Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
|
IN THE CASE OF | |
Wells House, |
DATE: November 13, 2000 |
- v - |
|
Health Care Financing Administration |
Docket No.C-98-554 Decision No. CR714 |
DECISION | |
I decide that the Health Care Financing Administration
(HCFA) correctly determined to certify Petitioner, Wells House, to participate
in the Medicare program, effective April 14, 1998. I. Background By letter dated May 4, 1998, HCFA certified Petitioner
to participate as a provider in the Medicare program, effective April
14, 1998. Petitioner disagreed with HCFA's determination by contending
that Medicare certification should have been granted at an earlier date
and requested a hearing. This case was assigned to Administrative Law
Judge (ALJ) Edward Steinman. Subsequently, this case was reassigned to
ALJ Cynthia Josserand and then to me. HCFA submitted a motion for summary judgment with six
accompanying exhibits, marked exhibits A - F. I have remarked HCFA's exhibits
as exhibits 1 - 6, to comply with Civil Remedies Division procedures.
Petitioner submitted a motion for summary judgment accompanied by two
declarations and five exhibits, marked as exhibits 1 - 5. Petitioner's
reply brief was accompanied by three additional exhibits, marked as exhibits
6 - 8. Neither party objected to any of the exhibits submitted. I admit
into evidence HCFA Exhibits (HCFA Exs.) 1 - 6 and Petitioner Exhibits
(P. Exs.) 1 - 8. I base my decision in this case on the law and the parties'
submissions. II. Applicable law and regulations The regulations require that an entity, such as a hospice,
must apply to HCFA to be certified to participate in Medicare. 42 C.F.R.
� 489.10(a). In order to be certified, an applicant must first be surveyed
to ascertain whether the applicant meets all conditions of participation.
42 C.F.R. � 489.10(a). HCFA has delegated to the individual State survey
agencies the authority to conduct surveys on HCFA's behalf. After the
requisite surveys have been completed, the State survey agency forwards
a recommendation to HCFA concerning the applicant's compliance with the
federal requirements. 42 C.F.R. � 488.11. HCFA then
makes an independent determination to either grant or deny the application
for Medicare certification. HCFA will accept an applicant's participation
agreement on the date that a survey of that applicant is completed, provided
that the applicant meets all of the pertinent federal requirements on
that date. 42 C.F.R. � 489.13. The regulations do
not permit HCFA to certify a provider to participate in Medicare on a
date that is earlier than the date of the completion of the certification
survey. 42 C.F.R. � 489.13(b), (c). If an applicant for participation fails to satisfy all
federal requirements as of the date of completion of the survey, then
HCFA will not certify that applicant to participate in Medicare until
HCFA is satisfied that the applicant meets the federal requirements. Id.
If HCFA finds, on the basis of a survey, that an applicant (other than
a skilled nursing facility) complies with all conditions of participation,
but has a lower level deficiency or deficiencies, then HCFA will certify
the applicant to participate on the earlier of the following dates: the
date that the applicant actually complies with all federal requirements;
or, the date on which HCFA or the State survey agency receives from the
applicant a plan of correction which addresses the outstanding deficiencies
and which HCFA accepts. Id. The regulations which define the Secretary's requirements
for Medicare participation for a hospice program establishes conditions
of participation for those hospice programs. These conditions of participation,
which must be met by a hospice program, are set forth in the statute at
section 1861(dd) of the Social Security Act (Act) and are implemented
in the regulations at 42 C.F.R. Part 418. The regulations express these
conditions of participation as broadly stated criteria. The regulations
also state standards of participation as subsidiary components of the
conditions of participation. In determining whether there has been compliance
with a particular condition of participation, a State survey agency evaluates
the manner and degree of the provider's compliance with the various standards
within each condition. 42 C.F.R. � 488.26(b). III. Issue, Findings of Fact, and conclusions
of Law
The issue in this case is whether HCFA correctly determined
to certify Petitioner to participate in Medicare, effective April 14,
1998.
I make the following findings of fact and conclusions
of law to support my decision that HCFA correctly determined to certify
Petitioner in Medicare, effective April 14, 1998.
IV. Discussion Petitioner operates a hospice program in Long Beach, California.
Petitioner applied for a State license as a hospice on February 21, 1997.
Petitioner was surveyed for the State license on August 12, 1997. The
State licensing survey resulted in a finding of deficiencies which were
later corrected. Petitioner received a Congregate Living Health Facility-B
(CLHF) license, effective September 26, 1997. An initial Medicare certification survey was completed
on December 10, 1997 by the California State survey agency. By letter
dated January 15, 1998, HCFA notified Petitioner that the certification
survey found that Petitioner was not in compliance with seven conditions
of participation and, as a result, Petitioner's application to participate
in the Medicare program was denied. HCFA Ex. 1. The notice letter cited
42 C.F.R. � 489.10(a) as requiring that a provider meet the necessary
conditions of participation in order to be accepted into participation
with the Medicare program. Id. The denial was not appealed by Petitioner.
Rather, Petitioner submitted a plan of correction on February 18, 1998. On February 20, 1998, Petitioner submitted a second application
and request for certification to participate as a hospice provider in
the Medicare program. HCFA Ex. 2. A second certification survey was completed
on April 14, 1998. The second survey found that Petitioner was in compliance
with all conditions of participation specified at 42 C.F.R. Part 418.
By letter dated May 4, 1998, HCFA notified Petitioner that HCFA had approved
Petitioner's request to participate in Medicare as a hospice provider,
effective April 14, 1998. HCFA Ex. 4. Petitioner requested reconsideration
of HCFA's determination by contending that Medicare certification should
have been granted at an earlier date. By letter dated June 17, 1998, HCFA
notified Petitioner that it could not grant Petitioner's request for an
earlier effective date. HCFA Ex. 6. Subsequently, Petitioner requested
a hearing. It is HCFA's responsibility to determine whether an applicant
for participation in the Medicare program as a provider meets the applicable
conditions of participation for certification as a provider. 42 C.F.R.
� 488.12; see, e.g., Arbor Hospital of Greater Indianapolis,
DAB No. 1591, at 7 n.6 (1996); Central Suffolk Hospital v. Shalala,
841 F. Supp. 492, 495 (E.D.N.Y. 1994). Until there is a finding of full
compliance made by HCFA, HCFA is not authorized to certify the applicant.
Governing regulations provide that the earliest date on which HCFA has
authority to certify a provider to participate in Medicare is the date
of the completion of the Medicare certification survey by the State agency
that finds the provider in compliance with all conditions of participation.
42 C.F.R. � 489.13. The date of the survey that found Petitioner to be in
compliance with conditions of participation was April 14, 1998. The earliest
date on which HCFA had authority to certify Petitioner is April 14, 1998.
The Medicare participation agreement was made effective on the earliest
day permissible, April 14, 1998. Until there is an onsite certification
survey that has been completed and "there is a finding of full compliance
[with Medicare conditions of participation] by HCFA, HCFA does not have
the authority to issue a provider number." Arbor Hospital, DAB
No. 1591; accord Suffolk Hospital v. Shalala, 841 F. Supp.
492. The regulations state that the initial effective date
of certification of a provider agreement is the earlier of:
42 C.F.R. � 489.13(c)(2)(i), (ii). Petitioner's basis
for its motion for summary judgment is that the effective date for Medicare
certification should be found when Petitioner was in substantial compliance
with lower levels of deficiencies and not when Petitioner was in complete
compliance. P. Br., at 1. Petitioner argues that, under 42 C.F.R. �
489.13(c)(2)(ii), it filed a plan of correction on February 18, 1998,
following the December 10, 1997 survey and that, based on that plan of
correction, HCFA should have granted Petitioner certification, effective
February 18, 1998. Section 489.13(c)(2)(ii) of the regulations has two elements
that must both be met. First, the provider must have been found to meet
all the conditions of participation; second, the provider must have only
low level deficiencies that can be cured by an acceptable plan of correction.
In this case, Petitioner had met neither element prior to April 14, 1998. It is clear that Petitioner had not met the first element
because HCFA's notice letter of January 15, 1998, determined that Petitioner
was not in compliance with seven conditions of participation applicable
to hospice programs and Petitioner failed to appeal this notice letter.
HCFA Ex. 1. Petitioner cannot now challenge this determination, because
any such challenge would be untimely. A request for hearing to challenge
this determination would have to have been filed no later that March 21,
1998, 60 days from the presumed date of receipt by Petitioner. 42 C.F.R.
� 498.40(a)(2). It is also clear that Petitioner had not met the second
element of section 489.13(c)(2)(ii). Petitioner
was not in compliance with seven conditions of participation. The regulations
express these conditions of participation as broadly stated criteria.
Each condition of participation is made up of a number of related standards
of participation. Each standard of participation, taken individually,
could be a basis of a deficiency. Therefore, failing to be in compliance
with even one condition is a failure in a broad area. Petitioner concedes
that the term "low level deficiencies" is not defined in the regulations.
P. Br., at 8. Petitioner suggests that low level deficiencies must be
something less than immediate jeopardy. P. Br., at 8 n.9. I find that
Petitioner's suggestion is unsupportable. A low level deficiency must
be something relatively minor that can be cured by submitting an acceptable
plan of correction. A finding that a provider broadly fails to meet requirements
such that it is out of compliance with a condition of participation cannot
be characterized as a low level deficiency. The requirement for a hospice to participate in Medicare
is that it meet the conditions of participation. 42 C.F.R. � 489.10(a).
The December 10, 1997 survey disclosed that Petitioner was not complying
with conditions of participation directly relating to patient care. For
example, Petitioner: (1) lacked a medical director with overall responsibility
for the medical component of the hospice's patient care program, in violation
of 42 C.F.R. � 418.54; (2) failed to ensure the continuity of outpatient
care, in violation of 42 C.F.R. � 418.56; (3) failed to establish and
maintain an individualized written plan of care for each patient, in violation
of 42 C.F.R. � 418.58; (4) failed to provide written instructions for
patient care, in violation of 42 C.F.R. � 418.68; and (5) failed to ensure
that drugs and biologicals were provided as needed for the palliation
and management of terminal illness and related conditions, in violation
of 42 C.F.R. � 418.80. These are non-compliances of a serious and systemic
nature that directly impact on patient care and cannot be considered low
level deficiencies. Whatever the precise meaning of "low level deficiencies"
may be, it is evident that failure of even one condition of participation,
let alone seven such areas, cannot be what is meant by "low level deficiencies"
as stated in 42 C.F.R. � 489.13(c)(2)(ii). As support for its position, Petitioner relies on statements
by Petitioner's owner, Ronald Morgan, and a hired consultant, Susan McGloghlon,
both of whom maintain that the Statement of Deficiencies, evidencing Petitioner's
failure to meet seven conditions of participation following the December
survey, reflects only "lower level deficiencies." Mr. Morgan states only that he "considered the deficiencies
[cited on the Statement of Deficiencies] to be lower level." P. Br., at
16. Mr. Morgan's opinion, however, is not supported by any reasons. If
Mr. Morgan is disagreeing with the factual findings expressed in the Statement
of Deficiencies, then he has waited too long to pursue this argument.
The time to challenge the facts upon which the Statement of Deficiencies
was based was within 60 days following receipt of HCFA's January 15, 1998
notice letter. Mr. Morgan cannot now contest that the findings in the
Statement of Deficiencies, if accurate, constitute non-compliance with
seven conditions of participation. In fact, when Petitioner submitted
a plan of correction after the December survey, the plan of correction
reflected profound systemic changes. These profound systemic changes indicate
an awareness on Petitioner's part that the survey disclosed deficiencies
in conditions of participation that required fundamental changes in the
way that the Petitioner would be providing care to its patients. These
are not lower level deficiencies. Ms. McGloghlon, the hired consultant, asserts that Petitioner
was in substantial compliance and had only "lower level deficiencies."
P. Br., at 17. She flatly contradicted HCFA's determination that Petitioner
was not in compliance with seven conditions of participation without explaining
the reasons behind her conclusion and based solely on second-hand information.
She reviewed only the Statement of Deficiencies and the plan of correction
for the December 10, 1997 survey. Id. She did not, as the surveyors
did, perform her own onsite compliance review nor did she perform a paper
compliance review at any time. Neither did she review relevant contemporaneous
records. In addition, she has not shown that she is familiar with Medicare
requirements of hospice programs. She made no reference to any training
or work experience in this area. She was not present at the time the December
10, 1997 survey was conducted. In light of these facts, I give her self-serving
statement little weight. In addition, Petitioner had not met the second element
of section 489.13(c)(2)(ii) because HCFA never accepted the February 18,
1998 plan of correction. Petitioner argues that it was given permission
to submit a plan of correction in a letter from the County of Los Angeles
Department of Health Services (LADHS) dated December 30, 1997. P. Ex.
4. Petitioner further reasons that HCFA is now compelled to accept the
plan of correction dated February 18, 1998 and certify Petitioner, as
of that date. Petitioner concedes that LADHS claimed that the plan of
correction letter, dated December 30, 1997, was inadvertently transmitted
to Petitioner. P. Br., at 15. Nevertheless, Petitioner seems to argue
that HCFA should be bound by this letter. However, HCFA cannot be compelled
to accept a plan of correction since a plan of correction may not adequately
address the deficiencies concerned or because a plan of correction may
not be an option available to the provider. When conditions of participation
are not met, the only option available to a provider is a new application
and a resurvey to determine compliance with conditions of participation.
LADHS inadvertently transmitted the plan of correction letter to Petitioner.
P. Br., at 15. The January 15, 1998 notice letter denying Petitioner's
Medicare application did not give Petitioner an opportunity to submit
a plan of correction. The January 15, 1998 notice letter only gave Petitioner
the option to reapply. Nevertheless, Petitioner filed a plan of correction
on February 18, 1998, when it evidently knew that this avenue was not
available to it. Even if HCFA could be compelled to accept Petitioner's
plan of correction, I find that HCFA is not compelled to certify Petitioner
as of February 18, 1998. As previously discussed, Petitioner had not met
the required elements of 42 C.F.R. � 489.13(c)(2)(ii). The Petitioner
had not meet all the conditions of participation, nor are the deficiencies
involved low level deficiencies. Petitioner further argues that the regulations and HCFA's
actions were such as to excessively delay certification and cause Petitioner
to incur large expenditures on behalf of its patients that were not reimbursed
by Medicare. This argument also must fail since it requests relief based
on principles of equity which I have no authority to grant under the regulations.
Therapeutic Rehabilitation Centers, Inc., DAB CR531 (1998). There
is no exception to the regulations that would permit HCFA to certify a
provider at a date earlier than the date of completion of the survey in
the circumstances where completion of the survey has been delayed for
reasons that are beyond the ability of the provider to control. Id. Alternatively, Petitioner argues that the effective date
of certification could be the date of the State licensing survey on August
12, 1997, or the date it received the CLHF license on September 26, 1997,
or the date of the Medicare certification survey on December 10, 1997,
even though Petitioner concedes that it was not in compliance on the date
of that survey. Neither of these dates are possible certification dates.
HCFA cannot base Medicare certification on a State licensing survey or
on the date a State license was issued. As stated in Arbor Hospital:
DAB No. 1591, at 7 n.6. HCFA cannot grant certification
until HCFA finds that a provider has met all the Medicare conditions of
participation. Id. Under the regulations, HCFA could not have granted a Medicare
provider agreement until, among other things, an onsite survey verified
that Petitioner had finally achieved compliance with all the conditions
of participation pertaining to hospice programs. 42 C.F.R. � 489.13(c)(2)(i).
This compliance was verified on April 14, 1998. April 14, 1998, is the
earliest date on which certification could have been granted. III. Conclusion HCFA correctly determined to certify Petitioner to participate in the Medicare program, effective April 14, 1998. |
|
JUDGE | |
Marion T. Silva Chief Administrative Law Judge
|
|