CASE | DECISION | JUDGE

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


SUBJECT:

Palm Beach County Home,

Petitioner,

DATE: October 25, 2001
                                          
             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No.C-99-102
Decision No. CR831
DECISION
...TO TOP

 

DECISION

I find that there is no basis to impose against Petitioner, Palm Beach County Home, the remedy of denial of payment for new Medicare admissions for the period which ran from August 18, 1998 through August 31, 1998.

I. Background

Petitioner is a skilled nursing facility that is operated by a government entity, the Health Care District of Palm Beach County, Florida. Its resident population consists of individuals who need long-term care but who are somewhat atypical of the population of other nursing facilities. The residents tend to be younger individuals, some of whom have substance abuse problems, or who are homeless, or who lack health care insurance.

A compliance survey of Petitioner was conducted on June 11, 1998 by representatives of the Florida Agency for Health Care Administration (Florida State survey agency). The surveyors concluded that Petitioner was not complying substantially with three federal participation requirements that are contained in the federal regulations at 42 C.F.R. Part 483. The Centers for Medicare & Medicaid Services (CMS) accepted these findings and determined to deny payment to Petitioner for new Medicare admissions for the period which ran from August 18, 1998 through August 31, 1998.

Petitioner requested a hearing. I conducted an in-person hearing in West Palm Beach Florida on June 26, 2001. At that hearing I received the testimony of several witnesses. Additionally, I received into evidence exhibits offered by the parties. From CMS, I received into evidence exhibits that were identified as CMS Ex. 1, CMS Ex. 16, CMS Ex. 17, and CMS Exs. 21 - 26. From Petitioner, I received into evidence exhibits that were identified as P. Exs. 1 - 4, P. Exs. 6 - 10, and P. Exs. 12 - 23.

At the hearing CMS identified two additional exhibits, CMS Ex. 6 and CMS Ex. 7, which it evidently intended to offer into evidence but which it failed to offer. Petitioner did not object to my receiving these exhibits into evidence. I now receive them into evidence in order to complete the record in this case. I also note that both parties have submitted documents with their posthearing briefs in the nature of attachments or appendices. Neither party requested that these be identified as exhibits and I neither identify the documents as exhibits nor do I receive them into evidence.

At the completion of the hearing, I established a briefing schedule and I imposed page limits on the parties for their posthearing briefs and reply briefs. I allowed each party a total of 40 pages for its posthearing brief and reply brief. Petitioner complied with that directive. However, CMS submitted a posthearing brief of 35 pages and a posthearing reply brief with nine pages of text. CMS's submission exceeds my page limitation by a total of four pages. Petitioner objected and moved that I not consider the arguments CMS made in those pages of its posthearing reply brief that are beyond the 40-page limit. I deny this motion. I have decided this case in Petitioner's favor on the merits and I do not find that the interests of justice would be served further by imposing sanctions against CMS.

II. Issue, findings of fact and conclusions of law

A. Issue

The issue is whether there is a basis to deny payment to Petitioner for new Medicare admissions for the period which ran from August 18, 1998 through August 31, 1998.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separately numbered heading. I discuss each Finding in detail.

1. A basis would exist to deny payment to Petitioner for new Medicare admissions for the August 18 - 31, 1998 period if Petitioner failed to comply substantially with one or more federal participation requirements during that period.

CMS would be authorized to deny Petitioner payment for new Medicare admissions for the August 18 - 31, 1998 period if Petitioner failed to comply substantially with one or more federal participation requirements during that period. 42 C.F.R. § 488.417(a)(1). The term "substantial compliance" is defined to mean:

a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health and safety than the potential for causing minimal harm.

42 C.F.R. § 488.301.

2. Petitioner did not fail to comply substantially with a federal participation requirement during the August 18 - 31, 1998 period.

CMS based its remedy determination in this case on deficiency findings that were made at the June 11, 1998 survey of Petitioner. The deficiency findings were reported by the Florida State survey agency as alleged failures to comply with the requirements of: 42 C.F.R. §§ 483.12(a)(2) and (3); 483.13(c)(1)(i); and, 483.25(l)(1). HCFA Ex. 23. Below, I discuss separately each deficiency allegation and Petitioner's response to that allegation. I conclude that in some respects CMS failed to establish a prima facie case that Petitioner failed to comply substantially with participation requirements. In all other respects, Petitioner rebutted the evidence of noncompliance that CMS offered by a preponderance of the evidence

a. Petitioner proved by the preponderance of the evidence that it complied substantially with the requirements of 42 C.F.R. § 483.12(a)(2) and (3).

The report of the June 11, 1998 survey alleges, at Tag 201, that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.12(a)(2) and (3). HCFA Ex. 23 at 1 - 5. At 42 C.F.R. § 483.12(a)(2), the regulation defines the circumstances under which a facility may transfer or discharge a resident from its premises. At 42 C.F.R. § 483.12(a)(3), the regulation prescribes documentation requirements which a facility must comply with when it transfers a resident.

Although the survey report cites to both subsections of the regulation it does not describe any alleged failure by Petitioner to comply with the documentation requirements of 42 C.F.R. § 483.12(a)(3). See HCFA Ex. 23, at 1 - 5. All of the narrative allegations in the survey report relate to the alleged failure by Petitioner to comply with the transfer and discharge criteria that are in 42 C.F.R. § 483.12(a)(2). The report alleges that Petitioner transferred a resident - who is identified in the survey report as Resident # 2 - from its premises to a Salvation Army facility without satisfying any of the transfer or discharge criteria that are described in that section.

Resident # 2 was admitted to Petitioner's facility from a hospital on August 29, 1997. He remained there until his discharge on May 26, 1998. During his stay at Petitioner's facility the resident was recovering from injuries which included a closed head injury and a fractured tibia. HCFA Ex. 23, at 2.

Resident # 2's stay at Petitioner's facility was marked by altercations between the resident and other residents, between the resident and members of Petitioner's staff and, by the resident's refusal to comply with facility procedures. Resident # 2's conduct was increasingly disruptive in the days that immediately predated his discharge from the facility. On May 22, 1998, two female residents complained that Resident # 2 attempted to assault them in their rooms. P. Ex. 1, at 342. On May 23, 1998, the resident was visibly intoxicated and smelled of alcohol. Id. at 343. The resident caused other residents to become agitated on that date. Id. On May 24, 1998, the resident left his assigned area in the facility without signing out. When staff confronted him about this violation of procedure, the resident averred that he would not sign any papers and asserted that no one could compel him to do it. Id.; P. Ex. 1, at 7.

These episodes climaxed on May 25, 1998, the day before the resident's discharge. On that date the resident fought with another resident in the breeze way of Petitioner's facility. P. Ex. 1, at 343. During this altercation, Resident # 2 struck the other resident with his belt. Id. at 33. Petitioner's staff told Resident # 2 to return to his room but he refused this directive. He then threw a piece of wood, striking and injuring a member of Petitioner's staff. Id. at 343. The resident remained hostile after being returned to his room and refused to take his medications. Id. On May 26, 1998 a clinical psychologist evaluated the resident and reported the following conclusion:

This patient's behavior has been resistant and disruptive. In my opinion, this individual is likely to remain aggressive with little impulse control. Perhaps a different type of facility might be useful for this particular individual.

P. Ex. 1 at 33.

Petitioner decided to discharge the resident based on his behavior during the days that immediately predated May 26, 1998 and on the clinical psychologist's evaluation of May 26, 1998.

At the time of his discharge Resident # 2's medical condition had improved significantly. He was not complaining of pain at the time of his discharge. See P. Ex. 1, at 468. The resident was capable of changing the dressing to his leg wound. Tr. at 170. There was no evidence of infection at the site of the resident's leg wound. Tr. at 187; 202. The resident's treating physician concluded that the resident did not need skilled nursing care at the time of his discharge. Id. at 187.

CMS argues that Petitioner's decision to transfer Resident # 2 from its premises to a Salvation Army facility was not justified. It contends that the resident was not medically suitable for a transfer or discharge. According to CMS, the resident had a possible infection in his leg that continued to require care in a residential setting. CMS argues, additionally, that the resident was receiving medications, Risperdal and Dilantin, that could only be administered and monitored in a residential environment.

CMS concedes that the resident's behavior shortly prior to his discharge was disruptive. However, CMS argues that the resident was not so disruptive as to endanger the safety of other persons. CMS contends that Petitioner should have found ways to accommodate the resident, particularly in light of the atypical nature of the population of Petitioner's facility. It asserts that Petitioner should have been adept at handling younger and potentially disruptive individuals such as Resident # 2.

Finally, CMS asserts that Petitioner was obligated to retain Resident # 2 because there was no suitable alternative residential setting available for the resident where the resident's medical needs could be attended to. CMS contends that, if Petitioner wanted to discharge the resident, Petitioner had a duty to orient the resident for discharge and to find a suitable facility for that resident.

The permissible grounds for transferring or discharging a resident from a facility include the following:

• The transfer or discharge is necessary for the resident's welfare and the resident's needs cannot be met in the facility.

• The transfer or discharge is appropriate because the resident's health has improved sufficiently so the resident no longer needs the services provided by the facility.

• The safety of individuals in the facility is endangered.

42 C.F.R. § 483.12(a)(2)(i), (ii), (iii). The presence of any of these grounds will justify a transfer or a discharge. The presence of all or more than one of these grounds is not necessary.

The weight of the evidence establishes - CMS's arguments notwithstanding - that the criteria of 42 C.F.R. § 483.12(a)(2)(ii) and (iii) were satisfied in this case. The primary reason for Petitioner's discharge of Resident # 2 was that he posed a serious threat to the safety of Petitioner's staff and other residents. 42 C.F.R. § 483.12(a)(2)(iii). It is also true that the resident's medical condition had improved sufficiently to justify his discharge. 42 C.F.R. § 483.12(a)(2)(ii).

Petitioner justifiably transferred Resident # 2 because his continued presence at Petitioner's facility endangered the safety of other residents and Petitioner's staff. The resident perpetrated increasingly violent assaults against other residents and facility staff in the three days prior to his discharge. His conduct included: attempted assaults of female residents; an assault of another resident with a weapon (his belt); and, an assault of a staff member with a piece of wood. The resident proclaimed openly that he would not follow facility procedures and he refused staff direction and medical treatment. A clinical psychologist concluded that the resident was likely to remain aggressive. P. Ex. 1, at 33.

CMS contends that Petitioner should have found ways to accommodate Resident # 2 despite his assaultive behavior. It asserts that the resident was not atypical of the Petitioner's resident population and "seemed to fit within [Petitioner's] self described care capabilities." CMS's posthearing brief at 19. It argues that Petitioner made no efforts to deal with the resident's disruptive behavior "other than to place him on a behavior altering medication and send him to the facility psychologist on two occasions for admonishment." Id. CMS contends also that Petitioner did not prepare a new care plan to deal with the resident's aggressive behavior.

I am not persuaded by these arguments. CMS has offered no evidence to show that Petitioner's behavior was typical of that of other residents in Petitioner's facility. But, Petitioner would have been justified in transferring or discharging the resident even if his behavior was typical of that displayed by other residents. A facility is not compelled to keep a dangerous resident because other residents might also be dangerous.

Petitioner was not obligated to make efforts to accommodate Resident # 2 once it became apparent that the resident threatened other individuals' personal safety. The regulations do not impose on a facility the duty to engage in heroic efforts to retain a resident who poses a clear and present danger to other residents or to the facility's staff. Petitioner had no obligation to prepare an additional care plan or to attempt alternative treatments. Indeed, the fact that Petitioner attempted to deal with the resident's behavior with psychological evaluation and medication suggests that it was doing more than it was required to do for the resident.

It is also evident that, by the date of his discharge, Resident # 2 had improved sufficiently so that he no longer needed the skilled nursing care that Petitioner provided. On this issue, I find to be persuasive the testimony that was offered by Petitioner's medical director, Jaimy Bensimon, M.D. Tr. at 183 - 187. Dr. Bensimon is board-certified in internal medicine, cardiology, and geriatric medicine. Id. at 183. He testified, credibly, that at the time of his discharge Resident # 2 was totally independent, no longer needed custodial care, and was capable of changing his own bandages. Id. at 187.

None of the resident's medical records show that the resident was suffering from an infected leg wound. P. Ex. 1. The fact that the leg wound may have continued to emit a discharge is not sufficient, in and of itself, for me to infer that it was infected or that Resident # 2 continued to require in-patient care to treat that wound. CMS did not offer any expert medical testimony that established that the resident's leg wound was infected. And, although the resident may have required monitoring by a physician to assure that he was responding appropriately to his medications and was not experiencing adverse side effects from them, there is no evidence in the record to support a conclusion that the monitoring had to be provided on an in-patient basis.

CMS's arguments about the need to continue to house Resident # 2 at Petitioner's facility reduce to the contention that the resident would have received a better quality of medical care at the facility than he received outside of the facility. That may be true. But it begs the question of whether the resident's medical condition had improved sufficiently to justify his discharge. A facility is not required to provide continuing residential care to an individual because that individual might receive better care in that facility than he or she would receive in some other setting.

In its reply brief, CMS cites to 42 C.F.R. § 483.12(a)(2)(i) and asserts that this subsection compelled Petitioner to retain Resident # 2 on its premises. CMS argues that Petitioner could not lawfully transfer or discharge Resident # 2 because Petitioner did not establish that it was unable to meet the resident's needs. CMS interprets the language of 42 C.F.R. § 483.12(a)(2)(i) to mean that a transfer will never be appropriate unless a resident's needs cannot be met by a facility. CMS's reply brief at 1 - 2. This is an incorrect reading of the regulation. Subsection (a)(2)(i) provides one basis for a transfer. It applies to the circumstance where a facility determines that a resident's needs cannot be met by that facility. However, it does not suggest that a facility is obligated to retain a resident if a resident's needs can be met by the facility. Nor does it override all of the other subsections of 42 C.F.R. § 483.12(a)(2), which describe other circumstances in which a transfer or discharge of a resident is appropriate. CMS's proposed interpretation would read these other subsections out of the regulation.

CMS is also incorrect to assert that there is a post-discharge orientation requirement in 42 C.F.R. § 483.12(a)(2). That section does not contain such a requirement. Therefore, the possibility that Petitioner may have failed to provide Resident # 2 with post-discharge orientation is irrelevant. There is a requirement for post-discharge orientation in 42 C.F.R. § 483.12(a)(7). However, the survey report of June 11, 1998 does not allege that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.12(a)(7). At no time prior to the hearing did CMS move to amend its allegations to include an allegation that Petitioner failed to comply with 42 C.F.R. § 483.12(a)(7). CMS made the allegation of failure to provide post-discharge orientation for the first time in its posthearing brief. CMS's posthearing brief at 16. I decline to amend the issues in this case to include an allegation that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.12(a)(7) because to do so at this late date would be unfair to Petitioner.

b. CMS did not present a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c)(1)(i).

The report of the June 11, 1998 survey alleges, at Tag 224, that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c)(1)(i). HCFA Ex. 23, at 5 - 9. The regulation states that a facility must:

[n]ot use verbal, mental, sexual or physical abuse, corporal punishment, or involuntary seclusion . . . .

42 C.F.R. § 483.13(c)(1)(i).

I find that CMS did not present a prima facie case that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c)(1)(i). Below, I discuss in detail the specific reasons for my reaching this conclusion. I address each of CMS's arguments, one by one, and find them to be without merit or without evidentiary support. However, it is apparent that CMS's analysis of Petitioner's alleged failure to comply with the requirements of 42 C.F.R. § 483.13(c)(1)(i) rests, at bottom, on a misunderstanding of what this regulation is intended to address.

CMS argues in this case that Petitioner is deficient because it did not deal with the assaultive and obstructive behavior of Resident # 2 as if it were abuse covered by 42 C.F.R. § 483.13(c)(1)(i). The fundamental problem with this argument is that the regulation does not apply to the assaultive and obstructive conduct that resident # 2 engaged in. 42 C.F.R. § 483.13(c)(1)(i) plainly and simply prohibits a facility and its staff from abusing residents. That is obvious from the language of the subsection, which says that the facility must not use verbal, mental, sexual or physical abuse, corporal punishment, or involuntary seclusion. There is no language in the subsection which suggests that it is intended to deal with resident-against-resident assaults.

That is not to suggest that a facility has no duty to supervise its residents and to take appropriate action to prevent or to stop resident-against-resident assaults. A facility clearly has such a duty under another regulation, 42 C.F.R. § 483.25(h)(2). Woodstock Care Center, DAB No. 1726 (2000). I would have considered whether CMS offered sufficient evidence to establish a prima facie case of noncompliance with the requirements of 42 C.F.R. § 483.25(h)(2) if CMS had alleged that Petitioner failed to discharge its obligation to its residents under this regulation. But, at no time did CMS make this allegation. I find it to be inappropriate, on my own motion, to amend CMS's allegations after the hearing is completed and the evidentiary record is closed to raise the allegation of a failure by Petitioner to provide adequate supervision of Resident # 2 in order to prevent accidents.

Turning to CMS's specific allegations of noncompliance, I find them to be without merit. At the hearing one of the surveyors who conducted the June 11, 1998 survey alleged that the surveyors had requested Petitioner's staff to produce a copy of its policy concerning abuse but that the staff had failed to do so. Tr. at 73. This allegation is not made in the survey report and, therefore, I find it to be irrelevant. Furthermore, the requirement that a facility create and implement a policy that is designed to prevent abuse is not contained in 42 C.F.R. § 483.13(c)(1)(i) although the broader language of 42 C.F.R. § 483.13(c) does state such a requirement. I note that, in any event, Petitioner produced a copy of its policy and it is evidence. P. Ex.7; P. Ex. 8. The policy predates the survey and was in effect at the time of the survey.

CMS now asserts, for the first time, that Petitioner failed to prepare incident reports timely about the assaults that Resident # 2 perpetrated against other residents. I find the allegation to be irrelevant inasmuch as Petitioner was not given notice of it prior to the hearing. Moreover, I question whether Petitioner was under any obligation to treat the assaultive behavior by Resident # 2 as "abuse" for the reasons that I have discussed above. I note, however, that Petitioner's staff fully documented the assaultive behavior of Resident # 2. The resident's treatment record is replete with the staff's documentation of the resident's conduct including his assaults on other residents and Petitioner's staff. P. Ex. 1.

The survey report does aver that Petitioner failed to report to the police and to a local anti-abuse hotline episodes of assaults by Resident # 2 against other residents. Petitioner does not deny that allegation. However, that does not establish any basis for me to find that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.13(c)(1)(i). There is no abuse investigation and documentation requirement in this subsection even assuming that resident-against-resident assault constitutes "abuse."

There are reporting and investigation requirements at other parts of the regulation. 42 C.F.R. § 483.13(c)(2), (3), (4). CMS did not allege that Petitioner failed to comply with these requirements. Furthermore, I question whether the investigation and reporting requirements of 42 C.F.R. § 483.13(c)(2), (3), and (4) apply to resident-against-resident assaults inasmuch as the prohibitions against abuse in 42 C.F.R. § 483.13(c)(1)(i) do not apply to such events. But, even if these requirements did apply to such events, they cannot be read to require reporting of an episode of resident-against-resident assault to the police or to an anti-abuse hotline unless such reporting is required by relevant State law. See 42 C.F.R. § 483.13(c)(2),(4). CMS has offered nothing to show that a facility in Florida is required by Florida State law to report a resident-against-resident assault to the police or to a local anti-abuse hotline.

I note that Petitioner's policy concerning abuse specifically provides that resident-against-resident incidents will not be reported. P. Ex. 7, at 1. Petitioner's failure to report Resident # 2's behavior was, therefore, consistent with Petitioner's own policy.

Further, CMS failed to offer any evidence to show that Petitioner or its staff abused residents or used corporal punishment or involuntary seclusion. The allegations in the survey report focus exclusively on the alleged failure by Petitioner to prevent Resident # 2 from assaulting other residents. HCFA Ex. 23, at 5 - 9. However, as I discuss above, neither resident-against-resident assaults nor failure by a facility to prevent such assaults is addressed by 42 C.F.R. § 483.13(c)(1)(i), although such failures are addressed by another regulation, 42 C.F.R. § 483.25(h)(2).

c. Petitioner proved by the preponderance of the evidence that it complied substantially with the drug monitoring requirements of 42 C.F.R. § 483.25(l)(1).

The report of the June 11, 1998 survey alleges, at Tag 329, that Petitioner failed to comply substantially with the drug monitoring requirements of 42 C.F.R. § 483.25(l)(1). HCFA Ex. 23, at 9 - 11. The regulation states the following requirements:

Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used:

(i) In excessive dose (including duplicative drug therapy); or

(ii) For excessive duration; or

(iii) Without adequate monitoring; or

(iv) Without adequate indications for its use; or

(v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or

(vi) Any combinations of the reasons above.

42 C.F.R. § 483.25(l)(1).

The survey report alleges, specifically, that Petitioner failed to provide adequate monitoring to two of its residents in their use of drugs. HCFA Ex. 23, at 10 - 11. These residents are identified in the survey report as Resident # 10 and Resident # 9. Id. Both of these residents were receiving psychoactive medications. Resident # 10 was receiving Mellaril and Resident # 9 was receiving Risperdal. Id. The survey report alleges that Petitioner's staff did not monitor either of these residents adequately because it did not monitor them daily for possible side effects from these medications. Id. Additionally, the survey report alleges that Petitioner's staff did not adequately document the absence of side effects to medications that were given to Residents #s 10 and 9.

An underlying premise of the survey report's allegations is that "adequate monitoring" of the administration of Mellaril and Risperdal necessarily must be daily monitoring of those medications. HCFA Ex. 23, at 10 - 11. There is no explicit requirement in the regulations that a facility monitor its residents' use of medications daily. However, it is possible in a particular instance that daily monitoring might be in order for a particular resident for the administration of a particular drug. Thus, even though there is no explicitly stated requirement in the text of the regulation that monitoring be done daily, there might be a medical basis for doing so in the appropriate case. And, if there is a medical requirement for daily monitoring of drug use then daily monitoring would be "adequate" within the meaning of the regulation. The question is: was daily monitoring of Mellaril and Risperdal medically required here and was it, therefore, "adequate?"

CMS argues that the "industry standard" in nursing homes is to conduct daily monitoring and to make daily written observations of the effect of psychoactive medications, including Mellaril and Risperdal, on residents. CMS's posthearing brief at 26 - 27. As support for this argument, CMS relies on the testimony of Mary Jane Battaglia, one of the surveyors who participated in the June 11, 1998 survey of Petitioner. Tr. at 80 - 81; 85; 90 - 94. She testified that:

As a surveyor, if a person is on a psychoactive medication, especially antipsychotic medications, we do look for daily behavior monitoring qualitatively and quantitatively, the number of episodes that they exhibit, the behavior for which the drug was prescribed to alter, and any significant side effects as stated.

Id. at 85. She testified that the "industry standard" for monitoring of psychoactive medications was to monitor their use and make written observations daily. Id. at 93.

Ms. Battaglia linked this "industry standard" with the need to assure that residents who receive psychoactive medications do not develop adverse side effects, including tardive dyskinesia. Tardive dyskinesia consists of neurological consequences resulting from use of psychoactive medications and includes involuntary muscle movements.

Petitioner countered the testimony of Ms. Battaglia with testimony from its experts, Renuka Siddharthan, M.D., C.M.D., and Dr. Bensimon. Tr. at 133; 152 -154; 183; 192 - 194. These two physicians both testified that they were unaware of any industry-wide requirement that psychoactive medication use by nursing home residents be monitored daily. They observed, moreover, that advice to surveyors published by CMS does not contain such a requirement. In their opinion, monitoring of psychoactive medications less frequently than daily would be adequate, depending on the needs of the individual whose medication use is being monitored. Dr. Bensimon testified that it was certainly not necessary to conduct daily monitoring of the residents in question for the possible side effects of psychoactive medications, including tardive dyskinesia:

It takes several months to develop tardive dyskinesia. They would come in to screen them periodically. Periodically . . . means every six months.

Tr. at 192 - 193.

I find the testimony of Drs. Siddarthan and Bensimon to be more persuasive than that of Ms. Battaglia. Ms. Battaglia has a Master's degree in nursing. She did not testify that she has any specialized training in psychiatric nursing or in the side effects of psychoactive medications. However, both Dr. Siddarthan and Dr. Bensimon are physicians and Dr. Bensimon is board-certified in gerontology. Furthermore, Dr. Bensimon had a treating relationship with both Resident # 10 and Resident # 9 and is the medical professional who is best qualified to know what level of monitoring of medications would be appropriate for these residents.

My conclusion is that, while Residents #s 10 and 9 certainly needed be monitored for their use of psychoactive medications, there was no medical reason to monitor these residents daily. Periodic monitoring in the case of these residents meant monitoring on a less frequent than daily basis. Thus, CMS's argument that Petitioner was required to monitor Residents #s 10 and 9 daily is not supported by the preponderance of the evidence.

A second underlying premise of the June 11, 1998 survey report is that "adequate monitoring" of a resident's drug therapy requires documentation, not only of the presence of any side effects, but of the absence of side effects. CMS argues that the records that Petitioner generated concerning the drug regimes of Residents #s 10 and 9 were deficient because they failed to specifically record that side effects were absent on particular occasions.

I find this argument to be unsupported, both by the language of the regulation, and by evidence establishing acceptable medical practice. 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.

The physicians who treated the residents were not looking for specific forms or marks on forms to advise them of the presence or absence of side effects. They depended on their own observations as well as the information that Petitioner's staff communicated to them through face-to-face communications and in the residents' treatment records. As was made clear from the testimony of Dr. Bensimon, he received adequate information from Petitioner's staff about the effects of medications on the residents. Dr. Bensimon did not need to see a form which documented the absence of side effects in order to know whether the residents were experiencing side effects. He received information about side effects directly from Petitioner's staff. Tr. at 190 - 191.

The Florida State survey agency's report does not allege that Petitioner failed in general to monitor Residents #s 10 and 9 for the effects of the medications that these residents were taking. As I have discussed above, the survey report focuses on Petitioner's staff's alleged failure to: monitor residents daily and to record the absence of side effects of medications.

But, in any event, the record plainly establishes that Residents #s 10 and 9 were monitored for the effects of the drugs that they were taking. Petitioner's staff monitored Resident # 10 daily for the effects of Mellaril. Tr. at 105 - 106, 111. The resident's care plan directed Petitioner's staff to monitor the resident. P. Ex. 3 at 92. Resident # 10 was examined by physicians, including Dr. Bensimon, on seven different occasions between April 23, and June 15, 1998 and no side effects of Mellaril were observed by these physicians on any of these occasions. Id. at 7 - 14.

Petitioner monitored Resident # 9 adequately for the effects of Risperdal. Tr. at 116 - 117; 157. The resident's care plan, which was completed on April 23, 1998, sets forth as an objective the minimization of signs of tardive dyskinesia. P. Ex. 2, at 40. Petitioner's staff recorded the resident's response to Risperdal monthly between January and May, 1998. Id. at 55; Tr. at 155. The resident's treating physician, Dr. Bensimon, was aware that the resident had manifested some signs of tardive dyskinesia. Tr. at 156. He managed the resident's care by altering the dosage of Risperdal that the resident was receiving and by prescribing additional medication to control tardive dyskinesia. Id. at 156 - 157.

3. There is no basis to impose the remedy of denial of payment for new Medicare admissions against Petitioner during the period which ran from August 18 through August 31, 1998 inasmuch as Petitioner did not fail to comply substantially with participation requirements during this period.

As I discuss above, at Finding 1, a basis would exist to deny payment to Petitioner for new Medicare admissions during the period which ran from August 18, 1998 through August 31, 1998 if Petitioner failed to comply substantially with even one Medicare participation requirement during that period. But, the converse also is true. There is no basis to impose the remedy if Petitioner was complying substantially with participation requirements during the August 18 - 31, 1998 period.

III. Conclusion

There is no basis to deny payment for new Medicare admissions to Petitioner during the August 18 - 31, 1998 period. The record fails to demonstrate that Petitioner was not complying substantially with any participation requirement during the August 18 - 31, 1998 period.

JUDGE
...TO TOP

Steven T. Kessel

Administrative Law Judge

 

CASE | DECISION | JUDGE