Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Homestead of Denison, |
DATE: October 25, 2001 |
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Centers for Medicare & Medicaid
Services
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Docket No.C-00-106
Decision No. CR830 |
DECISION | |
DECISION This case came before me pursuant to a request for hearing
filed by Homestead of Denison (Petitioner), on November 16, 1999, in accordance
with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R.
�� 488.408(g) and 498.40. A revised request for hearing was filed on December
2, 1999. Petitioner is a skilled nursing facility (SNF) participating
in the Medicare/Medicaid programs. The Texas Department of Human Services
(TDHS) concluded a survey on September 23, 1999, finding that Petitioner
was not in substantial compliance with federal Medicare requirements for
nursing home participants. As a result, the Centers for Medicare and Medicaid
Services (CMS) imposed the remedy of denial of payment for new admissions
(DPNA) from October 2, 1999 through October 11, 1999. I held a hearing in Fort Worth, Texas, on April 10, 2001.
CMS offered 10 proposed exhibits identified as CMS Exhibits (CMS Exs.)
7, 9, 17-21, 24, 28, and 29. CMS's proposed exhibits were admitted without
objection. Petitioner offered four proposed exhibits. These were admitted
into the record as Petitioner's Exhibits (P. Exs.) 6, 8, 9, and 10, without
objection. Neither party introduced the nursing summaries pertaining to
Resident Number One, that covered the period from January to September
1999. Thus, I obtained these summaries from Petitioner and admitted them
into the record as ALJ Exhibit (ALJ Ex.) 1. Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that from October 2, 1999 through October 11, 1999, Petitioner was in substantial compliance with Medicare participation requirements. I further find that CMS is not authorized to impose the DPNA remedy against Petitioner. I. Applicable Law and RegulationsPetitioner is considered a long-term care facility under
the Act and regulations promulgated by the Secretary of the Department
of Health and Human Services (Secretary). The statutory requirements for
participation by a long-term care facility are found at sections 1819
and 1919 of the Act and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act invest the Secretary
with authority to impose remedies against a long-term care facility for
failure to comply substantially with participation requirements. Pursuant to the Act, the Secretary has delegated to CMS
and the States the authority to impose remedies against a long-term care
facility that is not complying substantially with federal participation
requirements. 42 C.F.R. Part 483 provides that facilities which participate
in Medicare may be surveyed on behalf of CMS by State survey agencies
in order to ascertain whether the facilities are complying with participation
requirements. 42 C.F.R. �� 488.10-488.28. The regulations contain special
survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-488.335.
Under Part 488, a State or CMS may impose remedies against a long-term
care facility where a State survey agency ascertains that the facility
is not complying substantially with participation requirements. 42 C.F.R.
�� 488.406, 488.408 and 488.430. Specifically, 42 C.F.R. � 488.417(b),
42 C.F.R. � 488.414, and �� 1819(h)(2)(D), (E) and 1919(h)(2)(C), (D)
of the Act authorize CMS to deny payment for all new admissions in any
case where the facility is not in substantial compliance by the third
month after the last day of the survey identifying the deficiency, or
when a provider has been found to have furnished substandard care on the
last three consecutive standard surveys. The penalty may start accruing
as early as the date that the facility was first out of compliance until
the date substantial compliance is achieved or the provider agreement
is terminated. The regulations define the term "substantial compliance"
to mean:
42 C.F.R. � 488.301. Remedies by CMS are appropriate only after CMS makes a
prima facie showing that the facility has failed to comply substantially
with participation requirements. To prevail, a long-term care facility
must overcome CMS' showing by a preponderance of the evidence. Hillman
Rehabilitation Center, DAB No. 1611 (1997), aff'd sub
nom, Hillman Rehabilitation Center v. United States, Department
of Health and Human Services, Health Care Financing Administration,
No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999). The Act and regulations make a hearing available before
an administrative law judge (ALJ) to a long-term facility against whom
CMS has determined to impose a remedy. Act, section 1128A(c)(2); 42 C.F.R.
�� 488.408(g) and 498.3(b)(12), (13). The hearing before an ALJ is a de
novo proceeding. Anesthesiologists Affiliated, DAB CR65 (1990),
aff'd, 941 F.2d 678 (8th Cir. 1991). II. Issues 1. Whether the facility was complying substantially with
federal participation requirements on the dates CMS determined to impose
a DPNA; and 2. Whether there is a basis for the imposition of remedies
against Petitioner. III. Findings and Discussion The findings of fact and conclusions of law noted below
in italics are followed by a discussion of each finding.
The applicable regulation at 42 C.F.R. � 483.25, entitled "Quality of care," provides:
CMS Ex. 20, at 3-5. Based on observations, interviews and record reviews during
the course of a survey conducted on September 22, 1999, a surveyor noted
at 9:50 a.m. that R1 had significant bilateral pedal edema. The Assistant
Director of Nursing (ADON) stated that this was not a new condition. A
review of the resident's clinical record revealed swelling and inflammation
of her right leg on May 7, 1999, that her physician attributed to arthritis.
On May 10, 1999, according to the surveyor, a nurse noted that R1 had
2+ edema, and was given Tylenol to relieve it. It was pointed out by the
surveyor that Tylenol was not the appropriate remedy since it lacked anti-inflammatory
properties. The clinical record also indicated that the treating physician
was not notified. From May 10, 1999 until June 17, 1999, when R1 was visited
by her physician, no notes were made regarding R1's lower extremities.
At that time, the resident was prescribed Maxzide, which was to be given
daily and then every other day once the edema subsided. For the month of September 1999, no assessment was found
by the surveyor regarding the resident's increased lower extremity edema,
and there was no evidence that the physician had been notified of the
significant edema observed on September 22, 1999. The surveyor concluded that the ADON's assessment, that
the edema was not a new problem and the facility's failure to assess R1's
condition and notify the physician of changes in her condition, placed
R1 at risk for discomfort and/or clinical complications.
Discussion Mr. John Allen, the State surveyor, testified that on
September 22 and 23, 1999, he conducted a follow-up survey of Petitioner's
facility. Allegedly, he found Petitioner to be out of compliance with
the requirement to provide R1 the necessary care and services to attain
or maintain the highest practicable physical, mental, and psychosocial
well-being. This conclusion was premised on the ADON's statement that
"the edema was not a new problem" and the facility's failure to assess
R1's condition and notify the physician of changes in her condition. CMS
Ex. 20, at 4, 5. On direct examination, Mr. Allen reiterated what he had
previously reported in the Statement of Deficiencies (Form 2567). See
Transcript (Tr.) at 36-47. However, he admitted making several erroneous
findings. Initially, he recognized the inaccuracy of his claim that Tylenol
was improperly administered as an anti-inflammatory agent for pedal edema.
CMS Ex. 20, at 4; Tr. at 44, 66. He attempted to explain his misstatement
by saying that he meant to indicate that Tylenol was Petitioner's only
intervention for the edema. Mr. Allen had also concluded that, from May
10, 1999 until R1 was visited by her treating physician on June 17, 1999,
no notes were made regarding her lower extremities. This, he admitted,
was another mistake on his part, inasmuch as there were several assessments
recorded in the record between May 10 and June 17, 1999. Tr. at 71. Mr.
Allen noted in the Form 2567 that one of the reasons for finding Petitioner
non-compliant, with respect to the care given to R1, was the ADON's statement
that lower extremity edema was not a new issue with that resident. CMS
Ex. 20, at 4. He acknowledged, however, that R1 had been treated with
Maxzide for water retention since 1997. Tr. at 69. In that context, the
ADON's statement that the resident's lower extremity edema was not a new
condition could in no way constitute a basis for a deficiency finding. The surveyor determined that the significant edema he
observed on September 22, 1999, was a change in the resident's condition
that should have been reported to her physician. The surveyor concluded
that the facility's failure to do so put the resident at risk for discomfort
and/or clinical complications. Tr. at 62; CMS Ex. 28 at 48. Mr. Allen noted there are several conditions associated
with lower extremity edema. The most significant of these, he said, is
congestive heart failure. Tr. at 4. In his opinion, if the edema had been
left without assessment or intervention, it could have advanced to congestive
heart failure. Tr. at 62. However, he admitted that if R1 had been experiencing
an acute onset of lower extremity inflammation, there might not have been
a need to notify the physician immediately. According to Mr. Allen, it
might have been sufficient to elevate her legs. Tr. at 60, 61. This testimony
was consistent with that of Ms. Sherry Caylor, Petitioner's regional nurse
consultant. She stated that most dependent edema will go away with just
nursing measures alone of elevating the feet. Tr. at 169. Ms. Caylor testified
that, in the case of R1, Petitioner's staff had been monitoring her for
edema for a long time. Ms. Caylor further stated that with position changes,
dietary precautions, and Maxzide, R1's condition was kept under control.
In Ms. Caylor's opinion, R1's edema was not a condition that would be
cured but, rather, could be kept under control with proper daily management.
Tr. at 169, 170. In this regard, Ms. Caylor referred to the facility's
medication sheet for R1 that reflected adequate control of R1's lower
extremity swelling. P. Ex. 9. At 8:00 a.m. on September 22, 1999, the
resident had no edema (P. Ex. 9, at 4), but developed swelling developed
by mid-morning. According to Ms. Caylor, R1's swelling could be attributed
to her sitting position. Ms. Caylor testified that swelling could have
developed within an hour after sitting. Tr. at 207. Pertinent to that
is the reference in the monthly summaries that the resident may have been
sitting too much. ALJ Ex. 1, at 28, 34; P. Ex. 6, at 14. Consistent with
the resident's practice of spending much time in her chair, the facility
placed her near the nurse's station where she could be observed. Ms. Caylor
added that, at some point, one of the staff would notice the resident's
lower extremities and get her feet up. Tr. at 207. I conclude that the
facility had been managing R1's edema for a long time and was aware of
the condition's ups and downs. What occurred on September 22, 1999, did
not call for immediate notification of her physician, nor was it a significant
change in her condition. Ms. Caylor added that it is incorrect to say that pedal
edema could lead to congestive heart failure. She stated that edema of
the lower extremities may be a sign and symptom of congestive heart failure,
but not the cause of it. In this particular case, she noted that the resident
had no respiratory distress and her vital signs were normal. Tr. at 208.
I find the opinion of Ms. Caylor regarding the relationship between pedal
edema and congestive heart failure more persuasive than that of Mr. Allen. In view of the foregoing, I find that R1 was being properly
managed for her pedal edema and was not exposed to risk of congestive
heart failure or other discomfort due to the care she received. Neither
the ADON's response that the edema "was not a new condition," nor the
decision not to call R1's physician on September 22, 1999, constituted
a basis for a finding of noncompliance. I find that the alleged deficiency
posed no greater risk to resident health or safety than the potential
for causing minimal harm.
CMS Ex. 20, at 6, 7. A closed record review(1)
revealed that on September 3, 1999, R3 complained of difficult and painful
urination. The treating physician ordered a urinalysis and a culture and
sensitivity test. The specimen was obtained and forwarded to the laboratory
(lab) for testing. The tests were completed on September 5, 1999 at 8:11
a.m., and the results were called in to the resident's physician at 11:35
a.m. The resident expired of apparent heart problems two days later. CMS
Ex. 20, at 6, 7. The surveyor concluded that the failure to follow up on
the ordered lab test placed R3 at risk for complications of untreated
infection.
Discussion The State surveyor, Ms. Sharon White, testified that the
facility sent the specimen to the lab for testing on September 3, 1999,
and there was no indication in the nurses' notes that the test results
were pursued. Tr. at 105. According to Ms. White, that brought about a
delay that allowed an infection to go untreated. Ms. White was of the
opinion that untreated urinary tract infections (UTI)(2)
in elderly women could cause an electrolyte imbalance. This, Ms. White
reasoned, can lead to mental changes and cardiac problems. Because of
R3's history of having an enlarged heart and hypertension, Ms. White testified
her heart would have to work harder. Ms. White concluded that the electrolyte
imbalance, brought about by the UTI, would cause arrhythmia, making the
heart beat "a strange rhythm." According to Ms. White, the heart could
go faster or slower, "or skip a beat or something like that." Tr. at 109. It is true that it is sufficient for CMS to show that
the resident was put at risk of injury. Actual harm need not be established.
However, that risk cannot be speculative or imagined. In the case before
me, CMS has offered no persuasive explanation for the surveyor's prognostic
theory on possible complications from untreated UTI, nor does that theory
find support in the medical literature. Ms. White asserted that a delay in treating R3's UTI put
her at risk of developing an electrolyte imbalance that could cause the
heart to go into "a strange rhythm" or go faster or slower, or "skip a
beat or something like that." Tr. at 103, 104, and 109. That explanation
is certainly not very scientific. Moreover, I find such an opinion to
be conclusory, and contrary to medical literature that is the resulting
distillate of a plural intelligence. The most widely accepted view in the medical community
does not mention mental changes or heart disease as a possible complication
arising from UTI. Although chronic pyelonephritis is recognized as a possible
complication, probably 10% or fewer of asymptomatic bacteriuria patients
develop renal failure attributable to the UTI. Hypertension as a possible
complication is even more rare. Lawrence M. Tierney, et al.,
Current Medical Diagnosis and Treatment, 663 (30th ed. 1991). It is noted in other literature that:
The American Medical Association Encyclopedia of Medicine
(1989). It is significant that the statistics alluded to above
refer to asymptomatic patients. In these, the UTI tends to go unnoticed
and untreated until complications appear. Even in such cases, the complications
are rare. Furthermore, the same literature supports the view that "many
elderly patients tolerate UTI well." Current Medical Diagnosis and
Treatment, at 663. Consequently, the allusion to R3's age as an added
gravamen in this case is misplaced. Tr. at 103. Additionally, Ms. White
testified that the resident had complained of pain and difficulty urinating.
Tr. at 98. From these symptoms, the surveyor leaped to the conclusion
that because R3 had "such severe symptoms on the 3rd, she would
have expected something to have been done on the 4th." Tr.
at 102. Pain and difficulty urinating are common symptoms of UTI. William
B. Abrams, M.D. & Robert Berkow, M.D., The Merck Manual of Geriatrics,
620 (1990).(3) There is no evidence that
R3 experienced additional symptoms, nor has there been a showing as to
the severity of the symptoms she did have. The use of hyperbole is no
substitute for the proper laying of an evidentiary foundation. CMS attached medical literature to its posthearing brief, yet none is persuasive of its theory that UTI may lead to mental changes or cardiac problems. Excerpts submitted by CMS from the Clinical Nursing treatise do indicate that:
June M. Thompson, R.N., M.S., et al., Clinical
Nursing, 51 (1986). CMS has failed to show, through competent testimony or
other evidentiary approach, that the facility unduly exposed R3 to septic
shock because of an untreated UTI. It cannot be
assumed that a four day wait to obtain culture and sensitivity test results
necessarily placed the resident at risk. Ms. Sherry Caylor, Petitioner's nurse consultant, testified that R3 had been in the hospital on ampicillin, a full spectrum antibiotic. Tr. at 219. Shortly after returning to the facility, the resident developed symptoms that appeared to be consistent with UTI. Ms. Caylor reasoned that since the resident was afebrile and not showing any additional symptoms, waiting for the culture results posed no risk. Tr. at 221; see also CMS Ex. 29, at 10. Ms. Sharon White, the State surveyor, testified that the elderly have a normal temperature of 96.8�F. She was of the opinion that R3's temperature of 98.6�F should have been considered suspicious. Tr. at 100, 101; see CMS Ex. 29, at 10. However, it is one thing to say that the resident had a suspiciously elevated temperature, and another that she had severe symptoms requiring urgent attention to prevent serious complications. CMS argues that Petitioner failed to consult with R3's
physician when there was a significant change in her physical condition
or clinical complications. CMS Brief at 20. CMS additionally contends
that R3 was in distress because she had an elevated temperature and other
more severe symptoms. In this regard, CMS points to its Exhibit 29 at
page 10 in support of the assertion that, on September 5, 1999, the resident's
symptoms had intensified. This, CMS argues, should have prompted a call
to her physician. Id. at 21. These assertions by CMS are without
support in the record. On September 3, 1999, the resident was noted to
be experiencing difficult and painful urination. The succeeding entries
in the nurse's notes, up until R3's demise on September 7, 1999, do not
refer to a significant change in symptoms associated with UTI. The nurse's
notes on September 5th indicate that, at 9:00 a.m., R3 complained
of nausea. But CMS advanced no evidence to establish a nexus between that
symptom and UTI. In fact, R3 had experienced similar symptoms days earlier,
which were not associated with UTI. CMS Ex. 29, at 9. Moreover, R3's vital
statistics reported on that date are not indicative of any distress. In
fact, on the following day, the record specifically stated that she was
in no distress. Id. at 10. I fail to detect a significant change
in R3's condition that merited a call to her physician. CMS also argues that the testing protocols outlined in Diagnostic Microbiology reflect that, of the nine tests available for gram negative bacteria, such as the E. coli found in R3's lab results, only one test has a grow-out rate of four to 72 hours. See Betty A. Forbes, Ph.D., et al., Diagnostic Microbiology, 183-184, 425 (10th ed. 1998). The remaining eight tests ranged from four to 18 hours and 18 to 48 hours. It is CMS's position that, even if the test took 72 hours, the facility should have contacted the lab not later than September 6, 1999, for an update on the results of the lab tests. I agree with CMS that, although the nurse's notes show an entry on September 6, 1999, the urine analysis was still pending. However, that is not sufficient evidence for the conclusion that the facility made an inquiry to the lab to determine the status of the test results. CMS Ex. 29, at 10. On the other hand, the facility's decision to wait up to four days before inquiring about the culture and sensitivity test results, in accordance with the lab's protocol, cannot be considered a dereliction of its duty. See P. Ex. 10, at 1. It is true that the facility changed labs in order to track specimens more closely. However, I do not find those new procedures to be evidence of a failure to be in substantial compliance in the case at hand. The alleged deficiency posed no greater risk to health or safety than the potential for causing minimal harm.
CMS has not satisfied the criteria for imposing remedies
at the "less than immediate jeopardy" level. CMS has not established a
prima facie case that, as of October 2, 1999, Petitioner was not complying
substantially with participation requirements at 42 C.F.R. �
483.25. Indeed, there is not only an absence of a prima facie case of
noncompliance, but the preponderance of the evidence demonstrates that
Petitioner was complying substantially with 42 C.F.R. � 483.25. Consequently,
CMS is not authorized to impose a DPNA from October 2, 1999 through October
11, 1999. IV. Conclusion I conclude that CMS incorrectly determined that beginning October 2, 1999 through October 11, 1999, Petitioner was not complying substantially with federal participation requirements in the Medicare program at the "less than immediate jeopardy" level. I find that Petitioner was, in fact, in substantial compliance with the federal requirements of 42 C.F.R. � 483.25. |
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JUDGE | |
José A. Anglada Administrative Law Judge
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FOOTNOTES | |
1. When a resident is no longer in the facility, the resident's record is pulled and filed as a closed record. Inasmuch as direct observation is not possible, reliance is placed basically on the documents in the closed record. Tr. at 94. 2. UTI is a bacterial infection of the urethra, bladder, ureter or kidneys. 3. Found at Attachment 4 to CMS's posthearing brief. 4. Septic shock as a complication from UTI had not been previously argued by CMS. | |