Medford Care Center, DAB CR6094 (2022)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties against Petitioner, Medford Care Center (Petitioner or Medford), a skilled nursing facility, of $505 per day for each day of a period that began on March 3, 2017, and that continued through May 5, 2017.

I.  Background

This case has a complicated history.  It was first assigned to me on September 29, 2017.  At that time, it comprised allegations by CMS that Petitioner had failed in several respects to comply substantially with Medicare participation requirements, including noncompliance that put residents of Petitioner's facility at immediate jeopardy.  On March 30, 2018, I issued a decision granting summary judgment in favor of CMS on all issues.  Medford Care Center, DAB CR5660 (2018).  Petitioner appealed my decision to the Department Appeals Board (Board).  After a lapse of more than three years, on May 24, 2021, an appellate panel of the Board remanded the case to me, finding that there were disputed issues of fact.  Medford Care Center, DAB No. 3040 (2021).

I scheduled a hearing for November 8, 2021.  The parties requested that the hearing be postponed, advising me that they were negotiating a settlement.  I granted their request.

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Subsequently, the parties advised me that they had settled all issues except that they continued to disagree about whether Petitioner had failed to comply substantially with the requirements of 42 C.F.R. §§ 483.24 and 483.25(k)(1) and whether the remedy that CMS determined to impose for that alleged noncompliance was reasonable.

I rescheduled the hearing and conducted an in-person hearing by TEAMS teleconference on March 17, 2022.  At the hearing I received into evidence exhibits from CMS identified as CMS Ex. 1-3, CMS Ex. 7, CMS Ex. 9, CMS Ex. 16, CMS Ex. 18-20, and CMS Ex. 22.  I received into evidence an exhibit from Petitioner identified as P. Ex. 2.  I heard the cross-examination testimony of one witness, Ms. Christine Farfalla.  Her direct testimony is in evidence as CMS Ex. 20.

II.  Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues now before me are whether Petitioner failed to comply substantially with a Medicare participation requirement and whether CMS's remedy determination is reasonable.

B. Findings of Fact and Conclusions of Law

A skilled nursing facility must provide the necessary care and services to each resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being consistent with that resident's comprehensive assessment and plan of care.  42 C.F.R. § 483.24.  It must provide pain management to each resident that is consistent with professional standards of practice.  42 C.F.R. § 483.25(k).  CMS asserts that Petitioner failed to comply substantially with these requirements in providing care to a resident who is identified as Resident # 15.

The gravamen of CMS's allegations is that Petitioner's staff, a licensed professional nurse, failed to take necessary precautions to prevent Resident # 15 from experiencing pain during treatment of a wound, and failed, additionally, to respond to signs that the resident was experiencing pain during that treatment.  More specifically, CMS alleges that the nurse failed to administer pain medication – Tylenol # 3 – to the resident one hour prior to treatment as prescribed, failed to document the administration of that medication, and failed to cease treating the resident when the resident manifested pain.1

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The evidence, consisting of Resident # 15's treatment records, additional documents, and Ms. Farfalla's credible testimony, amply supports CMS's allegations.  CMS Ex. 19; CMS Ex. 20; Transcript at 5-23.

Petitioner had a pain management policy that instructed its staff to assess residents for pain and to develop plans of care for each resident that "will achieve pain relief and comfort in accordance with the resident's needs and goals."  CMS Ex. 7 at 1.  The policy required staff to assess each resident daily and to take appropriate interventions to address each resident's pain on each nursing shift.  Id.

The pain management policy required staff to assess non-verbal signs of pain as well as verbal complaints.  CMS Ex. 7 at 1; see CMS Ex. 18 at 9.  That was important in the case of Resident # 15, because the resident, a demented individual, was not capable of meaningful verbal communication.  CMS Ex. 19 at 67-71; CMS Ex. 20 at ¶ 24.  That did not mean that the resident was incapable of expressing pain.  CMS Ex. 18; CMS Ex. 20 at ¶ 23.  Non-verbal pain behaviors can include facial expressions such as frowning, grimacing, distorted expression, and rapid blinking.  Id.  Such behaviors can also include body movements such as rigidity, tension, guarding, fidgeting, mobility changes, and motor restlessness.  Id.

Petitioner's policies also include the administration of medication.  CMS Ex. 1 at 42-43.  Among other things, this policy required staff to administer medication pursuant to the prescribing physician's orders and to document every administration of medication.  Id.; CMS Ex. 20 at ¶ 17.2

Resident # 15 suffered from a skin tear on her knee.  CMS Ex. 19 at 59-60.  A physician prescribed daily treatment of the wound, including applying fresh dressings and antibiotic ointment.  Id.  Resident 15's physician also prescribed Tylenol # 3 to be administered to the resident one hour prior to each treatment.  Id. at 2, 24.

On March 2, 2017, at about 9:50 a.m., surveyors observed the licensed professional nurse administering treatment to Resident # 15.  CMS Ex. 20 at ¶ 28.  The nurse removed the gauze covering the resident's wound and threw it away.  Id.  Some gauze continued to

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adhere to the resident's knee.  Id.  The nurse removed the adhering gauze by applying saline solution to it and pulling it away from the resident's knee.  Id.  The resident grimaced and moved her leg away from the nurse while the nurse was performing this procedure.  Id.  At one point the nurse stopped for about three seconds, but then continued removing the adhering gauze.  Id.  The surveyors observed that the resident's skin tear was bleeding during this procedure.  Id.

Petitioner's controlled medication utilization record states that the resident was administered Tylenol # 3 at 10 a.m. on March 2, 2017.  CMS Ex. 19 at 23.  However, at that time, surveyors were observing the resident receiving treatment for her wound, and no medication was administered to the resident.  CMS Ex. 20 at ¶ 30.  This record, therefore, is clearly incorrect.  The medication administration record for Resident # 15, a document that is distinct from the controlled medication utilization record, was not initialed on March 2, 2017 to document that the resident received Tylenol # 3.  Id. at 24; CMS Ex. 20 at ¶ 30.

When queried by surveyors, the licensed professional nurse admitted that Resident # 15 had not received pain medication one hour before the March 2 treatment of her wound and was unable to state when it had been administered.  CMS Ex. 20 at ¶ 30.

The treatment of Resident # 15 by Petitioner's staff failed in two respects to comply with Medicare participation requirements.  First, the nurse who treated the resident failed to respond appropriately to the resident's nonverbal expressions of pain; not only in violation of regulatory requirements, but in violation of Petitioner's own pain management policy.  The nurse should have known that the resident was in pain when she grimaced and moved her leg away as the nurse removed adhering gauze.  At the least, that behavior should have caused the nurse to stop her treatment, assess the resident, and come up with an alternative plan to treat her.3   Instead, the nurse continued the treatment despite the resident's nonverbal protestations.

Second, Petitioner's staff failed to document administration of pain medication to Resident # 15, as was required by Petitioner's own policy and consistent with regulatory requirements.  Moreover, the resident did not receive pain medication timely on March 2, 2017.  Indeed, I infer that she did not receive the prescribed medication on that date, since the resident's treatment records do not document administration of Tylenol # 3 and the treating nurse was unable to recall when she had given the medication to the resident.

The presence of actual injury or harm is not a necessary element of a finding of failure to comply substantially with a Medicare participation requirement.  A failure by a skilled

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nursing facility to comply with regulatory requirements is substantial and may be the basis for imposition of remedies if that failure poses the potential for causing more than minimal harm or injury to one or more residents.  See 42 C.F.R. § 488.301.

Here, the evidence plainly establishes that Petitioner's noncompliance posed a potential for more than minimal harm to Resident # 15.  First, Petitioner's staff disregarded not only Petitioner's policy, but the nonverbal signs of pain evinced by the resident.  The evidence establishes that a nurse continued treating the resident even though the resident was in apparent pain.  Second, the failure to timely administer prescribed pain-relieving medication to the resident put the resident at risk for pain and discomfort.

Although I do not find it necessary to find actual harm to Resident # 15 to sustain CMS's noncompliance allegations, I find that actual harm occurred here.  Resident # 15 was in evident pain – pain that was made more likely by the nurse's failure to comply with a physician's order to administer pain medication and by her failure to respond appropriately to the resident's nonverbal complaints.

I find the civil money penalties that CMS determined to impose to be reasonable.  A penalty of $505 for each day of Petitioner's noncompliance constitutes a small fraction of the maximum daily penalty amount that may be imposed for noncompliance that does not reach the level of immediate jeopardy.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3.4

The seriousness of Petitioner's noncompliance justifies the penalty amount.  42 C.F.R. §§ 488.438(f)(3), 488.404.  Here, the noncompliance, at the least, put Resident # 15 at risk for suffering unnecessary pain.

I find Petitioner's arguments to be without merit.

Petitioner does not rebut the evidence on which I rely.  Effectively, it concedes that its nurse failed to treat Resident # 15 appropriately, that she failed to administer pain medication to the resident pursuant to a physician's order and to document properly the administration of medication to the resident.

Petitioner argues, however, that there is no basis for a finding of noncompliance because there is no proof that Resident # 15 was harmed by the staff's deficient care.  Asserting that the mistreatment of Resident # 15 was an isolated incident, Petitioner contends that: "Any minor discomfort to the patient surely did not rise to the level of actual harm."  Petitioner's brief at 4 (emphasis in original).

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As I have explained, actual harm is not a necessary element of a finding of failure to comply substantially with participation requirements.  All that is required is for a deficiency to have the potential for causing a resident to experience more than minimal harm.  See 42 C.F.R. § 488.301.  That said, there is persuasive evidence in this case that the resident was, in fact, harmed by the staff's deficient care.  The resident showed signs of being in actual pain and, moreover, was deprived of the benefit of pain medication that her physician had prescribed.

Principally, Petitioner attacks the civil money penalties that CMS imposed by asserting that the penalties were imposed retroactively and, consequently, unfairly.  Petitioner's brief at 6-7.  Petitioner asserts that on March 2, 2017, CMS first broached the issue of the care given to Resident # 15 but did not impose a remedy until April 16, 2017.  Id.  That, according to Petitioner, is an unlawful "retroactive" penalty.  Id.

However, Petitioner identifies no law or regulation that bars CMS from imposing a remedy for continuing noncompliance that predates the date of the penalty notice.  Petitioner's brief at 6-7.  There is, in fact, nothing in the regulations that prohibits CMS from doing so.  Furthermore, Petitioner concedes that it had actual notice, beginning on March 2, 2017 – the date that CMS first began imposing remedies – that CMS had found deficiencies, including the deficiency that is at issue here.  Petitioner's brief at 6.  Petitioner thus knew that a remedy determination could be forthcoming as of March 2, 2017.

Petitioner did not offer proof that it corrected its noncompliance on any date prior to May 5, 2017, the date on which CMS determined that Petitioner had corrected its deficiency.  Petitioner's brief.

Here, Petitioner has not offered anything other than its plan of correction to establish when it attained compliance.  It asserts that the deficient care provided to Resident # 2 was an isolated incident, thereby suggesting that Petitioner needed to implement no remedial action other than addressing that specific incident.  Petitioner's brief at 6-7.  But that is not proof that rebuts CMS's duration findings.

Correcting noncompliance means not only that the facility corrected the specific cited instances of deficiency, but also that it implemented a plan of correction designed to assure that no future incidents would occur.  A facility remains noncompliant until it affirmatively demonstrates that it has achieved substantial compliance once again.  Life Care Ctr. of Elizabethton, DAB No. 2367 at 16-17 (2011); Premier Living and Rehab. Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care, DAB 1658 at 12-15 (1998).  The burden is on the facility to prove that it has resumed complying with program requirements, not on CMS to prove that deficiencies continued to exist after they were discovered.  Asbury Center at Johnson City, DAB No. 1815 at 1920 (2002).  A facility's

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return to substantial compliance usually must be established through a resurvey.  42 C.F.R. § 488.454(a).

The plan of correction submitted by Petitioner represented that it would take multiple steps to correct its deficient performance.  CMS Ex. 2 at 26-27.  First, Petitioner asserted that it had terminated the employment of the nurse who provided care to Resident # 15.  Id.  Second, Petitioner asserted that it would provide in-service training to its staff to assure that the staff understood their responsibilities.  Id.  Third, it represented that its management would perform weekly reviews to assure that compliance was occurring.  Id.

The second and third measures could not have been implemented instantly and would have taken time.  It is Petitioner's obligation to prove exactly when those measures were implemented.  It has offered no evidence to derogate from CMS's findings.

Finally, Petitioner asserts that the total amount of civil money penalties that CMS imposed – more than $30,000 – is excessive and a significant hardship on Petitioner.  Petitioner's brief at 6.  As support for this assertion Petitioner offers the declaration of its administrator, Mark Stratoti, in which he states without corroborating evidence that "the CMP imposes a significant hardship on [Petitioner]."  P. Ex. 2 at 3.

A skilled nursing facility's financial condition is one criterion that may be used in deciding the reasonableness of a civil money penalty.  42 C.F.R. § 488.438(f)(2).  But it is not CMS's burden to prove that a facility can pay a penalty amount without sustaining hardship.  To the contrary, the burden of proving a lack of wherewithal to pay a penalty falls entirely on the facility.  Heritage Plaza, DAB No. 2829 at 22 (2017).

Here, Petitioner has offered no evidence to support Mr. Stratoti's claim.  Petitioner's brief; P. Ex. 2.  It has not offered a certified statement of its financial condition, it has not offered evidence of its assets and liabilities, nor has it offered evidence showing how its day-to-day operations would be affected by the penalty amount.  I find Petitioner's hardship assertion to be unsupported and therefore, no basis to mitigate the penalty amount.

1. In its brief, Petitioner refers to the medication as "Tylenol."  Petitioner's Post-hearing Brief (Petitioner's brief) at 1.  I take notice that Tylenol # 3 is not an over-the-counter medication, but rather, combines Acetaminophen with Codeine, a controlled substance.  It is an opiate medication that is available by prescription only.  The medication is administered to relieve mild-to-moderate pain.  https://www.mayoclinic.org/drugs-supplements/acetaminophen-and-codeine-oral-route/description/drg-20074117 (last visited May 31, 2022).
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2. I cite here to the Statement of Deficiencies that summarizes Petitioner's medication administration policy and to Ms. Farfalla's testimony.  The policy itself is contained in an exhibit that CMS did not offer at the hearing, CMS Ex. 6.  This certainly was an inadvertent failure by CMS to offer the exhibit.  In any event, I find no material difference between the summary in the Statement of Deficiencies, Ms. Farfalla's testimony, and the text of the exhibit.
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3. Ms. Farfalla interviewed Petitioner's director of nursing, who stated that a nurse should cease treating a resident if the resident evinces signs of pain.  CMS Ex. 20 at ¶ 32.
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4. Maximum penalty amounts are adjusted annually to account for inflation.  Here, I refer to the maximum non-immediate jeopardy amount that was applicable in 2017, which is $6,289.
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