Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Medford Care Center
Centers for Medicare & Medicaid Services.
Docket No. C-17-1220
Decision No. CR5060
I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS), sustaining its determination that Petitioner, Medford Care Center, a skilled nursing facility, failed to comply substantially with Medicare participation requirements at a level of noncompliance that placed residents of Petitioner’s facility at immediate jeopardy. I sustain the imposition of the following civil money penalties against Petitioner:
- A penalty of $8999 for each day of a period that began on March 1, 2017, and continued through March 2, 2017; and
- A penalty of $505 for each day of a period that began on March 3, 2017, and continued through May 4, 2017.
CMS moved for summary judgment. With its motion, it filed exhibits identified as CMS Ex. 1-CMS Ex. 22. Petitioner opposed the motion and filed exhibits identified as P. Ex. 1-P. Ex. 5. It also objected to my receiving some of CMS’s exhibits.
It is unnecessary that I rule as to the admissibility of exhibits inasmuch as I find no disputed material facts. I do not receive the parties’ exhibits into the record. I cite to some of them, but only to illustrate facts that are not in dispute.
II. Issues, Findings of Fact and Conclusions of Law
The issues in this case are whether the undisputed material facts establish that Petitioner failed to comply substantially with Medicare participation requirements, whether those facts sustain CMS’s determination of immediate jeopardy, and whether the undisputed material facts establish CMS’s remedy determinations to be reasonable.
B. Findings of Fact and Conclusions of Law
CMS asserts that Petitioner failed to comply substantially, at the immediate jeopardy level of noncompliance, with three Medicare participation requirements.1 These requirements are stated at the following regulations, in effect in March, 2017: 42 C.F.R. §§ 483.10(g)(14); 483.21(b)(3)(i); and 483.45(f)(2).2 These regulations require, respectively, a skilled nursing facility to: consult with a resident’s treating physician when there is a need to alter a resident’s treatment significantly; provide or arrange services, as is outlined by a resident’s comprehensive care plan, that meet professional standards of quality; and ensure that residents are free of any significant medication errors.
The undisputed facts of this case plainly establish that Petitioner failed to comply with these requirements. Each material fact centers on the care that Petitioner’s staff gave to a single resident, identified as Resident # 14. The resident is a recipient of a kidney transplant. He is prescribed Prograf (a/k/a Tacrolimus), a medication that functions as an immunosuppressant. CMS Ex. 1 at 1-16; CMS Ex. 13 at 2. Prograf is administered to transplant recipients so that their immune systems do not reject transplanted organs. CMS Ex. 4; CMS Ex. 5.
Resident # 14’s physician ordered that the resident be given Prograf orally twice a day. CMS Ex. 13 at 2. However, there is no dispute that Petitioner’s staff failed to administer the medication to the resident on the evening of March 1 and on the morning of March 2, 2017, in contravention of the physician’s order. CMS Ex. 11 at 1; CMS Ex. 17 at 5. Staff failed to provide the medication to Resident # 14 because the supplying pharmacy had run out of it. CMS Ex. 1 at 1-6; CMS Ex. 17 at 5.
The pharmacy advised Petitioner’s staff on February 27, 2017, that it was out of Prograf and that an additional supply of the medication would not be delivered to Petitioner until March 2, 2017. CMS Ex. 1 at 1-6. Petitioner’s staff therefore knew as early as February 27, 2017, that there would be a shortfall of Prograf and that Resident # 14 might not receive the medication at some point. There are no facts to suggest that the staff attempted to ameliorate this situation. Petitioner’s staff did not call the pharmacy prior to March 2, 2017. Petitioner’s staff did not notify Petitioner’s nursing supervisor of the failure to provide Prograf to the resident. Nor did it consult with Resident # 14’s treating physician, either prior to March 1, or on March 1 or 2, concerning the failure to provide the resident with his medication. CMS Ex. 16 at 11; CMS Ex. 17 at 6; CMS Ex. 20 at ¶ 14; CMS Ex. 21 at ¶ 17.
Petitioner has policies governing administration of medication to residents and the undisputed facts establish that Petitioner’s staff violated these policies. Petitioner’s “Medication Procurement” policy states that if medication is not available the staff will consult with Petitioner’s nursing supervisor and with an affected resident’s treating physician in order to find a replacement medication. CMS Ex. 6 at 3. If a replacement cannot be found Petitioner’s staff must contact the facility’s medical director. Id. Petitioner also has a “Medication and Treatment Record Administration” policy that, among other things, directs Petitioner’s nursing staff to become knowledgeable in the specific attributes of medications being administered to residents. Id. at 1-2. Medication must be administered according to specific times on the medication’s protocol unless the resident’s treating physician orders otherwise. Id.
Governing regulations and Petitioner’s own policies made it imperative that Petitioner’s staff took the following measures to address the inability to administer Prograf to Resident # 14:
- The staff should have immediately consulted with Resident # 14’s treating physician on February 27, 2017, concerning the anticipated shortfall of Prograf and should have consulted with him again on March 1 and 2 when the medication became unavailable. Such discussions should have gone beyond mere “notification.” A facility staff is required to “consult” with a treating physician when there is a significant change affecting a resident’s condition. 42 C.F.R. § 483.10(g)(14). In this case, consultation would have required notification of the problem as well as a discussion as to the lack of medication’s potential significance and the possibility of alternative treatment. Petitioner’s staff did none of that.
- On March 1 and 2, 2017, when Prograf was unavailable, the staff should have notified Petitioner’s nursing supervisor of the issue. The staff failed to do that.
- Staff should have been aware of the potential issues arising from failure to administer Prograf to Resident # 14 pursuant to his physician’s orders. The only reasonable inference that I can draw from the staff’s passivity despite the missing medication is that the staff was uneducated as to the purpose of the medication and the possible downside of not administering it as prescribed.
Petitioner’s argument in opposition to CMS’s motion is that Resident # 14 suffered no harm as a consequence of the failure to administer Prograf to him. To support this contention, Petitioner relies on statements by a physician expert and by the resident’s treating physician. P. Ex. 1; P. Ex. 2 at 11-12. They opine that Resident # 14 was medically stable and that there was no potential of harm to the resident from missing two consecutive doses of Prograf.
I do not find that these statements raise any dispute as to the material facts of this case. The issue here is not whether Resident # 14 was actually harmed by the failure to administer Prograf to him. Rather, the issue is the likelihood of serious injury, harm, or death to residents of Petitioner’s facility resulting from Petitioner’s staff’s disregard of policies and governing regulations.
Petitioner’s staff had no way of knowing that failure to administer Prograf to Resident # 14 would not have adverse consequences. There are absolutely no facts from which I might infer that the staff made an informed judgment that the resident could do without two consecutive doses of the medication. The staff knew only that the resident’s treating physician had ordered that the medication be administered to the resident twice a day and that he would miss two consecutive doses of it. That knowledge made it imperative that the staff consult with the resident’s physician in order to determine whether the Resident might be harmed and to determine also whether there were alternative treatment regimens that might be employed. Similarly, the staff should never have simply accepted on its
face the pharmacy’s notification that Prograf would not be supplied for two days. That knowledge triggered not only a duty to consult but also a responsibility to determine whether there were alternative sources of the medication available.
Furthermore, the failure by Petitioner’s staff to comply with Petitioner’s policies and regulatory requirements in this case evidences a generalized incomprehension by the staff about what its duties are in circumstances like this. The only reasonable inference that I can draw from the failure to consult with the physician and to seek out alternative medication sources in the case of Resident # 14 is that the staff was not sensitized, either to its duties and responsibilities, or to the potential harm that might be caused by not delivering medication without consultation with the prescribing physician. In other words, Resident # 14 was not the only vulnerable resident at Petitioner’s facility. Potentially, any resident similarly situated would be in peril.
Petitioner’s argument about the absence of provable harm to Resident # 14 is the kind of “no harm, no foul” argument that skilled nursing facilities often make when they are found to be deficient in providing care. But, the absence of actual harm does not excuse a facility’s noncompliance. In any case, noncompliance is measured by the likelihood of harm – not just in the instance that is the basis of the noncompliance citation, but also in terms of the likelihood of harm to all residents who are similarly vulnerable.
The undisputed material facts plainly support CMS’s determination of immediate jeopardy level noncompliance. I cannot infer from these facts anything less than that. “Immediate jeopardy” is defined as the likelihood of serious injury, harm, or death to a resident resulting from a facility’s noncompliance. 42 C.F.R. § 488.301. The likelihood that residents of Petitioner’s facility would be seriously harmed or suffer worse consequences from the staff’s indifference to regulatory requirements and Petitioner’s own policies was overwhelming. In this case, the staff blatantly disregarded the treating physician’s orders and failed to consult with the physician after having done so. That is a recipe for disaster with elderly, frail, sick, and dependent residents.
I find CMS’s remedy determinations to be reasonable. The immediate jeopardy level penalties of $8999 per day for each day of a two-day period (March 1 and 2, 2017) fall easily within the range of permissible immediate jeopardy level penalties. 42 C.F.R. § 488.438(a)(1)(i). They are, in fact, quite modest given the seriousness of Petitioner’s noncompliance. The non-immediate jeopardy level penalties of $505 per day for each day of the period that ran from March 3 through May 4, 2017, are at the low end of permissible non-immediate jeopardy level penalty amounts. 42 C.F.R. § 488.438(a)(1)(ii).
Nor is there a dispute about the facts relating to duration of Petitioner’s noncompliance. The finding that immediate jeopardy persisted at Petitioner’s facility on March 1 and 2, 2017, is fully supported by the undisputed facts establishing Petitioner’s noncompliance.
CMS determined to continue low-level penalties against Petitioner until Petitioner retrained its staff in compliance with Petitioner’s policies and with regulatory requirements. That retraining was not completed until May 5, 2017. Petitioner argues that it would have completed retraining sooner had it known that CMS would have cited it for noncompliance. That assertion does not gainsay the fact that Petitioner remained out of compliance until retraining was complete.
Steven T. Kessel Administrative Law Judge
1. CMS also alleges that Petitioner failed to comply substantially with a fourth Medicare participation requirement, albeit at a level of noncompliance that does not amount to immediate jeopardy. I find it unnecessary to address this fourth allegation of noncompliance inasmuch as the immediate jeopardy level findings amply justify the remedies that CMS determined to impose in this case.
- back to note 1 2. See 81 Fed. Reg. 68688, 68849 (October 4, 2016). In its pre-hearing brief and motion for summary judgment (CMS brief) CMS consistently miscites the regulation as “42 C.F.R. § 483.451(f)(2).” See, e.g., CMS brief at 12. However, it correctly states the regulation’s contents and I do not find the error to be materially misleading.
- back to note 2