Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2014, 47859-47934 [2013-18770]
Download as PDF
Vol. 78
Tuesday,
No. 151
August 6, 2013
Part III
Department of Health and Human Services
tkelley on DSK3SPTVN1PROD with RULES2
Centers for Medicare & Medicaid Services
42 CFR Part 412
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment
System for Federal Fiscal Year 2014; Rules
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
PO 00000
Frm 00001
Fmt 4717
Sfmt 4717
E:\FR\FM\06AUR2.SGM
06AUR2
47860
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 412
[CMS–1448–F]
RIN 0938–AR66
Medicare Program; Inpatient
Rehabilitation Facility Prospective
Payment System for Federal Fiscal
Year 2014
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
This final rule updates the
prospective payment rates for inpatient
rehabilitation facilities (IRFs) for federal
fiscal year (FY) 2014 (for discharges
occurring on or after October 1, 2013
and on or before September 30, 2014) as
required by the statute. This final rule
also revised the list of diagnosis codes
that may be counted toward an IRF’s
‘‘60 percent rule’’ compliance
calculation to determine ‘‘presumptive
compliance,’’ update the IRF facilitylevel adjustment factors using an
enhanced estimation methodology,
revise sections of the Inpatient
Rehabilitation Facility-Patient
Assessment Instrument, revise
requirements for acute care hospitals
that have IRF units, clarify the IRF
regulation text regarding limitation of
review, update references to previously
changed sections in the regulations text,
and revise and update quality measures
and reporting requirements under the
IRF quality reporting program.
DATES: Effective Dates: The regulatory
amendments in this rule are effective
SUMMARY:
October 1, 2013, except for the
amendment to § 412.25 which is
effective October 1, 2014.
Applicability Dates: The revisions to
the list of diagnosis codes that are used
to determine presumptive compliance
under the ‘‘60 percent rule’’ are
applicable for compliance review
periods beginning on or after October 1,
2014. The updated IRF prospective
payment rates are applicable for IRF
discharges occurring on or after October
1, 2013 and on or before September 30,
2014 (FY 2014). The changes to the
Inpatient Rehabilitation Facility-Patient
Assessment Instrument, the
amendments to § 412.25, and the
revised and updated quality measures
and reporting requirements under the
IRF quality reporting program are
applicable for IRF discharges occurring
on or after October 1, 2014.
FOR FURTHER INFORMATION CONTACT:
Gwendolyn Johnson, (410) 786–6954,
for general information.
Caroline Gallaher, (410) 786–8705, for
information about the quality reporting
program.
Susanne Seagrave, (410) 786–0044 or
Kadie Thomas, (410) 786–0468, for
information about the payment policies
and the proposed payment rates.
SUPPLEMENTARY INFORMATION: The IRF
PPS Addenda along with other
supporting documents and tables
referenced in this final rule are available
through the Internet on the CMS Web
site at https://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/.
facilities (IRFs) for federal fiscal year
(FY) 2014 (that is, for discharges
occurring on or after October 1, 2013
and on or before September 30, 2014) as
required under section 1886(j)(3)(C) of
the Social Security Act (the Act).
Section 1886(j)(5) of the Act requires the
Secretary to publish in the Federal
Register on or before the August 1 that
precedes the start of each fiscal year, the
classification and weighting factors for
the IRF prospective payment system’s
(PPS) case-mix groups and a description
of the methodology and data used in
computing the prospective payment
rates for that fiscal year.
B. Summary of Major Provisions
A. Purpose
In this final rule, we use the methods
described in the July 30, 2012 FY 2013
IRF PPS notice (77 FR 44618) to update
the federal prospective payment rates
for FY 2014 using updated FY 2012 IRF
claims and the most recent available IRF
cost report data. We are also revising the
list of diagnosis codes that are used to
determine presumptive compliance
under the ‘‘60 percent rule,’’ updating
the IRF facility-level adjustment factors
using an enhanced estimation
methodology, revising sections of the
Inpatient Rehabilitation Facility-Patient
Assessment Instrument, revising
requirements for acute care hospitals
that have IRF units, clarifying the IRF
regulation text regarding limitation of
review, updating references to
previously changed sections in the
regulations text, and revising and
updating quality measures and reporting
requirements under the IRF quality
reporting program.
This final rule updates the payment
rates for inpatient rehabilitation
C. Summary of Costs, Benefits and
Transfers
Executive Summary
Transfers
FY 2014 IRF PPS payment rate update ............
Refinements to the presumptive compliance
method under the ‘60 percent rule’.
The overall economic impact of this final rule is an estimated $170 million in increased payments from the Federal government to IRFs during FY 2014.
The estimated FY 2015 impact of the refinements to the presumptive compliance method reflects a decrease of payments between $0 to $520 million, depending on the IRFs’ behavioral responses to the changes, with $520 million representing the upper bound.
Provision description
Costs
New quality reporting program requirements .....
tkelley on DSK3SPTVN1PROD with RULES2
Provision
description
The total costs in FY 2015 for IRFs as a result of the new quality reporting requirements are
estimated to be $9.2 million.
To assist readers in referencing
sections contained in this document, we
are providing the following Table of
Contents..
Table of Contents
I. Background
VerDate Mar<15>2010
21:13 Aug 05, 2013
Jkt 229001
A. Historical Overview of the Inpatient
Rehabilitation Facility Prospective
Payment System (IRF PPS)
B. Provisions of the Affordable Care Act
Affecting the IRF PPS in FY 2012 and
Beyond
C. Operational Overview of the Current IRF
PPS
PO 00000
Frm 00002
Fmt 4701
Sfmt 4700
II. Summary of Provisions of the Proposed
Rule
A. Proposed Updates to the IRF Federal
Prospective Payment Rates for Federal
Fiscal Year (FY) 2014
B. Proposed Revisions to Existing
Regulation Text
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
III. Analysis and Responses to Public
Comments
IV. Update to the Case-Mix Group (CMG)
Relative Weights and Average Length of
Stay Values for FY 2014
V. Updates to the Facility-Level Adjustment
Factors for FY 2014
A. Background on Facility-Level
Adjustments
B. Updates to the IRF Facility-Level
Adjustment Factors
C. Budget Neutrality Methodology for the
Updates to the IRF Facility-Level
Adjustment Factors
VI. FY 2014 IRF PPS Federal Prospective
Payment Rates
A. Market Basket Increase Factor,
Productivity Adjustment, and Other
Adjustment for FY 2014
B. Secretary’s Final Recommendation
C. Labor-Related Share for FY 2014
D. Wage Adjustment
E. Description of the IRF Standard
Conversion Factor and Payment Rates for
FY 2014
F. Example of the Methodology for
Adjusting the Federal Prospective
Payment Rates
VII. Update to Payments for High-Cost
Outliers Under the IRF PPS
A. Update to the Outlier Threshold
Amount for FY 2014
B. Update to the IRF Cost-to-Charge Ratio
Ceiling and Urban/Rural Averages
VIII. Refinements to the Presumptive
Compliance Methodology
A. Background on the Compliance
Percentage
B. Changes to the ICD–9–CM Codes That
Are Used To Determine Presumptive
Compliance
IX. Non-Quality Related Revisions to IRF–
PAI Sections
A. Updates
B. Additions
C. Deletions
D. Changes
X. Technical Corrections to the Regulations
at § 412.130
XI. Revisions to the Conditions of Payment
for IRF Units Under the IRF PPS
XII. Clarification of the Regulations at
§ 412.630
XIII. Revision to the Regulations at § 412.29
XIV. Revisions and Updates to the Quality
Reporting Program for IRFs
A. Background and Statutory Authority
B. Quality Measures Previously Finalized
and Currently in Use for the IRF Quality
Reporting Program
C. New IRF QRP Quality Measures
Affecting the FY 2016 and FY 2017 IRF
PPS Annual Increase Factor, and
Subsequent Year Increase Factors
D. Changes to the IRF–PAI That Are
Related to the IRF Quality Reporting
Program
E. Change in Data Collection and
Submission Periods for Future Program
Years
F. Reconsideration and Appeals Process
G. Policy for Granting of a Waiver of the
IRF QRP Data Submission Requirements
in Case of Disaster or Extraordinary
Circumstances
H. Public Display of Data Quality Measures
for the IRF QRP Program
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
I. Method for Applying the Reduction to
the FY 2014 IRF Increase Factor for IRFs
That Fail To Meet the Quality Reporting
Requirements
XV. Miscellaneous Comments
XVI. Provisions of the Final Regulations
A. Payment Provision Changes
B. Revisions to Existing Regulation Text
XVII. Collection of Information Requirements
A. ICRs Regarding IRF QRP
B. ICRs Regarding Non-Quality Related
Changes to the IRF–PAI
XVIII. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impacts
C. Detailed Economic Analysis
D. Alternatives Considered
E. Accounting Statement
F. Conclusion
Regulation Text
I. Background
A. Historical Overview of the Inpatient
Rehabilitation Facility Prospective
Payment System (IRF PPS)
Section 1886(j) of the Act provides for
the implementation of a per-discharge
prospective payment system (PPS) for
inpatient rehabilitation hospitals and
inpatient rehabilitation units of a
hospital (hereinafter referred to as IRFs).
Payments under the IRF PPS
encompass inpatient operating and
capital costs of furnishing covered
rehabilitation services (that is, routine,
ancillary, and capital costs), but not
direct graduate medical education costs,
costs of approved nursing and allied
health education activities, bad debts,
and other services or items outside the
scope of the IRF PPS. Although a
complete discussion of the IRF PPS
provisions appears in the original FY
2002 IRF PPS final rule (66 FR 41316)
and the FY 2006 IRF PPS final rule (70
FR 47880), we are providing below a
general description of the IRF PPS for
fiscal years (FYs) 2002 through 2013.
Under the IRF PPS from FY 2002
through FY 2005, as described in the FY
2002 IRF PPS final rule (66 FR 41316),
the federal prospective payment rates
were computed across 100 distinct casemix groups (CMGs). We constructed 95
CMGs using rehabilitation impairment
categories (RICs), functional status (both
motor and cognitive), and age (in some
cases, cognitive status and age may not
be a factor in defining a CMG). In
addition, we constructed five special
CMGs to account for very short stays
and for patients who expire in the IRF.
For each of the CMGs, we developed
relative weighting factors to account for
a patient’s clinical characteristics and
expected resource needs. Thus, the
weighting factors accounted for the
relative difference in resource use across
all CMGs. Within each CMG, we created
tiers based on the estimated effects that
PO 00000
Frm 00003
Fmt 4701
Sfmt 4700
47861
certain comorbidities would have on
resource use.
We established the federal PPS rates
using a standardized payment
conversion factor (formerly referred to
as the budget-neutral conversion factor).
For a detailed discussion of the budgetneutral conversion factor, please refer to
our FY 2004 IRF PPS final rule (68 FR
45684 through 45685). In the FY 2006
IRF PPS final rule (70 FR 47880), we
discussed in detail the methodology for
determining the standard payment
conversion factor.
We applied the relative weighting
factors to the standard payment
conversion factor to compute the
unadjusted federal prospective payment
rates under the IRF PPS from FYs 2002
through 2005. Within the structure of
the payment system, we then made
adjustments to account for interrupted
stays, transfers, short stays, and deaths.
Finally, we applied the applicable
adjustments to account for geographic
variations in wages (wage index), the
percentage of low-income patients,
location in a rural area (if applicable),
and outlier payments (if applicable) to
the IRF’s unadjusted federal prospective
payment rates.
For cost reporting periods that began
on or after January 1, 2002 and before
October 1, 2002, we determined the
final prospective payment amounts
using the transition methodology
prescribed in section 1886(j)(1) of the
Act. Under this provision, IRFs
transitioning into the PPS were paid a
blend of the federal IRF PPS rate and the
payment that the IRF would have
received had the IRF PPS not been
implemented. This provision also
allowed IRFs to elect to bypass this
blended payment and immediately be
paid 100 percent of the federal IRF PPS
rate. The transition methodology
expired as of cost reporting periods
beginning on or after October 1, 2002
(FY 2003), and payments for all IRFs
now consist of 100 percent of the federal
IRF PPS rate.
We established a CMS Web site as a
primary information resource for the
IRF PPS. The Web site is: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
InpatientRehabFacPPS/. The
Web site may be accessed to download
or view publications, software, data
specifications, educational materials,
and other information pertinent to the
IRF PPS.
Section 1886(j) of the Act confers
broad statutory authority upon the
Secretary to propose refinements to the
IRF PPS. In the FY 2006 IRF PPS final
rule (70 FR 47880) and in correcting
amendments to the FY 2006 IRF PPS
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47862
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
final rule (70 FR 57166) that we
published on September 30, 2005, we
finalized a number of refinements to the
IRF PPS case-mix classification system
(the CMGs and the corresponding
relative weights) and the case-level and
facility-level adjustments. These
refinements included the adoption of
the Office of Management and Budget’s
(OMB) Core-Based Statistical Area
(CBSA) market definitions,
modifications to the CMGs, tier
comorbidities, and CMG relative
weights, implementation of a new
teaching status adjustment for IRFs,
revision and rebasing of the market
basket index used to update IRF
payments, and updates to the rural, lowincome percentage (LIP), and high-cost
outlier adjustments. Beginning with the
FY 2006 IRF PPS final rule (70 FR 47908
through 47917), the market basket index
used to update IRF payments is a market
basket reflecting the operating and
capital cost structures for freestanding
IRFs, freestanding inpatient psychiatric
facilities (IPFs), and long-term care
hospitals (LTCHs) (hereafter referred to
as the rehabilitation, psychiatric, and
long-term care (RPL) market basket).
Any reference to the FY 2006 IRF PPS
final rule in this final rule also includes
the provisions effective in the correcting
amendments. For a detailed discussion
of the final key policy changes for FY
2006, please refer to the FY 2006 IRF
PPS final rule (70 FR 47880 and 70 FR
57166).
In the FY 2007 IRF PPS final rule (71
FR 48354), we further refined the IRF
PPS case-mix classification system (the
CMG relative weights) and the caselevel adjustments, to ensure that IRF
PPS payments would continue to reflect
as accurately as possible the costs of
care. For a detailed discussion of the FY
2007 policy revisions, please refer to the
FY 2007 IRF PPS final rule (71 FR
48354).
In the FY 2008 IRF PPS final rule (72
FR 44284), we updated the federal
prospective payment rates and the
outlier threshold, revised the IRF wage
index policy, and clarified how we
determine high-cost outlier payments
for transfer cases. For more information
on the policy changes implemented for
FY 2008, please refer to the FY 2008 IRF
PPS final rule (72 FR 44284), in which
we published the final FY 2008 IRF
federal prospective payment rates.
After publication of the FY 2008 IRF
PPS final rule (72 FR 44284), section
115 of the Medicare, Medicaid, and
SCHIP Extension Act of 2007 (Pub. L.
110–173, enacted on December 29,
2007) (MMSEA), amended section
1886(j)(3)(C) of the Act to apply a zero
percent increase factor for FYs 2008 and
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
2009, effective for IRF discharges
occurring on or after April 1, 2008.
Section 1886(j)(3)(C) of the Act required
the Secretary to develop an increase
factor to update the IRF federal
prospective payment rates for each FY.
Based on the legislative change to the
increase factor, we revised the FY 2008
federal prospective payment rates for
IRF discharges occurring on or after
April 1, 2008. Thus, the final FY 2008
IRF federal prospective payment rates
that were published in the FY 2008 IRF
PPS final rule (72 FR 44284) were
effective for discharges occurring on or
after October 1, 2007 and on or before
March 31, 2008; and the revised FY
2008 IRF federal prospective payment
rates were effective for discharges
occurring on or after April 1, 2008 and
on or before September 30, 2008. The
revised FY 2008 federal prospective
payment rates are available on the CMS
Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/DataFiles.html.
In the FY 2009 IRF PPS final rule (73
FR 46370), we updated the CMG relative
weights, the average length of stay
values, and the outlier threshold;
clarified IRF wage index policies
regarding the treatment of ‘‘New
England deemed’’ counties and multicampus hospitals; and revised the
regulation text in response to section
115 of the MMSEA to set the IRF
compliance percentage at 60 percent
(the ‘‘60 percent rule’’) and continue the
practice of including comorbidities in
the calculation of compliance
percentages. We also applied a zero
percent market basket increase factor for
FY 2009 in accordance with section 115
of the MMSEA. For more information on
the policy changes implemented for FY
2009, please refer to the FY 2009 IRF
PPS final rule (73 FR 46370), in which
we published the final FY 2009 IRF
federal prospective payment rates.
In the FY 2010 IRF PPS final rule (74
FR 39762) and in correcting
amendments to the FY 2010 IRF PPS
final rule (74 FR 50712) that we
published on October 1, 2009, we
updated the federal prospective
payment rates, the CMG relative
weights, the average length of stay
values, the rural, LIP, and teaching
status adjustment factors, and the
outlier threshold; implemented new IRF
coverage requirements for determining
whether an IRF claim is reasonable and
necessary; and revised the regulation
text to require IRFs to submit patient
assessments on Medicare Advantage
(MA) (Medicare Part C) patients for use
in the 60 percent rule calculations. Any
reference to the FY 2010 IRF PPS final
PO 00000
Frm 00004
Fmt 4701
Sfmt 4700
rule in this final rule also includes the
provisions effective in the correcting
amendments. For more information on
the policy changes implemented for FY
2010, please refer to the FY 2010 IRF
PPS final rule (74 FR 39762 and 74 FR
50712), in which we published the final
FY 2010 IRF federal prospective
payment rates.
After publication of the FY 2010 IRF
PPS final rule (74 FR 39762), section
3401(d) of the Patient Protection and
Affordable Care Act (Pub. L. 111–148,
enacted on March 23, 2010), as
amended by section 10319 of the same
Act and by section 1105 of the Health
Care and Education Reconciliation Act
of 2010 (Pub. L. 111–152, enacted on
March 30, 2010) (collectively, hereafter
referred to as ‘‘The Affordable Care
Act’’), amended section 1886(j)(3)(C) of
the Act and added section 1886(j)(3)(D)
of the Act. Section 1886(j)(3)(C) of the
Act requires the Secretary to estimate a
multi-factor productivity adjustment to
the market basket increase factor, and to
apply other adjustments as defined by
the Act. The productivity adjustment
applies to FYs from 2012 forward. The
other adjustments apply to FYs 2010 to
2019.
Sections 1886(j)(3)(C)(ii)(II) and
1886(j)(3)(D)(i) of the Act defined the
adjustments that were to be applied to
the market basket increase factors in
FYs 2010 and 2011. Under these
provisions, the Secretary was required
to reduce the market basket increase
factor in FY 2010 by a 0.25 percentage
point adjustment. Notwithstanding this
provision, in accordance with section
3401(p) of the Affordable Care Act, the
adjusted FY 2010 rate was only to be
applied to discharges occurring on or
after April 1, 2010. Based on the selfimplementing legislative changes to
section 1886(j)(3) of the Act, we
adjusted the FY 2010 federal
prospective payment rates as required,
and applied these rates to IRF
discharges occurring on or after April 1,
2010 and on or before September 30,
2010. Thus, the final FY 2010 IRF
federal prospective payment rates that
were published in the FY 2010 IRF PPS
final rule (74 FR 39762) were used for
discharges occurring on or after October
1, 2009 and on or before March 31,
2010; and the adjusted FY 2010 IRF
federal prospective payment rates
applied to discharges occurring on or
after April 1, 2010 and on or before
September 30, 2010. The adjusted FY
2010 federal prospective payment rates
are available on the CMS Web site at:
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
InpatientRehabFacPPS/Data-Files.html.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
In addition, sections 1886(j)(3)(C) and
(D) of the Act also affected the FY 2010
IRF outlier threshold amount because
they required an adjustment to the FY
2010 RPL market basket increase factor,
which changed the standard payment
conversion factor for FY 2010.
Specifically, the original FY 2010 IRF
outlier threshold amount was
determined based on the original
estimated FY 2010 RPL market basket
increase factor of 2.5 percent and the
standard payment conversion factor of
$13,661. However, as adjusted, the IRF
prospective payments are based on the
adjusted RPL market basket increase
factor of 2.25 percent and the revised
standard payment conversion factor of
$13,627. To maintain estimated outlier
payments for FY 2010 equal to the
established standard of 3 percent of total
estimated IRF PPS payments for FY
2010, we revised the IRF outlier
threshold amount for FY 2010 for
discharges occurring on or after April 1,
2010 and on or before September 30,
2010. The revised IRF outlier threshold
amount for FY 2010 was $10,721.
Sections 1886(j)(3)(c)(ii)(II) and
1886(j)(3)(D)(i) of the Act also required
the Secretary to reduce the market
basket increase factor in FY 2011 by a
0.25 percentage point adjustment. The
FY 2011 IRF PPS notice (75 FR 42836)
and the correcting amendments to the
FY 2011 IRF PPS notice (75 FR 70013,
November 16, 2010) described the
required adjustments to the FY 2011
and FY 2010 IRF PPS federal
prospective payment rates and outlier
threshold amount for IRF discharges
occurring on or after April 1, 2010 and
on or before September 30, 2011. It also
updated the FY 2011 federal prospective
payment rates, the CMG relative
weights, and the average length of stay
values. Any reference to the FY 2011
IRF PPS notice in this final rule also
includes the provisions effective in the
correcting amendments. For more
information on the FY 2010 and FY
2011 adjustments or the updates for FY
2011, please refer to the FY 2011 IRF
PPS notice (75 FR 42836 and 75 FR
70013).
In the FY 2012 IRF PPS final rule (76
FR 47836), we updated the IRF federal
prospective payment rates, rebased and
revised the RPL market basket, and
established a new quality reporting
program for IRFs in accordance with
section 1886(j)(7) of the Act. We also
revised regulation text for the purpose
of updating and providing greater
clarity. For more information on the
policy changes implemented for FY
2012, please refer to the FY 2012 IRF
PPS final rule (76 FR 47836), in which
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
we published the final FY 2012 IRF
federal prospective payment rates.
The July 30, 2012 FY 2013 IRF PPS
notice (77 FR 44618) described the
required adjustments to the FY 2013
federal prospective payment rates and
outlier threshold amount for IRF
discharges occurring on or after October
1, 2012 and on or before September 30,
2013. It also updated the FY 2013
federal prospective payment rates, the
CMG relative weights, and the average
length of stay values. For more
information on the updates for FY 2013,
please refer to the July 30, 2012 FY 2013
IRF PPS notice (77 FR 44618).
B. Provisions of the Affordable Care Act
Affecting the IRF PPS in FY 2012 and
Beyond
The Affordable Care Act included
several provisions that affect the IRF
PPS in FYs 2012 and beyond. In
addition to what was discussed above,
section 3401(d) of the Affordable Care
Act also added section
1886(j)(3)(C)(ii)(I) (providing for a
‘‘productivity adjustment’’ for fiscal
year 2012 and each subsequent fiscal
year). The productivity adjustment for
FY 2014 is discussed in section VI.A. of
this final rule. Section 3401(d) of the
Affordable Care Act requires an
additional 0.3 percentage point
adjustment to the IRF increase factor for
FY 2014, as discussed in section VI.A.
of this final rule. Section
1886(j)(3)(C)(ii)(II) of the Act notes that
the application of these adjustments to
the market basket update may result in
an update that is less than 0.0 for a fiscal
year and in payment rates for a fiscal
year being less than such payment rates
for the preceding fiscal year.
Section 3004(b) of the Affordable Care
Act also addressed the IRF PPS
program. It reassigned the previously
designated section 1886(j)(7) of the Act
to section 1886(j)(8) and inserted a new
section 1886(j)(7), which contains new
requirements for the Secretary to
establish a quality reporting program for
IRFs. Under that program, data must be
submitted in a form and manner, and at
a time specified by the Secretary.
Beginning in FY 2014, section
1886(j)(7)(A)(i) of the Act will require
application of a 2 percentage point
reduction of the applicable market
basket increase factor for IRFs that fail
to comply with the quality data
submission requirements. Application
of the 2 percentage point reduction may
result in an update that is less than 0.0
for a fiscal year and in payment rates for
a fiscal year being less than such
payment rates for the preceding fiscal
year. Reporting-based reductions to the
market basket increase factor will not be
PO 00000
Frm 00005
Fmt 4701
Sfmt 4700
47863
cumulative; they will only apply for the
FY involved.
Under section 1886(j)(7)(D)(i) and (ii)
of the Act, the Secretary is generally
required to select quality measures for
the IRF quality reporting program from
those that have been endorsed by the
consensus-based entity which holds a
performance measurement contract
under section 1890(a) of the Act. This
contract is currently held by the
National Quality Forum (NQF). So long
as due consideration is given to
measures that have been endorsed or
adopted by a consensus-based
organization, section 1886(j)(7)(D)(ii) of
the Act authorizes the Secretary to
select non-endorsed measures for
specified areas or medical topics when
there are no feasible or practical
endorsed measure(s). Under section
1886(j)(7)(D)(iii) of the Act, the
Secretary is required to publish the
measures that will be used in FY 2014
no later than October 1, 2012.
Section 1886(j)(7)(E) of the Act
requires the Secretary to establish
procedures for making the IRF PPS
quality reporting data available to the
public. In so doing, the Secretary must
ensure that IRFs have the opportunity to
review any such data prior to its release
to the public. Future rulemaking will
address these public reporting
obligations.
C. Operational Overview of the Current
IRF PPS
As described in the FY 2002 IRF PPS
final rule, upon the admission and
discharge of a Medicare Part A Fee-forService patient, the IRF is required to
complete the appropriate sections of a
patient assessment instrument (PAI),
designated as the Inpatient
Rehabilitation Facility-Patient
Assessment Instrument (IRF–PAI). In
addition, beginning with IRF discharges
occurring on or after October 1, 2009,
the IRF is also required to complete the
appropriate sections of the IRF–PAI
upon the admission and discharge of
each Medicare Part C (Medicare
Advantage) patient, as described in the
FY 2010 IRF PPS final rule. All required
data must be electronically encoded into
the IRF–PAI software product.
Generally, the software product
includes patient classification
programming called the GROUPER
software. The GROUPER software uses
specific IRF–PAI data elements to
classify (or group) patients into distinct
CMGs and account for the existence of
any relevant comorbidities.
The GROUPER software produces a 5digit CMG number. The first digit is an
alpha-character that indicates the
comorbidity tier. The last 4 digits
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47864
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
represent the distinct CMG number.
Free downloads of the Inpatient
Rehabilitation Validation and Entry
(IRVEN) software product, including the
GROUPER software, are available on the
CMS Web site at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/
Software.html.
Once a Medicare Fee-for-Service Part
A patient is discharged, the IRF submits
a Medicare claim as a Health Insurance
Portability and Accountability Act of
1996 (Pub. L. 104–191, enacted on
August 21, 1996) (HIPAA) compliant
electronic claim or, if the
Administrative Simplification
Compliance Act of 2002 (Pub. L. 107–
105, enacted on December 27, 2002)
(ASCA) permits, a paper claim (a UB–
04 or a CMS–1450 as appropriate) using
the five-digit CMG number and sends it
to the appropriate Medicare
Administrative Contractor (MAC). In
addition, once a Medicare Advantage
patient is discharged, in accordance
with the Medicare Claims Processing
Manual chapter 3 section 20.3 (Pub.
100–04), hospitals (including IRFs) must
submit an informational-only bill (TOB
111) which includes Condition Code 04
to their Medicare contractor. This will
ensure that the Medicare Advantage
days are included in the hospital’s
Supplemental Security Income (SSI)
ratio (used in calculating the IRF lowincome percentage adjustment) for
Fiscal Year 2007 and beyond. Claims
submitted to Medicare must comply
with both ASCA and HIPAA.
Section 3 of the ASCA amends section
1862(a) of the Act by adding paragraph
(22) which requires the Medicare
program, subject to section 1862(h) of
the Act, to deny payment under Part A
or Part B for any expenses for items or
services ‘‘for which a claim is submitted
other than in an electronic form
specified by the Secretary.’’ Section
1862(h) of the Act, in turn, provides that
the Secretary shall waive such denial in
situations in which there is no method
available for the submission of claims in
an electronic form or the entity
submitting the claim is a small provider.
In addition, the Secretary also has the
authority to waive such denial ‘‘in such
unusual cases as the Secretary finds
appropriate.’’ For more information, see
the ‘‘Medicare Program; Electronic
Submission of Medicare Claims’’ final
rule (70 FR 71008, November 25, 2005).
Our instructions for the limited number
of Medicare claims submitted on paper
are available at https://www.cms.gov/
manuals/downloads/clm104c25.pdf.
Section 3 of the ASCA operates in the
context of the administrative
simplification provisions of HIPAA,
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
which include, among others, the
requirements for transaction standards
and code sets codified in 45 CFR, parts
160 and 162, subparts A and I through
R (generally known as the Transactions
Rule). The Transactions Rule requires
covered entities, including covered
healthcare providers, to conduct
covered electronic transactions
according to the applicable transaction
standards. (See the CMS program claim
memoranda at https://www.cms.gov/
ElectronicBillingEDITrans/ and listed in
the addenda to the Medicare
Intermediary Manual, Part 3, section
3600).
The MAC processes the claim through
its software system. This software
system includes pricing programming
called the ‘‘PRICER’’ software. The
PRICER software uses the CMG number,
along with other specific claim data
elements and provider-specific data, to
adjust the IRF’s prospective payment for
interrupted stays, transfers, short stays,
and deaths, and then applies the
applicable adjustments to account for
the IRF’s wage index, percentage of lowincome patients, rural location, and
outlier payments. For discharges
occurring on or after October 1, 2005,
the IRF PPS payment also reflects the
teaching status adjustment that became
effective as of FY 2006, as discussed in
the FY 2006 IRF PPS final rule (70 FR
47880).
II. Summary of Provisions of the
Proposed Rule
In the FY 2014 IRF PPS proposed rule
(78 FR 26880), we proposed to update
the IRF Federal prospective payment
rates, to revise the list of eligible
International Classification of Diseases,
Ninth Revision, Clinical Modification
(ICD–9–CM) diagnosis codes that are
used to determine presumptive
compliance under the ‘‘60 percent rule,’’
to update the IRF facility-level
adjustment factors, to revise the
Inpatient Rehabilitation Facility-Patient
Assessment Instrument (IRF–PAI), to
revise requirements for acute care
hospitals that have IRF units, clarify the
IRF regulation text regarding limitation
of review, and to revise and update
quality measures and reporting
requirements under the quality
reporting program for IRFs. We also
proposed to revise existing regulations
text for the purpose of updating and
providing greater clarity. These
proposals were as follows:
PO 00000
Frm 00006
Fmt 4701
Sfmt 4700
A. Proposed Updates to the IRF Federal
Prospective Payment Rates for Federal
Fiscal Year (FY) 2014
The proposed updates to the IRF
federal prospective payment rates for FY
2014 were as follows:
• Update the FY 2014 IRF PPS
relative weights and average length of
stay values using the most current and
complete Medicare claims and cost
report data in a budget-neutral manner,
as discussed in section III. of the FY
2014 IRF PPS proposed rule (78 FR
26880, 26885 through 26888).
• Update the FY 2014 IRF PPS
facility-level adjustment factors, using
the most current and complete Medicare
claims and cost report data with an
enhanced estimation methodology, in a
budget-neutral manner, as discussed in
section IV of the FY 2014 IRF PPS
proposed rule (78 FR 26880, 26888
through 26890).
• Update the FY 2014 IRF PPS
payment rates by the proposed market
basket increase factor, based upon the
most current data available, with a 0.3
percentage point reduction as required
by sections 1886(j)(3)(C)(ii)(II) and
1886(j)(3)(D)(iii) of the Act and a
proposed productivity adjustment
required by section 1886(j)(3)(C)(ii)(I) of
the Act, as described in section V of the
FY 2014 IRF PPS proposed rule (78 FR
26880, 26890 through 26891).
• Discuss the Secretary’s Proposed
Recommendation for updating IRF PPS
payments for FY 2014, in accordance
with the statutory requirements, as
described in section V of the FY 2014
IRF PPS proposed rule (78 FR 26880 at
26891).
• Update the FY 2014 IRF PPS
payment rates by the FY 2014 wage
index and the labor-related share in a
budget-neutral manner, as discussed in
section V of the FY 2014 IRF PPS
proposed rule (78 FR 26880, 26891
through 26892).
• Describe the calculation of the IRF
Standard Payment Conversion Factor for
FY 2014, as discussed in section V of
the FY 2014 IRF PPS proposed rule (78
FR 26880 at 26892).
• Update the outlier threshold
amount for FY 2014, as discussed in
section VI of the FY 2014 IRF PPS
proposed rule (78 FR 26880 at 26895).
• Update the cost-to-charge ratio
(CCR) ceiling and urban/rural average
CCRs for FY 2014, as discussed in
section VI of the FY 2014 IRF PPS
proposed rule (78 FR 26880 at 26895).
• Describe proposed revisions to the
list of eligible ICD–9–CM diagnosis
codes that are used to determine
presumptive compliance under the 60
percent rule in section VII of the FY
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
2014 IRF PPS proposed rule (78 FR
26880, 26895 through 26906).
• Describe proposed non-qualityrelated revisions to IRF–PAI sections in
section VIII of the FY 2014 IRF PPS
proposed rule (78 FR 26880, 26906
through 26907).
• Describe proposed revisions and
updates to quality measures and
reporting requirements under the
quality reporting program for IRFs in
accordance with section 1886(j)(7) of the
Act, as discussed in section XIII of the
FY 2014 IRF PPS proposed rule (78 FR
26880, 26909 through 26922).
tkelley on DSK3SPTVN1PROD with RULES2
B. Proposed Revisions to Existing
Regulation Text
In the FY 2014 IRF PPS proposed rule
(78 FR 26880), we also proposed the
following revisions to the existing
regulations:
• Revisions to § 412.25(a)(1)(iii) to
specify a minimum required number of
beds that are not excluded from the
inpatient prospective payment system
(IPPS) for a hospital that has an IRF
unit, as described in section X of the FY
2014 IRF PPS proposed rule (78 FR
26880 at 26908).
• Technical corrections to § 412.130,
to reflect prior changes to the
regulations at § 412.29 and § 412.30 that
we made in the FY 2012 IRF PPS final
rule (76 FR 47836), as described in
section IX of the FY 2014 IRF PPS
proposed rule (78 FR 26880, 26907
through 26908).
• Clarifications to § 412.630, to reflect
the scope of section 1886(j)(8) of the
Act, as described in section XI. of the
FY 2014 IRF PPS proposed rule (78 FR
26880 at 26908).
• Revision to § 412.29(d), to clarify
that Medicare requires the rehabilitation
physician’s review and concurrence on
the preadmission screening for
Medicare Part A Fee-for-Service patients
only, as described in section XII of the
FY 2014 IRF PPS proposed rule (78 FR
26880, 26908 through 26909).
III. Analysis and Responses to Public
Comments
We received 47 timely responses from
the public, many of which contained
multiple comments on the FY 2014 IRF
PPS proposed rule (78 FR 26880). We
received comments from various trade
associations, inpatient rehabilitation
facilities, individual physicians,
therapists, clinicians, health care
industry organizations, law firms and
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
health care consulting firms. The
following sections, arranged by subject
area, include a summary of the public
comments that we received, and our
responses.
IV. Update to the Case-Mix Group
(CMG) Relative Weights and Average
Length of Stay Values for FY 2014
As specified in § 412.620(b)(1), we
calculate a relative weight for each CMG
that is proportional to the resources
needed by an average inpatient
rehabilitation case in that CMG. For
example, cases in a CMG with a relative
weight of 2, on average, will cost twice
as much as cases in a CMG with a
relative weight of 1. Relative weights
account for the variance in cost per
discharge due to the variance in
resource utilization among the payment
groups, and their use helps to ensure
that IRF PPS payments support
beneficiary access to care, as well as
provider efficiency.
In the FY 2014 IRF PPS proposed rule
(78 FR 26880, 26885 through 26888), we
proposed to update the CMG relative
weights and average length of stay
values for FY 2014. As required by
statute, we always use the most recent
available data to update the CMG
relative weights and average lengths of
stay. For FY 2014, we proposed to use
the FY 2012 IRF claims and FY 2011
IRF cost report data. These data are the
most current and complete data
available at this time. Currently, only a
small portion of the FY 2012 IRF cost
report data are available for analysis, but
the majority of the FY 2012 IRF claims
data are available for analysis.
In the FY 2014 IRF PPS proposed rule
(78 FR 26880, 26885 through 26888), we
proposed to apply these data using the
same methodologies that we have used
to update the CMG relative weights and
average length of stay values in the FY
2011 notice (75 FR 42836), the FY 2012
final rule (76 FR 47836), and the FY
2013 notice (77 FR 44618). In
calculating the CMG relative weights,
we use a hospital-specific relative value
method to estimate operating (routine
and ancillary services) and capital costs
of IRFs. The process used to calculate
the CMG relative weights is as follows:
Step 1. We estimate the effects that
comorbidities have on costs.
Step 2. We adjust the cost of each
Medicare discharge (case) to reflect the
effects found in the first step.
PO 00000
Frm 00007
Fmt 4701
Sfmt 4700
47865
Step 3. We use the adjusted costs from
the second step to calculate CMG
relative weights, using the hospitalspecific relative value method.
Step 4. We normalize the FY 2014
CMG relative weights to the same
average CMG relative weight from the
CMG relative weights implemented in
the July 30, 2012 FY 2013 IRF PPS
notice (77 FR 44618).
Consistent with the methodology that
we have used to update the IRF
classification system in each instance in
the past, we proposed to update the
CMG relative weights for FY 2014 in
such a way that total estimated
aggregate payments to IRFs for FY 2014
are the same with or without the
changes (that is, in a budget-neutral
manner) by applying a budget neutrality
factor to the standard payment amount.
To calculate the appropriate budget
neutrality factor for use in updating the
FY 2014 CMG relative weights, we use
the following steps:
Step 1. Calculate the estimated total
amount of IRF PPS payments for FY
2014 (with no changes to the CMG
relative weights).
Step 2. Calculate the estimated total
amount of IRF PPS payments for FY
2014 by applying the changes to the
CMG relative weights (as discussed
above).
Step 3. Divide the amount calculated
in step 1 by the amount calculated in
step 2 to determine the budget
neutrality factor (1.0000) that would
maintain the same total estimated
aggregate payments in FY 2014 with and
without the changes to the CMG relative
weights.
Step 4. Apply the budget neutrality
factor (1.0000) to the FY 2013 IRF PPS
standard payment amount after the
application of the budget-neutral wage
adjustment factor.
In section VI.E. of this final rule, we
discuss the use of the existing
methodology to calculate the standard
payment conversion factor for FY 2014.
Table 1, ‘‘Relative Weights and
Average Length of Stay Values for CaseMix Groups,’’ presents the CMGs, the
comorbidity tiers, the corresponding
relative weights, and the average length
of stay values for each CMG and tier for
FY 2014. The average length of stay for
each CMG is used to determine when an
IRF discharge meets the definition of a
short-stay transfer, which results in a
per diem case level adjustment.
E:\FR\FM\06AUR2.SGM
06AUR2
47866
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
TABLE 1—RELATIVE WEIGHTS AND AVERAGE LENGTH OF STAY VALUES FOR CASE-MIX GROUPS
0101 .......
0102 .......
0103 .......
0104
0105
0106
0107
0108
0109
.......
.......
.......
.......
.......
.......
0110 .......
0201 .......
0202 .......
0203 .......
0204 .......
0205 .......
0206 .......
0207 .......
0301 .......
0302 .......
0303 .......
0304 .......
0401 .......
0402 .......
0403 .......
0404 .......
0405 .......
0501 .......
0502 .......
0503 .......
0504 .......
0505 .......
0506
0601
0602
0603
0604
0701
0702
.......
.......
.......
.......
.......
.......
.......
tkelley on DSK3SPTVN1PROD with RULES2
0703 .......
0704 .......
0801 .......
0802 .......
0803 .......
0804 .......
Relative weight
CMG Description (M = motor,
C = cognitive, A = age)
CMG
Tier 1
Stroke M > 51.05 .........................................
Stroke M > 44.45 and M < 51.05 and C >
18.5.
Stroke M > 44.45 and M < 51.05 and C <
18.5.
Stroke M > 38.85 and M < 44.45 ................
Stroke M > 34.25 and M < 38.85 ................
Stroke M > 30.05 and M < 34.25 ................
Stroke M > 26.15 and M < 30.05 ................
Stroke M < 26.15 and A > 84.5 ...................
Stroke M > 22.35 and M < 26.15 and A <
84.5.
Stroke M < 22.35 and A < 84.5 ...................
Traumatic brain injury M > 53.35 and C >
23.5.
Traumatic brain injury M > 44.25 and M <
53.35 and C > 23.5.
Traumatic brain injury M > 44.25 and C <
23.5.
Traumatic brain injury M > 40.65 and M <
44.25.
Traumatic brain injury M > 28.75 and M <
40.65.
Traumatic brain injury M > 22.05 and M <
28.75.
Traumatic brain injury M < 22.05 ................
Non-traumatic brain injury M > 41.05 ..........
Non-traumatic brain injury M > 35.05 and M
< 41.05.
Non-traumatic brain injury M > 26.15 and M
< 35.05.
Non-traumatic brain injury M < 26.15 ..........
Traumatic spinal cord injury M > 48.45 .......
Traumatic spinal cord injury M > 30.35 and
M < 48.45.
Traumatic spinal cord injury M > 16.05 and
M < 30.35.
Traumatic spinal cord injury M < 16.05 and
A > 63.5.
Traumatic spinal cord injury M < 16.05 and
A < 63.5.
Non-traumatic spinal cord injury M > 51.35
Non-traumatic spinal cord injury M > 40.15
and M < 51.35.
Non-traumatic spinal cord injury M > 31.25
and M < 40.15.
Non-traumatic spinal cord injury M > 29.25
and M < 31.25.
Non-traumatic spinal cord injury M > 23.75
and M < 29.25.
Non-traumatic spinal cord injury M < 23.75
Neurological M > 47.75 ...............................
Neurological M > 37.35 and M < 47.75 .......
Neurological M > 25.85 and M < 37.35 .......
Neurological M < 25.85 ...............................
Fracture of lower extremity M > 42.15 ........
Fracture of lower extremity M > 34.15 and
M < 42.15.
Fracture of lower extremity M > 28.15 and
M < 34.15.
Fracture of lower extremity M < 28.15 ........
Replacement of lower extremity joint M >
49.55.
Replacement of lower extremity joint M >
37.05 and M < 49.55.
Replacement of lower extremity joint M >
28.65 and M < 37.05 and A > 83.5.
Replacement of lower extremity joint M >
28.65 and M < 37.05 and A < 83.5.
VerDate Mar<15>2010
21:13 Aug 05, 2013
Jkt 229001
PO 00000
Average length of stay
Tier 2
Tier 3
None
0.7983
0.9911
0.7151
0.8878
0.6539
0.8118
0.6239
0.7745
9
11
9
12
9
10
8
10
1.1608
1.0398
0.9508
0.9071
13
13
12
11
1.2212
1.4275
1.6285
1.8385
2.3157
2.0990
1.0939
1.2787
1.4588
1.6468
2.0743
1.8802
1.0002
1.1692
1.3339
1.5059
1.8967
1.7192
0.9543
1.1155
1.2726
1.4367
1.8096
1.6403
13
15
16
19
22
21
12
15
17
20
24
21
12
14
16
17
22
19
12
14
15
17
21
20
2.7382
0.8252
2.4527
0.6953
2.2427
0.6182
2.1398
0.5757
29
10
28
10
25
8
25
8
1.0549
0.8889
0.7904
0.7360
12
10
10
10
1.2520
1.0550
0.9380
0.8735
15
13
12
11
1.3077
1.1020
0.9798
0.9124
12
13
12
12
1.5791
1.3307
1.1831
1.1017
17
16
14
14
1.9472
1.6409
1.4589
1.3585
18
19
18
16
2.5767
1.0984
1.3755
2.1713
0.9453
1.1838
1.9305
0.8469
1.0606
1.7977
0.7832
0.9808
33
10
13
26
11
14
21
11
12
20
10
12
1.6219
1.3958
1.2506
1.1565
17
16
14
14
2.1792
1.1342
1.4129
1.8755
0.9427
1.1744
1.6803
0.8778
1.0936
1.5539
0.7849
0.9778
24
12
18
21
12
14
19
11
15
18
10
12
2.3155
1.9246
1.7921
1.6024
26
24
20
20
4.2535
3.5355
3.2921
2.9436
47
41
36
35
3.4992
2.9086
2.7083
2.4216
37
32
33
27
0.8384
1.1090
0.6587
0.8712
0.6208
0.8211
0.5653
0.7477
9
12
9
11
8
10
8
10
1.4334
1.1261
1.0613
0.9664
15
13
13
12
1.6565
1.3014
1.2265
1.1168
14
16
14
14
1.9708
1.5483
1.4592
1.3287
21
18
17
16
2.7518
0.9645
1.2974
1.6228
2.1683
0.9369
1.2132
2.1619
0.7830
1.0533
1.3174
1.7603
0.7995
1.0353
2.0375
0.7227
0.9721
1.2159
1.6246
0.7648
0.9904
1.8553
0.6551
0.8811
1.1021
1.4726
0.6945
0.8993
30
10
12
15
22
10
12
25
10
12
15
19
10
12
23
9
11
14
18
10
12
22
9
11
13
17
9
11
1.4741
1.2579
1.2033
1.0927
15
15
14
13
1.8716
0.7037
1.5971
0.6193
1.5278
0.5667
1.3874
0.5186
18
7
18
8
18
7
17
7
0.9255
0.8145
0.7454
0.6821
10
10
9
9
1.2589
1.1078
1.0138
0.9277
12
14
13
12
1.1139
0.9803
0.8971
0.8209
11
12
11
10
Frm 00008
Fmt 4701
Sfmt 4700
E:\FR\FM\06AUR2.SGM
Tier 1
06AUR2
Tier 2
Tier 3
None
47867
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
TABLE 1—RELATIVE WEIGHTS AND AVERAGE LENGTH OF STAY VALUES FOR CASE-MIX GROUPS—Continued
CMG Description (M = motor, C = cognitive, A = age)
CMG
0805 .......
0806 .......
0901
0902
0903
0904
1001
1002
.......
.......
.......
.......
.......
.......
1003
1101
1102
1201
1202
1203
1301
1302
.......
.......
.......
.......
.......
.......
.......
.......
1303
1401
1402
1403
1404
1501
1502
1503
1504
1601
1602
1603
1701
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
1702 .......
1703 .......
1704 .......
1801 .......
1802 .......
1803 .......
1901
1902
1903
2001
2002
2003
2004
2101
5001
.......
.......
.......
.......
.......
.......
.......
.......
.......
5101 .......
5102 .......
tkelley on DSK3SPTVN1PROD with RULES2
5103 .......
5104 .......
Replacement of lower extremity joint M >
22.05 and M < 28.65.
Replacement of lower extremity joint M <
22.05.
Other orthopedic M > 44.75 ........................
Other orthopedic M > 34.35 and M < 44.75
Other orthopedic M > 24.15 and M < 34.35
Other orthopedic M < 24.15 ........................
Amputation, lower extremity M > 47.65 .......
Amputation, lower extremity M > 36.25 and
M < 47.65.
Amputation, lower extremity M < 36.25 .......
Amputation, non-lower extremity M > 36.35
Amputation, non-lower extremity M < 36.35
Osteoarthritis M > 37.65 ..............................
Osteoarthritis M > 30.75 and M < 37.65 .....
Osteoarthritis M < 30.75 ..............................
Rheumatoid, other arthritis M > 36.35 .........
Rheumatoid, other arthritis M > 26.15 and
M < 36.35.
Rheumatoid, other arthritis M < 26.15 .........
Cardiac M > 48.85 .......................................
Cardiac M > 38.55 and M < 48.85 ..............
Cardiac M > 31.15 and M < 38.55 ..............
Cardiac M < 31.15 .......................................
Pulmonary M > 49.25 ..................................
Pulmonary M > 39.05 and M < 49.25 .........
Pulmonary M > 29.15 and M < 39.05 .........
Pulmonary M < 29.15 ..................................
Pain syndrome M > 37.15 ...........................
Pain syndrome M > 26.75 and M < 37.15 ..
Pain syndrome M < 26.75 ...........................
Major multiple trauma without brain or spinal cord injury M > 39.25.
Major multiple trauma without brain or spinal cord injury M > 31.05 and M < 39.25.
Major multiple trauma without brain or spinal cord injury M > 25.55 and M < 31.05.
Major multiple trauma without brain or spinal cord injury M < 25.55.
Major multiple trauma with brain or spinal
cord injury M > 40.85.
Major multiple trauma with brain or spinal
cord injury M > 23.05 and M < 40.85.
Major multiple trauma with brain or spinal
cord injury M < 23.05.
Guillain Barre M > 35.95 .............................
Guillain Barre M > 18.05 and M < 35.95 .....
Guillain Barre M < 18.05 .............................
Miscellaneous M > 49.15 .............................
Miscellaneous M > 38.75 and M < 49.15 ....
Miscellaneous M > 27.85 and M < 38.75 ....
Miscellaneous M < 27.85 .............................
Burns M > 0 .................................................
Short-stay cases, length of stay is 3 days
or fewer.
Expired, orthopedic, length of stay is 13
days or fewer.
Expired, orthopedic, length of stay is 14
days or more.
Expired, not orthopedic, length of stay is 15
days or fewer.
Expired, not orthopedic, length of stay is 16
days or more.
Generally, updates to the CMG
relative weights result in some increases
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
Relative weight
Average length of stay
Tier 1
Tier 2
Tier 3
None
1.3754
1.2104
1.1077
1.0136
15
15
13
12
1.6683
1.4682
1.3435
1.2294
17
17
15
15
0.9010
1.2081
1.5080
1.9669
1.0276
1.3077
0.7452
0.9992
1.2472
1.6268
0.9345
1.1892
0.6891
0.9241
1.1534
1.5045
0.8023
1.0210
0.6241
0.8369
1.0446
1.3626
0.7417
0.9439
10
13
15
20
12
13
9
12
15
19
11
13
9
11
14
17
10
12
8
11
13
16
10
12
1.9362
1.2199
1.7115
0.9454
1.1749
1.4677
1.1678
1.5025
1.7608
1.1157
1.5652
0.9411
1.1695
1.4609
0.9974
1.2832
1.5117
1.0302
1.4454
0.8445
1.0495
1.3110
0.9062
1.1659
1.3975
1.0056
1.4107
0.7724
0.9599
1.1991
0.8219
1.0575
19
13
16
9
14
13
12
16
20
13
17
11
14
18
10
15
17
12
16
10
13
15
11
14
16
12
17
10
12
14
10
13
1.9254
0.8869
1.1928
1.4581
1.8587
1.0128
1.2651
1.5357
1.9057
1.0707
1.3889
1.7566
1.1053
1.6444
0.7263
0.9768
1.1941
1.5222
0.8635
1.0787
1.3094
1.6248
0.8883
1.1523
1.4573
0.9551
1.4941
0.6555
0.8816
1.0777
1.3738
0.7803
0.9747
1.1832
1.4683
0.8327
1.0802
1.3662
0.8619
1.3551
0.5937
0.7985
0.9761
1.2443
0.7474
0.9336
1.1333
1.4063
0.7639
0.9909
1.2533
0.7769
18
9
12
14
19
10
12
15
21
9
12
18
11
18
9
11
14
17
9
12
14
17
10
14
17
12
17
8
11
12
15
9
11
13
16
10
12
15
11
16
8
10
12
14
9
11
13
15
9
12
15
10
1.3905
1.2016
1.0843
0.9774
13
15
13
12
1.6553
1.4304
1.2908
1.1635
17
16
15
14
2.1005
1.8152
1.6380
1.4764
24
20
18
18
1.1378
1.0183
0.9216
0.7648
13
12
12
10
1.7508
1.5669
1.4182
1.1769
18
19
17
14
2.7973
2.5035
2.2659
1.8804
33
28
24
22
1.0836
2.1258
3.5333
0.8877
1.1867
1.4947
1.9610
2.1953
..............
0.9288
1.8221
3.0287
0.7267
0.9714
1.2235
1.6051
1.5624
..............
0.8847
1.7355
2.8846
0.6691
0.8945
1.1266
1.4780
1.5111
..............
0.8716
1.7097
2.8418
0.6107
0.8164
1.0283
1.3490
1.4146
0.1538
14
23
56
9
12
15
20
24
..............
10
21
32
9
11
14
18
21
..............
11
19
31
8
11
13
17
17
..............
11
20
30
8
10
12
15
17
3
..............
..............
..............
0.6617
..............
..............
..............
8
..............
..............
..............
1.4346
..............
..............
..............
17
..............
..............
..............
0.7653
..............
..............
..............
8
..............
..............
..............
1.9685
..............
..............
..............
21
and some decreases to the CMG relative
weight values. Table 2 shows how the
PO 00000
Frm 00009
Fmt 4701
Sfmt 4700
Tier 1
Tier 2
Tier 3
None
application of the revisions for FY 2014
will affect particular CMG relative
E:\FR\FM\06AUR2.SGM
06AUR2
47868
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
weight values, which affect the overall
distribution of payments within CMGs
and tiers. Note that, because we are
implementing the CMG relative weight
revisions in a budget-neutral manner (as
described above), total estimated
aggregate payments to IRFs for FY 2014
will not be affected as a result of the
CMG relative weight revisions.
However, the revisions will affect the
distribution of payments within CMGs
and tiers.
TABLE 2—DISTRIBUTIONAL EFFECTS OF THE CHANGES TO THE CMG RELATIVE WEIGHTS (FY 2013 VALUES COMPARED
WITH FY 2014 VALUES)
Number of cases
affected
Percentage change
tkelley on DSK3SPTVN1PROD with RULES2
Increased by 15% or more ..............................................................................................................................
Increased by between 5% and 15% ...............................................................................................................
Changed by less than 5% ...............................................................................................................................
Decreased by between 5% and 15% ..............................................................................................................
Decreased by 15% or more ............................................................................................................................
As Table 2 shows, almost 99 percent
of all IRF cases are in CMGs and tiers
that will experience less than a 5
percent change (either increase or
decrease) in the CMG relative weight
value as a result of the revisions for FY
2014. The largest increase in the CMG
relative weight values that affects a
particularly large number of IRF
discharges is a 0.8 percent increase in
the CMG relative weight value for CMG
0704—Fracture of Lower Extremity,
with a motor score less than 28.15—in
the ‘‘no comorbidity’’ tier. In the FY
2012 data, 19,981 IRF discharges (5.4
percent of all IRF discharges) were
classified into this CMG and tier.
The largest decrease in a CMG relative
weight value affecting the most cases is
a 2.1 percent decrease in the CMG
relative weight for CMG 0903—Other
Orthopedic with a motor score between
24.15 and 34.35—in the no comorbidity
tier. In the FY 2012 IRF claims data, this
change affects 7,047 cases (1.9 percent
of all IRF cases).
The changes in the average length of
stay values for FY 2014, compared with
the FY 2013 average length of stay
values, are small and do not show any
particular trends in IRF length of stay
patterns.
We received 3 comments on the
proposed updates to the CMG relative
weights and average length of stay
values for FY 2014, which are
summarized below.
Comment: Several commenters
supported the use of the same
methodology that we used in the FY
2011 notice, the FY 2012 final rule, and
the FY 2013 notice to update the CMG
relative weights and average length of
stay values for FY 2014, using the most
recent available data. However, one
commenter expressed concern about
changes to some of the specific CMG
relative weights, indicating that some of
the changes were not necessary and that
others might affect whether or not the
CMGs would be adequately
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
compensating providers for treating
certain types of patients requiring
unusually high-cost treatments.
Response: We believe that updating
the relative weights using the most
recent available data ensures that the
payments per case continue to
accurately reflect the costs of care
provided in IRFs. Although we
acknowledge the commenter’s concerns
with some of the specific CMG relative
weight changes, these changes are based
on IRFs’ reported costs of care for these
types of cases, and we believe that it is
essential to recognize these reported
costs to ensure that the CMG relative
weights reflect as closely as possible the
relative costs of treating different types
of patients in IRFs. Further, we note that
the IRF PPS high-cost outlier policy is
designed to compensate IRFs for
providing care to patients whose costs
greatly exceed the average cost of a case
in a particular CMG and tier.
Comment: A few commenters
requested that we outline the
methodology used to calculate the
average length of stay values. These
same commenters agreed that the
average length of stay values should
only be used to determine when an IRF
discharge meets the definition of a
short-stay transfer, which results in a
per diem case level adjustment, and are
not intended to be used as clinical
guidelines for patients’ lengths of stay in
an IRF.
Response: We will post our
methodology for calculating the average
length of stay values on the IRF PPS
Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/
Research.html in conjunction with the
publication of this final rule.
We continue to support the
commenters’ position that the average
length of stay values in the rule are not
intended as ‘‘targets’’ or as clinical
guidelines for determining a patient’s
length of stay in the IRF. A patient’s
PO 00000
Frm 00010
Fmt 4701
Sfmt 4700
Percentage of
cases affected
0
2,492
363,629
2,118
97
0.0
0.7
98.7
0.6
0.0
length of stay in the IRF should be
determined by the patient’s individual
care needs.
Final Decision: After careful
consideration of the public comments,
we are finalizing our proposal to update
the CMG relative weight and average
length of stay values for FY 2014. These
updates are effective October 1, 2013.
V. Updates to the Facility-Level
Adjustment Factors for FY 2014
A. Background on Facility-Level
Adjustments
Section 1886(j)(3)(A)(v) of the Act
confers broad authority upon the
Secretary to adjust the per unit payment
rate ‘‘by such . . . factors as the
Secretary determines are necessary to
properly reflect variations in necessary
costs of treatment among rehabilitation
facilities.’’ For example, we adjust the
federal prospective payment amount
associated with a CMG to account for
facility-level characteristics such as an
IRF’s LIP, teaching status, and location
in a rural area, if applicable, as
described in § 412.624(e).
In the FY 2010 IRF PPS final rule (74
FR 39762), we updated the adjustment
factors for calculating the rural, LIP, and
teaching status adjustments based on
the most recent three consecutive years’
worth of IRF claims data (at that time,
FY 2006, FY 2007, and FY 2008) and the
most recent available corresponding IRF
cost report data. As discussed in the FY
2010 IRF PPS proposed rule (74 FR
21060 through 21061), we observed
relatively large year-to-year fluctuations
in the underlying data used to compute
the adjustment factors, especially the
teaching status adjustment factor.
Therefore, we implemented a 3-year
moving average approach to updating
the facility-level adjustment factors in
the FY 2010 IRF PPS final rule (74 FR
39762) to provide greater stability and
predictability of Medicare payments for
IRFs.
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
Each year, we review the major
components of the IRF PPS to maintain
and enhance the accuracy of the
payment system. For FY 2010, we
implemented a change to our
methodology that was designed to
decrease the IRF PPS volatility by using
a 3-year moving average to calculate the
facility-level adjustment factors. For FY
2011, we issued a notice to update the
payment rates, which did not include
any policy changes or changes to the
IRF facility-level adjustments. As we
found that the implementation of the 3year moving average did not fully
address year-to-year fluctuations, in the
FY 2012 IRF PPS proposed rule (76 FR
24214 at 24225 through 24226) we
analyzed the effects of having used a
weighting methodology. The
methodology assigned greater weight to
some facilities than to others in the
regression analysis used to estimate the
facility-level adjustment factors. As we
found that this weighting methodology
inappropriately exaggerated the cost
differences among different types of IRF
facilities, we proposed to remove the
weighting factor from our analysis and
update the IRF facility-level adjustment
factors for FY 2012 using an unweighted regression analysis. However,
after carefully considering all of the
comments that we received on the
proposed FY 2012 updates to the
facility-level adjustment factors, we
decided to hold the facility-level
adjustment factors at FY 2011 levels for
FY 2012 to conduct further research on
the underlying data and the best
methodology for calculating the facilitylevel adjustment factors. We based this
decision, in part, on comments we
received about the financial hardships
that the proposed updates would create
for facilities with teaching programs and
a higher disproportionate share of lowincome patients.
B. Updates to the IRF Facility-Level
Adjustment Factors
Since the FY 2012 final rule (76 FR
47836), we have conducted further
research into the best methodology to
use to estimate the IRF facility-level
adjustment factors, to ensure that the
adjustment factors reflect as accurately
as possible the costs of providing IRF
care across the full spectrum of IRF
providers. Our recent research efforts
have shown that significant differences
exist between the cost structures of
freestanding IRFs and the cost structures
of IRF units of acute care hospitals (and
critical access hospitals, otherwise
known as ‘‘CAHs’’). We have found that
these cost structure differences
substantially influence the estimates of
the adjustment factors. Therefore, we
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
believe that it is important to control for
these cost structure differences between
hospital-based and freestanding IRFs in
our regression analysis, so that these
differences do not inappropriately
influence the adjustment factor
estimates. In Medicare’s payment
system for the treatment of end-stage
renal disease (ESRD), we already control
for the cost structure differences
between hospital-based and
freestanding facilities in the regression
analyses that are used to set payment
rates. Also, we received comments from
an IRF industry association on the FY
2012 IRF PPS proposed rule suggesting
that the addition of this particular
control variable to the model could
improve the methodology for estimating
the IRF facility-level adjustment factors.
Thus, in the FY 2014 IRF PPS
proposed rule, we proposed to add an
indicator variable to our 3-year moving
average methodology for updating the
IRF facility-level adjustments that
would have an assigned value of ‘‘1’’ if
the facility is a freestanding IRF hospital
and have an assigned value of ‘‘0’’ if the
facility is an IRF unit of an acute care
hospital (or CAH). Adding this variable
to the regression analysis enables us to
control for the differences in costs that
are primarily due to the differences in
cost structures between freestanding
and hospital-based IRFs, so that those
differences do not become
inappropriately intertwined with our
estimates of the differences in costs
between rural and urban facilities, high
LIP percentage and low LIP percentage
facilities, and teaching and non-teaching
facilities. Further, by including this
variable in the regression analysis, we
greatly improve our ability to predict an
IRF’s average cost per case (that is, the
R-squared of the regression model
increases from about 11 percent to about
41 percent). In this way, it enhances the
precision with which we can estimate
the IRF facility-level adjustments.
Therefore, in the FY 2014 IRF PPS
proposed rule, we proposed to use the
same methodology used in the FY 2010
IRF PPS final rule (74 FR 39762),
including the 3-year moving average
approach, with the addition of this new
control variable, which equals ‘‘1’’ if the
facility is a freestanding IRF hospital
and ‘‘0’’ if it is an IRF unit of an acute
care hospital (or a CAH). We proposed
to update the adjustment factors using
the most recent three years’ worth of IRF
claims data (FY 2010, FY 2011, and FY
2012) and the most recent available
corresponding IRF cost report data. As
we did in the FY 2010 IRF PPS final rule
(74 FR 39762), we also proposed to use
the cost report data that corresponds
with each IRF claim, when available. In
PO 00000
Frm 00011
Fmt 4701
Sfmt 4700
47869
the rare instances in which the
corresponding year’s cost report data are
not available, we proposed to use the
most recent available cost report data, as
we also did in the FY 2010 IRF PPS final
rule (74 FR 39762).
To calculate the updates to the rural,
LIP, and teaching status adjustment
factors for FY 2014, we use the
following steps:
[Steps 1 and 2 are performed
independently for each of three years of
IRF claims data: FY 2010, FY 2011, and
FY 2012.]
Step 1. Calculate the average cost per
case for each IRF in the IRF claims data.
Step 2. Use logarithmic regression
analysis on average cost per case to
compute the coefficients for the rural,
LIP, and teaching status adjustments.
We proposed to incorporate an
additional indicator variable to account
for whether a facility is a freestanding
IRF hospital or a unit of an acute care
hospital (or a CAH).
Step 3. Calculate a simple mean for
each of the coefficients across the three
years of data (using logarithms for the
LIP and teaching status adjustment
coefficients (because they are
continuous variables), but not for the
rural adjustment coefficient (because the
rural variable is either zero (if not rural)
or 1 (if rural)). To compute the LIP and
teaching status adjustment factors, we
convert these factors back out of the
logarithmic form.
Based on this methodology, we
proposed to update the rural adjustment
factor for FY 2014 from 18.4 percent to
14.9 percent. We proposed to update the
LIP adjustment factor for FY 2014 from
0.4613 to 0.3177 and the teaching status
adjustment factor for FY 2014 from
0.6876 to 1.0163.
C. Budget Neutrality Methodology for
the Updates to the IRF Facility-Level
Adjustment Factors
Consistent with the way that we
implemented changes to the IRF facilitylevel adjustment factors (the rural, LIP,
and teaching status adjustments factors)
in the FY 2006 IRF PPS final rule (70
FR 47880 and 70 FR 57166), which was
the only year in which we updated
these adjustment factors, we proposed
to make changes to the rural, LIP, and
teaching status adjustment factors for
FY 2014 in such a way that total
estimated aggregate payments to IRFs
for FY 2014 would be the same with or
without the proposed changes (that is,
in a budget-neutral manner) by applying
budget neutrality factors for each of
these three changes to the standard
payment amount. To calculate the
budget neutrality factors used to update
the rural, LIP, and teaching status
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47870
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
adjustment factors, we use the following
steps:
Step 1. Using the most recent
available data (currently FY 2012),
calculate the estimated total amount of
IRF PPS payments that would be made
in FY 2014 (without applying the
changes to the rural, LIP, or teaching
status adjustment factors).
Step 2. Calculate the estimated total
amount of IRF PPS payments that will
be made in FY 2014 if the update to the
rural adjustment factor were applied.
Step 3. Divide the amount calculated
in step 1 by the amount calculated in
step 2 to determine the budget
neutrality factor (1.0025) that will
maintain the same total estimated
aggregate payments in FY 2014 with and
without the change to the rural
adjustment factor.
Step 4. Calculate the estimated total
amount of IRF PPS payments that will
be made in FY 2014 if the update to the
LIP adjustment factor were applied.
Step 5. Divide the amount calculated
in step 1 by the amount calculated in
step 4 to determine the budget
neutrality factor (1.0171) that will
maintain the same total estimated
aggregate payments in FY 2014 with and
without the change to the LIP
adjustment factor.
Step 6. Calculate the estimated total
amount of IRF PPS payments that will
be made in FY 2014 if the update to the
teaching status adjustment factor were
applied.
Step 7. Divide the amount calculated
in step 1 by the amount calculated in
step 6 to determine the budget
neutrality factor (0.9962) that will
maintain the same total estimated
aggregate payments in FY 2014 with and
without the change to the teaching
status adjustment factor.
Step 8. Apply the budget neutrality
factors for the updates to the rural, LIP,
and teaching status adjustment factors
to the FY 2013 IRF PPS standard
payment amount after the application of
the budget neutrality factors for the
wage adjustment and the CMG relative
weights.
In section VI.E. of this final rule, we
discuss the methodology for calculating
the standard payment conversion factor
for FY 2014.
We received 19 comments on the
proposed updates to the facility-level
adjustment factors, which are
summarized below.
Comment: Several commenters
expressed concerns about the financial
impact that the reductions to the rural
and LIP adjustments would have on
individual IRFs. These commenters also
expressed concerns about the potential
effects of this policy change combined
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
with possible state Medicaid expansions
under the Affordable Care Act. These
commenters suggested that we delay
implementation until FY 2015, phase in
the updates over multiple years, or
implement a stop-loss policy to mitigate
the financial impact of the changes.
Response: Although we are mindful of
the significant financial impacts on a
small number of individual IRFs of
finalizing these proposals, we believe
that updating the facility level
adjustments as proposed is necessary at
this time to ensure that the adjustment
factors reflect as accurately as possible
the costs of providing IRF care across
the full spectrum of IRF providers. In
addition, we estimate that the maximum
financial impact on any one facility
from these proposed policy changes is
similar to the financial impact that can
result from annual fluctuations in the
geographic wage index values, and we
do not typically implement a delay or
phase-in period to account for annual
wage index fluctuations.
Although we understand that
providers are subject to multiple
financial pressures in today’s economic
climate, the policies established by this
final rule are focused on providing
accurate payment for Medicare Part A
services provided in an IRF setting.
However, we note that, to the extent that
Medicaid coverage is expanded under
the Affordable Care Act provisions, we
believe that this could increase IRFs’
LIP percentages, potentially leading to
higher LIP adjustment payments under
the IRF PPS. We do not believe that
such potential increases in spending for
the LIP adjustment undercut the need to
ensure that LIP adjustment payments
are as fair and accurate as possible for
FY 2014.
Further, whereas the proposed
updates to the facility-level adjustment
factors would decrease payments to
some IRFs, they would increase
payments to other IRFs, by as much as
16.8 percent. By updating the facilitylevel adjustment factors with the
proposed methodology, we ensure that
the adjustment factors reflect as
accurately as possible the costs of
providing IRF care across the full
spectrum of IRF providers where
individual providers may see an
increase or decrease. In addition,
because we update the rural and LIP
adjustments in a budget-neutral manner,
decreases to these adjustments result in
increases to the base payment rates for
all IRF providers, partially offsetting
some of the decreases in the rural and
LIP adjustment payments for the
affected providers. Thus, we believe it is
necessary to update the adjustments at
this time, using the proposed new
PO 00000
Frm 00012
Fmt 4701
Sfmt 4700
enhancement to the methodology, to
pay providers as accurately and fairly as
possible.
Comment: Several commenters did
not support our proposal to include an
indicator variable for an IRF’s
freestanding/hospital-based status in the
regression model, based on their belief
that such variables should only be
included if they are used as payment
adjusters. These commenters further
suggested that CMS pursue further
analysis to explain the fluctuations in
the teaching status adjustment factor
over time. One commenter
recommended that CMS cap the IRF
teaching status adjustment factor at the
same level as the IPPS IME adjustment,
the IPF teaching status adjustment, or
some combination of these adjustments.
Response: We appreciate the
commenters’ concerns and
recommendations. However, given that
our analysis showed large differences in
cost structures between freestanding
and hospital-based IRFs, and that a
significant amount of the differences in
costs between different types of IRFs
(for example, urban/rural, teaching/nonteaching, and high LIP percentage/low
LIP percentage) can be attributed
instead to a facility’s freestanding/
hospital-based status, we believe that
we would be remiss in not accounting
for this indicator variable in the
regression analysis. Thus, we believe
that the inclusion of the indicator
variable enables us to more precisely
and accurately calculate each of the
facility-level adjustment factors.
For several reasons, however, we do
not believe that a facility’s freestanding/
hospital-based status can be used as a
payment adjuster at this time. First, we
do not know how much of the higher
costs we observe in hospital-based IRFs
can be attributed to the actual costs of
treating patients in hospital-based
settings (versus freestanding settings)
and how much of the higher costs result
from a hospital’s decisions about
allocating costs among its different
components. Secondly, the IRF PPS has
traditionally treated freestanding IRF
hospitals and IRF units of acute care
hospitals (or CAHs) the same for
Medicare payment purposes. Thus, we
do not believe it is appropriate to
introduce a freestanding/hospital-based
payment adjuster for the IRF PPS
without substantial evidence that a
change in policy is warranted at this
time. However, we do believe that it is
necessary to recognize the important
differences in cost structures of the two
types of facilities in order to pay IRFs
as accurately and fairly as possible
under the IRF PPS.
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
As one commenter suggested, we have
done extensive analysis to uncover the
reasons for the fluctuations in the IRF
teaching status adjustment factor over
time. Our analysis shows that such
fluctuations are related primarily to the
fact that there are relatively few IRF
teaching facilities (around 110 in each
year), and therefore fluctuations in the
teaching status of one or two of these
IRFs will be evident in overall
fluctuations in the teaching adjustment
factor over time. Specifically, we found
that one IRF did not report training any
interns and residents from 2007 through
2009, then reported relatively large
intern and resident to average daily
census ratios in 2010 and 2011, and
then did not report training any interns
and residents after 2011. This one
provider appears to have contributed to
swings in the overall teaching status
adjustment factor over time. However,
we have no reason to believe that any
of the teaching status information for
this provider is incorrect, and therefore
believe that including this data is
appropriate.
Further, our analysis of the IRF
teaching adjustment trends shows no
significant cause for concern in terms of
unusually high or increasing Medicare
payments for this adjustment over time.
We found that the number of IRFs
receiving this adjustment and the
Medicare payments per IRF for this
adjustment have remained very stable
over time. Total Medicare spending for
the IRF teaching adjustment peaked at
$78 million (almost 9 percent of total
IRF PPS payments) for 124 facilities in
FY 2006, and fell to $56 million (6
percent of total IRF PPS payments) for
111 facilities in FY 2012. The average
Medicare payment to an individual IRF
for the teaching status adjustment
decreased from $773,000 in FY 2006 to
$508,000 in FY 2012. The average
number of interns and residents relative
to an IRF’s average daily census (the
factor on which an IRF’s teaching status
adjustment is based) was 0.12 in FY
2006, and declined to 0.11 in FY 2012.
Given the small magnitude of the IRF
teaching status adjustment relative to
total IRF expenditures, the lack of
growth in spending for this adjustment,
and the need to ensure that IRFs are
adequately compensated for training a
new generation of physicians in the
rehabilitation of Medicare beneficiaries
in the IRF setting, we believe that
continued funding of this adjustment is
beneficial to the Medicare program and
Medicare beneficiaries.
As one commenter suggested, we
explored the possibility of capping the
IRF teaching status adjustment at the
level of either the IPPS capital or
operating IME adjustments. However,
either of these options would decrease
the IRF teaching status adjustment
factor to such an extremely low level
(0.03 or 0.04 compared with the current
0.6876) that the additional payment per
facility would not be enough to
adequately compensate or encourage the
training of a new generation of
physicians in the rehabilitation of
Medicare beneficiaries in the IRF
setting. While capping the adjustment at
the amount currently reflected in the
inpatient psychiatric facility teaching
status adjustment (0.5150) would seem
to provide greater compensation than
capping at either the IPPS capital or
operating IME adjustment levels, at this
time there is not enough evidence to
believe that teaching costs or
compensation should be the same for
these settings. In fact, inpatient
psychiatric facilities are not similar to
IRFs in the types of patients they treat
or the types of services they provide, so
we cannot find any logical justification
for capping the IRF teaching status
adjustment factor at the teaching status
adjustment factor used in the IPF PPS.
Comment: One commenter requested
clarification on the 3-year moving
average approach, including how the
approach is used and whether or not the
47871
IRF area wage index adjustment is
included as one of the adjustments that
we estimate using this approach.
Response: The 3-year moving average
approach was implemented to decrease
year-to-year fluctuations in the facilitylevel adjustment factors. The IRF area
wage index adjustment is not included
in the facility-level adjustments that we
estimate using a 3-year moving average
approach.
Comment: Several commenters
requested more information about the
methodology used to compute the IRF
facility-level adjustments, and the data
to enable providers to replicate our
analysis. In addition, one commenter
requested that we provide the estimates
that were averaged over the 3-year
period to obtain the facility-level
adjustment factors, and that we run our
regression analysis on three years’ worth
of pooled discharge data instead of
averaging each year’s regression
coefficients over three years.
Response: Our regression analysis for
computing the IRF facility-level
adjustments was posted on the IRF PPS
Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/
Downloads/Facility-PaymentAdjustment_KJS.pdf in 2011. As we
discussed in the proposed rule, the only
change to this regression analysis would
be the addition of an indicator variable
for an IRF’s freestanding/hospital-based
status, which would equal ‘‘1’’ if the IRF
was a freestanding facility and ‘‘0’’ if the
IRF was a hospital-based facility. The
data that we used to analyze the
adjustments is available from the IRF
rate-setting files on the IRF PPS Web
site at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
InpatientRehabFacPPS/Data-Files.html.
The annual IRF facility-level adjustment
factor estimates are presented below in
Table 3. For this final rule, we averaged
the estimates for FY 2010, FY 2011, and
FY 2012.
TABLE 3—ANNUAL IRF FACILITY-LEVEL ADJUSTMENT FACTOR ESTIMATES
FY 05
tkelley on DSK3SPTVN1PROD with RULES2
LIP ....................................................................
Teaching ..........................................................
Rural .................................................................
Additionally, we investigated another
commenter’s suggestion that we reduce
the annual fluctuation in the adjustment
factors by performing the regression
analysis on three years’ worth of pooled
discharge data instead of averaging each
year’s regression coefficients over three
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
0.4172
1.5155
0.1860
FY 06
0.5107
0.6732
0.1856
FY 07
0.3865
1.0451
0.1765
FY 08
0.4898
0.4045
0.1898
years. We tried the approach that the
commenter suggested, and it did not
materially change our estimates.
Final Decision: After careful
consideration of the public comments,
we are finalizing our proposal to add an
indicator variable for a facility’s
PO 00000
Frm 00013
Fmt 4701
Sfmt 4700
FY 09
FY 10
0.4866
1.5678
0.2123
0.1594
0.3597
0.1608
FY 11
0.2702
0.6326
0.1516
FY 12
0.5538
2.6930
0.1356
freestanding/hospital-based status to the
payment regression, and, with that
change, to update the IRF facility-level
adjustment factors for FY 2014 using the
same methodology, with the exception
of adding the indicator variable, that we
used in updating the FY 2010 IRF
E:\FR\FM\06AUR2.SGM
06AUR2
47872
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
facility-level adjustment factors,
including the 3-year moving average
approach. This results in a rural
adjustment of 14.9 percent, a LIP
adjustment factor of 0.3177, and a
teaching status adjustment factor of
1.0163 for FY 2014. These updates are
effective October 1, 2013.
tkelley on DSK3SPTVN1PROD with RULES2
VI. FY 2014 IRF PPS Federal
Prospective Payment Rates
A. Market Basket Increase Factor,
Productivity Adjustment, and Other
Adjustment for FY 2014
Section 1886(j)(3)(C) of the Act
requires the Secretary to establish an
increase factor that reflects changes over
time in the prices of an appropriate mix
of goods and services included in the
covered IRF services, which is referred
to as a market basket index. According
to section 1886(j)(3)(A)(i) of the Act, the
increase factor shall be used to update
the IRF federal prospective payment
rates for each FY. Sections
1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(iii)
of the Act required the application of a
0.3 percentage point reduction to the
market basket increase factor for FY
2014. In addition, section
1886(j)(3)(C)(ii)(I) of the Act requires the
application of a productivity
adjustment, as described below. Thus,
in the FY 2014 IRF PPS proposed rule,
we proposed to update the IRF PPS
payments for FY 2014 by a market
basket increase factor based upon the
most current data available, with a
productivity adjustment as required by
section 1886(j)(3)(C)(ii)(I) of the Act as
described below and a 0.3 percentage
point reduction as required by sections
1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(iii)
of the Act.
For this final rule, we use the same
methodology described in the FY 2012
IRF PPS final rule (76 FR 47836 at
47848 through 47863) to compute the
FY 2014 market basket increase factor
and labor-related share. In that final
rule, we rebased the RPL market basket
from a 2002 base year to a 2008 base
year. Based on IHS Global Insight’s
second quarter 2013 forecast, the most
recent estimate of the 2008-based RPL
market basket increase factor for FY
2014 is 2.6 percent. IHS Global Insight
(IGI) is an economic and financial
forecasting firm that contracts with CMS
to forecast the components of providers’
market baskets.
In accordance with section
1886(j)(3)(C)(ii)(I) of the Act, and using
the methodology described in the FY
2012 IRF PPS final rule (76 FR 47836,
47858 through 47859), we apply a
productivity adjustment to the FY 2014
RPL market basket increase factor. The
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
statute defines the productivity
adjustment to be equal to the 10-year
moving average of changes in annual
economy-wide private nonfarm business
multifactor productivity (MFP) (as
projected by the Secretary for the 10year period ending with the applicable
FY cost reporting period, or other
annual period) (the ‘‘MFP adjustment’’).
The Bureau of Labor Statistics (BLS) is
the agency that publishes the official
measure of private nonfarm business
MFP. We refer readers to the BLS Web
site at https://www.bls.gov/mfp to obtain
the historical BLS-published MFP data.
The projection of MFP is currently
produced by IGI, using the methodology
described in the FY 2012 IRF PPS final
rule (76 FR 47836, 47859). The most
recent estimate of the MFP adjustment
for FY 2014 (the 10-year moving average
of MFP for the period ending FY 2014)
is 0.5 percent, which was calculated
using the methodology described in the
FY 2012 IRF PPS final rule (76 FR
47836, 47858 through 47859) and is
based on IGI’s second quarter 2013
forecast.
Thus, in accordance with section
1886(j)(3)(C) of the Act, we base the FY
2014 market basket update, which is
used to determine the applicable
percentage increase for the IRF
payments, on the most recent estimate
of the FY 2008-based RPL market basket
(currently estimated to be 2.6 percent
based on IGI’s second quarter 2013
forecast). We then reduce this
percentage increase by the current
estimate of the MFP adjustment for FY
2014 of 0.5 percentage point (the 10year moving average of MFP for the
period ending FY 2014 based on IGI’s
second quarter 2013 forecast), which
was calculated as described in the FY
2012 IRF PPS final rule (76 FR 47836,
47859). Following application of the
MFP, we further reduce the applicable
percentage increase by 0.3 percentage
point, as required by sections
1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(iii)
of the Act. Therefore, the current
estimate of the FY 2014 IRF update is
1.8 percent (2.6 percent market basket
update, less 0.5 percentage point MFP
adjustment, less 0.3 percentage point
legislative adjustment).
B. Secretary’s Final Recommendation
For FY 2014, the Medicare Payment
Advisory Commission (MedPAC)
recommends that a 0 percent update be
applied to IRF PPS payment rates. As
discussed above, and in accordance
with sections 1886(j)(3)(C) and
1886(j)(3)(D) of the Act, the Secretary is
proposing to update IRF PPS payment
rates for FY 2014 by an adjusted market
basket increase factor of 1.8 percent, as
PO 00000
Frm 00014
Fmt 4701
Sfmt 4700
section 1886(j)(3)(C) of the Act does not
provide the Secretary with the authority
to apply a different update factor to IRF
PPS payment rates for FY 2014.
We received 5 comments on the
proposed market basket increase factor,
MFP adjustment, other adjustments for
FY 2014, and the Secretary’s proposed
recommendation, which are
summarized below.
Comment: One commenter supported
our proposal to update the IRF PPS
payment rates for FY 2014 by the
adjusted market basket estimate.
Another commenter noted that MedPAC
recommended a 0 percent update for
IRFs for FY 2014, but recognized that
CMS does not have the statutory
authority to apply a different update
factor to IRF PPS payment rates than is
specified in statute. Several other
commenters expressed concerns about
the applicability of the MFP adjustment
to the IRF setting, indicating that the
unique services provided in IRFs do not
lend themselves to the efficiency gains
that are implied by the application of a
MFP adjustment. These commenters
recommended that we continue to
monitor the impact of the MFP
adjustment on IRFs and communicate
our findings to the Congress.
Response: We appreciate the
commenters’ concerns. As these
commenters noted, we are bound in
these matters by the statute. However,
we will continue to monitor the effects
of the annual updates to the IRF PPS
payment rates, and will communicate
our findings as appropriate.
Comment: One commenter expressed
concern about our use of some of the
underlying cost categories, weights, and
price proxies from the acute care
hospital data, when the necessary RPLspecific data are not available, and
suggested that we consider collecting
additional information on the IRF cost
reports prior to our next rebasing of the
RPL market basket, so that we will not
have to use the IPPS data for this
purpose anymore.
Response: As stated in the FY 2012
IRF final rule (76 FR 47836, 47851),
effective for cost reports beginning on or
after May 1, 2010, we finalized a revised
Hospital and Hospital Health Care
Complex Cost Report, Form CMS 2552–
10, which includes a new worksheet
(Worksheet S–3, part V) which
identifies the contract labor costs and
benefit costs for the hospital complex
and is applicable to sub-providers and
units. Prior to any future rebasings, we
plan to review any contract labor and
benefit cost data submitted by RPL
providers to determine the
appropriateness of using this
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
information in the derivation of updated
market basket cost weights.
Final Decision: After careful
consideration of the public comments,
we are finalizing our decision to update
IRF PPS payment rates for FY 2014
based on the most recent estimate of the
FY 2008-based RPL market basket
(currently estimated to be 2.6 percent
based on IGI’s second quarter 2013
forecast). We then reduce this
percentage increase by the current
estimate of the MFP adjustment for FY
2014 of 0.5 percentage point (the 10year moving average of MFP for the
period ending FY 2014 based on IGI’s
second quarter 2013 forecast), which
was calculated as described in the FY
2012 IRF PPS final rule (76 FR 47836,
47859). Following application of the
MFP adjustment, we further reduce the
applicable percentage increase by 0.3
percentage point, as required by
sections 1886(j)(3)(C)(ii)(II) and
1886(j)(3)(D)(iii) of the Act. Therefore,
the FY 2014 IRF update is 1.8 percent
(2.6 percent market basket update, less
0.5 percentage point MFP adjustment,
less 0.3 percentage point legislative
adjustment).
47873
C. Labor-Related Share for FY 2014
The labor-related share for FY 2014 is
updated using the methodology
described in the FY 2012 IRF PPS final
rule (76 FR 47836, 47860 through
47863). Using this method and IGI’s
second quarter 2013 forecast of the
2008-based RPL market basket, the IRF
labor-related share for FY 2014 is the
sum of the FY 2014 relative importance
of each labor-related cost category. This
figure reflects the different rates of price
change for these cost categories between
the base year (FY 2008) and FY 2014. As
shown in Table 4, the FY 2014 laborrelated share is 69.494 percent.
TABLE 4—FY 2014 IRF RPL LABOR-RELATED SHARE RELATIVE IMPORTANCE
FY 2014 Relative
importance laborrelated share
Wages and Salaries ......................................................................................................................................................................
Employee Benefits .........................................................................................................................................................................
Professional Fees: Labor-Related .................................................................................................................................................
Administrative and Business Support Services .............................................................................................................................
All Other: Labor-Related Services .................................................................................................................................................
Subtotal ..........................................................................................................................................................................................
Labor-Related Portion of Capital Costs (.46) ................................................................................................................................
48.394
12.963
2.065
0.415
2.080
65.917
3.577
Total Labor-Related Share .....................................................................................................................................................
69.494
tkelley on DSK3SPTVN1PROD with RULES2
Source: IHS Global Insight, Inc. 2nd quarter 2013 forecast; Historical Data through 1st quarter, 2013.
We received 1 comment on the
proposed update to the IRF labor-related
share, which is summarized below.
Comment: One commenter expressed
general concern with the proposed
decrease in the IRF labor-related share
from FY 2013 to FY 2014.
Response: We believe that the
methodology for determining the laborrelated share is technically appropriate,
as it estimates the proportion of IRF
costs that are labor-intensive and vary
with, or are influenced by, the local
labor market. The methodology for
determining the proposed IRF laborrelated share for FY 2014 is the same
general method that was used to derive
the FY 2013 IRF PPS labor-related share.
That is, the labor-related share is equal
to the sum of the relative importance of
each labor-related cost category in the
RPL market basket. We calculate the
labor-related relative importance for FY
2014 in four steps. First, we compute
the FY 2014 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 2014 price
index level for that cost category by the
total market basket price index level.
Third, we determine the FY 2014
relative importance for each cost
category by multiplying this ratio by the
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
base year (FY 2008) weight. Finally, we
add the FY 2014 relative importance for
each of the labor-related cost categories.
The purpose of the relative importance
is to capture the different rates of price
change for each of the market basket
cost categories between the base year
(FY 2008 for IRFs) and FY 2014.
Therefore, to the extent an individual
price proxy for a specific cost category
is projected to grow faster from FY 2008
to FY 2014 relative to the proxies for
other cost categories, the relative
importance for that category in FY 2014
will be higher than the base year cost
weight in FY 2008.
Final Decision: After consideration of
the public comments received, we are
finalizing our decision to update IRF
labor-related share for FY 2014 using
the methodology described in the FY
2012 IRF PPS final rule (76 FR 47836,
47860 through 47863) and IGI’s second
quarter 2013 forecast of the 2008-based
RPL market basket. The FY 2014 laborrelated share is 69.494 percent.
D. Wage Adjustment
Section 1886(j)(6) of the Act requires
the Secretary to adjust the proportion of
rehabilitation facilities’ costs
attributable to wages and wage related
costs (as estimated by the Secretary from
time to time) by a factor (established by
the Secretary) reflecting the relative
PO 00000
Frm 00015
Fmt 4701
Sfmt 4700
hospital wage level in the geographic
area of the rehabilitation facility
compared to the national average wage
level for those facilities. The Secretary
is required to update the IRF PPS wage
index on the basis of information
available to the Secretary on the wages
and wage-related costs to furnish
rehabilitation services. Any adjustment
or updates made under section
1886(j)(6) of the Act for a FY are made
in a budget-neutral manner.
For FY 2014, we are maintaining the
policies and methodologies described in
the FY 2012 IRF PPS final rule (76 FR
47836, at 47863 through 47865) relating
to the labor market area definitions and
the wage index methodology for areas
with wage data. Thus, we are using the
CBSA labor market area definitions and
the FY 2013 pre-reclassification and
pre-floor hospital wage index data. In
accordance with section 1886(d)(3)(E) of
the Act, the FY 2013 pre-reclassification
and pre-floor hospital wage index is
based on data submitted for hospital
cost reporting periods beginning on or
after October 1, 2008, and before
October 1, 2009 (that is, FY 2009 cost
report data).
The labor market designations made
by the OMB include some geographic
areas where there are no hospitals and,
thus, no hospital wage index data on
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47874
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
which to base the calculation of the IRF
PPS wage index. We will continue to
use the same methodology discussed in
the FY 2008 IRF PPS final rule (72 FR
44299) to address those geographic areas
where there are no hospitals and, thus,
no hospital wage index data in which to
base the calculation for the FY 2014 IRF
PPS wage index.
In accordance with our established
methodology, we have historically
adopted any CBSA changes that are
published in the OMB bulletin that
corresponds with the hospital wage data
used to determine the IRF PPS wage
index. The OMB bulletins are available
at https://www.whitehouse.gov/omb/
bulletins/.
In keeping with the established IRF
PPS wage index policy, we will use the
prior year’s (FY 2013) pre-floor, prereclassified hospital wage index data to
derive the FY 2014 applicable IRF PPS
wage index. We anticipate using the FY
2014 pre-floor, pre-reclassified hospital
wage index data to derive the applicable
IRF PPS wage index for FY 2015. We
note, however, that the FY 2014 prefloor, pre-reclassified hospital wage
index does not use OMB’s new 2010
Census-based area delineations, which
were outlined in the February 28, 2013
OMB Bulletin 13–01. This bulletin
contains a number of significant
changes. For example, there are new
CBSAs, counties that change from urban
to rural, counties that change from rural
to urban, and existing CBSAs that are
being split apart. The OMB Bulletin
with these changes was not published in
time for incorporation into the FY 2014
pre-floor, pre-reclassified hospital wage
index, since the proposed rule was
already in the advanced stages of
development at that time and the
changes and their ramifications would
need to be extensively reviewed and
verified prior to their inclusion in the
rule. We therefore intend to consider the
incorporation of these CBSA changes
during the development of the FY 2015
hospital wage index. Assuming that we
would continue to follow our
established methodology for the IRF
PPS wage index, this means that the
2010 Census-based CBSA changes
would not be considered for inclusion
in the IRF PPS wage index until FY
2016.
To calculate the wage-adjusted facility
payment for the payment rates set forth
in this final rule, we multiply the
unadjusted Federal payment rate for
IRFs by the FY 2014 labor-related share
based on the FY 2008-based RPL market
basket (69.494 percent) to determine the
labor-related portion of the standard
payment amount. We then multiply the
labor-related portion by the applicable
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
IRF wage index from the tables in the
addendum to this final rule. These
tables are available through the Internet
on the CMS Web site at https://
www.cms.hhs.gov/Medicare/MedicareFee-for-Service-Payment/
InpatientRehabFacPPS/. Table A is for
urban areas, and Table B is for rural
areas.
Adjustments or updates to the IRF
wage index made under section
1886(j)(6) of the Act must be made in a
budget-neutral manner. We calculate a
budget-neutral wage adjustment factor
as established in the FY 2004 IRF PPS
final rule (68 FR 45689), codified at
§ 412.624(e)(1), as described in the steps
below. We use the listed steps to ensure
that the FY 2014 IRF standard payment
conversion factor reflects the update to
the wage indexes (based on the FY 2009
hospital cost report data) and the laborrelated share in a budget-neutral
manner:
Step 1. Determine the total amount of
the estimated FY 2013 IRF PPS rates,
using the FY 2013 standard payment
conversion factor and the labor-related
share and the wage indexes from FY
2013 (as published in the July 30, 2012
FY 2013 IRF PPS notice (77 FR 44618)).
Step 2. Calculate the total amount of
estimated IRF PPS payments using the
FY 2013 standard payment conversion
factor and the FY 2014 labor-related
share and CBSA urban and rural wage
indexes.
Step 3. Divide the amount calculated
in step 1 by the amount calculated in
step 2. The resulting quotient is the FY
2014 budget-neutral wage adjustment
factor of 1.0010.
Step 4. Apply the FY 2014 budgetneutral wage adjustment factor from
step 3 to the FY 2013 IRF PPS standard
payment conversion factor after the
application of the adjusted market
basket update to determine the FY 2014
standard payment conversion factor.
We received 3 comments on the
proposed FY 2014 IRF PPS wage index,
which are summarized below.
Comment: Several commenters
recommended that we develop a new
methodology for area wage adjustment
that eliminates hospital wage index
reclassifications for all hospitals and
reduces the problems associated with
annual fluctuations in wage indices and
across geographic boundaries. These
commenters also recommended that we
consider wage index policies under the
current IPPS because IRFs compete in a
similar labor pool as acute care
hospitals. The commenters suggested
that the IPPS wage index policies would
allow IRFs to benefit from the IPPS
reclassification and/or floor policies.
The commenters further recommended
PO 00000
Frm 00016
Fmt 4701
Sfmt 4700
that until a new wage index system is
implemented, we institute a
‘‘smoothing’’ variable to the current
process to reduce the fluctuations IRFs
annually experience.
Response: We note that the IRF PPS
does not account for geographic
reclassification under sections
1886(d)(8) and (d)(10) of the Act, and
does not apply the ‘‘rural floor’’ under
section 4410 of Public Law 105–33
(BBA). Furthermore, as we do not have
an IRF-specific wage index, we are
unable to determine at this time the
degree, if any, to which a geographic
reclassification adjustment or a ‘‘rural
floor’’ policy under the IRF PPS would
be appropriate. The rationale for our
current wage index policies is fully
described in the FY 2006 final rule (70
FR 47880, 47926 through 47928).
Finally, although some commenters
recommended that we adopt the IPPS
wage index policies such as
reclassification and floor policies, we
note that the Medicare Payment
Advisory Commission (MedPAC’s) June
2007 report to the Congress, titled
‘‘Report to Congress: Promoting Greater
Efficiency in Medicare,’’ recommends
that Congress ‘‘repeal the existing
hospital wage index statute, including
reclassification and exceptions, and give
the Secretary authority to establish new
wage index systems.’’ We continue to
believe that adopting the IPPS wage
index policies, such as reclassification
or floor, would not be prudent at this
time because MedPAC suggests that the
reclassification and exception policies
in the IPPS wage index alter the wage
index values for one-third of IPPS
hospitals. As one commenter noted, we
have research currently under way to
examine alternatives to the wage index
methodology, including the issues the
commenters mentioned about ensuring
that the wage index minimizes
fluctuations, matches the costs of labor
in the market, and provides for a single
wage index policy. Section 3137(b) of
the Affordable Care Act required us to
submit a report to the Congress by
December 31, 2011 that includes a plan
to reform the hospital wage index
system. The report that we submitted is
available online at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/WageIndex-Reform.html.
We enlisted the help of Acumen, LLC
to assist us in meeting the requirements
of section 106(b)(2), Division B, Title I
of the Tax Relief and Health Care Act of
2006 (Pub. L. 109–432, enacted on
December 20, 2006) (TRCA). Acumen,
LLC conducted a study of both the
current methodology used to construct
the Medicare wage index and the
E:\FR\FM\06AUR2.SGM
06AUR2
47875
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
We plan to monitor the efforts to
develop an alternative wage index
system for the IPPS closely and
determine the impact or influence they
may have on the IRF PPS wage index.
Final Decision: After consideration of
the public comments received, we have
decided to continue to use the policies
and methodologies described in the FY
2008 IRF PPS final rule relating to the
wage index methodology for areas
without wage data. For FY 2014, we are
maintaining the policies and
methodologies described in the FY 2012
IRF PPS final rule (76 FR 47836, at
47836 through 47865) relating to the
labor market area definitions and the
wage index methodology for areas with
wage data. Therefore, this final rule
continues to use the Core-Based
Statistical Area (CBSA) labor market
area definitions and the prereclassification and pre-floor hospital
wage index data based on 2009 cost
report data. However, we will continue
to monitor the IPPS wage index to
identify any policy changes that may be
appropriate for IRFs.
We discuss the calculation of the
standard payment conversion factor for
FY 2014 in section VI.E. of this final
rule.
recommendations reported to Congress
by MedPAC. Parts 1 and 2 of Acumen’s
final report, which analyzes the
strengths and weaknesses of the data
sources used to construct the CMS and
MedPAC indexes, is available online at
https://www.acumenllc.com/reports/cms.
The report took MedPAC’s 2009
recommendations on the Medicare wage
index classification system into account,
and includes a proposal to revise the
IPPS wage index system. MedPAC’s
recommendations were noted in the FY
2009 IPPS final rule (75 FR 48434 at
48563). The proposal considered each of
the following:
• The use of Bureau of Labor
Statistics data or other data or
methodologies to calculate relative
wages for each geographic area.
• Minimizing variations in wage
index adjustments between and within
MSAs and statewide rural areas.
• Methods to minimize the volatility
of wage index adjustments while
maintaining the principle of budget
neutrality.
• The effect that the implementation
of the proposal would have on health
care providers in each region of the
county.
• Issues relating to occupational mix,
such as staffing practices and any
evidence on quality of care and patient
safety, including any recommendations
for alternative calculations to the
occupational mix.
• The provision of a transition period.
E. Description of the IRF Standard
Conversion Factor and Payment Rates
for FY 2014
To calculate the standard payment
conversion factor for FY 2014, as
illustrated in Table 5, we begin by
applying the adjusted market basket
increase factor for FY 2014 that was
adjusted in accordance with sections
1886(j)(3)(C) and (D) of the Act, to the
standard payment conversion factor for
FY 2013 ($14,343). Applying the 1.8
percent adjusted market basket increase
factor for FY 2014 to the revised
standard payment conversion factor for
FY 2013 of $14,343 yields a standard
payment amount of $14,601. Then, we
apply the budget neutrality factor for the
FY 2014 wage index and labor-related
share of 1.0010, which results in a
standard payment amount of $14,616.
We next apply the budget neutrality
factors for the revised CMG relative
weights of 1.0000, which results in a
standard payment conversion factor of
$14,616 for FY 2014.
We then apply the budget neutrality
factors for the facility adjustments.
Applying the budget neutrality factor for
the revised rural adjustment of 1.0025
results in a standard payment
conversion factor of $14,652. We then
apply the budget neutrality factor for the
revised LIP adjustment of 1.0171
resulting in a standard payment
conversion factor of $14,903. Lastly, we
apply the budget neutrality factor for the
revised teaching adjustment of 0.9962
which results in a final standard
payment conversion factor for FY 2014
of $14,846.
TABLE 5—CALCULATIONS TO DETERMINE THE FY 2014 STANDARD PAYMENT CONVERSION FACTOR
Explanation for adjustment
Calculations
Standard Payment Conversion Factor for FY 2013 ....................................................................................................................
Market Basket Increase Factor for FY 2014 (2.6 percent), reduced by 0.3 percentage point in accordance with sections
1886(j)(3)(C) and (D) of the Act and a 0.5 percentage point reduction for the productivity adjustment as required by section 1886(j)(3)(C)(ii)(I) of the Act ..............................................................................................................................................
Budget Neutrality Factor for the Wage Index and Labor-Related Share ....................................................................................
Budget Neutrality Factor for the Revisions to the CMG Relative Weights .................................................................................
Budget Neutrality Factor for the Update to the Rural Adjustment Factor ...................................................................................
Budget Neutrality Factor for the Update to the LIP Adjustment Factor ......................................................................................
Budget Neutrality Factor for the Update to the Teaching Status Adjustment Factor .................................................................
FY 2014 Standard Payment Conversion Factor .........................................................................................................................
After the application of the CMG
relative weights described in Section IV
of this final rule, to the FY 2014
standard payment conversion factor
($14,846), the resulting unadjusted IRF
$14,343
×
×
×
×
×
×
=
1.018
1.0010
1.0000
1.0025
1.0171
0.9962
$14,846
prospective payment rates for FY 2014
are shown in Table 6.
TABLE 6—FY 2014 PAYMENT RATES
tkelley on DSK3SPTVN1PROD with RULES2
CMG
0101
0102
0103
0104
0105
0106
0107
0108
Payment rate Tier 1
.................
.................
.................
.................
.................
.................
.................
.................
VerDate Mar<15>2010
19:58 Aug 05, 2013
Payment rate Tier 2
$11,851.56
14,713.87
17,233.24
18,129.94
21,192.67
24,176.71
27,294.37
34,378.88
Jkt 229001
PO 00000
$10,616.37
13,180.28
15,436.87
16,240.04
18,983.58
21,657.34
24,448.39
30,795.06
Frm 00017
Fmt 4701
Sfmt 4700
Payment rate Tier 3
$9,707.80
12,051.98
14,115.58
14,848.97
17,357.94
19,803.08
22,356.59
28,158.41
E:\FR\FM\06AUR2.SGM
06AUR2
Payment rate no comorbidity
$9,262.42
11,498.23
13,466.81
14,167.54
16,560.71
18,893.02
21,329.25
26,865.32
47876
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
TABLE 6—FY 2014 PAYMENT RATES—Continued
tkelley on DSK3SPTVN1PROD with RULES2
CMG
0109
0110
0201
0202
0203
0204
0205
0206
0207
0301
0302
0303
0304
0401
0402
0403
0404
0405
0501
0502
0503
0504
0505
0506
0601
0602
0603
0604
0701
0702
0703
0704
0801
0802
0803
0804
0805
0806
0901
0902
0903
0904
1001
1002
1003
1101
1102
1201
1202
1203
1301
1302
1303
1401
1402
1403
1404
1501
1502
1503
1504
1601
1602
1603
1701
1702
1703
1704
1801
1802
1803
1901
Payment rate Tier 1
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
VerDate Mar<15>2010
19:58 Aug 05, 2013
Payment rate Tier 2
31,161.75
40,651.32
12,250.92
15,661.05
18,587.19
19,414.11
23,443.32
28,908.13
38,253.69
16,306.85
20,420.67
24,078.73
32,352.40
16,838.33
20,975.91
34,375.91
63,147.46
51,949.12
12,446.89
16,464.21
21,280.26
24,592.40
29,258.50
40,853.22
14,318.97
19,261.20
24,092.09
32,190.58
13,909.22
18,011.17
21,884.49
27,785.77
10,447.13
13,739.97
18,689.63
16,536.96
20,419.19
24,767.58
13,376.25
17,935.45
22,387.77
29,200.60
15,255.75
19,414.11
28,744.83
18,110.64
25,408.93
14,035.41
17,442.57
21,789.47
17,337.16
22,306.12
28,584.49
13,166.92
17,708.31
21,646.95
27,594.26
15,036.03
18,781.67
22,799.00
28,292.02
15,895.61
20,619.61
26,078.48
16,409.28
20,643.36
24,574.58
31,184.02
16,891.78
25,992.38
41,528.72
16,087.13
Jkt 229001
PO 00000
27,913.45
36,412.78
10,322.42
13,196.61
15,662.53
16,360.29
19,755.57
24,360.80
32,235.12
14,033.92
17,574.69
20,722.05
27,843.67
13,995.32
17,435.14
28,572.61
52,488.03
43,181.08
9,779.06
12,933.84
16,718.08
19,320.58
22,986.06
32,095.57
11,624.42
15,637.29
19,558.12
26,133.41
11,869.38
15,370.06
18,674.78
23,710.55
9,194.13
12,092.07
16,446.40
14,553.53
17,969.60
21,796.90
11,063.24
14,834.12
18,515.93
24,151.47
13,873.59
17,654.86
26,140.84
16,563.68
23,236.96
13,971.57
17,362.40
21,688.52
14,807.40
19,050.39
24,412.76
10,782.65
14,501.57
17,727.61
22,598.58
12,819.52
16,014.38
19,439.35
24,121.78
13,187.70
17,107.05
21,635.08
14,179.41
17,838.95
21,235.72
26,948.46
15,117.68
23,262.20
37,166.96
13,788.96
Frm 00018
Fmt 4701
Sfmt 4700
Payment rate Tier 3
25,523.24
33,295.12
9,177.80
11,734.28
13,925.55
14,546.11
17,564.30
21,658.83
28,660.20
12,573.08
15,745.67
18,566.41
24,945.73
13,031.82
16,235.59
26,605.52
48,874.52
40,207.42
9,216.40
12,190.05
15,756.06
18,208.62
21,663.28
30,248.73
10,729.20
14,431.80
18,051.25
24,118.81
11,354.22
14,703.48
17,864.19
22,681.72
8,413.23
11,066.21
15,050.87
13,318.35
16,444.91
19,945.60
10,230.38
13,719.19
17,123.38
22,335.81
11,910.95
15,157.77
22,442.70
15,294.35
21,458.41
12,537.45
15,580.88
19,463.11
13,453.45
17,308.95
22,181.41
9,731.55
13,088.23
15,999.53
20,395.43
11,584.33
14,470.40
17,565.79
21,798.38
12,362.26
16,036.65
20,282.61
12,795.77
16,097.52
19,163.22
24,317.75
13,682.07
21,054.60
33,639.55
13,134.26
E:\FR\FM\06AUR2.SGM
06AUR2
Payment rate no comorbidity
24,351.89
31,767.47
8,546.84
10,926.66
12,967.98
13,545.49
16,355.84
20,168.29
26,688.65
11,627.39
14,560.96
17,169.40
23,069.20
11,652.63
14,516.42
23,789.23
43,700.69
35,951.07
8,392.44
11,100.35
14,347.17
16,580.01
19,725.88
27,543.78
9,725.61
13,080.81
16,361.78
21,862.22
10,310.55
13,351.01
16,222.22
20,597.34
7,699.14
10,126.46
13,772.63
12,187.08
15,047.91
18,251.67
9,265.39
12,424.62
15,508.13
20,229.16
11,011.28
14,013.14
20,747.29
14,929.14
20,943.25
11,467.05
14,250.68
17,801.84
12,201.93
15,699.65
20,117.81
8,814.07
11,854.53
14,491.18
18,472.88
11,095.90
13,860.23
16,824.97
20,877.93
11,340.86
14,710.90
18,606.49
11,533.86
14,510.48
17,273.32
21,918.63
11,354.22
17,472.26
27,916.42
12,939.77
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
47877
TABLE 6—FY 2014 PAYMENT RATES—Continued
CMG
1902
1903
2001
2002
2003
2004
2101
5001
5101
5102
5103
5104
Payment rate Tier 1
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
Payment rate Tier 2
Payment rate Tier 3
31,559.63
52,455.37
13,178.79
17,617.75
22,190.32
29,113.01
32,591.42
................................................
................................................
................................................
................................................
................................................
27,050.90
44,964.08
10,788.59
14,421.40
18,164.08
23,829.31
23,195.39
................................................
................................................
................................................
................................................
................................................
25,765.23
42,824.77
9,933.46
13,279.75
16,725.50
21,942.39
22,433.79
................................................
................................................
................................................
................................................
................................................
in a LIP adjustment of 1.0454 percent), a
wage index of 0.8862, and a teaching status
adjustment of 0.0784.
F. Example of the Methodology for
Adjusting the Federal Prospective
Payment Rates
Table 7 illustrates the methodology
for adjusting the federal prospective
payments (as described in sections VI.A.
through VI.D. of this final rule). The
following examples are based on two
hypothetical Medicare beneficiaries,
both classified into CMG 0110 (without
comorbidities). The unadjusted federal
prospective payment rate for CMG 0110
(without comorbidities) appears in
Table 6.
Example: One beneficiary is in Facility A,
an IRF located in rural Spencer County,
Indiana, and another beneficiary is in Facility
B, an IRF located in urban Harrison County,
Indiana. Facility A, a rural non-teaching
hospital has a Disproportionate Share
Hospital (DSH) percentage of 5 percent
(which would result in a LIP adjustment of
1.0156), a wage index of 0.8472, and a rural
adjustment of 14.9 percent. Facility B, an
urban teaching hospital, has a DSH
percentage of 15 percent (which would result
To calculate each IRF’s labor and nonlabor portion of the Federal prospective
payment, we begin by taking the
unadjusted Federal prospective
payment rate for CMG 0110 (without
comorbidities) from Table 6. Then, we
multiply the labor-related share for FY
2014 (69.494 percent) described in
section VI.C. of this final rule by the
unadjusted federal prospective payment
rate. To determine the non-labor portion
of the federal prospective payment rate,
we subtract the labor portion of the
federal payment from the unadjusted
Federal prospective payment.
To compute the wage-adjusted federal
prospective payment, we multiply the
labor portion of the federal payment by
the appropriate wage index found in
tables A and B. These tables are
available through the Internet on the
CMS Web site at https://
www.cms.hhs.gov/Medicare/Medicare-
Payment rate no comorbidity
25,382.21
42,189.36
9,066.45
12,120.27
15,266.14
20,027.25
21,001.15
2,283.31
9,823.60
21,298.07
11,361.64
29,224.35
Fee-for-Service-Payment/Inpatient
RehabFacPPS/. The resulting figure is
the wage-adjusted labor amount. Next,
we compute the wage-adjusted federal
payment by adding the wage-adjusted
labor amount to the non-labor portion.
Adjusting the wage-adjusted federal
payment by the facility-level
adjustments involves several steps.
First, we take the wage-adjusted Federal
prospective payment and multiply it by
the appropriate rural and LIP
adjustments (if applicable). Second, to
determine the appropriate amount of
additional payment for the teaching
status adjustment (if applicable), we
multiply the teaching status adjustment
(0.0784, in this example) by the wageadjusted and rural-adjusted amount (if
applicable). Finally, we add the
additional teaching status payments (if
applicable) to the wage, rural, and LIPadjusted federal prospective payment
rates. Table 7 illustrates the components
of the adjusted payment calculation.
TABLE 7—EXAMPLE OF COMPUTING THE IRF FY 2014 FEDERAL PROSPECTIVE PAYMENT
tkelley on DSK3SPTVN1PROD with RULES2
Steps
1 ..................
2 ..................
3 ..................
4 ..................
5 ..................
6 ..................
7 ..................
8 ..................
9 ..................
10 ................
11 ................
12 ................
13 ................
14 ................
15 ................
16 ................
Rural facility A
(Spencer Co., IN)
Unadjusted Federal Prospective Payment .....................................................................
Labor Share ....................................................................................................................
Labor Portion of Federal Payment .................................................................................
CBSA Based Wage Index (shown in the Addendum, Tables 1 and 2) .........................
Wage-Adjusted Amount .................................................................................................
Non-labor Amount ..........................................................................................................
Wage-Adjusted Federal Payment ..................................................................................
Rural Adjustment ............................................................................................................
Wage- and Rural-Adjusted Federal Payment ................................................................
LIP Adjustment ...............................................................................................................
FY 2014 Wage-, Rural- and LIP-Adjusted Federal Prospective Payment Rate ............
FY 2014 Wage- and Rural-Adjusted Federal Prospective Payment .............................
Teaching Status Adjustment ..........................................................................................
Teaching Status Adjustment Amount .............................................................................
FY 2014 Wage-, Rural-, and LIP-Adjusted Federal Prospective Payment Rate ...........
Total FY 2014 Adjusted Federal Prospective Payment .................................................
Thus, the adjusted payment for
Facility A would be $33,142.51, and the
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
adjusted payment for Facility B would
be $32,876.96.
PO 00000
Frm 00019
Fmt 4701
Sfmt 4700
×
=
×
=
+
=
×
=
×
=
×
=
+
=
$31,767.47
0.69494
$22,076.49
0.8472
$18,703.20
$9,690.98
$28,394.18
1.1493
$32,633.43
1.0156
$33,142.51
$32,633.43
0
$0.00
$33,142.51
$33,142.51
Urban facility B
(Harrison Co., IN)
×
=
×
=
+
=
×
=
×
=
×
=
+
=
$31,767.47
0.69494
$22,076.49
0.8862
$19,564.19
$9,690.98
$29,255.17
1.000
$29,255.17
1.0454
$30,583.35
$29,255.17
0.0784
$2,293.61
$30,583.35
$32,876.96
We did not receive any comments
specifically on the FY 2014 IRF PPS
Federal prospective payment rates.
E:\FR\FM\06AUR2.SGM
06AUR2
47878
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
VII. Update to Payments for High-Cost
Outliers Under the IRF PPS
A. Update to the Outlier Threshold
Amount for FY 2014
Section 1886(j)(4) of the Act provides
the Secretary with the authority to make
payments in addition to the basic IRF
prospective payments for cases
incurring extraordinarily high costs. A
case qualifies for an outlier payment if
the estimated cost of the case exceeds
the adjusted outlier threshold. We
calculate the adjusted outlier threshold
by adding the IRF PPS payment for the
case (that is, the CMG payment adjusted
by all of the relevant facility-level
adjustments) and the adjusted threshold
amount (also adjusted by all of the
relevant facility-level adjustments).
Then, we calculate the estimated cost of
a case by multiplying the IRF’s overall
CCR by the Medicare allowable covered
charge. If the estimated cost of the case
is higher than the adjusted outlier
threshold, we make an outlier payment
for the case equal to 80 percent of the
difference between the estimated cost of
the case and the outlier threshold.
In the FY 2002 IRF PPS final rule (66
FR 41362 through 41363), we discussed
our rationale for setting the outlier
threshold amount for the IRF PPS so
that estimated outlier payments would
equal 3 percent of total estimated
payments. For the 2002 IRF PPS final
rule, we analyzed various outlier
policies using 3, 4, and 5 percent of the
total estimated payments, and we
concluded that an outlier policy set at
3 percent of total estimated payments
would optimize the extent to which we
could reduce the financial risk to IRFs
of caring for high-cost patients, while
still providing for adequate payments
for all other (non-high cost outlier)
cases.
Subsequently, we updated the IRF
outlier threshold amount in the FYs
2006 through 2012 IRF PPS final rules
and the FY 2011 and FY 2013 notices
(70 FR 47880, 71 FR 48354, 72 FR
44284, 73 FR 46370, 74 FR 39762, 75 FR
42836, 76 FR 47836, 76 FR 59256, and
77 FR 44618, respectively) to maintain
estimated outlier payments at 3 percent
of total estimated payments. We also
stated in the FY 2009 final rule (73 FR
46370 at 46385) that we would continue
to analyze the estimated outlier
payments for subsequent years and
adjust the outlier threshold amount as
appropriate to maintain the 3 percent
target.
To update the IRF outlier threshold
amount for FY 2014, we proposed to use
FY 2012 claims data and the same
methodology that we used to set the
initial outlier threshold amount in the
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
FY 2002 IRF PPS final rule (66 FR 41316
and 41362 through 41363), which is also
the same methodology that we used to
update the outlier threshold amounts for
FYs 2006 through 2013. Based on an
analysis of this updated data, we
estimate that IRF outlier payments as a
percentage of total estimated payments
are approximately 2.5 percent in FY
2014. This estimated percentage
changed more than usual between the
proposed rule and the final rule due to
the use of updated data for the final rule
(from 2.8 percent in the proposed rule
to 2.5 percent in the final rule). Our
analysis indicates that this change was
due to a larger-than-usual change in
individual IRFs’ CCRs between the
proposed rule and the final rule. This
may be the result of outlier
reconciliation policies that we recently
implemented for the IRF PPS that result
in more current CCRs being used to
calculate the outlier payments. Based on
our updated estimates, then, we update
the outlier threshold amount to $9,272
to maintain estimated outlier payments
at approximately 3 percent of total
estimated aggregate IRF payments for
FY 2014.
We received 4 comments on the
update to the outlier threshold amount
for FY 2014, which are summarized
below.
Comment: Several commenters
expressed support for the proposed
update to the outlier threshold amount
to maintain estimated IRF outlier
payments for FY 2014 at 3 percent of
total IRF PPS payments. However,
several other commenters expressed
concerns that actual IRF outlier
payments in recent years have tended to
fall below 3 percent of total IRF PPS
payments. These commenters requested
that we evaluate the IRF PPS outlier
policy to ensure that it is working as
intended, adopt similar changes in the
IRF PPS outlier calculation that are
proposed for the FY 2014 IPPS outlier
calculation, and incorporate any unused
outlier payments from years in which
aggregate outlier payments are below
the 3 percent target back into the IRF
PPS base payments for subsequent
years. One commenter also suggested
that we lower the outlier pool from 3
percent to 1.5 or 2 percent, and add the
money back into the IRF PPS base
payment amount.
Response: We will continue to
monitor our IRF outlier policies to
ensure that they continue to compensate
IRFs for treating unusually high-cost
patients and, thereby, promote access to
care for patients who are likely to
require unusually high-cost care. At this
time, we do not have any indications to
suggest that the outlier pool would be
PO 00000
Frm 00020
Fmt 4701
Sfmt 4700
better set at 1.5 or 2 percent than at 3
percent.
We do not make adjustments to IRF
PPS payment rates for the sole purpose
of accounting for differences between
projected and actual outlier payments.
We use the best available data at the
time to establish an outlier threshold for
IRF PPS payments prior to the
beginning of each fiscal year so that
estimated outlier payments for that
fiscal year will equal 3 percent of total
estimated total IRF PPS payments. We
evaluate the status of our outlier
expenditures annually and if there is a
difference from our projection, that
information is used to make a
prospective adjustment to lower or raise
the outlier threshold for the upcoming
fiscal year. We do not make
retrospective adjustments. If outlier
payments for a given year turn out to be
greater than projected, we do not recoup
money from hospitals; if outlier
payments for a given year are lower than
projected, we do not make an
adjustment to account for the difference.
Payments for a given discharge in a
given fiscal year are generally intended
to reflect or address the average costs of
that discharge in that year; that goal
would be undermined if we adjusted
IRF PPS payments to account for
‘‘underpayments’’ or ‘‘overpayments’’ in
IRF outliers in previous years.
We also note that the IPPS outlier
payments are not calculated using the
same methodology as the IRF PPS
outlier calculations, so recently
implemented and proposed changes to
the IPPS methodology for calculating
outlier payments would not be
applicable for the IRF PPS unless we
were to change our entire methodology
for calculating IRF outlier payments to
mirror the IPPS methodology, which we
are not considering at this time.
Final Decision: Having carefully
considered the public comments
received, we are reducing the outlier
threshold amount to $9,272 to maintain
estimated outlier payments at 3 percent
of total estimated aggregate IRF
payments for FY 2014. This update is
effective October 1, 2013. We will
continue to monitor trends in IRF
outlier payments to ensure that they are
working as intended to compensate IRFs
for treating exceptionally high-cost IRF
patients.
B. Update to the IRF Cost-to-Charge
Ratio Ceiling and Urban/Rural Averages
In accordance with the methodology
stated in the FY 2004 IRF PPS final rule
(68 FR 45674, 45692 through 45694), we
apply a ceiling to IRFs’ CCRs. Using the
methodology described in that final
rule, we update the national urban and
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
rural CCRs for IRFs, as well as the
national CCR ceiling for FY 2014, based
on analysis of the most recent data that
is available. We apply the national
urban and rural CCRs in the following
situations:
• New IRFs that have not yet
submitted their first Medicare cost
report.
• IRFs whose overall CCR is in excess
of the national CCR ceiling for FY 2014,
as discussed below.
• Other IRFs for which accurate data
to calculate an overall CCR are not
available.
Specifically, for FY 2014, we estimate
a national average CCR of 0.643 for rural
IRFs, which we calculate by taking an
average of the CCRs for all rural IRFs
using their most recently submitted cost
report data. Similarly, we estimate a
national average CCR of 0.516 for urban
IRFs, which we calculate by taking an
average of the CCRs for all urban IRFs
using their most recently submitted cost
report data. We apply weights to both of
these averages using the IRFs’ estimated
costs, meaning that the CCRs of IRFs
with higher costs factor more heavily
into the averages than the CCRs of IRFs
with lower costs. For this final rule, we
have used the most recent available cost
report data (FY 2011). This includes all
IRFs whose cost reporting periods begin
on or after October 1, 2010, and before
October 1, 2011. If, for any IRF, the FY
2011 cost report was missing or had an
‘‘as submitted’’ status, we used data
from a previous fiscal year’s (that is, FY
2004 through FY 2010) settled cost
report for that IRF. We do not use cost
report data from before FY 2004 for any
IRF because changes in IRF utilization
since FY 2004 resulting from the 60
percent rule and IRF medical review
activities suggest that these older data
do not adequately reflect the current
cost of care.
In accordance with past practice, we
will set the national CCR ceiling at 3
standard deviations above the mean
CCR. Using this method, the national
CCR ceiling is set at 1.57 for FY 2014.
This means that, if an individual IRF’s
CCR exceeds this ceiling of 1.57 for FY
2014, we will replace the IRF’s CCR
with the appropriate national average
CCR (either rural or urban, depending
on the geographic location of the IRF).
We estimate the national CCR ceiling
by:
Step 1. Taking the national average
CCR (weighted by each IRF’s total costs,
as discussed above) of all IRFs for which
we have sufficient cost report data (both
rural and urban IRFs combined).
Step 2. Estimating the standard
deviation of the national average CCR
computed in step 1.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
Step 3. Multiplying the standard
deviation of the national average CCR
computed in step 2 by a factor of 3 to
compute a statistically significant
reliable ceiling.
Step 4. Adding the result from step 3
to the national average CCR of all IRFs
for which we have sufficient cost report
data, from step 1.
We did not receive any comments on
the proposed updates to the IRF CCR
ceilings and urban/rural averages.
Final Decision: We did not receive
any comments on the IRF CCR ceiling
or urban/rural averages. Therefore, we
are finalizing the national average urban
CCR at 0.516, the national average rural
CCR at 0.643, and the national CCR
ceiling at 1.57 percent for FY 2014.
These updates are effective October 1,
2013.
VIII. Refinements to the Presumptive
Compliance Methodology
A. Background on the Compliance
Percentage
The compliance percentage has been
part of the criteria for defining IRFs
since implementation of the IPPS in
1983. In the September 1, 1983 interim
final rule with comment period (48 FR
39752) which allowed IRFs to be paid
separately from the IPPS, the initial
compliance percentage was set at 75
percent. The 1983 interim rule
stipulated that in accordance with
sections 1886(d)(1)(B) and
1886(d)(1)(B)(ii) of the Act, a
rehabilitation hospital and a
rehabilitation unit were excluded from
the IPPS. Sections 1886(d)(1)(B) and
1886(d)(1)(B)(ii) of the Act also give the
Secretary the discretion to define a
rehabilitation hospital and unit.
A hospital or unit deemed excluded
from the IPPS and paid under the IRF
PPS must meet the general requirements
in subpart B and subpart P of part 412.
Subject to the special payment
provisions of § 412.22(c), a hospital or
unit must meet the general criteria set
forth in § 412.22 and in the regulations
at § 412.23(b), § 412.25, and § 412.29
that specify the criteria for a provider to
be classified as a rehabilitation hospital
or unit. Hospitals and units meeting
these criteria are eligible to be paid on
a prospective payment basis as an IRF
under the IRF PPS.
The 1983 interim final rule stipulated
that one of the criteria for being
classified as an IRF was that, during the
facility’s most recently completed 12month cost reporting period, the
hospital must be primarily engaged in
furnishing intensive rehabilitation
services, as demonstrated by patient
medical records, indicating that at least
PO 00000
Frm 00021
Fmt 4701
Sfmt 4700
47879
75 percent of the IRF’s patient
population were treated for one or more
of the 10 medical conditions specified
in the regulation that typically required
the intensive inpatient rehabilitation
treatment provided in an IRF. These
criteria, along with other related criteria,
distinguished an inpatient rehabilitation
hospital or unit from a hospital that
furnished general medical or surgical
services, as well as rehabilitation
services. We believed then, as we do
now, that by examining the types of
conditions for which a hospital’s
inpatients are treated, and the
proportion of patients treated for
conditions that typically require
intensive inpatient rehabilitation, we
would be able to distinguish those
hospitals in which the provision of
rehabilitation services was primary
rather than secondary. Thus, Medicare
pays for rehabilitation services at IRFs at
a higher rate than other hospitals
because IRFs are designed to offer
specialized inpatient rehabilitation care
to patients with intensive needs.
The original medical conditions
specified under the compliance
percentage, or ‘‘75 percent rule,’’ were
stroke, spinal cord injury, congenital
deformity, amputation, major multiple
trauma, fracture of femur (hip fracture),
brain injury, and polyarthritis
(including rheumatoid arthritis). In the
January 3, 1984 final rule (49 FR 234),
we expanded the list of eligible medical
conditions to include neurological
disorders (including multiple sclerosis,
motor neuron diseases, polyneuropathy,
muscular dystrophy, and Parkinson’s
disease) and burns. In the May 7, 2004
final rule (69 FR 25752), we modified
and expanded the list of eligible
medical conditions by removing
polyarthritis and substituting three more
clearly defined arthritis-related
conditions. The three conditions that
replaced polyarthritis included the
following:
• Active, polyarticular rheumatoid
arthritis, psoriatic arthritis, and
seronegative arthropathies resulting in
significant functional impairment of
ambulation and other activities of daily
living, which has not improved after an
appropriate, aggressive, and sustained
course of outpatient therapy services or
services in other less intensive
rehabilitation settings immediately
preceding the inpatient rehabilitation
admission or which results from a
systemic disease activation immediately
before admission, but has the potential
to improve with more intensive
rehabilitation.
• Systemic vasculidities with joint
inflammation, resulting in significant
functional impairment of ambulation
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47880
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
and other activities of daily living,
which has not improved after an
appropriate, aggressive, and sustained
course of outpatient therapy services or
services in other less intensive
rehabilitation settings immediately
preceding the inpatient rehabilitation
admission or which results from a
systemic disease activation immediately
before admission, but has the potential
to improve with more intensive
rehabilitation.
• Severe or advanced osteoarthritis
(osteoarthrosis or degenerative joint
disease) involving three or more major
joints (elbow, shoulders, hips, or knees)
with joint deformity and substantial loss
of range of motion, atrophy, significant
functional impairment of ambulation
and other activities of daily living,
which has not improved after an
appropriate, aggressive, and sustained
course of outpatient therapy services or
services in other less intensive
rehabilitation settings immediately
preceding the inpatient rehabilitation
admission but has the potential to
improve with more intensive
rehabilitation. (A joint replaced by a
prosthesis is no longer considered to
have osteoarthritis, or other arthritis,
even though this condition was the
reason for the joint replacement.)
In the May 7, 2004 final rule (69 FR
25752), a 13th condition was also added
to include patients who undergo knee
and/or hip joint replacement during an
acute hospitalization immediately
preceding the inpatient rehabilitation
stay and also meet at least one of the
following specific criteria:
• Underwent bilateral knee or hip
joint replacement surgery during the
acute hospitalization immediately
preceding the IRF admission.
• Are extremely obese patients as
measured by the patient’s Body Mass
Index (BMI) of at least 50, at the time
of admission to the IRF.
• Are patients considered to be ‘‘frail
elderly,’’ as determined by a patient’s
age of 85 or older, at the time of
admission to the IRF (the provision
currently states only that the patients be
age 85 or older at the time of admission
to the IRF)
In 2002, we surveyed Medicare fiscal
intermediaries to determine how they
were enforcing the 75 percent rule.
Although the 75 percent rule was one of
the criteria that were used to distinguish
an IRF from an acute care hospital from
1983 to 2004, we found evidence that
different fiscal intermediaries were
enforcing the rule differently. We found
fiscal intermediaries were using
inconsistent methods to determine
whether IRFs were in compliance with
the regulation, and that some IRFs were
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
not being reviewed for compliance at
all. This led to concerns that some IRFs
might have been out of compliance with
the regulation and inappropriately
classified as IRFs, while other IRFs may
have been held to overly high standards.
Because of these concerns we sought to
establish a more uniform enforcement of
the 75 percent rule.
In the May 16, 2003 IRF PPS proposed
rule (68 FR 26786), we solicited
comments on the regulatory
requirements of the 75 percent rule.
Though we did not, at that time,
propose amending the regulatory
requirements for the 75 percent rule
located in then § 412.23(b)(2), we did
propose to amend these requirements in
the September 9, 2003 proposed rule
titled, ‘‘Medicare Program; Changes to
the Criteria for Being Classified as an
Inpatient Rehabilitation Facility’’ (68 FR
53266). In that rule, we proposed some
revisions to the 75 percent rule,
including lowering the compliance
percentage to 65 percent during a 3-year
transition period for cost reporting
periods between January 1, 2004 and
January 1, 2007. Also, in response to
comments on the September 9, 2003
proposed rule and as stated above, the
May 7, 2004 final rule (69 FR 25752)
expanded the number of medical
conditions that would meet the
compliance percentage from 10 to 13
and provided that patient comorbidities
may also be included in determining an
IRF’s compliance with the requirements
during the transition period.
In the September 9, 2003 proposed
rule, we defined a ‘‘comorbidity’’ as a
specific patient condition that is
secondary to the patient’s principal
diagnosis or impairment that is the
primary reason for the inpatient
rehabilitation stay. In the May 7, 2004
rule, we adopted the provision to use a
patient with a comorbidity counting
towards the compliance threshold
during the transition period. In the
determination of the compliance
percentage, a patient comorbidity
counts toward the percentage if the
comorbidity falls in one of the
conditions specified at § 412.29(b)(2)
and has caused significant decline in
functional ability in the individual that
even in the absence of the admitting
condition, the individual would require
the intensive rehabilitation treatment
that is unique to IRFs.
Anticipating that IRFs needed some
time to adjust and adapt their processes
to the changes in the enforcement of the
75 percent rule, in the May 7, 2004 final
rule, we provided IRFs with a 3-year
phase-in period (cost reporting periods
beginning on or after July 1, 2004
through July 1, 2007) to establish the
PO 00000
Frm 00022
Fmt 4701
Sfmt 4700
compliance threshold of 75 percent of
the IRF’s total patient population. The
3-year phase-in period was intended to
begin with cost reporting periods on or
after July 1, 2004 with the threshold at
50 percent of the IRF’s population and
gradually increase to 60 percent, then to
65 percent, and then to expire with cost
reporting periods beginning on or after
July 1, 2007, when the compliance
percentage would once again be at 75
percent.
Section 5005 of the Deficit Reduction
Act of 2005 (DRA, Pub. L. 109–171,
enacted February 8, 2006) and section
1886(d)(1)(B) of the Act modified the
provisions of the 75 percent rule
originally specified in the May 7, 2004
final rule. To reflect these statutory
changes, in the August 7, 2007 final rule
(72 FR 44284), we revised the
regulations to prolong the overall
duration of the phased transition to the
full 75 percent threshold by stipulating
that an IRF must meet the full 75
percent compliance threshold as of its
first cost reporting period that starts on
or after July 1, 2008. We also extended
the policy of using a patient’s
comorbidities to the extent they met the
conditions as outlined in the regulations
to determine compliance with the
classification criteria at then
§ 412.23(b)(2)(1) to the first cost
reporting period that starts on or after
July 1, 2008.
Subsequently, section 115 of the
MMSEA amended section 5005 of the
DRA to revise elements of the 75
percent rule that are used to classify
IRFs. In accordance with the statute, in
the August 8, 2008 final rule (73 FR
46370), we revised the compliance rate
that IRFs must meet to be excluded from
the IPPS and be paid under the IRF PPS
to 60 percent for cost reporting periods
beginning in or after July 1, 2006. Also,
in accordance with the statute, we
required that patient comorbidities that
satisfy the criteria as specified at then
§ 412.23(b)(2)(i) [now located at
§ 412.29(b)(1) and § 412.29(b)(2)] be
included in calculations used to
determine whether an IRF meets the 60
percent compliance percentage for cost
reporting periods beginning on or after
July 1, 2007. As a result of these
changes, the requirements started being
referred to as the ‘‘60 percent rule,’’
instead of the ‘‘75 percent rule.’’ The
regulations finalized in the FY 2009 IRF
PPS Final Rule (73 FR 46370) continue
to be in effect.
Though an IRF must serve an
inpatient population of whom at least
60 percent meet the compliance
percentage criteria specified at
§ 412.29(b), the existing regulation
allows for 40 percent of reasonable and
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
necessary admissions to an IRF to fall
outside of the 13 qualifying medical
conditions. Still, the ‘‘60 percent rule’’
is one of the primary ways we
distinguish an IRF from an acute care
hospital. As Medicare payments for IRF
services are generally significantly
higher than Medicare payments for
similar services provided in acute care
hospital settings, we believe that it is
important to maintain and enforce the
criteria for medical conditions that may
be counted toward an IRF’s compliance
calculation for the 60 percent rule to
ensure that the higher Medicare
payments are appropriately allocated to
those providers that are providing IRFlevel services.
B. Changes to the ICD–9–CM Codes That
Are Used To Determine Presumptive
Compliance
The presumptive compliance method
is one of two ways that Medicare’s
contractors may evaluate an IRF’s
compliance with the 60 percent rule
(the other method is called the medical
review method). IRFs may only be
evaluated using the presumptive
compliance method if their Medicare
Fee-for-Service and Medicare Advantage
patient populations make up over half
of their total patient population, so that
the Medicare populations can be
presumed to be representative of the
IRF’s total patient population. If an IRF
is eligible to have its compliance under
the 60 percent rule measured using the
presumptive compliance method, under
the rule, it is given the option of
whether the Medicare contractor will
review all of the IRF’s discharges from
that period, or all admissions from that
period. All of its IRF–PAI assessments
in the chosen category from the most
recently completed 12 month
compliance review period are then
examined (with the use of a computer
program) to determine whether they
contain any of the ICD–9–CM diagnosis
codes that are listed in the ‘‘ICD–9–CM
Codes That Meet Presumptive
Compliance Criteria’’ (which is also
known as the presumptive methodology
list). Each selected assessment is
categorized as either meeting or not
meeting the criteria for the medical
conditions that may be counted towards
the IRF’s 60 percent rule compliance
calculation based on coded information
about the primary reason the patient
was admitted to the IRF (the impairment
group) and the ICD–9–CM codes listed
as either the etiologic diagnosis (the
etiologic problem that led to the
condition for which the patient is
receiving rehabilitation) or one of the
comorbidities listed on the assessment.
An impairment group code is not an
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
ICD–9–CM code, but part of a separate
unique set of codes specifically
developed for the IRF PPS for assigning
the primary reason for admission to an
IRF. Those ICD–9–CM diagnosis codes
that appear on the patient’s IRF–PAI
assessment as either the etiologic
diagnosis or comorbid conditions that
are also listed in ‘‘ICD–9–CM Codes
That Meet Presumptive Compliance
Criteria’’ are deemed to demonstrate
that the patient meets the criteria for the
medical conditions that may be counted
toward the IRF’s compliance percentage
under the presumptive compliance
method of calculating the compliance
percentage. The current presumptive
compliance list can be downloaded
from the October 1, 2007 IRF
Compliance Rule Specification Files on
the Medicare IRF PPS Web site at
https://www.cms.gov/Medicare/Medicare
-Fee-for-Service-Payment/Inpatient
RehabFacPPS/Criteria.html. The ICD–9–
CM Codes That Meet Presumptive
Compliance Criteria that takes what we
are finalizing in this rule into account
can be downloaded from the Medicare
IRF PPS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/InpatientRehab
FacPPS/Data-Files.html. We will build
our ICD–10–CM version of the
presumptive methodology list off of this
document.
The underlying premise of the
presumptive methodology list is that it
represents particular diagnosis codes
that, if applicable to a given patient,
would more than likely mean that the
patient required intensive rehabilitation
services for treatment of one or more of
the conditions specified at § 412.29(b)(2)
or that they had a comorbidity that
caused significant decline in functional
ability such that, even in the absence of
the admitting condition, the patient
would require the intensive
rehabilitation treatment that is unique to
inpatient rehabilitation facilities and
cannot be appropriately performed in
another care setting.
Recently, we began a close
examination of the list of ICD–9–CM
codes that are currently deemed to meet
the criteria for the medical conditions
that may be counted toward an IRF’s
compliance with the 60 percent rule
under the presumptive compliance
method to begin the process of
converting this code list to ICD–10–CM.
Upon this examination, we found that
changes over time (including changes in
the use of the individual codes, changes
in clinical practice, changes in the
frequency of various types of illness and
disability, and changes to the
application of 60 percent rule itself)
supported our updating the ICD–9–CM
PO 00000
Frm 00023
Fmt 4701
Sfmt 4700
47881
codes that are deemed appropriate to
count toward a facility’s 60 percent rule
compliance calculation. Such updates
would ensure that the codes better
reflect the regulations at § 412.29(b).
Our review included taking a fresh
look at the regulations in § 412.29(b),
which revealed that the following parts
of the regulation were not being
adequately addressed in the current
application of the presumptive method
of calculating compliance with the IRF
60 percent rule:
• The details of the requirements in
paragraph § 412.29(b)(1), which specify
that the IRF must serve ‘‘an inpatient
population of whom at least 60 percent
required intensive rehabilitation
services for treatment of one or more of
the conditions specified . . .’’, and
• The details of the requirements
regarding the specific conditions under
which a patient’s comorbidity may be
used to show that a patient meets the 60
percent rule criteria, specifically that,
‘‘The comorbidity has caused significant
decline in functional ability in the
individual that, even in the absence of
the admitting condition, the individual
would require the intensive
rehabilitation treatment that is unique to
inpatient rehabilitation
facilities . . .and that cannot be
appropriately performed in another care
setting . . .’’
These requirements must be met in
conjunction with a patient having one of
the 13 conditions listed in § 412.29(b)(2)
for the case to meet the 60 percent rule
compliance criteria. It is not enough for
the patient to just have one of the 13
conditions. Mindful of these
requirements, we took a fresh look at the
ICD–9–CM codes on the presumptive
methodology list.
Further, the regulations in § 412.29
also specify that the arthritis conditions
only meet the 60 percent rule
compliance criteria if certain severity
and prior treatment criteria are met. It
is impossible to discern from the ICD–
9–CM codes alone whether or not the
required severity and prior treatment
criteria are met for those patients being
treated for arthritis conditions. This
type of information can only be assessed
on medical review. Thus, we found that
the presence of the ICD–9–CM code, by
itself, cannot always allow us to
presume that patients meet all of the
requirements for being counted toward
a facility’s meeting the 60 percent rule
requirements. As such, we believe that
certain ICD–9–CM codes currently on
the presumptive methodology list do
not necessarily demonstrate a patient’s
meeting the medical condition
(including severity and prior treatment)
requirements for inclusion in a facility’s
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47882
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
60 percent compliance calculation
under the presumptive compliance
method, and, as such, should be
removed from the presumptive
methodology list to better reflect the
regulations.
Therefore, we performed a clinical
analysis of the ICD–9–CM code list to
determine the clinical appropriateness
of each individual ICD–9–CM code’s
inclusion on the list, and a statistical
analysis of the ICD–9–CM diagnoses
code list to enhance our understanding
of how individual ICD–9–CM codes are
being used by IRFs. Based on these
analyses, we proposed specific revisions
to the ICD–9–CM code list that are
described below in sections VIII.B.1
through VIII.B.6 of this final rule.
We received 39 public comments on
the proposed changes to the
presumptive methodology list, which
are summarized below.
Comment: Several commenters stated
that section 5005 of the DRA of 2005,
and section 115 of the MMSEA of 2007
‘‘codified’’ the 13 qualifying medical
conditions that were originally adopted
in our May 7, 2004 final rule and that
were still in the regulations in effect as
of January 1, 2007, and froze the
compliance threshold at 60 percent.
These commenters also expressed the
belief that CMS does not have the legal
authority to make changes to the
presumptive methodology list as
proposed and must appeal to Congress
to make such changes. One commenter
stated that Congress ‘‘was clear in the
statute’’ that for purposes of
determining a facility’s compliance
under the presumptive compliance
method, that CMS should utilize the
May 7, 2004 final rule and the 13
qualifying medical conditions described
in that final rule.
Response: While the commenters are
correct that the DRA of 2005 and the
MMSEA of 2007 both referenced the
regulatory text that was adopted in the
May 7, 2004 final rule, or the rule itself,
we disagree with the assertion that the
proposed changes to the ‘‘ICD–9–CM
Codes That Meet Presumptive
Compliance Criteria’’ list are in
contravention of section 5005 of the
DRA as amended by section 115 of
MMSEA. Additionally, as we did not
propose any changes to the compliance
threshold (it remains at 60 percent), the
comments regarding the 60 percent
threshold are outside the scope of this
rule.
Subsection (a) of section 5005 of the
DRA stipulated that the Secretary
should apply the applicable percent ‘‘in
the classification criterion used under
the IRF regulation (as defined in
subsection (c)) to determine whether a
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
hospital or unit of a hospital is an
inpatient rehabilitation facility under
the Medicare program under title XVIII
of the Social Security Act.’’ Subsection
(c) of section 5005 of the DRA then
stated that ‘‘[f]or purposes of subsection
(a), the term ‘‘IRF regulation’’ means the
rule published in the Federal Register
on May 7, 2004. . . .’’
Even if we were to agree with
commenters’ assertions that this crossreference froze the medical conditions
that could be considered for the 75percent compliance rule to the 13
medical conditions listed in the May 7,
2004 final rule, however, it would not
follow that Congress froze the subregulatory means of verifying
compliance with the severity and prior
treatment requirements that were
contained in that final rule. We disagree
with any assertion that the proposed
removal of certain ICD–9–CM codes
from the sub-regulatory listing of codes
that presumptively count toward the
IRF compliance calculation under the
presumptive compliance method would,
in fact or effect, remove any of the 13
qualifying medical conditions under the
classification criteria established in our
May 7, 2004 final rule (69 FR 25752).
Rather, it merely means that the medical
review method would need to be used.
For example, the ‘‘arthritis’’ categories
in the May 7, 2004 final rule only
included those arthritis patients that
meet the severity and pretreatment
conditions specified in the regulations
prior to the patient’s admission to the
IRF. See, the former 42 CFR
§ 412.23(b)(2)(iii)(L), which can be
found at 69 FR 25772. As such, the
severity and pretreatment requirements
were part of the defined condition, and
any sub-regulatory procedures to
implement these regulatory conditions
would have to take into account the
need to ensure compliance with these
severity and pretreatment requirements.
Furthermore, while the May 7, 2004
final rule noted that CMS would be
issuing sub-regulatory guidance to its
contractors that were to be tasked with
the administration of the verification
process for these requirements, the
substance of such processes is not in the
final rule. What are in the rule,
however, are multiple statements that
ICD–9–CM diagnosis codes alone would
not, in the absence of additional clinical
data, demonstrate compliance with the
severity and pre-treatment
requirements. Some other mechanism,
such as medical review, was
contemplated from the outset for these
conditions (69 FR 25752, 25755 and
25761).
Thus, we have not proposed changes
to the criteria established in the May 7,
PO 00000
Frm 00024
Fmt 4701
Sfmt 4700
2004 final rule. It remains as a list of 13
medical conditions, at times, paired
with additional severity and prior
treatment requirements. And, with the
exception of discussion about imputing
the Medicare portion of a facility’s
patient population compliance
percentage to the entire population
when the Medicare population
represents the majority of that facility’s
patients, it did not discuss, let alone
‘‘codify’’ the methods we would use to
verify IRFs’ compliance percentages.
Rather, we merely stated in that rule
that we would issue instructions to the
FIs that serve as the Medicare
contractors and provide guidance to the
clinical/medical FI personnel
responsible for performing the
compliance reviews to ensure that they
use a method that consistently counts
only cases with a diagnosis that both
serves as the basis for intensive
rehabilitation services and meets one of
the 13 qualifying medical conditions;
noted that we were still determining
how best to provide guidance to the FIs
on how to identify patients that fall into
the 13 medical conditions; noted that
we would not be providing ICD–9–CM
codes in response to a commenter
because diagnosis would be only one
aspect of the FI’s determination; and
stated that FIs would also ‘‘review
information to assess (1) the medical
necessity of rehabilitation in an
inpatient setting; (2) the severity of the
specific condition(s); (3) the patient’s
function; and (4) the capacity of the
patient to participate in intensive
rehabilitation and benefit from it.’’
As such, we believe that the proposed
removal of some of the ICD–9–CM codes
in our sub-regulatory presumptive
methodology list is consistent with the
legislation and the May 7, 2004
regulation. We have not proposed the
revision of the list of 13 medical
conditions or the severity and prior
treatment requirements that were paired
with those conditions. For example,
consistent with the severity and
pretreatment requirements defined in
the regulations (which are currently
located at § 412.29(b)(2)(x) through
§ 412.29(b)(2)(xiii), we proposed the
removal of the ‘‘arthritis’’ ICD–9–CM
codes because those codes do not
provide the pertinent information
necessary to assess whether the
applicable severity and prior treatment
requirements for those conditions have
been met. If and when the severity and
pretreatment requirements are
confirmed using the medical review
method, however, patients with those
arthritis conditions will be counted
toward the IRF’s compliance threshold.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
In this manner, we administratively
apply the regulation as codified and as
outlined in the May 7, 2004 final rule.
Ultimately, the code refinements to the
ICD–9–CM Codes That Meet
Presumptive Compliance Criteria list
will ensure that the codes represent the
types of medical conditions that we
believe clearly, and without further
evidence, can be found to indicate that
the criteria for the medical conditions
that may be counted toward the 60
percent rule compliance calculation
have been met, and, therefore, that the
presumptive compliance method can be
used to include that individual in the
IRF’s compliance percentage.
Comment: Several commenters
suggested that we delay these
refinements to the presumptive
compliance list until next year when the
implementation of ICD–10–CM is
planned. Commenters also stated that
making these changes effective for
discharges on or after October 1, 2013
will cause significant disruption for
providers. One commenter asked for
clarification regarding how the
proposed changes would be
implemented, specifically whether the
prior list would be applied for the first
part of a facility’s fiscal year and the
new list be applied for the second part.
Several commenters asked that we
provide a 6-month transition period to
implement these changes.
Response: We considered the impact
that our proposals would have on IRF
providers if we were to make the
changes effective for FY 2014 instead of
in FY 2015 when we plan to move to
ICD–10–CM. We believed that a gradual
approach allowing IRF providers time to
adjust their coding practices in response
to the specific changes made to the
presumptive methodology list before
also moving to ICD–10–CM was the
appropriate course of action. However,
we recognize that IRFs may need more
time to adjust to the changes to the
presumptive methodology list. In
recognition of these concerns, we will
adopt these changes, but only apply the
revised list to compliance review
periods beginning on or after October 1,
2014. This will eliminate any problems
associated with changing lists in the
middle of a fiscal year.
Comment: One commenter supported
our efforts to refine the list of ICD–9–
CM codes in the presumptive
methodology list. But, the commenter
also stated that a better overall system
would be one in which payment
systems would be focused on patientbased criteria at the level of the episode
of care or other broader site-neutral
systems; however, within the current
payment system, they supported CMS’
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
efforts to improve accuracy in
determining the need for the intensive
inpatient rehabilitation services that
IRFs provide. Further, the commenter
stated that by ‘‘requiring IRFs to use
more detailed coding, we could
potentially collect information on IRF
patients that would differentiate them
from patients with similar conditions
who are treated in other settings (for
example, skilled nursing facilities, home
health agencies, or outpatient therapy
providers).’’
Response: We thank the commenter
for their support of our efforts to refine
the presumptive methodology list so
that it reflects codes that truly indicate
compliance with the 60 percent rule
criteria for inclusion in the compliance
calculation. Additionally, we thank the
commenter for their suggestions as the
agency continues research efforts into
broader site-neutral payment systems.
Comment: Several commenters stated
that they had concerns about the
viability of the ‘‘60 percent rule.’’ One
commenter stated that the 60 percent
rule should be repealed or modified in
that the current classification criteria do
not reflect the full range of factors that
contribute to a patient’s need for
intensive inpatient rehabilitation. The
commenter also stated that if we
continue to use the 60 percent rule, then
the list of 13 qualifying medical
conditions under the 60 percent rule
should be expanded to include patients
with the following conditions:
orthopedic/joint/limb replacement
patients, post-transplant patients,
patients with chronic pulmonary and
cardiac conditions, and medically
complex patients.
Response: We appreciate the
commenters’ suggestions, and will take
these suggestions into account in future
analyses. However, since we did not
propose any modifications to the
qualifying medical conditions for the 60
percent rule, these comments are
beyond the scope of this final rule.
Comment: One commenter stated that
we should clarify the alphabet
designations for appendices associated
with IRF–PAI completion because in
our rules (this year and in past
rulemakings) we have used the same
alphabet character for more than one
list.
Response: We agree that the alphabet
designations used for appendices in the
IRF PPS may lead to confusion because
appendices for several tables are listed
with the same alphabet character.
Appendix C: ICD–9–CM Codes That
Meet Presumptive Compliance Criteria
is used to determine an IRF’s
presumptive compliance with the 60
percent rule. However, there is also the
PO 00000
Frm 00025
Fmt 4701
Sfmt 4700
47883
list of comorbidities (ICD–9–CM codes)
that is used to determine placement in
tiers, Appendix C—List of
Comorbidities. Beginning with the
publication of this rule, we will no
longer use alphabet characters to
identify these appendices. Beginning
with this final rule and related subregulatory guidance, we will refer to the
two lists by their titles, without the
Appendix labels.
Comment: One commenter
recommended that in lieu of removing
the ICD–9–CM codes from the ICD–9–
CM Codes That Meet Presumptive
Compliance Criteria, CMS should
establish modifiers that could be
entered on the IRF–PAI to indicate that
the patient meets the requirements for
the medical conditions that may be
included in the IRF’s presumptive
compliance method’s compliance
calculation. The commenter offered the
following example that is used on
claims: the KX modifier with respect to
outpatient therapy services to indicate
that a patient qualifies for an exception
to the therapy caps on the claim. The
commenter stated that using modifiers
would ensure that ‘‘clinically
appropriate’’ records would count under
the presumptive compliance method
compliance calculations without having
to do medical review.
Response: We appreciate the
commenter’s suggestion. However, we
note that the presumptive compliance
method relies on information recorded
on the IRF–PAI, rather than information
from the IRF claim. The purpose of the
IRF–PAI is to collect the clinical
characteristics of the patient for use in
care planning, payment, and quality
reporting and therefore we believe it
presents a more accurate and
comprehensive record of the medical
conditions of the patient, which is
important when the record is then used
to calculate the presumptive compliance
percentage. Thus, we do not currently
use and are not planning in the future
to use, the IRF claim for the
presumptive compliance method. Thus,
a modifier applied to the coding on the
claim, similar to the KX modifier for
outpatient therapy services, is not useful
in this context, and we do not currently
have a similar mechanism for modifying
codes on the IRF–PAI. However, we will
take the commenter’s suggestions into
consideration. We believe that a delayed
implementation of the changes to the
presumptive compliance list of ICD–9–
CM codes will allow us additional time
to study ways to minimize the burden
of the operational aspects of the changes
to the presumptive compliance
methodology.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47884
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
Comment: Several commenters stated
that we have incorrectly applied a
medical necessity measurement (the
coverage criteria) to the 60 percent rule.
One commenter stated that we conflated
individualized medical necessity review
with the presumptive compliance
method’s review. Another commenter
requested that we distinguish between
the policies for IRF classification criteria
and medical necessity coverage criteria
in the final rule.
Response: We disagree with the
commenters; we are not conflating the
criteria for the medical conditions that
may be counted under the presumptive
method to determine compliance with
the 60 percent rule with the coverage
criteria. IRF coverage criteria are not
used to determine IRF classification. As
we stated in the August 7, 2009 final
rule (74 FR 39762), we do not intend for
any IRF to lose its classification status
because an individual patient does not
meet the coverage criteria. Failure to
meet the coverage criteria in a particular
case will only result in the denial of the
IRF’s claim for the services provided to
that patient, not in a change in the
classification of the facility.
Comment: Several commenters
expressed concerns that, in the
proposed rule, we changed our policy
articulated in previous rules of
distinguishing IRFs from other care
settings by identifying certain
conditions that ‘‘typically require’’
intensive inpatient rehabilitation.
Specifically, commenters asserted that
we have deviated from the policy
standard of serving those with
conditions that ‘‘typically required’’ an
IRF-level of service. The commenters
point to our statement in the proposed
rule that ‘‘[i]t is not enough for the
patient to just have one of the 13
conditions’’ to indicate that we
proposed adding additional criteria to
the medical conditions that may be
counted under the presumptive
compliance method. For example, the
commenters believed that we had
proposed adding a new criterion by
indicating that beyond having one of the
13 medical conditions, we now
proposed to require that patients need
intensive inpatient rehabilitation
services. According to the commenters,
this is inconsistent with the history of
the 60 percent rule and our own
interpretations of the policy in previous
rulemaking.
Response: We disagree with the
commenters’ assertions that we have
introduced new criteria to the
presumptive compliance method of
determining whether an IRF has met the
criteria for a given medical condition
such that the individual with that
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
condition may be counted toward the
IRF’s 60 percent rule compliance
percentage. Section 412.29 outlines the
requirements for a facility to be
classified for payment under the IRF
PPS. Within this section, the regulations
at § 412.29(b)(1) require the IRF to
demonstrate that it ‘‘served an inpatient
population of whom at least 60 percent
required intensive rehabilitation
services for treatment of one or more of
the conditions specified at paragraph
(b)(2) . . . (emphasis added). As such,
the ‘‘intensive rehabilitation service
needs’’ criterion is part of the original
criteria for the medical conditions that
can be counted toward an IRF’s 60
percent rule compliance rate. We also
point out that this particular part of the
regulation read the same in the May 7,
2004 final rule (then codified in
§ 412.23(b)(2)(i), now codified in
§ 412.29(b)(1)). Thus, our statement in
the proposed rule was consistent with
what has been our stated policy since
the May 7, 2004 final rule.
We also disagree with any assertion
that the proposed changes to the
presumptive methodology list are an
indication that we have departed from
historical discussions outlined in the
preamble of previous rules. As we stated
previously, we are not revising the
criteria that govern the 13 medical
conditions that may be counted toward
an IRF’s 60 percent rule compliance
percentage. In the preamble of the May
7, 2004 final rule, when discussing how
CMS contractors would administratively
identify patients with the 13 medical
conditions, we specifically declined to
provide a list of ICD–9–CM codes
because ICD–9–CM codes alone are not
always enough to ascertain whether
someone falls into one of the 13 medical
condition categories. As such, the
regulations have never included such a
list. Rather, we use a bifurcated subregulatory approach with a presumptive
compliance method and a medical
review compliance method. We
continue to believe that the 13 medical
conditions that are listed in regulation
at § 412.29(b)(2) are conditions that
‘‘typically’’ require the level of intensive
rehabilitation that provide the basis of
need to differentiate the services offered
in IRFs from those offered in other care
settings.
Comment: One commenter requested
that we make available the methodology
that was used to assess the ‘‘clinical
appropriateness’’ determinations for the
ICD–9–CM codes that were proposed for
removal.
Response: To analyze the ‘‘clinical
appropriateness’’ of the ICD–9–CM
codes on the list used to determine
compliance under the presumptive
PO 00000
Frm 00026
Fmt 4701
Sfmt 4700
compliance method, we used the
extensive clinical and coding expertise
available within CMS’s staff. Our
clinical staff went through the current
list code-by-code to determine whether,
in their professional judgment, a
particular ICD–9–CM code’s use would
indicate a patient’s presumptive need
for intensive inpatient rehabilitation for
one of the 13 medical conditions listed
in 412.29(b)(2), absent additional
information about a particular patient’s
clinical condition and rehabilitation
needs. The details of our clinical
rationale for each of the proposed
changes to the ICD–9–CM codes used to
determine compliance percentages
under the presumptive compliance
method were presented in the FY 2014
IRF PPS proposed rule (78 FR 26880 at
26895 through 26906) and are further
reflected in this final rule. We also used
the public comments we received on the
FY 2014 IRF PPS proposed rule (78 FR
26880) to further refine our clinical
analysis, in that we used a lot of the
input from commenters in forming our
final decisions regarding which ICD–9–
CM codes to retain on the list and which
to proceed to remove from the list. As
discussed in detail below, in some cases
we agreed with the commenter’s input
and have added codes back to the list,
as appropriate.
Comment: Several commenters
requested that we make an IRF’s
presumptive testing data available to
that IRF to allow the IRF to monitor its
presumptive compliance with the 60
percent rule.
Response: Until now, we did not have
the capability within our data system for
securely communicating information
about an IRF’s individual IRF–PAI
submissions back to that IRF. We are in
the process of developing such a system,
and will consider the feasibility of
incorporating a report of an IRF’s
compliance percentage into this new
system.
1. Non-Specific Diagnosis Codes
We believe that highly descriptive
coding provides the best and clearest
way to document the appropriateness of
a given patient’s admission, and would
improve our ability to use the
presumptive compliance method of
calculating a facility’s 60 percent rule
compliance percentage. Therefore,
whenever possible, we believe that the
most specific code that describes a
medical disease, condition, or injury
should be used to document diagnoses
on the IRF–PAI. Generally,
‘‘unspecified’’ codes are used when
there is a lack of information about
location or severity of medical
conditions in the medical record.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
However, site and/or severity of
condition is often an important
determinant in assessing whether a
patient’s principal or secondary
diagnosis falls into the 13 qualifying
medical conditions that may be counted
toward the facility’s 60 percent rule
compliance percentage under the
presumptive compliance method. For
this reason, we believe that specific
diagnosis codes that narrowly identify
anatomical sites where disease, injury,
or condition exist should be used when
coding patients’ conditions on the IRF–
PAI whenever such codes are available.
Furthermore, on the same note, we
believe that one should also include on
the IRF–PAI the more descriptive ICD–
9–CM code that indicates the degree of
injury in instances of burns. In
accordance with these principles, we
proposed to remove non-specific codes
from the list, ICD–9–CM Codes That
Meet Presumptive Compliance Criteria,
in instances in which more specific
codes are available as we believe
imprecise codes would inappropriately
categorize an overly broad segment of
the patient population as having the
conditions required for inclusion in a
facility’s presumptive compliance
calculation, which would result in an
inflated compliance percentage. If the
IRF does not have enough information
about the patient’s condition to code the
more specific codes on the IRF–PAI, we
would expect the IRF to seek out
additional information from the
patient’s acute care hospital medical
record to determine the appropriate,
more specific code to use. The list of
ICD–9–CM codes that we proposed
removing can be found in the May 8,
2013 proposed rule at 78 FR 26880,
26901 through 26906.
We received 18 comments on the
proposed changes to the non-specific
diagnosis codes listed in ICD–9–CM
Codes That Meet Presumptive
Compliance Criteria, which are
summarized below.
Comment: Several commenters noted
that IRFs are post-acute settings and that
etiological documentation is based on
the data received from the acute care
hospital. They argued that, in some
cases, the specificity demanded in
coding as described in the proposed rule
cannot be achieved because the
information is not in the records that
IRFs receive from the acute care setting.
For example, for ICD–9–CM codes
433.91—Occlusion and stenosis of
unspecified pre-cerebral artery with
cerebral infarction—and 434.91—
Cerebral artery occlusion, unspecified
with cerebral infarction—, several
commenters stated that a large
proportion of ischemic strokes may not
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
be able to be identified as thrombotic or
embolic. Several commenters stated that
the ICD–9–CM code 434.91—Cerebral
artery occlusion, unspecified with
cerebral infarction—should not be
removed from the presumptive
methodology list because in order to be
more specific the physiatrist would
need to note whether the stroke was
embolic or thrombotic in nature. The
commenters stated that this is often
unknown, even after radiological
results.
Response: We recognize that the IRF
builds its understanding of its patients
that are admitted to the IRF from the
acute care hospital in part from the
acute care medical records, and that
sometimes the information needed to
code a more specific diagnosis is not
available in those records. In the case of
certain ICD–9–CM codes that we had
proposed to remove from the
presumptive compliance list, we agree
with the commenters and have
determined that the information
necessary to appropriately code certain
conditions may not always be available.
To avoid diagnostic misclassification,
we are revising our proposals in Table
7 of the proposed rule and will retain
codes 433.91 and 434.91 on the list of
codes that meet the presumptive
compliance criteria. We may revisit this
decision in the future, if information to
code the more specific diagnosis codes
becomes more readily available.
Though we agree with commenters
that some information is either not
available or may not always be found in
the documentation sent by the acute
care hospital and that this impacts the
coding of some diagnoses, we do not
agree that this is the case for all the
diagnosis codes proposed for removal in
Table 7 of the proposed rule or that the
IRF would not be able to obtain the
necessary information through other
means in many instances. IRFs are
required under the IRF coverage
requirements to conduct thorough
preadmission screenings on all
prospective IRF patients prior to each
IRF admission. During the preadmission
screenings, a complete medical chart
review is required, unless the patient is
being assessed in person by the IRF
personnel conducting the preadmission
screening. Even if the patient is being
assessed in person, a medical chart
review is typically needed to gather all
of the pertinent information to complete
a thorough preadmission screening.
Generally, diagnostic reports,
radiological reports, and consultation
notes, among other informational
documentation are available in the acute
care medical record to assist IRF staff in
building a more complete clinical
PO 00000
Frm 00027
Fmt 4701
Sfmt 4700
47885
picture so that diagnostic coding,
whenever possible, can be more
specific. Even if such information is not
available in the acute care medical
record, however, we believe that the IRF
should make every effort to obtain the
necessary information to code more
specifically.
Comment: We received several
comments on various non-specific
diagnosis codes that the commenters
stated should not be removed from the
list. The commenters provided a variety
of rationales for the continued use of
these codes to meet the presumptive
compliance criteria. For example,
several commenters stated that the ICD–
9–CM codes related to hip fracture
should not be excluded from the list.
The commenters stated that the specific
information required to provide where
the fracture occurred on the neck of the
femur is often not available to IRF staff
that do not have access to x-ray reports
and that such specificity would not
impact the type of treatment in the IRF.
Several other commenters stated that we
should reconsider the proposed removal
of some non-specific traumatic brain
injury codes. The commenters stated
that the removal of these codes is
‘‘administratively unrealistic.’’ The
commenters also stated that for
incidents of loss of consciousness of
short duration this information, usually
documented by on-site emergency
technicians (when known), is no longer
in the records by the time the patient is
admitted to the IRF. One commenter
argued that in cases of unobserved
traumatic brain injury the duration of a
patient’s loss of consciousness may
never be specifically determined. This
commenter further stated that despite
the absence of this information, the
patient may still be clinically
appropriate for intensive inpatient
rehabilitation services.
Several commenters also argued that
the identity of virus or bacteria
associated with diagnoses such as ICD–
9–CM codes 049.9—Unspecified nonarthropod-borne viral diseases of central
nervous system—, 320.9—Meningitis
due to unspecified bacterium—, 322.9—
Meningitis, unspecified—, 323.9—
Unspecified causes of encephalitis,
myelitis, and encephalomyelitis cannot
frequently be found in the medical
records from the transferring hospital or
in some cases may never be known. As
such, the commenters suggest that these
codes not be removed from the
presumptive methodology list.
Several commenters stated that ICD–
9–CM codes 343.9—Infantile cerebral
palsy, unspecified should not be
removed from the presumptive
methodology list because many times
E:\FR\FM\06AUR2.SGM
06AUR2
47886
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
these patients are seen in IRFs as adults,
when the patient’s current clinical
presentation may be different from their
original presentation as infants.
Moreover, the commenters argue, the
adults may have no available medical
records that state the appropriate
cerebral palsy type. Similarly, these
commenters argue that ICD–9–CM code
344.00—Quadriplegia, unspecified
should not be removed from the
presumptive methodology list because
of the potential for a change from the
original presentation that was the basis
of appropriate classification of the level
of completeness of the injury.
Response: Upon further review and
after thoughtful consideration of the
comments we received, we have
determined that several codes that we
proposed to remove from the ICD–9–CM
Codes That Meet Presumptive
Compliance Criteria list should be
retained. Thus, in this final rule we will
not remove these codes from the
presumptive methodology list. The ICD–
9–CM codes that we proposed for
removal from the ICD–9–CM Codes That
Meet Presumptive Compliance Criteria
list, but we have determined should be
retained, are listed in Table 8. We also
note here that we inadvertently
included 4 codes in Table 7 of the
proposed rule that were never on the
ICD–9–CM Codes That Meet
Presumptive Compliance Criteria list.
The codes are as follows: 804.00—
Closed fractures involving skull or face
with other bones, without mention of
intracranial injury, unspecified state of
consciousness—, 804.09—Closed
fractures involving skull of face with
other bones, without mention of
intracranial injury, with concussion,
unspecified—, 851.90—Other and
unspecified cerebral laceration and
contusion, with open intracranial
wound, unspecified state of
consciousness—, 851.99—Other and
unspecified cerebral laceration and
contusion, with open intracranial
wound, with concussion, unspecified.
Comment: Several commenters
expressed concerns about our proposal
to remove ICD–9–CM code 356.9—
Unspecified hereditary and idiopathic
peripheral neuropathy (IPN) from the
ICD–9–CM Codes That Meet
Presumptive Compliance Criteria list
because ‘‘IPN is one of the most
common chronic neurologic disorders
in America.’’ One commenter further
stated that the precise etiology of a
neuropathy has little effect on a
patient’s rehabilitation, and that there
are a limited number of codes that can
be used to specify the type of
neuropathy.
Response: We believe that the fact
that ICD–9–CM code 356.9—
Unspecified hereditary and idiopathic
peripheral neuropathy (IPN)—is such a
commonly used code for multiple types
of chronic neurological disorders in the
U.S. means that it is too broad a
diagnosis to enable us to determine
whether a patient coded with this code
meets the criteria for the medical
conditions that may be counted toward
an IRF’s 60 percent rule compliance
percentage or not. We believe that some
patients coded with this code could
meet the requirements in 412.29(b)(1),
but others would not. That is, we
believe that it is impossible to tell from
the possible application of this code to
such a broad and diverse population of
patients whether patients coded with
this diagnosis code require intensive
rehabilitation services for treatment of
one or more of the conditions specified
at 42 CFR 412.29(b)(2). Our analysis
shows that the percent of patients in
IRFs that are coded with this diagnosis
code has increased substantially over
time (from 2.7 percent of all IRF patients
in FY 2004 to 4.5 percent in FY 2012),
with more dramatic increases occurring
within specific IRF providers. This
finding may be the result of an increase
in the patient population for which this
code applies, an increase in the percent
of patients with these conditions being
admitted to the IRF, or upcoding on the
part of IRFs. Regardless, we believe that
this code does not provide enough
information for us to determine whether
a patient coded with this diagnosis code
would meet the requirements at 42 CFR
412.29(b). Thus, we believe that the
most appropriate course of action at this
time is to remove this code from the
presumptive methodology list.
However, we note that patients that are
coded with this diagnosis code may,
where appropriate upon medical
review, be found to meet the criteria for
the medical conditions that may be
counted toward a facility’s 60 percent
rule compliance percentage.
TABLE 8—ICD–9–CM CODES RETAINED IN ‘‘ICD–9–CM CODES THAT MEET PRESUMPTIVE COMPLIANCE CRITERIA’’ **
tkelley on DSK3SPTVN1PROD with RULES2
ICD–9–CM
Code
Diagnosis
049.9 .................
320.9 .................
322.9 .................
323.9 .................
343.9 .................
344.00 ...............
433.91 ...............
434.91 ...............
800.00 ...............
800.10 ...............
800.20 ...............
800.30 ...............
800.40 ...............
800.50 ...............
800.60 ...............
800.70 ...............
800.80 ...............
800.90 ...............
801.00 ...............
801.10 ...............
801.20 ...............
801.30 ...............
801.40 ...............
801.50 ...............
801.60 ...............
Unspecified non-arthropod-borne viral diseases of central nervous system.
Meningitis due to unspecified bacterium.
Meningitis, unspecified.
Unspecified causes of encephalitis, myelitis, and encephalomyelitis.
Infantile cerebral palsy, unspecified.
Quadriplegia, unspecified.
Occlusion and stenosis of unspecified precerebral artery with cerebral infarction.
Cerebral artery occlusion, unspecified with cerebral infarction.
Closed fracture of vault of skull without mention of intracranial injury, unspecified state of consciousness.
Closed fracture of vault of skull with cerebral laceration and contusion, unspecified state of consciousness.
Closed fracture of vault of skull with subarachnoid, subdural, and extradural hemorrhage, unspecified state of consciousness.
Closed fracture of vault of skull with other and unspecified intracranial hemorrhage, unspecified state of consciousness.
Closed fracture of vault of skull with intracranial injury of other and unspecified nature, unspecified state of consciousness.
Open fracture of vault of skull without mention of intracranial injury, unspecified state of consciousness.
Open fracture of vault of skull with cerebral laceration and contusion, unspecified state of consciousness.
Open fracture of vault of skull with subarachnoid, subdural, and extradural hemorrhage, unspecified state of consciousness.
Open fracture of vault of skull with other and unspecified intracranial hemorrhage, unspecified state of consciousness.
Open fracture of vault of skull with intracranial injury of other and unspecified nature, unspecified state of consciousness.
Closed fracture of base of skull without mention of intra cranial injury, unspecified state of consciousness.
Closed fracture of base of skull with cerebral laceration and contusion, unspecified state of consciousness.
Closed fracture of base of skull with subarachnoid, subdural, and extradural hemorrhage, unspecified state of consciousness.
Closed fracture of base of skull with other and unspecified intracranial hemorrhage, unspecified state of consciousness.
Closed fracture of base of skull with intracranial injury of other and unspecified nature, unspecified state of consciousness.
Open fracture of base of skull without mention of intracranial injury, unspecified state of consciousness.
Open fracture of base of skull with cerebral laceration and contusion, unspecified state of consciousness.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
PO 00000
Frm 00028
Fmt 4701
Sfmt 4700
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
47887
TABLE 8—ICD–9–CM CODES RETAINED IN ‘‘ICD–9–CM CODES THAT MEET PRESUMPTIVE COMPLIANCE CRITERIA’’ **—
Continued
ICD–9–CM
Code
801.70
801.80
801.90
803.00
803.10
803.20
803.30
803.40
803.50
803.60
803.70
803.80
803.90
804.10
Diagnosis
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
804.20 ...............
804.30 ...............
804.40 ...............
804.60 ...............
804.70 ...............
804.80 ...............
804.90 ...............
820.00
820.10
820.30
851.00
851.10
851.20
851.30
851.40
851.50
851.60
851.70
851.80
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
852.00
852.10
852.20
852.30
852.40
852.50
853.00
...............
...............
...............
...............
...............
...............
...............
853.10 ...............
854.00 ...............
854.10 ...............
Open fracture of base of skull with subarachnoid, subdural, and extradural hemorrhage, unspecified state of consciousness.
Open fracture of base of skull with other and unspecified intracranial hemorrhage, unspecified state of consciousness.
Open fracture of base of skull with intracranial injury of other and unspecified nature, unspecified state of consciousness.
Other closed skull fracture without mention of intracranial injury, unspecified state of consciousness.
Other closed skull fracture with cerebral laceration and contusion, unspecified state of consciousness.
Other closed skull fracture with subarachnoid, subdural, and extradural hemorrhage, unspecified state of consciousness.
Other closed skull fracture with other and unspecified intracranial hemorrhage, unspecified state of unconsciousness.
Other closed skull fracture with intracranial injury of other and unspecified nature, unspecified state of consciousness.
Other open skull fracture without mention of injury, unspecified state of consciousness.
Other open skull fracture with cerebral laceration and contusion, unspecified state of consciousness.
Other open skull fracture with subarachnoid, subdural, and extradural hemorrhage, unspecified state of consciousness.
Other open skull fracture with other and unspecified intracranial hemorrhage, unspecified state of consciousness.
Other open skull fracture with intracranial injury of other and unspecified nature, unspecified state of consciousness.
Closed fractures involving skull or face with other bones, with cerebral laceration and contusion, unspecified state of consciousness.
Closed fractures involving skull or face with other bones with subarachnoid, subdural, and extradural hemorrhage, unspecified
state of consciousness.
Closed fractures involving skull or face with other bones, with other and unspecified intracranial hemorrhage, unspecified
state of consciousness.
Closed fractures involving skull or face with other bones, with intracranial injury of other and unspecified nature, unspecified
state of consciousness.
Open fractures involving skull or face with other bones, with cerebral laceration and contusion, unspecified state of consciousness.
Open fractures involving skull or face with other bones with subarachnoid, subdural, and extradural hemorrhage, unspecified
state of consciousness.
Open fractures involving skull or face with other bones, with other and unspecified intracranial hemorrhage, unspecified state
of consciousness.
Open fractures involving skull or face with other bones, with intracranial injury of other and unspecified nature, unspecified
state of consciousness.
Closed fracture of intracapsular section of neck of femur, unspecified.
Open fracture of intracapsular section of neck of femur, unspecified.
Open fracture of trochanteric section of neck of femur, unspecified.
Cortex (cerebral) contusion without mention of open intracranial wound, unspecified state of consciousness.
Cortex (cerebral) contusion with open intracranial wound, unspecified state of consciousness.
Cortex (cerebral) laceration without mention of open intracranial wound, unspecified state of consciousness.
Cortex (cerebral) laceration with open intracranial wound, unspecified state of consciousness.
Cerebellar or brain stem contusion without mention of open intracranial wound, unspecified state of consciousness.
Cerebellar or brain stem contusion with open intracranial wound, unspecified state of consciousness.
Cerebellar or brain stem laceration without mention of open intracranial wound, unspecified state of consciousness.
Cerebellar or brain stem laceration with open intracranial wound, unspecified state of consciousness.
Other and unspecified cerebral laceration and contusion, without mention of open intracranial wound, unspecified state of
consciousness.
Subarachnoid hemorrhage following injury without mention of open intracranial wound, unspecified state of consciousness.
Subarachnoid hemorrhage following injury with open intracranial wound, unspecified state of consciousness.
Subdural hemorrhage following injury without mention of open intracranial wound, unspecified state of consciousness.
Subdural hemorrhage following injury with open intracranial wound, unspecified state of consciousness.
Extradural hemorrhage following injury without mention of open intracranial wound, unspecified state of consciousness.
Extradural hemorrhage following injury with open intracranial wound, unspecified state of consciousness.
Other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound, unspecified state
of consciousness.
Other and unspecified intracranial hemorrhage following injury with open intracranial wound, unspecified state of consciousness.
Intracranial injury of other and unspecified nature without mention of open intracranial wound, unspecified state of consciousness.
Intracranial injury of other and unspecified nature with open intracranial wound, unspecified state of consciousness.
** This table includes ICD–9–CM codes that were proposed (Table 7) in the May 8, 2013 proposed rule for removal from ‘‘ICD–9–CM Codes
That Meet Presumptive Compliance Criteria,’’ but we have determined should be retained.
tkelley on DSK3SPTVN1PROD with RULES2
2. Arthritis Codes
Our analysis of the list of ICD–9–CM
codes that are currently included in the
presumptive methodology list revealed
utilization patterns that indicated that
these codes were used far more
frequently than we had anticipated. We
also realized that such codes did not
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
provide any information as to whether
the patients met the severity and prior
treatment requirement portions of the
criteria for the medical conditions that
may be counted toward an IRF’s
compliance percentage under the
presumptive compliance method. We
did not adopt any and all arthritis
conditions in the May 7, 2004 final rule
PO 00000
Frm 00029
Fmt 4701
Sfmt 4700
(69 FR 25752). Rather, we only provided
for those patients with certain kinds of
arthritic conditions that met defined
severity and prior treatment
requirements. We anticipated that less
severe arthritic conditions could be
satisfactorily managed outside of IRFs
since these cases would not require the
intensive therapy provided in the
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47888
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
inpatient rehabilitation setting. As we
realized on reflection that there is no
way to tell base on an arthritis ICD–9–
CM code alone whether an individual
met the severity and prior treatment
requirements outlined in regulation, we
realized that factors beyond the ICD–9–
CM code would need to be reviewed to
establish whether these IRF patients
should be included in the IRF’s
compliance percentage.
Specifically, the regulations under
§ 412.29(b)(2)(x) through
§ 412.29(b)(2)(xii), describe the
following three (3) ‘‘arthritis’’ medical
conditions that, if present, and all of the
described circumstances are met, would
make a patient eligible for inclusion in
the presumptive compliance calculation
of the IRF’s compliance percentage. The
3 medical conditions are as follows:
• Active, polyarticular rheumatoid
arthritis, psoriatic arthritis, and
seronegative arthropathies resulting in
significant functional impairment of
ambulation and other activities of daily
living that have not improved after an
appropriate, aggressive, and sustained
course of outpatient therapy services or
services in other less intensive
rehabilitation settings immediately
preceding the inpatient rehabilitation
admission or that result from a systemic
disease activation immediately before
admission, but have the potential to
improve with more intensive
rehabilitation.
• Systemic vasculidities with joint
inflammation, resulting in significant
functional impairment of ambulation
and other activities of daily living that
have not improved after an appropriate,
aggressive, and sustained course of
outpatient therapy services or services
in other less intensive rehabilitation
settings immediately preceding the
inpatient rehabilitation admission or
that result from a systemic disease
activation immediately before
admission, but have the potential to
improve with more intensive
rehabilitation.
• Severe or advanced osteoarthritis
(osteoarthrosis or degenerative joint
disease) involving two or more major
weight bearing joints (elbow, shoulders,
hips, or knees, but not counting a joint
with a prosthesis) with joint deformity
and substantial loss of range of motion,
atrophy of muscles surrounding the
joint, significant functional impairment
of ambulation and other activities of
daily living that have not improved after
the patient has participated in an
appropriate, aggressive, and sustained
course of outpatient therapy services or
services in other less intensive
rehabilitation settings immediately
preceding the inpatient rehabilitation
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
admission but have the potential to
improve with more intensive
rehabilitation. (A joint replaced by a
prosthesis is no longer is considered to
have osteoarthritis, or other arthritis,
even though this condition was the
reason for the joint replacement.)
As stated above, the inclusion of
patients with these medical conditions
in the presumptive compliance
calculation of the IRF’s compliance
percentage is conditioned on those
patients meeting the described severity
and prior treatment requirements.
However, the ICD–9–CM diagnosis
codes that reflect these arthritis and
arthropathy conditions do not provide
any information about whether these
additional elements of the regulatory
criteria were met. We therefore believe
that additional information beyond the
presence of the code is necessary to
determine if the medical record would
support inclusion of individuals with
the arthritis and arthropathy conditions
outlined in our regulations under
§ 412.29(b)(2)(x) through
§ 412.29(b)(2)(xii) in the presumptive
compliance calculation of the facility’s
compliance percentage. Thus, we
proposed to remove the ICD–9–CM
diagnosis codes associated with the
medical conditions outlined in our
regulations under § 412.29(b)(2)(x)
through § 412.29(b)(2)(xii) from the
presumptive methodology list.
We expect that the MACs will be able,
upon medical review, to include those
patients in a facility’s 60 percent rule
compliance after it has confirmed the
severity and prior treatment portions of
the criteria. As such, IRFs would
continue to be able to have these
individuals included in the medical
review calculation of their compliance
percentages. In Table 9, we list the ICD–
9–CM codes associated with the medical
conditions listed under § 412.29(b)(2)(x)
through § 412.29(b)(2)(xii) that we will
remove from the list, ICD–9–CM Codes
That Meet Presumptive Compliance
Criteria.
We received 11 comments on the
proposed changes to arthritis diagnosis
codes listed in ICD–9–CM Codes That
Meet Presumptive Compliance Criteria,
which are summarized below.
Comment: One commenter suggested
that the proposed changes to the
presumptive methodology list and the
removal of the arthritis codes will
increase the use of the medical review
method, which is more burdensome for
both CMS and for IRFs. Several
commenters suggested that the facility
should not have to undergo a ‘‘full
medical review’’ if it failed to meet the
required compliance percentage using
the presumptive compliance method.
PO 00000
Frm 00030
Fmt 4701
Sfmt 4700
Instead, they suggested use of a ‘‘limited
medical review’’ in which only arthritis
and systemic vasculidities cases would
be reviewed. The commenters further
stated that, should a sufficient number
of cases from the ‘‘limited review’’ be
determined to meet criteria, these
‘‘passing’’ records would be added to
the ‘‘numerator’’ of the presumptive
calculation result to arrive at a
compliance percentage equal at least 60
percent. In this manner the facility
would be deemed compliant without
needing a ‘‘full medical review.’’
However, if the IRF failed to meet
criteria with this ‘‘limited review,’’ the
MAC could then perform a ‘‘full
medical review.’’
Response: We acknowledge that
because of the removal of the arthritis
codes from the list of codes that are
used to determine presumptive
compliance under the ‘‘60 percent’’ rule,
some facilities may not be able to reach
the minimum compliance percentage
using presumptive compliance method.
In the May 8, 2013 proposed rule, we
suggested that upon medical review (in
accordance with chapter 3, section
140.1.4 of the Medicare Claims
Processing Manual (Pub. 100–04)), after
which the MAC will have been able to
determine that severity and
pretreatment requirements have been
met, these patients would be included
in the calculation of a facility’s 60
percent rule compliance percentage.
Assuming providers make no other
changes, we estimate that the removal of
the arthritis and arthropathy codes will
result in approximately 40 facilities
failing to meet the 60 percent threshold
using the presumptive compliance
method, and would have to instead be
evaluated under the medical review
method. We assume that all of these
facilities would obtain a satisfactory
compliance percentage after medical
review, as we assume that the patients
that will be coded with the to-be
removed arthritis and arthropathy codes
will meet the severity and prior
treatment requirements. Thus, we
believe that few, if any facilities will
ultimately lose their IRF classification
by virtue of these changes.
We appreciate the commenter’s
suggestions regarding the use of a
modified medical review limited to only
arthritis and systemic vasculidities
cases to determine if patients have met
severity and pretreatment requirements,
in lieu of full medical review carried out
in accordance with chapter 3, section
140.1.3(D), of the Medicare Claims
Processing Manual (Pub. 100–04). We
will use the time afforded by our oneyear delay (that is, the application of the
changes to the list will not apply to
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
compliance review periods beginning
before October 1, 2014) to consider the
feasibility of minimizing any burdens
created by the operational aspects of
this policy.
Comment: One commenter expressed
concern that in response to our proposal
to remove arthritis codes from the ICD–
9–CM Codes That Meet Presumptive
Compliance Criteria list and no longer
count them as part of the presumptive
methodology, IRFs will seek to avoid
‘‘unnecessary’’ medical review by
modifying their admission criteria so as
to limit the admission of patients with
arthritis conditions. The commenter
also stated that our proposed removal of
the arthritis codes from the list of
presumptive ICD–9–CM codes that meet
compliance criteria ‘‘was as if’’ we
removed arthritis and arthropathy
conditions from the 13 qualifying
medical conditions outlined in
regulation.
Response: Although we agree that it is
plausible that some IRFs might seek to
avoid the possibility of medical review
by limiting admission of patients with
arthritis conditions, this is not our
intent. Our intent behind this policy is
to ensure that we have enough
information to ensure patients with
arthritis conditions who are counted as
meeting the compliance criteria in
412.29(b) are appropriately meeting the
severity and prior treatment
requirements, as per the regulation. We
disagree that the proposed changes to
the presumptive methodology list
equates with the removal of arthritis and
arthropathy conditions from the 13
qualifying medical conditions outlined
in regulation. As discussed in the
proposed rule’s preamble and in prior
discussion in this preamble, when we
adopted the arthritis and arthropathy
conditions in the May 7, 2004 final rule,
we limited the conditions to those that
met defined severity and prior treatment
requirements, and that were sufficiently
severe as to require intensive inpatient
rehabilitation services. As discussed
above, ICD–9–CM diagnosis codes alone
do not provide sufficient information to
establish whether these pretreatment
and severity requirements have been
met. More detailed information is
necessary to determine if the patient
meets the pretreatment and severity
requirements. Verification using the
medical review compliance method will
allow an IRF to have these patients
included in their compliance
percentage. Thus, arthritis conditions
will continue to be included in the
calculation of compliance percentages
in accordance with the 13 qualifying
medical conditions in the regulations.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
3. Some Congenital Anomaly Diagnosis
Codes
Though congenital deformity is one of
the 13 medical conditions that may,
subject to the limitations spelled out in
the regulations, qualify for inclusion in
the calculation of an IRF’s compliance
percentage under the 60 percent rule,
certain congenital anomalies represent
such serious conditions that a patient
with one of these conditions would
generally not be expected to be able to
meaningfully participate in an intensive
rehabilitation therapy program. For
example, Craniorachischisis (ICD–9–CM
code 740.1) is a congenital malformation
where the neural tube from the
midbrain down to the upper sacral
region of the spinal cord remains open.
The neural tube is the embryo’s
precursor to the central nervous system,
which comprises the brain and spinal
cord. Similarly, Iniencephaly (ICD–9–
CD code 740.2) is a congenital
malformation in which parts of the
brain do not form and the patient does
not have a neck. Because beneficiaries
with these diagnoses likely would
generally not be expected to be able to
actively participate in an intensive
rehabilitation program, we do not
believe that we can include such cases
in an IRF’s presumptive compliance
percentage. That said, as we noted in
the proposed rule, if a patient with one
of these conditions were able to
participate in the intensive
rehabilitation services provided in an
IRF, then the MAC would be able to
count that case toward an IRF’s 60
percent rule compliance percentage
upon medical review. Thus, we
proposed the removal of these
congenital deformity codes, and others
that present similar concerns that were
discussed in the proposed rule from the
presumptive compliance list.
We received 4 comments on the
proposed changes to the congenital
anomaly diagnosis codes, which are
summarized below.
Comment: The commenters supported
our proposal to remove the specified
congenital anomaly conditions from the
presumptive methodology list. These
commenters noted that these conditions
are rare and agreed that patients with
these conditions would be unlikely to
require or to meaningfully participate in
intensive inpatient rehabilitation
services.
Response: We thank the commenters
for supporting our efforts to refine the
presumptive methodology list so that
the list truly represents diagnoses that
would be expected to indicate that an
individual meets the medical condition
criteria, and that they should be
PO 00000
Frm 00031
Fmt 4701
Sfmt 4700
47889
included in an IRF’s compliance
percentage under the presumptive
compliance method of calculating a
compliance percentage. All of the
congenital anomaly diagnosis codes that
we are removing from ICD–9–CM Codes
That Meet Presumptive Compliance
Criteria list are listed in Table 9.
4. Unilateral Upper Extremity
Amputations Diagnosis Codes
Though amputation is generally one
of the 13 medical conditions that qualify
for inclusion in the an IRF’s compliance
calculation for the 60 percent rule, we
proposed the removal of certain ICD–9–
CM codes for unilateral upper extremity
amputations from the presumptive
methodology list, ICD–9–CM Codes
That Meet Presumptive Compliance
Criteria, because we believe that it is
impossible to determine, from the
presence of such ICD–9–CM codes
alone, whether a patient with such a
unilateral upper extremity amputation
has a condition for which he or she
would need intensive rehabilitation
services for treatment of one or more of
the conditions specified in
§ 412.29(b)(2). We expect that some
patients with these upper extremity
amputations will not require close
medical supervision by a physician or
weekly interdisciplinary team
conferences to achieve their goals, while
others may require these services. But
we generally believe that rehabilitation
associated with unilateral upper
extremity amputations would not need
to be accompanied by the close medical
management provided in IRFs, as long
as the patient does not have any
additional comorbidities that have
caused significant decline in his or her
functional ability that, in the absence of
the unilateral upper extremity
amputation, would necessitate
treatment in an IRF. That is to say, a
patient’s need for intensive
rehabilitation services provided in an
IRF depends on other conditions which
cannot be solely identified through the
presence of a unilateral upper extremity
amputation ICD–9–CM code. If the
patient has comorbidities that would
necessitate treatment in an IRF, then
those comorbidities would qualify the
patient for inclusion under the
presumptive compliance method of
calculating compliance with the 60
percent rule if one or more of the
comorbidities are on the presumptive
methodology list. If the codes for such
a patient’s comorbidities do not appear
in the presumptive compliance list, the
patient can still be considered for
inclusion in the IRF’s compliance
percentage following medical review
and confirmation that they meet the
E:\FR\FM\06AUR2.SGM
06AUR2
47890
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
criteria for one or more of the medical
conditions in the regulations. Thus, we
proposed to remove the unilateral upper
extremity amputation from the
presumptive methodology list.
We received 5 comments on the
proposed changes to unilateral upper
extremity amputation diagnosis codes
listed in ICD–9–CM Codes That Meet
Presumptive Compliance Criteria,
which are summarized below.
Comment: Several commenters
supported our proposal to remove
unilateral upper extremity amputation
codes from ICD–9–CM Codes That Meet
Presumptive Compliance. The
commenters agreed with our assessment
that a patient’s need for intensive
inpatient rehabilitative services for the
treatment of one or more of these
conditions would depend on the
presence of additional comorbidities
that caused significant decline in his or
her functional ability to the extent that
the patient would necessitate treatment
in an IRF. However, one commenter
disagreed with the proposal because an
inpatient setting offering an intensive
rehabilitation therapy program would be
appropriate for the acute phase of
wound healing, edema control, and
desensitization and pain control that
these patients may require.
Response: We agree that unilateral
upper extremity amputation patients
have ongoing therapy needs and may
require medical aftercare once
discharged from an acute hospital stay.
However, as long as the patient does not
have any other comorbidities that have
caused significant decline in his or her
functional ability that, in the absence of
the unilateral upper extremity
amputation, would require treatment in
an IRF, we do not believe that the
patient could be presumed to meet the
regulatory requirements for inclusion in
an IRF’s compliance percentage.
tkelley on DSK3SPTVN1PROD with RULES2
5. Miscellaneous Diagnosis Codes That
Do Not Require Intensive Rehabilitation
Services for Treatment
We have identified additional ICD–9–
CM diagnosis codes in the presumptive
methodology list, ICD–9–CM Codes
That Meet Presumptive Compliance
Criteria, which do not, in the absence of
additional confirmatory information,
indicate a patient’s need for intensive
rehabilitation services or that they have
met any severity or prerequisite
treatment requirements for the medical
conditions that may be counted toward
an IRF’s compliance percentage. We
therefore proposed removal of the
following ICD–9–CM codes from the
list, ICD–9–CM Codes That Meet
Presumptive Compliance Criteria.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
• Tuberculous (abscess, meningitis,
and encephalitis or myelitis) and
Tuberculoma (of the meninges, brain, or
spinal cord) where a bacterial or
histological examination is unspecified
or was not done (see Table 7 in the
proposed rule for a list of the specific
codes)—Appropriate patient care
dictates that the IRF physician must
attempt to ascertain the means by which
the organism, whether it be
bacteriologic or histologic, was tested.
We expect the IRF physician to make a
good faith effort to determine the type
of diagnostic test which identified the
tuberculous organism. In the
circumstances where this is impossible
(that is, documentation no longer
exists), appropriate codes remain on the
presumptive methodology list.
However, we expect the IRF physician
to make a good faith effort to determine
the type of diagnostic test which
identified the tuberculous organism. We
therefore proposed to remove these
unspecified codes from the list, ICD–9–
CM Codes That Meet Presumptive
Compliance Criteria.
• Postherpetic polyneuropathy
(053.13)—This is a condition
characterized by severe pain, which
typically requires pain medication or
other pain control therapies but does
not typically require the intensive
inpatient rehabilitation services of an
IRF. In fact, the prescriptive hands-on
therapeutic interventions provided in an
IRF could exacerbate the patient’s pain.
For these reasons, we proposed the
removal of this code from ICD–9–CM
Codes That Meet Presumptive
Compliance Criteria.
• Louping ill (063.1)—This ICD–9–
CM code refers to an acute viral disease
primarily of sheep that is not endemic
to the United States. Louping ill disease
has been recognized in Scotland for
centuries, but only 39 cases of human
infection have been described and none
of these cases have been observed in the
United States. Louping ill is a disease
which has many manifestations, not all
requiring inpatient rehabilitation
hospital services. We believe that the
ICD–9–CM code for this diagnosis does
not provide the information necessary
for us to determine presumptively
whether the patient has met the criteria
for the medical conditions that may be
counted toward an IRF’s compliance
percentage. However, as with all of the
codes that we proposed removing from
the list, ICD–9–CM Codes That Meet
Presumptive Compliance Criteria, if
someone with this diagnosis were to be
admitted to an IRF, medical review
could be used to confirm whether the
regulatory criteria have been met.
PO 00000
Frm 00032
Fmt 4701
Sfmt 4700
• Brain death (348.82)—We believe
that it is unlikely that a patient with this
condition would require the intensive
inpatient rehabilitation services
provided in an IRF. For this reason, we
proposed the removal of this code from
ICD–9–CM Codes That Meet
Presumptive Compliance Criteria.
• Myasthenia gravis without (acute)
exacerbation (358.00)—Although we
believe that a patient experiencing an
acute attack of Myasthenia Gravis could
potentially require the intensive
inpatient rehabilitative services of an
IRF (these individuals are coded with
ICD–9 code 358.01 ‘‘Myasthenia gravis
with (acute) exacerbation’’), we
proposed the removal of non-acute
myasthenia gravis from the list, ICD–9–
CM Codes That Meet Presumptive
Compliance Criteria because such
patients would not be experiencing an
acute exacerbation of the condition and
most likely would not require the
intensive inpatient rehabilitation
services provided in an IRF.
• Other specified myotonic disorder
(359.29)—codes patients with Myotonia
fluctuans, myotonia permanens, and
paramyotonia congenital which are
conditions that are exacerbated by
exercise. The intensive inpatient
rehabilitation services of an IRF would
be expected to exacerbate these
conditions, so such care would likely be
contraindicated. Therefore, we proposed
the removal of this code from the list,
ICD–9–CM Codes That Meet
Presumptive Compliance Criteria.
• Periodic paralysis (359.3)—The
treatment for periodic paralysis involves
pharmaceutical interventions and
lifestyle changes that control exercise
and activity, but patients with this
condition do not generally require the
intensive inpatient rehabilitation
services of an IRF. In fact, it is unclear
how the intensive inpatient
rehabilitation services provided in an
IRF would effectively treat this
condition. Thus, we proposed the
removal of this code from the list, ICD–
9–CM Codes That Meet Presumptive
Compliance Criteria.
• Brachial plexus lesions (353.0)—
Care and treatment for this condition,
which affects an upper extremity in a
manner that typically does not require
close medical supervision by a
physician or weekly interdisciplinary
team meetings to reach the patient’s
goals, would not be expect to require the
intensive inpatient rehabilitation
services provided in an IRF. Therefore,
we proposed the removal of this code
from the list, ICD–9–CM Codes That
Meet Presumptive Compliance Criteria.
• Neuralgic amyothrophy (353.5)—
This condition is also known as
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
Parsonage-Turner syndrome or brachial
plexus neuritis. It is a distinct
peripheral nervous system disorder
characterized by attacks of extreme
neuropathic pain and rapid multifocal
weakness and atrophy in the upper
limbs. Patients with this condition do
not typically require close medical
supervision by a physician or weekly
interdisciplinary team meetings to reach
the patient’s therapy goals. Thus,
patients with this condition do not
typically require the intensive inpatient
rehabilitation services provided in an
IRF. Therefore, we proposed the
removal of this code from the list, ICD–
9–CM Codes That Meet Presumptive
Compliance Criteria.
• Other nerve root and plexus
disorders (353.8)—This code does not,
in the absence of additional
information, reveal whether a patient is
in need of intensive rehabilitation
services for treatment of one or more of
the conditions specified in the
regulations. More descriptive codes
should be used so as to document the
appropriateness of a patient’s IRF
admission, and potentially, their
inclusion in the IRF’s compliance
percentage. For example, Lumbosacral
plexus lesions (353.1) could substitute
for Other nerve root and plexus
disorders (353.8). Patients with
lumbosacral plexus lesions, however, do
not typically require the intensive
inpatient rehabilitation services
provided in an IRF. Therefore, we
proposed the removal of this code from
the list, ICD–9–CM Codes That Meet
Presumptive Compliance Criteria.
We received 3 comments on the
proposed changes to the miscellaneous
diagnosis codes that we proposed
removing from the presumptive
methodology list in the proposed rule.
These are summarized below.
Comment: The commenters agreed
with the proposed removal of the
miscellaneous diagnosis codes that were
discussed in the May 8, 2013 proposed
rule.
Response: We appreciate the
commenters support and thank them for
their comments.
6. Additional Diagnosis Codes
During our review of the diagnosis
codes on the presumptive methodology
list we did not identify any ICD–9–CM
codes that would be appropriate to add
to the list. However, we welcomed
public comment regarding ICD–9–CM
diagnosis codes that are not currently on
the presumptive methodology list that
stakeholders believe should be added.
We noted that any such suggested codes
would have to code for one of the
medical conditions listed at
§ 412.29(b)(2) (including any severity or
pretreatment requirements), and require
intensive inpatient rehabilitation.
We received one comment suggesting
additional diagnosis codes not currently
listed in ICD–9–CM Codes That Meet
Presumptive Compliance Criteria..
Comment: The commenter suggested
that we add ICD–9–CM code 348.31—
Metabolic encephalopathy and ICD–9–
47891
CM code 331.83—Parkinson’s
Dementia—to the list of qualifying
codes.
Response: We agree that code ICD–9–
CM code 348.31—Metabolic
encephalopathy— should be added to
the list with the other toxic
encephalopathy codes to ensure that
IRFs can code to the highest level of
specificity. We will add this code to the
list of ICD–9–CM Codes That Meet
Presumptive Compliance Criteria.
However, we disagree with the
commenter’s suggestion to add
Parkinson’s Dementia to the list of codes
because we cannot determine
‘‘presumptively’’ whether these patients
would be able to meaningfully
participate in an intensive inpatient
rehabilitation program.
Final Decision: After carefully
considering the comments that we
received on the proposed changes to the
ICD–9–CM in the presumptive
methodology list, we are revising the list
of ICD–9–CM codes to be removed from
‘‘ICD–9–CM Codes That Meet
Presumptive Compliance Criteria’’ as
follows: We are removing the codes
listed in Table 9 of this final rule. We
are also adding ICD–9–CM code
348.31—Metabolic encephalopathy to
the presumptive methodology list. The
revisions to the list of diagnosis codes
that are used to determine presumptive
compliance under the ‘‘60 percent rule’’
are effective for compliance review
periods beginning on or after October 1,
2014.
TABLE 9—ICD–9–CM CODES REMOVED FROM ‘‘ICD–9–CM CODES THAT MEET PRESUMPTIVE COMPLIANCE CRITERIA’’
tkelley on DSK3SPTVN1PROD with RULES2
ICD–9–CM
Code
Diagnosis
013.00 ...............
013.01 ...............
013.10 ...............
013.11 ...............
013.20 ...............
013.21 ...............
013.30 ...............
013.31 ...............
013.40 ...............
013.41 ...............
013.50 ...............
013.51 ...............
013.60 ...............
013.61 ...............
047.9 .................
053.13 ...............
062.9 .................
063.1 .................
063.9 .................
324.9 .................
335.10 ...............
335.9 .................
336.9 .................
341.9 .................
342.00 ...............
342.10 ...............
VerDate Mar<15>2010
Tuberculous meningitis, unspecified.
Tuberculous meningitis, bacteriological or histological examination not done.
Tuberculoma of meninges, unspecified.
Tuberculoma of meninges, bacteriological or histological examination not done.
Tuberculoma of brain, unspecified.
Tuberculoma of brain, bacteriological or histological examination not done.
Tuberculous abscess of brain, unspecified.
Tuberculous abscess of brain, bacteriological or histological examination not done.
Tuberculoma of spinal cord, unspecified.
Tuberculoma of spinal cord, bacteriological or histological examination not done.
Tuberculous abscess of spinal cord, unspecified.
Tuberculous abscess of spinal cord, bacteriological or histological examination not done.
Tuberculous encephalitis or myelitis, unspecified.
Tuberculous encephalitis or myelitis, bacteriological or histological examination not done.
Unspecified viral meningitis.
Postherpetic polyneuropathy.
Mosquito-borne viral encephalitis, unspecified.
Louping ill.
Tick-borne viral encephalitis, unspecified.
Intracranial and intraspinal abscess of unspecified site.
Spinal muscular atrophy, unspecified.
Anterior horn cell disease, unspecified.
Unspecified disease of spinal cord.
Demyelinating disease of central nervous system, unspecified.
Flaccid hemiplegia and hemiparesis affecting unspecified side.
Spastic hemiplegia and hemiparesis affecting unspecified side.
19:58 Aug 05, 2013
Jkt 229001
PO 00000
Frm 00033
Fmt 4701
Sfmt 4700
E:\FR\FM\06AUR2.SGM
06AUR2
47892
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
TABLE 9—ICD–9–CM CODES REMOVED FROM ‘‘ICD–9–CM CODES THAT MEET PRESUMPTIVE COMPLIANCE CRITERIA’’—
Continued
tkelley on DSK3SPTVN1PROD with RULES2
ICD–9–CM
Code
Diagnosis
342.80 ...............
342.90 ...............
342.91 ...............
342.92 ...............
343.3 .................
344.5 .................
348.82 ...............
353.0 .................
353.2 .................
353.3 .................
353.4 .................
353.5 .................
353.8 .................
354.5 .................
356.9 .................
358.00 ...............
359.29 ...............
359.3 .................
432.9 .................
438.20 ...............
438.30 ...............
438.31 ...............
438.32 ...............
438.40 ...............
438.50 ...............
446.0 .................
711.20 ...............
711.21 ...............
711.22 ...............
711.23 ...............
711.24 ...............
711.25 ...............
711.26 ...............
711.27 ...............
711.28 ...............
711.29 ...............
713.0 .................
713.1 .................
713.2 .................
713.3 .................
713.4 .................
713.6 .................
713.7 .................
714.0 .................
714.1 .................
714.2 .................
714.32 ...............
714.81 ...............
714.89 ...............
714.9 .................
715.11 ...............
715.12 ...............
715.15 ...............
715.16 ...............
715.21 ...............
715.22 ...............
715.25 ...............
715.26 ...............
715.31 ...............
715.32 ...............
715.35 ...............
715.36 ...............
716.01 ...............
716.02 ...............
716.05 ...............
716.06 ...............
716.11 ...............
716.12 ...............
716.15 ...............
716.16 ...............
VerDate Mar<15>2010
Other specified hemiplegia and hemiparesis affecting unspecified side.
Hemiplegia, unspecified, affecting unspecified side.
Hemiplegia, unspecified, affecting dominant side.
Hemiplegia, unspecified, affecting nondominant side.
Congenital monoplegia.
Unspecified monoplegia.
Brain death.
Brachial plexus lesions.
Cervical root lesions, not elsewhere classified.
Thoracic root lesions, not elsewhere classified.
Lumbosacral root lesions, not elsewhere classified.
Neuralgic amyotrophy.
Other nerve root and plexus disorders.
Mononeuritis multiplex.
Unspecified hereditary and idiopathic peripheral neuropathy.
Myasthenia gravis without (acute) exacerbation.
Other specified myotonic disorder.
Periodic paralysis.
Unspecified intracranial hemorrhage.
Late effects of cerebrovascular disease, hemiplegia affecting unspecified side.
Late effects of cerebrovascular disease, monoplegia of upper limb affecting unspecified side.
Late effects of cerebrovascular disease, monoplegia of upper limb affecting dominant side.
Late effects of cerebrovascular disease, monoplegia of upper limb affecting nondominant side.
Late effects of cerebrovascular disease, monoplegia of lower limb affecting unspecified side.
Late effects of cerebrovascular disease, other paralytic syndrome affecting unspecified side.
Polyarteritis nodosa.
Arthropathy in Behcet’s syndrome, site unspecified.
Arthropathy in Behcet’s syndrome, shoulder region.
Arthropathy in Behcet’s syndrome, upper arm.
Arthropathy in Behcet’s syndrome, forearm.
Arthropathy in Behcet’s syndrome, hand.
Arthropathy in Behcet’s syndrome, pelvic region and thigh.
Arthropathy in Behcet’s syndrome, lower leg.
Arthropathy in Behcet’s syndrome, ankle and foot.
Arthropathy in Behcet’s syndrome, other specified sites.
Arthropathy in Behcet’s syndrome, multiple sites.
Arthropathy associated with other endocrine and metabolic disorders.
Arthropathy associated with gastrointestinal conditions other than infections.
Arthropathy associated with hematological disorders.
Arthropathy associated with dermatological disorders.
Arthropathy associated with respiratory disorders.
Arthropathy associated with hypersensitivity reaction.
Other general diseases with articular involvement.
Rheumatoid arthritis.
Felty’s syndrome.
Other rheumatoid arthritis with visceral or systemic involvement.
Pauciarticular juvenile rheumatoid arthritis.
Rheumatoid lung.
Other specified inflammatory polyarthropathies.
Unspecified inflammatory polyarthropathy.
Osteoarthrosis, localized, primary, shoulder region.
Osteoarthrosis, localized, primary, upper arm.
Osteoarthrosis, localized, primary, pelvic region and thigh.
Osteoarthrosis, localized, primary, lower leg.
Osteoarthrosis, localized, secondary, shoulder region.
Osteoarthrosis, localized, secondary, upper arm.
Osteoarthrosis, localized, secondary, pelvic region and thigh.
Osteoarthrosis, localized, secondary, lower leg.
Osteoarthrosis, localized, not specified whether primary or secondary, shoulder region.
Osteoarthrosis, localized, not specified whether primary or secondary, upper arm.
Osteoarthrosis, localized, not specified whether primary or secondary, pelvic region and thigh.
Osteoarthrosis, localized, not specified whether primary or secondary, lower leg.
Kaschin-Beck disease, shoulder region.
Kaschin-Beck disease, upper arm.
Kaschin-Beck disease, pelvic region and thigh.
Kaschin-Beck disease, lower leg.
Traumatic arthropathy, shoulder region.
Traumatic arthropathy, upper arm.
Traumatic arthropathy, pelvic region and thigh.
Traumatic arthropathy, lower leg.
19:58 Aug 05, 2013
Jkt 229001
PO 00000
Frm 00034
Fmt 4701
Sfmt 4700
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
47893
TABLE 9—ICD–9–CM CODES REMOVED FROM ‘‘ICD–9–CM CODES THAT MEET PRESUMPTIVE COMPLIANCE CRITERIA’’—
Continued
tkelley on DSK3SPTVN1PROD with RULES2
ICD–9–CM
Code
Diagnosis
716.21 ...............
716.22 ...............
716.25 ...............
716.26 ...............
716.51 ...............
716.52 ...............
716.55 ...............
716.56 ...............
719.30 ...............
719.31 ...............
719.32 ...............
719.33 ...............
719.34 ...............
719.35 ...............
719.36 ...............
719.37 ...............
719.38 ...............
719.39 ...............
720.0 .................
720.81 ...............
720.89 ...............
721.91 ...............
722.70 ...............
740.1 .................
740.2 .................
741.00 ...............
741.90 ...............
742.1 .................
754.30 ...............
754.31 ...............
754.32 ...............
755.20 ...............
755.21 ...............
755.22 ...............
755.23 ...............
755.24 ...............
755.25 ...............
755.26 ...............
755.27 ...............
755.28 ...............
755.30 ...............
755.4 .................
755.51 ...............
755.53 ...............
755.61 ...............
755.62 ...............
755.63 ...............
756.50 ...............
800.09 ...............
800.19 ...............
800.29 ...............
800.39 ...............
800.49 ...............
800.59 ...............
800.69 ...............
800.79 ...............
800.89 ...............
800.99 ...............
801.09 ...............
801.19 ...............
801.29 ...............
801.39 ...............
801.49 ...............
801.59 ...............
801.69 ...............
801.79 ...............
801.89 ...............
801.99 ...............
803.09 ...............
803.19 ...............
VerDate Mar<15>2010
Allergic arthritis, shoulder region.
Allergic arthritis, upper arm.
Allergic arthritis, pelvic region and thigh.
Allergic arthritis, lower leg.
Unspecified polyarthropathy or polyarthritis, shoulder region.
Unspecified polyarthropathy or polyarthritis, upper arm.
Unspecified polyarthropathy or polyarthritis, pelvic region and thigh.
Unspecified polyarthropathy or polyarthritis, lower leg.
Palindromic rheumatism, site unspecified.
Palindromic rheumatism, shoulder region.
Palindromic rheumatism, upper arm.
Palindromic rheumatism, forearm.
Palindromic rheumatism, hand.
Palindromic rheumatism, pelvic region and thigh.
Palindromic rheumatism, lower leg.
Palindromic rheumatism, ankle and foot.
Palindromic rheumatism, other specified sites.
Palindromic rheumatism, multiple sites.
Ankylosing spondylitis.
Inflammatory spondylopathies in diseases classified elsewhere.
Other inflammatory spondylopathies.
Spondylosis of unspecified site, with myelopathy.
Intervertebral disc disorder with myelopathy, unspecified region.
Craniorachischisis.
Iniencephaly.
Spina bifida with hydrocephalus, unspecified region.
Spina bifida without mention of hydrocephalus, unspecified region.
Microcephalus.
Congenital dislocation of hip, unilateral.
Congenital dislocation of hip, bilateral.
Congenital subluxation of hip, unilateral.
Unspecified reduction deformity of upper limb.
Transverse deficiency of upper limb.
Longitudinal deficiency of upper limb, not elsewhere classified.
Longitudinal deficiency, combined, involving humerus, radius, and ulna (complete or incomplete).
Longitudinal deficiency, humeral, complete or partial (with or without distal deficiencies, incomplete).
Longitudinal deficiency, radioulnar, complete or partial (with or without distal deficiencies, incomplete).
Longitudinal deficiency, radial, complete or partial (with or without distal deficiencies, incomplete).
Longitudinal deficiency, ulnar, complete or partial (with or without distal deficiencies, incomplete).
Longitudinal deficiency, carpals or metacarpals, complete or partial (with or without incomplete phalangeal deficiency).
Unspecified reduction deformity of lower limb.
Reduction deformities, unspecified limb.
Congenital deformity of clavicle.
Radioulnar synostosis.
Coxa valga, congenital.
Coxa vara, congenital.
Other congenital deformity of hip (joint).
Congenital osteodystrophy, unspecified.
Closed fracture of vault of skull without mention of intracranial injury, with concussion, unspecified.
Closed fracture of vault of skull with cerebral laceration and contusion, with concussion, unspecified.
Closed fracture of vault of skull with subarachnoid, subdural, and extradural hemorrhage, with concussion, unspecified.
Closed fracture of vault of skull with other and unspecified intracranial hemorrhage, with concussion, unspecified.
Closed fracture of vault of skull with intracranial injury of other and unspecified nature, with concussion, unspecified.
Open fracture of vault of skull without mention of intracranial injury, with concussion, unspecified.
Open fracture of vault of skull with cerebral laceration and contusion, with concussion, unspecified.
Open fracture of vault of skull with subarachnoid, subdural, and extradural hemorrhage, with concussion, unspecified.
Open fracture of vault of skull with other and unspecified intracranial hemorrhage, with concussion, unspecified.
Open fracture of vault of skull with intracranial injury of other and unspecified nature, with concussion, unspecified.
Closed fracture of base of skull without mention of intra cranial injury, with concussion, unspecified.
Closed fracture of base of skull with cerebral laceration and contusion, with concussion, unspecified.
Closed fracture of base of skull with subarachnoid, subdural, and extradural hemorrhage, with concussion, unspecified.
Closed fracture of base of skull with other and unspecified intracranial hemorrhage, with concussion, unspecified.
Closed fracture of base of skull with intracranial injury of other and unspecified nature, with concussion, unspecified.
Open fracture of base of skull without mention of intracranial injury, with concussion, unspecified.
Open fracture of base of skull with cerebral laceration and contusion, with concussion, unspecified.
Open fracture of base of skull with subarachnoid, subdural, and extradural hemorrhage, with concussion, unspecified.
Open fracture of base of skull with other and unspecified intracranial hemorrhage, with concussion, unspecified.
Open fracture of base of skull with intracranial injury of other and unspecified nature, with concussion, unspecified.
Other closed skull fracture without mention of intracranial injury, with concussion, unspecified.
Other closed skull fracture with cerebral laceration and contusion, with concussion, unspecified.
19:58 Aug 05, 2013
Jkt 229001
PO 00000
Frm 00035
Fmt 4701
Sfmt 4700
E:\FR\FM\06AUR2.SGM
06AUR2
47894
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
TABLE 9—ICD–9–CM CODES REMOVED FROM ‘‘ICD–9–CM CODES THAT MEET PRESUMPTIVE COMPLIANCE CRITERIA’’—
Continued
ICD–9–CM
Code
803.29
803.39
803.49
803.59
803.69
803.79
803.89
803.99
804.19
804.29
Diagnosis
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
804.39 ...............
804.49 ...............
804.69 ...............
804.79 ...............
804.89 ...............
804.99 ...............
806.00 ...............
806.05 ...............
806.10 ...............
806.15 ...............
806.20 ...............
806.25 ...............
806.30 ...............
806.35 ...............
806.60 ...............
806.70 ...............
820.8 .................
820.9 .................
839.10 ...............
850.5 .................
851.09 ...............
851.19 ...............
851.29 ...............
851.39 ...............
851.49 ...............
851.59 ...............
851.69 ...............
851.79 ...............
851.89 ...............
tkelley on DSK3SPTVN1PROD with RULES2
852.09
852.19
852.29
852.39
852.49
852.59
853.09
...............
...............
...............
...............
...............
...............
...............
853.19 ...............
854.09 ...............
854.19 ...............
887.0 .................
887.1 .................
887.2 .................
887.3 .................
887.4 .................
887.5 .................
941.00 ...............
941.02 ...............
941.09 ...............
942.00 ...............
942.01 ...............
942.02 ...............
942.03 ...............
VerDate Mar<15>2010
Other closed skull fracture with subarachnoid, subdural, and extradural hemorrhage, with concussion, unspecified.
Other closed skull fracture with other and unspecified intracranial hemorrhage, with concussion, unspecified.
Other closed skull fracture with intracranial injury of other and unspecified nature, with concussion, unspecified.
Other open skull fracture without mention of intracranial injury, with concussion, unspecified.
Other open skull fracture with cerebral laceration and contusion, with concussion, unspecified.
Other open skull fracture with subarachnoid, subdural, and extradural hemorrhage, with concussion, unspecified.
Other open skull fracture with other and unspecified intracranial hemorrhage, with concussion, unspecified.
Other open skull fracture with intracranial injury of other and unspecified nature, with concussion, unspecified.
Closed fractures involving skull or face with other bones, with cerebral laceration and contusion, with concussion, unspecified.
Closed fractures involving skull or face with other bones with subarachnoid, subdural, and extradural hemorrhage, with concussion, unspecified.
Closed fractures involving skull or face with other bones, with other and unspecified intracranial hemorrhage, with concussion,
unspecified.
Closed fractures involving skull or face with other bones, with intracranial injury of other and unspecified nature, with concussion, unspecified.
Open fractures involving skull or face with other bones, with cerebral laceration and contusion, with concussion, unspecified.
Open fractures involving skull or face with other bones with subarachnoid, subdural, and extradural hemorrhage, with concussion, unspecified.
Open fractures involving skull or face with other bones, with other and unspecified intracranial hemorrhage, with concussion,
unspecified.
Open fractures involving skull or face with other bones, with intracranial injury of other and unspecified nature, with concussion, unspecified.
Closed fracture of C1–C4 level with unspecified spinal cord injury.
Closed fracture of C5–C7 level with unspecified spinal cord injury.
Open fracture of C1–C4 level with unspecified spinal cord injury.
Open fracture of C5–C7 level with unspecified spinal cord injury.
Closed fracture of T1–T6 level with unspecified spinal cord injury.
Closed fracture of T7–T12 level with unspecified spinal cord injury.
Open fracture of T1–T6 level with unspecified spinal cord injury.
Open fracture of T7–T12 level with unspecified spinal cord injury.
Closed fracture of sacrum and coccyx with unspecified spinal cord injury.
Open fracture of sacrum and coccyx with unspecified spinal cord injury.
Closed fracture of unspecified part of neck of femur.
Open fracture of unspecified part of neck of femur.
Open dislocation, cervical vertebra, unspecified.
Concussion with loss of consciousness of unspecified duration.
Cortex (cerebral) contusion without mention of open intracranial wound, with concussion, unspecified.
Cortex (cerebral) contusion with open intracranial wound, with concussion, unspecified.
Cortex (cerebral) laceration without mention of open intracranial wound, with concussion, unspecified.
Cortex (cerebral) laceration with open intracranial wound, with concussion, unspecified.
Cerebellar or brain stem contusion without mention of open intracranial wound, with concussion, unspecified.
Cerebellar or brain stem contusion with open intracranial wound, with concussion, unspecified.
Cerebellar or brain stem laceration without mention of open intracranial wound, with concussion, unspecified.
Cerebellar or brain stem laceration with open intracranial wound, with concussion, unspecified.
Other and unspecified cerebral laceration and contusion, without mention of open intracranial wound, with concussion, unspecified.
Subarachnoid hemorrhage following injury without mention of open intracranial wound, with concussion, unspecified.
Subarachnoid hemorrhage following injury with open intracranial wound, with concussion, unspecified.
Subdural hemorrhage following injury without mention of open intracranial wound, with concussion, unspecified.
Subdural hemorrhage following injury with open intracranial wound, with concussion, unspecified.
Extradural hemorrhage following injury without mention of open intracranial wound, with concussion, unspecified.
Extradural hemorrhage following injury with open intracranial wound, with concussion, unspecified.
Other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound, with concussion,
unspecified.
Other and unspecified intracranial hemorrhage following injury with open intracranial wound, with concussion, unspecified.
Intracranial injury of other and unspecified nature without mention of open intracranial wound, with concussion, unspecified.
Intracranial injury of other and unspecified nature with open intracranial wound, with concussion, unspecified.
Traumatic amputation of arm and hand (complete) (partial), unilateral, below elbow, without mention of complication.
Traumatic amputation of arm and hand (complete) (partial), unilateral, below elbow, complicated.
Traumatic amputation of arm and hand (complete) (partial), unilateral, at or above elbow, without mention of complication.
Traumatic amputation of arm and hand (complete) (partial), unilateral, at or above elbow, complicated.
Traumatic amputation of arm and hand (complete) (partial), unilateral, level not specified, without mention of complication.
Traumatic amputation of arm and hand (complete) (partial), unilateral, level not specified, complicated.
Burn of unspecified degree of face and head, unspecified site.
Burn of unspecified degree of eye (with other parts of face, head, and neck).
Burn of unspecified degree of multiple sites [except with eye] of face, head, and neck.
Burn of unspecified degree of trunk, unspecified site.
Burn of unspecified degree of breast.
Burn of unspecified degree of chest wall, excluding breast and nipple.
Burn of unspecified degree of abdominal wall.
19:58 Aug 05, 2013
Jkt 229001
PO 00000
Frm 00036
Fmt 4701
Sfmt 4700
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
47895
TABLE 9—ICD–9–CM CODES REMOVED FROM ‘‘ICD–9–CM CODES THAT MEET PRESUMPTIVE COMPLIANCE CRITERIA’’—
Continued
ICD–9–CM
Code
942.04
942.05
942.09
943.00
943.01
943.02
943.03
943.04
943.05
943.06
943.09
943.30
943.40
943.50
944.30
944.40
944.50
945.00
945.01
945.02
945.03
945.04
945.05
945.06
945.09
945.20
945.40
Diagnosis
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
945.50 ...............
949.4 .................
949.5 .................
997.60 ...............
Burn of unspecified degree of back [any part].
Burn of unspecified degree of genitalia.
Burn of unspecified degree of other and multiple sites of trunk.
Burn of unspecified degree of upper limb, except wrist and hand, unspecified site.
Burn of unspecified degree of forearm.
Burn of unspecified degree of elbow.
Burn of unspecified degree of upper arm.
Burn of unspecified degree of axilla.
Burn of unspecified degree of shoulder.
Burn of unspecified degree of scapular region.
Burn of unspecified degree of multiple sites of upper limb, except wrist and hand.
Full-thickness skin [third degree, not otherwise specified] of upper limb, unspecified site.
Deep necrosis of underlying tissues [deep third degree] without mention of loss of a body part, of upper limb, unspecified site.
Deep necrosis of underlying tissues [deep third degree] with loss of a body part, of upper limb, unspecified site.
Full-thickness skin loss [third degree, not otherwise specified] of hand, unspecified site.
Deep necrosis of underlying tissues [deep third degree] without mention of loss of a body part, hand, unspecified site.
Deep necrosis of underlying tissues [deep third degree] with loss of a body part, of hand, unspecified site.
Burn of unspecified degree of lower limb [leg], unspecified site.
Burn of unspecified degree of toe(s) (nail).
Burn of unspecified degree of foot.
Burn of unspecified degree of ankle.
Burn of unspecified degree of lower leg.
Burn of unspecified degree of knee.
Burn of unspecified degree of thigh [any part].
Burn of unspecified degree of multiple sites of lower limb(s).
Blisters, epidermal loss [second degree] of lower limb [leg], unspecified site.
Deep necrosis of underlying tissues [deep third degree] without mention of loss of a body part, lower limb [leg], unspecified
site.
Deep necrosis of underlying tissues [deep third degree] with loss of a body part, of lower limb [leg], unspecified site.
Deep necrosis of underlying tissue [deep third degree] without mention of loss of a body part, unspecified.
Deep necrosis of underlying tissues [deep third degree] with loss of a body part, unspecified.
Unspecified complication of amputation stump.
tkelley on DSK3SPTVN1PROD with RULES2
IX. Non-Quality Related Revisions to
IRF–PAI Sections
Under section 1886(j)(2)(D) of the Act,
the Secretary is authorized to require
rehabilitation facilities that provide
inpatient hospital services to submit
such data as the Secretary deems
necessary to establish and administer
the prospective payment system under
subsection P. The collection of patient
data is indispensable for the successful
development and implementation of the
IRF payment system. In the August 7,
2001 final rule, the inpatient
rehabilitation facility patient assessment
instrument (IRF–PAI) was adopted as
the standardized patient assessment
instrument under the IRF prospective
payment system (PPS). The IRF–PAI
was established, and is still used to
gather data to classify patients for
payment under the IRF PPS. As
discussed in section XIV of this final
rule, it is also now used to collect
certain data for the IRF Quality
Reporting Program. IRFs are currently
required to complete an IRF–PAI for
every Medicare Part A or C patient who
is admitted to, or discharged from an
IRF. (We note that Medicare Part B was
inappropriately listed in the proposed
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
rule. We are clarifying that IRFs are not
required to submit the IRF–PAI for
Medicare Part B patients.)
Although there have been significant
advancements in the industry, no IRF
PPS payment-related changes have been
made to the IRF–PAI form since its
implementation in FY 2002. In the FY
2014 IRF PPS proposed rule, we
proposed amending certain response
code options, adding additional data
points, removing certain outdated items
and changing certain references to
ensure that our policies reflect the
current data needs of the IRF PPS
program.
A. Revisions
We proposed to amend the response
codes on the following items in the IRF–
PAI:
• Item 15A: Admit From (Formerly item
15)
• Item 16A: Pre-Hospital Living
Situation (Formerly item 16)
• Item 44D: Patient’s Discharge
Destination/Living Setting (Formerly
item 44A)
To minimize possible confusion due
to the use of different sets of status
codes on the IRF–PAI and the CMS–
PO 00000
Frm 00037
Fmt 4701
Sfmt 4700
1450 (also referred to as the UB–04)
claim form, we believe that the IRF–PAI
status codes should be updated to
mirror those used on the UB–04 claim
form. We also believed this update
would help with consistency, ultimately
decreasing the rate of coding submission
errors on the UB–04 claim form. We
believed that would provide response
options that mirror other commonly
used instruments in the Medicare
context allowing providers to use only
one common set of response codes. We
proposed to amend the response options
for the three items listed above to:
• 01—Home (private home/apt., board/
care, assisted living, group home)
• 02—Short-term General Hospital
• 03—Skilled Nursing Facility (SNF)
• 50—Hospice
• 62—Another Inpatient Rehabilitation
Facility
• 63—Long-Term Care Hospital (LTCH)
• 64—Medicaid Nursing Facility
• 65—Inpatient Psychiatric Facility
• 66—Critical Access Hospital
• 99—Not Listed
We also proposed to update the
options for responding to item 20B:
Secondary Source. While not expressly
stated in the preamble, but evident from
E:\FR\FM\06AUR2.SGM
06AUR2
47896
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
the web-posted draft of the IRF–PAI that
was cross-referenced in the proposed
rule, we also proposed to amend the
response codes for 20A: Primary Source
as well. As we noted in the proposed
rule, we find that the current response
options for these data elements result in
the collection of patient information
that we do not currently need to operate
the IRF PPS and the IRF quality
programs. Therefore, we limit our data
collections to those which are currently
needed, and in an effort to decrease
burden on IRFs through the
implementation of simplified response
options, we proposed to limit the
secondary source response options to
the following:
• 02—Medicare—Fee for Service
• 51—Medicare—Medicare Advantage
• 99—Not Listed
tkelley on DSK3SPTVN1PROD with RULES2
B. Additions
Further, we proposed to add (or
expand) the following items to the IRF–
PAI:
• Item 25A: Height
• Item 26A: Weight
• Item 24: Comorbid Conditions (15
additional spaces)
• Item 44C: Was the patient discharged
alive?
• Signature of Persons Completing the
IRF–PAI
Items 25A: Height and 26A: Weight,
are important items to collect for using
in the classification of facilities for
payment under the IRF–PPS as well as
for the risk adjustment of quality
measures (as described in section XIV of
this final rule). In the regulations at
section 412.29(b)(2), we specify a list of
comorbid conditions that, if certain
conditions are met, may qualify a
patient for inclusion in an IRF’s 60
percent rule compliance percentage. For
example, a patient with a lowerextremity joint replacement comorbidity
could qualify as an IRF patient under
the 60 percent rule compliance
percentage if they have one or more of
the following:
• A bilateral joint replacement
• Is over the age of 85
• Has a BMI greater than 50.
The patient’s BMI is calculated using
height and weight. By adding a patient’s
height and weight information to the
IRF–PAI, we will for the first time have
enough information on the number and
types of patients being treated for a
lower-extremity joint replacement with
a BMI greater than 50 for purposes of
analyzing the effects of the 60 percent
rule.
We also proposed to add 15
additional spaces for providers to
document patients’ comorbid medical
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
conditions at item 24: Comorbid
Conditions (located in the medical
information section of the IRF–PAI).
The IRF–PAI currently has ten spaces
available for providers to enter ICD
codes for comorbid conditions.
Including the 15 additional proposed
spaces for this item will give providers
a total of 25 spaces on the IRF–PAI.
Such expansion will enable IRFs to code
with greater specificity which may
result in accounting for additional
comorbidities. Further identification of
patient characteristics may assist in care
planning, payment assignment, and
presumptive compliance method
compliance calculations. Furthermore,
in order to stay aligned, we believe that
the number of data elements allowed on
the IRF–PAI for item 24: Comorbid
Conditions, should mirror the number
of spaces currently available for
providers to document patients’
comorbidities on the UB–04 claim.
Additionally, the ICD–10 coding scheme
will become effective on October 1,
2014, and is much more specific than
the current ICD–9 coding. Therefore,
when the agency moves from ICD–9 to
ICD–10 coding, providers may need the
additional spaces to code because of the
greater specificity under ICD–10.
Furthermore, we proposed to add a
new item 44C: ‘‘Was the patient
discharged alive?’’ to the discharge
information section on the IRF–PAI.
Adding this item as a standalone item
would allow facilities that reply ‘‘no’’ to
44C to skip items 44D, 44E, and 45,
which describe a living patient’s
discharge destination. This will also
reduce the burden on the time it takes
providers to complete the IRF–PAI.
Facilities that respond ‘‘yes’’ to item
44C will complete items 44D, 44E and
45 as they apply to the patient. We
believe that adding this question as a
standalone item would provide greater
clarity for providers when documenting
patient information on the IRF–PAI.
We also proposed to add a page to the
IRF–PAI dedicated as the signature page
for persons completing the IRF–PAI. As
of the effective date of the IRF Coverage
Requirements (see the August 7, 2009
FY 2010 IRF PPS final rule (74 FR
39762)) a patient’s IRF–PAI must be
maintained in their medical record at
the IRF (electronic or paper format), and
the information in the IRF–PAI must
correspond with all of the information
provided in the patient’s IRF medical
record. We received multiple public
comments on the FY 2010 IRF PPS
proposed rule regarding the requirement
to include the IRF–PAI in the medical
record. Commenters questioned whether
IRFs would need to adhere to the
conditions of participation in
PO 00000
Frm 00038
Fmt 4701
Sfmt 4700
§ 482.24(c)(1) that require all patient
medical record entries must be legible,
complete, dated, timed, and
authenticated in written or electronic
form by the person responsible for
providing or evaluating the service
provided, consistent with hospital
policies and procedures. When we
responded (at https://cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
InpatientRehabFacPPS/Downloads/IRFTraining-call_version_1.pdf) that IRFs
would need to adhere to § 482.24(c)(1),
providers responded by asking for a
place on the IRF–PAI where they would
be able to document the required
authentication. The addition of a
signature page for persons completing
the IRF–PAI would fulfill providers’
request to have an organized way to
document who in the IRF has completed
an IRF–PAI item and/or section when
the information was completed. We also
believe that the addition of a signature
page for those completing the IRF–PAI
will ensure that providers are satisfying
both the IRF coverage requirements and
the conditions of participation
requirements.
C. Deletions
We proposed to delete the following
items from the IRF–PAI:
• Item 18: Pre-Hospital Vocational
Category
• Item 19: Pre-Hospital Vocational
Effort
• Item 25: Is patient comatose at
admission?
• Item 26: Is patient delirious at
admission?
• Item 28: Clinical signs of dehydration
Because we no longer believe that
these items are necessary and in the
interest of reducing burden on
providers, we would like to delete them.
Items 18: Pre-Hospital Vocational
Category and 19: Pre-Hospital
Vocational Effort (currently located in
the admission identification section on
the IRF–PAI) are not used for payment
or quality purposes. While these items
will be removed from the IRF–PAI, we
note that these data elements could be
significant in a treatment context. For
example, we believe that these data
elements could be relevant during the
care planning/discharge process, as well
as during interdisciplinary team
meetings. Therefore, we would expect
them to appear in the patient’s medical
record.
We also note, that items 25: Is patient
comatose at admission, 26: Is patient
delirious at admission, and 28: Clinical
signs of dehydration (currently located
in the medical information section on
the IRF–PAI) are voluntary items that
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
are not used for our payment or quality
program purposes. Therefore, we do not
believe it is necessary to collect this
information on the IRF–PAI.
Furthermore, to the extent such
information would be relevant to the
provision of patient care; this
information should be captured in
either the transfer documentation from
the referring physician, or the patients’
initial assessment documentation. As
such, continuing to require this
information on the IRF–PAI would be
duplicative since the items should be
well documented in the patients’
medical record from their stay at the
facility.
tkelley on DSK3SPTVN1PROD with RULES2
D. Changes
We proposed to replace all references
to the ICD–9–CM code(s) in the IRF–PAI
with references to ICD code(s). This
change would allow CMS to forgo
making additional changes to the IRF–
PAI when the adopted ICD code(s)
change.
Proposed Technical Correction
We proposed technical corrections at
items 44D, 44E and 45 to conform to the
additions above. We believe that adding
language to these items indicating that
the question can be skipped depending
upon how item 44C is answered, will
help reduce submission errors for
providers when filling out the IRF–PAI.
A draft of the IRF–PAI, with the
revisions proposed in the proposed rule
was made available for download on the
IRF PPS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
InpatientRehabFacPPS/IRFPAI.html.
We received 18 comments on the
proposed changes to the non-quality
related revisions to IRF–PAI sections,
which are summarized below.
Comment: Overall, the majority of
commenters commended CMS for
assessing the non-quality related
portions of the IRF–PAI for refinements.
Response: We appreciate the support
from the commenters regarding the
changes to the IRF–PAI. We believe that
the IRF–PAI changes will promote
efficiency and clarity for providers as
well as ensure that our policies reflect
the current data needs required to
support the IRF PPS program.
Comment: Many of the commenters
supported our proposal to align the
status codes on the IRF–PAI with those
used on the UB–04 claim form.
Commenters agreed that the proposed
changes would help providers avoid
coding errors. More specifically, two
commenters commended our proposed
removal of the status code 13 (sub-acute
care) stating that the term is not clearly
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
defined and is more commonly used as
a marketing term.
Response: We appreciate the support
from commenters regarding the
proposed changes to the IRF–PAI. We
believe that streamlining claim
submission codes and IRF–PAI status
codes will ease the administrative
burden for providers as well as reduce
coding errors.
Comment: One commenter suggested
that we should delete item 44E: Was
patient discharged with Home Health
Services, and instead add code 06-Home
under care of organized home health
service organization, to item 44D:
Patient’s discharge destination/living
setting. Likewise, another commenter
recommended that we remove the
proposed new item 44C: Was the patient
discharged alive and add the status code
option 20-Expired. Additionally,
another commenter supported our
proposal to add 50-Hospice as a status
code option, however, suggested that
CMS should add the status code option
51-Hospice (Institutional Facility). The
commenters suggested that these status
code options would more accurately
reflect the UB–04 claim form.
Response: As we mentioned in the
proposed rule, many of the changes we
made on the non-quality related IRF–
PAI items were to initiate
standardization between IRF claims and
the IRF–PAI when coding patients. Our
intent in mirroring the IRF–PAI status
codes with the UB–04 claim form codes
was to help providers avoid future
coding errors. After reviewing the
comments submitted, we agree with
most of the commenters suggestions to
add several status code options to
further mirror the UB–04 claim form. In
addition to finalizing the proposed
status code changes, we will also add
the following status code options, which
are identical to the options on the UB–
04 claim form to items 15A: Admit
From; 16A: Pre-hospital Living Setting;
and 44D: Patient’s discharge
destination/living setting:
04—Intermediate Care Facility
06—Home under care of organized
home health service organization
51—Hospice (Institutional Facility)
61—Within institution to swing bed
We do not agree with the commenters
suggestion to remove item 44C: Was the
patient discharged alive, and add 20Expired as a status code option.
Although the status code would mirror
the UB–04 claim form, we do not
believe ‘‘expired’’ is an adequate
response when providers are answering
a question regarding the patient’s
discharge destination. If a patient
expires while in the IRF, they are not
PO 00000
Frm 00039
Fmt 4701
Sfmt 4700
47897
discharged from the facility therefore,
we would still need item 44C: Was the
patient discharged alive. Additionally,
adding this item as a standalone item
allows clear delineation of a section of
the IRF–PAI that providers would not
have to report if the reply to 44C is
‘‘no’’. Items 44D and 45, which describe
a living patient’s discharge destination,
can then be skipped. Finally, in light of
the addition of status code option 06—
Home under care of organized home
health service organization; we will
remove item 44E: Was patient
discharged with Home Health Services
live, as this item would be redundant
for providers to answer.
Comment: One commenter suggested
that we should consider creating a new
status code option 08-subacute (SNF
with continued therapy plan of care/
skilled needs).
Response: We appreciate the
commenter’s suggestion and will
consider creating a new status code
option 08-Subacute (SNF with
continued therapy plan of care/skilled
needs) during future rulemaking.
However, our intentions of changing the
status code options on the IRF–PAI were
to mirror those on the UB–04 claim
form, and this suggestion does not
conform to those changes as it is not
currently necessary for IRF payment or
quality reporting.
Comment: Several commenters
expressed concern that the coding
changes to the IRF–PAI for items 15A:
Admitted From; 16A: Pre-Hospital
Living Situation; and 44D: Patient’s
Discharge Destination, are not optimal
and suggested that we retain the current
IRF–PAI coding options for these items.
The commenters stated that the data
collected by IRFs in response to these
items provide valuable information for
quality review and operational
management. Limiting the response
options too severely, the commenters
indicated, would impair an IRF’s ability
to collect and retain valuable
information for payers other than
Medicare.
Response: We appreciate the
commenters suggestion as we continue
to believe that the status code changes
are necessary to provide better clarity
and alignment with the UB–04 claim
form, ultimately reducing coding
submission errors. Although we have
removed some status code options, we
do not believe that we are preventing or
deterring IRFs from continuing to
collect patient information and
document it within the medical record.
Comment: One commenter disagreed
with our proposal to group the existing
status codes for private home, board/
care, assisted living and group home
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47898
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
together under the proposed status code
01—Home (private home/apt., board/
care, assisted living, group home) and to
completely remove the code options for
transitional living and intermediate care
from items 15A: Admitted From; 16A:
Pre-Hospital Living Situation; and 44D:
Patient’s Discharge Destination. The
commenter recommended that if the
proposed status code changes are
finalized, we should consider adding
transitional living and intermediate care
under the status code 01—Home.
Response: As we have previously
mentioned, our goal in proposing to
change some of the status code options
on the IRF–PAI is to be as consistent as
possible with the UB–04 claim form.
Therefore, we disagree with the
commenters’ suggestion to ungroup the
existing status codes for private home,
board/care, assisted living, and group
home under the proposed status code
01—Home. But we do agree with the
commenter that intermediate care and
transitional living are status code
options that should be included in the
IRF–PAI. Therefore, we will add status
code 04—Intermediate care.
Furthermore, we will include
transitional living as one of the
locations listed in status code 01—
Home to the response options.
Comment: Several commenters
expressed concerns with our proposed
change to limit the status code options
in item 22B: Secondary Source, to only
02—Medicare-Fee For Service; 51
Medicare-Medicare Advantage; and 99
Not Listed, stating that IRFs would lose
the ability to track other payer sources
beyond Medicare. One commenter
suggested that if we remove the majority
of the code options in item 20B:
Secondary Source, then we should
display the current comprehensive list
of payment sources under item 20A:
Primary Source. Additionally, the
commenter recommended that we add
Medicaid Expansion and the Health
Insurance Marketplace as status code
options. Another commenter stated that
decreasing the number of code options
will not really save time and burden for
providers.
Response: We respectfully disagree
with the commenters and continue to
believe that decreasing the number of
code options will allow providers to
code more accurately and reduce
burden. However, even if this is not the
case, we do not have authority to collect
the various information requests the
commenters suggested since the
information is not currently relevant for
administration of the IRF PPS or for the
IRF Quality Reporting Program.
According to the Privacy Act at 5 U.S.C.
552a(e)(1), an ‘‘agency that maintains a
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
system of records shall—(1) maintain in
its records only such information about
an individual as is relevant and
necessary to accomplish a purpose of
the agency required to be accomplished
by statute or executive order of the
President.’’ When an IRF uploads the
IRF–PAI data, it is entered into CMS’s
Privacy Act System of Records. As the
status code options removed from the
secondary source item are currently
irrelevant to both the IRF payment
system and the IRF Quality Reporting
Program, we do not have statutory
authority to continue to collect this
information. Furthermore, we do not
believe that we are limiting IRFs from
continuing to collect and document
payer source information by way of
their own internal mechanisms.
Furthermore, as we previously
mentioned, it was our intent to include
item 20A: Primary Source regarding this
update, as the list of status code options
identified in the Payer Information
section relates to both items 20A and
20B. Additionally, the draft version of
the IRF–PAI that went on display with
the proposed rule very clearly depicts
the changes; therefore, we will finalize
our proposals as they were described in
the proposed rule and the draft IRF–PAI
Comment: The majority of
commenters supported the additional 15
extra spaces in item 24: Comorbid
Conditions, and the new items 25A:
Height and 26A Weight. One commenter
suggested that items 25A and 26A
would be more beneficial if time
parameters such as ‘‘admission’’ or
‘‘discharge’’ were placed on the
measure. One commenter suggested that
adding items 25A: Height; 26A Weight;
and 27: Swallowing Status, to the IRF–
PAI would be redundant, as this
information is already in the patient’s
medical record. This commenter also
requested clarification as to whether
these items would be mandatory or
optional requirements on the IRF–PAI.
Response: We appreciate the support
from the commenters regarding the
proposed addition of the 15 extra spaces
in item 24: Comorbid Conditions, and
the new items 25A: Height and 26A
Weight. We believe these items are
pertinent information to add to the IRF–
PAI and allow additional information to
be collected after the transition to the
more specific ICD–10–CM codes. We
note that the proposed items 25A:
Height and 26A: Weight already
indicate ‘‘on admission’’ as a time
parameter. Additionally, items 25A:
Height and 26A: Weight will be
mandatory items on the IRF–PAI, as
these items are needed for payment and
quality measurement purposes. CMS
did not propose any changes to item 27:
PO 00000
Frm 00040
Fmt 4701
Sfmt 4700
Swallowing Status, therefore, it will
remain a voluntary item.
We disagree with the commenter’s
statement that items 25A and 26A are
redundant, as all of the information on
the IRF–PAI must also be included in
some form in the medical record. We
require this information on the IRF–PAI
so that it may be submitted to us to
enable the implementation of the IRF
PPS and the IRF quality reporting
program. Therefore, we are finalizing
both of these items as they were
proposed.
Comment: The majority of
commenters supported the addition of a
signature page to the IRF–PAI. A few
commenters suggested that we allow an
electronic signature to satisfy this new
requirement. One commenter suggested
that we add a prompt on the signature
page for ‘‘time’’ in order to comply with
the requirements at 482.24(c)(1).
Response: We appreciate the
commenters’ suggestions regarding the
proposed signature page in the IRF–PAI.
In order to stay consistent with our
current procedures, providers should
reference the clarification to our
coverage requirements regarding the use
of electronic signatures located at
(https://cms.gov/Medicare/Medicare-Feefor-Service-Payment/InpatientRehabFac
PPS/Downloads/ElecSysClar.pdf).
Should a formal policy be established
for the development of Medicare’s
formal electronic signature policies, we
may need to revise or further clarify
these criteria to ensure that it is in
accordance with those policies.
Additionally, we agree with the
commenters’ suggestion that a ‘‘time’’
prompt should be added to the signature
page. Therefore, we will add an
additional column for providers to
indicate the time that they completed an
item and/or section of the IRF–PAI.
Comment: A few commenters
requested that we clarify and/or provide
more specific instructions for
completing the proposed signature page
in the IRF–PAI. One commenter was
unclear as to why multiple signatures
are required, as the information on the
IRF–PAI is documented and
authenticated within the medical record
documentation. Another commenter
requested clarification regarding the use
of the word ‘‘submit’’ when referring to
the sentence, ‘‘I also certify that I am
authorized to submit this information by
this facility on its behalf.’’ The
commenter acknowledged that anyone
who contributes to the IRF–PAI is, in
effect, involved in the submitting of data
to us. However, in common parlance,
‘‘submit’’ often refers to the actual act of
electronically submitting the final
product to us.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
Response: We plan to provide more
specific instructions for completing the
signature page in the IRF–PAI training
manual that will accompany the revised
IRF–PAI form. We understand the
commenter’s concerns regarding the
attestation statement on the signature
page, and we are deleting the statement,
‘‘I also certify that I am authorized to
submit this information by this facility
on its behalf.’’ Removal of this statement
from the attestation should clarify what
providers are attesting to, and alleviate
any concerns.
Comment: Several commenters
expressed concern that the proposed
addition of the signature page is
burdensome and unnecessary because
staff entries in the electronic health
record are already stamped with date
and time, in addition to the name and
credentials of the person entering the
information. These commenters stated
that it would be burdensome to track
down individuals to sign an additional
sheet of paper.
Response: When the coverage
requirements became effective January
1, 2010, providers requested a place on
the IRF–PAI where they could sign,
date, and record the time in order to
comply with the hospital conditions of
participation (CoPs). We are taking this
opportunity to acknowledge those
requests made by the industry.
Additionally, the signature item clarifies
for the provider and CMS that the
requirement has been met.
Comment: One commenter requested
that we provide a definition for the new
discharge status code 64—Medicaid
Nursing Facility.
Response: Medicaid coverage of
nursing facility services is available
only for services provided in a nursing
home licensed and certified by the state
survey agency as a Medicaid Nursing
Facility (NF). Medicaid nursing facility
services are available only when other
payment options are unavailable and
the individual is eligible for the
Medicaid program. For more
information please reference the link
provided: https://www.medicaid.gov/
Medicaid-CHIP-Program-Information/
By-Topics/Delivery-Systems/
Institutional-Care/Nursing-FacilitiesNF.html.
Comment: One commenter
recommended that the IRF–PAI changes
be delayed one year to coincide with the
implementation of ICD–10, so that
providers can incorporate all of the
changes at one time. This commenter
suggested that a delayed effective date
for the IRF–PAI changes would decrease
burden by only having to make updates
to information systems once.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
Response: We proposed an effective
date of October 1, 2014, for all of the
finalized IRF–PAI changes. In concert
with stakeholder recommendations, we
are finalizing this proposal which will
help alleviate burden on providers. We
believe that the October 1, 2014
effective date will provide IRF’s with an
adequate amount of time to make
necessary changes to information
systems as well as provide extensive
education for clinicians.
Final Decision: Based on careful
consideration of the comments that we
received on the proposed non-quality
related updates to the IRF–PAI for FY
2014, we are finalizing the following
items:
• The status code options for Items
15A: Admit From, 16A: Pre-hospital
Living Situation and 44D: Patient’s
Discharge Destination/Living Setting
will be 01—Home (private home/apt.,
board/care, assisted living, group home,
transitional living); 02—Short-term
General Hospital; 03—Skilled Nursing
Facility (SNF); 04—Intermediate Care;
06—Home under care of organized
home health service organization; 50—
Hospice (Home); 51—Hospice
(Institutional Facility); 61—Within
institution to swing bed; 62—Another
Inpatient Rehabilitation Facility; 63—
Long-Term Care Hospital (LTCH); 64—
Medicaid Nursing Facility; 65—
Inpatient Psychiatric Facility; 66—
Critical Access Hospital; 99—Not Listed
• The status code options for Items
20A: Primary Source and 20B:
Secondary Source will be 02—
Medicare-Fee for Service; 51—
Medicare-Medicare Advantage; 99—Not
Listed
• The additions will include Item 24:
Comorbid Conditions (15 additional
spaces); item 25A: Height; item 26A:
Weight; Signature of Persons
Completing the IRF–PAI (with the
addition of a ‘‘time’’ prompt); 44C: Was
the patient discharged alive?
• The deletions will include items 18:
Pre-Hospital Vocational Category; 19:
Pre-Hospital Vocational Effort; 25: Is the
patient comatose at admission; 26: Is the
patient delirious at admission; 28:
Clinical signs of dehydration; 44E: Was
patient discharged with Home Health
Services
• Using the language ICD code(s) on
the IRF–PAI
• The technical corrections at items
44D: Patient’s discharge destination/
living setting and 45: Discharge to
Living With
• The revised IRF–PAI will become
effective for IRF discharges occurring on
or after October 1, 2014. All final
changes to the IRF–PAI will be
PO 00000
Frm 00041
Fmt 4701
Sfmt 4700
47899
represented when it is posted with the
final rule.
X. Technical Corrections to the
Regulations at § 412.130
In the FY 2012 IRF PPS final rule (76
FR 47869 through 47873), we revised
the regulations for inpatient
rehabilitation facilities at § 412.23(b),
§ 412.25(b), § 412.29, and § 412.30 to
update and simplify the policies, to
eliminate unnecessary repetition and
confusion, and to enhance consistency
with the IRF coverage requirements.
Among other revisions, we removed the
regulations that were formerly in
§ 412.30, and revised and consolidated
the requirements regarding ‘‘new’’ IRFs
and ‘‘new’’ IRF beds that previously
existed in § 412.30 into the revised
regulations at § 412.29(c). However, we
have recently discovered that § 412.130,
which outlines the policies regarding
retroactive adjustments for incorrectly
excluded hospitals and units, was not
updated to reflect the changes to
§ 412.30 and § 412.29. Specifically,
§ 412.130 still references regulations in
§ 412.30 that were revised and
consolidated into § 412.29(c). Further, it
still references regulations that were
formerly in § 412.23(b)(2), but were
moved into § 412.29(b) in the FY 2012
IRF PPS final rule (76 FR 47869 through
47873).
We proposed to make the following
technical corrections to the regulations
in § 412.130 to conform with the
revisions to the regulations in
§ 412.23(b), § 412.29, and § 412.30 that
were implemented in the FY 2012 IRF
PPS final rule (76 FR 47869 through
47873):
• Replace the current reference to
‘‘§ 412.23(b)(8)’’ in § 412.130(a)(1) with
the new reference to § 412.29(c),
• Replace all of the current references
to ‘‘§ 412.23(b)(2)’’ in § 412.130(a)(1),
(2), and (3) with the new reference to
§ 412.29(b),
• Replace the current reference to
‘‘§ 412.30(a)’’ in § 412.130(a)(2) with the
new reference to § 412.29(c), and
• Replace the current reference to
‘‘§ 412.30(c)’’ in § 412.130(a)(3) with the
new reference to § 412.29(c).
We did not receive any comments on
the proposed technical corrections to
the regulations at § 412.130. Thus, we
are finalizing the technical corrections
as proposed, effective for IRF discharges
occurring on or after October 1, 2013.
XI. Revisions to the Conditions of
Payment for IRF Units Under the IRF
PPS
The regulations at § 412.25 specify the
requirements for an IRF unit to be
excluded from the inpatient prospective
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47900
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
payment system (IPPS) specified in
§ 412.1(a)(1) and to instead be paid
under the IRF PPS specified in
§ 412.1(a)(3). The requirements at
§ 412.25 are unique to IRF units of
hospitals, whereas the requirements at
§ 412.29 apply to both freestanding IRF
hospitals and IRF units of hospitals.
Among the requirements at § 412.25 is
the requirement (at § 412.25(a)(1)(iii))
that the institution of which the IRF
unit is a part must have ‘‘enough beds
that are not excluded from the
prospective payment systems to permit
the provision of adequate cost
information, as required by § 413.24(c)
of this chapter.’’ We have not previously
specified how many such beds the
hospital, of which the IRF unit is a part,
must have to meet this requirement.
However, we have recently received
questions from providers about whether
one or two hospital beds that are
certified for payment under the IPPS, in
some cases beds that are rarely used for
patient care, would meet the
requirement at § 412.25(a)(1)(iii). We
believe this does not meet the
requirement at § 412.25(a)(1)(iii), which
provides for the hospital of which the
IRF unit is a part to be an IPPS hospital,
which we believe is not demonstrated
by the presence of just one or two
hospital beds.
In addition, from a fairness and
quality of care perspective, we are
particularly concerned about the
application of the regulations in
§ 412.29(g), which require freestanding
IRF hospitals to have a full-time director
of rehabilitation, but only require IRF
units of acute care hospitals (and CAHs)
to have a director of rehabilitation for 20
hours per week. We believe that it is
unfair to other freestanding IRF
hospitals and potentially problematic
from a quality of care standpoint for an
IRF that is effectively operating as a
freestanding IRF hospital, even though
it is technically classified as an IRF unit,
to be allowed to have a director of
rehabilitation only 20 hours per week.
Further, we are unclear how the IRF
unit that is part of a hospital with only
one or two beds would be able to meet
another requirement, at § 412.25(a)(7),
that specifies that an IRF unit must have
beds that are ‘‘physically separate from
(that is, not commingled with) the
hospital’s other beds.’’ The requirement
at § 412.25(a)(7) means that there is
some sort of physical separation that
distinguishes the IRF unit from the rest
of the hospital beds. We believe that it
is unlikely that this requirement would
be met in the situation in which the
hospital of which the IRF unit is a part
only has one or two beds, in some cases
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
beds that are rarely used for patient
care.
Thus, we proposed to specify at
§ 412.25(a)(1)(iii) a minimum number of
hospital beds that the IPPS hospital
must have to meet the requirements at
§ 412.25(a)(1)(iii) for having an IRF unit.
We note that, though§ 412.25(a)(1)(iii)
also applies to inpatient psychiatric
facilities (IPFs), these facilities have
their own requirements at § 412.27 for
payment under the IPF PPS that we are
not changing in this proposed rule. IPFs
should continue following the
regulations at § 412.27.
We proposed to specify in
§ 412.25(a)(1)(iii) that the institution of
which the IRF unit is a part must have
at least 10 staffed and maintained
hospital beds that are not excluded from
the IPPS, or at least 1 staffed and
maintained hospital bed for every 10
certified IRF beds, whichever number is
greater. If the institution is not able to
meet this requirement, then the IRF unit
should instead be classified as an IRF
hospital. We also proposed to exclude
CAHs that have IRF units from these
requirements, as CAHs already have
very specific bed size restrictions.
We received 3 comments on the
proposed revisions to the conditions of
payment for IRF units under the IRF
PPS, which are summarized below.
Comment: Several commenters noted
that the conversion from an IRF unit to
a freestanding IRF hospital to meet the
new proposed requirements could pose
problems for a facility in meeting
certain state licensing and/or state
certificate of need requirements. These
commenters suggested that these statelevel requirements could be
‘‘burdensome, difficult and expensive’’
for the IRF.
Response: Although the conversion
from an IRF unit to a freestanding IRF
hospital is a simple administrative task
within Medicare, which does not
necessitate any new surveys, any
changes to the IRF’s Medicare provider
agreement, or any changes to the IRF’s
payment status under Medicare, we
recognize that the conversion may take
longer to complete under state laws.
Thus, we are implementing this change
on a one-year delay, so that it will be
effective for IRF discharges occurring on
or after October 1, 2014, to give IRFs
who are affected by this change ample
time to conform to state certificate of
need or other state licensure laws.
Final Decision: After considering the
comments that we received on the
proposed revision to the conditions of
payment for IRF units under the IRF
PPS, we are finalizing the change to
§ 412.25(a)(1)(iii) to specify that the
institution of which the IRF unit is a
PO 00000
Frm 00042
Fmt 4701
Sfmt 4700
part must have at least 10 staffed and
maintained hospital beds that are not
excluded from the IPPS, or at least 1
staffed and maintained hospital bed for
every 10 certified IRF beds, whichever
number is greater. We exclude CAHs
that have IRF units from these
requirements, as CAHs already have
very specific bed size restrictions. We
are implementing this change effective
for IRF discharges occurring on or after
October 1, 2014 (a one-year delay in the
effective date) to give IRFs affected by
this change adequate time to comply
with state certificate of need or other
state licensure laws.
XII. Clarification of the Regulations at
§ 412.630
In the original rule establishing a
prospective payment system for
Medicare payment of inpatient hospital
services provided by a rehabilitation
hospital or by a rehabilitation unit of a
hospital, we stated that that there would
be no administrative or judicial review,
under sections 1869 and 1878 of the Act
or otherwise, of the establishment of
case-mix groups, the methodology for
the classification of patients within
these groups, the weighting factors, the
prospective payment rates, outlier and
special payments and area wage
adjustments. See FY 2002 IRF PPS final
rule (66 FR 41316, 41319). Our intent
was to honor the full breadth of the
preclusion of administrative or judicial
review provided by section 1886(j)(8) of
the Act. However, the regulatory text
reflecting the preclusion of review has
been at times improperly interpreted to
allow review of adjustments authorized
under section 1886(j)(3)(v) of the Act.
Because we interpret the preclusion of
review at § 1886(j)(8) of the Act to apply
to all payments authorized under
section 1886(j)(3) of the Act, we do not
believe that there should be
administrative or judicial review of any
part of the prospective rate.
Accordingly, we are clarifying our
regulation at § 412.630 by deleting the
word ‘‘unadjusted’’ so that the
regulation will clearly preclude review
of ‘‘the Federal per discharge payment
rates.’’ This clarification will provide for
better conformity between the
regulation and the statutory language.
As such, in accordance with sections
1886(j)(7)(A), (B), and (C) of the Act, we
are revising the regulations at § 412.630
to clarify that administrative or judicial
review under sections 1869 or 1878 of
the Act, or otherwise, is prohibited with
regard to the establishment of the
methodology to classify a patient into
the case-mix groups and the associated
weighting factors, the federal per
discharge payment rates, additional
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
payments for outliers and special
payments, and the area wage index.
We received 2 comments on the
proposed clarification of the regulations
at § 412.630, which are summarized
below.
Comment: The commenters expressed
concerns with our proposal to revise the
regulations at 42 CFR 412.630 to clarify
that the Medicare statute precludes
administrative and judicial review of
the Federal per discharge payment rates,
including the LIP adjustment. One
commenter stated that the proposal is
not a ‘‘clarification’’ that can be applied
to pending cases, is inconsistent with
the statute, runs afoul of the
presumption of judicial review, fails to
give proper notice of the regulatory
change, and is unconstitutional.
Response: We disagree with the
commenter’s statements. Our proposed
change serves to clarify the regulation so
that it clearly reflects the preclusion of
review found in the statute. It also
removes any doubt as to the conformity
of the regulation to the preclusion of
review found in the statute, which by its
own terms is applicable to all pending
cases regardless of whether it is
reflected in regulations or not.
We also strongly disagree with the
commenter’s reading of the statute.
Section 1886(j)(8) of the statute broadly
precludes review of ‘‘the prospective
payment rates under paragraph (3),’’
that is, section 1886(j)(3). Within this
section, subsection 1886(j)(3)(A)
authorizes certain adjustments to the
IRF payment rates and, within that,
subsection 1886(j)(3)(A)(v) authorizes
adjustments to the rates by such other
factors as the Secretary determines are
necessary to properly reflect variations
in necessary costs of treatment among
rehabilitation facilities.’’ The LIP
adjustment is made under authority of
section 1886(j)(3)(A)(v). As that
provision is contained within section
1886(j)(3), and the IRF payment rates
under section 1886(j)(3) are precluded
from review by section 1886(j)(8), the
LIP adjustment falls squarely within the
statutory preclusion of review. Such
preclusion overcomes any presumption
of reviewability that might generally
apply, and it is not unconstitutional for
Congress (which has the power to define
the jurisdiction of the federal courts) to
preclude review of certain issues as it
has done here. Several virtually
identical preclusions of review in other
sections of the Medicare statute have
been repeatedly upheld and applied by
federal courts. Finally, as to notice, the
proposed rule itself served as notice of
our intention to revise the regulation. In
addition, as discussed below, the
longstanding language of the statute
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
itself provides sufficient notice to apply
the preclusion.
Comment: One commenter stated that
our proposal cannot be a clarification
because we have allowed review of
matters concerning the LIP adjustment
for many years. This commenter further
stated that any preclusion of review
should apply only to the ‘‘formulas’’
used in the IRF payment rates, and that
to preclude review would prevent
providers from correcting errors in their
payments and would result in two
separate methods being used to pay IRFs
and hospitals paid under the inpatient
prospective payment system (IPPS).
Response: We disagree with these
comments. The preclusion of review has
been effective since its enactment as
part of the IRF prospective payment
system in 2002. No regulation or
revision of any regulation was necessary
for the statutory preclusion to become
effective, regardless of whether we or
our contractors may have participated in
review of IRF LIP matters in the past
without making a jurisdictional
objection. To the extent that such
erroneous participation may have
occurred, it does not override the
mandate of the statute or prevent us
from immediately applying the statutory
preclusion of review.
In addition, the preclusion applies to
all aspects of the IRF PPS payment rates,
not just the formulas. Courts have
applied nearly identical preclusion
provisions in other parts of the
Medicare statute to prevent review of all
subsidiary aspects of the matter or
determination protected from review.
Finally, while precluding review of the
IRF LIP adjustment may prevent
correction of certain errors, we can only
conclude that Congress has made the
judgment that such a result is an
appropriate trade-off for the gains in
efficiency and finality that are achieved
by precluding review. Similarly,
although applying the preclusion here
may result in certain questions being
reviewable for an IPPS hospital but not
an IRF, this is a judgment that Congress
has made. We note that there is a
preclusion of review provision in the
IPPS statute also, at section 1886(d)(7).
The precise contours of these preclusive
provisions were for Congress to draw.
Final Decision: After careful review of
the comments we received on the
clarification of the regulations at
§ 412.630, we are adopting our proposal
to revise the regulations at 42 CFR
412.630 to clarify that the Medicare
statute precludes administrative and
judicial review of the Federal per
discharge payment rates under section
1886(j)(3), including the LIP adjustment.
PO 00000
Frm 00043
Fmt 4701
Sfmt 4700
47901
This revision to the regulation is
effective October 1, 2013.
XIII. Revision to the Regulations at
§ 412.29
According to the regulations at
§ 412.29(d), to be excluded from the
inpatient prospective payment system
(IPPS) and instead be paid under the
IRF PPS, a facility must ‘‘have in effect
a preadmission screening procedure
under which each prospective patient’s
condition and medical history are
reviewed to determine whether the
patient is likely to benefit significantly
from an intensive inpatient hospital
program. This procedure must ensure
that the preadmission screening is
reviewed and approved by a
rehabilitation physician prior to the
patient’s admission to the IRF.’’ The
latter sentence of this regulation is
based on the preadmission screening
requirement for Medicare coverage of
IRF services in § 412.622(a)(4)(i)(D). The
requirement was repeated in both places
for consistency.
However, in § 412.622(a)(4)(i)(D), we
specify that this requirement applies to
patients ‘‘for whom the IRF seeks
payment’’ from Medicare. We believe
that the analogous requirement in
§ 412.29(d) should also clearly state that
it applies only to patients for whom the
IRF is seeking payment directly from
Medicare. Other payer sources, such as
private insurance, have their own IRF
admission requirements, and we do not
believe that it would be appropriate to
interfere with or duplicate the
requirements that other payer sources
may already have in place. Thus, we
proposed to amend § 412.29(d) to clarify
that the IRF’s preadmission screening
procedure must ensure that the
preadmission screening for a Medicare
Part A Fee-for-Service patient is
reviewed and approved by a
rehabilitation physician prior to the
patient’s admission to the IRF. We
continue to believe that the basic
preadmission screening procedure itself
is an important element of providing
quality IRF care to all patients and, thus,
we will require that the basic
preadmission screening procedure
requirement remain in place for all
patients regardless.
We received 5 comments on the
revision to the regulations at
§ 412.29(d), which are summarized
below.
Comment: Several commenters
expressed support for the proposed
revisions to the regulations at § 412.29,
which clarify that we require
rehabilitation physician review and
concurrence of a patient’s preadmission
screening prior to the IRF admission
E:\FR\FM\06AUR2.SGM
06AUR2
47902
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
only for Medicare Fee-for-Service
beneficiaries. The commenters indicated
that this proposed regulation change
would greatly relieve the burden on
IRFs that treat a large proportion of nonMedicare patients, for whom other
admission requirements typically apply.
These commenters also requested that
we amend the Rehabilitation Unit and
Rehabilitation Hospital Criteria
Worksheets and the Attestation
Statement (State Operations Manual
Exhibit 127, Attestation Statement) to
appropriately reflect this change to the
regulations.
Response: We appreciate the
stakeholder community bringing this
issue to our attention, thereby giving us
the opportunity to alleviate unintended
provider burden. We encourage
stakeholders to bring these types of
issues to our attention, as we are always
willing to consider suggestions that can
improve the Medicare program while at
the same time reducing the regulatory
burden on providers. We will ensure
that the appropriate adjustments are
made to the Worksheets and the
Attestation Statement in accordance
with the change to the regulations.
Comment: One commenter
recommended that we further clarify the
distinction between Medicare
Conditions of Payment and the IRF
coverage requirements. The commenter
suggested that a table distinguishing the
two requirements would be useful to
providers.
Response: We thank the commenter
for the suggestion, and will take this
into consideration for future stakeholder
outreach in this area.
Final Decision: Based on
consideration of the comments received
on the proposed change to § 412.29(d),
we are finalizing this change, effective
for IRF discharges occurring on or after
October 1, 2013.
XIV. Revisions and Updates to the
Quality Reporting Program for IRFs
tkelley on DSK3SPTVN1PROD with RULES2
A. Background and Statutory Authority
Section 3004(b) of the Affordable Care
Act added section 1886(j)(7) to the Act,
which requires the Secretary to
implement a quality reporting program
(QRP) for IRFs. This program applies to
freestanding IRF hospitals as well as IRF
units that are affiliated with acute care
facilities, which includes critical access
hospitals (CAHs).
Beginning in FY 2014, section
1886(j)(7)(A)(i) of the Act requires the
reduction of the applicable IRF PPS
annual increase factor, as previously
modified under section 1886(j)(3)(D) of
the Act, by 2 percentage points for any
IRFs that fail to submit data to the
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
Secretary in accordance with
requirements established by the
Secretary for that fiscal year. Section
1886(j)(7)(A)(ii) of the Act notes that
this reduction may result in the increase
factor being less than 0.0 for a fiscal
year, and in payment rates under this
subsection for a fiscal year being less
than the payment rates for the preceding
fiscal year. Any reduction based on
failure to comply with the reporting
requirements is, in accordance with
section 1886(j)(7)(B) of the Act, limited
to the particular fiscal year involved.
The reductions are not to be cumulative
and will not be taken into account in
computing the payment amount under
section (j) for a subsequent fiscal year.
Section 1886(j)(7)(C) of the Act
requires that each IRF submit data to the
Secretary on quality measures specified
by the Secretary. The required quality
measure data must be submitted to the
Secretary in a form, manner and time,
specified by the Secretary.
The Secretary is generally required to
specify measures that have been
endorsed by the entity with a contract
under section 1890(a) of the Act. This
contract is currently held by the
National Quality Forum (NQF), which is
a voluntary consensus standard-setting
organization. The NQF was established
to standardize health care quality
measurement and reporting through its
consensus development process.
We have generally adopted NQFendorsed measures in our reporting
programs. However, section
1886(j)(7)(D)(ii) of the Act provides that
‘‘in the case of a specified area or
medical topic determined appropriate
by the Secretary for which a feasible and
practical measure has not been endorsed
by the entity with a contract under
section 1890(a) of the Act, the Secretary
may specify a measure that is not so
endorsed, so long as due consideration
is given to measures that have been
endorsed or adopted by a consensusbased organization identified by the
Secretary.’’ Under section
1886(j)(7)(D)(iii) of the Act, the
Secretary was required to publish the
selected measures that will be
applicable to the FY 2014 IRF PPS no
later than October 1, 2012.
Section 1886(j)(7)(E) of the Act
requires the Secretary to establish
procedures for making data submitted
under the IRF QRP available to the
public. The Secretary must ensure that
each IRF is given the opportunity to
review the data that is to be made public
prior to the publication or posting of
this data.
We seek to promote higher quality
and more efficient health care for all
patients who receive care in acute and
PO 00000
Frm 00044
Fmt 4701
Sfmt 4700
post-acute care settings. Our efforts are,
in part, effectuated by quality reporting
programs coupled with the public
reporting of data collected under those
programs. The initial framework of the
IRF QRP was established in the FY 2012
IRF PPS final rule (76 FR 47873).
B. Quality Measures Previously
Finalized for and Currently Used in the
IRF Quality Reporting Program
1. Measures Finalized in the FY 2012
IRF PPS Final Rule
In the FY 2012 IRF PPS final rule (76
FR 47874 through 47878), we adopted
applications of 2 quality measures for
use in the first data reporting cycle of
the IRF QRP: (1) An application of
‘‘Catheter-Associated Urinary Tract
Infection [CAUTI] for Intensive Care
Unit Patients’’ 1 (NQF#0138); and (2) an
application of ‘‘Percent of Residents
with Pressure Ulcers that Are New or
Worsened (short-stay)’’ (NQF #0678).
We adopted applications of these 2
measures because neither of them, at the
time, was endorsed by the NQF for the
IRF setting. We also discussed our plans
to propose a 30-Day All Cause Risk
Standardized Post IRF Discharge
Hospital Readmission Measure at a later
date.
2. Measures Finalized in the CY 2013
OPPS/ASC Final Rule
In the CY 2013 OPPS/ASC final rule
(77 FR 68500 through 68507), we
adopted:
• Updates to the CAUTI measure to
reflect the NQF’s expansion of this
measure to the IRF setting, replacing our
previous adoption of an application of
the measure for the IRF QRP;
• A policy that would allow any
measure adopted for use in the IRF QRP
to remain in effect until the measure
was actively removed, suspended, or
replaced (and specifically applied this
policy to the CAUTI and pressure ulcer
measures that had already been adopted
for use in the IRF QRP); and
• A sub-regulatory process to
incorporate NQF updates to IRF quality
1 The version of the CAUTI measure that was
adopted in the FY 2012 IRF PPS final rule (76 FR
47874 through 47876) was titled ‘‘CatheterAssociated Urinary Tract Infection [CAUTI] Rate
Per 1,000 Urinary Catheter Days for ICU patients.
However, shortly after the FY 2012 IRF PPS final
rule was published, this measure was submitted by
the CDC (measure steward) to the NQF for a
measure maintenance review, The CDC asked for
changes to the measure, including expansion of the
scope of the measure to non-ICU patient care
locations and additional healthcare facility settings,
including IRFs. The name of the measure was
changed to reflect the character of the revised
CAUTI measure. This measure is now titled
‘‘National Health Safety Network (NHSN) Catheter
Associated Urinary Tract Infection (CAUTI)
Outcome Measure.’’
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
measure specifications that do not
substantively change the nature of the
measure.
At the time of the CY 2013 OPPS/ASC
final rule, the NQF had endorsed the
pressure ulcer measure for the IRF
setting, and re-titled it to cover both
residents and patients within LTCH and
IRF settings, in addition to the Nursing
Home/Skilled Nursing Facility setting.
Although the measure had been
expanded to the IRF setting, we
concluded that it was not possible to
adopt the NQF endorsed measure
‘‘Percent of Residents or Patients with
Pressure Ulcers That Are New or
Worsened (short-stay)’’ (NQF #0678)
because it is a risk-adjusted measure.
Public comments revealed that the
‘‘Quality Indicator’’ section of the IRF–
PAI did not contain the data elements
that would be needed to calculate a riskadjusted measure. As a result, we
decided to: (1) adopt an application of
the NQF #0678 pressure ulcer measure
that was a non-risk-adjusted pressure
ulcer measure (numerator and
denominator data only); (2) collect the
data required for the numerator and the
denominator using the current version
of the IRF–PAI; (3) delay public
reporting of pressure ulcer measure
results until we could amend the IRF–
PAI to add the data elements necessary
for risk-adjusting NQF #0678, and then
(4) adopt the NQF-endorsed version of
the measure covering the IRF setting
through rulemaking (77 FR 68507).
a. National Healthcare Safety Network
(NHSN) Catheter Associated Urinary
Tract Infection (CAUTI) Outcome
Measure (NQF #0138)
In the CY 2013 OPPS/ASC final rule
we adopted the current version of NQF
#0138 NHSN Catheter Associated
Urinary Tract Infection (CAUTI)
Outcome Measure (replacing an
application of this measure which we
initially adopted in the FY 2012 IRF
PPS (76 FR 47874 through 47886). The
NQF endorsed measure applies to the
FY 2015 IRF PPS annual increase factor
and all subsequent annual increase
factors (77 FR 68504 through 68505).
Since the publication of the CY 2013
OPPS/ASC final rule, the NHSN CAUTI
measure has not changed. Furthermore,
we have not removed, suspended, or
replaced this measure and it remains an
active part of the IRF QRP. Additional
information about this measure can be
found at https://www.qualityforum.org/
QPS/0138. Our procedures for data
submission for this measure have also
remained the same. IRFs should
continue to submit their CAUTI
measure data to the Centers for Disease
Control and Prevention (CDC) NHSN.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
Details regarding submission of IRF
CAUTI data to NHSN can be found at
the NHSN Web site at https://
www.cdc.gov/nhsn/inpatient-rehab/
index.html.
We received several comments related
to this previously finalized measure,
NQF #0138, and some other previously
finalized measures, raising some
questions about our current policies.
While we greatly appreciate the
commenters’ views on such previously
finalized measures and policies, we did
not make any proposals relating to them
in the FY 2014 IRF PPS proposed rule
(78 FR 26880). As such, we will not, in
general, be addressing them here.
However, we will consider all of these
views for future rulemaking and
program development. We have
responded, however, to a few comments
in which commenters asked only for a
clarification related to an existing policy
and/or measure.
Comment: Several commenters,
including MedPAC, expressed that CMS
should focus on measures that reflect
the success of rehabilitation care,
mentioning specifically functional
improvement and/or discharge to
community. One commenter suggested
these measures be used instead of the
‘‘process of care measures related to
urinary tract infections and pressure
ulcers’’.
Response: We appreciate the
commenter’s suggestion. We would like
to thank MedPAC and the other
commenters for their comments. We
also agree that a discharge to
community measure would likely be
very important to beneficiaries and
serve as a useful corollary to the 30-day
readmissions measure we proposed in
the FY 2014 IRF PPS proposed rule,
because it reflects whether a patient
returns home, rather than returning
directly to the acute hospital or another
inpatient facility. We have developed a
strategic plan related to the types of
quality measures that we will propose
over the next several rulemaking cycles.
Patient experience of care and care
coordination measures, such as a
discharge to community measure, are
included in this plan. We have
previously discussed a measure of
discharge to community in one of the
IRF–QRP Technical Expert Panels. We
also agree with MedPAC’s suggestion
that adding quality measures that assess
functional improvement should be a
priority for the IRFQRP. At this time,
our quality measure development
contractor is completing the
development of quality measures that
specifically focus on outcomes related
to improvement of a patient’s functional
status, and these measures have been
PO 00000
Frm 00045
Fmt 4701
Sfmt 4700
47903
presented to the Measures Application
Partnership (MAP) to determine
whether the MAP at least supports the
direction of the concept behind these
measures (since the measures are not yet
complete). The MAP) and its functions
are described in detail at https://
www.qualityforum.org/map/. The
development of these measures has
necessitated several years of work,
involving testing, revisions, and expert
review. However, we are now close to
being in our final stages of the
development of these measures, and
will present them to the MAP this year.
Before proposing to adopt these
measures, we want to take all steps
necessary to ensure that the
introduction of functional measurement
into the IRF–QRP is comprehensive in
design so as to be meaningful to our
beneficiaries, Medicare and our
stakeholders.
Comment: One commenter expressed
concern about changes made by the CDC
to the CAUTI infection definitions in
2013, and the pending review with
further changes to the definition likely
in early 2014. This commenter believed
that instability of data between baseline
years and into CY 2014 can be expected
due to the changes in the CAUTI
definitions. One commenter expressed
support for the continued use of the
CAUTI measure, but suggested that
training could help to support a smooth
transition when the new reporting
definitions are introduced. The
commenter further encouraged CMS to
provide any training necessary that will
support a smooth transition when new
reporting definitions are introduced.
Response: According to the measure
steward, Centers for Disease Control and
Prevention (CDC), NHSN’s definition of
CAUTI did not change in 2013, and the
revised criteria in 2013 for what
constitutes an healthcare-associated
infection (HAI) amounts to providing
operational guidance—already widely
in use before the guidance was
published—that makes identifying HAIs
more consistent across reporting
healthcare facilities. There was no
change in the NQF measure
specification; the CAUTI measure
remains the same. As a result, CAUTI
data reported for infections occurring in
2013 can be compared to the CAUTI
baseline established using CAUTI date
reported for infections occurring in
2009. In short, there was no significant
change in the measure and the changes
in HAI criteria have no bearing on
reporting obligations. We will continue
to work with the NHSN to provide
provider training on any changes
affecting the IRF QRP.
E:\FR\FM\06AUR2.SGM
06AUR2
47904
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
Comment: One commenter expressed
concern about the adequacy of the risk
adjustment of the CAUTI measure,
especially with regard to its impact on
IRFs caring for patients with a spinal
cord injury.
Response: With regard to risk
adjustment, the CAUTI measure relies
on robust statistical analysis to inform
its risk adjustment methodologies to
ensure that the measure is accurately
reported. We will work with the CDC to
continue to collect data and to explore
the possibility of refining the CAUTI
measure through NQF measure
maintenance and future rulemaking, if
the change is substantive, as more data
is collected.
b. Application of Percent of Residents or
Patients With Pressure Ulcers That Are
New or Worsened (Short-Stay) (NQF
#0678)
In the CY 2103 OPPS/ASC final rule
(77 FR 68500 through 68507) we
finalized adoption of a non-riskadjusted application of this measure
using the current version of the IRF–
PAI. To adopt the NQF-endorsed
version of this measure, we must update
the existing IRF–PAI to include the
additional data elements necessary to
risk adjust this measure. We also
delayed public reporting of pressure
ulcer measure results until we amend
the IRF–PAI to add the data elements
necessary for risk adjusting NQF #0678
(77 FR 68507). We are not making any
changes to the application of measure
#0678 finalized in the CY 2013 OPPS/
ASC final rule for the FY 2015 and FY
2016 IRF PPS annual increase factors.
Furthermore, we have not removed,
suspended, or replaced this measure for
those specific annual increase factors
and the application of NQF #0678
remains an active part of the IRF QRP
for that purpose. Additional information
about this measure can be found at
https://www.qualityforum.org/QPS/0678.
Our procedures for data submission for
this measure also have remained the
same. IRFs should continue to collect
and submit pressure ulcer measure data
during CY 2013 using the IRF–PAI
released on October 1, 2012 for the FY
2015 IRF PPS annual increase factor.
Further, IRFs should continue to collect
and submit pressure ulcer measure data
during the first three quarters of CY
2014 using the IRF–PAI released on
October 1, 2012 for the FY 2016 IRF PPS
annual increase factor.
In the May 8, 2013 proposed rule (78
FR 26909 through 26924), we did
propose to adopt a revised version of the
IRF–PAI starting October 1, 2014 for the
FY 2017 PPS annual increase factor and
subsequent fiscal years annual increase
factors. We noted that the proposed
revisions to the IRF–PAI would allow
collection of data elements necessary for
risk adjustment of NQF #0678, which is
required by the NQF endorsed version
of the measure. We also proposed to
replace the current application of NQF
#0678 and adopt instead the NQF
endorsed version of this measure. We
have discussed these proposed changes
in more detail in section C. below.
TABLE 10—QUALITY MEASURES FINALIZED IN THE CY 2013 OPPS/ASC FINAL RULE AFFECTING THE FY 2015 IRF
ANNUAL INCREASE FACTOR AND SUBSEQUENT YEAR INCREASE FACTORS
NQF measure ID
Measure title
NQF #0138 ...........................
Application of NQF #0678 ....
National Health Safety Network (NHSN) Catheter-associated Urinary Tract Infection (CAUTI) Outcome Measure.+
Percent of Residents or Patients with Pressure Ulcers That are New or Worsened (Short-Stay).*
+ Using
CDC/NHSN.
* Using October 1, 2012 release of IRF–PAI.
C. New IRF QRP Quality Measures
Affecting the FY 2016 and FY 2017 IRF
PPS Annual Increase Factor, and
Subsequent Year Increase Factors
tkelley on DSK3SPTVN1PROD with RULES2
1. General Considerations Used for
Selection of Quality Measures for the
IRF QRP
In the May 8, 2013 proposed rule (78
FR 26909 through 26924), we noted that
the successful development of an IRF
quality reporting program that promotes
the delivery of high-quality healthcare
services in IRFs is our paramount
concern. We discussed many of the
factors we had taken into account in
selecting measures to propose in the
May 8, 2013 proposed rule (78 FR 26909
through 26924), and we refer readers
there for details about our selection
process. We do wish to note here that,
in our measure selection activities for
the IRF QRP, we must take into
consideration input we receive from a
multi-stakeholder group, the Measure
Applications Partnership (MAP), which
is convened by the NQF as part of a prerulemaking process that we have
established and are required to follow
under section 1890A of the Act. The
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
MAP is a public-private partnership
comprised of multi-stakeholder groups
convened by the NQF for the primary
purpose of providing input to CMS on
the selection of certain categories of
quality and efficiency measures, as
required by section 1890A(a)(3) of the
Act. By February 1st of each year, the
NQF must provide MAP input to CMS.
We have taken the MAP’s input into
consideration in selecting measures for
this rule. Input from the MAP is located
at https://www.qualityforum.org/Setting_
Priorities/Partnership/Measure_
Applications_Partnership.aspx. We also
take into account national priorities,
such as those established by the
National Priorities Partnership (NPP) at
https://www.qualityforum.org/Setting_
Priorities/NPP/National_Priorities_
Partnership.aspx, the HHS Strategic
Plan at https://www.hhs.gov/secretary/
about/priorities/priorities.html, and the
National Strategy for Quality
Improvement in Healthcare at https://
www.ahrq.gov/workingforquality/nqs/
nqs2012annlrpt.pdf. To the extent
practicable, we have sought to adopt
measures that have been endorsed by a
national consensus organization,
PO 00000
Frm 00046
Fmt 4701
Sfmt 4700
recommended by multi-stakeholder
organizations, and developed with the
input of providers, purchasers/payers,
and other stakeholders.
2. New Measures for the FY 2016 and
FY 2017 Annual Increase Factors
For the FY 2016 IRF PPS annual
increase factor, in addition to retaining
the previously discussed CAUTI and
Pressure Ulcer measures, we proposed
in the May 8, 2013 proposed rule (78 FR
26909 through 26924), to adopt one new
measure: Influenza Vaccination
Coverage among Healthcare Personnel
Measure (NQF #0431). In addition, for
the FY 2017 IRF PPS annual increase
factor, we proposed to adopt three
quality measures: (1) All-Cause
Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient
Rehabilitation Facilities, (2) Percent of
Residents or Patients Who Were
Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay)
(NQF #0680), and (3) the NQF endorsed
version of Percent of Residents or
Patients with Pressure Ulcers that are
New or Worsened (Short-Stay) (NQF
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
#0678). We discuss these measures in
more detail below in this final rule.
2. New Quality Measures for Quality
Data Reporting Affecting the FY 2016
IRF PPS Annual Increase Factor
tkelley on DSK3SPTVN1PROD with RULES2
a. IRF QRP Measure #1: Influenza
Vaccination Coverage Among
Healthcare Personnel (NQF #0431)
In the FY 2014 IRF PPS proposed rule
(78 FR 26880), we proposed to adopt the
CDC developed Influenza Vaccination
Coverage among Healthcare Personnel
(NQF #0431) measure that is currently
collected by the CDC via the NHSN.
This measure reports on the percentage
of IRF health care personnel (HCP) who
receive the influenza vaccination. We
noted that this measure was included on
the CMS’ List of Measures under
Consideration for December 1, 2012 and
that this measure was reviewed by the
MAP and was included in the MAP
input that was transmitted to CMS on
February 1, 2013, as required by section
1890A(a)(3) of the Act. The MAP fully
supported the use of this measure in the
IRF setting, indicating it promotes
alignment across quality reporting
programs (for example, with Long-Term
Care Hospital Quality Reporting
Program (LTCHQR Program) and
Hospital Inpatient Quality Reporting
Program (Hospital IQR)) and addresses a
core measure concept.
Health care personnel are at risk for
both acquiring influenza from patients
and transmitting it to patients, and
health care personnel often come to
work when ill.2 One early report of
health care personnel influenza
infections during the 2009 H1N1
influenza pandemic estimated 50
percent of infected health care
personnel had contracted the influenza
virus from patients or coworkers in the
healthcare setting.3
The CDC Advisory Committee on
Immunization Practices (ACIP)
guidelines recommends that all health
care personnel get an influenza
vaccination every year to protect
themselves and patients.4 Even though
levels of influenza vaccination among
health care personnel have slowly
increased over the past 10 years, less
2 Wilde JA, McMillan JA, Serwint J, et al.
Effectiveness of influenza vaccine in healthcare
professionals: A randomized trial. JAMA. 1999;
281:908–913.
3 Harriman K, Rosenberg J, Robinson S, et al.
Novel influenza A (H1N1) virus infections among
health-care personnel—United States, April–May
2009. MMWR Morb Mortal Wkly Rep. 2009; 58(23):
641–645.
4 Fiore AE, Uyeki TM, Broder K, et al. Prevention
and control of influenza with vaccines:
Recommendations of the Advisory Committee on
Immunization Practices (ACIP), 2010. MMWR
Recomm Rep. 2010. 59(08): 1–62.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
than 50 percent of health care personnel
each year received the influenza
vaccination until the 2009 and 2010
season, when an estimated 62 percent of
health care personnel got a seasonal
influenza vaccination. In the 2010 and
2011 season, 63.5 percent of health care
personnel reported an influenza
vaccination. Increased influenza
vaccination coverage among health care
personnel is expected to result in
reduced morbidity and mortality related
to influenza virus infection among
patients, aligning with the NQS’s aims
of better care and healthy people/
communities. This measure has been
finalized for reporting in the Hospital
IQR Program, LTCHQR Program, and
the Ambulatory Surgical Center Quality
Reporting Program (ASCQR Program).
We refer readers to the NHSN Manual,
Healthcare Personnel Safety Component
Protocol Module, Influenza Vaccination
and Exposure Management Modules,
which is available at the CDC Web site
at https://www.cdc.gov/nhsn/inpatientrehab/hcp-vacc/ for measure
specifications and additional details.
In the FY 2014 IRF PPS proposed rule
(78 FR 26909 through 26924), we
proposed that the Influenza Vaccination
Coverage Among Healthcare Personnel
measure (NQF #0431) have its own
reporting period to align with the
influenza vaccination season, which is
defined by the CDC as October 1st (or
when the vaccine becomes available)
through March 31st. We further
proposed that IRFs will submit their
data for this measure to the NHSN
(https://www.cdc.gov/nhsn/). The
National Healthcare Safety Network
(NHSN) is a secure Internet-based
healthcare-associated infection tracking
system maintained by the CDC and can
be utilized by all types of health care
facilities in the United States, including
IRFs. NHSN collects data via a webbased tool hosted by the CDC.
Information on the NHSN system,
including protocols, report forms, and
guidance documents can be found at the
provided web link: https://www.cdc.gov/
nhsn/. NHSN will submit data to CMS
on behalf of the facility. We also
proposed that for the FY 2016 IRF PPS
annual increase factor data collection
will cover the period from October 1,
2014 (or when the vaccine becomes
available) through March 31, 2015 (78
FR 26909 through 26924).
Details related to the use of NHSN for
data submission and information on
definitions, numerator data,
denominator data, data analyses, and
measure specifications for the Influenza
Vaccination Coverage among Healthcare
Personnel (NQF #0431) measure can be
found at https://www.cdc.gov/nhsn/
PO 00000
Frm 00047
Fmt 4701
Sfmt 4700
47905
inpatient-rehab/hcp-vacc/.
Because IRFs are already using the
NHSN for the submission of CAUTI
data, the administrative burden related
to data collection and submission for
this measure under the IRF QRP should
be minimal.
While IRFs can enter information in
NHSN at any point during the influenza
season for the healthcare personnel
(HCP) influenza vaccination measure
NQF #0431, data submission is only
required once per influenza season,
unlike the other measure finalized for
the IRF QRP that utilizes NHSN (CAUTI
measure NQF #0138). For example, IRFs
can choose to submit HCP influenza
vaccination data on a monthly basis.
However, each time an IRF submits
these data, it will be asked to provide a
cumulative total of vaccinations for the
‘‘current’’ influenza season. Thus,
entering this information at the end of
the influenza season would yield the
same total number of vaccinations. The
NHSN system will not track the
individual number of vaccinations on a
monthly basis, but, rather, will track the
cumulative total of vaccinations for the
‘‘current’’ influenza season. We
proposed that the final deadline
associated with this measure should
align with the other CMS deadline for
IRF HAI (CAUTI) reporting into NHSN,
which is May 15th. IRF QRP data
collection timelines and submission
deadlines are discussed below.
Also, as noted in the proposed rule,
data collection for this measure is not 12
months, as with other measures, but is
approximately 6 months (that is,
October 1st (or when the vaccine
becomes available) through March 31st
of the following year). This data
collection period is applicable only to
NQF #0431 Influenza Vaccination
Coverage Among Healthcare Personnel,
and not applicable to any other IRF QRP
measures, proposed or adopted, unless
explicitly stated. The measure
specifications for this measure can be
found at https://www.cdc.gov/nhsn/
inpatient-rehab/hcp-vacc/
and at https://www.qualityforum.org/
QPS/0431.
We sought public comments on the
Influenza Vaccination Coverage among
Healthcare Personnel (NQF #0431)
measure for the FY 2016 IRF PPS annual
increase factor and subsequent years.
The responses to public comments on
our adopting NQF #0431 are discussed
below in this section of the final rule.
Comment: Several commenters
expressed unconditional agreement
with our proposal to adopt the Influenza
Vaccination Coverage among Healthcare
Personnel measure in the IRF QRP.
However, a majority of commenters
E:\FR\FM\06AUR2.SGM
06AUR2
47906
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
expressed a conditional support for this
measure in which they support the use
of the measure by IRFs that are
freestanding hospitals, but do not
support the use of this measure by IRF
units that are affiliated with an acute
care facility. These commenters believe
that IRF units should be excluded from
this measure because most IPPS
hospitals include IRF unit employees in
reporting health care personnel
influenza vaccination rates to NHSN
under the IPPS Quality Reporting
program.
Response: The intent of NQF measure
#0431 is to incentivize full influenza
vaccination coverage of all healthcare
workers (HCWs) within a specific kind
of facility and to measure the extent to
which that goal is accomplished within
that facility. We regard an IRF unit that
is affiliated with an acute care facility to
be its own separate type of facility, with
its own responsibility for HCW
vaccination and data submission. The
submission of data by an IRF unit that
is affiliated with an acute care facility
will constitute location-specific
reporting to NHSN for the HCWs who
have worked within that specific unit.
These IRF units will need to account for
any staff that work within the unit for
one day or more between Oct 1st and
March 31st of a flu season and fall
within the 3 required categories of staff
as defined by the NHSN protocol,
including payroll employees, licensed
independent practitioners, and
students/trainees/volunteers. The acute
care facility will have the same
requirements for submission of data, but
will need to cover all of its inpatient
care units, which will include any
existing IRF units that are affiliated with
an acute care facility, and will
essentially be reporting facility-wide
counts. The data submitted for these
two separate requirements will never be
summed together.
Comment: Many of the commenters
requested that CMS clarify that the data
collection period for the influenza
vaccine begins on October 1st and not
at an earlier date, should the influenza
vaccination become available at any
time before October 1st.
Response: NHSN specifies the
reporting period for influenza vaccine
coverage in its protocol. Vaccine
coverage reporting, that is, measure
numerator data, is required based on
data collected from Oct 1 or whenever
the vaccine becomes available. This
statement ensures that if the vaccine is
available early, any vaccines given
before Oct 1 can be credited toward
vaccination coverage, and if the vaccine
is late, then the vaccination counts are
to begin as soon as possible after Oct 1.
For the denominator count, IRFs will
need to account for any staff that work
within the unit for 1 day or more
between Oct 1st and March 31st of a flu
season and fall within the 3 required
categories of staff as defined by the
NHSN protocol, including payroll
employees, licensed independent
practitioners, and students/trainees/
volunteers.
Final Decision: Having carefully
considered the comments we received
on the Influenza Vaccination Coverage
among Healthcare Personnel (NQF
#0431), we are finalizing the adoption of
this measure for use in the IRF QRP.
TABLE 11—SUMMARY OF QUALITY MEASURES AFFECTING THE FY 2016 IRF PPS ANNUAL INCREASE FACTOR
Continued Measure Affecting the FY 2015 Annual Increase Factor and Subsequent Year Annual Increase Factors:
• NQF #0138: National Health Safety Network (NHSN) Catheter-associated Urinary Tract Infection (CAUTI) Outcome Measure. +
Continued Measure Affecting the FY 2015 and FY 2016 Annual Increase Factors:
• Application of NQF #0678: Percent of Residents with Pressure Ulcers That are New or Worsened (Short-Stay). *
New IRF QRP Measure Affecting the FY 2016 IRF PPS Annual Increase Factor and Subsequent Year Increase Factors:
• NQF #0431: Influenza Vaccination Coverage among Healthcare Personnel. +
+ Using
CDC NHSN.
* Using October 1, 2012 release of IRF–PAI.
comments received and our responses to
comments are discussed below.
tkelley on DSK3SPTVN1PROD with RULES2
3. Quality Measures for Quality Data
Reporting Affecting the FY 2017 IRF
PPS Annual Increase Factor and
Subsequent Years
In the FY 2014 IRF PPS proposed rule
(78 FR 26909 through 26924), we
proposed to adopt 2 additional quality
measures and replace an existing quality
measure for the IRF QRP for the FY
2017 annual increase factor and
subsequent year increase factors. The
new measures we proposed are: (1) AllCause Unplanned Readmission Measure
for 30 Days Post Discharge from
Inpatient Rehabilitation Facilities, and
(2) Percent of Residents or Patients Who
Were Assessed and Appropriately Given
the Seasonal Influenza Vaccine (ShortStay) (NQF #0680). In addition, we
proposed to replace the non-risk
adjusted application of Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(short-stay) (NQF #0678) with adoption
of the NQF-endorsed version of this
measure. A summary of the public
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
a. IRF QRP Measure #1: All-Cause
Unplanned Readmission Measure for 30
Days Post Discharge From Inpatient
Rehabilitation Facilities
In the May 8, 2013 proposed rule (78
FR 26909 through 26924), we proposed
to adopt an All-Cause Unplanned
Readmission Measure for 30 Days Post
Discharge from Inpatient Rehabilitation
Facilities. This measure estimates the
risk-standardized rate of unplanned, allcause hospital readmissions for cases
discharged from an IRF who were
readmitted to a short-stay acute care
hospital or LTCH, within 30 days of an
IRF discharge. We noted that this is a
claims-based measure which will not
require reporting of new data by IRFs,
and hence, will not be used to
determine IRF reporting compliance for
the IRF QRP.
Addressing unplanned hospital
readmissions is a high priority for HHS
and CMS as our focus continues on
PO 00000
Frm 00048
Fmt 4701
Sfmt 4700
promoting patient safety, eliminating
healthcare associated infections,
improving care transitions, and
reducing the cost of healthcare.
Readmissions are costly to the Medicare
program and have been cited as
sensitive to improvements in
coordination of care and discharge
planning for patients.5 Although the
literature on readmissions is mainly
concerned with discharges from shortterm acute hospitals, the same issues of
discharge planning, communications
and coordination arise at discharge from
other inpatient facilities.
IRFs provide intensive rehabilitation
services to patients after an injury,
illness, or surgery. According to
MedPAC, the average length of stay for
most patients in an IRF is 13.1 days.6 In
2010, almost 360,000 Medicare Fee-forService (FFS) beneficiaries received care
5 Federal Register/Vol. 76, No. 160/Thursday,
August 18, 2011/Rules and Regulations, C1a.
6 MedPAC, Report to Congress, Medicare Payment
Policy, March, 2012. https://www.medpac.gov/
chapters/Mar12_Ch09.pdf.
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
in IRFs and cost the Medicare FFS
program over $6 billion dollars. The
unadjusted readmission rate to an IPPS
hospital in the 30 days following an IRF
discharge was about 15 percent.7 With
such a large proportion of patients being
readmitted to a hospital level of care, we
proposed a risk-adjusted measure of
readmission rate, the All-Cause
Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient
Rehabilitation Facilities. An IRF’s
readmission rate is affected by complex
and critical aspects of care, such as
communication between providers or
between providers and patients;
prevention of, and response to,
complications; patient safety; and
coordinated transitions to the
community or a less intense level of
care. While disease-specific measures of
readmission are useful in identifying
deficiencies in care for specific groups
of patients, they account for only a
small minority of total readmissions. By
contrast, a facility-wide, all-cause
readmission reflects a broader
assessment of the quality of care in IRFs,
and may consequently better promote
quality improvement and inform
consumers about quality.
While some readmissions are
unavoidable, such as those resulting
from the inevitable progression of
disease or worsening of chronic
conditions, readmissions may also
result from poor quality of care or
inadequate transitions between care
settings. Randomized controlled trials in
short-stay acute care hospitals have
shown that improvement in the
following areas can directly reduce
hospital readmission rates: Quality of
care during the initial admission;
improvement in communication with
patients, their caregivers and their
clinicians; patient education; predischarge assessment; and coordination
of care after discharge. Successful
randomized trials have reduced 30-day
readmission rates by 20 to 40
percent.8 9 10 11 12 13 14 and a 2011 meta7 Bernard SL, Dalton K, Lenfestey N F, Jarrett NM,
Nguyen KH, Sorensen AV, Thaker S, West ND.
Study to support a CMS Report to Congress: Assess
feasibility of extending the hospital-acquired
conditions—present on admission IPPS payment
policy to non-IPPS payment environments.
Prepared for the Centers for Medicare & Medicaid
Services (CMS Contract No. HHSM–500–T00007).
2011.
8 Jack BW, Chetty VK, Anthony D, Greenwald JL,
Sanchez GM, Johnson AE, et al. A reengineered
hospital discharge program to decrease
rehospitalization: a randomized trial. Ann Intern
Med 2009;150(3):178–87.
9 Coleman EA, Smith JD, Frank JC, Min SJ, Parry
C, Kramer AM. Preparing patients and caregivers to
participate in care delivered across settings: the
Care Transitions Intervention. J Am Geriatr Soc
2004;52(11):1817–25.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
analysis of randomized clinical trials
found evidence that interventions
associated with discharge planning
helped to reduce readmission rates,15
illustrating how hospitals may influence
readmission rates through best
practices.
Because many studies have shown
readmissions to be related to quality of
care, and that interventions have been
able to reduce 30-day readmission rates,
we believe it is appropriate to include
an all-condition readmission rate as a
quality measure in the IRF QRP.
Promoting quality improvements
leading to successful transitions of care
for patients moving from the IRF setting
to the community or another post-acute
care setting, and reducing preventable
facility-wide readmission rates, is
consistent with the National Quality
Strategy priorities of safer, better
coordinated care and lower costs.
Our approach to developing this
measure is not the same as, but is in
many ways very similar to NQFendorsed Hospital-Wide (HWR) RiskAdjusted All-Cause Unplanned
Readmission Measure (NQF #1789)
(https://www.qualityforum.org/
Publications/2012/07/Patient_
Outcomes_All-Cause_Readmissions_
Expedited_Review_2011.aspx) finalized
for the Hospital IQR Program in the FY
2013 IPPS/LTCH PPS Final Rule (FR 77
53521 through 53528). To the extent
appropriate, we have harmonized the
IRF measure with the HWR measure and
other measures of readmission rates
developed for post-acute care (PAC)
settings, including LTCHs. We have
10 Courtney M, Edwards H, Chang A, Parker A,
Finlayson K, Hamilton K. Fewer emergency
readmissions and better quality of life for older
adults at risk of hospital readmission: a randomized
controlled trial to determine the effectiveness of a
24-week exercise and telephone follow-up program.
J Am Geriatr Soc 2009;57(3):395–402.
11 Garasen H, Windspoll R, Johnsen R.
Intermediate care at a community hospital as an
alternative to prolonged general hospital care for
elderly patients: a randomized controlled trial. BMC
Public Health 2007;7:68.
12 Koehler BE, Richter KM, Youngblood L, Cohen
BA, Prengler ID, Cheng D, et al. Reduction of 30day post discharge hospital readmission or
emergency department (ED) visit rates in high-risk
elderly medical patients through delivery of a
targeted care bundle. J Hosp Med 2009;4(4):211–
218.
13 Naylor M, Brooten D, Jones R, Lavizzo-Mourey
R, Mezey M, Pauly M. Comprehensive discharge
planning for the hospitalized elderly. A randomized
clinical trial. Ann Intern Med 1994;120(12):999–
1006.
14 Naylor MD, Brooten D, Campbell R, Jacobsen
BS, Mezey MD, Pauly MV, et al. Comprehensive
discharge planning and home follow-up of
hospitalized elders: a randomized clinical trial.
JAMA 1999;281(7):613–20.
15 Naylor MD, Aiken LH, Kurtzman ET, Olds DM,
Hirschman KB.The Importance of Transitional Care
in Achieving Health Reform. Health Affairs 2011;
30(4):746–754.
PO 00000
Frm 00049
Fmt 4701
Sfmt 4700
47907
provided more details about these
measures and our attempts to harmonize
with them below.
The All-Cause Unplanned
Readmission Measure for 30 Days Post
Discharge from Inpatient Rehabilitation
Facilities measure assesses returns to
short-stay acute care hospitals or LTCHs
within 30 days of discharge from an IRF
to the community or another care setting
of lesser intensity. Patient readmissions
are tracked using Medicare claims data
for 30 days after discharge, to the date
of patient death, if the patient dies
within 30 days of discharge. 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 on the part of the
IRF.
A model developed by a CMS
measure development contractor
predicts admission rates while
accounting for patient demographics,
primary condition in the prior short
stay, comorbidities, and a few 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 facility. Similar
to the Hospital IQR Program hospitalwide readmission measure, the IRF QRP
measure is the ratio of the number of
risk-adjusted predicted unplanned
readmissions for each individual IRF,
including the estimated facility effect, to
the average number of risk-adjusted
predicted unplanned readmissions for
the same patients treated at the average
IRF. A ratio above one indicates a higher
than expected readmission rate, or
lower level of quality, while a ratio
below one indicates a lower than
expected readmission rate, or higher
level of quality. (The methodology
report detailing the development of the
IPPS hospital-wide measure and the
NQF report may be downloaded from:
https://www.qualityforum.org/
Publications/2012/07/Patient_
Outcomes_AllCause_Readmissions_
Expedited_Review_2011.aspx.)
The patient population includes IRF
patients who:
• Were discharged alive from the IRF.
• Had 12 months of Medicare Part A,
Fee-for-Service coverage prior to the IRF
stay.
• Had 30 days of Medicare Part A,
Fee-for-Service coverage post discharge.
• Had an acute care facility (IPPS,
CAH or psychiatric hospital) stay within
the 30 days prior to the IRF stay.
• Were aged 18 years or above when
admitted to the IRF.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47908
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
As with the Hospital IQR Program
hospital-wide readmission measure,
patients with medical treatment for
cancer are excluded. Studies of this
population that were reviewed for the
Hospital IQR Program readmission
measure showed them to have a
different trajectory of illness and
mortality than other patient
populations.16 The measure also
excludes patients who died during the
IRF stay, IRF patients under the age of
18, or IRF patients discharged against
medical advice (AMA).
Readmissions that are not included in
the measure are:
• Transfers from an IRF to another
IRF or acute care facility.
• Readmissions within the 30-day
window that are usually considered
planned due to the nature of the
procedures and principal diagnoses of
the readmission.
• IRF stays with data that are
problematic. (The Medicare data files
occasionally have anomalous records
that indicate a person is in two facilities
or stays that overlap in dates, or are
otherwise potentially erroneous or
contradictory.)
The planned readmission list includes
the planned procedures specified in the
Hospital-Wide All-Cause Unplanned
Readmission (HWR) Measure (NQF
#1789) used in the Hospital IQR
Program, plus other procedures that we
determined in consultation with
technical expert panels. In addition to
the list of planned procedures is a list
of diagnoses (provided at the link below
in the planned readmission criteria),
which, if found as the principal
diagnosis on the readmission claim,
would indicate that the procedure
occurred during an unplanned
readmission. The planned readmissions
criteria may be found at https://www.
cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/IRFQuality-Reporting/Downloads/DRAFTSpecifications-for-the-Proposed-AllCause-Unplanned-30-day-Post-IRFDischarge-Readmission-Measure.pdf
with a link to the latest planned
readmissions criteria used in the HWR
at the end of Table 1.
A discharged patient is tracked until
one of the following occurs: (1) The 30day period ends; (2) the patient dies; or
(3) the patient is readmitted to an acute
level of care (short or long term). If
multiple readmissions occur, only the
first is considered for this measure. If
the readmission is unplanned, it is
counted as a readmission in the measure
16 National Quality Forum. ‘‘Patient Outcomes:
All-Cause Readmissions Expedited Review 2011’’.
July 2012. pp12.
VerDate Mar<15>2010
21:13 Aug 05, 2013
Jkt 229001
rate. If the readmission is planned, the
readmission is not counted in the
measure rate. The occurrence of a
planned readmission ends further
tracking for readmissions in the 30-day
window following discharge from the
IRF.
Readmission rates are risk-adjusted
for patient case-mix characteristics,
independent of quality. The risk
adjustment modeling estimates the
effects of patient characteristics on the
probability of readmission so they can
be adjusted out when reporting the
readmission rates. The risk-adjustment
model for IRFs accounts for
demographic characteristics, principal
diagnosis, comorbidities, case-mix
group in the IRF, length of stay in the
prior acute care facility, critical care
days in the prior acute care facility,
number of acute care facility stays in the
prior year, and the occurrence of various
surgery types in the prior acute care
facility stay. In modeling IRF
readmissions, all patients are included
in a single model. We did not divide
patients into groups clinically, modeling
separate patient types separately as was
done in the IPPS HWR measure. In the
HWR there are five patient cohorts, each
modeled separately, and a combined
score for the facility. All IRF patients are
modeled as one group, both because
IRFs have a substantially smaller patient
population, restricting the ability to
create reasonably large subgroups, and
the technical expert panel did not
recommend any such stratification.
While the HWR measure used 1 year
of data, the smaller IRF patient
population led us to merge 2 years of
data for the IRF QRP. This approach is
similar to that used by the Hospital IQR
Program condition-specific readmission
measures, such as that for heart attack
and heart failure patients, which use 3
years of claims data. Increasing sample
size by merging multiple years produces
more precise estimates of the effects of
all the risk adjusters and increases the
sample size associated with each
facility. Larger patient samples are
generally better for meaningfully
distinguishing facility performance. We
proposed this measure under the
exception authority in section
1886(m)(5)(D)(ii) of the Act for the IRF
QRP. This section provides that in the
case of a specified area or medical topic
determined appropriate by the Secretary
for which a feasible and practical
measure has not been endorsed by the
entity with a contract under section
1890(a) of the Act, the Secretary may
specify a measure that is not so
endorsed as long as due consideration is
given to measures that have been
PO 00000
Frm 00050
Fmt 4701
Sfmt 4700
endorsed or adopted by a consensus
organization identified by the Secretary.
We noted in the proposed rule we had
not been able to identify an NQFendorsed readmission measure that was
appropriate for the IRF setting. In 2012,
NQF endorsed hospital-wide
readmission measures, the National
Committee for Quality Assurance
(NCQA) measure intended for health
plans, Plan All-Cause Readmissions
(NQF #1768), and CMS’ Hospital-Wide
All-Cause Unplanned Readmission
Measure (HWR) (NQF #1789), of which
the latter is the model for the All-Cause
Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient
Rehabilitation Facilities measure,
proposed in the FY 2014 IRF PPS
proposed rule. This measure was
present on CMS’s List of Measures
Under Consideration, and the most
recent MAP Pre-Rulemaking Report
noted that ‘‘readmission measures are
also examples of measures that MAP
recommends be standardized across
settings, yet customized to address the
unique needs of the heterogeneous PAC/
LTC population’’ (https://
www.qualityforum.org/Publications/
2013/02/MAP_Pre-Rulemaking_Report__February_2013.aspx (pp. 177–180)).
Although the MAP supported the
direction of this measure, they
cautioned that the readmission measure
required further development. The MAP
has also continually noted the need for
‘‘care transition measures in PAC/LTC
performance measurement programs’’
and stated that ‘‘setting-specific
admission and readmission measures
under consideration would address this
need.’’ 17
In the May 8, 2013 proposed rule, we
stated our intention to seek NQF
endorsement of the All-Cause
Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient
Rehabilitation Facilities measure. We
noted that because this is a claims-based
measure not requiring reporting of new
data by IRFs, this measure will not be
used to determine IRF reporting
compliance for the IRF QRP. We also
stated that we expected to begin
reporting feedback to IRFs on
performance of this measure in CY 2016
and that initial provider feedback will
be based on CY 2013 and CY 2014
Medicare FFS claims data related to IRF
readmissions and that the readmission
measure will be part of the IRF public
reporting program once public reporting
17 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.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
is implemented. We noted that details
pertaining to this measure can be found
on the IRF Quality Reporting Program
Web site at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/IRF-QualityReporting/. We invited
stakeholders to submit public comments
in response to our proposal to adopt the
All-Cause Unplanned Readmission
Measure for 30 Days Post Discharge
from Inpatient Rehabilitation Facilities.
A summary of the public comments
received and our responses to comments
are discussed below.
Comment: Many commenters have
expressed concern that CMS has not yet
sought and obtained NQF endorsement
for the IRF readmission measure.
Response: We are aware this measure
is not yet NQF-endorsed for the IRF
setting and are working to submit the
measure for NQF review and
endorsement. Currently, we are working
with contractors to submit the measure
for NQF endorsement in October 2013.
For the time being, we have chosen to
adopt this measure by exercising our
authority to finalize a non-NQF
endorsed measure when NQF endorsed
measures are not available or
appropriate for a setting and the
Secretary has given due consideration to
measures that have been endorsed or
adopted by a consensus organization
identified by the Secretary. We were not
able to find a measure that was
appropriate for the IRF setting.
Comment: Several commenters
requested that additional risk adjustors
be added to the risk adjustment model
for the IRF readmission measure,
including patient data such as function
and social support, on the IRF–PAI.
Response: The proposed readmission
measure is a risk-standardized
readmission measure that adjusts for
case-mix differences based on the
clinical status of the patient at the time
of admission to the IRF. That is, the
measure is risk-adjusted for certain key
variables that are clinically relevant or
have been found to have strong
relationships with the outcome,
including age group, sex, comorbid
diseases, history of repeat admissions.
We also include as adjusters the IRF
case-mix groups (CMGs). The 92 CMGs
are patient classes based on information
on the IRF–PAI and are reported on
claims. The CMG assigned to a patient
contain information on the reason for
IRF treatment (impairment group),
functional status, and sometimes
cognitive status and age group. These
data elements from claims further
enhance risk adjustment which, along
with information from the IRF–PAI, are
sufficient without requiring linking the
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
IRF–PAI assessments themselves. We
will investigate in the future if
including data elements, such as
function and social support, directly
from the IRF–PAI would produce
substantive improvement of the model.
Comment: Several commenters
suggested that socioeconomic status and
social factors be added to the risk
adjustment model for the IRF
readmission measure.
Response: The inclusion of factors
related to socioeconomic status (SES)
has been raised in the context of the
IPPS Hospital IQR measures and our
policy in that program omits them as
explicit risk adjusters. Medicaid dual
eligibility, which is related to income, is
a socioeconomic factor, and is also not
accounted for explicitly in IQR
measures. The IRF measure harmonizes
with the other readmission measures in
that respect (the IQR and the final longterm care hospital readmission
measure). The effect of SES is similar in
the case of IRFs to the effects in the IPPS
setting and the reasoning for not
explicitly accounting for SES is similar.
The effect of levels of SES is captured
to a great extent by other variables
included in the model. The readmission
measure is a risk-standardized
readmission measure that adjusts for
case-mix differences based on the
clinical status of the patient at the time
of admission to the hospital. That is,
they are risk-adjusted for certain key
variables (for example, age, sex,
comorbid diseases, and a history of
repeat admissions) that are clinically
relevant and/or have been found to have
strong relationships with the outcome.
To the extent that race or SES results in
certain patient groups having a worse
medical condition profile, those factors
are accounted for in the measure.
These measures are not otherwise
adjusted for other factors such as race or
English language proficiency. We
believe such additional adjustments are
not appropriate because the association
between such patient factors and health
outcomes can be due, in part, to
differences in the quality of health care
received by groups of patients with
varying race/language/SES. Differences
in the quality of health care received by
certain racial and ethnic groups may be
obscured if the measures risk-adjust for
race and ethnicity. In addition, riskadjusting for patient race, for instance,
may suggest that hospitals with a high
proportion of minority patients are held
to different standards of quality than
hospitals treating fewer minority
patients. We appreciate the concerns of
hospitals that care for
disproportionately large numbers of
disadvantaged populations. Our
PO 00000
Frm 00051
Fmt 4701
Sfmt 4700
47909
analysis indicates that better quality of
care is achievable regardless of the
demographics of the hospital’s patients.
Comment: Many commenters,
including MedPAC, suggested the IRF
readmission measure should focus on
avoidable or related hospitalizations.
Response: The issue of all-cause
readmissions as opposed to a more
focused set of readmission types has
been raised in other contexts such as the
HWR IQR measure. Discussions with
technical experts have led us to prefer
using an all-cause measure rather than
a condition-specific readmissions
measure. A measure of avoidable or
related readmissions is possible when
the population being measured is
narrowly defined and certain
complications are being targeted. For
broader measures, a narrow set of
readmission types is not practical. In
addition, readmissions may be clinically
related even if they are not
diagnostically related. A patient may
have comorbid conditions that are
unrelated to the reason for
rehabilitation. If not properly dealt with
in discharge planning a readmission for
such a condition may become more
likely. One of the primary purposes of
a readmission measure is to encourage
improved transitions at discharge, a
choice among discharge destinations
and care coordination. A readmission
can occur that is less related to the
primary condition being treated in the
IRF than to the coordination of care
post-discharge. That said, we have
chosen to reduce the all-cause
readmission set by excluding
readmissions that are normally for
planned or expected diagnosis and
procedures. We augmented the research
for the Hospital IQR set of planned
readmissions for the IRF setting with
recommendations and input from a TEP
in the field of post-acute care (including
IRFs). Nearly 9 percent of readmissions
are considered planned. In the case
where the readmission is due to a
random event, such as a car accident,
we expect these events to be randomly
distributed across hospitals.
Comment: Several commenters
indicated that the readmission measure
may have the unintended consequence
of reducing access to IRF care.
Response: We recognize that in some
cases, hospital readmission will occur.
Hospital readmission is not considered
as a ‘‘never event’’ that hospitals are
expected to reduce to zero. The measure
of hospital readmission is risk-adjusted
to account for the factors that increase
this readmission risk, so that hospitals
with a disproportionately larger share of
patients who are at high risk for
readmission do not perform worse on
E:\FR\FM\06AUR2.SGM
06AUR2
47910
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
the quality measure due to factors out of
their control. We appreciate the
commenters’ concerns but the risk
adjustment is intended to adjust for
more complex patients so that access to
care will not be reduced. Nonetheless,
as with all quality measures that we
have implemented, we will examine IRF
data to monitor for potential unintended
consequences.
Comment: Some commenters
suggested that more than 2 years of data
be included in the readmissions
measure to increase sample size.
Response: The 2 years of data for each
reporting period is a compromise
between sample size and timeliness. In
this case the total number of IRF stays
in 1 year of national data is much
smaller than the number of IPPS stays.
However, 2 years of data generally yield
good sample sizes at the facility level.
Ninety-five percent of facilities have
more than 100 patients averaged in their
measure. We do not think that 3 years
of data is needed at this time. However,
we will continue to monitor this data
over time and if there is a significant
change in number of IRF discharges in
total or in individual facilities we will
reconsider the data requirement.
Final Decision: Having carefully
considered the comments we received
on the All-Cause Unplanned
Readmission Measure for 30 Days Post
Discharge from Inpatient Rehabilitation
Facilities, we are finalizing the adoption
of this measure for use in the IRF QRP.
We will also continue to seek NQF
endorsement of the All-Cause
Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient
Rehabilitation Facilities measure.
b. IRF QRP Quality Measure #2: Percent
of Residents or Patients Who Were
Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay)
(NQF #0680)
In the May 8, 2013 proposed rule (78
FR 26909 through 26924), we proposed
to add the NQF #0680 Percent of
Residents or Patients who were assessed
and Appropriately Given the Seasonal
Influenza Vaccination (Short-Stay)
measure to the IRF QRP, and we
proposed to collect the data for this
measure through the addition of data
items to the Quality Indicator section of
the IRF–PAI. We noted that this
measure was on CMS’s list of measures
under consideration that were reviewed
by the MAP and was included in the
MAP input that was transmitted to
CMS, as required by the pre-rulemaking
process in section 1890A(a)(3) of the
Act. The MAP panel supported the use
of this measure in the IRF setting, noting
that it promotes alignment across
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
settings and addresses a core measure
concept.
Although influenza is prevalent
among all population groups, the rates
of death and serious complications
related to influenza are highest among
those ages 65 and older and those with
medical complications that put them at
higher risk. The CDC reports that an
average of 36,000 Americans die
annually from influenza and its
complications, and most of these deaths
are among people 65 years of age and
over.18 In 2004, approximately 70,000
deaths were caused by influenza and
pneumonia, and more than 85 percent
of these deaths were among the
elderly.19 Given that many individuals
receiving health care services in IRFs
are elderly and/or have several medical
conditions, many IRF patients are
within the target population for
influenza immunization.20 21
We have also proposed to add the
data elements needed for this measure,
as an influenza data item set, to the
Quality Indicator section of the IRF–PAI
and that data for this measure will be
collected using a revised version of the
IRF–PAI. Our proposed revision of the
IRF–PAI includes a new data item set
designed to assess patients’ influenza
vaccination status. The revised IRF–PAI
would become effective on October 1,
2014. We noted that these proposed data
set items are harmonized with data
elements (O0250: Influenza Vaccination
Status) from the Minimum Data Set
(MDS) 3.0 and LTCH CARE Data Set
item sets 22 23 and that the specifications
18 Centers for Medicare & Medicaid Services
(2011, May). Adult Immunization: Overview.
Retrieved from https://www.cms.gov/
Immunizations/.
19 Gorina Y, Kelly T, Lubitz J, et al. (2008,
February). Trends in influenza and pneumonia
among older persons in the United States. Aging
Trends no. 8. Retrieved from https://www.cdc.gov/
nchs/data/ahcd/agingtrends/08influenza.pdf.
20 Centers for Disease Control and Prevention.
(2008, September). Influenza e-brief: 2008–2009 flu
facts for policymakers. Retrieved from https://
www.cdc.gov/washington/pdf/flu_newsletter.pdf.
21 Zorowitz, RD. Stroke Rehabilitation Quality
Indicators: Raising the Bar in the Inpatient
Rehabilitation Facility. Topics in Stroke
Rehabilitation 2010; 17 (4):294–304.
22 Centers for Medicare & Medicaid Services.
MDS 3.0 Item Subsets V1.10.4 for the April 1, 2012
Release. Retrieved from https://www.cms.gov/
NursingHomeQualityInits/
30_NHQIMDS30TechnicalInformation.asp.
23 The LTCH CARE Data Set Version 2.00, the
data collection instrument for the submission of the
Percent of Residents or Patients with Pressure
Ulcers That are New or Worsened (Short-Stay)
measure and the Percent of Residents or Patients
Who Were Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay) measure, is
currently under review by the Office of
Management and Budget (OMB) in accordance with
the Paperwork Reduction Act (PRA) https://
www.gpo.gov/fdsys/pkg/FR-2013-02-01/pdf/201302155.pdf. The LTCH CARE Data Set Version 1.01
PO 00000
Frm 00052
Fmt 4701
Sfmt 4700
and data elements for this proposed
measure are available in the MDS 3.0
QM User’s Manual available on our Web
site at https://www.cms.gov/
NursingHomeQualityInits/Downloads/
MDS30QM-Manual.pdf.
For purposes of this measure, the
influenza vaccination season consists of
October 1st (or when the vaccine
becomes available) through March 31st
each year. We proposed that while an
IRF’s compliance with reporting quality
data for this measure will be based on
the calendar year, the measure
calculation and public reporting of this
measure (once public reporting is
implemented) will be based on the
influenza vaccination season starting on
October 1 (or when vaccine becomes
available) and ending on March 31 of
the subsequent year.
The IRF–PAI Training Manual will
indicate how providers should complete
these items during the time period
outside of the vaccination season (that
is, prior to October 1st or when vaccine
becomes available and after March 31 of
the following year). The measure
specifications for this measure, Percent
of Residents or Patients Who Were
Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay)
(NQF #0680), can be found on the CMS
Web site: https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
NursingHomeQualityInits/
NHQIQualityMeasures.html. Measure
specifications are located in the
download titled: MDS 3.0 QM User’s
Manual V6.0. Additional information on
this measure can also be found at https://
www.qualityforum.org/QPS/0680.
In the May 8, 2013 proposed rule, we
invited public comment on our proposal
to use the Percent of Residents or
Patients Who Were Assessed and
Appropriately Given the Seasonal
Influenza Vaccine (Short-Stay) (NQF
#0680) measure for the FY 2017 IRF PPS
annual increase factor and subsequent
years. A summary of the public
comments received and our responses to
comments are discussed below.
Comment: Several commenters
indicated that they did not support the
patient immunization measure because
it is not a core focus of care in IRFs.
Response: While we appreciate the
commenters’ point of view, influenza is
a serious illness, especially for patients
who are elderly, immuno-compromised,
or who have recently undergone
surgery—characteristics that describe
was approved on April 24, 2012 by OMB in
accordance with the PRA. The OMB Control
Number is 0938–1163. Expiration Date April 30,
2013.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
many of the patients in IRFs. CDC
reports that pneumonia and influenza
were the 5th leading cause of death
amongst individuals 65 and older and
that between 1997 and 2007, deaths
among people aged 65 and older
accounted for 87.9 percent of deaths
related to pneumonia and influenza.
Providing appropriate influenza
vaccination is an important preventative
measure that is the responsibility of
healthcare providers in all settings.
Although many patients may have
already been offered and/or received the
influenza vaccine in the acute care
setting, the ultimate goal is that 100
percent of patients are assessed for
appropriate receipt of the influenza
vaccine, and achieving this goal requires
the participation of all healthcare
providers.
Comment: Several commenters
expressed concern that the NQF #0680
Percent of Residents or Patients Who
Were Assessed and Appropriately Given
the Seasonal Influenza Vaccine is
redundant because patients are offered
many opportunities to receive the
influenza vaccination prior to admission
into the IRF and are highly likely to
have already received the influenza
vaccine in the acute care hospital.
Several commenters also noted that the
patient influenza measure may lead to
over-vaccination of patients.
Response: We appreciate the
comments and acknowledge the
commenters’ concern for redundancy
and over-vaccination. The specifications
for the Percent of Patients or Residents
Who Were Assessed and Appropriately
Given the Seasonal Influenza Vaccine
(short stay) measure are written so that
clinicians can document if patients have
already received the influenza vaccine
for the current influenza season. The
numerator statement of the measure
includes patients who received the
influenza vaccine, either inside or
outside the IRF, for the current
influenza season. An IRF can report that
a patient received the vaccine prior to
admission to the IRF and that it should
not re-vaccinate the patient for purposes
of being able to report the patient
receiving a vaccination in the IRF. We
acknowledge that facilities will need to
adhere to the principles of proper care
coordination and documentation to
avoid over-immunization and underimmunization. However, the
specifications for the measure are
designed to encourage facilities to only
vaccinate when the patient has not
already received the vaccination.
Comment: Several commenters
requested guidance on how to track
down the influenza vaccination history
of patients.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
Response: We refer commenters to the
measure description and specifications
of the NQF-endorsed measure at the
NQF Web site https://
www.qualityforum.org/QPS/0680.
Further, to the extent that the
commenters are asking us to issue
guidance on proper vaccine
documentation for purposes of ensuring
that the receiving facility has an
accurate immunization history, we agree
that care coordination is essential to
avoid over- as well as underimmunization. The influenza
vaccination measure, however, was not
designed to offer guidance to providers
on how to vaccinate. The measure is
specified to assess if the patient was
vaccinated, where the patient was
vaccinated (if they were vaccinated), or
why the vaccination was not given (if
the patient was not vaccinated). Patients
who were not vaccinated due to a
contraindication and patients who
refused the vaccination are both
counted in the numerator and
accounted separately in the numerator
of the measure. In a situation where
vaccination status is unknown, we
would expect that the IRF provider
would make a clinical judgment on
whether or not to vaccinate a patient,
taking into account the patient’s
medical history and current health
status, as well as the existing policy of
their IRF on vaccination. The IRF must
only report the decision it made; that is,
whether the vaccination was or was not
given. The measure does not require an
IRF to provide a vaccination that was
not appropriate due to a
contraindication or a patient refusal, or
to provide a vaccination to a patient
who was already given a vaccination
outside of the IRF. We encourage all
IRFs to vaccinate according to their
facilities’ policies and the best clinical
judgment of the medical providers
treating each individual patient and to
document the reason for the vaccination
decision in the patient’s medical record.
Comment: Many commenters
requested clarification about the data
collection period for the patient
influenza vaccine.
Response: Starting with 2014–2015
Influenza season data collection will be
required for all patients in the IRF for
1 or more days between October 1 and
March 31. Clinicians can report that the
reason a given patient did not receive
the vaccine was that the patient was not
in the facility during the current
influenza vaccination season. Consistent
with NQF #0431, the vaccination
measure for healthcare personnel, it is
the vaccinations received for patients in
the IRF during the influenza season
(October 1st to March 31st) that will be
PO 00000
Frm 00053
Fmt 4701
Sfmt 4700
47911
included in measure calculations and
for the purpose of public reporting.
Final Decision: After careful
consideration of the public comments
received, we are finalizing our proposal
to adopt the Percent of Residents or
Patients Who Were Assessed and
Appropriately Given the Seasonal
Influenza Vaccine (Short-Stay) (NQF
#0680) measure for the FY 2017 IRF PPS
annual increase factor and subsequent
years. We are additionally clarifying
that data collection will begin starting
with the 2014–2015 Influenza season.
Data collection for this and all
subsequent influenza seasons will be
from October 1 through March 31 of the
following year. All data collection and
submission guidelines will be addressed
in the IRF Quality Reporting Manual.
c. IRF QRP Quality Measure #3: Percent
of Residents or Patients With Pressure
Ulcers That Are New or Worsened
(Short-Stay) (NQF #0678)—Adoption of
the NQF-Endorsed Version of This
Measure
In the May 8, 2013 proposed rule (78
FR 26909 through 26924), we have
proposed to adopt the NQF-endorsed
version of the NQF #0678 pressure ulcer
measure, with data collection beginning
October 1, 2014 using the revised
version of IRF–PAI, for quality reporting
affecting the FY 2017 and subsequent
years IRF PPS annual increase factors.
We also proposed to remove the current
non-risk adjusted application of this
measure when the revised IRF–PAI is
implemented on October 1, 2014. We
noted in the proposed rule that, until
September 30, 2014, IRFs should
continue to submit pressure ulcer data
using the IRF–PAI released on October
1, 2012 for the purposes of data
submission requirements for the FY
2015 and FY 2016 IRF PPS increase
factors. Details about our proposed
changes to the IRF–PAI and additional
information regarding data submission
are discussed in the proposed rule (78
FR 26909 through 26924).
We invited public comment in
response to our proposed removal of the
currently adopted non-risk adjusted
application of the Percent of Residents
or Patients with Pressure Ulcers That
Are New or Worsened (short-stay) (NQF
#0678) and the adoption of the NQFendorsed version of the Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened (NQF
#0678). A summary of the public
comments received and our responses to
comments are discussed below in this
final rule.
Comment: Several commenters
expressed support for our proposal to
remove the currently adopted non-risk
E:\FR\FM\06AUR2.SGM
06AUR2
47912
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
adjusted application of the Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(short-stay) (NQF #0678) and adopt the
NQF endorsed version of the Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short Stay) (NQF #0678) for the FY
2017 annual increase factor. These
commenters also expressed general
support for the addition of the risk
adjustment factors associated with this
measure to the IRF–PAI.
Response: We appreciate the
commenters for their supportive
comments and their feedback for the
measure to the IRF–PAI.
Final Decision: After careful
consideration of the comments received,
we are finalizing our proposal to adopt
the NQF-endorsed version of the
Percent of Residents or Patients with
Pressure Ulcers That Are New or
Worsened (short-stay) (NQF #0678)
measure beginning on October 1, 2014,
using the revised version of the IRF–
PAI. We are also finalizing our proposal
to remove the existing non-risk adjusted
application of NQF #0678 from the IRF
QRP effective October 1, 2014.
TABLE 12—SUMMARY OF MEASURES AFFECTING THE FY 2017 IRF PPS ANNUAL INCREASE FACTOR AND SUBSEQUENT
YEAR INCREASE FACTORS
Continued Measure Affecting the FY 2015 Annual Increase Factor:
• NQF #0138: National Health Safety Network (NHSN) Catheter-associated Urinary Tract Infection (CAUTI) Outcome Measure.+
New IRF QRP Measure Affecting the FY 2016 IRF PPS Annual Increase Factor:
• NQF #0431: Influenza Vaccination Coverage among Healthcare Personnel.+
New IRF QRP Measures Affecting the FY 2017 IRF PPS Annual Increase Factor:
• All-Cause Unplanned Readmission Measure for 30 Days Post Discharge from Inpatient Rehabilitation Facilities∧
• NQF #0680: Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (ShortStay).*
• NQF #0678: Percent of Residents or Patients with Pressure Ulcers That are New or Worsened (Short-Stay).*
∂ Using
CDC/NHSN.
* Using the IRF–PAI released October 1, 2014.
Fee-For-Service claims data.
∧ Medicare
tkelley on DSK3SPTVN1PROD with RULES2
D. Changes to the IRF–PAI That Are
Related to the IRF Quality Reporting
Program
1. General Background
A version of the IRF–PAI has been in
use in the IRF setting since January 1,
2002, when IRFs first began receiving
payment under the IRF PPS. IRFs must
submit a completed IRF–PAI for each
Medicare Part A, B, and C patient that
is admitted and discharged from the
IRF.
The IRF PPS utilizes information from
the IRF–PAI to classify patients into
distinct groups based on clinical
characteristics and expected resource
needs. Separate payments are calculated
for each group, including the
application of case and facility level
adjustments available at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
InpatientRehabFacPPS/.
In the FY 2014 proposed rule, we
proposed to release an updated version
of the IRF–PAI on October 1, 2014 (78
FR 26909–26924) . Proposed revisions
included data elements that will (1)
allow for risk adjustment of the NQF
#0678 Percent of Residents or Patients
with Pressure Ulcers That Are New or
Worsened (Short-Stay), (2) allow for
voluntary submission of more detailed
data collection related to NQF #0678
Percent of Residents or Patients with
Pressure Ulcers That Are New or
Worsened (Short-Stay), and (3) allow for
data collection for NQF #0680 Percent
of Residents or Patients Who Were
Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay).
VerDate Mar<15>2010
21:13 Aug 05, 2013
Jkt 229001
We also proposed to adopt a new
numbering schema for the IRF–PAI.
What we have proposed includes both
mandatory and voluntary additions to
the IRF–PAI. Collection of voluntary
data elements by IRFs will have no
impact on measure calculations or on
our determination of whether the IRF
has met the reporting requirements
under the IRF QRP. In contrast, failure
to complete mandatory data elements
may result in non-compliance with the
IRF QRP requirements and subject the
facility to a 2 percentage point reduction
in its annual increase factor. We have
provided more details about these items
below at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/
Spotlights-Announcements.html under
‘‘CMS–10036’’.
The October 1, 2014 release of the
IRF–PAI that we proposed, inclusive of
all the changes that we intend to finalize
here, and information about the IRF–
PAI submission process can be found at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
InpatientRehabFacPPS/Downloads/
508c-IRF-PAI-2014.pdf. A PRA package
for the revised IRF–PAI discussed here
has been submitted for the Office of
Management and Budget’s (OMB)
review and approval. The PRA package
documents are available for viewing on
the CMS PRA Listings Web page at:
https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing-Items/
CMS1216518.html?DLPage=1&DLFilter=
IRF-PAI&DLSort=1&DLSortDir=
PO 00000
Frm 00054
Fmt 4701
Sfmt 4700
descending. The PRA package form
number is cms-10036, and the OMB
control number for this PRA package is
0938–0842.
a. Background Related to Collection of
Pressure Ulcer Data Elements Using the
IRF–PAI
In the FY 2012 IRF PPS final rule, we
finalized a proposal to adopt an
application of the NQF #0678 ‘‘Percent
of Residents with Pressure Ulcers That
Are New or Worsened (Short-Stay)’’
measure for use in the IRF QRP,
beginning with the IRF PPS annual
increase factor for FY 2014. We also
finalized our proposal to collect the data
for this pressure ulcer measure using the
IRF–PAI. In order to comply with
section 3004 of the Affordable Care Act
requirements, we deleted the set of
outdated pressure ulcer assessment
items that were voluntary quality
questions and had been located in the
‘‘Quality Indicator’’ section of the IRF–
PAI and replaced them with a new set
of pressure ulcer quality measure data
items that were designed to capture the
data necessary for the finalized
application of NQF #0687. These items
were modeled after the MDS 3.0 items,
numbered 48A to 50D, and changed the
status of the pressure ulcer data items
from ‘‘voluntary’’ to ‘‘mandatory.’’
These revisions to the IRF–PAI went
into effect on October 1, 2012.
Since the publication of the FY 2012
final rule (76 FR 47836) we have
received numerous comments about the
current version of the IRF–PAI from IRF
providers, provider organizations, and
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
advocacy groups. In the CY 2013 OPPS/
ASC final rule, we discussed a number
of specific public comments related to
pressure ulcer data that we received in
response to the CY 2013 OPPS/ASC IRF
proposed rule (77 FR 68506). In that CY
2013 proposed rule, we proposed to
update the application of NQF #0678
that we had previously incorporated
into the IRF QRP by instead
incorporating the actual NQF-endorsed
version of this measure (77 FR 45196).
NQF #0678 is a risk adjusted measure.
Commenters expressed specific
concerns regarding the ability of the
data elements in the IRF–PAI to
sufficiently risk-adjust the measure. We
agreed that there were limitations
related to the risk adjustment data items
that are on the IRF–PAI that went into
effect on October 1, 2012, impacting the
ability to calculate the measure using all
of the risk adjustment related covariates.
As a result, the CY 2013 OPPS/ASC
final rule adopted an application of
#0680 without risk-adjustment for FY
2015 and subsequent years (77 FR
68507).
In the proposed rule, we noted that in
response to the comments and feedback
received in previous rules discussed
above, we intended to propose
modifications to the data items in both
the admission and discharge IRF–PAI
assessments as discussed below.
2. Revisions to the IRF–PAI To Add
Mandatory Risk Adjustment Data Items
for NQF #0678 Percent of Residents or
Patients With Pressure Ulcers That Are
New or Worsened (Short-Stay)
In the FY 2014 IRF PPS proposed rule
(78 FR 26909–26924), we proposed to
update the current IRF–PAI to include
data elements that are necessary to risk
adjust the Percent of Residents or
Patients with Pressure Ulcers That Are
New or Worsened (Short-Stay) (NQF
#0678). These updates to the IRF–PAI
include the addition of the following
indicator boxes to the IRF–PAI
admission assessment: (1) Peripheral
Vascular Disease, (2) Peripheral Arterial
Disease, and (3) Diabetes. The additions
would be placed in the Quality
Indicators section of the revised IRF–
PAI.
We further determined that risk
adjustment factors related to height and
weight had inadvertently been left off of
the revised version of the IRF–PAI that
became effective on October 1, 2012. We
proposed to add height and weight to
the IRF–PAI to correct this oversight
into the ‘‘Medical Information’’ section
of the IRF–PAI. As a general rule, we
would place all data items related to
quality reporting and quality measures
within the Quality Indicator section of
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
the IRF–PAI. However, the height and
weight items have a dual purpose
because they can be used for the
calculation of Body Mass Index (BMI),
which is used as one part of the analysis
for compliance with the 60 percent rule.
Even though the height and weight
items are placed in the ‘‘Medical
Information’’ section of the IRF–PAI,
they are also being added to the IRF–
PAI for calculating risk adjustment for
the pressure ulcer measure. Failure to
provide height and weight information
could result in a finding of noncompliance with the reporting
requirements.
We invited public comment on our
proposal to include data elements
required for risk-adjustment of NQF
#0678 Percent of Patients with Pressure
Ulcers That Are New or Worsened
measure as mandatory data collection
elements in the revised IRF–PAI. Below
is a summary of public comments
received for the additional elements
required for risk-adjustment of the
pressure ulcer measure, and our
responses to these comments.
Comment: One commenter questioned
the use of peripheral artery disease
(PAD), peripheral vascular disease
(PVD), and diabetes mellitus (DM) as
risk adjusters for the pressure ulcer
quality measure.
Response: Peripheral Arterial Disease,
Peripheral Vascular Disease, and
Diabetes are all conditions affecting
perfusion and oxygenation, which are
considered to impact risk of pressure
ulcer development. Conditions causing
issues of sensory perception (for
example, peripheral neuropathy) or an
alteration to intact skin (dry skin,
erythema and other skin alterations)
also are considered to impact risk of
pressure ulcer development (Pressure
Ulcer Prevention Clinical Practice
Guideline, NPUAP). Additionally,
statistical analyses showed that these
factors were found to be significantly
associated with the development of
pressure ulcers when risk adjustment
models were tested in a large sample of
IRF patients.
Comment: Several commenters
requested that CMS consider adding
impairment group as a risk adjuster for
the pressure ulcer measure.
Response: When developing the
pressure ulcer quality measure, we
reviewed the literature and obtained
input from clinicians on which factors
should be tested as potential risk
adjustors. Various measurements of
functional status/functional impairment
were tested on a large sample of IRF
patients, and were not found to be
statistically significant in the population
as a whole. We will continue to analyze
PO 00000
Frm 00055
Fmt 4701
Sfmt 4700
47913
this measure as more data is collected
and will consider testing additional risk
adjustors for future iterations of the
measure.
Comment: A commenter expressed
concern that the adoption of the NQFendorsed version of the pressure ulcer
measure ‘‘may be too premature.’’ This
commenter noted that CMS recently
held a technical expert panel to discuss
the potential development of a
standardized set of pressure ulcer
measurement items to be used across
multiple healthcare settings (referred to
as ‘‘cross-setting’’), and therefore, this
commenter suggested that CMS delay
implementing the revised pressure ulcer
items.
Response: It was necessary for us to
finalize development of the proposed
updates to the pressure ulcer data items
for the October 1, 2014 IRF–PAI release
prior to work on the cross-setting
pressure ulcer measures because of the
significant amount of time required to
implement such a data item set.
However, we will continue to work on
improving the data collection efforts to
ensure that the most relevant patient
information is obtained.
Final Decision: After careful
consideration of the public comments
we received, we are finalizing our
proposal to include the additional risk
adjustment elements discussed above to
the IRF–PAI for the purpose of riskadjustment for NQF #0678 Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short-Stay).
3. Revisions to the IRF–PAI To Add
Voluntary Data Items Related to NQF
#0678 Percent of Residents or Patients
With Pressure Ulcers That Are New or
Worsened (Short-Stay)
The pressure ulcer measure
numerator for the NQF #0678 endorsed
version of the ‘‘Percent of Residents or
Patients with Pressure Ulcers That Are
New or Worsened (Short-Stay)’’ measure
looks at the number of patients with a
target assessment during the selected
time window who have one or more
Stage 2 through 4 pressure ulcer(s) that
are new or that have worsened
compared with the previous assessment.
According to the NQF Web site, in its
description of NQF #0678, ‘‘Stage 1
pressure ulcers are excluded from this
measure because recent studies have
identified difficulties in objectively
measuring them across different
populations.’’ The measure numerator
also does not include what is referred to
as ‘‘unstageable’’ pressure ulcers, which
we describe below. The data that that
has been mandatory for IRFs to report
under the IRF QRP are those that met
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47914
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
the requirements of the application of
NQF #0678 that we finalized in the CY
2013 OPPS/ASC final rule (as
incorporated into the 2012 version of
the IRF PAI), which reflected the same
staging for pressure ulcers as the NQFendorsed version of the measure. We
have proposed to include in the 2014
version of the IRF–PAI additional
mandatory data items to accommodate
the risk adjustment requirements of the
NQF-endorsed version of this measure.
We have received feedback from
providers through a variety of sources
(including a May 2, 2012 in-person
training and special open door forums
that occurred on November 29, 2011;
April 19, 2012; July 26, 2012; August 16,
2012; September 20, 2012; and October
18, 2012) in regard to the pressure ulcer
items on the IRF–PAI. Additionally, we
have received feedback in the form of
questions from IRF providers submitted
to the IRF Quality Reporting Program
Helpdesk.
We learned from provider feedback
that a majority of IRF providers want the
ability and flexibility to document
information about all stages of pressure
ulcers (numerical stages 1 through 4 and
pressure ulcers that are not numerically
stageable due to suspected deep tissue
injury, slough and/or eschar, or nonremovable devices, known as
unstageable pressure ulcers), in addition
to data on the stages of pressure ulcers
required for the quality measure, and
that they felt this extended
documentation would allow them to
track the evolution of pressure ulcers.
We further learned that many providers
felt that it is important to have a way to
document information about healed
pressure ulcers because they wanted us
to know about these positive outcomes.
In response to the feedback we
received from providers, we proposed to
add voluntary data items to the IRF–PAI
Quality Indicators section, designed to
address providers’ concerns about the
adequacy of current pressure ulcer data
items. As modified, our proposed
admission assessment consists of 2 main
topics: (1) Unhealed Pressure Ulcers;
and (2) Pressure Ulcer Risk Conditions.
Also, the discharge assessment consists
of 2 main topics: (1) Unhealed Pressure
Ulcers; and (2) Healed Pressure Ulcers.
Within each main topic there are subtopics that contain a set of questions.
The provider is asked to document how
many pressure ulcers, if any, the patient
has at each stage upon admission. We
have added new questions that extend
beyond stages 2 through 4 pressure
ulcers, covering the presence of stage 1
pressure ulcers, as well as unstageable
pressure ulcers that are due to a nonremovable device or dressing, to slough
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
or eschar, or deep tissue injury. We note
that the discharge assessment differs
somewhat from the admission
assessment with regard to the pressure
ulcer questions. A copy of the 2014 IRF–
PAI can be found at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
InpatientRehabFacPPS/IRFPAI.html.
We have added this greater specificity
to the pressure ulcer items to allow
providers to document pressure ulcers
in more detail. In describing the
inadequacy they perceived in the
present pressure ulcer items, providers
described such situations as those in
which a patient is admitted into an IRF
with an unstageable pressure ulcer that
is a suspected deep tissue injury (DTI).
During the course of the IRF stay the
DTI evolves into a stage 3 and, after
several days, worsens to a stage 4. On
the current version of the IRF–PAI,
providers have no ability to document
the presence of an unstageable pressure
ulcer that existed when the patient was
admitted. Whether or not the IRF
believes there is an unstageable pressure
ulcer, the IRF must document that the
patient had no pressure ulcers on the
admission assessment. However later,
after the DTI worsens to a stage 3, if the
IRF judges from the nature of the
pressure ulcer that it was extremely
likely to have been present at
admission, the IRF would have to go
back and change their documentation
on the admission assessment to reflect
that the patient actually had a stage 3
pressure ulcer upon admission. Upon
discharge, the IRF would document that
the patient has a stage 4 pressure ulcer.
With the new pressure ulcer data items
for 2014, the IRF will be able to
document the presence of the
unstageable pressure ulcer or suspected
DTI on the admission assessment. The
revisions to the IRF–PAI for 2014 will
allow the IRF to give a more complete
and accurate picture of the progression
of this pressure ulcer when the patient
is discharged.
While Stage 1 and unstageable
pressure ulcers are not part of the NQF
#0678 endorsed version of the ‘‘Percent
of Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short-Stay),’’ and are not mandatory,
we nonetheless believe that it is
appropriate and important for us to
collect this information. As the measure
steward for this measure, CMS would
like to gather and analyze data regarding
Stage 1 and unstageable pressure ulcers
to help determine if any modification to
the existing measure should be made.
This data could also help us determine
if any additional pressure ulcer
measures should be developed. For
PO 00000
Frm 00056
Fmt 4701
Sfmt 4700
example, collecting data about Stage 1
pressure ulcers could provide us with
information that would allow us to
assess whether these pressure ulcers can
now be objectively measured across
different populations.
Additionally, as we have noted above,
some pressure ulcers that are present on
admission can become stageable and
then worsen to a higher stage during the
IRF stay. Access to data on these kinds
of situations would assist us in
determining whether including
unstageable and Stage 1 measures in the
measure results may be appropriate in
the future. We might accomplish this by
expanding the current measure or
developing an entirely new pressure
ulcer measure.
We invited public comment on our
proposed revisions to the IRF–PAI of
voluntary items related to the staging of
pressure ulcers. We received the
following public comments in response
to our proposals for the addition of
these voluntary pressure ulcer items to
the IRF–PAI.
Comment: Several commenters
suggested that stage 1 pressure ulcers
should not be collected on the IRF–PAI.
Response: We obtained feedback from
providers on the pressure ulcer items on
the IRF–PAI released in October 2012
during Provider Trainings, Open Door
Forums, and via the Quality Reporting
Program Helpdesk. Based on the
feedback we received, we learned that
many IRF providers want the ability to
document as much information as
possible about all types of pressure
ulcers and feel that this will help them
to better track the evolution of pressure
ulcers. Because it would be useful to us,
as well as providers, to obtain complete,
accurate information about the quality
of care being provided in IRFs, we
included fields for the documentation of
all stages of pressure ulcers, including
Stage 1 and Unstageable pressure ulcers.
However, NQF #0678 covers only Stages
2–4 pressure ulcers. Stage 1 pressure
ulcers are not included in the quality
measure. If a facility does not wish to
report data on these pressure ulcers,
they are under no obligation to do so.
Comment: Several commenters
requested that each IRF–PAI quality
indicator pressure ulcer item be labeled
as to whether it is mandatory or
voluntary. Another commenter
recommended that the voluntary IRF–
PAI quality indicator pressure ulcer
items be segregated from the mandatory
items, or that CMS in some way on the
IRF–PAI indicate which of the items are
voluntary.
Response: We have posted on our
Web site a detailed matrix that identifies
which data elements will be required,
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
and which will be voluntary (available
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/
Spotlights-Announcements.html) and
this matrix will also be incorporated
into the final IRF PAI Training Manual
which will be posted on CMS IRF PPS
Web site. We do not directly indicate on
the IRF–PAI which items are mandatory
versus which items are voluntary. These
designations are subject to change, and
although we can address such changes
in rulemaking, the IRF–PAI is only
released biannually. Thus, our ability to
change these designations on the IRF–
PAI itself is limited and could lead to
provider confusion should these
designations not align with current
policy because they have changed
during the interim year when we do not
have a new release of the IRF–PAI.
Comment: One commenter suggested
that if a pressure ulcer is discovered
after the removal of a ‘‘non-removable
device or other dressing’’ during the IRF
stay, and there was no documentation of
this wound from the discharging
hospital, this should not be counted on
the IRF–PAI due to issues of attribution.
Response: Assessment items
collecting data on unstageable pressure
ulcers are voluntary. However, if a
numerically staged pressure ulcer is
observed when a non-removable device/
dressing is removed, and the pressure
ulcer is still present at the time of
discharge, that pressure ulcer will be
reported on the IRF–PAI at discharge. If
there were documentation that the
pressure ulcer was present at admission
at the same stage, and it did not worsen
to a higher stage during the stay, then
the pressure ulcer would not be
considered new or worsened. The item
in the proposed October 1, 2014 IRF–
PAI ‘‘Unstageable due to NonRemovable Device or Dressing’’ should
be used on admission when there is
documentation of a known pressure
ulcer that cannot be fully visualized and
staged due to a non-removable device.
Comment: Several commenters
indicated that the IRF–PAI is now too
long and causes undue burden.
Response: We obtained feedback from
providers in October of 2012 on the IRF
PAI during Provider Trainings, Open
Door Forums, and via the Quality
Reporting Program Helpdesk. Based on
the feedback we received, providers
wanted the ability to provide as much
information as possible to truly track the
evolution of pressure ulcers, so in order
to accommodate these providers, we are
adding voluntary items. However, only
those pressure ulcer items required to
calculate the quality measure NQF
#0678, Percent of Patients or Residents
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
with Pressure Ulcers That Are New or
Worsened (Short Stay), are required in
order for providers to avoid a 2
percentage point reduction of the
applicable IRF PPS annual increase
factor. Therefore, if a facility finds
completing the additional data items
burdensome, it is under no obligation to
do so. Please refer to the 2014 IRF–PAI
training manual for the voluntary/
mandatory status of each item.
Comment: One commenter requested
that CMS consider capturing the degree
to which a pressure ulcer has healed by
discharge.
Response: Pressure ulcer healing and
treatment is a complex clinical issue
that is difficult to capture in
standardized assessment items. The
IRF–PAI does not record incremental
improvement, but instead captures only
condition on admission and discharge,
based on staging pressure ulcers, to
avoid undue burden of data collection
on facilities. Possible indicators of
healing are numerous and not always
accurate. These include surface area
reduction, a common indicator for
tracking the healing of pressure ulcers;
however, we do not believe it is an
appropriate data element to include in
the IRF–PAI because it is not the sole
determinant of healing. Development of
granulation tissue, decrease in
erythema, decrease in exudate, reepithelialization, etc., are also other
ways to document pressure ulcer
healing. We cannot add data elements
for all possible indicators. Also, many
IRF stays are short, averaging 13 days,
and we have no expectation that severe
pressure ulcers will heal completely
during this timeframe. If the patient is
admitted with a full thickness pressure
ulcer which will likely not be healed in
approximately 13 days, it would simply
be noted in the patient’s record as full
thickness on discharge. The IRF would
not experience any negative impact
from a quality reporting standpoint in a
situation such as this, because this
information is not required for purposes
of NQF #0678. Also, from a more
general perspective, quality measures
are not designed to track a full set of
details about the progress of any
individual patient, but rather to include
just enough information to register a
patient’s decline or improvement while
in the care of a facility. This kind of
assessment can assist us in monitoring
the overall quality of facilities to ensure
patients are receiving high-quality care
and to identify facilities whose practices
can be improved.
Final Decision: After giving careful
consideration to the public comments
received in response to our proposal to
add new voluntary pressure ulcer items
PO 00000
Frm 00057
Fmt 4701
Sfmt 4700
47915
to the IRF–PAI, we are finalizing the
proposal to add the new pressure ulcer
items that were posted on the IRF PPS
Web page and as part of the IRF–PAI
PRA package.
4. Revisions to the IRF–PAI To Add
Mandatory Data Items Related to NQF
#0680 Percent of Residents or Patients
Who Were Assessed and Appropriately
Given the Seasonal Influenza Vaccine
(Short-Stay)
We have proposed to make changes to
the IRF–PAI discharge assessment to
include the addition of elements
necessary to report data for the
proposed measure, Percent of Residents
or Patients Who Were Assessed and
Appropriately Given the Seasonal
Influenza Vaccine (Short-Stay) (NQF
#0680). These items will be based on the
items from the MDS 3.0 and LTCH
CARE Data Set items.24 25 There are 3
data elements that will be collected in
relation to this measure: Two are used
to calculate the measure, and a third is
used to ensure internal consistency and
data accuracy. The items are as follows:
• Did the patient receive the
influenza vaccine in this facility for this
year’s influenza vaccination season?
• Date influenza vaccine was
received, and
• If influenza vaccine not received,
state reason.
These items and questions allow the
IRF to report if and when an influenza
vaccine was given at the facility. They
also allow the IRF to indicate why a
vaccine was not given if that is the case.
Further details on the specifications and
data elements for this measure are
available in the MDS 3.0 QM User’s
Manual available on our Web site at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
NHQIQualityMeasures.html. Measure
specifications are located in the
download titled: MDS 3.0 QM User’s
Manual V6.0. Measure information is
24 Centers for Medicare & Medicaid Services.
MDS 3.0 Item Subsets V1.10.4 for the April 1, 2012
Release. Retrieved from https://www.cms.gov/
NursingHomeQualityInits/
30_NHQIMDS30TechnicalInformation.asp.
25 The LTCH CARE Data Set Version 2.00, the
data collection instrument for the submission of the
Percent of Residents or Patients with Pressure
Ulcers That are New or Worsened (Short-Stay)
measure and the Percent of Residents or Patients
Who Were Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay) measure, is
currently under review by the Office of
Management and Budget (OMB) in accordance with
the Paperwork Reduction Act (PRA) https://
www.gpo.gov/fdsys/pkg/FR-2013-02-01/pdf/201302155.pdf. The LTCH CARE Data Set Version 1.01
was approved on April 24, 2012 by OMB in
accordance with the PRA. The OMB Control
Number is 0938–1163. Expiration Date April 30,
2013.
E:\FR\FM\06AUR2.SGM
06AUR2
47916
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
also available at https://
www.qualityforum.org/QPS/0680.
In the proposed rule, we invited
public comment on our proposed
revisions to the IRF–PAI related to NQF
#0680 Percent of Residents or Patients
Who Were Assessed and Appropriately
Given the Seasonal Influenza Vaccine
(Short-Stay). The comments we received
were related to our proposal to adopt
the measure itself, and not on how we
were proposing to modify the IRF–PAI.
For a summary of comments and
responses on this issue, please see
section XIV.3.b. of this final rule.
Final Decision: After careful
consideration of the public comments
we received, we are finalizing our
proposal to modify the IRF–PAI
discharge item set to add the 3 data
elements for collecting data for NQF
#0680.
5. Revisions to the IRF–PAI Related to
Numbering of Quality Indicator Items
In the revised IRF–PAI, we include
changes in the numbering scheme used
in the Quality Indicator section of the
IRF–PAI from a ‘‘consecutive numbering
scheme’’ for numbering assessment
items to a numbering scheme that
allows greater flexibility for item
removal and insertion. Problems arise
with a consecutive numbering scheme
when items are removed or new ones
are inserted because this changes the
numbers of some or all of the items
around them. Other CMS post-acute
care data collection vehicles, such as the
MDS 3.0 and the LTCH CARE Data Set,
have adopted a more flexible numbering
schema that allows insertion or removal
of items without requiring renumbering
of the remaining items. We proposed to
adopt a similar numbering schema in
the revised IRF–PAI. A less flexible
numbering system that necessitates
renumbering items on the IRF–PAI in
the event of such changes will result in
a given item number having very
different meanings on different versions
of the IRF–PAI item set.
For more details about our plans for
changes to the IRF–PAI, see https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
InpatientRehabFacPPS/IRFPAI.html.
In the May 8, 2013 proposed rule, we
invited public comments about our
proposal to change the numbering
scheme used in the quality indicator
section of the IRF–PAI. A summary of
the public comments received and our
responses to comments are discussed
below.
Comment: We did not receive any
comments in response to our proposal
to change the type of numbering used
on the quality indicator section of the
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
IRF–PAI from a consecutive scheme to
a numbering scheme similar to that used
in the MDS 3.0. We did, however,
receive comments requesting that page
numbers be added to the IRF–PAI. The
commenters suggested that because this
document was being increased from 3 to
9 pages in length as a result of the
proposed changes to the Quality
Indicator section of the IRF–PAI then
the page numbering should be added.
Another commenter requested that page
numbers be added to the IRF–PAI
because ‘‘numbering the IRF–PAI pages
will help keep it in correct order, since
it is filed in the medical record.’’
Response: We agree with the
commenters that adding page
numbering to the IRF–PAI can assist
IRFs in keeping the document in correct
order. We also acknowledge that the
proposed changes to the Quality
Indicator section of the IRF–PAI will
significantly increase the length of this
document.
Final Decision: After careful
consideration of the public comments
we received, we are finalizing our
proposal to adopt a flexible numbering
scheme (similar to that used in MDS
3.0) into the Quality Indicator section of
the IRF–PAI. In addition, we will add
general page numbering to the IRF–PAI
document.
E. Change in Data Collection and
Submission Periods for Future Program
Years
The FY 2012 final rule (76 FR 47836)
included an initial framework for the
IRF QRP. In that rule we also finalized
the initial quality measures to be used
in the IRF QRP, stated how data for
these measures would to be collected,
and selected the time periods for the
data collection and reporting of the
quality data.
The FY 2012 final rule (76 FR 47836)
also finalized the initial IRF QRP data
reporting cycle, affecting the FY 2014
annual increase factor, as beginning on
October 1, 2012 and ending on
December 31, 2012. Beginning in 2013
for the FY 2015 annual increase factor,
and for subsequent year annual increase
factors, we finalized that quality
reporting cycles would be based on a
full calendar year (CY) cycle (76 FR
47879).
When there are new measures added
to the quality reporting program that
will be collected on the IRF–PAI, that
data collection instrument must be
updated accordingly. The next update to
the IRF- PAI will take place on October
1, 2014. Under current policy, the IRF
QRP data collection cycle for the FY
2016 annual increase factor will not
begin until January 1, 2014.
PO 00000
Frm 00058
Fmt 4701
Sfmt 4700
In the FY 2014 proposed rule, we
proposed to change the IRF–PAI data
collection periods for the FY 2016 and
FY 2017 annual increase factors in order
to align with the release of the new
version of the IRF–PAI on October 1,
2014. We have also proposed to shorten
the data collection period impacting the
FY 2016 IRF PPS annual increase factor
to 9 months, so that the FY 2017
reporting periods can begin on October
1, 2014 using the new version of the
IRF–PAI. Under this proposal, the next
data collection period would run from
January 1, 2014 to September 30, 2014
and affect the IRF PPS annual increase
factor for FY 2016.
We further proposed to start fiscal
year data collection periods beginning
on October 1, 2014, and data collected
for discharges during October 1, 2014 to
September 30, 2015 will affect the FY
2017 IRF PPS annual increase factor. In
addition, we proposed that data
collection will continue on FY cycles
unless there is an event that requires
that this cycle be amended. We noted
that, in the event the established cycles
must be changed, we will make this
apparent to the public and follow all
necessary processes to make the change.
Finalizing these proposals will result in
having 2 separate data collection and
submission schedules for IRF–PAI and
NHSN based measures. We provide
more details on this distinction below.
We invited public comment on our
proposal to alter the IRF–PAI data
collection periods impacting the FY
2016 and FY 2017 increase factors in a
way that aligns with the release of the
next version of the IRF–PAI instrument.
A summary of the public comments
received and our responses to comments
are discussed below.
Comment: Several commenters
expressed support for this proposal. We
did not receive any comments that
included objections to our proposal to
change the data collection and
submission timeframe for data collected
using the IRF–PAI from a calendar year
basis to a fiscal year basis, beginning on
October 1, 2014. Likewise, no
commenters objected to our continuing
collection of NHSN data on a calendar
year basis.
Response: We thank those
commenters for their support of the
proposed changes to the data collection
and submission cycle for data collected
using the IRF–PAI from a calendar to a
fiscal year basis.
Comment: Several commenters
expressed their support for our proposal
to continue data collection and
submission of NHSN measures data on
a calendar year basis beginning on
October 1, 2014 with the exception of
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
the Influenza Vaccination Among
Healthcare Personnel Measure (NQF
#0431). These commenters expressed an
opinion that IRF units within acute care
hospitals should be permitted to attest
that their health care personnel flu
vaccination measure data is reported
through the acute care hospital’s
reporting, thereby automatically
receiving credit for reporting in the IRF
QRP.
Response: We thank those
commenters for their support of our
proposal to continue to report data to
NHSN on a calendar year. We do not
agree, however, that IRF units located
within IPPS hospitals should be
permitted to attest to the submission of
(NQF #0431) Influenza Vaccination
among Healthcare Personnel measure
data as part of the IPPS data. We will
require all IRFs to report data for this
measure. For a full discussion of this
specific issue, as well as details about
this measure, see section XIV.3.C.2
above ‘‘IRF QRP Measure #1: Influenza
Vaccination Coverage among
Healthcare Personnel (NQF #0431)’’.
Final Decision: After careful
consideration of the public comments
received, we are finalizing our proposal
to change the data collection timeframe
for data submitted via the IRF–PAI to a
fiscal year basis beginning on October 1,
2014, and to continue data collection of
data that is reported via NHSN on a
calendar year basis.
1. Implementation of Data Submission
Deadlines for the IRF QRP
In the FY 2012 IRF PPS final rule we
stated that details regarding data
submission and reporting requirements
would be posted on the CMS Web site
at https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/
index.html no later than January 31,
2012 (76 FR 47879). Further data
submission details for the IRF QRP were
posted on the CMS IRF QRP Web site on
January 31, 2012, as promised. In
addition, data submission details were
disseminated to IRFs at various times
from January 31, 2012 to December 31,
2012, through an in-person training held
on May 2, 2012, Open Door Forums,
list-serve announcements, IRF QRP Web
page postings and responses to IRF QRP
Helpdesk inquiries. In these
communications, we announced that
the final data submission deadline for
the IRF QRP would be May 15th for all
measures finalized for the FY 2014
annual increase factor and each
subsequent years annual increase factor.
We realize the value in providing
clear submission deadlines for the IRF
QRP and we believe that we should
provide deadlines that clearly
distinguish between data submitted
using the NHSN and data submitted
using the IRF–PAI. Further, it is
important to have distinct deadlines at
which point data submitted afterward,
including data modifications and
corrections, could not be used for
reporting or IRF PPS annual increase
factor determinations. For purposes of
47917
the FY 2016 and subsequent year IRF
PPS annual increase factors, and for the
purposes of applying quarterly
deadlines for public reporting purposes,
we proposed the inclusion of quarterly
data submission deadlines in addition
to the previously finalized deadlines.
We believe that clear submission
deadlines this will ensure timely
submission of data.
2. Quarterly Timelines for Submitting
Data Using the IRF–PAI
For the purposes of submitting quality
data using the IRF–PAI for the IRF QRP,
we have proposed new quarterly
timeframes described below that we
believe will provide sufficient time for
IRFs to meet quality reporting
requirements and allow us to harmonize
IRF QRP data submission deadlines
with the LTCHQR Program and Hospital
IQR. Beginning with data collection and
reporting impacting the FY 2016 annual
increase factor, we proposed that IRFs
follow the deadlines presented in the
tables below to complete submission of
data for each quarter. For each quarter
outlined in the tables below during
which IRFs are required to collect data,
we proposed a final deadline occurring
approximately 135 days (or
approximately 4 and 1⁄2 months) after
the end of each quarter by which all
data collected during that quarter must
be submitted. We believe that this is a
reasonable amount of time to allow IRFs
to submit data and make any necessary
corrections. We have summarized these
deadlines in the tables below.
TABLE 13—TIMELINES FOR SUBMISSION OF IRF QRP PROGRAM QUALITY DATA USING IRF–PAI * FOR FY 2016 IRF PPS
ANNUAL INCREASE FACTOR +: APPLICATION OF NQF #0678 PERCENT OF RESIDENTS OR PATIENTS WITH PRESSURE
ULCERS THAT ARE NEW OR WORSENED (SHORT-STAY)
Quarter
IRF–PAI Data submission
deadline for corrections of the
IRF QRP
IRF–PAI Data collection period
FY 2016 Annual Increase Factor
Quarter 1 ....................................
Quarter 2 ....................................
Quarter 3 ....................................
January 1, 2014–March 31, 2014 .....................................................................
April 1, 2014–June 30, 2014 .............................................................................
July 1, 2014–September 30, 2014 ....................................................................
August 15, 2014.
November 15, 2014.
February 15, 2015.
* Using October 1, 2012 release of IRF–PAI.
+ FY 2016 APU determination is based on 3 quarters of data submission for the pressure ulcer measure.
tkelley on DSK3SPTVN1PROD with RULES2
TABLE 14—TIMELINES FOR SUBMISSION OF IRF QRP PROGRAM QUALITY DATA USING IRF–PAI * FOR FY 2017 IRF PPS
ANNUAL INCREASE FACTOR: NQF #0678 PERCENT OF RESIDENTS OR PATIENTS WITH PRESSURE ULCERS THAT ARE
NEW OR WORSENED (SHORT-STAY), AND NQF #0680 PERCENT OF RESIDENTS OR PATIENTS WHO WERE ASSESSED
AND APPROPRIATELY GIVEN THE SEASONAL INFLUENZA VACCINE (SHORT-STAY)
Quarter
IRF–PAI Data submission
deadline for corrections of the
IRF QRP
IRF–PAI Data collection period
FY 2017 Annual Increase Factor
Quarter 1 ....................................
VerDate Mar<15>2010
19:58 Aug 05, 2013
October 1, 2014–December 31, 2014 ..............................................................
Jkt 229001
PO 00000
Frm 00059
Fmt 4701
Sfmt 4700
E:\FR\FM\06AUR2.SGM
06AUR2
May 15, 2015.
47918
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
TABLE 14—TIMELINES FOR SUBMISSION OF IRF QRP PROGRAM QUALITY DATA USING IRF–PAI * FOR FY 2017 IRF PPS
ANNUAL INCREASE FACTOR: NQF #0678 PERCENT OF RESIDENTS OR PATIENTS WITH PRESSURE ULCERS THAT ARE
NEW OR WORSENED (SHORT-STAY), AND NQF #0680 PERCENT OF RESIDENTS OR PATIENTS WHO WERE ASSESSED
AND APPROPRIATELY GIVEN THE SEASONAL INFLUENZA VACCINE (SHORT-STAY)—Continued
IRF–PAI Data submission
deadline for corrections of the
IRF QRP
Quarter
IRF–PAI Data collection period
Quarter 2 ....................................
Quarter 3 ....................................
Quarter 4 ....................................
January 1, 2015–March 31, 2015 .....................................................................
April 1, 2015–June 30, 2015 .............................................................................
July 1, 2015–September 30, 2015 ....................................................................
August 15, 2015.
November 15, 2015.
February 15, 2016.
* Using October 1, 2014 release of IRF–PAI.
3. Quarterly Submission Timelines of
Data Reported Using NHSN
In the FY 2014 proposed rule (78 FR
26909 through 26924), we proposed that
the IRF QRP align its deadlines for
submitting of quality data via the NHSN
with the established deadlines set forth
in the Hospital IQR and LTCHQR
Programs. We noted that the CDC
recommends that a facility report
Healthcare Acquired Infection (HAI)
events such as CAUTI as close to the
time of the event as possible, and
certainly within 30 days after the event.
We agree with the CDC’s
recommendations and therefore are
requiring that IRFs report CAUTI events,
even null events (months without
CAUTIs) within 30 days (on a monthly
level) after each event using the NHSN.
We are finalizing our proposal to
continue the calendar year basis of
reporting CAUTI, using quarterly
deadlines as established by the Hospital
IQR program for all events that occur
during each quarter. Final submission
deadlines for data collected through the
NHSN are shown in the tables below.
TABLE 15—TIMELINES FOR SUBMISSION OF IRF QRP PROGRAM QUALITY DATA USING CDC/NSHN FOR FY 2016 AND
FY 2017 IRF PPS ANNUAL INCREASE FACTOR: NATIONAL HEALTH SAFETY NETWORK (NHSN) CATHETER-ASSOCIATED URINARY TRACT INFECTION (CAUTI) OUTCOME MEASURE
Quarter
CDC/NHSN Data submission
deadline
CDC/NHSN Data collection period
FY 2016 Annual Increase Factor
Quarter
Quarter
Quarter
Quarter
1
2
3
4
....................................
....................................
....................................
....................................
January 1, 2014–March 31, 2014 .....................................................................
April 1, 2014–June 30, 2014 .............................................................................
July 1, 2014–September 30, 2014 ....................................................................
October 1, 2014–December 31, 2014 ..............................................................
August 15, 2014.
November 15, 2014.
February 15, 2015.
May 15, 2015.
FY 2017 Annual Increase Factor
Quarter
Quarter
Quarter
Quarter
1
2
3
4
....................................
....................................
....................................
....................................
January 1, 2015–March 31, 2015 .....................................................................
April 1, 2015–June 30, 2015 .............................................................................
July 1, 2015–September 30, 2015 ....................................................................
October 1, 2015–December 31, 2015 ..............................................................
Further, we proposed to apply to IRF
QRP the same deadlines established for
the reporting of the Influenza
Vaccination Coverage Among Health
Personnel (NQF #0431) measure in the
August 15, 2015.
November 15, 2015.
February 15, 2016.
May 15, 2016.
Hospital IQR Program and proposed in
the LTCH QRP.
TABLE 16—TIMELINES FOR SUBMISSION OF IRF QRP PROGRAM QUALITY DATA USING CDC/NSHN FOR FY 2016 AND
FY 2017 IRF PPS ANNUAL INCREASE FACTOR: NQF #0431 INFLUENZA VACCINATION COVERAGE AMONG
HEALTHCARE PERSONNEL
CDC/NHSN Data
submission deadline
Data collection timeframe
FY 2016 Annual Increase Factor
October 1, 2014 (or when the influenza vaccine becomes available)–March 31, 2015 ............................................................
May 15, 2015.
tkelley on DSK3SPTVN1PROD with RULES2
FY 2017 Annual Increase Factor
October 1, 2015 (or when the influenza vaccine becomes available)–March 31, 2016 ............................................................
We invited public comment on the
proposals made in the proposed rule
regarding data submission quarterly and
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
final deadlines for the purposes of
reporting data using the IRF–PAI and for
the purposes of reporting data using the
PO 00000
Frm 00060
Fmt 4701
Sfmt 4700
May 15, 2016.
NHSN. The following are comments
received in response to these proposals
and our response to these comments.
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
Comment: A few comments expressed
support for our proposal to apply
quarterly reporting deadlines to both the
measures reported using the IRF–PAI on
a fiscal year basis and to the measures
reported to the CDC via NHSN on a
calendar year basis.
Response: We thank the commenters
for their supportive comments on the
IRF–PAI measure on a fiscal year basis.
Final Decision: After careful
consideration of the public comments
we received, we are finalizing our
proposal to apply quarterly deadlines to
both the measures reported using the
IRF–PAI on a fiscal year basis and to the
measures reported to the CDC via NHSN
on a calendar year basis.
F. Reconsideration and Appeals Process
In the proposed rule (78 FR 26909
through 26921) we provided details
pertaining to a reconsideration process,
and the mechanisms related to provider
requests for reconsideration of their
annual increase factor, such as filing
requests, required content, supporting
documentation, and mechanisms of
notification and final determinations on
the IRF QRP Web site this spring at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/
index.html. We also invited public
comment on the proposed procedures
for reconsideration and appeals. We
received the following public comments
related to our discussion of the
reconsideration process in the proposed
rule:
Comment: Many commenters
expressed support of CMS’ proposed
IRF QRP reconsideration and appeals
process. Further, one commenter
encouraged CMS to mirror the processes
used in the Hospital IQR Program and
the Hospital Outpatient Quality
Reporting (OQR) Program when
developing reconsideration and appeals
and for the IRF QRP.
Response: We thank the commenters
for their support for the inclusion of
reconsideration and appeals processes
in the IRF QRP. It is our goal to align
our reconsideration and appeals process
and policies with those of existing
quality reporting programs, such as
Hospital IQR Program and the Hospital
Outpatient Quality Reporting Program,
to the extent appropriate for the IRF
QRP. We greatly appreciate the
commenters’ views on the
reconsideration process, and will
consider all of these comments for
future rulemaking and program
development.
Comment: One commenter expressed
concern that CMS did not provide
procedural details of the reconsideration
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
process through rulemaking and
encouraged CMS to ensure that
sufficient outreach and education is
conducted in a timely manner regarding
these processes.
Response: We thank the commenter
for the comments. We established a Web
site that provides procedural details for
the FY 2014 IRF QRP reconsideration
process. This information is available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/
Reconsideration-and-Disaster-WaiverRequests.html. We noted in the FY 2014
proposed rule (78 FR 26909 through
26921) that we developed this Web site
as a resource to inform providers on
how to seek reconsideration of any
decision of non-compliance for the FY
2014 annual increase factor, and the
necessary steps to do so. We provided
a process for reconsideration should
IRFs choose to avail themselves of it. In
the FY 2014 proposed rule (78 FR 26909
through 26921), we stated that IRFs
must first apply for reconsideration
through CMS prior to appealing our
initial finding of non-compliance to the
PRRB. In light of a commenter’s concern
that CMS did not provide procedural
details of the reconsideration process
through rulemaking and concern that
CMS ensure that sufficient outreach and
education are available, we have
decided to continue with an IRF QRP
reconsideration process that is
voluntary for the time being in order to
fully address these concerns. We are
therefore only recommending that IRFs
use the reconsideration process prior to
appealing to the PRRB. We note that the
agency has had good success under the
Hospital IQR program with a process
that is very similar to the one we
proposed for the IRF QR. From the
provider perspective, it allows for the
opportunity to resolve issues early in
the process when we have dedicated
resources to considering all
reconsideration requests before payment
changes are applied to an IRF’s annual
payment update. From CMS’
perspective, it decreases the number of
appeals presented to the PRRB, which
reviews cases for all quality reporting
programs, allowing for more efficient
operations at the appeals level.
Because we have been aware that
providers should be able to request a
reconsideration of their annual increase
factor if their circumstances warrant it
as soon as possible, we provided details
pertaining to the voluntary
reconsideration process, and the
mechanisms related to provider requests
for reconsiderations of their annual
increase factor, such as filing requests,
required content, supporting
PO 00000
Frm 00061
Fmt 4701
Sfmt 4700
47919
documentation, and mechanisms of
notification and final determinations on
the IRF QRP Web site in spring 2013
prior to any IRF’s need for information
on the CMS reconsideration process for
the FY 2014 annual increase factor and
subsequent years annual increase factors
at: https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting.
CMS’ subregulatory approach to the FY
2014 reconsideration process was
necessary, as any other form of the
reconsideration process that we might
propose and finalize in this rule would
not be final and in effect until October
1, 2013. This would have the effect of
proposing and finalizing a FY 2014
process for reconsiderations that should
already be completed. We note that we
are finalizing the policy that this
subregulatory approach to the
reconsideration process will remain in
effect until we can propose and finalize
a regulatory version of the
reconsideration process in future
rulemaking.
As part of the voluntary process, IRFs
that are non-compliant with the
reporting requirements during a given
reporting cycle will be notified of that
finding. The purpose of this notification
is to put the IRF on notice of the
following: (1) That the IRF has been
identified as being non-compliant with
the IRF QRP’s reporting requirements
for the reporting cycle in question; (2)
that the IRF will be scheduled to receive
a reduction in the amount of two
percentage points to the annual
payment update for the upcoming fiscal
year; (3) that the IRF may file a request
for reconsideration if they believe that
the finding of non-compliance is
erroneous, or that if they were noncompliant, they have a valid and
justifiable excuse for this noncompliance; and (4) that the IRF must
follow a defined process on how to file
a request for reconsideration, which will
be described in the notification.
Upon the conclusion of our review of
each request for reconsideration, we
will render a decision. We may reverse
our initial finding of noncompliance if:
(1) The IRF provides proof of full
compliance with all requirements
during the reporting period; or (2) the
IRF provides adequate proof of a valid
or justifiable excuse for non-compliance
if the IRF was not able to comply with
requirements during the reporting
period. We will uphold our initial
finding of noncompliance if the IRF
cannot show any justification for
noncompliance.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47920
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
G. Policy for Granting a Waiver of the
IRF QRP Data Submission Requirements
in Case of Disaster or Extraordinary
Circumstances
Our experience with other quality
reporting programs has shown that there
are times when providers are unable to
submit quality data due to the
occurrence of extraordinary
circumstances beyond their control (for
example, natural or man-made
disasters). We define 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 or impact multiple
structures or be isolated and impact a
single site only.
In certain instances of either natural
or man-made disasters, an IRF may have
the ability to conduct a full patient
assessment, and record and save the
associated data either during or before
the occurrence of an extraordinary
event. In this case, the extraordinary
event has not caused the facility’s data
files to be destroyed, but it could hinder
the IRF’s ability to meet the quality
reporting program’s data submission
deadlines. In this scenario, the IRF
would potentially have the ability to
report the data at a later date, after the
emergency circumstances have
subsided. In such cases, a temporary
waiver of the IRF duty to report quality
measure data may be appropriate.
In other circumstances of natural or
man-made disaster, an IRF may not have
had the ability to conduct a full patient
assessment, and record and save the
associated data before the occurrence of
an extraordinary event. In such a
scenario, the facility does not have data
to submit to CMS as a result of the
extraordinary event. We believe that it
is appropriate, in these situations, to
grant a full waiver of the reporting
requirements.
It is our goal not to penalize IRF
providers in these circumstances or to
unduly increase their burden during
these times. Therefore, we proposed a
process, for payment year 2015 and
subsequent years, for IRF providers to
request and for us to grant waivers with
respect to the reporting of quality data
when there are extraordinary
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
circumstances beyond the control of the
provider. When a waiver is granted, an
IRF will not incur payment reduction
penalties for failure to comply with the
requirements of the IRF QRP.
In the FY 2014 proposed rule (78 FR
26909 through 26921), we proposed to
establish a disaster waiver process, in
which IRFs that have experienced a
disaster can request a waiver of their
quality reporting responsibilities for
purposes of payment year 2015 and
subsequent payment years. We
proposed that the IRF may request a
waiver for one or more quarters by
submitting a written request to CMS. We
also proposed that should IRFs compose
a letter to CMS that documents the
waiver request, with the information
described below, and submit the letter
to CMS via email to the IRF Help Desk
at IRFQRPReconsiderations@
cms.hhs.gov. IRFs that have filed a
request for an IRF QRP disaster waiver
with an IRF–PAI waiver request using
the procedure that is described under
our regulations at 42 CFR § 412.614 can
indicate this in their letter to CMS for
their request for a waiver for quality
reporting purposes.26
Note that the subject of the email
must read ‘‘Disaster Waiver Request’’
and the letter must contain the
following information:
• IRF CCN;
• IRF 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);
• IRF’s reason for requesting a waiver;
• Evidence of the impact of
extraordinary circumstances, including
but not limited to photographs,
newspaper and other media articles; and
• A date when the IRF believes that
it will again be able to submit IRF QRP
data and a justification for the proposed
date.
We proposed that the letter
documenting the disaster waiver request
be signed by the IRF’s CEO, and must
be submitted within 30 days of the date
that the extraordinary circumstances
occurred. Following receipt of the letter,
we would: (1) Provide a written
acknowledgement, using the contact
information provided in the letter, to the
CEO or designated contact person,
notifying them that the request has been
received, and (2) after CMS has made a
decision as to whether to grant the
waiver request, provide a formal
response to the CEO, or designated
26 https://www.gpo.gov/fdsys/pkg/CFR-2011title42-vol2/pdf/CFR-2011-title42-vol2-sec412614.pdf.
PO 00000
Frm 00062
Fmt 4701
Sfmt 4700
contact person notifying them of our
decision.
This policy does not preclude us from
granting waivers to IRFs 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 a waiver to IRFs in a region or
locale, we propose to communicate this
decision through routine
communication channels to IRFs and
vendors, including but not limited to
issuing memos, emails, and notices on
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/
index.html.
In the proposed rule, we invited
public comment on our proposed
disaster waiver process. A summary of
the public comments received and our
responses to comments are discussed
below.
Comment: Several commenters stated
that they support the IRF QRP disaster
waiver policy and ‘‘applaud the agency
for recognizing the impact of natural
disasters and other extenuating
circumstances on the ability of IRFs to
collect and report quality data.’’
Response: We appreciate the
commenters’ support and recognition of
our efforts to plan for various types of
emergency situations that can impact an
IRF’s ability to report quality data.
Final Decision: After careful
consideration of the public comments
received, we are finalizing the IRF QRP
disaster/extraordinary circumstances
waiver and appeals processes as
proposed.
H. Public Display of Data Quality
Measures for the IRF QRP Program
Under section 1886(j)(7)(E) of the Act,
the Secretary is required to establish
procedures for making data submitted
under the IRF QRP available to the
public. Section 1886(j)(7)(E) of the Act
also requires procedures to ensure that
each IRF provider has the opportunity
to review the data that is to be made
public with respect to its facility, prior
to such data being made public. Section
1886(j)(7)(E) of the Act requires CMS to
report quality measures that relate to
services furnished in IRFs on CMS’ Web
site.
Currently, the Agency is developing
plans regarding the implementation of
these provisions. We appreciate the
need for transparency in the processes
and procedures that will be
implemented to allow for the public
reporting of the IRF QRP data and to
afford providers the opportunity to
preview that data before it is made
public. At this time, we have not
E:\FR\FM\06AUR2.SGM
06AUR2
47921
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
established procedures or timelines for
public reporting of data, but we intend
to include related proposals in future
rule making.
Comment: Several commenters urged
CMS to convene stakeholders to inform
this process prior to rulemaking. One
commenter strongly encouraged CMS to
display the most current performance
data for public reporting of IRF QRP
data.
Response: We appreciate the
commenters for their feedback. We
appreciate the need to ensure that the
data made publicly available is easily
understood by all stakeholders,
including providers and consumers. At
this time, we are working to establish
procedures for public reporting,
including procedures that provide the
opportunity for IRFs to review their data
before it is made public, and will
propose such procedures through future
rulemaking after allowing stakeholders
the opportunity to submit input.
We thank the commenters for the
input and suggestions, and we will
consider them as we develop proposals
for public reporting of quality measures
in future rulemaking.
I. Method for Applying the Reduction to
the FY 2014 IRF Increase Factor for IRFs
That Fail To Meet the Quality Reporting
Requirements
As previously noted, section
1886(j)(7)(A)(i) of the Act requires
application of a 2 percentage point
reduction of the applicable market
basket increase factor for IRFs that fail
to comply with the quality data
submission requirements. FY 2014 is to
be the first year that the mandated
reduction will be applied for IRFs that
failed to comply with the data
submission requirements during the
data collection period October 1, 2012
through December 31, 2012. Thus, in
compliance with 1886(j)(7)(A)(i) of the
Act, we will apply a 2 percentage point
reduction to the applicable FY 2014
market basket increase factor (1.8
percent) in calculating an adjusted FY
2014 standard payment conversion
factor to apply to payments for only
those IRFs that failed to comply with
the data submission requirements. As
noted previously, application of the 2
percentage point reduction may result
in an update that is less than 0.0 for a
fiscal year and in payment rates for a
fiscal year being less than such payment
rates for the preceding fiscal year. Also,
reporting-based reductions to the market
basket increase factor will not be
cumulative; they will only apply for the
FY involved. Table 17 shows the
calculation of the adjusted FY 2014
standard payment conversion factor that
will be used to compute IRF PPS
payment rates for any IRF that failed to
meet the quality reporting requirements
for the period from October 1, 2012
through December 31, 2012.
TABLE 17—CALCULATIONS TO DETERMINE THE ADJUSTED FY 2014 STANDARD PAYMENT CONVERSION FACTOR FOR
IRFS THAT FAILED TO MEET THE QUALITY REPORTING REQUIREMENT
Explanation for Adjustment
Calculations
Standard Payment Conversion Factor for FY 2013 ........................................................................................................................
Adjusted Market Basket Increase Factor for FY 2014 (2.6 percent), reduced by 0.3 percentage point in accordance with sections 1886(j)(3)(C) and (D) of the Act and a 0.5 percentage point reduction for the productivity adjustment as required by
section 1886(j)(3)(C)(ii)(I) of the Act, further reduced by 2 percentage points for IRFs that failed to meet the quality reporting requirement ............................................................................................................................................................................
Budget Neutrality Factor for the Wage Index and Labor-Related Share ........................................................................................
Budget Neutrality Factor for the Revisions to the CMG Relative Weights .....................................................................................
Budget Neutrality Factor for the Update to the Rural Adjustment Factor .......................................................................................
Budget Neutrality Factor for the Update to the LIP Adjustment Factor ..........................................................................................
Budget Neutrality Factor for the Update to the Teaching Status Adjustment Factor .....................................................................
Adjusted FY 2014 Standard Payment Conversion Factor ..............................................................................................................
tkelley on DSK3SPTVN1PROD with RULES2
XV. Miscellaneous Comments
Comment: Several commenters
requested that CMS use the most recent
three years of data and the first year of
data collected under ICD–10 to review
and update the list of comorbidities
used to determine the tier payments to
ensure that the tier list reflects all
conditions that contribute significantly
to IRF costs of care. One commenter also
suggested that CMS re-examine the
omission from this list of certain
comorbidities that are considered
preventable and might lead to perverse
incentives for the IRF to undertreat
these conditions.
Response: We appreciate the
commenters’ suggestions, and will
consider these suggestions for future
analyses.
Comment: One commenter suggested
that CMS revise the IRF coverage
requirements that are described in
chapter 1, section 110 of the Medicare
Benefit Policy Manual (Pub. L. 100–02)
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
to allow recreational therapy services to
count, on a limited basis, towards the
intensive rehabilitation therapy
requirement in IRFs when the medical
necessity is well-documented by the
rehabilitation physician in the medical
record and is ordered by the
rehabilitation physician as part of the
overall plan of care for the patient.
Response: As we did not propose any
changes to the IRF coverage
requirements in § 412.622(a)(3), (4), and
(5) that would affect any of the
requirements described in chapter 1,
section 110 of the Medicare Benefit
Policy Manual (Pub. L. 100–02), this
comment is outside the scope of the
proposed rule. However, as we have
indicated previously in the FY 2012 IRF
PPS final rule (76 FR 47836 at 47883),
we do not believe that recreational
therapy services should replace the
provision of the 4 core skilled therapy
services (physical therapy, occupational
therapy, speech-language therapy, and
prosthetics/orthotics). Thus, we believe
PO 00000
Frm 00063
Fmt 4701
Sfmt 4700
$14,343
×
×
×
×
×
×
=
0.99800
1.0010
1.0000
1.0025
1.0171
0.9962
$14,555
it should be left to each individual IRF
to determine whether offering
recreational therapy is the best way to
achieve the desired patient care
outcomes. As we have stated previously,
recreational therapy is a covered service
in IRFs when the medical necessity is
well-documented by the rehabilitation
physician in the medical record and is
ordered by the rehabilitation physician
as part of the overall plan of care for the
patient. Recreational therapy may be
offered as an additional service above
and beyond the core skilled therapy
services used to demonstrate the
provision of an intensive rehabilitation
therapy program, but may not replace
one of these therapies.
Comment: One commenter requested
that we consider a new model of
payment for post-acute care services,
such as the Continuing Care Hospital
(CCH) model, that would pay based on
the needs of the patient rather than the
setting in which the care is provided.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47922
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
This commenter urged us to pilot test
the CCH idea.
Response: As we did not propose any
new payment models for post-acute care
services in the FY 2014 IRF PPS
proposed rule (78 FR 26880), this
comment is outside the scope of this
rule. However, we appreciate the
commenter’s suggestions, and we note
that on May 15, 2013, CMS announced
a second round of Health Care
Innovation Awards. Under this
announcement, we will spend up to $1
billion for awards and evaluation of
projects from across the country that test
new payment and service delivery
models that will deliver better care and
lower costs for Medicare, Medicaid, and
Children’s Health Insurance Program
(CHIP) enrollees. In addition, we
commenced the Bundled Payments for
Care Improvement Initiative, whereby
organizations will enter into payment
arrangements that include financial and
performance accountability for episodes
of care. These models may lead to
higher quality, more coordinated care at
a lower cost to Medicare. In one of the
model designs being tested (referred to
as ‘‘Model 3’’ at https://
innovation.cms.gov/initiatives/BPCIModel-3), the episode of care will be
triggered by an acute care hospital stay
and will begin at initiation of post-acute
care services with a participating skilled
nursing facility, inpatient rehabilitation
facility, long-term care hospital or home
health agency.
Comment: Several commenters
requested that we use the electronic
signature guidelines provided in the
Medicare Program Integrity Manual to
allow the use of electronic signatures for
all required documentation, including
for the rehabilitation physician’s review
and concurrence with the preadmission
screening requirements under the IRF
coverage requirements in
412.622(a)(3)(i).
Response: As we did not propose any
changes to the regulations in
§ 412.622(a)(3)(i) in the May 8, 2013
proposed rule (78 FR 26880), this
comment in outside the scope of this
final rule. However, we have provided
specific guidance on the use of
electronic signatures for documentation
of the rehabilitation physician’s review
and concurrence with the IRF
preadmission screening requirements,
which can be downloaded from the IRF
PPS Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/
Downloads/ElecSysClar.pdf.
XVI. Provisions of the Final Regulations
In this final rule, we are adopting the
provisions set forth in the FY 2014 IRF
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
PPS proposed rule (78 FR 26880),
except as noted elsewhere in the
preamble. Specifically:
A. Payment Provision Changes
• We will update the FY 2014 IRF
PPS relative weights and average length
of stay values using the most current
and complete Medicare claims and cost
report data in a budget-neutral manner,
as discussed in section IV of this final
rule.
• We will update the FY 2014 IRF
PPS facility-level adjustment factors,
using the most current and complete
Medicare claims and cost report data
with an enhanced estimation
methodology, in a budget-neutral
manner, as discussed in section V of
this final rule.
• We will update the FY 2014 IRF
PPS payment rates by the market basket
increase factor, based upon the most
current data available, with a 0.3
percentage point reduction as required
by sections 1886(j)(3)(C)(ii)(II) and
1886(j)(3)(D)(iii) of the Act and a
productivity adjustment required by
section 1886(j)(3)(C)(ii)(I) of the Act, as
described in section VI of this final rule.
• We will indicate the Secretary’s
Final Recommendation for updating IRF
PPS payments for FY 2014, in
accordance with the statutory
requirements, as described in section VI
of this final rule.
• We will update the FY 2014 IRF
PPS payment rates by the FY 2014 wage
index and the labor-related share in a
budget-neutral manner, as discussed in
section VI of this final rule.
• We will calculate the final IRF
Standard Payment Conversion Factor for
FY 2014, as discussed in section VI of
this final rule.
• We will update the outlier
threshold amount for FY 2014, as
discussed in section VII of this final
rule.
• We will update the cost-to-charge
ratio (CCR) ceiling and urban/rural
average CCRs for FY 2014, as discussed
in section VII of this final rule.
• We will adopt revisions to the list
of eligible ICD–9–CM diagnosis codes
that meet the presumptive compliance
criteria, with a one-year delayed
implementation date, as discussed in
section VIII of this final rule.
• We will adopt non-quality-related
revisions to IRF–PAI sections effective
October 1, 2014, as discussed in section
IX of this final rule.
• We will adopt revisions and
updates to quality measures and
reporting requirements under the
quality reporting program for IRFs in
accordance with section 1886(j)(7) of the
Act, effective October 1, 2014, as
PO 00000
Frm 00064
Fmt 4701
Sfmt 4700
discussed in section XIV of this final
rule.
B. Revisions to Existing Regulation Text
In this final rule, we will make the
following revisions to the existing
regulations:
• We will revise § 412.25(a)(1)(iii) to
specify a minimum required number of
beds that are not excluded from the
inpatient prospective payment system
(IPPS) for a hospital that has an IRF
unit, with a one-year delayed
implementation date to give providers
an opportunity to comply with the
requirements, as described in section XI
of this final rule.
• We will make technical corrections
to § 412.130, to reflect prior changes to
the regulations at § 412.29 and § 412.30
that we made in the FY 2012 IRF PPS
final rule (76 FR 47836), as described in
section X of this final rule.
• We will make clarifications to
§ 412.630, to reflect the scope of section
1886(j)(8) of the Act, as described in
section XII of this final rule.
• We will revise § 412.29(d), to clarify
that Medicare requires the rehabilitation
physician’s review and concurrence on
the preadmission screening for
Medicare Part A Fee-for-Service patients
only, as described in section XIII of this
final rule.
XVII. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 30day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. To fairly evaluate whether an
information collection should be
approved by OMB, section 3506(c)(2)(A)
of the Paperwork Reduction Act of 1995
requires that we solicit comment on the
following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
This final rule does not impose any
new information collection
requirements as outlined in the
regulation text. However, this final rule
does make reference to associated
information collections that are not
discussed in the regulation text
contained in this document. The
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
following is a discussion of these
information collections, some of which
have already received OMB approval.
A. ICRs Regarding IRF QRP
As stated in section XIV. of this final
rule, we are adopting one new measure
for use in the IRF QRP which will affect
the increase factor for FY 2016. This
quality measure is: Influenza
Vaccination Coverage among Healthcare
Personnel (NQF #0431). We are also
adopting 2 new measures that will affect
the increase factor for FY 2017. The first
is an All-Cause Unplanned Readmission
Measure for 30 Days Post Discharge
from Inpatient Rehabilitation Facilities.
This measure is a claims-based measure
that does not require submission of data
by IRF providers. In addition, we are
adopting the Percent of Residents or
Patients Who Were Assessed and
Appropriately Given the Seasonal
Influenza Vaccine (Short-Stay) (NQF
#0680) measure. Finally, we are
replacing a non-risk adjusted
application of an NQF-endorsed
pressure ulcer measure, in which only
numerator and denominator data is
collected, to use the NQF-endorsed
version of this measure ‘‘Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short-Stay)’’ (NQF #0678), which is a
risk-adjusted measure. Each of these
measures will be collected in the
manner described below:
tkelley on DSK3SPTVN1PROD with RULES2
1. Influenza Vaccination Coverage
Among Healthcare Personnel (NQF
#0431)
In section XIV. of this final rule, we
are adopting the new measure, Influenza
Vaccination Coverage among Healthcare
Personnel (NQF #0431) to the IRF QRP.
IRFs will be required to collect data
related to the number of healthcare
personnel working at a facility who
have been vaccinated against the
influenza virus during a given influenza
vaccination season. The CDC has
determined that the influenza
vaccination season begins on October
1st (or when the vaccine becomes
available) and ends on the following
March 31st each year. This measure
requires that the provider submit only
one report to NHSN by the data
submission deadline of May 15
following the close of the data collection
period each year.
It has become a common practice for
healthcare facilities, including IRFs, to
promote vaccination of employees for
the influenza virus and to keep records
of which of their staff members received
this vaccination each year. Therefore,
we do not believe that IRFs will incur
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
any additional burden related to the
collection of the data for this measure.
We anticipate that it will take
approximately 15 minutes to prepare
and transmit the required data for this
measure to the CDC each year. The
reporting of the data for this measure
can be done while the provider is logged
onto NHSN for the purpose of entering
their CAUTI measure data. We believe
that this task can be completed by an
administrative person such as a Medical
Secretary/Medical Data Entry Clerk. The
average hourly wage for Medical
Records or Health Information
Technicians is $15.55.27 We estimate
that the annual cost to each IRF for the
reporting of the staff influenza measure
will be $3.89.28 The annual cost across
the 1161 IRFs in the U.S. that are
reporting data to CMS is estimated to be
$4,516.29
2. All-Cause Unplanned Readmission
Measure for 30 Days Post Discharge
from Inpatient Rehabilitation Facilities
As stated in section XIV. of this final
rule, data for this measure will be
collected from Medicare claims and
therefore will not add any additional
reporting burden for IRFs.
3. Percent of Residents or Patients with
Pressure Ulcers that are New or Have
Worsened (Short-Stay) (NQF #0678)
In section XIV of this final rule, we
are adopting the NQF-endorsed version
of the measure titled ‘‘Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short-Stay)’’ (NQF #0678), affecting the
FY 2017 annual increase factor. To
support the standardized collection and
calculation of this quality measure, we
are modifying the current Inpatient
Rehabilitation Facility-Patient
Assessment Instrument (IRF–PAI) by
replacing the current pressure ulcer
items with data elements similar or
identical to those collected through the
Minimum Data Set 3.0 (MDS 3.0) used
in nursing homes. By building upon
preexisting resources, we intend to
reduce administrative burden related to
data collection and submission. We
anticipate that the initial setup and
acclimation to pressure ulcer data
collection will have already occurred
27 According to the U.S. Bureau of Labor
Statistics, the mean hourly wage for a Medical
Records & Health Information Technician is $15.55.
See: https://www.bls.gov/ooh/healthcare/medicalrecords-and-health-information-technicians.htm.
28 15 minutes Administrative staff time to collect
and report staff influenza measure @ $15.55 per
hour = $3.9889 per IRF per year.
29 At the time of the writing of this rule, there
were 1161 IRFs reporting quality data to CMS.
($3.9889 per IRF per year × 1161 IRFs in U.S. =
$4,621516).
PO 00000
Frm 00065
Fmt 4701
Sfmt 4700
47923
with the adoption of the pressure ulcer
measure for the IRF QRP for the FY
2014 annual increase factor. Therefore,
we believe the transition to reporting
similar as well as additional data
elements for this measure will be less
burdensome.
We expect that the admission and
discharge pressure ulcer data will be
collected by a clinician such as an RN
because the assessment and staging of
pressure ulcers requires a high degree of
clinical judgment and experience. We
estimate that it will take approximately
10 minutes of time by the RN to perform
the admission pressure ulcer
assessment. We further estimate that it
will take an additional 15 minutes of
time to complete the discharge pressure
ulcer assessment. We expect that during
these time periods, the RN would be
engaged in the collection of data for the
purpose of the IRF QRP and would not
be engaged in the performance of
routine patient care.
We estimate that there are 359,000
IRF–PAI submissions per year 30 and
that there are 1161 IRFs in the U.S.
reporting quality data to CMS. Based on
these figures, we estimate that each IRF
will submit approximately 309 IRF–
PAIs per year or 26 IRF–PAIs per
month.31 Assuming that each IRF–PAI
submission requires 25 minutes of time
by an RN at an average hourly wage of
$33.23,32 the yearly cost to each IRF
would be $4,278.36 33 and the
annualized cost across all IRFs would be
$4,967,176.34
We also expect that most IRFs will
use administrative personnel, such as a
medical secretary or medical data entry
clerk, to perform the task of entering the
IRF–PAI pressure ulcer assessment data
into their electronic health record (EHR)
system and/or the CMS JIRVEN
program. We estimate that this data
entry task will take no more than 3
minutes for each IRF–PAI record or
15.45 hours for each IRF annually or
30 MedPAC, A Data Book: Health Care Spending
and the Medicare Program (June 2012), https://
www.medpac.gov/chapters/
Jun12DataBookSec8.pdf.
31 359,000 IRF–PAIs per all IRFs per year/1161
IRFs in U.S. = 309 IRF–PAIs per each IRF per year.
309 IRF–PAI reports per IRF per year/12 months
per year = 26 IRF–PAI reports per each IRF per year.
32 According to the U.S. Bureau of Labor
Statistics, the mean hourly wage for a Registered
Nurse is $33.23. (See https://www.bls.gov/oes/2011/
may/oes291111.htm).
33 25 minutes × 309 IRF–PAI assessments per
each IRF per year = 7,725 minutes per each IRF per
year.
7,725 minutes per each IRF per year/60 minutes
per hour = 128.75 hours per each IRF per year.
128.75 hours per year × $33.23 per hour =
$4,278.36 nursing wages per each IRF per year.
34 $4,278.36 × 1161 IRF providers = $4,967,176
per all IRFs per year.
E:\FR\FM\06AUR2.SGM
06AUR2
47924
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
17,937 hours across all IRFs. As noted
above, the average hourly wage for a
Medical Records & Health Information
Technician is $15.55. As we noted
above, there are approximately 359,000
IRF–PAI submissions per year and 1161
IRFs reporting quality data to CMS.
Given this wage information, the
estimated total annual cost across all
reporting IRFs for the time required for
entry of pressure ulcer data into the
IRF–PAI record is $278,930. We further
estimate the average yearly cost to each
individual IRF to be $240.25.
We estimate that the combined
annualized time burden related to the
pressure ulcer data item set for work
performed, by the both clinical and
administrative staff will be 144.20 hours
for each individual IRF and 167,416
hours across all IRFs. The total
estimated annualized cost for collection
and submission of pressure ulcer data is
$4,518.61 for each IRF and $5,246,106
across all IRFs. We estimate the cost for
each pressure ulcer submission to be
$14.61.
4. Percent of Residents or Patients Who
Were Assessed and Appropriately Given
the Seasonal Influenza Vaccine (ShortStay) (NQF #0680)
In section XIV. of this final rule, we
are adding the measure, Percent of
Residents or Patients Who Were
Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay)
(NQF #0680) to the IRF QRP. We further
are adding a new set of standardized
data elements now used in the MDS 3.0
to the IRF–PAI to collect the data
required for this measure.
IRFs are already required to complete
and transmit certain IRF–PAI data on all
Medicare Part A Fee-for-Service and
Medicare Part C (Medicare Advantage)
patients to receive payment from
Medicare. By building upon preexisting
resources, we intend to reduce
administrative burden related to data
collection and submission. We
anticipate that the initial setup and
acclimation to data collection through
the IRF–PAI for purposes of reporting
IRF quality measure data will have
already occurred with the adoption of
the Pressure Ulcer measure for the IRF
QRP for the FY 2014 increase factor.
Therefore, we believe the transition to
reporting an additional measure via the
IRF–PAI may be less burdensome.
We estimate that completion of the
patient influenza measure item set will
take approximately 5 minutes to
complete. The patient influenza item set
consists of three items (questions). Each
item is straightforward and does not
require physical assessment for
completion. We estimate that it will take
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
approximately 0.7 minutes to complete
each item, or 2.1 minutes to complete
the entire item set. However, in some
cases, the person completing this item
set may need to consult the patient’s
medical record to obtain data about the
patient’s influenza vaccination.
Therefore, we have allotted 1.6 minutes
per item or a total of 5 minutes to
complete the item set.
The IRF staff will be required to
perform a full influenza assessment only
during the influenza vaccination season.
The CDC defines that influenza
vaccination season as the time period
from October 1st (or when the vaccine
becomes available) through March 31
each year. From April 1st through
September 30th, IRFs are not required to
perform full influenza screening and
may skip to the next item set after
checking the selection which indicates
that the patient’s IRF stay occurred
outside of the influenza vaccination
season. Our time estimate reflects the
averaged amount of time necessary to
complete the influenza item set both
during and outside the influenza
vaccination season.
We anticipate that the patient
influenza item set will be completed by
a clinician such an RN, while
completing the Quality Indicator section
of the IRF–PAI. It is most appropriate
for an RN to complete the influenza
item set because it involves performing
a skilled assessment to determine, from
a patient’s records, whether the patient
has received a vaccination and, if not,
to discuss with the patient any
medications or other related topics such
as medication allergies, other
vaccinations that the patient may have
had, and any contraindications that
might exist for receiving the influenza
vaccination. The nurse has knowledge
and experience to determine the
relevance of this information to the
patient influenza items and also to
determine if the patient should be given
the influenza vaccination.
As noted above, we estimate that it
will take approximately 5 minutes to
complete the patient influenza measure
item set. We have also noted above that
there are approximately 359,000 IRF–
PAIs completed annually across all 1161
IRFs that report IRF quality data to
CMS. This breaks down to
approximately 309 IRF–PAIs completed
by each IRF yearly.35 We estimate that
the annual time burden for reporting the
patient influenza vaccination measure
data is 29,896 hours across all IRFs in
the U.S. and 26 hours for each
35 359,000 IRF–PAI reports per all IRFs per year/
1161 IRFs in U.S. = 309 IRF–PAI reports per each
IRF per year.
PO 00000
Frm 00066
Fmt 4701
Sfmt 4700
individual IRF. According to the U.S.
Bureau of Labor, the hourly wage for a
Registered Nurse is $33.23. Taking all of
the above information into
consideration, we estimate the annual
cost across all IRFs for the submission
of the patient influenza measure data to
be $993,433. We further estimate the
cost for each individual IRF to be
$855.67. A summary of the public
comments received on our burden
estimate for this measure and our
responses to those comments are
discussed below.
Comment: The additional burden of
data collection (that is, seeking
information directly from the patient or
by searching through the paper medical
record) must not take away from limited
resources in these facilities which are
needed to provide direct care.
Response: We agree that there will be
some additional burden added because
IRFs will be required to check to see if
the patient received the influenza
vaccination prior to admission to the
IRF. However, we believe that the
burden will be minimal.
Most patients are transferred to IRFs
from an acute care facility. If the patient
received the influenza vaccination
while in the acute care facility, there
should be several places where the
information about the administration of
this vaccination can be quickly and
easily located. The influenza
vaccination is a medication, so the
Medication Administration Record
would be one place that this
information could be located. Also, if
this vaccination was ordered by a
physician or the acute care facility had
standing orders for the administration of
the vaccination, then the Physicians
Order section of the chart is another
place that is likely to contain the
influenza vaccination information.
Comment: One commenter suggested
that CMS’ estimates on the burden
caused by the implementation of the
two vaccination measures (Influenza
Vaccination Coverage among Healthcare
Personnel (NQF #0431) and Percent of
Residents or Patients Who Were
Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay)
(NQF#0680) are inaccurate because they
do not encompass changes that must be
made to its billing software, electronic
medical records, or administrative
processes.
Response: When making a burden
estimate, we estimate only those
activities and costs that are common to
a majority of providers and which can
be fairly and accurately estimated across
all IRFs. Unfortunately, costs related to
changes to billing and electronic
medical record software, or
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
administrative processes are costs that
are so variable among different IRFs we
are not able to make an accurate
estimate of these costs that can be
applied across all providers.
Costs for updates to electronic
medical records are extremely variable
and will depend on many factors such
as the manufacturer of the electronic
medical records software; whether there
is a warranty that covers updates;
whether the IRF has a service contract
which covers updates; who the IRF
hires to perform upgrades to its system;
where the IRF is geographically located;
or whether the cost is incurred by a
large corporation that owns many IRFs
or the IRF is a solely owned and
operated facility. In regard to costs for
changes to administrative processes,
these costs are also difficult to define or
quantify as they are equally variable, if
not more so than costs related to
changes to electronic record systems.
Even though it was not reflected in
the burden estimate, CMS does
recognize that many IRFs will incur
costs for changes that will be required
to billing software, electronic medical
records, or administrative processes.
Some of these changes are required as
a result of the IRF QRP proposals that
we are finalizing in this final rule.
However, we believe that some of these
costs are also attributable to non-quality
related proposals that are being
finalized in this rule.
the IRF–PAI would decrease the total
estimated burden of completing the
non-quality related portions of the IRF–
PAI by 3 minutes. However, we estimate
that it will take about 3 minutes to
complete the new non-quality related
items that we are proposing to add.
Therefore, we estimate no net change in
the amount of time associated with
completing the non-quality related
portions of the IRF–PAI and that the
burden for completing these portions of
the IRF–PAI will not change.
We did not receive any comments
specifically on the information
collection requirements regarding the
non-quality related changes to the IRF–
PAI.
We will be submitting a revision to
the current IRF–PAI collection of
information approval under (OMB
control number 0938–0842) for OMB
review and approval.
If you comment on these information
collection and recordkeeping
requirements, please do either of the
following:
1. Submit your comments
electronically as specified in the
ADDRESSES section of the proposed rule;
or
2. Submit your comments to the
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: CMS Desk Officer,
CMS–1448–P, Fax: (202) 395–6974; or,
Email: OIRA_submission@omb.eop.gov.
B. ICRs Regarding Non-Quality Related
Changes to the IRF–PAI
We will revise several items on the
IRF–PAI to provide greater clarity for
providers. The changes include
updating several items regarding the
response options available to providers.
Additionally, we are removing several
items that we believe are unnecessary
for providers to continue documenting
on the IRF–PAI since those items are
already being documented in the
patients’ medical record. We are also
adding several items, such as a signature
page, to fulfill providers’ request to have
an organized way to document who has
assessed the patient and when that
assessment took place. We do not
estimate any additional burden for IRFs
to complete the IRF–PAI as a result of
these changes. We estimate the time that
will be needed to complete the new
non-quality related proposed items,
equals the time that was needed to
complete the previous non-quality
related items. When the original burden
estimates were completed for the IRF–
PAI, we estimated that the proposed
deletion of the non-quality related items
would take approximately 3 minutes to
complete. Thus, removing these items
XVIII. Regulatory Impact Analysis
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
A. Statement of Need
This final rule updates the IRF
prospective payment rates for FY 2014
as required under section 1886(j)(3)(C)
of the Act. It responds to section
1886(j)(5) of the Act, which requires the
Secretary to publish in the Federal
Register on or before the August 1 that
precedes the start of each fiscal year, the
classification and weighting factors for
the IRF PPS’s case-mix groups and a
description of the methodology and data
used in computing the prospective
payment rates for that fiscal year.
This rule implements sections
1886(j)(3)(C) and (D) of the Act. Section
1886(j)(3)(C)(ii)(I) of the Act requires the
Secretary to apply a multi-factor
productivity adjustment to the market
basket increase factor, and to apply
other adjustments as defined by the Act.
The productivity adjustment applies to
FYs from 2012 forward. The other
adjustments apply to FYs 2010 through
2019.
This rule also adopts some policy
changes within the statutory discretion
afforded to the Secretary under section
1886(j) of the Act. We will revise the list
PO 00000
Frm 00067
Fmt 4701
Sfmt 4700
47925
of diagnosis codes that are eligible
under the presumptive compliance
method of calculating an IRF’s
compliance percentage under the ‘‘60
percent rule’’ effective for compliance
review periods beginning on or after
October 1, 2014 (a one-year delay),
update the IRF facility-level adjustment
factors, revise sections of the Inpatient
Rehabilitation Facility-Patient
Assessment Instrument, revise
requirements for acute care hospitals
that have IRF units beginning on or after
October 1, 2014 (a one-year delay),
clarify the IRF regulation text regarding
limitation of review, and revise and
update quality measures under the IRF
quality reporting program. We believe
that the policy changes will enhance the
clarity, accuracy, and fairness of the IRF
PPS.
B. Overall Impacts
We have examined the impacts of this
final rule as required by Executive
Order 12866 (September 30, 1993,
Regulatory Planning and Review),
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011), the Regulatory
Flexibility Act (September 19, 1980,
Pub. L. 96–354) (RFA), section 1102(b)
of the Act, section 202 of the Unfunded
Mandates Reform Act of 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
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. A
regulatory impact analysis (RIA) must
be prepared for a major final rule with
economically significant effects ($100
million or more in any one year). We
estimate the total impact of the policy
updates described in this final rule by
comparing the estimated payments in
FY 2014 with those in FY 2013. This
analysis results in an estimated $170
million increase for FY 2014 IRF PPS
payments. As a result, this final rule is
designated as economically
‘‘significant’’ under section 3(f)(1) of
Executive Order 12866, and hence a
major rule under the Congressional
Review Act. Also, the rule has been
reviewed by OMB.
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47926
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
The Regulatory Flexibility Act (RFA)
requires agencies to analyze options for
regulatory relief of small entities, if a
rule has a significant impact on a
substantial number of small entities. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and small governmental
jurisdictions. Most IRFs and most other
providers and suppliers are small
entities, either by having revenues of $7
million to $34.5 million or less in any
1 year depending on industry
classification, or by being nonprofit
organizations that are not dominant in
their markets. (For details, see the Small
Business Administration’s final rule that
set forth size standards for health care
industries, at 65 FR 69432 at https://
www.sba.gov/sites/default/files/files/
Size_Standards_Table.pdf, effective
March 26, 2012.) Because we lack data
on individual hospital receipts, we
cannot determine the number of small
proprietary IRFs or the proportion of
IRFs’ revenue that is derived from
Medicare payments. Therefore, we
assume that all IRFs (an approximate
total of 1,100 IRFs, of which
approximately 60 percent are nonprofit
facilities) are considered small entities
and that Medicare payment constitutes
the majority of their revenues. The
Department of Health and Human
Services generally uses a revenue
impact of 3 to 5 percent as a significance
threshold under the RFA. As shown in
Table 18, we estimate that the net
revenue impact of this final rule on all
IRFs is to increase estimated payments
by approximately 2.3 percent. However,
we find that certain categories of IRF
providers would be expected to
experience revenue impacts in the 3 to
5 percent range. We estimate a 5.0
percent overall impact for teaching IRFs
with resident to average daily census
ratios of 10 to 19 percent, a 10.1 percent
overall impact for teaching IRFs with a
resident to average daily census ratio
greater than 19 percent, and a 4.1
percent overall impact for IRFs with a
DSH patient percentage of 0 percent. As
a result, we anticipate this final rule
adoptes a net positive impact on a
substantial number of small entities.
Medicare fiscal intermediaries,
Medicare Administrative Contractors,
and carriers are not considered to be
small entities. Individuals and States are
not included in the definition of a small
entity.
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
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
the provisions of section 603 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area and has
fewer than 100 beds. As discussed in
detail below, the rates and policies set
forth in this final rule will not have a
significant impact (not greater than 3
percent) on rural hospitals based on the
data of the 167 rural units and 18 rural
hospitals in our database of 1,134 IRFs
for which data were available.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–04, enacted on March 22, 1995)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any one year of
$100 million in 1995 dollars, updated
annually for inflation. In 2013, that
threshold level is approximately $141
million. This final rule will not impose
spending costs on State, local, or tribal
governments, in the aggregate, or by the
private sector, of greater than $141
million.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a final
rule that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has federalism implications.
As stated above, this final rule will not
have a substantial effect on State and
local governments, preempt state law, or
otherwise have a federalism
implication.
C. Detailed Economic Analysis
1. Basis and Methodology of Estimates
This final rule sets forth policy
changes and updates to the IRF PPS
rates contained in the FY 2013 notice
(77 FR 44618). Specifically, this final
rule updates the CMG relative weights
and average length of stay values, the
facility-level adjustment factors, the
wage index, and the outlier threshold
for high-cost cases. This final rule also
applies a MFP adjustment to the FY
2014 RPL market basket increase factor
in accordance with section
1886(j)(3)(C)(ii)(I) of the Act, and a 0.3
percentage point reduction to the FY
2014 RPL market basket increase factor
in accordance with sections
1886(j)(3)(C)(ii)(II) and (D)(iii) of the
Act. Further, this final rule contains
changes to the list of ICD–9–CM codes
that are used in the 60 percent rule
presumptive methodology. Since these
changes are being made with a one-year
delayed implementation date, for
compliance review periods beginning
on or after October 1, 2014, no financial
PO 00000
Frm 00068
Fmt 4701
Sfmt 4700
impacts will accrue until FY 2015 from
these changes. In addition, section XIV
of this rule discusses the first
implementation (in FY 2014) of the
required 2 percentage point reduction of
the market basket increase factor for any
IRF that fails to meet the IRF quality
reporting requirements, in accordance
with section 1886(j)(7) of the Act.
We estimate that the impact of the
changes and updates described in this
final rule will be a net estimated
increase of $170 million in payments to
IRF providers. This estimate does not
include the estimated impacts of the
changes to the list of ICD–9–CM codes
that are used in the 60 percent rule
presumptive compliance (as discussed
below), which are effective for
compliance review periods on or after
October 1, 2014, or the estimated
impacts of the implementation (in FY
2014) of the required 2 percentage point
reduction of the market basket increase
factor for any IRF that fails to meet the
IRF quality reporting requirements (as
discussed below). The impact analysis
in Table 18 of this final rule represents
the projected effects of the updates to
IRF PPS payments for FY 2014
compared with the estimated IRF PPS
payments in FY 2013. We determine the
effects by estimating payments while
holding all other payment variables
constant. We use the best data available,
but we do not attempt to predict
behavioral responses to these changes,
and we do not make adjustments for
future changes in such variables as
number of discharges or case-mix.
We note that certain events may
combine to limit the scope or accuracy
of our impact analysis, because such an
analysis is future-oriented and, thus,
susceptible to forecasting errors because
of other changes in the forecasted
impact time period. Some examples
could be legislative changes made by
the Congress to the Medicare program
that would impact program funding, or
changes specifically related to IRFs.
Although some of these changes may
not necessarily be specific to the IRF
PPS, the nature of the Medicare program
is such that the changes may interact,
and the complexity of the interaction of
these changes could make it difficult to
predict accurately the full scope of the
impact upon IRFs.
In updating the rates for FY 2014, we
are adopting standard annual revisions
described in this final rule (for example,
the update to the wage and market
basket indexes used to adjust the
Federal rates). We are also
implementing a productivity adjustment
to the FY 2014 RPL market basket
increase factor in accordance with
section 1886(j)(3)(C)(ii)(I) of the Act, and
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
a 0.3 percentage point reduction to the
FY 2014 RPL market basket increase
factor in accordance with sections
1886(j)(3)(C)(ii)(II) and (D)(iii) of the
Act. We estimate the total increase in
payments to IRFs in FY 2014, relative to
FY 2013, will be approximately $170
million.
This estimate is derived from the
application of the FY 2014 RPL market
basket increase factor, as reduced by a
productivity adjustment in accordance
with section 1886(j)(3)(C)(ii)(I) of the
Act, and a 0.3 percentage point
reduction in accordance with sections
1886(j)(3)(C)(ii)(II) and (D)(iii) of the
Act, which yields an estimated increase
in aggregate payments to IRFs of $135
million. Furthermore, there is an
additional estimated $35 million
increase in aggregate payments to IRFs
due to the update to the outlier
threshold amount. Outlier payments are
estimated to increase from
approximately 2.5 percent in FY 2013 to
3.0 percent in FY 2014. Therefore,
summed together, we estimate that these
updates will result in a net increase in
estimated payments of $170 million
from FY 2013 to FY 2014.
The effects of the updates that impact
IRF PPS payment rates are shown in
Table 18. The following updates that
affect the IRF PPS payment rates are
discussed separately below:
• The effects of the update to the
outlier threshold amount, from
approximately 2.5 percent to 3.0 percent
of total estimated payments for FY 2014,
consistent with section 1886(j)(4) of the
Act.
• The effects of the annual market
basket update (using the RPL market
basket) to IRF PPS payment rates, as
required by section 1886(j)(3)(A)(i) and
sections 1886(j)(3)(C) and (D) of the Act,
including a productivity adjustment in
accordance with section
1886(j)(3)(C)(i)(I) of the Act, and a 0.3
percentage point reduction in
accordance with sections 1886(j)(3)(C)
and (D) of the Act.
• The effects of applying the budgetneutral labor-related share and wage
index adjustment, as required under
section 1886(j)(6) of the Act.
• The effects of the budget-neutral
changes to the CMG relative weights
and average length of stay values, under
the authority of section 1886(j)(2)(C)(i)
of the Act.
• The effects of the updates to the
Rural, LIP, and Teaching Status
adjustment factors, using an updated
methodology.
• The total change in estimated
payments based on the FY 2014
payment changes relative to the
estimated FY 2013 payments.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
2. Description of Table 18
Table 18 categorizes IRFs by
geographic location, including urban or
rural location, and location with respect
to CMS’s 9 census divisions (as defined
on the cost report) of the country. In
addition, the table divides IRFs into
those that are separate rehabilitation
hospitals (otherwise called freestanding
hospitals in this section), those that are
rehabilitation units of a hospital
(otherwise called hospital units in this
section), rural or urban facilities,
ownership (otherwise called for-profit,
non-profit, and government), by
teaching status, and by disproportionate
share patient percentage (DSH PP). The
top row of Table 18 shows the overall
impact on the 1,134 IRFs included in
the analysis.
The next 12 rows of Table 18 contain
IRFs categorized according to their
geographic location, designation as
either a freestanding hospital or a unit
of a hospital, and by type of ownership;
all urban, which is further divided into
urban units of a hospital, urban
freestanding hospitals, and by type of
ownership; and all rural, which is
further divided into rural units of a
hospital, rural freestanding hospitals,
and by type of ownership. There are 949
IRFs located in urban areas included in
our analysis. Among these, there are 733
IRF units of hospitals located in urban
areas and 216 freestanding IRF hospitals
located in urban areas. There are 185
IRFs located in rural areas included in
our analysis. Among these, there are 167
IRF units of hospitals located in rural
areas and 18 freestanding IRF hospitals
located in rural areas. There are 302 forprofit IRFs. Among these, there are 263
IRFs in urban areas and 39 IRFs in rural
areas. There are 688 non-profit IRFs.
Among these, there are 571 urban IRFs
and 117 rural IRFs. There are 144
government-owned IRFs. Among these,
there are 115 urban IRFs and 29 rural
IRFs.
The remaining four parts of Table 18
show IRFs grouped by their geographic
location within a region, by teaching
status, and by DSH PP. First, IRFs
located in urban areas are categorized
with respect to their location within a
particular one of the nine Census
geographic regions. Second, IRFs
located in rural areas are categorized
with respect to their location within a
particular one of the nine Census
geographic regions. In some cases,
especially for rural IRFs located in the
New England, Mountain, and Pacific
regions, the number of IRFs represented
is small. IRFs are then grouped by
teaching status, including non-teaching
IRFs, IRFs with an intern and resident
PO 00000
Frm 00069
Fmt 4701
Sfmt 4700
47927
to average daily census (ADC) ratio less
than 10 percent, IRFs with an intern and
resident to ADC ratio greater than or
equal to 10 percent and less than or
equal to 19 percent, and IRFs with an
intern and resident to ADC ratio greater
than 19 percent. Finally, IRFs are
grouped by DSH PP, including IRFs
with zero DSH PP, IRFs with a DSH PP
less than 5 percent, IRFs with a DSH PP
between 5 and less than 10 percent,
IRFs with a DSH PP between 10 and 20
percent, and IRFs with a DSH PP greater
than 20 percent.
The estimated impacts of each policy
described in this final rule to the facility
categories listed above are shown in the
columns of Table 18. The description of
each column is as follows:
• Column (1) shows the facility
classification categories described
above.
• Column (2) shows the number of
IRFs in each category in our FY 2012
analysis file.
• Column (3) shows the number of
cases in each category in our FY 2012
analysis file.
• Column (4) shows the estimated
effect of the adjustment to the outlier
threshold amount.
• Column (5) shows the estimated
effect of the update to the IRF PPS
payment rates, which includes a
productivity adjustment in accordance
with section 1886(j)(3)(C)(ii)(I) of the
Act, and a 0.3 percentage point
reduction in accordance with sections
1886(j)(3)(C)(ii)(II) and (D)(iii) of the
Act.
• Column (6) shows the estimated
effect of the update to the IRF laborrelated share and wage index, in a
budget-neutral manner.
• Column (7) shows the estimated
effect of the update to the CMG relative
weights and average length of stay
values, in a budget-neutral manner.
• Column (8) shows the estimated
effect of the update to the facility
adjustment factors using an updated
methodology, in a budget-neutral
manner.
• Column (9) compares our estimates
of the payments per discharge,
incorporating all of the proposed
policies reflected in this final rule for
FY 2014 to our estimates of payments
per discharge in FY 2013.
The average estimated increase for all
IRFs is approximately 2.3 percent. This
estimated net increase includes the
effects of the RPL market basket increase
factor for FY 2014 of 2.6 percent,
reduced by a productivity adjustment of
0.5 percentage point in accordance with
section 1886(j)(3)(C)(ii)(I) of the Act, and
further reduced by 0.3 percentage point
in accordance with sections
E:\FR\FM\06AUR2.SGM
06AUR2
47928
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
1886(j)(3)(C)(ii)(II) and (D)(iii) of the
Act. It also includes the approximate 0.5
percent overall estimated increase in
estimated IRF outlier payments from the
update to the outlier threshold amount.
Since we are making the updates to the
IRF wage index, the facility-level
adjustments, and the CMG relative
weights in a budget-neutral manner,
they will not be expected to affect total
estimated IRF payments in the
aggregate. However, as described in
more detail in each section, they will be
expected to affect the estimated
distribution of payments among
providers.
TABLE 18—IRF IMPACT TABLE FOR FY 2014
[Columns 4–9 in %]
Number
of
IRFs
Number
of
cases
Outlier
(1)
(2)
(3)
(4)
FY 2014
CBSA
wage
index
and
laborshare
CMG
Facility
adjust.
Total
percent
change
(6)
Facility classification
Adjusted
market
basket
increase
factor for
FY 2014 1
(7)
(8)
(9)
(5)
Total .................................................................
Urban unit ........................................................
Rural unit ..........................................................
Urban hospital ..................................................
Rural hospital ...................................................
Urban For-Profit ...............................................
Rural For-Profit ................................................
Urban Non-Profit ..............................................
Rural Non-Profit ...............................................
Urban Government ..........................................
Rural Government ............................................
Urban ...............................................................
Rural .................................................................
1,134
733
167
216
18
263
39
571
117
115
29
949
185
382,756
181,133
27,098
168,609
5,916
143,162
7,728
178,424
20,578
28,156
4,708
349,742
33,014
0.5
0.7
0.6
0.2
0.1
0.2
0.3
0.6
0.5
0.7
0.7
0.5
0.5
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
0.0
0.0
0.1
¥0.1
¥0.1
¥0.2
0.1
0.2
0.0
¥0.2
0.2
0.0
0.0
0.0
0.0
0.0
0.0
¥0.1
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.2
¥2.4
0.3
¥3.0
0.2
¥2.9
0.2
¥2.4
0.3
¥2.6
0.2
¥2.5
2.3
2.8
0.0
2.1
¥1.3
2.0
¥0.7
2.8
¥0.1
2.7
0.1
2.5
¥0.2
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
0.7
0.0
¥0.3
0.2
¥0.8
0.5
¥0.1
¥0.5
0.7
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.7
0.0
0.6
0.4
¥0.1
0.3
0.1
¥0.9
2.8
2.9
1.9
3.2
1.7
2.8
2.4
2.0
2.5
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
1.8
¥0.5
¥0.2
0.1
0.3
0.0
¥0.7
0.4
0.2
0.1
¥0.1
0.0
0.0
0.0
0.1
0.0
0.0
0.1
¥0.1
¥1.8
¥2.2
¥2.5
¥2.4
¥2.7
¥2.2
¥3.1
¥1.5
¥1.1
0.1
¥0.3
¥0.3
0.1
¥0.4
¥0.4
¥0.6
1.9
2.6
1.8
1.8
1.8
1.8
0.0
0.1
0.1
0.3
0.0
0.0
0.0
0.0
¥0.2
0.6
2.3
7.1
2.0
3.0
5.0
10.1
0.2
¥0.1
¥0.1
0.1
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.8
0.3
¥0.1
¥1.1
4.1
2.9
2.4
2.2
1.3
Urban by Region
Urban
Urban
Urban
Urban
Urban
Urban
Urban
Urban
Urban
New England .........................................
Middle Atlantic .......................................
South Atlantic ........................................
East North Central ................................
East South Central ................................
West North Central ...............................
West South Central ...............................
Mountain ...............................................
Pacific ....................................................
32
140
130
182
49
73
171
73
99
16,779
59,466
62,557
52,632
24,489
18,097
67,575
23,459
24,688
0.3
0.4
0.3
0.6
0.2
0.6
0.4
0.6
0.9
Rural by Region
Rural
Rural
Rural
Rural
Rural
Rural
Rural
Rural
Rural
New England ..........................................
Middle Atlantic ........................................
South Atlantic .........................................
East North Central .................................
East South Central .................................
West North Central ................................
West South Central ................................
Mountain .................................................
Pacific .....................................................
6
15
24
32
22
27
48
7
4
1,400
2,711
5,624
5,595
3,852
3,660
9,130
664
378
0.8
0.3
0.3
0.5
0.4
0.7
0.4
1.2
1.9
Teaching Status
Non-teaching ....................................................
Resident to ADC less than 10% ......................
Resident to ADC 10%–19% ............................
Resident to ADC greater than 19% .................
1,018
65
39
12
334,415
32,238
14,504
1,599
0.4
0.5
0.8
0.6
tkelley on DSK3SPTVN1PROD with RULES2
Disproportionate Share Patient Percentage (DSH PP)
DSH
DSH
DSH
DSH
DSH
PP
PP
PP
PP
PP
= 0% ..................................................
less than 5% .....................................
5%–10% ............................................
10%–20% ..........................................
greater than 20% ..............................
38
195
323
347
231
7,859
64,484
123,384
124,564
62,465
1.1
0.4
0.3
0.4
0.7
1.8
1.8
1.8
1.8
1.8
1 This column reflects the impact of the RPL market basket increase factor for FY 2014 of 1.8 percent, which includes a market basket update
of 2.6 percent, a 0.3 percentage point reduction in accordance with sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(iii) of the Act and a 0.5 percentage point reduction for the productivity adjustment as required by section 1886(j)(3)(C)(ii)(I) of the Act.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
PO 00000
Frm 00070
Fmt 4701
Sfmt 4700
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
3. Impact of the Update to the Outlier
Threshold Amount
The estimated effects of the update to
the outlier threshold adjustment are
presented in column 4 of Table 18. In
the July 30, 2012 FY 2013 IRF PPS
notice (77 FR 44618), we used FY 2011
IRF claims data (the best, most complete
data available at that time) to set the
outlier threshold amount for FY 2013 so
that estimated outlier payments would
equal 3 percent of total estimated
payments for FY 2013.
For this final rule, we are updating
our analysis using FY 2012 IRF claims
data and, based on this updated
analysis, we estimate that IRF outlier
payments as a percentage of total
estimated IRF payments are 2.5 percent
in FY 2013. We attribute this
underpayment in IRF outliers for FY
2013 to the effects of the recentlyimplemented IRF outlier reconciliation
policy (as outlined in Chapter 3, Section
140.2.8 of the Medicare Claims
Processing Manual (Pub. 100–04) that
we believe is causing a downward trend
in IRF cost-to-charge ratios (CCR). We
are seeing this downward trend in CCRs
in all of the settings for which we
implemented the outlier reconciliation
policy. Thus, we are adjusting the
outlier threshold amount in this final
rule to set total estimated outlier
payments equal to 3 percent of total
estimated payments in FY 2014. The
estimated change in total IRF payments
for FY 2014, therefore, includes an
approximate 0.5 percent increase in
payments because the estimated outlier
portion of total payments is estimated to
increase from approximately 2.5 percent
to 3 percent.
The impact of this outlier adjustment
update (as shown in column 4 of Table
18) is to increase estimated overall
payments to IRFs by about 0.5 percent.
We estimate the largest increase in
payments from the update to the outlier
threshold amount to be 1.9 percent for
rural IRFs in the Pacific region. We do
not estimate that any group of IRFs will
experience a decrease in payments from
this update.
tkelley on DSK3SPTVN1PROD with RULES2
4. Impact of the Market Basket Update
to the IRF PPS Payment Rates
The estimated effects of the market
basket update to the IRF PPS payment
rates are presented in column 5 of Table
18. In the aggregate the update will
result in a net 1.8 percent increase in
overall estimated payments to IRFs.
This net increase reflects the estimated
RPL market basket increase factor for FY
2014 of 2.6 percent, reduced by the 0.3
percentage point in accordance with
sections 1886(j)(3)(C)(ii)(II) and
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
1886(j)(3)(D)(iii) of the Act, and further
reduced by a 0.5 percentage point
productivity adjustment as required by
section 1886(j)(3)(C)(ii)(I) of the Act.
5. Impact of the CBSA Wage Index and
Labor-Related Share
In column 6 of Table 18, we present
the effects of the budget-neutral update
of the wage index and labor-related
share. The proposed changes to the
wage index and the labor-related share
are discussed together because the wage
index is applied to the labor-related
share portion of payments, so the
changes in the two have a combined
effect on payments to providers. As
discussed in section VI (C) of this final
rule, we will decrease the labor-related
share from 69.981 percent in FY 2013 to
69.494 percent in FY 2014.
In the aggregate, since these updates
to the wage index and the labor-related
share are applied in a budget-neutral
manner as required under section
1886(j)(6) of the Act, we do not estimate
that these proposed updates will affect
overall estimated payments to IRFs.
However, we estimate that these
updates will have small distributional
effects. For example, we estimate the
largest increase in payments from the
update to the CBSA wage index and
labor-related share of 0.7 percent for
urban IRFs in the New England and
Pacific regions. We estimate the largest
decrease in payments from the update to
the CBSA wage index and labor-related
share to be a 0.8 percent decrease for
urban IRFs in the East South Central
region.
6. Impact of the Update to the CMG
Relative Weights and Average Length of
Stay Values
In column 7 of Table 18, we present
the effects of the budget-neutral update
of the CMG relative weights and average
length of stay values. In the aggregate,
we do not estimate that these updates
will affect overall estimated payments to
IRFs. However, we do expect these
updates to have small distributional
effects. Freestanding rural hospitals will
see a 0.1 decrease in payments as a
result of these updates. The rural areas
affected are New England and Pacific.
The largest estimated increase in
payments as a result of these updates is
a 0.1 increase in the rural Mountain and
East South Central regions.
7. Impact of the Updates to the FacilityLevel Adjustments
In column 8 of Table 18, we present
the effects of the budget-neutral updates
to the IRF facility-level adjustment
factors (the rural, LIP, and teaching
status adjustment factors) for FY 2014.
PO 00000
Frm 00071
Fmt 4701
Sfmt 4700
47929
In the aggregate, we do not estimate that
these updates will affect overall
estimated payments to IRFs. However,
we estimate that these updates will have
distributional effects, as shown in Table
18. The largest estimated decrease in
payments as a result of these updates is
a 3.1 percent decrease to rural IRFs in
the West South Central region. The
largest estimated increase in payments
as a result of these updates is a 10.1
percent increase for teaching IRFs with
a resident to average daily census ratio
greater than 19 percent.
8. Impact of the Refinements to the
Presumptive Compliance Criteria
Methodology
As discussed in section VIII of this
final rule, we are changing the list of
ICD–9–CM codes available to meet the
presumptive compliance criteria. We
believe that these changes will improve
the accuracy and integrity of the IRF
PPS by ensuring that the cases that
qualify as meeting the 60 percent rule
truly meet the requirements in 42 CFR
412.29(b). These changes will affect all
1,134 IRFs, as these facilities will need
to change their coding practices to
continue to meet the 60 percent
compliance percentage using the
presumptive methodology. However, we
are implementing these changes with a
one-year delayed effective date, so that
these changes will be effective for
compliance review periods beginning
on or after October 1, 2014. Thus, any
potential financial impacts of these
policy changes will not accrue until FY
2015.
We estimate that the financial impact,
in the absence of any behavioral
responses to these changes on the part
of providers, would be a decrease of 6.9
percent (or $520 million) in overall
estimated payments to IRFs for FY 2015.
We note that these estimates are
unchanged from the ones we had noted
in the proposed rule, even though we
have decided to add some ICD–9–CM
codes that we had proposed for deletion
back onto the list of ICD–9–CM codes
that would qualify a patient as meeting
the 60 percent rule criteria. This is
because we inadvertently used the
wrong list of ICD–9–CM codes in our
analysis for the proposed rule. Had we
used the correct list of ICD–9–CM codes
for the proposed rule analysis, our
estimates of the financial impact of the
proposals would have been $20 million
(or 0.2%) higher than those presented in
the proposed rule, and our estimates
would therefore have reduced to $520
million (6.9 percent) for this final rule.
However, as we noted in the proposed
rule, we believe that IRFs will be able
to improve the specificity of their
E:\FR\FM\06AUR2.SGM
06AUR2
tkelley on DSK3SPTVN1PROD with RULES2
47930
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
coding practices, alter their admitting
practices, meet the 60 percent
compliance threshold under medical
review, and make other modifications to
their operations to continue to meet the
60 percent compliance threshold.
For example, we estimate that about
90 percent of the IRF cases that will
potentially be affected by the final
revisions to the presumptive
methodology codes are affected by the
removal of the non-specific codes.
However, we have been careful to
remove only those non-specific codes
for which more specific codes for the
same conditions will remain on the list
of codes that meet the presumptive
methodology. Thus, in all of these cases,
we believe that the IRF will be able to
switch to a more specific code for the
same condition, leaving the IRF’s
admission practices and classification
status unaffected.
About 1 percent of the cases that we
estimate would be affected by the final
revisions are affected by the Unilateral
Upper Extremity Amputation codes, the
Congenital Anomaly codes, and the
Miscellaneous codes combined. Thus,
we do not estimate that the removal of
these code groups will have a significant
effect on IRF admission or coding
practices, or classification status.
Finally, approximately 9 percent of
the cases that we estimate will be
affected by the final revisions involve
arthritis diagnoses. We estimate that the
revisions in this category will have the
largest potential effects on providers
because, by the very nature of these
revisions, IRFs would not have another
arthritis code on the list to code instead.
We estimate that about 14 percent of all
IRF cases are coded with the arthritis
codes that we are removing from the
list, and in 11 percent of these cases, the
arthritis code is the only code that
would qualify the patient as meeting the
60 percent rule requirements. However,
for the arthritis category of codes, we
estimate that most of these cases will
still be found to meet the 60 percent
rule requirements under medical
review, so we estimate that these
revisions will lead to few if any IRF
declassifications.
Historically, we have seen that IRFs
adapt quickly to changes in the 60
percent rule, as evidenced by the rapid
response to changes over time in the
compliance threshold. Thus, we have
every reason to believe that they will
adapt quickly to the changes to the
presumptive methodology list. In
addition, the changes will not affect
how many patients would ultimately be
shown to meet the 60 percent rule
criteria on medical review. For these
reasons, we believe that our best
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
estimate of the impact on IRFs of these
changes is no net change in Medicare
reimbursement payments. Instead, IRFs
will quickly change their coding
practices, admission practices, meet the
60 percent compliance threshold under
medical review, and make other changes
to their business practice to ensure that
they continue to meet the 60 percent
rule requirements; although we lack
data to more precisely characterize the
rule-induced costs, benefits and
transfers that would be experienced by
IRFs, their patients and other relevant
entities, we note that the $520 million
estimate appearing earlier in this section
represents an upper bound (probably an
extreme upper bound) on the costs that
would be borne by IRFs.
We intend to closely monitor provider
coding practices to these changes to the
60 percent rule in order to identify
whether those patients that we
envisioned would be served under the
IRF PPS are counting toward the
presumptive compliance percentage. We
will also monitor whether these changes
are having any unintended
consequences in terms of limiting access
to care.
Comment: One commenter requested
that CMS make its impact analysis of
the changes to the presumptive
methodology public.
Response: We used the same
methodology in the FY 2014 proposed
and final rules to estimate the impacts
of changes to the ICD–9–CM codes used
in the presumptive methodology that we
used in the May 7, 2004 to estimate the
impacts of the modifications to the 60
percent rule, with one exception. A
description of that methodology is
included in the May 7, 2004 final rule
(69 FR 25752 at 25770 through 25774).
We deviated from this methodology in
one respect. In this final rule, we report
the estimated financial impact on IRF
providers of the changes to the
presumptive compliance method. In the
May 7, 2004 final rule, however, we
reported the estimated financial impact
on Medicare’s baseline (that is, the
amount of savings that would be
projected to accrue to the Medicare
program from the policies that were
finalized in the May 7, 2004 final rule).
Thus, in the May 7, 2004 final rule, we
estimated a net decrease in IRF
admission, and then estimated that
patients that were no longer treated in
IRFs would be treated instead in another
Medicare setting (such as a skilled
nursing facility or home health care
setting). We estimated the decrease in
Medicare payments to IRFs, but added
to that estimate the total estimated
Medicare payments to the alternative
Medicare settings in which the patients
PO 00000
Frm 00072
Fmt 4701
Sfmt 4700
would have received care. Those
estimates, therefore, represent the net
savings to the Medicare program. In this
final rule, we are only estimating the
financial impacts on IRFs, so we do not
add back in the payments for the
patients treated in alternative settings.
9. Effects of Updates to the IRF QRP
This final rule sets forth a number of
updates and several policy changes to
the IRF Quality Reporting Program.
Specifically, we are taking the following
actions: (A) finalizing the use of the
following measures for the IRF QRP: (1)
Percent of Patients/Residents with
Pressure Ulcers that are New or
Worsened (NQF #0678); (2) Percent of
Residents or Patients Who Were
Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay)
(NQF #0680); (3) Influenza Vaccination
Coverage among Healthcare Personnel
(NQF #0431); (4) All-Cause Unplanned
Readmission Measure for 30 Days Post
Discharge from Inpatient Rehabilitation
Facilities Measure; (B) Adding new data
items to the IRF–PAI to collect data for
the patient influenza vaccination and
pressure ulcer measures; (C) Renumbering of Quality Indicator section
of the IRF–PAI items, using a flexible
numbering system; (D) finalizing our
proposal to change data collection for
all IRF–PAI based measures to a fiscal
year basis; (E) Finalizing our proposal to
impose quarterly data submission
deadlines for all but one measure; (F)
providing a discussion of the voluntary
reconsideration process for IRFs that
CMS finds to be out of compliance with
the reporting requirements; (G) and a
disaster waiver process.
We have based our assessment of the
effects of this final rule on all of the
actions described in the previous
paragraph. One of the changes we have
finalized is the adoption of a new
pressure ulcer measure. Currently, the
IRF QRP contains a pressure ulcer
measure that is an application of an
NQF-endorsed measure (Percent of
Residents or Patients with Pressure
Ulcers That Are New or Worsened
(Short-Stay)’’ (NQF #0678)) that we
adopted in the FY 2012 IRF PPS final
rule (76 FR 47836). That measure affects
an IRF’s annual increase factors up
through the FY 2016 annual increase
factor. We have now adopted the actual
NQF-endorsed version of this measure,
which will affect the IRF PPS increase
factor for FY 2017 and subsequent years
increase factors. We also made revisions
to the pressure ulcer items on the IRF–
PAI that providers will use to collect
data for this measure.
IRFs will incur some financial impact
from the use of the pressure ulcer
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
tkelley on DSK3SPTVN1PROD with RULES2
measure item set that will be
incorporated into the IRF–PAI. We
expect that the admission and discharge
pressure ulcer data will be collected by
a clinician such as a RN because the
assessment and staging of pressure
ulcers requires a high degree of clinical
judgment and experience. We estimate
that it will take approximately 10
minutes of time by the RN to perform
the admission pressure ulcer
assessment. We further estimate that it
will take 15 minutes of time to complete
the discharge pressure ulcer assessment.
During these time periods, the RN
would be engaged in the collection of
data for the purpose of the IRF QRP and
would not be performing patient care.
An RN or clinician with a similar level
of training and expertise should perform
the pressure ulcer assessment and
record this data on the IRF–PAI.
We believe use of the NQF-endorsed
pressure ulcer measure will cause IRFs
to incur additional annual financial
burden in the amount of $4,518.61 and
across all IRFs, $5,246,106. This burden
is comprised of the clinical and
administrative wages. The clinical
wages are based on an average hourly
wage rate of $33.23 for a RN.36 We
estimate that there are 359,000 IRF–PAI
submissions per year 37 and that there
are 1161 IRFs in the U.S. that will report
quality data to CMS. Based on these
figures, we estimate that each IRF will
submit approximately 309 IRF–PAIs per
year or 25.75 IRF–PAIs per month.38
Assuming that each IRF–PAI
submission requires 25 minutes of time
by an RN at an average hourly wage of
$33.23, the yearly cost to each IRF
would be $4,278.36 39 and the
annualized cost across all IRFs would be
$4,967,176.40 To calculate the total
amount of administrative staff wages
incurred, we estimate that this data
entry task will take no more than 3
minutes per each IRF–PAI record or
15.45 hours per each IRF annually or
36 According to the U.S. Bureau of Labor
Statistics, the mean hourly wage for a Registered
Nurse is $33.23. (See https://www.bls.gov/oes/2011/
may/oes291111.htm).
37 MedPAC, A Data Book: Health Care Spending
and the Medicare Program (June 2012), https://
www.medpac.gov/chapters/
Jun12DataBookSec8.pdf.
38 359,000 IRF–PAI reports per all IRFs per year/
1161 IRFs in U.S. = 309 IRF–PAI reports per each
IRF per year 309 IRF–PAI reports per IRF per year/
12 months per year = 26 IRF–PAI reports per each
IRF per year.
39 25 minutes × 309 IRF–PAI assessments per
each IRF per year = 7,725 minutes per each IRF per
year 7,725 minutes per each IRF per year/60
minutes per hour = 128.75 hours per each IRF per
year 128.75 hours per year × $33.23 per hour =
$4,278.36 nursing wages per each IRF per year.
40 $4,278.36 × 1161 IRF providers = $4,967,176
per all IRFs per year.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
17,937 hours across all IRFs. According
to the U.S. Bureau of Labor, the average
hourly wage for Administrative
Assistants is $15.55. We have estimated
that there are approximately 359,000
IRF–PAI submissions per year and 1161
IRFs in the U.S. that are reporting
quality data to CMS. Given this wage
information, the estimated total annual
cost across all IRFs for the time required
for entry of pressure ulcer data into the
IRF–PAI record is $278,930. We further
estimate the average yearly cost to each
IRF to be $240.25.
In addition to updating the pressure
ulcer measure, we have added 3 new
quality measures to the IRF QRP. These
measures include: (1) Percent of
Residents or Patients Who Were
Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay)
(NQF #0680), which will affect the FY
2017 increase factor and subsequent
years increase factors; (2) Influenza
Vaccination Coverage among Healthcare
Personnel (NQF #0431), which will
affect the FY 2016 increase factor and
subsequent years increase factors; and
(3) an All-Cause Unplanned
Readmission Measure for 30 Days Post
Discharge from Inpatient Rehabilitation
Facilities, which will affect the FY 2017
increase factor and subsequent years
increase factors. We discuss the impact
of each measure upon IRFs below.
IRFs will now submit their data for
the patient influenza measure (NQF
#0680) on the IRF–PAI. We have added
a new data item set consisting of 3 items
to the IRF–PAI to collect the data for
this measure. IRF staff will be required
to perform a full influenza assessment
only during the influenza vaccination
season, which has been defined by the
CDC as the time period from October 1st
(or when the vaccine becomes available)
through March 31 each year. From April
1st through September 30th, IRFs are
not required to perform a full influenza
screening. Our time estimate reflects the
averaged amount of time necessary to
complete the influenza item set both
during and outside the influenza
vaccination season.
We believe that it will be most
appropriate for a clinician, such as an
RN, to complete the influenza items
because this assessment requires
clinical judgment and knowledge of
vaccinations. An administrative
employee, such as a medical data entry
clerk or administrative assistant would
not have this level of knowledge. We do
not believe that IRFs will require
additional time by administrative staff
to encode and transmit this data to
CMS, because submission of an IRF–PAI
for each patient is already required as a
condition for payment.
PO 00000
Frm 00073
Fmt 4701
Sfmt 4700
47931
As noted above, we estimate that it
will take approximately 5 minutes to
complete the patient influenza measure
item set. We have also noted above that
there are approximately 359,000 IRF–
PAIs completed annually across all 1161
IRFs that report IRF quality data to
CMS. This breaks down to
approximately 309 IRF–PAIs completed
by each IRF yearly. We estimate that the
annual time burden for reporting the
patient influenza vaccination measure
data is 29,896 hours across all IRFs in
the U.S. and 25.75 hours for each
individual IRF. According to the U.S.
Bureau of Labor, the hourly wage for a
Registered Nurse is $33.23. The
estimated annual cost across all IRFs in
the U.S. for the submission of the
patient influenza measure data is
$993,433 and $855.67 for each
individual IRF.
IRFs will submit their data for the
staff immunization measure (NQF
#0431) to the CDC’s healthcare acquired
(HAI) surveillance Web site known as
NHSN. Data collection for this measure
is only required from October 1st (or
when the vaccine becomes available)
through March 31st each year, during
which time IRFs will be required to
keep records of which staff members
receive the influenza vaccination. IRFs
are only required to make one report to
NHSN after the close of the reporting
period on March 31st. All data must be
submitted by May 15th of each year. We
do not believe that IRFs will incur any
new burden associated with the
collection of data during the influenza
vaccination season. We believe that
most IRFs already keep records related
to the influenza vaccination of their staff
because this impacts many aspects of
their business, including but not limited
to, staff absences and transmission of
illness to other staff and patients.
We estimate that it will take each IRF
approximately 15 minutes of time once
per year to gather the data that was
collected during the influenza
vaccinations season, and prepare to
make their report to NHSN. We do not
estimate that it will take IRFs additional
time to input their data into NHSN,
once they have logged onto the system
for the purpose of submitting their
monthly CAUTI report. We believe that
this task can be completed by an
administrative person such as a Medical
Secretary Medical Data Entry Clerk. As
noted above, the average hourly wage
for Medical Records or Health
Information Technicians is $15.55.41 We
41 According to the U.S. Bureau of Labor
Statistics, the mean hourly wage for a Medical
Records & Health Information Technician is $15.55.
E:\FR\FM\06AUR2.SGM
Continued
06AUR2
47932
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
estimate that the average yearly cost to
each IRF for the reporting of this
measure will be $3.89 42 and the cost
across all IRFs will be $4,516.43
The readmission measure (All-Cause
Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient
Rehabilitation Facilities) is a claimsbased measure and, therefore, IRFs are
not required to submit any data for this
measure. We do not anticipate that IRFs
will be impacted by any financial or
time burdens as a result of the use of
this measure for the IRF QRP.
Taking all of the above-stated
information into consideration, we
estimate that the total cost to IRFs in FY
2015, including staff wages and 48
percent for fringe benefits and overhead,
is $9.2 million as related to (1) Influenza
Vaccination Coverage among Healthcare
Personnel (NQF #0431); (2) Percent of
Patients with Pressure Ulcers That Are
New or Worsened (NQF #0678); and (3)
Percent of Patients that Were
Appropriately Assessed and Given the
Influenza Vaccination (NQF #0680).
Over the past 18 months, we have
received a great deal of positive
feedback from IRFs about the IRF QRP,
and overall, IRFs have been very
receptive to the introduction of the IRF
QRP into the IRF setting. The IRF
provider community has shared many
suggestions and ideas related to the IRF
QRP. Outreach activities, such as a oneday in-person training, and 6 open door
forums were well attended. Given the
amount of positive feedback and
willingness to participate in the IRF
QRP that has been demonstrated by
IRFs, we anticipate that there will be a
relatively small number of IRFs that fail
to report the type and amount of quality
data that IRFs are required to collect and
submit. Our proposed reconsideration
process allows IRFs that receive an
initial finding of non-compliance an
opportunity to file a request for
reconsideration of this finding. Access
to this process may have the effect of
lowering even further the number of
IRFs who have not ultimately succeeded
in meeting the IRF QRP reporting
requirements.
tkelley on DSK3SPTVN1PROD with RULES2
10. Impact of the Implementation of the
2 Percentage Point Reduction in the
Increase Factor for Failure To Meet the
IRF Quality Reporting Requirements
As discussed in section XIV. of this
final rule and in accordance with
See: https://www.bls.gov/ooh/healthcare/medicalrecords-and-health-information-technicians.htm.
42 15 minutes Administrative staff time to collect
and report staff influenza measure @ $15.55 per
hour = $3.9889 per IRF per year.
43 $3.89 per IRF per year × 1161 IRFs in U.S. =
$4,621,516.
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
section 1886(j)(7) of the Act, we will
implement a 2 percentage point
reduction in the FY 2014 increase factor
for IRFs that have failed to report the
required quality reporting data to us
during the first IRF quality reporting
period (from October 1, 2012 through
December 31, 2012). In section XIV of
this final rule, we discuss how the 2
percentage point reduction will be
applied. Currently, we cannot estimate
the overall financial impacts of the
application of this reduction on
aggregate IRF PPS payments or on the
distribution of IRF PPS payments among
providers because we cannot predict the
number of or types of IRFs that will fail
to report the required quality reporting
data. IRFs are currently required to
complete the non-quality portions of the
IRF–PAI to receive payment for all
Medicare fee-for-service admissions.
Therefore, we estimate that the number
of IRFs that would fail to submit the
additional quality reporting data on the
IRF–PAI form is very low.
The official reporting period end date
for the first IRF quality reporting period
was May 15, 2013. While we made a
preliminary determination of
compliance related to IRFs in June 2013,
we feel that it would not be prudent to
release those numbers at this time. We
believe that these numbers could change
substantially during the reconsideration
process (described in section XIII. of the
May 8, 2013 (78 FR 26880) proposed
rule that will occur between July and
September 2013, and that we will not
have a true picture of IRF performance
until after this final rule is displayed.
We intend to closely monitor the effects
of this new quality reporting program on
IRF providers as we cannot predict the
number of, or types of IRFs that would
fail to report the required quality
reporting data for the first quality
reporting period.
D. Alternatives Considered
As stated in section XVIII (B) of this
final rule, we estimate that the changes
discussed in the rule would result in a
significant economic impact on IRFs.
The overall impact on all IRFs is an
estimated increase in FY 2014 payments
of $170 million (2.3 percent), relative to
FY 2013. The following is a discussion
of the alternatives considered for the
IRF PPS updates contained in this final
rule.
Section 1886(j)(3)(C) of the Act
requires the Secretary to update the IRF
PPS payment rates by an increase factor
that reflects changes over time in the
prices of an appropriate mix of goods
and services included in the covered
IRF services. Thus, we did not consider
alternatives to updating payments using
PO 00000
Frm 00074
Fmt 4701
Sfmt 4700
the estimated RPL market basket
increase factor for FY 2014. However, as
noted previously in this final rule,
section 1886(j)(3)(C)(ii)(I) of the Act
requires the Secretary to apply a
productivity adjustment to the market
basket increase factor for FY 2014 and
sections 1886(j)(3)(C)(ii)(II) and
1886(j)(3)(D)(iii) of the Act require the
Secretary to apply a 0.3 percentage
point reduction to the market basket
increase factor for FY 2014. Thus, in
accordance with section 1886(j)(3)(C) of
the Act, we are updating IRF federal
prospective payments in this final rule
by 1.8 percent (which equals the 2.6
percent estimated RPL market basket
increase factor for FY 2014 reduced by
0.3 percentage points, and further
reduced by a 0.5 percentage point
productivity adjustment as required by
section 1886(j)(3)(C)(ii)(I) of the Act).
We considered maintaining the
existing CMG relative weights and
average length of stay values for FY
2014. However, in light of recently
available data and our desire to ensure
that the CMG relative weights and
average length of stay values are as
reflective as possible of recent changes
in IRF utilization and case mix, we
believe that it is appropriate to update
the CMG relative weights and average
length of stay values at this time to
ensure that IRF PPS payments continue
to reflect as accurately as possible the
current costs of care in IRFs.
We considered maintaining the
current facility-level adjustment factors
(that is, the rural factor at 18.4 percent,
the LIP factor at 0.4613, and teaching
status adjustment factor at 0.6876).
However, as discussed in more detail in
section V (B) of this final rule, our
recent research efforts have shown
significant differences in cost structures
between freestanding IRFs and IRF units
of acute care hospitals (and CAHs). We
have found that these cost structure
differences substantially influence the
estimates of the adjustment factors. For
this reason, our regression analysis
found that the proposed inclusion of the
control variable for a facility’s status as
either a freestanding IRF hospital or an
IRF unit of an acute care hospital (or a
CAH) would greatly enhance the
accuracy of the adjustment factors for
FY 2014, as we incorporate updated
data. Further, as noted previously, we
received comments on the FY 2012 IRF
PPS proposed rule suggesting this
enhancement to the methodology. Thus,
we believe that the best approach at this
time is to update the facility-level
adjustment factors for FY 2014 using
this enhancement to the methodology.
We considered maintaining the
existing outlier threshold amount for FY
E:\FR\FM\06AUR2.SGM
06AUR2
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
2014. However, analysis of updated FY
2012 data indicates that estimated
outlier payments would be lower than 3
percent of total estimated payments for
FY 2013, by approximately 0.5 percent,
unless we updated the outlier threshold
amount. Consequently, we are adjusting
the outlier threshold amount in this
final rule to reflect a 0.5 percent
increase thereby setting the total outlier
payments equal to 3 percent, instead of
2.5 percent, of aggregate estimated
payments in FY 2014.
Finally, we considered maintaining
the current list of ICD–9–CM codes used
to determine an IRF’s compliance with
the 60 percent rule under the
presumptive methodology, or
maintaining some of the categories of
codes that we proposed removing from
the list in the proposed rule. However,
we believe that the specific ICD–9–CM
codes removed in section VIII of this
final rule results in a list that better
reflects the 60 percent rule regulations.
For example, the removal of the nonspecific diagnosis codes (as discussed in
section VIII of this final rule) is in
accordance with the trend toward
requiring more specific coding in other
Medicare payment settings, such as the
IPPS. We believe that the incentives to
use more specific codes, whenever
possible, will also lead to improvements
in the quality of care for patients by
providing more detailed information
that medical personnel can use to
enhance the specificity of patients’ care
plans. In addition, the removal of the
arthritis diagnosis codes (as discussed
in section VIII of this final rule) will
enable CMS to ensure that we only
count patients as meeting the 60 percent
rule requirements if they have met the
necessary severity and prior treatment
requirements, information which is not
discernible from the ICD–9–CM codes
themselves. With respect to the other
code categories that we are removing
from the presumptive methodology list,
we do not believe that patients who are
coded with these codes would typically
require treatment in an IRF, as described
in more detail in section VIII of this
47933
final rule. However, to give providers
more time to adjust to the changes, we
are delaying the effective date of these
changes by one year, so that the changes
will be effective for compliance review
periods beginning on or after October 1,
2014.
E. Accounting Statement
As required by OMB Circular A–4
(available at https://www.whitehouse.
gov/sites/default/files/omb/assets/omb/
circulars/a004/a-4.pdf), in Table 19, we
have prepared an accounting statement
showing the classification of the
expenditures associated with the
provisions of this final rule. Table 19
provides our best estimate of the
increase in Medicare payments under
the IRF PPS as a result of the updates
presented in this final rule based on the
data for 1,134 IRFs in our database. In
addition, the table below presents the
costs associated with the new IRF
quality reporting program requirements
for FY 2015.
TABLE 19—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES
Category
Transfers
Change in Estimated Transfers from FY 2013 IRF PPS to FY 2014 IRF PPS:
Annualized Monetized Transfers ..............................................................
From Whom to Whom? ............................................................................
$170 million.
Federal Government to IRF Medicare Providers.
Estimated Impacts in FY 2015
Refinements to the presumptive compliance criteria methodology under the ‘60 percent rule’:
Annualized Monetized Transfers ..............................................................
From Whom to Whom? ............................................................................
The estimated FY 2015 impact of the refinements to the presumptive
compliance criteria methodology reflects a decrease of payments between $0 to $520 million, depending on the IRFs behavioral responses to the changes, with $520 million representing the upper
bound.
Federal Government to IRF Medicare Providers.
Cost to updating the Quality Reporting Program for IRFs:
Annualized Monetized Costs for IRFs to Submit Data (Quality Reporting Program).
tkelley on DSK3SPTVN1PROD with RULES2
F. Conclusion
Overall, the estimated payments per
discharge for IRFs in FY 2014 are
projected to increase by 2.3 percent,
compared with the estimated payments
in FY 2013, as reflected in column 9 of
Table 18. IRF payments per discharge
are estimated to increase 2.5 percent in
urban areas and decrease 0.2 percent in
rural areas, compared with estimated FY
2013 payments. Payments per discharge
to rehabilitation units are estimated to
increase 2.8 percent in urban areas,
whereas we estimate no change in
payments per discharge to rehabilitation
units in rural areas. Payments per
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
$9.2 million.
discharge to freestanding rehabilitation
hospitals are estimated to increase 2.1
percent in urban areas and decrease 1.3
percent in rural areas.
Overall, IRFs are estimated to
experience a net increase in payments
as a result of the policies in this final
rule. The largest payment increase is
estimated to be a 3.2 percent increase
for urban IRFs located in the East North
Central region. This is due to the large
positive effect of the facility adjustment
updates for urban IRFs in this region.
Finally, the total cost to IRFs in FY 2015
is $9.2 million as related to (1) Influenza
Vaccination Coverage among Healthcare
Personnel (NQF #0431); (2) Percent of
PO 00000
Frm 00075
Fmt 4701
Sfmt 4700
Patients with Pressure Ulcers That Are
New or Worsened (NQF #0678); and (3)
Percent of Patients that Were
Appropriately Assessed and Given the
Influenza Vaccination (NQF #0680).
List of Subjects in 42 CFR Part 412
Administrative practice and
procedure, Health facilities, Medicare,
Puerto Rico, Reporting and
recordkeeping requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as follows:
E:\FR\FM\06AUR2.SGM
06AUR2
47934
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Rules and Regulations
PART 412—PROSPECTIVE PAYMENT
SYSTEMS FOR INPATIENT HOSPITAL
SERVICES
1. The authority citation for part 412
continues to read as follows:
■
Authority: Sections 1102, 1862, and 1871
of the Social Security Act (42 U.S.C. 1302,
1395y, and 1395hh).
2. Section 412.25 is amended by
revising paragraph (a)(1)(iii) to read as
follows:
■
§ 412.25 Excluded hospital units: Common
requirements.
(a) * * *
(1) * * *
(iii) Unless it is a unit in a critical
access hospital, the hospital of which an
IRF is a unit must have at least 10
staffed and maintained hospital beds
that are not excluded from the inpatient
prospective payment system, or at least
1 staffed and maintained hospital bed
for every 10 certified inpatient
rehabilitation facility beds, whichever
number is greater. Otherwise, the IRF
will be classified as an IRF hospital,
rather than an IRF unit. In the case of
an inpatient psychiatric facility unit, the
hospital must have enough beds that are
not excluded from the inpatient
prospective payment system to permit
the provision of adequate cost
information, as required by § 413.24(c)
of this chapter.
*
*
*
*
*
■ 3. Section 412.29 is amended by
revising paragraph (d) to read as
follows:
§ 412.29 Classification criteria for payment
under the inpatient rehabilitation facility
prospective payment system.
*
*
*
*
(d) Have in effect a preadmission
screening procedure under which each
tkelley on DSK3SPTVN1PROD with RULES2
*
VerDate Mar<15>2010
19:58 Aug 05, 2013
Jkt 229001
prospective patient’s condition and
medical history are reviewed to
determine whether the patient is likely
to benefit significantly from an intensive
inpatient hospital program. This
procedure must ensure that the
preadmission screening for each
Medicare Part A Fee-for-Service patient
is reviewed and approved by a
rehabilitation physician prior to the
patient’s admission to the IRF.
*
*
*
*
*
■ 4. Section 412.130 is amended by
revising paragraphs (a)(1), (a)(2) and
(a)(3) to read as follows:
§ 412.130 Retroactive adjustments for
incorrectly excluded hospitals and units.
(a) * * *
(1) A hospital that was excluded from
the prospective payment systems
specified in § 412.1(a)(1) or paid under
the prospective payment system
specified in § 412.1(a)(3), as a new
rehabilitation hospital for a cost
reporting period beginning on or after
October 1, 1991 based on a certification
under § 412.29(c) regarding the
inpatient population the hospital
planned to treat during that cost
reporting period, if the inpatient
population actually treated in the
hospital during that cost reporting
period did not meet the requirements of
§ 412.29(b).
(2) A hospital that has a unit excluded
from the prospective payment systems
specified in § 412.1(a)(1) or paid under
the prospective payment system
specified in § 412.1(a)(3), as a new
rehabilitation unit for a cost reporting
period beginning on or after October 1,
1991, based on a certification under
§ 412.29(c) regarding the inpatient
population the hospital planned to treat
in that unit during the period, if the
PO 00000
Frm 00076
Fmt 4701
Sfmt 9990
inpatient population actually treated in
the unit during that cost reporting
period did not meet the requirements of
§ 412.29(b).
(3) A hospital that added new beds to
its existing rehabilitation unit for a cost
reporting period beginning on or after
October 1, 1991 based on a certification
under § 412.29(c) regarding the
inpatient population the hospital
planned to treat in these new beds
during that cost reporting period, if the
inpatient population actually treated in
the new beds during that cost reporting
period did not meet the requirements of
§ 412.29(b).
*
*
*
*
*
■ 5. Section 412.630 is revised to read
as follows:
§ 412.630
Limitation on review.
Administrative or judicial review
under sections 1869 or 1878 of the Act,
or otherwise, is prohibited with regard
to the establishment of the methodology
to classify a patient into the case-mix
groups and the associated weighting
factors, the Federal per discharge
payment rates, additional payments for
outliers and special payments, and the
area wage index.
Authority: (Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program).
Dated: July 23, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: July 29, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013–18770 Filed 7–31–13; 4:15 pm]
BILLING CODE 4120–01–P
E:\FR\FM\06AUR2.SGM
06AUR2
Agencies
[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Rules and Regulations]
[Pages 47859-47934]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18770]
[[Page 47859]]
Vol. 78
Tuesday,
No. 151
August 6, 2013
Part III
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Part 412
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment
System for Federal Fiscal Year 2014; Rules
Federal Register / Vol. 78 , No. 151 / Tuesday, August 6, 2013 /
Rules and Regulations
[[Page 47860]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 412
[CMS-1448-F]
RIN 0938-AR66
Medicare Program; Inpatient Rehabilitation Facility Prospective
Payment System for Federal Fiscal Year 2014
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule updates the prospective payment rates for
inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY)
2014 (for discharges occurring on or after October 1, 2013 and on or
before September 30, 2014) as required by the statute. This final rule
also revised the list of diagnosis codes that may be counted toward an
IRF's ``60 percent rule'' compliance calculation to determine
``presumptive compliance,'' update the IRF facility-level adjustment
factors using an enhanced estimation methodology, revise sections of
the Inpatient Rehabilitation Facility-Patient Assessment Instrument,
revise requirements for acute care hospitals that have IRF units,
clarify the IRF regulation text regarding limitation of review, update
references to previously changed sections in the regulations text, and
revise and update quality measures and reporting requirements under the
IRF quality reporting program.
DATES: Effective Dates: The regulatory amendments in this rule are
effective October 1, 2013, except for the amendment to Sec. 412.25
which is effective October 1, 2014.
Applicability Dates: The revisions to the list of diagnosis codes
that are used to determine presumptive compliance under the ``60
percent rule'' are applicable for compliance review periods beginning
on or after October 1, 2014. The updated IRF prospective payment rates
are applicable for IRF discharges occurring on or after October 1, 2013
and on or before September 30, 2014 (FY 2014). The changes to the
Inpatient Rehabilitation Facility-Patient Assessment Instrument, the
amendments to Sec. 412.25, and the revised and updated quality
measures and reporting requirements under the IRF quality reporting
program are applicable for IRF discharges occurring on or after October
1, 2014.
FOR FURTHER INFORMATION CONTACT: Gwendolyn Johnson, (410) 786-6954, for
general information.
Caroline Gallaher, (410) 786-8705, for information about the
quality reporting program.
Susanne Seagrave, (410) 786-0044 or Kadie Thomas, (410) 786-0468,
for information about the payment policies and the proposed payment
rates.
SUPPLEMENTARY INFORMATION: The IRF PPS Addenda along with other
supporting documents and tables referenced in this final rule are
available through the Internet on the CMS Web site at https://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/.
Executive Summary
A. Purpose
This final rule updates the payment rates for inpatient
rehabilitation facilities (IRFs) for federal fiscal year (FY) 2014
(that is, for discharges occurring on or after October 1, 2013 and on
or before September 30, 2014) as required under section 1886(j)(3)(C)
of the Social Security Act (the Act). Section 1886(j)(5) of the Act
requires the Secretary to publish in the Federal Register on or before
the August 1 that precedes the start of each fiscal year, the
classification and weighting factors for the IRF prospective payment
system's (PPS) case-mix groups and a description of the methodology and
data used in computing the prospective payment rates for that fiscal
year.
B. Summary of Major Provisions
In this final rule, we use the methods described in the July 30,
2012 FY 2013 IRF PPS notice (77 FR 44618) to update the federal
prospective payment rates for FY 2014 using updated FY 2012 IRF claims
and the most recent available IRF cost report data. We are also
revising the list of diagnosis codes that are used to determine
presumptive compliance under the ``60 percent rule,'' updating the IRF
facility-level adjustment factors using an enhanced estimation
methodology, revising sections of the Inpatient Rehabilitation
Facility-Patient Assessment Instrument, revising requirements for acute
care hospitals that have IRF units, clarifying the IRF regulation text
regarding limitation of review, updating references to previously
changed sections in the regulations text, and revising and updating
quality measures and reporting requirements under the IRF quality
reporting program.
C. Summary of Costs, Benefits and Transfers
------------------------------------------------------------------------
Provision description Transfers
------------------------------------------------------------------------
FY 2014 IRF PPS payment rate The overall economic impact of this final
update. rule is an estimated $170 million in
increased payments from the Federal
government to IRFs during FY 2014.
Refinements to the The estimated FY 2015 impact of the
presumptive compliance refinements to the presumptive
method under the `60 percent compliance method reflects a decrease of
rule'. payments between $0 to $520 million,
depending on the IRFs' behavioral
responses to the changes, with $520
million representing the upper bound.
------------------------------------------------------------------------
Provision description Costs
------------------------------------------------------------------------
New quality reporting program The total costs in FY 2015 for IRFs as a
requirements. result of the new quality reporting
requirements are estimated to be $9.2
million.
------------------------------------------------------------------------
To assist readers in referencing sections contained in this
document, we are providing the following Table of Contents..
Table of Contents
I. Background
A. Historical Overview of the Inpatient Rehabilitation Facility
Prospective Payment System (IRF PPS)
B. Provisions of the Affordable Care Act Affecting the IRF PPS
in FY 2012 and Beyond
C. Operational Overview of the Current IRF PPS
II. Summary of Provisions of the Proposed Rule
A. Proposed Updates to the IRF Federal Prospective Payment Rates
for Federal Fiscal Year (FY) 2014
B. Proposed Revisions to Existing Regulation Text
[[Page 47861]]
III. Analysis and Responses to Public Comments
IV. Update to the Case-Mix Group (CMG) Relative Weights and Average
Length of Stay Values for FY 2014
V. Updates to the Facility-Level Adjustment Factors for FY 2014
A. Background on Facility-Level Adjustments
B. Updates to the IRF Facility-Level Adjustment Factors
C. Budget Neutrality Methodology for the Updates to the IRF
Facility-Level Adjustment Factors
VI. FY 2014 IRF PPS Federal Prospective Payment Rates
A. Market Basket Increase Factor, Productivity Adjustment, and
Other Adjustment for FY 2014
B. Secretary's Final Recommendation
C. Labor-Related Share for FY 2014
D. Wage Adjustment
E. Description of the IRF Standard Conversion Factor and Payment
Rates for FY 2014
F. Example of the Methodology for Adjusting the Federal
Prospective Payment Rates
VII. Update to Payments for High-Cost Outliers Under the IRF PPS
A. Update to the Outlier Threshold Amount for FY 2014
B. Update to the IRF Cost-to-Charge Ratio Ceiling and Urban/
Rural Averages
VIII. Refinements to the Presumptive Compliance Methodology
A. Background on the Compliance Percentage
B. Changes to the ICD-9-CM Codes That Are Used To Determine
Presumptive Compliance
IX. Non-Quality Related Revisions to IRF-PAI Sections
A. Updates
B. Additions
C. Deletions
D. Changes
X. Technical Corrections to the Regulations at Sec. 412.130
XI. Revisions to the Conditions of Payment for IRF Units Under the
IRF PPS
XII. Clarification of the Regulations at Sec. 412.630
XIII. Revision to the Regulations at Sec. 412.29
XIV. Revisions and Updates to the Quality Reporting Program for IRFs
A. Background and Statutory Authority
B. Quality Measures Previously Finalized and Currently in Use
for the IRF Quality Reporting Program
C. New IRF QRP Quality Measures Affecting the FY 2016 and FY
2017 IRF PPS Annual Increase Factor, and Subsequent Year Increase
Factors
D. Changes to the IRF-PAI That Are Related to the IRF Quality
Reporting Program
E. Change in Data Collection and Submission Periods for Future
Program Years
F. Reconsideration and Appeals Process
G. Policy for Granting of a Waiver of the IRF QRP Data
Submission Requirements in Case of Disaster or Extraordinary
Circumstances
H. Public Display of Data Quality Measures for the IRF QRP
Program
I. Method for Applying the Reduction to the FY 2014 IRF Increase
Factor for IRFs That Fail To Meet the Quality Reporting Requirements
XV. Miscellaneous Comments
XVI. Provisions of the Final Regulations
A. Payment Provision Changes
B. Revisions to Existing Regulation Text
XVII. Collection of Information Requirements
A. ICRs Regarding IRF QRP
B. ICRs Regarding Non-Quality Related Changes to the IRF-PAI
XVIII. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impacts
C. Detailed Economic Analysis
D. Alternatives Considered
E. Accounting Statement
F. Conclusion
Regulation Text
I. Background
A. Historical Overview of the Inpatient Rehabilitation Facility
Prospective Payment System (IRF PPS)
Section 1886(j) of the Act provides for the implementation of a
per-discharge prospective payment system (PPS) for inpatient
rehabilitation hospitals and inpatient rehabilitation units of a
hospital (hereinafter referred to as IRFs).
Payments under the IRF PPS encompass inpatient operating and
capital costs of furnishing covered rehabilitation services (that is,
routine, ancillary, and capital costs), but not direct graduate medical
education costs, costs of approved nursing and allied health education
activities, bad debts, and other services or items outside the scope of
the IRF PPS. Although a complete discussion of the IRF PPS provisions
appears in the original FY 2002 IRF PPS final rule (66 FR 41316) and
the FY 2006 IRF PPS final rule (70 FR 47880), we are providing below a
general description of the IRF PPS for fiscal years (FYs) 2002 through
2013.
Under the IRF PPS from FY 2002 through FY 2005, as described in the
FY 2002 IRF PPS final rule (66 FR 41316), the federal prospective
payment rates were computed across 100 distinct case-mix groups (CMGs).
We constructed 95 CMGs using rehabilitation impairment categories
(RICs), functional status (both motor and cognitive), and age (in some
cases, cognitive status and age may not be a factor in defining a CMG).
In addition, we constructed five special CMGs to account for very short
stays and for patients who expire in the IRF.
For each of the CMGs, we developed relative weighting factors to
account for a patient's clinical characteristics and expected resource
needs. Thus, the weighting factors accounted for the relative
difference in resource use across all CMGs. Within each CMG, we created
tiers based on the estimated effects that certain comorbidities would
have on resource use.
We established the federal PPS rates using a standardized payment
conversion factor (formerly referred to as the budget-neutral
conversion factor). For a detailed discussion of the budget-neutral
conversion factor, please refer to our FY 2004 IRF PPS final rule (68
FR 45684 through 45685). In the FY 2006 IRF PPS final rule (70 FR
47880), we discussed in detail the methodology for determining the
standard payment conversion factor.
We applied the relative weighting factors to the standard payment
conversion factor to compute the unadjusted federal prospective payment
rates under the IRF PPS from FYs 2002 through 2005. Within the
structure of the payment system, we then made adjustments to account
for interrupted stays, transfers, short stays, and deaths. Finally, we
applied the applicable adjustments to account for geographic variations
in wages (wage index), the percentage of low-income patients, location
in a rural area (if applicable), and outlier payments (if applicable)
to the IRF's unadjusted federal prospective payment rates.
For cost reporting periods that began on or after January 1, 2002
and before October 1, 2002, we determined the final prospective payment
amounts using the transition methodology prescribed in section
1886(j)(1) of the Act. Under this provision, IRFs transitioning into
the PPS were paid a blend of the federal IRF PPS rate and the payment
that the IRF would have received had the IRF PPS not been implemented.
This provision also allowed IRFs to elect to bypass this blended
payment and immediately be paid 100 percent of the federal IRF PPS
rate. The transition methodology expired as of cost reporting periods
beginning on or after October 1, 2002 (FY 2003), and payments for all
IRFs now consist of 100 percent of the federal IRF PPS rate.
We established a CMS Web site as a primary information resource for
the IRF PPS. The Web site is: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/. The Web site may
be accessed to download or view publications, software, data
specifications, educational materials, and other information pertinent
to the IRF PPS.
Section 1886(j) of the Act confers broad statutory authority upon
the Secretary to propose refinements to the IRF PPS. In the FY 2006 IRF
PPS final rule (70 FR 47880) and in correcting amendments to the FY
2006 IRF PPS
[[Page 47862]]
final rule (70 FR 57166) that we published on September 30, 2005, we
finalized a number of refinements to the IRF PPS case-mix
classification system (the CMGs and the corresponding relative weights)
and the case-level and facility-level adjustments. These refinements
included the adoption of the Office of Management and Budget's (OMB)
Core-Based Statistical Area (CBSA) market definitions, modifications to
the CMGs, tier comorbidities, and CMG relative weights, implementation
of a new teaching status adjustment for IRFs, revision and rebasing of
the market basket index used to update IRF payments, and updates to the
rural, low-income percentage (LIP), and high-cost outlier adjustments.
Beginning with the FY 2006 IRF PPS final rule (70 FR 47908 through
47917), the market basket index used to update IRF payments is a market
basket reflecting the operating and capital cost structures for
freestanding IRFs, freestanding inpatient psychiatric facilities
(IPFs), and long-term care hospitals (LTCHs) (hereafter referred to as
the rehabilitation, psychiatric, and long-term care (RPL) market
basket). Any reference to the FY 2006 IRF PPS final rule in this final
rule also includes the provisions effective in the correcting
amendments. For a detailed discussion of the final key policy changes
for FY 2006, please refer to the FY 2006 IRF PPS final rule (70 FR
47880 and 70 FR 57166).
In the FY 2007 IRF PPS final rule (71 FR 48354), we further refined
the IRF PPS case-mix classification system (the CMG relative weights)
and the case-level adjustments, to ensure that IRF PPS payments would
continue to reflect as accurately as possible the costs of care. For a
detailed discussion of the FY 2007 policy revisions, please refer to
the FY 2007 IRF PPS final rule (71 FR 48354).
In the FY 2008 IRF PPS final rule (72 FR 44284), we updated the
federal prospective payment rates and the outlier threshold, revised
the IRF wage index policy, and clarified how we determine high-cost
outlier payments for transfer cases. For more information on the policy
changes implemented for FY 2008, please refer to the FY 2008 IRF PPS
final rule (72 FR 44284), in which we published the final FY 2008 IRF
federal prospective payment rates.
After publication of the FY 2008 IRF PPS final rule (72 FR 44284),
section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007
(Pub. L. 110-173, enacted on December 29, 2007) (MMSEA), amended
section 1886(j)(3)(C) of the Act to apply a zero percent increase
factor for FYs 2008 and 2009, effective for IRF discharges occurring on
or after April 1, 2008. Section 1886(j)(3)(C) of the Act required the
Secretary to develop an increase factor to update the IRF federal
prospective payment rates for each FY. Based on the legislative change
to the increase factor, we revised the FY 2008 federal prospective
payment rates for IRF discharges occurring on or after April 1, 2008.
Thus, the final FY 2008 IRF federal prospective payment rates that were
published in the FY 2008 IRF PPS final rule (72 FR 44284) were
effective for discharges occurring on or after October 1, 2007 and on
or before March 31, 2008; and the revised FY 2008 IRF federal
prospective payment rates were effective for discharges occurring on or
after April 1, 2008 and on or before September 30, 2008. The revised FY
2008 federal prospective payment rates are available on the CMS Web
site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html.
In the FY 2009 IRF PPS final rule (73 FR 46370), we updated the CMG
relative weights, the average length of stay values, and the outlier
threshold; clarified IRF wage index policies regarding the treatment of
``New England deemed'' counties and multi-campus hospitals; and revised
the regulation text in response to section 115 of the MMSEA to set the
IRF compliance percentage at 60 percent (the ``60 percent rule'') and
continue the practice of including comorbidities in the calculation of
compliance percentages. We also applied a zero percent market basket
increase factor for FY 2009 in accordance with section 115 of the
MMSEA. For more information on the policy changes implemented for FY
2009, please refer to the FY 2009 IRF PPS final rule (73 FR 46370), in
which we published the final FY 2009 IRF federal prospective payment
rates.
In the FY 2010 IRF PPS final rule (74 FR 39762) and in correcting
amendments to the FY 2010 IRF PPS final rule (74 FR 50712) that we
published on October 1, 2009, we updated the federal prospective
payment rates, the CMG relative weights, the average length of stay
values, the rural, LIP, and teaching status adjustment factors, and the
outlier threshold; implemented new IRF coverage requirements for
determining whether an IRF claim is reasonable and necessary; and
revised the regulation text to require IRFs to submit patient
assessments on Medicare Advantage (MA) (Medicare Part C) patients for
use in the 60 percent rule calculations. Any reference to the FY 2010
IRF PPS final rule in this final rule also includes the provisions
effective in the correcting amendments. For more information on the
policy changes implemented for FY 2010, please refer to the FY 2010 IRF
PPS final rule (74 FR 39762 and 74 FR 50712), in which we published the
final FY 2010 IRF federal prospective payment rates.
After publication of the FY 2010 IRF PPS final rule (74 FR 39762),
section 3401(d) of the Patient Protection and Affordable Care Act (Pub.
L. 111-148, enacted on March 23, 2010), as amended by section 10319 of
the same Act and by section 1105 of the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152, enacted on March 30, 2010)
(collectively, hereafter referred to as ``The Affordable Care Act''),
amended section 1886(j)(3)(C) of the Act and added section
1886(j)(3)(D) of the Act. Section 1886(j)(3)(C) of the Act requires the
Secretary to estimate a multi-factor productivity adjustment to the
market basket increase factor, and to apply other adjustments as
defined by the Act. The productivity adjustment applies to FYs from
2012 forward. The other adjustments apply to FYs 2010 to 2019.
Sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(i) of the Act
defined the adjustments that were to be applied to the market basket
increase factors in FYs 2010 and 2011. Under these provisions, the
Secretary was required to reduce the market basket increase factor in
FY 2010 by a 0.25 percentage point adjustment. Notwithstanding this
provision, in accordance with section 3401(p) of the Affordable Care
Act, the adjusted FY 2010 rate was only to be applied to discharges
occurring on or after April 1, 2010. Based on the self-implementing
legislative changes to section 1886(j)(3) of the Act, we adjusted the
FY 2010 federal prospective payment rates as required, and applied
these rates to IRF discharges occurring on or after April 1, 2010 and
on or before September 30, 2010. Thus, the final FY 2010 IRF federal
prospective payment rates that were published in the FY 2010 IRF PPS
final rule (74 FR 39762) were used for discharges occurring on or after
October 1, 2009 and on or before March 31, 2010; and the adjusted FY
2010 IRF federal prospective payment rates applied to discharges
occurring on or after April 1, 2010 and on or before September 30,
2010. The adjusted FY 2010 federal prospective payment rates are
available on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html.
[[Page 47863]]
In addition, sections 1886(j)(3)(C) and (D) of the Act also
affected the FY 2010 IRF outlier threshold amount because they required
an adjustment to the FY 2010 RPL market basket increase factor, which
changed the standard payment conversion factor for FY 2010.
Specifically, the original FY 2010 IRF outlier threshold amount was
determined based on the original estimated FY 2010 RPL market basket
increase factor of 2.5 percent and the standard payment conversion
factor of $13,661. However, as adjusted, the IRF prospective payments
are based on the adjusted RPL market basket increase factor of 2.25
percent and the revised standard payment conversion factor of $13,627.
To maintain estimated outlier payments for FY 2010 equal to the
established standard of 3 percent of total estimated IRF PPS payments
for FY 2010, we revised the IRF outlier threshold amount for FY 2010
for discharges occurring on or after April 1, 2010 and on or before
September 30, 2010. The revised IRF outlier threshold amount for FY
2010 was $10,721.
Sections 1886(j)(3)(c)(ii)(II) and 1886(j)(3)(D)(i) of the Act also
required the Secretary to reduce the market basket increase factor in
FY 2011 by a 0.25 percentage point adjustment. The FY 2011 IRF PPS
notice (75 FR 42836) and the correcting amendments to the FY 2011 IRF
PPS notice (75 FR 70013, November 16, 2010) described the required
adjustments to the FY 2011 and FY 2010 IRF PPS federal prospective
payment rates and outlier threshold amount for IRF discharges occurring
on or after April 1, 2010 and on or before September 30, 2011. It also
updated the FY 2011 federal prospective payment rates, the CMG relative
weights, and the average length of stay values. Any reference to the FY
2011 IRF PPS notice in this final rule also includes the provisions
effective in the correcting amendments. For more information on the FY
2010 and FY 2011 adjustments or the updates for FY 2011, please refer
to the FY 2011 IRF PPS notice (75 FR 42836 and 75 FR 70013).
In the FY 2012 IRF PPS final rule (76 FR 47836), we updated the IRF
federal prospective payment rates, rebased and revised the RPL market
basket, and established a new quality reporting program for IRFs in
accordance with section 1886(j)(7) of the Act. We also revised
regulation text for the purpose of updating and providing greater
clarity. For more information on the policy changes implemented for FY
2012, please refer to the FY 2012 IRF PPS final rule (76 FR 47836), in
which we published the final FY 2012 IRF federal prospective payment
rates.
The July 30, 2012 FY 2013 IRF PPS notice (77 FR 44618) described
the required adjustments to the FY 2013 federal prospective payment
rates and outlier threshold amount for IRF discharges occurring on or
after October 1, 2012 and on or before September 30, 2013. It also
updated the FY 2013 federal prospective payment rates, the CMG relative
weights, and the average length of stay values. For more information on
the updates for FY 2013, please refer to the July 30, 2012 FY 2013 IRF
PPS notice (77 FR 44618).
B. Provisions of the Affordable Care Act Affecting the IRF PPS in FY
2012 and Beyond
The Affordable Care Act included several provisions that affect the
IRF PPS in FYs 2012 and beyond. In addition to what was discussed
above, section 3401(d) of the Affordable Care Act also added section
1886(j)(3)(C)(ii)(I) (providing for a ``productivity adjustment'' for
fiscal year 2012 and each subsequent fiscal year). The productivity
adjustment for FY 2014 is discussed in section VI.A. of this final
rule. Section 3401(d) of the Affordable Care Act requires an additional
0.3 percentage point adjustment to the IRF increase factor for FY 2014,
as discussed in section VI.A. of this final rule. Section
1886(j)(3)(C)(ii)(II) of the Act notes that the application of these
adjustments to the market basket update may result in an update that is
less than 0.0 for a fiscal year and in payment rates for a fiscal year
being less than such payment rates for the preceding fiscal year.
Section 3004(b) of the Affordable Care Act also addressed the IRF
PPS program. It reassigned the previously designated section 1886(j)(7)
of the Act to section 1886(j)(8) and inserted a new section 1886(j)(7),
which contains new requirements for the Secretary to establish a
quality reporting program for IRFs. Under that program, data must be
submitted in a form and manner, and at a time specified by the
Secretary. Beginning in FY 2014, section 1886(j)(7)(A)(i) of the Act
will require application of a 2 percentage point reduction of the
applicable market basket increase factor for IRFs that fail to comply
with the quality data submission requirements. Application of the 2
percentage point reduction may result in an update that is less than
0.0 for a fiscal year and in payment rates for a fiscal year being less
than such payment rates for the preceding fiscal year. Reporting-based
reductions to the market basket increase factor will not be cumulative;
they will only apply for the FY involved.
Under section 1886(j)(7)(D)(i) and (ii) of the Act, the Secretary
is generally required to select quality measures for the IRF quality
reporting program from those that have been endorsed by the consensus-
based entity which holds a performance measurement contract under
section 1890(a) of the Act. This contract is currently held by the
National Quality Forum (NQF). So long as due consideration is given to
measures that have been endorsed or adopted by a consensus-based
organization, section 1886(j)(7)(D)(ii) of the Act authorizes the
Secretary to select non-endorsed measures for specified areas or
medical topics when there are no feasible or practical endorsed
measure(s). Under section 1886(j)(7)(D)(iii) of the Act, the Secretary
is required to publish the measures that will be used in FY 2014 no
later than October 1, 2012.
Section 1886(j)(7)(E) of the Act requires the Secretary to
establish procedures for making the IRF PPS quality reporting data
available to the public. In so doing, the Secretary must ensure that
IRFs have the opportunity to review any such data prior to its release
to the public. Future rulemaking will address these public reporting
obligations.
C. Operational Overview of the Current IRF PPS
As described in the FY 2002 IRF PPS final rule, upon the admission
and discharge of a Medicare Part A Fee-for-Service patient, the IRF is
required to complete the appropriate sections of a patient assessment
instrument (PAI), designated as the Inpatient Rehabilitation Facility-
Patient Assessment Instrument (IRF-PAI). In addition, beginning with
IRF discharges occurring on or after October 1, 2009, the IRF is also
required to complete the appropriate sections of the IRF-PAI upon the
admission and discharge of each Medicare Part C (Medicare Advantage)
patient, as described in the FY 2010 IRF PPS final rule. All required
data must be electronically encoded into the IRF-PAI software product.
Generally, the software product includes patient classification
programming called the GROUPER software. The GROUPER software uses
specific IRF-PAI data elements to classify (or group) patients into
distinct CMGs and account for the existence of any relevant
comorbidities.
The GROUPER software produces a 5-digit CMG number. The first digit
is an alpha-character that indicates the comorbidity tier. The last 4
digits
[[Page 47864]]
represent the distinct CMG number. Free downloads of the Inpatient
Rehabilitation Validation and Entry (IRVEN) software product, including
the GROUPER software, are available on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Software.html.
Once a Medicare Fee-for-Service Part A patient is discharged, the
IRF submits a Medicare claim as a Health Insurance Portability and
Accountability Act of 1996 (Pub. L. 104-191, enacted on August 21,
1996) (HIPAA) compliant electronic claim or, if the Administrative
Simplification Compliance Act of 2002 (Pub. L. 107-105, enacted on
December 27, 2002) (ASCA) permits, a paper claim (a UB-04 or a CMS-1450
as appropriate) using the five-digit CMG number and sends it to the
appropriate Medicare Administrative Contractor (MAC). In addition, once
a Medicare Advantage patient is discharged, in accordance with the
Medicare Claims Processing Manual chapter 3 section 20.3 (Pub. 100-04),
hospitals (including IRFs) must submit an informational-only bill (TOB
111) which includes Condition Code 04 to their Medicare contractor.
This will ensure that the Medicare Advantage days are included in the
hospital's Supplemental Security Income (SSI) ratio (used in
calculating the IRF low-income percentage adjustment) for Fiscal Year
2007 and beyond. Claims submitted to Medicare must comply with both
ASCA and HIPAA.
Section 3 of the ASCA amends section 1862(a) of the Act by adding
paragraph (22) which requires the Medicare program, subject to section
1862(h) of the Act, to deny payment under Part A or Part B for any
expenses for items or services ``for which a claim is submitted other
than in an electronic form specified by the Secretary.'' Section
1862(h) of the Act, in turn, provides that the Secretary shall waive
such denial in situations in which there is no method available for the
submission of claims in an electronic form or the entity submitting the
claim is a small provider. In addition, the Secretary also has the
authority to waive such denial ``in such unusual cases as the Secretary
finds appropriate.'' For more information, see the ``Medicare Program;
Electronic Submission of Medicare Claims'' final rule (70 FR 71008,
November 25, 2005). Our instructions for the limited number of Medicare
claims submitted on paper are available at https://www.cms.gov/manuals/downloads/clm104c25.pdf.
Section 3 of the ASCA operates in the context of the administrative
simplification provisions of HIPAA, which include, among others, the
requirements for transaction standards and code sets codified in 45
CFR, parts 160 and 162, subparts A and I through R (generally known as
the Transactions Rule). The Transactions Rule requires covered
entities, including covered healthcare providers, to conduct covered
electronic transactions according to the applicable transaction
standards. (See the CMS program claim memoranda at https://www.cms.gov/ElectronicBillingEDITrans/ and listed in the addenda to the Medicare
Intermediary Manual, Part 3, section 3600).
The MAC processes the claim through its software system. This
software system includes pricing programming called the ``PRICER''
software. The PRICER software uses the CMG number, along with other
specific claim data elements and provider-specific data, to adjust the
IRF's prospective payment for interrupted stays, transfers, short
stays, and deaths, and then applies the applicable adjustments to
account for the IRF's wage index, percentage of low-income patients,
rural location, and outlier payments. For discharges occurring on or
after October 1, 2005, the IRF PPS payment also reflects the teaching
status adjustment that became effective as of FY 2006, as discussed in
the FY 2006 IRF PPS final rule (70 FR 47880).
II. Summary of Provisions of the Proposed Rule
In the FY 2014 IRF PPS proposed rule (78 FR 26880), we proposed to
update the IRF Federal prospective payment rates, to revise the list of
eligible International Classification of Diseases, Ninth Revision,
Clinical Modification (ICD-9-CM) diagnosis codes that are used to
determine presumptive compliance under the ``60 percent rule,'' to
update the IRF facility-level adjustment factors, to revise the
Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-
PAI), to revise requirements for acute care hospitals that have IRF
units, clarify the IRF regulation text regarding limitation of review,
and to revise and update quality measures and reporting requirements
under the quality reporting program for IRFs. We also proposed to
revise existing regulations text for the purpose of updating and
providing greater clarity. These proposals were as follows:
A. Proposed Updates to the IRF Federal Prospective Payment Rates for
Federal Fiscal Year (FY) 2014
The proposed updates to the IRF federal prospective payment rates
for FY 2014 were as follows:
Update the FY 2014 IRF PPS relative weights and average
length of stay values using the most current and complete Medicare
claims and cost report data in a budget-neutral manner, as discussed in
section III. of the FY 2014 IRF PPS proposed rule (78 FR 26880, 26885
through 26888).
Update the FY 2014 IRF PPS facility-level adjustment
factors, using the most current and complete Medicare claims and cost
report data with an enhanced estimation methodology, in a budget-
neutral manner, as discussed in section IV of the FY 2014 IRF PPS
proposed rule (78 FR 26880, 26888 through 26890).
Update the FY 2014 IRF PPS payment rates by the proposed
market basket increase factor, based upon the most current data
available, with a 0.3 percentage point reduction as required by
sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(iii) of the Act and a
proposed productivity adjustment required by section
1886(j)(3)(C)(ii)(I) of the Act, as described in section V of the FY
2014 IRF PPS proposed rule (78 FR 26880, 26890 through 26891).
Discuss the Secretary's Proposed Recommendation for
updating IRF PPS payments for FY 2014, in accordance with the statutory
requirements, as described in section V of the FY 2014 IRF PPS proposed
rule (78 FR 26880 at 26891).
Update the FY 2014 IRF PPS payment rates by the FY 2014
wage index and the labor-related share in a budget-neutral manner, as
discussed in section V of the FY 2014 IRF PPS proposed rule (78 FR
26880, 26891 through 26892).
Describe the calculation of the IRF Standard Payment
Conversion Factor for FY 2014, as discussed in section V of the FY 2014
IRF PPS proposed rule (78 FR 26880 at 26892).
Update the outlier threshold amount for FY 2014, as
discussed in section VI of the FY 2014 IRF PPS proposed rule (78 FR
26880 at 26895).
Update the cost-to-charge ratio (CCR) ceiling and urban/
rural average CCRs for FY 2014, as discussed in section VI of the FY
2014 IRF PPS proposed rule (78 FR 26880 at 26895).
Describe proposed revisions to the list of eligible ICD-9-
CM diagnosis codes that are used to determine presumptive compliance
under the 60 percent rule in section VII of the FY
[[Page 47865]]
2014 IRF PPS proposed rule (78 FR 26880, 26895 through 26906).
Describe proposed non-quality-related revisions to IRF-PAI
sections in section VIII of the FY 2014 IRF PPS proposed rule (78 FR
26880, 26906 through 26907).
Describe proposed revisions and updates to quality
measures and reporting requirements under the quality reporting program
for IRFs in accordance with section 1886(j)(7) of the Act, as discussed
in section XIII of the FY 2014 IRF PPS proposed rule (78 FR 26880,
26909 through 26922).
B. Proposed Revisions to Existing Regulation Text
In the FY 2014 IRF PPS proposed rule (78 FR 26880), we also
proposed the following revisions to the existing regulations:
Revisions to Sec. 412.25(a)(1)(iii) to specify a minimum
required number of beds that are not excluded from the inpatient
prospective payment system (IPPS) for a hospital that has an IRF unit,
as described in section X of the FY 2014 IRF PPS proposed rule (78 FR
26880 at 26908).
Technical corrections to Sec. 412.130, to reflect prior
changes to the regulations at Sec. 412.29 and Sec. 412.30 that we
made in the FY 2012 IRF PPS final rule (76 FR 47836), as described in
section IX of the FY 2014 IRF PPS proposed rule (78 FR 26880, 26907
through 26908).
Clarifications to Sec. 412.630, to reflect the scope of
section 1886(j)(8) of the Act, as described in section XI. of the FY
2014 IRF PPS proposed rule (78 FR 26880 at 26908).
Revision to Sec. 412.29(d), to clarify that Medicare
requires the rehabilitation physician's review and concurrence on the
preadmission screening for Medicare Part A Fee-for-Service patients
only, as described in section XII of the FY 2014 IRF PPS proposed rule
(78 FR 26880, 26908 through 26909).
III. Analysis and Responses to Public Comments
We received 47 timely responses from the public, many of which
contained multiple comments on the FY 2014 IRF PPS proposed rule (78 FR
26880). We received comments from various trade associations, inpatient
rehabilitation facilities, individual physicians, therapists,
clinicians, health care industry organizations, law firms and health
care consulting firms. The following sections, arranged by subject
area, include a summary of the public comments that we received, and
our responses.
IV. Update to the Case-Mix Group (CMG) Relative Weights and Average
Length of Stay Values for FY 2014
As specified in Sec. 412.620(b)(1), we calculate a relative weight
for each CMG that is proportional to the resources needed by an average
inpatient rehabilitation case in that CMG. For example, cases in a CMG
with a relative weight of 2, on average, will cost twice as much as
cases in a CMG with a relative weight of 1. Relative weights account
for the variance in cost per discharge due to the variance in resource
utilization among the payment groups, and their use helps to ensure
that IRF PPS payments support beneficiary access to care, as well as
provider efficiency.
In the FY 2014 IRF PPS proposed rule (78 FR 26880, 26885 through
26888), we proposed to update the CMG relative weights and average
length of stay values for FY 2014. As required by statute, we always
use the most recent available data to update the CMG relative weights
and average lengths of stay. For FY 2014, we proposed to use the FY
2012 IRF claims and FY 2011 IRF cost report data. These data are the
most current and complete data available at this time. Currently, only
a small portion of the FY 2012 IRF cost report data are available for
analysis, but the majority of the FY 2012 IRF claims data are available
for analysis.
In the FY 2014 IRF PPS proposed rule (78 FR 26880, 26885 through
26888), we proposed to apply these data using the same methodologies
that we have used to update the CMG relative weights and average length
of stay values in the FY 2011 notice (75 FR 42836), the FY 2012 final
rule (76 FR 47836), and the FY 2013 notice (77 FR 44618). In
calculating the CMG relative weights, we use a hospital-specific
relative value method to estimate operating (routine and ancillary
services) and capital costs of IRFs. The process used to calculate the
CMG relative weights is as follows:
Step 1. We estimate the effects that comorbidities have on costs.
Step 2. We adjust the cost of each Medicare discharge (case) to
reflect the effects found in the first step.
Step 3. We use the adjusted costs from the second step to calculate
CMG relative weights, using the hospital-specific relative value
method.
Step 4. We normalize the FY 2014 CMG relative weights to the same
average CMG relative weight from the CMG relative weights implemented
in the July 30, 2012 FY 2013 IRF PPS notice (77 FR 44618).
Consistent with the methodology that we have used to update the IRF
classification system in each instance in the past, we proposed to
update the CMG relative weights for FY 2014 in such a way that total
estimated aggregate payments to IRFs for FY 2014 are the same with or
without the changes (that is, in a budget-neutral manner) by applying a
budget neutrality factor to the standard payment amount. To calculate
the appropriate budget neutrality factor for use in updating the FY
2014 CMG relative weights, we use the following steps:
Step 1. Calculate the estimated total amount of IRF PPS payments
for FY 2014 (with no changes to the CMG relative weights).
Step 2. Calculate the estimated total amount of IRF PPS payments
for FY 2014 by applying the changes to the CMG relative weights (as
discussed above).
Step 3. Divide the amount calculated in step 1 by the amount
calculated in step 2 to determine the budget neutrality factor (1.0000)
that would maintain the same total estimated aggregate payments in FY
2014 with and without the changes to the CMG relative weights.
Step 4. Apply the budget neutrality factor (1.0000) to the FY 2013
IRF PPS standard payment amount after the application of the budget-
neutral wage adjustment factor.
In section VI.E. of this final rule, we discuss the use of the
existing methodology to calculate the standard payment conversion
factor for FY 2014.
Table 1, ``Relative Weights and Average Length of Stay Values for
Case-Mix Groups,'' presents the CMGs, the comorbidity tiers, the
corresponding relative weights, and the average length of stay values
for each CMG and tier for FY 2014. The average length of stay for each
CMG is used to determine when an IRF discharge meets the definition of
a short-stay transfer, which results in a per diem case level
adjustment.
[[Page 47866]]
Table 1--Relative Weights and Average Length of Stay Values for Case-Mix Groups
----------------------------------------------------------------------------------------------------------------
CMG Description Relative weight Average length of stay
(M = motor, C = -------------------------------------------------------------------------------
CMG cognitive, A =
age) Tier 1 Tier 2 Tier 3 None Tier 1 Tier 2 Tier 3 None
----------------------------------------------------------------------------------------------------------------
0101.......... Stroke M > 51.05 0.7983 0.7151 0.6539 0.6239 9 9 9 8
0102.......... Stroke M > 44.45 0.9911 0.8878 0.8118 0.7745 11 12 10 10
and M < 51.05
and C > 18.5.
0103.......... Stroke M > 44.45 1.1608 1.0398 0.9508 0.9071 13 13 12 11
and M < 51.05
and C < 18.5.
0104.......... Stroke M > 38.85 1.2212 1.0939 1.0002 0.9543 13 12 12 12
and M < 44.45.
0105.......... Stroke M > 34.25 1.4275 1.2787 1.1692 1.1155 15 15 14 14
and M < 38.85.
0106.......... Stroke M > 30.05 1.6285 1.4588 1.3339 1.2726 16 17 16 15
and M < 34.25.
0107.......... Stroke M > 26.15 1.8385 1.6468 1.5059 1.4367 19 20 17 17
and M < 30.05.
0108.......... Stroke M < 26.15 2.3157 2.0743 1.8967 1.8096 22 24 22 21
and A > 84.5.
0109.......... Stroke M > 22.35 2.0990 1.8802 1.7192 1.6403 21 21 19 20
and M < 26.15
and A < 84.5.
0110.......... Stroke M < 22.35 2.7382 2.4527 2.2427 2.1398 29 28 25 25
and A < 84.5.
0201.......... Traumatic brain 0.8252 0.6953 0.6182 0.5757 10 10 8 8
injury M >
53.35 and C >
23.5.
0202.......... Traumatic brain 1.0549 0.8889 0.7904 0.7360 12 10 10 10
injury M >
44.25 and M <
53.35 and C >
23.5.
0203.......... Traumatic brain 1.2520 1.0550 0.9380 0.8735 15 13 12 11
injury M >
44.25 and C <
23.5.
0204.......... Traumatic brain 1.3077 1.1020 0.9798 0.9124 12 13 12 12
injury M >
40.65 and M <
44.25.
0205.......... Traumatic brain 1.5791 1.3307 1.1831 1.1017 17 16 14 14
injury M >
28.75 and M <
40.65.
0206.......... Traumatic brain 1.9472 1.6409 1.4589 1.3585 18 19 18 16
injury M >
22.05 and M <
28.75.
0207.......... Traumatic brain 2.5767 2.1713 1.9305 1.7977 33 26 21 20
injury M <
22.05.
0301.......... Non-traumatic 1.0984 0.9453 0.8469 0.7832 10 11 11 10
brain injury M
> 41.05.
0302.......... Non-traumatic 1.3755 1.1838 1.0606 0.9808 13 14 12 12
brain injury M
> 35.05 and M <
41.05.
0303.......... Non-traumatic 1.6219 1.3958 1.2506 1.1565 17 16 14 14
brain injury M
> 26.15 and M <
35.05.
0304.......... Non-traumatic 2.1792 1.8755 1.6803 1.5539 24 21 19 18
brain injury M
< 26.15.
0401.......... Traumatic spinal 1.1342 0.9427 0.8778 0.7849 12 12 11 10
cord injury M >
48.45.
0402.......... Traumatic spinal 1.4129 1.1744 1.0936 0.9778 18 14 15 12
cord injury M >
30.35 and M <
48.45.
0403.......... Traumatic spinal 2.3155 1.9246 1.7921 1.6024 26 24 20 20
cord injury M >
16.05 and M <
30.35.
0404.......... Traumatic spinal 4.2535 3.5355 3.2921 2.9436 47 41 36 35
cord injury M <
16.05 and A >
63.5.
0405.......... Traumatic spinal 3.4992 2.9086 2.7083 2.4216 37 32 33 27
cord injury M <
16.05 and A <
63.5.
0501.......... Non-traumatic 0.8384 0.6587 0.6208 0.5653 9 9 8 8
spinal cord
injury M >
51.35.
0502.......... Non-traumatic 1.1090 0.8712 0.8211 0.7477 12 11 10 10
spinal cord
injury M >
40.15 and M <
51.35.
0503.......... Non-traumatic 1.4334 1.1261 1.0613 0.9664 15 13 13 12
spinal cord
injury M >
31.25 and M <
40.15.
0504.......... Non-traumatic 1.6565 1.3014 1.2265 1.1168 14 16 14 14
spinal cord
injury M >
29.25 and M <
31.25.
0505.......... Non-traumatic 1.9708 1.5483 1.4592 1.3287 21 18 17 16
spinal cord
injury M >
23.75 and M <
29.25.
0506.......... Non-traumatic 2.7518 2.1619 2.0375 1.8553 30 25 23 22
spinal cord
injury M <
23.75.
0601.......... Neurological M > 0.9645 0.7830 0.7227 0.6551 10 10 9 9
47.75.
0602.......... Neurological M > 1.2974 1.0533 0.9721 0.8811 12 12 11 11
37.35 and M <
47.75.
0603.......... Neurological M > 1.6228 1.3174 1.2159 1.1021 15 15 14 13
25.85 and M <
37.35.
0604.......... Neurological M < 2.1683 1.7603 1.6246 1.4726 22 19 18 17
25.85.
0701.......... Fracture of 0.9369 0.7995 0.7648 0.6945 10 10 10 9
lower extremity
M > 42.15.
0702.......... Fracture of 1.2132 1.0353 0.9904 0.8993 12 12 12 11
lower extremity
M > 34.15 and M
< 42.15.
0703.......... Fracture of 1.4741 1.2579 1.2033 1.0927 15 15 14 13
lower extremity
M > 28.15 and M
< 34.15.
0704.......... Fracture of 1.8716 1.5971 1.5278 1.3874 18 18 18 17
lower extremity
M < 28.15.
0801.......... Replacement of 0.7037 0.6193 0.5667 0.5186 7 8 7 7
lower extremity
joint M > 49.55.
0802.......... Replacement of 0.9255 0.8145 0.7454 0.6821 10 10 9 9
lower extremity
joint M > 37.05
and M < 49.55.
0803.......... Replacement of 1.2589 1.1078 1.0138 0.9277 12 14 13 12
lower extremity
joint M > 28.65
and M < 37.05
and A > 83.5.
0804.......... Replacement of 1.1139 0.9803 0.8971 0.8209 11 12 11 10
lower extremity
joint M > 28.65
and M < 37.05
and A < 83.5.
[[Page 47867]]
0805.......... Replacement of 1.3754 1.2104 1.1077 1.0136 15 15 13 12
lower extremity
joint M > 22.05
and M < 28.65.
0806.......... Replacement of 1.6683 1.4682 1.3435 1.2294 17 17 15 15
lower extremity
joint M < 22.05.
0901.......... Other orthopedic 0.9010 0.7452 0.6891 0.6241 10 9 9 8
M > 44.75.
0902.......... Other orthopedic 1.2081 0.9992 0.9241 0.8369 13 12 11 11
M > 34.35 and M
< 44.75.
0903.......... Other orthopedic 1.5080 1.2472 1.1534 1.0446 15 15 14 13
M > 24.15 and M
< 34.35.
0904.......... Other orthopedic 1.9669 1.6268 1.5045 1.3626 20 19 17 16
M < 24.15.
1001.......... Amputation, 1.0276 0.9345 0.8023 0.7417 12 11 10 10
lower extremity
M > 47.65.
1002.......... Amputation, 1.3077 1.1892 1.0210 0.9439 13 13 12 12
lower extremity
M > 36.25 and M
< 47.65.
1003.......... Amputation, 1.9362 1.7608 1.5117 1.3975 19 20 17 16
lower extremity
M < 36.25.
1101.......... Amputation, non- 1.2199 1.1157 1.0302 1.0056 13 13 12 12
lower extremity
M > 36.35.
1102.......... Amputation, non- 1.7115 1.5652 1.4454 1.4107 16 17 16 17
lower extremity
M < 36.35.
1201.......... Osteoarthritis M 0.9454 0.9411 0.8445 0.7724 9 11 10 10
> 37.65.
1202.......... Osteoarthritis M 1.1749 1.1695 1.0495 0.9599 14 14 13 12
> 30.75 and M <
37.65.
1203.......... Osteoarthritis M 1.4677 1.4609 1.3110 1.1991 13 18 15 14
< 30.75.
1301.......... Rheumatoid, 1.1678 0.9974 0.9062 0.8219 12 10 11 10
other arthritis
M > 36.35.
1302.......... Rheumatoid, 1.5025 1.2832 1.1659 1.0575 16 15 14 13
other arthritis
M > 26.15 and M
< 36.35.
1303.......... Rheumatoid, 1.9254 1.6444 1.4941 1.3551 18 18 17 16
other arthritis
M < 26.15.
1401.......... Cardiac M > 0.8869 0.7263 0.6555 0.5937 9 9 8 8
48.85.
1402.......... Cardiac M > 1.1928 0.9768 0.8816 0.7985 12 11 11 10
38.55 and M <
48.85.
1403.......... Cardiac M > 1.4581 1.1941 1.0777 0.9761 14 14 12 12
31.15 and M <
38.55.
1404.......... Cardiac M < 1.8587 1.5222 1.3738 1.2443 19 17 15 14
31.15.
1501.......... Pulmonary M > 1.0128 0.8635 0.7803 0.7474 10 9 9 9
49.25.
1502.......... Pulmonary M > 1.2651 1.0787 0.9747 0.9336 12 12 11 11
39.05 and M <
49.25.
1503.......... Pulmonary M > 1.5357 1.3094 1.1832 1.1333 15 14 13 13
29.15 and M <
39.05.
1504.......... Pulmonary M < 1.9057 1.6248 1.4683 1.4063 21 17 16 15
29.15.
1601.......... Pain syndrome M 1.0707 0.8883 0.8327 0.7639 9 10 10 9
> 37.15.
1602.......... Pain syndrome M 1.3889 1.1523 1.0802 0.9909 12 14 12 12
> 26.75 and M <
37.15.
1603.......... Pain syndrome M 1.7566 1.4573 1.3662 1.2533 18 17 15 15
< 26.75.
1701.......... Major multiple 1.1053 0.9551 0.8619 0.7769 11 12 11 10
trauma without
brain or spinal
cord injury M >
39.25.
1702.......... Major multiple 1.3905 1.2016 1.0843 0.9774 13 15 13 12
trauma without
brain or spinal
cord injury M >
31.05 and M <
39.25.
1703.......... Major multiple 1.6553 1.4304 1.2908 1.1635 17 16 15 14
trauma without
brain or spinal
cord injury M >
25.55 and M <
31.05.
1704.......... Major multiple 2.1005 1.8152 1.6380 1.4764 24 20 18 18
trauma without
brain or spinal
cord injury M <
25.55.
1801.......... Major multiple 1.1378 1.0183 0.9216 0.7648 13 12 12 10
trauma with
brain or spinal
cord injury M >
40.85.
1802.......... Major multiple 1.7508 1.5669 1.4182 1.1769 18 19 17 14
trauma with
brain or spinal
cord injury M >
23.05 and M <
40.85.
1803.......... Major multiple 2.7973 2.5035 2.2659 1.8804 33 28 24 22
trauma with
brain or spinal
cord injury M <
23.05.
1901.......... Guillain Barre M 1.0836 0.9288 0.8847 0.8716 14 10 11 11
> 35.95.
1902.......... Guillain Barre M 2.1258 1.8221 1.7355 1.7097 23 21 19 20
> 18.05 and M <
35.95.
1903.......... Guillain Barre M 3.5333 3.0287 2.8846 2.8418 56 32 31 30
< 18.05.
2001.......... Miscellaneous M 0.8877 0.7267 0.6691 0.6107 9 9 8 8
> 49.15.
2002.......... Miscellaneous M 1.1867 0.9714 0.8945 0.8164 12 11 11 10
> 38.75 and M <
49.15.
2003.......... Miscellaneous M 1.4947 1.2235 1.1266 1.0283 15 14 13 12
> 27.85 and M <
38.75.
2004.......... Miscellaneous M 1.9610 1.6051 1.4780 1.3490 20 18 17 15
< 27.85.
2101.......... Burns M > 0..... 2.1953 1.5624 1.5111 1.4146 24 21 17 17
5001.......... Short-stay ........ ........ ........ 0.1538 ........ ........ ........ 3
cases, length
of stay is 3
days or fewer.
5101.......... Expired, ........ ........ ........ 0.6617 ........ ........ ........ 8
orthopedic,
length of stay
is 13 days or
fewer.
5102.......... Expired, ........ ........ ........ 1.4346 ........ ........ ........ 17
orthopedic,
length of stay
is 14 days or
more.
5103.......... Expired, not ........ ........ ........ 0.7653 ........ ........ ........ 8
orthopedic,
length of stay
is 15 days or
fewer.
5104.......... Expired, not ........ ........ ........ 1.9685 ........ ........ ........ 21
orthopedic,
length of stay
is 16 days or
more.
----------------------------------------------------------------------------------------------------------------
Generally, updates to the CMG relative weights result in some
increases and some decreases to the CMG relative weight values. Table 2
shows how the application of the revisions for FY 2014 will affect
particular CMG relative
[[Page 47868]]
weight values, which affect the overall distribution of payments within
CMGs and tiers. Note that, because we are implementing the CMG relative
weight revisions in a budget-neutral manner (as described above), total
estimated aggregate payments to IRFs for FY 2014 will not be affected
as a result of the CMG relative weight revisions. However, the
revisions will affect the distribution of payments within CMGs and
tiers.
Table 2--Distributional Effects of the Changes to the CMG Relative
Weights (FY 2013 Values Compared With FY 2014 Values)
------------------------------------------------------------------------
Number of cases Percentage of
Percentage change affected cases affected
------------------------------------------------------------------------
Increased by 15% or more............ 0 0.0
Increased by between 5% and 15%..... 2,492 0.7
Changed by less than 5%............. 363,629 98.7
Decreased by between 5% and 15%..... 2,118 0.6
Decreased by 15% or more............ 97 0.0
------------------------------------------------------------------------
As Table 2 shows, almost 99 percent of all IRF cases are in CMGs
and tiers that will experience less than a 5 percent change (either
increase or decrease) in the CMG relative weight value as a result of
the revisions for FY 2014. The largest increase in the CMG relative
weight values that affects a particularly large number of IRF
discharges is a 0.8 percent increase in the CMG relative weight value
for CMG 0704--Fracture of Lower Extremity, with a motor score less than
28.15--in the ``no comorbidity'' tier. In the FY 2012 data, 19,981 IRF
discharges (5.4 percent of all IRF discharges) were classified into
this CMG and tier.
The largest decrease in a CMG relative weight value affecting the
most cases is a 2.1 percent decrease in the CMG relative weight for CMG
0903--Other Orthopedic with a motor score between 24.15 and 34.35--in
the no comorbidity tier. In the FY 2012 IRF claims data, this change
affects 7,047 cases (1.9 percent of all IRF cases).
The changes in the average length of stay values for FY 2014,
compared with the FY 2013 average length of stay values, are small and
do not show any particular trends in IRF length of stay patterns.
We received 3 comments on the proposed updates to the CMG relative
weights and average length of stay values for FY 2014, which are
summarized below.
Comment: Several commenters supported the use of the same
methodology that we used in the FY 2011 notice, the FY 2012 final rule,
and the FY 2013 notice to update the CMG relative weights and average
length of stay values for FY 2014, using the most recent available
data. However, one commenter expressed concern about changes to some of
the specific CMG relative weights, indicating that some of the changes
were not necessary and that others might affect whether or not the CMGs
would be adequately compensating providers for treating certain types
of patients requiring unusually high-cost treatments.
Response: We believe that updating the relative weights using the
most recent available data ensures that the payments per case continue
to accurately reflect the costs of care provided in IRFs. Although we
acknowledge the commenter's concerns with some of the specific CMG
relative weight changes, these changes are based on IRFs' reported
costs of care for these types of cases, and we believe that it is
essential to recognize these reported costs to ensure that the CMG
relative weights reflect as closely as possible the relative costs of
treating different types of patients in IRFs. Further, we note that the
IRF PPS high-cost outlier policy is designed to compensate IRFs for
providing care to patients whose costs greatly exceed the average cost
of a case in a particular CMG and tier.
Comment: A few commenters requested that we outline the methodology
used to calculate the average length of stay values. These same
commenters agreed that the average length of stay values should only be
used to determine when an IRF discharge meets the definition of a
short-stay transfer, which results in a per diem case level adjustment,
and are not intended to be used as clinical guidelines for patients'
lengths of stay in an IRF.
Response: We will post our methodology for calculating the average
length of stay values on the IRF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Research.html in conjunction with the publication of this final rule.
We continue to support the commenters' position that the average
length of stay values in the rule are not intended as ``targets'' or as
clinical guidelines for determining a patient's length of stay in the
IRF. A patient's length of stay in the IRF should be determined by the
patient's individual care needs.
Final Decision: After careful consideration of the public comments,
we are finalizing our proposal to update the CMG relative weight and
average length of stay values for FY 2014. These updates are effective
October 1, 2013.
V. Updates to the Facility-Level Adjustment Factors for FY 2014
A. Background on Facility-Level Adjustments
Section 1886(j)(3)(A)(v) of the Act confers broad authority upon
the Secretary to adjust the per unit payment rate ``by such . . .
factors as the Secretary determines are necessary to properly reflect
variations in necessary costs of treatment among rehabilitation
facilities.'' For example, we adjust the federal prospective payment
amount associated with a CMG to account for facility-level
characteristics such as an IRF's LIP, teaching status, and location in
a rural area, if applicable, as described in Sec. 412.624(e).
In the FY 2010 IRF PPS final rule (74 FR 39762), we updated the
adjustment factors for calculating the rural, LIP, and teaching status
adjustments based on the most recent three consecutive years' worth of
IRF claims data (at that time, FY 2006, FY 2007, and FY 2008) and the
most recent available corresponding IRF cost report data. As discussed
in the FY 2010 IRF PPS proposed rule (74 FR 21060 through 21061), we
observed relatively large year-to-year fluctuations in the underlying
data used to compute the adjustment factors, especially the teaching
status adjustment factor. Therefore, we implemented a 3-year moving
average approach to updating the facility-level adjustment factors in
the FY 2010 IRF PPS final rule (74 FR 39762) to provide greater
stability and predictability of Medicare payments for IRFs.
[[Page 47869]]
Each year, we review the major components of the IRF PPS to
maintain and enhance the accuracy of the payment system. For FY 2010,
we implemented a change to our methodology that was designed to
decrease the IRF PPS volatility by using a 3-year moving average to
calculate the facility-level adjustment factors. For FY 2011, we issued
a notice to update the payment rates, which did not include any policy
changes or changes to the IRF facility-level adjustments. As we found
that the implementation of the 3-year moving average did not fully
address year-to-year fluctuations, in the FY 2012 IRF PPS proposed rule
(76 FR 24214 at 24225 through 24226) we analyzed the effects of having
used a weighting methodology. The methodology assigned greater weight
to some facilities than to others in the regression analysis used to
estimate the facility-level adjustment factors. As we found that this
weighting methodology inappropriately exaggerated the cost differences
among different types of IRF facilities, we proposed to remove the
weighting factor from our analysis and update the IRF facility-level
adjustment factors for FY 2012 using an un-weighted regression
analysis. However, after carefully considering all of the comments that
we received on the proposed FY 2012 updates to the facility-level
adjustment factors, we decided to hold the facility-level adjustment
factors at FY 2011 levels for FY 2012 to conduct further research on
the underlying data and the best methodology for calculating the
facility-level adjustment factors. We based this decision, in part, on
comments we received about the financial hardships that the proposed
updates would create for facilities with teaching programs and a higher
disproportionate share of low-income patients.
B. Updates to the IRF Facility-Level Adjustment Factors
Since the FY 2012 final rule (76 FR 47836), we have conducted
further research into the best methodology to use to estimate the IRF
facility-level adjustment factors, to ensure that the adjustment
factors reflect as accurately as possible the costs of providing IRF
care across the full spectrum of IRF providers. Our recent research
efforts have shown that significant differences exist between the cost
structures of freestanding IRFs and the cost structures of IRF units of
acute care hospitals (and critical access hospitals, otherwise known as
``CAHs''). We have found that these cost structure differences
substantially influence the estimates of the adjustment factors.
Therefore, we believe that it is important to control for these cost
structure differences between hospital-based and freestanding IRFs in
our regression analysis, so that these differences do not
inappropriately influence the adjustment factor estimates. In
Medicare's payment system for the treatment of end-stage renal disease
(ESRD), we already control for the cost structure differences between
hospital-based and freestanding facilities in the regression analyses
that are used to set payment rates. Also, we received comments from an
IRF industry association on the FY 2012 IRF PPS proposed rule
suggesting that the addition of this particular control variable to the
model could improve the methodology for estimating the IRF facility-
level adjustment factors.
Thus, in the FY 2014 IRF PPS proposed rule, we proposed to add an
indicator variable to our 3-year moving average methodology for
updating the IRF facility-level adjustments that would have an assigned
value of ``1'' if the facility is a freestanding IRF hospital and have
an assigned value of ``0'' if the facility is an IRF unit of an acute
care hospital (or CAH). Adding this variable to the regression analysis
enables us to control for the differences in costs that are primarily
due to the differences in cost structures between freestanding and
hospital-based IRFs, so that those differences do not become
inappropriately intertwined with our estimates of the differences in
costs between rural and urban facilities, high LIP percentage and low
LIP percentage facilities, and teaching and non-teaching facilities.
Further, by including this variable in the regression analysis, we
greatly improve our ability to predict an IRF's average cost per case
(that is, the R-squared of the regression model increases from about 11
percent to about 41 percent). In this way, it enhances the precision
with which we can estimate the IRF facility-level adjustments.
Therefore, in the FY 2014 IRF PPS proposed rule, we proposed to use
the same methodology used in the FY 2010 IRF PPS final rule (74 FR
39762), including the 3-year moving average approach, with the addition
of this new control variable, which equals ``1'' if the facility is a
freestanding IRF hospital and ``0'' if it is an IRF unit of an acute
care hospital (or a CAH). We proposed to update the adjustment factors
using the most recent three years' worth of IRF claims data (FY 2010,
FY 2011, and FY 2012) and the most recent available corresponding IRF
cost report data. As we did in the FY 2010 IRF PPS final rule (74 FR
39762), we also proposed to use the cost report data that corresponds
with each IRF claim, when available. In the rare instances in which the
corresponding year's cost report data are not available, we proposed to
use the most recent available cost report data, as we also did in the
FY 2010 IRF PPS final rule (74 FR 39762).
To calculate the updates to the rural, LIP, and teaching status
adjustment factors for FY 2014, we use the following steps:
[Steps 1 and 2 are performed independently for each of three years
of IRF claims data: FY 2010, FY 2011, and FY 2012.]
Step 1. Calculate the average cost per case for each IRF in the IRF
claims data.
Step 2. Use logarithmic regression analysis on average cost per
case to compute the coefficients for the rural, LIP, and teaching
status adjustments. We proposed to incorporate an additional indicator
variable to account for whether a facility is a freestanding IRF
hospital or a unit of an acute care hospital (or a CAH).
Step 3. Calculate a simple mean for each of the coefficients across
the three years of data (using logarithms for the LIP and teaching
status adjustment coefficients (because they are continuous variables),
but not for the rural adjustment coefficient (because the rural
variable is either zero (if not rural) or 1 (if rural)). To compute the
LIP and teaching status adjustment factors, we convert these factors
back out of the logarithmic form.
Based on this methodology, we proposed to update the rural
adjustment factor for FY 2014 from 18.4 percent to 14.9 percent. We
proposed to update the LIP adjustment factor for FY 2014 from 0.4613 to
0.3177 and the teaching status adjustment factor for FY 2014 from
0.6876 to 1.0163.
C. Budget Neutrality Methodology for the Updates to the IRF Facility-
Level Adjustment Factors
Consistent with the way that we implemented changes to the IRF
facility-level adjustment factors (the rural, LIP, and teaching status
adjustments factors) in the FY 2006 IRF PPS final rule (70 FR 47880 and
70 FR 57166), which was the only year in which we updated these
adjustment factors, we proposed to make changes to the rural, LIP, and
teaching status adjustment factors for FY 2014 in such a way that total
estimated aggregate payments to IRFs for FY 2014 would be the same with
or without the proposed changes (that is, in a budget-neutral manner)
by applying budget neutrality factors for each of these three changes
to the standard payment amount. To calculate the budget neutrality
factors used to update the rural, LIP, and teaching status
[[Page 47870]]
adjustment factors, we use the following steps:
Step 1. Using the most recent available data (currently FY 2012),
calculate the estimated total amount of IRF PPS payments that would be
made in FY 2014 (without applying the changes to the rural, LIP, or
teaching status adjustment factors).
Step 2. Calculate the estimated total amount of IRF PPS payments
that will be made in FY 2014 if the update to the rural adjustment
factor were applied.
Step 3. Divide the amount calculated in step 1 by the amount
calculated in step 2 to determine the budget neutrality factor (1.0025)
that will maintain the same total estimated aggregate payments in FY
2014 with and without the change to the rural adjustment factor.
Step 4. Calculate the estimated total amount of IRF PPS payments
that will be made in FY 2014 if the update to the LIP adjustment factor
were applied.
Step 5. Divide the amount calculated in step 1 by the amount
calculated in step 4 to determine the budget neutrality factor (1.0171)
that will maintain the same total estimated aggregate payments in FY
2014 with and without the change to the LIP adjustment factor.
Step 6. Calculate the estimated total amount of IRF PPS payments
that will be made in FY 2014 if the update to the teaching status
adjustment factor were applied.
Step 7. Divide the amount calculated in step 1 by the amount
calculated in step 6 to determine the budget neutrality factor (0.9962)
that will maintain the same total estimated aggregate payments in FY
2014 with and without the change to the teaching status adjustment
factor.
Step 8. Apply the budget neutrality factors for the updates to the
rural, LIP, and teaching status adjustment factors to the FY 2013 IRF
PPS standard payment amount after the application of the budget
neutrality factors for the wage adjustment and the CMG relative
weights.
In section VI.E. of this final rule, we discuss the methodology for
calculating the standard payment conversion factor for FY 2014.
We received 19 comments on the proposed updates to the facility-
level adjustment factors, which are summarized below.
Comment: Several commenters expressed concerns about the financial
impact that the reductions to the rural and LIP adjustments would have
on individual IRFs. These commenters also expressed concerns about the
potential effects of this policy change combined with possible state
Medicaid expansions under the Affordable Care Act. These commenters
suggested that we delay implementation until FY 2015, phase in the
updates over multiple years, or implement a stop-loss policy to
mitigate the financial impact of the changes.
Response: Although we are mindful of the significant financial
impacts on a small number of individual IRFs of finalizing these
proposals, we believe that updating the facility level adjustments as
proposed is necessary at this time to ensure that the adjustment
factors reflect as accurately as possible the costs of providing IRF
care across the full spectrum of IRF providers. In addition, we
estimate that the maximum financial impact on any one facility from
these proposed policy changes is similar to the financial impact that
can result from annual fluctuations in the geographic wage index
values, and we do not typically implement a delay or phase-in period to
account for annual wage index fluctuations.
Although we understand that providers are subject to multiple
financial pressures in today's economic climate, the policies
established by this final rule are focused on providing accurate
payment for Medicare Part A services provided in an IRF setting.
However, we note that, to the extent that Medicaid coverage is expanded
under the Affordable Care Act provisions, we believe that this could
increase IRFs' LIP percentages, potentially leading to higher LIP
adjustment payments under the IRF PPS. We do not believe that such
potential increases in spending for the LIP adjustment undercut the
need to ensure that LIP adjustment payments are as fair and accurate as
possible for FY 2014.
Further, whereas the proposed updates to the facility-level
adjustment factors would decrease payments to some IRFs, they would
increase payments to other IRFs, by as much as 16.8 percent. By
updating the facility-level adjustment factors with the proposed
methodology, we ensure that the adjustment factors reflect as
accurately as possible the costs of providing IRF care across the full
spectrum of IRF providers where individual providers may see an
increase or decrease. In addition, because we update the rural and LIP
adjustments in a budget-neutral manner, decreases to these adjustments
result in increases to the base payment rates for all IRF providers,
partially offsetting some of the decreases in the rural and LIP
adjustment payments for the affected providers. Thus, we believe it is
necessary to update the adjustments at this time, using the proposed
new enhancement to the methodology, to pay providers as accurately and
fairly as possible.
Comment: Several commenters did not support our proposal to include
an indicator variable for an IRF's freestanding/hospital-based status
in the regression model, based on their belief that such variables
should only be included if they are used as payment adjusters. These
commenters further suggested that CMS pursue further analysis to
explain the fluctuations in the teaching status adjustment factor over
time. One commenter recommended that CMS cap the IRF teaching status
adjustment factor at the same level as the IPPS IME adjustment, the IPF
teaching status adjustment, or some combination of these adjustments.
Response: We appreciate the commenters' concerns and
recommendations. However, given that our analysis showed large
differences in cost structures between freestanding and hospital-based
IRFs, and that a significant amount of the differences in costs between
different types of IRFs (for example, urban/rural, teaching/non-
teaching, and high LIP percentage/low LIP percentage) can be attributed
instead to a facility's freestanding/hospital-based status, we believe
that we would be remiss in not accounting for this indicator variable
in the regression analysis. Thus, we believe that the inclusion of the
indicator variable enables us to more precisely and accurately
calculate each of the facility-level adjustment factors.
For several reasons, however, we do not believe that a facility's
freestanding/hospital-based status can be used as a payment adjuster at
this time. First, we do not know how much of the higher costs we
observe in hospital-based IRFs can be attributed to the actual costs of
treating patients in hospital-based settings (versus freestanding
settings) and how much of the higher costs result from a hospital's
decisions about allocating costs among its different components.
Secondly, the IRF PPS has traditionally treated freestanding IRF
hospitals and IRF units of acute care hospitals (or CAHs) the same for
Medicare payment purposes. Thus, we do not believe it is appropriate to
introduce a freestanding/hospital-based payment adjuster for the IRF
PPS without substantial evidence that a change in policy is warranted
at this time. However, we do believe that it is necessary to recognize
the important differences in cost structures of the two types of
facilities in order to pay IRFs as accurately and fairly as possible
under the IRF PPS.
[[Page 47871]]
As one commenter suggested, we have done extensive analysis to
uncover the reasons for the fluctuations in the IRF teaching status
adjustment factor over time. Our analysis shows that such fluctuations
are related primarily to the fact that there are relatively few IRF
teaching facilities (around 110 in each year), and therefore
fluctuations in the teaching status of one or two of these IRFs will be
evident in overall fluctuations in the teaching adjustment factor over
time. Specifically, we found that one IRF did not report training any
interns and residents from 2007 through 2009, then reported relatively
large intern and resident to average daily census ratios in 2010 and
2011, and then did not report training any interns and residents after
2011. This one provider appears to have contributed to swings in the
overall teaching status adjustment factor over time. However, we have
no reason to believe that any of the teaching status information for
this provider is incorrect, and therefore believe that including this
data is appropriate.
Further, our analysis of the IRF teaching adjustment trends shows
no significant cause for concern in terms of unusually high or
increasing Medicare payments for this adjustment over time. We found
that the number of IRFs receiving this adjustment and the Medicare
payments per IRF for this adjustment have remained very stable over
time. Total Medicare spending for the IRF teaching adjustment peaked at
$78 million (almost 9 percent of total IRF PPS payments) for 124
facilities in FY 2006, and fell to $56 million (6 percent of total IRF
PPS payments) for 111 facilities in FY 2012. The average Medicare
payment to an individual IRF for the teaching status adjustment
decreased from $773,000 in FY 2006 to $508,000 in FY 2012. The average
number of interns and residents relative to an IRF's average daily
census (the factor on which an IRF's teaching status adjustment is
based) was 0.12 in FY 2006, and declined to 0.11 in FY 2012. Given the
small magnitude of the IRF teaching status adjustment relative to total
IRF expenditures, the lack of growth in spending for this adjustment,
and the need to ensure that IRFs are adequately compensated for
training a new generation of physicians in the rehabilitation of
Medicare beneficiaries in the IRF setting, we believe that continued
funding of this adjustment is beneficial to the Medicare program and
Medicare beneficiaries.
As one commenter suggested, we explored the possibility of capping
the IRF teaching status adjustment at the level of either the IPPS
capital or operating IME adjustments. However, either of these options
would decrease the IRF teaching status adjustment factor to such an
extremely low level (0.03 or 0.04 compared with the current 0.6876)
that the additional payment per facility would not be enough to
adequately compensate or encourage the training of a new generation of
physicians in the rehabilitation of Medicare beneficiaries in the IRF
setting. While capping the adjustment at the amount currently reflected
in the inpatient psychiatric facility teaching status adjustment
(0.5150) would seem to provide greater compensation than capping at
either the IPPS capital or operating IME adjustment levels, at this
time there is not enough evidence to believe that teaching costs or
compensation should be the same for these settings. In fact, inpatient
psychiatric facilities are not similar to IRFs in the types of patients
they treat or the types of services they provide, so we cannot find any
logical justification for capping the IRF teaching status adjustment
factor at the teaching status adjustment factor used in the IPF PPS.
Comment: One commenter requested clarification on the 3-year moving
average approach, including how the approach is used and whether or not
the IRF area wage index adjustment is included as one of the
adjustments that we estimate using this approach.
Response: The 3-year moving average approach was implemented to
decrease year-to-year fluctuations in the facility-level adjustment
factors. The IRF area wage index adjustment is not included in the
facility-level adjustments that we estimate using a 3-year moving
average approach.
Comment: Several commenters requested more information about the
methodology used to compute the IRF facility-level adjustments, and the
data to enable providers to replicate our analysis. In addition, one
commenter requested that we provide the estimates that were averaged
over the 3-year period to obtain the facility-level adjustment factors,
and that we run our regression analysis on three years' worth of pooled
discharge data instead of averaging each year's regression coefficients
over three years.
Response: Our regression analysis for computing the IRF facility-
level adjustments was posted on the IRF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/Facility-Payment-Adjustment_KJS.pdf in
2011. As we discussed in the proposed rule, the only change to this
regression analysis would be the addition of an indicator variable for
an IRF's freestanding/hospital-based status, which would equal ``1'' if
the IRF was a freestanding facility and ``0'' if the IRF was a
hospital-based facility. The data that we used to analyze the
adjustments is available from the IRF rate-setting files on the IRF PPS
Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html. The annual IRF facility-
level adjustment factor estimates are presented below in Table 3. For
this final rule, we averaged the estimates for FY 2010, FY 2011, and FY
2012.
Table 3--Annual IRF Facility-Level Adjustment Factor Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 05 FY 06 FY 07 FY 08 FY 09 FY 10 FY 11 FY 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
LIP............................................................. 0.4172 0.5107 0.3865 0.4898 0.4866 0.1594 0.2702 0.5538
Teaching........................................................ 1.5155 0.6732 1.0451 0.4045 1.5678 0.3597 0.6326 2.6930
Rural........................................................... 0.1860 0.1856 0.1765 0.1898 0.2123 0.1608 0.1516 0.1356
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additionally, we investigated another commenter's suggestion that
we reduce the annual fluctuation in the adjustment factors by
performing the regression analysis on three years' worth of pooled
discharge data instead of averaging each year's regression coefficients
over three years. We tried the approach that the commenter suggested,
and it did not materially change our estimates.
Final Decision: After careful consideration of the public comments,
we are finalizing our proposal to add an indicator variable for a
facility's freestanding/hospital-based status to the payment
regression, and, with that change, to update the IRF facility-level
adjustment factors for FY 2014 using the same methodology, with the
exception of adding the indicator variable, that we used in updating
the FY 2010 IRF
[[Page 47872]]
facility-level adjustment factors, including the 3-year moving average
approach. This results in a rural adjustment of 14.9 percent, a LIP
adjustment factor of 0.3177, and a teaching status adjustment factor of
1.0163 for FY 2014. These updates are effective October 1, 2013.
VI. FY 2014 IRF PPS Federal Prospective Payment Rates
A. Market Basket Increase Factor, Productivity Adjustment, and Other
Adjustment for FY 2014
Section 1886(j)(3)(C) of the Act requires the Secretary to
establish an increase factor that reflects changes over time in the
prices of an appropriate mix of goods and services included in the
covered IRF services, which is referred to as a market basket index.
According to section 1886(j)(3)(A)(i) of the Act, the increase factor
shall be used to update the IRF federal prospective payment rates for
each FY. Sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(iii) of the
Act required the application of a 0.3 percentage point reduction to the
market basket increase factor for FY 2014. In addition, section
1886(j)(3)(C)(ii)(I) of the Act requires the application of a
productivity adjustment, as described below. Thus, in the FY 2014 IRF
PPS proposed rule, we proposed to update the IRF PPS payments for FY
2014 by a market basket increase factor based upon the most current
data available, with a productivity adjustment as required by section
1886(j)(3)(C)(ii)(I) of the Act as described below and a 0.3 percentage
point reduction as required by sections 1886(j)(3)(C)(ii)(II) and
1886(j)(3)(D)(iii) of the Act.
For this final rule, we use the same methodology described in the
FY 2012 IRF PPS final rule (76 FR 47836 at 47848 through 47863) to
compute the FY 2014 market basket increase factor and labor-related
share. In that final rule, we rebased the RPL market basket from a 2002
base year to a 2008 base year. Based on IHS Global Insight's second
quarter 2013 forecast, the most recent estimate of the 2008-based RPL
market basket increase factor for FY 2014 is 2.6 percent. IHS Global
Insight (IGI) is an economic and financial forecasting firm that
contracts with CMS to forecast the components of providers' market
baskets.
In accordance with section 1886(j)(3)(C)(ii)(I) of the Act, and
using the methodology described in the FY 2012 IRF PPS final rule (76
FR 47836, 47858 through 47859), we apply a productivity adjustment to
the FY 2014 RPL market basket increase factor. The statute defines the
productivity adjustment to be equal to the 10-year moving average of
changes in annual economy-wide private nonfarm business multifactor
productivity (MFP) (as projected by the Secretary for the 10-year
period ending with the applicable FY cost reporting period, or other
annual period) (the ``MFP adjustment''). The Bureau of Labor Statistics
(BLS) is the agency that publishes the official measure of private
nonfarm business MFP. We refer readers to the BLS Web site at https://www.bls.gov/mfp to obtain the historical BLS-published MFP data. The
projection of MFP is currently produced by IGI, using the methodology
described in the FY 2012 IRF PPS final rule (76 FR 47836, 47859). The
most recent estimate of the MFP adjustment for FY 2014 (the 10-year
moving average of MFP for the period ending FY 2014) is 0.5 percent,
which was calculated using the methodology described in the FY 2012 IRF
PPS final rule (76 FR 47836, 47858 through 47859) and is based on IGI's
second quarter 2013 forecast.
Thus, in accordance with section 1886(j)(3)(C) of the Act, we base
the FY 2014 market basket update, which is used to determine the
applicable percentage increase for the IRF payments, on the most recent
estimate of the FY 2008-based RPL market basket (currently estimated to
be 2.6 percent based on IGI's second quarter 2013 forecast). We then
reduce this percentage increase by the current estimate of the MFP
adjustment for FY 2014 of 0.5 percentage point (the 10-year moving
average of MFP for the period ending FY 2014 based on IGI's second
quarter 2013 forecast), which was calculated as described in the FY
2012 IRF PPS final rule (76 FR 47836, 47859). Following application of
the MFP, we further reduce the applicable percentage increase by 0.3
percentage point, as required by sections 1886(j)(3)(C)(ii)(II) and
1886(j)(3)(D)(iii) of the Act. Therefore, the current estimate of the
FY 2014 IRF update is 1.8 percent (2.6 percent market basket update,
less 0.5 percentage point MFP adjustment, less 0.3 percentage point
legislative adjustment).
B. Secretary's Final Recommendation
For FY 2014, the Medicare Payment Advisory Commission (MedPAC)
recommends that a 0 percent update be applied to IRF PPS payment rates.
As discussed above, and in accordance with sections 1886(j)(3)(C) and
1886(j)(3)(D) of the Act, the Secretary is proposing to update IRF PPS
payment rates for FY 2014 by an adjusted market basket increase factor
of 1.8 percent, as section 1886(j)(3)(C) of the Act does not provide
the Secretary with the authority to apply a different update factor to
IRF PPS payment rates for FY 2014.
We received 5 comments on the proposed market basket increase
factor, MFP adjustment, other adjustments for FY 2014, and the
Secretary's proposed recommendation, which are summarized below.
Comment: One commenter supported our proposal to update the IRF PPS
payment rates for FY 2014 by the adjusted market basket estimate.
Another commenter noted that MedPAC recommended a 0 percent update for
IRFs for FY 2014, but recognized that CMS does not have the statutory
authority to apply a different update factor to IRF PPS payment rates
than is specified in statute. Several other commenters expressed
concerns about the applicability of the MFP adjustment to the IRF
setting, indicating that the unique services provided in IRFs do not
lend themselves to the efficiency gains that are implied by the
application of a MFP adjustment. These commenters recommended that we
continue to monitor the impact of the MFP adjustment on IRFs and
communicate our findings to the Congress.
Response: We appreciate the commenters' concerns. As these
commenters noted, we are bound in these matters by the statute.
However, we will continue to monitor the effects of the annual updates
to the IRF PPS payment rates, and will communicate our findings as
appropriate.
Comment: One commenter expressed concern about our use of some of
the underlying cost categories, weights, and price proxies from the
acute care hospital data, when the necessary RPL-specific data are not
available, and suggested that we consider collecting additional
information on the IRF cost reports prior to our next rebasing of the
RPL market basket, so that we will not have to use the IPPS data for
this purpose anymore.
Response: As stated in the FY 2012 IRF final rule (76 FR 47836,
47851), effective for cost reports beginning on or after May 1, 2010,
we finalized a revised Hospital and Hospital Health Care Complex Cost
Report, Form CMS 2552-10, which includes a new worksheet (Worksheet S-
3, part V) which identifies the contract labor costs and benefit costs
for the hospital complex and is applicable to sub-providers and units.
Prior to any future rebasings, we plan to review any contract labor and
benefit cost data submitted by RPL providers to determine the
appropriateness of using this
[[Page 47873]]
information in the derivation of updated market basket cost weights.
Final Decision: After careful consideration of the public comments,
we are finalizing our decision to update IRF PPS payment rates for FY
2014 based on the most recent estimate of the FY 2008-based RPL market
basket (currently estimated to be 2.6 percent based on IGI's second
quarter 2013 forecast). We then reduce this percentage increase by the
current estimate of the MFP adjustment for FY 2014 of 0.5 percentage
point (the 10-year moving average of MFP for the period ending FY 2014
based on IGI's second quarter 2013 forecast), which was calculated as
described in the FY 2012 IRF PPS final rule (76 FR 47836, 47859).
Following application of the MFP adjustment, we further reduce the
applicable percentage increase by 0.3 percentage point, as required by
sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(iii) of the Act.
Therefore, the FY 2014 IRF update is 1.8 percent (2.6 percent market
basket update, less 0.5 percentage point MFP adjustment, less 0.3
percentage point legislative adjustment).
C. Labor-Related Share for FY 2014
The labor-related share for FY 2014 is updated using the
methodology described in the FY 2012 IRF PPS final rule (76 FR 47836,
47860 through 47863). Using this method and IGI's second quarter 2013
forecast of the 2008-based RPL market basket, the IRF labor-related
share for FY 2014 is the sum of the FY 2014 relative importance of each
labor-related cost category. This figure reflects the different rates
of price change for these cost categories between the base year (FY
2008) and FY 2014. As shown in Table 4, the FY 2014 labor-related share
is 69.494 percent.
Table 4--FY 2014 IRF RPL Labor-Related Share Relative Importance
------------------------------------------------------------------------
FY 2014 Relative
importance labor-
related share
------------------------------------------------------------------------
Wages and Salaries................................... 48.394
Employee Benefits.................................... 12.963
Professional Fees: Labor-Related..................... 2.065
Administrative and Business Support Services......... 0.415
All Other: Labor-Related Services.................... 2.080
Subtotal............................................. 65.917
Labor-Related Portion of Capital Costs (.46)......... 3.577
------------------
Total Labor-Related Share........................ 69.494
------------------------------------------------------------------------
Source: IHS Global Insight, Inc. 2nd quarter 2013 forecast; Historical
Data through 1st quarter, 2013.
We received 1 comment on the proposed update to the IRF labor-
related share, which is summarized below.
Comment: One commenter expressed general concern with the proposed
decrease in the IRF labor-related share from FY 2013 to FY 2014.
Response: We believe that the methodology for determining the
labor-related share is technically appropriate, as it estimates the
proportion of IRF costs that are labor-intensive and vary with, or are
influenced by, the local labor market. The methodology for determining
the proposed IRF labor-related share for FY 2014 is the same general
method that was used to derive the FY 2013 IRF PPS labor-related share.
That is, the labor-related share is equal to the sum of the relative
importance of each labor-related cost category in the RPL market
basket. We calculate the labor-related relative importance for FY 2014
in four steps. First, we compute the FY 2014 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
2014 price index level for that cost category by the total market
basket price index level. Third, we determine the FY 2014 relative
importance for each cost category by multiplying this ratio by the base
year (FY 2008) weight. Finally, we add the FY 2014 relative importance
for each of the labor-related cost categories. The purpose of the
relative importance is to capture the different rates of price change
for each of the market basket cost categories between the base year (FY
2008 for IRFs) and FY 2014. Therefore, to the extent an individual
price proxy for a specific cost category is projected to grow faster
from FY 2008 to FY 2014 relative to the proxies for other cost
categories, the relative importance for that category in FY 2014 will
be higher than the base year cost weight in FY 2008.
Final Decision: After consideration of the public comments
received, we are finalizing our decision to update IRF labor-related
share for FY 2014 using the methodology described in the FY 2012 IRF
PPS final rule (76 FR 47836, 47860 through 47863) and IGI's second
quarter 2013 forecast of the 2008-based RPL market basket. The FY 2014
labor-related share is 69.494 percent.
D. Wage Adjustment
Section 1886(j)(6) of the Act requires the Secretary to adjust the
proportion of rehabilitation facilities' costs attributable to wages
and wage related costs (as estimated by the Secretary from time to
time) by a factor (established by the Secretary) reflecting the
relative hospital wage level in the geographic area of the
rehabilitation facility compared to the national average wage level for
those facilities. The Secretary is required to update the IRF PPS wage
index on the basis of information available to the Secretary on the
wages and wage-related costs to furnish rehabilitation services. Any
adjustment or updates made under section 1886(j)(6) of the Act for a FY
are made in a budget-neutral manner.
For FY 2014, we are maintaining the policies and methodologies
described in the FY 2012 IRF PPS final rule (76 FR 47836, at 47863
through 47865) relating to the labor market area definitions and the
wage index methodology for areas with wage data. Thus, we are using the
CBSA labor market area definitions and the FY 2013 pre-reclassification
and pre-floor hospital wage index data. In accordance with section
1886(d)(3)(E) of the Act, the FY 2013 pre-reclassification and pre-
floor hospital wage index is based on data submitted for hospital cost
reporting periods beginning on or after October 1, 2008, and before
October 1, 2009 (that is, FY 2009 cost report data).
The labor market designations made by the OMB include some
geographic areas where there are no hospitals and, thus, no hospital
wage index data on
[[Page 47874]]
which to base the calculation of the IRF PPS wage index. We will
continue to use the same methodology discussed in the FY 2008 IRF PPS
final rule (72 FR 44299) to address those geographic areas where there
are no hospitals and, thus, no hospital wage index data in which to
base the calculation for the FY 2014 IRF PPS wage index.
In accordance with our established methodology, we have
historically adopted any CBSA changes that are published in the OMB
bulletin that corresponds with the hospital wage data used to determine
the IRF PPS wage index. The OMB bulletins are available at https://www.whitehouse.gov/omb/bulletins/.
In keeping with the established IRF PPS wage index policy, we will
use the prior year's (FY 2013) pre-floor, pre-reclassified hospital
wage index data to derive the FY 2014 applicable IRF PPS wage index. We
anticipate using the FY 2014 pre-floor, pre-reclassified hospital wage
index data to derive the applicable IRF PPS wage index for FY 2015. We
note, however, that the FY 2014 pre-floor, pre-reclassified hospital
wage index does not use OMB's new 2010 Census-based area delineations,
which were outlined in the February 28, 2013 OMB Bulletin 13-01. This
bulletin contains a number of significant changes. For example, there
are new CBSAs, counties that change from urban to rural, counties that
change from rural to urban, and existing CBSAs that are being split
apart. The OMB Bulletin with these changes was not published in time
for incorporation into the FY 2014 pre-floor, pre-reclassified hospital
wage index, since the proposed rule was already in the advanced stages
of development at that time and the changes and their ramifications
would need to be extensively reviewed and verified prior to their
inclusion in the rule. We therefore intend to consider the
incorporation of these CBSA changes during the development of the FY
2015 hospital wage index. Assuming that we would continue to follow our
established methodology for the IRF PPS wage index, this means that the
2010 Census-based CBSA changes would not be considered for inclusion in
the IRF PPS wage index until FY 2016.
To calculate the wage-adjusted facility payment for the payment
rates set forth in this final rule, we multiply the unadjusted Federal
payment rate for IRFs by the FY 2014 labor-related share based on the
FY 2008-based RPL market basket (69.494 percent) to determine the
labor-related portion of the standard payment amount. We then multiply
the labor-related portion by the applicable IRF wage index from the
tables in the addendum to this final rule. These tables are available
through the Internet on the CMS Web site at https://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/. Table
A is for urban areas, and Table B is for rural areas.
Adjustments or updates to the IRF wage index made under section
1886(j)(6) of the Act must be made in a budget-neutral manner. We
calculate a budget-neutral wage adjustment factor as established in the
FY 2004 IRF PPS final rule (68 FR 45689), codified at Sec.
412.624(e)(1), as described in the steps below. We use the listed steps
to ensure that the FY 2014 IRF standard payment conversion factor
reflects the update to the wage indexes (based on the FY 2009 hospital
cost report data) and the labor-related share in a budget-neutral
manner:
Step 1. Determine the total amount of the estimated FY 2013 IRF PPS
rates, using the FY 2013 standard payment conversion factor and the
labor-related share and the wage indexes from FY 2013 (as published in
the July 30, 2012 FY 2013 IRF PPS notice (77 FR 44618)).
Step 2. Calculate the total amount of estimated IRF PPS payments
using the FY 2013 standard payment conversion factor and the FY 2014
labor-related share and CBSA urban and rural wage indexes.
Step 3. Divide the amount calculated in step 1 by the amount
calculated in step 2. The resulting quotient is the FY 2014 budget-
neutral wage adjustment factor of 1.0010.
Step 4. Apply the FY 2014 budget-neutral wage adjustment factor
from step 3 to the FY 2013 IRF PPS standard payment conversion factor
after the application of the adjusted market basket update to determine
the FY 2014 standard payment conversion factor.
We received 3 comments on the proposed FY 2014 IRF PPS wage index,
which are summarized below.
Comment: Several commenters recommended that we develop a new
methodology for area wage adjustment that eliminates hospital wage
index reclassifications for all hospitals and reduces the problems
associated with annual fluctuations in wage indices and across
geographic boundaries. These commenters also recommended that we
consider wage index policies under the current IPPS because IRFs
compete in a similar labor pool as acute care hospitals. The commenters
suggested that the IPPS wage index policies would allow IRFs to benefit
from the IPPS reclassification and/or floor policies. The commenters
further recommended that until a new wage index system is implemented,
we institute a ``smoothing'' variable to the current process to reduce
the fluctuations IRFs annually experience.
Response: We note that the IRF PPS does not account for geographic
reclassification under sections 1886(d)(8) and (d)(10) of the Act, and
does not apply the ``rural floor'' under section 4410 of Public Law
105-33 (BBA). Furthermore, as we do not have an IRF-specific wage
index, we are unable to determine at this time the degree, if any, to
which a geographic reclassification adjustment or a ``rural floor''
policy under the IRF PPS would be appropriate. The rationale for our
current wage index policies is fully described in the FY 2006 final
rule (70 FR 47880, 47926 through 47928).
Finally, although some commenters recommended that we adopt the
IPPS wage index policies such as reclassification and floor policies,
we note that the Medicare Payment Advisory Commission (MedPAC's) June
2007 report to the Congress, titled ``Report to Congress: Promoting
Greater Efficiency in Medicare,'' recommends that Congress ``repeal the
existing hospital wage index statute, including reclassification and
exceptions, and give the Secretary authority to establish new wage
index systems.'' We continue to believe that adopting the IPPS wage
index policies, such as reclassification or floor, would not be prudent
at this time because MedPAC suggests that the reclassification and
exception policies in the IPPS wage index alter the wage index values
for one-third of IPPS hospitals. As one commenter noted, we have
research currently under way to examine alternatives to the wage index
methodology, including the issues the commenters mentioned about
ensuring that the wage index minimizes fluctuations, matches the costs
of labor in the market, and provides for a single wage index policy.
Section 3137(b) of the Affordable Care Act required us to submit a
report to the Congress by December 31, 2011 that includes a plan to
reform the hospital wage index system. The report that we submitted is
available online at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Reform.html.
We enlisted the help of Acumen, LLC to assist us in meeting the
requirements of section 106(b)(2), Division B, Title I of the Tax
Relief and Health Care Act of 2006 (Pub. L. 109-432, enacted on
December 20, 2006) (TRCA). Acumen, LLC conducted a study of both the
current methodology used to construct the Medicare wage index and the
[[Page 47875]]
recommendations reported to Congress by MedPAC. Parts 1 and 2 of
Acumen's final report, which analyzes the strengths and weaknesses of
the data sources used to construct the CMS and MedPAC indexes, is
available online at https://www.acumenllc.com/reports/cms. The report
took MedPAC's 2009 recommendations on the Medicare wage index
classification system into account, and includes a proposal to revise
the IPPS wage index system. MedPAC's recommendations were noted in the
FY 2009 IPPS final rule (75 FR 48434 at 48563). The proposal considered
each of the following:
The use of Bureau of Labor Statistics data or other data
or methodologies to calculate relative wages for each geographic area.
Minimizing variations in wage index adjustments between
and within MSAs and statewide rural areas.
Methods to minimize the volatility of wage index
adjustments while maintaining the principle of budget neutrality.
The effect that the implementation of the proposal would
have on health care providers in each region of the county.
Issues relating to occupational mix, such as staffing
practices and any evidence on quality of care and patient safety,
including any recommendations for alternative calculations to the
occupational mix.
The provision of a transition period.
We plan to monitor the efforts to develop an alternative wage index
system for the IPPS closely and determine the impact or influence they
may have on the IRF PPS wage index.
Final Decision: After consideration of the public comments
received, we have decided to continue to use the policies and
methodologies described in the FY 2008 IRF PPS final rule relating to
the wage index methodology for areas without wage data. For FY 2014, we
are maintaining the policies and methodologies described in the FY 2012
IRF PPS final rule (76 FR 47836, at 47836 through 47865) relating to
the labor market area definitions and the wage index methodology for
areas with wage data. Therefore, this final rule continues to use the
Core-Based Statistical Area (CBSA) labor market area definitions and
the pre-reclassification and pre-floor hospital wage index data based
on 2009 cost report data. However, we will continue to monitor the IPPS
wage index to identify any policy changes that may be appropriate for
IRFs.
We discuss the calculation of the standard payment conversion
factor for FY 2014 in section VI.E. of this final rule.
E. Description of the IRF Standard Conversion Factor and Payment Rates
for FY 2014
To calculate the standard payment conversion factor for FY 2014, as
illustrated in Table 5, we begin by applying the adjusted market basket
increase factor for FY 2014 that was adjusted in accordance with
sections 1886(j)(3)(C) and (D) of the Act, to the standard payment
conversion factor for FY 2013 ($14,343). Applying the 1.8 percent
adjusted market basket increase factor for FY 2014 to the revised
standard payment conversion factor for FY 2013 of $14,343 yields a
standard payment amount of $14,601. Then, we apply the budget
neutrality factor for the FY 2014 wage index and labor-related share of
1.0010, which results in a standard payment amount of $14,616. We next
apply the budget neutrality factors for the revised CMG relative
weights of 1.0000, which results in a standard payment conversion
factor of $14,616 for FY 2014.
We then apply the budget neutrality factors for the facility
adjustments. Applying the budget neutrality factor for the revised
rural adjustment of 1.0025 results in a standard payment conversion
factor of $14,652. We then apply the budget neutrality factor for the
revised LIP adjustment of 1.0171 resulting in a standard payment
conversion factor of $14,903. Lastly, we apply the budget neutrality
factor for the revised teaching adjustment of 0.9962 which results in a
final standard payment conversion factor for FY 2014 of $14,846.
Table 5--Calculations To Determine the FY 2014 Standard Payment
Conversion Factor
------------------------------------------------------------------------
------------------------------------------------------------------------
Explanation for adjustment Calculations
------------------------------------------------------------------------
Standard Payment Conversion Factor for FY 2013....... $14,343
Market Basket Increase Factor for FY 2014 (2.6 x 1.018
percent), reduced by 0.3 percentage point in
accordance with sections 1886(j)(3)(C) and (D) of
the Act and a 0.5 percentage point reduction for the
productivity adjustment as required by section
1886(j)(3)(C)(ii)(I) of the Act.....................
Budget Neutrality Factor for the Wage Index and Labor- x 1.0010
Related Share.......................................
Budget Neutrality Factor for the Revisions to the CMG x 1.0000
Relative Weights....................................
Budget Neutrality Factor for the Update to the Rural x 1.0025
Adjustment Factor...................................
Budget Neutrality Factor for the Update to the LIP x 1.0171
Adjustment Factor...................................
Budget Neutrality Factor for the Update to the x 0.9962
Teaching Status Adjustment Factor...................
FY 2014 Standard Payment Conversion Factor........... = $14,846
------------------------------------------------------------------------
After the application of the CMG relative weights described in
Section IV of this final rule, to the FY 2014 standard payment
conversion factor ($14,846), the resulting unadjusted IRF prospective
payment rates for FY 2014 are shown in Table 6.
Table 6--FY 2014 Payment Rates
----------------------------------------------------------------------------------------------------------------
Payment rate Payment rate Payment rate Payment rate no
CMG Tier 1 Tier 2 Tier 3 comorbidity
----------------------------------------------------------------------------------------------------------------
0101.................................... $11,851.56 $10,616.37 $9,707.80 $9,262.42
0102.................................... 14,713.87 13,180.28 12,051.98 11,498.23
0103.................................... 17,233.24 15,436.87 14,115.58 13,466.81
0104.................................... 18,129.94 16,240.04 14,848.97 14,167.54
0105.................................... 21,192.67 18,983.58 17,357.94 16,560.71
0106.................................... 24,176.71 21,657.34 19,803.08 18,893.02
0107.................................... 27,294.37 24,448.39 22,356.59 21,329.25
0108.................................... 34,378.88 30,795.06 28,158.41 26,865.32
[[Page 47876]]
0109.................................... 31,161.75 27,913.45 25,523.24 24,351.89
0110.................................... 40,651.32 36,412.78 33,295.12 31,767.47
0201.................................... 12,250.92 10,322.42 9,177.80 8,546.84
0202.................................... 15,661.05 13,196.61 11,734.28 10,926.66
0203.................................... 18,587.19 15,662.53 13,925.55 12,967.98
0204.................................... 19,414.11 16,360.29 14,546.11 13,545.49
0205.................................... 23,443.32 19,755.57 17,564.30 16,355.84
0206.................................... 28,908.13 24,360.80 21,658.83 20,168.29
0207.................................... 38,253.69 32,235.12 28,660.20 26,688.65
0301.................................... 16,306.85 14,033.92 12,573.08 11,627.39
0302.................................... 20,420.67 17,574.69 15,745.67 14,560.96
0303.................................... 24,078.73 20,722.05 18,566.41 17,169.40
0304.................................... 32,352.40 27,843.67 24,945.73 23,069.20
0401.................................... 16,838.33 13,995.32 13,031.82 11,652.63
0402.................................... 20,975.91 17,435.14 16,235.59 14,516.42
0403.................................... 34,375.91 28,572.61 26,605.52 23,789.23
0404.................................... 63,147.46 52,488.03 48,874.52 43,700.69
0405.................................... 51,949.12 43,181.08 40,207.42 35,951.07
0501.................................... 12,446.89 9,779.06 9,216.40 8,392.44
0502.................................... 16,464.21 12,933.84 12,190.05 11,100.35
0503.................................... 21,280.26 16,718.08 15,756.06 14,347.17
0504.................................... 24,592.40 19,320.58 18,208.62 16,580.01
0505.................................... 29,258.50 22,986.06 21,663.28 19,725.88
0506.................................... 40,853.22 32,095.57 30,248.73 27,543.78
0601.................................... 14,318.97 11,624.42 10,729.20 9,725.61
0602.................................... 19,261.20 15,637.29 14,431.80 13,080.81
0603.................................... 24,092.09 19,558.12 18,051.25 16,361.78
0604.................................... 32,190.58 26,133.41 24,118.81 21,862.22
0701.................................... 13,909.22 11,869.38 11,354.22 10,310.55
0702.................................... 18,011.17 15,370.06 14,703.48 13,351.01
0703.................................... 21,884.49 18,674.78 17,864.19 16,222.22
0704.................................... 27,785.77 23,710.55 22,681.72 20,597.34
0801.................................... 10,447.13 9,194.13 8,413.23 7,699.14
0802.................................... 13,739.97 12,092.07 11,066.21 10,126.46
0803.................................... 18,689.63 16,446.40 15,050.87 13,772.63
0804.................................... 16,536.96 14,553.53 13,318.35 12,187.08
0805.................................... 20,419.19 17,969.60 16,444.91 15,047.91
0806.................................... 24,767.58 21,796.90 19,945.60 18,251.67
0901.................................... 13,376.25 11,063.24 10,230.38 9,265.39
0902.................................... 17,935.45 14,834.12 13,719.19 12,424.62
0903.................................... 22,387.77 18,515.93 17,123.38 15,508.13
0904.................................... 29,200.60 24,151.47 22,335.81 20,229.16
1001.................................... 15,255.75 13,873.59 11,910.95 11,011.28
1002.................................... 19,414.11 17,654.86 15,157.77 14,013.14
1003.................................... 28,744.83 26,140.84 22,442.70 20,747.29
1101.................................... 18,110.64 16,563.68 15,294.35 14,929.14
1102.................................... 25,408.93 23,236.96 21,458.41 20,943.25
1201.................................... 14,035.41 13,971.57 12,537.45 11,467.05
1202.................................... 17,442.57 17,362.40 15,580.88 14,250.68
1203.................................... 21,789.47 21,688.52 19,463.11 17,801.84
1301.................................... 17,337.16 14,807.40 13,453.45 12,201.93
1302.................................... 22,306.12 19,050.39 17,308.95 15,699.65
1303.................................... 28,584.49 24,412.76 22,181.41 20,117.81
1401.................................... 13,166.92 10,782.65 9,731.55 8,814.07
1402.................................... 17,708.31 14,501.57 13,088.23 11,854.53
1403.................................... 21,646.95 17,727.61 15,999.53 14,491.18
1404.................................... 27,594.26 22,598.58 20,395.43 18,472.88
1501.................................... 15,036.03 12,819.52 11,584.33 11,095.90
1502.................................... 18,781.67 16,014.38 14,470.40 13,860.23
1503.................................... 22,799.00 19,439.35 17,565.79 16,824.97
1504.................................... 28,292.02 24,121.78 21,798.38 20,877.93
1601.................................... 15,895.61 13,187.70 12,362.26 11,340.86
1602.................................... 20,619.61 17,107.05 16,036.65 14,710.90
1603.................................... 26,078.48 21,635.08 20,282.61 18,606.49
1701.................................... 16,409.28 14,179.41 12,795.77 11,533.86
1702.................................... 20,643.36 17,838.95 16,097.52 14,510.48
1703.................................... 24,574.58 21,235.72 19,163.22 17,273.32
1704.................................... 31,184.02 26,948.46 24,317.75 21,918.63
1801.................................... 16,891.78 15,117.68 13,682.07 11,354.22
1802.................................... 25,992.38 23,262.20 21,054.60 17,472.26
1803.................................... 41,528.72 37,166.96 33,639.55 27,916.42
1901.................................... 16,087.13 13,788.96 13,134.26 12,939.77
[[Page 47877]]
1902.................................... 31,559.63 27,050.90 25,765.23 25,382.21
1903.................................... 52,455.37 44,964.08 42,824.77 42,189.36
2001.................................... 13,178.79 10,788.59 9,933.46 9,066.45
2002.................................... 17,617.75 14,421.40 13,279.75 12,120.27
2003.................................... 22,190.32 18,164.08 16,725.50 15,266.14
2004.................................... 29,113.01 23,829.31 21,942.39 20,027.25
2101.................................... 32,591.42 23,195.39 22,433.79 21,001.15
5001.................................... ................ ................ ................ 2,283.31
5101.................................... ................ ................ ................ 9,823.60
5102.................................... ................ ................ ................ 21,298.07
5103.................................... ................ ................ ................ 11,361.64
5104.................................... ................ ................ ................ 29,224.35
----------------------------------------------------------------------------------------------------------------
F. Example of the Methodology for Adjusting the Federal Prospective
Payment Rates
Table 7 illustrates the methodology for adjusting the federal
prospective payments (as described in sections VI.A. through VI.D. of
this final rule). The following examples are based on two hypothetical
Medicare beneficiaries, both classified into CMG 0110 (without
comorbidities). The unadjusted federal prospective payment rate for CMG
0110 (without comorbidities) appears in Table 6.
Example: One beneficiary is in Facility A, an IRF located in
rural Spencer County, Indiana, and another beneficiary is in
Facility B, an IRF located in urban Harrison County, Indiana.
Facility A, a rural non-teaching hospital has a Disproportionate
Share Hospital (DSH) percentage of 5 percent (which would result in
a LIP adjustment of 1.0156), a wage index of 0.8472, and a rural
adjustment of 14.9 percent. Facility B, an urban teaching hospital,
has a DSH percentage of 15 percent (which would result in a LIP
adjustment of 1.0454 percent), a wage index of 0.8862, and a
teaching status adjustment of 0.0784.
To calculate each IRF's labor and non-labor portion of the Federal
prospective payment, we begin by taking the unadjusted Federal
prospective payment rate for CMG 0110 (without comorbidities) from
Table 6. Then, we multiply the labor-related share for FY 2014 (69.494
percent) described in section VI.C. of this final rule by the
unadjusted federal prospective payment rate. To determine the non-labor
portion of the federal prospective payment rate, we subtract the labor
portion of the federal payment from the unadjusted Federal prospective
payment.
To compute the wage-adjusted federal prospective payment, we
multiply the labor portion of the federal payment by the appropriate
wage index found in tables A and B. These tables are available through
the Internet on the CMS Web site at https://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/. The resulting
figure is the wage-adjusted labor amount. Next, we compute the wage-
adjusted federal payment by adding the wage-adjusted labor amount to
the non-labor portion.
Adjusting the wage-adjusted federal payment by the facility-level
adjustments involves several steps. First, we take the wage-adjusted
Federal prospective payment and multiply it by the appropriate rural
and LIP adjustments (if applicable). Second, to determine the
appropriate amount of additional payment for the teaching status
adjustment (if applicable), we multiply the teaching status adjustment
(0.0784, in this example) by the wage-adjusted and rural-adjusted
amount (if applicable). Finally, we add the additional teaching status
payments (if applicable) to the wage, rural, and LIP-adjusted federal
prospective payment rates. Table 7 illustrates the components of the
adjusted payment calculation.
Table 7--Example of Computing the IRF FY 2014 Federal Prospective
Payment
------------------------------------------------------------------------
---------------------------------------------------------
Steps Rural facility A
(Spencer Co., IN)
Urban facility B
(Harrison Co.,
IN)
------------------------------------------------------------------------
1................ Unadjusted $31,767.47 $31,767.47
Federal
Prospective
Payment.
2................ Labor Share.... x 0.69494 x 0.69494
3................ Labor Portion = $22,076.49 = $22,076.49
of Federal
Payment.
4................ CBSA Based Wage x 0.8472 x 0.8862
Index (shown
in the
Addendum,
Tables 1 and
2).
5................ Wage-Adjusted = $18,703.20 = $19,564.19
Amount.
6................ Non-labor + $9,690.98 + $9,690.98
Amount.
7................ Wage-Adjusted = $28,394.18 = $29,255.17
Federal
Payment.
8................ Rural x 1.1493 x 1.000
Adjustment.
9................ Wage- and Rural- = $32,633.43 = $29,255.17
Adjusted
Federal
Payment.
10............... LIP Adjustment. x 1.0156 x 1.0454
11............... FY 2014 Wage-, = $33,142.51 = $30,583.35
Rural- and LIP-
Adjusted
Federal
Prospective
Payment Rate.
12............... FY 2014 Wage- $32,633.43 $29,255.17
and Rural-
Adjusted
Federal
Prospective
Payment.
13............... Teaching Status x 0 x 0.0784
Adjustment.
14............... Teaching Status = $0.00 = $2,293.61
Adjustment
Amount.
15............... FY 2014 Wage-, + $33,142.51 + $30,583.35
Rural-, and
LIP-Adjusted
Federal
Prospective
Payment Rate.
16............... Total FY 2014 = $33,142.51 = $32,876.96
Adjusted
Federal
Prospective
Payment.
------------------------------------------------------------------------
Thus, the adjusted payment for Facility A would be $33,142.51, and
the adjusted payment for Facility B would be $32,876.96.
We did not receive any comments specifically on the FY 2014 IRF PPS
Federal prospective payment rates.
[[Page 47878]]
VII. Update to Payments for High-Cost Outliers Under the IRF PPS
A. Update to the Outlier Threshold Amount for FY 2014
Section 1886(j)(4) of the Act provides the Secretary with the
authority to make payments in addition to the basic IRF prospective
payments for cases incurring extraordinarily high costs. A case
qualifies for an outlier payment if the estimated cost of the case
exceeds the adjusted outlier threshold. We calculate the adjusted
outlier threshold by adding the IRF PPS payment for the case (that is,
the CMG payment adjusted by all of the relevant facility-level
adjustments) and the adjusted threshold amount (also adjusted by all of
the relevant facility-level adjustments). Then, we calculate the
estimated cost of a case by multiplying the IRF's overall CCR by the
Medicare allowable covered charge. If the estimated cost of the case is
higher than the adjusted outlier threshold, we make an outlier payment
for the case equal to 80 percent of the difference between the
estimated cost of the case and the outlier threshold.
In the FY 2002 IRF PPS final rule (66 FR 41362 through 41363), we
discussed our rationale for setting the outlier threshold amount for
the IRF PPS so that estimated outlier payments would equal 3 percent of
total estimated payments. For the 2002 IRF PPS final rule, we analyzed
various outlier policies using 3, 4, and 5 percent of the total
estimated payments, and we concluded that an outlier policy set at 3
percent of total estimated payments would optimize the extent to which
we could reduce the financial risk to IRFs of caring for high-cost
patients, while still providing for adequate payments for all other
(non-high cost outlier) cases.
Subsequently, we updated the IRF outlier threshold amount in the
FYs 2006 through 2012 IRF PPS final rules and the FY 2011 and FY 2013
notices (70 FR 47880, 71 FR 48354, 72 FR 44284, 73 FR 46370, 74 FR
39762, 75 FR 42836, 76 FR 47836, 76 FR 59256, and 77 FR 44618,
respectively) to maintain estimated outlier payments at 3 percent of
total estimated payments. We also stated in the FY 2009 final rule (73
FR 46370 at 46385) that we would continue to analyze the estimated
outlier payments for subsequent years and adjust the outlier threshold
amount as appropriate to maintain the 3 percent target.
To update the IRF outlier threshold amount for FY 2014, we proposed
to use FY 2012 claims data and the same methodology that we used to set
the initial outlier threshold amount in the FY 2002 IRF PPS final rule
(66 FR 41316 and 41362 through 41363), which is also the same
methodology that we used to update the outlier threshold amounts for
FYs 2006 through 2013. Based on an analysis of this updated data, we
estimate that IRF outlier payments as a percentage of total estimated
payments are approximately 2.5 percent in FY 2014. This estimated
percentage changed more than usual between the proposed rule and the
final rule due to the use of updated data for the final rule (from 2.8
percent in the proposed rule to 2.5 percent in the final rule). Our
analysis indicates that this change was due to a larger-than-usual
change in individual IRFs' CCRs between the proposed rule and the final
rule. This may be the result of outlier reconciliation policies that we
recently implemented for the IRF PPS that result in more current CCRs
being used to calculate the outlier payments. Based on our updated
estimates, then, we update the outlier threshold amount to $9,272 to
maintain estimated outlier payments at approximately 3 percent of total
estimated aggregate IRF payments for FY 2014.
We received 4 comments on the update to the outlier threshold
amount for FY 2014, which are summarized below.
Comment: Several commenters expressed support for the proposed
update to the outlier threshold amount to maintain estimated IRF
outlier payments for FY 2014 at 3 percent of total IRF PPS payments.
However, several other commenters expressed concerns that actual IRF
outlier payments in recent years have tended to fall below 3 percent of
total IRF PPS payments. These commenters requested that we evaluate the
IRF PPS outlier policy to ensure that it is working as intended, adopt
similar changes in the IRF PPS outlier calculation that are proposed
for the FY 2014 IPPS outlier calculation, and incorporate any unused
outlier payments from years in which aggregate outlier payments are
below the 3 percent target back into the IRF PPS base payments for
subsequent years. One commenter also suggested that we lower the
outlier pool from 3 percent to 1.5 or 2 percent, and add the money back
into the IRF PPS base payment amount.
Response: We will continue to monitor our IRF outlier policies to
ensure that they continue to compensate IRFs for treating unusually
high-cost patients and, thereby, promote access to care for patients
who are likely to require unusually high-cost care. At this time, we do
not have any indications to suggest that the outlier pool would be
better set at 1.5 or 2 percent than at 3 percent.
We do not make adjustments to IRF PPS payment rates for the sole
purpose of accounting for differences between projected and actual
outlier payments. We use the best available data at the time to
establish an outlier threshold for IRF PPS payments prior to the
beginning of each fiscal year so that estimated outlier payments for
that fiscal year will equal 3 percent of total estimated total IRF PPS
payments. We evaluate the status of our outlier expenditures annually
and if there is a difference from our projection, that information is
used to make a prospective adjustment to lower or raise the outlier
threshold for the upcoming fiscal year. We do not make retrospective
adjustments. If outlier payments for a given year turn out to be
greater than projected, we do not recoup money from hospitals; if
outlier payments for a given year are lower than projected, we do not
make an adjustment to account for the difference. Payments for a given
discharge in a given fiscal year are generally intended to reflect or
address the average costs of that discharge in that year; that goal
would be undermined if we adjusted IRF PPS payments to account for
``underpayments'' or ``overpayments'' in IRF outliers in previous
years.
We also note that the IPPS outlier payments are not calculated
using the same methodology as the IRF PPS outlier calculations, so
recently implemented and proposed changes to the IPPS methodology for
calculating outlier payments would not be applicable for the IRF PPS
unless we were to change our entire methodology for calculating IRF
outlier payments to mirror the IPPS methodology, which we are not
considering at this time.
Final Decision: Having carefully considered the public comments
received, we are reducing the outlier threshold amount to $9,272 to
maintain estimated outlier payments at 3 percent of total estimated
aggregate IRF payments for FY 2014. This update is effective October 1,
2013. We will continue to monitor trends in IRF outlier payments to
ensure that they are working as intended to compensate IRFs for
treating exceptionally high-cost IRF patients.
B. Update to the IRF Cost-to-Charge Ratio Ceiling and Urban/Rural
Averages
In accordance with the methodology stated in the FY 2004 IRF PPS
final rule (68 FR 45674, 45692 through 45694), we apply a ceiling to
IRFs' CCRs. Using the methodology described in that final rule, we
update the national urban and
[[Page 47879]]
rural CCRs for IRFs, as well as the national CCR ceiling for FY 2014,
based on analysis of the most recent data that is available. We apply
the national urban and rural CCRs in the following situations:
New IRFs that have not yet submitted their first Medicare
cost report.
IRFs whose overall CCR is in excess of the national CCR
ceiling for FY 2014, as discussed below.
Other IRFs for which accurate data to calculate an overall
CCR are not available.
Specifically, for FY 2014, we estimate a national average CCR of
0.643 for rural IRFs, which we calculate by taking an average of the
CCRs for all rural IRFs using their most recently submitted cost report
data. Similarly, we estimate a national average CCR of 0.516 for urban
IRFs, which we calculate by taking an average of the CCRs for all urban
IRFs using their most recently submitted cost report data. We apply
weights to both of these averages using the IRFs' estimated costs,
meaning that the CCRs of IRFs with higher costs factor more heavily
into the averages than the CCRs of IRFs with lower costs. For this
final rule, we have used the most recent available cost report data (FY
2011). This includes all IRFs whose cost reporting periods begin on or
after October 1, 2010, and before October 1, 2011. If, for any IRF, the
FY 2011 cost report was missing or had an ``as submitted'' status, we
used data from a previous fiscal year's (that is, FY 2004 through FY
2010) settled cost report for that IRF. We do not use cost report data
from before FY 2004 for any IRF because changes in IRF utilization
since FY 2004 resulting from the 60 percent rule and IRF medical review
activities suggest that these older data do not adequately reflect the
current cost of care.
In accordance with past practice, we will set the national CCR
ceiling at 3 standard deviations above the mean CCR. Using this method,
the national CCR ceiling is set at 1.57 for FY 2014. This means that,
if an individual IRF's CCR exceeds this ceiling of 1.57 for FY 2014, we
will replace the IRF's CCR with the appropriate national average CCR
(either rural or urban, depending on the geographic location of the
IRF). We estimate the national CCR ceiling by:
Step 1. Taking the national average CCR (weighted by each IRF's
total costs, as discussed above) of all IRFs for which we have
sufficient cost report data (both rural and urban IRFs combined).
Step 2. Estimating the standard deviation of the national average
CCR computed in step 1.
Step 3. Multiplying the standard deviation of the national average
CCR computed in step 2 by a factor of 3 to compute a statistically
significant reliable ceiling.
Step 4. Adding the result from step 3 to the national average CCR
of all IRFs for which we have sufficient cost report data, from step 1.
We did not receive any comments on the proposed updates to the IRF
CCR ceilings and urban/rural averages.
Final Decision: We did not receive any comments on the IRF CCR
ceiling or urban/rural averages. Therefore, we are finalizing the
national average urban CCR at 0.516, the national average rural CCR at
0.643, and the national CCR ceiling at 1.57 percent for FY 2014. These
updates are effective October 1, 2013.
VIII. Refinements to the Presumptive Compliance Methodology
A. Background on the Compliance Percentage
The compliance percentage has been part of the criteria for
defining IRFs since implementation of the IPPS in 1983. In the
September 1, 1983 interim final rule with comment period (48 FR 39752)
which allowed IRFs to be paid separately from the IPPS, the initial
compliance percentage was set at 75 percent. The 1983 interim rule
stipulated that in accordance with sections 1886(d)(1)(B) and
1886(d)(1)(B)(ii) of the Act, a rehabilitation hospital and a
rehabilitation unit were excluded from the IPPS. Sections 1886(d)(1)(B)
and 1886(d)(1)(B)(ii) of the Act also give the Secretary the discretion
to define a rehabilitation hospital and unit.
A hospital or unit deemed excluded from the IPPS and paid under the
IRF PPS must meet the general requirements in subpart B and subpart P
of part 412. Subject to the special payment provisions of Sec.
412.22(c), a hospital or unit must meet the general criteria set forth
in Sec. 412.22 and in the regulations at Sec. 412.23(b), Sec.
412.25, and Sec. 412.29 that specify the criteria for a provider to be
classified as a rehabilitation hospital or unit. Hospitals and units
meeting these criteria are eligible to be paid on a prospective payment
basis as an IRF under the IRF PPS.
The 1983 interim final rule stipulated that one of the criteria for
being classified as an IRF was that, during the facility's most
recently completed 12-month cost reporting period, the hospital must be
primarily engaged in furnishing intensive rehabilitation services, as
demonstrated by patient medical records, indicating that at least 75
percent of the IRF's patient population were treated for one or more of
the 10 medical conditions specified in the regulation that typically
required the intensive inpatient rehabilitation treatment provided in
an IRF. These criteria, along with other related criteria,
distinguished an inpatient rehabilitation hospital or unit from a
hospital that furnished general medical or surgical services, as well
as rehabilitation services. We believed then, as we do now, that by
examining the types of conditions for which a hospital's inpatients are
treated, and the proportion of patients treated for conditions that
typically require intensive inpatient rehabilitation, we would be able
to distinguish those hospitals in which the provision of rehabilitation
services was primary rather than secondary. Thus, Medicare pays for
rehabilitation services at IRFs at a higher rate than other hospitals
because IRFs are designed to offer specialized inpatient rehabilitation
care to patients with intensive needs.
The original medical conditions specified under the compliance
percentage, or ``75 percent rule,'' were stroke, spinal cord injury,
congenital deformity, amputation, major multiple trauma, fracture of
femur (hip fracture), brain injury, and polyarthritis (including
rheumatoid arthritis). In the January 3, 1984 final rule (49 FR 234),
we expanded the list of eligible medical conditions to include
neurological disorders (including multiple sclerosis, motor neuron
diseases, polyneuropathy, muscular dystrophy, and Parkinson's disease)
and burns. In the May 7, 2004 final rule (69 FR 25752), we modified and
expanded the list of eligible medical conditions by removing
polyarthritis and substituting three more clearly defined arthritis-
related conditions. The three conditions that replaced polyarthritis
included the following:
Active, polyarticular rheumatoid arthritis, psoriatic
arthritis, and seronegative arthropathies resulting in significant
functional impairment of ambulation and other activities of daily
living, which has not improved after an appropriate, aggressive, and
sustained course of outpatient therapy services or services in other
less intensive rehabilitation settings immediately preceding the
inpatient rehabilitation admission or which results from a systemic
disease activation immediately before admission, but has the potential
to improve with more intensive rehabilitation.
Systemic vasculidities with joint inflammation, resulting
in significant functional impairment of ambulation
[[Page 47880]]
and other activities of daily living, which has not improved after an
appropriate, aggressive, and sustained course of outpatient therapy
services or services in other less intensive rehabilitation settings
immediately preceding the inpatient rehabilitation admission or which
results from a systemic disease activation immediately before
admission, but has the potential to improve with more intensive
rehabilitation.
Severe or advanced osteoarthritis (osteoarthrosis or
degenerative joint disease) involving three or more major joints
(elbow, shoulders, hips, or knees) with joint deformity and substantial
loss of range of motion, atrophy, significant functional impairment of
ambulation and other activities of daily living, which has not improved
after an appropriate, aggressive, and sustained course of outpatient
therapy services or services in other less intensive rehabilitation
settings immediately preceding the inpatient rehabilitation admission
but has the potential to improve with more intensive rehabilitation. (A
joint replaced by a prosthesis is no longer considered to have
osteoarthritis, or other arthritis, even though this condition was the
reason for the joint replacement.)
In the May 7, 2004 final rule (69 FR 25752), a 13th condition was
also added to include patients who undergo knee and/or hip joint
replacement during an acute hospitalization immediately preceding the
inpatient rehabilitation stay and also meet at least one of the
following specific criteria:
Underwent bilateral knee or hip joint replacement surgery
during the acute hospitalization immediately preceding the IRF
admission.
Are extremely obese patients as measured by the patient's
Body Mass Index (BMI) of at least 50, at the time of admission to the
IRF.
Are patients considered to be ``frail elderly,'' as
determined by a patient's age of 85 or older, at the time of admission
to the IRF (the provision currently states only that the patients be
age 85 or older at the time of admission to the IRF)
In 2002, we surveyed Medicare fiscal intermediaries to determine
how they were enforcing the 75 percent rule. Although the 75 percent
rule was one of the criteria that were used to distinguish an IRF from
an acute care hospital from 1983 to 2004, we found evidence that
different fiscal intermediaries were enforcing the rule differently. We
found fiscal intermediaries were using inconsistent methods to
determine whether IRFs were in compliance with the regulation, and that
some IRFs were not being reviewed for compliance at all. This led to
concerns that some IRFs might have been out of compliance with the
regulation and inappropriately classified as IRFs, while other IRFs may
have been held to overly high standards. Because of these concerns we
sought to establish a more uniform enforcement of the 75 percent rule.
In the May 16, 2003 IRF PPS proposed rule (68 FR 26786), we
solicited comments on the regulatory requirements of the 75 percent
rule. Though we did not, at that time, propose amending the regulatory
requirements for the 75 percent rule located in then Sec.
412.23(b)(2), we did propose to amend these requirements in the
September 9, 2003 proposed rule titled, ``Medicare Program; Changes to
the Criteria for Being Classified as an Inpatient Rehabilitation
Facility'' (68 FR 53266). In that rule, we proposed some revisions to
the 75 percent rule, including lowering the compliance percentage to 65
percent during a 3-year transition period for cost reporting periods
between January 1, 2004 and January 1, 2007. Also, in response to
comments on the September 9, 2003 proposed rule and as stated above,
the May 7, 2004 final rule (69 FR 25752) expanded the number of medical
conditions that would meet the compliance percentage from 10 to 13 and
provided that patient comorbidities may also be included in determining
an IRF's compliance with the requirements during the transition period.
In the September 9, 2003 proposed rule, we defined a
``comorbidity'' as a specific patient condition that is secondary to
the patient's principal diagnosis or impairment that is the primary
reason for the inpatient rehabilitation stay. In the May 7, 2004 rule,
we adopted the provision to use a patient with a comorbidity counting
towards the compliance threshold during the transition period. In the
determination of the compliance percentage, a patient comorbidity
counts toward the percentage if the comorbidity falls in one of the
conditions specified at Sec. 412.29(b)(2) and has caused significant
decline in functional ability in the individual that even in the
absence of the admitting condition, the individual would require the
intensive rehabilitation treatment that is unique to IRFs.
Anticipating that IRFs needed some time to adjust and adapt their
processes to the changes in the enforcement of the 75 percent rule, in
the May 7, 2004 final rule, we provided IRFs with a 3-year phase-in
period (cost reporting periods beginning on or after July 1, 2004
through July 1, 2007) to establish the compliance threshold of 75
percent of the IRF's total patient population. The 3-year phase-in
period was intended to begin with cost reporting periods on or after
July 1, 2004 with the threshold at 50 percent of the IRF's population
and gradually increase to 60 percent, then to 65 percent, and then to
expire with cost reporting periods beginning on or after July 1, 2007,
when the compliance percentage would once again be at 75 percent.
Section 5005 of the Deficit Reduction Act of 2005 (DRA, Pub. L.
109-171, enacted February 8, 2006) and section 1886(d)(1)(B) of the Act
modified the provisions of the 75 percent rule originally specified in
the May 7, 2004 final rule. To reflect these statutory changes, in the
August 7, 2007 final rule (72 FR 44284), we revised the regulations to
prolong the overall duration of the phased transition to the full 75
percent threshold by stipulating that an IRF must meet the full 75
percent compliance threshold as of its first cost reporting period that
starts on or after July 1, 2008. We also extended the policy of using a
patient's comorbidities to the extent they met the conditions as
outlined in the regulations to determine compliance with the
classification criteria at then Sec. 412.23(b)(2)(1) to the first cost
reporting period that starts on or after July 1, 2008.
Subsequently, section 115 of the MMSEA amended section 5005 of the
DRA to revise elements of the 75 percent rule that are used to classify
IRFs. In accordance with the statute, in the August 8, 2008 final rule
(73 FR 46370), we revised the compliance rate that IRFs must meet to be
excluded from the IPPS and be paid under the IRF PPS to 60 percent for
cost reporting periods beginning in or after July 1, 2006. Also, in
accordance with the statute, we required that patient comorbidities
that satisfy the criteria as specified at then Sec. 412.23(b)(2)(i)
[now located at Sec. 412.29(b)(1) and Sec. 412.29(b)(2)] be included
in calculations used to determine whether an IRF meets the 60 percent
compliance percentage for cost reporting periods beginning on or after
July 1, 2007. As a result of these changes, the requirements started
being referred to as the ``60 percent rule,'' instead of the ``75
percent rule.'' The regulations finalized in the FY 2009 IRF PPS Final
Rule (73 FR 46370) continue to be in effect.
Though an IRF must serve an inpatient population of whom at least
60 percent meet the compliance percentage criteria specified at Sec.
412.29(b), the existing regulation allows for 40 percent of reasonable
and
[[Page 47881]]
necessary admissions to an IRF to fall outside of the 13 qualifying
medical conditions. Still, the ``60 percent rule'' is one of the
primary ways we distinguish an IRF from an acute care hospital. As
Medicare payments for IRF services are generally significantly higher
than Medicare payments for similar services provided in acute care
hospital settings, we believe that it is important to maintain and
enforce the criteria for medical conditions that may be counted toward
an IRF's compliance calculation for the 60 percent rule to ensure that
the higher Medicare payments are appropriately allocated to those
providers that are providing IRF-level services.
B. Changes to the ICD-9-CM Codes That Are Used To Determine Presumptive
Compliance
The presumptive compliance method is one of two ways that
Medicare's contractors may evaluate an IRF's compliance with the 60
percent rule (the other method is called the medical review method).
IRFs may only be evaluated using the presumptive compliance method if
their Medicare Fee-for-Service and Medicare Advantage patient
populations make up over half of their total patient population, so
that the Medicare populations can be presumed to be representative of
the IRF's total patient population. If an IRF is eligible to have its
compliance under the 60 percent rule measured using the presumptive
compliance method, under the rule, it is given the option of whether
the Medicare contractor will review all of the IRF's discharges from
that period, or all admissions from that period. All of its IRF-PAI
assessments in the chosen category from the most recently completed 12
month compliance review period are then examined (with the use of a
computer program) to determine whether they contain any of the ICD-9-CM
diagnosis codes that are listed in the ``ICD-9-CM Codes That Meet
Presumptive Compliance Criteria'' (which is also known as the
presumptive methodology list). Each selected assessment is categorized
as either meeting or not meeting the criteria for the medical
conditions that may be counted towards the IRF's 60 percent rule
compliance calculation based on coded information about the primary
reason the patient was admitted to the IRF (the impairment group) and
the ICD-9-CM codes listed as either the etiologic diagnosis (the
etiologic problem that led to the condition for which the patient is
receiving rehabilitation) or one of the comorbidities listed on the
assessment. An impairment group code is not an ICD-9-CM code, but part
of a separate unique set of codes specifically developed for the IRF
PPS for assigning the primary reason for admission to an IRF. Those
ICD-9-CM diagnosis codes that appear on the patient's IRF-PAI
assessment as either the etiologic diagnosis or comorbid conditions
that are also listed in ``ICD-9-CM Codes That Meet Presumptive
Compliance Criteria'' are deemed to demonstrate that the patient meets
the criteria for the medical conditions that may be counted toward the
IRF's compliance percentage under the presumptive compliance method of
calculating the compliance percentage. The current presumptive
compliance list can be downloaded from the October 1, 2007 IRF
Compliance Rule Specification Files on the Medicare IRF PPS Web site at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Criteria.html. The ICD-9-CM Codes That Meet
Presumptive Compliance Criteria that takes what we are finalizing in
this rule into account can be downloaded from the Medicare IRF PPS Web
site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html. We will build our ICD-10-CM
version of the presumptive methodology list off of this document.
The underlying premise of the presumptive methodology list is that
it represents particular diagnosis codes that, if applicable to a given
patient, would more than likely mean that the patient required
intensive rehabilitation services for treatment of one or more of the
conditions specified at Sec. 412.29(b)(2) or that they had a
comorbidity that caused significant decline in functional ability such
that, even in the absence of the admitting condition, the patient would
require the intensive rehabilitation treatment that is unique to
inpatient rehabilitation facilities and cannot be appropriately
performed in another care setting.
Recently, we began a close examination of the list of ICD-9-CM
codes that are currently deemed to meet the criteria for the medical
conditions that may be counted toward an IRF's compliance with the 60
percent rule under the presumptive compliance method to begin the
process of converting this code list to ICD-10-CM. Upon this
examination, we found that changes over time (including changes in the
use of the individual codes, changes in clinical practice, changes in
the frequency of various types of illness and disability, and changes
to the application of 60 percent rule itself) supported our updating
the ICD-9-CM codes that are deemed appropriate to count toward a
facility's 60 percent rule compliance calculation. Such updates would
ensure that the codes better reflect the regulations at Sec.
412.29(b).
Our review included taking a fresh look at the regulations in Sec.
412.29(b), which revealed that the following parts of the regulation
were not being adequately addressed in the current application of the
presumptive method of calculating compliance with the IRF 60 percent
rule:
The details of the requirements in paragraph Sec.
412.29(b)(1), which specify that the IRF must serve ``an inpatient
population of whom at least 60 percent required intensive
rehabilitation services for treatment of one or more of the conditions
specified . . .'', and
The details of the requirements regarding the specific
conditions under which a patient's comorbidity may be used to show that
a patient meets the 60 percent rule criteria, specifically that, ``The
comorbidity has caused significant decline in functional ability in the
individual that, even in the absence of the admitting condition, the
individual would require the intensive rehabilitation treatment that is
unique to inpatient rehabilitation facilities . . .and that cannot be
appropriately performed in another care setting . . .''
These requirements must be met in conjunction with a patient having
one of the 13 conditions listed in Sec. 412.29(b)(2) for the case to
meet the 60 percent rule compliance criteria. It is not enough for the
patient to just have one of the 13 conditions. Mindful of these
requirements, we took a fresh look at the ICD-9-CM codes on the
presumptive methodology list.
Further, the regulations in Sec. 412.29 also specify that the
arthritis conditions only meet the 60 percent rule compliance criteria
if certain severity and prior treatment criteria are met. It is
impossible to discern from the ICD-9-CM codes alone whether or not the
required severity and prior treatment criteria are met for those
patients being treated for arthritis conditions. This type of
information can only be assessed on medical review. Thus, we found that
the presence of the ICD-9-CM code, by itself, cannot always allow us to
presume that patients meet all of the requirements for being counted
toward a facility's meeting the 60 percent rule requirements. As such,
we believe that certain ICD-9-CM codes currently on the presumptive
methodology list do not necessarily demonstrate a patient's meeting the
medical condition (including severity and prior treatment) requirements
for inclusion in a facility's
[[Page 47882]]
60 percent compliance calculation under the presumptive compliance
method, and, as such, should be removed from the presumptive
methodology list to better reflect the regulations.
Therefore, we performed a clinical analysis of the ICD-9-CM code
list to determine the clinical appropriateness of each individual ICD-
9-CM code's inclusion on the list, and a statistical analysis of the
ICD-9-CM diagnoses code list to enhance our understanding of how
individual ICD-9-CM codes are being used by IRFs. Based on these
analyses, we proposed specific revisions to the ICD-9-CM code list that
are described below in sections VIII.B.1 through VIII.B.6 of this final
rule.
We received 39 public comments on the proposed changes to the
presumptive methodology list, which are summarized below.
Comment: Several commenters stated that section 5005 of the DRA of
2005, and section 115 of the MMSEA of 2007 ``codified'' the 13
qualifying medical conditions that were originally adopted in our May
7, 2004 final rule and that were still in the regulations in effect as
of January 1, 2007, and froze the compliance threshold at 60 percent.
These commenters also expressed the belief that CMS does not have the
legal authority to make changes to the presumptive methodology list as
proposed and must appeal to Congress to make such changes. One
commenter stated that Congress ``was clear in the statute'' that for
purposes of determining a facility's compliance under the presumptive
compliance method, that CMS should utilize the May 7, 2004 final rule
and the 13 qualifying medical conditions described in that final rule.
Response: While the commenters are correct that the DRA of 2005 and
the MMSEA of 2007 both referenced the regulatory text that was adopted
in the May 7, 2004 final rule, or the rule itself, we disagree with the
assertion that the proposed changes to the ``ICD-9-CM Codes That Meet
Presumptive Compliance Criteria'' list are in contravention of section
5005 of the DRA as amended by section 115 of MMSEA. Additionally, as we
did not propose any changes to the compliance threshold (it remains at
60 percent), the comments regarding the 60 percent threshold are
outside the scope of this rule.
Subsection (a) of section 5005 of the DRA stipulated that the
Secretary should apply the applicable percent ``in the classification
criterion used under the IRF regulation (as defined in subsection (c))
to determine whether a hospital or unit of a hospital is an inpatient
rehabilitation facility under the Medicare program under title XVIII of
the Social Security Act.'' Subsection (c) of section 5005 of the DRA
then stated that ``[f]or purposes of subsection (a), the term ``IRF
regulation'' means the rule published in the Federal Register on May 7,
2004. . . .''
Even if we were to agree with commenters' assertions that this
cross-reference froze the medical conditions that could be considered
for the 75-percent compliance rule to the 13 medical conditions listed
in the May 7, 2004 final rule, however, it would not follow that
Congress froze the sub-regulatory means of verifying compliance with
the severity and prior treatment requirements that were contained in
that final rule. We disagree with any assertion that the proposed
removal of certain ICD-9-CM codes from the sub-regulatory listing of
codes that presumptively count toward the IRF compliance calculation
under the presumptive compliance method would, in fact or effect,
remove any of the 13 qualifying medical conditions under the
classification criteria established in our May 7, 2004 final rule (69
FR 25752). Rather, it merely means that the medical review method would
need to be used.
For example, the ``arthritis'' categories in the May 7, 2004 final
rule only included those arthritis patients that meet the severity and
pretreatment conditions specified in the regulations prior to the
patient's admission to the IRF. See, the former 42 CFR Sec.
412.23(b)(2)(iii)(L), which can be found at 69 FR 25772. As such, the
severity and pretreatment requirements were part of the defined
condition, and any sub-regulatory procedures to implement these
regulatory conditions would have to take into account the need to
ensure compliance with these severity and pretreatment requirements.
Furthermore, while the May 7, 2004 final rule noted that CMS would
be issuing sub-regulatory guidance to its contractors that were to be
tasked with the administration of the verification process for these
requirements, the substance of such processes is not in the final rule.
What are in the rule, however, are multiple statements that ICD-9-CM
diagnosis codes alone would not, in the absence of additional clinical
data, demonstrate compliance with the severity and pre-treatment
requirements. Some other mechanism, such as medical review, was
contemplated from the outset for these conditions (69 FR 25752, 25755
and 25761).
Thus, we have not proposed changes to the criteria established in
the May 7, 2004 final rule. It remains as a list of 13 medical
conditions, at times, paired with additional severity and prior
treatment requirements. And, with the exception of discussion about
imputing the Medicare portion of a facility's patient population
compliance percentage to the entire population when the Medicare
population represents the majority of that facility's patients, it did
not discuss, let alone ``codify'' the methods we would use to verify
IRFs' compliance percentages. Rather, we merely stated in that rule
that we would issue instructions to the FIs that serve as the Medicare
contractors and provide guidance to the clinical/medical FI personnel
responsible for performing the compliance reviews to ensure that they
use a method that consistently counts only cases with a diagnosis that
both serves as the basis for intensive rehabilitation services and
meets one of the 13 qualifying medical conditions; noted that we were
still determining how best to provide guidance to the FIs on how to
identify patients that fall into the 13 medical conditions; noted that
we would not be providing ICD-9-CM codes in response to a commenter
because diagnosis would be only one aspect of the FI's determination;
and stated that FIs would also ``review information to assess (1) the
medical necessity of rehabilitation in an inpatient setting; (2) the
severity of the specific condition(s); (3) the patient's function; and
(4) the capacity of the patient to participate in intensive
rehabilitation and benefit from it.''
As such, we believe that the proposed removal of some of the ICD-9-
CM codes in our sub-regulatory presumptive methodology list is
consistent with the legislation and the May 7, 2004 regulation. We have
not proposed the revision of the list of 13 medical conditions or the
severity and prior treatment requirements that were paired with those
conditions. For example, consistent with the severity and pretreatment
requirements defined in the regulations (which are currently located at
Sec. 412.29(b)(2)(x) through Sec. 412.29(b)(2)(xiii), we proposed the
removal of the ``arthritis'' ICD-9-CM codes because those codes do not
provide the pertinent information necessary to assess whether the
applicable severity and prior treatment requirements for those
conditions have been met. If and when the severity and pretreatment
requirements are confirmed using the medical review method, however,
patients with those arthritis conditions will be counted toward the
IRF's compliance threshold.
[[Page 47883]]
In this manner, we administratively apply the regulation as codified
and as outlined in the May 7, 2004 final rule. Ultimately, the code
refinements to the ICD-9-CM Codes That Meet Presumptive Compliance
Criteria list will ensure that the codes represent the types of medical
conditions that we believe clearly, and without further evidence, can
be found to indicate that the criteria for the medical conditions that
may be counted toward the 60 percent rule compliance calculation have
been met, and, therefore, that the presumptive compliance method can be
used to include that individual in the IRF's compliance percentage.
Comment: Several commenters suggested that we delay these
refinements to the presumptive compliance list until next year when the
implementation of ICD-10-CM is planned. Commenters also stated that
making these changes effective for discharges on or after October 1,
2013 will cause significant disruption for providers. One commenter
asked for clarification regarding how the proposed changes would be
implemented, specifically whether the prior list would be applied for
the first part of a facility's fiscal year and the new list be applied
for the second part. Several commenters asked that we provide a 6-month
transition period to implement these changes.
Response: We considered the impact that our proposals would have on
IRF providers if we were to make the changes effective for FY 2014
instead of in FY 2015 when we plan to move to ICD-10-CM. We believed
that a gradual approach allowing IRF providers time to adjust their
coding practices in response to the specific changes made to the
presumptive methodology list before also moving to ICD-10-CM was the
appropriate course of action. However, we recognize that IRFs may need
more time to adjust to the changes to the presumptive methodology list.
In recognition of these concerns, we will adopt these changes, but only
apply the revised list to compliance review periods beginning on or
after October 1, 2014. This will eliminate any problems associated with
changing lists in the middle of a fiscal year.
Comment: One commenter supported our efforts to refine the list of
ICD-9-CM codes in the presumptive methodology list. But, the commenter
also stated that a better overall system would be one in which payment
systems would be focused on patient-based criteria at the level of the
episode of care or other broader site-neutral systems; however, within
the current payment system, they supported CMS' efforts to improve
accuracy in determining the need for the intensive inpatient
rehabilitation services that IRFs provide. Further, the commenter
stated that by ``requiring IRFs to use more detailed coding, we could
potentially collect information on IRF patients that would
differentiate them from patients with similar conditions who are
treated in other settings (for example, skilled nursing facilities,
home health agencies, or outpatient therapy providers).''
Response: We thank the commenter for their support of our efforts
to refine the presumptive methodology list so that it reflects codes
that truly indicate compliance with the 60 percent rule criteria for
inclusion in the compliance calculation. Additionally, we thank the
commenter for their suggestions as the agency continues research
efforts into broader site-neutral payment systems.
Comment: Several commenters stated that they had concerns about the
viability of the ``60 percent rule.'' One commenter stated that the 60
percent rule should be repealed or modified in that the current
classification criteria do not reflect the full range of factors that
contribute to a patient's need for intensive inpatient rehabilitation.
The commenter also stated that if we continue to use the 60 percent
rule, then the list of 13 qualifying medical conditions under the 60
percent rule should be expanded to include patients with the following
conditions: orthopedic/joint/limb replacement patients, post-transplant
patients, patients with chronic pulmonary and cardiac conditions, and
medically complex patients.
Response: We appreciate the commenters' suggestions, and will take
these suggestions into account in future analyses. However, since we
did not propose any modifications to the qualifying medical conditions
for the 60 percent rule, these comments are beyond the scope of this
final rule.
Comment: One commenter stated that we should clarify the alphabet
designations for appendices associated with IRF-PAI completion because
in our rules (this year and in past rulemakings) we have used the same
alphabet character for more than one list.
Response: We agree that the alphabet designations used for
appendices in the IRF PPS may lead to confusion because appendices for
several tables are listed with the same alphabet character. Appendix C:
ICD-9-CM Codes That Meet Presumptive Compliance Criteria is used to
determine an IRF's presumptive compliance with the 60 percent rule.
However, there is also the list of comorbidities (ICD-9-CM codes) that
is used to determine placement in tiers, Appendix C--List of
Comorbidities. Beginning with the publication of this rule, we will no
longer use alphabet characters to identify these appendices. Beginning
with this final rule and related sub-regulatory guidance, we will refer
to the two lists by their titles, without the Appendix labels.
Comment: One commenter recommended that in lieu of removing the
ICD-9-CM codes from the ICD-9-CM Codes That Meet Presumptive Compliance
Criteria, CMS should establish modifiers that could be entered on the
IRF-PAI to indicate that the patient meets the requirements for the
medical conditions that may be included in the IRF's presumptive
compliance method's compliance calculation. The commenter offered the
following example that is used on claims: the KX modifier with respect
to outpatient therapy services to indicate that a patient qualifies for
an exception to the therapy caps on the claim. The commenter stated
that using modifiers would ensure that ``clinically appropriate''
records would count under the presumptive compliance method compliance
calculations without having to do medical review.
Response: We appreciate the commenter's suggestion. However, we
note that the presumptive compliance method relies on information
recorded on the IRF-PAI, rather than information from the IRF claim.
The purpose of the IRF-PAI is to collect the clinical characteristics
of the patient for use in care planning, payment, and quality reporting
and therefore we believe it presents a more accurate and comprehensive
record of the medical conditions of the patient, which is important
when the record is then used to calculate the presumptive compliance
percentage. Thus, we do not currently use and are not planning in the
future to use, the IRF claim for the presumptive compliance method.
Thus, a modifier applied to the coding on the claim, similar to the KX
modifier for outpatient therapy services, is not useful in this
context, and we do not currently have a similar mechanism for modifying
codes on the IRF-PAI. However, we will take the commenter's suggestions
into consideration. We believe that a delayed implementation of the
changes to the presumptive compliance list of ICD-9-CM codes will allow
us additional time to study ways to minimize the burden of the
operational aspects of the changes to the presumptive compliance
methodology.
[[Page 47884]]
Comment: Several commenters stated that we have incorrectly applied
a medical necessity measurement (the coverage criteria) to the 60
percent rule. One commenter stated that we conflated individualized
medical necessity review with the presumptive compliance method's
review. Another commenter requested that we distinguish between the
policies for IRF classification criteria and medical necessity coverage
criteria in the final rule.
Response: We disagree with the commenters; we are not conflating
the criteria for the medical conditions that may be counted under the
presumptive method to determine compliance with the 60 percent rule
with the coverage criteria. IRF coverage criteria are not used to
determine IRF classification. As we stated in the August 7, 2009 final
rule (74 FR 39762), we do not intend for any IRF to lose its
classification status because an individual patient does not meet the
coverage criteria. Failure to meet the coverage criteria in a
particular case will only result in the denial of the IRF's claim for
the services provided to that patient, not in a change in the
classification of the facility.
Comment: Several commenters expressed concerns that, in the
proposed rule, we changed our policy articulated in previous rules of
distinguishing IRFs from other care settings by identifying certain
conditions that ``typically require'' intensive inpatient
rehabilitation. Specifically, commenters asserted that we have deviated
from the policy standard of serving those with conditions that
``typically required'' an IRF-level of service. The commenters point to
our statement in the proposed rule that ``[i]t is not enough for the
patient to just have one of the 13 conditions'' to indicate that we
proposed adding additional criteria to the medical conditions that may
be counted under the presumptive compliance method. For example, the
commenters believed that we had proposed adding a new criterion by
indicating that beyond having one of the 13 medical conditions, we now
proposed to require that patients need intensive inpatient
rehabilitation services. According to the commenters, this is
inconsistent with the history of the 60 percent rule and our own
interpretations of the policy in previous rulemaking.
Response: We disagree with the commenters' assertions that we have
introduced new criteria to the presumptive compliance method of
determining whether an IRF has met the criteria for a given medical
condition such that the individual with that condition may be counted
toward the IRF's 60 percent rule compliance percentage. Section 412.29
outlines the requirements for a facility to be classified for payment
under the IRF PPS. Within this section, the regulations at Sec.
412.29(b)(1) require the IRF to demonstrate that it ``served an
inpatient population of whom at least 60 percent required intensive
rehabilitation services for treatment of one or more of the conditions
specified at paragraph (b)(2) . . . (emphasis added). As such, the
``intensive rehabilitation service needs'' criterion is part of the
original criteria for the medical conditions that can be counted toward
an IRF's 60 percent rule compliance rate. We also point out that this
particular part of the regulation read the same in the May 7, 2004
final rule (then codified in Sec. 412.23(b)(2)(i), now codified in
Sec. 412.29(b)(1)). Thus, our statement in the proposed rule was
consistent with what has been our stated policy since the May 7, 2004
final rule.
We also disagree with any assertion that the proposed changes to
the presumptive methodology list are an indication that we have
departed from historical discussions outlined in the preamble of
previous rules. As we stated previously, we are not revising the
criteria that govern the 13 medical conditions that may be counted
toward an IRF's 60 percent rule compliance percentage. In the preamble
of the May 7, 2004 final rule, when discussing how CMS contractors
would administratively identify patients with the 13 medical
conditions, we specifically declined to provide a list of ICD-9-CM
codes because ICD-9-CM codes alone are not always enough to ascertain
whether someone falls into one of the 13 medical condition categories.
As such, the regulations have never included such a list. Rather, we
use a bifurcated sub-regulatory approach with a presumptive compliance
method and a medical review compliance method. We continue to believe
that the 13 medical conditions that are listed in regulation at Sec.
412.29(b)(2) are conditions that ``typically'' require the level of
intensive rehabilitation that provide the basis of need to
differentiate the services offered in IRFs from those offered in other
care settings.
Comment: One commenter requested that we make available the
methodology that was used to assess the ``clinical appropriateness''
determinations for the ICD-9-CM codes that were proposed for removal.
Response: To analyze the ``clinical appropriateness'' of the ICD-9-
CM codes on the list used to determine compliance under the presumptive
compliance method, we used the extensive clinical and coding expertise
available within CMS's staff. Our clinical staff went through the
current list code-by-code to determine whether, in their professional
judgment, a particular ICD-9-CM code's use would indicate a patient's
presumptive need for intensive inpatient rehabilitation for one of the
13 medical conditions listed in 412.29(b)(2), absent additional
information about a particular patient's clinical condition and
rehabilitation needs. The details of our clinical rationale for each of
the proposed changes to the ICD-9-CM codes used to determine compliance
percentages under the presumptive compliance method were presented in
the FY 2014 IRF PPS proposed rule (78 FR 26880 at 26895 through 26906)
and are further reflected in this final rule. We also used the public
comments we received on the FY 2014 IRF PPS proposed rule (78 FR 26880)
to further refine our clinical analysis, in that we used a lot of the
input from commenters in forming our final decisions regarding which
ICD-9-CM codes to retain on the list and which to proceed to remove
from the list. As discussed in detail below, in some cases we agreed
with the commenter's input and have added codes back to the list, as
appropriate.
Comment: Several commenters requested that we make an IRF's
presumptive testing data available to that IRF to allow the IRF to
monitor its presumptive compliance with the 60 percent rule.
Response: Until now, we did not have the capability within our data
system for securely communicating information about an IRF's individual
IRF-PAI submissions back to that IRF. We are in the process of
developing such a system, and will consider the feasibility of
incorporating a report of an IRF's compliance percentage into this new
system.
1. Non-Specific Diagnosis Codes
We believe that highly descriptive coding provides the best and
clearest way to document the appropriateness of a given patient's
admission, and would improve our ability to use the presumptive
compliance method of calculating a facility's 60 percent rule
compliance percentage. Therefore, whenever possible, we believe that
the most specific code that describes a medical disease, condition, or
injury should be used to document diagnoses on the IRF-PAI. Generally,
``unspecified'' codes are used when there is a lack of information
about location or severity of medical conditions in the medical record.
[[Page 47885]]
However, site and/or severity of condition is often an important
determinant in assessing whether a patient's principal or secondary
diagnosis falls into the 13 qualifying medical conditions that may be
counted toward the facility's 60 percent rule compliance percentage
under the presumptive compliance method. For this reason, we believe
that specific diagnosis codes that narrowly identify anatomical sites
where disease, injury, or condition exist should be used when coding
patients' conditions on the IRF-PAI whenever such codes are available.
Furthermore, on the same note, we believe that one should also include
on the IRF-PAI the more descriptive ICD-9-CM code that indicates the
degree of injury in instances of burns. In accordance with these
principles, we proposed to remove non-specific codes from the list,
ICD-9-CM Codes That Meet Presumptive Compliance Criteria, in instances
in which more specific codes are available as we believe imprecise
codes would inappropriately categorize an overly broad segment of the
patient population as having the conditions required for inclusion in a
facility's presumptive compliance calculation, which would result in an
inflated compliance percentage. If the IRF does not have enough
information about the patient's condition to code the more specific
codes on the IRF-PAI, we would expect the IRF to seek out additional
information from the patient's acute care hospital medical record to
determine the appropriate, more specific code to use. The list of ICD-
9-CM codes that we proposed removing can be found in the May 8, 2013
proposed rule at 78 FR 26880, 26901 through 26906.
We received 18 comments on the proposed changes to the non-specific
diagnosis codes listed in ICD-9-CM Codes That Meet Presumptive
Compliance Criteria, which are summarized below.
Comment: Several commenters noted that IRFs are post-acute settings
and that etiological documentation is based on the data received from
the acute care hospital. They argued that, in some cases, the
specificity demanded in coding as described in the proposed rule cannot
be achieved because the information is not in the records that IRFs
receive from the acute care setting. For example, for ICD-9-CM codes
433.91--Occlusion and stenosis of unspecified pre-cerebral artery with
cerebral infarction--and 434.91--Cerebral artery occlusion, unspecified
with cerebral infarction--, several commenters stated that a large
proportion of ischemic strokes may not be able to be identified as
thrombotic or embolic. Several commenters stated that the ICD-9-CM code
434.91--Cerebral artery occlusion, unspecified with cerebral
infarction--should not be removed from the presumptive methodology list
because in order to be more specific the physiatrist would need to note
whether the stroke was embolic or thrombotic in nature. The commenters
stated that this is often unknown, even after radiological results.
Response: We recognize that the IRF builds its understanding of its
patients that are admitted to the IRF from the acute care hospital in
part from the acute care medical records, and that sometimes the
information needed to code a more specific diagnosis is not available
in those records. In the case of certain ICD-9-CM codes that we had
proposed to remove from the presumptive compliance list, we agree with
the commenters and have determined that the information necessary to
appropriately code certain conditions may not always be available. To
avoid diagnostic misclassification, we are revising our proposals in
Table 7 of the proposed rule and will retain codes 433.91 and 434.91 on
the list of codes that meet the presumptive compliance criteria. We may
revisit this decision in the future, if information to code the more
specific diagnosis codes becomes more readily available.
Though we agree with commenters that some information is either not
available or may not always be found in the documentation sent by the
acute care hospital and that this impacts the coding of some diagnoses,
we do not agree that this is the case for all the diagnosis codes
proposed for removal in Table 7 of the proposed rule or that the IRF
would not be able to obtain the necessary information through other
means in many instances. IRFs are required under the IRF coverage
requirements to conduct thorough preadmission screenings on all
prospective IRF patients prior to each IRF admission. During the
preadmission screenings, a complete medical chart review is required,
unless the patient is being assessed in person by the IRF personnel
conducting the preadmission screening. Even if the patient is being
assessed in person, a medical chart review is typically needed to
gather all of the pertinent information to complete a thorough
preadmission screening. Generally, diagnostic reports, radiological
reports, and consultation notes, among other informational
documentation are available in the acute care medical record to assist
IRF staff in building a more complete clinical picture so that
diagnostic coding, whenever possible, can be more specific. Even if
such information is not available in the acute care medical record,
however, we believe that the IRF should make every effort to obtain the
necessary information to code more specifically.
Comment: We received several comments on various non-specific
diagnosis codes that the commenters stated should not be removed from
the list. The commenters provided a variety of rationales for the
continued use of these codes to meet the presumptive compliance
criteria. For example, several commenters stated that the ICD-9-CM
codes related to hip fracture should not be excluded from the list. The
commenters stated that the specific information required to provide
where the fracture occurred on the neck of the femur is often not
available to IRF staff that do not have access to x-ray reports and
that such specificity would not impact the type of treatment in the
IRF. Several other commenters stated that we should reconsider the
proposed removal of some non-specific traumatic brain injury codes. The
commenters stated that the removal of these codes is ``administratively
unrealistic.'' The commenters also stated that for incidents of loss of
consciousness of short duration this information, usually documented by
on-site emergency technicians (when known), is no longer in the records
by the time the patient is admitted to the IRF. One commenter argued
that in cases of unobserved traumatic brain injury the duration of a
patient's loss of consciousness may never be specifically determined.
This commenter further stated that despite the absence of this
information, the patient may still be clinically appropriate for
intensive inpatient rehabilitation services.
Several commenters also argued that the identity of virus or
bacteria associated with diagnoses such as ICD-9-CM codes 049.9--
Unspecified non-arthropod-borne viral diseases of central nervous
system--, 320.9--Meningitis due to unspecified bacterium--, 322.9--
Meningitis, unspecified--, 323.9--Unspecified causes of encephalitis,
myelitis, and encephalomyelitis cannot frequently be found in the
medical records from the transferring hospital or in some cases may
never be known. As such, the commenters suggest that these codes not be
removed from the presumptive methodology list.
Several commenters stated that ICD-9-CM codes 343.9--Infantile
cerebral palsy, unspecified should not be removed from the presumptive
methodology list because many times
[[Page 47886]]
these patients are seen in IRFs as adults, when the patient's current
clinical presentation may be different from their original presentation
as infants. Moreover, the commenters argue, the adults may have no
available medical records that state the appropriate cerebral palsy
type. Similarly, these commenters argue that ICD-9-CM code 344.00--
Quadriplegia, unspecified should not be removed from the presumptive
methodology list because of the potential for a change from the
original presentation that was the basis of appropriate classification
of the level of completeness of the injury.
Response: Upon further review and after thoughtful consideration of
the comments we received, we have determined that several codes that we
proposed to remove from the ICD-9-CM Codes That Meet Presumptive
Compliance Criteria list should be retained. Thus, in this final rule
we will not remove these codes from the presumptive methodology list.
The ICD-9-CM codes that we proposed for removal from the ICD-9-CM Codes
That Meet Presumptive Compliance Criteria list, but we have determined
should be retained, are listed in Table 8. We also note here that we
inadvertently included 4 codes in Table 7 of the proposed rule that
were never on the ICD-9-CM Codes That Meet Presumptive Compliance
Criteria list. The codes are as follows: 804.00--Closed fractures
involving skull or face with other bones, without mention of
intracranial injury, unspecified state of consciousness--, 804.09--
Closed fractures involving skull of face with other bones, without
mention of intracranial injury, with concussion, unspecified--,
851.90--Other and unspecified cerebral laceration and contusion, with
open intracranial wound, unspecified state of consciousness--, 851.99--
Other and unspecified cerebral laceration and contusion, with open
intracranial wound, with concussion, unspecified.
Comment: Several commenters expressed concerns about our proposal
to remove ICD-9-CM code 356.9--Unspecified hereditary and idiopathic
peripheral neuropathy (IPN) from the ICD-9-CM Codes That Meet
Presumptive Compliance Criteria list because ``IPN is one of the most
common chronic neurologic disorders in America.'' One commenter further
stated that the precise etiology of a neuropathy has little effect on a
patient's rehabilitation, and that there are a limited number of codes
that can be used to specify the type of neuropathy.
Response: We believe that the fact that ICD-9-CM code 356.9--
Unspecified hereditary and idiopathic peripheral neuropathy (IPN)--is
such a commonly used code for multiple types of chronic neurological
disorders in the U.S. means that it is too broad a diagnosis to enable
us to determine whether a patient coded with this code meets the
criteria for the medical conditions that may be counted toward an IRF's
60 percent rule compliance percentage or not. We believe that some
patients coded with this code could meet the requirements in
412.29(b)(1), but others would not. That is, we believe that it is
impossible to tell from the possible application of this code to such a
broad and diverse population of patients whether patients coded with
this diagnosis code require intensive rehabilitation services for
treatment of one or more of the conditions specified at 42 CFR
412.29(b)(2). Our analysis shows that the percent of patients in IRFs
that are coded with this diagnosis code has increased substantially
over time (from 2.7 percent of all IRF patients in FY 2004 to 4.5
percent in FY 2012), with more dramatic increases occurring within
specific IRF providers. This finding may be the result of an increase
in the patient population for which this code applies, an increase in
the percent of patients with these conditions being admitted to the
IRF, or upcoding on the part of IRFs. Regardless, we believe that this
code does not provide enough information for us to determine whether a
patient coded with this diagnosis code would meet the requirements at
42 CFR 412.29(b). Thus, we believe that the most appropriate course of
action at this time is to remove this code from the presumptive
methodology list. However, we note that patients that are coded with
this diagnosis code may, where appropriate upon medical review, be
found to meet the criteria for the medical conditions that may be
counted toward a facility's 60 percent rule compliance percentage.
Table 8--ICD-9-CM Codes Retained in ``ICD-9-CM Codes That Meet
Presumptive Compliance Criteria'' \**\
------------------------------------------------------------------------
ICD-9-CM Code Diagnosis
------------------------------------------------------------------------
049.9.................... Unspecified non-arthropod-borne viral
diseases of central nervous system.
320.9.................... Meningitis due to unspecified bacterium.
322.9.................... Meningitis, unspecified.
323.9.................... Unspecified causes of encephalitis, myelitis,
and encephalomyelitis.
343.9.................... Infantile cerebral palsy, unspecified.
344.00................... Quadriplegia, unspecified.
433.91................... Occlusion and stenosis of unspecified
precerebral artery with cerebral infarction.
434.91................... Cerebral artery occlusion, unspecified with
cerebral infarction.
800.00................... Closed fracture of vault of skull without
mention of intracranial injury, unspecified
state of consciousness.
800.10................... Closed fracture of vault of skull with
cerebral laceration and contusion,
unspecified state of consciousness.
800.20................... Closed fracture of vault of skull with
subarachnoid, subdural, and extradural
hemorrhage, unspecified state of
consciousness.
800.30................... Closed fracture of vault of skull with other
and unspecified intracranial hemorrhage,
unspecified state of consciousness.
800.40................... Closed fracture of vault of skull with
intracranial injury of other and unspecified
nature, unspecified state of consciousness.
800.50................... Open fracture of vault of skull without
mention of intracranial injury, unspecified
state of consciousness.
800.60................... Open fracture of vault of skull with cerebral
laceration and contusion, unspecified state
of consciousness.
800.70................... Open fracture of vault of skull with
subarachnoid, subdural, and extradural
hemorrhage, unspecified state of
consciousness.
800.80................... Open fracture of vault of skull with other
and unspecified intracranial hemorrhage,
unspecified state of consciousness.
800.90................... Open fracture of vault of skull with
intracranial injury of other and unspecified
nature, unspecified state of consciousness.
801.00................... Closed fracture of base of skull without
mention of intra cranial injury, unspecified
state of consciousness.
801.10................... Closed fracture of base of skull with
cerebral laceration and contusion,
unspecified state of consciousness.
801.20................... Closed fracture of base of skull with
subarachnoid, subdural, and extradural
hemorrhage, unspecified state of
consciousness.
801.30................... Closed fracture of base of skull with other
and unspecified intracranial hemorrhage,
unspecified state of consciousness.
801.40................... Closed fracture of base of skull with
intracranial injury of other and unspecified
nature, unspecified state of consciousness.
801.50................... Open fracture of base of skull without
mention of intracranial injury, unspecified
state of consciousness.
801.60................... Open fracture of base of skull with cerebral
laceration and contusion, unspecified state
of consciousness.
[[Page 47887]]
801.70................... Open fracture of base of skull with
subarachnoid, subdural, and extradural
hemorrhage, unspecified state of
consciousness.
801.80................... Open fracture of base of skull with other and
unspecified intracranial hemorrhage,
unspecified state of consciousness.
801.90................... Open fracture of base of skull with
intracranial injury of other and unspecified
nature, unspecified state of consciousness.
803.00................... Other closed skull fracture without mention
of intracranial injury, unspecified state of
consciousness.
803.10................... Other closed skull fracture with cerebral
laceration and contusion, unspecified state
of consciousness.
803.20................... Other closed skull fracture with
subarachnoid, subdural, and extradural
hemorrhage, unspecified state of
consciousness.
803.30................... Other closed skull fracture with other and
unspecified intracranial hemorrhage,
unspecified state of unconsciousness.
803.40................... Other closed skull fracture with intracranial
injury of other and unspecified nature,
unspecified state of consciousness.
803.50................... Other open skull fracture without mention of
injury, unspecified state of consciousness.
803.60................... Other open skull fracture with cerebral
laceration and contusion, unspecified state
of consciousness.
803.70................... Other open skull fracture with subarachnoid,
subdural, and extradural hemorrhage,
unspecified state of consciousness.
803.80................... Other open skull fracture with other and
unspecified intracranial hemorrhage,
unspecified state of consciousness.
803.90................... Other open skull fracture with intracranial
injury of other and unspecified nature,
unspecified state of consciousness.
804.10................... Closed fractures involving skull or face with
other bones, with cerebral laceration and
contusion, unspecified state of
consciousness.
804.20................... Closed fractures involving skull or face with
other bones with subarachnoid, subdural, and
extradural hemorrhage, unspecified state of
consciousness.
804.30................... Closed fractures involving skull or face with
other bones, with other and unspecified
intracranial hemorrhage, unspecified state
of consciousness.
804.40................... Closed fractures involving skull or face with
other bones, with intracranial injury of
other and unspecified nature, unspecified
state of consciousness.
804.60................... Open fractures involving skull or face with
other bones, with cerebral laceration and
contusion, unspecified state of
consciousness.
804.70................... Open fractures involving skull or face with
other bones with subarachnoid, subdural, and
extradural hemorrhage, unspecified state of
consciousness.
804.80................... Open fractures involving skull or face with
other bones, with other and unspecified
intracranial hemorrhage, unspecified state
of consciousness.
804.90................... Open fractures involving skull or face with
other bones, with intracranial injury of
other and unspecified nature, unspecified
state of consciousness.
820.00................... Closed fracture of intracapsular section of
neck of femur, unspecified.
820.10................... Open fracture of intracapsular section of
neck of femur, unspecified.
820.30................... Open fracture of trochanteric section of neck
of femur, unspecified.
851.00................... Cortex (cerebral) contusion without mention
of open intracranial wound, unspecified
state of consciousness.
851.10................... Cortex (cerebral) contusion with open
intracranial wound, unspecified state of
consciousness.
851.20................... Cortex (cerebral) laceration without mention
of open intracranial wound, unspecified
state of consciousness.
851.30................... Cortex (cerebral) laceration with open
intracranial wound, unspecified state of
consciousness.
851.40................... Cerebellar or brain stem contusion without
mention of open intracranial wound,
unspecified state of consciousness.
851.50................... Cerebellar or brain stem contusion with open
intracranial wound, unspecified state of
consciousness.
851.60................... Cerebellar or brain stem laceration without
mention of open intracranial wound,
unspecified state of consciousness.
851.70................... Cerebellar or brain stem laceration with open
intracranial wound, unspecified state of
consciousness.
851.80................... Other and unspecified cerebral laceration and
contusion, without mention of open
intracranial wound, unspecified state of
consciousness.
852.00................... Subarachnoid hemorrhage following injury
without mention of open intracranial wound,
unspecified state of consciousness.
852.10................... Subarachnoid hemorrhage following injury with
open intracranial wound, unspecified state
of consciousness.
852.20................... Subdural hemorrhage following injury without
mention of open intracranial wound,
unspecified state of consciousness.
852.30................... Subdural hemorrhage following injury with
open intracranial wound, unspecified state
of consciousness.
852.40................... Extradural hemorrhage following injury
without mention of open intracranial wound,
unspecified state of consciousness.
852.50................... Extradural hemorrhage following injury with
open intracranial wound, unspecified state
of consciousness.
853.00................... Other and unspecified intracranial hemorrhage
following injury without mention of open
intracranial wound, unspecified state of
consciousness.
853.10................... Other and unspecified intracranial hemorrhage
following injury with open intracranial
wound, unspecified state of consciousness.
854.00................... Intracranial injury of other and unspecified
nature without mention of open intracranial
wound, unspecified state of consciousness.
854.10................... Intracranial injury of other and unspecified
nature with open intracranial wound,
unspecified state of consciousness.
------------------------------------------------------------------------
\**\ This table includes ICD-9-CM codes that were proposed (Table 7) in
the May 8, 2013 proposed rule for removal from ``ICD-9-CM Codes That
Meet Presumptive Compliance Criteria,'' but we have determined should
be retained.
2. Arthritis Codes
Our analysis of the list of ICD-9-CM codes that are currently
included in the presumptive methodology list revealed utilization
patterns that indicated that these codes were used far more frequently
than we had anticipated. We also realized that such codes did not
provide any information as to whether the patients met the severity and
prior treatment requirement portions of the criteria for the medical
conditions that may be counted toward an IRF's compliance percentage
under the presumptive compliance method. We did not adopt any and all
arthritis conditions in the May 7, 2004 final rule (69 FR 25752).
Rather, we only provided for those patients with certain kinds of
arthritic conditions that met defined severity and prior treatment
requirements. We anticipated that less severe arthritic conditions
could be satisfactorily managed outside of IRFs since these cases would
not require the intensive therapy provided in the
[[Page 47888]]
inpatient rehabilitation setting. As we realized on reflection that
there is no way to tell base on an arthritis ICD-9-CM code alone
whether an individual met the severity and prior treatment requirements
outlined in regulation, we realized that factors beyond the ICD-9-CM
code would need to be reviewed to establish whether these IRF patients
should be included in the IRF's compliance percentage.
Specifically, the regulations under Sec. 412.29(b)(2)(x) through
Sec. 412.29(b)(2)(xii), describe the following three (3) ``arthritis''
medical conditions that, if present, and all of the described
circumstances are met, would make a patient eligible for inclusion in
the presumptive compliance calculation of the IRF's compliance
percentage. The 3 medical conditions are as follows:
Active, polyarticular rheumatoid arthritis, psoriatic
arthritis, and seronegative arthropathies resulting in significant
functional impairment of ambulation and other activities of daily
living that have not improved after an appropriate, aggressive, and
sustained course of outpatient therapy services or services in other
less intensive rehabilitation settings immediately preceding the
inpatient rehabilitation admission or that result from a systemic
disease activation immediately before admission, but have the potential
to improve with more intensive rehabilitation.
Systemic vasculidities with joint inflammation, resulting
in significant functional impairment of ambulation and other activities
of daily living that have not improved after an appropriate,
aggressive, and sustained course of outpatient therapy services or
services in other less intensive rehabilitation settings immediately
preceding the inpatient rehabilitation admission or that result from a
systemic disease activation immediately before admission, but have the
potential to improve with more intensive rehabilitation.
Severe or advanced osteoarthritis (osteoarthrosis or
degenerative joint disease) involving two or more major weight bearing
joints (elbow, shoulders, hips, or knees, but not counting a joint with
a prosthesis) with joint deformity and substantial loss of range of
motion, atrophy of muscles surrounding the joint, significant
functional impairment of ambulation and other activities of daily
living that have not improved after the patient has participated in an
appropriate, aggressive, and sustained course of outpatient therapy
services or services in other less intensive rehabilitation settings
immediately preceding the inpatient rehabilitation admission but have
the potential to improve with more intensive rehabilitation. (A joint
replaced by a prosthesis is no longer is considered to have
osteoarthritis, or other arthritis, even though this condition was the
reason for the joint replacement.)
As stated above, the inclusion of patients with these medical
conditions in the presumptive compliance calculation of the IRF's
compliance percentage is conditioned on those patients meeting the
described severity and prior treatment requirements. However, the ICD-
9-CM diagnosis codes that reflect these arthritis and arthropathy
conditions do not provide any information about whether these
additional elements of the regulatory criteria were met. We therefore
believe that additional information beyond the presence of the code is
necessary to determine if the medical record would support inclusion of
individuals with the arthritis and arthropathy conditions outlined in
our regulations under Sec. 412.29(b)(2)(x) through Sec.
412.29(b)(2)(xii) in the presumptive compliance calculation of the
facility's compliance percentage. Thus, we proposed to remove the ICD-
9-CM diagnosis codes associated with the medical conditions outlined in
our regulations under Sec. 412.29(b)(2)(x) through Sec.
412.29(b)(2)(xii) from the presumptive methodology list.
We expect that the MACs will be able, upon medical review, to
include those patients in a facility's 60 percent rule compliance after
it has confirmed the severity and prior treatment portions of the
criteria. As such, IRFs would continue to be able to have these
individuals included in the medical review calculation of their
compliance percentages. In Table 9, we list the ICD-9-CM codes
associated with the medical conditions listed under Sec.
412.29(b)(2)(x) through Sec. 412.29(b)(2)(xii) that we will remove
from the list, ICD-9-CM Codes That Meet Presumptive Compliance
Criteria.
We received 11 comments on the proposed changes to arthritis
diagnosis codes listed in ICD-9-CM Codes That Meet Presumptive
Compliance Criteria, which are summarized below.
Comment: One commenter suggested that the proposed changes to the
presumptive methodology list and the removal of the arthritis codes
will increase the use of the medical review method, which is more
burdensome for both CMS and for IRFs. Several commenters suggested that
the facility should not have to undergo a ``full medical review'' if it
failed to meet the required compliance percentage using the presumptive
compliance method. Instead, they suggested use of a ``limited medical
review'' in which only arthritis and systemic vasculidities cases would
be reviewed. The commenters further stated that, should a sufficient
number of cases from the ``limited review'' be determined to meet
criteria, these ``passing'' records would be added to the ``numerator''
of the presumptive calculation result to arrive at a compliance
percentage equal at least 60 percent. In this manner the facility would
be deemed compliant without needing a ``full medical review.'' However,
if the IRF failed to meet criteria with this ``limited review,'' the
MAC could then perform a ``full medical review.''
Response: We acknowledge that because of the removal of the
arthritis codes from the list of codes that are used to determine
presumptive compliance under the ``60 percent'' rule, some facilities
may not be able to reach the minimum compliance percentage using
presumptive compliance method. In the May 8, 2013 proposed rule, we
suggested that upon medical review (in accordance with chapter 3,
section 140.1.4 of the Medicare Claims Processing Manual (Pub. 100-
04)), after which the MAC will have been able to determine that
severity and pretreatment requirements have been met, these patients
would be included in the calculation of a facility's 60 percent rule
compliance percentage. Assuming providers make no other changes, we
estimate that the removal of the arthritis and arthropathy codes will
result in approximately 40 facilities failing to meet the 60 percent
threshold using the presumptive compliance method, and would have to
instead be evaluated under the medical review method. We assume that
all of these facilities would obtain a satisfactory compliance
percentage after medical review, as we assume that the patients that
will be coded with the to-be removed arthritis and arthropathy codes
will meet the severity and prior treatment requirements. Thus, we
believe that few, if any facilities will ultimately lose their IRF
classification by virtue of these changes.
We appreciate the commenter's suggestions regarding the use of a
modified medical review limited to only arthritis and systemic
vasculidities cases to determine if patients have met severity and
pretreatment requirements, in lieu of full medical review carried out
in accordance with chapter 3, section 140.1.3(D), of the Medicare
Claims Processing Manual (Pub. 100-04). We will use the time afforded
by our one-year delay (that is, the application of the changes to the
list will not apply to
[[Page 47889]]
compliance review periods beginning before October 1, 2014) to consider
the feasibility of minimizing any burdens created by the operational
aspects of this policy.
Comment: One commenter expressed concern that in response to our
proposal to remove arthritis codes from the ICD-9-CM Codes That Meet
Presumptive Compliance Criteria list and no longer count them as part
of the presumptive methodology, IRFs will seek to avoid ``unnecessary''
medical review by modifying their admission criteria so as to limit the
admission of patients with arthritis conditions. The commenter also
stated that our proposed removal of the arthritis codes from the list
of presumptive ICD-9-CM codes that meet compliance criteria ``was as
if'' we removed arthritis and arthropathy conditions from the 13
qualifying medical conditions outlined in regulation.
Response: Although we agree that it is plausible that some IRFs
might seek to avoid the possibility of medical review by limiting
admission of patients with arthritis conditions, this is not our
intent. Our intent behind this policy is to ensure that we have enough
information to ensure patients with arthritis conditions who are
counted as meeting the compliance criteria in 412.29(b) are
appropriately meeting the severity and prior treatment requirements, as
per the regulation. We disagree that the proposed changes to the
presumptive methodology list equates with the removal of arthritis and
arthropathy conditions from the 13 qualifying medical conditions
outlined in regulation. As discussed in the proposed rule's preamble
and in prior discussion in this preamble, when we adopted the arthritis
and arthropathy conditions in the May 7, 2004 final rule, we limited
the conditions to those that met defined severity and prior treatment
requirements, and that were sufficiently severe as to require intensive
inpatient rehabilitation services. As discussed above, ICD-9-CM
diagnosis codes alone do not provide sufficient information to
establish whether these pretreatment and severity requirements have
been met. More detailed information is necessary to determine if the
patient meets the pretreatment and severity requirements. Verification
using the medical review compliance method will allow an IRF to have
these patients included in their compliance percentage. Thus, arthritis
conditions will continue to be included in the calculation of
compliance percentages in accordance with the 13 qualifying medical
conditions in the regulations.
3. Some Congenital Anomaly Diagnosis Codes
Though congenital deformity is one of the 13 medical conditions
that may, subject to the limitations spelled out in the regulations,
qualify for inclusion in the calculation of an IRF's compliance
percentage under the 60 percent rule, certain congenital anomalies
represent such serious conditions that a patient with one of these
conditions would generally not be expected to be able to meaningfully
participate in an intensive rehabilitation therapy program. For
example, Craniorachischisis (ICD-9-CM code 740.1) is a congenital
malformation where the neural tube from the midbrain down to the upper
sacral region of the spinal cord remains open. The neural tube is the
embryo's precursor to the central nervous system, which comprises the
brain and spinal cord. Similarly, Iniencephaly (ICD-9-CD code 740.2) is
a congenital malformation in which parts of the brain do not form and
the patient does not have a neck. Because beneficiaries with these
diagnoses likely would generally not be expected to be able to actively
participate in an intensive rehabilitation program, we do not believe
that we can include such cases in an IRF's presumptive compliance
percentage. That said, as we noted in the proposed rule, if a patient
with one of these conditions were able to participate in the intensive
rehabilitation services provided in an IRF, then the MAC would be able
to count that case toward an IRF's 60 percent rule compliance
percentage upon medical review. Thus, we proposed the removal of these
congenital deformity codes, and others that present similar concerns
that were discussed in the proposed rule from the presumptive
compliance list.
We received 4 comments on the proposed changes to the congenital
anomaly diagnosis codes, which are summarized below.
Comment: The commenters supported our proposal to remove the
specified congenital anomaly conditions from the presumptive
methodology list. These commenters noted that these conditions are rare
and agreed that patients with these conditions would be unlikely to
require or to meaningfully participate in intensive inpatient
rehabilitation services.
Response: We thank the commenters for supporting our efforts to
refine the presumptive methodology list so that the list truly
represents diagnoses that would be expected to indicate that an
individual meets the medical condition criteria, and that they should
be included in an IRF's compliance percentage under the presumptive
compliance method of calculating a compliance percentage. All of the
congenital anomaly diagnosis codes that we are removing from ICD-9-CM
Codes That Meet Presumptive Compliance Criteria list are listed in
Table 9.
4. Unilateral Upper Extremity Amputations Diagnosis Codes
Though amputation is generally one of the 13 medical conditions
that qualify for inclusion in the an IRF's compliance calculation for
the 60 percent rule, we proposed the removal of certain ICD-9-CM codes
for unilateral upper extremity amputations from the presumptive
methodology list, ICD-9-CM Codes That Meet Presumptive Compliance
Criteria, because we believe that it is impossible to determine, from
the presence of such ICD-9-CM codes alone, whether a patient with such
a unilateral upper extremity amputation has a condition for which he or
she would need intensive rehabilitation services for treatment of one
or more of the conditions specified in Sec. 412.29(b)(2). We expect
that some patients with these upper extremity amputations will not
require close medical supervision by a physician or weekly
interdisciplinary team conferences to achieve their goals, while others
may require these services. But we generally believe that
rehabilitation associated with unilateral upper extremity amputations
would not need to be accompanied by the close medical management
provided in IRFs, as long as the patient does not have any additional
comorbidities that have caused significant decline in his or her
functional ability that, in the absence of the unilateral upper
extremity amputation, would necessitate treatment in an IRF. That is to
say, a patient's need for intensive rehabilitation services provided in
an IRF depends on other conditions which cannot be solely identified
through the presence of a unilateral upper extremity amputation ICD-9-
CM code. If the patient has comorbidities that would necessitate
treatment in an IRF, then those comorbidities would qualify the patient
for inclusion under the presumptive compliance method of calculating
compliance with the 60 percent rule if one or more of the comorbidities
are on the presumptive methodology list. If the codes for such a
patient's comorbidities do not appear in the presumptive compliance
list, the patient can still be considered for inclusion in the IRF's
compliance percentage following medical review and confirmation that
they meet the
[[Page 47890]]
criteria for one or more of the medical conditions in the regulations.
Thus, we proposed to remove the unilateral upper extremity amputation
from the presumptive methodology list.
We received 5 comments on the proposed changes to unilateral upper
extremity amputation diagnosis codes listed in ICD-9-CM Codes That Meet
Presumptive Compliance Criteria, which are summarized below.
Comment: Several commenters supported our proposal to remove
unilateral upper extremity amputation codes from ICD-9-CM Codes That
Meet Presumptive Compliance. The commenters agreed with our assessment
that a patient's need for intensive inpatient rehabilitative services
for the treatment of one or more of these conditions would depend on
the presence of additional comorbidities that caused significant
decline in his or her functional ability to the extent that the patient
would necessitate treatment in an IRF. However, one commenter disagreed
with the proposal because an inpatient setting offering an intensive
rehabilitation therapy program would be appropriate for the acute phase
of wound healing, edema control, and desensitization and pain control
that these patients may require.
Response: We agree that unilateral upper extremity amputation
patients have ongoing therapy needs and may require medical aftercare
once discharged from an acute hospital stay. However, as long as the
patient does not have any other comorbidities that have caused
significant decline in his or her functional ability that, in the
absence of the unilateral upper extremity amputation, would require
treatment in an IRF, we do not believe that the patient could be
presumed to meet the regulatory requirements for inclusion in an IRF's
compliance percentage.
5. Miscellaneous Diagnosis Codes That Do Not Require Intensive
Rehabilitation Services for Treatment
We have identified additional ICD-9-CM diagnosis codes in the
presumptive methodology list, ICD-9-CM Codes That Meet Presumptive
Compliance Criteria, which do not, in the absence of additional
confirmatory information, indicate a patient's need for intensive
rehabilitation services or that they have met any severity or
prerequisite treatment requirements for the medical conditions that may
be counted toward an IRF's compliance percentage. We therefore proposed
removal of the following ICD-9-CM codes from the list, ICD-9-CM Codes
That Meet Presumptive Compliance Criteria.
Tuberculous (abscess, meningitis, and encephalitis or
myelitis) and Tuberculoma (of the meninges, brain, or spinal cord)
where a bacterial or histological examination is unspecified or was not
done (see Table 7 in the proposed rule for a list of the specific
codes)--Appropriate patient care dictates that the IRF physician must
attempt to ascertain the means by which the organism, whether it be
bacteriologic or histologic, was tested. We expect the IRF physician to
make a good faith effort to determine the type of diagnostic test which
identified the tuberculous organism. In the circumstances where this is
impossible (that is, documentation no longer exists), appropriate codes
remain on the presumptive methodology list. However, we expect the IRF
physician to make a good faith effort to determine the type of
diagnostic test which identified the tuberculous organism. We therefore
proposed to remove these unspecified codes from the list, ICD-9-CM
Codes That Meet Presumptive Compliance Criteria.
Postherpetic polyneuropathy (053.13)--This is a condition
characterized by severe pain, which typically requires pain medication
or other pain control therapies but does not typically require the
intensive inpatient rehabilitation services of an IRF. In fact, the
prescriptive hands-on therapeutic interventions provided in an IRF
could exacerbate the patient's pain. For these reasons, we proposed the
removal of this code from ICD-9-CM Codes That Meet Presumptive
Compliance Criteria.
Louping ill (063.1)--This ICD-9-CM code refers to an acute
viral disease primarily of sheep that is not endemic to the United
States. Louping ill disease has been recognized in Scotland for
centuries, but only 39 cases of human infection have been described and
none of these cases have been observed in the United States. Louping
ill is a disease which has many manifestations, not all requiring
inpatient rehabilitation hospital services. We believe that the ICD-9-
CM code for this diagnosis does not provide the information necessary
for us to determine presumptively whether the patient has met the
criteria for the medical conditions that may be counted toward an IRF's
compliance percentage. However, as with all of the codes that we
proposed removing from the list, ICD-9-CM Codes That Meet Presumptive
Compliance Criteria, if someone with this diagnosis were to be admitted
to an IRF, medical review could be used to confirm whether the
regulatory criteria have been met.
Brain death (348.82)--We believe that it is unlikely that
a patient with this condition would require the intensive inpatient
rehabilitation services provided in an IRF. For this reason, we
proposed the removal of this code from ICD-9-CM Codes That Meet
Presumptive Compliance Criteria.
Myasthenia gravis without (acute) exacerbation (358.00)--
Although we believe that a patient experiencing an acute attack of
Myasthenia Gravis could potentially require the intensive inpatient
rehabilitative services of an IRF (these individuals are coded with
ICD-9 code 358.01 ``Myasthenia gravis with (acute) exacerbation''), we
proposed the removal of non-acute myasthenia gravis from the list, ICD-
9-CM Codes That Meet Presumptive Compliance Criteria because such
patients would not be experiencing an acute exacerbation of the
condition and most likely would not require the intensive inpatient
rehabilitation services provided in an IRF.
Other specified myotonic disorder (359.29)--codes patients
with Myotonia fluctuans, myotonia permanens, and paramyotonia
congenital which are conditions that are exacerbated by exercise. The
intensive inpatient rehabilitation services of an IRF would be expected
to exacerbate these conditions, so such care would likely be
contraindicated. Therefore, we proposed the removal of this code from
the list, ICD-9-CM Codes That Meet Presumptive Compliance Criteria.
Periodic paralysis (359.3)--The treatment for periodic
paralysis involves pharmaceutical interventions and lifestyle changes
that control exercise and activity, but patients with this condition do
not generally require the intensive inpatient rehabilitation services
of an IRF. In fact, it is unclear how the intensive inpatient
rehabilitation services provided in an IRF would effectively treat this
condition. Thus, we proposed the removal of this code from the list,
ICD-9-CM Codes That Meet Presumptive Compliance Criteria.
Brachial plexus lesions (353.0)--Care and treatment for
this condition, which affects an upper extremity in a manner that
typically does not require close medical supervision by a physician or
weekly interdisciplinary team meetings to reach the patient's goals,
would not be expect to require the intensive inpatient rehabilitation
services provided in an IRF. Therefore, we proposed the removal of this
code from the list, ICD-9-CM Codes That Meet Presumptive Compliance
Criteria.
Neuralgic amyothrophy (353.5)--This condition is also
known as
[[Page 47891]]
Parsonage-Turner syndrome or brachial plexus neuritis. It is a distinct
peripheral nervous system disorder characterized by attacks of extreme
neuropathic pain and rapid multifocal weakness and atrophy in the upper
limbs. Patients with this condition do not typically require close
medical supervision by a physician or weekly interdisciplinary team
meetings to reach the patient's therapy goals. Thus, patients with this
condition do not typically require the intensive inpatient
rehabilitation services provided in an IRF. Therefore, we proposed the
removal of this code from the list, ICD-9-CM Codes That Meet
Presumptive Compliance Criteria.
Other nerve root and plexus disorders (353.8)--This code
does not, in the absence of additional information, reveal whether a
patient is in need of intensive rehabilitation services for treatment
of one or more of the conditions specified in the regulations. More
descriptive codes should be used so as to document the appropriateness
of a patient's IRF admission, and potentially, their inclusion in the
IRF's compliance percentage. For example, Lumbosacral plexus lesions
(353.1) could substitute for Other nerve root and plexus disorders
(353.8). Patients with lumbosacral plexus lesions, however, do not
typically require the intensive inpatient rehabilitation services
provided in an IRF. Therefore, we proposed the removal of this code
from the list, ICD-9-CM Codes That Meet Presumptive Compliance
Criteria.
We received 3 comments on the proposed changes to the miscellaneous
diagnosis codes that we proposed removing from the presumptive
methodology list in the proposed rule. These are summarized below.
Comment: The commenters agreed with the proposed removal of the
miscellaneous diagnosis codes that were discussed in the May 8, 2013
proposed rule.
Response: We appreciate the commenters support and thank them for
their comments.
6. Additional Diagnosis Codes
During our review of the diagnosis codes on the presumptive
methodology list we did not identify any ICD-9-CM codes that would be
appropriate to add to the list. However, we welcomed public comment
regarding ICD-9-CM diagnosis codes that are not currently on the
presumptive methodology list that stakeholders believe should be added.
We noted that any such suggested codes would have to code for one of
the medical conditions listed at Sec. 412.29(b)(2) (including any
severity or pretreatment requirements), and require intensive inpatient
rehabilitation.
We received one comment suggesting additional diagnosis codes not
currently listed in ICD-9-CM Codes That Meet Presumptive Compliance
Criteria..
Comment: The commenter suggested that we add ICD-9-CM code 348.31--
Metabolic encephalopathy and ICD-9-CM code 331.83--Parkinson's
Dementia--to the list of qualifying codes.
Response: We agree that code ICD-9-CM code 348.31--Metabolic
encephalopathy-- should be added to the list with the other toxic
encephalopathy codes to ensure that IRFs can code to the highest level
of specificity. We will add this code to the list of ICD-9-CM Codes
That Meet Presumptive Compliance Criteria. However, we disagree with
the commenter's suggestion to add Parkinson's Dementia to the list of
codes because we cannot determine ``presumptively'' whether these
patients would be able to meaningfully participate in an intensive
inpatient rehabilitation program.
Final Decision: After carefully considering the comments that we
received on the proposed changes to the ICD-9-CM in the presumptive
methodology list, we are revising the list of ICD-9-CM codes to be
removed from ``ICD-9-CM Codes That Meet Presumptive Compliance
Criteria'' as follows: We are removing the codes listed in Table 9 of
this final rule. We are also adding ICD-9-CM code 348.31--Metabolic
encephalopathy to the presumptive methodology list. The revisions to
the list of diagnosis codes that are used to determine presumptive
compliance under the ``60 percent rule'' are effective for compliance
review periods beginning on or after October 1, 2014.
Table 9--ICD-9-CM Codes Removed From ``ICD-9-CM Codes That Meet
Presumptive Compliance Criteria''
------------------------------------------------------------------------
ICD-9-CM Code Diagnosis
------------------------------------------------------------------------
013.00................... Tuberculous meningitis, unspecified.
013.01................... Tuberculous meningitis, bacteriological or
histological examination not done.
013.10................... Tuberculoma of meninges, unspecified.
013.11................... Tuberculoma of meninges, bacteriological or
histological examination not done.
013.20................... Tuberculoma of brain, unspecified.
013.21................... Tuberculoma of brain, bacteriological or
histological examination not done.
013.30................... Tuberculous abscess of brain, unspecified.
013.31................... Tuberculous abscess of brain, bacteriological
or histological examination not done.
013.40................... Tuberculoma of spinal cord, unspecified.
013.41................... Tuberculoma of spinal cord, bacteriological
or histological examination not done.
013.50................... Tuberculous abscess of spinal cord,
unspecified.
013.51................... Tuberculous abscess of spinal cord,
bacteriological or histological examination
not done.
013.60................... Tuberculous encephalitis or myelitis,
unspecified.
013.61................... Tuberculous encephalitis or myelitis,
bacteriological or histological examination
not done.
047.9.................... Unspecified viral meningitis.
053.13................... Postherpetic polyneuropathy.
062.9.................... Mosquito-borne viral encephalitis,
unspecified.
063.1.................... Louping ill.
063.9.................... Tick-borne viral encephalitis, unspecified.
324.9.................... Intracranial and intraspinal abscess of
unspecified site.
335.10................... Spinal muscular atrophy, unspecified.
335.9.................... Anterior horn cell disease, unspecified.
336.9.................... Unspecified disease of spinal cord.
341.9.................... Demyelinating disease of central nervous
system, unspecified.
342.00................... Flaccid hemiplegia and hemiparesis affecting
unspecified side.
342.10................... Spastic hemiplegia and hemiparesis affecting
unspecified side.
[[Page 47892]]
342.80................... Other specified hemiplegia and hemiparesis
affecting unspecified side.
342.90................... Hemiplegia, unspecified, affecting
unspecified side.
342.91................... Hemiplegia, unspecified, affecting dominant
side.
342.92................... Hemiplegia, unspecified, affecting
nondominant side.
343.3.................... Congenital monoplegia.
344.5.................... Unspecified monoplegia.
348.82................... Brain death.
353.0.................... Brachial plexus lesions.
353.2.................... Cervical root lesions, not elsewhere
classified.
353.3.................... Thoracic root lesions, not elsewhere
classified.
353.4.................... Lumbosacral root lesions, not elsewhere
classified.
353.5.................... Neuralgic amyotrophy.
353.8.................... Other nerve root and plexus disorders.
354.5.................... Mononeuritis multiplex.
356.9.................... Unspecified hereditary and idiopathic
peripheral neuropathy.
358.00................... Myasthenia gravis without (acute)
exacerbation.
359.29................... Other specified myotonic disorder.
359.3.................... Periodic paralysis.
432.9.................... Unspecified intracranial hemorrhage.
438.20................... Late effects of cerebrovascular disease,
hemiplegia affecting unspecified side.
438.30................... Late effects of cerebrovascular disease,
monoplegia of upper limb affecting
unspecified side.
438.31................... Late effects of cerebrovascular disease,
monoplegia of upper limb affecting dominant
side.
438.32................... Late effects of cerebrovascular disease,
monoplegia of upper limb affecting
nondominant side.
438.40................... Late effects of cerebrovascular disease,
monoplegia of lower limb affecting
unspecified side.
438.50................... Late effects of cerebrovascular disease,
other paralytic syndrome affecting
unspecified side.
446.0.................... Polyarteritis nodosa.
711.20................... Arthropathy in Behcet's syndrome, site
unspecified.
711.21................... Arthropathy in Behcet's syndrome, shoulder
region.
711.22................... Arthropathy in Behcet's syndrome, upper arm.
711.23................... Arthropathy in Behcet's syndrome, forearm.
711.24................... Arthropathy in Behcet's syndrome, hand.
711.25................... Arthropathy in Behcet's syndrome, pelvic
region and thigh.
711.26................... Arthropathy in Behcet's syndrome, lower leg.
711.27................... Arthropathy in Behcet's syndrome, ankle and
foot.
711.28................... Arthropathy in Behcet's syndrome, other
specified sites.
711.29................... Arthropathy in Behcet's syndrome, multiple
sites.
713.0.................... Arthropathy associated with other endocrine
and metabolic disorders.
713.1.................... Arthropathy associated with gastrointestinal
conditions other than infections.
713.2.................... Arthropathy associated with hematological
disorders.
713.3.................... Arthropathy associated with dermatological
disorders.
713.4.................... Arthropathy associated with respiratory
disorders.
713.6.................... Arthropathy associated with hypersensitivity
reaction.
713.7.................... Other general diseases with articular
involvement.
714.0.................... Rheumatoid arthritis.
714.1.................... Felty's syndrome.
714.2.................... Other rheumatoid arthritis with visceral or
systemic involvement.
714.32................... Pauciarticular juvenile rheumatoid arthritis.
714.81................... Rheumatoid lung.
714.89................... Other specified inflammatory
polyarthropathies.
714.9.................... Unspecified inflammatory polyarthropathy.
715.11................... Osteoarthrosis, localized, primary, shoulder
region.
715.12................... Osteoarthrosis, localized, primary, upper
arm.
715.15................... Osteoarthrosis, localized, primary, pelvic
region and thigh.
715.16................... Osteoarthrosis, localized, primary, lower
leg.
715.21................... Osteoarthrosis, localized, secondary,
shoulder region.
715.22................... Osteoarthrosis, localized, secondary, upper
arm.
715.25................... Osteoarthrosis, localized, secondary, pelvic
region and thigh.
715.26................... Osteoarthrosis, localized, secondary, lower
leg.
715.31................... Osteoarthrosis, localized, not specified
whether primary or secondary, shoulder
region.
715.32................... Osteoarthrosis, localized, not specified
whether primary or secondary, upper arm.
715.35................... Osteoarthrosis, localized, not specified
whether primary or secondary, pelvic region
and thigh.
715.36................... Osteoarthrosis, localized, not specified
whether primary or secondary, lower leg.
716.01................... Kaschin-Beck disease, shoulder region.
716.02................... Kaschin-Beck disease, upper arm.
716.05................... Kaschin-Beck disease, pelvic region and
thigh.
716.06................... Kaschin-Beck disease, lower leg.
716.11................... Traumatic arthropathy, shoulder region.
716.12................... Traumatic arthropathy, upper arm.
716.15................... Traumatic arthropathy, pelvic region and
thigh.
716.16................... Traumatic arthropathy, lower leg.
[[Page 47893]]
716.21................... Allergic arthritis, shoulder region.
716.22................... Allergic arthritis, upper arm.
716.25................... Allergic arthritis, pelvic region and thigh.
716.26................... Allergic arthritis, lower leg.
716.51................... Unspecified polyarthropathy or polyarthritis,
shoulder region.
716.52................... Unspecified polyarthropathy or polyarthritis,
upper arm.
716.55................... Unspecified polyarthropathy or polyarthritis,
pelvic region and thigh.
716.56................... Unspecified polyarthropathy or polyarthritis,
lower leg.
719.30................... Palindromic rheumatism, site unspecified.
719.31................... Palindromic rheumatism, shoulder region.
719.32................... Palindromic rheumatism, upper arm.
719.33................... Palindromic rheumatism, forearm.
719.34................... Palindromic rheumatism, hand.
719.35................... Palindromic rheumatism, pelvic region and
thigh.
719.36................... Palindromic rheumatism, lower leg.
719.37................... Palindromic rheumatism, ankle and foot.
719.38................... Palindromic rheumatism, other specified
sites.
719.39................... Palindromic rheumatism, multiple sites.
720.0.................... Ankylosing spondylitis.
720.81................... Inflammatory spondylopathies in diseases
classified elsewhere.
720.89................... Other inflammatory spondylopathies.
721.91................... Spondylosis of unspecified site, with
myelopathy.
722.70................... Intervertebral disc disorder with myelopathy,
unspecified region.
740.1.................... Craniorachischisis.
740.2.................... Iniencephaly.
741.00................... Spina bifida with hydrocephalus, unspecified
region.
741.90................... Spina bifida without mention of
hydrocephalus, unspecified region.
742.1.................... Microcephalus.
754.30................... Congenital dislocation of hip, unilateral.
754.31................... Congenital dislocation of hip, bilateral.
754.32................... Congenital subluxation of hip, unilateral.
755.20................... Unspecified reduction deformity of upper
limb.
755.21................... Transverse deficiency of upper limb.
755.22................... Longitudinal deficiency of upper limb, not
elsewhere classified.
755.23................... Longitudinal deficiency, combined, involving
humerus, radius, and ulna (complete or
incomplete).
755.24................... Longitudinal deficiency, humeral, complete or
partial (with or without distal
deficiencies, incomplete).
755.25................... Longitudinal deficiency, radioulnar, complete
or partial (with or without distal
deficiencies, incomplete).
755.26................... Longitudinal deficiency, radial, complete or
partial (with or without distal
deficiencies, incomplete).
755.27................... Longitudinal deficiency, ulnar, complete or
partial (with or without distal
deficiencies, incomplete).
755.28................... Longitudinal deficiency, carpals or
metacarpals, complete or partial (with or
without incomplete phalangeal deficiency).
755.30................... Unspecified reduction deformity of lower
limb.
755.4.................... Reduction deformities, unspecified limb.
755.51................... Congenital deformity of clavicle.
755.53................... Radioulnar synostosis.
755.61................... Coxa valga, congenital.
755.62................... Coxa vara, congenital.
755.63................... Other congenital deformity of hip (joint).
756.50................... Congenital osteodystrophy, unspecified.
800.09................... Closed fracture of vault of skull without
mention of intracranial injury, with
concussion, unspecified.
800.19................... Closed fracture of vault of skull with
cerebral laceration and contusion, with
concussion, unspecified.
800.29................... Closed fracture of vault of skull with
subarachnoid, subdural, and extradural
hemorrhage, with concussion, unspecified.
800.39................... Closed fracture of vault of skull with other
and unspecified intracranial hemorrhage,
with concussion, unspecified.
800.49................... Closed fracture of vault of skull with
intracranial injury of other and unspecified
nature, with concussion, unspecified.
800.59................... Open fracture of vault of skull without
mention of intracranial injury, with
concussion, unspecified.
800.69................... Open fracture of vault of skull with cerebral
laceration and contusion, with concussion,
unspecified.
800.79................... Open fracture of vault of skull with
subarachnoid, subdural, and extradural
hemorrhage, with concussion, unspecified.
800.89................... Open fracture of vault of skull with other
and unspecified intracranial hemorrhage,
with concussion, unspecified.
800.99................... Open fracture of vault of skull with
intracranial injury of other and unspecified
nature, with concussion, unspecified.
801.09................... Closed fracture of base of skull without
mention of intra cranial injury, with
concussion, unspecified.
801.19................... Closed fracture of base of skull with
cerebral laceration and contusion, with
concussion, unspecified.
801.29................... Closed fracture of base of skull with
subarachnoid, subdural, and extradural
hemorrhage, with concussion, unspecified.
801.39................... Closed fracture of base of skull with other
and unspecified intracranial hemorrhage,
with concussion, unspecified.
801.49................... Closed fracture of base of skull with
intracranial injury of other and unspecified
nature, with concussion, unspecified.
801.59................... Open fracture of base of skull without
mention of intracranial injury, with
concussion, unspecified.
801.69................... Open fracture of base of skull with cerebral
laceration and contusion, with concussion,
unspecified.
801.79................... Open fracture of base of skull with
subarachnoid, subdural, and extradural
hemorrhage, with concussion, unspecified.
801.89................... Open fracture of base of skull with other and
unspecified intracranial hemorrhage, with
concussion, unspecified.
801.99................... Open fracture of base of skull with
intracranial injury of other and unspecified
nature, with concussion, unspecified.
803.09................... Other closed skull fracture without mention
of intracranial injury, with concussion,
unspecified.
803.19................... Other closed skull fracture with cerebral
laceration and contusion, with concussion,
unspecified.
[[Page 47894]]
803.29................... Other closed skull fracture with
subarachnoid, subdural, and extradural
hemorrhage, with concussion, unspecified.
803.39................... Other closed skull fracture with other and
unspecified intracranial hemorrhage, with
concussion, unspecified.
803.49................... Other closed skull fracture with intracranial
injury of other and unspecified nature, with
concussion, unspecified.
803.59................... Other open skull fracture without mention of
intracranial injury, with concussion,
unspecified.
803.69................... Other open skull fracture with cerebral
laceration and contusion, with concussion,
unspecified.
803.79................... Other open skull fracture with subarachnoid,
subdural, and extradural hemorrhage, with
concussion, unspecified.
803.89................... Other open skull fracture with other and
unspecified intracranial hemorrhage, with
concussion, unspecified.
803.99................... Other open skull fracture with intracranial
injury of other and unspecified nature, with
concussion, unspecified.
804.19................... Closed fractures involving skull or face with
other bones, with cerebral laceration and
contusion, with concussion, unspecified.
804.29................... Closed fractures involving skull or face with
other bones with subarachnoid, subdural, and
extradural hemorrhage, with concussion,
unspecified.
804.39................... Closed fractures involving skull or face with
other bones, with other and unspecified
intracranial hemorrhage, with concussion,
unspecified.
804.49................... Closed fractures involving skull or face with
other bones, with intracranial injury of
other and unspecified nature, with
concussion, unspecified.
804.69................... Open fractures involving skull or face with
other bones, with cerebral laceration and
contusion, with concussion, unspecified.
804.79................... Open fractures involving skull or face with
other bones with subarachnoid, subdural, and
extradural hemorrhage, with concussion,
unspecified.
804.89................... Open fractures involving skull or face with
other bones, with other and unspecified
intracranial hemorrhage, with concussion,
unspecified.
804.99................... Open fractures involving skull or face with
other bones, with intracranial injury of
other and unspecified nature, with
concussion, unspecified.
806.00................... Closed fracture of C1-C4 level with
unspecified spinal cord injury.
806.05................... Closed fracture of C5-C7 level with
unspecified spinal cord injury.
806.10................... Open fracture of C1-C4 level with unspecified
spinal cord injury.
806.15................... Open fracture of C5-C7 level with unspecified
spinal cord injury.
806.20................... Closed fracture of T1-T6 level with
unspecified spinal cord injury.
806.25................... Closed fracture of T7-T12 level with
unspecified spinal cord injury.
806.30................... Open fracture of T1-T6 level with unspecified
spinal cord injury.
806.35................... Open fracture of T7-T12 level with
unspecified spinal cord injury.
806.60................... Closed fracture of sacrum and coccyx with
unspecified spinal cord injury.
806.70................... Open fracture of sacrum and coccyx with
unspecified spinal cord injury.
820.8.................... Closed fracture of unspecified part of neck
of femur.
820.9.................... Open fracture of unspecified part of neck of
femur.
839.10................... Open dislocation, cervical vertebra,
unspecified.
850.5.................... Concussion with loss of consciousness of
unspecified duration.
851.09................... Cortex (cerebral) contusion without mention
of open intracranial wound, with concussion,
unspecified.
851.19................... Cortex (cerebral) contusion with open
intracranial wound, with concussion,
unspecified.
851.29................... Cortex (cerebral) laceration without mention
of open intracranial wound, with concussion,
unspecified.
851.39................... Cortex (cerebral) laceration with open
intracranial wound, with concussion,
unspecified.
851.49................... Cerebellar or brain stem contusion without
mention of open intracranial wound, with
concussion, unspecified.
851.59................... Cerebellar or brain stem contusion with open
intracranial wound, with concussion,
unspecified.
851.69................... Cerebellar or brain stem laceration without
mention of open intracranial wound, with
concussion, unspecified.
851.79................... Cerebellar or brain stem laceration with open
intracranial wound, with concussion,
unspecified.
851.89................... Other and unspecified cerebral laceration and
contusion, without mention of open
intracranial wound, with concussion,
unspecified.
852.09................... Subarachnoid hemorrhage following injury
without mention of open intracranial wound,
with concussion, unspecified.
852.19................... Subarachnoid hemorrhage following injury with
open intracranial wound, with concussion,
unspecified.
852.29................... Subdural hemorrhage following injury without
mention of open intracranial wound, with
concussion, unspecified.
852.39................... Subdural hemorrhage following injury with
open intracranial wound, with concussion,
unspecified.
852.49................... Extradural hemorrhage following injury
without mention of open intracranial wound,
with concussion, unspecified.
852.59................... Extradural hemorrhage following injury with
open intracranial wound, with concussion,
unspecified.
853.09................... Other and unspecified intracranial hemorrhage
following injury without mention of open
intracranial wound, with concussion,
unspecified.
853.19................... Other and unspecified intracranial hemorrhage
following injury with open intracranial
wound, with concussion, unspecified.
854.09................... Intracranial injury of other and unspecified
nature without mention of open intracranial
wound, with concussion, unspecified.
854.19................... Intracranial injury of other and unspecified
nature with open intracranial wound, with
concussion, unspecified.
887.0.................... Traumatic amputation of arm and hand
(complete) (partial), unilateral, below
elbow, without mention of complication.
887.1.................... Traumatic amputation of arm and hand
(complete) (partial), unilateral, below
elbow, complicated.
887.2.................... Traumatic amputation of arm and hand
(complete) (partial), unilateral, at or
above elbow, without mention of
complication.
887.3.................... Traumatic amputation of arm and hand
(complete) (partial), unilateral, at or
above elbow, complicated.
887.4.................... Traumatic amputation of arm and hand
(complete) (partial), unilateral, level not
specified, without mention of complication.
887.5.................... Traumatic amputation of arm and hand
(complete) (partial), unilateral, level not
specified, complicated.
941.00................... Burn of unspecified degree of face and head,
unspecified site.
941.02................... Burn of unspecified degree of eye (with other
parts of face, head, and neck).
941.09................... Burn of unspecified degree of multiple sites
[except with eye] of face, head, and neck.
942.00................... Burn of unspecified degree of trunk,
unspecified site.
942.01................... Burn of unspecified degree of breast.
942.02................... Burn of unspecified degree of chest wall,
excluding breast and nipple.
942.03................... Burn of unspecified degree of abdominal wall.
[[Page 47895]]
942.04................... Burn of unspecified degree of back [any
part].
942.05................... Burn of unspecified degree of genitalia.
942.09................... Burn of unspecified degree of other and
multiple sites of trunk.
943.00................... Burn of unspecified degree of upper limb,
except wrist and hand, unspecified site.
943.01................... Burn of unspecified degree of forearm.
943.02................... Burn of unspecified degree of elbow.
943.03................... Burn of unspecified degree of upper arm.
943.04................... Burn of unspecified degree of axilla.
943.05................... Burn of unspecified degree of shoulder.
943.06................... Burn of unspecified degree of scapular
region.
943.09................... Burn of unspecified degree of multiple sites
of upper limb, except wrist and hand.
943.30................... Full-thickness skin [third degree, not
otherwise specified] of upper limb,
unspecified site.
943.40................... Deep necrosis of underlying tissues [deep
third degree] without mention of loss of a
body part, of upper limb, unspecified site.
943.50................... Deep necrosis of underlying tissues [deep
third degree] with loss of a body part, of
upper limb, unspecified site.
944.30................... Full-thickness skin loss [third degree, not
otherwise specified] of hand, unspecified
site.
944.40................... Deep necrosis of underlying tissues [deep
third degree] without mention of loss of a
body part, hand, unspecified site.
944.50................... Deep necrosis of underlying tissues [deep
third degree] with loss of a body part, of
hand, unspecified site.
945.00................... Burn of unspecified degree of lower limb
[leg], unspecified site.
945.01................... Burn of unspecified degree of toe(s) (nail).
945.02................... Burn of unspecified degree of foot.
945.03................... Burn of unspecified degree of ankle.
945.04................... Burn of unspecified degree of lower leg.
945.05................... Burn of unspecified degree of knee.
945.06................... Burn of unspecified degree of thigh [any
part].
945.09................... Burn of unspecified degree of multiple sites
of lower limb(s).
945.20................... Blisters, epidermal loss [second degree] of
lower limb [leg], unspecified site.
945.40................... Deep necrosis of underlying tissues [deep
third degree] without mention of loss of a
body part, lower limb [leg], unspecified
site.
945.50................... Deep necrosis of underlying tissues [deep
third degree] with loss of a body part, of
lower limb [leg], unspecified site.
949.4.................... Deep necrosis of underlying tissue [deep
third degree] without mention of loss of a
body part, unspecified.
949.5.................... Deep necrosis of underlying tissues [deep
third degree] with loss of a body part,
unspecified.
997.60................... Unspecified complication of amputation stump.
------------------------------------------------------------------------
IX. Non-Quality Related Revisions to IRF-PAI Sections
Under section 1886(j)(2)(D) of the Act, the Secretary is authorized
to require rehabilitation facilities that provide inpatient hospital
services to submit such data as the Secretary deems necessary to
establish and administer the prospective payment system under
subsection P. The collection of patient data is indispensable for the
successful development and implementation of the IRF payment system. In
the August 7, 2001 final rule, the inpatient rehabilitation facility
patient assessment instrument (IRF-PAI) was adopted as the standardized
patient assessment instrument under the IRF prospective payment system
(PPS). The IRF-PAI was established, and is still used to gather data to
classify patients for payment under the IRF PPS. As discussed in
section XIV of this final rule, it is also now used to collect certain
data for the IRF Quality Reporting Program. IRFs are currently required
to complete an IRF-PAI for every Medicare Part A or C patient who is
admitted to, or discharged from an IRF. (We note that Medicare Part B
was inappropriately listed in the proposed rule. We are clarifying that
IRFs are not required to submit the IRF-PAI for Medicare Part B
patients.)
Although there have been significant advancements in the industry,
no IRF PPS payment-related changes have been made to the IRF-PAI form
since its implementation in FY 2002. In the FY 2014 IRF PPS proposed
rule, we proposed amending certain response code options, adding
additional data points, removing certain outdated items and changing
certain references to ensure that our policies reflect the current data
needs of the IRF PPS program.
A. Revisions
We proposed to amend the response codes on the following items in
the IRF-PAI:
Item 15A: Admit From (Formerly item 15)
Item 16A: Pre-Hospital Living Situation (Formerly item 16)
Item 44D: Patient's Discharge Destination/Living Setting
(Formerly item 44A)
To minimize possible confusion due to the use of different sets of
status codes on the IRF-PAI and the CMS-1450 (also referred to as the
UB-04) claim form, we believe that the IRF-PAI status codes should be
updated to mirror those used on the UB-04 claim form. We also believed
this update would help with consistency, ultimately decreasing the rate
of coding submission errors on the UB-04 claim form. We believed that
would provide response options that mirror other commonly used
instruments in the Medicare context allowing providers to use only one
common set of response codes. We proposed to amend the response options
for the three items listed above to:
01--Home (private home/apt., board/care, assisted living,
group home)
02--Short-term General Hospital
03--Skilled Nursing Facility (SNF)
50--Hospice
62--Another Inpatient Rehabilitation Facility
63--Long-Term Care Hospital (LTCH)
64--Medicaid Nursing Facility
65--Inpatient Psychiatric Facility
66--Critical Access Hospital
99--Not Listed
We also proposed to update the options for responding to item 20B:
Secondary Source. While not expressly stated in the preamble, but
evident from
[[Page 47896]]
the web-posted draft of the IRF-PAI that was cross-referenced in the
proposed rule, we also proposed to amend the response codes for 20A:
Primary Source as well. As we noted in the proposed rule, we find that
the current response options for these data elements result in the
collection of patient information that we do not currently need to
operate the IRF PPS and the IRF quality programs. Therefore, we limit
our data collections to those which are currently needed, and in an
effort to decrease burden on IRFs through the implementation of
simplified response options, we proposed to limit the secondary source
response options to the following:
02--Medicare--Fee for Service
51--Medicare--Medicare Advantage
99--Not Listed
B. Additions
Further, we proposed to add (or expand) the following items to the
IRF-PAI:
Item 25A: Height
Item 26A: Weight
Item 24: Comorbid Conditions (15 additional spaces)
Item 44C: Was the patient discharged alive?
Signature of Persons Completing the IRF-PAI
Items 25A: Height and 26A: Weight, are important items to collect
for using in the classification of facilities for payment under the
IRF-PPS as well as for the risk adjustment of quality measures (as
described in section XIV of this final rule). In the regulations at
section 412.29(b)(2), we specify a list of comorbid conditions that, if
certain conditions are met, may qualify a patient for inclusion in an
IRF's 60 percent rule compliance percentage. For example, a patient
with a lower-extremity joint replacement comorbidity could qualify as
an IRF patient under the 60 percent rule compliance percentage if they
have one or more of the following:
A bilateral joint replacement
Is over the age of 85
Has a BMI greater than 50.
The patient's BMI is calculated using height and weight. By adding a
patient's height and weight information to the IRF-PAI, we will for the
first time have enough information on the number and types of patients
being treated for a lower-extremity joint replacement with a BMI
greater than 50 for purposes of analyzing the effects of the 60 percent
rule.
We also proposed to add 15 additional spaces for providers to
document patients' comorbid medical conditions at item 24: Comorbid
Conditions (located in the medical information section of the IRF-PAI).
The IRF-PAI currently has ten spaces available for providers to enter
ICD codes for comorbid conditions. Including the 15 additional proposed
spaces for this item will give providers a total of 25 spaces on the
IRF-PAI. Such expansion will enable IRFs to code with greater
specificity which may result in accounting for additional
comorbidities. Further identification of patient characteristics may
assist in care planning, payment assignment, and presumptive compliance
method compliance calculations. Furthermore, in order to stay aligned,
we believe that the number of data elements allowed on the IRF-PAI for
item 24: Comorbid Conditions, should mirror the number of spaces
currently available for providers to document patients' comorbidities
on the UB-04 claim. Additionally, the ICD-10 coding scheme will become
effective on October 1, 2014, and is much more specific than the
current ICD-9 coding. Therefore, when the agency moves from ICD-9 to
ICD-10 coding, providers may need the additional spaces to code because
of the greater specificity under ICD-10.
Furthermore, we proposed to add a new item 44C: ``Was the patient
discharged alive?'' to the discharge information section on the IRF-
PAI. Adding this item as a standalone item would allow facilities that
reply ``no'' to 44C to skip items 44D, 44E, and 45, which describe a
living patient's discharge destination. This will also reduce the
burden on the time it takes providers to complete the IRF-PAI.
Facilities that respond ``yes'' to item 44C will complete items 44D,
44E and 45 as they apply to the patient. We believe that adding this
question as a standalone item would provide greater clarity for
providers when documenting patient information on the IRF-PAI.
We also proposed to add a page to the IRF-PAI dedicated as the
signature page for persons completing the IRF-PAI. As of the effective
date of the IRF Coverage Requirements (see the August 7, 2009 FY 2010
IRF PPS final rule (74 FR 39762)) a patient's IRF-PAI must be
maintained in their medical record at the IRF (electronic or paper
format), and the information in the IRF-PAI must correspond with all of
the information provided in the patient's IRF medical record. We
received multiple public comments on the FY 2010 IRF PPS proposed rule
regarding the requirement to include the IRF-PAI in the medical record.
Commenters questioned whether IRFs would need to adhere to the
conditions of participation in Sec. 482.24(c)(1) that require all
patient medical record entries must be legible, complete, dated, timed,
and authenticated in written or electronic form by the person
responsible for providing or evaluating the service provided,
consistent with hospital policies and procedures. When we responded (at
https://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/IRF-Training-call_version_1.pdf) that
IRFs would need to adhere to Sec. 482.24(c)(1), providers responded by
asking for a place on the IRF-PAI where they would be able to document
the required authentication. The addition of a signature page for
persons completing the IRF-PAI would fulfill providers' request to have
an organized way to document who in the IRF has completed an IRF-PAI
item and/or section when the information was completed. We also believe
that the addition of a signature page for those completing the IRF-PAI
will ensure that providers are satisfying both the IRF coverage
requirements and the conditions of participation requirements.
C. Deletions
We proposed to delete the following items from the IRF-PAI:
Item 18: Pre-Hospital Vocational Category
Item 19: Pre-Hospital Vocational Effort
Item 25: Is patient comatose at admission?
Item 26: Is patient delirious at admission?
Item 28: Clinical signs of dehydration
Because we no longer believe that these items are necessary and in
the interest of reducing burden on providers, we would like to delete
them.
Items 18: Pre-Hospital Vocational Category and 19: Pre-Hospital
Vocational Effort (currently located in the admission identification
section on the IRF-PAI) are not used for payment or quality purposes.
While these items will be removed from the IRF-PAI, we note that these
data elements could be significant in a treatment context. For example,
we believe that these data elements could be relevant during the care
planning/discharge process, as well as during interdisciplinary team
meetings. Therefore, we would expect them to appear in the patient's
medical record.
We also note, that items 25: Is patient comatose at admission, 26:
Is patient delirious at admission, and 28: Clinical signs of
dehydration (currently located in the medical information section on
the IRF-PAI) are voluntary items that
[[Page 47897]]
are not used for our payment or quality program purposes. Therefore, we
do not believe it is necessary to collect this information on the IRF-
PAI. Furthermore, to the extent such information would be relevant to
the provision of patient care; this information should be captured in
either the transfer documentation from the referring physician, or the
patients' initial assessment documentation. As such, continuing to
require this information on the IRF-PAI would be duplicative since the
items should be well documented in the patients' medical record from
their stay at the facility.
D. Changes
We proposed to replace all references to the ICD-9-CM code(s) in
the IRF-PAI with references to ICD code(s). This change would allow CMS
to forgo making additional changes to the IRF-PAI when the adopted ICD
code(s) change.
Proposed Technical Correction
We proposed technical corrections at items 44D, 44E and 45 to
conform to the additions above. We believe that adding language to
these items indicating that the question can be skipped depending upon
how item 44C is answered, will help reduce submission errors for
providers when filling out the IRF-PAI.
A draft of the IRF-PAI, with the revisions proposed in the proposed
rule was made available for download on the IRF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRFPAI.html.
We received 18 comments on the proposed changes to the non-quality
related revisions to IRF-PAI sections, which are summarized below.
Comment: Overall, the majority of commenters commended CMS for
assessing the non-quality related portions of the IRF-PAI for
refinements.
Response: We appreciate the support from the commenters regarding
the changes to the IRF-PAI. We believe that the IRF-PAI changes will
promote efficiency and clarity for providers as well as ensure that our
policies reflect the current data needs required to support the IRF PPS
program.
Comment: Many of the commenters supported our proposal to align the
status codes on the IRF-PAI with those used on the UB-04 claim form.
Commenters agreed that the proposed changes would help providers avoid
coding errors. More specifically, two commenters commended our proposed
removal of the status code 13 (sub-acute care) stating that the term is
not clearly defined and is more commonly used as a marketing term.
Response: We appreciate the support from commenters regarding the
proposed changes to the IRF-PAI. We believe that streamlining claim
submission codes and IRF-PAI status codes will ease the administrative
burden for providers as well as reduce coding errors.
Comment: One commenter suggested that we should delete item 44E:
Was patient discharged with Home Health Services, and instead add code
06-Home under care of organized home health service organization, to
item 44D: Patient's discharge destination/living setting. Likewise,
another commenter recommended that we remove the proposed new item 44C:
Was the patient discharged alive and add the status code option 20-
Expired. Additionally, another commenter supported our proposal to add
50-Hospice as a status code option, however, suggested that CMS should
add the status code option 51-Hospice (Institutional Facility). The
commenters suggested that these status code options would more
accurately reflect the UB-04 claim form.
Response: As we mentioned in the proposed rule, many of the changes
we made on the non-quality related IRF-PAI items were to initiate
standardization between IRF claims and the IRF-PAI when coding
patients. Our intent in mirroring the IRF-PAI status codes with the UB-
04 claim form codes was to help providers avoid future coding errors.
After reviewing the comments submitted, we agree with most of the
commenters suggestions to add several status code options to further
mirror the UB-04 claim form. In addition to finalizing the proposed
status code changes, we will also add the following status code
options, which are identical to the options on the UB-04 claim form to
items 15A: Admit From; 16A: Pre-hospital Living Setting; and 44D:
Patient's discharge destination/living setting:
04--Intermediate Care Facility
06--Home under care of organized home health service organization
51--Hospice (Institutional Facility)
61--Within institution to swing bed
We do not agree with the commenters suggestion to remove item 44C: Was
the patient discharged alive, and add 20-Expired as a status code
option. Although the status code would mirror the UB-04 claim form, we
do not believe ``expired'' is an adequate response when providers are
answering a question regarding the patient's discharge destination. If
a patient expires while in the IRF, they are not discharged from the
facility therefore, we would still need item 44C: Was the patient
discharged alive. Additionally, adding this item as a standalone item
allows clear delineation of a section of the IRF-PAI that providers
would not have to report if the reply to 44C is ``no''. Items 44D and
45, which describe a living patient's discharge destination, can then
be skipped. Finally, in light of the addition of status code option
06--Home under care of organized home health service organization; we
will remove item 44E: Was patient discharged with Home Health Services
live, as this item would be redundant for providers to answer.
Comment: One commenter suggested that we should consider creating a
new status code option 08-subacute (SNF with continued therapy plan of
care/skilled needs).
Response: We appreciate the commenter's suggestion and will
consider creating a new status code option 08-Subacute (SNF with
continued therapy plan of care/skilled needs) during future rulemaking.
However, our intentions of changing the status code options on the IRF-
PAI were to mirror those on the UB-04 claim form, and this suggestion
does not conform to those changes as it is not currently necessary for
IRF payment or quality reporting.
Comment: Several commenters expressed concern that the coding
changes to the IRF-PAI for items 15A: Admitted From; 16A: Pre-Hospital
Living Situation; and 44D: Patient's Discharge Destination, are not
optimal and suggested that we retain the current IRF-PAI coding options
for these items. The commenters stated that the data collected by IRFs
in response to these items provide valuable information for quality
review and operational management. Limiting the response options too
severely, the commenters indicated, would impair an IRF's ability to
collect and retain valuable information for payers other than Medicare.
Response: We appreciate the commenters suggestion as we continue to
believe that the status code changes are necessary to provide better
clarity and alignment with the UB-04 claim form, ultimately reducing
coding submission errors. Although we have removed some status code
options, we do not believe that we are preventing or deterring IRFs
from continuing to collect patient information and document it within
the medical record.
Comment: One commenter disagreed with our proposal to group the
existing status codes for private home, board/care, assisted living and
group home
[[Page 47898]]
together under the proposed status code 01--Home (private home/apt.,
board/care, assisted living, group home) and to completely remove the
code options for transitional living and intermediate care from items
15A: Admitted From; 16A: Pre-Hospital Living Situation; and 44D:
Patient's Discharge Destination. The commenter recommended that if the
proposed status code changes are finalized, we should consider adding
transitional living and intermediate care under the status code 01--
Home.
Response: As we have previously mentioned, our goal in proposing to
change some of the status code options on the IRF-PAI is to be as
consistent as possible with the UB-04 claim form. Therefore, we
disagree with the commenters' suggestion to ungroup the existing status
codes for private home, board/care, assisted living, and group home
under the proposed status code 01--Home. But we do agree with the
commenter that intermediate care and transitional living are status
code options that should be included in the IRF-PAI. Therefore, we will
add status code 04--Intermediate care. Furthermore, we will include
transitional living as one of the locations listed in status code 01--
Home to the response options.
Comment: Several commenters expressed concerns with our proposed
change to limit the status code options in item 22B: Secondary Source,
to only 02--Medicare-Fee For Service; 51 Medicare-Medicare Advantage;
and 99 Not Listed, stating that IRFs would lose the ability to track
other payer sources beyond Medicare. One commenter suggested that if we
remove the majority of the code options in item 20B: Secondary Source,
then we should display the current comprehensive list of payment
sources under item 20A: Primary Source. Additionally, the commenter
recommended that we add Medicaid Expansion and the Health Insurance
Marketplace as status code options. Another commenter stated that
decreasing the number of code options will not really save time and
burden for providers.
Response: We respectfully disagree with the commenters and continue
to believe that decreasing the number of code options will allow
providers to code more accurately and reduce burden. However, even if
this is not the case, we do not have authority to collect the various
information requests the commenters suggested since the information is
not currently relevant for administration of the IRF PPS or for the IRF
Quality Reporting Program. According to the Privacy Act at 5 U.S.C.
552a(e)(1), an ``agency that maintains a system of records shall--(1)
maintain in its records only such information about an individual as is
relevant and necessary to accomplish a purpose of the agency required
to be accomplished by statute or executive order of the President.''
When an IRF uploads the IRF-PAI data, it is entered into CMS's Privacy
Act System of Records. As the status code options removed from the
secondary source item are currently irrelevant to both the IRF payment
system and the IRF Quality Reporting Program, we do not have statutory
authority to continue to collect this information. Furthermore, we do
not believe that we are limiting IRFs from continuing to collect and
document payer source information by way of their own internal
mechanisms. Furthermore, as we previously mentioned, it was our intent
to include item 20A: Primary Source regarding this update, as the list
of status code options identified in the Payer Information section
relates to both items 20A and 20B. Additionally, the draft version of
the IRF-PAI that went on display with the proposed rule very clearly
depicts the changes; therefore, we will finalize our proposals as they
were described in the proposed rule and the draft IRF-PAI
Comment: The majority of commenters supported the additional 15
extra spaces in item 24: Comorbid Conditions, and the new items 25A:
Height and 26A Weight. One commenter suggested that items 25A and 26A
would be more beneficial if time parameters such as ``admission'' or
``discharge'' were placed on the measure. One commenter suggested that
adding items 25A: Height; 26A Weight; and 27: Swallowing Status, to the
IRF-PAI would be redundant, as this information is already in the
patient's medical record. This commenter also requested clarification
as to whether these items would be mandatory or optional requirements
on the IRF-PAI.
Response: We appreciate the support from the commenters regarding
the proposed addition of the 15 extra spaces in item 24: Comorbid
Conditions, and the new items 25A: Height and 26A Weight. We believe
these items are pertinent information to add to the IRF-PAI and allow
additional information to be collected after the transition to the more
specific ICD-10-CM codes. We note that the proposed items 25A: Height
and 26A: Weight already indicate ``on admission'' as a time parameter.
Additionally, items 25A: Height and 26A: Weight will be mandatory items
on the IRF-PAI, as these items are needed for payment and quality
measurement purposes. CMS did not propose any changes to item 27:
Swallowing Status, therefore, it will remain a voluntary item.
We disagree with the commenter's statement that items 25A and 26A
are redundant, as all of the information on the IRF-PAI must also be
included in some form in the medical record. We require this
information on the IRF-PAI so that it may be submitted to us to enable
the implementation of the IRF PPS and the IRF quality reporting
program. Therefore, we are finalizing both of these items as they were
proposed.
Comment: The majority of commenters supported the addition of a
signature page to the IRF-PAI. A few commenters suggested that we allow
an electronic signature to satisfy this new requirement. One commenter
suggested that we add a prompt on the signature page for ``time'' in
order to comply with the requirements at 482.24(c)(1).
Response: We appreciate the commenters' suggestions regarding the
proposed signature page in the IRF-PAI. In order to stay consistent
with our current procedures, providers should reference the
clarification to our coverage requirements regarding the use of
electronic signatures located at (https://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/ElecSysClar.pdf).
Should a formal policy be established for the development of
Medicare's formal electronic signature policies, we may need to revise
or further clarify these criteria to ensure that it is in accordance
with those policies.
Additionally, we agree with the commenters' suggestion that a
``time'' prompt should be added to the signature page. Therefore, we
will add an additional column for providers to indicate the time that
they completed an item and/or section of the IRF-PAI.
Comment: A few commenters requested that we clarify and/or provide
more specific instructions for completing the proposed signature page
in the IRF-PAI. One commenter was unclear as to why multiple signatures
are required, as the information on the IRF-PAI is documented and
authenticated within the medical record documentation. Another
commenter requested clarification regarding the use of the word
``submit'' when referring to the sentence, ``I also certify that I am
authorized to submit this information by this facility on its behalf.''
The commenter acknowledged that anyone who contributes to the IRF-PAI
is, in effect, involved in the submitting of data to us. However, in
common parlance, ``submit'' often refers to the actual act of
electronically submitting the final product to us.
[[Page 47899]]
Response: We plan to provide more specific instructions for
completing the signature page in the IRF-PAI training manual that will
accompany the revised IRF-PAI form. We understand the commenter's
concerns regarding the attestation statement on the signature page, and
we are deleting the statement, ``I also certify that I am authorized to
submit this information by this facility on its behalf.'' Removal of
this statement from the attestation should clarify what providers are
attesting to, and alleviate any concerns.
Comment: Several commenters expressed concern that the proposed
addition of the signature page is burdensome and unnecessary because
staff entries in the electronic health record are already stamped with
date and time, in addition to the name and credentials of the person
entering the information. These commenters stated that it would be
burdensome to track down individuals to sign an additional sheet of
paper.
Response: When the coverage requirements became effective January
1, 2010, providers requested a place on the IRF-PAI where they could
sign, date, and record the time in order to comply with the hospital
conditions of participation (CoPs). We are taking this opportunity to
acknowledge those requests made by the industry. Additionally, the
signature item clarifies for the provider and CMS that the requirement
has been met.
Comment: One commenter requested that we provide a definition for
the new discharge status code 64--Medicaid Nursing Facility.
Response: Medicaid coverage of nursing facility services is
available only for services provided in a nursing home licensed and
certified by the state survey agency as a Medicaid Nursing Facility
(NF). Medicaid nursing facility services are available only when other
payment options are unavailable and the individual is eligible for the
Medicaid program. For more information please reference the link
provided: https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Delivery-Systems/Institutional-Care/Nursing-Facilities-NF.html.
Comment: One commenter recommended that the IRF-PAI changes be
delayed one year to coincide with the implementation of ICD-10, so that
providers can incorporate all of the changes at one time. This
commenter suggested that a delayed effective date for the IRF-PAI
changes would decrease burden by only having to make updates to
information systems once.
Response: We proposed an effective date of October 1, 2014, for all
of the finalized IRF-PAI changes. In concert with stakeholder
recommendations, we are finalizing this proposal which will help
alleviate burden on providers. We believe that the October 1, 2014
effective date will provide IRF's with an adequate amount of time to
make necessary changes to information systems as well as provide
extensive education for clinicians.
Final Decision: Based on careful consideration of the comments that
we received on the proposed non-quality related updates to the IRF-PAI
for FY 2014, we are finalizing the following items:
The status code options for Items 15A: Admit From, 16A:
Pre-hospital Living Situation and 44D: Patient's Discharge Destination/
Living Setting will be 01--Home (private home/apt., board/care,
assisted living, group home, transitional living); 02--Short-term
General Hospital; 03--Skilled Nursing Facility (SNF); 04--Intermediate
Care; 06--Home under care of organized home health service
organization; 50--Hospice (Home); 51--Hospice (Institutional Facility);
61--Within institution to swing bed; 62--Another Inpatient
Rehabilitation Facility; 63--Long-Term Care Hospital (LTCH); 64--
Medicaid Nursing Facility; 65--Inpatient Psychiatric Facility; 66--
Critical Access Hospital; 99--Not Listed
The status code options for Items 20A: Primary Source and
20B: Secondary Source will be 02--Medicare-Fee for Service; 51--
Medicare-Medicare Advantage; 99--Not Listed
The additions will include Item 24: Comorbid Conditions
(15 additional spaces); item 25A: Height; item 26A: Weight; Signature
of Persons Completing the IRF-PAI (with the addition of a ``time''
prompt); 44C: Was the patient discharged alive?
The deletions will include items 18: Pre-Hospital
Vocational Category; 19: Pre-Hospital Vocational Effort; 25: Is the
patient comatose at admission; 26: Is the patient delirious at
admission; 28: Clinical signs of dehydration; 44E: Was patient
discharged with Home Health Services
Using the language ICD code(s) on the IRF-PAI
The technical corrections at items 44D: Patient's
discharge destination/living setting and 45: Discharge to Living With
The revised IRF-PAI will become effective for IRF
discharges occurring on or after October 1, 2014. All final changes to
the IRF-PAI will be represented when it is posted with the final rule.
X. Technical Corrections to the Regulations at Sec. 412.130
In the FY 2012 IRF PPS final rule (76 FR 47869 through 47873), we
revised the regulations for inpatient rehabilitation facilities at
Sec. 412.23(b), Sec. 412.25(b), Sec. 412.29, and Sec. 412.30 to
update and simplify the policies, to eliminate unnecessary repetition
and confusion, and to enhance consistency with the IRF coverage
requirements. Among other revisions, we removed the regulations that
were formerly in Sec. 412.30, and revised and consolidated the
requirements regarding ``new'' IRFs and ``new'' IRF beds that
previously existed in Sec. 412.30 into the revised regulations at
Sec. 412.29(c). However, we have recently discovered that Sec.
412.130, which outlines the policies regarding retroactive adjustments
for incorrectly excluded hospitals and units, was not updated to
reflect the changes to Sec. 412.30 and Sec. 412.29. Specifically,
Sec. 412.130 still references regulations in Sec. 412.30 that were
revised and consolidated into Sec. 412.29(c). Further, it still
references regulations that were formerly in Sec. 412.23(b)(2), but
were moved into Sec. 412.29(b) in the FY 2012 IRF PPS final rule (76
FR 47869 through 47873).
We proposed to make the following technical corrections to the
regulations in Sec. 412.130 to conform with the revisions to the
regulations in Sec. 412.23(b), Sec. 412.29, and Sec. 412.30 that
were implemented in the FY 2012 IRF PPS final rule (76 FR 47869 through
47873):
Replace the current reference to ``Sec. 412.23(b)(8)'' in
Sec. 412.130(a)(1) with the new reference to Sec. 412.29(c),
Replace all of the current references to ``Sec.
412.23(b)(2)'' in Sec. 412.130(a)(1), (2), and (3) with the new
reference to Sec. 412.29(b),
Replace the current reference to ``Sec. 412.30(a)'' in
Sec. 412.130(a)(2) with the new reference to Sec. 412.29(c), and
Replace the current reference to ``Sec. 412.30(c)'' in
Sec. 412.130(a)(3) with the new reference to Sec. 412.29(c).
We did not receive any comments on the proposed technical
corrections to the regulations at Sec. 412.130. Thus, we are
finalizing the technical corrections as proposed, effective for IRF
discharges occurring on or after October 1, 2013.
XI. Revisions to the Conditions of Payment for IRF Units Under the IRF
PPS
The regulations at Sec. 412.25 specify the requirements for an IRF
unit to be excluded from the inpatient prospective
[[Page 47900]]
payment system (IPPS) specified in Sec. 412.1(a)(1) and to instead be
paid under the IRF PPS specified in Sec. 412.1(a)(3). The requirements
at Sec. 412.25 are unique to IRF units of hospitals, whereas the
requirements at Sec. 412.29 apply to both freestanding IRF hospitals
and IRF units of hospitals. Among the requirements at Sec. 412.25 is
the requirement (at Sec. 412.25(a)(1)(iii)) that the institution of
which the IRF unit is a part must have ``enough beds that are not
excluded from the prospective payment systems to permit the provision
of adequate cost information, as required by Sec. 413.24(c) of this
chapter.'' We have not previously specified how many such beds the
hospital, of which the IRF unit is a part, must have to meet this
requirement. However, we have recently received questions from
providers about whether one or two hospital beds that are certified for
payment under the IPPS, in some cases beds that are rarely used for
patient care, would meet the requirement at Sec. 412.25(a)(1)(iii). We
believe this does not meet the requirement at Sec. 412.25(a)(1)(iii),
which provides for the hospital of which the IRF unit is a part to be
an IPPS hospital, which we believe is not demonstrated by the presence
of just one or two hospital beds.
In addition, from a fairness and quality of care perspective, we
are particularly concerned about the application of the regulations in
Sec. 412.29(g), which require freestanding IRF hospitals to have a
full-time director of rehabilitation, but only require IRF units of
acute care hospitals (and CAHs) to have a director of rehabilitation
for 20 hours per week. We believe that it is unfair to other
freestanding IRF hospitals and potentially problematic from a quality
of care standpoint for an IRF that is effectively operating as a
freestanding IRF hospital, even though it is technically classified as
an IRF unit, to be allowed to have a director of rehabilitation only 20
hours per week.
Further, we are unclear how the IRF unit that is part of a hospital
with only one or two beds would be able to meet another requirement, at
Sec. 412.25(a)(7), that specifies that an IRF unit must have beds that
are ``physically separate from (that is, not commingled with) the
hospital's other beds.'' The requirement at Sec. 412.25(a)(7) means
that there is some sort of physical separation that distinguishes the
IRF unit from the rest of the hospital beds. We believe that it is
unlikely that this requirement would be met in the situation in which
the hospital of which the IRF unit is a part only has one or two beds,
in some cases beds that are rarely used for patient care.
Thus, we proposed to specify at Sec. 412.25(a)(1)(iii) a minimum
number of hospital beds that the IPPS hospital must have to meet the
requirements at Sec. 412.25(a)(1)(iii) for having an IRF unit. We note
that, thoughSec. 412.25(a)(1)(iii) also applies to inpatient
psychiatric facilities (IPFs), these facilities have their own
requirements at Sec. 412.27 for payment under the IPF PPS that we are
not changing in this proposed rule. IPFs should continue following the
regulations at Sec. 412.27.
We proposed to specify in Sec. 412.25(a)(1)(iii) that the
institution of which the IRF unit is a part must have at least 10
staffed and maintained hospital beds that are not excluded from the
IPPS, or at least 1 staffed and maintained hospital bed for every 10
certified IRF beds, whichever number is greater. If the institution is
not able to meet this requirement, then the IRF unit should instead be
classified as an IRF hospital. We also proposed to exclude CAHs that
have IRF units from these requirements, as CAHs already have very
specific bed size restrictions.
We received 3 comments on the proposed revisions to the conditions
of payment for IRF units under the IRF PPS, which are summarized below.
Comment: Several commenters noted that the conversion from an IRF
unit to a freestanding IRF hospital to meet the new proposed
requirements could pose problems for a facility in meeting certain
state licensing and/or state certificate of need requirements. These
commenters suggested that these state-level requirements could be
``burdensome, difficult and expensive'' for the IRF.
Response: Although the conversion from an IRF unit to a
freestanding IRF hospital is a simple administrative task within
Medicare, which does not necessitate any new surveys, any changes to
the IRF's Medicare provider agreement, or any changes to the IRF's
payment status under Medicare, we recognize that the conversion may
take longer to complete under state laws. Thus, we are implementing
this change on a one-year delay, so that it will be effective for IRF
discharges occurring on or after October 1, 2014, to give IRFs who are
affected by this change ample time to conform to state certificate of
need or other state licensure laws.
Final Decision: After considering the comments that we received on
the proposed revision to the conditions of payment for IRF units under
the IRF PPS, we are finalizing the change to Sec. 412.25(a)(1)(iii) to
specify that the institution of which the IRF unit is a part must have
at least 10 staffed and maintained hospital beds that are not excluded
from the IPPS, or at least 1 staffed and maintained hospital bed for
every 10 certified IRF beds, whichever number is greater. We exclude
CAHs that have IRF units from these requirements, as CAHs already have
very specific bed size restrictions. We are implementing this change
effective for IRF discharges occurring on or after October 1, 2014 (a
one-year delay in the effective date) to give IRFs affected by this
change adequate time to comply with state certificate of need or other
state licensure laws.
XII. Clarification of the Regulations at Sec. 412.630
In the original rule establishing a prospective payment system for
Medicare payment of inpatient hospital services provided by a
rehabilitation hospital or by a rehabilitation unit of a hospital, we
stated that that there would be no administrative or judicial review,
under sections 1869 and 1878 of the Act or otherwise, of the
establishment of case-mix groups, the methodology for the
classification of patients within these groups, the weighting factors,
the prospective payment rates, outlier and special payments and area
wage adjustments. See FY 2002 IRF PPS final rule (66 FR 41316, 41319).
Our intent was to honor the full breadth of the preclusion of
administrative or judicial review provided by section 1886(j)(8) of the
Act. However, the regulatory text reflecting the preclusion of review
has been at times improperly interpreted to allow review of adjustments
authorized under section 1886(j)(3)(v) of the Act. Because we interpret
the preclusion of review at Sec. 1886(j)(8) of the Act to apply to all
payments authorized under section 1886(j)(3) of the Act, we do not
believe that there should be administrative or judicial review of any
part of the prospective rate. Accordingly, we are clarifying our
regulation at Sec. 412.630 by deleting the word ``unadjusted'' so that
the regulation will clearly preclude review of ``the Federal per
discharge payment rates.'' This clarification will provide for better
conformity between the regulation and the statutory language.
As such, in accordance with sections 1886(j)(7)(A), (B), and (C) of
the Act, we are revising the regulations at Sec. 412.630 to clarify
that administrative or judicial review under sections 1869 or 1878 of
the Act, or otherwise, is prohibited with regard to the establishment
of the methodology to classify a patient into the case-mix groups and
the associated weighting factors, the federal per discharge payment
rates, additional
[[Page 47901]]
payments for outliers and special payments, and the area wage index.
We received 2 comments on the proposed clarification of the
regulations at Sec. 412.630, which are summarized below.
Comment: The commenters expressed concerns with our proposal to
revise the regulations at 42 CFR 412.630 to clarify that the Medicare
statute precludes administrative and judicial review of the Federal per
discharge payment rates, including the LIP adjustment. One commenter
stated that the proposal is not a ``clarification'' that can be applied
to pending cases, is inconsistent with the statute, runs afoul of the
presumption of judicial review, fails to give proper notice of the
regulatory change, and is unconstitutional.
Response: We disagree with the commenter's statements. Our proposed
change serves to clarify the regulation so that it clearly reflects the
preclusion of review found in the statute. It also removes any doubt as
to the conformity of the regulation to the preclusion of review found
in the statute, which by its own terms is applicable to all pending
cases regardless of whether it is reflected in regulations or not.
We also strongly disagree with the commenter's reading of the
statute. Section 1886(j)(8) of the statute broadly precludes review of
``the prospective payment rates under paragraph (3),'' that is, section
1886(j)(3). Within this section, subsection 1886(j)(3)(A) authorizes
certain adjustments to the IRF payment rates and, within that,
subsection 1886(j)(3)(A)(v) authorizes adjustments to the rates by such
other factors as the Secretary determines are necessary to properly
reflect variations in necessary costs of treatment among rehabilitation
facilities.'' The LIP adjustment is made under authority of section
1886(j)(3)(A)(v). As that provision is contained within section
1886(j)(3), and the IRF payment rates under section 1886(j)(3) are
precluded from review by section 1886(j)(8), the LIP adjustment falls
squarely within the statutory preclusion of review. Such preclusion
overcomes any presumption of reviewability that might generally apply,
and it is not unconstitutional for Congress (which has the power to
define the jurisdiction of the federal courts) to preclude review of
certain issues as it has done here. Several virtually identical
preclusions of review in other sections of the Medicare statute have
been repeatedly upheld and applied by federal courts. Finally, as to
notice, the proposed rule itself served as notice of our intention to
revise the regulation. In addition, as discussed below, the
longstanding language of the statute itself provides sufficient notice
to apply the preclusion.
Comment: One commenter stated that our proposal cannot be a
clarification because we have allowed review of matters concerning the
LIP adjustment for many years. This commenter further stated that any
preclusion of review should apply only to the ``formulas'' used in the
IRF payment rates, and that to preclude review would prevent providers
from correcting errors in their payments and would result in two
separate methods being used to pay IRFs and hospitals paid under the
inpatient prospective payment system (IPPS).
Response: We disagree with these comments. The preclusion of review
has been effective since its enactment as part of the IRF prospective
payment system in 2002. No regulation or revision of any regulation was
necessary for the statutory preclusion to become effective, regardless
of whether we or our contractors may have participated in review of IRF
LIP matters in the past without making a jurisdictional objection. To
the extent that such erroneous participation may have occurred, it does
not override the mandate of the statute or prevent us from immediately
applying the statutory preclusion of review.
In addition, the preclusion applies to all aspects of the IRF PPS
payment rates, not just the formulas. Courts have applied nearly
identical preclusion provisions in other parts of the Medicare statute
to prevent review of all subsidiary aspects of the matter or
determination protected from review. Finally, while precluding review
of the IRF LIP adjustment may prevent correction of certain errors, we
can only conclude that Congress has made the judgment that such a
result is an appropriate trade-off for the gains in efficiency and
finality that are achieved by precluding review. Similarly, although
applying the preclusion here may result in certain questions being
reviewable for an IPPS hospital but not an IRF, this is a judgment that
Congress has made. We note that there is a preclusion of review
provision in the IPPS statute also, at section 1886(d)(7). The precise
contours of these preclusive provisions were for Congress to draw.
Final Decision: After careful review of the comments we received on
the clarification of the regulations at Sec. 412.630, we are adopting
our proposal to revise the regulations at 42 CFR 412.630 to clarify
that the Medicare statute precludes administrative and judicial review
of the Federal per discharge payment rates under section 1886(j)(3),
including the LIP adjustment. This revision to the regulation is
effective October 1, 2013.
XIII. Revision to the Regulations at Sec. 412.29
According to the regulations at Sec. 412.29(d), to be excluded
from the inpatient prospective payment system (IPPS) and instead be
paid under the IRF PPS, a facility must ``have in effect a preadmission
screening procedure under which each prospective patient's condition
and medical history are reviewed to determine whether the patient is
likely to benefit significantly from an intensive inpatient hospital
program. This procedure must ensure that the preadmission screening is
reviewed and approved by a rehabilitation physician prior to the
patient's admission to the IRF.'' The latter sentence of this
regulation is based on the preadmission screening requirement for
Medicare coverage of IRF services in Sec. 412.622(a)(4)(i)(D). The
requirement was repeated in both places for consistency.
However, in Sec. 412.622(a)(4)(i)(D), we specify that this
requirement applies to patients ``for whom the IRF seeks payment'' from
Medicare. We believe that the analogous requirement in Sec. 412.29(d)
should also clearly state that it applies only to patients for whom the
IRF is seeking payment directly from Medicare. Other payer sources,
such as private insurance, have their own IRF admission requirements,
and we do not believe that it would be appropriate to interfere with or
duplicate the requirements that other payer sources may already have in
place. Thus, we proposed to amend Sec. 412.29(d) to clarify that the
IRF's preadmission screening procedure must ensure that the
preadmission screening for a Medicare Part A Fee-for-Service patient is
reviewed and approved by a rehabilitation physician prior to the
patient's admission to the IRF. We continue to believe that the basic
preadmission screening procedure itself is an important element of
providing quality IRF care to all patients and, thus, we will require
that the basic preadmission screening procedure requirement remain in
place for all patients regardless.
We received 5 comments on the revision to the regulations at Sec.
412.29(d), which are summarized below.
Comment: Several commenters expressed support for the proposed
revisions to the regulations at Sec. 412.29, which clarify that we
require rehabilitation physician review and concurrence of a patient's
preadmission screening prior to the IRF admission
[[Page 47902]]
only for Medicare Fee-for-Service beneficiaries. The commenters
indicated that this proposed regulation change would greatly relieve
the burden on IRFs that treat a large proportion of non-Medicare
patients, for whom other admission requirements typically apply. These
commenters also requested that we amend the Rehabilitation Unit and
Rehabilitation Hospital Criteria Worksheets and the Attestation
Statement (State Operations Manual Exhibit 127, Attestation Statement)
to appropriately reflect this change to the regulations.
Response: We appreciate the stakeholder community bringing this
issue to our attention, thereby giving us the opportunity to alleviate
unintended provider burden. We encourage stakeholders to bring these
types of issues to our attention, as we are always willing to consider
suggestions that can improve the Medicare program while at the same
time reducing the regulatory burden on providers. We will ensure that
the appropriate adjustments are made to the Worksheets and the
Attestation Statement in accordance with the change to the regulations.
Comment: One commenter recommended that we further clarify the
distinction between Medicare Conditions of Payment and the IRF coverage
requirements. The commenter suggested that a table distinguishing the
two requirements would be useful to providers.
Response: We thank the commenter for the suggestion, and will take
this into consideration for future stakeholder outreach in this area.
Final Decision: Based on consideration of the comments received on
the proposed change to Sec. 412.29(d), we are finalizing this change,
effective for IRF discharges occurring on or after October 1, 2013.
XIV. Revisions and Updates to the Quality Reporting Program for IRFs
A. Background and Statutory Authority
Section 3004(b) of the Affordable Care Act added section 1886(j)(7)
to the Act, which requires the Secretary to implement a quality
reporting program (QRP) for IRFs. This program applies to freestanding
IRF hospitals as well as IRF units that are affiliated with acute care
facilities, which includes critical access hospitals (CAHs).
Beginning in FY 2014, section 1886(j)(7)(A)(i) of the Act requires
the reduction of the applicable IRF PPS annual increase factor, as
previously modified under section 1886(j)(3)(D) of the Act, by 2
percentage points for any IRFs that fail to submit data to the
Secretary in accordance with requirements established by the Secretary
for that fiscal year. Section 1886(j)(7)(A)(ii) of the Act notes that
this reduction may result in the increase factor being less than 0.0
for a fiscal year, and in payment rates under this subsection for a
fiscal year being less than the payment rates for the preceding fiscal
year. Any reduction based on failure to comply with the reporting
requirements is, in accordance with section 1886(j)(7)(B) of the Act,
limited to the particular fiscal year involved. The reductions are not
to be cumulative and will not be taken into account in computing the
payment amount under section (j) for a subsequent fiscal year.
Section 1886(j)(7)(C) of the Act requires that each IRF submit data
to the Secretary on quality measures specified by the Secretary. The
required quality measure data must be submitted to the Secretary in a
form, manner and time, specified by the Secretary.
The Secretary is generally required to specify measures that have
been endorsed by the entity with a contract under section 1890(a) of
the Act. This contract is currently held by the National Quality Forum
(NQF), which is a voluntary consensus standard-setting organization.
The NQF was established to standardize health care quality measurement
and reporting through its consensus development process.
We have generally adopted NQF-endorsed measures in our reporting
programs. However, section 1886(j)(7)(D)(ii) of the Act provides that
``in the case of a specified area or medical topic determined
appropriate by the Secretary for which a feasible and practical measure
has not been endorsed by the entity with a contract under section
1890(a) of the Act, the Secretary may specify a measure that is not so
endorsed, so long as due consideration is given to measures that have
been endorsed or adopted by a consensus-based organization identified
by the Secretary.'' Under section 1886(j)(7)(D)(iii) of the Act, the
Secretary was required to publish the selected measures that will be
applicable to the FY 2014 IRF PPS no later than October 1, 2012.
Section 1886(j)(7)(E) of the Act requires the Secretary to
establish procedures for making data submitted under the IRF QRP
available to the public. The Secretary must ensure that each IRF is
given the opportunity to review the data that is to be made public
prior to the publication or posting of this data.
We seek to promote higher quality and more efficient health care
for all patients who receive care in acute and post-acute care
settings. Our efforts are, in part, effectuated by quality reporting
programs coupled with the public reporting of data collected under
those programs. The initial framework of the IRF QRP was established in
the FY 2012 IRF PPS final rule (76 FR 47873).
B. Quality Measures Previously Finalized for and Currently Used in the
IRF Quality Reporting Program
1. Measures Finalized in the FY 2012 IRF PPS Final Rule
In the FY 2012 IRF PPS final rule (76 FR 47874 through 47878), we
adopted applications of 2 quality measures for use in the first data
reporting cycle of the IRF QRP: (1) An application of ``Catheter-
Associated Urinary Tract Infection [CAUTI] for Intensive Care Unit
Patients'' \1\ (NQF0138); and (2) an application of ``Percent
of Residents with Pressure Ulcers that Are New or Worsened (short-
stay)'' (NQF 0678). We adopted applications of these 2
measures because neither of them, at the time, was endorsed by the NQF
for the IRF setting. We also discussed our plans to propose a 30-Day
All Cause Risk Standardized Post IRF Discharge Hospital Readmission
Measure at a later date.
---------------------------------------------------------------------------
\1\ The version of the CAUTI measure that was adopted in the FY
2012 IRF PPS final rule (76 FR 47874 through 47876) was titled
``Catheter-Associated Urinary Tract Infection [CAUTI] Rate Per 1,000
Urinary Catheter Days for ICU patients. However, shortly after the
FY 2012 IRF PPS final rule was published, this measure was submitted
by the CDC (measure steward) to the NQF for a measure maintenance
review, The CDC asked for changes to the measure, including
expansion of the scope of the measure to non-ICU patient care
locations and additional healthcare facility settings, including
IRFs. The name of the measure was changed to reflect the character
of the revised CAUTI measure. This measure is now titled ``National
Health Safety Network (NHSN) Catheter Associated Urinary Tract
Infection (CAUTI) Outcome Measure.''
---------------------------------------------------------------------------
2. Measures Finalized in the CY 2013 OPPS/ASC Final Rule
In the CY 2013 OPPS/ASC final rule (77 FR 68500 through 68507), we
adopted:
Updates to the CAUTI measure to reflect the NQF's
expansion of this measure to the IRF setting, replacing our previous
adoption of an application of the measure for the IRF QRP;
A policy that would allow any measure adopted for use in
the IRF QRP to remain in effect until the measure was actively removed,
suspended, or replaced (and specifically applied this policy to the
CAUTI and pressure ulcer measures that had already been adopted for use
in the IRF QRP); and
A sub-regulatory process to incorporate NQF updates to IRF
quality
[[Page 47903]]
measure specifications that do not substantively change the nature of
the measure.
At the time of the CY 2013 OPPS/ASC final rule, the NQF had
endorsed the pressure ulcer measure for the IRF setting, and re-titled
it to cover both residents and patients within LTCH and IRF settings,
in addition to the Nursing Home/Skilled Nursing Facility setting.
Although the measure had been expanded to the IRF setting, we concluded
that it was not possible to adopt the NQF endorsed measure ``Percent of
Residents or Patients with Pressure Ulcers That Are New or Worsened
(short-stay)'' (NQF 0678) because it is a risk-adjusted
measure. Public comments revealed that the ``Quality Indicator''
section of the IRF-PAI did not contain the data elements that would be
needed to calculate a risk-adjusted measure. As a result, we decided
to: (1) adopt an application of the NQF 0678 pressure ulcer
measure that was a non-risk-adjusted pressure ulcer measure (numerator
and denominator data only); (2) collect the data required for the
numerator and the denominator using the current version of the IRF-PAI;
(3) delay public reporting of pressure ulcer measure results until we
could amend the IRF-PAI to add the data elements necessary for risk-
adjusting NQF 0678, and then (4) adopt the NQF-endorsed
version of the measure covering the IRF setting through rulemaking (77
FR 68507).
a. National Healthcare Safety Network (NHSN) Catheter Associated
Urinary Tract Infection (CAUTI) Outcome Measure (NQF 0138)
In the CY 2013 OPPS/ASC final rule we adopted the current version
of NQF 0138 NHSN Catheter Associated Urinary Tract Infection
(CAUTI) Outcome Measure (replacing an application of this measure which
we initially adopted in the FY 2012 IRF PPS (76 FR 47874 through
47886). The NQF endorsed measure applies to the FY 2015 IRF PPS annual
increase factor and all subsequent annual increase factors (77 FR 68504
through 68505).
Since the publication of the CY 2013 OPPS/ASC final rule, the NHSN
CAUTI measure has not changed. Furthermore, we have not removed,
suspended, or replaced this measure and it remains an active part of
the IRF QRP. Additional information about this measure can be found at
https://www.qualityforum.org/QPS/0138. Our procedures for data
submission for this measure have also remained the same. IRFs should
continue to submit their CAUTI measure data to the Centers for Disease
Control and Prevention (CDC) NHSN. Details regarding submission of IRF
CAUTI data to NHSN can be found at the NHSN Web site at https://www.cdc.gov/nhsn/inpatient-rehab/.
We received several comments related to this previously finalized
measure, NQF 0138, and some other previously finalized
measures, raising some questions about our current policies. While we
greatly appreciate the commenters' views on such previously finalized
measures and policies, we did not make any proposals relating to them
in the FY 2014 IRF PPS proposed rule (78 FR 26880). As such, we will
not, in general, be addressing them here. However, we will consider all
of these views for future rulemaking and program development. We have
responded, however, to a few comments in which commenters asked only
for a clarification related to an existing policy and/or measure.
Comment: Several commenters, including MedPAC, expressed that CMS
should focus on measures that reflect the success of rehabilitation
care, mentioning specifically functional improvement and/or discharge
to community. One commenter suggested these measures be used instead of
the ``process of care measures related to urinary tract infections and
pressure ulcers''.
Response: We appreciate the commenter's suggestion. We would like
to thank MedPAC and the other commenters for their comments. We also
agree that a discharge to community measure would likely be very
important to beneficiaries and serve as a useful corollary to the 30-
day readmissions measure we proposed in the FY 2014 IRF PPS proposed
rule, because it reflects whether a patient returns home, rather than
returning directly to the acute hospital or another inpatient facility.
We have developed a strategic plan related to the types of quality
measures that we will propose over the next several rulemaking cycles.
Patient experience of care and care coordination measures, such as a
discharge to community measure, are included in this plan. We have
previously discussed a measure of discharge to community in one of the
IRF-QRP Technical Expert Panels. We also agree with MedPAC's suggestion
that adding quality measures that assess functional improvement should
be a priority for the IRFQRP. At this time, our quality measure
development contractor is completing the development of quality
measures that specifically focus on outcomes related to improvement of
a patient's functional status, and these measures have been presented
to the Measures Application Partnership (MAP) to determine whether the
MAP at least supports the direction of the concept behind these
measures (since the measures are not yet complete). The MAP) and its
functions are described in detail at https://www.qualityforum.org/map/.
The development of these measures has necessitated several years of
work, involving testing, revisions, and expert review. However, we are
now close to being in our final stages of the development of these
measures, and will present them to the MAP this year. Before proposing
to adopt these measures, we want to take all steps necessary to ensure
that the introduction of functional measurement into the IRF-QRP is
comprehensive in design so as to be meaningful to our beneficiaries,
Medicare and our stakeholders.
Comment: One commenter expressed concern about changes made by the
CDC to the CAUTI infection definitions in 2013, and the pending review
with further changes to the definition likely in early 2014. This
commenter believed that instability of data between baseline years and
into CY 2014 can be expected due to the changes in the CAUTI
definitions. One commenter expressed support for the continued use of
the CAUTI measure, but suggested that training could help to support a
smooth transition when the new reporting definitions are introduced.
The commenter further encouraged CMS to provide any training necessary
that will support a smooth transition when new reporting definitions
are introduced.
Response: According to the measure steward, Centers for Disease
Control and Prevention (CDC), NHSN's definition of CAUTI did not change
in 2013, and the revised criteria in 2013 for what constitutes an
healthcare-associated infection (HAI) amounts to providing operational
guidance--already widely in use before the guidance was published--that
makes identifying HAIs more consistent across reporting healthcare
facilities. There was no change in the NQF measure specification; the
CAUTI measure remains the same. As a result, CAUTI data reported for
infections occurring in 2013 can be compared to the CAUTI baseline
established using CAUTI date reported for infections occurring in 2009.
In short, there was no significant change in the measure and the
changes in HAI criteria have no bearing on reporting obligations. We
will continue to work with the NHSN to provide provider training on any
changes affecting the IRF QRP.
[[Page 47904]]
Comment: One commenter expressed concern about the adequacy of the
risk adjustment of the CAUTI measure, especially with regard to its
impact on IRFs caring for patients with a spinal cord injury.
Response: With regard to risk adjustment, the CAUTI measure relies
on robust statistical analysis to inform its risk adjustment
methodologies to ensure that the measure is accurately reported. We
will work with the CDC to continue to collect data and to explore the
possibility of refining the CAUTI measure through NQF measure
maintenance and future rulemaking, if the change is substantive, as
more data is collected.
b. Application of Percent of Residents or Patients With Pressure Ulcers
That Are New or Worsened (Short-Stay) (NQF 0678)
In the CY 2103 OPPS/ASC final rule (77 FR 68500 through 68507) we
finalized adoption of a non-risk-adjusted application of this measure
using the current version of the IRF-PAI. To adopt the NQF-endorsed
version of this measure, we must update the existing IRF-PAI to include
the additional data elements necessary to risk adjust this measure. We
also delayed public reporting of pressure ulcer measure results until
we amend the IRF-PAI to add the data elements necessary for risk
adjusting NQF 0678 (77 FR 68507). We are not making any
changes to the application of measure 0678 finalized in the CY
2013 OPPS/ASC final rule for the FY 2015 and FY 2016 IRF PPS annual
increase factors. Furthermore, we have not removed, suspended, or
replaced this measure for those specific annual increase factors and
the application of NQF 0678 remains an active part of the IRF
QRP for that purpose. Additional information about this measure can be
found at https://www.qualityforum.org/QPS/0678. Our procedures for data
submission for this measure also have remained the same. IRFs should
continue to collect and submit pressure ulcer measure data during CY
2013 using the IRF-PAI released on October 1, 2012 for the FY 2015 IRF
PPS annual increase factor. Further, IRFs should continue to collect
and submit pressure ulcer measure data during the first three quarters
of CY 2014 using the IRF-PAI released on October 1, 2012 for the FY
2016 IRF PPS annual increase factor.
In the May 8, 2013 proposed rule (78 FR 26909 through 26924), we
did propose to adopt a revised version of the IRF-PAI starting October
1, 2014 for the FY 2017 PPS annual increase factor and subsequent
fiscal years annual increase factors. We noted that the proposed
revisions to the IRF-PAI would allow collection of data elements
necessary for risk adjustment of NQF 0678, which is required
by the NQF endorsed version of the measure. We also proposed to replace
the current application of NQF 0678 and adopt instead the NQF
endorsed version of this measure. We have discussed these proposed
changes in more detail in section C. below.
Table 10--Quality Measures Finalized in the CY 2013 OPPS/ASC Final Rule
Affecting the FY 2015 IRF Annual Increase Factor and Subsequent Year
Increase Factors
------------------------------------------------------------------------
NQF measure ID Measure title
------------------------------------------------------------------------
NQF 0138............ National Health Safety Network (NHSN)
Catheter-associated Urinary Tract
Infection (CAUTI) Outcome Measure.\+\
Application of NQF 0678. Pressure Ulcers That are New or Worsened
(Short-Stay).*
------------------------------------------------------------------------
\+\ Using CDC/NHSN.
* Using October 1, 2012 release of IRF-PAI.
C. New IRF QRP Quality Measures Affecting the FY 2016 and FY 2017 IRF
PPS Annual Increase Factor, and Subsequent Year Increase Factors
1. General Considerations Used for Selection of Quality Measures for
the IRF QRP
In the May 8, 2013 proposed rule (78 FR 26909 through 26924), we
noted that the successful development of an IRF quality reporting
program that promotes the delivery of high-quality healthcare services
in IRFs is our paramount concern. We discussed many of the factors we
had taken into account in selecting measures to propose in the May 8,
2013 proposed rule (78 FR 26909 through 26924), and we refer readers
there for details about our selection process. We do wish to note here
that, in our measure selection activities for the IRF QRP, we must take
into consideration input we receive from a multi-stakeholder group, the
Measure Applications Partnership (MAP), which is convened by the NQF as
part of a pre-rulemaking process that we have established and are
required to follow under section 1890A of the Act. The MAP is a public-
private partnership comprised of multi-stakeholder groups convened by
the NQF for the primary purpose of providing input to CMS on the
selection of certain categories of quality and efficiency measures, as
required by section 1890A(a)(3) of the Act. By February 1st of each
year, the NQF must provide MAP input to CMS. We have taken the MAP's
input into consideration in selecting measures for this rule. Input
from the MAP is located at https://www.qualityforum.org/Setting_Priorities/Partnership/Measure_Applications_Partnership.aspx. We also
take into account national priorities, such as those established by the
National Priorities Partnership (NPP) at https://www.qualityforum.org/Setting_Priorities/NPP/National_Priorities_Partnership.aspx, the HHS
Strategic Plan at https://www.hhs.gov/secretary/about/priorities/priorities.html, and the National Strategy for Quality Improvement in
Healthcare at https://www.ahrq.gov/workingforquality/nqs/nqs2012annlrpt.pdf. To the extent practicable, we have sought to adopt
measures that have been endorsed by a national consensus organization,
recommended by multi-stakeholder organizations, and developed with the
input of providers, purchasers/payers, and other stakeholders.
2. New Measures for the FY 2016 and FY 2017 Annual Increase Factors
For the FY 2016 IRF PPS annual increase factor, in addition to
retaining the previously discussed CAUTI and Pressure Ulcer measures,
we proposed in the May 8, 2013 proposed rule (78 FR 26909 through
26924), to adopt one new measure: Influenza Vaccination Coverage among
Healthcare Personnel Measure (NQF 0431). In addition, for the
FY 2017 IRF PPS annual increase factor, we proposed to adopt three
quality measures: (1) All-Cause Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient Rehabilitation Facilities, (2)
Percent of Residents or Patients Who Were Assessed and Appropriately
Given the Seasonal Influenza Vaccine (Short-Stay) (NQF 0680),
and (3) the NQF endorsed version of Percent of Residents or Patients
with Pressure Ulcers that are New or Worsened (Short-Stay) (NQF
[[Page 47905]]
0678). We discuss these measures in more detail below in this
final rule.
2. New Quality Measures for Quality Data Reporting Affecting the FY
2016 IRF PPS Annual Increase Factor
a. IRF QRP Measure 1: Influenza Vaccination Coverage Among
Healthcare Personnel (NQF 0431)
In the FY 2014 IRF PPS proposed rule (78 FR 26880), we proposed to
adopt the CDC developed Influenza Vaccination Coverage among Healthcare
Personnel (NQF 0431) measure that is currently collected by
the CDC via the NHSN. This measure reports on the percentage of IRF
health care personnel (HCP) who receive the influenza vaccination. We
noted that this measure was included on the CMS' List of Measures under
Consideration for December 1, 2012 and that this measure was reviewed
by the MAP and was included in the MAP input that was transmitted to
CMS on February 1, 2013, as required by section 1890A(a)(3) of the Act.
The MAP fully supported the use of this measure in the IRF setting,
indicating it promotes alignment across quality reporting programs (for
example, with Long-Term Care Hospital Quality Reporting Program (LTCHQR
Program) and Hospital Inpatient Quality Reporting Program (Hospital
IQR)) and addresses a core measure concept.
Health care personnel are at risk for both acquiring influenza from
patients and transmitting it to patients, and health care personnel
often come to work when ill.\2\ One early report of health care
personnel influenza infections during the 2009 H1N1 influenza pandemic
estimated 50 percent of infected health care personnel had contracted
the influenza virus from patients or coworkers in the healthcare
setting.\3\
---------------------------------------------------------------------------
\2\ Wilde JA, McMillan JA, Serwint J, et al. Effectiveness of
influenza vaccine in healthcare professionals: A randomized trial.
JAMA. 1999; 281:908-913.
\3\ Harriman K, Rosenberg J, Robinson S, et al. Novel influenza
A (H1N1) virus infections among health-care personnel--United
States, April-May 2009. MMWR Morb Mortal Wkly Rep. 2009; 58(23):
641-645.
---------------------------------------------------------------------------
The CDC Advisory Committee on Immunization Practices (ACIP)
guidelines recommends that all health care personnel get an influenza
vaccination every year to protect themselves and patients.\4\ Even
though levels of influenza vaccination among health care personnel have
slowly increased over the past 10 years, less than 50 percent of health
care personnel each year received the influenza vaccination until the
2009 and 2010 season, when an estimated 62 percent of health care
personnel got a seasonal influenza vaccination. In the 2010 and 2011
season, 63.5 percent of health care personnel reported an influenza
vaccination. Increased influenza vaccination coverage among health care
personnel is expected to result in reduced morbidity and mortality
related to influenza virus infection among patients, aligning with the
NQS's aims of better care and healthy people/communities. This measure
has been finalized for reporting in the Hospital IQR Program, LTCHQR
Program, and the Ambulatory Surgical Center Quality Reporting Program
(ASCQR Program).
---------------------------------------------------------------------------
\4\ Fiore AE, Uyeki TM, Broder K, et al. Prevention and control
of influenza with vaccines: Recommendations of the Advisory
Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep.
2010. 59(08): 1-62.
---------------------------------------------------------------------------
We refer readers to the NHSN Manual, Healthcare Personnel Safety
Component Protocol Module, Influenza Vaccination and Exposure
Management Modules, which is available at the CDC Web site at https://www.cdc.gov/nhsn/inpatient-rehab/hcp-vacc/ for measure
specifications and additional details.
In the FY 2014 IRF PPS proposed rule (78 FR 26909 through 26924),
we proposed that the Influenza Vaccination Coverage Among Healthcare
Personnel measure (NQF 0431) have its own reporting period to
align with the influenza vaccination season, which is defined by the
CDC as October 1st (or when the vaccine becomes available) through
March 31st. We further proposed that IRFs will submit their data for
this measure to the NHSN (https://www.cdc.gov/nhsn/). The National
Healthcare Safety Network (NHSN) is a secure Internet-based healthcare-
associated infection tracking system maintained by the CDC and can be
utilized by all types of health care facilities in the United States,
including IRFs. NHSN collects data via a web-based tool hosted by the
CDC. Information on the NHSN system, including protocols, report forms,
and guidance documents can be found at the provided web link: https://www.cdc.gov/nhsn/. NHSN will submit data to CMS on behalf of the
facility. We also proposed that for the FY 2016 IRF PPS annual increase
factor data collection will cover the period from October 1, 2014 (or
when the vaccine becomes available) through March 31, 2015 (78 FR 26909
through 26924).
Details related to the use of NHSN for data submission and
information on definitions, numerator data, denominator data, data
analyses, and measure specifications for the Influenza Vaccination
Coverage among Healthcare Personnel (NQF 0431) measure can be
found at https://www.cdc.gov/nhsn/inpatient-rehab/hcp-vacc/.
Because IRFs are already using the NHSN for the submission of CAUTI
data, the administrative burden related to data collection and
submission for this measure under the IRF QRP should be minimal.
While IRFs can enter information in NHSN at any point during the
influenza season for the healthcare personnel (HCP) influenza
vaccination measure NQF 0431, data submission is only required
once per influenza season, unlike the other measure finalized for the
IRF QRP that utilizes NHSN (CAUTI measure NQF 0138). For
example, IRFs can choose to submit HCP influenza vaccination data on a
monthly basis. However, each time an IRF submits these data, it will be
asked to provide a cumulative total of vaccinations for the ``current''
influenza season. Thus, entering this information at the end of the
influenza season would yield the same total number of vaccinations. The
NHSN system will not track the individual number of vaccinations on a
monthly basis, but, rather, will track the cumulative total of
vaccinations for the ``current'' influenza season. We proposed that the
final deadline associated with this measure should align with the other
CMS deadline for IRF HAI (CAUTI) reporting into NHSN, which is May
15th. IRF QRP data collection timelines and submission deadlines are
discussed below.
Also, as noted in the proposed rule, data collection for this
measure is not 12 months, as with other measures, but is approximately
6 months (that is, October 1st (or when the vaccine becomes available)
through March 31st of the following year). This data collection period
is applicable only to NQF 0431 Influenza Vaccination Coverage
Among Healthcare Personnel, and not applicable to any other IRF QRP
measures, proposed or adopted, unless explicitly stated. The measure
specifications for this measure can be found at https://www.cdc.gov/nhsn/inpatient-rehab/hcp-vacc/ and at https://www.qualityforum.org/QPS/0431.
We sought public comments on the Influenza Vaccination Coverage
among Healthcare Personnel (NQF 0431) measure for the FY 2016
IRF PPS annual increase factor and subsequent years. The responses to
public comments on our adopting NQF 0431 are discussed below
in this section of the final rule.
Comment: Several commenters expressed unconditional agreement with
our proposal to adopt the Influenza Vaccination Coverage among
Healthcare Personnel measure in the IRF QRP. However, a majority of
commenters
[[Page 47906]]
expressed a conditional support for this measure in which they support
the use of the measure by IRFs that are freestanding hospitals, but do
not support the use of this measure by IRF units that are affiliated
with an acute care facility. These commenters believe that IRF units
should be excluded from this measure because most IPPS hospitals
include IRF unit employees in reporting health care personnel influenza
vaccination rates to NHSN under the IPPS Quality Reporting program.
Response: The intent of NQF measure 0431 is to incentivize
full influenza vaccination coverage of all healthcare workers (HCWs)
within a specific kind of facility and to measure the extent to which
that goal is accomplished within that facility. We regard an IRF unit
that is affiliated with an acute care facility to be its own separate
type of facility, with its own responsibility for HCW vaccination and
data submission. The submission of data by an IRF unit that is
affiliated with an acute care facility will constitute location-
specific reporting to NHSN for the HCWs who have worked within that
specific unit. These IRF units will need to account for any staff that
work within the unit for one day or more between Oct 1st and March 31st
of a flu season and fall within the 3 required categories of staff as
defined by the NHSN protocol, including payroll employees, licensed
independent practitioners, and students/trainees/volunteers. The acute
care facility will have the same requirements for submission of data,
but will need to cover all of its inpatient care units, which will
include any existing IRF units that are affiliated with an acute care
facility, and will essentially be reporting facility-wide counts. The
data submitted for these two separate requirements will never be summed
together.
Comment: Many of the commenters requested that CMS clarify that the
data collection period for the influenza vaccine begins on October 1st
and not at an earlier date, should the influenza vaccination become
available at any time before October 1st.
Response: NHSN specifies the reporting period for influenza vaccine
coverage in its protocol. Vaccine coverage reporting, that is, measure
numerator data, is required based on data collected from Oct 1 or
whenever the vaccine becomes available. This statement ensures that if
the vaccine is available early, any vaccines given before Oct 1 can be
credited toward vaccination coverage, and if the vaccine is late, then
the vaccination counts are to begin as soon as possible after Oct 1.
For the denominator count, IRFs will need to account for any staff
that work within the unit for 1 day or more between Oct 1st and March
31st of a flu season and fall within the 3 required categories of staff
as defined by the NHSN protocol, including payroll employees, licensed
independent practitioners, and students/trainees/volunteers.
Final Decision: Having carefully considered the comments we
received on the Influenza Vaccination Coverage among Healthcare
Personnel (NQF 0431), we are finalizing the adoption of this
measure for use in the IRF QRP.
Table 11--Summary of Quality Measures Affecting the FY 2016 IRF PPS
Annual Increase Factor
------------------------------------------------------------------------
-------------------------------------------------------------------------
Continued Measure Affecting the FY 2015 Annual Increase Factor and
Subsequent Year Annual Increase Factors:
NQF 0138: National Health Safety Network (NHSN)
Catheter-associated Urinary Tract Infection (CAUTI) Outcome
Measure. \+\
Continued Measure Affecting the FY 2015 and FY 2016 Annual Increase
Factors:
Application of NQF 0678: Percent of Residents with
Pressure Ulcers That are New or Worsened (Short-Stay). *
New IRF QRP Measure Affecting the FY 2016 IRF PPS Annual Increase Factor
and Subsequent Year Increase Factors:
NQF 0431: Influenza Vaccination Coverage among
Healthcare Personnel. \+\
------------------------------------------------------------------------
\+\ Using CDC NHSN.
* Using October 1, 2012 release of IRF-PAI.
3. Quality Measures for Quality Data Reporting Affecting the FY 2017
IRF PPS Annual Increase Factor and Subsequent Years
In the FY 2014 IRF PPS proposed rule (78 FR 26909 through 26924),
we proposed to adopt 2 additional quality measures and replace an
existing quality measure for the IRF QRP for the FY 2017 annual
increase factor and subsequent year increase factors. The new measures
we proposed are: (1) All-Cause Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient Rehabilitation Facilities, and (2)
Percent of Residents or Patients Who Were Assessed and Appropriately
Given the Seasonal Influenza Vaccine (Short-Stay) (NQF 0680).
In addition, we proposed to replace the non-risk adjusted application
of Percent of Residents or Patients with Pressure Ulcers That Are New
or Worsened (short-stay) (NQF 0678) with adoption of the NQF-
endorsed version of this measure. A summary of the public comments
received and our responses to comments are discussed below.
a. IRF QRP Measure 1: All-Cause Unplanned Readmission Measure
for 30 Days Post Discharge From Inpatient Rehabilitation Facilities
In the May 8, 2013 proposed rule (78 FR 26909 through 26924), we
proposed to adopt an All-Cause Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient Rehabilitation Facilities. This
measure estimates the risk-standardized rate of unplanned, all-cause
hospital readmissions for cases discharged from an IRF who were
readmitted to a short-stay acute care hospital or LTCH, within 30 days
of an IRF discharge. We noted that this is a claims-based measure which
will not require reporting of new data by IRFs, and hence, will not be
used to determine IRF reporting compliance for the IRF QRP.
Addressing unplanned hospital readmissions is a high priority for
HHS and CMS as our focus continues on promoting patient safety,
eliminating healthcare associated infections, improving care
transitions, and reducing the cost of healthcare. Readmissions are
costly to the Medicare program and have been cited as sensitive to
improvements in coordination of care and discharge planning for
patients.\5\ Although the literature on readmissions is mainly
concerned with discharges from short-term acute hospitals, the same
issues of discharge planning, communications and coordination arise at
discharge from other inpatient facilities.
---------------------------------------------------------------------------
\5\ Federal Register/Vol. 76, No. 160/Thursday, August 18, 2011/
Rules and Regulations, C1a.
---------------------------------------------------------------------------
IRFs provide intensive rehabilitation services to patients after an
injury, illness, or surgery. According to MedPAC, the average length of
stay for most patients in an IRF is 13.1 days.\6\ In 2010, almost
360,000 Medicare Fee-for-Service (FFS) beneficiaries received care
[[Page 47907]]
in IRFs and cost the Medicare FFS program over $6 billion dollars. The
unadjusted readmission rate to an IPPS hospital in the 30 days
following an IRF discharge was about 15 percent.\7\ With such a large
proportion of patients being readmitted to a hospital level of care, we
proposed a risk-adjusted measure of readmission rate, the All-Cause
Unplanned Readmission Measure for 30 Days Post Discharge from Inpatient
Rehabilitation Facilities. An IRF's readmission rate is affected by
complex and critical aspects of care, such as communication between
providers or between providers and patients; prevention of, and
response to, complications; patient safety; and coordinated transitions
to the community or a less intense level of care. While disease-
specific measures of readmission are useful in identifying deficiencies
in care for specific groups of patients, they account for only a small
minority of total readmissions. By contrast, a facility-wide, all-cause
readmission reflects a broader assessment of the quality of care in
IRFs, and may consequently better promote quality improvement and
inform consumers about quality.
---------------------------------------------------------------------------
\6\ MedPAC, Report to Congress, Medicare Payment Policy, March,
2012. https://www.medpac.gov/chapters/Mar12_Ch09.pdf.
\7\ Bernard SL, Dalton K, Lenfestey N F, Jarrett NM, Nguyen KH,
Sorensen AV, Thaker S, West ND. Study to support a CMS Report to
Congress: Assess feasibility of extending the hospital-acquired
conditions--present on admission IPPS payment policy to non-IPPS
payment environments. Prepared for the Centers for Medicare &
Medicaid Services (CMS Contract No. HHSM-500-T00007). 2011.
---------------------------------------------------------------------------
While some readmissions are unavoidable, such as those resulting
from the inevitable progression of disease or worsening of chronic
conditions, readmissions may also result from poor quality of care or
inadequate transitions between care settings. Randomized controlled
trials in short-stay acute care hospitals have shown that improvement
in the following areas can directly reduce hospital readmission rates:
Quality of care during the initial admission; improvement in
communication with patients, their caregivers and their clinicians;
patient education; pre-discharge assessment; and coordination of care
after discharge. Successful randomized trials have reduced 30-day
readmission rates by 20 to 40 percent.8 9 10 11 12 13 14 and
a 2011 meta-analysis of randomized clinical trials found evidence that
interventions associated with discharge planning helped to reduce
readmission rates,\15\ illustrating how hospitals may influence
readmission rates through best practices.
---------------------------------------------------------------------------
\8\ Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM,
Johnson AE, et al. A reengineered hospital discharge program to
decrease rehospitalization: a randomized trial. Ann Intern Med
2009;150(3):178-87.
\9\ Coleman EA, Smith JD, Frank JC, Min SJ, Parry C, Kramer AM.
Preparing patients and caregivers to participate in care delivered
across settings: the Care Transitions Intervention. J Am Geriatr Soc
2004;52(11):1817-25.
\10\ Courtney M, Edwards H, Chang A, Parker A, Finlayson K,
Hamilton K. Fewer emergency readmissions and better quality of life
for older adults at risk of hospital readmission: a randomized
controlled trial to determine the effectiveness of a 24-week
exercise and telephone follow-up program. J Am Geriatr Soc
2009;57(3):395-402.
\11\ Garasen H, Windspoll R, Johnsen R. Intermediate care at a
community hospital as an alternative to prolonged general hospital
care for elderly patients: a randomized controlled trial. BMC Public
Health 2007;7:68.
\12\ Koehler BE, Richter KM, Youngblood L, Cohen BA, Prengler
ID, Cheng D, et al. Reduction of 30-day post discharge hospital
readmission or emergency department (ED) visit rates in high-risk
elderly medical patients through delivery of a targeted care bundle.
J Hosp Med 2009;4(4):211- 218.
\13\ Naylor M, Brooten D, Jones R, Lavizzo-Mourey R, Mezey M,
Pauly M. Comprehensive discharge planning for the hospitalized
elderly. A randomized clinical trial. Ann Intern Med
1994;120(12):999-1006.
\14\ Naylor MD, Brooten D, Campbell R, Jacobsen BS, Mezey MD,
Pauly MV, et al. Comprehensive discharge planning and home follow-up
of hospitalized elders: a randomized clinical trial. JAMA
1999;281(7):613-20.
\15\ Naylor MD, Aiken LH, Kurtzman ET, Olds DM, Hirschman KB.The
Importance of Transitional Care in Achieving Health Reform. Health
Affairs 2011; 30(4):746-754.
---------------------------------------------------------------------------
Because many studies have shown readmissions to be related to
quality of care, and that interventions have been able to reduce 30-day
readmission rates, we believe it is appropriate to include an all-
condition readmission rate as a quality measure in the IRF QRP.
Promoting quality improvements leading to successful transitions of
care for patients moving from the IRF setting to the community or
another post-acute care setting, and reducing preventable facility-wide
readmission rates, is consistent with the National Quality Strategy
priorities of safer, better coordinated care and lower costs.
Our approach to developing this measure is not the same as, but is
in many ways very similar to NQF-endorsed Hospital-Wide (HWR) Risk-
Adjusted All-Cause Unplanned Readmission Measure (NQF 1789)
(https://www.qualityforum.org/Publications/2012/07/Patient_Outcomes_All-Cause_Readmissions_Expedited_Review_2011.aspx) finalized for
the Hospital IQR Program in the FY 2013 IPPS/LTCH PPS Final Rule (FR 77
53521 through 53528). To the extent appropriate, we have harmonized the
IRF measure with the HWR measure and other measures of readmission
rates developed for post-acute care (PAC) settings, including LTCHs. We
have provided more details about these measures and our attempts to
harmonize with them below.
The All-Cause Unplanned Readmission Measure for 30 Days Post
Discharge from Inpatient Rehabilitation Facilities measure assesses
returns to short-stay acute care hospitals or LTCHs within 30 days of
discharge from an IRF to the community or another care setting of
lesser intensity. Patient readmissions are tracked using Medicare
claims data for 30 days after discharge, to the date of patient death,
if the patient dies within 30 days of discharge. 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 on the part of the IRF.
A model developed by a CMS measure development contractor predicts
admission rates while accounting for patient demographics, primary
condition in the prior short stay, comorbidities, and a few 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 facility. Similar to the Hospital
IQR Program hospital-wide readmission measure, the IRF QRP measure is
the ratio of the number of risk-adjusted predicted unplanned
readmissions for each individual IRF, including the estimated facility
effect, to the average number of risk-adjusted predicted unplanned
readmissions for the same patients treated at the average IRF. A ratio
above one indicates a higher than expected readmission rate, or lower
level of quality, while a ratio below one indicates a lower than
expected readmission rate, or higher level of quality. (The methodology
report detailing the development of the IPPS hospital-wide measure and
the NQF report may be downloaded from: https://www.qualityforum.org/Publications/2012/07/Patient_Outcomes_AllCause_Readmissions_Expedited_Review_2011.aspx.)
The patient population includes IRF patients who:
Were discharged alive from the IRF.
Had 12 months of Medicare Part A, Fee-for-Service coverage
prior to the IRF stay.
Had 30 days of Medicare Part A, Fee-for-Service coverage
post discharge.
Had an acute care facility (IPPS, CAH or psychiatric
hospital) stay within the 30 days prior to the IRF stay.
Were aged 18 years or above when admitted to the IRF.
[[Page 47908]]
As with the Hospital IQR Program hospital-wide readmission measure,
patients with medical treatment for cancer are excluded. Studies of
this population that were reviewed for the Hospital IQR Program
readmission measure showed them to have a different trajectory of
illness and mortality than other patient populations.\16\ The measure
also excludes patients who died during the IRF stay, IRF patients under
the age of 18, or IRF patients discharged against medical advice (AMA).
---------------------------------------------------------------------------
\16\ National Quality Forum. ``Patient Outcomes: All-Cause
Readmissions Expedited Review 2011''. July 2012. pp12.
---------------------------------------------------------------------------
Readmissions that are not included in the measure are:
Transfers from an IRF to another IRF or acute care
facility.
Readmissions within the 30-day window that are usually
considered planned due to the nature of the procedures and principal
diagnoses of the readmission.
IRF stays with data that are problematic. (The Medicare
data files occasionally have anomalous records that indicate a person
is in two facilities or stays that overlap in dates, or are otherwise
potentially erroneous or contradictory.)
The planned readmission list includes the planned procedures
specified in the Hospital-Wide All-Cause Unplanned Readmission (HWR)
Measure (NQF 1789) used in the Hospital IQR Program, plus
other procedures that we determined in consultation with technical
expert panels. In addition to the list of planned procedures is a list
of diagnoses (provided at the link below in the planned readmission
criteria), which, if found as the principal diagnosis on the
readmission claim, would indicate that the procedure occurred during an
unplanned readmission. The planned readmissions criteria may be found
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Downloads/DRAFT-Specifications-for-the-Proposed-All-Cause-Unplanned-30-day-Post-IRF-Discharge-Readmission-Measure.pdf with a link to the latest planned readmissions criteria
used in the HWR at the end of Table 1.
A discharged patient is tracked until one of the following occurs:
(1) The 30-day period ends; (2) the patient dies; or (3) the patient is
readmitted to an acute level of care (short or long term). If multiple
readmissions occur, only the first is considered for this measure. If
the readmission is unplanned, it is counted as a readmission in the
measure rate. If the readmission is planned, the readmission is not
counted in the measure rate. The occurrence of a planned readmission
ends further tracking for readmissions in the 30-day window following
discharge from the IRF.
Readmission rates are risk-adjusted for patient case-mix
characteristics, independent of quality. The risk adjustment modeling
estimates the effects of patient characteristics on the probability of
readmission so they can be adjusted out when reporting the readmission
rates. The risk-adjustment model for IRFs accounts for demographic
characteristics, principal diagnosis, comorbidities, case-mix group in
the IRF, length of stay in the prior acute care facility, critical care
days in the prior acute care facility, number of acute care facility
stays in the prior year, and the occurrence of various surgery types in
the prior acute care facility stay. In modeling IRF readmissions, all
patients are included in a single model. We did not divide patients
into groups clinically, modeling separate patient types separately as
was done in the IPPS HWR measure. In the HWR there are five patient
cohorts, each modeled separately, and a combined score for the
facility. All IRF patients are modeled as one group, both because IRFs
have a substantially smaller patient population, restricting the
ability to create reasonably large subgroups, and the technical expert
panel did not recommend any such stratification.
While the HWR measure used 1 year of data, the smaller IRF patient
population led us to merge 2 years of data for the IRF QRP. This
approach is similar to that used by the Hospital IQR Program condition-
specific readmission measures, such as that for heart attack and heart
failure patients, which use 3 years of claims data. Increasing sample
size by merging multiple years produces more precise estimates of the
effects of all the risk adjusters and increases the sample size
associated with each facility. Larger patient samples are generally
better for meaningfully distinguishing facility performance. We
proposed this measure under the exception authority in section
1886(m)(5)(D)(ii) of the Act for the IRF QRP. This section provides
that in the case of a specified area or medical topic determined
appropriate by the Secretary for which a feasible and practical measure
has not been endorsed by the entity with a contract under section
1890(a) of the Act, the Secretary may specify a measure that is not so
endorsed as long as due consideration is given to measures that have
been endorsed or adopted by a consensus organization identified by the
Secretary.
We noted in the proposed rule we had not been able to identify an
NQF-endorsed readmission measure that was appropriate for the IRF
setting. In 2012, NQF endorsed hospital-wide readmission measures, the
National Committee for Quality Assurance (NCQA) measure intended for
health plans, Plan All-Cause Readmissions (NQF 1768), and CMS'
Hospital-Wide All-Cause Unplanned Readmission Measure (HWR) (NQF
1789), of which the latter is the model for the All-Cause
Unplanned Readmission Measure for 30 Days Post Discharge from Inpatient
Rehabilitation Facilities measure, proposed in the FY 2014 IRF PPS
proposed rule. This measure was present on CMS's List of Measures Under
Consideration, and the most recent MAP Pre-Rulemaking Report noted that
``readmission measures are also examples of measures that MAP
recommends be standardized across settings, yet customized to address
the unique needs of the heterogeneous PAC/LTC population'' (https://
www.qualityforum.org/Publications/2013/02/MAP_Pre-Rulemaking_Report_
_-February_2013.aspx (pp. 177-180)). Although the MAP supported the
direction of this measure, they cautioned that the readmission measure
required further development. The MAP has also continually noted the
need for ``care transition measures in PAC/LTC performance measurement
programs'' and stated that ``setting-specific admission and readmission
measures under consideration would address this need.'' \17\
---------------------------------------------------------------------------
\17\ 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.
---------------------------------------------------------------------------
In the May 8, 2013 proposed rule, we stated our intention to seek
NQF endorsement of the All-Cause Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient Rehabilitation Facilities measure.
We noted that because this is a claims-based measure not requiring
reporting of new data by IRFs, this measure will not be used to
determine IRF reporting compliance for the IRF QRP. We also stated that
we expected to begin reporting feedback to IRFs on performance of this
measure in CY 2016 and that initial provider feedback will be based on
CY 2013 and CY 2014 Medicare FFS claims data related to IRF
readmissions and that the readmission measure will be part of the IRF
public reporting program once public reporting
[[Page 47909]]
is implemented. We noted that details pertaining to this measure can be
found on the IRF Quality Reporting Program Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/. We invited stakeholders
to submit public comments in response to our proposal to adopt the All-
Cause Unplanned Readmission Measure for 30 Days Post Discharge from
Inpatient Rehabilitation Facilities. A summary of the public comments
received and our responses to comments are discussed below.
Comment: Many commenters have expressed concern that CMS has not
yet sought and obtained NQF endorsement for the IRF readmission
measure.
Response: We are aware this measure is not yet NQF-endorsed for the
IRF setting and are working to submit the measure for NQF review and
endorsement. Currently, we are working with contractors to submit the
measure for NQF endorsement in October 2013. For the time being, we
have chosen to adopt this measure by exercising our authority to
finalize a non-NQF endorsed measure when NQF endorsed measures are not
available or appropriate for a setting and the Secretary has given due
consideration to measures that have been endorsed or adopted by a
consensus organization identified by the Secretary. We were not able to
find a measure that was appropriate for the IRF setting.
Comment: Several commenters requested that additional risk
adjustors be added to the risk adjustment model for the IRF readmission
measure, including patient data such as function and social support, on
the IRF-PAI.
Response: The proposed readmission measure is a risk-standardized
readmission measure that adjusts for case-mix differences based on the
clinical status of the patient at the time of admission to the IRF.
That is, the measure is risk-adjusted for certain key variables that
are clinically relevant or have been found to have strong relationships
with the outcome, including age group, sex, comorbid diseases, history
of repeat admissions. We also include as adjusters the IRF case-mix
groups (CMGs). The 92 CMGs are patient classes based on information on
the IRF-PAI and are reported on claims. The CMG assigned to a patient
contain information on the reason for IRF treatment (impairment group),
functional status, and sometimes cognitive status and age group. These
data elements from claims further enhance risk adjustment which, along
with information from the IRF-PAI, are sufficient without requiring
linking the IRF-PAI assessments themselves. We will investigate in the
future if including data elements, such as function and social support,
directly from the IRF-PAI would produce substantive improvement of the
model.
Comment: Several commenters suggested that socioeconomic status and
social factors be added to the risk adjustment model for the IRF
readmission measure.
Response: The inclusion of factors related to socioeconomic status
(SES) has been raised in the context of the IPPS Hospital IQR measures
and our policy in that program omits them as explicit risk adjusters.
Medicaid dual eligibility, which is related to income, is a
socioeconomic factor, and is also not accounted for explicitly in IQR
measures. The IRF measure harmonizes with the other readmission
measures in that respect (the IQR and the final long-term care hospital
readmission measure). The effect of SES is similar in the case of IRFs
to the effects in the IPPS setting and the reasoning for not explicitly
accounting for SES is similar. The effect of levels of SES is captured
to a great extent by other variables included in the model. The
readmission measure is a risk-standardized readmission measure that
adjusts for case-mix differences based on the clinical status of the
patient at the time of admission to the hospital. That is, they are
risk-adjusted for certain key variables (for example, age, sex,
comorbid diseases, and a history of repeat admissions) that are
clinically relevant and/or have been found to have strong relationships
with the outcome. To the extent that race or SES results in certain
patient groups having a worse medical condition profile, those factors
are accounted for in the measure.
These measures are not otherwise adjusted for other factors such as
race or English language proficiency. We believe such additional
adjustments are not appropriate because the association between such
patient factors and health outcomes can be due, in part, to differences
in the quality of health care received by groups of patients with
varying race/language/SES. Differences in the quality of health care
received by certain racial and ethnic groups may be obscured if the
measures risk-adjust for race and ethnicity. In addition, risk-
adjusting for patient race, for instance, may suggest that hospitals
with a high proportion of minority patients are held to different
standards of quality than hospitals treating fewer minority patients.
We appreciate the concerns of hospitals that care for
disproportionately large numbers of disadvantaged populations. Our
analysis indicates that better quality of care is achievable regardless
of the demographics of the hospital's patients.
Comment: Many commenters, including MedPAC, suggested the IRF
readmission measure should focus on avoidable or related
hospitalizations.
Response: The issue of all-cause readmissions as opposed to a more
focused set of readmission types has been raised in other contexts such
as the HWR IQR measure. Discussions with technical experts have led us
to prefer using an all-cause measure rather than a condition-specific
readmissions measure. A measure of avoidable or related readmissions is
possible when the population being measured is narrowly defined and
certain complications are being targeted. For broader measures, a
narrow set of readmission types is not practical. In addition,
readmissions may be clinically related even if they are not
diagnostically related. A patient may have comorbid conditions that are
unrelated to the reason for rehabilitation. If not properly dealt with
in discharge planning a readmission for such a condition may become
more likely. One of the primary purposes of a readmission measure is to
encourage improved transitions at discharge, a choice among discharge
destinations and care coordination. A readmission can occur that is
less related to the primary condition being treated in the IRF than to
the coordination of care post-discharge. That said, we have chosen to
reduce the all-cause readmission set by excluding readmissions that are
normally for planned or expected diagnosis and procedures. We augmented
the research for the Hospital IQR set of planned readmissions for the
IRF setting with recommendations and input from a TEP in the field of
post-acute care (including IRFs). Nearly 9 percent of readmissions are
considered planned. In the case where the readmission is due to a
random event, such as a car accident, we expect these events to be
randomly distributed across hospitals.
Comment: Several commenters indicated that the readmission measure
may have the unintended consequence of reducing access to IRF care.
Response: We recognize that in some cases, hospital readmission
will occur. Hospital readmission is not considered as a ``never event''
that hospitals are expected to reduce to zero. The measure of hospital
readmission is risk-adjusted to account for the factors that increase
this readmission risk, so that hospitals with a disproportionately
larger share of patients who are at high risk for readmission do not
perform worse on
[[Page 47910]]
the quality measure due to factors out of their control. We appreciate
the commenters' concerns but the risk adjustment is intended to adjust
for more complex patients so that access to care will not be reduced.
Nonetheless, as with all quality measures that we have implemented, we
will examine IRF data to monitor for potential unintended consequences.
Comment: Some commenters suggested that more than 2 years of data
be included in the readmissions measure to increase sample size.
Response: The 2 years of data for each reporting period is a
compromise between sample size and timeliness. In this case the total
number of IRF stays in 1 year of national data is much smaller than the
number of IPPS stays. However, 2 years of data generally yield good
sample sizes at the facility level. Ninety-five percent of facilities
have more than 100 patients averaged in their measure. We do not think
that 3 years of data is needed at this time. However, we will continue
to monitor this data over time and if there is a significant change in
number of IRF discharges in total or in individual facilities we will
reconsider the data requirement.
Final Decision: Having carefully considered the comments we
received on the All-Cause Unplanned Readmission Measure for 30 Days
Post Discharge from Inpatient Rehabilitation Facilities, we are
finalizing the adoption of this measure for use in the IRF QRP. We will
also continue to seek NQF endorsement of the All-Cause Unplanned
Readmission Measure for 30 Days Post Discharge from Inpatient
Rehabilitation Facilities measure.
b. IRF QRP Quality Measure 2: Percent of Residents or Patients
Who Were Assessed and Appropriately Given the Seasonal Influenza
Vaccine (Short-Stay) (NQF 0680)
In the May 8, 2013 proposed rule (78 FR 26909 through 26924), we
proposed to add the NQF 0680 Percent of Residents or Patients
who were assessed and Appropriately Given the Seasonal Influenza
Vaccination (Short-Stay) measure to the IRF QRP, and we proposed to
collect the data for this measure through the addition of data items to
the Quality Indicator section of the IRF-PAI. We noted that this
measure was on CMS's list of measures under consideration that were
reviewed by the MAP and was included in the MAP input that was
transmitted to CMS, as required by the pre-rulemaking process in
section 1890A(a)(3) of the Act. The MAP panel supported the use of this
measure in the IRF setting, noting that it promotes alignment across
settings and addresses a core measure concept.
Although influenza is prevalent among all population groups, the
rates of death and serious complications related to influenza are
highest among those ages 65 and older and those with medical
complications that put them at higher risk. The CDC reports that an
average of 36,000 Americans die annually from influenza and its
complications, and most of these deaths are among people 65 years of
age and over.\18\ In 2004, approximately 70,000 deaths were caused by
influenza and pneumonia, and more than 85 percent of these deaths were
among the elderly.\19\ Given that many individuals receiving health
care services in IRFs are elderly and/or have several medical
conditions, many IRF patients are within the target population for
influenza immunization.20 21
---------------------------------------------------------------------------
\18\ Centers for Medicare & Medicaid Services (2011, May). Adult
Immunization: Overview. Retrieved from https://www.cms.gov/Immunizations/.
\19\ Gorina Y, Kelly T, Lubitz J, et al. (2008, February).
Trends in influenza and pneumonia among older persons in the United
States. Aging Trends no. 8. Retrieved from https://www.cdc.gov/nchs/data/ahcd/agingtrends/08influenza.pdf.
\20\ Centers for Disease Control and Prevention. (2008,
September). Influenza e-brief: 2008-2009 flu facts for policymakers.
Retrieved from https://www.cdc.gov/washington/pdf/flu_newsletter.pdf.
\21\ Zorowitz, RD. Stroke Rehabilitation Quality Indicators:
Raising the Bar in the Inpatient Rehabilitation Facility. Topics in
Stroke Rehabilitation 2010; 17 (4):294-304.
---------------------------------------------------------------------------
We have also proposed to add the data elements needed for this
measure, as an influenza data item set, to the Quality Indicator
section of the IRF-PAI and that data for this measure will be collected
using a revised version of the IRF-PAI. Our proposed revision of the
IRF-PAI includes a new data item set designed to assess patients'
influenza vaccination status. The revised IRF-PAI would become
effective on October 1, 2014. We noted that these proposed data set
items are harmonized with data elements (O0250: Influenza Vaccination
Status) from the Minimum Data Set (MDS) 3.0 and LTCH CARE Data Set item
sets 22 23 and that the specifications and data elements for
this proposed measure are available in the MDS 3.0 QM User's Manual
available on our Web site at https://www.cms.gov/NursingHomeQualityInits/Downloads/MDS30QM-Manual.pdf.
---------------------------------------------------------------------------
\22\ Centers for Medicare & Medicaid Services. MDS 3.0 Item
Subsets V1.10.4 for the April 1, 2012 Release. Retrieved from
https://www.cms.gov/NursingHomeQualityInits/30_NHQIMDS30TechnicalInformation.asp.
\23\ The LTCH CARE Data Set Version 2.00, the data collection
instrument for the submission of the Percent of Residents or
Patients with Pressure Ulcers That are New or Worsened (Short-Stay)
measure and the Percent of Residents or Patients Who Were Assessed
and Appropriately Given the Seasonal Influenza Vaccine (Short-Stay)
measure, is currently under review by the Office of Management and
Budget (OMB) in accordance with the Paperwork Reduction Act (PRA)
https://www.gpo.gov/fdsys/pkg/FR-2013-02-01/pdf/2013-02155.pdf. The
LTCH CARE Data Set Version 1.01 was approved on April 24, 2012 by
OMB in accordance with the PRA. The OMB Control Number is 0938-1163.
Expiration Date April 30, 2013.
---------------------------------------------------------------------------
For purposes of this measure, the influenza vaccination season
consists of October 1st (or when the vaccine becomes available) through
March 31st each year. We proposed that while an IRF's compliance with
reporting quality data for this measure will be based on the calendar
year, the measure calculation and public reporting of this measure
(once public reporting is implemented) will be based on the influenza
vaccination season starting on October 1 (or when vaccine becomes
available) and ending on March 31 of the subsequent year.
The IRF-PAI Training Manual will indicate how providers should
complete these items during the time period outside of the vaccination
season (that is, prior to October 1st or when vaccine becomes available
and after March 31 of the following year). The measure specifications
for this measure, Percent of Residents or Patients Who Were Assessed
and Appropriately Given the Seasonal Influenza Vaccine (Short-Stay)
(NQF 0680), can be found on the CMS Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIQualityMeasures.html. Measure
specifications are located in the download titled: MDS 3.0 QM User's
Manual V6.0. Additional information on this measure can also be found
at https://www.qualityforum.org/QPS/0680.
In the May 8, 2013 proposed rule, we invited public comment on our
proposal to use the Percent of Residents or Patients Who Were Assessed
and Appropriately Given the Seasonal Influenza Vaccine (Short-Stay)
(NQF 0680) measure for the FY 2017 IRF PPS annual increase
factor and subsequent years. A summary of the public comments received
and our responses to comments are discussed below.
Comment: Several commenters indicated that they did not support the
patient immunization measure because it is not a core focus of care in
IRFs.
Response: While we appreciate the commenters' point of view,
influenza is a serious illness, especially for patients who are
elderly, immuno-compromised, or who have recently undergone surgery--
characteristics that describe
[[Page 47911]]
many of the patients in IRFs. CDC reports that pneumonia and influenza
were the 5th leading cause of death amongst individuals 65 and older
and that between 1997 and 2007, deaths among people aged 65 and older
accounted for 87.9 percent of deaths related to pneumonia and
influenza. Providing appropriate influenza vaccination is an important
preventative measure that is the responsibility of healthcare providers
in all settings. Although many patients may have already been offered
and/or received the influenza vaccine in the acute care setting, the
ultimate goal is that 100 percent of patients are assessed for
appropriate receipt of the influenza vaccine, and achieving this goal
requires the participation of all healthcare providers.
Comment: Several commenters expressed concern that the NQF
0680 Percent of Residents or Patients Who Were Assessed and
Appropriately Given the Seasonal Influenza Vaccine is redundant because
patients are offered many opportunities to receive the influenza
vaccination prior to admission into the IRF and are highly likely to
have already received the influenza vaccine in the acute care hospital.
Several commenters also noted that the patient influenza measure may
lead to over-vaccination of patients.
Response: We appreciate the comments and acknowledge the
commenters' concern for redundancy and over-vaccination. The
specifications for the Percent of Patients or Residents Who Were
Assessed and Appropriately Given the Seasonal Influenza Vaccine (short
stay) measure are written so that clinicians can document if patients
have already received the influenza vaccine for the current influenza
season. The numerator statement of the measure includes patients who
received the influenza vaccine, either inside or outside the IRF, for
the current influenza season. An IRF can report that a patient received
the vaccine prior to admission to the IRF and that it should not re-
vaccinate the patient for purposes of being able to report the patient
receiving a vaccination in the IRF. We acknowledge that facilities will
need to adhere to the principles of proper care coordination and
documentation to avoid over-immunization and under-immunization.
However, the specifications for the measure are designed to encourage
facilities to only vaccinate when the patient has not already received
the vaccination.
Comment: Several commenters requested guidance on how to track down
the influenza vaccination history of patients.
Response: We refer commenters to the measure description and
specifications of the NQF-endorsed measure at the NQF Web site https://www.qualityforum.org/QPS/0680. Further, to the extent that the
commenters are asking us to issue guidance on proper vaccine
documentation for purposes of ensuring that the receiving facility has
an accurate immunization history, we agree that care coordination is
essential to avoid over- as well as under-immunization. The influenza
vaccination measure, however, was not designed to offer guidance to
providers on how to vaccinate. The measure is specified to assess if
the patient was vaccinated, where the patient was vaccinated (if they
were vaccinated), or why the vaccination was not given (if the patient
was not vaccinated). Patients who were not vaccinated due to a
contraindication and patients who refused the vaccination are both
counted in the numerator and accounted separately in the numerator of
the measure. In a situation where vaccination status is unknown, we
would expect that the IRF provider would make a clinical judgment on
whether or not to vaccinate a patient, taking into account the
patient's medical history and current health status, as well as the
existing policy of their IRF on vaccination. The IRF must only report
the decision it made; that is, whether the vaccination was or was not
given. The measure does not require an IRF to provide a vaccination
that was not appropriate due to a contraindication or a patient
refusal, or to provide a vaccination to a patient who was already given
a vaccination outside of the IRF. We encourage all IRFs to vaccinate
according to their facilities' policies and the best clinical judgment
of the medical providers treating each individual patient and to
document the reason for the vaccination decision in the patient's
medical record.
Comment: Many commenters requested clarification about the data
collection period for the patient influenza vaccine.
Response: Starting with 2014-2015 Influenza season data collection
will be required for all patients in the IRF for 1 or more days between
October 1 and March 31. Clinicians can report that the reason a given
patient did not receive the vaccine was that the patient was not in the
facility during the current influenza vaccination season. Consistent
with NQF 0431, the vaccination measure for healthcare
personnel, it is the vaccinations received for patients in the IRF
during the influenza season (October 1st to March 31st) that will be
included in measure calculations and for the purpose of public
reporting.
Final Decision: After careful consideration of the public comments
received, we are finalizing our proposal to adopt the Percent of
Residents or Patients Who Were Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay) (NQF 0680) measure for
the FY 2017 IRF PPS annual increase factor and subsequent years. We are
additionally clarifying that data collection will begin starting with
the 2014-2015 Influenza season. Data collection for this and all
subsequent influenza seasons will be from October 1 through March 31 of
the following year. All data collection and submission guidelines will
be addressed in the IRF Quality Reporting Manual.
c. IRF QRP Quality Measure 3: Percent of Residents or Patients
With Pressure Ulcers That Are New or Worsened (Short-Stay) (NQF
0678)--Adoption of the NQF-Endorsed Version of This Measure
In the May 8, 2013 proposed rule (78 FR 26909 through 26924), we
have proposed to adopt the NQF-endorsed version of the NQF
0678 pressure ulcer measure, with data collection beginning
October 1, 2014 using the revised version of IRF-PAI, for quality
reporting affecting the FY 2017 and subsequent years IRF PPS annual
increase factors. We also proposed to remove the current non-risk
adjusted application of this measure when the revised IRF-PAI is
implemented on October 1, 2014. We noted in the proposed rule that,
until September 30, 2014, IRFs should continue to submit pressure ulcer
data using the IRF-PAI released on October 1, 2012 for the purposes of
data submission requirements for the FY 2015 and FY 2016 IRF PPS
increase factors. Details about our proposed changes to the IRF-PAI and
additional information regarding data submission are discussed in the
proposed rule (78 FR 26909 through 26924).
We invited public comment in response to our proposed removal of
the currently adopted non-risk adjusted application of the Percent of
Residents or Patients with Pressure Ulcers That Are New or Worsened
(short-stay) (NQF 0678) and the adoption of the NQF-endorsed
version of the Percent of Residents or Patients with Pressure Ulcers
That Are New or Worsened (NQF 0678). A summary of the public
comments received and our responses to comments are discussed below in
this final rule.
Comment: Several commenters expressed support for our proposal to
remove the currently adopted non-risk
[[Page 47912]]
adjusted application of the Percent of Residents or Patients with
Pressure Ulcers That Are New or Worsened (short-stay) (NQF
0678) and adopt the NQF endorsed version of the Percent of
Residents or Patients with Pressure Ulcers That Are New or Worsened
(Short Stay) (NQF 0678) for the FY 2017 annual increase
factor. These commenters also expressed general support for the
addition of the risk adjustment factors associated with this measure to
the IRF-PAI.
Response: We appreciate the commenters for their supportive
comments and their feedback for the measure to the IRF-PAI.
Final Decision: After careful consideration of the comments
received, we are finalizing our proposal to adopt the NQF-endorsed
version of the Percent of Residents or Patients with Pressure Ulcers
That Are New or Worsened (short-stay) (NQF 0678) measure
beginning on October 1, 2014, using the revised version of the IRF-PAI.
We are also finalizing our proposal to remove the existing non-risk
adjusted application of NQF 0678 from the IRF QRP effective
October 1, 2014.
Table 12--Summary of Measures Affecting the FY 2017 IRF PPS Annual
Increase Factor and Subsequent Year Increase Factors
------------------------------------------------------------------------
-------------------------------------------------------------------------
Continued Measure Affecting the FY 2015 Annual Increase Factor:
NQF 0138: National Health Safety Network (NHSN)
Catheter-associated Urinary Tract Infection (CAUTI) Outcome
Measure.\+\
New IRF QRP Measure Affecting the FY 2016 IRF PPS Annual Increase
Factor:
NQF 0431: Influenza Vaccination Coverage among
Healthcare Personnel.\+\
New IRF QRP Measures Affecting the FY 2017 IRF PPS Annual Increase
Factor:
All-Cause Unplanned Readmission Measure for 30 Days Post
Discharge from Inpatient Rehabilitation Facilities[supcaret]
NQF 0680: Percent of Residents or Patients Who
Were Assessed and Appropriately Given the Seasonal Influenza
Vaccine (Short-Stay).*
NQF 0678: Percent of Residents or Patients with
Pressure Ulcers That are New or Worsened (Short-Stay).*
------------------------------------------------------------------------
+ Using CDC/NHSN.
* Using the IRF-PAI released October 1, 2014.
[supcaret] Medicare Fee-For-Service claims data.
D. Changes to the IRF-PAI That Are Related to the IRF Quality Reporting
Program
1. General Background
A version of the IRF-PAI has been in use in the IRF setting since
January 1, 2002, when IRFs first began receiving payment under the IRF
PPS. IRFs must submit a completed IRF-PAI for each Medicare Part A, B,
and C patient that is admitted and discharged from the IRF.
The IRF PPS utilizes information from the IRF-PAI to classify
patients into distinct groups based on clinical characteristics and
expected resource needs. Separate payments are calculated for each
group, including the application of case and facility level adjustments
available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/.
In the FY 2014 proposed rule, we proposed to release an updated
version of the IRF-PAI on October 1, 2014 (78 FR 26909-26924) .
Proposed revisions included data elements that will (1) allow for risk
adjustment of the NQF 0678 Percent of Residents or Patients
with Pressure Ulcers That Are New or Worsened (Short-Stay), (2) allow
for voluntary submission of more detailed data collection related to
NQF 0678 Percent of Residents or Patients with Pressure Ulcers
That Are New or Worsened (Short-Stay), and (3) allow for data
collection for NQF 0680 Percent of Residents or Patients Who
Were Assessed and Appropriately Given the Seasonal Influenza Vaccine
(Short-Stay). We also proposed to adopt a new numbering schema for the
IRF-PAI.
What we have proposed includes both mandatory and voluntary
additions to the IRF-PAI. Collection of voluntary data elements by IRFs
will have no impact on measure calculations or on our determination of
whether the IRF has met the reporting requirements under the IRF QRP.
In contrast, failure to complete mandatory data elements may result in
non-compliance with the IRF QRP requirements and subject the facility
to a 2 percentage point reduction in its annual increase factor. We
have provided more details about these items below at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Spotlights-Announcements.html under
``CMS-10036''.
The October 1, 2014 release of the IRF-PAI that we proposed,
inclusive of all the changes that we intend to finalize here, and
information about the IRF-PAI submission process can be found at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/508c-IRF-PAI-2014.pdf. A PRA package for
the revised IRF-PAI discussed here has been submitted for the Office of
Management and Budget's (OMB) review and approval. The PRA package
documents are available for viewing on the CMS PRA Listings Web page
at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS1216518.html?DLPage=1&DLFilter=IRF-PAI&DLSort=1&DLSortDir=descending. The PRA package form number is cms-
10036, and the OMB control number for this PRA package is 0938-0842.
a. Background Related to Collection of Pressure Ulcer Data Elements
Using the IRF-PAI
In the FY 2012 IRF PPS final rule, we finalized a proposal to adopt
an application of the NQF 0678 ``Percent of Residents with
Pressure Ulcers That Are New or Worsened (Short-Stay)'' measure for use
in the IRF QRP, beginning with the IRF PPS annual increase factor for
FY 2014. We also finalized our proposal to collect the data for this
pressure ulcer measure using the IRF-PAI. In order to comply with
section 3004 of the Affordable Care Act requirements, we deleted the
set of outdated pressure ulcer assessment items that were voluntary
quality questions and had been located in the ``Quality Indicator''
section of the IRF-PAI and replaced them with a new set of pressure
ulcer quality measure data items that were designed to capture the data
necessary for the finalized application of NQF 0687. These
items were modeled after the MDS 3.0 items, numbered 48A to 50D, and
changed the status of the pressure ulcer data items from ``voluntary''
to ``mandatory.'' These revisions to the IRF-PAI went into effect on
October 1, 2012.
Since the publication of the FY 2012 final rule (76 FR 47836) we
have received numerous comments about the current version of the IRF-
PAI from IRF providers, provider organizations, and
[[Page 47913]]
advocacy groups. In the CY 2013 OPPS/ASC final rule, we discussed a
number of specific public comments related to pressure ulcer data that
we received in response to the CY 2013 OPPS/ASC IRF proposed rule (77
FR 68506). In that CY 2013 proposed rule, we proposed to update the
application of NQF 0678 that we had previously incorporated
into the IRF QRP by instead incorporating the actual NQF-endorsed
version of this measure (77 FR 45196). NQF 0678 is a risk
adjusted measure. Commenters expressed specific concerns regarding the
ability of the data elements in the IRF-PAI to sufficiently risk-adjust
the measure. We agreed that there were limitations related to the risk
adjustment data items that are on the IRF-PAI that went into effect on
October 1, 2012, impacting the ability to calculate the measure using
all of the risk adjustment related covariates. As a result, the CY 2013
OPPS/ASC final rule adopted an application of 0680 without
risk-adjustment for FY 2015 and subsequent years (77 FR 68507).
In the proposed rule, we noted that in response to the comments and
feedback received in previous rules discussed above, we intended to
propose modifications to the data items in both the admission and
discharge IRF-PAI assessments as discussed below.
2. Revisions to the IRF-PAI To Add Mandatory Risk Adjustment Data Items
for NQF 0678 Percent of Residents or Patients With Pressure
Ulcers That Are New or Worsened (Short-Stay)
In the FY 2014 IRF PPS proposed rule (78 FR 26909-26924), we
proposed to update the current IRF-PAI to include data elements that
are necessary to risk adjust the Percent of Residents or Patients with
Pressure Ulcers That Are New or Worsened (Short-Stay) (NQF
0678). These updates to the IRF-PAI include the addition of
the following indicator boxes to the IRF-PAI admission assessment: (1)
Peripheral Vascular Disease, (2) Peripheral Arterial Disease, and (3)
Diabetes. The additions would be placed in the Quality Indicators
section of the revised IRF-PAI.
We further determined that risk adjustment factors related to
height and weight had inadvertently been left off of the revised
version of the IRF-PAI that became effective on October 1, 2012. We
proposed to add height and weight to the IRF-PAI to correct this
oversight into the ``Medical Information'' section of the IRF-PAI. As a
general rule, we would place all data items related to quality
reporting and quality measures within the Quality Indicator section of
the IRF-PAI. However, the height and weight items have a dual purpose
because they can be used for the calculation of Body Mass Index (BMI),
which is used as one part of the analysis for compliance with the 60
percent rule. Even though the height and weight items are placed in the
``Medical Information'' section of the IRF-PAI, they are also being
added to the IRF-PAI for calculating risk adjustment for the pressure
ulcer measure. Failure to provide height and weight information could
result in a finding of non-compliance with the reporting requirements.
We invited public comment on our proposal to include data elements
required for risk-adjustment of NQF 0678 Percent of Patients
with Pressure Ulcers That Are New or Worsened measure as mandatory data
collection elements in the revised IRF-PAI. Below is a summary of
public comments received for the additional elements required for risk-
adjustment of the pressure ulcer measure, and our responses to these
comments.
Comment: One commenter questioned the use of peripheral artery
disease (PAD), peripheral vascular disease (PVD), and diabetes mellitus
(DM) as risk adjusters for the pressure ulcer quality measure.
Response: Peripheral Arterial Disease, Peripheral Vascular Disease,
and Diabetes are all conditions affecting perfusion and oxygenation,
which are considered to impact risk of pressure ulcer development.
Conditions causing issues of sensory perception (for example,
peripheral neuropathy) or an alteration to intact skin (dry skin,
erythema and other skin alterations) also are considered to impact risk
of pressure ulcer development (Pressure Ulcer Prevention Clinical
Practice Guideline, NPUAP). Additionally, statistical analyses showed
that these factors were found to be significantly associated with the
development of pressure ulcers when risk adjustment models were tested
in a large sample of IRF patients.
Comment: Several commenters requested that CMS consider adding
impairment group as a risk adjuster for the pressure ulcer measure.
Response: When developing the pressure ulcer quality measure, we
reviewed the literature and obtained input from clinicians on which
factors should be tested as potential risk adjustors. Various
measurements of functional status/functional impairment were tested on
a large sample of IRF patients, and were not found to be statistically
significant in the population as a whole. We will continue to analyze
this measure as more data is collected and will consider testing
additional risk adjustors for future iterations of the measure.
Comment: A commenter expressed concern that the adoption of the
NQF-endorsed version of the pressure ulcer measure ``may be too
premature.'' This commenter noted that CMS recently held a technical
expert panel to discuss the potential development of a standardized set
of pressure ulcer measurement items to be used across multiple
healthcare settings (referred to as ``cross-setting''), and therefore,
this commenter suggested that CMS delay implementing the revised
pressure ulcer items.
Response: It was necessary for us to finalize development of the
proposed updates to the pressure ulcer data items for the October 1,
2014 IRF-PAI release prior to work on the cross-setting pressure ulcer
measures because of the significant amount of time required to
implement such a data item set. However, we will continue to work on
improving the data collection efforts to ensure that the most relevant
patient information is obtained.
Final Decision: After careful consideration of the public comments
we received, we are finalizing our proposal to include the additional
risk adjustment elements discussed above to the IRF-PAI for the purpose
of risk-adjustment for NQF 0678 Percent of Residents or
Patients with Pressure Ulcers That Are New or Worsened (Short-Stay).
3. Revisions to the IRF-PAI To Add Voluntary Data Items Related to NQF
0678 Percent of Residents or Patients With Pressure Ulcers
That Are New or Worsened (Short-Stay)
The pressure ulcer measure numerator for the NQF 0678
endorsed version of the ``Percent of Residents or Patients with
Pressure Ulcers That Are New or Worsened (Short-Stay)'' measure looks
at the number of patients with a target assessment during the selected
time window who have one or more Stage 2 through 4 pressure ulcer(s)
that are new or that have worsened compared with the previous
assessment. According to the NQF Web site, in its description of NQF
0678, ``Stage 1 pressure ulcers are excluded from this measure
because recent studies have identified difficulties in objectively
measuring them across different populations.'' The measure numerator
also does not include what is referred to as ``unstageable'' pressure
ulcers, which we describe below. The data that that has been mandatory
for IRFs to report under the IRF QRP are those that met
[[Page 47914]]
the requirements of the application of NQF 0678 that we
finalized in the CY 2013 OPPS/ASC final rule (as incorporated into the
2012 version of the IRF PAI), which reflected the same staging for
pressure ulcers as the NQF-endorsed version of the measure. We have
proposed to include in the 2014 version of the IRF-PAI additional
mandatory data items to accommodate the risk adjustment requirements of
the NQF-endorsed version of this measure.
We have received feedback from providers through a variety of
sources (including a May 2, 2012 in-person training and special open
door forums that occurred on November 29, 2011; April 19, 2012; July
26, 2012; August 16, 2012; September 20, 2012; and October 18, 2012) in
regard to the pressure ulcer items on the IRF-PAI. Additionally, we
have received feedback in the form of questions from IRF providers
submitted to the IRF Quality Reporting Program Helpdesk.
We learned from provider feedback that a majority of IRF providers
want the ability and flexibility to document information about all
stages of pressure ulcers (numerical stages 1 through 4 and pressure
ulcers that are not numerically stageable due to suspected deep tissue
injury, slough and/or eschar, or non-removable devices, known as
unstageable pressure ulcers), in addition to data on the stages of
pressure ulcers required for the quality measure, and that they felt
this extended documentation would allow them to track the evolution of
pressure ulcers. We further learned that many providers felt that it is
important to have a way to document information about healed pressure
ulcers because they wanted us to know about these positive outcomes.
In response to the feedback we received from providers, we proposed
to add voluntary data items to the IRF-PAI Quality Indicators section,
designed to address providers' concerns about the adequacy of current
pressure ulcer data items. As modified, our proposed admission
assessment consists of 2 main topics: (1) Unhealed Pressure Ulcers; and
(2) Pressure Ulcer Risk Conditions. Also, the discharge assessment
consists of 2 main topics: (1) Unhealed Pressure Ulcers; and (2) Healed
Pressure Ulcers. Within each main topic there are sub-topics that
contain a set of questions. The provider is asked to document how many
pressure ulcers, if any, the patient has at each stage upon admission.
We have added new questions that extend beyond stages 2 through 4
pressure ulcers, covering the presence of stage 1 pressure ulcers, as
well as unstageable pressure ulcers that are due to a non-removable
device or dressing, to slough or eschar, or deep tissue injury. We note
that the discharge assessment differs somewhat from the admission
assessment with regard to the pressure ulcer questions. A copy of the
2014 IRF-PAI can be found at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRFPAI.html.
We have added this greater specificity to the pressure ulcer items
to allow providers to document pressure ulcers in more detail. In
describing the inadequacy they perceived in the present pressure ulcer
items, providers described such situations as those in which a patient
is admitted into an IRF with an unstageable pressure ulcer that is a
suspected deep tissue injury (DTI). During the course of the IRF stay
the DTI evolves into a stage 3 and, after several days, worsens to a
stage 4. On the current version of the IRF-PAI, providers have no
ability to document the presence of an unstageable pressure ulcer that
existed when the patient was admitted. Whether or not the IRF believes
there is an unstageable pressure ulcer, the IRF must document that the
patient had no pressure ulcers on the admission assessment. However
later, after the DTI worsens to a stage 3, if the IRF judges from the
nature of the pressure ulcer that it was extremely likely to have been
present at admission, the IRF would have to go back and change their
documentation on the admission assessment to reflect that the patient
actually had a stage 3 pressure ulcer upon admission. Upon discharge,
the IRF would document that the patient has a stage 4 pressure ulcer.
With the new pressure ulcer data items for 2014, the IRF will be able
to document the presence of the unstageable pressure ulcer or suspected
DTI on the admission assessment. The revisions to the IRF-PAI for 2014
will allow the IRF to give a more complete and accurate picture of the
progression of this pressure ulcer when the patient is discharged.
While Stage 1 and unstageable pressure ulcers are not part of the
NQF 0678 endorsed version of the ``Percent of Residents or
Patients with Pressure Ulcers That Are New or Worsened (Short-Stay),''
and are not mandatory, we nonetheless believe that it is appropriate
and important for us to collect this information. As the measure
steward for this measure, CMS would like to gather and analyze data
regarding Stage 1 and unstageable pressure ulcers to help determine if
any modification to the existing measure should be made. This data
could also help us determine if any additional pressure ulcer measures
should be developed. For example, collecting data about Stage 1
pressure ulcers could provide us with information that would allow us
to assess whether these pressure ulcers can now be objectively measured
across different populations.
Additionally, as we have noted above, some pressure ulcers that are
present on admission can become stageable and then worsen to a higher
stage during the IRF stay. Access to data on these kinds of situations
would assist us in determining whether including unstageable and Stage
1 measures in the measure results may be appropriate in the future. We
might accomplish this by expanding the current measure or developing an
entirely new pressure ulcer measure.
We invited public comment on our proposed revisions to the IRF-PAI
of voluntary items related to the staging of pressure ulcers. We
received the following public comments in response to our proposals for
the addition of these voluntary pressure ulcer items to the IRF-PAI.
Comment: Several commenters suggested that stage 1 pressure ulcers
should not be collected on the IRF-PAI.
Response: We obtained feedback from providers on the pressure ulcer
items on the IRF-PAI released in October 2012 during Provider
Trainings, Open Door Forums, and via the Quality Reporting Program
Helpdesk. Based on the feedback we received, we learned that many IRF
providers want the ability to document as much information as possible
about all types of pressure ulcers and feel that this will help them to
better track the evolution of pressure ulcers. Because it would be
useful to us, as well as providers, to obtain complete, accurate
information about the quality of care being provided in IRFs, we
included fields for the documentation of all stages of pressure ulcers,
including Stage 1 and Unstageable pressure ulcers. However, NQF
0678 covers only Stages 2-4 pressure ulcers. Stage 1 pressure
ulcers are not included in the quality measure. If a facility does not
wish to report data on these pressure ulcers, they are under no
obligation to do so.
Comment: Several commenters requested that each IRF-PAI quality
indicator pressure ulcer item be labeled as to whether it is mandatory
or voluntary. Another commenter recommended that the voluntary IRF-PAI
quality indicator pressure ulcer items be segregated from the mandatory
items, or that CMS in some way on the IRF-PAI indicate which of the
items are voluntary.
Response: We have posted on our Web site a detailed matrix that
identifies which data elements will be required,
[[Page 47915]]
and which will be voluntary (available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Spotlights-Announcements.html) and this matrix will also be
incorporated into the final IRF PAI Training Manual which will be
posted on CMS IRF PPS Web site. We do not directly indicate on the IRF-
PAI which items are mandatory versus which items are voluntary. These
designations are subject to change, and although we can address such
changes in rulemaking, the IRF-PAI is only released biannually. Thus,
our ability to change these designations on the IRF-PAI itself is
limited and could lead to provider confusion should these designations
not align with current policy because they have changed during the
interim year when we do not have a new release of the IRF-PAI.
Comment: One commenter suggested that if a pressure ulcer is
discovered after the removal of a ``non-removable device or other
dressing'' during the IRF stay, and there was no documentation of this
wound from the discharging hospital, this should not be counted on the
IRF-PAI due to issues of attribution.
Response: Assessment items collecting data on unstageable pressure
ulcers are voluntary. However, if a numerically staged pressure ulcer
is observed when a non-removable device/dressing is removed, and the
pressure ulcer is still present at the time of discharge, that pressure
ulcer will be reported on the IRF-PAI at discharge. If there were
documentation that the pressure ulcer was present at admission at the
same stage, and it did not worsen to a higher stage during the stay,
then the pressure ulcer would not be considered new or worsened. The
item in the proposed October 1, 2014 IRF-PAI ``Unstageable due to Non-
Removable Device or Dressing'' should be used on admission when there
is documentation of a known pressure ulcer that cannot be fully
visualized and staged due to a non-removable device.
Comment: Several commenters indicated that the IRF-PAI is now too
long and causes undue burden.
Response: We obtained feedback from providers in October of 2012 on
the IRF PAI during Provider Trainings, Open Door Forums, and via the
Quality Reporting Program Helpdesk. Based on the feedback we received,
providers wanted the ability to provide as much information as possible
to truly track the evolution of pressure ulcers, so in order to
accommodate these providers, we are adding voluntary items. However,
only those pressure ulcer items required to calculate the quality
measure NQF 0678, Percent of Patients or Residents with
Pressure Ulcers That Are New or Worsened (Short Stay), are required in
order for providers to avoid a 2 percentage point reduction of the
applicable IRF PPS annual increase factor. Therefore, if a facility
finds completing the additional data items burdensome, it is under no
obligation to do so. Please refer to the 2014 IRF-PAI training manual
for the voluntary/mandatory status of each item.
Comment: One commenter requested that CMS consider capturing the
degree to which a pressure ulcer has healed by discharge.
Response: Pressure ulcer healing and treatment is a complex
clinical issue that is difficult to capture in standardized assessment
items. The IRF-PAI does not record incremental improvement, but instead
captures only condition on admission and discharge, based on staging
pressure ulcers, to avoid undue burden of data collection on
facilities. Possible indicators of healing are numerous and not always
accurate. These include surface area reduction, a common indicator for
tracking the healing of pressure ulcers; however, we do not believe it
is an appropriate data element to include in the IRF-PAI because it is
not the sole determinant of healing. Development of granulation tissue,
decrease in erythema, decrease in exudate, re-epithelialization, etc.,
are also other ways to document pressure ulcer healing. We cannot add
data elements for all possible indicators. Also, many IRF stays are
short, averaging 13 days, and we have no expectation that severe
pressure ulcers will heal completely during this timeframe. If the
patient is admitted with a full thickness pressure ulcer which will
likely not be healed in approximately 13 days, it would simply be noted
in the patient's record as full thickness on discharge. The IRF would
not experience any negative impact from a quality reporting standpoint
in a situation such as this, because this information is not required
for purposes of NQF 0678. Also, from a more general
perspective, quality measures are not designed to track a full set of
details about the progress of any individual patient, but rather to
include just enough information to register a patient's decline or
improvement while in the care of a facility. This kind of assessment
can assist us in monitoring the overall quality of facilities to ensure
patients are receiving high-quality care and to identify facilities
whose practices can be improved.
Final Decision: After giving careful consideration to the public
comments received in response to our proposal to add new voluntary
pressure ulcer items to the IRF-PAI, we are finalizing the proposal to
add the new pressure ulcer items that were posted on the IRF PPS Web
page and as part of the IRF-PAI PRA package.
4. Revisions to the IRF-PAI To Add Mandatory Data Items Related to NQF
0680 Percent of Residents or Patients Who Were Assessed and
Appropriately Given the Seasonal Influenza Vaccine (Short-Stay)
We have proposed to make changes to the IRF-PAI discharge
assessment to include the addition of elements necessary to report data
for the proposed measure, Percent of Residents or Patients Who Were
Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short-
Stay) (NQF 0680). These items will be based on the items from
the MDS 3.0 and LTCH CARE Data Set items.24 25 There are 3
data elements that will be collected in relation to this measure: Two
are used to calculate the measure, and a third is used to ensure
internal consistency and data accuracy. The items are as follows:
---------------------------------------------------------------------------
\24\ Centers for Medicare & Medicaid Services. MDS 3.0 Item
Subsets V1.10.4 for the April 1, 2012 Release. Retrieved from
https://www.cms.gov/NursingHomeQualityInits/30_NHQIMDS30TechnicalInformation.asp.
\25\ The LTCH CARE Data Set Version 2.00, the data collection
instrument for the submission of the Percent of Residents or
Patients with Pressure Ulcers That are New or Worsened (Short-Stay)
measure and the Percent of Residents or Patients Who Were Assessed
and Appropriately Given the Seasonal Influenza Vaccine (Short-Stay)
measure, is currently under review by the Office of Management and
Budget (OMB) in accordance with the Paperwork Reduction Act (PRA)
https://www.gpo.gov/fdsys/pkg/FR-2013-02-01/pdf/2013-02155.pdf. The
LTCH CARE Data Set Version 1.01 was approved on April 24, 2012 by
OMB in accordance with the PRA. The OMB Control Number is 0938-1163.
Expiration Date April 30, 2013.
---------------------------------------------------------------------------
Did the patient receive the influenza vaccine in this
facility for this year's influenza vaccination season?
Date influenza vaccine was received, and
If influenza vaccine not received, state reason.
These items and questions allow the IRF to report if and when an
influenza vaccine was given at the facility. They also allow the IRF to
indicate why a vaccine was not given if that is the case. Further
details on the specifications and data elements for this measure are
available in the MDS 3.0 QM User's Manual available on our Web site at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIQualityMeasures.html. Measure
specifications are located in the download titled: MDS 3.0 QM User's
Manual V6.0. Measure information is
[[Page 47916]]
also available at https://www.qualityforum.org/QPS/0680.
In the proposed rule, we invited public comment on our proposed
revisions to the IRF-PAI related to NQF 0680 Percent of
Residents or Patients Who Were Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay). The comments we received were
related to our proposal to adopt the measure itself, and not on how we
were proposing to modify the IRF-PAI. For a summary of comments and
responses on this issue, please see section XIV.3.b. of this final
rule.
Final Decision: After careful consideration of the public comments
we received, we are finalizing our proposal to modify the IRF-PAI
discharge item set to add the 3 data elements for collecting data for
NQF 0680.
5. Revisions to the IRF-PAI Related to Numbering of Quality Indicator
Items
In the revised IRF-PAI, we include changes in the numbering scheme
used in the Quality Indicator section of the IRF-PAI from a
``consecutive numbering scheme'' for numbering assessment items to a
numbering scheme that allows greater flexibility for item removal and
insertion. Problems arise with a consecutive numbering scheme when
items are removed or new ones are inserted because this changes the
numbers of some or all of the items around them. Other CMS post-acute
care data collection vehicles, such as the MDS 3.0 and the LTCH CARE
Data Set, have adopted a more flexible numbering schema that allows
insertion or removal of items without requiring renumbering of the
remaining items. We proposed to adopt a similar numbering schema in the
revised IRF-PAI. A less flexible numbering system that necessitates
renumbering items on the IRF-PAI in the event of such changes will
result in a given item number having very different meanings on
different versions of the IRF-PAI item set.
For more details about our plans for changes to the IRF-PAI, see
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRFPAI.html.
In the May 8, 2013 proposed rule, we invited public comments about
our proposal to change the numbering scheme used in the quality
indicator section of the IRF-PAI. A summary of the public comments
received and our responses to comments are discussed below.
Comment: We did not receive any comments in response to our
proposal to change the type of numbering used on the quality indicator
section of the IRF-PAI from a consecutive scheme to a numbering scheme
similar to that used in the MDS 3.0. We did, however, receive comments
requesting that page numbers be added to the IRF-PAI. The commenters
suggested that because this document was being increased from 3 to 9
pages in length as a result of the proposed changes to the Quality
Indicator section of the IRF-PAI then the page numbering should be
added. Another commenter requested that page numbers be added to the
IRF-PAI because ``numbering the IRF-PAI pages will help keep it in
correct order, since it is filed in the medical record.''
Response: We agree with the commenters that adding page numbering
to the IRF-PAI can assist IRFs in keeping the document in correct
order. We also acknowledge that the proposed changes to the Quality
Indicator section of the IRF-PAI will significantly increase the length
of this document.
Final Decision: After careful consideration of the public comments
we received, we are finalizing our proposal to adopt a flexible
numbering scheme (similar to that used in MDS 3.0) into the Quality
Indicator section of the IRF-PAI. In addition, we will add general page
numbering to the IRF-PAI document.
E. Change in Data Collection and Submission Periods for Future Program
Years
The FY 2012 final rule (76 FR 47836) included an initial framework
for the IRF QRP. In that rule we also finalized the initial quality
measures to be used in the IRF QRP, stated how data for these measures
would to be collected, and selected the time periods for the data
collection and reporting of the quality data.
The FY 2012 final rule (76 FR 47836) also finalized the initial IRF
QRP data reporting cycle, affecting the FY 2014 annual increase factor,
as beginning on October 1, 2012 and ending on December 31, 2012.
Beginning in 2013 for the FY 2015 annual increase factor, and for
subsequent year annual increase factors, we finalized that quality
reporting cycles would be based on a full calendar year (CY) cycle (76
FR 47879).
When there are new measures added to the quality reporting program
that will be collected on the IRF-PAI, that data collection instrument
must be updated accordingly. The next update to the IRF- PAI will take
place on October 1, 2014. Under current policy, the IRF QRP data
collection cycle for the FY 2016 annual increase factor will not begin
until January 1, 2014.
In the FY 2014 proposed rule, we proposed to change the IRF-PAI
data collection periods for the FY 2016 and FY 2017 annual increase
factors in order to align with the release of the new version of the
IRF-PAI on October 1, 2014. We have also proposed to shorten the data
collection period impacting the FY 2016 IRF PPS annual increase factor
to 9 months, so that the FY 2017 reporting periods can begin on October
1, 2014 using the new version of the IRF-PAI. Under this proposal, the
next data collection period would run from January 1, 2014 to September
30, 2014 and affect the IRF PPS annual increase factor for FY 2016.
We further proposed to start fiscal year data collection periods
beginning on October 1, 2014, and data collected for discharges during
October 1, 2014 to September 30, 2015 will affect the FY 2017 IRF PPS
annual increase factor. In addition, we proposed that data collection
will continue on FY cycles unless there is an event that requires that
this cycle be amended. We noted that, in the event the established
cycles must be changed, we will make this apparent to the public and
follow all necessary processes to make the change. Finalizing these
proposals will result in having 2 separate data collection and
submission schedules for IRF-PAI and NHSN based measures. We provide
more details on this distinction below.
We invited public comment on our proposal to alter the IRF-PAI data
collection periods impacting the FY 2016 and FY 2017 increase factors
in a way that aligns with the release of the next version of the IRF-
PAI instrument. A summary of the public comments received and our
responses to comments are discussed below.
Comment: Several commenters expressed support for this proposal. We
did not receive any comments that included objections to our proposal
to change the data collection and submission timeframe for data
collected using the IRF-PAI from a calendar year basis to a fiscal year
basis, beginning on October 1, 2014. Likewise, no commenters objected
to our continuing collection of NHSN data on a calendar year basis.
Response: We thank those commenters for their support of the
proposed changes to the data collection and submission cycle for data
collected using the IRF-PAI from a calendar to a fiscal year basis.
Comment: Several commenters expressed their support for our
proposal to continue data collection and submission of NHSN measures
data on a calendar year basis beginning on October 1, 2014 with the
exception of
[[Page 47917]]
the Influenza Vaccination Among Healthcare Personnel Measure (NQF
0431). These commenters expressed an opinion that IRF units
within acute care hospitals should be permitted to attest that their
health care personnel flu vaccination measure data is reported through
the acute care hospital's reporting, thereby automatically receiving
credit for reporting in the IRF QRP.
Response: We thank those commenters for their support of our
proposal to continue to report data to NHSN on a calendar year. We do
not agree, however, that IRF units located within IPPS hospitals should
be permitted to attest to the submission of (NQF 0431)
Influenza Vaccination among Healthcare Personnel measure data as part
of the IPPS data. We will require all IRFs to report data for this
measure. For a full discussion of this specific issue, as well as
details about this measure, see section XIV.3.C.2 above ``IRF QRP
Measure #1: Influenza Vaccination Coverage among Healthcare Personnel
(NQF #0431)''.
Final Decision: After careful consideration of the public comments
received, we are finalizing our proposal to change the data collection
timeframe for data submitted via the IRF-PAI to a fiscal year basis
beginning on October 1, 2014, and to continue data collection of data
that is reported via NHSN on a calendar year basis.
1. Implementation of Data Submission Deadlines for the IRF QRP
In the FY 2012 IRF PPS final rule we stated that details regarding
data submission and reporting requirements would be posted on the CMS
Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/ no later than
January 31, 2012 (76 FR 47879). Further data submission details for the
IRF QRP were posted on the CMS IRF QRP Web site on January 31, 2012, as
promised. In addition, data submission details were disseminated to
IRFs at various times from January 31, 2012 to December 31, 2012,
through an in-person training held on May 2, 2012, Open Door Forums,
list-serve announcements, IRF QRP Web page postings and responses to
IRF QRP Helpdesk inquiries. In these communications, we announced that
the final data submission deadline for the IRF QRP would be May 15th
for all measures finalized for the FY 2014 annual increase factor and
each subsequent years annual increase factor.
We realize the value in providing clear submission deadlines for
the IRF QRP and we believe that we should provide deadlines that
clearly distinguish between data submitted using the NHSN and data
submitted using the IRF-PAI. Further, it is important to have distinct
deadlines at which point data submitted afterward, including data
modifications and corrections, could not be used for reporting or IRF
PPS annual increase factor determinations. For purposes of the FY 2016
and subsequent year IRF PPS annual increase factors, and for the
purposes of applying quarterly deadlines for public reporting purposes,
we proposed the inclusion of quarterly data submission deadlines in
addition to the previously finalized deadlines. We believe that clear
submission deadlines this will ensure timely submission of data.
2. Quarterly Timelines for Submitting Data Using the IRF-PAI
For the purposes of submitting quality data using the IRF-PAI for
the IRF QRP, we have proposed new quarterly timeframes described below
that we believe will provide sufficient time for IRFs to meet quality
reporting requirements and allow us to harmonize IRF QRP data
submission deadlines with the LTCHQR Program and Hospital IQR.
Beginning with data collection and reporting impacting the FY 2016
annual increase factor, we proposed that IRFs follow the deadlines
presented in the tables below to complete submission of data for each
quarter. For each quarter outlined in the tables below during which
IRFs are required to collect data, we proposed a final deadline
occurring approximately 135 days (or approximately 4 and \1/2\ months)
after the end of each quarter by which all data collected during that
quarter must be submitted. We believe that this is a reasonable amount
of time to allow IRFs to submit data and make any necessary
corrections. We have summarized these deadlines in the tables below.
Table 13--Timelines for Submission of IRF QRP Program Quality Data Using IRF-PAI * for FY 2016 IRF PPS Annual
Increase Factor \+\: Application of NQF 0678 Percent of Residents or Patients With Pressure Ulcers That
Are New or Worsened (Short-Stay)
----------------------------------------------------------------------------------------------------------------
IRF-PAI Data submission
Quarter IRF-PAI Data collection period deadline for corrections
of the IRF QRP
----------------------------------------------------------------------------------------------------------------
FY 2016 Annual Increase Factor
----------------------------------------------------------------------------------------------------------------
Quarter 1........................... January 1, 2014-March 31, 2014.................. August 15, 2014.
Quarter 2........................... April 1, 2014-June 30, 2014..................... November 15, 2014.
Quarter 3........................... July 1, 2014-September 30, 2014................. February 15, 2015.
----------------------------------------------------------------------------------------------------------------
* Using October 1, 2012 release of IRF-PAI.
\+\ FY 2016 APU determination is based on 3 quarters of data submission for the pressure ulcer measure.
Table 14--Timelines for Submission of IRF QRP Program Quality Data Using IRF-PAI * for FY 2017 IRF PPS Annual
Increase Factor: NQF 0678 Percent of Residents or Patients With Pressure Ulcers That Are New or
Worsened (Short-Stay), and NQF 0680 Percent of Residents or Patients Who Were Assessed and
Appropriately Given the Seasonal Influenza Vaccine (Short-Stay)
----------------------------------------------------------------------------------------------------------------
IRF-PAI Data submission
Quarter IRF-PAI Data collection period deadline for corrections
of the IRF QRP
----------------------------------------------------------------------------------------------------------------
FY 2017 Annual Increase Factor
----------------------------------------------------------------------------------------------------------------
Quarter 1........................... October 1, 2014-December 31, 2014............... May 15, 2015.
[[Page 47918]]
Quarter 2........................... January 1, 2015-March 31, 2015.................. August 15, 2015.
Quarter 3........................... April 1, 2015-June 30, 2015..................... November 15, 2015.
Quarter 4........................... July 1, 2015-September 30, 2015................. February 15, 2016.
----------------------------------------------------------------------------------------------------------------
* Using October 1, 2014 release of IRF-PAI.
3. Quarterly Submission Timelines of Data Reported Using NHSN
In the FY 2014 proposed rule (78 FR 26909 through 26924), we
proposed that the IRF QRP align its deadlines for submitting of quality
data via the NHSN with the established deadlines set forth in the
Hospital IQR and LTCHQR Programs. We noted that the CDC recommends that
a facility report Healthcare Acquired Infection (HAI) events such as
CAUTI as close to the time of the event as possible, and certainly
within 30 days after the event. We agree with the CDC's recommendations
and therefore are requiring that IRFs report CAUTI events, even null
events (months without CAUTIs) within 30 days (on a monthly level)
after each event using the NHSN.
We are finalizing our proposal to continue the calendar year basis
of reporting CAUTI, using quarterly deadlines as established by the
Hospital IQR program for all events that occur during each quarter.
Final submission deadlines for data collected through the NHSN are
shown in the tables below.
Table 15--Timelines for Submission of IRF QRP Program Quality Data Using CDC/NSHN for FY 2016 and FY 2017 IRF
PPS Annual Increase Factor: National Health Safety Network (NHSN) Catheter-Associated Urinary Tract Infection
(CAUTI) Outcome Measure
----------------------------------------------------------------------------------------------------------------
CDC/NHSN Data submission
Quarter CDC/NHSN Data collection period deadline
----------------------------------------------------------------------------------------------------------------
FY 2016 Annual Increase Factor
----------------------------------------------------------------------------------------------------------------
Quarter 1........................... January 1, 2014-March 31, 2014.................. August 15, 2014.
Quarter 2........................... April 1, 2014-June 30, 2014..................... November 15, 2014.
Quarter 3........................... July 1, 2014-September 30, 2014................. February 15, 2015.
Quarter 4........................... October 1, 2014-December 31, 2014............... May 15, 2015.
----------------------------------------------------------------------------------------------------------------
FY 2017 Annual Increase Factor
----------------------------------------------------------------------------------------------------------------
Quarter 1........................... January 1, 2015-March 31, 2015.................. August 15, 2015.
Quarter 2........................... April 1, 2015-June 30, 2015..................... November 15, 2015.
Quarter 3........................... July 1, 2015-September 30, 2015................. February 15, 2016.
Quarter 4........................... October 1, 2015-December 31, 2015............... May 15, 2016.
----------------------------------------------------------------------------------------------------------------
Further, we proposed to apply to IRF QRP the same deadlines
established for the reporting of the Influenza Vaccination Coverage
Among Health Personnel (NQF 0431) measure in the Hospital IQR
Program and proposed in the LTCH QRP.
Table 16--Timelines For Submission of IRF QRP Program Quality Data Using
CDC/NSHN for FY 2016 and FY 2017 IRF PPS Annual Increase Factor: NQF
0431 Influenza Vaccination Coverage Among Healthcare Personnel
------------------------------------------------------------------------
CDC/NHSN Data submission
Data collection timeframe deadline
------------------------------------------------------------------------
FY 2016 Annual Increase Factor
------------------------------------------------------------------------
October 1, 2014 (or when the influenza May 15, 2015.
vaccine becomes available)-March 31, 2015.
------------------------------------------------------------------------
FY 2017 Annual Increase Factor
------------------------------------------------------------------------
October 1, 2015 (or when the influenza May 15, 2016.
vaccine becomes available)-March 31, 2016.
------------------------------------------------------------------------
We invited public comment on the proposals made in the proposed
rule regarding data submission quarterly and final deadlines for the
purposes of reporting data using the IRF-PAI and for the purposes of
reporting data using the NHSN. The following are comments received in
response to these proposals and our response to these comments.
[[Page 47919]]
Comment: A few comments expressed support for our proposal to apply
quarterly reporting deadlines to both the measures reported using the
IRF-PAI on a fiscal year basis and to the measures reported to the CDC
via NHSN on a calendar year basis.
Response: We thank the commenters for their supportive comments on
the IRF-PAI measure on a fiscal year basis.
Final Decision: After careful consideration of the public comments
we received, we are finalizing our proposal to apply quarterly
deadlines to both the measures reported using the IRF-PAI on a fiscal
year basis and to the measures reported to the CDC via NHSN on a
calendar year basis.
F. Reconsideration and Appeals Process
In the proposed rule (78 FR 26909 through 26921) we provided
details pertaining to a reconsideration process, and the mechanisms
related to provider requests for reconsideration of their annual
increase factor, such as filing requests, required content, supporting
documentation, and mechanisms of notification and final determinations
on the IRF QRP Web site this spring at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/. We also invited public comment on the proposed
procedures for reconsideration and appeals. We received the following
public comments related to our discussion of the reconsideration
process in the proposed rule:
Comment: Many commenters expressed support of CMS' proposed IRF QRP
reconsideration and appeals process. Further, one commenter encouraged
CMS to mirror the processes used in the Hospital IQR Program and the
Hospital Outpatient Quality Reporting (OQR) Program when developing
reconsideration and appeals and for the IRF QRP.
Response: We thank the commenters for their support for the
inclusion of reconsideration and appeals processes in the IRF QRP. It
is our goal to align our reconsideration and appeals process and
policies with those of existing quality reporting programs, such as
Hospital IQR Program and the Hospital Outpatient Quality Reporting
Program, to the extent appropriate for the IRF QRP. We greatly
appreciate the commenters' views on the reconsideration process, and
will consider all of these comments for future rulemaking and program
development.
Comment: One commenter expressed concern that CMS did not provide
procedural details of the reconsideration process through rulemaking
and encouraged CMS to ensure that sufficient outreach and education is
conducted in a timely manner regarding these processes.
Response: We thank the commenter for the comments. We established a
Web site that provides procedural details for the FY 2014 IRF QRP
reconsideration process. This information is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Reconsideration-and-Disaster-Waiver-Requests.html. We noted in the FY 2014 proposed rule (78 FR 26909
through 26921) that we developed this Web site as a resource to inform
providers on how to seek reconsideration of any decision of non-
compliance for the FY 2014 annual increase factor, and the necessary
steps to do so. We provided a process for reconsideration should IRFs
choose to avail themselves of it. In the FY 2014 proposed rule (78 FR
26909 through 26921), we stated that IRFs must first apply for
reconsideration through CMS prior to appealing our initial finding of
non-compliance to the PRRB. In light of a commenter's concern that CMS
did not provide procedural details of the reconsideration process
through rulemaking and concern that CMS ensure that sufficient outreach
and education are available, we have decided to continue with an IRF
QRP reconsideration process that is voluntary for the time being in
order to fully address these concerns. We are therefore only
recommending that IRFs use the reconsideration process prior to
appealing to the PRRB. We note that the agency has had good success
under the Hospital IQR program with a process that is very similar to
the one we proposed for the IRF QR. From the provider perspective, it
allows for the opportunity to resolve issues early in the process when
we have dedicated resources to considering all reconsideration requests
before payment changes are applied to an IRF's annual payment update.
From CMS' perspective, it decreases the number of appeals presented to
the PRRB, which reviews cases for all quality reporting programs,
allowing for more efficient operations at the appeals level.
Because we have been aware that providers should be able to request
a reconsideration of their annual increase factor if their
circumstances warrant it as soon as possible, we provided details
pertaining to the voluntary reconsideration process, and the mechanisms
related to provider requests for reconsiderations of their annual
increase factor, such as filing requests, required content, supporting
documentation, and mechanisms of notification and final determinations
on the IRF QRP Web site in spring 2013 prior to any IRF's need for
information on the CMS reconsideration process for the FY 2014 annual
increase factor and subsequent years annual increase factors at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting. CMS' subregulatory approach to the
FY 2014 reconsideration process was necessary, as any other form of the
reconsideration process that we might propose and finalize in this rule
would not be final and in effect until October 1, 2013. This would have
the effect of proposing and finalizing a FY 2014 process for
reconsiderations that should already be completed. We note that we are
finalizing the policy that this subregulatory approach to the
reconsideration process will remain in effect until we can propose and
finalize a regulatory version of the reconsideration process in future
rulemaking.
As part of the voluntary process, IRFs that are non-compliant with
the reporting requirements during a given reporting cycle will be
notified of that finding. The purpose of this notification is to put
the IRF on notice of the following: (1) That the IRF has been
identified as being non-compliant with the IRF QRP's reporting
requirements for the reporting cycle in question; (2) that the IRF will
be scheduled to receive a reduction in the amount of two percentage
points to the annual payment update for the upcoming fiscal year; (3)
that the IRF may file a request for reconsideration if they believe
that the finding of non-compliance is erroneous, or that if they were
non-compliant, they have a valid and justifiable excuse for this non-
compliance; and (4) that the IRF must follow a defined process on how
to file a request for reconsideration, which will be described in the
notification.
Upon the conclusion of our review of each request for
reconsideration, we will render a decision. We may reverse our initial
finding of noncompliance if: (1) The IRF provides proof of full
compliance with all requirements during the reporting period; or (2)
the IRF provides adequate proof of a valid or justifiable excuse for
non-compliance if the IRF was not able to comply with requirements
during the reporting period. We will uphold our initial finding of
noncompliance if the IRF cannot show any justification for
noncompliance.
[[Page 47920]]
G. Policy for Granting a Waiver of the IRF QRP Data Submission
Requirements in Case of Disaster or Extraordinary Circumstances
Our experience with other quality reporting programs has shown that
there are times when providers are unable to submit quality data due to
the occurrence of extraordinary circumstances beyond their control (for
example, natural or man-made disasters). We define 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 or impact multiple
structures or be isolated and impact a single site only.
In certain instances of either natural or man-made disasters, an
IRF may have the ability to conduct a full patient assessment, and
record and save the associated data either during or before the
occurrence of an extraordinary event. In this case, the extraordinary
event has not caused the facility's data files to be destroyed, but it
could hinder the IRF's ability to meet the quality reporting program's
data submission deadlines. In this scenario, the IRF would potentially
have the ability to report the data at a later date, after the
emergency circumstances have subsided. In such cases, a temporary
waiver of the IRF duty to report quality measure data may be
appropriate.
In other circumstances of natural or man-made disaster, an IRF may
not have had the ability to conduct a full patient assessment, and
record and save the associated data before the occurrence of an
extraordinary event. In such a scenario, the facility does not have
data to submit to CMS as a result of the extraordinary event. We
believe that it is appropriate, in these situations, to grant a full
waiver of the reporting requirements.
It is our goal not to penalize IRF providers in these circumstances
or to unduly increase their burden during these times. Therefore, we
proposed a process, for payment year 2015 and subsequent years, for IRF
providers to request and for us to grant waivers with respect to the
reporting of quality data when there are extraordinary circumstances
beyond the control of the provider. When a waiver is granted, an IRF
will not incur payment reduction penalties for failure to comply with
the requirements of the IRF QRP.
In the FY 2014 proposed rule (78 FR 26909 through 26921), we
proposed to establish a disaster waiver process, in which IRFs that
have experienced a disaster can request a waiver of their quality
reporting responsibilities for purposes of payment year 2015 and
subsequent payment years. We proposed that the IRF may request a waiver
for one or more quarters by submitting a written request to CMS. We
also proposed that should IRFs compose a letter to CMS that documents
the waiver request, with the information described below, and submit
the letter to CMS via email to the IRF Help Desk at
IRFQRPReconsiderations@cms.hhs.gov. IRFs that have filed a request for
an IRF QRP disaster waiver with an IRF-PAI waiver request using the
procedure that is described under our regulations at 42 CFR Sec.
412.614 can indicate this in their letter to CMS for their request for
a waiver for quality reporting purposes.\26\
---------------------------------------------------------------------------
\26\ https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol2/pdf/CFR-2011-title42-vol2-sec412-614.pdf.
---------------------------------------------------------------------------
Note that the subject of the email must read ``Disaster Waiver
Request'' and the letter must contain the following information:
IRF CCN;
IRF 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);
IRF's reason for requesting a waiver;
Evidence of the impact of extraordinary circumstances,
including but not limited to photographs, newspaper and other media
articles; and
A date when the IRF believes that it will again be able to
submit IRF QRP data and a justification for the proposed date.
We proposed that the letter documenting the disaster waiver request
be signed by the IRF's CEO, and must be submitted within 30 days of the
date that the extraordinary circumstances occurred. Following receipt
of the letter, we would: (1) Provide a written acknowledgement, using
the contact information provided in the letter, to the CEO or
designated contact person, notifying them that the request has been
received, and (2) after CMS has made a decision as to whether to grant
the waiver request, provide a formal response to the CEO, or designated
contact person notifying them of our decision.
This policy does not preclude us from granting waivers to IRFs 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 a waiver to IRFs in a
region or locale, we propose to communicate this decision through
routine communication channels to IRFs and vendors, including but not
limited to issuing memos, emails, and notices on https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/.
In the proposed rule, we invited public comment on our proposed
disaster waiver process. A summary of the public comments received and
our responses to comments are discussed below.
Comment: Several commenters stated that they support the IRF QRP
disaster waiver policy and ``applaud the agency for recognizing the
impact of natural disasters and other extenuating circumstances on the
ability of IRFs to collect and report quality data.''
Response: We appreciate the commenters' support and recognition of
our efforts to plan for various types of emergency situations that can
impact an IRF's ability to report quality data.
Final Decision: After careful consideration of the public comments
received, we are finalizing the IRF QRP disaster/extraordinary
circumstances waiver and appeals processes as proposed.
H. Public Display of Data Quality Measures for the IRF QRP Program
Under section 1886(j)(7)(E) of the Act, the Secretary is required
to establish procedures for making data submitted under the IRF QRP
available to the public. Section 1886(j)(7)(E) of the Act also requires
procedures to ensure that each IRF provider has the opportunity to
review the data that is to be made public with respect to its facility,
prior to such data being made public. Section 1886(j)(7)(E) of the Act
requires CMS to report quality measures that relate to services
furnished in IRFs on CMS' Web site.
Currently, the Agency is developing plans regarding the
implementation of these provisions. We appreciate the need for
transparency in the processes and procedures that will be implemented
to allow for the public reporting of the IRF QRP data and to afford
providers the opportunity to preview that data before it is made
public. At this time, we have not
[[Page 47921]]
established procedures or timelines for public reporting of data, but
we intend to include related proposals in future rule making.
Comment: Several commenters urged CMS to convene stakeholders to
inform this process prior to rulemaking. One commenter strongly
encouraged CMS to display the most current performance data for public
reporting of IRF QRP data.
Response: We appreciate the commenters for their feedback. We
appreciate the need to ensure that the data made publicly available is
easily understood by all stakeholders, including providers and
consumers. At this time, we are working to establish procedures for
public reporting, including procedures that provide the opportunity for
IRFs to review their data before it is made public, and will propose
such procedures through future rulemaking after allowing stakeholders
the opportunity to submit input.
We thank the commenters for the input and suggestions, and we will
consider them as we develop proposals for public reporting of quality
measures in future rulemaking.
I. Method for Applying the Reduction to the FY 2014 IRF Increase Factor
for IRFs That Fail To Meet the Quality Reporting Requirements
As previously noted, section 1886(j)(7)(A)(i) of the Act requires
application of a 2 percentage point reduction of the applicable market
basket increase factor for IRFs that fail to comply with the quality
data submission requirements. FY 2014 is to be the first year that the
mandated reduction will be applied for IRFs that failed to comply with
the data submission requirements during the data collection period
October 1, 2012 through December 31, 2012. Thus, in compliance with
1886(j)(7)(A)(i) of the Act, we will apply a 2 percentage point
reduction to the applicable FY 2014 market basket increase factor (1.8
percent) in calculating an adjusted FY 2014 standard payment conversion
factor to apply to payments for only those IRFs that failed to comply
with the data submission requirements. As noted previously, application
of the 2 percentage point reduction may result in an update that is
less than 0.0 for a fiscal year and in payment rates for a fiscal year
being less than such payment rates for the preceding fiscal year. Also,
reporting-based reductions to the market basket increase factor will
not be cumulative; they will only apply for the FY involved. Table 17
shows the calculation of the adjusted FY 2014 standard payment
conversion factor that will be used to compute IRF PPS payment rates
for any IRF that failed to meet the quality reporting requirements for
the period from October 1, 2012 through December 31, 2012.
Table 17--Calculations To Determine the Adjusted FY 2014 Standard
Payment Conversion Factor for IRFs That Failed To Meet the Quality
Reporting Requirement
------------------------------------------------------------------------
Explanation for Adjustment Calculations
------------------------------------------------------------------------
Standard Payment Conversion Factor for FY 2013....... ... $14,343
Adjusted Market Basket Increase Factor for FY 2014 x 0.99800
(2.6 percent), reduced by 0.3 percentage point in
accordance with sections 1886(j)(3)(C) and (D) of
the Act and a 0.5 percentage point reduction for the
productivity adjustment as required by section
1886(j)(3)(C)(ii)(I) of the Act, further reduced by
2 percentage points for IRFs that failed to meet the
quality reporting requirement.......................
Budget Neutrality Factor for the Wage Index and Labor- x 1.0010
Related Share.......................................
Budget Neutrality Factor for the Revisions to the CMG x 1.0000
Relative Weights....................................
Budget Neutrality Factor for the Update to the Rural x 1.0025
Adjustment Factor...................................
Budget Neutrality Factor for the Update to the LIP x 1.0171
Adjustment Factor...................................
Budget Neutrality Factor for the Update to the x 0.9962
Teaching Status Adjustment Factor...................
Adjusted FY 2014 Standard Payment Conversion Factor.. = $14,555
------------------------------------------------------------------------
XV. Miscellaneous Comments
Comment: Several commenters requested that CMS use the most recent
three years of data and the first year of data collected under ICD-10
to review and update the list of comorbidities used to determine the
tier payments to ensure that the tier list reflects all conditions that
contribute significantly to IRF costs of care. One commenter also
suggested that CMS re-examine the omission from this list of certain
comorbidities that are considered preventable and might lead to
perverse incentives for the IRF to undertreat these conditions.
Response: We appreciate the commenters' suggestions, and will
consider these suggestions for future analyses.
Comment: One commenter suggested that CMS revise the IRF coverage
requirements that are described in chapter 1, section 110 of the
Medicare Benefit Policy Manual (Pub. L. 100-02) to allow recreational
therapy services to count, on a limited basis, towards the intensive
rehabilitation therapy requirement in IRFs when the medical necessity
is well-documented by the rehabilitation physician in the medical
record and is ordered by the rehabilitation physician as part of the
overall plan of care for the patient.
Response: As we did not propose any changes to the IRF coverage
requirements in Sec. 412.622(a)(3), (4), and (5) that would affect any
of the requirements described in chapter 1, section 110 of the Medicare
Benefit Policy Manual (Pub. L. 100-02), this comment is outside the
scope of the proposed rule. However, as we have indicated previously in
the FY 2012 IRF PPS final rule (76 FR 47836 at 47883), we do not
believe that recreational therapy services should replace the provision
of the 4 core skilled therapy services (physical therapy, occupational
therapy, speech-language therapy, and prosthetics/orthotics). Thus, we
believe it should be left to each individual IRF to determine whether
offering recreational therapy is the best way to achieve the desired
patient care outcomes. As we have stated previously, recreational
therapy is a covered service in IRFs when the medical necessity is
well-documented by the rehabilitation physician in the medical record
and is ordered by the rehabilitation physician as part of the overall
plan of care for the patient. Recreational therapy may be offered as an
additional service above and beyond the core skilled therapy services
used to demonstrate the provision of an intensive rehabilitation
therapy program, but may not replace one of these therapies.
Comment: One commenter requested that we consider a new model of
payment for post-acute care services, such as the Continuing Care
Hospital (CCH) model, that would pay based on the needs of the patient
rather than the setting in which the care is provided.
[[Page 47922]]
This commenter urged us to pilot test the CCH idea.
Response: As we did not propose any new payment models for post-
acute care services in the FY 2014 IRF PPS proposed rule (78 FR 26880),
this comment is outside the scope of this rule. However, we appreciate
the commenter's suggestions, and we note that on May 15, 2013, CMS
announced a second round of Health Care Innovation Awards. Under this
announcement, we will spend up to $1 billion for awards and evaluation
of projects from across the country that test new payment and service
delivery models that will deliver better care and lower costs for
Medicare, Medicaid, and Children's Health Insurance Program (CHIP)
enrollees. In addition, we commenced the Bundled Payments for Care
Improvement Initiative, whereby organizations will enter into payment
arrangements that include financial and performance accountability for
episodes of care. These models may lead to higher quality, more
coordinated care at a lower cost to Medicare. In one of the model
designs being tested (referred to as ``Model 3'' at https://innovation.cms.gov/initiatives/BPCI-Model-3), the episode of care will
be triggered by an acute care hospital stay and will begin at
initiation of post-acute care services with a participating skilled
nursing facility, inpatient rehabilitation facility, long-term care
hospital or home health agency.
Comment: Several commenters requested that we use the electronic
signature guidelines provided in the Medicare Program Integrity Manual
to allow the use of electronic signatures for all required
documentation, including for the rehabilitation physician's review and
concurrence with the preadmission screening requirements under the IRF
coverage requirements in 412.622(a)(3)(i).
Response: As we did not propose any changes to the regulations in
Sec. 412.622(a)(3)(i) in the May 8, 2013 proposed rule (78 FR 26880),
this comment in outside the scope of this final rule. However, we have
provided specific guidance on the use of electronic signatures for
documentation of the rehabilitation physician's review and concurrence
with the IRF preadmission screening requirements, which can be
downloaded from the IRF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/ElecSysClar.pdf.
XVI. Provisions of the Final Regulations
In this final rule, we are adopting the provisions set forth in the
FY 2014 IRF PPS proposed rule (78 FR 26880), except as noted elsewhere
in the preamble. Specifically:
A. Payment Provision Changes
We will update the FY 2014 IRF PPS relative weights and
average length of stay values using the most current and complete
Medicare claims and cost report data in a budget-neutral manner, as
discussed in section IV of this final rule.
We will update the FY 2014 IRF PPS facility-level
adjustment factors, using the most current and complete Medicare claims
and cost report data with an enhanced estimation methodology, in a
budget-neutral manner, as discussed in section V of this final rule.
We will update the FY 2014 IRF PPS payment rates by the
market basket increase factor, based upon the most current data
available, with a 0.3 percentage point reduction as required by
sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(iii) of the Act and a
productivity adjustment required by section 1886(j)(3)(C)(ii)(I) of the
Act, as described in section VI of this final rule.
We will indicate the Secretary's Final Recommendation for
updating IRF PPS payments for FY 2014, in accordance with the statutory
requirements, as described in section VI of this final rule.
We will update the FY 2014 IRF PPS payment rates by the FY
2014 wage index and the labor-related share in a budget-neutral manner,
as discussed in section VI of this final rule.
We will calculate the final IRF Standard Payment
Conversion Factor for FY 2014, as discussed in section VI of this final
rule.
We will update the outlier threshold amount for FY 2014,
as discussed in section VII of this final rule.
We will update the cost-to-charge ratio (CCR) ceiling and
urban/rural average CCRs for FY 2014, as discussed in section VII of
this final rule.
We will adopt revisions to the list of eligible ICD-9-CM
diagnosis codes that meet the presumptive compliance criteria, with a
one-year delayed implementation date, as discussed in section VIII of
this final rule.
We will adopt non-quality-related revisions to IRF-PAI
sections effective October 1, 2014, as discussed in section IX of this
final rule.
We will adopt revisions and updates to quality measures
and reporting requirements under the quality reporting program for IRFs
in accordance with section 1886(j)(7) of the Act, effective October 1,
2014, as discussed in section XIV of this final rule.
B. Revisions to Existing Regulation Text
In this final rule, we will make the following revisions to the
existing regulations:
We will revise Sec. 412.25(a)(1)(iii) to specify a
minimum required number of beds that are not excluded from the
inpatient prospective payment system (IPPS) for a hospital that has an
IRF unit, with a one-year delayed implementation date to give providers
an opportunity to comply with the requirements, as described in section
XI of this final rule.
We will make technical corrections to Sec. 412.130, to
reflect prior changes to the regulations at Sec. 412.29 and Sec.
412.30 that we made in the FY 2012 IRF PPS final rule (76 FR 47836), as
described in section X of this final rule.
We will make clarifications to Sec. 412.630, to reflect
the scope of section 1886(j)(8) of the Act, as described in section XII
of this final rule.
We will revise Sec. 412.29(d), to clarify that Medicare
requires the rehabilitation physician's review and concurrence on the
preadmission screening for Medicare Part A Fee-for-Service patients
only, as described in section XIII of this final rule.
XVII. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. To
fairly evaluate whether an information collection should be approved by
OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995
requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
This final rule does not impose any new information collection
requirements as outlined in the regulation text. However, this final
rule does make reference to associated information collections that are
not discussed in the regulation text contained in this document. The
[[Page 47923]]
following is a discussion of these information collections, some of
which have already received OMB approval.
A. ICRs Regarding IRF QRP
As stated in section XIV. of this final rule, we are adopting one
new measure for use in the IRF QRP which will affect the increase
factor for FY 2016. This quality measure is: Influenza Vaccination
Coverage among Healthcare Personnel (NQF 0431). We are also
adopting 2 new measures that will affect the increase factor for FY
2017. The first is an All-Cause Unplanned Readmission Measure for 30
Days Post Discharge from Inpatient Rehabilitation Facilities. This
measure is a claims-based measure that does not require submission of
data by IRF providers. In addition, we are adopting the Percent of
Residents or Patients Who Were Assessed and Appropriately Given the
Seasonal Influenza Vaccine (Short-Stay) (NQF 0680) measure.
Finally, we are replacing a non-risk adjusted application of an NQF-
endorsed pressure ulcer measure, in which only numerator and
denominator data is collected, to use the NQF-endorsed version of this
measure ``Percent of Residents or Patients with Pressure Ulcers That
Are New or Worsened (Short-Stay)'' (NQF 0678), which is a
risk-adjusted measure. Each of these measures will be collected in the
manner described below:
1. Influenza Vaccination Coverage Among Healthcare Personnel (NQF
0431)
In section XIV. of this final rule, we are adopting the new
measure, Influenza Vaccination Coverage among Healthcare Personnel (NQF
0431) to the IRF QRP. IRFs will be required to collect data
related to the number of healthcare personnel working at a facility who
have been vaccinated against the influenza virus during a given
influenza vaccination season. The CDC has determined that the influenza
vaccination season begins on October 1st (or when the vaccine becomes
available) and ends on the following March 31st each year. This measure
requires that the provider submit only one report to NHSN by the data
submission deadline of May 15 following the close of the data
collection period each year.
It has become a common practice for healthcare facilities,
including IRFs, to promote vaccination of employees for the influenza
virus and to keep records of which of their staff members received this
vaccination each year. Therefore, we do not believe that IRFs will
incur any additional burden related to the collection of the data for
this measure.
We anticipate that it will take approximately 15 minutes to prepare
and transmit the required data for this measure to the CDC each year.
The reporting of the data for this measure can be done while the
provider is logged onto NHSN for the purpose of entering their CAUTI
measure data. We believe that this task can be completed by an
administrative person such as a Medical Secretary/Medical Data Entry
Clerk. The average hourly wage for Medical Records or Health
Information Technicians is $15.55.\27\ We estimate that the annual cost
to each IRF for the reporting of the staff influenza measure will be
$3.89.\28\ The annual cost across the 1161 IRFs in the U.S. that are
reporting data to CMS is estimated to be $4,516.\29\
---------------------------------------------------------------------------
\27\ According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a Medical Records & Health Information Technician is
$15.55. See: https://www.bls.gov/ooh/healthcare/medical-records-and-health-information-technicians.htm.
\28\ 15 minutes Administrative staff time to collect and report
staff influenza measure @ $15.55 per hour = $3.9889 per IRF per
year.
\29\ At the time of the writing of this rule, there were 1161
IRFs reporting quality data to CMS. ($3.9889 per IRF per year x 1161
IRFs in U.S. = $4,621516).
---------------------------------------------------------------------------
2. All-Cause Unplanned Readmission Measure for 30 Days Post Discharge
from Inpatient Rehabilitation Facilities
As stated in section XIV. of this final rule, data for this measure
will be collected from Medicare claims and therefore will not add any
additional reporting burden for IRFs.
3. Percent of Residents or Patients with Pressure Ulcers that are New
or Have Worsened (Short-Stay) (NQF 0678)
In section XIV of this final rule, we are adopting the NQF-endorsed
version of the measure titled ``Percent of Residents or Patients with
Pressure Ulcers That Are New or Worsened (Short-Stay)'' (NQF
0678), affecting the FY 2017 annual increase factor. To
support the standardized collection and calculation of this quality
measure, we are modifying the current Inpatient Rehabilitation
Facility-Patient Assessment Instrument (IRF-PAI) by replacing the
current pressure ulcer items with data elements similar or identical to
those collected through the Minimum Data Set 3.0 (MDS 3.0) used in
nursing homes. By building upon preexisting resources, we intend to
reduce administrative burden related to data collection and submission.
We anticipate that the initial setup and acclimation to pressure ulcer
data collection will have already occurred with the adoption of the
pressure ulcer measure for the IRF QRP for the FY 2014 annual increase
factor. Therefore, we believe the transition to reporting similar as
well as additional data elements for this measure will be less
burdensome.
We expect that the admission and discharge pressure ulcer data will
be collected by a clinician such as an RN because the assessment and
staging of pressure ulcers requires a high degree of clinical judgment
and experience. We estimate that it will take approximately 10 minutes
of time by the RN to perform the admission pressure ulcer assessment.
We further estimate that it will take an additional 15 minutes of time
to complete the discharge pressure ulcer assessment. We expect that
during these time periods, the RN would be engaged in the collection of
data for the purpose of the IRF QRP and would not be engaged in the
performance of routine patient care.
We estimate that there are 359,000 IRF-PAI submissions per year
\30\ and that there are 1161 IRFs in the U.S. reporting quality data to
CMS. Based on these figures, we estimate that each IRF will submit
approximately 309 IRF-PAIs per year or 26 IRF-PAIs per month.\31\
Assuming that each IRF-PAI submission requires 25 minutes of time by an
RN at an average hourly wage of $33.23,\32\ the yearly cost to each IRF
would be $4,278.36 \33\ and the annualized cost across all IRFs would
be $4,967,176.\34\
---------------------------------------------------------------------------
\30\ MedPAC, A Data Book: Health Care Spending and the Medicare
Program (June 2012), https://www.medpac.gov/chapters/Jun12DataBookSec8.pdf.
\31\ 359,000 IRF-PAIs per all IRFs per year/1161 IRFs in U.S. =
309 IRF-PAIs per each IRF per year.
309 IRF-PAI reports per IRF per year/12 months per year = 26
IRF-PAI reports per each IRF per year.
\32\ According to the U.S. Bureau of Labor Statistics, the mean
hourly wage for a Registered Nurse is $33.23. (See https://www.bls.gov/oes/2011/may/oes291111.htm).
\33\ 25 minutes x 309 IRF-PAI assessments per each IRF per year
= 7,725 minutes per each IRF per year.
7,725 minutes per each IRF per year/60 minutes per hour = 128.75
hours per each IRF per year.
128.75 hours per year x $33.23 per hour = $4,278.36 nursing
wages per each IRF per year.
\34\ $4,278.36 x 1161 IRF providers = $4,967,176 per all IRFs
per year.
---------------------------------------------------------------------------
We also expect that most IRFs will use administrative personnel,
such as a medical secretary or medical data entry clerk, to perform the
task of entering the IRF-PAI pressure ulcer assessment data into their
electronic health record (EHR) system and/or the CMS JIRVEN program. We
estimate that this data entry task will take no more than 3 minutes for
each IRF-PAI record or 15.45 hours for each IRF annually or
[[Page 47924]]
17,937 hours across all IRFs. As noted above, the average hourly wage
for a Medical Records & Health Information Technician is $15.55. As we
noted above, there are approximately 359,000 IRF-PAI submissions per
year and 1161 IRFs reporting quality data to CMS. Given this wage
information, the estimated total annual cost across all reporting IRFs
for the time required for entry of pressure ulcer data into the IRF-PAI
record is $278,930. We further estimate the average yearly cost to each
individual IRF to be $240.25.
We estimate that the combined annualized time burden related to the
pressure ulcer data item set for work performed, by the both clinical
and administrative staff will be 144.20 hours for each individual IRF
and 167,416 hours across all IRFs. The total estimated annualized cost
for collection and submission of pressure ulcer data is $4,518.61 for
each IRF and $5,246,106 across all IRFs. We estimate the cost for each
pressure ulcer submission to be $14.61.
4. Percent of Residents or Patients Who Were Assessed and Appropriately
Given the Seasonal Influenza Vaccine (Short-Stay) (NQF 0680)
In section XIV. of this final rule, we are adding the measure,
Percent of Residents or Patients Who Were Assessed and Appropriately
Given the Seasonal Influenza Vaccine (Short-Stay) (NQF 0680)
to the IRF QRP. We further are adding a new set of standardized data
elements now used in the MDS 3.0 to the IRF-PAI to collect the data
required for this measure.
IRFs are already required to complete and transmit certain IRF-PAI
data on all Medicare Part A Fee-for-Service and Medicare Part C
(Medicare Advantage) patients to receive payment from Medicare. By
building upon preexisting resources, we intend to reduce administrative
burden related to data collection and submission. We anticipate that
the initial setup and acclimation to data collection through the IRF-
PAI for purposes of reporting IRF quality measure data will have
already occurred with the adoption of the Pressure Ulcer measure for
the IRF QRP for the FY 2014 increase factor. Therefore, we believe the
transition to reporting an additional measure via the IRF-PAI may be
less burdensome.
We estimate that completion of the patient influenza measure item
set will take approximately 5 minutes to complete. The patient
influenza item set consists of three items (questions). Each item is
straightforward and does not require physical assessment for
completion. We estimate that it will take approximately 0.7 minutes to
complete each item, or 2.1 minutes to complete the entire item set.
However, in some cases, the person completing this item set may need to
consult the patient's medical record to obtain data about the patient's
influenza vaccination. Therefore, we have allotted 1.6 minutes per item
or a total of 5 minutes to complete the item set.
The IRF staff will be required to perform a full influenza
assessment only during the influenza vaccination season. The CDC
defines that influenza vaccination season as the time period from
October 1st (or when the vaccine becomes available) through March 31
each year. From April 1st through September 30th, IRFs are not required
to perform full influenza screening and may skip to the next item set
after checking the selection which indicates that the patient's IRF
stay occurred outside of the influenza vaccination season. Our time
estimate reflects the averaged amount of time necessary to complete the
influenza item set both during and outside the influenza vaccination
season.
We anticipate that the patient influenza item set will be completed
by a clinician such an RN, while completing the Quality Indicator
section of the IRF-PAI. It is most appropriate for an RN to complete
the influenza item set because it involves performing a skilled
assessment to determine, from a patient's records, whether the patient
has received a vaccination and, if not, to discuss with the patient any
medications or other related topics such as medication allergies, other
vaccinations that the patient may have had, and any contraindications
that might exist for receiving the influenza vaccination. The nurse has
knowledge and experience to determine the relevance of this information
to the patient influenza items and also to determine if the patient
should be given the influenza vaccination.
As noted above, we estimate that it will take approximately 5
minutes to complete the patient influenza measure item set. We have
also noted above that there are approximately 359,000 IRF-PAIs
completed annually across all 1161 IRFs that report IRF quality data to
CMS. This breaks down to approximately 309 IRF-PAIs completed by each
IRF yearly.\35\ We estimate that the annual time burden for reporting
the patient influenza vaccination measure data is 29,896 hours across
all IRFs in the U.S. and 26 hours for each individual IRF. According to
the U.S. Bureau of Labor, the hourly wage for a Registered Nurse is
$33.23. Taking all of the above information into consideration, we
estimate the annual cost across all IRFs for the submission of the
patient influenza measure data to be $993,433. We further estimate the
cost for each individual IRF to be $855.67. A summary of the public
comments received on our burden estimate for this measure and our
responses to those comments are discussed below.
---------------------------------------------------------------------------
\35\ 359,000 IRF-PAI reports per all IRFs per year/1161 IRFs in
U.S. = 309 IRF-PAI reports per each IRF per year.
---------------------------------------------------------------------------
Comment: The additional burden of data collection (that is, seeking
information directly from the patient or by searching through the paper
medical record) must not take away from limited resources in these
facilities which are needed to provide direct care.
Response: We agree that there will be some additional burden added
because IRFs will be required to check to see if the patient received
the influenza vaccination prior to admission to the IRF. However, we
believe that the burden will be minimal.
Most patients are transferred to IRFs from an acute care facility.
If the patient received the influenza vaccination while in the acute
care facility, there should be several places where the information
about the administration of this vaccination can be quickly and easily
located. The influenza vaccination is a medication, so the Medication
Administration Record would be one place that this information could be
located. Also, if this vaccination was ordered by a physician or the
acute care facility had standing orders for the administration of the
vaccination, then the Physicians Order section of the chart is another
place that is likely to contain the influenza vaccination information.
Comment: One commenter suggested that CMS' estimates on the burden
caused by the implementation of the two vaccination measures (Influenza
Vaccination Coverage among Healthcare Personnel (NQF 0431) and
Percent of Residents or Patients Who Were Assessed and Appropriately
Given the Seasonal Influenza Vaccine (Short-Stay) (NQF0680)
are inaccurate because they do not encompass changes that must be made
to its billing software, electronic medical records, or administrative
processes.
Response: When making a burden estimate, we estimate only those
activities and costs that are common to a majority of providers and
which can be fairly and accurately estimated across all IRFs.
Unfortunately, costs related to changes to billing and electronic
medical record software, or
[[Page 47925]]
administrative processes are costs that are so variable among different
IRFs we are not able to make an accurate estimate of these costs that
can be applied across all providers.
Costs for updates to electronic medical records are extremely
variable and will depend on many factors such as the manufacturer of
the electronic medical records software; whether there is a warranty
that covers updates; whether the IRF has a service contract which
covers updates; who the IRF hires to perform upgrades to its system;
where the IRF is geographically located; or whether the cost is
incurred by a large corporation that owns many IRFs or the IRF is a
solely owned and operated facility. In regard to costs for changes to
administrative processes, these costs are also difficult to define or
quantify as they are equally variable, if not more so than costs
related to changes to electronic record systems.
Even though it was not reflected in the burden estimate, CMS does
recognize that many IRFs will incur costs for changes that will be
required to billing software, electronic medical records, or
administrative processes. Some of these changes are required as a
result of the IRF QRP proposals that we are finalizing in this final
rule. However, we believe that some of these costs are also
attributable to non-quality related proposals that are being finalized
in this rule.
B. ICRs Regarding Non-Quality Related Changes to the IRF-PAI
We will revise several items on the IRF-PAI to provide greater
clarity for providers. The changes include updating several items
regarding the response options available to providers. Additionally, we
are removing several items that we believe are unnecessary for
providers to continue documenting on the IRF-PAI since those items are
already being documented in the patients' medical record. We are also
adding several items, such as a signature page, to fulfill providers'
request to have an organized way to document who has assessed the
patient and when that assessment took place. We do not estimate any
additional burden for IRFs to complete the IRF-PAI as a result of these
changes. We estimate the time that will be needed to complete the new
non-quality related proposed items, equals the time that was needed to
complete the previous non-quality related items. When the original
burden estimates were completed for the IRF-PAI, we estimated that the
proposed deletion of the non-quality related items would take
approximately 3 minutes to complete. Thus, removing these items the
IRF-PAI would decrease the total estimated burden of completing the
non-quality related portions of the IRF-PAI by 3 minutes. However, we
estimate that it will take about 3 minutes to complete the new non-
quality related items that we are proposing to add. Therefore, we
estimate no net change in the amount of time associated with completing
the non-quality related portions of the IRF-PAI and that the burden for
completing these portions of the IRF-PAI will not change.
We did not receive any comments specifically on the information
collection requirements regarding the non-quality related changes to
the IRF-PAI.
We will be submitting a revision to the current IRF-PAI collection
of information approval under (OMB control number 0938-0842) for OMB
review and approval.
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of the proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
CMS-1448-P, Fax: (202) 395-6974; or, Email: OIRA_submission@omb.eop.gov.
XVIII. Regulatory Impact Analysis
A. Statement of Need
This final rule updates the IRF prospective payment rates for FY
2014 as required under section 1886(j)(3)(C) of the Act. It responds to
section 1886(j)(5) of the Act, which requires the Secretary to publish
in the Federal Register on or before the August 1 that precedes the
start of each fiscal year, the classification and weighting factors for
the IRF PPS's case-mix groups and a description of the methodology and
data used in computing the prospective payment rates for that fiscal
year.
This rule implements sections 1886(j)(3)(C) and (D) of the Act.
Section 1886(j)(3)(C)(ii)(I) of the Act requires the Secretary to apply
a multi-factor productivity adjustment to the market basket increase
factor, and to apply other adjustments as defined by the Act. The
productivity adjustment applies to FYs from 2012 forward. The other
adjustments apply to FYs 2010 through 2019.
This rule also adopts some policy changes within the statutory
discretion afforded to the Secretary under section 1886(j) of the Act.
We will revise the list of diagnosis codes that are eligible under the
presumptive compliance method of calculating an IRF's compliance
percentage under the ``60 percent rule'' effective for compliance
review periods beginning on or after October 1, 2014 (a one-year
delay), update the IRF facility-level adjustment factors, revise
sections of the Inpatient Rehabilitation Facility-Patient Assessment
Instrument, revise requirements for acute care hospitals that have IRF
units beginning on or after October 1, 2014 (a one-year delay), clarify
the IRF regulation text regarding limitation of review, and revise and
update quality measures under the IRF quality reporting program. We
believe that the policy changes will enhance the clarity, accuracy, and
fairness of the IRF PPS.
B. Overall Impacts
We have examined the impacts of this final rule as required by
Executive Order 12866 (September 30, 1993, Regulatory Planning and
Review), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (September
19, 1980, Pub. L. 96-354) (RFA), section 1102(b) of the Act, section
202 of the Unfunded Mandates Reform Act of 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 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. A regulatory impact analysis (RIA) must be prepared for a
major final rule with economically significant effects ($100 million or
more in any one year). We estimate the total impact of the policy
updates described in this final rule by comparing the estimated
payments in FY 2014 with those in FY 2013. This analysis results in an
estimated $170 million increase for FY 2014 IRF PPS payments. As a
result, this final rule is designated as economically ``significant''
under section 3(f)(1) of Executive Order 12866, and hence a major rule
under the Congressional Review Act. Also, the rule has been reviewed by
OMB.
[[Page 47926]]
The Regulatory Flexibility Act (RFA) requires agencies to analyze
options for regulatory relief of small entities, if a rule has a
significant impact on a substantial number of small entities. For
purposes of the RFA, small entities include small businesses, nonprofit
organizations, and small governmental jurisdictions. Most IRFs and most
other providers and suppliers are small entities, either by having
revenues of $7 million to $34.5 million or less in any 1 year depending
on industry classification, or by being nonprofit organizations that
are not dominant in their markets. (For details, see the Small Business
Administration's final rule that set forth size standards for health
care industries, at 65 FR 69432 at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf, effective March 26, 2012.)
Because we lack data on individual hospital receipts, we cannot
determine the number of small proprietary IRFs or the proportion of
IRFs' revenue that is derived from Medicare payments. Therefore, we
assume that all IRFs (an approximate total of 1,100 IRFs, of which
approximately 60 percent are nonprofit facilities) are considered small
entities and that Medicare payment constitutes the majority of their
revenues. The Department of Health and Human Services generally uses a
revenue impact of 3 to 5 percent as a significance threshold under the
RFA. As shown in Table 18, we estimate that the net revenue impact of
this final rule on all IRFs is to increase estimated payments by
approximately 2.3 percent. However, we find that certain categories of
IRF providers would be expected to experience revenue impacts in the 3
to 5 percent range. We estimate a 5.0 percent overall impact for
teaching IRFs with resident to average daily census ratios of 10 to 19
percent, a 10.1 percent overall impact for teaching IRFs with a
resident to average daily census ratio greater than 19 percent, and a
4.1 percent overall impact for IRFs with a DSH patient percentage of 0
percent. As a result, we anticipate this final rule adoptes a net
positive impact on a substantial number of small entities. Medicare
fiscal intermediaries, Medicare Administrative Contractors, and
carriers are not considered to be small entities. Individuals and
States are not included in the definition of a small entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. As discussed in detail
below, the rates and policies set forth in this final rule will not
have a significant impact (not greater than 3 percent) on rural
hospitals based on the data of the 167 rural units and 18 rural
hospitals in our database of 1,134 IRFs for which data were available.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-04, enacted on March 22, 1995) also requires that agencies assess
anticipated costs and benefits before issuing any rule whose mandates
require spending in any one year of $100 million in 1995 dollars,
updated annually for inflation. In 2013, that threshold level is
approximately $141 million. This final rule will not impose spending
costs on State, local, or tribal governments, in the aggregate, or by
the private sector, of greater than $141 million.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on state and local governments,
preempts state law, or otherwise has federalism implications. As stated
above, this final rule will not have a substantial effect on State and
local governments, preempt state law, or otherwise have a federalism
implication.
C. Detailed Economic Analysis
1. Basis and Methodology of Estimates
This final rule sets forth policy changes and updates to the IRF
PPS rates contained in the FY 2013 notice (77 FR 44618). Specifically,
this final rule updates the CMG relative weights and average length of
stay values, the facility-level adjustment factors, the wage index, and
the outlier threshold for high-cost cases. This final rule also applies
a MFP adjustment to the FY 2014 RPL market basket increase factor in
accordance with section 1886(j)(3)(C)(ii)(I) of the Act, and a 0.3
percentage point reduction to the FY 2014 RPL market basket increase
factor in accordance with sections 1886(j)(3)(C)(ii)(II) and (D)(iii)
of the Act. Further, this final rule contains changes to the list of
ICD-9-CM codes that are used in the 60 percent rule presumptive
methodology. Since these changes are being made with a one-year delayed
implementation date, for compliance review periods beginning on or
after October 1, 2014, no financial impacts will accrue until FY 2015
from these changes. In addition, section XIV of this rule discusses the
first implementation (in FY 2014) of the required 2 percentage point
reduction of the market basket increase factor for any IRF that fails
to meet the IRF quality reporting requirements, in accordance with
section 1886(j)(7) of the Act.
We estimate that the impact of the changes and updates described in
this final rule will be a net estimated increase of $170 million in
payments to IRF providers. This estimate does not include the estimated
impacts of the changes to the list of ICD-9-CM codes that are used in
the 60 percent rule presumptive compliance (as discussed below), which
are effective for compliance review periods on or after October 1,
2014, or the estimated impacts of the implementation (in FY 2014) of
the required 2 percentage point reduction of the market basket increase
factor for any IRF that fails to meet the IRF quality reporting
requirements (as discussed below). The impact analysis in Table 18 of
this final rule represents the projected effects of the updates to IRF
PPS payments for FY 2014 compared with the estimated IRF PPS payments
in FY 2013. We determine the effects by estimating payments while
holding all other payment variables constant. We use the best data
available, but we do not attempt to predict behavioral responses to
these changes, and we do not make adjustments for future changes in
such variables as number of discharges or case-mix.
We note that certain events may combine to limit the scope or
accuracy of our impact analysis, because such an analysis is future-
oriented and, thus, susceptible to forecasting errors because of other
changes in the forecasted impact time period. Some examples could be
legislative changes made by the Congress to the Medicare program that
would impact program funding, or changes specifically related to IRFs.
Although some of these changes may not necessarily be specific to the
IRF PPS, the nature of the Medicare program is such that the changes
may interact, and the complexity of the interaction of these changes
could make it difficult to predict accurately the full scope of the
impact upon IRFs.
In updating the rates for FY 2014, we are adopting standard annual
revisions described in this final rule (for example, the update to the
wage and market basket indexes used to adjust the Federal rates). We
are also implementing a productivity adjustment to the FY 2014 RPL
market basket increase factor in accordance with section
1886(j)(3)(C)(ii)(I) of the Act, and
[[Page 47927]]
a 0.3 percentage point reduction to the FY 2014 RPL market basket
increase factor in accordance with sections 1886(j)(3)(C)(ii)(II) and
(D)(iii) of the Act. We estimate the total increase in payments to IRFs
in FY 2014, relative to FY 2013, will be approximately $170 million.
This estimate is derived from the application of the FY 2014 RPL
market basket increase factor, as reduced by a productivity adjustment
in accordance with section 1886(j)(3)(C)(ii)(I) of the Act, and a 0.3
percentage point reduction in accordance with sections
1886(j)(3)(C)(ii)(II) and (D)(iii) of the Act, which yields an
estimated increase in aggregate payments to IRFs of $135 million.
Furthermore, there is an additional estimated $35 million increase in
aggregate payments to IRFs due to the update to the outlier threshold
amount. Outlier payments are estimated to increase from approximately
2.5 percent in FY 2013 to 3.0 percent in FY 2014. Therefore, summed
together, we estimate that these updates will result in a net increase
in estimated payments of $170 million from FY 2013 to FY 2014.
The effects of the updates that impact IRF PPS payment rates are
shown in Table 18. The following updates that affect the IRF PPS
payment rates are discussed separately below:
The effects of the update to the outlier threshold amount,
from approximately 2.5 percent to 3.0 percent of total estimated
payments for FY 2014, consistent with section 1886(j)(4) of the Act.
The effects of the annual market basket update (using the
RPL market basket) to IRF PPS payment rates, as required by section
1886(j)(3)(A)(i) and sections 1886(j)(3)(C) and (D) of the Act,
including a productivity adjustment in accordance with section
1886(j)(3)(C)(i)(I) of the Act, and a 0.3 percentage point reduction in
accordance with sections 1886(j)(3)(C) and (D) of the Act.
The effects of applying the budget-neutral labor-related
share and wage index adjustment, as required under section 1886(j)(6)
of the Act.
The effects of the budget-neutral changes to the CMG
relative weights and average length of stay values, under the authority
of section 1886(j)(2)(C)(i) of the Act.
The effects of the updates to the Rural, LIP, and Teaching
Status adjustment factors, using an updated methodology.
The total change in estimated payments based on the FY
2014 payment changes relative to the estimated FY 2013 payments.
2. Description of Table 18
Table 18 categorizes IRFs by geographic location, including urban
or rural location, and location with respect to CMS's 9 census
divisions (as defined on the cost report) of the country. In addition,
the table divides IRFs into those that are separate rehabilitation
hospitals (otherwise called freestanding hospitals in this section),
those that are rehabilitation units of a hospital (otherwise called
hospital units in this section), rural or urban facilities, ownership
(otherwise called for-profit, non-profit, and government), by teaching
status, and by disproportionate share patient percentage (DSH PP). The
top row of Table 18 shows the overall impact on the 1,134 IRFs included
in the analysis.
The next 12 rows of Table 18 contain IRFs categorized according to
their geographic location, designation as either a freestanding
hospital or a unit of a hospital, and by type of ownership; all urban,
which is further divided into urban units of a hospital, urban
freestanding hospitals, and by type of ownership; and all rural, which
is further divided into rural units of a hospital, rural freestanding
hospitals, and by type of ownership. There are 949 IRFs located in
urban areas included in our analysis. Among these, there are 733 IRF
units of hospitals located in urban areas and 216 freestanding IRF
hospitals located in urban areas. There are 185 IRFs located in rural
areas included in our analysis. Among these, there are 167 IRF units of
hospitals located in rural areas and 18 freestanding IRF hospitals
located in rural areas. There are 302 for-profit IRFs. Among these,
there are 263 IRFs in urban areas and 39 IRFs in rural areas. There are
688 non-profit IRFs. Among these, there are 571 urban IRFs and 117
rural IRFs. There are 144 government-owned IRFs. Among these, there are
115 urban IRFs and 29 rural IRFs.
The remaining four parts of Table 18 show IRFs grouped by their
geographic location within a region, by teaching status, and by DSH PP.
First, IRFs located in urban areas are categorized with respect to
their location within a particular one of the nine Census geographic
regions. Second, IRFs located in rural areas are categorized with
respect to their location within a particular one of the nine Census
geographic regions. In some cases, especially for rural IRFs located in
the New England, Mountain, and Pacific regions, the number of IRFs
represented is small. IRFs are then grouped by teaching status,
including non-teaching IRFs, IRFs with an intern and resident to
average daily census (ADC) ratio less than 10 percent, IRFs with an
intern and resident to ADC ratio greater than or equal to 10 percent
and less than or equal to 19 percent, and IRFs with an intern and
resident to ADC ratio greater than 19 percent. Finally, IRFs are
grouped by DSH PP, including IRFs with zero DSH PP, IRFs with a DSH PP
less than 5 percent, IRFs with a DSH PP between 5 and less than 10
percent, IRFs with a DSH PP between 10 and 20 percent, and IRFs with a
DSH PP greater than 20 percent.
The estimated impacts of each policy described in this final rule
to the facility categories listed above are shown in the columns of
Table 18. The description of each column is as follows:
Column (1) shows the facility classification categories
described above.
Column (2) shows the number of IRFs in each category in
our FY 2012 analysis file.
Column (3) shows the number of cases in each category in
our FY 2012 analysis file.
Column (4) shows the estimated effect of the adjustment to
the outlier threshold amount.
Column (5) shows the estimated effect of the update to the
IRF PPS payment rates, which includes a productivity adjustment in
accordance with section 1886(j)(3)(C)(ii)(I) of the Act, and a 0.3
percentage point reduction in accordance with sections
1886(j)(3)(C)(ii)(II) and (D)(iii) of the Act.
Column (6) shows the estimated effect of the update to the
IRF labor-related share and wage index, in a budget-neutral manner.
Column (7) shows the estimated effect of the update to the
CMG relative weights and average length of stay values, in a budget-
neutral manner.
Column (8) shows the estimated effect of the update to the
facility adjustment factors using an updated methodology, in a budget-
neutral manner.