$05:Civil Money Penalty
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
CSM Home Health Services, Inc.,
Petitioner,
- v. -
Health Care Financing Administration.
Date: October 11, 1996
Docket No. C-96-363
Decision No. CR440
DECISION
I decide that the Health Care Financing Administration (HCFA) incorrectly determined
to terminate the
participation in the Medicare program of Petitioner, CSM Home Health Services,
Inc. In this case, HCFA
asserted that Petitioner failed to comply with four conditions of participation
in Medicare. I find that the
preponderance of the evidence is that Petitioner complied with all four of these
conditions. 1/
I. Background
A. Applicable law and regulations
Petitioner is a home health agency that participated in the Medicare program.
The services provided by
home health agencies that are covered by the Medicare program are described
in section 1861(m) of the
Social Security Act (Act). The statutory requirements of participation for a
home health agency are
described in section 1861(o) of the Act.
The Secretary of the United States Department of Health and Human Services
(Secretary) has published
regulations which govern the participation in Medicare of home health agencies.
These are contained in 42
C.F.R. Part 484. The regulations which define the Secretaryþs requirements
for Medicare participation of
home health agencies establish conditions of participation for these agencies.
42 C.F.R. 484.10 - 484.52.
The regulations express these conditions of participation as broadly stated
participation criteria. For
example, 42 C.F.R. 484.18 states as a part of the condition of participation
contained in that regulation
that care provided to patients by a home health agency must follow a written
plan of care that is established
and periodically reviewed by a physician.
The regulations also state standards of participation as subsidiary components
of the conditions of
participation. For example, in 42 C.F.R. 484.18, there are specific standards
governing: what a plan of
care must contain (42 C.F.R. 484.18(a)); who must review a plan of care and
when the plan must be
reviewed (42 C.F.R. 484.18(b)); and how a physicianþs orders, made pursuant
to a plan of care are to be
made, issued, and carried out (42 C.F.R. 484.18(c)).
The Secretary is required to determine whether a Medicare participant, including
a home health agency, is
complying substantially with the Medicare participation requirements established
by the Act and
regulations. Act, section 1866(b)(2). The Secretary may terminate the participation
in Medicare of a
provider which the Secretary finds not to be complying substantially with participation
requirements. Act,
section 1866(b)(2)(A).
The process and criteria for determining whether a provider is complying substantially
with Medicare
participation requirements are established by regulations contained in 42 C.F.R.
Part 488. 2/
Pursuant to the Act and regulations, the Secretary has entered into agreements
with State survey agencies
to conduct periodic surveys of providers, including home health agencies, in
order to ascertain whether
these providers are complying with Medicare participation requirements. Act,
section 1864(a); 42 C.F.R.
488.10, 488.11, 488.20.
HCFA may terminate the participation in Medicare of a provider that HCFA determines,
either on its own
initiative or based on a survey report from a State survey agency, is not complying
with one or more
Medicare conditions of participation. See 42 C.F.R. 488.20, 488.24, 488.26.
3/ Failure to comply with a
condition of participation occurs where deficiencies, either individually or
in combination, are:
. . . of such character as to substantially limit the providerþs . .
. capacity to furnish adequate care or
which adversely affect the health and safety of patients;
42 C.F.R. 488.24(b); see 42 C.F.R. 488.28(b).
Where HCFA determines that there is a deficiency, but that the deficiency is
not so severe as to constitute a
condition-level deficiency, then HCFA may not terminate the providerþs
participation in Medicare without
first affording the provider the opportunity to correct the deficiency. 42 C.F.R.
488.28.
Termination of participation is a remedy intended to protect the health and
safety of program beneficiaries
and not a punishment. Termination of participation should be invoked in the
circumstance where a
providerþs deficiencies establish that the provider is substantially incapable
of providing care consistent
with Medicare participation requirements. Termination should not be invoked
unless the evidence proving
a providerþs failure to comply with participation requirements establishes
that the provider cannot provide
care consistent with that which is required by the Act and regulations.
Generally, a determination as to whether a provider is not complying with a
condition of participation
depends on the extent to which that provider is found not to be complying with
the standards that are
components of the condition. 42 C.F.R. 488.26(b). A provider may be found not
to have complied with a
condition of participation where it is shown that a provider has committed a
pattern of failures to comply
with the standards that comprise the condition. But, proof of a pattern of failures
to comply with a
standard or standards may not be the only basis to find that a provider has
failed to comply with a condition
of participation. The determinative issue in any case where noncompliance is
demonstrated is whether the
failure to comply is so egregious as to show that the provider is not capable
of providing care consistent
with that which is required by the Act and regulations.
B. History of this case
On March 1, 1996, HCFA and the California State survey agency conducted a compliance
survey of
Petitioner. Based on that survey, Petitioner was found not to be complying with
eight conditions of
participation. HCFA Ex. 1. HCFA and the California State survey agency conducted
a second survey of
Petitioner which was completed on May 30, 1996. HCFA Ex. 3 at 2. On June 26,
1996, HCFA notified
Petitioner that, based on the second survey, HCFA had determined that Petitioner
was not complying with
four conditions of participation. HCFA Ex. 2. These conditions are:
(1) 42 C.F.R. 484.14 (Organization, services, and administration);
(2) 42 C.F.R. 484.18 (Acceptance of patients, plan of care, and medical supervision);
(3) 42 C.F.R. 484.30 (Skilled nursing services); and
(4) 42 C.F.R. 484.52 (Evaluation of the agencyþs program).
Id. at 2. HCFA terminated Petitionerþs participation in Medicare, effective
July 25, 1996. 4/
Petitioner requested a hearing, and the case was assigned to me for a hearing
and a decision. Petitioner
requested that I expedite the hearing and, consequently, I held a hearing in
Los Angeles, California, on
August 12 - 15, 1996. I ordered the parties to submit posthearing briefs and
reply briefs on an expedited
schedule. The parties complied with this briefing schedule. I base my decision
in this case on the
governing law, the evidence I received at the hearing, and on the partiesþ
arguments expressed in their
briefs and reply briefs.
II. Issue, findings of fact and conclusions of law
A. Issue
The issue in this case is whether HCFA correctly determined to terminate Petitionerþs
participation in
Medicare. As I have stated in Part I in this decision, HCFA may terminate a
providerþs participation in
Medicare if that provider is not complying with a Medicare condition of participation.
HCFA may not
terminate a providerþs participation in Medicare if that provider is not
complying with standards of
participation, but only if that noncompliance is not so egregious as to comprise
a failure to comply with a
condition of participation.
B. Findings of fact and conclusions of law
I base my decision that Petitioner did not fail to comply with any of the four
conditions of participation
which were cited by HCFA in its June 26, 1996 letter to Petitioner on the findings
of fact and conclusions
of law (Findings) which I set forth herein. I discuss each of my Findings, in
detail, at Part III of this
decision.
1. Petitioner has a right to a hearing.
2. The standard of participation contained in 42 C.F.R. 484.14(b) requires
a home
health agencyþs governing body to assume full legal responsibility for
the operation of the home health
agency. It may be inferred that a home health agency has not complied with this
standard where the
agency systematically fails to comply with the Medicare participation requirements
for home health
agencies.
3. The standard of participation contained in 42 C.F.R. 484.14(g) requires
a home
health agency to assure that there is effective communication and cooperation
among its staff along with
accurate documentation of whatever communication and cooperation that occurs.
The standard does not
suggest that such communication and cooperation is not attained simply because
a home health agency is
unable to attain all of the goals and objectives it establishes for the care
of a patient.
4. The standard of participation contained in 42 C.F.R. 484.18(a) requires
that a home
health agency assure that all pertinent diagnoses, treatments, and instructions
for caring for a patient be
included in a written plan of care. The standard of participation contained
in 42 C.F.R. 484.18(b) requires
that the plan of care be reviewed at least once every 62 days.
5. The standard of participation contained in 42 C.F.R. 484.30(a) requires that
a
registered nurse initiate a plan of care, initiate necessary revisions, and
initiate appropriate rehabilitative
and preventive nursing procedures. This standard means that a nurse must begin
to implement and carry
out all treatments that are ordered in a patientþs plan of care. This
standard does not impose on a registered
nurse the duty of writing a plan of care or of making revisions to a plan of
care.
6. Petitioner was not deficient in complying with standards of participation
in providing
care to Patient #s 1, 3, 5, 6, 7, 8, 10, 11, 13, and 15.
7. In providing care to Patient # 12, Petitioner failed to comply substantially
with a
standard of participation contained in 42 C.F.R. 484.18. Specifically, Petitioner
failed to follow a
directive in the patientþs plan of care that the skilled nurse assigned
to Patient # 12 assess the progress of
the patientþs disease (insulin-dependent diabetes mellitus), because the
skilled nurse failed to assess the
patientþs complaints of blurred vision, a possible sign of diabetes mellitus.
8. In providing care to Patient # 12, Petitioner failed to comply substantially
with a
standard of participation contained in 42 C.F.R. 484.18(b). Specifically, Petitioner
failed to assure that
the plan of care for Patient # 12 was revised to address a fungal infection
that had been diagnosed by the
patientþs physician and for which the physician had prescribed medication.
9. In providing care to Patient # 12, Petitioner failed to comply substantially
with a
participation requirement stated in 42 C.F.R. 484.30. Specifically, the nursing
staff assigned to Patient #
12 failed to fully discharge its duties to the patient, by not assessing the
patientþs complaints of blurred
vision.
10. Petitioner did not fail to conduct the management reviews and evaluations
required
under 42 C.F.R. 484.52.
11. Petitioner did not fail to comply with the condition of participation
stated in 42
C.F.R. 484.14.
12. Although Petitioner, in two instances involving a single patient, failed
to comply
with a standard of participation contained in 42 C.F.R. 484.18, Petitioner did
not fail to comply with the
condition of participation stated in 42 C.F.R. 484.18.
13. Although Petitioner, in one instance involving one patient, failed to
comply with a
requirement of 42 C.F.R. 484.30, Petitioner did not fail to comply with the
condition of participation
stated in 42 C.F.R. 484.30.
14. Petitioner did not fail to comply with the condition of participation
stated in 42
C.F.R. 484.52.
15. Petitioner did not establish good cause for me to waive its share of the
cost of the
transcript.
III. Discussion
HCFA alleges that Petitioner failed in numerous instances to comply with Medicare
participation
requirements. Below, I explain why nearly all of HCFAþs allegations are
without merit.
HCFAþs allegations constitute particularized statements of asserted failures
by Petitioner to comply with
Medicare participation requirements. I have analyzed these assertions on an
item-by-item basis. But, it is
apparent that many of HCFAþs allegations share common features. My decision
that nearly all of HCFAþs
allegations are without merit is, in some respects, based on the way I analyze
these common features. The
features which many of HCFAþs allegations share, and my overall conclusions
about these common
features, are as follows.
HCFA bases many of its allegations that Petitioner was deficient on an interpretation
of a participation
requirement in 42 C.F.R. 484.30(a) which does not comport with the plain meaning
of the language of the
regulation. HCFA asserts that the regulationþs requirement that a nurse
þinitiateþ revisions to a patientþs
plan of care means that the nurse must make revisions to address new problems
encountered by a patient or
to fill in the gaps left in a patientþs plan of care. I find that the
regulation imposes no duty on a nurse to
usurp the duty of a physician to write and revise a patientþs plan of
care. It requires only that a nurse begin
to implement those revisions in a plan of care that are directed by a physician.
HCFA asserts that the coordination of services and liaison among staff required
by 42 C.F.R. 484.14(g)
must be judged by the results that are achieved in providing care to a patient.
I find that the results attained
in a particular case do not necessarily determine the efforts made to attain
the goals set for a patient by a
physician.
HCFA argues, in some instances, that documentation of coordination of services
and liaison must consist
of reports of staff meetings. I find that, while a report of a staff meeting
may document coordination of
services and liaison, coordination of services and liaison is not necessarily
absent in a case where there is
no documentation of a staff meeting to discuss a patientþs care.
HCFA frequently bases multiple assertions of deficiencies on a single alleged
event. I do not disagree
with HCFAþs conclusion that a single set of facts may evidence a failure
by a provider to comply with
more than one participation requirement. However, while that may be so, it is
true also that where the facts
are other than that which is alleged by HCFA, then HCFAþs assertion of
multiple deficiencies based on the
alleged facts may be without foundation.
In several instances in this case, HCFA asserts that a þdischarge objectiveþ
in a patientþs plan of care
constitutes a treatment goal by the patientþs physician. On that premise,
HCFA asserts a multiplicity of
failures by Petitioner including: failures to assure that the patientþs
plan of care contains orders for
treatment to meet the asserted þgoalþ; failures of Petitionerþs
staff to attempt to meet the asserted þgoalþ;
and failures of Petitionerþs nurses to revise the plan of care to provide
treatment regimes necessary to meet
the asserted þgoal.þ
I find, contrary to HCFAþs assertions, that in many cases the physicians
who treated the patients did not
intend that the discharge objectives in the patientþs plans of care be
interpreted as stating treatment goals
that the physicians sought to attain for their patients. Rather, the discharge
objectives merely stated þbest
of all possible worldsþ outcomes to cases, that no professional thought
to be likely. This is significant,
because I do not find that Petitioner was responsible for attaining results
that the patientsþ physicians did
not direct Petitioner to attain.
In many instances, HCFA rests its allegations on characterizations of facts
which are not supported by the
evidence. In some instances, HCFA asserts that nurses employed by Petitioner
failed to discharge specific
directives in patientsþ plans of care when, in fact, the record proves
that they did precisely what they were
ordered to do. HCFA asserts also that Petitioner failed to conduct a required
program evaluation despite
overwhelming evidence that Petitioner performed the evaluation.
A. Whether Petitioner has a right to a hearing
(Finding 1)
HCFA argued that Petitioner might no longer qualify as a provider and, therefore,
might not have a right to
a hearing. HCFA suggested that, perhaps, another entity should be substituted
as a party in place of
Petitioner. Alternatively, HCFA suggested that, perhaps, the matter should be
remanded to HCFA for a
determination as to whether Petitioner is a party. Tr. at 15 - 25.
HCFA has not elaborated on its arguments in its posthearing brief. It has not
explained why, assuming the
facts that it alleges to be true, Petitioner has no right to a hearing. It may
be that HCFA no longer is
asserting that Petitioner may not have a right to a hearing.
HCFA based its motion on a memorandum, dated July 31, 1996, that was issued
by Petitionerþs
administrator. HCFA Ex. 23. 5/ In that memorandum, the administrator announced
that Petitioner was
merging with another facility. According to HCFA, the announced merger raised
the possibility that
Petitioner would no longer exist as an entity that qualified to be a provider
under applicable regulations.
Petitioner responded to HCFAþs motion with a declaration by its owner,
Mariano Velez, dated August 15,
1996. P. Ex. 31. 6/ In that declaration, Mr. Velez denies that Petitioner merged
into another entity. He
avers that Petitioner entered into an agreement with another facility to transfer
patients to that facility
temporarily. Additionally, pursuant to that agreement, the other facility will
employ Petitionerþs staff on a
temporary basis. P. Ex. 31 at 2, 7 - 8.
HCFA has not identified the law or regulations that would operate to deny Petitioner
the right to a hearing
in this case, assuming that it did merge with another entity. In any event,
I find from Mr. Velezþ
unrebutted declaration that Petitioner did not merge with another entity. Therefore,
I do not accept as
correct the premise of HCFAþs motion.
B. The participation requirements that are at issue
(Findings 2 - 5)
HCFA asserts that Petitioner failed to comply with requirements that are expressed
as conditions of
participation or as standards of conditions under governing regulations. As
a prerequisite to deciding
whether HCFAþs assertions are correct, I must decide what obligations
these conditions and standards
impose on Petitioner.
The question of interpretation of regulations is one which arises often in
cases involving Medicare
participation requirements. The Secretary has published comprehensive regulations
governing the
conditions for participation by a wide range of providers. But, no matter how
comprehensive these
regulations may be, questions of interpretation and application will arise inevitably.
The ways in which
health care providers provide care to their patients are so varied and complex,
and so dependent on the
unique circumstances pertaining to each patient, that it is not possible to
write regulations that explicitly
account for every fact situation that might arise.
HCFA is the agency that bears primary responsibility for the application of
regulations governing
participation in the Medicare program. Its reasonable interpretations of regulations
must be given
deference. I will not question HCFAþs interpretation of a regulation,
where that interpretation is
reasonable, even if there may exist other, equally reasonable, interpretations
of that regulation.
On the other hand, HCFA does not have carte blanche to interpret regulations
as it sees fit. Where HCFA
seeks to hold a provider accountable to an interpretation of a regulation, that
interpretation must be
reasonable. In order to be reasonable, the interpretation must comport with
the meaning of the language of
the regulation.
When the allegations contained in the survey report on which HCFA based its
determination to terminate
Petitionerþs participation are read critically, it becomes apparent that
HCFA is, in some instances, relying
on its interpretations of regulations as a basis for asserting that Petitioner
failed to comply with the
standards contained in those regulations. HCFA Ex. 4. However, the question
of whether HCFA is
interpreting regulations reasonably is complicated by the fact that HCFA has
not stated explicitly what its
interpretations are. HCFAþs interpretations must be inferred from the
allegations of failures to comply that
are stated in the survey report.
Therefore, as a first step in deciding whether Petitioner failed to comply
with Medicare participation
requirements, I turn to the survey report and identify each requirement that
HCFA asserts Petitioner failed
to comply with. I decide whether, in asserting noncompliance with a requirement,
HCFA is relying on the
plain meaning of the requirement or an interpretation, and, if HCFA is relying
on an interpretation, whether
the interpretation is reasonable.
1. Condition of participation: Organization,
services, and administration -- 42 C.F.R.
484.14 (Findings 2 - 3)
HCFA asserts that Petitioner failed to comply with two standards prescribed
under this condition, which
are set forth at 42 C.F.R. 484.14(b) and 484.14(g). HCFA Ex. 4 at 1 - 11. According
to HCFA, the
þsystemicþ failure of Petitioner to comply with these standards
establishes Petitionerþs failure to comply
with the condition. Id. at 1.
a. Standard: Governing body -- 42
C.F.R. 484.14(b)
This standard requires that a home health agencyþs governing body assert
full control over the agencyþs
operations. According to HCFA, Petitioner failed to comply with this standard
because Petitionerþs
governing body failed to assume full responsibility for Petitionerþs operations.
HCFA Ex. 4 at 2. HCFA
argues that Petitionerþs failure to comply with this standard may be inferred
from Petitionerþs asserted
failures to comply with standards of participation that govern the care that
Petitioner must provide to its
patients. This argument is made clear by the testimony of one of the surveyors
who participated in the
survey ending May 30, 1996, Helen Donna Dymon, Ph.D. Tr. at 225 - 227.
HCFAþs reading of the standard is not so much an interpretation as it
is a statement of the evidence which
may prove that the standard has not been complied with. I agree with HCFA that,
where a home health
agency is shown to have failed systematically to comply with Medicare participation
requirements, an
inference may be made that the agencyþs governing body failed to assume
authority and responsibility for
the agencyþs operations. However, the opposite inference may be made where
there
is no evidence of systematic failure by a home health agency to comply with
standards governing patient
care.
b. Standard: Coordination of
patient services -- 42 C.F.R.
484.14(g)
This standard requires a home health agency to insure that all personnel furnishing
services maintain
liaison so that their efforts to provide care are coordinated effectively and
support the objectives outlined in
patientsþ plans of care. HCFA asserts that, in a number of instances,
Petitioner failed to satisfy this
requirement.
The standard contains the key words and phrases þliaisonþ and þeffective
interchange, reporting, and
coordination of patient care.þ These are not defined. It is evident, however,
that this standard requires a
home health agency to assure that there is effective communication and cooperation
among its staff along
with accurate documentation of whatever communication and cooperation that occurs.
Many of the assertions made by HCFA concerning Petitionerþs alleged failures
to comply with the
standard appear to be based on the plain meaning of the standard. However, HCFA
appears also to argue
that, to some extent, it is gauging the degree of liaison, cooperation, and
coordination of services that
Petitioner provided on the outcomes in individual cases. Thus, for example,
HCFA asserts that, in
providing care to Patient # 12, Petitioner failed to provide liaison or to coordinate
services to assure that the
patient could demonstrate foods from an exchange list because þthere was
no documentation that showed
the patient could demonstrate foods from an exchange list . . . ." HCFA
Ex. 4 at 3.
I do not agree that compliance with the standard depends on the outcome of
care provided to a patient. The
standard requires liaison and coordination of services in order to assure that
the patient attains the best
possible outcome, consistent with the goals established for that patient by
the patientþs plan of care. But,
the regulation does not suggest that the degree of liaison and coordination
that is attained necessarily may
be measured by the home health agencyþs success in providing care to the
patient.
Additionally, HCFA seems to be asserting that certain indicia of liaison and
coordination must be present
in a patientþs record, either to establish that liaison and coordination
occurred in the care provided to that
patient, or to establish documentation of the liaison and care that the home
health agency provided. In
some instances, HCFA asserts that documentation of case conferences held by
Petitionerþs staff failed to
establish liaison or coordination of services provided to patients. For example,
HCFA asserts that a case
conference that was held to discuss care provided to Patient # 8 failed to document
an asserted goal that the
patient would no longer need a Foley catheter. HCFA Ex. 4 at 10 - 11.
HCFAþs assertion is not so much an interpretation of the regulation as
it is a statement of the evidence that
is necessary to prove compliance with the regulation. I do not agree that the
standard requires that a
patientþs record contain a specific type of document (such as a case conference
report) in order to
document liaison or coordination of care. Nor do I find that the standard requires
that case conferences, as
opposed to other types of communication, must occur in order for liaison and
coordination of services to be
present. The regulation does not specify the type of communications that must
take place and be
documented.
2. Condition of participation: Acceptance of
patients, plan of care, and medical
supervision -- 42 C.F.R. 484.18 (Finding 4)
This condition of participation requires, among other things, that care provided
to a patient by a home
health agency follow a written plan of care. HCFA asserts that Petitioner failed
to comply with the
requirement of the condition that care provided to patients follow written plans
of care. HCFA Ex. 4 at 12
- 15. HCFA asserts also that Petitioner failed to comply with the requirements
of standards contained in 42
C.F.R. 484.18(a) and (b). HCFA characterizes these asserted failures to comply
with standards as
þsystemicþ and concludes that they prove that Petitioner failed
to comply with the condition of
participation. HCFA Ex. 4 at 11.
a. Standard: Plan of care -- 42
C.F.R. 484.18(a)
The standard stated in 42 C.F.R. 484.18(a) requires that all pertinent diagnoses,
treatments, and
instructions for caring for a patient be included in a written plan of care.
In asserting that Petitioner failed
to comply with this standard, HCFA does not appear to be asserting that the
standard means anything more
than it plainly says.
However, HCFAþs allegations that Petitioner failed to develop plans of
care that comply with the standard
depend heavily on HCFAþs characterization of the contents of the individual
plans of care that are at issue
in this case. As I shall discuss below, in several instances I do not agree
with HCFAþs characterization of
the contents of individual plans of care.
b. Standard: Periodic review of
plan of care -- 42 C.F.R.
484.18(b)
The standard requires that a physician and the home health agency staff review
a plan of care as often as a
patientþs condition warrant, but at least once every 62 days. HCFA argues
that, in some instances,
Petitioner failed to assure that plans of care were reviewed as often as was
necessary. HCFA alleges that,
in other instances, Petitionerþs staff failed to alert the patientþs
physician of changes that suggested a need
to alter the patientþs plan of care.
It does not appear from HCFAþs characterization of Petitionerþs
alleged failures to assure review of
patientsþ plans of care that HCFA is interpreting this standard in a way
that deviates from the standardþs
plain meaning. The standard plainly requires that a patientþs physician
review the patientþs plan of care
where a change in the patientþs condition necessitates the review. As
I shall discuss below, the
determinative question in the three instances cited by HCFA is whether HCFA
is correct in its assertion
that reviews were necessary in those instances.
Nor does it appear from HCFAþs assertions about the alleged failures
of Petitionerþs staff to notify
patientsþ physicians about changes in the condition of the patients that
suggested a need to alter the
patientsþ plans of care that HCFA is interpreting the standard in a way
that departs from the standardþs
plain meaning. The standard requires that a home health agencyþs staff
notify a patientþs physician about
any changes in a patientþs condition which, based on the objective signs
and symptoms manifested by the
patient and on the professional training and judgment of the staff, might suggest
a need to alter a plan of
care. The dispositive question here is not one of interpretation but one of
fact: whether HCFA is correct in
asserting that there were changes in the conditions of patients that suggested
a need to alter the patientsþ
plans of care.
3. Condition of participation: Skilled nursing
services -- 42 C.F.R. 418.30 (Finding 5)
HCFA asserts that Petitioner failed to comply with the conditionþs requirement
that a home health agency
furnish skilled nursing services to each patient in accordance with a plan of
care. In making this assertion,
HCFA relies on the plain meaning of the language of the condition. The condition
states, simply, that
skilled nursing services must be furnished to a patient in accordance with the
patientþs plan of care. In
each of the instances cited, HCFA alleges that the skilled nurse failed to make
observations and
assessments that the patientþs physician directed the nurse to make. Therefore,
the issue in resolving these
allegations is one of fact, which I discuss below.
a. Standard: Duties of the
registered nurse -- 42 C.F.R.
484.30(a)
HCFA makes several assertions concerning Petitionerþs alleged failures
to comply with this standard.
First, HCFA asserts that nurses employed by Petitioner failed to reevaluate
regularly the needs of patients.
HCFA Ex. 4 at 28 - 35. Second, HCFA asserts that nurses employed by Petitioner
failed to initiate
necessary revisions to patientsþ plans of care. HCFA Ex. 4 at 35 - 41.
Third, HCFA asserts that nurses
employed by Petitioner failed to initiate appropriate preventive and rehabilitative
nursing procedures.
HCFA Ex. 4 at 41 - 44. Finally, HCFA asserts that nurses employed by Petitioner
failed to coordinate
services to patients. HCFA Ex. 4 at 45.
The regulation requires the registered nurse to: assess a patientþs problems
and needs, to provide care to
the patient, coordinate the care provided by other care givers, report to the
physician any significant
changes in a patientþs condition, and keep accurate records of the care
that the nurse provides. HCFAþs
assertions that, in specified instances, registered nurses failed to: reevaluate
the needs of patients, assess the
conditions of patients, or coordinate services rest on a straightforward application
of the standard to the
facts, as alleged by HCFA.
However, HCFAþs allegations that registered nurses failed to initiate
changes in plans of care or failed to
initiate appropriate preventive and rehabilitate nursing procedures rest on
an interpretation of the standard
that does not comport with the standardþs plain meaning and which is inconsistent
with the Act and other
Medicare regulations. I do not find HCFAþs interpretation to be reasonable.
The standard directs registered nurses to þinitiateþ a patientþs
plan of care and necessary revisions to the
plan of care. 42 C.F.R. 484.30(a). HCFA interprets the word þinitiateþ
to mean that the registered nurse
is charged with the independent responsibility to make changes in the patientþs
plan of care and in the
treatments provided to the patient, where the plan of care fails to prescribe
the appropriate treatment, or
where there is a change in the patientþs condition that might require
a change in treatment.
Contrary to HCFAþs assertion, the regulation does not impose on registered
nurses employed by home
health agencies the duty to make changes to patientsþ plans of care, even
where changes are warranted.
Under applicable participation requirements, only a physician may write or revise
a plan of care, although
the plan of care may be based on the assessments and advice provided by a nurse.
But, the nurseþs duty to
provide advice is not congruent with the authority to write or to revise a plan
of care.
The Act requires that each plan of care for each patient treated by a home
health agency be established by a
physician, and not by another care giver, such as a nurse. The Act states that
home health services are
enumerated services furnished to an individual who:
. . . is under the care of a physician, . . . under a plan (for furnishing
such items or services to such
individual) established and periodically reviewed by a physician . . . .
Act, section 1861(m) (emphasis added).
The intent of Congress that only a physician may write a plan of care is restated
in the regulations
governing home health agencies. The regulations state that care provided by
a home health agency follows
a written plan of care established and periodically reviewed by a physician.
42 C.F.R. 484.18. And,
although this language is plain on its face, its purpose is underscored by the
requirement that:
Drugs and treatments are administered by agency staff only as ordered by the physician.
42 C.F.R. 484.18(c) (emphasis added).
The standard contained in 42 C.F.R. 484.30(a) does not suggest any inconsistency
with these explicit
requirements. The plain meaning of the language of the standard, including the
word þinitiate,þ is that the
registered nurse is charged with the duty to begin and to carry out all treatments
ordered by a physician.
There is nothing in this language to suggest that a registered nurse is charged
with the authority of revising
a plan of care on his or her own volition, to assure that a patient receives
the necessary care. The duty to
þinitiateþ revisions to a plan of care and the duty to þinitiateþ
appropriate nursing and rehabilitative
procedures are not duties to use initiative to make changes to a plan of care.
The common and ordinary meaning of the word þinitiateþ is to cause
or facilitate the beginning of an
event, or to set something going. Websterþs New Collegiate Dictionary,
594 (8th ed. 1967). Literally,
þinitiateþ means to start something. Thus, when given its literal
meaning, the word þinitiateþ in 42 C.F.R.
484.30(a) means that the registered nurse is charged with the duty to start
implementing those treatments
that have been ordered by a physician. Nothing more is suggested by the word.
At the completion of the hearing, HCFA averred that it wished to call as a
rebuttal witness a HCFA
employee who participated in drafting regulations, including 42 C.F.R. 484.30.
The purpose of the
testimony was to explain what HCFA meant by the use of certain words in the
regulations. I ruled that
testimony to be irrelevant, and I reaffirm that ruling here. Tr. at 1063 - 1065.
There is nothing ambiguous about 42 C.F.R. 484.30(a) which needs to be interpreted
through extrinsic
evidence. The language of the regulation is plain and self-evident. And, while
it may be appropriate to use
extrinsic evidence, such as interpretive guidelines, a regulationþs preamble
and comments, or an agencyþs
official statements of interpretation, as a means of interpreting an unclear
or arguably ambiguous
regulation, it is not appropriate to use the opinions of agency employees who
participated in drafting a
regulation to establish the meaning of a regulation.
The purpose of a regulation is to provide a neutral standard which can be read,
understood, and applied by
those who are affected by it. Thus, the words in a regulation must be defined
based on their common and
ordinary meaning, or on any special meaning set forth in a regulationþs
definition, or in the legislative
history to the regulation. The words in a regulation cannot be defined after
the fact by the testimony of the
employee who used the words in drafting the regulation. If such were the case,
then the regulation would
lose any pretense of neutrality, and the concept of standards embodied in a
regulation would be
meaningless. 7/ That is particularly evident where, as here, the key word þinitiateþ
has a common and
ordinary meaning, and where nothing in the regulations suggest that it was intended
to be applied in
another sense.
4. Condition of participation: Evaluation of
the agencyþs program -- 42 C.F.R. 484.52
HCFA asserts that Petitioner failed in a þsystemicþ way to comply
with the conditionþs requirement that
Petitioner: assess the extent to which its program was appropriate, adequate,
effective and efficient; act
upon the results of its evaluation; and, review its own administrative practices.
HCFA Ex. 4 at 46 - 48.
HCFAþs interpretation of the requirements of this condition does not appear
to depart from its plain
meaning. The issue, as I see it, is one of fact and not of law.
a. Standard: Policy and
administrative review -- 42 C.F.R.
484.52(a)
HCFA is relying on the plain meaning of this standard in asserting that Petitioner
failed to conduct
requisite management reviews. The question as to Petitionerþs compliance
with this standard, therefore, is
one of fact and not of law.
C. HCFA's allegations that Petitioner was deficient
in providing care to patients (Findings 6 - 9)
I now turn to a patient-by-patient discussion of each of the patients to whom
HCFA alleges Petitioner
provided substandard care. I evaluate each of HCFAþs allegations based
on the duties imposed on
Petitioner under the relevant regulations, coupled with my analysis of the relevant
evidence.
That evidence consists largely of the patientsþ treatment records. At
the hearing, both HCFA and
Petitioner introduced into evidence treatment records for the patients at issue.
There is considerable
overlap in the exhibits, in the sense that many of the pages of the records
introduced by HCFA are
contained also in the records introduced by Petitioner. However, HCFAþs
exhibits and Petitionerþs
exhibits are not congruent. There are records of treatment in HCFAþs exhibits
that do not appear in the
corresponding exhibits introduced by Petitioner, and vice versa. Neither party
offered an explanation for
these differences. I find that, in order to get the best possible picture of
the care provided by Petitioner to a
patient, it is necessary to read both the relevant HCFA exhibit and the relevant
Petitioner exhibit as
comprising one record of the care provided to that patient. 8/
1. Patient # 1 (HCFA Ex. 5, P. Ex. 9)
HCFA alleges that, in providing care to Patient # 1, Petitioner failed to comply
with the following
Medicare participation requirements: 42 C.F.R. 484.14(g) (HCFA Ex. 4 at 7 -
8); 42 C.F.R. 484.18(b)
(HCFA Ex. 4 at 21 - 22, 24 - 25); and 42 C.F.R. 484.30(a) (HCFA Ex. 4 at 28,
30 - 32, 35 - 36, 41 - 42,
45). I find that Petitioner was not deficient in providing care to this patient.
Patient # 1 was certified to be cared for by Petitioner beginning April 7, 1996
and ending June 7, 1996.
HCFA Ex. 5 at 1, P. Ex. 9 at 1. Her principal diagnosis was a urinary tract
infection. Id. Other diagnoses
included: a decubitus ulcer, hypertension, ASCVD, and urinary incontinence.
Id.
An evaluation of the patient, performed on April 2, 1996, showed that the patient
was oriented to her name
only, that she was disoriented and confused. HCFA Ex. 5 at 8 - 9, P. Ex. 9 at
3 - 4. She was observed to
speak only when spoken to or stimulated. She manifested a flat affect and was
withdrawn. HCFA Ex. 5 at
9, P. Ex. 9 at 4.
a. 42 C.F.R. 484.14(g)
HCFA alleges that, in providing care to Patient # 1, Petitionerþs staff
failed to insure that the patientþs
clinical records or minutes of case conferences established effective interchange,
reporting, and
coordination of patient care. Specifically, HCFA asserts that the clinical notes
and plan of care for this
patient did not show documentation concerning coordination of the patientþs
care with consideration to the
patientþs emotional status concerning the patientþs grief and depression,
resulting from the suicide of the
patientþs grandson-in-law.
However, the record establishes otherwise. Petitionerþs staff actively
communicated with each other, with
the patientþs physician, with the social worker who was retained to provide
specialized care, and with the
patientþs care giver, concerning the grief experienced by the patient
and by the care giver. I find no
deficiency in the coordination of care provided to Patient # 1.
On April 18, 1996, the registered nurse reported to the patientþs physician
that the patientþs care giver
needed more assistance because the care giver was overwhelmed with the care
of the patient, and with the
care of the care giverþs two younger children. HCFA Ex. 5 at 4, P. Ex.
9 at 30. The nurse reported also
that the care giverþs husband had been hospitalized in an intensive care
unit for an attempted suicide. Id.
The nurse reported that she had offered the care giver intervention by a social
worker to assist with the care
giverþs family situation, but that the care giver had declined the offer.
Id.
On April 23, 1996, the registered nurse (who also served as Petitionerþs
Director of Nursing) left a
message with the physician concerning the patientþs need for counseling
and crisis intervention. HCFA
Ex. 5 at 6, P. Ex. 9 at 20. The nurse reported that the patientþs grandson-in-law
had expired two days
previously. Id. The nurse informed the physician that the patientþs care
giver had stated that she would be
unable to provide proper care for the patient due to the care giverþs
grief. Id. The nurse advised
additionally that the patient also was in a state of grief and depression. Id.
Later that day, the nurse called
back to the patientþs physician. The physician agreed to order a referral
to a social worker for counselling
and crisis intervention. Id. The nurse informed both the patientþs care
giver and the nurseþs clinical
supervisor of the physicianþs order. Id.
Pursuant to the physicianþs order, a social worker visited the patient
and the care giver on April 25, 1996.
P. Ex. 5 at 32, P. Ex. 9 at 60. The social worker reported the patientþs
mental status as being disoriented
and confused at times. She reported also that the patient did not speak. Id.
Additionally, the social worker
reported that the patientþs care giver was not coping with the patientþs
illness. Id. The social worker
wrote a patient care plan for social services. P. Ex. 9 at 61.
On April 29, 1996, a meeting of Petitionerþs staff was convened to discuss
the care that Petitioner was
providing to Patient # 1. Those present included two registered nurses, a home
health aide, and a patient
care coordinator. P. Ex. 9 at 37. At the meeting, it was reported that the patientþs
family was grieving the
loss of a loved one. It was reported also that the interventions that had been
provided to address this
problem included allowing the family to ventilate its feelings, and providing
emotional support. Id.
On May 24, 1996, the social worker wrote a discharge summary. HCFA Ex. 5 at
30, P. Ex. 9 at 62. The
discharge summary repeats the finding that the patient did not speak. It noted
that the social worker had
provided counseling to family members of Patient # 1. Id. Also, on May 24, the
social worker reported to
the registered nurse. P. Ex. 9 at 33. The social worker enumerated the resources
that she had provided to
the patientþs family and she stated that no further intervention was required.
P. Ex. 9 at 33.
These interventions were discussed at a meeting of Petitionerþs staff
held on May 24, 1996. Present were a
registered nurse, a home health aide, the patient care coordinator, and a social
services worker. P. Ex. 9 at
38.
HCFAþs major criticism of the interventions that were supplied to address
the grief and distress caused by
the suicide of the grandson-in-law of Patient # 1 is that not much was done
for the patient directly. The
proof relied on by HCFA is that the interventions provided by the social worker
mainly were directed at
addressing the concerns expressed by the patientþs family.
But, this criticism begs the question of whether Petitionerþs staff provided
the coordination of care and
liaison required under the regulation. The quality of care provided to the patient
by the social worker is not
at issue here. What is at issue is whether Petitionerþs staff reacted
appropriately to the information which
was communicated to them by the social worker. From the record before me, it
is evident that they did.
Contrary to HCFAþs assertions of no coordination or liaison, the record
establishes that a high degree of
coordination and liaison occurred. The registered nurse communicated the problems
being experienced by
the patient and her family to the physician, who promptly order intervention
by a social worker. The social
worker communicated her findings and her interventions to the registered nurse,
who promptly shared
these findings and interventions with other members of Petitionerþs staff
who were concerned with
providing care to the patient.
Although the quality of care provided by the social worker may not be relevant
to deciding whether
Petitioner provided appropriate liaison and coordination, I am not persuaded
from the evidence that the
interventions of the social worker were inappropriate or inadequate, given the
circumstances she
confronted. Patient # 1 was uncommunicative and withdrawn and her mental status
was impaired. The
social workerþs notes establish that the patient did not speak in the
social workerþs presence. HCFA Ex. 5
at 32, P. Ex. 9 at 60. Given that, it was entirely logical for the social worker
to have focused on the grief
and distress being expressed by other members of the patientþs family,
especially that of the care giver.
Moreover, HCFA fails to acknowledge that it might have been beneficial to the
welfare of Patient # 1 for
the social worker to have focused on allaying the grief of the care giver. The
patientþs care giver was an
important member of the team of individuals who provided care to patient # 1.
The care giver had told the
patientþs nurse that she was overwhelmed with grief and was unable to
provide care, as a consequence.
Dealing with that grief was an important issue for Petitioner to attempt to
resolve.
At the hearing, one of the surveyors, Virgilio Resurreccion, testified that
he had ascertained, by calling the
patientþs family, that there had been no further intervention by the social
worker after May 24, 1996. Tr.
at 437 - 438. That testimony is not inconsistent with the social workerþs
evaluation and discharge
summary, however.
b. 42 C.F.R. 484.18(b)
HCFA asserts that, in providing care to Patient # 1, Petitioner failed in two
respects to comply with the
standard contained in 42 C.F.R. 484.18(b). First, HCFA argues that the patientþs
physician failed to
review and revise the patientþs plan of care to deal with the grief that
the patient suffered as the result of
the suicide of her grandson-in-law. HCFA Ex. 4 at 21 - 22. Second, the record
failed to document that the
physician was alerted to the social workerþs findings that þsuggested
a need to alter the plan of care.þ Id. at
24 - 25. I have discussed the record of Petitionerþs attention to the
patientþs grief, above.
The standard contained in 42 C.F.R. 484.18(b) requires that a plan of care
be revised by the physician, in
consultation with a home health agencyþs staff, as often as the patientþs
condition requires, but at least
once every 62 days. In this case, HCFA assumes, without offering evidence to
support its assumption, that
the patientþs condition required a review of her plan of care within 62
days. However, it is evident from
the record that the social worker who visited the patient and Petitionerþs
staff were in accord that any grief-
related problems were not so severe as to require further intervention by the
physician. HCFA has offered
no evidence to suggest that this judgment is incorrect. Moreover, HCFA has made
no assertion as to what
it thought the patientþs physician ought to have done other than what
the physician did, which was to order
intervention by a social worker.
Indeed, the judgment of Petitionerþs staff and of the social worker is
entirely consistent with what the
patientþs physician ordered. There is nothing in the record to suggest
that the physician believed that the
patient required any intervention beyond that which was offered by the social
worker. The physician did
not order that the patient be seen by a psychiatrist or by a psychologist. The
social worker did not report
that such intervention was needed.
c. 42 C.F.R. 484.30(a)
HCFA makes several allegations concerning Petitionerþs alleged failure,
in providing care to Patient # 1, to
comply with the standard contained in 42 C.F.R. 484.30(a). First, HCFA alleges
that the registered nurse
who treated the patient failed to reevaluate the patientþs needs relative
to the consultation between the
patient, her care giver, and the social worker. HCFA Ex. 4 at 30. I find this
allegation to be unsupported
by the record. The premise for this allegation is that, after the social worker
completed her intervention,
there was a need for the nurse to reevaluate the patientþs needs. However,
the record establishes that, on
May 24, 1996, the social worker advised the nurse that no further interventions
were necessary in the case
of Patient # 1. HCFA Ex. 5 at 30 - 32, P. Ex. 9 at 60 - 62. HCFA has not explained
what reevaluation the
nurse should have done in light of the social workerþs report.
Second, HCFA asserts that the registered nurse failed to reevaluate the patientþs
need to use a Foley
catheter. HCFA Ex. 4 at 31 - 32. HCFA premises this assertion on the argument
that, under professionally
recognized standards of care, a Foley catheter ought to be worn by a patient
for the briefest period of time.
HCFA Exs. 20 - 22. Here, according to HCFA, the nurse provided care to the patient
without taking these
standards of care into account, thus ignoring her obligation to make a judgment
as to whether the patient
would benefit from continued use of the catheter.
I am not persuaded that the registered nurse failed to discharge her duty to
Patient # 1. It is evident from
the records for the patient that the physicianþs objective with respect
to Patient # 1 for the certification
period ending on June 7, 1996 was to assure that the patientþs Foley catheter
was working properly and
that the patientþs urinary tract infection was resolved. HCFA Ex. 5 at
1, P. Ex. 9 at 1. The nurse was
never charged with the responsibility of assessing whether continued use of
the catheter was necessary.
The patientþs physician did not contemplate even the possibility that
the patient would not need to wear the
catheter throughout the certification period. In light of that, it does not
make sense to expect the nurse who
visited the patient on behalf of Petitioner to determine whether continued use
of the catheter was
appropriate. 9/
The patientþs physician prescribed a Foley catheter to be worn by the
patient throughout the period of
certification. HCFA Ex. 5 at 1, P. Ex. 9 at 1. The discharge plan statement
in the patientþs plan of care
explicitly contemplated that the patient would be discharged when she had a
patent catheter, without
complications. HCFA Ex. 5 at 2, P. Ex. 9 at 2. Moreover, the records of treatment
for Patient # 1 include
communications between the nurses who treated the patient and the physician
concerning the patientþs
ongoing urinary tract infection and discussing the care that the nurse was to
provide, including
management of the patientþs Foley catheter. P. Ex. 9 at 22. There is nothing
in these records to suggest
that, at any time during the certification period ending on June 7, 1996, the
patientþs physician considered
that a Foley catheter might not be appropriate for the patient.
Third, HCFA asserts that the registered nurses that Petitioner assigned to
provide care to Patient # 1 failed
to make necessary revisions to the patientþs plan of care. HCFA Ex. 4
at 36. Specifically, HCFA asserts
that there is no documentation in the patientþs treatment records to establish
that registered nurses made
necessary revisions to the patientþs plan of care to address the patientþs
grief over the suicide of her
grandson-in-law. Id.
As I discuss at Part III.B.3.a. of this decision, HCFA misinterprets 42 C.F.R.
484.30(a) to require nurses
to make revisions to plans of care when, in fact, the regulation does not contain
this asserted requirement.
Thus, HCFAþs assertion that Petitioner was deficient because registered
nurses employed by Petitioner
failed to revise the plan of care for Patient # 1 is without merit. Moreover,
as I explain above in my
discussion of Patient # 1, I am not persuaded that any revisions to the patientþs
plan of care were necessary
in any event.
Fourth, HCFA asserts that the registered nurses failed to initiate appropriate
preventive and rehabilitative
nursing procedures for Patient # 1. HCFA Ex. 4 at 42. Specifically, HCFA asserts
that the nurses failed to
initiate þappropriate rehabilitative nursing procedures consistent with
guidelines for assessment for
continued use of Foley catheters.þ Id.
It is unclear what HCFA means by this allegation. However, when it is read
in context with the other
allegations that HCFA makes concerning Petitionerþs care of Patient #
1, it appears that HCFA is again
asserting that the nurses employed by Petitioner should have, on their own volition,
made decisions about
the patientþs continued use of a Foley catheter. Such independent action
is not contemplated by the
regulation, which states only that the nurse shall þinitiateþ appropriate
rehabilitative and nursing
procedures. Moreover, as I have discussed above, the treatment record of Patient
# 1 does not suggest that
the patient's physician wanted anything done other than what had been ordered
for that patient.
Finally, HCFA alleges that the registered nurses employed by Petitioner failed
to coordinate the services
that Petitioner provided to Patient # 1. HCFA Ex. 4 at 45. This assertion is
a restatement, in the context of
42 C.F.R. 484.30(a), that the nurses failed to coordinate the care provided
to the patient to deal with the
patientþs grief following the suicide of the patientþs grandson-in-law.
I am not persuaded that there was a
lack of coordination of care, for the reasons that I have discussed above.
2. Patient # 3 (HCFA Ex. 6, P. Ex. 10)
HCFA asserts that, in providing care to Patient # 3, Petitioner failed to comply
with the following Medicare
participation requirements: 42 C.F.R. 484.18(a) (HCFA Ex. 4 at 16, 18) and 42
C.F.R. 484.30(a) (HCFA
Ex. 4 at 35, 38 - 40). I find that Petitioner was not deficient in providing
care to Patient # 3.
The patient was certified to be cared for by Petitioner beginning May 8, 1996
and ending July 8, 1996.
HCFA Ex. 6 at 1 - 2, P. Ex. 10 at 1 - 2. Her principal diagnosis was poisoning-cardiotonics.
Additional
diagnoses included: fracture of pubis, closed; atrial fibrillation; a urinary
tract infection; cancer of the
rectum; and senile dementia. Id.
a. 42 C.F.R. 484.18(a)
HCFA asserts that Petitioner failed to develop a plan of care with its staff
for Patient # 3 that covered all of
the patientþs pertinent diagnoses, nutritional requirements, medications
and treatments, and instructions for
timely discharge of the patient. Specifically, HCFA alleges that the plan of
care for Patient # 3 stated that
þthe patient will have adequate pain relief management.þ HCFA Ex.
4 at 18. HCFA avers that the plan of
care failed to address what would be done to achieve adequate pain relief.
Essentially, HCFA is asserting that the patientþs plan of care ought
to have specifically defined what would
constitute adequate relief of the patientþs pain and how that relief would
be attained. According to HCFA,
the plan of care did not do this. I find that, contrary to HCFAþs assertion,
the patientþs plan of care did
address the patientþs pain, both in establishing a defined goal for pain
relief and in prescribing the
measures that would be employed to attain relief.
The plan of care did not, as HCFA avers, state simply that the patient would
have adequate pain relief,
without defining what adequate pain relief meant. The physician linked the patientþs
pain relief to
increasing the patientþs mobility and to her underlying medical condition.
The precise goal stated in the
plan of care was that the patient þwill have adequate pain relief management
and activity will increase
within limits of disease process within 4wks. [four weeks].þ HCFA Ex.
6 at 1, P. Ex. 10 at 1.
Furthermore, the patientþs plan of care contained instructions to Petitionerþs
staff for addressing patientþs
pain. The patient was prescribed analgesics. The staff was instructed to make
skilled observations and
assessments of the patientþs pain, including the location, intensity and
type of pain, and the effectiveness of
pain relievers. HCFA Ex. 6 at 1 - 2, P. Ex. 10 at 1 - 2.
It is unclear what more could have been done in the patientþs plan of
care to address the pain experienced
by Patient # 3. HCFA has not explained what more it expected from Petitioner.
b. 42 C.F.R. 484.30(a)
HCFA asserts that, in providing care to Patient # 3, Petitioner failed in two
respects to comply with the
standard of participation contained in 42 C.F.R. 484.30(a). First, according
to HCFA, the registered
nurses assigned by Petitioner to provide care to the patient did not make necessary
revisions to the
patientþs plan of care to address an asserted discharge þgoalþ
of returning the patient to self-care status
when she was no longer homebound. HCFA Ex. 4 at 39. HCFA avers that the plan
of care did not define
what would be meant by self-care status, and that the registered nurses assigned
to the patient failed to
make necessary revisions to the patientþs plan of care to address the
patientþs discharge goals. Id.
It is not entirely clear what HCFA is alleging, but it appears to be saying
two things. First, HCFA seems to
be asserting that the plan of care contained a gap in that it stated a goal
of discharging the patient to self-
care status when the patient was no longer homebound, without defining what
that goal really meant.
Second, HCFA is asserting that the registered nurses were obligated to revise
the patientþs plan of care to
assure that the undefined goal was defined and met.
As I find above, the Medicare participation requirements governing a home health
agency do not impose
on nurses employed by the agency the duty to revise plans of care. On this basis
alone, I conclude that
HCFAþs assertion is without merit.
Moreover, I am not persuaded that the plan of care for Patient # 3 actually
stated as a goal that the patient
would attain a status where she would be capable of caring for her own needs.
The statement relied on by
HCFA was not asserted as a treatment goal to be attained during the period of
the patientþs certification for
home health care, but as a discharge plan. HCFA Ex. 6 at 2, P. Ex. 10 at 2.
When this discharge plan is
read in the context of the patientþs entire record, it is apparent that
neither the patientþs physician nor
Petitionerþs staff thought that the patient could attain a status where
she could care for her own needs
during the period of certification. HCFA is attempting to hold Petitioner responsible
for not meeting an
alleged goal that the patientþs physician did not set for the patient.
Aside from the many illnesses that afflicted Patient # 3, this patient was
an 89-year-old individual who
suffered from senile dementia. HCFA Ex. 6 at 1 - 2, P. Ex. 10 at 1 - 2. Patient
# 3 was oriented only to her
name. Id. Prior to Patient # 3 coming under Petitionerþs care, the patient
had been a resident in a
retirement home. I infer from the patientþs record that she was dependent
on the care of others prior to her
being certified for care by Petitioner, and that her medical condition was such
that it was extremely
unlikely, if not impossible, that she would improve during the certification
period to the point where she
was capable of caring for her own needs. There is nothing about the treatment
ordered by the patientþs
physician to suggest that the physician even contemplated the possibility that
the patient would no longer
be senile and, thus, become capable of self-care.
Petitionerþs second alleged failure to comply with the requirements of
42 C.F.R. 484.30(a), according to
HCFA, lies in an additional alleged failure of the nurses who provided care
to Patient # 3 to make
necessary revisions to the patientþs plan of care. HCFA asserts that the
registered nurses failed to make
necessary revisions to the patientþs plan of care to address what þadequateþ
relief of pain constituted, or to
define the meaning of the word þadequate.þ HCFA Ex. 4 at 39 - 40.
Again, I find no duty under 42 C.F.R. 484.30(a) for the nurses to make revisions
to a patientþs plan of
care, and, thus, I find no basis to sustain HCFAþs allegation. Furthermore,
there is nothing in the record of
care provided to Patient # 3 to suggest that revisions were needed to the patientþs
plan of care to further
define the meaning of the word þadequate.þ As I discuss above, the
patientþs physician defined what was
meant by þadequateþ relief of the patientþs pain by addressing
it in the context of improving the patientþs
mobility and in the context of the patientþs disease process. HCFA has
offered no explanation of what
more could have or should have been done to define the meaning of the word þadequateþ
as it appears in
the patientþs plan of care.
3. Patient # 5 (HCFA Ex. 7, P. Ex. 11)
I find no deficiency in the care that Petitioner provided to Patient # 5. HCFA
asserts that, in providing care
to Patient # 5, Petitioner failed to comply with the requirements of 42 C.F.R.
484.30(a). Specifically,
HCFA asserts that the patientþs plan of care contained a discharge þgoalþ
to discharge the patient, an
insulin-dependent diabetic, when the patient no longer needed insulin. HCFA
Ex. 4 at 35 - 40. According
to HCFA, the plan of care for Patient # 5 did not contain instructions designed
to achieve this asserted goal.
Id. HCFA argues that, in light of the failure of the plan of care to contain
instructions to end the patientþs
dependence on insulin, the registered nurses employed by Petitioner had a duty
to revise the plan of care in
order to write the necessary instructions. HCFA avers that the nurses failed
to discharge this alleged duty,
and, thus, Petitioner was deficient. Id.
Once again, HCFA seeks to impose a duty on Petitionerþs staff which applicable
participation standards do
not impose. As I have explained above, it would be contrary to the requirements
of the Act and regulations
for nurses, on their own initiative, to make revisions to a patientþs
plan of care. For this reason alone, I
find that Petitioner was not deficient in providing care to Patient # 5.
Moreover, I do not find that the patientþs plan of care actually stated
as a treatment goal that the patient
would no longer be dependent on insulin. The plan of care establishes that the
physician who treated the
patient contemplated that the patient would remain insulin-dependent throughout
the certification period.
HCFA Ex. 7 at 1, P. Ex. 11 at 1.
The plan of care explicitly states as a goal that the patient would receive
insulin, pursuant to the
physicianþs prescription, for a period of nine weeks, a period of time
which covered the entire period of
certification. HCFA Ex. 7 at 1, P. Ex. 11 at 1. And, although the physician
did say that the patient could
be discharged if she no longer was dependent on insulin, that statement does
not appear to express a
treatment goal that the physician directed Petitioner to work to attain.
The patientþs plan of care states as a þdischarge objectiveþ
that the patient would be discharged when the
patient no longer needed insulin or when an alternate care giver is identified
for the patient. HCFA Ex. 7 at
1, P. Ex. 11 at 1. When read in its entirety, the plan for discharging the patient
rationally envisions
discharge either under the circumstance that the patient might no longer need
insulin (highly unlikely,
given the patientþs condition and the care ordered by the patientþs
physician), or where an individual is
identified who will administer insulin to the patient. HCFA has not asserted
that Petitioner failed to assist
Patient # 5 in finding an alternate care giver.
4. Patient # 6 (HCFA Ex. 8, P. Ex. 12)
HCFA asserts that, in providing care to Patient # 6, Petitioner failed to comply
with the following
participation requirements: 42 C.F.R. 484.14(g) (HCFA Ex. 4 at 2, 6); 42 C.F.R.
484.18(a) (HCFA Ex. 4
at 16, 19 - 20); and 42 C.F.R. 484.30(a) (HCFA Ex. 4 at 35, 40). I do not find
that, in providing care to
Patient # 6, Petitioner failed to comply with any of these participation requirements.
Patient # 6 was certified to be given care by Petitioner beginning May 13,
1996 and ending July 13, 1996.
HCFA Ex. 8 at 1, P. Ex. 12 at 1. The patientþs principal diagnosis was
insulin-dependent diabetes mellitus.
The patientþs additional diagnoses included congestive heart failure and
hypertension. Id.
a. 42 C.F.R. 484.14(g)
HCFA asserts that Petitioner failed to provide the necessary liaison to assure
that the efforts of Petitionerþs
staff were coordinated to support the objectives outlined in the patientþs
plan of care. Specifically, HCFA
argues that the discharge objective for the patient was to discharge the patient
when the patient no longer
needed insulin or when an alternate care giver was identified to care for the
patient. HCFA Ex. 4 at 2, 6.
According to HCFA, the clinical record of Patient # 6 failed to show how Petitionerþs
staff would work to
attain independence from insulin. Id.
I am uncertain precisely what HCFA means by asserting that the patientþs
clinical record failed to show
how Petitionerþs staff would work to free the patient from dependence
on insulin. The clinical record
introduced into evidence by HCFA consists only of the patientþs plan of
care. HCFA Ex. 8 at 1 - 2. I do
not know whether the surveyors reviewed other records during their survey of
Petitioner.
Petitioner offered a more complete record of the care it provided to Patient
# 6. P. Ex. 12 at 1 - 28. I am
satisfied from review of that record that the patientþs physician did
not contemplate freeing the patient
from insulin dependence as a goal that could be attained during the certification
period. Id. Petitioner
cannot be held accountable for failing to provide coordination and liaison to
attain freedom from insulin
dependence, because that was not a goal that the physician charged Petitioner
with attaining.
The patientþs chief complaint was that she was unable to self-administer
insulin. P. Ex. 12 at 3. The
patient was observed to be forgetful. Id. Nursing notes show that the patient
was unable to administer
insulin to herself due to: poor vision, poor eye-hand coordination, and confusion
at times. P. Ex. 12 at 9.
The notes show also that the patient lived in a board and care facility, and
that the staff of that facility was
unable to administer insulin to the patient. Id. Finally, the notes show that
the patient was unable to find
an alternate care giver to administer insulin to her. Id.
When the patientþs plan of care is read in context with the nursesþ
observations of the patient, it is evident
that the principal goal of the treating physician was to overcome the obstacles
that existed to the patient
receiving therapeutic doses of insulin. The plan of care specifically directed
that the patient receive insulin
injections for the entire certification period, pursuant to the physicianþs
orders. HCFA Ex. 8 at 1, P. Ex. 12
at 1. There is nothing in the physicianþs orders to suggest that the physician
thought that there was any
likelihood that the patient would not need insulin injections throughout the
certification period. Id.
Given that, I do not find the discharge plan to discharge the patient when
the patient no longer needs
insulin to comprise a treatment objective in the plan of care. See HCFA Ex.
8 at 1, P. Ex. 12 at 1.
Petitioner and its staff had no duty to coordinate services to attain a goal
that did not exist.
b. 42 C.F.R. 484.18(a)
HCFA asserts that Petitioner failed to develop a plan of care with its staff
that covered all pertinent
diagnoses, nutritional requirements, medications and treatments, and instructions
for a timely discharge of
the patient. Specifically, HCFA alleges that the plan of care for Patient #
6 failed to recite instructions to
attain the discharge þgoalþ to discharge the patient when the patient
no longer needed insulin injections.
HCFA Ex. 4 at 16 - 19.
I conclude that this allegation is without merit, essentially for the same
reasons that I conclude that the
preceding allegation is without merit. I do not find that the patientþs
physician ordered Petitioner and its
staff to work to attain a goal of freeing the patient from dependence on insulin.
Petitioner cannot be found
deficient for failing to work to achieve a goal that was never stated by the
physician.
c. 42 C.F.R. 484.30(a)
HCFA asserts that there is no documentation that registered nurses who provided
care to Patient # 6 made
necessary revisions to the patientþs plan of care to assure a timely discharge
of the patient. HCFA Ex. 4 at
40. HCFA premises this assertion on its determination that the patientþs
plan of care included a goal of
freeing the patient from dependence on insulin. HCFA premises this assertion
also on its interpretation of
42 C.F.R. 484.30(a) to require a nurse assigned to a patient by a home health
agency to make such
revisions as may be necessary to the patientþs plan of care.
I have explained above why I do not find that Petitionerþs nurses had
any duty to make revisions to plans
of care. Moreover, I am not persuaded that any revisions were necessary here.
If, in fact, the patientþs
physician had sought to free the patient from dependence on insulin, then, perhaps,
additional treatments
might have been necessary for the patient. But, as I find above, the physician
never contemplated
attempting to free the patient from dependence on insulin.
5. Patient # 7 (HCFA Ex. 9, P. Ex. 13)
HCFA asserts that, in providing care to Patient # 7, Petitioner failed to comply
with the following Medicare
participation requirements: 42 C.F.R. 484.14(g) (HCFA Ex. 4 at 2, 5 - 6); 42
C.F.R. 484.18 (HCFA Ex.
4 at 12, 15); 42 C.F.R. 484.18(a) (HCFA Ex. 4 at 16 - 17); 42 C.F.R. 484.18(b)
(HCFA Ex. 4 at 21, 23 -
24); 42 C.F.R. 484.30 (HCFA Ex. 4 at 25 - 28); and 42 C.F.R. 484.30(a) (HCFA
Ex. 4 at 35 - 37, 45). I
do not find Petitioner to have been deficient in providing care to patient #
7.
Patient # 7 was certified to be cared for by Petitioner beginning May 7, 1996
and ending July 7, 1996.
HCFA Ex. 9 at 1, P. Ex. 13 at 1. The patientþs principal diagnosis was
chronic airway disease. The patient
had additional diagnoses, including hypertension, angina pectoris, and insulin-dependent
diabetes mellitus.
Id.
a. 42 C.F.R. 484.14(g)
HCFA asserts that, in providing care to this patient, Petitioner failed to
insure that the personnel who
provided services maintained liaison to insure that their efforts were coordinated
effectively and supported
the objectives outlined in the patientþs plan of care. Specifically, HCFA
alleges that the plan of care stated
as a goal that patientþs shortness of breath would diminish as a result
of activity tolerance within three to
four weeks, and that the patient would show no shortness of breath and no signs
and symptoms of
pulmonary congestion within two to three weeks. HCFA Ex. 4 at 5. HCFA asserts
that the patientþs
clinical record failed to document how Petitionerþs personnel were working
to achieve these alleged goals,
inasmuch as the patientþs congestion persisted from admission through
the last clinical note dated May 27,
1996. Id. at 5 - 6.
HCFA seems to assert that Petitioner was deficient in coordinating services
to Patient # 7 because the goal
stated in the patientþs plan of care was not attained. I am not persuaded
by that argument. As I discuss
above, at part III.B.1.b. of this decision, a finding of poor coordination of
services does not follow
necessarily from a failure to attain a goal contained in a plan of correction.
It is evident that not every
patient will respond to treatment as anticipated. Here, the evidence is that
Petitioner did everything the
physician ordered to provide care to the patient. Petitionerþs staff coordinated
its efforts in order to carry
out the physicianþs orders. There is no evidence to suggest that the patientþs
failure to improve as much as
had been hoped for was a consequence of a failure by Petitioner to deliver services
to that patient.
Nursing notes show that nurses assigned to Patient # 7 worked diligently with
the patient to achieve the
goals stated in the plan of care. On every visit to the patient, the nurse made
observations concerning the
patientþs breathing and exercise tolerance. On May 9, 1996, the nurse
discussed with the patient how to
conserve energy and to perform exercises within the patientþs limitations.
HCFA Ex. 9 at 43, P. Ex. 13 at
31. On May 11, the nurse discussed with the patient the administration of a
medication that was prescribed
to alleviate the patientþs shortness of breath. The patient was shown
procedures for deep breathing and
expectorating. HCFA Ex. 9 at 42, P. Ex. 13 at 32. On May 12, the nurse instructed
Patient # 7 in the use
of a nebulizer for the patientþs breathing problems. HCFA Ex. 9 at 41,
P. Ex. 13 at 33. On May 14, the
nurse discussed with the patient the course of the patientþs pulmonary
disease. HCFA Ex. 9 at 39, P. Ex.
13 at 36.
On May 16, the nurse worked with the patient on the patientþs breathing
techniques. HCFA Ex. 9 at 35, P.
Ex. 13 at 39. On May 18, the nurse discussed with the patient the medication
Cephalexin, an antibiotic for
respiratory tract infections. HCFA Ex. 9 at 33, P. Ex. 13 at 41. On May 20,
the nurse discussed with the
patient a cough syrup that had been prescribed by the patientþs physician.
HCFA Ex. 9 at 32, P. Ex. 13 at
42.
Furthermore, the record establishes communication, liaison, and coordination
between the nurses who
treated Patient # 7 and the patientþs physician concerning the patientþs
respiratory problems. On May 15,
1996, the nurse contacted the patientþs physician to report that the patient
had a sore throat and chest pain
when coughing. HCFA Ex. 9 at 45. The physician prescribed a cough syrup and
an antibiotic for the
patient. Id.
The record establishes that these efforts attained some degree of improvement
in the patientþs breathing
problems, if not the degree of improvement which the plan of care cited as a
goal. By May 30, 1996, the
patientþs exercise tolerance improved. P. Ex. 13 at 48. On May 8, 1996,
the patient was reported to be
short of breath after walking a distance of only five feet. HCFA Ex. 9 at 44,
P. Ex. 13 at 30. However, by
May 30, the patientþs exercise tolerance improved, albeit only slightly,
so that the patient was short of
breath after walking 15 feet. P. Ex. 13 at 48.
b. 42 C.F.R. 484.18
HCFA asserts that Petitioner failed to comply with the plan of care for treating
the breathing problems
experienced by Patient # 7. HCFA Ex. 4 at 15. In the surveyorsþ report
that allegation is made in the
context of the failure of the patient to improve as much as had been anticipated
by the plan of care. Id.
However, in its posthearing brief, HCFA asserts that Petitioner failed to follow
the plan of care for Patient
# 7 because Petitionerþs staff allegedly failed to assess the patientþs
breathing problems. HCFA
posthearing brief at 17.
Above, I have described the interventions made by Petitionerþs staff
to deal with the breathing problems
experienced by Patient # 7. Petitioner provided the patient with the treatments
and care ordered by the
patientþs physician. I find no merit in HCFAþs argument that the
staff failed to assess the patientþs
breathing problems. Virtually every nursing note contains an assessment of the
patientþs breathing
problems. HCFA Ex. 9 at 31 - 40, P. Ex. 13 at 30 - 46. These assessments include
assessments of the
patientþs exercise tolerance and of the breathing problems being experienced
by the patient at each visit.
Id.
c. 42 C.F.R. 484.18(a)
HCFA asserts that, in the case of Patient # 7, Petitioner failed in two respects
to develop a plan of care that
covered all of the patientþs needs. I am not persuaded that either of
these alleged failures to comply with
the standard of participation contained in 42 C.F.R. 484.18(a) has merit.
First, HCFA asserts that the patientþs plan of care did not address the
specific interventions that would be
employed by the nurses assigned to the patient to attain goals relative to the
patientþs blood pressure.
HCFA Ex. 4 at 16 - 17. I am at a loss to understand HCFAþs allegation,
inasmuch as the plan of care for
Patient # 7 addresses in detail the interventions that were expected of Petitionerþs
staff relevant to the
patientþs blood pressure.
The plan of care stated as a goal that the patientþs blood pressure would,
within two to three weeks, show
systolic readings of between 120 and 140 and diastolic readings of between 80
and 90. HCFA Ex. 9 at 1,
P. Ex. 13 at 1. The plan of care prescribes medications for the patient, including
blood pressure
medications, and the dosages of medications to be administered to the patient.
Id. The plan of care directs
Petitionerþs staff to make skilled observations and assessments of, among
other things, the patientþs blood
pressure. Id. Moreover, the patientþs clinical record includes a patient
care plan for skilled nursing, in
addition to the physicianþs plan of care. HCFA Ex. 9 at 22. That plan
specifically instructs the nurses to
assess the patientþs response and compliance with cardiac medications.
Id.
Second, HCFA asserts that the treatment records of Patient # 7 show that Petitionerþs
nursing staff applied
Sween Cream, an over-the-counter medication, to the patient. According to HCFA,
the patientþs plan of
care was deficient because it failed to discuss administration of Sween Cream
to the patient.
Sween Cream is an over-the-counter medication which is used to treat chapped
skin. Tr. at 742 - 743. The
treatment records of Patient # 7 establish that, after inception of the patientþs
care by Petitioner, and after
the patientþs plan of care had been written, the home health aide who
treated the patient observed some
slight redness in the patientþs skin, and, on her own volition, applied
Sween Cream to the patient. By May
30, 1996, the nurses treating the patient no longer observed any redness in
the patientþs skin. P. Ex. 13 at
48.
I find no evidence that the patientþs chafing was of such severity as
to require the intervention of a
physician (who, under relevant regulations, would have had to write the patientþs
plan of care). Given
that, I cannot comprehend how Petitioner was remiss in not including the administration
of Sween Cream
in the patientþs plan of care. Furthermore, the original plan of care
that was written for the patient would
not, in any event, have addressed the redness in the patientþs skin, inasmuch
as that was a condition that
developed after the inception of the plan of care.
d. 42 C.F.R. 484.18(b)
HCFA asserts that the patientþs physician and Petitionerþs staff
did not review the plan of care for Patient
# 7 as often as the patientþs condition required. First, HCFA notes that
on several occasions, the patientþs
blood pressure differed from the blood pressure treatment objectives established
in the patientþs plan of
care. HCFA Ex. 4 at 23. Almost without exception, these instances were instances
where the patientþs
diastolic blood pressure was below 80. Id. HCFA asserts that Petitionerþs
staff and the patientþs physician
were remiss in not reviewing the patientþs plan of care with respect to
the blood pressure readings that
were being obtained for the patient.
I am not persuaded that there existed a need to review or revise the patientþs
plan of care based on the
patientþs blood pressure readings. There is neither clinical evidence
nor credible opinion evidence of
record in this case to show that the blood pressure readings for Patient # 7
deviated from those established
as goals for the patient to the extent that the patientþs physician needed
to be consulted. To the contrary,
the credible evidence is that the patientþs blood pressure, albeit slightly
lower than what the physician
directed, was acceptable. Tr. at 1015 - 1018.
Second, HCFA asserts that the patientþs clinical record failed to document
that the physician and staff
reviewed the plan of care for Patient # 7 to address the change in the patientþs
skin condition which
necessitated application of Sween Cream to the patient. HCFA Ex. 4 at 23 - 24.
Above, I have discussed the evidence which relates to this assertion. I find
no deficiency here, because
there is no evidence that the condition of the skin of Patient # 7 ever was
of such severity as to necessitate
the involvement of the patientþs physician.
e. 42 C.F.R. 484.30
HCFA asserts that Petitioner failed to provide skilled nursing services to
Patient # 7 in accordance with the
patientþs plan of care. First, according to HCFA, Petitioner did not provide
skilled nursing services in
accordance with the patientþs plan of care to attain the goals stated
in the plan of care which addressed the
patientþs shortness of breath. HCFA Ex. 4 at 27 - 28.
Above, I have discussed the interventions that Petitionerþs staff provided,
pursuant to the patientþs plan of
care, to deal with the patientþs breathing problems. I am unpersuaded
by HCFAþs characterization of
these services as not being in accordance with the plan of care for Patient
# 7. To the contrary, the
evidence is that the nurses who provided care to Patient # 7 were diligent in
carrying out the physicianþs
instructions.
Second, according to HCFA, the nurses failed to follow instructions in the
patientþs plan of care to obtain
compliance with the patientþs dietary regime. HCFA Ex. 4 at 27 - 28. Specifically,
HCFA asserts that the
plan of care for Patient # 7 stated as a goal that, within two to three weeks
of inception of the plan, the
patient would be compliant with the dietary regime prescribed for the patient.
Id. HCFA avers that the
clinical notes for the patient failed to document that the nurses who attended
the patient addressed this
instruction. Id.
This allegation is unsupported by the record. Contrary to HCFAþs assertion,
the clinical records of Patient
# 7 contain evidence that Petitionerþs staff worked to assure that the
patient was compliant with the diet
that had been prescribed. On May 13, 1996, the nurse who visited the patient
instructed the patient to
maintain a good nutritional intake. HCFA Ex. 9 at 40, P. Ex. 13 at 34. On May
15, the skilled nurse and a
licensed vocational nurse (the home health aide) conferred, and the notes of
that conference show that one
of the goals discussed was that the patient would be able to verbalize the importance
of compliance with a
prescription diet and dietary restrictions. HCFA Ex. 9 at 38, P. Ex. 13 at 37.
On May 15, the skilled nurse
instructed the patient as to compliance with dietary restrictions. HCFA Ex.
9 at 36, P. Ex. 13 at 38.
f. 42 C.F.R. 484.30(a)
HCFA asserts that Petitioner failed in several respects to comply with the
requirements of the standard
contained in 42 C.F.R. 484.30(a). These allegations are unsupported by the evidence
in this case.
HCFA argues that, in three instances, registered nurses assigned to provide
care to Patient # 7 failed to
make necessary revisions to the patientþs plan of care. HCFA Ex. 4 at
35, 36 - 37. According to HCFA,
the nurses failed to make revisions to the patientþs plan of care to address
the changes in the patientþs skin
condition that necessitated application of Sween Cream to the patient. Id. Additionally,
according to
HCFA, the nurses failed to make necessary revisions to the patientþs plan
of care to address the patientþs
breathing problems. Id. Finally, HCFA asserts that the nurses failed to make
necessary revisions to the
patientþs plan of care to address the patientþs blood pressure problems.
Id.
These assertions fail because, as I have held above, the regulations impose
no duty on nurses to make
revisions to a plan of care that is developed by a physician. Thus, even assuming
changes to the plan of
care for Patient # 7 were warranted, it was not the obligation of nurses to
have made those changes.
Furthermore, I am not convinced from the record of this case that changes needed
to be made to the
patientþs plan of care. HCFA has not explained what was inadequate about
the treatments that were being
prescribed and administered to the patient. It is true that the patientþs
breathing problems were not
improving as quickly as the physician contemplated. But, that is not to say
that additional interventions or
treatments were warranted. HCFA has offered no evidence to prove that the patientþs
breathing problems
might have benefitted from treatments or interventions that were not ordered
for Patient # 7. As far as the
patientþs skin condition is concerned, I have held above that it did not
rise to the level of severity as to
necessitate involvement by the physician. HCFA has not offered any evidence
to show what changes were
necessary in the treatment that was being provided to address the patientþs
blood pressure.
Additionally, HCFA charges that the nurses assigned to Patient # 7 failed to
coordinate the administration
of services to the patient. HCFA Ex. 4 at 45. I am not persuaded that there
is a factual basis for this
allegation. The record establishes that, on May 15, 1996, the home health aide
reported to the nurse that
the patient was experiencing skin irritation. HCFA Ex. 9 at 57, P. Ex. 13 at
74. The nurse recorded these
findings in her notes of that same date. HCFA Ex. 9 at 36, P. Ex. 13 at 38.
Thereafter, the nurse made
observations as to the patientþs skin condition until, on May 30, 1996,
the nurse reported no redness. P.
Ex. 13 at 48. The record thus proves that the nurse and home health aide discussed
the patientþs skin
problem. The home health aide treated that problem, and the nurse reported on
the problem until it was
corrected. HCFA has not explained what more ought to have been done to address
the patientþs skin
problem.
6. Patient # 8 (HCFA Ex. 10, P. Ex. 14)
HCFA asserts that, in providing care to Patient # 8, Petitioner failed to comply
with the following Medicare
participation requirements: 42 C.F.R. 484.14(g) (HCFA Ex. 4 at 2, 4 - 5, 10);
42 C.F.R. 484.18 (HCFA
Ex. 4 at 12, 14 - 15); 42 C.F.R. 484.18(a) (HCFA Ex. 4 at 16 - 18); 42 C.F.R.
484.30 (HCFA Ex. 4 at 25
- 26, 27); and 42 C.F.R. 484.30(a) (HCFA Ex. 4 at 28, 32 - 35, 38, 42 - 43).
I do not find that, in
providing care to this patient, Petitioner was deficient in complying with Medicare
participation
requirements.
Patient # 8 was certified to be provided care by Petitioner beginning February
29, 1996 and ending April
29, 1996. HCFA Ex. 10 at 3. The patient was recertified for care by Petitioner
beginning April 29, 1996
and ending June 29, 1996. HCFA Ex. 10 at 1, P. Ex. 14 at 1. As of April 29,
1996, the patientþs principal
diagnosis was that she suffered from a urinary tract infection. Id. The patientþs
additional diagnoses
included a neurogenic bladder, pneumonia, and Alzheimerþs disease. Id.
The patient was reported to be
semicomatose, paralyzed, and suffering from contractures of her limbs. Id.
a. 42 C.F.R. 484.14(g)
HCFA asserts that Petitioner failed in two respects to assure requisite liaison
and coordination of services
to this patient.
First, according to HCFA, there was no documentation in the patientþs
treatment records to show how
Petitionerþs staff was coordinating the administration of antibiotic therapy
to the patient. HCFA Ex. 4 at 4
- 5. The gravamen of HCFAþs assertion is that an unreasonable delay occurred
between the ordering of
antibiotics by the patientþs physician and the administration of the antibiotics
to the patient.
I do not find this assertion to be supported by the evidence. The evidence
establishes that Petitionerþs staff
was diligent in attempting to obtain antibiotics for Patient # 8. The delays
that occurred were due to an
apparent failure by the patientþs care giver to follow through on a telephone
request to a pharmacist to fill
a prescription and a delay by the pharmacist in filling the prescription. There
is no evidence that lack of
communication among Petitionerþs staff contributed to the delay.
Patient # 8 had been prescribed an antibiotic, Cipro, to treat the patientþs
urinary tract infection. On May
6, 1996, the patientþs nurse contacted the patientþs treating physician
to discuss the status of the patientþs
infection. HCFA Ex. 10 at 12, P. Ex. 14 at 27. The physicianþs office
was closed, and the nurse made a
follow-up call, during which she spoke with the physician. Id. The nurse advised
the physician that the
patientþs prescription for Cipro had expired. The physician ordered a
refill of the prescription. Id. On
May 6, the nurse contacted the patientþs care giver and directed the care
giver to obtain a refill of the
prescription for Cipro. Id.
On May 10, the nurses who provided care to Patient # 8 conferred to discuss
whether the care giver was
administering antibiotics to the patient pursuant to the instructions that had
been given to the care giver.
HCFA Ex. 10 at 10, P. Ex. 14 at 29. They ascertained then that the care giver
had waited until May 8 to
contact the pharmacist to have the prescription for Cipro refilled. Id. They
discovered that the pharmacist
had been unable to verify the physicianþs order and, so, had not refilled
the prescription. Therefore, on
May 10, one of the nurses contacted the treating physician and left a message,
advising the physician of the
problem. Id. The nurses conferred again on May 13. They verified that the patient
had begun receiving
Cipro again on May 11. Id.
There is no evidence that the nurses were ineffective in providing liaison
or coordinating care to the
patient. Plainly, the nurses assigned to the patient were relying on the patientþs
care giver to contact the
patientþs pharmacist to have the patientþs prescription refilled.
That the care giver was less than adept in
accomplishing that is unquestionable. But, there is no evidence that the nurses
were acting improperly
when they reposed in the care giver the duty to have the prescription refilled,
nor is there any evidence to
show that the nurses were less than diligent in discharging their duties. Indeed,
it was a second
intervention by the nurses that resulted in the patient receiving antibiotics
after they ascertained that the
care giver had failed to get the prescription refilled.
Second, according to HCFA, the plan of care for Patient # 8 contained a discharge
þgoalþ for discharge of
the patient when the patientþs Foley catheter was discontinued. HCFA Ex.
1 at 1, P. Ex. 14 at 1. HCFA
asserts that Petitionerþs staff failed to maintain liaison in order to
attain this þgoal." Id.
I find no merit in this assertion. The plan of care for Patient # 8 did not
contemplate removal of the
patientþs Foley catheter. It makes no sense to hold Petitioner accountable
for failure to coordinate services
to attain a goal that did not exist.
It is true that the patientþs plan of care states a discharge objective,
and not a treatment goal, that the
patient will be discharged to the patientþs care giver when all treatment
goals are met and the patient no
longer needs a Foley catheter. HCFA Ex. 10 at 1, P. Ex. 14 at 1. However, it
is evident from reading this
objective in the context of the entire plan of care that the patientþs
physician did not contemplate, as a
serious treatment objective, that the patient would no longer need a Foley catheter.
This patient was comatose and paralyzed, with a neurogenic bladder. There is
no evidence in the record
that she was capable of voiding without the assistance of a catheter. Nor is
there any evidence to suggest
that the physician thought that the patientþs coma would abate or that
her paralysis would end.
Furthermore, the plan of care makes it obvious that what the physician sought
to accomplish during the
second certification period was to manage the patientþs catheter so that
the patientþs urinary pattern was
stabilized. HCFA Ex. 10 at 1, P. Ex. 14 at 1. The plan of care contains not
even a suggestion that removal
of the catheter was contemplated by the physician.
The record does show, however, that substantial liaison occurred among Petitionerþs
staff and the patientþs
physician to address the treatment goals contained in the plan of care for Patient
# 8. This included
communications concerning the attempts to treat the patientþs urinary
tract infection. For example, a urine
analysis was performed of the patientþs urine on May 20, 1996, pursuant
to the physicianþs orders that the
analysis be done. These results were faxed to the physician and provided to
the registered nurse assigned
to providing care to the patient. HCFA Ex. 10 at 7. On May 20, the registered
nurse noted that the
patientþs condition was stabilizing, and the nurse recommended to the
physician that the frequency of
nursing visits to Patient # 8 be decreased. P. Ex. 14 at 57. On May 23, the
registered nurse made a follow
up call to the physician to assure that the physician had the results of the
patientþs urine analysis. P. Ex. 14
at 58.
Third, HCFA asserts that the clinical record of Petitionerþs care of
Patient # 8 fails to show effective
interchange and reporting of patient care with respect to the þgoalþ
of removing the patientþs Foley
catheter. HCFA Ex. 4 at 10. HCFA specifically identifies a case conference of
May 17, 1996, and asserts
that the participants at the conference did not discuss this asserted treatment
þgoalþ at that time. Id.
I find this allegation to be without merit, for several reasons. The requirement
for liaison and coordination
of services contained in 42 C.F.R. 484.14(g) does not specify the precise types
of documents necessary to
memorialize the liaison or coordination of services that occurs with respect
to a patient. The requirement is
only that liaison and coordination occur and be documented. Therefore, the fact
that a particular
conference does not address an issue is not dispositive of the question of whether
liaison and coordination
of services occurred. Furthermore, as I have found above, there was no þgoalþ
to remove the patientþs
Foley catheter, so a finding of deficiency cannot be premised on the staff not
conferring about this þgoal.þ
Finally, the record of the May 17 conference shows that there was liaison and
coordination at that
conference about the treatment objectives that were stated in the patientþs
plan of care, including resolving
the patientþs urinary tract infection. HCFA Ex. 10 at 39, P. Ex. 14 at
62.
b. 42 C.F.R. 484.18
HCFA asserts that Petitioner failed to follow instructions in the plan of care
of Patient # 8 to monitor the
patientþs intake and output and to assess the odor of the patientþs
urine. HCFA Ex. 4 at 14 - 15. HCFA
bases this assertion on the alleged absence from the patientþs treatment
record of a nurseþs assessment of
intake and output or of the odor of the patientþs urine. I disagree with
HCFAþs assertion that these
assessments were not made. To the contrary, the nurse dutifully made the assessments
ordered by the
physician.
The patientþs treatment record contains an þintake and output monitorþ
recording input of milk and water
and output of urine and bowel movements, for the dates beginning April 29, 1996
and ending May 22,
1996. P. Ex. 14 at 79. The report contains assessments, both of the size and
consistency of the patientþs
bowel movements. It is evident from this exhibit that the nurse was making assessments
as to any
abnormalities in the patientþs intake and output. Id.
HCFA asserts that the nurse assigned to Patient # 8 was obligated, as part
of the duty to assess the patientþs
intake and output, to assess the patientþs skin turgor and color. HCFA
argues that the nurse failed to make
these assessments. In fact, the nursing notes for this patient contain assessments,
both of the patientþs skin
color and of the presence or absence of edema. HCFA Ex. 10 at 41 - 64, P. Ex.
14 at 64 - 77.
HCFA is simply incorrect in asserting that the nurse failed to assess the odor
of the patientþs urine. The
nurse assessed urine odor on: April 30 (HCFA Ex. 10 at 50, P. Ex. 14 at 71);
May 1 (HCFA Ex. 10 at 49,
P.Ex. 14 at 72); May 8 (HCFA Ex. 10 at 45, P. Ex. 14 at 75); May 13 (HCFA Ex.
10 at 42, P. Ex. 14 at
77); May 15 (HCFA Ex. 10 at 41); and May 20 (HCFA Ex. 10 at 38, P. Ex. 14 at
78), and, on each
occasion, recorded the urine odor as being normal.
c. 42 C.F.R. 484.18(a)
HCFA asserts that Petitioner failed to develop a plan of care for Patient #
8 that contained instructions to
meet the discharge þgoalþ of discharging the patient when the patient
no longer needed to wear a Foley
catheter. HCFA Ex. 4 at 16 - 18. I am not persuaded by this allegation because,
as I find above, the
physician who treated Patient # 8 did not envision discontinuing the patientþs
use of a Foley catheter as a
realistic treatment objective.
d. 42 C.F.R. 484.30
HCFA alleges that the nurses assigned to Patient # 8 failed to carry out instructions
in the patientþs plan of
care concerning assessment of the patientþs intake and output and the
odor of the patientþs urine. HCFA
Ex. 4 at 25 - 27. These allegations are a rehash of the allegations that HCFA
makes pursuant to 42 C.F.R.
484.18. I found the allegations made under that requirement to be without merit,
and I find them to be
without merit here, as well. The record proves that the nurses assigned to the
patient made the assessments
that the patientþs physician directed to be made.
e. 42 C.F.R. 484.30(a)
HCFA asserts that, in providing care to Patient # 8, Petitioner failed in several
respects to comply with this
participation requirement. I find none of HCFAþs allegations to be supported
by the record.
First, HCFA asserts that the nurses assigned to providing care to the patient
failed to reevaluate the
patientþs nursing needs. According to HCFA, the nurses failed to reevaluate
the patientþs needs with
respect to the efficacy of irrigating the patientþs bladder. HCFA Ex.
4 at 32 - 35. In making this
allegation, HCFA refers to an irrigation of the patientþs catheter which
a nurse assigned to the patient
performed on April 15, 1996. HCFA Ex. 10 at 66, P. Ex. 14 at 64. HCFA notes
that, on March 26, 1996,
the patientþs physician directed that the nurse perform irrigations as
needed for clogging of the catheter.
HCFA Ex. 10 at 21, P. Ex. 14 at 18. Apparently, HCFA contends that the nurse
assigned to the patient
performed the irrigation on April 15, without assessing first whether the irrigation
was needed.
In fact, the most reasonable inference that may be drawn from the treatment
records is that the nurse
performed precisely this assessment. The nurseþs note of April 15 shows
that the patient was manifesting
increased sediments in her urine. HCFA Ex. 10 at 66, P. Ex. 14 at 64. An increase
in sediments, if
sufficiently large, may cause clogging of a catheter. Tr. at 800 - 803. It is
true that the nurseþs note did
not contain the word þclogging.þ But the reasonable inference is
that the nurse assessed the character of
the patientþs urine, found increased sediments, made a judgment that the
catheter either was clogged or
would soon be clogged, and performed an irrigation based on that assessment.
That is what the
participation requirement calls for and is consistent with what the physician
ordered the nurse to do.
HCFA seems also to be asserting that the nurses assigned to Patient # 8 failed
to make a requisite
assessment as to whether continued use of a Foley catheter by the patient was
medically appropriate.
HCFA Ex. 4 at 32 - 33. I am not persuaded that the nurses had any duty to make
such an assessment. The
patientþs physician explicitly ordered that the patient wear the catheter
throughout the patientþs
certification period. HCFA Ex. 10 at 1, P. Ex. 14 at 1. There is nothing in
the record to suggest that the
physician ever reconsidered this order or asked the nurses assigned to the patient
to advise as to whether
the order should be modified. I do not find that a nurse has a duty under the
participation requirement
stated in 42 C.F.R. 484.30(a) to make an assessment as to the propriety of a
physicianþs order. Moreover,
there is no evidence in the record of this case to show that any nurse, including
the nurses assigned to
Patient # 8, would be qualified to make such an assessment.
Next, HCFA asserts that the nurses assigned to Patient # 8 failed to make necessary
revisions to the
patientþs plan of care to address instructions for timely discharge of
the patient. HCFA Ex. 4 at 38. As I
have discussed above, the participation requirement in 42 C.F.R. 484.30(a) imposes
no duty on a nurse to
revise a plan of care that has been written by a physician.
Finally, HCFA alleges that the nurses assigned to Patient # 8 failed to initiate
appropriate preventive and
rehabilitative nursing procedures with regard to the patientþs use of
a Foley catheter. HCFA Ex. 4 at 42.
Although HCFA does not assert what preventive and rehabilitative nursing procedures
are lacking in the
care provided to Patient # 8, it is apparent from the allegations made by HCFA
that, once again, HCFA is
arguing that the nurses assigned to the patient ought to have made a determination
as to whether the patient
needed the catheter. I am not persuaded that the participation requirement imposes
this duty on the nurses,
where, as in this case, there is an explicit physicianþs order that the
patient wear a catheter. Nor is there
persuasive evidence that making such a determination is within the professional
skill and training of nurses.
7. Patient # 10 (HCFA Ex. 11, P.Ex. 15)
HCFA alleges that, in providing care to Patient # 10, Petitioner failed to
comply with the following
Medicare participation requirements: 42 C.F.R. 484.18(a) (HCFA Ex. 4 at 16,
20); and 42 C.F.R.
484.30(a) (HCFA Ex. 4 at 35, 37 - 38). I find that Petitioner did not fail to
comply with these participation
requirements in providing care to Patient # 10.
Patient # 10 was recertified for care from Petitioner beginning April 20, 1996
and ending June 20, 1996.
HCFA Ex. 11 at 1, P. Ex. 15 at 1. The patientþs principal diagnosis was
abnormal loss of weight. The
patient had additional diagnoses, including: malnutrition to a moderate degree,
an open wound to her arm
and knee, and rheumatoid arthritis. Id.
a. 42 C.F.R. 484.18(a)
HCFA asserts that the patientþs plan of care did not provide instructions
for a timely discharge of the
patient. HCFA Ex. 4 at 20. However, the record proves otherwise. It is evident
from the plan of care that
the physician thought that the patient would be a candidate for discharge at
the end of the period of
certification if the patient's treatment goals were met. HCFA Ex. 11 at 1 -
2, P. Ex. 15 at 1 - 2.
The plan of care contained explicit instructions for treating the patient with
timetables for establishing
treatment goals. The patient was ordered to receive adequate nutrition in order
to gain between five and
ten pounds within nine weeks. HCFA Ex. 11 at 1 - 2, P. Ex. 15 at 1 - 2. Nutrition
was ordered to be
administered through a gastrostomy tube during this period of time. Id. The
plan of care contemplated that
the patientþs wounds would heal without complications within two to four
weeks. Id.
b. 42 C.F.R. 484.30(a)
HCFA asserts that the nurses who treated the patient failed to make necessary
revisions to the patientþs
plan of care to provide instructions for timely discharge of the patient. HCFA
Ex. 4 at 37 - 38. Again, I
find that the standard imposed no duty on the nurses to revise the patientþs
plan of care. Furthermore, I am
not persuaded that any revisions were necessary. As I find above, the patientþs
plan of care contained
comprehensive treatment instructions intended to make the patient ready for
discharge.
8. Patient # 11 (HCFA Ex. 12, P. Ex. 16)
HCFA asserts that, in providing care to Patient # 11, Petitioner failed to
comply with the following
participation requirements: 42 C.F.R. 484.14(a) (HCFA Ex. 4 at 16, 20) and 42
C.F.R. 484.30(a)
(HCFA Ex. 4 at 35, 40 - 41). I do not find that Petitioner failed to comply
with these requirements.
Patient # 11 was certified to be cared for by Petitioner beginning April 23,
1996, and ending June 23, 1996
(HCFA Ex. 12, at 1, P. Ex. 16 at 1). The patientþs principal diagnosis
was transcerebral ischemia. Id. The
patient had recently undergone angioplasty and was recovering from that procedure
at the time of her
certification to receive care from Petitioner. Id. The patient was discharged
from Petitionerþs care on May
28, 1996 (HCFA Ex. 12 at 3, P. Ex. 16 at 37).
a. 42 C.F.R. 484.14(a)
HCFA asserts that Petitioner failed to comply with this requirement because
the patientþs discharge plan
failed to contain instructions for timely discharge of the patient. HCFA Ex.
4 at 20. In fact, the plan of
care contained instructions to make the patient eligible for discharge, and
the patient was discharged based
on the patient meeting the parameters set by the plan of care.
The plan of care contained a treatment goal that the patientþs cardiac
status would remain stable, without
signs or symptoms of complications, within two to three weeks. HCFA Ex. 12 at
1, P. Ex. 16 at 1. It
stated as an additional goal that the patientþs groin wound would heal
within two weeks. Id. The plan of
care stated, as a discharge objective, that the patient would be discharged
when the patient no longer
needed skilled care. HCFA Ex. 12 at 2, P. Ex. 16 at 2. It is evident from this
plan of care that the patientþs
physician assumed that the patient would no longer need skilled care when the
treatment goals of the plan
of care were met. Therefore, contrary to HCFAþs allegation, the patientþs
plan of care explicitly stated
what was necessary in order to discharge the patient.
In fact, the record proves that Patient # 11 was discharged when the patient
met the treatment goals in the
plan of care. On May 28, 1996, the nurse reported to the patientþs physician
that the patient was stable for
discharge, that the patientþs angioplasty site was clean and dry, and
that no signs of infection were
observed. P. Ex. 16 at 16. The physician ordered the patient to be discharged,
based on that report. Id.
b. 42 C.F.R. 484.30(a)
HCFA alleges that the registered nurses who treated Patient # 11 failed to
make necessary revisions to the
patientþs plan of care to address the goal of a timely discharge of the
patient. HCFA Ex. 4 at 40 - 41. As I
have held repeatedly, the standard does not impose a duty on nurses to revise
a plan of care created by a
physician. Moreover, as I discuss above, there is no evidence here that the
plan of care that the physician
wrote was inadequate or incomplete.
9. Patient # 12 (HCFA Ex. 13, P. Ex. 17)
HCFA alleges that, in providing care to Patient # 12, Petitioner failed to
comply with the following
Medicare participation requirements: 42 C.F.R. 484.14(g) (HCFA Ex. 4 at 2 -
4, 9 - 10); 42 C.F.R.
484.18 (HCFA Ex. 4 at 12 - 14); 42 C.F.R. 484.18(a) (HCFA Ex. 4 at 16, 17, 19);
42 C.F.R. 484.18(b)
(HCFA Ex. 4 at 21 - 24); 42 C.F.R. 484.30 (HCFA Ex. 4 at 26 - 27); and 42 C.F.R.
484.30(a) (HCFA
Ex. 4 at 28 - 29, 35, 38, 41, 43). I find that, in three respects, Petitioner
failed to comply with Medicare
participation requirements in providing care to Patient # 12. Petitioner failed
to comply with a
participation requirement stated in 42 C.F.R. 484.18. Petitioner failed also
to comply with a participation
requirement stated in 42 C.F.R. 484.18(b). Additionally, Petitioner failed to
comply with a participation
requirement stated in 42 C.F.R. 484.30. I find that Petitioner did not fail
to comply with other Medicare
participation requirements in providing care to Patient # 12.
Patient # 12 was first cared for by Petitioner beginning March 22, 1996. HCFA
Ex. 13 at 1, P. Ex. 17 at 1.
The patientþs initial certification period ended on May 22, 1996. Id.
The patient was recertified to receive
care from Petitioner beginning on May 22, 1996 and ending on July 22, 1996.
HCFA Ex. 13 at 3. For
each period of certification, the patientþs principal diagnosis was insulin-dependent
diabetes mellitus.
HCFA Ex. 13 at 1, 3.
A principal problem that Petitioner encountered in attempting to provide care
to Patient # 12 was the
inability to find an alternate care giver for the patient, to assume responsibility
for testing the patientþs
blood sugar and to administer insulin to the patient. The nurses who treated
the patient encountered
resistance from the individual who had agreed to serve as the care giver, both
in the administering of blood
sugar tests, and in the preparation and administering of insulin to the patient.
HCFA Ex. 13 at 36 - 123.
The patientþs treatment was complicated also by the patientþs unwillingness
or inability to test her own
blood sugar or to self-administer insulin. Id.
a. 42 C.F.R. 484.14(g)
HCFA asserts that Petitioner failed in several respects to provide liaison
or to coordinate the care being
provided to Patient # 12 to support the objectives outlined in the patientþs
plan of care. Specifically,
HCFA alleges that, during the certification period which ended on May 22, 1996,
Petitionerþs staff failed
to maintain liaison or to coordinate services to achieve the following goals
stated in the patientþs plan of
care: (1) that the patient would be able to demonstrate foods from an exchange
list; (2) that the patient or
the patientþs care giver received or completed instruction concerning
accurate use of a glucometer; and (3)
that the patientþs care giver learn how to accurately and safely administer
insulin to the patient.
Additionally, HCFA asserts that the patientþs plan of care stated a þgoalþ
that the patient would be
discharged when the patient no longer needed insulin. HCFA contends that Petitionerþs
staff failed to
document how they would insure that this þgoalþ would be attained.
Finally, HCFA alleges that the
clinical record of Patient # 12 fails to establish that Petitionerþs staff
provided liaison or coordination of
services concerning the care that they provided for the patientþs fungal
infection.
HCFA asserts that Petitioner and its staff are responsible for something over
which Petitioner had no
control -- the possible inability of the patient to learn, despite diligent
attempts to teach her, and the refusal
of the care giver to cooperate with Petitionerþs staff -- and, from that,
to conclude that Petitioner did not do
what the standard required it to do. That is not reasonable. The reasonable
way to measure Petitionerþs
compliance with the standard is to examine its efforts to comply. By that measure,
the efforts that are
documented in the patientþs treatment records prove that Petitioner complied
fully.
The patientþs plan of care contained treatment goals which included training
the patient or the care giver
to: demonstrate food from an exchange list; use a glucometer accurately; and
accurately and safely
administer insulin. HCFA Ex. 13 at 1, P. Ex. 17 at 1. These goals were transmitted
to the nurses who
cared for Patient # 12. The nurses worked diligently to achieve them.
The nurses who visited Patient # 12 instructed the patient concerning the appropriate
foods in the patientþs
diet and how to plan meals, on at least the following occasions: April 5 (HCFA
Ex. 13 at 111); April 9
(HCFA Ex. 13 at 109); April 13 (HCFA Ex. 13 at 100 - 101); April 14 (HCFA Ex.
13 at 99); April 19
(HCFA Ex. 13 at 88); April 21 (HCFA Ex. 13 at 84 - 85); April 23 (HCFA Ex. 13
at 81); April 24 (HCFA
Ex. 13 at 77 - 78); April 26 (HCFA Ex. 13 at 73 - 74); April 27 (HCFA Ex. 13
at 71); and April 28 (HCFA
Ex. 13 at 70). It is unclear from the record how well the patient learned the
dietary restrictions and
exchanges that the nurses attempted to teach her. On nearly each occasion, the
nurse recorded
verbalizations by the patient which showed that the patient was able to at least
repeat back to the nurse
some of the instructions that the nurse had given. Id.
The nurses also gave the patient and the care giver instruction concerning
the use of the glucometer.
Specific instruction was provided on April 23, 1996. HCFA Ex. 13 at 123. On
several occasions, the
nurse observed the care giver performing blood sugar testing of the patient.
These instances included:
March 28 (HCFA Ex. 13 at 119); March 29 (HCFA Ex. 13 at 118); March 30 (HCFA
Ex. 13 at 117);
March 31 (HCFA Ex. 13 at 116); April 1 (HCFA Ex. 13 at 115); and April 2 (HCFA
Ex. 13 at 114). After
April 2, the care giver was either unwilling to perform blood testing or was
absent, and the nurses
performed the blood testing.
The nurseþs notes show also that the nurses attempted to teach the care
giver to administer insulin to the
patient. However, the care giver was either unwilling to administer insulin
or not present at the time of
visits. Thus, the nurses had no choice other than to administer insulin to the
patient. See P. Reply Brief,
attachment 2.
I do not find that Petitioner failed to utilize liaison and to coordinate services
to attain a þgoalþ of
discharging the patient when the patient no longer needed insulin, as HCFA alleges.
A close reading of the
patientþs plan of care establishes that the physician did not establish
a treatment goal of weaning the
patient off insulin. In fact, the treatments prescribed by the physician were
intended to assure that the
patient and the patientþs care giver were able to administer insulin.
HCFA Ex. 13 at 1 - 2, P. Ex. 17 at 1 -
2.
I do not find an absence of liaison or coordination of services among Petitionerþs
staff in dealing with the
patientþs fungal infection. The record establishes that the patientþs
physician and the nurses who treated
the patient coordinated their services to assure that the fungal infection was
treated. The patientþs records
do not contain a physicianþs record of a diagnosis of the patientþs
fungal infection, nor do they contain an
order from the physician that medication be given to the patient to treat the
infection. See HCFA Ex. 13, P.
Ex. 17. However, I infer that the physician diagnosed an infection in early
April 1996 because, on April 3,
1996, the nurseþs note records an instruction to apply a fungicide, Spectazole.
P. Ex. 17 at 47. The nurse
gave further instructions the following day. Id. at 48. Thus, the physicianþs
order was executed by the
nurse. There is nothing in the record to suggest that additional coordination
of services was necessary to
treat the patientþs fungus infection. 10/
b. 42 C.F.R. 484.18
HCFA asserts that, in providing care to Patient # 12, Petitioner failed in
three respects to provide care to
the patient which followed directions in the patientþs plan of care. I
agree with HCFA that, in one respect,
Petitioner failed to comply with the directions in the patientþs plan
of care. I do not agree that Petitioner
failed to comply in other respects.
The patientþs plan of care for the initial period of certification (March
22 - May 22, 1996) directed
Petitionerþs staff to assess the patientþs: disease process and
progression, fluid and dietary regimen, insulin
preparation, and foot care. Additionally, the plan of care directed Petitionerþs
staff to instruct the patient
as to blood sugar testing, travel restrictions, and alteration of insulin integrity.
HCFA Ex. 13 at 1, P. Ex. 17
at 1. HCFA asserts, generally, that Petitioner failed to comply with the instructions
in the plan of care.
I have discussed above many of the interventions performed by Petitionerþs
staff. I conclude that, contrary
to HCFAþs assertions of a general failure by Petitionerþs staff
to carry out the instructions in the plan of
care of Patient # 12, Petitionerþs staff was generally diligent in carrying
out those instructions.
However, in one respect, Petitionerþs staff failed to carry out all of
the physicianþs orders. The physician
who treated Patient # 12 directed that Petitionerþs staff assess the progress
of the patientþs disease. Patient
# 12 complained consistently of blurred vision, a sign of complications of diabetes.
However, the record is
devoid of any assessment by the staff as to the extent of the problem, whether
it was becoming worse, or
even whether it was related to the patientþs diabetes.
Petitioner argues that the patientþs blurred vision may have been due
to the effects of recent cataract
surgery. It is certainly possible that the cause of the patientþs vision
problems were unrelated to her
diabetes. However, the fact that the problems might be due to diabetes was ample
reason for the staff to
have assessed them.
HCFA asserts also that Petitionerþs staff was deficient in carrying out
the instructions in the plan of care in
not assessing the patientþs fungus infection, as part of assessing the
progress of the patientþs disease. I
find that the staff did make the requisite assessments. The nursing record of
Patient # 12 shows that the
nurses who cared for the patient assessed the condition of the patientþs
skin at every visit. HCFA Ex. 13 at
36 - 123. On May 21, 1996, a registered nurse evaluated the patientþs
condition and reported the infection
to be þclearing.þ HCFA Ex. 13 at 44, P. Ex. 17 at 89. HCFA asserts
that the assessments that were made
of the patientþs skin condition were not detailed. However, they plainly
addressed the appearance of the
patientþs skin and noted the improvement in the fungus infection.
c. 42 C.F.R. 484.18(a)
HCFA asserts that Petitionerþs staff failed in two respects to develop
a plan of care that addressed all of the
patientþs problems and thus failed to comply with the standard contained
in 42 C.F.R. 484.18(a). These
allegations are not supported by the evidence.
First, according to HCFA, the plan of care developed in March 1996 had a discharge
þgoalþ to discharge
the patient when the patient no longer needed to receive insulin or when an
alternate care giver was
identified. HCFA asserts that the plan of care failed to contain instructions
as to how to wean the patient
off insulin.
This allegation does not have merit, because it is evident from the plan of
care that the patientþs physician
did not view getting the patient off insulin to be a realistic treatment objective.
Petitioner cannot be held
accountable for failing to assist in developing a mechanism to achieve a nonexistent
goal.
Second, HCFA asserts that the plan of care developed in March did not contain
instructions to treat the
patientþs fungus infection. That literally, is true. However, it is evident
from the treatment records of
Patient # 12 that the fungus infection was first diagnosed in early April 1996,
after the creation of the
March 1996 plan of care. Petitioner cannot be held accountable for not anticipating
a diagnosis that was
made after the inception of the plan of care.
d. 42 C.F.R. 484.18(b)
HCFA alleges that Petitioner failed to comply with this standard of participation
in that it failed to revise
the plan of care for Patient # 12 to address the fungus infection in the patientþs
toes. HCFA Ex. 4 at 22 -
23. Here, I agree that Petitioner was deficient.
It is unclear from the patientþs treatment records when, or precisely
how, the fungus infection was first
diagnosed. The first reference to the infection appears in a nurseþs note
dated April 3, 1996. P. Ex. 17 at
47. On that date, the nurse records that Spectazole, a fungicide, was being
administered to the patient, and
that the patientþs care giver was instructed as to how to administer the
medication. It is reasonable to infer
that, shortly prior to that date, the patientþs physician diagnosed the
fungus infection and prescribed the
medication. But, there is nothing in the treatment records of Patient # 12 that
memorializes either the
diagnosis or the physicianþs treatment plan.
I find that the failure to memorialize the physicianþs diagnosis of a
fungus infection and the physicianþs
treatment plan for the infection is a deficiency. The regulation requires that
a plan of care be revised as
often as the patientþs condition warrants. Patient # 12 had developed
a potentially serious infection,
warranting a revision to her plan of care. The regulation does not prescribe
a format for revising a plan of
care. However, the record of Patient # 12 ought to have contained at least an
order by the patientþs
physician which recorded the physicianþs diagnosis and treatment plan
for the fungus infection.
HCFA asserts also that a second deficiency exists under 42 C.F.R. 484.18(b),
in that Petitionerþs staff
failed to discharge their responsibility in not notifying the physician of Patient
# 12 of a change in the
patientþs condition (the development of a fungus infection) warranting
a revision to the patientþs plan of
care. HCFA Ex. 4 at 24. I am not persuaded that Petitioner is deficient here.
The record does not suggest
that Petitionerþs staff first identified the fungus infection. To the
contrary, the reasonable inference is that
the infection was first diagnosed by the patientþs physician.
e. 42 C.F.R. 484.30
I find that, in one respect, Petitioner failed to comply with the requirements
of 42 C.F.R. 484.30 in
providing care to Patient # 12. HCFA Ex. 4 at 26 - 27. The failure of the nurses
assigned to Patient # 12 to
assess the patientþs complaints of blurred vision, as an aspect of the
patientþs diabetes mellitus, is a failure
by the nurses to carry out their duties under the patientþs plan of care.
My finding of a deficiency under 42 C.F.R. 484.30 is based on the identical
evidence which leads me to
conclude that Petitioner was deficient under 42 C.F.R. 484.18, in providing
care to Patient # 12. The
requirement of 42 C.F.R. 484.18, that care follow a written plan of care, is
virtually restated by the
requirement in 42 C.F.R. 484.30 that the nurse follow a plan of care. Thus,
a deficiency under one
regulation must inevitably be a deficiency under the other regulation as well,
where the deficiency consists
of a nurse failing to carry out a physicianþs orders.
f. 42 C.F.R. 484.30(a)
HCFA asserts that Petitioner failed in several respects to comply with this
participation requirement in
providing care to Patient # 12. I am not persuaded that Petitioner failed to
comply with this requirement.
First, HCFA asserts that Petitioner failed to reevaluate regularly the nursing
needs of Patient # 12, in that
the nurses who treated the patient failed to document any assessment of the
condition of the patientþs toes
after the onset of the patientþs fungal infection. HCFA Ex. 4 at 28 -
29. I find this assertion to be
contradicted by the record, which I have discussed above. The nursesþ
notes show that the nurses routinely
evaluated the appearance of the patientþs skin (which I infer would have
included an evaluation of the
appearance of the patientþs toes). The status of the patientþs fungus
infection was addressed specifically
when the patient was evaluated for recertification.
Second, HCFA asserts that the nurses assigned to Patient # 12 failed to assess
the effects of their instruction
to the patientþs care giver on the care giverþs performance of blood
sugar testing, drawing insulin, and
administering insulin to the patient. HCFA Ex. 4 at 38. This assertion is contradicted
by the evidence.
The nursesþ notes show that the care giver repeatedly refused to administer
insulin or was not present at the
time of the nursesþ visits to the patient. There is nothing in the record
to suggest that any þassessmentþ
was needed, beyond recording that the care giver would not cooperate.
Third, HCFA asserts that the nurses assigned to Patient # 12 failed to reevaluate
the need to identify an
additional care giver to the patient. This assertion also is contradicted by
the evidence. The patientþs
treatment records establish that, on May 21, 1996, Petitionerþs staff
discussed the need to obtain an
alternate care giver for the patient. HCFA Ex. 13 at 44, P. Ex. 17 at 89.
Fourth, HCFA asserts that the registered nurses assigned to Patient # 12 failed
to make necessary revisions
to the patientþs plan of care to address the patientþs fungal infection.
HCFA Ex. 4 at 41. Above, I find
that Petitioner was deficient in not assuring that the patientþs plan
of care was revised by the patientþs
physician to indicate the physicianþs diagnosis of a fungus infection,
and the treatment that the physician
prescribed for that infection. However, as I have found repeatedly in this decision,
the duty to make any
revisions in a plan of care may not be allocated to the nurses who are assigned
to treat a patient.
Fifth, HCFA asserts that the registered nurses assigned to Patient # 12 failed
to make necessary revisions to
the patientþs plan of care to include instructions to wean the patient
off insulin. Again, I find that the
nurses were under no obligation to make these revisions, assuming them to have
been necessary.
Moreover, I do not find that such revisions were necessary, in that the physician
who treated Patient # 12
never stated a goal to end the patientþs dependence on insulin.
Finally, HCFA asserts that the registered nurses assigned to Patient # 12 failed
to initiate appropriate
preventive and rehabilitative nursing procedures to address the lack of cooperation
of the patientþs care
giver. HCFA Ex. 4 at 43. I am not persuaded that there was any failure of responsibility
here. The fact is,
that the care giver was uncooperative. HCFA has not suggested what þpreventive
and rehabilitativeþ
procedures might be implemented to deal with a care giver who refuses to do
what is needed to provide
care to a patient. See P. Reply brief, attachment 2. The record establishes
that, eventually, Petitionerþs
staff gave up on trying to educate the patientþs care giver and began
to search for an alternate care giver. I
can envision no action more appropriate than what was eventually done by Petitionerþs
staff.
10. Patient # 13 (HCFA Ex. 14, P. Ex. 18)
HCFA asserts that, in providing care to Patient # 13, Petitioner failed to
comply with the following
Medicare participation requirements: 42 C.F.R. 484.14(g) (HCFA Ex. 4 at 2, 6
- 7, 8 - 9); 42 C.F.R.
484.18(a) (HCFA Ex. 4 at 16, 17); and 42 C.F.R. 484.30(a) (HCFA Ex. 4 at 41,
44). I do not find that
Petitioner failed to comply with these participation requirements in providing
care to Patient # 13.
Patient # 13 was certified to be cared for by Petitioner from March 18, 1996
through May 18, 1996. HCFA
Ex. 14 at 3 - 4, P. Ex. 18 at 3 - 4. The patient was recertified to be cared
for by Petitioner from May 18,
1996 through July 18, 1996. HCFA Ex. 14 at 1 - 2, P. Ex. 18 at 1 - 2. In each
certification, the patientþs
principal diagnosis was insulin-dependent diabetes mellitus. The patientþs
other diagnoses included:
hypertension, peripheral vascular disease, osteoarthritis, and contact dermatitis.
a. 42 C.F.R. 484.14(g)
HCFA asserts that Petitioner failed in two respects to comply with this participation
requirement in
providing care to Patient # 13. First, HCFA asserts that Petitionerþs
staff failed to provide liaison and
coordination in attempting to meet a discharge þgoalþ to discharge
the patient when the patient no longer
needed insulin. HCFA Ex. 4 at 6 - 7.
I am not persuaded that either the first or the second plan of care for Patient
# 13 actually had as a
treatment goal the ending of the patientþs dependence on insulin. Patient
# 13 had been a diabetic for 10
years. P. Ex. 18 at 10. The physicianþs orders, memorialized in the patientþs
plans of care, focused on the
objective of stabilizing the patientþs blood sugar through the
regulation of insulin administered to the patient. For example, in the May 18
- July 18 plan of care, the
specific treatment order is that the skilled nurse would check the patientþs
blood sugar twice daily and
administer insulin on each visit. HCFA Ex. 14 at 1, P. Ex. 18 at 1. The skilled
nurse was instructed to
notify the patientþs physician if the patientþs blood sugar exceeded
350 mg/dl. Id. There were no orders
in the plan of care suggesting that the physician sought to wean the patient
off insulin. Thus, the discharge
objective, which HCFA defines as a þgoal,þ to discharge the patient
when the patient no longer needed
insulin or when an alternate care giver was identified, cannot be characterized
as a treatment objective by
the patientþs physician to end the patientþs dependence on insulin.
Second, HCFA asserts that a case conference held on May 17, 1996 failed to
address findings made by a
social worker concerning attempts to locate an alternate care giver for the
patient. According to HCFA,
this is proof of an absence of liaison and coordination of care. HCFA Ex. 4
at 8 - 9. I disagree with
HCFAþs conclusion. While it may be that a social workerþs report
was not discussed on May 17, the
record of the care provided to Patient # 13 shows that there was considerable
liaison and coordination
among Petitionerþs staff, and between Petitionerþs staff and others
to attempt to find an alternate care giver
for Patient # 13. As I hold above, the test for liaison and coordination of
services is not whether a subject
is discussed at a particular meeting, but whether liaison and coordination actually
occurs.
The record shows that a registered nurse assigned to provide care to the patient
received the social
workerþs report on May 15, 1996. P. Ex. 18 at 80. The report states, among
other things, that the patient
was unwilling to accept an alternate care giver. Id. Notwithstanding, the social
worker made contacts with
outside agencies in an attempt to locate an alternate care giver for the patient.
Id. On May 16, the nurse
reported to her supervisor the communication that the nurse had received from
the social worker. P. Ex. 18
at 83. The nurse related that the social worker would continue to look for other
alternatives to the care
relationship that the patient had at that time and would refer the patient to
community resources. Id. The
social worker followed up her May, 1996 visit with a second visit in June, 1996,
which was given to the
registered nurse and to the social workerþs supervisor. P. Ex. 18 at 82.
b. 42 C.F.R. 484.18(a)
HCFA avers that Petitioner failed to develop a plan of care for Patient # 13
that covered all of the patientþs
pertinent diagnoses, nutritional requirements, medications and treatments, and
instructions for timely
discharge of the patient. Specifically, HCFA asserts that the patientþs
plan of care contained a discharge
þgoalþ to discharge the patient when the patient no longer needed
insulin. HCFA Ex. 4 at 17. According
to HCFA, the plan of care failed to include instructions to Petitionerþs
staff to end the patientþs
dependence on insulin.
I am unpersuaded by this assertion. As I discuss above, the patientþs
treatment records show plainly that
the patientþs physician never contemplated that, as a reasonable treatment
objective, this patient could be
weaned off insulin.
c. 42 C.F.R. 484.30(a)
HCFA argues that the nurses assigned to the patient failed to initiate appropriate
preventive and
rehabilitative nursing procedures for the patient. Specifically, HCFA asserts
that the nurses were remiss in
not initiating procedures to cause the patient to lose weight. HCFA Ex. 4 at
44.
I do not find this allegation to have merit. The physician who treated Patient
# 13 did not specifically
identify the patientþs obesity as a condition needing treatment. See HCFA
Ex. 14 at 1 - 4, P. Ex. 18 at 1 -
4. I am not persuaded that, under the applicable participation requirement,
the nurses should have
instituted treatment for obesity in the absence of an order from the physician
to do so. The physician did
prescribe an ADA diet to the patient. Id. Possibly, this diet may have been
prescribed in an attempt to
address the patientþs obesity, or to control her blood sugar, or both.
The patientþs records establish that the
nurses assigned to Patient # 13 instructed the patient concerning her diet.
HCFA Ex. 14 at 34, 41, 56.
Thus, the nurses carried out the physicianþs orders by attempting to induce
the patient to become compliant
with an ADA diet.
11. Patient # 15 (HCFA Ex. 15, P. Ex. 19)
HCFA alleges that, in providing care to Patient # 15, Petitioner failed to
comply with the following
Medicare participation requirements: 42 C.F.R. 484.18(a) (HCFA Ex. 4 at 16,
20); and 42 C.F.R.
484.30(a) (HCFA Ex. 4 at 35, 41). I find no failure by Petitioner, in caring
for Patient # 15, to comply with
Medicare participation requirements.
Patient # 15 was certified to be cared for by Petitioner from May 16, 1996
through July 16, 1996. HCFA
Ex. 15 at 1, P. Ex. 19 at 1. The patientþs principal diagnosis was insulin-dependent
diabetes mellitus. The
patientþs other diagnoses included hypertension, chronic renal failure,
a fracture of the patientþs left arm,
and chronic obstructive airway disease. Id.
a. 42 C.F.R. 484.18(a)
HCFA asserts that the patientþs plan of care contained a treatment goal
to discharge the patient when the
patient was no longer dependent on insulin, or when an alternate care giver
was identified. HCFA asserts
that the plan of care failed to contain instructions for timely discharge of
Patient # 15. HCFA Ex. 4 at 20.
Specifically, HCFA asserts that the plan of care fails to explain how Petitioner
and the patientþs physician
intended to end the patientþs dependence on insulin.
I am not persuaded that the failure of this patientþs plan of care to
explain how the patientþs insulin
dependence would end is a deficiency. It is obvious from a dispassionate reading
of the plan that the
patientþs physician did not contemplate that it was reasonably possible
to end this patientþs dependence on
insulin.
As is the case with many of the other patients whose care is at issue here,
I am not persuaded by the
treatment record of Patient # 15 that the physician who treated the patient
contemplated ending the
patientþs dependence on insulin as a treatment goal which could be attained.
The plan of care does
mention discharging the patient when the patient is no longer dependent on insulin
or when an alternate
care giver is identified. However, the plan of care plainly does not contemplate
the likelihood that the
patient might be weaned off insulin. In fact, the plan of care focuses on stabilizing
the patientþs blood
sugar through the administration of insulin to the patient. HCFA Ex. 15 at 1
- 2, P. Ex. 19 at 1 - 2.
b. 42 C.F.R. 484.30(a)
HCFA asserts that Petitioner was deficient, because the registered nurses assigned
to Patient # 15 failed to
make necessary revisions to the patientþs plan of care to address the
þgoalþ of a timely discharge of the
patient. HCFA Ex. 4 at 41. As I hold above, the Medicare participation requirements
which govern home
health agencies do not assign to nurses the duty to revise plans of care. Nor,
as I explain above, do I find
the absence of instructions in this patientþs plan of care addressing
the þgoalþ of discharging the patient
when the patient no longer depended on insulin, to be a deficiency.
D. HCFAþs allegations that Petitioner failed to conduct requisite management
reviews (Finding
10)
HCFA alleges that Petitioner failed to conduct the management reviews and assessments
required under 42
C.F.R. 484.52 and 484.52(a). The overwhelming evidence is that Petitioner dutifully
conducted the
requisite reviews and assessments. P. Ex. 21, 22, 30.
HCFA bases its assertion that Petitioner failed to comply with the requirements
of 42 C.F.R. 484.52 and
484.52(a), on the testimony of Mr. Raymond A. Montgomery, one of the surveyors
who participated in the
survey which ended on May 30, 1996,. Tr. at 389 - 424. Mr. Montgomery testified
that he failed to see
any documentation that Petitioner was addressing the requirements contained
in the regulation. Tr. at 393 -
396.
Mr. Montgomeryþs testimony does not establish precisely which documents
he reviewed at the survey
ending on May 30, 1996. It is evident, however, that, whether or not Mr. Montgomery
reviewed all of
Petitionerþs records, Petitioner performed the kind of self-evaluation
and assessment that the regulation
required. Indeed, Petitioner did what Mr. Montgomery testified he expected that
Petitioner would have
done. See Tr. at 393 - 396.
Pursuant to 42 C.F.R. 484.52, a home health agency must conduct an overall
evaluation of its program at
least annually. Such evaluation must be performed by professional personnel,
the agencyþs staff, and
consumers, or by professional personnel from outside the agency working in conjunction
with the agency.
The evaluation must consist of an overall policy and administrative review and
a review of clinical records.
The evaluation must assess the extent to which the home health agencyþs
program is appropriate, adequate,
effective, and efficient. The report and results of the evaluation must be acted
on by those who are
responsible for operating the agency. The standard contained in 42 C.F.R. 484.52(a)
requires that, as part
of the evaluation, the policies and administrative practices of a home health
agency are reviewed to
determine the extent to which they promote patient care that is appropriate,
adequate, effective, and
efficient.
Petitioner satisfied all of these requirements. It held an annual management
review on May 9, 1996. P.
Ex. 22. The management review of May 9, 1996 comprised a comprehensive evaluation
by Petitioner of
its overall program. It identified problems which might affect adversely the
appropriateness, adequacy,
effectiveness, and efficiency of the care that Petitioner gave to its patients.
It proposed solutions to these
problems. Subsequently, these proposals were adopted by Petitionerþs Board
of Directors.
The participants at the May 9 review included management representatives consisting
of Petitionerþs
President, Corporate Administrator, Director of Nursing, Clinical Supervisors
and branch management. P.
Ex. 22 at 361. The participants included professional personnel, including nurses
and physicians. Id. A
consumer representative was present at the meeting. Id.
The review included a review of the Petitionerþs policies and procedures.
These included a total quality
management system, a performance system with four components intended to assure
that Petitioner
complied with quality of care requirements. P. Ex. 22 at 361 - 362. The review
included also a review of
Petitionerþs costs and expenditures, including a review of overpayments
to be repaid to the Medicare
program. Id. at 364. The review included a review of the charts of discharged
patients. Among other
things, this review focused on whether patients who were recertified ought to
have been recertified, and
whether individual cases were managed properly. Id. The review included a review
of the charts of active
patients. This review addressed thirteen specific problem areas having to do
with Petitionerþs care of
patients. P. Ex. 22 at 367.
Petitionerþs management review consisted of more than a review of records.
Specific proposals were
discussed and adopted to address those problems which were identified. P. Ex.
22 at 361 - 367.
On May 30, 1996, Petitionerþs Board of Directors held a special meeting.
P. Ex. 30. At that meeting, the
Board of Directors adopted the recommendations resulting from Petitionerþs
May 9, 1996 management
review. Id.
E. HCFAþs allegations that Petitioner failed to comply with conditions
of participation (Findings
11 - 14)
The record does not support HCFAþs assertion that Petitioner failed to
comply with the condition of
participation contained in 42 C.F.R. 484.14. In part, HCFA premised its assertion
that Petitioner failed to
comply with this on allegations that, in a number of instances, Petitioner had
not provided necessary liaison
and coordination of services. I have reviewed each of HCFAþs allegations
of alleged failure to provide
liaison and coordination of services at Part III.C. of this decision, and I
find them to be without merit.
HCFA premised its allegation that Petitionerþs governing body failed
to exercise the degree of control
required under section 484.14 on HCFAþs assertion that Petitioner had
failed to comply systematically
with Medicare participation requirements. I find this assertion to be without
merit, because there is no
evidence that Petitioner failed to comply systematically with Medicare participation
requirements.
I am not persuaded that Petitioner failed to comply with the condition of participation
contained in 42
C.F.R. 484.18, the condition governing the creation and revision of plans of
care. According to HCFA,
Petitioner manifested a pattern of failures to comply with the requirements
of the condition. HCFA asserts
that this alleged pattern of failures to comply is proof that Petitioner failed
to comply with the condition.
There is persuasive evidence that in two instances involving Patient # 12, Petitioner
failed to comply with
the requirements of 42 C.F.R. 484.18. Petitioner failed to assure that the patientþs
plan of care was
revised to report a physicianþs diagnosis of the patientþs fungus
infection, and plan of treatment for the
infection. Petitioner failed also to assure that the nurses assigned to Patient
# 12 assessed the patientþs
complaints of blurred vision, which, arguably, might have been related to the
patientþs diabetes mellitus.
I do not find that the two instances of failures to comply with requirements
contained in 42 C.F.R. 484.18
is evidence of a pattern of failures to comply with these requirements, as is
alleged by HCFA. Nor do I
find that these two failures to comply show that Petitioner is incapable of
complying with participation
requirements. I am not downplaying the significance of Petitionerþs failure
to comply with participation
requirements in providing care to Patient # 12. However, it is apparent from
the total record of this case
that these examples of failures to comply are isolated incidents which do not,
in and of themselves,
establish Petitioner to be incapable of providing care of the quality required
under the Act and regulations.
I do not find that Petitioner failed to comply with the requirements of 42
C.F.R. 484.30, the condition of
participation governing nursesþ performance of their duties. As with 42
C.F.R. 484.14, HCFA asserts
that Petitioner manifested a pattern of failures to comply with the requirements
of 42 C.F.R. 484.30. The
evidence establishes one failure by Petitioner to comply with participation
requirements stated in 42 C.F.R.
484.30. The nurses assigned to provide care to Patient # 12 failed to assess
the patientþs complaints of
blurred vision as a possible sign of diabetes. However, that is the only instance
in which I find a failure by
Petitioner to comply with the requirements of the regulation. As with the two
instances of failures to
comply with the requirements of 42 C.F.R. 484.18, this instance is neither proof
of a pattern of failures to
comply with the regulation nor is it proof that Petitioner is incapable of providing
care required under the
Act and regulations.
Finally, I do not agree with HCFAþs assertion that Petitioner failed
to comply with the self-evaluation
requirements of 42 C.F.R. 484.52. As I hold at Part III.D. of this decision,
the overwhelming evidence is
that Petitioner complied with this condition.
F. Petitionerþs motion that I waive the requirement that it pay its
share of transcript costs
(Finding 15)
Prior to the hearing, I advised the parties that, pursuant to the requirements
of 42 C.F.R. 498.15, each of
them would be assessed one-third the cost of the transcript of the hearing.
I advised them that I would
waive a partyþs share of the costs, only on a showing of good cause by
that party.
After the hearing, Petitioner moved that I waive its share of the cost of the
transcript. HCFA opposed the
motion. I conclude, after reviewing Petitionerþs motion, that there is
no good cause for me to waive its
share of the cost of the transcript.
Petitioner accompanied its motion with a declaration by Mariano Velez, Petitionerþs
sole owner and chief
financial officer. P. Ex. 32. 11/ In his declaration, Mr. Velez asserts that
Petitioner received no payments
for Medicare reimbursement after July 15, 1996. Id. Mr. Velez asserts also that
Petitioner has had to
expend an enormous sum of money to defend itself against HCFAþs actions.
Id. Mr. Velez asserts that,
based on these factors, Petitioner is without resources to pay for its share
of the transcript cost.
The regulation which governs transcript costs does not specify what is good
cause to waive a partyþs
requirement to pay its share of the cost of a transcript. I find that financial
destitution, if proven by a party,
is good cause. Here, however, I am not satisfied that Petitioner proved that
it is destitute. Mr Velezþ
assertion that Petitioner is without resources is not a persuasive statement
that Petitioner lacks the
wherewithal to pay for its share of the cost of the transcript. It is merely
a conclusion, without actual proof
of lack of resources.
IV. Conclusion
I am not persuaded by HCFAþs allegations or by the evidence of record
in this case that Petitioner failed to
comply with a condition of participation in Medicare. I conclude that HCFA did
not have a basis to
terminate Petitionerþs participation in Medicare.
________________________
Steven T. Kessel
Administrative Law Judge
1. I assigned to HCFA the burden of proving its assertions by a preponderance
of the evidence. HCFA
failed to meet its burden. However, I would find in favor of Petitioner even
had I assigned the burden of
persuasion to Petitioner. The preponderance of the evidence is that Petitioner
complied with all of the
conditions of participation that are at issue in this case.
2. In July 1995, the Part 488 regulations were revised and amended substantially
as they apply to long-
term care facilities, including nursing facilities and skilled nursing facilities.
42 C.F.R. 488.301 et seq.
The revisions and amendments are not at issue in this case because Petitioner
is not a nursing facility or a
skilled nursing facility.
3. The criteria which govern the circumstances under which HCFA may impose
a remedy, including
termination, against a nursing facility or a skilled nursing facility are stated
at 42 C.F.R. 488.402 -
488.456.
4. At first, HCFA determined to terminate Petitionerþs participation
effective July 12, 1996. HCFA Ex.
3 at 1. However, Petitioner sought an injunction against termination, and the
termination was delayed until
July 25, 1996.
5. HCFA did not designate this memorandum as an exhibit. In order to assure
that the record of this case
is complete, I have designated the memorandum as HCFA Ex. 23, and I am receiving
it into evidence.
6. The declaration contains two þexhibitsþ (Exhibits A and B).
In order to assure that the record of this
case is complete, I am designating the declaration and the two exhibits as a
single exhibit, P. Ex. 31, and I
am receiving it into evidence.
7. Also, I excluded an exhibit offered by Petitioner which is an affidavit
by a lawyer who purports to be
an expert in health care law and who offered his opinion as to the meaning of
some of the relevant
regulations. P. Ex. 3. I invited the parties to argue the meaning of the regulations
in their post-hearing
briefs and to supply me with any appropriate legislative history or other extrinsic
material that would aid
me in deciding the meaning of regulations, to the extent that I found any of
them to be ambiguous. Tr. at
1063 - 1065. HCFA did not avail itself of that opportunity, either in its posthearing
brief or in its reply
brief.
8. The relevant treatment records, by patient are as follows: Patient # 1 --
HCFA Ex. 5, P. Ex. 9; Patient
# 3 -- HCFA Ex. 6, P. Ex. 10; Patient # 5 -- HCFA Ex. 7, P. Ex. 11; Patient
# 6 -- HCFA Ex. 8, P. Ex. 12;
Patient # 7 -- HCFA Ex. 9, P. Ex. 13; Patient # 8 -- HCFA Ex. 10, P. Ex. 14;
Patient # 10 -- HCFA Ex. 11,
P. Ex. 15; Patient # 11 -- HCFA Ex. 12, P. Ex. 16; Patient # 12 -- HCFA Ex.
13, P. Ex. 17; Patient # 13 --
HCFA Ex. 14, P. Ex. 18; Patient # 15 -- HCFA Ex. 15, P. Ex. 19.
9. Furthermore, I am not convinced from the record of this case that a nurse
would be qualified to make
such an assessment. HCFA did not offer persuasive evidence to establish that
the training and professional
experience of a registered nurse would qualify the nurse to make such an assessment.
10. However, as I discuss below, Petitioner should have assured that the patientþs
treatment record
contained an amendment to the patientþs plan of care to document the physicianþs
diagnosis of a fungus
infection and to document the treatment plan for that infection.
11. Petitioner did not designate this declaration by Mr. Velez as an exhibit.
However, I have designated
it as P. Ex. 32 and have admitted it into evidence. I have also designated as
HCFA Ex. 26 and admitted
into evidence the declaration of Ruth L. Beaird and attachments to the declaration,
which HCFA submitted
in opposition to Petitionerþs motion to waive Petitionerþs share
of the cost of the transcript.