those comments, appears
below.
Comment: One commenter expressed concern about the SNFRM's
readmission window, noting that just over one-third of SNF stays exceed
the 30-day readmission window. The commenter suggested that adopting
the 30-day window as proposed could relieve SNFs of accountability for
longer-stay patients and could create incentives for SNFs to delay
needed care until after day 30. The commenter further stated that SNFs
should be responsible for every readmission that occurs while the
beneficiary is in the SNF.
Response: We agree with the commenter's concerns that SNFs should
be accountable for longer-stay patients who are admitted to an acute
care hospital. The SNFRM is designed to assess failed transitions from
an acute care hospital to the SNF, and is not intended to capture all
hospitalizations that may occur in a SNF population. Including all
admissions beyond 30 days in the population would attenuate the
association between the transitions of care at the proximate discharge
from an acute care hospital to the readmission.
Comment: Some commenters stated that the SNFRM does not hold SNFs
fully accountable for transitions to the next care setting, and
suggested that we should adopt separate measures of readmissions after
discharge from the SNF and from the hospital. One commenter stated that
the SNFRM's measurement period should capture rehospitalizations within
90 days, not just 30 days. The commenter noted that other efforts to
reduce rehospitalizations
[[Page 46414]]
focus on a 90-day time period, and suggested that the 30-day period may
reflect poor hospital care more than care problems in the SNF.
Response: The 30-day readmission window was developed to harmonize
with other hospital readmission measures and reflects a transitional
time period during which the acute care hospital and SNF are
responsible for coordinating the care of a patient moving from one
setting to another. While there is no definitive timeframe for which
such a measure may be applied, the 30-day window is consistent with
similar measures applied in other VBP programs, such as the ESRD
Quality Incentive Program and the Hospital Readmission Reduction
Program, as well as a number of QRPs. Furthermore, this 30-day post-
hospital discharge window was reviewed by a TEP. Analysis of
readmission rates showed no patterns indicating that using a shorter or
longer period would produce very different comparative results, though
the overall rates would change. In addition, the NQF Standing Committee
generally agreed that 30 days post-hospital discharge is an accepted
standard for measuring readmissions. Longer windows may be subject to
greater ``noise'' or statistical variability in the readmission rate.
The measure as specified has the potential for this unintended
consequence of delaying hospital care beyond the 30-day readmission
window, but this issue may occur with any selected day threshold. We
will be closely monitoring this and continue to analyze whether there
are changes in the number of days to hospital readmission over time to
assess whether a change to the readmissions window is needed for this
measure in the future.
Comment: One commenter expressed concern about the time lag between
the end of the measurement period and the release of clean, adjudicated
claims data. The commenter was concerned that these delays could affect
timely notice and payment for SNFs participating in the Program.
Response: We share the commenters' concern. As required by statute,
we intend to provide quarterly feedback to SNFs to ensure that
facilities have as much information as possible to inform their quality
improvement efforts.
Comment: Commenters expressed concern that while the SNFRM accounts
for principal diagnosis, that diagnosis may not be the reason for
admission to a SNF. Commenters suggested that the SNFRM should also
account for comorbidities, diagnoses from prior hospitalizations during
the prior year, length of stay during the prior proximal
hospitalization, length of stay in the ICU, body system specific
surgical indicators, ESRD status, disability status, and number of
prior hospitalizations during the previous year. Commenters also
requested that we develop a list of comorbidities that are being
evaluated in the SNFRM's risk adjustment model.
Response: We would like to clarify that the SNFRM is risk-adjusted
for all of the factors cited by the commenter. The SNFRM accounts for
all of the factors proposed in the comment above, including first
diagnosis from the Medicare claim corresponding to the prior proximal
hospitalization as coded by the AHRQ's CCS, length of stay during the
patient's prior proximal hospitalization, indicator of a stay in the
ICU, ESRD status, whether the patient was disabled, the number of prior
hospitalizations in the previous 365 days, system-specific surgical
indicators, individual comorbidities as grouped by CMS's (HCCs, and a
variable counting the number of comorbidities if the patient had more
than two HCCs. To capture comorbidities, we used the secondary medical
diagnoses listed on the patient's prior proximal hospital claim as well
as all diagnoses listed on acute care hospitalizations that occurred in
the prior 12 months. We refer the commenter to the Technical Report for
the SNFRM for additional information, which can be found on the Nursing
Home Quality Initiative Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/.
Comment: Some commenters disagreed with our proposal to adopt a
measure based on claims data, stating that determining readmission
rates will be difficult for SNFs since claims data are cumbersome to
use or access. Commenters stated that the SNFRM will not provide
meaningful insights or otherwise impact quality improvement efforts
when facilities are unable to interpret or access the data.
Response: This measure was developed to harmonize with other
hospital-based measures that are claims-based. Despite the commenter's
concern that these data are difficult to access, the measure developer
(RTI) cited evidence that these data are both reliable and valid.
Further detail on this evidence is available in the SNFRM Technical
Report, Section 3.5 (Validity Testing), available on the Nursing Home
Quality Initiative Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/.
Furthermore, we intend to make performance reports available to
facilities that are easy to interpret and present information on the
facility-level readmission rates and relative standing on this measure,
rather than information from the claims data directly. We intend to
make SNFs' performance data available as quickly as is practicable.
This will serve to provide information on a facility's performance and
aid in informing quality improvement efforts at the facility level.
Comment: One commenter stated that readmission measures should be
``normalized'' instead of reported in simple percentage rates. The
commenter believed that reductions in hospital admissions could result
in more measured readmissions, even if the normalized readmission rate
has remained constant. The commenter also suggested that undue
variation may result for smaller facilities and fewer admissions.
Response: The percentages computed by the measure are normalized in
the sense that they are computed with risk adjustment and may be
compared to one another and to the national rate for SNFs. A ratio of
the risk-adjusted predicted rate for each facility to the expected rate
for the same patients at the average facility produces a normalized
value (referred to as the standardized risk ratio) which is 1.0 for a
facility with readmissions at the expected rate for its own patients,
and higher or lower than 1.0 if the readmission rate is higher or
lower. For ease of interpretation, this standardized risk ratio is
converted to a standardized rate by multiplying it by the national raw
rate. This is an accepted method for producing standardized rates that
are comparable across facilities. There is no external percentage
target that every facility must meet and the national mean rate is
driven by the data for the measurement period. The national mean may go
up or down over time reflecting a changing pool of patients, medical
conditions, and treatments.
Variation in rates that may occur in facilities with low volume is
dealt with by averaging the volatile facility data with the national
mean when the hierarchical models are used. In addition, we will
consider appropriate facility volume thresholds for reporting depending
on the use of the measure.
Comment: One commenter recommended that we adopt a minimum of 30
qualified FFS admissions per 12-month period to calculate a
statistically valid SNFRM rate. The commenter further stated that
[[Page 46415]]
any SNFs with fewer events should be excluded from the measure's
calculation.
Response: We will consider whether we should establish a minimum
number of qualifying admissions for the SNFRM in future rulemaking. The
SNFRM utilizes shrinkage estimates to address the possibility of undue
variation for smaller facilities. This is a design feature common to
many of our readmission measures, including those implemented in the
aforementioned programs, to ensure statistically valid rates.
Comment: One commenter stated that we should only count
readmissions that occur while the patient resides in the SNF, not after
discharge. The commenter stated that measure readmissions within the
30-day window but after SNF discharge necessitates measurement of 30-
day rehospitalization rates for other providers as well. Commenters
also noted that PAMA does not specify that the SNF measure align with
the hospital's 30-day window and the Act uses ``Skilled Nursing
Facility Measure'' throughout, which some commenters read to mean SNF
only, not SNF plus follow on care after discharge.
Response: We agree that readmission rates for other providers are
necessary, and this is one reason we have taken steps to implement
readmissions measures in multiple settings across a wide variety of
relevant quality programs. We believe that excluding readmissions that
occur after discharge creates a perverse incentive for facilities to
prematurely discharge patients who represent the highest risk for
readmission to avoid penalty. Given that this measure is the sole
determinant of a VBP program for SNFs, we believe it is appropriate to
include readmissions that occur post-discharge but within the 30-day
window, aligning with other readmission measures implemented by CMS.
The goal of this measure is to capture readmissions that are
attributable to care provided by the SNF, even those that occur after
discharge. We have already established a panel of readmission measures
(such as those utilized for hospitals, ESRD care, IRFs, and LTCHs) that
similarly seek to identify readmissions attributable to care received
within the facility, even if the patient has been discharged. Those
developed for ESRD facilities and Home Health agencies follow a 30-day
window as well. We believe that the 30-day window is consistent with
PAMA and that it is also consistent with the standard implemented in
multiple settings. Absent a compelling reason to limit the measure to
within stay, and given the potential for unintended consequences if
such a measure were implemented as the sole determining factor of a VBP
program, we believe remaining consistent with other programs is
appropriate. We might consider a purely within-stay measure were it
paired with a post-discharge measure, as this would allow us to avoid
unintended consequences to patients, such as inappropriate early
discharge from the SNF, but the statutory mandate does not allow us to
implement additional measures in the SNF-VBP program.
Comment: One commenter requested that we clarify whether the SNFRM
includes all hospitalizations billed to Medicare or if it is limited to
hospitalizations of residents who are in a Part A stay in a SNF. The
commenter suggested that a broader measure of readmissions, including
Medicare claims for dually-eligible residents not in a Part A stay or
for private-pay residents could be used.
Another commenter suggested that we explore merging FFS and
Medicare Advantage data sets given the relative prevalence of MA
patients in the SNF setting. The commenter also noted that the IMPACT
Act does not separate Medicare beneficiaries by MA status. The
commenter also recommended that facilities be allowed to complete and
submit a combined Admission Assessment with the 5-day Assessment for
Medicare Advantage beneficiaries to track readmission outcome data for
all payer types in the facility.
Response: The index stays that are included in the proposed SNFRM
are for those that have FFS Part A Medicare enrollment. We do not have
claims data for managed care, private pay, or Medicaid residents who
may be receiving skilled services. Thus, this measure only includes
Medicare FFS patients.
For private-pay residents, we do not always have claims for the
index hospital stay (the proximate stay at an acute-care hospital that
precedes care with a SNF and defines the denominator), even if the
related readmissions could be identified in Medicare data. In addition,
we do not have reliable sources of data for Medicare Advantage
patients. The most reliable data available for determining readmissions
during a SNF stay are for Part A FFS beneficiaries.
We agree that as penetration of the Medicare Advantage market in
the SNF setting increases, finding ways of including readmissions for
these patients should be a priority. We will continue to explore ways
to include these patients in future years, given the differences in
data sources.
Comment: Another commenter also expressed concern that the SNFRM
captures only Medicare FFS beneficiaries. The commenter noted that the
SNF VBP Program's statute does not specifically restrict the measure to
FFS beneficiaries, and urged us to find an all-payer measure. The
Commenter further noted that the SNFRM does not capture hospital
admissions that are classified as ``observation status,'' which are
paid under Part B, and stated that the measure should be broadened to
include residents not in a Medicare Part A stay.
Response: At present, we are not able to include all payers in the
SNFRM, as the measure is dependent upon Medicare claims data to
identify readmissions and risk-adjust for patient comorbidities. While
an all-payer measure based on the MDS does exist, it has several
characteristics that we believe are potentially problematic for use in
a VBP program. The MDS-based measure excludes readmissions that occur
after discharge from the SNF, which creates a perverse incentive for
SNFs to discharge patients prematurely to avoid being penalized if they
are considered a high risk for readmission. The MDS-based measure also
does not exclude planned readmissions, which are not indications of
poor quality. We do not believe observation stays are appropriate for
inclusion in the readmission measure, because the statute requires a
measure of readmissions, not of rehospitalizations, which could also
include ED and outpatient visits, including observation stays. We have
tested the inclusion of observation stays, and note that doing so would
have little or no impact on facility assessment by the measure. In
addition, evidence suggests that the number of observation stays of
patients originating from a SNF is quite small in comparison to the
total number of SNF stays (0.7 percent of all SNF stays), and very few
readmissions occur after an observation stay. Including observation
stays from the SNF hospital readmission measure will not make a
meaningful difference in the SNF facility-level rate of hospital
readmissions or in the relative ranking of SNF providers according to
this measure.
Comment: One commenter requested that we clarify whether the
SNFRM's condition list has been tested for the ICD-10 transition
scheduled to be completed on October 1, 2015.
Response: We will monitor and test the measure performance and
update the risk adjustment model with the transition to ICD-10. We are
prepared
[[Page 46416]]
for the implementation of ICD-10 for this measure. Mappings of ICD-10
codes for the diagnoses and procedures have been prepared by the AHRQ
for the CCS groups used in the risk-adjustment models. Similarly,
mappings to the HCC groups have been done. These are used in the risk
adjustment of the measure and the definition of planned readmissions.
The effects of the change of codes will be system-wide and the models
will be re-estimated when the necessary new data become available with
the implementation of ICD-10.
Comment: One commenter suggested that we use SNFs' actual
readmission rate rather than predicted actual. The commenter noted that
the predicted actual rate mutes the differences in rates for small
sample size (for example, a facility with an actual count of 0
readmissions could have a projected rate that is greater than 0).
Response: This measure and several other post-acute care measures
were designed to align with the Hospital-Wide Readmission measure for
all-cause readmissions, and these measures utilize a hierarchical
modeling approach that relies on generating a predicted rate consistent
with recommendations made in the 2011 Committee of Presidents of
Statistical Societies commissioned paper Statistical Issues in
Assessing Hospital Performance.\11\ This decision was made based on the
validity of calculating the standardized risk ratio (SRR), which is the
predicted number of readmissions at the facility divided by the
expected number of readmissions for the same patients if these patients
had been treated at the average SNF. The predicted number of
readmissions for each SNF is calculated as the sum of the predicted
probability of readmission for each patient in the facility, including
the SNF-specific (random) effect. The measure developer (RTI
International) also designed a test to explore calibration over ranges
of predicted probabilities by doing a comparison of the observed and
predicted readmissions by decile (for a table of results, please refer
to the SNFRM Technical Report, Section 3.3 Model Validation). These
results indicate that the difference between the predicted number of
readmissions and the observed number of readmissions in percentage
points is minimal, less than one percentage point across deciles of
expected rates of readmission, which suggests that the differences in
rates will not be muted by using the predicted rate.
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\11\ The COPSS-CMS White Paper Committee: Arlene S. Ash, Ph.D.;
Stephen E. Fienberg, Ph.D.; Thomas A. Louis, Ph.D.; Sharon-Lise T.
Normand, Ph.D.; Therese A. Stukel, Ph.D., Jessica Utts, Ph.D.
Available for download here: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Downloads/Statistical-Issues-in-Assessing-Hospital-Performance.pdf.
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Comment: One commenter suggested that we increase the minimum
denominator size to address small volume variation. The commenter noted
many SNFs admit fewer than 50 Medicare FFS beneficiaries per year and
some of these would be excluded if the proposed minimum denominator
size of 25 stays is adopted. They also noted that for facilities with
Ns smaller than 40, the confidence intervals of the readmission rate
start to increase; for Ns smaller than 30, the confidence intervals
increase rapidly. The commenter recommended that we should show both
the impact that different minimum denominator sizes have on the number
of SNFs excluded and the range of confidence intervals of the SNFs
rehospitalization rates for Ns smaller than 50 to below 20. They also
recommended that bootstrap analysis be conducted to test minimum
denominator size to see how the confidence interval around small
facilities increases as the denominator decreases as was done for NQF
#2375.
Response: We did not propose a minimum denominator size of 25
stays, nor did we specify any minimum SNF size for inclusion. We will
consider whether we should establish a minimum denominator for the
SNFRM in future rulemaking along with the scoring methodology we are
developing for the SNF VBP Program.
(3) Exclusions
Patients whose prior proximal hospitalization was for the medical
treatment for cancer are excluded. Analyses of this population during
measure development showed them to have a different trajectory of
illness and mortality than other patient populations, which is
consistent with findings in studies in other patient populations.\12\
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\12\ National Quality Forum. ``Patient Outcomes: All-Cause
Readmissions Expedited Review 2011''. July 2012. pp. 12.
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SNF stays excluded from the measure are:
SNF stays where the patient had one or more intervening
post-acute care (PAC) admissions (inpatient rehabilitation facility
(IRF), long-term care hospital (LTCH), or another SNF) which occurred
either between the prior proximal hospital discharge and SNF admission
(from which the patient was readmitted) or after the SNF discharge but
before the readmission, within the 30-day risk window.
SNF stays with a gap of greater than 1 day between
discharge from the prior proximal hospitalization and the SNF
admission.
SNF stays in which the patient was discharged from the SNF
against medical advice (AMA).
SNF stays in which the principal diagnosis for the prior
proximal hospitalization was for rehabilitation care; fitting of
prostheses and for the adjustment of devices.
SNF stays in which the prior proximal hospitalization was
for pregnancy.
SNF stays in which data were missing on any variable used
in the SNFRM construction.
Readmissions within the 30-day risk window that are usually
considered planned due to the nature of the procedures and principal
diagnoses of the readmission are also excluded from the measure. In
addition to the list of planned procedures is a list of diagnoses
(provided in the SNFRM Technical Report), which, if found as the
principal diagnosis on the readmission claim, would indicate that the
usually planned procedure occurred during an unplanned acute
readmission. In addition to the HWR Planned Readmission Algorithm, the
SNFRM incorporates procedures that are considered planned in post-acute
care settings as identified in consultation with TEPs. Full details on
the planned readmissions criteria used, including the additional
procedures considered planned for post-acute care may be found in the
SNFRM Technical Report. Details regarding the TEP proceedings can be
found in the SNFRM TEP Report.
A discussion of the general comments that we received on the SNFRM
exclusions, and our responses to those comments, appears below.
Comment: One commenter suggested that we should not limit the SNFRM
to a 30-day readmission window, and should hold SNFs accountable for
all readmissions that occur while a beneficiary is in a SNF. The
commenter also suggested that we adopt a SNF measure that holds SNFs
accountable for readmissions 30 days after discharge from the SNF,
which commenters stated would help ensure smooth care transitions.
Response: We agree with the commenter's concerns that SNFs should
be accountable for longer-stay patients who are readmitted to an acute
care hospital. The SNFRM is designed to assess failed transitions from
acute care to the SNF, and is not intended to capture all
hospitalizations that may
[[Page 46417]]
occur in a SNF population. Including all admissions beyond 30 days in
the population would attenuate the association between the transitions
of care at the proximate discharge from an acute care hospital to the
readmission. Adding additional measures to account for readmissions
post discharge from the SNF seems a reasonable suggestion, but we lack
the statutory authority to include additional quality measures in the
SNF VBP program.
Comment: One commenter expressed concern about the SNFRM's
exclusion of patients admitted to SNFs from inpatient rehabilitation
facilities and long-term care hospitals. The commenter agreed that
these patients may be in a different phase of recovery than acute care
hospital patients, but suggested that they should still be included in
the measure with a separate risk adjustment method.
Response: We excluded patients who have intervening IRF or LTCH
admissions before their first SNF admission. While developing the
measure specifications, we found that these patients started their SNF
admission later in the 30-day readmission window and received other
additional types of services as compared with patients admitted
directly to the SNF from the prior proximal hospitalization. Thus, they
are clinically different, and their risk for readmission is different
from the rest of SNF admissions. We report details on this exclusion in
the SNFRM Technical Report.\13\ SNF patients with intervening IRF/LTCH
stays had the lowest rates of readmission (8.6 percent) as compared
with those with no intervening IRF/LTCH stay.
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\13\ Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/SNFRM-Technical-Report-3252015.pdf.
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Additionally, we found that those with intervening IRF/LTCH
admissions had longer hospital lengths of stay and more prior proximal
hospitalizations involving surgical procedures compared to those
without an intervening stay. This observation supports the rationale
that patients who had intervening IRF/LTCH stays are entering the SNF
at a later stage of their recovery and are therefore at a different
risk for readmission than patients who were admitted directly to the
SNF from their prior proximal hospitalization. This issue also impacts
a relatively small number of SNF stays; 6 percent have an intervening
PAC stay (IRF, LTCH, or another SNF) or go home from their prior
proximal hospitalization and are later admitted to a SNF within the 30-
day readmission window.
Combined, these analyses provide justification for excluding SNF
admissions with intervening IRF or LTCH admissions, or with multiple
SNF stays, by showing these exclusions will not have a substantial
effect on the SNFRM. Patients with multiple PAC stays after a prior
proximal hospitalization are not systematically different from those
with only one SNF stay with regard to comorbidities, but are very
different with regard to readmission risk. Additionally, concerns about
attribution, given the mix of providers these patients have received
services from during the risk period, argues for the appropriateness of
excluding these patients. Lastly, patients with multiple PAC stays do
not cluster in a small group of facilities, so no facilities are
disproportionately impacted by these exclusions.
Comment: One commenter strongly disagreed with the SNFRM's
exclusion criteria where the patient had one or more intervening
admissions to an IRF which occurred either prior to the proximal
hospital discharge and SNF admission or after the SNF discharge but
before the readmission. The commenter stated that the criteria would
not take into account medically complex patients who may be readmitted
to the hospital for issues treated as comorbidities. The commenter
stated that admission to an IRF should be considered as a proximal
hospitalization.
Response: With regard to considering an IRF stay as a proximal
hospitalization, we would like to clarify that this measure was
developed to harmonize with other hospital readmission measures which
do not consider post-acute care settings, like IRFs, as proximal
hospitalizations. We have previously adopted a hospital readmission
measure for the IRF QRP and have adopted the NQF-endorsed version of
the All-Cause Unplanned Readmission Measure for 30 Days Post Discharge
from an IRF (NQF #2502) for the IRF QRP. Although IRFs are licensed as
hospitals, we include them in the PAC continuum of care and as such,
have proposed NQF #2502 to account for readmissions following discharge
from the IRF setting.
Comment: One commenter suggested that we exclude ventilator-
dependent residents from the readmission measure when those patients'
prior proximal hospitalization required being placed on a ventilator
for the first time. The commenter noted that these patients require
frequent rehospitalizations as part of the adjustment to ventilator
dependency.
Response: This measure of all-cause unplanned hospital readmission
measures was harmonized with measures adopted in other inpatient and
post-acute care programs. Consistent with these other measures, we do
not exclude these types of patients. Rather, the measure is designed to
take into account a variety of patient-level risk factors through risk
adjustment, including principal diagnoses or comorbidities that require
use of mechanical ventilation.
Comment: One commenter supported our proposal to exclude from the
measure those patients whose prior proximal hospitalization was for
medical treatment of cancer, and encouraged us to examine whether other
populations should be excluded from the measure as well.
Response: The rationale for excluding from the measure patients
whose prior proximal hospitalization was for medical treatment of
cancer is that these patients with these admissions have a very
different mortality and readmission risk from the rest of the Medicare
population, and outcomes for these admissions do not correlate well
with outcomes for other patients, as determined in the development of
the Hospital-Wide Readmission (HWR) measure (NQF #1789). Further detail
and relevant analyses supporting this exclusion criterion are available
in the SNFRM Technical Report, section 2.3.1. In the development of the
HWR and SNFRM measures, we have not identified additional patient
populations or medical conditions whose post-discharge trajectory of
readmissions was not consistent with other patient groups such that
they would require exclusion from the measure as well.
Comment: One commenter suggested that we include planned
readmissions in the denominator but exclude them from the numerator of
the SNFRM. The commenter noted that the way planned readmissions are
counted is not clear in the rule. In one section, commenter noted, the
rule stated that they are excluded; in another, it states that they are
included in the denominator but excluded from the numerator.
Response: We would like to clarify that the measure includes
planned readmissions in the denominator but excludes them from the
numerator. This is consistent with how planned readmissions are treated
in in the Hospital-Wide All-Cause Unplanned Readmission Measure (HWR),
upon which this measure is based.
[[Page 46418]]
(4) Eligible Readmissions
An eligible SNF admission is considered to be in the 30-day risk
window from the date of discharge from the proximal acute
hospitalization until: (1) The 30-day period ends; or (2) the patient
is readmitted to an IPPS or CAH. If the readmission is unplanned, it is
counted as a readmission in the numerator of the measure. If the
readmission is planned, the readmission is not counted in the numerator
of the measure. The occurrence of a planned readmission ends further
tracking for readmissions in the 30-day period.
We did not receive any comments on the specific topic of eligible
readmissions. However, we addressed comments on exclusions from the
measure above.
(5) Risk Adjustment
Readmission rates are risk-adjusted for patient case-mix
characteristics, independent of quality. The risk adjustment modeling
estimates the effects of patient characteristics, comorbidities, and
select health status variables on the probability of readmission. More
specifically, the risk-adjustment model for SNFs accounts for
demographic characteristics (age and sex), principal diagnosis during
the prior proximal hospitalization, comorbidities based on the
secondary medical diagnoses listed on the patient's prior proximal
hospital claim and diagnoses from prior hospitalizations that occurred
in the previous 365 days, length of stay during the patient's prior
proximal hospitalization, length of stay in the ICU, body system
specific surgical indicators, ESRD status, whether the patient was
disabled, and the number of prior hospitalizations in the previous 365
days.
A discussion of the general comments that we received on the SNFRM
risk adjustment, and our responses to those comments, appears below.
Comment: Some commenters urged us to adjust the proposed
readmission measure for sociodemographic factors before the SNF VBP
Program is implemented in FY 2019. Commenters stated that factors
outside the control of the hospital, such as availability of primary
care, mental health services, access to medications and appropriate
food, may significantly influence the likelihood of a patient's health
improving after hospital discharge and whether a readmission may be
necessary. Commenters suggested that we consider using proxy data on
sociodemographic status, such as census-derived data on income and
education level, and claims data on the proportion of patients dually
eligible for Medicare and Medicaid, to adjust the SNFRM.
One commenter stated that we should submit the SNFRM to NQF under
its pilot program for socioeconomic risk adjustment evaluation. The
commenter stated that many SNFs provide care to the most vulnerable
residents of their communities and that those patients present greater
challenges in maintaining optimal medical and functional outcomes,
including greater risk for readmission.
Another commenter stated that the SNFRM, and any other measures
used in the VBP program, should be appropriately risk adjusted for the
population served. The commenter stated that there is significant
variation in size, patient populations, and scope of service that are
not fully accounted for by current risk adjustments. The commenter also
stated that readmission predictors are more highly linked to functional
needs and family/caregiver support resources, neither of which are
included in risk adjustment.
Response: While we appreciate these comments and the importance of
the role that sociodemographic status plays in the care of patients, we
continue to have concerns about holding providers to different
standards for the outcomes of their patients of low sociodemographic
status because we do not want to mask potential disparities or minimize
incentives to improve the outcomes of disadvantaged populations. We
routinely monitor the impact of sociodemographic status on facilities'
results on our measures.
NQF is currently undertaking a 2-year trial period in which new
measures and measures undergoing maintenance review will be assessed to
determine if risk-adjusting for sociodemographic factors is appropriate
for each measure. For 2 years, NQF will conduct a trial of a temporary
policy change that will allow inclusion of sociodemographic factors in
the risk-adjustment approach for some performance measures. At the
conclusion of the trial, NQF will determine whether to make this policy
change permanent. Measure developers must submit information such as
analyses and interpretations as well as performance scores with and
without sociodemographic factors in the risk adjustment model.
Furthermore, the Office of the Assistant Secretary for Planning and
Evaluation (ASPE) is conducting research to examine the impact of
socioeconomic status on quality measures, resource use, and other
measures under the Medicare program as directed by the IMPACT Act. We
will closely examine the findings of these reports and related
Secretarial recommendations and consider how they apply to our quality
programs at such time as they are available.
Comment: One commenter requested that residents identified as
residing in a designated sub-acute unit within a SNF be considered
under the ``other health status'' variable for risk adjustment.
Response: We undertake annual maintenance of our quality measures.
We will consider this suggestion through this process. We thank the
commenters for their contribution.
Comment: One commenter noted that certain SNFs specialize in
serving certain patient populations that are associated with higher
rates of hospitalization, and stated that our risk adjustment model
should not inadvertently penalize SNFs that offer these programs.
Response: We believe that the risk adjustment model that we have
proposed for the SNFRM will ensure that SNFs serving more complex
patient populations will not be penalized inadvertently under the SNF
VBP Program.
Comment: One commenter stated that we should consider adjusting the
SNFRM using HCCs based on hospital and outpatient claims during the
prior year rather than the number of prior hospital stays for a
facility. The commenter suggested that HCCs are more likely to capture
the full risk of a patient's comorbidities than secondary diagnoses
coded during the immediately preceding hospital stay.
Response: To clarify, we note that this measure uses for risk
adjustment the HCCs based on hospital claims from the prior year in
addition to secondary diagnoses coded during the immediately preceding
hospital stay. Consistent with other hospital readmission measures,
this measure captures HCCs based only on inpatient claims and does not
include outpatient claims.
(6) Measurement Period
The SNFRM utilizes 1 year of data to calculate the measure rate.
Given that there are more than 2 million Medicare FFS SNF admissions
per year in more than 15,000 SNFs, 1 year of data is sufficient to
calculate this measure with a model in which the risk adjusters have
sufficient sample size to have good precision. The relevant reliability
testing may be found in the SNFRM Technical Report.
We sought public comments on the SNFRM's measurement period, and
have responded to them in the ``FY 2019 Performance Period and Baseline
Period Considerations'' section below.
[[Page 46419]]
(7) Stakeholder/MAP Input
Our measure development contractor convened a TEP which provided
input on the technical specifications of this quality measure. The TEP
was supportive of the design of this measure. We also solicited
stakeholder feedback on the development of this measure through a
public comment process from July 15th to 29th, 2013. In December 2014,
the NQF endorsed the SNF 30-Day All-Cause Readmission Measure (NQF
#2510).
We also considered input from the Measures Application Partnership
(MAP) when selecting measures under the CMS SNF VBP Program. The MAP is
composed of multi-stakeholder groups convened by the NQF, our current
contractor under section 1890(a) of the Act. The MAP has noted the need
for care transition measures in PAC/Long Term Care (LTC) performance
measurement programs and stated that setting-specific admission and
readmission measures under consideration would address this need.\14\
We included the SNFRM on the December 1, 2014 List of Measures under
Consideration (MUC List), and the MAP supported the measure. A
spreadsheet of MAP's 2015 Final Recommendations is available at NQF's
Web site at https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=78711.
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\14\ National Quality Forum. Measure Applications Partnership
Pre-Rulemaking Report: 2013 Recommendations of Measures Under
Consideration by HHS: February 2013. Available at https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=72738.
---------------------------------------------------------------------------
We sought public comments on our proposal to adopt the SNF 30-Day
All-Cause Readmission Measure (SNFRM) (NQF #2510) for use in the SNF
VBP Program, and our responses appear in subsections i. through vii.
above, as well as in subsection viii. below.
(8) Feedback Reports to SNFs
Section 1888(g)(5) of the Act requires that beginning October 1,
2016, SNFs be provided quarterly confidential feedback reports on their
performance on measures specified under sections 1888(g)(1) or (2) of
the Act.
We intended to address this topic in future rulemaking. However, we
requested public comment on the best means by which to communicate
these reports to SNFs. For example, we could consider providing
confidential, downloadable feedback reports to SNFs through a secure
portal, such as QualityNet. We also invited comment on the level of
detail that would be most helpful to SNFs in understanding their
performance on the new quality measures. The comments we received on
these topics, with their responses, appear below.
Comment: One commenter supported our suggested plan to provide
SNFRM feedback reports to SNFs via a secure portal such as QualityNet.
The commenter suggested that we provide full details on how their
scores were determined, including data on readmitted beneficiaries and
details on SNFs' rankings, so that facilities may validate their
performance and perform quality improvement efforts.
Response: We will provide information to providers on facilities'
scores on this measure. As discussed further below, we intend to
consider what information should be included in SNFRM feedback reports
in the future, and we will further consider the commenter's feedback
when we develop our proposals on that topic. However, while we may
provide information pertaining to a patient's readmission episode, we
cannot interpret such determinations and readmission rationales, or
provide post-discharge information. As part of their quality
improvement and care coordination efforts, SNFs are encouraged to
monitor hospital readmissions and follow up with patients post
discharge. Therefore, although we will not be providing specific
information at the patient level in the feedback reports, we believe
that SNFs will monitor their overall hospital readmission rates and
assess their performance.
Comment: One commenter noted that the quarterly feedback reports
required under the Program will use claims data, but that these data
may not be accurate if SNFs do not submit their claims timely. The
commenter noted that SNFs have up to 12 months to submit claims, which
may affect performance measurement.
Response: We intend to monitor SNFRM performance to ensure that
unintended consequences related to the time facilities have to submit
or resubmit claims do not result.
After consideration of the public comments that we have received,
we are finalizing our proposal to specify the SNF 30-Day All-Cause
Readmission Measure (SNFRM) (NQF #2510) and to adopt the measure for
the SNF VBP as the SNF all-cause, all-condition hospital readmission
measure under section 1888(g)(1) of the Act as proposed.
d. Performance Standards
(1) Background
Section 1888(h)(3) of the Act requires the Secretary to establish
performance standards for the SNF VBP Program. The performance
standards must include levels of achievement and improvement, and must
be established and announced not later than 60 days prior to the
beginning of the performance period for the FY involved. To assist us
in developing our proposals to establish performance standards for the
SNF VBP program, we reviewed a number of innovative health care
programs and demonstration projects, both public and private, to
discover if any could serve as a prototype for the SNF VBP program. One
methodology of important note that provides us an analogous framework
for implementation of performance standards is the Performance
Assessment Model, implemented for our Hospital VBP program. We also
reviewed the Hospital Acquired Conditions Reduction Program, as well as
the Hospital Readmissions Reduction Program and the End-Stage Renal
Disease Quality Incentive Program (ESRD QIP).
We invited comment on several potential approaches for calculating
performance standards under the SNF VBP Program. The comments we
received on this topic, with their responses, appear below after
discussion of these potential approaches.
(a) Hospital Value-Based Purchasing Program
Under the Hospital VBP Program, a hospital's Total Performance
Score is determined by aggregating and weighting domain scores, which
are calculated based on hospital performance on measures within each
domain. The domain scores are then weighted to calculate a TPS that
ranges between 0 and 100 points. At this time, we do not anticipate
proposing to adopt quality measurement domains akin to other CMS
quality programs under the SNF VBP Program due to fact that this
program is based on only one measure.
To calculate HVBP measure scores, hospital performance on specified
quality measures is compared to performance standards established by
the Secretary. These performance standards include levels of
achievement and improvement and enable us to award between 0 and 10
points to each hospital based on its performance on each measure during
the performance period. An achievement threshold, generally defined as
the median of all hospital performance on most measures during a
specified baseline period, is the minimum level of performance required
to receive achievement points. The benchmark, generally defined as the
[[Page 46420]]
mean of the top decile of all hospital performance on a measure during
the baseline period, is the performance level required for receiving
the maximum number of points on a given measure. The Program also
establishes an improvement threshold for each measure, set at each
individual hospital's performance on the measure during the baseline
period, to award points for improvement over time.
We believe that the Hospital VBP Program's performance standards
methodology is a well-understood methodology under which health care
providers and suppliers can be rewarded both for providing high-quality
care and for improving their performance over time. The statutory
authority for the Hospital VBP Program is structured similarly to the
statutory authority for the SNF VBP Program, and we are considering
adoption of a similar methodology for establishing performance
standards under the SNF VBP Program. We also seek to align our pay-for-
performance and QRPs as much as possible. Specifically, we could
consider adopting performance standards based on all SNF performance
during the baseline period on the measure specified under section
1888(g)(1) or (2) of the Act in the form of the achievement threshold--
median of all SNF performance during a baseline period--and the
benchmark--mean of the top decile of all SNF performance during a
baseline period. We could then consider awarding points along a
continuum relative to those performance levels.
(b) Hospital-Acquired Conditions Reduction Program
We also considered whether we should adopt any components of the
scoring methodology that we have finalized for the HAC Reduction
Program under the SNF VBP Program. The HAC Reduction Program requires
the Secretary to reduce eligible hospitals' Medicare payments to 99
percent of what would otherwise have been paid for discharges when
hospitals rank in the worst performing quartile for risk-adjusted HAC
quality measures. These quality measures comprise efforts to promote
quality of care by reducing the number of HACs in the acute inpatient
hospital setting.
We determine a hospital's Total HAC Score by first assigning each
hospital a score of between 1 and 10 for each measure based on the
hospital's relative performance ranking in 10 groups (or deciles) for
that measure. Second, the measure score is used to calculate the domain
score. We discuss other details of the HAC Reduction Program's scoring
methodology in further detail in this section.
Although the HACRP statutory authority is not structured the same
as the SNF VBP statutory authority, we view the HACRP's use of decile-
based performance standards as one conceptual possibility for
constructing performance standards under the SNF VBP Program.
Specifically, we could consider setting performance standards based on
SNFs' ranked performance on the measures specified under sections
1888(g)(1) or (2) of the Act during the performance period. We could
divide SNFs' performance on the measures into deciles and award between
1 and 10 points to all SNFs within each decile. While this type of
performance standards calculation would measure and reward achievement,
we are concerned that it would not incorporate improvement, and we
invited comment on the best means by which we could include improvement
in this type of calculation.
(c) Hospital Readmissions Reduction Program (HRRP)
We also considered aspects of the Hospital Readmissions Reduction
Program (HRRP) for adaptation under the SNF VBP Program. HRRP reduces
Medicare payments to hospitals with a higher number of readmissions for
applicable conditions over a specified time period.
Hospital readmissions are defined as Medicare patients who are
readmitted to the same or another hospital within 30 days of a
discharge from the same or another hospital, which includes short-term
inpatient acute care hospitals. The initial hospital inpatient
admission (the discharge from which starts the 30-day potential penalty
clock) is termed the index admission. The hospital inpatient
readmission (which can be used to determine application of a penalty if
the readmission occurs within 30 days of the index inpatient admission
stay) can be for any cause, that is, it does not have to be for the
same cause as the index admission.
Using historical data, we determine whether eligible IPPS hospitals
have readmission rates that are higher than expected, given the
hospital's case mix, while accounting for the patient risk factors,
including age, and chronic medical conditions identified from inpatient
and outpatient claims for the 12 months prior to the hospitalization. A
hospital's excess readmission ratio for each condition is a measure of
a hospital's readmission performance compared to the national average
for the hospital's set of patients with that applicable condition. If
the hospital's actual readmission rate, based on the hospital's actual
performance, for the year is greater than its CMS-expected readmission
rate, the hospital incurs a penalty up to the maximum cap. If a
hospital performs better than an average hospital that admitted similar
patients, the hospital will not be subjected to a payment reduction. If
a hospital performs worse than average (below a 1.000 score), the
poorer performance triggers a payment reduction. For FY 2013, the
reduction was capped at 1 percent, for FY 2014 at 2 percent, and at 3
percent for FY 2015 and for subsequent years.
We view the Hospital Readmissions Reduction Program as a potential
model for the SNF VBP Program because that program does not weight
scores based on domains. That is, under the HRRP, hospitals' risk-
adjusted readmissions ratios form the basis for Medicare payment
adjustments. Under SNF VBP (and as discussed further in this section),
the Program's statute requires us to select only one measure to form
the basis for the SNF Performance Score. We believe that this
conceptual similarity stands distinct from certain other CMS quality
programs that incorporate quality measurement domains and domain
weighting into the scoring calculations. However, the HRRP sets an
effective performance standard based on the average readmissions
adjustment factor of 1.000. We invited comment on whether we should
adopt a similar form of performance standard under the SNF VBP Program.
This performance standard could take the form of the median or mean
performance on the specified quality measure during the performance
period. However, we believe we would also need to consider more
granular delineations in SNF scoring to ensure an appropriate
distribution of value-based incentive payments under the Program, and
we invited comment on what additional policies we should consider
adopting in this topic area.
(d) End-Stage Renal Disease Quality Incentive Program (ESRD QIP)
The ESRD QIP is authorized by section 1881(h) of the Act. The
program promotes patient health by providing a financial incentive for
renal dialysis facilities to deliver high-quality care to their
patients.
Section 1881(h)(3)(A)(i) of the Act requires the Secretary to
develop a methodology for assessing the total performance of each
provider and facility based on performance standards. For each clinical
measure adopted under the ESRD QIP, we assess
[[Page 46421]]
performance on both achievement and improvement. For the achievement
score, facility performance on a measure during a performance period is
compared against national facility performance on that measure during a
specified baseline period. To calculate the improvement score, we
compare a facility's performance during the performance period to its
performance during a specified baseline period. In determining a
clinical measure score for each measure, we take the higher of the
improvement or achievement score.
For each reporting measure, we assess performance based on whether
the facility completed the reporting for that measure as specified. If
a facility reports data according to the specifications we have
adopted, then the facility earns the maximum number of points on the
measure. If the facility partially reports data according to the
specifications we have adopted, the hospital earns some points on the
measure, but less than the maximum.
We believe that the ESRD QIP performance standards methodology is a
well-understood methodology under which health care providers and
suppliers can be rewarded both for providing high-quality care and for
improving their performance over time. The scoring methodology rewards
achievement and improvement, and is generally aligned with other pay-
for-performance and QRPs. Like the Hospital VBP Program statutory
language, the ESRD QIP statutory language is structured similar to the
SNF VBP Program statutory language, and we are considering adoption of
a similar methodology for calculating performance standards under the
SNF VBP Program. Specifically, we could consider adopting performance
standards based on all SNF performance during the baseline period on
the measure specified under sections 1888(g)(1) or (2) of the Act in
the forms of the achievement threshold--median of all SNF performance--
and the benchmark--mean of the top decile of all SNF performance. We
could then consider awarding points for those performance levels.
A discussion of the comments that we received on potential
approaches to calculating performance standards, and our responses to
those comments, appears below.
Comment: One commenter suggested that we reconsider using the
``higher of'' achievement and improvement requirement when determining
the performance score and we should focus the SNF VBP Program on having
all providers furnish high quality of care.
Response: We do not believe we have the authority to reconsider
using the ``higher of'' achievement and improvement requirement given
the statutory requirement in section 1888(h)(3)(B) of the Act, which
requires us to adopt performance standards that include levels of
achievement and improvement, and further directs us to use the higher
of either improvement or achievement in calculating the SNF performance
score under paragraph (4).
Comment: Commenters urged us to establish performance standards
prior to the beginning of the performance period, as we do in the
Hospital VBP Program. Commenters stated that this policy enables
providers to understand in advance what level of performance they must
reach under the Program.
Response: We intend to establish and announce performance standards
in advance of the performance period in accordance with the requirement
in section 1888(h)(3)(C) of the Act.
We will consider these comments further in future rulemaking.
(2) Measuring Improvement
We are considering several methodologies for improvement scoring
under the SNF VBP Program, and we invited public comments on these
options or others that we should consider as we develop our SNF VBP
Program policies for future rulemaking.
Section 1888(h)(4)(B) of the Act specifically requires us to
construct a ranking of SNF performance scores. While we view such a
ranking system as fairly straightforward when based on achievement
scoring--for example, ranking SNFs based on their performance on a
measure during the performance period could be achieved by ordering SNF
performance rates on the measure specified for the Program year--we are
considering several approaches for including improvement in the SNF
scoring methodology because we are limited to one measure for each SNF
Program year. These approaches include:
Improvement points, awarded using a similar methodology as
the one we use to award improvement points in the Hospital VBP Program.
Measure rate increases, in which a SNF's performance rate
on a measure would be increased as a result of its improvement over
time.
Ranking increases, in which a SNF's ranking relative to
other SNFs would be increased as a result of improvement.
Performance score increases, in which a SNF's performance
score would be increased as a result of improvement.
We discuss each of these options in further detail in the FY 2016
SNF PPS proposed rule (80 FR 22063 through 22064).
The comments we received on this topic, along with their responses,
appear below.
Comment: Commenters stated that we should not adjust SNFs' measure
rates directly to reward improvement, cautioning that making those
types of adjustments could make valid comparisons of SNF performance
more difficult.
Response: We thank the commenters for this feedback.
Comment: Some commenters did not believe that improvement
measurement should apply to providers in the top quartile of SNFRM
performance. Commenters supported recognizing improvement efforts, but
believed that the top quartile should recognize top performers.
Response: We thank the commenters for this feedback, and we will
take it into account as we develop our performance standards policy
proposals in the future.
Comment: One commenter suggested that we not adopt an achievement
threshold under the SNF VBP Program to ensure that all SNFs may qualify
for points. The commenter also suggested that we place equal emphasis
on improvement under the program, and noted that the Hospital VBP
Program separately calculates achievement and improvement and awards
the higher of the two to participating hospitals.
Response: We thank the commenter for this feedback, and we will
take it into account as we develop our performance standards policy
proposals in the future.
Comment: One commenter urged us not to set an absolute level of
performance to which SNFs would have to aspire to receive points. The
commenter stated that adopting performance standards in this manner
would disincentivize improvement, as some SNFs would be unable to
receive value-based incentive payments.
Response: We thank the commenter for this feedback, and will
consider it in the future.
Comment: One commenter requested that we solicit public comments on
performance standards, performance scoring, and the exchange function
after releasing detailed analysis of the various options, as well as
performance data on the SNFRM.
Response: We thank the commenter for this feedback. We intend to
provide as much information as possible on our proposals for this
Program in the future.
[[Page 46422]]
Comment: One commenter recommended that we award points to SNFs for
achievement and improvement, but ensure that low-performing SNFs that
improve are not ranked higher than high-performing SNFs.
Response: We thank the commenter for this feedback and will take it
into account when developing our proposals in the future.
We will consider these comments further in future rulemaking.
e. FY 2019 Performance Period and Baseline Period Considerations
(1) Performance Period
We intended to specify a performance period for a payment year
close to the payment year's start date. We strive to link performance
furnished by SNFs as closely as possible to the payment year to ensure
clear connections between quality measurement and value-based payment.
We also strive to measure performance using a sufficiently reliable
population of patients that broadly represent the total care provided
by SNFs. As such, we anticipate that our annual performance period end
date must provide sufficient time for SNFs to submit claims for the
patients included in our measure population. In other programs, such as
HRRP and the Hospital Inpatient Quality Reporting Program (HIQR), this
time lag between care delivered to patients who are included in the
readmission measures and application of a payment consequence linked to
reporting or performance on those measures has historically been close
to 1 year. We also recognize that other factors contribute to this time
lag, including the processing time we need to calculate measure rates
using multiple sources of claims needed for statistical modeling, time
for providers to review their measure rates and included patients, and
processing time we need to determine whether a payment adjustment needs
to be made to a provider's reimbursement rate under the applicable PPS
based on its reporting or performance on measures.
For the FY 2019 SNF VBP Program's performance period, we are also
considering the necessary timeline we need to complete measure scoring
to announce the net result of the Program's adjustments to Medicare
payments not later than 60 days prior to the FY, in accordance with
section 1888(h)(7) of the Act. We are also considering the number of
SNF stays typically covered by Medicare each year. As discussed
previously, Medicare typically covers more than 2 million Medicare Part
A stays per year in more than 15,000 SNFs. Therefore, we believe that 1
year of SNFRM data is sufficient to ensure that the measure rates are
statistically reliable.
We intended to propose a performance period for the FY 2019 SNF VBP
Program in future rulemaking. We invited public comment on the most
appropriate performance period length. The comments we received on this
topic, with their responses, appear below.
Comment: Commenters supported a one-year performance period, and
suggested that we also consider establishing a minimum annual case
count which data from multiple years could be pooled to create more
statistically-reliable measure scores.
Response: We thank the commenters for their support. We will
consider whether we should establish a minimum annual case count for
the SNFRM in future rulemaking.
We will consider these comments further in future rulemaking.
(2) Baseline Period
As described previously, in other Medicare quality programs such as
the Hospital VBP Program and the ESRD Quality Incentive Program, we
generally adopt a baseline period that occurs prior to the performance
period for a FY to measure improvement and establish performance
standards.
We view the SNF VBP Program as necessitating a similarly-adopted
baseline period for each FY to measure improvement (as required by
section 1888(h)(3)(B) of the Act) and to enable us to calculate
performance standards that we must establish and announce prior to the
performance period (as required by section 1888(h)(3)(A) of the Act).
As with the Hospital VBP Program, we intend to adopt baseline periods
that are as close as possible in duration as the performance period
specified for a FY. However, we may occasionally need to adopt a
baseline period that is shorter than the performance period to meet
operational timelines. We also intended to adopt baseline periods that
are seasonally aligned with the performance periods to avoid any
effects on quality measurement that may result from tracking SNF
performance during different times of the calendar year.
We stated our intent to propose a baseline period for purposes of
calculating performance standards and measuring improvement in future
rulemaking. We invited public comment on the most appropriate baseline
period for the FY 2019 Program, including what considerations we should
take into account when developing this policy for future rulemaking.
The comments we received on this topic, with their responses, appear
below.
Comment: Commenters supported our proposal to adopt a 12-month
baseline period for purposes of quality measurement. Some commenters
suggested that we test longer time periods, however, to see whether
more time improves the measure's variation. Commenters further
suggested that we align the baseline and performance periods under the
SNF VBP Program to the calendar year.
Response: We thank the commenters for their support. We will
consider testing longer time periods in the future.
We will consider these comments further in future rulemaking.
f. SNF Performance Scoring
(1) Considerations
As with our performance standards policy considerations described
above, we considered how other Medicare quality programs score eligible
facilities. Specifically, we considered how the Hospital VBP Program
and the Hospital-Acquired Conditions Reduction Program score eligible
hospitals. We discussed the Hospital Readmissions Reduction Program's
scoring above in relation to performance standards.
(a) Hospital Value-Based Purchasing
A Hospital VBP domain score is calculated by combining the measure
scores within that domain, weighting each measure equally. The domain
score reflects the number of points the hospital has earned based on
its performance on the measures within that domain for which it is
eligible to receive a score. After summing the weighted domain scores,
the TPS is translated using a linear exchange function into the
percentage multiplier to be applied to each Medicare discharge claim
submitted by the hospital during the applicable FY. (We discuss the
Exchange Function in further detail below).
Unlike the Hospital VBP Program, the SNF VBP program focuses on a
single readmission measure, one that will be replaced by a single
resource use measure as soon as is practicable. As described above, we
do not anticipate adopting quality measure domains akin to other CMS
quality programs under the SNF VBP Program. We therefore invited
comment on how, if at all, we should adapt the HVBP Program's scoring
methodology to accommodate both the smaller number of measures and the
ranking required under the SNF VBP Program. We responded to comments on
this topic below.
[[Page 46423]]
(b) Hospital-Acquired Conditions Reduction Program
The Hospital-Acquired Conditions (HAC) Reduction Program scores
measures that have been categorized into domains, in a manner that is
similar to the HVBP Program's domain structure. For Domain 1, the
points awarded to the single assigned measure yield the Domain 1 score,
since Domain 1 only contains one measure. For Domain 2, the points
awarded for the domain measures are averaged to yield a Domain 2 score.
A hospital's Total HAC Score is determined by the sum of weighted
Domain 1 and Domain 2 scores. Higher scores indicate worse performance
relative to the performance of all other eligible hospitals. Hospitals
with a Total HAC Score above the 75th percentile of the Total HAC Score
distribution are subject to a payment reduction.
Unlike the Hospital VBP program, referenced above, there is no
requirement in the HAC Reduction Program that measures or performance
standards must incorporate improvement and achievement scores. As with
the HVBP Program above, we invited public comments on the extent to
which, if at all, we should adopt components of the HAC Reduction
Program's scoring methodology for purposes of the SNF VBP Program. We
specifically invited comments on whether we should set an absolute
level of performance that must be reached to receive a positive SNF
value-based incentive payment. We responded to comments on this topic
below.
(c) Other Considerations
We stated our intention to consider several additional factors when
developing the performance scoring methodology. We believe that it is
important to ensure that the performance scoring methodology is
straightforward and transparent to SNFs, patients, and other
stakeholders. SNFs must be able to clearly understand performance
scoring methods and performance expectations to maximize their quality
improvement efforts. The public must understand the scoring methodology
to make the best use of the publicly reported information when choosing
a SNF. We also believe that scoring methodologies for all Medicare VBP
programs should be aligned as appropriate given their specific
statutory requirements. This alignment will facilitate the public's
understanding of quality information disseminated in these programs and
foster more informed consumer decision making about health care. We
believe that differences in performance scores must reflect true
differences in performance. To ensure that these beliefs are
appropriately reflected in the SNF VBP Program, we stated our intention
to assess the quantitative characteristics of the measures specified
under sections 1888(g)(1) and (2) of the Act, including the current
state of measure development, to ensure an appropriate distribution of
value-based incentive payments as required by the SNF VBP statute.
We invited public comment on what other considerations we should
take into account when developing our proposed scoring methodology for
the SNF VBP Program in future rulemaking. The comments we received on
this topic, as well as all other comments on considerations we should
take into account when developing the SNF VBP Program's scoring
methodology, along with their responses, appear below.
Comment: Some commenters agreed that adapting the Hospital VBP
Program's scoring methodology is advantageous for the SNF VBP Program
because it is well-understood and tested. Other commenters noted that
we have substantial experience with this type of approach and stated
that this approach provides the strongest incentive for all SNFs to
improve their performance.
Response: We thank the commenters for their support and will take
this feedback into account when developing our proposals in the future.
Comment: One commenter provided general suggestions for us as we
develop the SNF VBP Program's scoring methodology, including the
beliefs that the methodology should be easy to understand and that we
should provide education to SNFs in the first years of the program. The
commenter also expressed support for public reporting of SNF
performance scores and quality measure performance, and suggested that
we provide regular feedback to SNFs prior to publication.
Response: We thank the commenters for the feedback and support. We
will take these recommendations into account in future rulemaking.
Comment: One commenter outlined several principles for our
consideration while designing the SNF VBP Program, including aligning
incentives, involving stakeholders, focusing on improving quality
instead of cost-cutting, providing rewards that motivate change,
implementing the program incrementally, rewarding both high levels of
performance and substantial improvements, using measures developed in
an open, consensus-based manner, including evidence-based measures, and
designing the program to avoid perpetuating care disparities.
Response: We thank the commenter for the feedback and will take it
into account when developing our proposals in the future.
Comment: One commenter urged us to continue engaging stakeholders
in discussions on the SNF VBP Program's design, particularly given the
commenter's opinion that the program is more characteristic of a
penalty program than an incentive program.
Response: We disagree with the commenter's characterization of the
Program as a ``penalty program.'' The SNF VBP Program is designed to
reward SNFs based on their quality performance, whether accomplished
through achievement or improvement over time.
Comment: One commenter urged us to consider the variations in the
types and intensity of SNF-based care when developing performance
standards and the ranking for the SNF VBP Program, stating that we
should distinguish between primarily short-term, transitional care and
medically complex, longer-term patients. The commenter suggested that
we consider adopting a similar policy to the long-term care hospital
interrupted stay policy for the SNF PPS to ensure that facilities are
not provided with incentives to withhold medically necessarily care for
fear of loss of significant revenue.
Response: The SNFRM, which was endorsed by the NQF, has been risk
adjusted for case-mix to account for differences in patient
populations. The goal of risk adjustment is to account for these
differences so that providers who treat sicker or more vulnerable
patient populations are not unnecessarily penalized. The current
measure accounts for all of the factors proposed in the comment above,
including the following: principal diagnosis from the Medicare claim
corresponding to the prior proximal hospitalization as categorized by
AHRQ's CCS groupings, length of stay during the patient's prior
proximal hospitalization, length of stay in the ICU, ESRD status,
whether the patient was disabled, the number of prior hospitalizations
in the previous 365 days, system-specific surgical indicators,
individual comorbidities as grouped by CMS's HCC or other comorbidity
indices, and a variable counting the number of comorbidities if the
patient had more than two HCCs. However, as discussed above, this
measure does not currently adjust for beneficiaries that are dually
eligible in Medicare and Medicaid. Based on the results of the NQF
trial period for risk-
[[Page 46424]]
adjustment for socioeconomic status, as well as work being conducted on
this issue by ASPE, the measure specifications may be revised to
include additional risk adjusters in the future related to
socioeconomic status or sociodemographics.
Comment: One commenter suggested that we conduct data analyses to
determine whether different measures or scoring should be applied to
hospital-based and freestanding SNFs.
Response: We thank the commenter for this feedback and will
consider whether this type of adjustment is appropriate in the future.
Comment: One commenter suggested that we modify the ESRD QIP's
scoring methodology for adoption under the SNF VBP Program. The
commenter stated that the other models described in the proposed rule
do not meet the Program's statutory requirements.
Response: We thank the commenter for this feedback. We intend to
ensure that any proposed scoring methodology under the SNF VBP Program
complies fully with applicable statutory requirements.
We will consider these comments further in future rulemaking.
(2) Notification Procedures
As described above, we stated our intention to address the topic of
quarterly feedback reports to SNFs related to measures specified under
sections 1888(g)(1) and (2) of the Act in future rulemaking. We also
stated that we intend to address how to notify SNFs of the adjustments
to their PPS payments based on their performance scores and ranking
under the SNF VBP Program, in accordance with the requirement in
section 1888(h)(7) of the Act, in future rulemaking.
We invited public comment on the best means by which to so notify
SNFs. We responded to comments on this topic below in the ``SNF-
Specific Performance Information'' subsection.
(3) Exchange Function
As described above in reference to the Hospital VBP Program's
scoring methodology, we use a linear exchange function to translate a
hospital's Total Performance Score under that Program into the
percentage multiplier to be applied to each Medicare discharge claim
submitted by the hospital during the applicable FY. We refer readers to
the Hospital Inpatient VBP Program Final Rule (76 FR 26531 through
26534) for detailed discussion of the Hospital VBP Program's Exchange
Function, as well as responses to public comments on this issue.
We believe we could consider adopting a similar exchange function
methodology to translate SNF performance scores into value-based
incentive payments under the SNF VBP Program, and we invited comment on
whether we should do so. However, as we did for the Hospital VBP
Program, we believe we would need to consider the appropriate form and
slope of the exchange function to determine how best to reward high
performance and encourage SNFs to improve the quality of care provided
to Medicare beneficiaries. As illustrated in figure 1, we could
consider the following four mathematical exchange function options:
Straight line (linear); concave curve (cube root function); convex
curve (cube function); and S-shape (logistic function), and we seek
comment on what form of the exchange function we should consider
implementing if we adopt such a function under the SNF VBP Program.
[GRAPHIC] [TIFF OMITTED] TR04AU15.000
[[Page 46425]]
We also invited comment on what considerations we should take into
account when determining the appropriate form of the exchange function
under the SNF VBP Program. We stated our intention to consider how such
options would distribute the value-based incentive payments among SNFs,
the potential differences between the value-based incentive payment
amounts for SNFs that perform poorly and SNFs that perform very well,
the different marginal incentives created by the different exchange
function slopes, and the relative importance of having the exchange
function be as simple and straightforward as possible. We requested
public comments on what additional considerations, if any, we should
take into account. The comments we received on this topic, with their
responses, appear below.
Comment: One commenter expressed support for a linear exchange
function under the SNF VBP Program, stating that such a function is
easily understood by providers and may encourage practice pattern
changes more easily than a more complex function. Commenters also noted
that a linear exchange function gives equal importance to improvement
for lower- and higher-performing SNFs, and gives all providers an equal
opportunity to earn an incentive payment.
Response: We thank the commenter for the feedback on this topic. We
will take these recommendations into account in future rulemaking.
Comment: One commenter suggested that we adopt a logistic exchange
function and ensure that top-performing SNFs earn back more than 2
percent of their payments from the Program.
Response: We thank the commenter for the feedback on this topic. We
will take these recommendations into account in future rulemaking.
We will consider these comments further in future rulemaking.
g. SNF Value-Based Incentive Payments
Sections 1888(h)(5) and (6) of the Act outline several requirements
for value-based incentive payments under the SNF VBP Program, including
the value-based incentive payment percentage that must be determined
for each SNF and the funding available for value-based incentive
payments.
We stated our intention to address this topic in future rulemaking.
A discussion of the general comments that we received on the SNF Value-
Based incentive payments, and our responses to those comments, appears
below.
Comment: Commenters recommended that we distribute the maximum 70
percent of the funds withheld from participating SNF payments under the
SNF VBP Program to ensure that the program offers payment for value
instead of becoming a penalty program. Some commenters also suggested
that the remaining 30 percent of funds withheld be used to fund SNF
quality improvement initiatives. Other commenters requested that we
explain how the remaining 30-50 percent of funds will be used.
Response: We thank the commenters for this feedback. As the
commenters noted, section 1888(h)(5)(C)(ii)(III) of the Act requires
that the total amount of value-based incentive payments under the SNF
VBP Program for all SNFs in a fiscal year must be greater than or equal
to 50 percent, but not greater than 70 percent, of the total amount of
the reductions to the SNF PPS payments for that fiscal year, as
estimated by the Secretary. We do not believe we have the authority to
use the balance of funds that will remain after paying out value-based
incentive payments to SNFs under the Program for other SNF quality
improvement initiatives. We believe these funds are required to remain
in the Medicare Trust Fund.
We will consider these comments further in future rulemaking.
h. SNF VBP Public Reporting
(1) SNF-Specific Performance Information
Section 1888(h)(9)(A) of the Act requires the Secretary to post
information on the performance of individual SNFs under the SNF VBP
Program on the Nursing Home Compare Web site or its successor. This
information is to include the SNF performance score for the facility
for the applicable FY and the SNF's ranking for the performance period
for such FY.
We stated our intention to address this topic in future rulemaking.
We invited public comment on how we should display this SNF-specific
performance information, whether we should allow SNFs an opportunity to
review and correct the SNF-specific performance information that we
will post on Nursing Home Compare, and how such a review and correction
process should operate. The comments we received on this topic, with
their responses, appear below.
Comment: One commenter requested that SNFs have an opportunity to
review and correct their performance information prior to its posting
on Nursing Home Compare. Commenters requested that the information
furnished to SNFs for this purpose should incorporate sufficient detail
for SNFs to validate their performance and ranking. The commenters also
stated that any public reporting should include explanations of the
SNFRM's methodology, what the measure is intended to show, and any of
its limitations.
Response: We thank the commenters for this feedback. We will take
it into account as we develop our policies on posting SNF-specific
information in the future.
Comment: One commenter supported our intention to distribute
confidential feedback reports to SNFs via a secure portal. However, the
commenter suggested that we use QIES rather than QualityNet, as the
former is familiar to SNFs.
Response: We thank the commenter for this feedback, and will take
it into account in the future.
Comment: Other commenters suggested that we use the existing
mechanism, QIES, for providing SNFs feedback reports and access to
their quality measures as to provide quarterly performance reports. The
commenters noted that these reports should provide information on
performance relative to others and ranking relative to the payment
adjustment. Commenters requested that the reports include actual, non-
adjusted measures, predicted actual, expected rate, standardized RR,
risk adjusted rate, actual numerator, actual denominator, list of
patients in numerator, improvement score, achievement score,
performance score and performance rank.
Response: We thank the commenters for these suggestions. We will
provide details on infrastructure decisions such as this in future
rulemaking. We interpret the comment to indicate that it would be
useful for providers to receive from CMS readmission-related
information so that they can better understand why a given patient was
readmitted and for care-related improvement purposes. We support the
intent to seek information that will drive improved quality; however,
as described above, while we may provide information pertaining to a
patient's readmission episode, we cannot interpret such determinations
and readmission rationales, or provide post-discharge information. As
part of their quality improvement and care coordination efforts, SNFs
are encouraged to monitor hospital readmissions and follow up.
Therefore, although this measure will not provide specific information
at the patient level, we believe that SNFs will be able to monitor
their overall hospital readmission rates and assess their performance.
[[Page 46426]]
Comment: Commenters requested that we make claims available to
providers and others to calculate the SNFRM measure on an ongoing basis
(for example quarterly) such as we are doing by providing claims data
to the Bundled Payments for Care Improvement (BPCI) initiative
participants. Commenters also recommended that we make available Part A
claims on a much more frequent basis (for example, quarterly) so that
organizations, vendors, and other stakeholders can calculate the
rehospitalization rates for SNF patients and provide additional
analyses and profiling that can help SNFs with their quality
improvement efforts such as what is currently done with MDS data and
quality measures.
Response: We thank the commenters for these suggestions. We will
address data availability in future rulemaking.
We will consider these comments further in future rulemaking.
(2) Aggregate Performance Information
Section 1888(h)(9)(B) of the Act requires the Secretary to post
aggregate information on the SNF VBP Program on the Nursing Home
Compare Web site, or a successor Web site, to include the range of SNF
performance scores and the number of SNFs that received value-based
incentive payments and the range and total amount of such value-based
incentive payments.
We stated our intention to address this topic in future rulemaking.
We invited public comment on the most appropriate form for posting this
aggregate information to make such information easily understandable
for the public. The comments we received on this topic, with their
responses, appear below.
Comment: One commenter suggested that we combine aggregate
performance information with individual rehospitalization performance
scores and rankings when posting SNFs' performance information on
Nursing Home Compare. The commenter stated that the ranking and SNF
performance score alone will be confusing because they will combine
achievement and improvement.
Response: We thank the commenter for this feedback, and will take
it into account in the future rulemaking.
2. Advancing Health Information Exchange
HHS has a number of initiatives designed to encourage and support
the adoption of health information technology and to promote nationwide
health information exchange (HIE) to improve health care. As discussed
in the August 2013 Statement ``Principles and Strategies for
Accelerating Health Information Exchange'' (available at https://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf), HHS believes that all
individuals, their families, their healthcare and social service
providers, and payers should have consistent and timely access to
health information in a standardized format that can be securely
exchanged between the patient, providers, and others involved in the
individual's care. Health information technology (IT) that facilitates
the secure, efficient and effective sharing and use of health-related
information when and where it is needed is an important tool for
settings across the continuum of care, including SNFs and NFs. While
these facilities are not eligible for the Medicare and Medicaid EHR
Incentive Programs, effective adoption and use of health information
exchange and health IT tools will be essential as these settings seek
to improve quality and lower costs through initiatives such as VBP.
The Office of the National Coordinator for Health Information
Technology (ONC) has released a document entitled ``Connecting Health
and Care for the Nation: A Shared Nationwide Interoperability Roadmap
Draft Version 1.0 (draft Roadmap) (available at https://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf) which describes barriers to
interoperability across the current health IT landscape, the desired
future state that the industry believes will be necessary to enable a
learning health system, and a suggested path for moving from the
current state to the desired future state. In the near term, the draft
Roadmap focuses on actions that will enable a majority of individuals
and providers across the care continuum to send, receive, find and use
a common set of electronic clinical information at the nationwide level
by the end of 2017. The draft Roadmap's goals also align with the
IMPACT Act of 2014 which requires assessment data to be standardized
and interoperable to allow for exchange of the data. Moreover, the
vision described in the draft Roadmap significantly expands the types
of electronic health information, information sources and information
users well beyond clinical information derived from electronic health
records (EHRs). This shared strategy is intended to reflect important
actions that both public and private sector stakeholders can take to
enable nationwide interoperability of electronic health IT such as: (1)
Establishing a coordinated governance framework and process for
nationwide health IT interoperability; (2) improving technical
standards and implementation guidance for sharing and using a common
clinical data set; (3) enhancing incentives for sharing electronic
health information according to common technical standards, starting
with a common clinical data set; and (4) clarifying privacy and
security requirements that enable interoperability.
In addition, ONC has released the draft version of the 2015
Interoperability Standards Advisory (available at https://www.healthit.gov/standards-advisory), which provides a list of the best
available standards and implementation specifications to enable
priority health information exchange functions. Providers, payers, and
vendors are encouraged to take these ``best available standards'' into
account as they implement HIE across the continuum of care, including
care settings such as behavioral health, long-term and post-acute care,
and home and community-based service providers.
We encourage stakeholders to utilize HIE and certified health IT to
effectively and efficiently help providers improve internal care
delivery practices, support management of care across the continuum,
enable the reporting of electronically specified clinical quality
measures (eCQMs), and improve efficiencies and reduce unnecessary
costs. As adoption of certified health IT increases and
interoperability standards continue to mature, HHS will seek to
reinforce standards through relevant policies and programs.
The comments we received on this topic, with their responses,
appear below.
Comment: All of the comments received on this topic supported the
overall agency goal to accelerate HIE within SNFs, and among the post-
acute care providers generally. One commenter asked CMS to keep in mind
that certain types of clinicians, such as physical therapists, operate
in different provider settings. Another commenter urged CMS to consider
the potential impact of HIE regulations and policies on innovation and
business practices. Finally, one commenter urged CMS to provide the
same type of incentives and considerations to post-acute care providers
as they do in other areas with regard to accelerating HIE.
Response: We appreciate the broad support for this initiative and
the helpful suggestions provided by the commenters. We will share these
comments with the appropriate CMS staff and other governmental agencies
to ensure they are taken into account as we
[[Page 46427]]
continue to encourage adoption of health information technology.
3. SNF Quality Reporting Program (QRP)
a. Background and Statutory Authority
We seek to promote higher quality and more efficient health care
for Medicare beneficiaries, and our efforts are furthered by QRPs
coupled with public reporting of that information. Such QRPs already
exist for various settings such as the Hospital Inpatient Quality
Reporting (HIQR) Program, the Hospital Outpatient Quality Reporting
(HOQR) Program, the Physician Quality Reporting System, the Long-Term
Care Hospital (LTCH) QRP, the Inpatient Rehabilitation Facility (IRF)
QRP, the Home Health Quality Reporting Program (HHQRP), and the Hospice
Quality Reporting Program (HQRP). We have also implemented QRPs for
home health agencies (HHAs) that are based on conditions of
participation, and an ESRD QIP and a Hospital Value-Based Purchasing
(HVBP) Program that link payment to performance.
SNFs are providers that must meet conditions of participation for
Medicare to receive Medicare payments. Some SNFs are also certified
under Medicaid as nursing facilities (NFs), and these types of long-
term care facilities furnish services to both Medicare beneficiaries
and Medicaid enrollees. SNFs provide short-term skilled nursing
services, including but not limited to rehabilitative therapy, physical
therapy, occupational therapy, and speech-language pathology services.
Such services are provided to beneficiaries who are recovering from
surgical procedures, such as hip and knee replacements, or from medical
conditions, such as stroke and pneumonia. SNF services are provided
when needed to maintain or improve a beneficiary's current condition,
or to prevent a condition from worsening. The care provided in a SNF
(as a free-standing facility or part of a hospital), is aimed at
enabling the beneficiary to maintain or improve his/her health and to
function independently. SNF care is a benefit under Medicare Part A and
such care is covered for up to 100 days in a benefit period if all
coverage requirements are met.\15\ In 2014, 2.6 million covered
Medicare Part A stays occurred within 15,421 SNFs.
---------------------------------------------------------------------------
\15\ Section 1812(a)(2) and (b)(2) of the Act; 42 CFR 409.61;
https://www.medicare.gov/Pubs/pdf/10153.pdf.
---------------------------------------------------------------------------
Section 1888(e)(6)(B)(i)(II) of the Act requires that each SNF
submit, for FYs beginning on or after the specified application date
(as defined in section 1899B(a)(2)(E) of the Act), data on quality
measures specified under section 1899B(c)(1) of the Act and data on
resource use and other measures specified under section 1899B(d)(1) of
the Act in a manner and within the timeframes specified by the
Secretary. In addition, section 1888(e)(6)(B)(i)(III) of the Act
requires, for FYs beginning on or after October 1, 2018, that each SNF
submit standardized patient assessment data required under section
1899B(b)(1) of the Act in a manner and within the timeframes specified
by the Secretary. Section 1888(e)(6)(A)(i) of the Act requires that,
for FYs beginning with FY 2018, if a SNF does not submit data, as
applicable, on quality and resource use and other measures in
accordance with section 1888(e)(6)(B)(i)(II) of the Act and on
standardized patient assessment in accordance with section
1888(e)(6)(B)(i)(III) of the Act for such FY, the Secretary reduce the
market basket percentage described in section 1888(e)(5)(B)(ii) of the
Act by 2 percentage points.
The IMPACT Act adds section 1899B to the Act that imposes new data
reporting requirements for certain PAC providers, including SNFs.
Sections 1899B(c)(1) and 1899B(d)(1) of the Act collectively require
that the Secretary specify quality measures and resource use and other
measures with respect to certain domains not later than the specified
application date in section 1899B(a)(2)(E) of the Act that applies to
each measure domain and PAC provider setting. The IMPACT Act also
amends section 1886(e)(6) of the Act, to require the Secretary to
reduce the PPS payments to a SNF that does not submit the data required
in a form and manner, and at a time, specified by the Secretary.
Section 1886(e)(6)(A)(i) of the Act would require the Secretary in a FY
beginning with FY 2018 to reduce by 2 percentage points the market
basket percentage increase as adjusted by the productivity adjustment
for SNFs that do not submit the required data.
Under the SNF QRP, we proposed that the general timeline and
sequencing of measure implementation would occur as follows: (1)
Specification of measures; (2) proposal and finalization of measures
through notice-and-comment rulemaking; (3) SNF submission of data on
the adopted measures; analysis and processing of the submitted data;
(4) notification to SNFs regarding their quality reporting compliance
with respect to a particular FY; (5) review of any reconsideration
requests; and (6) imposition of a payment reduction in a particular FY
for failure to satisfactorily submit data with respect to that FY. We
also proposed that any payment reductions that are taken for a FY for
the QRP would begin approximately 1 year after the end of the data
submission period for that FY and approximately 2 years after we first
adopt the measure.
This timeline, which is similar in the other QRPs, reflects
operational and other practical constraints, including the time needed
to specify and adopt valid and reliable measures, collect the data, and
determine whether a SNF has complied with our quality reporting
requirements. It also takes into consideration our desire to give SNFs
enough notice of new data reporting obligations so that they are
prepared to start reporting the data in a timely fashion. Therefore, we
stated our intention to follow the same timing and sequence of events
for measures specified under section 1899B(c)(1) and (d)(1) of the Act
that we currently follow for the other QRPs. We stated our intention to
specify each of these measures no later than the specified application
dates set forth in section 1899B(a)(2)(E) of the Act and proposed to
adopt them consistent with the requirements in the Act and
Administrative Procedure Act. To the extent that we finalize to adopt a
measure for the SNF QRP that satisfies an IMPACT Act measure domain, we
stated our intention to require SNFs to report data on the measure for
the FY that begins 2 years after the specified application date for
that measure. Likewise, we stated our intention to require SNFs to
begin reporting any other data specifically required under the IMPACT
Act for the FY that begins 2 years after we adopt requirements that
would govern the submission of that data.
We received multiple public comments pertaining to the general
timeline and plan for implementation of the IMPACT Act, sequencing of
measure implementation, standardization of PAC assessment tools, and
timing of payment consequences for the failure to comply with reporting
requirements. The following is a summary of the comments received on
this topic and our responses.
Comment: We received several comments regarding the timing of the
development of the IMPACT Act measures, the development of associated
data elements, data collection and reporting. One commenter noted the
considerable time constraints under which the Secretary is required to
implement the provisions of the IMPACT Act. Several commenters
requested that CMS communicate estimated implementation timelines for
all data collection and reporting
[[Page 46428]]
requirements. One commenter requested that CMS provide more detailed
information in the rule regarding multiple topics, including the
replacement of existing data elements in the PAC assessment tools with
a suggested common assessment tool, endorsement of quality measures,
and the sequence and timeline of events for measure implementation.
Response: We appreciate the public's feedback regarding the timing
issues related to IMPACT Act implementation. We recognize the need for
transparency as we move forward to implement the provisions of the
IMPACT Act and we intend to continue to engage stakeholders and ensure
that our approach to implementation and timing is communicated in an
open and informative manner. We will use the rulemaking process to
communicate timelines for implementation, including timelines for the
replacement of items in PAC assessment tools, timelines for
implementation of new or revised quality measures and timelines for
public reporting. We will also provide information through pre-
rulemaking activities surrounding the development of quality measures,
which includes public input as part of our process. Additionally, we
intend to engage stakeholders and experts in developing the assessment
instrument modifications necessary to meet data standardization
requirements of the IMPACT Act.
We will also continue to provide information about measures at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html.
Comment: We received several comments requesting the development of
a comprehensive overall plan for implementation across all settings
covered by the IMPACT Act. Commenters stated that a comprehensive
implementation plan would give PAC providers an opportunity to plan for
the potential impacts on their operations, and enable all stakeholders
to understand CMS's approach to implementing the IMPACT Act across care
settings. One commenter requested that CMS plans be communicated as
soon as possible and that CMS develop setting-specific communications
to facilitate understanding of the IMPACT Act requirements.
Response: We appreciate the request for a comprehensive plan to
allow PAC providers to plan for implementation of the IMPACT Act, as
well as the need for stakeholder input, the development of reliable,
accurate measures, clarity on the level of standardization of items and
measures, and avoidance of unnecessary burden on PAC providers. Our
intent has been to comply with these principles in the implementation
and rollout of QRPs in the various care settings, and we will continue
to adhere to these principles as the agency moves forward with
implementing IMPACT Act requirements.
In addition, in implementing the IMPACT Act requirements, we will
follow the strategy for identifying cross-cutting measures, timelines
for data collection and timelines for reporting as outlined in the
IMPACT Act. As described more fully above, the IMPACT Act requires CMS
to specify measures that relate to at least five stated quality domains
and three stated resource use and other measure domains. The IMPACT Act
also outlines timelines for data collection and timelines for
reporting. In addition, we must follow all processes in place for
adoption of measures including the MAP and the notice and comment
rulemaking process. In our selection and specification of measures, we
employ a transparent process in which we seek input from stakeholders
and national experts and engage in a process that allows for pre-
rulemaking input on each measure, as required by section 1890A of the
Act. This process is based on a private-public partnership, and it
occurs via the MAP. The MAP is composed of multi-stakeholder groups
convened by the NQF, our current contractor under section 1890 of the
Act, to provide input on the selection of quality and efficiency
measures described in section 1890(b)(7)(B). The NQF must convene these
stakeholders and provide us with the stakeholders' input on the
selection of such measures. We, in turn, must take this input into
consideration in selecting such measures. In addition, the Secretary
must make available to the public by December 1 of each year a list of
such measures that the Secretary is considering under Title XVIII of
the Act. Additionally, proposed measures and specifications are to be
announced through the Notice of Proposed Rulemaking (NPRM) process in
which proposed rules are published in the Federal Register and are
available for public view and comment.
Comment: We received several comments about the level of
standardization of data collection instruments across PAC settings as
required by the IMPACT Act. Commenters noted the importance of
standardized resident assessment data for cross-setting comparisons of
patient outcomes. Some commenters recognized the need to have as much
standardization of measures and data collection across PAC settings as
possible, while recognizing that some variations among settings may be
necessary. Those commenters cautioned that complete standardization of
PAC data may not be possible and urged CMS to consider standardization
around topics or domains but allowing different settings to use
assessment instruments that were most appropriate for the patient
populations assessed. One commenter requested that the specific items
added to achieve standardization to the Minimum Data Set (MDS) for NFs,
the Outcome and Assessment Information Set (OASIS) for home healthcare,
the Inpatient Rehabilitation Facility Patient Assessment Instrument
(IRF PAI), and Long-Term Care Hospitals Continuity Assessment Record
and Evaluation data set (LTCH-CARE) be published for comments.
Response: We agree that standardization is important for data
comparability and outcome analysis. The IMPACT Act requires the
modification of the assessment instruments to include standardized data
for multiple purposes including quality reporting, interoperability and
data comparison, and we will work to ensure that items pertaining to
measures required under the IMPACT Act that are used in assessment
instruments are standardized. We agree that there may be instances
where such data is not necessary or applicable to all four of the post-
acute settings' assessment instruments, but is used in more than one
assessment instrument. In that circumstance, we work to ensure that
such data is standardized.
With regard to the commenter's suggestion that a common assessment
tool be developed for PAC settings, we wish to clarify that while the
IMPACT Act requires the modification of PAC assessment instruments to
revise or replace certain existing patient assessment data with
standardized patient assessment data as soon as practicable, it does
not require a single data collection tool. We intend to modify the
existing PAC assessment instruments as soon as practicable to ensure
the collection of standardized data. While we agree that it is possible
that within the PAC assessment instruments certain sections could
incorporate a standardized assessment data collection tool, for
example, the Brief Interview for Mental Status (BIMS), we have not yet
concluded that this kind of modification of the PAC assessment
instruments is necessary.
All proposed and finalized changes to the PAC instruments are, and
will
[[Page 46429]]
continue to be, published on the applicable CMS Web sites. As
previously mentioned, it is our intention to develop such
standardization through clinical and expert input as well as
stakeholder and public engagement where we would receive input.
Comment: We received many comments about the burden on PAC
providers of meeting new requirements imposed as a result of the
implementation of the IMPACT Act. Commenters requested that CMS
consider minimizing the burden for PAC providers when possible and
avoid duplication in data collection.
Response: We appreciate the importance of avoiding undue burden and
will continue to evaluate and consider any burden the IMPACT Act and
the SNF QRP places on SNFs. In implementing the IMPACT Act thus far, we
have taken into consideration the new burden that our requirements
place on PAC providers, and we believe that standardizing patient
assessment data will allow for the exchange of data among PAC providers
in order to facilitate care coordination and improve patient outcomes.
Comment: We received one comment requesting that, in the future,
cross-setting measures and assessment data changes related to the
IMPACT Act be addressed in one stand-alone notice and rule that applies
to all four post-acute care settings.
Response: We will take this suggestion under consideration.
Comment: One commenter expressed support for the reduction of a
SNF's annual update by 2 percentage points for failure to report the
required quality data. Additionally, this commenter recommends that
imposition of the financial penalty should be published on a public
reporting Web site.
Response: We thank the commenter for its support of the SNF QRP
reduction as mandated by the IMPACT Act, and the suggestion to
publicize payment consequences imposed upon SNFs for failure to
satisfactorily report quality data. We will take this under
consideration.
Final Decision: After consideration of the public comments
received, we are finalizing the adoption of general timeline and
sequencing of measure implementation and that any payment reductions
that are taken with respect to a FY would begin approximately 1 year
after the end of the data submission period for that FY and
approximately 2 years after we first adopt the measure as proposed for
the SNF QRP.
As provided at section 1888(e)(6)(A)(ii) of the Act, depending on
the market basket percentage for a particular year, the 2 percentage
point reduction under section 1888(e)(6)(A)(i) of the Act may result in
this percentage, after application of the productivity adjustment under
section 1888(e)(5)(B)(ii) of the Act, being less than 0.0 percent for a
FY and may result in payment rates under the SNF PPS being less than
payment rates for the preceding FY. In addition, as set forth at
section 1888(e)(6)(A)(iii) of the Act, any reduction based on failure
to comply with the SNF QRP reporting requirements applies only to the
particular FY involved, and any such reduction must not be taken into
account in computing the SNF PPS payment rates for subsequent FYs.
For purposes of meeting the reporting requirements under the SNF
QRP, section 1888(e)(6)(B)(ii) of the Act states that SNFs or other
facilities described in section 1888(e)(7)(B) of the Act (other than a
CAH) may submit the resident assessment data required under section
1819(b)(3) of the Act using the standard instrument designated by the
state under section 1819(e)(5) of the Act. Currently, the resident
assessment instrument is titled the MDS 3.0. To the extent data
required for submission under subclause (II) or (III) of section
1888(e)(6)(B)(i) of the Act duplicates other data required to be
submitted under clause (i)(I), section 1888(e)(6)(B)(iii) provides that
the submission of data under subclause (II) or (III) is to be in lieu
of the submission of such data under clause (I), unless the Secretary
makes a determination that such duplication is necessary to avoid delay
in the implementation of section 1899B of the Act taking into account
the different specified application dates under section 1899B(a)(2)(E)
of the Act.
In addition to requiring a QRP for SNFs under new section
1888(e)(6), the IMPACT Act requires feedback to SNFs and public
reporting of their performance. More specifically, section 1899B(f)(1)
of the Act requires the Secretary to provide confidential feedback
reports to SNFs on their performance on the quality measures and
resource use and other measures specified under that section. The
Secretary must make such confidential feedback reports available to
SNFs beginning 1 year after the specified application date that applies
to the measures in that section and, to the extent feasible, no less
frequently than on a quarterly basis, except in the case of measures
reported on an annual basis, as to which the confidential feedback
reports may be made available annually.
Section 1899B(g)(1) of the Act requires the Secretary to provide
for the public reporting of SNF performance on the quality measures
specified under section 1899B(c)(1) of the Act and the resource use and
other measures specified under section 1899B(d)(1) of the Act by
establishing procedures for making the performance data available to
the public. Such procedures must ensure, including through a process
consistent with the process applied under section
1886(b)(3)(B)(viii)(VII) of the Act, that SNFs have the opportunity to
review and submit corrections to the data and other information before
it is made public as required by section 1899B(g)(2) of the Act.
Section 1899B(g)(3) of the Act requires that the data and information
is made publicly available beginning no later than 2 years after the
specified application date applicable to such a measure and SNFs.
Finally, section 1899B(g)(4)(B) of the Act requires that such
procedures must provide that the data and information described in
section 1899B(g)(1) of the Act for quality and resource use measures be
made publicly available consistent with sections 1819(i) and 1919(i) of
the Act.
b. General Considerations Used for Selection of Quality Measures for
the SNF QRP
We strive to promote high quality and efficiency in the delivery of
health care to the beneficiaries we serve. Performance improvement
leading to the highest quality health care requires continuous
evaluation to identify and address performance gaps and reduce the
unintended consequences that may arise in treating a large, vulnerable,
and aging population. QRPs, coupled with public reporting of quality
information, are critical to the advancement of health care quality
improvement efforts.
Valid, reliable, relevant quality measures are fundamental to the
effectiveness of our QRPs. Therefore, selection of quality measures is
a priority for CMS in all of its QRPs.
We proposed to adopt for the SNF QRP three measures that we are
specifying under section 1899(B)(c)(1) of the Act for purposes of
meeting the following three domains: (1) Functional status, cognitive
function, and changes in function and cognitive function; (2) skin
integrity and changes in skin integrity; and (3) incidence of major
falls. These measures align with the CMS Quality Strategy,\16\ which
[[Page 46430]]
incorporates the three broad aims of the National Quality Strategy:
\17\
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\16\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html.
\17\ https://www.ahrq.gov/workingforquality/nqs/nqs2011annlrpt.htm.
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Better Care: Improve the overall quality of care by making
healthcare more patient-centered, reliable, accessible, and safe.
Healthy People, Healthy Communities: Improve the health of
the U.S. population by supporting proven interventions to address
behavioral, social, and environmental determinants of health in
addition to delivering higher-quality care.
Affordable Care: Reduce the cost of quality healthcare for
individuals, families, employers, and government.
In deciding to propose these measures, we also took into account
national priorities, including those established by the National
Priorities Partnership (https://www.qualityforum.org/Setting_Priorities/NPP/National_Priorities_Partnership.aspx), and the HHS Strategic Plan
(https://www.hhs.gov/secretary/about/priorities/priorities.html).
These measures also incorporate common standards and definitions
that can be used across post-acute care settings to allow for the
exchange of data among post-acute care providers, to provide access to
longitudinal information for such providers to facilitate coordinated
and improved outcomes, and to enable comparison of such assessment data
across all such providers as required by section 1899B(a) of the Act.
We received comments on the topic of the General Considerations
Used for Selection of Quality Measures for the SNF QRP. The following
is a summary of the comments received and our responses.
Comment: One commenter expressed support for the goals and
principles outlined to improve quality and help guide the selection and
specification of measures in the SNF QRP.
Response: We appreciate the support.
Comment: While we received some comments expressing appreciation
for opportunities for stakeholder feedback regarding implementation of
the IMPACT Act, we also received several comments regarding the need
for more opportunities for stakeholder input into various aspects of
the measure development process. Commenters requested opportunities to
provide early and ongoing input into measure development. One commenter
requested opportunities for input prior to the development of proposed
measure specifications. Commenters requested that CMS hold meetings
with PAC providers on a frequent and regular basis to provide feedback
on implementation and resolve any perceived inconsistencies in the
proposed rule.
Response: We appreciate the commenter's feedback. It is our intent
to move forward with IMPACT Act implementation in a manner in which the
measure development process continues to be transparent, and includes
input and collaboration from experts, the PAC provider community, and
the public at large. It is of the utmost importance to CMS to continue
to engage stakeholders, including patients and their families,
throughout the measure development lifecycle through their
participation in our measure development public comment periods; the
pre-rulemaking process; participation in the TEPs provided by our
measure development contractors, as well as open door forums and other
opportunities. We have already provided multiple opportunities for
stakeholder input, which include the following activities: our measure
development contractor(s) convened a TEP that included stakeholder
experts on February 3, 2015; we convened two separate listening
sessions on February 10th and March 24, 2015; we heard stakeholder
input during the February 9th 2015 ad hoc MAP meeting provided for the
sole purpose of reviewing the measures adopted in response to the
IMPACT Act. Additionally, we implemented a public mail box for the
submission of comments in January 2015,
PACQualityInitiative@cms.hhs.gov, which is listed on our post-acute
care quality initiatives Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html,
and we held a Special Open Door Forum to seek input on the measures on
February 25, 2015. The slides from the Special Open Door Forum are
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html.
Comment: One commenter expressed concern at the brief time between
the passage of the IMPACT Act and the development of the proposed rule
because it did not allow for extensive coordination with the
professional community. While the commenter appreciated the opportunity
to participate in the IMPACT Act listening session, the commenter
viewed the proposed rule for the SNF QRP as hasty and reactive,
contrary to the deliberate and measured process that was recommended by
stakeholders and sought by CMS through the collaborative listening
session.
Response: We appreciate the public's interest in active
participation in the measure development process. As noted in the
proposed rule, the timeline and sequence of events proposed for the SNF
QRP, which is generally followed in other quality reporting programs,
requires that we give providers sufficient time after adoption of
measures and before reporting obligations begin to enable them to
prepare to report the data. We intend to propose measures consistent
with the sequence we follow in other quality reporting programs. As
noted above, we engaged in multiple activities to solicit stakeholder
input including TEPs, listening sessions, ad hoc MAP meetings, Special
Open Door Forums and a public email address. As described above, we
also initiated an Ad Hoc MAP process to obtain input on the measures
that we are finalizing in this final rule.
On February 5th, 2015, we made publicly available a list of
Measures Under Consideration (called the ``List of Ad Hoc Measures
Under Consideration for the Improving Medicare Post-Acute Care
Transformation (IMPACT) Act of 2014'') (MUC list) as part of an Ad Hoc
MAP convened by the NQF. The MAP Post-Acute Care/Long-Term Care
Workgroup convened on February 9, 2015 to ``review the measures
technical properties as they are adapted for use in new settings and
whether the new settings impact the measures' adherence to the NQF
Scientific Acceptability criterion.'' \18\ The NQF published the MUC
list on our behalf for public comment from February 11, 2015 through
February 19, 2015 on its Web site. The MAP Coordinating Committee
convened on February 27, 2015 to discuss the public comments received,
and those public comments are listed here https://public.qualityforum.org/MAP/MAP%20Coordinating%20Committee/MAP_CC%20Feb%2027_Discussion_Guide.html#agenda.
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\18\ . Ad-hoc Review: Expansion of Settings . (n.d.). Retrieved
March 5, 2015, from https://www.qualityforum.org/Projects/a-b/Ad_Hoc_Reviews/CMS/Ad_Hoc_Reviews-CMS.aspx.
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The MAP issued a pre-rulemaking report on March 6, 2015. This Pre-
Rulemaking Report is available for download at https://www.qualityforum.org/Project_Pages/MAP_Post-Acute_CareLong-Term_Care_Workgroup.aspx. The MAP's input for
[[Page 46431]]
each of the proposed measures is discussed in this section.
Section 1899B(j) of the Act requires that we allow for stakeholder
input as part of the pre-rulemaking process. Therefore, we sought
stakeholder input on the measures we proposed to adopt in this final
rule as follows: We implemented a public mail box for the submission of
comments in January 2015, PACQualityInitiative@cms.hhs.gov which is
located on our post-acute care quality initiatives Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html; we convened a TEP that included
stakeholder experts and patient representatives on February 3, 2015;
and we sought public input during the February 2015 ad hoc MAP process.
In addition, we held a National Stakeholder Special Open Door Forum on
February 25, 2015 for the purpose of seeking input on these measures.
Lastly, we held two separate listening sessions on February 10 and
March 24, 2015, respectively. These sessions sought feedback from
providers regarding best practices for collecting quality data with
respect to the IMPACT Act requirements.
Comment: Multiple commenters expressed concern that the MAP process
was not implemented properly and had concerns about when MAP Workgroup
rosters are open for public comment, the inclusion of additional
measures during the MAP, and other items such as MAP composition.
Commenters also expressed concern that the open door forums and
listening sessions designed to meet public input requirements did not
include sufficient public discussion of the proposed quality measures.
One commenter stated that there is confusion among NQF and MAP members
over whether they can review all related NQF-endorsed measures or are
restricted to reviewing only measures preferred by CMS and requested
that CMS issue them written guidance. In addition, the commenter urged
CMS to change the MAP public comment process.
Response: With regard to the commenters' concerns pertaining to the
processes associated with the MAP such as when MAP Workgroup rosters
are open for public comment, the inclusion of additional measures
during the MAP, and other items such as MAP composition, we note that
the operations of the MAP are directed by the NQF, and not by CMS.
Further, while the MAP provides input on measures selected by the
Secretary, the pre rulemaking provisions of the Act do not restrict the
MAP from reviewing or recommending alternative measures and
methodologies to those proposed by the Secretary. Therefore, we refer
readers to the MAP Web site at https://www.qualityforum.org/map/.
Additionally, we intend to provide the commenters' input to the NQF.
We also, as part of our measure development process for the
proposed measures, sought public input at the February 2015 Special
Open Door Forum, during which we provided information pertaining to the
IMPACT Act and the measures that were listed as Measures Under
Consideration for the IMPACT Act of 2014 for review by the MAP. We also
advised that interested parties could submit feedback and questions on
the measures and other topics, via our mailbox,
PACQualityInitiative@cms.hhs.gov. We also sought feedback from subject
matter experts who responded to an open call to participate in the
numerous TEPs held by our measure development contractor for all
measures considered for adoption into the SNF QRP prior to rulemaking.
c. Policy for Retaining SNF QRP Measures for Future Payment
Determinations
For the SNF QRP, for the purpose of streamlining the rulemaking
process, we proposed that when we adopt a measure for the SNF QRP for a
payment determination, this measure would be automatically retained in
the SNF QRP for all subsequent payment determinations unless we propose
to remove, suspend, or replace the measure.
Section 1899B(h)(1) of the Act provides that the Secretary may
remove, suspend or add a quality measure or resource use or other
measure specified under section 1899B(c)(1) or (d)(1) of the Act so
long as the Secretary publishes a justification for the action in the
Federal Register with a notice and comment period. Consistent with the
policies of other QRPs including the HIQR Program, the HOQR Program,
LTCH QRP, and the IRF QRP, we proposed that quality measures would be
considered for removal if: (1) Measure performance among SNFs is so
high and unvarying that meaningful distinctions in improvements in
performance can no longer be made in which case the measure may be
removed or suspended; (2) performance or improvement on a measure does
not result in better resident outcomes; (3) a measure does not align
with current clinical guidelines or practice; (4) a more broadly
applicable measure (across settings, populations, or conditions) for
the particular topic is available; (5) a measure that is more proximal
in time to desired resident outcomes for the particular topic is
available; (6) a measure that is more strongly associated with desired
resident outcomes for the particular topic is available; or (7)
collection or public reporting of a measure leads to negative
unintended consequences other than resident harm.
We also noted that under section 1899B(h)(2) of the Act, in the
case of a quality measure or resource use or other measure for which
there is a reason to believe that the continued collection raises
possible safety concerns or would cause other unintended consequences,
the Secretary may promptly suspend or remove the measure and publish
the justification for the suspension or removal in the Federal Register
during the next rulemaking cycle.
For any measure that meets this criterion (that is, a measure that
raises safety concerns), we will take immediate action to remove the
measure from SNF QRP, and, in addition to publishing a justification in
the next rulemaking cycle, will immediately notify SNFs and the public
through the usual communication channels, including listening session,
memos, email notification, and web postings.
We invited public comment on this proposed policy for Retaining SNF
QRP Measures for Future Payment Determinations. The following is a
summary of the comments received and our responses.
Comment: One commenter supported several of the criteria for
possible removal of a measure but opposed or recommended changes to
other criteria. The commenter recommended changes to deleting criteria
to remove measures that have high performance, remove or clarify
phrases associated with the term ``clinical practice,'' and also
incorporating language to clarify how to add measures rather than
remove them.
Response: We interpret the comment to mean that CMS should maintain
measures that have high performance. We required reporting on measures
with high performance rates in the past. We will continue to perform a
case-by-case analysis through program monitoring to evaluate the
importance of measure continuation vs. measure suppression or removal.
Additionally, we will evaluate the application of language and phrases
associated with the term clinical practice as necessary. We believe
that we have addressed the approach we take in measure selection and
proposal for adoption in our preamble, and when we present our measures
under consideration. Generally, we apply an
[[Page 46432]]
approach that involves alignment with the National Quality Strategy,
and the CMS Quality Strategy, with an effort to address gaps in quality
and priority areas for achieving high quality care. We note that the
proposed criteria for consideration for removal of measures in the SNF
QRP are consistent with the policies of other QRPs in the Medicare
Program, including the HIQR Program, the HOQR Program, LTCH QRP, and
the IRF QRP.
After consideration of the public comments received, we are
finalizing the adoption of the policy for retaining SNF QRP Measures
for Future Payment Determinations as proposed.
d. Process for Adoption of Changes to SNF QRP Program Measures
Section 1899B(e)(2) required that quality measures under the IMPACT
Act selected for the SNF QRP must be endorsed by the NQF unless they
meet the criteria for exception in section 1899B(e)(2)(B) of the Act.
The NQF is a voluntary consensus standard-setting organization with a
diverse representation of consumer, purchaser, provider, academic,
clinical, and other healthcare stakeholder organizations. The NQF was
established to standardize healthcare quality measurement and reporting
through its consensus development process (https://www.qualityforum.org/About_NQF/Mission_and_Vision.aspx). The NQF undertakes review of: (a)
New quality measures and national consensus standards for measuring and
publicly reporting on performance; (b) regular maintenance processes
for endorsed quality measures; (c) measures with time-limited
endorsement for consideration of full endorsement; and (d) ad hoc
review of endorsed quality measures, practices, consensus standards, or
events with adequate justification to substantiate the review (https://www.qualityforum.org/Measuring_Performance/Ad_Hoc_Reviews/Ad_Hoc_Review.aspx).
The NQF solicits information from measure stewards for annual
reviews and to review measures for continued endorsement in a specific
3-year cycle. In this measure maintenance process, the measure steward
is responsible for updating and maintaining the currency and relevance
of the measure and for confirming existing specifications to the NQF on
an annual basis. As part of the ad hoc review process, the ad hoc
review requester and the measure steward are responsible for submitting
evidence for review by a NQF TEP which, in turn, provides input to the
Consensus Standards Approval Committee which then makes a decision on
endorsement status and/or specification changes for the measure,
practice, or event.
The NQF regularly maintains its endorsed measures through annual
and triennial reviews, which may result in the NQF making updates to
the measures. We believe that it is important to have in place a
subregulatory process to incorporate nonsubstantive updates made by the
NQF into the measure specifications as we have adopted for the Hospital
IQR Program so that these measures remain up-to-date. We also recognize
that some changes the NQF might make to its endorsed measures are
substantive in nature and might not be appropriate for adoption using a
subregulatory process.
Therefore, in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53504
through 53505), we finalized a policy under which we use a
subregulatory process to make nonsubstantive updates to measures used
for the Hospital IQR Program. For what constitutes substantive versus
nonsubstantive changes, we expect to make this determination on a case-
by-case basis. Examples of nonsubstantive changes to measures might
include updated diagnosis or procedure codes, medication updates for
categories of medications, broadening of age ranges, and exclusions for
a measure (such as the addition of a hospice exclusion to the 30-day
mortality measures). We believe that nonsubstantive changes may include
updates to NQF-endorsed measures based upon changes to guidelines upon
which the measures are based.
Therefore, we proposed to use rulemaking to adopt substantive
updates made to measures as we have for the Hospital IQR Program.
Examples of changes that we might consider to be substantive would be
those in which the changes are so significant that the measure is no
longer the same measure, or when a standard of performance assessed by
a measure becomes more stringent (for example, changes in acceptable
timing of medication, procedure/process, or test administration).
Another example of a substantive change would be where the NQF has
extended its endorsement of a previously endorsed measure to a new
setting, such as extending a measure from the inpatient setting to
hospice. These policies regarding what is considered substantive versus
nonsubstantive would apply to all measures in the SNF QRP. We also note
that the NQF process incorporates an opportunity for public comment and
engagement in the measure maintenance process.
We believe this policy adequately balances our need to incorporate
updates to the SNF QRP measures in the most expeditious manner possible
while preserving the public's ability to comment on updates that so
fundamentally change an endorsed measure that it is no longer the same
measure that we originally adopted.
We invited public comment on our Proposed Process for the Adoption
of Changes to SNF QRP Program Measures. The following is a summary of
the comments received and our responses.
Comment: One commenter suggested that CMS more clearly define the
subregulatory process criteria for determining what constitutes a non-
substantive change and recommended that CMS not wait until rulemaking
to make changes that are considered substantive and have progressed
through the NQF process.
Response: We believe that it is important to have in place a
subregulatory process to incorporate nonsubstantive updates made by the
NQF into the measure specifications so that the measures remain up-to-
date. For example, we could use the CMS Web site as a place to announce
changes. As noted in the proposed rule, the subregulatory process
proposed is the same process as we have adopted for the Hospital IQR
Program and which has been used successfully in that program. We
believe that the criteria for what constitutes a non-substantive change
could vary widely and is best described by examples, as we have done in
the proposed rule. As noted, what constitutes a substantive versus
nonsubstantive changes is determined on a case-by-case basis.
Final Decision: After consideration of the public comments, we are
finalizing the adoption of the Process for Adoption of Changes to SNF
QRP Program Measures.
New Quality Measures for FY 2018 and Subsequent Payment Determinations
For the FY 2018 SNF QRP and subsequent years, we proposed to adopt
three cross-setting quality measures to meet the requirements of the
IMPACT Act. These measures address the following domains: (1) Skin
integrity and changes in skin integrity; (2) incidence of major falls;
and (3) functional status, cognitive function, and changes in function
and cognitive function, which are all required measure domains under
section 1899B(c)(1) of the Act. The proposed quality measure addressing
skin integrity and changes in skin integrity is the NQF-endorsed
measure, Percent of Residents or Patients with Pressure
[[Page 46433]]
Ulcers That Are New or Worsened (Short Stay) (NQF #0678) (https://www.qualityforum.org/QPS/0678). The proposed quality measure addressing
the incidence of major falls is an application of the NQF-endorsed
Percent of Residents Experiencing One or More Falls with Major Injury
(Long Stay) (NQF #0674) (https://www.qualityforum.org/QPS/0674).
Finally, the proposed quality measure addressing functional status,
cognitive function, and changes in function and cognitive function is
an application of the Percent of Long-Term Care Hospital Patients With
an Admission and Discharge Functional Assessment and a Care Plan that
Addresses Function (NQF #2631; endorsed on July 23, 2015) (https://www.qualityforum.org/QPS/2631).
The proposed quality measures addressing the domains of incidence
of major falls and functional status, cognitive function, and changes
in function and cognitive function, are not currently NQF-endorsed for
the SNF population. We reviewed the NQF's endorsed measures and were
unable to identify any NQF-endorsed cross-setting quality measures that
focused on these domains. We are also unaware of any other cross-
setting quality measures that have been endorsed or adopted by another
consensus organization.
Section 1899B(e)(2) of the Act requires we use a NQF-endorsed
measure unless the measure meets the exception. In the case of a
specified area or medical topic determined by the Secretary for which a
feasible and practical measure has not been NQF endorsed, the Secretary
may specify a measure that is not so endorsed as long as due
consideration is given to a measure that has been endorsed or adopted
by a consensus organization identified by the Secretary.
We received several general comments pertaining to the topic of our
use of measures that are not endorsed or are not endorsed for use in
the SNF resident population, as well as processes related to our
adoption of such measures, their reliability and processes pertaining
to the NQF endorsement process as well as the MAP review process. The
following is a summary of the comments received and our responses.
Comment: We received several comments about the reliability and
accuracy of the proposed measures. We also received several comments
supporting and encouraging the use of NQF endorsed measures and
commenters expressed concerns that not all of the measures proposed for
the FY 2018 payment determination were NQF endorsed. One commenter
expressed concern that the statute's exemption allowing the use of
measures that are not NQF endorsed provided that ``due consideration''
is given to endorsed measures is not well defined. One commenter urged
CMS to use only measures that have been NQF endorsed as cross-setting
measures and another commenter expressed that all measures should be
reviewed by the MAP and a technical expert panel (TEP). Additionally,
one commenter believed that all measures should be NQF endorsed before
they are specified and if the measure is not endorsed, CMS should
specify the criteria justifying the exception to endorsement. In
addition, one commenter suggested that the NQF endorsement process does
not take into account the expertise necessary for rehabilitation
services and post-acute care services.
Response: We intend to consider and propose appropriate measures
that meet the requirements of the IMPACT Act measure domains and that
have been endorsed or adopted by a consensus organization, whenever
possible. However, when this is not feasible because there is no NQF-
endorsed measure that meets all the requirements for a specified IMPACT
Act measure domain, we intend to rely on the exception authority given
to the Secretary in section 1899B(e)(2)(B) of the Act. This statutory
exception, allows the Secretary to specify a measure for the SNF QRP
setting that is not NQF-endorsed where, as here, we have not been able
to identify other measures on the topic that are endorsed or adopted by
a consensus organization. With respect to the proposed measures for the
SNF QRP, we sought MAP review, as well as expert opinion, on the
validity and reliability of those measures. We disagree with the
commenter who expressed concerns pertaining to the expertise applied in
the panels overseeing the NQF endorsement proceedings; however, we
intend to provide this feedback to the NQF.
(1) Quality Measure Addressing the Domain of Skin Integrity and Changes
in Skin Integrity: Percent of Residents or Patients With Pressure
Ulcers That Are New or Worsened (Short Stay) (NQF #0678)
We proposed to adopt for the SNF QRP, beginning with the FY 2018
payment determination, the Percent of Residents or Patients with
Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678)
measure as a cross-setting quality measure that satisfies the skin
integrity and changes in skin integrity domain. This measure assesses
the percentage of short-stay residents or patients in SNFs, IRFs, and
LTCHs with Stage 2 through 4 pressure ulcers that are new or worsened
since admission.
Pressure ulcers are a serious medical condition that result in
pain, decreased quality of life, and increased mortality in aging
populations.19 20 21 22 Pressure ulcers typically are the
result of prolonged periods of uninterrupted pressure on the skin, soft
tissue, muscle, and bone.23 24 25 Older adults in SNFs are
prone to a wide range of medical conditions that increase their risk of
developing pressure ulcers. These medical conditions include impaired
mobility or sensation, malnutrition or under-nutrition, obesity,
stroke, diabetes, dementia, cognitive impairments, circulatory
diseases, dehydration, the use of wheelchairs, medical devices, and a
history of pressure ulcers or a pressure ulcer at
admission.26 27 28 29 30 31 32 33 34 35 36
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\19\ Casey, G. (2013). ``Pressure ulcers reflect quality of
nursing care.'' Nurs N Z 19(10): 20-24.
\20\ Gorzoni, M. L. and S. L. Pires (2011). ``Deaths in nursing
homes.'' Rev Assoc Med Bras 57(3): 327-331.
\21\ Thomas, J. M., et al. (2013). ``Systematic review: health-
related characteristics of elderly hospitalized adults and nursing
home residents associated with short-term mortality.'' J Am Geriatr
Soc 61(6): 902-911.
\22\ White-Chu, E. F., et al. (2011). ``Pressure ulcers in long-
term care.'' Clin Geriatr Med 27(2): 241-258.
\23\ Bates-Jensen BM. Quality indicators for prevention and
management of pressure ulcers in vulnerable elders. Ann Int Med.
2001;135 (8 Part 2), 744-51.
\24\ Institute for Healthcare Improvement (IHI). Relieve the
pressure and reduce harm. May 21, 2007. Available from https://www.ihi.org/IHI/Topics/PatientSafety/SafetyGeneral/ImprovementStories/FSRelievethePressureandReduceHarm.htm
\25\ Russo CA, Steiner C, Spector W. Hospitalizations related to
pressure ulcers among adults 18 years and older, 2006 (Healthcare
Cost and Utilization Project Statistical Brief No. 64). December
2008. Available from https://www.hcupus.ahrq.gov/reports/statbriefs/sb64.pdf.
\26\ Agency for Healthcare Research and Quality (AHRQ). Agency
news and notes: pressure ulcers are increasing among hospital
patients. January 2009. Available from https://www.ahrq.gov/research/jan09/0109RA22.htm.=
\27\ Bates-Jensen BM. Quality indicators for prevention and
management of pressure ulcers in vulnerable elders. Ann Int Med.
2001;135 (8 Part 2), 744-51.
\28\ Cai, S., et al. (2013). ``Obesity and pressure ulcers among
nursing home residents.'' Med Care 51(6): 478-486.
\29\ Casey, G. (2013). ``Pressure ulcers reflect quality of
nursing care.'' Nurs N Z 19(10): 20-24.
\30\ Hurd D, Moore T, Radley D, Williams C. Pressure ulcer
prevalence and incidence across post-acute care settings. Home
Health Quality Measures & Data Analysis Project, Report of Findings,
prepared for CMS/OCSQ, Baltimore, MD, under Contract No. 500-2005-
000181 TO 0002. 2010.
\31\ MacLean DS. Preventing & managing pressure sores. Caring
for the Ages. March 2003;4(3):34-7. Available from https://www.amda.com/publications/caring/march2003/policies.cfm.
\32\ Michel, J. M., et al. (2012). ``As of 2012, what are the
key predictive risk factors for pressure ulcers? Developing French
guidelines for clinical practice.'' Ann Phys Rehabil Med 55(7): 454-
465.
\33\ National Pressure Ulcer Advisory Panel (NPUAP) Board of
Directors; Cuddigan J, Berlowitz DR, Ayello EA (Eds). Pressure
ulcers in America: prevalence, incidence, and implications for the
future. An executive summary of the National Pressure Ulcer Advisory
Panel Monograph. Adv Skin Wound Care. 2001;14(4):208-15.
\34\ Park-Lee E, Caffrey C. Pressure ulcers among nursing home
residents: United States, 2004 (NCHS Data Brief No. 14).
Hyattsville, MD: National Center for Health Statistics, 2009.
Available from https://www.cdc.gov/nchs/data/databriefs/db14.htm.
\35\ Reddy, M. (2011). ``Pressure ulcers.'' Clin Evid (Online)
2011.
\36\ Teno, J. M., et al. (2012). ``Feeding tubes and the
prevention or healing of pressure ulcers.'' Arch Intern Med 172(9):
697-701.
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[[Page 46434]]
Section 1899B(a)(1)(B) of the IMPACT Act requires that the data
submitted on quality measures under section 1899B(c)(1) of the Act be
standardized and interoperable across PAC settings, and section
1899B(c)(2)(A) of the Act requires that the measures be reported
through the use of a PAC assessment instrument. These requirements are
in line with the NQF Steering Committee report, which stated that ``to
understand the impact of pressure ulcers across settings, quality
measures addressing prevention, incidence, and prevalence of pressure
ulcers must be harmonized and aligned.'' \37\ This measure has been
implemented in nursing homes for resident population with stays of less
than 100 days under CMS's Nursing Home Quality Initiative. We also
adopted the measure for use in the LTCH QRP (76 FR 51753 through 51756)
beginning with the FY 2014 payment determination, and for use in the
IRF QRP (76 FR 47876 through 47878) beginning with the FY 2014 payment
determination. We have not, to date, adopted the measure for the home
health setting. More information on the NQF endorsed quality measure
the Percent of Residents or Patients with Pressure Ulcers That Are New
or Worsened (Short Stay) (NQF #0678), is available at https://www.qualityforum.org/QPS/0678.
---------------------------------------------------------------------------
\37\ National Quality Forum. National voluntary consensus
standards for developing a framework for measuring quality for
prevention and management of pressure ulcers. April 2008. Available
from https://www.qualityforum.org/Projects/Pressure_Ulcers.aspx
---------------------------------------------------------------------------
A TEP convened by our measure development contractor provided input
on the technical specifications of the quality measure, the Percent of
Residents or Patients with Pressure Ulcers That Are New or Worsened
(Short Stay) (NQF #0678), including the feasibility of implementing the
measure across PAC settings. The TEP supported the measure's
implementation across PAC settings and was also supportive of our
efforts to standardize the measure for cross-setting development. The
MAP also supported the use of the quality measure the Percent of
Residents or Patients with Pressure Ulcers that are New or Worsened
(Short Stay) (NQF #0678) in the SNF QRP as a cross-setting quality
measure.
We proposed that the data for this quality measure would be
collected using the MDS 3.0, currently submitted by SNFs through the
Quality Improvement and Evaluation System (QIES) Assessment Submission
and Processing (ASAP) system. We believe that this data collection
method will minimize the reporting burden on SNFs because SNFs are
already required to submit MDS data for multiple purposes, such as for
payment purposes. For more information on SNF submission using the QIES
ASAP system, readers are referred to https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIMDS30TechnicalInformation.html.
The data items that we proposed to calculate the quality measure,
the Percent of Residents or Patients with Pressure Ulcers that are New
or Worsened (Short Stay) (NQF #0678) include: M0800A (Worsening in
Pressure Ulcer Status Since Prior Assessment (OBRA or scheduled PPS
assessment) or Last Admission/Entry or Reentry, Stage 2), M0800B
(Worsening in Pressure Ulcer Status Since Prior Assessment (OBRA or
scheduled PPS assessment) or Last Admission/Entry or Reentry, Stage 3),
and M0800C (Worsening in Pressure Ulcer Status Since Prior Assessment
(OBRA or scheduled PPS assessment) or Last Admission/Entry or Reentry,
Stage 4). This measure would be calculated at two points in time, at
admission and discharge (see Form, Manner, and Timing of Quality Data
Submission). The specifications and data items for the quality measure,
the Percent of Residents or Patients with Pressure Ulcers that are New
or Worsened (Short Stay) (NQF #0678) are available in the MDS 3.0
Quality Measures User's Manual available on our Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIQualityMeasures.html.
We invited public comments on our proposal to adopt the Percent of
Residents or Patients with Pressure Ulcers that are New or Worsened
(Short Stay) (NQF #0678) for the SNF QRP for the FY 2018 payment
determination and subsequent years. The following is a summary of the
comments received and our responses.
Comment: We received many comments in support of our proposal to
implement the Percent of Residents or Patients with Pressure Ulcers
that are New or Worsened quality measure (Short Stay) (NQF #0678) to
fulfill the requirements of the IMPACT Act. Commenters believed that
measuring skin integrity and changes in skin integrity is important in
the post-acute care setting and appreciated that the pressure ulcer
measure is NQF-endorsed and is already collected for the Nursing Home
Quality Initiative using the MDS 3.0 data.
Response: We thank the commenters for their support of the Percent
of Residents or Patients with Pressure Ulcers that are New or Worsened
(Short Stay) (NQF #0678) to fulfill the requirements of the IMPACT Act.
We agree that skin integrity and changes in skin integrity are high
priority issues for PAC settings.
Comment: One commenter supported our proposal to use the MDS 3.0 as
the source of data collection for this measure and to have SNFs submit
the data via the QIES ASAP system.
Response: We thank the commenter for its support of the use of the
MDS 3.0 and the QIES ASAP system for data collection and reporting of
the pressure ulcer measure. The ongoing use of the MDS 3.0 and the QIES
ASAP system will minimize burden for SNFs.
Comment: Several commenters were supportive of the intent of this
measure but provided recommendations regarding risk adjustment of the
pressure ulcer measure. Commenters highlighted the importance of risk
adjusting all quality measures and expressed concern that the measure
may not be risk adjusted appropriately for the diverse populations
across PAC settings. The commenters encouraged CMS to engage in ongoing
evaluation of the risk adjustment methodology used for this measure to
ensure that the methodology is appropriate for standard cross-setting
risk adjustment, as the current risk adjustment methodology is based on
data collection tools specific to each PAC setting. Commenters
recommended that CMS add several different risk factors to the risk
adjustment model including: primary diagnosis; impairments;
demographics; co-existing conditions/comorbidities; decreased sensory
awareness; and patients or residents at the end of life. Commenters
also encouraged CMS to ensure that the measure is fully tested prior to
implementation in the QRPs.
One commenter was concerned that the measure is limited to only
high risk
[[Page 46435]]
patients or residents, and that the denominator size is decreased by
excluding individuals who are low risk. The commenter indicated that
pressure ulcers do develop in low risk individuals and that this
exclusion will impact each PAC setting differently because the
prevalence of low risk individuals varies across settings. The
commenter recommended that CMS use a logistic regression model for risk
adjustment to allow for an increase in the measure sample size by
including all admissions, take into consideration low volume providers,
and capture the development of pressure ulcers in low risk individuals.
The commenter suggested that a patient or resident's risk is not
dichotomous (for example, high risk vs. low risk) and recommended that
CMS grade risk using an ordinal scale related to an increasing number
and severity of risk factors. The commenter also expressed that the
populations and types of risk for pressure ulcers varies significantly
across PAC settings, and that using a logistic regression model would
be a more robust way to include a wide range of risk factors to better
reflect the population across PAC settings. The commenter noted that
the TEP that evaluated this cross-setting pressure ulcer measure also
recommended that CMS consider expanding the risk adjustment model and
discussed excluding or risk adjusting for hospice patients and those at
the end of life.
Response: We thank the commenters for their support of the intent
of this measure and for their recommendations regarding risk adjustment
for this measure. Section 1899B(c)(3)(B) of the Act states that quality
measures shall be risk adjusted, as determined appropriate by the
Secretary. In regards to the commenter who recommended we risk adjust
using a logistic regression model and incorporate low risk patients
into the measure, we believe that this commenter may have submitted
comments regarding the wrong quality measure. Their comments apply to
the quality measure Percent of High Risk Residents with Pressure Ulcers
(Long Stay) (NQF #0679), which is not the measure that we proposed for
the SNF QRP. The proposed measure is the Percent of Residents or
Patients with Pressure Ulcers that are New or Worsened (NQF #0678).
This measure is currently risk adjusted using a logistic regression
model and includes low risk residents. In the model, patients or
residents are categorized as either high or low risk based on four risk
factors: (1) Functional limitation; (2) bowel incontinence; (3)
diabetes or peripheral vascular disease/peripheral arterial disease;
and (4) low body mass index (BMI). An expected score is calculated for
each patient or resident using that patient or resident's risk level on
the four risk factors described above. The patient/resident-level
expected scores are then averaged to calculate the facility-level
expected score, which is compared to the facility-level observed score
to calculate the adjusted score for each facility. Additional detail
regarding risk adjustment for this measure is available in the measure
specifications, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html.
When developing the risk adjustment model for this measure, we
reviewed the literature, conducted analyses to test additional risk
factors, convened TEPs to seek stakeholder input, and obtained clinical
guidance from subject matter experts and other stakeholders to identify
additional risk factors. We have determined that risk adjustment is
appropriate for this measure. Therefore, we have developed and
implemented the risk adjustment model using the risk factors described
above. Nonetheless, we will continue to analyze this measure as more
data is collected and will consider changing the risk adjustment model,
expanding the risk stratifications, and testing the inclusion of other
risk factors as additional risk adjustors for future iterations of the
measure. We will also take into consideration the TEP discussion and
the commenter's feedback regarding the exclusion or risk adjustment for
hospice patients and those at the end of life. As we transition to
standardized data collection across PAC settings to meet the mandate of
the IMPACT Act, we intend to continue our ongoing measure development
and refinement activities to inform the ongoing evaluation of risk
adjustment models and methodology. This continued refinement of the
risk adjustment models will ensure that the measure remains valid and
reliable to inform quality improvement within and across each PAC
setting, and to fulfill the public reporting goals of QRPs, including
the SNF QRP.
Comment: One commenter requested that CMS consider risk adjusting
the quality measure for sociodemographic status, to better reflect the
realities that affect the care of special populations and the need for
coordination with hospitals within a geographic region. The commenter
suggested that some beneficiaries in certain populations are more
complex, and therefore, their skin integrity may be compromised.
Response: While we appreciate these comments and the importance of
the role that sociodemographic status plays in the care of patients, we
continue to have concerns about holding providers to different
standards for the outcomes of their patients of low sociodemographic
status because we do not want to mask potential disparities or minimize
incentives to improve the outcomes of disadvantaged populations. We
routinely monitor the impact of sociodemographic status on facilities'
results on our measures.
NQF is currently undertaking a 2-year trial period in which new
measures and measures undergoing maintenance review will be assessed to
determine if risk-adjusting for sociodemographic factors is appropriate
for each measure. For 2 years, NQF will conduct a trial of a temporary
policy change that will allow inclusion of sociodemographic factors in
the risk-adjustment approach for some performance measures. At the
conclusion of the trial, NQF will determine whether to make this policy
change permanent. Measure developers must submit information such as
analyses and interpretations as well as performance scores with and
without sociodemographic factors in the risk adjustment model.
Furthermore, the Office of the Assistant Secretary for Planning and
Evaluation (ASPE) is conducting research to examine the impact of
socioeconomic status on quality measures, resource use, and other
measures under the Medicare program as directed by the IMPACT Act. We
will closely examine the findings of these reports and related
Secretarial recommendations and consider how they apply to our quality
programs at such time as they are available.
Comment: One commenter expressed concerns that although the MAP
supports the cross-setting use of this measure, it is only NQF endorsed
for the SNF setting and suggested that CMS delay implementing the
cross-setting measure until it is NQF endorsed across all PAC settings.
The commenter also pointed out that the specifications available on the
NQF Web site are dated October 2013.
Response: Although the proposed pressure ulcer measure was
originally developed for the SNF/nursing home resident population, it
has been re-specified for the LTCH and IRF settings, underwent review
for expansion to the LTCH and IRF settings by the NQF Consensus
Standards Approval
[[Page 46436]]
Committee (CSAC) on July 11, 2012 \38\ and was subsequently ratified by
the NQF Board of Directors for expansion to the LTCH and IRF settings
on August 1, 2012.\39\ As reflected on the NQF Web site the endorsed
settings for this measure include Post-Acute/Long Term Care Facility:
Inpatient Rehabilitation Facility, Post Acute/Long Term Care Facility:
Long Term Acute Care Hospital, Post Acute/Long Term Care Facility:
Nursing Home/Skilled Nursing Facility.\40\ NQF endorsement of this
measure indicates that NQF supports the use of this measure in the LTCH
and IRF settings, as well as in the SNF setting. As one commenter
indicated, this measure was fully supported by the MAP for cross-
setting use at its meeting of February 9, 2015. With regard to the
measure specifications posted on the NQF Web site, the most up-to-date
version of the measure specifications were posted for stakeholder
review at the time of the proposed rule on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/Skilled-Nursing-Facility-Quality-Reporting-Program-Quality-Measure-Specifications-for-FY-2016-Notice-of-Proposed-Rule-Making-report.pdf. The specifications currently
posted on the NQF Web site are computationally equivalent and have the
same measure components as those posted on the CMS Web site at the time
of the proposed rule. However, we provided more detail in the
specifications posted with the proposed rule, in an effort to more
clearly explain aspects of the measure that were not as clear in the
NQF specifications. Additionally, we clarified language to make
phrasing more parallel across settings, and updated item numbers and
labels to match the 2016 data sets (MDS 3.0, LTCH CARE Data Sets, and
IRF-PAI). We are working closely with NQF to make updates and ensure
that the most current language and clearest version of the
specifications are available on the NQF Web site.
---------------------------------------------------------------------------
\38\ Nation Quality Forum, Consensus Standardbreds Approval
Committee. Meeting Minutes, July 11, 2012. 479-489.
\39\ National Quality Forum. NQF Removes Time-Limited
Endorsement for 13 Measures; Measures Now Have Endorsed Status.
August 1, 2012. Available; https://www.qualityforum.org/News_And_Resources/Press_Releases/2012/NQF_Removes_Time-Limited_Endorsement_for_13_Measures;_Measures_Now_Have_Endorsed_Statu
s.aspx.
\40\ National Quality Forum. Percent of Residents or Patients
with Pressure Ulcers that are New or Worsened (Short-Stay).
Available: https://www.qualityforum.org/QPS/0678.
---------------------------------------------------------------------------
Comment: A few commenters expressed concern regarding the
reliability and validity of this measure across different PAC settings.
The commenters were concerned that the reliability and validity testing
for this measure was only conducted in the SNF setting.
Response: Although this measure was originally developed for the
SNF setting, the NQF expanded its endorsement of the measure to the IRF
and LTCH settings as a cross setting quality measure in 2012, and the
expanded measure was finalized in the FY 2014 IRF PPS final rule (78 FR
47911 through 47912) and the FY 2014 IPPS/LTCH PPS final rule (78 FR
50861 through 50863). As part of quality measure maintenance for this
quality measure, we and our measure contractor will continue to perform
reliability and validity testing. Early data analyses have shown that
data continues to be valid and reliable.
We appreciate the commenters' concern that the SNF, LTCH, and IRF
populations are not identical and that some differences may exist in
the reliability and validity of the measure across settings. We are
working towards standardizing data across PAC settings as mandated in
the IMPACT Act. As such, we continue to conduct measure development and
testing to explore the best way to standardize quality measures, while
ensuring reliability and validity for the measures to appropriately
account for the unique differences in populations across PAC settings.
Comment: Several commenters were concerned that the pressure ulcer
measure is not standardized across PAC settings. The commenters stated
that although the measure appears meets the goals and the intent of the
IMPACT Act, it does not use a single data assessment tool.
One commenter specifically mentioned the frequency of assessments,
highlighting the fact that the LTCH and IRF versions of the measure are
calculated using two assessment time-points (admission and discharge),
while the SNF version uses multiple assessment time-points. The
commenter expressed concern that the higher frequency of assessments
for the MDS could potentially result in higher rates of pressure ulcer
counts for SNFs. Another commenter voiced particular concerns regarding
differences in the look-back periods, for the items used on the IRF,
SNF, and LTCH assessments (MDS=7-day assessment period, IRF=3-day
assessment period, LTCH = 3-day assessment period) and suggested that
this would result in different rates of detection of new or worsened
ulcers. Commenters encouraged CMS to address all of these
discrepancies, and suggested that we should switch to using only an
admission and discharge assessment in the SNF version of the measure.
Response: We appreciate the commenters' review of the measure
specifications across the post-acute care settings. We wish to clarify
that while the IMPACT Act requires the modification of PAC assessment
instruments to revise or replace certain existing patient assessment
data with standardized patient assessment data as soon as practicable,
it does not require a single data collection tool. We intend to modify
the existing PAC assessment instruments as soon as practicable to
ensure the collection of standardized data. While we agree that it is
possible that within the PAC assessment instruments certain sections
could incorporate a standardized assessment data collection tool, for
example, the Brief Interview for Mental Status (BIMS), we have not yet
concluded that this kind of modification of the PAC assessment
instruments is necessary.
As to the concern that the pressure ulcer measure calculation is
based on more frequent assessments in the SNF setting than in the LTCH
and IRF settings, we wish to clarify that result of the measure
calculation for all three PAC providers is the same. For all three PAC
providers, the measure calculation ultimately shows the difference
between the number of pressure ulcers present on admission and the
number of new or worsened pressure ulcers present on discharge. While
SNF measure calculation arrives at that number differently than does
the measure calculation in the IRF and LTCH settings, ultimately all
three settings report the same result--as noted, the difference between
the number of pressure ulcers present on admission and the new or
worsened pressure ulcers at discharge. To explain, in IRFs and LTCHs,
pressure ulcer assessment data is obtained only at two points in time--
on admission and on discharge. Therefore, the calculation of the
measure includes all new or worsened pressure ulcers since admission.
In contrast, in SNFs pressure ulcer assessment data is obtained on
admission, at intervals during the stay (referred to as ``interim
assessments''), and at discharge. Each interim assessment and the
discharge assessment only look back to whether there were new or
worsened pressure ulcers since the last interim assessment. The sum of
number of new or worsened pressure ulcers identified at each interim
assessment and at the time of discharge yields the total number of new
or worsened pressure ulcers that
[[Page 46437]]
occurred during the stay and that were present on discharge. In other
words, the collection of pressure ulcer data in LTCHs and IRFs is
cumulative, whereas in SNFs, data collection is sequential. In both
cases the calculation reaches the same result--the total number of new
or worsened pressured ulcers between admission and discharge. Thus,
this is the same result of the measure calculation for SNFs as is
obtained for IRFs and LTCHs. With respect to the commenter's concern
that the use of interim assessment periods on the MDS will result in a
higher frequency of pressure ulcers for SNF residents, we clarify that
pressure ulcers found during interim assessments that heal before
discharge are not included in the measure calculation.
In regards to the commenter's concern about different look-back
periods, we acknowledge that although the LTCH CARE Data Set and IRF-
PAI allow up to the third day starting on the day of admission as the
assessment period and the MDS allows for an assessment period of
admission up to day 7, we note that the training manuals for SNFs,
LTCHs and IRFs provide specific and equivalent-coding instructions
related to the items used to calculate this measure (found in Section
M--skin conditions for all three assessments). These instructions
ensure that the assessment of skin integrity occurs at the initiation
of patients' or residents' PAC stays regardless of setting. All three
manuals direct providers to complete the skin assessment for pressure
ulcers present on admission as close to admission as possible, ensuring
a harmonized approach to the timing of the initial skin assessment.
Regardless of differences in the allowed assessment periods, providers
across PAC settings should adhere to best clinical practices,
established standards of care, and the instructions in their respective
training manuals, to ensure that skin integrity information is
collected as close to admission as possible. Although the manual
instructions are harmonized to ensure assessment at the beginning of
the stay, based on the commenter's feedback, we will take into
consideration the incorporation of uniform assessment periods for this
section of the assessments.
Comment: Commenters expressed concerns about the pressure ulcer
measure not being standardized across PAC settings, specifically noting
differences in the payers that are required to report patient or
resident data for this measure resulting in differences in the
denominators for each setting. Commenters also expressed concern with
the exclusion of Medicare Advantage beneficiaries from the numerator
and denominator for this measure. One commenter noted that measures
based on only Medicare FFS beneficiaries may be incomplete, because
according to some estimates, only about half of SNF residents are
covered by Medicare FFS.
In a related comment, a commenter expressed concern regarding
differences in the populations across quality measures in the SNF QRP.
The commenters stated that the falls measure (NQF #0674) and function
measure (NQF #2631) include only Medicare FFS residents, while the
pressure ulcer measure (NQF #0678) includes all short-stay NH
residents. The commenter mentioned that this inconsistency could result
in confusion for providers because of the varying denominators across
measures.
Response: We appreciate the commenters' comments pertaining to the
differences in the pressure ulcer quality measure denominators by payer
type across the IRF, SNF and LTCH settings. Additionally, we appreciate
the commenters' suggested expansion of the population used to calculate
all measures to include payer sources beyond Medicare PPS Part A and
agree that quality measures that include all persons treated in a
facility are better able to capture the health outcomes of that
facility's patients or residents, and that quality reporting on all
patients or residents is a worthy goal. Although we currently collect
data only on the SNF and the IRF Medicare populations, we believe that
quality care is best assessed through the collection of patient data
regardless of payer source and we agree that consistency in the data
would reduce confusion in data interpretation and enable a more
comprehensive evaluation of quality. We appreciate the commenter's
concerns and although we had not proposed all payer data collection
through this current rulemaking, we will take into consideration the
expansion of the SNF QRP to include all payer sources through future
rulemaking.
Comment: One commenter asked CMS to clarify how the addition of the
proposed SNF PPS Part A Discharge Assessment will impact the measure
specifications for the numerator and denominator of the pressure ulcer
measure. The commenter noted that CMS proposed modifying the MDS
discharge assessment to collect information for Part A FFS Medicare
beneficiaries who continue in the SNF after ending their Part A stay,
but did not clarify how this change will be implemented in the proposed
pressure ulcer measure. The commenter is concerned that if the new MDS
discharge assessment is not modified to add the pressure ulcer measure
assessment items, the measure will exclude individuals who are admitted
but not discharged from the SNF during their PAC stay, which will limit
CMS's ability to provide meaningful information to provider and
consumers. Finally the commenter expressed concern regarding the
increase in burden that will be required to complete this assessment,
and encouraged CMS to only include the minimum information necessary to
calculate the quality measures.
Response: We proposed that the SNF PPS Part A Discharge Assessment
would include the pressure ulcer data elements for the quality measure,
the Percent of Residents or Patients with Pressure Ulcers that are New
or Worsened (Short stay) (NQF #0678), in order to capture complete
pressure ulcer information for Medicare beneficiaries who continue in
the SNF after the end of a Part A stay (-all information between
admission and discharge or end of a Part A stay). For more information
on the Part A PPS Discharge assessment, we direct readers to the
specifications posted on the SNF QRP Measures and Technical Information
Web site, at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html.
Comment: Many commenters expressed concern with the accuracy of
data used to calculate the pressure ulcer measure. One commenter was
specifically concerned that CMS excludes residents or patients for whom
missing data precludes calculation of the measure from the measure
calculations. The commenter expressed that this exclusion may lead to
miscoding because if a facility recognizes that a resident is
declining, it can simply omit some data for that resident, ensuring
that the resident is excluded from the measure. The commenter
referenced several different media reports that highlight the
seriousness of gaming of MDS 3.0 data. One commenter noted a recent
survey that identified deficiencies in reporting by a small sample of
SNFs.
Response: As discussed below, we are finalizing our proposal that
beginning with the FY 2018 payment determination, any SNF that does not
meet the requirement that 80 percent of all MDS assessments submitted
contain 100 percent of all data items necessary to calculate the SNF
QRP measures would be subject to a reduction of 2
[[Page 46438]]
percentage points to its FY 2018 market basket percentage. This
requirement will provide an incentive to SNFs to submit complete MDS
3.0 assessments. Analysis of 2014 MDS 3.0 data submitted for the NHQI
indicates that for each of the three items used to calculate the
pressure ulcer measure (M0800A, M0800B, and M0800C), missing data for
calculating measures were approximately 0.1 percent across all target
assessments in a given quarter. Less than 0.1 percent of residents were
excluded due to missing all three items needed to calculate the
measure, suggesting that missing data is not a serious concern.
Further, we intend to align with other QRPs and propose through future
rulemaking a data validation process that will further ensure that data
reported for the SNF QRP is accurate and complete.
Comment: One commenter asked CMS to clarify whether the pressure
ulcer measure proposed for the SNF QRP can be reported using the
current MDS 3.0 pressure ulcer items, or if new items would be required
for this measure. The commenter asked if SNFs would be required to
submit different data for the SNF QRP and the Nursing Home Quality
Initiative.
Response: The proposed pressure ulcer measure is the same measure
that nursing homes have been reporting for short stay residents through
CMS's Nursing Home Quality Initiative since 2010. The items used to
calculate the measure are the same in the SNF QRP and the Nursing Home
Quality Initiative. SNFs will only be required to submit data for this
measure once to fulfill the requirements of both programs.
Comment: One commenter was concerned that the MDS 3.0 data does not
adequately capture multiple pressure ulcers and presence at admission
for each wound. The commenter was concerned that this could result in
confusion for SNFs as they may lose track of which ulcers were present
on admission and which are new or worsened, resulting in inaccurate
counts in the quality measure.
Response: The MDS 3.0 does not require SNF providers to provide
individual tracking information for each pressure ulcer. However, we
note that the MDS does not replace standard clinical practice. We
expect that all SNFs are conducting comprehensive skin assessments
throughout the stay and documenting all of the necessary information to
fully prevent and manage pressure ulcers for all residents. As such
SNFs are able to utilize the data they collect as part of standard
clinical practice to track and manage pressure ulcers, in order to
complete the MDS 3.0 items related to the improvement and worsening of
pressure ulcers during the resident's Part A covered stay in the
facility.
Comment: One commenter did not support the proposed measure, the
Percent of Residents or Patients with Pressure Ulcers that are New or
Worsened (Short Stay) (NQF #0678). The commenter was concerned that the
measure timeframe is too short to properly capture pressure ulcer
improvement, disadvantaging facilities that serve more frail
populations. The commenter indicated that capturing a healed pressure
ulcer is particularly difficult as SNFs have a very limited amount of
time from admission to the end of a short-stay episode to heal a
pressure ulcer.
Response: We would like to clarify that the proposed quality
measure assesses the percent of residents or patients with Stage 2-4
pressure ulcers that are new or worsened since the prior assessment,
and does not focus on capturing the improvement of pressure ulcers.
This measure specifies that if a pressure ulcer is present on admission
and worsened during the stay, it would be included in the numerator.
Further, if the pressure ulcer is present on admission, and did not
worsen during the stay, it would not be included in the numerator. We
agree with the commenter that the timeframe is often too short to heal
pressure ulcers amongst the frail and elderly population; therefore the
measure does not capture information about healed pressure ulcers.
Rather, the intent of the measure is to hold providers accountable for
preventing the worsening of or onset of new pressure ulcers.
Comment: One commenter expressed concern that SNFs with a sub-acute
unit will be at risk for reporting higher percentages of residents or
patients with pressure ulcers than SNFs that do not have a designated
sub-acute unit under the proposed measure.
Response: We agree that some SNF residents are at higher risk for
developing new or worsened pressure ulcers. However, pressure ulcers
are severe, life threatening, and high-cost adverse events, and many
SNF residents may have medically complex conditions that put them at
high risk for the development or worsening of pressure ulcers. Given
their impact on mortality, morbidity, and quality of life, we believe
that SNFs should be responsible for preventing and managing pressure
ulcers among both high and low risk residents or patients and that
facilities with certain types of patients should not be exempt from
reporting new or worsened pressure ulcers. In effort to account for the
added challenges that facilities with more high risk residents may
face, the proposed quality measure is risk adjusted for four risk
factors: (1) Functional limitation, (2) bowel incontinence, (3)
diabetes or peripheral vascular disease/peripheral arterial disease,
and (4) low body mass index (BMI).
Comment: Many commenters encouraged CMS to align measures where
possible with existing CMS initiatives, across settings, and payments
types.
Response: We strive to harmonize and align quality measures across
initiatives, settings, and payment types whenever possible and will
continue to do so as we develop and implement quality measures under
the IMPACT Act.
Final Decision: Having carefully considered the comments we
received on the quality measure, the Percent of Residents or Patients
with Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678),
we are finalizing the adoption of this measure for use in the SNF QRP.
As part of our ongoing measure development efforts, we are
considering a future update to the numerator of the quality measure,
the Percent of Residents or Patients with Pressure Ulcers that are New
or Worsened (Short Stay) (NQF #0678). This update would require PAC
providers to report the development of unstageable pressure ulcers,
including suspected deep tissue injuries (sDTIs). Under this potential
change we are considering, the numerator of the quality measure would
be updated to include unstageable pressure ulcers, including sDTIs that
are new/developed in the facility, as well as Stage 1 or 2 pressure
ulcers that become unstageable due to slough or eschar (indicating
progression to a stage 3 or 4 pressure ulcer) after admission. SNFs are
already required to complete the unstageable pressure ulcer items on
the MDS 3.0. As such, this update would require a change in the way the
measure is calculated but would not increase the data collection burden
for SNFs.
A TEP convened by our measure development contractor strongly
recommended that CMS update the specifications for the measure to
include these pressure ulcers in the numerator, although it
acknowledged that unstageable pressure ulcers and sDTIs cannot and
should not be assigned a numeric stage. The TEP also recommended that a
Stage 1 or 2 pressure ulcer that becomes unstageable due to slough or
eschar should be
[[Page 46439]]
considered worsened because the presence of slough or eschar indicates
a full thickness (equivalent to Stage 3 or 4) wound.41 42
These recommendations were supported by technical and clinical advisors
and the National Pressure Ulcer Advisory Panel.\43\ Additionally,
exploratory data analysis conducted by our measure development
contractor suggests that the addition of unstageable pressure ulcers,
including sDTIs, will increase the observed incidence of new or
worsened pressure ulcers at the facility level and may improve the
ability of the quality measure to discriminate between poor- and high-
performing facilities.
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\41\ Schwartz, M., Nguyen, K.H., Swinson Evans, T.M., Ignaczak,
M.K., Thaker, S., and Bernard, S.L.: Development of a Cross-Setting
Quality Measure for Pressure Ulcers: OY2 Information Gathering,
Final Report. Centers for Medicare & Medicaid Services, November
2013. Available: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Development-of-a-Cross-Setting-Quality-Measure-for-Pressure-Ulcers-Information-Gathering-Final-Report.pdf.
\42\ Schwartz, M., Ignaczak, M.K., Swinson Evans, T.M., Thaker,
S., and Smith, L.: The Development of a Cross-Setting Pressure Ulcer
Quality Measure: Summary Report on November 15, 2013, Technical
Expert Panel Follow-Up Webinar. Centers for Medicare & Medicaid
Services, January 2014. Available: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Development-of-a-Cross-Setting-Pressure-Ulcer-Quality-Measure-Summary-Report-on-November-15-2013-Technical-Expert-Pa.pdf.
\43\ Schwartz, M., Nguyen, K.H., Swinson Evans, T.M., Ignaczak,
M.K., Thaker, S., and Bernard, S.L.: Development of a Cross-Setting
Quality Measure for Pressure Ulcers: OY2 Information Gathering,
Final Report. Centers for Medicare & Medicaid Services, November
2013. Available: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Development-of-a-Cross-Setting-Quality-Measure-for-Pressure-Ulcers-Information-Gathering-Final-Report.pdf.
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We invited public comments to inform our consideration of the
inclusion of unstageable pressure ulcers, including sDTIs in the
numerator of the quality measure, the Percent of Residents or Patients
with Pressure Ulcers that are New or Worsened (Short Stay) (NQF #0678)
as part of our future measure development efforts. The following is a
summary of the comments received and our responses.
Comment: One commenter supported our proposal to include
unstageable pressure ulcers and suspected deep tissue injuries in the
numerator of the proposed quality measure as an area for future measure
development. The commenter agreed that these cases should be included
in the measure population.
Response: As noted, the recommendation addresses an important
clinical concern, and may improve the ability of the quality measure to
discriminate between poor and high-performing facilities. As we
consider the possibility of adding unstageable pressure ulcers and
suspected deep tissue injuries to the numerator, we will carefully
consider all comments received from stakeholders.
Comment: Several commenters were supportive of our proposal to
include unstageable pressure ulcers (we interpret their comment as
referring to unstageable pressure ulcers due to slough or eschar and
due to non-removable dressing/device) in the numerator of the quality
measure as an area for future measure development, but expressed
reservations about the possible future inclusion of suspected deep
tissue injuries (sDTIs) in the numerator of the Percent of Residents or
Patients with Pressure Ulcers That Are New or Worsened (Short Stay)
(NQF #0678) quality measure. Commenters cited information from the
National Pressure Ulcer Advisory Council suggesting that sDTIs can take
between 72 hours and seven days to become visible, indicating that
there is no reliable and consistent way to determine whether an sDTI at
admission is facility acquired or not. Commenters also mentioned
confusion surrounding pressure ulcers that are unavoidable or times
when prevention is not possible. Finally, multiple commenters stated
that the time frame during which sDTIs become visible varies and there
is potential for miscoding, both of which may make this an unreliable
quality measure.
One commenter requested more information about how this change
would be incorporated into the measure specifications. The commenter
also requested more information regarding the impact this change would
have on the reliability and validity of the measure, as well as how it
may impact the risk adjustment methodology. Finally the commenter
encouraged CMS to submit any proposed changes through NQF review and
specify all details in future rule making. Commenters also encouraged
CMS to update the coding instructions for the RAI manual if this change
is made, apply this change across all PAC settings, and gather
additional stakeholder and expert input on this change prior to
implementation.
Response: We appreciate the recommendations regarding the approach
to future implementation. We will continue to conduct analyses and
solicit input before making any final decisions regarding this possible
change to the measure specifications. We intend to continue monitoring
the literature, conduct reliability and validity testing, seek input
from subject matter experts and stakeholders, and participate in
ongoing refinement activities to inform this measure before proposing
to adopt any changes. Should we move forward with the addition of
unstageable and sDTIs to the measure numerator, we intend to submit any
changes through NQF, provide information that will allow providers to
accurately interpret and complete quality reporting items, ensure that
the MDS 3.0 Resident Assessment Instrument Manual and training
materials provide accurate and up-to-date coding instructions for all
items, and seek public comment on future measure concepts or revisions.
In regard to the commenters' concerns regarding sDTIs, we believe
that it is important to do a thorough admission assessment on each
resident or patient who is admitted to a SNF, including a thorough skin
assessment documenting the presence of any pressure ulcers of any
kind--including sDTIs. When considering the addition of sDTIs to the
measure numerator, we convened cross-setting TEPs in June and November
2013, and obtained input from clinicians, experts, and other
stakeholders. While we agree that ongoing research is needed, sDTIs are
a serious medical condition and given their potential impact on
mortality, morbidity, and quality of life, it may be detrimental to the
quality of care to exclude them from future quality measures. We thank
the commenters for their feedback and we will take into account the
recommendations regarding the challenges in determining whether an sDTI
at admission is facility acquired or not, the difficulty in coding
sDTIs, and the confusion surrounding pressure ulcers that are
unavoidable or times when prevention is not possible.
Comment: One commenter did not support the addition of unstageable
pressure ulcers in the numerator of the Percent of Residents or
Patients with Pressure Ulcers That Are New or Worsened (Short Stay)
(NQF #0678) quality measure. The commenter was concerned that the
measure timeframe is too short to properly capture pressure ulcer
improvement, disadvantaging facilities that serve more frail
populations. The commenter indicated that capturing a healed
unstageable pressure ulcer is particularly difficult as SNFs have a
very limited amount of time from admission to the end of a short-stay
episode to heal a pressure ulcer.
Response: We will take all stakeholder feedback into account as we
consider the possibility of including unstageable pressure ulcers,
including
[[Page 46440]]
sDTIs in the numerator of the quality measure in the future.
(2) Quality Measure Addressing the Domain of the Incidence of Major
Falls: An Application of the Measure Percent of Residents Experiencing
One or More Falls with Major Injury (Long Stay) (NQF #0674)
We proposed to adopt beginning with the FY 2018 SNF QRP, an
application to the SNF setting of the Percent of Residents Experiencing
One or More Falls with Major Injury (Long Stay) (NQF #0674) measure
that satisfies the incidence of major falls domain. This outcome
measure reports the percentage of residents who have experienced falls
with major injury during episodes ending in a 3-month period. This
measure was developed by CMS and is NQF-endorsed for long-stay
residents of NFs.
Research indicates that fall-related injuries are the most common
cause of accidental death in people aged 65 and older, responsible for
approximately 41 percent of accidental deaths annually.\44\ Rates
increase to 70 percent of accidental deaths among individuals aged 75
and older.\45\ In addition to death, falls can lead to fracture, soft
tissue or head injury, fear of falling, anxiety, and depression.\46\
Research also indicates that approximately 75 percent of nursing
facility residents fall at least once a year. This is twice the rate of
their counterparts in the community.\47\ Further, it is estimated that
10 percent to 25 percent of nursing facility resident falls result in
fractures and/or hospitalization.\48\
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\44\ Currie LM. Fall and injury prevention. Annu Rev Nurs Res.
2006;24:39-74.
\45\ Fuller GF. Falls in the elderly. Am Fam Physician. Apr 1
2000;61(7):2159-2168, 2173-2154.
\46\ Love K, Allen J. Falls: why they matter and what you can
do. Geriatr Nurs, 2011; 32(3): 206-208.
\47\ Rubenstein LZ, Josephson KR, Robbins AS. Falls in the
nursing home. Ann Intern Med. 1994 Sep 15; 121(6):442-51.
\48\ Vu MQ, Weintraub N, Rubenstein LZ. Falls in the nursing
home: are they preventable? J Am Med Dir Assoc. 2004 Nov-Dec;
5(6):401-6. Review.
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Falls also represent a significant cost burden to the entire health
care system, with injurious falls accounting for 6 percent of medical
expenses among those age 65 and older.\49\ In one study, Sorensen et
al. estimated the costs associated with falls of varying severity among
nursing home residents.\50\ Their work suggests that acute care costs
incurred for falls among nursing home residents range from $979 for a
typical case with a simple fracture to $14,716 for a typical case with
multiple injuries. A similar study of hospitalizations of nursing home
residents due to serious fall-related injuries (intracranial bleed, hip
fracture, other fracture) found an average cost of $23,723.\51\ Among
the SNF population, the average 6-month cost of a resident with a hip
fracture was estimated at $11,719 in 1996 U.S. dollars.\52\
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\49\ Tinetti ME, Williams CS. The effect of falls and fall
injuries on functioning in community-dwelling older persons. J
Gerontol A Biol Sci Med Sci. 1998 Mar;53(2):M112-9.
\50\ Sorensen SV, de Lissovoy G, Kunaprayoon D, Resnick B,
Rupnow MF, Studenski S. A taxonomy and economic consequence of
nursing home falls. Drugs Aging. 2006;23(3):251-62.
\51\ Quigley PA, Campbell RR, Bulat T, Olney RL, Buerhaus P,
Needleman J. Incidence and cost of serious fall-related injuries in
nursing homes. Clin Nurs Res. Feb 2012;21(1):10-23.
\52\ Kramer AM, Steiner JF, Schlenker RE, et al. Outcomes and
costs after hip fracture and stroke: a comparison of rehabilitation
settings. JAMA. 1997;277(5):396-404.
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According to Morse, 78 percent of falls are anticipated physiologic
falls, which are falls among individuals who scored high on a risk
assessment scale, meaning their risk could have been identified in
advance of the fall.\53\ To date, studies have identified a number of
risk factors for falls.54 55 56 57 58 59 60 61 62 The
identification of such risk factors suggests the potential for health
care facilities to reduce and prevent the incidence of falls. The
Percent of Residents Experiencing One or More Falls with Major Injury
(Long Stay) (NQF #0674) quality measure is NQF-endorsed and has been
successfully implemented in the Nursing Home Quality Initiative for
nursing facility long-stay residents since 2011. In addition, the
quality measure is currently publicly reported on CMS's Nursing Home
Compare Web site at https://www.medicare.gov/nursinghomecompare/search.html. Further, an application of the quality measure was adopted
for use in the LTCH QRP in the FY 2014 IPPS/LTCH PPS final rule (78 FR
50874 through 50877). In the FY 2015 IPPS/LTCH PPS final rule (79 FR
50290), we revised the data collection period for this measure with
data collection to begin starting April 1, 2016.
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\53\ Morse, J. M. (2002) Enhancing the safety of hospitalization
by reducing patient falls. Am J Infect Control 2002; 30(6): 376-80.
\54\ Rothschild JM, Bates DW, Leape LL. Preventable medical
injuries in older patients. Arch Intern Med. 2000 Oct 9;
160(18):2717-28.
\55\ Morris JN, Moore T, Jones R, et al. Validation of long-term
and post-acute care quality indicators. CMS Contract No: 500-95-
0062/T.O. #4. Cambridge, MA: Abt Associates, Inc., June 2003.
\56\ Avidan AY, Fries BE, James ML, Szafara KL, Wright GT,
Chervin RD. Insomnia and hypnotic use, recorded in the minimum data
set, as predictors of falls and hip fractures in Michigan nursing
homes. J Am Geriatr Soc. 2005 Jun; 53(6):955-62.
\57\ Fonad E, Wahlin TB, Winblad B, Emami A, Sandmark H. Falls
and fall risk among nursing home residents. J Clin Nurs. 2008 Jan;
17(1):126- 34.
\58\ Currie LM. Fall and injury prevention. Annu Rev Nurs Res.
2006; 24:39-74.
\59\ Ellis AA, Trent RB. Do the risks and consequences of
hospitalized fall injuries among older adults in California vary by
type of fall? J Gerontol A Biol Sci Med Sci. Nov 2001; 56(11):M686-
692.
\60\ Chen XL, Liu YH, Chan DK, Shen Q, Van Nguyen H. Chin Med J
(Engl). Characteristics associated with falls among the elderly
within aged care wards in a tertiary hospital: a retrospective. 2010
Jul; 123(13):1668-72.
\61\ Frisina PG, Guellnitz R, Alverzo J. A time series analysis
of falls and injury in the inpatient rehabilitation setting. Rehabil
Nurs. 2010 JulAug; 35(4):141-6, 166.
\62\ Lee JE, Stokic DS. Risk factors for falls during inpatient
rehabilitant Am J Phys Med Rehabil. 2008 May; 87(5):341-50; quiz
351, 422.
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Although the quality measure, the Percent of Residents Experiencing
One or More Falls with Major Injury (Long Stay) (NQF #0674) is not
currently endorsed for the SNF setting, we reviewed the NQF's consensus
endorsed measures and were unable to identify any NQF-endorsed cross-
setting quality measures for that setting that are focused on falls
with major injury. We are aware of one NQF-endorsed measure, Falls with
Injury (NQF #0202), which is a measure designed for adult acute
inpatient and rehabilitation patients capturing ``all documented
patient falls with an injury level of minor or greater on eligible unit
types in a calendar quarter, reported as injury falls per 100 days.''
\63\ NQF #0202 is not appropriate to meet the IMPACT Act domain as it
includes minor injury in the numerator definition. Additionally,
including all falls could result in providers limiting the freedom of
activity for individuals at higher risk for falls. We are unaware of
any other cross-setting quality measures for falls with major injury
that have been endorsed or adopted by another consensus organization
for the SNF setting. Therefore, we proposed to adopt this measure under
the Secretary's authority to specify non-NQF-endorsed measures under
section 1899B(e)(2)(B) of the Act.
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\63\ American Nurses Association (2014, April 9). Falls with
injury. Retrieved from https://www.qualityforum.org/QPS/0202.
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A TEP convened by our measure development contractor provided input
on the technical specifications of an application of the quality
measure, the Percent of Residents Experiencing One or More Falls with
Major Injury (Long Stay) (NQF #0674), including the feasibility of
implementing the measure across PAC settings. The TEP was supportive of
the implementation of this measure across PAC settings and was also
supportive of our efforts to standardize this measure for cross-
[[Page 46441]]
setting development. The MAP conditionally supported the use of an
application of the quality measure, the Percent of Residents
Experiencing One or More Falls with Major Injury (Long Stay) (NQF
#0674) in the SNF QRP as a cross-setting quality measure. More
information about the MAP's recommendations for this measure is
available in the report entitled MAP Off-Cycle Deliberations 2015:
Measures under Consideration to Implement Provisions of the IMPACT Act
are available at https://www.qualityforum.org/Project_Pages/MAP_Post-Acute_CareLong-Term_Care_Workgroup.aspx.
More information on the NQF-endorsed quality measure, the Percent
of Residents Experiencing One or More Falls with Major Injury (Long
Stay) (NQF #0674) is available at https://www.qualityforum.org/QPS/0674.
We proposed that data for this quality measure would be collected
using the MDS 3.0, currently submitted by SNFs through the QIES ASAP
system for the reason noted previously.
The data items that we will use to calculate this proposed quality
measure include: J1800 (Any Falls Since Admission/Entry (OBRA or
Scheduled PPS) or Reentry or Prior Assessment, whichever is more
recent); and J1900 (Number of Falls Since Admission/Entry (OBRA or
Scheduled PPS) or Reentry or Prior Assessment, whichever is more
recent). This measure will be calculated at the time of discharge (see
Proposed Form, Manner, and Timing of Quality Data Submission). The
specifications for an application of the quality measure, the Percent
of Residents Experiencing One or More Falls with Major Injury (Long
Stay) (NQF #0674) for the SNF population are available on our SNF QRP
measures and technical Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html.
We referred readers to the Form, Manner, and Timing of Quality Data
Submission section of the FY 2016 SNF PPS proposed rule (79 FR 22076
through 22077) for more information on the proposed data collection and
submission timeline for this proposed quality measure.
We invited public comments on our proposal to adopt an application
of the quality measure, the Percent of Residents Experiencing One or
More Falls with Major Injury (Long Stay) (NQF #0674) for the SNF QRP
beginning with the FY 2018 payment determination. The comments we
received on this topic, with their responses, appear below.
Comment: Several commenters supported our proposal to implement an
application of the quality measure, the Percent of Residents
Experiencing One or More Falls with Major Injury (Long Stay) (NQF
#0674) to fulfill the requirements of the IMPACT Act.
Response: We thank the commenters for their support.
Comment: One commenter supported measuring falls in SNFs, but
stated a preference for measuring falls ``with or without injury'' and
``assisted or non-assisted'' and tracking by preventable falls
(resident-related or environment-and other-related) and non-preventable
(resident conditions like fainting).
Response: The proposed application of the quality measure, the
Percent of Residents Experiencing One or More Falls with Major Injury
(Long Stay) (NQF #0674) assesses falls with major injuries, satisfying
the domain in section 1899B(c)(1)(D) of the Act, the Incidence of Major
Falls. We believe this domain mandates a quality measure related to
falls with major injury. We agree that a provider's tracking of falls
is important for the purpose of ensuring resident safety. The
information suggested by the commenter for collection is already
included in the MDS 3.0 enabling SNFs to track all falls, regardless of
injury by including items indicating the number of falls with and
without injury. The data elements used to track all falls, including
major injury, J1800, J1900 A, B and C, are collected to ensure the
reliability of the data. We note that Measure #0674 has been NQF-
endorsed based on the manner in which it is calculated now, and its
inter-rater reliability is based on the data collection of J1900 A, B
and C. The measure has been tested, validated, and endorsed as it is
currently collected, and to maintain our current accuracy, we have
proposed to maintain those methods.
Comment: Several comments supported the addition of the proposed
quality measure to the SNF QRP, but urged that the measure be risk
adjusted, expressing concerns that public reporting of falls with
injury rates across settings would be inappropriate without taking into
account differences in resident acuity and other characteristics, such
as cognition and socioeconomic status. One commenter stated that falls
occur for various reasons, some of them unavoidable, and therefore,
fall rates may not be suitable for quality comparison suggesting that
it would be improper to use the measure in pay-for performance models.
Another commenter suggested that falls with major injuries ``are a
never event'' (that is, events or medical errors that should never
transpire, such as falls that happen in a health care setting that
result in patient death or serious injury[).\64\ Another commenter
cited American and British Geriatrics Society guidelines, which find no
clear evidence on falls prevention. Some commenters pointed out that
the TEP convened in 2015 recommended risk adjustment for cognitive
impairment, which several commenters also supported, and one commenter
asked whether the TEP was presented the current specifications of the
cross-setting falls measure. One commenter provided support for risk
adjustment by pointing out that the references cited in the proposed
rule indicate that risks for falls vary by resident characteristics,
that the State Operations Manual (SOM) for SNFs provides guidance for
evaluating residents for risk for falls, and that documentation for not
risk adjusting the measure was not provided in the proposed rule. The
same commenter pointed to the PAC Payment Reform Demonstration (PAC
PRD), in which the commenter stated that the research indicated that
the risk of falls with injury differs across post-acute settings.
Several commenters also stated that risk adjustment is required by the
IMPACT Act, and that the MAP suggested that the measure should be risk
adjusted.
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\64\ National Quality Forum (NQF), Serious Reportable Events In
Healthcare--2011 Update: A Consensus Report, Washington, DC: NQF;
2011.
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Response: We appreciate the commenters' suggestions that the
proposed application of the quality measure, the Percent of Residents
Experiencing One or More Falls with Major Injury (Long Stay) (NQF
#0674) should be risk adjusted. The application of risk adjustment, as
stated by the IMPACT Act, is ``as determined appropriate by the
Secretary'' under section 1899B(c)(3)(B) of the Act.
While we acknowledge that resident characteristics that elevate
risk for falls with major injury vary across the SNF population, a TEP
convened in 2009 by the measurement development contractor concluded
that risk adjustment of this quality measure concept was inappropriate
because it is each facility's responsibility to take steps to reduce
the rate of injurious falls, especially since such events are
considered to be ``never events.'' We note that the PAC PRD did not
analyze falls with major injury, as falls with major injury was not an
assessment item that was tested. However, as the commenter pointed out,
the prevalence
[[Page 46442]]
of a history of falls prior to the PAC admission did vary across post-
acute settings (as assessed by Item B7 from the CARE tool: ``History of
Falls. Has the patient had two or more falls in the past year or any
fall with injury in the past year? ''). Nonetheless, we believe that as
part of best clinical practice, SNFs should assess residents for falls
risk and take steps to prevent future falls with major injury.
The numerator, denominator, and exclusions definitions provided to
the TEP in 2015 are virtually identical to the specifications we
proposed to adopt for this measure, and did not include risk
adjustment. Two out of 11 members of the 2015 TEP supported risk
adjustment of the falls measure for cognitive impairment, but it was
not the majority position. For more information on the 2015 TEP, please
visit https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/SUMMARY-OF-FEEDBACK-FROM-THE-TECHNICAL-EXPERT-PANEL-TEP-REGARDING-CROSS-SETTING-MEASURES-ALIGNED-WITH-THE-IMPACT-ACT-OF-2014-Report.pdf.
We believe factors that increase the risk of falling, such as
cognitive impairment, should be included by facilities in their risk
assessment to support proper care planning. As cited in the proposed
rule, research suggests that 78 percent of falls are anticipated falls,
occurring in individuals who could have been identified as at-risk for
a fall using a risk-assessment scale. Risk adjusting for falls with
major injury could unintentionally lead to insufficient risk prevention
by the provider. As required by the Deficit Reduction Act of 2007, the
Hospital Acquired Conditions-Present On Admission (HAC-POA) Indicator
Reporting provision requires a quality adjustment in the Medicare
Severity-Diagnosis Related Groups (MS-DRG) payments for certain HACs,
which include falls and trauma, and these payment reductions are not
risk adjusted. Furthermore, we note that the State Operations Manual
(SOM) provides guidance for SNFs to assess resident risk for falls with
the intent to aid providers in prevention of falls. The need for risk
assessment, based on varying risk factors among residents, does not
remove the obligation of providers to minimize that risk.
With regard to the MAP recommendation to risk adjust this measure
cited by the commenter, the MAP feedback regarding risk adjustment for
this quality measure applied to the home health setting, not to the SNF
setting. We also refer readers to a more recent Cochrane review of 60
randomized controlled trials, which found that within care facilities,
multifactorial interventions have the potential to reduce rates of
falls and risk of falls.\65\
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\65\ Cameron ID, Gillespie LD, Robertson MC, Murray GR, Hill KD,
Cumming RG, Kerse N. Interventions for preventing falls in older
people in care facilities and hospitals. Cochrane Database of
Systematic Reviews 2012, Issue 12. Art. No.: CD005465. DOI: 10.1002/
14651858.CD005465.pub3.
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Comment: One commenter requested that CMS consider risk adjusting
the proposed application of the quality measure, the Percent of
Residents Experiencing One or More Falls with Major Injury (Long Stay)
(NQF #0674) for sociodemographic status, to better reflect the
realities that affect the care of special populations and the need for
coordination with hospitals within a geographic region. The commenter
suggested that some beneficiaries in certain populations are more
complex and therefore, their risk for falls resulting in major injuries
may increase.
Response: While we appreciate these comments and the importance of
the role that sociodemographic status plays in the care of patients, we
continue to have concerns about holding providers to different
standards for the outcomes of their patients of low sociodemographic
status because we do not want to mask potential disparities or minimize
incentives to improve the outcomes of disadvantaged populations. We
routinely monitor the impact of sociodemographic status on facilities'
results on our measures.
NQF is currently undertaking a two-year trial period in which new
measures and measures undergoing maintenance review will be assessed to
determine if risk-adjusting for sociodemographic factors is appropriate
for each measure. For two-years, NQF will conduct a trial of a
temporary policy change that will allow inclusion of sociodemographic
factors in the risk-adjustment approach for some performance measures.
At the conclusion of the trial, NQF will determine whether to make this
policy change permanent. Measure developers must submit information
such as analyses and interpretations as well as performance scores with
and without sociodemographic factors in the risk adjustment model.
Furthermore, the ASPE is conducting research to examine the impact
of socioeconomic status on quality measures, resource use, and other
measures under the Medicare program as directed by the IMPACT Act. We
will closely examine the findings of these reports and related
Secretarial recommendations and consider how they apply to our quality
programs at such time as they are available.
Comment: One commenter believed that collecting data on falls would
be burdensome for residents who are on the unit for only part of a day.
Another commenter recommended shortening the discharge assessment to
only include necessary information to decrease the data collection
burden.
Response: We appreciate the commenter's position that tracking
falls for residents who are on the unit for only part of a day could be
burdensome. However, given that facilities are responsible for
residents' safety regardless of location within the facility or
duration of time spent in various units, if a resident experiences an
injurious fall, no matter their location in the facility, that fall
will need to be tracked and reported. Moreover, data on falls are
already collected in the MDS, so the additional burden associated with
this measure is minimal. We note that the SNF PPS Part A Discharge
assessment is limited to just the items necessary to calculate the
three SNF QRP measures proposed in this rule to minimize any additional
burden.
Comment: Several commenters supported the measure's addition to the
SNF QRP, but expressed concerns about the measure not having been
adequately tested in the short-stay or SNF population. Additionally,
several commenters expressed concerns regarding the lack of NQF
endorsement for an application of the quality measure, the Percent of
Residents Experiencing One or More Falls with Major Injury (Long Stay)
(NQF #0674) as a cross-setting measure for SNF, IRF and LTCH QRPs.
Other commenters mentioned that the MAP conditionally supported this
measure pending NQF endorsement.
Response: We thank the commenters for their support of the measure
and suggested changes to the measure. We also appreciate the
commenters' concerns pertaining the adequacy of the measure's testing
for use in the short-stay or SNF population, which we interpret to mean
adequacy regarding the reliability and validity of the proposed
application of the quality measure, the Percent of Residents
Experiencing One or More Falls with Major Injury (Long Stay) (NQF
#0674) and the items used to calculate the measure in the SNF setting.
This proposed measure is a cross-setting measure that we believe
satisfies the measure required under section 1899B(c)(1)(D) of the Act
domain, Incidence of Major Falls. For the reasons
[[Page 46443]]
provided previously, we proposed this measure under the exception
authority provided in section 1899B(e)(2)(B) of the Act, which allows
CMS to apply a measure to the SNF setting that is not NQF-endorsed as
long as due consideration is given to measures that have been endorsed
or adopted by a consensus organization.
With regard to the adequacy of the measure's testing for use in the
short-stay or SNF population, the item-level testing during the
development of the MDS 3.0 showed near-perfect inter-rater reliability
for the MDS item (J1900C) used to identify falls with major injury;
therefore, we disagree with the commenter's suggestion as to the
strength of the item-level testing.\66\ The NQF measure evaluation
criteria do not require measure level reliability if item reliability
is high.\67\ However, we believe that, given the overlap in the
populations and item-level testing results, the application of this
measure for SNF residents will be reliable. That said, we intend to
continue to test the measure once data collection begins as part of
ongoing maintenance of the measure. We also note that a TEP convened in
2009 supported measuring falls with major injury in PAC settings
regardless of the length of stay of the resident. The TEP also
concurred that facilities need to take responsibility to not only
prevent falls but to ensure that if they do occur, protections are in
place so that the fall does not result in injury.
---------------------------------------------------------------------------
\66\ Saliba D. and Buchanan J. (2008). Development and
Validation of a Revised Nursing Home Assessment Tool: MDS 3.0.
Contract No. 500-00-0027/Task Order #2. Santa Monica, CA: Rand
Corporation. Retrieved from https://www.cms.hhs.gov/NursingHomeQualityInits/Downloads/MDS30FinalReport.pdf; https://www.geronet.med.ucla.edu/centers/borun/Appendix_A-G.pdf.
\67\ NQF. Measure Evaluation Criteria and Guidance for
Evaluating Measures for Endorsement. April 2015. Available online
at: https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=79434.
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Comment: One commenter urged CMS to provide clarification in the
final rule about the use of current falls MDS 3.0 data items under the
SNF QRP. Others requested clarification on the measure specifications,
stating that the specifications for how this measure will be
constructed using admission and discharge assessments are unclear. Two
commenters requested clarification about whether the numerator includes
falls with and without injury. Another commenter asked if OBRA
assessments are considered in the look-back scan and whether both long-
stay and short-stay residents are included in the measure. One
commenter requested that CMS clarify how the addition of the MDS
discharge assessment will affect the measure specifications for the
numerator and denominator of the falls measure. The commenter noted
that CMS proposes modifying the MDS discharge assessment to collect
information for Part A FFS Medicare beneficiaries who continue in the
SNF after ending their SNF Part A covered stay, but does not clarify
how this change will be implemented in the proposed falls measure. That
commenter was concerned that if this new MDS discharge assessment is
not included, the measure will exclude individuals who are admitted but
not discharged from the SNF during their PAC stay and limit CMS'
ability to provide meaningful information to both PAC providers and
consumers.
Response: To clarify, the proposed quality measure will be
calculated for the purposes of the SNF QRP on residents receiving
services under a SNF Part A covered stay. To further clarify, although
this measure is based on the data collection of two items, the
numerator and denominator only use one item: the number of falls with
major injury. The assessment instrument includes an item about whether
any fall took place (J1800) as a gateway item. If there were any falls,
the assessor then completes the next set of items (J1900) indicating
the number of falls by injury status. Facilities must report the data
associated with all these items in order to avoid issues with missing
data and as a way to ensure accurate data collection, but only the data
on falls with major injury are used in calculating the measure.
We also want to clarify that the items used to calculate the
measure are already included on the existing MDS 3.0 item sets, for
example, both OBRA and PPS assessments. The necessary falls items will
also be added to the proposed SNF PPS Part A Discharge assessment to
ensure the capture of falls with major injury at the end of the SNF
Part A covered stay for residents who continue in the SNF after ending
their SNF Part A covered stay.
Other than the proposed SNF PPS Part A Discharge assessment, the
implementation of the proposed application of the quality measure, the
Percent of Residents Experiencing One or More Falls with Major Injury
(Long Stay) (NQF #0674) does not represent new data collection for
SNFs. SNFs have been submitting data for these items as part of the
Nursing Home Quality Initiative since October 2010.
We note that specifications for the application of the quality
measure, the Percent of Residents Experiencing One or More Falls with
Major Injury (Long Stay) (NQF #0674) for the SNF population are
available on our SNF QRP measures and technical Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html. The specifications include
information on how the SNF PPS Part A Discharge will be used in the
measure, and specify that the measure will apply to both long- and
short-stay Medicare FFS beneficiaries as long as they have had a SNF
PPS Part A covered stay.
Comment: Several commenters expressed concerns about the falls
measure not being standardized across PAC settings. One commenter
stated that the measure should have the same wording, timeframe, and
item set across all PAC settings, and that the denominator and
exclusions should be the same; they also specifically noted differences
in the payers that are required to report data for this measure. Two
commenters objected to the exclusion of Medicare Advantage
beneficiaries from the numerator and denominator for this measure. One
commenter noted that measures based on only Medicare FFS beneficiaries
may be incomplete, since, according to some estimates, only about half
of SNF residents are covered by Medicare FFS.
Another commenter asked about the extent to which the time horizon
(that is, the time period during which the measure will be calculated)
will differ across settings, and another suggested that the exclusions
listed in the specifications were different in different settings. One
comment mistakenly asserted that the item used in the equivalent IRF
specifications asks about the occurrence of two or more falls in the
past year and whether a patient had major surgery, in contrast to the
SNF specifications for the measure. Another commenter expressed concern
regarding differences in the populations across quality measures in the
SNF QRP. The commenters mentioned that the falls measure (NQF #0674)
and function measure (NQF #2631) include only Medicare FFS residents,
while the pressure ulcer measure (NQF #0678) includes all short-stay
SNF residents. The commenter mentioned that this inconsistency could
result in confusion for providers because of the varying denominators
across measures.
Response: CMS appreciates the commenters' comments pertaining to
the differences in the quality measure denominators by payer type
across the IRF, SNF and LTCH settings. As previously stated, we believe
that
[[Page 46444]]
quality care is best represented through the inclusion of all patient
data regardless of payer source. We agree that consistency in the data
would reduce confusion in data interpretation and enable a more
comprehensive evaluation of quality and although we had not proposed
all payer data collection through this current rulemaking, we will take
into consideration the expansion of the SNF QRP to include all payer
sources through future rulemaking.
We appreciate the comment pertaining to consistent data collection
across the reporting programs. We believe that quality measures that
include all residents in a facility are better able to capture the
health outcomes of that facility's residents, and thus, including all
residents in quality reporting is important. Regarding expansion of the
population used to calculate this measure to include payer sources
beyond Medicare Part A, we agree with the commenter's position and
intend to take this under consideration through future measure
development and rulemaking.
We wish to clarify that this falls measure is not currently used
for the short-stay nursing home population as part of Nursing Home
Compare and that this measure will be calculated using only Medicare
Part A data collected by the SNF.
With regard to the use of standardized items for this measure,
until now, the post-acute assessment instruments have not included
standardized items for falls with major injury. Although the quality
measure, an Application of Percent of Residents Experiencing One or
More Falls with Major Injury (Long Stay) (NQF #0674), and the data
collection items used to calculate this measure are harmonized across
settings and assessment instruments, we believe that there are
constraints in current data collection (that is, use of only admission
and discharge assessments in IRFs and LTCHs vs. admission/re-entry,
interim, and discharge assessments in SNFs.). For the purposes of
measure calculation, we are able to compensate for this data collection
approach to ensure a uniform application of the measure where currently
practicable for providers and feasible for the measure so that we have
harmonized the measure's calculation across all PAC settings. Although
we believe that we have applied the measure consistently across the
programs, to enable efficiencies in the measure's calculation, we
intend to address any outstanding standardization issues through future
rulemaking.
We would like to clarify that the occurrence of two or more falls
in the past year and major surgery prior to admission are risk-
adjusters for the function outcomes measures proposed in the FY 2016
IRF PPS proposed rule and are not related to the cross-setting falls
measure, and therefore, are not included in SNF QRP version of the
falls measure. We also wish to clarify that as proposed, the
application of this measure for the SNF QRP will include a look-back
from the time of discharge from the SNF Part A covered stay to the time
of admission, so that the measure's calculation and time frame used
will be consistent with the other QRPs. We note that the assessment at
discharge is an actual discharge from the facility or a discharge from
the SNF Part A covered stay with a transition in place. We also
disagree that the exclusions listed in the measure specification for
each setting are not standardized. Specifically, all three settings
only exclude cases due to missing data.
Comment: One commenter supported this measure, but expressed
concerns about the accuracy of the data on which the fall measure is
calculated, noting that a recent survey identified deficiencies in
reporting by a small sample of SNFs. One commenter expressed concerns
regarding the fact that CMS excludes residents for whom missing data
precludes calculation of the measure from the measure calculations. The
commenter expressed concerns that this exclusion may encourage gaming,
because if a facility recognizes that a resident is declining, it can
simply omit some data for that resident, ensuring that the resident is
excluded from the measure calculation. The commenter referenced several
different media reports, which highlight the seriousness of gaming of
MDS 3.0 data.
Response: We have proposed and are finalizing a threshold for
reporting of actual resident data for determinations. We also intend to
carefully monitor rates of missing data across all facilities.
Specifically, we have proposed and are now finalizing that for FY 2018
SNF QRP, any SNF that does not meet the requirement that 80 percent of
all MDS assessments submitted contain 100 percent of all data items
necessary to calculate the SNF QRP measures would be subject to a
reduction of 2 percentage points to its FY 2018 market basket
percentage. We hope this requirement will provide incentives to
providers to submit complete MDS 3.0 assessments. Further, we intend to
align with other QRPs and propose through future rulemaking to
implement a data validation program. Historically, rates of missing
data for the items used to calculated for the NHQI falls measure in
nursing homes have averaged less than 0.01 percent across all target
assessments in a given quarter (for example, the rate of missing data
in Q3 2014 was 0.004 percent), suggesting that missing data is minimal.
Further, we intend to align with other QRPs and propose through future
rulemaking a process and program surrounding data validation.
Comment: One commenter expressed concerns about providers being
penalized for resident-centered care practices, such as allowing frail
residents to ambulate without help.
Response: We fully support resident-centered care and enabling all
residents to make informed decisions about their care. However,
providers are responsible for resident safety, and falls with major
injury are considered ``never events.'' Thus, providers must balance
the desire to allow residents full autonomy with the need to care for
their well-being, including appropriate care planning and taking steps
to reduce injurious falls.
Having carefully considered the comments we received on the
application of the Percent of Residents Experiencing One or More Falls
with Major Injury (Long Stay) (NQF #0674) measure, we are finalizing
the adoption of this measure for use in the SNF QRP.
(3) Quality Measure Addressing the Domain of Functional Status,
Cognitive Function, and Changes in Function and Cognitive Function:
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; Endorsed on July 23, 2015)
We proposed to adopt, beginning with the FY 2018 SNF QRP, an
application of the quality measure Percent of Long-Term Care Hospital
Patients with an Admission and Discharge Functional Assessment and a
Care Plan that Addresses Function (NQF #2631; endorsed on July 23,
2015) as a cross-setting quality measure that satisfies the functional
status, cognitive function, and changes in functional status and
cognitive function domain. This quality measure reports the percent of
patients or residents with both an admission and a discharge functional
assessment and an activity (self-care or mobility) goal that addresses
function. The new self-care and mobility items are included in a new
section of the MDS titled, Section GG.
The National Committee on Vital and Health Statistics' Subcommittee
on
[[Page 46445]]
Health,\68\ noted that ``[i]nformation on functional status is becoming
increasingly essential for fostering healthy people and a healthy
population. Achieving optimal health and well-being for Americans
requires an understanding across the life span of the effects of
people's health conditions on their ability to do basic activities and
participate in life situations in other words, their functional
status.'' This is supported by research showing that patient and
resident functioning is associated with important outcomes such as
discharge destination and length of stay in inpatient settings,\69\ as
well as the risk of nursing home placement and hospitalization of older
adults living in the community.\70\
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\68\ Subcommittee on Health National Committee on Vital and
Health Statistics, ``Classifying and Reporting Functional Status''
(2001).
\69\ Reistetter TA, Graham JE, Granger CV, Deutsch A,
Ottenbacher KJ. Utility of Functional Status for Classifying
Community Versus Institutional Discharges after Inpatient
Rehabilitation for Stroke. Archives of Physical Medicine and
Rehabilitation, 2010; 91:345-350.
\70\ Miller EA, Weissert WG. Predicting Elderly People's Risk
for Nursing Home Placement, Hospitalization, Functional Impairment,
and Mortality: A Synthesis. Medical Care Research and Review, 57; 3:
259-297.
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The majority of individuals who receive PAC services, including
care provided by SNFs, HHAs, IRFs, and LTCHs, have functional
limitations and many of these individuals are at risk for further
decline in function due to limited mobility and ambulation.\71\ The
patient and resident populations treated by SNFs, HHAs, IRFs, and LTCHs
vary in terms of their functional abilities at the time of the PAC
admission and their goals of care. For IRF patients and many SNF
residents, treatment goals may include fostering the person's ability
to manage his or her daily activities so that he or she can complete
self-care and/or mobility activities as independently as possible, and
if feasible, return to a safe, active, and productive life in a
community-based setting. For home health patients, achieving
independence within the home environment and promoting community
mobility may be the goal of care. For other home care patients, the
goal of care may be to slow the rate of functional decline in order to
allow the person to remain at home and avoid institutionalization.\72\
Lastly, in addition to having complex medical care needs for an
extended period of time, LTCH patients often have limitations in
functioning because of the nature of their conditions, as well as
deconditioning due to prolonged bed rest and treatment requirements
(for example, ventilator use). The clinical practice guideline
Assessment of Physical Function \73\ recommends that clinicians
document functional status at baseline and over time to validate
capacity, decline, or progress. Therefore, assessment of functional
status at admission and discharge and establishing a functional goal
for discharge as part of the care plan is an important aspect of
patient or resident care in all of these PAC settings.
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\71\ Kortebein P, Ferrando A, Lombebeida J, Wolfe R, Evans WJ.
Effect of 10 days of bed rest on skeletal muscle in health adults.
JAMA; 297(16):1772-4.
\72\ Ellenbecker CH, Samia L, Cushman MJ, Alster K. Patient
safety and quality in home health care. Patient Safety and Quality:
An Evidence-Based Handbook for Nurses. Vol 1.
\73\ Kresevic DM. Assessment of physical function. In: Boltz M,
Capezuti E, Fulmer T, Zwicker D, editor(s). Evidence-based geriatric
nursing protocols for best practice. 4th ed. New York (NY): Springer
Publishing Company; 2012. p. 89-103.
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Given the variation in patient or resident populations across the
PAC settings, the functional activities that are typically assessed by
clinicians for each type of PAC provider may vary. For example, rolling
left and right in bed is an example of a functional activity that may
be most relevant for low-functioning patients or residents who are
chronically critically ill. However, certain functional activities such
as eating, oral hygiene, lying to sitting on the side of the bed,
toilet transfers, and walking or wheelchair mobility are important
activities for patients or residents in each PAC setting.
Although, functional assessment data are currently collected by all
four PAC providers and in NFs, this data collection has employed
different assessment instruments, scales, and item definitions. The
data cover similar topics, but are not standardized across PAC
settings. The different sets of functional assessment items coupled
with different rating scales makes communication about patient and
resident functioning challenging when patients and residents transition
from one type of setting to another. Collection of standardized
functional assessment data across SNFs, HHAs, IRFs, and LTCHs using
common data items would establish a common language for patient and
resident functioning, which may facilitate communication and care
coordination as patients and residents transition from one type of
provider to another. The collection of standardized functional status
data may also help improve patient and resident functioning during an
episode of care by ensuring that basic daily activities are assessed
for all PAC residents at the start and end of care and that at least
one functional goal is established.
The functional assessment items included in the proposed functional
status quality measure were originally developed and tested as part of
the Post-Acute Care Payment Reform Demonstration version of the
Continuity Assessment Record and Evaluation (CARE) Item Set, which was
designed to standardize the assessment of a person's status, including
functional status, across acute and post-acute settings (SNFs, HHAs,
IRFs, and LTCHs). The functional status items on the CARE Item Set are
daily activities that clinicians typically assess at the time of
admission and/or discharge in order to determine patient's or
resident's needs, evaluate patient or resident progress, and prepare
patients, residents, and their families for a transition to home or to
another setting.
The development of the CARE Item Set and a description and
rationale for each item is described in a report entitled ``The
Development and Testing of the Continuity Assessment Record and
Evaluation (CARE) Item Set: Final Report on the Development of the CARE
Item Set: Volume 1 of 3.'' \74\ Reliability and validity testing were
conducted as part of CMS's Post-Acute Care Payment Reform
Demonstration, and we concluded that the functional status items have
acceptable reliability and validity. A description of the testing
methodology and results are available in several reports, including the
report entitled ``The Development and Testing of the Continuity
Assessment Record And Evaluation (CARE) Item Set: Final Report On
Reliability Testing: Volume 2 of 3'' \75\ and the report entitled ``The
Development and Testing of The Continuity Assessment Record And
Evaluation (CARE) Item Set: Final Report on Care Item Set and Current
Assessment Comparisons: Volume 3 of 3.'' \76\ These reports are
available on our Post-Acute Care Quality Initiatives Web page at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/CARE-Item-Set-and-B-CARE.html.
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\74\ Barbara Gage et al., ``The Development and Testing of the
Continuity Assessment Record and Evaluation (CARE) Item Set: Final
Report on the Development of the CARE Item Set'' (RTI International,
2012).
\75\ Ibid.
\76\ Ibid.
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The functional status quality measure we proposed to adopt
beginning with the FY 2018 SNF QRP is a process quality measure that is
an application of the quality measure, Percent of Long-Term Care
Hospital Patients with an Admission and Discharge Functional Assessment
and a Care Plan that Addresses Function (NQF #2631; endorsed on July
23, 2015). This quality
[[Page 46446]]
measure reports the percent of patients or residents with both an
admission and a discharge functional assessment and a treatment goal
that addresses function.
This process measure requires the collection of admission and
discharge functional status data by clinicians using standardized
clinical assessment items, or data elements, which assess specific
functional activities, that is, self-care and mobility activities. The
self-care and mobility function activities are coded using a 6-level
rating scale that indicates the resident's level of independence with
the activity at both admission and discharge. A higher score indicates
more independence.
For this quality measure, there must be documentation at the time
of admission that at least one activity (function) goal is recorded for
at least one of the standardized self-care or mobility function items
using the 6-level rating scale. This indicates that an activity goal(s)
has been established. Following an initial assessment, the clinical
best practice would be to ensure that the resident's care plan
reflected and included a plan to achieve such an activity goal(s). At
the time of discharge, function is reassessed using the same 6-level
rating scale, enabling the ability to evaluate success in achieving the
resident's activity performance goals.
To the extent that a resident has an unplanned discharge, for
example, for the purpose of being admitted to an acute care facility,
the collection of discharge functional status data might not be
feasible. Therefore, for patients or residents with unplanned
discharges, admission functional status data and at least one treatment
goal must be reported, but discharge functional status data are not
required to be reported.
A TEP convened by the measure development contractor for CMS
provided input on the technical specifications of this quality measure,
including the feasibility of implementing the measure across PAC
settings. The TEP was supportive of the implementation of this measure
across PAC settings and was also supportive of our efforts to
standardize this measure for cross-setting use. Additionally, the MAP
conditionally supported the use of an application of the Percent of
Long-Term Care Hospital Patients With an Admission and Discharge
Functional Assessment and a Care Plan that Addresses Function (NQF
#2631; endorsed on July 23, 2015) for use in the SNF QRP as a cross-
setting measure. The MAP noted that this functional status measure
addresses an IMPACT Act domain and a MAP PAC/LTC core concept. The MAP
conditionally supported this measure pending NQF-endorsement and
resolution of concerns about the use of two different functional status
scales for quality reporting and payment purposes. Finally, the MAP
reiterated its support for adding measures addressing function, noting
the group's special interest in this PAC/LTC core concept. More
information about the MAP's recommendations for this measure is
available in the report entitled MAP Off-Cycle Deliberations 2015:
Measures under Considerations to Implement Provisions of the IMPACT
Act, is available at https://www.qualityforum.org/Project_Pages/MAP_Post-Acute_CareLong-Term_Care_Workgroup.aspx.
The proposed measure is derived from the Percent of Long-Term Care
Hospital Patients With an Admission and Discharge Functional Assessment
and a Care Plan that Addresses Function quality measure, and we
submitted the proposed measure to NQF for endorsement. The
specifications are available for review at the SNF QRP measures and
technical Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html.
We reviewed the NQF's endorsed measures and were unable to identify
any NQF-endorsed cross-setting quality measures focused on assessment
of function for PAC patients and residents. We are also unaware of any
other cross-setting quality measures for functional assessment that
have been endorsed or adopted by another consensus organization.
Therefore, we proposed to adopt this function measure for use in the
SNF QRP for the FY 2018 payment determination and subsequent years
under the Secretary's authority under section 1899B(e)(2)(B) of the Act
to select non-NQF-endorsed measures as long as due consideration is
given to measures that have been endorsed or adopted by a consensus
organization.
We proposed that data for the proposed quality measure would be
collected through the MDS 3.0, which SNFs currently submit through the
QIES ASAP system. We refer readers to section V.C.7 of this final rule
for more information on the proposed data collection and submission
timeline for this proposed quality measure. The calculation algorithm
of the proposed measure is described in the FY 2016 SNF PPS proposed
rule (80 FR 22075).
For purposes of assessment data collection, we proposed to add new
functional status items to the MDS 3.0. The items would assess specific
self-care and mobility activities, and would be based on functional
items included in the Post-Acute Care Payment Reform Demonstration
version of the CARE Item Set. The items have been developed and tested
for reliability and validity in SNFs, HHAs, IRFs, and LTCHs. More
information pertaining to item testing is available on our Post-Acute
Care Quality Initiatives Web page at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/CARE-Item-Set-and-B-CARE.html.
The proposed function items that we will add to the MDS for
purposes of the calculation of this proposed quality measure do not
duplicate existing items currently collected in that assessment
instrument for other purposes. The currently used MDS function items
evaluate a resident's most dependent episode that occurs three or more
times, whereas the proposed functional items would evaluate an
individual's usual performance at the time of admission and at the time
of discharge. Additionally, there are several key differences between
the existing and new proposed function items that may result in
variation in the resident assessment results including: (1) The data
collection and associated data collection instructions; (2) the rating
scales used to score a resident's level of independence; and (3) the
item definitions. A description of these differences is provided with
the measure specifications on our SNF QRP measures and technical Web
site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html.
Because of the differences between the current function assessment
items (Section G of the MDS 3.0) and the proposed function assessment
items that we would collect for purposes of calculating the proposed
measure, we would require that SNFs submit data on both sets of items.
Data collection for the new proposed function items do not substitute
for the data collection under the current Section G.
We invited public comments on our proposal to adopt beginning with
the FY 2018 SNF QRP an application of the quality measure Percent of
Long-Term Care Hospital Patients with an Admission and Discharge
Functional Assessment and a care Plan that Addresses Function (NQF
#2631; endorsed on July 23, 2015). The following is a summary of the
comments received and our responses.
[[Page 46447]]
Comment: MedPAC did not support the adoption of the function
process measure in the SNF QRP, and urged CMS to adopt outcomes
measures focused on changes in resident physical and cognitive
functioning while under a provider's care.
Response: We appreciate MedPAC's preference for moving toward the
use of functional outcome measures in order to assess the resident's
physical and cognitive functioning under a provider's care. We believe
that the use of this process measure at this time will give us the data
we need to develop a more robust outcome-based quality measure on this
topic in the future. The proposed function quality measure, an
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; endorsed on July 23, 2015), has
attributes to enable outcomes-based evaluation by the provider. Such
attributes include the assessment of functional status at two points in
time, admission and discharge, enabling the provider to identify, in
real time, changes, improvement or decline, as well as maintenance.
Additionally, the proposed quality measure requires that the provider
indicate at least one functional goal associated with a functional
activity, and the provider can calculate the percent of patients who
meet goals. Such real time use enables providers to engage in person-
centered goal setting and the ability to use the data for quality
improvement efforts. In particular, we are currently developing
functional outcome measures, including self-care and mobility quality
measures, for use in the SNF setting. These outcome function quality
measures are intentionally being designed to use the same standardized
functional assessment items that are included in the proposed function
process measure, which will result in a limited additional reporting
burden for SNFs.
Comment: One commenter supported the concept of measuring function
and monitoring the percentage of residents with completed functional
assessments. The commenter was pleased that the quality measure, an
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, endorsed on July 23, 2015), was proposed
for multiple PAC settings in accordance with the IMPACT Act. The
commenter, as well as several other commenters, noted that the proposed
quality measure is an application of the LTCH quality measure, and that
fewer functional assessment items are in the proposed measure when
compared to the LTCH process quality measure, the Percent of Long-Term
Care Hospital Patients with an Admission and Discharge Functional
Assessment and a Care Plan That Addresses Function (NQF #2631, endorsed
on July 23, 2015. For example, one commenter noted that the Confusion
Assessment Method (CAM(copyright)) items and the Bladder
Continence items are not included in the proposed application of the
quality measure.
Response: The proposed functional status process quality measure is
specified as a cross setting quality measure and is standardized across
multiple settings. However, to clarify which specific function items
are included in each function measure for each QRP, we added a table to
the document entitled, SNF QRP: Specifications of Quality Measures
Adopted in the FY 2016 Final Rule, which identifies which functional
assessment items are used in the cross-setting process measure as well
as the setting-specific IRF and LTCH outcome quality measures. The
document is available athttps://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html.
We believe that standardization of assessment items across the
spectrum of post-acute care is an important goal. In this cross-setting
process quality measure, there is a common core subset of function
items that will allow tracking of residents' functional status across
settings. We recognize that there are some differences in residents'
clinical characteristics, including medical acuity, across the LTCH,
SNF and IRF settings, and that certain functional items may be more
relevant for certain patients/residents. Decisions regarding item
selection for each quality measure were based on our review of the
literature, input from a TEP convened by our measure contractor, our
experiences and review of data in each setting from the PAC PRD, and
public comments.
Comment: Several commenters questioned why CARE function items on
the proposed IRF-PAI, MDS 3.0 and LTCH CARE Data Set are not the same
set of items and believed the measure, an Application of The Percent of
Long-Term Care Hospital Patients With an Admission and Discharge
Functional Assessment and a Care Plan That Addresses Function (NQF
#2631; endorsed on July 23, 2015), meant that the items should be the
same set of items.
Response: A core set of mobility and self-care items are proposed
for IRFs, SNFs, and LTCHs, and are nested in the proposed section GG of
the IRF-PAI, MDS 3.0 and LTCH CARE Data Set. Additional function items
are included on the IRF-PAI and LTCH CARE Data Set due to the adoption
of additional outcome-based quality measures in those specific
settings. Therefore, a core set of items in the proposed section GG are
standardized to one another by item and through the use of the
standardized 6-level rating scale. We will work to harmonize the
assessment instructions that better guide the coding of the
assessment(s) as we believe that this will lead to accurate and
reliable data, allowing us to compare the data within each setting.
Comment: Several commenters noted that the proposed function
measure is a process measure and does not capture functional outcomes.
One commenter did not believe that the measure would provide incentives
to improve quality of care given that CMS will not determine if goals
are achieved. The commenters expressed their preference for outcome
measures. One commenter preferred an outcome measure, because they
noted concerns about residents at risk for decline in function. Two
commenters noted that functional outcome measures were under review at
NQF, and two of these quality measures were developed for the SNF
setting. Some of these commenters added that function outcome measures
were proposed for IRFs, but no functional outcomes measures were
proposed for LTCHs or SNFs. One commenter believed that CMS had a
``few'' years to implement the SNF QRP and, thus, has time to develop
outcome measures. One commenter also noted that the name of the
measure, which refers to Long-Term Care Hospital patients, is
misleading. Several commenters expressed concern that the proposed
function process measure does not meet the requirements of the IMPACT
Act because measures must be outcome-based. One commenter stated that
the proposed measure did not satisfy the specified IMPACT Act domain as
the measure is not able to report on changes in function, and one other
commenter claimed that the measure does not satisfy the reporting of
data on functional status. Finally, a commenter stated that the measure
does not have an appropriate numerator, denominator, or exclusions;
lacks NQF endorsement; fails to be based on a common standardized
assessment tool; and lacks evidence that associates the measure with
improved outcomes. One
[[Page 46448]]
commenter claims that because the specifications for the proposed
measure are inconsistent with the measure specifications posted by NQF
for the measure that is under endorsement review, CMS failed to meet
the requirements under the IMPACT Act to provide measure specifications
to the public, and further asserted that one is not able to determine
the specifications that are associated with the proposed measure, which
is an application of the NQF version of the measure.
Response: We agree that the use of outcome measures is important
and, as discussed above, we are currently developing functional outcome
measures for the SNF setting. We appreciate the commenters concern
about monitoring for decline in function and will take that into
consideration as we develop the SNF outcome measures. With regard to
the LTCH QRP, we adopted the quality measure Long-Term Care Hospital
Functional Outcome Measure: Change in Mobility Among Patients Requiring
Ventilator Support (NQF #2632; endorsed on July 23, 2015) in the FY
2015 Final Rule and data collection for this outcome measure begins in
LTCHs on April 1, 2016.
The words ``Long-Term Care Hospital Patients'' are included in the
title of the quality measure because it is an application to the SNF
setting of the existing quality measure, Percent of Long-Term Care
Hospital Patients with an Admission and Discharge Functional Assessment
and a Care Plan that Addresses Function (NQF 2631; endorsed on July 23,
2015), which is a Long-Term Care Hospital quality measure.
We believe that the proposed function measure meets the
requirements of the IMPACT Act. The statute requires, among other
things, the submission of data on the quality measures specified in at
least the domains identified in the Act, but does not require a
particular type of measure (for example, outcome or process) for each
measure domain. Further, as discussed in this section, the measure has
attributes within the assessment and data collection that enables
outcomes-based evaluation by the provider.
We also disagree with the comment that we failed to provide the
specifications to the proposed measure. The proposed function process
quality measure is an application of the measure, the Percent of LTCH
Patients with an Admission and Discharge Functional Assessment and a
Care Plan that Addresses Function (NQF #2631; endorsed on July 23,
2015). The now NQF-endorsed quality measure was proposed and finalized
in the IPPS/LTCH PPS final rule (FR 79 50291 through 50298) for
adoption in the LTCH QRP. An application of this measure was proposed
in the FY 2016 SNF QRP proposed rule, and similarly it was proposed in
the FY 2016 IPPS/LTCH PPS proposed rule and the FY 2016 IRF PPS
proposed rule. We proposed the cross-setting version, an application of
the LTCH QRP quality measure, based on guidance from multiple TEPs
convened by our measure contractor, RTI International. The
specifications for this quality measure, as well as all other proposed
measures for the SNF, LTCH, and IRF QRPs were posted on the CMS Web
site with the posting of the proposed rules to enable public comment.
For the SNF QRP, please see the specifications at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html. These specifications were posted at the
time we issued the proposed rule.
As discussed in the proposed rule under section V.C.5.c., prior to
our consideration to propose this measure's use in the SNF QRP, we
reviewed the NQF's endorsed measures and were unable to identify any
NQF-endorsed, cross-setting or standardized quality measures focused on
assessment of function for PAC patients/residents. We were also unaware
of any other cross setting quality measures for functional assessment
that have been endorsed or adopted by another consensus organization.
Therefore, we proposed a modified version of the quality measure, the
Percent of LTCH Patients with an Admission and Discharge Functional
Assessment and a Care Plan that Addresses Function (NQF #2631; endorsed
on July 23, 2015), with such modifications to allow for its cross-
setting application in the SNF QRP for the FY 2018 payment
determination and subsequent years under the Secretary's authority to
select a non-NQF-endorsed measure. Since the cross-setting measure is
not identical to the measure recommended for NQF-endorsement, it is
considered an application of the measure.
Comment: One commenter suggested that CMS conduct additional
testing of the CARE function items with specific patient/resident
subpopulations. The commenter also suggested research studies that
compare CARE items with other instruments across diverse PAC
populations. They suggested this data be used to improve the CARE items
or replace them with other items to address any potential floor or
ceiling effects. This commenter also suggested studies that compare
models of care for subpopulations so as to elicit best practices
related to complex conditions.
Response: We agree that adoption of the proposed quality measure,
an application to of Percent of Long-Term Care Hospital Patients with
an Admission and Discharge Functional Assessment and a Care Plan that
Addresses Function (NQF 2631; endorsed on July 23, 2015), would offer
many opportunities to examine best practices for caring for SNF
residents. Examining the data for any floor and ceiling effects in
special populations is also a very worthy research idea. With regard to
examining the CARE data against other functional assessment instrument
data, as part of the PAC PRD analyses, we compared data from the
existing items (that is, MDS, OASIS, and the FIM[supreg] instrument)
with data from the analogous CARE items. More specifically, we ran
cross tabulations of MDS function scores and CARE scores for the
patients/residents in the PAC PRD to compare scores. A full description
of the analyses and the results are provided in the report, The
Development and Testing of the Continuity Assessment Record and
Evaluation (CARE) Item Set: Final Report on the Development of the CARE
Item Set and Current Assessment Comparisons Volume 3 of 3, and the
report is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/CARE-Item-Set-and-B-CARE.html. Finally, we agree that ongoing
reliability and validity testing is critical for all items used to
calculate quality measures.
Comment: One commenter recommended revising the definition of the
item ``eating'' as it is a combination of multiple elements of self-
feeding, swallowing ability, and diet texture modification.
Response: The item ``eating'' is classified as an activity, and is
only scored when a resident eats by mouth. The ``eating'' score may
reflect assistance needed due to various impairments such as hand/arm
weakness or coordination issues or swallowing limitations. If a
resident does not eat by mouth and relies on an alternative means of
getting nutrition, ``eating'' is scored as ``activity not attempted.''
Comment: One commenter noted that proposed quality measures, such
as the proposed function quality measure, should reflect several
attributes, including low reporting burden, comprehensibility for
beneficiaries, a
[[Page 46449]]
high level of significance to patients/residents, and data that is
routinely captured.
Response: We believe that this proposed quality measure will have a
high level of significance to residents and providers because it
assesses resident functional status and goals, and that the measure
will not impose a new, significant reporting burden on SNFs because
many already assess these items as part of their standard care
practices. Additionally, the NQF Person- and Family-Centered Care
panel, which included several patient and patient advocates, indicated
by preliminary vote that the measure meets the moderate level of
evidence for ``Use and Usability.'' ``Use and Usability'' refers to
whether the measure is meaningful, understandable, and useful for the
intended audiences for public reporting and quality improvement. These
preliminary results and the description of, ``Use and Usability'' are
described in the report entitled, Phase 2 Draft Report for Voting,
which is available on the Person-and Family-Centered Project Web site
at https://www.qualityforum.org/projects/person_family_centered_care/.
Among the panel, two members voted that the measure met the criteria at
a high level, 12 indicated it met the moderate level of evidence, and
three indicated it was low. With regard to the importance of the
measure to residents, and their families, the measure reviewed by the
Person-and Family-Centered Care panel did meet the importance criteria
with the majority of panel members finding moderate level for evidence,
performance gap and high-priority. These preliminary results and the
description of ``Importance'' are described in the Report entitled,
Phase 2 Draft Report for Voting, which is available on the Person-and
Family-Centered Project Web site at https://www.qualityforum.org/projects/person_family_centered_care/.
Comment: Several commenters indicated they support quality measures
focused on function, but did not support the proposed cross-setting
functional status measure for the SNF QRP. Several commenters noted
their lack of support was due to burden related to reporting functional
status information using two distinct but similar standards and scales,
using different time frames. One commenter noted that section G and
section GG have different measurement metrics, with section GG
providing a more granular look at the components of section G. They
noted that collection of function data using different and conflicting
items presents significant operational challenges and would undermine
the accuracy of data collection. The commenters suggested that the
adoption of the measure would also increase provider confusion because
SNFs would need to be familiar with and apply different rules,
definitions, and metrics when completing resident assessments.
Commenters also suggested that the functional status measure increases
the reporting burden on SNFs but will also lead to inaccurate coding of
resident function for both measurement and payment. In addition, they
noted providers would be required to spend significant time and
resources providing training and oversight to ensure that each data set
is completed accurately and at the right time in the resident's stay.
Commenters also suggested that record keeping and reporting will be
complicated, as electronic medical records will need to be updated to
accommodate dual processes for recording similar clinical information
leading to greater cost to providers and a decrease in the quality and
accuracy of the data collected. Several commenters noted the
significance of adequate training stressing the importance of
appropriate coding of the new items used to calculate the proposed
measures and one commenter specifically asked for clarification on
which health care professional would be responsible for performing the
assessment while another asked that the Minimum Data Set (MDS) Resident
Assessment Instrument (RAI) Manual be provided with the necessary
coding and assessment instructions for the provider's reference in a
timely manner. One commenter suggested transparency with regard to how
CMS will implement the new quality measures and stated that training
for all providers, including instructions for the revised MDS RAI
Manual, would be needed. The commenter suggested open door forums and
training webinars for providers. One commenter specifically asked for
clarification on which health care professional would be responsible
for performing the assessment.
One commenter asked for clarification about the rationale for the
short assessment period for section GG. In addition, a commenter noted
that the coding of section GG, with the current look-back, will make
coding of section G more complex and asked that a streamlined coding
construct that is less complex be adopted. One commenter suggested that
CMS develop a crosswalk to adapt the current items to create the
standardization. One commenter suggested that CMS revise the MDS items
to reduce burden and confusion from the duplication of data, variation
in item definitions, and the variation in the rating scales. One
commenter encouraged CMS to remove items from the existing data sets
where possible. One commenter encouraged CMS to keep the transition
period, during which both section G and section GG would be collected,
short, which would allow for better cross-setting comparisons and
better quality measures, and which is more in line with the intent of
the IMPACT Act. Another commenter cautioned CMS about removing MDS
items that are used for payment, particularly as section G has become a
``payment tool for Medicaid.'' Finally, a commenter suggested that CMS
reach out to vendors to assure validity, timeliness, and accuracy when
MDS changes occur.
Response: We appreciate the commenter's concerns related to the new
requirements that SNFs will have to satisfy to report the proposed
function measure. We agree with the importance of thorough and
comprehensive training and we intend to provide such training in the
near future for all updates to the MDS and assessment requirements. We
also recognize that SNFs might need to conduct training to ensure that
their staffs understand how to properly fill out both section G and
section GG. We also intend to provide comprehensive training as we do
each time the assessment items change.
In addition to the manual and training sessions, we will provide
training materials through the CMS webinars, open door forums, and help
desk support. We welcome ongoing input from stakeholders on key
implementation and training considerations, which can be submitted via
email: PACQualityInitiative@cms.hhs.gov.
We believe that the 6-level scale and additional items in section
GG will allow us to better distinguish change at the highest and lowest
levels of functioning by documenting minimal change from no change at
the low end of the scale.\77\ This is important for measuring progress
in some of the most complex cases treated in PAC. The items in section
GG were developed with input from the clinical therapy communities to
better measure the change in function, regardless of the severity of
the individual's functional limitations.
---------------------------------------------------------------------------
\77\ Barbara Gage et al., ``The Development and Testing of the
Continuity Assessment Record and Evaluation (CARE) Item Set: Final
Report on the Development of the CARE Item Set'' (RTI International,
2012).
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[[Page 46450]]
To reduce the potential burden associated with collecting
additional items, we have included several mechanisms in the section GG
to reduce the number of items that apply to any one resident. First, in
section GG, there are gateway questions pertaining to walking and
wheelchair mobility that allow the clinician to skip items that ask if
the resident does not walk or does not use a wheelchair, respectively.
For example, in section GG, there is an item that asks whether or not
the resident walks. If the resident does not walk, three items in
section GG related to walking ability are skipped. Second, section GG
items will only be collected at admission and discharge. The gateway
questions and skip patterns mean that only a subset of section GG items
are needed for most residents. However, by including all of them in the
form, the standardized versions are available when appropriate for an
individual resident. With regard to the assessment time frames, for the
MDS items located in section G, the assessment time frames take into
consideration all episodes of the activity that occur over a 24-hour
period during each day of the 7-day assessment period, as a resident's
ADL self-performance and the support required may vary from day to day,
shift to shift, or within shifts. As stated in the CMS MDS 3.0 Resident
Assessment Instrument manual, ``the responsibility of the person
completing the assessment, therefore, is to capture the total picture
of the resident's ADL self-performance over the 7-day period, 24 hours
a day (that is, not only how the evaluating clinician sees the
resident, but how the resident performs on other shifts as well)''
(CMS, 2014, ch. 3, p. G-4). The CARE function items in the proposed
functional quality measures, to be nested in the proposed Section GG,
have a shorter assessment time frame (3 calendar days), which is
standardized across the PAC settings, based on the need for data
reflecting the resident's status at the time of admission and
discharge. For admission, the CARE function items are to reflect the
status of the person as the person is admitted to the SNF; in other
words, self-care and mobility limitations present at the time of
admission. We recognize that when residents are first admitted to a
SNF, clinicians often determine the resident's clinical status based on
several observations and often after a period of time in which the
resident adjusts to the new environment. We also recognize that several
clinicians from different disciplines are observing the resident's
status and this may not occur on the day of admission. Further, we are
aware that residents who receive rehabilitation services may have
improvement in function soon after admission to the SNF as therapy
services may be provided on the day of admission or the next day. If
the admission assessment is not completed early in the stay, the
admission score may reflect improvement already achieved by the
resident due to treatment provided. In other words, functional
improvement would not be reflected in function scores if the admission
assessment is conducted after therapy has started and impacted the
resident's status or before therapy ends. Therefore, clinicians report
resident's admission functional assessment for the CARE items based on
3 calendar days. This assessment time frame has been used in IRFs
successfully and balances the need for data reflecting the resident's
status at the time of admission and the interest in documenting changes
in function between admission and discharge.
Finally, we thank the commenters for their comments pertaining to
electronic medical records (EMRs). While we applaud the use of EMRs,
CMS does not require that providers use EMRs to populate assessment
data. It should be noted that with each assessment release, we provide
free software to our providers that allows for the completion and
submission of any required assessment data. The use of a vendor to
design software that extracts data from a provider's EMR to populate
CMS quality assessments, is a business decision that is made solely by
the provider. We only require that assessment data be submitted via the
QIES ASAP system in a specific compatible format. Providers can choose
to use our free software, or the data submission specifications we
provide that allow providers and their vendors to develop their own
software, while ensuring compatibility with the QIES ASAP system.
Comment: Several commenters noted that the items included in the
Section GG of the MDS differ from those tested during the PAC PRD and
represented a limited set of items from the original CARE Tool. One of
these commenter suggested that the contributions of occupational
therapy may not be measureable with the limited set of items. Another
commenter suggested that the assessment time frame differed from that
used in the PAC PRD.
Response: The PAC PRD tested a range of items, some of which were
duplicative, to identify the best performing items in each domain.
Select items were removed from the item set where testing results and
clinician feedback suggested the need for fewer items to be included in
a particular scale. We also received feedback on the items tested in
the PAC PRD from a cross-setting TEP convened by our measure
development contractor, RTI International. Other changes from the
original PAC-PRD items included incorporating instructional detail from
the manual and training materials directly into the data collection
form and updating skip patterns to minimize burden. We agree that the
contribution of occupational therapy as well as other clinical
disciplines, should be reflected in all item and measure development.
During the PAC-PRD, clinicians from many different disciplines
collected CARE data, including occupational therapists (OTs). In
addition, the items in section GG were developed with the input from
clinicians would be performing the assessments, including OTs.
With regard to the assessment time frame for the CARE function
items, we instructed clinicians to use a 2-day time frame if the
patients/residents were admitted before 12 p.m. (noon) or 3 calendar
days if the patients/residents were admitted after 12 p.m. Our exit
interviews revealed that most patients/residents were admitted to the
SNF after 12 p.m. and that clinicians used 3 calendar days. Therefore,
we have used the assessment time frame that most clinicians used during
the PAC-PRD.
Comment: One commenter expressed concern about the reliability
testing results for licensed nurses in the PAC PRD, given that licensed
nurses play a large role in documenting function.
Response: The reliability results mentioned by this commenter were
only one of several reliability analyses conducted to support the
development of this measure as part of the PAC PRD. The results of
licensed nurses reflect the small sample. In addition to the inter-
rater reliability study mentioned by these commenters, we also
examined: (1) Inter-rater reliability of the CARE items using
videotaped case studies, which included 550 assessments from 28
providers; and (2) internal consistency of the function data, which
included more than 2,749 SNF residents. Overall, these results indicate
moderate to substantial agreement on these items. The report describing
these additional analyses and an interpretation of the Kappa statistics
results is available at https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-
Initiatives/Downloads/The-Development-and-Testing-of-the-
[[Page 46451]]
Continuity-Assessment-Record-and-Evaluation-CARE-Item-Set-Final-
Reporton-Reliability-Testing-Volume-2-of-3.pdf.
Therefore, given the overall findings of these reliability
analyses, we believe that the proposed function measure is sufficiently
reliable for the SNF QRP.
Comment: One commenter was concerned that no data was provided
clearly linking improved outcomes to this process measure.
Response: We believe that there is evidence that this is a best
practice based on several clinical practice guidelines. The NQF
requirement for endorsing process measures is that the process should
be evidence-based, such as processes that are recommended in clinical
practice guidelines. As part of the NQF process, CMS submitted several
such clinical practice guidelines 78 79 80 to support this
measure, and referenced another cross-cutting clinical practice
guideline in the proposed rule. The clinical practice guideline
Assessment of Physical Function \81\ recommends that clinicians should
document functional status at baseline and over time to validate
capacity, decline, or progress. Therefore, assessment of functional
status at admission and discharge and establishing a functional goal
for discharge as part of the care plan (that is, treatment plan) is an
important aspect of patient/resident care for all of these PAC
providers.
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\78\ Kresevic DM. Assessment of physical function. In: Boltz M.,
Capezuti E., Fulmer T., Zwicker D., editor(s). Evidence-based
geriatric nursing protocols for best practice. 4th ed. New York
(NY): Springer Publishing Company; 2012. p. 89-103. Retrieved from
https://www.guideline.gov/content.aspx?id=43918.
\79\ Centre for Clinical Practice at NICE (UK). (2009).
Rehabilitation after critical illness (NICE Clinical Guidelines No.
83). Retrieved from https://www.nice.org.uk/guidance/CG83.
\80\ Balas M.C., Casey C.M., Happ M.B. Comprehensive assessment
and management of the critically ill. In: Boltz M., Capezuti E.,
Fulmer T., Zwicker D., editor(s). Evidence-based geriatric nursing
protocols for best practice. 4th ed. New York (NY): Springer
Publishing Company; 2012. p. 600-27. Retrieved from https://www.guideline.gov/content.aspx?id=43919.
\81\ Kresevic DM. Assessment of physical function. In: Boltz M.,
Capezuti E., Fulmer T., Zwicker D., editor(s). Evidence-based
geriatric nursing protocols for best practice. 4th ed. New York
(NY): Springer Publishing Company; 2012. p. 89-103. Retrieved from
https://www.guideline.gov/content.aspx?id=43918.
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Comment: Several commenters suggested that CMS develop a plan to
revise the existing MDS function items to be more consistent with the
data collected in the other PAC settings, noting this would lay the
groundwork for a measure that is more ``standardized'' and
``interoperable'' across post-acute care settings. Some commenters
noted that this transition would require considerable analysis to
ensure there are not negative unintended consequences for SNF
reimbursement, and testing in SNF facilities to ensure the revised
instrument collects accurate, reliable and meaningful data.
Response: We have proposed to add a core set of CARE function items
to the MDS for SNFs, the IRF-PAI for IRFs and the LTCH CARE Data Set.
These standardized data will enable interoperability across these PAC
settings. As noted above, the proposed IRF-PAI and proposed LTCH CARE
Data Set include additional CARE function items, because those QRPs
include additional functional outcome measures, and these measures
require collection of more than just the core items included in the
function process measure. The development of the entire original set of
CARE function items, including the definitions for each activity, were
selected based on a review of all existing items used by LTCHs, IRFs,
SNFs and HHAs, a review of the literature, and input from stakeholders
such as clinicians and researchers.
Comment: One commenter noted that the proposed function measure
includes reporting of a goal as a way to document that residents have a
care plan that addresses function, and that this reporting of function
goals was not part of the original PAC PRD. The commenter further noted
that reporting of only one goal was not ideal, because many residents
have goals for multiple functional activities and the number of
standardized functional assessment items is limited compared to the
full set of function items tested as part of the PAC PRD. Finally, the
commenter indicated that treatment goals may be to improve function,
and therefore, are restorative in nature, while therapy may be
necessary so to ensure the maintenance of a PAC resident's function.
Response: The proposed function measure requires a minimum of one
(1) goal per resident stay; however, clinicians can report goals for
each self-care and mobility item included in the proposed section GG of
the MDS. We believe that assessing resident function goals should be
part of clinical care and builds upon the conditions of participation
(CoPs) for SNF providers. The IMPACT Act also specifically mentions
goals of care as an important aspect of the use of standardized
assessment data, quality measures, and resource use to inform discharge
planning and incorporate resident preference. We agree that for many
PAC patients/residents, the goal of therapy is to improve function and
we also recognize that for some residents, delaying decline may be the
goal. We believe that individual, person-centered goals exist in
relation to individual preferences and needs. We will provide
instructions pertaining to the reporting of goals in a training manual
and in training sessions in order to better clarify that goals set at
admission may be focused on improvement of function or maintenance of
function.
Comment: Several commenters were concerned that the measure, an
Application of the Percent of Long-Term Care Hospital Patients with an
Admission and Discharge Functional Assessment and a Care Plan That
Addresses Function (NQF #2631;endorsed on July 23, 2015) was not NQF
endorsed. Some of these commenters noted that it was under review at
NQF for the LTCH setting and not for the SNF setting.
Response: We agree that the NQF endorsement process is an important
part of measure development. We have proposed an application of the
quality measure, the Percent of Long-Term Care Hospital Patients with
an Admission and Discharge Functional Assessment and a Care Plan That
Addresses Function. This quality measure is now NQF endorsed. We have a
rigorous process of construct testing and measure selection, guided by
the TEPs, public comments from stakeholders, and recommendations by the
PAC/LTC MAPs.
Comment: One commenter recognized the burden of changing assessment
items, but noted the utilization of standardized assessment items is
expected to improve transitions. The commenter indicated that proposal
was an action of good intent toward the statutory standardization of
assessment.
Response: We thank the commenter for their comment and support for
the inclusion of the standardized (that is, CARE) functional assessment
items. We agree that standardized assessment across PAC settings has
the potential to improve care.
Comment: One commenter noted that one reason for standardized
assessment items ``would be to establish a common language for patient
and resident functioning, which may facilitate communication and care
coordination as patients and residents transition from one type of
provider to another,'' and asked CMS to provide data on the number or
percent of patients/residents that transition from one type of provider
to another. The commenter further requested information about why the
[[Page 46452]]
current measures fail to provide clinicians with the information
needed.
Response: Several studies have documented patient/resident
transition patterns following discharge from the hospital and
continuing for 30, 60, or 90 days.82 83 84 While the exact
proportions discharging to each type of care vary slightly across the
years, the proportion of acute hospital admissions being discharged to
PAC has grown from 35 percent in 2006 to 43 percent in more recent
years (MedPAC, 2014). Among those discharged to PAC, the majority are
discharged to SNF or HHA, and a much smaller proportion are discharged
to IRFs and LTCHs. Further examination shows that among each of the
four PAC admissions, many individuals continue to transition to
subsequent sites of care. Common discharge patterns from the IRF, for
example, include over 75 percent of cases continuing into HHA or
outpatient therapy services. SNF cases are commonly discharged home
with either outpatient therapy or home health services. One report
outlining these issues is entitled, ``Examining Post Acute Care
Relationships in an Integrated Hospital System'' (available at https://aspe.hhs.gov/health/reports/09/pacihs/report.pdf). This report includes
a summary of the most common PAC transition patterns for Medicare FFS
Beneficiaries in 2006.
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\82\ Gage, B., Morley, M., Ingber, M., & Smith, L. (2011). Post-
Acute Care Episodes Expanded Analytic File: RTI International.
Prepared for the Assistant Secretary for Planning and Evaluation.
Retrieved from https://aspe.hhs.gov/health/reports/09/pacihs/report.pdf.
\83\ Gage, B., Morley, M., Constantine, R., Spain, P., Allpress,
J., Garrity, M., & Ingber, M. (2008). Examining Relationships in an
Integrated Hospital System: RTI International. Prepared for the
Assistant Secretary for Planning and Evaluation. Retrieved from
https://aspe.hhs.gov/health/reports/08/examine/report.html.
\84\ Gage, B., Pilkauskas, N., Dalton, K., Constantine, R.,
Leung, M., Hoover, S., & Green, J. (2007). Long-Term Care Hospital
(LTCH) Payment System Monitoring and Evaluation Phase II Report RTI
International. Prepared for the Centers for Medicare & Medicaid
Services. Retrieved from https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/LongTermCareHospitalPPS/downloads/rti_ltchpps_final_rpt.pdf.
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Comment: One commenter encouraged CMS to risk adjust all outcome
measures.
Response: The proposed function quality measure, an Application of
the Percent of Long-Term Care Hospital Patients with an Admission and
Discharge Functional Assessment and a Care Plan that Addresses Function
(NQF #2631, endorsed on July 23, 2015), is a process measure that
focuses on the clinical process of completion of functional assessments
and a care plan addressing function. Although the IMPACT Act requires
that the cross-setting quality measures be risk-adjusted as determined
appropriate by the Secretary, it does not limit the Secretary to
adopting outcome measures. Some process measures are risk
adjusted,85 86 However, in the development of an application
of the measure, the Percent of LTCH Patients with an Admission and
Discharge Functional Assessment and a Care Plan that Addresses Function
(NQF #2631; endorsed on July 23, 2015), the Technical Expert Panel
considered, but did not recommend, the application of a risk adjustment
model. We agree with that conclusion because the completion of a
functional assessment, which includes the use of ``activity not
attempted'' codes, is not affected by the medical and functional
complexity of the resident. Therefore, we believe that risk adjustment
of this quality measure is not warranted.
---------------------------------------------------------------------------
\85\ For example, in the NQF-endorsed process measure Percent of
Residents Who Have/Had a Catheter Inserted and Left in Their Bladder
(long stay) (NQF#0686) for which we are the steward, resident-level
limited covariates (Frequent bowel incontinence, or always
incontinent on prior assessment; and Pressure ulcers at stages II,
III, or IV on prior assessment) are used in a logistic regression
model to calculate a resident-level expected quality measure score.
\86\Peter C. Smith, Elias Mossialos, Irene Papanicolas and
Sheila Leatherman. Performance Measurement for Health.
---------------------------------------------------------------------------
Comment: Several commenters noted additional areas of function that
are key to residents, including cognition, communication, and
swallowing. One commenter encouraged CMS to consider cognition and
expressive and receptive language and swallowing as items of function
and not exclusively as risk adjustors, and offered their expertise to
CMS for discussions and to develop goals. Another commenter examined
the SNF, IRF, HHA and LTCH assessment instruments and noted that
cognitive function is measured differently across the settings in terms
of content, scoring process, and intended calibration of each tool, and
encouraged CMS to align items and quality measurement of cognition.
Response: We are working toward developing quality measures that
assess areas of cognition and expression, recognizing that these
quality topic domains are intrinsically linked or associated to the
domain of function and cognitive function. We appreciate the
commenter's offer for assistance and encourage the submission of
comments and measure specification details to our comment email:
PACQualityInitiative@cms.hhs.gov.
Comment: One commenter suggested that CMS remove some items from
section G if section GG items are adopted. One commenter noted that the
four late-loss activities of daily living (ADL) items from Section G
should be retained and this commenter recognized that some items were
needed for payment. The commenter noted differences in the rating
scales for the items in section G and the items in section GG.
Response: We recognize that the items in section G serve many
purposes such as those items that are used for payment, and will
continue to take into consideration all factors pertaining to payment
and quality.
Comment: One commenter was concerned that residents with missing
data in their assessment records would be excluded from this measure.
This commenter was concerned that this could present SNFs with an
opportunity to purposefully exclude data.
Response: We thank the commenter for their comments and appreciate
the concerns pertaining to intentionally excluded data. We would like
to clarify that there are no resident exclusions criteria for this
measure. Therefore, this potential for ``gaming'' does not exist for
this measure. Nonetheless, as part of our compliance analysis we intend
to carefully monitor rates of missing data across all facilities.
Specifically, we are finalizing that for FY 2018, any SNF that does not
meet the proposed requirement that 80 percent of all MDS assessments
submitted contain 100 percent of all data items necessary to calculate
the SNF QRP measures would be subject to a reduction of two percentage
points to its FY 2018 market basket percentage. We hope this
requirement will incentivize providers to submit complete MDS 3.0
assessments.
Comment: A commenter was concerned about the use of a consistent
definition of the short-stay population, the denominator, in this
function measure, as well as the other proposed measures for use in the
SNF QRP. The commenter was also concerned about the alignment of
measures with major CMS initiatives.
Response: We appreciate the commenters' comments pertaining to the
differences in the function quality measure denominators by payer type
across the IRF, SNF and LTCH settings and we have addressed this
comment previously. We believe that quality care is best represented
through the inclusion of all patient data regardless of payer source.
We agree that consistency in the data would reduce confusion in data
interpretation and enable a more comprehensive evaluation of quality
and although we had not proposed all payer data collection through this
current rulemaking, we will take into
[[Page 46453]]
consideration the expansion of the SNF QRP to include all payer sources
through future rulemaking.
Comment: Two commenters requested that CMS continue in its public
engagement with stakeholders, and one requested increased engagement
with regard to the IMPACT Act and measures it considers. Other
commenters stated their appreciation for inclusion and opportunity to
work with CMS during the implementation phases of the IMPACT Act. One
commenter also recommended that CMS establish a more formal stakeholder
group to include rehabilitation professionals who can provide expertise
on the provision of rehabilitation therapy in NFs. This commenter noted
that the more opportunities stakeholders have to engage in dialogue
with and advise CMS on the quality measures, the greater the
possibility that the measures will be accurate and helpful to
determining care quality.
Response: We appreciate the continued involvement of stakeholders
in all phases of measure development and implementation, as we see the
value in strong public-private partnerships. We also believe that
ongoing stakeholder input is important to the success of the IMPACT Act
and look forward to continued and regular input from the provider
communities as we continue to implement the IMPACT Act.
Comment: One commenter suggested that the PAC PRD data was
collected only by therapists, and expressed concern that the items had
not been tested using other care providers. In addition, this commenter
had specific questions about scoring different assessments during the
time window proposed. This commenter also had specific questions about
which SNF clinicians will complete the functional assessment items for
this measure.
Response: We wish to clarify that during the PAC PRD, data were
collected by clinicians from many different disciplines, including OTs,
PTs, SLPs and RNs. Reliability testing included testing by discipline
as well as by setting. However, the items were developed with the input
of various personnel who would be performing the assessments, which
included OTs, PTs, SLPs, and RNs. Regarding the questions about scoring
assessments and staff that will be trained to complete functional
assessments, we have historically provided training for providers. As
we prepare for this type of training, we will make sure to have this
type of information available to the public to increase transparency
and readiness.
Comment: A commenter urged CMS to develop function measures that
take resident quality of life into account. The commenter noted that
function measures are not ``one size fits all.'' Another commenter
suggested CMS focus on key concerns of beneficiaries with disabilities
and chronic conditions, including, where appropriate: The ability to
live as independently as possible, to function at the maximum extent
possible, to return to employment where appropriate, to engage in
recreational and athletic pursuits, to engage in community activities,
and to maintain the highest quality of life possible.
Response: We believe that this proposed quality measure will have a
high level of significance to residents and providers. The proposed
function quality measure is a person and family-centered process
measure that reports standardized functional assessment data at
admission and discharge, as well as at least one functional status
discharge goal, demonstrating person and family-centered care. The
IMPACT Act specifically mentions goals of care as an important aspect
of the use of standardized assessment data, quality measures, and
resource use to inform discharge planning and incorporate resident
preference. However, we are always open to stakeholder feedback on
measure development and encourage everyone to submit comments to our
comment email: PACQualityInitiative@cms.hhs.gov.
Comment: One commenter recommended that CMS exclude section GG data
from all medical review organizations or processes for the first three
years.
Response: The item sets included in section GG are being proposed
to satisfy measure domains under the IMPACT Act and are not being
proposed for use in making payment determinations. The primary purpose
of medical review is to validate medical necessity and to identify
coding discrepancies to determine whether payment is appropriate. The
item sets in Section GG are not being used for this purpose and are
therefore not subject to medical review. A provider's failure to submit
the data to complete section GG could result in a determination of
noncompliance with the SNF QRP, resulting in a 2 percent reduction to
the SNF's market basked percentage for the applicable fiscal year.
Final Decision: Having carefully considered the comments we
received on the application of the Percent of LTCH Patients with an
Admission and Discharge Functional Assessment and a Care Plan that
Addresses Function (NQF #2631; endorsed on July 23, 2015), we are
finalizing the adoption of this measure for use in the SNF QRP.
f. SNF QRP Quality Measures Under Consideration for Future Years
Table 10--SNF QRP Quality Measures and Concepts Under Consideration for
Future Years
------------------------------------------------------------------------
------------------------------------------------------------------------
IMPACT Act Domain................. Measures to reflect all-condition
risk-adjusted potentially
preventable hospital readmission
rates.
Measures.......................... (NQF #2510): Skilled Nursing
Facility 30-Day All-Cause
Readmission Measure (SNFRM).
(NQF #2512; NQF #2502): Application
of the LTCH/IRF All-Cause Unplanned
Readmission Measure for 30 Days
Post Discharge from LTCHs/IRFs.
IMPACT Act Domain................. Resource Use, including total
estimated Medicare spending per
beneficiary.
Measure........................... (NQF #2158): Application of the
Payment Standardized Medicare
Spending Per Beneficiary (MSPB).
IMPACT Act Domain................. Discharge to community.
Measure........................... Percentage residents/patients at
discharge assessment, who are
discharged to a higher level of
care or to the community. Measure
assesses if the patient/resident
went to the community and whether
they stayed there. Ideally, this
measure would be paired with the 30-
day all-cause readmission measure.
------------------------------------------------------------------------
We invited comments on the measure domains and associated measures
and measure concepts listed in Table 10. In addition, consistent with
the requirements of the IMPACT Act to develop quality measures and
standardize data for comparative purposes, we believe that evaluating
outcomes across the post-acute care settings using standardized data is
an important priority. Therefore, in addition to adopting a process-
based measure for the IMPACT Act domain of ``Functional status,
cognitive function, and changes in function and cognitive function'',
which is included in this year's final rule, we also intend to develop
outcomes-based quality
[[Page 46454]]
measures, including functional status and other quality outcome
measures to further satisfy this domain. These measures will be
proposed in future rulemaking in order to assess functional change for
each care setting as well as across care settings. The comments we
received on this topic, with their responses, appear below.
Comment: Several commenters urged CMS to consider future quality
measures for the SNF QRP related to various topics including: Patient
and family engagement; nutrition; key concerns related to a patient's
quality of life following discharge from post-acute care; and
workforce. One commenter requested that quality measures currently
reported through Nursing Home Compare also be considered for future use
in the SNF QRP.
Response: We agree that the suggested measure areas are important
for quality of care in SNFs, and we would like to highlight that
measures pertaining to nutrition, quality of life, patient and family
engagement and person-centered care are known gaps in quality, and
therefore, are among our priorities to address. Such measures align
with our CMS Quality Strategy. We also agree with the importance of
workforce related measures as we understand that quality outcomes are
often directly linked with staffing and workforce. We agree that
measures currently reported through Nursing Home Compare should also be
considered for future use in the SNF QRP, and we are finalizing two
measures currently reported through Nursing Home Compare (Percent of
Residents or Patients with Pressure Ulcers that are New or Worsened
(Short Stay) (NQF #0678) and an application of the measure Percent of
Residents Experiencing One or More Falls with Major Injury (Long Stay)
(NQF #0674)) for the FY 2018 SNF QRP. We will consider the commenters'
recommendations in our measure development and testing efforts, as well
as in our ongoing efforts to identify and propose appropriate measures
for the SNF QRP in the future.
Comment: One commenter supported the IMPACT Act requirement to
measure and report on rehospitalization and discharge to community
measures. However, the commenter expressed several concerns regarding
the potential future measures identified by CMS and recommended several
considerations for future measure development. The commenter did not
believe that three potential future rehospitalization measures (Skilled
Nursing Facility 30-Day All-Cause Readmission Measure (NQF #2510),
Application of the LTCH/IRF All-Cause Unplanned Readmission Measure for
30 Days Post Discharge from LTCHs/IRFs (NQF #2512; NQF #2502)) comply
with IMPACT Act requirements because the measures have different
numerator and denominator definitions and exclusions. The commenter is
also concerned that while the three measures are NQF-endorsed in each
of their respective settings, they are not yet endorsed as cross-
setting measures. Finally, the commenter states that these measures
should not be restricted to Medicare FFS beneficiaries as this is
inconsistent with the IMPACT Act. To comply with the IMPACT Act
requirements, this commenter recommended that CMS develop an all-cause
all payer rehospitalization measure that (a) is not restricted to
Medicare FFS beneficiaries, and (b) has the same numerator and
denominator definitions, but may use different risk adjustment
variables, in each PAC setting. The commenter further suggests that
pairing the proposed rehospitalization measure with the discharge to
community measure would not be appropriate.
When developing the Discharge to Community measure, the commenter
recommends that CMS consider differences across PAC providers, and the
implications of those differences on measure specification. An
additional commenter also supported the Discharge to Community measure,
which is under consideration for future years.
The commenter also recommended that when developing a resource
measure, CMS should collect information from NQF on prior work done to
address challenges related to developing a reliable and valid resource
measure that measures total Medicare spending per beneficiary. Finally,
the commenter stated that CMS needs to begin working on a medication
reconciliation measure as listed in the IMPACT Act.
Response: We believe that we have the discretion to implement
either a within stay readmission measure, or a post-PAC discharge
readmission measure in satisfaction of the IMPACT Act. Therefore, both
measure concepts listed could be applicable. We appreciate the
suggestion that such a measure not be paired with the discharge to
community measure and will take this under consideration. With regard
to the suggested development of an all-cause all payer
rehospitalization measure that is not restricted to Medicare FFS
beneficiaries, has uniform numerators and denominators and is
appropriately risk adjusted in each PAC setting, we appreciate the
commenter's suggestions and generally agree to the importance of all
payer data. That said, consistent with the other PAC settings' post-
discharge hospital readmission measures, such a cross-setting measure
for this setting is currently under development as a claims based
measure thereby limiting its denominator to Medicare claims data and we
intend to standardize denominator and numerator definitions. With
regard to NQF endorsement as a cross-setting measure, as mentioned
previously, when possible we will propose and adopt a measure that has
been endorsed by the NQF. However, when this is not feasible, the
IMPACT Act in section 1899B(e)(2)(B), permits the Secretary to adopt a
measure for the QRPs that is not NQF-endorsed. We want to clarify that
the IMPACT Act does allow for program-related risk adjustment, as
appropriate, and we intend to risk adjust the readmission measure
intended to satisfy the IMPACT Act domain, which is an all-condition
risk-adjusted potentially preventable hospital readmission rate. We
appreciate the commenter's concern that CMS ensure the development of a
medication reconciliation measure and although the Medication
Reconciliation domain of the IMPACT Act was not addressed in this
year's SNF proposed rule, we are currently in the process of developing
a cross-setting measure to address this domain of care.
Comment: One commenter made several suggestions regarding the
process CMS should use when developing future measures. The commenter
recommended that CMS seek additional stakeholder input as it develops
more detailed specifications for the measures under consideration for
future years and that CMS seek NQF endorsement for future measures
prior to including them in rulemaking.
Response: We will take the recommendations into consideration in
our measure development and testing efforts, as well as in our ongoing
efforts to identify and propose appropriate measures for the SNF QRP in
the future. We recognize the need for transparency as we move forward
to implement the provisions of the IMPACT Act and plan to continue to
engage stakeholders to ensure that our approach to implementation is
communicated in an open and informative manner.
Comment: Two commenters requested that CMS consider the CARE-C and
CARE-F items based on the National Outcomes Measurement System (NOMS)
to capture communication, cognition, and swallowing as additional
measures to be adopted in post-acute care settings for future measures.
One commenter encourages CMS and other measure developers to consider
[[Page 46455]]
functional items such as velocity or gait speed which may provide a
more meaningful picture of the quality of mobility performance versus
ambulation distance.
Response: We note that comments on the addition of areas of
function, including cognition, communication, and swallowing are
addressed further in section III.D.3.e. iii., Quality Measure
Addressing the Domain of Functional Status, Cognitive Function, and
Changes in Function and Cognitive Function: 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; endorsed on July 23, 2015). We appreciate the suggestion that we
consider functional items such as velocity or gait speed which may
provide a more meaningful picture of the quality of mobility
performance versus ambulation distance. We will consider these
recommendations in our item and measure development and testing efforts
for both measure development as well as standardized assessment domain
development.
g. Form, Manner, and Timing of Quality Data Submission
(1) Participation/Timing for New SNFs
Beginning with the submission of data required for the FY 2018
payment determination, we proposed that a new SNF would be required to
begin reporting data on any quality measures finalized for that program
year by 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. For example, for FY 2018 payment determinations,
if a SNF received its CCN on August 28, 2016, and 30 days are added
(for example, August 28 + 30 days = September 27), the SNF would be
required to submit data for residents who are admitted beginning on
October 1, 2016.
We invited public comments on this proposed timing for new SNFs to
begin reporting quality data under the SNF QRP. However we received no
comments on this proposal.
Final Decision: We are finalizing our proposal pertaining to the
Participation/Timing for New SNFs as proposed.
(2) Data Collection Timelines and Requirements for the FY 2018 Payment
Determination and Subsequent Years
As discussed previously, we proposed that SNFs would submit data on
the proposed functional status, skin integrity, and incidence of major
falls measures by completing items on the MDS and then submitting the
MDS to CMS through the Quality Improvement and Evaluation System
(QIES), Assessment Submission and Processing System (ASAP) system. We
sought comment on the proposed method of data collection.
We received no comments on the use of the MDS as the proposed
method for data collection and the QIES ASAP system for data
submission. Therefore, we are finalizing this approach as proposed.
Currently, there is no discharge assessment required when a
resident is discharged from the SNF Medicare Part A covered stay but
does not leave the facility, and we are aware that this affects nearly
30 percent of all SNF residents. To collect the data at the time these
beneficiaries are discharged from the SNF Part A covered stay, we
proposed to add an item set in addition to the 5-Day PPS Assessment.
Further, to collect the data elements required to calculate the
function quality measure (an 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; endorsed on July
23, 2015]) at the time of a residents admission, we also proposed to
add the necessary items to the 5-day PPS Assessment.
A list of the data items that we are proposed to add to the SNF PPS
Part A Discharge and the 5-Day PPS Assessments is available on our Web
site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html. We recognize that
there may be instances where SNFs want to combine the SNF PPS Part A
Discharge Assessment with other required assessments, as happens with
other PPS and OBRA assessments, or scenarios in which the end of the
Part A covered stay occurs at the same time as a scheduled PPS
assessment. Therefore, we invited public comment on any situations
where assessments may be combined or interact, which should be
considered in implementing the SNF PPS Part A Discharge Assessment with
a view toward addressing any issues that we may identify through the
public comment process as requiring additional clarification.
We invited public comments on our proposed SNF QRP Data Collection
Requirements for the FY 2018 Payment Determination and Subsequent
Years.
Comment: One commenter recommended that CMS shorten the MDS
discharge assessment to only information needed to construct the
measures since the information will not be used in patient care,
suggesting that its use pertained to the IMPACT Act requirements for
collecting information at admission and discharge for measurement
purposes. The commenter also recommended that the OBRA Admission
assessment should be completed as a dually coded assessment with the
PPS 5-day assessments in order that admission assessments for measures
are aligned for all Medicare and Non-Medicare beneficiaries, such as
Medicare Advantage beneficiaries.
Response: The discharge assessment is intended to collect the
standardized data used to calculate the measures. Therefore, the SNF
PPS Part A Discharge includes only the discharge assessment data needed
to inform current and future SNF QRP measures and the calculation of
those measures. With regard to the commenter's recommendation that the
OBRA Admission assessment be dually coded with the 5-day assessment, we
note that this type of combination is possible under the current
system, though not required.
Comment: Several commenters suggested that the MDS was designed as
an assessment for adults and does not address the needs of individuals
under 21 years of age, specifically children with complex medical needs
like an intellectual or developmental disability. Though NFs that treat
pediatric residents complete the MDS for those residents, it is not an
appropriate tool to measure resident needs or to use as the basis of a
comprehensive care plan for pediatric residents. Thus, the commenter
requested that pediatric NFs be exempted from completing the MDS for
their residents, and that data from the MDS not be utilized for the
quality measures of pediatric NFs, or that CMS adopt an assessment
instrument for pediatric SNFs that reflect the unique areas of focus.
In addition, one commenter suggests that residents of a sub-acute
SNF unit are at elevated risk for medical complications due to their
chronic, long-term, acute illnesses, when compared to residents of
other SNF units. Due to the differences between residents of sub-acute
SNF units and ``regular'' SNFs, the commenter requests that an
additional field be added to the MDS to identify sub-acute SNF
residents.
Response: The MDS was designed with numerous groups in mind,
including pediatric nursing home
[[Page 46456]]
residents and their caregivers. In addition, data submission to CMS for
the purposes of the SNF QRP requires the submission of such data while
the resident is under a Part A covered stay. Regarding the comment on
sub-acute units, we will take the recommendation into consideration.
Comment: One commenter expressed concerns about the accuracy of the
MDS data that will be used to calculate the new quality measures. The
commenter noted that the MDS 3.0 Focused Survey Pilot conducted by CMS
found ``room for improvement in MDS 3.0 assessment agreement with a
resident's medical record, especially in the reporting of the severity
and frequency of falls, late loss ADL status, pressure ulcer status,
restraint use, and coding of certain diagnoses including UTI.'' The
commenter suggested that additional steps are necessary to improve data
accuracy, such as revising and testing revisions to the survey
protocol, drafting additional guidance and requiring additional
training for surveyors, conducting special surveys of resident
assessments, reporting on Nursing Home Compare when data are invalid,
and promulgating regulations to require penalties for violations of
assessment requirements.
Response: We agree that training is critical to assure both
provider accuracy and understanding of the assessment and data
collection requirements. We appreciate the commenter's suggestions
pertaining to use of various means to ensure accuracy, such as
surveyor-related protocols and activities as well as the use of Nursing
Home Compare for the reporting of data and will take these into
consideration. We discuss below our intention to develop a data
validation program to ensure that SNF QRP data is accurately reported.
Comment: One commenter expressed that it is unclear about the
timeframe in which additional items will be added to the MDS item sets.
The commenter recommended that CMS standardize and align the PAC
assessments (MDS, OASIS, IRF-PAI, and LTCH-CARE) prior to finalizing
the proposed quality measures. The commenter suggested that after the
PAC assessments are aligned, CMS should utilize a period of testing for
the proposed measures. The commenter also suggested that the quarterly
reporting of claims data requires that hospital claims and PAC provider
claims be tracked simultaneously and will likely delay the production
of data which can be reported to providers if provider claims are not
submitted in a timely manner.
Response: We appreciate the commenter's interest in clarification
on the timelines related to implementation of the assessment changes
required for the submission of the standardized data for measures
finalized in this rule. The implementation of the revised assessment
instruments for data collection of the finalized measures is October 1,
2016. We appreciate the suggestion to standardize the post-acute
assessment instruments prior to finalizing the measures; however, such
an approach may not be feasible when, for example, the modification of
the instruments is a result of a new measure using new items. In that
instance, rulemaking is necessary to finalize such measures before
subsequent assessment changes can be determined. That said, we will
attempt to develop measures where appropriate from existing items. We
agree that testing is imperative and through ongoing measure
development and maintenance we apply such testing and intend to
continue to do so. Additionally, we attempt to use endorsed measures
where able, however, under certain circumstances, for reasons discussed
earlier and under our authority to do so, we may elect to propose
measures that are not endorsed. We appreciate the commenter's concern
regarding the quarterly reporting of claims data and potential delays,
although we do not foresee such an issue. Nonetheless, we will monitor
for this possibility.
Comment: Several commenters suggested that we had inaccurately
estimated the economic impact associated with the burden of collection
of the new assessment items used to calculate the proposed quality
measures. Commenters suggested that the assessment of 0.5 minutes of
nursing staff time per each new item was too low because it didn't take
into account the time for a beneficiary to complete tasks associated
with self-care or mobility, or the time necessary to navigate through a
data entry system. One commenter also noted that the function items
take into account a person's usual function, over the course of days 1
to 3 days, which they feel implies that activities need to be assessed
multiple times, adding burden. Another commenter stated that the
economic impact analysis did not account for staff training. Similarly,
commenters stated that the economic analysis did not factor in the
providers' software and hardware costs. We also received a comment
pertaining to changes in payer source during a resident's stay, noting
a concern that adding additional payer sources could also add
additional burden. We also received a comment requesting that CMS
provide additional payment to the providers during the time that they
implement the new assessment items.
Response: We appreciate the concerns related to the assessment of
costs associated with the data collection for the SNF QRP. In response
to commenters' concerns regarding our estimate of nursing facility
staff time per item, we would like to clarify that this is an estimate
only of the time spent determining and documenting the score following
the observation of the patient. The burden-related estimates used to
evaluate the economic impact are based on assessment data coding and
would not take into account computer system delays or other such
features. In response to the comment regarding multiple assessments
required to assess usual function by the new section GG function items,
we would like to clarify that only one score is reported for each item
in section GG, the resident's usual performance. Clinicians assess the
resident's functional abilities once or several times during an
assessment period as part of routine practice. Consistent with the
current function items in the MDS (section G), section GG considers the
resident's ability to perform an activity across the entire assessment
period. Such clinical assessment and data collection is based upon
customary and best practices that we believe would be occurring. We
also note that, to minimize burden on providers, these items are only
required for data collection at the time of admission and discharge.
Further, to ensure minimal burden the new items found in section GG, we
include several gateway questions that allow the clinician to skip
questions in the data set that are not appropriate for an individual
patient in order to reduce burden. We have instituted skip options so
that the final number of items assessed per patient is limited
depending on their complexity and capabilities. Therefore, although all
of the items are available for assessment, we have built in mechanism
that enables the assessor to include assessment information as, and
when, appropriate.
With regard to the commenter's concerns surrounding training and
software/hardware costs, we recognize that with item set changes, there
are necessary training and software updates that may be needed.
Although the burden estimate would not be a reflection of individual
provider training needs, or those related to software and hardware, we
do include in the cost estimates cost pertaining to overhead. That
said, CMS provides free of charge the submission specifications,
[[Page 46457]]
as well as free, downloadable software to providers and we intend to
provide provider based training that would be free of charge, as we
have done in the past. With regard to increased costs associated with
all payer data capture, there already exists administrative-related
data capture in the MDS 3.0, and therefore, such data capture, should
we require all payer data in the future, would not come with additional
burden.
We believe that we have accounted for the costs of reporting data
in our burden estimates, as they are doubled to provide for overhead
and fringe benefits, which should include costs associated with any
required staff training related to the collection of new items.
However, additionally, we do not include in our burden estimates the
time that it takes providers to enter the data into their systems, as
this is a part of routine clinical care and medical charting, and the
data we require providers to report is routine in this respect as well.
Having carefully considered the comments we received on our
proposal pertaining to the Data Collection Requirements for the FY 2018
Payment Determination and Subsequent Years, we are finalizing the
policy as proposed.
For the FY 2018 payment determination, we proposed that SNFs submit
data on the three proposed quality measures for residents who are
admitted to the SNF on and after October 1, 2016, and discharged from
the SNF up to and including December 31, 2016, using the data
submission schedule that we proposed in this section.
We proposed to collect a single quarter of data for FY 2018 to
remain consistent with the usual October release schedule for the MDS,
to give SNFs a sufficient amount of time to update their systems so
that they can comply with the new data reporting requirements, and to
give CMS a sufficient amount of time to determine compliance for the FY
2018 program. The proposed use of one quarter of data for the initial
year of quality reporting is consistent with the approach we used to
implement a number of other QRPs, including the LTCH, IRF, and Hospice
QRPs.
We also proposed that following the close of the reporting quarter,
October 1, 2016, through December 31, 2016, for the FY 2018 payment
determination, SNFs would have an additional 5\1/2\ months to correct
and/or submit their quality data. Consistent with the IRF QRP, we
proposed that the final deadline for submitting data for the FY 2018
payment determination would be May 15, 2017. We further proposed that
for the FY 2019 payment determination, we would collect data from the
2nd through 4th quarters of FY 2017 (that is, data for residents who
are admitted from January 1st and discharged up to and including
September 30th) to determine whether a SNF has met its quality
reporting requirements for that FY. Beginning with the FY 2020 payment
determination, we proposed to move to a full year of FY data
collection. We intended to propose the FY 2019 payment determination
quality reporting data submission deadlines in future rulemaking.
Table 11--Proposed Measures, Data Collection Source, Data Collection Period and Data Submission Deadlines
Affecting the FY 2018 Payment Determination
----------------------------------------------------------------------------------------------------------------
Data collection Proposed data Proposed data submission deadline
Quality measure source collection period for FY 2018 payment determination
----------------------------------------------------------------------------------------------------------------
NQF #0678: Percent of Patients MDS 10/01/16-12/31/16 May 15, 2017.
or Residents with Pressure
Ulcers that are New or
Worsened.
NQF #0674: Application of MDS 10/01/16-12/31/16 May 15, 2017.
Percent of Residents
Experiencing One or More Falls
with Major Injury (Long Stay).
NQF #2631:* Application of MDS 10/01/16-12/31/16 May 15, 2017.
Percent of Long-Term Care
Hospital Patients with an
Admission and Discharge
Functional Assessment and a
Care Plan that Addresses
Function.
----------------------------------------------------------------------------------------------------------------
* Status: NQF-endorsed on July 23, 2015, please see: https://www.qualityforum.org/ProjectMeasures.aspx?projectID=73867, see NQF #2631.
We invited public comment on Proposed Measures, Data Collection
Source, Data Collection Period and Data Submission Deadlines Affecting
the FY 2018 Payment Determination. The comments we received on this
topic, with their responses, appear below.
Comment: One commenter expressed support for CMS's proposed timing
for new SNFs to begin reporting quality data. One commenter requested
that data from the MDS be made publicly available sooner than 2 years
after the specified application date for the measure. The commenter
suggested that collecting only one quarter of data between October 1
and December 31, 2016 is not sufficient to establish data trending. The
commenter requested that at least 2 quarters be used for FY 2018
payment determination, and by FY 2019 a full year's worth of data
should be used. Another commenter expressed that facilities should not
be given 5\1/2\ months to submit or correct their quarterly data.
Response: We appreciate the suggestion regarding extending the
timing of data collection to establish sufficient data trending. We
proposed to collect a single quarter of data for FY 2018 to remain
consistent with the usual October release for the MDS, to give SNFs a
sufficient amount of time to update their systems so that they can
comply with the new data reporting requirements, and to give CMS a
sufficient amount of time to determine compliance for the FY 2018
program. The proposed use of one quarter of data for the initial year
of quality reporting is consistent with the approach we used to
implement a number of other QRPs, including LTCH, IRF, and Hospice
QRPs. With regard to the 5\1/2\ month post-data collection period, this
Proposed Data Submission timeframe and final deadline for FY 2018
Payment Determination is to allow providers an opportunity to ensure
that the data from the collection period has been submitted and is
accurate and corrections, where necessary, have been made. We have
aligned these timeframes with the LTCH, and IRF and other QRPs. We
appreciate and will take into consideration the commenter's suggestion
to implement public reporting sooner.
Final Decision: Having carefully considered the comments we
received on Proposed Measures, Data Collection Source, Data Collection
Period and Data Submission Deadlines Affecting the FY 2018 Payment
Determination we are finalizing the policy as proposed.
[[Page 46458]]
h. SNF QRP Data Completion Thresholds for the FY 2018 Payment
Determination and Subsequent Years
We proposed that, beginning with the FY 2018 payment determination,
SNFs must report all of the data necessary to calculate the proposed
quality measures on at least 80 percent of the MDS assessments that
they submit. We proposed that a SNF has reported all of the data
necessary to calculate the measures if the data actually can be used
for purposes of calculating the quality measures, as opposed to, for
example, the use of a dash [-], to indicate that the SNF was unable to
perform a pressure ulcer assessment.
We believe that because SNFs have long been required to submit MDS
assessments for other purposes, SNFs should easily be able to meet this
proposed requirement for the SNF QRP. Our proposal to set reporting
thresholds is consistent with policies we have adopted for the Long-
Term Care Hospital (79 FR 50314), Inpatient-Rehabilitation Hospital (79
FR 45923) and Home Health (79 FR 66079) QRPs.
Although we proposed to adopt an 80 percent threshold initially, we
stated our intention to propose to raise the threshold level for
subsequent program years through future rulemaking.
We also proposed that for the FY 2018 SNF QRP, any SNF that does
not meet the proposed requirement that 80 percent of all MDS
assessments submitted contain 100 percent of all data items necessary
to calculate the SNF QRP measures would be subject to a reduction of 2
percentage points to its FY 2018 market basket percentage.
We invited comment on the proposed SNF QRP data completion
requirements. The comments we received on this topic, with their
responses, appear below.
Comment: One commenter expressed support for the application of a 2
percent penalty for incomplete reporting of the quality data necessary
to calculate NQF endorsed measures. This commenter states that this
support extends only to those measures with NQF endorsement as they
believe that the 2 percent incentive would ensure that providers are
collecting data necessary to implement the IMPACT Act.
Response: Section 1888(e)(6)(A)(i) of the Act requires that, for
FYs beginning with FY 2018, if a SNF does not submit data, as
applicable, on quality and resource use and other measures in
accordance with section 1888(e)(6)(B)(i)(II) of the Act and
standardized patient assessment in accordance with section
1888(e)(6)(B)(i)(III) of the Act for such FY, the Secretary must reduce
the SNF's market basket percentage described in section
1888(e)(5)(B)(ii) of the Act by 2 percentage points. As we have
discussed above, we are not limited to adopting for the SNF QRP only
measures that have been endorsed by the NQF, and to the extent that a
SNF fails to satisfactorily report one or more SNF QRP measures that
are not NQF-endorsed, we would be statutorily obligated to reduce the
SNF's market basket percentage for the applicable fiscal year by 2
percentage points.
Comment: One commenter does not support the proposed 80 percent
threshold for completion of all of the data necessary to calculate the
quality measure. This commenter expressed concern that data could be
omitted resulting in negative quality measure results. Their
recommendation is to increase the threshold to 90 percent. Another
commenter recommended lowering the threshold from 80 percent to 40
percent during the first 2 years of data collection.
Response: Our proposal to set reporting thresholds is consistent
with policies we have adopted for the Long-Term Care Hospital (79 FR
50314), Inpatient-Rehabilitation Hospital (79 FR 45923) and Home Health
(79 FR 66079) QRPs. SNF providers have been submitting the MDS for many
years and we disagree that we should lower the submission threshold as
suggested. However, we intend to reevaluate our threshold over time and
will propose to modify it, if warranted, based on our analysis.
Comment: One commenter requested clarification on what constitutes
data that is ``satisfactorily'' submitted.
Response: We are finalizing that data will have been satisfactorily
submitted for the FY 2018 SNF QRP if the SNF has reported all of the
data necessary to calculate the finalized measures and that the data
can actually be used for purposes of calculating the quality measures,
as opposed to, for example, the use of a dash [-], to indicate that the
SNF was unable to perform a pressure ulcer assessment.
After consideration of the public comments received, we are
finalizing the adoption of the policy for SNF QRP Data Completion
Thresholds for the FY 2018 Payment Determination and Subsequent Years
as proposed.
i. SNF QRP Data Validation Requirements for the FY 2018 Payment
Determination and Subsequent Years
To ensure the reliability and accuracy of the data submitted under
the SNF QRP, we proposed to adopt policies and processes for validating
the data submitted under the SNF QRP in future rulemaking. We received
the following comments on elements we should consider including in such
a process:
Comment: One commenter expressed concern that CMS is not ensuring
that the data submitted by SNFs is accurate. Specifically, the
commenter suggested that self-reported MDS data are unreliable and are
subject to gaming and that a variety of media outlets and CMS itself
have reported on data accuracy concerns. The commenter suggested that
facilities may electively omit data for residents whose health is
deteriorating. The commenter supported CMS asking for the
identification of elements to validate the data that SNFs submit and
suggested several ways that CMS may validate the data. Another
commenter recommended that CMS revisit the 2014 MDS-focused survey
process assessing MDS Version 3.0 coding practices to help inform SNF
QRP validation requirements.
Response: We appreciate the concerns pertaining to gaming and note
that we will apply a threshold for reporting of complete resident data
for the FY 2018 SNF QRP. As part of our compliance analysis, we intend
to carefully monitor rates of missing data across all facilities.
Further, we intend to align with other QRPs and propose through future
rulemaking data validation policies.
Comment: One commenter suggested several recommendations for
elements CMS should include to ensure the reliability and accuracy of
data submitted for the SNF QRP. CMS should explore a combination of
pure data checks to identify inconsistencies that exist between items
relevant to the SNF QRP and other items reported in the MDS and audit
suspicious data patterns. Another commenter suggested providing a list
of validation checks that could be used by both providers and vendors
to help improve the accuracy of data. Another commenter recommended
public reporting on Nursing Home Compare when facilities submit invalid
data and stricter regulations that require specific penalties for
violations of resident assessment requirements.
Response: We appreciate the commenters' suggestions to ensure data
accuracy such as a combination of pure data checks to identify
inconsistencies. We agree with this approach and intend to perform such
monitoring as part of overall programmatic monitoring and evaluation.
We encourage providers to engage in available opportunities to improve
the accuracy of their data. We appreciate the suggestion that we make
public on Nursing Home Compare when facilities submit to CMS invalid
data,
[[Page 46459]]
and will also take under consideration the suggestion that we implement
additional regulatory requirements on this issue.
We thank the commenters for their input on policies that we should
consider pertaining to data validation and accuracy analysis.
j. SNF QRP Submission Exception and Extension Requirements for the FY
2018 Payment Determination and Subsequent Years
Our experience with other QRPs has shown that there are times when
providers are unable to submit quality data due to extraordinary
circumstances beyond their control (for example, natural, or man-made
disasters). Other extenuating circumstances are reviewed on a case-by-
case basis. We have defined a ``disaster'' as any natural or man-made
catastrophe which causes damages of sufficient severity and magnitude
to partially or completely destroy or delay access to medical records
and associated documentation. Natural disasters could include events
such as hurricanes, tornadoes, earthquakes, volcanic eruptions, fires,
mudslides, snowstorms, and tsunamis. Man-made disasters could include
such events as terrorist attacks, bombings, floods caused by man-made
actions, civil disorders, and explosions. A disaster may be widespread
and impact multiple structures or be isolated and impact a single site
only.
In certain instances of either natural or man-made disasters, a SNF
may have the ability to conduct a full resident assessment, and record
and save the associated data either during or before the occurrence of
the extraordinary event. In this case, the extraordinary event has not
caused the facility's data files to be destroyed, but it could hinder
the SNF's ability to meet the QRP's data submission deadlines. In this
scenario, the SNF would potentially have the ability to report the data
at a later date, after the emergency has passed. In such cases, a
temporary extension of the deadlines for reporting might be
appropriate.
In other circumstances of natural or man-made disaster, a SNF may
not have had the ability to conduct a full resident assessment, or to
record and save the associated data before the occurrence of the
extraordinary event. In such a scenario, the facility may not have
complete data to submit to CMS. We believe that it may be appropriate,
in these situations, to grant a full exception to the reporting
requirements for a specific period of time.
We do not wish to penalize SNFs in these circumstances or to unduly
increase their burden during these times. Therefore, we proposed a
process for SNFs to request and for us to grant exceptions and
extensions with respect to the quality data reporting requirements of
the SNF QRP for one or more quarters, beginning with the FY 2018
payment determination, when there are certain extraordinary
circumstances beyond the control of the SNF. When an exception or
extension is granted, we would not reduce the SNF's PPS payment for
failure to comply with the requirements of the SNF QRP.
We proposed that if a SNF seeks to request an exception or
extension for the SNF QRP, the SNF should request an exception or
extension within 90 days of the date that the extraordinary
circumstances occurred. The SNF may request an exception or extension
for one or more quarters by submitting a written request to CMS that
contains the information noted below, via email to the SNF Exception
and Extension mailbox at SNFQRPReconsiderations@cms.hhs.gov. Requests
sent to CMS through any other channel will not be considered as valid
requests for an exception or extension from the SNF QRP's reporting
requirements for any payment determination.
We note that the subject of the email must read ``SNF QRP Exception
or Extension Request'' and the email must contain the following
information:
SNF CCN;
SNF name;
CEO or CEO-designated personnel contact information
including name, telephone number, email address, and mailing address
(the address must be a physical address, not a post office box);
SNF's reason for requesting an exception or extension;
Evidence of the impact of extraordinary circumstances,
including but not limited to photographs, newspaper and other media
articles; and
A date when the SNF believes it will be able to again
submit SNF QRP data and a justification for the proposed date.
We proposed that exception and extension requests be signed by the
SNF's CEO or CEO-designated personnel, and that if the CEO designates
an individual to sign the request, the CEO-designated individual has
the appropriate authority to submit such a request on behalf of the
SNF. Following receipt of the email, we will: (1) Provide a written
acknowledgement, using the contact information provided in the email,
to the CEO or CEO-designated contact notifying them that the request
has been received; and (2) provide a formal response to the CEO or any
CEO-designated SNF personnel, using the contact information provided in
the email, indicating our decision.
This proposal does not preclude us from granting exceptions or
extensions to SNFs that have not requested them when we determine that
an extraordinary circumstance, such as an act of nature, affects an
entire region or locale. If we make the determination to grant an
exception or extension to all SNFs in a region or locale, we proposed
to communicate this decision through routine communication channels to
SNF s and vendors, including, but not limited to, issuing memos,
emails, and notices on our SNF QRP Web site once it is available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-QR-Reconsideration-and-ExceptionExtension.html.
We also proposed that we may grant an exception or extension to
SNFs if we determine that a systemic problem with one of our data
collection systems directly affected the ability of the SNF to submit
data. Because we do not anticipate that these types of systemic errors
will happen often, we do not anticipate granting an exception or
extension on this basis frequently.
If a SNF is granted an exception, we will not require that the SNF
submit any measure data for the period of time specified in the
exception request decision. If we grant an extension to a SNF, the SNF
will still remain responsible for submitting quality data collected
during the timeframe in question, although we will specify a revised
deadline by which the SNF must submit this quality data.
We also proposed that any exception or extension requests submitted
for purposes of the SNF QRP will apply to that program only, and not to
any other program we administer for SNFs such as survey and
certification. MDS requirements, including electronic submission,
during Declared Public Health Emergencies can be found at FAQs K-5, K-
6, and K-9 on the following link: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/downloads/AllHazardsFAQs.pdf.
We intend to provide additional information pertaining to
exceptions and extensions for the SNF QRP, including any additional
guidance, on the SNFQRP Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-QR-Reconsideration-and-ExceptionExtension.html. We invited public comment on these proposals
for seeking and being granted exceptions
[[Page 46460]]
and extensions to the quality reporting requirements. The following is
a summary of the comments received and our responses.
Comment: Many commenters expressed strong support for the creation
of an exception and extension request process for SNFs that experience
disasters or other extraordinary circumstances.
Response: We thank the commenters for their comments and support.
After consideration of the public comments received, we are
finalizing the adoption of the policy for SNF QRP Submission Exception
and Extension Requirements for the FY 2018 Payment Determination and
Subsequent Years.
k. SNF QRP Reconsideration and Appeals Procedures for the FY 2018
Payment Determination and Subsequent Years
At the conclusion of the required quality data reporting and
submission period, we will review the data received from each SNF
during that reporting period to determine if the SNF met the quality
data reporting requirements. SNFs that are found to be noncompliant
with the reporting requirements for the applicable FY will receive a 2
percentage point reduction to their market basket percentage update for
that FY.
We are aware that some of our other QRPs, such as the HIQR Program,
the LTCHQR Program, and the IRF QRP include an opportunity for the
providers to request a reconsideration of our initial non-compliance
determination. Therefore, to be consistent with other established QRPs
and to provide an opportunity for SNFs to seek reconsideration of our
initial non-compliance decision, we proposed a process that will enable
a SNF to request reconsideration of our initial non-compliance decision
in the event that it believes that it was incorrectly identified as
being non-compliant with the SNF QRP reporting requirements for a
particular FY.
For the FY 2018 payment determination, and that of subsequent
years, we proposed that a SNF would receive a notification of
noncompliance if we determine that the SNF did not submit data in
accordance with the data reporting requirements with respect to the
applicable FY. The purpose of this notification is to put the SNF on
notice of the following: (1) That the SNF has been identified as being
non-compliant with the SNF QRP's reporting requirements for the
applicable FY; (2) that the SNF will be scheduled to receive a
reduction in the amount of two percentage points to its market basket
percentage update for the applicable FY; (3) that the SNF may file a
request for reconsideration if it believes that the finding of
noncompliance is erroneous, has submitted a request for an extension or
exception that has not yet been decided, or has been granted an
extension or exception; and (4) that the SNF must follow a defined
process on how to file a request for reconsideration, which will be
described in the notification. We would only consider requests for
reconsideration after an SNF has been found to be noncompliant.
Notifications of noncompliance and any subsequent notifications
from CMS would be sent via a traceable delivery method, such as
certified U.S. mail or registered U.S. mail, or through other
practicable notification processes, such as a report from CMS to the
provider as a Certification and Survey Provider Enhanced Reports
(CASPER) report, that will provide information pertaining to their
compliance with the reporting requirements for the given reporting
cycle. To obtain the CASPER report, providers should access the CASPER
Reporting Application. Information on how to access the CASPER
Reporting Application is available on the Quality Improvement
Evaluation System (QIES) Technical Support Office Web site (direct
link), https://web.qiesnet.org/qiestosuccess/. Once access is
established providers can select ``CASPER Reports'' link. The ``CASPER
Reports'' link will connect a SNF to the QIES National System Login
page for CASPER Reporting.
We invited comments on the most preferable delivery method for the
notice of non-compliance, such as U.S. Mail, email, CASPER, etc. The
comments we received on this topic, with their responses, appear below.
Comment: One commenter suggested the use of QIES to communicate
notices of non-compliance. Another commenter suggested that non-
compliance notifications be sent via multiple mechanisms to ensure
delivery, including CASPER reports and a traceable delivery method.
Response: We intend to provide further guidance regarding the
delivery method for the notices of non-compliance in future rulemaking.
We proposed to disseminate communications regarding the
availability of compliance reports in the CASPER reports through
routine channels to SNFs and vendors, including, but not limited to
issuing memos, emails, Medicare Learning Network (MLN) announcements,
and notices on our SNF QRP Web site once it is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-QR-Reconsideration-and-ExceptionExtension.html.
A SNF would have 30 days from the date of the initial notification
of noncompliance to submit to us a request for reconsideration. This
proposed time frame allows us to balance our desire to ensure that SNFs
have the opportunity to request reconsideration with our need to
complete the process and provide SNFs with our reconsideration decision
in a timely manner. We proposed that a SNF may withdraw its request at
any time and may file an updated request within the proposed 30-day
deadline. We also proposed that, in very limited circumstances, we may
grant a request by a SNF to extend the proposed deadline for
reconsideration requests. It would be the responsibility of a SNF to
request an extension and demonstrate that extenuating circumstances
existed that prevented the filing of the reconsideration request by the
proposed deadline.
We also proposed that as part of the SNF's request for
reconsideration, the SNF would be required to submit all supporting
documentation and evidence demonstrating full compliance with all SNF
QRP reporting requirements for the applicable FY, that the SNF has
requested an extension or exception for which a decision has not yet
been made, that the SNF has been granted an extension or exception, or
has experienced an extenuating circumstance as defined in section
III.D.3.j. of this rule but failed to file a timely request of
exception. We proposed that we would not review any reconsideration
request that fails to provide the necessary documentation and evidence
along with the request.
The documentation and evidence may include copies of any
communications that demonstrate the SNF's compliance with the SNF QRP,
as well as any other records that support the SNF's rationale for
seeking reconsideration, but should not include any protected health
information (PHI). We intended to provide a sample list of acceptable
supporting documentation and evidence, as well as instructions for SNFs
on how to retrieve copies of the data submitted to CMS for the
appropriate program year in the future on our SNF QRP Web site at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-QR-Reconsideration-and-ExceptionExtension.html.
We proposed that a SNF wishing to request a reconsideration of our
initial
[[Page 46461]]
noncompliance determination would be required to do so by submitting an
email to the following email address:
SNFQRPReconsiderations@cms.hhs.gov. Any request for reconsideration
submitted to us by a SNF would be required to follow the guidelines
outlined on our SNF QRP Web site once it is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-QR-Reconsideration-and-ExceptionExtension.html.
All emails must contain a subject line that reads ``SNF QRP
Reconsideration Request.'' Electronic email submission is the only form
of reconsideration request submission that will be accepted by us. Any
reconsideration requests communicated through another channel
including, but not limited to, U.S. Postal Service or phone, will not
be considered as a valid reconsideration request.
We proposed that a reconsideration request include the following
information:
SNF CMS Certification Number (CCN);
SNF Business Name;
SNF Business Address;
The CEO contact information including name, email address,
telephone number and physical mailing address; or
The CEO-designated representative contact information including
name, title, email address, telephone number and physical mailing
address; and
CMS identified reason(s) for non-compliance from the non-
compliance notification; and
The reason(s) for requesting reconsideration
The request for reconsideration must be accompanied by supporting
documentation demonstrating compliance.
Following receipt of a request for reconsideration, we will provide
an email acknowledgment, using the contact information provided in the
reconsideration request, to the CEO or CEO-designated representative
that the request has been received. Once we have reached a decision
regarding the reconsideration request, an email will be sent to the SNF
CEO or CEO-designated representative, using the contact information
provided in the reconsideration request, notifying the SNF of our
decision.
We also proposed that the notifications of our decision regarding
reconsideration requests may be made available through the use of
CASPER reports or through a traceable delivery method, such as
certified U.S. mail or registered U.S. mail. If the SNF is dissatisfied
with the decision rendered at the reconsideration level, the SNF may
appeal the decision to the PRRB under 42 CFR 405.1835. We believe this
proposed process is more efficient and less costly for CMS and for SNFs
because it decreases the number of PRRB appeals by resolving issues
earlier in the process. Additional information about the
reconsideration process including details for submitting a
reconsideration request will be posted in the future to our SNF QRP Web
site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-QR-Reconsideration-and-ExceptionExtension.html. We invited public comment on the proposed
procedures for reconsideration and appeals. The following is a summary
of the comments received and our responses.
Comment: Many commenters supported the policy to allow SNFs an
opportunity to submit reconsideration requests. One commenter
recommended extending the appeal timeline from 30 to 45 days if CMS
does not provide for a timely notification method.
Response: To remain consistent with our other QRPs which have
successfully implemented a reconsideration process, we believe that 30
days is sufficient.
Final Decision: After consideration of the public comments
received, we are finalizing the adoption of the policy for SNF QRP
Reconsideration and Appeals Procedure for the FY 2018 Payment
Determination and Subsequent Years.
l. Public Display of Quality Measure Data for the SNF QRP
Section 1899B(g)(1) of the Act requires the Secretary to provide
for the public reporting of SNF provider performance on the quality
measures specified under subsection (c)(1) and the resource use and
other measures specified under subsection (d)(1) by establishing
procedures for making available to the public data and information on
the performance of individual SNFs with respect to the measures. Under
section 1899B(g)(2) of the Act, such procedures must be consistent with
those under section 1886(b)(3)(B)(viii)(VII) of the Act and also allow
SNFs the opportunity to review and submit corrections to the data and
other information before it is made public. Section 1899B(g)(3) of the
Act requires that the data and information be made publicly available
not later than 2 years after the specified application date applicable
to such a measure and provider. Finally, section 1899B(g)(4)(B) of the
Act requires such procedures be consistent with sections 1819(i) and
1919(i) of the Act. We stated our intention to propose details related
to the public display of quality measures in the future. The following
is a summary of the comments received and our responses.
Comment: One commenter suggested that CMS replace or add to the
existing measures on Nursing Home Compare when measures that meet the
IMPACT Act requirements are adopted. This commenter further suggested
adjustment to the thresholds used in assigning Star Ratings to the
quality measures, and cautioned CMS to compare SNFs against performance
of meaningful scores on the quality measures rather than against their
respective rankings. The commenter also suggested the formation of a
TEP to develop a method on how to publicly report in a single cross-
setting report that compares PAC performance across PAC providers, as
well as assist in the development of meaningful targets on quality
measures. One commenter stated that the imposition of a financial
penalty should be publicly reported.
Response: We will take these recommendations into consideration as
we develop the process for the public display of data and information
on the performance of individual SNFs with respect to the measures.
m. Mechanism for Providing Feedback Reports to SNFs
Section 1899B(f) of the Act requires the Secretary to provide
confidential feedback reports to post-acute care providers on their
performance with respect to the measures specified under subsections
(c)(1) and (d)(1), beginning 1 year after the specified application
date that applies to such measures and PAC providers. We intended to
provide detailed procedures to SNFs on how to obtain their confidential
feedback reports on the SNF QRP Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting.html. The following is a
summary of the comments received and our responses.
Comment: One commenter recommended that CMS use the same mechanism
currently used by SNFs for previewing Five Star data and allow SNFs to
preview all of the quality measures on Nursing Home Compare. The
commenter also suggested that CMS use the QIES system so that all SNFs
can preview their individual reports on a weekly basis.
Response: We will take the suggestion into consideration as we
develop the mechanism for providing feedback reports to SNFs.
[[Page 46462]]
4. Staffing Data Collection
a. Background and Statutory Authority
Section 1819(d)(1)(A) of the Act for SNFs and section 1919(d)(1)(A)
of the Act for NFs each state that, in general, a facility must be
administered in a manner that enables it to use its resources
effectively and efficiently to attain or maintain the highest
practicable physical, mental, and psychosocial well-being of each
resident. Sections 1819(d)(4)(B) and 1919(d)(4)(B) of the Act give the
Secretary authority to issue rules, for SNFs and NFs respectively,
relating to the health, safety and well-being of residents and relating
to the physical facilities thereof.
The Affordable Care Act of 2010 (Pub. L. 111-148, March 23, 2010)
added a new section 1128I to the Act to promote greater accountability
for LTC facilities (defined under section 1128I(a) of the Act as SNFs
and nursing facilities). As added by the Affordable Care Act, section
1128I(g) pertains to the submission of staffing data by LTC facilities,
and specifies that the Secretary, after consulting with state long-term
care ombudsman programs, consumer advocacy groups, provider stakeholder
groups, employees and their representatives and other parties the
Secretary deems appropriate, shall require a facility to electronically
submit to the Secretary direct care staffing information, including
information for agency and contract staff, based on payroll and other
verifiable and auditable data in a uniform format according to
specifications established by the Secretary in consultation with such
programs, groups, and parties. The statute further requires that the
specifications established by the Secretary specify the category of
work a certified employee performs (such as whether the employee is a
registered nurse, licensed practical nurse, licensed vocational nurse,
certified nursing assistant, therapist, or other medical personnel),
include resident census data and information on resident case mix, be
reported on a regular schedule, and include information on employee
turnover and tenure and on the hours of care provided by each category
of certified employees per resident per day. Section 1128I(g) of the
Act establishes that the Secretary may require submission of
information for specific categories, such as nursing staff, before
other categories of certified employees, and requires that information
for agency and contract staff be kept separate from information on
employee staffing.
b. Provisions of the Proposed Rule and Response to Comments
As part of the FY 2016 SNF PPS proposed rule, we proposed to
implement the new statutory requirement in section 1128I(g) of the Act.
Specifically, we proposed to modify current regulations applicable to
LTC facilities that participate in Medicare and Medicaid by amending
the requirements for the administration of a LTC facility at Sec.
483.75 to add a new paragraph (u), Mandatory submission of staffing
information based on payroll data in a uniform format.
During the 60-day comment period on the proposed rule, we received
approximately 22 timely comments on the staffing data collection
proposal from individuals, providers, national and regional health care
professional associations and advocacy groups. Summaries of the
proposed provisions, as well as the public comments and our responses,
are set forth below.
(1) Consultation on Specifications
As discussed in the FY 2016 SNF PPS proposed rule, we adopted a
multi-pronged strategy to comply with section 1128I(g) of the Act's
consultation requirement that includes both soliciting input from all
interested parties through the rulemaking process and ongoing
consultation with the statutorily identified entities regarding the
sub-regulatory reporting specifications that we will establish. We
invited public comment on our proposed methods for consultation on the
submission specifications. The comments we received on this topic, with
their responses, appear below.
Comment: One commenter suggested that CMS convene a TEP to design a
structure and to clearly articulate the goals and purpose of the
collected information prior to mandated reporting. Another commenter
asked where it indicated in the rule that the specifications of
staffing data would be based upon ``. . . consultation with long-term
care ombudsman programs, consumer advocacy groups, provider stakeholder
groups, employees and their representatives.'' This commenter proposed
that CMS provide the result of those consultations with the
aforementioned groups. Commenters further stated that it would seem
such information could be valuable in the formation of a rational
implementation of this particular provision of the Affordable Care Act.
Other commenters stated that the designing of the reporting process
should take into account differences among LTC providers, such as
variations in size, location, management and operations, including
differences among payroll and time and attendance systems. Those
commenters urged CMS, when implementing this new requirement, to assure
opportunity for feedback and provider representation and participation
across the full spectrum of nursing home structures and organization
types, such as large, small, urban, rural, freestanding and multiple-
site facilities, as well as regional companies and large companies.
Response: We are committed to consulting with stakeholders,
including LTC facilities, consumer advocates, and other related groups.
Through this rulemaking, we solicited input from all of the statutorily
identified entities and this final rule reflects the outcome of that
consultation. We are continuing our consultation on the sub-regulatory
specifications through a variety of mechanisms. We have a regular
dialogue with stakeholders through individual and national calls. These
stakeholders represent a wide range of facilities throughout the
country, including large and small, rural and urban, independently-
owned facilities and national chains, and we have consulted with
facilities with varying types of payroll and time keeping systems. In
addition, we published a Draft Policy Manual (``1.0'') for the
electronic staffing data submission payroll-based journal (``Draft PBJ
Policy Manual'') that offers more details of planned technical
specifications and invited comments that we continue to take into
account as we develop and refine the specifications to implement this
final rule. This manual is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html. We encourage
stakeholders to email comments and requests to NHStaffing@cms.hhs.gov
as another opportunity for consultation. We appreciate the suggestions
from commenters on other mechanisms for consultation with stakeholders
on our subregulatory specifications and we will consider these options
as we continue our dialogue and engagement efforts throughout
implementation.
(2) Scope of Submission Requirements
As noted above, section 1128(g) of the Act mandates that the
Secretary require LTC facilities ``to ``to electronically submit to the
Secretary direct care staffing information, including information for
agency and contract staff, based on payroll and other verifiable and
auditable data in a uniform format.'' The proposed rule
[[Page 46463]]
used the statutory term ``direct care staffing information'' without
elaboration. We received a number of comments regarding the scope of
this term. Those comments and our responses are set forth below.
Comment: Several commenters asked that CMS define ``direct care
staff'' and clarify the types of staff in the nursing facilities that
are included in this reporting. Several commenters recommended we use
the following definition; ``Direct care staff means those individuals
who provide care and services enabling the resident to receive the
necessary care and services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being, in
accordance with the comprehensive assessment and plan of care, as
specified in Sec. 483.25.'' A few commenters recommended using the
definition from the preamble of the October 2005 Final Rule on Posting
of Nurse Staffing Information (70 FR 62065 available at https://www.gpo.gov/fdsys/pkg/FR-2005-10-28/pdf/05-21278.pdf), which states
that direct care means that an individual is directly responsible for
resident care, which includes, but is not limited to, such activities
as assisting with activities of daily living (ADLs), performing gastro-
intestinal feeds, giving medications, supervising the care given by
CNAs, and performing nursing assessments to admit residents or notify
physicians about a change in condition. Another commenter recommended
defining direct care staff as staff having ``hands on'' care of a
patient.
Several commenters expressed concern that the Draft PBJ Policy
Manual suggested CMS planned to interpret the proposed regulation to
require reporting of information on non-direct care employees and
opined that this interpretation would go beyond what Congress intended.
One commenter stated that nowhere in the Affordable Care Act, or the
proposed rule, is there mention of the non-direct patient care services
as direct care staff. They opined that some of the employee categories
listed in the Draft PBJ Policy Manual, such as housekeeping and
dietary, are generally not considered to be individuals that perform
direct care. Commenters stated that it was not the intent of Congress
to require reporting for individuals providing non-direct care services
and that CMS's interpretation would increase the burden beyond what is
necessary, while at the same time not adding information that is
helpful to the overall goal of the program. They stated that the
interpretation by CMS of definitions of direct care staff in the Draft
PBJ Policy Manual broadens the scope and breadth of data required, and
does so to an unnecessary extent that exhibits overreach of the
legislative directive. They urged CMS to maintain internal consistency
with the definitions in section 6106 of the Affordable Care Act, the
proposed rule, the Draft PBJ Policy Manual and ultimately the final
rule, and limit this data collection to direct patient care staff
information. Commenters stated that the final rule should clarify that
direct care staffing excludes non-direct care services. In addition,
they recommended that references to non-direct care services be removed
from the Draft PBJ Policy Manual to avoid confusion and unnecessary
administrative costs for providers. Some examples the commenters
provided as extraneous to the direct care staff normally employed by
nursing homes (and that they advise should be reevaluated with
stakeholder consultation and input) are blood service workers and
vocational service workers.
Another commenter urged that CMS only collect staffing data about
direct care staff that are typically employed (or contracted by) in
nursing centers, including trained medication aides (where permitted by
state law), and not all types of staff that are currently reflected in
the CMS Form 671 (for example, housekeeping staff, administration and
storage of blood, vocational services). They also recommended that CMS
collect staffing data about additional direct care staff such as
Certified Respiratory Therapists, all therapy staff (Speech and
Language Pathologists, Physical Therapists, Occupational Therapists,
PT/OT Assistants and Aides) therapeutic recreation staff, medical
social workers, physicians and non-physician practitioners (NPPs).
Another commenter asked that CMS clearly delineate all staff
categories, including physical therapist and physical therapist
assistants. Additional comments request that CMS clarify what
categories of employees are included in ``therapist and other type of
medical personnel''.
Response: We believe that the statutory term ``direct care staffing
information'' as used in the proposed rule is self-explanatory. As
noted in the preamble to the proposed rule, facilities have a statutory
obligation to be administered in a manner that enables it to use its
resources efficiently and effectively to attain or maintain the highest
practicable physical, mental and psychosocial well-being of each
resident. We also noted that the statutory requirement to report direct
care staffing information was added to promote greater accountability
for LTC facilities in meeting this obligation. In addition, the
Congress gave context for the term ``direct care staffing information''
by including a non-exclusive list of the categories of work that may be
performed by individuals whose information would be reported. We
incorporated this non-exclusive list into the proposed rule.
Accordingly, we believe that it was clear from the proposed rule that
the reporting requirement would apply to the subset of staff at a LTC
facility whose work directly advances resident well-being. However, we
appreciate commenters desire to have specificity in the regulation.
Based on the comments received, in this final rule we add a definition
of ``Direct Care Staff'' at Sec. 483.75(u)(1). This definition is
grounded in the statutory text cited in the proposed rule and
incorporates specific text offered by commenters. ``Direct Care Staff''
is defined as those individuals who, through interpersonal contact with
residents or resident care management, provide care and services to
residents to allow them to attain or maintain the highest practicable
physical, mental, and psychosocial well-being. Direct care staff does
not include individuals whose primary duty is maintaining the physical
environment of the long term care facility (for example, housekeeping).
In this definition, we do not exclude individuals who spend time on
duties that are not always ``hands on,'' such as supervising nurses or
medication management, as these types of duties directly impact a
resident's care. Therefore, the definition focuses primarily on whether
the staff person in question provides care or services either through
``hands on'' care or through resident care management, with the
intention of benefiting the resident's well-being. We further note that
there can be significant variation in the level and type of direct care
that many staff provide. For example, a certified nurse assistant may
spend the bulk of their time delivering hands-on care directly at the
bedside, while an activities director may spend less time delivering
hands-on bedside care. As such, we intend to collect staffing data on
any staff that provides any amount of direct care.
Although comments on the Draft PBJ Policy Manual are beyond the
scope of this rulemaking, we appreciate commenters' feedback on how
this draft guidance would implement the regulatory obligations
established under this rule. We agree with commenters who stated that
the reporting obligation under this regulation should not extend
[[Page 46464]]
to non-direct care staff, as well as their assertion that individuals
who provide housekeeping are not direct care staff. As explained above,
we are following commenters' recommendation to add a definition of
direct care staff. As commenters requested, the definition of direct
care staff expressly excludes housekeeping staff as well as any other
individuals whose services are primarily related to maintaining the
physical environment of the long term care facility. We believe this
definition clarifies how CMS intends to interpret the scope of the
reporting requirement. We agree with commenters who observed the
reporting requirement should be consistently interpreted from the
statute to the regulation to the implementing guidance. We believe the
regulation is fully consistent with the statute and we will revise our
subregulatory guidance to align with provisions of this final
regulation. Finally, we note that we will take into account commenters'
feedback on the categories of direct care staff as we refine the Draft
PBJ Policy Manual.
(3) Hours Worked and Hours of Care
We proposed language for the new Sec. 483.75(u)(1)(iii) that would
require facilities to submit information on staff turnover and tenure
and on the hours of care provided by each category of staff per
resident per day (including, but limited to start date, end date (as
applicable) and hours worked for each individual.
We noted that section 1128I(g)(4) of the Act requires LTC
facilities to report on the hours of care provided by each category of
certified employees per resident per day. We expressed our belief that
the obligation to submit information on ``hours of care'' is satisfied
by requiring facilities to submit hours worked by staff. In addition,
we noted that although section 1128I(g)(2) of the Act requires the
submission of resident case mix information, the proposed rule did not
include a provision to implement this requirement because existing
regulations at Sec. 483.20 require LTC facilities to meet this
statutory requirement through the required submission of the Minimum
Data Set (MDS). Details of the comments we received on submission
requirements, with our responses, appear below.
Comment: One commenter urged CMS to be consistent with language in
the preamble and in the federal law related to ``hours worked'' and to
eliminate language requiring the reporting of hours of care provided.
Another commenter stated that they believe that CMS must find a way to
better capture hours provided than to equate it to hours worked. This
commenter suggested one approach might be to conduct time studies to
estimate the average amount of time CNAs, LPNs and RNs spend on non-
direct care tasks and subtract that time from their total hours worked.
Two commenters stated that CMS should require submission of time
employees are taking personal leave during the work day (for example,
for meals, breaks), and stated that these should not be recorded as
hours worked as they are not hours of care. They further stated that
although the language of CMS's proposed rule either quotes or
paraphrases the statutory language, proposed at Sec. 483.75(u), the
preamble suggests that ``the obligation to submit information on `hours
of care' is satisfied by requiring facilities to submit hours worked by
staff.'' (80 FR 22081). Those commenters strongly disagree with the
approach to collect hours of care worked as equivalent to hours of
care. They observed that there could be a considerable difference
between hours of care actually provided and hours of care worked. They
stated that all staff, as a matter of practice and by law, have time
when they are paid but are not working--meal and other mandated breaks,
mandatory in-service training, etc. They observed that in an eight-hour
workday, some time is devoted to meal and other mandated breaks and
although staff may be paid for this time, but they are not providing
care to residents. The commenters opined that if CMS is unwilling to
require facilities to submit hours of direct care actually provided,
then it must delete at least one hour from total hours worked in order
to reflect the time at work that is not dedicated to resident care.
Another commenter stated that CMS should require submission of time
employees are absent from the facility on work-related leave if they
are unavailable to fulfill direct care responsibilities. The commenter
stated that this should include time nurse aides spend transporting
individual residents to medical appointments since they are unavailable
to provide services to other residents during that time. Other
commenters expressed support for the proposed reporting of hours
worked, but questioned how the reporting will distinguish between
direct care hours worked and hours worked on management and other
responsibilities by a salaried employee, as might be the case for nurse
managers who split their time between direct care and management
functions. One commenter remarked that they support the many job
classifications for which the Draft PBJ Policy Manual proposes to
collect staffing information, but for both nursing and non-nursing job
classifications there needs to be more specification on how to
distinguish hours of care versus mandatory breaks or other non-direct
care duties.
Other commenters supported the reporting of hours worked, but
stated that submission specifications should account for actual hours
worked by salaried/exempt staff. They observed that exempt direct care
employees can frequently work more than the salaried time period (for
example, 40-hour basis) for which they are paid. While alternate
compensation for any additional hours will not be evident in a payroll-
based system, they suggested that the CMS staffing data collection
process should account for this additional time to accurately reflect
direct care staffing and coverage. Similarly, another commenter
observed that there are data elements that are not captured in payroll
data alone, such as time worked off of the clock for contract
employees, or the actual hours worked by the salaried employee. The
commenter stated that capturing data that includes productivity
standards and time allocated for indirect patient care would further
illuminate quality patient care that is not intuitive to payroll data
alone. The commenter suggested that this can be calculated by
collecting data for direct patient contact time, which is captured in
the MDS and/or medical record. The commenter recommended the inclusion
of direct patient contact time, as reported by speech language
pathologists or derived from the billable minutes provided on the date
of service.
Response: In our proposed approach, and in this final regulation,
we give deference to the statutory requirement that the staffing data
be reported ``based on payroll and other verifiable and auditable data
in a uniform format (according to specifications established by the
Secretary . . .).'' Payrolls represent the primary source of verifiable
and auditable information, and are explicitly referenced in the statute
as such. Payroll systems contain the key information organized as
``hours worked,'' and provide the most effective foundation for
electronic reporting. We have therefore maintained ``hours worked''.
We appreciate commenters' observation that payroll systems record
vacation, sick time, and certain other absences that are time other
than ``hours worked.'' Therefore, when LTC facilities report total
hours worked by direct care staff (based on payroll and other
verifiable and auditable data as
[[Page 46465]]
specified by CMS), these data should not include paid time off (for
example, vacation, sick leave, etc.).
At the same time, we recognize that nursing home staff engage in
other non-care and direct care activities throughout their day, such as
breaks. Although outside the scope of this rulemaking, we appreciate
that in calculating quality measures we may need to adopt some
statistical refinements that allow for reasonable estimates of such
time in order to afford the public the information that will enable
recognition of the time that staff are engaged in non-care or non-
direct care activities. Also, as required in the statute, we require
that the primary care area of each staff person (as well as each
individual's hours) be reported. Such categorization will allow the
public to identify which care areas are most important to them, as well
as to focus on the types of staff who provide most of the hands-on
care. We thank the commenters for identifying these issues, and will
take this feedback into account when assessing future uses of the data,
such as quality measures.
We further note that the regulation does not limit collection of
information to payroll data exclusively. In fact, the regulation
specifies that the information will be ``based on payroll and other
verifiable and auditable data'' (emphasis added). Although beyond the
scope of this rulemaking, we do not rule out the possibility that
future implementation specifications could require submission of
information from time studies or other methods, in addition to payroll
data, if CMS determines that other data capture methods are auditable
and verifiable. For example, if at a future date CMS concludes there
are auditable and verifiable data regarding extra hours worked by
salaried employees or hours worked that are extraneous to the care of
residents, CMS may revise the implementation specifications to address
the submission of these data that permit refinement of the payroll
data. However, as indicated in the draft subregulatory guidance
implementing this regulation, we anticipate that initial reporting will
be limited to the payroll-reported data for each individual who meets
the definition of direct care staff. We plan to continue to work with
stakeholders to further develop the initial specifications to implement
this final rule and to make any future refinements to this
subregulatory guidance.
Comment: A few commenters recognized the value of collecting and
reporting staffing information but were concerned about the
administrative burden resulting from this new reporting requirement, in
particular for hospital-based skilled-nursing facilities, where many
staff may work in both the SNF and other departments of the hospital
and health system, and where payroll systems are integrated. They urged
CMS to test the proposed data collection system specifically in SNFs
operated as distinct parts of acute care hospitals to address any
unique issues that might arise in that setting. Another commenter
observed that in their facility, attached to a hospital, the
housekeeping, laundry, maintenance, dietary, and administrative
services are provided by staff that conduct hospital and nursing home
services. The commenter explained that at their facility only the
nursing time is directly allocated to the nursing home on a timesheet;
the times worked in the other departments are allocated to their
individual departments. The commenter observed that at the end of the
year when the cost report is prepared, their time is separated out to
the revenue producing departments (nursing home, medical/surgical, ER,
lab, radiology, etc.) based on meals served, square footage, pounds of
laundry, etc. The commenter stated that, currently, this information
will not be able to be sent directly from their payroll system and that
it will be extremely time consuming to figure out the percentage of
time a support service department employee worked for the nursing home
each day and manually enter it into the Payroll-Based Journal system.
The commenter observed that the cost report already provides a summary
of staffing salaries and hours, and suggested that the cost report
could be modified to conform to all the Affordable Care Act
requirements. Another commenter stated that to require distinct part
SNFs to collect data on the services not related to direct patient
care, duties which are shared with the institutions where they are
housed, will create unnecessary administrative burden to separate data
for services, which are by definition shared. This works against the
entire principle behind distinct part SNFs, and is, in fact, impossible
to accomplish without hours of manual labor. For example, the commenter
observed that in their 125-bed facility they have a 38-bed ventilator
assist unit, with approximately 140 direct care staff with a 10-hour
per patient day ratio. They stated that the amount of time to submit
staffing information on this unit alone would require an inordinate
amount of resources. A hospital association stated they are concerned
that the requirement will be administratively burdensome, particularly
in light of the challenges of attributing hours worked to the distinct
part unit as opposed to the hospital generally. They opined that
therapy staff hours are now kept by department and allocated
retrospectively as part of the facility's cost report. The association
stated that the payroll system for these hospitals does not support the
automated submission of data as envisioned in this regulatory proposal.
For these types of facilities, they encouraged CMS to consider
alternative mechanisms--such as adaptions of the current cost reporting
system--to demonstrate compliance with the requirements of the statute.
Finally, a commenter stated that one of the issues involved in
reporting hours worked for non-direct care staff involves SNFs that are
hospital or retirement community based. The commenter stated that non-
direct care staff provides services to the whole organization and there
is no way to determine the number of hours specific to the SNF and
indicated that Medicare cost report methodology allows reporting of
these ``overhead'' areas based on various statistics that have no
relationship to hours. The commenter opined that to attempt to
determine the SNF related hours would result in inaccurate estimates
that would not be meaningful and would be a cumbersome manual process.
Response: We are aware that hospital-based facilities and other
facilities such as nursing homes adjacent to assisted living facilities
or part of retirement communities have staff that work in multiple
areas of the broader entity. In response to these and other comments,
in this final rule we have added a definition of ``direct care staff''
that excludes certain facility support staff. We believe that this
adjustment will help address a large portion of the staff issues that
distinct part and other conjoined entities would otherwise face with
staff who have duties in multiple entities. For the staff who do meet
the new definition of direct care staff, facilities will still need to
report the hours that are allocated to the SNF/NF residents only, and
not include hours for staff allocated for providing services to
residents in non-certified SNF/NF beds. Data reported should be
auditable and able to be verified through either payroll, invoices,
and/or tied back to a contract. Facilities must use a reasonable
methodology for calculating and reporting the number of hours allocated
to providing services on site to the SNF/NF residents, and exclude
hours allocated for providing services to other individuals in other
settings. These types of facilities are encouraged
[[Page 46466]]
to participate in the voluntary program beginning on October 1, 2015.
Voluntary submission will allow facilities to work through their
processes to submit the data in advance of the mandatory submission
period. We also note that Medicare cost reports are not an appropriate
means to comply with this staffing reporting requirement because, among
other concerns, they do not contain all of the data needed to comply
with the Act, such as information on turnover and tenure.
Comment: Several commenters opined on how the submission schedule
should apply to resident census data. Several commenters recommended
that CMS collect resident census data in a time frame consistent with
collection of other staffing data under this requirement. That is, they
recommended that if staffing data is collected quarterly, census data
should be collected quarterly. Some commenters suggested that data
regarding resident census should reflect shorter time periods than
quarterly. For example, several commenters recommended that the
resident census data submitted each quarter should include three data
points that reflect each month's total patient days in order to
accurately reflect the hours of direct care per patient per day.
Another commenter urged CMS to require facilities to collect and submit
daily resident census data to capture fluctuations around facilities'
surveys when many facilities temporarily increase staff; to reflect
reduced staffing hours caused by higher absenteeism during certain
periods such as holidays; and to reflect periods when census
unexpectedly increases, such as accommodation of residents displaced by
a facility closure. Another commenter remarked that it is their
understanding that based on the specifications contained in the Draft
PBJ Policy Manual CMS intended to interpret the proposed regulation to
require submission of census data based on the resident population as
of the last date of each month of each quarter. The commenter expressed
strong objection and concern with this approach as misrepresentative
and unreliable in depicting the hours of direct care provided per
resident per day. The commenter opined that that collection of census
information must be compared to and consistent with the data collected
for hours worked during the same submission period. The commenter
expressed the view that calculation and use of the average daily census
for each month in a quarterly submission period was strongly favored
over the current CMS proposal. Another commenter recommended that
resident census also be submitted on a daily basis to capture
fluctuations in staff-to-resident ratios that may occur during a 30-day
period that would not be recorded if data were reported only on the
last day of the month; for example, the period around the annual survey
or during a ban on admissions or closure. One commenter stated that it
is unclear how the number of days will be gathered from the submitted
data for purposes of determining hours of care per resident day. Given
the desired level of accuracy in reporting of hours worked, they
advocated for an accurate and unobtrusive method for collecting
information on the number of resident days provided in each reporting
period. Finally, a commenter stated that CMS proposes that resident
census data should be collected on the last day of each of the 3 months
within a quarter. The commenter recommended staffing data should be
collected on a daily basis, because the lack of daily resident census
data could lead to inaccurate calculation of staffing levels, and
potential inflation of staffing level averages. The commenter observed
that resident census fluctuates continually throughout the month, and
it would not be a burden for facilities to report this information
since this information is readily available at SNFs. They stated that
primary purpose of payroll-based staffing data collection is to provide
as accurate as possible staffing level information for consumers,
rather than the current system which is fairly unreliable for several
facilities as facilities ``staff-up'' near their expected inspection
survey.
Response: We recognize that a facility's census fluctuates
throughout each month and appreciate suggestions intended to promote
the utility of the census data submitted under this regulation.
However, while the requirement to submit census information is within
the scope of this rule, the specifications for this submission are not.
Therefore, these comments will be taken into account as we revise the
Draft PBJ Policy Manual and other subregulatory guidance. For example,
we will analyze the average census of a facility based on the last day
of each month as compared to the average census based on the daily
census. We will ensure that any eventual quality measure will be
statistically sound in representing a facility's census. This may
involve altering the data we propose to collect (for example, from once
a month, to daily) or collecting this information through other means.
We note that the method to submit census data described in the current
draft guidance was recommended by stakeholders who participated in the
pilot in 2012 and was structured to reduce provider burden as much as
possible.
Comment: Two commenters strongly supported the submission of nurse
staffing hours by shift to capture what they describe as the dangerous
decline that occurs in many facilities on the afternoon and night
shifts. They expressed that sufficient direct care nursing staff on one
or two shifts averaged over three shifts may hide critically deficient
nursing levels on the other(s), when residents are at increased risk of
serious harm from missed care, falls, abuse, elopement, missed meals,
and lack of assistance with toileting. They further commented that
shift-level nurse staffing hours per resident day would yield far more
important evidence of quality than minor variations in case mix in
typical nursing homes. They also noted that the Staffing Quality
Measure (SQM) project evaluated the feasibility of collecting shift
level data, concluding that it could be done and would allow
calculation of ``more detailed staffing measures, such as shift-level
staffing ratios or the proportion of shifts for which at least one
registered nurse was present.'' One commenter additionally remarked
that CMS should collect nurse staffing data by unit. They concluded
from the SQM Final Report that researchers gave only cursory attention
to requiring facilities to submit data by units. They asserted that at
a time when the industry is creating special subacute care or rehab
units to maximize Medicare census and reduce rehospitalization rates,
adequate or exceptional staffing in a subacute unit can create a false
picture of levels in other units whose residents have similar needs.
They stated that without such data, case mix adjustment would be more
likely to obscure staffing hours than to clarify them. Another
commenter recommended that staffing data be collected by shift and
unit, especially as more facilities are developing Medicare/
rehabilitation units and subacute units.
Response: We agree that data regarding staffing patterns at the
shift and/or unit level would be valuable when assessing how LTC
facilities are administered; however, these implementation
specifications are beyond the scope of this rulemaking. We will
continue to look at this as we develop subregulatory guidance and will
evaluate the feasibility of collecting these data elements in the
future.
[[Page 46467]]
Comment: One commenter recommended that CMS reconsider case-mix
adjustment of staffing hours. Another commenter expressed opposition to
making any adjustment for case mix. The commenter suggested that, at a
minimum, the non-adjusted staffing level data should be publicly
available. The commenter stated that the case-mix of residents is
changing constantly, and consumers want to know if facilities are truly
staffing near the recommended level of 4.1 hours per resident day, or
are they only near this standard due to the case-mix adjustment. One
commenter strongly objected to any language in regulations that would
require or imply that CMS will use MDS data to adjust staffing
information that is reported on Nursing Home Compare. In passing
legislation to replace inaccurate, self-reported staffing data with
information from auditable payroll records, the commenter stated that
Congress intended to ensure that the public has accurate information
about staffing hours, and that the Congress did not intend to have
information from the new system degraded by consolidation with data
from another self-reported source that is frequently inaccurate and
even fraudulent. The commenter acknowledged and welcomed the fact that
CMS is implementing nationwide, focused MDS surveys in response to
criticism of the use of MDS data to construct Quality Measures (that
are displayed on the CMS Nursing Home Compare Web site), but noted that
such focused surveys will not be conducted in all nursing homes, and
that they will be subject to the same limitations as other surveys
(such as surveyor turnover, pressure from supervisors not to cite
deficiencies, and weak enforcement).
Response: We thank commenters for their suggestions but note that
the use of case-mix or MDS data is outside the scope of this rule. We
will work with stakeholders prior to formulating publicly posted
quality measures. We will consider making both adjusted and unadjusted
data available. However, we believe that case mix adjustments are
important for the very reasons the commenters observe--that the risk
profile of a nursing home's resident population does change over time,
and is also different from one facility to another. We would expect
that a nursing home that has a population with a higher risk profile
should generally have an overall higher staffing level, or a staffing
complement that matches the risk profile (for example, higher RN levels
for a nursing home with a population that has a higher acuity level
compared to other nursing homes). We appreciate that the MDS data have
limitations but at this time we believe MDS reporting does meet the
statutory requirement for LTC facilities to submit information on
resident case-mix that are auditable and verifiable. We will also
continue to monitor the results of the new nationwide sample of
targeted MDS surveys to determine if additional actions are advisable.
Comment: One commenter stated that if the Congress' intent was to
ensure that payroll data and staffing quality measures would conform
with the minimum staffing requirements of the Nursing Home Reform Law,
which require care to be provided by Licensed Health Professionals and
nurse aides who meet the law's 75-hour training, competency evaluation,
and registry requirements, then they recommend that CMS define
``certified employees'' as staff who are licensed health professionals
and/or who meet the requirements for nurse aides, as defined in section
1819(b)(5) of the Act.
Response: The requirement for reporting staffing data is not
limited to licensed health care professionals and nurse aides. Direct
care staff includes other staff that meet the definition of direct care
staff. That said, we will provide definitions for certain categories of
staff, such as nurse aides, through implementing guidance.
(4) Distinguishing Employees From Agency and Contract Staff
Under section 1128I(g) of the Act's requirement that information
for agency and contract staff be kept separate from information on
employee staffing, we proposed to add a new Sec. 483.75(u)(2) to
establish that, when reporting direct care staffing information for an
individual, a facility must specify whether the individual is an
employee of the facility or is engaged by the facility as contract or
agency staff. We believe the statute's intent is to require LTC
facilities to submit staffing information in a manner that can enable
us to distinguish those staff that are employed by the facility from
those that are engaged by the facility under a contract or through an
agency. We do not believe the statute requires such data to be
submitted at separate times or through separate systems, which would
merely engender unnecessary costs and burden, so we intend to collect
all facility staffing information at the same time and through the same
system, employing a mechanism by which LTC facilities will clearly
specify whether staff members are employees of the facility, or engaged
under contract or through an agency.
The comments we received on this topic, with their responses,
appear below.
Comment: One commenter requested that CMS further clarify in the
Draft Payroll-Based Journal Policy Manual that ``floaters'' or other
employees that work at multiple facilities for the same operator should
be categorized as contract staff. Another commenter agreed that
facilities must indicate whether an employee is a direct employee of
the facility (exempt or non-exempt), or employed under contract paid by
the facility or through an agency. The commenter stated that CMS should
consider defining ``floaters''--individuals employed by the corporation
who may work for the same employer but in different facilities at
different times--as agency employees. Another commenter asked what the
applicable start and end dates would be that a facility would report
for contract and agency staff, since these workers can be used
intermittently over indeterminate time periods.
Response: We appreciate the commenter's insights into these
implementation issues. Although these details are beyond the scope of
this regulation; we believe they are appropriate for implementation
specifications. We will take these comments into account when issuing
the revised Draft PBJ Policy Manual and other subregulatory guidance.
(5) Data Format
We proposed to add a new Sec. 483.75(u)(3) to establish that a
facility must submit direct care staffing information in the format
specified by CMS. This provision would implement the requirement in
section 1128I(g) of the Act that facilities submit direct care staffing
information in a uniform format. As noted, we are consulting with
stakeholders on potential format specifications. The data that we
proposed for submission are similar to those already submitted by LTC
facilities to CMS on the forms CMS-671 and CMS-672 (we intended for
this proposed new information collection to eventually supplant the
data collections via the CMS-671 and CMS-672). In advance of the
proposed July 1, 2016 implementation date, we will publicize the
established format specifications and will offer training to help
facilities and other interested parties (for example, payroll vendors)
prepare to meet the requirement.
The comments we received on this topic, with their responses,
appear below.
[[Page 46468]]
Comment: One commenter stated that there should not be an
unreasonable financial burden placed on the providers to report the
information that would be required, since providers are already being
negatively affected by the sequestration and the managed care plans.
The commenter stated that even though it is a good thing to keep costs
down for the federal budget and the taxpayers, it is only the
adjustment for cost increases that has helped to minimize the negative
impact for the providers. The commenter observed that many providers
have multiple types of staff, which includes different types of payment
types from paychecks to payables. The commenter explained that this
means that for many it is not one combined system for all of the
detail, since not all of this information had been required, so it will
require either a lot of hours to prepare or a lot of hours to program
or possibly both in order to provide the information. The commenter
further stated that not all providers benefited from the incentives for
moving to an electronic record. Many were excluded from participation,
but had to bear the costs anyway due to the sharing of patients (also
called residents, clients, etc.) and the requirement to provide the
information electronically. The commenter opined that this placed an
undue hardship on them. Another commenter remarked that CMS has not
adequately considered and accounted for the costs to SNFs to comply
with the proposed data collection. Several commenters recommended that
CMS complete a regulatory analysis addressing these costs. The
commenters stated that the interpretation of the legislation by CMS
through the proposed rule would be overly burdensome, redundant, and
would create unnecessary and costly expense to distinct part SNFs. They
asserted that the steps required to supply the data outlined in the
proposal requires technical expertise, labor, and payroll system
vendors in order to meet expectations. Another commenter expressed
concern regarding the time to comply with this system proposed by CMS.
The commenter strongly encouraged CMS to solicit input from a broad
variety of providers to develop an approach that meets the requirements
of the Affordable Care Act and also is more reasonable to providers in
terms of labor and cost. The commenter expressed concern that cost of
the requirements would be obtained from the cost of direct patient care
given, as that reimbursement would not likely be increased. The
commenter stated that, if high costs were incurred, then it would be
highly unlikely that additional data requirements would have a positive
effect on the quality of nursing home services but, instead, the
potential to decrease quality is significant as more and more resources
are directed to regulatory mandates that do not affect direct patient
care. The commenter stated that they were unaware of any CMS research
or data analysis that demonstrates a direct relationship between this
level of data and quality outcomes. Finally, the commenter stated that
required reporting of non-direct patient care staffing data reduces the
ability to provide quality care, as resources are diverted to
administrative reporting, away from direct patient care. Another
commenter opined that the proposed rule and the inclusion of the
additional staffing data required by the Draft PBJ Policy Manual extend
beyond the intent and language of the Affordable Care Act and that this
is an unreasonable and costly additional administrative burden which
does not improve patient care at a time when delivering quality care at
a reasonable cost is paramount public policy; adding undue hardship
which does not improve quality will have a definite negative impact on
care. One commenter recommended that CMS recognize that this new
process is occurring at the same time as several other mandates that
require significant resource investment, including the initiation of
ICD-10 and the training and software preparation needed. The commenter
identified other concurrent provider efforts including initiation of
the collection of data for the Quality Reporting Program related to the
IMPACT Act, the initiation of 30-day all-cause, all-condition
rehospitalization reporting, ongoing transition to electronic health
records at many facilities, and the initiation of computerized
physician order entry (CPOE) at facilities and all while providers work
to increased interoperability so that data can be exchanged. One
commenter supported the electronic collection of staffing data by CMS
but noted that the system for doing this should be reasonable and
achievable and as simple as possible. Commenters were also concerned
that payroll vendors were not yet prepared to accommodate the required
reporting and that providers would incur compliance costs associated
with modifying their own payroll systems or from vendors needing to
make these modifications. One commenter stated that every employee will
need to have a unique employee number assigned for tracking and
reporting purposes that may require payroll and other systems
modifications. Another commenter suggested CMS delay the mandatory
electronic submission of staffing data until CMS has adequately tested
the submission system and determined the cost and burden to providers
to comply with this proposed regulation. The commenter observed that
only the volunteer facilities will have had an opportunity to test the
new system prior to the mandatory report date of July 1, 2016 that
applies to all facilities.
Response: We appreciate commenters concerns about the costs
associated with submitting direct care staffing information but note
that this reporting obligation mandated by section 1128I(g) of the Act.
We believe this final rule is fully consistent with the intent and text
of the statute and represents the best approach to minimize the burdens
associated with implementing the statutory reporting requirement. Based
on the comments received, we have included information on the estimated
costs and burden of this regulation to facilities in section V. of this
final rule. As noted above, we will continue our consultation with LTC
facilities and other stakeholders as we revised the Draft PBJ Policy
Manual and other implementation guidance to implement this regulation.
Comment: Several commenters suggested that CMS modify already-
existing reports and/or reporting systems to develop the uniform format
to be used for staff reporting submission under this new regulation.
Many commenters suggested that their cost reports could be modified to
conform to all the Affordable Care Act requirements. One commenter
stated that CMS should consider using staffing data that is collected
for other programs which could, with minor adjustments, be used to meet
the requirements of the Affordable Care Act. The commenter suggested
that Medicare Cost Reports collect similar data which is obtained on a
regular basis and a modified format of this form would result in less
burden for providers and fewer opportunities for discrepancies in
information provided in multiple reporting forms. Two commenters stated
that the requirements of section 6106 of the Affordable Care Act could
be met, consistent with the intent of the Congress, through the
existing resident case-mix report without creating an additional
duplicative report. The commenters stated that the report could be
expanded to include the other requirements of the Affordable Care Act:
Aggregate nursing hours, number of patient days, and staff turnover to
be reported quarterly. Another commenter
[[Page 46469]]
suggested CMS work with states already collecting this information to
reduce the reporting burden for facilities.
Response: In order to comply with section 1128I(g) of the Act, the
final rule mandates that there be a uniform national method of
electronically collecting specific staffing data that can be applied
for both Medicare SNFs and Medicaid nursing facilities. When
implementing this regulation we will adopt a system that will
accommodate this requirement. We do not agree that the Medicare cost
reports or existing state-based systems will satisfy the requirements
of the law. For example, Medicare cost reports do not contain the data
needed to comply with the Act, such as information on turnover and
tenure.
Comment: One commenter suggested in Sec. 483.75(u)(3) after the
heading adding ``uniform'' before ``format'' for consistency between
the statutory and regulatory text and for clarity in the requirement
for submission of data in a uniform format.
Response: We agree. For consistency purposes, we have added
``uniform'' before ``format'' in the text of Sec. 483.75(u)(3)
(6) Effective Date for Submission Requirement
In the proposed rule, we indicated that the regulation would take
effect on July 1, 2016. We explained that prior to this effective data,
we would establish a voluntary submission period whereby facilities can
submit staffing information on a voluntary basis to become familiar
with the system and to provide feedback to CMS on systems issues in
advance of the mandatory submission date.
Comment: We received several comments regarding a phase-in or
postponement of the mandatory submission date. One commenter
recommended calling for a wider-range testing and evaluation period
and/or phase-in of the data collection system. The commenter stated
that this testing period would not only allow a broader spectrum of
providers to gain understanding and familiarity with the process prior
to final implementation, but would add information regarding cost and
burden associated with meeting the submission requirements. For
example, information could be collected on the implementation of
required, but unanticipated system modifications and the potential
investment of additional staff and/or documentation time. Another
commenter suggested CMS phase in the reporting process over time and to
initially only require reporting of the nursing staff and to add other
staff such as therapists at a later time. Another commenter suggested
that as part of CMS's consultation on the submission specifications,
they should include an informal period of ``testing'' that will allow
all providers (not just those who may volunteer for a ``pilot'') the
opportunity to work within the system to determine how it interfaces
with their center's system or to learn how to confidently input the
required data (for those centers unable to automatically upload their
information). The commenter suggested this proposal to provide centers
and CMS a clearer understanding of the burden associated with the
submission requirements. Another commenter stated that contingent on
the outcomes and/or results of the voluntary submission period, CMS
should consider postponement or a phase-in of the intended July 1, 2016
mandatory submission date pending resolution of identified problems or
glitches. The commenter believes that all providers should have the
opportunity to test their respective payroll and time and attendance
processes and gain familiarity with the CMS submission requirements.
The commenter further stated that CMS should again consider a phase-in
or ``grace period'' approach within the planned mandatory reporting
implementation that includes deferral of 5-Star calculation and scoring
for initial submissions. The commenter concluded that, at a minimum,
given the limits of the currently planned data collection system trial,
the allowance for post-submission review and opportunity for correction
should continue for at least the first year of mandatory
implementation.
Response: We are establishing a voluntary submission period
beginning in October 2015. The voluntary submission period will include
a phased approach to registration and training which will allow
facilities to test their submission methods in advance of the July 1,
2016 effective date of the regulation. In order to meet the
requirements of section 6106 of the Affordable Care Act as soon as
possible, we believe that July 1, 2016 is an appropriate start date.
However, we appreciate that in any new, large system of this nature,
implementation challenges may arise and adjustments likely will need to
be made in both the receiving and sending systems. Therefore, we do not
plan to use the results of the reported data in the CMS Five Star
Quality Rating System in CY 2016. During the implementation we plan to
maintain a feedback loop with nursing homes regarding the data
submitted, issues identified, and adjustments made or needed to the
implementation specifications. We also plan to maintain use of the
existing CMS Form 671 annual paper-based form during the initial
implementation so that the results of the traditional and the new
system can inform the learning process.
(7) Submission Schedule
Section 1128I(g)(3) of the Act requires that facilities submit
direct care staffing information on a regular reporting schedule. At
Sec. 483.75(u)(4) we proposed to establish that a facility must submit
direct care staffing information on the schedule specified by CMS, but
no less frequently than quarterly. Comments we received on this topic
and our responses appear elsewhere in this preamble.
(8) Compliance and Enforcement
In the proposed rule we noted that Sec. 483.75(u) would establish
that these new reporting requirements would be conditions a LTC
facility must meet to qualify to participate as a SNF in the Medicare
program or a NF in the Medicaid program. As such, we explained that we
planned to enforce the requirements under this new regulation through
42 CFR part 488 and non-compliance with the proposed Sec. 483.75(u),
could result in CMS or the state imposing one or more remedies
available to address noncompliance with the requirements for LTC
facilities.
The comments we received on this topic, with our responses, appear
below.
Comments: One commenter proposed that if a SNF is found to be non-
compliant with the reporting requirements, there should be an expedited
appeals process afforded to the SNF prior to imposition of a civil
monetary fine or exclusion from a federal healthcare program. Other
commenters stated that it would be more fruitful to lay out specific
sanctions that CMS will impose if a facility fails to comply with the
new reporting requirement. One commenter suggested, for example, that
if a facility fails to provide required staffing data within 30 days of
the deadline, CMS would send a warning letter; if the facility did not
provide the data within 20 days of the warning letter, CMS would levy
daily civil monetary penalties of $X,000 per day starting on the 21st
day after the warning letter; if the facility continued to fail to
provide staffing data at the 40th day following the warning letter, CMS
would institute a hold on new admissions. The commenter stated that
such a sanctioning approach would result in more immediate compliance
and clearer
[[Page 46470]]
expectations for the providers. The commenter further noted that if CMS
or the state determines that a facility has intentionally provided
inaccurate staffing data, the non-compliance should considered a
material false claim to the government for which payment is sought and
damages should be available under the False Claims Act. The commenters
recommended internal audits conducted by CMS, with non-compliance
remedies of a significant downgrading of Five Star Quality Ratings
while the facility is out of compliance, a significant per day Civil
Monetary Penalty, and denial of payment for new admissions until
compliance is achieved. Another commenter noted that, given the
importance of this data, penalties should be imposed when a provider
fails to submit staffing data as required or submits inaccurate or
false data. The commenters recommended a per day Civil Monetary Penalty
at a significant enough level to result in compliance. The commenters
further suggested, a facility's penalty should be posted under
``Staffing'' on Nursing Home Compare so it is easily visible to
consumers and others researching the facility. Still another commenter
stated that they were concerned about the lack of specificity with
regard to remedies for noncompliance and the potential for flexibility,
inconsistency, and lenience that are unfortunately common in
enforcement of other requirements of participation. The commenter noted
that the statement that CMS or the state may impose one or more
remedies underscores our concern--sanctions should be certain.
Moreover, the commenters believe the instructions are ambiguous about
when a deficiency and remedy are triggered. Another commenter urged CMS
to provide greater clarity about how compliance with the proposed
regulation will be determined. One commenter suggested that CMS clarify
the possible enforcement actions that may be considered for aberrant
data.
Response: We appreciate commenters' interest in additional
information regarding how the agency will assess compliance with this
regulation and what specific enforcement actions the agency will pursue
when it identifies noncompliance. Discussion of implementation
specifications and how the agency will apply its enforcement are beyond
the scope of this rulemaking. We will take these comments into account
as we develop guidance at a later date. We note, however, that nothing
in section 1128I(g) of the Act or this final rule establishes that the
staff reporting requirement is a condition of payment.
Comment: One commenter opposed the data collection requirement's
inclusion as a requirement for participation in Medicare, because the
timeline for implementation does not afford all providers the
opportunity to test the CMS system and identify problems that may occur
when interfacing with the facility's software and systems.
Additionally, the commenter noted that CMS has not clearly stated
within the proposed rule how it will determine compliance with the
proposed regulation. Another commenter urged CMS to eliminate the
staffing data collection designation as a requirement of participation,
since such a designation will make compliance subject to the full array
of enforcement actions. The commenter stated that it is premature to
make this collection a requirement of participation since the system
for submission of the staffing data is new and not adequately tested.
Response: As we stated in the proposed rule, we believe that the
inclusion of the staffing data collection as a requirement of
participation is appropriate and desirable, to meet the legislative
goal of greater accountability for LTC facilities, given the importance
of staffing to the quality of care and safety of the nursing home
residents. We further believe that the full array of remedies available
to enforce compliance with other conditions of participation should be
available to enforce this regulation and ensure that the Act's
requirements are met. This regulation is necessary to carry out CMS's
and the state's obligation to ensure compliance with other conditions
of participation (COPs) as specified in the Act. For example, section
1819(b)(4) of the Act includes requirements for staff such as nursing
services, pharmaceutical services, dietary services and other services
facilities are required to provide, and collection of the staffing data
helps verify compliance with these requirements. However, we appreciate
there will be a learning curve as the new reporting system is
implemented. We therefore plan to be careful when assessing compliance
to distinguish between the effects of newness in the initial
implementation and failure to implement the system and ensure accuracy
and adequacy of reporting.
Comment: One commenter remarked that the proposed rule did not
include provisions for adjustment and/or correction to submitted data.
The commenter noted that electronic staffing data submission will serve
to eliminate current inconsistencies and mistakes common to manual
completion of the 671 form, but cited examples of errors were still
possible under an automated system. The commenter stated that automated
payroll systems frequently ``lock down'' once a payroll period ends and
have to be re-entered manually for changes or updates. The commenter
further stated that there can also be occasional clock breakdowns or
clocking oversights, for example, if an individual clocks out, is asked
to stay, but fails to clock back in, all hours worked may not be
captured in real time. The commenter explained that similarly, some
providers have adopted universal worker practices, with those employees
performing, for example, non-nursing or other functions at different
points, again resulting in potential clocking oversights or omissions.
The commenter stated that in any of these circumstances, hours worked
would at least initially be documented somewhere other than the payroll
system and, if identified after a payroll period has closed and/or data
transmission to CMS, adjustment would be required to accurately reflect
staffing and coverage. The commenter believes a defined process should
be incorporated into the collection and reporting system to allow
providers to make documented, verifiable, and auditable data-based
adjustments/corrections to submitted staffing information. The
commenter stated that these adjustments/corrections should be permitted
within the respective quarter to assure accurate documentation and
calculation of staff hours worked and direct care services provided.
Response: We appreciate the commenter's observations about areas of
ongoing data vulnerability and providers' interest in making
corrections when they identify errors with previously submitted data.
We anticipate that our reporting system when fully implemented will
include functionality to submit data corrections. We will address this
issue in further detail through guidance.
(9) Other Comments
Comment: Several commenters requested that CMS provide a written
report on the results of the 2012 Staffing Data Collection Pilot to
providers in advance of finalizing this rule. The commenters stated
that CMS references the 6-month staffing data collection pilot
conducted in 2012 as a strategy component in engaging in ongoing
consultation with all relevant parties and stakeholders; however, no
report regarding the results and outcomes of this pilot has ever been
released for review and feedback by these entities.
[[Page 46471]]
The commenters believe that knowledge of the challenges and successes
that were determined based on this pilot would be very beneficial in
terms of ``lessons learned'', enabling greater understanding of the
requirements being proposed and final implementation of the currently
drafted ``Electronic Staffing Data submission Payroll-based Journal''
(PBJ) system.
Response: As part of our on-going consultation with stakeholders,
we will make information from this project available on the CMS
Staffing Data Submission Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html. However, it
is important to note that this information relates to the
implementation specifications, not the regulatory requirement, and
therefore CMS is proceeding with finalization of the rule at this time
but hopes the data from the project will facilitate dialogue as the
agency develops implementation guidance.
Comment: One commenter stated that further clarification is needed
regarding the voluntary submission process referenced in the preamble
of the proposed rule to be conducted beginning in October 2015. The
commenter stated that it is not clear whether these submissions will be
instead of, or in addition to, the CMS 671 form, and or whether the
information collected during this period will be data of record,
thereby subject to 5-Star Nursing Home Rating System calculations and
potential remedies if noncompliance is determined. The commenter stated
that modifications will have to be made to virtually all homes' payroll
and time and attendance processes to accommodate the provisions of this
rule, and not all homes will be able to begin submission during the
voluntary period to test their own systems against the CMS data
collection process. The commenter noted that again, with the variation
in current payroll and time and attendance systems in nursing homes,
providers must have some margin and flexibility to allow for
unanticipated interface-related problems and need for further
modifications that may occur with the junction of the PBJ and their
respective processes. The commenter stated that the voluntary period
will be the first wide-range, and to their understanding, the only
testing opportunity for the CMS staffing data collection process. The
commenter stated that the goal should be true evaluation and
assessment, with the participating nursing homes not subject to Five-
Star scoring or survey and enforcement actions based only on these
initial preliminary submissions. The commenter stated that if voluntary
submissions are to be considered data of record, at minimum there
should be an accompanying allowance for post submission review as
needed, with opportunity to rectify identified errors,
misinterpretations, or omissions prior to final determinations.
Response: As stated in the preamble of the proposed rule, we intend
to eventually supplant the form CMS-671 and CMS-672, however,
facilities will still be required to complete these until further
notice. Data submitted through the PBJ system during the voluntary
submission period will not have any impact on a facility's Five-Star
rating, or result in any enforcement remedies. Facilities will be
provided with information about their voluntary submissions so they can
make adjustments and be better prepared for the mandatory submission
period. We do not plan on using the results of the reported data in the
Five-Star Quality Rating System calculations in either CY 2015 or CY
2016 in order to accommodate both the voluntary phase and the initial
months of mandatory reporting.
Comment: Several commenters expressed that manually uploaded data
should not be permitted on an ongoing basis. The commenters noted that
CMS should require facilities that want to submit some or all data
manually to request a waiver documenting that they do not have the
capability to report using an automated payroll system. The commenter
stated that CMS should establish a deadline for facilities to have
fully automated data reporting ability to meet the requirements of the
law, after which manual submission would be noncompliant. The commenter
recommended that waiver requests should be time-limited and require an
annual re-application process in which the provider must document the
steps taken to automate its system. Another commenter stated that CMS
must ensure that staffing data come from verifiable, auditable sources
and not self-reporting by facilities.
Response: The requirement in this regulation is for facilities to
submit the data electronically, which facilities will do through the
system we will provide. We note that regardless of whether a facility
uploads their data from a payroll system, or enters it manually, all
facilities are held to the same reporting requirements and standards.
Comment: One commenter remarked that data should be collected in an
all-inclusive and meticulous manner that represents the complete
assessment of care furnished in the SNF setting. The commenter strongly
urged CMS to adhere to the following: (1) Only count staffing data that
represent a complete episode of care from admission to discharge; (2)
CMS should distinguish those cases in which an unexpected readmission
or inpatient hospital stay occurred; and (3) provide feedback reports
to all applicable facilities prior to public reporting and provide an
appropriate timeframe for facilities to dispute any information they
believe is inaccurate. Another commenter requested that CMS clarify how
the data will be analyzed, the benchmark that will be used to define
quality, and the additional uses or actions CMS anticipates as a result
of collecting this data.
Response: We are not entirely clear on some of the commenter's
suggestions and note that some issues raised by this commenter are
outside of the scope of this rulemaking. The data collected under this
regulation will not count episodes of care, but will reflect the staff
in the facility and related average census. Although outside the scope
of this rulemaking, we plan to provide feedback reports to providers
and allow facilities to dispute information they believe to be
inaccurate. In addition, we plan to discuss the uses of the data,
including quality measures, with stakeholders prior to public posting.
Comment: One commenter requested that we eliminate the part-time/
full-time distinction that appears in the Draft PBJ Policy Manual. The
commenter stated that organizations vary in their definitions of part-
time and full- time. The commenter believes in collecting staff hours
worked for the purpose of interpreting staffing levels based on payroll
and related auditable and verifiable data, it is irrelevant whether
coverage is being provided by full or part-time employees.
Response: While this comment is directed at an issue outside the
scope of this regulation, we agree. In response to feedback received,
we have eliminated the part-time/full-time distinction described in the
Draft PBJ Policy Manual.
Comment: One commenter requests that base hourly wage information
be collected as part of this process, which can used to develop a SNF-
specific wage index.
Response: We believe this request is outside of the scope of the
rulemaking. Further, we do not believe that section 1128I(g) of the Act
authorizes us to require the reporting of base hourly wages.
Comment: One commenter stated that in light of the importance of
MDS
[[Page 46472]]
assessment accuracy for QM reporting, payment, and coordination of the
resident care plan across the care continuum, we recommend that duties
related to completion of the RAI be separated out in statistical
reporting job category (RN, LPN, etc.). Licensed staff performing RAI
work cannot be accurately identified in the current proposed structure.
The commenter stated that it is very important that the nurse staffing
data enable consumers and researchers to know who is actually
conducting the RAI. The commenter noted that while the LVN/LPN is
authorized to perform the RAI process and certify its accuracy, an RN
is required to coordinate the RAI process and verify completion (F-278,
Sec. 483.20(h), Coordination: A registered nurse must conduct or
coordinate each assessment with the appropriate participation of health
professionals).
Response: This request relates to the implementation specifications
and is beyond the scope of this rulemaking. As we develop subregulatory
guidance, we will work with stakeholders to consider any additional
types of staff that should be reported separately, including RAI or MDS
Coordinators.
Comment: One commenter strongly recommended against conducting
audits for compliance with this staffing reporting requirement as part
of the survey process, either as regular or focused surveys.
Response: The operations of audits are outside the scope of this
regulation. As a general matter, CMS seeks to ensure that the audits to
assess compliance with reporting requirements are conducted in a manner
that directly addresses the need to verify the data submitted by
facilities. This includes having the audits conducted by individuals or
entities who are subject matter experts in this area.
Comment: One commenter remarked that it is not clear when the
payroll submissions are due (for example, how much time providers will
be given after the end of the quarter to make their submission).
Response: We will communicate information on submission
requirements through guidance. For example, the Draft PBJ Policy Manual
states that providers have 45 days from the end of the quarter to
submit their data. Please see the following Web site for more
information: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html.
Comment: One commenter stated that reports must include the number
and types of nursing staff on each shift, including mutually exclusive
staff categories, in particular RNs versus LPNs. For example, in
reporting staffing, LPNs with administrative duties are not to be
combined with RNs with administrative duties.
Response: The reporting of data is outside the scope of this
regulation. We will work with stakeholders prior to posting information
or formulating quality measures.
Comment: One commenter cautioned that if a facility has low
staffing levels, it would not necessarily equate to poor quality of
care.
Response: While this comment is discussing proposed uses of the
collected data which is outside the scope of this regulation, we agree
that there are many factors that contribute to good quality of care.
Families and residents should not only use a variety of information in
making judgments about a facility (such as the various types of
information available on the CMS Nursing Home Compare Web site), but
above all should visit facilities, talk to residents and staff, and
consult with other knowledgeable parties in the community (such as the
State Survey Agency and the local Nursing Home Ombudsman Program).
Comment: Several commenters expressed support for the
implementation of this rule and CMS' intent to ensure that accurate
staffing data was being reported by LTC facilities.
Response: We thank these commenters for their support.
c. Provisions of the Final Rule
We are adopting the provisions of this final rule as proposed, with
the following changes:
In consideration of public comments, we added a definition
of ``direct care staff'' at Sec. 483.75(u)(1). We renumbered the
subsections within Sec. 483.75(u) accordingly. In addition, we made
conforming changes to utilize the defined term in the provisions
regarding the submission requirements at Sec. 483.75(u)(2)(i) and
(iii) in the final rule and the provision regarding distinguishing
employee from agency and contract staff at Sec. 483.75(u)(3) of this
final rule.
Finally, in consideration of public comment, we added the
adjective ``uniform'' to describe the format requirement in the
provision regarding data format in Sec. 483.75(u)(4) of the final
rule.
IV. Collection of Information Requirements
In the FY 2016 SNF PPS proposed rule (80 FR 22082), we solicited
public comment on that rule's information collection requirements as
they relate to the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501 et seq.). However, of all of the comments received on the proposed
rule, only one was related to our position that all of the proposed
information collection requirements were exempt from the PRA. A summary
of the comment and our response follows.
Consistent with the proposed rule, this final rule maintains that
the information collection requirements are exempt from the PRA. We
refer readers to the FY 2016 SNF PPS proposed rule for details.
Comment: One commenter disagreed with CMS's assertion that the PRA
does not apply to the proposed staff reporting requirements. The
commenter further stated that because the Affordable Care Act, not OBRA
1987, was the statute that established the staff reporting
requirements, the requirements would likely not fall within the scope
of OBRA 1987's PRA waivers.
Response: We respectfully disagree with the commenter's analysis.
The staff reporting requirements are exempt from PRA because section
6106 of the Affordable Care Act (which added 1128I(g) of the Act) is
related to the information required for the purposes of carrying out
relevant sections of OBRA 1987's nursing home reform requirements. For
example, section 1819(b)(4) of the Act includes requirements for staff
such as nursing services, pharmaceutical services, dietary services,
and other services facilities are required to provide, and the
collection of the staffing data helps verify compliance with these
requirements.
V. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
We have examined the impacts of this final 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), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is
[[Page 46473]]
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.
2. Statement of Need
This final rule would update the SNF prospective payment rates for
FY 2015 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 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. In addition, this final
rule specifies a SNF all-cause all-condition hospital readmission
measure, as well as adopts that measure for a new SNF VBP Program, and
includes a discussion of SNF VBP Program policies we are considering
for future rulemaking to promote higher quality and more efficient
health care for Medicare beneficiaries. This final rule also implements
a new quality reporting program for SNFs, as specified in the IMPACT
Act. Finally, through this final rule, we are implementing section
1128I(g) of the Act, which requires the electronic submission of
staffing information based on payroll and other verifiable and
auditable data.
3. Overall Impacts
This final rule sets forth updates of the SNF PPS rates contained
in the SNF PPS final rule for FY 2015 (79 FR 45628). Based on the
above, we estimate that the aggregate impact would be an increase of
$430 million in payments to SNFs, resulting from the SNF market basket
update to the payment rates, as adjusted by the applicable forecast
error adjustment and by the MFP adjustment. The impact analysis of this
final rule represents the projected effects of the changes in the SNF
PPS from FY 2015 to FY 2016. Although the best data available are
utilized, there is no attempt to predict behavioral responses to these
changes, or to make adjustments for future changes in such variables as
days or case-mix.
Certain 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 certain events that may occur
within the assessed impact time period. Some examples of possible
events may include newly-legislated general Medicare program funding
changes by the Congress, or changes specifically related to SNFs. In
addition, changes to the Medicare program may continue to be made as a
result of previously-enacted legislation, or new statutory provisions.
Although these changes may not be specific to the SNF PPS, the nature
of the Medicare program is such that the changes may interact and,
thus, the complexity of the interaction of these changes could make it
difficult to predict accurately the full scope of the impact upon SNFs.
In accordance with sections 1888(e)(4)(E) and 1888(e)(5) of the
Act, we update the FY 2015 payment rates by a factor equal to the
market basket index percentage change adjusted by the FY 2014 forecast
error and the MFP adjustment to determine the payment rates for FY
2016. As discussed previously, for FY 2012 and each subsequent FY, as
required by section 1888(e)(5)(B) of the Act as amended by section
3401(b) of the Affordable Care Act, the market basket percentage is
reduced by the MFP adjustment. The special AIDS add-on established by
section 511 of the MMA remains in effect until such date as the
Secretary certifies that there is an appropriate adjustment in the case
mix. We have not provided a separate impact analysis for the MMA
provision. Our latest estimates indicate that there are fewer than
4,800 beneficiaries who qualify for the add-on payment for residents
with AIDS. The impact to Medicare is included in the total column of
Table 12. In updating the SNF PPS rates for FY 2016, we made a number
of standard annual revisions and clarifications mentioned elsewhere in
this final 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 final rule applies to SNF PPS
payments in FY 2016. Accordingly, the analysis that follows only
describes the impact of this single year. In accordance with the
requirements of the Act, we will publish a notice or rule for each
subsequent FY that will provide for an update to the SNF PPS payment
rates and include an associated impact analysis.
In accordance with sections 1888(g) and (h)(2)(A) of the Act, we
are finalizing the adoption of a SNF 30-Day All-Cause Readmission
Measure (SNFRM) for the SNF VBP Program. Because this measure is
claims-based, its adoption under the SNF VBP Program would not result
in any increased costs to SNFs.
However, we do not yet have preliminary data with which we could
project economic impacts associated with the measure. We intend to make
additional proposals for the SNF VBP Program in future rulemaking, and
we will assess the impacts of the SNFRM and any associated SNF VBP
Program proposals at that time.
The burden associated with the SNF QRP is the time and effort
associated with data collection and reporting. In this final rule, we
are finalizing three quality measures that meet the requirements of
section 1888(e)(6)(B)(II) of the Act.
Our burden calculations take into account all ``new'' items
required on the MDS 3.0 to support data collection and reporting for
these three finalized measures. New items will be included on the
following assessments: SNF PPS 5-Day, Swing Bed PPS 5-Day, OMRA--Start
of Therapy Discharge, OMRA--Other Discharge, OBRA Discharge, Swing Bed
OMRA--Start of Therapy Discharge, Swing Bed OMRA--Other Discharge, and
Swing Bed Discharge on the MDS 3.0. The SNF QRP also requires the
addition of a SNF PPS Part A Discharge Assessment, which will also
include new items. New items include data elements required to identify
whether pressure ulcers were present on admission, to inform future
development of the Percent of Residents or Patients with Pressure
Ulcers That Are New or Worsened (Short Stay) (NQF #0678), as well as
changes in function and occurrence of falls with major injury. To the
extent applicable, we will use standardized items to collect data for
the three measures. For a copy of the data collection instrument,
please visit: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/SNF-Quality-Reporting-Program-Measures-and-Technical-Information.html.
We estimate a total additional burden of $30.00 per Medicare-
covered SNF stay, based on the most recent data available, in this case
FY 2014, that 15,421 SNFs had a total of 2,599,656 Medicare-covered
stays for fee-for-service beneficiaries. This would equate
[[Page 46474]]
to 1,112,002.85 total added hours or 72.11 hours per SNF annually.
We anticipate that the additional MDS items we finalized will be
completed by Registered Nurses (RN), Occupational Therapists (OT), and/
or Physical Therapists (PT), depending on the item. We identified the
staff type per item based on past LTCH and IRF burden calculations in
conjunction with expert opinion. Our assumptions for staff type were
based on the categories generally necessary to perform assessment:
Registered Nurse (RN), Occupational Therapy (OT), and Physical Therapy
(PT). Individual providers determine the staffing resources necessary,
therefore, we averaged the national average for these labor types and
established a composite cost estimate. We obtained mean hourly wages
for these staff from the U.S. Bureau of Labor Statistics' May 2013
National Occupational Employment and Wage Estimates (https://www.bls.gov/oes/current/oes_nat.htm), and to account for overhead and
fringe benefits, we have doubled the mean hourly wage. The mean hourly
wage for an RN is $33.13, doubled to $66.26 to account for overhead and
fringe benefits. The mean hourly wage for an OT is $37.45, doubled to
$74.90 to account for overhead and fringe benefits. The mean hourly
wage for a PT is $39.51, doubled to $79.02 to account for overhead and
fringe benefits.
To calculate the added burden, we first identified the total number
of new items to be added into assessment instruments. We assume that
each new item accounts for 0.5 minutes of nursing facility staff time.
This assumption is consistent with burden calculations in past IRF and
LTCH federal regulations. For each staff type, we then multiply the
added burden in minutes with the number of times we believe that each
item will be completed annually. To identify the number of times an
item would be completed annually, we noted the number of total SNF FFS
Medicare-covered stays in FY 2014, the most recent data available to
us. We assume that if an item were added to all discharge assessments,
then that item would be completed at least one time per SNF FFS
Medicare-covered stay. For example, the time it takes to complete an
item added to all discharge assessments (0.5 minutes) would be
multiplied by the number of SNF FFS Medicare-covered stays in FY 2014
to identify the total added burden in minutes associated with that
item. Items added only to the SNF PPS Part A Discharge were weighted to
reflect the proportion of SNF stays for residents who switch payers,
but are not physically discharged from the facility. Added burden in
minutes per staff type was then converted to hours and multiplied by
the doubled hourly wage to identify the annual cost per staff type.
Given these wages and time estimates, the total cost related to the SNF
PPS Part A Discharge Assessment and SNF QRP measures is estimated at
$5,057.45 per SNF annually, or $78,011,166.25 for all SNFs annually. We
received comments regarding the burden related to the SNF QRP, which we
addressed in section III.D.3.g.(2). of this final rule.
We have also conducted an impact analysis with regard to the
electronic submission of staffing information, which will be required
under 42 CFR 483.75(u). While facilities have been reporting their
staffing data for many years via an annual, paper-based system, we
appreciate that the electronic submission of staffing data is something
that facilities have not been required to do and that this new
requirement will have financial and/or staff time implications. Like
the implementation of many new programs, the level of effort will be
higher upfront, but decline throughout subsequent years.
4. Detailed Economic Analysis
The FY 2016 SNF PPS payment impacts appear in Table 12. Using the
most recently available data, in this case FY 2014, we apply the
current FY 2015 wage index and labor-related share value to the number
of payment days to simulate FY 2015 payments. Then, using the same FY
2014 data, we apply the FY 2016 wage index and labor-related share
value to simulate FY 2016 payments. We tabulate the resulting payments
according to the classifications in Table 12 (for example, facility
type, geographic region, facility ownership), and compare the simulated
FY 2015 payments to the simulated FY 2016 payments to determine the
overall impact. The breakdown of the various categories of data in the
table 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 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 zero percent; however,
there are distributional effects of the change.
The fourth column shows the effect of all of the changes on the FY
2016 payments. The update of 1.2 percent (consisting of the market
basket increase of 2.3 percentage points, reduced by the 0.6 percentage
point forecast error adjustment and further reduced by the 0.5
percentage point MFP adjustment) 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 1.2 percent,
assuming facilities do not change their care delivery and billing
practices in response.
As illustrated in Table 12, the combined effects of all of the
changes vary by specific types of providers and by location. For
example, due to changes finalized in this rule, providers in the rural
Pacific region would experience a 1.4 percent increase in FY 2016 total
payments.
Table 12--Projected Impact to the SNF PPS for FY 2016
----------------------------------------------------------------------------------------------------------------
Number of
facilities FY Update wage Total change
2016 data (%) (%)
----------------------------------------------------------------------------------------------------------------
Group:
Total....................................................... 15,425 0.0 1.2
Urban....................................................... 10,888 0.1 1.3
Rural....................................................... 4,537 -0.6 0.6
Hospital based urban........................................ 546 0.2 1.4
Freestanding urban.......................................... 10,342 0.1 1.3
[[Page 46475]]
Hospital based rural........................................ 627 -0.6 0.6
Freestanding rural.......................................... 3,910 -0.6 0.6
Urban by region:
New England................................................. 801 0.5 1.7
Middle Atlantic............................................. 1,485 0.6 1.8
South Atlantic.............................................. 1,853 -0.2 1.0
East North Central.......................................... 2,068 -0.1 1.1
East South Central.......................................... 544 0.0 1.2
West North Central.......................................... 899 -0.5 0.6
West South Central.......................................... 1,310 -0.1 1.1
Mountain.................................................... 501 -0.4 0.8
Pacific..................................................... 1,420 0.6 1.8
Outlying.................................................... 7 -1.1 0.1
Rural by region:
New England................................................. 142 -0.9 0.3
Middle Atlantic............................................. 222 -1.4 -0.3
South Atlantic.............................................. 511 -0.1 1.1
East North Central.......................................... 937 -0.1 1.1
East South Central.......................................... 535 -0.5 0.7
West North Central.......................................... 1,089 -0.9 0.3
West South Central.......................................... 765 -1.3 -0.1
Mountain.................................................... 233 -0.8 0.4
Pacific..................................................... 103 0.2 1.4
Ownership:
Government.................................................. 882 0.0 1.2
Profit...................................................... 10,862 0.0 1.2
Non-profit.................................................. 3,681 -0.1 1.1
----------------------------------------------------------------------------------------------------------------
Note: The Total column includes the 2.3 percent market basket increase, reduced by the 0.6 percentage point
forecast error adjustment and further reduced by the 0.5 percentage point MFP adjustment. Additionally, we
found no SNFs in rural outlying areas.
We have also conducted an economic analysis with regard impact of
the electronic submission of staffing information, which is required
under 42 CFR 483.75(u). Factors affecting a facility's cost include the
size of the facility, the number of employees of a facility, and the
type of system a facility uses to report and submit data. To calculate
the cost, we analyzed information from a staffing pilot conducted in
2012, including evaluating the type (for example, hours per day) and
frequency (for example, quarterly) of the information to be submitted.
For example, we estimate that a facility using a complex, automated
payroll or time-keeping system would require some upfront and ongoing
costs to configure their system to provide the data. We estimate these
costs to be approximately $500 to $1,500 upfront, with an additional
$500 to $1,500 in maintenance costs each year. Additionally, we
estimate this type of facility would require an estimated 1 hour of in-
house staff time per week, to oversee the process. Conversely, a
facility without an automated time-keeping system would not have the
upfront and ongoing costs associated with purchasing or configuring a
system. However, this facility would require more time from in-house
staff to enter and submit the data. We estimate this time to be
approximately 4 hours per week. To help mitigate potential cost for
facilities, we will be providing a system for facilities to enter and
submit data manually and at no cost. Using the 2013 hourly wage
estimate of $18.71 per hour for payroll and timekeeping employees in
Skilled Nursing Facilities from the Bureau of Labor Statistics, we
believe that the cost to facilities will range between $4,100 and
$6,800 per facility for the first year of implementation. This includes
one-time costs associated with configuring payroll or time-keeping
systems to produce and submit the required data. Subsequent years would
have lower costs ranging from $2,700 to $4,200 per facility per year.
These estimates also include up to 16 hours per year for training staff
on the submission of data.
5. Alternatives Considered
As described in this section, we estimate that the aggregate impact
for FY 2016 would be an increase of $430 million in payments to SNFs,
resulting from the SNF market basket update to the payment rates, as
adjusted by the applicable forecast error adjustment and by the MFP
adjustment.
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 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 the
payment methodology as discussed previously.
Section 1128I(g) of the Act establishes requirement for LTC
facilities to submit direct care staffing information. This section of
the statute specifically prescribes the data to be submitted.
Accordingly we are not pursuing alternatives to the reporting
requirement as discussed previously.
[[Page 46476]]
6. Accounting Statement
As required by OMB Circular A-4 (available online at
www.whitehouse.gov/sites/default/files/omb/assets/regulatory_matters_pdf/a-4.pdf), in Table 13, we have prepared an
accounting statement showing the classification of the expenditures
associated with the provisions of this final rule. Table 13 provides
our best estimate of the possible changes in Medicare payments under
the SNF PPS as a result of the policies in this final rule, based on
the data for 15,425 SNFs in our database. All expenditures are
classified as transfers to Medicare providers (that is, SNFs).
Table 13--Accounting Statement: Classification of Estimated
Expenditures, From the 2015 SNF PPS FY to the 2016 SNF PPS FY
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
Annualized Monetized Transfers............ $430 million. *
From Whom To Whom? Federal Government to SNF
Medicare Providers.
------------------------------------------------------------------------
* The net increase of $430 million in transfer payments is a result of
the forecast error and MFP adjusted market basket increase of $430
million.
7. Conclusion
This final rule sets forth updates of the SNF PPS rates contained
in the SNF PPS final rule for FY 2015 (79 FR 45628). Based on the
above, we estimate the overall estimated payments for SNFs in FY 2016
are projected to increase by $430 million, or 1.2 percent, compared
with those in FY 2015. We estimate that in FY 2016 under RUG-IV, SNFs
in urban and rural areas would experience, on average, a 1.3 and 0.6
percent increase, respectively, in estimated payments compared with FY
2015. Providers in the urban Pacific and Middle Atlantic regions would
experience the largest estimated increase in payments of approximately
1.8 percent. Providers in the rural Middle Atlantic region would
experience a small decrease in payments of 0.3 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, we estimate
approximately 91 percent of SNFs are considered small businesses
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 Web site at
https://www.sba.gov/category/navigation-structure/contracting/contracting-officials/eligibility-size-standards). In addition,
approximately 25 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 final rule sets forth updates of the SNF PPS rates contained
in the SNF PPS final rule for FY 2015 (79 FR 45628). Based on the
above, we estimate that the aggregate impact would be an increase of
$430 million in payments to SNFs, resulting from the SNF market basket
update to the payment rates, as adjusted by the MFP adjustment and
forecast error adjustment. While it is projected in Table 12 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 2016 wage indexes 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. According to MedPAC, Medicare covers
approximately 12 percent of total patient days in freestanding
facilities and 22 percent of facility revenue (Report to the Congress:
Medicare Payment Policy, March 2015, available at https://medpac.gov/documents/reports/chapter-8-skilled-nursing-facility-services-(march-
2015-report).pdf). However, it is worth noting that the distribution of
days and payments is highly variable. That is, the majority of SNFs
have significantly lower Medicare utilization (Report to the Congress:
Medicare Payment Policy, March 2015, available at https://medpac.gov/documents/reports/chapter-8-skilled-nursing-facility-services-(march-
2015-report).pdf). 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 12. As indicated in Table 12, the effect on facilities is
projected to be an aggregate positive impact of 1.2 percent. 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 final rule will not
have a significant impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. This final 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 would be similar to the impact
on SNF providers overall. Moreover, as noted in previous SNF PPS final
rules (most recently the one for FY 2015 (79 FR 45658)), the category
of small rural hospitals would be included within the analysis of the
impact of this final rule on small entities in general. As indicated in
Table 12, the effect on facilities is projected to be an aggregate
positive impact of 1.2 percent. As the overall 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.
C. Unfunded Mandates Reform Act Analysis
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2015, that
threshold is approximately $144 million. This final rule would not
impose spending costs on state, local, or tribal governments in the
aggregate, or by the private sector, of $144 million.
[[Page 46477]]
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 final rule will have no substantial direct effect on
state and local governments, preempt state law, or otherwise have
federalism implications.
E. Congressional Review Act
This final 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.
In accordance with the provisions of Executive Order 12866, this
final rule was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 483
Grant programs-health, Health facilities, Health professions,
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting
and recordkeeping requirements, Safety.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
0
1. The authority citation for part 483 is revised to read as follows:
Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social
Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).
0
2. Section 483.75 is amended by adding paragraph (u) to read as
follows:
Sec. 483.75 Administration.
* * * * *
(u) Mandatory submission of staffing information based on payroll
data in a uniform format. Long-term care facilities must electronically
submit to CMS complete and accurate direct care staffing information,
including information for agency and contract staff, based on payroll
and other verifiable and auditable data in a uniform format according
to specifications established by CMS.
(1) Direct Care Staff. Direct Care Staff are those individuals who,
through interpersonal contact with residents or resident care
management, provide care and services to allow residents to attain or
maintain the highest practicable physical, mental, and psychosocial
well-being. Direct care staff does not include individuals whose
primary duty is maintaining the physical environment of the long term
care facility (for example, housekeeping).
(2) Submission requirements. The facility must electronically
submit to CMS complete and accurate direct care staffing information,
including the following:
(i) The category of work for each person on direct care staff
(including, but not limited to, whether the individual is a registered
nurse, licensed practical nurse, licensed vocational nurse, certified
nursing assistant, therapist, or other type of medical personnel as
specified by CMS);
(ii) Resident census data; and
(iii) Information on direct care staff turnover and tenure, and on
the hours of care provided by each category of staff per resident per
day (including, but not limited to, start date, end date (as
applicable), and hours worked for each individual).
(3) Distinguishing employee from agency and contract staff. When
reporting information about direct care staff, the facility must
specify whether the individual is an employee of the facility, or is
engaged by the facility under contract or through an agency.
(4) Data format. The facility must submit direct care staffing
information in the uniform format specified by CMS.
(5) Submission schedule. The facility must submit direct care
staffing information on the schedule specified by CMS, but no less
frequently than quarterly.
Dated: July 27, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: July 28, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-18950 Filed 7-30-15; 4:15 pm]
BILLING CODE 4120-01-P
