Healthcare Center of Orange County, DAB CR6440 (2024)

DECISION

I enter summary judgment in favor of the Centers for Medicare & Medicaid Services and against Petitioner, Healthcare Center of Orange County, a skilled nursing facility, finding that Petitioner failed to comply substantially with Medicare participation requirements.  I sustain CMS’s determination to impose a remedy against Petitioner, consisting of a per-instance civil money penalty of $10,650.

I. Background

This case was originally assigned to another administrative law judge.  It was transferred to my docket in autumn  2023.  The record included a fully briefed motion for summary judgment.

On December 12, 2023, I sent an order to the parties directing them to file additional briefing.  The parties complied with that order.  See Order Directing Additional Briefing.

CMS filed a total of 17 exhibits.  These included 13 exhibits, identified as CMS Ex. 1 – CMS Ex. 13 that CMS filed with its pre-hearing exchange and four additional exhibits, identified as CMS Ex. 14 – CMS Ex. 17, that CMS filed in response to my December 12,

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2023, order.¹  Petitioner filed a total of 22 exhibits, identified as P. Ex. 1 – P. Ex. 22.  I do not receive any of these exhibits into evidence because I issue summary judgment based on undisputed material facts.  However, I cite to some of the exhibits in this decision to illustrate facts that are undisputed or to address a party’s argument.

II. Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues are whether Petitioner failed to comply with one or more Medicare participation requirements and whether CMS’s remedy determination is reasonable.

B. Findings of Fact and Conclusions of Law

In deciding whether to issue summary judgment, I apply the principles of Rule 56 of the Federal Rules of Civil Procedure.  I decide the case based only on undisputed material facts.  I make no credibility findings.  I draw all reasonable inferences from the facts that are favorable to the party opposing the summary judgment motion.  I do not grant summary judgment unless the undisputed material facts establish that Petitioner was noncompliant with Medicare participation requirements and that CMS’s remedy determination is reasonable.

1. Noncompliance

CMS initially alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(b)(1).  This subsection states a skilled nursing facility’s obligations to provide care to its residents to prevent the development of, and to treat, pressure ulcers.  CMS premised its case on the care that Petitioner gave to a resident who is identified as Resident 1.  It is undisputed that Resident 1 was admitted to Petitioner’s facility on January 16, 2021, with an ulcer on his right heel.  It is undisputed also that this ulcer deteriorated greatly between January 16 and April 5, 2021.  As of April 5, the resident had an intractable infection so severe that it required below-the-knee amputation of his right leg.  CMS Ex. 9.

CMS argued that Petitioner’s care of Resident 1 violated the requirements of 42 C.F.R. § 483.25(b)(1)(ii), which states that a resident with a pressure ulcer or ulcers:  “receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.”  Petitioner countered this argument by asserting that it could not legitimately be held accountable for failing to comply with this subsection because Resident 1 did not have a pressure ulcer on

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his foot.  Rather, according to Petitioner, the resident suffered from a diabetic ulcer, a condition that is caused by poor blood circulation rather than excessive pressure on the skin.  According to Petitioner, the treatment regime for a diabetic ulcer is different from that provided for a pressure ulcer.  Consequently, it argues, 42 C.F.R. § 483.25(b)(1)(ii) is entirely inapplicable.

In my December 12, 2023 order, I directed that the parties brief the question of whether the regulation applies equally to the care provided for pressure ulcers and diabetic ulcers.  CMS contends that the regulation does, arguing essentially that the two forms of ulcer are sufficiently analogous that the regulation’s language encompasses the treatment of both forms.  Petitioner opposes this assertion relying on the fundamentally different causes of the two ulcers, their prognoses, and treatments.

I find it unnecessary to resolve the question of whether the regulation encompasses diabetic ulcers in addition to pressure ulcers.  Petitioner is noncompliant with regulations governing skilled nursing facilities if it fails to provide care of a quality that met professional practice standards even if that care does not fall specifically under the subsection governing treatment of pressure ulcers.²  I find that Petitioner’s care of Resident 1 was deficient as a failure to provide care consistent with professional practice standards as required by the overall quality of care requirements of 42 C.F.R. § 483.25.  I find also that Petitioner failed to provide foot care to Resident 1 as is required by 42 C.F.R. § 483.25(b)(2)(i).  Finally, I find that Petitioner’s care of the resident was neglect within the meaning of 42 C.F.R. §§ 483.5 and 483.12.

Subsection 483.25(b)(1)(ii) is part of 42 C.F.R. § 483.25, a regulation governing the quality of care that a facility owes to its residents.  The overall regulation requires a facility to provide care that is consistent with professional practice standards and the resident’s comprehensive care plan.  Failure to provide such care to a resident is deficient even if it does not involve the treatment of pressure sores.  Moreover, 42 C.F.R. § 483.25(b)(2)(i) requires a skilled nursing facility to provide foot care and treatment to a resident in accordance with professional standards of practice including care to prevent a resident from sustaining complications from underlying medical conditions.  This subsection does not distinguish between pressure ulcers and diabetic ulcers.

A failure to provide requisite care to a resident may also be neglect, defined as the failure by a skilled nursing facility to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish, or emotional distress. 42 C.F.R. §§ 483.5, 483.12.

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Petitioner’s care of Resident 1 was deficient in the following respects:

• Its staff failed to document or assess the deterioration of Resident 1’s diabetic ulcer during a period that began at the end of January 2021 and that continued through April 5 of that year;
• Staff failed to consult with the resident’s treating physician during the period when the resident’s ulcer deteriorated;
• Staff failed to obtain renewed treatment orders from the resident’s treating physician; and
• Staff failed on several occasions to document that they had provided care to the resident consistent with his physician’s order. 

This failure to provide care to Resident 1 was a fundamental failure to provide the care that a skilled nursing facility is expected to give.  It does not matter whether the resident’s condition was a pressure ulcer or a diabetic ulcer nor does it matter whether he had a poor prognosis for improvement or recovery.  Petitioner’s staff were obligated to assess the resident’s ongoing condition and to be alert to signs of deterioration, to consult with the resident’s physician about changes in the resident’s condition, to document the care that they provided to the resident, and to assure that the resident’s treatment orders were current.  They failed to meet these obligations.  CMS Ex. 11 at 3, ¶ 16.  That failure is the basis for my conclusion that the undisputed material facts establish Petitioner to have been noncompliant with participation requirements.

The following facts are undisputed and material.

On January 16, 2021, Resident 1 was admitted to Petitioner’s facility with a 3 x 3 centimeter ulcer on his right heel, subsequently diagnosed to be a diabetic ulcer.  CMS Ex. 3 at 2; CMS Ex. 4.  The resident’s treating physician issued an order that was effective until February 27, 2021.  CMS Ex. 5 at 1.  The order directed that the resident’s ulcer be treated daily – it was to be cleaned, treated with iodine, and wrapped in gauze.  Id.  The physician renewed the order on February 28, 2021, effective until March 28, 2021.  Id.

The physician did not renew the order after March 28 even though Resident 1 remained at the facility until at least April 5, 2021.  Nothing in the record shows that Petitioner’s staff consulted with the physician about the resident’s condition as of March 28, 2021, or on any date prior to that.

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The resident’s treatment record fails to show that Resident 1 consistently received care for his ulcer as prescribed by his physician.  There is nothing in the record to show that the resident received prescribed care on March 6, 7, 13, 14, or 20, 2021.  CMS Ex. 6 at 3.

Petitioner’s staff prepared progress notes that ostensibly documented the condition of the resident’s ulcer.  From January 21, 2021, until April 2, 2021, the notes say the same thing – that the resident’s ulcer was unchanged in size and was dry and stable.  CMS Ex. 4.  A change was only noted on April 2, 2021, when whomever entered it stated that there was a foul odor and drainage.  CMS Ex. 4 at 2.

On April 5, 2021, only four days after the resident’s ulcer was recorded as being dry, stable, and unchanged in size, a physician found that the ulcer measured 8 x 8 centimeters, covering more than six times the surface area of the last record of the ulcer’s size.  CMS Ex. 8 at 1.  The physician found active purulent drainage with abscess, and that the ulceration and abscess extended to the resident’s bone.  Id.  The resident’s condition had deteriorated so dramatically that he required below-the-knee amputation of his right leg.  Id.; CMS Ex. 9.

The only reasonable conclusion that I can draw from the extensive deterioration of Resident 1’s condition between late January and April 2021 is that, despite staff’s statements that his ulcer remained stable, it was not stable throughout the period but rather, deteriorated.  There is no other possible reasonable explanation for the ulcer being measured as having increased six-fold in surface area and extending all the way to the bone on April 5, 2021.  That conclusion leads inexorably to another:  Petitioner’s staff did not actively observe or document the deterioration of the resident’s condition, nor did they consult with the resident’s treating physician during the period from late January through early April 2021 while the resident’s ulcer was worsening.

I do not find that Petitioner has established a dispute as to the material facts that I have discussed.  Additional arguments that Petitioner raises are irrelevant to my findings of noncompliance.

Petitioner disputes none of the facts that I have identified that describe the care that its staff gave to Resident 1.  To be specific, Petitioner does not deny that its staff failed to obtain an updated treatment order for the resident after March 28.  It does not deny that on the dates that I have cited there exists no documentation of the care that its staff was supposed to provide.  It does not deny that its staff consistently purported to observe the resident’s ulcer as unchanged.  It does not deny that the staff failed to consult with the resident’s physician about the deterioration of the resident’s ulcer.

Furthermore, Petitioner does not present any facts that contradict my conclusion that the resident’s diabetic ulcer deteriorated over the period beginning in late January 2021 and

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continuing through the beginning of April.  It has not, for example, offered the testimony of a health care professional who asserts that the ulcer was stable until April 2.

Petitioner asserts that it disputes CMS’s fact allegations because they rely on “uncorroborated and unreliable allegations of the surveyor [who surveyed Petitioner’s facility on behalf of CMS] and a deficient investigation wherein the surveyor ignored or misconstrued important evidence.”  Petitioner Healthcare Center of Orange County’s Response in Opposition to the Centers for Medicare and Medicaid Service’s Motion for Summary Judgment (Petitioner’s response) at 1-2.  However, Petitioner does not identify any specific facts identified by the surveyor that it disputes.  See CMS Ex. 11.

There is an obvious difference between fact and opinion.  I do not rely on anyone’s opinion – including the surveyor’s – in identifying the facts of this case that are undisputed.  Those undisputed facts – which I have described above – are found in Petitioner’s own resident treatment records.

I do cite the surveyor’s opinion that Petitioner failed to comply with practice standards in providing care to Resident 1.  CMS Ex. 11 at 3, ¶ 16.  But Petitioner does not challenge this opinion.  It offers no expert testimony asserting that Petitioner complied with professional practice standards.  Nor does it offer opinion that contradicts the surveyor’s finding that Petitioner’s staff violated basic nursing care standards of practice.  It offers no evidence to argue, for example, that failure to obtain a renewed physician’s treatment order complies with professional practice standards.  Nor does it assert that staff’s failure to consult with the resident’s physician about the obvious deterioration of the resident’s diabetic ulcer was consistent with acceptable practice standards.  In short, Petitioner leaves unchallenged the surveyor’s conclusion that Petitioner’s staff failed to provide care consistent with basic nursing requirements.

Although Petitioner asserts that the surveyor ignored or misconstrued allegedly important evidence, it fails to describe what that evidence consists of and why it raises fact issues that might change the outcome of this case.

Petitioner asserts that it should have the opportunity to cross-examine the surveyor to establish the inconsistencies or false premises in his testimony.  Cross-examination would certainly be appropriate if Petitioner could articulate what inconsistencies or false premises exist and explain how they are relevant to this case’s outcome.  But Petitioner has failed to do so.  As I have explained, the material facts in this case are undisputed and are found in Petitioner’s own resident treatment records.  As for the surveyor’s opinions, I have explained that his opinion about Petitioner’s failure to comply with basic nursing care requirements was not challenged by Petitioner.

The bulk of Petitioner’s argument in opposition to CMS’s motion is that CMS has conflated pressure ulcers with diabetic ulcers and is unfairly holding Petitioner to

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regulatory requirements that are inapplicable to this case.  Petitioner’s response at 6-8.  It summarizes its argument by stating:  “[T]he fact that Resident 1 had a diabetic ulcer and it did not heal or get worse is not prima facie evidence of a violation of . . . [42 C.F.R. § 483.25(b)(1)].”  Petitioner’s response at 8.

As I have explained, I make no finding in this decision that Petitioner failed to comply with the pressure ulcer treatment requirements of 42 C.F.R. § 483.25(b)(1).  Petitioner plainly failed to comply with other, closely related requirements that I have described above.

2. Remedy

The sole remedy in this case is a per-instance civil money penalty of $10,650.  I find it to be reasonable and I sustain it.

Per-instance penalties are authorized by 42 C.F.R. § 488.438(a)(2).  The penalty that CMS determined to impose against Petitioner is relatively modest, amounting to about one-half of the maximum allowable per-instance penalty.  45 C.F.R. Part 102.

Deciding whether a penalty amount is reasonable depends on evidence relating to regulatory factors that may include the seriousness of a facility’s noncompliance, its compliance history, its culpability for noncompliance and its financial condition.  42 C.F.R. §§ 488.438(f)(1)-(4); 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  Neither CMS nor Petitioner briefed the issue of whether the penalty amount that CMS determined to impose is reasonable.  I am therefore left to consider whether this penalty is reasonable without input from the parties.

I find the penalty amount to be reasonable based on the seriousness of Petitioner’s noncompliance.  The noncompliance was very serious because Petitioner’s staff failed to provide basic nursing services to treat a medical condition that could result in physical disfigurement (amputation in this case) or worse.  Failure to provide basic nursing services to Resident 1 thereby had the potential for seriously harming him.  It is unnecessary that I conclude that the failures exhibited by Petitioner’s staff in this case caused Resident 1 to be harmed.  Rather, it is enough to say that the potential for serious harm existed.

Endnotes

¹ CMS Ex. 14 – CMS Ex. 17 are excerpts from an internal CMS policy document, the State Operations Manual.  This document is publicly available.

² In my December 12, 2023 order, I advised the parties that I was identifying new issues pursuant to the authority granted to me at 42 C.F.R. § 498.56.  Order Directing Additional Briefing at 2.