Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
|
IN THE CASE OF | |
VITAS Healthcare Corporation of California, |
DATE: February 16, 2001 |
- v - |
|
Health Care Financing Administration.
|
Docket No.C-99-733
Decision No. CR738 |
DECISION | |
I decide that the Health Care Financing Administration
(HCFA) did not have the authority to terminate the Medicare provider agreement
of Petitioner, VITAS Healthcare Corporation of California (the hospice).
At the hearing, HCFA failed to establish a prima facie case that it had
the authority to terminate, effective August 10, 1999, the hospice's Medicare
provider agreement. Consequently, the hospice's motion to overturn the termination
is granted. I. PROCEDURAL HISTORY The hospice is located in Torrance, California. HCFA terminated
the hospice's Medicare provider agreement, effective August 10, 1999.
By letter and brief dated August 9, 1999, the hospice challenged the termination
and requested an expedited hearing. The case was assigned to me for a
hearing and a decision. I held an in-person hearing in Los Angeles, California
from December 13 - 17, 1999, and from December 20 - 22, 1999. At the hearing, I admitted exhibits from each party into
evidence. From HCFA, I admitted into evidence exhibits which are identified
as HCFA Ex. 1 - HCFA Ex. 4, HCFA Ex. 4A, HCFA Ex. 5 - HCFA Ex. 23, and
HCFA Ex. 40 - HCFA Ex. 43. (I did not admit HCFA Ex. 24 - HCFA Ex. 39.
I also did not admit HCFA Ex. 44 (Tr. 1480), and I did not take a copy
of HCFA Ex. 44 for the record.) From the hospice, I admitted into evidence
exhibits which are identified as P. Ex. 1 - P. Ex. 6, P. Ex. 7 (except
for P. Ex. 7, p.7A, which I did not admit, Tr. 2142), P. Ex. 8 - P. Ex.
22, and P. Ex. 24 - P. Ex. 38. In this Decision, I refer to the transcript
of the hearing as Tr. HCFA completed its case-in-chief on the sixth day of the
hearing, December 20, 1999. Tr. 1803. I limited HCFA's presentation to
evidence relevant to the final survey in June 1999. After HCFA rested,
the hospice moved to have the termination overturned, because HCFA had
failed to demonstrate a prima facie case of violation of the regulations
such that termination would be appropriate. Tr. 1803. I stated that I
would take the hospice's motion under advisement. Tr. 1805. The hospice resumed the presentation of its case-in-chief.
(Over HCFA's objection, I had permitted the hospice to call three witnesses
out of order during the midst of HCFA's presentation of its case-in-chief.)
On December 22, 1999, over HCFA's objections (Tr. 2384 - 2385, 2387 -
2391, 2395 - 2396), I recessed the hearing so that I could consider the
hospice's motion to overturn the termination, as well as its motion concerning
whether HCFA had provided it with adequate notice of alleged deficiencies.
I informed the parties that, in ruling on whether HCFA had established
a prima facie case to support its termination, I would consider only the
evidence presented in HCFA's case-in-chief; that is, the evidence that
was elicited through HCFA's witnesses, including the cross-examination
of them. I would not consider the testimony elicited through witnesses
called by the hospice. Tr. 2386, 2396 - 2398, 2470. Thus, throughout this
Decision, when I refer to the evidence, I am referring to only the evidence
presented in HCFA's case-in-chief. In February, March, and April 2000, the parties submitted
briefs. In this Decision, I refer to the hospice's opening brief as P.
Br. I refer to HCFA's brief as HCFA Br. I refer to the hospice's reply
brief as P. R. Br. Each brief has attachments, which I do not admit into
evidence. Neither party requested that any of its attachments be admitted
into evidence; the attachments to the briefs have been accepted merely
as part of the party's argument, and not as evidence. The additional evidence that HCFA wished to present as
part of its case-in-chief was from the March 1999 revisit survey. See
Tr. 18. Both prior to the hearing and during the hearing, I informed the
parties that I would not take any evidence pertaining to the March 1999
survey during the December 1999 hearing, but I reserved ruling as to whether
I would receive the March 1999 survey evidence at
a later time. Tr. 34 - 36. As I explain below in section V.D., I have
concluded that the March 1999 survey evidence is irrelevant. I now summarize the history of the 1999 surveys, followed
by a summary of my rulings and order prior to this Decision. The first of three surveys was completed on January 7,
1999, when surveyors from HCFA and the California Department of Health
Services (State health agency) conducted a recertification/complaint survey
of the hospice. The purpose of the survey was to determine whether the
hospice was complying with the requirements of the Medicare program. The
State health agency notified the hospice by letter that, based on the
survey, it had determined that the hospice was out of compliance with
12 Medicare conditions of participation. The hospice was also provided
with the HCFA Form 2567 -- Statement of Deficiencies (SOD), which listed
all the alleged deficiencies found during the January 7, 1999 survey.
The hospice was advised that it had the opportunity to take prompt corrective
action. In response, the hospice submitted its credible allegation of
correction. To verify the hospice's representation that full corrective
action had been taken, HCFA authorized an extended resurvey of the hospice.
That resurvey was completed on March 4, 1999. As a result of that survey,
HCFA notified the hospice by letter dated March 26, 1999 (HCFA Br., Attachment
B), that it had determined that the hospice was out of compliance with
six conditions of participation, and additionally, there were other deficiencies
which remained uncorrected from the January 7, 1999 survey. HCFA advised
the hospice that HCFA would terminate the hospice's participation in Medicare
effective April 15, 1999. In response to the SOD which listed all the
alleged deficiencies found during the March 4, 1999 survey, the hospice
submitted its credible allegation of correction on May 25, 1999, alleging
completion of correction by May 15, 1999 (HCFA Br., Attachment A). Subsequent to HCFA's March 26, 1999 notice letter, HCFA
made what HCFA characterizes as "a determination under the very unusual
and uncommon circumstances" of the hospice's case (HCFA Ex. 2 at 2) to
exercise its discretion not to effectuate the termination as noticed in
its March 26, 1999 letter, pending a second resurvey of the hospice. The second resurvey (3rd survey) of the hospice
was conducted by a survey team of two HCFA surveyors and two State health
agency surveyors and was completed on June 23, 1999. The surveyors found
that the hospice was out of compliance with two conditions of participation,
Governing Body, 42 C.F.R. � 418.52, and Plan of Care, 42 C.F.R. �
418.58. By letter dated July 22, 1999, HCFA notified the hospice that,
because it was not in compliance with all conditions of participation
at 42 C.F.R. Part 418 as determined during the June 23, 1999 survey, HCFA
would terminate the hospice's Medicare provider agreement effective August
10, 1999. HCFA Ex. 2 at 2. HCFA's notice letter stated further that the
June 23, 1999 resurvey also documented that the hospice had failed to
correct deficiencies identified during the prior March 4, 1999 survey,
and that several of these deficiencies had also been identified during
the January 7, 1999 survey. HCFA advised the hospice that these repeat
deficiencies established a separate and distinct basis for termination
under the terms of 42 C.F.R. �� 488.28 and 489.53(a)(1). Id. at
2. On January 18, 2000, I issued a ruling, entitled "Ruling
on the Health Care Financing Administration's Request for Clarification,
and Order Setting Briefing Schedule." Among other things, I reiterated
that, in ruling on the hospice's above-mentioned motions (concerning overturning
the termination, including the issue of adequate notice of alleged deficiencies),
I would consider only the evidence presented by HCFA's witnesses during
HCFA's case-in-chief, including both direct and cross-examination of HCFA's
witnesses, plus all exhibits pertinent to direct and cross-examination
of HCFA's witnesses. I also informed the parties that they were requested,
but not required, to file briefs. I gave the parties briefing deadlines. On January 31, 2000, I ruled on HCFA's Request for Reconsideration.
In the Ruling, I stated, among other things, that I was declining to revise
the deadlines contained in my January 18, 2000 Order. I also again overruled
HCFA's renewed objections to my proceeding to rule on the issues of whether
HCFA established a prima facie case, and whether HCFA provided the hospice
with adequate notice. By Order dated February 8, 2000, I granted HCFA's request
for an extension of time to file its responsive brief, and extended the
hospice's time to file its reply brief. I also requested the parties to
identify one week in June or July 2000 to reconvene the hearing, should
that prove necessary. On June 5, 2000, I ruled, as follows:
Ruling That HCFA Failed to Establish a Prima Facie Case
That It Had the Authority to Terminate, Effective August 10, 1999, Petitioner's
Medicare Agreement, dated June 5, 2000. My Ruling stated further that I was giving the provider
the opportunity to decide whether it wished to present the remainder of
its case-in-chief, in whole or in part, at the in-person evidentiary hearing
that was scheduled to reconvene on June 12, 2000. My intention was to
permit the provider to choose whether to present its remaining testimony
at that time, before I issued a decision, or to wait, because further
testimony might not be necessary. I held a telephone conference with the parties on June
8, 2000. During the conference, counsel for the hospice requested that
the hearing be continued until they had received a complete written ruling
from me. The hospice's counsel also stated that it would like to submit
a declaration, agreed upon by HCFA, stating that the hospice was reserving
the right to present the remainder of its case-in-chief in the event my
ruling, in whole or in part, is overturned by the Appellate Division of
the Departmental Appeals Board (DAB) on appeal. HCFA counsel agreed to
consider language to this effect submitted by counsel for the hospice,
but questioned whether the hospice's attempt to reserve its right to present
further evidence was legally binding, since it would be the Appellate
Division who would have the authority to determine the further course
of proceedings after issuing its decision on appeal. I informed the parties
that I would permit the hospice to submit such a declaration, which would
be entered into the record. Accordingly, I canceled the reconvening of
the hearing. The hospice was unable to obtain HCFA's agreement as to
the language of the hospice's proposed declaration. As a result, the hospice,
on its own, filed a Declaration dated June 14, 2000, regarding the reservation
of its right to present the remainder of its case-in-chief in the event
my ruling is overturned or modified, in whole or in part, by the Appellate
Division of the DAB. As discussed above, this Decision is based on only the
evidence presented by HCFA's witnesses, including both direct and cross-examination
of HCFA's witnesses, plus all exhibits pertinent to direct and cross-examination
of HCFA's witnesses, without consideration of the evidence presented by
the hospice's witnesses who did testify before I recessed the hearing.
This Decision further details the Ruling I issued on June 5, 2000. II. APPLICABLE LAW This case involves a hospice. A hospice is a Medicare
provider described under section 1861(dd)(1) of the Social Security Act
(Act), which offers care, items, and services to a terminally ill individual.
42 U.S.C. � 1395x(dd)(1). Under the Medicare program, an individual is
considered to be "terminally ill" if the individual has a medical prognosis
that he or she is expected to live six months or less. Act, section 1861(dd)(3)(A);
42 U.S.C. � 1395x(dd)(3)(A). The central purpose of hospice care is to provide dying
individuals with palliative care, including the management of discomfort
and symptom relief (42 C.F.R. � 418.58(c)), rather than curative care.
A terminally ill individual has the option to choose hospice care as an
alternative to traditional care. Pursuant to section 1864(a) of the Act, the Secretary
of the United States Department of Health and Human Services (Secretary),
entered into agreements with State health agencies to survey hospices
for compliance with Medicare conditions of participation and to report
their findings to HCFA. HCFA acts as the delegate of the Secretary. 42
U.S.C. � 1395aa(a); 42 C.F.R. �� 488.10 and 488.11. The Secretary may
terminate a hospice's Medicare provider agreement after the Secretary
finds that the hospice is not complying substantially with Medicare conditions
of participation. Act, section 1866(b)(2); 42 U.S.C. � 1395cc(b)(2); 42
C.F.R. �� 488.24, 488.26, 488.28, and 489.53(a)(1). The conditions of participation for a hospice are found
in the regulations at 42 C.F.R. �� 418.50 - 418.100.
HCFA is authorized to terminate a hospice's Medicare provider agreement
where the hospice has failed to comply with a condition of participation.
A hospice has failed to comply with a condition of participation where
the deficiencies, either individually or in combination, are "of such
character as to substantially limit the provider's . . . capacity to furnish
adequate care or which adversely affect the health and safety of patients
. . . ." 42 C.F.R. � 488.24(b). Likewise, HCFA determines that a hospice
with deficiencies may continue to participate in Medicare only when the
existing deficiencies, either individually or in
combination, neither jeopardize the health and safety of patients nor
are of such character as to seriously limit the hospice's capacity to
render adequate care. 42 C.F.R. � 488.28. In determining whether a hospice is compliant with a particular
condition of participation, the surveyors evaluate the manner and degree
to which the hospice satisfies the various standards within each condition.
42 C.F.R. �� 418.50 - 418.100, and 488.26(b). A hospice standard-level
deficiency is a failure to provide the care and services that meet the
needs of the hospice patients as required by a hospice standard. 42 C.F.R.
� 488.26. HCFA bears the burden of coming forward with evidence sufficient to establish a prima facie case that a provider was not in substantial compliance with a condition of participation; or that the existing deficiencies, either individually or in combination, were "of such character as to substantially limit the provider's . . . capacity to furnish adequate care or which adversely affect the health and safety of patients . . . ." 42 C.F.R. � 488.24(b). See Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States Department of Health and Human Services, Health Care Financing Administration, No. 98-3789 (D.N.J. May 13, 1999). III. ISSUEThe issue is whether HCFA had the authority to terminate, effective August 10, 1999, the hospice's Medicare provider agreement. IV. FINDINGS OF FACT AND CONCLUSIONS OF LAW (FFCLs)
V. DISCUSSION
The hospice's alleged noncompliance with the
condition found at 42 C.F.R. � 418.58 (Tag L132) HCFA alleged that in June 1999, the hospice had a condition-level
deficiency in meeting the Plan of Care requirements (the hospice's alleged
noncompliance with Tag L132). The Plan of Care requirements are found
in the regulations at 42 C.F.R. � 418.58 (Condition of participation --
Plan of care).
HCFA based the condition-level deficiency (Tag L132) on
the hospice's alleged noncompliance with Tags L133, L135, L136, and L137. The hospice's alleged noncompliance with the
standard found at 42 C.F.R. � 418.58 (Tag L133) In the SOD, under Tag L133, HCFA alleges the violation of 42 C.F.R. � 418.58 at the standard level, citing the regulatory language stated above. HCFA states that "[a] review of 9 of 9 clinical records revealed the identified plan of care was vague and non-specific. The identified goals for a problem had interventions that were not related to the goal." HCFA Ex. 1 at 8. Following these allegations is a recitation of the situations concerning six of the hospice's patients: Patients 7, 3, 2, 4, 8, and 9. Id. at 8 - 13. Before discussing HCFA's alleged findings, I must first
address the issue of whether HCFA provided the hospice with adequate notice
in the SOD of its findings relating to this Tag. In its hearing request,
and again in its initial post-hearing brief, the hospice asserted that
while the SOD alleges that 9 clinical records had been found to be deficient,
HCFA had set forth specific findings for only 6 patients, and had failed
to provide the hospice sufficient notice in the SOD of the findings regarding
the other three patients for it to respond adequately. For this reason,
the hospice argued that I should not consider any findings concerning
the three other patients' records. I find that the hospice has raised a valid notice issue regarding the allegations under Tag L133. Although the surveyors stated in the SOD that nine clinical records, and therefore, nine patients, were reviewed under this particular Tag, the SOD then goes on to recite specific allegations relating to only six patients. HCFA could have identified the other three patients whose records were reviewed and provided the hospice with this information prior to the hearing. HCFA chose not to do so. Because it did not, I will consider only the allegations relating to the six patients that are set forth in the SOD in determining whether they support a finding that the standard at 42 C.F.R. � 418.58 was not met.(1)
With respect to Patien 7, in the SOD, HCFA contends that
the hospice nurse failed to document that she monitored Patient 7's bowel
pattern and rectal burning at every visit as required by the patient's
Care Plan #3 for Elimination. HCFA Ex. 1 at 9 - 10. I am persuaded that the documentation with respect to
the monitoring of Patient 7's bowel pattern was not adequate in all respects.
However, as I will discuss below, this inadequacy in documentation does
not support a finding of noncompliance with the standard. With respect
to HCFA's allegation concerning monitoring of Patient 7's rectal burning,
I find that the hospice's documentation was adequate. Patient 7 had a diagnosis of amyotrophic lateral sclerosis
(ALS), commonly known as Lou Gehrig's disease. Patient 7 received hospice
care at her home. According to the medical record, Patient 7's primary
caregiver appears to have been a family member. HCFA Ex. 11 at 1. The
State health agency surveyor, Ms. Garces, testified that she visited Patient
7 at her home and interviewed her in the presence of one of the hospice
nurses who was there providing care to the patient. Tr. 397 - 398. Patient 7's Care Plan #3 for Elimination contained interventions
to monitor the patient's bowel pattern at every visit and to monitor for
rectal burning at every visit. HCFA Ex. 11 at 14. The intervention to
monitor Patient 7's bowel pattern was written in conjunction with the
hospice team goal that the "Pt. [patient] will have BMs [bowel movements]
Q [every] 3 days." Id. at 14. The intervention to monitor Patient
7's rectal burning was written in conjunction with the team goal that
the "Pt. will receive Anusol & Prep H per doctors orders to relieve
rectal burning." Id. As evidence that the nurse was monitoring Patient 7's
bowel pattern at each visit, the hospice points to the nursing notes dated
May 19, 1999, May 27, 1999, June 2, 1999, June 9, 1999, and June 16, 1999,
and states that for each of these dates, the nurse wrote "BM's [bowel
movements] per poc [plan of care]." HCFA Ex. 11 at 53, 49, 45, 40, and
35; P. Br. at 98.(2) The hospice asserts
that the surveyor conceded that this phrase ("BM's per poc") indicates
that Patient 7 had bowel movements every three days, which would be in
accordance with the care plan. P. Br. at 98; Tr. 423. The hospice contends
that the surveyor admitted that there is documented evidence that the
nurse was monitoring or assessing the patient's progress toward the goal
on the care plan. Tr. 434 - 435. The hospice argues also that each of
the nursing notes also contains the date of Patient 7's last bowel movement,
which is further indication that the patient was meeting the hospice team
goal of having bowel movements every three days. Id. Furthermore,
the hospice argues that, according to the nurse's notes, Patient 7 was
not experiencing any constipation, diarrhea, or impaction, since the nurse
had not checked off those areas in the notes. Id. Ms. Garces testified that the fact that neither the care
plan nor the nursing notes identified any bowel movement pattern indicated
that monitoring was not occurring. Tr. 408, 444; HCFA Ex. 11 at 35. Ms.
Garces stated that, as part of monitoring, the nurse should have defined
what constituted a regular bowel movement for the patient. Tr. 457. With
respect to the nurse's notes, Ms. Garces stated that the notes did not
indicate "how many days apart" the patient's bowel movements were and
that "[t]here's no way of knowing what type of bowel movements [Patient
7] was having, whether she was having diarrhea stools, whether she was
having hard bowel." Tr. 443, 433. Moreover, Ms. Garces testified also
that, while the goal was for Patient 7 to have bowel movements every three
days, nowhere in the nursing notes is it documented that the goal of having
bowel movements every three days was met. Tr. 444.(3) While I do not agree with Ms. Garces' contention that
monitoring was not occurring (the notations that were made suggest that
monitoring of Patient 7's bowel movements was occurring), I do find that
additional, specific charting with respect to Patient 7's bowel pattern
would have been helpful. I recognize that the nurse was not a witness
to the patient's bowel movements; she visited only once a week and relied
on the information she got from the patient and family members. I find
that, presumably, when the nurse wrote, "BM's [bowel movements] per poc
[plan of care]," she meant that she had been told that Patient 7's bowel
movements were occurring every three days, in accordance with the goal.
But one should not have to presume what the nursing notation means. Saying
that care is being provided "per plan of care," gives no clear indication
what care was provided and leaves a dearth of information, both for other
caregivers, and for surveyors. Despite the nurse's failure to record literally the frequency
of Patient 7's bowel movements, the date of the patient's last bowel movement
is recorded each visit. On May 19, 1999, Patient 7's last bowel movement
was shown to have been on May 17. On May 27, 1999, her last bowel movement
was shown to have been on May 26. On June 2, 1999, Patient 7's last bowel
movement was shown to have been on June 1. On June 9, 1999, her last bowel
movement was shown to have been on June 9. On June 16, 1999, Patient 7's
last bowel movement was shown to have been on June 16. HCFA Ex. 11 at
53, 49, 45, 40, and 35. Thus, the documentation shows that Patient 7 had
a bowel movement on the same day as the nurse's visit, or within one or
two days of the visit. The documentation fails to show that Patient 7's
bowel movements were occurring at least every three days. There is no dispute that Patient 7 had a care plan for
elimination. The nursing notes do contain notations or comments concerning
Patient 7's bowel movements, including the date of her last bowel movement.
What I find to be inadequate about the documentation is that "per plan
of care" is unclear, and that too little information is provided. Here,
the care to be provided was the monitoring, so that it would be clear
if interventions were needed to help the patient meet her goal. I would have liked the nursing notes to have contained
more specific documentation, e.g., a literal statement of the frequency
of Patient 7's bowel movements, and a description of what kind of bowel
movements she was having. Nevertheless, I find no deficiency under Tag
L133 regarding Patient 7's Elimination plan of care, because the omission
of detail was relatively insignificant and because there was no evidence
to show that the care provided to Patient 7 was not in accordance with
her plan of care, as required by the regulation, or that the care failed
to meet her needs. Thus, I do not find the documentation inadequacy so
significant as to support a finding that the hospice failed to comply
with the standard under Tag L133. With respect to HCFA's allegation that the hospice did
not monitor Patient 7's rectal burning at every visit, I do not agree
and find that the hospice's documentation was adequate. The nurse's notes,
as well as the surveyor's testimony, demonstrate to my satisfaction that
Patient 7's rectal burning was being monitored in accordance with the
care plan directive. In the nurse's notes, which are the focus of this allegation,
the nurse documented that Patient 7 was using the medications Prep H and
Anusol and wrote "effective for rectal burning."(4)
HCFA Ex. 11 at 35, 40, 45, 49, and 53. Although Ms. Garces testified that the hospice's nursing
notes should have stated additional information regarding Patient 7's
rectal burning, such as "the degree of rectal burning or if [the patient]
was experiencing more" (Tr. 418, see Tr. 446), I do not agree that
more documentation was necessary in order to demonstrate that the hospice
was monitoring the patient's rectal burning. The fact that each of the
nurse's notes states the medications being used, and contains the notation
"effective for rectal burning" is adequate to show that the hospice monitored
the effectiveness of the medications at each visit, and thus, was also
monitoring Patient 7's rectal burning. On cross-examination, Ms. Garces
acknowledged that it did appear that the nurse was documenting in the
nurses' notes "that the patient's rectal burning was being relieved by
those medications." Tr. 415. Ms. Garces conceded further that it "appear[ed]"
that the "nurse was on each visit assessing whether or not the patient's
rectal burning was being relieved." Tr. 415; see Tr. 417. Ms. Garces
admitted also that the patient did not complain that the medication was
ineffective and conceded that, according to the documentation, the patient's
symptom of rectal burning was controlled. Tr. 422; see Tr. 414. The goals in Patient 7's Elimination plan of care were
that she have a bowel movement every three days and that her rectal burning
be relieved. The evidence fails to prove that Patient 7 was not provided
with care and services in accordance with her Elimination plan of care.
Despite the lack of specificity in describing Patient 7's bowel movements,
there is no evidence that the hospice failed to monitor Patient 7's bowel
pattern every visit or failed to monitor for rectal burning every visit.
Based on the evidence regarding Patient 7, there is no standard-level
deficiency under Tag L133.
At the hearing and in its post-hearing response brief,
HCFA admitted that the reference to Patient 3 in Finding 1(b) on p. 10
of the SOD (HCFA Ex. 1 at 10) was a typographical error, and that Patient
7, rather than Patient 3, should have been referenced. Tr. 460; HCFA Br.
at 62. The hospice objected to any discussion of this alleged
deficiency on the grounds that it had not been given adequate notice by
HCFA as to whom this alleged deficiency was referring. The hospice asserted
that its request for hearing put HCFA on notice that it had not received
accurate notice of which patient was at issue here, but, despite being
made aware of this notice issue, HCFA never corrected or clarified the
typographical error. Tr. 461, 465 - 466; P. Br. at 99. HCFA did not deny that it had failed to provide the hospice
with any written notification to correct or clarify the typographical
error. HCFA argued, however, that the hospice should have raised this
concern in its meetings with HCFA, and also that it should have been obvious
from the format of the SOD that it was Patient 7, not Patient 3, who was
at issue. Tr. 461 - 465. I stated at the hearing that I "d[id] not find the format
of the 2567 [SOD] to be so obvious that it gives notice to [the hospice]
that the reference to Patient No. 3 meant Patient No. 7." Tr. 466. I ruled
that I would not "allow evidence as to this particular patient on this
particular tag." Tr. 468. In its brief, HCFA requests that I reconsider my ruling
denying consideration of this alleged deficiency, contending that the
remainder of the allegation in the SOD correctly identifies the patient
as Patient 7. HCFA argues that "it should have been obvious to [P]etitioner"
that Patient 7 was the patient being referenced. HCFA Br. at 62 - 63. In my decision in the Libbie Convalescent Center
case, DAB CR589 (1999), I discussed the issue of HCFA's failure to notify
the hospice, in writing, of a numbering error on the resident list.(5)
I held that:
Libbie Convalescent Center, at 11. My holding in Libbie applies to the case at hand.
HCFA had the obligation to provide the hospice with written notification
that there was a typographical error as to a resident identity in the
SOD, and that Patient 7, rather than Patient 3, should have been referenced
on p. 10 of the SOD. HCFA failed to provide the hospice with any written
correction or clarification. Accordingly, I conclude that HCFA did not
provide the hospice with adequate notice as to this alleged deficiency
under Tag L133, and I consequently eliminate this alleged deficiency from
consideration. Here, in the SOD, Patient 3 is mistakenly cited as the example, followed by a reference to Patient 7, who is the intended example. The allegations here, under Tag L133, concern certain medications that were not available in Patient 7's home, and those same allegations are thoroughly evaluated on the merits under Tag L213. See infra the discussion of Patient 7 under Tag L213. Under Tag L213, on page 30 of the SOD (HCFA Ex. 1 at 30), Patient 6 is mistakenly cited as the example in the SOD, followed by a reference to Patient 7, who is the intended example. With respect to Tag L213, I found that HCFA had provided adequate notice of the patient's identity, and that the error in the SOD was overcome by the detail contained in the same section of the SOD, where there were two references to Patient 7. Tr. 1770; HCFA Ex. 1 at 30 - 31.
Under Finding 2 of Tag L133 in the SOD, HCFA alleged,
in part, that "the problem list" in the Plan of Care Case Conference Summary
form in "nine patient records" "did not correlate with the standardized
problems on the Interdisciplinary Care Plan Problem forms" and that "[t]his
method of care planning resulted in interventions being noted for problems
for which they were not appropriate." HCFA Ex. 1 at 10 - 11. HCFA mentioned
two examples under this finding, but did not cite any specific patients
or any specific patient records. At the hearing, HCFA did not offer any evidence in support
of these allegations. HCFA also did not make any arguments in its posthearing
brief concerning this alleged deficiency. The hospice asserts that because HCFA failed to present
any evidence at the hearing relating to these allegations, this alleged
deficiency must be dismissed. P. Br. at 99 - 100. I conclude that HCFA failed to come forward with any affirmative
proof in support of the allegations under Finding 2 of Tag L133 in the
SOD. Although HCFA contends in the SOD that care plan documentation problems
were identified in "nine patient records," it failed to identify any of
those nine patients or records on which the surveyors relied as evidence
for their findings of noncompliance. The fact that HCFA's allegations
suffer from a lack of specificity constitutes a lack of notice to the
hospice. The hospice had no way of knowing what evidence to offer to rebut
HCFA's allegations. HCFA's unsubstantiated allegations and lapse in proof
mean there is no basis on which to find the presence of any deficient
behavior on the part of the hospice with respect to its care-planning
documentation.
In he case of Patient 2, HCFA contends in the SOD that
there was no documented evidence as to how the interventions of discontinuing
monthly laboratory work and providing Lopressor according to the physician's
orders related to the patient's comfort management. HCFA Ex. 1 at 11.
Additionally, HCFA stated that, according to the Food and Fluid care plan,
the hospice team goal for Patient 2 was "maintain source of nutrition
through end of life." HCFA noted that the patient received a gastrointestinal
tube feeding of Isosource HN. HCFA alleges that there was no documented
evidence as to how the interventions of checking blood sugar daily, with
regular insulin coverage, and using Compazine to treat nausea and vomiting,
related to Patient 2's maintaining a source of nutrition. Id. at
12. In attempting to prove this alleged deficiency, HCFA relies
to a large extent on the testimony of its surveyor, Commander (Cdr.) Liebmann.
Cdr. Liebmann is a registered dietician. The weight I give to Cdr. Liebmann's
testimony depends in large measure on the degree of expertise she possesses
concerning the subject area of her testimony, and on the extent to which
her statements are supported by the documentary evidence. However, I give
little weight to her opinion as to the propriety of care ordered by physicians. HCFA does not dispute that care plans were established
and maintained for Patient 2, who resided in a nursing home.(6)
See HCFA Ex. 6 at 1. Rather, HCFA appears to question the rationale
behind various interventions and their relation to a particular care plan. With respect to the interventions listed for Patient 2's
comfort management, HCFA's surveyor questioned how these interventions
would further the patient's comfort. For the reasons stated below, I find
HCFA's arguments that the discontinuation of laboratory work and using
Lopressor would not have addressed or furthered the comfort management
of Patient 2 to be flawed.(7) HCFA argues
that "there is no evidence showing why the instructions to discontinue
monthly lab work and to administer Lopressor should even have been included
in a plan of care for managing the patient's comfort." HCFA Br. at 65;
See Tr. 472 - 473. However, contrary to HCFA's contention, the
listing of these interventions on Patient 2's Comfort care plan were directly
related to Patient 2's comfort. Because laboratory testing often entails
pricking the patient's skin with a needle, which could be painful, the
discontinuation of laboratory work would contribute to a patient's comfort.
Indeed, on cross-examination, the surveyor conceded that "it's possible"
that the discontinuation of lab work and the attendant needle-pricking
would contribute to the patient's comfort. Tr. 482. With respect to Lopressor,
the surveyor testified on cross-examination that it would be important
to a patient's comfort for a patient to keep his blood pressure under
control (Tr. 500), and admitted there was no potential for harm to Patient
2 from the hospice documenting on its Comfort care plan that the patient
was on Lopressor. Tr. 501. Thus, I find also that the use of Lopressor
for Patient 2 was an appropriate and relevant intervention. I conclude also that HCFA's allegation concerning the
Food and Fluid care plan interventions for Patient 2 is without basis.
I reject HCFA's argument that the intervention of checking Patient 2's
blood sugar daily, with regular insulin coverage, would not be pertinent
to the goal of maintaining the patient's source of nutrition. Patient
2's medical conditions included diabetes, for which she was on insulin.
Tr. 471 - 473. Although Patient 2's diabetes was not related to her terminal
illness (Tr. 476), there is nothing improper to be inferred from the hospice's
monitoring and treating her diabetes. Indeed, the surveyor admitted on
cross-examination that "there is some relationship between the patient's
diabetes and maintaining nutrition." Tr. 485. The surveyor testified further
on cross-examination that "blood sugar and insulin affect how a patient
would maintain a source of nutrition." Tr. 488. Thus, it is reasonable
to conclude that the intervention of checking Patient 2's blood sugar
daily is directly related to Patient 2's maintaining a source of nutrition. In the SOD, HCFA also appears to question the intervention
in the care plan for Isosource formula. When asked to state the basis
for citing this as part of the alleged deficiency, the surveyor testified
that "It [i.e., the care plan] just states an order. It's not necessarily
an intervention how that's going to maintain nutrition through life, through
end of life." Tr. 476; HCFA Br. at 67. The surveyor testified that Patient
2's care plan (HCFA Ex. 6 at 9) was inadequate "to address the tube feeding."
Tr. 477 - 478. The surveyor stated that she would have expected the care
plan to document such things as whether the patient was tolerating the
tube feeding, whether there were any complications from the tube feeding,
whether the patient was receiving sufficient calories, whether her weight
was stable, and whether there were any side effects from the tube feeding.
Tr. 477. I am not persuaded that the intervention for Isosource inadequately
addresses or relates to the hospice team goal of maintaining a source
of nutrition for Patient 2. In fact, Patient 2's medication list states
that Isosource HN liquid was being given for her nutritional abnormalities.
HCFA Ex. 6 at 20. Moreover, I note that, in the SOD, HCFA does not explicitly
allege that the order for Isosource was problematic -- the SOD
states only that Patient 2 "received a gastrointestinal tube feeding of
Isosource HN, administered at 55 ml/hr for 22 hours." HCFA Ex 1 at 12.(8)
In any case, common sense would indicate that giving the patient tube
feedings and having a care plan intervention for Isosource, which is the
tube feeding formula, would directly relate to the maintenance of a source
of nutrition for Patient 2. There was no evidence to convince me otherwise. Moreover, whether or not Patient 2 was absorbing her Isosource feedings would depend on whether her nausea and vomiting was controlled. Thus, it is reasonable to conclude that controlling Patient 2's nausea and vomiting with Compazine would be a relevant intervention to the goal of maintaining a source of nutrition for the patient. I find that it was not a deficient practice on the part of the hospice to administer Compazine to the patient. In fact, at the hearing, the surveyor conceded that the use of Compazine was an "appropriate" intervention since "nausea and vomiting can be a result of the tube feeding," and stated further that there is "no deficiency regarding the Compazine." Tr. 478, 490 - 491. I conclude that the evidence, evaluated in accordance with 42 C.F.R. � 488.26, does not support a finding that the standard under Tag L133 was not satisfied with regard to Patient 2. There is no evidence to prove that the care provided to Patient 2 by the hospice was inadequate or that the hospice failed to meet the needs of Patient 2 in accordance with the applicable portion of 42 C.F.R. � 418.58.
In the case of Patient 4, HCFA alleges that there was
no documented evidence how the medication Risperdal was related to the
management of the patient's emotional grief and anxiety. HCFA Ex. 1 at
12.(9) For the reasons stated in the hospice's brief, I do not
find that the standard under Tag L133 was not satisfied with regard to
Patient 4. Patient 4 resided in a skilled nursing facility. See
HCFA Ex. 8 at 1. There is no dispute that an interdisciplinary plan of
care, labeled "#4 - Emotional Reaction," was established for Patient 4
to address her emotional needs. HCFA Ex. 8 at 69. According to the care
plan updates, the hospice interdisciplinary team approved the use of Risperdal
to treat Patient 4's "anxiety m/b [manifested by] kicking." Id.
at 6. The intervention to administer Risperdal was initiated on April
20, 1999, and the interdisciplinary team changed the dosage around May
28, 1999. Id. The hospice team goals are stated in the April 20,
1999 care plan updates as follows: "Pt. [patient] will remain calm [with
decreased] episodes of anxiety" and "[the hospice] will be aware of changes
in pt. mental state." Id. Cdr. Liebmann testified that Patient 4 is nonverbal, and
offered testimony that it was "hard for [her] to understand" how the hospice
was able to assess the patient's anticipatory grief or anxiety (Tr. 520;
see Tr. 522) and that the hospice should have assessed "what was
causing the anxiety." Tr. 543. Cdr. Liebmann testified that she was unable
to "see the relationship" between Risperdal and anticipatory grief and
anxiety. Tr. 520 - 521. She asserted that a deficiency existed "because
there's no clear indication as to the intervention being appropriate to
meeting the goals of the emotional reaction, anticipatory grief or anxiety."
Tr. 528 - 529. HCFA argues also that the care plan does not indicate
how the effectiveness of Risperdal in relieving the patient's grief and
anxiety would be determined. HCFA Br. at 69. HCFA contends further that
Patient 4 could be kicking for reasons other than being anxious, and points
to other information in Patient 4's medical record which indicates her
kicking could be related to a history of leg pain. Id.; see
HCFA Ex. 8 at 68. According to Cdr. Liebmann, Patient 4's medical record
does not allow one to determine whether the patient's "kicking and moaning
were from pain as opposed to being related to anxiety." Tr. 538. HCFA
thus asserts that Risperdal might not be an appropriate intervention for
the patient's kicking. HCFA Br. at 69; see Tr. 523. Although HCFA
acknowledges that the record shows that Patient 4 was experiencing agitation
as manifested by constant kicking and moaning (HCFA Ex. 8 at 23), HCFA
nevertheless asserts that "since there was never a good assessment as
to why the patient was moaning and kicking, it was an inappropriate intervention
to simply order Risperdal without knowing the root cause of any of these
symptoms." HCFA Br. at 69; see Tr. 525. I am not convinced by HCFA's arguments. Patient 4's care
plan clearly states that the Risperdal, an anti-psychotic medication,
is to be used to treat her anxiety as manifested by kicking. I find there
is nothing improper to be inferred from this. In fact, Cdr. Liebmann testified
that Risperdal could "possibly" be given for anxiety. Tr. 521 - 522. The
fact that Patient 4 is a nonverbal patient who could not have expressed
anxiety verbally does not lead to a different conclusion. Cdr. Liebmann
testified that, in a nonverbal patient, some of the expressions of anxiety
would be restlessness and agitation. Tr. 522, 529. As stated above, Patient
4's medical record shows that she was agitated, and that Risperdal was
prescribed for her "agitation m/b [manifested by] constant kicking/moaning.
Tr. 522; HCFA Ex. 8 at 23. On cross-examination, Cdr. Liebmann conceded
that it was "possible" that Patient 4's agitation could mean that she
was experiencing anxiety. Tr. 529 - 530. Cdr. Liebmann admitted that kicking
could "[p]ossibly" be a symptom of anxiety in a nonverbal patient. Tr.
532. Thus, although Patient 4 is nonverbal, it is certainly possible that
she was experiencing anxiety as manifested by her agitation, thus making
the administration of Risperdal an appropriate intervention. Moreover, I am not persuaded by HCFA's argument that because
the hospice did not determine the "root cause" of Patient 4's moaning
and kicking, it was inappropriate to order Risperdal for the patient.
By this argument, HCFA is essentially questioning the propriety of care
ordered or provided by the interdisciplinary team to Patient 4. The only
testimony offered by HCFA on this issue was that of Cdr. Liebmann, who
is a registered dietician, and not a physician. I do not find Cdr. Liebmann
to be qualified to opine as to the propriety of care given to Patient
4. It is manifest from Patient 4's medical record that the interdisciplinary
team identified that Patient 4 was experiencing anxiety and sought to
decrease her anxiety with Risperdal. Thus, absent any medical expert testimony
to the contrary, of which none was presented by HCFA, there is nothing
to suggest that the hospice's treatment of Patient 4 with Risperdal was
improper or unrelated to her anxiety. Finally, I note that although the SOD alleged that "[t]here
was no documented evidence how [Risperdal] was related to the management
of emotional grief and anxiety" (HCFA Ex. 1 at 13), on cross-examination,
Cdr. Liebmann admitted that Patient 4's care plan did not state that Risperdal
was to be used to treat her emotional grief. Tr. 535 - 536. The evidence fails to show that Patient 4 was not provided
with care in accordance with her interdisciplinary care plan for Emotional
Reaction. Based on the evidence regarding Patient 4, there is no standard-level
deficiency under Tag L133.
With respect to Patient 8, HCFA alleges in the SOD that a review of the nurses' notes from May 18, 1999 to June 15, 1999, revealed that the hospice did not have documentation for three of five visits to indicate that the skilled nurse had monitored the patient's breath sounds at every visit as stated in the plan of care. HCFA Ex. 1 at 12 - 13. Patient 8 received hospice care at home. HCFA Ex. 12 at
1. Patient 8's interdisciplinary care plan for Ventilation contains, among
other interventions, a directive dated October 8, 1998, to "monitor breathe
[sic] sounds Q [every] visit." Id. at 41. The interdisciplinary
team goal written in conjunction with the aforementioned directive stated
that the patient was "to receive DME [durable medical equipment] and medications
to relieve dyspnea." Id. Based on the testimony of the State health agency surveyor,
Ms. Poolsawat, the five nurse visits referenced in the SOD were those
performed on May 18, 1999, May 25, 1999, June 4, 1999, June 8, 1999, and
June 15, 1999. Tr. 561 - 565, 629 - 672, 678 - 681, 695 - 696, 697 - 705,
710 - 715, 729 - 733. Of these five visits, Ms. Poolsawat testified that
the nursing notes for the visits made on May 25, 1999, June 4, 1999, and
June 15, 1999, did not contain documentation that the nurse had monitored
Patient 8's breath sounds on these visits. Tr. 666. The nursing notes for May 25, 1999, indicate in the "Respiratory"
section that Patient 8 has rales and wheezes, and is taking oxygen as
needed. The nurse also wrote a zero to document that Patient 8 did not
have a cough. In the "comments" section, the nurse wrote the following:
"Pt. Denies S.O.B. [shortness of breath] - Pt. uses O2 [oxygen] regularly
PRN [as needed] - 0 cough since taking cough syrup - compliant with inhalers."
HCFA Ex. 12 at 24. Based on these notations and comments, I am satisfied
that the hospice nurse adequately monitored Patient 8's breath sounds
on this visit. It would not have been possible for the nurse to determine
that Patient 8 had rales and wheezes unless she had listened to Patient
8's lung sounds. This was not disputed by Ms. Poolsawat. Tr. 667. Moreover,
the zero which the nurse wrote next to the word "cough" adequately indicates
that Patient 8 was assessed not to have a cough. In the June 4, 1999 nursing notes, the nurse documented
in the "Respiratory" section that Patient 8 has rales, has a cough "in
a.m. only," and is taking oxygen as needed. The "comments" section states:
"Pt. Denies S.O.B. - Rales noted scattered throughout lungs fields." HCFA
Ex. 12 at 16. As with the May 25, 1999 nursing notes, I find that these
notations and comments constitute sufficient evidence to demonstrate that
the hospice nurse listened to Patient 8's lungs on this visit and, thereby,
carried out the care plan directive to monitor the patient's breath sounds.
It would not be reasonable to conclude otherwise based on the nurse's
comments that she noted rales scattered throughout Patient 8's lungs and
that he coughed only in the mornings. Ms. Poolsawat admitted that these
notes indicate that the nurse listened to Patient 8's breath sounds. Tr.
695. Thus, I am not persuaded that the nursing notes for the
May 25 and June 4, 1999 visits contained inadequate documentation regarding
the monitoring of Patient 8's breath sounds. Below, I discuss the documentation
from the remaining visit, on June 15, 1999. HCFA Ex. 12 at 9.
The hospice nurse left the boxes for rales and wheezes
unchecked in her notes for June 15, 1999. HCFA Ex. 12 at 9. Leaving the
boxes unchecked might indicate an absence of rales and wheezes. But the
hospice nurse also failed to make any notations to affirmatively indicate
that Patient 8 did not have these symptoms. The nurse affirmatively indicated
that Patient 8 did not have a cough by writing a zero next to the word
"cough." Id. It is thus unclear to me whether the nurse monitored
the patient's breath sounds for rales and wheezes on June 15, 1999. If
the nurse monitored Patient 8's breath sounds that day, in accordance
with Patient 8's care plan, and found no rales or wheezes, she could have
documented that by writing zeros next to the words "rales" and "wheezes."
This charting, therefore, contains an omission. The hospice explains the charting omission with respect
to rales and wheezes by stating that its staff follows a method of charting
known as "charting by exception."(10)
According to the hospice, under this method, a nurse would only write
down abnormal findings, and would not be required to write down normal
findings. Tr. 672, 675 - 676. Thus, the hospice argues, the fact that
nothing was written next to rales and wheezes in the nursing notes means
that the patient was not having any problems with his breath sounds. P.
Br. at 111. The hospice's explanation of "charting by exception" does
not change my analysis. As stated above, I find that the documentation
in the June 15, 1999 nursing notes is lacking with respect to the monitoring
of Patient 8's breath sounds. It is evident from the May 25, 1999 and
June 4, 1999 nursing notes that Patient 8 had rales and wheezes. If Patient
8 no longer had rales and/or wheezes on June 15, 1999, then the hospice
nurse should have affirmatively stated this in the nursing notes. In considering whether the hospice's inadequate documentation
on one day supports a finding of noncompliance with the standard under
Tag L133, I find the hospice's omission to be insignificant in the context
of the care provided to Patient 8. On cross-examination, Ms. Poolsawat
testified that she had no evidence of harm to Patient 8 as a result of
the alleged deficiency. Tr. 728. The June 15, 1999 nursing notes are one
of five nursing notes in Patient 8's medical record reviewed regarding
breath sounds. Those five nursing notes provide evidence that the hospice
did provide care and services to Patient 8 that
met his needs in accordance with his plan of care. A single question remains,
and that is whether the hospice nurse, on June 15, 1999, monitored Patient
8's breath sounds for rales and wheezes. In the June 15, 1999 nursing notes, the hospice nurse
had indicated that Patient 8's goal for that visit was, "No goal -- I'm
doing good." HCFA Ex. 12 at 9. What the hospice nurse indicated in the
respiratory section of the notes was that no new or further intervention
was required, referring to care plan #11. As previously stated, she indicated
also that he had no cough. The hospice nurse wrote that "Pt. Denies Dyspnea
currently - uses O2 [oxygen] approx. 3x per day." She made a further notation
regarding the rate and method of delivery of his oxygen. The hospice nurse
left the boxes for rales and wheezes unchecked. Id. This inadequate charting for only one day for only one
aspect of Patient 8's respiratory monitoring is insufficient for HCFA
to establish a prima facie case that the hospice failed to provide care
to Patient 8 in accordance with his plan of care. As discussed above,
out of the three nurse visits alleged by Ms. Poolsawat to have inadequate
documentation, I found the nursing notes for two of those three visits
(May 25, 1999 and June 4, 1999) to be adequate. There was no evidence
that the hospice failed to provide care that met Patient 8's needs in
accordance with his interdisciplinary care plan for Ventilation. This
insignificant documentation omission in the June 15, 1999 nursing notes
certainly does not rise to even a standard-level deficiency under Tag
L133.
With respect to Patient 9, the SOD alleges that, although
a "home health aide documented that the patient developed reddened areas
on the coccyx and perineal area"(11) and
notified the registered nurse of this finding, a review of the nurses'
notes revealed that there was no documentation "to reflect that the registered
nurse had assessed the patient's skin on [the] coccyx and perineal" areas.
The SOD goes on to contend that a care plan was not developed for the
aforementioned finding. HCFA Ex. 1 at 13. The surveyor, Ms. Poolsawat, visited Patient 9 at her home. Ms. Poolsawat described the patient as being bedridden, with her husband as the primary caregiver. Tr. 745. Patient 9 had a gastrostomy (feeding) tube. Id. Ms. Poolsawat testified that she reviewed a Home Health Aide Note dated June 14, 1999. Tr. 746. On this note, in the "comments" section, the home health aide had documented, among other things, that the patient's skin was "warm to the touch" and that there was a "reddened area on coccyx." The home health aide had also written that she had notified the registered nurse of these findings. HCFA Ex. 13 at 92. Ms. Poolsawat testified further
that she reviewed the June 14, 1999 nursing notes, and that the "skin"
section of the nursing notes stated only that the patient's percutaneous
endoscopic gastrostomy (PEG) dressing was to be changed daily, and that
her skin was "pink and moist in color." Moreover, the nurse had indicated
that no new or further interventions were required. Tr. 747 - 748; HCFA
Ex. 13 at 94. Ms. Poolsawat stated that the nursing notes did not contain
any description at all of the patient's skin around the coccyx area. Tr.
750. According to Ms. Poolsawat, the comment that the patient's skin was
"pink and moist" appears to indicate that the nurse examined the PEG area
and found only the skin around that area to be pink and moist. Id.
Ms. Poolsawat found no evidence that the nurse had examined the patient's
coccyx area or that a care plan was developed for the reddened area. Tr.
745 - 746, 748. On cross-examination, Ms. Poolsawat stated that if the
nurse had written "no reddened area on coccyx," she would not have found
a documentation problem. Tr. 790. Despite my conclusion that there is a lack of specificity
in the documentation concerning the monitoring of Patient 9's skin, I
find that the hospice's omission in documentation is insignificant when
viewed in the context of the care provided to Patient 9. It is not disputed
that Patient 9 had a care plan for the skin and mucous membrane. Tr. 756;
HCFA Ex. 13 at 33. The fact that the hospice nurse failed to state explicitly
that she had examined the patient's coccyx area is not evidence that the
patient's skin care plan was not being maintained. The hospice's alleged noncompliance with the standard found at 42 C.F.R. � 418.58(b) (Tag L135) At the hearing, the hospice objected to any discussion
of Tag L135. Tr. 1296. The citation at Tag L135 references 42 C.F.R. �
418.58(b), which provides that, "The plan of care must be reviewed and
updated, at intervals specified in the plan, by the attending physician,
the medical director or physician designee and interdisciplinary group.
These reviews must be documented." HCFA Ex. 1 at 13. HCFA alleged in the
SOD that based on clinical record review and staff interview, the hospice
failed to ensure that this was done for one of five skilled nursing residents.
Id. at 13 - 14. According to the SOD, the surveyors conducted an
interview with a hospice staff member who, when questioned by the surveyors,
stated that, "I write approved by IDG (interdisciplinary group) and then
each of the members [sic] names on the form, then the changes to the care
plan is discussed during the meeting." Id. at 14. In the SOD, under Tag L136, HCFA alleges the violation
of 42 C.F.R. � 418.58(c), which states, in pertinent part:
HCFA contends that there were deficiencies for eight of
nine patients, based on the allegation that "[t]here is no documented
evidence of assessments of patients [sic] needs. The identified assessment
only includes a list of symptoms or concerns." HCFA Ex. 1 at 14 - 15.
Following this allegation is a recitation of the situations concerning
four of the hospice's patients: Patients 1, 5, 4, and 9. HCFA Ex. 1 at
15 - 18. There is an additional preliminary issue regarding Patients 4 and 9, and that is whether the time period relating to these alleged deficiencies is within the time frame under consideration in this Decision. In determining whether the hospice had deficiencies at the time of the June 1999 survey, I do not consider deficiencies that occurred on or before the exit date of the prior revisit survey, which was March 4, 1999. Libbie, supra, at 5. Below, with respect to Patient 9, I refuse to consider the alleged food/fluid care plan deficiency, because it pre-dates March 4, 1999. With respect to Patient 4, the hospice asks me not to consider alleged deficiencies that occurred prior to May 15, 1999, the correction completion date from the March 1999 survey. [The March 1999 SOD, showing the May 15, 1999 correction completion date, is attached to HCFA's Brief, not as evidence, but as illustration. HCFA Br., Attachment A; see also P. Br. at 33 (one page of the March 1999 credible allegation was submitted for the limited purpose of substantiating the correction completion date)]. The hospice explains,
P. R. Br. at 28. In response to alleged deficiencies from the March 1999 survey, the hospice submitted a credible allegation to HCFA.
P. Br. at 33. With regard to alleged deficiencies occurring between the exit date of the prior revisit survey (March 4, 1999), and the correction completion date contained in the hospice's credible allegation (May 15, 1999), I must determine on a case-by-case basis whether to consider the allegations. Under some circumstances, deficiencies occurring during that time frame could be the basis for termination. [A hospice does not enjoy a carte blanche type of free zone for deficiencies during such period.] Whether acts or omissions during that time frame will be considered depends on the nature of the alleged deficiencies and the nature of the hospice's correction. Here, under Tag L136, I find that the alleged deficiencies were based on the hospice not documenting assessments and services to be provided in a way HCFA regarded as satisfactory. Thus, with respect to Patient 4, HCFA must allow the hospice until the correction completion date, May 15, 1999, to change its method of documenting assessments, before citing it again with the same criticism.
In the case of Patient 1, HCFA alleged in the SOD that
her care plan for safety/hygiene stated that the nursing home staff was
"to notify [the hospice] immediately if pt [patient] falls or injuries
occur." However, HCFA contends that "[t]here is no documented evidence
of an assessment of the patient's risk for falls." The SOD notes also
that the care plan stated "Pt (patient) to call for assist [sic] to get
OOB (out of bed)." HCFA then goes on to allege, "However, the patient
was assessed to be confused. The plan of care failed to identify services
based on the assessment." HCFA Ex. 1 at 15. Based on the evidence, I find that Patient 1's care plan
for safety/hygiene adequately assessed her needs, and thus, there is no
basis to support a finding that the hospice failed to comply with the
standard established by the regulation. Patient 1 lived in a skilled nursing facility. Tr. 1329.
According to the medical record, the primary caregiver was her son. P.
Ex. 1 at 1. Patient 1 was diagnosed with end stage dementia. Id.
at 17; see Id. at 9. In Patient 1's interdisciplinary care plan for safety/hygiene,
dated May 12, 1999, the interdisciplinary team has indicated at the top
that the plan is related to the areas of "decreased mobility, safety."
HCFA Ex. 4 at 25. With respect to "patient/family expectation," the team
wrote "pt. confused, no family members avail." The care plan states that
the team goal is that Patient 1 will not have any falls or injuries. The
hospice listed the following interventions: "Pt. [patient] to call for
assist [sic] to get OOB [out of bed]; "BSR's [bed side rails] up at all
times when pt. in bed [sic] to be checked by all staff;" and "Nsg [nursing]
home staff to notify [the hospice] immediately if pt falls or injuries
occur." Id. The latter intervention is noted as being related to
the area of "safety/weakness." Id. HCFA argues in its brief that the care plan states only
that the patient should not have any falls or injuries, "without further
evaluating how much risk there was for such events to occur, and under
what circumstances the patient might fall." HCFA Br. at 87. According
to HCFA's surveyor, Cdr. Sadovich, "[t]here just wasn't any assessment
of the patient's risk for falls, or how their status would necessarily
lend itself to falls, or how that is necessarily an issue, or what the
surrounding issues are in terms of relationships to their falls." Tr.
1304. Cdr. Sadovich testified that the fact that the care plan indicates
that the patient has decreased mobility and is confused and weak, is not
an assessment of her risk for falls. Tr. 1328. Moreover, the surveyor
stated that the statement that the skilled nursing facility should notify
the hospice if the patient falls does not constitute an assessment. Tr.
1343. With respect to the patient's confusion, HCFA argues that the care
plan does not evaluate the degree of her confusion or "how her apparent
confusion might affect either her risk for falls or her ability to call
for assistance in getting out of bed." HCFA Br. at 87 - 88. The surveyor
testified that the notation that the patient was confused does not constitute
an assessment. Tr. 1346. HCFA contends also that the care plan fails to
identify what services the hospice would provide to manage the patient's
falls/injuries and her confusion. HCFA Br. at 88 - 89. I am not persuaded by HCFA's contentions. I find that
the care plan for safety/hygiene contains statements that indicate that
the hospice did assess Patient 1's risk for falls, and the assessment
was ongoing. On June 11, 1999, Patient 1 was assessed in her Plan of Care
file, via the nursing notes, as having poor balance, poor coordination,
and stiffness. HCFA Ex. 5 at 62. Moreover, the ongoing assessment under
Patient 1's Plan of Care #9 for Safety, as contained in the June 11, 1999
nursing notes, indicated that Patient 1 had poor coordination, poor balance,
and weakness. Id. at 63. These notations in the care plan provide
sufficient information such that they can be considered an assessment
of Patient 1's condition. The interdisciplinary team thus recognized that Patient
1 had decreased mobility, safety, and weakness concerns. The care plan
notations, taken together with the interdisciplinary team goal of "No
falls or injuries," strongly suggest that Patient 1 has been assessed
by the hospice and found to be at risk for falls. The interdisciplinary team indicated that Patient 1 was
confused and that she was to call for assistance to get out of bed. Contrary
to HCFA's arguments, these two items are not necessarily in conflict.
A patient who is confused may also be capable of calling for assistance.
The surveyor admitted that Patient 1 was described as "alert with periods
of confusion." Tr. 1337; P Ex. 1 at 18. With this intervention, the hospice
further recognizes Patient 1's functional limitations and addresses her
safety concerns. Had the hospice not included this intervention on the
care plan, Patient 1's safety could have been compromised, placing her
at higher risk for falls and injuries. Moreover, as pointed out by the hospice, in Patient 1's
initial plan of care, dated November 26, 1998, the hospice staff documented,
among other things, that she was unable to ambulate and required assistance
with transfers. P. Ex. 1 at 17. This information is further evidence to
support a finding that there was an assessment of Patient 1's condition.
One can reasonably conclude from the initial plan of care that the hospice
assessed that Patient 1 was at risk for falls. The documentation shows that the hospice coordinated with
the skilled nursing facility to prevent Patient 1 from falling or being
injured. P. Ex. 1 at 35; HCFA Ex. 4 at 25. The hospice was aware of the
nursing home care plan, which noted that Patient 1 was "[a]t risk of fall/injury
related to general weakness secondary to medical condition and taking
psychotropic medication." P. Ex. 1 at 35; see Tr. 1331. The hospice
directed the nursing home staff to notify it immediately if Patient 1
fell or injuries occurred, and the services that the hospice undertook
were to ensure that Patient 1 would call for assistance to get out of
bed, and to ensure that Patient 1's bed side rails were up at all times
when she was in bed, to be checked by all staff. HCFA Ex. 4 at 25. At
the hearing, Cdr. Sadovich admitted that she didn't see any evidence of
falls or injuries on the part of Patient 1. Tr. 1341. Finally, I find that Patient 1's care plan for safety
did identify services based on the assessment that she was confused. The
services that the hospice undertook, with respect to the patient's confusion,
were to ensure that the patient would call for assistance to get out of
bed, and to ensure that the patient's bed side rails were up at all times
when she was in bed, to be checked by all staff. HCFA Ex. 4 at 25. I find that HCFA has not established a prima facie basis that the hospice failed to satisfy the standard under Tag L136 by failing to assess Patient 1 or failing to identify services for Patient 1. Based on the evidence regarding Patient 1, there is no standard-level deficiency under Tag L136.
I conclude to the contrary; the evidence supports a finding
that the hospice satisfied the standard under Tag L136 and met Patient
5's needs in accordance with 42 C.F.R. � 488.26.
Patient 5 had a diagnosis of colon cancer. P. Ex.
5 at 1. The records contain a physician's order dated April 21, 1999,
approving the transfer of Patient 5 to a nursing home for a 5-day respite.
HCFA Ex. 9 at 3; P. Ex. 5 at 9.(12) Patient
5 continued to reside in the nursing home after that respite period was
over, and at the time of the June 1999 survey, was still there. Tr. 1351
- 1354; see HCFA Ex. 1 at 15. I find that the evidence does document why Patient 5 could not return home. In fact, the surveyor who testified concerning this patient admitted that the statement that the clinical record contained no documented evidence as to why Patient 5 could not return home, was incorrect. Tr. 1380. Specifically, on April 26, 1999, which is immediately after the respite period (Tr. 1360), the hospice physician documented on a Supplemental Interdisciplinary Note that ". . . Since adm. to service, pt. has had progressive weakness & inability for the caregiver to provide appropriate care. Therefore, he was transferred to Royalwood Care Center on 4/21/99. He has developed urinary retention & now has Stage I pressure lesions." HCFA Ex. 9 at 28. This note is considered to be part of Patient 5's plan of care. Tr. 1361. As such, it constitutes an assessment of the reason Patient 5 continued to reside in the skilled nursing facility after the conclusion of the respite period, specifically, that Patient 5's caregiver could not provide appropriate care given his deteriorating condition. See also, P. Ex. 5 at 8, 10, 12, 15; Tr. at 1379 - 1380. Thus, Patient 5's assessment immediately following his five days of respite care is documented and shows why Patient 5 could not return home. With regard to HCFA's contention that the hospice was unable to provide documentation as to why Patient 5's goal of returning home had not been "documented/assessed," HCFA primarily points to one comment made by the patient, contained in a nursing note dated May 17, 1999, to substantiate its contention that he even wanted to go home. According to this nursing note, Patient 5 stated, "I just want to go back home." HCFA Ex. 9 at 134; Tr. 1394 - 1395. Also, included among the nurse's comments was the statement that "Pt adjusting to facility but his goal is to return to home when he is stronger." HCFA Ex. 9 at 134. HCFA's argument that the hospice did not assess how Patient 5's desire to go home could be accomplished appears to be based solely on the hospice's comment. Specifically, HCFA argues that the hospice never assessed how it might be feasible for Patient 5 to return home in view of his expressed desire to do so, and, in view of the fact that any individual should be allowed to die at home, if at all possible. HCFA Br. at 92.I am not persuaded by HCFA's contentions and find that, given Patient 5's condition, the hospice was adequately assessing and documenting the situation. It was the choice of Patient 5 and his family that Patient 5 reside in the skilled nursing facility (Tr. 1386 - 1387), and the record is replete with examples of Patient 5's or his wife's statements that he understood that his wife could not care for him at home and that he was content with the decision that he remain in the skilled nursing facility. P. Ex. 5 at 10, 12, 14, 15, 17; HCFA Ex. 9 at 125, 143, 146; Tr. at 1366 - 1372, 1391 - 1392. The hospice plan of care for Emotional Reaction for Patient 5 was designed to meet Patient 5's emotional needs, especially with regard to his adjustment to living in the skilled nursing facility. P. Ex. 5 at 6 - 7. While Patient 5 may have, understandably, made the comment that it was his goal to go home, the record reflects that this may not have been a realistic goal given his condition. See Tr. 1372 - 1373, 1377 - 1378. Rather, the evidence shows that the hospice assisted Patient 5 in adjusting to his new living situation. Tr. 1362 - 1363, 1365, 1378. The hospice asserts that "there was no evidence that there was any need to assess or establish a goal for the patient to go home," since it was Patient 5 and his family who decided that Patient 5 would reside in the skilled nursing facility. P. Br. at 127. Under these circumstances, with Patient 5 and his family having chosen a skilled nursing facility placement, I find that the hospice had no duty to assess or establish a goal for Patient 5 to go home, but that it had made an appropriate choice rather to help him adjust to his new living situation. See Tr. at 1359 - 1360, 1362 - 1363, 1365, 1372, 1376 - 1379, 1389. Still, HCFA asserts that its prima facie case that the hospice did not assess the situation is not undercut by the hospice's attempts, during cross-examination of HCFA's witness, to point to evidence in the record regarding Patient 5's weakened condition, and the apparent difficulties expressed by Patient 5's wife in caring for him. HCFA Br. at 92. Rather, HCFA stresses that there is no evidence that Patient 5 and his family were ever fully informed of their options. Id.; Tr. 1392 - 1394. HCFA's argument does not persuade me. To the contrary, the evidence demonstrates that the hospice realistically assessed Patient 5's circumstances, given his need for skilled nursing care. The evidence shows further that the hospice accommodated the option selected by Patient 5 and his family, that Patient 5 remain in the nursing home, and provided compassionate care regarding his adjustment. Based on the foregoing, I find that HCFA has not met its burden of proving a prima facie case that the hospice failed to satisfy the standard under Tag L136 by failing to assess Patient 5's needs or to identify services that met his needs.
HCFA alleges in the SOD, "There was no evidence of an assessment as to the need for a change in pain medications." HCFA Ex. 1 at 16. On February 9, 1999, Patient 4's pain medication was switched from Vicodin (tablet form) to Lortab elixir (liquid form), to be given every six hours and as needed every three hours. HCFA Ex. 8 at 5. HCFA could not find "an assessment as to the basis for changing the patient's pain medication," or documentation showing "why the prior interventions were deemed inadequate to address the patient's comfort level." HCFA Br. at 94; see HCFA Ex. 1 at 16. The lack of documentation regarding Patient 4's pain medication change on February 9, 1999, which predates the prior survey, will not be considered here. HCFA argues that I should evaluate this as a June 1999 survey deficiency, because the late entry into the record was dated April 20, 1999. HCFA Ex. 8 at 5. As stated above, however, I agree with the hospice that HCFA must allow the hospice until the completion date, May 15, 1999, to change its method of documenting assessments and services to be provided. Consequently, under Tag L136, I will not consider Patient 4's pain medication change in February 1999 with regard to alleged deficiencies during the June 1999 survey.The next aspect of Patient 4's pain management that concerned
HCFA occurred in June 1999, and I will consider it. HCFA expected the
hospice documentation to acknowledge and show a response to the nursing
home staff's observation of repeated instances of Patient
4's pain at level 4. HCFA Ex. 1 at 16 - 17; HCFA Br. at 94. According
to the SOD,
HCFA Ex. 1 at 16 - 17. The hospice used a non-verbal scale to evaluate pain,
which I would expect to be especially helpful for Patient 4, a 65 year-old
whose terminal diagnosis was "cerebral degeneration (dementia) except
Alzheimer's." HCFA Ex. 8 at 1. She was nonverbal. She also had dysphagia
(difficulty swallowing) and anorexia. The hospice scale was different
from the scale used by the nursing home, but both providers had documented
Patient 4's pain level as zero, at one or more times during the first
three weeks of June 1999. HCFA Ex. 8. Thus, the evidence shows that Patient
4's pain was, at times, zero, and, at times, as high as 4 on a scale of
0 - 10. The "as needed" availability of the Lortab elixir suggests that
we would not expect Patient 4's pain level to remain constant. HCFA did
not prove that the hospice was unaware of or unresponsive to Patient 4's
pain level. HCFA did not prove that Patient 4's pain management should
have been different. HCFA did not prove that the hospice's method of documenting
Patient 4's pain assessments and services to be provided was inadequate.
See discussion infra under Tag L124. I find that HCFA failed
to establish a prima facie case under Tag L136 that the hospice was deficient
regarding documenting Patient 4's pain assessments and services to be
provided. Patient 4's nutritional needs, given her anorexia and weight loss, were also found by HCFA to be inadequately addressed in documentation of assessments and services to be provided. HCFA Ex. 1 at 17 - 18. Patient 4's plan of care for food/fluid is found in HCFA Ex. 8 at 7 - 8, and P. Ex. 4 at 110 - 113. The plan of care noted that Patient 4's husband just wanted her to eat as long as she could. The team goal was that she would be provided nourishing meals and supplements as tolerated. The skilled nursing facility was feeding Patient 4 a pureed diet with no concentrated sweets; eight ounces of high protein nourishment, in-between-meals, three times a day; and a multi-vitamin, vitamin C, and zinc, in order to assist metabolism. The hospice nurse was to encourage her intake and to monitor the percent of her meals consumed every visit. Tr. 905 - 908; HCFA Ex. 8 at 7 - 8, 21, 104. HCFA stated suggestions in the SOD for additional nutritional effort, such as assessing Patient 4's food preferences, use of alternative food forms (i.e. finger foods), favorite meals, or length of time needed to eat. HCFA Ex. 1 at 17 - 18. These may be good ideas, though Patient 4's dysphagia would be expected to impose certain limits, but I find that a failure to have incorporated these ideas would not constitute, under the regulation, a failure to document Patient 4's nutritional assessments and services to be provided. The SOD also states, at 18, "Nor was there evidence of other factors which may impact appetite such as the effects of pain, constipation, blood glucose levels or use of antipsychotic medications and social isolation." What was meant in the SOD, I believe, was that the surveyors did not find evidence that such factors had been evaluated or assessed. The record contains evidence to the contrary, but again, a failure to document evaluation or assessment of such factors would not constitute, under the regulation, a failure to document Patient 4's nutritional assessments and services to be provided. I find that HCFA failed to establish a prima facie case under Tag L136 that the hospice was deficient regarding documenting Patient 4's nutritional asessments and services to be provided.
This situation, described on page 18 of the SOD (HCFA
Ex. 1 at 18), is detailed above under Tag L133. Here, under Tag L136,
I again find that the documentation is inadequate to inform me whether
the hospice nurse specifically observed Patient 9's coccyx area
on June 14, 1999. Nevertheless, there was no evidence that the care provided
to Patient 9 failed to meet her skin care needs. Accordingly, as under Tag L133, I conclude that the hospice's
documentation omission is insignificant and does not support a finding
of noncompliance with the standard under Tag L136. The evidence does not
show a failure by the hospice to provide Patient 9 with the skin and mucous
membrane assessments she needed or to provide her with the services that
met her skin care needs. Thus, based on the evidence regarding Patient
9, I find that HCFA failed to establish a prima facie basis that the hospice
failed to satisfy the standard under Tag L136. With regard to "[P]atient 9's care plan #5 which was written
for food/fluid on 1/25/99" (HCFA Ex. 1 at 18), the time of the alleged
deficiency is not under consideration here. In determining whether the
hospice had deficiencies at the time of the June 1999 survey, I will not
consider deficiencies that occurred on or before the exit date of the
prior revisit survey, on March 4, 1999. The hospice's alleged noncompliance with the standard found at 42 C.F.R. � 418.58(c) (Tag L137) In the SOD, under Tag L137, HCFA alleges the violation of 42 C.F.R. � 418.58(c), which states, in pertinent part:
HCFA alleges deficiencies for six patients: Patients 5,
7, 6, 4, 2, and 9. HCFA Ex. 1 at 18 - 24.
HCFA alleges that three care plan items for Patient 5
"failed to state in detail the scope and/or frequency of services." HCFA
Ex. 1 at 19 - 20. The three items concern "Elimination," "Emotional Reaction,"
and "Safety/Hygiene." With regard to this alleged deficiency regarding
Patient 5 under Tag L137, I adopt and incorporate the hospice's reasoning,
which I summarize here. P. Br. at 139 - 150. Cdr. Sadovich testified that hospices must state in the
plan of care what they are doing for the patient, when or how frequently
they want it done, and who is supposed to perform the intervention.
See, e.g., Tr. at 1397 - 1398; 1402 ("Who, how, and when,
exactly, are they going to do that?"). In order to determine compliance,
Cdr. Sadovich examined the list of interventions or actions ordered
by the IDG in order to determine if the scope and frequency, as she defines
it, are listed in the interventions. For example, Cdr. Sadovich criticized the intervention
listed for Patient 5 on the plan of care for Elimination that instructed
the nurse to "[m]onitor skin for signs of redness, breakdown," alleging
that this intervention failed to state how frequently the staff was performing
the assessment, who is doing the assessment, and what part of the body
was to be assessed. HCFA Ex. 1 at 19; Tr. 1397 - 1398. The regulation at L137 requires that the "scope" and "frequency"
of the services must be listed in the plan of care. The regulation does
not define these terms and HCFA has not issued any official interpretations
that specifically define these terms. Tr. 1615, 1617. Therefore, the common
usage of these terms would apply to assist hospices in complying with
this regulation. The meaning of the word "frequency" in this regulation
does not appear to be in controversy as much as the meaning of the word
"scope." According to its common meaning, the term "scope" means "the
extent of treatment." Webster's Collegiate Dictionary, 10th
Ed. (1996) at 1047. In the SOD, HCFA alleges that the care plan for Patient
5 fails to state in detail the scope and/or frequency for the following
services:
HCFA Ex. 1 at 19. Cdr. Sadovich testified that the hospice failed to state
either the scope or frequency for the listed interventions. Tr. 1397 -
1398. She then clarified that the primary problem with these interventions
was the lack of a statement of the frequency of the intervention. Tr.
1398 (" . . . predominantly it's the frequency in this case"). However,
contrary to HCFA's allegations, the hospice did comply with this regulation
by ensuring that the scope and frequency for the cited interventions are
documented on the plan of care. As Cdr. Sadovich conceded, the Plan of Care Case Conference
Summaries are considered to be part of the hospice plan of care. Tr. 1408
- 1409. In addition, as Cdr. Sadovich conceded and as the hospice informed
HCFA in the Credible Allegation submitted to HCFA following the March
survey, the frequency of the visits by all hospice disciplines
is reviewed by the hospice IDG and then listed on the Interdisciplinary
Case Conference Summaries. Tr. 1409. See HCFA Br., Attachment A
at 61; see, e.g., P. Ex. 5 at 2, 3, 6, 7, 18, 27 for Case
Conference Summaries for Patient 5. For example, on the Case Conference Summary covering the period from May 26, 1999 to June 9, 1999, the nurse was assigned to visit Patient 5 one to two times a week and the home health aide was assigned to visit two to three times a week. P. Ex. 5 at 54. The services provided by each of the hospice professionals were listed on the numbered Plan of Care forms. Tr. 1405 - 1408, 1415. For example, for Patient 5, the nurse was assigned to monitor the patient's skin condition. See P. Ex. 5 at 18 (The "Disc." [discipline] box states that the RN was assigned to monitor the skin for redness and breakdown). As Cdr. Sadovich conceded, since the tasks on the hospice plan of care are assigned to individual hospice professionals, i.e., RN, social worker, chaplain, etc., and these personnel are assigned to visit the patient at certain intervals, it is logical to assume that these staff members will perform all of the assigned tasks during each visit, unless otherwise stated in the plan of care. Tr. 1410, 1413, 1428 - 1429. For example, the nurse assigned to Patient 5 would monitor the patient's skin for breakdown and redness during each of her visits. Therefore, the frequency of the services provided to the patients would be found in the hospice plan of care system by examining the Plan of Care forms and the Case Conference Summaries. The hospice contends there should have been no difficulty understanding that the frequency of the services are listed on the hospice Case Conference Summaries, since this system was specifically discussed in the credible allegation submitted after the March survey.HCFA failed to establish a basis for its allegations that the scope of these services was not listed in the plan of care. Each of the interventions listed for Patient 5 under Tag L137 as an area of deficiency describes activities that professionals in the field would readily understand and carry out due to that professional's training, education, and understanding of the professional standard of practice in that discipline. For example, the registered nurse assigned to "monitor skin for redness and breakdown" would be able to carry out these instructions based on her training and the professional standards of nursing practice. Cdr. Sadovich, despite her reluctance to admit this, understood perfectly, due to her training in the professional standards of nursing practice, that this order meant to observe, monitor or look out for redness or skin breakdown on all parts of the patient's body skin area. Tr. 1416 - 1423. Therefore, the scope of the nurse's skin monitoring is clearly stated in this intervention, contrary to HCFA's assertions under Tag L137. The chaplain and social worker were instructed on the plan of care to perform several tasks, including provide active listening and companionship, help the patient find spiritual issues, facilitate adjustment to the care center place, etc. The chaplain and social worker are trained to perform these interventions and would not need any more description of these interventions to be able to carry out these assignments. For example, the social worker learns how to conduct "active listening" as a part of his/her training. It is sufficient to identify the scope of such services by directing the chaplain or social worker to perform this intervention. Tr. 1425. This is also true of an order for the chaplain or social worker to provide companionship, assist the patient in coping with the terminal diagnosis and anticipated grief, help the patient find spiritual strength through prayer, and adjust to the care center. Tr. 1425 - 1426. Therefore, the scope of the services that were being provided by the chaplain and social worker were adequately delineated in the plan of care. HCFA Ex. 9 at 74 - 75, 124 - 128, and 145 - 146.This line of reasoning applies also to the final area listed as an alleged violation of the regulation at Tag L137 under the care plan for Safety/Hygiene. The interventions listed, to monitor the patient's ability to transfer and ambulate, and to reinforce safety and fall precautions, were assigned to the registered nurse to perform. P. Ex. 5 at 27 - 28. The scope is inherent in the instruction. I find that, without any further explanation of the tasks in the plan of care, the registered nurse would be able to perform these tasks, based on her expertise and professional training. There was no evidence to the contrary. Therefore, the statement of the services listed on the Safety care plan also contained a statement of the scope of the services. The evidence does not persuade me that the hospice failed to state the scope and frequency of the services for Patient 5 under Tag L137. I find that HCFA has failed to establish a prima facie basis for this alleged deficiency.
With regard to this alleged deficiency regarding Patient 7 under Tag L137, I again adopt and incorporate the hospice's reasoning, which I summarize here. P. Br. at 139 - 156. The alleged deficiencies under Finding 2 appear to be based on the fact that the hospice does not complete the section entitled "Team goal, if changed" on the "shingles" which are used to update the patients' plans of care, unless the team goal actually changes on that date. HCFA Ex. 1 at 20 - 22. When that section of the form is left blank, the previously established team goal remains in effect. Perhaps the alleged deficiencies that were based on the goal having been left blank, would not have been cited, if the surveyors had understand the hospice's procedure. Ms. Garces testified regarding Findings 2(a), 2(b), 2(b) [sic], and 2(c) [sic] (Patient 7). The hospice asserts that HCFA has failed to establish any basis for these allegations.The meaning of the word "scope" is dramatically different
from the meaning of the word "goal," which means the "end toward which
effort is directed." Webster's Collegiate Dictionary at 499. Notably,
the definition for "scope" does not include "goal," nor are any of the
definitions for the term "scope" synonymous with the term "goal," as Ms.
Garces claims. Based on the common meaning of the words, therefore, there
is no basis for Ms. Garces' contention that the "scope" of services in
the plan of care is defined solely by a statement of the goals for that
plan of care. Tr. 1579 - 1617. The hospice indicates that there is also no definition
of the word "scope" in the Interpretive Guidelines (IG) for the regulation
at Tag L137. The IG list some "probes" that the surveyors are required
to ask in a hospice survey to determine compliance with Tag L137. See
P. Br., Attachment C. These probes all pertain to ensuring that the patient
is receiving the hospice services he/she requires. Id. The hospice
asserts that nothing in the language of the IG even suggests that "scope"
is defined as goal. Rather, the hospice maintains, it appears that the
IG intend that the surveyor review the entire plan of care in order to
determine if the scope and frequency of the services is stated and to
determine if the patient's needs are being met. Based on the foregoing, the hospice contends that the surveyors' interpretation of this regulation, particularly Ms. Garces' interpretation of this regulation that "scope" is defined as "goal," is not reasonable and therefore, may not be used as a legitimate basis for this allegation. The hospice states that it is also unreasonable for HCFA to interpret this regulation to mean that the plan of care must state exactly which discipline is providing the services, as Ms. Sadovich expressed in her testimony. Tr. 1398, 1402. At least one of the surveyors admitted that the citations to deficiencies under this regulation are not based on a failure to state which discipline will be performing the service. Tr. 1413. This alleged requirement is not expressly stated in the regulation at L137 or in the IG for this regulation and is unreasonable, argues the hospice. Nevertheless, one of the surveyors conceded that there is documentation on the plan of care that indicates who will be providing service to hospice patients. See, e.g., Tr. 1407 - 1408, 1415. Even if it were determined that HCFA's interpretation(s) of this regulation are reasonable, there is no evidence that hospices were provided notice of this interpretation. For example, HCFA has failed to demonstrate that the hospice here, and the hospice industry, were provided notice of HCFA's interpretations of this regulation that the hospice must list a "goal" in order to fulfill the requirement for having the scope of the intervention in the plan of care, as Ms. Garces stated, or that the "reason" for the intervention must be listed where the goals state the reason for the intervention.For Patient 7, I find that the scope of each of the interventions identified as deficient under Tag L137 is contained within the plan of care. I find that HCFA failed to establish a deficiency under Tag L137 for any of the cited findings for Patient 7. I find further that these allegations fail to establish a prima facie basis for a deficiency.
In its opening brief, at footnote 33, the hospice contends
that "[t]here was absolutely no testimony or evidence presented at the
hearing regarding Finding #3 (Patient #6) under L137. Therefore, this
allegation must be disregarded for purposes of this termination action."
P. Br. at 141 n.33; see P. Br. at 151. Nevertheless, I will address the alleged deficiency in the SOD. HCFA does not dispute the hospice's claim that it did not present any evidence at the hearing concerning the allegations under Finding 3. In its response brief, HCFA alleges that the hospice plan of care for Patient 6 failed "to specify any scope of the plan for food/fluid as related to the patient's anorexia/weight loss." HCFA Br. at 142. HCFA did not discuss this allegation further. HCFA did not discuss Finding 3 at all other than to mention
it (i.e., Patient 6) in a cursory fashion when summarizing the
deficiencies listed under Tag 137. The alleged deficiency regarding Patient
6 appears to be based on the fact that, on a June 25, 1998 care plan update
("shingle") related to the patient's anorexia/weight loss, the hospice
did not complete the sections entitled "Patient/Family Expectation, if
changed" and "Team Goal, if changed." These sections have been left blank.
See HCFA Ex. 1 at 22; HCFA Ex. 10 at 14. As I stated above in my discussion concerning Patient
7 under this tag, the hospice would not complete the section "Team Goal,
if changed," on the care plan update ("shingle") unless the team goal
actually changed. This would also hold true for the section, "Patient/Family
Expectation, if changed." When these sections of the care plan update
("shingle") are left blank, the previously established patient/family
expectation and team goal remain in effect. The intervention on the June 25, 1998 care plan update
("shingle"), which was approved by the interdisciplinary group, states
that the hospice nurse "will assess dietary intake and offer suggestions
as appropriate for pt. condition/disease progression q visit." HCFA Ex.
10 at 14. I find that the scope and frequency of this intervention is
evident. I find that HCFA has failed to establish a deficiency under Tag
L137 for Patient 6.
With respect to Patient 4, who was discussed previously,
the SOD alleges that the care plan for pain management contains an on-going
intervention, updated May 21, 1999, which states that the nursing home
would assess the patient for signs and symptoms of pain and was to notify
the hospice of increased pain or pain unrelieved by medication. HCFA Ex.
1 at 22. Additionally, the SOD states that the hospice had added an entry
to Patient 4's nursing home care plan that the nursing home was to call
the hospice if the patient had pain at a level of 2 or above on the non-verbal
scale of 0 - 10. However, contends the SOD, "[t]here was no indication
as to when or how often the pain scale assessment should occur." HCFA
Ex. 1 at 22; see HCFA Ex. 8 at 85. I do not agree with HCFA's allegations that the above-mentioned
interventions relating to Patient 4's pain management and pain scale assessment
do not state in detail the scope and frequency as required under the regulation.
Thus, there is no basis to support a finding that the hospice failed to
comply with the standard established by the regulation. At the hearing, Cdr. Liebmann testified concerning this
alleged deficiency. With respect to the intervention in Patient 4's pain
management care plan, Cdr. Liebmann testified that it does not state "what
days of the week they will assess the pain, what shifts they will assess
the pain, or how often during each shift . . . There is no indication
which long term care staff is responsible for assessing the pain." Tr.
1084; see Tr. 1098. Cdr. Liebmann stated that the intervention
"doesn't state the scope and frequency." Tr. 1098. As to the latter part
of the deficiency citation relating to the pain scale assessment, Cdr.
Liebmann asserted that the basis for this finding was that "there's no
indication who would do that assessment . . . no indication as to how
often it should be done, what time of day the pain assessment should be
done." Tr. 1083; see Tr. 1085, 1091. Cdr. Liebmann stated that
the care plan entry "did not identify the scope and frequency of when
the pain should be assessed and when to give the appropriate pain medication
as needed." Tr. 1087. In examining the two care plan interventions in question,
I find that the scope of services is adequately stated. As written, the
care plan interventions contain sufficient information describing what
type of care the nursing home staff was to be rendering to Patient 4.
The interventions address the management of Patient 4's pain and the assessing
of her pain by the nursing home staff. Although the care plan interventions do not specify when
or how often the pain assessments should occur, I find also that the interventions
satisfy the frequency requirement under the regulation. The hospice contends
that there was no need to explicitly state how often these interventions
should be carried out, because professional standards of nursing practice
dictate that certain types of assessments, such as skin and pain assessments,
are to be performed by a nurse automatically each time the nurse observes
a patient. This argument was not contradicted by Cdr. Liebmann. On cross-examination,
Cdr. Liebmann agreed that the intervention, "Long-term care facility to
assess patient for signs and symptoms of pain," carries an implicit expectation
that as "good nursing practice," the staff should assess Patient 4 for
pain upon each professional contact with the patient. Tr. 1090. Cdr. Liebmann
testified that "[i]ndirectly you could say [frequency] was there." Tr.
1092. Although she qualified her response by stating further that doing
a pain scale assessment would involve more methodology than mere observation
of the patient, Cdr. Liebmann admitted that the signs and symptoms of
pain are ascertainable by observing the patient. Tr. 1092 - 1093; see
Tr. 1091. Thus, although the frequency for carrying out the interventions
was not explicitly spelled out, I am persuaded that the nursing home staff
members would know that they were to perform a pain assessment each time
one of them saw Patient 4. Cdr. Liebmann conceded that if nursing home staff had memorized the non-verbal pain scale, it would be possible for them to determine how much pain the patient was experiencing by observing her. Tr. 1093. She acknowledged that the nursing home staff had received training on the non-verbal pain scale. Tr. 1093 - 1094. I note also that Cdr. Liebmann modified her testimony
as to what the regulation requires. Cdr. Liebmann conceded on cross-examination
that the deficiency was not based on a failure to indicate how frequently
the pain medication would be given. Tr. 1087 - 1088. She admitted also
that the deficiency was not based on a failure to designate which nursing
home staff member would be doing the pain assessment. Tr. 1102. The evidence is insufficient for me to find that the hospice
failed to state the scope and frequency of services, as required under
42 C.F.R. � 418.58(c), for Patient 4 under SOD Finding 4 under Tag L137.
I find that HCFA has failed to establish a prima facie basis for this
alleged deficiency.
Patient 4, who was discussed under the previous finding,
is also the subject patient of this finding. Under this finding, HCFA
contends in the SOD that while Home Health Aide/Homemaker notes indicated
that both passive and active range of motion (ROM)(14)
had been provided, there was no evidence of an order for ROM on the Interdisciplinary
Care Plan, nor was there "any reference to the duration, scope and frequency"
of the intervention. HCFA Ex. 1 at 22 - 23. Moreover, HCFA alleges that
the "hospice addendum to the nursing home care plan . . . did not include
any interventions for the hospice [home health aide] to provide [ROM]."
Finally, HCFA contends that the nursing home care plan for [ROM] stated
that the nursing home restorative aide would provide passive ROM, with
no mention that the hospice staff was also providing this care. Id.
at 23. I conclude that HCFA's allegations concerning the ROM
interventions for Patient 4 are without basis. With respect to the Home Health Aide/Homemaker Request
form dated May 24, 1999, Cdr. Liebmann testified that it indicates that
the home health aide will visit two to three times a week. Tr. 1122, 1133;
see HCFA Ex. 8 at 14; P. Ex. 4 at 185.(15)
Cdr. Liebmann stated further that, while the request form indicates that
active and passive ROM are the activities to be performed by the home
health aide, it does not specify whether ROM exercises are to be done
on each visit or the duration of the ROM activity. Tr. 1122. Moreover,
Cdr. Liebmann testified that the request form did not indicate the scope
of the ROM activity, i.e., which body part or which extremities
were to receive ROM exercises. Tr. 1122 - 1123.(16) With respect to the Home Health Aide/Homemaker Notes (see
HCFA Ex. 8 at 44 - 50), Cdr. Liebmann testified that the notes show only
that passive and active ROM were performed by the home health aide. See
Tr. 1123 - 1126. Cdr. Liebmann stated that nowhere in the notes did the
home health aide specify the scope and frequency of the ROM activity.
Tr. 1124, 1126. Cdr. Liebmann explained that frequency is "measured by
the number of repetitions done in exercising a particular body part."
Tr. 1124. That may be one interpretation of frequency, but other interpretations
could also be valid. For example, the number of times during a day or
during a week or during a month might also indicate frequency. On cross-examination, however, Cdr. Liebmann conceded
that the frequency of the ROM activity is documented on the Home
Health Aide/Homemaker Request form dated May 24, 1999. Cdr. Liebmann admitted
that, since the home health aide visits would be occurring two to three
times a week and the home health aide would presumably be performing active
and passive ROM exercises at each visit, the request form does
indicate the frequency of the active and passive ROM exercises. Tr. 1134;
see Tr. 1135. With respect to the "scope" requirement, the hospice asserts
that the reference to active and passive ROM sufficiently
conveys the scope of the ROM activity. P. Br. at 160 - 161. Moreover,
the hospice asserts that Cdr. Liebmann's opinions regarding ROM orders
should not be given any weight since she admitted she has not received
any formal training on ROM and is not qualified to perform ROM under her
license. P. Br. at 161; See Tr. 1137. The hospice contends that
Cdr. Liebmann's testimony was unsupported by any authoritative source
concerning the appropriate manner in which ROM orders are to be written. I do not read the plain meaning of the regulation as requiring
the level of detail which Cdr. Liebmann interpreted it to require. There
is nothing in the regulation that specifically requires ROM orders to
identify specific body parts or state the number of repetitions. Moreover,
I agree with the hospice that Cdr. Liebmann does not possess the necessary
qualifications or expertise to opine whether a ROM order was adequately
written. Cdr. Liebmann testified that she has not performed ROM activities.
Tr. 1138. I do not find that her experience as a registered dietician
and dietary consultant qualifies her to attest to what should be contained
in a ROM order. Moreover, HCFA did not offer any expert testimony or other
evidence, other than Cdr. Liebmann's testimony, to support its interpretation. Accordingly, I conclude that the ROM interventions contained in the Home Health Aide/Homemaker Request, as well as the Home Health Aide/Homemaker Notes, adequately comport with the scope and frequency requirements of 42 C.F.R. � 418.58(c). I find that the fact that the Request form and Notes state that Patient 4 would be receiving active and passive ROM sufficiently addresses the scope of the ROM activities. Also, as Cdr. Liebmann admitted, the request form does indicate the frequency of the ROM intervention in that the frequency can be inferred from the number of home health aide visits. I also note that the regulation does not contain any requirement
that the duration of an intervention be specified. Indeed, Cdr. Liebmann
conceded that no such requirement existed. Tr. 1136. Furthermore, I note that Cdr. Liebmann apparently was under the misimpression that the Home Health Aide/Homemaker Request form was not part of the plan of care, and this formed the basis for her statement in the SOD that there was no documentation of ROM activity on the interdisciplinary care plan. See Tr. 1132. However, Cdr. Liebmann testified that she became aware prior to the hearing that the request form is considered by the hospice to be part of the plan of care, and acknowledged this fact at the hearing. Tr. 1121, 1153 - 1154; see Tr. 1131 - 1132. Moreover, the hospice directed Cdr. Liebmann's attention to the fact that, under the hospice's written care plan policy, the Home Health Aide/Homemaker Request form is considered by the hospice to be part of the "working care plan file." Tr. 1155 - 1156; see P. Ex. 30 at 3. Thus, contrary to what was alleged in the SOD, it is clear from the record that Patient 4's care plan did contain documentation that ROM activity was to be performed since this intervention was contained on one of the documents designated by the hospice as being part of a patient's care plan file. Finally, I am not persuaded that HCFA has established a prima facie case with respect to the allegations contained in the SOD concerning the "hospice addendum to the nursing home care plan" and the "nursing home care plan" itself. See HCFA Ex. 1 at 23. In her testimony, Cdr. Liebmann referred to page 80 of HCFA Ex. 8 as "[the hospice's] addendum to the nursing home plan of care." Tr. 1126. This document is the nursing home care plan for Patient 4, with an order by one of the hospice staff nurses added to it in the right-hand column entitled "Approach or Plan." HCFA Ex. 8 at 80; P. Ex. 4 at 18. See Tr. 1127, 1144 - 1145. Cdr. Liebmann stated that the hospice nurse's order indicates that the nursing home restorative nursing aide would be providing passive ROM to the upper and lower extremities daily. Tr. 1126, 1127. According to the allegation in the SOD and Cdr. Liebmann's testimony, this additional order by the hospice nurse failed to make any reference to the fact that the hospice home health aide would also be providing ROM activities in accordance with the hospice's own care plan (as discussed above). HCFA Ex. 1 at 23; Tr. 1127. Cdr. Liebmann stated further that the hospice care plan did not mention the ROM interventions stated on the nursing home care plan. Tr. 1129. Cdr. Liebmann asserted that although both the hospice and the nursing home were providing ROM exercises to Patient 4, she found no evidence of any coordination between the two care plans. Tr. 1127 - 1130.The regulation itself, 42 C.F.R. � 418.58(c), does not contain any requirement for "coordination" of care plans. Assuming for the sake of argument, that a requirement exists elsewhere(17) that the hospice care plan and the nursing home care plan be "coordinated," I do not find that a lack of coordination exists based on the fact that Patient 4 had two different ROM orders in two different care plans. There is no requirement that the two care plans be the same with regard to the ROM therapy, or that they reference one another. The hospice, to satisfy the standard under Tag L137, has to ensure that the scope and frequency of Patient 4's ROM exercises is adequately identified. At the hearing, hospice counsel suggested through her cross-examination of Cdr. Liebmann that hospice staff would have been aware of the nursing home ROM order for Patient 4, since that ROM order was added to the nursing home care plan by a nurse on the hospice staff. Tr. 1144 - 1145. Cdr. Liebmann acknowledged during cross-examination that it appeared that the hospice registered nurse [S. Gray] was "quite clearly aware that the [nursing home] restorative nurse aide was performing range of motion to this patient daily . . ." Tr. 1145. I first conclude that the ROM order contained in the nursing home care plan, in and of itself, satisfies the scope and frequency requirements of the regulation. I further conclude that it is more probable than not that the hospice nurse was aware that a nursing home restorative nurse aide would be providing ROM exercises to Patient 4, and also careplanned for a hospice home health aide to provide additional ROM exercises. As indicated above, the ROM interventions contained in the Home Health Aide/Homemaker Request, as well as the Home Health Aide/Homemaker Notes, adequately comport with the scope and frequency requirements of 42 C.F.R. � 418.58(c). Moreover, there was no showing by HCFA that the ROM activity provided to Patient 4 was either inadequate or in excess of what she needed, or that the hospice failed to meet the ROM needs of Patient 4 in accordance with 42 C.F.R. � 418.58(c). There is insufficient evidence to show that the hospice
failed to state the scope and frequency of the ROM interventions for Patient
4 under Tag L137. I find that HCFA has failed to establish a prima facie
basis for this alleged deficiency.
With respect to Patient 2, HCFA alleges in the SOD that
"[t]here was no documented evidence of the duration, scope and frequency
of when [Patient 2's] splint should be applied" and "[t]here was no indication
on either the hospice or nursing home plan of care that ROM would be provided
by the hospice HHA [home health aide], nor was there documentation indication
[sic] duration, scope and frequency of the range of motion." HCFA Ex.
1 at 23 - 24. I conclude that HCFA's allegations are without support
in the record. I shall first discuss HCFA's contention regarding Patient
2's splint. Patient 2's hospice care plan for safety/hygiene stated the
following intervention relating to range of motion/weakness: "Splint per
MD order; to be paid by hospice." This intervention is dated March 18,
1999. HCFA Ex. 6 at 10; P. Ex. 2 at 96. The surveyor, Cdr. Liebmann, testified that this intervention,
as written in the (hospice) care plan, did not indicate the scope and
frequency regarding the use of the splint. Tr. 1159, 1168, 1169. She stated
that the intervention does not provide any information as to the location
of the splint or how long the patient was to wear the splint. Tr. 1162
- 1164. The hospice responded to Cdr. Liebmann's testimony by
asserting that the physician's order ("MD order") which is referenced
in the March 18, 1999 care plan intervention contains a complete description
of the use of the splint. P. Br. at 163. This physician's order is listed
on a separate document and is dated March 18, 1999, which is also the
date of the care plan intervention. The order states as follows: "Apply
(R) ue [upper extremity] hand splint to prevent loss of rom to wrist and
finger extension. Max 6 hrs release Q 2 hrs x 15 mins check for redness
& circulation." P. Ex. 33 at 2. On cross-examination, Cdr. Liebmann
did not dispute that this physician's order was the "MD order" referenced
in the care plan intervention. Tr. 1172 - 1173. In fact, Cdr. Liebmann
essentially conceded that she had not seen this order during the survey
or made any inquiries of the hospice staff as to what particular "MD order"
was being referenced in the intervention. Tr. 1174 - 1175. It is thus clear from the record that the care plan intervention
incorporated the March 18, 1999 physician's order concerning the use of
the splint. Moreover, I agree with the hospice that the March 18, 1999
physician's order, which was incorporated into the care plan intervention,
satisfies the scope and frequency requirements of 42 C.F.R. �
418.58(c). The physician's order, as written, states detailed instructions
and addresses scope and frequency regarding application of the splint.
Furthermore, Cdr. Liebmann did not dispute on cross-examination that this
order does indicate the duration, scope and frequency of when the splint
should be applied. Tr. 1175. Consequently, I find that Cdr. Liebmann's
testimony on direct examination that the care plan intervention lacked
any information regarding the splint is not supported by the record. I
conclude that HCFA has failed to establish that the care plan intervention
does not state the scope and frequency for use of the splint. HCFA makes other allegations in the SOD concerning Patient
2's documentation. HCFA states that a hospice Home Health Aide/Homemaker
Note indicated that the patient was receiving active and passive ROM.
HCFA asserts further that the nursing home care plan stated that ROM would
be conducted by the nursing home restorative aide. See HCFA Ex.
1 at 23. HCFA points also to a May 21, 1999 hospice entry to the nursing
home care plan, which indicated agreement with the nursing home's approach
regarding ROM. See Id.; HCFA Ex. 6 at 22. Based on the foregoing,
HCFA contends in the SOD that neither the hospice nor nursing home care
plans indicated that "ROM would be provided by the hospice HHA." HCFA
Ex. 1 at 23 - 24. Morever, HCFA alleges that there was no "documentation"
indicating the "duration, scope and frequency of the range of motion."
Id. at 24. First, in reviewing the hospice care plan, I find HCFA's
contention that the care plan did not indicate that a home health aide
would be providing ROM to have no basis in the record. The "Home Health
Aide/Homemaker Note" form used by the hospice states at the top "Plan
of Care File." Thus, one cannot dispute that the Home Health Aide/Homemaker
Note, which indicated that the patient was receiving active and passive
ROM, is part of Patient 2's care plan. Moreover, this form was
completed and signed by a home health aide. HCFA Ex. 6 at 18. The fact
that the Note was signed by a home health aide presumably indicates that
a home health aide will perform these activities with Patient 2 at each
visit. With respect to HCFA's claim that Patient 2's nursing home care plan does not indicate that ROM would be provided by the hospice HHA, I agree. The nursing home care plan in question states, among other things, "ROM exercises to all extremities by RNA [restorative nursing aide]." HCFA Ex. 6 at 34. In its brief, HCFA contends that "the nursing home had its own contradictory plan for ROM and was performing its own ROM on the patient." HCFA Br. at 137. I am not persuaded by HCFA's arguments. As I did with Patient 4, I conclude that the fact that ROM orders are contained in two different care plans does not, in and of itself, constitute noncompliance with 42 C.F.R. � 418.58(c). Moreover, as was the case with Patient 4, there was no showing by HCFA that these allegedly contradictory ROM orders failed to meet the needs of Patient 2 in accordance with the applicable portion of 42 C.F.R. � 418.58. I wish to reiterate that 42 C.F.R. � 418.58(c), the regulation at issue, states, in part, that the hospice plan of care "must state in detail the scope and frequency of services needed to meet the patient's and family's needs." HCFA's argument that the duration, scope and frequency of ROM is not documented (see also HCFA Br. at 137) is similar to the one it made concerning the ROM interventions contained in Patient 4's Home Health Aide/Homemaker Request form and Home Health Aide/Homemaker Notes (discussed above). The conclusions I made with respect to those documents apply here as well.As I stated above in my discussion of Patient 4, the plain language of 42 C.F.R. � 418.58(c) does not mention ROM orders specifically nor does it state what must be contained in ROM orders. With respect to the scope requirement, I reach the same conclusion that I did with Patient 4. I find that the fact that Patient 2's Home Health Aide/Homemaker Note indicates that Patient 2 would be receiving active and passive ROM sufficiently addresses the scope of the ROM activities. With respect to frequency, I note that although Patient 2's Home Health Aide/Homemaker Note does not indicate the number of weekly visits the home health aide will make, there is other hospice care plan documentation in Patient 2's medical record which indicates that the home health aide was to visit Patient 2 two to three times a week. See HCFA Ex. 6 at 2, 4, 62. As with Patient 4, discussed above, the frequency of the ROM exercises can reasonably be inferred from the number of weekly visits made by the home health aide. If the home health aide is visiting Patient 2 two to three times a week, then this would reasonably indicate that Patient 2 is receiving ROM exercises two to three times a week. Thus, contrary to HCFA's allegation in the SOD, the frequency of the ROM intervention is apparent in Patient 2's hospice care plan documentation. Further, as I noted earlier, 42 C.F.R. � 418.58(c) does not contain any requirement that the hospice care plan must state the "duration" of services needed to meet the patient's and family's needs. It is true that the hospice care plan for Patient 2 does not mention the duration of the ROM intervention. However, this failure to mention the duration has no bearing on my analysis. Moreover, there was no showing by HCFA that the ROM activity
provided to Patient 2 was either inadequate or in excess of what she needed,
or that the hospice failed to meet the ROM needs of Patient 4 in accordance
with 42 C.F.R. � 418.58(c).
With respect to Patient 9 under Tag L137, HCFA alleges
in the SOD that there is a deficiency based on the following: Patient
2's care plan #2 for comfort "did not specify the reason for giving Roxanol"
and the patient's care plan #10 for skin/mucous membrane "failed to identify
the affected area" for the use of Calmoseptine cream. See HCFA
Ex. 1 at 24. I find that HCFA's allegations relating to Patient 9 are
without support in the record and do not demonstrate noncompliance with
42 C.F.R. � 418.58(c). With respect to the use of Roxanol, the evidence indicates
that, on June 1, 1999, the hospice nurse stated in a nursing note that
Patient 9 had complaints of chest area pain as a result of a chronic cough
and contacted the attending physician, who ordered 5 mg. of Roxanol. P.
Ex. 9 at 45; HCFA Ex. 13 at 67. That same day, Patient 9's care plan #2
for comfort was updated with the intervention that 5 mg. of Roxanol was
to be given orally every four hours as needed. P. Ex. 9 at 9; HCFA Ex.
13 at 16. The intervention for Roxanol had been approved by the interdisciplinary
group. Id. The hospice points out that the order for Roxanol was
also added to Patient 9's medication list, which stated that Roxanol was
being administered for the symptom of physical pain. P. Ex. 9 at 4; HCFA
Ex. 13 at 9. The hospice asserts that, under its written care plan policy,
the medication list is considered to be part of the plan of care (P. Ex.
30 at 3); thus, contrary to HCFA's allegation, the reason for using Roxanol
is specified in Patient 9's care plan via its inclusion in the medication
list. HCFA attempts to argue that it is not clear whether Roxanol was ordered for Patient 9's pain or coughing. HCFA Br. at 139 - 140. HCFA contends that the team goal and patient/family expectations, as stated in the January 22, 1999 Comfort Care Plan, both relate to pain, but that a registered nurse informed the surveyor that the Roxanol was being given for Patient 9's cough. HCFA Ex. 13 at 15; HCFA Ex. 1 at 24. HCFA argues that the intervention did not contain information pertaining to the scope and frequency of the use of Roxanol in relation to either the pain or coughing. HCFA Br. at 139. I am not persuaded by HCFA's arguments.
Based on the record, I find no basis for HCFA's claim in the SOD that
Patient 9's comfort care plan did not give the reason for using Roxanol.
The June 1, 1999 nursing note mentions that the patient is experiencing
chest area pain due to chronic cough (P. Ex. 9 at 45; HCFA Ex. 13 at 67),
and Patient 9's medication list states that Roxanol was for physical pain
(P. Ex. 9 at 4; HCFA Ex. 13 at 9). The nursing note, at the top, states
"Plan of Care File," and the patient's medication list is, according to
the hospice's care plan policy, part of the "working care plan file."
See P. Ex. 30 at 3. Thus, both of these documents are part of Patient
9's care plan. Finally, even if HCFA had established that the intervention for Roxanol was inadequately care-planned, there was no showing by HCFA that the care provided to Patient 9 by the hospice was inadequate or that the hospice failed to meet the needs of Patient 9 in accordance with 42 C.F.R. � 418.58(c). With respect to the intervention for Calmoseptine cream, HCFA contends that Patient 9's care plan failed to identify the affected area on which the cream was to be used, in violation of the scope requirement of 42 C.F.R. � 418.58(c).(18) According to Ms. Poolsawat, the hospice should have stated the specific location of the body where the Calmoseptine cream was to be applied. Tr. 1690. Patient 9's interdisciplinary care plan update, dated May 27, 1999, concerns the intervention for Calmoseptine cream. It is noted on this update that the intervention is related to a "rash." HCFA Ex. 13 at 39. The intervention is written as follows: "Calmoseptine crm [cream] bid [twice a day] & prn [as needed] to affected area. Husband instructed on use of med." Id.On May 27, 1999, the prescribing physician ordered the discontinuation of Miconazole cream to the "affected area." He further ordered that Calmoseptine cream was to be applied twice a day and as needed. The term "affected area" was thus used by the prescribing physician himself. P. Ex. 37 at 6; Tr. 1714 - 1715. Thus, it was appropriate for the nurse to use the same language, "affected area," as the prescribing physician had. The hospice asserts that there is documentation elsewhere in Patient 9's record which indicates where the "affected area" is. The hospice states that the Plan of Care Case Conference Summary for the period May 27, 1999 - June 10, 1999, documents that Patient 9 had a rash to the bilateral thigh area, and indicates also that the interdisciplinary group approved Calmoseptine ointment as a new medication for Patient 9. P. Ex. 9 at 6. The hospice also points out that a nursing note dated May 21, 1999, documents that the patient had a "rash between thighs." Id. at 34. The hospice states further that Patient 9's medication list contains Calmoseptine and indicates that it is to be used for the symptom of rashes. HCFA Ex. 13 at 10. Based on these notations, the hospice argues that it is apparent that Calmoseptine cream will be used to resolve Patient 9's rash, which is located in the bilateral thigh area. Moreover, the frequency for application of Calmoseptine cream is specified as being twice a day and as needed. P. Br. at 166. I agree with the hospice that Patient 9's care plan satisfies the scope and frequency requirements with respect to the use of Calmoseptine cream. As previously discussed, under the hospice's care plan policy, several types of documents have been designated by the hospice as collectively comprising a patient's care plan. See P. Ex. 30 at 3. These documents include the care plan, any Interdisciplinary care plan forms, medication list, Home Health Aide/Homemaker Request, and the Case Conference Summary. There is no requirement in the regulations that a patient's care plan must be comprised of only one document. Here, Patient 9's interdisciplinary care plan update (HCFA Ex. 13 at 39) and medication list mention her rash and detail the frequency for applying Calmoseptine cream (HCFA Ex. 13 at 10). Her Case Conference Summary documents that Patient 9 had a rash to the bilateral thigh area. These documents together contain adequate information regarding the scope and frequency for applying Calmoseptine cream. I note also that, on cross-examination, HCFA's witness, Ms. Poolsawat, admitted that Patient 9 had a rash and that the Calmoseptine cream was to be applied to the rash. Tr. 1705 - 1706. Moreover, she conceded that the Case Conference Summary does indicate where Patient 9's rash is. Tr. 1708. The evidence is insufficient to show that the hospice failed to state the scope and frequency of the services for Patient 9, as required under 42 C.F.R. � 418.58(c). I find that HCFA has failed to establish a prima facie basis for this alleged deficiency under Tag L137.
The hospice's alleged noncompliance with the
condition found at 42 C.F.R. � 418.52 (Tag L107) HCFA alleged that in June 1999, the hospice had a condition-level
deficiency in meeting the Governing Body requirements (the hospice's alleged
noncompliance with Tag L107). The Governing Body requirements are found
in the regulations at 42 C.F.R. � 418.52 (condition of participation --
Governing body).
HCFA based the condition-level deficiency (Tag L107),
on one standard (Tag L108), that requires the following:
HCFA Ex. 1 at 1 - 2. I quote verbatim the SOD allegations to illustrate the absence of even alleged evidence to support the alleged violation of 42 C.F.R. � 418.52. HCFA alleged no specific evidence and, at the hearing, presented no specific evidence, to prove that the hospice failed to have a governing body "that assumes full legal responsibility for determining, implementing and monitoring policies governing the hospice's total operation." Rather, HCFA theorized that the hospice failed to comply with the condition for Plan of Care at 42 C.F.R. � 418.56, and that, consequently, the condition for Governing Body was not met. Tr. 1466; HCFA Br. at 162. HCFA based the alleged condition-level Governing Body deficiency solely on alleged noncompliance with the
Plan of Care requirements for participation,(19)
which HCFA failed to prove. See discussion supra. HCFA's allegation reads as follows in the SOD: This is HCFA's allegation in its entirety, that the hospice's governing body was deficient. The allegation relies on the evidence of the alleged plan of care deficiencies. HCFA's theory became more clear with the testimony of Cdr. Sadovich and HCFA's post-hearing brief. Cdr. Sadovich explained that the governing body is "responsible to make sure that they know what is required by the regulations, and then set up their operation to be in compliance with the regulations through their policies and procedures, and making sure that those policies and procedures are not only written in a form that would be in compliance, but indeed are implemented in a manner that would be in compliance, and that . . . the hospice is functioning in a manner that is consistent with compliance." Tr. 1467; HCFA Br. at 162. I agree with that analysis by Cdr. Sadovich. Her testimony that the condition for Governing Body requires more than that the hospice have a governing body is consistent with the governing body regulation. Cdr. Sadovich testified that the condition "requires that the governing body assume responsibility for the total operation of the hospice, that they are ultimately the responsible party for what occurs in that hospice." Tr. 1465 - 1466; HCFA Br. at 161 - 162. Again, that testimony is consistent with the regulation. I do not agree, however, with HCFA's assertions that it proved a Plan of Care condition-level deficiency (the hospice's alleged noncompliance with Tag L132). HCFA stated that it is clearly authorized in finding the Governing Body condition deficient where a condition such as Plan of Care, that addresses the very foundation of the care furnished to the hospice's patients, is found not met. HCFA continued by saying that it is the governing body that is ultimately responsible for plans of care as part of its total responsibility, and if deficient practices led to the hospice's failure to meet the condition for Plan of Care, then the governing body had not carried out its responsibility for ensuring compliance, and the condition for Governing Body was therefore not met. HCFA Br. at 162 - 163. HCFA concludes, "Accordingly, it is submitted that because HCFA presented a prima facie case that the Condition of Participation for Plan of Care was not met at the time of the June 1999 second revisit survey, HCFA has also presented a prima facie case that it was authorized determining the Condition for Governing Body was also not met." Id. at 163. HCFA's theory that the hospice had a condition-level deficiency in meeting the Governing Body requirements fails, however, based on the evidence. I find that the evidence did not show a deficiency concerning the hospice's governing body. Rather, since HCFA failed to establish a prima facie case that the hospice was out of compliance with the Plan of Care hospice condition of participation, that evidence also failed to establish a prima facie case that the hospice was out of compliance with the Governing Body hospice condition of participation. I conclude that HCFA failed to prove that the hospice was deficient in meeting the Governing Body condition of participation (Tag L107), and HCFA failed to prove that the hospice was deficient in meeting the Governing Body standard (Tag L108). HCFA Ex. 1 at 1 - 2; Tr. 1467 - 1468; HCFA Br. at 161 - 163; P. Br. at 50 - 56. Each allegation was entirely dependent on proof that the hospice was out of compliance with the Plan of Care hospice condition of participation. As shown above, in subsection V.A. of this Decision (the Plan of Care subsection), the evidence failed to sustain HCFA's allegations. Thus, HCFA failed to establish a prima facie case that the hospice was out of compliance with the Governing Body hospice condition of participation, as alleged under Tag L107.
HCFA alleges that there is a standard-level deficiency
based on the hospice's alleged noncompliance with Tag L124 - 42 C.F.R.
� 418.56(c) (Standard -- Professional management responsibility). This
regulation governs arrangements that hospices make for another individual
or entity to furnish services for Medicare beneficiaries whose care they
manage. The hospice's alleged noncompliance with the standard found at 42 C.F.R. � 418.56(c) (Tag L124)
The SOD, under Tag L124, alleges the violation of 42 C.F.R.
� 418.56(c) at the standard level. Before discussing the SOD's alleged
findings, I must first address the issue of whether HCFA provided the
hospice with adequate notice of its findings relating to this Tag. The
SOD alleges failure to retain professional management responsibility for
five "hospice patients residing in a nursing home," but the SOD provides
information concerning only two patients, Patients 2 and 4. HCFA Ex. 1
at 3 - 7. The hospice protests HCFA's attempt to inject issues not
specifically alleged in the SOD, and has maintained such protest in its
hearing request (P. Hearing Req. at 7), at the hearing, and post hearing.
Despite the hearing request written notice to HCFA regarding the lack
of notice in the SOD, HCFA failed to provide any more specific statement
of the alleged deficiencies to the hospice prior to the hearing. HCFA
did not provide the hospice with any supplemental notice, of evidence
or issues, that would be adequate to permit HCFA to proceed with additional
allegations. For the reasons articulated in the hospice's brief (P. Br.
at 57 - 60, 66 - 68, 73 - 76, 81 - 82, 85 - 88), HCFA will be confined
to its allegations regarding Patients 2 and 4 in attempting to establish
its prima facie case, and to only the allegations made in the SOD. The
hospice's motion, to have stricken from consideration any evidence submitted
by HCFA regarding alleged deficiencies which are not specifically cited
in the SOD (Id.), is hereby granted. Specifically, I disregard
any evidence in the SOD or from the hearing regarding alleged deficiencies
for Patients 1, 3, and 5 under Tag L124. I also disregard any evidence
in the SOD or from the hearing regarding alleged deficiencies regarding
Patients 2 and 4 under Tag L124 which are not specifically cited in the
SOD. Even the remaining allegations are problematic, for the reasons argued by the hospice. P. Br. at 57 - 92. I agree with the hospice that the allegations that purport to support a finding of deficiency under Tag L124 are vague, contradictory and also difficult to respond to. Further, I agree with the hospice that the regulation [42 C.F.R. � 418.56(c)] does not require "integration" of the plans of care of the two providers, the hospice and the skilled nursing facility. Rather, the regulation focuses on the services being provided to the patients, and the hospice's responsibility to ensure that those services are furnished in a safe and effective manner. I find no evidence that the hospice failed to fulfill that responsibility. See also supra the discussion under Tag L137 concerning Patient 4, regarding "integration," with the caveat that professional management responsibility is separate and distinct from care planning. P. Br. at 63 - 65; see also Tr. 1048 - 1057.
Patient 2's care has already been addressed under Tags L133 and L137. Her comfort management included the discontinuation of monthly laboratory work and blood pressure control with Lopressor, in accordance with the physician's orders. She received range of motion exercises and wore a physician-ordered right hand splint. Her nutrition needs were addressed in part by a gastrostomy tube feeding of Isosource HN with interventions of checking blood sugar daily, with regular insulin coverage, and using Compazine to treat nausea and vomiting. The alleged deficiency here, under Tag L124, is that "the hospice plan of care was not integrated with the nursing home's plan of care." HCFA Ex. 1 at 4. HCFA's theory, as stated in the SOD under Tag L124, that the hospice plan of care must be integrated with the nursing home's plan of care, is not required by the regulation. HCFA presented no evidence that the care and services provided to Patient 2 were other than as required under 42 C.F.R. � 418.56(c), that is, "furnished in a safe and effective manner by persons meeting the qualifications of this part, and in accordance with the patient's plan of care and the other requirements of this part." For the reasons stated in the hospice's brief (P. Br. at 60 - 80), and based upon my conclusions under Tags L133 and L137 concerning Patient 2's care, I find no evidence that the hospice failed to fulfill its professional management responsibility for services to Patient 2 under Tag L124.
Patient 4's care has already been addressed under Tags
L133, L136, and L137. She is the nonverbal patient with dementia, dysphagia,
and anorexia, whose anxiety manifested by kicking was treated in part
by Risperdal, whose pain was addressed in part by the Lortab elixir, and
who had range of motion activity. Patient 4 was being fed a pureed diet
with no concentrated sweets; eight ounces of high protein nourishment,
in-between-meals, three times a day; and a multi-vitamin, vitamin C, and
zinc, in order to assist metabolism. The alleged deficiency here, under
Tag L124, is that the hospice plan of care was not integrated with the
nursing home's plan of care. See HCFA Ex. 1 at 7. HCFA's theory,
as stated in the SOD under Tag L124, that the hospice plan of care must
be integrated with the nursing home's plan of care, is not required
by the regulation. HCFA presented no evidence that the care and services
provided to Patient 4 were other than as required under 42 C.F.R. � 418.56(c),
that is, "furnished in a safe and effective manner by persons meeting
the qualifications of this part, and in accordance with the patient's
plan of care and the other requirements of this part." For the reasons
stated in the hospice's brief (P. Br. at 60 - 65, 80 - 92), and based
upon my conclusions under Tags L133, L136, and L137 concerning Patient
4's care, I find no evidence that the hospice failed to fulfill its professional
management responsibility for services to Patient 4 under Tag L124. The hospice's alleged noncompliance with the
standard found at 42 C.F.R. � 418.74 (Tag L176) TheSOD, under Tag L176, alleges the violation of 42 C.F.R. � 418.74, which states:
The SOD contends that, for two of nine patients, "the registered nurse failed to accurately document the patient's condition and the treatment rendered." HCFA Ex. 1 at 24 - 25. Following this allegation is a recitation of the situations concerning two of the hospice patients: Patients 8 and 9. Id. at 25.
With respect to Patient 8, the SOD alleges that the registered
nurse had documented conflicting information in a nursing note dated May
25, 1999. HCFA contends "For example, the registered nurse documented
in the pain assessment section as [sic] "patient denied pain. Patient
stated pain in the right great toe." HCFA Ex. 1 at 25. I do not find that the May 25, 1999 nursing note contained
any conflicting information. For this reason, there is no basis to support
a finding that the hospice was out of compliance with the standard under
Tag L176. In the May 25, 1999 nursing note, there is a statement by the registered nurse in the Pain assessment section that the "Pt. [patient] denies pain." This statement is crossed out with a single line and the word "error" is written above it, with the nurse's initials circled beside it. HCFA Ex. 12 at 24. Following this statement, the nurse wrote that the "Pt. states pain in great toe of R [right] foot . . . ." Id. The hospice asserts that the nurse clearly marked the first statement about the patient denying pain as an error, and then correctly indicated in her next statement that the patient was experiencing pain in his toe. As further support of this interpretation of the nurse's written comments, the hospice points to the "Summary" section of the May 25, 1999 nursing notes, which state:
Id. at 26. The nurse had also noted in the "New
Symptoms" section that Patient 8 had a "pink, warm, slightly swollen toe."
Id. Based on the aforementioned documentation, I conclude
that the medical record for Patient 8 shows complete and accurate documentation
of his toe pain. Moreover, on May 26, 1999, according to a supplemental
interdisciplinary note, the hospice nurse wrote that she called the patient
at his home. The patient stated that he had seen a physician regarding
his toe, and the physician had prescribed Keflex, Lotrimin lotion, and
foot soaks. HCFA Ex. 12 at 23. That same day, Patient 8's interdisciplinary
care plan was updated to document the interventions for his "inflamed
toe." Id. at 40. Thus, it is evident that Patient 8's toe pain
was monitored and accurately documented. There is nothing to indicate
that the information in the record regarding Patient 8's toe pain was
conflicting or inconsistent. Based upon her testimony, it is apparent that Ms. Poolsawat
misread the May 25, 1999 nursing note and did not notice that the nurse
had written "error" over her first statement regarding the patient's denial
of pain. Ms. Poolsawat did not dispute that the May 25, 1999 nurse's note
indicated that the patient had pain in his toe. Tr. 1727. When asked if
the nurse "accurately documented that the patient had toe pain on 5/25,"
Ms. Poolsawat responded, "It appears so." Tr. 1728. She admitted on cross-examination
that it was "clear" in looking at the nursing note that the nurse crossed
out the phrase "Patient denies pain" and then wrote "Error" and her initials.
Tr. 1731. When asked if this was an "appropriate correction of her error,"
Ms. Poolsawat responded "Yes." Id. She admitted that the nursing
notes document that the nurse did call the physician and received instructions
from the physician for the patient. Tr. 1727, 1728. Further, Ms. Poolsawat
conceded that Patient 8's toe pain was treated by a physician. Tr. 1742. At the hearing, Ms. Poolsawat appeared to allege other bases not mentioned in the SOD on which to support a finding that Patient 8's medical record contained conflicting information. Tr. 1732, 1734, 1735, 1737. For example, Ms. Poolsawat claimed that Patient 8's care plan was inaccurate and also, that the hospice nurse had written a zero on the left-hand side of the pain section to indicate the level of pain severity, and this was "confusing." See Tr. 1735, 1737, 1741 - 1742. However, in the SOD, Ms. Poolsawat did not allege that Patient 8's care plan contained inaccuracies nor did she mention the zero written in the pain section. I will not consider these new allegations that were raised for the first time at the hearing, of which HCFA had given the hospice no notice. I conclude that the evidence does not support a finding that the standard under Tag L176 was not satisfied with regard to Patient 8. I find that HCFA has failed to establish a prima facie basis for this alleged deficiency.
HCFA alleges in the SOD that a review of the nursing notes
for Patient 9 from May 20, 1999 to June 14, 1999 "revealed the registered
nurse repeatedly documented in the pain assessment section that the patient
denied pain and discomfort, but the patient was given Darvocet one to
three tablets per 24 hours." HCFA contends further that, during a home
visit on June 22, 1999, the registered nurse told the surveyor that Darvocet
was given for pain in the patient's stomach. HCFA Ex. 1 at 25. I do not agree with HCFA that the nursing notes in question
contain conflicting information concerning whether or not Patient 9 was
experiencing any pain. I do not find that the hospice nurse maintained
inaccurate documentation regarding Patient 9's pain. Patient 9's interdisciplinary care plan for comfort contains
an intervention to administer Darvocet for physical pain. HCFA Ex. 13
at 15; See Id. at 7. According to this care plan, the patient's
husband was to be taught to assess her pain according to the non-verbal
pain scale and to give her Darvocet, as needed, for the pain. The team
goal was for the patient's pain to be at a level 3 or lower on the non-verbal
pain scale of 0 to 10. HCFA Ex. 13 at 15. Additionally, at each visit,
the nurse was instructed to monitor the patient's pain level, evaluate
the effectiveness of Darvocet, and monitor the number of doses given.
Id. I find that the fact that Patient 9 was receiving Darvocet for pain is not inconsistent with the other documentation in the nursing notes stating that she was not experiencing any pain at the time of the nurse's visit. As stated above, the team goal for Patient 9 was that her pain would be kept at a level of 3 or below on the nonverbal pain scale. To achieve this team goal, the intervention to administer Darvocet, as needed, was approved by the interdisciplinary team. As instructed, the hospice nurse assessed the effectiveness of the medication at each visit; based on the documentation in the nurse's notes dated May 20, May 21, May 24, and May 28, 1999 (HCFA Ex. 13 at 45, 48, 56, and 62), the patient must have experienced pain above the target level on occasion, since the patient and/or her caregiver reported the doses of Darvocet she took during the day. Further, one would expect the patient's pain to be eliminated if she was receiving doses of Darvocet. Thus, it is entirely likely and logical that Patient 9 would not have any complaints of pain or discomfort at the time of the nurse's visit and, in fact, the aforementioned nursing notes reflect that Patient 9's pain was under control at the time of these visits. When asked about the nurse's May 28, 1999 visit, Ms. Poolsawat conceded on cross-examination that the nurse's notation that the patient is not having any pain would indicate that the patient is not having any pain at the time of the nurse's visit. HCFA Ex. 13 at 62; P. Ex. 9 at 40; Tr. 1759 - 1760. Thus, I conclude that there is no conflicting information in the nursing notes for Patient 9.(20) Moreover, the nurse did not complete the pain assessment
section in the nursing notes without input. The nurse's written notations
concerning the patient's pain level were based on the information she
obtained from the patient and/or her caregiver at the time of her visit.
For the visit of May 20, 1999, the nurse's notation was "0/10," "Denies
any pain discomfort," and "x3 Darvocet in the last 24 [hours]." HCFA Ex.
13 at 45. For the visit of May 21, 1999, the nurse's notation was "0/10,"
"Denies any c/o [complaint of] pain," and "x2 Darvocet in the last 24
[hours]." Id. at 48. For the visit of May 24, 1999, the nurse's
notation was "0/10," "Denies any c/o [complaint of] acute pain discomfort,"
and "x2 Darvocet in the last 24 [hours]." Id. at 56. For the visit
of May 28, 1999, the nurse's notation was "0/10," "Denies any acute pain
discomfort," and "x2 Darvocet in the last 24 [hours]." Id. at 62.
For the visit of June 1, 1999, the nurse's notation was that the severity
of the patient's pain was "2/10" on the non-verbal pain scale, that the
location of her pain was the "lung chest area," that the provocation was
"cough," that the palliation was "Darvocet," and "x3 Darvocet in the last
24 [hours]." Id. at 65. Patient 9's terminal diagnosis was end
stage chronic obstructive pulmonary disease, so her lung and chest area
pain from coughing is understandable. Id. at 1. In addition, Patient 9 had difficulty swallowing and had a gastrostomy tube (PEG tube). Id. at 24. The nurse reported to Ms. Poolsawat that the patient was receiving Darvocet for stomach pain. HCFA Ex. 1 at 25. I do not find the nurse's report to be inconsistent with Patient 9's denials of pain documented in the nursing notes, for the reasons stated above. Based on the evidence, it does not appear that the hospice staff have inaccurately documented Patient 9's pain. I conclude that the evidence does not support a finding that the standard under Tag L176 was not satisfied with regard to Patient 9. I find that HCFA has failed to establish a prima facie basis for this alleged deficiency. The hospice's alleged noncompliance with the
standard found at 42 C.F.R. �
418.74(a)(6) (Tag L185) In the SOD, under Tag L185, HCFA alleges the violation of 42 C.F.R. � 418.74(a)(6). HCFA Ex. 1 at 25. The regulation states as follows:
42 C.F.R. � 418.74(a)(6). The SOD contends that "Based on clinical record review, the Hospice failed to ensure each individual's clinical record contains progress notes." HCFA Ex. 1 at 26. The SOD then describes a progress note of Patient 8, dated June 4, 1999, and alleges that it "fails to include a summary of all care and services by discipline as required by the hospice policy and training." Id. at 26 - 27. HCFA's main contention appears to be that the June 4,
1999 progress note for Patient 8 does not contain all the information
as required by the hospice internal policy for progress notes. HCFA asserts
that the hospice policy states that all progress notes must contain a
summary of all care and services by discipline, and that Patient 8's progress
note is deficient in this respect. HCFA Ex. 1 at 26 - 27. The hospice's alleged noncompliance with the
standard found at 42 C.F.R. � 418.96 (Tag L213)
The SOD alleged a standard-level deficiency based on the hospice's alleged noncompliance with Tag L213 - 42 C.F.R. � 418.96 (Standard -- Medical Supplies). HCFA Ex. 1 at 27 - 31. HCFA maintained that the hospice failed to ensure that medical supplies were provided as needed for the palliation and management of the terminal illness for eight of the nine sampled patients. HCFA Ex. 1 at 27 - 28. Specific examples are cited in the SOD for only six of the referenced patients: Patients 1, 5, 3, 2, 4, and 7. HCFA did not provide notice to the hospice that would be adequate to permit HCFA to proceed with any additional allegations, so HCFA will be confined to its allegations regarding only the six patients, and to only the allegations made in the SOD. HCFA argues that, if a hospice includes a medication in a patient's plan of care or on the medication list, the hospice thereby becomes required to pay for or procure that medication, even when the medication is utilized for an illness that is not the terminal illness (that made the patient eligible for hospice) or a related condition. Tr. 1444, 1448 -1449. I can make no sense of HCFA's reasoning. Perhaps HCFA wants to simplify the review process for the surveyors. Their review can be kept from becoming complicated, by having the hospice enter nothing on the medication list except those medications and other medical supplies that the hospice would pay for and procure. I find, however, that the hospice's objective, of ensuring that fully informed caregivers will serve the patient, is far more significant.Furthermore, the hospice records clearly delineated which medications and other medical supplies the hospice would pay for, and which it would not. The distinction was readily available to surveyors and they understood it. Cdr. Sadovich stated that the system was explained to her. Tr. 1460 - 1461. "Not hospice approved" was the designation on the medication list that showed that the hospice was not paying for the item. A patient becomes eligible for hospice care because of a terminal illness that gives the patient a life expectancy of no more than 6 months. When the hospice accepts responsibility for the care of that patient, the hospice is required to direct all the care, not just the care related to the terminal illness. The hospice must therefore keep abreast of all the patient's conditions, in part, to "do no harm," and, in part, to keep the patient comfortable. The regulation does not define the word "provide." HCFA employee Ms. Mavis Connolly, a technical director in the Center for Medicaid and State Operations in the Continuing Care Providers Branch, testified that she understood the phrase "must be provided as needed,"as contained in 42 C.F.R. � 418.96, to mean that "[t]hey need to make sure the patient receives those medications." Tr. 1043. This regulation requires only that the hospice provide those medications or medical supplies utilized for the terminal illness and related conditions. Directing the patient's care with regard to medications may require being sure the patient has the medications, but may not require procuring the medications or paying for the medications. The surveyors determined, based on their review of clinical records and interview with hospice staff, that any medication or other medical supply in a patient's plan of care or on the medication list was to be paid for by the hospice, regardless of whether it was utilized for the terminal illness or related conditions. The surveyors considered deficient the hospice's policy not to pay for or procure certain medications and other medical supplies, even though not utilized for the terminal illness or related conditions, if they were on the medication list or in the plan of care. This was an error on the part of the surveyors. One by one, I address the six patients, Patients 1, 5, 3, 2, 4, and 7, for whom HCFA alleged deficiencies. In each case, I determine whether the medications or medical supplies were utilized for the terminal illness or related conditions.
The terminal diagnosis which made Patient 1 eligible for
hospice is "cerebral degeneration (dementia) except Alzheimer's." HCFA
Ex. 4 at 1. The medications that HCFA claims the hospice should pay for,
aspirin (aspirin therapy), digoxin (cardiac function), Prilosec (gastric
distress), Propulsid (gastric distress), Reglan (gastric distress), regular
insulin (Diabetes Mellitus), and NPH insulin (Diabetes Mellitus), were
not utilized for the terminal illness or related conditions. Consequently,
I find that the hospice was not required to pay for or procure those medications.
In managing and directing the patient's overall care, the hospice may
ensure that the patient is provided with all medications and medical supplies
and appliances that the patient needs, but the same may be paid for or
procured from sources other than the hospice. When the hospice chose to
include on the medication list, or in the plan of care, medications that
were not for the terminal illness or related conditions, that choice did
not subject the hospice to paying for or procuring all such acknowledged
medications. The hospice was entitled to use the medication list, and
the plan of care, to stay aware of a patient's medications, even those
not for the terminal illness (that made the patient eligible for hospice)
or related conditions. In that way the hospice could better monitor the
impact and the interaction of a patient's medications. The hospice is
correct in asserting that entering a medication or other medical supply
on the medication list or in the plan of care does not require a hospice
to pay for or procure a medication utilized for an illness that is not
the terminal illness or a related condition. P. Br. at 174 - 182; P. R.
Br. at 133 - 139.
The terminal diagnosis which made Patient 5 eligible for hospice is "neoplasm of the large intestine (colon cancer)." HCFA Ex. 9 at 1. The medications that HCFA claims the hospice should pay for are aspirin and Cardura. Neither the aspirin nor the Cardura was utilized for the terminal illness or related conditions, nor did they become related to the terminal illness by being placed on the medication list or in the plan of care. Consequently, I find that the hospice was not required to pay for or rocure those medications. The findings applicable to Patient 1 above apply here as well.
The terminal diagnosis which made Patient 3 eligible for
hospice is "end stage cerebrovascular disease." HCFA Ex. 7 at 20. The
medication that HCFA claims the hospice should pay for is Prevacid. The
Prevacid was not utilized for Patient 3's terminal illness or related
conditions. The Prevacid does not become related to the terminal illness
by being placed on the medication list or in the plan of care. Consequently,
I find that the hospice was not required to pay for or procure the Prevacid.
The findings applicable to Patient 1 above apply here as well.
The terminal diagnosis which made Patient 2 eligible for hospice is "end stage Alzheimer's disease." HCFA Ex. 6 at 1. The medications that HCFA claims the hospice should pay for are Lopressor (hypertension) and Insulin Regular Pork (glucose management). The Lopressor was prescribed for comfort management, which is not related to the terminal illness or related conditions. The insulin was prescribed for Patient 2's blood sugar management, which is not related to the terminal illness or related conditions. Consequently, I find that the hospice was not required to pay for or procure those medications. The findings applicable to Patient 1 above apply here as well.
The terminal diagnosis which made Patient 4 eligible for hospice is "cerebral degeneration (dementia) except Alzheimer's." HCFA Ex. 8 at 1. The medications that HCFA claims the hospice should pay for, Insulin NPH Purified (hypoglycemia) and Glucagon (blood glucose management), were not utilized for the terminal illness or related conditions. Neither the Insulin NPH Purified nor the Glucagon became related to the terminal illness by virtue of being included in the patient's overall management. Consequently, I find that the hospice was not required to pay for or procure those medications. The findings applicable to Patient 1 above apply here as well.
The wrong patient was cited in the SOD. It was not Patient
6 for whom the items were unavailable; it was Patient 7. P. Br. at 179
- 180. The hospice objected to my considering this allegation at the hearing,
and has since moved to strike the evidence I allowed in, over its objection.
Tr. 1768 - 1769; P. Br. at 180. At the hearing, I found that the error
in the SOD was overcome by the detail contained in the same section of
the SOD, where there were also two references to Patient 7. Tr. 1770;
HCFA Ex. 1 at 30 - 31. Consequently, I reaffirm my determination that
HCFA had provided adequate notice of this patient's identity. The hospice's
motion to strike is denied. The terminal diagnosis which made Patient 7 eligible for
hospice is ALS. HCFA Ex. 11 at 1. Patient 7 received hospice care at her
home. The medications or supplies that HCFA claims the hospice should
pay for, Tucks medicated pads and Preparation H for hemorrhoids, appeared
on the medication list, but the hospice was not paying for them. The Tucks
and Preparation H were not utilized for the terminal illness or related
conditions. Consequently, I find that the hospice was not required to
pay for or procure those medications. The findings applicable to Patient
1 above apply here as well. Additionally, there were medications on the medication
list or in the plan of care that were not in Patient 7's home during a
home visit: Klonopin for muscle spasm, Sorbitol for constipation, Immodium
A-D for diarrhea, acetaminophen for symptoms of fever/chills, and Compazine
for symptoms of nausea/dry heaves. Patient 7's medication list had a total
of 17 medications to be given as needed for symptom relief. HCFA Ex. 1
at 30. Initially I found it troubling that five "as needed" medications
were not available to the patient (i.e., not in the home), regardless
of whether the hospice was responsible to pay for them. The evidence persuaded
me, however, that the patient had no current need for the items. Patient
7 told the surveyor, Ms. Garces, that those medications had expired and
she did not need them. Tr. 1783 - 1784. The hospice could have eliminated
the confusion here by making an entry such as "not currently needed" on
the medication list, but there was no such documentation. Nevertheless,
HCFA failed to prove that the missing medications were "needed
for the palliation and management of the terminal illness and related
conditions." (emphasis added). I find that the SOD allegations and HCFA's evidence failed
to establish a prima facie case of any medical supplies deficiency under
Tag L213. HCFA did not show any failure by the hospice to comply with
42 C.F.R. � 418.96.
There is no need for me to consider any evidence from
the March 1999 survey because it is irrelevant. The March 1999 survey
evidence is irrelevant because HCFA, in its discretion, permitted the
hospice the opportunity to establish compliance with the Medicare conditions
of participation by the time of the second resurvey (3rd survey)
which was completed on June 23, 1999. HCFA Ex. 2. The June 1999 survey
evidence does not show that the hospice failed to establish compliance.
Not only does that evidence fail to show non-compliance with any condition
of participation, that evidence fails also to show non-compliance with
any standard. The foregoing discussion, in sections V.A., V.B., and V.C., demonstrates that at the time covered by the June 1999 survey, the hospice had no deficiencies that would justify termination. After careful consideration of the evidence, I found no support in the evidence for any of HCFA's alleged deficiencies. I found three insignificant documentation omissions, none of which constituted even a standard-level deficiency. Those three insignificant documentation omissions are discussed under Tag L133, involving Patient 7, Patient 8, and Patient 9. In each case, there was no evidence that the hospice failed to establish and maintain a written plan of care for the patient, and there was no evidence that the hospice failed to provide care in accordance with the plan, as required by 42 C.F.R. � 418.58. The circumstances of Patient 9 were alleged again under Tag L136. Here again, there was no evidence that the hospice failed to assess the patient's needs or to identify and provide services to meet those needs, as required by 42 C.F.R. � 418.58. I found none of the three insignificant documentation omissions was proven to have affected or even to have had the potential to have affected the care and services provided to the patient I find that HCFA did not establish a prima facie case that, at the time covered by the June 1999 survey, the hospice failed to establish compliance with either of the two Medicare conditions of participation (Plan of Care, Governing Body) that HCFA alleged to be deficient. I find further that HCFA did not establish a prima facie case that, at the time covered by the June 1999 survey, the hospice had any deficiencies which, noted either individually or in combination, were of such character as to substantially limit the hospice's capacity to furnish adequate care or adversely affected the health and safety of patients. 42 C.F.R. �� 488.24(b) and 488.26. Clearly, the evidence from the June 1999 survey fails to justify termination.VI. CONCLUSION HCFA did not have the authority to terminate the hospice's Medicare provider agreement. |
|
JUDGE | |
Jill S. Clifton Administrative Law Judge
|
|
FOOTNOTES | |
1. With respect to Tag L133, at the hearing, and in its post-hearing response brief, HCFA discussed only the situations relating to the specific patients identified in the SOD. HCFA did not present any evidence regarding any patients not specifically identified under Tag L133. 2. The nurse visited Patient 7 once a week. Tr. 403. 3. Failing to meet the goal would not necessarily constitute a deficiency, so long as proper and adequate care that met the patient's needs was provided. 4. These nursing notes are dated May 19, 1999, May 27, 1999, June 2, 1999, June 9, 1999, and June 16, 1999, and are the same ones which were the focus of my discussion concerning the monitoring of Patient 7's bowel movements. 5. An appeal of the decision in Libbie Convalescent Center was filed with the DAB, but before an appellate panel of the DAB could review the decision, the appeal was dismissed because the parties settled the case. 6. Throughout this Decision, I use the phrase "nursing home" interchangeably with "skilled nursing facility." 7. Cdr. Liebmann testified that Lopressor is an anti-hypertensive medication to relieve or reduce a person's blood pressure. Tr. 473. 8. In fact, during cross-examination, when asked by the hospice's counsel if any part of this alleged deficiency was based on the fact that the patient was receiving gastrointestinal tube feedings of Isosource, the surveyor replied, "No." Tr. 486 - 487. 9. Risperdal is an anti-psychotic medication. Tr. 520 - 521. 10. In its brief, HCFA argues that the hospice's "charting by exception" argument is irrelevant as to the issue of whether HCFA has come forward with a prima facie case. HCFA Br. at 73. 11. Although HCFA alleges in the SOD that there was a reddened area in Patient 9's perineal area, this appears to be a misstatement of the June 14, 1999 Home Health Aide note, which reads, in part: "reddened area on coccyx, peri area done c soap and water. . . ." HCFA Ex. 13 at 92. There was no testimony that anyone saw a reddened area in Patient 9's perineal area. 12. Respite care is defined in the regulations as "short-term inpatient care provided to the individual only when necessary to relieve the family members or other persons caring for the individual." 42 C.F.R. � 418.204(b)(1); see Tr. 1351 - 1352. 13. In the SOD, the findings under Tag L136 were misnumbered. There were five findings under the tag, two of which were numbered "(2)." 14. According to Cdr. Liebmann, the difference between active and passive ROM is that the individual can assist independently in moving the body part for active ROM, whereas in passive ROM, the individual does not participate and the aide does all of the movement for the individual. Tr. 1151. 15. The request form was approved by the IDG and acts as an order for the provision of home health aide services to the patient. 16. Based on the medical record, Patient 4 suffered from contractures. See HCFA Ex. 8 at 80. 17. See HCFA Ex. 42 at 4, which is an excerpt from the State Operations Manual. See also Tr. 1048 - 1057. 18. Ms. Poolsawat testified that Calmoseptine cream is usually used for skin irritations, such as a skin or diaper rash. Tr. 1690. 19. The Governing body tags, Tags L107 (condition-level) and L108, rely on the Plan of Care allegations, which are Tags L132 (condition-level), L133, L135, L136, and L137. [Tag L135 cites no patient examples and identifies no source of the allegations, so I dismissed Tag L135 based on inadequate notice.] 20. The SOD references the nurses' notes from May 20, 1999 - June 14, 1999, and appears to suggest that the patient was taking Darvocet throughout this period. However, the nurse's notes dated June 4, June 7, June 9, June 11, and June 14, 1999, document that Patient 9 was taking Roxanol for pain and do not mention Darvocet. HCFA Ex. 13 at 71, 77, 80, 86, and 93. In the SOD, HCFA did not mention Patient 9's usage of Roxanol with respect to this alleged deficiency. Thus, I am not considering the aforementioned nursing notes which mention Roxanol in my discussion of this alleged deficiency. I have considered only those nursing notes which documented that Patient 9 was taking Darvocet, since that is what the surveyors have focused on in their allegation. | |