$05:Civil Money Penalty
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
Hospicio en el Hogar de Utuado,
Petitioner,
- v. -
Health Care Financing Administration.
DATE: April 24, 1995
Docket No. C-94-360
Decision No. CR371
DECISION
Petitioner requested a hearing from a determination by the Health
Care Financing Administration (HCFA) to terminate Petitioner's
participation in the Medicare program. The case was assigned to me
for a hearing and a decision. On November 1, 1994, I conducted a
hearing in San Juan, Puerto Rico.
I have considered the applicable law and regulations, the evidence
which I received at the hearing, and the parties' arguments. 1/ I
conclude that HCFA proved, by a preponderance of the evidence, that
Petitioner failed to comply with conditions governing its
participation in Medicare. Therefore, HCFA was authorized to
terminate Petitioner's participation in Medicare.
I. Issues, findings of fact, and conclusions of law
The issue in this case is whether HCFA was authorized to terminate
Petitioner's participation in the Medicare program. In deciding
that HCFA was authorized to terminate Petitioner's participation,
I make specific findings of fact and conclusions of law. After
each finding or conclusion, I cite to the page or pages of the
decision at which I discuss the finding or conclusion.
1. In a case where a provider requests a hearing from a
determination by HCFA to terminate its participation in Medicare,
HCFA must prove, by a preponderance of the evidence, that the
determination to terminate the provider's agreement is authorized.
Pages 6 - 10.
2. The elements of HCFA's burden of persuasion consist of
proving that:
a. There exist participation requirements to which
Petitioner may be held accountable. Pages 10 - 11.
b. Petitioner has not complied with Medicare
participation requirements. Pages 11 - 12.
c. Petitioner's failure to comply with Medicare
participation requirements substantially limits Petitioner's
capacity to render adequate care or adversely affects the health
and safety of Petitioner's patients. Pages 12 - 13.
3. HCFA did not deny Petitioner due process when it
terminated Petitioner's participation in Medicare after a May 6,
1994 resurvey of Petitioner without first affording Petitioner the
opportunity to correct deficiencies that were identified at the
resurvey. Pages 13 - 15.
4. HCFA proved, by the preponderance of the evidence, that
Petitioner failed to comply with conditions of participation in the
Medicare program. HCFA proved that Petitioner failed to comply
with conditions:
a. establishing the duties of the medical director of
a hospice, contained in 42 C.F.R. 418.54. Pages 21 - 25.
b. requiring the creation and revision of a plan of
care for each patient of a hospice, contained in 42 C.F.R.
418.58. Pages 25 - 28.
c. defining the duties of a hospice's
interdisciplinary group, contained in 42 C.F.R. 418.68. Pages
28 - 29.
5. HCFA was authorized to terminate Petitioner's
participation in the Medicare program. Pages 29 - 30.
II. Discussion
A. Background
Petitioner is a hospice, operating in Utuado, Puerto Rico. A
hospice is described under section 1861(dd)(1) of the Social
Security Act (Act) as a Medicare provider which offers care and
services to a terminally ill beneficiary pursuant to a written plan
of care established and periodically reviewed by the beneficiary's
attending physician, the hospice's medical director, and its
interdisciplinary group. 2/
A hospice provides its care and services in the beneficiary's home,
on an outpatient basis, and, in some instances, on a short-term
inpatient basis. Act, section 1861(dd)(2)(A)(ii). Hospice
services include: nursing care, physical and other therapy,
medical social services, home health aide services, medical
supplies, physicians' services, short-term inpatient care, and
counseling. Id., section 1861(dd)(1)(A) - (H). In addition, a
hospice provides bereavement counseling for the immediate family of
a terminally ill beneficiary. Id., section 1861(dd)(2)(A)(i).
On March 10, 1994, Petitioner was surveyed on behalf of HCFA by the
Puerto Rico Department of Health. HCFA Ex. 15 at 1. The purpose
of the survey was to determine whether Petitioner was complying
with the requirements of the Medicare program.
On March 23, 1994, HCFA advised Petitioner that it had determined
that Petitioner was not complying with Medicare conditions of
participation. HCFA Ex. 15 at 1. HCFA advised Petitioner that it
had determined that Petitioner was not complying with seven
conditions governing Petitioner's participation in Medicare. Id.
These conditions are found in the following regulations: 42 C.F.R.
418.50 (general provisions); 418.54 (medical director); 418.58
(plan of care); 418.62 (informed consent); 418.80 (core services);
418.86 (physician services); and 418.92 (physical therapy,
occupational therapy, and speech-language pathology). 3/
HCFA advised Petitioner that, based on the findings that Petitioner
was not complying with conditions of participation in Medicare,
HCFA intended to terminate Petitioner's participation as a provider
of services in the Medicare program. However, HCFA invited
Petitioner to submit a plan of correction to HCFA to correct the
deficiencies that had been identified at the March 10 survey. HCFA
Ex. 15 at 2. HCFA implied that, if Petitioner submitted a plan of
correction which HCFA found to be acceptable, and the deficiencies
were found to be corrected at a resurvey of Petitioner, then HCFA
would not terminate Petitioner's participation in Medicare. Id.
On April 7, 1994, Petitioner submitted a plan of correction to
HCFA. HCFA Ex. 16. On April 19, 1994, HCFA notified Petitioner
that HCFA had found the plan not to be fully acceptable. HCFA Ex.
17. In this communication to Petitioner, HCFA advised Petitioner
that it could submit a revised plan of correction within 10 days.
Id. There is no evidence that Petitioner submitted a revised plan
of correction to HCFA.
On May 6, 1994, HCFA conducted a second survey of Petitioner in
order to determine whether Petitioner was complying with the
requirements for participation in Medicare. HCFA found that
Petitioner continued to be noncompliant with conditions of
participation in Medicare. HCFA Exs. 18, 19. The conditions of
participation which HCFA found Petitioner to continue to contravene
are contained in regulations at 42 C.F.R. 418.50 (general
provisions); 418.54 (medical director); 418.58 (plan of care); and
418.68 (interdisciplinary group). On May 23, 1994, HCFA advised
Petitioner of these findings, and advised it further that HCFA had
affirmed its previous determination to terminate Petitioner's
participation in the Medicare program. HCFA Ex. 19.
This case addresses the issue of whether HCFA was authorized to
terminate Petitioner's participation in Medicare due to
Petitioner's failure to comply with any of the four conditions of
participation which HCFA found Petitioner not to be complying with,
based on the May 6, 1994 resurvey of Petitioner.
Petitioner's alleged previous failure to comply with other
conditions of participation is not at issue. 4/
B. The parties' arguments as to issues of law
This case involves issues of law concerning the interpretation and
application of the Act and relevant regulations. I decided some of
these same issues in Arecibo Medical Hospice Care, DAB CR363 (1995)
and in Hospicio en el Hogar de Lajas, DAB CR366 (1995). 5/ As to
those issues, I reach the same conclusions here as I did in Arecibo
and Lajas.
1. Burden of persuasion
a. Allocation to HCFA of the burden of persuasion
In Arecibo and Lajas, I held that HCFA had the burdens of coming
forward with evidence and proving, by the preponderance of the
evidence, that its determination to terminate the providers'
participation in Medicare was justified. 6/ Arecibo at 8 - 13;
Lajas at 6 - 8. I conclude the same here. I do not agree with
HCFA's argument that the burden of persuasion should be allocated
to Petitioner.
Neither the Act nor regulations governing hearings in provider
termination cases specifically allocate the burden of persuasion to
a particular party. Act, sections 205(b), 1866(b)(2)(A), (h)(1);
42 C.F.R. Part 498; Lajas at 6. However, the Secretary has given
administrative law judges broad authority to manage the
presentation and receipt of evidence in hearings concerning whether
terminations of participation are justified. 42 C.F.R.
498.60(b)(3). From this, I conclude, as I did in Arecibo and
Lajas, that administrative law judges who preside over hearings
concerning the propriety of terminations of participation in
Medicare have discretion to allocate the burden of persuasion
consistent with the requirements of due process.
It is both consistent with the requirements of due process and
efficient to allocate to HCFA the burdens of coming forward and
proving, by a preponderance of the evidence, that Petitioner failed
to comply with conditions of participation in Medicare. As I held
in Arecibo and Lajas, in a termination case, HCFA will have
obtained from a survey of the provider the facts which HCFA
believes justify the determination that the provider is not
complying with conditions of participation. HCFA is thus in the
best position to identify the facts which support its determination
and to prove those facts.
Allocating the burden of persuasion to the provider would be
neither fair nor efficient. The provider would be placed in the
position of having to prove a negative proposition -- that it did
not fail to comply with conditions of participation -- without
knowing what or how much evidence might be necessary to establish
that proposition. Allocating the burden of persuasion to the
provider would invite a massive and unfocused submission of
evidence from the provider.
HCFA advances two arguments to support its assertion that the
burden of persuasion should be allocated to Petitioner. HCFA's
first argument is that the administrative hearing is essentially an
appellate review of the interpretations of law and the findings of
fact of the State agency surveyors who performed the survey on
which HCFA bases its determination to terminate a provider's
participation.
HCFA asserts that the surveyors must be deferred to because they
have professional expertise. HCFA posthearing memorandum at 25 -
28. HCFA argues that, given the professional expertise of the
surveyors, their interpretations of regulations and their fact
findings and opinions are presumptively correct and must be
accorded "immense weight." Id. at 28. Based on this analysis,
HCFA argues that a provider who challenges a surveyor's
interpretation of a regulation, or who challenges a surveyor's
findings of fact, must prove that the surveyor's interpretation or
findings are "clearly erroneous" in order to prevail. Id. HCFA
asserts, alternatively, that findings made by surveyors must be
sustained if they are supported by "substantial evidence." Id. at
8.
This analysis mischaracterizes the purpose of the administrative
hearing guaranteed to providers by Congress. It mischaracterizes
also the role of the State agency surveyors in conducting
inspections on behalf of HCFA. HCFA's characterization of the
hearing as an appellate review of interpretations and findings made
by surveyors ignores the fact that Congress directed that providers
whose participation in Medicare is terminated by HCFA be afforded
de novo hearings. Congress directed that the provider whose
participation in Medicare is terminated under the authority of
section 1866(b) of the Act be afforded a right to a hearing to the
same extent as that which is offered to claimants for Social
Security benefits under section 205(b) of the Act. Act, section
1866(h)(1). Section 205(b) has been interpreted uniformly and
often as conferring a right to a de novo hearing.
The purpose of an administrative hearing in a case involving a
determination by HCFA to terminate a provider's participation under
the authority of section 1866(b) of the Act is to decide whether
the applicable law and the evidence establish a basis for
termination. In a de novo hearing, no presumption of correctness
attaches to HCFA's determination. The administrative law judge
must evaluate the law and evidence independently.
The regulations which govern surveys of providers by State agency
surveyors provide that surveyors are "professionals who use their
judgment, in concert with Federal forms and procedures, to
determine compliance
. . . ." 42 C.F.R. 488.26(a)(3). The regulations affirm that
surveyors are supposed to have expertise in the activities of the
providers which they survey, as well as knowledge of applicable law
and regulations. Surveyors are expected to use their expertise in
conducting surveys and in evaluating the facts that they uncover at
surveys.
In a hearing concerning the results of a survey, a surveyor may
qualify as an expert witness. 7/ His or her opinion as to the
meaning of facts may be instructive, particularly as to the effect
that failure by a provider to comply with Medicare participation
requirements may have on that provider's ability to provide care to
patients consistent with the requirements of the Act and
regulations. The credible opinion of a surveyor as to an issue of
fact may be dispositive if not rebutted by evidence offered by the
provider.
But the fact that surveyors may qualify as expert witnesses does
not suggest that they have been vested with the authority to
interpret the law on behalf of the Secretary. Neither does it
suggest that their opinions are entitled to a presumption of
correctness. There is nothing in the Act or in regulations that
vests State agency surveyors with authority to interpret law or
which requires their opinions to be afforded special weight.
HCFA's second argument is that a provider whose participation in
Medicare has been terminated by HCFA should be regarded as an
applicant for relief, benefits, or a privilege. HCFA couples this
characterization of providers with the general principle of
administrative law that, in administrative hearings, the burden of
persuasion is on the applicant, to argue that the burden of
persuasion falls on Petitioner.
HCFA made the identical argument in Arecibo and Lajas. I found it
to be unpersuasive in both cases. Arecibo at 11 - 13; Lajas at 7
- 8. It is not reasonable to characterize a provider as an
"applicant" who seeks relief, benefits, or a privilege from HCFA.
It is a much more accurate characterization to view the provider as
having a quasi-contractual relationship with Medicare that HCFA
intends to terminate. In a case involving a determination to
terminate a provider's participation in Medicare, the provider has
already received a privilege from HCFA which HCFA has determined to
extinguish. That provider's ongoing business activities -- and, in
some cases, its very existence -- will be ended as a consequence of
HCFA's termination of the provider's participation in Medicare.
A provider does not have an unqualified right to retain its
provider status. A provider's relationship with HCFA and the
Medicare program is governed by the Act, regulations, and the
provider agreement. HCFA may terminate a provider's participation
in Medicare when the provider has not complied substantially with
the requirements of participation.
In Arecibo and Lajas, I discussed the authorities which HCFA relies
on to support its characterization of Petitioner as an "applicant."
Arecibo at 10 - 13; Lajas at 8. I concluded that those authorities
were not persuasive. The text on administrative law and the
judicial decisions cited by HCFA to support its argument restate
the general principle that, in an administrative hearing, the
burden of persuasion should be allocated to the applicant. I am
not questioning those authorities.
However, for the reasons I have explained above, it is not
reasonable to characterize Petitioner as an "applicant."
HCFA relies also on a decision by the Appeals Council of the Social
Security Administration Office of Hearings and Appeals, Jefferson
Memorial Hosp. Ass'n v. Health Care Financing Administration,
Docket No. PS-109, at 17 (1983), to support its argument that the
burden of persuasion should be allocated to Petitioner. As I
explained in Arecibo, I do not find that decision to be persuasive
authority to allocate the burden of persuasion to Petitioner.
Indeed, it may be read to support my conclusion that the burden of
persuasion should be allocated to HCFA. Arecibo at 12 - 13.
b. The elements of HCFA's burden of persuasion
HCFA's burden of persuasion in a case involving a determination to
terminate a provider's participation in Medicare consists of three
elements. The three elements are: (1) the existence of
participation requirements which Petitioner allegedly has not
complied with; (2) the facts which establish that Petitioner has
failed to comply with a Medicare participation requirement; and (3)
that Petitioner's failure to comply with participation requirements
is so substantial as to justify terminating Petitioner's
participation in Medicare.
First, HCFA must prove the existence of the participation
requirements which it alleges that Petitioner has not complied
with. Participation requirements are stated both in the Act and in
implementing regulations. For example, 42 C.F.R. Part 418 contains
numerous regulations which express both conditions and standards of
participation for a hospice.
If HCFA is relying on the plain language of a section of the Act or
a regulation, it need only identify that language in order to meet
this first element of its burden of persuasion. For example, in
Arecibo and Lajas, HCFA asserted that the providers failed to
comply with the plain language of 42 C.F.R. 418.58(b), a section
which governs the way in which hospices are required to review
patient plans of care and to document their reviews. Arecibo at 19
- 22; Lajas at 17 - 18.
HCFA assumes additional burdens when it relies on an interpretation
of law that is not apparent from the plain meaning of the law. In
that event, HCFA must prove that its interpretation is reasonable
and that the provider had notice of that interpretation.
In both Arecibo and Lajas, I held that the Secretary delegated
authority to HCFA to interpret reasonably the criteria which
governed the participation of providers. Arecibo at 22; Lajas at
12 - 13. There may be ambiguities in some regulations which are
susceptible to reasonable interpretation by HCFA. However, the
authority to interpret regulations does not translate into
authority to write requirements into regulations which are not
reasonably described by the language of those regulations. HCFA
does not have the authority to use the vehicle of interpretation to
create participation requirements which exceed the specific
requirements of the Act or regulations. Nor does HCFA have
authority to interpret ambiguous language in a way that is not
reasonable.
HCFA has the duty to communicate its reasonable interpretations of
the Act or regulations to providers as a prerequisite to holding
providers accountable for complying with those interpretations. In
Arecibo and Lajas, I held that HCFA could not hold the providers
responsible for complying with an interpretation of a regulation
which was not apparent from the face of the regulation and which
HCFA had not communicated to the providers. Arecibo at 25; Lajas
at 13.
HCFA argues that providers have a duty to comply with applicable
participation requirements. HCFA asserts that this duty extends to
complying with HCFA's interpretations of law even if HCFA does not
communicate these interpretations to providers. I do not disagree
with HCFA that providers are obligated to comply with HCFA's
interpretations of the law, where HCFA interprets the law
reasonably, and where HCFA puts providers on notice of its
interpretations. However, providers are not obligated to divine
HCFA's interpretation of a law where the interpretation, albeit
reasonable, is not apparent from the face of the law, and where
HCFA has not communicated the interpretation to providers.
HCFA asserts that I have held previously that providers have the
duty to comply with HCFA's interpretations, citing my decision in
Long Medical Laboratory, DAB CR334, at 11 - 12 (1994). In the Long
Medical Laboratory case, I held that the provider had a duty to
comply with an unambiguous and explicit requirement of the Act.
Where a requirement stated in the Act or in a regulation is
explicit, HCFA has no obligation to communicate the requirement to
a provider as a prerequisite to holding the provider accountable to
it. But, the Long Medical Laboratory decision did not hold that
HCFA may hold a provider accountable to an interpretation of law
which is not apparent from the plain meaning of the enactment,
without first communicating that interpretation to the provider.
The second element of HCFA's burden of persuasion is to prove the
facts which establish that a provider has failed to comply with a
Medicare participation requirement. The evidence which proves
these facts may consist of the testimony of surveyors as to the
findings that they made when they surveyed the provider. It may
consist also of supporting materials, such as patient records,
obtained by the surveyors from the provider.
HCFA must establish contested facts by a simple preponderance of
the evidence. In other words, the weight of the evidence offered
by HCFA must be sufficient to establish a prima facie case and to
overcome any rebuttal evidence offered by the provider.
Finally, HCFA must prove, again by a preponderance of the evidence,
that a provider's failure to comply with participation requirements
is so substantial as to justify terminating the provider's
participation in Medicare. The Act authorizes the Secretary to
terminate a provider's participation in Medicare where the provider
fails to comply substantially with the provisions of the provider
participation agreement, the Act, and implementing regulations, or
with a mandated corrective action plan. Act, section
1866(b)(2)(A). The Secretary has delegated this authority to HCFA.
42 C.F.R. 489.53(a)(1), (3).
The Act does not define what is meant by failure to comply
substantially. Regulations establish a test for substantial
noncompliance by stating that a provider will be found to have
failed to comply with conditions of participation in Medicare where
its deficiencies are of such character as to substantially limit
its capacity to render adequate care or where they adversely affect
the health and safety of patients. 42 C.F.R. 488.24(a). Thus,
in order to prove a basis to terminate a provider's participation
in Medicare, HCFA must prove that the provider's deficiencies are
substantial within the meaning of 42 C.F.R. 488.24(a).
Termination of participation is a remedy to protect against
possible future failures of performance by a provider, and not a
punishment for past wrongs. In any case in which HCFA seeks to
justify terminating a provider's participation in Medicare, the
ultimate question is whether the deficiencies established by HCFA
predict a likelihood that the provider will not be able to deliver
care in the future consistent with the requirements of the Act and
regulations. The Act and regulations make it plain, however, that
an inference may be drawn from substantial failure by a provider to
comply with participation requirements that the provider is likely
to remain deficient.
There are circumstances where the impact of a provider's deficiency
on that provider's capacity to provide care or on the health and
safety of patients is evident from the deficiency itself. For
example, in Arecibo and Lajas, I held that the providers' failure
to schedule reviews of patient plans of care or to document reviews
of those plans constituted failure to comply with a basic
requirement of hospice operations, that being the need to plan the
care provided to patients and to monitor and evaluate the effects
of the care that the patients were receiving from the hospice and
its personnel. Arecibo at 26; Lajas at 19 - 20. The providers'
failure to plan care was on its face a failure to comply with a
fundamental prerequisite for participation in the Medicare program.
It was apparent from the failure of the providers to plan their
patients' care that they were not capable of providing care
consistent with the requirements of the Act and regulations.
There may be circumstances where the impact of a deficiency on a
provider's ability to provide care or on the health and safety of
patients is not apparent from the facts establishing the existence
of the deficiency. A finding that a provider has violated a
condition of participation does not necessarily flow automatically
from a finding that the provider has not complied with a Medicare
participation requirement. See Lajas at 19. Moreover, evidence of
isolated examples of deficiencies in providing care may not be
sufficient to establish an overall failure by the provider to
provide care consistent with the requirements of the Act or
regulations.
Thus, in some cases, HCFA may have to prove not only the existence
of a deficiency, but may have to offer additional evidence to prove
that the deficiency is substantial within the meaning of 42 C.F.R.
488.24(a) and the Act. That evidence may consist of evidence which
proves the impact of the deficiency on the provider's ability to
provide care or on the health and safety of patients. In proving
impact, expert opinion as to the likely impact of the deficiency on
the capacity of the provider to provide care may be important.
2. Alleged denial of due process to Petitioner
Petitioner asserts that HCFA denied Petitioner the opportunity to
comply with Medicare participation requirements, in violation of
the requirements of 42 C.F.R. 488.28. Petitioner posthearing
brief at 7 - 9. This alleged failure by HCFA, according to
Petitioner, denied Petitioner due process. Id. The providers in
Arecibo and Lajas made the same argument. Arecibo at 5 - 8; Lajas
at 8 - 10. In both of those cases, I found the argument to be
unpersuasive. Id. I find the argument to be unpersuasive in this
case as well.
Petitioner bases its argument on its contention that, at the May 6,
1994 resurvey, the surveyors found Petitioner to be out of
compliance with a standard contained in a regulation which the
surveyors who conducted the March 10, 1994 survey had not cited as
a basis for their conclusion that Petitioner was deficient. 8/
According to Petitioner, the fact that it was found to be deficient
with respect to a standard not cited previously, gave it the right
to submit a new plan of correction to HCFA to address that
deficiency and all other deficiencies that were identified at the
May 6, 1994 resurvey.
The regulation that Petitioner relies on to support its argument is
42 C.F.R. 488.28. This regulation provides that, where HCFA
determines that a provider is not complying with a standard of
participation established in a regulation, it will give that
provider an opportunity to submit a plan of correction explaining
how the provider will correct the deficiency.
The regulations which govern a provider's participation in Medicare
as a hospice state broad conditions of participation in the
Medicare program. 42 C.F.R. Part 418. For each of the conditions,
the regulations state specific performance criteria as subparts.
These performance criteria are the standards which are referred to
in 42 C.F.R. 488.28. In surveying a provider for compliance
with Medicare participation requirements, HCFA may determine that
a provider is not complying with one or more standards of
participation, without concluding that the provider's failure to
comply is so substantial as to constitute a failure to comply with
a condition of participation. In that event, HCFA is obligated,
under 42 C.F.R. 488.28, to give the provider an opportunity to
correct the deficiency. But, where HCFA determines that a failure
by a provider to comply with a standard or standards is so
substantial as to constitute a failure to comply with an overall
condition of participation, HCFA is not obligated to give that
provider the opportunity to correct the deficiency.
HCFA was not required by 42 C.F.R. 418.28 to give Petitioner an
opportunity to correct the deficiencies that were identified at the
May 6, 1994 resurvey. It is true, as Petitioner asserts, that the
surveyors who resurveyed Petitioner on May 6, 1994 found that
Petitioner failed to comply with standards of participation,
including a standard which was not cited in the report of
deficiencies generated after the initial survey on March 10, 1994.
However, the surveyors, and HCFA, concluded that Petitioner's
failure to comply with these standards was so substantial as to
constitute a failure to comply with conditions of participation.
C. Analysis of the parties' arguments and contentions
concerning Petitioner's compliance with conditions of participation
for hospices
HCFA asserts that, as of the May 6, 1994 resurvey of Petitioner,
Petitioner was not complying with four conditions of participation
in Medicare. These conditions are stated in 42 C.F.R. 418.50,
418.54, 418.58, and 418.68. I analyze HCFA's and Petitioner's
arguments and the evidence offered by the parties relevant to each
of these four conditions of participation pursuant to the elements
of HCFA's burden of persuasion that I have described at Part
II.B.1.b. of this decision.
1. Petitioner's alleged failure to comply with the
general provisions condition of participation stated in 42 C.F.R.
418.50
HCFA makes two arguments concerning Petitioner's alleged failure to
comply with the requirements of 42 C.F.R. 418.50. First, HCFA
asserts that the regulation states, as a condition of participation
in the hospice program, that hospices comply with conditions stated
elsewhere in 42 C.F.R. Part 418. HCFA avers that Petitioner failed
to comply with this asserted condition of participation because it
failed to comply with conditions of participation stated elsewhere.
Second, HCFA asserts that the regulation may be read, along with
other regulations, to establish as a condition of participation
that hospices provide laboratory services to their patients. HCFA
avers that Petitioner failed to comply with this asserted condition
because Petitioner did not provide laboratory services to a
patient.
I do not find that Petitioner failed to comply with the
requirements of 42 C.F.R. 418.50. Moreover, even if Petitioner
may have failed technically to comply with the requirements of this
regulation, the evidence does not establish the deficiency to be so
substantial as to prove that Petitioner failed to comply with a
condition of participation in Medicare.
I do not agree with HCFA's assertion that 42 C.F.R. 418.50
recites a condition of participation in Medicare that hospices
comply with conditions of participation stated elsewhere in the
regulations. This assertion relies on the language of 42 C.F.R.
418.50(a). That subsection states, as a standard of participation,
and not as a condition of participation, that "[a] hospice must
maintain compliance with the conditions of this subpart and
subparts D and E of . . . [42 C.F.R. Part 418]."
Contrary to HCFA's argument, 42 C.F.R. 418.50(a) does not say
that a failure by a hospice to comply with any condition of
participation in 42 C.F.R. Part 418 shall also be a failure to
comply with the condition of participation stated in 42 C.F.R.
418.50. It states, at most, that a failure to comply with a
condition of participation stated elsewhere in the regulations may
be construed to constitute a failure to comply with one of the
standards contained in 42 C.F.R. 418.50. HCFA has offered no
evidence to establish how a failure by a hospice to comply with
this standard, based on its failure to comply with a condition
stated elsewhere, would satisfy the test for a condition-level
deficiency contained in 42 C.F.R. 488.24.
More important, I am not persuaded by HCFA's argument because it
would lead to a result which is unnecessary and which the Secretary
did not intend. HCFA's argument is an attempt to turn every
failure by a hospice to meet a condition of participation into a
failure by that hospice to meet two conditions of participation.
I considered this argument in Lajas, and concluded there, as I do
here, that the Secretary did not intend that a hospice's failure to
comply with a condition of participation should be construed
automatically to constitute a failure to comply with two conditions
of participation. Lajas at 20 - 21.
A finding that a hospice manifests a condition-level deficiency
justifies termination of that hospice's participation in Medicare.
The finding that a hospice has failed to comply with a condition of
participation is a finding that the hospice cannot deliver care
consistent with the requirements of the Act and regulations or that
it is jeopardizing the health and safety of its patients. It is
wholly unnecessary to make a condition-level deficiency appear more
egregious than it actually is by tacking on automatically to each
finding of a condition-level deficiency a finding of a second
condition-level deficiency.
HCFA bases its second argument that Petitioner failed to comply
with the condition of participation stated in 42 C.F.R. 418.50
on the findings of the surveyor who performed the May 6, 1994
resurvey and its assertion that the participation requirements for
hospices required Petitioner to provide laboratory services to its
patients. In this instance, the facts are not contested. However,
HCFA's assertion that the conditions for participation of hospices
in Medicare include a requirement that hospices provide laboratory
services to their patients is not supported either by the plain
meaning of the regulations or by a reasonable interpretation of
those regulations. Moreover, even if I were to find that this
asserted obligation is implied in the regulations, there is no
evidence in this case that HCFA ever communicated it to Petitioner.
At the May 6, 1994 resurvey of Petitioner, HCFA's surveyor selected
at random 10 patient records for review. These records included
the patient records of an individual known for purposes of this
case as patient # 2. HCFA Ex. 21. The records of patient # 2
establish that, on March 18, 1994, a physician ordered that a blood
test be administered to the patient. Id. at 3 - 4. The nurse who
performed the test gave the specimen to the patient's family. She
instructed the family to take the specimen to a laboratory, and to
provide the hospice with the test results that the laboratory
reported. Tr. at 86. The surveyor who conducted the May 6, 1994
resurvey learned from Petitioner's staff that, as of the date that
the blood test was performed on patient # 2, Petitioner did not
have an agreement with a laboratory to provide laboratory services
for Petitioner's patients. Id. at 86 - 87.
HCFA argues that hospice participation requirements include the
requirement that hospices provide laboratory services to their
patients. HCFA argues that Petitioner's failure either to provide
laboratory services on its own, or to have an agreement with a
laboratory to provide such services, is a failure to comply with
this requirement. HCFA asserts that the alleged requirement that
hospices provide laboratory services to their patients is either
stated or implied in the regulations which govern hospices and is
incorporated by reference into 42 C.F.R. 418.50(b)(2) and (3),
either as an "other covered service," as a "reasonable and
necessary service," or as a service that is consistent with
"accepted standards of practice."
The general provisions regulation states, at 42 C.F.R.
418.50(b), that a hospice must be primarily engaged in providing
the care and services described at 42 C.F.R. 418.202.
Additionally, it states that a hospice must:
(1) [m]ake nursing services, physician services, and drugs and
biologicals routinely available on a 24-hour basis;
(2) [m]ake all other covered services available on a 24-hour
basis to the extent necessary to meet the needs of individuals for
care that is reasonable and necessary for the palliation and
management of terminal illness and related conditions; and
(3) [p]rovide these services in a manner consistent with
accepted standards of practice.
42 C.F.R. 418.50(b)(1) - (3).
Laboratory services are not among the services listed in 42 C.F.R.
418.202. HCFA argues that the obligation to provide laboratory
services may be found in 42 C.F.R. 418.92(b). From this, HCFA
asserts that laboratory services are among the "other covered
services" described in 42 C.F.R. 418.50(b)(2) that hospices are
obligated to provide to their patients.
HCFA argues also that laboratory services are "reasonable and
necessary for the palliation and management of terminal illness and
related conditions." From this, HCFA asserts that the obligation
of a hospice to provide laboratory services to its patients is
implied in 42 C.F.R. 418.50(b)(2).
Finally, HCFA asserts that "accepted standards of practice" for
hospices includes providing laboratory services. HCFA asserts that
the requirement that a hospice provide laboratory services to its
patients is therefore implied by 42 C.F.R. 418.50(b)(3).
None of these arguments relate reasonably to the language of the
regulations. For that reason, I find them to be without merit.
Neither the Act nor regulations support HCFA's contention that the
"other covered services" that a hospice must provide include
laboratory services. There is no explicit requirement in the Act
or in the regulations that hospices provide laboratory services to
their patients. As HCFA concedes, the Act says nothing about an
obligation to provide laboratory services. Furthermore, there is
not even an implied obligation in the regulations for a hospice to
provide laboratory services to its patients.
First, I do not read 42 C.F.R. 418.50 as requiring hospices to
provide services to their patients beyond those that are listed as
"covered services" in 42 C.F.R. 418.202. The covered services
described in 42 C.F.R. 418.202 are a complete list of services
that a participating hospice is required to provide to its patients
and to members of patients' families. The phrase "other covered
services" in 42 C.F.R. 418.50(b)(2) does not refer to services
in addition to those which are described in 42 C.F.R. 418.202.
It refers only to the manner in which a hospice must provide those
services which are described in 42 C.F.R. 418.202 and which are
not enumerated in 42 C.F.R. 418.50(b)(1). Thus, "other covered
services" means services not listed in 42 C.F.R. 418.50(b)(1)
that are listed in 42 C.F.R. 418.202.
Moreover, even if 42 C.F.R. 418.202 did not comprise a complete
list of the services that hospices are obligated to provide, there
is no requirement stated elsewhere in the regulations that hospices
provide laboratory services. The regulation which HCFA relies on
as allegedly directing hospices to provide laboratory services as
other covered services, 42 C.F.R. 418.92, cannot be construed
reasonably to require hospices to provide laboratory services.
That regulation governs only the manner in which a hospice must
provide laboratory services if it chooses to provide them. It
contains two relevant subparts. 42 C.F.R. 418.92(b)(1) states
that:
[i]f the hospice engages in laboratory testing outside of the
context of assisting an individual in self-administering a test .
. ., such testing must be in compliance with all applicable
requirements of part 493 of this chapter.
The other relevant subpart, 42 C.F.R. 418.92(b)(2), states that:
[i]f the hospice chooses to refer specimens for laboratory
testing to another laboratory, the referral laboratory must be
certified . . . in accordance with the applicable requirements of
part 493 of this chapter.
Neither of these subparts require a hospice to provide laboratory
services. They may be read reasonably only to impose requirements
on hospices to assure that tests are performed consistent with the
requirements of 42 C.F.R. Part 493, to the extent that hospices
elect to perform the tests or to refer them elsewhere.
I make no finding as to whether HCFA is correct in its assertion
that laboratory services are reasonable and necessary for the
palliation and management of terminal illnesses and related
illnesses. I do not, because such services are not covered
services. It may be reasonable or even good medical practice for
hospices to provide laboratory services to patients. However, the
issue is not whether hospices ought to provide laboratory services
but whether, under the regulations governing their participation in
Medicare, they are required to provide such services.
HCFA reads 42 C.F.R. 418.50(b)(3) as requiring hospices to
provide to their patients all services that are generally accepted
by the hospice community as being within that community's standards
of practice. That is not what the regulation requires. The term
"these services" in 42 C.F.R. 418.50(b)(3) can be construed
reasonably to mean only those services described elsewhere in the
regulations which govern hospices as covered services that hospices
are obligated to provide to their patients. The subsection
requires that covered services be provided in a manner that is
consistent with accepted standards of practice. It does not impose
on hospices any obligation to provide services in addition to those
services described elsewhere in the regulations as covered
services. For the reasons which I discuss above, laboratory
services are not covered services.
I would not find Petitioner to have failed to comply with a
requirement that it provide laboratory services to its patients
even if I were to conclude, as HCFA urges, that the requirement is
implied in the regulations. It would not be reasonable to find
that a hospice should infer from the regulations that it is
required to provide laboratory services. The regulations do not
mention this requirement. HCFA has offered no evidence to show
that it ever communicated to Petitioner its conclusion that the
regulations contain an implied requirement that hospices provide
laboratory services.
2. Petitioner's alleged failure to comply with the
medical director condition of participation stated in 42 C.F.R.
418.54
HCFA argues that Petitioner failed to comply with the condition of
participation stated in 42 C.F.R. 418.54. This regulation
describes the duties of a hospice's medical director. It states
that:
[t]he medical director must be a hospice employee who is a
doctor of medicine or osteopathy who assumes overall responsibility
for the medical component of the hospice's patient care program.
The regulation does not define the terms "overall responsibility"
or "medical component." However, these terms are not ambiguous.
The plain meaning of this regulation is that the medical director
of a hospice must assume supervisory and management responsibility
for the medical services that the hospice provides to its patients.
HCFA asserts that Petitioner failed to comply with the requirements
of this regulation in two respects. First, HCFA argues that
Petitioner's medical director failed to discharge his
responsibility to assure that Petitioner's interdisciplinary group
participated in the planning of patient care as is required under
the regulations. Second, HCFA asserts that Petitioner's medical
director failed to assure that Petitioner obtain properly executed
certifications of terminal illness for its patients.
Petitioner did not comply with the medical director requirement in
42 C.F.R. 418.54. Petitioner's medical director was obligated,
as part of the responsibility to manage the medical component of
Petitioner's operations, to assure that Petitioner's
interdisciplinary group participated in the planning of patient
care as is required by the regulations. Petitioner's medical
director bore responsibility for assuring that Petitioner obtained
a properly executed certification of terminal illness for each of
Petitioner's patients. The preponderance of the evidence
establishes that Petitioner's medical director failed to perform
these obligations.
HCFA bases its arguments on the following evidence.
The surveyor who conducted the May 6, 1994 resurvey
of Petitioner testified that in none of the 10 treatment records
that she reviewed was there evidence that Petitioner's
interdisciplinary group periodically reviewed the patient's plan of
care according to a schedule established in the plan of care. Tr.
at 98 - 99.
The surveyor testified also that in none of the
patient records she reviewed was there evidence that Petitioner had
obtained certifications that the patients were eligible for
continued hospice care after their initial period of care. Id. at
98.
I find this evidence to be persuasive.
Petitioner did not rebut credibly HCFA's evidence as to failure of
Petitioner's interdisciplinary group to perform regularly scheduled
reviews of plans of care. Petitioner offered the testimony of Dr.
Dimas Broco Hernandez, Petitioner's medical director. Tr. at 218
- 22. Dr. Broco Hernandez testified that Petitioner's
interdisciplinary group would meet weekly to discuss patients'
cases. Tr. 219 - 20. Dr. Broco Hernandez asserted that the
hospice staff was supposed to have made a written record of the
weekly meetings. However, Petitioner did not offer any written
evidence of such alleged weekly reviews to corroborate Dr. Broco
Hernandez' testimony. Moreover, Petitioner did not offer any
documents from the records of the 10 patients reviewed by the
surveyor to impeach her testimony.
It is apparent from the scheme of hospice operations envisioned by
the regulations that a hospice's medical director bears
responsibility for assuring that the hospice's interdisciplinary
group discharge its functions properly. While the regulations do
not charge the medical director explicitly with supervising the
activities of the interdisciplinary group, the regulations do
require the medical director to supervise the entire medical
component of hospice operations. 42 C.F.R. 418.54. This
responsibility includes supervision of the activities of the
interdisciplinary group, inasmuch as the interdisciplinary group is
central to the medical component of a hospice's services.
The planning and management of patient care through the development
and revision of plans of care is an essential element of the
medical component of hospice operations. 42 C.F.R. 418.58. A
hospice's interdisciplinary group plays a critical role in the
planning of care to be administered by a hospice to its patients.
The interdisciplinary group bears direct responsibility, along with
the medical director of the hospice, for creation of and review of
plans of care. Id.; 42 C.F.R. 418.68. The interdisciplinary
group is thus a central player in the administration of the medical
component of a hospice's operations. It is the explicit duty of
the medical director to participate in the establishment of and
review of plans of care. 42 C.F.R. 418.58(a), (b). 9/
I conclude also that Petitioner's medical director was responsible
for assuring that Petitioner obtain properly executed
certifications of terminal illness for each of Petitioner's
patients. The preponderance of the evidence in this case is that
Petitioner failed systematically to obtain properly executed
certifications for its patients. The systematic failure to obtain
properly executed certifications is a failure to perform the
supervisory responsibilities described in 42 C.F.R. 418.54.
A hospice's medical director bears responsibility for supervising
the certification of patients to receive hospice care. Consistent
with requirements in the Act, the regulations which govern hospices
require that patients who receive care from hospices be certified
as having a terminal illness. 42 C.F.R. 418.20, 418.22. The
regulations make it the responsibility of the hospice to obtain
these certifications. 42 C.F.R. 418.22. Certifications must be
obtained at intervals specified in the regulations. 42 C.F.R.
418.21, 418.22(a). Each certification of terminal illness must
specify that the patient's prognosis is for a life expectancy of
six months or less if the patient's illness runs its normal course.
42 C.F.R. 418.22(b).
The regulations specify that initial and subsequent certifications
of a patient's terminal illness must be signed by the hospice's
medical director or by a member of the interdisciplinary group. 42
C.F.R. 418.22(c)(1)(i), (2).
This requirement makes it plain that certification of patients as
being eligible to receive hospice care is a part of the medical
component of hospice operations, even as is the administration of
care to hospice patients. A hospice's medical director is
responsible for assuring that certifications are made in compliance
with the Act and regulations as part of his or her responsibility
for supervising the medical component of hospice operations.
Petitioner argues that failure by a hospice to obtain properly
executed certifications of eligibility for hospice care for its
patients relates only to the question of whether the hospice should
receive reimbursement from Medicare for its services. Petitioner
asserts that there is no requirement in the conditions of
participation that a hospice obtain properly executed
certifications of eligibility. Therefore, according to Petitioner,
it cannot be held accountable under the medical director condition
of participation for failure to obtain properly executed
certifications.
I do not agree with this argument. It is true, as Petitioner
asserts, that the regulations governing patient certifications are
in a different subpart of 42 C.F.R. Part 418 than are the
conditions of participation. The certification regulations are in
Subpart B of Part 418, whereas the conditions of participation are
in Subparts C, D, and E of Part 418. However, that does not
suggest that certifications are outside of the medical component of
hospice operations. I conclude that obtaining certifications of
terminal illness for patients is a part of the medical component of
a hospice's operations. The certification is based on a medical
diagnosis. It is the document which authorizes a hospice to assume
responsibility for a patient's care and to provide palliative, as
opposed to curative, care.
The regulations do not state, as a condition of participation, that
hospices obtain properly executed certifications. However,
inasmuch as certifications fall within the medical component of
hospice operations, the regulations must be read as requiring that
a hospice medical director assure that properly executed
certifications be obtained.
There remains the question of the impact of the failure of
Petitioner's medical director to discharge the supervisory
responsibilities required by the regulation. I conclude that the
failures in this case are so substantial as to establish a failure
to comply with the condition of participation described in 42
C.F.R. 418.54.
The requirement that a hospice's interdisciplinary group actively
participate in the planning of patients' care is a central element
in the scheme of operations to which the regulations require
hospices to adhere. It is manifest from the regulations that a
hospice cannot provide care adequately to its patients unless its
interdisciplinary group assumes the required role in planning and
monitoring patient care. So also is it evident from the
regulations that a hospice cannot provide care adequately to its
patients unless it assures that these patients are indeed
terminally ill. The purpose of hospice care is palliative. The
providing of palliative care to a patient on the assumption that
the patient is terminally ill, without the requisite certification
of terminal illness, may jeopardize that patient's health and
safety, because if the patient is not, in fact, terminally ill, he
or she may require more aggressive medical treatment than the
hospice is in a position to provide.
3. Petitioner's alleged failure to comply with the plan
of care condition stated in 42 C.F.R. 418.58
HCFA argues that Petitioner failed to comply with the condition
stated in 42 C.F.R. 418.58. This regulation governs the plans
of care that hospices are obligated to create and review for each
of their patients. 10/ The regulation requires a hospice to
establish and maintain a written plan of care for each of its
patients. It requires also that care provided to each hospice
patient must be in accordance with a plan of care.
The regulation contains three subparts which enunciate standards
that a hospice must adhere to in establishing and reviewing its
plans of care. For each patient, a plan of care must be
established by the patient's attending physician, the hospice's
medical director or physician designee, and the hospice's
interdisciplinary group, prior to providing care to that patient.
42 C.F.R. 418.58(a). Each plan of care must be reviewed and
updated at intervals specified in the plan by the patient's
attending physician, the hospice's medical director or physician
designee, and the hospice's interdisciplinary group. 42 C.F.R.
418.58(b). All reviews must be documented. Id. Each plan of care
must include an assessment of the patient's needs and must identify
the services to be provided to the patient, including the
management of discomfort and symptom relief. 42 C.F.R.
418.58(c). Each plan of care must state in detail the scope and
frequency of services needed to meet the patient's needs, as well
as those of the patient's family. Id.
HCFA's central assertion concerning Petitioner's alleged
noncompliance with the plan of care regulation is that Petitioner's
interdisciplinary group failed to conduct the reviews mandated
under 42 C.F.R. 418.58(b). HCFA asserts also that, in one
instance, Petitioner failed to meet the needs of a patient's family
as is required under 42 C.F.R. 418.58(c).
The evidence which HCFA relies on to support these assertions
consists of excerpts of the medical records of four patients
(patients # 2, # 5, # 6, and # 7), as well as the testimony of the
surveyor who conducted the May 6, 1994 resurvey of Petitioner. The
evidence establishes that, for all of these patients, extensive
periods of time elapsed without documented reviews of the patient's
plan of care by Petitioner's interdisciplinary group.
The essentially unrefuted evidence is that Petitioner's
interdisciplinary group had not reviewed the plan of care for
patient # 2 between June 18, 1993 and May 6, 1994, the date of the
resurvey. Tr. at 119. The interdisciplinary group had not
reviewed the plan of care for patient # 6 in the five months that
preceded the resurvey. Tr. at 126. The plan of care for patient
# 7 had not been reviewed in the three months that preceded the
resurvey. Tr. at 125.
Furthermore, the weight of the evidence is that Petitioner did not
establish schedules pursuant to which plans of care were supposed
to be reviewed. Neither the records of patient # 6 or # 7 stated
a schedule for reviewing the plans of care for these patients.
HCFA Exs. 23, 24.
The only evidence which Petitioner offered to counter this evidence
was the testimony of Dr. Broco Hernandez. However, his testimony
that Petitioner's interdisciplinary group met weekly to discuss
plans of care is not corroborated by any documentation. See Tr. at
219 - 20. Indeed, it is undercut substantially by the evidence
that HCFA obtained which shows that plans of care were not reviewed
according to any cognizable schedule.
Petitioner argues that HCFA's allegation of noncompliance with the
provisions of 42 C.F.R. 418.58(b) is based on an incorrect
interpretation of the regulation. HCFA, according to Petitioner,
is misreading this subsection to require plans of care to state the
dates when reviews will be conducted. This requirement is not
found in the regulation, according to Petitioner.
I am not persuaded by this argument. The provider made the same
argument in Lajas. The regulation requires a hospice to conduct
reviews of each of its plans of care "at intervals specified in the
plan . . . ." 42 C.F.R. 418.58(b). I read this requirement to
give the hospice the option to establish a review schedule based
either on the calendar or on some event specified in the plan of
care such as a change in the patient's condition. Lajas at 11.
However, what the evidence establishes in this case is that
Petitioner's plans of care were not reviewed according to any
cognizable schedule. The deficiency is Petitioner's failure to
conduct regular reviews of its plans of care and to document
reviews.
The preponderance of the evidence in this case proves that
Petitioner was neither scheduling periodic reviews of the plans of
care for its patients, nor was it reviewing the plans according to
a schedule. The evidence establishes further that, if Petitioner
was conducting any scheduled reviews of plans of care, it was not
documenting those reviews. These failures by Petitioner are
failures to comply with the explicit requirements of 42 C.F.R.
418.58(b).
I do not find that Petitioner failed to comply with the
requirements of 42 C.F.R. 418.58(c). HCFA bases its assertion
that Petitioner did not comply with this subsection on unrefuted
evidence that Petitioner failed to establish a bereavement plan of
care to deal with the death of patient # 5. Tr. at 122. HCFA's
assertion that Petitioner failed to comply with this subsection
rests ultimately on an interpretation of the subsection to require
a hospice to create a new or revised plan of care to address any
change in a patient's condition. HCFA made that same argument in
Arecibo. I concluded that this requirement, while not necessarily
unreasonable, was not apparent from the face of the subsection.
Arecibo at 22 - 25. I found that HCFA had not communicated this
interpretation to the provider. I reach that same conclusion and
finding here.
The failure of Petitioner's interdisciplinary group to conduct
reviews of Petitioner's plans of care and to document those reviews
is so substantial as to constitute a violation of the condition of
participation stated in 42 C.F.R. 418.58. In Arecibo and
Lajas, I held that the requirement that plans of care be reviewed
periodically by a hospice's interdisciplinary group and that these
reviews be documented is fundamental to the appropriate discharge
of a hospice's treatment obligations to its patients. Arecibo at
25 - 26; Lajas at 19 - 20.
A hospice cannot meet its critical responsibility to manage the
care it provides to its dying patients to maximize the patients'
physical comfort and to relieve the patients and their families of
the emotional stress caused by the patients' death without planning
the patients' care and without systematically reviewing that care.
Lajas at 20. Petitioner's failure to perform this essential
function substantially limited its capacity to render adequate
care. Furthermore, its failure had the potential to adversely
affect the health and safety of Petitioner's patients.
4. Petitioner's alleged failure to comply with the
interdisciplinary group condition of participation stated in 42
C.F.R. 418.68
HCFA argues that Petitioner failed to comply with the condition of
participation stated in 42 C.F.R. 418.68. This regulation
establishes the condition that a hospice create an
interdisciplinary group or groups to manage the care of its
patients. It requires that the interdisciplinary group participate
in the establishment of each plan of care that a hospice prepares
for a patient. 42 C.F.R. 418.68(b)(1). It requires also that
the interdisciplinary group participate in the periodic review and
updating of each plan of care. 42 C.F.R. 418.68(b)(3). These
requirements thus mirror the requirement contained in 42 C.F.R.
418.58 that a hospice's interdisciplinary group participate in the
creation and revision of each patient's plan of care.
HCFA asserts that Petitioner's interdisciplinary group failed
generally to participate in the review of plans of care. It
supports this assertion with the same evidence it offered to show
that plans of care were not being reviewed by Petitioner's
interdisciplinary group in accordance with the requirements of 42
C.F.R. 418.58. I discussed that evidence in the preceding
section of this decision. For reasons that I have stated, I find
it to be persuasive.
HCFA argues also that, with respect to patient # 8, there was a
failure by Petitioner's interdisciplinary group to participate in
the planning of the patient's care. That assertion is based on the
fact that, while the patient was listed by Petitioner as one of its
patients, the patient was being cared for by another hospice.
Petitioner asserts that this de facto transfer of the patient was
due to the remote location of Utuado and the difficulties that
Petitioner experienced in attending to the patient's needs. It is
unnecessary for me to make findings as to patient # 8 to resolve
any of the issues in this case, and I do not.
The failure of Petitioner's interdisciplinary group to participate
in the planning of care and in reviews of plans of care is a
failure of the condition of participation stated in 42 C.F.R.
418.68. The regulation makes it plain that the obligation to plan
care is a critical element of the interdisciplinary group's duties.
It reinforces the requirements of the plan of care regulation. As
I find above, it is not possible for a hospice to discharge its
obligations to its patients consistent with the requirements of law
if it does not utilize its interdisciplinary group in the manner
required by the regulations.
III. Conclusion
HCFA proved by a preponderance of the evidence that, as of May 6,
1994, Petitioner was not complying with three conditions of
participation stated in 42 C.F.R. Part 418. These conditions are:
medical director (42 C.F.R 418.54); plan of care (42 C.F.R.
418.58); and interdisciplinary group (42 C.F.R. 418.68).
Essentially, HCFA proved that Petitioner was derelict in its
responsibility to manage and care for the needs of its patients in
a way that jeopardized Petitioner's capacity to render adequate
care and which had the potential to affect adversely the health and
safety of Petitioner's patients. Based on this, HCFA had the
authority to terminate Petitioner's participation in Medicare.
_______________________
Steven T. Kessel
Administrative Law Judge
1. In this decision, I refer to specific excerpts from the
transcript of the hearing as "Tr. at (page)."
2. Under the Medicare program, an individual is considered to
be "terminally ill" if that individual has a medical prognosis that
he or she is expected to live six months or less. Act, section
1861(dd)(3)(A).
3. HCFA now asserts that, in its original notice to Petitioner,
it advised Petitioner that it was not complying with eleven
conditions of participation in Medicare. The additional conditions
of participation which HCFA found Petitioner not to be complying
with are found at 42 C.F.R. 418.56 (professional management);
418.68 (interdisciplinary group); 418.74 (central clinical
records); and 418.88 (counseling services). HCFA concedes that the
March 23, 1994 notification to Petitioner did not mention these
four additional conditions. However, the statement of deficiencies
which was prepared after the March 10 survey, and which was
transmitted to Petitioner along with the March 23, 1994 notice, did
cite these additional conditions. HCFA Ex. 15 at 10 - 12, 19 - 30,
34 - 35. I make no findings in this decision as to whether the
notice which HCFA sent to Petitioner on March 23, 1994 adequately
notified Petitioner of the additional deficiencies found by HCFA.
My reason for not doing so is that the findings made by HCFA based
on the May 6, 1994 resurvey of Petitioner supersede those made at
the initial survey of March 10, 1994.
4. This case does not involve the issue of whether, at the
resurvey of Petitioner, HCFA would be required to evaluate
Petitioner's compliance based on what Petitioner had promised in
its plan of correction. That is so because HCFA never accepted the
plan of correction. However, had HCFA accepted the plan of
correction, then I would have had to decide whether the terms of
the plan became the operative criteria for assessing whether
Petitioner was complying with the conditions of participation
addressed in the plan. And, had I found that the terms of the plan
became the operative criteria, then I would have had to evaluate
the evidence in this case on the basis of whether it proved that
Petitioner was not complying with the terms of the plan of
correction.
5. As in this case, Arecibo and Lajas involved the propriety of
terminations by HCFA of hospices' participation in the Medicare
program. The same attorney represented the petitioners in Arecibo,
Lajas, and the present case. The briefs which HCFA and the
petitioners submitted in Arecibo, Lajas, and this case make the
same arguments as to the legal issues which are common to the three
cases.
6. In this decision, I use the term "burden of persuasion" to
refer collectively to the burdens of coming forward with evidence
of a fact and of proving that fact by a preponderance of the
evidence.
7. I do not read the regulation as qualifying all surveyors as
expert witnesses. The regulation establishes the criteria for
surveyors' performance. In a hearing concerning a survey, HCFA may
qualify a surveyor to be an expert witness. A provider may
challenge a surveyor's qualifications to testify as an expert
witness. HCFA bears the burden of proving that any purported
expert has the qualifications to testify as an expert witness.
8. The standard is set forth at 42 C.F.R. 418.58(b) and is
part of the condition governing plans of care that hospices create
and maintain for their patients.
9. This regulation provides that plans of care must be
established and reviewed by, among others, the medical director or
"physician designee." The regulation does not define of whom a
"physician designee" consists. Apparently, however, the physician
designee would be an individual who is designated by the hospice to
serve in lieu of the medical director in establishing and reviewing
plans of care. Petitioner has not argued that it appointed a
physician designee to serve in lieu of its medical director.
10. The central issue in the Arecibo and Lajas cases was
whether the providers in those cases complied with the plan of care
regulation. I discussed the requirements of the plan of care
regulation in both cases. Arecibo at 13 - 16, 19 - 25; Lajas at 16
- 19.