Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
|||||||||||||||||||||
IN THE CASE OF | |||||||||||||||||||||
Home Nursing Services, |
DATE: August 8, 2002 | ||||||||||||||||||||
- v - |
|||||||||||||||||||||
Centers for Medicare & Medicaid
Services.
|
Docket No.C-00-752
Decision No. CR942 |
||||||||||||||||||||
DECISION | |||||||||||||||||||||
DECISION I decide as a matter of law there was no condition-level deficiency shown by the June 29, 2000 revisit and complaint survey in this case. Thus, Petitioner was in substantial compliance on June 29, 2000, and termination of Petitioner's provider agreement was unsupported and improper. The Centers for Medicare & Medicaid Services' (CMS) declaration of noncompliance and termination of Petitioner's provider agreement is therefore void. (1) I. Procedural history On June 29, 2000, the Indiana State Department of Health (ISDH) conducted a revisit and complaint survey of Petitioner. The ISDH found noncompliance with the condition of participation established by 42 C.F.R. � 484.18 related to the acceptance of patients, plan of care, and medical supervision. Based upon the ISDH findings, CMS notified Petitioner by letter dated July 27, 2000, that CMS determined that "the deficiencies limit the capacity of (Petitioner) to render adequate care and ensure the health and safety of (Petitioner's) patients." CMS further advised that the termination of Petitioner's participation in Medicare, Medicaid and other Federal health care programs was effective July 14, 2000, as Petitioner was previously notified. (2) Petitioner filed a timely request for hearing. The case was assigned to Administrative Law Judge Montano for hearing and decision and then reassigned to me on October 18, 2001. On March 12, 2001, Petitioner filed its motion for summary judgment with supporting brief and materials (P. Br.). On May 25, 2001, CMS filed its motion for summary judgment and opposition to Petitioner's motion, with supporting brief and materials (CMS Br.). Petitioner filed a brief in opposition to the CMS motion and in reply to the CMS opposition to Petitioner's motion on June 25, 2001 (At Oat). CMS moved for leave to file a reply to the Petitioner's opposition to the CMS motion for summary judgment on July 24, 2001 (CMS Reply). The CMS motion for leave to file is granted and the reply brief and supporting materials are accepted as filed on July 24, 2001. Both parties submitted exhibits in support of their respective motions. None of the exhibits offered by either party were marked in accordance with the Civil Remedies Division Procedures, copies of which were provided to both parties when the case was docketed. I am not rejecting the pleadings as nonconforming due to the age of the case. I am accepting Petitioner's markings and admit for purposes of this motion, Petitioner's exhibits (P. Ex.) A through Z, AA, Reply Brief Exhibits (RB) 1 through RB 3, and the unmarked affidavit of Dorian Lauer, executed March 8, 2001, which I have marked At Ex. BB. CMS submitted exhibits in support of its motion, none of which are marked. I have marked the exhibits CMS Ex. 1 through 10 and they are admitted for purposes of this motion. (3) II. Findings
of fact The facts material
to disposition of this case are not disputed for purposes of this motion.
The following findings of fact are taken from the briefs and exhibits
submitted by the parties. 1. Petitioner was
certified to participate in Medicare, Medicaid and other federal health
care programs as a home health agency on January 17, 1991. 2. On June 29, 2000,
the ISDH conducted a complaint survey and a follow-up or revisit survey
of Petitioner. 3. The ISDH found
a deficiency under 42 C.F.R. � 484.18(b) (Tag G 164) related to Patient
6, also referred to as Harold R., as a result of the complaint survey
on June 29, 2000. P. Ex. C; CMS Ex. 1 (Ex. B). 4. The ISDH found a deficiency under 42 C.F.R. � 484.18 (Tag G 157) related to Patient 5, also referred to as Ilene F., as a result of the revisit survey on June 29, 2000. P. Ex. D; CMS Ex. 1 (Ex. H) 5. Petitioner was
also the subject of surveys in February and April 2000, but the only alleged
condition level deficiencies remaining on the final survey of June 29,
2000, were the two alleged violations of 42 C.F.R. � 484.18 (Tags G 157
and 164) related to Patients 5 and 6 and they are the basis for the termination
of Petitioner. CMS Ex. 7, at 2. (4) 6. The following findings of fact relate to Patient 5, Ilene F.:
P. Ex. M; CMS Ex. 2. 7. The following findings of fact relate to Patient 6, Harold R.:
8. By letter dated
June 1, 2000, CMS notified Petitioner that it no longer met the conditions
for participation under the Medicare program based upon surveys dated
February 17 and April 14, 2000, and that its provider agreement would
terminate July 14, 2000 unless Petitioner showed it was in compliance.
CMS Ex. 7 (Ex. A). 9. By letter dated
July 27, 2000, CMS advised Petitioner that the revisit and complaint survey
of June 29, 2000, found that Petitioner continued out of compliance with
42 C.F.R. � 484.18 and that the termination of Petitioner's provider agreement
effective July 14, 2000, remained in effect. CMS Ex. 7 (Ex. B). III. Conclusions
of law 1. Summary judgment
is appropriate because the material facts are not in dispute and this
case can be decided as a matter of law. 2. CMS has not made
a prima facie showing that there were repeated standard-level deficiencies. 3. CMS has not made
a prima facie showing that termination is warranted by repeated standard-level
deficiencies. 4. The deficiencies
cited by CMS are not condition-level deficiencies, individually or collectively,
but, rather, to the extent they are deficiencies, they are isolated and
not recurring, and termination is not warranted. 5. CMS failed to
make a prima facie showing that a deficiency existed with respect to Patient
6, Harold R. 6. CMS made a prima
facie showing of a deficiency with respect to Patient 5, Ilene F., but
Petitioner has shown by a preponderance of the evidence that the deficiency
was not at a condition-level. 7. Termination is
not reasonable. IV. Analysis
The Social Security
Act (Act) sets forth requirements for home health agencies participating
in the Medicare and Medicaid programs, and authorizes the Secretary of
Health and Human Services to promulgate regulations implementing the statutory
provisions. Act, �� 1861(o) and 1891 (42 U.S.C. �� 1395x(o); 1395bbb).
The Secretary's regulations governing home health agency participation
in the Medicare program are found at 42 C.F.R. Part 484. In order to participate
in the Medicare program and obtain reimbursement, 42 C.F.R. � 488.3(a)(2)
requires that a home health agency must be in compliance with all applicable
"conditions" as specified in 42 C.F.R. Part 484. Periodic review of compliance
with the conditions of participation is required and such reviews or surveys
are generally conducted by the State survey agency. Based upon its survey,
the State survey agency either certifies compliance or noncompliance of
the surveyed provider. 42 C.F.R. � 488.20. The State survey
agency certifies that a home health agency is not in compliance with the
conditions for participation when "the deficiencies 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). Whether or not there is compliance with a condition
of participation depends upon the "manner and degree to which the provider
. . . satisfies the various standards within each condition." 42 C.F.R.
� 488.26(b); CSM Home Health Services, DAB No. 1622, at 6-7 (1997).
The State agency is to assess the provider's performance against the appropriate
standards to determine and document the nature and extent of any deficiency
and to assess the need for correction or improvement. Surveyors are required
to "directly observe the actual provision of care and services to residents,
and the effects of that care, to assess whether the care provided meets
the needs of individual residents. . . ." 42 C.F.R. � 488.26(c). Furthermore,
deficiencies, which considered individually might not constitute violation
of a condition of participation, should also be considered collectively
with all other deficiencies to determine whether a condition of participation
has been violated. CSM Home Health Services at 7. The Departmental
Appeals Board (DAB) has also interpreted 42 C.F.R. � 488.28 to permit
CMS to terminate a provider where there are repeated standard-level violations,
none of which rise to a condition-level violation either singly or collectively,
if the provider does not timely submit a plan of correction acceptable
to CMS and implement the accepted plan. Id. at 19.
A provider terminated
for noncompliance by CMS has a right to have the determination reviewed
in accordance with the procedures of 42 C.F.R. Part 498. The administrative
law judge reviewing the termination may review the characterization of
deficiencies as condition or standard level violations. The administrative
law judge may also determine whether termination was appropriate given
the deficiencies found on review. CSM Home Health Services at
6-7. CMS bears the burden
of producing evidence sufficient to establish a prima facie case. CMS
must set forth the basis for its determination with sufficient specificity
for a petitioner to respond and come forward with evidence related to
the disputed findings. The evidence set forth by CMS must be sufficient
to establish a prima facie case that CMS had a legally sufficient basis
to impose a remedy. In order for a petitioner to prevail, the petitioner
must then prove by a preponderance of the evidence on the record as a
whole that it was in substantial compliance with the relevant statutory
and regulatory provisions. Hillman Rehabilitation Center, DAB
No. 1611, aff'd Hillman Rehabilitation Center v. U.S. Dept.
of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). Summary judgment is appropriate and no hearing is required where either: there are no disputed issues of material fact and the only questions that must be decided involve application of law to the undisputed facts; or, the moving party must prevail as a matter of law even if all disputed facts are resolved in favor of the party against whom the motion is made. A party opposing summary judgment must allege facts which, if true, would refute the facts relied upon by the moving party. See e.g., Fed. R. Civ. P. 56(c); Garden City Medical Clinic, DAB No. 1763 (2001), Everett Rehabilitation and Medical Center, DAB No. 1628, at 3 (1977) (in-person hearing required where non-movant shows there are material facts in dispute that require testimony); see also, New Millennium CMHC, DAB CR672 (2000); New Life Plus Center, DAB CR700 (2000). On summary judgment, if CMS cannot establish its prima facie case, then Petitioner prevails as a matter of law.
The regulations
in 42 C.F.R. Part 484 establish the conditions and standards by which
home health agency compliance with the Medicare program is determined.
The standards set forth in the regulations are essentially the yard sticks
by which surveyors measure the level of compliance of the home health
agency. If home health agency performance does not measure-up to the regulatory
standard, a deficiency exists. If a deficiency is found the question is
whether that deficiency alone or considered in combination with another
deficiency is "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). If the provider's
capacity to furnish adequate care is substantially limited or, if the
health and safety of patients is adversely affected, then a condition-level
deficiency exists and termination must occur. If no condition-level deficiency
exists, CMS may still consider whether one or more standard-level deficiencies
are repeated on survey and resurvey and, if no correction has occurred,
CMS may declare the provider agreement terminated on that basis. Summary judgment is appropriate in this case because the facts material to resolution of this case as set forth in my findings of fact are not disputed. The only issues to be resolved are questions related to the application of law to the undisputed facts. The specific issues are: whether the undisputed facts show that there was a basis for termination due to one or more condition-level deficiencies; if no condition-level deficiencies were properly found, whether repeated standard-level deficiencies existed for which there was no acceptable plan of correction; and, in the case of the later, whether termination was appropriate. There are also two legal issues for analysis underlying each of the first two specific issues, i.e., whether CMS made a prima facie showing that there was one or more deficiencies and their level and, if so, whether Petitioner established compliance or an affirmative defense by a preponderance of the evidence.
CMS does not allege and has not shown that termination in this case is based upon a finding that the alleged deficiencies were repeated standard-level deficiencies for which no acceptable plan of correction existed. CMS has offered evidence only as to the results of the survey of Petitioner completed on June 29, 2000, and no earlier surveys. CMS clearly takes the position that the deficiencies cited in the June 29, 2000 survey report, individual or collectively, amounted to a condition-level deficiency that warranted termination of Petitioner's provider agreement. See CMS Brief, at 21-24; CMS Reply.
The CMS notice letter of June 1, 2000, indicates that the February 17, 2000 complaint survey found the complaint substantiated, but it is not alleged that the deficiency found violated a condition of participation. (7) The letter does indicate that the April 14, 2000, revisit and complaint survey found that the condition of participation established by 42 C.F.R. � 484.18 was violated. Although the report of survey for April 14 has not been offered by CMS, the report of survey dated June 29, 2000 indicates that it was a revisit on a complaint related to Patient 5, Ilene F. CMS Ex. 7, (Ex. D, at 1); CMS Ex. 3 (Ex. H); P. Ex. D, at 1. CMS specified in the notice of June 1, that Petitioner's participation was being terminated effective July 14. Although it is not clearly so, it seems CMS also provided Petitioner the opportunity to cure the noncompliance with the language:
CMS Ex. 7 (Ex. A)
(emphasis added). Petitioner disputed
the findings of the April 2000 survey and the propriety of the termination
of its provider agreement. Petitioner cited factual and procedural errors
and that a plan of correction was submitted with no action by CMS. Petitioner
requested a resurvey. P. Ex. E, at 1. The June 29, 2000 survey found continuing noncompliance with 42 C.F.R. � 484.18 in the case of Patient 5. The June 29, 2000 survey also found a condition level violation of that same regulation in the case of the fresh compliant related to Patient 6. (8)
CMS alleges that
Petitioner violated the condition of participation set out at 42 C.F.R.
� 484.14 by accepting Patient 5, Ilene F., as a patient when Petitioner
knew that it could not provide all the home health aide hours ordered
by Patient 5's doctor. Section 484.14 establishes the condition that "(p)atients
are accepted for treatment on the basis of a reasonable expectation that
the patient's medical, nursing and social needs can be met adequately
by the agency in the patient's place of residence." Petitioner does not
dispute that it did not provide all the home health aide hours ordered
during the period April 11, 2000 through June 10, 2000. Petitioner also
does not argue that it "adequately met" Patient 5's needs despite the
fact that it did not provide all the home health aide hours ordered by
Patient 5's doctor in her plan of care. Thus, CMS has made a prima facie
showing of a deficiency. The second issue
is whether the deficiency amounted to a condition-level deficiency. The
test for determining whether a deficiency is at the condition level is
whether or not the provider's capacity to furnish adequate care is substantially
limited or, if the health and safety of patients is adversely affected.
42 C.F.R. � 488.24(b). After its opening brief, CMS prudently dropped
the argument that the deficiency related to Patient 5 substantially limits
Petitioner's capacity to furnish adequate care. Petitioner's failure to
provide all ordered home health aide hours for Patient 5 does not appear
to have any impact whatever upon Petitioner's overall ability to provide
home health aide services. CMS never explained in its opening brief how
the failure to deliver all the hours of services ordered either limited
Petitioner's ability to provide adequate care or made the care actually
delivered inadequate. CMS Brief, at 21.
The strongest argument that CMS advances is that the failure to provide home health aide services in this case may have an adverse affect upon Patient 5's health and safety. In this case, I conclude that some of the ordered home health aide tasks had some medical impact, and to the extent the tasks were not done, there was the potential for adverse impact to Patient 5's health and safety. (9) Hence, I also conclude that CMS has made a prima facie showing that the deficiency is a condition-level deficiency. I agree with CMS that actual harm is not required for a condition-level deficiency to exist. I agree with Judge Kessel that a fair reading of 42 C.F.R. � 488.24, is that a deficiency that adversely affects the safety of a patient includes a situation where the deficiency only has the potential for harm. National Hospital for Kids in Crisis, DAB CR413 (1996). In light of my conclusions,
it is necessary to analyze whether Petitioner has shown, by a preponderance
of the undisputed evidence, that either no deficiency existed or that
the deficiency did not potentially adversely impact Patient 5's health
or safety. Petitioner has never
disputed that it did not provide all the ordered hours. However, Petitioner
argues that there is no deficiency because Patient 5, her family, and
her doctor all knew that Petitioner could not provide all the home health
aide hours ordered, but all nevertheless wanted Petitioner to provide
what service it could. It is important to note that neither the Act nor
the regulations provide that a Patient may waive a condition of participation.
Therefore, the fact that everyone but CMS may agree that Petitioner should
provide all the service it could is no defense if the services provided
do not meet the doctor's order as indicated in the plan of care.
Petitioner advances the alternative argument that it properly documented the missed hours in all but three cases. CMS argues that the documentation was sporadic and untimely and there is no indication that the treating doctor modified his order for home health aide services. CMS Ex. 2 is an extract of CMS interpretive guidelines provided to State survey agencies for the conduct of surveys. While this policy document is not binding as law, such documents are followed by State survey teams and are often used by providers to help them maintain compliance. Thus, it is appropriate to hold CMS to the language of this document. Tag number G157 is in issue here. The section 484.18 guideline provides in part:
CMS Ex. 2. This CMS policy clearly indicates that failure to provide all services required under a plan of care is not a per se violation of the conditions for participation for which the provider is strictly liable. The policy provides that failure to provide all the visits ordered alters the plan of care and the doctor must be notified. The policy does not establish any sort of time-limit or deadline for notifying the doctor. The policy also does not specify the form of the notice. CMS has offered no policy or other document which might have given Petitioner notice of any time-limit or format requirement. CMS has offered a plethora of declarants stating the opinion that Patient 5's doctor was not timely noticed of missed visits, but none reveal the source of any time-limit, content, or form requirement. (10) The policy does specify that notice to the doctor may be evidenced in two different manners: by "a physician's order to cover the missed visit" or by documentation in the clinical record indicating that the doctor was aware of the missed visit. The policy does not clarify what is meant by "order to cover the missed visit." The order contemplated in the policy might be an order to make-up the missed visit, an order excusing the missed visit, or some other order. The policy also does not specify whether a phone call to the doctor's office with a memorandum for the clinical record, a chart note, a copy of an email or some other document is required as evidence the doctor was notified of the missed visit. The policy does not prohibit notice of multiple missed visits in one call, email, letter or other notice. The policy also does not prohibit advance notice that visits will be missed although the policy is written in the past tense, indicating notice is not required until a visit is actually missed. Contrary to the
position that CMS takes in its pleadings, there is also no requirement
that the doctor actually indicate that he concurred with the missed visit
or alter the plan of care. The plan of care states the doctor's goals
for the patient and the means the doctor deems appropriate to achieve
the goal. In this case, the doctor believed that a certain number of home
health aide hours were necessary to meet the goal that the "(c)lient is
to receive safe, effective personal care." See CMS Ex. 3 (Ex.
I, at 2 and 4); P. Ex. G (HHA 25 hours per week to assist with personal
care and ADLs (activities of daily living)). The fact that Petitioner
could not meet all the hours of home health aide services ordered does
not require the doctor to modify the plan of care. Rather, as the policy
states, Petitioner's failure to deliver the hours ordered constituted
an alteration or deviation of which the doctor had to be notified. The
undisputed evidence is that in the case of Patient 5, Petitioner has produced
documentation that the doctor was notified of missed hours in all but
three instances. Thus, except in the three cases where it has produced
no documentation of notice of missed visits, Petitioner has satisfied
CMS policy requirements and no deficiency exists. Petitioner also
takes the approach that Patient 5 was accepted as a patient at the insistence
of the patient after Petitioner made clear that it could not provide all
the home health aide hours. The preponderance of the evidence is that
Patient 5 and her daughter were on notice that Petitioner was taking the
case with insufficient staff. (11) With
this knowledge and the understanding that Patient 5's daughter would provide
some care, (12) the doctor and daughter
consented to the arrangement with Petitioner. P. Ex. A, at 2 - 3; P. Ex.
I; P. Ex. P. In fact, Patient 5 had a home health aide, Maxine Baumgartner,
since 1997. But Patient 5 and her daughter were dissatisfied with the
provider that employed Ms. Baumgartner for a number of reasons including
that additional hours of home health aide were promised but not delivered.
Ms. Baumgartner initiated the contact with Petitioner. Although Petitioner
advised Ms. Baumgartner that it would have difficulty providing all the
hours Patient 5 wanted, Patient 5 and her daughter nevertheless chose
to change to Petitioner, and Ms. Baumgartner became an employee of Petitioner.
Eventually, Petitioner retained an additional aide to help Patient 5,
but then Patient 5's State funding was cut and the additional coverage
was no longer authorized. (13) P. Ex.
I and P. Petitioner's point is persuasive. Because Patient 5 lived with
her daughter who had been providing care for an extended period and because
all involved were aware that Petitioner could not provide all the hours
of home health aide ordered by the doctor, the failure to provide all
the hours had no adverse impact and no potential for adverse impact upon
Patient 5's health and safety. P. Brief, at 6. CMS never addresses this
argument directly. CMS counsel in their briefs and the CMS declarants
all conclude that there was a potential for harm to Patient 5. However,
other than the assertion that the home health aide was to perform some
health related duties, there is no explanation of the basis for that conclusion.
(14) While I find the CMS witnesses credible and I am willing
to accept them as experts in their fields, I am not bound to accept their
unexplained and unsupported opinions, particularly on the ultimate issue.
I conclude that,
while there is an admitted deficiency, (15)
Petitioner has demonstrated by a preponderance of the evidence that there
was no actual harm and no potential for harm to the health or safety of
Patient 5. All who were responsible for caring for Ilene F., including
her doctor, daughter and home health aide, were fully aware of Petitioner's
inability to provide all the home health aide hours ordered and they could
adjust their care accordingly to protect the patient. Given the knowledge
of those involved in caring for Ilene F., I find no indication of a potential
for harm to her due to Petitioner's inability to provide all the home
health aide hours ordered. (16) CMS must do more to survive a motion for summary judgment than present the conclusory opinions of its experts that a deficiency existed. To survive a motion for summary judgment, CMS cannot simply rely upon its prima facie showing, but must specifically address Petitioner's arguments and evidence presented. Having construed the facts in a light most favorable to CMS, I see no combination of facts from the pleadings and materials before me that would permit CMS to prevail on these issues in a hearing on the merits.
It is well settled that CMS has the initial burden of making a prima facie case. Black's Law Dictionary (7th Ed.) provides several definitions of "prima facie case." The most useful is:
The DAB defined
the requirements for a prima facie case in its decision in Hillman,
at 8: HCFA (CMS) did
not dispute that it has the burden of coming forward with evidence establishing
a prima facie case that Hillman substantially failed to comply with program
requirements. This is appropriate because HCFA's determination to terminate
a provider agreement must be legally sufficient under the statute and
regulations. We agree with the ALJ that HCFA must identify the legal criteria
to which it seeks to hold a provider. Moreover, to the extent that a provider
challenges HCFA's findings, HCFA must come forward with evidence of the
basis for its determination, including the factual findings on which HCFA
is relying and, if HCFA has determined that a condition of participation
was not met, HCFA's evaluation that the deficiencies found meet the regulatory
standard for a condition-level deficiency. If a provider appeals
a termination decision, CMS has the initial burden of showing that its
decision to terminate is legally sufficient under the statute and regulations.
To make a prima facie case that its decision was legally sufficient, CMS
must: (1) identify the statute, regulation or other legal criteria to
which it seeks to hold the provider; (2) come forward with evidence upon
which it relies for its factual conclusions; and (3) show how the deficiencies
it found meet the regulatory standard for a condition-level deficiency,
if the allegation is that a condition of participation was not met. In the case of Patient 6, Harold R., CMS alleges that the applicable legal criteria are at 42 C.F.R. � 484.18(b) which establishes the requirement for periodic review of a patient's plan of care. The standard established by 42 C.F.R. � 484.18(b) requires, inter alia, that:
CMS alleges that
the evidence it offers shows that Patient 6 had a change of condition
in December 1999 and that Petitioner failed to give Patient 6's physician
notice of that change. CMS alleges that the failure to give the physician
notice of Patient 6's changes in December 1999, was a deficiency that
resulted in actual harm to Patient 6 in April 2000, which causes the deficiency
to be a condition-level deficiency. (17) I conclude that
CMS has failed to establish the second element of its prima facie case,
i.e., that there were changes in Patient 6's condition that suggested
a need to alter the plan of care for Patient 6. Because there were no
changes which required notice, there was no deficiency that could be characterized
as condition-level. The evidence upon which I rely is truly undisputed and was presented by CMS. My rational for finding no change is based upon the evidence presented by CMS. My rational is supported by the unrebutted affidavit of Patient 6's treating physician. CMS argues that the evidence of a change in condition is at CMS Ex. 3 (Ex. F), the Supervisory Visit nurse notes dated December 6, 1999, which indicates that Patient 6 had a black-eye, that he had a urine odor indicating bladder incontinence and that he was unsafe in his home. (18) In order to determine whether there has been a change in a patient's condition, it is necessary to do a longitudinal review of the available clinical records. In this case, the surveyors captured copies and CMS has offered as evidence, doctor's orders from October 15, 1999 through April 7, 2000; the intake nursing assessment from Patient 6's admission on October 1, 1999; a nutritional assessment; Plans of Care from October 1, 1999 through March 21, 2000; and Supervisory Visit reports from October 20, 1999 through March 31, 2000. I set forth in detail in my findings of fact 7.c. through 7.t. the facts I gleaned from my review of the clinical record. The nursing assessment
dated October 1, 1999, showed that Patient 6 suffered from neuropathy
with difficulty ambulating and dementia; he was oriented but had slurred
speech due to a speech impediment; he was confused regarding date and
time; he had a healed area on his right elbow; he has a history of broken
leg with plating; he used a cane and wheelchair; he has feeling in his
lower extremities, but no strength; he was limited to partial weight bearing
with a cane for support; he had gross involuntary movement of his upper
extremities; he needed assistance with dressing and grooming; and he was
not on medication. CMS Ex. 3 (Ex. D). The plan of care dated October 1,
1999, approved by Dr. Acker on October 15, 1999, ordered 2 hours of home
health aide services 2 times per week or a total of 18 hours per month
for assistance with personal care and homemaker services of like hours
for light housekeeping. Both the prognosis and rehabilitation potential
are noted to be poor and the goal is to maintain the patient in the home
with personal care and activities of daily living met through home health
aide visits. CMS Ex. 3 (Ex. E, at 1-2). The supervisory nurse note from
November 12, 1999, indicates that his apartment was cluttered. The plan
of care dated December 1, 1999 and approved by Dr. Acker on December 14,
1999, is essentially the same as that from October, except the summary
states "(c)lient refuses homemaker services and refuses to allow aide
to provide much care." CMS Ex. 3 (Ex. E, at 3-4). This evidence indicates to me that on intake, it was apparent that Patient 6 had a problem with falling and/or injuring himself as he had an old abrasion on his arm and he had a history of a broken leg. Further, on intake it was known that he suffered dementia and was confused; that he had difficulty controlling his upper extremities; and that he was so weak in his lower extremities that he could not stand unassisted and he relied mostly on a wheelchair or rolling chair to get around. Patient 6's confusion, inability to control his upper extremities; lower extremity weakness; and use of a cane/wheel chair/rolling chair for ambulation all posed an increased risk for falls. It is clearly noted on intake that the patient required assistance with grooming and dressing, and while reports in October and November do not indicate he was not cooperative, the report from November 12, 1999 indicates his apartment was cluttered and the report from December 1, 1999 indicates he was refusing personal assistance. CMS presents the declarations of Anita Doctor, Team Leader of the June 2000 survey (CMS Ex. 4), and Brenda Roush, team member for the June 2000 survey (CMS Ex. 3). Both opine that:
CMS Ex. 3, at 4-5; see also CMS Ex. 4, at 5. They assert that failure to report was a condition-level deficiency. However, if we compare the status of Patient 6 as revealed in the clinical records prior to December 1999, with his status as reflected in the December 1999 reports, we find that he was demented and confused, had difficulty with ambulation and had a history of falls and self-injury prior to December 1999. It is not clear where Ms. Doctor and Ms. Roush obtained the information that Patient 6 had trouble changing positions independently, but such would be consistent with his reported trouble controlling his arms. (19) CMS fails to make a prima facie case because CMS has not shown that there was a change of condition that required notice that was not given. The only difference in status between October 1999 and December 1999, is that in December it was noted that Patient 6 smelled of urine and was possibly incontinent. CMS further fails because the unrebutted declaration of Patient 6's treating doctor is to the effect that he was aware of Patient 6's condition and there were no changes in medical status that would have provoked him to change the plan of care. I also note that, while I accept that actual harm is not required, I see no nexus between the injury which Patient 6 suffered in April 2000 and his condition in December 1999. (20) Even if I concluded that CMS made a prima facie showing, I would conclude that Petitioner prevailed by a preponderance of the evidence based upon the unrebutted declarations of Patient 6's doctor. The declarations are credible given the doctor's training, his long relationship with Patient 6, and the absence of evidence to the contrary. Though I draw inferences in favor of CMS based upon a view of the evidence most favorable to CMS, CMS cannot prevail on summary judgment where, as here, it fails to address the evidence and arguments of Petitioner. CMS cannot prevail based upon the conclusory opinions of its survey team members, no matter how qualified they are, where the basis for their opinions are not clearly articulated. (21) V. Conclusion For the foregoing reasons, I conclude that as a matter of law there was no condition-level deficiency shown by the June 29, 2000 revisit and complaint survey. Thus, Petitioner was in substantial compliance on that date and termination of Petitioner's participation agreement was unsupported and improper. The CMS declaration of noncompliance and termination of Petitioner's participation agreement is therefore void. |
|||||||||||||||||||||
JUDGE | |||||||||||||||||||||
Keith W. Sickendick Administrative Law Judge |
|||||||||||||||||||||
FOOTNOTES | |||||||||||||||||||||
1. Effective July 5, 2001, the Health Care Financing Administration (HCFA) was renamed the Centers for Medicare & Medicaid Services (CMS). 66 Fed. Reg. 35,437 (2001). 2. Complaint and revisit surveys were done in February and April 2000, which led to the CMS notice of June 1, 2000, advising Petitioner that it was not in substantial compliance with the condition of participation established by 42 C.F.R. � 484.18, and that it would be terminated June 14, 2000 if it did not show that it was in substantial compliance. CMS Ex. 7 (Ex. A). 3. Following is the list of CMS exhibits as I have marked them: CMS Ex. 1 - Order Appointing Emergency Temporary Guardian, Allen Superior Court, dated 4/17/2000. CMS Ex. 2 - Interpretive Guidelines - Home Health Agencies (Rev. 260)(Extract), at B37-B40. CMS Ex. 3 - Declaration of Brenda Roush, May 24, 2001 (with Exs. A through N thereto). CMS Ex. 4 - Declaration of Anita Doctor, May 23, 2001 (with Exs. A through N thereto). CMS Ex. 5 - Declaration of Iris Stone, May 23, 2001 (with Exs. A through C thereto). CMS Ex. 6 - Declaration of Deb Sorg, May 24, 2001 (with Ex. A thereto). CMS Ex. 7 - Declaration of Douglas Wolfe, May 24, 2001 (with Exs. A through D thereto). CMS Ex. 8 - Declaration of Lorraine Rice, July 24, 2001 (with Exs. A and B thereto). CMS Ex. 9 - Second Declaration of Brenda Roush, July 18, 2001. CMS Ex. 10 - Declaration of Thomas Reed, July 18, 2001 (with Exs. A and B thereto). In this decision, references to exhibits attached to exhibits will be parenthetically noted, e.g., CMS Ex. 10 (Ex. A, at 1). 4. Counsel for CMS alludes to deficiencies cited on earlier surveys, but does not allege that they were uncorrected at the time of the June 29 revisit and complaint survey. CMS Brief, at 4. Furthermore, the CMS termination notice of July 27, 2000 cites only a condition level violation of 42 C.F.R. � 484.18. CMS Ex. 7 (Ex. B). 5. Respondent CMS does not dispute Petitioner's assertion that the State surveyors only captured recorded home health aide hours charged to Medicaid and failed to include home health aide hours charged to another state program. Thus, I accept Petitioner's reported hours at P. Ex. RB 2 (Ex. A, at 2) as being factually accurate. Respondent accurately notes that even Petitioner's numbers show that less than all ordered home health aide hours were provided during the period April 11, 2000 through June 10, 2000. A fact which also increases the credibility of Petitioner's numbers. CMS Reply, at 5. 6. The Bureau of Aging and In-Home Services is a component of the Indiana Family and Social Services Administration. IND STAT ANN 12-10-1-1. 7. CMS presented no evidence as to the nature of the complaint or what deficiency was found. 8. I find this case raises several interesting questions that neither party addressed. The evidence does not reveal when the complaints related to Patients 5 (Ilene F.) and 6 (Harold R.) were actually made. The evidence also does not reveal why the complaint related to Ilene F. was investigated before the complaint related to Harold R., though the events related to Harold R. all occurred before Ilene F. even became a patient of Petitioner. The survey completed on April 14, 2000, cited Petitioner for a condition-level violation of 42 C.F.R. � 484.18 related to Ilene F. only three days after she became a patient of Petitioner. It is not clear that the facts related to the alleged violation in April 2000 are the same as the facts that support the deficiency cited in June 2000. Certainly few, if any, of the facts cited in the June-report related to Ilene F. could have been known on April 14, 2000. However, resolution of these questions is not necessary given my disposition of the case. 9. CMS Ex. 3 (Ex. J) may not actually require checking pressure areas as CMS alleges. The block is not marked with an "x" as are other items. Further, the home health aide was not to administer medication as CMS argued; rather, the aide was to remind Patient 5 to take her medication. It is also not clear that the aide was to do much in the way of skin and foot care other than assistance with normal hygiene as there is no evidence of problems with pressure sores or ulcerations. CMS Ex. 3 (Ex. J) may order nothing more than housekeeper, cook and personal assistance duties with no direct medical impact whatever. If that was an accurate reading of the exhibit, then I would conclude that CMS failed to make a prima facie case in that it failed to show that the deficiency had even a possible impact upon Patient 5's health and safety. However, for purposes of summary judgment, I will construe these fact in a light most favorable to CMS and find that some of the ordered duties had some medical significance. 10. I do not question the expertise, honesty, honor, integrity, probity, or veracity of any of Respondent's declarant's. However, it is fundamental that I cannot judge an expert's opinions credible absent a showing of the basis or foundation for the opinion - mere conclusory statements are an insufficient foundation. 11. Clearly, Petitioner was attempting to hire additional staff prior to taking Patient 5. P. Ex. A 12. Patient 5 lived with her daughter. 13. The implication is that the Patient's perceived need for home health assistance is dictated by the availability of funding. Certainly, one possibility in this case is that Patient 5's doctor ordered home health aide hours to the maximum extent that State and Federal funding allowed, even in excess of the patient's actual need, perhaps to give the patient's daughter a break, perhaps to avoid the cost of nursing home care. This interpretation of the facts is consistent with the fact that Patient 5 never received all the home health aide hours ordered from her prior service; that she was willing to go to Petitioner even though Petitioner clearly let her know that it could not provide all the ordered hours; and that the home health aide hours were reduced due to the elimination of funding even though there is no indication of improvement in patient's condition. If this view of the facts is correct, then it would be clear that Petitioner's failure to provide all ordered hours had no impact and no potential for impact upon Patient 5's health and safety because the hours ordered were not ordered based on Patient 5's needs. 14. There never has been an allegation that Patient 5 suffered harm as a result of Petitioner's actions or failure to act. 15. The survey team characterized the deficiency as Petitioner accepting Patient 5 without a reasonable expectation that it could provide all services required. In fact, the allegations of the survey report are that Petitioner accepted Patient 5 and then failed to provide the ordered services. CMS Ex. 3 (Ex. H). The latter approach is most consistent with the State survey agency's mandate to use "resident outcomes" as the primary means for evaluating compliance. 42 C.F.R. � 488.26(c)(2). The former approach is not helpful to CMS. While Petitioner clearly warned Patient 5 and her daughter that it might have difficulty providing all the hours required, the evidence is that Petitioner had an expectation that it could hire additional staff and it made significant efforts to accomplish that. P. Ex. A. The reasonableness of that expectation is shown by the CMS evidence that shows there were significant numbers of home health aides in the State of Indiana (CMS Ex. 10) and the fact that within two months Petitioner actually hired an aide to provide the additional hours of services. Thus, if this line of reasoning was followed, it could be concluded that Petitioner had a reasonable expectation of hiring more staff and meeting all requirements and there would be no deficiency. 16. The inherent policy question is whether it would have been better for Petitioner to refuse to provide any service thereby avoiding any challenge by CMS or whether some competent service is better than none. 17. As previously discussed, it is not necessary to show actual harm, as potential harm to patient's health and safety is sufficient. 18. On summary judgment, I construe this evidence in a light most favorable to CMS. Therefore, I am ignoring the inconsistences which appear on the face of this document, e.g., it is stated Patient 6 is unsafe in his home, but the environment block is marked stable; the block for bladder function is marked stable and the note indicates he is incontinent at times possibly indicating that it is normal for Patient 6 to have some incontinence; a neurologic check was performed and the nurse notes no sign of physical problem, but Patient 6 is limited to using a wheelchair or rolling chair due to neuropathy (a neurologic problem). It also appears from the clinical records presented by CMS that this was the first and only visit of Patient 6 by this particular nurse. 19. Again, I am ignoring the obvious inconsistencies that Patient 6 could eat an orange and reported that he was doing his own bath during the supervisory nurse visit on December 6, 1999, but that he was unable to change positions independently. 20. There are several interesting inconsistencies raised by CMS which are never addressed. For example, given Patient 6's limited ambulation, how did he get to the laundry room, why did he fall, how bad was the cut on his head, why was he admitted to the hospital, why was he admitted to the nursing home. These seem to be basic fact questions the survey team should have considered prior to citing Petitioner. CMS also seems offended by Petitioner's failure to send a nurse to see Patient 6 when it was reported in April that he had cut his head. I note that Petitioner's response as reflected in the evidence does not read as callous as CMS suggests, i.e., there is no order for a skilled nurse visit, rather than we won't get paid. I am also of the opinion that upon finding an injured individual, it is never inappropriate to call 911 if the injury appears serious. 21. The consistency of the opinions of the survey team and CMS staff does nothing to add to the credibility or weight of those opinions in this case. It is clear that each CMS witness has simply reviewed and agreed with the opinions of the survey team members. Because the opinions and conclusions of the survey team members are in error, the opinions of the CMS witnesses who reviewed the initial opinions and conclusions must also be in error. It does not appear that CMS did an independent review of the facts underlying the survey teams' conclusions and opinions, and, as Petitioner complains, there is no evidence that CMS considered Petitioner's input at any time during the survey process. | |||||||||||||||||||||