[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Proposed Rules]
[Pages 43236-43306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17753]
[[Page 43235]]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 409, 418, 424, et al.
Medicare Program; Home Health Prospective Payment System Rate Update
for Calendar Year 2011; Changes in Certification Requirements for Home
Health Agencies and Hospices; Proposed Rule
Federal Register / Vol. 75 , No. 141 / Friday, July 23, 2010 /
Proposed Rules
[[Page 43236]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409, 418, 424, 484, and 489
[CMS-1510-P]
RIN 0938-AP88
Medicare Program; Home Health Prospective Payment System Rate
Update for Calendar Year 2011; Changes in Certification Requirements
for Home Health Agencies and Hospices
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would set forth an update to the Home
Health Prospective Payment System (HH PPS) rates, including: The
national standardized 60-day episode rates, the national per-visit
rates, the non-routine medical supply (NRS) conversion factors, and the
low utilization payment amount (LUPA) add-on payment amounts, under the
Medicare prospective payment system for HHAs effective January 1, 2011.
This rule also proposes to update the wage index used under the HH PPS
and, in accordance with The Affordable Care Act of 2010 (The Affordable
Care Act), Public Law 111-148, to update the HH PPS outlier policy. In
addition, this rule proposes changes to the home health agency (HHA)
capitalization requirements. This rule further proposes to add
clarifying language to the ``skilled services'' section. Finally, this
rule incorporates new legislative requirements regarding face-to-face
encounters with providers related to home health and hospice care.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 14,
2010.
ADDRESSES: In commenting, please refer to file code CMS-1510-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 http://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-1510-P, P.O. Box 1850,
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-1510-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.
FOR FURTHER INFORMATION CONTACT:
Randy Throndset, (410) 786-0131 (overall HH PPS).
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).
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: http://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.
Table of Contents
I. Background
A. Statutory Background
B. System for Payment of Home Health Services
C. Updates to the HH PPS
II. Provisions of the Proposed Regulation
A. Case-Mix Measurement
B. Hypertension Diagnosis Coding Under the HH-PPS
C. Therapy Coverage Requirements
D. Collecting Additional Claims Data for Future HH PPS
Enhancements and Soliciting Comments on HH PPS Improvements
E. Outlier Policy
1. Background
2. Regulatory Update
3. Statutory Update
4. Outlier Cap
5. Loss Sharing Ratio and Fixed Dollar Ratio
6. Solicitation of Comments Regarding Imputed Costs
F. Proposed CY 2011 Payment Update
1. Home Health Market Basket Update
2. Home Health Care Quality Improvement
a. OASIS
b. Home Health Care CAHPS Survey (HH CAHPS)
3. Home Health Wage Index
4. Proposed CY 2011 Payment Update
a. National Standardized 60-Day Episode Rate
b. Proposed Updated CY 2011 National Standardized 60-Day Episode
Payment Rate
c. Proposed National Per-Visit Rates Used To Pay LUPA's and
Compute Imputed Costs Used in Outlier Calculations
[[Page 43237]]
d. Proposed LUPA Add-On Payment Amount Update
e. Non-Routine Medical Supply Commission Factor Update
5. Rural Add-On
G. Enrollment Provisions for HHAs
1. HHA Capitalization
2. Change of Ownership
3. Change in Majority Ownership Within 36 Months of Initial
Enrollment or Change in Ownership
H. Home Health Face-to-Face Encounter
I. Solicitation of Comments: Future Plans To Group HH PPS Claims
Centrally During Claims Processing
J. Proposed New Requirements Affecting Hospice Certifications
and Recertification
III. Collection of Information Requirements
IV. Regulatory Impact Analysis
I. Background
A. Statutory Background
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 retrospective 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
that such amounts be initially based on the most recent audited cost
report data available to the Secretary, and (2) the standardized
prospective payment amount be adjusted to account for the effects of
case-mix and wage level differences 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, as amended by Section 3131 of the
Affordable Care Act signed by the President on March 23, 2010 (Pub. L.
111-148), 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. Section 3131(b) revised Section 1895(b)(5) so
that total outlier payments in a given fiscal year (FY) or year may not
exceed 2.5 percent of total payments projected or estimated.
In accordance with the statute, as amended by the BBA, we published
a final rule (65 FR 41128) in the Federal Register on July 3, 2000, to
implement the 1997 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).
On February 8, 2006, the Deficit Reduction Act of 2005 (Pub. L.
109-171) (DRA) was enacted. Section 5201 of the DRA added new Section
1895(b)(3)(B)(v) to the Act, which 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 is 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, which was
codified at 42 CFR 484.225(h) and (i).
The Affordable Care Act made additional changes to the HH PPS. One
of the changes in section 3131 of the Affordable Care Act is the
amendment to section 421(a) of the Medicare Prescription Drug,
Improvement, and Modernization Act (MMA) of 2003 (Pub. L. 108-173) as
amended by section 5201(b) of the Deficit Reduction Act of 2005 (Pub.
L. 109-171). The amended section 421(a) of the MMA requires, for home
health services furnished in a rural area (as defined in section
1886(d)(2)(D) of the Act) with respect to episodes and visits ending on
or after April 1, 2010 and before January 1, 2016, that the Secretary
increase by 3 percent the payment amount otherwise made under section
1895 of the Act.
B. 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). Payment for durable medical
equipment covered under the home health benefit is made 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
[[Page 43238]]
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 partial episode payment
adjustment (PEP adjustment). For certain cases that exceed a specific
cost threshold, an outlier adjustment may also be available.
C. 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.
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 analysis performed on CY 2005 home health claims data
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. Then a more detailed analysis was
performed 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 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.
Most recently, we published a final rule in the Federal Register on
November 10, 2009 (74 FR 58077) 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
2010.
II. Provisions of the Proposed Regulation
A. Case-Mix Measurement
Since the HH PPS CY 2008 proposed rule, we have stated in HH PPS
rulemaking that we would continue to monitor case-mix changes in the HH
PPS and to update our analysis to measure change in case-mix, both
nominal and real. We have continued to monitor case-mix changes, and
our latest analysis continues to support the payment adjustments which
we implemented in the CY 2008 HH PPS. As discussed in the CY 2010 rule,
the analysis then 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, we used data from the pre-
PPS period to estimate a regression-based, predictive model of
individual case-mix weights based on measures of patients' demographic
characteristics, clinical status, inpatient history, and Medicare costs
in the time period leading up to their home health episodes. The
regression coefficients from this model were applied to later episodes,
allowing estimation of how much of the change in observed case-mix is
attributable to changes in patient characteristics over time. We
classify the sources of case-mix change into two major types: predicted
and unpredicted. Predicted (or real) change is based on the
relationship between patient characteristics and case-mix (that is
coefficients from the regression model) and changes in the
characteristics of patients over time (that is the change in mean
values of the model covariates). Unpredicted (or nominal) change is the
portion of case-mix change that cannot be explained by changes in
patient characteristics. Nominal case-mix change is assumed to reflect
differences over time in agency coding practices.
Our best estimate in the CY 2010 rule was that approximately 9.77
percent of the 15.03 percent increase in the overall observed case-mix
between the IPS baseline and 2007 was real, that is, due to actual
changes in patient characteristics. Our estimate was that a 13.56
percent nominal increase (15.03--(15.03 x 0.0977)) in case-mix was due
to changes in coding procedures and documentation rather than to
treatment of more resource-intensive patients.
We have since updated that analysis to include an additional year
of data (CY 2008) for this CY 2011 proposed rule. This analysis was
based on regression coefficients from CY 2008 episodes that reflect the
relationship between model covariates and case-mix using the HHRG153
system. We used these regression coefficients combined with changes in
patient characteristics to measure the amount of predicted case mix
change for 2007 through 2008.
Our analyses indicate a 19.40 percent increase in the overall
observed case-mix since 2000. Our estimate is that approximately 10.07
percent of the total increase in the overall observed case-mix between
the IPS baseline and 2008 is real, that is, associated with actual
changes in patient characteristics. Specifics regarding this analysis
are described later in this section.
The estimate of real case-mix change is a small proportion of the
total change in case mix since the IPS baseline. With each successive
sample, beginning with 2005 data (in the CY 2008 final rule), the
predicted average national case-mix weight has changed very little
because the variables (such as preadmission location, non-home health
Part A Medicare expenditures, and inpatient stay classification, as
mentioned above) in the model used to predict case-mix are not changing
much. At the same time, the actual average case-mix has continued 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, has increased with each successive year of data.
Consequently, as a result of this analysis, we recognize that a 17.45
percent nominal increase (19.40 - (19.40 x 0.1007)) in case-mix is due
to changes in coding practices and documentation rather than to
treatment of more resource-intensive patients. This 17.45 percent
increase in case mix reflects a much larger increase in nominal case-
mix from the IPS baseline to 2008 than had been previously been
occurring under the HH PPS. Specifically, from 2000 to 2007, we
observed about a 1 percent per year increase in total average case-mix.
However, that annual change increased to slightly more than 4 percent
between 2007 and 2008.
We wanted to determine how this growth in case-mix weight from 2007
to 2008 was affected by the changes implemented with the 2008
refinements. We identified these average case-mix values by estimating
the average case mix weight on the 2007 claims of a random 20 percent
sample of HH beneficiaries. We used two groupers--the 80-group 2007
grouper
[[Page 43239]]
(average = 1.2606) and the 153-group 2008 grouper (average = 1.2552).
The difference in averages was -0.0054, indicating that the changeover
to the new 2008 grouper algorithm itself slightly reduced the average
case mix weight.
Next, to assess behavioral changes which may have been incentivized
by the 2008 refinements, we estimated the average case mix weights on
both 2007 claims data and 2008 claims data for a random 20 percent
sample of HH beneficiaries, using the 2008 grouper. (Only non-LUPA
episodes are included in this analysis, as LUPA episodes are not paid
using case mix weights.) We compared the resulting averages. The total
change using the 2008 grouper was 0.0533: the 2007 average was 1.2552
and the 2008 average was 1.3085. It is important to note that this
comparison of the 2007 and 2008 claims data uses the same grouper (the
153-group system, which includes co-morbid conditions), and that this
estimate of national average case-mix on the 2007 sample differs very
little (that is -.0054) from the estimate we derived from using the
actual grouper in effect in 2007.
We decomposed the change in average case-mix weight, 0.0533, into
an effect of the 2007-2008 shift in the distribution of the number of
therapy visits per episode, and an effect of the 2007-2008 change in
the average case-mix weight at each count of therapy visits in the
distribution. The latter is assumed to result mostly from the
incentives to report co-morbid conditions, stemming from the
introduction of the 153 group system.
The former is assumed to result mostly from a behavioral response
on the part of agencies to the new system of therapy thresholds
introduced in 2008. Prior to 2008, case mix weights were generally
highest for episodes that met the single, 10-visit therapy threshold.
Under the system in place since 2008, multiple thresholds above and
below 10 therapy visits were created. By creating multiple thresholds
and severity steps between thresholds, we intended to move incentives
away from payment-driven therapy treatment plans to clinically driven
ones. However, creating a new set of high therapy thresholds above 13
therapy visits, to adequately compensate agencies for treating the
relatively few patients needing such large amounts of therapy, also may
have had unintended consequences. One such consequence may have been
that agencies responded by padding treatment plans to reach the new,
higher thresholds. Episodes which would require such high numbers of
therapy visits generally would have very high case mix weights (mostly
weights of 2 or higher).
The decomposition method first holds the average case mix weight
constant (at the 2007 values) at each level of therapy visits, and
measures the effect of the shift to the new distribution of therapy
visits. The method then holds the distribution of therapy visits
constant (at the 2007 distribution) and measures the effect of the
change in average case mix weight at each level of therapy visits. The
results were that .0205, or 38 percent (.0205/.0533=.38), of the total
change in average case-mix weights from 2007 to 2008 was due to the
shift in distribution of therapy visits per episode.
Figure 1 illustrates the 2007 through 2008 change in the proportion
of episodes delivering each individual number of therapy visits.
Several changes are notable. First, the percentage of episodes
increased at the new, higher therapy visit thresholds (14-19 and 20+).
The share of episodes at 20 visits or more increased from 4.4 percent
in 2007 to 5.3 percent in 2008, a substantial increase of about 20
percent. The large shift towards therapy visit levels of 14 and higher
was unexpected.
Second, the percentage of episodes at the single therapy threshold
(10 visits) that existed before 2008 decreased, as did the percentage
of episodes between 11 and 13 therapy visits. In 2007, as a proportion
of all episodes with at least one therapy visit, episodes with 10 to 13
therapy visits were 32 percent; by 2008, only 21 percent of all therapy
episodes were in this range. (Note: Figure 1 displays percents of total
non-LUPA episodes, not just episodes with at least one therapy visit.)
Third, the proportion of episodes at the new threshold below 10 visits,
which is 6 visits, increased, as did the proportion of episodes with 7,
8, or 9 visits. The system of therapy steps we defined for the 2008
refinements included a step for 7-9 visits (see Table 4 of The August
29, 2007 final rule [72 FR 49762]). Finally, the proportion of total
episodes receiving any therapy visits increased slightly, from 54
percent to 55 percent. The average number of therapy visits per episode
increased from 5.63 to 5.83 (data not shown).
BILLING CODE 4120-01-P
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[GRAPHIC] [TIFF OMITTED] TP23JY10.000
BILLING CODE 4120-01-C
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The remaining .0328, or 62 percent of the total change
(.0328/.0533=.62) in overall average case-mix weight from 2007 to 2008
was due to an increase in the average case-mix weight at each level of
therapy visits per episode. Table 1 shows the increases.
[GRAPHIC] [TIFF OMITTED] TP23JY10.001
The averages increased for all levels of therapy visits per
episode, with the change ranging from 0.02 to 0.05. The percentage
changes appear to decline with more therapy visits, because the level
of the average case mix value increases with each number of therapy
visits; however, there was no rising trend in the absolute change as
the number of therapy visits increased.
Looking directly into the reporting of comorbidities, we examined
the proportion of episodes that had nonblank diagnoses reported in
M0240 (Diagnoses and Severity Index). Our concern was that agencies
were reporting more comorbidities, since the refined system allocates
case mix points for secondary diagnoses, whereas the system prior to
the refinements did not. Longstanding OASIS manual language instructs
providers to encode diagnosis on the OASIS only when the condition is
unresolved and only when the condition has an impact on the home health
care. The data comparing the percentages are shown in Table 2.
The results were a substantial increase in the percentage of
episodes with a reported diagnosis code in M0240: A 10.4 percentage
point increase from 2007-2008 in M0240d; a 16.4 percentage point
increase in M0240e; and a 19.9 percentage point increase in M0240f.
Table 2 also indicates that these changes represented a significantly
larger increase in completion rates in these diagnosis fields compared
to annual increases of about 3.0 percentage points in 2005-2006, and
about 7.0 percentage points in 2006-2007. We note that we published the
proposed refinements in the May 2007 Federal Register (72 FR 25356).
Release of the proposal around mid-year could have been a factor in the
higher growth of these episodes during the period 2006 through 2007,
relative to 2005 through 2006.
We believe it is unlikely that the actual disease burden of home
health patients, as indicated by reported comorbidities, changed so
dramatically in a single year; instead, we believe the incentives to
report more comorbidities under the refined case mix system are the
reason for the large increases in reported comorbidities.
[[Page 43242]]
[GRAPHIC] [TIFF OMITTED] TP23JY10.002
An illustrative instance of diagnosis coding change under the HH
PPS refinements is hypertension. Our analysis of 8 years of claims
shows that reporting of this diagnosis grew exceedingly quickly in
2008. Table 3 shows the proportion of HH PPS claims reporting essential
hypertension, according to ICD-9-CM hypertension code, for 2001 to
2008. The data indicate a sudden jump of approximately 12 percentage
points in reporting of unspecified hypertension when the refined HH PPS
added hypertension as a case mix code in 2008. Annual changes in use of
this code were small up until 2005 (in the range of 0.1 to 2.4
percentage points), after which there were two years of 6-percentage
point increases, followed by the 12-percentage point increase
coincident with the 2008 refinements. Malignant hypertension is
unusual; it has been falling as a percentage of episodes. Reporting of
benign hypertension, which is somewhat more common than malignant
hypertension, has been slowly rising since 2001.
[GRAPHIC] [TIFF OMITTED] TP23JY10.003
At the same time, there are indications that the services
utilization associated with the most commonly reported hypertension
diagnosis code, hypertension, unspecified, no longer is responsible for
added resource requirements in home care. Originally, hypertension was
selected for inclusion in the refined HH PPS system because data
suggested it elevated utilization. Table 4a illustrates the trends; it
shows the average number of visits per episode, according to type of
hypertension diagnosis code. (We exclude outlier cases because of the
effect that growing numbers of outlier episodes may have had beginning
around 2005 and 2006; extremely large numbers of visits in the
distribution can distort the average.)
Generally episodes reporting malignant or benign hypertension
exhibit a decline in number of visits per episode during the middle of
the 8-year
[[Page 43243]]
period. The averages then rise slightly. The averages for episodes
reporting unspecified hypertension declined until 2005, and then
stabilized.
Comparing these data with averages for episodes not reporting
hypertension, we see that hypertension is generally associated with
more visits, especially if the hypertension was reported as malignant
or benign. However, in 2007, the unspecified hypertension episodes had
an average number of visits equivalent to that of the non-HBP episodes.
By 2008, the average number of visits for episodes not reporting
hypertension rose slightly, while the average for unspecified
hypertension did not. As a result, by 2008, the average number of
visits for claims reporting unspecified hypertension is slightly lower
than the average for claims not reporting hypertension. Further, the
benign hypertension episodes, with a slightly increased share of the
sample between 2007 and 2008, exhibited a small reduction in the
average number of visits.
[GRAPHIC] [TIFF OMITTED] TP23JY10.004
This pattern illustrates an expected effect of nominal coding
change. We observe a 12-percentage point increase in use of unspecified
hypertension, but no longer do these hypertension patients use more
resources than others. These results appear possibly consistent with a
phenomenon in which agencies increased their reporting of hypertension
in situations where it did not meet the home health diagnosis reporting
criteria. More generally, the results are suggestive of changed coding
practice in which less-severe episodes are being reported with
hypertension in 2008 than used to be the case.
These analyses of the change in the therapy visit distribution,
change in average case mix weights at each level of therapy visits,
increased use of secondary diagnosis fields, and the change in
reporting of hypertension all suggest that the refinements which were
implemented in 2008 affected case-mix weights, with greater therapy
visits and reporting of co-morbidities each as contributing factors.
However, as described below, the analyses do not indicate a significant
increase in real case-mix. Experience with previous analyses reported
in our past regulations shows that relatively small proportions of the
total case mix change since the IPS baseline can be considered real
case mix change.
Our estimate that 10.07 percent of the total percentage change in
the national average case mix weight since the IPS baseline is due to
real change in case mix, is consistent with past results. Most of the
case mix change has been due to improved coding, coding practice
changes, and other behavioral responses to the prospective payment
system, such as more use of high therapy treatment plans. We are
therefore proposing to exercise authority to compensate for nominal
case mix change by making reductions to the PPS rates, as we have done
since 2008.
For this year's analysis, we used the same approach, a model
designed to measure real change in case mix, which we developed for the
CY 2008 HH PPS final rule (72 FR 49841) and continue to use for HH PPS
rulemaking. For this year's analyses, we utilized a fuller version of
the 3M APR-DRG grouper that allowed us to expand the number of APR-DRG-
related groups in the model. As previously, we included indicators for
each APR-DRG group's different severity level if at least 25 episodes
had the APR-DRG/severity combination in the IPS period file. This
expanded APR-DRG model was used to re-estimate the IPS period model of
case-mix weight.
We also rebased the expanded APR-DRG model on CY2008 data, using
case-mix weights produced by the refined (153-group) HH PPS grouper.
One slight difference in the rebased model is that because we are using
2008 data, the ``living arrangement'' variables are missing on follow-
up OASIS assessments. Consequently, we were not able to use this
variable in the re-based model.
We used the results of that rebasing to predict real case mix for
2007. The national average case mix weight in 2008 was 1.3085. The
rebased model of real case mix predicts a quantity change in real case
mix of -0.0025 when working backwards from 2008 (1.3085) to 2007
(1.3060). The predicted level of real case mix in 2007, which we
derived from the IPS-based model is 1.1152. To compute a predicted real
case mix level for 2008, we increased the predicted level of real case
mix in 2007, 1.1152, by the percentage growth (1.3085/1.3060) in real
case mix that we estimated from the rebased model. The result is a
predicted level of real case
[[Page 43244]]
mix in 2008 of 1.1173 ((1.3085/1.3060) x 1.1152 = 1.1173).
To compute the predicted quantity change in real case mix from the
IPS baseline to 2008, we subtracted from the IPS baseline average case
mix weight from the predicted level the real case mix in IPS, for a
quantity change of 0.0214 (1.1173 - 1.0959 = 0.0214). The total
difference in case mix from baseline to 2008 is 0.2126 (1.3085 - 1.0959
= 0.2126). Therefore, the quantity change from baseline to 2008 in real
case mix represents a 10.07 percent increase (0.0214/0.2126 = 0.1007 or
10.07 percent).
The percent change in overall case mix from the IPS baseline to
2008 is 19.40 percent ((1.3085/1.0959) - 1 = 0.1940 or 19.40 percent).
To estimate the percent growth in case mix due to nominal change (that
is, change in case mix not due to actual changes in patient acuity), we
reduced the overall 19.40 percent change in case mix by the 10.07
percent increase due to real case mix change, which yielded a residual
of 17.45 percent ((1 - 0.1007) * 0.1940 = 0.1745).
As we fully described earlier in this proposed rule, our August 29,
2007, final rule for CY 2008 finalized a reduction over 4 years in the
national standardized 60-day episode payments rates to account for an
11.75 percent increase in case-mix which was not related to treatment
of more resource intense patients. The 11.75 percent increase was based
on an analysis of data through 2005. We finalized a 2.75 percent
reduction each year for 2008, 2009 and 2010, and 2.71 percent reduction
for CY 2011 to account for this growth in case-mix. We have stated in
HH PPS rulemaking, since the CY 2008 HH PPS proposed rule, that we
might find it necessary to adjust the annual offsets (case-mix
reduction percentages) as new data became available. Because our
current analysis reveals that nominal case-mix has continued to grow,
we are faced with having to account for the additional increase in
nominal case-mix beyond that which was identified for CY 2008
rulemaking. If we were to account for the remainder of the 17.45
percent residual increase in nominal case-mix over CY 2011 and CY 2012,
we estimate that the percentage reduction to the national standardized
60-day episode rates and the NRS conversion factor for nominal case-mix
change for each of the two calendar years (2011 and 2012) of the case-
mix change adjustment would be 3.79 percent per year. If we were to
fully account for the remaining residual increase in nominal case-mix
in CY 2011, we estimate that the percentage reduction to the national
standardized 60-day episode rates and the NRS conversion factor would
be 7.43 percent. Because the Affordable Care Act contains other
provisions which have an effect on HH PPS payments, we are not
proposing to account for the entire residual increase in nominal case-
mix in CY 2011, instead we propose to account for the identified
increase over CY 2011 and CY 2012. We propose to impose a 3.79 percent
reduction per year to the national standardized 60-day episode rates
and the NRS conversion factor for CY 2011 and CY 2012. Should we
identify further increases in nominal case-mix as more current data
become available, it is our intent to account fully for those increases
when they are identified, rather than continuing to phase-in the
reductions over more than 1 year. We will continue to monitor any
future changes in case-mix as more current data become available and
make updates as appropriate.
B. Hypertension Diagnosis Coding Under the HH PPS
As part of this rule, we are proposing to remove ICD-9-CM code
401.9, Unspecified Essential Hypertension, and ICD-9-CM code 401.1,
Benign Hypertension, from the HH PPS case mix model's hypertension
group, originally reflected in Table 2B of the August 29, 2007, CY 2008
HH PPS final rule (72 FR 49762) (subsequent updates to Table 2B have
been provided in HH PPS grouper software releases). In this section we
explain the basis for this proposal.
As part of our refinements to the HH PPS, beginning in CY 2008,
unspecified hypertension and benign hypertension were included as
diagnoses in our HH PPS case mix system. Recent analysis of home health
diagnosis coding shows a significant change in the frequency of
assigning certain hypertension diagnoses during CY 2008. Specifically,
our analysis of HH PPS claims from 2001 to 2008 shows a sudden increase
in the reporting of unspecified hypertension and benign hypertension on
home health claims in CY 2008 (see Table 3: Percent of episodes
reporting hypertension ICD-9-CM diagnosis codes: 2001-2008, of this
proposed rule).
Classification of blood pressure (BP) was revised in 2003 by the
National Heart, Lung and Blood Institute (NHLBI) in their ``Seventh
Report of the Joint National Committee on Prevention, Detection,
Evaluation, and Treatment of High Blood Pressure'' (the JNC 7 report)
and published in the May 21, 2003, Journal of the American Medical
Association. These revisions provided specific clinical guidelines for
prevention, detection, and treatment of high blood pressure. The
guidelines, approved by the Coordinating Committee of the NHLBI's
National High Blood Pressure Education Program (NHBPEP), also
streamlined the steps by which doctors diagnose and treat patients. A
key aspect of the guidelines includes the introduction of a ``pre-
hypertension'' level for individuals with a systolic blood pressure of
120-139 mm Hg or a diastolic blood pressure of 80-89 mm Hg. This
recognition represented a change from traditional medical views on the
implications of blood pressures slightly above 120/80. Traditionally,
such low levels were not considered a significant clinical finding. No
diagnosis was reportable. There was no medical treatment ordered; nor
was a change of lifestyle recommended.
Based upon our review of the revised clinical guidelines, and our
review of the ICD-9-CM classification of essential hypertension, if the
patient is considered ``pre-hypertensive,'' some may conclude that a
diagnosis of benign hypertension may be assigned. If an individual is
designated as pre-hypertensive, the guidelines stipulate that this
individual will generally require health promoting lifestyle
modifications to prevent cardiovascular disease. Additional treatments
may or may not be appropriate.
The impact of the new guidelines for hypertension is the
reclassification of certain patients to a hypertension diagnosis,
whereas prior to the guidelines, no hypertension diagnosis was
indicated. Furthermore, under the guidelines, some of the patients
deemed hypertensive may not need skilled services. Moreover, as we
described above, we see a substantial increase in the reporting of
unspecified hypertension, along with some evidence that home health
patients with either unspecified or benign hypertension no longer
require extra resources. Given the new guidelines for hypertension and
their impact on coding, along with coding behavior changes in 2008, we
believe including unspecified and benign hypertension in the HH PPS
case mix model reduces the model's accuracy. As such we do not believe
that we should be including these diagnoses in our case-mix system.
We also believe that the developments in clinical guidelines of
recent years may have led to ambiguity in the definition of
hypertension in the ICD-9-CM classification system. The ``ICD-9-CM
Official Guidelines for Coding and Reporting'', and the alphabetic and
tabular indexes of the ICD-9-CM published after May 2003 (effective
date
[[Page 43245]]
of the ``NHLBI Guidelines for Hypertension''), fail to include the
NHLBI Blood Pressure (BP) guidelines and classification terminology.
The NHLBI specific BP mmHg measurements and BP terms are not included
in the ICD-9-CM classification system.
In the August 29, 2007, CY 2008 HH PPS final rule, we removed
diagnosis codes proposed in the NPRM if the code was assigned to a
minor condition or mild symptom that may be found in the elderly
population; codes that are non-specific or ambiguous; and codes that
lack consensus for clear diagnostic criteria within the medical
community. Due to their unclear relationship with NHLIB guidelines, the
unspecified and benign hypertension codes fail to meet the criteria we
laid out in 2007.
In summary, continued inclusion of the unspecified and benign
hypertension codes in the HH PPS case mix system threatens to move the
HH PPS case-mix model away from a foundation of reliable and meaningful
diagnosis codes that are appropriate for home care. Therefore, we are
proposing to remove ICD-9-CM code 401.9, Unspecified Essential
Hypertension, and ICD-9-CM code 401.1, Benign Essential Hypertension,
from the HH PPS case mix model's hypertension group, in order to
correlate with the goals of our HH PPS case-mix system.
C. Therapy Coverage Requirements
With the inception of the HH PPS, as set forth in the July 3, 2000
final rule (65 FR 41128), patients were grouped according to their
therapy utilization status in order to ensure that patients who
required therapy would maintain access to appropriate services. In the
final rule, we described that we had performed research regarding how
to use assessment information to predict how much therapy a patient
would need over the course of a 60-day period. The research found that
the assessment data could not predict the amount of required therapy
with sufficient accuracy for use in the payment system. Knowing that
under a PPS there is significant risk that providers might skimp on
high-cost services such as therapy, we decided to establish a therapy
threshold to ensure that therapy would not be under-provided. We used
clinical judgment to determine what amount of therapy would need to be
provided to ensure a meaningful amount of rehabilitation services to
patients who could clearly benefit from it. We determined that this
amount would be at least 8 hours of therapy services during the 60-day
episode. Since the average therapy visit was 48 minutes long, it would
take 10 visits to provide at least 8 hours worth of therapy. Therefore,
we established a corresponding 10-visit therapy threshold to identify
``high'' therapy cases, and paid home health agencies significantly
more for patients receiving high therapy.
In the years following the adoption of the HH PPS, we have
continued to analyze the effectiveness of the 10-visit therapy
threshold in ensuring that rehabilitation services were being provided
to patients who could clearly benefit from them. Our analyses suggested
that therapy was not being under-provided, but rather suggested that in
many cases therapy was being over-provided. As described in the May 4,
2007 HH PPS proposed rule (72 FR 25356), our analysis of the evidence
suggested that the single 10-visit threshold offered too strong a
financial incentive to provide 10 therapy visits when a lower amount of
therapy was more clinically appropriate. In other words, the data
suggested that financial incentives to provide 10 therapy visits
overpowered clinical considerations in therapy prescriptions. During
this time we conducted further research to model therapy need, but it
was again unsuccessful. We explained in our proposed rule in May 2007
that a return to per-visit payment for therapy visits did not meet our
objectives for having a prospective payment system. Therefore, in the
CY 2008 final rule, we established a system of three thresholds with
graduated steps in between which met our objectives of retaining
prospectivity in the payment system, reducing the strong incentive
resulting from a single threshold, restoring clinical considerations in
therapy provision, and paying more accurately for therapy utilization
below the original 10-visit threshold. Those three thresholds are at 6
therapy visits, 14 therapy visits, and 20 therapy visits. As a
disincentive for agencies to deliver more than the appropriate,
clinically determined number of therapy visits, payment for additional
therapy visits between the three thresholds increases gradually,
incorporating a declining rather than a constant payment amount per
added therapy visit. In our May 4, 2007 HH PPS proposed rule, at 72 FR
25363, we provided further details explaining the selection of these
thresholds.
Analysis of CY 2008 data continues to suggest that some HHAs may be
providing unnecessary therapy. The 2008 data show a 30 percent increase
in episodes with between 6-9 therapy visits, which suggests that the
2008 changes may have been successful in improving clinical
considerations in the volume of therapy provided. In their March 2010
report MedPAC states that 2008 data also reveal a 26 percent increase
of episodes with 14 or more therapy visits (MedPAC, Report to Congress:
Medicare Payment Policy, Section B, Chapter 3, March 2010, p. 203). The
increase in episodes with 14 or more therapy visits is especially
evident in areas of the country where home health fraud is suspected,
such as Miami-Dade, Florida.
While this suggests that the therapy payment policies are
vulnerable to fraud and abuse, the swift, across-the-board therapy
utilization changes suggest another, more fundamental concern. MedPAC
wrote that the magnitude of therapy utilization changes and their
correlations with the payment threshold changes suggest that payment
incentives continue to influence treatment patterns [MedPAC, 2010, p.
206]. The Commissioners believed that payment policy is such a
significant factor in treatment patterns because the criteria for
receipt of the home health benefit are ill-defined. They suggested that
improved guidelines that more specifically identify patients who are
most appropriate for HH care would facilitate more appropriate and
uniform use of the benefit [MedPAC, 2010, p. 203]. To address the
concerns of MedPAC, we are proposing to clarify our policies regarding
coverage of therapy services at 409.44(c) in order to assist HHAs, and
to curb misuse of the benefit.
We believe these clarifications also could slow the case-mix growth
which is unrelated to real changes in patient acuity (nominal case-
mix). As we described above in Section A (``Case Mix Measurement''),
between 2007 and 2008 we observed a case-mix increase of more than 4
percent. An analysis of this growth revealed that approximately 38
percent of the total case mix change between 2007 and 2008 was due to
the shift in distribution of therapy visits. By describing more clearly
the therapy coverage criteria in the home health setting, thereby
enabling providers to better understand when providing therapy to home
health patients is appropriate, we believe that beginning in calendar
year 2011, a slower rate of nominal case-mix growth may be achieved.
Proposed Clarifications to 42 CFR 409.44(c)(1)
Regulations at Sec. 409.44(c)(1) mandate that for physical
therapy, speech language pathology, or occupational therapy to be
covered under the home health benefit, therapy services must
[[Page 43246]]
relate directly and specifically to a treatment regimen, be established
by the physician (after any needed consultation with a qualified
therapist), that is designed to treat the beneficiary's illness or
injury. A qualified therapist is one who meets the personnel
requirements in the CoPs at 42 CFR 484.4. To ensure that therapy
services relate directly and specifically to a treatment regimen
designed to treat the beneficiary's illness or injury, we are proposing
to clarify our coverage requirements. Specifically, we are proposing to
revise Sec. 409.44(c)(1) so that, with respect to physical therapy,
occupational therapy, and speech language pathology, we may clarify
that:
The patient's plan of care would include a course of
therapy and therapy goals which would be consistent with the patient's
functional assessment, both of which are included in the patient's
clinical record. The patient's clinical record would document the
necessity for the course of therapy described in the plan of care.
Specifically, the clinical record would document how the course of
therapy for the beneficiary's illness or injury is in accordance with
accepted standards of clinical practice.
Therapy treatment goals would be described in the plan of
care, and they would be measurable. Specifically, therapy treatment
goals would be such that progress toward those goals could be
objectively measured. The goals would also pertain directly to the
patient's illness or injury and the patient's resultant functional
impairments.
The patient's clinical record would demonstrate that the
method used to assess a patient's function included the objective
measurement of function in accordance with accepted standards of
clinical practice. As such, successive functional assessments would
enable comparison of successive measurements, thus enabling objective
measurement of therapy progress.
One example of objective measures is functional assessment
individual item and summary findings (and comparisons to prior
assessment results/clinical findings) from OASIS functional items or
other commercially available therapy outcomes instruments. Similarly,
another example would be functional assessment findings (and
comparisons to prior assessment results/clinical findings) from tests
and measurements validated in the professional literature, or used as
part of accepted standards of clinical practice that are appropriate
for the condition/function being measured.
Proposed Clarifications to 42 CFR 409.44(c)(2)(i)
Current regulations at Sec. 409.44(c)(2)(i) mandate that for
physical therapy, speech language pathology, or occupational therapy
services to be covered in the home health setting, the services must be
considered under accepted practices to be a specific, safe, and
effective treatment for the beneficiary's condition.
To clarify what we mean by ``accepted practice'' and ``effective
treatment'', we are proposing to clarify home health therapy coverage
criteria at Sec. 409.44(c)(2)(i). These clarifications describe our
expectations that HHAs would regularly reassess a therapy patient's
physical function, and would objectively measure a patient's progress
toward therapy goals to determine whether therapy services continued to
be effective, or whether therapy ceased to be covered. These
clarifications also describe clinical record documentation expectations
associated with documenting effective therapy progress.
We are proposing to revise Sec. 409.44(c)(2)(i) as follows:
Functional Reassessment Expectations
In order to ensure that a patient receiving home health therapy
services appropriately remained eligible for the benefit in accordance
with accepted practice, and that the services continued to be
effective, the patient's function would be periodically reassessed by a
qualified therapist. As we described above, for therapy to be covered
in the home health setting, the method used to assess a patient's
function would include objective measurement of function in accordance
with accepted standards of clinical practice. As such, progress toward
therapy goals would be objectively measurable by comparing measurements
obtained at successive functional assessment time points. The objective
measurements obtained from the periodic reassessment of function would
reflect progress (or lack of progress) toward therapy goals, or
achievement of therapy goals and the measurements would be documented
in the clinical record.
While a qualified therapist could include, as part of the
functional assessment or reassessment, objective measurements or
observations made by a PTA or OTA within their scope of practice, the
qualified therapist would have to actively and personally participate
in the functional assessment, and measure the patient's progress.
For those patients requiring 13 or 19 therapy visits, the
patient would be functionally re-assessed by a qualified therapist,
minimally, on the 13th and the 19th therapy visit (thus requiring
reassessment prior to the HH PPS therapy thresholds of 14 and 20
therapy visits), and at least every 30 days.
No subsequent therapy visits would be covered until the
qualified therapist has completed the reassessment, objectively
measured progress (or lack of progress) toward goals, determine if
goals have been achieved or require updating, and documented the
therapy progress in the clinical record. If the objective measurements
of the reassessment do not reveal progress toward goals, the qualified
therapist, together with the physician, would determined whether the
therapy is still effective or should be discontinued. If therapy is
continued, the clinical record would be documented, as described below,
with a clinically supportable statement of why there is an expectation
that anticipated improvement is attainable in a reasonable and
generally predictable period of time.
These reassessments would ensure that the patient was receiving
effective care while also ensuring that, except for covered maintenance
therapy as described later in this section, patients were not remaining
on the benefit and continuing to receive therapy services after the
therapy goals were met, or after improvement could no longer be
expected.
Documenting ``Effective'' Therapy Progress
Assistant's Participation in Documenting ``Effective'' Therapy Progress
We are proposing that physical therapist assistants or occupational
therapy assistants could objectively document progress between the
functional reassessments by a qualified therapist and/or physician.
Clinical notes written by assistants are not complete functional
assessments of progress.
Only a qualified therapist would be able to document a patient's
progress towards goals as measured during a functional reassessment,
regardless of whether the assistant wrote other clinical notes.
However, notes written by assistants are part of the clinical record
and need not be copied into the reassessment documentation. Clinical
notes written by assistants would supplement the functional
reassessment documentation of qualified therapist and would include:
The date that the clinical note was written; the
assistant's signature and job title, or for dictated documentation, the
identification of the assistant who
[[Page 43247]]
composed the clinical note, and the date on which it was dictated;
Objective measurements (preferred) or description of
changes in status relative to each goal currently being addressed in
treatment, if they occurred. Note that assistants would not make
clinical judgments about why progress was or was not made, but could
report the progress objectively.
Descriptions would make identifiable reference to the goals in the
current plan of care.
Qualified Therapist's Responsibility in ``Effective'' Progress
Documentation
In addition to the proposed requirements above for clinical
documentation by assistants, we are also proposing in Sec.
409.44(c)(2)(i) that the patient's progress documentation by a
qualified therapist would also include:
Documentation of objective measurement obtained during the
functional assessment and extent of progress (or lack thereof) toward
each therapy goal.
Plans for continuing or discontinuing treatment, with
reference to evaluation results, and/or treatment plan revisions.
Changes to goals or an updated plan of care that is sent
to the physician for signature or for discharge.
Documentation of objective evidence or a clinically
supportable statement of expectation that: (1) The patient's condition
has the potential to improve or is improving in response to therapy; or
(2) maximum improvement is yet to be attained, and there is an
expectation that the anticipated improvement is attainable in a
reasonable and generally predictable period of time. Objective evidence
would consist of standardized patient assessments, outcome measurement
tools, or measurable assessments of functional outcome. Use of
objective measures at the beginning of treatment, and during and/or
after treatment would be required to quantify progress and support
justifications for continued treatment.
Proposed Clarifications to 42 CFR 409.44(c)(2)(iii)
Regulations at Sec. 409.44(c)(2)(iii) presently mandate that for
therapy services to be covered in the home health setting, there must
be an expectation that the beneficiary's condition will improve
materially in a reasonable (and generally predictable) period of time
based on the physician's assessment of the beneficiary's restoration
potential and unique medical condition, or the services must be
necessary to establish a safe and effective maintenance program
required in connection with a specific disease, or the skills of a
therapist must be necessary to establish a safe and effective
maintenance program in connection with a specific disease or the skills
of a therapist must be necessary to perform a safe and effective
maintenance program. We would clarify these requirements:
The first sentence currently states, ``There must be an
expectation that the beneficiary's condition will improve materially in
a reasonable (and generally predictable) period of time based on the
physician's assessment of the beneficiary's restoration potential and
unique medical condition.''
We propose clarifying the regulatory text to clarify that
``material'' improvement requires that the clinical record demonstrate
that the patient is making functional improvements that are ongoing and
of practical value, when measured against his or her condition at the
start of treatment.
We are proposing to clarify that the concept of rehabilitative
therapy includes recovery or improvement in function and, when
possible, restoration to a previous level of health and well-being.
Covered therapy services under the home health benefit shall be
rehabilitative therapy services unless they meet the criteria for
maintenance therapy requiring the skills of a therapist as described
below.
We are proposing to clarify the regulatory text so that if an
individual's expected rehabilitation potential would be insignificant
in relation to the extent and duration of therapy services required to
achieve such potential, therapy would not be considered reasonable and
necessary, and therefore would not be covered as rehabilitative therapy
services.
We are also proposing to clarify the regulatory text to describe
that therapy is covered as rehabilitative therapy when the skills of a
therapist are necessary to safely and effectively furnish or supervise
a recognized therapy service whose goal is improvement of an impairment
or functional limitation.
We are proposing to clarify in regulatory text that therapy would
not be covered to effect improvement or restoration of function where a
patient suffered a transient and easily reversible loss or reduction of
function (e.g., temporary weakness which may follow a brief period of
bed rest following surgery) which could reasonably be expected to
improve spontaneously as the patient gradually resumes normal
activities. Therapy furnished in such situations would not be
considered reasonable and necessary for the treatment of the
individual's illness or injury, and the services would not be covered.
If at any point in the treatment of an illness, it was determined
that the treatment was not rehabilitative and did not legitimately
require the services of a qualified therapist for management of a
maintenance program as described below, the services would no longer be
considered reasonable and necessary and therapy would cease to be
covered.
As currently stated, Sec. 409.44(c)(2)(iii) also covers
occupational therapy, physical therapy, or speech language pathology if
the services are ``necessary to establish a safe and effective
maintenance program required in connection with a specific disease.''
We are proposing to clarify the existing regulatory text by adding
that the specialized skill, knowledge and judgment of a therapist would
be required in developing a maintenance program, and services would be
covered to design or establish the plan, to ensure patient safety, to
train the patient, family members and/or unskilled personnel in
carrying out the maintenance plan, and to make periodic reevaluations
of the plan.
When indicated, during the last visit(s) for rehabilitative
treatment, the clinician may develop a maintenance program for the
patient. The goals of a maintenance program would be, for example, to
maintain functional status or to prevent decline in function.
We are also proposing to clarify that if a maintenance program was
initiated after the rehabilitative therapy program had been completed
(rather than by a clinician at the last rehabilitative therapy
session), development of a maintenance program would not be considered
reasonable and necessary for the treatment of the patient's condition,
with one exception. We propose that when a patient qualifies for
Medicare's home health benefit based on an intermittent skilled nursing
need, a qualified therapist may develop a maintenance program to
maintain functional status or to prevent decline in function, at any
point in the episode.
The services of a qualified therapist would not be necessary to
carry out a maintenance program, and would not be covered under
ordinary circumstances. The patient could perform such a program
independently or with the assistance of unskilled personnel or family
members.
We also are proposing to clarify circumstances under which CMS
would cover therapy services for carrying out
[[Page 43248]]
a maintenance program. If the clinical condition of the patient were
such that the services required to maintain function involved the use
of complex and sophisticated therapy procedures to be delivered by the
therapist himself/herself (and not an assistant) in order to provide
both a safe and effective maintenance program and to ensure patient
safety, those reasonable and necessary services would be covered, even
if the skills of a therapist were not ordinarily needed to carry out
the activities performed as part of the maintenance program.
Clarifications to Sec. 409.44(c)(2)(iv)
In order to clarify Sec. 409.44(c)(2)(iv), which mandates that for
therapy to be covered in the home health setting, the amount,
frequency, and duration of the services must be reasonable, we propose
to revise Sec. 409.44(c)(2)(iv) to require that:
The amount, frequency and duration of therapy services
must be reasonable and necessary, as determined by a qualified
therapist and/or physician, using accepted standards of clinical
practice.
The plan of care or the functional assessment would
include any variable factors that influence the patient's condition or
affect the patient's response to treatment, especially those factors
that influence the clinician's decision to provide more services than
are typical for the patient's condition.
The clinical record documentation would have to include
objective measurements that demonstrated that the patient was making
progress toward goals. If progress could not be measured, and continued
improvement cannot be expected, therapy services would cease to be
covered, with two exceptions. First, therapy could still be considered
reasonable and necessary (and thus covered) if therapy progress
regressed or plateaued, if the reason(s) for lack of progress were
documented, and the justification supporting the expectation that
progress would be regained and maintained with continued therapy was
also documented. Second, therapy could be considered reasonable and
necessary (and thus covered) under specific circumstances when
maintenance therapy is established or provided, as explained previously
in this section.
D. Collecting Additional Claims Data for Future HH PPS Enhancements and
Soliciting Comments on HH PPS Improvements
The 2009 MedPAC report recommended that CMS improve the HH PPS to
mitigate vulnerabilities such as payment incentives to provide
unnecessary services. We believe that we need more specific resource
use data to fully address these vulnerabilities. Therefore, we are
planning to require HHAs to report additional data on the HH claim
beginning in CY 2011. Data collection requirements are handled via a
separate administrative process, and are not part of this rulemaking.
In their March 2010 report, MedPAC suggested that the HH PPS case-
mix weights needed adjustment. Our current therapy weights are
calibrated assuming that 79 percent of the time, HH therapy is provided
by therapists. We believe that the current mix of therapy services may
have changed. To ensure we accurately update the case-mix weights, we
believe there is a need to collect additional data on the HH claim to
differentiate between the therapy visits provided by therapy assistants
versus therapists.
We typically consider skilled nursing services to involve direct
skilled nursing care to a patient, and therapy services to be
restorative therapy. However, in limited situations, regulations deem a
set of nursing services which are not direct care skilled nursing as
skilled services and also deem a set of therapy services which are not
restorative therapy as skilled therapy. Therefore, we are planning to
require HHAs to report additional data on the HH claim to differentiate
between these deemed skilled services and direct care skilled nursing
or restorative therapy. We believe that these data will help us better
understand services provided, enabling us to more accurately address
overutilization vulnerabilities.
Currently, we use the following G-codes to define therapy services
in the home health setting:
G0151 Services of physical therapist in home health
setting, each 15 minutes.
G0152 Services of an occupational therapist in home health
setting, each 15 minutes.
G0153 Services of a speech-language pathologist in home
health setting, each 15 minutes.
We are planning to revise the current definitions for existing G-
codes for physical therapists (G0151), occupational therapists (G0152),
and speech-language pathologists (G0153), to include in the
descriptions that they are intended for the reporting of services
provided by a qualified physical or occupational therapist or speech-
language pathologist. A qualified therapist is one who meets the
personnel requirements in the CoPs at 42 CFR 484.4. Additionally, we
are planning to require the reporting of two additional G-codes to
report the delivery of therapy services by assistants. The following
are draft descriptions for those revised and new G-codes, for the
reporting of restorative therapy visits by qualified therapists and
qualified assistants. Since these new G-codes do not yet exist, we have
entitled all the new G-codes as G-CodeX, with the `X' being a number to
indicate which new code.
G0151 Services performed by a qualified physical therapist
in the home health setting, each 15 minutes.
G0152 Services performed by a qualified occupational
therapist in the home health setting, each 15 minutes.
G0153 Services performed by a qualified speech-language
pathologist in the home health setting, each 15 minutes.
G-Code1 Services performed by a qualified physical
therapist assistant in the home health setting, each 15 minutes.
G-Code2 Services performed by a qualified occupational
therapist assistant in the home health setting, each 15 minutes.
We are also planning to require new G-codes for the reporting of
the establishment or delivery of therapy maintenance programs by
qualified therapists. The following are draft descriptions for those
new G-codes, for the reporting of the establishment or delivery of
therapy maintenance programs by therapists:
G-Code3 Services performed by a qualified physical
therapist, in the home health setting, in the establishment or delivery
of a safe and effective therapy maintenance program, each 15 minutes.
G-Code4 Services performed by a qualified occupational
therapist, in the home health setting, in the establishment or delivery
of a safe and effective therapy maintenance program, each 15 minutes.
G-Code5 Services performed by a qualified speech-language
pathologist, in the home health setting, in the establishment or
deliver of a safe and effective therapy maintenance program, each 15
minutes.
Currently we use the following G-code for the reporting of skilled
nursing services in the home:
G0154 Skilled services of a nurse in the home health
setting, each 15 minutes.
We are planning to revise the current definition for the existing
G-code for skilled nursing services (G0154), and require HHAs to use
G0154 only for the reporting of direct skilled nursing care to the
patient by a licensed nurse. Additionally, we are planning to require
two new G-codes: One for the reporting
[[Page 43249]]
of the skilled services of a licensed nurse in the management and
evaluation of the care plan or the observation and assessment of a
patient's conditions when only the specialized skills of a licensed
nurse can determine the patient's status until the treatment regimen is
essentially stabilized; and another for the reporting of the training
or education of a patient, a patient's family, or caregiver:
G0154 Skilled services of a licensed nurse in the home
health setting, each 15 minutes.
G-Code6 Skilled services by a licensed nurse, in the
delivery of management & evaluation of the plan of care, or the
observation and assessment of the patient's condition while a patient's
treatment regime is stabilized, in the home health setting, each 15
minutes.
G-Code7 Skilled services of a licensed nurse, in the
training and/or education of a patient or family member, in the home
health setting, each 15 minutes.
In addition to our plans for collecting additional claims data for
future HH PPS enhancements, we are considering other possible changes
to the HH PPS. As such, we are also soliciting comments on options to
restructure the HH PPS to mitigate the overutilization and up-coding
risks that current data suggest. Specifically, we are soliciting
comments on possible policy options such as using the new claims data
to better account for therapy resource use and limiting the use of co-
morbid conditions in payment algorithms.
E. 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 amounts in the case of episodes that incur unusually
high costs due to patient home health care needs. Prior to the
enactment of The Affordable Care Act, this section stipulated that
total outlier payments could not exceed 5 percent of total projected or
estimated HH payments in a given year. Under the HH PPS, outlier
payments are made for episodes for which the estimated costs exceed a
threshold amount. The wage adjusted fixed dollar loss (FDL) amount
represents the amount of loss that an agency must absorb before an
episode becomes eligible for outlier payments. As outlined in our FY
2000 HH PPS final rule (65 FR 41188-41190), we provided for outlier
payments projected to not exceed 5 percent of total payments and we
adjusted the payment rates accordingly.
2. Regulatory Update
In our November 10, 2009 HH PPS final rule for CY 2010 (74 FR
58080-58087), we explained that our analysis revealed excessive growth
in outlier payments in a few discrete areas of the country. Despite
program integrity efforts associated with excessive outlier payments in
targeted areas of the country, we discovered that outlier expenditures
exceeded the 5 percent statutory limit. Consequently, we assessed the
appropriateness of taking action to curb outlier abuse.
In order to mitigate possible billing vulnerabilities associated
with excessive outlier payments, and to adhere to our statutory limit
on outlier payments, we adopted an outlier policy that included a 10
percent agency level cap on outlier payments in concert with a reduced
FDL ratio of 0.67. This resulted in a projected target outlier pool of
approximately 2.5 percent (the previous outlier pool was 5 percent of
total HH expenditures). For CY 2010, we first returned 5 percent back
into the national standardized 60-day episode rates, the national per-
visit rates, the LUPA add-on payment amount, and the NRS conversion
factor. Then we reduced the CY 2010 rates by 2.5 percent to account for
the new outlier pool of 2.5 percent. This outlier policy was adopted
for CY 2010 only.
3. Statutory Update
Section 3131(b)(1) of the The Affordable Care Act amended Section
1895(b)(3)(C), ``Adjustment for outliers''; that subparagraph now
reads, ``The Secretary shall reduce the standard prospective payment
amount (or amounts) under this paragraph applicable to home health
services furnished during a period by such proportion as will result in
an aggregate reduction in payments for the period equal to 5 percent of
the total payments estimated to be made based on the prospective
payment system under this subsection for the period.'' In addition,
Section 3131(b)(2) of The Affordable Care Act amends Section 1895(b)(5)
of the Act by taking the existing language, re-designating it as
1895(b)(5)(A) of the Act, and revising it such that it states that the
Secretary, ``may provide for an addition or adjustment to the payment
amount otherwise made in the case of outliers because of unusual
variations in the type or amount of medically necessary care. The total
amount of the additional payments or payment adjustments made under
this paragraph with respect to a fiscal year or year may not exceed 2.5
percent of the total payments projected or estimated to be made based
on the prospective payment system under this subsection in that year.''
As such, we are required to implement a HH PPS outlier policy whereby
we reduce the standard episode payment by 5 percent, and target up to
2.5 percent of total projected estimated HH PPS payments to be paid as
outlier payments. We would first return the 2.5 percent that we took
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 for CY 2010 that paid for the CY 2010 outlier pool of 2.5
percent. We will then reduce those rates by 5 percent as required by
Section 1895(b)(3)(C) of the Act as amended by Section 3131(b)(1) of
The Affordable Care Act. For CY 2011 and subsequent calendar years, the
total amount of the additional payments or payment adjustments made may
not exceed 2.5 percent of the total payments projected or estimated to
be made based on the prospective payment system in that year as
required by Section 1895(b)(5)(A) of the Act as amended by Section
3131(b)(2)(B) of The Affordable Care Act.
4. Outlier Cap
As stated earlier, for CY 2010 only, we capped home health outlier
payments at a maximum of 10 percent per agency (74 FR 58080-58087).
Section 3131(b)(2)(C) of The Affordable Care Act adds a paragraph, (B)
``Program Specific Outlier Cap'', to Section 1895(b)(5) of the Act. The
new paragraph states, ``The estimated total amount of additional
payments or payment adjustments made * * * with respect to a home
health agency for a year (beginning with 2011) may not exceed an amount
equal to 10 percent of the estimated total amount of payments made
under this section * * * with respect to the home health agency for the
year.'' Therefore, the 10 percent per agency outlier cap would continue
in CY 2011 and subsequent calendar years as required by section
1895(b)(5)(B) of the Act as amended by section 3131(b)(2)(C) of The
Affordable Care Act. Section 3131(b) requires that we (1) Reduce the
standard payment rates by 5 percent, (2) pay no more than 2.5 percent
of total estimated payments for outliers, and (3) apply a 10% agency
aggregate outlier cap.
5. Loss-Sharing Ratio and Fixed Dollar Loss Ratio
The July 2000 final rule (65 FR 41189) described a methodology for
determining outlier payments. Under this system, outlier payments are
made
[[Page 43250]]
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. With a loss-sharing ratio of 0.80, 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. 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
FDL 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
FDL 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. In the CY
2010 HH PPS final rule (74 FR 58086), we implemented a FDL ratio of
0.67.
For this proposed rule, we have updated our analysis from the CY
2010 HH PPS final rule and we estimate that maintaining a FDL ratio of
0.67, in conjunction with a 10 percent cap on outlier payments at the
agency level, would pay no more than the 2.5 percent target of outlier
payments as a percentage of total HH PPS payments as required by
Section 1895(b)(5)(A) of the Act, as amended by section 3131(b)(2)(B)
of The Affordable Care Act.
6. Solicitation of Comments Regarding Imputed Costs
The Affordable Care Act requires CMS to conduct a study which
includes analysis of ways outlier payments might be revised to reflect
costs of treating Medicare beneficiaries. CMS will produce a Report to
Congress containing this study's recommendations no later than March 1,
2014.
To consider outlier policy improvements in the nearer term we are
soliciting comments regarding alternate policy options and the
methodologies to better account for high cost patients. In particular,
we would like the industry's input on alternatives to how we impute
costs in the calculation of the outlier payments.
We have discussed and are exploring the possible use of visit
intensity data in the imputing of costs as part of the outlier payment
calculation and would be interested in the industry's views on such an
alternative. In addition, we would like to receive feedback concerning
the use of diagnoses codes (for example, diabetes) as a factor to be
used to calculate the imputed costs associated with outlier payments.
We believe that to modifying the fixed dollar loss ratio or the loss
sharing ratio, at this point in time, would not improve the current
policy, but we solicit industry comments on this as well.
F. Proposed CY 2011 Rate Update
1. Home Health Market Basket Update
Section 1895(b)(3)(B) of the Act requires for CY 2011 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. Section 3401(e) of
The Affordable Care Act amended section 1895(b)(3)(B) of the Act by
adding a new clause (vi) which states, ``After determining the home
health market basket percentage increase * * * the Secretary shall
reduce such percentage * * * for each of 2011, 2012, and 2013, by 1
percentage point. The application of this clause may result in the home
health market basket percentage increase under clause (iii) being less
than 0.0 for a year, and may result in payment rates under the system
under this subsection for a year being less than such payment rates for
the preceding year.''
The proposed HH PPS market basket update for CY 2011 is 2.4
percent. This is based on Global Insight Inc.'s first quarter 2010
forecast, utilizing historical data through the fourth quarter of 2009.
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). Due to the new requirement at section 1895(b)(3)(B)(vi) of the
Act, the proposed CY 2011 market basket update of 2.4 percent must be
reduced by 1 percentage point to 1.4 percent. In effect, the proposed
CY 2011 market basket update becomes 1.4 percent. The law does not
permit us to exercise any discretion with respect to the application of
this reduction.
2. Home Health Care Quality Improvement
a. OASIS
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 sub clause
(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 Sec. 484.225(i).
Accordingly, for CY 2011, we propose to continue to use a HHA's
submission of OASIS data to meet the requirement that the HHA submit
data appropriate for the measurement of health care quality. We are
proposing for CY 2011 to consider OASIS assessments submitted by HHAs
to CMS in compliance with HHA Conditions of Participation for episodes
beginning on or after July 1, 2009 and before July 1, 2010 as
fulfilling the quality reporting requirement for CY 2011. This time
period would allow 12 full months of
[[Page 43251]]
data collection and would provide us the time necessary to analyze and
make any necessary payment adjustments to the payment rates in CY 2011.
We propose to reconcile the OASIS submissions with claims data in order
to verify full compliance with the quality reporting requirements in CY
2011 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, agencies do not need to
submit quality data for those patients who are excluded from the OASIS
submission requirements under the Home Health Conditions of
Participation (CoP) (42 CFR 484.200 through 484.265) as well as those
excluded, as described at 70 FR 76202:
Those patients 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 receiving pre- or post-partum services, or
Those patients under the age of 18 years.
As set forth in the CY 2008 final rule at 72 FR 49863, agencies
that become Medicare certified on or after May 31 of the preceding year
(2009 for payments in 2011) are excluded from any payment penalty for
quality reporting purposes for the following CY. Therefore, HHAs that
are certified on or after May 1, 2010 are excluded from the quality
reporting requirement for CY 2011 payments. These exclusions only
affect quality reporting requirements and do not affect the HHA's
reporting responsibilities under the CoP. HHAs that meet the quality
data 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 in conjunction with applicable provisions
of The Affordable Care Act, as discussed in the section ``Proposed CY
2011 Payment Update'' of this rule.
Section 1895(b)(3)(B)(v)(III) of the Act further requires that
``[t]he Secretary shall establish procedures for making data submitted
under sub clause (II) 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.'' We propose to continue to use the subset of OASIS
data that is utilized for quality measure development and publicly
reported on Home Health Compare as the appropriate measure of home
health quality.
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 data set as described below. The Home
Health Compare Web site, which will be redesigned by October 2010, is
located at the following address: http://www.medicare.gov/HHCompare/Home.asp. Each HHA currently has pre-publication access, through the
CMS contractor, to its own quality data that the contractor updates
periodically. We propose to continue this process, to enable each
agency to view its quality measures before public posting of data on
Home Health Compare.
The following twelve outcome 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.
We propose to continue to use specified measures derived from the
OASIS data for purposes of measuring home health care quality. This
would also ensure that providers would not have an additional burden of
reporting quality of care measures through a separate mechanism, and
that the costs associated with the development and testing of a new
reporting mechanism would be avoided.
CMS proposes to change the set of OASIS outcome measures that will
be publicly reported beginning in July 2011. One new outcome measure
will be added:
Increase in number of pressure ulcers.
This outcome measure is the percentage of patient episodes in which
there was an increase in the number of unhealed pressure ulcers. This
measure is viewed as important because pressure ulcers are key
indicators of the effectiveness of care and are among the most common
causes of harm to patients. Though consensus endorsement is not a
requirement for public reporting of home health quality measures, this
measure is endorsed by the National Quality Forum.
As previously stated, although NQF endorsement is not required for
public reporting, CMS proposes to discontinue public reporting of
certain outcome measures which were previously reported on Home Health
Compare and are no longer endorsed by NQF. Those measures are--
Discharge to community,
Improvement in Urinary Incontinence, and
Emergent Care for Wound Infections, Deteriorating Wound
Status.
CMS welcomes comments regarding the public reporting of these
measures. Additionally, the change to OASIS-C results in modifications
to two of the outcome measures as shown below:
Improvement in bed transferring: This measure replaces the
previously reported measure improvement in transferring. It provides a
more focused measurement of the ability to turn and position oneself in
bed and transfer to and from the bed.
Emergency Department Use Without Hospitalization: This
measure replaces the previously reported measure: Emergent care. It
excludes emergency department visits that result in a hospital
admission because those visits are already captured in the acute care
hospitalization measure.
To summarize, we propose that the following outcome measures, which
comprise measurement of home health care quality, would be publicly
reported beginning in July 2011:
Improvement in ambulation/locomotion,
Improvement in bathing,
Improvement in bed transferring,
Improvement in management of oral medications,
Improvement in pain interfering with activity,
Acute care hospitalization,
Emergency Department Use without Hospitalization,
Improvement in dyspnea,
Improvement in status of surgical wounds,
Increase in number of pressure ulcers.
We implemented use of the OASIS-C (Form Number CMS-R-245
(OMB 0938-0760)) on January 1, 2010. This revision to OASIS
was tested and has been distributed for public comment and other
technical expert recommendations over the past few years. The OASIS-C
can be found using
[[Page 43252]]
the following link: http://www.cms.hhs.gov/HomeHealthQualityInits/12_HHQIOASISDataSet.asp#TopOfPage.
As a result of changes to the OASIS data set, process of care
measures will be available as additional measures of home health
quality. CMS published information about new process measures in the
Federal Register as a proposed rule on August 13, 2009 (74 FR 40960)
and as a final rule with comment period on November 10, 2009 (74 FR
58096). We proposed and made final the decision to update Home Health
Compare in October 2010 to reflect the addition of the following 13 new
process 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 short-term episodes of care,
Pain assessment conducted,
Pain interventions implemented during short-term episodes,
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.
The implementation of OASIS-C impacts the schedule of quality
measure reporting for CY 2010 and CY 2011. While sufficient OASIS-C
data are collected and risk models are developed, the outcome reports
(found on Home Health Compare and the contractor outcome reports used
for HHA's performance improvement activities) will remain static with
OASIS-B1 data. The last available OASIS B-1 reports will remain in the
system and on the HHC site until they are replaced with OASIS-C
reports. Sufficient numbers of patient episodes are needed in order to
report measures based on new OASIS-C data. This is important because
measures based on patient sample sizes taken over short periods of time
can be inaccurate and misleading due to issues like seasonal variation
and under-representation of long-stay home health patients. Once
sufficient OASIS-C data have been collected and submitted to the
national repository, CMS will begin producing new reports based on
OASIS-C.
December 2009 was the last month for which OBQI/M data was
calculated for OASIS B1 data and OASIS B1 OBQI/M reports will continue
to be available after March 2010. OASIS-C process measures will be
available to preview in September 2010 and will be publicly reported in
October 2010. OASIS-C outcome measures will be available to preview in
May 2011 and will be publicly reported in July 2011.
b. Home Health Care CAHPS Survey (HHCAHPS)
In the Home Health Prospective Payment System (HH PPS) Rate Update
for Calendar Year 2010 Final Rule, published on November 10, 2009, we
expanded the home health quality measures reporting requirements for
Medicare-certified agencies to include the CAHPS[reg] Home
Health Care (HHCAHPS) Survey for the CY 2012 annual payment update. CMS
is maintaining its existing policy as promulgated in the HH PPS Rate
Update for Calendar Year 2010, and is moving forward with its plans for
HHCAHPS linkage to the pay-for-reporting requirement affecting the HH
PPS rate update for CY 2012.
As part of the U.S. Department of Health and Human Services' (DHHS)
Transparency Initiative, CMS has implemented a process to measure and
publicly report patient experiences with home health care using a
survey developed by the Agency for Healthcare Research and Quality's
(AHRQ's) Consumer Assessment of Healthcare Providers and Systems
(CAHPS[reg]) program. The HHCAHPS survey is part of a family
of CAHPS[reg] surveys that asks patients to report on and
rate their experiences with health care. The HHCAHPS survey presents
home health patients with a set of standardized questions about their
home health care providers and about 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 home health agencies (HHAs).
Background and Description of the HHCAHPS
AHRQ, in collaboration with its CAHPS grantees, developed the
CAHPS[reg] Home Health Care 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 HHAs 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.
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 CAHPS[supreg] Home Health Care
Survey. We 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 received clearance from OMB on July 18, 2009, and the OMB number
is 0938-1066.
The HHCAHPS survey includes 34 questions covering 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, we will utilize composite
measures and global ratings of care. Each composite measure consists of
four or more questions regarding one of the following related topics:
1. Patient care;
2. Communications between providers and patients;
3. 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.
The survey is currently available in five languages. At the time of
the Final Rule for CY 2010, we only provided HHCAHPS in English and
Spanish translations. In the proposed rule for CY 2010, we proposed
that CMS will provide additional translations of the
[[Page 43253]]
survey over time in response to suggestions for any additional language
translations. We now offer HHCAHPS in English, Spanish, Chinese,
Russian and Vietnamese languages. We will continue to consider
additional translations of the HHCAHPS in response to the needs of the
home health patient population.
The following types of home health care patients are eligible to
participate in the HHCAHPS survey:
Current or discharged Medicare and/or Medicaid patients
who had at least one skilled home health visit at any time during the
sample month;
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 skilled care visits
from HHA personnel during a 2 month look-back period. (Note that the 2
month look-back period is defined as the 2 month 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 ``maternity'' as the primary
reason for receiving home health care; and
Patients who have not requested ``no publicity status.''
We are maintaining for the CY 2012 annual payment update the
existing requirements for Medicare-certified agencies to contract with
an approved HHCAHPS survey vendor. Beginning in summer 2009, interested
vendors applied to become approved HHCAHPS vendors. The application
process is delineated online at https://www.homehealthcahps.org.
Vendors are required to attend introductory and all update trainings
conducted by CMS and the HHCAHPS Survey Coordination Team, as well as
to pass a post-training certification test. We now have 42 approved
HHCAHPS survey vendors. In this proposed rule, we propose to codify the
requirements for HHCAHPS survey vendors for the CY 2013 annual payment
update.
HHAs started to participate in HHCAHPS on a voluntary basis
beginning in October 2009. CMS defines ``voluntary participation'' as
meaning that HHCAHPS participation is not attached to the quality
reporting requirement for the annual payment update. These agencies
selected a vendor from the list of HHCAHPS approved survey vendors.
This listing is on the Web site https://www.homehealthcahps.org.
Public Display of the Home Health Care CAHPS Survey Data
The Home Health Care CAHPS data will be incorporated into the Home
Health Compare Web site to complement the clinical measures. The
HHCAHPS data displays will be very similar to those of the Hospital
CAHPS (HCAHPS) data displays and presentations on Hospital Compare,
where the patients' perspectives of care data from HCAHPS are displayed
along with the hospital clinical measures of quality. CMS believes that
the HHCAHPS will enhance the information included in Home Health
Compare by providing Medicare beneficiaries a greater ability to
compare the quality of home health agencies. CMS anticipates that
HHCAHPS data will first be reported sometime in spring/summer 2011. The
first reporting of HHCAHPS data will include data that were collected
in the voluntary period of HHCAHPS data collection and reporting, prior
to the period when the HHCAHPS data count toward the 2012 APU.
Participation Requirements for CY 2012: The Consumer Assessment of
Healthcare Providers and Systems (CAHPS[supreg]) Home Health Care
Survey
In the HH PPS Final Rule for CY 2010, we stated that HHCAHPS would
not be required for the annual payment update for CY 2011. However, we
stated that data collection should take place beginning in CY 2010 in
order to meet the HHCAHPS reporting requirement for the CY 2012 annual
payment update as stated in the HH PPS Final Rule for CY 2010 (58078,
58099, 58100, 58103, and 58104). Medicare-certified agencies were asked
to participate in a dry run for at least one month in third quarter of
2010, and begin continuous monthly data collection in October 2010 in
accordance with the Protocols and Guidelines Manual located on the
HHCAHPS Web site https://www.homehealthcahps.org.
The dry run data should be submitted to the Home Health
CAHPS[supreg] Data Center by 11:59 p.m. EST on January 21, 2011. The
dry run data will not be publicly reported on the CMS Home Health
Compare Web site. The purpose of the dry run is to 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[supreg] Data Center. We previously stated that all
Medicare-certified HHAs should continuously collect HHCAHPS survey data
for every month in every quarter beginning with the fourth quarter
(October, November, and December) of 2010, and submit these data for
the fourth quarter of 2010 to the Home Health CAHPS[supreg] Data Center
by 11:59 p.m. EST on April 21, 2011. These data submission deadlines
are firm (that is, no late submissions will be accepted).
The period of data collection for the CY 2012 annual payment update
includes the dry run data in the third quarter 2010, the fourth quarter
2010 (October, November and December 2010), and the first quarter 2011
(January, February and March 2011). The data from the three months of
the first quarter 2011 should be submitted to the Home Health
CAHPS[supreg] Data Center by 11:59 p.m. EST on July 21, 2011. These
periods (a dry run in third quarter 2010, and six months of data from
October 2010 through March 2011) have been deliberately chosen to
comprise the HHCAHPS reporting requirements for the CY 2012 APU because
they coincide with the OASIS-C reporting requirements that are due by
June 30, 2011 for the CY 2012 APU. In the previous rule, we stated that
the HHCAHPS survey data would be submitted and analyzed quarterly, and
that the sample selection and data collection would occur on a monthly
basis. HHAs would target 300 HHCAHPS survey completes annually. Smaller
agencies that are unable to reach 300 survey completes by sampling
would survey all HHCAHPS eligible patients.
We stated that survey vendors initiate the survey for each monthly
sample within 3 weeks after the end of the sample month. We wrote that
all data collection for each monthly sample would have to be completed
within 6 weeks (42 calendar days) after data collection began. Three
survey administration modes could be used: Mail only, telephone only,
and mail with telephone follow-up (the ``mixed mode''). We also
conveyed that for mail-only and mixed-mode surveys, data collection for
a monthly sample would have to end 6 weeks after the first
questionnaire was mailed. We stated that for telephone-only surveys,
data collection would have to end 6 weeks following the first telephone
attempt. These criteria would remain the same for HHCAHPS to meet the
CY 2012 annual payment update requirements.
As stated in the Home Health Prospective Payment System Rate Update
for Calendar Year 2010; final rule (74 FR 58078), we would exempt
Medicare-certified HHAs certified on or after April 1, 2011 from the
HHCAHPS reporting requirement for CY 2012 as data submission and
analysis will not be
[[Page 43254]]
possible for an agency this late in the CY 2012 reporting period.
We would also exempt Medicare-certified agencies from the HHCAHPS
reporting requirements if they have fewer than 60 HHCAHPS eligible
unique patients from April 1, 2009 through March 31, 2010. In the CY
2010 Final Rule, we stated that by June 16, 2010, HHAs would need to
provide CMS with patient counts for the period of April 1, 2009 through
March 31, 2010. We have posted a form that the HHAs need to use to
submit their patient counts via the Web site https://www.homehealthcahps.org. This proposed requirement pertains only to
Medicare-certified HHAs with fewer than 60 HHCAHPS eligible,
unduplicated or unique patients for that time period. The
aforementioned agencies would be exempt from conducting the HHCAHPS
survey for the annual payment update in CY 2012. We propose to codify
that if an HHA has less than 60 eligible unique HHCAHPS patients
annually, then they must submit to CMS their total patient count in
order to be exempt from the HHCAHPS reporting requirement.
For CY 2012, we maintain our policy that all HHAs, unless covered
by specific exclusions, meet the quality reporting requirements or be
subject to a 2 percentage point reduction in the home health market
basket percentage increase in accordance with section
1895(b)(3)(B)(v)(I) of the Act.
A reconsiderations and appeals process is being developed for HHAs
that fail to meet the HHCAHPS reporting requirements. We proposed that
these procedures will be detailed in the CY 2012 home health payment
rule, the period for which HHCAHPS would be linked to the home health
market basket percentage increase. We propose that in September through
October 2011, we would compile a list of HHAs that were not compliant
with OASIS-C and/or HHCAHPS for the 2012 APU reporting requirements.
These HHAs would receive explicit instructions about how to prepare a
request for reconsideration of the CMS decision, and these HHAs would
have 30 days to file their requests for reconsiderations to CMS. By
December 31, 2011, we would provide our final determination for the
quality reporting requirements for calendar year 2012 payment. HHAs
have a right to appeal to the Prospective Reimbursement Review Board
(PRRB) if they are not satisfied with the CMS determination.
Oversight Activities for the Consumer Assessment of Healthcare
Providers and Systems (CAHPS[supreg]) Home Health Care Survey
We stated that vendors and HHAs would be required to participate in
HHCAHPS oversight activities to ensure compliance with HHCAHPS
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 was stated 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:
An organizational chart;
A work plan for survey implementation;
A description of survey procedures and quality controls;
Quality assurance oversight of on-site 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 and/or conference calls. The HHCAHPS
Survey Coordination Team would review the survey vendor's survey
systems, and would assess administration protocols based on the
Protocols and Guidelines Manual posted on https://www.homehealthcahps.org. We stated that all materials relevant to
survey administration would be subject to review. The 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 correct any problems and provide
follow-up documentation of corrections for review. Survey vendors would
be subject to follow-up site visits as needed.
HHCAHPS Requirements for CY 2013
For the CY 2013 annual payment update, we propose to begin to
require that four quarters of data be submitted for HHCAHPS. This would
include second quarter 2011 through first quarter 2012. We propose that
HHAs be required to submit data for the second quarter 2011 by 11:59
p.m. on October 21, 2011 to the Home Health CAHPS Data Center. We also
propose that HHAs submit data for the third quarter 2011 by 11:59 p.m.
EST January 21, 2012 to the Home Health CAHPS Data Center. We
additionally propose that HHAs be required to submit data for the
fourth quarter 2011 by 11:59 p.m. EST April 21, 2012 to the Home Health
CAHPS Data Center. Finally, we propose that HHAs be required to submit
data for the first quarter 2012 by 11:59 p.m. EST July 21, 2012 to the
Home Health CAHPS Data Center.
We propose to exempt Medicare-certified HHAs certified on or after
April 1, 2012 from the HHCAHPS reporting requirement for CY 2013, as
data submission and analysis would not be possible for an agency this
late in the CY 2013 reporting period. For the CY 2013 annual payment
update, we propose that new Medicare-certified HHAs that open during
the year begin HHCAHPS data collection the quarter following receipt of
the CMS Certification Number (CCN).
We propose that all HHAs that have fewer than 60 HHCAHPS-eligible
unduplicated or unique patients in the period of April 1, 2010 through
March 31, 2011 be exempt from the HHCAHPS data collection requirements
for the CY 2013 annual payment update. Agencies with fewer than 60
HHCAHPS-eligible, unduplicated or unique patients would be required to
submit their counts on the form posted on https://www.homehealthcahps.org, the Web site of Home Health Care CAHPS by June
16, 2011. This would be a firm deadline as are all of the quarterly
data submission deadlines.
We are proposing to codify the HHCAHPS survey vendor requirements
in the CY 2013 rule. In our regulation, we would revise Sec.
484.250(c)(2) to codify that all applying survey vendors would have to
have been in business for a minimum of three years and have conducted
surveys of individuals for at least two years immediately preceding the
application to CMS to become a survey vendor for HHCAHPS. For purposes
of the HHCAHPS, a ``survey of individuals'' would be defined as the
collection of data from individuals selected by statistical sampling
methods and the data collected are used for statistical purposes. An
applicant organization must:
Have conducted surveys of individuals responding about
their own experiences, not of individuals responding on behalf of a
business or organizations (establishment or institution surveys);
Be able to demonstrate that a statistical sampling process
(that is, simple random sampling [SRS],
[[Page 43255]]
proportionate stratified random sampling [PSRS], or disproportionate
stratified random sampling [DSRS]) was used in the conduct of
previously or currently conducted survey(s);
Be able to demonstrate that it, as an organization, has
conducted surveys where a sample of individuals was selected for at
least two years. If staff within the applicant organization has
relevant experience obtained while in the employment of a different
organization, that experience may not be counted toward the 2 year
minimum of survey experience; and
Currently possess all required facilities and systems to
implement the HHCAHPS Survey.
We are also proposing that the following examples of data
collection activities would not satisfy the requirement of valid survey
experience for vendors as defined for the HHCAHPS Survey, and these
would not be considered as part of the experience that HHCAHPS will
require:
Polling questions administered to trainees or participants
of training sessions or educational courses, seminars, or workshops;
Focus groups, cognitive interviews, or any other
qualitative data collection activities;
Surveys of fewer than 600 individuals;
Surveys conducted that did not involve using statistical
sampling methods;
Internet or Web-based surveys; and
Interactive Voice Recognition Surveys.
We are proposing to codify the criteria about which organizations
are ineligible to become HHCAHPS approved survey vendors. CMS is
proposing that any organization that owns, operates, or provides
staffing for a HHA not be permitted to administer its own Home Health
Care CAHPS (HHCAHPS) Survey or administer the survey on behalf of any
other HHA. CMS began the HHCAHPS with the belief, based on input from
many stakeholders and the public, that an independent third party (such
as a survey vendor) will be best able to solicit unbiased responses to
the HHCAHPS Survey. Since home health patients receive care in their
homes, this survey population is particularly vulnerable and dependent
upon their HHA caregivers. Therefore, in Sec. 484.250(c)(2) we are
proposing that HHAs be required to contract only with an independent,
approved HHCAHPS vendor to administer the HHCAHPS survey on their
behalf.
Specifically, we are proposing that the following types of
organizations would not be eligible to administer the HHCAHPS Survey as
an approved HHCAHPS vendor:
Organizations or divisions within organizations that own
or operate a HHA or provide home health services, even if the division
is run as a separate entity to the HHA;
Organizations that provide telehealth, monitoring of home
health patients, or teleprompting services for HHAs; and
Organizations that provide staffing to HHAs for providing
care to home health patients, whether personal care aides or skilled
services staff.
For Further Information on the HHCAHPS Survey
We encourage HHAs interested in learning about the survey 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 [email protected] for more
information.
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. We apply the appropriate wage index value to
the labor portion 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, pre-reclassified 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 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 areas without IPPS hospital
wage data are Anderson, South Carolina (CBSA 11340) and Hinesville-Fort
Stewart, Georgia (CBSA 25980).
On December 1, 2009, OMB issued Bulletin No. 10-02 located at Web
address http://www.whitehouse.gov/omb/assets/bulletins/b10-02.pdf. This
bulletin highlights three geographic areas whose principal city has
changed therefore causing the CBSA names to change and requiring new
CBSA numbers. Bradenton-Sarasota-Venice, FL (CBSA 14600) is replaced by
North Port-Bradenton-Sarasota, FL (CBSA 35840). Fort Walton Beach-
Crestview-Destin, FL (CBSA 23020) is replaced by Crestview-Fort Walton
Beach-Destin, FL (CBSA 18880). Weirton-Steubenville, WV-OH Metropolitan
Statistical Area (CBSA 48260) is replaced by Steubenville-Weirton, OH-
WV (CBSA 44600). The CBSAs and their associated wage index values are
shown in Addendum B. The wage index values for rural areas are shown in
Addendum A.
4. Proposed CY 2011 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 60-day episode rate. As set forth in Sec.
484.220, we adjust the national standardized 60-day episode rate by a
case-mix relative weight and a wage index value based on the site of
service for the beneficiary.
[[Page 43256]]
In the CY 2008 HH PPS final rule with comment period, we refined
the case-mix 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 2011 HH PPS rates use the same case-mix
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 methodology. In accordance with Sec. 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 2011, we are proposing to 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 discipline, referred to as a
LUPA. We propose to update the national per-visit rates by discipline
annually by the applicable home health market basket percentage. We
propose to adjust the national per-visit rate by the appropriate wage
index based on the site of service for the beneficiary, as set forth in
Sec. 484.230. We propose to adjust the labor portion of the updated
national per-visit rates used to calculate LUPAs by the most recent
pre-floor and pre-reclassified hospital wage index. We are also
proposing to update the LUPA add-on payment amount and the NRS
conversion factor by the proposed applicable home health market basket
update of 1.4 percent for CY 2011.
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 Sec. 484.205(b)(1) and Sec. 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 Sec. 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 case-mix 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 Sec. 484.205(c) and Sec. 484.230.
A partial episode payment adjustment as set forth in Sec.
484.205(d) and Sec. 484.235.
An outlier payment as set forth in Sec. 484.205(e) and
Sec. 484.240.
b. Proposed Updated CY 2011 National Standardized 60-Day Episode
Payment Rate
In calculating the annual update for the CY 2011 national
standardized 60-day episode payment rates, we first look at the CY 2010
rates as a starting point. The CY 2010 national standardized 60-day
episode payment rate is $2,312.94.
As previously discussed in section II.D. (``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
2011, we are proposing to return 2.5 percent back into the HH PPS
rates, to include the national standardized 60-day episode payment
rate. Therefore, to calculate the proposed CY 2011 national
standardized 60-day episode payment rate, we first increase the CY 2010
national standardized 60-day episode payment rate ($2,312.94) to adjust
for the 2.5 percent set aside in CY 2010 for outlier payments. We then
reduce that adjusted payment amount by 5 percent, for outlier payments
as a percentage of total HH PPS payment as mandated by Section 3131 of
The Affordable Care Act. Next, we update the payment amount by the
current proposed CY 2011 home health market basket update of 1.4
percent.
As previously discussed in Section II.A. (``Case-Mix Measurement
Analysis'') of this proposed rule, our updated analysis of the change
in case-mix that is not due to an underlying change in patient health
status reveals additional increase in nominal change in case-mix.
Therefore, we propose to reduce rates by 3.79 percent in CY 2011,
resulting in a proposed updated CY 2011 national standardized 60-day
episode payment rate of $2,198.58. The proposed updated CY 2011
national standardized 60-day episode payment rate for an HHA that
submits the required quality data is shown in Table 4. The proposed
updated CY 2011 national standardized 60-day episode payment rate for
an HHA that does not submit the required quality data (home health
market basket update of 1.4 percent is reduced by 2 percentage points)
is shown in Table 5.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
[[Page 43258]]
c. Proposed National Per-Visit Rates Used To Pay LUPAs and Compute
Imputed Costs Used in Outlier Calculations
In calculating the proposed CY 2011 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 2010 national per-
visit rates. We first adjust the CY 2010 national per-visit rates to
adjust for the 2.5 percent set aside during CY 2011 for outlier
payments. We then reduce those national per-visit rates by 5 percent as
mandated by section 1895(b)(3)(C) of the Act, as amended by Section
3131 of The Affordable Care Act. Next we update the national per-visit
rates by the current proposed CY 2011 home health market basket update
of 1.4 percent. National per-visit rates are not subject to the 3.79
percent reduction related to the nominal increase in case-mix. The
proposed CY 2011 national per-visit rates per discipline are shown in
Table 6. 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
Pathology Therapy (SLP).
BILLING CODE 4120-01-P
[[Page 43259]]
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BILLING CODE 4120-01-C
[[Page 43260]]
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 returning 2.5
percent back into the LUPA add-on payment. We then reduce the LUPA add-
on payment by 5 percent outlier adjustment as mandated by Section
1895(b)(3)(C) of the Act as amended by Section 3131 of The Affordable
Care Act. Next we update the LUPA payment amount by the current
proposed CY 2011 home health market basket update percentage of 1.4
percent. The LUPA add-on payment amount is not subject to the 3.79
percent reduction related to the nominal increase in case-mix. For CY
2011, we propose that the add-on to the LUPA payment to HHAs that
submit the required quality data would be updated by the proposed home
health market basket update of 1.4 percent. The proposed CY 2011 LUPA
add-on payment amount is shown in Table 7 below. 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
(1.4 percent) minus two percentage points.
[GRAPHIC] [TIFF OMITTED] TP23JY10.007
e. 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 2010 NRS conversion
factor ($53.34) for the 2.5 percent set aside for outlier payments in
CY 2010. We then reduce that amount by the 5 percent outlier adjustment
as mandated by Section 1895(b)(3)(C), as amended by Section 3131 of The
Affordable Care Act. Next we update by the proposed market basket
update of 1.4 percent. Finally, we then reduce that adjusted payment
amount by 3.79 percent to account for the increase in nominal case-mix.
The final updated CY 2011 NRS conversion factor for CY 2011 in Table 8a
below. For CY 2011, the proposed NRS conversion factor is $50.70.
[GRAPHIC] [TIFF OMITTED] TP23JY10.008
Using the proposed NRS conversion factor ($50.70) for CY 2011, the
payment amounts for the various severity levels are shown in Table 8b.
[[Page 43261]]
[GRAPHIC] [TIFF OMITTED] TP23JY10.044
For HHAs that do not submit the required quality data, we again
begin with the CY 2010 NRS conversion factor. We first adjust the CY
2010 NRS conversion factor ($53.34) for the 2.5 percent set aside for
outlier payments in CY 2010. We then reduce that amount by the 5
percent outlier adjustment as mandated by Section 1895(b)(3)(C) of the
Act, as amended by Section 3131 of The Affordable Care Act. Next we
update the conversion factor by the proposed CY 2011 home health market
basket update percentage of 1.4 percent minus 2 percentage points.
Finally, we reduce that adjusted payment amount by 3.79 percent to
account for the increase in nominal case-mix. The proposed CY 2011 NRS
conversion factor for HHAs that do not submit quality data is shown in
Table 9a below.
[GRAPHIC] [TIFF OMITTED] TP23JY10.009
The payment amounts for the various severity levels based on the
updated conversion factor for HHAs that do not submit quality data are
calculated in Table 9b below.
[GRAPHIC] [TIFF OMITTED] TP23JY10.010
[[Page 43262]]
5. Rural Add-On
Section 3131(c) of The Affordable Care Act amended section 421(a)
of the Medicare Prescription Drug, Improvement, and Modernization Act
(MMA) of 2003 (Pub. L. 108-173) as amended by section 5201(b) of the
Deficit Reduction Act of 2005 (Pub. L. 109-171). The amended section
421(a) of the MMA provides an increase of 3 percent of the payment
amount otherwise made under section 1895 of the Act for home health
services furnished in a rural area (as defined in section 1886(d)(2)(D)
of the Act), with respect to episodes and visits ending on or after
April 1, 2010 and before January 1, 2016. The statute waives budget
neutrality related to this provision as it specifically states that the
Secretary shall not reduce the standard prospective payment amount (or
amounts) under section 1895 of the Act applicable to home health
services furnished during a period to offset the increase in payments
resulting in the application of this section of the statute. The 3
percent rural add-on is applied to the national standardized 60-day
episode rate, national per-visit rates, LUPA add-on payment, and NRS
conversion factor when home health services are provided in rural (non-
CBSA) areas. We implemented this provision for CY 2010, for episodes
and visits ending on or after April 1, 2010 and ending before January
1, 2011 through Program Memorandum ``Temporary 3 Percent Rural Add-On
for the Home Health Prospective payment System (HH PPS)'' (Transmittal
674/Change Request 6955, issued April 23, 2010).
Refer to Tables 10 thru 13b below for these payment rates.
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[[Page 43263]]
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[[Page 43264]]
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G. Enrollment Provisions for HHAs
1. HHA Capitalization
On January 5, 1998, we published a final rule in the Federal
Register (63 FR 291) requiring newly-enrolling HHAs to submit proof
that they have available sufficient funds--or ``initial reserve
operating funds'' (IROF)--to operate the HHA for the three-month period
after its provider agreement becomes effective (exclusive of actual or
projected accounts receivable from Medicare and other health insurers).
This rule, which added a new section 42 CFR 489.28, was prompted by our
concerns about underfunded HHAs entering the Medicare program. We
elaborated on this point in the preamble to the final rule (63 FR 291,
at 295 (Jan. 5, 1998)):
New HHAs generally are small businesses and have the same need
for adequate capitalization as have other small businesses which are
just starting. As with other small businesses, a lack of funds in
reserve to operate the business until a stream of revenues can be
established can seriously threaten the viability of the business. In
addition, for new HHAs, which are in business to render patient care
services, any condition threatening the viability of the new
business can adversely affect the quality of care to their patients
and, in turn, the health and safety of those patients. That is, if
lack of funds forces an HHA to close its business, to reduce staff,
or to skimp on patient care services because it lacks sufficient
capital to pay for the services, the overall well-being of the HHA's
patients could be compromised. In fact, there could be the risk of
serious ill effects as a result of patients not receiving adequate
services.
The level of services provided to an HHA's patients is of
serious concern to us for the following reason. The process by which
an HHA participates in the Medicare program is one that involves a
survey by us or an accrediting organization. This survey is
essentially a snapshot of the agency's activities. For a new agency
that is undercapitalized, it may be unable to sustain the level of
services it is able to provide at the time of the survey over the
period of time necessary for it to begin receiving a steady stream
of revenue from Medicare. The period in question could last as long
as two or even three months. Since a survey has already been
conducted, the new HHA's services are not routinely inspected during
this period and so there is increased danger that lack of operating
funds could result in inadequate care that is not discovered.
The preamble also cited a 1997 OIG report entitled: ``Home Health:
Problem Providers and their Impact on Medicare'' (OEI-09-96-00110), in
which the OIG expressed similar worries about undercapitalized HHAs.
The OIG stated:
If it were not for Medicare accounts receivable, problem
agencies would have almost nothing to report as assets. Agencies
tend to lease their office space, equipment, and vehicles. They are
not required by Medicare to own anything, and they are almost always
undercapitalized. On average, cash on hand and fixed assets amount
to only one-fourth of total assets for HHAs, while Medicare accounts
receivable frequently equal 100 percent of total assets. These
agencies are almost totally dependent on Medicare to pay their
salaries and other operating expenses. For a home health agency,
there are virtually no startup or capitalization requirements. In
many instances, the problem agencies lease everything without
collateral. They do not even have enough cash on hand to meet their
first payroll.
Medicare contractors have been carrying out the provisions of 42
CFR 489.28 since their enactment in 1998. Traditionally, the contractor
has determined the provider's compliance with 489.28 prior to making
its recommendation for approval to the State Agency and the CMS
Regional Office (RO), which can occur several months or more before the
actual provider agreement is signed by a prospective home health
agency. We have worked to ensure that our contractors are consistently
applying its capitalization regulations found in 42 CFR 489.28(a) which
states,
An HHA entering the Medicare program on or after January 1,1998,
including a new HHA as a result of a change of ownership, if the
change of ownership results in a new provider number being issued,
must have available sufficient funds, which we term ``initial
reserve operating funds,'' to operate the HHA for the three month
period after its Medicare provider agreement becomes effective,
exclusive of actual or projected accounts receivable from Medicare
or other health care insurers.
Verifying the capitalization amount at various points in the
enrollment process
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can help CMS ensure that a prospective home health agency will have
sufficient funds to operate prior to receiving approval from CMS that
it is approved to participate in the Medicare program and has been
conferred Medicare billing privileges. In addition, confirming
capitalization more than one time during the process would address our
concern that a provider that may have redirected these funds--which had
originally been secured exclusively to meet the capitalization
requirements--for a purpose other than to operate the business. Indeed,
situations have arisen in which the HHA no longer has sufficient
capitalization at the time it signs its Medicare provider agreement.
This circumstance completely defeats the policy behind Sec. 489.28
which is to ensure that an HHA is adequately capitalized when it
becomes a Medicare provider. Accordingly, we believe that a prospective
HHA must meet and maintain adequate capitalization during the entire
period between when it first submits its enrollment application to the
Medicare contractor and when the contractor conveys Medicare billing
privileges to the HHA. This will ensure that the home health agency has
sufficient operating funds at the time of application submission,
during the period in which a State Agency or deemed accrediting
organization is ensuring that the HHA meets the Conditions of
Participation, prior to the issuance of a provider agreement and the
conveyance of Medicare billing privileges.
To that end, we propose to require a prospective HHA to meet the
capitalization requirements from the time of application submission
through three months past the conveyance of Medicare billing privileges
by the Medicare contractor. Further, CMS and/or its Medicare contractor
must be able to verify an applicant's capitalization data at any time
prior to the point at which the Medicare contractor conveys billing
privileges to the HHA as well as three months thereafter. Accordingly,
we are proposing that a prospective HHA be required to submit
verification of compliance with Sec. 489.28: (1) At the time of
application submission, (2) during the period in which a State Agency
or CMS-approved accreditation organization is making a determination as
to whether the provider is in compliance with the Conditions of
Participation; and (3) within the three months immediately following
the issuance of a Medicare billing privileges. And while we believe
that a prospective HHA should submit verification of compliance with
Sec. 489.28 within 30 days of a Medicare contractor's request, we
believe that the Medicare contractor should have the ability to request
and verify that an HHA continues to meet the capitalization
requirements. This final step is especially important, because it would
allow CMS to verify that the HHA actually had--rather than simply
projecting to have had--adequate funds during the three-month period
following issuance of Medicare billing privileges.
We believe that a Medicare contractor should verify that the
prospective HHA is in compliance with all enrollment requirements when
an enrollment application is submitted, during the period in which it
is undergoing a State survey or accreditation review to determine
compliance with the HHA Conditions of Participation, and before and
after the issuance of Medicare billing privileges and within three
months thereafter. Moreover, if a prospective HHA is determined to be
out of compliance with Medicare enrollment requirements, including not
meeting capitalization requirements at any time prior to the issuance
of Medicare billing privileges, we believe that the Medicare contractor
may deny such privileges using the specific denial reason for failing
to meet this requirement which can be found in 42 CFR 424.530(a)(8) and
afford the HHA with applicable Medicare appeal rights pursuant to part
498. Finally, we believe if an enrolled HHA is determined to be out of
compliance with the capitalization requirements within three months
after we have conveyed Medicare billing privileges, then that the
Medicare contractor can revoke Medicare billing privileges using the
specific revocation reason for failing to meet this requirement which
can be found in Sec. 424.535(a)(11) and afford the HHA with applicable
Medicare appeal rights.
Accordingly, we are proposing to revise Sec. 489.28(a) to include
additional capitalization verification by us or its Medicare contractor
during the enrollment process. Specifically, we are proposing to revise
Sec. 489.28(a) to read as set out in the regulatory text of this
proposed rule.
Since it is not possible for the Medicare program to assess whether
a prospective HHA is receiving reimbursement for other health care
insurers, we are proposing to remove, ``or other health care
insurers.'' from Sec. 489.28(a). In addition, we do not believe that
it is necessary to require HHAs to project the number of visits within
the initial three month operating period because there are incentives
for prospective HHAs to under report the number of visits in order to
reduce the capitalization amount. Accordingly, rather than accepting
the number of site visits furnished by a prospective HHA as the basis
for capitalization amount, we believe that it would be more appropriate
to compare a prospective HHA with similarly situated HHAs that are
already enrolled in the Medicare program. Sections Sec. 1815(a),
1833(e), and 1861(v)(1)(A) of the Act require that providers of
services participating in the Medicare program submit annual
information to achieve settlement of costs for health care services
rendered to Medicare beneficiaries. Also, 42 CFR 413.20 requires cost
reports from providers on an annual basis. In accordance with these
provisions, all home health agencies (HHAs) must complete Form HCFA-
1728-94, which provides data used by the fiscal intermediaries in
determining program reimbursement.
We believe that this change will deter or limit the number of
undercapitalized individuals and organizations from seeking to enroll
in the Medicare program. In addition, we believe that this change will
help to ensure that prospective HHAs establish and maintain the amount
of capital to furnish quality services to eligible beneficiaries
without reimbursement from the Medicare program during the first three
months of operations.
In Sec. 489.28(c), we propose to add a new paragraph (1) to
emphasize that the Medicare contractor, in selecting comparative HHAs
for the purpose of calculating the enrolling HHA's required level of
capitalization, shall only select HHAs that have submitted cost reports
to Medicare. By reviewing the cost report, a Medicare contractor can
audit costs and reimbursements. Medicare contractors have been
selecting comparable HHAs using this methodology for purposes of the
current requirement, but we believe that the current language in
paragraph (c) should be clarified.
In 489.28(g), we propose to amend this provision to establish that
CMS will only convey Medicare billing privileges to an HHA that
satisfies its initial reserve operating funds requirement.
In 42 CFR 424.510, we propose to add meeting the initial reserve
operating funds requirement found in Sec. 489.28(a) as an enrollment
requirement for prospective home health providers.
In 42 CFR 424.530(a)(8), we propose to deny Medicare billing
privileges to a prospective HHA if they cannot furnish supporting
documentation within 30 days of a contractor request that verifies that
the HHA meets the initial reserve operating funds requirement found in
[[Page 43266]]
42 CFR 489.28(a). In addition, we propose to deny Medicare billing
privileges to a prospective home health provider that fails to meet the
initial reserve operating funds requirement found in 489.28(a).
Similarly, at 42 CFR 424.535(a)(8), we propose to revoke Medicare
billing privileges and the corresponding provider agreement if the
enrolled HHA is not able to furnish supporting documentation within 30
days of a contractor request that verifies that the HHA meets the
initial reserve operating funds requirement found in 42 CFR 489.28(a).
2. Change of Ownership
In last year's home health prospective payment system final rule
titled, ``Medicare Program: Home Health Prospective Payment System Rate
Update for Calendar Year 2010,'' we finalized several home health
program integrity provisions. Specifically, we finalized a provision in
42 CFR 424.550(b)(1) stating that if an owner of an HHA 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 Sec. 424.510, and (ii)
Obtain a State survey or an accreditation from an approved
accreditation organization.
We received several comments supporting the establishment of the
36-month provision and did not receive any specific recommendations
that we establish exceptions to the implementation of this provision.
However, since the implementation of 42 CFR 424.550(b)(1) in
January 2010, we have received a number of comments regarding the
impact of this provision on bona fide ownership transactions.
Accordingly, we are proposing exemptions to the 36-month provision for
certain legitimate transactions related to HHAs. In particular, we are
proposing to revise 42 CFR 424.550(b) by adding subparagraph (2) as
exemptions to 42 CFR 424.550(b)(1):
A publicly-traded company is acquiring another HHA and
both entities have submitted cost reports to Medicare for the previous
five (5) years.
An HHA parent company is undergoing an internal corporate
restructuring, such as a merger or consolidation, and the HHA has
submitted a cost report to Medicare for the previous five (5) years.
The owners of an existing HHA decide to change the
existing business structure (e.g., partnership to a limited liability
corporation or sole proprietorship to subchapter S corporation), the
individual owners remain the same, and there is no change in majority
ownership (i.e., 50 percent or more ownership in the HHA.)
The death of an owner who owns 49 percent or less (where
several individuals and/or organizations are co-owners of an HHA and
one of the owners dies) interest in an HHA.
It is important to note that while we are proposing the
aforementioned exceptions, we remain concerned that a significant
number of HHAs have--and will continue to attempt to--participate in a
practice often referred to as a ``certificate mill.'' Under this
scenario, which we addressed in the 2010 HH PPS rule, entrepreneurs
apply for Medicare certification, undergo a survey, and, become
enrolled in Medicare, but then immediately sell the agency without
having seen a single Medicare beneficiary or hired a single employee.
These brokers, in other words, enroll in Medicare exclusively to sell
the HHA, rather than to provide services to beneficiaries. This
practice allows a purchaser of an HHA from the broker to enter the
Medicare program without having to undergo a State survey, which, in
turn, often leads to that owner selling the business very soon
thereafter to someone else. The ``flipping'' mechanism is used to
circumvent the State survey process. It is for this reason, that we
maintain that 42 CFR 424.550(b)(1) is necessary to eliminate the
``certificate mill'' process. 3.
3. Change in Majority Ownership Within 36 Months of Initial Enrollment
or Change in Ownership
Section 1124 of the Social Security Act requires that: (1) All
persons and organizations with a 5 percent or greater ownership
interest in the provider, and (2) all partners in a partnership (if, of
course, the provider is established as a partnership), be reported to
us. Accordingly, we believe that HHAs and other provider organizations
must report a change of ownership of 5 percent of more of the equity in
the company.
However, we recognize that in many cases a small change in
ownership (e.g., 5 percent) does not result in fundamental change of
ownership by the majority owner or owner(s) and should not necessarily
require a new enrollment and State survey or meet the deemed-
accreditation status. However, we are concerned that prospective HHA
owners can circumvent the spirit and intent of Sec. 424.550(b)(1) by
incrementally increasing their level of ownership to the point where
they could effectively assume 51 percent or more ownership of an HHA
without having to enroll as a new provider or undergo a State survey or
obtain deemed accreditation status by a CMS-approved accreditation
organization. For instance, an owner, with a 30 percent ownership
interest could purchase an additional 20 percent, plus one (1) share
stake in the company by submitting four separate changes of information
to the Medicare contractor. The end result is that the HHA would then
be owned by an individual or organization for whom--because of his or
her ability to avoid having to undergo a State survey or obtain
accreditation due to his or her incremental purchases--we cannot
determine their commitment to furnishing quality services to Medicare
beneficiaries.
Accordingly, in Sec. 424.550(a)(1) we are proposing that any
change in majority control and/or ownership during the first 36 months
of when the HHA is initially conveyed Medicare billing privileges or
the last change of ownership (including asset sale, stock transfer,
merger or consolidation) would trigger the provisions of Sec.
424.550(b)(1). We believe that this approach would allow individuals or
organizations to purchase or sell an ownership interest in an HHA as
long as it did not change majority ownership or control within the
first 36 months of ownership.
Consequently, we are proposing a definition of ``Change in Majority
Ownership'' to mean an individual or organization acquires more than 50
percent interest in an HHA during the 36 following the initial
enrollment into the Medicare program or a change of ownership
(including asset sale, stock transfer, merger, or consolidation). This
includes an individual or organization that acquires majority ownership
in an HHA through the cumulative effect of asset sales, stock
transfers, consolidations, and/or mergers during a 36-month period.
H. Home Health Face-to-Face Encounter
Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act require a plan
of care for furnishing home health services be established and
periodically reviewed by a physician in order for Medicare payments for
those services to be made. The physician is responsible for certifying
that the individual is confined to his or her home and needs skilled
nursing care on an intermittent basis or physical or speech therapy.
The
[[Page 43267]]
plan for furnishing such services has to be established, and updated
when appropriate, by the beneficiary's physician.
In recent years MedPAC has reported that the Medicare eligibility
criteria for the home health benefit are broad and open to different
interpretations by clinicians. See Report to the Congress: Medicare
Payment Policy (March 2004). The 2010 MedPAC report continues to cite
the complexity of Medicare's requirements for home health eligibility,
and recommends that physicians may benefit from the information gained
by an in-person examination. MedPAC further states that ``establishing
clear expectations for the purpose of these examinations would be
critical to ensuring their effectiveness'' [MedPAC report dated March
2010, p. 216].
On March 23, 2010, the Patient Protection and Affordable Care Act
(The Affordable Care Act) of 2010 (Pub. L. 111-148) was enacted.
Section 6407(a) (amended by section 10605) of The Affordable Care Act
amends the requirements for physician certification of home health
services contained in Sections 1814(a)(2)(C) and 1835(a)(2)(A) by
requiring that, prior to making such certification, the physician must
document that the physician himself or herself or specified non-
physician practitioner has had a face-to-face encounter (including
through the use of telehealth, subject to the requirements in section
1834(m) of the Act), with the patient incident to the services
involved.
The Affordable Care Act describes non-physician practitioners who
may perform this face-to-face patient encounter as a nurse practitioner
or clinical nurse specialist (as those terms are defined in section
1861(aa)(5) of the Act), who is working in collaboration with the
physician in accordance with State law, or a certified nurse-midwife
(as defined in section 1861(gg) of the Act, as authorized by State
law), or a physician assistant (as defined in section 1861(aa)(5) of
the Act), in accordance with State law and under the supervision of the
physician. The Affordable Care Act provision does not amend the
statutory requirement that a physician must certify a patient's
eligibility for Medicare's home health benefit. Rather the provision
allows for specific non-physician practitioners to perform the face-to-
face encounter with the patient in lieu of the certifying physician,
and inform the physician making the initial certification for
eligibility for the Medicare home health benefit. The certifying
physician must document the face-to-face encounter regardless of
whether the physician himself or herself or one of the permitted non-
physician practitioners perform the face-to-face encounter. The
Affordable Care Act gives the Secretary the discretion to set a
reasonable timeframe for this encounter.
We believe that the face-to-face encounter statutory provision was
enacted to strengthen physician accountability in certifying that home
health patients meet home health eligibility requirements. We also
believe that in order to achieve this goal, the encounter must occur
close enough to the home health start of care to ensure that the
clinical conditions exhibited by the patient during the encounter are
related to the primary reason for the patient's need for home health
care. As such, we believe that encounters would need to occur closer to
the start of home health care than the six month period prior to
certification recommended, but not required by The Affordable Care Act
for Part B services. Therefore we propose revising Sec.
424.22(a)(1)(v) such that for initial certifications, prior to a
physician signing that certification and thus certifying a patient's
eligibility for the Medicare home health benefit, the physician
responsible for certifying the patient for home health services must
document that a face-to-face patient encounter (including through the
use of telehealth if appropriate) has occurred no more than 30 days
prior to the home health start-of-care date by himself or herself, or
by an authorized non-physician practitioner (as specified in sections
1814(a)(2)(C) and 1835(a)(2)(A) of the Act) working in collaboration
with or under the supervision of the certifying physician as described
above.
We believe that in many cases, a face-to-face encounter with a
patient within the 30 days prior to the home health episode start of
care will provide the certifying physician a current clinical
presentation of the patient's condition such that the physician can
accurately certify home health eligibility, and in conjunction with the
home health agency, can establish an effective care plan. We also
believe that a face-to-face encounter which occurs within 30 days prior
to the home health start of care would be generally relevant to the
reason for the patient's need for home health services, and therefore
such a face-to-face would be sufficient to meet the goals of this
statutory requirement. However, if a face-to-face encounter occurs
within 30 days of the start of the home health episode, but the
clinical condition of the patient changes significantly between the
time of the face-to-face encounter and the home health episode of care
such that the primary reason the patient requires home health care is
unrelated to the patient's condition at the time of the face-to-face
encounter, this encounter would not satisfy the requirement. Rather, in
this case, we propose revising Sec. 424.22(a)(1)(v)(B) such that the
certifying physician, or authorized non-physician practitioner, must
have another face-to-face encounter (which may include the use of
telehealth, subject to the requirements in section 1834(m) of the Act
and subject to the list of Medicare telehealth services established in
the most recent year's physician fee schedule regulations) with the
patient within two weeks after the start of the home health episode.
The certifying physician must document the face-to-face encounter,
along with the clinical findings of that encounter as part of the
signed and dated certification. This documentation must be clearly
titled, dated, and signed by the certifying physician. Because the
patient's clinical condition significantly changed, we believe that a
more contemporaneous visit is needed to ensure the certifying physician
can accurately certify the patient's eligibility for services, and
effectively plan the patient's care.
Similarly, we propose to revise Sec. 424.22(a)(1)(v)(B) to reflect
that if a home health patient has not seen the certifying physician or
one of the specified non-physician practitioners as described above, in
the 30 days prior to the home health episode start of care, the
certifying physician or non-physician practitioner, would be required
to have a face-to-face encounter (including the use of telehealth,
subject to the requirements in section 1834(m) of the Act and subject
to the list of Medicare telehealth services established in the most
recent year's physician fee schedule regulations) with the patient
within two weeks after the start of the home health episode to comply
with the requirements for payment under the Medicare Program.
We also propose to revise Sec. 424.22(a)(1)(v) so that the
certifying physician's documentation of the face-to-face encounter
would clearly state that either the certifying physician himself or
herself, or the applicable non-physician practitioner has had a face-
to-face encounter with the patient and would include the date of that
encounter. The documentation would also describe how the clinical
findings of that encounter supported the patient's eligibility for the
Medicare home health benefit. Specifically, the physician would
document how the clinical findings of the encounter supported findings
that the patient was homebound and in need of intermittent
[[Page 43268]]
skilled nursing and/or therapy services, as defined in Sec. 409.42(a)
and Sec. 409.42(c) respectively. The certifying physician would be
required to sign and date the documentation entry into the
certification and document the face-to-face encounter in his/her
practice's medical record. As such the physician's medical keeping for
that patient must be consistent with, and supportive of, the required
documentation of the face-to-face encounter as part of the
certification.
Again, the certifying physician's documentation of the face-to-face
patient encounter would be either a separate and distinct area on the
certification or a separate and distinct addendum to the certification
that was easily identifiable and clearly titled.
If an allowed non-physician practitioner was conducting the face-
to-face visit, that practitioner would have to document the clinical
findings of the face-to-face patient encounter and communicate those
findings to the certifying physician, so that the certifying physician
could document the face-to-face encounter accordingly, as part of the
signed certification. Section 409.41 of the CFR states that in order
for home health services to qualify for payment under the Medicare
program the physician certification requirements for home health
services must be met in compliance with Sec. 424.22. Therefore, if the
patient's certifying physician did not document that a face-to-face
encounter occurred no more than 30 days prior to the home health start
of care date or two weeks after the start of care date, the services
would not qualify for payment under the Medicare program.
Additionally our regulations at Sec. 424.22 require a physician's
signature for certification and recertification of the need for home
health care. To strengthen our regulations to mirror our longstanding
manual policy and to achieve consistency with the proposed timing and
documentation of the face-to-face encounter, we propose to revise our
certification and recertification requirements at Sec. 424.22 to
require that these documents must include the date and signature of the
physician.
As defined in 42 CFR 411.354, certifying physicians are not
permitted to have a financial relationship with the HHA, unless one of
the exceptions in section 1877 of the Act is met. Similarly, we would
preclude non-physician practitioners from performing a face-to-face
encounter for the purpose of informing the certifying physician, as
described in sections 1814 and 1835 of the Act, if the non-physician
practitioner was an employee of the HHA. We propose to apply this
prohibition by revising Sec. 424.22(d) to not allow non-physician
practitioners to perform a face-to-face encounter, if employed by the
HHA, as defined by Section 210(j) of the Act.
When a physician is certifying a patient for home health services,
the physician is certifying that the patient is confined to his home
and in need of intermittent skilled nursing or therapy services.
Therefore, physicians must utilize their intimate knowledge of the
patient's medical condition to determine the patient's health care
needs. We believe that physician involvement is very important in
maintaining quality of care under the Medicare home health benefit and
ensure appropriate use of the benefit. Thus, the fundamental goals of
physician certification are strengthened by the new requirement for a
face-to-face patient encounter.
As such, we are proposing to revise 42 CFR 424.22(a)(1) by adding
language to set timing requirements for the face-to-face patient
encounter, to ensure that the face-to-face patient encounter is related
to the primary reason the patient requires home health services, and to
set encounter documentation requirements. We are also proposing that
non-physician practitioners be precluded from performing a face-to-face
encounter for the purpose of informing the certifying physician, as
described in sections 1814 and 1835 of the Act, if the non-physician
practitioner is an employee of the HHA, as defined by Section 210(j) of
the Act.
We propose implementing the above face-to-face patient encounters
provisions as they relate to home health episodes beginning 1/1/2011
and later.
I. Solicitation of Comments: Future Plans to Group HH PPS Claims
Centrally During Claims Processing
Generally speaking, Medicare makes payment under the HH PPS on the
basis of a national standardized 60-day episode payment rate that is
adjusted for case-mix and geographic wage variations. The national
standardized 60-day episode payment rate includes the six home health
disciplines (skilled nursing, home health aide, physical therapy,
speech language pathology, occupational therapy, and medical social
services) and non-routine medical supplies. Durable medical equipment
covered under home health 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 Outcome &
Assessment Information Set (OASIS) instrument. On Medicare claims, the
HHRGs are represented as Health Insurance Prospective Payment System
(HIPPS) codes.
At a patient's start of care, and at the start of each subsequent
60 day episode, and when a patient's condition changes significantly,
the HHA is required to perform a comprehensive clinical assessment of
the patient and complete the OASIS assessment instrument. The OASIS
instrument collects data concerning 3 dimensions of the patient's
condition: (1) Clinical severity (orthopedic, neurological or diabetic
conditions, etc.), (2) Functional status (comprised of 6 activities of
daily living {ADL{time} ), and (3) Service utilization (therapy visits
provided during episode). HHAs enter data collected from their
patients' OASIS assessments into a data collection software tool. For
Medicare patients, the data collection software invokes HH PPS Grouper
software to assign a HIPPS code to the patient's OASIS assessment. The
HHA includes this HIPPS code on the Medicare HH PPS bill, ultimately
enabling CMS' claims processing system to reimburse the HHA for
services provided to patients receiving Medicare's home health benefit.
Additionally, the HHA is required to electronically submit OASIS
assessments for their Medicare and Medicaid patients to CMS via their
State agency. On the HH PPS public Web site at http://www.cms.gov/homehealthpps/01_overview.asp, CMS provides a free OASIS assessment
data collection tool (HAVEN) which includes the HH PPS grouper
software, a separate HH PPS grouper program which can be incorporated
into an HHA's own data collection software, and HH PPS data
specifications for use by HHAs or software vendors desiring to build
their own HH PPS grouper. Most HHAs do not use the HAVEN freeware,
instead preferring to employ software vendors to create and maintain a
customized assessment data collection tool which can be integrated into
the HHA's billing software. Likewise, many vendors employed by HHAs do
not utilize the HH PPS grouper freeware, instead preferring to build
their own HH PPS grouper from the data specifications which CMS
provides.
In 2008, CMS deployed the first refinements to the HH PPS since its
inception in 2000. Prior to the 2008 refinements, CMS made infrequent,
minor changes to the HH PPS grouper software. Effective with the
refinements, the HH PPS grouper became more
[[Page 43269]]
complex and more sensitive to the yearly ICD-9-CM code changes. As a
result, since 2008 HHAs have been required to update their HH PPS
grouper software at least once each year. Most HHAs employ software
vendors to effectuate these updates. HHAs have expressed concerns to
CMS that the frequent grouper updates coupled with the additional
complexity of the grouper has resulted in unexpected costs and an
increased burden to them.
Also, since the 2008 refinements were implemented, CMS has
identified a significant increase in OASIS assessments submitted with
erroneous HIPPS codes. These errors occur when HHAs and/or their
software vendors inaccurately replicate the HH PPS grouper algorithm
into the HHA's customized software. The significant increase in these
errors since 2008 suggests that many HHA software vendors are
struggling to accurately replicate the complex algorithms in the HH PPS
grouper. CMS informs HHAs when the submitted HIPPS on the OASIS is
inaccurate and provides HHAs with the correct HIPPS to enable the HHA
to accurately bill Medicare. However, HHAs have expressed concerns that
the HH PPS grouper complexities increase their vulnerability to submit
an inaccurate HIPPS code on the Medicare bill. Further, some HHAs have
expressed concern that this vulnerability will further increase when
CMS begins requiring use of ICD-10-CM codes instead of ICD-9-CM codes
because the ICD-10-CM migration will require major changes to an
already complex HH PPS grouper.
Because of these concerns, we have begun analyzing options to
streamline the process which assigns HIPPS codes. We are analyzing
options which would enable CMS to assign HIPPS codes to the HH PPS
bills during claims processing. If we were successful in implementing
this option, OASIS assessment data collection tools would no longer
invoke HH PPS grouper software to assign HIPPS codes to the OASIS
assessments. Further, HHAs would no longer be required to include HIPPS
codes on HH PPS bills. Such a process would relieve the HHA of all
responsibility associated with the HH PPS grouper. If we can centralize
the assignment of the HIPPS code to the HH PPS bill during claims
processing, we will achieve process efficiencies, improve payment
accuracy by improving the accuracy of the bill's HIPPS code, decrease
costs and burden to HHAs, while also better position HHAs and CMS for
an easier transition from ICD-9 to ICD-10 codes in the future.
Several changes have occurred recently that allow us to consider
this option. National claims coding standards have expanded the number
of positions of data available in the treatment authorization field on
the bill from 18 to 30. In addition, the National Uniform Billing
Committee has created occurrence code 50 for assessment reference
dates. This new code will allow a separate field for HHAs to report the
M0090 assessment date currently carried in the treatment authorization
field. These two changes provide enough space on the HH PPS bill for
HHAs to encode all the OASIS payment items on the bill, potentially
enabling CMS to compute the HIPPS code during claims processing.
However, a major challenge exists with the feasibility of computing
the HH PPS group during claims processing. A centralized HH PPS grouper
would look to the diagnoses on the HH PPS bill for grouping. The Health
Insurance Portability and Accountability Act (HIPAA) authorized us to
require that all diagnoses on the bill comply with ICD-9-CM coding
guidelines as set out at 45 CFR 162.1002 (65 FR 50370, August 17,
2000). Currently, when certain conditions apply, to prevent the loss of
case mix points, the HH PPS grouper will award case-mix points to some
diagnoses reported as a secondary diagnosis when the assignment is
performed to comply with ICD-9-CM coding requirements. CMS currently
instructs HHAs to report these diagnoses in M1024 (previously M0246) on
the OASIS to prevent loss of case mix points.
We provide detailed guidance on this topic in page 5 of Appendix D
within the OASIS Implementation Manual, which can be accessed at http://www.cms.gov/HomeHealthQualityInits/downloads/HHQIAttachmentD.pdf. This
coding guidance has been provided to prevent the loss of case mix
points when an underlying case mix diagnosis is associated with the
primary V-code diagnosis.
As required by 45 CFR 162.1002, those diagnoses currently encoded
in M1024 (formerly M0246) which should not be reported as primary or
secondary diagnoses cannot be reported on the bill. In an attempt to
solve this challenge, CMS is analyzing options to map diagnoses
currently reported in M1024 (formerly M0246) to diagnoses that are
reportable as primary and secondary diagnoses in the home health
setting, per ICD-9-CM coding guidelines. We have been encouraged with
our ability to map some trauma codes reported in M1024 to after-care
codes which are reportable as primary and secondary diagnoses in the
home health setting. However, additional analysis and mapping are
needed to fully resolve this challenge.
We are soliciting public comment on this potential enhancement,
described above, to assign the HIPPS code to the HH PPS bill during
claim processing. This would require HHAs to report all the OASIS items
necessary to group the episode on the HH PPS bill. As stated above,
doing so would address the costs and burden HHAs currently experience
with regards to frequent updates of a complex HH PPS grouper, address
vulnerabilities that HHAs have associated with the possible submission
of inaccurate HIPPS codes on the claim, while better positioning HHAs
and CMS for the ICD-9 to ICD-10 transition. We are in the early stages
of assessing the feasibility of such changes, and wanted to seize the
opportunity to solicit the public for their comments on this topic.
J. Proposed New Requirements Affecting Hospice Certifications and
Recertifications
In its March 2009 Report to Congress, MedPAC wrote that additional
controls are needed to ensure adequate accountability for the hospice
benefit. MedPAC reported that greater physician engagement is needed in
the process of certifying and recertifying patients' eligibility for
the Medicare hospice benefit. The Commission reported that measures to
ensure accountability would also help ensure that hospice is used to
provide the most appropriate care for eligible patients. They
recommended these measures be directed at hospices that tend to enroll
very long-stay patients. Specifically, MedPAC recommended that a
hospice physician or advanced practice nurse visit the patient to
determine continued eligibility prior to the 180-day recertification
and each subsequent recertification, and attest that such visits took
place. MedPAC, Report to the Congress: Medicare Payment Policy, Chapter
6, March 2009, pp. 365-371.
Section 3132 of The Affordable Care Act requires hospices to adopt
MedPAC's hospice program eligibility recertification recommendations.
Specifically, the bill amends section 1814(a)(7) of the Social Security
Act to require that on and after January 1, 2011, a hospice physician
or nurse practitioner (NP) must have a face-to-face encounter with
every hospice patient to determine the continued eligibility of that
patient prior to the 180-day recertification, and prior to each
subsequent recertification. Furthermore, the bill requires that the
hospice physician or NP attest that such
[[Page 43270]]
a visit took place, in accordance with procedures established by the
Secretary of the Department of Health and Human Services. The
Affordable Care Act provision does not amend the statutory requirement
that a physician must certify and recertify a patient's terminal
illness, and thus NPs continue to not be allowed to certify the
terminal illness. Rather, the provision allows for a NP to furnish a
face-to-face encounter; the NP would then provide the clinical findings
from that encounter to the physician who is considering recertifying
the patient. This new statutory requirement will better enable hospices
to comply with hospice eligibility criteria, and to identify and
discharge patients who do not meet those criteria.
Hospices which admit a patient who received hospice services
previously (from the admitting hospice or from another hospice) must
consider the patient's entire Medicare hospice stay to determine which
benefit period the patient is in, and whether a face-to-face visit will
be required for recertification.
As required by the Affordable Care Act, we are making several
proposals regarding 42 CFR 418.22(a)(3), (a)(4), (b)(3), (b)(4), and
(b)(5) in order to implement this new statutory requirement. Required
visits should be fairly close to the recertification date, so that the
visit allows a current assessment of the patient's continued
eligibility for hospice services. These visits can be scheduled in
advance, particularly for those patients with diagnoses where life
expectancy is harder to predict. At Sec. 418.22(a)(4) we propose that
hospice physicians or NPs make these required visits no more than 15
calendar days prior to the 180-day recertifications and subsequent
recertifications, and that the visit findings be used by the certifying
physician to determine continued eligibility for hospice care. This 15-
day timeframe also aligns the timeframes for recertification visits
with that required for the comprehensive assessment update, as
specified in our Conditions of Participation (CoPs) at Sec. 418.54(d).
This timeframe requirement is also consistent with the timeframe
required for the review of the plan of care, as specified in our CoPs
at Sec. 418.56(d). The 15-day timeframe provides a balance between
flexibility in scheduling the visit, and enabling a relatively current
assessment of continued eligibility while also allowing efficiency in
update and review processes as required by the hospice CoPs.
As noted above, the statute requires that the face-to-face
encounter be used to determine the patient's continued eligibility for
hospice services. We propose that the clinical findings gathered by the
NP or by the physician during the face-to-face encounter with the
patient be used in the physician narrative to justify why the physician
believes that the patient has a life expectancy of 6 months or less. We
propose to add this requirement to 418.22(b)(3) as subparagraph(v).
The statute also requires the hospice physician or NP to attest
that the face-to-face encounter occurred. Again we reiterate that while
NPs can make these visits and attest to them, by statute only a
physician may certify the terminal illness. Therefore, at Sec.
418.22(b)(4) we propose that the face-to-face attestation and signature
be either a separate and distinct area on the recertification form, or
a separate and distinct addendum to the recertification form, that is
easily identifiable and clearly titled. We also propose that the
attestation language be located directly above the physician or NP
signature and date line.
The attestation is a statement from the physician or NP which
attests that he or she had a face-to-face encounter with the patient,
and that the clinical findings of that encounter have been provided to
the certifying physician for use in determining continued eligibility
for hospice care. The attestation should include the name of the
patient visited, the date of the visit, and be signed and dated by the
NP or physician who made the visit. Hospices are free to use other
attestation language, provided that it incorporates these required
elements. These elements would be suitable whether the visit is made by
an NP or a physician. It is possible that the certifying hospice
physician is the same physician who made the visit.
We propose revising our regulations at Sec. 418.22 to incorporate
these requirements. Specifically, we propose adding subsections (a)(4)
and (b)(4) to implement the requirements for a face-to-face encounter
with long-stay hospice patients and the attestation of that face-to-
face encounter.
In proposing a required timeframe in which the face-to-face
encounter must occur, for consistency, we believe it is important to
also propose to clarify required timeframes for all certifications and
recertifications. Long-standing guidance in our Medicare Benefit Policy
Manual's chapter on hospice benefit policy allows the initial
certification to be completed up to 14 days in advance of the election,
but is silent on the timeframe for advance completion of
recertifications (see CMS Pub. No. 100-02, chapter 9, section 20.1). To
clarify our policy in the regulations, and to be consistent with the
proposed timeframe for the newly legislated face-to-face encounter for
recertifications, we propose that both certifications and
recertifications must be completed no more than 15 calendar days prior
to either the effective date of hospice election (for initial
certifications), or the start date of a subsequent benefit period (for
recertifications). This proposal is also in keeping with the CoP
timeframe for updating the comprehensive assessment (418.56(d)), and
with the CoP timeframe for reviewing the plan of care (418.54(d)).
Finally, this proposed 15-day advance certification or recertification
timeframe would also help ensure that the decision to recertify is
based on current clinical findings, enabling greater compliance with
Medicare eligibility criteria. Congress' desire for increased
compliance with Medicare eligibility criteria is one factor which we
believe led to the new statutory requirements. We propose to revise
Sec. 418.22(a)(3) to reflect the above proposals.
Furthermore, longstanding manual guidance stipulates that the
physician(s) must sign and date the certification or recertification.
However, the HHS Office of Inspector General recently found that
certifications for some hospice patients failed to meet Federal
requirements, including those with no signatures [HHS OIG, ``Medicare
Hospice Care for Beneficiaries in Nursing Facilities: Compliance with
Medicare Coverage Requirements, September 2009'']. In keeping with
Congress's desire for increased compliance with Medicare eligibility
criteria, and to achieve consistency with the proposed 180-day
recertification attestation requirements, we propose to add language to
the certification requirements in our regulations to clarify that these
documents must include the signature(s) of the physician(s) and the
date each physician signed.
With the new statutory requirements for a face-to-face encounter
prior to the 180-day recertification, and for every recertification
thereafter, it is important for hospices to easily identify which
benefit periods require a recertification visit. Because hospice
patients are allowed two 90-day benefit periods followed by an
unlimited number of 60-day benefit periods, every 60-day benefit period
is by definition beyond the 180-day recertification. We do not
currently require that certifications or recertifications show the
dates of the benefit period to which they apply, so we propose to add
language to our certification and recertification regulations to make
this a requirement for all hospices. While many hospices already
include this information, there are some that do not. Having the
benefit
[[Page 43271]]
period dates on the certification makes it easier for the hospice to
identify those benefit periods which require a face-to-face encounter
and will ease enforcement of this new statutory requirement.
A valid certification or recertification is a requirement for
Medicare coverage under the Social Security Act at section
1814(a)(7)(A). Additionally, the Act at 1814(a)(7)(D) now also requires
a face-to-face encounter with patients who reach the 180-day
recertification. Changing our regulations to require the physician's
signature(s), date signed, and benefit period dates on the
certification or recertification is necessary to determine if these
documents are valid, and to ease the implementation of the new
statutory requirements. Because we believe these proposed requirements
establish in regulation that which are current practice in the hospice
industry, we do not believe that these proposals will be burdensome to
hospices. As such, we propose adding Sec. 418.22(b)(5) to our
regulations to incorporate these signature and date requirements.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day 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 Therapy Coverage Requirements
As described previously in this proposed rule, we are clarifying
our coverage requirements for skilled services provided by therapists,
which are described in 42 CFR 409.44(c). Our proposed clarifications
include requirements to: document necessity for a course of therapy
(Sec. 409.44(c)(1)); include clinic notes which reflect progress
toward goals, which incorporate the functional assessment and
reassessments, which justify medical necessity, which describe the
content of progress notes, and which include objective evidence of the
expectation that the patient's condition will improve (Sec.
409.44(c)(2)(i)); document any variable factors that influence the
patient's condition or affect the patient's response to treatment, and
include objective measurements of progress toward goals in the clinical
record (409.44(c)(2)(iv)).
These proposed clarifications to our coverage requirements in Sec.
409.44(c) are already part of our current Conditions of Participation
(CoPs) and are approved under OMB 0938-1083. The current CoPs
at Sec. 484.12 already require that the HHA and its staff comply with
accepted professional standards and principles that apply to
professionals furnishing services in an HHA. Those accepted
professional standards include complete and effective documentation,
such as we described in our proposals. Additionally, Sec. 484.32 of
the CoPs already requires in part that the therapist prepare clinical
and progress notes. Section 484.55 of the CoPs already requires that
HHAs provide a comprehensive assessment that ``accurately reflects the
patient's current health status and includes information that may be
used to demonstrate progress toward achievement of desired outcomes''.
Because these proposed clarifications to our coverage requirements in
Sec. 409.44(c) reflect longstanding policy from our CoPs as well as
from accepted standards of clinical practice, we believe that these
proposed requirements will not create any additional burden on HHAs.
Additionally, our coverage regulations at Sec. 409.44(c)(2)(i)
already mandate that for therapy services to be covered in the home
health setting, the services must be considered under accepted practice
to be a specific, safe, and effective treatment for the beneficiary's
condition. We proposed revising Sec. 409.44(c)(2)(i) to require a
functional assessment on the 13th and 19th therapy visit, and at least
every 30 days, to determine continued need for therapy services, and to
ensure material progress toward goals. The functional assessment does
not require a special visit to the patient, but is conducted as part of
a regularly scheduled therapy visit. Functional assessments are
necessary to demonstrate progress (or the lack thereof) toward therapy
goals, and are already part of accepted standards of clinical practice,
which include assessing a patient's function on an ongoing basis as
part of each visit.
Our current CoPs at Sec. 484.55 already require that HHAs
``identify the patient's continuing need for home care * * *''.
Functional assessments of therapy need guide HHAs in determining
whether continued therapy is necessary. Therefore, we believe that the
proposed requirement to perform a functional assessment at the 13th and
19th visits, and at least every 30 days, will also not create any
burden on HHAs. Rather, we have clarified the minimum timeframes for
functional assessments in the coverage regulations. Longstanding CoP
policy at Sec. 484.55 requires HHAs to document progress toward goals;
therefore, we again do not believe that performing or documenting
functional assessments at these 3 time-points would create a new
burden. Both the functional assessment and its accompanying
documentation are already part of existing HHA practices and accepted
standards of clinical practice, and are approved under OMB
0938-1083. Therefore, we do not believe these proposed requirements
place any new documentation requirements on HHAs. We also believe that
a prudent home health agency would self-impose these requirements in
the course of doing business.
We are revising the currently approved PRA package (OMB
0938-1083) to describe these clarifications to the regulatory
text.
B. ICRs Regarding HHA Capitalization
As stated above, we propose to revise Sec. 489.28(a) to clarify
that a newly enrolling HHA must consistently maintain sufficient
capitalization between the time it submits its enrollment application
until three months after its provider agreement becomes effective. This
means the HHA will be required to submit proof of capitalization at
multiple points during this period. For purposes of these collection
requirements only, we estimate that a newly enrolling HHA will be
required to submit such proof 3 times prior to receiving Medicare
billing privileges, and that the burden involved in doing so will be
1.5 hours on each occasion. We further project that 500 newly enrolling
HHAs (of which 200 will ultimately become enrolled) will be asked to
provide this data. The total annual burden will therefore be 2,250
hours (500 HHAs x 3 submissions x 1.5 hours), as reflected in Table 14
below.
[[Page 43272]]
[GRAPHIC] [TIFF OMITTED] TP23JY10.014
C. ICRs Regarding the Home Health Face-To-Face Encounter Requirement
The Affordable Care Act of 2010 amends the requirements for
physician certification of home health services contained in sections
1814(a)(2)(C) and 1835(a)(2)(A) by requiring that prior to certifying a
patient as eligible for home health services, the physician must
document that the physician himself or herself or specified non-
physician practitioner has had a face-to-face encounter (including
through the use of telehealth). The Affordable Care Act provision does
not amend the statutory requirement that a physician must certify a
patient's eligibility for Medicare's home health benefit (see sections
1814(a)(2)(C) and 1835(a)(2)(A) of the Act). In this proposed rule, we
propose that Sec. 424.22(a)(1)(v) require the certifying physician
sign and date the documentation entry into the certification that the
face-to-face patient encounter occurred no more than thirty days prior
to the home health start of care date by himself or herself, or by an
allowed non-physician practitioner for initial certifications. We are
proposing that the certifying physician's documentation of the face-to-
face patient encounter be either a separate and distinct area on the
certification, or a separate and distinct addendum to the
certification, that is easily identifiable and clearly titled, dated,
and signed by the certifying physician, and that it include the
clinical findings of that encounter.
The burden associated with the documentation requirement for the
patient's face-to-face encounter by the physician and certain allowed
non-physician practitioners includes the time for each home health
agency to develop a revised certification form or certification
addendum which the HHA provides to the physician. The revised
certification form or addendum to the certification must allow the
physician to record that a face-to-face patient encounter has occurred.
The revised form or addendum must also include the patient's name, a
designated space for the physician to provide the date of the patient
encounter, a designated space for the physician's documentation of the
face-to-face encounter, and a designated space for the physician to
provide his/her signature and the date signed.
There were 9,432 home health agencies that filed claims in CY 2008.
We estimate it would take each HHA 15 minutes of the home health
administrator's time to develop and review the above described form
language and 15 minutes of clerical time for each HHA to revise their
existing initial certification form or to create an addendum with that
form language. The estimated total one-time burden for developing the
patient encounter form would be 4,716 hours.
The certifying physician's burden for composing the face-to-face
documentation which includes how the clinical findings of the encounter
support eligibility; writing, typing, or dictating the face-to-face
documentation; signing, and dating the patient's face-to-face encounter
is estimated at 5 minutes for each certification. We estimate that
there would be 2,926,420 initial home health episodes in a year based
on our 2008 claims data. As such, the estimated burden for documenting,
signing, and dating the patient's face-to-face encounter would be
243,868 hours for CY 2011.
We reiterate that our longstanding policy has been that physicians
must sign and date the certification statement that the patient is in
need of home health services and meets the eligibility requirements to
receive the benefit. Therefore, our making this requirement explicit in
the regulation poses no additional burden to home health agencies.
Additionally, it has been our longstanding manual policy that
physicians must sign and date the certification and any
recertifications. Our current regulations only address the physician's
signing of the certification and recertification. In this rulemaking,
we are proposing to strengthen our regulations at Sec. 424.22 to
achieve consistency with the proposed timing and documentation of the
face-to-face encounter and to mirror our longstanding manual policy by
revising our regulations to make it a requirement that physicians not
only sign, but also date certifications and recertifications. Because
it has been our longstanding manual policy that physicians sign and
date certifications and recertifications, and we are merely making this
requirement explicit in our regulations, there is no additional burden
to physicians.
Based on the criteria for payment of physician supervision of a
patient receiving Medicare-covered services provided by a participating
home health agency as stipulated in the description of HCPC code G0181,
our making the patient encounter requirement explicit in the regulation
poses no additional burden to physician offices. Table 15a and 16a
below summarizes the burden estimate associated with these
requirements.
[[Page 43273]]
[GRAPHIC] [TIFF OMITTED] TP23JY10.015
Details of our burden estimates are available in the Paperwork
Reduction Act (PRA) package approved under OMB 0938-1083. We
are revising this currently approved package to incorporate these
requirements.
D. ICRs Regarding the Requirements for Hospice Certification Changes
As described previously in this proposed rule, as of January 1,
2011 the Affordable Care Act requires physicians or NPs to attest that
they determined continued hospice eligibility through a face-to-face
encounter with all hospice patients prior to the 180-day
recertification. We proposed that Sec. 418.22(b)(4) require the
physician or NP to sign and date an attestation statement that he or
she had a face-to-face encounter with the patient, and include the date
of that visit. This attestation would be a separate and distinct part
of the physician recertification, or an addendum to the physician
recertification.
The burden associated with this attestation requirement would be
the time for each hospice to develop simple attestation language to
attach as an addendum or include as part of the recertification
document, and the time for the physician or NP to include the patient
name, the date that the patient was visited, the visiting physician or
NP signature, and the date signed. As of February 2010, there were
3,429 hospices with claims filed in FY 2009. We estimate it would take
each hospice 15 minutes of administrative time to develop and review
the attestation language, and 15 minutes of clerical time to revise
their existing recertification form or to create an addendum. The
estimated total one-time burden for developing the attestation form
would be 1,714 hours.
The burden for completing the attestation form is estimated at 30
seconds for each recertification at 180 days or beyond. We used the
distribution of lengths of stay from hospice claims data to estimate
the percentage of patients who required recertification at 180 days,
and at subsequent 60-day benefit periods. We estimated that there would
be 457,382 recertifications at 180 days or beyond, each of which
requires an attestation. We assume that ninety percent of the visits
were performed by physicians and ten percent by nurse practitioners,
based on our analysis of FY 2009 physician and NP hospice billing data,
with 30 seconds time allowed to sign and date the attestation
statement, and to write in the name of the patient and the date of the
visit, resulting in an estimated total burden to complete the
attestation form of 3,811 hours for CY 2011. In the FY 2010 hospice
rule (74 FR 39384) we finalized a requirement that the recertifying
physician include a brief narrative explanation of the clinical
findings which support continued hospice eligibility. Effective January
1, 2011 we propose regulation text changes that this narrative would
describe why the clinical findings of the face-to-face encounter,
occurring at the 180-day recertification and all subsequent
recertifications, continue to support hospice eligibility. However,
these proposed regulation changes are for clarification. The narrative
requirement finalized in FY 2010 requires that the narrative include
why the clinical findings of any physician/NP/patient encounter support
continued hospice eligibility. Therefore, the only documentation burden
associated with this requirement is the signed and dated attestation
that the encounter occurred.
We reiterate that our longstanding policy has been that physicians
must sign and date the certification and any recertifications.
Therefore, our making this requirement explicit in the regulation poses
no additional burden to hospices. We also proposed to clarify the
timeframe which the certifications and recertifications cover by
requiring physicians to include the dates of the benefit period to
which the certification or recertification applies. We believe this is
already standard practice at nearly all hospices, but are addressing it
in regulation. Using the distribution of lengths of stay from 2007 and
2008 claims data, we estimate that there would be 1,733,663 initial
certifications and recertifications during the course of a year. We
estimate that it would take a physician 30 seconds at most to include
the benefit period dates. We estimate that the time to require
physicians to include the benefit period dates on the certification or
recertification would be 30 seconds per certification or
recertification, for a total burden of 14,447 hours for CY 2011. Table
17 below summarizes the burden estimate associated with these
requirements.
[[Page 43274]]
[GRAPHIC] [TIFF OMITTED] TP23JY10.016
Details of our burden estimates are available in the PRA package
approved under OMB 0938-1067. We are revising this currently
approved package to incorporate these requirements.
E. ICRs Regarding the Home Health Care CAHPS Survey (HHCAHPS)
As part of the DHHS Transparency Initiative on Quality Reporting,
CMS is implementing a process to measure and publicly report patients'
experiences with home health care they receive from Medicare-certified
home health agencies with the Home Health Care CAHPS (HHCAHPS) survey.
The HHCAHPS was developed and tested by the Agency for Healthcare
Research and Quality (AHRQ) and is part of the family of CAHPS surveys,
is a standardized survey for home health patients to assess their home
health care providers and the quality of the home health care they
received. Prior to the HHCAHPS, there was no national standard for
collecting data about home health care patients' perspectives of their
home health care.
It is proposed that Section 484.250, Patient Assessment Data, will
require an HHA to submit to CMS HHCAHPS data in order for CMS to
administer the payment rate methodologies described in Sec. Sec.
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 HHCAHPS data, the
patient burden to respond to the survey, and the cost to the HHA to pay
the survey vendor to collect the data on their behalf. This burden is
currently accounted for under OMB 0938-1066.
The HHCAHPS survey received OMB clearance on July 18, 2009, and the
number is 0938-1066. In that PRA package, we did not state the burden
to the HHAs concerning the hours that they would need to secure an
approved HHCAHPS vendor and to pay for that vendor. In this proposed
rule, we have included the burden directly affecting HHAs, which is the
burden to select a survey vendor from http://www.homehealthcahps.org
and to sign a contract with that survey vendor, that will conduct
HHCAHPS on behalf of the HHA. We have determined that this would take
16.0 hours for each HHA. It is noted that 91% of all HHAs (9,890 HHAs
of a total of 10,998 HHAs) would be conducting HHCAHPS, since about 9%
of HHAs will be exempt from conducting HHCAHPS because they have less
than 60 eligible patients in the year. In TABLE 18, we have listed this
burden to the HHAs:
[GRAPHIC] [TIFF OMITTED] TP23JY10.017
OMB Number 0938-1066 will be revised to reflect the update
concerning burden to the HHAs for vendor services for HHCAHPS.
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).
In the Home Health Prospective Payment System Rate Update for
Calendar Year 2010 (August 13, 2009), we proposed to expand the home
health quality measures reporting requirements to include the
CAHPS[supreg] Home Health Care (HHCAHPS) Survey, as initially discussed
in the May 4, 2007, proposed rule (72 FR 25356, 25452) and in the
November 3, 2008, Notice (73 FR 65357, 65358). As part of the DHHS
Transparency Initiative, we proposed to implement a process to measure
and publicly report patient experiences with home health care using a
survey developed by AHRQ in its CAHPS[supreg] program. In the Final
Rule for CY 2010, published on November 10, 2009, we stated our
intention to move forward with the HHCAHPS and link the survey to the
CY 2012 annual payment update under the DRA ``pay-for-reporting''
requirement.
As part of this requirement, each HHA sponsoring a HHCAHPS Survey
must
[[Page 43275]]
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.
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-1510-P];
Fax: (202) 395-6974; or
E-mail: [email protected].
IV. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993), 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 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 major 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
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. CY 2011 Update
The update set forth in this proposed rule applies to Medicare
payments under HH PPS in CY 2011. Accordingly, the following analysis
describes the impact in CY 2011 only. We estimate that the net impact
of the proposals in this rule is approximately $900 million in CY 2011
savings. The $900 million impact to the proposed CY 2011 HH PPS
reflects the distributional effects of an updated wage index ($20
million increase), the 1.4 percent home health market basket update
($270 million increase), the 3.79 percent case-mix adjustment
applicable to the national standardized 60-day episode rates and the
NRS conversion factor ($700 million decrease), as well as the 2.5
percent returned from the outlier provisions of the Affordable Care Act
($490 million decrease). The $900 million in savings is reflected in
the first row of column 3 of Table 15 below as a 4.63 percent decrease
in expenditures when comparing the current CY 2010 HH PPS to the
proposed CY 2011 HH PPS.
The RFA requires agencies to analyze options for regulatory relief
of small businesses, 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 less than $7.0 million to $34.5 million in any 1 year. The
Secretary has determined that this proposed rule would not have a
significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603. 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 HHAs. Therefore,
the Secretary has determined that this proposed rule would not have a
significant economic impact on the operations of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2010, that
threshold is approximately $135 million. 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 $135 million or more.
Executive Order 13132 establishes 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 2010 notice published on November 10, 2009. 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 variable 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 2008. We note that certain events may combine
to limit the scope or accuracy of our impact analysis, because such an
analysis is future-oriented and, thus, susceptible to 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, The Affordable Care Act of 2020, or new statutory provision.
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 15 below represents how HHA revenues are likely to be
affected by the policy changes proposed in this rule. For this
analysis, we used linked home
[[Page 43276]]
health claims and OASIS assessments; the claims represented a 20-
percent sample of 60-day episodes occurring in CY 2008. The first
column of Table 15 classifies HHAs according to a number of
characteristics including provider type, geographic region, and urban
and rural locations. The second column shows the payment effects of the
wage index only. The third column shows the payment effects of all the
proposed policies outlined earlier in this rule. For CY 2011, the
average impact for all HHAs is a .11 percent increase in payments due
to the effects of the wage index. The overall impact, for all HHAs, in
estimated total payments from CY 2010 to CY 2011, is a decrease of
approximately 4.75 percent.
Section 3131(c) of the Affordable Care Act amended section 421(a)
of the MMA of 2003. The amended section 421(a) provides an increase of
3 percent of the payment amount otherwise made for home health services
furnished in a rural area, with respect to episodes and visits ending
on or after April 1, 2010 and before January 1, 2016. Column 3 of Table
19 displays a comparison of estimated payments in CY 2010, including a
3 percent rural add-on for the last three quarters of CY 2010, to
estimated payments in CY 2011, including a 3 percent rural add-on for
all four quarters of CY 2011.
BILLING CODE 4120-01-P
[[Page 43277]]
[GRAPHIC] [TIFF OMITTED] TP23JY10.018
[[Page 43278]]
[GRAPHIC] [TIFF OMITTED] TP23JY10.019
BILLING CODE 4120-01-C
[[Page 43279]]
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 20 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
$930 million.
[GRAPHIC] [TIFF OMITTED] TP23JY10.020
D. Conclusion
In conclusion, we estimate that the net impact of the proposals in
this rule is approximately $900 million in CY 2011 savings. The $900
million impact to the proposed CY 2011 HH PPS reflects the
distributional effects of an updated wage index ($20 million increase),
the 1.4 percent home health market basket update ($270 million
increase), the 3.79 percent case-mix adjustment applicable to the
national standardized 60-day episode rates and the NRS conversion
factor ($700 million decrease), as well as the 2.5 percent returned
from the outlier provisions of The Affordable Care Act ($490 million
decrease). 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 418
Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 424
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: GENERAL PROVISIONS
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. Amend Sec. 409.44 by--
A. Revising paragraph (c)(1).
B. Republishing paragraph (c)(2) introductory text.
C. Revising paragraph (c)(2)(i).
D. Revising paragraph (c)(2)(iii).
E. Revising paragraph (c)(2)(iv).
The revisions read as follows:
Sec. 409.44 Skilled services requirements.
* * * * *
(c) * * *
(1) Speech-language pathology services and physical or occupational
therapy services must relate directly and specifically to a treatment
regimen (established by the physician, after any needed consultation
with the qualified therapist) that is designed to treat the
beneficiary's illness or injury. Services related to activities for the
general physical welfare of beneficiaries (for example, exercises to
promote overall fitness) do not constitute physical therapy,
occupational therapy, or speech-language pathology services for
Medicare purposes. To be covered by Medicare, all of the requirements
apply as follows:
(i) The patient's plan of care must describe a course of therapy
treatment and therapy goals which are consistent with the evaluation of
the patient's function, and both must be included in the clinical
record.
(ii) The patient's clinical record must include documentation
describing how the course of therapy treatment for the patient's
illness or injury is in accordance with accepted standards of clinical
practice.
(iii) Therapy treatment goals described in the plan of care must be
measurable, and must pertain directly to the patient's illness or
injury, and the patient's resultant functional impairments.
(iv) The patient's clinical record must demonstrate that the method
used to assess a patient's function included objective measurements of
function in accordance with accepted standards of clinical practice,
enabling comparison of successive measurements to determine progress.
(2) Physical and occupational therapy and speech-language pathology
services must be reasonable and necessary. To be considered reasonable
and necessary, the following conditions must be met:
(i) The services must be considered under accepted standards of
clinical practice to be a specific, safe, and effective treatment for
the beneficiary's condition. Each of the following requirements must
also be met:
(A) The patient's function must be initially assessed and
periodically reassessed by a qualified therapist, using a method which
would include objective measurement of function and progress as
described in paragraph (c)(1)(iv) of this section. The measurement
results and corresponding progress, or lack of progress, must be
documented in the clinical record.
(B) If a patient requires 13 or 19 therapy visits, at a minimum,
the patient must be functionally reassessed by a qualified therapist on
the 13th and 19th therapy visits and at least every 30 days. Subsequent
therapy visits will not be covered until:
(1) The qualified therapist has completed the reassessment and
[[Page 43280]]
objectively measured progress (or lack of progress), towards therapy
goals.
(2) The qualified therapist has determined if goals have been
achieved or require updating.
(3) The qualified therapist has documented measurement results and
corresponding therapy progress in the clinical record in accordance
with paragraph (c)(2)(i)(D) of this section.
(4) If the objective measurements of the reassessment do not reveal
progress toward goals, the qualified therapist together with the
physician have determined whether the therapy is still effective or
should be discontinued. If therapy is to be continued in accordance
with paragraph (c)(2)(iv)(B)(1) of this section, the clinical record
must document with a clinically supportable statement why there is an
expectation that anticipated improvement is attainable in a reasonable
and generally predictable period of time in accordance with paragraph
(c)(2)(iii)(A) of this section.
(C) Clinical notes written by therapy assistants may supplement the
clinical record, and if included, must include the date written, the
signature and job title of the writer, and objective measurements or
description of changes in status (if any) relative to each goal being
addressed by treatment. Assistants may not make clinical judgments
about why progress was or was not made, but must report the progress
(or lack thereof) objectively.
(D) Progress documentation by a qualified therapist must include:
(1) The therapist's assessment of improvement and extent of
progress (or lack thereof) toward each therapy goal;
(2) Plans for continuing or discontinuing treatment with reference
to evaluation results and or treatment plan revisions;
(3) Changes to therapy goals or an updated plan of care that is
sent to the physician for signature or discharge;
(4) Documentation of objective evidence or a clinically supportable
statement of expectation that the patient's condition has the potential
to improve or is improving in response to therapy or that maximum
improvement is yet to be attained, and there is an expectation that the
anticipated improvement is attainable in a reasonable and generally
predictable period of time.
* * * * *
(iii) For therapy services to be covered in the home health
setting, one of the following three criteria must be met:
(A) There must be an expectation that the beneficiary's condition
will improve materially in a reasonable (and generally predictable)
period of time based on the physician's assessment of the beneficiary's
restoration potential and unique medical condition.
(1) Material improvement requires that the clinical record
demonstrate that the patient is making functional improvements that are
ongoing, as well as of practical value, when measured against his or
her condition at the start of treatment.
(2) Covered therapy services under the home health benefit shall be
rehabilitative therapy service unless they meet the criteria for
maintenance therapy in paragraph (c)(2)(iii)(B) or (c)(2)(iii)(C) of
this section.
(3) Therapy is covered as rehabilitative therapy when the skills of
a therapist are necessary to safely and effectively furnish or
supervise a recognized therapy service whose goal is improvement of an
impairment or functional limitation. Rehabilitative therapy includes
recovery or improvement in function and, when possible, restoration to
a previous level of health and well being.
(4) If an individual's expected rehabilitation potential would be
insignificant in relation to the extent and duration of therapy
services required to achieve such potential, therapy would not be
considered reasonable and necessary, and thus would not be covered as
rehabilitative therapy services.
(5) Where a patient suffers a transient and easily reversible loss
or reduction of function which could reasonably be expected to improve
spontaneously as the patient gradually resumes normal activities,
therapy would not be considered reasonable and necessary and the
services would not be covered.
(B) The specialized skills, knowledge, and judgment of a qualified
therapist may be required to design or establish a safe and effective
maintenance program required in connection with a specific disease,
ensure patient safety, train the patient, family members and/or
unskilled personnel, and make periodic reevaluations of the maintenance
program.
(1) When indicated, the therapist may develop a maintenance program
to maintain functional status or to prevent decline in function, during
the last visit(s) for rehabilitative therapy.
(2) When a patient qualifies for Medicare's home health benefit
based on an intermittent skilled nursing need, a qualified therapist
may develop a maintenance program to maintain functional status or to
prevent decline in function, at any point in the episode.
(3) Where the establishment of a maintenance program is initiated
after the rehabilitative therapy program has been completed,
development of a maintenance program would not be considered reasonable
and necessary for the treatment of the patient's condition.
(4) If the services are for the establishment of a maintenance
program, they must include the design of the program, the instruction
of the beneficiary, family, or home health aides, and the necessary
periodic reevaluations of the beneficiary and the program to the degree
that the specialized knowledge and judgment of a physical therapist,
speech-language pathologist, or occupational therapist is required.
(C) The skills of a therapist must be necessary to perform a safe
and effective maintenance program required in connection with a
specific disease. Where the clinical condition of the patient is such
that the services required to maintain function involve the use of
complex and sophisticated therapy procedures to be delivered by the
therapist himself/herself (and not an assistant) in order to ensure the
patient's safety and to provide both a safe and effective maintenance
program, then those reasonable and necessary services shall be covered.
(iv) The amount, frequency, and duration of the services must be
reasonable and necessary, as determined by a qualified therapist and/or
physician, using accepted standards of clinical practice.
(A) Where factors exist that would influence the amount, frequency
or duration of therapy services, especially factors that influence the
clinical decisions to provide more services than are typical for the
patient's condition, those factors must be included in the plan of care
and/or functional assessment.
(B) Clinical records must include documentation using objective
measures that the patient continues to progress towards goals. If
progress cannot be measured, and continued improvement cannot be
expected, therapy services cease to be covered except when
(1) Therapy progress regresses or plateaus, and the reasons for
lack of progress are documented to include justification that continued
therapy treatment will lead to resumption of progress toward goals; or
(2) Therapy can be considered reasonable and necessary when
maintenance therapy is established or provided, as described in
paragraph (c)(2)(iii)(B) or (C) of this section.
PART 418--HOSPICE CARE
3. The authority citation for part 418 continues to read as
follows:
[[Page 43281]]
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
4. Amend Sec. 418.22 by--
A. Revising paragraph (a)(3).
B. Adding paragraphs (a)(4), (b)(3)(v), (b)(4), and (b)(5).
The revisions and additions read as follows:
Sec. 418.22 Certification of terminal illness.
(a) * * *
(3) Exceptions. (i) If the hospice cannot obtain the written
certification within 2 calendar days, after a period begins, it must
obtain an oral certification within 2 calendar days and the written
certification before it submits a claim for payment.
(ii) Certifications may be completed no more than 15 calendar days
prior to the effective date of election.
(iii) Recertifications may be completed no more than 15 calendar
days prior to the start of the subsequent benefit period.
(4) Face-to-face encounter. As of January 1, 2011, a hospice
physician or hospice nurse practitioner must visit each hospice
patient, whose total stay across all hospices is anticipated to reach
180 days, no more than 15 calendar days prior to the 180-day
recertification, and must continue to visit that patient no more than
15 calendar days prior to every recertification thereafter, to gather
clinical findings to determine continued eligibility for hospice care.
(b) * * *
(3) * * *
(v) The narrative associated with the 180-day recertification and
every subsequent recertification must include an explanation of why the
clinical findings of the face-to-face encounter support a life
expectancy of 6 months or less.
(4) The physician or nurse practitioner who performs the face-to-
face encounter with the patient described in paragraph (a)(4) of this
section, must attest in writing that he or she had a face-to-face
encounter with the patient, including the date of that visit. The
attestation of the nurse practitioner shall state that the clinical
findings of that visit were provided to the certifying physician, for
use in determining whether the patient continues to have a life
expectancy of 6 months or less, should the illness run its normal
course. The attestation, its accompanying signature, and the date
signed, must be a separate and distinct section of, or an addendum to,
the recertification form, and must be clearly titled.
(5) All certifications and recertifications must be signed and
dated by the physician(s), and must include the benefit period dates to
which the certification or recertification applies.
* * * * *
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. Amend Sec. 424.22 by--
A. Adding paragraph (a)(1)(v).
B. Revising paragraph (a)(2).
C. Revising paragraph (b)(1) introductory text.
D. Revising paragraph (d).
The revisions and additions read as follows:
Sec. 424.22 Requirements for home health services.
* * * * *
(a) * * *
(1) * * *
(v) The physician responsible for performing the initial
certification must document that the face-to-face patient encounter,
which is related to the primary reason the patient requires home health
services, has occurred no more than thirty days prior to the home
health start of care date or within two weeks of the start of the home
health care by including the date of the encounter, and including an
explanation of why the clinical findings of such encounter support that
the patient is homebound and in need of either intermittent skilled
nursing services or therapy services as defined in Sec. 409.42(a) and
(c) respectively. The physician's documentation of the face-to-face
encounter in his/her practice's medical recordkeeping for that patient
must be consistent with, and supportive of, the required documentation
of the face-to-face encounter as part of the certification. Pursuant to
sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act, the face-to-face
encounter must be performed by the certifying physician himself or
herself or by a nurse practitioner, a clinical nurse specialist (as
those terms are defined in section 1861(aa)(5) of the Act) who is
working in collaboration with the physician in accordance with State
law, a certified nurse midwife (as defined in section 1861(gg)of the
Act) as authorized by State law, or a physician assistant (as defined
in section 1861(aa)(5) of the Act) under the supervision of the
physician. The documentation of the face-to-face patient encounter must
be a separate and distinct section of, or an addendum to, the
certification, and must be clearly titled, dated and signed by the
certifying physician.
(A) The non-physician practitioner performing the face-to-face
encounter must document the clinical findings of that face-to-face
patient encounter and communicate those findings to the certifying
physician.
(B) If a face-to-face patient encounter occurred within 30 days of
the start of care but is not related to the primary reason the patient
requires home health services, or the patient has not seen the
certifying physician or allowed non-physician practitioner within the
30 days prior to the start of the home health episode, the certifying
physician or non-physician practitioner must have a face to face
encounter with the patient within two weeks of the start of the home
health care.
(C) The face-to-face patient encounter may occur through
telehealth, in compliance with Section 1834(m) of the Act and subject
to the list of payable Medicare telehealth services established by the
applicable physician fee schedule regulation.
(D) To assure clinical correlation between the face-to-face patient
encounter and the associated home health episode of care, the physician
responsible for certifying the patient for home care must document the
face-to-face encounter on the certification itself, or as an addendum
to the certification (as described in paragraph (a)(1)(v) of this
section), that the condition for which the patient was being treated in
the face-to-face patient encounter is related to the primary reason the
patient requires home health services, and why the clinical findings of
such encounter support that the patient is homebound and in need of
either intermittent skilled nursing services or therapy services as
defined in Sec. 409.42(a) and (c) of this chapter respectively. The
documentation must be clearly titled, dated and signed by the
certifying physician.
(2) Timing & signature. The certification of need for home health
services must be obtained at the time the plan of care is established
or as soon thereafter as possible and must be signed and dated by the
physician who establishes the plan.
(b) * * *
(1) Timing and signature of recertification. Recertification is
required at least every 60 days, preferably at the time the plan is
reviewed, and must be signed and dated by the physician who reviews the
plan
[[Page 43282]]
of care. The recertification is required at least every 60 days when
there is a--
* * * * *
(d) Limitation of the performance of physician certification and
plan of care functions. The need for home health services to be
provided by an HHA may not be certified or recertified, and a plan of
care may not be established and reviewed, by any physician who has a
financial relationship as defined in Sec. 411.354 of this chapter,
with that HHA, unless the physician's relationship meets one of the
exceptions in section 1877 of the Act, which sets forth general
exceptions to the referral prohibition related to both ownership/
investment and compensation; exceptions to the referral prohibition
related to ownership or investment interests; and exceptions to the
referral prohibition related to compensation arrangements. Non-
physician practitioners would be precluded from performing a face-to-
face encounter for the purpose of informing the certifying physician,
as described in sections 1814 and 1835 of the Act, if the non-physician
practitioner is an employee of the HHA, as defined by Section 210(j) of
the Act.
7. Amend Sec. 424.502 by adding the definition of ``Change in
majority ownership'' to read as follows:
Sec. 424.502 Definitions.
* * * * *
Change in majority ownership occurs when an individual or
organization acquires more than 50 percent interest in an HHA during
the 36 following the initial enrollment into the Medicare program or a
change of ownership (including asset sale, stock transfer, merger, or
consolidation). This includes an individual or organization that
acquires majority ownership in an HHA through the cumulative effect of
asset sales, stock transfers, consolidations, mergers during a 36 month
period.
* * * * *
8. Section 424.510 is amended by adding paragraph (d)(9) to read as
follows:
Sec. 424.510 Requirements for enrolling in the Medicare program.
* * * * *
(d) * * *
(9) In order to obtain enrollment and to maintain enrollment for
the first three months after Medicare billing privileges are conveyed,
a home health provider must satisfy the home health ``initial reserve
operating funds'' requirement as set forth in Sec. 489.28 of this
chapter.
* * * * *
9. Section 424.530 is amended by adding paragraph (a)(8) to read as
follows:
Sec. 424.530 Denial of enrollment in the Medicare program.
(a) * * *
(8) Initial reserve operating funds. (i) CMS or its designated
Medicare contractor may deny Medicare billing privileges if within 30
days of a CMS or Medicare contractor request, a home health agency
cannot furnish supporting documentation which verifies that the HHA
meets the initial reserve operating funds requirement found in 42 CFR
489.28(a).
(ii) CMS may deny Medicare billing privileges upon an HHA
applicant's failure to satisfy the initial reserve operating funds
requirement found in 42 CFR 489.28(a)
* * * * *
10. Section 424.535 is amended by adding paragraph (a)(11) to read
as follows:
Sec. 424.535 Revocation of enrollment and billing privileges in the
Medicare program.
(a) * * *
(11) Initial reserve operating funds. CMS or its designated
Medicare contractor may revoke the Medicare billing privileges of a
home health agency (HHA) and the corresponding provider agreement if
within 30 days of a CMS or Medicare contractor request, the HHA cannot
furnish supporting documentation verifying that the HHA meets the
initial reserve operating funds requirement found in 42 CFR 489.28(a).
* * * * *
11. Section 424.550 is amended by adding paragraphs (b)(1) and
(b)(2) to read as follows:
Sec. 424.550 Prohibitions on the sale or transfer of billing
privileges.
(b) * * *
(1) Unless an exception in paragraph (b)(2) of this section
applies, if there is a change in majority ownership of a home health
agency by sale (including asset sales, stock transfers, mergers,
consolidations) 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 Sec. 424.510.
(ii) Obtain a State survey or an accreditation from an approved
accreditation organization.
(2)(i) A publicly-traded company is acquiring another HHA and both
entities have submitted cost reports to Medicare for the previous five
(5) years.
(ii) An HHA's parent company is undergoing an internal corporate
restructuring, such as a merger or consolidation, and the HHA has
submitted a cost report to Medicare for the previous five (5) years.
(iii) The owners of an existing HHA decide to change the existing
business structure (for example, partnership to a limited liability
corporation or sole proprietorship to subchapter S corporation), the
individual owners remain the same, and there is no change in majority
ownership.
(iv) The death of an owner who owns 49 percent or less interest in
an HHA (where several individuals and/or organizations are co-owners of
an HHA and one of the owners dies).
* * * * *
PART 484--HOME HEALTH SERVICES
12. 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 E--Prospective Payment System for HHAs
13. Revise Sec. 484.250 to read as follows:
Sec. 484.250 Patient assessment data.
(a) An HHA must submit to CMS the OASIS-C data described at Sec.
484.55 (b)(1) and Home Health Care CAHPS data in order for CMS to
administer the payment rate methodologies described in Sec. Sec.
484.215, 484.230, and 484.235, and meet the quality reporting
requirements of section 1895(b)(3)(B)(v) of the Act.
(b) An HHA that has less than 60 eligible unique HHCAHPS patients
annually must submit to CMS their total HHCAHPS patient count to CMS in
order to be exempt from the HHCAHPS reporting requirements.
(c) An HHA must contract with an approved, independent HHCAHPS
survey vendor to administer the HHCAHPS on its behalf.
(1) CMS approves an HHCAHPS survey vendor if such applicant has
been in business for a minimum of three years and has conducted surveys
of individuals and samples for at least two years. For HHCAHPS, a
``survey of individuals'' is defined as the collection of data from at
least 600 individuals selected by statistical sampling methods and the
data collected are used for statistical purposes. All applicants that
meet these requirements will be approved by CMS.
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(2) No organization, firm, or business that owns, operates, or
provides staffing for a HHA is permitted to administer its own Home
Health Care CAHPS (HHCAHPS) Survey or administer the survey on behalf
of any other HHA in the capacity as an HHCAHPS survey vendor. Such
organizations will not be approved by CMS as HHCAHPS survey vendors.
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
14. The authority citation for part 489 continues 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).
15. Amend Sec. 489.28 by--
A. Revising paragraph (a).
B. Adding paragraph (c)(1).
B. Adding and reserving paragraph (c)(2).
C. Revising paragraph (g).
The addition and revisions read as follows:
Sec. 489.28 Special capitalization requirements for HHAs.
(a) Basic rule. An HHA entering the Medicare program on or after
January 1, 1998, including a new HHA as a result of a change of
ownership, if the change of ownership results in a new provider number
being issued, must have available sufficient funds, which we term
``initial reserve operating funds,'' at the time of application
submission and at all times during the enrollment process to operate
the HHA for the three month period after Medicare billing privileges
are conveyed by the Medicare contractor, exclusive of actual or
projected accounts receivable from Medicare.
* * * * *
(c) * * *
(1) In selecting the comparative HHAs as described in this
paragraph (c), the CMS contractor shall only select HHAs that have
provided cost reports to Medicare.
(2)[Reserved]
* * * * *
(g) Billing privileges. (1) CMS may deny Medicare billing
privileges to an HHA unless the HHA meets the initial reserve operating
funds requirement of this section.
(2) CMS may revoke the Medicare billing privileges of an HHA that
fails to meet the initial reserve operations funds requirements of this
section within three months of receiving its billing privileges.
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--
Hospital Insurance; and Program No. 93.774, Medicare--Supplementary
Medical Insurance Program)
Dated: May 18, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating Officer, Centers for Medicare
& Medicaid Services.
Approved: July 14, 2010.
Kathleen Sebelius,
Secretary.
Note: The following addenda will not be published in the Code of
Federal Regulations.
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[FR Doc. 2010-17753 Filed 7-16-10; 4:15 pm]
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