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CASE | DECISION |JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Grace Living Center - Jenks,

Petitioner,

DATE: July 14, 2004
                                          
             - v -

 

Centers for Medicare & Medicaid Services.

 

Docket No.C-01-333
Decision No. CR1197
DECISION
...TO TOP

DECISION

I decide that Petitioner, Grace Living Center - Jenks, was in compliance with the federal participation requirement at issue here. Consequently, the Centers for Medicare & Medicaid Services (CMS, formerly known as the Health Care Financing Administration or HCFA) (1) did not have a basis to impose a civil money penalty (CMP) against Petitioner. CMS sought to impose a CMP of $3,050 per day, for the 43-day period of alleged past noncompliance from June 12, 2000 through July 24, 2000.

I. Background

Petitioner is a nursing facility located in Jenks, Oklahoma. On November 13, 2000, the Oklahoma State Department of Health (State agency) conducted a survey of Petitioner. The State agency identified a situation of past noncompliance which had been corrected at the time of the survey and therefore determined that Petitioner was not in substantial compliance with the federal participation requirements of the Medicare and Medicaid programs. By letter dated December 6, 2000, CMS notified Petitioner that, based on the survey that was conducted on November 13, 2000, by the State agency, it was imposing a CMP of $3,050 per day, for the 43-day period of past noncompliance that existed from June 12, 2000 through July 25, 2000. The total amount of the proposed CMP was $131,150.

By letter dated January 16, 2001, Petitioner filed a hearing request. This case was assigned to Administrative Law Judge (ALJ) Mimi Hwang Leahy and subsequently reassigned to me for hearing and decision. The hearing in this case took place in Oklahoma City, Oklahoma from December 3 - 5, 2002.

At the hearing the parties offered exhibits to be admitted into evidence. Petitioner offered into evidence 33 exhibits, Petitioner Exhibits (P. Exs.) 1 - 33. CMS offered into evidence 51 exhibits, CMS Exhibits (CMS Exs.) 1 - 51. I admit into evidence P. Exs. 1 - 33 and CMS Exs. 1 - 51.

CMS and Petitioner filed post-hearing briefs and reply briefs. One attachment accompanied CMS's post-hearing brief, labeled Attachment A. Petitioner's post-hearing brief was accompanied by four attachments labeled Exhibits A - D. CMS's post-hearing reply brief was accompanied by one attachment, labeled CMS Reply Brief Ex. 1. One unlabeled attachment accompanied Petitioner's post-hearing reply brief. None of the attachments were admitted into evidence.

II. Applicable law

Skilled nursing facilities, such as Petitioner, participate in the Medicare program by entering into provider agreements with the United States Department of Health and Human Services (DHHS). Requirements of participation are imposed by statute and regulation. Social Security Act (Act), section 1819 [42 U.S.C. � 1395i-3]; 42 C.F.R. Parts 483, 488, and 489.

The regulations define "substantial compliance" as follows: "Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301.

The regulations define "immediate jeopardy" as follows: "Immediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. � 488.301.

The regulations specify that a CMP that is imposed against a provider will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The lower range of CMPs, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(1)(ii). The upper range of CMPs, from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a provider's residents, and, in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438(a)(1)(i), (d)(2).

The preponderance of the evidence standard is applied to resolve disputed issues of fact, except as provided by 42 C.F.R. � 498.60(c)(2), which states that in CMP cases, CMS's determination as to the level of noncompliance of a provider must be upheld unless it is clearly erroneous. CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that the provider was not in substantial compliance with the participation requirements at issue. Once CMS has established a prima facie case, the provider has the ultimate burden of persuasion: to prevail, the provider must prove by a preponderance of the evidence that it was in substantial compliance with each participation requirement at issue. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. DHHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).

III. Issue, findings of fact and conclusions of law

A. Issue

The issue is whether Petitioner was complying substantially with federal requirements at the time of the survey conducted on November 13, 2000.

B. Findings of fact and conclusions of law

In this section I first address in detail my findings of fact and conclusions of law relative to the deficiency cited by CMS. However, prior to addressing the issue before me, I take this opportunity to make several points in the hope that clarity will prevent misunderstanding and the possible misapplication of this decision.

The parties have vigorously debated two issues that I mention here for the explicit purpose of pointing out that, given the disposition announced in this decision, they are issues that I need not, and therefore, do not address.

First, although Petitioner and CMS have argued the continuing validity and scope of Hillman Rehabilitation Center, DAB No. 1611 (1997), in the analysis of the facts and law supporting this decision it has been unnecessary for me to depart from Hillman as the standard by which CMS's prima facie case is measured. This case is "fact-bound," and even reading Hillman in the light most favorable to CMS's position leads me to find that although CMS may have established its prima facie case, the totality of all the facts establishes a preponderance of evidence in favor of Petitioner's position. Nothing in this decision should be understood as a criticism of Hillman or as an expression of doubt as to its continuing application to litigation in this forum. Indeed, the Departmental Appeals Board has substantially quieted debate on the subject, and is very much in favor of Hillman's continuing robust vitality. See Batavia Nursing and Convalescent Center, DAB No. 1904 (2004).

Next, the parties have offered me well-articulated but rather divergent views as to the precise meaning and application of the term "immediate jeopardy" in the factual context of this case. The term "immediate jeopardy" is defined at 42 C.F.R. � 488.301, and I need not attempt to refine or explicate that definition here. It should be obvious that a decision not to sustain a single citation involving a single resident renders utterly moot any discussion of the scope and severity of that non-sustained citation. Accordingly, nothing in this decision should be understood as an endorsement of either party's position on the meaning of "immediate jeopardy."

Further, as this decision does not sustain CMS's citation and the imposition of a CMP, I need not and therefore will not address the issue of the CMP's reasonableness.

1. Petitioner was in substantial compliance with 42 C.F.R. � 483.25(l)(2)(i) concerning the initiation of antipsychotic drugs.

On November 13, 2000, surveyors from the State agency completed a complaint survey of Petitioner's facility. As a result of this survey, Petitioner was found to be out of compliance with four participation requirements. However, the appeal before me is limited to the one deficiency cited under 42 C.F.R. � 483.25(l)(2)(i) which states: (2)

Antipsychotic Drugs. Based on a comprehensive assessment of the resident, the facility must ensure that--

(i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record . . .

Petitioner was cited for noncompliance with this regulation at an immediate jeopardy level for a single resident, Resident Number 3 (R3), for a period from June 12, 2000 through July 24, 2000. The survey, as regards R3, consisted of a "closed record review" as R3 had been discharged from the facility to St. John's Hospital more than three months before the survey. (3) R3 received antipsychotic drugs at the facility starting on June 12, 2000 until July 24, 2000, when she was transferred out of the facility to St. John's Hospital for treatment of a wound on her left heel. P. Ex. 15, at 52; CMS Ex. 42. Prior to June 12, 2000, R3 was taking no antipsychotic drugs.

R3 was a 93-year-old female admitted to Petitioner's facility on May 23, 2000, following a stay at the Tulsa Regional Medical Center where she had received treatment for bronchitis and dehydration. P. Ex. 5; CMS Ex. 15. The discharge summary from Tulsa Regional Medical Center listed R3's diagnoses as acute bronchitis, Parkinson's disease, organic brain syndrome, hypertension, and constipation. CMS Ex. 15. Prior to her hospitalization, R3 had resided at another nursing home for about six months. The assessment on admission to Petitioner's facility documented that R3 suffered from acute respiratory infection, Alzheimer's disease, Parkinson's disease, aphasia (difficulty or inability to speak), recent weight loss, was oriented to self only (not to time or place), and suffered from other problems as well. P. Exs. 6, 7; CMS Exs. 14, 15, 42 - 44.

The clinical facts that I have treated as most significant in this case are found in Petitioner's records beginning on the date R3 was admitted to the facility, May 23, 2000. CMS asserts that no comprehensive assessment of R3's condition and needs was performed during that time, and that the treatment of R3 with certain medications after June 12, 2000, was improper. Petitioner maintains that its records demonstrate, in effect, an ongoing process of assessment and consultation with the physicians responsible for directing R3's care. The evidence presented before me, particularly the nursing notes from Petitioner's staff, paints a particularly clear picture of R3's observed behavior throughout her stay at Petitioner's facility, and of the facility's responses to what it, through its staff, observed. Thus, a close review and discussion of those records is the appropriate first step here.

Initially, R3 was moaning when an assessment was done on May 23, 2000 and saying that "no, my clothes are coming off." She was oriented only to herself. P. Ex. 15, at 1. During a breathing treatment on May 27, 2000, R3 was constantly pulling at her breathing mask and saying "no, take this off . . . ." P. Ex. 3, at 3. R3 was noted to be "hollering" and moaning at various times on May 29, 2000. P. Ex. 15, at 4. R3 was "yelling loudly" on May 30, 2000. Id. at 5.

On May 31, 2000, Trazadone (4) was ordered for R3. This drug is an antidepressant but has a strong side effect of causing drowsiness. Trazadone is not considered an antipsychotic drug. Trazadone was prescribed by Dr. Wootan (R3's attending physician) to R3 "for rest." P. Ex. 14, at 3; Tr. 274. Dr. Wootan testified that the reason he prescribed Trazadone was because R3 spent several nights during which she was not sleeping and she was also not sleeping during the day. Tr. 274. Evidence was presented that R3 had appeared to be agitated, distressed, and upset at times, "crying," "yelling," "whining," and moaning during the night. P. Ex. 15, at 4 - 5.

Dr. Wootan testified that he ordered the Trazadone to promote rest and avoid the adverse consequences of sleeplessness. Tr. 274, 276. Dr. Wootan is a board-certified geriatric specialist with special training and experience in the use of psychoactive medications and because antipsychotic medications. Tr. 260 - 65. At the hearing, Dr. Wootan testified as an expert in medicine with a special expertise in psychoactive medications. Tr. 266. Dr. Wootan testified that he had adequate information from the nursing staff about R3 to allow him to make an appropriate informed judgment to prescribe the Trazadone that R3 needed. Dr. Wootan was satisfied that the nurses had performed a sufficient assessment of R3 prior to his prescribing Trazadone. Tr. 272 - 75.

After the Trazadone was initiated, R3's crying and agitated behaviors continued. P. Ex. 15, at 6 - 8. On June 1, 2000, R3 was up in a gerichair "crying and yelling constantly in a high pitched voice." Id. at 6. On June 2, 2000, R3 continued to call and cry out when awake. Id. at 8. On June 3, 2000, R3 was noted to be moaning. Id. On June 5, 2000, R3 was "restless and yelling" at times during the evening and night. P. Ex. 15, at 7. Between June 6 - 8, 2000, R3's condition improved. However, R3 had an episode of "usual yelling" and was "talking about grapes and bananas" on June 10, 2000. Id. at 11. On June 11, 2000, R3 was confused as to time and place and displayed "intermittent monotone yelling." Id. at 12.

On June 12, 2000, R3 was first prescribed Zyprexa, an antipsychotic drug. CMS Ex. 23, at 3. The order was taken by a nurse over the telephone and the diagnosis documented on the order was for "psychosis." Id. at 6. There was some confusion in the testimony concerning why this drug was ordered. The telephone order documented that the drug was ordered for psychosis. Dr. Wootan testified that Zyprexa was ordered primarily for sleep. Tr. 293 - 97. Dr. Wootan also stated that R3 had Alzheimer's dementia which he regarded as a form of psychosis. Tr. 280. Dr. Wootan further testified that he used the DSM-IV code for "dementia." Tr. 329. According to Dr. Wootan, R3's behavior was "out of touch with reality" which he characterized as the definition of psychosis. P. Ex. 24; Tr. 280, 296 - 99. Dr. Kraft, R3's attending physician during the latter part of R3's stay at the facility, testified that, in his opinion, a diagnosis of Alzheimer's dementia is not the same as a diagnosis of psychosis. Tr. 516 - 17. However, Dr. Kraft also characterized R3's behavior as psychotic. Tr. 497, 514 - 16. Even Mr. Box, the surveyor, conceded that the record illustrated that R3 suffered from delusions, yelling, sleeplessness, and "disordered thinking." Tr. 65, 66, 103, 104, 211, 239, 292.

On June 12, 2000, Dr. Wootan gave a telephone call order for 2.5 mg. of Zyprexa to be given at bedtime for "psychosis." P. Ex. 14, at 6; P. Ex. 15, at 12. When asked how long he would expect to wait and see whether R3's previous medication was working before deciding to try something else, Dr. Wootan testified: "A couple of things would be involved. If the symptoms were improving over a period of time, then you'd probably want to continue to see how long you could go with the medication and how much improvement you could get with it, and that would be up to probably seven to ten days." Tr. 276. Dr. Wootan considered Zyprexa an appropriate medication for R3 and he specifically testified that he obtained adequate information about R3's condition and needs from the facility and its staff before ordering the Zyprexa. Tr. 276, 278. June 12, 2000, the day that Zyprexa was initiated, was the date CMS determined that Petitioner went out of compliance with Medicare and Medicaid participation requirements. Zyprexa is considered an antipsychotic drug by CMS and is so listed in the State Operations Manual. However, both Dr. Wootan and Dr. Kraft testified that the Food and Drug Administration no longer considers Zyprexa to be an antipsychotic drug but rather considers it to be a psychotropic drug. Tr. 267, 502. Further, the parties are in agreement that a dosage of 2.5 mg. Zyprexa is a low dosage.

On June 13, 2000, R3 was noted making "whining" and "crying" sounds when her vital signs were taken. CMS Ex. 39, at 4. On June 14, 2000, R3 continued calling out in a monotone and wanted staff to look at "the baby." Id. Also, on June 14, 2000, R3 was awake and "yelling" at 1:30 a.m. P. Ex. 15, at 14. On June 15, 2000, R3 was crying out at times and wanted to see her dead husband and was also noted being anxious and upset. Id. at 16. R3 was "yelling" on June 18, 2000. Id. at 17. On June 19, 2000, Dr. Wootan was faxed a report by a nurse that R3 had been "hollering all night" and that her medications did not seem to be working. Id. at 14 - 15. Later that same day, Dr. Wootan issued new orders to increase Zyprexa to three times a day. At the same time, Dr. Wootan ordered that in one week the Trazadone should be increased to 100 mg. at 9 a.m. and 150 mg. at 9 p.m. P. Ex. 14, at 7. Dr. Wootan testified that he ordered the increase in medication because R3 was not getting adequate rest and that the lower dose was not having a therapeutic effect. Tr. 303 - 04. R3 continued "yelling" on June 20 and 21, 2000. P. Ex. 15, at 18; CMS Ex. 39, at 9. R3 experienced lethargy and was unable to take her medications, her meal, or fluids on June 22, 2000. At 6 p.m. on June 22, 2000, a nurse contacted Dr. Wootan about R3's condition. Dr. Wootan ordered that Zyprexa be held for five days and to resume after five days at a dosage of 2.5 mg. each night. P. Ex. 14, at 9; P. Ex. 15, at 19. On June 23, 2000, the resident's lethargy and poor appetite continued. Id. Again, a nurse faxed Dr. Wootan about R3's lethargy. New orders were received that the medications, Zyprexa and Trazadone, should be held until R3 was more responsive. The new orders further stated that when R3 was more responsive, Zyprexa should be started again at a dosage of 2.5 mg. each night and that the Trazadone was to be discontinued. P. Ex. 14, at 10. Because Trazadone was discontinued on June 23, 2000, Dr. Wootan's earlier order to increase Trazadone one week after June 19, 2000 never went into effect.

On June 24, 2000, R3's lethargy and somnolence continued. P. Ex. 15, at 20 - 21. On June 25, 2000, R3 was starting to be more alert. R3 was "yelling" during a nursing assessment and calling out occasionally. No hallucinations and no signs or symptoms of any acute distress were noted. Zyprexa was not given to R3 on June 25, 2000. Id. at 21 - 22. R3 was noted to be awake and alert, but confused on June 26, 2000. R3 was confused, spoke of "everything being arsenic," had a poor appetite, and began a "high pitched monotone cry." Id. at 22 - 23. A physician's order on June 26, 2000, discontinued Zyprexa completely. Instead, Risperdal, a medication used for agitation in demented patients, was ordered at a dosage of 0.5 mg. twice a day for June 27, 1 mg. twice a day for June 28, and then 2 mg. every morning starting June 29, 2000. P. Ex. 14, at 10. R3 was awake but still somnolent on June 27, 2000. On June 28 and 29, 2000, R3 rested quietly. On June 29, 2000, R3 started to received 0.5 mg. Risperdal at night. This dosage of Risperdal continued until R3 was discharged on July 24, 2000.

Nursing notes during the last days of June and the beginning of July indicate that R3's condition continued to be marked by persistent shouting and crying out, insomnia, agitation, and intermittent lethargy. P. Ex. 15, at 28 - 34. On July 8, 2000, R3 roused easily. On July 9, 2000, R3 responded to stimuli. On July 13, 2000, R3 was resting quietly. On July 14 and 15, 2000, R3 was alert and oriented. On July 16, 2000, her eyes were brighter. On July 17, 2000, her condition seemed improved. On July 18 - 20, 2000, R3 was alert and oriented. She was also alert and oriented on July 22, 2000. P. Ex. 15, at 35 - 51. These assessments show, and Dr. Kraft testified, that the Risperdal was helping R3. Tr. 508, 511. R3 was discharged to the hospital on July 24, 2000, which was the date set by CMS as the time at which the period of alleged immediate jeopardy ended.

The evidence shows that adequate formal and informal assessments were done on R3 by the facility and its staff. Informal assessments were done as demonstrated by the nursing notes discussed above. An admission assessment documented that R3 had an acute respiratory infection, Alzheimer's disease, Parkinson's disease, aphasia, and suffered from several other problems as well. P. Ex. 6. An initial rehabilitation assessment was completed on the day following admission. P. Ex. 16, at 1. On May 23, 2000, the facility completed a Nutritional Assessment. Petitioner completed an initial care plan shortly after admission. P. Ex. 12. On or about June 8, 2000, the facility completed a comprehensive assessment referred to as a Resident Assessment Protocol. CMS Ex. 20. On June 5, 2000, the facility completed a hydration risk assessment. P. Ex. 8. On June 6, 2000, the facility arranged for a modified barium swallow test. P. Ex. 10. The facility also initiated physical therapy, occupational therapy, and speech therapy. On June 8, 2000, the facility completed a comprehensive care plan which noted Alzheimer's disease, impaired mood state, episodes of crying, whining and restlessness, depression, compromised nutritional status, risk for skin breakdown, respiratory problem, and other problems. This comprehensive care plan, which was continually updated, also noted the use of Trazadone and Zyprexa and noted that certain side effects were possible. P. Ex. 13. Another nutritional assessment was done on July 7, 2000. P. Ex. 11. There were two Minimum Data Set forms completed by the facility for R3 dated June 20, 2000 and July 11, 2000. CMS Exs. 18, 19.

CMS argues that Petitioner failed to comply with 42 C.F.R. � 483.25(l)(2)(i) because Petitioner failed to conduct a comprehensive assessment of R3 which clearly showed that antipsychotic drugs were necessary to treat a specific condition as diagnosed and documented in her clinical records, prior to and following the initiation of antipsychotic drugs. CMS's argument ultimately is based on two points. The first is the failure of Petitioner to do what CMS considers to be a comprehensive assessment. The second is the failure of the facility to specifically document the condition it was trying to address with the use of antipsychotic drugs and the failure to show that antipsychotic drugs were necessary to treat that condition.

As to the second point, CMS never argues that the use of antipsychotic drugs for R3 was inappropriate. Although CMS argues that the facility failed to document the condition that it was trying to address, it seems instead more accurate to understand that the facility really had to consider several conditions from which R3 was possibly suffering, all of which would make the use of antipsychotic drugs appropriate. CMS concedes that antipsychotic drugs are appropriate for individuals who have DSM-IV coded dementia or organic mental syndrome with associated psychotic and/or agitated behaviors. CMS's Post-Hearing Brief at 15. In fact, Dr. Wootan testified that he used the DSM-IV code for dementia. Tr. 329. "Crying," "yelling," "whining," and "moaning" can qualify as agitated behaviors. In addition, there were 42 instances of R3 experiencing delusions documented in July 2000. Tr. 239; CMS Ex. 28. At various times, R3's complex problems were diagnosed as Alzheimer's dementia, organic brain syndrome and an impaired mood state. Furthermore, both Drs. Wootan and Kraft characterized R3's behavior as psychotic. Even after R3 was discharged from Petitioner's facility, R3 continued to receive antipsychotic medication (Risperdal) at the hospital. There seems to be no room for reasonable doubt that R3 exhibited psychotic behavior and that the use of antipsychotic medication was appropriate.

Therefore, CMS's main point is that there was a "lack of assessment" done prior to initiating these antipsychotic drugs. The regulation at section 483.25(1)(2)(i) does not specify a prescribed form or format to use to make the assessment required prior to administering antipsychotic drugs. Connie Stacy, R.N., who was accepted as an expert in the application of the requirements of participation in the Medicare and Medicaid programs, characterized the requirement in section 483.25(l)(2)(i) as a "prudent and comprehensive look at the resident's needs for the drug before it is administered." Tr. 572. According to Nurse Stacy, the assessment required by the regulation can be reflected as the sum of information from multiple sources not limited to formal assessments, and can include information from a Minimum Data Set, care plan, admission evaluation, nursing notes, medication administration records, flow sheets, notes from other professional areas, and nurses' communications, either oral or written, with a physician. Tr. 564 - 67. In addition, Nurse Stacy testified that the standard of nursing practice governing nurse communications with physicians requires a nurse to be familiar with a resident's current condition, as well as pertinent parts of the resident's medical record, so that a nurse can bring pertinent information to a physician's attention. Tr. 567 - 68. R3's physicians had obviously received information about R3's condition orally from the facility's staff either in person or by telephone. Finally, Nurse Stacy specifically testified that the assessments documented in R3's medical records were adequate for this purpose because she could determine from the medical records R3's conditions, needs, and responses to treatment. Tr. 569, 571 - 72.

I agree that the regulation does not contemplate some specific form or document that memorializes some specific assessment. CMS never specifically indicated what the regulation required and the regulation is itself silent on that point. The regulation uses the term "comprehensive assessment" but nowhere is this term described or defined. Although it seems that the surveyor involved in this case was looking for an assessment in the form of some particular but still-unspecified documents, which CMS could not at the time and still cannot identify, the parties agree that a comprehensive assessment can take many forms and is not any specific document. The parties agree that "comprehensive assessment" is not specifically defined in the regulation at issue. Nurse Stacy, qualified, accepted, and giving her opinion as an expert, testified that a comprehensive assessment can be a collection of data from many sources. CMS quoted Nurse Stacy's statement in its brief and agreed that a comprehensive assessment "can take many forms and is not one specific document." CMS Post-Hearing Brief at 8 - 9. It would therefore seem difficult for the parties to find serious disagreement with my conclusion that the regulation does not contemplate some specific form or document that memorializes some specific assessment.

Most importantly, both Dr. Wootan and Dr. Kraft testified that they were satisfied that the facility's staff had communicated to them all the information they required about R3's condition to make informed professional decisions concerning R3's treatment. Tr. 272 - 74, 275, 281, 284, 290, 292, 304, 323 - 24, 490 - 93, 511 - 12. Dr. Wootan and Dr. Kraft were both very persuasive; their testimony quite correctly commands great weight, given their professional qualifications and their familiarity with the circumstances of this case. For example, it is impossible to mistake either the vigor of Dr. Wootan's opinion or the soundness of his reasoning in reaching it:

Q: Now, in your answer you used the word "assessment" a number of times. What do you in your mind when you're communicating with a nurse understand to be a nursing assessment?

A: The impression that they have from what they see, hear, maybe even feel in relation to the condition of the patient. They transmit that information to me in their most meaningful way. I ask additional questions, and it's not at all uncommon for me, if I come to a -- say, I'm going to suggest a change in order, it is not uncommon for me to ask the nurse if that is also fitting with how she is assessing the problem, so that we can make sure that we are communicating in the same way.

Q: All right. Now, we know that the resident at issue in this case was admitted to the Grace facility on May 23, 2000, and we know that on May 31, 2000, you gave an order for a medication called Trazadone, quote/unquote, for rest. Do you recall the circumstances under which you gave that order?

A: Yes. The patient was not sleeping. She came in cachectic, losing weight, had been in the hospital for pneumonia, and had had several nights in which she was not sleeping and also not sleeping during the day. This is not consistent with wellness, and so -

Q: Now, let me interrupt you for a moment. How did you know that information?

A: From the assessments made by the nursing staff and communicated to me.

Q: Now you're beginning to tell us the significance of this information to you in your decision-making process.

A: Yes.

Tr. 273-75.

Q: Were you satisfied that the nursing staff had assessed the resident's condition and response to the medications she was receiving adequately enough for you to make an appropriate professional judgment?

A: Yes, sir.

Tr. 281.

Q: And, again, I'll ask you the question: Were you satisfied with the information that was provided by the nursing staff, that provided you an adequate basis to make a professional judgment to order that medication?

A: Yes, sir.

Tr. 284.

Dr. Kraft's opinions were completely consistent with those of his sometimes-colleague, Dr. Wootan. That consistency lends credibility to both doctors' testimony, as does the consistency of the thinking underlying the opinions themselves. Dr. Kraft said the following:

Q: Now, from your perspective as a physician, do you have an opinion as to the adequacy of the assessments made by the nursing staff at Grace Living Center as reflected in the medical record as a foundation for use of the Zyprexa and the Risperdal?

A: Yes.

Q: And what is that opinion?

A: I think the documentation and the care of the patient regarding the Zyprexa was fine.

Q: And with respect to the Risperdal also?

A: Yes, sir.

Q: And that would be your same answer, that it would be fine?

A: It was fine.

Q: Did it, in your opinion as a physician, meet the standard of care for nursing facilities in this area, so far as you know it, based on your experience as a medical director?

A: In this area, yes, and also nationally, yes.

Tr. 511-12.

This is testimony to which I must defer, and by which I am bound to be persuaded. CMS failed to show how the information described by the facility's staff and received by R3's doctors was deficient, or how R3's symptoms were in any way incompatible with the medications ordered. Both of her doctors, Dr. Wootan and Dr. Kraft, were firm, unambiguous, and ultimately persuasive in their expressed views that antipsychotic drugs were appropriate for R3, and that they as her physicians had adequate information, based on adequate nursing assessments, to form that medical judgment. R3 exhibited psychotic behavior and was not "connected with reality." Tr. 457. In fact, when R3 was discharged from the facility and transferred to St. John's Hospital, the doctors at St. John's Hospital continued to medicate R3 with Risperdal. There is also significance in the fact that during this survey, the surveyor conducted a closed record review and did not interview either of R3's attending physicians, and did not inquire about the quality or quantity of the information they had received from the facility regarding R3's condition or behavior, the clinical significance and sufficiency of that information, or their reasons for ordering the medications. Nor did the surveyor interview any of R3's nurses regarding any assessments that they did, or the nature, content, and timing of their communications with R3's physicians. Tr. 172, 209, 224.

Although I can find no case directly on point, other cases interpreting 42 C.F.R. � 483.25(l), of which section 483.25(l)(2)(i) is a subsection, support my reading of the regulation. In Palm Beach County Home, DAB CR831 (2001), the ALJ stated that "there is no requirement in the regulation that a facility record the absence of side effects of a medication on a particular form. The regulation contains no documentation requirements. It requires that there be 'adequate monitoring' of drug use without specifying how monitoring is to be conducted or documented." Palm Beach County Home, DAB CR831, at 13. Further, the ALJ found that the physician in Palm Beach County Home received information about side effects directly from Petitioner's staff and that was sufficient for the regulations. Id. at 14. Further, in Ontario Care Center, DAB CR713 (2000), the ALJ stated that, "[t]he regulation [42 C.F.R. � 483.25(l)] neither states nor suggests that a facility will be held strictly liable for noncompliance if it fails to engage in periodic reviews of its residents' medication use," and that the "periodic review for necessity" is a general requirement. Ontario Care Center, DAB CR713, at 18. In Libbie Convalescent Center, DAB CR589 (1999), the ALJ stressed that the facility was in substantial compliance because although the description of a resident's condition was very concise, given the staff's familiarity with the resident and the testimony of the resident's physician, the ALJ was convinced that Petitioner in that case did not administer the antipsychotic medication without adequate indications for its use. Also, in Libbie, when discussing resident assessments under a different section of the regulations, the ALJ held that information can come from many sources, including oral communications. Libbie Convalescent Center, DAB CR589, at 29.

Given the totality of the information made available to R3's physicians from all sources, both formal and informal: Dr. Wootan's and Dr. Kraft's own testimony that they were satisfied that the facility's staff had communicated to them all the information they required to make informed professional decisions concerning R3's treatment; the credible and persuasive testimony of Nurse Stacy, whose expertise is conceded by both parties; and my own reading of the requirements of the regulation that a comprehensive assessment can be a collection of data from many sources, I find that Petitioner provided R3's physicians with an ongoing comprehensive assessment of R3's condition. Although CMS argues that some of these formal assessments were not complete, it is evident to me that Petitioner was continually noting R3's condition and was transmitting that information to R3's physicians. My ruling today should not be understood as holding that the facts CMS has proved here could never support a finding of deficiency based on 42 C.F.R. � 483.25(l)(2)(i). As I have been careful to point out above, I believe that CMS has established its case prima facie, but I am persuaded that Petitioner has successfully refuted that prima facie case.

2. CMS was not authorized to impose a CMP because I have found Petitioner in substantial compliance with participation requirements.

Since Petitioner was in substantial compliance with program requirements, CMS was not authorized to impose a CMP. The issue of the proposed CMP's reasonableness is moot.

IV. Conclusion

I find no basis for the imposition of a CMP from June 12, 2000 through July 24, 2000 because Petitioner was in substantial compliance with Medicare and Medicaid requirements.

JUDGE
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Richard J. Smith

Administrative Law Judge

FOOTNOTES
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1. Since "HCFA" was used to refer to the agency at the time that the actions at issue were taken, references from documents use the old acronym. However, for the sake of clarity, I will refer to the governmental entity and any related documentation as "CMS."

2. The deficiency cited under at 42 C.F.R. � 483.25(l)(2)(i) is the sole basis for the CMP that CMS is seeking to impose against Petitioner.

3. Mr. Glenn Box, the chief surveyor, conceded that he never interviewed either of R3's attending physicians or any of R3's nurses. Transcript (Tr.) 172, 209.

4. Trazadone is also known as Desyrel or Desaril.

CASE | DECISION | JUDGE | FOOTNOTES