Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices, 70372-70486 [2010-27778]
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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations
Table of Contents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 409, 418, 424, 484, and
489
[CMS–1510–F]
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
This final rule sets forth an
update to the Home Health Prospective
Payment System (HH PPS) rates,
including: the national standardized 60day episode rates, the national per-visit
rates, the nonroutine 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 updates the wage index used
under the HH PPS and, in accordance
with the Patient Protection and
Affordable Care Act of 2010 (Affordable
Care Act), updates the HH PPS outlier
policy. In addition, this rule revises the
home health agency (HHA)
capitalization requirements. This rule
further adds clarifying language to the
‘‘skilled services’’ section. The rule
finalizes a 3.79 percent reduction to
rates for CY 2011 to account for changes
in case-mix, which are unrelated to real
changes in patient acuity. Finally, this
rule incorporates new legislative
requirements regarding face-to-face
encounters with providers related to
home health and hospice care.
DATES: Effective Date: These regulations
are effective on January 1, 2011.
FOR FURTHER INFORMATION CONTACT:
Frank Whelan, (410) 786–1302, for
information related to payment
safeguards.
Elizabeth Goldstein, (410) 786–6665, for
CAHPS issues.
Mary Pratt, (410) 786–6867, for quality
issues.
Randy Throndset, (410) 786–0131, for
overall HH PPS issues.
Kathleen Walch, (410) 786–7970, for
skilled services requirements and
clinical issues.
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SUMMARY:
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I. Background
A. Statutory Background
B. System for Payment of Home Health
Services
C. Updates to the HH PPS
D. Comments Received
II. Provisions of the Proposed Rule and
Response to Comments
A. Case-Mix Measurement
B. Therapy Clarifications
C. Outlier Policy
1. Background
2. Regulatory Update
3. Statutory Update
4. Outlier Cap
5. Loss Sharing Ratio and Fixed Dollar
Ratio (FDL)
6. Imputed Costs
D. CY 2011 Rate Update
1. Home Health Market Basket Update
2. Home Health Care Quality Improvement
a. OASIS
b. Home Health Care CAHPS Survey
(HHCAHPS)
3. Home Health Wage Index
4. CY 2011 Annual Payment Update
a. National Standardized 60-Day Episode
Rate
b. Updated CY 2011 National Standardized
60-Day Episode Payment Rate
c. National Per-Visit Rates Used to Pay
LUPAs and Compute Imputed Costs
Used in Outlier Calculations
d. LUPA Add-on Payment Amount Update
e. Nonroutine Medical Supply Conversion
Factor Update
5. Rural Add-on
E. Enrollment Provisions for HHAs
1. HHA Capitalization
2. HHA Changes of Ownership
F. Home Health Face-to-Face Encounter
G. Future Plans to Group HH PPS Claims
Centrally During Claims Processing
H. New Requirements Affecting Hospice
Certifications and Recertifications
III. Collection of Information Requirements
IV. Regulatory Impact Analysis
SUPPLEMENTARY INFORMATION:
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 (HH) services. Section 4603
of the BBA mandated the development
of the home health prospective payment
system (HH PPS). Until the
implementation of an 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 an HH PPS for all
Medicare-covered HH 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
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Services’’. Section 1895(b)(1) of the Act
requires the Secretary to establish an
HH PPS for all costs of HH services paid
under Medicare.
Section 1895(b)(3)(A) of the Act
requires the following: (1) The
computation of a standard prospective
payment amount includes all costs for
HH 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 HH 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 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 HH services
furnished in a geographic area
compared to the applicable national
average level. Under section
1895(b)(4)(C) of the Act, the wageadjustment 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 Patient
Protection and Affordable Care Act of
2010 (The Affordable Care Act) (Pub. L.
111–148, enacted on March 23, 2010)
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) of the
Affordable Care Act revised section
1895(b)(5) of the Act so that the
standard payment amount is reduced by
5 percent and the total outlier payments
in a given fiscal year (FY) or year may
not exceed 2.5 percent of total payments
projected or estimated. The provision
also makes permanent a 10 percent
agency level outlier payment cap.
In accordance with the statute, as
amended by the BBA, we published a
final rule in the July 3, 2000 Federal
Register (65 FR 41128) to implement the
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1997 HH PPS legislation. The July 2000
final rule established requirements for
the new HH PPS for HH 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 an HH PPS for HH
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 HH
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).
Section 5201(c) of the Deficit
Reduction Act of 2005 (DRA) (Pub. L.
109–171, enacted February 8, 2006)
added new section 1895(b)(3)(B)(v) to
the Act, requiring HHAs to submit data
for purposes of measuring health care
quality, and links the quality data
submission to the annual applicable
percentage increase. This data
submission requirement is applicable
for CY 2007 and each subsequent year.
If an HHA does not submit quality data,
the HH market basket percentage
increase is reduced 2 percentage points.
In the November 9, 2006 Federal
Register (71 FR 65884, 65935), we
published a final rule to implement the
pay-for-reporting requirement of the
DRA, which was codified at
§ 484.225(h) and (i) in accordance with
the statute.
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 of 2003 (MMA) (Pub.
L. 108–173, enacted on December 8,
2003) as amended by section 5201(b) of
the DRA. The amended section 421(a) of
the MMA now requires, for HH 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.
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B. System for Payment of Home Health
Services
Generally, Medicare makes payment
under the HH PPS based on 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 HH disciplines (skilled
nursing, HH aide, physical therapy,
speech-language pathology,
occupational therapy, and medical
social services). Payment for nonroutine
medical supplies (NRS) is no longer part
of the national standardized 60-day
episode rate and is computed by
multiplying the relative weight for a
particular NRS severity level by the NRS
conversion factor (See section III.C.4.e.
of this final rule). Payment for durable
medical equipment covered under the
HH 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 based on a national pervisit 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. The 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.
That rule included an analysis
performed on CY 2005 HH claims data,
which 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.
Subsequently, a more detailed analysis
was performed on the 12.78 percent
increase in case-mix to evaluate if any
portion of the increase was associated
with a change in the actual clinical
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condition of HH patients. We examined
data on demographics, family severity,
and non-HH Part A Medicare
expenditure data to predict the average
case-mix weight for 2005. As a result of
the subsequent detailed analysis, we
recognized that an 11.75 percent
increase in case-mix was due to changes
in coding practices and documentation,
and not to treatment of more resourceintensive patients.
To account for the changes in casemix that were not related to an
underlying change in patient health
status, CMS implemented a reduction
over 4 years in the national
standardized 60-day episode payment
rates and the NRS conversion factor.
That reduction was to be 2.75 percent
per year for 3 years beginning in CY
2008 and 2.71 percent for the fourth
year in CY 2011. We indicated that we
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.
For CY 2010, we published a final
rule in the November 10, 2009 Federal
Register (74 FR 58077) (hereinafter
referred to as the CY 2010 HH PPS final
rule) that sets forth the update to the 60day national episode rates and the
national per-visit rates under the
Medicare prospective payment system
for HH services.
D. Comments Received
In response to the publication of the
CY 2011 HH PPS proposed rule, we
received approximately 500 items of
correspondence from the public. We
received numerous comments from
various trade associations and major
health-related organizations. Comments
also originated from HHAs, hospitals,
other providers, suppliers, practitioners,
advocacy groups, consulting firms, and
private citizens. The following
discussion, arranged by subject area,
includes our responses to the
comments, and where appropriate, a
brief summary as to whether or not we
are implementing the proposed
provision or some variation thereof.
General (Miscellaneous)
Comment: A commenter stated that
multiple policy changes and payment
reductions have led to the industry’s
inability to apply ‘‘cause-and-effect’’
analysis when HH care access becomes
critical. The commenter recommends
applying changes one at a time and
phasing them in to allow time to
determine the impact of those
individual changes. Another commenter
stated that as an HHA owner, she is
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willing to accept cuts to the Medicare
HH benefit but that the cuts need to be
incremental so agencies have the time
and the resources to implement
adjustments in response to payment
changes. In addition, there is the
growing concern of the ‘‘unknown’’ costs
associated with implementation of the
Affordable Care Act. Another
commenter stated that the health
insurance costs for their employees have
skyrocketed over the past 3 years, and
that in conjunction with these cuts, it
hinders their ability to hire staff.
Response: We have, in fact, been
phasing in the reductions to the HH PPS
rates for the increase in nominal casemix. As a result of the CY 2008 final
rule, we have reduced HH PPS rates by
2.75 percent for 2008, 2009, and 2010 to
account for the increase in nominal
case-mix, that is an increase in case-mix
not due to actual changes in patient
characteristics. However, there still
exists significant nominal case-mix
increase in the payment system that has
not yet been addressed. Consequently,
we believe that the case-mix
adjustments continue to be necessary in
order to address the residual increase in
the nominal change in case-mix that has
not yet been accounted for in the
payment system. As such, we are
moving forward with phasing in our
case-mix reductions and will be
applying a 3.79 percent reduction to the
HH PPS rates in CY 2011 (as discussed
in the July 23, 2010 proposed rule). In
response to comments that we received
on our case-mix model and its
measurement of real case-mix, we will
further study the concerns raised and
are not finalizing the proposed 3.79
percent reduction to the HH PPS rates
for CY 2012 at this time. Therefore, in
addition to our continuous monitoring
of nominal case-mix increase, we plan
to perform a review of our case-mix and
NRS models, and address any
reductions to the CY 2012 HH PPS
payments in next year’s rulemaking.
The other policy changes and
reductions addressed in this rule (that
is, outlier provisions and reductions to
the market basket update) were
mandated by the Affordable Care Act.
We are uncertain of the meaning of
‘‘unknown’’ costs as referenced by the
commenter and therefore are unable to
address the particular concern.
Comment: A commenter stated that he
receives calls from providers who are
confused with the language that is used
by CMS in determining billing
requirements. He believes the proposed
changes are a step in the right direction.
Response: We appreciate the
comment and will continue to work
towards providing the industry/public
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with clear policies, instructions, and
guidance as they relate to our payment
policies.
Comment: With the increased use of
technology and telehealth, funds should
be made available to HHAs to include
such monitoring to allow patients and
their families to be more proactive in
the management of their illnesses and to
reduce ER visits, primary care physician
appointments and hospital stays. Home
Health is the area to fund, not to cut,
and that medical spending in other
areas should be reduced.
Response: We are not opposed to
improvements in technology, or the use
of telehealth in the HH setting and
certainly do not discourage the use of
these advances in medicine. However,
under section 1895(e) of the Act,
telehealth services cannot substitute for
in-person HH services ordered as part of
a plan of care. However, telehealth can
be used to supplement traditional HH
services.
Section 1895(b)(3)(B) of the Act
dictates how HH PPS rates are to be
updated annually, and section 3131(a)
of the Affordable Care Act, amending
this provision, requires the Secretary to
rebase HH payments beginning in 2014.
At that time, more up-to-date costs will
be used to rebase payments to HHAs.
Comment: A commenter stated that
the impact analysis in the proposed rule
is useless in that the analysis simply
quantifies the percentage cut in rates on
a geographic basis. Further, the impact
analysis offers little substantive
understanding of the individual cost
impact of such proposed provisions as
the physician face-to-face encounter
requirement, the revisions to therapy
assessment, coverage and
documentation standards, coding
change proposals, and CAHPS
compliance. The estimated costs are
vastly understated because they do not
include the sizeable administrative
expenses that HHAs will incur to
implement any of the changes beyond
the cost of some of the form revisions.
A valid and useful impact analysis
starts with an understanding of the
results of the combination of rate cuts
and cost increases that the proposed
policies will bring to HHAs. The
commenter further asserts that once
these results are fairly and accurately
determined, the impact analysis must
begin with the highest of priority
concerns—impact on access to care—as
that is the central purpose of Medicare.
Second, the commenter believes that the
impact analysis should continue with
an evaluation of the effect of the
proposed policies on total spending for
the Medicare program, not just the effect
on HH services spending.
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The commenter provided the example
that if the analysis of the proposed
policies’ impact on access to care shows
that thousands of Medicare beneficiaries
would no longer have HH care available
or that provision of HH services would
be significantly delayed, Medicare
spending would rise as a result of a shift
to higher cost care such as skilled
nursing facility services or extended
inpatient stays.
The commenter also proposed that the
impact analysis should evaluate the
impact of the proposed policies on
another stakeholder—HHAs as
businesses. Such evaluation should start
with the ongoing viability of the
individual businesses and the industry
as a whole. Among the many elements
that should be reviewed is whether the
business will be paid less than the cost
of the delivery of care. Another element
is the workforce impact—will health
care workers take their talents to other
care sectors because of reductions in
compensation and benefits. Access to
capital is also an important factor to
evaluate. If the proposed rule changes
restrict access to capital, there may be
reduced use of efficiency-related
technologies or business expansions to
achieve economies of scale. Lack of
access to capital could also mean an
inability to meet ongoing payroll
obligations because of cash flow
problems.
The commenter also claimed there is
another flaw in the CMS impact
analysis, which is its limited review to
a single year. This is particularly
concerning to the commenter because
the proposed rule extends rate cuts into
a second year. An impact analysis that
does not evaluate the impact of cuts in
payment rates for both of the years as
proposed is invalid and in violation of
CMS obligations under the Regulatory
Flexibility Act.
The commenter strongly recommends
that CMS conduct a thorough and valid
impact analysis, consistent with the
concerns referenced above. Another
commenter states that in the proposed
rule CMS concluded that the proposed
rule would not have a significant impact
on a substantial number of small
entities. Section 605 of the Regulatory
Flexibility Act (RFA) requires that if the
regulatory agency certifies that the rule
will not have a significant impact on a
substantial number of small businesses,
it must include a statement providing
the factual basis supporting the
certification. The commenter suggests
that CMS failed to provide an adequate
factual basis for its certification that
there would be no significant impact. In
fact, there is no language in the RFA
section of the proposed rule that
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discloses the reasons why CMS
concluded that there would be no
substantial impact on small HHAs. CMS
should at a minimum have provided the
public with information on the number
of HHAs and other health care entities
likely to be affected by the rule. Further,
CMS has guidelines (usually based on
small business revenues) in place that
the agency uses to determine whether a
rule will have a significant impact on a
substantial number of small entities.
CMS failed to discuss how the impacts
of this rule fall within those guidelines.
Such a discussion is vital for the
purposes of transparency, as affected
small entities can use this information
to provide CMS with economic impact
information on the rule’s projected
impact on their business. Based on the
public input, the commenter asserts that
CMS could determine the validity of
their decision to certify the rule in the
publication of the final regulation.
The commenter is concerned that
while CMS has certified that the rule
will not have a significant impact, the
affected HHAs still believe that the
regulation will result in a significant
burden on their businesses. The
commenter believes that there is merit
in bringing these small business
concerns to the attention of CMS in the
hope that they will add to the
transparency of the RFA contained in
the final rule.
Response: The RFA requires agencies
to analyze options for regulatory relief
of small entities, if a rule has a
significant impact on a substantial
number of small entities for that year.
As such, there is no requirement under
the RFA to provide impacts for any
year(s) beyond that which the rule is
updating the rates. For purposes of the
RFA, small entities include small
businesses, nonprofit organizations, and
small governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $7 million to $34.5 million in any 1
year. For purposes of the RFA,
approximately 95 percent of HHAs are
considered small businesses according
to the Small Business Administration’s
size standards, with total revenues of
$13.5 million or less in any one year.
Individuals and States are not included
in the definition of a small entity. As
such, this rule is estimated to have an
overall negative effect upon small
entities (see section IV.B. of this final
rule, ‘‘Anticipated Effects’’, for
supporting analysis).
The last section of Table 19 shows the
percentage change in payments by
agency size, as determined by the
number of first episodes. The agency
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size categories, for this rule, are based
on the number of first episodes in a
random 20 percent beneficiary sample
of CY 2008 claims data. Initial episodes,
under the HH PPS, are defined as the
first episode in a series of adjacent
episodes (contiguous episodes that are
separated by no more than a 60-day
period between episodes) for a given
beneficiary. Initial, or first, episodes are
a good estimate of agency size, because
this method approximates the number
of admissions experienced by the
agency based on approximately one-fifth
of the total annual data. The size
categories were set to have roughly
equal numbers of agencies, except that
the highest category has somewhat more
agencies because added detail amongst
the large size category was not needed.
Because our model does not have the
data to account for the ‘‘total’’ revenue of
an HHA, in the proposed rule, and again
in this final rule, we have used the
number of first episodes as a proxy for
agency size. As such, using the facility
size categories (based on the number of
first episodes), the impact table shows
that the difference in impact between
smaller and larger HHAs is small and
within a 0.05 percentage point range. In
fact, smaller agencies have a smaller
reduction and fare slightly better than
larger agencies represented by the ‘‘200
or more first episodes’’ category.
In an effort to better demonstrate the
impact on small HHAs, as it relates to
total revenue, we supplemented our
impact analysis by linking to Medicare
cost report data, which has total
revenues for HHAs. Using total revenues
and the $13.5 million threshold of the
RFA, we categorized an HHA as being
either small or large. To perform this
analysis, we were able to match
approximately 72 percent of the cost
report data to our model. For the
remainder of the agencies in the model,
we proxy for large agencies as those
agencies with at least 750 first episodes.
This results in approximately 95 percent
of agencies being classified as small and
5 percent of agencies being large, which
is reflective of what our cost report files
show us. This analysis provides similar
results to the one using first episodes as
a measure of an agency’s size in that
small HHAs fare slightly better, ¥4.84
percent impact, than do large HHAs,
which are estimated to experience a
¥5.01 percent (see section IV.B. of this
final rule, ‘‘Anticipated Effects’’, for
supporting analysis).
In a separate, supplemental analysis,
as merely an indicator of possible access
to care issues, we looked at estimated
margins of HHAs, by county, and the
estimated effect that the provisions of
this rule might have on HHAs. In
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particular, we look to identify counties
that might not be served by at least one
HHA with a positive margin as a result
of the finalized policies of this rule. The
analysis demonstrate that occurrence of
such counties is very infrequent; thus,
we do not believe that access to care is
an issue (see section IV.B. of this final
rule, ‘‘Anticipated Effects’’, for
supporting analysis). Given the profit
margins of HHAs that we and MedPAC
are seeing in our analyses, we believe
that the reductions of this final rule can
be absorbed by the majority of HHAs,
and that access to care will not be
compromised. However, we will
continue to monitor the situation to
identify any unintended consequences
of our policies in this final rule.
Comments Regarding Access to Care
Comment: A commenter stated that
additional regulatory responsibilities of
oversight, documentation, education,
choosing survey vendors, etc., would
result in increased costs to HHAs. There
is an inherent risk for decreased quality
of care and volume of services provided
by HHAs. It is possible that HHAs may
become more selective in their
acceptance of medically difficult
patients who are likely to utilize more
services.
Response: We assume that the
commenter is referring to the therapy
provisions of this rule. We believe that
our clarifications to our therapy
coverage requirements do not constitute
additional responsibilities, but rather
clarify the existing responsibilities of
the qualified therapist and the HHA.
Similarly, we are clarifying the existing
supervision/oversight requirements of
qualified therapists in the HH setting.
We are also clarifying our coverage
requirements for education of the
patient and/or family members, and our
documentation requirements. We do not
consider any of these clarifications to be
beyond the current responsibilities of an
HHA.
We are, as part of this final rule,
requiring qualified therapists to perform
the needed therapy service, assess
patients and measure and document
therapy effectiveness at what we
consider key points of the episode. We
believe that all HH patients who need
therapy services would benefit from
those services being delivered by a
qualified therapist, instead of an
assistant, at key points in the course of
treatment. We will continue to monitor
for unintended consequences of the
provisions of this final rule.
Comment: Several commenters stated
that the payment reductions would
result in decreased access to care and
force HHAs out of business. The
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commenters assert that patients who are
moved from acute care facilities to their
homes and have major medical
problems would not be able to get HH
services for their illnesses. These
proposed changes would not only
endanger access to care but also impede
efforts to transition patients to the home
and cripple essential community HHAs.
Several commenters stated that HH
patients would be forced into costly
institutional care and increase Medicare
spending. Another commenter stated
that if these proposed cuts were
implemented, many senior citizens who
have paid taxes in to the Medicare
system for years would be forced to go
into assisted living facilities and nursing
homes or simply not receive the
healthcare they deserve. In addition,
their quality of life would be
compromised.
Response: As discussed in a previous
response to a comment, in a separate
analysis in the regulatory impact section
of this rule, we looked at margins of
HHAs, by county, and the estimated
effect that the provisions of this rule
would have on HHAs. In particular, we
studied the number of counties that
would not be served by at least one
HHA with a positive margin. Our
analysis concluded that there were few
counties in which no HHAs had
positive margins; therefore, we do not
believe that access to care will be
adversely affected by these case-mix
adjustments. Given the data on profit
margins that we and MedPAC saw in
our analyses, we believe that the
reimbursement rate reductions set forth
in this final rule can be absorbed by the
majority of HHAs, and that access to
care will not be compromised.
emcdonald on DSK2BSOYB1PROD with RULES2
II. Provisions of the Proposed Rule and
Response to Comments
A. Case-Mix Measurement
As stated in the proposed rule
published on July 23, 2010, analysis of
HH PPS claims shows total average
case-mix grew at a rate of about 1
percent each year from 2000 to 2007,
with 4 percent growth in 2008. Based on
our analysis of the proportion of total
case-mix change due to changes in real
case-mix severity of the HH user
population, the total amount of case-mix
growth unrelated to real changes in
patient severity (nominal case-mix) is
17.45 percent between 2000 and 2008.
In each of the years 2008, 2009, and
2010, we reduced payment rates by 2.75
percent as recoupment for nominal casemix change. A payment-rate reduction
of 7.43 percent would be needed to
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account for the outstanding amount of
nominal case-mix change we intend to
recoup based on the real case-mix
change analysis updated through 2008.
In the proposed rule, we proposed to
increase the planned 2.71 percent
reduction in CY 2011 to 3.79 percent,
and to make another 3.79 percent
reduction in CY 2012. Doing so would
enable us to account for the 7.43 percent
nominal case-mix residual, while
minimizing access to care risks.
Iteratively implementing the case-mix
reduction over two years gives HH
providers more time to adjust to the
intended reduction of 7.43 percent than
would be the case were we to account
for the residual in a single year.
For a complete description of the
proposed case-mix refinements model
and the underlying research, we refer
readers to the CY 2011 HH PPS
proposed rule (75 FR 43238 through
43244) published in the July 23, 2010,
Federal Register.
Comment: Commenters stated that we
should suspend or drop case-mix
reductions because the proposal is
based on the assumption that agencies
intentionally gamed the system.
Response: As we have stated in
previous regulations, changes and
improvements in coding are important
in bringing about nominal coding
change. We believe nominal coding
change results mostly from changed
coding practices, including improved
understanding of the ICD–9 coding
system, more comprehensive coding,
changes in the interpretation of various
items on the OASIS and in formal
OASIS definitions, and other evolving
measurement issues. Our view of the
causes of nominal coding change does
not emphasize the idea that HHAs in
general gamed the system. However,
since our goal is to pay increased costs
associated with changes in patient
severity, and nominal coding change
does not necessarily demonstrate that
underlying changes in patient severity
occurred, we believe it is necessary to
recoup overpayments due to nominal
coding change.
Comment: Commenters stated that all
of the HHAs are being penalized for the
corrupt actions of a few HHAs. Many
commenters indicated that their agency
had case-mix weights below the
national average. Commenters stated
that nominal case-mix change
reductions should be limited to certain
types of agencies (for example, those
with high average case-mix index (CMI)
or large weight increases or for-profit
providers) or that CMS should
implement different payment reductions
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by state or by geographical region,
suggesting that their region has a lower
nominal case-mix change than the
national average. Other commenters
recommended that reductions be
proportional to an individual agency’s
CMI. For example, some commenters
suggested that payment reductions be
applied to those HHAs with an average
case-mix above 1.20. Commenters stated
that we should not implement payment
reductions to all HHAs merely because
that policy is easier to implement.
Response: For a variety of reasons, as
we have noted in previous regulations,
we have not proposed targeted
reductions for nominal case-mix change.
We have not conducted analysis of how
and whether individual agencies’
coding practices have changed over time
because this is not feasible. One reason
is that many agencies have small patient
populations, which would make it
practically impossible to measure
nominal case-mix change reliably.
Another reason is that we believe
changes and improvements in coding
have been widespread, so that such
targeting would likely not separate
agencies clearly into high and low
coding-change groups.
Table 1A shows average case-mix by
type of agency in 2000 and 2008. All
types of agencies, regardless of region or
profit status or size or affiliation, have
substantial increases in their average
case-mix. While for-profit agencies’
case-mix grew approximately 19
percent, the case-mix average for nonprofit agencies also grew considerably
(16.6 percent). Case-mix grew just over
19.5 percent for freestanding agencies
while case-mix for facility-based
agencies grew just short of 15 percent.
For rural agencies, case-mix grew almost
16 percent, while case-mix for urban
agencies grew just under 19 percent.
Rural agencies will receive an
additional 3 percent rural add-on to
their payments, which will help offset
the case-mix reductions. It should be
noted that the agency groups start from
different base year values, but in general
the percentage change in case-mix is
roughly similar across these groups,
with the possible exception of the
Midwest, for which the percentage
change is somewhat higher than the
other changes—about 23 percent. No
group could be said to have trivial casemix change. Therefore, we believe our
proposal to make across the board
payment reductions is consistent with
the data, and making distinctions by
type of agency would be inappropriate.
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TABLE 1A—ESTIMATES OF CASE-MIX CHANGE BY PROVIDER TYPE
[2000–2008]
Actual case-mix
2000
(IPS period)
Case-mix change
2008
Total
Percentage
Overall
All Agencies .....................................................................................................
1.0959
1.3085
0.2126
19.4
1.0840
1.0672
1.1202
1.2641
1.2291
1.3332
0.1801
0.1619
0.2130
16.6
15.2
19.0
1.0834
1.1035
1.2433
1.3200
0.1599
0.2165
14.8
19.6
1.0422
1.1251
1.0865
1.0956
1.2459
1.337
1.3431
1.2648
0.2037
0.2118
0.2566
0.1692
19.6
18.8
23.6
15.5
1.0898
1.1057
1.2499
1.3266
0.1602
0.2209
14.7
20.0
1.1097
1.0478
1.3184
1.2136
0.2087
0.1657
18.8
15.8
Ownership Type
Non-profit .........................................................................................................
Government .....................................................................................................
For-profit ..........................................................................................................
Agency Type
Facility-based ...................................................................................................
Freestanding ....................................................................................................
Region
North ................................................................................................................
South ................................................................................................................
Midwest ............................................................................................................
West .................................................................................................................
Facility Size (Number of 1st Episodes)
< 99 episodes ...................................................................................................
100 or more .....................................................................................................
Urban/Rural
emcdonald on DSK2BSOYB1PROD with RULES2
Urban ...............................................................................................................
Rural ................................................................................................................
Although we have stated in past
regulations that a targeted system would
be administratively burdensome, the
reasons we have just presented go
beyond administrative complexity.
Certain comments seem to assume that
the level of case-mix can precisely
identify those agencies practicing
abusive coding. We do not agree with
the comments, which seem to assume
that agency-specific case-mix levels can
precisely differentiate agencies
practicing abusive coding from others.
System wide, case-mix levels have risen
over time while patient characteristics
data indicate little change in patient
severity over time. That is, the main
problem is the amount of change in the
billed case-mix weights not attributable
to underlying changes in actual patient
severity. Moreover, we believe that a
policy of varying payment levels
according to regional differences in
nominal case-mix change would be
perceived as inequitable by
beneficiaries. That is, beneficiaries who
might have access only to agencies
subject to larger payment reductions
might believe Medicare’s policies
disadvantage them unfairly.
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Comment: Commenters stated that we
should suspend or drop case-mix
adjustments because they will cause
financial distress/bankruptcy among
agencies, particularly ‘‘safety-net’’
agencies that take patients other
agencies reject. Commenters further
stated that the proposed payment
reductions will cause ‘‘safety net’’
providers to have a ‘‘negative operating
margin’’ and/or cause not-for-profit
agencies to go out of business.
Response: Our analysis of the
potential effect of the 2011 payment rate
reductions suggests that while negativemargin agencies may increase in
number, almost all such agencies are
located in counties with other agencies
predicted to have positive margins. We
also note that predicting the size of the
increase in negative-margin agencies is
difficult to do because many agencies
may find ways to cut costs or increase
revenues so that margins do not
deteriorate. Identifying the agencies that
commenters call ‘‘safety-net’’ agencies is
not feasible with our administrative
data, so we cannot provide any evidence
either to support or refute assertions
that safety-net agencies are at greatest
risk. Our analysis of margins of not-for-
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profit agencies shows that they tend to
have lower margins than for-profit
agencies. However, we do not agree that
not-for-profit agencies will necessarily
be more likely to exit the HH business
than a for-profit agency. We believe the
business decision is a complex one with
many considerations, such as the
organization’s mission, the availability
of alternate sources of funding, and
whether or not the organization is
embedded in a larger one. These
influential factors are not necessarily
associated with the non-profit or forprofit status of an agency, and therefore,
we cannot accurately predict the
business decision of an agency based
solely on their status.
Comment: Commenters stated that we
should suspend or drop case-mix
adjustments because access would be
reduced, particularly among hard-toplace patients. Commenters predicted
that the payment reductions would have
a ‘‘destabilizing effect’’ on HHAs and
negatively impact patient access to HH
care.
Response: MedPac has previously
recommended to the Congress that HH
rates be reduced by 5 percent. (MedPac,
Report to Congress: Medicare Payment
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Policy, March 2009). We believe HH
industry margins are sufficient to
support a rate reduction of that size. For
example, MedPac projected 2011
margins would remain high, at 13.7
percent (assuming the previously
planned rate reduction of ¥2.71 percent
in 2011). MedPac also reported that the
number of agencies continues to grow,
reaching in excess of 10,400 in 2009.
This is a 50 percent increase since 2002,
although growth in new agencies has
been highly uneven geographically.
Notably, access to care was sufficient in
2001, when the number of agencies
nationally was much lower than it is
today (Office of the Inspector General,
Access to Home Health Care after
Hospital Discharge, July 2001, and
Office of the Inspector General,
Medicare Home Health Care Community
Beneficiaries, October 2001). Our
analysis of cost reports submitted by the
end of 2008 indicates that 99 percent of
beneficiaries are in counties served by at
least two agencies, with more than half
of beneficiaries in counties served by at
least 11 agencies. Predictions about the
number of bankruptcies and effects on
access are highly uncertain.
Furthermore, we have no indications
that payment reductions implemented
since 2008 have led to access problems
among beneficiaries. During the
succeeding period, the total number of
agencies has continued to grow, which
is indirect evidence that access levels
have not deteriorated. We intend to
request that the Office of the Inspector
General resume investigations of the
access impacts of payment reductions.
We will continue to monitor access to
care in order to identify any unintended
consequences of our policies in this
final rule. We emphasize that the
justification for the nominal case-mix
payment reductions is not HHA margins
but rather is the increase in billed casemix weights, which our analysis
indicates, is unrelated to changes in
underlying patient health
characteristics.
Comment: Commenters suggested that
we provide funding to HHAs that admit
patients that other agencies avoid.
Response: We have received
comments of this nature over the years.
We are unable to definitively
characterize such a categorization of
HHAs using administrative data. While
we welcome information as to the
characteristics and identity of such
agencies, so that we can study their
performance, we would also need to
study carefully the implications of
making such distinctions on a
permanent basis in our payment system.
We expect many issues would arise. In
future rulemaking we will solicit
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comment on the various challenges that
might arise in administering payments
differently to what some commenters
called ‘‘full access organizations’’ and
potentially other categories of agencies
that might be capable of mitigating
access problems, should they arise.
Comment: Some commenters
suggested that CMS focus its efforts on
the study, which will assess possible
changes to the HH PPS in order to
ensure access to care.
Response: Section 3131(d) of the
Affordable Care Act mandates that the
Secretary conduct a study to evaluate
costs related to providing care to lowincome beneficiaries, beneficiaries in
medically underserved areas, and
beneficiaries with varying levels of
severity of illness. The section directs
the study to be focused on ensuring
access to care for patients with
characteristics associated with
especially high costs. We are preparing
to launch the mandated study in FY
2011.
Comment: Commenters stated that
CMS should suspend or drop nominal
case-mix change reductions because
those payment reductions are contrary
to congressional intent in the Affordable
Care Act, which implemented payment
reductions on a separate basis.
Furthermore, commenters stated that
the 3.79 percent case-mix payment
reduction should count as the ‘‘5 percent
cut mandated by the [Affordable Care
Act]’’ and the proposed payment
decreases should not be implemented in
addition to the Affordable Care Actmandated payment reductions.
Response: Section 3401(e) of the
Affordable Care Act mandated a market
basket reduction and future productivity
adjustments. In the Affordable Care Act,
Congress did not make any changes to
the pre-existing provision authorizing
CMS to reduce payment rates in
response to nominal case-mix change.
Nor did the Congress authorize a
substitution of the case-mix payment
reduction for the Affordable Care Act’s
five percent payment reduction related
to outlier payments (Section 3131(b) of
the Affordable Care Act). Therefore, the
reductions for nominal case-mix
changes comply with current law.
Comment: Commenters stated that
CMS should suspend or drop case-mix
reductions because CMS should give
specific proposals such as therapy
documentation and comorbidity casemix weight changes time to work.
Response: Our proposals are intended
to recoup excess outlays that have
already been made through 2008,
outlays that were not justified by
changes in patient severity. Going
forward, beginning with 2011, we
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would expect to see a moderation of
nominal case-mix growth because of the
proposals mentioned by the
commenters. Such moderation would
decrease recoupment, if any, proposed
in the future.
Comment: A commenter stated that
the need for payment reductions in HH
care is ‘‘consistent with the experience
of coding changes in other payment
systems.’’ However, the methodology
‘‘used to establish the reduction
percentage’’ in the inpatient system was
flawed and, therefore, the methodology
used to establish the payment reduction
for HH is probably flawed as well.
Response: The payment systems,
institutional conditions, data resources,
case-mix assignment procedures, and
many other aspects differ across care
settings. Therefore, methodologies must
each be judged on their own individual
merits. We have explained and justified
the methodology in this and in previous
regulations cited elsewhere in this
preamble.
Comment: We received a comment
recommending that we focus the
application of the case-mix change
adjustment only to visits beyond the
13th day by changing the OASIS scoring
and rate calculation for the extended
cases rather than reducing the base rate
and affecting all visits as a result.
Response: We are unsure of the
specific change recommended in this
comment, but we would be concerned
that any approach to rate reduction
based on the length of time in treatment
within the 60-day episode would affect
fundamental assumptions of the HH
PPS system. Most notably, the system
assumes that the amount of resources
within the 60-day period, rather than
the timing of their expenditure within
that period, is the appropriate variable
use to determine payments in the casemix-adjusted payment system.
Comment: One commenter stated that
a recent study that used data from a
nationally representative survey (the
Medical Expenditures Panel Survey—
MEPS) found a change in real case-mix
between 2000 and 2007.
Response: We thank the commenter
for the comments. However, we note
that the MEPs analysis appears to be
based on all Medicare beneficiaries, not
just the subset of HH patients. Home
health users are less than 10 percent of
the fee for service enrolled Medicare
population, so it is not certain that the
MEPS study of the entire Medicare
population is relevant to the question of
worsening health status of HH users.
Comment: Commenters stated that
CMS should suspend or drop case-mix
reductions because the data used to
determine the reductions do not
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recognize real increases in severity due
to earlier and sicker hospital discharges.
Response: While we recognize that
average lengths of stay in acute care are
in decline, our analysis shows that
agencies are, in fact, caring for fewer,
not more, post-acute patients. Since
2001, the average length of stay in acute
care preceding HH has declined by
about one day, from 7 days to 6 days.
However, agencies are caring for fewer
highly acute patients in their caseloads.
The proportion of non-LUPA episodes
in which the patient went from acute
care directly to HH within 14 days of
acute hospital discharge declined
substantially between 2001 and 2008,
from 32 percent to 23 percent. In
addition, the median acute hospital
length of stay for these non-LUPA
episodes with a 14-day lookback period
has remained unchanged at 5 days since
2002 (see Table 1B, 50th percentile).
Since 2005, the distribution has been
stable, except for a 1-day shortening of
lengths of stay at the 5th, 80th, and 99th
percentiles. We believe the declining
prevalence of recent acute discharges is
due in part to more patients incurring
recertifications after admission to HH
care, and due to more patients entering
care from the community. The
shortening lengths of stay at the right
tail (high percentiles) of the distribution
may reflect changing utilization of longterm-care hospitals during recent years.
The conclusion we draw from these data
is that while patients on average have
shorter hospital stays, agencies are also
facing a smaller proportion of HH
episodes in which the patient has been
acutely ill in the very recent past. Also,
the detailed data on the distribution of
stay lengths suggest that for the most
part lengths of stay for such patients
remained stable through 2008,
particularly since around 2005.
TABLE 1B—PERCENTILES OF ACUTE HOSPITAL LENGTH OF STAY (DAYS)
[2001–2008]
Year
2001
2002
2003
2004
2005
2006
2007
2008
5th
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
10th
2
2
2
2
2
1
1
1
20th
2
2
2
2
2
2
2
2
30th
3
3
3
3
3
3
3
3
40th
4
4
4
4
3
3
3
3
50th
5
5
4
4
4
4
4
4
60th
6
5
5
5
5
5
5
5
70th
7
6
6
6
6
6
6
6
80th
8
8
8
7
7
7
7
7
10
10
10
9
9
9
9
8
90th
14
14
13
13
12
12
12
12
99th
32
31
30
29
28
28
27
25
emcdonald on DSK2BSOYB1PROD with RULES2
Note: Based on a 10 percent random beneficiary sample of FFS HH users; excludes LUPA episodes and includes only episodes where acute
hospital discharge occurred within 14 days of the from-date of the 60-day episode claim and the patient’s first destination post-discharge under
Part A was HH care.
Furthermore, we think that acuity of
patients has been increasingly mitigated
by lengthening post-acute stays for the
substantial number of HH patients who
use residential post-acute care (PAC)
prior to an episode. Our data show that
patients who enter residential PAC
before HH admission have experienced
increasing lengths of stay in PAC since
2001. Using a 10 percent random
beneficiary sample, we computed the
total days of stay (including both acute
and PAC days) for HH episodes with
common patterns of pre-admission
utilization during the 60 days preceding
the beginning of the episode. We
included patients whose last stay was
acute, or whose next-to-last stay was
acute with a follow-on residential PAC
stay, or whose third from last stay was
acute followed by two PAC stays. These
common patterns accounted for 55
percent of the initial episodes in 2001
and 42 percent in 2008. We found that
total days of stay during the 60 days
leading up to the episode averaged 12.6
days in 2001, and rose to 12.8 days in
2008. This small change in total days of
stay during a period when acute LOS
was declining was due to increasing
lengths of stay in residential PAC for
these patients. For example, within the
30 days before admission, average
length of stay in the PAC setting for
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episodes preceded by an acute stay that
was the next-to-last stay, and where the
PAC stay was the very last stay before
the claim-from date, increased from 12.7
to 14.3 days. Our interpretation of these
statistics is that patient acuity has been
increasingly mitigated by longer postacute stays for the substantial number of
HH patients that use residential PAC
prior to the start of a HH episode.
Patient acuity also was mitigated by
growing numbers of HH recertifications.
Comment: A commenter stated the
data and analysis we used to measure
real case-mix change do not recognize
that technology improvements in recent
years enable patients with more
complex conditions to be cared for at
home.
Response: We appreciate this
comment but possess limited
information to evaluate it. The data we
do have, from OASIS, suggest that
episodes for patients using
technological treatments at home are not
increasing. OASIS data show that the
proportion of episodes involving enteral
nutrition has declined from 2.9 percent
to 1.6 percent between 2001 and 2008;
the proportion of episodes involving
intravenous therapy or infusion therapy
has stayed stable at around 2.2 percent;
and the proportion of episodes
involving parenteral nutrition remains
at 0.2 percent or less during that period.
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The proportion of episodes with none of
those treatments has increased from
94.8 percent to 96.2 percent. These data
are inconsistent with the commenter’s
assertion, but we solicit commenters to
provide us in the future with other types
of reliable data on this aspect of patient
case-mix.
Comment: Many commenters cited
improvements in the accuracy of OASIS
coding which could more precisely
measure patient severity as a reason
why we should drop its proposal to
address nominal case-mix growth by
reducing payments.
Response: Comments referencing
coding improvements, such as
increasing accuracy, do not recognize
that such improvements are an
inappropriate basis for payment.
Measurable changes in patient severity
and patient need are an appropriate
basis for changes in payment. Our
analysis continues to find only small
changes in patient severity and need.
Comment: Commenters stated that the
increase in case-mix is due to the HHA’s
diligence in ensuring proper coding;
CMS’s implementation of payment
reductions would therefore penalize
HHAs for proper coding, while the
agencies who were not ethical or
diligent in their coding would not be
affected as much. Furthermore, a
commenter suggested that part of the
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‘‘nominal’’ case-mix changes were due to
HHAs’ past failures to code properly.
The commenter stated that when the HH
PPS system was first implemented in
2000, HHAs undercoded in a manner
that generated insufficient resources to
adequately care for the patient. After
modifications were made to the HH PPS
system in 2008, coding was still not
adequate for the patient. The commenter
stated that, for these reasons, the
baseline average case-mix is much lower
than the actual value.
Response: We agree with the
commenter’s explanation of previous
undercoding as a cause of nominal casemix growth. Over the years, we have
issued and revised instructions for
OASIS to reinforce the importance of
complete and accurate coding. As we
have stated in previous regulations,
however, Medicare should not
inappropriately make greater
reimbursements for a patient population
whose level of severity has changed
relatively little over the years,
notwithstanding more-comprehensive
documentation of the health status of
these patients.
Comment: A commenter stated that
much of the increase in case-mix
weights is due to HHAs complying with
Medicare instructions regarding patient
coding consistent with the 2008 version
of the HH PPS.
Response: This comment is difficult
to address because the commenter does
not cite specifically which documents
constitute CMS-issued Medicare
instructions ‘‘consistent with the 2008
version of the HH PPS.’’ Nor does the
comment explain how the increase in
case-mix weights was driven by such
CMS instructions. However, we believe
our release in late 2008 of a revision of
Attachment D of the OASIS Instruction
Manual would not have had the effect
suggested by the comment. (Attachment
D was intended to provide guidance on
diagnosis reporting and coding in the
context of the HH PPS.) First,
Attachment D reiterated traditional CMS
guidance about how to select diagnoses
in home health. Attachment D did not
deviate from the fundamental and
longstanding instruction that reported
diagnoses must be relevant to the
treatment plan and the progress or
outcome of care. Second, Attachment
D’s release late in the year suggests it
would not have had much impact on the
2008 data.
Comment: We received a number of
comments stating that HH patients now
have more complex conditions than
previous populations of HH patients
and that such patients previously would
have been referred to health care
facilities, but are now being cared for at
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home. Moreover, the commenters stated
that other healthcare settings have
developed stricter admission
requirements, thereby increasing the
number of HHA patients with high
severity levels. One commenter cited as
evidence diversion of patients to home
care from inpatient rehabilitation
facilities due to the CMS 60 percent rule
and skilled nursing facilities’ (SNFs’)
technology increases. The commenters
point to such changes as evidence that
policy incentives favor the home setting
over institutional care, and therefore,
case-mix increases are warranted.
Response: We appreciate the
comment, but we have little information
with which to evaluate the claim
regarding diversion to the home care
setting. Possibly relevant is that the
proportion of initial non-LUPA episodes
preceded by acute care within the
previous 60 days has declined between
2001 and 2008, from 70.0 percent to
62.7 percent. This indicates more
patients are being admitted from noninstitutional settings, for example, the
community. However, our data do not
indicate whether the patients coming
into home care without recent care in a
Part A setting were diverted from
entering such settings in favor of homebased care. Post-acute institutional
utilization data perhaps consistent with
the comment suggest a decline in
inpatient rehabilitation facilities (IRFs)
as a source of HH patients, but this
decline may have been partly offset by
an increase in SNF utilization as a
source. For example, the proportion of
initial episodes preceded by an IRF stay
that ended sometime during the 30 days
before HH admission suddenly declined
by more than a percentage point in 2005
and declined another 1.5 percentage
points by 2008, while the percentage
preceded by a SNF stay increased half
a percentage point in 2005 and
increased another 0.4 percentage points
by 2008 (data based on a 10 percent
beneficiary sample of initial, non-LUPA
episodes). Furthermore, the fact that
acute stays, which normally precede
stays in institutional PAC settings, are
decreasing in the stay histories of HH
patients is inconsistent with the idea
that the reduction in IRF stay histories
is a sign that more patients are coming
to HH as a result of diversion from IRF
care.
Comment: Commenters stated that the
implementation of the payment
reductions should be delayed until the
validity of data and methods used to
calculate the payment reduction can be
verified.
Response: The real case-mix
prediction model and its application
account for changes in the HH patient
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population by quantifying the
relationship between patient
demographic and clinical characteristics
and case-mix. The relationships in
conjunction with updated measures of
patient characteristics are used to
quantify real case-mix change. The
characteristics in the model include
proxy measures for severity, including a
variety of measures, namely,
demographic variables, hospital
expenditures, expenditures on other
Part A services, Part A utilization
measures, living situation, type of
hospital stay, severity of illness during
the stay, and risk of mortality during the
stay. Measurable changes in patient
severity and patient need, factors
mentioned by commenters, are an
appropriate basis for changes in
payment. Our model of real case-mix
change has attempted to capture such
increases.
We recognize that models are
potentially limited in their ability to
pick up more subtle changes in a patient
population such as those alluded to by
various commenters. Yet in previous
regulations, we presented additional
types of data suggestive of only minor
change in the population admitted to
HH, and very large changes in case-mix
indices over a short period. We
included among these pieces of
evidence information about the
declining proportion of HH episodes
associated with a recent acute stay for
hip fracture, congestive heart failure,
stroke, and hip replacement, which are
four situations often associated with
high severity and high resource
intensity. We found declining shares for
these types of episodes as of 2005 (72
FR 49762, 49833 [August 2007]). We
presented information showing that
resource use did not increase along with
billed case-mix (72 FR 49833); stable
resource use data suggest that patients
were not more in need of services over
time, notwithstanding the rising billed
case-mix weights that suggested they
would be. We also analyzed changes in
OASIS item guidance that clarified
definitions and could have led to
progress in coding practice (72 FR
25356, 25359 [May 2007]). We reported
rates of OASIS conditions for the year
before the beginning of the HH PPS and
2003, and found some scattered small
changes indicative of worsening severity
but no dramatic changes commensurate
with the increase in case-mix weights
(72 FR 25359). In our discussion, we
cited specific instances where agencies’
changing understanding of coding could
have contributed to the adverse changes.
However, as previously stated, Medicare
payments should be based on patient
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level of severity, and not on coding
practices.
In the July 2010 proposed rule, we
identified a very large, sudden 1 year
change (+0.0533) in the average casemix weight by comparing a 2007 sample
that we assigned to case-mix groups
using the new 153-group system and a
2008 sample grouped under the same
system. It is unlikely that the patient
population suddenly worsened in
severity to cause an increase of 0.0533
in the average case-mix weight in a
single year. Furthermore, we concluded
that the large change was not due to our
use of the new, 153-group case-mix
algorithm in 2008, because when we
applied the previous case-mix system
and the new system to a sample of 2007
claims, the average weight differed very
little (the difference was 0.0054). That
is, the algorithms in the previous and
new case-mix systems provided highly
similar case-mix weights on the sample
of 2007 claims. We further examined the
diagnosis coding on OASIS assessments
linked to the 20 percent claims sample
and found a large increase between 2007
and 2008 in the reporting of secondary
diagnosis codes (see 75 FR 43242 [July
23, 2010]). The use of secondary
diagnosis codes in the case-mix
algorithm was introduced in 2008 as
part of the new case-mix system.
We are not delaying the CY 2011
payment reduction because we consider
these various analyses to be strong
evidence that agencies changed coding
practice markedly when faced with the
new case-mix system in October 2000
and when faced with the refined one in
January 2008. The conclusions we
reached from the available evidence
were that a small amount of real casemix change has occurred; our model
measures this amount to be 10.07
percent of the total change in the
average weight since the 12-month
period ending September 30, 2000. The
remainder of the total change resulted
from sources of nominal case-mix
change as discussed elsewhere in this
preamble. These sources include
improvements in coding, changes in
therapy prescriptions in response to
payment incentives, and changes in
such elements of the system as OASIS
item definitions and coding guidelines.
However, as stated elsewhere in this
preamble, we are not finalizing the
proposed reduction for CY 2012
pending further study relating to the
measurement of real and nominal casemix change.
Comment: Commenters stated that we
should change our methodology so that
coding and documentation, and not
therapy utilization, are the only factors
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used in calculating ‘‘nominal’’ case-mix
changes.
Response: We thank the commenters
for their suggestion. However, the model
we use is intended to analyze changes
in real case-mix over time and does not
distinguish whether these changes are
due to increases in therapy use or other
factors mentioned by the commenter.
We do not believe that it would be
appropriate to include utilizationrelated variables such as the number of
therapy visits as variables in the model
predicting real case-mix change. In
addition, the goal of this analysis was to
examine changes in measures of patient
acuity that are not affected by any
changes in provider coding practices.
Comment: Commenters stated that we
should eliminate the proposed payment
reductions and rather ‘‘conduct targeted
claims review and deny payment for
claims where the case-mix weight is not
supported by the plan of care.’’
Response: While we appreciate the
commenters’ suggestion, we cannot act
on it, because our resources are not
sufficient to conduct claims review on
a scale that would be required to
counteract the broad-based uptrend in
case-mix weights.
Comment: Other commenters stated
that CMS decrease the magnitude of the
proposed payment reductions.
Response: We have amended the
proposal that would have implemented
two successive years of payment
reductions, with each year’s reduction
at 3.79 percent. Instead we are finalizing
in this rule only the first year’s
reduction (for CY 2011) while we study
additional case-mix data, and methods
to incorporate such data, into our
methodology for measuring real vs.
nominal case-mix change. In the CY
2012 proposed rule, we will make
proposals concerning any payment
reduction for CY 2012 based on results
of those studies and based on claims
samples updated through CY 2009. In
previous rules, we have stated our
intention to incorporate additional types
of data, such as Part B data, into our
methodology. Efforts so far have been
inhibited by problems of data adequacy.
In the coming year, we intend to draw
on more resources and expertise than
we have in the past in order to move
forward in completing the examination
of additional kinds of data for
measuring real vs. nominal case-mix
change. As we have stated elsewhere in
this regulation, the various types of
information and data pointing to the
conclusion that nominal case-mix
change has been responsible for most of
the case-mix growth go beyond the
model predicting real case-mix. Much of
that extra information cannot be
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converted into a quantifiable measure,
but it is nevertheless very significant in
explaining nominal case-mix growth.
Comment: Commenters stated that we
should eliminate the case-mix
reductions altogether and find other
methods to prevent upcoding and
‘‘manipulation of therapy and co-morbid
condition factors.’’
Response: We appreciate the
commenter’s suggestion. As stated
elsewhere in this preamble, the payment
reductions we proposed were to
compensate for past nominal change in
case-mix weights that resulted from
changed coding practices and/or
instructions and behavioral changes
among agencies, such as changes in
therapy visits prescribed. One approach
addressing therapy factors would be to
conduct medical necessity evaluations
during episodes. An approach to
limiting a change in comorbid-condition
coding exacerbated by a change in
disease definition would be to eliminate
hypertension from the case-mix system.
We believe these are two proposals that
capture the spirit of the commenters’
suggestion, but in both instances, we
received many comments in opposition.
However, we welcome suggestions of
other policies that can prevent upcoding
and manipulation of case-mix measures.
Comment: Commenters stated that we
should suspend or drop case-mix
adjustments because adjustment should
instead focus on case-mix groups with
high weights due to therapy.
Response: The 2008 case-mix model’s
four-equation structure incorporated a
procedure that decelerated payments as
therapy visits per episode increase. We
plan to recalibrate the case-mix weights
in the coming year, and in so doing we
will examine our policy of imposing
within the case-mix model this
deceleration in payment increases. Such
examination could lead to an approach
suggested by the commenter, were we to
more aggressively impose the
deceleration. For 2011, we are
proposing to maintain the set of casemix weights we issued in 2008.
Comment: Similarly, commenters
stated that we should ‘‘target agencies
with excessive therapy usage’’ instead of
implementing the proposed payment
reductions.
Response: We have not conducted an
analysis to identify agencies with
excessive therapy usage. We believe that
what constitutes excessive therapy must
be judged in view of the patient’s need
during the episode. It is impossible to
conduct an analysis that takes the
amount of individual need into account
based on the information we have; in
fact, that is the reason we implemented
therapy thresholds in the first place: A
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shortage of information on the OASIS
sufficient to predict the amount of
therapy needed by the patient. What we
do have is strong evidence that in
general therapy prescriptions changed
dramatically under the HH PPS, in
response to payment incentives. These
prescriptions changed again with the
implementation of the revisions to the
HH PPS case-mix system in 2008;
notably, between 2007 and 2008, we
observed a 3-percentage point increase
in the percent of episodes with 14 or
more therapy visits. Such behavioral
change was part of the nominal change
causing expenditures that we are now
recovering with the case-mix reductions
to the rates.
Furthermore, even if agencies with
excessive therapy usage were
identifiable in an administratively
feasible manner, a separate set of
concerns relates to the effect on
beneficiaries from targeting agencies in
the way suggested by the commenters.
We are concerned that a policy of
targeting agencies with excessive
therapy usage might unfairly penalize
certain patients. For instance, even in an
agency that pads the therapy
prescription to reach a certain
threshold, there will likely be some
patients who need all the therapy visits
prescribed. A payment reduction
limited to certain agencies is likely to
unfairly penalize some of the agency’s
patients. In addition, as previously
stated, we believe that nominal case-mix
change has been widespread and that
therefore overpayments were
widespread as well.
Comment: Commenters stated that we
should suspend or drop case-mix
reductions in favor of the approach in
S.2181/H.R. 3865 (110th Congress),
which involved working with the HH
industry to develop criteria and
evaluating a medical records sample to
determine reductions, rather than
relying on hypothetical extrapolations.
Another commenter mentioned that the
Home Health Care Access Protection
Act (S. 3315/H.R. 5803) was introduced
to ‘‘establish a more reliable and
transparent process for CMS to follow in
evaluating Medicare payments for home
health services.’’ The commenter asked
if CMS would be willing to cosponsor
this legislation.
Response: We intend to work with
representatives of the HH industry as we
pursue a review over the coming year of
the data and methods for measuring real
case-mix change. Theoretically, a
medical records sample might work, but
as a practical matter, we strongly
suspect it might not work. It is unlikely
that we could finance the collection of
samples large enough to produce
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reliable results. It is expensive to
abstract medical records, and we would
need a sizable sample of records from
the IPS period and from a follow-up
year (for example, 2009). Based on our
experience in a context involving the
retrieval of years-old records, it is not
likely that we could find enough records
to constitute a valid broad-based
sample. The procedure would have
nurses group them into a case-mix
group, and compare the results with
those from a similar procedure
performed on recent records. Additional
potential problems with using medical
records include the strong possibility
that records would have insufficient
information to allow assignments for the
Activities of Daily Living (ADL) items of
the case-mix system, have insufficient
information to enable independent
staging of pressure ulcers, and other
kinds of underreporting. It is possible
that this procedure might not return the
findings that the proponents suggest it
would, because the nominal case-mix
change problem partly results from
reporting practices that have changed
through time from a state of
underreporting to a state of more
complete reporting. Therefore, one
would expect that the source records
would likely reflect underreporting in
the early years, just as the OASIS
reflected underreporting in the early
years.
Comment: One commenter stated that
detailed information about the method
to calculate the baseline values was not
released to the public. Commenters
questioned the validity of the 2000 data
used to calculate the baseline.
Commenters stated that in 2000, there
was a limited amount of OASIS data
and the data submitted might not have
been completely correct. One
commenter expanded upon this concept
by stating that ‘‘a consistent, largely
reliable database of information from
submissions of the OASIS form was
most likely not achieved until sometime
during 2003’’. Commenters stated that
initially extensive education and
training was needed in order to ensure
reliable OASIS data. In addition,
commenters stated that since Abt
Associates was only able to use 313,447
episodes to calculate the base, there
were not enough data to ensure that the
base was correct, and therefore, ‘‘the
final period of IPS should not have been
used as a ‘‘base’’ to measure anything.’’
Response: In our May 2007 proposed
rule and our August 2007 final rule, we
described the IPS samples and PPS
samples that were used to calculate
case-mix change. We remind the
commenter that 313,447 observations is
an extremely large sample by statistical
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standards, and that agencies began
collecting OASIS data in 1999,
following issuance of a series of
regulations beginning on January 25,
1999 (64 FR 3764). Most of the data we
used for the baseline period come from
the first 3 quarters of the year 2000—
months after collection was mandated to
begin in August 1999. By 2000, the vast
majority of agencies were complying
with the reporting requirements. We
question the idea that agencies took
three more years to come up to speed
with OASIS. We believe the commenter
overstates the amount of training
needed to complete OASIS reliably. The
licensed personnel responsible for
assessing patients do not and should not
need all the extensive training implied
by the comment, because assessment is
part of the foundation of their training
and professional skill. Indirect evidence
that the data from the early years of the
HH PPS were sufficiently reliable comes
from model validation analysis we
conducted during that period.
Validation of the 80-group model on a
large 19-month claims sample ending
June 2002 (N = 469,010 claims linked to
OASIS) showed that the goodness-of-fit
of the model was comparable to the fit
statistic from the original Abt Associates
case-mix sample (0.33 vs. 0.34),
notwithstanding that average total
resources per episode declined by 20
percent. That analysis also showed that
all but three variables in the scoring
system remained statistically
significant.
Comment: Commenters noted that
OASIS data from Outcome Concepts
Systems demonstrated increased patient
acuity from 2006–2008 as measured by
ADL and Instrumental Activities of
Daily Living (IADL) assessments of
decreasing functional capabilities of HH
patients. OASIS data demonstrated a
‘‘large increase’’ in acuity as measured
by changes in clinical conditions, the
number of patients requiring IV therapy,
parenteral nutrition, those that have
urinary tract infections at the start of
care and those with increased inability
to manage oral and injectable
medications; these commenters noted
that OASIS measures were not likely to
be ‘‘upcoded’’ to secure higher
reimbursement as none had a direct or
indirect impact on the level of payment
under HH PPS. Further, the decrease in
functional capabilities could have been
easily correlated with increase in the
use of therapy services as both physical
and occupational therapists directly
address the ADL incapacities that are
the focus of these OASIS findings. The
commenter referred to reports on the
July 23, 2010, Proposed Rule
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commissioned by the Home Health
Advocacy Coalition and the National
Association for Home Health and
Hospice, saying both documents
indicate ‘‘non-case-mix related OASIS
items, such as grooming and light meal
preparation have shown increasing
functional limitations among home
health patients.’’
Response: We believe the commenter
is in error in stating that intravenous
therapy and parenteral nutrition are not
used in the case-mix system. Another
inaccuracy in this comment pertains to
the cited changes in the frequency of
these technological treatments at home,
which in fact are not increasing. A large,
random sample of OASIS data linked to
claims shows that the proportion of
episodes involving intravenous therapy
or infusion therapy has remained stable
at around 2.2 percent and the
proportion of episodes involving
parenteral nutrition remains at 0.2
percent or less during that period. We
are reluctant to use OASIS data to
analyze changes in real case-mix
because OASIS measures reflect changes
in coding practices and payment
incentives including quality
measurement incentives, all of which
are not related to real changes in
patients’ acuity. We are also concerned
that incentives could lead to reports of
patient function—whether or not
particular function-related items are
used in the case-mix assignment—that
are consistent with the therapy visits
planned. Unfortunately, this problem
potentially limits the usefulness of noncase-mix items. We believe that
independent measures are the best way
to ensure the reliability of our real casemix methodology. We plan to try to
identify independent measures, beyond
the independent measures we are
currently using in our methodology, as
we go forward.
Comment: A commenter stated the
case-mix change analysis is flawed in
that it relies on hospital DRG data,
whereas more than half of Medicare HH
patients are admitted to care from a
setting other than a hospital, and if they
were in a hospital, the HH admission
followed much later.
Response: We disagree that the utility
of the hospital information in the casemix change analysis is so limited.
Regardless of whether the patient came
directly from a non-hospital-setting (for
example, home or a post-acute
institutional stay), information from a
hospital stay preceding HH is typically
relevant to the type of patient being seen
by the HHA, and thus can provide
information about the PPS case-mix
measure for the HH episode. A recent
hospitalization, whether or not there is
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an intervening period spent in some
other setting before HH admission, is
common before admission to home
health. Data from a 10 percent random
beneficiary sample of HH users indicate
that a hospitalization history for new
admissions is far more common than the
comment may suggest. In 2008, 45.3
percent of patients admitted to home
care for a non-LUPA episode had an
acute stay within the previous 14 days;
56.1 percent had an acute stay within
the previous 30 days; 60.3 percent had
an acute stay within the previous 45
days; and 62.7 percent had an acute stay
within the previous 60 days. We could
have restricted the real case-mix change
analysis to new admissions to home
health, but because we received many
questions about the completeness of the
information to be obtained from such an
approach, we decided to use all 60-day
episodes in the analysis. We believe
using all 60-day episodes in the analysis
is reasonable, since a majority of new
admissions to HH complete their stay in
HH within a 60-day episode.
Furthermore, non-initial episodes,
though they are less than half of
episodes in our analysis, are not devoid
of recent hospital information. When we
look at all new HH admissions, we find
that about 15 percent are hospitalized
within 30 days of admission (that is,
within the first 30 days of the first
episode), with the risk of hospitalization
rising beyond the 30th day. Many of
these hospitalized patients return to HH
after discharge, making data for
returnees available for our analysis of
the acute stay history. While we do not
have information specifically about the
hospitalization risk of the new
admissions who go on to recertification
episodes, it seems reasonable to infer
that they have risks similar to the
overall average 30 day hospitalization
rate of 15 percent. The Abt Associates
case-mix change report (‘‘Analysis of
2000–2008 Case-mix Change,’’ July
2010, link at https://www.cms.gov/
center/hha.asp) indicates that about 90
percent of the episodes have a
hospitalization history in the data (p. 6),
looking back a maximum of 4 years.
However, from the information we show
here about the likelihood of a hospital
stay before and after home health,
relatively few of the hospital stays
contributing information are as old as 4
years. We also note that the remaining
10 percent of episodes are not dropped
from the analysis; these episodes
contribute information for the model,
specifically, demographic information
and various proxy measures derived
from Part A utilization and expenditure
data.
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Comment: Commenters suggested that
CMS should also recognize that HH
patients are often treated for conditions
other than the primary reason for their
hospitalization. Furthermore,
commenters stated that the primary
reason for HH care may be different
from the primary reason why a person
was admitted into the hospital.
Therefore, commenters stated that the
DRGs used in the real case-mix
prediction model may not be relevant to
the patient’s condition in the HH
setting.
Response: We thank the commenters
for their input. However, we would like
to remind commenters that the real
case-mix prediction model is not
limited to diagnoses from inpatient
claims. The model also takes into
account demographic factors, as well as
utilization indicators of health status.
Moreover, the model measures the
relationship between these factors and
case-mix.
Comment: Some commenters stated
that payment rate reductions due to
case-mix weight changes are not
warranted because Medicare
expenditures on HH are well within
budgeted levels, thereby demonstrating
that aggregate spending has not
increased enough to permit CMS to
exercise its authority to adjust payment
rates. Commenters cited budget
projections of the Congressional Budget
Office (CBO). Another commenter stated
while therapy services for HH patients
have increased in volume since the start
of the HH PPS in 2000, patient
outcomes have improved and Medicare
spending per patient and in the
aggregate overall has stayed well below
projections by the CBO. Some
commenters stated that payment
reductions in HH will lead to more
institutional care, for example, by
leading to increases in hospital
readmissions of post-acute patients.
Response: A CBO projection table
shown in one of these comments
indicated that, based on projections of
March 2004, spending has exceeded
projections in 3 of the 5 succeeding
years. We have no statutory authority to
consider the relationship of CBO
projections to HH outlays when setting
the HH PPS payment rates. The
Secretary’s authority to respond to
nominal coding change is set out at
section 1895(b)(3)(B)(iv) of the Act.
There is no evidence that improvement
in HH patient outcomes is related to the
level of payments achieved through
nominal case-mix change. Effects of
payment reductions on access and
patient outcomes are worthy of study,
using carefully designed research. We
are aware of the challenges of
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conducting conclusive research in this
area, in part because other policy
changes affecting the study question
may co-occur. We have noted elsewhere
in this preamble that we intend to
request that the Office of the Inspector
General resume investigations of the
access impacts of payment reductions.
Comment: A commenter stated that a
typical case-mix weight change
adjustment in other sectors may bring a
reduction in profit margins only,
whereas in home health the adjustment
occurs where the higher payments from
increased case-mix weights are offset by
increased costs.
Response: Analysis of profit margins
indicates that they remain high among
HHAs. For example, Medicare margins
were 17.4 percent in 2008. This
situation suggests that higher payments
are not necessarily being offset by
increased costs. In March 2010, MedPac
estimated that Medicare margins will be
13.7 percent in 2011, taking into
account the then-expected payment
reduction of 2.71 percent to account for
nominal case-mix change (MedPac,
Report to the Congress: Medicare
Payment Policy, March 2010). Our
estimates suggest aggregate Medicare
profit margins in HH will remain in
double digits in 2011 under the
payment policies proposed in the July
23, 2010, proposed rule.
Comment: Commenters stated that
therapy utilization is a coding
adjustment that accompanies not only
an increase in reimbursement but also
an increase in provider costs, implying
that a rate reduction related to increased
costs is inappropriate.
Response: We believe that the goal of
the Medicare program is to ensure that
beneficiaries receive the right care at the
right time. The evolution of patterns of
therapy utilization since the PPS began
leaves doubt that appropriate care has
been provided. In the CY 2008 proposed
regulation (72 FR 25356) we described
a shift in the distribution of therapy
visits per episode under the HH PPS
that caused two peaks: One below the
therapy threshold of 10 therapy visits
and the other in the 10 to 13-visit range.
Before the HH PPS, the distribution had
one peak, at 5 to 7 therapy visits, well
below the 10-visit therapy threshold in
use prior to the 2008 refinements to the
HH PPS. Table 2 shows the distribution
of episodes (LUPA and non-LUPA)
changed again with the implementation
of the 153-group case-mix system and
its revised set of thresholds and therapy
steps. At the new 7-visit step (7 to 9
visits) there was a sudden 50 percent
increase in the proportion of episodes,
and at the new 14-visit therapy
threshold, there was a 25 percent
increase in the proportion of episodes.
One commenter, in writing about the
questionable prescription of therapy
treatment, stated that certain agencies
have habitually provided therapy to
patients whose natural course of
recuperation would have been the same
regardless of receipt of therapy. We also
note that we implemented a declining
payment with each added therapy visit
with the 2008 refined case-mix system,
with the intent to deter inappropriate
padding of therapy prescriptions to
higher and higher numbers of visits, as
we added new thresholds above 10
visits. However, the pliability of therapy
prescriptions, the continued growth in
the proportion of episodes utilizing
therapy, and the 25 percent increase in
the proportion of episodes with high
numbers of therapy visits (14 or more)
may be evidence that increased costs are
more than offset by the increased
payment associated with therapy.
Therefore, it is not certain that a rate
reduction related to increased costs is
inappropriate.
TABLE 2—DISTRIBUTION OF HOME HEALTH EPISODES ACCORDING TO NUMBER OF THERAPY VISITS
[2002–2008]
2001
(%)
Number of therapy visits
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None .................................................................................................
1 to 5 ................................................................................................
6 .......................................................................................................
7 to 9 ................................................................................................
10 to 13 ............................................................................................
14+ ...................................................................................................
Comment: A commenter stated that
the increase in case-mix due to
increased therapy services should count
towards the ‘‘real’’ case-mix changes, not
towards the ‘‘nominal’’ case-mix
changes. The commenter thought that as
long as the agency provides therapy, the
changes in case-mix due to increased
therapy services should be considered
‘‘real.’’
Response: We based our nominal
change estimate on beneficiary
characteristics information, which when
applied to the prediction model for real
case-mix, to account for whatever
changes in patient severity that have
occurred since the IPS baseline. The
remainder of the change in the national
average case-mix weight is classified as
nominal. We have not netted out from
our estimate of nominal case-mix
change any increases in the weights due
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2002
(%)
54
14
3
6
10
12
52
15
3
6
11
12
2003
(%)
51
15
3
6
13
12
to additional therapy utilization,
because utilization is an aspect of the
case-mix system that is under the
control of providers, and therefore, is
not necessarily a reflection of changes in
patient severity, especially in view of
the fact that our use of the real case-mix
change model accounts for changes in
patient severity. Furthermore, the
evolution of therapy utilization under
the HH PPS suggests that some of the
therapy provision under the HH PPS has
been subject to financially driven
decision-making and as such, it is akin
to nominal case-mix change, so we have
classified it with nominal change.
Comment: A commenter stated the
real case-mix change analysis omits
consideration of increased therapy
needs in the population. Other
commenters stated that therapy use
changes were not explained in the
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2004
(%)
50
15
3
6
14
12
2005
(%)
50
15
3
6
14
12
2006
(%)
50
15
3
6
15
12
2007
(%)
50
14
3
6
15
12
2008
(%)
49
14
3
9
10
15
model and that CMS admitted that it
could not explain the correct amount of
therapy expected for patients. The
commenter stated CMS should use
alternative variables that would be more
indicative of the changes in therapy use.
Response: The models were intended
to analyze changes in case-mix over
time and do not distinguish whether
these changes are due to increases in
therapy use or other factors. We do not
believe that it would be appropriate to
include utilization-related variables,
such as the number of therapy visits, as
predictors in the model, as such,
variables are provider-determined. In
addition, the goal of these analyses was
not to develop refinements to the
payment system but rather to examine
changes in measures of patient acuity
that are not affected by any changes in
provider coding practices. CMS has
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access to the claims histories and other
administrative data for patients in our
samples, and we welcome suggestions
about how to better use these resources
in finding alternative variables more
indicative of the need for therapy. Such
proposals must recognize that the
desirability of any proposed alternative
data depends on whether the data
generation process involves HH
providers.
Comment: A commenter stated that
fewer therapy services are being
provided in other care settings and
therefore, the increases in therapy usage
are due to patients’ increased need for
therapy services in the HH setting.
Response: We have no information
suggesting that fewer therapy services
are being provided in other care
settings. In the SNF setting, more
therapy is being provided to SNF
patients than used to be the case. This
is indicated by the increased share of
SNF days for therapy RUG–III groups;
the share grew from 75 percent to 85
percent between 2000 and 2006.
MedPac has documented increases in
rehabilitation intensity in SNFs since
2002 (MedPac, Report to the Congress,
Medicare Payment Policy, March 2010).
For patients who go on to HH from Part
A institutional settings, we have no
evidence of less therapy utilization in
prior settings. We have evidence to the
contrary. For example, total billed
charges for therapy from all previous
Part A settings within the 14 days before
HH admission nearly tripled, from an
average of $1,154 (2001) per person with
any Part A discharge to $2,952 (2008).
Total billed charges for therapy
increased from $2,068 in 2001 to $3,680
in 2008 per person with any prior Part
A stay involving therapy.
Comment: A commenter suggested
that CMS ‘‘analyze case-mix weight
changes based on data beginning in
2005’’ and ‘‘analyze case-mix weight
changes for 2008 to current to see how
much increase occurred in more recent
years.’’ Furthermore, the commenter
recommended that CMS ‘‘use national
benchmarking companies for data if
CMS does not have data yet available.’’
Response: We will be turning to
analysis of 2009 data later this year.
Unfortunately, the time it takes for a
complete year of data to arrive and the
added time of cleaning, processing,
summarizing, and linking the data
currently preclude using the data for the
analysis in this final rule. We have
concerns that data from benchmarking
services would not be nationally
representative. Therefore, we intend to
use random samples drawn from our
own administrative data.
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Comment: A commenter believes that
the model fails to account for any
changes in HHA behavior related to
patient populations served. These
changes would include a marketing
effort targeted to increase the proportion
of patients who are high users of
therapy. The commenter also stated that
the post-acute care industry has
changed dramatically since the Abt
regressions were first designed. The
current use of administrative claims
data by Abt and CMS is inadequate, and
perhaps even counterproductive. This
practice sends the wrong signals as to
how HH and facility-based care should
be related as the Medicare program
moves toward an era of ‘‘bundled
payments’’ and other initiatives to
coordinate care across settings.
Response: We disagree with this
comment. The predictive model for real
case-mix was designed in 2007 and
includes a comprehensive set of
variables. The model looks at case-mix
change across a large sample of
providers, rather than considering
individual provider behavior. If the
characteristics of patients have changed
due to marketing efforts, this should
show up as changes in the mean values
of patient characteristics over time. For
example, the increase in knee
replacement patients since the baseline
year causes an increase in the predicted
case-mix weight. We will continue to
research ways to modify our models and
data for analyzing real case-mix change
over time. A challenge with using
OASIS items is that, for the most part,
OASIS items associated with case-mix
are already used in the grouper and thus
are not appropriate to use in the casemix change analyses (since changes in
case-mix over time may be due to
coding changes rather than changes in
severity).
Comment: Commenters stated that the
model is based on administrative data
rather than clinical data.
Response: The model only includes a
few variables that are derived from
OASIS assessments (measures of patient
living arrangement) because the OASIS
items can be affected by changes in
coding practices. It is not practical to
consider other types of HH clinical data
(for example, from medical charts) in
the model.
Comment: A commenter wrote that
the model relies too heavily on
assumptions and beliefs rather than
empirical evidence.
Response: We disagree with the
commenter. The prediction model for
real case-mix is an empirical model, the
findings of which are based entirely on
empirical evidence.
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Comment: A commenter stated CMS
should suspend nominal case-mixrelated payment reductions until it
develops an accurate and reliable model
to evaluate changes in case-mix weights
consistent with the whole nature of
patients served in HH care, not just
those discharged directly from
hospitals.
Response: The commenter does not
recognize that many variables in our
model are applicable to patients who
have not used hospitals recently.
Variables relating to demographic status
and PAC utilization are among the
model’s variables. Another set of the
model’s variables, used to describe the
nature of any previous hospital stay,
applies to many patients nonetheless,
because we searched the claims history
to find the last hospital stay that
occurred before the episode. We believe
that the model includes a rich set of
patient measures. Efforts will continue
to deploy more information in
evaluating changes in HH patients’
health characteristics. It is important to
note that the omission of any particular
variable is not enough to change
estimates of unpredicted case-mix
change. Variables must have different
prevalence rates in the initial and later
periods. If prevalence rates for such
variables were the same in both periods,
the effects would net out; in other
words, there would be no systematic
difference in the predicted case-mix
over time.
Comment: One commenter stated that
the ‘‘2008 additional case-mix ICD–9
codes and therapy four-equation model
logically results in increased case-mix
and contributes to the faulty foundation
of comparison with IPS and early PPS
data.’’
Response: We disagree with the
commenter. We performed our research
leading to the four-equation model
using an extremely large sample of
claims linked to OASIS assessments.
Using visit times by discipline reported
on the sample of claims, we studied the
relationship of the total of wageweighted visit times per 60-day claim to
patient characteristics as reported by
agencies on the assessments. The wageweighted minutes are the best measure
available of the cost burden of caring for
the patient, given his or her clinical
characteristics. This method essentially
replicated the original method we used
to develop the 80-group case-mix
system during the period before OASIS
was implemented and before per visit
line billing was required. A prototype of
OASIS was used at that time. The 2005
coding and reporting practices, as well
as the resource use patterns, were the
foundation of the 2008 refinements,
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along with our replication of the basic
analytic approach. We know of few
other methods comparable in their
ability to yield a fair and representative
case-mix model for national application.
Given the essential continuity in
approach, we fail to see how the 2008
refined model specifically is a reason
not to make comparisons with pre-PPS
and early PPS data. Our comparisons of
population and utilization
characteristics, which are the basis for
our prediction model of real case-mix,
do not involve use of the HH PPS casemix payment variables or the ICD–9
codes reported by agencies.
Comment: Commenters stated that the
Abt report on the real case-mix change
analysis (‘‘Analysis of 2000–2008 Casemix Change’’, July 2010, link at https://
www.cms.gov/center/hha.asp) does not
discuss what signs are consistent with
known relationships and, hence, is not
in a position to judge the signs of the
coefficients. In addition, commenters
stated that while Abt included variables
related to inpatient stays, the estimated
coefficients are not consistent with
expectations that ‘‘the coefficient for any
stay would be positive and the
coefficient for the number of days
would be negative.’’ The coefficient has
an opposite sign than what is expected.
Response: We thank the commenters
for their comments. However, our
purpose is to predict case-mix weights
using all available and relevant
administrative data, rather than to
isolate the impact of individual
variables. We have noted elsewhere that
many coefficients have signs as we
expect (Abt Associates 2008; CMS
1541–FC, FR August 29, 2007). Contrary
to what the commenter states, it is not
clear that a hospitalization would be
associated with higher case-mix; it may
be that community patients are more
clinically complex and have a higher
case-mix than those who are discharged
from a hospital to home health. This
result is consistent with the impact of
pre-admission location variables (from
OASIS item M0175) in the 80-group
case-mix model.
Comment: Abt does not perform any
multicollinearity diagnostic statistics or
consider the remedy of combining some
of the variables. The model uses a large
number of variables that do not have
much variation. The close interaction
among the variables ‘‘is likely to pose
problems with the prediction of the
dependent variables.’’
Response: Given the objectives of the
analysis, we are not particularly
concerned about redundancy among
variables. It is also important to note
that such redundancy, often called
multicollinearity, does not actually bias
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results and may only cause large
standard errors of the coefficients for
variables that are related to one another.
Standard errors are not used in our casemix change calculations. The Abt
Associates report described
improvement in the predictive power of
the model as each set of variables (for
example, APR–DRG variables) was
added beyond demographic variables
alone. The addition of Part A
expenditure variables, the last variable
set added to the model, led to little
improvement in predictive power, and
for that reason might be considered
redundant; however, their addition did
not change the essential results of the
analysis (Abt Associates, 2008), which
were that only a small proportion of the
case-mix growth could be attributed to
changes in patients’ characteristics.
Comment: Commenters stated that the
Abt models are unreliable because 40
percent of the top variables differ from
one model year to the next (original IPS
model and the model rebased to 2008
data), and 20 percent of the variables
change signs. Commenters also stated
that the model CMS uses to assess casemix weight changes should be at least
as accurate and reliable as the case-mix
adjustment model that it is assessing.
The current PPS case-mix model
reportedly originally had an R-squared
explanatory power of over 40 percent
while the case-mix weight change
assessment model falls far short of that
benchmark. Commenters stated that the
explanatory power of the models falls
46 percent from the original model to
the rebased model. The regression
model R-square dropped from 19
percent to 10 percent in the 2008
analysis. The R-square of the 80-group
HHRG model was at 0.21—much lower
than the R-square for the 153-group
HHRG model at 0.44. The commenter
stated this high R-square of the current
PPS case-mix model suggests that the
case-mix weight change regression
model analysis for 2008 should have
had a higher R-square. The decrease in
the R-square is ‘‘unclear and
unexplored.’’
Response: We thank commenters for
their comments. However, we disagree
that the difference in R-squares for the
two models indicates that the prediction
model for real case-mix is unreliable.
The nine top drivers of case-mix are the
same in both models, as are 15 of the
top 20. Most of the predicted case-mix
change results from the major ‘‘drivers’’
in the model, and, of the top 50 drivers
of case-mix change (which account for
more than 60 percent of the total
predicted change in the model), 37 have
the same sign in both models and the
correlation between the coefficients
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from the two regression models is 0.56.
Of the variables that changed signs,
most were not statistically significant.
We would expect some change over
time in the variables that are among the
top drivers of case-mix change, given
the large number of variables in the
model and the differing dependent
variables (the 80 case-mix weights for
the first model and the 153 case-mix
weights for the second model). With
regards to the 40 percent R-squared
explanatory power benchmark, given
that the goal of the case-mix change
analyses is to determine the extent to
which case-mix changes observed over
time are due to changes in patient acuity
or other factors (such as coding changes)
that are not observed in the model, we
do not believe that this is an appropriate
statistical performance benchmark for
the model.
The explanatory power of the current
HH PPS case-mix model is as high as it
is in large part because of the therapyrelated variables in the model (where a
direct measure of resource use is
included on the right-hand side of the
regression model). We do not believe
that it is appropriate to include these
types of variables in the case-mix
change model because they are provider
determined.
Comparing the statistical performance
of the two prediction models for real
case-mix is not really appropriate to
compare strictly the statistical
performance of the two models, given
that we had to drop the living
arrangement variable from the second
model and that the dependent variable
for each model is a different set of casemix weights. We also note that a
possible contributor to the lower Rsquare for the second model is the large
amount of nominal case-mix change that
occurred between 2000 and 2008.
Changes in coding practice and
resulting assignment of case-mix
weights could have led to a situation
where the predictor variables in the
prediction model for real case-mix
collectively have less ability to predict
the weights than when the variables
were first used with the data from the
last year of IPS (2000) to predict the
original PPS case-mix weights.
Comment: A commenter stated that
no explanation was provided on
segmented choice of periods of
evaluation. This commenter wrote that
it is unclear why Abt subdivided the
2000–08 period into 2000–2007 and
2007–2008. To minimize the possibility
for shifts in the relationship between
resource requirements and explanatory
variables, Abt could have subdivided
the 8-year period in half or at least
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performed some sensitivity analysis to
choose the time periods.
Response: The procedure of
identifying nominal case-mix change
relies on subtracting an average of
predicted weights from the average of
actual, billed weights. The case-mix
group system changed from one of 80
groups to 153 groups in 2008, causing
a change in the set of weights that could
be billed to Medicare. Up until 2008,
this was not an issue as the same set of
weights was used throughout the entire
history of the PPS up until that year. To
be able to bridge the periods before and
after the 153-group model, we rebased
the prediction model to the 2008 data,
the first year that the 153-group model
was used for paying HH providers. We
combined the results from the original
IPS-period equation with the results
from the rebased 2008 equation for this
year’s analyses. Our application this
year of the IPS-period equation was
unchanged (except for certain technical
changes in the APR–DRG grouper) from
our application of it for last year’s rule.
Comment: A commenter stated
hospital discharge data demonstrate that
HH patients are admitted from hospital
stays with a higher degree of acuity than
in the past. ‘‘The acute care (inpatient
prospective payment system (IPPS))
CMI for cases discharged to HHAs
reflects the patient severity of the
patients discharged to home health
agencies. As one of the measures for
patient severity is prior hospitalization,
it is believed to be unaffected by the HH
CMI. The CMI for the prior
hospitalization can be assumed to be a
proxy measure of the ‘‘real’’ case-mix
index. Based on our analyses of the
2007 and 2008 MedPAR data (Medicare
discharges from short term acute care
hospitals), we found that the CMI (MS
DRG-based CMI) of cases discharged to
HHAs increased by 2.5 percent from
1.588 in 2007 to 1.63 in 2008.
Furthermore, we also found that among
the acute care cases discharged to
HHAs, the proportion of cases
categorized as Medicare Severity
Adjusted Diagnosis Related Groups (MS
DRGs) with complications and
comorbidities increased by 3 percentage
points from 25 percent in 2007 to 28
percent in 2008. This implies that the
real case-mix index due to
comorbidities most likely increased for
the cases discharged to home health
agencies.’’
Response: The MedPAR data analyzed
in this comment cover the period when
the MS–DRG system was implemented.
We analyzed MS–DRG coding and
found evidence of changes in coding
and documentation practices that led to
increases in billed acute care case-mix
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weights. CMS actuaries estimated that a
2.5 percent increase in case-mix in the
hospital IP PPS was due to coding and
documentation changes occurring in FY
2008 (75 FR 50355). The results cited by
the commenter may have reflected the
weight-increasing hospital coding
behaviors addressed by the CMS
regulatory analysis. Therefore, we have
reason to believe that this measure alone
is not good evidence for assessing real
case-mix change. We must also point
out that our analyses employing the
APR–DRG system indicated that the
proportion of episodes with a Mortality
Risk Level 3 (Major) diagnosis increased
over time while the proportion with
Mortality Risk Level 2 (Moderate)
decreased. However, our regression
coefficients (for both the IPS and 2008
model) showed a negative relationship
between being in the moderate or major
risk of severity groups and case-mix.
Thus, the increase in the proportion of
patients in the highest mortality risk
category led to an estimate of lower
predicted case-mix. Given these types of
findings, it is not clear the extent to
which the CMI changes that the
commenter notes, even if they
represented an accurate measure, would
lead to a prediction of higher case-mix.
Comment: Several commenters
suggested we conduct an impact
analysis of the proposed rule relative to
case-mix, include an evaluation of
access in each year of any adjustment,
and consider all factors related to
access. These commenters felt that the
impacts in the proposed rule were
factually and legally inadequate, and
therefore, violated the Regulatory
Flexibility Act (RFA). A commenter
stated we should include an evaluation
of the effect of the proposed rule on
Medicare spending ‘‘in a whole sense,’’
not just the effect on HH services
spending.
Response: We have provided a
complete and comprehensive analysis
for the upcoming calendar year. As in
past years, we will address options for
regulatory relief for the succeeding
calendar year in the year before the rate
update becomes effective. There is no
language in the RFA that requires an
analysis of ‘‘out-year’’ expenditures. The
state of the art is not adequate for
forecasting effects on all Medicare
spending.
Comment: Commenters suggested that
CMS remove the case-mix adjustment
for medical supplies unless CMS can
develop a method to accurately
determine what percentage of the casemix change is ‘‘real’’ and what
percentage is ‘‘nominal.’’
Response: We believe that coding
practice changes have affected the case-
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mix assignment for the nonroutine
medical supplies (NRS) payment level.
The OASIS items used in making the
case-mix assignment are potentially
vulnerable to the same types of forces
that affect coding for the episode casemix group, that is, improvements in
coding and more complete coding, more
specific definitions, increased reporting
of secondary diagnoses, and other
causes of coding practice change.
However, since the nominal case-mix
change measure was designed to apply
to the episode case-mix system, the
nominal case-mix change measure may
not directly apply to the NRS case-mix
model. Therefore, we will defer the
application of the payment reduction to
the NRS conversion factor for CY 2011
until a review of the nominal case-mix
change measure can be performed.
Comment: Commenters stated that it
appears that the CMS case-mix weight
change analysis never specifically
evaluated any evidentiary basis for its
determination that the hypertension
diagnostic coding was a nominal change
in case-mix. Instead, we assume that the
increased coding of hypertension is
upcoding.
Response: We proposed to delete
ICD–9–CM code 401.9, Unspecified
Essential Hypertension, and ICD–9–CM
code 401.1, Benign Essential
Hypertension, from the HH PPS casemix model’s hypertension group, in
order to correlate with the goals of our
HH PPS case-mix system.
We continue to be concerned that the
increase in reporting of unspecified
hypertension and benign hypertension
signals that continued inclusion of these
codes in our case-mix system threatens
to move the HH PPS case-mix model
away from a foundation of reliable and
meaningful diagnosis codes. As we
described in our proposed rule, the data
indicate a jump of approximately 12
percentage points in the reporting of
unspecified hypertension when the
refined HH PPS added hypertension as
a case-mix code in 2008. The proposed
rule also described that the data
suggested no HH added resource
requirements are associated with
hypertension, unspecified, which is by
far the most commonly reported
hypertension code.
In our proposed rule, we also
described that the 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
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provided specific clinical guidelines for
prevention, detection, and treatment of
high blood pressure. 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. 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. We described
our concerns surrounding the new
guidelines for hypertension which we
suspected might have led to an
increased prevalence of codes 401.1 and
401.9 in 2008 HH claims, along with
some evidence that HH patients with
either unspecified or benign
hypertension no longer require extra
resources. We described that these
results appear possibly consistent with
a phenomenon in which agencies
increased their reporting of
hypertension in situations that did not
meet the HH diagnosis reporting
criteria; the results are suggestive of
changed coding practice in which lesssevere episodes are being reported with
hypertension in 2008 than used to be
the case. As such, we described that we
believe including codes 401.1 and 409.9
in the HH PPS case-mix model reduces
the model’s accuracy, and that we do
not believe we should be including
these diagnoses in our case-mix system.
We received many comments opposed
to the removal of these codes.
Comment: Commenters stated that
currently CMS is penalizing HHAs
twice for the nominal case-mix changes
due to hypertension coding by
proposing to remove the hypertension
codes and by including the case-mix
changes due to hypertension coding in
the calculations for payment reductions.
Response: We disagree with the
commenters who believe that, by
removing these codes while also
reducing HH base episode payment
rates due to coding change, we are in
effect double-counting for growth in
case-mix unrelated to real changes in
patient health status twice. We
proposed to remove these codes from
the case-mix system beginning in CY
2011. Our updated analysis, which
measures changes in case-mix, both
nominal and real, used data from the
inception of HH PPS through 2008. As
such, by removing these hypertension
codes we would expect a slower growth
of hypertension-related nominal casemix beginning in CY 2011. However, as
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explained in response to a different
comment (below), we are not finalizing
our proposal to remove hypertension
codes 401.1 and 401.9. We assure
commenters that if we were to remove
these codes from our case-mix system
we would do so in such as way that we
would recalibrate our case-mix weights
to ensure that the removal of the codes
would result in the same projected
aggregate expenditures.
Comment: A commenter stated that
the 2008 HH PPS methodology is based
upon a determination that a
hypertension diagnosis indicates a
higher degree of resource need and
utilization by patients with that
diagnosis. Nothing in the CMS analysis
indicates that anything other than this
original finding is supportable. As such,
concluding that an increase in patients
with a hypertension diagnosis is
anything other than a change in patient
characteristics is illogical and in error.
Response: If the underlying
proportion of patients with
hypertension has not changed, then the
increase in the observed prevalence of
hypertension is an indication of a
change in coding practices, even if it
reflects more accurate coding. As such,
the increased prevalence is not real
case-mix change, as it does not
represent cost increases related to the
health status of patients.
Comment: Commenters stated that
CMS opines that the 2003 changes in
diagnostic coding guidance led to the
increase in incidence of hypertension
coding rather than changes in patient
characteristics. However, the 2003
changes were fully operational at the
time in 2007 when CMS proposed and
finalized the 2008 HH PPS version that
includes hypertension as a factor in the
patient classification system.
Response: We believe that the 2003
NHLBI guidance (‘‘Seventh Report of the
Joint National Committee on Prevention,
Detection, Evaluation, and Treatment of
High Blood Pressure’’, Journal of the
American Medical Association, May 21,
2003) may have led to changes in coding
hypertension, but that diffusion of the
new information probably occurred over
several years. The case-mix model of the
Final Rule referenced by the commenter
was based on 2005 data.
Comment: One commenter stated that
diagnosis codes 401.1 and 401.9 should
be retained in the case-mix system,
because very often clinically complex
patients such as hypertensive heart
disease patients will be diagnosed with
the code 401.9 while waiting for proper
documentation that is required by ICD–
9–CM in order to report a more specific
diagnosis code. Another commenter
urged CMS to perform additional
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analysis to assess the severity of
individuals with hypertension codes
401.1 and 401.9 in order to determine
whether these codes should be
eliminated. The commenter suggested
that CMS look at the resource use and
the change in the number of visits for
patients with codes 401.1 and 401.9
from 2005 to 2008 and compare them to
data on individuals with other
hypertensive diagnosis codes, while
controlling for differences in patient
characteristics.
Response: We find these comments
compelling. HHAs are expected to
adhere to ICD–9–CM coding guidance.
The commenter states that ICD–9–CM
coding guidance requires specific
documentation be obtained prior to
coding certain complex hypertensive
diseases such as hypertensive heart
disease, and such documentation may
take time to obtain. The commenter
states that agencies may have no choice
other than to code such patients using
code 401.9 pending receipt of such
documentation. Therefore, for such
patients, deletion of these codes may
delay access to needed home care. We
agree with the commenter who urged
CMS to expand our resource use
analysis for hypertension codes 401.1
and 401.9 to control for patient
characteristic differences, and also
compare the resource usage of patients
with these codes to the resource usage
of patients with other hypertension
diagnosis codes. We agree that this
suggested comprehensive analysis will
enable us to identify whether there are
sub-categories of patients currently
assigned codes 401.9 or 401.1 who are
more resource intensive, such as the
hypertensive heart disease patient,
enabling us to revise our case-mix
system to account only for those
resource intensive patients. As such, we
are deferring removal of the
hypertension codes from our case-mix
model pending completion of the
suggested analysis.
In the interim, we are committed to
slowing the growth of nominal case-mix
by addressing the inappropriate
reporting of these codes. We plan to
target providers for review who have
substantive growth in the reporting of
these codes, or higher than expected
instances of reporting them. We also
reiterate the need for providers to follow
the OASIS Attachment D coding
guidance, found at https://www.cms.gov/
HomeHealthQualityInits/
14_HHQIOASISUserManual.asp, where
we explain that providers must only
code a diagnosis if it is addressed in the
HH plan of care and affects the patient’s
responsiveness to treatment and
rehabilitative prognosis.
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Finally, we would like to clarify that
page 12 of the 2003 statement by the
National Heart, Lung and Blood
Institute (NHLBI) ‘‘Seventh Report of the
Joint National Committee on Prevention,
Detection, Evaluation, and Treatment of
High Blood Pressure’’ (the JNC 7 report),
published in the May 21, 2003, Journal
of the American Medical Association
explicitly states that prehypertension is
not a disease category, which indicates
that the coding of 401.1 or 401.9 for prehypertensive patients would not be
appropriate. This is consistent with preexisting ICD–9–CM guidance, which
describes essential hypertension as SBP
of 140 and above.
Comment: A commenter stated that
the proposed 3.79 percent adjustment
for nominal case-mix change appears to
be based primarily on the inclusion of
hypertension as a patient diagnosis and
modified provision of therapy services
consistent with the HH PPS model
revision in 2008.
Response: As previously stated, the
proposed adjustments for CY 2011 and
CY 2012 took into account all of the
nominal case-mix growth we measured
between the IPS baseline and CY 2008,
and netted out nominal case-mix growth
that was already accounted for in
previous rate reductions. As of last
year’s rate update regulation, we
anticipated a need to compensate for a
total nominal growth of 13.56 percent.
This year’s analysis showed that
reductions previously planned to be
implemented were not adequate to
compensate for the full total of nominal
growth (17.45 percent) that has occurred
through 2008. Our method for deriving
the real and nominal case-mix change
percentages did not isolate any specific
sources of nominal growth (such as
hypertension coding) upon which to
base the reduction. However, the
proposed rule for CY 2011 described
statistics showing a large 1-year increase
in hypertension reporting between 2007
and 2008, and it noted that the observed
growth in the numbers of episodes with
high numbers of therapy visits was
unexpected. The proposed rule also
discussed evidence beyond
hypertension and therapy, such as
increased reporting of secondary
diagnoses in general.
In summary, in this final rule, we are
implementing the proposed 3.79 percent
reduction to the national standardized
episode rate for CY 2011. We will defer
finalizing a payment reduction for CY
2012 until further study of the case-mix
change data and/or methodology is
completed. In addition, in this rule, we
are withdrawing the proposal to apply
the case-mix change reduction to the
NRS conversion factor. As part of our
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review of the nominal case-mix change
methodology, we will study its
applicability to the NRS model. The
NRS conversion factor will be updated
in CY 2011 by the market basket update
of 1.1 percent and will also be adjusted
for outlier payments in accordance with
section 3131(b) of the Affordable Care
Act. We are also withdrawing our
proposal to eliminate ICD9–CM
diagnosis codes 401.1, Benign Essential
Hypertension, and 401.9, Unspecified
Essential Hypertension, from the HH
PPS case-mix model’s hypertension
group, pending the results of a more
comprehensive analysis of the resource
use of patients with these conditions.
B. Therapy Clarifications
In the CY 2011 HH PPS proposed
rule, we discussed analyses that
suggested that therapy under the
Medicare HH benefit, in many cases,
was being over-utilized. Analysis of HH
utilization under the original single
10-visit therapy threshold suggests that
the threshold offered a strong financial
incentive to provide therapy visits when
a lower amount of therapy was more
clinically appropriate. Essentially, the
data suggested that financial incentives
to provide 10 therapy visits
overpowered clinical considerations in
therapy prescriptions. For the CY 2008
final rule, we established a system of
three thresholds (6, 14, and 20 therapy
visits) with graduated steps in between
to meet our objectives of retaining the
prospective nature of the payment
system, reducing the strong incentive
resulting from the single 10 therapy
threshold, restoring clinical
considerations in therapy provision, and
paying more accurately for therapy
utilization below the 10-visit therapy
threshold.
In the proposed rule, we described
that analysis of CY 2008 data continues
to suggest that some HHAs may be
providing unnecessary therapy.
MedPAC states in its March 2010 report
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). While this analysis suggested that
therapy payment policies are vulnerable
to fraud and abuse, the swift, across-theboard therapy utilization changes also
suggest another more fundamental
concern. MedPAC wrote in the March
2010 report (MedPAC, 2010, p. 206) that
payment incentives continue to
influence treatment patterns, and that
payment policy is such a significant
factor in treatment patterns because the
criteria for receipt of the HH benefit are
ill-defined. MedPAC also reported that
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better guidelines would facilitate more
appropriate use of the benefit.
As such, in the CY 2011 HH PPS
proposed rule, we proposed 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. Specifically, we proposed the
following:
• Require that measurable treatment
goals be described in the plan of care
and that the patient’s clinical record
would demonstrate that the method
used to assess a patient’s function
would include objective measurement
and successive comparison of
measurements, thus enabling objective
measurement of progress toward goals
and/or therapy effectiveness.
• Require that a qualified therapist
(instead of an assistant) perform the
needed therapy service, assess the
patient, measure progress, and
document progress toward goals at least
once least every 30 days during a
therapy patient’s course of treatment.
For those patients needing 13 or 19
therapy visits, we proposed to require
that a qualified therapist (instead of an
assistant) perform the therapy service
required at the 13th or 19th visit, assess
the patient, and measure and document
effectiveness of the therapy. We would
cease coverage of therapy services if
progress towards plan of care goals
cannot be measured, unless the
documentation supports the expectation
that progress can be expected in a
reasonable and predictable timeframe.
An exception to this would be when the
criteria for needing maintenance
therapy are met.
• Clarify when the establishment and
performance of a maintenance program
is covered therapy.
Comment: A number of commenters
were in strong support of our efforts to
rein in abuse and overuse of therapy
through sound documentation, objective
measurement, and appropriate
involvement of qualified therapists.
Commenters expressed support for
proposed additional requirements of
documentation of the patient’s clinical
record, including therapy treatment
goals to be described in the plan of care
and objective measurement obtained
during the functional assessment. One
commenter stated that the elements of
documentation added in our proposed
regulations are reflective of professional
standards for the practice of speechlanguage pathology. Another commenter
expressed general support of our
therapy coverage and documentation
requirements, including those for
patient assessment, physician
collaboration, plan of care, goal
establishment, evaluation of progress
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toward goals through objective
measures, and documentation,
indicating they are all reflective of
professional standards of practice for
therapy services, such as those
established by named major therapy
associations. Another commenter
expressed support for the proposed
therapy coverage requirements
regarding functional assessments,
treatment plan revisions, and accurate
documentation, indicating that these
requirements align with professional
standards of clinical practice.
Response: We thank the commenters
for their support.
Comment: Numerous commenters
expressed concern regarding the
provision of the proposed rule requiring
that a qualified therapist, instead of an
assistant, perform the needed therapy
service at the 13th and 19th therapy
visits. These commenters stated that
therapy visits by a qualified therapist
beyond those already conducted on the
1st, 30th, and 60th days would be
prohibitively expensive to HHAs and an
unnecessary intrusion for patients. A
number of commenters suggested that
requiring a qualified therapist, instead
of an assistant, to perform the needed
therapy service every 30 days should be
sufficient, stating that requiring a
qualified therapist to perform the
therapy service on the 13th and 19th
visits was excessive. A commenter
suggested that because only 15 percent
of episodes contained more than 13
therapy visits and only 5 percent of
episodes contained more than 19
therapy visits, CMS should consider the
increased costs of its proposed required
therapy changes versus the actual need
for the new requirement. Commenters
quoted recent findings of a health care
consulting company’s survey of HH
providers regarding the proposed
therapy clarifications, stating that most
providers believe the proposed therapy
changes would lead to scheduling
difficulties for therapy visits and would
cause difficulties in employing/
contracting qualified therapists. A few
commenters asked CMS to delay the
implementation date of this provision
by one quarter to allow more transition
time for providers. Several commenters
suggested, as an alternative to the
requirement that a qualified therapist
perform the needed therapy service at
the 13th and 19th visit, that adopting
ranges would be more acceptable—for
example, allowing the qualified
therapist visit to occur between the 11th
and 13th visits and again between the
17th and 19th visits. Another
commenter proposed that CMS should
instead defer to State law requirements,
asserting that most States require more
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frequent qualified therapist supervision
of assistants than those in the proposed
rule, and the proposal’s timeframes
would be redundant to State laws. The
commenter further stated that the
proposed defined timeframes are in
conflict with § 409.44(a) as they fail to
reflect attention to the patient’s
individual needs. Further, the
commenter suggested that CMS abandon
the 13th and 19th qualified therapist
visit requirement and instead base the
reassessment timeframe on individual
care needs and changes in patient
status. That same commenter added that
assistants utilize their clinical reasoning
skills every time they treat a patient and
advise the supervising therapist
regarding the patient’s need for
continued skill intervention and grading
of treatment and, therefore, the
requirement for qualified therapist visits
at defined timeframes is not reasonable.
A commenter classified all our proposed
therapy visit rules as arbitrary at best, as
well as calling these latest rules
regarding the 13th and 19th assessments
capricious. One commenter stated that a
requirement to re-evaluate patients at
the 13th and 19th visits may not be
effective in curbing agencies from
inappropriately using the benefit in the
long-run, suggesting that some agencies
will soon learn how to work the revised
system to their benefit. A commenter
stated that, while overall therapy
utilization has increased, it has led to
better outcomes for Medicare
beneficiaries and overall spending per
Medicare patient has remained well
below Congressional Budget Office
(CBO) projections. Referring to the
aforementioned survey results, the
commenter described the surveyed
HHAs’ concern that the proposed
clarifications would result in limited
improvements in patient care. Several
commenters believed that the proposed
changes would have an adverse effect
on access to care and timeliness of
services provided and that these
requirements would result in less direct
patient care time. Many commenters
stated that the documentation
requirements were burdensome and
costly. Several commenters feared that
these requirements would impede
access to care in rural areas where there
are shortages of qualified therapists.
Response: We thank the commenters
for their suggestions. We continue to
believe that to ensure Medicare HH
patients receive effective, high-quality
therapy services, the frequency that a
qualified therapist must assess the
effectiveness of services performed by
assistants must be more clearly defined
in Medicare home health coverage
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regulations. Longstanding Medicare
Conditions of Participation (CoPs)
regulations at § 484.32(a) require that
HH therapy services be administered by
a qualified therapist or a qualified
assistant under the therapist’s
supervision, thus requiring a qualified
therapist to supervise therapy services
to ensure their effectiveness. We believe
that in order to adhere to these
regulations, a qualified therapist must
periodically perform the patient’s
needed therapy service during the
course of treatment to ensure that the
therapy being provided by assistants is
effective and/or that the patient is
progressing toward treatment goals.
These visits ensure that the qualified
therapist has first-hand knowledge of
the patient in order to identify needed
changes to the care plan. Additionally,
these visits enable a qualified therapist
to determine if treatment goals have
been achieved or if therapy has ceased
to be effective. We note that some States
preclude assistants by scope of practice
from making determinations such as
whether goals are met. As such, we
believe that by requiring a qualified
therapist, instead of an assistant, to
perform the needed therapy service,
assess the patient, and measure and
document progress toward goals and/or
effectiveness of therapy at defined
points in the course of treatment, we
would lessen the risk that patients
continue to receive therapy after the
treatment goals have been reached and/
or after therapy is no longer effective.
In response to the commenter who
stated that while overall therapy
utilization has increased, such increased
utilization has led to better outcomes for
Medicare beneficiaries, we disagree
with the conclusion. In their March
2010 report, MedPAC described that
functional measure scores for HH
patients continue to improve, but also
expressed concerns that the measures
may not appropriately depict the quality
of therapy provided by HHAs. MedPAC
reports that there are no measures,
which reflect functional improvement
for only those patients that receive
therapy services. Instead, the measures
reflect functional improvement for all
patients. Therefore, we believe that the
data do not support the commenter’s
conclusion that higher volumes of
therapy have led to better outcomes.
The same commenter, pointing to
results of the survey described above,
stated that the HHAs believe these
proposed therapy coverage clarifications
would result in limited improvements
in patient care. Again, we disagree with
these opinions. We refer the commenter
to research studies conducted by Linda
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Resnick (of Brown University) et al.,
entitled ‘‘Predictors of Physical Therapy
Clinic Performance in the Treatment of
Patients with Low Back Pain
Syndromes’’ (2008, funded by a grant
from the National Institute of Child
Health) and ‘‘State Regulation and the
Delivery of Physical Therapy Services’’
(2006, funded in part through a grant
from the Agency for Healthcare
Research and Quality). Both studies
concluded that more therapy time spent
with a qualified physical therapist, and
less time with a physical therapist
assistant, is more efficient and leads to
better patient outcomes. In these
studies, the lower percentage of time
seen by a qualified therapist and the
greater percentage of time seen by an
assistant or aide, the more likely a
patient would have more visits per
treatment per episode. The studies also
concluded that, although delegation of
care to therapy support personnel such
as assistants may extend the
productivity of the qualified physical
therapist, it appears to result in less
efficient and effective services. We
believe that by requiring regular visits
by a qualified therapist during a course
of treatment we will achieve more
appropriate and efficient provision of
therapy services while also achieving
better therapy outcomes. Regarding the
comment that HH expenditures are
below CBO projections, we are unclear
on the commenter’s suggestion. We
believe that the commenter may have
been suggesting that the growth in HH
expenditures does not warrant our
attempts to facilitate more appropriate
and effective therapy utilization. If so,
we disagree with the commenter. We
continue to believe that these improved
guidelines, as suggested by MedPAC,
are an important step in addressing
program vulnerabilities while also
improving the quality of services
provided. We also disagree with the
commenters who believe that a qualified
therapist visit every 30 days is
sufficient, and that the required 13th
and 19th visits are excessive and
redundant to many state practice
supervision requirements, and that the
13th and 19th visit requirement
timeframes fail to reflect the patient’s
individual needs. As we have noted in
this and previous rules, at the inception
of the HH PPS we analyzed the amount
of therapy a HH rehabilitation patient
would typically require during a course
of treatment. We used clinical judgment
to determine that the typical
rehabilitation patient in a HH setting
would require about 8 hours of therapy,
or 10 therapy visits during a course of
treatment. We believe that when the
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unique condition of an individual
patient requires more therapy than a
typical Medicare HH rehabilitation
patient, such a patient should be more
closely monitored by a qualified
therapist to ensure that high-quality,
effective services are being provided
and/or acceptable progress toward goals
is being achieved. We also continue to
believe that to ensure that this
monitoring occurs for all high-therapy
needs Medicare patients, we cannot
depend on individual state supervision
requirements. Instead, Medicare
coverage clarifications will ensure that
all Medicare HH patients benefit from
this oversight. We also disagree with
commenters that these policies will lead
to an intrusion for patients. To the
contrary, research suggests that more
qualified therapist involvement would
further enhance patient care for those
patients needing these levels of therapy.
We also note that these policies will not
result in additional visits or therapy
services provided to the patient. The
visit by a qualified therapist would not
be in addition to the visit that would
otherwise occur, as described in the
patient’s treatment plan. Instead, the
qualified therapist, perhaps instead of
an assistant, would perform the therapy
service at defined points in the course
of treatment. In response to the
commenter who questioned whether a
comprehensive assessment of the
patient would need to occur during
these qualified therapist visits, we refer
the commenter to the regulation text
changes at § 409.44(c)(1)(iv) which
describes that the qualified therapist
must assess a patient’s function using
objective measurement of function. In
other words, the assessment of function
would not be a comprehensive
assessment of the patient’s clinical
condition.
In response to the commenters who
expressed cost and access to care
concerns associated with these policies
we note that current CoPs at § 484.12
already require that the HHA and its
staff comply with accepted professional
standards and principles that apply to
professionals furnishing services by a
HHA. Those accepted professional
standards include complete and
effective documentation, such as that
which we described in our proposal.
(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.’’) In addition, § 484.2 requires
that a clinical note be a notation of
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contact with a patient that is written
and dated by a member of the health
team, and that describes signs and
symptoms, treatment and drugs
administered and the patient’s reaction,
and any changes in physical or
emotional condition, which becomes
part of the medical record. Further,
§ 484.48, our longstanding regulation for
CoPs and clinical records, requires that
a clinical record containing pertinent
past and current findings in accordance
with accepted professional standards be
maintained for every patient receiving
HH services. In addition to the plan of
care, the record must include treatment
plans and activity orders, signed, and
dated clinical and progress notes, and
copies of summary reports sent to the
attending physician. Because these
proposed clarifications to our therapy
coverage requirements are consistent
with long-standing CoP requirements
and accepted professional standards of
clinical practice, we would expect that
many providers have already adopted
these practices.
Also, because CoPs at § 484.32 allow
therapy services offered by the HHA to
be provided by a qualified therapist or
a qualified assistant under the
supervision of qualified therapist and in
accordance with the plan of care, it is
our expectation that HHAs are already
utilizing qualified therapists regularly to
perform the needed therapy services in
order to perform the required
supervision of assistants.
We agree with the commenter that
most HH therapy patients do not receive
13 and/or 19 visits in their course of
treatment. In response to the comments
which stated the relatively small
numbers do not warrant the 13 and 19
qualified therapist visit and
documentation requirements, suggesting
instead that we target providers with
suspect therapy practices for review, we
reiterate that we believe these
requirements benefit all patients. We
believe that these requirements may also
deter inappropriate provision of high
levels of therapy, and therefore lessen
the risk of the associated inappropriate
higher HH PPS payments. In summary,
by requiring qualified therapist visits
when the amount of therapy reaches
those high levels, which also
correspond to high payment levels, we
believe we can simultaneously achieve
better patient outcomes, more efficient
provision of therapy, and more accurate
reimbursement.
We find compelling the commenters’
concerns regarding scheduling
difficulties. We believe the commenters’
concerns regarding scheduling warrant
more flexibility in the timing of the 13th
and 19th visit requirements. Therefore,
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we have decided to allow for some
flexibility associated with the 13th and
19th therapy visit rule for patients.
Specifically, for beneficiaries in rural
areas, the qualified therapist may
perform the needed therapy service,
reassessment and measurement at any
time after the 10th therapy visit but no
later than the 13th therapy visit, and
after the 16th therapy visit but no later
than the 19th therapy visit. And, if
extenuating circumstances outside the
control of the therapist preclude the
therapy service visit, reassessment and
measurement at the 13th and 19th
timeframes, the qualified therapist may
perform the therapy service visit,
reassessment and measurement at any
time after the 10th therapy visit but no
later than the 13th therapy visit, and
after the 16th therapy visit but no later
than the 19th therapy visit.
Regarding the access to care concerns,
we believe that these requirements will
ultimately result in more access to
effective therapy services. MedPAC
reports broad access to HH care for
Medicare beneficiaries. As such, we do
not expect that these coverage
clarifications will result in access to
care issues, but we will monitor for
unanticipated effects.
We note, however, because of the
volume of comments we received on
this issue, we believe that many
agencies have not been in compliance
with the documentation practices and
qualified therapist oversight we would
expect. Therefore, we have decided to
delay the effective date of these
requirements until April 1, 2011, to
allow agencies that do not currently
have such practices in place additional
time to transition.
Comment: A number of commenters
expressed support for our efforts to
require reassessments, but had
questions as to how assessment visit
requirements at the 13th and 19th visit
would work when multiple therapy
disciplines are providing care.
Specifically, commenters stated that
because HH therapy can consist of any
combination of three therapy
disciplines, it would be difficult for
therapists to track the 13th and 19th
visits if more than one therapy
discipline was serving the patient.
Commenters asked how it would be
determined which therapist would do
the 13th and 19th assessments.
Additionally, commenters were
concerned that CMS might be expecting
a therapist of one discipline to do the
assessment for the therapist of another
discipline. Commenters stated that it
would be unrealistic and cumbersome
to track the 13th and 19th visits,
especially when there are multiple
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therapy disciplines involved. In a
related comment, a commenter
recommended further clarification of
the proposed regulations by requesting
that CMS further specify that
professional standards should be those
pertaining to the individual professions.
The commenter also stated that, because
existing Medicare regulations require
compliance with Federal, State, and
local laws, requiring the proposed
qualified therapist visits at defined
points in the course of treatment could
contradict State licensure and scope of
practice laws.
Response: We concur with the
commenters that we need to clarify our
expectation when more than one
therapy discipline is providing services
to the patient. We will clarify the
regulation text to state that the policy
applies to each discipline separately.
The patient’s function must be initially
assessed and periodically reassessed by
a qualified therapist of the
corresponding discipline for the type of
therapy being provided (that is, PT, OT,
and/or SLP). When more than one
therapy discipline is being provided, the
corresponding qualified therapist would
perform the reassessment during the
regularly scheduled visit associated
with that discipline which was
scheduled to occur as near as possible
to the 13th and 19th visit, but no later
than the 13th and 19th visit.
We also note that a small percentage
of patients which receive 13 and 19
therapy visits receive more than 1
therapy discipline. In addition, HHAs
must coordinate their patients’ care per
longstanding conditions of participation
at § 484.14(g). As such, we would expect
such coordination to already be
occurring. Given the low volume of
such patients and the added flexibility
as described above, we do not believe
that the coordination associated with
multi-therapy discipline patients will be
overly burdensome. However, we will
monitor the effects of this provision to
identify unintended consequences.
Comment: Several commenters
suggested that instead of putting
additional requirements on all HHAs in
response to a smaller number of HHAs
who are abusing the system, CMS
should target those agencies that are
providing unnecessary therapy. A few
commenters urged CMS to consider how
the therapy provisions of this rule
would affect HHAs, especially in rural
areas, where there is a shortage of
therapists. A commenter also stated that
the notion that HH expenditures were
high due to unnecessary therapy visits
is inaccurate and provided statistics that
he believes prove therapy
overutilization is not a problem.
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Response: As we have described in
previous comment responses, we
believe that these proposed
requirements will strengthen the
integrity of the benefit while also
resulting in better patient outcomes. We
believe all HHAs, not just suspect
agencies, should adhere to these best
practices in order to provide highquality and effective therapy services,
consistent with existing CoPs.
Comment: A few commenters
expressed concern regarding therapy
services possibly not being covered after
a hospitalization, as a result of these
assessment visit requirements.
Specifically, the commenters were
concerned that we were imposing new
limits on maintenance therapy.
Commenters expressed fear that the
result of not covering such therapy
services might be that many high fall
risk patients would be sent home
without therapy care, which would lead
to increased falls/hospitalizations/
fractures that would increase Medicare
spending in the end. Another
commenter stated that physical therapy
and occupational therapy were utilized
more for safety evaluations and fall
prevention measures, especially for
patients on medication, which places
them at a higher risk for falls. This
commenter added that fall prevention
best practice interventions provided in
patients’ homes save Medicare money.
Similarly, a commenter asked CMS to
clarify therapy coverage for pain.
Response: We agree with the
commenter that fall prevention practices
and/or pain management are essential
for many HH patients in order to
provide the patient with quality care.
We remind the commenter that a
longstanding coverage requirement for
HH therapy services under Medicare is
that the services which the patient
needs must require the performance by
or supervision of a qualified therapist.
Whether or not fall prevention services
and pain management services are
covered therapy depends on the unique
clinical condition of the patient and the
complexity of the needed therapy
services. Many fall prevention services
would not require the skills of a
therapist. Longstanding regulations
allow therapy coverage when, for safety
and effectiveness reasons, the unique
medical complexities of the patient
require a qualified therapist’s skills in
the establishment or performance of a
therapy maintenance program. As such,
should the unique clinical condition of
a patient require that the specialized
skills, knowledge, and judgment of a
qualified therapist are needed to design
and establish a safe and effective
maintenance program in connection
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with a specific illness or injury, then
such services would be covered as
therapy services.
Comment: Commenters were opposed
to the requirement that a skilled nursing
service must be needed in order to have
maintenance therapy covered, and that
a maintenance program cannot be
established after restorative therapy has
ended.
Response: The intent of language in
the proposed rule was to clarify that, in
order for the establishment of a
maintenance therapy program to be
considered covered therapy, the
specialized skills, knowledge, and
judgment of a therapist would be
required in developing a maintenance
program. 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. In the
proposed rule, we further noted
scenarios in which maintenance therapy
may be provided in the home setting.
The language in the proposed rule
was not meant to indicate that
maintenance therapy could not be
provided as the sole skilled service and
would be covered only if ancillary to
another skilled qualifying service. The
proposed clarifications were not
intended to expand or limit existing
coverage criteria. We regret the
confusion these scenarios may have
caused. We note that therapy coverage
criteria have always been based on the
inherent complexity of the service
which the patient needs. As such,
maintenance therapy has and will
continue to be covered in the HH setting
when the unique clinical condition of
the patient requires the complex
services which can only be provided
effectively and safely by a qualified
therapist. We will revise the proposed
regulation text to address the
commenters’ confusion.
Comment: A number of commenters
expressed concern regarding proposed
regulation text changes that state
therapy visits would not be covered for
transient or easily reversible loss or
reduction in function. Some
commenters who opposed the proposed
regulation text changes stated that these
changes would disallow coverage of
maintenance therapy, citing
longstanding Medicare HH coverage
policies previously set out in the
‘‘Health Insurance For the Aged, Home
Health Agency Manual,’’ Pub. 11 (HIM–
11) that allowed for the coverage of such
maintenance therapy. One commenter
recommended striking the language,
‘‘transient and reversible loss.’’ A
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commenter also stated that these
proposed regulation changes are in
direct conflict with section 1814(a)(2)(C)
of the Act. Commenters questioned
what criteria define a transient and
reversible reduction in function, or
when a patient’s condition could be
expected to improve spontaneously.
One commenter stated that it is difficult
to determine when conditions are or are
not transient and reversible, noting that
some patients who present a very
serious condition on admission may
recover quickly, while others with
seemingly less-serious conditions can
end up being far more complex as
treatments progress. Another
commenter stated we must take into
account the patient’s unique condition.
Response: We disagree with the
commenter that the proposed regulation
text changes conflict with section
1814(a)(2)(C) of the Act. We believe that
the commenter is inferring that by not
allowing therapy coverage for an easily
reversible reduction in function, we
would be denying coverage to a patient
who needs therapy, an eligibility
criterion listed in section 1814(a)(2)(C)
of the Act. We disagree with such
interpretation. Consistent with statute,
longstanding regulation, and
longstanding manual guidance, therapy
coverage under the HH benefit is based
on a patient’s need for skilled services.
The therapy services must be of such a
level of complexity and sophistication
or the condition of the beneficiary must
be such that the services required can
safely and effectively be performed only
by a qualified therapist or a qualified
therapy assistant under the supervision
of a qualified therapist. Services which
do not require the performance or
supervision of a qualified therapist are
not reasonable and necessary services,
even if they are performed by a qualified
therapist.
When 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, the services do not require the
performance or supervision of a
qualified therapist, and those services
are not considered reasonable and
necessary covered therapy services. We
acknowledge that making a
determination that 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 requires
clinical judgment and a consideration of
the patient’s unique condition. We
believe that rehabilitation professionals,
by virtue of their education and
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experience, are typically able to
determine when a functional
impairment could reasonably be
expected to improve spontaneously as
the patient gradually resumes normal
activities. Likewise, we expect
rehabilitation professionals to be able to
recognize when their skills are
appropriate to promote recovery. A
prescriptive definition of these sorts of
conditions, such as a listing of specific
disease states that provide subtext for
these descriptions is impractical, as
each patient’s recovery from illness is
based on unique characteristics. In
response to the commenter who believes
that the therapy clarifications would
disallow coverage of maintenance
therapy, we assure the commenter that
these clarifications do not impose new
limits on the criteria for maintenance
therapy coverage. We again note that
therapy coverage criteria have always
been based on the inherent complexity
of the service which the patient needs.
As such, maintenance therapy has and
will continue to be covered in the HH
setting when the unique clinical
condition of the patient requires the
complex services, which can only be
provided effectively and safely by a
qualified therapist. In addition, we note
that these clarifications are consistent
with longstanding manual guidance.
Comment: A commenter urged CMS
to address therapy coverage for
conditions that may not directly impact
functional status, such as the role of
therapists in wound care.
Response: We reiterate that if the
services do not require the performance
or supervision of a qualified therapist,
those services are not considered to be
reasonable and necessary covered
therapy services. As such, if a therapist
(who is qualified to do so per her or his
State Practice Act) would perform
services such as wound-care, those
services would be covered therapy only
if they required the skills of the
qualified therapist or qualified assistant
under the supervision of a qualified
therapist. Should a qualified therapist
(who is qualified to do so per her or his
State Practice Act) perform wound care
that does not require the specialized
skills of a therapist and could be
routinely performed by agency nursing
staff, these services would not be
covered therapy services.
Comment: A commenter expressed
concern over the proposed therapy
coverage clarifications, stating that the
proposed regulatory text changes are
major changes to current policy and that
they are in conflict with Medicare
statute and current law. The commenter
stated that Medicare coverage will be
more difficult to obtain for beneficiaries
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with chronic and debilitating conditions
if the proposals are finalized. The
commenter urged CMS to withdraw the
maintenance therapy regulation text
changes, stating that maintenance
therapy is a covered benefit in home
health and that Medicare statute does
not require improvement for services to
qualify for coverage. The commenter
stated that the restoration potential of a
patient is not the deciding factor in
determining whether skilled services are
needed, further stating that even if full
recovery or medical improvement is not
possible, a patient may need skilled
services to prevent further deterioration
or preserve current capabilities. The
commenter stated that a prescribed
therapy service which requires the skills
of a therapist to help maintain function
or prevent slow deterioration is
medically necessary and should be
covered under the statute. The
commenter stated that current
regulations recognize this, but the
proposed changes minimize this point,
and the commenter urged CMS to not
restrict benefits in order to fight fraud.
The commenter expressed concern
with the proposal’s use of the words
‘‘improvement’’ and ‘‘progress,’’ fearing
an increased emphasis on these terms in
the rules for therapy coverage will limit
access to care for patients who require
maintenance therapy. Further, the
commenter alleged that the proposed
rule would require improvement for
therapy to be covered. The commenter
suggested the word ‘‘effective’’ is more
appropriate than ‘‘improvement’’ or
‘‘progress.’’
The commenter believed that the
proposed regulation text will require the
therapist to use complex and
sophisticated therapy techniques in
order for maintenance therapy to be
covered and will thus be a new coverage
limitation preventing needed access to
therapy, and that the proposed
regulation text which states that
maintenance therapy must be required
in connection with a specific disease
would also newly limit maintenance
therapy coverage. Further, the
commenter alleged that the revised
regulation text does not consider the
unique condition of the patient as it
must and as does the current regulation
text. The commenter stated that the
proposal newly categorizes maintenance
therapy as not rehabilitative, while the
current regulations include both
restorative and maintenance therapy as
rehabilitative. The commenter stated
that, should CMS require improvement
as a therapy coverage criterion, CMS
would be applying an arbitrary ‘‘rule of
thumb’’ which does not consider the
patient’s individual condition, and such
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a requirement for improvement conflicts
with the current regulation at § 409.42.
Further, the commenter stated that the
proposed regulation text changes will
result in denials of Medicare coverage
for beneficiaries with long-term,
progressive, or incurable conditions.
The commenter also took issue with the
proposed regulation text change to
require the documentation of progress
toward goals.
The commenter further stated that the
definition of maintenance therapy is too
vague and restrictive. The commenter
also took issue with the proposed
regulation text, which requires that, in
order for maintenance therapy to be
covered, the skills of a therapist must be
needed to ensure the patient’s safety
‘‘and’’ the skills of a therapist are needed
to provide a safe and effective
maintenance program. The commenter
believed that we should replace the
‘‘and’’ with an ‘‘or’’. The commenter also
stated that the regulation does not
define ‘‘reasonable and necessary’’ in a
way that clearly provides for coverage of
maintenance therapy. As was also
mentioned by other commenters, this
commenter was concerned that the
proposed regulation text describes
coverage of the development of a
maintenance program during the last
visit(s) for rehabilitative therapy, stating
that, often, standard practice is to
establish and instruct the patient in an
appropriate maintenance program at the
outset of a course of therapy. The
commenter also spoke to the proposed
regulation text change, which appears to
indicate that we would not cover the
establishment of a maintenance program
after a restorative therapy program has
ended, or if a beneficiary had never met
the criteria for restorative therapy. The
commenter stated that the proposed
regulation text would result in
maintenance therapy becoming a
dependent service.
Response: The proposed regulatory
text clarifications are intended to
neither limit nor expand the coverage of
therapy in the HH setting, but instead
are intended to provide clear therapy
guidelines, as suggested by MedPAC, to
deter inappropriate provisions of
therapy services. As we have described
in earlier responses to comments, we
also believe that these guidelines will
improve patient outcomes, improve
therapy effectiveness, and promote more
consistent compliance with the
Medicare CoPs. However, as we
described in an earlier comment
response, we agree with the commenter
that the proposed regulation text
changes may have been unclear in the
descriptive scenarios surrounding
coverage of the development of a
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maintenance program, and we will
revise the final regulation text changes
at § 409.44(c)(2)(iii)(B) to remove the
scenarios described in the proposed
rule’s § 409.44(c)(2)(iii)(B)(1) through
(B)(3).
We also agree with the commenter
that there are some additional changes
to the proposed regulation text that we
should finalize for better clarity. We
believe that these changes may alleviate
some of the commenter’s concerns that
the proposed rule limits coverage
associated with maintenance therapy,
and reassure the commenter that the
coverage criteria clarifications are
consistent with statute, current
regulations, and longstanding manual
guidance. Specifically, in response to
the commenter’s concern that we would
have newly categorized maintenance
therapy as non-rehabilitation, we will
delete the proposed regulation text at
§ 409.44(c)(2)(iii)(A)(2) and (A)(3) for
the final rule. We believe our attempts
to clarify these definitions are not
needed, as those definitions are well
defined in § 409.44(c)(2)(iii)(A) through
(iii)(C). We will also finalize some
technical changes to the proposed
regulation text, including replacing
several of the proposed regulatory text
references to improvements in function
with references to the effectiveness of
the care plan goals, as suggested by the
commenter.
We agree with the commenter that
that current regulations and
longstanding manual guidance are
consistent in that therapy services are
covered in the HH setting based on the
inherent complexity of the service
which the patient needs. As such,
maintenance therapy has and will
continue to be covered in the HH setting
when the unique clinical condition of
the patient requires the complex
services, which can only be provided
effectively and safely by a qualified
therapist.
Regarding the commenter’s concern
that the proposed rule stated that skilled
therapy is not reasonable and necessary
unless improvement is documented, we
disagree with the commenter’s
interpretation of the proposed rule.
However, we agree that we could have
been more clear in the regulation text
which describes the documentation
requirements at § 409.44(c)(2)(i). In the
final rule, we will clearly state that
maintenance therapy as defined in
§ 409.44(c)(2)(iii)(B) and
§ 409.44(c)(2)(iii)(C) would not be
subject to the criteria listed in
§ 409.44(c)(2)(i)(B)(4).
Concerning the comment that the
proposed regulation text, which requires
the therapist to use complex and
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sophisticated therapy techniques in
order for maintenance therapy to be
covered, imposes a new coverage
limitation associated with maintenance
therapy and will prevent needed access
to therapy, we refer the commenter to
longstanding manual guidance at 40.2.2
E. in chapter 7 of the Medicare Benefit
Policy Manual, CMS Pub. 100–2. This
section contains longstanding guidance
which uses the term ‘‘complex and
sophisticated procedures’’ when
describing reasonable and necessary
maintenance therapy. This same chapter
instructs a reviewer to consider the
inherent complexity of the service when
determining if the skills of a therapist
are required. The complexity and
sophistication of the service are
longstanding criteria used to assess
whether the skills of a therapist are
required. As such, we disagree with the
commenter that this is a new limiting
criterion. We also disagree that the
proposed regulation text changes do not
adequately consider the unique
condition of the patient when clarifying
coverage requirements. In fact, we
believe the proposed regulation text
changes at § 409.44(c)(2)(iii) refer more
comprehensively than the current
regulation text to the patient’s unique
clinical condition as a criterion for
determining whether the complex
services which must be provided by a
therapist are needed. Regarding the
commenter’s concern that the proposed
regulation text changes newly require
that maintenance therapy must be
needed in connection with a specific
disease, we also disagree. Current
regulations at § 409.44(c)(2)(iii) describe
that establishing a maintenance program
would be covered if the skills of a
therapist are needed to provide a safe
and effective maintenance program in
connection with a specific disease.
However, we agree that the words ‘‘in
connection with the patient’s illness or
injury’’ instead of ‘‘in connection with a
specific disease’’ would be an
improvement to the regulation text and
we are making this change in this final
rule. We disagree with the commenter
that current policy allows maintenance
therapy to be covered when the skills of
a therapist are needed to ensure the
patient’s safety OR the skills of a
therapist are needed in order to provide
a safe and effective maintenance
program. We have required in regulation
and longstanding manual guidance that
the skills of a therapist would be
required to ensure both patient safety
and effectiveness of a maintenance
program for the performance of
maintenance therapy to be covered.
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We refer the commenter to current
regulations at § 409.44(c)(2)(iii) and
longstanding manual guidance at 40.2.2
E. in chapter 7 of the Medicare Benefit
Policy Manual, CMS Pub. 100–2.
Regarding the commenter’s concern that
current § 409.32(c) mandates the
restoration potential of a patient is not
the deciding factor in determining
whether skilled services are needed, and
even if full recovery or medical
improvement is not possible, a patient
may need skilled services to prevent
further deterioration or preserve current
capabilities, we reply that we believe
the commenter may be
misunderstanding the current regulation
text at § 409.32(c) or interpreting this
out of its proper context. We believe it
is important to again note that the
emphasis for our therapy coverage
criteria is not on the issue of restoration
potential per se, but rather on the
beneficiary’s need for complex services
which require the skills of a qualified
therapist. Current regulations at
§ 409.32(c) specify that it is the
beneficiary’s need for skilled services
rather than his or her restoration
potential that is the deciding factor in
evaluating the need for skilled nursing
services in the HH setting. A
beneficiary’s restoration potential has
never been a factor at all in identifying
those services that constitute skilled
nursing care. Thus, nursing care can be
considered skilled without regard to
whether it serves to improve a
beneficiary’s condition or to maintain
the beneficiary’s current level of
functioning. In fact, as the original
version of this regulation’s text [as
initially codified at 20 CFR
§ 405.127(b)(2) (40 FR 43897, September
24, 1975)] makes clear, this provision’s
example of a terminal cancer patient
was intended to refer specifically to
nursing services that can be considered
skilled ‘‘even though no potential for
rehabilitation exists’’ (emphasis added).
Longstanding current regulatory
language at § 409.44(c) sets out the
criteria for skilled therapy (as opposed
to the skilled nursing criteria described
above) to be a covered service under
Medicare’s HH benefit. Current
regulations specify that HH therapy
services are covered based on the
inherent complexity of the service
which the patient needs, and whether
the needed services require the skills of
a qualified therapist. Further, current
regulations state that HH therapy
services are covered if there is an
expectation that the patient’s condition
will improve in a reasonable and
predictable timeframe based on the
physician’s assessment of the
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beneficiary’s restoration potential and
unique medical condition of the patient.
Current regulations also allow for
therapy coverage when, for safety and
effectiveness, the unique medical
complexities of the patient require a
qualified therapist’s skills in the
establishment or performance of a
therapy maintenance program.
Regarding the commenter’s concerns
that, should we require improvement as
a therapy coverage criteria, we would be
applying an arbitrary ‘‘rule of thumb’’
which does not consider the patient’s
individual condition, and as such, the
requirement conflicts with the current
regulation at § 409.44, we again assure
the commenter that we are not
expanding or limiting the coverage of
HH therapy. To address the
commenter’s concerns regarding the
potential for claims denials based on
‘‘rules of thumb,’’ we assure the
commenter that such denials are
prohibited.
‘‘Rules of thumb’’ in the Medicare
medical review process are prohibited.
Intermediaries must not make denial
decisions solely on the reviewer’s
general inferences about beneficiaries
with similar diagnoses or on general
data related to utilization. Any ‘‘rules of
thumb’’ that would declare a claim not
covered solely on the basis of elements,
such as, lack of restoration potential,
ability to walk a certain number of feet,
or degree of stability, is unacceptable
without individual review of all
pertinent facts to determine if coverage
may be justified. Medical denial
decisions must be based on a detailed
and thorough analysis of the
beneficiary’s total condition and
individual need for care.
Similar instructions have appeared as
far back as 1992 in the previous, paperbased manuals (available online at
https://www.cms.gov/Manuals/PBM/
list.asp), in section 3900.A of the
Medicare Intermediary Manual, Part 3
(CMS Pub. 13–3), and in section 214.7
of the Medicare SNF Manual (CMS Pub.
12).
Regarding the comment that the
proposed regulation does not define
‘‘reasonable and necessary’’ in a way that
clearly provides for coverage of
maintenance therapy, we believe the
commenter took issue with proposed
clarifications surrounding regulations at
§ 409.44(c)(2)(iv) which state that the
amount, frequency, and duration of
services must be reasonable. In these
revisions we describe that therapy can
be considered reasonable and necessary
when the criteria for maintenance
therapy are met. We believe the
commenter suggests we more
definitively state that therapy would be
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covered in such a case. We concur, and
we will make this change.
Comment: One commenter noted that
under a state’s approved Medicaid State
Plan Amendment, therapies may be
authorized as appropriate to maintain
function or to slow the rate of decline
in function. This commenter therefore
requested that we consider whether the
proposed rule language should be
revised to clarify a potential difference
in benefits [under Medicaid versus
Medicare] or if revised instructions
regarding Conditions of Participation
(CoPs) applicability is sufficient. For
whatever option we choose, this
commenter indicated that we should
contemplate using the Medicare rules as
the foundation for Medicaid HH
program rules as this commenter
believes that changes are needed to
accommodate the permitted differences
in benefits.
Response: We thank the commenter
but note such a suggestion is outside the
scope of this rule, and the issue for
which we solicited comments. We will
consider this suggestion in the future as
we analyze improvements to the HH
PPS.
Comment: Commenters stated that,
while they applaud our efforts to better
define medical necessity and document
therapy services, they were also
concerned that the new documentation
requirements will be a difficult
transition for HHAs, stating that the
proposed requirement would require
significant time and resources for HHAs
to ensure that their therapists and other
medical staff are educated and prepared
to implement the new requirements into
their everyday practices. Consequently,
this commenter recommended we
provide extensive educational outreach
and the commenter asked that we delay
implementation of these requirements to
provide agencies time to retrain staff.
This commenter also recommended
that we elaborate further on provisions
of the proposed § 409.44(c)(1), including
citing references to resources we used
for the phrase ‘‘with accepted standards
of clinical practice,’’ asking us to
indicate that these included resources
from professional associations. In
addition, this commenter asked that we
indicate that the ‘‘therapy goals’’ be
established by the qualified therapist in
conjunction with the physician. This
commenter also requested that we
further clarify what we mean by
objective measurement of therapy
progress by including activities of daily
living such as walking, eating, bathing,
etc. With respect to § 409.44(c)(2)(i), this
commenter asked that we clarify what
are considered to be ‘‘accepted practice’’
and ‘‘effective treatment.’’ Similar to
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other commenters, this commenter
requested that we further acknowledge
multi-therapy cases and insert language
that allows for some type of window for
completing the reassessment prior to or
after the 13th or 19th therapy visits,
stating that the adjustment should be
made to account for extenuating
circumstances that are outside the
control of the qualified therapist.
Regarding assistants making clinical
notes, this commenter suggested that we
change the phrase ‘‘job title’’ to
‘‘professional designation’’ and clarify
that written and electronic signatures
are acceptable. Some commenters asked
that we eliminate § 409.44(c)(2)(i)
altogether. Regarding § 409.44(c)(2)(iii),
this commenter requested that because
‘‘rehabilitative’’ and ‘‘restorative’’ are not
interchangeable, we change our
regulations to be consistent throughout,
using only the word ‘‘rehabilitative.’’
This commenter also asked that we add
a sentence to clearly state that the
maintenance program must be
established by the qualified therapist.
With respect to § 409.44(c)(2)(iv), this
commenter asked that we elaborate on
the phrase ‘‘with accepted standards of
clinical practice’’ and highlight the
importance of educating caregivers to
ensure patients receive the appropriate
level of care. The commenter also
requested that we delay implementation
of these requirements until April 2011
to allow time for providers to transition.
Response: We thank the commenter
for the suggested clarifications and we
have adopted the suggested
clarifications with some exceptions. We
have retained the language in our
current regulatory text at
§ 409.44(c)(2)(iii) which presently
mandates that for therapy to be covered,
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
medical condition. Typically, we use
the term ‘‘rehabilitative’’ to describe
services provided by therapists. In the
regulation text, we describe the
physician’s assessment and therefore we
believe the ‘‘restorative’’ terminology is
appropriate. However, we will finalize
additional changes to the proposed
regulation text to achieve more
consistency in the usage of these terms.
As described in an earlier comment, we
have adopted the commenter’s request
for flexibility associated with the 13th
and 19th visit. We believe that
clarifications regarding electronic
signatures are better addressed in
manual guidance. Finally, we will
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implement this provision beginning
April 2011.
Comment: Some commenters urged
CMS to transform the HH PPS therapy
reimbursement model to one based on
clinical outcomes and skill
improvement. A commenter urged CMS
to adopt tests for clinicians, which
assess the clinician’s abilities.
Response: We thank the commenter
for these suggestions. As we described
in earlier comment responses, section
3131(d) of the Affordable Care Act
requires CMS to conduct a study on
costs involved with providing HH
services for patients with high severity
of illness, including analysis of
potential revisions to outlier payments
to better reflect costs of treating
Medicare beneficiaries and analyze
other HH PPS issues determined by the
Secretary. We intend to use this
opportunity to assess a variety of HH
PPS issues, including our current HH
PPS therapy threshold reimbursement.
Comment: A commenter suggested
that CMS consider making access to
physician-ordered medically necessary
music therapy as a covered service.
Response: We thank the commenter
but note that Congress would need to
enact legislation in order to cover music
therapy services under Medicare’s HH
benefit, as they are not currently
covered HH services as defined in
section 1861(m) of the Act.
Comment: Commenters provided
feedback regarding our plans to revise
G-codes to reflect greater detail in the
reporting of skilled nursing and therapy
services. Many commenters requested
more time (6 months to a year or more)
be allowed before these new and revised
codes become effective, so as to give
more time for CMS to provide direction
to HHAs and thus provide time for
agencies to train staff and modify data
collection systems to accommodate
these coding changes. Another
commenter questioned the lead-time to
establish new G-codes, stating that it
would be impossible for all necessary
program changes to be made to all
vendor software within three months.
This commenter requested that CMS
postpone the new and revised G-codes
until 2012 to give agencies and vendors
time to reprogram the requirements. The
commenter also suggested that the types
of descriptions of the codes identified
suggest that CMS wants to use the codes
to determine medically reasonable and
necessary care rather than doing actual
medical review of patient clinical
records. The commenter noted that 60 to
75 percent of claims in which the
appeals are taken to the administrative
law judge level are reversed and
suggested that we already have an issue
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with our medical review and program
integrity units that would be further
exacerbated by the proposed G-codes.
Response: It is important to note that
we provided the information on the new
G-codes to the industry as a prenotification of our intention to collect
additional information on the claim.
The implementation of this provision
will be issued in an administrative
change notice. We note that in
describing our plans in the proposed
rule published on July 23, 2010, we
intended to provided the industry with
early information so that they could
begin planning for this change at that
time. We currently plan to implement
this reporting requirement in January
2011. However, we thank the
commenter, and we will consider this
suggestion.
Comment: Commenters expressed
concern regarding G-code 6, stating that
it has combined two dissimilar activities
and should be split to avoid confusion,
resulting in possible erroneous data.
Specifically, commenters indicated that
a G-code for services for the
management and evaluation of the plan
of care should be separate from a G-code
for the services for the observation and
assessment of a patient’s condition
while a patient’s treatment is stabilized.
Response: We concur with this
suggestion and will adopt the separate
G-codes.
Comment: Some commenters asked
that in revising and adding G-codes for
the reporting of HH services, CMS
should also consider creating codes to
differentiate between the services
provided by a registered nurse (RN) and
a licensed practical nurse (LPN).
Response: We thank the commenters
for this suggestion and will consider
their recommendation in future
rulemaking.
In summary, we thank the many
commenters for their thoughtful and
comprehensive suggestions. After
considering these comments, we will
finalize the proposed therapy coverage
clarifications with several changes. We
will delay the implementation of the
therapy provisions until April 1, 2011,
to allow agencies more transition time.
We will finalize exceptions to the 13th
and 19th qualified therapy visit
requirement to provide some flexibility
associated with patients in rural areas,
patients receiving more than 1 therapy
discipline, and documented exceptional
circumstances which would preclude
the therapist from performing the
needed 13th or 19th visit. We have
made regulatory text changes to remove
confusing scenarios associated with
maintenance therapy, which led
commenters to believe that maintenance
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therapy was a dependent service. We
will finalize numerous other regulation
text changes to clarify that these
changes do not impose new limitations
on the coverage of maintenance therapy.
The changes include clarifications that
when the criteria for maintenance
therapy is met, a qualified therapist
would be assessing the effectiveness of
the therapy provided, rather than the
patient’s progress. Other changes
include the removal of definitions of
rehabilitative therapy which was
confusing to commenters, and other
miscellaneous regulation text
clarifications which were suggested and
we believe improve the clarity of the
regulation text.
C. Outlier Policy
1. Background
Section 1895(b)(5) of the Act allows
for the provision of an addition or
adjustment to the national standardized
60-day case-mix and wage-adjusted
episode payment amounts in the case of
episodes that incur unusually high costs
due to patient HH care needs. Prior to
the enactment of the Affordable Care
Act in March 2010, 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 through 41190),
Medicare provided for outlier payments
not to exceed 5 percent of total
payments and adjusted the payment
rates accordingly.
2. Regulatory Update
In our November 10, 2009 HH PPS
final rule for CY 2010 (74 FR 58080
through 58087), we explained that our
analysis revealed excessive growth in
outlier payments in 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 of an agencylevel cap on outlier payments at 10
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70397
percent of the agency’s total payments,
in concert with a reduced FDL ratio of
0.67. This policy resulted in a projected
target outlier pool of approximately 2.5
percent (the previous outlier pool target
was 5 percent of total HH expenditures).
For CY 2010, we first returned 5 percent
back into the national standardized 60day 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 targeted to 2.5 percent. This
revised outlier policy was adopted for
CY 2010 only.
3. Statutory Update
Section 3131(b)(1) of the Affordable
Care Act amended section 1895(b)(3)(C)
of the Act, ‘‘Adjustment for outliers,’’ to
state, ‘‘The Secretary shall reduce the
standard prospective payment amount
(or amounts) under this paragraph
applicable to HH 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
amended section 1895(b)(5) of the Act
by redesignating the existing language
as section 1895(b)(5)(A) of the Act, and
revising it to state 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, our
HH PPS outlier policy must reduce
payment rates by 5 percent, and target
up to 2.5 percent of total estimated HH
PPS payments to be paid as outlier
payments. We will first return the 2.5
percent held for the target CY 2010
outlier pool to the national standardized
60-day episode rates, the national pervisit rates, the LUPA add-on payment
amount, and the NRS conversion factor
for CY 2010. We will then reduce these
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
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or estimated to be made based on the
PPS 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.
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4. Outlier Cap
As stated earlier, for CY 2010, we
implemented an agency-level cap by
limiting HH outlier payments to be a
maximum of 10 percent of an agency’s
total payments (74 FR 58080 through
58087). Section 3131(b)(2)(C) of the
Affordable Care Act makes this 10
percent agency-level cap a permanent
statutory requirement, by adding 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 HHA 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 (without regard
to this paragraph) with respect to the
HH agency for the year’’. Therefore, the
10 percent agency-level outlier cap
would continue in CY 2011 and
subsequent calendar years as required
by section 1895(b)(5)(B) of the Act, as
added by section 3131(b)(2)(C) of the
Affordable Care Act. In summary,
section 3131(b) of the Affordable Care
Act requires the following outlier
policy: (1) Reduce the estimated total
payments by 5 percent; (2) target to pay
no more than 2.5 percent of estimated
total payments for outliers; and (3)
apply a 10 percent agency-level outlier
cap.
5. Loss-Sharing Ratio and Fixed Dollar
Loss (FDL) Ratio
The July 2000 final rule (65 FR 41189)
described a methodology for
determining outlier payments. Under
this system, outlier payments are made
for episodes whose estimated cost
exceeds a threshold amount. The
payment rate for a 60-day episode is the
sum of the wage-adjusted national pervisit rate amounts for all visits delivered
during the episode. The outlier
threshold is defined as the sum of the
episode payment rate for that case-mix
group and a 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 resulting amount.
The wage-adjusted FDL amount is then
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added to the wage-adjusted 60-day
episode payment rate to arrive at the
wage-adjusted outlier threshold amount.
The outlier payment is defined as a
proportion of the wage-adjusted
estimated costs beyond the wageadjusted outlier threshold amount. The
proportion of additional costs paid as
outlier payments is referred to as the
loss-sharing ratio. Prior to the passage of
the Affordable Care Act, the FDL ratio
and the loss-sharing ratio were selected
so that the estimated total outlier
payments would not exceed the 5
percent aggregate 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 wageadjusted outlier threshold amount. A
loss-sharing ratio of 0.80 is also
consistent with the loss-sharing ratios
used in other Medicare PPS outlier
policies, such as inpatient hospital,
inpatient rehabilitation, long-term
hospital, and inpatient psychiatric
payment systems.
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 ratio and the
loss-sharing ratio. For a given level of
outlier payments, a higher FDL ratio sets
higher FDL amounts and thus reduces
the number of cases that receive outlier
payments, but allows for setting a higher
loss-sharing ratio and higher outlier
payments per episode. Alternatively, a
lower FDL ratio means lower FDL
amounts and therefore allows more
episodes to qualify for outlier payments
but setting a lower loss-sharing ratio and
lower outlier payments per episode.
Therefore, setting these two
parameters (that is, FDL ratio and losssharing ratio) involves policy choices
about the number of outlier cases and
their payments. In the CY 2010 HH PPS
final rule (74 FR 58086), in targeting
total outlier payments as 2.5 percent of
total HH PPS payments, we
implemented a FDL ratio of 0.67.
For this 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 target paid
outlier payments to be no more than the
2.5 percent 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.
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The following is a summary of the
comments we received regarding the
outlier payment policy.
Comment: A commenter supported
CMS in its efforts to curb fraud and
abuse in the Medicare program. The
commenter is not opposed to the
proposed implementation of these
changes to the outlier policy. However,
the commenter cautioned CMS to
carefully analyze the effect this outlier
policy might have on HHAs in rural and
underserved areas. Often times, patients
who are sicker and more clinically
complex may be treated in the HH
setting due to lack of access to other
post-acute care settings. HHAs treating
such patients would have higher outlier
costs than HHAs that are located in
urban and higher socioeconomic areas.
The commenter strongly urged CMS to
ensure that these HHAs were not
unfairly audited or penalized for the
treatment furnished to these patients.
Another commenter stated that some
remote rural areas have only one agency
per county and many counties have no
HHAs. In such rural areas, there would
be no other agency to share intake of
clients who have costly outlier episodes.
State regulations for Medicaid or
assisted living programs could force
clients to be admitted to a nursing home
because agencies in these remote rural
markets might not be able to afford to
provide care for them. The commenter
further urges that small HHAs (that is,
those with fewer than 300 patients) in
remote rural areas should be exempt
from the agency-level outlier cap or
have a higher cap. Another commenter
recommended exempting agencies with
fewer than 60 Medicare patients per
year from the outlier policy since even
one or two outlier episodes could easily
reach the cap. This policy could force
some small HHAs to refuse care to
patients who are most in need of care.
Response: We will take these
comments into consideration when we
conduct our study on costs involved
with providing ongoing access to HH
services for patients with high severity
of illness, as required by the Affordable
Care Act.
Comment: Several commenters stated
that the proposed outlier policy is unfair
because all agencies are held
accountable for the unscrupulous
behavior of a few agencies. The
commenters believed that CMS is taking
a broad stroke approach to
implementing changes that could be
detrimental to the many agencies that
are operating appropriately and in
compliance with the regulations. A
commenter stated that the outlier policy
would further reduce patient access and
would fail to target the abusers. Several
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commenters stated that the legislative
limit placed on the outlier pool would
punish all agencies for the outlier policy
abuse of a very limited number of
agencies. Several commenters
recommended restoring the 2.5 percent
reduction to the payment rates. Another
commenter stated that the proposed cut
of 2.5 percent to the base payment for
all HHAs in order to ‘‘pay’’ for this
policy was unfair and excessive,
especially considering other proposed
cuts. The commenter recommended that
CMS limit any single year rate
reductions including statutory
reductions and case-mix change
adjustments to no greater than an
aggregate 2.5 percent. Another
commenter noted that the Affordable
Care Act mandated that the reduction in
payments for outliers be 5 percent and
that the outlier target be 2.5 percent of
total payments. As the difference of 2.5
percent remains unallocated in the
proposed rule, the commenter suggested
that CMS redesignate that difference to
the proposed 3.79 percent decrease for
case-mix change, resulting in a case-mix
adjustment of 1.29 percent decrease.
Otherwise, the CY 2011 HHA rate will
be hit twice—by the 3.79 percent casemix decrease and the 2.5 percent outlier
pool decrease. Another commenter
stated that HHAs have already sustained
a significant cut in outlier payments,
leaving insulin dependent and wound
care patients without a nurse to provide
injections and necessary wound care
treatment. At any given time, an agency
cannot assess whether it has the
resources to accept these types of
patients. A commenter requested that
CMS exempt ‘‘special needs’’ HHAs that
serve high-cost patients with multiple
clinical issues from the 10 percent
agency-level outlier cap. The
commenter believed a revision to a
higher outlier cap is critical for
continued provision of care by agencies
serving high-need and high-cost
beneficiaries without losing critical
outlier funding.
Response: Section 3131(b) of the
Affordable Care Act does not allow for
exceptions to the mandate of the outlier
policy which reduces estimated
aggregate HH payments by 5 percent,
allows no more than an estimated 2.5
percent of aggregate HH payments to be
outlier payments, and requires the 10
percent agency-level outlier cap. We do
not have regulatory authority to restore
the 2.5 percent to the estimated
aggregate HH payments. Nonetheless,
we will continue to monitor outlier
70399
payments in order to advise the
legislators of any unintended
consequences of this legislation, such as
lack of access to care.
Comment: A commenter stated that he
interpreted Table 4 in the July 23, 2010
proposed rule (75 FR 43257) to indicate
that each year HHAs can expect an
additional 2.5 percent reduction to the
base episode rate starting from the prior
year’s base rate before the market basket
update. This additional rolling
reduction does not seem contemplated
in the Affordable Care Act. A
commenter stated that the 2.5 percent
rate reduction combined with the
standard 3 percent inflation/cost of
living increases demanded by their
employees will result in their agency
being unable to hire staff to serve their
patients. CMS does not identify actual
outlier payment history when
addressing these changes in the rule.
Response: The 2.5 percent reduction
is not a rolling reduction. The 2.5
percent reduction is a one-time, but
permanent, reduction to the HH rates,
which is to be applied in CY 2011.
Table 3 shows outlier payment history
as a percentage of total HH PPS
payments between CY 2004 and CY
2008.
TABLE 3—OUTLIER PAYMENT HISTORY AS A PERCENTAGE OF TOTAL HH PPS PAYMENTS
[Between CY 2004 and CY 2008]
Outlier
payment
Year
2004
2005
2006
2007
2008
.........................................................................................................................................
.........................................................................................................................................
.........................................................................................................................................
.........................................................................................................................................
.........................................................................................................................................
Comment: A commenter stated that
the outlier policy will significantly
decrease fraudulent behavior within the
Miami-Dade, Florida area. The
commenter further supports more open
dialogue between the HH community
and government officials to improve
program integrity within the Medicare
program.
Response: We appreciate the
comment and the commenter’s support.
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6. Imputed Costs
Section 3131(d) of the Affordable Care
Act requires CMS to conduct a study on
costs involved with providing HH
services for patients with high severity
of illness, including analysis of
potential revisions to outlier payments
to better reflect costs of treating
Medicare beneficiaries. CMS will
produce a Report to the Congress
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containing this study’s
recommendations no later than March 1,
2014.
To consider outlier policy
improvements in the nearer term, we
solicited comments regarding alternate
policy options and methodologies to
better account for high cost patients. In
particular, we solicited the industry’s
input on alternatives in imputing 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
solicited feedback concerning the use of
diagnoses codes (for example, diabetes)
as a factor in the calculation of imputed
costs associated with outlier payments.
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Total HH PPS
payment
$309,198,604
527,096,653
701,945,386
996,316,407
1,127,162,152
$11,500,462,624
12,885,434,951
14,041,853,560
15,677,329,001
17,114,906,875
Percentage
change
2.69
4.09
5.00
6.36
6.59
We believe that modifying the fixed
dollar loss ratio or the loss-sharing ratio
now would not improve the current
policy. However, we welcome industry
comments on such potential
modifications.
The following is a summary of the
comments we received regarding
imputed costs.
Comment: Several commenters stated
that visit intensity data or diagnoses are
not the only issues impacting outliers.
CMS should consider a comprehensive
look at resource utilization which might
include these factors. Another
commenter stated that the proposed rule
does not specify how ‘‘visit intensity’’ is
to be measured, such as whether the
length of the visit or the frequency of
visits would be measured. Several
commenters stated that in addition to
intensity data and diagnoses, resource
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utilization, and other factors affect costs
for an outlier episode and should be
taken into consideration.
Another commenter suggested using
actual, inflation-adjusted, agencyspecific costs for each discipline rather
than the imputed LUPA rates currently
used to calculate the outlier payment.
Calculations using such costs would
reduce abuse by agencies that game the
system by providing excessive numbers
of visits at visit costs below the LUPA
rate. Using actual costs versus imputed
costs would better estimate the needs of
patients who are severely impaired.
Continued use of imputed costs to
administer the outlier leaves the
program vulnerable to abuse while
simultaneously compromising the
usefulness of the outlier costs concept
for seriously ill patients of reputable
agencies.
Response: We appreciate these
comments and will take them into
consideration when we conduct a study
of outlier payments required by the
Affordable Care Act. We will produce a
Report to the Congress containing this
study’s recommendations no later than
March 1, 2014.
D. CY 2011 Rate Update
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1. Home Health Market Basket Update
Section 1895(b)(3)(B) of the Act
requires that the standard prospective
payment amounts for CY 2011 be
increased by a factor equal to the
applicable HH 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 HH
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 HH 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 following is a summary of the
comments we received regarding the HH
market basket update.
Comment: A commenter believes that
the market basket index fails to include
consideration of the direct cost
increases that CMS rules may have on
the delivery of care. Instead, the index
evaluates general cost changes such as
the cost of caregivers, transportation,
insurance, and office space. This
approach does not provide CMS with
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sufficient information to adjust payment
rates in relation to regulatory cost
increases.
When the HH services ‘‘product’’
changes because of new regulatory
requirements, CMS should include in
the market basket index an element to
address the resulting cost changes.
Alternatively, CMS should adjust base
payment rates to account for such cost
changes as done previously for costs
associated with OASIS.
Response: The HH market basket is
not designed to account for changes in
total costs (such as those associated
with the implementation of OASIS–C or
other initiatives), but is rather intended
to measure the input price pressures
that the average HH provider is
expected to face in the coming year.
The composition of the market basket
itself is made up of a set of mutually
exclusive and exhaustive cost categories
that reflect the cost structure of the
industry (in a given base year). The HH
index’s cost shares (or weights) are
based on data reported on the Medicare
cost report forms and are specific to
HHAs. Each cost category is assigned an
appropriate price proxy whose projected
movements are weighted by their
respective cost shares and aggregated to
arrive at the actual market basket
update.
Any cost increases that a provider
bears based on regulatory requirements
must be reflected in the increasing costs
of the inputs on provision of the service.
When the market basket is rebased, cost
changes will be accounted for in the
data, up to and including the base year.
We evaluate the cost weight
distributions on a periodic basis. If the
cost structure of the HH industry
changes, such as a greater share of
expenses being devoted to wages and
salaries, we will propose to rebase and
revise the market basket, as appropriate.
Comment: A commenter states that
the continued reductions to the home
health market basket update each year
for 2011, 2012, and 2013 are drastic.
These cuts come at a time when labor
costs—particularly nurses and
therapist—continue to rise.
Response: Since publication of the CY
2011 HH PPS proposed rule, we have
updated the HH market basket increase
for CY 2011. The updated HH market
basket increase is 2.1 percent, which is
based on IHS Global Insight Inc.’s third
quarter 2010 forecast, utilizing historical
data through the second quarter of 2010.
A detailed description of the
methodology used to derive the HH
market basket is available in the CY
2008 HH PPS proposed rule (72 FR
25356, 25435). Due to the new
requirement at section 1895(b)(3)(B)(vi)
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of the Act, the CY 2011 market basket
update of 2.1 percent must be reduced
by 1 percentage point to 1.1 percent. In
effect, the CY 2011 market basket
update is 1.1 percent. The statute does
not permit us to exercise any discretion
with respect to the application of this
percentage point 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 HHA
that does not submit data to the
Secretary in accordance with sub clause
(II) with respect to such a year, the HH
market basket percentage increase
applicable under such clause for such
year shall be reduced by 2 percentage
points.’’ This requirement has been
codified in regulations at § 484.225(i).
Accordingly, for CY 2011, we will
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. For
CY 2011, we proposed 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 allows for 12 full
months of data collection and would
provide us the time necessary to analyze
and make any necessary payment
adjustments to the payment rates in CY
2011. We will 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)
(§ 484.200 through 484.265), as well as
those excluded, as described in the
Final Rule Medicare and Medicaid
Programs: Reporting Outcome and
Assessment Information Set Data as Part
of the Conditions of Participation for
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Home Health Agencies December 23,
2005 (70 FR 76202) as follows:
• Those patients receiving only nonskilled services;
• Neither Medicare nor Medicaid is
paying for HH 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
(72 FR 49863), agencies that become
Medicare-certified on or after May 1 of
the preceding year (2010 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 HH market
basket percentage increase. HHAs that
do not meet the reporting requirements
would be subject to a 2 percent
reduction to the HH market basket
increase in conjunction with applicable
provisions of the Affordable Care Act, as
discussed in the section II.X. of this
final rule ‘‘CY 2011 Payment Update.’’
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 HHA 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 will 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
HH quality.
To meet the requirement for making
such data public, we will continue to
use 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 later.
The Home Health Compare Web site,
which is scheduled to be redesigned
this Fall is located at https://
www.medicare.gov/HHCompare/
Home.asp. Each HHA currently has prepublication access, through the CMS
contractor, to its own quality data, as
the contractor updates this periodically.
We will continue this process, to enable
each agency to view its quality measures
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before public posting of data on Home
Health Compare Web site.
The following 12 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 will continue to use specified
measures derived from the OASIS data
for purposes of measuring HH 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.
We have changed the set of OASIS
outcome measures that will be publicly
reported beginning in July 2011 to
include the following outcome measure:
• 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 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 HH
quality measures, this measure is
endorsed by the National Quality Forum
(NQF).
As previously stated, although NQF
endorsement is not required for public
reporting, we will 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 the following:
• Discharge to community;
• Improvement in Urinary
Incontinence; and
• Emergent Care for Wound
Infections, Deteriorating Wound Status.
We solicited comments on these
measures in the CY 2011 HH PPS
proposed rule.
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Additionally, the change to OASIS–C
results in modifications to two of the
outcome measures as follows:
• 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, the following outcome
measures, which comprise measurement
of HH care quality, will 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; and
• 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 is on the CMS Web
site at https://www.cms.hhs.gov/
HomeHealthQualityInits/12_
HHQIOASISDataSet.asp#TopOfPage.
As a result of changes to the OASIS
data set, process of care measures are
available as additional measures of HH
quality. We published information
about new process measures in the
August 13, 2009 proposed rule (74 FR
40960) and in the November 10, 2009
final rule with comment period (74 FR
58096). We proposed and made final the
decision to update the Home Health
Compare Web site 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;
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• Diabetic foot care and patient
education implemented during shortterm 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 the Home Health Compare Web site
and the contractor outcome reports used
for HHA’s performance improvement
activities) will remain static with
OASIS–B1 data. The last available
OASIS–B1 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 can be inaccurate and
misleading due to issues like seasonal
variation and under-representation of
long-stay HH patients. Once sufficient
OASIS–C data have been collected and
submitted to the national repository, we
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 continue to be available after
March 2010. OASIS–C process measures
are available to preview as of 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.
The following is a summary of the
comments we received regarding the
Home Health Care Quality
Improvement: OASIS proposal.
Comment: One commenter expressed
support for the proposed changes in
OASIS reporting. Another commenter
stated support for quality reporting.
Commenters also stated they support
the changes in OASIS publicly reported
indicators and expressed support for the
continued submission of OASIS data
and expressed their commitment to
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continue working with CMS to develop
appropriate measures. Commenters also
support the adoption of OASIS–C
process measures and applaud CMS for
creating this patient-focused system.
Response: We appreciate the positive
feedback regarding changes in the
measures which will be publicly
reported and the quality reporting
efforts in general. We appreciate the
industry’s encouragement and
willingness to adopt the new methods
that reflect the quality of care provided
to Medicare beneficiaries.
Comment: One commenter expressed
concern with the addition of the
Increase in Number of Pressure Ulcers
measure to publicly reported outcomes.
The commenter stated that it is not an
appropriate measure of the homecare
agencies’ effectiveness of care but rather
of the family’s effectiveness and that
HHAs are not responsible for the care
provided 24 hours a day.
Response: Though HH services are
provided on an intermittent, part-time
basis, and HHA staff are not present in
the home 24 hours per day, the HHA is
responsible for determining that the
level of care provided by the agency is
safe and adequate to manage the needs
of the patient. Monitoring and
addressing adherence to the Plan of Care
established by the physician, HHA,
patient, and family is the responsibility
of the HHA. In many cases, though we
agree not all, the provision of skilled
nursing services, which includes
family/caregiver instruction, in
conjunction with the provision of
personal care services, can accomplish a
great deal in the prevention of new
pressure ulcers. We believe this is an
important indicator of HHA
performance related to best practices,
patient safety, and comfort. This
measure is also harmonized with similar
measures in other settings. We will
move forward with reporting Increase in
Number of Pressure Ulcers on Home
Health Compare in July 2011.
Comment: One commenter urged
CMS to maintain ‘‘Improvement in
Urinary Incontinence’’ among the
publicly reported outcome measures,
stating that this measure is of utmost
importance to Medicare beneficiaries’
quality of life and Medicare costs.
Another commenter expressed
disappointment in the removal of the
outcome measure ‘‘Discharge to
Community’’ from public reporting,
stating their belief that this measure is
one of the best measures of the
effectiveness of HHA intervention.
Response: The Improvement in
Urinary Incontinence outcome measure
did not receive endorsement from NQF
when reviewed in March 2009. NQF’s
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rationale primarily involved concerns
about reliability of the data, that is, that
this information is difficult to capture
reliably due to issues with patient
reporting. We have also received
feedback from providers and consumers,
which leads us to believe that the
measure lacks salience and meaningful
use, particularly among consumers. It
appears that consumers are unable to
link this outcome to the HHA’s
performance and cannot attribute
improvement to HHA care.
The Discharge to Community measure
also did not receive endorsement from
NQF when reviewed in March 2009.
NQF determined that this measure did
not reflect whether patients met their
treatment goals, but only that they were
discharged from services, which may
have been for other reasons unrelated to
the care provided. NQF also noted that
the acute care hospitalization measure
captures many of these patients.
However, the comments offered do
present meaningful information that we
will find useful when considering
resubmitting these measures for NQF
endorsement. Please note that these
measures will continue to be provided
to agencies for use in quality/
performance improvement efforts.
Comment: One commenter
recommended CMS consider ending the
requirement that OASIS data be
submitted for Medicare Advantage (MA)
plans, noting that that they have not
found an MA plan that has used the data
in the past decade.
Response: Under section 1891(b) of
the Act, the Secretary is responsible for
assuring that the Conditions of
Participation (CoPs) and their
enforcement are adequate to protect the
health and safety of individuals under
the care of an HHA and to promote the
effective and efficient use of Medicare
funds. Medicare funds are used to pay
for care provided to patients covered by
MA plans.
Under sections 1861(o), 1871, and
1891 of the Act, the Secretary has
established in regulations the
requirements that an HHA must meet to
participate in the Medicare program.
These requirements are set forth at 42
CFR Part 484, Conditions of
Participation: Home Health Agencies.
The current HH CoPs require that all
HHAs participating in Medicare and
Medicaid (including managed care
organizations providing HH services to
Medicare and Medicaid beneficiaries)
collect and report OASIS data on adult,
non-maternity patients receiving skilled
care.
One of the major purposes of
collecting and reporting OASIS data is
to track the quality of patient outcomes.
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It is important that the content of
reports depicting the status of patient
outcomes and the HHA use of best
practices include measures related to all
Medicare beneficiaries, including those
covered by MA Plans. It is also
important to include MA beneficiary
data in the calculation of agency, state,
and national averages in both agency
level and public quality measure
reports. This quality information is
available for use and is actually used
not only by payers, but also by
researchers, providers, and consumers
of HH services. We are not currently
considering a change in the OASIS
reporting requirements.
Comment: Two commenters urge that
CMS remove New York State’s LTHHCP
agencies from the Pay for Reporting
(P4R) initiative in order to ensure that
these programs will not be adversely/
unfairly affected or penalized once CMS
implements a Pay for Performance
system. The commenter also requests
that any special needs CHHAs be
removed from the P4R initiative for the
same reasons.
Response: The Pay for Reporting
initiative requires that all Medicare
certified HHAs submit OASIS
assessments. The HH P4R requirements
are based in section 5201(c)(2) of the
DRA, which provides for an adjustment
to the HH market basket percentage
update depending on their submission
of quality data. HHAs that submit the
required quality data using OASIS will
receive payments based on the full HH
market basket update each calendar
year. If a HHA does not submit quality
data, the HH market basket will be
reduced by 2 percentage points based on
annual payment rule and the Congress.
The submission of OASIS assessments
is also required by the CoPs and as a
Condition of Payment. The only
exceptions to the reporting requirements
are:
• Prepartum and postpartum patients;
• Patients under the age of 18;
• Patients not receiving skilled health
care services; and
• Non-Medicare/non-Medicaid
patients (patients receiving care under a
Medicare or Medicaid Managed Care
Plan are not excluded from the OASIS
reporting requirement).
Since New York’s LTHHCP agencies
or any special needs CHHAs do not fall
within these exclusions, we are not
waiving their reporting requirements.
The Affordable Care Act requires that
we submit a Report to Congress
outlining a Value Based Purchasing Plan
for HHAs by October, 1, 2011. We are
in the process of developing the Home
Health Value Based Purchasing report
and decisions have not yet been made
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about this issue. Therefore, it would be
premature to link a Pay for Performance
system to OASIS submission at this
time.
Comment: One commenter expressed
concern that it is too soon to publicly
report the new OASIS–C process
measures and request an additional year
of study and refinement before these
measures are released to the public. The
commenter also states that most
agencies have no way to identify where
they stand with regard to the process
items and that many of these items
remain problematic and confusing to
providers.
Response: The process measure
reports, which detail the 47 new process
measures based on OASIS–C, were
made available to HHAs via the
CASPER reporting system as of
September 1, 2010. The availability of
these reports meets the statutory
requirement that HHAs have
opportunity to view their measures
prior to public reporting. Thirteen of the
process measures were posted on Home
Health Compare in October 2010.
We recognize that agencies have
experienced many changes with the
transition to OASIS–C on January 1,
2010 and will need to continue to make
adjustments to move their newly
measured performance forward. These
changes and adjustments are all
intended to improve the care provided
to beneficiaries and to provide best
practices that HHAs may choose to
implement for their HH patients.
Process measures are mechanisms for
assessing the degree to which a provider
competently and safely delivers clinical
services that are appropriate for the
patient in the optimal time period.
Through efforts over time, HHAs should
see improvements in their process
measure reports, including those that
are publicly reported. Recognizing that
the first set of reports will provide the
baseline of performance on which HHAs
can build, we will continue with the
proposed reporting plan and timeline.
There are several resources available
to assist with any remaining confusion
within the HH industry related to the
process items that include the
following:
• In 2009, CMS provided three Train
the Trainer calls via the Medicare
Learning Network one of which focused
on process items and measures. All
three transcripts are still available at
https://www.cms.gov/
HomeHealthQualityInits/03_
EducationalResources.asp#TopOfPage.
• A new training video specific to
Process-Based Quality Improvement
(PBQI) is now available on YouTube at
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70403
https://www.youtube.com/
watch?v=hNno1GIVAPA.
• Four new and/or revised manuals
are also available as downloads from the
Home Health Quality Initiatives site at
https://www.cms.gov/
HomeHealthQualityInits/.
• For questions regarding the OASIS
items, the OASIS Answers mailbox can
be accessed at
cmsoasisquestions@oasisanswers.com.
Comment: One commenter expressed
concern with the increased demands
placed upon HHAs to provide
information regarding the quality of
their services, and that possibly these
newer requirements are unfair to HHAs
that are honestly trying to provide good
services and that agencies would stop
admitting patients that are in dire need
of HH services because outcomes would
not be good. The commenter was
concerned at the presence of
unscrupulous HHAs that are taking
advantage of seniors who are deserving
of quality HH care, and advised CMS to
be more cautious as to whom they let
into the program. Another commenter
stated that OASIS is very time
consuming and the addition of
HHCAHPs is ‘‘enough.’’ Some
commenters suggested that OASIS–C,
HHCAHPS, and general Quality
Management requirements are unfunded
mandates; that are very costly to
implement. One commenter expressed
concern that there is no mention of risk
adjustments on publicly reported data.
Another commenter noted that neither
quality measures nor HHCAHPS address
communication or swallowing
capabilities.
Response: We appreciate these
commenters’ concerns about fraudulent
HH providers. We are also aware that
newer requirements, such as OASIS–C
and HHCAHPS, may be perceived as an
additional and burdensome
responsibility that HHAs now have.
However, we believe that both the
OASIS–C process measures and
HHCAHPS will be very useful to both
HH beneficiaries and HHAs. Recipients
of HH services will have access to more
information about the quality of HH
care. HHAs can utilize the data gleaned
from these new requirements for their
internal quality improvement purposes,
which will assist them as businesses
and providers. The HH quality
requirements are intended to provide
improved support for agency quality
improvement efforts and enhanced
quality information for both providers
and beneficiaries. Process of care items
that measure agencies’ use of evidencebased practices that have been shown to
prevent exacerbation of serious
conditions can improve care received by
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individual patients and can provide
guidance to agencies on how to improve
care and avoid adverse events.
Regarding the addition of process
measures and best practices, it is also
important to note that HHAs are
encouraged to use these best care
practices but they are not mandated
under the current CoPs.
With the exception of requiring that
the item be included on the assessment
form and answered, we are not
prescribing the content of agency
clinical assessments or mandating
specific processes of care. There is no
requirement for agencies to change their
care processes to match the evidencebased practices measured in the OASIS
C. It is up to each agency to determine
which practices it will implement based
on its own patients and operations.
Regarding risk adjustment, all outcome
measures will be risk adjusted for HHA
reports and for public reporting.
Regarding the absence of measures
related to communication and
swallowing, the development of both
quality measures and patient
satisfaction questions are dynamic
processes and we will consider these
categories in our future efforts.
After considering the comments
submitted, we have decided to finalize
what was originally proposed.
b. Home Health Care CAHPS Survey
(HHCAHPS)
In the HH PPS Rate Update for CY
2010 final rule (74 FR 58078), we
expanded the HH quality measures
reporting requirements for Medicarecertified agencies to include the
CAHPS® Home Health Care (HHCAHPS)
Survey for the CY 2012 annual payment
update (APU). We are maintaining our
existing policy as promulgated in the
HH PPS Rate Update for CY 2010, and
are moving forward with its plans for
HHCAHPS linkage to the P4R
requirements affecting the HH PPS rate
update for CY 2012.
As part of the U.S. Department of
Health and Human Services’ (DHHS)
Transparency Initiative, we have
implemented a process to measure and
publicly report patient experiences with
HH care using a survey developed by
the Agency for Healthcare Research and
Quality’s (AHRQ’s) Consumer
Assessment of Healthcare Providers and
Systems (CAHPS®) program. The
HHCAHPS survey is part of a family of
CAHPS® surveys that asks patients to
report on and rate their experiences
with health care. The HHCAHPS survey
presents HH patients with a set of
standardized questions about their HH
care providers and about the quality of
their HH care. Prior to this survey, there
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was no national standard for collecting
information about patient experiences
that would enable valid comparisons
across all HHAs.
(i) Background and Description of the
HHCAHPS
AHRQ, in collaboration with its
CAHPS grantees, developed the
CAHPS® 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 HH care). The
HHCAHPS survey was designed to
measure and assess the experiences of
those persons receiving HH 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® Home Health
Care Survey. We submitted the survey
to the 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 HH
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:
• Patient care
• Communications between providers
and patients
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• 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 or her willingness to recommend the
HHA to family and friends.
The survey is currently available in
five languages. At the time of the CY
2010 HH PPS final rule published on
November 10, 2009, HHCAHPS was
only available in English and Spanish
translations. In the proposed rule for CY
2010, we stated that CMS would
provide additional translations of the
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 HH patient population.
The following types of HH care
patients are eligible to participate in the
HHCAHPS survey:
• Current or discharged Medicare
and/or Medicaid patients who had at
least one skilled HH 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 HH care; and
• Patients who have not requested
‘‘no publicity status.’’
We are maintaining for the CY 2012
APU 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 survey vendors.
The application process is 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 40 approved HHCAHPS
survey vendors. In this rule, we also
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codify the requirements for being an
approved HHCAHPS survey vendor for
the CY 2013 APU.
HHAs started to participate in
HHCAHPS on a voluntary basis
beginning in October 2009. We define
‘‘voluntary participation’’ as meaning
that HHCAHPS participation is not
attached to the quality reporting
requirement for the APU. These
agencies selected a vendor from the list
of HHCAHPS approved survey vendors,
which is available at https://
www.homehealthcahps.org.
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(ii) 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 the Hospital Compare
Web site, where the patients’
perspectives of care data from HCAHPS
are displayed along with the hospital
clinical measures of quality. We believe
that the HHCAHPS will enhance the
information included in Home Health
Compare by providing Medicare
beneficiaries a greater ability to compare
the quality of HHAs. We anticipate that
the first reporting of HHCAHPS data
will be in spring/summer 2011. The first
reporting of HHCAHPS data will
include data that were collected in the
voluntary period of HHCAHPS data
collection (October 2009 through
September 2010), prior to the period
when HHCAHPS data collection will
count toward the 2012 APU
requirements. HHAs will be able to
suppress the public reporting of data
collected in the voluntary period of data
collection.
(iii) Participation Requirements for CY
2012: The Consumer Assessment of
Healthcare Providers and Systems
(CAHPS®) Home Health Care Survey
In the CY 2010 HH PPS final rule (74
FR 58078, et seq.), we stated that
HHCAHPS would not be required for
the APU for CY 2011. However, we
stated that data collection should take
place beginning in CY 2010 in order to
meet the HHCAHPS reporting
requirements for the CY 2012 APU
Medicare-certified agencies were asked
to participate in a dry run for at least 1
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 at https://
www.homehealthcahps.org.
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The dry run data should be submitted
to the Home Health CAHPS® Data
Center by 11:59 p.m., Eastern Standard
Time 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® Data Center.
The mandatory period of data
collection for the CY 2012 APU includes
the dry run data in the third quarter
2010, data from the fourth quarter 2010
(October, November and December
2010), and data from the first quarter
2011 (January, February and March
2011). 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® Data Center by 11:59
p.m., Eastern Daylight Time on April 21,
2011. The data from the 3 months of the
first quarter 2011 should be submitted
to the Home Health CAHPS® Data
Center by 11:59 p.m., Eastern Daylight
Time on July 21, 2011. These data
submission deadlines are firm (that is,
no late submissions will be accepted).
These periods (a dry run in third
quarter 2010, and 6 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 should target 300
completed HHCAHPS survey 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 mailonly and mixed-mode surveys, data
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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 data collection to meet
the CY 2012 APU requirements.
As stated in the CY 2010 HH PPS final
rule (74 FR 58078), we would exempt
Medicare-certified HHAs certified on or
after April 1, 2011 from the HHCAHPS
reporting requirements for CY 2012 as
data submission and analysis will not be
possible for an agency this late in the
reporting period for the CY 2012 APU
requirements.
We would also exempt Medicarecertified 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
HH PPS 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 on the Web site at
https://www.homehealthcahps.org. This
patient counts reporting 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 APU in CY 2012. In this
rule, we codify the requirement that if
an HHA has fewer than 60 eligible
unique HHCAHPS patients annually,
then they must submit to CMS their
total patient counts 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
HH 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 data
collection requirements. We proposed
that these procedures will be detailed in
the CY 2012 HH payment rule, the
period for which HHCAHPS data
collection would be required for the HH
market basket percentage increase.
During September through October
2011, we will compile a list of HHAs
that are not compliant with OASIS–C
and/or HHCAHPS for the 2012 APU
requirements. These HHAs would
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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
data requirements for CY 2012 payment
rates. HHAs have a right to appeal to the
Prospective Reimbursement Review
Board (PRRB) if they are not satisfied
with the CMS determination.
(iv) Oversight Activities for the
Consumer Assessment of Healthcare
Providers and Systems (CAHPS®) 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. As stated, all
approved survey vendors must 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 onsite work and of all subcontractors
work; and
• Confidentiality/Privacy and
Security procedures in accordance with
the Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
(Pub. L. 104–191, enacted on August 21,
1996).
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 at 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 the following
• Survey management and data
systems;
• Printing and mailing materials and
facilities;
• Data receipt, entry and storage
facilities; and
• Written documentation of survey
processes. Organizations would be given
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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.
(v) HHCAHPS Requirements for CY
2013
For the CY 2013 APU, we will begin
to require that four quarters of data for
HHCAHPS be collected and reported.
The data collection period would
include second quarter 2011 through
first quarter 2012. HHAs will be
required to submit to the Home Health
CAHPS Data Center data for the second
quarter 2011 by 11:59 p.m., Eastern
Daylight Time on October 21, 2011; for
the third quarter 2011 by 11:59 p.m.,
Eastern Standard Time on January 21,
2012; for the fourth quarter 2011 by
11:59 p.m., Eastern Daylight Time on
April 21, 2012; and for the first quarter
2012 by 11:59 p.m., Eastern Daylight
Time on July 21, 2012.
As noted, we exempt HHAs receiving
Medicare certification on or after April
1, 2012 from the full HHCAHPS
reporting requirement for the CY 2013
APU, as data submission and analysis
will not be possible for an agency that
late in the reporting period for the CY
2013 APU requirements. However, we
require that new HHAs that receive
Medicare certification during CY 2012
begin HHCAHPS data collection and
submission the quarter following receipt
of the CMS Certification Number (CCN)
in order to receive the CY 2013 APU.
As noted, we require that all HHAs
that have fewer than 60 HHCAHPSeligible unduplicated or unique patients
in the period of April 1, 2010 through
March 31, 2011 will be exempt from the
HHCAHPS data collection and
submission requirements for the CY
2013 APU. For the CY 2013 APU,
agencies with fewer than 60 HHCAHPSeligible, 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 11:59 p.m., e.s.t. on January 21, 2012.
This deadline is firm, as are all of the
quarterly data submission deadlines.
We proposed to codify the HHCAHPS
survey vendor requirements to be
effective with the CY 2013 APU. In our
regulation, we are stating in
§ 484.250(c)(2) that applicants to
become approved HHCAHPS survey
vendors must have been in business for
a minimum of 3 years and have
conducted ‘‘surveys of individuals’’ for
at least 2 years immediately preceding
the application to become a survey
vendor for HHCAHPS. For purposes of
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the approval process for HHCAHPS
survey vendors, a ‘‘survey of
individuals’’ is 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],
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 for
at least two years, in which statistical
samples of individuals were selected. 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 also proposed that the following
examples of data collection activities
would not satisfy the requirement of
valid survey experience for approved
vendors as defined for the HHCAHPS,
and these would not be considered as
part of the experience required of an
approved vendor for HHCAHPS:
• 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 also proposed to codify the
criteria that would make organizations
ineligible to become HHCAHPS
approved survey vendors. We proposed
to require that any organization that
owns, operates, or provides staffing for
a HHA not be permitted to administer
its own HHCAHPS Survey or administer
the survey on behalf of any other HHA.
We began the HHCAHPS with the belief,
based on input from many stakeholders
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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 HH patients receive care in their
homes, this survey population is
particularly vulnerable and dependent
upon their HHA caregivers. Therefore,
in § 484.250(c), we proposed to require
that HHAs contract only with an
independent, approved HHCAHPS
vendor to administer the HHCAHPS
survey on their behalf. Furthermore, in
§ 484.250(c)(2), we stated that ‘‘No
organization, firm, of business that
owns, operates, or provides staffing for
an 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.’’
Specifically, we proposed 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 HH services, even if the
division is run as a separate entity to the
HHA;
• Organizations that provide
telehealth, telemonitoring of HH
patients, or teleprompting services for
HHAs; and
• Organizations that provide staffing,
whether personal care aides or skilled
services staff, to HHAs for providing
care to HH patients.
(vi) 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 email to the HHCAHPS
Survey Coordination Team at
HHCAHPS@rti.org for more information.
The following is summary of the
comments we received regarding the
HHCAHPS proposal.
Comment: We received comments
that the response rate on HHCAHPS
(about 30 percent) will be low and thus
difficult to meet the minimum survey
requirement.
Response: We conducted a Survey
Mode Experiment for the HHCAHPS
with 75 HHAs nationwide with data
collection conducted between
September 21, 2009, and January 5,
2010. The overall response rate (for all
three modes of mail only, telephone
only and mixed mode of mail with
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telephone follow-up) was 45.7 percent.
As long as the HHCAHPS survey
protocols are followed and that the
random sampling is completed
correctly, the response rate of the
HHCAHPS is not of great concern. We
have not designated a minimum survey
response rate requirement for the HHAs.
Comment: Some commenters believe
that the costs to HHAs to implement the
HHCAHPS, including administrative
and vendor costs, will be very high
(estimates range from $3,500 for 300 to
500 surveys, up to $85,000).
Response: The commenters supplied a
figure of $3,500 for 300 to 500 surveys,
but did not provide the number of
surveys conducted for the $85,000
figure. Our Web site research shows that
most of the vendors are charging
between approximately $2,500 and
$5,000 for about 300 survey completes.
We recognize that vendors will charge
different amounts for the survey, and
highly recommend that HHAs ‘‘shop
around’’ for the best value for their
agency. The HHCAHPS target for the
number of survey completes is 300
regardless of agency size, thus the
$85,000 is not a realistic figure for the
cost of conducting HHCAHPS. The
approved HHCAHPS survey vendor list
is available on https://
www.homehealthcahps.org. Currently,
40 vendors are approved to conduct the
HHCAHPS survey and additional
vendors will be approved in the coming
months.
Comment: Some commenters stated
that the requirement for HHCAHPS
should begin in CY 2013 and not in CY
2012.
Response: We are not delaying the
HHCAHPS requirement for the APU to
CY 2013, as our data suggest that HHAs
began preparation for the HHCAHPS
requirement since its pendency has
been announced and discussed in prior
regulations. HHAs anticipated the
HHCAHPS requirement and this has
allowed the HHAs to prepare for the
HHCAHPS requirement. Our data, as of
mid-October 2010 show that nearly
8,000 Medicare-certified HHAs have
either applied for an exemption from
participation in HHCAHPS or registered
for credentialing to begin HHCAHPS.
However, we will not have a certain
estimate of the HHA participation rate
in the HHCAHPS dry run until after the
deadline for that data, which is 11:59
p.m., e.s.t. on January 21, 2011.
In the CY 2010 HH PPS final rule (78
FR 58078), we delayed the HHCAHPS
requirement for the APU, from CY 2011
to CY 2012. We announced in that final
rule (78 FR 58078) that HHAs would
need to conduct a dry run in third
quarter 2010 and continuously collect
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survey data beginning in the fourth
quarter 2010 and moving forward.
Although we carefully considered the
comments that we received requesting
that HHCAHPS linkage to the APU be
delayed until 2013, we believe that
HHAs have had sufficient notice of the
HHCAHPS requirements and that we do
not need to delay the linkage of
HHCAHPS to the CY 2013 APU. We
initially discussed the HHCAHPS
Survey in the May 4, 2007 proposed
rule (72 FR 25356) and in the November
3, 2008 Notice (73 FR 65357). In the CY
2010 HH PPS proposed rule (74 FR
40948), we proposed to expand the HH
quality measures reporting requirements
to include the CAHPS Home Health
Care (HHCAHPS) Survey for the CY
2011 APU. In the CY 2010 HH PPS final
rule (74 FR 58078), we stated that the
HHCAHPS would be effective with the
CY 2012 APU, instead of with the CY
2011 APU.
Comment: Some commenters
questioned the threshold of 300 surveys
which would be too difficult for small
HHAs to achieve, and too little for big
HHAs. The commenters stated that they
would not be able to make statistically
valid comparisons between small and
large HHAs with the same sample size
of 300 completed surveys per HHA.
Response: We understand concerns
about the sample size. However, an
established principle in statistics is that
a sample size in absolute numbers is
more important than a proportion of the
population surveyed. Surveying a
sample of 300 will produce the same
level of precision whether the sample is
10 percent, 1 percent, or even 0.01
percent of the total population. The
larger the sample (even if under 300),
the less variability there will be in an
agency’s ratings over time. Therefore, in
the final rule we are moving forward
with the target sample size of 300 for
HHCAHPS as proposed.
We appreciate this question clarifying
whether agencies must submit 300
completed surveys on an annual basis.
In the proposed rule and in this final
rule, we emphasized that HHAs should
target 300 completes annually which
averages about 25 completes a month.
We understand that 300 may be difficult
for some small agencies to achieve.
Therefore, smaller agencies that are
unable to reach 300 survey completes by
sampling should survey all HHCAHPS
eligible patients. We will accept less
than 300 surveys completed annually if
an agency is unable to achieve that
number. Compliance is based on
whether the agency did the survey,
following the instructed protocols and
not based on the number of patients that
responded to the survey.
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Comment: We received comments
that the HHCAHPS survey is too long.
Response: The version of the
HHCAHPS survey that was used in the
Agency for Healthcare Research and
Quality (AHRQ) field test in 2008 had
58 items, and the length of that survey
did not appear to influence the
completion of the survey. However, as
a result of intensive data analysis and
input from the stakeholders and the
Technical Expert Panel, over 20
questionnaire items were eliminated
from the field test survey. The current
34-item questionnaire (which received
National Quality Forum endorsement)
was the outcome of this development
process. We believe that the length of
the survey represents an effective
compromise and achieves the goal of
providing key quality measures of the
patient perspectives of care while at the
same time keeping the survey as short
as possible. We are not shortening the
survey in this final rule.
Comment: Some commenters believe
that the HHCAHPS survey questions are
too confusing. Other commenters stated
that the HHCAHPS survey is poorly
crafted.
Response: The developmental work
on the Home Health Care CAHPS began
in mid-2006, and the first survey was
field-tested (to validate the length and
content of the survey) in 2008 by the
AHRQ and the CAHPS grantees, and the
final survey was used in a national,
randomized mode experiment in 2009–
2010. A rigorous, scientific process was
used in the development of the survey,
including: A public call for measures;
literature reviews; focus groups with HH
patients; cognitive interviews (several
rounds in 2007) with HH patients;
extensive stakeholder input; technical
expert panel reviews, comprehensive
assessment review and subsequent
endorsement in March 2009 by the
National Quality Forum (which
represents the consensus of many health
care providers, consumer groups,
professional associations, purchasers,
federal agencies and research and
quality organizations); and public
responses to Federal Register notices.
We appreciate the commenters’
sensitivity to the HH patients in asking
about the usability of the HHCAHPS
survey. The Flesch-Kincaid reading test
showed that the HHCAHPS survey is at
less than a seventh grade level. More
importantly though, if patients are
unable to answer the survey due to
decreased capacities, a family or friend
who is not associated with the HH
services given to the patient, may assist
the patient and answer the questions on
behalf of the selected HH patient in the
HHCAHPS HHA sample.
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Comment: We received comments
that the HHAs need more education and
information about HHCAHPS before it is
a requirement.
Response: We initially discussed the
HHCAHPS Survey in the May 4, 2007
proposed rule (72 FR 25356, 25423) and
in the November 3, 2008 Notice (73 FR
65357, 65358). In the CY 2010 HH PPS
proposed rule (August 13, 2009), we
proposed to expand the HH quality
measures reporting requirements to
include the CAHPS Home Health Care
(HHCAHPS) Survey. In the CY 2010 HH
PPS final rule, we stated that the
HHCAHPS would be effective with the
CY 2012 APU. The HHCAHPS
requirements for CY 2012 have been
discussed on the CMS Home Health and
Hospice Open Door Forums from late
2009 to the present. We have posted
information regarding the HHCAHPS
requirements for CY 2012 on all CMS
sponsored Web sites for Medicare and
State Medicaid issues. We have spoken
on this topic of HHCAHPS requirements
for CY 2012 at conferences with the
National Association for Home Care and
on conference calls with the Visiting
Nurse Associations of America. We have
spoken about the HHCAHPS
requirements for CY 2012 on the CMS
State Medicaid sponsored calls. We
have maintained a very thorough and
up-to-date Web site at https://
www.homehealthcahps.org that
emphasized the importance of starting
HHCAHPS in order to meet the
requirements for CY 2012.
Comment: We received comments
that HHCAHPS does not address
communication and swallowing issues
for HH care patients.
Response: We appreciate this input
from the commenter and note that none
of the HHCAHPS questions concern
such specific issues since the number of
issues that could be addressed in a
survey of this length is limited. The
main goal of the HHCAHPS is to obtain
the patients’ perspectives of care
regardless of the specific needs of the
patients.
Comment: Some commenters question
how they will know that the approved
survey vendors are truly independent of
HHAs and telehealth companies and ask
what would happen if they
inadvertently utilized an approved
HHCAHPS vendor carrying on a
prohibited financial relationship with
another HHA.
Response: In this final rule, beginning
with the CY 2013 APU, we will be
requiring that all HHCAHPS approved
survey vendors affirm at their oversight
review, that they do not provide direct
HH care services to the patients of the
HHAs to which they are or will be
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contracting to conduct HHCAHPS on
behalf of these HHAs. If an approved
HHCAHPS survey vendor has been
discovered to have falsified its
affirmation, then that vendor will be
immediately removed from the
approved HHCAHPS survey vendor list.
For those HHAs contracting with a
vendor that is removed from the
approved HHCAHPS vendor list, CMS
will allow affected HHAs to transfer
their submitted HHCAHPS data to
another approved HHCAHPS vendor of
their choice, and arrangements will be
made should this occur in the middle of
a quarterly period when vendor changes
are not usually allowed for HHAs.
Moreover, the HHCAHPS data from
these affected HHAs will be reported on
Home Health Compare; however, they
will be designated with a footnote that
explains the circumstance.
Comment: Some commenters stated
that CMS should pay the HHAS for the
(administrative) costs associated with
HHCAHPS. We received a comment that
it will cost $1.70 more per patient to
obtain patient satisfaction input.
Response: The collection of the
patient’s perspectives of care quality
data for similar CAHPS surveys, such as
the Hospital CAHPS survey, follow the
same model wherein the health care
providers pay the approved survey
vendors for the data collection costs and
we pay for the training, technical
assistance, oversight of vendors and
data analysis costs. HHAs are strongly
encouraged to report their respective
HHCAHPS costs on their cost reports
but should note that these costs are not
reimbursable under the HH PPS. It is
advised that HHAs ‘‘shop around’’ for
the best cost value for them before
contracting with an approved vendor to
conduct HHCAHPS on their behalf.
Comment: Some commenters believe
that the HHCAHPS is not consistent
with Hospital CAHPS (HCAHPS).
Response: We believe that the two
surveys do not have to be consistent as
the populations are different for
Hospital and Home Health CAHPS. The
differences in the types of questions
reflect the differences in the nature of
the services provided. However, both
CAHPS surveys followed the same
processes for the development of the
survey and data collection protocols.
Comment: We received comments
that about 70 percent of HHAs have not
responded to the requirement for
HHCAHPS thus far, since about July
2010, only 2,109 of the 10,500 HHAs
have signed up, and another 1,114 have
applied for exemptions from HHCAHPS.
These figures show a poor rate of
participation for HHCAHPS thus far.
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Response: The HHAs’ response to
participating in HHCAHPS has changed
since July 2010. Recent data show us
that very nearly 8,000 of Medicarecertified HHAs have begun to engage in
HHCAHPS, by either beginning the
vendor approval process for the survey
on https://www.homehealthcahps.org,
or by applying for an exemption from
the survey on https://
www.homehealthcahps.org. We
anticipate that this participation rate
will increase, especially in the next few
months. We are carefully watching the
participation rate for HHCAHPS, and we
will continue to inform the public about
HHCAHPS through the Home Health
and Hospice Open Door Forums, Web
sites, and other means of
communication.
Comment: One commenter stated
concerns that while there are
unscrupulous HHAS, most of the small
HHAs have to comply with more
requirements and face difficulty with
remaining operational.
Response: We appreciate the
commenter’s concerns with the complex
HHA system, which may allow
unscrupulous providers to take
advantage of senior citizens needing
good HH services. We are aware that
newer requirements, such as HHCAHPS,
may be perceived as an additional cost
and responsibility for HHAs. However,
at the same time, we believe that
HHCAHPS will benefit both seniors and
other users of HH services because the
survey will provide transparency and
access to more information about the
quality of HH care. In addition, HHAs
will benefit with the information
gleaned from HHCAHPS to utilize for
their internal quality improvement
purposes that benefit their agencies as
businesses and providers of HH
services.
Comment: We received a comment
asking why interactive voice recognition
(IVR) technology or internet-based
technology would be excluded as a
survey mode.
Response: We appreciate the
commenter’s knowledge about IVR
technology and the possible inclusion of
this technology as an additional survey
mode for HHCAHPS. Through the
period of developing and testing the
HHCAHPS survey, the mail only,
telephone only, and mail with
telephone follow-up modes were found
to be the most suitable for the patient
population receiving HH care services.
However, we are certainly open to
continue testing additional survey
modes for HHCAHPS, especially with
the possibility of internet methodologies
in the future.
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Comment: We received a comment on
how an approved survey vendor can
simultaneously be an ‘‘independent’’
HHCAHPS surveyor and provide
consultative services to the same HHAs
on improving their operations. Such a
situation is a classic conflict of interest.
Response: We appreciate this
commenter’s concerns about the
independence that HH CAHPS vendors
should maintain from the HHAs that are
their clients. However, we believe that
one of the goals of the HH care CAHPS
survey is that HHAs can identify
opportunities for improvement and
ways to improve care. As long as the
vendor does not directly provide care to
patients, the vendor can independently
provide guidance regarding methods to
improve care provided by the HHA.
Comment: One commenter requested
that we reevaluate and eliminate
proposed criteria that would exclude
potential vendors, as the criteria
overstep CMS’ authority to restrict
legitimate business.
Response: We proposed these vendor
requirements because we need to ensure
that fully qualified organizations would
be capable of undertaking the
HHCAHPS surveys. Based on the vast
input from stakeholders and the public,
we proposed these requirements to
ensure that an independent party will
be best able to solicit unbiased, uncoerced responses to HHCAHPS survey.
Comment: One commenter stated that
HHCAHPS is a proposed change that
will be damaging to the HH industry
and to the care and services provided to
Medicare beneficiaries.
Response: We believe that HHCAHPS
will benefit both seniors and other users
of HH services because they will have
access to more information about the
quality of HH care. In addition, HHAs
will benefit with the information
gleaned from HHCAHPS to use for their
internal quality improvement purposes
and benefit their agencies as businesses
and providers of HH services.
Comment: One commenter requested
that CMS extend the deadline for
agencies to apply for the HHCAHPS
survey exemption beyond the original
June 16, 2010 deadline.
Response: We will be extending the
deadline for agencies to apply for
HHCAHPS survey exemption for the CY
2012 APU to 11:59 p.m., e.s.t. on
January 21, 2011. It is noted that the
application for exemption from
participation in HHCAHPS has to be
submitted every year.
Comment: One commenter asked if
CMS will require additional consent/
authorizations to allow protected health
information (PHI) patients to be
included in HHCAHPS, since these PHI
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70409
patients are now in the excluded
categories for HHCAHPS. These
additional consent/authorizations are
required by New York State law.
Response: These PHI patients are
ineligible to be included in HHCAHPS
by New York State Law. We are
prohibited by law to include PHI
patients in the HHCAHPS survey under
any circumstances. In the HHCAHPS
Protocols and Guidelines manual which
can be found at https://
homehealthcahps.org, it states that
patients who have a condition or illness
for which the state in which the patient
resides has regulations or laws
restricting the release of patient
information for patients with that
condition (for example, patients with
HIV/AIDS), that these patients are not
eligible to be included in the HHCAHPS
sampling procedures.
(vii) Provisions of the Final Rule
As a result of the comments, we will
be extending the deadline for HHAs to
apply for HHCAHPS survey exemption
for the CY 2012 APU to 11:59 p.m., e.s.t.
on January 21, 2011. Therefore, the
deadline for the submission of the dry
run data (collected in the third quarter
of 2010) for the CY 2012 APU is January
21, 2011, and the deadline to apply for
HHCAHPS survey exemption for the CY
2012 APU is also January 21, 2011. It is
noted that the application for exemption
from participation in HHCAHPS has to
be submitted every year.
In this final rule, beginning with the
CY 2013 APU, we will be requiring that
all HHCAHPS approved survey vendors
affirm at their oversight review, that
they do not provide direct HH care
services to the patients of the HHAs to
which they are or will be contracting to
conduct HHCAHPS on behalf of these
HHAs. If an approved HHCAHPS survey
vendor is found to have falsified its
affirmation, then that vendor will be
immediately removed from the
approved HHCAHPS survey vendor list.
For those HHAs contracting with an
HHCAHPS vendor that is removed from
the approved HHCAHPS vendor list, we
will allow affected HHAs to transfer
their submitted HHCAHPS data to
another approved HHCAHPS vendor of
their choice and arrangements will be
made should this occur in the middle of
a quarterly period when vendor changes
are not usually allowed for HHAs.
Moreover, the HHCAHPS data from
these affected HHAs will be reported on
Home Health Compare; however, they
will be designated with a footnote that
explains the circumstance.
There are no other changes noted
from the CY 2011 HH PPS proposed
rule.
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3. Home Health Wage Index
Sections 1895(b)(4)(A)(ii) and (b)(4)(C)
of the Act require the Secretary to
provide appropriate adjustments to the
proportion of the payment amount
under the HH PPS to account for area
wage differences, using adjustment
factors that reflect the relative level of
wages and wage-related costs applicable
to the furnishing of HH services. 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). Previously, we determined
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 an 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 were no
hospitals and, thus, no hospital wage
data on which to base the calculation of
the HH 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
HH wage index. For rural areas that do
not have IPPS hospitals, we use the
average wage index from all contiguous
CBSAs as a reasonable proxy. This
methodology is used to calculate the
wage index for rural Massachusetts.
However, we could not apply this
methodology to rural Puerto Rico due to
the distinct economic circumstances
that exist there, but instead continue
using the most recent wage index
previously available for that area (from
CY 2005). For urban areas without IPPS
hospitals, we use the average wage
index of all urban areas within the State
as a reasonable proxy for the wage index
for that CBSA. The only urban area
without IPPS hospital wage data is
Hinesville-Fort Stewart, Georgia (CBSA
25980).
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On December 1, 2009, OMB issued
Bulletin No. 10–02 located at https://
www.whitehouse.gov/omb/assets/
bulletins/b10-02.pdf.
This bulletin highlights three
geographic areas whose principal city
has changed, and therefore led to the
following CBSA names all and within a
0.05 percentage point range changes and
new CBSA numbers.
• Bradenton-Sarasota-Venice, FL
(CBSA 14600) is replaced by North PortBradenton-Sarasota, FL (CBSA 35840).
• Fort Walton Beach-CrestviewDestin, 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 SteubenvilleWeirton, OH-WV (CBSA 44600).
The CBSAs and their associated wage
index values are shown in Addendum B
of this final rule. The wage index values
for rural areas are shown in Addendum
A of this final rule.
The following is a summary of the
comments we received regarding the HH
wage index proposal.
Comment: A commenter stated that
the budget neutral nature of the
methodology means that increases in
the wage index in one area of the
country necessarily result in decreases
in another.
Response: By nature, the construct of
the hospital wage index, in the
aggregate, is to average at 1.0. Hence, the
index is constructed to be budget
neutral in the sense that for areas where
wage index values increase, those
increases are offset by decreases in other
areas. The hospital wage index is based
on hospital cost data and hospital
utilization, and thus in the aggregate,
when applied to HH utilization for the
purposes of impacts, the average wage
index value may not result to be exactly
1.0. For instance, as explained in the
impact analysis section for this final
rule, the new wage index will result in
an estimated increase of $20 million in
aggregate payments to HHAs in CY
2011.
Comment: A commenter stated that
dropping critical access hospitals
(CAHs) from the calculation of the wage
index affects HHAs. As CAHs are
located in rural areas, the absence of
CAH wage data further compromises the
accuracy, and therefore the
appropriateness, of using a hospital
wage index to determine the labor costs
of HHAs located in rural areas.
Response: While we understand the
commenter’s concern, we are not able to
address the comment, because the
methodology regarding the pre-floor,
pre-reclassified hospital wage index
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calculation (which we continue to
believe results in an appropriate
adjustment to the labor portion of the
costs as required by statute), is outside
of the scope of this final rule.
Comment: A commenter stated that,
pending development of an industry
specific wage index, CMS should
investigate the impact of a population
density adjustment. A population
density adjustment would result in a
more accurate wage adjustment that
recognizes the productivity lost in time
spent in traveling to provide services in
less densely populated areas. CMS
could simply add a population density
factor by zip code during calculation of
the labor portion of the payment to
account for increased costs of providing
services in less densely populated areas.
In addition, this adjustment would
reduce excess reimbursement for
services provided in densely populated
urban and congregate living facilities.
Response: We appreciate the
commenter’s comment, but we do not
have evidence that a population density
adjustment is an appropriate adjustment
to a wage index. Section 3131(d) of the
Affordable Care Act requires the
Secretary to conduct a study on HHA
costs involved with providing ongoing
access to care to low-income Medicare
beneficiaries or beneficiaries in
medically underserved areas, and in
treating beneficiaries with varying levels
of severity of illness. Because medically
underserved areas may be associated
with population density, the purview of
the above mentioned study may
possibly include feasibility of such an
adjustment as part of that research.
However, we note that in setting up the
original HH PPS rates in 2000, we were
not able to find any cost differences
between rural and urban HHAs. While
rural agencies cite the added cost of
long distance travel to treat their
patients, urban/non-rural agencies also
cite added costs such as needed security
measures and the volume of traffic that
they must absorb. We will consider this
suggestion in future research activities.
Comment: A commenter stated that
the current wage index does not
measure local wages accurately since
the wages vary widely in some areas.
Response: The wages are measured at
the local level as defined by CBSAs.
HHAs are reimbursed based on the site
of service of the beneficiary, using the
wage index value for that area to adjust
payment for geographical differences.
Comment: A commenter stated
concerns regarding the use of the prefloor, pre-reclassified hospital wage
index to determine geographically
relevant wages for HH workers. The
commenter stated that there is a lack of
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parity between different health care
provider types, each of which is subject
to some form of a hospital wage index,
but experiences distinct actual values in
their specific geographic area. Hospitals
are given the opportunity to reclassify as
a means of being considered to be in a
geographical area with a higher wage
index. HHAs are not given this option.
Using the pre-floor, pre-reclassified
wage index continues to put home care
at a distinct disadvantage in attracting
and retaining employees. Existing law
permits CMS a nearly unlimited degree
of flexibility to utilize a wage index that
recognizes the geographic differences in
labor costs in the provision of HH
services across the country. Section
1895(b)(4)(C) of the Act mandates the
establishment of area wage index
adjustment factors, provides the
Secretary discretion to determine which
factors to consider, and permits the
Secretary to utilize the same wage index
adjustment factors that are utilized in
composing the hospital wage index. The
inherent inequity of HHAs competing
for labor in the same service area as a
reclassified hospital is similarly overdue
for redress. CMS has the statutory
authority to select the wage index
method to be applied to HHAs and
should move the wage index toward
some level of comparability with that
enjoyed by hospitals.
Response: The regulations that govern
the HH PPS currently do not provide a
mechanism for allowing providers to
seek geographic reclassification. As we
have explained in the past (most
recently, in the CY 2010 HH PPS final
rule (74 FR 58105)), the rural floor and
geographic reclassification in the IPPS
are statutorily authorized and are only
applicable to hospital payments. The
rural floor provision is provided at
section 4410 of the Balanced Budget Act
of 1997 (Pub. L. 105–33) (BBA) and is
exclusive to hospitals. The
reclassification provision provided at
section 1886(d)(10) of the Act is also
specific to hospitals.
Comment: In the current environment
of deep, across-the-board cuts, the
additional impact of inequitable,
unpredictable, negative swings in wage
index cannot be ignored any longer.
Such swings are exacerbated by the
current economic climate. The HH wage
index is too volatile from one year to the
next. CMS should develop a process
that would alert HHAs to prospective
swings in the hospital wage index prior
to hospital wage data finalization,
allowing agencies to seek intervention
to eliminate or correct for missing or
potentially spurious hospital cost report
data on labor costs. The extra time
would also allow agencies an
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opportunity to begin planning for
changes needed to accommodate an
otherwise unexpected wage index
swing. At a minimum, the commenters
urged CMS to put a ceiling and floor on
year-to-year changes in the wage index
to mitigate sudden payment changes.
Another commenter asked CMS to
consider applying the hospital wage
index to all healthcare providers in a
community. The commenter’s opinion
is that homecare nurses require more
skills and certifications than hospital
nurses and home care organizations
should be able to reimburse them fairly.
Response: We have consistently used
the pre-floor, pre-reclassified hospital
wage index to adjust the labor portion
of the HH PPS rates. The commenter is
referring to rural floor and geographic
reclassification provisions in the IPPS,
which are only applicable to hospital
payments. The rural floor provision is
provided at section 4410 of the BBA and
is specific to hospitals. The
reclassification provision provided at
section 1886(d)(10) of the Act is also
specific to hospitals. As such, we
continue to believe that 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.
Comment: CMS should develop and
conduct a voluntary pilot test on a HH
specific wage index based on nonhospital, Bureau of Labor Statistics
(BLS) data calculated on a county level,
rather than on the Core Base Statistical
Area (CBSA) level. Several commenters
stated that CMS’ decision five years ago
to switch from the Metropolitan
Statistical Areas (MSAs) to the CoreBased Statistical Areas (CBSAs) for the
wage index calculation has had serious
financial ramifications for HHAs. The
commenters recommend that CMS
pursue a total reform of the HH wage
index.
Response: As we have stated in
previous rules, previous proposals to
develop a HH-specific wage index were
not well received by commenters or the
industry. Generally, the volatility of the
HH wage data and the resources needed
to audit and verify that data make
ensuring that such a wage index most
accurately reflects the wages and wagerelated costs applicable to the
furnishing of HH services difficult. As
such, we are not adopting a HH-specific
wage index at this time. We believe that
more importantly, a HH-specific wage
index should be reflective of the wages
and salaries paid in a specific area, be
based upon a stable data source, and
significantly improve our ability to
determine HH payments without being
overly burdensome.
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In its June 2007 report titled, ‘‘Report
to Congress: Promoting Greater
Efficiency in Medicare’’, MedPAC
recommended that the Congress ‘‘repeal
the existing hospital wage index statute,
including reclassification and
exceptions, and give the Secretary
authority to establish new wage index
systems.’’ As such, we will continue to
review and consider MedPAC’s
recommendations on a refined
alternative wage index methodology for
the HH PPS in the future. We believe
that the current payment adjustment
based on the CBSA areas is the best
available method of compensating for
differences in labor markets.
Comment: A commenter encourages
CMS to analyze HH care providers both
by geographic location (urban vs. rural)
and by business status (for-profit vs.
not-for-profit) such that Medicare
payment policy can be modified to
reward quality and efficiency and
reduce incentives to ‘‘pad’’
documentation and increase revenue.
Response: We will be looking to
improve the accuracy of payment to
HHAs in the future, through a number
of efforts. Section 3131(a) of the
Affordable Care Act requires the
Secretary to rebase HH payments,
beginning in 2014. Factors that will be
analyzed and considered include
changes in the number of visits in an
episode, the mix of services in an
episode, the level of intensity of services
in an episode, the average cost of
providing care per episode, and other
factors that the Secretary considers to be
relevant. In conducting the analysis for
rebasing, we may consider differences
between hospital-based and
freestanding agencies, between for-profit
and nonprofit agencies, and between the
resource costs of urban and rural
agencies. Additionally, section 3131(d)
of the Affordable Care Act requires the
Secretary to study and report on the
development of HH payment revisions
that would ensure access to care and
payment for severity of illness. The
study is to be on HHA costs involved
with providing ongoing access to care to
low-income Medicare beneficiaries or
beneficiaries in medically underserved
areas, and in treating beneficiaries with
varying levels of severity of illness. As
part of this study, we are required to
consult with appropriate stakeholders,
such as groups representing HHAs and
groups representing Medicare
beneficiaries. At the conclusion of this
study, we must submit a Report to the
Congress by March 1, 2014. Based on
the findings of this study, the Secretary
may provide for a demonstration project
to test whether making payment
adjustments for HH services under the
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Medicare program would substantially
improve access to care for patients with
high severity levels of illness or for lowincome or underserved Medicare
beneficiaries.
4. CY 2011 Annual Payment Update
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a. National Standardized 60-Day
Episode Rate
The Medicare HH PPS has been in
effect since October 1, 2000. As set forth
in the July 3, 2000 final rule (65 FR
41128), the base unit of payment under
the Medicare HH PPS is a national
standardized 60-day episode rate. As set
forth in § 484.220, we adjust the
national standardized 60-day episode
rate by a case-mix relative weight and a
wage index value based on the site of
service for the beneficiary.
In the CY 2008 HH PPS final rule with
comment period, we refined the casemix methodology and also rebased and
revised the HH market basket. To
provide appropriate adjustments to the
proportion of the payment amount
under the HH PPS to account for area
wage difference, we apply the
appropriate wage index value to the
labor portion of the HH PPS rates. 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 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. Following are the
steps we take to compute the case-mix
and wage adjusted 60-day episode rate:
(1) Multiply the national 60-day
episode rate by the patient’s applicable
case-mix weight.
(2) Divide the case-mix adjusted
amount into a labor (77.082 percent)
and a non-labor portion (22.918
percent).
(3) Multiply the labor portion by the
applicable wage index based on the site
of service of the beneficiary.
(4) Add the wage-adjusted portion to
the non-labor portion, yielding the casemix and wage adjusted 60-day episode
rate, subject to any additional applicable
adjustments.
In accordance with section
1895(b)(3)(B) of the Act, this document
constitutes the annual update of the HH
PPS rates. The HH PPS regulations at
§ 484.225 set forth the specific annual
percentage update methodology. In
accordance with § 484.225(i), for a HHA
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that does not submit HH 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 HH 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 considered in
computing the prospective payment
amount for a subsequent calendar year.
For CY 2011, we proposed 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 update the national per-visit
rates by discipline annually by the
applicable HH market basket
percentage. We adjust the national pervisit rate by the appropriate wage index
based on the site of service for the
beneficiary, as set forth in § 484.230. We
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
also proposed to update the LUPA addon payment amount and the NRS
conversion factor by the applicable HH
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 § 484.205(b)(1) and
§ 484.205(b)(2). We may base the initial
percentage payment on the submission
of a request for anticipated payment
(RAP) and the final percentage payment
on the submission of the claim for the
episode, as discussed in § 409.43. The
claim for the episode that the HHA
submits for the final percentage
payment determines the total payment
amount for the episode and whether we
make an applicable adjustment to the
60-day case-mix and wage-adjusted
episode payment. The end date of the
60-day episode as reported on the claim
determines which calendar year rates
Medicare would use to pay the claim.
We may also adjust the 60-day casemix and wage-adjusted episode
payment based on the information
submitted on the claim to reflect the
following:
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• A low utilization payment provided
on a per-visit basis as set forth in
§ 484.205(c) and § 484.230.
• A partial episode payment
adjustment as set forth in § 484.205(d)
and § 484.235.
• An outlier payment as set forth in
§ 484.205(e) and § 484.240.
b. Updated CY 2011 National
Standardized 60-Day Episode Payment
Rate
In calculating the annual update for
the CY 2011 national standardized 60day episode payment rates, we first look
at the CY 2010 rates as a starting point.
The CY 2010 national standardized 60day episode payment rate is $2,312.94.
As previously discussed in section
II.D. of this final rule (‘‘Outlier Policy’’),
in our policy of targeting outlier
payments to be approximately 2.5
percent of total HH PPS payments in CY
2011, we proposed 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 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 the previous
year for CY 2010 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
CY 2011 HH market basket update of
1.1 percent.
As previously discussed in section
II.A. of this final rule (‘‘Case-Mix
Measurement Analysis’’), 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 reduce rates by 3.79
percent in CY 2011, resulting in an
updated CY 2011 national standardized
60-day episode payment rate of
$2,192.07. The 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 updated CY 2011 national
standardized 60-day episode payment
rate for an HHA that does not submit the
required quality data (that is, HH market
basket update of 1.1 percent is reduced
by 2 percentage points) is shown in
Table 5.
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70413
TABLE 4—NATIONAL 60-DAY EPISODE PAYMENT AMOUNT UPDATED BY THE HOME HEALTH MARKET BASKET UPDATE FOR
CY 2011, BEFORE CASE-MIX ADJUSTMENT AND WAGE ADJUSTMENT BASED ON THE SITE OF SERVICE FOR THE
BENEFICIARY
CY 2010 National
standardized 60-day
episode payment rate
Adjusted to return the
outlier funds that paid
for the 2.5 percent
target for outlier payments in CY 2010
Reduced by 5 percent
due to the outlier
adjustment mandated
by The Affordable
Care Act
Multiply by the home
health market basket
update of 1.1 percent
Reduce by 3.79
percent for nominal
change in case-mix
CY 2011 National
standardized 60-day
episode payment rate
$2,312.94
÷ 0.975
× 0.95
× 1.011
× 0.9621
$2,192.07
TABLE 5—FOR HHAS THAT DO NOT SUBMIT THE QUALITY DATA—NATIONAL 60-DAY EPISODE PAYMENT AMOUNT UPDATED BY THE HOME HEALTH MARKET BASKET UPDATE FOR CY 2011, BEFORE CASE-MIX ADJUSTMENT AND WAGE
ADJUSTMENT BASED ON THE SITE OF SERVICE FOR THE BENEFICIARY
CY 2010 National
standardized 60-day
episode payment rate
Adjusted to return the
outlier funds that paid
for the 2.5 percent
target for outlier payments in CY 2010
Reduced by 5 percent
due to the outlier
adjustment mandated
by the Affordable
Care Act
Multiply by the home
health market basket
update of 1.1 percent
minus 2 percentage
points (¥0.9 percent)
Reduce by 3.79
percent for nominal
change in case-mix
CY 2011 National
standardized 60-day
episode payment rate
$2,312.94
÷ 0.975
× 0.95
× 0.991
× 0.9621
$2,148.71
c. National Per-Visit Rates Used To Pay
LUPAs and Compute Imputed Costs
Used in Outlier Calculations
In calculating the CY 2011 national
per-visit rates used to calculate
payments for LUPA episodes and to
compute the imputed costs in outlier
calculations, the CY 2010 national pervisit rates for each discipline are
adjusted for the 2.5 percent set aside
during CY 2011 for outlier payments.
Then these national per-visit rates are
reduced 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, the national
per-visit rates are updated by the CY
2011 HH market basket update of 1.1
percent. National per-visit rates are not
subject to the 3.79 percent reduction
related to the nominal increase in case-
mix. The CY 2011 national per-visit
rates per discipline are shown in Table
6. The six HH disciplines are as follows:
• Home Health Aide (HH aide);
• Medical Social Services (MSS);
• Occupational Therapy (OT);
• Physical Therapy (PT);
• Skilled Nursing (SN); and
• Speech Language Pathology
Therapy (SLP).
TABLE 6—NATIONAL PER-VISIT AMOUNTS FOR LUPAS (NOT INCLUDING THE LUPA ADD-ON AMOUNT FOR A BENEFICIARY’S ONLY EPISODE OR THE INITIAL EPISODE IN A SEQUENCE OF ADJACENT EPISODES) AND OUTLIER CALCULATIONS UPDATED BY THE CY 2011 HOME HEALTH MARKET BASKET UPDATE, BEFORE WAGE INDEX ADJUSTMENT
Home health discipline type
CY 2010
Per-visit
amounts per
60-day
episode
For HHAs that DO submit
the required
quality data
Adjusted to
return the
outlier funds
that paid for
the 2.5
percent
target for
outlier payments in CY
2010
Reduced by
5 percent
due to the
outlier adjustment
mandated
by The
Affordable
Care Act
÷
÷
÷
÷
÷
÷
×
×
×
×
×
×
emcdonald on DSK2BSOYB1PROD with RULES2
$51.18
181.16
124.40
123.57
113.01
134.27
d. LUPA Add-on Payment Amount
Update
payment before adjusting for area wage
differences.
The following is a summary of the
comments we received regarding the
LUPA add-on Payment.
Comment: Several commenters stated
that at a time when costs are increasing,
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0.95
0.95
0.95
0.95
0.95
0.95
×
×
×
×
×
×
HH Aide ....................................................
MSS .........................................................
OT ............................................................
PT .............................................................
SN ............................................................
SLP ..........................................................
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
0.975
0.975
0.975
0.975
0.975
0.975
Multiply by
the home
health
market
basket update of 1.1
percent
Sfmt 4700
CY 2011
per-visit
payment
amount f
For HHAs
that DO
submit the
required
quality data
1.011
1.011
1.011
1.011
1.011
1.011
$50.42
178.46
122.54
121.73
111.32
132.27
For HHAs that DO NOT
submit the required
quality data
Multiply by
the home
health market basket
update of
1.1 percent
minus 2
percentage
points
(¥0.9 percent)
×
×
×
×
×
×
0.991
0.991
0.991
0.991
0.991
0.991
CY 2011
per-visit
payment
amount for
HHAs that
DO NOT
submit the
required
quality data
$49.42
174.93
120.12
119.32
109.12
129.65
the LUPA ‘‘add-on reduction’’ will make
it more difficult for agencies to deal
with the additional mandates that were
added to the start of care visit. This is
the first time a reduction is proposed for
the LUPA add-on. Costs continue to
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escalate, but CMS continues to expect
more while decreasing payments.
Response: We assume that the
commenter is referring to either the 2.5
percent reduction to the HH PPS
payment amounts due to the outlier
policy legislated by section 3131(b) of
the Affordable Care Act or the 1
percentage point reduction for CY 2011,
2012, and 2013 and the productivity
adjustment for CY 2015 and subsequent
years to the HH market basket update
legislated by section 3401(e) of the
Affordable Care Act; or both. As both
reductions are legislated by the
Affordable Care Act, we have no
regulatory authority to do otherwise.
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 CY
2011 HH market basket update
percentage of 1.1 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, the add-on to the LUPA
payment to HHAs that submit the
required quality data will be updated by
the HH market basket update of 1.1
percent. The CY 2011 LUPA add-on
payment amount is shown in Table 7.
The add-on to the LUPA payment to
HHAs that do not submit the required
quality data will be updated by the HH
market basket update (1.1 percent)
minus two percentage points.
TABLE 7—CY 2011 LUPA ADD-ON AMOUNTS
CY 2010 LUPA
Add-On Amount
Adjusted to return
the outlier funds,
that paid for the
original 5 percent
target for outliers
$94.72
For HHAs that DO submit the required
quality data
Adjusted to return
the outlier funds
that paid for the
2.5 percent target
for outlier payments in CY 2010
Reduced by 5 percent due to the
outlier adjustment
mandated by the
Affordable Care
Act
Multiply by the
home health market basket update
of 1.1 percent
CY 2011 LUPA
Add-On Amount
for HHAs that DO
submit required
quality data
Multiply by the
home health market basket update
of 1.1 percent
minus 2 percentage points (¥0.9
percent)
CY 2011 LUPA
Add-On Amount
for HHAs that DO
NOT submit required quality data
÷ 0.975
× 0.95
× 1.011
$93.31
× 0.991
$91.46
emcdonald on DSK2BSOYB1PROD with RULES2
e. Nonroutine Medical Supply
Conversion Factor Update
The following is summary of the
comments we received regarding the
Nonroutine Medical Supplies (NRS).
Comment: A commenter stated that
the calculation for the nonroutine
medical supply conversion factor
includes a reduction of 3.79 percent for
the change in nominal case-mix weight.
The commenter does not believe this
reduction should be applied to the
calculation of the NRS, as the NRS
payment amount is not directly affected
by changes in case-mix weight.
When CMS developed the
refinements to the PPS payment rates
effective for calendar year 2008,
significant changes were made to the
methodology for reimbursing of
nonroutine medical supplies. The
analysis performed by CMS was
designed to ‘‘better match NRS
payments with NRS costs.’’ ‘‘The
proposed and final regression models
were developed after additional
variables from OASIS items and
targeting certain conditions expected to
be predictors of NRS use based on
clinical considerations. To account for
paying of NRS through the
implementation of a 6-severity group
methodology, and to maintain budget
neutrality, we reduce the national
standardized 60-day episode payment
rate (72 FR 49851 through 49852).
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The standardized payment amount
was adjusted to remove the cost
attributed to NRS or $45.87 (72 FR
49865). Therefore, due to this change in
methodology the NRS amount paid to
HHAs is no longer subject to variation
based upon the case-mix weight of the
episode. Indeed, an episode with a casemix of 0.5827 can receive the same NRS
payment amount as an episode with a
case-mix of 3.4872. Therefore, the casemix adjustment as proposed should not
be applied to the NRS payment
amounts.
Response: We appreciate the
commenter’s perspective and input.
Because our case-mix adjustment
parameter comes from modeling the
episode case-mix weights, not the NRS
case-mix levels, we will defer the
application of the 3.79 percent case-mix
reduction to the NRS payment amounts
for CY 2011, pending the results of an
independent review of our case-mix and
NRS models. Therefore, the NRS
payment calculation will not be
decreased by 3.79 percent for CY 2011.
Comment: A commenter stated that
reimbursement for nonroutine supplies
is not adequate to cover current costs for
these supplies. Vendors of nonroutine
supplies continue to increase costs for
agencies.
Response: In our CY 2008 final rule,
we implemented the now existing 6severity group methodology for payment
of NRS. As part of that implementation,
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we built intelligence into the HIPPS
code so that we would know when
supplies are being provided and when
they are not, at all NRS severity levels.
Since the expiration of a 6-month grace
period, HHAs have been required to
denote, through the HIPPS code they
submit on the claim, whether supplies
were actually provided to the
beneficiary during that HH episode of
care. As such, we will soon have the
improved data on NRS, providing us
with a much better capability to analyze
and evaluate payment to HHAs for NRS
in the future.
Payments for nonroutine 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(b) of the Affordable Care Act.
Next, we update by the CY 2011 market
basket update of 1.1 percent. As
mentioned above in our summary of
comments related to the NRS, we will
not apply the 3.79 percent case-mix
reduction to the NRS payment amounts
for CY 2011. The final updated CY 2011
NRS conversion factor for CY 2011 in
Table 8A. For CY 2011, the NRS
conversion factor is $52.54.
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70415
TABLE 8A—CY 2011 NRS CONVERSION FACTOR FOR HHAS THAT DO SUBMIT THE REQUIRED QUALITY DATA
CY 2010 NRS conversion
factor
Adjusted to return the
outlier funds that paid for
the 2.5 percent target for
outlier payments in CY
2010
Reduced by 5 percent due
to the outlier adjustment
mandated by The
Affordable Care Act
Multiply by the home
health market basket
update of 1.1 percent
CY 2011 NRS conversion
factor for HHAs that do
submit the required quality
data
$53.34
÷ 0.975
× 0.95
× 1.011
$52.54
Using the NRS conversion factor
($52.54) for CY 2011, the payment
amounts for the various severity levels
are shown in Table 8B.
TABLE 8B—RELATIVE WEIGHTS FOR THE 6-SEVERITY NRS SYSTEM
Points
(scoring)
Severity level
1
2
3
4
5
6
............................................................................
............................................................................
............................................................................
............................................................................
............................................................................
............................................................................
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
Relative weight
0 ............................................................................
1 to 14 ..................................................................
15 to 27 ................................................................
28 to 48 ................................................................
49 to 98 ................................................................
99+ ........................................................................
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 CY 2011
NRS payment
amount
0.2698
0.9742
2.6712
3.9686
6.1198
10.5254
$14.18
51.18
140.34
208.51
321.53
553.00
HH market basket update percentage of
1.1 percent minus 2 percentage points.
The CY 2011 NRS conversion factor for
HHAs that do not submit quality data is
shown in Table 9A.
TABLE 9A—CY 2011 NRS CONVERSION FACTOR FOR HHAS THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA
CY 2010 NRS conversion
factor
Adjusted to return the
outlier funds that paid for
the 2.5 percent target for
outlier payments in CY
2010
Reduced by 5 percent due
to the outlier adjustment
mandated by The
Affordable Care Act
Multiply by the proposed
home health market basket update of 1.1 percent
minus 2 percentage points
(¥0.9 percent)
CY 2011 NRS conversion
factor for HHAs that do not
submit the required quality
data
$53.34
÷ 0.975
× 0.95
× 0.991
$51.50
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.
TABLE 9B—RELATIVE WEIGHTS FOR THE 6-SEVERITY NRS SYSTEM FOR HHAS THAT DO NOT SUBMIT QUALITY DATA
Points
(scoring)
Severity level
1
2
3
4
5
6
..........................................................................
..........................................................................
..........................................................................
..........................................................................
..........................................................................
..........................................................................
emcdonald on DSK2BSOYB1PROD with RULES2
5. Rural Add-On
The following is summary of the
comments we received regarding the
rural add-on policy.
Comment: Several commenters stated
support for the 3 percent rural add-on
to the national standardized 60-day
episode rate, national per-visit rates,
LUPA add-on amount, and nonroutine
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Relative weight
0 .........................................................................
1 to 14 ................................................................
15 to 27 ..............................................................
28 to 48 ..............................................................
49 to 98 ..............................................................
99+ .....................................................................
medical supplies (NRS) conversion
factor for HH services provided in rural
areas through December 15, 2015. They
state that this rural add-on reflects the
higher costs of rural agencies.
Response: The rural add-on is
mandated by section 3131(c) of the
Affordable Care Act. Section 3131(c) of
the Affordable Care Act amended
section 421(a) of the MMA, which was
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0.2698
0.9742
2.6712
3.9686
6.1198
10.5254
NRS payment
amount
$13.89
50.17
137.57
204.38
315.17
542.06
amended by section 5201(b) of the DRA.
Thus 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 HH
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
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waives budget neutrality related to this
provision, as the statute specifically
states that the Secretary shall not reduce
the standard prospective payment
amount (or amounts) under section 1895
of the Act applicable to HH 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 HH 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 for these payment
rates.
TABLE 10—CY 2011 PAYMENT AMOUNTS FOR 60-DAY EPISODES FOR SERVICES PROVIDED IN A RURAL AREA BEFORE
CASE-MIX AND WAGE INDEX ADJUSTMENT
For HHAs that DO submit quality data
For HHAs that DO NOT submit quality data
CY 2011 national
standardized 60-day
episode payment rate
Multiply by the 3 percent rural add-on
Total CY 2011
national standardized
60-day episode
payment rate
CY 2011 national
standardized 60-day
episode payment rate
Multiply by the 3 percent rural add-on
Total CY 2011 national standardized
60-day episode
payment rate
$2,192.07
× 1.03
$2,257.83
$2,148.71
× 1.03
$2,213.17
TABLE 11—PER-VISIT AMOUNTS FOR SERVICES PROVIDED IN A RURAL AREA, BEFORE WAGE INDEX ADJUSTMENT
For HHAs that DO submit quality data
CY 2011 pervisit rate for
HHAs that
DO submit
quality data
Home health discipline type
HH Aide ................................................................
MSS .....................................................................
OT ........................................................................
PT .........................................................................
SN ........................................................................
SLP ......................................................................
Total CY
2011 per-visit
rate for rural
areas
×
×
×
×
×
×
CY 2011 pervisit rate for
HHAs that
DO NOT
submit quality
data
$51.93
183.81
126.22
125.38
114.66
136.24
Multiply by
the 3 percent
rural add-on
$50.42
178.46
122.54
121.73
111.32
132.27
For HHAs that DO NOT submit quality data
$49.42
174.93
120.12
119.32
109.12
129.65
1.03
1.03
1.03
1.03
1.03
1.03
Total CY
2011 per-visit
rate for rural
areas
Multiply by
the 3 percent
rural add-on
×
×
×
×
×
×
1.03
1.03
1.03
1.03
1.03
1.03
$50.90
180.18
123.72
122.90
112.39
133.54
TABLE 12—TOTAL CY 2011 LUPA ADD-ON AMOUNTS FOR SERVICES PROVIDED IN RURAL AREAS
For HHAs that DO submit quality data
For HHAs that DO NOT submit quality data
CY 2011 LUPA addon amount for HHAs
that DO submit quality
data
Multiply by the 3 percent rural add-on
Total CY 2011 LUPA
add-on amount for
rural areas
CY 2011 LUPA addon amount for HHAs
that DO NOT submit
quality data
Multiply by the 3 percent rural add-on
Total CY 2011 LUPA
add-on amount for
rural areas
$93.31
× 1.03
$96.11
$91.46
× 1.03
$94.20
TABLE 13A—TOTAL CY 2011 CONVERSION FACTOR FOR SERVICES PROVIDED IN RURAL AREAS
For HHAs that DO submit quality data
For HHAs that DO NOT submit quality data
Multiply by the 3 percent rural add-on
Total CY 2011
conversion factor for
rural areas
CY 2011 conversion
factor for HHAs that
DO NOT submit
quality data
Multiply by the 3 percent rural add-on
Total CY 2011
conversion factor for
rural areas
$52.54
emcdonald on DSK2BSOYB1PROD with RULES2
CY 2011 conversion
factor for HHAs that
DO submit quality
data
× 1.03
$54.12
$51.50
× 1.03
$53.05
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70417
TABLE 13B—RELATIVE WEIGHTS FOR THE 6-SEVERITY NRS SYSTEM FOR SERVICES PROVIDED IN RURAL AREAS
For HHAs that DO submit quality data
1
2
3
4
5
6
......................................
......................................
......................................
......................................
......................................
......................................
0 .....................................
1 to 14 ............................
15 to 27 ..........................
28 to 48 ..........................
49 to 98 ..........................
99+ .................................
E. Enrollment Provisions for HHAs
In the CY 2011 HH PPS proposed
rule, we proposed several payment
safeguard provisions designed to:
(1) Ensure that enrolling HHAs have
sufficient capital on hand to operate the
business; (2) improve our ability to
verify that HHAs that are changing
ownership meet and continue to meet
the Conditions of Participation for
HHAs as specified in 42 CFR part 484;
and (3) improve the quality of care that
Medicare beneficiaries receive from
HHAs.
1. HHA Capitalization
emcdonald on DSK2BSOYB1PROD with RULES2
a. Background
As stated in the CY 2011 HH PPS
proposed rule, in the January 5, 1998
Federal Register (63 FR 291) we
published a final rule that required an
enrolling HHA to furnish proof that it
has available sufficient funds—or
‘‘initial reserve operating funds’’
(IROF)—to operate the HHA for the
3 month period following the effective
date of its provider agreement. This
requirement, at § 489.28, was triggered
by our concern that HHAs were entering
the Medicare program without sufficient
funds, which could, as stated in the
preamble to the January 5, 1998 final
rule, have deleterious consequences on
patient care. We stated therein:
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
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for HHAs that
DO submit
quality data
Points
(scoring)
Severity level
16:59 Nov 16, 2010
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$14.18
51.18
140.34
208.51
321.53
553.00
Multiply by
the 3 percent rural
add-on
×
×
×
×
×
×
1.03
1.03
1.03
1.03
1.03
1.03
......
......
......
......
......
......
$14.61
52.72
144.55
214.77
331.18
569.59
In the January 5, 1998 preamble, we
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 concerns 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.
We noted in the CY 2011 HH PPS
proposed rule that our Medicare
contractors have traditionally
determined the provider’s compliance
with the capitalization provisions in
§ 489.28 prior to making their
recommendation for approval to the
State Agency and CMS Regional Office
(RO). This can occur many months
before the HHA signs its provider
agreement. To ensure that the HHA
maintains its required level of
capitalization during this potentially
lengthy period—as well as during the
period between when it signs said
agreement and the time it is granted
Medicare billing privileges (a period
which also can last several months)—we
proposed at § 489.28(a) to require the
HHA to ‘‘have available sufficient funds
Frm 00047
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Sfmt 4700
NRS Payment amount
for HHAs that
DO NOT
submit quality
data
Total NRS
payment
amount for
rural areas
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.
PO 00000
For HHAs that DO NOT submit quality
data
$13.89
50.17
137.57
204.38
315.17
542.06
Multiply by
the 3 percent rural
add-on
×
×
×
×
×
×
1.03
1.03
1.03
1.03
1.03
1.03
......
......
......
......
......
......
Total NRS
payment
amount for
rural areas
$14.31
51.68
141.70
210.51
324.63
558.32
* * * at the time of application
submission and at all times during the
enrollment process to operate the HHA
for the 3 month period after Medicare
billing privileges are conveyed by the
Medicare contractor.’’
We believe that confirming
capitalization more than once during
this process would address our concern
that a provider may have redirected
these funds—which were originally
secured exclusively to meet the
capitalization requirements—for a
purpose other than to operate the
business. Indeed, situations have arisen
in which an HHA no longer has
sufficient capitalization at the time it is
enrolled in Medicare. This defeats the
policy behind § 489.28, which is to
ensure that HHAs are adequately
capitalized when they become Medicare
providers. Accordingly, we believe that
a prospective HHA must meet and
maintain adequate capitalization during
the entire period between when it
submits its enrollment application to
the Medicare contractor up to 3 months
after the contractor conveys Medicare
billing privileges to the HHA. This will
ensure that the HHA 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, and when
Medicare billing privileges are
conveyed.
b. Proposed Provisions
We proposed the following provisions
related to capitalization:
• In § 424.510, we proposed to add
the IROF requirement specified in
§ 489.28(a), so as to make it an
enrollment requirement for prospective
HHAs.
• In § 424.530(a)(8), we proposed to
deny Medicare billing privileges to a
prospective HHA if it could not furnish
supporting documentation (within 30
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days of a CMS or Medicare contractor’s
request) verifying that it met the IROF
requirement specified in § 489.28(a). We
also proposed to deny Medicare billing
privileges to a prospective HHA that
failed to meet the IROF requirement at
§ 489.28(a).
• In § 424.535(a)(11), we proposed to
revoke Medicare billing privileges and
the corresponding provider agreement if
the enrolled HHA was not able to
furnish supporting documentation
(within 30 days of a CMS or Medicare
contractor’s request) verifying that it
met the IROF requirement specified in
§ 489.28(a).
• In § 489.28(a), we proposed to
require that the HHA have available
sufficient IROF at the time of
application submission, and at all times
during the enrollment process to operate
the HHA for the 3 month period after
Medicare billing privileges are conveyed
by the Medicare contractor (exclusive of
actual or projected accounts receivable
from Medicare).
• In § 489.28(c), we proposed to add
a new paragraph (1) to reemphasize that
the Medicare contractor, in selecting
comparative HHAs for the purpose of
calculating the enrolling HHA’s
required level of capitalization, could
only select HHAs that submitted cost
reports to Medicare.
• In § 489.28(g)(1), we proposed to
establish that CMS may deny Medicare
billing privileges to an HHA unless the
HHA meets the initial reserve operating
funds requirements of this section.
• In § 489.28(g)(2), we proposed to
establish that CMS may revoke the
Medicare billing privileges of an HHA
that fails to meet the initial reserve
operating funds requirements of this
section within three months of receiving
its billing privileges.
c. Analysis of and Responses to Public
Comments
The following is a summary of the
comments received on our proposed
capitalization provisions, and our
responses thereto:
Comment: Several commenters
expressed support for our proposal to
require multiple instances of
capitalization verification between the
time an application is submitted up to
3 months after the contractor conveys
Medicare billing privileges. One
commenter stated that the proposed
capitalization requirement would
reduce the risk that incoming providers
will have inadequate funds to operate.
The commenter added that the provider
enrollment process can take several
months or more; thus, expanding
Medicare’s authority to verify the IROF
more than once is a reasonable
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safeguard. Another commenter stated
that the proposed capitalization
requirements are important to ensure
that new HHAs have adequate resources
to provide quality care to patients.
Response: We appreciate the support
of these commenters.
Comment: One commenter stated that
the signing of a provider agreement
signifies that the HHA has met the
requirements to receive payment. The
commenter also stated that proposed
§ 489.28(g)(2) allows CMS to enter into
a provider agreement before verification
of capitalization is performed at the
point that billing privileges are
conveyed. From this, the commenter
seemed to imply that verification of
capitalization after the conveyance of a
provider agreement is inappropriate,
since the provider has already—via the
provider agreement—been deemed to
have met the Medicare requirements for
participation, including the
capitalization requirements. The
commenter recommended that we:
(1) Verify the IROF at the time of
enrollment, the time of the initial
survey, and the time the provider
agreement is signed; and (2) delete
proposed § 489.28(g)(2), as it conflicts
with § 489.28(g)(1), which does not
allow CMS to convey billing privileges
until IROF requirements have been met.
Response: In the August 16, 2010 final
rule titled, ‘‘Medicare Program; Hospital
Inpatient Prospective Payment Systems
for Acute Care Hospitals and the Long
Term Care Hospital Prospective
Payment System Changes and FY 2011
Rates; Provider Agreements and
Supplier Approvals; and Hospital
Conditions of Participation for
Rehabilitation and Respiratory Care
Services; Medicaid Program:
Accreditation for Providers of Inpatient
Psychiatric Services; Final Rule,’’ we
revised the effective date of provider
and supplier agreements at § 489.13.
Specifically, section 489.13 was revised
to clarify that the date of a Medicare
provider or supplier approval may not
be earlier than the latest date on which
all applicable Federal requirements
have been met, and that such
requirements include review and
verification of an application to enroll
in the Medicare program by CMS’s
legacy fiscal intermediary, legacy
carrier, or Medicare Administrative
Contractor (MAC). These clarifications
were necessary because a September 28,
2009 decision of the Appellate Division
of the Department of the Appeals Board
(DAB) that interpreted § 489.13 as not
including enrollment application
processing among the Federal
requirements that must be met.
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Accordingly, the August 16, 2010
final rule mentioned above revised
§ 489.13(b) to state,’’ Federal
requirements include, but are not
limited to—
(1) Enrollment requirements
established in Part 424, Subpart P, of
this chapter. CMS determines, based
upon its review and verification of the
prospective provider’s or supplier’s
enrollment application, the date on
which enrollment requirements have
been met;
(2) The requirements identified in
§ 489.10 and § 489.12; and
(3) The applicable Medicare health
and safety standards, such as the
applicable conditions of participation,
the requirements for participation, the
conditions for coverage, or the
conditions for certification.’’
Thus, Medicare billing privileges are
conveyed by the Medicare contractor,
not through the issuance of a provider
agreement. That is, even though the
provider has signed a provider
agreement, the provider must, after that
point, still continue to meet all
enrollment requirements before the
contractor conveys Medicare billing
privileges. Moreover, as stated in this
final rule, one of those requirements is
the maintenance of adequate
capitalization. In fact, even after billing
privileges are conveyed, the provider
must meet the capitalization
requirement for another 3 months. This
is consistent with the Medicare
enrollment requirement in 42 CFR
424.500 et seq. that the provider remain
in compliance with all enrollment
requirements once it is enrolled in
Medicare.
With respect to the commenter’s
request to delete § 489.28(g)(2) because
it conflicts with § 489.28(g)(1), we
believe there is no conflict. Section
§ 489.28(g)(2) provides that the
capitalization requirements be
maintained for 3 months after billing
privileges are conveyed—much like the
requirement that the provider continue
to meet other enrollment requirements
after it is enrolled in Medicare. Section
§ 489.28(g)(1), on the other hand,
provides that capitalization
requirements must be met before billing
privileges are conveyed. The provisions,
in other words, are not mutually
exclusive. They simply cover two
different timeframes.
Nevertheless, to alleviate any
confusion on this issue, we have revised
§ 489.28(a) to reemphasize that the HHA
must maintain capitalization during the
3 month period following its receipt of
Medicare billing privileges.
Comment: Several commenters stated
that if CMS intends for HHAs to
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maintain capitalization 3 months after
they are able to bill Medicare, this does
not comport with the provisions of
§ 489.28(g), even after these provisions
are changed pursuant to this rule. This
is because § 489.28(g) will still state that
CMS will only convey Medicare billing
privileges to an HHA that satisfies its
IROF requirement. Another commenter
also requested clarification on how our
proposed changes are consistent with
the current verbiage in § 489.28(g).
Response: As indicated in our
response to the previous commenter, the
HHA will still be required to satisfy the
IROF requirement before receiving
Medicare billing privileges. However,
the HHA will also be required to
maintain the IROF level during the first
3 months after receiving billing
privileges. These two requirements,
again, are not inconsistent, but merely
address two different timeframes. We
have revised § 489.28(a) to make this
point more clear.
Comment: One commenter stated that
the new capitalization rules could
hinder the creation of new HHAs,
which, in turn, could harm underserved
areas, and that the closure of a new
HHA because of the new requirements
could disrupt patient care. The
commenter recommended flexibility
and discretion in applying the
capitalization requirements when the
HHA’s failure to meet the required IROF
levels is superseded by the need for the
HHA in that community, or when the
HHA’s financial condition on a
prospective basis suggests that it will
likely become financially viable.
Response: While we understand and
appreciate the commenter’s concerns,
we feel, for reasons already stated, that
it is important for incoming HHAs to
meet and maintain the capitalization
amount specified by the Medicare
contractor at the time of enrollment,
throughout the enrollment process, and
during the first 3 months after Medicare
billing privileges are conveyed. We
note, moreover, that if a HHA’s
Medicare billing privileges are denied or
revoked for failing to meet the
capitalization requirements, the HHA is
afforded administrative appeal rights
pursuant to the procedures set forth in
42 CFR part 498.
Comment: One commenter stated that
it is unclear whether CMS will require
HHAs to show capitalization more than
3 months after they are able to bill the
Medicare program.
Response: Section 489.28(a) of the
final rule states that the HHA must
maintain capitalization up to 3 months
after Medicare billing privileges have
been conveyed to the provider.
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Comment: One commenter stated that
the proposed provisions lack clarity as
to when an HHA will be required to
show capitalization.
Response: We believe that § 489.28(a)
is clear as to the points at which proof
of capitalization must be shown.
Comment: One commenter
recommended that CMS ensure there is
transparency throughout the
capitalization process. Specifically, the
commenter urged CMS to make certain
that the applicant: (1) Is able to
determine how much capitalization is
needed at the time it submits its
application through the last stage of the
review process; (2) is notified if or when
the capitalization amount changes and
give the applicant sufficient time to
secure any capitalization shortfall; and
(3) is subject to capitalization standards
that are evidence-based and reviewable
by an objective and independent person
or entity. Another commenter
recommended that CMS require each
contractor to: (1) Publish the
methodology used to calculate IROF
levels for a particular region or State;
(2) use current cost report data for each
calendar year; and (3) publish ranges of
IROF based on current cost report data.
Response: We will ensure that:
(1) Sufficient information is available to
HHAs prior to submitting their
enrollment applications so they know
what the appropriate capitalization
levels are and the justification for and
basis behind them; (2) incoming HHAs
are notified when their required
capitalization amounts change; and (3)
our Medicare contractors calculate the
IROF amount consistent with existing
regulations and the provisions in this
final rule. Moreover, we expect that our
contractors will make annual
adjustments to the IROF to ensure that
the capitalization amount is based on
current full cost report data.
Comment: One commenter indicated
that the proposed clarification in
§ 489.28(c)(1) regarding the use of cost
reports when selecting comparative
HHAs is superfluous, since § 489.28(c)
is already clear on this point.
Response: Though we agree that
§ 489.28(c) already discusses this topic,
we have clarified in this final rule that
Medicare contractors will use full cost
report data to calculate the IROF
amount. As such, Medicare contractors
will exclude from the IROF calculation
those HHAs that do not submit cost
report data or that submit low
utilization cost report data, as defined in
existing program guidance.
Comment: A commenter stated that
§ 489.28(a) holds that the IROF is to be
used to operate the HHA for the 3
month period after its Medicare
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70419
provider agreement becomes effective.
Requiring an HHA to show proof of
IROF 3 months after billing privileges
have been conveyed will not allow the
agency to use these funds as intended
by the rule.
Response: We do not agree that the
HHA would be unable to use these
funds during the first 3 months of
operations. Section 489.28(a) simply
states that the provider must have
adequate capitalization on hand to
operate the business for the 3 month
period after billing privileges are
conveyed.
Comment: One commenter stated that
the need to show capitalization three
times places a tremendous financial
burden on prospective HHAs that are
providing care to patients while
awaiting reimbursement approval.
Response: We believe this comment
underscores our concern about
undercapitalized HHAs enrolling in
Medicare. Moreover, since most
businesses receive monthly banking
statements or have ready access to
information about their financial net
worth, we do not believe that it is
burdensome to furnish this information
upon a Medicare contractor’s request.
2. HHA Changes of Ownership
a. Background
In the CY 2010 HH PPS proposed
rule, we also addressed the issue of
HHA ‘‘flipping’’ (e.g., rapidly selling the
HHA), or the HHA ‘‘certificate mill’’
process. We explained in detail how
this process works and our concerns
about it in the preamble to that August
13, 2009 rule (74 FR 40948):
We have recently found instances where
owners of a HHA, some of which were
working in concert with brokers or
organizations operating ‘turn-key’ businesses,
have enrolled or have attempted to enroll in
the Medicare program for the specific
purpose of selling the Medicare billing
privileges and the Medicare provider
agreement of their HHA to a third-party. In
this scenario, the buyer or seller of the HHA
typically would notify Medicare of the sale
or change of ownership via the Medicare
enrollment application (CMS–855A) after the
billing privileges have been transferred when
the HHA is sold.
Current CMS policy recommends surveys
when there is a change of ownership.
However, surveys in cases of a change of
ownership do not occur with the frequency
that they do when providers initially enroll
in Medicare. Consequently, there are
instances in which a change of ownership
takes place yet the new owner does not
undergo a survey, in which case Medicare
cannot conclusively ascertain whether the
business, under new ownership, meets the
Conditions of Participation under 42 CFR
part 484. This serves as an incentive for
certain prospective providers to enroll in the
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Medicare program with the sole purpose of
transferring Medicare billing privileges and
the associated provider agreement when the
business is sold.
This is problematic for two reasons. First,
the prospective provider has minimal
incentive for ensuring quality care for its
patients after it is enrolled because its
exclusive objective for participating in
Medicare in the first place is to sell the
business shortly after receiving Medicare
billing privileges. In other words, the
provider, aware that it may be able to sell the
business without the HHA having to undergo
a survey, may have little motivation to ensure
that it is in compliance with the Conditions
of Participation under 42 CFR part 484, since
it intends on selling the business in any
event. Medicare beneficiaries, therefore, may
receive inadequate services as a result of this
activity. Second, without the protection that
a survey provides, the HHA may attempt to
bill Medicare for these insufficient services.
These circumstances increase the risk for an
HHA to submit inappropriate and potentially
fraudulent claims to Medicare, which places
the Medicare Trust Funds at risk.
In short, under this scenario,
entrepreneurs apply for Medicare HHA
certification, undergo a survey, and
become enrolled in Medicare, but then
immediately sell the agency. 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 to enter the
Medicare program through the back
door—via the change of ownership
process—without having to undergo a
State survey. Because of this
circumvention of the State survey
process, we have no way of knowing
whether the HHA, under its new
ownership, is still in compliance with
the HH conditions of participation.
Largely to address this concern, we
proposed in § 424.550(b)(1) of the CY
2010 HH PPS proposed rule 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: (1)
Enroll in the Medicare program as a new
HHA under the provisions of § 424.510;
and (ii) obtain a State survey or an
accreditation from an approved
accreditation organization.
We received several comments
supporting the establishment of this ‘‘36
month rule’’ and did not receive any
specific recommendations that we
establish exceptions thereto. We
therefore left § 424.550(b)(1) largely
intact in the 2010 HH PPS final rule.
However, we did reiterate in that rule
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that the 36-month provision was not
only designed to deal with the specific
issue of ‘‘flipping,’’ but to also address
the broader problem of new owners of
HHAs entering the program without a
State survey being performed:
We wish to make clear that the intent of
42 CFR § 424.550(b)(1) goes beyond the issue
of ‘‘turn-key’’ operations. If an HHA
undergoes a change of ownership, CMS—at
the current time—generally does not perform
a State survey pursuant thereto. CMS
therefore has no sure way of knowing
whether the HHA, under its new ownership
and management, is in compliance with the
HHA conditions of participation—regardless
of whether the ownership change occurred
12, 24, or 36 months after the HHA’s initial
enrollment. Unless CMS can make this
determination, there is a risk that the newlypurchased HHA, without having been
appropriately vetted via the survey process,
will bill for services when it is out of
compliance with the conditions of
participation. And in light of the frequency
of inappropriate practices, as outlined in the
GAO report, of HHAs relative to other
provider types, we believe it is imperative
that we ensure that the newly-purchased
HHA be subject to an appropriate level of
review. (74 CFR 58118)
The effective date of § 424.550(b)(1)
was January 1, 2010.
b. Proposed Provisions
After the implementation of
§ 424.550(b)(1), we received a number of
comments regarding the impact of this
provision on bona fide ownership
transactions. Therefore, in this year’s
HH PPS proposed rule, we proposed to
revise § 424.550(b)(1), and to establish
several exceptions:
• In § 424.502, we defined the term
‘‘change in majority ownership’’ to mean
when an individual or organization
acquires more than a 50 percent interest
in an HHA during the 36 months
following its initial enrollment into the
Medicare program or a change of
ownership (including asset sales, stock
transfers, mergers, or consolidations).
This would include an individual or
organization that acquires majority
ownership in an HHA through the
cumulative effect of asset sales, stock
transfers, consolidations, and mergers
during a 36 month period.
• In § 424.550(b)(1), we proposed that
any change in majority ownership
within 36 months after the effective date
of the HHA’s enrollment in Medicare
(including asset sales, stock transfers,
mergers or consolidations) would
require the entity to enroll as a new
HHA and undergo a State survey or
obtain accreditation.
• In § 424.550(b)(2)(i), we proposed to
exempt from § 424.550(b)(1) a publiclytraded company that is acquiring
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Fmt 4701
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another HHA, and both entities
submitted cost reports to Medicare for
the previous 5 years.
• In § 424.550(b)(2)(ii), we proposed
to exempt from § 424.550(b)(1) an HHA
parent company that is undergoing an
internal corporate restructuring, such as
a merger or consolidation, and the HHA
submitted a cost report to Medicare for
the previous 5 years.
• In § 424.550(b)(2)(iii), we proposed
to exempt from § 424.550(b)(1) those
situations where the owners of an
existing HHA are changing its existing
business structure (for example,
partnership to a limited liability
company; sole proprietorship to
subchapter S corporation), but the
individual owners remain the same and
there is no change in majority
ownership.
• In § 424.550(b)(2)(iv), we proposed
to exempt from § 424.550(b)(1) those
ownership changes involving the death
of an owner who owns a 49 percent or
less interest in an HHA (where several
individuals or organizations are coowners of an HHA and one of the
owners dies).
We proposed these exceptions to
account for certain legitimate
transactions that might be unduly
affected by the 36-month rule. However,
as we stated in the proposed rule, our
decision to do so in no way alleviated
our ongoing concerns about the
‘‘certificate mill’’ process. We also
remained concerned about the broader
ability of new HHA owners to enter
Medicare through the back door via the
change of ownership process, as
opposed to the initial enrollment and
State survey mechanism.
c. Analysis of and Responses to Public
Comments
The following is a summary of the
comments received regarding the 36month rule, and our responses thereto:
(1) General Application of Rule
Comment: One commenter expressed
support for the 36-month rule, as well
as for our proposed changes and
exceptions. The commenter stated that
the rule is one means to reduce the
number of new HHAs that: (1) Are
entering Medicare ill-equipped to
provide high-quality care; and (2) easily
fall into patterns of behavior that hurt
the integrity of the Medicare program.
Another commenter stated that the
additional clarification to the 36-month
rule was positive.
Response: We appreciate and agree
with these comments.
Comment: One commenter stated that
the survey of an HHA that has changed
owners would seem appropriate. New
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owners/operators may not be welleducated on home care rules and
regulations, and surveys of such
agencies would often be in the patients’
best interests. Exceptions might be
considered when another alreadycertified and operating HHA with a
proven track record purchases another
HHA. Still, care transitions and
managerial changes can place patient
care at risk. Timely and targeted surveys
may avoid many problems later on, both
for the purchased HHA and its patients.
Response: We appreciate this
comment, and share the commenter’s
belief that surveying new owners would
be in the best interests of the HHA’s
patients.
Comment: Several commenters
recommended that we limit the
applicability of the 36-month rule to
ownership changes occurring within 36
months after the effective date of the
HHA’s initial enrollment in Medicare,
rather than within 36 months after the
HHAs most recent ownership change.
One commenter added that this single
change would eliminate the most
significant problems created by the
proposed rule.
Response: We believe that applying
§ 424.550(b)(1) to ownership changes
that occur within 36 months of: (1)
Initial enrollment and (2) the HHA’s
most recent ownership change, is
needed to ensure that newly-sold HHAs
are in compliance with the conditions of
participation.
Comment: Several commenters
recommended that we rescind the
current 36-month rule and establish a
technical advisory committee with
experts from home care and the finance
sector to establish guidelines that will
ensure that patient care remains the top
priority for existing and new home care
agencies.
Response: We disagree that a
technical advisory committee is needed
to address the provisions of the 36month rule. We believe that the
comments received in response to our
proposal and our subsequent changes
will result in improved patient care and
financially viable HHAs.
Comment: Several commenters stated
that the proposed provisions constitute
an expansion of the 36-month rule that
would block new investments in the HH
industry, which, in turn, could inhibit
necessary industry consolidation and
prevent providers from expanding. The
commenters generally believed that the
costs of the proposed revisions
outweigh any benefits to the Medicare
program or its beneficiaries. Another
commenter stated that revising the rule
to ensure that capital is available will
lead to better patient care outcomes,
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fewer issues in the operations of HHAs,
and increased innovations that will
lower the overall costs of care.
Response: We disagree with the
assertion that the costs of the proposed
rule outweigh its benefits. Beyond the
issue of ‘‘certificate mills’’ and HHAs’
‘‘flipping’’ ownership to a third-party,
we remain concerned about: (1) The sale
or transfer of HHAs that have little or no
enterprise value except the Medicare
billing number, and (2) new owners
entering Medicare without the HHA
having to undergo a State survey.
Comment: Several commenters stated
that for many HHAs that have been
enrolled in Medicare for more than 36
months (or even less than 36 months),
the proposed rule will deprive them of
access to capital, in that no existing
HHA can afford to lose its Medicare
participation until a new survey is
conducted, a process which can take
many months. No ongoing business, the
commenters stated, can continue to
incur expenses with no revenue during
that time, and that patient care could
therefore suffer. Several commenters
further contended that by expanding the
rule to apply to changes occurring more
than 36 months after initial enrollment,
banks will not loan money to, private
equity firms will not invest in, and
quality HHA organizations will not
purchase, existing HHAs. This is
because the bank/purchaser realizes it
will be unable to effectively (a) foreclose
upon, or (b) sell its majority interest in
the business, due to the need to enroll
as a new provider and undergo a survey.
The commenters stated that some
financiers have, since the
implementation of § 424.550(b)(1),
declined to loan money to HHAs
because of these concerns, with one
commenter adding that this closing of
access to funds does not help address
the issue of ‘‘flipping.’’ One commenter
added that CMS should not require
enhanced capitalization in one section
of the proposed rule while denying
access to that capital in another.
Another commenter stated that many
entities will avoid the HHA business
entirely if they cannot exit their
investment for 36 months or obtain
capital. Meanwhile, enrolled HHAs,
another commenter noted, will be
reluctant to exit Medicare, which could
prove problematic for Medicare if the
HHA is poorly-performing or of lowquality. Another commenter stated that
lenders already perform due diligence
on the HHA before loaning it money.
This important safeguard is lost if
lenders will not loan funds to the HHA
because of the 36-month rule.
Response: As already stated, the 36month rule is designed to ensure that
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enrolled HHAs comply with the HHA
conditions of participation and furnish
quality services to Medicare
beneficiaries. Nevertheless, we have
adopted, as explained below in more
detail, certain exceptions to the 36month rule. We believe these exceptions
will help ensure that HHAs are able to
obtain financing, while at the same time
protecting the integrity of the Medicare
program.
Comment: One commenter suggested
that rather than require an HHA to
reenroll in Medicare, the entity should
instead have to obtain re-accreditation
from an approved accreditation
organization within 6 months of the
ownership change. If reaccreditation is
obtained within this period, the
reenrollment process should not be
required. If reaccreditation is not
obtained, reenrollment would be
necessary. The commenter believed that
the reaccreditation process would be a
faster and more cost-effective way to
identify and stop the certificate mill
process, and would not result in a gap
in reimbursement for legitimate HHAs
or a reduction in services for patients.
Another commenter stated that the HHA
should still be able to bill Medicare
while awaiting the survey. This will
prevent a disruption of services.
Response: Though we appreciate
these comments, our concern is that
during the period in which the HHA is
waiting for the survey to be performed,
an entity that is potentially out of
compliance with the conditions of
participation because of its ownership
change may be billing Medicare for
services it is not qualified to provide.
Accordingly, we are not adopting these
recommendations.
Comment: A commenter stated that
although the survey requirement of the
36-month rule is essentially based on
the old owner’s conduct—that is, the
owner’s sale of its HHA—it is the new
owner that must undergo the survey.
The commenter believed this was
somewhat unfair.
Response: We disagree. In the
commenter’s scenario, the buyer is
voluntarily agreeing to purchase the
HHA. If a prospective buyer is
uncomfortable with undergoing a
survey, it need not proceed with the
sale. Moreover, by ensuring that the
HHA has submitted full cost reports, we
believe this information will assist the
buyer in establishing a fair valuation for
the HHA it is purchasing.
Comment: One commenter questioned
the value of § 424.550(b)(1) on two
grounds. First, if an owner has operated
a Medicare-enrolled HHA for at least 36
months, it is clear that it is not a broker
looking to immediately ‘‘flip’’ the HHA
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after enrollment. Second, an HHA can
easily circumvent the 36-month rule by
simply not disclosing the ownership
change; the commenter suggested that
by the time CMS learns of the
transaction, it may be too late. Several
commenters contended that the rule is
only triggered when the HHA selfreports the change in ownership to
CMS. Legitimate businesses that are
willing to self-report under these
circumstances are not the types of
entities that generally pose a risk to
Medicare. It therefore follows that the
36-month rule will prevent only
legitimate transactions from taking
place. Another commenter stated that if
an HHA is enrolled for more than 36
months, this should be adequate proof
that the entity is not a certificate mill.
Hence, the rule should only apply to the
first 36 months of enrollment.
Response: With respect to the first
comment, we have, as previously
mentioned, elected to apply
§ 424.550(b)(1) to ownership changes
that occur within 36 months of:
(1) Initial enrollment, and (2) the HHA’s
most recent ownership change. Again,
our concerns go beyond the issue of
‘‘flipping,’’ and touch on the larger
question of whether a newly-sold HHA
is still in compliance with the
conditions of participation.
Regarding the remaining comments,
we note that—under the Medicare
enrollment regulations at 42 CFR
424.500 et seq.—a failure to report an
ownership change to CMS can result in
a: (1) Retroactive revocation of the
provider’s Medicare billing privileges,
and (2) a bar against reenrolling in
Medicare for a period of 1 to 3 years.
Hence, it is to the provider’s advantage
to self-report the ownership change, for
failing to do so could keep the provider
out of Medicare for a much longer
period if the provider’s billing privileges
are revoked. Moreover, § 424.550(b)(1) is
triggered when the change of ownership
occurs, rather than whether it is
reported. In other words, it is not the
submission of a CMS–855A ownership
change application that implicates
§ 424.550(b)(1), but the ownership
change itself.
Comment: Several commenters stated
that § 424.550(b)(1) was inconsistent
with section 1891(c)(2)(B)(i) of the Act.
They contended that Congress did not
intend for State surveys to take place
every time there is a change of
ownership, and that if a survey was
nevertheless necessary, it had to occur
within 2 months of the change. The
commenters believed that CMS has
therefore exceeded the authority
provided to the Secretary under section
1891(c)(2)(B)(i).
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Response: We disagree. Nothing in the
statute itself prohibits us from enacting
§ 424.550(b)(1). Section 1891(c)(2)(B)(i)
gives CMS the discretion to perform a
survey within 2 months if a change of
ownership has occurred. This issue was
discussed in the legislative history of
this provision, which read in part:
The Committee amendment would
authorize the States and the Secretary to
conduct a standard survey, or an abbreviated
version of a standard survey within 2 months
after any change in ownership,
administration, or management of a facility,
as well as after a change in the director of
nursing. (H.R. Rep. 100–391(I), 1987
U.S.C.C.A.N. 2313–1) (Emphasis added).
However, as both the statute and the
aforementioned language indicate, we
are not mandated to take this action
within the 2 month period. In addition,
while we appreciate the need for
surveys in such situations to be
conducted as rapidly as possible, State
survey workloads generally do not
permit them to happen within 2 months
of the change.
Comment: Several commenters stated
that instead of requiring a new
enrollment and survey—a process
which could take an extended period of
time—CMS should use its authority
under section 1891(c)(2)(B)(i) to conduct
a survey of a sold HHA within 2 months
of the sale’s effective date. They added
that the § 424.550(b)(1) survey
requirement will further burden State
survey agencies and accreditation
organizations. In light of this, they
questioned the need for such surveys if
both the buyer and seller are legitimate
businesses, as shown by their
submission of cost reports for 36
months.
Response: While we appreciate this
suggestion, the commenters seem to
imply that we do not have the authority
to conduct a survey outside of that
referenced in section 1891(c)(2)(B)(i) of
the Act. As already indicated, we do not
agree. We further note that a survey
performed pursuant to § 424.550(b)(1) is
of a new HHA, not an existing one; this
is because § 424.550(b)(1) requires the
HHA to enroll as a new provider.
Comment: One commenter suggested
that CMS hold that an HHA provider
number will not transfer upon an
ownership change unless either: (1) The
new owner has successfully been
through the State survey or
accreditation process and the parent
company has filed cost reports on behalf
of other HHAs it owns for 36 months;
or (2) the HHA being purchased has
filed cost reports for at least 36 months.
This would, the commenter explained,
significantly curtail, if not eliminate, the
certificate mill process.
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Response: As already explained, our
concerns are not limited to the
‘‘flipping’’ process. We are also
concerned with ensuring that newlysold HHAs are still in compliance with
the conditions of participation.
Nevertheless, we have adopted an
exception to the 36-month rule that is
consistent with the commenter’s second
suggestion.
Comment: Several commenters stated
that the primary intent of this provision
was to stem the practice of turn-key
ventures that establish HHAs for the
sole purpose of selling them. The
commenters argued that the proposed
rule exceeds this intent.
Response: We disagree that this rule
exceeds its intent. Again, aside from the
issue of ‘‘flipping,’’ we believe it is
crucial for Medicare to ensure that
entities undergoing an ownership
change remain in compliance with the
conditions of participation. We believe
the final rule helps fulfill this intent.
Comment: One commenter stated that
the proposed changes are confusing and
discriminatory, that the rule conflicts
with existing law regarding transfers of
ownership, and will effectively halt all
mergers and acquisitions in the HH
industry unless the HHA is a public
company. The commenter stated that
many HHAs are small companies, and
their investment in our communities
should be protected.
Response: We are unable to address
the commenter’s first and second
contentions, as the commenter did not
explain how the proposed rule is
confusing or discriminatory, or how it is
inconsistent with current laws regarding
ownership changes. With respect to the
third contention, we agree that the
volume of HHA ownership changes,
including asset sales and stock transfers,
could be reduced as a result of the 36month rule. Yet we also believe that the
exceptions outlined in this final rule
will allow a number of legitimate HHA
ownership changes to proceed.
Comment: Several commenters stated
that no evidence of the ‘‘certificate mill’’
problem has been substantiated by CMS.
Another commenter stated that CMS has
not defined or described the program
integrity or quality of care concerns that
the proposed rule is designed to
address, nor has CMS identified the
harm caused by the ‘‘flipping’’ process.
This commenter added that if CMS’s
concerns go beyond the issue of
‘‘flipping,’’ this needs to be clearly
disclosed so that comments can be
furnished.
Response: We disagree with these
assertions. In the proposed and final
rules for CY 2010 and 2011, we clearly
articulated our concerns about this
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problem and stated that we have
uncovered instances where entities have
enrolled in Medicare for the specific
purpose of selling their HHAs to other
entities looking to obtain Medicare
billing privileges. We further explained
that this practice allows a new entity to
enter Medicare without having to
undergo a State survey, which therefore
raises questions as to whether the HHA
is furnishing quality services to
Medicare beneficiaries. In the 2010
proposed and final rules, we also
articulated why this issue is especially
disconcerting in light of the program
integrity issues prevalent in the HHA
community. In addition, we have
consistently explained our concerns
about the need to verify that newly-sold
HHAs—even those not specifically
engaged in the practice of ‘‘flipping’’—
are in compliance with the conditions of
participation.
Comment: One commenter stated that
a change in majority ownership does not
necessarily imply a change in the
management of the HHA’s day-to-day
operations. A survey should be
conducted only if the majority
ownership change is accompanied by
other factors that raise questions about
the entity’s compliance. In other words,
surveys pursuant to § 424.550(b)(1)
should be conducted on a case-by-case
basis. Other commenters, too, expressed
concern about the ‘‘majority ownership’’
standard, and stated that CMS should
instead apply the definition of ‘‘change
of ownership’’ in § 489.18 to the 36month rule, or should require a 100
percent ownership change before
§ 424.550(b)(1) is triggered.
Response: While we agree that a
change in majority ownership of a
particular HHA may not always result in
a change in the HHA’s management, it
has been our experience that a change
in management routinely occurs when
there is a change in ownership.
Comment: Several commenters
recommended that the proposed
revisions to the 36-month rule be
applied prospectively only. Specifically,
the commenters believed that no
currently-enrolled HHA should be
subject to the rule, in that they entered
Medicare without a restriction on the
sale of the HHA other than those
existing at that time. At most, one
commenter stated, CMS should apply
the rule to HHAs initially enrolled in
Medicare on January 1, 2010 (the
effective date of the rule) or later.
Otherwise, applying the rule to HHAs
enrolled prior to that point will affect
the business’s value and financial
stability.
Response: For reasons already stated,
it is important for us to confirm that an
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entity undergoing an ownership change
is still in compliance with the HHA
conditions of participation.
Consequently, we do not believe that all
HHAs enrolled prior to January 1, 2010
should be exempt from the provisions of
this final rule. As an example, assume
that an HHA initially enrolled in
Medicare on July 1, 2009. The HHA is
subject to § 424.550(b)(1) through July 1,
2012, or 36 months after its date of
initial enrollment. If the HHA undergoes
a change in majority ownership on
September 1, 2011, it will be subject to
§ 424.550(b)(1) until September 1, 2014,
or 36 months after its most recent
ownership change.
Comment: Several commenters
expressed concern that § 424.550(b)(1)
would lead to beneficiaries that are
under treatment by an HHA undergoing
a § 424.550(b)(1) ownership change to
be denied certain services (or
discharged and compelled to find care
elsewhere), since the HHA will have to
enroll as a new entity. Another
commenter stated that this could also
lead to layoffs of the HHA’s staff.
Response: We disagree. As we have
stated in a number of forums, there is
no shortage of available HH services
throughout the country. A patient who
may be discharged under the
commenter’s scenario will retain access
to care via other HHAs within the
community. We do not think there is a
risk of a discharged beneficiary being
unable to obtain HHA services from
another provider.
Comment: A commenter suggested
that instead of the 36-month rule, CMS
should use its deactivation authority
under § 424.540 to deactivate the billing
privileges of an entity undergoing a
change of ownership until a State
survey is completed; additional
ownership changes could be prohibited
during that period. The new owner
would therefore receive payments, but
they would be delayed. This would be
consistent with § 424.540(b)(3)(i), which
mandates a survey prior to the
reactivation of an HHA’s billing
privileges. Likewise, another commenter
suggested that CMS, in the alternative:
(1) Require an HHA to notify CMS of the
forthcoming sale 60 days in advance
(and terminate the HHA if such notice
is not given); (2) suspend the HHA’s
billing privileges effective the date of
the sale; and (3) require the HHA to
undergo a State survey or obtain
accreditation within 6 months of the
ownership change. Failure to meet
either (1) or (3) would result in the
termination of the provider’s Medicare
enrollment.
Response: We appreciate these
suggestions. However, we believe that
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§ 424.550(b)(1) more adequately
furnishes the program safeguards we
seek because the HHA will be required
to enroll as a new provider and be
subject to all of the provider enrollment
and State survey vetting processes that
other new HHAs must undergo.
Comment: Another commenter
suggested that CMS mandate that a
provider agreement would not transfer
upon a change of ownership if both the
purchasing and selling entities: (1) Have
not successfully been through the State
survey process (or deemed accreditation
process); and (2) have never filed an
HHA cost report.
Response: We appreciate this
suggestion. The commenter’s first
criterion, however, is superfluous
because the enrolled HHA that is being
purchased will have already gone
through the State survey or
accreditation process prior to
enrollment. Moreover, the second
criterion makes no distinction between
full cost reports and low or no
utilization cost reports. Consequently,
under the commenter’s scenario, an
HHA could be exempt from the 36month rule so long as it submitted one
cost report—even if it was a no
utilization cost report. In light of this,
we do not believe the commenter’s
recommendation provides the necessary
program safeguards.
Comment: One commenter stated that
while the 36-month rule was wellfounded in purpose and intent, it will
negatively impact bona fide HHAs and
the patients they serve and should be
redesigned wholesale or significantly
revised to better balance the interests of
patients, providers, and Medicare. The
commenter recommended that CMS
work with the health care industry to
achieve the program integrity purposes
behind the rule.
Response: We believe the exceptions
in this final rule strike the necessary
balance between our program integrity
concerns and our desire to address some
of the issues raised by the HHA
industry.
Comment: One commenter stated that
the 36-month rule will create more harm
than good. The commenter cited an
example of an HHA that is poorly run.
The HHA, rather than being able to
freely sell the business, would now be
encouraged to hold on to the HHA until
the 36-month clock expires. Another
commenter added that even in cases
where an HHA owner had every
intention of maintaining its ownership
for more than 36 months after its initial
investment, many personal and
professional circumstances can occur to
impact that timing.
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Response: Given the changes we have
adopted in this final rule, we believe
that the owner of an HHA as described
above would need to make the business
decision to remain in the Medicare
program or to exit the Medicare program
voluntarily.
Comment: Several commenters asked
for clarification as to whether indirect
ownership changes are subject to the 36month rule.
Response: Indirect ownership changes
are not subject to the 36-month rule. We
have clarified this in the regulatory text
of the final rule. However, CMS will
further analyze and monitor this issue,
and may consider modifying this policy
in future rulemaking.
Comment: One commenter suggested
that indirect ownership changes without
significant day-to-day management
changes be exempt from the 36-month
rule.
Response: As previously stated,
indirect ownership changes are not
subject to the 36-month rule.
Comment: A commenter stated that
with the termination of the provider
agreement upon the application of
§ 424.550(b)(1), Medicare loses the
assumption of Medicare liabilities that
come with the transfer of the provider
agreement.
Response: We appreciate this
comment, but believe that the 36-month
rule helps us address the program
integrity concerns we have outlined.
Comment: One commenter stated that
because many states require an HHA to
maintain a valid Medicare certification
as a condition of Medicaid enrollment,
loss of the HHA’s enrollment in
Medicare could prevent the entity from
furnishing Medicaid services.
Response: We understand the
commenter’s concern. However, we
believe that owners of an HHA need to
consider the impact of any changes of
ownership on all of their payer
relationships, not just Medicare.
Comment: One commenter stated that
CMS needs to apply caution in detailing
regulations that financially impact
legitimate HHAs and large numbers of
patients. This is especially true if, for
instance, a State is involved in
purchasing or selling a significant
number of HHAs and many CMS–855A
applications must be completed.
Response: We agree, and have
incorporated public comments into this
final rule that protect the Medicare
program while helping to ensure that
HHAs continue to have access to capital
markets.
Comment: One commenter stated that
several of CMS’s concerns about
certificate mills may be somewhat
misguided. The commenter cited
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verbiage in the CY 2010 and 2011 HH
PPS rules in which we stated that
certain HHA brokers sell the business
without having seen a patient or hired
an employee. The commenter stated that
the entity is required to provide services
to at least 10 patients prior to obtaining
a provider agreement.
Response: In this final rule, we have
incorporated the submission of a full
cost report for 2 years as an exception
to the 36-month rule. Accordingly, we
recognize that some HHAs do not
submit cost report data or submit low
utilization cost reports.
Comment: One commenter stated that
the 36-month rule will be extremely
damaging to the home care industry and
requested that CMS not implement it.
Response: Though we are unsure as to
the commenter’s specific concerns about
the 36-month rule, we believe, for
reasons already stated, that it is
necessary.
Comment: Several commenters asked
whether § 424.550(b)(1) applies if there
is a transfer between partners that
changes one person’s ownership interest
from 40 percent to greater than 50
percent. The commenters questioned
the provision’s applicability, since the
parties have not changed but have
simply shifted the assets between them.
Response: Section 424.550(b)(1)
applies if there is a change in majority
ownership. Since, in the example posed
by the commenters, there is a change in
majority ownership (that is, a person or
entity now owns over 50 percent of the
HHA) § 424.550(b)(1) indeed applies,
assuming the entity does not qualify for
an exception under § 424.550(b)(2).
Comment: One commenter stated that
there were two typographical errors in
the definition of ‘‘majority ownership’’
in § 424.502. First, the word ‘‘months’’
should immediately follow the phrase
‘‘during the 36.’’ Second, after ‘‘Medicare
program,’’ the phrase ‘‘or a change of
ownership’’ should be deleted.
Response: We have revised § 424.502
to incorporate the first change, but we
are not incorporating the second change.
(2) Exceptions
Comment: One commenter
recommended that if additional
assurance is required that an HHA is
indeed a viable agency and not being
‘‘flipped,’’ we could extend the
applicability of the proposed 36-month
rule to sales of HHAs that have never
filed a full cost report or that have filed
a no or low utilization cost report
pursuant to the Provider
Reimbursement Manual.
Response: We agree in part with this
commenter, and have adopted the use of
full cost reports in our exception criteria
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for the 36-month provision and in
§ 489.28(c)(1). Moreover, we agree that
an HHA must submit two or more
consecutive full cost reports before the
agency can receive an exception under
§ 424.550(b)(2)(i). It is also important to
note that we do not believe the
submission of a low utilization cost
report or no cost report for a given
practice location meets the full cost
report standard.
Comment: Several commenters
recommended that we adopt a public
company exception to the 36-month
requirement that states, ‘‘A company is
acquiring another company that is an
HHA (or is the parent company of one
or more HHAs) and the majority of the
HHAs being acquired are bona fide
operating HHAs that have submitted
cost reports to Medicare for the previous
36 months or longer.’’
Response: As already stated, an HHA
must submit two or more consecutive
full costs reports before it can qualify for
an exception under § 424.550(b)(2)(i).
We believe this exception would
effectively block all unwanted ‘‘license
flipping’’ transactions, while ensuring
that bona fide operating businesses can
obtain financing.
Comment: Several commenters
expressed concern over the proposed
exception in § 424.550(b)(2)(i) for
publicly-traded companies that
purchase an HHA. Among the
arguments they presented were that:
(1) It gives an unfair advantage to
publicly-traded firms, (2) it restricts
competition and is contrary to the
public interest; (3) private companies in
many cases have the resources and size
comparable to publicly-traded
companies; (4) a transaction by a
privately-held, bona fide HHA is no less
legitimate than one involving a
publicly-held company; (5) since the
statute does not give publicly-traded
HHAs any greater rights or privileges,
neither should the 36-month rule; (6)
the additional legal and oversight
requirements applicable to public
companies do not make a difference
with respect to compliance with
Medicare rules to warrant an exclusive
exception; and (7) because most HHAs
are small, privately-held companies that
lack the resources of some larger,
publicly-held companies, the latter have
an unfair advantage. Several of these
commenters also contended that
§ 424.550(b)(2)(i) should be expanded to
include private companies, and that
public and private companies should be
exempt if the HHA submitted cost
reports to Medicare for the previous 3
years. One commenter stated that this
will balance the need to protect the
Medicare program without restricting
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legitimate transactions. Another
commenter, believing that proposed
§ 424.550(b)(2)(i) is unfair, suggested
two additional exceptions. One was for
an individual or company that
purchases an HHA with an initial
investment of $15 million (or some
other substantial figure). The second
should be for buyers that already
operate one or more HHAs with
aggregate revenues of greater than $25
million. These prospective buyers, the
commenter stated, are not of the types
that intend to commit fraud.
Response: Section 424.550(b)(2)(i) has
been revised to apply to both private
and public companies.
Comment: One commenter stated that
the public-company exception should
be replaced with an exception for a
company acquiring another company
that is an HHA (or is the parent
company of one or more HHAs), and the
majority of the HHAs being acquired are
bona fide operating HHAs that have
submitted cost reports to Medicare for
the previous 36 months or longer. The
commenter defined ‘‘bona fide’’ as an
operating entity that employs caregivers,
provides services to beneficiaries and
other patients, and has filed Medicare
cost reports for the previous 36 months
or longer. Another commenter
recommended that CMS exempt from
the 36-month rule any ‘‘experienced’’
acquiring party, whether a public or
private company. The commenter
defined ‘‘experienced’’ as an HHA that
has had at least one survey within the
last 36 months.
Response: Section 424.550(b)(2)(i) has
been expanded to include any HHA that
has submitted 2 consecutive years of
cost reports (excluding low or no
utilization cost reports).
Comment: Several commenters
questioned why CMS did not propose
an exception for non-profit entities. One
commenter requested that CMS furnish
a rationale for this decision. Another
commenter stated that the transfer of
control of non-profit, tax-exempt HHAs
to another non-profit, tax-exempt entity
should be exempt from the 36-month
rule because of other safeguards that
prevent ‘‘flipping’’ transactions.
Response: Section 424.550(b)(2)(i) is
equally applicable to non-profit and forprofit entities.
Comment: One commenter believed
that the exceptions to the 36-month rule
were reasonable in view of the need to
accommodate legitimate changes in
ownership. The commenter added,
however, that while non-profits are not
engaged in buying and selling HHAs or
operating large national chains, nonprofits that must merge for financial or
other reasons should be offered full
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support by CMS to ensure the
continuation of service to vulnerable
patients.
Response: We appreciate the
commenter’s support for our proposed
exceptions to the 36-month rule and, as
already mentioned, non-profit entities
are included within the purview of
§ 424.550(b)(2)(i).
Comment: One commenter suggested
that any change in ownership of a
holding company that owns and
operates HHAs through subsidiaries be
exempt from the 36-month rule, so long
as that holding company has one or
more consolidated subsidiaries that
have submitted cost reports to Medicare
for at least 2 years.
Response: While we appreciate this
suggestion, it is moot because, as
already mentioned, indirect ownership
changes are not impacted by the 36month rule.
Comment: Several commenters
suggested that we establish an exception
to § 424.550(b)(1) to permit a qualifying
bank or other legitimate lending
institution to foreclose on a defaulted
loan and to permit the lender to, in turn,
sell the HHA to an accredited buyer.
Failure to do so will curtail the ability
of HHAs to secure financing, since
banks will be reluctant to loan money to
HHAs if, should the HHA collapse
financially, the bank will be unable to
foreclose on the business. Another
commenter agreed, stating that the
proposed 36-month rule eliminates the
option of foreclosure as security for
lenders.
Response: Since there is no enterprise
value to an HHA that is in bankruptcy
or where the lender forecloses (except
the Medicare billing number), we do not
believe that this exception should be
adopted in formal rulemaking. However,
we believe that we would be compelled
to follow a court order approving the
sale of an HHA.
Comment: Several commenters
suggested an exception for ownership
changes triggered by a bankruptcy with
court approval. This will allow the HHA
to obtain needed capital.
Response: As stated above, we will
comply with court orders, but we do not
believe that a bankruptcy exception to
the 36-month rule is necessary.
Comment: One commenter suggested
that we create an exception to
§ 424.550(b)(1) to allow a buyer that
already operates an accredited HHA to
acquire an unrelated HHA if the
accrediting body extends the buyer’s
accreditation to include the newlyacquired HHA. Accrediting
organizations, the commenter stated,
will only extend accreditation if they
are satisfied with the buyer’s ability to
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operate the HHA in accordance with its
standards.
Response: We appreciate this
suggestion. However, we believe that
§ 424.550(b)(1) and its associated
exceptions more adequately provide the
program safeguards we desire.
Comment: Several commenters stated
that the exception in § 424.550(b)(2)(iv)
is superfluous because the death of an
owner of 49 percent or less of the
business does not result in a change in
majority ownership anyway. The
commenters suggested that the
exception be revised to include the
death of a majority owner, provided the
remaining owners or partners retain
their ownership. One commenter
expressed concern that
§ 424.550(b)(2)(iv) applies only when a
deceased owner has less than a 50
percent ownership interest and that the
exception applies to all types of
business structures. This, the
commenter states, could cause the entity
undue hardship. Another commenter
stated that the transfer of ownership
from death should be completely
exempt from the 36-month rule, and
added that the currently proposed
exception does not clarify the types of
ownership interests to which it applies.
Response: We have revised
§ 424.550(b)(2)(iv) to state that the death
of an owner does not trigger the 36month rule.
Comment: A commenter requested
clarification of the term ‘‘several
individuals’’ as used in proposed
§ 424.550(b)(2)(iv), which reads: ‘‘The
death of an owner who owns 49 percent
or less interest in an HHA (where
several individuals or organizations are
co-owners of an HHA and one of the
owners dies.)’’ The commenter asked
whether a trust qualifies as an
‘‘individual.’’
Response: The term ‘‘several
individuals’’ refers to more than one
person, not to trusts. However, the
verbiage in parentheses was meant to
include all owners regardless of type. It
was used only to describe situations in
which an HHA has multiple owners. Yet
the issue is largely moot based on our
aforementioned revisions to
§ 424.550(b)(2)(iv).
Comment: One commenter asked
whether the exception in
§ 424.550(b)(2)(iv) applies if a
corporation owned by three people
establishes an HHA under a 49 percent,
49 percent, and 1 percent stock
ownership scenario, and one person
dies.
Response: As stated above, we have
revised § 424.550(b)(2)(iv) to state that
the death of an owner does not trigger
the 36-month rule.
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Comment: Several commenters
recommended that CMS reduce the cost
reporting time for the proposed
exceptions to the 36-month rule from 5
years to 2 years. The commenters
believed that 2 years was sufficient.
Response: We agree, and have revised
this final rule accordingly.
Comment: Several commenters stated
that an ownership change resulting from
estate planning should be exempt
because it shows a commitment to the
delivery of care.
Response: We believe that the
expansion of § 424.550(b)(2)(i) will
allow a number of bona fide estate
transactions to proceed.
Comment: Several commenters stated
that the ‘‘parent company’’ exception in
§ 424.550(b)(2)(ii) should be revised to
include the parent’s subsidiaries,
including the HHA itself. That is, as we
understood the comment to read, if the
HHA itself is internally restructuring,
this should not trigger the 36-month
rule, regardless of the number of cost
reports the entity has submitted.
Response: We have removed the cost
report submission requirement from
§ 424.550(b)(2)(ii). We note further that
§ 424.550(b)(2)(iii) exempts certain
situations in which the HHA itself is
changing its business structure.
Comment: A commenter
recommended an exception for changes
of ownership involving entities that
share a common corporate ownership.
Response: We are not in a position to
adopt this suggestion for this particular
final rule. Nevertheless, we may
consider it as part of a future
rulemaking effort.
Comment: One commenter stated that
the exception in § 424.550(b)(2)(iii) for a
change in business structure should
apply if there is no change in the
individual owners, regardless of
whether there is a change in majority
ownership. The commenter further
stated that there should be no qualifiers
on allowing corporate restructurings
where the chain of ownership remains
the same. The experience of the HHA—
which we interpreted to mean, from the
provider’s comment, as the filing of cost
reports for the previous 5 years—has no
bearing on whether the restructuring
changes the day-to-day operations.
Response: If the majority ownership is
not changing, § 424.550(b)(2)(iii) is
inapplicable. However, we have revised
§ 424.550(b)(2)(iii) to state that a change
in business structure—such as a change
either to or from a corporation, a
partnership (general or limited), or an
LLC—does not trigger § 424.550(b)(1) if
there is no change in the owners of the
HHA.
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The cost report submission
requirement specified in proposed
§ 424.550(b)(2)(i) and (ii) was not part of
proposed § 424.550(b)(2)(iii), and we
have not inserted it into the final
version of the latter provision.
Comment: One commenter stated that
further clarification is needed related to
the internal restructuring that qualifies
for the exception.
Response: Though we are uncertain as
to type of clarification the commenter
seeks, we believe that the exceptions in
§ 424.550(b)(2)(ii) and (iii) regarding
internal restructuring, and the revisions
made to the latter, are clear. We note
that several examples of the types of
restructuring impacted by
§ 424.550(b)(2)(iii) are included within
that provision. CMS, however, may in
the future issue further guidance on this
subject as needed.
(3) Miscellaneous Program Safeguard
Comments
The following is a summary of
comments we received on the proposed
rule that do not specifically address the
merits of our proposed changes to the
capitalization provisions and the 36month rule.
Comment: Several commenters
recommended that we provide
education to Medicare contractors
regarding the implementation of any
new provisions related to changes in
ownership.
Response: We agree with these
commenters, and will develop manual
instructions to implement the
provisions of this final rule.
Comment: Several commenters stated
that this portion of the proposed rule is
confusing, contains certain internal
language conflicts, and requires
clarification. Another commenter stated
that further clarification is needed to
determine the rule’s full impact on
HHAs.
Response: Without further
information as to the provisions that are
of concern to these commenters, we are
unable to address these comments.
Comment: One commenter stated that
the proliferation of new for-profit HHAs
is contributing to the fraud, abuse, and
misuse of the HH benefit, and
recommended that CMS impose a
moratorium on the certification of new
HHAs effective immediately. If, the
commenter stated, CMS’s assertion that
there is already adequate access to HH
services is true, then adding further
capacity creates inefficiency in the
system by adding more fixed costs and,
in some situations, provider-induced
demand.
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Response: While we appreciate this
comment, it is outside the scope of this
final rule.
Comment: Another commenter
expressed great concern about the ease
of entry into the HH marketplace and
raised questions as to the qualifications
of certain HHAs that are granted
deemed status. The commenter urged
CMS to use the final rule to suspend all
deemed status certifications and impose
a national ‘‘cooling off period’’ for new
entries to the marketplace. The
commenter suggested that this occur for
a minimum of 18 months following
publication of this final rule.
Response: While we appreciate this
comment, it is outside the scope of this
final rule.
Comment: One commenter stated that
CMS should ensure that the Medicare
contractor completes the processing of
tie-in notices within 21 days of its
receipt of said notice.
Response: This comment is outside
the scope of this final rule.
Comment: One commenter stated that
the proposed changes will limit a health
system’s ability to engage in good
business practices.
Response: Without further
information as to the specific business
practices the commenter refers to, we
are unable to address this comment.
4. Provisions of Final Rule
Based on the public comments, we are
adopting the provisions of the proposed
rule with the following revisions:
• In § 424.502, we have inserted the
word ‘‘months’’ immediately after the
phrase ‘‘during the 36.’’ We have
inserted the term ‘‘direct’’ to clarify that
the definition of majority ownership
only applies to changes in direct
ownership of the HHA. We have also
changed the verbiage ‘‘following the
initial enrollment into the Medicare
program or a change of ownership’’ to
‘‘following the HHA’s initial enrollment
into the Medicare program or the 36
months following the HHA’s most
recent change in majority ownership,’’
so as to more clearly articulate the
definition’s applicability.
• In § 424.550(b)(2)(i), we have
replaced the ‘‘publicly-traded exception’’
with an exception for an existing HHA
that has submitted 2 consecutive years
of Medicare full cost reports. For
purposes of this exception, low
utilization or no utilization cost reports
do not qualify as full cost reports. We
have also inserted the phrase ‘‘or within
36 months after the HHA’s most recent
change in majority ownership,’’ to
ensure consistency with the verbiage in
the definition of ‘‘change in majority
ownership’’ in § 424.502.
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• In § 424.550(b)(2)(ii), we have
eliminated the 5-year period for cost
report submissions.
• In § 424.550(b)(2)(iii), a change in
majority ownership of the HHA will be
exempt from § 424.550(b)(1) if the HHA
is changing its existing business
structure—such as from a corporation, a
partnership (general or limited), or an
LLC to a corporation, a partnership
(general or limited) or an LLC—and the
owners remain the same.
• In § 424.550(b)(2)(iv), the death of
an owner will not trigger
§ 424.550(b)(1).
• In § 489.28(a), we reemphasized
that the HHA must also have available
sufficient initial reserve operating funds
for the 3 month period following the
conveyance of Medicare billing
privileges.
F. Home Health Face-to-Face Encounter
As a condition for payment, the
Affordable Care Act mandates that, prior
to certifying a patient’s eligibility for the
HH benefit, the physician must
document that the physician or a
permitted nonphysician practitioner
(NPP) has had a face-to-face encounter
with the patient. The Affordable Care
Act allows the Secretary to determine a
reasonable timeframe for the encounter
to occur. The certifying physician must
document the face-to-face encounter
regardless of whether the physician
himself or herself or one of the
permitted NPPs perform the face-to-face
encounter. The Affordable Care Act
describes NPPs 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), under the supervision of the
physician.
We proposed a change to the
timeframe of the face-to-face encounter.
The goal of the Affordable Care Act
provision is to achieve greater physician
accountability in certifying a patient’s
eligibility and establishing a patient’s
plan of care. We believe these goals can
be achieved better if the face-to-face
encounter occurs closer to the HH start
of care, increasing the likelihood that
the clinical conditions exhibited by the
patient during the encounter are related
to the primary reason the patient comes
to need HH care. Therefore, we
proposed that the encounter occur
within the 30 days preceding the start
of HH care, if the reason for the
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encounter is related to primary reason
the patient requires home care. If no
such encounter occurred prior to the
start of HH care, we proposed that the
encounter must occur within 2 weeks
after the start of care.
Additionally, as part of the Affordable
Care Act mandated encounter
documentation, we proposed that the
physician document on the certification
how the clinical findings of the
encounter support the eligibility
requirements that a patient be
homebound and need intermittent
skilled nursing or therapy. The
Affordable Care Act allows NPPs to
perform the face-to-face encounter and
inform the certifying physician. We also
proposed that a NPP performing the
face-to-face encounter with a patient
cannot be employed by the HHA
providing care, consistent with current
policy which precludes a physician who
certifies a patient’s HH eligibility from
having a financial relationship with the
HHA.
For a complete description of the
Home Health Face-to-Face Encounter
proposed implementation approach we
refer readers to the CY 2011 HH PPS
proposed rule published on July 23,
2010.
Comment: A number of commenters
stated concern regarding the feasibility
of implementing a face-to-face
encounter requirement and they
suggested that the face-to-face encounter
requirement be removed altogether.
Commenters stated opposition to
implementation of the face-to-face
encounter requirement, fearing that it
would cause agencies to go out of
business and place stress on the
physician-HHA relationship. Another
commenter suggested that the face-toface requirements would also place a
strain on the relationship between
emergency personnel, such as
hospitalists and ER physicians, and
primary care physicians. Additionally,
some commenters stated that the faceto-face encounters could cause
decreased access to physician care
services since the physician would be
inundated performing face-to-face
encounters and would not have enough
time to provide medically-related
services. Furthermore, a commenter
suggested that CMS allow the certifying
physician to decide whether or not a
face-to-face encounter was even needed.
Commenters described the challenges
and health risks associated with
homebound patients visiting a
physician’s office for the face-to-face
encounter, and some patients would
need to be transported via ambulance to
see a physician or NPP for the
encounter. A few commenters stated
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that there should be an audit process
after HH services are provided as an
alternative to implementing face-to-face
encounter requirements. Many
commenters suggested that the face-toface encounter requirements would
delay and decrease access to HH
services, resulting in unnecessary and
prolonged visits to hospitals or
emergency care settings, which
ultimately increase Medicare costs.
Commenters also described the burden
and additional costs, which agencies
will incur as a result of this
requirement, with many commenters
stating that the requirement will risk
access to HH care for Medicare
beneficiaries. A commenter asked CMS
to explain the rationale behind the
requirement for a face-to-face encounter
and of HH care. Another commenter
asked CMS to clarify whether the faceto-face encounter would be required
solely for the first episode or also for
consecutive episodes.
Response: We note that section
6407(a) of the Affordable Care Act (as
amended by section 10605) amends the
requirements for physician certification
of HH services by requiring that, prior
to making such certification, the
physician must document that the
physician himself or herself or specified
NPP has had a face-to-face encounter
with the patient. The legislation
mandates the face-to-face encounter as a
condition for payment. We are required
by law to implement this provision and
we do not have the authority to waive
the requirement or to adopt alternatives
to it. The provision does provide us
with some flexibility in the
implementation, such as providing us
with the discretion to set a reasonable
timeframe for this encounter.
While we are sensitive to
commenters’ concern regarding care risk
associated with this requirement, we
also note that in enacting this provision,
the Congress allowed practitioners other
than the certifying physician to perform
the encounter. Specifically, the
Affordable Care Act describes NPPs 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, under the
supervision of the physician. The
Affordable Care Act also allows the
encounter to be satisfied through the use
of telehealth services, subject to the
requirements in section 1834(m) of the
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Act. We remind the commenter that a
criterion to be eligible for Medicare’s
HH benefit has always been that the
patient must be under the care of a
physician. In response to the commenter
who requested that we provide a
rationale for the face-to-face encounter,
we reiterate that this is a mandate of the
Affordable Care Act and, because this is
a statutory requirement, we must
require this encounter as a condition of
payment. However, we believe that
more physician and/or practitioner
involvement with the HH patient will
improve the quality of care provided to
the HH patient by providing the
physician, who is managing the care
plan, with more direct clinical
information about the patient which is
obtained from the encounter. If a NPP
performed the encounter, the NPP
would communicate the patient’s
clinical information obtained during the
encounter to the certifying physician.
We also believe increased physician
involvement will enable the certifying
physician to more accurately certify the
‘‘homebound’’ and ‘‘in need of skilled
services’’ eligibility requirements, thus
promoting more appropriate use of
Medicare’s HH benefit.
In response to the commenter who
asked CMS to clarify whether the
encounter is required only for the first
episode, we believe that the commenter
is asking whether the provision applies
to the initial certification or whether it
also applies to each subsequent
recertification as well. We note that the
Congress enacted the requirement to
apply to the physician’s certification,
not the recertification. Therefore, we
have interpreted this provision to apply
to the initial certification only. In
response to the commenter’s concern
about transporting homebound patients
to see a physician in order to meet the
requirement, we remind the commenter
that we are allowing an encounter
which occurred prior to home health
admission to satisfy the requirement,
with certain caveats, as we describe in
more detail in the following response.
Also in response to the burden
concerns, we refer commenters to a
2001 survey by the OIG which reported
that of the physicians in the study
sample, 86 percent who sign home
health orders see their patients under
home health care at least monthly. (The
Physician’s Role in Medicare Home
Health (OIG publication No. OEI–02–
00–00620)).
Comment: Some commenters
expressed concern about the proposed
certification timing requirements,
stating that the proposed requirements
may prevent patients from receiving
necessary HH services due to the
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inability to have a face-to-face encounter
in the required timeframe. The time
requirement may not be met due to the
shortage of certifying physicians and
their limited availability and/or the
patients’ limited transportation options,
especially for homebound patients and
those who live in rural areas. A
commenter also suggested that patients
with dementia or behavioral health
conditions may have a particularly
difficult time meeting the face-to-face
requirements. A few commenters
described a survey of HHAs which
suggested that the proposed timeframe
will decrease access to care and cause
delays. In order to prevent delays or
decreased access to HH care,
commenters suggested increasing the
timeframe in which a face-to-face
encounter must occur. Several
commenters believed that if physicians
have seen the patient within the last 6
months, then that visit should satisfy
the encounter requirement. Some
commenters stated that the Congress
intended that the face-to-face encounter
could occur up to 6 months prior to the
initiation of HH services up to and
including the date the physician signs
the certification. Other commenters
suggested other timeframes, such as 90
days prior to the start of care and up to
one month after the start of care.
A commenter suggested that CMS
start with a long timeframe for the faceto-face encounter requirement and then
slowly transition to a shorter timeframe
to better address any unforeseen issues
and ease the transition associated with
this requirement.
One commenter believed there should
be stricter requirements for the face-toface encounter. Two commenters
suggested that CMS remove the
provision, which allows a face-to-face
encounter to be performed after the start
of services. One of the two commenters
further stated that the reason for the
face-to-face encounter requirement is to
ensure that the there is an independent
evaluation of the need for HH services
before they are provided. Allowing
services to be provided before this
assessment is made may cause
confusion if the face-to-face
requirements cannot be met, potentially
causing a sudden termination of
services and a lack of payment for the
services already provided. The
commenter stated that CMS can prevent
these scenarios by requiring that a faceto-face encounter occur before the start
of HH services. The commenter also
stated that the 30-day timeframe
proposed in the face-to-face encounter
requirements was appropriate for
patients who were discharged from the
hospital or emergency room. However,
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the commenter thought that the 30-day
timeframe should be shortened to 15
days for patients who are admitted to
the HH setting from the community. The
commenters suggested that CMS may
want to consider an extended timeframe
for the encounter in rural settings.
Another commenter believed that the
face-to-face requirements be altered or
completely removed in rural areas.
Other commenters urged CMS to
abandon the proposed requirement
which states that the encounter must be
related to the reason the patient needs
home care, describing concerns with
enforcement of such a provision.
Commenters have suggested that when
a patient’s condition changes,
communication between the certifying
physician and the HHA is sufficient and
can replace the need for a more current
face-to-face encounter.
A commenter asked CMS how it
would ensure that there was, in fact, a
face-to-face encounter within the
timeframe.
Other commenters stated that there
may be scenarios where patients are
seen by specialists who do not act as
their certifying physician. In this case,
a primary care physician would need to
perform a face-to-face encounter;
however, the encounter could be
redundant since the patient was already
seen by the specialist. Similarly, another
commenter stated that often patients
will be referred to HH services by
resident physicians or hospitalists and
they may not be able to see a primary
care physician for the face-to-face
encounter. In addition, while the patient
is in the hospital or emergency care
setting, the primary care physician may
not have hospital privileges and may
not be allowed to see the patient.
Furthermore, commenters have stated
that even if hospitalists and emergency
room physicians are allowed to certify
the face-to-face encounter, they may be
hesitant to do so since they would not
want to or be able to take over the plan
of care responsibilities. A commenter
suggested that the primary care
physicians be allowed to certify HH
services after reading the hospitalist’s
discharge summary. Also, a commenter
stated that there already are problems
with delays in starting HH services due
to patients’ lack of follow-up visits or
infrequent visits with their primary care
physician. Other commenters have
stated that some patients do not have a
primary care physician and may need to
be treated by a community-based or
clinic physician, which may take longer
than 14 days to have the face-to-face
encounter. Moreover, commenters
expressed concern with a timeframe of
2 weeks after the start of care to have the
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face-to-face encounter, stating that,
should a timely encounter not occur, the
HHA would then lose money for
services provided during that time and
the patient would not receive all of the
necessary services. The HHA would be
held financially liable when the patients
or physicians are at fault. A few
commenters asked whether an agency
could require patients to sign an
Advanced Beneficiary Notification
(ABN), which would allow the agency
to hold the patient financially
responsible if a face-to-face encounter
did not occur as required. Commenters
expressed concerns where a patient
might not be able to secure an
appointment or obtain transportation
within the 2-week timeframe or who
may be physically unable to get to the
doctor’s office. Another commenter
suggested that there be an exception
provision to the timeframe requirements
if there was sufficient documentation
that showed that there was a reasonable
attempt to schedule a face-to-face
encounter with a physician. A
commenter also asked CMS to clarify
whether partial payment would apply if
the encounter occurred, but did not
occur during the required timeframe.
Some commenters thought that a
hospitalist’s or specialist’s face-to-face
encounter could serve as the certifying
encounter. Other commenters also
thought that the hospitalist or specialist
could sign the plan of care.
Additionally, commenters suggested
that the physician who has the best
understanding of the patient’s condition
should serve as the certifying physician
and a primary care physician can then
formulate and sign the plan of care and
take over responsibility for further care.
Alternatively, a commenter proposed
that the ‘‘HHA medical director’’ be
allowed to act as the certifying
physician in the face-to-face encounter
or the HHAs hire physicians to perform
the face-to-face encounter. Another
commenter asked if and how a part-time
HHA medical director could serve as a
primary care certifying physician.
Furthermore, a commenter suggested
that a HHA employee find out the
patient’s last face-to-face physician
encounter and document the date. If the
date was within 6 months of the HH
referral, then the patient could receive
HH services. If the patient had not seen
a physician in 6 months, the commenter
proposed that the patient see a
physician before he or she could be
enrolled in HH care services. The
commenter also recommended that the
date of the face-to-face encounter be
placed on the plan of care.
A commenter also thought that the
same timing standards currently used
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for certification be applied to the faceto-face encounter certification.
Response: In the proposed rule, we
proposed that the encounter occur
within the 30 days preceding the start
of HH care, if the reason for the
encounter is related to the primary
reason the patient requires home care. If
no such encounter occurred prior to the
start of HH care, we proposed that the
encounter must occur within 2 weeks
after the start of care. We believe that
this timeframe increases the likelihood
that the clinical conditions exhibited by
the patient during the encounter are
related to the primary reason the patient
comes to need HH care. We also believe
that this timeframe best meets the
program integrity and quality goals
associated with the provision. The
timeframe ensures that the certifying
physician can accurately determine
whether the patient meets the
homebound and skilled need eligibility
criteria while also ensuring that the
physician understands the current
clinical needs of the patient to establish
an effective care plan. Additionally, a
recent study shows that physician
involvement with the HH patient within
30 days prior to HH admission results
in significantly better patient outcomes.
Patients receiving a face-to-face
physician visit within 30 days of HH
care were 1.45 times more likely to be
discharged without hospitalization than
patients who did not receive a face-toface physician visit during their episode
of care (Wolff et al., 2009, p. 1151 1). We
incorporated studies such as this one
and our clinical judgment in the
creation and formation of the proposed
timeframe. However, we found some of
the commenters’ concerns compelling.
Regarding the feasibility of the proposed
timeframes and the corresponding
access to care risks, especially in rural
areas, we will revise the timeframes
described in the proposed rule to allow
the encounter to occur up to 90 days
prior to the start of care, if the reason
for the encounter is related to the reason
the patient comes to need HH care. If no
such encounter has occurred, we will
allow the encounter to occur up to 30
days after the start of care. This
alternative timeframe was
recommended in comments submitted
by a major association of home care
physicians. The comments described
that chronic illnesses among the elderly
are commonly associated with an office
visit every 3 months, and by adopting a
timeframe where the encounter could
1 Wolff, J. L., Meadow, A., Boyd, C. M., Weiss, C.
O., & Leff, B. (2009). Physician evaluation and
management of Medicare home health patients.
Medical Care. 47(11), 1147–1155.
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occur up to 3 months prior to the start
of care, we would significantly mitigate
the access to care risk. For those
patients who had no encounter during
the 3 months prior to the start of care
which was related to the reason the
patient comes to need HH care, we will
allow the encounter to occur up to 30
days after the start of care. We continue
to believe that it is essential for the
encounter to be related to the reason the
patient comes to need home care.
Otherwise, the encounter does not meet
what we believe to be the goals of the
provision—to enable more appropriate
use of the benefit while also improving
the physician’s ability to manage the
patient’s care. However, we understand
the commenters’ concerns surrounding
enforcement of this provision. It is not
our intent that those who enforce the
provision would take such a literal
interpretation to look for a cause and
effect relationship between a diagnosis
on the physician’s claim and the
diagnosis on the HH claim. Instead, it is
our intent that should a patient’s
clinical condition change significantly
between the time of the encounter and
the start of home health care such that
the physician’s or NPP’s ability to
accurately assess eligibility and care
plan would be at risk, a more current
encounter would be necessary in order
to meet the goals of the statutory
requirement. As such, to address the
commenters’ concerns, we will expand
on this requirement in manual guidance
which we believe is the appropriate
venue for such clarification.
We disagree with the commenters
who stated that the Congress intended
for us to allow the face-to-face
encounter timeframe to encompass the 6
months prior to the date on which the
physician signs the certification. If this
was the Congress’s intent, the legislative
provision would not have included
specific language, ‘‘reasonable timeframe
as determined by the Secretary,’’ which
allows the Secretary to determine the
timeframe.
We disagree with the commenter who
suggested that the encounter must occur
prior to the start of care. We believe that
it will not be uncommon that a patient
needs home care but has not seen a
physician in the 3 months prior to the
start of care and this should not
preclude access. As is the practice
today, the HHA would be responsible
for ensuring that services are provided
to eligible patients, and the face-to-face
encounter, associated documentation,
and signing of the certification would
occur after the start of care.
In response to the commenters who
believe that we should abandon the
proposed criterion that the encounter
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has to be related to the reason the
patient has come to need HH, we
continue to believe that in order to
achieve what we believe to be the goals
of the provision, the encounter must
occur close enough to the HH 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
HH care. It ensures that the certifying
physician can accurately determine
whether the patient meets the
homebound and skilled need eligibility
criteria while also ensuring that the
physician understands the current
clinical needs of the patient to establish
an effective care plan.
In response to the commenter who
wanted to know how we would ensure
that there was, in fact, a face-to-face
encounter within the timeframe, we will
issue instructions to the contractors who
perform medical reviews to ensure
compliance with this regulation. We
also expect that other program integrity
oversight efforts will be effective
vehicles to monitor compliance with
this condition of payment. We also
expect that surveyors will monitor
compliance with this requirement. In
response to the commenter who asked
that we clarify whether partial payment
would apply if the encounter occurred
outside the required timeframe, we
reply that the Affordable Care Act
established this provision as a condition
of payment and therefore we would
have no statutory authority to partially
pay an agency if they complied with
some but not all of the provision.
To address the commenters’ concerns
surrounding which physician must
perform the face-to-face encounter and
document that the face-to-face
encounter occurred, we remind the
commenter that the Affordable Care Act
requires the certifying physician to
document that the physician himself or
herself or specified NPP has had a faceto-face encounter (including through the
use of telehealth, subject to the
requirements in section 1834(m) of the
Act) with the patient. The Affordable
Care Act describes NPPs 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, 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.
Where the patient is admitted to HH
from the hospital, we believe that
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current practice associated with the HH
certification would apply to the face-toface encounter as well. In most cases,
we would expect the same physician to
refer the patient to HH, order the HH
services, certify the beneficiary’s
eligibility to receive Medicare HH
services, and sign the plan of care. It
would be this physician who would be
responsible for documenting on the
certification that he or she, or a
specified NPP working in collaboration
with the certifying physician, had a
face-to-face encounter with the patient.
However, we recognize that, in certain
scenarios, one physician performing all
of these functions may not always be
feasible. An example of such a scenario
would be a patient who is admitted to
HH upon hospital discharge. While we
would still expect that in most cases, a
patient’s primary care physician would
be the physician who refers and orders
HH services, documents the face-to-face
encounter, certifies eligibility, and signs
the plan of care, there are valid
circumstances when this is not feasible
for the post-acute patient. For example,
as several commenters pointed out,
some post-acute HH patients have no
primary care physician. In other cases,
the hospital physician assumes primary
responsibility for the patient’s care
during the acute stay, and may (or may
not) follow the patient for a period of
time post-acute. In circumstances such
as these, it is not uncommon practice for
the hospital physician to refer a patient
to HH, initiate orders and a plan of care,
and certify the patient’s eligibility for
HH services. In the patient’s hospital
discharge plan, we would expect the
hospital physician to describe the
community physician who would be
assuming primary care responsibility for
the patient upon discharge. It would be
appropriate for the physician who
assumes responsibility for the patient
post-acute to sign the plan of care and
thus be considered ‘‘under the care’’ of
that community/personal physician
throughout the time the patient is
receiving HH services. In a scenario
such as this, if the hospital physician
certifies the patient’s HH eligibility and
initiates the orders for services, the
hospital physician could document that
a face-to-face encounter occurred and
how the findings of that encounter,
which in this scenario would have
occurred during the patient’s acute stay,
support HH eligibility. The community
physician designated on the discharge
plan would assume responsibility for
the patient at some point after acute
discharge, updating orders, signing the
plan of care, etc.
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It is important to reiterate that to be
eligible for Medicare’s HH benefit, the
patient must be under the care of a
physician, and it is ultimately the
responsibility of the HHA that this
criterion is met. We have always held
the HHA responsible for ensuring that
there is a physician-signed plan of care,
physician-signed orders, and a
physician-signed certification.
Therefore, we will also hold the
agencies responsible for the certifying
physician’s encounter documentation.
By statute, this documentation is a
requirement for payment just as a
physician-signed certification of
eligibility is a requirement for payment.
As such, the requirements for the faceto-face encounter documentation have
many similarities to the existing
certification requirements. We have no
flexibility to adopt exceptions to the
statutory face-to-face documentation
requirements.
In response to the commenters who
suggested that they deliver an HHABN
to the HH patient describing the
patient’s possible financial liability
should the face-to-face encounter not
occur as required, this practice is not
permitted. The HHABN, Form CMS–R–
296, has been approved by the Office of
Management and Budget (OMB) to
provide limitation of liability
protections to Original Medicare
beneficiaries receiving HH services
under section 1862(a)(1)(A)of the Act for
care that CMS or its contractors
determines is not reasonable and
necessary under Medicare; section
1862(a)(9) for custodial care; (g)(1)(A)
for care when the beneficiary is not
homebound; and section 1862(g)(1)(B)
for care provided to a beneficiary who
is not in need of skilled nursing care.
The HHABN must not be used to
transfer liability to the beneficiary when
technical requirements for payment,
such as a face-to-face encounter, are not
met. The HHABN is not approved for
this use.
In response to the commenters who
requested that HHA medical directors
act as the certifying physician in the
face-to-face encounter or that the HHAs
hire physicians to perform the face-toface encounter, we remind the
commenters of longstanding regulatory
prohibitions in § 424.22 which impose
financial restrictions on the relationship
between the HHA and the certifying
physician. We continue to believe that
these financial restrictions strengthen
the integrity of the benefit.
Comment: Commenters have also
expressed concern about the
requirement that the face-to-face
encounter be related to the reason the
patient needs HH services and concern
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about the documentation and
rationalization requirements.
Commenters also stated that the HHA
has no control over the quality of the
physician’s documentation and no
method to enforce proper physician
documentation. A commenter suggested
that the increased documentation
responsibilities placed on the primary
care physician would result in fewer
referrals to HH. The commenter also
stated that since the HHAs have no
control over the quality of a physician’s
documentation, there should be a
‘‘without fault’’ provision applied when
there is proper certification but lack of
proper documentation. Furthermore,
another commenter stated that it will be
extremely costly for agencies to change
their documentation systems to ensure
the face-to-face encounter
documentation is sufficient. Moreover,
the commenter stated that there should
be payment guarantees so that HHAs are
not penalized because of improper
physician documentation. A commenter
suggested that CMS not finalize the
proposed requirement that the
physician’s own medical record
documentation be consistent with the
encounter documentation on the
certification. Another commenter
suggested that CMS should not
withhold payment for failing to meet the
encounter documentation and instead
impose other sanctions. One commenter
also suggested that CMS provide
payment even when a face-to-face
encounter does not occur if the HHA
can show that it informed patients and
physicians of the requirements. In
addition, a commenter suggested that
agencies be protected from potential
patient complaints that may be a byproduct of these requirements. Another
commenter suggested that CMS should
not withhold payment for failing to
meet the encounter documentation and
instead impose other sanctions. Some
commenters have suggested a gradual
implementation of the new face-to-face
requirements, or delaying the
implementation of the new face-to-face
encounter requirements. Commenters
stated that the face-to-face encounter
documentation requirements will slow
the HHAs’ efforts to move to electronic
health records. Commenters have also
stated that there are language barriers
with communicating the new face-toface encounter requirements. Other
commenters requested that CMS permit
HHAs to include standardized language
on the certification form which would
be signed and dated by the certifying
physician to suffice as the encounter
documentation. Commenters asked CMS
to educate physicians and beneficiaries
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about the new face-to-face requirements,
the rationale for the requirements, and
their responsibility in these
requirements.
Response: We thank the commenters
for their suggestions. Regarding the
comment, which suggested that we
permit HHAs to include standardized
face-to-face encounter language on the
certification form, which would be
signed and dated by the certifying
physician, we remind the commenter
that the statutory language in the
Affordable Care Act requires that prior
to certifying, the physician must
document that the face-to-face
encounter occurred. The law requires
this as a condition for HH payment. We
proposed that the documentation of the
encounter be a separate and distinct
section of, or an addendum to, the
certification, and that the
documentation include why the clinical
findings of the encounter support HH
eligibility. We believe that our proposed
documentation requirements meet the
Congress’ intent for more physician
involvement in determining the
patient’s eligibility and managing the
care plan. We believe that were we to
allow the HHA to craft standard
language which the physician would
then simply sign, we would not achieve
the sort of physician involvement in the
eligibility determination and care plan
which was the Congress’ intent. As
such, we believe that if a HHA were to
develop standardized encounter
language to be signed by the physician,
they would not be adhering to the
statutory payment requirements that the
‘‘physician document’’ the encounter.
Similarly, regarding the comment that
we should not withhold payment, or
should consider imposing other nonpayment sanctions, or hold the HHA
‘‘without fault’’ for failing to meet the
encounter documentation requirement,
we reiterate that the law requires the
physician to document that the face-toface encounter occurred prior to
certifying HH eligibility, as a condition
of payment. Under section 6407(b) of
the Affordable Care Act, we have no
legal authority to exempt a HHA from
this requirement, or to impose alternate
sanctions if a HHA fails to meet a
statutory payment condition.
Regarding the commenter who
requested that we should not require the
physician’s own medical record
documentation to be consistent with the
documentation on the certification, we
understand the commenter’s concern,
and we will revise the proposed
regulation text to make clear that we are
not holding the HHA responsible for the
physician’s own medical record
documentation associated with the
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70431
encounter. We would expect that a
physician who performs a medically
necessary physician service, which also
satisfies the face-to-face encounter
requirement, would maintain medical
record documentation concerning the
encounter, and the clinical findings
associated with that encounter would be
consistent with the physician’s
certification documentation. However, it
is not our intent to penalize the HHA if
the physician’s own medical record
documentation associated with the
encounter is not in good order. Rather,
we would look to the physician to fulfill
his or her responsibility for ensuring
appropriate medical record
documentation associated with the
encounter, and any associated Medicare
billing. Regarding the commenter who
asked us to protect agencies from
complaints, which may be associated
with this provision, we are unsure what
the commenter means. We will continue
to require providers to adhere to quality
care practices while adhering to
Medicare’s Conditions of Participation.
We concur with the commenter who
suggests that we educate physicians
regarding this new law, and will do so
via open door forums, listserv
announcements, and MedLearn articles.
Regarding the comments which
requested that we delay the face-to-face
requirements, the comment that the
face-to-face encounter documentation
requirements will slow the HHAs’
efforts to move to electronic health
records, and the comments that
suggested there are language barriers
with communicating the new face-toface encounter requirement, we again
reiterate that this is a statutory
requirement, which we must
implement. We do not understand the
rationale behind the commenter’s fear
that this requirement would delay
adoption of electronic health records.
We suspect this commenter is
concerned that agency resources which
might have been directed toward
adopting electronic health records
would be re-directed to implement this
provision. We again reiterate that this is
a statutory requirement, which we are
required to implement.
We are also confused why the
commenter believes that language
barriers would preclude the face-to-face
encounter, and remind the commenter
that being under the care of a physician
is a longstanding eligibility requirement
for the HH benefit.
Comment: Commenters stated
concern regarding the requirements for
a face-to-face encounter by telehealth,
stating that the current qualifications for
telehealth coverage should not apply to
the face-to-face encounter by telehealth
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and that CMS has overly strict
requirements on the parameters for a
face-to-face encounter by telehealth. The
current qualifications require the patient
to go to an ‘‘originating site’’ outside of
their home; however, by doing so, the
patient’s homebound status and
therefore eligibility for HH services may
be questioned. The commenter
requested that CMS use section 1834(m)
of the Act solely to define telehealth and
expand the definition of telehealth
services to allow for the use of
equipment in the patient’s home. Some
commenters suggested that the face-toface encounter by telehealth can be
satisfied via telephone calls from the
physician to the patient. Other
comments suggested that CMS allow
face-to-face telehealth visits at the
patient’s home and that the use of
technology, such as video chat and
remote assessment devices, be allowed
in the telehealth visits.
Response: There are several codes that
are currently defined as Medicare
telehealth services that could be used to
furnish and bill for medically necessary
physician services, which would satisfy
the encounter requirement, if furnished
by telehealth. However, section 1834(m)
requires the patient to be located at one
of several specified types of originating
sites, and we have no flexibility to
permit telehealth services to be
furnished to a patient in the home.
Regarding the comment that a
patient’s visit to a physician’s office or
telehealth originating site would
threaten the patient’s homebound
status, we note that longstanding policy
describes that if a patient leaves the
home for health care treatment, the
patient would nevertheless be
considered homebound.
Comment: Several commenters stated
concern regarding the proposed
restriction that NPPs who are employed
by the HHA cannot perform the face-toface encounter. Commenters state that
the proposed regulation imposes stricter
financial criteria on the relationship
between the HHA and NPPs who are
performing the face-to-face encounter
than has previously been applied to
physicians who certify HH eligibility.
Commenters stated that by having the
same financial relationship criteria for
certifying physicians and NPPs
performing a face-to-face encounter,
CMS will minimize conflict of interest
while maximizing the number of
medical personnel who are qualified to
perform the face-to-face encounter.
Other commenters believe that HHA
NPPs should be allowed to perform the
face-to-face encounter, noting that the
increase in integrated health systems
and associated efficiencies in providing
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care would justify allowing the
practitioner to be an employee of the
HHA. Several commenters also
requested that NPPs be allowed to
certify HH eligibility.
Response: We believe that given the
HH program integrity concerns in
certain pockets of the country
surrounding the certification of HH
eligibility, it is imperative that NPPs be
subject to the same financial limitations
with the HHA as currently apply to the
certifying physician. We agree with the
commenters that the NPPs should not be
subject to harsher financial limitations
with the HHA than the certifying
physician and we have revised the
proposed § 424.22 accordingly. In
response to the commenter who
requested that NPPs be allowed to
certify HH eligibility, we remind the
commenter that sections 1814(a)(2)(C)
and 1835(a)(2)(A) of the Act prohibit
this.
Comment: Commenters expressed
concern about the requirements for a
physician signature and date on the
encounter certification, stating that
often physicians will not date
documents. Commenters stated
opposition to the requirement for a date
from the physician, stating that this
requirement would cause unnecessary
burdens as the agency could frequently
be resending certifications back to
physicians to obtain the date.
Commenters stated that since CMS has
previously allowed the agency to date
the certification based on the receipt
date for other documents, CMS should
apply the same policy to the encounter
certification date. One commenter
explicitly stated that the receipt date is
adequate proof that the agency received
the required documentation before
billing for the HH services.
Response: The requirement that a
physician date the certification reflects
longstanding manual guidance. As such,
this is existing policy. We are taking this
opportunity to codify this in regulation
for clarification.
Comment: Some commenters
suggested that CMS increase the
reimbursement associated with the
current billing code (G0180) which
physicians use when billing for their
services associated with Medicare HH
certification. Other commenters
questioned whether the face-to-face
encounter visits would be separately
reimbursed by Medicare. Commenters
wanted CMS to clarify whether the
certification will be billed separately
from the face-to-face encounter.
Furthermore, the commenters wondered
what the pay codes would be for the
face-to-face encounter and suggested
that there would be delayed RAP
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payment to agencies since agencies
would need to wait until the proper
certification and documentation were
collected in order to receive payment.
Another point commenters brought up
was that residents may have more than
one residence and therefore they may
need more than one certifying
physician, further burdening patients
who require HH services. Also,
commenters stated that by requiring the
face-to-face encounter, the patient must
pay an additional twenty percent
copayment for the physician visit,
which may be costly, particularly for
those patients who were recently
discharged from the hospital and were
required to pay their Medicare hospital
deductible as well. Commenters brought
up the example that a patient may not
want to have a face-to-face encounter
with a physician when there is no
medical reason for the visit. Moreover,
a commenter proposed that CMS
continue to pay RAPs through its
current method; however, CMS should
change the payment of the final claims
based on the signed certification.
Response: It is our intention to allow
RAP payments as we currently do today
while the HHA is awaiting physician
completion of the certification. If the
face-to-face encounter included
medically-necessary covered physician
services to the HH patient, the physician
could bill Medicare for these covered
services under the physician fee
schedule. Regarding the physician
billing practices associated G0180, we
see no need to change those
requirements or the associated
reimbursement. Regarding the post
acute patient co-pay concern, we refer
the commenter to the response to the
comment above which describes the
role of the hospitalist in the face-to-face
encounter. Regarding the broader
copayment comment, we again remind
the commenter that a HH patient must
be under the care of a physician as an
eligibility requirement, and therefore
would expect that regular physician
visits to occur during the HH course of
treatment. As such, we do not believe
that a face-to-face encounter would
impose a new copayment financial
burden on the patient.
Comment: Some commenters were
supportive of our proposal to allow
NPPs to have the face-to-face encounter.
Commenters also agreed that employees
of the HHA should not be allowed to do
the face-to-face encounter. The
commenters also agreed with the faceto-face encounter requirements and the
documentation requirements and that
the encounter requirements should be
able to be fulfilled through the use of
telehealth.
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Response: We thank the commenters
for their support.
Comment: Some commenters
expressed concern that the face-to-face
encounter requirement would bring into
question a patient’s right to refuse a
clinical visit for care that is for
regulatory compliance only and not
medically necessary.
Response: We again remind the
commenters that this is a mandate of the
Affordable Care Act and, because this is
a statutory requirement, we must
require this encounter as a condition of
payment. We would expect that
practitioners would typically be
conducting a medically necessary
service to the patient, and this service
would also meet the face-to-face
encounter requirement. We disagree
with the commenters that such
encounters satisfy a regulatory
requirement only. We refer again to the
research,2 which shows that physician
visits result in better HH patient
outcomes. Finally, we also remind the
commenters that, in order to be eligible
for the Medicare HH benefit, a patient
must be under the care of a physician.
Should a patient refuse to have a faceto-face encounter with the physician
responsible for care, CMS would
question whether the patient was
legitimately under the care of the
physician.
We thank the commenters for their
insightful comments. In summary, we
will finalize the proposed
implementation approach with the
following exceptions:
We will revise the timeframes
described in the proposed rule to allow
the encounter to occur up to 90 days
prior to the start of care, if the reason
for the encounter is related to the reason
the patient comes to need home health
care. If no such encounter has occurred,
we will allow the encounter to occur up
to 30 days after the start of care. We will
also revise the proposed regulation to re
move the requirements concerning the
physician’s own medical record
documentation. We will also revise the
regulation text to impose the same
financial restrictions with the HHA to
nonphysician practitioners who perform
the face-to-face encounter as currently
apply to certifying physicians.
G. Future Plans to Group HH PPS
Claims Centrally During Claims
Processing
Generally speaking, Medicare makes
payment under the HH PPS on the basis
2 Wolff, J.L., Meadow, A., Boyd, C.M., Weiss,
C.O., & Leff, B. (2009). Physician evaluation and
management of Medicare home health patients.
Medical Care. 47 (11), 1147–1155.
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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
services from the six HH disciplines
(skilled nursing, HH aide, physical
therapy, speech language pathology,
occupational therapy, and medical
social services) and nonroutine medical
supplies. Durable medical equipment
covered under HH is paid for outside
the HH PPS payment. To adjust for casemix, 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, 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}); 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 the assigned HIPPS code on
the Medicare HH PPS bill, ultimately
enabling our claims processing system
to reimburse the HHA for services
provided to patients receiving
Medicare’s HH benefit.
Additionally, the HHA is separately
required to electronically submit OASIS
assessments for their Medicare and
Medicaid patients to CMS via their state
agency. On the HH PPS Web site at
https://www.cms.gov/homehealthpps/
01_overview.asp, we provide 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
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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 we provide.
In 2008, we deployed the first
refinements to the HH PPS since its
inception in 2000. Prior to the 2008
refinements, we made infrequent, minor
changes to the HH PPS grouper
software. Effective with the refinements,
the HH PPS grouper became more
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.
In addition, since the 2008
refinements were implemented, we have
identified a significant increase in
OASIS assessments submitted with
erroneous HIPPS codes. These errors
occur when HHAs 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. We inform HHAs if 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
the U.S. health care industry
permanently transitions from ICD–9 to
ICD–10 for medical diagnosis and
procedure coding in October 2013,
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 an option, which
would enable us to assign HIPPS codes
to the HH PPS bills during claims
processing. If we are successful in
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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 for HIPPS codes
on bills, decrease costs, and burden to
HHAs, and 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 CMS to consider this
option of assigning HIPPS codes to the
HH PPS bills during claims processing.
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 50 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, thus potentially
enabling the HIPPS code to be
computed during claims processing.
However, a major challenge exists
with the feasibility of computing the HH
PPS group during claims processing is
the awarding of case-mix points for
reported primary and secondary
diagnoses. 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
CMS 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.
We currently instruct 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 https://
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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 problem, we
are analyzing options to map diagnoses
currently reported in M1024 (formerly
M0246) to diagnoses that are reportable
as primary and secondary diagnoses in
the HH 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 HH
setting. However, additional analysis
and mapping are needed to fully resolve
this challenge.
We solicited public comments on the
potential enhancement described above
to assign the HIPPS code to the HH PPS
bill during claim processing. This
enhancement would require HHAs to
report all the OASIS items necessary to
group the episode on the HH PPS bill.
As stated above, reporting on OASIS
items on the bill 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.
The following is summary of the
comments we received regarding the
proposal to group HH PPS claims
centrally.
Comment: Several commenters stated
their support of our proposal to
centralize grouping of HH PPS claims as
long as the HH grouper continued to
remain available for HHAs and their
vendors.
Response: We recognize that HHAs
and their vendors will continue to have
a need for the HH grouper software.
Therefore, we do not have any plans to
discontinue this process should we
decide to implement the grouping of HH
PPS claims during claims processing.
Comment: One commenter suggested
that we anticipate and plan to develop
the appropriate claim response for
claims that contain data errors that
prevent the calculation of a HIPPS code.
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Response: We appreciate this
feedback and will be sure to address this
concern should we decide to move
forward with this proposal. We will
note that currently our claims
processing system has specifications
that define valid values for each field.
The necessary guidance would be
provided to HHAs and their vendors for
implementation of this requirement.
Comment: One commenter stated that
our proposal does not specify the effect
of this proposed change on the current
Resident Assessment Protocol (RAP)
and final claim processing timelines.
Response: The proposal to group HH
PPS claims centrally during claims
processing has no effect on the RAP or
final claims processing timelines. In
fact, the RAP is not utilized in the HH
setting. In terms of the final claims
processing timelines, the long standing
guidelines for our contractors will
continue to apply. The guidance can be
accessed at https://www.cms.gov/
manuals/downloads/clm104c01.pdf
through the Internet only manual, IOM
100–4 Chapter 1 Section 80.2.1.
Comment: Several commenters stated
that while we identified a concern
regarding the increased number of errors
in HIPPS codes submitted, we did not
acknowledge errors identified by HHAs
and their vendors in the HHRG released
by us.
Response: Beginning in 2010, we put
into place a mechanism for our
contractor that developed the HHRG
software for CMS to beta test any
updates to the software with interested
parties. All issues noted during beta
testing are to be addressed by our
contractor prior to final release of an
updated HHRG. Our aim is to permit
proper vetting of any grouper such that
we can avoid errors within our HHRG
in the future.
Comment: One commenter stated that
grouping HH PPS claims centrally
during claims processing does not
reduce burden upon HHAs because the
burden of reporting HIPPS codes is
replaced with one of reporting OASIS
items.
Response: OASIS information
reported on claims under this proposal
would be reported in claims fields
currently used by HHAs; so we do not
believe that requiring a replacement of
data in current fields represents an
additional burden.
Comment: Several commenters stated
that our solicitation of comments did
not provide enough detail surrounding
the impact upon accounts receivable
information to provide meaningful
comments. The commenters suggested a
separate Federal Register notice be
issued.
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Response: We appreciate this
feedback and believe that based upon
our plans to continue to provide the
HHRG software, that the concern about
potential impact upon HHA operations
and their accounting needs will be
addressed. In addition, should we
decide to implement this provision in a
future regulation, we will address
additional details through a notice of
proposed rulemaking in which
additional comments can be provided
by HHAs.
Comment: One commenter stated
concern that our future plans to group
HH PPS claims centrally during claims
processing will create a burden on
HHAs and their vendors.
Response: We appreciate this
feedback and believe that since the data
being reported duplicates the
information necessary for OASIS, we are
not creating additional burden for HHAs
and their vendors. In addition, as noted
above, the proposed reporting of this
information would replace other data in
currently used claims fields.
Comment: Several commenters stated
that there are no details surrounding
how the grouper assignment would be
communicated back to the agencies and
on claims.
Response: The HIPPS code that our
claim processing system assigns will be
added to the claim record so that the
provider will be able to view the
assignment upon online look-up. The
HIPPS code assigned will also be
returned on the electronic remittance
advice.
Comment: A commenter asked about
OASIS data corrections identified after
the claim is submitted and how the
corrections process will be handled and
its effect on payment. In addition, the
commenter would like to know whether
HIPPS code will be assigned at the RAP
or on the final claim.
Response: The HIPPS code would be
assigned on both the RAP and the final
claim. If OASIS data corrections caused
the HIPPS code assigned to the episode
to change, the HHA would be able to
cancel and resubmit the RAP for the
episode. This resubmission process to
the RAP presently occurs. HHAs that do
not maintain grouping software for their
internal purposes would have access to
the HIPPS code calculated by the State
OASIS system.
Comment: A commenter asked how
Medicare Advantage (PFFS) payors will
be able to calculate the HHRG in the
future based upon implementation of
this proposal. In addition, the
commenter stated concerns that if the
HHRG software is not made available
that the HHAs will be unable to advise
patients of the copayment amounts.
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Response: We appreciate this
feedback and again want to reassure
HHAs and their vendors that we plan to
continue to make the HHRG software
updates available for use which will
permit the Medicare Advantage plans to
use the HHRG to assist claims
processing. In addition, the HHAs and
their vendors will be able to continue to
advise patients of copayments due.
H. New Requirements Affecting Hospice
Certifications and Recertifications
Section 3132 of the Affordable Care
Act requires hospices to adopt some of
MedPAC’s hospice program eligibility
recertification recommendations,
including a requirement for a hospice
physician or nurse practitioner to have
a face-to-face visit with patients prior to
the 180th-day recertification, and to
attest that such a visit took place. The
Affordable Care Act was enacted too late
in the calendar year for the
implementation proposals relating to
these new requirements to be included
in a Hospice Wage Index Proposed Rule.
Therefore, these proposals were
included in the Home Health
Prospective Payment System Rate
Update for Calendar Year 2011; Changes
in Certification Requirements for Home
Health Agencies and Hospices Proposed
Rule. As such, we are responding to
comments and issuing our
implementation plan in this final rule.
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. MedPAC
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 through
371.)
Section 3132(b) of the Affordable Care
Act requires hospices to adopt
MedPAC’s hospice program eligibility
recertification recommendations.
Specifically, the Affordable Care Act
amends section 1814(a)(7) of the Act to
require that on and after January 1,
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2011, a hospice physician or nurse
practitioner (NP) must have a face-toface 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 Affordable Care Act
requires that the hospice physician or
NP attest that such a visit took place, in
accordance with procedures established
by the Secretary of the HHS. The
Affordable Care Act provision does not
amend the statutory requirement that a
physician must certify and recertify a
patient’s terminal illness. By statute,
only a physician (not a NP) may certify
a patient’s terminal illness, however,
section 3132 (b)(2) of the Affordable
Care Act allows a NP to furnish a faceto-face encounter; in the case where the
NP provides the face-to-face encounter,
the NP would then need to 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
previously received hospice services
(from the admitting hospice or from
another hospice) must consider the
patient’s entire Medicare hospice stay to
determine in which benefit period the
patient is being served, and whether a
face-to-face visit will be required for
recertification.
As required by the Affordable Care
Act, we made several proposals
regarding § 418.22(a)(3), (a)(4), (b)(3),
(b)(4), and (b)(5) in order to implement
this new statutory requirement. We
believe that 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. As such, in
§ 418.22(a)(4), we proposed that hospice
physicians or NPs make these visits no
more than 15 calendar days prior to the
180-day recertification and subsequent
recertifications, and that the visit
findings be used by the certifying
physician to determine continued
eligibility for hospice care. We noted
that this 15-day timeframe also aligns
the timeframe for recertification visits
with the timeframe required for the
comprehensive assessment update, as
specified in our Conditions of
Participation (CoPs) at § 418.54(d). This
timeframe requirement is also consistent
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with the timeframe required for the
review of the plan of care, as specified
in our CoPs at § 418.56(d). We wrote
that 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 earlier, the statute requires
that the face-to-face encounter be used
to determine the patient’s continued
eligibility for hospice services. We
proposed 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.
Accordingly, we added this proposed
requirement to § 418.22(b)(3) as
subparagraph(v).
Because the statute also requires the
hospice physician or NP to attest that
the face-to-face encounter occurred and
by statute only a physician may certify
the terminal illness, at § 418.22(b)(4) we
proposed 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
proposed that the attestation language
be located directly above the physician
or NP signature and date line.
The attestation is a statement from the
certifying physician or from the NP
which attests that he or she had a faceto-face encounter with the patient. If the
face-to-face encounter was provided by
a NP, the attestation should also include
a statement that the clinical findings of
that encounter have been provided to
the certifying physician for use in
determining continued eligibility for
hospice care. We proposed that the
attestation include the name of the
patient visited, the date of the visit, and
that it 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
must be included whether the visit is
made by a NP or a physician. We note
that it is possible that the certifying
hospice physician is the same physician
who made the visit.
As previously mentioned, we
proposed to revise § 418.22 to
incorporate these requirements and we
proposed to add paragraphs (a)(4) and
(b)(4) to implement the requirements for
a face-to-face encounter with long-stay
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hospice patients and the attestation of
that face-to-face encounter.
In requiring a timeframe in which the
face-to-face encounter must occur, for
consistency, we believe it is important
to also 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 does
not address 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 timeframe for the newly legislated
face-to-face encounter for
recertifications, we proposed that both
certifications and recertifications 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 proposed
timeframe also aligns 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. We
believe the new statutory requirements
reflect the Congress’ desire for increased
compliance with Medicare eligibility
and, in order to implement these
provisions, we proposed to revise
§ 418.22(a)(3).
Furthermore, longstanding manual
guidance stipulates that the physician(s)
must sign and date the certification or
recertification. However, the HHS Office
of Inspector General (OIG) recently
found that certifications for some
hospice patients failed to meet Federal
requirements, including the signature
requirement (HHS OIG, ‘‘Medicare
Hospice Care for Beneficiaries in
Nursing Facilities: Compliance with
Medicare Coverage Requirements,
September 2009’’). In keeping with the
Congress’ desire for increased
compliance with Medicare eligibility
criteria, and to achieve consistency with
the 180-day recertification attestation
requirements, we proposed 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 the document.
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Additionally, 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. Hospice patients are allowed two
90-day benefit periods followed by an
unlimited number of 60-day benefit
periods, so every 60-day benefit period
is by definition beyond the 180-day
recertification. Because we do not
currently require that certifications or
recertifications show the dates of the
benefit period to which they apply, we
proposed 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
period dates on the certification would
make it easier for the hospice to identify
those benefit periods which would
require a face-to-face encounter and
would ease enforcement of this new
statutory requirement.
Section 1814(a)(7)(A) of the Act
requires a valid certification or
recertification for Medicare coverage.
Additionally, section 1814(a)(7)(D) of
the Act now also requires a face-to-face
encounter with patients who reach the
180th-day recertification. We proposed
to revise our regulations to require that
the physician’s signature(s), date signed,
and the benefit period dates be included
on the certification or recertification
because we believe this information is
necessary to determine if these
documents are valid, and to ease the
implementation of the new statutory
requirements. We believe these
requirements are consistent with
practices in the hospice industry, and
we do not believe these proposals will
be burdensome to hospices. As such, we
proposed to add § 418.22(b)(5) to
incorporate these signature and date
requirements.
The following is a summary of the
comments we received regarding the
new requirements affecting hospice
certification and recertification
proposals.
Comment: Commenters asked for
clarification of whether 180 days of
hospice care must be provided before
the face-to-face encounter was required,
or whether the face-to-face was required
when a patient enters the 3rd or later
benefit periods. Several commenters
suggested that we clarify the proposal so
that the focus is on benefit periods,
which they believe is consistent with
the intent of the statute and the
regulation, and which is easier to track;
these commenters suggested we change
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the regulatory text to reference election
periods rather than days.
In contrast, other commenters
suggested we reword the proposal so
that an encounter and its accompanying
attestation will be required after 180
days of hospice care and every 60 days
thereafter. The commenters wrote that
basing the encounter timeframe on
benefit periods rather than actual days
of care would result in some patients
requiring visits after only a short time in
hospice, which the commenters believe
was not in keeping with CMS’ intent to
have patients with long lengths of stay
assessed for continued eligibility. A
commenter suggested that those 180
days must be continuous in order to
trigger a face-to-face encounter.
Other commenters wrote that each
new hospice admission should begin as
day 1 for that hospice. One said that
patients with a history of inappropriate
admissions to different hospices should
not cause the appropriate admissions to
hospices to be penalized. Another wrote
that although Medicare hospice is not
fee-for-service, hospices still assume the
risk of enrolling patients with high-cost
medical needs based on the expectation
that other patients will have lower cost
medical needs. This commenter wrote
that if a patient has had a previous
hospice stay, and those days are
counted toward the 180th-day
recertification requirement, payment for
those days was made to another
hospice. The commenter also believes
this invalidates an argument that the
hospice has ‘‘accrued’’ sufficient funds
to cover the additional costs of the
required visits. The commenter
suggested we not consider a patient’s
total hospice history in defining the
180th-day recertification requirement,
but only focus on days of care within
the specific hospice providing care. The
commenter suggested that this would
also eliminate problems related to
accurately tracking time spent in
hospice.
Another commenter wrote that if a
patient had a significant break in
hospice service, CMS should restart the
time clock for the 180th-day
recertification. Several commenters
suggested that we consider each new
terminal diagnosis to restart the clock as
day 1; these commenters were referring
to situations where a patient receives
hospice care for a terminal diagnosis
from which he or she recovers, and later
receives hospice care for a different
terminal diagnosis.
Other commenters asked for
information about how to count the
days when a hospice patient becomes
eligible for Medicare in the midst of a
non-Medicare hospice stay or when the
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patient has previously received hospice
care outside of the Medicare hospice
benefit.
Response: The relevant language in
the Affordable Care Act reads, ‘‘* * * a
hospice physician or nurse practitioner
has a face-to-face encounter with the
individual to determine continued
eligibility of the individual for hospice
care prior to the 180th-day
recertification and each subsequent
recertification * * *’’ The Medicare
statute, as amended by the Affordable
Care Act, does not define the term
‘‘180th-day recertification.’’ For
purposes of this provision, the Medicare
statute also does not specifically address
how the face-to-face encounter
requirement should apply in the
situation in which a beneficiary
completes the first 90-day benefit period
and is recertified for a second 90-day
benefit period but does not receive 90
days of service in the second benefit
period due to (for example) a revocation
in the middle of the benefit period.
In interpreting the statutory term
‘‘180-day recertification,’’ we considered
the statutory scheme and the existing
language used in the statute and in our
regulations, all of which is structured
around the concept of benefit periods
which, by statute, cannot last longer
than a maximum number of days (90
days for the first two and 60 days for
subsequent benefit periods). The fact
that the statute imposes a maximum
number of days per period does not
mean that an individual must receive
hospice services for the maximum
number of days before a statutory
requirement can be imposed on
subsequent benefit periods. For
example, for payment to be made to a
hospice provider with respect to a
beneficiary, section 1814(a)(7) of the Act
requires a certification (and
recertification) at the beginning of each
benefit period, the first two of which
can last as long as 90 days each.
Previously, we have interpreted these
provisions to require a recertification at
the beginning of each subsequent
benefit period, even if the prior benefit
period did not last the maximum
number of days due to, among other
things, the beneficiary’s revocation
under section 1812(d)(2)(B) of the Act.
Thus, the regulatory language at
§ 418.22 requires certifications at the
beginning of benefit periods rather than
requiring certifications after a certain
number of days of service was actually
provided to a beneficiary.
For the foregoing reasons, we are
defining the 180th-day recertification to
be the recertification which occurs at
the start of the 3rd benefit period—that
is, the benefit period following the
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certification for a second, 90-day benefit
period, regardless of whether the
beneficiary received a full 90 days of
service in the second 90-day benefit
period. We note that, as one commenter
wrote, this method of counting the time
will also be easier for hospices to track.
We also believe that the statute
considers the patient’s total hospice
benefit period, rather than starting the
clock at day 1 or period 1 for each new
hospice or for a different terminal
diagnosis. Furthermore, this method of
counting benefit periods is consistent
with how our systems operate when
tracking Medicare hospice beneficiaries.
We agree with the commenter who
wrote that hospices assume the risk of
enrolling patients with high-cost
medical needs based on the expectation
that other patients will have lower cost
medical needs. As such, we believe that
hospices should consider costs of
patient care in the aggregate, and not on
a per-patient basis. Therefore, we did
not argue in the proposed rule that a
hospice ‘‘accrues’’ sufficient funds on a
per-patient basis to cover the cost of the
visit based on a patient having prior
days of care with that hospice.
To illustrate this benefit period
method of counting, if a hospice patient
elected the benefit for the first time on
June 1st, completed the 1st 90 day
period (on August 30th), began the 2nd
90 day period, but revoked 30 days into
the benefit period (on September 29th),
and re-elected hospice the following
January, the beneficiary would be in his
3rd benefit period. The 3rd benefit
period would require a face-to-face visit
at admission even though he had not
received 180 calendar days of care.
The Medicare hospice benefit periods
only apply to Medicare hospice
patients, regardless of whether Medicare
is the primary or secondary coverage. In
other words, non-Medicare stays are not
considered when counting benefit
periods to determine when a face-to-face
encounter must occur. The first
Medicare benefit period would begin on
the effective date of the first Medicare
hospice election.
To clarify the language used about the
timing of the requirement, we are
modifying our proposal and the
regulatory text to refer to the face-to-face
encounter as being required prior to the
3rd benefit period recertification and
each subsequent recertification.
Comment: Several commenters were
concerned that they could not provide
a face-to-face encounter within 15 days
prior to the 180th-day recertification or
each subsequent recertification. One
wrote that this timeframe is a barrier to
rational geographic batching of visits.
They cited difficulties due to shortages
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of physicians and NPs, particularly in
rural areas. Several commenters said
they would need to hire additional staff
but were concerned about being able to
successfully recruit a physician or NP
because of shortages, particularly in
rural areas.
One wrote that there are not enough
well-trained hospice practitioners in
this country to handle the potential
volume of these visits and asked if we
were concerned that the influx of
providers required to make these visits
would ‘‘water down’’ the quality of the
assessments, and negatively impact the
delivery of care to hospice patients.
Some noted that they have a part-time
Medical Director with a busy private
practice, who is simply not available to
make the visits. One noted that in urban
areas, traffic tie-ups add to the time
required to make these visits. Others
wrote that visits in rural areas require
significant travel time, sometimes as
long as 4 hours; one added that during
these visits, their Medical Director
would also be completely unavailable
by phone for other patient and staff
needs because in some remote areas
there is limited cell phone service.
One asked if there was a requirement
regarding the location(s) where a
required face-to-face visit could occur.
Another commenter wrote that the
language of the proposed regulation at
§ 418.22(c)(4) implies that the
practitioner must visit the patient at his
or her home, rather than allowing the
patient to come to the physician or NP.
This commenter suggested that we
change the regulatory text from ‘‘must
visit’’ to ‘‘have a face-to-face encounter’’
as specified by section 3132 of the
Affordable Care Act. A commenter
noted that in some areas, patients would
have to come to the physician, creating
a burden on patients and families.
Several commenters added that they
cannot get frail or dying patients to the
physicians because many cannot sit up
in a car, and in rural areas, Emergency
Medical Services (EMS) may be the only
option for transportation.
Another commenter wrote that
patients would not be able to afford the
ambulance ride to a physician’s office to
make the visit; others were concerned
that forcing a patient to travel to a
physician was an undue hardship on
both the patient and the family, would
expose the patient to potentially
infectious patients in the doctor’s office,
and could lead to exacerbation of
symptoms such as severe pain or
dyspnea.
One commenter suggested we
consider the impact of the required visit
on the family; another commenter wrote
that the required visits would be an
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added stress to the family as they wait
for confirmation from hospice staff that
hospice care can continue. Another
commenter wrote that if a patient
required ambulance transport to a
doctor’s office, it would be an
unreimbursed expense for the hospice,
and asked if Medicare could cover the
ambulance ride outside of the hospice
per diem payment amount. One
commenter said EMS will not cross
county lines, yet 21 percent of the
hospice’s patients lived in a different
county.
Another commenter asked if the
hospice could discharge a patient if the
patient or family refused the physician
visit, or delayed it, and noted that with
15 days, there may not be time for
adequate discharge planning. Several
noted that some states have minimum
discharge requirements, such as
Alabama with a minimum 30-day
requirement, which make the 15-day
timeframe unworkable; one commenter
asked how to handle the situation where
the recertification visit determines that
discharge is needed, but it occurs with
less than 30 days to plan, as required by
some State laws. This commenter asked
that we allow for adequate discharge
planning.
A few commenters asked what the
hospice should do if the visit cannot be
made due to scheduling difficulties,
inclement weather, unsafe road
conditions, or due to an emergency.
Another commenter said that a hospice
physician might not have an attending
physician’s dictation from the visit in
time to make the attestation, and ask for
more time to make the visits. One
commenter wrote that the time
constraints do not fit well with patients’
conditions if their disease trajectories
are in rapid decline. A commenter asked
what would be the impact on a hospice
if the required visit was not made in the
allowable timeframe but was earlier or
later. This commenter also asked if this
requirement only affected Medicare
hospice patients. Many commenters
asked for more time to make the visit,
suggesting 21 or 30 days.
Response: We appreciate commenters’
input on the problems in scheduling
these face-to-face encounters, and we
recognize that rural hospices, in
particular, may experience more
logistical difficulty due to the shortage
of physicians or NPs in some areas.
Based on concerns and
recommendations from the public
comments on potential logistical issues,
we are revising our proposed policy to
change the visit timeframe from up to 15
days prior to the start of the 180th-day
recertification, and each subsequent
recertification, to a visit timeframe of up
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to 30 calendar days prior to the 3rd
benefit period recertification, and each
subsequent recertification. We believe
this additional time will provide
hospices with the flexibility they need
to meet this Congressional mandate, to
provide adequate time for discharge
planning when indicated, and to
accommodate other logistical issues
discussed in the public comments.
We are unclear about the meaning of
the comment related to State laws about
discharge, and believe it may be outside
the scope of this rule. We are only able
to focus on the Medicare statute and
payment regulations, which require that
patients who are no longer eligible for
the benefit be discharged. The statute
does not allow us to pay for hospice
care for patients who are not eligible for
the benefit.
The regulations at § 418.26(d) require
hospices to have a discharge planning
process in place ‘‘that takes into account
the prospect that a patient’s condition
might stabilize or otherwise change
such that the patient cannot continue to
be certified as terminally ill.’’ The word
‘‘prospect’’ in this regulatory text
indicates that hospices should be
considering whether stable or improving
patients might become ineligible in the
future, and plan for a possible future
discharge.
Hospices are required to follow State
laws in additional to federal laws.
However, we do not see the
recertification requirement and any
State discharge requirements as being in
conflict.
If a patient or family member refuses
to allow the hospice physician or NP to
make the required visit, a hospice could
consider discharge for cause, as the
refusal would impede the hospice’s
ability to provide care to the patient.
The hospice would need to follow the
procedures for discharge for cause,
which are given in § 418.26.
In response to the comment
suggesting that we change the proposed
regulatory text at 418.22 (C)(4) from
‘‘must visit’’ to ‘‘have a face-to-face
encounter’’ as language of the proposed
regulation implies that the practitioner
must visit the patient at his or her home,
rather than allowing the patient to come
to the physician or NP, we are revising
the proposed language. We believe that
the Affordable Care Act allows hospices
the flexibility for patients to have a faceto-face encounter with a hospice
physician or nurse practitioner. We are
revising the regulatory text at
§ 418.22(a)(4) to now read, ‘‘As of
January 1, 2011, a hospice physician or
hospice nurse practitioner must have a
face-to-face encounter * * *’’ We expect
that hospices will not require patients to
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come to the hospice physician or NP for
the encounter if doing so would
exacerbate symptoms or otherwise
jeopardize the patient’s well-being; the
hospice Conditions of Participation
(CoPs) in § 418.100(a) require that
hospices provide care that optimizes
patient comfort, and is consistent with
the patient’s and family’s needs and
goals. All patient transport must occur
within the context of optimizing patient
comfort and meeting the specific needs
and goals of patients and their families.
If transportation to a hospice physician
would not optimize patient comfort
and/or meet the goals and needs of the
patient and family, the hospice
physician or NP would need to travel to
the patient. If a hospice patient
travelling to the hospice physician or
NP required ambulance transportation
because of his or her medical condition,
the ambulance transportation would be
included in the hospice per diem; it
could not be billed to patient.
We believe that the face-to-face
encounters will not be an added stress
to family members if they know they are
a routine part of the hospice
recertification process, and if the family
understands that the visit has the
potential to improve the quality of care
for their loved one.
In response to the commenter’s
concern that the patient’s attending
physician’s dictation might not be
available to the hospice in the 15 days
prior to the recertification, and this
would prevent the hospice from meeting
the 15-day timeframe that was originally
proposed, we believe that the
commenter appears to misinterpret the
statutory requirement. Pursuant to
section 3132(B) of the Affordable Care
Act, a hospice physician or hospice NP
must perform the encounter. The
definition of hospice physician is
addressed later in this section.
In response to the comments asking
for clarification about to which patients
the face-to-face encounter requirement
applies, we note that it only applies to
Medicare hospice patients.
Finally, we proposed clarifying some
language in our benefit policy manual
and aligning timeframes so that
recertifications could not be completed
more than 15 days prior to the start of
the subsequent benefit period. While the
entire recertification cannot be
completed more than 15 days prior to
the start of the benefit period, we are
clarifying that the face-to-face encounter
and its accompanying attestation are
only parts of the recertification, and
therefore can be completed up to 30
calendar days prior to the start of the
3rd benefit period recertification and
each subsequent recertification.
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Comment: Several commenters have
asked if the hospice face-to-face
encounter is billable, and if so what
reimbursement code should be used. A
number of commenters wrote that their
hospices do not have the resources to
accomplish this if the visit is not
billable; one wrote that this requirement
could have the potential to drive smaller
providers out of the market. They wrote
that this requirement would be a
financial burden, especially to rural
providers, in the face of reductions due
to the budget neutrality adjustment
factor (BNAF) phase-out and future
market basket cuts, declining charitable
donations, increased costs, and
demands for competitive wages. A few
commenters mentioned that hospices
will be absorbing more than a 14
percent reduction in their Medicare and
Medicaid reimbursement levels over the
next 10 years; they wrote that these
reductions are especially difficult for
the hospice community since hospice
programs are disproportionately
dependent upon Medicare and
Medicaid for reimbursement. These
commenters believe the upcoming
payment reductions place increasing
financial pressure on hospices that seek
to deliver quality care and comply with
additional administrative and regulatory
requirements.
A number of commenters wrote that
they could not afford this unfunded
mandate. One rural commenter noted
that their reimbursement is already
lower due to wage index adjustments,
and yet the costs of these required visits
will fall more heavily on rural
providers, with long distances to see
patients; this commenter believes the
burden to rural hospices was becoming
‘‘almost insurmountable.’’ Commenters
also mentioned the administrative costs
of coordinating the visits, of changing
existing forms and documents, and of
increased liability risks, and several
believe that these are not included in
the current hospice reimbursement.
Another noted that hospices would be
expected to pay physicians or NPs for
their travel time, visit time, and mileage,
and would have additional
administrative costs while receiving the
same per diem payment amount. One
commenter said that his hospice would
be forced to reduce services to patients
to pay for these visits. One commenter
wrote that this requirement creates a 2tiered system where providers are
compensated better for patients under
the 180-day recertification requirement
than for beneficiaries who require a
face-to-face encounter.
Several said that they would have to
hire someone full-time to make the
visits, which would create significant
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financial hardship without
reimbursement; one wrote that those
monies would be better spent on
providing quality care and on fair wages
for employees. A few added that having
a physician or NP spend hours traveling
to see patients would be a waste of
scarce human resources in areas where
there are physician or NP shortages. A
few mentioned that the net result would
be less patient care, and more time
spent on paperwork.
Nearly all commenters suggested
some form of reimbursement for the
visit, with one commenter writing that
all physician visits mandated by payers
should be billable separately by the
physician directly to the payer for
reimbursement. One commenter was
concerned that because these required
visits are medically unnecessary, there
would be no reimbursement for them,
yet hospices would still incur costs from
making the visits. Another commenter
added that many physicians or NPs
would order tests such at CAT scans or
lab tests to obtain results that justify
recertification of patients, and yet
would not receive reimbursement for
these tests.
A few commenters suggested that any
part of the visit that becomes medically
necessary, including those where the
doctor changes the plan of care (POC) or
makes medication adjustments, should
be billable. One commenter asked if a
hospice could bill the patient for the
face-to-face visit if it was not covered.
One commenter wrote that when the
Medicare hospice benefit was originally
designed, physician face-to-face visits
were viewed as an encounter for
additional counseling, education,
information, and support. The
commenter asked why any physician
face-to-face visit would not be billable.
Another commenter cited our
regulations at § 418.304, and asked if the
face-to-face visit was considered part of
the establishment and updating of the
plan of care, or is it outside the services
listed, and could be billed separately. If
the visits are part of the per diem
amount, the commenter encouraged
CMS to review the payment rates and
increase the per diem to reflect this
new, mandated service.
A number of commenters believe that
the face-to-face requirement was beyond
the administrative services provided by
the hospice Medical Director, and
outlined in the hospice claims
processing manual in section 40.1.1 (see
Internet Only Manual, 100–04, chapter
11). Several commenters wrote that
since active clinical work and a
comprehensive analysis will be required
of the physician (as distinguished from
simple documentation in the medical
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record), they believed that a billable
visit is appropriate. Another wrote that
while the medical decision-making is
primarily directed at determining
prognosis, in many cases, changes in
medication and patient management
may also be suggested. A different
commenter wrote that the face-to-face
encounter requires direct patient care
services, including a comprehensive
clinical assessment and is comparable to
the billing for evaluation and
management services provided in other
settings and should be reimbursed as
such. Another commenter wrote that
there is no precedent for a physician to
be required by law to provide a
thorough medical assessment of a
seriously ill patient and be constrained
from coding, billing, or seeking usual
and customary reimbursement for such
care.
For any portion of the visit that is
billable, commenters asked how to
document that billable portion,
including whether to make one note or
two. A number of commenters wrote
that their anticipated costs for the visits
would far exceed any reimbursement,
particularly given the travel time and
mileage costs. Another also noted that
there is currently no physician
reimbursement for Medicaid patients
visited by the hospice physician.
A few commenters noted that NP
services that are equivalent to physician
services are not currently billable unless
the NP is the patient’s attending
physician. One asked if this would
change under the proposed rule.
A commenter wrote that the Medicare
CoPs speak to the actions of a physician
providing medical care to a hospice
patient as separate from the role of the
Medical Director, and that these services
are accounted for differently in the per
diem payment rate. This commenter
wrote that the roles of these two
physicians are distinct, and that CMS
should consider providing adequate
reimbursement for the services being
required. Another commenter asserted
that if Medicare wants quality
healthcare, Medicare must allow
practitioners to bill for their time.
A few commenters wrote that there
was an established precedent in Skilled
Nursing facilities that encounters to
meet mandated requirements are
billable and reimbursed by CMS,
beyond the administrative duties of the
Medical Director. Given this
information, they asked us to clarify if
the mandated visit would be billable.
A commenter asked if we plan to
track face-to-face encounters with a
particular CPT code, and if it should be
reported on the claim. Another
commenter asked if we are concerned
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about the distortion of the actual cost
associated with providing care to
hospice patients if these visits are not
captured on the claim. Some
commenters asked us to devise a HCPCS
code to compensate the hospice
physician or NP for the time and
mileage for making these visits. Others
asked us to develop a billing code that
would include mileage costs and travel
time, and increase the per diems to
reflect the additional administrative
costs related to the proposal. One
recommended a separately reimbursable
fee schedule amount specific to face-toface encounter visits.
Response: We appreciate the
commenters concerns about the
financial effects of the face-to-face
requirement. However, the billing
regulations for hospice do not allow for
physician reimbursement for
administrative activities of physicians.
The certification or recertification of
terminal illness is not a clinical
document, but instead is a document
supporting eligibility for the benefit. In
the 1983 Hospice Care Final Rule,
certifications of terminal illness were
described as ‘‘simply determinations as
to the patient’s medical prognosis, not
the plan of care or the type of treatment
actually received’’ (48 FR 56010). As
such, the certification or recertification
of terminal illness has been excluded
from separate physician reimbursement
and has been considered an
administrative activity of the hospice
physician. The face-to-face requirement
is part of the recertification, and
therefore is an administrative activity
included in the hospice per diem
payment rate. In contrast, the SNF
bundle specifically excludes the
services of physicians and other
advanced practiced disciplines
including NPs. Therefore, SNF
physicians or NPs can bill for mandated
encounters, as these visits are not part
of the bundled payment.
The hospice face-to-face encounter is
an administrative requirement related to
certifying the terminal illness mandated
by the Affordable Care Act. By itself, it
would not be billable, as it is considered
administrative, as explained above and
in section 40.1.1 of the Claims
Processing Manual (Internet Only
Manual 100–04, chapter 11): ‘‘Payment
for physicians’ administrative and
general supervisory activities is
included in the hospice payment rates.
These activities include participating in
the establishment, review and updating
of plans of care, supervising care and
services and establishing governing
policies.’’ Determining continued
patient eligibility would fall under the
‘‘general supervisory services’’ described
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at § 418.304(a)(1), rather than under
review and update of plans of care
described at § 418.304(a)(2).
However, if a physician or nurse
practitioner provides reasonable and
necessary non-administrative patient
care such as symptom management to
the patient during the visit (for example,
the physician or NP decides that a
medication change is warranted), that
portion of the visit would be billable.
We believe that allowing for this type of
billing will not only increase the quality
of patient care, but also will help defray
the costs to hospices of meeting this
requirement. Hospices may not bill
patients for face-to-face encounters or
for any medically necessary physician
services provided during the encounter,
as these are hospice services. Billing for
medically necessary care provided
during the course of a face-to-face
encounter should flow through the
hospice, as the physician or NP who
sees the patient is employed by or
where permitted, working under
arrangement with the hospice (for
example, a contracted physician).
The commenter who wrote that
hospices cannot bill for physician
services provided by a NP unless the NP
is the attending physician is correct.
The regulations at § 418.304(e) only
allow nurse practitioner services to be
billed when the nurse practitioner is the
patient’s designated attending
physician. In order to be billable, this
regulation also requires that the NP
must provide medically reasonable and
necessary services that are physician
level services, and not nursing services
(that is, in the absence of a nurse
practitioner, the services would be
provided by a physician and not by a
nurse). The regulation also excludes
billing for services related to the
certification of terminal illness.
The hospice physician or NP that has
the face-to-face encounter with the
patient should ensure that any clinical
findings of the visit(s) are
communicated back to the
interdisciplinary group (IDG), for use in
coordinating the patient’s care. This is
particularly true if the physician or NP
discovers unmet medical needs during
the billable or non-billable portion of
the visit, so that the IDG can coordinate
with any attending physician. Hospices
are not to provide services that are
duplicative of what the attending
physician is doing and are responsible
for coordinating with the attending
physician if they provide any reasonable
and necessary patient care when having
a face-to-face encounter. If there is a
billable portion attributable to the visit,
hospices must maintain medical
documentation that is clear and precise
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to substantiate the reason for the
services that went beyond the face-toface encounter, and which apply to the
billed services; this can be done in one
note.
At this time, we do not plan to track
these required visits with a special CPT
code, or to create any additional HCPCS
codes related to these visits. In the
coming years, we will be reforming the
hospice payment system, and will be
analyzing hospice costs and
reimbursements to ensure that providers
are being paid fairly.
We are unclear about the meaning of
the comment that indicated that there is
currently no physician reimbursement
for Medicaid patients visited by the
hospice physician. However, we note
that the Medicare hospice benefit
reimburses hospice physicians and
attending physicians for reasonable and
necessary care provided to hospice
patients, whether the patients are dually
eligible or not. If the commenter is
referring to patients who have Medicaid
only, we suggest that the commenter see
his or her State Medicaid Manual,
particularly sections 4305.05 and 4307,
which deal with the Medicaid hospice
benefit and with physician services,
respectively. The paper-based State
Medicaid Manual can be accessed
through our Web site, at https://
www.cms.hhs.gov/Manuals/PBM/
itemdetail.asp?filterType=none&
filterByDID=99&sortByDID=1&sortOrder=ascending
&itemID=CMS021927.
Finally, the hospice face-to-face
encounter is only required for
recertifications when the patient is in
the 3rd benefit period or beyond. By
definition, hospice patients are
terminally ill, with a prognosis of 6
months or less if, the illness runs its
normal course. Therefore, the majority
of hospice patients should not require a
face-to-face encounter.
Comment: A number of commenters
wrote that hospices cannot currently
access accurate information in a timely
manner to determine the status of
previous hospice services. The
commenters expressed concern that a
hospice might admit a patient without
having complete or accurate information
about previous hospice services, and
therefore not be aware that a face-to-face
encounter could be required, resulting
in denial of payment. Commenters
stressed that without timely, accurate
information, it is impossible for
hospices to comply with this regulation.
Several asked if the fiscal
intermediary standard systems (FISS)
was available 24 hours per day, 7 days
per week, or if the fiscal intermediaries
(FIs) or Medicare Administrative
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Contractors (MACs) could impose down
times for maintenance, holidays,
weekends, or other reasons, noting that
many hospice admissions take place
after hours and on weekends, and
recommended that we review FISS
operating hours to ensure that it is
available at all times. A few wrote that
FISS cannot be accessed via secure
internet site from any computer, but that
hospices are required to purchase
individual licenses and connection
capabilities for each computer. One
wrote that if a patient is discharged
alive from a hospice more than six
months from the inquiry date in the
Eligibility Home Health Inquire (ELGH),
the ELGH screen fails to reflect the
previous hospice election, inaccurately
suggesting to the provider that the
patient had never elected hospice. One
noted that using the look-up systems to
determine a patient’s hospice history is
cumbersome. This commenter also
asked how far back benefit period
records are kept within FISS. Several
commenters noted that many hospices
do not bill in a timely fashion, which
places the receiving hospice at risk even
if the Common Work File (CWF) or
other resources are dutifully checked at
time of admission. One commenter
asked that we explore options to access
the FISS system, and to ensure
timeliness and availability of the
complete hospice history.
A few commenters asked who would
be responsible for monitoring the
patient’s time in hospice, to know if a
face-to-face encounter was required. The
commenters stated they would not
know the patient’s history otherwise.
One asked how a hospice would know
when the last face-to-face encounters
took place on patients who are
transferred or who came from out of the
area. This commenter also asked if a
hospice could rely on a previous faceto-face encounter if the patient is being
transferred from another hospice within
60 days of the last face-to-face
encounter. Several commenters asked if
the Provider Statistical and
Reimbursement Report (PS&R) would be
able to provide benefit period
information.
Some also wrote that hospices should
not be held accountable for failure to
provide a visit if the data systems were
unable to provide them with the
accurate and timely information needed,
or if the provider miscalculated the
certification or recertification dates and/
or face-to-face visit requirement because
of inaccurate system information.
Several asked that we provide clear
guidance as to what would constitute a
‘‘best effort’’ to secure a patient’s full
hospice history for establishing the
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proper benefit period, and ‘‘hold
harmless’’ those providers who have met
the ‘‘best effort’’ standard. One
commenter suggested we delay
implementation of the face-to-face
requirement until there is a CMS system
in place that is available 24 hours per
day, 7 days per week, and that providers
not be responsible for knowing about
prior hospice use if the data are not
available in FISS. This commenter
suggested that FISS operating hours be
reviewed and that CMS consider
requiring the FI/MAC contractors to
have FISS available for longer hours and
on nights, weekends, and holidays.
Response: Hospices are responsible
for verifying which benefit period a
patient is in at admission by using the
CWF to determine the beneficiary’s
benefit period. The CWF is used
because the FISS is responsible for the
actual processing and payment of
claims, and does not track benefit
periods. There are several CWF query
systems to determine which benefit
period a hospice patient is in. Both
ELGH and Health Insurance Query for
Home Health Agencies (HIQH) give real
time data; hospices should be using the
CWF queries for the most accurate
beneficiary information. If providers are
unsure how to use the CWF queries,
they should contact their MACs.
Because CWF has 9 host sites, a
provider would have to search through
up to 9 databases to determine if a
patient who moved from another part of
the country received prior hospice care;
a beneficiary’s records are only in 1 of
the 9 databases, so as soon as the
beneficiary is located, the search may
cease. Although this may be
cumbersome, the CWF is required to be
available from 6 a.m. to 6 p.m. Monday
through Friday and 6 a.m. to noon on
Saturdays, by the time zone of the host
site. We strive to have the CWF
available beyond these minimum
timeframes, but there are some regular
downtimes: every Saturday, usually
from 4 p.m. to past midnight, Sundays
from 7 p.m. to 9 p.m. (central time), and
the third Sunday of every month from
12 a.m. to 4 a.m. (central time).
The PS&R system cannot currently
provide the information needed to
determine the current benefit period,
and the revised system is still under
development.
If CWF is not available, hospices have
another option for verifying a patient’s
hospice benefit periods, using an
inquiry that is usually available 24
hours per day, 7 days per week, 365
days per year: the Health Insurance
Portability and Accountability Act
(HIPAA) Eligibility Transaction System
(HETS), specifically the 270/271
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transaction. Those hospices that file
their claims through a clearinghouse, or
which have a direct connection to CMS,
or whose MAC provides an Internet
portal, would have access to the HETS
system as a data source for their
eligibility. The HETS 270/271 inquiry is
in real time, but claim information lags
up to 24 hours. It is also a national
database, therefore there is no need to
search multiple host sites. A 270
transaction is a transaction query and a
271 transaction is the response to the
user. A 270 transaction query for a
patient’s benefit periods will return up
to 3 years of data, showing all prior
hospice benefit periods. This query
system can be used if the CWF system
is not available; providers can go to
https://www.cms.gov/HETSHelp/ for
information on the HETS 270/271
transaction, or they can call 1–866–534–
7315. Therefore, hospices have multiple
ways of verifying a patient’s prior
hospice history to determine which
benefit period the patient is in.
If a beneficiary has received hospice
care at another provider, commenters
are correct that the CWF may not be upto-date if that previous provider has not
billed promptly. We share commenters’
interest that the benefit period
information available via the CWF or
the 270/271 transaction should be as upto-date as possible. Hospices have a
financial incentive to bill in a timely
fashion, and in our claims processing
manual, we have encouraged providers
to file their Notice of Elections as soon
as possible after an election; similarly,
we have often encouraged providers
during the public CMS Open Door
Forum discussions to bill in a timely
fashion. In addition to checking our data
systems for benefit period information,
hospices can also ask the beneficiary (or
his or her representative) if he or she
has received hospice care previously. In
putting forth their ‘‘best effort’’ to
identify whether a patient requires a
face-to-face encounter, hospices should
not rely solely on data systems to
determine the benefit period, but should
also talk with the patient or
representative where possible, and
should document the information they
find along with the methods used to
find the information.
Several commenters suggested that we
‘‘hold harmless’’ those who rely on the
CWF response information to determine
whether a face-to-face encounter is
required. We are unable to provide
flexibility as the statutory language in
the Act requires a certification or
recertification in order for Medicare to
cover hospice days of care. If a hospice
has not had a required face-to-face
encounter, then the recertification
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would not be complete, and we would
be unable to cover the days of care that
were under that recertification.
However, we believe that the
flexibility afforded to hospices in
determining benefit period data
eliminates most situations where a
hospice does not have accurate benefit
period data. Furthermore, we believe
that in many cases, the patient or his or
her representative will know if hospice
care was provided previously. Based on
analysis of our FY 2007 claims data,
about 20 percent of all hospice
beneficiaries reach benefit period 3 or
later, and thus would require a face-toface evaluation. Of that 20 percent, only
a fraction of those beneficiaries might
have benefit period data that are not upto-date in the systems, and which
cannot be verified with the patient or
representative. In addition, of that
fraction, another fraction will show
benefit period 1 or 2, rather than period
3 or later, due to having prior hospice
care. Therefore, given the historical
data, we do not believe that this
situation will be common or that there
is a need to hold hospices harmless.
The Affordable Care Act requires that
a hospice physician or NP have a faceto-face encounter with any patient that
it admits in the 3rd or later benefit
period; prior face-to-face encounters
performed by previous providers cannot
be used to substitute for a face-to-face
encounter that is required by the current
hospice. In a transfer situation, the
benefit period does not change, so the
originating hospice would have been
responsible for any required face-to-face
encounter if the patient was in the 3rd
or later benefit period. When a patient
is in the 3rd or later benefit period
transfers to a new hospice, the receiving
hospice must recertify the patient, but it
does not have to have a face-to-face
encounter for that current period if it
can verify that the previous hospice
provided the visit.
In response to comments asking that
we delay the effective date, we note that
we are unable to delay implementation
of the face-to-face requirement since the
statutory language requires that it begins
on January 1, 2011.
Comment: Several commenters were
concerned about requirements when a
patient with a prior hospice stay
requires a visit upon admission to a new
hospice. This group of commenters
along with others also noted that during
a time of crisis, the need to admit the
patient for pain and symptom control
should take precedence over provision
of any required face-to-face encounter.
Another commenter was concerned that
requiring a face-to-face encounter would
create barriers to timely access and
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increase costs in situations where a
patient elects hospice, revokes, re-elects,
revokes, and re-elects in a short time
period. Recertification at this 3rd benefit
period would require a face-to-face
encounter. One commenter noted that if
a visit is required at admission, it may
unduly delay needed care or prove
impossible prior to death if the patient
is actively dying. Several commenters
wrote that if a patient requires a face-toface visit at admission, it will likely
result in a break in service until the
physician can make the visit; one
suggested this may lead to patient and
family complaints. This commenter
asked whether these complaints should
be referred to CMS, since the
commenter has no control over this
legislative mandate, and added that
denial of service is a serious issue,
especially if the patient is near death.
Several commenters asked that we
waive the face-to-face requirement for
patients who, because of prior hospice
enrollment, require a face-to-face
encounter at admission, but whose
death is imminent or who die within a
week.
One commenter asked what would be
required if a patient transferred near the
end of the 2nd 90-day period (for
example, at day 175), and the
recertification was not completed. The
commenter wondered how much time
the receiving hospice would have to
complete the face-to-face encounter.
Another commenter asked if providers
could rely on the previous hospice’s
face-to-face encounter if the patient was
being transferred from another hospice
within 60 days of the last face-to-face
encounter, and wondered how hospices
would know when the last face-to-face
encounter took place. A commenter
suggested that the initial and
comprehensive assessment be
communicated to the Medical Director,
to replace the need for a face-to-face
encounter, when a patient would
require one upon admission. When a
visit is required upon admission, several
commenters suggested timeframes after
admission to allow the visit, including
2 days, 5 days, 15 days, and 21 days.
Response: During a time of crisis, the
need to admit a patient and provide
pain and symptom control is a priority.
Since this is a new admission, whether
the patient is coming from another
provider type, from home, or is
transferring from another hospice, we
understand that the receiving hospice
may not have up to 30 calendar days
prior to the start of the benefit period to
have a face-to-face encounter. However,
the statute requires that the visit occur
‘‘prior to the 180th-day recertification
and each subsequent recertification
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* * *’’ (emphasis added). We do not
have the ability to waive a statutory
requirement or to allow the initial and
comprehensive assessments to replace
the required encounter.
As noted previously, in a transfer the
benefit period remains the same. When
a patient in the 3rd or later benefit
period transfers to a new hospice, the
receiving hospice must recertify the
patient; however, since the benefit
period does not change with a transfer,
the receiving hospice does not have to
have a face-to-face encounter for that
current period if it can verify that the
previous hospice provided the visit.
According to the hospice CoPs at
§ 418.104(e), the sending hospice must
forward to the receiving hospice the
patient’s clinical record, which includes
the certifications and recertifications of
terminal illness, if requested. The
clinical record can be used to verify
whether or not the sending hospice
provided any required face-to-face
encounters.
Our regulations describe
recertification as a process. We
currently allow 2 calendar days after a
period begins for a hospice to provide
either a written or a verbal certification
or recertification. If a verbal certification
is provided, the written certification,
including the narrative, must be
completed prior to filing the claim.
Therefore, certification or recertification
can occur at a point in time, but often
occur over a period of time.
In response to the comment asking
whether complaints should be referred
to CMS, we note that hospices are free
to refer complaints to us at CMS or to
Congressional representatives. We
welcome input, and would consider it
when evaluating our policies given the
constraints of the statute. We appreciate
the concerns that commenters have
raised about providing a visit upon
admission, particularly in rural areas.
We will be examining this issue to see
how it fits with the statutory and
regulatory language. In the meantime,
we will monitor the program for any
unintended consequences.
Comment: A number of commenters
requested flexibility in who could make
the face-to-face visits, and asked us to
clarify our interpretation of ‘‘hospice
physician or NP’’. One asked if there
was a distinction between the physician
as an employee (who received a W–2
from the hospice), a contract physician
(who receives a Form 1099 from the
hospice), or a volunteer. Others asked if
certification in hospice and palliative
care was required, or if full-time, parttime, or per diem status mattered. One
commenter wrote that the proposal to
require a ‘‘hospice physician or nurse
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practitioner’’ to perform the face-to-face
encounter was materially different from
the language in section 3132 of the
Affordable Care Act. This commenter
suggested that we take an approach
consistent with the definition of
‘‘physician designee’’ in § 418.3, and
allow the patient’s primary care
physician, specialist, hospitalist,
hospice Medical Director, or other
qualified physician to perform the visit,
provided that physician is willing to
certify eligibility for the benefit and
communicate the encounter results to
the hospice certifying physician.
Several commenters suggested
allowing a Physician’s Assistant (PA) to
perform the face-to-face encounter; a
few noted that in rural areas, PAs are
more common than NPs. Other
commenters asked if a hospitalist could
perform the visit. A third commenter
wrote that if a physician can collaborate
with a NP to make the visit, why not
also with a registered nurse (RN). One
commenter said that the requirement
that a physician make the visit was an
insult to both the RN case manager and
to the patient, and suggested that the RN
case manager is capable of making the
visit. The commenter added that the
proposed rule sends the message that an
RN case manager is good enough when
it merely involves a human being’s
needs, but when it comes to
reimbursement/money, a physician is
required. Another commenter wrote that
the Scope of Practice and Nurse Practice
Acts for all Registered Nurses
specifically allows for physical
assessment and expects
pathophysiology expertise. The
commenter also added that RNs are as
equally qualified as a NP to perform
these assessments and report findings to
the hospice Medical Director to
establish eligibility.
Another commenter raised concerns
about using a contracted physician to
make the visit; this physician may be
trained and may have reviewed the
chart, but it would likely be the first
time this doctor has seen the patient.
The commenter wrote that based on the
nurse’s notes, the patient has a steady
decline, but if the physician sees the
patient on a good day, the physician
may not believe that the patient is
eligible for hospice care, and may
recommend discharge. The commenter
believes and highly respects the
qualifications of physicians, in this case
the trained nurse, certified in hospice
and palliative care, has been seeing the
patient multiple times per week, and is
a better judge of the patient’s eligibility.
Several commenters asked if NPs
could sign the certification or
recertifications. A few commenters
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asked that we allow medical residents
or fellows to provide the face-to-face
visits if they are rotating through a
hospice or in a setting where hospice
patients reside. One commenter asked if
hospices can contract with physicians to
only provide the face-to-face
encounters, and what employment
requirements would those physicians
need to meet. Another commenter asked
if a hospice could have volunteer
physicians make the visit or contract
with another hospice, to have their
physician or NP make the visit.
A few commenters recommended that
a hospice be allowed to contract with a
NP for the purpose of making required
face-to-face visits, rather than requiring
a W–2 employment relationship only. A
commenter also asked that we clarify
that NPs providing the face-to-face visit
must meet Medicare’s general
qualifications for a NP and must be
licensed by the State in which they are
practicing, but that they do not have to
have a particular specialty certification
or credentials in order to be considered
a ‘‘hospice nurse practitioner’’ for
purposes of providing the face-to-face
visits. A few commenters asked if the
NP must be the patient’s designated
attending in order to make the required
visit. One asked if hospices could
contract with a NP even though the
hospice did not have a contract with the
physician supervising the NP. The
commenter added that in her area, there
were competing hospitals, which could
create a conflict of interest if the hospice
Medical Director was associated with
one hospital and the contracted NP with
a competing hospital. Another
commenter asked that we clarify how
supervision will work for contracted
NPs whose role is to make the face-toface visits.
Other commenters suggested that
advanced practice nurses such as
Clinical Nurse Specialists (CNS) could
make the visit and that allowing them
to do so would decrease the burden of
the visits in areas where there are
shortages of physicians or NPs, enabling
them to meet the requirement. One
noted that CNS can become certified in
hospice and palliative care.
A number of commenters suggested
allowing the patient’s attending
physician to perform the required visits.
These commenters noted that in many
rural areas, the hospice physicians do
not assume direct medical care of the
hospice patients, but instead determine
continued eligibility through review of
clinical findings reported by the
members of the IDG. The commenters
wrote that the attending physicians are
involved in these hospice patients’ care,
have a history with the patient, and may
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be geographically closer to the patient.
In advocating for allowing attending
physicians to make these required visits,
one commenter noted that because of
historical knowledge and perspective,
the attending physician’s medical
opinion should be deemed relevant and
critical to the delivery of hospice care,
and indeed his or her signature is
required on the initial certification. One
commenter stated that the proposed
regulation fails to recognize the ongoing
relationship between an attending
physician and the patient, by excluding
attending physicians from the
encounter. Another wrote that attending
physicians would make better use of
resources and be more in line with the
emphasis placed on attending physician
involvement in the 2008 Medicare CoPs
for hospices. A different commenter
wrote that allowing the attending
physician to make visits would be in
keeping with Medicare’s Home model.
A few asked if hospices could contract
with the patient’s attending physician to
make the visit, and if so, would the
billing be through the hospice or
through Part B. One suggested that such
billing should flow through the hospice.
A commenter suggested that for
hospice patients residing in a facility,
the facility physician should be allowed
to perform these face-to-face visits and
report them to the physician who will
sign the plan of care; the commenter
added that this would promote
coordination of care between the facility
and hospice.
A few commenters noted that in some
rural areas, the only available
physicians are employed by Rural
Health Clinics (RHCs) or FederallyQualified Health Centers (FQHCs).
Federal requirements applicable to both
of these provider types create barriers to
hospices wishing to work with them.
One commenter stated that Medicare
has recommended that RHC physicians
treat hospice patients after business
hours in a separate space other than the
RHC, billing under Part B, which further
inhibits health care provider
accessibility. Another commenter asked
for additional conversations with us to
discuss this issue.
A commenter stated that if a ‘‘hospice
physician’’ is interpreted to mean a
doctor who is employed by or under
contract with a hospice, or the patient’s
attending physician, hospices will begin
making contracts with doctors to pay a
fee for eligibility certifications whenever
the hospice staff physicians are unable
to have the encounter. The commenter
believed that the potential for abuse is
obvious, with payment given for
favorable eligibility determinations.
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Response: The statutory language in
the Affordable Care Act limits the
disciplines of those who can provide a
hospice face-to-face encounter to a
hospice physician or NP. A few
commenters asked why RNs could not
meet the requirement, particularly since
they are involved in the patient’s
ongoing care. This statutory provision
was based upon a recommendation
made by MedPAC. In its 2009 Report to
Congress, MedPAC reported that a panel
of hospice experts agreed that more
physician accountability was needed in
the certification and recertification
process. They wrote that the panel
discussed a tension that can exist
between the physician and
nonphysician hospice staff which can
lead to inappropriate recertification in
some cases. MedPAC’s panelists
believed that physicians sometimes
deferred too much authority for making
eligibility decisions to nonphysician
staff. They added that by virtue of their
day-to-day contact with patients, these
staff members may form emotional
attachments with patients that can color
their view and their charting of a
patient’s continued eligibility for
hospice (Medicare Payment Advisory
Commission, Report to Congress:
Medicare Payment Policy, Chapter 6,
March 2009, page 365, available at
https://www.medpac.gov/documents/
Mar09_EntireReport.pdf). The panelists’
comments were part of the impetus for
MedPAC’s recommendation regarding
the face-to-face encounter which the
Congress enacted in the Affordable Care
Act. Accordingly, by law, RNs (other
than NPs) are not allowed to perform
the face-to-face visit. This is in no way
intended to insult or to diminish the
importance of RNs in hospice care—
they are key to patient care in hospice,
and provide quality, compassionate care
to those at end-of-life.
A commenter was concerned about a
scenario where a contracted physician
who is unfamiliar with the patient
might see the patient on a day when the
patient is doing well, clinically, and
thus recommend for discharge when the
patient is in fact eligible. The
determination of eligibility involves
considering the terminal illness, related
conditions, co-morbidities, functional
status, clinical indicators, laboratory
results, etc. We believe the potential for
a truly eligible terminally ill patient
being found ineligible because he or she
was doing well clinically, on the day of
the encounter, is unlikely. Even so, the
decision to discharge the patient is not
made simply by the contracted
physician, but involves the members of
the IDG and the patient’s attending
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physician. Hospices should already
have policies and procedures in place
for handling a situation where there is
disagreement about continuing
eligibility.
PAs and CNSs are not authorized by
the Affordable Care Act to perform the
face-to-face visit. Moreover, section
1814(a)(7) of the Act explicitly prohibits
NPs from certifying or recertifying
hospice patients, and limits this
function to physicians only. Therefore,
we cannot adopt a policy to allow NPs
to certify or recertify patients without
change in the statute.
Hospices cannot routinely contract
with NPs, because NPs fall under
nursing, which is a core service. The
only situations under which a hospice
could contract with a NP would be
under extraordinary circumstances or if
the NP service is highly specialized.
Extraordinary circumstances generally
would be a short-term temporary event
that was unanticipated, and would not
include face-to-face encounters, which
are administrative in nature and which
are usually planned. Examples of
allowable extraordinary circumstances
might include, but are not limited to,
unanticipated periods of high patient
loads (such as an unexpectedly large
number of patients requiring continuous
care simultaneously), staffing shortages
due to illness, receiving patients
evacuated from a disaster such as a
hurricane or a wildfire, or temporary
travel of a patient outside the hospice’s
service area. Hospices may qualify for
an ‘‘extraordinary circumstance’’
exemption when they believe that the
nursing shortage has affected their
ability to directly hire sufficient
numbers of nurses. For details on this
waiver, please see the letter from CMS’
Survey and Certification group
found at https://www.cms.gov/
Surveycertificationgeninfo/downloads/
SCLetter10_31.pdf.
Hospices can employ NPs on a fulltime, part-time, or per diem basis if
needed to have face-to-face encounters.
As long as the NP is receiving a W–2
form from the hospice, or is
volunteering for the hospice, the NP is
considered to be employed by the
hospice.
Commenters asked about other
physicians who could be considered
‘‘hospice physicians’’ who could be used
to meet the face-to-face requirement,
including attending physicians. We
believe that to be a ‘‘hospice physician’’,
a physician must be either employed by
or working under arrangement with a
hospice (i.e., contracted). Section 418.3
defines a hospice employee as someone
who is receiving a W–2 form from the
hospice or who is a volunteer. We agree
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with commenters that the attending
physician has had a history with the
patient, has signed the initial
certification, and has typically remained
involved in the patient’s care while the
patient is under the hospice benefit. We
do not wish to diminish this physician’s
role; however, the regulations have
considered services of attending
physicians to be outside of the hospice
benefit (which is one reason why their
services are billed to Part B rather than
through the hospice to Part A), and
therefore we cannot include the
attending physician as a ‘‘hospice
physician.’’ By limiting ‘‘hospice
physician’’ to those physicians who are
employed by or working under contract
with a hospice, we also increase
accountability, as the hospice is in
control over its employees and
contracted physicians, but not over an
outside attending physician who might
have the encounter. Furthermore, as
part of the effort to increase
accountability, we are clarifying that the
hospice physician who has the face-toface encounter must be the same
physician who is composing the
narrative and signing the certification.
Given that the hospice is ultimately
responsible for the certification, part of
which is the face-to-face attestation, the
hospice needs control over the timing of
the staff visit, and over the preparation
and review of visit documentation,
which is used for the narrative and to
inform the decision whether to recertify
or not.
Other commenters suggested that nonhospice physicians other than attending
physicians should be able to make the
visit (for example, hospitalists,
specialists, primary care physicians,
etc). In addition to not meeting the
statutory criteria of being a ‘‘hospice
physician,’’ we agree with the
commenter who wrote that allowing
physicians who are not involved with
the patient’s overall care to have the
visit could lead to abuse, where an
unscrupulous doctor might continue to
support eligibility of ineligible patients
for a fee. Additionally, we do not
believe that allowing any physician to
have the required face-to-face encounter
would be appropriate because
determining eligibility for hospice care
requires knowledge of the patient’s
complete medical situation, including
the terminal illness, related conditions,
and other co-morbidities. Medical
residents or fellows who are rotating
through a hospice may provide the
required face-to-face encounter if they
are employed by the hospice or are
working under contract with the
hospice, and if they will be composing
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the narrative and signing the
recertification.
Physicians or NPs who volunteer for
a hospice are considered employees,
and could make the required visits. No
payment is made for physician or NP
services furnished voluntarily.
However, some physicians and NPs may
seek payment for certain services while
furnishing other services on a volunteer
basis. Payment may be made for services
not furnished voluntarily if the hospice
is obligated to pay the physician or NP
for the services.
We allow hospices to contract with
another hospice to serve their patients,
and would allow a hospice to arrange
with another hospice to use its
physicians to have the required face-toface encounter. Likewise, hospices can
contract with physicians for the purpose
of having face-to-face encounters with
their patients, but as previously noted,
the contracted physician must then be
the same physician who composes the
narrative and signs the certification.
Hospice physicians and NPs can be fulltime, part-time, or work on a per diem.
Hospice physicians and NPs are not
required to have certification in hospice
and palliative care.
NPs providing the face-to-face visit
must meet Medicare’s general
qualifications for a NP and must be
licensed as NPs by the State in which
they are practicing. Physicians must
meet the existing requirements for
physicians in section 1861(r) of the Act.
They must meet all State and local
requirements as required in § 418.116.
Finally, they must meet the licensed
professional requirements at § 418.62.
If physicians employed by RHCs or
FQHCs are also employed by or working
under arrangement with a hospice, they
could have the required face-to-face
encounter, however they must follow
statutory and regulatory requirements in
doing so.
In summary, we are defining ‘‘hospice
physician’’ as a physician employed by
the hospice or working under
arrangement with, or under contract
with, the hospice. A hospice NP would
be a NP employed by the hospice.
Comment: Several commenters asked
if the encounter could be done using
telephone or video technology, and still
meet regulatory requirements. A few
suggested that a nurse could be present
to do the physical examination under
the direct supervision of the physician,
who could still see the patient and
interact with him or her. Commenters
suggested such an approach would be
less burdensome and less costly,
accomplish the same objectives, and
open the door for critical but cost
effective physician care to underserved
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or rural areas. Commenters were
concerned about lack of human
resources to accomplish the visit,
particularly in rural areas, where
driving distances can be great,
increasing the cost of visits, and where
there can be shortages of physicians or
NPs. A commenter wrote that allowing
telehealth would be consistent with the
objectives of health care reform, and
would offset travel time and travel costs.
A few commenters noted that if
telehealth were available, it would not
help them due to lack of proper
communication infrastructure in some
remote areas; others noted that they
would be willing to invest in telehealth
to counterbalance the cost of sending a
physician on home visits.
Response: We appreciate the
commenters’ concerns about meeting
the face-to-face requirements in rural
areas, and their suggestions to consider
telehealth. However, section 1834(m) of
the Act does not include hospices as an
originating site for telehealth. Therefore,
hospice patients would have to go to an
originating site for the face-to-face
encounter. In our analysis of claims
data, we found that only 2.9 percent
patients who would require a face-toface encounter are in rural areas. Given
this small volume of patients, we
believe that not having telehealth does
not hamper hospices’ ability to meet the
Affordable Care Act requirements;
however, we will continue to monitor
this for any unintended consequences.
Comment: A commenter wrote that in
her hospice, the Medical Director would
perform the face-to-face encounter and
write the physician narrative. This
commenter and others asked if the
narrative and the face-to-face attestation
could be combined; one asked if the
visit note could serve in place of the
narrative when the attending performs
both functions. Several commenters
suggested the face-to-face requirements
were partially duplicative of the
narrative. One notes that physicians are
used to judging a patient’s condition
based on records. Other commenters
asked for clarification of the differences
between the face-to-face attestation and
the physician narrative, and about the
format, wording, and location of the
attestation, and about how notes for the
face-to-face encounter should be entered
in the chart; a few asked for consistent
guidelines for the narrative and the faceto-face attestation. One commenter
asked if the same physician is
responsible for both the visit and the
narrative, could the recertification visit
documentation form be combined with
the recertification of terminal illness
brief narrative form with both
attestations so that the physician does
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not have to dictate two separate notes
and sign two separate forms.
A few commenters asked if the
certification narrative and the face-toface may be performed by more than
one individual, or if hospice physicians
could cover for each other. A
commenter asked why a NP would
provide an attestation of the face-to-face
in addition to the physician. One
commenter wrote that the face-to-face
attestation should be a separate and
distinct section of the narrative, and that
providers should use an addendum
form for the face-to-face attestation if the
NP or a different physician from the
certifying physician has the encounter.
Another commenter asked if the NP
could prepare the narrative and have the
physician sign off on it. A few asked if
electronic signatures were permitted for
the attestation, narrative, and/or
certification or if the face-to-face
attestation could be dictated. One asked
if a medically necessary visit is made
within the same timeframe (proposed at
15 days), could the visit documentation
serve as the narrative requirement, or
would a separate narrative note be
necessary. This commenter also asked
whether it was a problem if the date of
the visit did not coincide with the date
of the attestation.
A commenter asked that the
attestation also include the National
Provider Identifier (NPI) of the
physician or NP making the visit, to
increase accountability. Another
commenter asked us to clarify what goes
directly above the certification
signature—the narrative or the face-toface attestation. Other commenters
asked that the narrative attestation be
placed above the physician’s signature
attesting that he/she composed the
narrative based on his/her review of the
medical record, or if applicable, his or
her examination of the patient. Another
commenter asked for guidance regarding
the validity of the narrative if a clerical
mistake is made in recording benefit
period dates or certification dates. This
same commenter noted that if his
hospice uses contracted physicians or
NPs to make the required face-to-face
visits, these practitioners will be less
familiar with the patient’s history and
disease progression, and stated that the
narrative has the potential to be more
informative about the patient’s
eligibility than the visit.
Another commenter asked if separate
documentation would be required for
any billable services provided during
the visit, or could the narrative serve as
the documentation. This commenter
also asked what the documentation
requirements for this visit would be.
Several asked if there would need to be
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separate notes for the face-to-face
encounter versus any billable portion of
the visit.
A commenter wrote that attesting that
an encounter has occurred and that
documentation has been relayed does
not confirm that the information was
utilized in confirming eligibility. This
commenter believes that the
responsibility for verifying that all
eligibility requirements have been met
should remain with the certifying
physician and be included in a single
attestation.
A few commenters wrote that the
additional attestation required for the
face-to-face encounter creates an
additional paperwork burden, and
creates issues with forms, transcribing,
timely documentation, and software
updates. One commenter wrote that the
final implementation date should be
delayed to allow time for providers to
update electronic and paper forms. A
different commenter believed that it was
burdensome, redundant, and
unnecessary to require a physician or
NP to attest in writing to having had a
face-to-face encounter, and reiterated
that the responsibility for verifying that
the patient meets all eligibility criteria
should remain with the physician and
be included in a single attestation.
Response: The face-to-face
requirement was added to the
requirements for physician
recertifications. Those requirements are
described in detail in our regulations at
§ 418.22. In brief, currently hospices
provide a signed certification or
recertification which:
• States that the patient is terminally
ill, with a prognosis of 6 months or less
if the illness runs its normal course;
• Includes a written narrative either
immediately prior to the physician’s
signature, or as a signed addendum. The
narrative includes a statement under the
physician signature attesting that by
signing, the physician confirms that
he/she composed the narrative based on
his/her review of the patient’s medical
record or, if applicable, his or her
examination of the patient; and,
• Is accompanied by clinical
information or other documentation
supporting the diagnosis.
The Affordable Care Act added a
fourth component to the certification,
with the face-to-face encounter and its
attestation that the visit occurred. We
proposed 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
proposed that the attestation language
be located directly above the physician
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or NP attestation signature and date
line.
Like the physician narrative, the faceto-face requirement is designed to
increase physician accountability in the
certification process, and to ensure that
beneficiaries are eligible for the hospice
benefit. While the purposes of the
narrative and the face-to-face visit are
similar, we do not believe that the two
are duplicative of each other. There is
value in having a physician see a
patient, rather than just reviewing
medical records about that patient, in
determining continued eligibility.
The face-to-face attestation is a
statement from the certifying physician
or the NP which attests that he or she
had a face-to-face encounter with the
patient; if a NP had the encounter, the
attestation should also state that the
clinical findings of that encounter have
been provided to the certifying
physician for use in determining
continued eligibility for hospice care.
Unlike the narrative, the face-to-face
attestation does not detail the clinical
findings of the visit, but simply attests
that the visit occurred. The regulations
describing the narrative require that it
be composed by the certifying
physician, therefore a NP could not
prepare it. We agree with the
commenter who suggested that
including the NPI of the individual who
visited the patient increases
accountability and we will consider
including the NPI the face-to-face
attestion in the future. We do not want
to prescribe language that hospices
should use in preparing the face-to-face
attestation, provided the attestation
includes the elements we have
described.
The face-to-face attestation statement
includes the date of the visit, and the
signature of the physician or NP who
made the visit, along with the date
signed.
The date of the face-to-face encounter
does not have to match the date that the
attestation was signed; however, both
dates should be included.
Several commenters asked if the
narrative could be combined with the
face-to-face attestation. The face-to-face
encounter can be conducted by either a
hospice physician who completes the
certification, or a NP, and the face-toface attestation must be signed by the
person who conducted the visit. The
narrative must be composed by the
certifying physician, who by signing,
attests that he or she composed it based
on his or her review of the medical
records and on examination of the
patient (if any). We are clarifying that if
a physician is the clinician who has the
face-to-face encounter, then the same
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physician should compose the narrative
and sign the recertification.
The hospice has the option of putting
both the face-to-face attestation and the
narrative, with its accompanying
attestation and signature, on the same
page of the recertification. We would
require that the format be such that the
face-to-face attestation appears separate
and distinct from the narrative and its
attestation; hospices are free to decide
how to separate the sections (that is,
through spacing, through lines, etc.). We
agree that for consistency, the narrative
and its accompanying attestation should
be above the physician’s signature, and
the face-to-face attestation should be
above its accompanying signature, and
are changing the regulatory text to
reflect this. If the narrative and its
attestation and the face-to-face
attestation are included as part of the
certification (rather than as an
addendum), we suggest, but do not
require, the order of the content to
appear as follows: The face-to-face
attestation (if applicable), followed by
the physician narrative, followed by a
narrative attestation, followed by the
physician signature. We believe this
order is logical as it allows the narrative
attestation signature to be the same as
the certification or recertification
signature for those hospices which
include the face-to-face attestation and
narrative as part of the main
certification document.
Hospices also have the option of
placing the face-to-face attestation, the
physician’s or NP’s signature, the
narrative, and its attestation and
signature, on a single page as an
addendum to the main certification or
recertification. They may also have the
face-to-face attestation and narrative on
separate pages as addenda to the
certification and recertification
documents. Finally, hospices may also
include either the face-to-face
attestation or the narrative in the main
certification document, and have the
other as an addendum. We are seeking
to give hospices greater flexibility in
how they include this information as
part of their recertifications.
In summary, the narrative and face-toface attestation may be included in the
main certification document, but should
be separate sections. They may also be
on a single page as part of the main
certification or recertification document,
or as an addendum. The face-to-face
attestation is completed by the person
who visited the patient: either a hospice
physician or a NP. If a NP saw the
patient and completed the face-to-face
attestation, the physician should not
also complete the face-to-face
attestation, because the physician did
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not make the visit. However, a certifying
physician would still have to compose
the narrative, using clinical findings
from any face-to-face visit, and sign the
narrative attestation.
We agree that attesting that an
encounter has occurred and that
documentation has been relayed does
not confirm that the information was
utilized in confirming eligibility. That is
why we require hospice physicians to
use the information from the face-to-face
encounter in composing the narrative.
We cannot combine the narrative and
the face-to-face attestations into a single
attestation because the statute allows
NPs to perform face-to-face visits, but
NPs cannot compose or sign the
narrative.
The face-to-face encounter must be
documented in accordance with hospice
policy using currently accepted
standards of practice. The
documentation from the face-to-face
encounter is part of the clinical record,
and should be used in composing the
written narrative. It is not necessary for
the physician or NP to make separate
notes for any billable services provided,
as long as the visit documentation
clearly supports any billable services
that were provided. Visit notes are not
a substitute for a physician narrative,
which is a brief explanation of the
clinical findings that supports
continuing eligibility for the hospice
benefit; the narrative draws on
information from a variety of sources,
and not just from notes of any face-toface encounter which occurs.
While the mandated face-to-face
attestation does create additional
paperwork for hospices, we believe that
we have provided sufficient flexibility
for providers to meet the requirement.
We appreciate hospices’ concerns about
required software changes and the
timing required to make those changes.
As noted earlier and again later in this
final rule, our timeframe was driven by
the required implementation date set by
the Affordable Care Act, which was
enacted in late March 2010. The statute
requires implementation as of January 1,
2011; thus, it does not provide
flexibility with respect to the date of
implementation.
Electronic signatures are permitted on
hospice certifications and
recertifications; the narrative and the
face-to-face attestation are parts of the
certification or recertification, and
therefore may also be signed
electronically. If a physician forgets to
date the certification, our longstanding
policy described in our benefit policy
manual in section 20.1 (Internet only
manual 100–02, chapter 9) states, ‘‘If the
physician forgets to date the
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certification, a notarized statement or
some other acceptable documentation
can be obtained to verify when the
certification was obtained.’’ The
certification or recertification applies to
the benefit period dates noted on the
document, therefore, if those dates are
recorded incorrectly, the hospice could
potentially have days of service denied
for coverage during a medical review.
Comment: A few commenters asked
how the recertification visits relate to
the local coverage determinations
(LCDs). One commenter wrote that her
hospice already completes guidelines
from the LCDs for recertification, but
much of this information requires prior
knowledge of the patient condition to
determine deterioration. The commenter
noted that if the expectation is that the
physician will be verifying the patient’s
condition based on the LCDs, this
should be clear. The commenter was
concerned about the situation where a
physician or NP visits the patient,
documents clear and valid reasons for
recertification, but subsequent review
determines the patient is not eligible
based simply on lack of certain
measures of decline. A few commenters
asked us to provide clear guidance on
what the face-to-face encounter should
include (that is, elements that make up
an encounter) for purposes of satisfying
the requirement.
One commenter asked how a hospice
should handle a situation where the
physician determines the patient is no
longer hospice eligible and discharges
him, but the Quality Improvement
Organization (QIO) finds the patient is
hospice appropriate. The commenter
wrote that it could not admit the patient
in good conscience and asked for
guidance.
Another commenter stated that he
hoped that CMS is funding research to
improve LCDs, saying that there is no
formula for predicting ‘‘six months or
less,’’ especially for non-cancer
diagnoses.
Response: In general, the face-to-face
encounter for recertification requires
that the same clinical standards be met
as for the initial certification. The faceto-face encounter enables the clinician
to assess the signs and symptoms in
relation to the patient’s terminal illness
to determine whether the patient meets
the clinical standards for recertification.
When assessing the patient for hospice
recertification, the medical records in
addition to the face-to-face examination
are utilized to provide a rationale for
recertification. The clinical findings
should include evidence from the three
following categories:
(1) Decline in clinical status
guidelines (for example, decline in
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systolic blood pressure to below 90 or
progressive postural hypotension);
(2) Non disease-specific base
guidelines (that is, decline in functional
status) as demonstrated by Karnofsky
Performance Status or Palliative
Performance Score and dependence in
two or more activities of daily living;
and
(3) Co-morbidities. For more
information about the criteria, please
see local coverage determinations
(L13653, L25678, or L29881). These
LCDs are on the CMS Web site in the
Medicare Coverage Database at https://
www.cms.gov/mcd/overview.asp. They
are also on the local contractors’ Web
pages.
Predicting life expectancy is not an
exact science. We are not currently
funding research related to LCDs;
research that could inform LCDs is
completed through a number of venues,
including academic institutions, the
private sector, and some government
agencies. In determining life expectancy
for conditions with less predictable
trajectories, hospice physicians are also
free to use any disease-specific scores or
scales that can help them in predicting
life expectancy. Some providers already
do so, and have reported that it
improves the accuracy of their
prognoses.
If a patient improves or stabilizes
sufficiently over time while in hospice,
such that he/she no longer has a
prognosis of 6 months or less from the
most recent recertification evaluation or
definitive interim evaluation, that
patient should be considered for
discharge from the Medicare hospice
benefit. Such patients can be reenrolled
for a new benefit period when a decline
in their clinical status is such that their
life expectancy is again 6 months or
less. Conversely, patients in the
terminal stage of their illness, who
originally qualify for the Medicare
hospice benefit but stabilize or improve
while receiving hospice care, yet have a
reasonable expectation of continued
decline for a life expectancy of less than
6 months, remain eligible for hospice
care.
A patient’s condition may temporarily
improve with hospice care. When
improvement is evident in
documentation such as physician
orders, medications, hospital records,
doctor’s records, other health records,
test reports, etc, contractors consider the
length-of-stay and the length of
sustained improvement.
There should be clear evidence of the
status of the patient’s conditions and the
clinical factors that caused the patient to
be not eligible or to be recertified as
terminally ill. If the patient is
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recertified, the medical records should
reflect the length of time the symptoms
have been evident, evidence of
progressive deterioration or sudden
deterioration, and increase in frequency
and intensity of hospice services and
medications.
If a patient appeals a pending
discharge to the QIO, the QIO decision
is binding; a hospice could not
discharge a patient as ineligible if the
QIO deems that patient to be eligible.
The provider is required to continue to
provide services for the patient. In the
QIO response, the QIO should advise
the provider as to why it disagrees with
the hospice, which should help the
provider to re-evaluate the discharge
decision. If at another point in time the
hospice believes that the patient is no
longer hospice eligible, the provider
should give timely notice to the patient
of its decision to discharge. The patient
could again appeal to the QIO, and the
hospice and patient would await a new
determination from the QIO based on
the situation at that time.
Comment: A number of commenters
were concerned that the required faceto-face encounter would create access
problems for patients, would delay care
and thereby lead to unnecessary patient
suffering, or would reduce the quality of
patient care. One commenter wrote that
doctors may be less willing to refer
patients to hospice if required to have
these encounters, while others were
concerned that patients would be
discharged; several suggested that the
face-to-face requirement could lead to
overall Medicare costs increasing as
these patients use emergency rooms and
inpatient services at end-of-life rather
than hospice. Several commenters were
concerned that those who were actively
dying would have care delayed if they
required a visit upon admission due to
previous hospice stays, as the hospice
may have to wait to get a hospice
physician or NP to see the patient.
Some commenters wrote that access
to hospice services may be limited for
patients who live in outlying areas,
because of the travel time required to
make the visits. Another commenter
wrote that lack of transport to bring
rural patients to a physician would lead
to denying access to care for many
elderly or bedbound patients unable to
have a timely face-to-face visit. A few
commenters suggested they may have to
reduce their service areas to meet the
requirement, which would jeopardize
access to hospice services for
beneficiaries in outlying areas. Another
commenter believed that with staff
shortages, meeting the face-to-face
requirement would require the hospice
to pull practitioners from patients who
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need the care and expertise of a
physician or a NP to make required
visits. The commenter believed this
would reduce services and lower the
quality of care that patients receive. A
few commenters wrote that the
requirement could lead to patient
discharge, with one noting that the
subsequent hospice would then have to
incur the cost of the required visit. One
commenter wrote that discharging
patients could lead to ethical dilemmas
or charges of patient abandonment. A
few commenters suggested that the
result of this mandate would be
increased cost to the health care system
if long-stay patients are discharged from
hospice care. One commenter asked
what options would be available to a
hospice, or to the patients, if agencies in
medically underserved areas are unable
to locate physicians or NPs who are able
and willing to make the required faceto-face visits.
A few commenters said that volunteer
Medical Directors used by rural
providers cannot make these visits,
which would force the hospice to
discharge patients. Another commenter
said that with the maturation of the
baby boomer generation, demand for
hospice services would be rising, at the
same time that fewer qualified
physicians are pursuing careers in
gerontology or palliative care, and
believes that this would intensify the
current situation. Another commenter
wrote that it is in his agency’s best
interest to have physicians certified in
hospice and palliative care to make the
visits, but that recent requirements for
an internship mean these physicians
will be in shorter supply, and therefore,
more costly to hospices.
A few commenters were concerned
that hospice programs may not be able
to manage this burden, and their closure
would affect vitally important access to
hospice services. One wrote that the
data collected by the Community
Hospice Partnership, a national
coalition researching the economic
sustainability of not-for-profit hospices,
estimates that the cumulative reductions
in reimbursement would lead to closure
of 65 percent of Wisconsin’s rural
hospices by 2014. The commenter
added that this proposed face-to-face
requirement was not considered in the
analysis, meaning rural Wisconsin
providers would be more severely
affected.
Response: We appreciate the
commenters’ concern about the
timeliness and quality of patient care
and about patient access to hospice
services. We believe that this provision
was included in the Affordable Care Act
to ensure the continued eligibility of
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hospice patients, who are supposed to
have a life expectancy of 6 months or
less. MedPAC, the OIG, and CMS have
concerns about the appropriateness of
some long-stay patients, who may have
been admitted to hospice care too early
in the course of their illness. The
hospice face-to-face encounter is only
required for recertifications when the
patient is in the 3rd benefit period or
beyond, which is after 6 months of
hospice care for those who complete
each benefit period. As mentioned
previously, we found that only 2.9
percent of all Medicare hospice
beneficiaries were in the 3rd or later
benefit period and in rural areas, where
physician or NP shortages are greatest.
Therefore, only a small percentage of all
Medicare hospice patients will both
require these encounters and will be in
a rural area where physician is more of
a concern.
With that perspective, we believe that
physicians will not hesitate to refer
appropriate patients to hospice. We
clarify, for the commenter, that it is the
responsibility of the hospice to ensure
that the face-to-face encounter occurs.
We do not allow outside attending
physicians to have the face-to-face
encounter, and the hospice is
responsible for either providing the
encounter itself or for arranging for the
encounter. Therefore, we do not believe
that physicians will reduce referrals
inappropriately, leading to unnecessary
suffering and increased Medicare costs
for patients at end-of-life. As noted in a
previous comment, a patient may
require a visit at admission and be
actively dying. In this situation, a
hospice physician or NP might see the
patient anyway, given the circumstances
cited; hospices are supposed to provide
physician services to their patients
when needed during a time of crisis.
Our data suggest that only 1.1 percent
of hospice beneficiaries live in rural
areas and require a face-to-face
encounter at admission. Therefore, we
believe this is an infrequent situation,
which will not lead to delays in care or
in the admission of the patient.
While we appreciate the additional
training and experience of those
physicians who specialize in
gerontology or in palliative care, we do
not require a hospice physician or NP to
be certified in those specialties.
Volunteer physicians are considered
hospice employees, and are permitted to
have face-to-face encounters with
patients. As previously noted, we also
are allowing hospices to bill for any
medically reasonable and necessary
patient care provided by a hospice
physician, or by a hospice NP who is
also the patient’s attending physician, in
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the course of a face-to-face visit.
Therefore, hospices will receive some
financial relief for the costs of having
these required visits, and should not
experience the financial burden some
commenters described.
As noted previously, we have also
doubled the time allowed for making a
required visit to 30 calendar days prior
to the recertification date to better
enable hospices to meet this
requirement. Given the additional time
for having face-to-face encounters, we
do not believe that hospices will need
to discharge patients due to lack of time
to complete the face-to-face encounters,
which could result in increases in nonhospice healthcare costs or which may
raise ethical issues. Similarly, if a
hospice physician or attending NP
cannot travel to the patient for the
required visit due to distance, time, or
other reasons, and the hospice is
encountering a shortage of physicians or
NPs such that it cannot find any to hire
or any physicians to contract with, the
hospice can have the patient come to
the physician or NP for the face-to-face
encounter, provided the hospice meets
the requirements in the CoPs regarding
patient safety and comfort. Having the
patient come to the physician or NP,
when appropriate, can also be
considered if a hospice is concerned
that using its staff to make required faceto-face visits would reduce services or
lead to lower quality patient care. We
believe that requiring a face-to-face
encounter with a hospice physician or
nurse practitioner will lead to increased
quality of care for hospice patients,
rather than decreasing quality of care.
We are unable to comment on the data
collected by the Community Hospice
Partnership, or their findings, as we do
not have those data, the study methods,
or findings, however, the
reimbursement allowed to hospices for
providing reasonable and necessary
patient care in the course of a required
face-to-face encounter should provide
financial relief to providers.
Comment: Several comments
suggested alternative approaches to the
face-to-face encounter to ensure
continued hospice eligibility. One
commenter suggested that hospices can
better manage their patients by
performing an automatic chart review
for long-stay patients, and include better
prognostication information on their
recertifications. This commenter also
wrote that her hospice is researching
using validated prognostication tools
which are disease specific, and which
can be done by a RN just as effectively
as by a physician. A different
commenter wrote that his hospice uses
a detailed review process for patients
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not showing decline, and is therefore
already performing what the proposed
rule is trying to accomplish. This
commenter suggested that we initially
enforce the face-to-face requirements for
all hospices but allow those providers
that have a lower rate of long-stay
patients to ‘‘opt out’’ in the future. The
commenter believes this would force
hospices to focus on admission
practices and not place an undue
burden on responsible providers.
Another commenter wrote that his
hospice’s Discharge Management
process is redundant in relation to the
face-to-face requirement, and asked that
we eliminate it. Another suggested that
we require a separate comprehensive
assessment for long-stay patients.
One commenter wrote that it seemed
like her hospice was being punished
because a lack of Federal oversight has
allowed some hospice programs to go
astray. Several commenters understand
the need to combat fraud and abuse; one
also suggested that uncontrolled growth
in the number of providers,
vulnerabilities in the payment systems,
and a diminished commitment to
integrity by some newer providers was
at the core of the problem, and led to illconceived regulatory changes. These
commenters suggested that better
enforcement of existing regulations,
closer inspection of documentation
through ADRs/medical review, review
by recovery audit contractors,
comprehensive error rate testing audits,
Medicaid program integrity audits, zone
program integrity audits, OIG
investigations, more frequent surveys,
and/or other interagency efforts to
combat Medicare fraud would be a
better approach. One commenter
suggested that if we are concerned about
the growth of hospice, we should
implement a moratorium on new
hospice providers for 5 years, where no
new hospices could enter a market
unless an existing hospice in that same
area closes. A few commenters wrote
that they believe the cap reimbursement
mechanism is the best control of
utilization rather than ‘‘Monday
morning quarterbacking prognosis’’ or
seeking confirmation of prognosis by a
visit by a physician or other
practitioner.
A few suggested we delay or suspend
implementation (often suggesting a
delay until January or February 2012),
or eliminate the requirement altogether.
One commenter asked that if we decide
to delay implementation, we notify the
industry immediately, rather than
waiting for publication of the final rule,
so that hospices could effectively plan
their staffing and hiring. Another noted
that hospices have not been allowed
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adequate time in practice to determine
the increased level of physician
involvement to meet this requirement.
One wrote that we should eliminate the
face-to-face visit prior to readmission, if
the two physicians agree to the
certification of terminal illness. Another
commenter suggested we only require a
face-to-face encounter if the Medical
Director has not made a visit within the
recertification period for other medical
issues.
Several suggested that we only require
the face-to-face for hospices that have a
higher than average length of stay, or
that we apply the requirement to
patients with stays greater than 240
days. Other commenters suggested we
waive the requirement for hospices that
tend not to enroll very long-stay
patients, or for small and rural hospices
with less than a 25–50 person daily
census, or for all rural hospices.
Another commenter suggested we
exempt patients and providers in Health
Professional Shortage Areas from the
requirement. One commenter suggested
that we only apply this mandate to
continuous service greater than 180
days with no break in service. A few
suggested we require the visit at 180days but only at every other or every
third recertification thereafter, or every
180 days thereafter; another suggested
we not require the visit at the benefit
periods after 180 days until the total
effects of the mandate have been
evaluated. Some suggested a phased or
stepped approach to implementation,
such as applying it to hospices with a
high proportion of long-stay patients
first. Another suggested 100 percent
review of patient stays over 180 days in
providers with an unusually high
percentage of ‘‘long-stay’’ patients. This
commenter wrote that this would be a
welcome edit targeted at problem
providers.
The same commenter also suggested
that the face-to-face encounter be crafted
around the provider and not the patient,
with the encounter required prior to the
180th day of care within a provider,
rather than over the patient’s entire
hospice history, with subsequent visits
required again at each 180-day interval
within that provider. This commenter
suggested that if the patient transfers or
is later admitted to another hospice, the
180-day count would start over. To
avoid having unscrupulous providers
that own other provider numbers in the
same geographic area make patient
transfers designed to dodge the visit
requirement, the commenter suggested
we could have a 100 percent review of
long-stay providers, using an edit of
chain-related providers.
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Another commenter suggested that if
there was greater than a 3- or 6-month
hiatus between hospice admissions, the
mandate should not apply to the total
hospice stay, but instead would start
with the subsequent hospice admission.
Other commenters suggested that the
hospice Medical Director could meet the
requirement with a phone consultation
with the patient while a hospice nurse
was seeing the patient, at the time of the
recertification visit. Another commenter
believes that since the patient is
reviewed by the hospice team at least
every 14 days, a physician is already
certifying his/her belief that the patient
is indeed eligible. Others wrote that
hospice nurses are trained in
recognizing and documenting the
appropriateness of patients, and are
familiar with the patients’ history.
These commenters stated the
requirement was an unnecessary burden
on hospices since nurses are adequately
handling this now, and could
communicate with the physician
regarding the continued need for care
and recertification.
Some commenters were concerned
that the impact of the narrative
requirement from the August 6, 2009 FY
2010 hospice wage index final rule (74
FR 39384) was not yet known, and were
concerned about the effect of the faceto-face requirement on rural providers.
One suggested we conduct studies first
to determine the effectiveness of the
narrative before requiring the face-toface encounter. Others suggested that
we waive the requirement in areas of
documented physician shortages, and
others suggested that we waive the
requirement for patients that require a
face-to-face encounter at admission and
who die within a week or who are
imminently terminal.
Response: We agree with the
commenter who suggested that
providers can improve their patient
management by performing automatic
chart reviews or other review processes
for long-stay patients. We also
encourage hospices to consider using
validated prognostication tools, when
available, to inform the larger process of
estimating life expectancy.
We agree that preventing fraud and
abuse is important; Medicare and other
agencies continue in their efforts to
identify providers who are abusing the
hospice benefit. We also agree that the
hospice aggregate cap is an effective
means of controlling inappropriate
utilization. We believe that while both
fraud and abuse prevention and the
aggregate cap are helpful in preventing
inappropriately long stays, they are not
the only means to do so. The face-toface requirement should reduce
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inappropriately long stays as physician
accountability in the recertification
process increases. In the effort to
prevent fraud and abuse, the aggregate
cap and the face-to-face encounter are
complementary approaches to dealing
with abuses in the hospice benefit.
A few commenters suggested targeted
medical reviews, and the Affordable
Care Act also requires medical reviews
of certain long-stay cases.
State governments, not the Federal
Government, control whether to place a
moratorium on new providers, so that
comment is outside of our purview.
In its 2009 Report to Congress,
MedPAC reported that a panel of
hospice experts agreed that more
physician accountability was needed in
the certification and recertification
process (Medicare Payment Advisory
Commission, Report to Congress:
Medicare Payment Policy, Chapter 6,
March 2009, pg 365, available at https://
www.medpac.gov/documents/
Mar09_EntireReport.pdf). The panelists’
comments were part of the impetus for
MedPAC’s recommending the face-toface encounter that the Congress
enacted in the Affordable Care Act.
Requiring another comprehensive
assessment for long-stay patients would
shift the burden of gathering
information to ensure eligibility from
physicians back to RNs and other staff,
which would defeat the purpose of the
MedPAC recommendation and would
not follow the statutory language.
Allowing a physician to speak by phone
with the nurse while he or she is
present with the patient is not a face-toface encounter as required by the law.
Section 3132(b)(2) states that the faceto-face encounter is effective beginning
on January 1, 2011. The statute is clear
and we have no discretion to delay,
phase-in, or suspend implementation,
regardless of the type of hospice (e.g.,
rural, those with small censuses, those
in areas of physician shortages) or for
any other reason (other than a change in
law). Nor can we apply the mandate to
select situations, such as to patients
with more than 180 days of continuous
service, to patients who haven’t seen the
medical director for another reason
within the recertification period. We
also cannot allow some providers to
‘‘opt-out’’ of the requirement after a
period of time, nor can we limit the
requirement to those hospices with a
higher percentage of long-stay patients,
or to those patients where two
physicians agree to the recertification.
We cannot craft the timeframe for the
face-to-face encounter around the
provider, as the statutory language is
explicit in requiring it at certain benefit
periods. Benefit periods are counted
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based upon a patient’s total Medicare
hospice history, rather than a patient’s
hospice history with a given provider.
We cannot deviate from the statutory
language which specifies when the faceto-face encounter must occur (‘‘prior to
the 180th-day recertification and each
subsequent recertification’’). We will
continue to monitor the data for any
unintended consequences from the
physician narrative or from the hospice
face-to-face requirement.
Comment: A few commenters asked if
hospices would be expected to perform
a face-to-face encounter in December
2010 for patients who will require a
face-to-face encounter during January
2011. One asked that we ‘‘grandfather’’
in patients whose recertification would
require a face-to-face visit in January
2011. Others asked that the requirement
only be effective for patients admitted to
hospice on or after January 1, 2011
rather than including patients who were
admitted prior to January 1, 2011, and
whose stays crossed into 2011. One
commenter wrote that this would allow
hospices to marshal the necessary
personnel and training resources, to
create systems, and to minimize
disruption in patient care.
Response: In implementing the
hospice face-to-face requirement, we
must follow the relevant statutory
language in the Affordable Care Act,
which says, ‘‘a hospice physician or
nurse practitioner has a face-to-face
encounter with the individual to
determine continued eligibility of the
individual for hospice care prior to the
180th-day recertification and each
subsequent recertification * * *’’.
The language does not require
hospices to have a face-to-face
encounter with existing patients who
entered the 3rd or later benefit period in
2010, and were recertified in 2010. It
does require that patients who enter the
3rd or later benefit period in 2011 have
the face-to-face encounter; the statutory
language does not give us flexibility to
‘‘grandfather’’ in existing patients. We
also believe that by extending the
timeframe for the face-to-face encounter
from 15 to 30 calendar days, hospices
will have the flexibility to meet this
requirement for patients who will enter
the 3rd or later benefit periods in 2011.
Comment: A commenter stated that
she is not aware of any data indicating
that a physician who sees a patient in
a face-to-face encounter once in a
6-month period is better able to
prognosticate than a skilled hospice
nurse who has seen the patient serially
over a 6-month timeframe. The
commenter added that unless the
physician’s one time face-to-face
assessment results in a more accurate
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prognosis, this requirement is of very
questionable value in the efforts to
improve the process. Another
commenter wrote that the additional
burden from the visit does not support
a face-to-face encounter; one wrote that
those who provide care ethically and in
compliance with regulations would
have an additional paperwork burden,
but this will not effectively eliminate
the unethical providers. Another
commenter wrote that it would be
extremely cumbersome to develop
processes in-house with electronic
records and software to meet the faceto-face requirements. One commenter
wrote that the proposal goes beyond the
mandates of the Affordable Care Act in
proposing additional layers of payment
cuts on top of the disproportionate cuts
already scheduled for hospice.
Another commenter said that it is not
always feasible, practical, or efficient to
require face-to-face encounters as
proposed. A commenter believed that
the attestation and narrative
requirement already created a burden
greater than the benefit for physicians,
patients, and agencies, and that this
additional face-to-face requirement
would serve as a further barrier to care
in areas where patients are already
underserved, an economic hardship for
small nonprofit providers, and would
ultimately result in decreased quality of
care for patients and increased costs to
Medicare through unnecessary testing,
procedures, hospitalizations, and
readmissions. A commenter wrote that
this face-to-face encounter requirement
would lead to decreased utilization of
hospice services, decreases lengths of
stay if hospices discharge patients too
soon, which may diminish the purpose
of hospice and mute its services. Other
commenters wrote that requiring a faceto-face visit by a physician or NP adds
a layer of complexity not only to the
hospice, but also to the patient’s
routine, due to travel, location, and
additional paperwork without any
compensatory benefit. One commenter
wrote that this new requirement does
little to truly benefit the patient or to
protect the hospice benefit from abuse.
Another wrote that patients in small
rural communities would be
inconvenienced because of the
fraudulent behavior of large for-profit
hospices.
Response: We appreciate the
commenters’ thoughts on the value of
the face-to-face encounter. We are taking
a long-term view of the encounter, and
expect that it will increase physician
accountability, lead to discharge of
ineligible beneficiaries thereby reducing
some lengths of stay, and improve the
quality of patient care. While we value
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the hospice nurse’s experience with the
patient, and his or her assessment of the
patient’s prognosis, we believe that faceto-face encounters with hospice
physicians or NPs can only improve
upon that process.
We do not believe this requirement
will decrease hospice utilization by
eligible patients. We also do not claim
that by itself, this requirement will
eliminate all abuse of the hospice
benefit. As noted previously in this
section, this mandate complements
other efforts related to protecting the
hospice benefit from fraud and abuse.
This requirement does not cut
payments, nor do we believe it is overly
burdensome. We have provided
financial relief for the cost of the visits
by allowing billing of reasonable and
necessary patient care by the hospice
physician or hospice attending NP that
occurs during a required face-to-face
encounter. We have also provided
additional flexibility in the timing of
visits, to assist rural providers. We
believe these changes help ensure that
this requirement does not serve as a
barrier to care in underserved area, and
will monitor for any unintended
consequences.
While changes in certification
requirements may lead to additional
paperwork or to software changes, we
do not believe that these will be
burdensome or overwhelming; rather
they are a routine cost of doing
business. We have also provided
hospices with great flexibility in how
they include the face-to-face attestation
as part of their recertification
documents. We agree that the allowable
timeframe for making changes to
software or to electronic records is
short, and have addressed these
concerns later in this section.
We believe that in the long-term, it
will strengthen the hospice benefit by
returning it to the benefit the Congress
intended, for patients who are
terminally ill with 6 months or less to
live. We are concerned that the hospice
benefit is being used by some providers
to care for chronically ill patients rather
than terminally ill patients, or to serve
as a long-term care benefit. We believe
that this face-to-face requirement may
help to ensure the continued viability of
Medicare’s hospice benefit for those at
end-of-life.
Comment: A number of commenters
wrote to support the intent of the rule
to certify only those hospice patients
who remain eligible for the hospice
benefit or to increase physician
accountability, though a few mentioned
that those who abuse the benefit would
find a way to circumvent the
requirement or that the proposed rule
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was too stringent. One wrote that it is
a wise way to counter the growing use
of hospice services by those who are
chronically ill, rather than terminally
ill. Another commenter values the sort
of practice, which was proposed as it
ties the persons of the treatment team
with the patient and with the family. A
few commenters also supported our
proposal that a certification or
recertification could be completed 15
days prior to the start of the benefit
period. A commenter from a non-profit
hospice wrote that the Congress’ and
CMS’ faith in the value of physician
certification to halt abuse was
reasonable, and was important for the
nonprofit hospice community to
support.
Response: We thank the commenters
for their support.
Comment: A commenter was
concerned that the timing of the
proposed rule, with the open comment
period until September 14th and a final
rule not due out until late October or
mid-November, puts a considerable
burden on providers and their patient
management software companies. The
commenter wrote that software changes
would need to be made based on the
proposed rule, and that her software
company could not beta test its changes
because there is not enough time to do
so, and to get the software out in
November. The commenter added that
any changes CMS makes between the
proposed and final rules are difficult to
accommodate, but obviously necessary.
The commenter believes that in the
future it would be more reasonable for
CMS to publish proposed rules with
adequate time for comments, review,
and a final rule to be published several
months before the effective date, so that
software companies and their clients
would have adequate time to prepare for
the changes. The commenter added that
due to the number of unresolved issues
with the face-to-face proposal, the
regulation effective date may be delayed
which would also impact the timing of
hiring of additional staff. A few
commenters wrote that the timeframe,
from publication of the final rule to its
effective date, means that hospices have
little time to meet with current
physician staff to determine if they can
manage the required visits, and to hire
and train additional physicians and NPs
if needed; several asked for more time
to hire and train additional staff.
Response: The hospice face-to-face
requirement was included in the
Affordable Care Act, which was enacted
on March 23, 2010. Conforming
amendments were added to that law on
March 30, 2010. We typically publish
hospice payment-related proposed rules
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in April and final rules in late July or
early August. Because of the internal
process to publish a proposed rule by
the end of March and the date the
Affordable Care Act was signed into
law, it was too late to include the
provisions related to the face-to-face
requirement in a hospice proposed rule.
The most appropriate rulemaking
publication we could use was the HH
proposed and final rules. In addition,
the HH payment rules have an effective
date of January 1st while the hospice
payment rules are effective on
October 1st.
When we propose and finalize
changes to policies, we try to do so with
a timeframe that provides adequate time
and flexibility to providers, contractors,
and software vendors, to implement
final rule requirements. In this case, the
timing of the enactment of the
Affordable Care Act led us to propose
the requirements later than usual; the
effective date of the face-to-face
requirement is mandated in the statute,
and we cannot change it. However, the
timing of the proposed rule allowed for
a 60 day public comment period and the
final rule will be effective on January 1,
2011.
Comment: Some commenters asked if
they were expected to report the
required face-to-face visit on their
claims. One wrote that if hospices are
expected to report the visit, they should
be paid for it. A commenter asked
whether hospices should report the NP’s
NPI number on the claim or the NPI
number of the physician supervising the
NP. Several commenters asked if any
special codes should be included on
claims when the face-to-face visit is
combined with a patient care visit, or
when the face-to-face visit occurs during
a medically necessary physician visit.
Response: We are not requiring any
visit reporting for the required face-toface encounter on hospice claims. This
is consistent with our policy of not
currently requiring reporting of other
administrative activities on hospice
claims. Hospice claims currently show
the NPI of the attending physician (who
may be a NP) and the certifying
physician, at the claim level rather than
showing the NPI of a practitioner at the
line-item level. If hospice physicians or
attending NPs provide billable services
(as described previously in this section)
during the course of the visit, those are
to be billed on the claim following usual
physician billing procedures, using
revenue code 0657 and the appropriate
CPT codes. If billable NP attending
physician services are included on the
claim, the claim should also include a
GV modifier, since NP services are paid
at 85 percent of services provided by
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physicians. The NP’s NPI number
would only be reported on the claim if
the hospice NP is also the patient’s
attending physician.
Comment: A commenter wrote that
hospice programs have raised concerns
that hospice physicians or NPs may,
during their visit to gather clinical
findings to meet the face-to-face
encounter requirement, be expected, by
the patient or family members, to treat
the patient for issues that are not related
to the terminal diagnosis. The
commenter noted that this is a
particular concern in cases where the
patient is not under the direct medical
care of the hospice Medical Director but
under the care of his or her primary care
physician. The commenter suggested
that CMS should acknowledge the
potential for such professional/ethical
conflicts and make every effort to avoid
establishment of any barriers (either
through hospice CoPs or coverage
requirements) that would prevent the
physician or NP from providing
adequate notice or explanation to a
patient or responsible family member
regarding the purpose of the hospice
face-to-face encounter.
Response: The hospice physician is
responsible for providing care for the
terminal illness and related conditions,
and for caring for any unmet medical
needs that the patient’s attending
physician (if any) has not addressed. If
both the hospice physician and the
attending physician are involved in the
patient’s care, the patient is taught who
to consider ‘‘primary’’ and contact first.
The hospice is to collaborate with the
patient’s attending physician (if any) in
obtaining the initial certification, in
performing the comprehensive
assessment and any updates to that
assessment, in developing the written
plan of care, in discharging the patient,
etc. Therefore, there should already be
a working relationship with the
patient’s attending physician; in having
a required face-to-face encounter, the
physician or NP should coordinate with
the attending physician in providing
any care to the patient. Because the
required face-to-face encounter is
usually an expected event, the hospice
has time for such coordination. If the
hospice physician or attending NP
provides reasonable and necessary
patient care while making a required
face-to-face visit, the hospice may bill
for those non-administrative physician
services, as described previously in this
final rule.
Comment: A commenter wrote that
CMS has provided no clarity regarding
the hospice’s exposure should the faceto-face requirement not be met.
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Response: The face-to-face
requirement is part of the hospice
recertification process. Having a valid
recertification is a statutory requirement
for coverage and payment. We would
have grounds to demand and recoup
payments for claims that were paid
based on an invalid recertification due
to not satisfying the face-to-face
requirement.
Comment: A commenter
recommended that CMS continue to
accept the hospice date stamp on POCs
returned to the agency by physicians
who forget or fail to date their signature
on this document.
Response: At this time, there is
nothing to preclude a hospice from
using a date stamp if a physician fails
to date his or her signature on the POC.
Comment: One commenter wrote that
including the benefit period dates on
the certification and recertification
forms imposes a clerical task in
physician charting. The commenter
asked why this was proposed if the faceto-face encounter requirement is based
upon actual days of care.
Response: As noted previously, the
face-to-face encounter is based upon
benefit periods and not on actual days
of care. Therefore, it is helpful to show
benefit periods on the certification. As
we wrote in the proposed rule, having
the benefit 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. Additionally,
including the benefit period dates on
certifications or recertifications
simplifies the medical review process.
The physician does not have to be the
one to fill in the benefit period dates,
but he or she should know what period
of time the document covers.
Comment: A commenter wrote that
this rule was proposed as intended to be
applied to hospices that routinely skew
the length of stay averages with long
lengths of stay and exceed the hospice
caps. The commenter added that it is
now applicable to every certified
hospice regardless of appropriate
lengths of stay or not.
Response: Our proposal is entirely
based on section 3132(b) of the
Affordable Care Act. The Affordable
Care Act did not limit the face-to-face
requirement to certain hospices, but
required it of all certified hospices.
Comment: A commenter wrote that if
CMS plans to reimburse the face-to-face
visits, long term care (LTC) facilities
should not be involved in hospice
billing as the proposed rule is clearly
focused on hospice operations, not
those of the LTC that contracts with the
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hospice so patients may receive hospice
services. The commenter asked that if
CMS anticipates any increased
responsibilities of LTC providers, that
his organization be included in any
stakeholder discussions. Finally, the
commenter asked that we clarify that
the role of LTC providers will not
change under this new regulation.
Response: These requirements affect
hospices only and do not affect or
change the responsibilities of LTC
providers that serve hospice patients
who reside in their facilities.
Comment: A commenter asked if the
new requirement for physician or NP
face-to-face encounters replaces current
RN assessments of hospice patients.
Response: This new requirement does
not affect the roles and responsibilities
of hospice nurses. Hospice nurses
should continue to care for and assess
patients in accordance with the CoPs.
They should continue to provide care
for the palliation and management of
the terminal illness and related
conditions.
Comment: A commenter asked if the
new face-to-face requirement allowed
the Medical Director to certify hospice
patients. Several commenters urged that
electronic signatures be accepted for
certifications and recertifications or on
the attestations. Another commenter
asked if having a different diagnosis at
admission would affect the face-to-face
requirement.
Response: Hospice Medical Directors
have always been able to certify or
recertify hospice patients. Additionally,
electronic signatures on certifications
and recertifications continue to be
allowed; the narrative and the face-toface attestation are parts of the
certification, and therefore both can be
signed electronically. The new face-toface requirement does not affect either
of these policies. The face-to-face
encounter is required based upon being
in the 3rd or later benefit period,
considering the entire hospice history,
regardless of diagnosis.
Comment: A commenter wrote that if
the face-to-face encounter must occur
within 2 weeks of the start-of-care date,
and be documented, the industry could
not afford this. This commenter noted
also that hospices have little or no
influence over physician behavior to
comply with the additional scheduling
and documentation requirements of this
proposed rule.
Response: We believe this comment is
related to the HH face-to-face
requirement, but it was unclear from the
language used, so we will respond from
a hospice perspective. The hospice faceto-face certification is not required at
start-of-care unless, when considering
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the patient’s entire hospice history, the
start-of-care coincides with the
recertification at the 3rd or later benefit
period. If a hospice employs or contracts
with a physician, it has influence
regarding physician compliance with
these requirements.
Comment: A commenter wrote that a
recent Duke University study showed
that patients who died under the care of
hospice cost the Medicare program an
average of $2,300 less than those who
did not. This commenter believes that
the current reimbursement model no
longer fits with the evolution of the
hospice benefit since 1983. The
commenter also believes that this
maturation of hospice necessitates a full
scale review and evaluation of the
current reimbursement model. The
commenter added that changes to the
benefit and payment system should
preserve access the hospice benefit,
quality care, and reasonable
reimbursement rates to maintain a
viable and stable delivery system. The
commenter also wrote that hospice
patients should not have to forgo
curative care that might lengthen their
lives and enhance their quality of life.
This commenter also wrote that the
Congress should prevent CMS from
implementing payment rate cuts in
hospice until the Secretary is able to
justify that the cuts do not negatively
impact patients and access to care. The
commenter suggested that the Congress
prevent us from implementing the
payment rate to ensure the full market
basket update for the hospice benefit,
and that they preserve the BNAF;
commenters suggested a rural add-on
payment to ensure access for rural
patients and to compensate for the
financial burden of the face-to-face
visits.
A few commenters who opposed the
elimination of the BNAF wrote that we
moved the hospice wage index away
from one which was agreed upon years
ago; one asked that we suspend the
phase-out until a better approach for
wage index adjustment is developed.
Another commenter believes the
hospice wage patterns do not mirror
those of hospitals. This commenter
wrote that hospices compete in the same
labor market as hospitals, which are
allowed to reclassify. The commenter
urged us to develop a voluntary pilot
project to test a hospice specific wage
index, and hopes that we will slow the
phase-out. A few commenters also urged
that we maintain the aggregate hospice
cap, as it protects against abuse of the
benefit. One supported our efforts to
improve the calculation and
enforcement of the cap, provided those
efforts do not take away from payment
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reform. A different commenter
suggested we have standards for data
submitted on cost reports and not use
data from agencies that submit reports
that are missing required information.
Response: Some of these comments
are outside the scope of this rule so we
will not respond to them in this final
rule. However, we will respond to those
comments related to the Affordable Care
Act. Section 3132(a) of the Affordable
Care Act requires that we begin
reforming the hospice payment system
no earlier than October 1, 2013. We
have been collecting additional data
from hospices for several years now, in
preparation for payment reform. Any
reformed payment model that we
propose would preserve access to
hospice care, encourage quality care,
and would fairly pay providers. Section
3140 of the Affordable Care Act requires
that we conduct a concurrent care
demonstration project where hospice
services will be provided without the
beneficiary having to forgo curative
care. The results of this 3-year
demonstration project will help inform
future decisions about any changes to
the hospice benefit. In the Affordable
Care Act, the Congress also reduced the
market basket update for hospice, but
those reductions will not occur until
2013, and therefore are not included in
the FY 2011 payment rates. We do not
have the statutory authority to provide
a rural add-on to hospices. The BNAF
phase-out was finalized in the August 6,
2009 final rule, and is outside the scope
of this rule. Likewise, the hospice wage
index, cost reports, and cap are outside
the scope of this rule, and therefore we
cannot comment, though we appreciate
the commenter’s support regarding the
hospice aggregate cap.
In summary, as a result of the
comments we received on the proposed
rule, we are finalizing the proposals
made in the proposed rule with the
following changes:
• We are changing the regulatory text
at § 418.22(a)(4) to clarify that we are
counting a beneficiary’s time across all
hospices based upon benefit periods
rather than on actual days of hospice
care. Therefore, a face-to-face encounter
will be required prior to the 3rd benefit
period recertification and each
recertification thereafter.
• We are clarifying in the regulatory
text at § 418.22(a)(4) that the hospice
physician or nurse practitioner is not
required to go to the patient for the faceto-face encounter, but that the patient is
allowed to travel to the hospice
physician or nurse practitioner when
medically appropriate.
• We are changing the regulatory text
at § 418.22(a)(4) so that hospice
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physicians or nurse practitioners will
have up to 30 calendar days prior to the
3rd benefit period recertification, and
up to 30 calendar days prior to each
recertification thereafter, to have the
face-to-face encounter.
• We are changing the regulatory text
at § 418.22(b)(3)(iii) so that the narrative
attestation is directly above physician’s
signature, rather than directly below it.
• We clarified that hospices may bill
for reasonable and necessary care
provided to the patient by a hospice
physician in the course of having a
required face-to-face encounter with a
patient.
III. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 30day notice in the Federal Register and
solicit public comment before a
collection of information (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 rule,
we are clarifying our coverage
requirements for skilled services
provided by therapists, which are
described in § 409.44(c). Our
clarifications include requirements to:
Document necessity for a course of
therapy (§ 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
(§ 409.44(c)(2)(i)); document any
variable factors that influence the
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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 clarifications to our coverage
requirements in § 409.44(c) are already
part of our current Conditions of
Participation (CoPs) and are approved
under OMB# 0938–1083. The current
CoPs at § 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, § 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 clarifications
to our coverage requirements in
§ 409.44(c) reflect longstanding policy
from our CoPs as well as from accepted
standards of clinical practice, we
believe that these requirements will not
create any additional burden on HHAs.
Additionally, our coverage regulations
at § 409.44(c)(2)(i) already mandate that
for therapy services to be covered in the
HH setting, the services must be
considered under accepted practice to
be a specific, safe, and effective
treatment for the beneficiary’s
condition. We are revising
§ 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 § 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
requirement to perform a functional
assessment at the 13th and 19th visits,
and at least every 30 days, will also not
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create any burden on HHAs. Rather, we
have clarified the minimum timeframes
for functional assessments in the
coverage regulations. Longstanding CoP
policy at § 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
HHA 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 are revising
§ 489.28(a) to state that a newly
enrolling HHA must consistently
maintain sufficient capitalization
between the time it submits its
enrollment application until 3 months
after its provider agreement becomes
effective. The HHA will therefore be
required to submit proof of
70455
capitalization at multiple points during
this period.
In the proposed rule, we estimated
that a newly enrolling HHA would be
required to submit such proof 3 times
prior to receiving Medicare billing
privileges, and that the burden involved
in doing so would be 1.5 hours on each
occasion. We further projected that 500
newly enrolling HHAs (of which 200
would become enrolled) would be
requested to furnish this data. The total
annual burden would therefore be 2,250
hours (500 HHAs × 3 submissions × 1.5
hours).
We are adopting the aforementioned
estimates for this final rule. These
estimates are reflected in Table 14.
TABLE 14—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
OMB No.
Requirement
Respondents
Responses
Hour burden
Total
None ......................................................
§ 489.28(a)
500
500
4.5
2,250
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C. ICRs Regarding the Home Health
Face-To-Face Encounter Requirement
The Affordable Care Act amends the
requirements for physician certification
of HH services contained in sections
1814(a)(2)(C) and 1835(a)(2)(A) of the
Act by requiring that prior to certifying
a patient as eligible for HH services, the
physician must document that the
physician/NPP 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 HH benefit (see sections
1814(a)(2)(C) and 1835(a)(2)(A) of the
Act). In this rule, we are amending
§ 424.22(a)(1)(v) to require the certifying
physician sign and date the
documentation entry into the
certification that the face-to-face patient
encounter occurred no more than 90
days prior to the HH start of care date
by himself or herself, or by an allowed
NPP for initial certifications. We are
requiring 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
nonphysician practitioners includes the
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time for each HHA 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 HHAs that filed
claims in CY 2008. We estimate it
would take each HHA 15 minutes of the
HH 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 HH episodes
in a year based on our 2008 claims data.
As such, the estimated burden for
documenting, signing, and dating the
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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 HH
services and meets the eligibility
requirements to receive the benefit.
Therefore, our making this requirement
explicit in the regulation poses no
additional burden to HHAs.
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 strengthening our regulations at
§ 424.22 to achieve consistency with the
timing and documentation of the faceto-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 HHA 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. Tables 15 and 16
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summarize the burden estimate
associated with these requirements.
TABLE 15—ESTIMATED ONE-TIME FORM DEVELOPMENT BURDEN
OMB No.
Requirement
HHAs
Responses
Hour burden
Total
(hours)
0938–1083
§ 424.22(a)(1)(v)
9,432
1
.5
4,716
TABLE 16—ESTIMATED PHYSICIANS BURDEN FOR DOCUMENTING, SIGNING, AND DATING ENCOUNTER
OMB No.
Requirement
Patients
Responses
Hour burden
Total
(hours)
0938–1083
§ 424.22(a)(1)(v)
2,926,420
1
.0833333
243,868
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Details of our burden estimates are
availabe 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 final
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 3rd benefit period
recertification and at every subsequent
recertification. We will 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 is 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
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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 90 percent of the visits
were performed by physicians and 10
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, regulation text changes to require
this narrative to 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
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.
In addition, commenters asked that
we change the regulatory language at
§ 418.22(b)(3)(iii) to require the
physician’s signature to follow the
narrative attestation statement, rather
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than to be above it on the form. The
commenters believed that the signature
should ‘‘close the loop’’, and that this
placement would be consistent with the
face-to-face attestation requirements. We
agree with the commenters, and are
finalizing this as a change in the
regulation. We do not believe that
moving the signature underneath the
narrative attestation (rather than leaving
it above it) creates any additional
burden to hospices. The estimate of
administrative burden to create the faceto-face attestation includes enough
administrative time for form revision to
cover moving the narrative attestation
signature line.
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 clarified 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 summarizes the burden
estimate associated with these
requirements.
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70457
TABLE 17—ESTIMATED ANNUAL RECORDKEEPING BURDEN
OMB No.
Requirements
0938–1067 ......................
0938–1067 ......................
0938–1067 ......................
Units
418.22(b)(4)
418.22(b)(4)
418.22(b)(5)
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.
We received one comment about the
burden estimate of the hospice face-toface attestation, and one about an
addition to the face-to-face attestation.
Comment: A commenter wrote that
the administrative burden calculated by
CMS did not include the staff time
required to track down these face-to-face
encounters. The administrative cost that
was calculated is not included in the
reimbursement for hospices.
Response: The above mentioned
burden estimate only reflects the burden
associated with any additional required
documentation. In this case, the
additional required documentation is
the attestation of the face-to-face
encounter. Our burden estimate
includes the administrative time to
develop an attestation form as well as
the time that we believe would be
required to revise the hospice’s existing
certification or recertification forms, if
necessary. The requirement as stated in
§ 418.22 pertains to additional
documentation only, that is,
documentation requirements
Responses
3,429 hospices .........................................................
457,382 ≥ 180-day recerts .......................................
1,733,663 All certs. & recerts ..................................
subsequent to the face-to-face
encounter; therefore, the estimate above
does not include any burden associated
with the administrative coordination
and conduct of face-to-face encounters
or tracking the encounters.
E. ICRs Regarding the Home Health Care
CAHPS Survey (HHCAHPS)
As part of the DHHS Transparency
Initiative on Quality Reporting, we are
implementing a process to measure and
publicly report patients’ experiences
with HH care they receive from
Medicare-certified HHAs 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 HH patients to
assess their HH care providers and the
quality of the HH care they received.
Prior to the HHCAHPS, there was no
national standard for collecting data
about HH care patients’ perspectives of
their HH care.
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 § 484.215,
§ 484.230, and § 484.235. The burden
Hour burden
1
1
1
Total
0.50
0.0083333
0.0083333
1,714
3,811
14,447
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 rule, we have included
the burden directly affecting HHAs,
which is the burden to select a survey
vendor from https://www.homehealth
cahps.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 percent of all HHAs (9,890 HHAs of
a total of 10,998 HHAs) would be
conducting HHCAHPS, since about 9
percent 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:
TABLE 18—ESTIMATED ANNUAL BURDEN ON HHAS FOR VENDOR SELECTION
Requirements
Units
Responses
Hour burden
Total
0938–1066
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OMB No.
§ 484.250(c)(2)
9,890
1
16.0
158,240
OMB Number 0938–1066 will be
revised to reflect the update concerning
burden to the HHAs for vendor services
for HHCAHPS.
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
HH market basket percentage increase
will be reduced 2 percentage points. In
accordance with the statue, 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 § 484.225(h) and (i).
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In the CY 2010 HH PPS proposed rule
(August 13, 2009), we to expand the HH
quality measures reporting requirements
to include the CAHPS® 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
HH care using a survey developed by
AHRQ in its CAHPS® program. In the
CY 2010 HH PPS final rule, we stated
our intention to move forward with the
HHCAHPS and link the survey to the
CY 2012 annual payment update under
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the DRA ‘‘pay-for-reporting’’
requirement.
As part of this requirement, each HHA
sponsoring a HHCAHPS Survey must
prepare and submit to its survey vendor
a file containing patient data on patients
served the preceding month that will be
used by the survey vendor to select the
sample and field the survey. This file
(essentially the sampling frame) for
most HHAs 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.
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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–F]
Fax: (202) 395–6974; or
E-mail:
OIRA_submission@omb.eop.gov.
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.
emcdonald on DSK2BSOYB1PROD with RULES2
1. CY 2011 Update
The update set forth in this final 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 $960 million in CY
2011 savings. The $960 million impact
to the proposed CY 2011 HH PPS
reflects the distributional effects of an
updated wage index ($20 million
increase) plus the 1.1 percent HH
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market basket update ($210 million
increase), for a total increase of $230
million. The 3.79 percent case-mix
adjustment applicable to the national
standardized 60-day episode rates ($700
million decrease) plus the 2.5 percent
returned from the outlier provisions of
the Affordable Care Act ($490 million
decrease) results in a total decrease of
$1,190 million, which, when added to
the $230 million increase, totals savings
of $960 million in CY 2011. The $960
million in savings is reflected in the first
row of column 3 of Table 19 below as
a 4.89 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. For the purposes
of the RFA, our updated data show that
approximately 95 percent of HHAs are
considered to be small businesses
according to the Small Business
Administration’s size standards with
total revenues of $13.5 million or less in
any one year. Individuals and States are
not included in the definition of a small
entity. The Secretary has determined
that this final rule would have a
significant economic impact on a
substantial number of small entities. In
the proposed rule, we stated that our
analysis reveals that nominal case-mix
continues to grow under the HH PPS.
Specifically, nominal case-mix has
grown from the 11.75 percent growth
identified in our analysis for CY 2008
rulemaking to 17.45 percent for this
year’s rulemaking. Because we have not
yet accounted for all of the increase in
nominal case-mix, that is case-mix that
is not real (real being related to
treatment of more resource intense
patients), case-mix reductions are
necessary. As such, we believe it
appropriate to reduce the HH PPS rates
now, so as to move towards more
accurate payment for the delivery of HH
services. We have amended the proposal
that would have implemented two
successive years of payment reductions,
with each year’s reduction at 3.79
percent. Instead we are finalizing in this
rule only the first year’s reduction (for
CY 2011) while we study additional
case-mix data, and methods to
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incorporate such data, into our
methodology for measuring real vs.
nominal case-mix change. Other
reductions to HH PPS payments
discussed in this rule were mandated in
provisions in the Affordable Care Act.
Our analysis shows that small HHAs
and large HHAs are impacted relatively
similarly by the final provisions of this
rule. Further detailed impact
assessment, by facility type, is presented
in the analysis below.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 604. For
purposes of section 1102(b) of the Act,
we define a small rural hospital as a
hospital that is located outside of a
metropolitan statistical area and has
fewer than 100 beds. This final rule
applies to HHAs. Therefore, the
Secretary has determined that this final
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 final rule is not
anticipated to have an effect on State,
local, or tribal governments in the
aggregate, or on the private sector, of
$135 million or more.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a final
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 final 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 final 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 final
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
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variables as number of visits or casemix.
This analysis incorporates the latest
estimates of growth in service use and
payments under the Medicare HH
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, 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 19 represents how HHA
revenues are likely to be affected by the
policy changes proposed in this rule.
For this analysis, we used linked HH
claims and OASIS assessments; the
claims represented a 20-percent sample
of 60-day episodes occurring in CY
2008. The first column of Table 19
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 policies
outlined earlier in this rule. For CY
2011, the average impact for all HHAs
is a .08 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 4.89 percent. There is
very little difference in the estimated
impact on HHAs when looking at the
type of facility. Freestanding HHAs are
estimated to see a 4.88 percent decrease
in payments while facility based HHAs
are estimated to see a 4.92 percent
decrease. Similarly, voluntary not-forprofit HHAs are estimated to see a 4.97
percent decrease in payments, while forprofit HHAs are estimated to see a 4.84
percent decrease in payments. Rural
agencies are estimated to see a 4.67
percent decrease in payment in CY
2011, while urban agencies are
estimated to see a 4.93 percent decrease
in payments. Agencies in New England
(¥5.39 percent) and in the South
(¥5.19 percent) are estimated to
experience the largest decreases, while
HHAs in the Pacific (¥4.49 percent)
and the West (¥4.66 percent) are
estimated to have less of a decrease in
payments in CY 2011. In general,
smaller agencies are estimated to see
less of a decrease in payments in CY
2011, than are larger agencies, with
agencies with 100–199 first episodes
estimated to see a 4.73 percent decrease
and agencies with 200 or more first
episodes estimated to see a 4.93 percent
decrease in payment in CY 2011.
70459
We supplemented our impact analysis
from the proposed rule by linking to
Medicare cost report data which has
total revenues for HHAs. Using total
revenues and the $13.5 million
threshold of the RFA, we categorized an
HHA as being either small or large. To
perform this analysis, we were able to
match approximately 72 percent of the
cost report data to our model. For the
remainder of the agencies in the model,
we proxy for large agencies as those
agencies with at least 750 first episodes
(doing so results in approximately 95
percent of agencies being classified as
small and 5 percent of agencies being
large, which is reflective of what our
cost report files show us). This analysis
provides similar results to the one using
first episodes as a measure of an
agency’s size in that small HHAs fare
slightly better, a 4.84 percent decrease
in payments, than do large HHAs,
which are estimated to experience a
5.01 percent decrease in payments in
CY 2011.
Section 3131(c) of the Affordable Care
Act amended section 421(a) of the
MMA. The amended section 421(a) of
the MMA provides an increase of 3
percent of the payment amount
otherwise made for HH 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 addon for all four quarters of CY 2011.
TABLE 19—IMPACTS BY AGENCY TYPE
Comparisons
Percent change
due to the effects
of the updated
wage index only
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Group
0.08
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¥4.99
¥4.85
¥4.97
¥4.95
¥4.68
¥4.86
¥4.88
¥4.92
¥4.97
¥4.84
¥4.92
0.00
0.26
¥0.43
¥0.10
0.20
17NOR2
¥4.89
¥0.10
0.16
¥0.23
¥0.08
0.20
¥0.06
0.10
¥0.05
¥0.09
0.17
¥0.15
All Agencies:
Type of Facility:
Free-Standing/Other Vol/NP .................................................................................................................
Free-Standing/Other Proprietary ..........................................................................................................
Free-Standing/Other Government ........................................................................................................
Facility-Based Vol/NP ...........................................................................................................................
Facility-Based Proprietary ....................................................................................................................
Facility-Based Government ..................................................................................................................
Subtotal: Freestanding ..................................................................................................................
Subtotal: Facility-based .................................................................................................................
Subtotal: Vol/NP ............................................................................................................................
Subtotal: Proprietary ......................................................................................................................
Subtotal: Government ...................................................................................................................
Type of Facility (Rural * Only):
Free-Standing/Other Vol/NP .................................................................................................................
Free-Standing/Other Proprietary ..........................................................................................................
Free-Standing/Other Government ........................................................................................................
Facility-Based Vol/NP ...........................................................................................................................
Facility-Based Proprietary ....................................................................................................................
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Impact of all CY
2011 policies 1
(percent)
¥4.70
¥4.61
¥5.01
¥4.73
¥4.53
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TABLE 19—IMPACTS BY AGENCY TYPE—Continued
Comparisons
Percent change
due to the effects
of the updated
wage index only
Group
Impact of all CY
2011 policies 1
(percent)
¥0.12
¥4.78
¥0.12
0.15
0.02
¥0.07
0.20
0.03
¥5.03
¥4.89
¥4.93
¥5.01
¥4.78
¥4.95
0.10
0.07
¥4.67
¥4.93
¥0.34
0.18
0.01
0.33
¥0.11
¥5.19
¥4.80
¥4.98
¥4.66
¥5.03
¥0.54
¥0.23
0.05
¥0.09
0.41
0.07
¥0.22
¥0.15
0.54
¥0.11
¥5.39
¥5.08
¥4.94
¥5.04
¥4.58
¥4.95
¥5.11
¥5.05
¥4.49
¥5.03
0.21
0.20
0.26
0.25
0.01
¥4.88
¥4.86
¥4.77
¥4.73
¥4.93
0.14
¥0.08
Facility-Based Government ..................................................................................................................
Type of Facility (Urban * Only):
Free-Standing/Other Vol/NP .................................................................................................................
Free-Standing/Other Proprietary ..........................................................................................................
Free-Standing/Other Government ........................................................................................................
Facility-Based Vol/NP ...........................................................................................................................
Facility-Based Proprietary ....................................................................................................................
Facility-Based Government ..................................................................................................................
Type of Facility (Urban* or Rural*):
Rural .....................................................................................................................................................
Urban ....................................................................................................................................................
Facility Location: Region*:
North .....................................................................................................................................................
South ....................................................................................................................................................
Midwest .................................................................................................................................................
West ......................................................................................................................................................
Outlying .................................................................................................................................................
Facility Location:
Area of the Country:
New England ........................................................................................................................................
Mid Atlantic ...........................................................................................................................................
South Atlantic .......................................................................................................................................
East South Central ...............................................................................................................................
West South Central ..............................................................................................................................
East North Central ................................................................................................................................
West North Central ...............................................................................................................................
Mountain ...............................................................................................................................................
Pacific ...................................................................................................................................................
Outlying .................................................................................................................................................
Facility Size: (Number of First Episodes):
< 19 ..............................................................................................................................................................
20 to 49 ........................................................................................................................................................
50 to 99 ........................................................................................................................................................
100 to 199 ....................................................................................................................................................
200 or More .................................................................................................................................................
Facility Size: (estimated total revenue)
Small (estimated total revenue <= $13.5 million) ................................................................................
Large (estimated total revenue > $13.5 million) ..................................................................................
¥4.84
¥5.01
emcdonald on DSK2BSOYB1PROD with RULES2
Note: Based on a 20 percent sample of CY 2008 claims linked to OASIS assessments.
*Urban/rural status, for the purposes of these simulations, is based on the wage index on which episode payment is based. The wage index is
based on the site of service of the beneficiary.
REGION KEY:
New England = Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle Atlantic = Pennsylvania, New Jersey,
New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia;
East North Central = Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Tennessee; West North
Central = Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central = Arkansas, Louisiana, Oklahoma,
Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming; Pacific = Alaska, California, Hawaii, Oregon,
Washington; Outlying = Guam, Puerto Rico, Virgin Islands.
1 Percent change due to the effects of the update wage index, the 1.1 percent HH market basket update, the 3.79 percent reduction to the national standardized episode rates, the national per-visit rates, the LUPA add-on payment amount, the 5 percent decrease in the rates due to the
Affordable Care Act, the new approximate 2.5 percent target for outliers as a percentage of total HH PPS payments, a 0.67 FDL ratio, 10 percent outlier cap, and the 3 percent rural add-on.
In a separate, supplemental analysis,
as merely an indicator of possible access
to care issues, we looked at estimated
margins of HHAs, by county, and the
estimated effect that the provisions of
this rule might have on HHA margins.
We note that predicting the size of the
increase in negative-margin agencies as
a result of this rule is difficult to do
because many agencies may find ways
to cut costs or increase revenues so that
margins do not deteriorate. We also note
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that margin analysis alone is not an
accurate access to care indicator. Many
factors affect whether agencies with low
or negative margin would close or not,
such as the organization’s mission, the
availability of alternate sources of
funding, and whether or not the
organization is embedded in a larger
one.
We performed the following analysis
for the purposes of identifying potential
access risks associated with this rule. In
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particular, we looked to identify
whether the finalized policies of this
rule might increase the number of
counties not served by at least one HHA
with a positive margin. The analysis
demonstrated that the occurrence of
such counties was very infrequent.
Looking further, we also identified that
the counties we identified had at least
one HHA in a contiguous county with
a positive margin. As we have
previously described, we believe HH
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emcdonald on DSK2BSOYB1PROD with RULES2
industry margins are sufficient to
support a rate reduction of this size. We
note here as we have elsewhere in this
rule that MedPac projected 2011
margins would remain high, at 13.7
percent (assuming the previously
planned rate reduction of ¥2.71 percent
in 2011), and MedPAC also reported
that the number of agencies continues to
grow, reaching in excess of 10,400 in
2009, a 50 percent increase since 2002.
We again note that access to care was
not found to be inadequate in 2002,
when the number of agencies nationally
was much lower than it is today. Thus,
we do not believe that the finalized
policies in this rule will result in access
to care issues. We would note that the
above described analysis is an indicator
that access to care will not be an issue
as a result of the provisions of this rule.
C. Alternative Considered
As stated above, in section IV.A. of
this rule, Overall Impact, we estimate
that this final rule would have a
significant economic impact on a
substantial number of small entities. In
the proposed rule, our analysis on the
impact on small HHAs was from an
episodic perspective. As a result of the
public comments received on the
proposed rule, we supplemented our
impact from the proposed rule by
linking to Medicare cost report data,
which has reported total revenues for
HHAs. The results of that supplemental
analysis reveal that in using Medicare
cost report data and a $13.5 million
threshold to determine small versus
large HHAs, the effect on small HHAs is
virtually unchanged from that which
was described in the proposed rule.
In CY 2008 rulemaking, we
promulgated case-mix reductions of
2.75 percent for CY 2008, CY 2009, CY
2010, and 2.71 percent for CY 2011.
Since that rulemaking, our analysis still
shows that case-mix continues to grow.
More specifically, nominal case-mix has
grown from the 11.75 percent growth
identified in our analysis for the CY
2008 rulemaking to 17.45 percent for
this rule. While the 2.71 percent casemix reduction was promulgated in CY
2008 rulemaking, because nominal casemix continues to grow and thus to date
we have not accounted for all of the
increase in nominal case-mix growth,
we believe it appropriate to reduce HH
PPS rates now, so as to move towards
more accurate payment for the delivery
of HH services under the Medicare HH
benefit.
Furthermore, we have amended our
proposal from the proposed rule, which
would have implemented 2 successive
years of case-mix reductions at 3.79
percent, and are instead finalizing only
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one 3.79 percent reduction for CY 2011.
We will study additional case-mix data,
and methods to incorporate such data,
into our methodology for measuring real
versus nominal case-mix change in
future rulemaking.
The other reductions to the HH PPS
payments discussed in this rule and
included in the final provisions of this
rule are not discretionary as they are
required by the Affordable Care Act.
D. 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
final rule.
Table 20 provides our best estimate of
the decrease in Medicare payments
under the HH PPS as a result of the
changes presented in this final rule
based on the best available data. The
expenditures are classified as a transfer
to the Federal Government of $960
million.
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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 amends 42 CFR
chapters IV and V as set forth below:
PART 409—HOSPITAL INSURANCE
TABLE 20—ACCOUNTING STATEMENT: BENEFITS
CLASSIFICATION OF ESTIMATED EX- ■ 1. The authority citation for part 409
PENDITURES, FROM THE 2010 HH continues to read as follows:
PPS CALENDAR YEAR TO THE 2011
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
HH PPS CALENDAR YEAR
1395hh).
Category
Transfers
Annualized Monetized
Transfers.
Negative transfer—
Estimated decrease
in expenditures:
$960 million.
Federal Government
to HH providers.
From Whom to Whom
In conclusion, we estimate that the
net impact of the proposals in this rule
is approximately $960 million in CY
2011 savings. The $960 million impact
to the proposed CY 2011 HH PPS
reflects the distributional effects of an
updated wage index ($20 million
increase), the 1.1 percent HH market
basket update ($210 million increase),
the 3.79 percent case-mix adjustment
applicable to the national standardized
60-day episode rates ($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.
Frm 00091
Fmt 4701
2. Section 409.44 is amended by
revising paragraphs (c)(1), (c)(2)(i),
(c)(2)(iii), and (c)(2)(iv) to read as
follows:
■
§ 409.44
E. Conclusion
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Under Hospital Insurance
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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
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function, and both must be included in
the clinical record. The therapy goals
must be established by a qualified
therapist in conjunction with the
physician.
(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 professional
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 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 professional
standards of clinical practice enabling
comparison of successive measurements
to determine the effectiveness of therapy
goals. Such objective measurements
would be made by the qualified
therapist using measurements which
assess activities of daily living that may
include but are not limited to eating,
swallowing, bathing, dressing, toileting,
walking, climbing stairs, or using
assistive devices, and mental and
cognitive factors.
(2) * * *
(i) The services must be considered
under accepted standards of
professional 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, of
the corresponding discipline for the
type of therapy being provided, using a
method which would include objective
measurement as described in
§ 409.44(c)(1)(iv). If more than one
discipline of therapy is being provided,
a qualified therapist from each of the
disciplines must perform the assessment
and periodic reassessments. The
measurement results and corresponding
effectiveness of the therapy, or lack
thereof, must be documented in the
clinical record.
(B) At least every 30 days a qualified
therapist (instead of an assistant) must
provide the needed therapy service and
functionally reassess the patient in
accordance with § 409.44(c)(2)(i)(A).
Where more than one discipline of
therapy is being provided, a qualified
therapist from each of the disciplines
must provide the needed therapy
service and functionally reassess the
patient in accordance with
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§ 409.44(c)(2)(i)(A) at least every 30
days.
(C) If a patient is expected to require
13 therapy visits, a qualified therapist
(instead of an assistant) must provide all
of the therapy services on the 13th
therapy visit and functionally reassess
the patient in accordance with
§ 409.44(c)(2)(i)(A). Exceptions to this
requirement are as follows:
(1) The qualified therapist’s visit can
occur after the 10th therapy visit but no
later than the 13th therapy visit when
the patient resides in a rural area or
when documented circumstances
outside the control of the therapist
prevent the qualified therapist’s visit at
the 13th therapy visit.
(2) Where more than one discipline of
therapy is being provided, the qualified
therapist from each discipline must
provide all of the therapy services and
functionally reassess the patient in
accordance with § 409.44(c)(2)(i)(A)
during the visit associated with that
discipline which is scheduled to occur
close to but no later than the 13th
therapy visit per the plan of care.
(D) If a patient is expected to require
19 therapy visits, a qualified therapist
(instead of an assistant) must provide all
of the therapy services on the 19th
therapy visit and functionally reassess
the patient in accordance with
§ 409.44(c)(2)(A). Exceptions to this
requirement are as follows:
(1) This required qualified therapist
service can instead occur after the 16th
therapy visit but no later than the 19th
therapy visit when the patient resides in
a rural area or documented
circumstances outside the control of the
therapist preclude the qualified
therapist service at the 19th therapy
visit.
(2) Where more than one discipline of
therapy is being provided, the qualified
therapist from each discipline must
provide the therapy service and
functionally reassess the patient in
accordance with § 409.44(c)(2)(i)(A)
during the visit which would occur
close to but before the 19th visit per the
plan of care.
(E) Pursuant to the requirements
described in paragraphs (c)(2)(i)(A)(B),
(C), and (D) above, subsequent therapy
visits will not be covered until the
following conditions are met:
(1) The qualified therapist has
completed the reassessment and
objective measurement of the
effectiveness of the therapy as it relates
to the 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
PO 00000
Frm 00092
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corresponding therapy effectiveness in
the clinical record in accordance with
§ 409.44(c)(2)(i)(H) of this section.
(F) If the criteria for maintenance
therapy, described at
§ 409.44(c)(2)(iii)(B) and (C) of this
section are not met, the following
criteria must also be met for subsequent
therapy visits to be covered:
(1) If the objective measurements of
the reassessment do not reveal progress
toward goals, the qualified therapist
together with the physician must
determine whether the therapy is still
effective or should be discontinued.
(2) If therapy is to be continued in
accordance with § 409.44(c)(2)(iv)(B)(1)
of this section, the clinical record must
document with a clinically supportable
statement why there is an expectation
that the goals are attainable in a
reasonable and generally predictable
period of time.
(G) Clinical notes written by therapy
assistants may supplement the clinical
record, and if included, must include
the date written, the signature,
professional designation, 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 the
effectiveness of the therapy (or lack
thereof) objectively.
(H) Documentation by a qualified
therapist must include the following:
(1) The therapist’s assessment of the
effectiveness of the therapy as it relates
to the therapy goals;
(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
can continue to progress toward the
treatment goals and is responding to
therapy in a reasonable and generally
predictable period of time; or in the case
of maintenance therapy, the patient is
responding to therapy and can meet the
goals in a 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.
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(1) Material improvement requires
that the clinical record demonstrate that
the patient is making improvement
towards goals when measured against
his or her condition at the start of
treatment.
(2) If an individual’s expected
restorative 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.
(3) When 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, because the services do not
require the performance or supervision
of a qualified therapist, those services
are not to be considered reasonable and
necessary covered therapy services.
(B) The unique clinical condition of a
patient may require the specialized
skills, knowledge, and judgment of a
qualified therapist to design or establish
a safe and effective maintenance
program required in connection with
the patient’s specific illness or injury.
(1) 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.
(2) The maintenance program must be
established by a qualified therapist (and
not an assistant).
(C) The unique clinical condition of a
patient may require the specialized
skills of a qualified therapist to perform
a safe and effective maintenance
program required in connection with
the patient’s specific illness or injury.
Where the clinical condition of the
patient is such that the complexity of
the therapy 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) or the clinical condition of the
patient is such that the complexity of
the therapy services required to
maintain function must be delivered by
the therapist himself/herself (and not an
assistant) in order to ensure the patient’s
safety and to provide an effective
maintenance program, then those
reasonable and necessary services shall
be covered.
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(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, such as
factors that may result in providing
more services than are typical for the
patient’s condition, those factors must
be documented 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 progress
towards goals 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) Maintenance therapy as described
in § 409.44(c)(2)(iii)(B) or (C) is needed.
PART 418—HOSPICE CARE
3. The authority citation for part 418
continues to read as follows:
■
Authority: Secs 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
Subpart B—Eligibility, Election and
Duration of Benefits
4. Section 418.22 is amended by—
A. Revising paragraphs (a)(3) and
(b)(3)(iii).
■ B. Adding paragraphs (a)(4), (b)(3)(v),
(b)(4), and (b)(5).
The revisions and additions read as
follows:
■
■
§ 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 have a
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70463
face-to-face encounter with each
hospice patient, whose total stay across
all hospices is anticipated to reach the
3rd benefit period, no more than 30
calendar days prior to the 3rd benefit
period recertification, and must have a
face-to-face encounter with that patient
no more than 30 calendar days prior to
every recertification thereafter, to gather
clinical findings to determine continued
eligibility for hospice care.
(b) * * *
(3) * * *
(iii) The narrative shall include a
statement directly above the physician
signature attesting that by signing, the
physician confirms that he/she
composed the narrative based on his/her
review of the patient’s medical record
or, if applicable, his/her examination of
the patient.
*
*
*
*
*
(v) The narrative associated with the
3rd benefit period 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-toface encounter with the patient
described in (a)(4), 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).
Subpart B—Certification and Plan
Requirements
■
■
6. Section 424.22 is amended by—
A. Adding paragraph (a)(1)(v).
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B. Revising paragraph (a)(2), (b)(1),
and (d).
The revisions and additions read as
follows:
■
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§ 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 90 days prior to the home
health start of care date or within 30
days 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 § 409.42(a) and (c)
respectively. Under 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 nonphysician 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 90 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
nonphysician practitioner within the 90
days prior to the start of the home
health episode, the certifying physician
or nonphysician practitioner must have
a face to face encounter with the patient
within 30 days 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
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Medicare telehealth services established
by the applicable physician fee schedule
regulation.
(D) 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 faceto-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 § 409.42(a) and (c)
respectively. The documentation must
be clearly titled, dated and signed by the
certifying physician.
(2) Timing and 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
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
§ 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.
(1) If a physician has a financial
relationship as defined in § 411.354 of
this chapter, with an HHA, the
physician may not certify or recertify
need for home health services provided
by that HHA, establish or review a plan
of treatment for such services, or
conduct the face-to-face encounter
required under sections 1814(a)(2)(C)
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and 1835(a)(2)(A) of the Act unless the
financial relationship meets one of the
exceptions set forth in § 411.355
through § 411.357 of this chapter.
(2) A Nonphysician practitioner may
not perform the face-to-face encounter
required under sections 1814(a)(2)(C)
and 1835(a)(2)(A) of the Act if such
encounter would be prohibited under
paragraph (d)(i) if the nonphysician
practitioner were a physician.
Subpart P—Requirements for
Establishing and Maintaining Medicare
Billing Privileges
7. Section 424.502 is amended by
adding the definition of ‘‘Change in
Majority Ownership’’ in alphabetical
order to read as follows:
■
§ 424.502
Definitions.
*
*
*
*
*
Change in Majority Ownership occurs
when an individual or organization
acquires more than a 50 percent direct
ownership interest in an HHA during
the 36 months following the HHA’s
initial enrollment into the Medicare
program or the 36 months following the
HHA’s most recent change in majority
ownership (including asset sale, stock
transfer, merger, and consolidation).
This includes an individual or
organization that acquires majority
ownership in an HHA through the
cumulative effect of asset sales, stock
transfers, consolidations, or mergers
during the 36-month period after
Medicare billing privileges are conveyed
or the 36-month period following the
HHA’s most recent change in majority
ownership.
*
*
*
*
*
■ 8. Section 424.510 is amended by
adding paragraph (d)(9) to read as
follows:
§ 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 agency
must satisfy the home health ‘‘initial
reserve operating funds’’ requirement as
set forth in § 489.28 of this chapter.
*
*
*
*
*
■ 9. Section 424.530 is amended by
adding paragraph (a)(8)to read as
follows:
§ 424.530 Denial of enrollment in the
Medicare program.
(a) * * *
(8) Initial Reserve Operating Funds. (i)
CMS or its designated Medicare
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contractor may deny Medicare billing
privileges if, within 30 days of a CMS
or Medicare contractor request, a home
health agency (HHA) cannot furnish
supporting documentation which
verifies that the HHA meets the initial
reserve operating funds requirement
found in § 489.28(a) of this title.
(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:
§ 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 an 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:
§ 424.550 Prohibitions on the sale or
transfer of billing privileges.
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*
*
*
*
*
(b) * * *
(1) Unless an exception in (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, and
consolidations) within 36 months after
the effective date of the HHA’s initial
enrollment in Medicare or within 36
months after the HHA’s most recent
change in majority ownership, 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 (initial) HHA under the
provisions of § 424.510 of this subpart.
(ii) Obtain a State survey or an
accreditation from an approved
accreditation organization.
(2)(i) The HHA submitted two
consecutive years of full cost reports.
For purposes of this exception, low
utilization or no utilization cost reports
do not qualify as full cost reports.
(ii) An HHA’s parent company is
undergoing an internal corporate
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restructuring, such as a merger or
consolidation.
(iii) The owners of an existing HHA
are changing the HHA’s existing
business structure (for example, from a
corporation to a partnership (general or
limited); from an LLC to a corporation;
from a partnership (general or limited)
to an LLC) and the owners remain the
same.
(iv) An individual owner of an HHA
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 Home Health Agencies
13. Section 484.250 is revised to read
as follows:
■
§ 484.250
Patient assessment data.
(a) An HHA must submit to CMS the
OASIS–C data described at § 484.55
(b)(1) and Home Health Care CAHPS
data in order for CMS to administer the
payment rate methodologies described
in § 484.215, § 484.230, and § 484.235 of
this subpart, 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 2
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.
(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
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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).
Subpart B—Essentials of Provider
Agreements
15. Section 489.28 is amended by—
A. Revising paragraphs (a) and (g).
B. Adding paragraph (c)(1).
C. Reserving paragraph (c)(2).
The addition and revisions read as
follows:
■
■
■
■
§ 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 up to the expiration of the 3month period following the conveyance
of Medicare billing privileges 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. When selecting cost reports
for the comparative analysis, CMS will
exclude low utilization or no utilization
cost reports.
(2) [Reserved.]
*
*
*
*
*
(g) Billing Privileges. (1) CMS may
deny Medicare billing privileges to an
HHA unless the HHA meets the initial
reserve operating funds requirements of
this section.
(2) CMS may revoke the Medicare
billing privileges of an HHA that fails to
maintain and comply with the initial
reserve operating funds requirements of
this section for the three-month period
after it receives its Medicare billing
privileges.
Authority: (Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
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Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: October 26, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: October 29, 2010.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
Note: The following addenda will not be
published in the Code of Federal Regulations.
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[FR Doc. 2010–27778 Filed 11–2–10; 4:15 pm]
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70486
Agencies
[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Rules and Regulations]
[Pages 70372-70486]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27778]
[[Page 70371]]
-----------------------------------------------------------------------
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Center for Medicare & Medicaid Services
-----------------------------------------------------------------------
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; Final Rule
Federal Register / Vol. 75 , No. 221 / Wednesday, November 17, 2010 /
Rules and Regulations
[[Page 70372]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409, 418, 424, 484, and 489
[CMS-1510-F]
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule sets 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
nonroutine 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 updates the wage index used under the HH PPS and, in
accordance with the Patient Protection and Affordable Care Act of 2010
(Affordable Care Act), updates the HH PPS outlier policy. In addition,
this rule revises the home health agency (HHA) capitalization
requirements. This rule further adds clarifying language to the
``skilled services'' section. The rule finalizes a 3.79 percent
reduction to rates for CY 2011 to account for changes in case-mix,
which are unrelated to real changes in patient acuity. Finally, this
rule incorporates new legislative requirements regarding face-to-face
encounters with providers related to home health and hospice care.
DATES: Effective Date: These regulations are effective on January 1,
2011.
FOR FURTHER INFORMATION CONTACT:
Frank Whelan, (410) 786-1302, for information related to payment
safeguards.
Elizabeth Goldstein, (410) 786-6665, for CAHPS issues.
Mary Pratt, (410) 786-6867, for quality issues.
Randy Throndset, (410) 786-0131, for overall HH PPS issues.
Kathleen Walch, (410) 786-7970, for skilled services requirements and
clinical issues.
Table of Contents
I. Background
A. Statutory Background
B. System for Payment of Home Health Services
C. Updates to the HH PPS
D. Comments Received
II. Provisions of the Proposed Rule and Response to Comments
A. Case-Mix Measurement
B. Therapy Clarifications
C. Outlier Policy
1. Background
2. Regulatory Update
3. Statutory Update
4. Outlier Cap
5. Loss Sharing Ratio and Fixed Dollar Ratio (FDL)
6. Imputed Costs
D. CY 2011 Rate Update
1. Home Health Market Basket Update
2. Home Health Care Quality Improvement
a. OASIS
b. Home Health Care CAHPS Survey (HHCAHPS)
3. Home Health Wage Index
4. CY 2011 Annual Payment Update
a. National Standardized 60-Day Episode Rate
b. Updated CY 2011 National Standardized 60-Day Episode Payment
Rate
c. National Per-Visit Rates Used to Pay LUPAs and Compute
Imputed Costs Used in Outlier Calculations
d. LUPA Add-on Payment Amount Update
e. Nonroutine Medical Supply Conversion Factor Update
5. Rural Add-on
E. Enrollment Provisions for HHAs
1. HHA Capitalization
2. HHA Changes of Ownership
F. Home Health Face-to-Face Encounter
G. Future Plans to Group HH PPS Claims Centrally During Claims
Processing
H. New Requirements Affecting Hospice Certifications and
Recertifications
III. Collection of Information Requirements
IV. Regulatory Impact Analysis
SUPPLEMENTARY INFORMATION:
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 (HH) services. Section 4603 of the BBA mandated
the development of the home health prospective payment system (HH PPS).
Until the implementation of an 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 an HH PPS
for all Medicare-covered HH 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 an HH PPS for all costs of HH services paid
under Medicare.
Section 1895(b)(3)(A) of the Act requires the following: (1) The
computation of a standard prospective payment amount includes all costs
for HH 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 HH 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 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 HH services
furnished in a geographic area compared to the applicable national
average level. Under section 1895(b)(4)(C) of the Act, 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
Patient Protection and Affordable Care Act of 2010 (The Affordable Care
Act) (Pub. L. 111-148, enacted on March 23, 2010) 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) of the
Affordable Care Act revised section 1895(b)(5) of the Act so that the
standard payment amount is reduced by 5 percent and the total outlier
payments in a given fiscal year (FY) or year may not exceed 2.5 percent
of total payments projected or estimated. The provision also makes
permanent a 10 percent agency level outlier payment cap.
In accordance with the statute, as amended by the BBA, we published
a final rule in the July 3, 2000 Federal Register (65 FR 41128) to
implement the
[[Page 70373]]
1997 HH PPS legislation. The July 2000 final rule established
requirements for the new HH PPS for HH 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 an HH PPS for HH 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 HH 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).
Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L.
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v)
to the Act, requiring HHAs to submit data for purposes of measuring
health care quality, and links the quality data submission to the
annual applicable percentage increase. This data submission requirement
is applicable for CY 2007 and each subsequent year. If an HHA does not
submit quality data, the HH market basket percentage increase is
reduced 2 percentage points. In the November 9, 2006 Federal Register
(71 FR 65884, 65935), we published a final rule to implement the pay-
for-reporting requirement of the DRA, which was codified at Sec.
484.225(h) and (i) in accordance with the statute.
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 of 2003 (MMA) (Pub. L. 108-173,
enacted on December 8, 2003) as amended by section 5201(b) of the DRA.
The amended section 421(a) of the MMA now requires, for HH 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 based on 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 HH disciplines (skilled nursing, HH
aide, physical therapy, speech-language pathology, occupational
therapy, and medical social services). Payment for nonroutine medical
supplies (NRS) is no longer part of the national standardized 60-day
episode rate and is computed by multiplying the relative weight for a
particular NRS severity level by the NRS conversion factor (See section
III.C.4.e. of this final rule). Payment for durable medical equipment
covered under the HH 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 based on a
national per-visit rate by discipline; an episode consisting of four or
fewer visits within a 60-day period receives what is referred to as a
low utilization payment adjustment (LUPA). Medicare also adjusts the
national standardized 60-day episode payment rate for certain
intervening events that are subject to a 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.
The 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.
That rule included an analysis performed on CY 2005 HH claims data,
which 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. Subsequently, a more detailed
analysis was performed on the 12.78 percent increase in case-mix to
evaluate if any portion of the increase was associated with a change in
the actual clinical condition of HH patients. We examined data on
demographics, family severity, and non-HH Part A Medicare expenditure
data to predict the average case-mix weight for 2005. As a result of
the subsequent detailed analysis, we recognized that an 11.75 percent
increase in case-mix was due to changes in coding practices and
documentation, and not 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 2.75 percent
per year for 3 years beginning in CY 2008 and 2.71 percent for the
fourth year in CY 2011. We indicated that we 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.
For CY 2010, we published a final rule in the November 10, 2009
Federal Register (74 FR 58077) (hereinafter referred to as the CY 2010
HH PPS final rule) that sets forth the update to the 60-day national
episode rates and the national per-visit rates under the Medicare
prospective payment system for HH services.
D. Comments Received
In response to the publication of the CY 2011 HH PPS proposed rule,
we received approximately 500 items of correspondence from the public.
We received numerous comments from various trade associations and major
health-related organizations. Comments also originated from HHAs,
hospitals, other providers, suppliers, practitioners, advocacy groups,
consulting firms, and private citizens. The following discussion,
arranged by subject area, includes our responses to the comments, and
where appropriate, a brief summary as to whether or not we are
implementing the proposed provision or some variation thereof.
General (Miscellaneous)
Comment: A commenter stated that multiple policy changes and
payment reductions have led to the industry's inability to apply
``cause-and-effect'' analysis when HH care access becomes critical. The
commenter recommends applying changes one at a time and phasing them in
to allow time to determine the impact of those individual changes.
Another commenter stated that as an HHA owner, she is
[[Page 70374]]
willing to accept cuts to the Medicare HH benefit but that the cuts
need to be incremental so agencies have the time and the resources to
implement adjustments in response to payment changes. In addition,
there is the growing concern of the ``unknown'' costs associated with
implementation of the Affordable Care Act. Another commenter stated
that the health insurance costs for their employees have skyrocketed
over the past 3 years, and that in conjunction with these cuts, it
hinders their ability to hire staff.
Response: We have, in fact, been phasing in the reductions to the
HH PPS rates for the increase in nominal case-mix. As a result of the
CY 2008 final rule, we have reduced HH PPS rates by 2.75 percent for
2008, 2009, and 2010 to account for the increase in nominal case-mix,
that is an increase in case-mix not due to actual changes in patient
characteristics. However, there still exists significant nominal case-
mix increase in the payment system that has not yet been addressed.
Consequently, we believe that the case-mix adjustments continue to be
necessary in order to address the residual increase in the nominal
change in case-mix that has not yet been accounted for in the payment
system. As such, we are moving forward with phasing in our case-mix
reductions and will be applying a 3.79 percent reduction to the HH PPS
rates in CY 2011 (as discussed in the July 23, 2010 proposed rule). In
response to comments that we received on our case-mix model and its
measurement of real case-mix, we will further study the concerns raised
and are not finalizing the proposed 3.79 percent reduction to the HH
PPS rates for CY 2012 at this time. Therefore, in addition to our
continuous monitoring of nominal case-mix increase, we plan to perform
a review of our case-mix and NRS models, and address any reductions to
the CY 2012 HH PPS payments in next year's rulemaking. The other policy
changes and reductions addressed in this rule (that is, outlier
provisions and reductions to the market basket update) were mandated by
the Affordable Care Act. We are uncertain of the meaning of ``unknown''
costs as referenced by the commenter and therefore are unable to
address the particular concern.
Comment: A commenter stated that he receives calls from providers
who are confused with the language that is used by CMS in determining
billing requirements. He believes the proposed changes are a step in
the right direction.
Response: We appreciate the comment and will continue to work
towards providing the industry/public with clear policies,
instructions, and guidance as they relate to our payment policies.
Comment: With the increased use of technology and telehealth, funds
should be made available to HHAs to include such monitoring to allow
patients and their families to be more proactive in the management of
their illnesses and to reduce ER visits, primary care physician
appointments and hospital stays. Home Health is the area to fund, not
to cut, and that medical spending in other areas should be reduced.
Response: We are not opposed to improvements in technology, or the
use of telehealth in the HH setting and certainly do not discourage the
use of these advances in medicine. However, under section 1895(e) of
the Act, telehealth services cannot substitute for in-person HH
services ordered as part of a plan of care. However, telehealth can be
used to supplement traditional HH services.
Section 1895(b)(3)(B) of the Act dictates how HH PPS rates are to
be updated annually, and section 3131(a) of the Affordable Care Act,
amending this provision, requires the Secretary to rebase HH payments
beginning in 2014. At that time, more up-to-date costs will be used to
rebase payments to HHAs.
Comment: A commenter stated that the impact analysis in the
proposed rule is useless in that the analysis simply quantifies the
percentage cut in rates on a geographic basis. Further, the impact
analysis offers little substantive understanding of the individual cost
impact of such proposed provisions as the physician face-to-face
encounter requirement, the revisions to therapy assessment, coverage
and documentation standards, coding change proposals, and CAHPS
compliance. The estimated costs are vastly understated because they do
not include the sizeable administrative expenses that HHAs will incur
to implement any of the changes beyond the cost of some of the form
revisions.
A valid and useful impact analysis starts with an understanding of
the results of the combination of rate cuts and cost increases that the
proposed policies will bring to HHAs. The commenter further asserts
that once these results are fairly and accurately determined, the
impact analysis must begin with the highest of priority concerns--
impact on access to care--as that is the central purpose of Medicare.
Second, the commenter believes that the impact analysis should continue
with an evaluation of the effect of the proposed policies on total
spending for the Medicare program, not just the effect on HH services
spending.
The commenter provided the example that if the analysis of the
proposed policies' impact on access to care shows that thousands of
Medicare beneficiaries would no longer have HH care available or that
provision of HH services would be significantly delayed, Medicare
spending would rise as a result of a shift to higher cost care such as
skilled nursing facility services or extended inpatient stays.
The commenter also proposed that the impact analysis should
evaluate the impact of the proposed policies on another stakeholder--
HHAs as businesses. Such evaluation should start with the ongoing
viability of the individual businesses and the industry as a whole.
Among the many elements that should be reviewed is whether the business
will be paid less than the cost of the delivery of care. Another
element is the workforce impact--will health care workers take their
talents to other care sectors because of reductions in compensation and
benefits. Access to capital is also an important factor to evaluate. If
the proposed rule changes restrict access to capital, there may be
reduced use of efficiency-related technologies or business expansions
to achieve economies of scale. Lack of access to capital could also
mean an inability to meet ongoing payroll obligations because of cash
flow problems.
The commenter also claimed there is another flaw in the CMS impact
analysis, which is its limited review to a single year. This is
particularly concerning to the commenter because the proposed rule
extends rate cuts into a second year. An impact analysis that does not
evaluate the impact of cuts in payment rates for both of the years as
proposed is invalid and in violation of CMS obligations under the
Regulatory Flexibility Act.
The commenter strongly recommends that CMS conduct a thorough and
valid impact analysis, consistent with the concerns referenced above.
Another commenter states that in the proposed rule CMS concluded that
the proposed rule would not have a significant impact on a substantial
number of small entities. Section 605 of the Regulatory Flexibility Act
(RFA) requires that if the regulatory agency certifies that the rule
will not have a significant impact on a substantial number of small
businesses, it must include a statement providing the factual basis
supporting the certification. The commenter suggests that CMS failed to
provide an adequate factual basis for its certification that there
would be no significant impact. In fact, there is no language in the
RFA section of the proposed rule that
[[Page 70375]]
discloses the reasons why CMS concluded that there would be no
substantial impact on small HHAs. CMS should at a minimum have provided
the public with information on the number of HHAs and other health care
entities likely to be affected by the rule. Further, CMS has guidelines
(usually based on small business revenues) in place that the agency
uses to determine whether a rule will have a significant impact on a
substantial number of small entities. CMS failed to discuss how the
impacts of this rule fall within those guidelines. Such a discussion is
vital for the purposes of transparency, as affected small entities can
use this information to provide CMS with economic impact information on
the rule's projected impact on their business. Based on the public
input, the commenter asserts that CMS could determine the validity of
their decision to certify the rule in the publication of the final
regulation.
The commenter is concerned that while CMS has certified that the
rule will not have a significant impact, the affected HHAs still
believe that the regulation will result in a significant burden on
their businesses. The commenter believes that there is merit in
bringing these small business concerns to the attention of CMS in the
hope that they will add to the transparency of the RFA contained in the
final rule.
Response: The RFA requires agencies to analyze options for
regulatory relief of small entities, if a rule has a significant impact
on a substantial number of small entities for that year. As such, there
is no requirement under the RFA to provide impacts for any year(s)
beyond that which the rule is updating the rates. For purposes of the
RFA, small entities include small businesses, nonprofit organizations,
and small governmental jurisdictions. Most hospitals and most other
providers and suppliers are small entities, either by nonprofit status
or by having revenues of $7 million to $34.5 million in any 1 year. For
purposes of the RFA, approximately 95 percent of HHAs are considered
small businesses according to the Small Business Administration's size
standards, with total revenues of $13.5 million or less in any one
year. Individuals and States are not included in the definition of a
small entity. As such, this rule is estimated to have an overall
negative effect upon small entities (see section IV.B. of this final
rule, ``Anticipated Effects'', for supporting analysis).
The last section of Table 19 shows the percentage change in
payments by agency size, as determined by the number of first episodes.
The agency size categories, for this rule, are based on the number of
first episodes in a random 20 percent beneficiary sample of CY 2008
claims data. Initial episodes, under the HH PPS, are defined as the
first episode in a series of adjacent episodes (contiguous episodes
that are separated by no more than a 60-day period between episodes)
for a given beneficiary. Initial, or first, episodes are a good
estimate of agency size, because this method approximates the number of
admissions experienced by the agency based on approximately one-fifth
of the total annual data. The size categories were set to have roughly
equal numbers of agencies, except that the highest category has
somewhat more agencies because added detail amongst the large size
category was not needed.
Because our model does not have the data to account for the
``total'' revenue of an HHA, in the proposed rule, and again in this
final rule, we have used the number of first episodes as a proxy for
agency size. As such, using the facility size categories (based on the
number of first episodes), the impact table shows that the difference
in impact between smaller and larger HHAs is small and within a 0.05
percentage point range. In fact, smaller agencies have a smaller
reduction and fare slightly better than larger agencies represented by
the ``200 or more first episodes'' category.
In an effort to better demonstrate the impact on small HHAs, as it
relates to total revenue, we supplemented our impact analysis by
linking to Medicare cost report data, which has total revenues for
HHAs. Using total revenues and the $13.5 million threshold of the RFA,
we categorized an HHA as being either small or large. To perform this
analysis, we were able to match approximately 72 percent of the cost
report data to our model. For the remainder of the agencies in the
model, we proxy for large agencies as those agencies with at least 750
first episodes. This results in approximately 95 percent of agencies
being classified as small and 5 percent of agencies being large, which
is reflective of what our cost report files show us. This analysis
provides similar results to the one using first episodes as a measure
of an agency's size in that small HHAs fare slightly better, -4.84
percent impact, than do large HHAs, which are estimated to experience a
-5.01 percent (see section IV.B. of this final rule, ``Anticipated
Effects'', for supporting analysis).
In a separate, supplemental analysis, as merely an indicator of
possible access to care issues, we looked at estimated margins of HHAs,
by county, and the estimated effect that the provisions of this rule
might have on HHAs. In particular, we look to identify counties that
might not be served by at least one HHA with a positive margin as a
result of the finalized policies of this rule. The analysis demonstrate
that occurrence of such counties is very infrequent; thus, we do not
believe that access to care is an issue (see section IV.B. of this
final rule, ``Anticipated Effects'', for supporting analysis). Given
the profit margins of HHAs that we and MedPAC are seeing in our
analyses, we believe that the reductions of this final rule can be
absorbed by the majority of HHAs, and that access to care will not be
compromised. However, we will continue to monitor the situation to
identify any unintended consequences of our policies in this final
rule.
Comments Regarding Access to Care
Comment: A commenter stated that additional regulatory
responsibilities of oversight, documentation, education, choosing
survey vendors, etc., would result in increased costs to HHAs. There is
an inherent risk for decreased quality of care and volume of services
provided by HHAs. It is possible that HHAs may become more selective in
their acceptance of medically difficult patients who are likely to
utilize more services.
Response: We assume that the commenter is referring to the therapy
provisions of this rule. We believe that our clarifications to our
therapy coverage requirements do not constitute additional
responsibilities, but rather clarify the existing responsibilities of
the qualified therapist and the HHA. Similarly, we are clarifying the
existing supervision/oversight requirements of qualified therapists in
the HH setting. We are also clarifying our coverage requirements for
education of the patient and/or family members, and our documentation
requirements. We do not consider any of these clarifications to be
beyond the current responsibilities of an HHA.
We are, as part of this final rule, requiring qualified therapists
to perform the needed therapy service, assess patients and measure and
document therapy effectiveness at what we consider key points of the
episode. We believe that all HH patients who need therapy services
would benefit from those services being delivered by a qualified
therapist, instead of an assistant, at key points in the course of
treatment. We will continue to monitor for unintended consequences of
the provisions of this final rule.
Comment: Several commenters stated that the payment reductions
would result in decreased access to care and force HHAs out of
business. The
[[Page 70376]]
commenters assert that patients who are moved from acute care
facilities to their homes and have major medical problems would not be
able to get HH services for their illnesses. These proposed changes
would not only endanger access to care but also impede efforts to
transition patients to the home and cripple essential community HHAs.
Several commenters stated that HH patients would be forced into costly
institutional care and increase Medicare spending. Another commenter
stated that if these proposed cuts were implemented, many senior
citizens who have paid taxes in to the Medicare system for years would
be forced to go into assisted living facilities and nursing homes or
simply not receive the healthcare they deserve. In addition, their
quality of life would be compromised.
Response: As discussed in a previous response to a comment, in a
separate analysis in the regulatory impact section of this rule, we
looked at margins of HHAs, by county, and the estimated effect that the
provisions of this rule would have on HHAs. In particular, we studied
the number of counties that would not be served by at least one HHA
with a positive margin. Our analysis concluded that there were few
counties in which no HHAs had positive margins; therefore, we do not
believe that access to care will be adversely affected by these case-
mix adjustments. Given the data on profit margins that we and MedPAC
saw in our analyses, we believe that the reimbursement rate reductions
set forth in this final rule can be absorbed by the majority of HHAs,
and that access to care will not be compromised.
II. Provisions of the Proposed Rule and Response to Comments
A. Case-Mix Measurement
As stated in the proposed rule published on July 23, 2010, analysis
of HH PPS claims shows total average case-mix grew at a rate of about 1
percent each year from 2000 to 2007, with 4 percent growth in 2008.
Based on our analysis of the proportion of total case-mix change due to
changes in real case-mix severity of the HH user population, the total
amount of case-mix growth unrelated to real changes in patient severity
(nominal case-mix) is 17.45 percent between 2000 and 2008. In each of
the years 2008, 2009, and 2010, we reduced payment rates by 2.75
percent as recoupment for nominal case-mix change. A payment-rate
reduction of 7.43 percent would be needed to account for the
outstanding amount of nominal case-mix change we intend to recoup based
on the real case-mix change analysis updated through 2008. In the
proposed rule, we proposed to increase the planned 2.71 percent
reduction in CY 2011 to 3.79 percent, and to make another 3.79 percent
reduction in CY 2012. Doing so would enable us to account for the 7.43
percent nominal case-mix residual, while minimizing access to care
risks. Iteratively implementing the case-mix reduction over two years
gives HH providers more time to adjust to the intended reduction of
7.43 percent than would be the case were we to account for the residual
in a single year.
For a complete description of the proposed case-mix refinements
model and the underlying research, we refer readers to the CY 2011 HH
PPS proposed rule (75 FR 43238 through 43244) published in the July 23,
2010, Federal Register.
Comment: Commenters stated that we should suspend or drop case-mix
reductions because the proposal is based on the assumption that
agencies intentionally gamed the system.
Response: As we have stated in previous regulations, changes and
improvements in coding are important in bringing about nominal coding
change. We believe nominal coding change results mostly from changed
coding practices, including improved understanding of the ICD-9 coding
system, more comprehensive coding, changes in the interpretation of
various items on the OASIS and in formal OASIS definitions, and other
evolving measurement issues. Our view of the causes of nominal coding
change does not emphasize the idea that HHAs in general gamed the
system. However, since our goal is to pay increased costs associated
with changes in patient severity, and nominal coding change does not
necessarily demonstrate that underlying changes in patient severity
occurred, we believe it is necessary to recoup overpayments due to
nominal coding change.
Comment: Commenters stated that all of the HHAs are being penalized
for the corrupt actions of a few HHAs. Many commenters indicated that
their agency had case-mix weights below the national average.
Commenters stated that nominal case-mix change reductions should be
limited to certain types of agencies (for example, those with high
average case-mix index (CMI) or large weight increases or for-profit
providers) or that CMS should implement different payment reductions by
state or by geographical region, suggesting that their region has a
lower nominal case-mix change than the national average. Other
commenters recommended that reductions be proportional to an individual
agency's CMI. For example, some commenters suggested that payment
reductions be applied to those HHAs with an average case-mix above
1.20. Commenters stated that we should not implement payment reductions
to all HHAs merely because that policy is easier to implement.
Response: For a variety of reasons, as we have noted in previous
regulations, we have not proposed targeted reductions for nominal case-
mix change. We have not conducted analysis of how and whether
individual agencies' coding practices have changed over time because
this is not feasible. One reason is that many agencies have small
patient populations, which would make it practically impossible to
measure nominal case-mix change reliably. Another reason is that we
believe changes and improvements in coding have been widespread, so
that such targeting would likely not separate agencies clearly into
high and low coding-change groups.
Table 1A shows average case-mix by type of agency in 2000 and 2008.
All types of agencies, regardless of region or profit status or size or
affiliation, have substantial increases in their average case-mix.
While for-profit agencies' case-mix grew approximately 19 percent, the
case-mix average for non-profit agencies also grew considerably (16.6
percent). Case-mix grew just over 19.5 percent for freestanding
agencies while case-mix for facility-based agencies grew just short of
15 percent. For rural agencies, case-mix grew almost 16 percent, while
case-mix for urban agencies grew just under 19 percent. Rural agencies
will receive an additional 3 percent rural add-on to their payments,
which will help offset the case-mix reductions. It should be noted that
the agency groups start from different base year values, but in general
the percentage change in case-mix is roughly similar across these
groups, with the possible exception of the Midwest, for which the
percentage change is somewhat higher than the other changes--about 23
percent. No group could be said to have trivial case-mix change.
Therefore, we believe our proposal to make across the board payment
reductions is consistent with the data, and making distinctions by type
of agency would be inappropriate.
[[Page 70377]]
Table 1A--Estimates of Case-Mix Change by Provider Type
[2000-2008]
----------------------------------------------------------------------------------------------------------------
Actual case-mix Case-mix change
---------------------------------------------------------------
2000 (IPS
period) 2008 Total Percentage
----------------------------------------------------------------------------------------------------------------
Overall
----------------------------------------------------------------------------------------------------------------
All Agencies.................................... 1.0959 1.3085 0.2126 19.4
----------------------------------------------------------------------------------------------------------------
Ownership Type
----------------------------------------------------------------------------------------------------------------
Non-profit...................................... 1.0840 1.2641 0.1801 16.6
Government...................................... 1.0672 1.2291 0.1619 15.2
For-profit...................................... 1.1202 1.3332 0.2130 19.0
----------------------------------------------------------------------------------------------------------------
Agency Type
----------------------------------------------------------------------------------------------------------------
Facility-based.................................. 1.0834 1.2433 0.1599 14.8
Freestanding.................................... 1.1035 1.3200 0.2165 19.6
----------------------------------------------------------------------------------------------------------------
Region
----------------------------------------------------------------------------------------------------------------
North........................................... 1.0422 1.2459 0.2037 19.6
South........................................... 1.1251 1.337 0.2118 18.8
Midwest......................................... 1.0865 1.3431 0.2566 23.6
West............................................ 1.0956 1.2648 0.1692 15.5
----------------------------------------------------------------------------------------------------------------
Facility Size (Number of 1st Episodes)
----------------------------------------------------------------------------------------------------------------
< 99 episodes................................... 1.0898 1.2499 0.1602 14.7
100 or more..................................... 1.1057 1.3266 0.2209 20.0
----------------------------------------------------------------------------------------------------------------
Urban/Rural
----------------------------------------------------------------------------------------------------------------
Urban........................................... 1.1097 1.3184 0.2087 18.8
Rural........................................... 1.0478 1.2136 0.1657 15.8
----------------------------------------------------------------------------------------------------------------
Although we have stated in past regulations that a targeted system
would be administratively burdensome, the reasons we have just
presented go beyond administrative complexity. Certain comments seem to
assume that the level of case-mix can precisely identify those agencies
practicing abusive coding. We do not agree with the comments, which
seem to assume that agency-specific case-mix levels can precisely
differentiate agencies practicing abusive coding from others. System
wide, case-mix levels have risen over time while patient
characteristics data indicate little change in patient severity over
time. That is, the main problem is the amount of change in the billed
case-mix weights not attributable to underlying changes in actual
patient severity. Moreover, we believe that a policy of varying payment
levels according to regional differences in nominal case-mix change
would be perceived as inequitable by beneficiaries. That is,
beneficiaries who might have access only to agencies subject to larger
payment reductions might believe Medicare's policies disadvantage them
unfairly.
Comment: Commenters stated that we should suspend or drop case-mix
adjustments because they will cause financial distress/bankruptcy among
agencies, particularly ``safety-net'' agencies that take patients other
agencies reject. Commenters further stated that the proposed payment
reductions will cause ``safety net'' providers to have a ``negative
operating margin'' and/or cause not-for-profit agencies to go out of
business.
Response: Our analysis of the potential effect of the 2011 payment
rate reductions suggests that while negative-margin agencies may
increase in number, almost all such agencies are located in counties
with other agencies predicted to have positive margins. We also note
that predicting the size of the increase in negative-margin agencies is
difficult to do because many agencies may find ways to cut costs or
increase revenues so that margins do not deteriorate. Identifying the
agencies that commenters call ``safety-net'' agencies is not feasible
with our administrative data, so we cannot provide any evidence either
to support or refute assertions that safety-net agencies are at
greatest risk. Our analysis of margins of not-for-profit agencies shows
that they tend to have lower margins than for-profit agencies. However,
we do not agree that not-for-profit agencies will necessarily be more
likely to exit the HH business than a for-profit agency. We believe the
business decision is a complex one with many considerations, such as
the organization's mission, the availability of alternate sources of
funding, and whether or not the organization is embedded in a larger
one. These influential factors are not necessarily associated with the
non-profit or for-profit status of an agency, and therefore, we cannot
accurately predict the business decision of an agency based solely on
their status.
Comment: Commenters stated that we should suspend or drop case-mix
adjustments because access would be reduced, particularly among hard-
to-place patients. Commenters predicted that the payment reductions
would have a ``destabilizing effect'' on HHAs and negatively impact
patient access to HH care.
Response: MedPac has previously recommended to the Congress that HH
rates be reduced by 5 percent. (MedPac, Report to Congress: Medicare
Payment
[[Page 70378]]
Policy, March 2009). We believe HH industry margins are sufficient to
support a rate reduction of that size. For example, MedPac projected
2011 margins would remain high, at 13.7 percent (assuming the
previously planned rate reduction of -2.71 percent in 2011). MedPac
also reported that the number of agencies continues to grow, reaching
in excess of 10,400 in 2009. This is a 50 percent increase since 2002,
although growth in new agencies has been highly uneven geographically.
Notably, access to care was sufficient in 2001, when the number of
agencies nationally was much lower than it is today (Office of the
Inspector General, Access to Home Health Care after Hospital Discharge,
July 2001, and Office of the Inspector General, Medicare Home Health
Care Community Beneficiaries, October 2001). Our analysis of cost
reports submitted by the end of 2008 indicates that 99 percent of
beneficiaries are in counties served by at least two agencies, with
more than half of beneficiaries in counties served by at least 11
agencies. Predictions about the number of bankruptcies and effects on
access are highly uncertain. Furthermore, we have no indications that
payment reductions implemented since 2008 have led to access problems
among beneficiaries. During the succeeding period, the total number of
agencies has continued to grow, which is indirect evidence that access
levels have not deteriorated. We intend to request that the Office of
the Inspector General resume investigations of the access impacts of
payment reductions. We will continue to monitor access to care in order
to identify any unintended consequences of our policies in this final
rule. We emphasize that the justification for the nominal case-mix
payment reductions is not HHA margins but rather is the increase in
billed case-mix weights, which our analysis indicates, is unrelated to
changes in underlying patient health characteristics.
Comment: Commenters suggested that we provide funding to HHAs that
admit patients that other agencies avoid.
Response: We have received comments of this nature over the years.
We are unable to definitively characterize such a categorization of
HHAs using administrative data. While we welcome information as to the
characteristics and identity of such agencies, so that we can study
their performance, we would also need to study carefully the
implications of making such distinctions on a permanent basis in our
payment system. We expect many issues would arise. In future rulemaking
we will solicit comment on the various challenges that might arise in
administering payments differently to what some commenters called
``full access organizations'' and potentially other categories of
agencies that might be capable of mitigating access problems, should
they arise.
Comment: Some commenters suggested that CMS focus its efforts on
the study, which will assess possible changes to the HH PPS in order to
ensure access to care.
Response: Section 3131(d) of the Affordable Care Act mandates that
the Secretary conduct a study to evaluate costs related to providing
care to low-income beneficiaries, beneficiaries in medically
underserved areas, and beneficiaries with varying levels of severity of
illness. The section directs the study to be focused on ensuring access
to care for patients with characteristics associated with especially
high costs. We are preparing to launch the mandated study in FY 2011.
Comment: Commenters stated that CMS should suspend or drop nominal
case-mix change reductions because those payment reductions are
contrary to congressional intent in the Affordable Care Act, which
implemented payment reductions on a separate basis. Furthermore,
commenters stated that the 3.79 percent case-mix payment reduction
should count as the ``5 percent cut mandated by the [Affordable Care
Act]'' and the proposed payment decreases should not be implemented in
addition to the Affordable Care Act-mandated payment reductions.
Response: Section 3401(e) of the Affordable Care Act mandated a
market basket reduction and future productivity adjustments. In the
Affordable Care Act, Congress did not make any changes to the pre-
existing provision authorizing CMS to reduce payment rates in response
to nominal case-mix change. Nor did the Congress authorize a
substitution of the case-mix payment reduction for the Affordable Care
Act's five percent payment reduction related to outlier payments
(Section 3131(b) of the Affordable Care Act). Therefore, the reductions
for nominal case-mix changes comply with current law.
Comment: Commenters stated that CMS should suspend or drop case-mix
reductions because CMS should give specific proposals such as therapy
documentation and comorbidity case-mix weight changes time to work.
Response: Our proposals are intended to recoup excess outlays that
have already been made through 2008, outlays that were not justified by
changes in patient severity. Going forward, beginning with 2011, we
would expect to see a moderation of nominal case-mix growth because of
the proposals mentioned by the commenters. Such moderation would
decrease recoupment, if any, proposed in the future.
Comment: A commenter stated that the need for payment reductions in
HH care is ``consistent with the experience of coding changes in other
payment systems.'' However, the methodology ``used to establish the
reduction percentage'' in the inpatient system was flawed and,
therefore, the methodology used to establish the payment reduction for
HH is probably flawed as well.
Response: The payment systems, institutional conditions, data
resources, case-mix assignment procedures, and many other aspects
differ across care settings. Therefore, methodologies must each be
judged on their own individual merits. We have explained and justified
the methodology in this and in previous regulations cited elsewhere in
this preamble.
Comment: We received a comment recommending that we focus the
application of the case-mix change adjustment only to visits beyond the
13th day by changing the OASIS scoring and rate calculation for the
extended cases rather than reducing the base rate and affecting all
visits as a result.
Response: We are unsure of the specific change recommended in this
comment, but we would be concerned that any approach to rate reduction
based on the length of time in treatment within the 60-day episode
would affect fundamental assumptions of the HH PPS system. Most
notably, the system assumes that the amount of resources within the 60-
day period, rather than the timing of their expenditure within that
period, is the appropriate variable use to determine payments in the
case-mix-adjusted payment system.
Comment: One commenter stated that a recent study that used data
from a nationally representative survey (the Medical Expenditures Panel
Survey--MEPS) found a change in real case-mix between 2000 and 2007.
Response: We thank the commenter for the comments. However, we note
that the MEPs analysis appears to be based on all Medicare
beneficiaries, not just the subset of HH patients. Home health users
are less than 10 percent of the fee for service enrolled Medicare
population, so it is not certain that the MEPS study of the entire
Medicare population is relevant to the question of worsening health
status of HH users.
Comment: Commenters stated that CMS should suspend or drop case-mix
reductions because the data used to determine the reductions do not
[[Page 70379]]
recognize real increases in severity due to earlier and sicker hospital
discharges.
Response: While we recognize that average lengths of stay in acute
care are in decline, our analysis shows that agencies are, in fact,
caring for fewer, not more, post-acute patients. Since 2001, the
average length of stay in acute care preceding HH has declined by about
one day, from 7 days to 6 days. However, agencies are caring for fewer
highly acute patients in their caseloads. The proportion of non-LUPA
episodes in which the patient went from acute care directly to HH
within 14 days of acute hospital discharge declined substantially
between 2001 and 2008, from 32 percent to 23 percent. In addition, the
median acute hospital length of stay for these non-LUPA episodes with a
14-day lookback period has remained unchanged at 5 days since 2002 (see
Table 1B, 50th percentile). Since 2005, the distribution has been
stable, except for a 1-day shortening of lengths of stay at the 5th,
80th, and 99th percentiles. We believe the declining prevalence of
recent acute discharges is due in part to more patients incurring
recertifications after admission to HH care, and due to more patients
entering care from the community. The shortening lengths of stay at the
right tail (high percentiles) of the distribution may reflect changing
utilization of long-term-care hospitals during recent years. The
conclusion we draw from these data is that while patients on average
have shorter hospital stays, agencies are also facing a smaller
proportion of HH episodes in which the patient has been acutely ill in
the very recent past. Also, the detailed data on the distribution of
stay lengths suggest that for the most part lengths of stay for such
patients remained stable through 2008, particularly since around 2005.
Table 1B--Percentiles of Acute Hospital Length of Stay (days)
[2001-2008]
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Year 5th 10th 20th 30th 40th 50th 60th 70th 80th 90th 99th
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2001................................................. 2 2 3 4 5 6 7 8 10 14 32
2002................................................. 2 2 3 4 5 5 6 8 10 14 31
2003................................................. 2 2 3 4 4 5 6 8 10 13 30
2004................................................. 2 2 3 4 4 5 6 7 9 13 29
2005................................................. 2 2 3 3 4 5 6 7 9 12 28
2006................................................. 1 2 3 3 4 5 6 7 9 12 28
2007................................................. 1 2 3 3 4 5 6 7 9 12 27
2008................................................. 1 2 3 3 4 5 6 7 8 12 25
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Note: Based on a 10 percent random beneficiary sample of FFS HH users; excludes LUPA episodes and includes only episodes where acute hospital discharge
occurred within 14 days of the from-date of the 60-day episode claim and the patient's first destination post-discharge under Part A was HH care.
Furthermore, we think that acuity of patients has been increasingly
mitigated by lengthening post-acute stays for the substantial number of
HH patients who use residential post-acute care (PAC) prior to an
episode. Our data show that patients who enter residential PAC before
HH admission have experienced increasing lengths of stay in PAC since
2001. Using a 10 percent random beneficiary sample, we computed the
total days of stay (including both acute and PAC days) for HH episodes
with common patterns of pre-admission utilization during the 60 days
preceding the beginning of the episode. We included patients whose last
stay was acute, or whose next-to-last stay was acute with a follow-on
residential PAC stay, or whose third from last stay was acute followed
by two PAC stays. These common patterns accounted for 55 percent of the
initial episodes in 2001 and 42 percent in 2008. We found that total
days of stay during the 60 days leading up to the episode averaged 12.6
days in 2001, and rose to 12.8 days in 2008. This small change in total
days of stay during a period when acute LOS was declining was due to
increasing lengths of stay in residential PAC for these patients. For
example, within the 30 days before admission, average length of stay in
the PAC setting for episodes preceded by an acute stay that was the
next-to-last stay, and where the PAC stay was the very last stay before
the claim-from date, increased from 12.7 to 14.3 days. Our
interpretation of these statistics is that patient acuity has been
increasingly mitigated by longer post-acute stays for the substantial
number of HH patients that use residential PAC prior to the start of a
HH episode. Patient acuity also was mitigated by growing numbers of HH
recertifications.
Comment: A commenter stated the data and analysis we used to
measure real case-mix change do not recognize that technology
improvements in recent years enable patients with more complex
conditions to be cared for at home.
Response: We appreciate this comment but possess limited
information to evaluate it. The data we do have, from OASIS, suggest
that episodes for patients using technological treatments at home are
not increasing. OASIS data show that the proportion of episodes
involving enteral nutrition has declined from 2.9 percent to 1.6
percent between 2001 and 2008; the proportion of episodes involving
intravenous therapy or infusion therapy has stayed stable at around 2.2
percent; and the proportion of episodes involving parenteral nutrition
remains at 0.2 percent or less during that period. The proportion of
episodes with none of those treatments has increased from 94.8 percent
to 96.2 percent. These data are inconsistent with the commenter's
assertion, but we solicit commenters to provide us in the future with
other types of reliable data on this aspect of patient case-mix.
Comment: Many commenters cited improvements in the accuracy of
OASIS coding which could more precisely measure patient severity as a
reason why we should drop its proposal to address nominal case-mix
growth by reducing payments.
Response: Comments referencing coding improvements, such as
increasing accuracy, do not recognize that such improvements are an
inappropriate basis for payment. Measurable changes in patient severity
and patient need are an appropriate basis for changes in payment. Our
analysis continues to find only small changes in patient severity and
need.
Comment: Commenters stated that the increase in case-mix is due to
the HHA's diligence in ensuring proper coding; CMS's implementation of
payment reductions would therefore penalize HHAs for proper coding,
while the agencies who were not ethical or diligent in their coding
would not be affected as much. Furthermore, a commenter suggested that
part of the
[[Page 70380]]
``nominal'' case-mix changes were due to HHAs' past failures to code
properly. The commenter stated that when the HH PPS system was first
implemented in 2000, HHAs undercoded in a manner that generated
insufficient resources to adequately care for the patient. After
modifications were made to the HH PPS system in 2008, coding was still
not adequate for the patient. The commenter stated that, for these
reasons, the baseline average case-mix is much lower than the actual
value.
Response: We agree with the commenter's explanation of previous
undercoding as a cause of nominal case-mix growth. Over the years, we
have issued and revised instructions for OASIS to reinforce the
importance of complete and accurate coding. As we have stated in
previous regulations, however, Medicare should not inappropriately make
greater reimbursements for a patient population whose level of severity
has changed relatively little over the years, notwithstanding more-
comprehensive documentation of the health status of these patients.
Comment: A commenter stated that much of the increase in case-mix
weights is due to HHAs complying with Medicare instructions regarding
patient coding consistent with the 2008 version of the HH PPS.
Response: This comment is difficult to address because the
commenter does not cite specifically which documents constitute CMS-
issued Medicare instructions ``consistent with the 2008 version of the
HH PPS.'' Nor does the comment explain how the increase in case-mix
weights was driven by such CMS instructions. However, we believe our
release in late 2008 of a revision of Attachment D of the OASIS
Instruction Manual would not have had the effect suggested by the
comment. (Attachment D was intended to provide guidance on diagnosis
reporting and coding in the context of the HH PPS.) First, Attachment D
reiterated traditional CMS guidance about how to select diagnoses in
home health. Attachment D did not deviate from the fundamental and
longstanding instruction that reported diagnoses must be relevant to
the treatment plan and the progress or outcome of care. Second,
Attachment D's release late in the year suggests it would not have had
much impact on the 2008 data.
Comment: We received a number of comments stating that HH patients
now have more complex conditions than previous populations of HH
patients and that such patients previously would have been referred to
health care facilities, but are now being cared for at home. Moreover,
the commenters stated that other healthcare settings have developed
stricter admission requirements, thereby increasing the number of HHA
patients with high severity levels. One commenter cited as evidence
diversion of patients to home care from inpatient rehabilitation
facilities due to the CMS 60 percent rule and skilled nursing
facilities' (SNFs') technology increases. The commenters point to such
changes as evidence that policy incentives favor the home setting over
institutional care, and therefore, case-mix increases are warranted.
Response: We appreciate the comment, but we have little information
with which to evaluate the claim regarding diversion to the home care
setting. Possibly relevant is that the proportion of initial non-LUPA
episodes preceded by acute care within the previous 60 days has
declined between 2001 and 2008, from 70.0 percent to 62.7 percent. This
indicates more patients are being admitted from non-institutional
settings, for example, the community. However, our data do not indicate
whether the patients coming into home care without recent care in a
Part A setting were diverted from entering such settings in favor of
home-based care. Post-acute institutional utilization data perhaps
consistent with the comment suggest a decline in inpatient
rehabilitation facilities (IRFs) as a source of HH patients, but this
decline may have been partly offset by an increase in SNF utilization
as a source. For example, the proportion of initial episodes preceded
by an IRF stay that ended sometime during the 30 days before HH
admission suddenly declined by more than a percentage point in 2005 and
declined another 1.5