$05:Civil Money Penalty
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
Hillman Rehabilitation Center,
Petitioner,
- v. -
Health Care Financing Administration.
DATE: May 22, 1996
Docket No. C-95-159
Decision No. CR419
DECISION
In this decision I conclude that the Health Care Financing Administration (HCFA)
did not establish a basis
for terminating Petitionerþs participation in the Medicare program. HCFA
failed to prove by a
preponderance of the evidence that Petitioner was not complying with a condition
of participation in
Medicare.
I. Background
The following background facts and law are not disputed by the parties. Petitioner
is a provider of
outpatient physical therapy and rehabilitation services. Its business office
is in Lakewood, New Jersey.
Petitioner treats a few patients at its Lakewood address. It provides the vast
majority of its treatments to
patients at eight long-term care facilities that are located throughout the
State of New Jersey. Petitioner
rents office space from these facilities. It employs therapists who provide
treatment at the long-term care
facilities. Petitioner maintains its original patient records at the long-term
care facilities and not at its
Lakewood address.
Petitioner's administrator is Dr. Benjamin Akinrolabu. Dr. Akinrolabu holds
both master's and doctorate
degrees in physical therapy.
The Medicare program reimburses a qualified entity for providing outpatient
physical therapy services to
an eligible beneficiary, if that entity is certified by HCFA as a provider of
care, pursuant to the provisions
of section 1861(p) of the Social Security Act (Act) and implementing regulations.
Petitioner was certified
by HCFA in or about 1985 to participate in Medicare as a provider of outpatient
physical therapy services.
The conditions of participation for entities who provide outpatient physical
therapy services are stated in
section 1861(p) of the Act and in 42 C.F.R. 405.1701 - 405.1726. A provider
may participate in
Medicare only if the provider complies with applicable conditions of participation
and other participation
requirements. 42 C.F.R. 489.13. HCFA may terminate a providerþs participation
in Medicare for failing
to comply with an applicable condition of participation. See 42 C.F.R. 488.24(a).
1/
HCFA directs that a periodic compliance survey be conducted of a participating
provider to assure that the
provider is complying with applicable participation requirements. HCFA contracts
with agencies of State
governments (State Agencies) to perform compliance surveys. Act, section 1864(a);
42 C.F.R. 488.10 -
488.12, 488.20 - 488.24. HCFA makes compliance determinations based on recommendations
made by
State Agency surveyors. Id. In New Jersey, the State Agency is the New Jersey
Department of Health.
Petitioner was visited by a surveyor employed by the New Jersey State Agency
on January 13, 1995,
February 22, 1995, and April 5, 1995. On the occasion of each visit, the surveyor,
Charles End, R.N.,
visited Petitionerþs Lakewood, New Jersey business office. 2/ On none
of these occasions did Mr. End or
any other representative of the New Jersey State Agency visit Petitioner at
any of the eight long-term care
facilities at which Petitioner provides outpatient physical therapy and rehabilitation
services.
Using the surveyorþs findings from the January 13, 1995 survey, HCFA determined
that Petitioner was not
complying with several conditions of participation. At the February 22, 1995
survey, Petitioner was found
to be complying with all conditions of participation. However, after the April
5, 1995 visit by the
surveyor, HCFA determined that Petitioner was not complying with two conditions
of participation. These
conditions of participation are stated in 42 C.F.R. 405.1717 (plan of care and
physician involvement) and
in 42 C.F.R. 405.1722 (clinical records). HCFA terminated Petitionerþs
participation in Medicare,
effective July 5, 1995.
Petitioner requested a hearing. I held a hearing in Trenton, New Jersey, on
February 13, 1996. I base my
decision on the record of the hearing and on the applicable law.
II. Issues, findings of fact and conclusions of law
The issue in this case is whether HCFA proved that, on April 5, 1995, Petitioner
was not complying with a
condition of participation in Medicare. If I were to find that HCFA proved that
Petitioner was not
complying with a condition of participation, then I would sustain HCFAþs
determination to terminate
Petitionerþs participation in Medicare.
HCFA asserts that, as of April 5, 1995, Petitioner was not complying with two
conditions of participation.
These are the condition governing plans of care and physician involvement in
the planning and delivery of
care contained in 42 C.F.R.
405.1717 and the condition governing clinical records contained in 42 C.F.R.
405.1722.
In concluding that HCFA did not establish grounds for terminating Petitionerþs
participation in Medicare, I
make the following findings of fact and conclusions of law (Findings). I discuss
each of these findings in
detail, below.
1. HCFA has the burden of proving that Petitioner failed to comply with a
condition of
participation in Medicare.
2. The Act and regulations require Petitioner to maintain clinical records
that are completely and
accurately documented, readily accessible, and systematically organized to facilitate
retrieving and
compiling information.
3. Petitioner is not obligated to maintain at its Lakewood, New Jersey, business
office complete
and contemporaneous copies of records of treatments that it provides at eight
long-term care centers.
4. The account by the New Jersey State Agency surveyor of his April 5, 1995
visit to Petitioner is
not credible.
5. HCFA did not prove that Petitioner failed to comply with the condition
of participation
governing plans of care and physician involvement in the planning and delivery
of care contained in 42
C.F.R. 405.1717.
6. HCFA did not prove that Petitioner failed to comply with the condition
of participation
governing clinical records contained in 42 C.F.R. 405.1722.
III. Discussion
A. HCFAþs burden of persuasion (Finding 1)
1. Allocation of the burden of persuasion to HCFA
I conclude here, as I have in other cases involving termination of a providerþs
participation in Medicare,
that HCFA has the burden of proving that there is a basis for terminating Petitionerþs
participation in
Medicare. Nazareno Medical Hospice Fajardo, Caguas, Cayey, DAB CR386, at 6 -
19 (1995); Hospicio en
el Hogar de Utuado, DAB CR371, at 6 - 10 (1995); Hospicio en el Hogar de Lajas,
DAB CR366, at 6 - 8
(1995); Arecibo Medical Hospice Care, DAB CR363, at 8 - 13 (1995). Neither the
Act nor regulations
state who has the burden of persuasion in a case involving termination of a
providerþs certification to
participate in Medicare. The regulations which govern a hearing in such a case
give the administrative law
judge discretion to allocate the burden of persuasion as is appropriate. 42
C.F.R.
498.60(b)(1) and (3). It is both consistent with due process requirements and
efficient to assign the
burden to HCFA.
HCFA has obtained the evidence that it believes justifies its determination
to terminate Petitionerþs
participation. Therefore, it is entirely reasonable to put HCFA to the test
of proving that its determination
is supported by the preponderance of the evidence.
In a case involving termination, it is generally not reasonable to require
the provider to prove a negative
proposition -- that it did not fail to comply with a condition of participation
-- in the absence of proof that it
failed to comply with that condition of participation. As I found in Nazareno,
to require a provider to
prove the negative proposition in the absence of affirmative proof from HCFA
would invite a massive and
unfocused presentation of evidence by the provider. Nazareno, at 8. In the absence
of a prima facie case
that the provider had failed to comply with a condition of participation, the
provider might have to guess at
the evidence necessary to prove that it had not failed to comply with the condition.
HCFA avers that it is willing to assume the burden of first coming forward
with evidence of Petitionerþs
failure to comply with a condition of participation, thus giving Petitioner
notice of what it needs to rebut.
HCFA made the same offer in Nazareno. I did not understand the logic of that
offer there, nor do I
understand it here.
If HCFA has a burden of coming forward with evidence, but no burden of persuasion,
then HCFA has
neither an obligation nor an incentive to make even a prima facie case to justify
its determination to
terminate Petitionerþs participation. Indeed, under HCFAþs theory,
Petitioner could offer evidence which
might rebut completely whatever evidence HCFA opts to offer, but which would
fail to overcome the
presumption of validity which HCFA asserts attaches to its determination to
terminate Petitioner's
participation in Medicare.
My conclusion that the burden of persuasion should be assigned to HCFA in this
case does not mean that it
should be assigned to HCFA in every case. I will continue to evaluate the issue
of burden of persuasion on
a case-by-case basis, although, generally, and for the reasons I have stated
above, I would be likely to
assign it to HCFA in a case where HCFA terminates a provider's participation
in Medicare.
In Nazareno, I noted that there may be circumstances where identical considerations
of due process and
efficiency as apply here support allocation of the burden of persuasion to the
provider, and not to HCFA.
A good example of such a case is the case where a provider challenges HCFAþs
determination of the
effective date of that providerþs participation in Medicare. In that case,
the provider, and not HCFA, is
most likely to be in possession of evidence proving that it qualified to participate
in Medicare at an earlier
date than the date determined by HCFA. Nazareno, at 7 n.5; SRA, Inc., D/B/A
St. Mary Parish Dialysis
Center, DAB CR341, at 5 (1994).
In arguing that the burden of persuasion must be allocated to Petitioner, HCFA
makes the same arguments
here that it made in Nazareno, Utuado, Lajas, and Arecibo. In those decisions,
I addressed these arguments
at length. It is unnecessary for me to address them again here, in great detail.
I summarize HCFAþs
arguments, along with my reasons for finding them to be without merit.
HCFA does not deny that I have discretion to allocate the burden of persuasion
to a party, nor does HCFA
assert that it is unreasonable for me to allocate the burden of persuasion to
HCFA. Instead, HCFA asserts
that, under various principles of administrative law, the burden of persuasion
must be allocated to
Petitioner.
First, HCFA asserts that Petitioner is a mere þapplicantþ for benefits
with no right to due process. HCFA
posthearing memorandum at 21. HCFA argues that, traditionally, an applicant
has the burden of proving
that it is eligible for the benefits that it seeks.
A participating provider is not merely an þapplicantþ for benefits.
It is the recipient of a privilege. The
law does not mandate that the burden of persuasion be imposed at all times on
the recipient of a
government benefit or privilege where the government seeks to terminate the
benefit or privilege. In cases
involving termination of Social Security benefits, and in exclusion cases brought
under section 1128 of the
Act, the burden of persuasion on ultimate issues has been allocated to the government,
and not to the
beneficiaries or recipients of privileges whose benefits or privileges the government
seeks to terminate.
Second, HCFA argues that its termination of Petitionerþs participation
is a final agency action which must
be presumed to be valid, even if challenged by a request for a hearing. HCFA
misapplies the presumption
of validity which attaches to a final government agency action that is challenged
in a court of law.
Nazareno, at 12. 3/ There is no presumption of validity which necessarily attaches
to determinations that
are challenged in administrative hearings.
Under a number of regulations which govern determinations made by agencies
of the United States
Department of Health and Human Services, an agency determination becomes final
unless a hearing is
requested. Even so, the burden of persuasion often is assigned to the agency
whose determination is
challenged. For example, a determination by the Social Security Administration
to terminate a
beneficiaryþs Social Security disability benefits becomes final unless
the beneficiary requests a hearing.
However, if the beneficiary requests a hearing, then the burden is on the Social
Security Administration to
prove that the beneficiaryþs medical condition has improved.
In the case of an exclusion determination made by the Inspector General (I.G.)
pursuant to section 1128 of
the Act, the determination becomes final unless a hearing is requested. However,
if a hearing is requested,
the I.G. is assigned the burdens of proving that she has the authority to impose
an exclusion and that the
exclusion is reasonable. See 42 C.F.R. 1005.15(c). Similarly, the burden of
persuasion is assigned to the
I.G. where a request for a hearing is made from a determination made by the
I.G. pursuant to the Civil
Money Penalty Act, section 1128A of the Act. 42 C.F.R. 1005.15(b). That same
assignment of burden
occurs where a hearing is requested from an I.G. determination to exclude pursuant
to section 1156 of the
Act. Id.
2. The elements of HCFAþs burden of persuasion
In Nazareno, I identified the three elements of HCFAþs burden of persuasion
in a case involving
termination of a providerþs participation in Medicare. Nazareno, at 14
- 17. I restate them here, briefly.
First, HCFA must identify the legal criteria to which it seeks to hold the
provider accountable. Nazareno,
at 14 - 15. In doing so, HCFA must identify the specific language in the Act
or regulations on which it is
relying. HCFA must prove that its interpretation of the Act or a regulation
is reasonable, where HCFA
advocates an interpretation that is not apparent from the plain meaning of the
Act or regulation. However,
HCFA is entitled to deference if its interpretation of the Act or a regulation
is one of more than one
reasonable alternative interpretations. Where HCFA relies on an interpretation,
albeit reasonable, that is
not apparent from the plain meaning of the Act or of a regulation, it
must prove that it gave the provider notice of its interpretation before holding
the provider accountable to
it.
Second, HCFA must prove by a simple preponderance of the evidence that its
assertions of fact are true.
Nazareno, at 15. The evidence which HCFA might rely on to establish those facts
may consist of the
testimony of a surveyor or surveyors, or of exhibits.
Third, where HCFA alleges a failure by a provider to comply with a condition
of participation as a basis
for termination of that providerþs participation in Medicare, HCFA must
prove, by a preponderance of the
evidence, that the providerþs failure to comply with participation requirements
meets the definition of a
condition-level deficiency stated in 42 C.F.R. 488.24(a). In order to be a condition-level
deficiency, a
failure to comply with participation requirements must be:
of such character as to substantially limit the providerþs . . . capacity
to render adequate care or which
adversely affect[s] the health and safety of patients; . . . .
Id.
In establishing the degree of a deficiency, HCFA may rely on the qualified
testimony of a surveyor.
However, the surveyorþs testimony will not be presumed to be true or authoritative.
The testimony of the
surveyor will be accorded the weight that it ought to receive, based on the
experience and background of
the surveyor, and the credibility of the surveyorþs testimony.
B. Petitionerþs obligation to maintain records of the physical therapy
it provides to patients
(Findings 2-3)
HCFA premises its case against Petitioner on HCFAþs assessment of the
excerpts from patient treatment
records that the New Jersey State Agency surveyor reviewed at Petitionerþs
Lakewood, New Jersey office
on April 5, 1995. HCFA Ex. 12, 17 - 35; Tr. at 72 - 74. HCFAþs allegations
that Petitioner was not
complying with conditions of participation result from the surveyorþs
and HCFAþs conclusions that these
records were incomplete or inadequate. HCFA Ex. 12. The surveyor never visited
the eight facilities at
which Petitioner provided outpatient physical therapy and rehabilitation services
and made no effort to
ascertain whether the patient records that Petitioner maintained at these facilities
were incomplete or
inadequate. Tr. at 122 - 124.
At the hearing, Petitioner produced records which it asserts to be complete
copies of the original records
that were maintained at the long-term care facilities. P. Ex. 9 - 28. Petitioner
asserts that these exhibits
rebut fully any inference that might be drawn from the records obtained by HCFA
on April 5, 1995 that
Petitioner was not complying with Medicare conditions of participation. The
parties agree that these
exhibits are not records that Petitioner had at its Lakewood office on April
5, 1995. HCFA argues that
these records are irrelevant, because they were not present at Lakewood on April
5, 1995, nor were they
provided to HCFAþs surveyor on that date.
HCFA asserts that Petitioner had a duty to maintain complete and contemporaneous
copies of patient
treatment records at its Lakewood office. HCFA argues that Petitioner could
not comply with Medicare
participation requirements by maintaining such records only at the facilities
at which Petitioner provided
treatment to patients. HCFA asserts that because Petitioner was obligated to
maintain contemporaneous
copies of patient records at Lakewood, HCFA could draw dispositive inferences
and conclusions about
Petitionerþs compliance with participation requirements from the records
that the surveyor reviewed at the
Lakewood office.
However, even as HCFA argues that it is essential that Petitioner maintain
complete and contemporaneous
copies of its treatment records at its headquarters, HCFA maintains that it
is not really holding Petitioner to
the asserted requirement in this case. HCFA states that the þentire question
of whether . . . [Petitioner] was
required to maintain copies of the clinical records at its certified location
is just smoke and mirrors.þ
HCFA posthearing memorandum at 16. According to HCFA, it did not terminate Petitionerþs
participation
because Petitioner failed to keep copies of its records at the Lakewood office.
HCFA argues that it
terminated Petitionerþs participation only because the records that Petitioner
produced on April 5 at its
Lakewood office proved that Petitioner was not complying with conditions of
participation.
Contrary to HCFA's argument, HCFAþs contentions about Petitionerþs
record-keeping obligations are
central to HCFAþs case against Petitioner. HCFA relies on its argument
that Petitioner was required to
maintain complete contemporaneous copies of its treatment records at its Lakewood
office as a basis to
assert that I should not find the treatment records that Petitioner introduced
into evidence at the hearing to
be relevant. HCFA posthearing memorandum at 24 - 25; see P. Ex. 9 - 28. Furthermore,
HCFA argues
that an aspect of Petitionerþs alleged failure to comply with the record-keeping
requirements of 42 C.F.R.
405.1722 is Petitionerþs failure to maintain complete contemporaneous
copies of all of its treatment
records at its Lakewood office. HCFA posthearing memorandum at 25 - 29, 45 -
46, 53.
The Act and regulations require Petitioner to maintain complete records of
the treatments it provides to
patients. These records must be systematically organized and easily accessible.
Petitioner is obliged to
produce those records for HCFAþs review and inspection, on reasonable
notice by HCFA. However, there
is no requirement in the Act or in the regulations that Petitioner retain either
original treatment records or
contemporaneous copies of those records at its business office. HCFA's argument
that Petitioner is
precluded from offering records obtained from the long-term care facilities
as evidence that it complied
with Medicare participation requirements, simply because those records were
not present at Lakewood
during the April 5, 1995 visit by the surveyor, is not persuasive.
The Act does not contain any requirement that would direct an outpatient physical
therapy and
rehabilitation provider which offers its services at more than one site, such
as Petitioner, to centralize
complete contemporaneous copies of all of its patient treatment records. It
requires only that the provider
maintain clinical records on all of its patients. Act, section 1861(p)(4)(A)(iii).
Nor do the regulations contain language which directs an outpatient physical
therapy and rehabilitation
provider to centralize its records at one address. There is no requirement in
42 C.F.R. 405.1722 that
directs an outpatient physical therapy and rehabilitation provider that furnishes
care at multiple sites to
maintain its original treatment records, or contemporaneous copies of those
records, at a central repository.
The regulation requires explicitly that records be: complete, accurate, systematically
organized,
conveniently located, and readily retrievable. The regulation leaves it to the
provider to design a record-
keeping system that satisfies these requirements. The regulation thus permits
a provider, such as Petitioner,
to maintain its treatment records at the sites where treatment is furnished,
so long as the provider is able to
access the records, and to retrieve information in those records, or copies
of them, promptly when
necessary.
My conclusion as to the meaning of the Act and regulations means that records
produced by Petitioner of
the treatments it provided to patients which were not available to the surveyor
on April 5, 1995, are
relevant in deciding whether HCFA proved that Petitioner was in fact, deficient
in complying with those
conditions of participation that HCFA cited in its determination to terminate
Petitionerþs participation in
Medicare. See P. Ex. 9 - 28. However, my conclusion that neither the Act nor
regulations require
Petitioner to retain contemporaneous copies of its treatment records at its
Lakewood office is not a finding
that Petitioner maintained its records pursuant to the requirements of the Act
or regulations. HCFA did not
determine, as a basis for terminating Petitionerþs participation in Medicare,
that Petitioner failed to
maintain a system of records required by the Act or regulations. Therefore,
it is not necessary for me to
make a finding that Petitioner either maintained or did not maintain such a
system.
HCFA acknowledges that the asserted requirement that an outpatient physical
therapy and rehabilitation
provider centralize contemporaneous copies of all records is not stated in either
the Act or in regulations.
HCFAþs post-hearing memorandum at 25. But, according to HCFA, the asserted
requirement is þthe only
reasonable interpretation possibleþ of the Act and regulations. Id. HCFA
claims that to be so for several
reasons. Id. at 25 - 29. I am not persuaded by HCFAþs arguments that the
Act or regulations may be
interpreted reasonably to require Petitioner to maintain contemporaneous copies
of its treatment records at
a centralized location. These arguments do not overcome the fact that the Act
and regulations do not
contain the requirement asserted by HCFA. I find also that, individually, and
collectively, HCFAþs
arguments are not persuasive.
First, HCFA argues that the regulations state requirements that must be met
by providers and not by the
therapists who are employed by providers. Therefore, according to HCFA, it makes
sense to read the
record-keeping requirements of the regulations as mandating Petitioner to maintain
a centralized records
system. I agree with HCFA that the regulations impose requirements on the provider
of care and not on the
therapists who are employed by the provider. But that begs the question of whether
the regulations tell the
provider that it must maintain a central records system of contemporaneous copies
of all treatment records.
Second, HCFA cites language in the regulations which requires a provider to
perform specific tasks,
including performing research and administrative actions. See 42 C.F.R. 405.1722(e).
HCFA argues that
a provider, such as Petitioner, that furnishes care at more than one site must
centralize its records in order
to perform these research and administrative actions. I do not agree that this
contention is, in fact, correct.
HCFA has not persuaded me that a provider must centralize its records in order
to perform the tasks
mandated by the regulations. Nor do the regulations cited by HCFA contain any
requirement that the
records be centralized. The regulations provide only that the records be readily
accessible and
systematically organized. HCFA has not shown, nor do I otherwise have in this
case any basis to find, that
a provider could not perform the tasks mandated by the regulations so long as
it maintains records
accurately and systematically, in adequate facilities that are conveniently
located, and is able to retrieve
information from those records promptly.
Third, HCFA argues that the regulations require that all records must be readily
accessible to a surveyor.
According to HCFA, it is not acceptable for Petitioner to have treatment records
only at the location where
the patient is receiving physical therapy. Instead, HCFA maintains that Petitioner
must have all records
necessary for HCFA's review located at its headquarters location. HCFA asserts
that the New Jersey State
Agency surveyor had no obligation to visit any of the facilities at which Petitioner
provided care in order to
survey Petitioner's compliance with participation requirements. HCFA argues
that, because Petitioner
provides services in disparate locations, the only way in which Petitioner could
have complied with the
asserted requirement that it make records readily accessible to the surveyor
was to have centralized
contemporaneous copies of all records available to surveyors at Petitioner's
central office location.
I agree with HCFA that there is an implied requirement in the regulations that
a provider maintain records
in a way that enables a surveyor to have access to them. However, HCFA did not
prove that the
requirement that a provider maintain its records in a way that enables a surveyor
to have access to them
means that a provider must maintain its records, or contemporaneous copies of
those records, in a central
location. 4/
HCFA is not obligated to conduct surveys at multiple caregiving sites, where
a provider has decentralized
operations. 5/ It would not be inappropriate for the New Jersey State Agency
surveyor to visit Petitionerþs
business office in Lakewood, New Jersey, and to request that Petitioner produce
its records at that location,
for review by the surveyor. However, that does not mean that a provider must
maintain complete,
contemporaneous copies of its records in one location to facilitate a survey.
The regulation requires only
that the provider be able to produce its records if a surveyor requests to see
them. Conceivably, a provider
could fax or express mail copies of its records to a single site, if a surveyor
requests to review them at that
site. 6/
Fourth, HCFA argues that Petitioner was certified to be a provider only at
its Lakewood, New Jersey
business address. Therefore, according to HCFA, the only location at which Petitioner
was certified to
maintain treatment records was at the Lakewood address. I do not agree with
this assertion. I do not read
the regulations as requiring a provider to maintain its patient treatment records,
or contemporaneous copies
of its records, at the office at which it is certified. There is simply no such
requirement in the regulations.
Fifth, according to HCFA, accepted professional standards and practices are
that providers centralize their
records. HCFA bases this argument on the testimony of Mr. End, that seems to
indicate that he had
performed hundreds of surveys and had never encountered a health care facility
that did not maintain
copies of its records at its main office. Tr. at 56.
I do not find that HCFA proved through the anecdotal testimony of Mr. End that
professionally accepted
standards of practice require an outpatient physical therapy and rehabilitation
provider that furnishes care
at multiple sites to maintain its treatment records, or contemporaneous copies
of its records, centrally. Mr.
End is not a physical therapist or a specialist in rehabilitation. He did not
testify as to accepted standards of
practice which apply to an outpatient physical therapy and rehabilitation provider.
Mr. End did not testify
explicitly that providers who furnished care at multiple sites adhered to a
practice of maintaining records
centrally. It is logical that a hospital or a laboratory or other provider housed
under a single roof maintain
its treatment records at that location. But, I am not convinced from Mr. Endþs
testimony that what might
be standard practice for such entities necessarily is followed by entities that
are decentralized.
HCFA argues that Petitioner agreed to maintain contemporaneous copies of its
treatment records at
Lakewood. HCFA reply brief at 7. I am not persuaded by the evidence offered
by HCFA that Petitioner
made this asserted promise. HCFA bases its assertion in part on the contents
of a plan of correction which
Petitioner executed which allegedly contains the asserted promise. Tr. at 61
- 63. However, HCFA did not
introduce the plan of correction into evidence. Tr. at 62. Instead, it asked
Mr. End to paraphrase the plan
in his testimony. Tr. at 61 - 63. As I advised the parties at the hearing, having
a witness paraphrase a
document which could have been introduced into evidence is not an acceptable
substitute for introducing
the document itself. Tr. at 64 - 66. I do not find Mr. Endþs paraphrasing
of the plan of correction to be a
credible statement of what the plan contains.
The credible evidence does not establish that Petitioner promised to maintain
at its Lakewood office
contemporaneous copies of its treatment records. To the contrary, it proves
at most that Petitioner
promised that it would maintain such records at its Lakewood office, updated
at 30-day intervals. HCFA
Ex. 10; P. Ex. 2. 7/
Finally, if HCFA thought it important that Petitioner maintain contemporaneous
copies of its treatment
records at Lakewood, it did not make that asserted requirement plain to Petitioner.
Mr. End testified that,
although Petitioner was not complying with the asserted record-keeping requirement
as of a February 22,
1995 survey, he concluded that Petitioner was complying with all conditions
of participation. Tr. at 68 -
69. 8/ Furthermore, Petitioner expressly advised HCFA of its intent to update
treatment records at
Lakewood at 30-day intervals. HCFA Ex. 10; P. Ex. 2. There is no evidence that
either the State agency
or HCFA expressed any dissatisfaction to Petitioner about this proposed record-keeping
system.
C. The credibility of HCFAþs account of the April 5, 1995 survey of Petitioner (Finding 4)
In evidence are two different versions of the same patient records and two
conflicting versions of how
these records came to be made. HCFA asserts that the patient records it introduced
as HCFA Ex. 17 - 35
comprise the documentation of Petitionerþs patient treatments and record-keeping
that Petitioner presented
to HCFAþs surveyor on April 5, 1995, in response to a request for a production
of records made by the
surveyor on that date. Petitioner avers that HCFA Ex. 17 - 35 consist only of
excerpts of patient records
from Petitionerþs claims files that it provided on April 5, 1995 in response
to a claims inquiry. It alleges
that HCFAþs surveyor did not ask Petitioner to produce treatment records
on April 5, 1995. Petitioner
asserts that P. Ex. 9 - 28, which are a different version of the records contained
in HCFA Ex. 17 - 35,
comprise Petitionerþs actual patient treatment records. 9/ Petitioner
asserts that it did not present the
records contained in P. Ex. 9 - 28 to the surveyor on April 5, 1995, because
the surveyor did not ask for
them.
The differences between HCFA Ex. 17 - 35 and P. Ex. 9 - 28 lie mainly in the
completeness of the records.
For example, HCFA Ex. 17 - 35 all contain plans of care for physical therapy
for individual patients.
These plans, by and large, are signed by the physical therapist who created
them, but not by the physician
who supervised the providing of care. By contrast, the same plans of care in
P. Ex. 9 - 28 are signed by
physical therapists, and also by physicians. HCFA Ex. 17 - 35 mostly lack physiciansþ
orders for physical
therapy, whereas P. Ex. 9 - 28 mostly contain those orders.
As I conclude at Part III.B. of this decision, Petitioner is not precluded
from introducing patient treatment
records from the eight long-term care facilities at which it furnished care
to rebut HCFAþs assertion that it
was not complying with Medicare participation requirements. That conclusion
does not resolve the
question of the evidentiary weight that I should give to the records introduced
by Petitioner.
HCFA asserts that the records contained in P. Ex. 9 - 28, to the extent that
they contain documents or
signatures not contained in HCFA Ex. 17 - 35, were fabricated by Petitioner
after the April 5, 1995
surveyorþs visit to Petitionerþs Lakewood, New Jersey office, in
order to make it look as if Petitioner was
complying with participation requirements. HCFA argues that the only credible
evidence of the state of
Petitionerþs records as of April 5, 1995 is in HCFA Ex. 17 - 35.
I would regard the records introduced by Petitioner as self-serving exhibits
to which I would attach little or
no probative value if I were to conclude that HCFAþs version of what Petitioner
produced on April 5, 1995
is credible. On the other hand, the exhibits introduced by Petitioner become
potentially very significant to
my evaluation of Petitionerþs compliance with conditions of participation
if I decide that Petitionerþs
version of what happened on April 5, 1995 is credible. Then, the exhibits must
be regarded as the best
evidence of the extent to which Petitioner complied with Medicare conditions
of participation on that date.
Petitionerþs account of the events that occurred on April 5, 1995 is
the more credible account of those
events. The most reliable evidence of the care provided by Petitioner and the
way in which it kept
treatment records as of April 5, 1995 consists of the medical records which
are in evidence as P. Ex. 9 - 28.
Therefore, I base my conclusions as to HCFAþs allegations that Petitioner
was not complying with
conditions of participation on P. Ex 9 - 28, and not on the excerpts of medical
records which HCFA
introduced as HCFA Ex. 17 - 35.
HCFA asserts that, on April 5, 1995, Mr. End demanded Petitioner provide him
with the complete records
of 20 specified patients. According to HCFA, Petitioner represented to Mr. End
that the documents that it
furnished to him on that date comprised Petitionerþs complete treatment
records of the 20 patients. See
HCFA Ex. 17 - 35.
Mr. End testified that, on April 5, 1995, he visited Petitionerþs Lakewood
office in the company of another
individual, Jerry Livesay, a representative of Aetna Insurance Company, the
Medicare intermediary. Tr. at
71. 10/
According to Mr. End, Mr. Livesay was performing an inquiry into some billing
problems that the
intermediary had with Petitioner. Id. Mr. End testified that Mr. Livesay brought
with him a list of 20
patients about whom there were billing problems. Id. at 72. Mr. End asserted
that he relied on this list to
ask for Petitionerþs treatment records. Id.
Mr. End testified that he met with Dr. Akinrolabu, and asked Dr. Akinrolabu
to produce the treatment
records for the 20 patients. Tr. at 72. Mr. End testified that he requested
to be present when the records
were taken from Petitionerþs files. Id. According to Mr. End, he and Dr.
Akinrolabu went to Petitionerþs
files, to discover that the records were not present there. Id. Mr. End asserted
that the records which are in
evidence as HCFA Ex. 17 - 35 were faxed into Petitionerþs Lakewood office,
piecemeal, over a period of
two or three hours.
Dr. Akinrolabu testified that, on April 5, 1995, Mr. Livesay and Mr. End visited
Petitionerþs Lakewood
office. Tr. at 211. According to Dr. Akinrolabu, all of the discussion that
occurred on April 5, 1995 was
between himself and Mr. Livesay. Id. at 212. Dr. Akinrolabu testified that Mr.
Livesay informed him that
he and Mr. End were doing a claims integrity check. Tr. at 212 - 213. Dr. Akinrolabu
testified that Mr.
Livesay informed him that he wanted to see specific claims-related documents
which pertained to the
patients on the list of patients that Mr. Livesay had brought to Petitionerþs
Lakewood office. Id. at 213.
Dr. Akinrolabu asserted that he complied with Mr. Livesayþs request by
having an employee obtain
documents that Petitioner maintained for claims purposes. Id. Dr. Akinrolabu
denied that he was asked by
either Mr. Livesay or Mr. End to obtain documents from the long-term care facilities
at which Petitioner
provided treatments. Id. at 214. He denied that documents were faxed to the
Lakewood office on April 5,
1995 to be provided to Mr. Livesay or to Mr. End. Id. at 213, 216 - 217.
Dr. Akinrolabu explained the differences between HCFA Ex. 17 - 35 and P. Ex.
9 - 28 by asserting that
Petitioner would obtain partially executed treatment records from the long-term
care facilities in order to
create a record for claims purposes. Frequently, those records had not been
completed when they were
submitted, because Petitioner viewed it as unnecessary to have them fully executed
in order to memorialize
for claims purposes the services that Petitionersþ employees provided.
Tr. at 228 - 232.
On its face, the testimony of Mr. End and that of Dr. Akinrolabu is credible.
I do not find from the
demeanor of either witness that the witness was not credible. Yet, obviously,
the testimony of the two
witnesses is directly contradictory on major points. There is no witness who
corroborates the testimony of
either Mr. End or Dr. Akinrolabu. Thus, I cannot make credibility conclusions
concerning these
witnessesþ conflicting testimony from corroborating testimony or impeachment
testimony by a third party
witness. I must evaluate the relative credibility of the witnessesþ testimony
by measuring that testimony
against whatever facts are in evidence that supports it or contradicts it.
Dr. Akinrolabuþs version of what happened on April 5, 1995 is the more
credible version. I base my
conclusion on the following: (1) the primary purpose of the April 5, 1995 visit
to Petitionerþs Lakewood
office was not to conduct a Medicare compliance survey, but to review Petitionerþs
billing records to
satisfy questions raised by the Medicare intermediary, and Petitionerþs
assertion that it produced only
billing records on that date is consistent with that purpose; (2) Mr. Endþs
testimony that Petitioner faxed
documents to its Lakewood office on April 5, 1995 is not credible; and (3) on
their face, the records which
Petitioner introduced at the hearing are consistent with what Petitioner purports
them to be, which is
complete treatment records of the 20 patients whose records are at issue here.
Mr. End and Dr. Akinrolabu agree on one point, that being that the primary
purpose of the April 5, 1995
visit to Petitionerþs Lakewood office was for the intermediaryþs
representative, Mr. Livesay, to conduct an
inquiry related to Petitionerþs claims. It was Mr. Livesay who brought
the list of patients whose records
were to be reviewed. I am persuaded that the most likely records to be sought
on that date would have
been records related to Petitionerþs reimbursement claims. This substantiates
Dr. Akinrolabuþs assertion
that the documents which were requested on April 5 were claims documents. It
also provides some support
for Dr. Akinrolabuþs assertion that his interactions on that date were
with Mr. Livesay, and not Mr. End.
Mr. Endþs assertion that, on April 5, 1995, Petitioner had records faxed
to its Lakewood office from the
long-term care facilities is not supported by any credible evidence, and is
in key respects, contradicted by
the evidence of record. Mr. End admitted that he did not personally witness
any document being faxed to
Petitionerþs Lakewood office. Tr. at 119 - 120. More telling, none of
the documents that comprise HCFA
Ex. 17 - 35 have the appearance of documents that were faxed to Petitioner.
Dr. Akinrolabu testified,
without contradiction, that Petitionerþs fax machine at Lakewood would
have left an imprint on each
document that was faxed to that machine. Tr. at 217. None of the pages of HCFA
Ex. 17 - 35 contain fax
imprints.
The exhibits which comprise P. Ex. 9 - 28 have the appearance of patient records.
They contain plans of
care, physiciansþ order forms, and records of treatment. They are signed
by the individuals who provided
care to the patients, including physicians and physical therapists. There are
numerous individuals whose
signatures appear on the exhibits. The exhibits have every appearance of being
what they are offered as --
genuine treatment records of patients -- and not of self-serving or fabricated
documents.
D. HCFAþs allegation that Petitioner did not comply with the condition
of participation
governing plans of care contained in 42 C.F.R. 405.1717 (Finding 5)
I have evaluated HCFAþs allegation that Petitioner did not comply with
the condition of participation
governing plans of care contained in 42 C.F.R. 405.1717 by measuring the credible
evidence and the
arguments offered by HCFA against the three elements of HCFAþs burden
of persuasion which I outlined
at part III.A.2. of this decision. I conclude that HCFA failed in several respects
to prove that Petitioner did
not comply with the condition of participation stated in the regulation. First,
HCFAþs asserted
interpretation of the regulation is not consistent with the language of either
the regulation or of the Act, and
is not reasonable. Second, even if I accept HCFAþs interpretation of the
regulation, and use that
interpretation as a basis for evaluating Petitionerþs compliance, the
weight of the evidence fails to
substantiate HCFAþs assertion that Petitioner did not comply with the
requirements of the regulation.
Third, HCFA has not proven that Petitionerþs asserted failure to comply
with the regulation is a condition
level deficiency.
1. The requirements of the plan of care regulation
HCFA would read the plan of care regulation to require the physician to approve
the details of physical
therapy before therapy is initiated by the physical therapist. I find this asserted
interpretation is
inconsistent with the requirements of section 1861(p) of the Act and exceeds
the plain meaning of the plan
of care regulation. Although a physician must order physical therapy as a prerequisite
to initiation of
therapy, both the Act and the plan of care regulation plainly permit a physical
therapist to prepare a plan of
care and to initiate the therapy pursuant to a physicianþs order without
first having the details of that
therapy approved by a physician. Administration of physical therapy must be
reviewed by a physician no
less than 30 days from initiation of therapy.
Section 1861(p)(2) of the Act permits either a physician or a physical therapist
to establish the care that is
provided to a patient. It requires that the therapy be periodically reviewed
by a physician. The Act
provides for coverage for physical therapy for a Medicare beneficiary:
with respect to whom a plan prescribing the type, amount and duration of physical
therapy services that
are to be furnished . . . has been established by a physician . . . or by a
qualified physical therapist and is
periodically reviewed by a physician. . . .
Act, section 1861(p)(2) (emphasis added).
Although there is no explicit requirement in section 1861(p) of the Act or
regulation that physical therapy
not be administered unless first ordered by a physician, the conditions of coverage
under Part B of the
Medicare program would not permit reimbursement for physical therapy that is
not certified as necessary
by a physician. Act, section 1814(a)(2). When section 1814(a)(2) is read together
with section 1861(p), it
is apparent that the Act mandates that physical therapy be ordered by a physician,
although the physician
does not have to participate in the planning of the details of the therapy and
in the initial administration of
the therapy. 11/
The plan of care regulation, 42 C.F.R. 405.1717, is consistent with section
1861(p) of the Act. It permits
either a physician or a physical therapist to prepare a plan of care and to
initiate care. It requires that a
physician review the administration of care, at least once every 30 days. The
regulation states the
following general condition of participation:
For each patient in need of outpatient physical therapy or speech pathology
services there is a written
plan of care established and periodically reviewed by a physician, or by a physical
therapist or speech
pathologist, respectively. . . .
42 C.F.R. 405.1717. A standard contained in the regulation provides, in relevant part that:
The plan of care and results of treatment are reviewed by the physician or
by the individual who
established the plan at least as often as the patientþs condition requires,
and the indicated action is taken.
(For Medicare patients, the plan must be reviewed by a physician in accordance
with 424.25(e) of this
chapter.)
42 C.F.R. 405.1717(b)(3).
The reference to 42 C.F.R. 424.25(e) is inaccurate. The section has been superseded
by 42 C.F.R.
410.61(e). This section states as follows:
(e) Review of the plan:
(1) The physician reviews the plan [of care] as often as the individualþs
condition
requires, but at least every 30 days.
(2) Each review is signed and dated by the physician who performs it.
HCFA asserts that 42 C.F.R. 405.1717, read with 42 C.F.R. 410.61(e), must be
interpreted to require
that each plan of care that is created by an outpatient physical therapy and
rehabilitation provider must be
approved and signed and dated at the inception of the plan of care, by the physician
on whose orders the
plan is made. HCFA asserts also that 42 C.F.R. 405.1717 requires an outpatient
physical therapy and
rehabilitation provider obtain a written order by a physician, in addition to
having the plan of care reviewed
and approved and signed and dated by the physician, before providing physical
therapy to a patient. HCFA
posthearing memorandum at 34 - 35.
The regulation contains no language which suggests that a physician must review,
approve, sign and date a
plan of care prior to the initiation of therapy. The regulation explicitly authorizes
a physical therapist to
implement treatment pursuant to a plan of care prepared by the physical therapist.
The plain meaning of
the regulation is that, in the case of a Medicare beneficiary, a physician must
review the plan of care at
some point, but no later than 30 days, after inception of treatment. This reading
is entirely consistent with
the regulationþs language permitting a physical therapist to establish
a plan of care. It is consistent also
with the requirements of section 1861(p) of the Act.
Furthermore, I do not agree with HCFAþs contention that the patientþs
record must contain both an order
for physical therapy signed by a physician and an initial plan of care signed
by the physician and by the
physical therapist. The physicianþs signature on a plan of care alone
is ample evidence that the physician
ordered and approved that care. Thus, a physicianþs approval of the administration
of physical therapy to a
patient would be evidenced either by a physicianþs order for physical
therapy, or by a physicianþs
signature on the initial plan of care for physical therapy.
2. The evidence of Petitionerþs compliance with the plan of care regulation
Although I do not agree with HCFAþs interpretation of 42 C.F.R. 405.1717,
I have used that
interpretation to weigh the credible evidence of Petitionerþs conduct.
HCFA has not proved that Petitioner
failed to comply with HCFAþs interpretation of the regulation.
HCFA contends that evidence, consisting of HCFA Ex. 17 - 35, proves that Petitioner
did not comply with
HCFAþs interpretation of the plan of care regulation. It alleges that
in 19 of the 20 records reviewed by
Mr. End, the initial plan of care was not signed by a physician. It alleges
also that in 10 of the 20 records
reviewed by Mr. End there was no physician order for physical therapy predating
the inception of
treatment.
That may be so. However, as I conclude at part III.C. of this decision, the
more credible evidence of
Petitionerþs performance under the conditions of participation is P. Ex.
9 - 28. These exhibits are the best
evidence of the care that was provided to Petitionerþs patients. They
prove that Petitioner was complying
with HCFAþs interpretation of the plan of care regulation. Every one of
these exhibits contains a plan of
care signed by a physician. P. Ex. 9 at 3; P. Ex. 10 at 3; P. Ex. 11 at 4; P.
Ex. 12 at 3; P. Ex. 13 at 3; P. Ex.
14 at 3; P. Ex. 15 at 3; P. Ex. 16 at 3; P. Ex. 17 at 2; P. Ex. 18 at 2; P.
Ex. 19 at 2; P. Ex. 20 at 3; P. Ex. 21
at 3; P. Ex. 22 at 3; P. Ex. 23 at 3; P. Ex. 24 at 3; P. Ex. 25 at 3 - 4; P.
Ex. 26 at 2; P. Ex. 27 at 2; P. Ex. 28
at 3. As I explain below, there is no requirement that there be both a physician's
approval of the initial plan
of care and a physician's order for physical therapy. However, nearly all of
these exhibits also contain a
written order for physical therapy.
I conclude from P. Ex. 9 - 28 that Petitioner was providing physical therapy
to its patients pursuant to the
approval and direction of physicians. I conclude also that the plans of care
for physical therapy that were
developed by therapists employed by Petitioner were reviewed and approved by
physicians.
3. Evidence as to the level of deficiency
As I find at part III.A.2. of this decision, in order to prove a condition
level deficiency, HCFA must prove
that a deficiency is of such character as to substantially limit the Petitionerþs
capacity to render adequate
care or that it adversely affects the health and safety of patients. 42 C.F.R.
488.24(a). However, there
can be no finding of a condition level deficiency where the evidence does not
prove any deficiency.
Inasmuch as HCFA did not prove that Petitioner failed to comply with the plan
of care regulation, it
follows that HCFA failed to prove that Petitioner did not comply with the condition
of participation that is
stated in that regulation.
I would note, however, that HCFAþs assertion of a condition level deficiency
is premised on Mr. Endþs
conclusion that Petitioner was not providing physical therapy to its patients
under the direction of a
physician. Tr. at 118. I agree with HCFA that the Act and regulations contemplate
that a physician will
exercise control over the physical therapy that is provided to a beneficiary.
However, the evidence in this
case does not prove that Petitioner failed to assure physician direction and
control over the physical therapy
that it provided to beneficiaries.
E. HCFAþs allegation that Petitioner did not comply with the condition
of participation
governing clinical records contained in 42 C.F.R. 405.1722 (Finding 6)
I have evaluated HCFAþs allegation that Petitioner did not comply with
the condition of participation
governing clinical records contained in 42 C.F.R. 405.1722 pursuant to the three
elements of HCFAþs
burden of persuasion. HCFA proved that, in some respects, Petitioner did not
comply with a standard in
the regulation which requires that medical records be completed promptly. However,
HCFA did not prove
that the failure by Petitioner to comply with this standard was so egregious
as to contravene a condition of
participation. 42 C.F.R. 488.24(a).
1. The requirements of the clinical records regulation
HCFA argues that the clinical records regulation contains two requirements
that are relevant here. First,
HCFA argues that the regulation implicitly requires an outpatient physical therapy
and rehabilitation
provider to maintain its treatment records, or at least contemporaneous copies
of those records, at a central
location. HCFA asserts that, in this case, the central location is Petitionerþs
Lakewood, New Jersey office.
I addressed HCFA's argument that Petitioner must centralize copies of its records
at part III.B. of this
decision and found it not to be persuasive.
Second, HCFA argues that the regulation requires an outpatient physical therapy
and rehabilitation
provider to complete its patient records promptly. I agree with HCFA that there
is a standard in the
regulation which requires a provider to complete all clinical records promptly.
The Act does not set forth detailed clinical records requirements for outpatient
physical therapy and
rehabilitation providers. It provides only that such providers must maintain
clinical records. Act, section
1861(p)(4)(A)(iii). The clinical records regulation is intended to implement
this statutory requirement. It
provides, as a condition of participation, that an outpatient physical therapy
and rehabilitation provider
must maintain:
clinical records on all patients in accordance with accepted professional
standards, and practices. The
clinical records are completely and accurately documented, readily accessible
and systematically organized to facilitate retrieving and compiling information.
42 C.F.R. 405.1722.
A standard of this regulation requires that an outpatient physical therapy
and rehabilitation provider must
assure that clinical records are þcompleted promptly.þ 42 C.F.R.
405.1722(c).
HCFA interprets the prompt completion requirement of 42 C.F.R. 405.1722(c)
to mean that a clinical
record must be signed by a physician, where a physicianþs signature is
required, within 14 days from
generation of the record. HCFA posthearing memorandum at 32. HCFA bases this
argument on Mr.
Endþs experience, both as a nurse and as a surveyor, and on New Jersey
regulations which govern physical
therapy. Tr. at 88; N.J. Admin. Code tit. 13, 39A-2.1. Petitioner has not offered
evidence to contradict
that on which HCFA relies. I find that HCFA proved that the accepted practice
is to complete a clinical
record within 14 days of its generation. Where completion means a signature,
then the record must be
signed within 14 days of its generation. Therefore, I agree with HCFAþs
interpretation of the prompt
completion requirement of 42 C.F.R. 405.1722(c).
HCFA argues that the regulation requires that, where a physicianþs signature
appears in a clinical record,
that signature must be dated. I do not read this general requirement into the
regulation. There is a
requirement that a progress review of a plan of care be signed and dated by
the physician who performs the
review. 42 C.F.R. 405.1717(b)(3), incorporating 42 C.F.R. 410.61(e)(2). But
that requirement does not
attach to other records that are signed by a physician. The regulation states
only that: þEach physicianþs
entries into the clinical record are signed by the appropriate physician.þ
42 C.F.R. 405.1722(c)
2. Petitionerþs records
HCFA asserts that Petitioner failed, systematically, to comply with the prompt
completion requirement of
42 C.F.R. 405.1722(c). HCFA bases its assertion on its analysis of HCFA Ex.
17 - 35. HCFA contends
that these exhibits establish a general failure by physicians to sign plans
of care or orders for physical
therapy.
As I hold above, the more credible evidence of Petitionerþs records is
in P. Ex. 9 - 28. I have examined
these records in light of the requirements of 42 C.F.R. 405.1722(c). These records
establish that: (1) in
some instances, physicians signed records more than 14 days after their creation;
(2) in many instances,
physicians signed records and dated their signatures; and (3) in many other
instances, physicians signed
records without dating their signatures. There also are records in some exhibits
which appear not to have
been signed by physicians, although they should have been. However, in no exhibit
do I find a pattern of
failure by the treating physician to sign requisite records.
For example, in P. Ex. 9 (the corresponding HCFA exhibit is HCFA Ex. 26), the
physician signed and
dated an order for physical therapy. P. Ex. 9 at 2 (the date of the signature
is illegible). The physician
signed and dated the initial plan of care for physical therapy. Id. at 3. However,
the plan is dated January
25, 1995, and the physician signed it on March 7, 1995. Id. The physician signed
and dated a transfer for
the patient from a hospital to a nursing home. Id. at 5. This document includes
directions for
administration of physical therapy to the patient. Id. The physician also signed
and dated various
physicianþs orders. Id. at 6. Finally, the physician signed and dated
a plan of treatment for outpatient
rehabilitation. Id. at 7 - 8. The date of the physicianþs signature on
this document is not clear, but it
appears to be April 20, 1995. Id. The plan of treatment was executed by the
physical therapist on January
25, 1995. Id.
The other exhibits introduced by Petitioner as examples of its records contain
a similar pattern of
signatures. P. Ex. 10 - 28. I conclude from my review of these exhibits that
Petitioner failed to comply
with the standard of participation contained in 42 C.F.R. 405.1722(c), in that
there are a substantial
number of instances in which physicians signed documents more than 14 days after
their creation. That is
evident from the dates of the physiciansþ signatures, to the extent that
the signatures are dated. P. Ex. 9 at
3. I do not conclude, however, that these exhibits prove a wholesale failure
by physicians to sign their
orders or to review the treatments provided by physical therapists. To the contrary,
the records
demonstrate physician involvement in the physical therapy provided to the patients
treated by Petitioner.
3. Evidence as to the level of deficiency
HCFA proved that Petitioner did not comply with the standard of participation
in 42 C.F.R. 405.1722(c).
It does not follow, necessarily, that Petitionerþs failure to comply with
a standard of participation is also a
failure by Petitioner to comply with the condition of participation which includes
the standard. Where
HCFA proves that a provider fails to comply with a standard of participation,
HCFA must prove that the
deficiency is so serious as to comprise a condition level deficiency, within
the meaning of 42 C.F.R.
488.24(a). Nazareno Medical Hospice Fajardo, Caguas, Cayey, DAB CR386, at 15
- 16 (1995); Hospicio
en el Hogar de Utuado, DAB CR371, at 12 (1995).
HCFA asserts that it is reasonable to infer from Petitionerþs failure
to assure that its records were
completed promptly, that physicians were derelict in their responsibility to
oversee and monitor the
physical therapy that Petitioner was providing to beneficiaries. HCFA posthearing
memorandum at 44 -
45. From this, it argues that beneficiaries were being provided physical therapy
that either might not be
beneficial to them, or which placed them at risk. Id.
I agree with HCFA that, if the evidence in this case proved a failure by Petitioner
to assure that physicians
oversee and monitor the physical therapy that Petitioner was providing to beneficiaries,
that failure would
be a condition-level deficiency. In enacting section 1861(p) of the Act, Congress
thought it necessary that
the administration of physical therapy be monitored by a physician. However,
I do not find that HCFA
proved the premise of its assertion that Petitioner failed to comply with a
condition of participation. As I
conclude at Part III.E.2. of this decision, the failures of physicians to sign
or date all clinical records in
some instances do not establish a pattern of dereliction of responsibility by
physicians. To the contrary, the
clinical records in evidence as P. Ex. 9 - 28 show a substantial degree of involvement
by a physician in
each case.
IV. Conclusion
I conclude that HCFA did not prove that Petitioner failed to comply with a
condition of participation.
Therefore, HCFA did not establish a basis for terminating Petitioner's participation
in Medicare.
________________________
Steven T. Kessel
Administrative Law Judge
1. The regulations governing survey, certification, and enforcement procedures
were revised, effective
July 1995. 59 Fed. Reg. 56116, 56237 (1994). My citations to survey, certification,
and enforcement
regulations in this decision, including regulations in 42 C.F.R. Part 488, are
to regulations which were in
effect before July 1995, inasmuch as the actions at issue occurred prior to
that date. However, the revised
regulations would not appear to direct a different outcome.
2. Mr. End testified at the hearing of this case. Tr. at 41 - 159.
3. HCFA cites my decision in SRA, Inc. as support for this argument. HCFA posthearing
memorandum
at 20. It does so, notwithstanding that the case is distinguishable from this
case, and also notwithstanding
that I noted the distinction in my Nazareno decision. In SRA, Inc., an applicant
to participate as a supplier
of Medicare services challenged HCFAþs determination of the effective
date of its participation. The case
did not involve termination of participation, as was the case in Nazareno, and
is the case here.
4. HCFA asserts that Petitioner builds its case around the argument that HCFA's
surveyor should have
visited the eight long-term care facilities to review Petitionerþs treatment
records at those facilities. HCFA
posthearing memorandum at 45. This does not characterize accurately Petitionerþs
argument. Petitioner is
basing its evidentiary case on its allegation that HCFA's surveyor did not ask
to review Petitioner's patient
treatment records on April 5, 1995. Below, part III.C. of this decision, I discuss
this issue and explain why
I find Petitioner's allegation to be credible.
5. However, the surveyor might have performed a more thorough survey of Petitioner
had he visited at
least one of the facilities at which Petitioner furnishes care. I take notice
of
the fact that one of the facilities at which Petitioner provides care, Mercer
County Geriatric Center, is
located in the same county in New Jersey as is the offices of the New Jersey
Department of Health.
6. At part III.C. of this decision, I discuss HCFAþs allegation that,
on April 5, 1995, the State Agency
surveyor requested Petitioner to fax treatment records from the eight long-term
care facilities to
Petitionerþs Lakewood office for review by the surveyor. I discuss also
my reasons for concluding that the
allegation is not credible.
7. HCFA does not contend that it reviewed Petitionerþs treatment files
in order to ascertain whether
Petitioner complied with this promise.
8. HCFA offers no explanation for the surveyor's finding.
9. The different versions of treatment records correspond as follows: HCFA
Ex. 17 - P. Ex. 17;
HCFA Ex. 18 - P. Ex. 27; HCFA Ex. 19 - P. Ex. 20; HCFA Ex. 20 - P. Ex. 28; HCFA
Ex. 21 - P. Ex. 10;
HCFA Ex. 22 - P. Ex. 21; HCFA Ex. 23 - P. Ex. 22; HCFA Ex. 24 - P. Ex. 15; HCFA
Ex. 25 - P. Ex. 12;
HCFA Ex. 26 - P. Ex. 9; HCFA Ex. 27 - P. Ex. 26; HCFA Ex. 28 - P. Ex. 25; HCFA
Ex. 29 - P. Ex. 24;
HCFA Ex. 30 - P. Ex. 18; HCFA Ex. 31 - P. Ex. 16; HCFA Ex. 32 - P. Ex. 23; HCFA
Ex. 33 - P. Ex. 14;
HCFA Ex. 34 - P. Ex. 13; and HCFA Ex. 35 - P. Ex. 19. Petitioner also introduced
a treatment record for
which there is no corresponding HCFA exhibit--P. Ex. 11.
10. Mr. Livesay did not testify in this case, nor did HCFA introduce into evidence
a statement by
Mr. Livesay. Therefore, Mr. End's testimony, and also the testimony of Dr. Akinrolabu,
is not
corroborated by that of any other witness.
11. HCFA did not discuss the implications of section 1814(a) of the Act.