Oak Ridge Center, DAB No. 3195 (2025)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Oak Ridge Center (Petitioner), a Medicare-participating skilled nursing facility (SNF), challenges a civil money penalty (CMP) imposed by the Centers for Medicare & Medicaid Services (CMS) for noncompliance with the Medicare participation requirement in 42 C.F.R. §  483.25.1  The case is before the Board for a second time.  In 2018, the Board affirmed a grant of summary judgment by the Administrative Law Judge (ALJ) in favor of CMS on its claim that from September 15, 2015, through May 12, 2016, Petitioner was not in substantial compliance with section 483.25 because of multiple failures by its nursing staff to provide residents with prescribed or otherwise necessary diabetes care.  See Oak Ridge Ctr., DAB No. 2913 (2018).  However, the Board remanded the case to the ALJ for further proceedings to review CMS’s finding that the noncompliance was at the immediate-jeopardy level of severity.  Id.  On remand, the ALJ conducted an in-person evidentiary hearing and then, on July 17, 2019, issued a decision sustaining the immediate-jeopardy finding.  Oak Ridge Ctr., DAB CR5376 (2019) (ALJ Decision).  The ALJ also determined that the $5,900 per day CMP that CMS had imposed for the period of immediate-jeopardy-level noncompliance was reasonable.  Id.  Petitioner now seeks Board review of the ALJ’s decision on remand.  For the reasons stated below, we affirm the ALJ decision.

CASE BACKGROUND

1. Medicare compliance survey and CMS enforcement action

This case stems from a May 2016 Medicare compliance survey performed by the West Virginia Department of Health and Human Resources (survey agency).  DAB No. 2913,

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at 3.  Based on its review of clinical records for five diabetic residents – identified here as Residents 75, 71, 55, 37, and 10 – the survey agency found that:

• Certain nursing staff members withheld (did not administer) insulin that had been prescribed for a resident without first consulting with the resident’s prescribing physician or practitioner;
• Petitioner’s nursing staff did not consistently carry out a physician’s order to notify the physician if a resident’s blood glucose exceeded 300 milligrams per deciliter of blood (mg/dl);
• On five occasions involving two different residents, Petitioner’s nursing staff did not implement an established hypoglycemia protocol after discovering that the resident’s blood glucose was less than 70 mg/dl;
• Due to an incorrectly transcribed physician order, Petitioner’s nursing staff failed to administer a resident’s evening dose of long-acting insulin for eight consecutive days; and
• In one instance, the nursing staff failed to obtain a hemoglobin A1c test ordered by the resident’s physician or nurse practitioner.  (The hemoglobin A1c test measures a person’s average blood glucose level for the past two to three months.)

Id. at 4-5.  The survey agency found that these errors or omissions demonstrated lack of substantial compliance with 42 C.F.R. §  483.25 (id. at 5), which at the time stated that a SNF must provide each resident with “necessary care and services” to enable the resident to “attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.”  42 C.F.R. § 483.25 (Oct. 1, 2015).  The survey agency further determined that:  Petitioner’s noncompliance with section 483.25 had placed residents in immediate jeopardy beginning on September 15, 2015; residents’ immediate jeopardy was not abated until the evening of May 12, 2016; and Petitioner remained out of substantial compliance with section 483.25 and other Medicare participation requirements at a lower level of severity after May 12, 2016.  DAB No. 2913, at 5.

Concurring with the survey agency’s findings, CMS imposed a $5,900 per day CMP for the immediate-jeopardy period (September 15, 2015, through May 12, 2016) and reduced the CMP to $250 per day as of May 13, 2016.  Id.  (The lesser penalty accrued from May 13 through late August 2016.  Id.; CMS Ex. 27, at 22.)

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2. Petitioner’s hearing request and CMS’s summary judgment motion

Petitioner requested a hearing to challenge CMS’s determination of immediate-jeopardy-level noncompliance and its imposition of the $5,900 per day CMP.  See Oct. 28, 2016 Req. for Hr’g at 1-2.2  CMS then moved for summary judgment, asking the ALJ to sustain both its determination that the diabetes-care errors and omissions documented by the survey agency constituted lack of substantial compliance with section 483.25, and its finding that the alleged noncompliance had placed residents in immediate jeopardy.  DAB No. 2913, at 6.  Petitioner opposed CMS’s motion, and both parties proffered evidence supporting their respective positions.  Id.  Among other material, CMS proffered records of the nursing care rendered to Residents 75, 71, 55, 37, and 10 – the five residents whose care the survey agency found deficient – as well as written direct testimony by:  (1) three state agency surveyors – Rebecca Lucas, Joyce Settle, and Pamela Russell – who participated in the May 2016 survey (CMS Ex. 27); (2) Lisa Pollard-Ray, a CMS surveyor who participated in the May 2016 survey in order to assess its quality (CMS Ex. 28); and (3) A. Jefferson Lesesne, M.D., a board-certified internist and geriatrician (CMS Ex. 29).3  Id.

Petitioner’s evidence included:

• A 2010 clinical practice guideline authored by the AMDA – The Society for Post-Acute and Long-Term Care Medicine (AMDA), titled “Diabetes Management in the Long-Term Care Setting.”  P. Ex. 1.  (We refer to this document as the “AMDA Guideline.”)
• The 2015 version of the AMDA Guideline (P. Ex. 2);
• A 2016 “position statement” by the American Diabetes Association (ADA), titled “Management of Diabetes in Long-term Care and Skilled Nursing Facilities” (P. Ex. 3).

Petitioner also proffered written direct testimony from:  Steven A. Levenson, M.D., Multifacility Medical Director at Genesis ElderCare (Petitioner’s corporate owner) and a member of the committee that drafted the AMDA Guideline (P. Ex. 30); Holly Estel, R.N., a vice-president of clinical operations at Genesis ElderCare (P. Ex. 31); and Naushira Pandya, M.D., Chair of the Department of Geriatrics at Nova Southeast University College of Osteopathic Medicine (Nova Southeast), Project Director of the

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Geriatric Education Center at Nova Southeast, and chair of the committee that drafted the AMDA Guideline (P. Ex. 32).  DAB No. 2913, at 6.

3. ALJ decision granting summary judgment to CMS

On June 13, 2017, the ALJ issued a decision granting summary judgment to CMS and sustaining the $5,900 per day CMP that accrued from September 15, 2015, through May 12, 2016.  Oak Ridge Ctr., DAB CR4865.  The ALJ concluded that there were no genuine disputes of material fact, and that CMS was entitled to judgment on its noncompliance claim because undisputed facts showed that, during the relevant period, Petitioner’s staff failed to provide diabetes care to residents in accordance with physician orders, resident care plans, and a written hypoglycemia protocol.  Id. at 2-3.  Applying the review standard in 42 C.F.R. § 498.60(c)(2), the ALJ further concluded that CMS’s finding that Petitioner’s noncompliance had placed residents in immediate jeopardy during the relevant period was not clearly erroneous.  Id. at 4-9.  In reaching these conclusions, the ALJ ruled on certain objections by CMS to portions of Petitioner’s witness declarations.  Id. at 6-7.  Notably, the ALJ ruled that written direct testimony of Petitioner’s witnesses should be excluded to the extent it was based on statements that the witnesses attributed to facility employees (or other “third parties”) from whom there was no written direct testimony.  Id.  Finally, the ALJ sustained the contested $5,900 per day CMP because Petitioner had not, the ALJ found, presented “any argument or facts to show” that the penalty is “unreasonable.”  Id. at 10.

4. First Board decision upholding grant of summary judgment in part and remanding case to ALJ

Petitioner appealed the ALJ’s June 13, 2017 decision to the Board, which affirmed the grant of summary judgment in part.  In reaching its conclusions, the Board found the following facts regarding residents 75, 71, 55, 37, and 10 to be undisputed:

• Resident 75 (76 years old during the survey):  Although Resident 75 had a physician’s order for a 15-unit dose of insulin each morning, Petitioner’s nursing staff withheld the morning (6:00 a.m.) dose on February 13, 2016 (when the resident’s blood glucose was 89), February 15, 2016 (when her blood glucose was 91), and February 17, 2016 (when her blood glucose was 106).  DAB No. 2913, at 9.  The survey agency found no contemporaneous documentation of the nursing staff’s reason(s) for withholding the prescribed doses, no record that the nursing staff had sought approval to withhold them, and no record that the staff notified the resident’s physician that the doses had been withheld.  Id.
• Resident 71 (86 years old during the survey):  In late April 2016, Resident 17 had an order for 18-unit doses of Lantus (long-acting insulin) every 12 hours – the first 18-unit dose in the morning, and the second in the evening.  DAB No. 2913,

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• at 9-10.  Progress notes from March and April 2016 reflect concern about the resident’s “‘uncontrolled’” or “suboptimal[ly] control[led]” blood glucose levels.  Id. (citing or quoting CMS Ex. 1B at 10; and CMS Ex. 14A at 20-21, 41).  On May 3, 2016, a nurse practitioner issued an order continuing the 18-unit evening dose but increasing the morning dose to 20 units.  Id. at 10.  However, because the May 3rd order to continue the evening dose was erroneously transcribed in the resident’s charts as an order to stop it, the resident did not receive an evening dose of Lantus from May 3 until May 11, when the transcription error was caught.  Id.  After seeing Resident 71 on May 11, 2016, the nurse practitioner wrote that the resident’s “‘blood sugars have not improved, and have actually worsened with more episodes of hyperglycemia.’”  Id. (quoting CMS Ex. 14A, at 17).
• Resident 55 (59 years old during the survey):  In April 2016, Resident 55, a type 1 diabetic, had a physician order for Lantus at bedtime.  DAB No. 2913, at 10.  However, nursing records show, and Petitioner did not dispute, that Resident 55 did not receive her bedtime dose of Lantus on April 10, 2016.  Id. at 10-11.
• Resident 37 (81 years old during the survey):  As of September 2015, Resident 37 had a physician order for insulin at 6:00 a.m., 11:00 a.m., and 4:00 p.m., and at bedtime, as well as an order instructing staff to measure her blood glucose twice a day and to report any measurement less than 70 or more than 300 mg/dl.  DAB No. 2913, at 11.
  • From September 15, 2015, through at least April 19, 2016, there were 31 occasions on which a nursing staff member withheld Resident 37’s prescribed 6:00 a.m. dose of insulin after obtaining blood glucose measurement ranging from 72 to 109.4  See id. at 12.  In each instance, there is “no record that the nurse [who withheld the morning dose] consulted with the resident’s medical practitioner in advance about withholding insulin, or any record that the practitioner was informed about the withholding after the fact.”  Id.
  • On October 20, 2015, the nursing staff found that Resident 37’s 6:00 a.m. blood glucose was 66.  Id. at 13.  “Under Petitioner’s then-existing Hypoglycemia Protocol, if a resident’s blood glucose dropped below 70 (or some other physician-established threshold) and the resident was asymptomatic, the nursing staff was expected to take all of the following steps:  (1) hold all diabetic medications; (2) administer a rapidly absorbed

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• simple carbohydrate; (3) if meal time, have patient eat meal; (4) repeat blood glucose measurement in 10-15 minutes and notify the physician if no improvement; (5) obtain follow-up orders regarding diabetic medications and glucose monitoring; and (6) follow with meal or snack within one hour.”  Id. (internal quotation marks and brackets omitted) (citing and quoting CMS Ex. 1A at 59, and CMS Ex. 9, at 2).  After obtaining the sub-70 blood glucose reading on October 20, 2015, LPN5 withheld Resident 37’s 6:00 a.m. dose of insulin.  DAB No. 2913, at 13.  “However, surveyors found no evidence in the record that the hypoglycemia protocol was initiated for Resident #37 on that occasion.”  Id. (internal quotation marks and brackets omitted).
• Resident 10 (84 years old during the survey):  Resident 10’s blood glucose was not well-controlled, and it ranged widely at times.  DAB No. 2913, at 13.  From April 30, 2015, through at least April 28, 2016, Resident 10 had a physician’s order directing the nursing staff to measure the resident’s blood glucose twice daily and to notify her physician if the result was less than 70 or more than 300 mg/dl.  Id.  Resident also had a standing order for an hemoglobin A1c test to be performed every three months.  Id. at 5, 14.
  • From September 4, 2015, through April 19, 2016, there were eleven occasions on which Resident 10’s blood glucose exceeded 300 but there was no documentation that nursing staff notified Resident 10’s physician or nurse practitioner of that measurement.  Id. at 14.  On one of these eleven occasions, after Petitioner failed to report a 6:00 a.m. blood glucose level of 318, the resident’s blood glucose level rose to 545 later in the day, prompting the staff to call the resident’s physician, who ordered the administration of short-acting insulin.  Id.  Surveyors identified 12 additional occasions during the same seven-month period when nursing staff notified Resident 10’s medical practitioner of a blood glucose reading exceeding 300 and the practitioner responded by ordering short-acting insulin to treat the hyperglycemia.  Id.
  • On January 10, January 16, February 29, and April 6, 2016, Resident 10’s blood glucose fell below 70, but there is no record of the nursing staff having notified the resident’s physician or followed Petitioner’s hypoglycemia protocol to address that condition.  Id.
  • Petitioner did not comply with a physician’s order to obtain a hemoglobin A1c test result for Resident 10 every three months.  Id. at 15.  Petitioner obtained an A1c test in August 2015 but did not obtain another test until  

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• January 2016, more than three months later.5  Id.; see also CMS Ex. 1B at 7.

In addition to identifying undisputed facts concerning the care rendered to Residents 75, 71, 55, 37, and 10, the Board considered the written direct testimony of the parties’ proposed witnesses.  CMS’s expert, Dr. Lesesne, testified that:

• “The normal blood glucose level of a healthy adult is generally accepted to be in the range of 80-110,” and “[w]hen blood glucose levels fall outside of that range, serious conditions can develop.”
• Episodes of hyper- and hypoglycemia can have short- and long-term adverse health consequences.  Immediate short-term consequences of hyperglycemia include dehydration, low blood pressure, and altered mental status.
• “[E]xtremely high blood sugar levels far above the normal range that are not timely addressed are more likely to result in serious immediate symptoms than blood sugar levels that are just slightly above the normal range.”
• Symptoms of hypoglycemia, which is any blood glucose level less than 80, “can develop rapidly” and include “altered mental condition, confusion, lethargy, increased sweating, and seizures.”
• “Hypoglycemia is a very serious condition, and if not treated quickly, can lead to coma and death.”
• Because episodes of hypoglycemia are potentially life-threatening, “most nursing homes develop and implement a Hypoglycemia protocol to ensure that nursing staff addresses immediately the emergent needs of an individual experiencing a hypoglycemic incident.”
• Petitioner’s failure to administer prescribed insulin to Residents 75, 71, 55, and 37 placed those residents “at risk of developing hyperglycemia” and of experiencing harmful complications associated with that condition, including dehydration, low blood pressure, altered mental status, vascular damage (affecting organs), and worsening of coexisting medical problems.
• The failure of Petitioner’s nursing staff to comply with an order to notify a medical practitioner about Resident 10’s high blood glucose levels exceeding 300

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• mg/dl posed a risk of harm from hyperglycemia and made it possible that the resident’s blood glucose would “escalate further and subject the resident to more serious immediate and long term consequences.”
• Petitioner’s failure to implement or fully implement its hypoglycemia protocol after obtaining blood glucose levels below 70 “posed a risk of serious bodily injury or death for Residents 10 and 37.”

CMS Ex. 29, ¶¶ 20-22, 29-33, 45, 47-48, 50-51, 53-54, 60, 63-64, 69.

In their written testimony, Petitioner’s proposed witnesses acknowledged the desirability of maintaining glucose within a clinically appropriate range and avoiding extremely high or low (or extreme fluctuations in) blood glucose levels.  P. Ex. 32, at 5-6 (stating that “both AMDA and the ADA recognize the desirable target range in long term care residents now is considered to be between 100 and 200,” that the AMDA “recognizes that isolated blood sugar test results outside these ranges are not necessarily problematic” (italics added) (implying that results outside the range may be problematic)); P. Ex. 30, at 6 (same).  In addition, Petitioner’s witnesses did not dispute statements by Dr. Lesesne that episodic hyper- and hypoglycemia, which some residents experienced, can have immediate adverse health consequences.  However, Petitioner’s witnesses asserted that none of the nursing staff’s allegedly deficient care posed a risk of serious harm to the residents involved, observing that the affected residents all “exhibited blood sugar level fluctuations typical of [diabetes] in elderly patients” and “received considerable amounts of insulin daily”; that none appeared to be “at risk for short term complications”; that nurses’ decisions to withhold insulin appeared to be “consistent with trying to project the subject residents from harm due to overtreatment”; and that later scheduled insulin doses would have treated any hyperglycemia resulting from the missed doses.  P. Ex. 30, at 4, 6; P. Ex. 32, at 4, 6-7.

Both parties’ proposed witnesses (Dr. Lesesne and Surveyor Pollard-Ray for CMS, and Dr. Levenson, Dr. Pandya, and Nurse Estel for Petitioner) indicated that nurses generally should follow physician orders as written and consult with a medical practitioner before modifying an order or withholding a medication.  DAB No. 2913, at 16, 17.

Based on the above-recounted undisputed facts, proposed witness testimony, and other record material, the Board affirmed the grant of summary judgment to CMS on its claim that Petitioner was noncompliant with 42 C.F.R. § 483.25 from September 15, 2015, through May 12, 2016.  Id. at 9-29.  The Board concluded that Petitioner violated section 483.25 by failing to carry out medical practitioners’ orders for treating or monitoring residents’ diabetes and by not implementing its hypoglycemia protocol in circumstances when it should have been implemented.  Id. at 21.  The Board further concluded that opinions expressed by CMS’s witnesses, and the undisputed facts upon which those opinions were based, demonstrated that Petitioner’s violations of section 483.25 had at

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least the potential to cause “more than minimal” harm to residents, and that Petitioner’s witnesses did not raise a genuine dispute about whether the violations had such potential.  Id. at 23.

The Board, however, reversed the grant of summary judgment on CMS’s claim that its immediate-jeopardy finding was not clearly erroneous.  Id. at 29-35.  In doing so, the Board noted that CMS’s declarations “create[d] some uncertainty about whether [its] experts thought that the cited nursing errors had caused serious harm or were likely to cause such harm (if not corrected)”; that “CMS’s primary rationale for seeking summary judgment” on the immediate-jeopardy issue – namely, “the alleged ‘systemic’ nature of Petitioner’s noncompliance” – “rest[ed] on disputed facts or inferences”; and that CMS “appear[ed] to [have] concede[d] that Petitioner’s expert opinions sufficed to raise a genuine dispute about whether its nursing errors created an ‘immediate’ risk of serious harm or death.”  Id. at 30, 31, 32, 35.  The Board accordingly remanded the case for further proceedings on the immediate-jeopardy issue.

5. Hearing on remand

On remand, the ALJ held an evidentiary hearing during which Petitioner cross-examined Dr. Lesesne and Nurse Pollard-Ray, and CMS cross-examined Dr. Levenson, Dr. Pandya, and Nurse Estel.  Tr. 27, 132, 159, 182, 209.  At the outset of the hearing, the ALJ denied Petitioner’s request to cross-examine the three state agency surveyors whose declarations CMS had proffered in support of its motion for summary judgment.  Tr. 5-6, 8-24; see also CMS Ex. 27, at 1, 12, 17 (declarations of Rebecca Lucas, Joyce Settle, and Pamela Russell).  The ALJ also reaffirmed his earlier ruling excluding portions of the written direct testimony of Petitioner’s witnesses.  Tr. 5-6.

During the in-person hearing, Dr. Lesesne testified that in his professional opinion:

• The failure of Petitioner’s staff to implement its hypoglycemia protocol was likely to cause serious harm to residents who experienced hypoglycemia – harm that could “come on in a number of hours” (Tr. 114-17, 124);
• The failure of Petitioner’s nursing staff to give Resident 71 a prescribed dose of night-time long-acting insulin for eight consecutive days caused actual harm to the resident and “increased the likelihood of some significant harm or injury” to the resident (Tr. 112-14);
• Failure to administer prescribed insulin may result in hyperglycemia, and persistent hyperglycemia (blood glucose consistently over 180) puts a person at “great risk” of dehydration, a condition that is not always visible to caregivers but is likely to result in serious harm to an elderly nursing home resident if not addressed (Tr. 77, 105-08);

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• Failure to report an episode of blood glucose over 300 “potentially put [the resident] at risk” of harm from consequences or complications of hyperglycemia, such as dehydration (Tr. 78-79);
• The nursing staff’s errors and omissions created a systemic risk of serious harm to the facility’s diabetic residents.  See Tr. 119 (indicating that “the systemic risk” of harm to residents from Petitioner’s diabetes management failures was “more concerning tha[n] any individual one instance of, you know, failing to follow an order”); CMS Ex. 29, ¶¶ 39, 41 (noting that a “pattern” of deficient practices, involving multiple staff members, created a risk of serious harm to all of Petitioner’s diabetic residents, including a “risk of hyperglycemia and all of the symptoms and consequences that accompany a hyperglycemic episode”).

Nurse Pollard-Ray testified that failing to administer insulin in accordance with physicians’ orders increased the likelihood of hyperglycemia, changes in blood pressure and mental status, and respiratory distress.  Tr. 144.  She also suggested that nursing staff who disregarded a physician order for insulin administration might disregard a physician order for “another medication that might be more detrimental to a resident.”  Tr. 143.

During his cross-examination and redirect testimony, Dr. Levenson reaffirmed his previously stated opinion that Petitioner’s deficiencies neither caused, nor were likely to cause, serious harm to the residents involved.  See Tr. 162-64, 179-80, 184-85, 192-93, 203-04.  Asserting that not every nursing error or omission “poses an equally serious impact on residents,” and that “serious implications and complications” of diabetes “appear over a prolonged period of time, not in the shorter intermediate term,” Dr. Levenson maintained that Petitioner’s deficiencies did not pose a risk of serious harm because they “were intermittent and over a period of time,” did not constitute a “pattern” of nursing error, and were mitigated by “things [that] happened in the interim, in between the errors” (such as residents receiving prescribed care).  Tr. 193, 195, 196, 203, 204.  In  addition, Dr. Pandya suggested that no serious harm was likely to result from the staff’s withholding of prescribed insulin because nursing records show that the withholding occurred only when residents’ blood glucose was low.  Tr. 185-86.

6. Post-hearing briefing

The parties submitted post-hearing briefs to the ALJ.  Asserting that its witnesses “gave credible testimony . . . regarding the likelihood and seriousness of risks that the facility’s noncompliance posed to residents” (CMS Post-Hr’g Br. at 4), CMS urged the ALJ to sustain the immediate-jeopardy finding on the following four grounds.

First, CMS argued that the finding was justified based on the failure of Petitioner’s staff to follow its own hypoglycemia protocol in circumstances requiring that it be followed.

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CMS Post-Hr’g Br. at 5-7.  In support of that proposition, CMS claimed that “Dr.  Lesesne testified, without contradiction, that a resident was likely to experience serious risk of harm from hypoglycemic episodes, including coma or death, within a matter of hours,” and that Petitioner’s failures to follow the hypoglycemia protocol were “pervasive” and therefore “increased the likelihood that serious harm” would result.  Id. (citing Tr. 116).

Second, CMS asserted that failures by Petitioner’s staff to report blood glucose measurements above or below thresholds specified by a resident’s physician were also likely to cause serious harm to diabetic residents.  Id. at 7-8.  Characterizing these failures as “common” during the relevant period, CMS asserted that Petitioner’s “staff’s pattern of disregarding notification orders created the likelihood that they would notify a physician only when the resident was critically hyperglycemic or had a very elevated blood sugar level instead of notifying the physician early on, potentially avoiding that situation entirely.”  Id.  “Because staff were inconsistent in reporting blood sugar levels to physicians as required,” said CMS, “physicians were unable to make changes to resident treatment plans to address those levels when necessary.”  Id. at 8.

Third, CMS contended that Petitioner’s failure to provide a prescribed evening dose of Lantus (long-acting insulin) to Resident 71 for eight consecutive days “created a likelihood of harm for Resident 71.”  Id. at 8.  In support of that contention, CMS stated that Resident 71 “already had poorly controlled blood sugar and hyperglycemia” before the error occurred; that because of the staff’s error, “the resident went for 14 hours each day for eight days without any type of assessment or intervention”; that “Dr. Lesesne credibly testified that th[e] error increased the likelihood of significant harm or injury to the resident” – harm that, according to Nurse Pollard-Ray, included elevated blood glucose, change in blood pressure, change in mental status, and respiratory distress; that “Resident 71’s own nurse practitioner stated in a follow-up visit that the resident’s blood sugars had worsened during the period when staff discontinued the resident’s Lantus”; and that Resident 71’s “record also showed increased instances of hyperglycemia that, again, went unreported until the resident’s follow-up visit.”  Id. at 8-9 (citing Tr. 114-15, 144; and CMS Ex. 14A, at 17-18).

Finally, CMS contended that the record shows a “systemic and troubling pattern” of nurses “ignor[ing],” “disregard[ing],” or otherwise failing to comply with medical practitioners’ orders and failing to inform the practitioners of such failures – a pattern that, according to CMS, put all residents, not just diabetic residents, at risk of serious harm.  Id. at 9-10.  In support of that contention, CMS asserted that Petitioner’s noncompliance “w[as] not isolated to a handful of errors committed by just one nurse”; that Petitioner’s nurses “repeatedly disregarded physician orders and facility policies”; and that two of Petitioner’s nurses indicated during survey interviews that it was within their discretion to administer or hold prescribed medication, displaying misunderstanding of the proper scope of nursing practice.  Id. at 9 (citing CMS Ex. 1B at 1-2, 8).

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According to CMS, the nursing staff’s apparent disregard of physician orders, and “propensity to apply their ‘nursing judgment’ haphazardly” and arbitrarily, demonstrated that it was likely that “an LPN or RN could withhold medication or other lifesaving measures (such as the hypoglycemia protocol) at any time.”  Id. at 10.  “So long as the facility’s nurses continued to misunderstand the scope of their practice and commit errors,” said CMS, “there was a high probability that someone would eventually suffer serious injury.”  Id. at 9-10.  CMS asserted that these points are supported by the testimony of Dr. Lesesne and Nurse Pollard-Ray.  Id. (citing Tr. 92, 143).

In its post-hearing brief, Petitioner argued that CMS’s immediate-jeopardy finding is clearly erroneous because AMDA and ADA practice guidelines (which Petitioner says embody “modern standards” of diabetes care), testimony by its medical experts (Dr. Levenson and Dr. Pandya), and the “context” of the nursing staff’s errors or omissions (including the fact that the residents involved had “overlapping insulin orders”) collectively demonstrate that Petitioner’s noncompliance did not cause, and was unlikely to cause, serious harm to Residents 75, 71, 55, 37, and 10.  Pet.’s Post-Hr’g Br. at 5, 7, 9, 10-15.  Petitioner asserted that AMDA and ADA guidelines call for a resident’s physician to be notified of asymptomatic high or low blood glucose readings only “when blood glucose is low for two consecutive measurements or high on consecutive days.”  Id. at 16.  According to Petitioner, these notification parameters, coupled with the guidelines’ “emphasis on long term blood glucose trends and overall resident status” (rather than frequent blood glucose measurements and “retrospective response to every blood glucose fluctuation”), illustrate that Petitioner’s nursing errors or omissions were “unlikely to have any clinical consequence at all” because they involved residents who were experiencing only “asymptomatic transient” hyperglycemia or hypoglycemia (that is, sporadic or isolated, rather than prolonged or repeated, episodes of abnormally high or low blood glucose).  Id. at 10, 12-13, 16 (further asserting that “asymptomatic transient high and low blood glucose . . . ordinarily do[es] not indicate that the patient is [at] any risk of harm, and ordinarily do[es] not require intervention”).

Petitioner also objected to the notion that its failures to perform prescribed diabetes care meant that its staff would likely fail to provide other prescribed care and to cause serious harm as a result.  “[A]fter CMS alleges ‘immediate jeopardy’ based upon specific allegations of noncompliance,” said Petitioner, “an ALJ may not – as a matter of law – extrapolate such a determination from other bad things that might happen” – that is, the immediate jeopardy determination must be based on the “‘likely’ consequences of the cited noncompliance,” not noncompliance or deficient care that might later occur.  Id. at 4, 8 (further asserting that the regulations “require a specific ‘remedy’ to be based on the likely consequences of the specific noncompliance that CMS cites and the ALJ sustains” (italics in original)).

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7. The ALJ’s decision on remand

In his decision on remand, the ALJ concluded that CMS’s immediate-jeopardy finding was not clearly erroneous because the record disclosed one or more “reasonable bas[e]s” for that finding.  DAB CR5376, at 5.  Relying on Dr. Lesesne’s testimony, the ALJ found that CMS had reasonably determined that Petitioner’s failure to implement (or to produce documentation that its staff had implemented) its own hypoglycemia protocol – a failure the ALJ called “particularly alarming – “created the likelihood that one or more diabetic residents would suffer coma or death.”  Id. (citing Tr. 124).  “As Dr. Lesesne testified,” said the ALJ, “hypoglycemia can lead to devastating consequences in a very short period of time,” and for that reason “Petitioner’s [hypoglycemia] protocol required its staff to perform blood sugar rechecks and other measures within strict timeframes whenever a resident’s blood sugar fell below 70” – measures that the staff indisputably failed to take on three occasions when they were called for.  Id. at 5-6.  The ALJ further found, again citing Dr. Lesesne’s testimony, that Petitioner’s staff’s “consistent failure to report” episodes of hyperglycemia to residents’ physicians was a “reasonable basis” for the immediate-jeopardy finding, stating that “hyperglycemia likely will have serious adverse consequences if untreated in the long run,” and that “[s]taff’s frequent failures to notify physicians of residents’ hyperglycemia, despite physicians’ orders that they do so, easily supports the inference that, eventually, a resident or residents likely would be harmed seriously.”  Id. at 6 (citing CMS Ex. 29, ¶¶ 29-34, and Tr. 116, 122-24).

In addition, the ALJ found a reasonable basis for the immediate-jeopardy finding in what he called the “persistent and frequent failure to follow physicians’ explicit orders,” explaining:

. . . [S]taff repeatedly failed to notify physicians that residents’ blood sugar levels exceeded defined parameters, despite very clear orders that they do so.  I have discussed how blood sugar levels outside of normal ranges (hyper- or hypoglycemia) likely would eventually cause serious harm, injury, or death to residents.  But, the failure to follow orders raises issues that go beyond the diabetes-related consequences of that failure.

The record offers no rationale for Petitioner’s staff failing to follow physicians’ orders other than indifference, misunderstanding, or neglect on their part.  There is no documentation in the record showing that the staff assessed residents and determined that it was not in the residents’ interest to notify treating physicians of blood sugar results that exceeded defined parameters.  There is no analysis, no discussion, nothing, from which I could infer that the nursing staff made some sort of reasoned judgment about when and under what circumstances to notify treating physicians.  Of course, even if staff had made such judgment, that would have constituted a

gross violation of nursing standards of care and a dereliction of duty to residents.

It is entirely reasonable to infer that the staff’s systemic failure to follow physicians’ orders extended beyond the specific orders issued for diabetic residents.  These failures by the staff quite reasonably suggest that the staff failed wholesale to carry out its responsibilities.  That caused a likelihood of serious injury, harm, or death not just to diabetic residents of Petitioner’s facility, but additionally to all residents because it meant that the staff would likely disregard a physician’s order in circumstances other than providing diabetes care where the risk of serious injury, harm, or death, was apparent.

Carrying out the orders of a physician is an essential element of nursing.  A skilled nurse – even a highly trained one – may not disregard an order issued by a physician.  If that nurse questions the order, he or she may, and indeed should, consult with the physician.  In such a consultation, the nurse may request that the order be rescinded or modified.  But under no circumstance may a nurse disregard the order.  That is violation of a fundamental precept of nursing care.

Id. at 6-7.

The ALJ acknowledged that some nursing staff members reported during survey interviews that they had withheld insulin depending on the residents’ current blood glucose levels and on how recently they had eaten.  Id. at 8.  However, the ALJ found “nothing in the nursing notes or other treatment records that corroborates these assertions,” which he called “a post hoc rationalization for failure to provide care consistent with physicians’ orders.”  Id.  The ALJ also found that Petitioner’s diabetic residents were “fortunate that the staff’s tempting of fate did not harm them seriously while these violations [of physician orders] were ongoing,” and that “[i]t is perfectly reasonable to infer . . . that continued noncompliance likely would eventually cause some resident or residents to suffer serious injury, harm, or death given that staff recorded no logical basis for their noncompliance.”  Id.

The ALJ found the AMDA and ADA clinical practice guidelines “irrelevant to the issue of immediate jeopardy level noncompliance . . . because Petitioner offered no evidence to show that its staff members were attempting to follow these guidelines or even were aware of their existence.”  Id. at 8.  The ALJ added:  “[t]he possibility that blood sugars recorded by Petitioner’s residents may have coincidentally fallen into a range of variations that the guidelines suggest is not harmful says nothing about whether Petitioner’s staff were prone to committing systemic and multiple errors that likely would cause serious injury, harm, or death to residents.”  Id. at 8-9.

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As for Petitioner’s witness testimony, the ALJ found it “unpersuasive in key respects.”  Id. at 9.  He found that Dr. Levenson had based his opinion that the noncompliance was unlikely to cause serious harm on an erroneous assumption that Petitioner’s nursing staff failed to carry out physician orders only when it thought the result would be “benign” (the ALJ’s word).  Id. (citing Tr. 193-98).  In fact, said the ALJ, the record is “devoid of evidence” that the nursing staff made reasoned judgments, based on resident assessments, about whether to follow physician orders.  Id.  According to the ALJ, the record merely shows that the staff “simply ignored physicians’ orders wholesale.”  Id. at 9-10.  The ALJ also found that Dr. Levenson had attempted to “rationalize Petitioner’s staff’s noncompliance by asserting that the noncompliance constituted a deliberate attempt by Petitioner’s staff to withdraw or withhold treatment from residents with limited life expectancies in accord with AMDA guidelines” – an assertion that the ALJ called “pure conjecture . . ., unsupported by anything in the record.”  Id. at 10.

Regarding Dr. Pandya’s opinion that none of Petitioner’s noncompliance was likely to cause serious harm, the ALJ found it “beg[ged] the question of whether continued commission of [diabetes care] errors by staff would likely cause serious harm, injury, or death in the future.”  Id. at 10.  According to Petitioner, Dr. Pandya’s answer to that question “rel[ied] on the staff’s good luck” in avoiding resident harm “and not on anything suggesting that [Petitioner’s nursing] staff could distinguish between a serious error and a benign one.”  Id. (citing P. Ex. 30, at 4).  The ALJ also found no “evidentiary support” for Dr. Pandya’s opinion that the nursing staff’s failure to follow physician orders (or other noncompliance) was “consistent with trying to protect the subject residents from harm due to overtreatment.”  Id. (quoting P. Ex. 32, at 4).  And the ALJ disputed Dr. Pandya’s suggestion that residents would have promptly alerted the nursing staff to – and thus substantially mitigated – adverse symptoms resulting from the staff’s noncompliance, finding the suggestion to be “contradicted” by the AMDA Guideline’s statements that residents “‘frequently are unable to perceive or communicate hypoglycemic symptoms’” and that symptoms of hyperglycemia “are often atypical in the elderly nursing facility population, and thus, not necessarily easy for staff to perceive.”  Id. (quoting or citing P. Ex. 1, at 9, 32).

The ALJ found Nurse Estel’s testimony “not credible” for reasons similar to those he gave for discounting the testimony of Doctors Pandya and Levenson.  Id. at 11.  He found to be “pure speculation” her suggestion that a nursing staff member likely consulted with a resident’s physician or nurse practitioner within a day or so after any decision to withhold ordered insulin, even though such consultation was not documented in the resident’s clinical records.  Id. at 11 (referring to testimony in CMS Ex. 31, at 2).  There is “absolutely nothing in the record documenting alleged consultations between Petitioner’s staff and physicians or nurse practitioners concerning staff decisions to withhold insulin,” said the ALJ.  Id.

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Finally, the ALJ commented that even if all of Petitioner’s witness testimony is credible, “[a]t most, it serves to create dueling theories as to the level of Petitioner’s noncompliance” and does not establish that Dr. Lesesne’s testimony lacks credibility or “prove that CMS’s theories of immediate jeopardy . . . are unreasonable.”  Id. at 9.

After sustaining the immediate-jeopardy finding, the ALJ determined that Petitioner had “waived” any challenge to the reasonableness of the $5,900 per day CMP that CMS had imposed for the period of immediate jeopardy while stating that he had nonetheless “considered the penalty amounts pursuant to regulatory standards and . . . f[ound] them to be reasonable.”  Id. at 12.  Finally, the ALJ stated that Petitioner had waived any challenge to the “duration” of its immediate-jeopardy-level noncompliance.  Id.

STANDARD OF REVIEW

The Board’s standard of review on a disputed factual issue is whether substantial evidence in the record as a whole supports the ALJ’s decision, and our standard of review on a disputed legal issue is whether the ALJ’s decision is erroneous.  Guidelines – Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s Participation in the Medicare and Medicaid Programs (Guidelines), available at www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/ participation/index.html.

“Substantial evidence” means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”  Richardson v. Perales, 402 U.S. 389, 401 (1971) (quoting Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938)).  “When reviewing for substantial evidence, the Board reviews the whole record, considering both what supports the ALJ’s decision and what undercuts it.”  Golden Living Ctr. – Riverchase, DAB No. 2314, at 18 (2010), aff’d, 429 F. App’x 895 (11th Cir. 2011) (per curiam).  However, “the Board does not make credibility findings, re-weigh the evidence, or substitute its evaluation of the evidence for that of the ALJ.”  Five Star Healthcare, LLC, DAB No. 3089, at 8 (2023) (internal quotation marks omitted).

ANALYSIS

In its request for review of the ALJ’s decision on remand, Petitioner contends that the ALJ should have found CMS’s immediate-jeopardy finding to be clearly erroneous.  Request for Review (RR) at 1, 8, 32.  In support of that contention, Petitioner restates the contentions and arguments made to the ALJ in its post-hearing brief.  In general, Petitioner submits that CMS failed to establish that its noncompliance was likely to cause serious harm to “any of the subject residents” (referring to Residents 75, 71, 55, 37, and 10), and that its own witnesses, whom it called “national experts with many decades of providing resident care,” “unambiguously testified that it was scientifically unlikely – if not impossible – for the noncompliance CMS asserted and the Board sustained to cause

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death or serious harm to any of the subject residents, or to anyone similarly situated.”  RR at 9-10, 12.

In addition to challenging the ALJ’s affirmance of CMS’s immediate jeopardy finding, Petitioner raises what it calls a “preliminary evidentiary issue” – namely, its disagreement with the ALJ’s rulings that:  (1) excluded portions of the written direct testimony of Petitioner’s witnesses; and (2) denied Petitioner the opportunity to cross-examine the state agency surveyors whose declarations CMS submitted in support of its summary judgment motion.  RR at 17.  We address Petitioner’s disagreement with the evidentiary rulings first.

1. The ALJ’s evidentiary rulings do not warrant reversal or modification of the ALJ Decision because Petitioner has failed to show the rulings were abuses of discretion or prejudicial.
2. Exclusion of statements attributed to non-witnesses in Petitioner’s written direct testimony.

In both his initial decision and decision on remand, the ALJ found that the declarations of Dr. Levenson, Dr. Pandya, and Nurse Estel (Petitioner’s witnesses) included “statements that the declarants attribute[d] to employees of Petitioner’s facility, including its director of nursing or nurses who treated the residents whose care is at issue.”  DAB CR4865, at 6; see also DAB CR5376, at 2; Tr. 5-6, 11-14.  The ALJ found that his pre-hearing order required that such statements be proffered “as written direct testimony made under oath if [a party] wanted me to consider them,” and that admitting the statements through the witnesses’ declarations was “unfair to CMS” because it had no “opportunity to challenge [the statements’] veracity.”  DAB CR4865, at 6-7; DAB CR5376, at 2 n.1.  The ALJ therefore excluded from the record any statements in Petitioner’s declarations that the declarants attributed “to individuals [including Petitioner’s director of nursing] for whom Petitioner had not provided written direct testimony.”  DAB CR5376, at 2 (footnote omitted); see also DAB CR4865, at 6-7 (“exclud[ing] all of the statements that are attributed [by Petitioner’s witnesses] to third parties because they violate the pre-hearing order that I issued in this case”); Tr. 5-6, 11-14.

Petitioner states that it is “not entirely clear exactly what portions of [its witnesses’ written direct] testimony the ALJ actually purported to strike,” although Petitioner understands that the exclusion covered “portions of Petitioner’s experts’ testimony that referred to information learned [by the witnesses] from other sources and persons, including the [facility’s] staff.”  RR at 13, 14.  Regardless of what statements the ALJ intended to exclude, or actually excluded, Petitioner suggests that the ALJ erred because the ruling reflects a “completely wrong” understanding of “expert testimony” and its presentation under Rule 703 of the Federal Rules of Evidence.  RR at 14.  In general, Petitioner contends that the excluded statements (to the extent any can be identified) are

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admissible because they constitute the foundation for the “experts’ opinions.”  RR at 14-15.6  CMS responds that the ALJ properly “excluded the hearsay portions of Oak Ridge’s expert testimony because it failed to comply with” the pre-hearing order and seeks to have “hearsay testimony admitted as ‘facts’ or ‘evidence’ . . . even though [it] is not reliable or credible at all.”  Response Br. at 30.

In administrative hearings governed by 42 C.F.R. Part 498, ALJs have considerable discretion in deciding whether to admit or exclude evidence.  Cf. Rockcastle Health & Rehab. Ctr., DAB No. 2891, at 23 (2018) (stating that an ALJ has “wide latitude within the context of Part 498 proceedings to decide whether any particular piece of evidence is relevant and material, and may exclude evidence that she determines is not relevant and material”).  Accordingly, we review a ruling to exclude evidence for abuse of discretion.  See HeartFlow, Inc., DAB No. 2781, at 19 (2017) (finding “no reason . . . to conclude that the ALJ abused his discretion in excluding . . . evidence as irrelevant”).  Even when an evidentiary ruling constitutes an abuse of discretion, the Board will not vacate or modify the ALJ’s decision on that basis absent a showing that the improper ruling was prejudicial.  Copperas Cove LTC Partners, DAB No. 3049, at 33 (2021) (internal quotation marks omitted) (citing authorities); Board Guidelines, “Completion of the Review Process,” ¶ (c) (indicating that the possible bases for modifying or reversing a decision by the Administrative Law Judge include a “prejudicial error of procedure (including an abuse of discretion under the law or applicable regulations)” (italics added)).

Petitioner has not alleged or demonstrated an abuse of discretion.  It does not take issue with the ALJ’s finding that the pre-hearing order required that any third-party statements reflected in a witness’s declaration be themselves proffered as written direct testimony.  In general, an ALJ does not err or abuse his discretion in excluding evidence that a party fails, without reasonable justification, to proffer in a form or manner, or at a time, required by the ALJ’s pre-hearing order.  Cf. Carrington Place of Muscatine, DAB No. 2321, at 10 n.10 (2010) (holding that the ALJ did not abuse his discretion in refusing to admit notes that a party should have included with its pre-hearing exchange, as required

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by the ALJ’s pre-hearing order).  An evidentiary ruling’s inconsistency with the Federal Rules of Evidence does not necessarily constitute an abuse of discretion because those rules do not apply in this proceeding.  Lakeport Skilled Nursing Ctr., DAB No. 2435, at 6 (2012) (Federal Rules of Evidence and Civil Procedure do not apply to Part 498 proceedings).  Petitioner has not in any event shown that the ALJ’s ruling – requiring it to submit third-party “statements” reflected in its expert witness declarations as written direct testimony – is inconsistent with Federal Rule 703, whose language Petitioner does not quote or specifically discuss.  See RR at 14-15.

Even if the ALJ’s ruling was an abuse of discretion, we decline to disturb the ALJ’s decision on that basis because Petitioner has not shown that the ruling was actually prejudicial – that it deprived Petitioner of an opportunity to address dispositive compliance issues and respond to CMS’s presentation, thereby potentially affecting the outcome.  Cf. Douglas Bradley, M.D., DAB No. 2663, at 5-6 (2015) (applying a “harmless error” standard by considering whether an error affecting a party’s ability to cross-examine witnesses “possibly affected the outcome,” and holding that the party was not in fact prejudiced by the error because the outcome would have been the same in absence of witness testimony).  Petitioner asserts that prejudice from the ruling is “obvious” because the ALJ did not consider “the full evidentiary basis for its experts’ opinions.”  RR at 15.  However, Petitioner makes no attempt to show how the ruling affected the ALJ’s assessment of opinions expressed by Petitioner’s witnesses.  Petitioner does not explain why the ALJ would have found its witnesses more credible, or would have assigned greater weight to their testimony, had the ALJ not excluded certain material from their written direct testimony.  Nor does Petitioner point to any specific witness opinion that the ALJ discounted or rejected on account of it being based on an excluded statement.  Finally, Petitioner does not point to any line of questioning or argumentation that it was unable to pursue or develop adequately because of the challenged ruling.

2. Preclusion of cross-examination of state agency’s surveyors

As noted, the ALJ barred cross-examination of the three surveyors whose declarations CMS proffered at the summary judgment stage of the case.  In support of that ruling, the ALJ stated that the surveyors’ “factfindings” (regarding the care rendered to Residents 75, 71, 55, 37, and 10) were “not at issue” during the hearing on remand, “having been sustained by the Board’s appellate panel.”  DAB CR5376, at 2.  “Moreover,” said the ALJ, “any opinion that the[ ] surveyors might offer as to whether Petitioner’s noncompliance amounts to immediate jeopardy is irrelevant because it is a legal opinion that the surveyors are not qualified to make,” and “I make no findings of immediate jeopardy in this case based on surveyors’ opinions as to that issue.”  Id.  Petitioner concedes that any opinions expressed by the surveyors concerning the propriety of the immediate jeopardy finding are “irrelevant” but suggests that it needed to cross-examine the surveyors about other matters.  RR at 16.

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“[T]he conduct of the hearing rests generally in the ALJ’s discretion,” and “[t]hat principle extends to the limitations and ground rules ALJs may establish for cross-examination.”  Copperas Cove at 32 (internal quotation marks omitted).  In general, an ALJ “has discretion to limit the scope of cross-examination where the result does not substantively impair the ability to decide the issue presented on a full, fair record.”  Id. at 32-33 (internal quotation marks omitted).  In other words, a party is entitled to cross-examination “as necessary for a full and fair adjudication of the facts.”  Citizens Awareness Network, Inc. v. United States, 391 F.3d 338, 351 (1st Cir. 2004) (noting further that “[t]he [Administrative Procedure Act, 5 U.S.C. § 551 et seq.,] does not provide an absolute right to cross-examination in on-the-record hearings”); 5 U.S.C. § 556(d) (entitling a party to “such cross-examination as may be required for a full and true disclosure of the facts” while authorizing exclusion of “irrelevant, immaterial, or unduly repetitious evidence”).  The Board will not vacate or modify an ALJ’s decision based on a ruling that prohibited, or limited, the scope of, cross-examination absent a demonstration by the appellant that the ruling was prejudicial.  Copperas Cove at 33-34.  To show prejudice from such a ruling, a party must specify how the ALJ’s limitation on cross-examination “impaired its ability to litigate specific issues material to the outcome of the proceeding” – for example, by “alleg[ing] that it was prevented from examining witnesses about testimony” upon which the ALJ relied to reach his conclusions.  Carrington Place of Muscatine at 23.

Petitioner has shown no abuse of discretion by the ALJ in precluding cross-examination of the state agency surveyors.  Petitioner does not point to specific parts of the surveyors’ written direct testimony and explain how cross-examination of that testimony was necessary to ensure “full and fair adjudication” of specific facts or information about which they testified.  Even if the ALJ’s prohibition on cross-examination was an abuse of discretion, we decline to disturb the ALJ’s decision on that basis because Petitioner has shown no prejudice stemming from its inability to conduct cross-examination.  In sustaining the immediate-jeopardy finding, the ALJ did not rely to Petitioner’s detriment on any surveyor testimony whose truthfulness or reliability could have been undermined on cross-examination.  Furthermore, Petitioner had an adequate opportunity to challenge the immediate-jeopardy finding through its own evidence, including expert-witness testimony.

Petitioner asserts that it needed to cross-examine the surveyors about facts omitted from the Statement of Deficiencies, asserting that such an inquiry “bears upon the completeness and reliability of the factual basis for the conclusions CMS – and eventually the ALJ – drew, and would draw, from that record.”  RR at 16.  However, Petitioner does not indicate what facts it thinks were omitted, indicate how they might have influenced CMS’s finding regarding the seriousness of the noncompliance, or explain why it could not have established such facts with its own documentary evidence and witness testimony.

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Petitioner also contends that cross-examination was necessary to establish that the surveyors – two of whom, Petitioner emphasized, were not licensed or registered nurses (but instead had educational and professional backgrounds in social work and nursing home administration) – “did not consider, or did not understand, all of the medical and scientific evidence that it is pertinent to that determination.”  RR at 16.  Petitioner asserts that it might have questioned the surveyors about whether their “judgments regarding the potential impact of the errors and omissions they cited” were based on consideration of “current standards of care.”  RR at 17.  In short, Petitioner suggests that cross-examination was necessary to reveal how, or by what analytical process, the surveyors reached their conclusion about the seriousness of Petitioner’s noncompliance.

We find these points unpersuasive.  Petitioner’s suggestion that the survey agency’s judgment concerning the level of noncompliance is tainted by surveyors’ lack of nursing credentials overlooks the fact that the survey was led by a registered nurse, Joyce Settle, and that the immediate-jeopardy finding was made by the entire survey team with the concurrence of program managers and supervisors in the West Virginia Department of Health and Human Resources.  See CMS Ex. 27, at 1, 8-9, 12, 14-20.  Petitioner’s suggestion also overlooks the fact that the challenged immediate-jeopardy finding was made by CMS based on its own independent assessment of the survey results.  A survey agency’s noncompliance and level-of-noncompliance findings constitute recommendations to CMS, which may defend those findings based on analysis, reasoning, and evidence that that may differ from, or supplement, what the survey agency relied upon.  See 42 C.F.R. §§ 488.10(a)(1), 488.11(a) (indicating that survey agency makes “recommendations” about whether SNFs meet Medicare conditions of participation); Avon Nursing Home, DAB No. 2830, at 14 (2017) (stating that a “state agency’s survey findings constitute recommendations to CMS,” and that “CMS makes its own determination of noncompliance, and decides what enforcement action to take, based on the survey’s findings”); Golden Living Ctr. – Superior, DAB No. 2768, at 8 n.4 (2017) (holding that “CMS may defend a noncompliance determination [before the ALJ] based on facts, evidence, or reasoning not specified in the Statement of Deficiencies, provided . . . that due process requirements – adequate notice and a meaningful opportunity to be heard – are satisfied,” and rejecting argument that it was improper for CMS to “articulate a rationale for the noncompliance determination that differs from the one advanced by the state survey agency”).  Moreover, we see nothing in the record indicating that CMS’s immediate-jeopardy finding was made by – or rested solely on judgments of – employees lacking nursing experience or knowledge of relevant standards of care.  CMS employee Lisa Pollard-Ray, a registered nurse, participated in the survey in an oversight role, concurred with the survey agency’s noncompliance and immediate jeopardy findings, and testified in support of those findings.  CMS Ex. 28, at 2-4.  Petitioner had ample opportunity to cross-examine Nurse Pollard-Ray and fails to explain why that opportunity was inadequate under the circumstances.

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2. CMS’s immediate jeopardy finding was not clearly erroneous.

We turn to Petitioner’s challenge to CMS’s immediate jeopardy finding.  As noted, “immediate jeopardy” is defined in CMS’s regulations as “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  An immediate-jeopardy finding must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).

Under the clearly-erroneous standard of review, CMS’s immediate-jeopardy finding is “presumed to be correct,” and the SNF bears a “heavy burden” to upset it.  Vibra Hosp. of Charleston – TCU, DAB No. 3094, at 22 (2023).  Deference is owed to an immediate-jeopardy finding because “‘distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries,’” and because determining whether a deficiency is likely to cause serious harm often entails application of professional medical or nursing judgment or expertise.  Daughters of Miriam Ctr., DAB No. 2067, at 10 n.7, 15 (2007) (quoting Medicare and Medicaid Programs; Survey, Certification and Enforcement of Skilled Nursing Facilities and Nursing Facilities, 59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994)).

“Immediate jeopardy exists if a SNF’s noncompliance is the type of noncompliance that would likely cause serious injury, harm, impairment, or death if not corrected, even if surveyors did not observe or identify a particular resident who was actually threatened with harm during the survey.”  Liberty Commons Nursing & Rehab. Ctr. - Johnson, DAB No. 2031, at 19 (2006) (emphasis in original), aff’d, 241 F. App’x 76, 80 (4th Cir. 2007).  In other words, an immediate-jeopardy finding is not clearly erroneous if the nature of the noncompliance, and the conditions enabling it, are such that they would “likely . . . result in serious harm, not only to the resident or residents whose circumstances triggered the immediate jeopardy determination, but to the facility’s population at large.”  Daughters of Miriam Ctr. at 12 (citing Liberty Commons); see also Medford Care Ctr. DAB No. 3040, at 17 n.13 (2021) (noting the holdings in Liberty Commons and Daughters of Miriam).  When an immediate-jeopardy finding is based on multiple instances of deficient care or failures to comply with one or more regulatory standards, the facility seeking to overturn that finding “must demonstrate that all the failures relied upon, i.e., the ‘totality’ of its noncompliance, did not create the likelihood of serious injury or harm to any resident.”  Bibb Med. Ctr. Nursing Home, DAB No. 2457, at 4 (2012); see also Nightingale Home Healthcare, Inc., DAB No. 2784, at 26-27 (2017) (quoting and relying on Bibb, and finding that the home health agency’s immediate-jeopardy argument “mistakenly focuse[d] on whether a particular patient remained in danger rather than whether conditions that created immediate jeopardy for one or more persons were still present”).

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We agree with the ALJ that, in its totality, Petitioner’s noncompliance – including, and especially, the failure of its staff to follow the established hypoglycemia protocol and physician orders to report abnormally high blood glucose values (over 300 mg/dl of blood) – was likely to cause serious harm to one or more diabetic residents if not corrected, and that CMS’s immediate-jeopardy finding was therefore not clearly erroneous.  We agree with the ALJ on this point because:

• There is ample and uncontested evidence that unrecognized or untreated hypoglycemia and hyperglycemia, even when episodic, can cause or result in serious harm to elderly nursing home residents within a short period (see CMS Ex. 29, ¶¶ 22, 29-31, 33; DAB No. 2913, at 18-19);
• Petitioner’s noncompliance involved more-than-occasional failures, spanning several months, to follow physician orders and a resident-care policy designed to ensure that a resident received timely, appropriate treatment to prevent serious harm from hypoglycemia;
• Petitioner presented no evidence that when the diabetes-care failures or omissions occurred, the nursing staff actually recognized – or had procedures or protocols in place to self-identify – the deficiencies and prevent their recurrence; and
• At least two members of Petitioner’s nursing staff indicated during the survey that they could, in their “nursing judgment,” withhold prescribed insulin (medication) without first conferring with the prescribing physician – a fundamental misunderstanding of the scope of nursing practice (see DAB No. 2913, at 15-17 (describing the evidence of the survey agency’s interviews of RN51 and Petitioner’s Director of Nursing, as well as evidence of a nurse’s obligation to administer treatment as ordered and to consult with patient’s physician in advance (absent an emergency) before withholding medication)).

Petitioner does not dispute that episodic hypoglycemia and hyperglycemia, if unaddressed, can result in serious injury or harm to elderly long-term care residents.  See RR at 21 (“As discussed throughout the case, diabetes certainly is a serious chronic disease, and some manifestations and complications of that ailment, whether caused by noncompliance or the disease process itself, obviously are not ‘benign.’”).  Nor does Petitioner point to evidence demonstrating the absence of a causal relationship between its noncompliance and the harm associated with untreated or unrecognized hypo- or hyperglycemia.  For example, Petitioner does not dispute that failure to report an abnormally high blood glucose value in violation of a physician’s order could contribute to causing serious harm (such as altered mental status or dehydration) if the reporting failure prevented or delayed timely intervention to avoid those consequences.

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Petitioner nonetheless maintains that the immediate-jeopardy finding cannot stand because CMS failed to demonstrate that the five residents whose care surveyors cited as deficient were likely to suffer serious harm as a result of the noncompliance.  RR at 10-12, 31-32; Reply Br. at 9-10.  This contention fails for two reasons.  First, it overlooks the fact that CMS has no burden of proof with respect to its immediate jeopardy finding.  “Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy; rather, the burden is on the facility to show that that determination is clearly erroneous.”  Vibra Hosp. at 22 (internal quotation marks omitted).  Second, Petitioner overlooks Board decisions which hold that CMS need not identify a particular resident at risk of serious harm from the noncompliance.  Liberty Commons, DAB No. 2031, at 18 (holding that “immediate jeopardy exists if a SNF’s noncompliance is the type of noncompliance that would likely cause serious injury, harm, impairment, or death if not corrected, even if surveyors did not observe or identify a particular resident who was actually threatened with harm during the survey”); see also Fairfax Nursing Home, Inc., DAB No. 1794, at 13-14 (2001) (stating that “a finding of immediate jeopardy is not contingent on a finding that each individual incident placed a resident at such a degree of potential or risk of serious harm that there was a likelihood of harm to that specific resident at that particular time,” and that “[f]indings about incidents related to individual residents are not themselves the deficiencies that must be corrected” because “the deficiency is the underlying failure to meet a participation requirement evidenced by the incident”), aff’d, 300 F.3d 835 (7th Cir. 2002).

Petitioner asserts that its deficiencies were not the kind likely to cause serious harm, and that this is apparent from “current standards” of diabetes care for long-term care residents.  RR at 6.  These standards, Petitioner says, demonstrate that CMS’s contrary position lacks any “medical or scientific . . . basis . . . and for that reason was ‘clearly erroneous.’”  RR at 9-11 (further stating that “medical and scientific evidence shows that th[e] acts or omissions” cited by CMS as deficiencies “were not of the sorts that could pose the ‘likelihood’ of death or serious harm to any resident”), 25 (asserting that “standards of care . . . help to illuminate the nature, and thus the seriousness, of the errors and omissions CMS cited” (italics in original)).

The “current standards” upon which Petitioner apparently and principally relies are “clinical practice guidelines,” published by the AMDA, for determining when a nursing facility should contact a physician about a resident’s episodes of hypoglycemia and hyperglycemia and “other acute metabolic complications” of diabetes.  See P. Ex. 2, at 41 (“When to Call the Practitioner”); RR at 31 (citing P. Ex. 2, at 41-42).  In relevant part, these guidelines state that “[i]n patients with diabetes, it is generally recommended that the practitioner be called immediately when the patient has a blood glucose value of less than 70mg/dL and is unresponsive or has consecutive blood glucose readings less than 70 mg/dL.”  P. Ex. 2, at 41 (italics in original).  The AMDA guidelines further state that a practitioner “should be called as soon as possible” when (among other circumstances)

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“[t]he patient has blood glucose values greater than 300 mg/dL during all or part of 2 consecutive days (unless this represents an improvement from a recently measured value or existing orders specify how the patient’s hyperglycemia should be managed).”  Id. (italics in original).

Petitioner relies on these guidelines in part to bolster a claim that the multiple failures to report Resident 10’s 300-plus blood glucose levels were not likely to cause the resident serious harm.  According to Petitioner, the AMDA’s physician-notification guidelines for hyperglycemia show that “transient high . . . blood glucose measurements, . . . without more serious or dramatic symptoms, ordinarily do not indicate any risk of harm or require [physician] intervention,” and that because Resident 10 “did not have consecutive high [300 and above] blood glucose measures” and did not experience symptoms associated with hyperglycemia, the resident was not likely to experience serious harm as a result of any of the staff’s failure to notify the resident’s physician about an abnormally high blood glucose level.  RR at 11-12, 25, 31, 32.

One problem with this contention, as the ALJ noted (ALJ Decision at 8), is that nothing in Petitioner’s records indicates that its nursing staff followed the AMDA’s recommendations by assessing Resident 10 for symptoms whenever it obtained a blood glucose measurement exceeding 300 mg/dL.  In addition, both parties’ witnesses testified that the AMDA’s physician-notification guidelines were merely “general principles” and not a standard of care applicable to all residents (or any resident regardless of clinical status), and thus the guidelines’ physician-notification criteria do not necessarily reflect some upper limit to the risk of harm from an episode of abnormally high blood glucose.  See Tr. (Levenson) at 199 (stating the AMDA guidelines merely “recommended approaches” that one “presumes . . . will be applied individually to individual resident[s] in looking at their whole circumstances”); Tr. (Lesesne) at 29-30, 103 (indicating that the AMDA guidelines do not constitute “standards of care” but “tools” for assessing what level of care is necessary and appropriate given a resident’s individual circumstances); P. Ex. 2 (AMDA Guideline), at 22 (indicating that the significance and appropriateness of the clinical practice guidelines for any particular patient may depend on the patient’s individualized treatment goals).  None of Petitioner’s witnesses testified that a physician’s order to report an isolated or non-consecutive blood glucose value greater than 300 was unnecessary to prevent harm to a resident regardless of the clinical circumstances, or that such an order was unnecessary to prevent serious harm to Resident 10.7

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Petitioner also relies on the AMDA guidelines to support its claim that staff failures to follow its hypoglycemia protocol were not problematic.  According to Petitioner, the guidelines show that only “prolonged or repeated” episodes of low blood glucose (below 70 mg/dl) require intervention, and that because all the incidents in which staff failed to implement the protocol involved “transient” hypoglycemia, those failures were not likely to result in serious harm to residents.  RR at 25, 30-31 (stating that “transient . . . low blood glucose measurements, by themselves, that is without more serious or dramatic symptoms, ordinarily doe[es] not indicate any risk of harm, or require any intervention”).  We find this argument unconvincing because it ignores the purpose of the hypoglycemia protocol, which is to ensure timely rapid treatment of hypoglycemia (see CMS Ex. 9).  Nowhere do the AMDA guidelines suggest that such treatment was unnecessary in the affected residents’ circumstances, or that failure to treat asymptomatic hypoglycemia in an elderly resident would not likely have serious repercussions in some cases.

Petitioner asserts that “in every one of the cases CMS cited where the Center’s staff did not document following the Center’s hypoglycemia protocol, the record shows that the resident’s blood glucose level was low in the morning but subsequently increased during the day”; and that “even CMS’ Dr. Lesesne conceded that this evidence compels an inference that a nurse must have performed some intervention, since that result could not occur spontaneously, even if she did not document the specific intervention.”  RR at 30-31 (citing Tr. 63, 65, 88) (italics added).

These assertions ignore the fact that hypoglycemia can “worsen rapidly” and “can quickly become critical” if not treated immediately or urgently (as the facility’s protocol requires).  CMS Ex. 29, ¶ 57.  They also mischaracterize Dr. Lesesne’s testimony.  Dr. Lesesne did not concede that the nursing staff must have deliberately intervened to address the residents’ hypoglycemia, only that the residents may have received a meal at some unspecified point after becoming hypoglycemic.  Moreover, he indicated that the happenstance of a resident receiving a scheduled meal would not necessarily mitigate the risk of harm stemming from failure to initiate the protocol because hypoglycemia requires “immediate” intervention to prevent harmful consequences that “can develop rapidly.”  See Tr. 65-66, 88-90, 115-16 (stating that “low blood sugars are immediately the most dangerous and not following the hypoglycemia protocol is, you know, immediately the most concerning in terms of the risk of harm or death”); CMS Ex. 29, ¶ 33 (noting that such consequences “can develop rapidly,” necessitating an “immediate” response to an episode of hypoglycemia).  In our view, the inference that Petitioner proposes only bolsters the ALJ’s view (ALJ Decision at 8) that Petitioner was “fortunate” that its residents were not actually harmed by its staff’s protocol failures.

Petitioner emphasizes that its expert witnesses “unambiguously testified” that the nursing errors or omissions were unlikely to cause serious harm to the five residents in question.  RR at 12.  However, CMS’s expert, Dr. Lesesne, testified to the contrary (see, e.g., Tr. 92, 114-19, 122-24), and the ALJ, who observed the cross- and redirect examinations

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of both parties’ witnesses (and for that reason was in the best position to evaluate their testimony), assigned more weight to Dr. Lesesne’s testimony and found Petitioner’s witnesses not credible in certain respects.

We defer to an ALJ’s determination of the weight and credibility of witness testimony absent a “compelling” reason to do otherwise.  Five Star Healthcare at 8.  We see no reason not to accord such deference in this case.  Petitioner does not point to any specific material testimony by Dr. Lesesne that it believes is illogical, factually unfounded, inconsistent with other evidence, or based on fundamental misunderstandings of nursing or medical practice standards.  Petitioner merely asks us to reach a different result based on the perceived strength of its so-called “medical and scientific” evidence, by which it evidently means the testimony of Dr. Levenson and Dr. Pandya and the AMDA and ADA clinical practice guidelines.  There being no compelling reason to disturb the ALJ’s weight and credibility determination, we find Dr. Lesesne’s testimony to be substantial evidence that CMS’s immediate-jeopardy finding is not clearly erroneous.

Petitioner makes various other contentions in support of its challenge to the immediate-jeopardy finding, none of which we find meritorious or material to the outcome.  For example, Petitioner suggests that “medical and scientific evidence” shows that the harm threatened by Petitioner’s noncompliance was not distinct or separate from the “potential consequences of the underlying disease itself.”  RR at 9-10.  Petitioner claims that CMS and its expert witness “did not distinguish potential adverse consequences of the disease [diabetes] from potential (or ‘likely’) adverse consequences of the noncompliance” and suggests that it is being improperly held responsible for the former and not the latter.  RR at 4 n.4 (claiming that the immediate-jeopardy finding was clearly erroneous absent evidence that the noncompliance “exacerbated the disease” or was likely to do so).

Petitioner does not cite or discuss evidence supporting these contentions.  On their face the contentions fail to address the harm threatened by at least one element of Petitioner’s noncompliance – namely, staff’s repeated failure to follow its hypoglycemia protocol, whose purpose was to prevent or minimize complications of diabetes treatment.  See P. Ex. 2, at 7 (stating that hypoglycemia is a short-term complication of diabetes treatment).  Furthermore, Petitioner’s assertions are undercut by evidence that, in at least two instances, Petitioner’s noncompliance contributed to a deterioration in a resident’s clinical status.  The first instance was the staff’s failure to provide a daily dose of long-acting insulin to Resident 71.  In the opinion of Dr. Lesesne, that failure resulted in actual harm to the resident – specifically, multiple episodes of hyperglycemia.  CMS Ex. 29, ¶ 62.  In the second instance, staff’s failure to report a blood glucose measurement of 318 for Resident 10 led to a substantial spike (to 545) in blood sugar within a few hours, at which point a physician prescribed an emergency dose of insulin.  CMS Ex. 11A, at 13; CMS Ex. 11B, at 5; CMS Ex. 11E, at 31; see also DAB No. 2913, at 14.  Dr. Lesesne testified that because Resident 10 “was already hyperglycemic,” a failure to notify the

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physician of a blood glucose measurement higher than 300 “put the resident at risk that the blood sugar level would escalate further and subject the resident to more serious immediate and long term consequences.”  CMS Ex. 29, ¶ 69 (italics added).  Based on this and other evidence, it is not unreasonable to suggest that Petitioner’s reporting failure (that is, its noncompliance) could have contributed to a deterioration in the resident’s health because timely reporting of the abnormal test result might have prompted actions to halt further deterioration in the resident’s metabolic status and prevent worsening of “underlying medical conditions.”  See id. ¶ 68 (stating that “[i]t is extremely important for nursing staff to notify the physician of a blood glucose level that is so greatly outside of the normal range so that the physician can have the opportunity to develop the best response to this significant change in the resident’s physical condition,” which could include “implement[ing] measures to . . . bring the resident’s blood glucose level down to a more normal range”); id. ¶ 70 (“[F]ailure to notify the physician of hyperglycemic incidents also subjected the residents to the risks that the effects of the uncontrolled blood sugars would worsen the residents’ other underlying medical conditions”); P. Ex. 2, at 52 (indicating that blood glucose monitoring may provide opportunities to modify therapeutic regimens and improve metabolic control).

Petitioner contends that certain circumstances surrounding the nursing staff’s errors and omissions demonstrate that they were unlikely to cause serious harm to the residents involved.  RR at 10-11, 28 (asserting that the “context of a[ ] [nursing] error or omission is material to consideration of its seriousness”).  Most notably, Petitioner asserts that a nurse practitioner performed daily rounds in the facility and thus would have noticed any problems or complications resulting from an error or omission by the nursing staff in managing its diabetic residents.  RR at 20 (citing Tr. 209, 214-15).  However, Petitioner cites no evidence that a nurse practitioner’s “rounds” entailed daily visits with each resident or a daily assessment of each resident’s clinical status.  We agree with CMS that “[e]ven if a nurse practitioner was available every day, that does not mean that she made rounds on all the patients every day, as evidenced by the facility’s records.”  Response Br. at 27 n.10 (citing, inter alia, Tr. 61-62).  Petitioner cites no other evidence that prior to the survey, it had robust procedures or systems in place to prevent or identify nursing errors and mitigate potential harm from such errors.

Petitioner contends that CMS imposed, and the ALJ improperly sustained, the immediate jeopardy finding based on “hypothetical” deficiencies, rather than on the noncompliance proved in this case.  RR at 8-9, 11-12, 18.  According to Petitioner, the ALJ “seems to have extrapolated from CMS’s allegations a conclusion that the noncompliance was ‘systemic,’ by which he (allegedly) meant ‘widespread’ or extend[ing] beyond the cited acts or omissions” or reflecting an “unwillingness or inability to follow any physician order.”  RR at 4 (italics in original).  “[W]hen CMS alleges ‘immediate jeopardy’ based upon specific allegations of noncompliance,” says Petitioner, “an ALJ may not – as a matter of law – extrapolate such a determination from other bad things that might happen to some other resident in some other circumstance if some other nurse fails to follow

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some other physician order; in other words, that are not ‘likely’ consequences of the cited noncompliance.”  RR at 11-12.

We reject Petitioner’s suggestion that the ALJ sustained the immediate-jeopardy finding based on hypothetical or unproven deficiencies.  The ALJ merely, and reasonably, surmised that the number, frequency, and recurrence of documented nursing errors or omissions increased the likelihood that a resident – especially a diabetic one – would suffer serious harm if the noncompliance was not corrected.  Furthermore, the ALJ’s characterization of Petitioner’s noncompliance as “systemic” was reasonable given the number, frequency, and recurrence of the nursing errors, and the number of nursing staff involved.   In any event, the ALJ’s finding of systemic noncompliance was neither necessary nor essential to his judgment about the validity of CMS’s immediate-jeopardy finding.  As the Board indicated in its 2018 decision, DAB No. 2913, at 32 n.22, the term “systemic” characterizes a deficiency’s scope, while a finding of immediate jeopardy relates to the deficiency’s severity – that is, the degree and likelihood of the harm threatened by the deficiency.

Petitioner complains that CMS’s witnesses failed to explain “how the cited noncompliance actually found” was likely to cause death or serious harm, “either in general, or with respect to any of the subject residents.”  RR at 3.  According to Petitioner, none of CMS’s witnesses “went beyond general assertions that diabetes is a serious disease,” and so in their view “any error or omission relating to its treatment – even documentation errors – ipso facto could have deadly consequences.”  RR at 5.

We reject this contention because it wrongly presumes that CMS had the burden in this proceeding to prove that the noncompliance was at the immediate-jeopardy level, and because Petitioner does not support its argument with specific examples or citations to the record.  In any event, contrary to Petitioner’s claim, CMS’s witness, Dr. Lesesne, gave reasons for his opinions that went “beyond assertions that diabetes is a serious disease.”  See, e.g., CMS Ex. 29, ¶ 70 (“Moreover, the failure to notify the physician of hyperglycemic incidents also subjected the residents to the risks that the effects of the uncontrolled blood sugars would worsen the residents’ other underlying medical conditions.”).

Finally, Petitioner asserts that the ALJ’s decision on remand sustained CMS’s immediate jeopardy finding on “essentially on the same grounds” as the ALJ’s prior decision.  RR at 1.  This assertion is unsupported by any comparative analysis.  Furthermore, the assertion is plainly inaccurate because the ALJ based the decision on remand on evidence – namely, in-person testimony of the parties’ witnesses – that did not exist when the ALJ issued his initial decision granting summary judgment to CMS.

For the reasons outlined above, we decline to disturb the ALJ’s conclusion that CMS’s immediate-jeopardy finding was not clearly erroneous.

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3. Petitioner alleges no basis to disturb CMS’s finding concerning the duration of the immediate-jeopardy-level noncompliance.

CMS found that Petitioner’s immediate-jeopardy-level noncompliance began on September 15, 2015, and continued through May 12, 2016.  See CMS Ex. 16 (imposing an immediate-jeopardy-level CMP for that period).  Determinations by CMS about when immediate jeopardy to resident health and safety arose, and when it was abated, are reviewed under a clearly erroneous standard.  Vibra Hosp., DAB No. 3094, at 23-24 (stating that the “burden of demonstrating clear error” in CMS’s immediate-jeopardy finding applies to a finding about the “duration of immediate jeopardy”).

Before the ALJ Petitioner raised no objection to CMS’s finding concerning the duration of the immediate-jeopardy-level noncompliance.  See P. Post-Hr’g Br. on Remand.  And it raised no such objection in this appeal.  Because Petitioner has identified no clear error in CMS’s finding concerning the duration of the immediate-jeopardy period, we sustain the finding.

4. Petitioner alleges no basis to disturb the ALJ's finding that $5,900 per day is a reasonable CMP for its period of immediate-jeopardy-level noncompliance.

When a SNF is found noncompliant with one or more participation requirements, an ALJ or the Board may review whether a CMP imposed by CMS is reasonable.  Crawford Healthcare & Rehab., DAB No. 2738, at 18-19 (2016); see also 42 C.F.R. § 488.438(e).  In deciding whether a CMP is reasonable, the ALJ or the Board may consider only the factors specified in 42 C.F.R. § 488.438(f).  See Crawford Healthcare at 19 (citing 42 C.F.R. § 488.438(e)(3)).  Those factors are:  (i) the facility's history of noncompliance; (ii) the facility’s financial condition – that is, its ability to pay the CMP; (iii) the factors specified in 42 C.F.R. § 488.404 (including the “seriousness” of the noncompliance and “the relationship of the one deficiency to other deficiencies resulting in noncompliance”); and (iv) degree of culpability – whether the facility’s noncompliance stems from neglect, indifference, or disregard for resident care, comfort, or safety.  42 C.F.R. §§ 488.438(f), 488.404(a)-(c).

As noted, CMS imposed a $5,900 per day CMP for the period of Petitioner’s immediate-jeopardy-level noncompliance.  The ALJ found the daily penalty amount reasonable based on an assessment of the relevant regulatory factors.  See DAB CR5376, at 12.  Petitioner does not contend that the ALJ’s assessment of the factors is unsupportable, inadequate, or otherwise erroneous.  We therefore sustain his finding that the per-day CMP amount is reasonable.

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5. We deny Petitioner’s July 2, 2024 motion based on Jarkesy.

On July 2, 2024, while this appeal was pending, Petitioner filed a motion asking the Board to “vacate the ALJ’s decision” and “remand the matter to CMS for appropriate disposition” in light of the Supreme Court’s June 27, 2024 decision in S.E.C. v. Jarkesy, 603 U.S. 109 (2024).  Petitioner’s motion also asked the Board to “order CMS to refund the CMP it imposed and collected in this case pending a jury trial (or other CMS action).”  CMS filed a response to Petitioner’s motion on July 12, 2024, and Petitioner submitted a reply on July 29, 2024.

Petitioner contends that Jarkesy “held that where, as here, an agency imposes a CMP for regulatory noncompliance, such a CMP is equivalent to a common law remedy, and thus the Seventh Amendment requires that a jury, not an ALJ, must consider a challenge to that remedy in the first instance.”  Jarkesy Motion at 1.  “Accordingly,” says Petitioner, “this appeal proceeding was void ab initio, and so the Board should,” among other things, “hold that under Jarkesy the ALJ did not have constitutional authority to conduct this review[.]”  Id. at 3; see also Jarkesy Reply at 1 (“[T]his proceeding is void ab initio.”). Petitioner further contends that “if, as Jarkesy holds, the due process necessary in a CMP appeal is a jury trial, then CMS must meet that constitutional command and return the ‘escrowed’ [CMP] funds pending such review.”  Jarkesy Motion at 3.

CMS counters that “the Board consistently has held that ALJs do not have the authority to consider constitutional challenges,” and that Jarkesy does not invalidate those prior decisions or their reasoning that this type of constitutional challenge may not be heard before an ALJ or the DAB.”  Response to Motion at 1.  “Therefore,” says CMS, “there is no authority to remand based on a purported Seventh Amendment infirmity in the long-standing process for review of CMS enforcement actions.”  Id. at 2.  CMS further asserts that Petitioner’s refund request is “premised on the same unreviewable Seventh Amendment claim” and must also be denied for that reason.  Id.

We deny Petitioner’s motion for remand and refund of the CMP based upon Jarkesy.  That case arose from “an enforcement action” by the Securities and Exchange Commission (SEC) pursuant to the Securities Act of 1933, the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, and the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010.  603 U.S. 109, 115-16 (2024).  The SEC brought an enforcement action seeking CMPs from an investment advisor company and its individual manager for alleged securities fraud, and the SEC elected to proceed before an ALJ.  Id. at 115, 117-118.  The Supreme Court addressed the question “whether the Seventh Amendment permits the SEC to compel respondents to defend themselves before the agency rather than before a jury in federal court,” and concluded that “[t]he Seventh Amendment . . . applies and a jury is required.”  Id. at 115, 120-21.

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We reject Petitioner’s attempts to equate this case with Jarkesy.  This case concerns an entirely separate statutory and regulatory regime administered by the U.S. Department of Health and Human Services, an issue that was not even before the Court, which held that the “SEC’s antifraud provisions replicate common law fraud, and it is well established that common law claims must be heard by a jury.”  603 U.S. at 120.  The Court did not hold that every agency’s attempt to impose and enforce CMPs necessarily is, like the SEC’s action, “a common law suit in all but name” that “must be adjudicated in Article III courts.”  Id. at 136.  On the contrary, the Court acknowledged the long-established “public rights exception,” under which “Congress may assign [a] matter for decision to an agency without a jury, consistent with the Seventh Amendment,” and extensively discussed the Court’s precedents applying that exception.  Id. at 127-132.  The Supreme Court did not decide the potential applicability of that exception to the Act and its implementing regulations concerning imposition and enforcement of CMPs for noncompliance with Medicare participation requirements.

As CMS argues, “[t]he Board has consistently held that ALJs may not declare a statute or regulation to be unconstitutional and refuse to apply or follow the statute or regulation on that basis.”  Fady Fayad, M.D., DAB No. 2266, at 14 (2009), aff’d, 803 F. Supp. 2d 699 (E.D. Mich. 2011); see also Borgess Med. Ctr., DAB No. 3106, at 42 (2023); Russell L. Reitz, M.D., DAB No. 2748, at 8 (2016).  The Board is not authorized to invalidate or declare unconstitutional any part of the Act, or its complex implementing regulations, and refuse to enforce it for any reason.  Instead, the Board “must follow applicable statutes and regulations,” and we do so in this case.  See The Oaks, DAB No. 3160, at 28 (2024); Linda Silva, P.A., DAB No. 2966, at 12 (2019).  We cannot anticipate how federal courts may apply the reasoning of Jarkesy in different circumstances, including in the context of the long-standing and complex statutory and regulatory regime governing imposition of CMPs upon SNFs, like Petitioner, that CMS deems noncompliant with the conditions of Medicare participation.  Accordingly, we deny Petitioner’s motion.

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CONCLUSION

For the reasons stated above, we affirm the ALJ’s July 17, 2019 decision and deny Petitioner’s motion for relief based on Jarkesy.