Alvarado LTC Partners, Inc., DAB CR6434 (2024)

DECISION

Petitioner was in violation of 42 C.F.R. § 483.80¹ from about November 16 through December 29, 2020. The regulatory violation posed a risk for more than minimal harm and was noncompliance. The noncompliance posed a risk for immediate jeopardy from November 16 through 22, 2020. 

There is a basis for the imposition of enforcement remedies. A civil money penalty (CMP) of $9,500 per day for the period November 16 through 22, 2020, and a CMP of $250 per day for the period November 23 through December 29, 2020, a total CMP of $75,750, is a reasonable enforcement remedy. A denial of payment for new admissions (DPNA) from December 24 through 29, 2020 is also a reasonable enforcement remedy. 

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I. Background and Procedural History

Petitioner is a skilled nursing facility (SNF) participating in the federal Medicare program and a nursing facility (NF) participating in the Texas Medicaid program. Petitioner is in Alvarado, Texas. Joint Stipulation of Facts (Jt. Stip.). A state surveyor conducted a COVID‑19 focused infection control survey of Petitioner from November 16 through 23, 2020 (November 23 survey). The surveyor concluded that Petitioner was not in substantial compliance with Medicare participation requirements based on a violation of 42 C.F.R. § 483.80 (Tag F880) that posed a risk for more than minimal harm and immediate jeopardy to Petitioner’s residents. The Centers for Medicare & Medicaid Services (CMS) accepted the state agency findings and conclusions. CMS accepted that Petitioner’s noncompliance posed immediate jeopardy to Petitioner’s residents from November 16 through 22, 2020; immediate jeopardy was abated effective November 23, 2022; and Petitioner returned to substantial compliance with Medicare participation requirements effective December 30, 2020. CMS Exhibits (Exs.) 1-2. CMS notified Petitioner by letter dated February 19, 2021, that it was imposing enforcement remedies, including a DPNA from December 24 through 29, 2020, a CMP of $9,500 per day for the period November 16 through 22, 2020, and a CMP of $250 per day for the period November 23 through December 29, 2020. CMS Ex. 1 at 2-3. 

Petitioner timely requested a hearing before an administrative law judge (ALJ) on February 8, 2021 (RFH). Jt. Stip. Petitioner requested review of the allegations of noncompliance, the declaration of immediate jeopardy, and the reasonableness of the enforcement remedies. RFH; Petitioner’s Supplement to Notice of Appeal and Request for Hearing. 

A hearing was convened on March 9, 2022, and a transcript (Tr.) was prepared. CMS offered CMS Exs. 1 through 6, 8, 9, 11, and 12. CMS Exs. 1 through 4, 8, 9, 11 and 12 were admitted as evidence. Tr. 23-40, 117-20. CMS Ex. 2 is the Statement of Deficiencies (SOD) prepared by the surveyor for the survey of Petitioner that was completed on November 23, 2020. The SOD includes many statements of the surveyor described as observations, interviews, and reviews. CMS Ex. 2 at 3-13, 16-19. CMS did not present the testimony of the surveyor at the hearing. Therefore, the surveyor was not present at hearing for cross-examination by Petitioner or examination by me related to what the surveyor recorded in the SOD that the surveyor personally observed, heard during interviews, or how the surveyor interpreted whatever documents the surveyor collected and reviewed. Accordingly, CMS Ex. 2 was admitted as evidence establishing the notice Petitioner received regarding the alleged noncompliance and the allegations of the surveyor regarding her observations, interviews, and collection and review of documents, but not as substantive evidence of what the surveyor observed, heard, or how the surveyor interpreted documents reviewed because she was not subject to cross-examination. CMS

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Ex. 6 includes the notes the surveyor made during the survey. CMS Ex. 6 was not admitted as evidence because the surveyor who made the notes was not available for cross-examination. Tr. 40-62. The surveyor states in the SOD that the surveyor reviewed “Title 40 Social Services and Assistance Part 1 Department of Aging and Disability Services Chapter 19 Nursing Facility Requirements for Licensure and Medicaid Certification Subchapter CC COVID‑19 Emergency Rule § 19.2802.” CMS Ex. 2 at 6, 11, 13. CMS was instructed at hearing to offer a copy of the document referred to by the surveyor as evidence marked as CMS Ex. 13. Tr. 32-33. In “CMS’s Amended (Post-Hearing) Exhibit List,” CMS lists CMS Ex. 13 described as “40 TAC § 19.2802 (Nursing Facility COVID-19 Response).” However, CMS filed no document marked CMS Ex. 13.² 

Petitioner offered P. Exs. 1 through 14. Petitioner’s Exhibits 1, 2, 3,³ 4 (pages 2 and 3), 5, 6, and 8 through 14 were admitted as evidence. Tr. 62-78, 118-20.

CMS called no witnesses. Petitioner called the following witnesses: Tammie Parsons, a certified nurse aide (CNA) employed by Petitioner; Dantrell (Dan) Anderson, Petitioner’s administrator at the time of the survey; and Brandon Kegarise, regional director of operations for Gulf Coast Long-term Care, Petitioner’s owner at the time of the survey. 

On June 30, 2022, CMS and Petitioner filed their post-hearing briefs (CMS Br. and P. Br., respectively). CMS and Petitioner filed post-hearing reply briefs (CMS Reply and P. Reply, respectively) on August 15, 2022.

II. Substantive and Procedural Law

A. Statutory and Regulatory Medicare Program Enforcement

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483. Section 1819(h)(2)

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of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.⁴ The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance. Act § 1819(h)(2)(C). The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory DPNA. Act § 1819(h)(2)(D). The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance. The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction. Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements. 42 C.F.R. §§ 488.400, 488.402(b). “Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301. A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B. 42 C.F.R. § 488.301. The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance, that is, a deficiency that poses a risk for more than minimal harm. 42 C.F.R. § 488.301. Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm. 

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10‑.28, 488.300-.335. The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements. 42 C.F.R. § 488.406. 

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CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements. The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP – $6,808 per day to $22,320 per day – is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.⁵ 42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020). “Immediate jeopardy means 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. The lower range of CMPs – $112 per day to $6,695 per day – is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2020).

The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose an enforcement remedy. Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13). However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a nurse aide training and competency evaluation program (NATCEP). 42 C.F.R. § 498.3(b)(14), (d)(10)(i). In cases in which CMS imposes a CMP, the CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except when the noncompliance allegedly posed immediate jeopardy. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e). 

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B. Burden of Proof, Burden of Production, and Quantum of Evidence

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.” Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted). 

Under the de novo review standard, the ALJ addresses whether the evidence as it is developed before the ALJ supports the finding of noncompliance, not how CMS, or the facility, evaluated the evidence as it stood at whatever time CMS or the facility made their assessments. 

Id. 

The allocation of the burden of proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.⁶ Rather, the Board has long held that the petitioner, i.e., the nongovernmental party, bears the ultimate burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense. Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB

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No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999). 

The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance. If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense. Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007). 

The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing. The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.” Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904. “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.” Black’s Law Dictionary 1228 (8th ed. 2004). One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing; i.e., CMS should be required to present evidence sufficient to establish a disputed fact as more likely true than not and to raise a presumption, subject to being disproved or rebutted. The Board has never specifically ruled that to make a prima facie showing CMS must prove disputed facts by a preponderance of the evidence presented by CMS. Other decisions by various appellate panels of the Board, strongly suggest that whether CMS makes a prima facie showing as to disputed facts with evidence it presents is not really an issue, at least once a petitioner presents some evidence, because an ALJ must consider all the evidence of record to determine whether a prima facie case of noncompliance is shown. The Board has also suggested that CMS might satisfy its initial burden by presenting any relevant evidence even if it amounts to little more than mere allegations or a scintilla of evidence. In its decision in Hillman, following remand, the Board commented that “if a party fails to establish a prima facie case, the opposing party may prevail without producing any evidence. However, it does not follow that, once the opponent has presented evidence, the decision-maker can ignore probative evidence properly in the record before him in weighing whether each party has proven an issue by the preponderance of the evidence.” Hillman Rehab. Ctr., DAB No. 1663 (1998 WL 479289 at 5). One may interpret the Board’s statement to indicate that CMS needs to make its prima facie showing by a preponderance of the evidence. However, even if that was the Board’s position in Hillman, the Board also indicates that once a petitioner presents evidence, the issue of whether CMS has made a prima facie showing is of no consequence if the opponent’s

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evidence shows noncompliance. In St. Joseph Villa Nursing Ctr., DAB No. 2210 (2008), the Board cited its reasoning from Hillman and stated that “the legal sufficiency of CMS’s case does not depend solely upon the evidence submitted by CMS itself.” DAB No. 2210 at 3. Therefore, it is possible given the Board’s reasoning, that CMS might not present sufficient evidence to establish a prima facie case of noncompliance, but Petitioner’s evidence could cure the defect.⁷ One might thus conclude that CMS need not present any evidence, or CMS may present mere allegations or a scintilla of evidence, and the burden of persuasion would nevertheless be upon a Petitioner to prove it was in substantial compliance. This issue is present in most all contested cases but more clearly in this case because CMS did not call the surveyor to testify, which caused a limitation on consideration of the allegations of the SOD to remedy the infringement upon Petitioner’s right to cross-examine the surveyor. 

Petitioner argues that CMS could not make a prima facie showing in this case based on the limited evidence CMS presented. P. Br. at 2-4. Contrary to the arguments of Petitioner, I conclude based on the rationale expressed by the Board in its decisions that CMS made its prima facie showing of noncompliance in this case based on the undisputed facts and Petitioner’s admitted evidence.⁸ Therefore, the burden of persuasion is properly upon Petitioner to show by a preponderance of the evidence that it was in substantial compliance with program participation requirements. I conclude that Petitioner did not meet its burden. 

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C. Issues

Whether there is a basis for the imposition of enforcement remedies;

Whether the declaration of immediate jeopardy was clearly erroneous; and

Whether the remedies proposed are reasonable.

III. Findings of Fact, Conclusions of Law, and Analysis

The survey of Petitioner involved in this case was completed on November 23, 2020. The surveyor recorded her findings and conclusions with her observations, interviews, and records review in the SOD (CMS Ex. 2). The surveyor gave Petitioner notice that Petitioner violated the participation requirements established by 42 C.F.R. § 483.80(a) (specifically subsections (1), (2), and (4)), and subsections (e), and (f). CMS Ex. 2 at 1. Only 42 C.F.R. § 483.80 and subsections (a) and (f) of the regulation are at issue in this case. The general overarching requirement of 42 C.F.R. § 483.80 is that Petitioner must “establish” and “maintain” an infection prevention and control program (IPCP) with the goals of providing its residents “a safe, sanitary, and comfortable environment” that helps “prevent the development and transmission of communicable diseases and infections.” 42 C.F.R. § 483.80. The regulation requires implicitly that Petitioner implement, i.e., follow, its IPCP to accomplish the objectives specified by the regulation. Golden Living Ctr. – Superior, DAB No. 2768 at 7 (2017). The requirements of 42 C.F.R. § 483.80(a) are that Petitioner establish an IPCP with the four elements specified. Petitioner is required to review its IPCP annually and to update its IPCP as necessary by 42 C.F.R. § 483.80(f). The handling, storing, processing, and transporting of linens to prevent spreading infection is covered by 42 C.F.R. § 483.80(e). CMS does not proceed on a theory that Petitioner failed to properly handle linens and the alleged violation of 42 C.F.R. § 483.80(e) receives no further consideration. 

The surveyor cited three examples as the bases for finding Petitioner was in violation of the regulation: (a) Petitioner failed to screen employees entering the facility; (b) Petitioner failed to ensure staff wore proper personal protective equipment (PPE) when caring for positive and negative COVID-19 residents and while monitoring residents in the smoking area; and (c) Petitioner failed to ensure the safety of Residents 1 and 2 who tested negative for COVID-19 but continued to live among residents who tested positive for COVID-19. CMS Ex. 2 at 3 to 4. The surveyor alleged that the violations posed a risk for more than minimal harm and immediate jeopardy beginning about November 16, 2020, and immediate jeopardy was removed on November 23, 2020. CMS Ex. 2 at 4. 

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During the hearing, CMS advised me that it was not proceeding on the surveyor allegations related to smoke breaks or screening employees, and I give no further consideration to those examples. Tr. 100-03, 105. CMS made clear at the hearing that its focus in this case is the care, treatment, and safety of Residents 1 and 2. Tr. 105-07. The surveyor’s allegation that Petitioner failed to ensure the safety of Residents 1 and 2 when they were the only COVID-19 negative residents remaining at Petitioner is broad. Petitioner is required by 42 C.F.R. § 483.80 to provide its residents a safe environment by protecting residents from the development and transmission of communicable diseases and infections through the creation and implementation of an IPCP. Petitioner’s failure to follow its IPCP and review and revise its IPCP to address the new circumstances of Residents 1 and 2 remaining at Petitioner while all other COVID-19 negative residents were transferred fits within the scope of the surveyor’s allegation that Petitioner did not ensure the residents’ safety. 

CMS proceeds in this case upon two theories for why Petitioner was noncompliant with the program participation requirement established by 42 C.F.R. § 483.80. The alleged violation of 42 C.F.R. § 483.80(a), is not based on Petitioner not having a written IPCP. Rather, the allegations are that Petitioner failed to implement or follow its IPCP and failed to update its IPCP when all but two COVID-19 negative residents were transferred to other facilities, leaving only those two COVID-19 negative residents residing with multiple positive residents. CMS Ex. 2 at 3; Tr. 106; CMS Br. at 15-17; CMS Reply at 9-11. In its post-hearing brief, CMS argues that after the transfer of all but two COVID-19 negative residents, Petitioner’s management and staff considered Petitioner to be 100 percent COVID-19 positive and simply stopped following many provisions of it COVID-19 IPCP. CMS further refined its argument asserting: 

Although [Petitioner] had developed policies for dealing with COVID-19 and amended those policies on multiple occasions, it failed to amend its written policies when the facility-wide outbreak began in late-October 2020. Rather, it stumbled forward on inadequate, ad hoc, unwritten procedures that put the two COVID-negative residents at risk.

By November 16, 2020, [Petitioner] had abandoned the isolation protocols, cohorting, and dedicated staffing policies in its written COVID policies.  It transferred a majority of its COVID negative patients to sister facilities and declared its entire facility a COVID-only facility.  But it wasn’t.

CMS Br. at 1-2. CMS makes the point that when Petitioner transferred all COVID-19 negative residents except Resident 1 and 2, and Resident 1’s and 2’s representatives

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signed consent forms, Residents 1 and 2 were not covered by any written IPCP.⁹ CMS Br. at 2, 11-17; CMS Reply at 1-2, 4-11. 

I conclude that the undisputed evidence shows that Petitioner stopped following its existing COVID-19 IPCP and did not consider or adopt a new or revised IPCP when all but two COVID-19 negative residents were transferred. The CMS argument was clearly stated in the CMS post-hearing brief. Resolution on the theory advanced by CMS turns on application of the law to the undisputed facts. Petitioner had the opportunity to respond to the refined CMS argument in its post-hearing reply brief, which is one of the purposes of permitting the parties to file replies. The fact Petitioner may have been surprised that CMS made such a refined argument is not prejudice that requires any remedy, so long as, Petitioner had the opportunity to address the argument in its reply brief. 

A. Findings of Fact

Each of my factual findings are undisputed or based on the preponderance of the evidence. I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision. I discuss the credible evidence given the greatest weight in my decision-making.¹⁰ I also discuss any evidence that I find is not credible or worthy of weight. The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ. There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so. Charles H. Koch, Jr., Admin. L. & Prac. § 5:64 (3d ed. 2013). 

1. There is no dispute that until about November 7, 2020, Petitioner had developed and maintained, i.e., implemented, an IPCP that was revised on April 20 and July 21, 2020. P. Ex. 3.

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2. Petitioner was not cited by state agency surveyors during their visits on October 31 through November 5, 2020, and on November 16, 2020, for violation of 42 C.F.R. § 483.80 or any other Medicare participation requirement under 42 C.F.R. pt. 483. P. Ex. 2 at 1-3.

Petitioner provided for my consideration a part of its IPCP titled “COVID 19 Policy and Procedures Updates” that reflects that it was revised on April 20, 2020, and July 21, 2020. P. Ex. 3 at 1, 4 (document page counter). P. Ex. 3 is clearly not Petitioner’s complete IPCP because it is only five pages long and covers only COVID-19 policy and procedures. 

CMS did not offer as evidence any portion of Petitioner’s IPCP obtained by the surveyor during the survey. Surveyor notes offered by CMS as CMS Ex. 6 (not admitted) show that the surveyor considered a document similar to P. Ex. 3 and another policy dated August 28, 2020 related to “testing” for residents and staff. CMS Ex. 6 at 4 (not admitted).¹¹ Because the surveyor did not testify at hearing, it is not possible to determine whether the surveyor obtained copies of the parts of IPCP she reviewed or whether she obtained and reviewed any part of Petitioner’s IPCP other than that included in P. Ex. 3. 

Because Petitioner placed in evidence only a portion of its IPCP (P. Ex. 3), I infer that Petitioner’s opinion is that P. Ex. 3 is the only part of its IPCP that is material to the issues I must decide. Following are some significant points from Petitioner’s COVID-19 IPCP as revised on April 20, 2020: 

Required that all residents be monitored for symptoms of COVID-19 and that those who were ill be monitored for changes in temperature and oxygen saturation that might require transfer to a higher level of care.

Required that all staff use PPE when interacting with residents, without specifying whether COVID-19 positive or negative, to the extent that PPE was available.

Required that staff wear a face mask and appropriate PPE while in the facility subject to availability.  P. Ex. 3 at 1 (document page counter).

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Required that staff wear full PPE according to Centers for Disease Control and Prevention (CDC) guidelines when caring for a resident known or suspected to be infected with COVID-19. P. Ex. 3 at 2 (document page counter).

If any COVID-19 transmission occurred in the facility, healthcare staff were required to wear full PPE for caring for all residents according to CMS guidelines and all residents were to be restricted to their rooms.

Residents and their representatives were to be notified within 12 hours of the confirmation of a single COVID-19 case or if three or more residents or staff had new onset respiratory symptoms within a three-day period. P. Ex. 3 at 2 (document page counter).

Training for staff was required in the use of PPE, particularly the face mask. P. Ex. 3 at 3 (document page counter).

Extended use of face masks was permitted, except in the case of a resident on isolation.

COVID-19 positive patients were to have consistent staffing by all means possible and be placed on designated COVID-19 halls or areas as necessary to facilitate containment.  P. Ex. 3 at 4.

Petitioner’s policy was changed effective July 21, 2020. The policy as modified required that COVID-19 positive residents be isolated: 

Until they had no fever without the use of medication;

They had improved respiratory symptoms; and

They had two negative COVID-19 tests conducted more than 24 hours apart.

P. Ex. 3 at 4.

Petitioner’s COVID-19 IPCP does not address or permit treating COVID-19 negative residents as if they are infected.

The references in Petitioner’s IPCP to CDC and CMS guidelines show that Petitioner accepted those guidelines as standards of care to be followed in Petitioner’s facility. We have in this case evidence of standards of practice related to COVID-19 adopted or recommended by the State of Texas, CMS, and the CDC. P. Ex. 1; CMS Ex. 8, 9, 11, 12.

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The standards of practice recommended by the state and federal government do not address or recommend treating COVID-19 negative residents as being infected. 

I infer that Petitioner had no further revision of its COVID-19 IPCP between July 21, 2020, and the end of the survey on November 23, 2020, because Petitioner did not offer a revised IPCP as evidence. 

Whether Petitioner’s IPCP related to COVID-19, last revised on July 21, 2020, was adequate to accomplish the goals of 42 C.F.R. § 483.80 prior to the transfer of all but two COVID-19 negative residents around November 7, 2020, is not at issue. What is at issue is whether Petitioner stopped following its IPCP last revised July 21, 2020, determined whether its IPCP was adequate to protect Residents 1 and 2 from COVID-19 when they became the only COVID-19 negative residents at Petitioner on about November 7, 2020, and revised its IPCP as necessary to protect those residents. Surveyor notes from the November 23 survey regarding Petitioner’s implementation of its plan of removal of immediate jeopardy do not show that the surveyor required any change in Petitioner’s IPCP for the surveyor to find that the immediate jeopardy was abated. The surveyor’s discussion of the plan of removal mentions that staff were taught to take off PPE when caring for COVID-19 negative residents, but that is the only mention of caring for COVID-19 negative residents. The surveyor notes describe in considerable detail staff training and observations of staff practicing infection control. The surveyor notes do not show that any change to Petitioner’s IPCP was required to abate immediate jeopardy. CMS Ex. 6 at 11 (not admitted). The surveyor does not mention a written revision of Petitioner’s IPCP as a corrective action that caused her to conclude immediate jeopardy was abated. CMS points to no written revision of the IPCP that the surveyor required to abate immediate jeopardy. Revision of Petitioner’s COVID-19 IPCP may not have been a consideration for the surveyor or required to find immediate jeopardy was abated. However, the CMS position is that noncompliance existed because Petitioner stopped following its COVID‑19 IPCP and failed to revise its COVID-19 IPCP when Residents 1 and 2 were permitted to continue to reside at Petitioner when all other COVID-19 negative residents were transferred on about November 7, 2020. 

3. It is not disputed that Petitioner had 45 residents when the survey was completed on November 23, 2020. CMS Ex. 2 at 1.

4. It is not disputed that on or about November 7, 2020, Petitioner transferred all COVID-19 negative residents to other long-term care facilities except two – Residents 1 and 2 – who were both COVID-19 negative and continued to reside at Petitioner with COVID-19 positive residents.

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5. It is not disputed that Petitioner made no changes to the part of its IPCP related to COVID-19 (P. Ex. 3) between about July 2020 and completion of the survey on November 23, 2020.

6. Petitioner has not presented evidence that its infection preventionist,¹² quality assessment and assurance committee, medical director, or others met to develop and implement written changes to Petitioner’s IPCP when all but two COVID-19 negative residents were transferred to other facilities on about November 7, 2020.

7. It is not disputed that after November 7, 2020, when all but two COVID-19 negative residents were transferred, Petitioner no longer maintained separate halls for COVID-19 positive residents with dedicated staff to facilitate containment, contrary to the requirement of its COVID-19 IPCP. P. Ex. 3 at 4; Tr. 126-34, 165-67, 186-89, 195-96, 198-99, 231-33, 251, 239-40.

Petitioner presented the testimony of its administrator, the regional director for Petitioner’s owner, and one of its CNAs. Their testimony is credible and supports my findings that Petitioner took no action to develop and implement written changes to Petitioner’s IPCP when Petitioner transferred all but two COVID-19 negative residents to other facilities. The testimony also highlights that there was a need for written changes and implementation of those changes. 

Petitioner’s administrator, Dantrell L. Anderson, was called to testify by Petitioner. Administrator Anderson testified that he has been Petitioner’s administrator since March 2019. Tr. 157. He testified that at the time of the survey that ended on November 23, 2020, Petitioner had only two residents who were COVID-19 negative. He testified that when the COVID-19 outbreak occurred at Petitioner it was not possible to place the two COVID-19 negative residents – Residents 1 and 2 – in a wing by themselves due to staffing shortage, and there was no other secured hallway where they could be housed.

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Residents 1 and 2 required a secure hallway because they suffered from dementia, and they were at risk for exiting the facility. It was also not possible to place Residents 1 and 2 in a room together as one was male and the other female. He testified that Petitioner had a sister facility with no COVID-19 positive residents to which Residents 1 and 2 could have been moved. However, the representatives of Residents 1 and 2 came to the facility and signed informed consent forms indicating that the representatives did not want the two residents moved to a different facility (P. Ex. 11). The representatives of Residents 1 and 2 were informed that if Residents 1 and 2 remained at the facility, they would be treated like the other residents, i.e., as if they were COVID-19 positive.¹³ Tr. 165-67, 186-88. He testified that 28 to 30 other residents who were COVID-19 negative were relocated to other facilities when the number of COVID-19 positive cases began increasing at Petitioner. However, the representatives of Residents 1 and 2 did not want those residents moved to another facility even though he explained that Petitioner intended to become a 100 percent COVID-19 positive facility and the risks of that change to Residents 1 and 2. Tr. 174-75.

Administrator Anderson testified that staff was not required to change PPE whenever they went from one resident’s room to another, unless the gown, for example, was torn or soiled. Residents 1 and 2 were in individual rooms with no roommate and their doors remained closed. Tr. 188-89. In response to my questions, Administrator Anderson testified that they transferred all the COVID-19 negative residents that would go, and the entire facility was treated as being COVID-19 positive with all residents being treated as if they were in isolation. Even though Residents 1 and 2 were COVID-19 negative, their representatives consented to them being treated by nurses and certified nurse assistants (CNAs) who were also treating COVID-19 positive residents. Tr. 195-96. Administrator Anderson explained, for example, that because Residents 1 and 2 were in an area that had COVID-19 positive residents, staff were required to wear N95 masks and full PPE when caring for those residents even in their individual rooms. Tr. 198-99. 

On cross-examination, Administrator Anderson explained that Petitioner’s COVID-19 policy and procedure (P. Ex. 3) was provided by the “regional leader” responsible for Petitioner and six other facilities and was implemented the best way that Petitioner’s staff could. Tr. 200. Petitioner had other infection control policies and procedures prior to COVID-19, and the COVID-19 policies and procedures in P. Ex. 3 were received from

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the regional office early in the pandemic. Tr. 201. Administrator Anderson testified that Resident 1’s and 2’s representatives signed the forms consenting to the residents remaining at Petitioner on November 7, 2020, and he recalled that is when COVID-19 negative residents were being evacuated. He agreed that about that time Petitioner’s census went from 73 to about 50, that 47 residents contracted COVID-19, and 76 staff were reported to have contracted COVID-19 by November 15, 2020. He estimated that staff numbered between 65 and 70 during that period. Tr. 202-04. He testified that staff was being educated the same as before the survey regarding COVID-19 through November 23, 2020, the date the immediate jeopardy was determined to have been abated. Tr. 206. 

In response to my questioning, Administrator Anderson, explained the sequence of surveyor visits during a period of approximately four weeks. Surveyor Hayes visited Petitioner when Administrator Anderson reported the first case of COVID-19 to the state, which he believed was the practice of the state survey agency. The first case involved a resident who was sent to the hospital and returned to Petitioner COVID-19 positive. He understood that Surveyor Hayes came to examine how Petitioner was handling COVID-19 and found no deficiencies with Petitioner’s infection control. However, about a week or two later, when Petitioner had more COVID-19 positive cases, Surveyor Hayes returned and was then joined by Surveyor Lain, and he understood that they found no deficiency after two days at Petitioner. Surveyors Hayes and Lain departed and a couple of days later Surveyor Purple arrived at Petitioner. When Surveyor Purple arrived at Petitioner, nearly 100 percent of Petitioner’s residents were infected with COVID-19. Tr. 206-11. P. Ex. 2 shows that Surveyor Hayes was at Petitioner from October 31 to November 5, 2020, and found no basis for citing Petitioner related to infection control. P. Ex. 2 at 2. Surveyor Lain was at Petitioner on November 16, 2020, and she also cited no deficiencies. P. Ex. 2 at 3. 

Administrator Anderson did not testify that there was a recognized need or an effort to amend Petitioner’s IPCP related to COVID-19 between July 2020 and the survey in November 2020. 

Brandon Kegarise was called to testify by Petitioner. During 2020, he worked as regional director for operations for Gulf Coast Long-term Care, which is the company that owned Petitioner. Tr. 225, 227; P. Ex. 14. He was responsible for overseeing the operations of six facilities. Tr. 227. He was involved as a member of a regional team in developing the COVID-19 policies and procedures for Gulf Coast to be implemented by Petitioner and other facilities he oversaw. Tr. 228. He had a weekly video call with the administrators and directors for nursing for his facilities to review updates to the Texas COVID-19 response plan. Tr. 229. He and his regional director of clinical services traveled to Petitioner to assess the situation and assist when Petitioner was at the height of the COVID-19 outbreak. Initially, Petitioner’s A Hall was designated a COVID-19

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unit with dedicated staff who only worked on that unit. However, as cases began to increase it was necessary to designate Petitioner’s B Hall a COVID-19 unit, also with dedicated staff. He testified that dedicated staff was required by Texas Health and Human Services because dedicated staff from the A Hall could not cross the COVID-19 negative zone between the two halls.¹⁴ Symptomatic COVID-19 positive staff were to quarantine at home. Asymptomatic but COVID-19 positive staff were permitted to work with COVID-19 positive residents. As the number of COVID-19 positive residents increased, Petitioner did not have enough COVID-19 negative staff to care for residents on Petitioner’s secure units. Mr. Kegarise testified that he discussed the situation with the chief executive officer for Gulf Coast and the decision was made to transfer COVID-19 negative residents to sister facilities if families consented to the transfer. Mr. Kegarise coordinated the transfers to the facilities within his region. Tr. 231-33, 251. He testified that when Surveyor Hayes was at the facility around October 31, 2020, two of Petitioner’s halls were designated for COVID-19 positive residents. The evacuation of COVID-19 negative residents did not occur until November 7, 2020, prior to the return of a surveyor on November 16, 2020. Tr. 234-36. After evacuation of other COVID-19 negative residents, Resident 1 and Resident 2 remained, and one resided on the male, secure hall and the other on the female, secure hall with COVID-19 positive residents. Petitioner had no other secure hall that could be designated a COVID-19 negative hall for Residents 1 and 2 and they could not be housed together safely because both were demented with exit seeking behavior, and one was male and the other female. Tr. 239-40. 

In response to my questions, Mr. Kegarise declined to opine whether under federal regulations Petitioner could have transferred Residents 1 and 2 to a different facility where their risk of contracting COVID-19 was less, despite the wishes of family that the two residents remain at Petitioner. Petitioner deferred to the wishes of the two families recognizing that transferring a resident with dementia can have an adverse psychological impact on the resident.¹⁵ Tr. 240-45. Mr. Kegarise testified that involuntary transfer was never discussed. Tr. 259. 

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Mr. Kegarise did not testify that there was a recognized need or any effort to amend Petitioner’s IPCP related to COVID-19 between July 2020 and the survey that ended on November 23, 2020. 

Petitioner presented the testimony of CNA Tammie Parsons. Tr. 121-23. She testified that she worked the women’s dementia unit, which around the time of the survey that ended on November 23, 2020, had only three residents as COVID-19 negative residents had been moved from Petitioner. Resident 2 was the only COVID-19 negative resident on the unit. She worked the 6:00 a.m. to 6:00 p.m. shift and delivered all three meals to the three residents on the unit. Each of the three residents was assigned a room with no roommate and a resident was not permitted to enter another resident’s room. She testified that she was the only CNA that worked the shift. She testified that she wore full, clean PPE (gown, mask, and shield) when delivering meal trays and delivered a meal to Resident 2 first. She then delivered meal trays to the two COVID-19 positive residents and assisted one with feeding. She did not have to assist Resident 2 with transferring or eating and maintained a distance of six feet from Resident 2. When she entered Resident 2’s room she first went into the resident’s bathroom and washed her hands and then donned gloves. There was no hand sanitizer on the unit because the residents suffered from dementia and might attempt to ingest the sanitizer. She testified that after she deposited the tray in Resident 2’s room she removed her gloves and again washed her hands. Tr. 126-34. 

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CNA Parsons testified that she could use the same gown and masks with multiple patients so long as they were not soiled. If a gown or mask became soiled, it was replaced with a clean gown or mask. Tr. 136. She testified that on November 20, 2020, the surveyor saw her enter Resident 2’s room without changing her PPE. She testified while the surveyor observed correctly, it was not company policy at the time to change PPE between rooms and the COVID-19 negative residents and Resident 1’s and Resident 2’s responsible parties knew that Petitioner was treating the facility as having only COVID-19 positive residents. Tr. 143, 151-52; P. Ex. 10 at 2. CNA Parsons stated in her written statement that responsible parties signed waivers so that Residents 1 and 2 could be treated the same as COVID-19 positive residents, i.e., as if Residents 1 and 2 were COVID-19 positive. P. Ex. 10 at 2. She testified that before delivering meal trays she might have changed a resident who had soiled themselves, but she would only change her PPE (gown, shield, and mask) if visibly soiled. Tr. 144-45. In response to my questions, she testified that she would be within about three feet of Resident 2 when delivering her meal tray and the resident would not be wearing a mask. The COVID-19 positive residents only wore a mask if they were wandering outside their room, but they did not wonder because they were sick. Tr. 146-47, 149.

The testimony of Petitioner’s three witnesses is fully credible. The testimony of Administrator Anderson and Mr. Kegarise establishes by a preponderance of the evidence that Petitioner did not update its IPCP between July 20, 2020, and the survey that ended on November 23, 2020, despite the fact Petitioner’s management decided that Petitioner’s residents would be treated as if all were COVID-19 positive and then transferred all but two COVID-19 negative residents to other facilities. The testimony of CNA Parsons shows that it was left to her judgment which were the best infection control precautions to employ to protect Resident 2 from being infected with COVID-19. CNA Parsons testimony also shows that because of the consent document signed by Resident 2’s representative or family, CNA Parsons was under the impression that Resident 2 could be treated as if she was COVID-19 positive. Petitioner offered no testimony as to the precautions employed for Resident 1, but I have no cause to find he was treated differently. 

B. Conclusions of Law and Analysis

1. Petitioner violated the general requirement of 42 C.F.R. § 483.80 to develop and implement an IPCP to “help prevent the development and transmission” of COVID-19.

2. Petitioner violated the specific requirement of 42 C.F.R. § 483.80(f) to update its IPCP as necessary.

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3. Petitioner’s regulatory violations posed a risk for more than minimal harm to two residents – Residents 1 and 2. 

The regulation requires that Petitioner establish and maintain an IPCP. The regulation requires that Petitioner’s IPCP be designed to provide residents a “safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.” 42 C.F.R. § 483.80. When the survey occurred, Petitioner had mostly residents who had COVID-19. However, Petitioner also had two residents – Residents 1 and 2 – who did not have COVID-19. The regulation clearly establishes Petitioner’s obligation to have an IPCP that helped prevent the transmission of COVID-19 to Residents 1 and 2. Petitioner cites no authority for the proposition that Petitioner could relieve itself of the regulatory obligation by obtaining signed consent forms (P. Ex. 11 at 1, 3) from the residents’ representatives. Petitioner also presents no evidence to dispute that the risk for infection with COVID-19 is a risk for more than minimal harm. 

Under 42 C.F.R. § 483.80(a)(1), Petitioner’s IPCP must be consistent with national standards, at least some of which are in evidence. The Secretary and CMS do not dictate the national standards applicable.¹⁶ CMS specifically decided not to incorporate CDC guidelines by reference in the infection control regulation at 42 C.F.R. § 483.80, stating: 

We believe that facilities need the flexibility to determine which national standard they are going to follow. We also believe it is appropriate for the different types of national standards that are acceptable to CMS to be included in the sub-regulatory guidance for this rule. Although we are not requiring that LTC facilities follow the CDC guidelines,

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we agree with the commenters that the CDC is an excellent resource for guidelines, as well as other information on infection control, and encourage LTC facilities to consider the CDC guidelines.

81 Fed. Reg. 68,688, 68,808 (Oct. 4, 2016). CDC guidelines do not have the force and effect of law because they are not promulgated as regulations. Cf. Azar v. Allina Health Servs., 588 U.S. __, 139 S. Ct. 1804 (2019). Rather, CDC guidelines are evidence of a standard of practice that CMS has found acceptable. CMS gives long-term care facilities significant discretion to determine how to best address infections within the facility consistent with national standards. 

Petitioner revised its COVID-19 infection control policy last on July 20, 2020. Whether the revised policy met national standards from July 20 to November 7, 2020, or was adequately implemented during that period are not issues before me. However, the situation at Petitioner changed dramatically on or about November 7, 2020, when the decision was made to transfer all COVID-19 negative residents to other facilities and treat Petitioner’s residents as if 100 percent of its residents were COVID-19 positive. At that time, Petitioner also stopped segregating COVID-19 positive residents and providing them dedicated staff. Residents 1 and 2 were both COVID-19 negative at the time of that decision, but Petitioner permitted them to remain at its facility. Petitioner’s regulatory obligation under 42 C.F.R. § 483.80 to protect those two residents from COVID-19 infection continued, despite any consent forms signed by the residents or their representatives. But the evidence shows that Petitioner’s management failed to adopt any plan to protect Residents 1 and 2. Rather, Petitioner elected to treat the two residents the same as the COVID-19 positive residents who were not transferred. Petitioner left the decision of appropriate interventions to protect Residents 1 and 2 to staff who rendered care, such as CNA Parsons. 

Petitioner argues that CMS has failed to make a prima facie case, largely because CMS failed to present the testimony of Surveyor Purple who cited the noncompliance based on the survey that ended November 23, 2020, and declared immediate jeopardy. P. Br. at 2‑4. I reject Petitioner’s argument finding and concluding that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.80 that posed a risk for more than minimal harm based on the undisputed facts and evidence presented by Petitioner. I conclude that Petitioner has failed to rebut the CMS prima facie showing of noncompliance and show that it remained in substantial compliance. Petitioner’s failure to review and revise its IPCP as necessary violated the general regulatory requirement of 42 C.F.R. § 483.80 to provide Residents 1 and 2 a “safe sanitary, and comfortable environment” and to prevent the spread of the COVID-19 infection to them. Petitioner’s inaction also violated the specific requirement of 42 C.F.R. § 483.80(f) to amend its IPCP as necessary. Amendment of Petitioner’s IPCP was necessary due to the changed

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circumstances and the fact that, despite the changed circumstances, Petitioner remained responsible to protect Residents 1 and 2 from COVID-19 infection and failed to have a plan to do so. 

Petitioner argues that there were two surveys in November 2020, before Surveyor Purple arrived at Petitioner and cited Petitioner for noncompliance under 42 C.F.R. § 483.80 that posed immediate jeopardy. Petitioner assumes there was no error related to the first two surveyor visits and argues that Surveyor Purple was in error in her findings and conclusions because she was not thorough or accurate in conducting the survey based, in part, on the fact she was only at Petitioner for 20 minutes before declaring immediate jeopardy. Petitioner also suggests that Surveyor Purple may have been improperly motivated. P. Br. at 7-9; P. Reply at 2, 7-8. P. Ex. 2 shows that Surveyor Hayes was at Petitioner from October 31 to November 5, 2020, and found no basis for citing Petitioner related to infection control. P. Ex. 2 at 2. Surveyor Lain was at Petitioner on November 16, 2020, and she also cited no deficiencies. P. Ex. 2 at 3. Administrator Anderson testified that Surveyor Hayes visited Petitioner when Petitioner reported the first case of COVID-19 to the state. He understood that Surveyor Hayes came to examine how Petitioner was handling COVID-19 and found no deficiencies with Petitioner’s infection control. Surveyor Hayes returned joined by Surveyor Lain when Petitioner had more COVID-19 positive residents. They found no deficiency after two days at Petitioner. When Surveyor Purple arrived at Petitioner, nearly 100 percent of Petitioner’s residents were infected with COVID-19. Tr. 206-11. The Board has repeatedly held that real or perceived flaws in the survey process, even surveyor bias, are immaterial when the objective evidence, such as the facility’s own records, establish noncompliance. The ALJ’s de novo review corrects any flaw in the surveyor’s evaluation of the evidence. Jewish Home of E. Pa., DAB No 2254 at 14-15 (2009). The Board has also concluded that “the ultimate issue before an ALJ is . . . ‘whether the evidence as it is developed before the ALJ supports’ CMS’s independent ‘finding of noncompliance’ under the relevant participation requirements.” Avon Nursing Home, DAB No. 2830 at 11 (2017) (citing Sunshine Haven Lordsburg, DAB No. 2456 at 21 (2012), aff’d in part and transferred, Sunshine Haven Lordsburg v. U.S. Dept. of Health & Human Servs., 742 F.3d 1239 (10th Cir. 2014)). Therefore, the Board’s decisions require that I focus on the CMS bases for finding noncompliance (not the surveyor’s) and whether the evidence before me (not the evidence before the surveyor) supports the CMS citation of noncompliance. Based on the Board’s decisions, whether errors were committed by surveyors or whether one survey team was correct, and another was not, are simply not material. The issue before me is whether the undisputed facts and objective evidence supports the position urged by CMS that there was noncompliance. I have concluded that the evidence of record shows Petitioner was not in substantial compliance with program participation requirements. Accordingly, I conclude that Petitioner’s arguments about how the survey was conducted, and the possible motives of Surveyor Purple are without merit. 

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Petitioner argues that it would not have been safe to transfer Residents 1 and 2 because of their dementia. Even if I accept this assertion as true, it does not rebut the fact that Petitioner stopped following its IPCP on about November 7, 2020, and failed to review and revise its IPCP due to the changed circumstances at Petitioner. Petitioner further argues that it did the best it could considering the pandemic. Petitioner presented evidence showing its various efforts to follow national standards related to COVID-19 to keep its residents safe. I appreciate the dire circumstances the COVID-19 pandemic created in long-term care facilities. However, those circumstances do not justify Petitioner’s failure to protect its residents by ensuring its IPCP was implemented and its IPCP was revised as necessary. The pandemic is not an excuse for Petitioner’s failure to ensure it developed and implemented an IPCP that protected Residents 1 and 2 from COVID-19 infection. 

Petitioner argues that CMS should be estopped from finding noncompliance and imposing enforcement remedies because Petitioner acted based on state guidance and the two surveys earlier in November 2020 found no noncompliance with infection control requirements. P. Br. at 16-17. Petitioner’s argument is construed to be for application of equitable estoppel, which if available at all, is available only in cases where the non-federal party shows both “‘that the traditional requirements for estoppel are present (i.e., a factual misrepresentation by the government, reasonable reliance on the misrepresentation by the party seeking estoppel, and harm or detriment to that party as a result of the reliance) and that the government’s employees or agents engaged in ‘affirmative misconduct.’” Southlake Emergency Care Ctr., DAB No. 2402 at 8 (2011) (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 31 (2011)). Petitioner’s noncompliance occurred when it stopped following its existing IPCP on about November 7, 2020, and failed to review and revise its IPCP to provide for the safety and protection of Residents 1 and 2 from infection with COVID-19. Although, the two surveys concluded on November 5 and 16, 2020 (P. Ex. 2 at 2-3) found no noncompliance, Petitioner points to no evidence that the surveyors involved in those surveys informed Petitioner it was not necessary to continue to follow its existing IPCP or to review and revise its IPCP based on the changed circumstances at Petitioner. Petitioner points to no evidence that those surveyors even considered the specific bases CMS cites for noncompliance. Petitioner points to no evidence that the State of Texas gave instructions to long-term care facilities that Petitioner relied upon to justify not following its IPCP or reviewing and revising its IPCP on about November 7, 2020. Petitioner has failed to demonstrate that it reasonably relied to its detriment on any alleged misrepresentations by surveyors, the state agency, or that there was any affirmative misconduct by any government employees or agents. 

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Finally, in its request for relief from the sanctions imposed by CMS, Petitioner raises arguments that could construed to request equitable relief. P. Br.; P. Reply. I do not have authority to provide equitable relief. See US Ultrasound, DAB No. 2302 at 8 (2010). 

4. Petitioner has not met its burden to show that the declaration of immediate jeopardy for the period November 16 through 23, 2020, due to the noncompliance under 42 C.F.R. § 483.80 (Tag F880), was clearly erroneous.

The surveyor and CMS determined that Petitioner’s noncompliance amounted to immediate jeopardy from November 16 through 22, 2020. There is no dispute that the surveyor found that immediate jeopardy was abated on November 23, 2020, and CMS agreed with that determination. Petitioner bears the heavy burden to show that the determination that Petitioner’s noncompliance under 42 C.F.R. § 483.80 posed immediate jeopardy from November 16 through 22, 2020, was clearly erroneous. 

Immediate jeopardy is “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, 489.3 (emphasis added). In the context of survey, certification, and enforcement related to SNFs and NFs, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy. 42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), (d). The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management. 42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii). 

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate jeopardy to the health or safety of a facility’s residents is not an initial determination that triggers a right to request a hearing by an ALJ or that is subject to review. Rather, a finding of noncompliance that results in the imposition of an enforcement remedy, except the remedy of monitoring by the state, triggers a right to request a hearing and is subject to review. 42 C.F.R. §§ 488.408(g), 498.3(b)(8), (13). Furthermore, the level of noncompliance, i.e., scope and severity, is subject to review only if a successful challenge would: (1) affect the amount of CMP that may be imposed, i.e., the higher range of CMP authorized for immediate jeopardy; or (2) affect a finding of substandard quality of care that rendered the facility ineligible to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14), (16). 

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The determination of immediate jeopardy must be upheld unless Petitioner shows the declaration of immediate jeopardy was clearly erroneous. 42 C.F.R. § 498.60(c)(2). CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination. Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005), aff’d, Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs., 174 F. App’x 932 (6th Cir. 2006)); Maysville Nursing & Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab Ctr. – Johnston, DAB No. 2031 at 18-19 (2006), aff’d, Liberty Commons Nursing & Rehab. Ctr. – Johnson v. Leavitt, 241 F. App’x 76 (4th Cir. 2007). 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 the determination is clearly erroneous. Cal Turner, DAB No. 2384 at 14-15; Liberty Commons Nursing & Rehab. Ctr. – Johnston, 241 F. App’x 76 at 3-4. 

Many appellate panels of the Board have addressed “immediate jeopardy.”¹⁷ In Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented: 

CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous. 42 C.F.R. § 498.60(c)(2); Woodstock Care Center. The “clearly erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one. See, e.g., Maysville Nursing & Rehabilitation Facility, DAB No. 2317, at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031, at 18 (2006), aff’d, Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007). When CMS issued the nursing facility survey, certification, and enforcement

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regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries.” 59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994). “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.” Daughters of Miriam Center, DAB No. 2067, at 15 (2007). 

The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations. In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however. As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries. Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior. Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility. While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers. Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise

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concepts. For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.

59 Fed. Reg. at 56,179 (emphasis added). It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration, by adopting the clearly erroneous standard of review. Thus, caution must be exercised to ensure that the Board’s decisions in Mississippi Care Ctr. of Greenville, Daughters of Miriam Ctr., and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard. Mississippi Care Ctr., DAB No. 2450 at 15; Daughters of Miriam Ctr., DAB No. 2067 at 15. Giving or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation, would significantly limit the review of the determination by an ALJ and the Board, and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation. 

In the foregoing quotation from Mississippi Care Ctr. of Greenville, that panel of the Board states that the clearly erroneous standard means that “CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.” DAB No. 2450 at 15. Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.” However, the Board’s characterization of the “clearly erroneous standard” in Mississippi Care Ctr. and other cases does not define the standard. The “clearly erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed. Black’s Law Dictionary at 269 (8th ed. 2004). The Supreme Court has addressed the “clearly erroneous standard” in the context of the APA. The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence. In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr., 508 U.S. 602, 622 (1993). The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999). Under the “clearly erroneous”

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standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed. United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622. The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential. The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding. The Court also commented that the APA requires meaningful review.¹⁸ Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23. 

Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue. A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm. Dumas Nursing & Rehab., L.P., DAB No. 2347 at 19 (2010) (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff’d, Life Care Ctr. of Tullahoma v. Sec’y of U.S. Dep’t of Health & Human Servs., 453 F. App’x 610 (6th Cir. 2011)). The definition of immediate jeopardy at 42 C.F.R. § 488.301 does not define “likelihood” or establish any temporal parameters for potential harm. Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011). The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard. Brian Ctr. Health, DAB No. 2336 at 7-8. There is a difference between “likelihood” as required by the definition of immediate jeopardy and a mere potential. The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential. Daughters of Miriam Ctr., DAB No. 2067 at 10. Jeopardy generally means danger, hazard, or peril. The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences. Woodstock Care Ctr., DAB No. 1726.

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301? How does serious injury, harm, or impairment compare with “actual harm”? On the first question, the Board recognized, in Yakima Valley Sch., that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy. DAB No. 2422 at 8. The

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Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy, there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.” Id. (citing Daughters of Miriam Ctr., DAB No. 2067 at 9). In Daughters of Miriam Ctr., the Board discussed that the ALJ attempted in that case to define “serious,” finding meanings such as dangerous, grave, grievous, or life-threatening. The Board noted that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences. The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain. The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case. The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious. Daughters of Miriam Ctr., DAB No. 2067 at 9-10. 

Petitioner argues that CMS has failed to show that the noncompliance under 42 C.F.R. § 483.80 posed immediate jeopardy.¹⁹ P. Br. at 17-20. However, Petitioner has the burden to show that the declaration of immediate jeopardy was clearly erroneous, including the period of immediate jeopardy. Petitioner has failed to meet its burden. The evidence shows that Petitioner determined that it could no longer care for and protect its COVID-19 negative residents and transferred all except Residents 1 and 2 to another facility. In deciding to not transfer Residents 1 and 2 and not segregating them from COVID-19 positive residents as required by Petitioner’s existing IPCP, and then failing to follow its existing IPCP and review and revise its IPCP considering the changed circumstances, Petitioner placed both residents at increased risk to contract COVID-19. Petitioner has presented no evidence and does not dispute that COVID-19 is believed to

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be one of the deadliest diseases for elderly and immunocompromised individuals, in recent history. The consent forms Petitioner had the representatives of Residents 1 and 2 sign, are evidence that Petitioner knew there was a risk for the residents to contract COVID-19 with resulting serious harm or death. The consent forms show that Petitioner sought to avoid responsibility for the risk of harm to Residents 1 and 2 and any harm they suffered. P. Ex. 11. The fact that all other COVID-19 negative residents were transferred is also evidence that Petitioner appreciated the risk for serious harm or death to residents secondary to COVID-19 infection. Petitioner’s argument that Residents 1 and 2 did not contract COVID-19 does not establish that there was no risk for serious harm or death or that Petitioner’s ad hoc interventions were effective to reduce the risk for harm so that there was a risk for no more than minimal harm. 

Applying the clearly erroneous standard to the record before me related to the noncompliance based on the violation of 42 C.F.R. § 483.80, I have no definite and firm conviction that an error has been committed in the determination that immediate jeopardy existed and that it existed from November 16 through 22, 2020. I have been cautious not to grant CMS double deference, i.e., application of the clearly erroneous standard is what it required with no additional deference granted. I have carefully evaluated Petitioner’s evidence and arguments and do not “rubber stamp” the CMS determination that there was immediate jeopardy. Accordingly, I conclude Petitioner has not met its burden to show that the determination of immediate jeopardy or its duration were clearly erroneous.

5. A CMP of $9,500 per day from November 16 through 22, 2020, and $250 per day for the period November 23 through December 29, 2020, is a reasonable enforcement remedy. 

6. A DPNA from December 24 through 29, 2020, is a reasonable enforcement remedy. 

I have concluded that Petitioner violated 42 C.F.R. § 483.80 and the violation posed a risk for more than minimal harm to Petitioner’s residents. I have also concluded that Petitioner has failed to show that the declaration of immediate jeopardy for the period November 16 through 22, 2022, was clearly erroneous. 

If a facility is not in substantial compliance with program participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP. CMS may impose a per day CMP for the number of days that the facility is not in compliance or a per instance CMP for each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a). The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP – $6,808 per day to $22,320 per day – is reserved for deficiencies that pose immediate

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jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020). The lower range of CMPs – $112 per day to $6,695 per day – is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2020). There is a single range of CMPs for a per instance CMP. 

I am to determine whether the amount of any CMP proposed is within reasonable bounds, considering the purpose of the Act and regulations. Emerald Oaks, DAB No. 1800 at 10; CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997). My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me. I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation. If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e). The limitations are that I may: (1) not set the CMP at zero or reduce it to zero; (2) not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount. 

In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered: (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor. The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b): (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread. 

Based on my consideration of the regulatory factors, I conclude that the CMP imposed in this case is reasonable. I have received no evidence that Petitioner had a history of noncompliance prior to the survey at issue. Petitioner does not argue that its financial condition affects its ability to pay the proposed CMP. Petitioner’s noncompliance was serious because it posed immediate jeopardy for Residents 1 and 2. Petitioner was

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culpable. Petitioner’s management made the decision to treat Residents 1 and 2 as if they were infected with COVID-19 and effectively stopped trying to prevent them from becoming infected. Petitioner stopped following its existing IPCP to segregate COVID-19 positive residents with dedicated staffing. Petitioner also failed to review and revise its IPCP when all COVID-19 negative residents but Residents 1 and 2 were transferred and Residents 1 and 2 were permitted to reside with and share staff with COVID-19 positive residents.

Petitioner argues no enforcement remedy is reasonable because there was no noncompliance. Petitioner argues that if there was noncompliance it did not pose immediate jeopardy and no CMP in the upper range should be imposed. Petitioner argues that CMS elected not to proceed on some of the examples cited by the surveyor. Petitioner argues that immediate jeopardy should not be upheld for November 16, 2020, because that is the day another survey team found no noncompliance. Finally, Petitioner argues that the period of immediate jeopardy could have been shorter if CMS and the state agency had acted more quickly on Petitioner’s plan to abate the immediate jeopardy. P. Br. at 21-22. I conclude that none of Petitioner’s arguments are persuasive. I have concluded that there was noncompliance and that it posed immediate jeopardy justifying a CMP in the upper range. I have also concluded Petitioner failed to meet its heavy burden to show that there was no immediate jeopardy for the period November 16 through 22, 2020. Regarding the matter of abatement of immediate jeopardy, Petitioner presented no evidence that Petitioner reviewed and revised its COVID-19 IPCP to ensure the safety of Residents 1 and 2 before the date immediate jeopardy was abated according to the surveyor. 

I conclude that the CMP of $9,500 per day proposed by CMS for immediate jeopardy during the period November 16 through 22, 2020 is reasonable. The CMP of $9,500 per day is in the lower half of the upper range of authorized CMPs – $6,808 per day to $22,320 per day. The $250 per day CMP is near the bottom of the lower range of CMPs authorized for noncompliance that does not pose immediate jeopardy – $112 per day to $6,695 per day. 42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020). The $250 per day CMP from November 23 through December 29, 2020, is reasonable. I also conclude that the DPNA from December 24 through 29, 2020 is a reasonable enforcement remedy. 

IV. Conclusion

For the foregoing reasons, I conclude that: 

Petitioner was not in substantial compliance with the Medicare participation requirements due to violation of 42 C.F.R. § 483.80 from November 16 through December 29, 2020, that posed a risk for more than minimal harm;

The determination that there was immediate jeopardy from November 16 through 22, 2020, was not clearly erroneous; and

Reasonable enforcement remedies are a CMP of $9,500 per day for the period November 16 through 22, 2020, a CMP of $250 per day for the period November 23 through December 29, 2020, and a DPNA from December 24 through 29, 2020.

Endnotes

¹ References are to the 2020 revision of the Code of Federal Regulations (C.F.R.), unless otherwise indicated. The Board has concluded it is appropriate in long-term care facility survey cases to apply the revision of the regulatory participation requirements in the revision of the C.F.R. in effect at the time a survey was conducted. Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 1 n.1 (2018); Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996). Petitioner was bound to comply with the 2020 revision of the regulations when the noncompliance is alleged to have occurred in this case. 

² One could speculate that the document CMS was instructed to file is the same as or like the document admitted as P. Ex. 1. However, there is little evidence in support of such speculation. P. Ex. 1 appears to set forth Texas policy as of June 2, 2020, and in the absence of the document relied upon by the surveyor, it is accepted as setting forth standards in Texas to be applied by nursing homes in Texas dealing with COVID-19. 

³ Some parts of P. Ex. 3 offered as evidence were unreadable. Therefore, after discussion at hearing, Petitioner filed a more readable copy of P. Ex. 3 (DAB E-File # 28), which is considered as evidence rather than the unreadable version. Tr. 65-70, 76-78, 117-19. 

⁴ SNFs and NFs are often referred to as long-term care facilities or nursing homes. NF participation in Medicaid is governed by section 1919 of the Act. Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act. 

⁵ CMS annually adjusts CMP amounts that may be imposed to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015). 81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016).

⁶ Congress granted the Secretary authority to impose enforcement remedies for noncompliance. Act § 1819(h)(2). The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act. CMPs are imposed by CMS with delegated authority of the Secretary. 42 C.F.R. § 488.2. Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act. The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act. Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP. Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party. The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence. 20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d). CMS failed to promulgate a regulation like those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP. 

⁷ Certainly, Petitioner has the option not to offer any evidence at hearing, attempting to avoid having its evidence considered in determining whether CMS made a prima facie showing of noncompliance. However, in cases subject to 42 C.F.R. pt. 498, the parties are generally required by the ALJ to exchange evidence well in advance of hearing. Whether Petitioner’s evidence filed as part of an exchange might be treated by the Board as evidence going to support the CMS prima facie case is an open question. 

⁸ CMS withdrew its offer of CMS Ex. 7 as evidence. Therefore, CMS did not offer as evidence any records of Petitioner obtained by the surveyor during the survey. Because CMS presented no surveyor testimony, the SOD (CMS Ex. 2) was admitted for the limited purpose of showing that CMS gave Petitioner notice of the allegations of noncompliance. The surveyor’s notes (CMS Ex. 6) were also not admitted. Therefore, the CMS prima facie case is based upon the undisputed allegations of fact and the evidence offered by Petitioner. 

⁹ The refinement of the CMS position reveals a great benefit of conducting an adversarial proceeding during which the parties can interrogate the witnesses and develop a more accurate view of the evidence and what theories are supported. 

¹⁰ “Credible evidence” is evidence that is worthy of belief. Black’s Law Dictionary at 596 (18th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence compared to other evidence. Id. at 1625. 

¹¹ CMS Ex. 6 was not admitted as evidence because the surveyor was not present at the hearing and not subject to cross-examination. CMS Ex. 6 is not considered as substantive evidence but, only as evidence of what the surveyor considered when making the allegations of noncompliance in the SOD (CMS Ex. 2). 

¹² Petitioner is required to have one or more infection preventionists who are responsible for its IPCP. 42 C.F.R. § 483.80(b). Petitioner is required to have a quality assurance performance improvement (QAPI) program that focuses on quality improvement in all areas of care and services for its residents. 42 C.F.R. § 483.75. As part of its QAPI, Petitioner must have a quality assessment and assurance committee that includes the DON, the medical director, three others in specified positions, and the infection preventionist. 42 C.F.R. § 483.75(g). Petitioner is required to designate a physician to serve as its medical director by 42 C.F.R. § 483.70(h).

¹³ The consent forms are in evidence marked as P. Ex. 11 pages 1 and 3. The forms indicate that the residents’ representatives declined to have the residents transferred to a facility without COVID-19 infection and agreed that the residents could be treated by staff who also treated COVID-19 positive residents. The forms state that the signatories recognized the residents were at risk for contracting COVID-19. 

¹⁴ According to the facility floor plan, Petitioner had Halls A, B, C, D, F, and H. P. Ex. 12. 

¹⁵ Pursuant to 42 C.F.R. § 483.15(c)(1),

(i) The facility must permit each resident to remain in the facility, and not transfer or discharge the resident from the facility unless –

(A) The transfer or discharge is necessary for the resident’s welfare and the resident’s needs cannot be met in the facility. . . .

Transfer or discharge may occur before action on any appeal by the resident of the facility decision to transfer or discharge if resident health or safety would be jeopardized by failure to transfer or discharge. A facility must document the danger posed by failure to transfer or discharge. 42 C.F.R. § 483.15(c)(1)(ii). Petitioner was not charged for violation of 42 C.F.R. § 483.15(c)(1). However, the regulation clearly imposes the burden of the transfer or discharge decision upon the facility and that burden is triggered when a resident’s welfare cannot be protected, and the resident’s needs cannot be met in the facility. A resident’s preference or the preference of a resident’s representative or family are not considerations under the federal regulation. It is the facility that is best positioned to determine if it can meet a resident’s needs and not a resident or resident’s representative. The regulation does not provide that Petitioner can satisfy or avoid the obligation created by the regulation by obtaining a signed waiver of a resident or resident’s representative. 

¹⁶ Congress has limited the authority of the Secretary and components of HHS, such as CMS and CDC, to control the practice of medicine by dictating standards of care. Section 1801 of the Act provides: 

Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person. 

¹⁷ Decisions often cited include: Lakeport Skilled Nursing Ctr., DAB No. 2435 at 7 (2012); Liberty Health & Rehab of Indianola, LLC, DAB No. 2434 at 13, 18-19 (2011); Yakima Valley Sch., DAB No. 2422 at 8; Lutheran Home at Trinity Oaks, DAB No. 2111 (2007); Britthaven of Havelock, DAB No. 2078 (2007); Daughters of Miriam Ctr., DAB No. 2067 (2007); Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No. 1726 at 39. 

¹⁸ The Board’s characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttable presumption, is entirely consistent with the Supreme Court’s characterization of the standard. However, the Court’s cautions about ensuring meaningful review rather than rubber-stamping agency decisions show it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue. 

¹⁹ Petitioner argues that the surveyor failed to satisfy the requirements for declaring immediate jeopardy of CMS Pub. 100-07, State Operations Manual (SOM), app. Q – Core Guidelines for Determining Immediate Jeopardy, which is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_q_immedjeopardy.pdf. The SOM does not have the force and effect of law. Ind. Dep’t. of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993). The SOM is a policy document that gives guidance to surveyors. My de novo review does not involve determining whether the surveyor met the requirements of SOM app. Q.