Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2010, 39436-39496 [E9-18587]
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39436
Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
42 CFR Parts 409, 424, 484, and 489
[CMS–1560–P]
RIN 0938–AP20
Medicare Program; Home Health
Prospective Payment System Rate
Update for Calendar Year 2010
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
SUMMARY: This proposed rule sets forth
an update to the Home Health
Prospective Payment System (HH PPS)
rates; the national standardized 60-day
episode rates, the national per-visit
rates, the non-routine medical supply
(NRS) conversion factor, and the low
utilization payment amount (LUPA)
add-on payment amount, under the
Medicare prospective payment system
for home health agencies effective
January 1, 2010. In addition, this rule
proposes a change to the HH PPS outlier
policy and proposes to require the
submission of OASIS data as a
condition for payment under the HH
PPS. Also, this rule proposes payment
safeguards that would improve our
enrollment process, improve the quality
of care that Medicare beneficiaries
receive from HHAs, and reduce the
Medicare program’s vulnerability to
fraud. This rule also proposes clarifying
language to the ‘‘skilled services’’
section and Condition of Participation
(CoP) section of our regulations. This
proposed rule also clarifies the coverage
of routine medical supplies under the
HH PPS. We are also soliciting
comments on: Physician/patient
interaction associated with the home
health plan of care (POC); a Consumer
Assessment of Healthcare Providers and
Systems (CAHPS) Home Health Care
Survey; the Outcome and Assessment
Information Set (OASIS), Version C,
effective January 1, 2010; proposed pay
for reporting measures for use in CY
2011; and a number of minor paymentrelated issues. We are also responding to
comments received as a result of our
solicitation in the CY 2008 HH PPS final
rule with comment period.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on September 28, 2009.
ADDRESSES: In commenting, please refer
to file code CMS–1560–P. Because of
staff and resource limitations, we cannot
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accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the instructions under the ‘‘More Search
Options’’ tab.
2. By regular mail. You may mail
written comments to the following
address only: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1560–P, P.O. Box 8016, Baltimore,
MD 21244–1850.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–1560–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201.
(Because access to the interior of the Hubert
H. Humphrey Building is not readily
available to persons without Federal
government identification, commenters are
encouraged to leave their comments in the
CMS drop slots located in the main lobby of
the building. A stamp-in clock is available for
persons wishing to retain a proof of filing by
stamping in and retaining an extra copy of
the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call (410) 786–7195 in advance to
schedule your arrival with one of our
staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
Submission of comments on
paperwork requirements. You may
submit comments on this document’s
paperwork requirements by following
the instructions at the end of the
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‘‘Collection of Information
Requirements’’ section in this
document.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. EST. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
FOR FURTHER INFORMATION CONTACT:
Randy Throndset, (410) 786–0131
(overall HH PPS).
Sharon Ventura, (410) 786–1985 (for
information related to payment rates
and wage indexes).
James Bossenmeyer, (410) 786–9317 (for
information related to payment
safeguards).
Doug Brown, (410) 786–0028 (for
quality issues).
Kathleen Walch, (410) 786–7970 (for
skilled services requirements and
clinical issues).
Table of Contents
I. Background
A. Requirements of the Balanced Budget
Act of 1997 for Establishing the
Prospective Payment System for Home
Health Services
B. Deficit Reduction Act of 2005
C. System for Payment of Home Health
Services
D. Updates to the HH PPS
II. Analysis of and Responses to Comments
on the HH PPS Refinement and Rate
Update for CY 2008
III. Provisions of the Proposed Regulation
A. Outlier Policy
B. Case-Mix Measurement Analysis
C. Proposed CY 2010 Payment Rate Update
1. Home Health Market Basket Update
2. Home Health Care Quality Improvement
3. Home Health Wage Index
4. Proposed CY 2010 Payment Update
a. National Standardized 60-Day Episode
Rate
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b. Proposed Updated CY 2010 National
Standardized 60-Day Episode Payment
Rate
c. Proposed National Per-Visit Rates Used
To Pay LUPAs and Compute Imputed
Costs Used in Outlier Calculations
d. Proposed LUPA Add-On Payment
Amount Update
e. Proposed Non-Routine Medical Supply
Conversion Factor Update
D. OASIS Issues
1. HIPPS Code Reporting
2. OASIS Submission as a Condition for
Payment
E. Qualifications for Coverage as They
Relate to Skilled Services Requirements
F. OASIS for Significant Change in
Condition No Longer Associated With
Payment
G. Proposed Payment Safeguards for Home
Health Agencies
H. Physician Certification and
Recertification of the Home Health Plan
of Care
I. Routine Medical Supplies
IV. Collection of Information Requirements
A. ICRs Regarding the Requirements for
Home Health Services
B. ICRs Regarding Deactivation of Medicare
Billing Privileges
C. ICRs Regarding Prohibition Against Sale
or Transfer of Billing Privileges
D. ICRs Regarding Patient Assessment Data
V. Response to Comments
VI. Regulatory Impact Analysis
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I. Background
A. Requirements of the Balanced Budget
Act of 1997 for Establishing the
Prospective Payment System for Home
Health Services
The Balanced Budget Act of 1997
(BBA) (Pub. L. 105–33) enacted on
August 5, 1997, significantly changed
the way Medicare pays for Medicare
home health services. Section 4603 of
the BBA mandated the development of
the home health prospective payment
system (HH PPS). Until the
implementation of a HH PPS on October
1, 2000, home health agencies (HHAs)
received payment under a cost-based
reimbursement system.
Section 4603(a) of the BBA mandated
the development of a HH PPS for all
Medicare-covered home health services
provided under a plan of care (POC) that
were paid on a reasonable cost basis by
adding section 1895 of the Social
Security Act (the Act), entitled
‘‘Prospective Payment For Home Health
Services’’. Section 1895(b)(1) of the Act
requires the Secretary to establish a HH
PPS for all costs of home health services
paid under Medicare.
Section 1895(b)(3)(A) of the Act
requires that: (1) The computation of a
standard prospective payment amount
include all costs for home health
services covered and paid for on a
reasonable cost basis and be initially
based on the most recent audited cost
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report data available to the Secretary,
and (2) the prospective payment
amounts be standardized to eliminate
the effects of case-mix and wage levels
among HHAs.
Section 1895(b)(3)(B) of the Act
addresses the annual update to the
standard prospective payment amounts
by the home health applicable
percentage increase.
Section 1895(b)(4) of the Act governs
the payment computation. Sections
1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the
Act require the standard prospective
payment amount to be adjusted for casemix and geographic differences in wage
levels.
Section 1895(b)(4)(B) of the Act
requires the establishment of an
appropriate case-mix change adjustment
factor that adjusts for significant
variation in costs among different units
of services.
Similarly, section 1895(b)(4)(C) of the
Act requires the establishment of wage
adjustment factors that reflect the
relative level of wages, and wage-related
costs applicable to home health services
furnished in a geographic area
compared to the applicable national
average level. Pursuant to 1895(b)(4)(c),
the wage-adjustment factors used by the
Secretary may be the factors used under
section 1886(d)(3)(E) of the Act.
Section 1895(b)(5) of the Act gives the
Secretary the option to make additions
or adjustments to the payment amount
otherwise paid in the case of outliers
because of unusual variations in the
type or amount of medically necessary
care. Total outlier payments in a given
fiscal year (FY) or year may not exceed
5 percent of total payments projected or
estimated.
In accordance with the statute, we
published a final rule (65 FR 41128) in
the Federal Register on July 3, 2000, to
implement the HH PPS legislation. The
July 2000 final rule established
requirements for the new HH PPS for
home health services as required by
section 4603 of the BBA, as
subsequently amended by section 5101
of the Omnibus Consolidated and
Emergency Supplemental
Appropriations Act (OCESAA) for Fiscal
Year 1999, (Pub. L. 105–277), enacted
on October 21, 1998; and by sections
302, 305, and 306 of the Medicare,
Medicaid, and SCHIP Balanced Budget
Refinement Act (BBRA) of 1999, (Pub. L.
106–113), enacted on November 29,
1999. The requirements include the
implementation of a HH PPS for home
health services, consolidated billing
requirements, and a number of other
related changes. The HH PPS described
in that rule replaced the retrospective
reasonable cost-based system that was
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used by Medicare for the payment of
home health services under Part A and
Part B. For a complete and full
description of the HH PPS as required
by the BBA, see the July 2000 HH PPS
final rule (65 FR 41128 through 41214).
B. Deficit Reduction Act of 2005
On February 8, 2006, the Deficit
Reduction Act of 2005 (Pub. L. 109–171)
(DRA) was enacted. Section 5201 of the
DRA requires HHAs to submit data for
purposes of measuring health care
quality, and links the quality data
submission to payment. This
requirement is applicable for CY 2007
and each subsequent year. If an HHA
does not submit quality data, the home
health market basket percentage
increase will be reduced 2 percentage
points. In accordance with the statute,
we published a final rule (71 FR 65884,
65935) in the Federal Register on
November 9, 2006 to implement the
pay-for-reporting requirement of the
DRA, codified at 42 CFR 484.225(h) and
(i).
C. System for Payment of Home Health
Services
Generally, Medicare makes payment
under the HH PPS on the basis of a
national standardized 60-day episode
payment rate that is adjusted for the
applicable case-mix and wage index.
The national standardized 60-day
episode rate includes the six home
health disciplines (skilled nursing,
home health aide, physical therapy,
speech-language pathology,
occupational therapy, and medical
social services). Payment for nonroutine medical supplies (NRS), is no
longer part of the national standardized
60-day episode rate and is computed by
multiplying the relative weight for a
particular NRS severity level by the NRS
conversion factor (See section III.C.4.e).
Durable medical equipment covered
under the home health benefit is paid
for outside the HH PPS payment. To
adjust for case-mix, the HH PPS uses a
153-category case-mix classification to
assign patients to a home health
resource group (HHRG). Clinical needs,
functional status, and service utilization
are computed from responses to selected
data elements in the OASIS assessment
instrument.
For episodes with four or fewer visits,
Medicare pays on the basis of a national
per-visit rate by discipline; an episode
consisting of four or fewer visits within
a 60-day period receives what is referred
to as a low utilization payment
adjustment (LUPA). Medicare also
adjusts the national standardized 60-day
episode payment rate for certain
intervening events that are subject to a
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partial episode payment adjustment
(PEP adjustment). For certain cases that
exceed a specific cost threshold, an
outlier adjustment may also be
available.
D. Corrections
We published a final rule with
comment period in the Federal Register
on August 29, 2007 (72 FR 49762) that
set forth a refinement and rate update to
the 60-day national episode rates and
the national per-visit rates under the
Medicare prospective payment system
for home health services for CY 2008. In
this final rule with comment period, in
Table 10B (72 FR 49854), the short
description for ICD–9–CM code 250.8x
& 707.10–707.9 should read ‘‘PRIMARY
DIAGNOSIS = 250.8x AND FIRST
OTHER DIAGNOSIS = 707.10–707.9’’.
Instead of a formal correction notice, we
are notifying the public of this
correction in this proposed rule, and
subsequent final rule.
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E. Updates to the HH PPS
As required by section 1895(b)(3)(B)
of the Act, we have historically updated
the HH PPS rates annually in the
Federal Register.
We published a notice in the Federal
Register on November 3, 2008 (73 FR
65351) that set forth the update to the
60-day national episode rates and the
national per-visit rates under the
Medicare prospective payment system
for home health services for CY 2009.
II. Analysis of and Responses to
Comments on the HH PPS Refinement
and Rate Update for CY 2008
Our August 29, 2007 final rule with
comment period set forth an update to
the 60-day national episode rates and
the national per-visit rates under the
Medicare prospective payment system
for HHAs for CY 2008. For that final
rule, analysis performed on home health
claims data, from CY 2005, indicated a
12.78 percent increase in the observed
case-mix since 2000. The case-mix
represented the variations in conditions
of the patient population served by the
HHAs. We then performed a more
detailed analysis on the 12.78 percent
increase in case-mix to see if any
portion of that increase was associated
with a real change in the actual clinical
condition of home health patients. CMS
examined data on demographics, family
support, pre-admission location, clinical
severity, and non-home health Part A
Medicare expenditure data to predict
the average case mix weight for 2005. As
a result of that analysis, CMS recognized
that an 11.75 percent increase in casemix was due to changes in coding
practices and documentation rather than
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to treatment of more resource-intensive
patients.
To account for the changes in casemix that were not related to an
underlying change in patient health
status, CMS implemented a reduction
over 4 years in the national
standardized 60-day episode payment
rates and the NRS conversion factor.
That reduction was to be taken at 2.75
percent per year for three years
beginning in CY 2008 and at 2.71
percent for the fourth year in CY 2011.
CMS indicated that it would continue to
monitor for any further increase in casemix that was not related to a change in
patient status, and would adjust the
percentage reductions and/or
implement further case-mix change
adjustments in the future.
The CY 2008 HH PPS final rule with
comment period specifically solicited
comments on the 2.71 percent reduction
that is scheduled to occur in 2011. In
response, we received approximately 44
items of correspondence from the
public. Comments originated from trade
associations, HHAs, hospitals, and
health care professionals such as
physicians, nurses, social workers, and
physical and occupational therapists. In
the HH PPS Rate Update for CY 2009,
we stated that we would delay our
responses to these comments until
future rulemaking, enabling us to
respond more comprehensively as more
current data became available. The
following discussion, arranged by
subject area, includes our responses to
the comments.
A. Payment Reductions in the 4th Year
(2011)
Comment: Commenters requested that
CMS release the Abt technical report so
that the industry could review the data
and information within it. Without the
Abt report, the commenters stated the
industry would be unable to offer
meaningful comments on the case mixreductions.
Response: The Abt Technical Report
was posted online and made available
to the public on April 30, 2008 at:
https://www.cms.hhs.gov/Reports/
downloads/
Coleman_Final_April_2008.pdf.
Although we posted the report later
than anticipated, we believe that the CY
2008 HH PPS final rule with comment
period adequately presented
information, documentation and
evidence describing the Abt case-mix
study and CMS’ rationale for the
reductions. Accordingly, we believe we
have provided sufficient time and
information to the public to fully review
and comment upon the rate reductions
that will take effect in CY 2011.
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Comment: A commenter suggested
that the 4th year cut of 2.71 percent be
eliminated or indefinitely deferred until
better data are available. Some
commenters stated that an additional
year of rate cuts will place a financial
burden on HHAs, and will result in
limited access to home care, especially
in rural areas. These commenters further
state that limited access may result in
more hospitalizations and/or care being
provided in more costly settings.
Commenters also stated that imposing a
4th year reduction on HHAs would be
detrimental and unduly harsh, as many
HHAs are already struggling to meet the
rising costs of providing care, and that
the reductions will cause HHAs to
operate at negative margins and likely
close.
Several commenters suggested
alternatives to CMS’ approach to
adjusting for nominal case-mix. For
example, one commenter suggested
spreading the total cuts across a 6-year
period rather than a 4-year period,
enabling CMS to better monitor the
impact of the CY 2008 HH PPS
refinements and CY 2008 and 2009
reductions prior to imposing additional
reductions.
Another commenter suggested that
CMS withdraw its decision to reduce
the payment rates until CMS could
design and implement a better method
to analyze changes in the case-mix,
based on adjusted final claims data that
would utilize patient characteristics in
the model, as well as changes in perpatient annual expenditures, patient
clinical, functional, and service
utilization data, and dynamic factors in
the Medicare system that impact on the
nature of patients served with home
health care.
Response: Our continued analysis
shows that Medicare nominal case-mix
continues to increase. Therefore, we
continue to believe it necessary to
reduce rates through 2011 to
counterbalance the Medicare
expenditure effects of this nominal
increase. We also continue to believe
that phasing in the reductions over a
four-year period provides fair and ample
time for HHAs to prepare for the
reductions.
As more current data become
available, we will continue to update
our case-mix analysis. As discussed in
Section III.B. of this proposed rule,
based on analysis of data through 2007,
nominal case-mix has further increased.
We now estimate that the nominal casemix has grown by an estimated 13.56
percent between FY 1999 (the Interim
Payment System (IPS) baseline period)
and 2007, an additional 1.81 percentage
points above the previously recognized
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increase. If we were to account for the
entire 13.56 percent increase in nominal
case-mix in one year (taking into
account that we have already imposed
2.75 percentage reductions in CY 2008
and CY 2009), we estimate that the
percentage reduction in the national
standardized 60-day episode payment
rates and the NRS conversion factor
would be 6.89 percent in CY 2010. If we
were to account for the entire 13.56
percent increase in nominal case-mix
over two years (taking into account that
we have already imposed 2.75
percentage reductions in CY 2008 and
CY 2009), we estimate that the
percentage reduction in the national
standardized 60-day episode payment
rates and the NRS conversion factor for
each of the remaining two years (2010
and 2011) would be 3.51 percent per
year. As discussed in Section II.C. of
this proposed rule, we currently plan to
move forward with the CY 2010
reduction of 2.75 percent, as set forth in
the CY 2008 final rule. However, we
note that, in light of, among other
things, new policy developments, more
recent information, or changed
circumstances from the time the CY
2008 rule was published, the Secretary
is also considering making additional
changes in the final rule to account for
the residual increase in nominal casemix discussed above. In such an
instance, we would consider accounting
for the residual increase in nominal
case-mix in one year in the final rule,
which we estimate would result in a
6.89 percent reduction to the national
standardized 60-day episode payment
rates and the NRS conversion factor for
CY 2010. We are seeking comments on
the full range of potential nominal casemix reduction percentages.
With high projected HH margins and
continued growth in the number of new
HH agencies, we do not believe that the
2.71 percent reduction for 2011 will
result in decreased access to home
health care for Medicare beneficiaries.
The Medicare Payment Advisory
Commission’s (MedPAC) March 2009
Annual Report states that the home
health industry margin for 2007 was
16.6 percent and projects that average
margins for 2009, which considers the
2.75 reduction, will be 12.2 percent.
MedPAC also analyzed the average rate
of HH cost growth and found that in
most years, the rate of actual cost
growth in HHAs has been lower than
the rate of inflation indicated by the
home health market basket. MedPAC
reports that payments for HHAs have
exceeded costs for all of the period
under PPS by a wide margin.
Also, in their March 2009 report,
MedPAC reports a 32 percent growth in
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the number of HH agencies since 2003,
stating that the supply of agencies
continues to increase faster than the
growth in the overall number of
Medicare beneficiaries. We believe that
new home health providers continue to
enter the home health industry because
Medicare payment levels give them
adequate incentive to do so.
In response to commenters who
suggested that we consider alternative
methods to identify nominal case-mix
before we impose the CY 2011
reductions, we continue to believe that
the Abt model adequately identifies
nominal case-mix. As we described in
our August 2007 final rule, our
enhanced model included variables
such as changes in the age structure of
the home health user population,
changes in the types of patients being
admitted to home health, utilization of
Medicare Part A services in the 120 days
leading up to home health, the type of
preadmission acute care stays when the
patient last had such a stay and
variables describing living situations.
Many of these model enhancements
addressed suggestions made by the
industry in their proposed rule
comments.
B. General Case-mix Comments
Our August 29, 2007 final rule with
comment period solicited comments
only on the 2.71 percent fourth year
reduction (72 FR 49762). Nevertheless,
we received several comments unrelated
to the fourth year reduction. Because
such comments (including comments on
outliers, LUPAs (Low Utilization
Payment Adjustments), OASIS, wage
index, operational issues, diagnosis
coding, HHRGs, and wound care
payment) are out of the scope of this
rulemaking, we are not responding to
these comments in this proposed rule.
However, we are responding to
comments on case-mix measurement
methodology, as we believe such
comments are tangentially related to the
reduction for CY 2011, and because we
wish to fully address this issue.
Comment: A commenter stated that
the August 27, 2007 final rule with
comment period was not a ‘‘logical
outgrowth’’ of the May 4, 2007 proposed
rule. The commenter stated that CMS
used a different methodology for
evaluating case-mix weight scores and
changes in patient characteristics than
had been used in the proposed rule. The
commenter recommended that CMS
engage in another cycle of rulemaking in
order to provide further opportunity to
comment.
Response: The policy adopted in the
August 2007 final rule was a policy that
adjusted payments in order to account
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39439
for increases in nominal case-mix. This
policy was both proposed and finalized.
The commenter is addressing not the
policy of adjusting payments for
nominal case-mix increases, but rather,
how CMS implements this policy; that
is, the methodology CMS uses for
determining the level of nominal casemix increase. While we do not believe
we are required to subject our exact,
final calculations regarding the increase
to public comment, it is also important
to note that our final methodology
clearly was an outgrowth of the
proposed rule. The proposed rule
included a detailed analysis of various
kinds of data, such as an extensive
review of the content of changes in
OASIS instructions, a review of changes
in the frequencies of severity levels of
the case-mix system, and a detailed
presentation of how OASIS items other
than those used for case-mix frequently
changed little, if at all. We also
discussed the pattern of change in
functional items, showing that for a
number of items, some changes
occurred at the high-functioning end,
while the worst-functioning levels
didn’t increase in the population. There
was a similar analysis of wound item
changes. Our interpretation of the
totality of the data was that real casemix did not materially change since the
IPS baseline. We also identified a large
increase in post-surgical patients with
their traditionally lower case-mix index.
However, we made an adjustment to our
estimate of case-mix change to account
for the change in the composition of the
home health industry on account of the
exit of some hospital-owned agencies.
These details enabled the home health
industry to analyze our proposed
methodology and provide comments
suggesting specific types of changes in
patient acuity that could help to explain
identified changes in home health casemix. For the final rule, we enhanced our
formal estimate of case-mix change,
which we had statistically adjusted to
account for change in the presence of
hospital-owned agencies in the
industry, with a methodology that
statistically adjusted for multiple
factors, including the types of factors
mentioned by commenters. Application
of this model allowed us to
simultaneously ‘‘subtract’’ from the
growth in the national case-mix index
the effects of a multitude of factors
besides the change in hospital-owned
agencies. Additionally, in the May 4,
2007 proposed rule (72 FR 25395) we
indicated that our analysis for the final
rule would be updated to include 2005
data.
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Specifically, for the final rule, we
updated the case-mix index and some of
the statistical data (e.g., average
resources per episode) to include 2005
data. We also added analyses focusing
on certain types of patients, including
those mentioned in public comments on
the proposal (e.g., knee replacement
patients). Further, as just discussed in
the paragraph above, we added results
from a multivariate model of case-mix
that isolated real case-mix change
between the HH IPS baseline and 2005.
The newly added data and the model
responded to comments that cited
circumstances of particular types of
patients and/or sought additional types
of evidence. These added data and
analyses were made in response to the
proposed rule comments. The data and
information added for the final rule,
along with the entire array of evidence
we presented in the proposed and the
final rule are the bases for the
identification of nominal case-mix
change.
Comment: Some commenters focused
on the finding that only 8 percent of the
case-mix change from 2000 to 2005 was
real. These commenters recommended
that CMS start with the assumption that
all case-mix change is real, and only
consider the amount that could be
estimated as nominal to be unjustified.
Another commenter pointed to CMS’
assertion that ‘‘real’’ case-mix increased
prior to implementation of the HH PPS
(prior to September 2000) and argued
that this fact demonstrates that it was
unreasonable for CMS to assume that
none of the change after that point was
real.
Commenters suggested that case-mix
has increased due to several factors,
including earlier discharges from
general acute hospitals, PPS changes
that provided incentives to treat higheracuity patients, and other post-acute
care regulations issued by CMS (such as
the inpatient rehabilitation ‘‘75%
Rule’’), which diverts more medically
complex patients to homecare. One
commenter urged CMS to defer any
adjustment for case-mix change and to
perform an analysis that accounted for
these factors.
Response: The predictive model
isolated 8.03 percent of the overall 12.78
percent increase in case-mix as real,
resulting in an 11.75 percent nominal
increase in case-mix. We relied on those
results to arrive at the nominal case-mix
reductions ¥2.75 percent for 3 years
and ¥2.71 percent for the fourth year of
the phase-in. (Refer to Section III.B. of
this proposed rule for an update based
on analysis of data through 2007.) Thus,
our model allowed and presumed some
real case-mix change. The model data
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relied on claims data instead of OASIS
data (with the exception of one variable,
which described the patient’s living
situation), to avoid reliance on data
which we knew were subject to coding
changes such as those resulting from
educational improvements, changes in
OASIS instructions, and financial
incentives. The model takes into
account the total change between the
baseline and the follow-up year (2005)
in the sources of patients (hospital,
inpatient rehabilitation facility, and
skilled nursing facility). It also takes
into account total change in the types of
acute hospital problems and hospitalrecorded comorbidities experienced by
patients before they entered home
health care, total change in living
situation, and total change in patients’
Part A expenditures incurred in the 120
days leading up to the beginning of each
episode (expenditures were adjusted for
price increases). Length of stay is also
accounted for by summing the number
of inpatient days of various types.
Additionally, we added analyses
focusing on certain types of patients,
including those mentioned in public
comments on the proposal (e.g., knee
replacement patients).
Every predictive model has its
limitations; however, we believe the
model and data we used were the best
available for the purposes of measuring
case-mix in an unbiased manner. For
example, we relied on hospital claims
data instead of OASIS data (with the
exception of one OASIS variable), and
enhanced our calculation method to
include a multivariate approach to casemix measurement. For those patients
who were hospitalized before home
care, the model included whether the
hospitalization was surgical or medical,
and in many cases the model identified
the particular, detailed conditions that
were responsible for that hospital stay.
These additions to the model were
suggested by the industry in comments
on the proposed rule.
Moreover, we again note that the Abt
model was not the sole basis for the
final regulation provision on nominal
case-mix change. The basis for the final
provision was the entire array of
evidence we presented in the proposed
and the final rules. In addition, in the
May 4, 2007, proposed rule (72 FR
25362–25366) we noted data as well as
commentary from observers indicating
that therapy treatment plans were
sometimes ‘‘padded’’ to reach the tenvisit therapy threshold; we consider this
behavior a component of nominal casemix change, because therapy visits help
to determine the case-mix group.
In response to the comment that CMS
should have started with the
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assumption that all case-mix growth
was real, and then calculate what
portion, if any, was nominal, the model
did assess real case-mix using a variety
of Part A claims. We then compared the
model’s prediction of real case-mix with
the actual billed case-mix, determining
the calculated difference to be nominal.
The May 4, 2007, proposed rule put the
case-mix of the Medicare home health
population in historical perspective. It
described the changes affecting the
home health benefit since the Balanced
Budget Act of 1997 and cited MedPAC,
GAO and other literature findings that
the HH IPS had a strong impact on the
types of patients served. We compared
the case-mix index from the Abt
Associates study sample with the casemix index of the HH IPS baseline (1999–
2000), a comparison that suggested that
changes in real case-mix did occur as a
result of the HH IPS. Literature findings
(GAO, ‘‘Medicare Home Health Benefit:
Impact of Interim Payment System and
Agency Closures on Access to Services,’’
September 1998, GAO/HEHS–98–238)
describe an HH IPS incentive to admit
many different patients with short-term
or rehabilitation needs instead of
lengthy low skilled care needs. We did
not rule out that some of the change
during that period was nominal, in part
because the HH PPS proposed rule of
1999 probably affected provider
behavior.
Moreover, our analysis of changes in
resource use showed that resource use
stayed below the resource use level of
the HH IPS period for much of the
succeeding five years, casting doubt on
the commenters’ assertion that patient
acuity increased. Specifically, after the
IPS was implemented, we saw a decline
in visit use from 73 visits per person in
1997 to 42 visits per person in 1999.
The number of visits further decreased
under the HH PPS, decreasing to 37 in
2000, and 31 for each year 2001 through
2004.
Comment: A commenter believes that
CMS’s decision to implement these
payment reductions is unjustified and
flawed for two basic reasons: (1) There
have been actual changes in the home
health population; and (2) providers
have improved the accuracy of OASIS
coding. The commenter refers to
recently released data by Outcome
Concept Systems citing the average 2005
adjusted case-mix weight nationally and
in New York was approximately 1.15,
not 1.2361, as CMS asserts.
The commenter believes that the
average case-mix weight has changed
because CMS fails to consider therapy
as a patient characteristic and because
patients’ clinical severity has increased.
Furthermore, the commenter believes
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that the increase in patients’ clinical
needs is largely due to an inpatient
hospital payment system that has
created incentives for early discharge of
patients who require more care. The
result is a home health population with
higher acuity and more intense resource
needs. The commenter also states that
growth in Medicare Advantage plans
has shifted lower acuity patients out of
traditional Medicare, leaving higher
need and higher cost beneficiaries
within the traditional Medicare
program.
A commenter stated that current
OASIS data show that HHAs are
admitting increased numbers of
beneficiaries with: (1) Comorbidities
such as diabetes and obesity; (2)
abnormalities of gait; (3) wound
infections; (4) urinary incontinence; and
(5) increased cognitive function deficits.
The accumulative effect of these
admissions has necessitated increased
therapy services which have resulted in
higher clinical and functional scores in
case-mix weights. In addition, the
commenter believes that physical
therapy services were underutilized
during the HH IPS and at the onset of
the HH PPS because of lack of clinical
knowledge and understanding of best
practice standards. The delivery of
medical services in the home has
improved over recent years. This is
evident by implementation of quality
measures and outcomes data. Several
commenters believe that the increase in
average case-mix can be attributed fully
to an improvement in each agency’s
ability to correctly answer OASIS items
and increased emphasis on OASIS
validity by Quality Improvement
Organizations (QIO). Another
commenter stated that their agency has
experienced a change in the percentage
of orthopedic patients due to changes in
regulations for rehabilitation hospitals.
Response: In the May 4, 2007 HH PPS
proposed rule, we indicated that the
analysis of national case-mix would be
updated using 2005 data in that year’s
HH PPS final rule, and that the annual
adjustments for nominal case-mix
change would be modified accordingly.
As we have noted elsewhere,
improvements in coding do not
represent real case-mix changes, which
means that the Medicare program
arguably may have overpaid for some of
the services which were provided after
improvements in OASIS coding were
implemented. CMS subsequently
adjusted the standardized payment
amount to compensate for the nominal
change in case-mix used to pay claims
in the years following the introduction
of the PPS.
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We acknowledge that therapy
treatment services were used as a casemix characteristic in the case-mix
model, in the absence of sufficient
explanatory power from OASIS data
items to model resource use by
themselves. However, we found a
dramatic change in the distribution of
episodes according to the number of
therapy visits between the HH IPS
baseline period and the early years of
the HH PPS period, and the new
distribution has persisted. We continue
to believe that the change in this short
period is an indication of behavioral
change on the part of home health
agencies, and is not necessarily related
to real case-mix change. Moreover, the
distributional shift occurred in the
absence of convincing evidence from
various OASIS items that patients were
actually more impaired and sickly.
Furthermore, when we took account of
patient characteristics in the model of
real case-mix change, the results did not
support a large difference in patient
acuity.
We also note that the reporting of
more comorbidities by HHAs is not
clear evidence of change in patient
status, as it could be a result of
improvements in coding training alone.
In addition, changes in regulations
affecting rehabilitation hospitals are
represented in the case-mix change
model by the variables that measure the
source of admission.
To the extent that the home health
industry has accomplished
improvements in patient function
without adding significant resources to
the provision of care in home health
episodes, we understand this is likely
attributable to shifts in the service mix
provided within the episode, as well as
improved care practices. Again,
however, the situation does not
necessarily indicate a real change in
case-mix.
Without more detailed information
about their analysis, we are unable to
comment on the implication in the
statistic from Outcome Concept Systems
in New York State (as reported by the
commenter) that the average case-mix
rose only 1.15 as compared to 1.2361 in
CMS’s analysis. The average case-mix is
computed from an extremely large
representative sample of national home
health claims data. The commenter does
not provide information about the
method of adjustment, the conditions of
data-gathering, or the quality or source
of the data sources used by Outcome
Concept Systems.
Comment: A commenter stated that
CMS’ review of 20 percent of claims
(OASIS for 2004–2005) does not reflect
the patient characteristics in 2007, and
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it certainly does not reflect those
receiving services in 2010 and 2011.
Response: We based our proposals on
the latest statistically representative
data available, and those data were from
2005 at the time of the preparation of
the final regulation. We will continue to
update the data as they become
available.
Comment: A commenter stated that
CMS should look more closely at
specific agencies it suspects may be
upcoding and then seek financial
restitution from those that are ultimately
deemed to be following this practice.
Across-the-board cuts of this magnitude
are unwarranted at a time when the
home health industry should be
receiving additional support to serve an
expanding older population.
Response: As we stated in the CY
2008 HH PPS final rule (72 FR at
49837), we believe that it is more
appropriate to implement a nationwide
approach to the issue of a case-mix
change adjustment. An individual
agency approach would be
administratively burdensome and
difficult to implement. Policies to
address the identity of agencies in light
of changes to organizational structures
and configurations would need to be
developed. Furthermore, smaller
agencies might have difficulty in
providing accurate measures of real
case-mix changes because of their small
caseloads. Because the nominal increase
in case-mix grew significantly from
2003 to 2005 (8.7 percent to 11.75
percent), we spread out the schedule of
adjustments from 3 years to 4 years in
order to ameliorate the impact that
would have been felt by HHAs had we
decided to account for the entire 11.75
percent increase in case-mix over 3
years.
Comment: A commenter is concerned
that CMS has not correctly addressed
factors measuring the apparent ‘‘creep’’.
Additionally, the commenter states that
it was useful to have CMS clarify that
they had excluded LUPAs from the two
measurement bases utilized and that
fact raises an issue that CMS did not
address in the rule. When the original
HH PPS was proposed (October 1999)
and finalized (July 2000), CMS asserted
that it expected LUPA incidence, as
estimated by its actuaries, would be five
percent. Actual incidence has, since
implementation, averaged sixteen
percent of total reimbursements. Using
just a five percent rate of occurrence
resulted in every original HHRG
assigned a lower value than if CMS had
used, say, a fifteen percent rate of
incidence. Accordingly, the commenter
argues that home health agencies were
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under-compensated by approximately
11 percent for LUPA savings.
Response: While this comment is
outside the scope of the topic (the 4th
year reductions) which we solicited
comments on, we will briefly respond.
In the July 2000 final rule (65 FR
41162), we stated that the estimate of
the percentage of LUPA episodes was an
actuarial estimate, as were the estimates
of incidence of SCICs, PEPs, and
outliers. Our base episode payment rates
are derived using the best data available
at that time. The commenter is correct
that the actual number of LUPA
episodes is higher than our original
estimate. However, while it is true that
16 percent of episodes from the 1998
pre-PPS data analysis were shown to be
LUPA-type episodes (65 FR 41186), we
also provided reasoning in that
discussion as to why we believed actual
LUPA incidence under the HH PPS
would be lower. Granted, the incidence
of LUPAs did not drop to the level of
5 percent of the total number of
episodes as was originally estimated,
however the average actual incidence of
LUPAs is, and has always been
considerably lower than the 16 percent
suggested by the commenter. In fact,
data analysis shows us that the
incidence of LUPA episodes was first
measured at approximately 15.2 percent
of the total number of episodes and has
continued to decrease under the HH
PPS. Specifically, recent analysis of
home health claims shows that LUPA
episodes made up approximately 10.6
percent of the total number HH PPS
episodes in CY 2007.
Another important fact that should
not be lost, as part of this discussion, is
that while the incidence of LUPAs is
less than originally estimated, we note
that the average number of home health
visits provided per episode for nonLUPAs episodes is also lower than what
we originally estimated (65 FR 41171)
when we built the base payment rates
(21.16 vs 25.5 home health visits).
Hence, the national standardized 60-day
episode payment is currently based on
the delivery of significantly more home
health visits per episode (25.5) than is
currently being delivered (21.16).
It is also worth noting that the manner
in which the commenter appears to
arrive at their under-compensation of
payment percentage is by subtracting
the original estimate for LUPA episodes
of 5 percent from their inaccurate
estimate of 16 percent incidence of
LUPA episodes. In addition to the
commenters 16 percent being inaccurate
(as mentioned above), it is important to
point out that even in doing the math,
an inaccurate 16 percent minus 5
percent actually reflects that there is an
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11 percentage point difference between
the two, not an 11 percent undercompensation in payment as the
commenter suggests. Because the
incidence of LUPAs is considerably
lower than the 16 percent that the
commenter suggests, and the average
number of home health visits per
episode is far less than originally
estimated, HHAs have not been undercompensated by 11 percent, as the
commenter suggests.
Since the inception of the HH PPS, we
have monitored home health utilization
in preparing the refinements to the HH
PPS. We have always contended that it
would not be appropriate to address
single aspects of the system, as the
many pieces/aspects of the system
interact and there are causes and effects
that each has on one another.
Consequently, we have addressed those
issues for which we believed we had
adequate information, as a result of our
analysis in the CY 2008 HH PPS
proposed and final rules. In doing so, as
is generally done in a prospective
payment system, we decided not to
make retroactive adjustments for actual
utilization that differed from estimates.
III. Provisions of the Proposed Rule
A. Outlier Policy
1. Background
Section 1895(b)(5) of the Act allows
for the provision of an addition or
adjustment to the regular 60-day casemix and wage-adjusted episode
payment amount in the case of episodes
that incur unusually high costs due to
patient home health care needs. This
section further stipulates that total
outlier payments in a given year may
not exceed 5 percent of total projected
or estimated HH PPS payments. Section
1895(b)(3)(C) of the Act stipulates that
the standard episode payment be
reduced by such a proportion to account
for the aggregate increase in payments
resulting from outlier payments.
In the July 2000 final rule (65 FR
41189), we described and subsequently
implemented an HH PPS outlier policy
under which we reduce the standard
episode payment by 5 percent, and
target up to 5 percent of total projected
estimated HH PPS payments to be paid
as outlier payments. The July 2000 final
rule described a methodology for
determining outlier payments. Under
this system, outlier payments are made
for episodes whose estimated cost
exceeds a threshold amount. The
episode’s estimated cost is the sum of
the national wage-adjusted per-visit rate
amounts for all visits delivered during
the episode. The outlier threshold is
defined as the national standardized 60-
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day episode payment rate for that casemix group plus a fixed dollar loss (FDL)
amount. Both components of the outlier
threshold are wage-adjusted. The wageadjusted FDL amount represents the
amount of loss that an agency must
experience before an episode becomes
eligible for outlier payments. The wageadjusted FDL amount is computed by
multiplying the national standardized
60-day episode payment amount by the
FDL ratio, and wage-adjusting that
amount. That wage-adjusted FDL
amount is added to the HH PPS
payment amount to arrive at the wageadjusted outlier threshold amount. The
outlier payment is defined to be a
proportion of the wage-adjusted
estimated costs beyond the wageadjusted outlier threshold amount. The
proportion of additional costs paid as
outlier payments is referred to as the
loss-sharing ratio. The FDL ratio and the
loss-sharing ratio were selected so that
the estimated total outlier payments
would not exceed the 5 percent level.
We chose a value of 0.80 for the losssharing ratio, which is relatively high,
but preserves incentives for agencies to
attempt to provide care efficiently for
outlier cases. A loss-sharing ratio of 0.80
means that Medicare pays 80 percent of
the additional costs above the wageadjusted outlier threshold amount. A
loss-sharing ratio of 0.80 is also
consistent with the loss-sharing ratios
used in other Medicare PPS outlier
policies, such as inpatient hospital,
inpatient rehabilitation, long-term
hospital, and inpatient psychiatric
payment systems. In CY 2000, we
estimated that a FDL ratio of 1.13 would
yield estimated total outlier payments
that were projected to be no more than
5 percent of total HH PPS payments. As
discussed in the October 1999 proposed
rule (64 FR 58169) and the July 2000
final rule (65 FR 41189), the percentage
constraint on total outlier payments
creates a tradeoff between the values
selected for the FDL amount and the
loss-sharing ratio. For a given level of
outlier payments, a higher fixed dollar
loss amount reduces the number of
cases that receive outlier payments, but
makes it possible to select a higher losssharing ratio and therefore increase
outlier payments per episode.
Alternatively, a lower fixed dollar loss
amount means that more episodes
qualify for outlier payments but outlier
payments per episode must be lower.
Therefore, setting these two parameters
involves policy choices about the
number of outlier cases and their rate of
payment.
When the data became available, we
performed an analysis of CY 2001 home
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health claims data. This analysis
revealed that outlier episodes
represented approximately 3 percent of
total episodes and 3 percent of total HH
PPS payments. Additionally, we
performed the same analysis on CY
2002 and CY 2003 home health claims
data and found the number of outlier
episodes and payments held at
approximately 3 percent of total
episodes and total HH PPS payments,
respectively. Based on these analyses
and comments we received, we decided
that an update to the FDL ratio would
be appropriate.
To that end, for the October 22, 2004
HH PPS rate update for the CY 2005
final rule, we performed data analysis
on CY 2003 HH PPS claims data. The
results of that analysis indicated that a
FDL ratio of 0.70 was consistent with
the existing loss-sharing ratio of 0.80
and a projected target percentage of
estimated outlier payments of no more
than 5 percent. Consequently, we
updated the FDL ratio from the initial
ratio of 1.13 to an FDL ratio of 0.70. Our
analysis showed that reducing the FDL
ratio from 1.13 to 0.70 would increase
the percentage of episodes that qualified
for outlier episodes from 3.0 percent to
approximately 5.9 percent. A FDL ratio
of 0.70 also better met the estimated 5
percent target of outlier payments to
total HH PPS payments. We believed
that this updated FDL ratio of 0.70
preserved a reasonable degree of cost
sharing, while allowing a greater
number of episodes to qualify for outlier
payments.
Our CY 2006 update to the HH PPS
rates (70 FR 68132) updated the FDL
ratio from 0.70 to 0.65 to allow even
more home health episodes to qualify
for outlier payments and to better meet
the estimated 5 percent target of outlier
payments to total HH PPS payments.
For the CY 2006 update, we used CY
2004 home health claims data.
In our CY 2007 update to the HH PPS
rates (71 FR 65884) we again updated
the FDL ratio from 0.65 to 0.67 to better
meet the estimated 5 percent target of
outlier payments to total HH PPS
payments. For the CY 2007 update, we
used CY 2005 home health claims data.
In the CY 2008 final rule with
comment period, in the interest of using
the latest data and best analysis
available, we performed supplemental
analysis on the most recent data
available in order to best estimate the
FDL ratio. That analysis derived a final
FDL ratio of 0.89 for CY 2008.
In order to determine the appropriate
value for the FDL ratio for the CY 2009
rate update, in the November 3, 2008
HH PPS Rate Update for CY 2009 notice
(73 FR 65351), we performed an
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analysis using the most recent, complete
available data at the time (CY 2006),
applying a methodology similar to that
which we used to update the FDL ratio
in the CY 2008 HH PPS final rule. That
updated analysis projected that in CY
2009 we would expend an estimated
10.26 percent of total estimated HH PPS
payments in outlier payments, more
than twice our 5 percent statutory limit.
Our analysis also revealed that this
growth in outlier payments was
primarily the result of excessive growth
in outlier payments in a few discrete
areas of the country. We noticed
statistical anomalies in outlier payments
in terms of both high outlier dollars and
as a percentage of total HH PPS
payments, in areas such as Miami-Dade
Florida, where outlier payments to
providers far exceed the national
average and the 5 percent target for
outlier payments. Using similar analysis
to what was performed for the CY 2008
final rule with comment, we estimated
that we would need to raise our FDL
ratio from 0.89 to 2.71 for CY 2009 in
order for estimated outlier payments to
be no more than 5 percent of total HH
PPS payments. In addition, the size of
these statistical anomalies raised
concerns about the medical necessity of
the outlier episodes in some areas.
However, in our CY 2009 payment
update, we did not raise the FDL ratio
to 2.71, given the statistical outlier data
anomalies that we identified in certain
targeted areas, because program
integrity efforts, such as payment
suspensions for suspect HHAs, were
underway to address excessive, suspect
outlier payments that were occurring in
these areas. Instead, we maintained the
then-current (CY 2008) FDL ratio of 0.89
in CY 2009 while actions to remedy any
inappropriate outlier payments in these
target areas of the country were
effectuated.
2. Proposed Change to Target Outlier
Payment Percentage
For CY 2010 rulemaking, we have
expanded our outlier analysis. In
addition to assessing what FDL ratio
would most accurately achieve the 5
percent target of outlier payments as a
percentage of total HH PPS payments,
we also performed analyses to assess the
appropriateness of adopting a lower
target percentage of outlier payments to
total HH PPS payments. Some
commenters to our CY 2008 proposed
rule suggested that CMS should
consider targeting a lower percentage in
outlier payments to total estimated HH
PPS payments.
Commenters suggested that by
lowering the target outlier percentage to
total estimated HH payments, CMS
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could then return to the national
standardized 60-day episode payment
rate, a portion of that 5 percent which
was originally withheld from the rates
to fund the 5 percent of total estimated
HH PPS outlier payments. In our
response to the CY 2008 comments, we
described our concern that reducing the
target outlier percentage could risk
access to home care for high needs
patients. However, recent analysis of
more current data, specifically CY 2007
and CY 2008 data, suggests that a target
around that of 2.5 percent in outlier
payments to total estimated HH PPS
payments may be a more appropriate
target than 5 percent, while not risking
access to care for high needs patients.
Section 1895(b)(5) of the Act states that
the Secretary ‘‘may’’ provide for an
addition or adjustment to the payment
amount otherwise made in the case of
outliers. It goes on to say that if the
Secretary decides to provide such a
payment, that the total amount of the
additional payments or payment
adjustments may not exceed 5 percent
of the total payment projected or
estimated to be made under the
payment system. Consequently,
providing an addition or adjustment to
the payment amount for outliers is
optional and not statutorily required.
We performed an analysis of all
providers who receive outlier payments,
focusing our analysis on total HH PPS
payments, total outlier payments,
number of episodes, number of outlier
episodes, and location of provider. As
discussed below under ‘‘Proposed
Outlier Cap Policy’’, our analysis
incorporates a proposed 10 percent cap
on outliers and looks at outlier
payments as a percentage of total HH
PPS payments with that 10 percent cap
in place. In our analysis of 2007 data,
after implementing the 10 percent cap,
outlier dollars accounted for
approximately 2.1 percent of total HH
PPS payments.
Additionally, we performed a separate
analysis on a major association of home
health agencies who claim to be safetynet providers, serving sicker, more
costly patients. The average outlier
payment to these agencies is also under
2 percent. Therefore, we believe a target
of less than 5 percent for outlier dollars
as a percentage of total estimated HH
PPS payments is appropriate. However,
past years’ data trends show us that
outlier payments will likely continue to
grow. Consequently, we propose to
change our target percentage of outlier
payments from 5 percent to
approximately 2.5 percent of total
estimated HH PPS payments.
Currently, we reduce the national
standardized 60-day episode payment
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rates, the national per-visit rates, the
LUPA add-on amount, and the NRS
conversion factor by 5 percent in order
to create an outlier pool that
accommodates estimated outlier
payments of 5 percent of total HH PPS
payments. Targeting the percentage of
outlier payments at approximately 2.5
percent will allow us to create a smaller
outlier pool and return the remaining
2.5 percent to the HH PPS rates. We
would retain a 2.5 percent reduction to
the national standardized 60-day
episode rates, the national per-visit
rates, the LUPA add-on payment
amount, and the NRS conversion factor
to fund the proposed target of
approximately 2.5 percent of total
estimated HH PPS payments in outlier
payments, adhering to the statutory
requirement in Section 1895(b)(3) of the
Act.
3. Proposed Outlier Cap Policy
Although program integrity efforts
associated with excessive outlier
payments continue in targeted areas of
the country, we continue to be at risk of
exceeding the 5 percent statutory limit
on estimated outlier expenditures.
Therefore, our recent analysis also
focused on whether a broader policy
change to our outlier payment policy
might also be warranted, to mitigate
possible billing vulnerabilities
associated with excessive outlier
payments, and to adhere to our statutory
limit on outlier payments.
We also considered eliminating
outlier payments altogether and
restoring the 5 percent, originally taken
out of the national standardized 60-day
episode rates, the national per-visit
rates, the LUPA add-on payment
amount, and the NRS conversion factor
to pay for the existing outlier policy,
back into the HH PPS rates. Eliminating
outlier payments would simplify
payments to HHAs and remove the
vulnerability associated with
inappropriate outlier payments.
However, we are concerned that
eliminating outlier payments to HHAs
could result in denying added
protection to HHAs that historically
treat sicker, more costly patients.
In attempts to better estimate outlier
payments as a percentage of total HH
PPS payments and to mitigate
vulnerabilities associated with
inappropriate outlier payments, we also
looked into options that would impose
an outlier cap, at the agency level, such
that in any given year, an individual
HHA would receive no more than a set
percentage of its total HH PPS payments
in outlier payments. We performed
extensive analyses to model the impact
to HHAs of a variety of percent caps in
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outlier payments. A primary focus of
this analysis was to identify HHAs
which would be representative of the
types of agencies we are most concerned
about disadvantaging with an outlier
policy that included an outlier cap at
the agency level. Our analysis revealed
that a 10 percent agency cap in outlier
payments would mitigate potential
inappropriate outlier billing
vulnerabilities while minimizing the
access to care risk for high needs
patients.
We used CY 2007 claims data to
perform a detailed impact analysis. We
identified 1137 HH agencies whose
outlier payments exceeded 10 percent of
their total HH PPS payments in CY
2007. However, we excluded 700 of
these agencies from the impact analysis,
because these agencies received sizeable
outlier payments (totaling at least
around $100,000), had high percentages
(at least around 30 percent) of outlier
payments to total HH PPS payments,
and were located in the counties in FL,
TX and CA where we believe possible
program integrity issues had been
identified.
We targeted our in-depth impact
analysis to the remaining 437 agencies,
about 5 percent of all Medicare home
health agencies. We analyzed these
agencies as a group and individually.
Our analysis focused on total HH PPS
payments, total outlier payments,
number of episodes, number of outlier
episodes, percentage reductions in
payments if a 10 percent outlier cap
were imposed, and location. Analyzing
CY 2007 data, these 437 agencies would
have experienced about a 10 percent
decrease in their total HH payments if
an outlier cap of 10 percent, at the
agency level, were imposed. As we
looked closely at the individual 437
agencies, we excluded additional
agencies for a number of reasons.
Specifically, we excluded 70 agencies
that had fewer than 20 Medicare HH
episodes, believing that Medicare
beneficiaries account for such a small
part of their business that they are not
representative of the types of agencies
we are most concerned about
disadvantaging with an outlier cap
policy.
We excluded an additional 197
agencies because they are also located in
the counties identified as experiencing
program integrity problems. While these
197 agencies did not receive exorbitant
outlier payments, their relatively high
outlier payment percentages to total
agency HH PPS payments led us to
suspect inappropriate payments. We
believe that the remaining 170 agencies,
representing less than 2 percent of all
Medicare home health agencies, are
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representative of the types of agencies
we are most concerned about
disadvantaging with an outlier policy
that included a 10 percent cap at the
agency level.
This analysis showed that almost all
of the 170 agencies are in urban areas,
with only 16 agencies in rural areas. The
total number of episodes that resulted in
outlier payments is 4,497, about 15
percent of their total episodes. The total
HH PPS payments for these agencies
equaled about $85 million in CY 2007.
The total outlier payments for these
agencies equaled $14.4 million,
representing an average of about 17
percent of their total HH PPS payments.
The total amount of payments that
would be lost by these providers due to
a 10 percent cap would be $6.6 million,
representing an average of
approximately 7.9 percent of their total
HH PPS payments. However, because
most affected agencies are in urban
areas, and there is not an access
problem with regard to receiving home
health services in urban areas, we do
not expect that an outlier cap of 10
percent at the agency level would result
in any access to care issues.
Additionally, we also performed a
separate analysis of the major home
health agency association which claims
to service a sicker, more costly
population. In 2007, only one of these
agencies exceeded 10 percent of its total
episode payments in outlier payments,
receiving approximately 15 percent of
its total HH PPS payments in outlier
payments.
Finally, we performed an analysis of
the impact that imposing an outlier cap
of 10 percent at the agency level would
have on total outlier payments as a
percentage of total HH PPS payments.
The FDL ratio for CY 2007 was 0.67. In
simulating for 2010 using 2007 data,
imposing an outlier cap of 10 percent at
the agency level, we estimate that we
would pay approximately 2.32 percent
of total HH PPS payments in outlier
payments.
Therefore, to mitigate possible billing
vulnerabilities associated with excessive
outlier payments, and to adhere to our
statutory limit on outlier payments, we
propose to implement an agency level
outlier cap such that in any given
calendar year, an individual HHA
would receive no more than 10 percent
of its total HH PPS payments in outlier
payments. Additionally, we propose to
reduce the FDL ratio to 0.67 for CY
2010. This combination of a 10 percent
agency level outlier cap, and reduced
FDL ratio of 0.67, and allowing for
future growth in outlier payments,
results in a projected target outlier
payment outlay of approximately 2.5
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percent of total HH PPS payments in
outlier payments.
Our analysis demonstrates that
approximately 2 percent of HH agencies
may experience an average 7.9 percent
decrease in payments. This decrease
will be mitigated by a 2.5 percent
increase in the HH PPS rates, as a result
of lowering the outlier pool from 5
percent to 2.5 percent. However, these
impacts are averages. Some agencies
that legitimately serve a sicker
population may experience a larger
decrease. Because MedPAC reported in
their January 2009 public meeting
(https://www.medpac.gov/transcripts/
0108-0109MedPAC.final.pdf) that
Medicare beneficiaries have access to an
adequate number of HHAs, we do not
believe this policy will result in access
to home care issues for high needs
patients.
As discussed in the CY 2009 HH PPS
Update notice (73 FR 65357), past
experience has shown that outlier
payments have been increasing as a
percentage of total payments from 4.1
percent in CY 2005, to 5.0 percent in CY
2006, to 6.4 percent in CY 2007.
Analysis at the time of the above notice
indicated that we could expect outlier
payments as a percentage of total HH
PPS payments to be approximately 8.1
percent of total payments in CY 2008,
and increase to approximately 10.26
percent in CY 2009. Given that
predicted trend in outlier payments, we
estimated that we would have had to
raise our FDL ratio from 0.89 to 2.71 for
CY2009 in order to ensure that
estimated outlier payments would be no
more than 5 percent of total HH PPS
payments. We believe that it is the high
suspect outlier payments in suspect
areas of the country that cause existing
data analysis to seemingly require such
a high FDL ratio in order to meet the
target 5 percent of total HH PPS
payments.
Because outlier payments continues
to grow, and those outlier payments as
a percentage of total HH PPS payments
already exceed the statutory limit,
absent our proposed outlier cap of 10
percent at the agency level, we would be
required to raise the FDL ratio to a level
much higher than either the current 0.89
or the proposed 0.67, and doing so
would deleteriously affect agencies
providing legitimate care to home health
beneficiaries. We do not believe that
raising the FDL ratio to such a high
level, making it even harder for
legitimate episodes to qualify for outlier
payments, is the appropriate policy,
especially given the fact that we believe
it is these high suspect outlier payments
in suspect areas of the country that are
causing outlier payments as a
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percentage of total HH PPS payments to
continue to increase to levels beyond
the existing 5 percent target. Conversely,
we believe that our proposed outlier
policy that includes a 10 percent cap on
outlier payments at the agency level, in
concert with a new 2.5 percent outlier
pool (as opposed to the existing 5
percent outlier pool), and returning 2.5
percent back into the national
standardized 60-day episode rates, the
national per-visit rates, the LUPA addon payment amount, and the NRS
conversion factor, with a 0.67 FDL ratio,
would be the appropriate policy at this
time. We expect the new outlier policy
to curtail approximately $340 million,
in CY 2010, in what we believe to be
inappropriate outlier payments.
Finally, CMS will continue to monitor
the trends in outlier payments and these
policy effects. Specifically, CMS plans
to analyze overall national spending on
outlier payments relative to the new 2.5
percent outlier pool by geographic area
and provider type. CMS also plans on
looking at outlier payments, per HHA,
relative to the proposed 10 percent cap
on outlier payments at the agency level
by geographic area and provider type.
So far as activities related to high
suspect outlier payments, CMS is
continuing with program integrity
efforts including possible payment
suspensions for suspect agencies. If we
are unable to see measurable
improvements with respect to suspected
fraudulent billing practices as they
relate to HHA outlier payments, CMS
may consider eliminating the outlier
policy entirely in future rulemaking.
Proposed implementation approach
to a 10 percent agency level outlier cap.
CMS envisions the proposed 10
percent cap on outlier payments at the
agency level would be managed by the
claims processing system. For each HH
provider, for a given calendar year, the
claims processing system would
maintain a running tally of YTD total
HH PPS payments and YTD actual
outlier payments. The claims processing
system would ensure that each time a
claim for a provider was processed; YTD
outlier payments for that calendar year
could never exceed 10 percent of YTD
total HH PPS payments for that provider
for that calendar year. As a provider’s
claims (RAPs and final claims) were
processed and YTD HH PPS payments
for that calendar year increased
throughout the course of the year, the
claims processing system would be
triggered to pay outlier payments,
adjusting prior final claims by paying
previously unpaid outlier payments, as
the YTD total HH PPS payments for that
calendar year allowed, never exceeding
10 percent of total YTD HH payments
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39445
for that calendar year. In cases where a
provider submitted a claim with an
outlier payment early in the year when
YTD total HH PPS payments for that
calendar year were low, outlier
payments would be delayed until YTD
total HH PPS payments for that calendar
year reached a level to pay the outlier
payment.
More specifically, instead of a given
claim being readjusted several times as
total HH PPS payments increase, but not
enough to pay an entire outlier payment
on a given claim, we are considering a
process by which an outlier payment on
a previous claim would not be adjusted
until total HH PPS payments for that
calendar year were such that the entire
outlier payment could be made without
exceeding 10 percent of total HH PPS
payments for a particular HHA for that
calendar year. Doing so would avoid not
only the cost of possible multiple
adjustments to a given claim, but would
also simplify the process making
adjustments easier to track and
understand. We solicit comments on
these proposed outlier policy changes.
B. Case-Mix Measurement Analysis
In the CY 2008 HH PPS final rule with
comment period, we stated that we
would continue to monitor case-mix
changes in the HH PPS and to update
our analysis to measure change in casemix, both nominal and real. We have
continued to monitor case-mix changes
and our latest analysis supports the
payment adjustments which we
implemented in the CY 2008 HH PPS.
We have updated our examination of
five conditions that commenters on our
case mix change adjustment suggested
indicate a real case mix change. This
analysis was originally summarized as
Table 8 in the August 29, 2007, final
rule. The updated results (see Table 1
below) show that the shares of episodes
preceded by a hospital discharge for hip
fracture, congestive heart failure, and
cerebrovascular accident have
continued to decline since the IPS
baseline. The percent share for hip and
knee replacements rose and then began
to decline slightly around the middle of
the time series shown. (Note: data since
2005 for joint replacements differ
slightly from the original Table
regarding the five conditions published
in the August 29, 2007, Final Rule
because we changed our methodology to
recognize several ICD–9 procedure code
changes that affected joint
replacements). The increase in joint
replacements as a proportion of all
episodes was not sustained at the 2004–
2005 level by the end of the period,
perhaps because whatever mechanism
operated to cause the growth lost some
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of its strength, or perhaps because even
faster growth occurred in other types of
episodes (such as outlier episodes and/
or later episodes).
Our interpretation of these trends in
the Aug. 29, 2007, Final Rule was that,
with the possible exception of knee
replacements, the trends observed at
that time were not clearly indicative of
a more-severe case mix. If anything, the
sustained downward trend for hip
fracture, CHF, and CVA suggest that the
burden of these diseases on home health
providers is lighter now than it used to
be. For hip replacement, the share
appears to have ended up (thus far)
below the share of such patients during
the IPS period. For knee replacements,
it appears that shares may have ceased
climbing. Our interpretation of the knee
replacement trend in the August 29,
2007, final rule was that this category
constituted a small share, that the Abt
case mix change model took account of
it, and that based on the model results
the knee replacement change apparently
was not enough to move the estimate of
real case mix change very much. The
updated data now suggest that knee
replacements leveled off as a share of
total episodes since around 2005. As a
result, we have not changed our
interpretation of the trends in episode
shares for these five conditions.
Our estimates of average number of
days from hospital discharge to entrance
into home health were an attempt to
examine the hypothesis that patients
were entering home health in a more
sickly condition. We did not see any
evidence of that for the three medical
conditions; the number of days prior to
entering home health exhibits no clear
trend. For joint replacements, as in the
earlier analysis, we saw a continuing
decline in the average number of days
prior to entering home health. These
patients may present in a more sickly
condition than was the case under IPS,
but they are no longer a growing share
of the HH caseload and represent
slightly less than 4% of the episodes.
Combined with the downward or
stabilizing trends in the shares for all
five conditions, the shortening of the
time period to admission for the two
joint replacement conditions does not
suggest an overall more-acute case mix,
at least as indicated by these five
conditions. As we noted in the CY 2008
final rule, the Abt Associates model
simultaneously takes account of all of
the kinds of patients incurring home
health episodes, including the five
conditions detailed here.
TABLE 1
FY
2000
Hip fracture ..........................................
Congestive heart failure ......................
Cerebrovascular accident ....................
Hip replacement ..................................
Knee replacement ...............................
pct share ...........................................
days prior to entering .......................
pct share ...........................................
days prior to entering .......................
pct share ...........................................
days prior to entering .......................
pct share ...........................................
days prior to entering .......................
pct share ...........................................
days prior to entering .......................
CY
2001
CY
2002
CY
2003
CY
2004
CY
2005
CY
2006
CY
2007
CY
2008*
0.82
7.19
3.31
3.38
1.52
4.32
1.47
6.45
1.89
5.40
0.83
7.12
3.06
3.28
1.45
4.23
1.65
6.32
2.20
5.30
0.75
7.17
2.96
3.35
1.40
4.21
1.64
6.26
2.31
5.42
0.73
7.21
2.89
3.33
1.29
4.29
1.59
6.29
2.44
5.19
0.70
7.30
2.72
3.36
1.15
4.20
1.63
5.92
2.59
4.93
0.62
7.10
2.45
3.40
1.03
4.32
1.49
5.56
2.74
4.60
0.56
7.08
2.23
3.40
0.92
4.31
1.38
5.30
2.62
4.25
0.50
7.20
1.95
3.53
0.85
4.42
1.33
5.01
2.49
3.99
0.48
7.00
2.06
3.55
0.82
4.59
1.27
4.78
2.64
3.71
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Note: Based on a 10% beneficiary HH user sample.
*CY 2008 data for first quarter of the year only.
In the course of updating the estimate
of real case-mix change, our analysis
contractor, Abt Associates, discovered a
number of errors in data handling for
the case-mix change model. The
analysis files included relatively small
numbers of records that should have
been excluded, and relatively small
numbers that were dropped but that
should have been included. Another
error was in the handling of missing
data for one of the key variables in the
regression model (patient’s living
situation); data were not recognized as
missing and were therefore miscoded.
Methodologically, an improvement was
implemented to ensure that the
observation period for the IPS baseline
sample was consistent with the
observation period for the PPS sample
(2005).
Abt Associates made corrections in
response to each problem identified.
The only significant change in results
came from correcting the handling of
missing data. Correcting this error (by
imputing values for cases with missing
data) caused an increase in the
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estimated real change in case-mix. Our
original estimate, published in the CY
2008 HH PPS final rule (72 FR 49842),
was that about 8.03 percent of the
increase in case-mix between the IPS
baseline (1999–2000) and 2005 was due
to actual changes in patient
characteristics (i.e., ‘‘real’’). After this
correction, the real case-mix change
estimate for the same period increased
by several percentage points. Had the
data corrections and improvements been
implemented in the CY 2008 HH PPS
final rule, our estimate of real case-mix
change, as a percentage of total case-mix
change, would have been approximately
14.15 percent as opposed to 8.03
percent (73 FR 49833, 49842). Updating
that analysis, using PPS data from 2006,
our best estimate of real case-mix
change, as a percentage of total case-mix
change, is slightly lower (11.45 percent).
This is due to the combination of
continued strong annual growth
between 2005 and 2006 in the average
case-mix weight, along with little
change between 2005 and 2006 in
patient characteristics.
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We have further updated our case-mix
analysis, for this rule, using PPS data
from 2007. That analysis indicated a
15.03 percent increase in the overall
observed case-mix since 2000. We next
determined what portion of that
increase was associated with a real
change in the actual clinical condition
of home health patients. As was done
for the CY 2008 final rule, using Abt
Associates’ 6-phase model, we
examined data on demographics, family
support, pre-admission location, clinical
severity, and non-home health Part A
Medicare expenditure data to predict
the average case mix weight for 2007. As
such, our best estimate is that
approximately 9.77 percent of the 15.03
percent increase in the overall observed
case-mix between the IPS baseline and
2007 is real, that is, due to actual
changes in patient characteristics.
The estimate of real case-mix change
continues to decrease for a number of
reasons: First, because the nominal
change in case mix continues to grow,
real case-mix as a percentage of the total
change/increase in case-mix becomes
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less. With each successive sample,
beginning with 2005 data (in the CY
2008 final rule), the predicted average
national case-mix weight is moving very
little because the variables in the model
used to predict case-mix are not
changing much. At the same time, the
actual average case-mix continues to
grow steadily. Thus, the gap between
the predicted case-mix value, which is
based on information external to the
OASIS, and the actual case-mix value,
grows with each successive sample.
Consequently, as a result of this
analysis, CMS recognizes that a 13.56
percent nominal increase (15.03 ¥
(15.03 × 0.0977)) in case-mix is due to
changes in coding practices and
documentation rather than to treatment
of more resource-intensive patients.
To compensate for this growth over
four years, an increase of this magnitude
(13.56 percent), had it existed when the
CY 2008 final rule was published,
would have implied reductions in the
rates of 3.13 percent per year for 4 years
(CY 2008–CY 2011). We stated in our
CY 2008 HH PPS proposed and final
rules that we might find it necessary to
adjust the offsets as new data became
available. Given that we have adjusted
the rates for two consecutive years by
¥2.75 percent in each year, based on
2007 data available for this proposed
rule, if we were to account for the
residual increase in nominal case-mix
over the next two years, maintain our
existing policy of a ¥2.75 percent casemix change in 2010, and account for the
residual increase in nominal case-mix in
2011, we estimate that the percentage
reduction in the rates for nominal casemix change in 2011 would be 4.26
percent. If we were to account (in the
final rule) for the full residual increase
in nominal case-mix in CY 2010, we
estimate that the percentage reduction
to the national standardized 60-day
episode rates and the NRS conversion
factor would be 6.89 percent. Similarly,
if we were to account (in the final rule)
for the full residual increase in nominal
case-mix in two years, we estimate that
the percentage reduction to the national
standardized 60-day episode payment
rates and the NRS conversion factor
would be 3.51 percent, per year, in CY
2010 and CY 2011. We are planning to
move forward with our existing policy,
as implemented in the August 22, 2007
HH PPS Refinement and Rate Update for
CY 2008 final rule with comment, of
imposing a 2.75 percent reduction to the
national standardized 60-day episode
rates and the NRS conversion factor for
CY 2010. We are accepting comments
on the reduction percentages. We will
continue to monitor any future changes
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in case-mix as more current data
become available. Given the continued
growth in nominal case-mix, we expect
to revise, upward, the 2.71 percent
reduction to the national standardized
60-day episode rates and the NRS
conversion factor for CY 2011 in next
year’s rule. Analysis in next year’s rule
will update the measure of the nominal
increase in case-mix and compute the
appropriate percent reduction to the
national standardized 60-day episode
rates and the NRS conversion factor to
account for that increase.
We may update the above-mentioned
analysis for the final rule in a number
of ways. We have been assembling data
to enhance the Abt model to take into
account factors that might have been
unmeasured in the original model. We
plan to introduce diagnostic summaries
created from a broader sweep of the
patient’s claims history, including Part
B claims. Specifically, we may add
information from the Medicare
Hierarchical Coexisting Condition
(HCC) data file to identify diagnoses for
home health users and their impact on
the predicted real case-mix weight. The
HCC system is used for risk adjustment
in Part C of the Medicare program. CMS
annually produces an HCC record
containing diagnosis flags and an HCC
‘‘score’’ for every beneficiary. The
diagnoses used for HCC risk adjustment
come from hospital inpatient claims
(primary and secondary diagnoses)
(including rehabilitation, long-term, and
psychiatric hospitals), hospital
outpatient department claims, physician
claims, and claims from clinically
trained nonphysicians such as
podiatrists, psychologists, and physical
therapists. Until now, diagnostic
information for the Abt model came
from Part A inpatient claims only.
Commenters have suggested that we
take into account changes in the role of
managed care in the Medicare program.
These commenters stated that growth in
managed care enrollment implies a
generally sicker population remaining
in the fee-for-service program; a change
in home health users’ general health
status might be reflected in OASIS items
that determine the episode’s HHRG.
Medicare managed care began to grow
modestly in 2004, but growth
accelerated in 2006. Therefore, another
enhancement that we may test is a
variable measuring managed care
penetration in the beneficiary’s area;
this variable is intended to capture any
possible effects of attrition from FFS
Medicare due to growing enrollment in
Medicare Advantage plans. Attrition
might result in the exit of relatively
healthy beneficiaries from the FFS
program, leaving a population in FFS
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39447
whose average health status worsens
over time. It is only the FFS population
that is at risk for home health benefit
use in the HH PPS.
C. Proposed CY 2010 Rate Update
1. The Home Health Market Basket
Update
Section 1895(b)(3)(B) of the Act
requires for CY 2010 that the standard
prospective payment amounts be
increased by a factor equal to the
applicable home health market basket
update for those HHAs that submit
quality data as required by the
Secretary.
The proposed HH PPS market basket
update for CY 2010 is 2.2 percent. This
is based on Global Insight Inc.’s first
quarter 2009 forecast, utilizing historical
data through the fourth quarter 2008. A
detailed description of how we derive
the HHA market basket is available in
the CY 2008 Home Health PPS proposed
rule (72 FR 25356, 25435).
2. Home Health Care Quality
Improvement
Section 1895(b)(3)(B)(v)(II) of the Act
requires that ‘‘each home health agency
shall submit to the Secretary such data
that the Secretary determines are
appropriate for the measurement of
health care quality. Such data shall be
submitted in a form and manner, and at
a time, specified by the Secretary for
purposes of this clause.’’ In addition,
section 1895(b)(3)(B)(v)(I) of the Act
dictates that ‘‘for 2007 and each
subsequent year, in the case of a home
health agency that does not submit data
to the Secretary in accordance with
subclause (II) with respect to such a
year, the home health market basket
percentage increase applicable under
such clause for such year shall be
reduced by 2 percentage points.’’ This
requirement has been codified in
regulations at § 484.225.
CMS published information about the
quality measures in the Federal Register
as a proposed rule on May 4, 2007 (72
FR 25449, 25452) and as a final rule
with comment period on August 29,
2007 (72 FR 49861, 49864). We
proposed and made final, the decision
to use a subset of OASIS data that is
publicly reported on Home Health
Compare as the appropriate measure of
home health quality.
Reporting these quality data has also
required the development of several
supporting mechanisms such as the
HAVEN software, used to encode and
transmit data using a CMS standard
electronic record layout, edit
specifications, and data dictionary. The
HAVEN software includes the required
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OASIS data set that has become a
standard part of HHA operations. These
early investments in data infrastructure
and supporting software that CMS and
HHAs have made over the past several
years in order to create this quality
reporting structure have been successful
in making quality reporting and
measurement an integral component of
the HHA industry.
Development and selection of home
health quality measures is a constant
and dynamic process based on the
characteristics and needs of the
population served. A total of 54 quality
measures are currently reported to home
health agencies for use in their
Outcomes Based Quality Improvement
(OBQI) activities. Every three years a
selection of Home Health quality
measures are submitted to the National
Quality Forum (NQF) for consideration
and endorsement through their
consensus process. A subset of measures
are chosen by CMS for public reporting
on the Home Health Compare Web site.
The following twelve measures are
currently publicly reported:
• Improvement in ambulation/
locomotion,
• Improvement in bathing,
• Improvement in transferring,
• Improvement in management of
oral medications,
• Improvement in pain interfering
with activity,
• Acute care hospitalization,
• Emergent care,
• Discharge to community,
• Improvement in Dyspnea,
• Improvement in urinary
incontinence,
• Improvement in status of surgical
wounds, and
• Emergent care for wound infections,
deteriorating wound status.
Accordingly, for CY 2010, we propose
to continue to use submission of OASIS
data and the quality measures that are
publicly reported on Home Health
Compare to meet the requirement that
the HHA submit data appropriate for the
measurement of health care quality.
Continuing to use the specified
measures from the OASIS instrument
for purposes of measuring health care
quality ensures that providers will not
have an additional burden of reporting
through a separate mechanism, and that
the costs associated with the
development and testing of a new
reporting mechanism can be avoided.
We are proposing for CY 2010 to
consider OASIS assessments submitted
by HHAs to CMS in compliance with
HHA conditions of participation for
episodes beginning on or after July 1,
2008 and before July 1, 2009 as fulfilling
the quality reporting requirement for CY
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2010. This time period would allow 12
full months of data collection and
would provide us the time necessary to
analyze and make any necessary
payment adjustments to the payment
rates in CY 2010 and each year
thereafter. We propose to reconcile the
OASIS submissions with claims data in
order to verify full compliance with the
quality reporting requirements in CY
2010 and each year thereafter on an
annual cycle July 1 through June 30 as
described above.
As set forth in the CY 2008 final rule
with comment period (72 FR 49863),
agencies do not need to submit quality
measures for reporting purposes for
those patients who are excluded from
the OASIS submission requirements
under the Home Health Conditions of
Participation (CoP). The conditions of
participation (42 CFR 484.200–484.265)
that require submission also provide for
exclusions from this requirement if:
• Those patients are receiving only
non-skilled services,
• Neither Medicare nor Medicaid is
paying for home health care (patients
receiving care under a Medicare or
Medicaid Managed Care Plan are not
excluded from the OASIS reporting
requirement),
• Those patients are receiving pre- or
post-partum services, or
• Those patients are under the age of
18 years.
As set forth in the CY 2008 final rule
with comment period (72 FR 49863),
agencies that certify on or after May 31
of the preceding year involved are
excluded from any payment penalty for
quality reporting purposes for the
following CY. Therefore, HHAs that are
certified on or after May 1, 2009 are
excluded from the quality reporting
requirement for CY 2010 payments
since data submission and analysis will
not be possible for an agency certified
this late in the reporting time period. At
the earliest time possible after obtaining
the CMS Certification Number (CCN),
reporting would be mandatory. These
exclusions only affect quality reporting
requirements and do not affect the
HHA’s reporting responsibilities under
the CoP.
HHAs that meet the reporting
requirements would be eligible for the
full home health market basket
percentage increase. HHAs that do not
meet the reporting requirements would
be subject to a 2 percent reduction to the
home health market basket increase. We
provide the proposed payment rates in
Tables 1, 2, and 3.
Section 1895(b)(3)(B)(v)(III) of the Act
further requires that ‘‘[t]he Secretary
shall establish procedures for making
data submitted under subclause (II)
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available to the public. Such procedures
shall ensure that a home health agency
has the opportunity to review the data
that is to be made public with respect
to the agency prior to such data being
made public.’’ To meet the requirement
for making such data public, we propose
to continue using the Home Health
Compare Web site, which lists HHAs
geographically. Currently, the Home
Health Compare Web site lists 12
quality measures from the OASIS set as
described above. The Home Health
Compare Web site is located at the
following Web address: https://www.
medicare.gov/HHCompare/Home.asp.
Each HHA currently has pre-publication
access (through the CMS contractor) to
its own quality data (which the
contractor updates periodically). We
plan to continue this process, to enable
each agency to view its quality measures
before public posting of data on Home
Health Compare.
CMS is requesting OMB approval to
modify the OASIS data set. This process
is in the final stages of OMB clearance.
Pending OMB approval, CMS intends to
implement the use of the OASIS–C
(Form Number CMS–R–245 (OMB#
0938–0760)) on January 1, 2010. This
revision to the current OASIS version
B–1 has undergone additional testing as
part of the information collection
request approved under OMB control
number 0938–1040. As part of the OMB
approval process, the revision to the
current OASIS version was also
distributed for public comment and
other technical expert recommendations
over the past few years. We propose that
this new version of OASIS be collected
on episodes of care with a
corresponding OASIS item (M0090) date
of January 1, 2010 or later. The OASIS–
C can be found using the following link:
https://www.cms.hhs.gov/Paperwork
ReductionActof1995/PRAL/
itemdetail.asp?filterType=none&filterBy
DID=-99&sortByDID=2&sortOrder=
descending&itemID=CMS1217682&
intNumPerPage=10
We are also planning to update Home
Health Compare to reflect the addition
of the following 13 new process of care
measures:
• Timely initiation of care,
• Influenza immunization received
for current flu season,
• Pneumococcal polysaccharide
vaccine ever received,
• Heart failure symptoms addressed
during short-term episodes,
• Diabetic foot care and patient
education implemented during shortterm episodes of care,
• Pain assessment conducted,
• Pain interventions implemented
during short-term episodes,
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• Depression assessment conducted,
• Drug education on all medications
provided to patient/caregiver during
short-term episodes.
• Falls risk assessment for patients 65
and older,
• Pressure ulcer prevention plans
implemented,
• Pressure ulcer risk assessment
conducted, and
• Pressure ulcer prevention included
in the plan of care.
Also under consideration are three
additional process of care measures that
may be added to Home Health Compare
based on results of consumer testing.
Those additional process measures are:
• Drug education on high risk
medications provided to patient/
caregiver at start of episode;
• Potential medication issues
identified and timely physician contact
at start of episode;
• Potential medication issues
identified and timely physician contact
during episode.
The implementation of OASIS–C will
impact the quality data reporting
requirement for the CY 2011 HH PPS.
However, we expect the conversion
from OASIS–B1 to OASIS–C to have
little to no impact on HHAs’ ability to
meet the quality data reporting
requirements under Section
1895(b)(3)(B)(v).
For CY 2011, CMS proposes to
expand the home health quality
measures reporting requirements to
include the Consumer Assessment of
Healthcare Providers and Systems
(CAHPS®) Home Health Care Survey
(pending OMB approval). The CAHPS®
Home Health Care Survey (hereafter
‘‘HHCAHPS’’) is a quality tool that we
believe that we can use to collect quality
of care data, as required by section
1895(b)(3)(B)(v)(II) of the Act, and as
permitted under section 1861(o)(8) of
the Act, which requires any Medicare
participating HHA to ‘‘meet [] such
additional requirements * * * as the
Secretary finds necessary for the
effective and efficient operation of the
program’’. The HHCAHPS data
collection will support the effective and
efficient operation of the program
because patients’ feedback on their
perspectives of the home health quality
of care from the agency cannot be
obtained from any other quality measure
in the program. The Home Health Care
Survey is part of a family of CAHPS®
surveys that ask patients to report on
and rate their experiences with health
care. The HHCAHPS survey developed
by the Agency for Healthcare Research
and Quality (AHRQ) which is part of the
Department of Health and Human
Services, presents home health patients
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with a set of standardized questions
about their home health care providers
and the quality of their home health
care. Prior to this survey, there was no
national standard for collecting
information about patient experiences
that would enable valid comparisons
across all HHAs.
AHRQ developed the HHCAHPS
survey with the assistance of many
entities (for example, government
agencies, professional stakeholders,
consumer groups and other key
individuals and organizations involved
in home health care). The HHCAHPS
survey was designed to measure and
assess the experiences of those persons
receiving home health care with the
following three goals in mind:
• To produce comparable data on
patients’ perspectives of care that allow
objective and meaningful comparisons
between home health agencies on
domains that are important to
consumers;
• To create incentives for agencies to
improve their quality of care through
public reporting of survey results; and
• To hold health care providers
accountable by informing the public
about the providers’ quality of care
(https://www.homehealthcahps.org).
These three goals support Section
1861(o)(8) of the Act, which requires
any Medicare participating HHA to
‘‘meet [] such additional requirements
* * * as the Secretary finds necessary
for the effective and efficient operation
of the program.’’
The development process for the
survey began in 2006 and included a
public call for measures, review of the
existing literature, consumer input,
stakeholder input, public response to
Federal Register notices, and a field test
conducted by AHRQ. AHRQ conducted
this field test to validate the length and
content of the HHCAHPS survey. CMS
submitted the survey to the National
Quality Forum (NQF) for consideration
and endorsement via their consensus
process. NQF endorsement represents
the consensus opinion of many
healthcare providers, consumer groups,
professional organizations, health care
purchasers, Federal agencies and
research and quality organizations. The
survey received NQF endorsement on
March 31, 2009.
The HHCAHPS survey includes 34
questions that cover topics such as
specific types of care provided by home
health providers, communication with
providers, interactions with the HHA,
and global ratings of the agency. For
public reporting purposes, CMS will
utilize composite measures and global
ratings of care. Each composite measure
consists of four or more questions that
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ask about one of the following related
topics:
• Patient care;
• Communications between providers
and patients;
• Specific care issues (medications,
home safety and pain).
There are also two global ratings; the
first rating asks the patient to assess the
care given by the HHA’s care providers,
and the second asks the patient about
his/her willingness to recommend the
HHA to family and friends.
We are proposing two options for
administering the HHCAHPS survey.
The agency can choose to administer the
existing HHCAHPS survey, or the HHA
can integrate additional questions
within the HHCAHPS survey. If an
agency chooses to implement an
integrated survey, the core questions
from the HHCAHPS survey (questions 1
through 25) must be placed before any
specific/supplemental questions that the
HHA wishes to add to the survey.
Questions 26 through 34 (the ‘‘About
You’’ survey questions) must be
administered as a unit—although they
may be placed either before or after any
supplemental questions that the HHA
wishes to add to the HHCAHPS survey.
If no HHA-specific questions are to be
added to the HHCAHPS survey, the
‘‘About You’’ questions should follow
the core questions (numbered 1 through
25) on the HHCAHPS survey.
The survey is currently available in
both English and Spanish. HHAs and
their survey vendors will not be
permitted to translate the HHCAHPS
survey into any other languages on their
own. However, CMS will provide
additional translations of the survey
over time. The Web site https://
www.homehealthcahps.org will provide
information about the subsequent
availability of additional translations.
CMS also solicits user suggestions for
any additional language translations.
Such suggestions should be submitted
online to the HHCAHPS Survey
Coordination Team, at
HHCAHPS@rti.org. HHAs interested in
learning about the survey are
encouraged to view the HHCAHPS
survey Web site, at https://
www.homehealthcahps.org. Agencies
can also call toll-free, 1–866–354–0985,
or send an e-mail to the HHCAHPS
Survey Coordination Team at
HHCAHPS@rti.org for more information.
The following types of home health
care patients will be considered eligible
to participate in the HHCAHPS survey:
• Current or discharged patients who
had at least one home health visit at any
time during the sample month;
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• Patients who were at least 18 years
of age at any time during the sample
period, and are believed to be alive;
• Patients who received at least two
visits from HHA personnel during a 60day look-back period (Note that the 60day look-back period is defined as the
60-day period prior to and including the
last day in the sample month.);
• Patients who have not been selected
for the monthly sample during any
month in the current quarter or during
the 5 months immediately prior to the
sample month;
• Patients who are not currently
receiving hospice care;
• Patients who do not have routine
‘‘maternity’’ care as the primary reason
for receiving home health care; and
• Patients who have not requested
‘‘no publicity status.’’
CMS has modeled HHCAHPS after the
Hospital CAHPS survey where both the
CAHPS and clinical data are collected
for both Medicare and non-Medicare
patients to get a complete picture of
hospital quality. Since HHCAHPS data
are not used to develop case-mix
collection of data for HHCAHPS are not
carried out under the auspices of section
4602(e) of the BBA, such collections are
not subject to the OASIS limitation to
Medicare and Medicaid patients only,
set out under section 704(a) of the
MMA. To collect and submit HHCAHPS
data to CMS, Medicare-certified
agencies will need to contract with an
approved HHCAHPS survey vendor.
Interested vendors can now apply to
become approved HHCAHPS vendors.
The application process is delineated
online at https://
www.homehealthcahps.org. Vendors
will also be required to attend training
conducted by CMS and the HHCAHPS
Survey Coordination Team. HHAs that
are interested in participating in the
HHCAHPS survey may do so on a
voluntary basis for the remaining
months of 2009. Such agencies must
select a vendor from the list of
HHCAHPS approved survey vendors.
This listing will be available on the Web
site https://www.homehealthcahps.org
during the summer of 2009.
CMS proposes that beginning in the
first quarter of CY 2010, all Medicarecertified HHAs shall begin to collect the
CAHPS® Home Health Care (HHCAHPS)
survey data in accordance with the
Protocols and Guidelines Manual
located on the HHCAHPS Web site
https://www.homehealthcahps.org.
HHAs shall contract with approved
HHCAHPS survey vendors that are
posted on https://
www.homehealthcahps.org to conduct
the survey on behalf of HHAs. CMS
proposes that participating home health
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agencies conduct a dry run of the survey
for at least one month in the first quarter
of 2010 (January, and/or February, and/
or March 2010), and submit the dry run
data to the Home Health CAHPS® Data
Center by 11:59 p.m. EST on June 23,
2010. The dry run data would not be
publicly reported on the Home Health
Compare. This dry run would provide
an opportunity for vendors and HHAs to
acquire first-hand experience with data
collection, including sampling and data
submission to the Home Health
CAHPS® Data Center, with no public
reporting of the results. CMS proposes
that all Medicare-certified HHAs
continuously collect HHCAHPS survey
data every quarter beginning in the
second quarter (April, May and June) of
2010, and submit these data for the
second quarter of 2010 to the Home
Health CAHPS® Data Center by 11:59
p.m. EST on September 22, 2010. CMS
proposes that these data submission
deadlines are firm; that is, there will be
no late submissions allowed.
The Medicare-certified HHAs will
need to provide their respective survey
vendors with information about their
survey-eligible patients (either current
or discharged) every month in
accordance with the Protocols and
Guidelines Manual posted on https://
www.homehealthcahps.org. The details
about selecting the HHA sample are
delineated in the Protocols and
Guidelines manual on the Web site
https://www.homehealthcahps.org. It is
proposed that the HHCAHPS survey
data be submitted and analyzed
quarterly, and that the sample selection
and data collection occur on a monthly
basis. HHAs should target 300
HHCAHPS survey completes annually.
Smaller agencies that are unable to
reach 300 survey completes by sampling
should survey all HHCAHPS eligible
patients. For reasons of statistical
precision, a target minimum of 300 or
more completed Home Health CAHPS
surveys has been set for each home
health agency. 300 completes is based
on a reliability target of 0.8 or higher.
We propose that survey vendors initiate
the survey for each monthly sample
within three weeks after the end of the
sample month. All data collection for
each monthly sample would have to be
completed within six weeks (42 days)
after data collection began. CMS has
approved three modes of the survey to
be used: Mail only, telephone only, and
mail with telephone follow-up (the
‘‘mixed mode’’). We are proposing that
for mail-only and mixed-mode surveys,
data collection for a monthly sample
would have to end six weeks after the
first questionnaire was mailed. For
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telephone-only surveys, data collection
would have to end six weeks following
the first telephone attempt.
CMS is aware that there is a wide
variation in the size of Medicarecertified HHAs. CMS proposes that the
requirement to collect HHCAHPS
survey data be waived for agencies that
serve fewer than 60 HHCAHPS eligible
patients annually. We are proposing this
threshold amount in order to exempt
agencies that serve a very small home
health eligible population. These
agencies serve, on average, 5 or fewer
patients per month. The HHCAHPS
eligible, unduplicated patient counts for
the period of October 1 through
September 30 for a given year would be
used to determine if the HHA would
have to participate in the HHCAHPS
survey in the next calendar year. If a
Medicare-certified HHA had fewer than
60 eligible, unduplicated HHCAHPS
eligible patients for the period October
1 through September 30, then they
would be excluded from the HHCAHPS
requirement for the next calendar year.
For example, if a small HHA had 85
patients in the period October 1, 2008
through September 30, 2009, and 45 of
the patients were routine maternity
patients, then there would only be 40
HHCAHPS eligible patients. This agency
would therefore not be required to
participate in the HHCAHPS survey.
Alternatively, if a small HHA had 85
patients for the period October 1, 2008
through September 30, 2009, and 70 of
these patients were eligible to
participate in the HHCAHPS survey
(i.e., because they: (1) Were 65 years or
older; (2) were recently discharged from
the hospital to their homes; (3) were not
receiving hospice care; (4) were not
designated as ‘‘no publicity’’ patients;
and (5) had received at least two home
health visits) this agency would be
required to participate in the HHCAHPS
survey. Only Medicare-certified HHAs
with fewer than 60 eligible,
unduplicated patients for the period
October 1, 2008 through September 30,
2009 would submit their patient counts
to the HHCAHPS Data Center by
Wednesday, January 13, 2010.
We also propose that newly Medicarecertified HHAs (that is, those certified
on or after January 1, 2010 for payments
to be made in CY 2011) be excluded
from the HHCAHPS survey reporting
requirement, as data submission and
analysis would not be possible for an
agency so late in the reporting period.
In future years, agencies that first certify
on or after January 1 of the preceding
year would be excluded from any
payment penalty for reporting purposes
in the following CY. We note that this
exclusion for new HHAs pertains only
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to the HHCAHPS survey reporting
requirement.
CMS strongly recommends that HHAs
participating in HHCAHPS survey
promptly review the required Data
Submission Summary Reports that are
delineated in the Protocols and
Guidelines Manual posted on https://
www.homehealthcahps.org. These
reports will enable the HHA to ensure
that its survey vendor has submitted
their data on time, and that the data has
been accepted/received by the Home
Health CAHPS® Data Center.
CMS anticipates first reporting
HHCAHPS survey data in early 2011 on
Home Health Compare. The HHCAHPS
survey data would be updated quarterly.
HHAs would be provided a preview of
the data each quarter before it was
reported on Home Health Compare.
CMS proposes that vendors and HHAs
be required to participate in HHCAHPS
survey oversight activities to ensure
compliance with HHCAHPS survey
protocols, guidelines and survey
requirements. The purpose of the
oversight activities is to ensure that
HHAs and approved survey vendors
follow the Protocols and Guidelines
Manual. It is proposed that all approved
survey vendors develop a Quality
Assurance Plan (QAP) for survey
administration in accordance with the
Protocols and Guidelines Manual. The
QAP should include the following:
• Organizational chart;
• Work plan for survey
implementation;
• Description of survey procedures
and quality controls;
• Quality assurance oversight of onsite work and of all subcontractors
work; and
• Confidentiality/Privacy and
Security procedures in accordance with
the Health Insurance Portability and
Accountability Act (HIPAA).
As part of the oversight activities the
HHCAHPS Survey Coordination Team
would conduct on-site visits or
conference calls. The HHCAHPS Survey
Coordination Team would review the
survey vendor’s survey systems, and
will assess administration protocols
based on the Protocols and Guidelines
Manual posted on https://
www.homehealthcahps.org. All
materials relevant to survey
administration would be subject to
review. The proposed systems and
program review would include, but not
be limited to: (a) Survey management
and data systems; (b) printing and
mailing materials and facilities; (c) data
receipt, entry and storage facilities; and
(d) written documentation of survey
processes. Organizations would be given
a defined time period in which to
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correct any problems and provide
follow-up documentation of corrections
for review. Survey vendors will be
subject to follow-up site visits as
needed.
CMS strongly recommends that all
HHAs participating in the HHCAHPS
survey regularly check the Web site,
https://www.homehealthcahps.org for
program updates and information.
As mandated in current law, all
HHAs, unless covered by specific
exclusions, will continue to be required
to meet the quality reporting
requirements or be subject to a 2 percent
reduction in the home health market
basket percentage increase in
accordance with section
1895(b)(3)(B)(v)(I) of the Act. A
reconsideration and appeals process is
being developed for HHAs who fail to
meet the HHCAHPS reporting
requirements. These procedures would
be outlined in the HH PPS proposed
rule for CY 2011 in which we are
proposing that the HHCAHPS survey
would be linked to home health
payment, as a requirement under the
regulation requiring the reporting of
quality data.
3. Home Health Wage Index
Sections 1895(b)(4)(A)(ii) and (b)(4)(C)
of the Act require the Secretary to
establish area wage adjustment factors
that reflect the relative level of wages
and wage-related costs applicable to the
furnishing of home health services and
to provide appropriate adjustments to
the episode payment amounts under the
HH PPS to account for area wage
differences. As discussed previously, we
apply the appropriate wage index value
to the labor portion (77.082 percent) of
the HH PPS rates based on the site of
service for the beneficiary (defined by
section 1861(m) of the Act as the
beneficiary’s place of residence).
Generally, we determine each HHA’s
labor market area based on definitions
of Metropolitan Statistical Areas (MSAs)
issued by the Office of Management and
Budget (OMB). We have consistently
used the pre-floor, pre-reclassified
hospital wage index data to adjust the
labor portion of the HH PPS rates. We
believe the use of the pre-floor, prereclassified hospital wage index data
results in the appropriate adjustment to
the labor portion of the costs as required
by statute.
In the November 9, 2005 final rule for
CY 2006 (70 FR 68132), we adopted
revised labor market area definitions
based on Core-Based Statistical Areas
(CBSAs). At the time, we noted that
these were the same labor market area
definitions (based on OMB’s new CBSA
designations) implemented under the
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Hospital Inpatient Prospective Payment
System (IPPS). In adopting the CBSA
designations, we identified some
geographic areas where there are no
hospitals and, thus, no hospital wage
data on which to base the calculation of
the home health wage index. We
continue to use the methodology
discussed in the November 9, 2006 final
rule for CY 2007 (71 FR 65884) to
address the geographic areas that lack
hospital wage data on which to base the
calculation of their home health wage
index. For rural areas that do not have
IPPS hospitals, we use the average wage
index from all contiguous CBSAs as a
reasonable proxy. This methodology is
used to calculate the wage index for
rural Massachusetts. However, we could
not apply this methodology to rural
Puerto Rico due to the distinct
economic circumstances that exist there,
but instead continue using the most
recent wage index previously available
for that area (from CY 2005). For urban
areas without IPPS hospitals, we use the
average wage index of all urban areas
within the State as a reasonable proxy
for the wage index for that CBSA. The
only urban area without IPPS hospital
wage data is Hinesville-Fort Stewart,
Georgia (CBSA 25980).
On November 20, 2008, OMB issued
Bulletin No. 09–01 located at Web
address https://www.whitehouse.gov/
omb/bulletins/fy2009/09–01.pdf. This
bulletin highlights three geographic
areas that were previously classified as
Micropolitan Statistical Areas but now
qualify as Metropolitan Statistical
Areas. The three areas are (1) CBSA
16020, Cape Girardeau-Jackson, MO–IL
(this includes Alexander County in
Illinois and Bollinger and Cape
Girardeau Counties in Missouri); (2)
CBSA 31740, Manhattan, KS (this
includes Geary, Pottawatomie, and Riley
Counties in Kansas); and (3) CBSA
31860, Mankato-North Mankato, MN
(this includes Blue Earth and Nicollet
Counties in Minnesota). These three
new CBSAs and their associated wage
index values are shown in Addendum
B.
4. Proposed CY 2010 Payment Update
a. National Standardized 60-Day
Episode Rate
The Medicare HH PPS has been in
effect since October 1, 2000. As set forth
in the final rule published July 3, 2000
in the Federal Register (65 FR 41128),
the unit of payment under the Medicare
HH PPS is a national standardized 60day episode rate. As set forth in
§ 484.220, we adjust the national
standardized 60-day episode rate by a
case-mix relative weight and a wage
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jlentini on DSKJ8SOYB1PROD with PROPOSALS2
index value based on the site of service
for the beneficiary.
In the CY 2008 HH PPS final rule with
comment period, we refined the casemix methodology and also rebased and
revised the home health market basket.
The labor-related share of the case-mix
adjusted 60-day episode rate is 77.082
percent and the non-labor-related share
is 22.918 percent. The proposed CY
2010 HH PPS rates use the same casemix methodology and application of the
wage index adjustment to the labor
portion of the HH PPS rates as set forth
in the CY 2008 HH PPS final rule with
comment period. We multiply the
national 60-day episode rate by the
patient’s applicable case-mix weight.
We divide the case-mix adjusted
amount into a labor and non-labor
portion. We multiply the labor portion
by the applicable wage index based on
the site of service of the beneficiary. We
add the wage-adjusted portion to the
non-labor portion yielding the case-mix
and wage adjusted 60-day episode rate
subject to any additional applicable
adjustments.
In accordance with section
1895(b)(3)(B) of the Act, we update the
HH PPS rates annually in a separate
Federal Register document. The HH
PPS regulations at 42 CFR 484.225 set
forth the specific annual percentage
update. In accordance with § 484.225(i),
in the case of a HHA that does not
submit home health quality data, as
specified by the Secretary, the
unadjusted national prospective 60-day
episode rate is equal to the rate for the
previous calendar year increased by the
applicable home health market basket
index amount minus two percentage
points. Any reduction of the percentage
change will apply only to the calendar
year involved and will not be taken into
account in computing the prospective
payment amount for a subsequent
calendar year.
For CY 2010, we will base the wage
index adjustment to the labor portion of
the HH PPS rates on the most recent
pre-floor and pre-reclassified hospital
wage index. As discussed in the July 3,
2000 HH PPS final rule, for episodes
with four or fewer visits, Medicare pays
the national per-visit amount by
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discipline, referred to as a LUPA. We
update the national per-visit rates by
discipline annually by the applicable
home health market basket percentage.
We adjust the national per-visit rate by
the appropriate wage index based on the
site of service for the beneficiary, as set
forth in § 484.230. We will adjust the
labor portion of the updated national
per-visit rates used to calculate LUPAs
by the most recent pre-floor and prereclassified hospital wage index, as
discussed in the CY 2008 HH PPS final
rule with comment period. We are also
updating the LUPA add-on payment
amount and the NRS conversion factor
by the applicable home health market
basket update of 2.2 percent for CY
2010.
Medicare pays the 60-day case-mix
and wage-adjusted episode payment on
a split percentage payment approach.
The split percentage payment approach
includes an initial percentage payment
and a final percentage payment as set
forth in § 484.205(b)(1) and
§ 484.205(b)(2). We may base the initial
percentage payment on the submission
of a request for anticipated payment
(RAP) and the final percentage payment
on the submission of the claim for the
episode, as discussed in § 409.43. The
claim for the episode that the HHA
submits for the final percentage
payment determines the total payment
amount for the episode and whether we
make an applicable adjustment to the
60-day case-mix and wage-adjusted
episode payment. The end date of the
60-day episode as reported on the claim
determines which calendar year rates
Medicare would use to pay the claim.
We may also adjust the 60-day casemix and wage-adjusted episode
payment based on the information
submitted on the claim to reflect the
following:
• A low utilization payment provided
on a per-visit basis as set forth in
§ 484.205(c) and § 484.230.
• A partial episode payment
adjustment as set forth in § 484.205(d)
and § 484.235.
• An outlier payment as set forth in
§ 484.205(e) and § 484.240.
b. Proposed Updated CY 2010
National Standardized 60-Day Episode
Payment Rate
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In calculating the annual update for
the CY 2010 national standardized 60day episode payment rates, we first look
at the CY 2009 rates as a starting point.
The CY 2009 national standardized 60day episode payment rate is $2,271.92.
As previously discussed in section
II.B., ‘‘Outlier Policy’’, of this proposed
rule, in our proposed policy of targeting
outlier payments to be approximately
2.5 percent of total HH PPS payments in
CY 2010, we are proposing to return 2.5
percent back into the HH PPS rates, to
include the national standardized 60day episode payment rate. As such, to
calculate the proposed CY 2010 national
standardized 60-day episode payment
rate, we first increase the CY 2009
national standardized 60-day episode
payment rate ($2,271.92) to adjust for
the 5 percent originally set aside for
outlier payments. We then reduce that
adjusted payment amount by 2.5
percent, the proposed target percentage
of outlier payments as a percentage of
total HH PPS payment. Next, we update
by the current proposed CY 2010 home
health market basket update percentage
of 2.2 percent.
As previously discussed in Section
II.C., ‘‘Case-Mix Measurement
Analysis’’, of this proposed rule, our
updated analysis of the change in casemix not due to an underlying change in
patient health status reveals additional
increase in nominal change in case-mix.
However, we are maintaining our
existing policy to reduce rates by 2.75
percent in CY 2010. Consequently, to
calculate the proposed CY 2010 national
standardized 60-day episode payment
rate, we then reduce the rate by 2.75
percent, for a proposed updated CY
2010 national standardized 60-day
episode payment rate of $2,325.79. The
proposed updated CY 2010 national
standardized 60-day episode payment
rate for an HHA that submits the
required quality data is shown in Table
2. The proposed updated CY 2010
national standardized 60-day episode
payment rate for an HHA that does not
submit the required quality data (home
health market basket update of 2.2
percent is reduced by 2 percent) is
shown in Table 3.
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TABLE 2—PROPOSED NATIONAL STANDARDIZED 60-DAY EPISODE PAYMENT RATE UPDATED BY THE PROPOSED HOME
HEALTH MARKET BASKET UPDATE FOR CY 2010, BEFORE CASE-MIX ADJUSTMENT AND WAGE ADJUSTMENT BASED
ON THE SITE OF SERVICE FOR THE BENEFICIARY
CY 2009 National
Standardized 60-Day
Episode Payment
Rate
Adjusted to return the
outlier funds, that
paid for the original
5% target for outlier
payments
Adjusted to account
for the proposed 2.5%
outlier policy
Multiply by the proposed home health
market basket update
(2.2 percent) 1
Reduce by 2.75
percent for nominal
change in case-mix
Proposed CY 2010
National Standardized
60-Day Episode
Payment Rate
$2,271.92
/ 0.95
× 0.975
× 1.022
× 0.9725
$2,317.47
1 The
proposed estimated home health market basket update of 2.2 percent for CY 2010 is based on Global Insight Inc., 1st Qtr 2009 forecast
with historical data through 4th Qtr 2008.
TABLE 3—FOR HHAS THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA; PROPOSED NATIONAL STANDARDIZED 60DAY EPISODE PAYMENT RATE UPDATED BY THE PROPOSED HOME HEALTH MARKET BASKET UPDATE FOR CY 2010,
BEFORE CASE-MIX ADJUSTMENT AND WAGE ADJUSTMENT BASED ON THE SITE OF SERVICE FOR THE BENEFICIARY
Total CY 2009
National Standardized
60-Day Episode
Payment Rate
Adjusted to return the
outlier funds, that
paid for the original
5% target for outliers
Adjusted to account
for the proposed 2.5%
outlier policy
Multiply by the proposed home health
market basket update
(2.2 percent) 1 minus
2 percent for a 0.2
percent update
Reduce by 2.75
percent for nominal
change in case-mix
Proposed CY 2010
National Standardized
60-Day Episode Payment Rate for HHAs
that do not submit
required quality data
$2,271.92
/ 0.95
× 0.975
× 1.002
× 0.9725
$2,272.12
1 The
proposed estimated home health market basket update of 2.2 percent for CY 2010 is based on Global Insight Inc., 1st Qtr 2009 forecast
with historical data through 4th Qtr 2008.
c. Proposed National Per-Visit Rates
Used To Pay LUPAs and Compute
Imputed Costs Used in Outlier
Calculations
In calculating the proposed CY 2010
national per-visit rates used to calculate
payments for LUPA episodes and to
compute the imputed costs in outlier
calculations, we start with the CY 2009
national per-visit rates. We first adjust
the CY 2009 national per-visit rates to
adjust for the 5 percent originally set
aside for outlier payments. We then
reduce those national per-visit rates by
2.5 percent, the proposed target
percentage of outlier payments as a
percentage of total HH PPS payment.
Next we update by the current proposed
CY 2010 home health market basket
update percentage of 2.2 percent.
National per-visit rates are not subject to
the 2.75 percent reduction related to the
nominal increase in case-mix because
they are per-visit rates and hence not
case-mix adjusted. The proposed CY
2010 national per-visit rates per
discipline are shown in Table 4. The six
home health disciplines are Home
Health Aide (HH aide), Medical Social
Services (MSS), Occupational Therapy
(OT), Physical Therapy (PT), Skilled
Nursing (SN), and Speech Language
Therapy (SLP).
TABLE 4—PROPOSED NATIONAL PER-VISIT RATES FOR LUPAS (NOT INCLUDING THE LUPA ADD-ON PAYMENT AMOUNT
FOR A BENEFICIARY’S ONLY EPISODE OR THE INITIAL EPISODE IN A SEQUENCE OF ADJACENT EPISODES) AND
OUTLIER CALCULATIONS UPDATED BY THE PROPOSED CY 2010 HOME HEALTH MARKET BASKET UPDATE, BEFORE
WAGE INDEX ADJUSTMENT
For HHAs that DO submit
the required quality data
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
Home Health Discipline Type
CY 2009
Per-Visit
Amounts
Per 60-Day
Episode for
LUPAs
Home Health Aide .....................................................................
Medical Social Services ............................................................
Occupational Therapy ...............................................................
Physical Therapy .......................................................................
Skilled Nursing ..........................................................................
Speech-Language Pathology ....................................................
$48.89
173.05
118.83
118.04
107.95
128.26
Adjusted to
return the
outlier funds
that paid for
the original
5% target
for outlier
payments
/
/
/
/
/
/
0.95
0.95
0.95
0.95
0.95
0.95
Adjusted to
account for
the
proposed
2.5% outlier
policy
×
×
×
×
×
×
0.975
0.975
0.975
0.975
0.975
0.975
Multiply by
the
proposed
home health
market
basket
update
(2.2 percent) 1
×
×
×
×
×
×
1.022
1.022
1.022
1.022
1.022
1.022
CY 2010
per-visit
payment
amount for
HHAs that
DO submit
the required
quality data
$51.28
181.51
124.64
123.81
113.23
134.53
For HHAs that DO NOT
submit the required
quality data
Multiply by
the proposed home
health market basket
update (2.2
percent) 1
minus 2
percent, for
a 0.2 percent update
×
×
×
×
×
×
1.002
1.002
1.002
1.002
1.002
1.002
CY 2010
per-visit
payment
amount for
HHAs that
DO NOT
submit the
required
quality data
$50.28
177.96
122.20
121.39
111.01
131.90
1 The proposed estimated home health market basket update of 2.2 percent for CY 2010 is based on Global Insight Inc., 1st Qtr 2009 forecast with historical data
through 4th Qtr 2008.
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d. Proposed LUPA Add-On Payment
Amount Update
Beginning in CY 2008, LUPA episodes
that occur as the only episode or initial
episode in a sequence of adjacent
episodes are adjusted by adding an
additional amount to the LUPA
payment before adjusting for area wage
differences. As previously discussed, we
are proposing to return 2.5 percent back
into the HH PPS rates, to include the
LUPA add-on payment amount, as a
result of our proposed policy to target
outlier payments to be approximately
2.5 percent of total HH PPS payments in
CY 2010. As such, we first adjust the CY
2009 LUPA add-on payment amount to
adjust for the 5 percent originally set
aside for outlier payments. We then
reduce that amount by 2.5 percent, the
proposed target percentage of outlier
payments as a percentage of total HH
PPS payment. Next we update by the
current proposed CY 2010 home health
market basket update percentage of 2.2
percent. The LUPA add-on payment
amount is not subject to the 2.75 percent
reduction related to the nominal
increase in case-mix because it is an
add-on to the per-visit rates which are
not case-mix adjusted. The proposed CY
2010 LUPA add-on payment amount is
shown in Table 5 below. Just as the
standardized 60-day episode rate and
the per-visit rates paid to HHAs that do
not submit the required quality are
reduced by 2 percent, the additional
LUPA payment should be reduced by 2
percent also. In neither the CY 2008 nor
the CY 2009 HH PPS rulemaking did we
include such an adjustment to the LUPA
add-on payment amount. For CY 2010,
we propose that the add-on to the LUPA
payment to HHAs that submit the
required quality data would be updated
by the home health market basket
update. We propose that the add-on to
the LUPA payment to HHAs that do not
submit the required quality data would
be updated by the home health market
basket update minus two percent.
TABLE 5—PROPOSED CY 2010 LUPA ADD-ON PAYMENT AMOUNTS
For HHAs that DO submit the required
quality data
CY 2009 LUPA
add-on payment
amount
adjusted to return
the outlier funds,
that paid for the
original 5% target
for outliers
Adjusted to return
the outlier funds,
that paid for the
original 5% target
for outliers
Adjusted to account for the proposed 2.5% outlier
policy
$90.48
/ 0.95
× 0.975
For HHAs that DO NOT submit the required quality data
Multiply by the
proposed home
health market basket update (2.2
percent)1
Proposed CY
2010 LUPA addon payment
amount for HHAs
that DO submit required quality data
Multiply by the
proposed home
health market basket update (2.2
percent) 1 minus 2
percent, for a 0.2
percent update
Proposed CY
2010 LUPA addon payment
amount for HHAs
that DO NOT submit required quality data
× 1.022
$94.90
× 1.002
$93.05
1 The
proposed estimated home health market basket update of 2.2 percent for CY 2010 is based on Global Insight Inc., 1st Qtr 2009 forecast
with historical data through 4th Qtr 2008.
e. Proposed Non-Routine Medical
Supply Conversion Factor Update
Payments for non-routine medical
supplies (NRS) are computed by
multiplying the relative weight for a
particular severity level by the NRS
conversion factor. We first adjust the CY
2009 NRS conversion factor ($52.39) to
adjust for the 5 percent originally set
aside for outlier payments. We then
reduce that amount by 2.5 percent, the
proposed target percentage of outlier
payments as a percentage of total HH
PPS payment. Next we update by the
current proposed CY 2010 home health
market basket update percentage of 2.2
percent. Finally, we then reduce that
adjusted payment amount by 2.75, to
account for the increase in nominal
case-mix. The proposed CY 2010 NRS
conversion factor is shown in Table 6a
below. The NRS conversion factor for
CY 2009 was $52.39. Consequently, for
CY 2010, the proposed NRS conversion
factor would be $53.44.
TABLE 6a—PROPOSED CY 2010 NRS CONVERSION FACTOR FOR HHAS THAT DO SUBMIT THE REQUIRED QUALITY DATA
CY2009 NRS
Conversion Factor
Adjusted to return the
outlier funds, that
paid for the original
5% target for outlier
payments
Adjusted to account
for the proposed 2.5%
outlier policy
Multiply by the proposed home health
market basket update
(2.2 percent)
Reduce by
2.75 percent for nominal change in casemix
Proposed CY 2010
NRS Conversion Factor for HHAs that Do
submit the required
quality data
$52.39
/ 0.95
× 0.975
× 1.022
× 0.9725
$53.44
The proposed payment amounts,
using the above computed proposed CY
2010 NRS conversion factor ($53.44), for
the various severity levels based on the
proposed updated conversion factor are
calculated in Table 6b.
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
TABLE 6b—RELATIVE WEIGHTS FOR THE 6-SEVERITY NRS SYSTEM
Severity level
1
2
3
4
5
6
................................................................................
................................................................................
................................................................................
................................................................................
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0.2698
0.9742
2.6712
3.9686
6.1198
10.5254
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NRS payment
amount
$14.42
52.06
142.75
212.08
327.04
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For HHAs that do not submit the
required quality data, we again begin
with the CY 2009 NRs conversion factor.
We first adjust the CY 2009 NRS
conversion factor ($52.39) to adjust for
the 5 percent originally set aside for
outlier payments. We then reduce that
amount by 2.5 percent, the proposed
target percentage of outlier payments as
a percentage of total HH PPS payment.
Next we update by the current proposed
CY 2010 home health market basket
update percentage of 2.2 percent minus
2 percent for a 0.002 percent update.
Finally, we then reduce that adjusted
payment amount by 2.75, to account for
the increase in nominal case-mix. The
proposed CY 2010 NRS conversion
factor is shown in Table 7a below.5
TABLE 7a—PROPOSED CY 2010 NRS CONVERSION FACTOR FOR HHAS THAT DO NOT SUBMIT THE REQUIRED QUALITY
DATA
CY 2009 NRS Conversion
Factor
Adjusted to return the outlier
funds, that paid for the original 5% target for outlier payments
Adjusted to account for the proposed 2.5% outlier
policy
Multiply by the
proposed home
health market basket update (2.2
percent) minus 2
percent for a 0.25
update
Reduce by
2.75 percent for
nominal change in
case-mix
Proposed CY
2010 NRS Conversion Factor for
HHAs that Do
submit the
required quality
data
$52.39 ...................................
/ 0.95 .....................................
× 0.975
× 1.002
× 0.9725
$52.39
The proposed payment amounts for
the various severity levels based on the
proposed updated conversions factor,
for HHAs that do not submit quality
data, are calculated in Table 7b, below.
TABLE 7b—RELATIVE WEIGHTS FOR THE 6-SEVERITY FOR HHAS THAT DO NOT SUBMIT QUALITY DATA
Severity level
1
2
3
4
5
6
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
D. OASIS Issues
1. HIPPS Code Reporting
We would first like to clarify our
policy regarding the submission of the
Health Insurance Prospective Payment
System (HIPPS) code to CMS via the
OASIS. § 484.250 requires HHAs to
submit to CMS the OASIS data
described in § 484.55(b)(1) and
§ 484.55(d)(1) in order for CMS to
administer the payment rate
methodologies. Also, as described in
§ 484.20, HHAs must electronically
report all OASIS data collected in
accordance with § 484.55 as a condition
of participation, and HHAs must encode
and electronically transmit the
completed OASIS assessment to CMS in
the standard data format as described in
§ 484.20(d). For those OASIS
assessments required for payment, the
standard format which is electronically
transmitted by the HHA to CMS
includes a HIPPS code, generated by
grouper software at the HHA. When an
HHA electronically transmits OASIS
assessments to CMS (via the State
agency), the CMS OASIS submission
system performs a validation check of
the transmitted OASIS items, including
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the submitted HIPPS code. If the CMS
OASIS submission system validation
determines that the submitted HIPPS
code is in error, it informs HHAs of that
error via the Final Validation Report
which is returned to HHA. The Final
Validation Report will include the valid,
CMS OASIS submission system
calculated HIPPS code. We have become
aware of a proliferation of incidents
where the HIPPS code submitted to
CMS on the OASIS does not match the
HIPPS code which is calculated by the
CMS OASIS submission system. The
HH PPS Grouper Software, which is
used by the CMS OASIS submission
system in its validation, is the official
grouping software of the HH PPS, and
thus the HIPPS code produced by the
CMS OASIS submission system is the
HIPPS code that should ultimately be
billed on the claim. Consequently, in
the interest of accurate coding and
billing, we propose that the HHA be
required to ensure that the HIPPS code
billed on the claim is consistent with
that which CMS’ OASIS submission
system calculated. In the case where the
Final Validation Report returns to the
HHA a HIPPS code which is different
than the HIPPS code submitted to CMS
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0.9742
2.6712
3.9686
6.1198
10.5254
Proposed NRS
payment
amount
$14.13
51.04
139.94
207.91
320.62
551.43
by the HHA on the OASIS, the HHA
must ensure that the HIPPS code from
the Final Validation report is the HIPPS
code reported on the bill.
2. OASIS Submission as a ‘‘Condition of
Payment’’
Section 484.20 requires that HHAs
must electronically report to CMS (via
the State agency or OASIS contractor)
all OASIS data collected in accordance
with § 484.55 as a condition of
participation. Additionally, § 484.250
requires that HHAs must submit to CMS
the OASIS data described at
§ 484.55(b)(1) and (d)(1) in order for
CMS to administer the payment rate
methodologies. Building on the above
clarification for HHAs to ensure the
HIPPS code reported on the bill is
consistent with that which CMS’ OASIS
submission system calculated, and in
order to be consistent with § 484.250,
we are proposing to require the
electronic reporting of OASIS to CMS as
a condition of payment in § 484.210.
Currently, as a requirement for pay for
reporting, HHAs are required to submit
quality data (that being OASIS data) in
order to receive the full home health
market basket update to the rates. The
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burden associated with the requirement
for the HHA to submit the OASIS is
currently accounted for under OMB#
0938–0761. Making OASIS submission a
condition for payment is consistent with
both OASIS submissions being a
condition of participation and a
requirement to receive full market
basket updates under pay for reporting.
As such, we are proposing to revise
§ 484.210 ‘‘Data used for the calculation
of the national prospective 60-day
episode payment’’ to reflect this
requirement.
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
E. Qualifications for Coverage as They
Relate to Skilled Services Requirements
To qualify for Medicare coverage of
home health services a Medicare
beneficiary must meet each of the
following requirements as stipulated in
§ 409.42: Be confined to the home or an
institution that is not a hospital, SNF, or
nursing facility as defined in sections
1861(e)(1), 1819(a)(1) or 1919 of Act; be
under the care of a physician as
described in § 409.42(b); be under a plan
of care that meets the requirements
specified in § 409.43; the care must be
furnished by or under arrangements
made by a participating HHA, and the
beneficiary must be in need of skilled
services as described in § 409.42(c).
Subsection 409.42(c) of our regulations
requires that the beneficiary need at
least one of the following services as
certified by a physician in accordance
with § 424.22: Intermittent skilled
nursing services and the need for skilled
services which meet the criteria in
§ 409.32; Physical therapy which meets
the requirements of § 409.44(c), Speechlanguage pathology which meets the
requirements of § 409.44(c); or have a
continuing need for occupational
therapy that meets the requirements of
§ 409.44(c), subject to the limitations
described in § 409.42(c)(4).
Basis for Revisions to § 409.42(c)(1),
409.44(b), and § 424.22
In recent years, MedPAC, the HHS
Office of the Inspector General (OIG),
and Medicaid State agencies suggested
the need for CMS to clarify the Medicare
home health coverage criteria regarding
the skilled services specified at § 409.42.
In their March 2004 report (https://
www.medpac.gov/documents/
Mar04_Entire_reportv3.pdf), MedPAC
reported that the Medicare eligibility
criteria for the home health benefits
leaves a great deal open to
interpretation, describing a particular
concern with the lack of clarity
regarding the Medicare home health
skilled nursing services requirement. In
their Memorandum Report dated
February 5, 2009 titled ‘‘Medicaid and
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Medicare Home Health Payments for
Skilled Nursing and Home Health Aide
Services’’ (https://oig.hhs.gov/oei/
reports/oei-07–06–00641.pdf), the OIG
also stated that Medicare coverage
policy regarding skilled nursing services
lacked clarity. The OIG indicated that
our payment methodology might be
prone to error. HHAs were unclear
about which skilled nursing services
were covered by Medicare’s home
health benefit. Further, Medicaid State
agencies have also communicated to
CMS their concerns that HHAs find it
difficult to accurately determine when
services provided to dually Medicare
and Medicaid eligible individuals
(‘‘dual eligibles’’) meet the Medicare
coverage criteria, especially the
requirements for needing skilled
nursing care on an intermittent basis.
State Medicaid agencies have
communicated to CMS that this
ambiguity is resulting in some HHAs
routinely submitting all claims for dualeligible persons with chronic care needs
to their State Medicaid agencies for
payment. State Medicaid agencies and
CMS are concerned about this practice,
referencing the requirement under the
Social Security Act that Medicaid must
be the payer of last resort. State agencies
have told CMS that some of these claims
would have been covered and paid by
Medicare if they were submitted for
payment. Other State agencies have
used Medicaid post payment reviews to
identify claims they believe should have
been paid by another payer (e.g.,
Medicare).
In 2006, CMS and certain Medicaid
State Agencies embarked on an
educational initiative to improve the
ability of HHAs, State Agencies, and
CMS contractors to make appropriate
coverage decisions, resulting in an
improved ability by HHAs to identify
the appropriate payer for services
provided, ultimately improving HHA
billing accuracy.
As part of its provider education
program, CMS focused on clarifying
§ 409.42 ‘‘Beneficiary qualifications for
coverage of services’’. During the course
of the training, it became apparent that
confusion existed among certain
Medicaid State Agencies and HHAs
regarding under what circumstances the
overall management and evaluation of a
care plan would constitute a skilled
service. HHAs asked what underlying
conditions, complications, or
circumstances would require a patient
otherwise receiving unskilled services
to need care plan management and
evaluation by a registered nurse, thus
rendering such care skilled. CMS
therefore ensured that the training
provided a particular focus on the
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requirement that a beneficiary be in
need of skilled services. CMS provided
comprehensive guidance to clarify that
in the home health setting, management
and evaluation of a patient care plan is
considered a reasonable and necessary
skilled service only when underlying
conditions or complications are such
that only a registered nurse can ensure
that essential non-skilled care is
achieving its purpose. Another area of
confusion that surfaced during the
training was when the need for patient
education services constitutes skilled
services in the home health setting.
HHAs questioned which specific sorts
of educational services would render
the education a skilled service in the
home health setting.
To address the concerns identified by
OIG, MedPAC, State Medicaid agencies
and the clarity concerns home health
agencies communicated to CMS during
the 2006 training, we propose to revise
§ 409.42(c)(1) to further clarify that in
order for services to be considered
skilled in the home health setting,
certain limitations (discussed below)
would apply. We believe these revisions
would assist HHAs in their
determination of home health eligibility
and will enable HHAs to more
accurately bill for their dual eligible
population.
Proposed Revisions to § 409.42(c)(1)
To clarify what constitutes skilled
services in the home health setting, we
are proposing the following revision to
§ 409.42. We propose to add a qualifying
instruction to § 409.42(c)(1) to explain
that intermittent skilled nursing services
meeting the criteria for skilled services
and the need for skilled services found
in § 409.32 (with examples in § 409.33
(a) and (b)) are subject to certain
limitations in the home health setting.
We propose to describe the limitations
in two new paragraphs, § 409.42(c)(1)(i)
and § 409.42(c)(1)(ii).
Proposed New Paragraph
§ 409.42(c)(1)(i)
Our policy at § 409.33(a)(1) describes
that the development, management, and
evaluation of a patient’s care plan based
on physician’s orders constitute skilled
services when, because of the patient’s
physical or medical condition, oversight
by technical or professional personnel is
needed to promote recovery and ensure
medical safety. The examples described
in § 409.33(a)(1)(ii) further describe that
when the patient’s overall condition
supports a finding that recovery and
safety can be ensured only if the total
care is planned, managed, and evaluated
by technical or professional personnel,
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it is appropriate to infer that skilled
services are being provided.
We propose in § 409.42(c)(1)(i) that in
the home health setting, management
and evaluation of a patient care plan is
considered a reasonable and necessary
skilled service only when underlying
conditions or complications are such
that only a registered nurse can ensure
that essential non-skilled care is
achieving its purpose.
Further, in § 409.42(c)(1)(i) we also
propose to clarify that to be considered
a skilled service, the complexity of the
necessary unskilled services that are a
necessary part of the medical treatment
must require the involvement of
licensed nurses to promote the patient’s
recovery and medical safety in view of
the overall condition. Where nursing
visits are not needed to observe and
assess the effects of the nonskilled
services being provided to treat the
illness or injury, skilled nursing care
would not be considered reasonable and
necessary, and the management and
evaluation of the care plan would not be
considered a skilled service.
Additionally, we propose to further
clarify in § 409.42(c)(1)(i) that in some
cases, the condition of the patient may
require that a service that would
normally be considered unskilled be
classified as a skilled nursing service
given a patient’s unique circumstances.
This would occur when the patient’s
underlying condition or complication
required that only a registered nurse
could ensure that essential non-skilled
care was achieving its purpose. The
registered nurse would ensure that
services were safely and effectively
performed. However, any individual
service would not be deemed a skilled
nursing service merely because it was
performed by or under the supervision
of a licensed nurse. Where a service can
be safely and effectively performed (or
self administered) by the average nonmedical person without the direct
supervision of a nurse, the service
cannot be regarded as a skilled service
although a nurse actually provided the
service.
Proposed New Paragraph
§ 409.42(c)(1)(ii)
Additionally, we also propose a new
§ 409.42(c)(1)(ii), which would clarify
when patient education services as
described in § 409.33(a)(3) constituted
skilled services in the home health
setting. Current § 409.32(a)(3) states that
patient education services are skilled
services if the use of technical or
professional personnel is necessary to
teach patient self-maintenance.
However, to address the concerns and
lack of clarity surrounding when
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educations services are skilled services
as described above, we are proposing to
add a new paragraph, § 409.42(c)(1)(ii).
In the home health setting, skilled
education services would be deemed to
no longer be needed when it became
apparent, after a reasonable period of
time, that the patient, family, or
caregiver could not or would not be
trained. Further teaching and training
would cease to be reasonable and
necessary in this case, and would cease
to be considered a skilled service.
Notwithstanding that the teaching or
training was unsuccessful, the services
for teaching and training would be
considered to be reasonable and
necessary prior to the point that it
became apparent that the teaching or
training was unsuccessful, as long as
such services were appropriate to the
patient’s illness, functional loss, or
injury.
Proposed Change to § 409.44(b)
We are proposing to revise the
introductory material at § 409.44(b)(1),
to refer to the newly proposed
limitations of skilled services in the
home health benefit at § 409.42(c)(1)(i)
and 409.42(c)(1)(ii). The clauses under
the revised paragraphs (i) through (iv)
would remain unchanged.
Proposed Revision to § 424.22(a)(1)(i)
and § 424.22(b)(2)
We also propose to revise
§ 424.22(a)(1)(i) and § 424.22(b)(2) to
require a written narrative of clinical
justification on the physician
certification and recertification for the
targeted condition where the patient’s
overall condition supports a finding that
recovery and safety could be ensured
only if the care was planned, managed,
and evaluated by a registered nurse. We
believe that this revision would address
HHAs’ questions regarding the specific
circumstances which would necessitate
the need for skilled management and
evaluation of the care plan.
Additionally, we believe this
requirement would be an important step
in enhancing the physician
accountability and involvement in the
patient’s plan of care.
As we described above, many
Medicaid State Agencies and HHAs
contend that there is confusion as to
when overall management and
evaluation of a care plan constitute a
skilled service. They questioned what
specific beneficiary underlying
conditions, or complications or
circumstances would warrant a patient
who was receiving unskilled services to
need care plan management and
evaluation by a registered nurse, thus
rendering the care skilled. To clarify for
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home health agencies what specific
circumstances would necessitate the
involvement of a registered nurse in the
development, management, and
evaluation of a patient’s care plan when
only unskilled services are being
provided, we propose additions to the
home health certification content
requirements as described at
§ 424.22(a)(i) and recertification content
requirements at § 424.22(b)(2).
Specifically, when a patient’s
underlying condition or complication
requires exclusively that a registered
nurse ensure that essential non-skilled
care is achieving its purpose, and
necessitates a registered nurse be
involved in the development,
management, and evaluation of a
patient’s care plan, we propose to
require the physician include a written
narrative on the certification and
recertification describing the
physician’s clinical justification of this
need.
In the Physician Fee Schedule
proposed rule published in the July 7,
2008 Federal Register (73 FR 38578), we
solicited comments asking the industry
to suggest options to enhance contact
between the physician and the patient.
In that solicitation of comments, we
described policy options that we had
been considering such as a review of the
RVUs associated with the certification
and recertification of the HH plan of
care (POC), and that we were
considering proposing new
requirements, for example, a
requirement for ‘‘direct’’ patient contact
with the physician, to ensure more
active physician involvement in the
certification and recertification of the
HH POC.
As a result of this solicitation, some
commenters suggested that CMS
establish documentation expectations
associated with the certification and
recertification of the need for Medicare
home health services. We are continuing
to consider policy options to enhance
the physician-patient interaction in the
home health setting. We believe that the
commenters’ suggestion that CMS
establish documentation expectations
associated with the certification and
recertification, such as our proposed
clinical justification narrative
requirement, may be a first step in
achieving this goal.
Finally, we believe that this new
requirement would increase physician
accountability and oversight of the
certification and recertification of home
health services and plan of care by
focusing attention on the physician’s
responsibility to set out the clinical
basis for this skilled need as indicated
in the patient’s medical record.
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This brief narrative could be written
or typed on the certification form itself.
We do not believe that this brief
narrative should be allowed as an
attachment to the certification form
because an attachment could easily be
prepared by someone other than the
physician, and what we are seeking is
more direct involvement on part of the
physician. We seek comments on
whether this proposed requirement
would increase physician engagement
in the certification and recertification
process, and clarify industry confusion
associated with when a patient’s
condition would require the need for a
registered nurse to oversee the patient’s
care plan, thus rendering such ‘‘skilled
care’’ under our payment system.
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F. OASIS for Significant Change in
Condition: No Longer Associated With
Payment
We propose to remove an obsolete
reference to ‘‘new case-mix
assignments’’ as a result of significant
changes in a patient’s condition that
appears in 42 CFR 484 subpart E at
§ 484.55(d)(1)(ii). The significant change
in condition (SCIC), as it relates to new
case-mix assignments affecting
payment, was an element of the HH PPS
at the time of its first implementation in
fiscal year 2000. However, as part of the
HH PPS payment refinements
implemented in CY 2008, we eliminated
the SCIC policy, and the assignment of
subsequent case-mix assignments under
the HH PPS. However, it should be
noted that it was not the SCIC payment
policy that required the HHA to perform
the assessment, but rather the
significant change in the patient’s
condition. We are not proposing to
change that requirement. A HHA would
still be required to perform an
assessment in the event that a patient
experienced a significant change in
condition. The proposed modification is
only that a new case-mix assignment is
no longer associated with this
assessment.
In addition, we propose to revise
§ 484.250 to delete an obsolete reference
to § 484.237. § 484.237 referred to the
SCIC payment policy and was removed
in the CY 2008 HH PPS final rule (72
FR 49879).
G. Proposed Payment Safeguards for
Home Health Agencies
The provisions contained in this
section are designed to: (1) Improve our
ability to verify that home health
agencies (HHAs) meet minimum
enrollment criteria; (2) ensure that
HHAs that are changing ownership meet
and continue to meet the Conditions of
Participation for HHAs found in 42 CFR
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Part 484; and (3) improve the quality of
care that Medicare beneficiaries receive
from HHAs.
1. Program Integrity Concerns Involving
Home Health Agencies (HHAs)
The fraudulent business practices of
certain HHAs continue to cost the
Medicare program millions of dollars
nationwide. This issue was discussed in
a recent report issued by the
Government Accountability Office
(GAO) entitled ‘‘Improvements Needed
to Address Improper Payments in Home
Health’’ (GAO–09–185). This report,
discussed in more detail below,
concluded, in part, that ‘‘In the absence
of greater prevention, detection, and
enforcement efforts, the Medicare home
health benefit will continue to be a
ready target for fraud and abuse.’’
The problem has been especially
acute in, though by no means limited to,
the States of Texas and California. In
Los Angeles County in California, for
instance, the amount of money for
which HHAs in that county billed
Medicare between Fiscal Years 2003
and 2006 rose from $569 million to $921
million–an increase of 62 percent, and
one that was not accompanied by a
similar increase in the county’s
Medicare beneficiary population. There
has also been an abnormal proliferation
of HHAs in California as a whole.
Between October 2002 and May 2007,
the number of HHAs in the State rose
by 25 percent—again, without a
concomitant upswing in the number of
Medicare beneficiaries in California.
This suggests that there may also be an
increase in improper billing. HHA
proliferation has been an even bigger
problem in Texas. Between October
2002 and October 2006, the number of
HHAs in the State doubled, while—
during this same period—the number of
HHAs in Harris County, Texas (which
includes the city of Houston) increased
by almost 150 percent. As with
California, these figures are out of all
proportion with any increase in the
beneficiary population or demand for
HHA services in Texas or Harris County.
The aforementioned GAO report
expressed similar concerns. It noted
that, nationwide, ‘‘spending on the
Medicare home health benefit grew
about 44 percent from 2002 through
2006, despite an increase of just less
than 17 percent in the number of
beneficiaries using the benefit during
that 5-year period.’’ The report also
noted discrepancies in States other than
Texas and California. To illustrate,
between 2002 and 2006, the number of
HHAs that billed Medicare rose in
Florida by 100 percent, in Michigan by
62 percent, in Illinois by 59 percent, in
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Ohio by 42 percent, in Arizona by 32
percent, and in the District of Columbia
by 67 percent. However, the increases in
the number of Part A beneficiaries who
used HHA services in these six
jurisdictions were as follows: Florida—
28 percent; Michigan—19 percent;
Illinois—23 percent; Ohio—14 percent;
Arizona—4 percent; and the District of
Columbia—2 percent.
The disparity in many jurisdictions
between the increase in the number of
HHAs and the rise in the number of
beneficiaries is so overwhelming that it
cannot be attributed solely to an aging
populace. The fact that, as shown above,
between 2002 and 2006, the number of
HHAs in Arizona rose at a rate 8 times
greater than the number of Part A
beneficiaries that use HHA services—
and that the rate was an astounding 33
times greater in Washington, DC—must
raise serious questions as to the
legitimacy of some of these entities.
The GAO report also outlined a
number of instances of allegedly
fraudulent activities on the part of
HHAs. In a particularly glaring example
in Houston, Texas, the GAO noted the
following: ‘‘One PSC (Program
Safeguard Contractor) interviewed 670
Houston beneficiaries who had the most
severe clinical rating and who were
patients of HHAs identified by the PSC
as having aberrant billing patterns. The
PSC found 91 percent of claims for these
beneficiaries to be in error. Nearly 50
percent of the beneficiaries were not
homebound and therefore were not
eligible to receive any Medicare home
health services. The investigators also
found that while 39 percent of the
beneficiaries they interviewed were
eligible for the benefit, their clinical
severity had been exaggerated. The PSC
concluded that only 9 percent of claims
for the 670 beneficiaries were properly
coded. In addition, the PSC found that
other home health beneficiaries it
interviewed were not homebound; for
instance, some were mowing their
lawns when investigators came to
interview them.’’
Of particular concern to CMS is that
the problems discussed above have been
seen with HHAs on a far greater scale
than with any other type of certified
provider. The dramatic rise in the
number of HHAs in relation to the
increase in Medicare beneficiaries has
not been even remotely duplicated with
other Part A entities. In sum, the relative
level of potentially fraudulent behavior
among HHAs exceeds that of other
certified provider types, and it is for this
reason that CMS needs to take
additional steps to ensure that only
legitimate, bona fide HHAs remain
enrolled in the Medicare program.
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2. Prohibition on Sharing of Practice
Location
In 2008, we determined that a number
of HHAs had enrolled or attempted to
enroll into the Medicare program using
the same practice location or base of
operations listed in Section 4 of their
respective Medicare provider
enrollment applications. In one case, a
business attempted to enroll more than
twenty different HHAs with the same
Section 4 practice location as the base
of operations.
We believe that allowing HHAs to
share practice locations, operations, and
other aspects of the provider’s
operations (for example, patient and
financial records) in this manner
constitutes a significant risk to the
Medicare program. To allow an HHA to
share its Section 4 practice location or
base of operations with another
Medicare-enrolled HHA or supplier
limits the ability of CMS, a State survey
agency, or an accreditation organization
to ensure that each HHA meets the
Conditions of Participation specified at
42 CFR part 484. Indeed, pursuant to
Section 1866(j)(1)(A) of the Act, the
Secretary is required to establish by
regulation a process for the enrollment
of providers and suppliers into the
Medicare program. However, the
sharing of HHA practice locations or
bases of operations listed in Section 4 of
the Medicare provider enrollment
application hinders CMS’s ability to
properly enroll HHAs into Medicare
because of the extreme difficulty in
determining which site is in operation
at a particular time, and which provider
has control over the space, staff,
equipment, etc. We do not believe that
legitimate HHA providers share Section
4 practice locations or bases of
operations with another Medicareenrolled HHA or supplier.
At § 489.19, we are proposing a
provision that would prohibit an HHA
from sharing, leasing, or subleasing its
practice location or base of operations
listed in Section 4 of its Medicare
provider enrollment application with or
to another Medicare-enrolled HHA or
supplier. We believe that this provision
is consistent with existing provisions
found in § 410.33(g)(15), which
established limitations on the sharing of
space (that is, a practice location) by
independent diagnostic testing facilities
(IDTF).
At § 489.12(a)(5), we are proposing to
allow CMS to refuse to enter into a
provider agreement with a prospective
HHA if we determined, under proposed
42 CFR 489.19, that the HHA was
sharing, leasing, or subleasing its
practice location or base of operations
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listed in Section 4 of its Medicare
provider enrollment application with or
to another Medicare-enrolled HHA or
supplier.
At § 424.530(a)(8), we are proposing
to allow a Medicare contractor,
including a Regional Home Health
Intermediary or A/B MAC, to deny
Medicare billing privileges to an HHA if
it determined, under proposed 42 CFR
489.19, that the HHA was sharing,
leasing, or subleasing its practice
location or base of operations listed in
Section 4 of its Medicare provider
enrollment application with or to
another Medicare-enrolled HHA or
supplier.
At § 424.535(a)(11), we are proposing
to allow a Medicare contractor,
including a Regional Home Health
Intermediary or A/B MAC, to revoke the
Medicare billing privileges of an HHA
that it determined, under proposed 42
CFR 489.19, was sharing, leasing, or
subleasing its practice location or base
of operations listed in Section 4 of its
Medicare provider enrollment
application with or to another Medicareenrolled HHA or supplier.
We are, nevertheless, soliciting
comments on whether there are
legitimate business reasons for a
Medicare-enrolled HHA to share space
with another Medicare-enrolled HHA or
supplier when there is common
ownership. We are also soliciting
comments on whether there are
legitimate business reasons for a
Medicare-enrolled HHA to be co-located
with another Medicare-enrolled HHA or
supplier when there is no common
ownership. In addition, we are soliciting
comments on whether there are
legitimate business reasons for a
Medicare-enrolled HHA to engage in
leasing or subleasing arrangements with
a Medicare-enrolled supplier when
there is common ownership.
3. Sale or Transfer of Ownership Within
3 Years of Enrollment
We have recently found instances
where owners of a HHA, some of which
were working in concert with brokers or
organizations operating ‘‘turn-key’’
businesses, have enrolled or have
attempted to enroll in the Medicare
program for the specific purpose of
selling the Medicare billing privileges
and the Medicare provider agreement of
their HHA to a third-party. In this
scenario, the buyer or seller of the HHA
typically would notify Medicare of the
sale or change of ownership via the
Medicare enrollment application (CMS–
855A) after the billing privileges have
been transferred when the HHA is sold.
Current CMS policy recommends
surveys when there is a change of
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ownership. However, surveys in cases of
a change of ownership do not occur
with the frequency that they do when
providers initially enroll in Medicare.
Consequently, there are instances in
which a change of ownership takes
place yet the new owner does not
undergo a survey, in which case
Medicare cannot conclusively ascertain
whether the business, under new
ownership, meets the Conditions of
Participation under 42 CFR part 484.
This serves as an incentive for certain
prospective providers to enroll in the
Medicare program with the sole purpose
of transferring Medicare billing
privileges and the associated provider
agreement when the business is sold.
This is problematic for two reasons.
First, the prospective provider has
minimal incentive for ensuring quality
care for its patients after it is enrolled
because its exclusive objective for
participating in Medicare in the first
place is to sell the business shortly after
receiving Medicare billing privileges. In
other words, the provider, aware that it
may be able to sell the business without
the HHA having to undergo a survey,
may have little motivation to ensure that
it is in compliance with the Conditions
of Participation under 42 CFR part 484,
since it intends on selling the business
in any event. Medicare beneficiaries,
therefore, may receive inadequate
services as a result of this activity.
Second, without the protection that a
survey provides, the HHA may attempt
to bill Medicare for these insufficient
services. These circumstances increase
the risk for an HHA to submit
inappropriate and potentially fraudulent
claims to Medicare, which places the
Medicare Trust Funds at risk.
We further note that 42 CFR
424.550(a) states that a provider or
supplier ‘‘is prohibited from selling its
Medicare billing number or privileges to
any individual or entity, or allowing
another individual or entity to use its
Medicare billing number.’’ We believe
that the ‘‘turn-key’’ scenarios described
in this subsection 2 fall within the
general intent and purview of this
provision, in that the broker may focus
more on the selling of the HHA’s billing
privileges, rather than of the HHA itself.
Nevertheless, while the provisions of 42
CFR § 424.550(a) and (b) were designed
to prohibit this type of practice, we
cannot realistically enforce the
prohibitions on the sale, including an
asset sale or stock transfer, or transfer of
billing privileges, unless we can confirm
the nature of the financial arrangements
involved therein.
We recognize that the issue of a
potential lack of a survey in HHA
ownership changes exists with respect
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to other types of providers and certified
suppliers. Yet there are several reasons
as to why this concern is more acute
with HHAs than with other provider
types. First, and as already outlined in
subsection 1, the level of fraud in the
HHA sector appears to be more
prevalent than with other provider
categories. Second, CMS has not seen
the types of turn-key arrangements
described above with any type of
provider or certified supplier other than
HHAs. It is the combination of these two
factors that, in our view, make it
necessary for us to focus the proposed
provisions below on HHAs, rather than
on provider types with whom our
concerns are not nearly as acute. We
stress that CMS in the past has
undertaken a number of enrollment
initiatives to ensure that only eligible
and qualified providers and suppliers
obtain and maintain Medicare billing
privileges; specifically, CMS
promulgated rules to address fraud and
abuse and quality of care concerns for
IDTFs (in 42 CFR 410.33(g)) as well as
suppliers of durable medical equipment,
prosthetics, orthotics and supplies
(DMEPOS) (42 CFR 424.57(c)). We
therefore believe, for the reasons just
stated, that a similar approach is
warranted here with respect to HHAs.
With that said, and in view of the
aforementioned schemes that appear to
be designed to subvert Medicare’s
existing statutory and regulatory
authorities related to enrollment and
State survey procedures, we maintain
that additional tools are needed to
address this program vulnerability.
At 42 CFR 424.550(b)(1), we are
proposing that an HHA undergoing an
ownership change (including asset sales
and stock transfers) must obtain an
initial State survey or accreditation by
an approved accreditation organization
if the change takes place within 36
months after the effective date of the
HHA’s enrollment in Medicare. This
means that any change of ownership
that occurs during the 36 months
following an initial enrollment would
not result in the transfer of the HHA’s
provider agreement and Medicare
billing privileges to the new owner. The
new owner of the existing HHA would
instead be required to enroll in the
Medicare program as a new provider
under the provisions of § 424.510 and
obtain an initial State survey or
accreditation by an approved
accreditation organization. This is to
ensure that the HHA under new
ownership remains in compliance with
the Conditions of Participation in 42
CFR part 484. We believe that this will
help deter turn-key entities from
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purchasing HHAs for the sole purpose
of selling them, in that the facility will
be unable to undergo a change of
ownership within the above-referenced
36-month period without the HHA
being subject to a State survey.
We further believe that 36 months is
an appropriate period of time for which
to apply this requirement. It is long
enough to ensure that a newly-enrolled
HHA is serious about furnishing quality
services to Medicare beneficiaries and is
not merely looking to sell the HHA’s
Medicare billing privileges at the
earliest possible moment. Conversely, a
36-month timeframe is, in our view, not
so extensive as to greatly hinder the
ability of a bonafide HHA to sell its
business after the HHA has been
operational and providing legitimate
Medicare services for a reasonable
period of time. While we do recognize
that some legitimate, newly-enrolling
HHAs may be inconvenienced by their
inability to utilize, for a certain amount
of time, the change of ownership
provisions in 42 CFR 489.18, we also
stress that the aforementioned survey
requirement will, to a substantial extent,
benefit legitimate members of the HHA
provider community, in that it will help
ensure that unqualified HHAs are no
longer in the Medicare program. This
will, for bonafide HHAs, reduce
competition from less than legitimate
HHAs and, on a larger level; help
protect the Medicare Trust Funds.
Finally, if adopted, we believe that
any change of ownership (including
asset sales or stock transfers) that is
pending a Medicare contractor’s review
and approval at the time this rule
becomes effective, would be subject to
this provision.
4. Home Health Agency Reactivations of
Medicare Billing Privileges
In order to help address CMS’
concerns about potentially
inappropriate activity by HHAs, an
additional tool that we therefore believe
is necessary to help stem this behavior
involves enhanced safeguards for use as
part of the reactivation process
identified in § 424.540(a).
To ensure that HHAs whose Medicare
billing privileges have been deactivated
for 12 months of non-billing and who
seek to reactivate these privileges are
still in compliance with the Conditions
of Participation in 42 CFR part 484, we
propose to revise § 424.540(b)(3) from
its current form, ‘‘Reactivation of
Medicare billing privileges does not
require a new certification of the
provider or supplier by the State survey
agency or the establishment of a new
provider agreement’’ to ‘‘With the
exception of home health agencies,
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reactivation of Medicare billing
privileges does not require a new
certification of the provider or supplier
by the State survey agency or the
establishment of a new provider
agreement.’’ We are also proposing to
add § 424.540(b)(3)(i), which states that
any HHA whose Medicare billing
privileges are deactivated under the
provisions found in § 424.540(a) are also
required to obtain an initial State survey
or accreditation by an approved
accreditation organization before its
Medicare billing privileges can be
reactivated.
As already explained, CMS remains
concerned about the excessive level of
potentially inappropriate activity in the
HHA arena. To this end, CMS believes
that the proposed provisions outlined in
this subsection will, for reasons already
identified, help address the concerns
outlined in the aforementioned GAO
report by ensuring that HHAs are in
constant and verifiable compliance with
the HHA Conditions of Participation
found in 42 CFR part 484, and that only
qualified and legitimate home health
providers are enrolled in Medicare.
H. Physician Certification and
Recertification of the Home Health Plan
of Care
a. Background
Sections 1814(a)(2)(C) and
1835(a)(2)(A) of the Act require that a
plan for furnishing home health services
be established and periodically
reviewed by a physician in order for
Medicare payments for those services to
be made. Our regulations at § 409.43(e)
specifically states that a home health
plan of care (HH POC) must be
reviewed, signed, and dated by the
physician who reviews the POC (as
specified in § 409.42(b)) in consultation
with agency clinical staff at least every
60 days (or more frequently as specified
in § 409.43(e)(1)). Additionally,
§ 424.22(b) states that a recertification is
required at least every 60 days,
preferably at the time the plan is
reviewed, and must be signed by the
physician who reviews the home health
POC. These schedules, for the review of
the POC and the recertification,
coordinate well with the 60-day episode
payment unit under the HH PPS. In
implementing the statutory requirement
as well as these regulations, we believed
that these requirements would
encourage enhanced physician
involvement in the HH POC and patient
management, and would include more
direct ‘‘in-person’’ patient encounters
(as logistically feasible).
Currently, physicians are paid for
both the certification and recertification
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of the HH POC under HCPCS codes
G0180 and G0179, respectively. The
basis for the payment amounts of these
physician services is the relative
resources in RVUs required to furnish
these services. We believe physician
involvement is very important in
maintaining quality of care under the
HH PPS.
In the HH PPS proposed rule
published in the October 28, 1999
Federal Register (64 FR 58196), we had
proposed to require the physician to
certify the case-mix weight/home health
resource group (HHRG) as part of the
required physician certification of the
POC. This reflected our belief that the
physician should be more involved in
the decentralized delivery of home
health services. However, in the final
rule published in the July 3, 2000
Federal Register (65 FR 41163), we did
not finalize that proposal and decided to
focus our attention on physician
certification and education in order to
better involve the physician in the
delivery of home health services.
b. Solicitation of Comments
It has come to our attention that
physician involvement in the
certification and recertification of HH
POC varies greatly. While some
physicians have direct contact with
their patients in the delivery of home
health services, we believe that a
significant number of physicians
provide only a brief, albeit thorough,
review of the HH POC, without any
direct contact with the patient. We
continue to believe that active
involvement of the physician, including
‘‘in-person’’ contact with the patient,
during the certification and
recertification of the HH POC is
essential for the delivery of high quality
HH services.
In the Physician Fee Schedule
proposed rule published in the July 7,
2008 Federal Register (73 FR 38578), we
mentioned several options to enhance
direct contact between the physician
and the patient. First, we considered a
review of the RVUs associated with the
certification and recertification of the
HH POC. As a result of that review, the
payment amounts to physicians could
be reduced based on a more accurate
determination of the actual RVUs
required to provide these services. We
also considered proposing new
requirements; for example, a
requirement for ‘‘direct’’ patient contact
with the physician, to ensure more
active physician involvement in the
certification and recertification of the
HH POC. We specifically solicited
comments on these policy options. The
following is a summary of the comments
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17:40 Aug 05, 2009
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and our responses as published in the
Physician Fee Schedule final rule
published in the November 19, 2008
Federal Register (73 FR 69855).
Most commenters suggested that we
leave our current policies and payment
to physicians unchanged, at least until
further analysis is completed. To that
end, it was suggested that we continue
to study the role of the physician in
home care and determine which factors
enhance a physician’s ability to conduct
oversight activities, ensure
appropriateness of care, and work
collaboratively with HHAs without
further burdening Medicare
beneficiaries. Commenters urged CMS
to engage with industry organizations
that represent the physicians that
furnish these services, to determine
goals and assess options. Commenters
further suggested that goals and options
could include revising the procedure
codes used for billing, assessing the
current RVUs, and establishing
documentation expectations.
Some commenters suggested that
payments to physicians for certifying
and recertifying HH POCs should be
restructured to provide incentives for
greater physician involvement, to
include personally seeing the patients.
Specifically, some commenters
suggested adding different payments for
the varying levels of physician
involvement in the certification and
recertification of HH POCs. Other
commenters urged CMS to consider how
home telehealth can be employed to a
greater degree to increase input of
clinical information directly to
physicians in lieu of face-to-face
contact.
Other commenters suggested that we
actively support amending the Medicare
statute to allow nurse practitioners
(NPs) to certify and recertify HH POCs.
Some commenters suggested that we
actively support demonstrations and
legislative proposals to build on the
concept of merging home care with
primary care under a single care
management entity for persons in the
advanced stages of chronic illnesses.
Other commenters suggested that
payment to medical directors should be
restored to HHAs, along with
requirements for their education and a
definition of their role, and that we
consider reimbursement for a planning
teleconference between the physician
and home health personnel.
In the November 19, 2008 final rule,
we expressed our appreciation for the
comments and responded that we
would continue to analyze and consider
the comments and suggestions in future
rulemaking. Additionally, as a result of
comments received on the above
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39461
physician rule, as it relates to physicianpatient contact, we are considering the
possibility of requiring physicians to
make phone calls to patients at various
times over the course of home health
treatment (prior to recertifications), as a
means to promote that physician-patient
contact and to help ensure the delivery
of high quality HH services to our
beneficiaries.
In this HH PPS proposed rule for CY
2010, we are specifically soliciting
additional comments on this topic.
I. Routine Medical Supplies
HHAs have expressed to the HHS
Office of the Inspector General (OIG)
some confusion regarding routine
medical supplies and how we account
for the cost of those supplies. Therefore,
we would like to reiterate our policy
regarding routine medical supplies and
how they are reimbursed under the HH
PPS.
Section 1895(b)(1) states that ‘‘all
services covered and paid on a
reasonable cost basis under the
Medicare home health benefit as of the
date of the enactment of this section,
including medical supplies, shall be
paid for on the basis of a prospective
payment amount * * *.’’ The cost of
routine medical supplies was included
in the average cost-per-visit amounts
derived from the audit sample. These
average cost-per-visit amounts were
used to calculate the initial HH PPS
rates published in the July 3, 2000 HH
PPS final rule (FR 65 41184). Because
reimbursement for routine medical
supplies is bundled into the HH PPS 60day episode rate and the per-visit rates,
HHAs may not bill separately for
routine supplies.
As noted in Chapter 7—Home Health
Services of the Medicare Benefit Policy
Manual (Pub. 100–02), sections 50.4.1.2
and 50.4.1.3, routine supplies are
supplies that are customarily used in
small quantities during the course of
most home care visits. They are usually
included in the staff’s supplies and not
designated for a specific patient.
Routine supplies would not include
those supplies that are specifically
ordered by the physician or are essential
to HHA personnel in order to effectuate
the plan of care. Examples of supplies
which are usually considered routine
include, but are not limited to:
A. Dressings and Skin Care
• Swabs, alcohol preps, and skin prep
pads;
• Tape removal pads;
• Cotton balls;
• Adhesive and paper tape;
• Nonsterile applicators; and
• 4 X 4’s.
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B. Infection Control Protection
•
•
•
•
Nonsterile gloves;
Aprons;
Masks; and
Gowns.
C. Blood Drawing Supplies
• Specimen containers.
D. Incontinence Supplies
• Incontinence briefs and Chux
covered in the normal course of a visit.
For example, if a home health aide in
the course of a bathing visit to a patient
determines the patient requires an
incontinence brief change, the
incontinence brief in this example
would be covered as a routine medical
supply.
E. Other
• Thermometers; and
• Tongue depressors.
There are occasions when the
supplies listed in the above examples
would be considered non-routine and
thus would be considered a billable
supply, i.e., if they are required in
quantity, for recurring need, and are
included in the plan of care. Examples
include, but are not limited to, tape, and
4 X 4s for major dressings.
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IV. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 60Day notice in the Federal Register and
solicit public comment before a
collection of information (COI)
requirement is submitted to the Office of
Management and Budget (OMB) for
review and approval. In order to fairly
evaluate whether an information
collection should be approved by OMB,
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
information collection requirements
(ICRs):
A. ICRs Regarding the Requirements for
Home Health Services
Section 424.22 proposes that if a
patient’s underlying condition or
complication required a registered nurse
to ensure that essential non-skilled care
was achieving its purpose, and
necessitated a registered nurse be
involved in the development,
management, and evaluation of a
patient’s care plan, the physician would
include a written narrative describing
the clinical justification of this need.
The burden associated with this
requirement would be the time and
effort put forth by the physician to
include the written narrative. We
estimate it would take one physician
approximately 5 minutes to meet this
requirement. We estimate the frequency
of such a situation to occur in about 5
percent of episodes (or about 345,600
episodes a year); therefore, the total
annual burden associated with this
requirement would be 28,800 hours for
CY 2010.
B. ICRs Regarding Deactivation of
Medicare Billing Privileges
In the proposed § 424.540(b)(3)(i), an
HHA whose Medicare billing privileges
are deactivated under the provisions
found in 424.540(a) must obtain an
initial State survey or accreditation by
an approved accreditation organization
before its Medicare billing privilege can
be reactivated. The burden associated
with this requirement would be the time
and effort put forth by the HHA to
obtain a State survey or accreditation.
We estimate it would take the
prospective provider/owner 60 hours to
obtain a State survey or accreditation.
We estimate that there would be 2,000
such occurrences annually; therefore,
the total annual burden associated with
this requirement would be 120,000
hours.
C. ICRs Regarding Prohibition Against
Sale or Transfer of Billing Privileges
At § 424.550(b)(1) we propose that an
HHA undergoing an ownership change
would have to obtain an initial State
survey or accreditation by an approved
accreditation organization if the change
takes place within 36 months after the
effective date of the HHA’s participation
in Medicare. Between April 2008 and
April 2009, approximately 2,000
Medicare-enrolled HHAs—or 22.5
percent of the 9,000 total number of
HHAs enrolled in Medicare—underwent
a change of ownership. Naturally, the
Number of Requirements
None .......................................
424.22 .....................................................................................
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D. ICRs Regarding Patient Assessment
Data
Section 484.210 would require an
HHA to submit to CMS the OASIS data
described at § 484.55(b)(1) and (d)(1) in
order for CMS to administer the
payment rate methodologies described
in §§ 484.215, 484.230 and 484.235.
The burden associated with this is the
time and effort put forth by the HHA to
submit the OASIS data. This burden is
currently accounted for under OMB#
0938–0761.
Number of
respondents
OMB No.
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magnitude of the ownership changes
varied by HHA, but the fact that almost
one-quarter of all Medicare-enrolled
HHAs changed ownership in some form
within the past year is, for the reasons
outlined in the preamble to this
proposed rule, significant.
It is also important to note that of the
2,000 ownership changes,
approximately 20 percent occurred in
Texas, another 20 percent in Florida,
and 14 percent in California, meaning
that over one-half of all changes in
ownership occurred in three States.
Though it is possible that, if this
provision was implemented, the number
of total annual ownership changes
would decrease, we will assume that the
figure of 2,000 would remain constant.
The burden associated with the
proposed requirement in § 424.550(b)(1)
would be twofold. First, the HHA would
need to complete and submit a Medicare
enrollment application (paper or
electronic) as an initial applicant. This
can be done electronically via the
Internet-Based Provider Enrollment,
Chain and Ownership System (PECOS)
or by using the paper CMS–855
enrollment application. The estimated
burden of completing the entire
application as a new enrollee is 3 hours.
Thus, the estimated annual burden for
the approximately 2,000 HHAs that will
change ownership would be 6,000
hours. Second, the provider would need
to undergo a survey (or obtain
accreditation in lieu of a survey) and
perform administrative activities
associated therewith. We estimate that
the total hourly burden to the HHA for
said activities would be 60 hours, for an
annual burden of 120,000 hours (2,000
HHAs × 60 hours). Therefore, we
estimate that the total annual burden of
compliance with § 424.550(b)(1) would
be 126,000 hours (120,000 hours + 6,000
hours).
345,600
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Burden hours
⁄
1 12
Total annual
burden hours
28,800
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Number of
respondents
OMB No.
Number of Requirements
None .......................................
None .......................................
0938–0761 ..............................
424.540(a)(3)(i) .......................................................................
424.550(b)(1) ..........................................................................
484.210 ...................................................................................
1 Not
60
63
(1)
Total annual
burden hours
120,000
126,000
(1)
applicable.
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 this 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–
1560–P.
Fax: (202) 395–6974; or
E-mail:
OIRA_submission@omb.eop.gov
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
2,000
2,000
(1)
Burden hours
E. ICRs Regarding Annual Update of the
Unadjusted National Prospective 60-day
Episode Payment Rate
Section 484.225(i) requires the
submission of quality measures as
specified by the Secretary. As part of
this requirement, each HHA sponsoring
a Home Health Care CAHPS
(HHCAHPS) Survey must prepare and
submit to its survey vendor a file
containing patient data on patients
served the preceding month that will be
used by the survey vendor to select the
sample and field the survey. This file
(essentially the sampling frame) for
most home health agencies can be
generated from existing databases with
minimal effort. For some small HHAs,
preparation of a monthly sample frame
may require more time. However, data
elements needed on the sample frame
will be kept at a minimum to reduce the
burden on all HHAs.
The burden associated with this
requirement is the time and effort put
forth by the HHA to prepare and submit
the file containing patient data on
patients. The survey instrument and
procedures for completing the
instrument are designed to minimize
burden on all respondents. No
significant burden is expected for small
agencies beyond providing their
contracted vendor with a monthly file of
patients served.
Initially, we estimate it would take
one HHA 5 hours for the first month to
meet this requirement. The subsequent
monthly burden is estimated to be 30
minutes per HHA. We estimate
approximately 7,000 HHAs would be
submitting this data annually. Based on
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17:40 Aug 05, 2009
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that number, the burden associated with
the first month is estimated at 35,000
hours. The burden would decrease to
2,100 for subsequent months. Therefore,
the total annual burden for the first year
would total 58,100.
The burden associated with the home
health patient’s submission of the
HHCAHPS survey is currently pending
OMB approval (CMS–10275/OMB#
0938–NEW). Once OMB approval has
been obtained, CMS will revise the
package to include the burden on the
HHAs as discussed above.
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
VI. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of this
proposed rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993 as
further amended) the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), section 1102(b) of
the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4), Executive Order
13132 on Federalism (August 4, 1999)
and the Congressional Review Act (5
U.S.C. 804(2)).
Executive Order 12866 (as amended
by Executive Order 13258) directs
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). A regulatory impact
analysis (RIA) must be prepared for
rules with economically significant
effects ($100 million or more in any 1
year). We estimate that this rulemaking
is ‘‘economically significant’’ as
measured by the $100 million threshold
and hence also a major rule under the
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Congressional Review Act. Accordingly,
we have prepared a Regulatory Impact
Analysis, that to the best of our ability,
presents the costs and benefits of the
rulemaking.
1. HHA Provisions Regarding CoMingling, Ownership Changes, and
Reactivation of Billing Privileges
We believe that our proposals
regarding: (1) The prohibition against
co-mingling, (2) HHA changes of
ownership, and (3) the reactivation of
HHA billing privileges would have
minimal budgetary impact, as the total
number of entities that will be effected
each year would be small. Moreover, we
believe that these changes are necessary
to ensure that currently enrolled and
prospective HHAs are billing for the
services provided and are in compliance
with the conditions of participation in
42 CFR part 484, and all other Medicare
requirements.
As for the issue of beneficiary access,
the number of affected HHAs is such
that we do not believe that beneficiaries
would be adversely impacted by the
proposed provisions. To the contrary,
any reduction in the number of enrolled
HHAs that would result from the
implementation of these proposed
provisions would be more than offset by
the assurance that those HHAs that
cannot meet Medicare requirements and
quality standards are no longer in the
program.
We are unable to determine the exact
extent to which currently enrolled and
prospective HHAs would be able to
meet the requirements outlined in the
proposed provisions. In addition, as a
result of a dearth of quantifiable data,
we cannot effectively derive an estimate
of the monetary impacts of these
provisions. Accordingly, we are seeking
public comment so that the public may
provide any data available that provides
a calculable impact or any alternative to
the proposed provisions.
1. CY 2010 Update
The update set forth in this proposed
rule applies to Medicare payments
under HH PPS in CY 2010. Accordingly,
the following analysis describes the
impact in CY 2010 only. We estimate
that the net impact of the proposals in
this rule, including a 2.75 percent
reduction to the national standardized
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60-day episode payment rates and the
NRS conversion factor to account for the
case-mix change adjustment, is
approximately $100 million in CY 2010
savings. The estimated $100 million
impact reflects the distributional effects
of an updated wage index (¥$10
million) as well as the 2.2 percent home
health market basket increase (an
additional $390 million in CY 2010
expenditures attributable only to the CY
2010 home health market basket), and
the 2.75 percent decrease (¥$480
million for the third year of a 4-year
phase-in) to the HH PPS national
standardized 60-day episode rate to
account for the case-mix change
adjustment under the HH PPS. The $100
million is reflected in column 5 of Table
8 as a 0.86 percent decrease in
expenditures when comparing the
current CY 2009 system to the CY 2010
system. If the Secretary were to impose
a 6.89 percent decrease to the national
standardized 60-day episode rates and
the NRS conversion factor in CY 2010,
to account for the increase in nominal
case-mix, the impact would be an
estimated decrease in payments to
HHAs of 4.9 percent (column 3 of Table
8) or $1,220 million. Similarly, if the
Secretary were to impose a 3.51 percent
decrease to the national standardized
60-day episode rates and the NRS
conversion factor in CY 2010, to account
for the increase in nominal case-mix,
the impact would be an estimated
decrease in payments to HHAs of 1.6
percent (column 4 of table 8) or $590
million. For comparison purposes,
estimated impacts that take these
alternative percentage reductions (6.89
percent and 3.51 percent) into account
can be found in columns 3 and 4 of
Table 8 in Section VI.B. of this rule.
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $7 million to $34.5 million in any 1
year. For the purposes of the RFA,
approximately 75 percent of HHAs are
considered to small businesses
according to the Small Business
Administration’s size standards with
total revenues of $13.5 million or less in
any 1 year. Individuals and States are
not included in the definition of a small
entity. Excluding HHAs in areas of the
country where high and suspect outlier
payments exist, this proposed rule is
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estimated to have an overall positive
effect upon small entities (see section
IB.B ‘‘Anticipated Effects’’, of this
proposed rule, for supporting analysis).
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. This proposed rule
applies to home health agencies.
Therefore, the Secretary has determined
that this proposed rule will not have a
significant economic impact on the
operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of about $100 million or
more in 1995 dollars, updated for
inflation. That threshold is currently
approximately $133 million in 2009.
This proposed rule is not anticipated to
have an effect on State, local, or tribal
governments, in the aggregate, or by the
private sector, of $133 million or more.
Executive Order 13132 established
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
We have reviewed this proposed rule
under the threshold criteria of Executive
Order 13132, Federalism, and have
determined that it would not have
substantial direct effects on the rights,
roles, and responsibilities of States,
local, or tribal governments.
B. Anticipated Effects
This proposed rule sets forth updates
to the HH PPS rates contained in the CY
2009 notice (73 FR 65351, November 3,
2008). The impact analysis of this
proposed rule presents the estimated
expenditure effects of policy changes
proposed in this rule. We use the latest
data and best analysis available, but we
do not make adjustments for future
changes in such variables as number of
visits or case-mix.
This analysis incorporates the latest
estimates of growth in service use and
payments under the Medicare home
health benefit, based on Medicare
claims from 2007. We note that certain
events may combine to limit the scope
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or accuracy of our impact analysis,
because such an analysis is futureoriented and, thus, susceptible to errors
resulting from other changes in the
impact time period assessed. Some
examples of such possible events are
newly-legislated general Medicare
program funding changes made by the
Congress, or changes specifically related
to HHAs. In addition, changes to the
Medicare program may continue to be
made as a result of the BBA, the BBRA,
the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection
Act of 2000, the MMA, the DRA, or new
statutory provisions. Although these
changes may not be specific to the HH
PPS, the nature of the Medicare program
is such that the changes may interact,
and the complexity of the interaction of
these changes could make it difficult to
predict accurately the full scope of the
impact upon HHAs.
Table 8 represents how home health
agency revenues are likely to be affected
by the policy changes described in this
rule. For this analysis, we used linked
home health claims and OASIS
assessments; the claims represented a
20-percent sample of 60-day episodes
occurring in CY 2007. Column one of
this table classifies HHAs according to
a number of characteristics including
provider type, geographic region, and
urban versus rural location.
For the purposes of analyzing impacts
on payments, we performed three
simulations and compared them to each
other. Based on our assumption that
outliers, as a percentage of total HH PPS
payments, will be no more than 5
percent in CY 2009, the 2009 baseline,
for the purposes of these simulations,
we assumed that the full 5 percent
outlay for outliers will be paid under
our policy in 2009 of a 0.89 FDL ratio.
As described in section III.A. of this
proposed rule, given our proposed
policies of a 0.67 FDL ratio and a 10
percent cap on outlier payments, we
would return 2.5 percent back into the
national standardized 60-day episode
payment rates, the national per-visit
rates, the LUPA add-on payment
amount, and the NRS conversion factor,
and then estimate outlier payments to
be approximately 2.5 percent of total
HH PPS payments in CY 2010. All three
simulations use a CBSA-based wage
index reported on the 2007 claims to
determine the appropriate wage index.
The first simulation estimates CY
2009 payments under the current
system (to include the 2009 wage
index). The second simulation estimates
CY 2009 payments under the current
system, but with the 2010 wage index.
The second simulation produces an
estimate of what total payments using
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Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules
the sample data would have been in CY
2009 without any of the proposed
provisions in this rule, except for that of
the 2010 wage index. The third
simulation estimates CY 2010 payments
with the 2010 wage index, incorporating
our maintaining of the 2.75 percent
reduction to the HH PPS rates, as well
as all the proposed provisions of this
rule.
These simulations demonstrate the
effects of: A new 2010 wage index, a
2.75 percent reduction to account for
the increase in nominal case-mix, a 2.2
percent market basket update, a 2.5
percent increase to account for a new
outlier target of 2.5 percent, a 0.67 FDL
ratio, and a 10 percent cap on outlier
payments. Specifically, the second
column of Table 8 shows the percent
change due to the effects of the 2010
wage index. The third and fourth
columns are for comparison purposes,
and show the percent change due to the
combined effects of the 2010 wage
index, an alternative 6.89 percent
reduction (column 3) or an alternative
3.51 percent reduction (column 4) to the
rates to account for the increase in
nominal case-mix, the 2.2 percent home
health market basket update, the 2.5
percent increase to the HH PPS rates to
account for an approximate 2.5 percent
target for outliers as a percentage of total
HH PPS payments, a 0.67 FDL ratio, and
a 10 percent outlier cap. The fifth
column of Table 8 shows the percent
change due to the combined effects of
the 2010 wage index, our maintaining of
a 2.75 percent reductions to the rates to
account for the increase in nominal
case-mix, the 2.2 percent home health
market basket update, the 2.5 percent
increase to the HH PPS rates to account
for an approximate 2.5 percent target for
outliers as a percentage of total HH PPS
payments, a 0.67 FDL ratio, and a 10
percent outlier cap.
The overall percentage change, for all
HHAs, in estimated total payments from
CY 2009 to CY 2010 is a decrease of
approximately 0.86 percent. Rural
HHAs, however, are estimated to see an
increase in payments from CY 2009 to
CY 2010 of about 3.45 percent. On the
other hand, urban HHAs are expected to
see a decrease of approximately 1.64
percent in payments from CY 2009 to
CY 2010.
Voluntary non-profit HHAs (3.52
percent), facility-based HHAs (3.90
percent), and government owned HHAs
(3.11 percent) are estimated to see an
increase in the percentage change in
estimated total payments from CY 2009
to CY 2010. Proprietary and
freestanding HHAs, on the other hand,
are estimated to see decreases of 3.14
percent and 1.73 percent, respectively,
in estimated total payments from CY
2009 to CY 2010. Freestanding HHAs,
broken out, show that voluntary nonprofit and governmental HHAs are
estimated to see increases of 3.22
percent and 2.63 percent, respectively,
in estimated total payments from CY
2009 to CY 2010.
HHAs in the North and Midwest
regions are expected to experience a
percentage change increase in the
estimated total payments from CY 2009
to CY 2010 of 3.79 percent and 3.67
percent, respectively. HHAs in the
South and West regions of the country
are estimated to experience decreases in
the percentage change in estimated total
payments from CY 2009 to CY 2010 of
39465
4.01 percent and 1.52 percent. We
believe that the major contributors to
the estimated decreases in payments in
these areas of the country are those with
high and suspect outlier payments.
Breaking this down even further, it is
estimated that New England, Mid
Atlantic, East South Central, East North
Central, and West North Central area
HHAs are all expected to experience
increases in their payments in CY 2010
ranging from just over 2 percent to
almost 5 percent. Conversely, South
Atlantic and Pacific HHAs are expected
to experience decreases, 11.68 percent
and 2.90 percent respectively, in the
percentage change in estimated total
payments from CY 2009 to CY 2010.
Again, we believe that the major
contributors to the estimated decreases
in payments in these areas of the
country are those with high and suspect
outlier payments.
Larger HHAs (those with 200 or more
Medicare home health initial episodes
per year) are estimated to experience an
increase in payments from CY 2009 to
CY 2010 of approximately 2.44 percent.
Mid-size to small agencies are expected
to see a decrease in their payments in
CY 2010, ranging from 1.77 percent to
15.93 percent. However, we believe that
the major contributors to the estimated
decreases in payments for mid-size to
small agencies are those agencies in
areas of the country with high and
suspect outlier payments. Consequently,
we have provided a more detailed
discussion, and analysis in Table 9
below, that demonstrates where, in the
country, these estimated large decreases
for mid-size to small agencies are
occurring.
TABLE 8—IMPACT BY AGENCY TYPE
Comparisons
Percent change
due to the
effects of the
updated wage
index only
(percent)
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
Group
Type of Facility:
Free-Standing/Other Vol/NP .............................................
Free-Standing/Other Proprietary ......................................
Free-Standing/Other Government ....................................
Facility-Based Vol/NP .......................................................
Facility-Based Proprietary ................................................
Facility-Based Government ..............................................
Subtotal: Freestanding ..................................................
Subtotal: Facility-based .................................................
Subtotal: Vol/PNP ......................................................
Subtotal: Proprietary ..................................................
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¥0.01
¥0.05
¥0.32
¥0.12
¥0.22
¥0.27
¥0.05
¥0.15
¥0.06
¥0.05
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(For comparison
purposes)
Impact of CY
2010 proposed
policies 1
(w/alternative 6.89
percent reduction
in place of the
proposed 2.75
percent reduction)
(percent)
(For comparison
purposes)
Impact of CY
2010 proposed
policies 1
(w/alternative 3.51
percent reduction
in place of the
proposed 2.75
percent reduction)
(percent)
¥0.89
¥7.25
¥1.49
¥0.22
¥0.57
¥0.56
¥5.74
¥0.29
¥0.62
¥7.12
2.47
¥4.00
1.88
3.19
2.89
2.88
¥2.46
3.13
2.76
¥3.87
E:\FR\FM\06AUP2.SGM
06AUP2
Impact of
CY 2010
proposed
policies 1
(percent)
3.22
¥3.27
2.63
3.96
3.66
3.65
¥1.73
3.90
3.52
¥3.14
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Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules
TABLE 8—IMPACT BY AGENCY TYPE—Continued
Comparisons
Percent change
due to the
effects of the
updated wage
index only
(percent)
Group
(For comparison
purposes)
Impact of CY
2010 proposed
policies 1
(w/alternative 6.89
percent reduction
in place of the
proposed 2.75
percent reduction)
(percent)
(For comparison
purposes)
Impact of CY
2010 proposed
policies 1
(w/alternative 3.51
percent reduction
in place of the
proposed 2.75
percent reduction)
(percent)
Impact of
CY 2010
proposed
policies 1
(percent)
Subtotal: Government ...............................................
¥0.30
¥1.05
2.35
3.11
Total .......................................................................
Type of Facility
(Rural * Only):
Free-Standing/Other Vol/NP .............................................
Free-Standing/Other Proprietary ......................................
Free-Standing/Other Government ....................................
Facility-Based Vol/NP .......................................................
Facility-Based Proprietary ................................................
Facility-Based Government ..............................................
Type of Facility
(Urban * Only):
Free-Standing/Other Vol/NP .............................................
Free-Standing/Other Proprietary ......................................
Free-Standing/Other Government ....................................
Facility-Based Vol/NP .......................................................
Facility-Based Proprietary ................................................
Facility-Based Government ..............................................
Type of Facility
(Urban* or Rural*):
Rural .................................................................................
Urban ................................................................................
¥0.06
¥4.90
¥1.60
¥0.86
¥0.50
¥0.14
¥0.58
¥0.44
¥0.62
¥0.42
¥0.61
¥0.98
¥0.52
¥0.52
¥1.30
¥0.47
2.83
2.51
2.88
2.91
2.16
2.97
3.60
3.29
3.63
3.68
2.93
3.74
0.06
¥0.03
¥0.04
¥0.04
0.03
¥0.03
¥0.93
¥8.11
¥2.58
¥0.14
¥0.10
¥0.71
2.41
¥4.89
0.76
3.27
3.35
2.75
3.16
¥4.17
1.51
4.03
4.13
3.52
¥0.31
¥0.02
¥0.79
¥5.64
2.67
¥2.37
3.45
¥1.64
¥0.06
¥4.90
¥1.60
¥0.86
0.05
¥0.05
¥0.23
¥0.08
0.37
¥0.30
¥7.95
¥0.57
¥5.55
0.21
3.04
¥4.73
2.89
¥2.26
3.68
3.79
¥4.01
3.67
¥1.52
4.46
¥0.06
¥4.90
¥1.60
¥0.86
0.53
¥0.21
0.27
¥0.23
¥0.29
¥0.27
¥0.07
0.33
¥0.23
0.37
0.75
¥0.87
¥15.29
¥0.57
¥3.71
¥0.62
¥0.37
¥2.05
¥6.88
0.21
4.13
2.44
¥12.34
2.94
¥0.34
2.85
3.08
1.33
¥3.63
3.68
4.88
3.19
¥11.68
3.72
0.41
3.62
3.85
2.09
¥2.90
4.46
Total .......................................................................
Facility Location: Region*:
North .................................................................................
South ................................................................................
Midwest .............................................................................
West ..................................................................................
Outlying .............................................................................
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
Total .......................................................................
Facility Location:
Area of the Country:
New England ....................................................................
Mid Atlantic .......................................................................
South Atlantic ...................................................................
East South Central ...........................................................
West South Central ..........................................................
East North Central ............................................................
West North Central ...........................................................
Mountain ...........................................................................
Pacific ...............................................................................
Outlying .............................................................................
Total .......................................................................
Facility Size:
(Number of First Episodes):
< 19 ...................................................................................
20 to 49 ............................................................................
50 to 99 ............................................................................
100 to 199 ........................................................................
200 or More ......................................................................
¥0.06
¥4.90
¥1.60
¥0.86
0.12
0.03
¥0.04
¥0.13
¥0.07
¥19.43
¥15.28
¥12.79
¥5.79
¥1.70
¥16.57
¥12.29
¥9.72
¥2.51
1.69
¥15.93
¥11.62
¥9.04
¥1.77
2.44
Total .......................................................................
¥0.06
¥4.90
¥1.60
¥0.86
Note: Based on a 20% sample of CY 2007 claims linked to OASIS assessments.
* Urban/rural status, for the purposes of these simulations, is based on the wage index on which episode payment is based. The wage index is
based on the site of service of the beneficiary.
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39467
Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules
REGION KEY:
New England = Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle Atlantic = Pennsylvania, New Jersey,
New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia;
East North Central = Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Tennessee; West
North Central = Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central = Arkansas, Louisiana, Oklahoma, Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming; Pacific = Alaska, California, Hawaii, Oregon, Washington; Outlying = Guam, Puerto Rico, Virgin Islands
1 Percent change due to the effects of the update wage index, the 2.2% home health market basket update, the 2.75% reduction to
the national standardized episode rates, the national per-visit rates, the LUPA add-on payment amount, and the NRS conversion factor
for nominal increase in case-mix, the 2.5% increase in the rates due to the new approximate 2.5% target for outliers as a percentage of
total HH PPS payments, a 0.67 FDL ratio, and a 10% outlier cap
Given the overall large negative
impact observed by smaller agencies, we
performed more detailed analysis
targeted at identifying where the large
negative impacts were occurring. Table
9 below presents the results of the
regional analysis for small agencies.
Column 1, of Table 9, shows the
regional and agency size classifications
similar to those in Table 8. In column
2 we repeat the overall impacts (from
Table 8) for those classifications. In
columns 3 through 7, we drill down in
our analysis, looking at those
classifications by the size of the agency
(as defined by the number of first
episodes). It is clear from this analysis
that, for smaller agencies, the vast
majority of the negative impact is
occurring in areas of the country (such
as the South and South Atlantic) where
there exist high and suspect outlier
payments. Specifically, in columns 3, 4,
and 5 of Table 9, for the South Atlantic
area of the country (which includes
Miami-Dade, Florida), the negative
percentage impacts in payment ranging
from around 40 percent to just over 53
percent are evidence that it is the high
and suspect outlier payments in areas
such as this, that are skewing the results
of the overall impact analysis. Estimated
impacts for small agencies in the South
(negative impacts ranging around 15
percent to 22 percent) and the Pacific
(negative impacts ranging from around
11 percent to 17%) areas of the country,
reflect similar results. Conversely, small
HHAs in most other parts of the country
are estimated to see increases in
payments in CY 2010, ranging from 0.20
percent to almost 4.5 percent.
Consequently, we believe that small
HHAs without high and suspect outlier
payments, on average, will see a
positive impact on their payments in CY
2010. We do not believe there would be
any significant impact on beneficiaries,
as a result of the provisions of this rule.
Areas where negative impacts have been
estimated for HHAs, are primarily
urban, and thus we believe that
beneficiaries have a reasonable pool of
HHAs from which to receive home
health services.
TABLE 9—SMALL AGENCY IMPACTS
Comparison of 2009–2010 Changes
Group
Overall
(percent)
< 20
episodes
(percent)
20–49
episodes
(percent)
50–99
episodes
(percent)
100–199
episodes
(percent)
200 or
more
episodes
(percent)
Facility Location: Region of the Country
North ............................................................................................
South ............................................................................................
Midwest ........................................................................................
West .............................................................................................
Outlying ........................................................................................
3.79
¥4.01
3.67
¥1.52
4.46
0.20
¥21.93
2.63
¥5.67
4.48
3.05
¥17.44
3.45
¥10.21
4.41
3.06
¥14.71
3.52
¥9.16
4.86
3.70
¥3.67
3.79
¥3.78
4.40
3.83
1.29
3.75
1.98
4.44
TOTAL ..................................................................................
¥0.86
¥15.93
¥11.62
¥9.04
¥1.77
2.44
Facility Location: Region of the Country (Census Region)
4.88
3.19
¥11.68
3.72
0.41
3.62
3.85
2.09
¥2.90
4.46
¥3.21
3.94
¥53.28
4.11
¥5.64
2.45
4.05
1.59
¥11.37
4.48
3.53
2.59
¥45.86
2.30
¥2.55
3.21
4.69
¥1.38
¥16.68
4.41
4.79
1.42
¥40.50
3.90
¥1.26
3.61
3.17
1.52
¥13.11
4.86
4.05
3.30
¥16.47
3.24
1.67
3.88
3.46
1.80
¥6.55
4.40
5.04
3.21
¥0.59
3.79
2.27
3.69
3.99
2.99
1.65
4.44
TOTAL ..................................................................................
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
New England ................................................................................
Mid Atlantic ..................................................................................
South Atlantic ...............................................................................
East South Central .......................................................................
West South Central ......................................................................
East North Central .......................................................................
West North Central ......................................................................
Mountain ......................................................................................
Pacific ...........................................................................................
Outlying ........................................................................................
¥0.86
¥15.93
¥11.62
¥9.04
¥1.77
2.44
..................
¥11.62
..................
..................
..................
..................
..................
¥9.04
..................
..................
..................
..................
..................
¥1.77
..................
..................
..................
..................
..................
2.44
Facility Size (Number of First Episodes)
< 19 episodes ..............................................................................
20 to 49 ........................................................................................
50 to 99 ........................................................................................
100 to 199 ....................................................................................
200 or More ..........................................................................
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¥11.62
¥9.04
¥1.77
2.44
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..................
..................
..................
..................
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Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules
TABLE 9—SMALL AGENCY IMPACTS—Continued
Comparison of 2009–2010 Changes
Group
Overall
(percent)
< 20
episodes
(percent)
¥0.86
TOTAL ..................................................................................
20–49
episodes
(percent)
¥15.93
¥11.62
50–99
episodes
(percent)
¥9.04
100–199
episodes
(percent)
200 or
more
episodes
(percent)
¥1.77
2.44
REGION KEY:
New England = Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont;
Middle Atlantic = Pennsylvania, New Jersey, New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia, Maryland, North
Carolina, South Carolina, Virginia, West Virginia; East North Central = Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Tennessee; West North Central = Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota;
West South Central = Arkansas, Louisiana, Oklahoma, Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah,
Wyoming; Pacific = Alaska, California, Hawaii, Oregon, Washington; Outlying = Guam, Puerto Rico, Virgin Islands.
C. Accounting Statement and Table
Whenever a rule is considered a
significant rule under Executive Order
12866, we are required to develop an
Accounting Statement showing the
classification of the expenditures
associated with the provisions of this
proposed rule.
Table 10, below provides our best
estimate of the decrease in Medicare
payments under the HH PPS as a result
of the changes presented in this
proposed rule based on the best
available data. The expenditures are
classified as a transfer to the Federal
Government of $100 million dollars.
third year of a 4-year phase-in) to the
national standardized 60-day episode
rates and the NRS conversion factor to
account for the case-mix change
adjustment under the HH PPS. This
analysis above, together with the
remainder of this preamble, provides a
Regulatory Impact Analysis.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and budget.
List of Subjects
42 CFR Part 409
Health facilities, Medicare.
42 CFR Part 424
TABLE 10—ACCOUNTING STATEMENT:
CLASSIFICATION OF ESTIMATED EXPENDITURES, FROM THE 2009 HH
PPS CALENDAR YEAR TO THE 2010
HH PPS CALENDAR YEAR
Category
Transfers
Annualized Monetized
Transfers.
Negative transfer—
Estimated decrease
in expenditures:
$100 million.
Federal Government
to HH Providers.
From Whom To
Whom.
jlentini on DSKJ8SOYB1PROD with PROPOSALS2
D. Conclusion
In conclusion, we estimate that the
net impact of the proposals in this rule,
including a 2.75 percent reduction to
the national standardized 60-day
episode rates and the NRS conversion
factor to account for the case-mix
change adjustment, is approximately
$100 million in CY 2010 savings. The
$100 million impact reflects the
distributional effects of an updated
wage index (¥$10 million) as well as
the 2.2 percent home health market
basket increase (an additional $390
million in CY 2010 expenditures
attributable only to the CY 2010 home
health market basket), and the 2.75
percent decrease (¥$480 million for the
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Emergency medical services, Health
facilities, Health professions, Medicare,
Reporting and recordkeeping
requirements.
42 CFR Part 484
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 489
Health facilities, Medicare, Reporting
and recordkeeping requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR chapter IV as set forth below:
PART 409—HOSPITAL INSURANCE
BENEFITS
1. The authority citation for part 409
continues to read as follows:
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
2. Section 409.42 is amended as
follows:
A. Revising paragraph (c)(1).
B. Adding paragraph (c)(1)(i) and
(c)(1)(ii)
The revisions and additions read as
follows:
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§ 409.42 Beneficiary qualifications for
coverage of services.
*
*
*
*
*
(c) * * *
(1) Intermittent skilled nursing
services that meet the criteria for skilled
services and the need for skilled
services found in § 409.32. (Also see
§ 409.33(a) and (b) for a description of
examples of skilled nursing and
rehabilitation services.) These criteria
are subject to the following limitations
in the home health setting:
(i) In the home health setting,
management and evaluation of a patient
care plan is considered a reasonable and
necessary skilled service only when
underlying conditions or complications
are such that only a registered nurse can
ensure that essential non-skilled care is
achieving its purpose. To be considered
a skilled service, the complexity of the
necessary unskilled services that are a
necessary part of the medical treatment
must require the involvement of
licensed nurses to promote the patient’s
recovery and medical safety in view of
the overall condition. Where nursing
visits are not needed to observe and
assess the effects of the non-skilled
services being provided to treat the
illness or injury, skilled nursing care
would not be considered reasonable and
necessary, and the management and
evaluation of the care plan would not be
considered a skilled service. In some
cases, the condition of the patient may
cause a service that would originally be
considered unskilled to be considered a
skilled nursing service. This would
occur when the patient’s underlying
condition or complication requires that
only a registered nurse can ensure that
essential non-skilled care is achieving
its purpose. The registered nurse is
ensuring that service is safely and
effectively performed. However, a
service is not considered a skilled
nursing service merely because it is
performed by or under the supervision
of a licensed nurse. Where a service can
be safely and effectively performed (or
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self administered) by non-licensed staff
without the direct supervision of a
nurse, the service cannot be regarded as
a skilled service even if a nurse actually
provides the service.
(ii) In the home health setting, skilled
education services are no longer needed
if it becomes apparent, after a
reasonable period of time, that the
patient, family, or caregiver could not or
would not be trained. Further teaching
and training would cease to be
reasonable and necessary in this case,
and would cease to be considered a
skilled service. Notwithstanding that the
teaching or training was unsuccessful,
the services for teaching and training
would be considered to be reasonable
and necessary prior to the point that it
became apparent that the teaching or
training was unsuccessful, as long as
such services were appropriate to the
patient’s illness, functional loss, or
injury.
*
*
*
*
*
3. Section 409.43 is amended by
revising paragraph (e)(1)(ii) to read as
follows:
§ 409.43
Plan of care requirements.
*
*
*
*
*
(e) * * *
(1) * * *
(ii) Significant change in condition; or
*
*
*
*
*
4. Section 409.44 is amended by
revising the introductory paragraph of
(b)(1) to read as follows:
§ 409.44
Skilled services requirements.
*
*
*
*
*
(b) * * *
(1) Skilled nursing care consists of
those services that must, under State
law, be performed by a registered nurse,
or practical (vocational) nurse, as
defined in § 484.4 of this chapter, meet
the criteria for skilled nursing services
specified in § 409.32, and meet the
qualifications for coverage of skilled
services specified in § 409.42(c). See
§ 409.33(a) and (b) for a description of
skilled nursing services and examples of
them.
*
*
*
*
*
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PART 424—CONDITIONS FOR
MEDICARE PAYMENT
5. The authority citation for part 424
continues to read as follows:
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
6. Section 424.22 is amended as
follows:
A. Revising paragraph (a)(1)(i);
B. Revising paragraph (b)(2).
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§ 424.22 Requirements for home health
services.
(a) * * *
(1) * * *
(i) The individual needs or needed
intermittent skilled nursing care, or
physical or speech therapy, or (for the
period from July through November 30,
1981) occupational therapy. If a
patient’s underlying condition or
complication requires a registered nurse
to ensure that essential non-skilled care
is achieving its purpose, and
necessitates a registered nurse be
involved in the development,
management, and evaluation of a
patient’s care plan, the physician will
include a written narrative describing
the clinical justification of this need.
*
*
*
*
*
(b) * * *
(2) Content and basis of
recertification. The recertification
statement must indicate the continuing
need for services and estimate how
much longer the services will be
required. Need for occupational therapy
may be the basis for continuing services
that were initiated because the
individual needed skilled nursing care
or physical therapy or speech therapy.
If a patient’s underlying condition or
complication requires a registered nurse
to ensure that essential non-skilled care
is achieving its purpose, and
necessitates a registered nurse be
involved in the development,
management, and evaluation of a
patient’s care plan, the physician will
include a written narrative describing
the clinical justification of this need.
*
*
*
*
*
7. Section 424.530 is amended by
adding paragraph (a)(8) to read as
follows:
§ 424.530 Denial of enrollment in the
Medicare program.
(a) * * *
(8) A prospective HHA is determined,
under 42 CFR § 489.19, to be sharing,
leasing, or subleasing its practice
location or base of operations identified
in Section 4 of its Medicare provider
enrollment application with or to
another Medicare-enrolled HHA or
supplier.
*
*
*
*
*
8. Section 424.535 is amended by
adding paragraph (a)(11) to read as
follows:
§ 424.535 Revocation of enrollment and
billing privileges in the Medicare program.
(a) * * *
(11) An HHA is determined, under 42
CFR § 489.19, to be sharing, leasing, or
subleasing its practice location or base
of operations identified in Section 4 of
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39469
its Medicare provider enrollment
application with or to another Medicareenrolled HHA or supplier.
*
*
*
*
*
9. Section 424.540 is amended by
revising paragraph (b)(3) to read as
follows:
§ 424.540 Deactivation of Medicare billing
privileges.
*
*
*
*
*
(b) * * *
(3) With the exception of home health
agencies, reactivation of Medicare
billing privileges does not require a new
certification of the provider or supplier
by the State survey agency or the
establishment of a new provider
agreement.
(i) An HHA whose Medicare billing
privileges are deactivated under the
provisions found at 42 CFR 424.540(a)
must obtain an initial State survey or
accreditation by an approved
accreditation organization before its
Medicare billing privileges can be
reactivated.
(ii) [Reserved]
*
*
*
*
*
10. Section 424.550 is amended by
adding paragraphs (b)(1) and (2) to read
as follows:
§ 424.550 Prohibitions on the sale or
transfer of billing privileges.
*
*
*
*
*
(b) * * *
(1) If an owner of a home health
agency sells (including asset sales or
stock transfers), transfers or relinquishes
ownership of the HHA within 36
months after the effective date of the
HHA’s enrollment in Medicare, the
provider agreement and Medicare
billing privileges do not convey to the
new owner. The prospective provider/
owner of the HHA must instead:
(i) Enroll in the Medicare program as
a new HHA under the provisions of
§ 424.510, and
(ii) Obtain a State survey or an
accreditation from an approved
accreditation organization.
(2) [Reserved]
*
*
*
*
*
PART 484—HOME HEALTH SERVICES
11. The authority citation for part 484
continues to read as follows:
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C.1302 and
1395(hh)).
Subpart C—Furnishing of Services
12. Section 484.55 is amended by
revising paragraph (d)(1)(ii) to read as
follows:
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§ 484.55 Condition of participation:
Comprehensive assessment of patients.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) Significant change in condition; or
*
*
*
*
*
and (d)(1) in order for CMS to
administer the payment rate
methodologies described in §§ 484.215,
484.230, and 484.235.
PART 489—PROVIDER AGREEMENTS
AND SUPPLIER APPROVAL
Subpart E—Prospective Payment
System for Home Health Agencies
15. The authority citation for part 489
continues to read as follows:
13. Section 484.210 is amended by
revising paragraph (e) to read as follows:
Authority: Secs. 1102, 1819, 1820(e), 1861,
1864(m), 1866, 1869, and 1871 of the Social
Security Act (42 U.S.C. 1302, 1395i–3, 1395x,
1395aa(m), 1395cc, 1395ff, and 1395hh).
§ 484.210 Data used for the calculation of
the national prospective 60-day episode
payment.
*
*
*
*
*
(e) OASIS assessment data and other
data that account for the relative
resource utilization for different HHA
Medicare patient case-mix. An HHA
must submit to CMS the OASIS data
described at § 484.55(b)(1) and (d)(1) in
order for CMS to administer the
payment rate methodologies described
in §§ 484.215, 484.230 and 484.235.
14. Revising § 484.250 to read as
follows:
§ 484.250
Patient assessment data.
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OASIS data described at § 484.55(b)(1)
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16. Section 489.12 is amended by
adding paragraph (a)(5) to read as
follows:
§ 489.12
Decision to deny an agreement.
(a) * * *
(5) A prospective HHA is determined
to be sharing, leasing, or subleasing its
practice location or base of operations
identified in Section 4 of its Medicare
provider enrollment application with or
to another Medicare enrolled HHA or
supplier in violation of the HHA space
sharing prohibition set forth in § 489.19.
*
*
*
*
*
17. Adding a new § 489.19 to read as
follows:
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§ 489.19
Prohibition on space sharing.
An HHA is prohibited from engaging
in the following space sharing and/or
leasing arrangements:
(a) Sharing its practice location or
base of operations identified in Section
4 of its Medicare provider enrollment
application with another Medicareenrolled HHA or supplier; or
(b) Leasing or subleasing its practice
location or base of operations identified
in Section 4 of its Medicare provider
enrollment application to another
Medicare-enrolled HHA or supplier.
Authority: (Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: May 28, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: July 17, 2009.
Kathleen Sebelius,
Secretary.
Note: The following addenda will not be
published in the Code of Federal Regulations.
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[FR Doc. E9–18587 Filed 7–30–09; 4:15 pm]
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Agencies
[Federal Register Volume 74, Number 150 (Thursday, August 6, 2009)]
[Proposed Rules]
[Pages 39436-39496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18587]
[[Page 39435]]
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Part III
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 409, 424, 484, and 489
Medicare Program; Home Health Prospective Payment System Rate Update
for Calendar Year 2010; Proposed Rule
Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 /
Proposed Rules
[[Page 39436]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
42 CFR Parts 409, 424, 484, and 489
[CMS-1560-P]
RIN 0938-AP20
Medicare Program; Home Health Prospective Payment System Rate
Update for Calendar Year 2010
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule sets forth an update to the Home Health
Prospective Payment System (HH PPS) rates; the national standardized
60-day episode rates, the national per-visit rates, the non-routine
medical supply (NRS) conversion factor, and the low utilization payment
amount (LUPA) add-on payment amount, under the Medicare prospective
payment system for home health agencies effective January 1, 2010. In
addition, this rule proposes a change to the HH PPS outlier policy and
proposes to require the submission of OASIS data as a condition for
payment under the HH PPS. Also, this rule proposes payment safeguards
that would improve our enrollment process, improve the quality of care
that Medicare beneficiaries receive from HHAs, and reduce the Medicare
program's vulnerability to fraud. This rule also proposes clarifying
language to the ``skilled services'' section and Condition of
Participation (CoP) section of our regulations. This proposed rule also
clarifies the coverage of routine medical supplies under the HH PPS. We
are also soliciting comments on: Physician/patient interaction
associated with the home health plan of care (POC); a Consumer
Assessment of Healthcare Providers and Systems (CAHPS) Home Health Care
Survey; the Outcome and Assessment Information Set (OASIS), Version C,
effective January 1, 2010; proposed pay for reporting measures for use
in CY 2011; and a number of minor payment-related issues. We are also
responding to comments received as a result of our solicitation in the
CY 2008 HH PPS final rule with comment period.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 28,
2009.
ADDRESSES: In commenting, please refer to file code CMS-1560-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the instructions under
the ``More Search Options'' tab.
2. By regular mail. You may mail written comments to the following
address only: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1560-P, P.O. Box 8016,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1560-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A
stamp-in clock is available for persons wishing to retain a proof of
filing by stamping in and retaining an extra copy of the comments
being filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call (410) 786-7195 in advance to schedule your arrival with one
of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by following the
instructions at the end of the ``Collection of Information
Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
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phone 1-800-743-3951.
FOR FURTHER INFORMATION CONTACT:
Randy Throndset, (410) 786-0131 (overall HH PPS).
Sharon Ventura, (410) 786-1985 (for information related to payment
rates and wage indexes).
James Bossenmeyer, (410) 786-9317 (for information related to payment
safeguards).
Doug Brown, (410) 786-0028 (for quality issues).
Kathleen Walch, (410) 786-7970 (for skilled services requirements and
clinical issues).
Table of Contents
I. Background
A. Requirements of the Balanced Budget Act of 1997 for
Establishing the Prospective Payment System for Home Health Services
B. Deficit Reduction Act of 2005
C. System for Payment of Home Health Services
D. Updates to the HH PPS
II. Analysis of and Responses to Comments on the HH PPS Refinement
and Rate Update for CY 2008
III. Provisions of the Proposed Regulation
A. Outlier Policy
B. Case-Mix Measurement Analysis
C. Proposed CY 2010 Payment Rate Update
1. Home Health Market Basket Update
2. Home Health Care Quality Improvement
3. Home Health Wage Index
4. Proposed CY 2010 Payment Update
a. National Standardized 60-Day Episode Rate
[[Page 39437]]
b. Proposed Updated CY 2010 National Standardized 60-Day Episode
Payment Rate
c. Proposed National Per-Visit Rates Used To Pay LUPAs and
Compute Imputed Costs Used in Outlier Calculations
d. Proposed LUPA Add-On Payment Amount Update
e. Proposed Non-Routine Medical Supply Conversion Factor Update
D. OASIS Issues
1. HIPPS Code Reporting
2. OASIS Submission as a Condition for Payment
E. Qualifications for Coverage as They Relate to Skilled
Services Requirements
F. OASIS for Significant Change in Condition No Longer
Associated With Payment
G. Proposed Payment Safeguards for Home Health Agencies
H. Physician Certification and Recertification of the Home
Health Plan of Care
I. Routine Medical Supplies
IV. Collection of Information Requirements
A. ICRs Regarding the Requirements for Home Health Services
B. ICRs Regarding Deactivation of Medicare Billing Privileges
C. ICRs Regarding Prohibition Against Sale or Transfer of
Billing Privileges
D. ICRs Regarding Patient Assessment Data
V. Response to Comments
VI. Regulatory Impact Analysis
I. Background
A. Requirements of the Balanced Budget Act of 1997 for Establishing the
Prospective Payment System for Home Health Services
The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) enacted on
August 5, 1997, significantly changed the way Medicare pays for
Medicare home health services. Section 4603 of the BBA mandated the
development of the home health prospective payment system (HH PPS).
Until the implementation of a HH PPS on October 1, 2000, home health
agencies (HHAs) received payment under a cost-based reimbursement
system.
Section 4603(a) of the BBA mandated the development of a HH PPS for
all Medicare-covered home health services provided under a plan of care
(POC) that were paid on a reasonable cost basis by adding section 1895
of the Social Security Act (the Act), entitled ``Prospective Payment
For Home Health Services''. Section 1895(b)(1) of the Act requires the
Secretary to establish a HH PPS for all costs of home health services
paid under Medicare.
Section 1895(b)(3)(A) of the Act requires that: (1) The computation
of a standard prospective payment amount include all costs for home
health services covered and paid for on a reasonable cost basis and be
initially based on the most recent audited cost report data available
to the Secretary, and (2) the prospective payment amounts be
standardized to eliminate the effects of case-mix and wage levels among
HHAs.
Section 1895(b)(3)(B) of the Act addresses the annual update to the
standard prospective payment amounts by the home health applicable
percentage increase.
Section 1895(b)(4) of the Act governs the payment computation.
Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act require the
standard prospective payment amount to be adjusted for case-mix and
geographic differences in wage levels.
Section 1895(b)(4)(B) of the Act requires the establishment of an
appropriate case-mix change adjustment factor that adjusts for
significant variation in costs among different units of services.
Similarly, section 1895(b)(4)(C) of the Act requires the
establishment of wage adjustment factors that reflect the relative
level of wages, and wage-related costs applicable to home health
services furnished in a geographic area compared to the applicable
national average level. Pursuant to 1895(b)(4)(c), the wage-adjustment
factors used by the Secretary may be the factors used under section
1886(d)(3)(E) of the Act.
Section 1895(b)(5) of the Act gives the Secretary the option to
make additions or adjustments to the payment amount otherwise paid in
the case of outliers because of unusual variations in the type or
amount of medically necessary care. Total outlier payments in a given
fiscal year (FY) or year may not exceed 5 percent of total payments
projected or estimated.
In accordance with the statute, we published a final rule (65 FR
41128) in the Federal Register on July 3, 2000, to implement the HH PPS
legislation. The July 2000 final rule established requirements for the
new HH PPS for home health services as required by section 4603 of the
BBA, as subsequently amended by section 5101 of the Omnibus
Consolidated and Emergency Supplemental Appropriations Act (OCESAA) for
Fiscal Year 1999, (Pub. L. 105-277), enacted on October 21, 1998; and
by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP
Balanced Budget Refinement Act (BBRA) of 1999, (Pub. L. 106-113),
enacted on November 29, 1999. The requirements include the
implementation of a HH PPS for home health services, consolidated
billing requirements, and a number of other related changes. The HH PPS
described in that rule replaced the retrospective reasonable cost-based
system that was used by Medicare for the payment of home health
services under Part A and Part B. For a complete and full description
of the HH PPS as required by the BBA, see the July 2000 HH PPS final
rule (65 FR 41128 through 41214).
B. Deficit Reduction Act of 2005
On February 8, 2006, the Deficit Reduction Act of 2005 (Pub. L.
109-171) (DRA) was enacted. Section 5201 of the DRA requires HHAs to
submit data for purposes of measuring health care quality, and links
the quality data submission to payment. This requirement is applicable
for CY 2007 and each subsequent year. If an HHA does not submit quality
data, the home health market basket percentage increase will be reduced
2 percentage points. In accordance with the statute, we published a
final rule (71 FR 65884, 65935) in the Federal Register on November 9,
2006 to implement the pay-for-reporting requirement of the DRA,
codified at 42 CFR 484.225(h) and (i).
C. System for Payment of Home Health Services
Generally, Medicare makes payment under the HH PPS on the basis of
a national standardized 60-day episode payment rate that is adjusted
for the applicable case-mix and wage index. The national standardized
60-day episode rate includes the six home health disciplines (skilled
nursing, home health aide, physical therapy, speech-language pathology,
occupational therapy, and medical social services). Payment for non-
routine medical supplies (NRS), is no longer part of the national
standardized 60-day episode rate and is computed by multiplying the
relative weight for a particular NRS severity level by the NRS
conversion factor (See section III.C.4.e). Durable medical equipment
covered under the home health benefit is paid for outside the HH PPS
payment. To adjust for case-mix, the HH PPS uses a 153-category case-
mix classification to assign patients to a home health resource group
(HHRG). Clinical needs, functional status, and service utilization are
computed from responses to selected data elements in the OASIS
assessment instrument.
For episodes with four or fewer visits, Medicare pays on the basis
of a national per-visit rate by discipline; an episode consisting of
four or fewer visits within a 60-day period receives what is referred
to as a low utilization payment adjustment (LUPA). Medicare also
adjusts the national standardized 60-day episode payment rate for
certain intervening events that are subject to a
[[Page 39438]]
partial episode payment adjustment (PEP adjustment). For certain cases
that exceed a specific cost threshold, an outlier adjustment may also
be available.
D. Corrections
We published a final rule with comment period in the Federal
Register on August 29, 2007 (72 FR 49762) that set forth a refinement
and rate update to the 60-day national episode rates and the national
per-visit rates under the Medicare prospective payment system for home
health services for CY 2008. In this final rule with comment period, in
Table 10B (72 FR 49854), the short description for ICD-9-CM code 250.8x
& 707.10-707.9 should read ``PRIMARY DIAGNOSIS = 250.8x AND FIRST OTHER
DIAGNOSIS = 707.10-707.9''. Instead of a formal correction notice, we
are notifying the public of this correction in this proposed rule, and
subsequent final rule.
E. Updates to the HH PPS
As required by section 1895(b)(3)(B) of the Act, we have
historically updated the HH PPS rates annually in the Federal Register.
We published a notice in the Federal Register on November 3, 2008
(73 FR 65351) that set forth the update to the 60-day national episode
rates and the national per-visit rates under the Medicare prospective
payment system for home health services for CY 2009.
II. Analysis of and Responses to Comments on the HH PPS Refinement and
Rate Update for CY 2008
Our August 29, 2007 final rule with comment period set forth an
update to the 60-day national episode rates and the national per-visit
rates under the Medicare prospective payment system for HHAs for CY
2008. For that final rule, analysis performed on home health claims
data, from CY 2005, indicated a 12.78 percent increase in the observed
case-mix since 2000. The case-mix represented the variations in
conditions of the patient population served by the HHAs. We then
performed a more detailed analysis on the 12.78 percent increase in
case-mix to see if any portion of that increase was associated with a
real change in the actual clinical condition of home health patients.
CMS examined data on demographics, family support, pre-admission
location, clinical severity, and non-home health Part A Medicare
expenditure data to predict the average case mix weight for 2005. As a
result of that analysis, CMS recognized that an 11.75 percent increase
in case-mix was due to changes in coding practices and documentation
rather than to treatment of more resource-intensive patients.
To account for the changes in case-mix that were not related to an
underlying change in patient health status, CMS implemented a reduction
over 4 years in the national standardized 60-day episode payment rates
and the NRS conversion factor. That reduction was to be taken at 2.75
percent per year for three years beginning in CY 2008 and at 2.71
percent for the fourth year in CY 2011. CMS indicated that it would
continue to monitor for any further increase in case-mix that was not
related to a change in patient status, and would adjust the percentage
reductions and/or implement further case-mix change adjustments in the
future.
The CY 2008 HH PPS final rule with comment period specifically
solicited comments on the 2.71 percent reduction that is scheduled to
occur in 2011. In response, we received approximately 44 items of
correspondence from the public. Comments originated from trade
associations, HHAs, hospitals, and health care professionals such as
physicians, nurses, social workers, and physical and occupational
therapists. In the HH PPS Rate Update for CY 2009, we stated that we
would delay our responses to these comments until future rulemaking,
enabling us to respond more comprehensively as more current data became
available. The following discussion, arranged by subject area, includes
our responses to the comments.
A. Payment Reductions in the 4th Year (2011)
Comment: Commenters requested that CMS release the Abt technical
report so that the industry could review the data and information
within it. Without the Abt report, the commenters stated the industry
would be unable to offer meaningful comments on the case mix-
reductions.
Response: The Abt Technical Report was posted online and made
available to the public on April 30, 2008 at: https://www.cms.hhs.gov/Reports/downloads/Coleman_Final_April_2008.pdf. Although we posted
the report later than anticipated, we believe that the CY 2008 HH PPS
final rule with comment period adequately presented information,
documentation and evidence describing the Abt case-mix study and CMS'
rationale for the reductions. Accordingly, we believe we have provided
sufficient time and information to the public to fully review and
comment upon the rate reductions that will take effect in CY 2011.
Comment: A commenter suggested that the 4th year cut of 2.71
percent be eliminated or indefinitely deferred until better data are
available. Some commenters stated that an additional year of rate cuts
will place a financial burden on HHAs, and will result in limited
access to home care, especially in rural areas. These commenters
further state that limited access may result in more hospitalizations
and/or care being provided in more costly settings. Commenters also
stated that imposing a 4th year reduction on HHAs would be detrimental
and unduly harsh, as many HHAs are already struggling to meet the
rising costs of providing care, and that the reductions will cause HHAs
to operate at negative margins and likely close.
Several commenters suggested alternatives to CMS' approach to
adjusting for nominal case-mix. For example, one commenter suggested
spreading the total cuts across a 6-year period rather than a 4-year
period, enabling CMS to better monitor the impact of the CY 2008 HH PPS
refinements and CY 2008 and 2009 reductions prior to imposing
additional reductions.
Another commenter suggested that CMS withdraw its decision to
reduce the payment rates until CMS could design and implement a better
method to analyze changes in the case-mix, based on adjusted final
claims data that would utilize patient characteristics in the model, as
well as changes in per-patient annual expenditures, patient clinical,
functional, and service utilization data, and dynamic factors in the
Medicare system that impact on the nature of patients served with home
health care.
Response: Our continued analysis shows that Medicare nominal case-
mix continues to increase. Therefore, we continue to believe it
necessary to reduce rates through 2011 to counterbalance the Medicare
expenditure effects of this nominal increase. We also continue to
believe that phasing in the reductions over a four-year period provides
fair and ample time for HHAs to prepare for the reductions.
As more current data become available, we will continue to update
our case-mix analysis. As discussed in Section III.B. of this proposed
rule, based on analysis of data through 2007, nominal case-mix has
further increased. We now estimate that the nominal case-mix has grown
by an estimated 13.56 percent between FY 1999 (the Interim Payment
System (IPS) baseline period) and 2007, an additional 1.81 percentage
points above the previously recognized
[[Page 39439]]
increase. If we were to account for the entire 13.56 percent increase
in nominal case-mix in one year (taking into account that we have
already imposed 2.75 percentage reductions in CY 2008 and CY 2009), we
estimate that the percentage reduction in the national standardized 60-
day episode payment rates and the NRS conversion factor would be 6.89
percent in CY 2010. If we were to account for the entire 13.56 percent
increase in nominal case-mix over two years (taking into account that
we have already imposed 2.75 percentage reductions in CY 2008 and CY
2009), we estimate that the percentage reduction in the national
standardized 60-day episode payment rates and the NRS conversion factor
for each of the remaining two years (2010 and 2011) would be 3.51
percent per year. As discussed in Section II.C. of this proposed rule,
we currently plan to move forward with the CY 2010 reduction of 2.75
percent, as set forth in the CY 2008 final rule. However, we note that,
in light of, among other things, new policy developments, more recent
information, or changed circumstances from the time the CY 2008 rule
was published, the Secretary is also considering making additional
changes in the final rule to account for the residual increase in
nominal case-mix discussed above. In such an instance, we would
consider accounting for the residual increase in nominal case-mix in
one year in the final rule, which we estimate would result in a 6.89
percent reduction to the national standardized 60-day episode payment
rates and the NRS conversion factor for CY 2010. We are seeking
comments on the full range of potential nominal case-mix reduction
percentages.
With high projected HH margins and continued growth in the number
of new HH agencies, we do not believe that the 2.71 percent reduction
for 2011 will result in decreased access to home health care for
Medicare beneficiaries. The Medicare Payment Advisory Commission's
(MedPAC) March 2009 Annual Report states that the home health industry
margin for 2007 was 16.6 percent and projects that average margins for
2009, which considers the 2.75 reduction, will be 12.2 percent. MedPAC
also analyzed the average rate of HH cost growth and found that in most
years, the rate of actual cost growth in HHAs has been lower than the
rate of inflation indicated by the home health market basket. MedPAC
reports that payments for HHAs have exceeded costs for all of the
period under PPS by a wide margin.
Also, in their March 2009 report, MedPAC reports a 32 percent
growth in the number of HH agencies since 2003, stating that the supply
of agencies continues to increase faster than the growth in the overall
number of Medicare beneficiaries. We believe that new home health
providers continue to enter the home health industry because Medicare
payment levels give them adequate incentive to do so.
In response to commenters who suggested that we consider
alternative methods to identify nominal case-mix before we impose the
CY 2011 reductions, we continue to believe that the Abt model
adequately identifies nominal case-mix. As we described in our August
2007 final rule, our enhanced model included variables such as changes
in the age structure of the home health user population, changes in the
types of patients being admitted to home health, utilization of
Medicare Part A services in the 120 days leading up to home health, the
type of preadmission acute care stays when the patient last had such a
stay and variables describing living situations. Many of these model
enhancements addressed suggestions made by the industry in their
proposed rule comments.
B. General Case-mix Comments
Our August 29, 2007 final rule with comment period solicited
comments only on the 2.71 percent fourth year reduction (72 FR 49762).
Nevertheless, we received several comments unrelated to the fourth year
reduction. Because such comments (including comments on outliers, LUPAs
(Low Utilization Payment Adjustments), OASIS, wage index, operational
issues, diagnosis coding, HHRGs, and wound care payment) are out of the
scope of this rulemaking, we are not responding to these comments in
this proposed rule. However, we are responding to comments on case-mix
measurement methodology, as we believe such comments are tangentially
related to the reduction for CY 2011, and because we wish to fully
address this issue.
Comment: A commenter stated that the August 27, 2007 final rule
with comment period was not a ``logical outgrowth'' of the May 4, 2007
proposed rule. The commenter stated that CMS used a different
methodology for evaluating case-mix weight scores and changes in
patient characteristics than had been used in the proposed rule. The
commenter recommended that CMS engage in another cycle of rulemaking in
order to provide further opportunity to comment.
Response: The policy adopted in the August 2007 final rule was a
policy that adjusted payments in order to account for increases in
nominal case-mix. This policy was both proposed and finalized. The
commenter is addressing not the policy of adjusting payments for
nominal case-mix increases, but rather, how CMS implements this policy;
that is, the methodology CMS uses for determining the level of nominal
case-mix increase. While we do not believe we are required to subject
our exact, final calculations regarding the increase to public comment,
it is also important to note that our final methodology clearly was an
outgrowth of the proposed rule. The proposed rule included a detailed
analysis of various kinds of data, such as an extensive review of the
content of changes in OASIS instructions, a review of changes in the
frequencies of severity levels of the case-mix system, and a detailed
presentation of how OASIS items other than those used for case-mix
frequently changed little, if at all. We also discussed the pattern of
change in functional items, showing that for a number of items, some
changes occurred at the high-functioning end, while the worst-
functioning levels didn't increase in the population. There was a
similar analysis of wound item changes. Our interpretation of the
totality of the data was that real case-mix did not materially change
since the IPS baseline. We also identified a large increase in post-
surgical patients with their traditionally lower case-mix index.
However, we made an adjustment to our estimate of case-mix change to
account for the change in the composition of the home health industry
on account of the exit of some hospital-owned agencies. These details
enabled the home health industry to analyze our proposed methodology
and provide comments suggesting specific types of changes in patient
acuity that could help to explain identified changes in home health
case-mix. For the final rule, we enhanced our formal estimate of case-
mix change, which we had statistically adjusted to account for change
in the presence of hospital-owned agencies in the industry, with a
methodology that statistically adjusted for multiple factors, including
the types of factors mentioned by commenters. Application of this model
allowed us to simultaneously ``subtract'' from the growth in the
national case-mix index the effects of a multitude of factors besides
the change in hospital-owned agencies. Additionally, in the May 4, 2007
proposed rule (72 FR 25395) we indicated that our analysis for the
final rule would be updated to include 2005 data.
[[Page 39440]]
Specifically, for the final rule, we updated the case-mix index and
some of the statistical data (e.g., average resources per episode) to
include 2005 data. We also added analyses focusing on certain types of
patients, including those mentioned in public comments on the proposal
(e.g., knee replacement patients). Further, as just discussed in the
paragraph above, we added results from a multivariate model of case-mix
that isolated real case-mix change between the HH IPS baseline and
2005. The newly added data and the model responded to comments that
cited circumstances of particular types of patients and/or sought
additional types of evidence. These added data and analyses were made
in response to the proposed rule comments. The data and information
added for the final rule, along with the entire array of evidence we
presented in the proposed and the final rule are the bases for the
identification of nominal case-mix change.
Comment: Some commenters focused on the finding that only 8 percent
of the case-mix change from 2000 to 2005 was real. These commenters
recommended that CMS start with the assumption that all case-mix change
is real, and only consider the amount that could be estimated as
nominal to be unjustified.
Another commenter pointed to CMS' assertion that ``real'' case-mix
increased prior to implementation of the HH PPS (prior to September
2000) and argued that this fact demonstrates that it was unreasonable
for CMS to assume that none of the change after that point was real.
Commenters suggested that case-mix has increased due to several
factors, including earlier discharges from general acute hospitals, PPS
changes that provided incentives to treat higher-acuity patients, and
other post-acute care regulations issued by CMS (such as the inpatient
rehabilitation ``75% Rule''), which diverts more medically complex
patients to homecare. One commenter urged CMS to defer any adjustment
for case-mix change and to perform an analysis that accounted for these
factors.
Response: The predictive model isolated 8.03 percent of the overall
12.78 percent increase in case-mix as real, resulting in an 11.75
percent nominal increase in case-mix. We relied on those results to
arrive at the nominal case-mix reductions -2.75 percent for 3 years and
-2.71 percent for the fourth year of the phase-in. (Refer to Section
III.B. of this proposed rule for an update based on analysis of data
through 2007.) Thus, our model allowed and presumed some real case-mix
change. The model data relied on claims data instead of OASIS data
(with the exception of one variable, which described the patient's
living situation), to avoid reliance on data which we knew were subject
to coding changes such as those resulting from educational
improvements, changes in OASIS instructions, and financial incentives.
The model takes into account the total change between the baseline and
the follow-up year (2005) in the sources of patients (hospital,
inpatient rehabilitation facility, and skilled nursing facility). It
also takes into account total change in the types of acute hospital
problems and hospital-recorded comorbidities experienced by patients
before they entered home health care, total change in living situation,
and total change in patients' Part A expenditures incurred in the 120
days leading up to the beginning of each episode (expenditures were
adjusted for price increases). Length of stay is also accounted for by
summing the number of inpatient days of various types. Additionally, we
added analyses focusing on certain types of patients, including those
mentioned in public comments on the proposal (e.g., knee replacement
patients).
Every predictive model has its limitations; however, we believe the
model and data we used were the best available for the purposes of
measuring case-mix in an unbiased manner. For example, we relied on
hospital claims data instead of OASIS data (with the exception of one
OASIS variable), and enhanced our calculation method to include a
multivariate approach to case-mix measurement. For those patients who
were hospitalized before home care, the model included whether the
hospitalization was surgical or medical, and in many cases the model
identified the particular, detailed conditions that were responsible
for that hospital stay. These additions to the model were suggested by
the industry in comments on the proposed rule.
Moreover, we again note that the Abt model was not the sole basis
for the final regulation provision on nominal case-mix change. The
basis for the final provision was the entire array of evidence we
presented in the proposed and the final rules. In addition, in the May
4, 2007, proposed rule (72 FR 25362-25366) we noted data as well as
commentary from observers indicating that therapy treatment plans were
sometimes ``padded'' to reach the ten-visit therapy threshold; we
consider this behavior a component of nominal case-mix change, because
therapy visits help to determine the case-mix group.
In response to the comment that CMS should have started with the
assumption that all case-mix growth was real, and then calculate what
portion, if any, was nominal, the model did assess real case-mix using
a variety of Part A claims. We then compared the model's prediction of
real case-mix with the actual billed case-mix, determining the
calculated difference to be nominal. The May 4, 2007, proposed rule put
the case-mix of the Medicare home health population in historical
perspective. It described the changes affecting the home health benefit
since the Balanced Budget Act of 1997 and cited MedPAC, GAO and other
literature findings that the HH IPS had a strong impact on the types of
patients served. We compared the case-mix index from the Abt Associates
study sample with the case-mix index of the HH IPS baseline (1999-
2000), a comparison that suggested that changes in real case-mix did
occur as a result of the HH IPS. Literature findings (GAO, ``Medicare
Home Health Benefit: Impact of Interim Payment System and Agency
Closures on Access to Services,'' September 1998, GAO/HEHS-98-238)
describe an HH IPS incentive to admit many different patients with
short-term or rehabilitation needs instead of lengthy low skilled care
needs. We did not rule out that some of the change during that period
was nominal, in part because the HH PPS proposed rule of 1999 probably
affected provider behavior.
Moreover, our analysis of changes in resource use showed that
resource use stayed below the resource use level of the HH IPS period
for much of the succeeding five years, casting doubt on the commenters'
assertion that patient acuity increased. Specifically, after the IPS
was implemented, we saw a decline in visit use from 73 visits per
person in 1997 to 42 visits per person in 1999. The number of visits
further decreased under the HH PPS, decreasing to 37 in 2000, and 31
for each year 2001 through 2004.
Comment: A commenter believes that CMS's decision to implement
these payment reductions is unjustified and flawed for two basic
reasons: (1) There have been actual changes in the home health
population; and (2) providers have improved the accuracy of OASIS
coding. The commenter refers to recently released data by Outcome
Concept Systems citing the average 2005 adjusted case-mix weight
nationally and in New York was approximately 1.15, not 1.2361, as CMS
asserts.
The commenter believes that the average case-mix weight has changed
because CMS fails to consider therapy as a patient characteristic and
because patients' clinical severity has increased. Furthermore, the
commenter believes
[[Page 39441]]
that the increase in patients' clinical needs is largely due to an
inpatient hospital payment system that has created incentives for early
discharge of patients who require more care. The result is a home
health population with higher acuity and more intense resource needs.
The commenter also states that growth in Medicare Advantage plans has
shifted lower acuity patients out of traditional Medicare, leaving
higher need and higher cost beneficiaries within the traditional
Medicare program.
A commenter stated that current OASIS data show that HHAs are
admitting increased numbers of beneficiaries with: (1) Comorbidities
such as diabetes and obesity; (2) abnormalities of gait; (3) wound
infections; (4) urinary incontinence; and (5) increased cognitive
function deficits. The accumulative effect of these admissions has
necessitated increased therapy services which have resulted in higher
clinical and functional scores in case-mix weights. In addition, the
commenter believes that physical therapy services were underutilized
during the HH IPS and at the onset of the HH PPS because of lack of
clinical knowledge and understanding of best practice standards. The
delivery of medical services in the home has improved over recent
years. This is evident by implementation of quality measures and
outcomes data. Several commenters believe that the increase in average
case-mix can be attributed fully to an improvement in each agency's
ability to correctly answer OASIS items and increased emphasis on OASIS
validity by Quality Improvement Organizations (QIO). Another commenter
stated that their agency has experienced a change in the percentage of
orthopedic patients due to changes in regulations for rehabilitation
hospitals.
Response: In the May 4, 2007 HH PPS proposed rule, we indicated
that the analysis of national case-mix would be updated using 2005 data
in that year's HH PPS final rule, and that the annual adjustments for
nominal case-mix change would be modified accordingly.
As we have noted elsewhere, improvements in coding do not represent
real case-mix changes, which means that the Medicare program arguably
may have overpaid for some of the services which were provided after
improvements in OASIS coding were implemented. CMS subsequently
adjusted the standardized payment amount to compensate for the nominal
change in case-mix used to pay claims in the years following the
introduction of the PPS.
We acknowledge that therapy treatment services were used as a case-
mix characteristic in the case-mix model, in the absence of sufficient
explanatory power from OASIS data items to model resource use by
themselves. However, we found a dramatic change in the distribution of
episodes according to the number of therapy visits between the HH IPS
baseline period and the early years of the HH PPS period, and the new
distribution has persisted. We continue to believe that the change in
this short period is an indication of behavioral change on the part of
home health agencies, and is not necessarily related to real case-mix
change. Moreover, the distributional shift occurred in the absence of
convincing evidence from various OASIS items that patients were
actually more impaired and sickly. Furthermore, when we took account of
patient characteristics in the model of real case-mix change, the
results did not support a large difference in patient acuity.
We also note that the reporting of more comorbidities by HHAs is
not clear evidence of change in patient status, as it could be a result
of improvements in coding training alone. In addition, changes in
regulations affecting rehabilitation hospitals are represented in the
case-mix change model by the variables that measure the source of
admission.
To the extent that the home health industry has accomplished
improvements in patient function without adding significant resources
to the provision of care in home health episodes, we understand this is
likely attributable to shifts in the service mix provided within the
episode, as well as improved care practices. Again, however, the
situation does not necessarily indicate a real change in case-mix.
Without more detailed information about their analysis, we are
unable to comment on the implication in the statistic from Outcome
Concept Systems in New York State (as reported by the commenter) that
the average case-mix rose only 1.15 as compared to 1.2361 in CMS's
analysis. The average case-mix is computed from an extremely large
representative sample of national home health claims data. The
commenter does not provide information about the method of adjustment,
the conditions of data-gathering, or the quality or source of the data
sources used by Outcome Concept Systems.
Comment: A commenter stated that CMS' review of 20 percent of
claims (OASIS for 2004-2005) does not reflect the patient
characteristics in 2007, and it certainly does not reflect those
receiving services in 2010 and 2011.
Response: We based our proposals on the latest statistically
representative data available, and those data were from 2005 at the
time of the preparation of the final regulation. We will continue to
update the data as they become available.
Comment: A commenter stated that CMS should look more closely at
specific agencies it suspects may be upcoding and then seek financial
restitution from those that are ultimately deemed to be following this
practice. Across-the-board cuts of this magnitude are unwarranted at a
time when the home health industry should be receiving additional
support to serve an expanding older population.
Response: As we stated in the CY 2008 HH PPS final rule (72 FR at
49837), we believe that it is more appropriate to implement a
nationwide approach to the issue of a case-mix change adjustment. An
individual agency approach would be administratively burdensome and
difficult to implement. Policies to address the identity of agencies in
light of changes to organizational structures and configurations would
need to be developed. Furthermore, smaller agencies might have
difficulty in providing accurate measures of real case-mix changes
because of their small caseloads. Because the nominal increase in case-
mix grew significantly from 2003 to 2005 (8.7 percent to 11.75
percent), we spread out the schedule of adjustments from 3 years to 4
years in order to ameliorate the impact that would have been felt by
HHAs had we decided to account for the entire 11.75 percent increase in
case-mix over 3 years.
Comment: A commenter is concerned that CMS has not correctly
addressed factors measuring the apparent ``creep''. Additionally, the
commenter states that it was useful to have CMS clarify that they had
excluded LUPAs from the two measurement bases utilized and that fact
raises an issue that CMS did not address in the rule. When the original
HH PPS was proposed (October 1999) and finalized (July 2000), CMS
asserted that it expected LUPA incidence, as estimated by its
actuaries, would be five percent. Actual incidence has, since
implementation, averaged sixteen percent of total reimbursements. Using
just a five percent rate of occurrence resulted in every original HHRG
assigned a lower value than if CMS had used, say, a fifteen percent
rate of incidence. Accordingly, the commenter argues that home health
agencies were
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under-compensated by approximately 11 percent for LUPA savings.
Response: While this comment is outside the scope of the topic (the
4th year reductions) which we solicited comments on, we will briefly
respond. In the July 2000 final rule (65 FR 41162), we stated that the
estimate of the percentage of LUPA episodes was an actuarial estimate,
as were the estimates of incidence of SCICs, PEPs, and outliers. Our
base episode payment rates are derived using the best data available at
that time. The commenter is correct that the actual number of LUPA
episodes is higher than our original estimate. However, while it is
true that 16 percent of episodes from the 1998 pre-PPS data analysis
were shown to be LUPA-type episodes (65 FR 41186), we also provided
reasoning in that discussion as to why we believed actual LUPA
incidence under the HH PPS would be lower. Granted, the incidence of
LUPAs did not drop to the level of 5 percent of the total number of
episodes as was originally estimated, however the average actual
incidence of LUPAs is, and has always been considerably lower than the
16 percent suggested by the commenter. In fact, data analysis shows us
that the incidence of LUPA episodes was first measured at approximately
15.2 percent of the total number of episodes and has continued to
decrease under the HH PPS. Specifically, recent analysis of home health
claims shows that LUPA episodes made up approximately 10.6 percent of
the total number HH PPS episodes in CY 2007.
Another important fact that should not be lost, as part of this
discussion, is that while the incidence of LUPAs is less than
originally estimated, we note that the average number of home health
visits provided per episode for non-LUPAs episodes is also lower than
what we originally estimated (65 FR 41171) when we built the base
payment rates (21.16 vs 25.5 home health visits). Hence, the national
standardized 60-day episode payment is currently based on the delivery
of significantly more home health visits per episode (25.5) than is
currently being delivered (21.16).
It is also worth noting that the manner in which the commenter
appears to arrive at their under-compensation of payment percentage is
by subtracting the original estimate for LUPA episodes of 5 percent
from their inaccurate estimate of 16 percent incidence of LUPA
episodes. In addition to the commenters 16 percent being inaccurate (as
mentioned above), it is important to point out that even in doing the
math, an inaccurate 16 percent minus 5 percent actually reflects that
there is an 11 percentage point difference between the two, not an 11
percent under-compensation in payment as the commenter suggests.
Because the incidence of LUPAs is considerably lower than the 16
percent that the commenter suggests, and the average number of home
health visits per episode is far less than originally estimated, HHAs
have not been under-compensated by 11 percent, as the commenter
suggests.
Since the inception of the HH PPS, we have monitored home health
utilization in preparing the refinements to the HH PPS. We have always
contended that it would not be appropriate to address single aspects of
the system, as the many pieces/aspects of the system interact and there
are causes and effects that each has on one another. Consequently, we
have addressed those issues for which we believed we had adequate
information, as a result of our analysis in the CY 2008 HH PPS proposed
and final rules. In doing so, as is generally done in a prospective
payment system, we decided not to make retroactive adjustments for
actual utilization that differed from estimates.
III. Provisions of the Proposed Rule
A. Outlier Policy
1. Background
Section 1895(b)(5) of the Act allows for the provision of an
addition or adjustment to the regular 60-day case-mix and wage-adjusted
episode payment amount in the case of episodes that incur unusually
high costs due to patient home health care needs. This section further
stipulates that total outlier payments in a given year may not exceed 5
percent of total projected or estimated HH PPS payments. Section
1895(b)(3)(C) of the Act stipulates that the standard episode payment
be reduced by such a proportion to account for the aggregate increase
in payments resulting from outlier payments.
In the July 2000 final rule (65 FR 41189), we described and
subsequently implemented an HH PPS outlier policy under which we reduce
the standard episode payment by 5 percent, and target up to 5 percent
of total projected estimated HH PPS payments to be paid as outlier
payments. The July 2000 final rule described a methodology for
determining outlier payments. Under this system, outlier payments are
made for episodes whose estimated cost exceeds a threshold amount. The
episode's estimated cost is the sum of the national wage-adjusted per-
visit rate amounts for all visits delivered during the episode. The
outlier threshold is defined as the national standardized 60-day
episode payment rate for that case-mix group plus a fixed dollar loss
(FDL) amount. Both components of the outlier threshold are wage-
adjusted. The wage-adjusted FDL amount represents the amount of loss
that an agency must experience before an episode becomes eligible for
outlier payments. The wage-adjusted FDL amount is computed by
multiplying the national standardized 60-day episode payment amount by
the FDL ratio, and wage-adjusting that amount. That wage-adjusted FDL
amount is added to the HH PPS payment amount to arrive at the wage-
adjusted outlier threshold amount. The outlier payment is defined to be
a proportion of the wage-adjusted estimated costs beyond the wage-
adjusted outlier threshold amount. The proportion of additional costs
paid as outlier payments is referred to as the loss-sharing ratio. The
FDL ratio and the loss-sharing ratio were selected so that the
estimated total outlier payments would not exceed the 5 percent level.
We chose a value of 0.80 for the loss-sharing ratio, which is
relatively high, but preserves incentives for agencies to attempt to
provide care efficiently for outlier cases. A loss-sharing ratio of
0.80 means that Medicare pays 80 percent of the additional costs above
the wage-adjusted outlier threshold amount. A loss-sharing ratio of
0.80 is also consistent with the loss-sharing ratios used in other
Medicare PPS outlier policies, such as inpatient hospital, inpatient
rehabilitation, long-term hospital, and inpatient psychiatric payment
systems. In CY 2000, we estimated that a FDL ratio of 1.13 would yield
estimated total outlier payments that were projected to be no more than
5 percent of total HH PPS payments. As discussed in the October 1999
proposed rule (64 FR 58169) and the July 2000 final rule (65 FR 41189),
the percentage constraint on total outlier payments creates a tradeoff
between the values selected for the FDL amount and the loss-sharing
ratio. For a given level of outlier payments, a higher fixed dollar
loss amount reduces the number of cases that receive outlier payments,
but makes it possible to select a higher loss-sharing ratio and
therefore increase outlier payments per episode. Alternatively, a lower
fixed dollar loss amount means that more episodes qualify for outlier
payments but outlier payments per episode must be lower. Therefore,
setting these two parameters involves policy choices about the number
of outlier cases and their rate of payment.
When the data became available, we performed an analysis of CY 2001
home
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health claims data. This analysis revealed that outlier episodes
represented approximately 3 percent of total episodes and 3 percent of
total HH PPS payments. Additionally, we performed the same analysis on
CY 2002 and CY 2003 home health claims data and found the number of
outlier episodes and payments held at approximately 3 percent of total
episodes and total HH PPS payments, respectively. Based on these
analyses and comments we received, we decided that an update to the FDL
ratio would be appropriate.
To that end, for the October 22, 2004 HH PPS rate update for the CY
2005 final rule, we performed data analysis on CY 2003 HH PPS claims
data. The results of that analysis indicated that a FDL ratio of 0.70
was consistent with the existing loss-sharing ratio of 0.80 and a
projected target percentage of estimated outlier payments of no more
than 5 percent. Consequently, we updated the FDL ratio from the initial
ratio of 1.13 to an FDL ratio of 0.70. Our analysis showed that
reducing the FDL ratio from 1.13 to 0.70 would increase the percentage
of episodes that qualified for outlier episodes from 3.0 percent to
approximately 5.9 percent. A FDL ratio of 0.70 also better met the
estimated 5 percent target of outlier payments to total HH PPS
payments. We believed that this updated FDL ratio of 0.70 preserved a
reasonable degree of cost sharing, while allowing a greater number of
episodes to qualify for outlier payments.
Our CY 2006 update to the HH PPS rates (70 FR 68132) updated the
FDL ratio from 0.70 to 0.65 to allow even more home health episodes to
qualify for outlier payments and to better meet the estimated 5 percent
target of outlier payments to total HH PPS payments. For the CY 2006
update, we used CY 2004 home health claims data.
In our CY 2007 update to the HH PPS rates (71 FR 65884) we again
updated the FDL ratio from 0.65 to 0.67 to better meet the estimated 5
percent target of outlier payments to total HH PPS payments. For the CY
2007 update, we used CY 2005 home health claims data.
In the CY 2008 final rule with comment period, in the interest of
using the latest data and best analysis available, we performed
supplemental analysis on the most recent data available in order to
best estimate the FDL ratio. That analysis derived a final FDL ratio of
0.89 for CY 2008.
In order to determine the appropriate value for the FDL ratio for
the CY 2009 rate update, in the November 3, 2008 HH PPS Rate Update for
CY 2009 notice (73 FR 65351), we performed an analysis using the most
recent, complete available data at the time (CY 2006), applying a
methodology similar to that which we used to update the FDL ratio in
the CY 2008 HH PPS final rule. That updated analysis projected that in
CY 2009 we would expend an estimated 10.26 percent of total estimated
HH PPS payments in outlier payments, more than twice our 5 percent
statutory limit. Our analysis also revealed that this growth in outlier
payments was primarily the result of excessive growth in outlier
payments in a few discrete areas of the country. We noticed statistical
anomalies in outlier payments in terms of both high outlier dollars and
as a percentage of total HH PPS payments, in areas such as Miami-Dade
Florida, where outlier payments to providers far exceed the national
average and the 5 percent target for outlier payments. Using similar
analysis to what was performed for the CY 2008 final rule with comment,
we estimated that we would need to raise our FDL ratio from 0.89 to
2.71 for CY 2009 in order for estimated outlier payments to be no more
than 5 percent of total HH PPS payments. In addition, the size of these
statistical anomalies raised concerns about the medical necessity of
the outlier episodes in some areas. However, in our CY 2009 payment
update, we did not raise the FDL ratio to 2.71, given the statistical
outlier data anomalies that we identified in certain targeted areas,
because program integrity efforts, such as payment suspensions for
suspect HHAs, were underway to address excessive, suspect outlier
payments that were occurring in these areas. Instead, we maintained the
then-current (CY 2008) FDL ratio of 0.89 in CY 2009 while actions to
remedy any inappropriate outlier payments in these target areas of the
country were effectuated.
2. Proposed Change to Target Outlier Payment Percentage
For CY 2010 rulemaking, we have expanded our outlier analysis. In
addition to assessing what FDL ratio would most accurately achieve the
5 percent target of outlier payments as a percentage of total HH PPS
payments, we also performed analyses to assess the appropriateness of
adopting a lower target percentage of outlier payments to total HH PPS
payments. Some commenters to our CY 2008 proposed rule suggested that
CMS should consider targeting a lower percentage in outlier payments to
total estimated HH PPS payments.
Commenters suggested that by lowering the target outlier percentage
to total estimated HH payments, CMS could then return to the national
standardized 60-day episode payment rate, a portion of that 5 percent
which was originally withheld from the rates to fund the 5 percent of
total estimated HH PPS outlier payments. In our response to the CY 2008
comments, we described our concern that reducing the target outlier
percentage could risk access to home care for high needs patients.
However, recent analysis of more current data, specifically CY 2007 and
CY 2008 data, suggests that a target around that of 2.5 percent in
outlier payments to total estimated HH PPS payments may be a more
appropriate target than 5 percent, while not risking access to care for
high needs patients. Section 1895(b)(5) of the Act states that the
Secretary ``may'' provide for an addition or adjustment to the payment
amount otherwise made in the case of outliers. It goes on to say that
if the Secretary decides to provide such a payment, that the total
amount of the additional payments or payment adjustments may not exceed
5 percent of the total payment projected or estimated to be made under
the payment system. Consequently, providing an addition or adjustment
to the payment amount for outliers is optional and not statutorily
required. We performed an analysis of all providers who receive outlier
payments, focusing our analysis on total HH PPS payments, total outlier
payments, number of episodes, number of outlier episodes, and location
of provider. As discussed below under ``Proposed Outlier Cap Policy'',
our analysis incorporates a proposed 10 percent cap on outliers and
looks at outlier payments as a percentage of total HH PPS payments with
that 10 percent cap in place. In our analysis of 2007 data, after
implementing the 10 percent cap, outlier dollars accounted for
approximately 2.1 percent of total HH PPS payments.
Additionally, we performed a separate analysis on a major
association of home health agencies who claim to be safety-net
providers, serving sicker, more costly patients. The average outlier
payment to these agencies is also under 2 percent. Therefore, we
believe a target of less than 5 percent for outlier dollars as a
percentage of total estimated HH PPS payments is appropriate. However,
past years' data trends show us that outlier payments will likely
continue to grow. Consequently, we propose to change our target
percentage of outlier payments from 5 percent to approximately 2.5
percent of total estimated HH PPS payments.
Currently, we reduce the national standardized 60-day episode
payment
[[Page 39444]]
rates, the national per-visit rates, the LUPA add-on amount, and the
NRS conversion factor by 5 percent in order to create an outlier pool
that accommodates estimated outlier payments of 5 percent of total HH
PPS payments. Targeting the percentage of outlier payments at
approximately 2.5 percent will allow us to create a smaller outlier
pool and return the remaining 2.5 percent to the HH PPS rates. We would
retain a 2.5 percent reduction to the national standardized 60-day
episode rates, the national per-visit rates, the LUPA add-on payment
amount, and the NRS conversion factor to fund the proposed target of
approximately 2.5 percent of total estimated HH PPS payments in outlier
payments, adhering to the statutory requirement in Section 1895(b)(3)
of the Act.
3. Proposed Outlier Cap Policy
Although program integrity efforts associated with excessive
outlier payments continue in targeted areas of the country, we continue
to be at risk of exceeding the 5 percent statutory limit on estimated
outlier expenditures. Therefore, our recent analysis also focused on
whether a broader policy change to our outlier payment policy might
also be warranted, to mitigate possible billing vulnerabilities
associated with excessive outlier payments, and to adhere to our
statutory limit on outlier payments.
We also considered eliminating outlier payments altogether and
restoring the 5 percent, originally taken out of the national
standardized 60-day episode rates, the national per-visit rates, the
LUPA add-on payment amount, and the NRS conversion factor to pay for
the existing outlier policy, back into the HH PPS rates. Eliminating
outlier payments would simplify payments to HHAs and remove the
vulnerability associated with inappropriate outlier payments. However,
we are concerned that eliminating outlier payments to HHAs could result
in denying added protection to HHAs that historically treat sicker,
more costly patients.
In attempts to better estimate outlier payments as a percentage of
total HH PPS payments and to mitigate vulnerabilities associated with
inappropriate outlier payments, we also looked into options that would
impose an outlier cap, at the agency level, such that in any given
year, an individual HHA would receive no more than a set percentage of
its total HH PPS payments in outlier payments. We performed extensive
analyses to model the impact to HHAs of a variety of percent caps in
outlier payments. A primary focus of this analysis was to identify HHAs
which would be representative of the types of agencies we are most
concerned about disadvantaging with an outlier policy that included an
outlier cap at the agency level. Our analysis revealed that a 10
percent agency cap in outlier payments would mitigate potential
inappropriate outlier billing vulnerabilities while minimizing the
access to care risk for high needs patients.
We used CY 2007 claims data to perform a detailed impact analysis.
We identified 1137 HH agencies whose outlier payments exceeded 10
percent of their total HH PPS payments in CY 2007. However, we excluded
700 of these agencies from the impact analysis, because these agencies
received sizeable outlier payments (totaling at least around $100,000),
had high percentages (at least around 30 percent) of outlier payments
to total HH PPS payments, and were located in the counties in FL, TX
and CA where we believe possible program integrity issues had been
identified.
We targeted our in-depth impact analysis to the remaining 437
agencies, about 5 percent of all Medicare home health agencies. We
analyzed these agencies as a group and individually. Our analysis
focused on total HH PPS payments, total outlier payments, number of
episodes, number of outlier episodes, percentage reductions in payments
if a 10 percent outlier cap were imposed, and location. Analyzing CY
2007 data, these 437 agencies would have experienced about a 10 percent
decrease in their total HH payments if an outlier cap of 10 percent, at
the agency level, were imposed. As we looked closely at the individual
437 agencies, we excluded additional agencies for a number of reasons.
Specifically, we excluded 70 agencies that had fewer than 20 Medicare
HH episodes, believing that Medicare beneficiaries account for such a
small part of their business that they are not representative of the
types of agencies we are most concerned about disadvantaging with an
outlier cap policy.
We excluded an additional 197 agencies because they are also
located in the counties identified as experiencing program integrity
problems. While these 197 agen