SUBJECT:

Sanctuary at Whispering Meadows,

Petitioner,

Centers for Medicare & Medicaid ⁽¹⁾

DECISION

Petitioner, Sanctuary at Whispering Meadows (hereafter "Petitioner" or "facility") is a nursing facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS's) determination, based on a complaint survey completed on October 26, 1999, that Petitioner was not in substantial compliance with Medicare requirements and that its deficiencies caused actual harm to a resident. CMS imposed a per instance civil money penalty (CMP) of $2,800. For the reasons set forth below, I conclude that the facility was out of compliance with the program participation requirements for Quality of Care. I further conclude that the amount of the per instance CMP is reasonable.

BACKGROUND

On October 26, 1999, Lesley Davis, R.N., a surveyor employed by the Ohio Department of Health (State Agency), performed a complaint survey at the facility. During the survey, she personally observed facility staff providing skin care to a patient, George B. ⁽²⁾At this time, she observed nine pressure sores on his feet and heels. George B. had been admitted to the facility without pressure sores, but developed them after he was prescribed psychoactive drugs that decreased his mobility. Ms. Davis completed the complaint survey (which did not concern George B. or pressure sores). Transcript (Tr.) 28. However, based on her initial observation of George B., Ms. Davis and another surveyor were instructed to return to the facility on November 3, 1999, to perform an extended survey relating to pressure sores. In the course of the extended survey, Ms. Davis concluded that George B.'s pressure sores were not unavoidable. Based on her observations, the State Agency found Petitioner out of compliance with the requirement for Quality of Care, 42 C.F.R. § 483.25(c) (Tag F-314). The State Agency notified Petitioner and CMS of its findings in a Statement of Deficiencies (Form 2567) forwarded to Petitioner by letter dated November 12, 1999. CMS Exhibit (Ex.) 2.

By letter dated December 3, 1999, CMS advised Petitioner that CMS was imposing a per instance CMP of $2,800 based on the noncompliance found at the October 26, 1999 survey. CMS Ex. 6. CMS also stated it would impose a denial of payment for new admissions (DPNA), effective November 8, 2000, if the facility failed to achieve substantial compliance with program requirements by that date. ⁽³⁾ Id. The facility responded with a plan of correction dated November 22, 1999. CMS Ex. 5.

Petitioner timely requested a hearing to challenge CMS's determination of noncompliance, and the case was assigned to me for a hearing and decision. I held an in-person hearing in Dayton, Ohio. At the hearing I admitted into evidence Petitioner's Exhibits (P. Exs.) 1-4 and CMS Exs. 1-3, 5, 6, and 9-25 . The parties submitted post-hearing briefs and replies. I base my decision on the testimony, the documentary evidence and the parties' submissions.

ISSUES

1. Whether the facility was out of substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.25(c) (Quality of Care).

2. If the facility was not in substantial compliance, whether the $2,800 per instance CMP imposed is reasonable.

STATUTORY AND REGULATORY BACKGROUND

The Social Security Act ("Act") sets forth requirements for skilled nursing facility and nursing facility ("nursing facility") participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. § 488.301.

Under the "quality of care" requirement, each resident must receive and a facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. 42 C.F.R. § 483.25. Specifically, a facility must ensure that:

1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and

2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

42 C.F.R. § 483.25(c).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include imposing a CMP. See Act, section 1819(h). CMS may impose a CMP for each instance that the facility is not in substantial compliance with program requirements. 42 C.F.R. § 488.430(a). When CMS imposes a CMP for an instance of noncompliance, the penalties range from $1,000 to $10,000 per instance. 42 C.F.R. § 488.438(a)(2).

In setting the amount of the CMP, CMS considers: 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors found at 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general, specifically with reference to the cited deficiencies.

DISCUSSION

In reviewing CMS's determinations here, I must answer two questions:

1) Was the facility in substantial compliance with the cited regulatory provision? CMS must present a prima facie case with evidence that, if credible and unrebutted, would constitute proof that the facility was not in substantial compliance. The facility then has the ultimate burden of showing, by a preponderance of the evidence, its substantial compliance with the cited provision. Emerald Oaks, DAB No. 1800, at 4 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); Koester Pavilion, DAB No. 1750, at 7-8 (2000).

2) If I conclude that the facility was not in substantial compliance, I next consider whether the $2,800 per instance CMP imposed is reasonable, taking into consideration the factors enumerated in 42 C.F.R. § 488.438(f). If I conclude that the facility was not in substantial compliance, I may not review CMS's exercise of discretion in deciding to impose a per instance CMP; nor may I reduce the per instance CMP to zero. 42 C.F.R. § 488.438(e).

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

1. Petitioner was not in substantial compliance with the program participation requirement found at 42 C.F.R. § 483.25(c) (Quality of Care).

In order to meet the overall quality of care requirement that it provide what is necessary for each resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, the facility must ensure that residents do not develop pressure sores unless they suffer from a clinical condition which makes the development of pressure sores unavoidable. 42 C.F.R. § 483.25(c). To establish a prima facie case of noncompliance with 42 C.F.R. § 483.25(c), CMS must show that a resident who entered a facility free of pressure sores developed them while at the facility. If CMS establishes a prima facie case, the burden is on the facility to prove that the pressure sores were unavoidable. ⁽⁴⁾

George B. (the resident is also referred to as "R2" in CMS Ex. 1), an 82-year-old man, was admitted to the facility on December 2, 1998. CMS Ex. 9, at 2; CMS Ex. 18. His diagnoses included dementia, congestive heart failure, arteriosclerotic heart disease, atrial fibrillation, vertigo, vitamin B12 deficiency, and Parkinsonism. CMS Ex. 18. At the time he was admitted to the facility, George B. was free of pressure sores. CMS Ex. 9, at 2; Tr. 48-49.

In a care plan dated June 3, 1999, Petitioner assessed George B. as at risk for the development of pressure sores due to his inability to ambulate and incontinence. CMS Ex. 15. The care plan called for the following approaches to avoid skin breakdown:

1. assess skin condition daily + report weekly;

2. change +/or check [incontinence briefs] Q2 [every two hours];

3. pericare [with] incontinence;

4. turn and reposition Q2 [every two hours];

5. monitor dietary intake.

Id.

In another care plan document, also dated June 3, 1999, Petitioner instituted a care plan to deal with combative behavior by George B. CMS Ex. 14. The care plan included the use of two psychoactive drugs, Depakote and Zyprexa. Id. These drugs are both known to have a sedative effect. Tr. 76. On August 7 and August 9, 1999, the care plan was modified to include two additional psychoactive drugs, Trazodone and Risperdal. CMS Ex. 14. According to the Physician's Desk Reference, both Trazodone and Risperdal may cause drowsiness. CMS Exs. 24, at 2; 25, at 2.

On August 8, 1999, a nurse's note records that George B. was very lethargic. CMS Ex. 12, at 11. That same day, a nurse first noted a problem with George B.'s skin. The note stated that his left hip was "very red." Id. On August 9, 1999, George B.'s family expressed concern to Petitioner's staff about George B.'s increased lethargy. Id. The nurses' notes document that George B. experienced periods of lethargy on a number of occasions throughout August. Id. at 11-13. A decreased level of consciousness would increase the resident's risk of developing pressure sores, because the resident would be less able to reposition himself or to voice to care-givers if he was experiencing discomfort. Tr. 36-37.

The facility documented that, on August 12, 1999, George B. had developed three pressure sores, one on the right buttock, one on the left ankle and outer foot, and one on the left heel. CMS Ex. 19, at 1. On August 31, 1999, George B. had six pressure sores (id.); by September 13, 1999, George B. had developed 12 pressure sores on his feet, heels, and ankles. Id. at 2-3. On September 21, 1999, the facility documented that George B. had 11 pressure sores. Id. at 3.

On August 30, 1999, Petitioner ordered Heelbo lifters for George B. CMS Ex. 16, at 4; P. Ex. 1, at 69. There is no record that these devices were supplied to the resident. On August 31, 1999, George B.'s treating physician ordered that he be turned and repositioned hourly and that his feet be kept elevated at all times. CMS Ex. 16, at 5. No changes were made to George B.'s care plan to reflect the use of Heelbo lifters or to indicate that he should be turned and repositioned more frequently that every two hours. See CMS Ex. 15. In fact, there is no record that Petitioner ever revised George B.'s care plan for pressure sore prevention after June 3, 1999. Id. On September 14, 1999, the facility supplied an air mattress to George B. CMS Ex. 16, at 9. On October 4, 1999, the facility obtained a wound care consultation for him. CMS Ex. 5, at 6; P. Ex. 1, at 110.

When Ms. Davis observed George B. during the survey on October 26, 1999, he was in bed, lying on his back. Tr. 38. His feet were pressed against the footboard of the bed, and his heels were resting on the mattress. Tr. 38, 40. The mattress was a circulating air mattress, which is used as a pressure-relieving device. Tr. 38-39. Ms. Davis did not observe any Heelbo lifters in use for George B. Tr. 40. Pillows were placed under his calves, but his feet and heels were not elevated off the bed. Id. George B.'s feet and ankles had dressings on them; his legs were wrapped with gauze and tape up to mid-calf. Tr. 38. Ms. Davis observed some drainage around the outside and inner sides of the foot dressings. Id. When George B.'s care-givers removed the dressings from his feet, Ms. Davis observed approximately nine open pressure areas, with black, necrotic tissue. Tr. 43-44. Ms. Davis charted her observations, including the approximate location of George B.'s pressure sores on a surveyor notes worksheet, which she filled out while she was at the facility on October 26. Tr. 45. See CMS Ex. 9.

Ms. Davis returned to the facility on November 3, 1999, with another surveyor, to conduct an extended survey. Tr. 55. At that time, George B. was not in the facility. Tr. 57. On November 2, 1999, George B. had been admitted to the hospital. CMS Ex. 22, at 1. The surgeon diagnosed gangrene of the right foot and performed an above-the-knee amputation of George B.'s right leg on November 3, 1999. Id.

Petitioner argues that George B.'s pressure sores were unavoidable. It contends that George B. suffered from venous insufficiency and congestive heart failure. P. Br. 3-5. Petitioner cites a medical text for the proposition that these diagnoses may predispose a patient to developing pressure sores. Id. at 4. Petitioner's position seems to be that if a resident diagnosed with these conditions develops pressure sores, the pressure sores are unavoidable. Taken to its logical extension, Petitioner's argument would mean that a facility could never be held to be out of compliance with the regulation, regardless of the care and treatment it provided, as long as the resident suffered from a diagnosis associated with the development of pressure sores. This argument is not supportable under the regulatory scheme governing long-term care facilities' duties to prevent and treat pressure sores.

In the preamble to the regulation establishing this requirement, CMS stressed that it intended to hold facilities liable for poor resident outcomes:

[W]e do not believe it is unreasonable to make the facility responsible for ensuring that basic treatment and services are provided since this is the reason for the resident's stay in the facility, as well as for program payment. We believe that the current wording of this section [including the verb "ensure"] acknowledges the limitations imposed by . . . recognized pathology and the normal aging process, by enabling the facility to demonstrate that based on available clinical evidence, a negative care outcome was unavoidable.

56 Fed. Reg. 48,826, 48,850 (1991) (emphasis added). An appellate panel of the Departmental Appeals Board has interpreted the regulation to require that "a facility . . . go beyond merely what seems reasonable to do, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester Pavilion, DAB No. 1750 (2000). Significantly, in Wellington Specialty Care & Rehabilitation Center, DAB CR548 (1998) an appellate panel held that "[a]n unavoidable pressure sore is one which develops despite the use of aggressive preventive and treatment measures mandated under the applicable standard of care."

Thus, it is clear that the regulations require facilities to intervene aggressively to care for residents who suffer from conditions that may put them at increased risk of developing pressure sores. For this reason, Petitioner cannot carry its burden of proving that George B.'s pressure sores were clinically unavoidable simply by pointing to the resident's diagnoses. Furthermore, while the facility implemented a number of interventions, including an air mattress and a wound care consultation, these interventions were implemented only after George B. had developed numerous pressure sores. Accordingly, Petitioner cannot prove that George B.'s pressure sores developed "despite the use of aggressive preventive and treatment measures."

Petitioner argues additionally that George B.'s attending physician concluded that George B.'s pressure sores were clinically unavoidable. P. Br. at 12. The record in this case includes a note written and signed by Dr. Nagle on November 4, 1999, in which he opines: "Skin breakdown unavoidable. Finally G-Tube placed but significant breakdown occurred because of PVD [peripheral vascular disease], stasis, dermatitis, recovery slow." P. Ex. 1, at 77; see also P. Ex. 4, at 4. Petitioner argues that I should give greater weight to the physician's opinion than to that of the registered nurse surveyor who opined that George B.'s pressure sores were avoidable. P. Br. at 12.

Under some circumstances, I might conclude that the opinion of a medical doctor is entitled to more weight than that of a registered nurse. In the present case, however, I conclude that the opinion of the nurse surveyor is more reliable, and I give it more weight than that of the physician, for the following reasons. First, Ms. Davis, the nurse surveyor, appeared at the hearing, during which she testified under oath and was subject to cross-examination. Dr. Nagle did not appear at the hearing; hence, his opinion was not subject to cross-examination. ⁽⁵⁾ Nor did Petitioner offer Dr. Nagle's opinion in the form of an affidavit; neither Dr. Nagle's note in the chart nor his letter was affirmed under penalty of perjury. Second, Dr. Nagle's opinion is stated as a conclusion with little, if any, discussion of the analytical process which led him to this conclusion. Finally, and perhaps most significantly, as far as the record shows, Dr. Nagle did not express concern that George B's pressure sores might be unavoidable when the resident first began to develop the sores. Rather, Dr. Nagle first expressed that opinion only after it became apparent that George B.'s condition would have a serious negative impact both for the resident and for the facility.

Dr. Nagle's progress note (P. Ex. 1, at 77) is dated November 4, 1999. By that time, George B.'s condition had already deteriorated to the point that his right leg had been amputated. The timing of the note suggests the possibility that it may have been written, in part, with the expectation that George B.'s poor outcome might give rise to litigation. Similarly, Dr. Nagle's letter of November 17, 1999 was expressly written in response to the State Agency's recommendation to CMS, documented in the Form 2567, that Petitioner be found out of compliance with Medicare participation requirements. The State Agency had transmitted the 2567 to Petitioner by letter dated November 12, 1999.

For all these reasons, I decline to rely on the opinion of Dr. Nagle. Instead, I conclude that George B., a resident who entered the facility without pressure sores, developed pressure sores while in the facility, in violation of 42 C.F.R. § 483.25(c). I further conclude that the facility has not proved by a preponderance of the evidence that George B.'s pressure sores were clinically unavoidable.

2. The amount of the per instance CMP imposed against Petitioner, $2,800, is reasonable.

Having found a basis for imposing a per instance CMP, I now consider whether the amount imposed is reasonable, applying the four factors listed in 42 C.F.R. § 488.438(f). See CarePlex of Silver Spring, DAB No. 1683, at 8 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). My "inquiry should be whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved." CarePlex, DAB No. 1683, at 8.

CMS imposed a penalty of $2,800, which is only $1,800 above the $1,000 mandatory minimum and well below the $10,000 maximum for per instance CMPs. With respect to the factors listed at 42 C.F.R. § 488.438(f), the deficiency was serious: George B. suffered actual harm which resulted in him being hospitalized for an above-the-knee amputation. Moreover, the facility bears some culpability for George B.'s poor outcome, due to its failure to institute aggressive prevention and treatment measures in a timely fashion. I conclude that these factors, without more, justify the imposition of a penalty above the minimum, and I find CMS's determination to be reasonable.

Petitioner offered the testimony of David Zabo, the Chief Financial Officer of Petitioner's parent corporation for the proposition that the facility's financial condition precluded its ablity to pay the per instance CMP. Mr. Zabo testified that the facility was experiencing declining patient census and negative cash flow and estimated that it would post losses in the current year. Tr. 174-75. Mr. Zabo did not testify that the payment of a per instance CMP of $2,800 would put the facility out of business. In fact, Mr. Zabo's testimony on direct did not address the impact of the per instance CMP at all. On cross-examination, Mr. Zabo did suggest that payment of the per instance CMP might affect the facility's ability to provide care to its patients. Tr. 177. He suggested that the facility might have its electric or telephone service cut off. Id. This testimony was purely speculative, however, and I accord it little weight. Taken as a whole, Mr. Zabo's testimony did not establish any specific or credible evidence that paying the per instance CMP would be unduly burdensome to the facility.

CONCLUSION

For all of the reasons discussed above, I uphold CMS's determination that the facility was out of compliance with the program participation requirement for Quality of Care. The amount of the per instance CMP imposed, $2,800, is reasonable.

Alfonso J. Montano

Administrative Law Judge

1. The Health Care Financing Administration has been renamed the Centers for Medicare & Medicaid Services (CMS).

2. I refer to the resident by his first name and last initial to protect his privacy.

3. I am unable to state with certainty whether or not the DPNA was imposed. In its opening statement at the hearing, CMS did not mention the DPNA. Tr. 16. CMS's post-hearing brief mentions the DPNA only once, in the conclusion. CMS Br. at 25. I do not find, among the exhibits, any document which states when Petitioner was found to have returned to substantial compliance. Given that I find Petitioner to have been out of substantial compliance, however, CMS was authorized to impose the remedies of DPNA or CMP, or both.

4. Petitioner's brief could be read to suggest that CMS has the burden of proving that the resident's pressure sores were avoidable. See P. Br. at 17. Such an argument is unsupportable in light of the decision in Koester Pavilion, DAB No. 1750 (2000).

5. In a Ruling dated October 11, 2001, I concluded that an in-person hearing was necessary in this case because the ultimate issue turned on my weighing the probative value of the opinions of Dr. Nagle and Ms. Davis. I stated that, to assess the reliability of the opinions of Dr. Nagle and Ms. Davis, I would need to observe the witnesses' demeanor during their testimony. Again, during a telephone conference with the parties on October 22, 2001, I stressed to Petitioner the importance of having Dr. Nagle appear at the hearing. Nevertheless, Petitioner did not choose to call him as a witness.