[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Rules and Regulations]
[Pages 47860-47934]
From the Federal Register Online via the Government Publishing 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
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Centers for Medicare & Medicaid Services
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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]]
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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.
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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 http://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
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Provision description Transfers
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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.
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Provision description Costs
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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.
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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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/index.html. 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: http://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: http://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: http://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 http://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 http://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 http://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 http://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 http://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 http://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 http://www.whitehouse.gov/omb/bulletins/index.html.
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 http://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 http://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 http://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 http://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
http://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 http://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
http://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 http://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 (http://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: http://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
http://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 http://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 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 http://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 http://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 http://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 http://www.qualityforum.org/Setting_Priorities/NPP/National_Priorities_Partnership.aspx, the HHS
Strategic Plan at http://www.hhs.gov/secretary/about/priorities/priorities.html, and the National Strategy for Quality Improvement in
Healthcare at http://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 http://www.cdc.gov/nhsn/inpatient-rehab/hcp-vacc/index.html 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 (http://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: http://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 http://www.cdc.gov/nhsn/inpatient-rehab/hcp-vacc/index.html.
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 http://www.cdc.gov/nhsn/inpatient-rehab/hcp-vacc/index.html and at http://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.
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\5\ Federal Register/Vol. 76, No. 160/Thursday, August 18, 2011/
Rules and Regulations, C1a.
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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. http://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.
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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.
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\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.
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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)
(http://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: http://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).
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\16\ National Quality Forum. ``Patient Outcomes: All-Cause
Readmissions Expedited Review 2011''. July 2012. pp12.
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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 http://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'' (http://
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\
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\17\ National Quality Forum. Measure Applications Partnership
Pre-Rulemaking Report: 2013 Recommendations of Measures Under
Consideration by HHS: February 2013. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=72738.
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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 http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/index.html. 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
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\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 http://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 http://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.
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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.
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\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)
http://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: http://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 http://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 http://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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/index.html.
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 http://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 http://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)
http://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
http://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 http://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/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 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 http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/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 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 http://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: http://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
[email protected]. 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\ http://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/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
[[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 http://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 http://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: http://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\
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\30\ MedPAC, A Data Book: Health Care Spending and the Medicare
Program (June 2012), http://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 http://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: [email protected].
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 http://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.
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
[[Page 47928]]
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 %]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adjusted
market FY 2014
basket CBSA wage Total
Facility classification Number of Number of Outlier increase index and CMG Facility percent
IRFs cases factor labor- adjust. change
for FY share
2014 \1\
(1) (2) (3) (4) (5) (6) (7) (8) (9)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total........................................................... 1,134 382,756 0.5 1.8 0.0 0.0 0.0 2.3
Urban unit...................................................... 733 181,133 0.7 1.8 0.0 0.0 0.2 2.8
Rural unit...................................................... 167 27,098 0.6 1.8 0.1 0.0 -2.4 0.0
Urban hospital.................................................. 216 168,609 0.2 1.8 -0.1 0.0 0.3 2.1
Rural hospital.................................................. 18 5,916 0.1 1.8 -0.1 -0.1 -3.0 -1.3
Urban For-Profit................................................ 263 143,162 0.2 1.8 -0.2 0.0 0.2 2.0
Rural For-Profit................................................ 39 7,728 0.3 1.8 0.1 0.0 -2.9 -0.7
Urban Non-Profit................................................ 571 178,424 0.6 1.8 0.2 0.0 0.2 2.8
Rural Non-Profit................................................ 117 20,578 0.5 1.8 0.0 0.0 -2.4 -0.1
Urban Government................................................ 115 28,156 0.7 1.8 -0.2 0.0 0.3 2.7
Rural Government................................................ 29 4,708 0.7 1.8 0.2 0.0 -2.6 0.1
Urban........................................................... 949 349,742 0.5 1.8 0.0 0.0 0.2 2.5
Rural........................................................... 185 33,014 0.5 1.8 0.0 0.0 -2.5 -0.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Urban by Region
--------------------------------------------------------------------------------------------------------------------------------------------------------
Urban New England............................................... 32 16,779 0.3 1.8 0.7 0.0 0.0 2.8
Urban Middle Atlantic........................................... 140 59,466 0.4 1.8 0.0 0.0 0.7 2.9
Urban South Atlantic............................................ 130 62,557 0.3 1.8 -0.3 0.0 0.0 1.9
Urban East North Central........................................ 182 52,632 0.6 1.8 0.2 0.0 0.6 3.2
Urban East South Central........................................ 49 24,489 0.2 1.8 -0.8 0.0 0.4 1.7
Urban West North Central........................................ 73 18,097 0.6 1.8 0.5 0.0 -0.1 2.8
Urban West South Central........................................ 171 67,575 0.4 1.8 -0.1 0.0 0.3 2.4
Urban Mountain.................................................. 73 23,459 0.6 1.8 -0.5 0.0 0.1 2.0
Urban Pacific................................................... 99 24,688 0.9 1.8 0.7 0.0 -0.9 2.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rural by Region
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rural New England............................................... 6 1,400 0.8 1.8 -0.5 -0.1 -1.8 0.1
Rural Middle Atlantic........................................... 15 2,711 0.3 1.8 -0.2 0.0 -2.2 -0.3
Rural South Atlantic............................................ 24 5,624 0.3 1.8 0.1 0.0 -2.5 -0.3
Rural East North Central........................................ 32 5,595 0.5 1.8 0.3 0.0 -2.4 0.1
Rural East South Central........................................ 22 3,852 0.4 1.8 0.0 0.1 -2.7 -0.4
Rural West North Central........................................ 27 3,660 0.7 1.8 -0.7 0.0 -2.2 -0.4
Rural West South Central........................................ 48 9,130 0.4 1.8 0.4 0.0 -3.1 -0.6
Rural Mountain.................................................. 7 664 1.2 1.8 0.2 0.1 -1.5 1.9
Rural Pacific................................................... 4 378 1.9 1.8 0.1 -0.1 -1.1 2.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Teaching Status
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-teaching.................................................... 1,018 334,415 0.4 1.8 0.0 0.0 -0.2 2.0
Resident to ADC less than 10%................................... 65 32,238 0.5 1.8 0.1 0.0 0.6 3.0
Resident to ADC 10%-19%......................................... 39 14,504 0.8 1.8 0.1 0.0 2.3 5.0
Resident to ADC greater than 19%................................ 12 1,599 0.6 1.8 0.3 0.0 7.1 10.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disproportionate Share Patient Percentage (DSH PP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
DSH PP = 0%..................................................... 38 7,859 1.1 1.8 0.2 0.0 1.0 4.1
DSH PP less than 5%............................................. 195 64,484 0.4 1.8 -0.1 0.0 0.8 2.9
DSH PP 5%-10%................................................... 323 123,384 0.3 1.8 -0.1 0.0 0.3 2.4
DSH PP 10%-20%.................................................. 347 124,564 0.4 1.8 0.1 0.0 -0.1 2.2
DSH PP greater than 20%......................................... 231 62,465 0.7 1.8 0.0 0.0 -1.1 1.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
[[Page 47929]]
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 recently-implemented 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.
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 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 Facility-Level 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. 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
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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 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 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