Midlothian Healthcare Center, DAB CR6369 (2023)

DECISION

I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS) and sustain the imposition of the following remedies against Petitioner, Midlothian Healthcare Center, a skilled nursing facility:

• Civil money penalties of $12,730 for each day of a period that began on November 11, 2020, and continued through November 16, 2020; and
• Civil money penalties of $330 for each day of a period that began on November 17, 2020, and continued through December 16, 2020.

I. Background

This case was very recently transferred to me from the docket of another administrative law judge.  Reviewing the file, I discovered that there was a pending motion for summary judgment filed by CMS and opposed by Petitioner.

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I am deciding this motion employing the well-established criteria for imposition of summary judgment.  I base my decision only on undisputed material facts.  In evaluating the facts, I make no credibility findings and I draw all possible reasonable inferences that are favorable to Petitioner.

Each party filed exhibits in support of its respective arguments.  CMS filed exhibits that it identified as CMS Ex. 1-CMS Ex. 7 and Petitioner filed exhibits that it identified as P. Ex. 1-P. Ex. 45.  I do not receive these exhibits into evidence as I am granting summary judgment.  However, I cite to some of them to illustrate facts that are undisputed or to identify relevant compliance standards.

The parties’ exhibits include several witness declarations.  For purposes of deciding whether to grant summary judgment I accept as true all the witnesses’ fact assertions that are evidence-based.

II. Issues, Findings of Fact and Conclusions of Law

1. Issues

The issues are whether the undisputed material facts establish that:  Petitioner failed to comply substantially with a Medicare participation requirement; Petitioner’s noncompliance was so egregious as to put residents of Petitioner’s facility at immediate jeopardy; and CMS’s remedy determinations are reasonable in amount and duration. 

2. Findings of Fact and Conclusions of Law

This case turns on Petitioner’s compliance with 42 C.F.R. § 483.80.  The regulation states that a Medicare-participating skilled nursing facility must: 

establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.

A skilled nursing facility must do more than have a plan for dealing with infections, it must implement (“maintain”) that plan.  The efficacy with which a skilled nursing facility implements its infection prevention and control program is a significant consideration when evaluating compliance pursuant to the regulation.

Among other things, the regulation requires that a skilled nursing facility’s infection prevention and control program must, at a minimum, establish a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals who provide

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services under contract, and that system must follow accepted national standards.  42 C.F.R. § 483.80(a)(1).

The regulation identifies specific elements that a facility’s infection prevention and control program must have.  A skilled nursing facility must establish a system of surveillance that is designed to identify possible communicable diseases or infections before they can spread to other persons.  42 C.F.R. § 483.80(a)(2)(i).  The facility must utilize standard and transmission-based precautions to prevent the spread of infection.  42 C.F.R. § 483.80(a)(2)(iii).  The facility’s infection prevention and control plan must explain when and how isolation (quarantine) should be used to protect residents from those who may be infected.  42 C.F.R. § 483.80(a)(2)(iv)(A)(B).  The facility must establish a system for recording incidents identified under its infection prevention and control plan and the corrective actions that the facility takes.  42 C.F.R. § 483.80(a)(4).

CMS asserts that Petitioner failed to comply with the regulation’s requirements.  It alleges Petitioner failed to quarantine a newly-admitted resident, violating national standards for infection control addressing infections by the Covid-19 virus (Covid), published by the Centers for Disease Control (CDC) and by the Texas Health and Human Services Commission (HHSC).  It contends that, during November 2020, when the facility became beset with infections caused by the Covid, the facility’s staff failed to follow quarantine procedures prescribed by CDC and HHSC, thereby creating a likelihood that uninfected residents would become infected.  CMS alleges that Petitioner’s staff attempted to identify infected residents with the use of antigen tests that the Food and Drug Administration had warned were unreliable.

CMS alleges additionally that Petitioner failed to follow its own screening procedures that were intended to protect residents and staff from infected individuals entering the facility’s premises.

The undisputed material facts amply support CMS’s assertions.  They establish unequivocally that Petitioner failed in some respects to implement its own policies for addressing Covid.  They establish as well that Petitioner failed to act in accordance with national standards for dealing with Covid.

1. Failure to quarantine residents

Petitioner adopted a policy to address Covid as an addendum to its overall infection prevention and control plan.  P. Ex. 17.  Petitioner’s Covid policy discusses how to protect residents of its facility from residents with “unknown” infection status.  Id. at 3.  The policy provides generally that residents of unknown status must be quarantined for 14 days.  Residents who must be quarantined include those who refuse to be tested for

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Covid and those who are new admissions to the facility with Covid test results that are more than 48 hours old. ¹  Id.

Using testing to identify infected residents conflicts with guidance from official sources, no matter which tests are utilized.  That guidance unequivocally tells skilled nursing facilities that they must quarantine residents with unknown Covid status for 14 days and that facilities should not rely on testing to create an exception to that rule.

The CDC advised skilled nursing facilities that, generally, all newly-admitted residents should be quarantined for 14 days even if they had a negative Covid test on admission.  Interim Infection Prevention and Control Recommendations to Prevent SARS-Co-V-2 Spread in Nursing Homes.  Similarly, HHSC told skilled nursing facilities that residents with unknown Covid status must quarantined for 14 days.  P. Ex. 23 at 17.  HSSC stated that “Testing is not an option for decreasing the 14-day period” and that “CDC guidance does not provide an exception to quarantine based on testing results.”  P. Ex. 9 at 8-9.

The undisputed facts are that Petitioner – notwithstanding CDC and HSSC policies and guidance – failed to quarantine a newly-admitted resident and also residents with unknown Covid status.  It thus exposed uninfected residents to those who were potentially infected, thereby facilitating spread of the disease.

On October 18, 2020, Petitioner admitted a resident to its facility who is identified as Resident # 1.  P Ex. 4 at 18.  The resident was of unknown Covid infection status, but had two negative Covid tests, the most recent (apparently, the less accurate antigen test) being on the date of his admission.  Id.  Petitioner did not quarantine Resident # 1, but housed him with uninfected residents.  On November 6, 2020, Resident # 1 was admitted to a hospital, suffering from Covid.  Id.

Three days after Resident # 1 tested positive for Covid, Petitioner’s staff administered antigen tests to all residents residing on the corridor where Resident # 1 had resided (“400 Hall”).  P. Ex. 1 at 1; P. Ex. 2 at 5; P. Ex. 4 at 18; P. Ex. 6 at 3.  The staff separated those residents who tested positive from those who tested negative.  P. Ex. 2 at 5; P. Ex. 6

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at 3.  Petitioner did not quarantine the residents who tested negative even though antigen tests are not reliable, and these residents’ Covid infection status remained uncertain. Rather, it moved those residents to various other parts of its facility, thereby potentially exposing uninfected residents to those who were of doubtful status.  P Ex. 4 at 18.

Petitioner’s failure to quarantine Resident # 1 upon his admission, its delay, for three days, to address the hazards caused by Resident # 1’s infection, the reliance of Petitioner’s staff on antigen testing to decide who was infected with Covid, and Petitioner’s failure to quarantine those residents of 400 Hall who had been exposed to Resident # 1, were in plain violation of both CDC and HSSC policies and the regulatory requirement that Petitioner establish and maintain an effective infection prevention and control program. 

I have considered Petitioner’s arguments in opposition to these conclusions.  I find them to be without merit.

First, Petitioner contends that CDC guidelines are merely advisory and are not national standards of infection control to which Petitioner must adhere.  Midlothian Healthcare Center’s Response to Respondent’s Motion for Summary Judgment (Petitioner’s brief) at 3, 6-8.  Characterizing the guidelines as “guidance” and not standards, Petitioner asserts that they lack the force of law because they were not published as regulations in accord with the requirements of the Administrative Procedure Act, 5 U.S.C. §§ 551-559.  Id. at 6-7.  Petitioner contends that to require it to adhere to CDC guidelines would be “ad hoc regulatory obligations from general regulatory language for the purpose of imposing sanctions without first giving the facility notice of the specific standards to which it will be held. . . .”  Id. at 7.

I agree with Petitioner’s assertion that CDC guidelines are not published regulations.  But concluding that CDC guidelines are not regulations does not mean that they are not authoritative or that they are not national standards applicable to skilled nursing facilities.  CDC is a major operating component of the Department of Health and Human Services and serves as the nation’s public health agency.  Its mission is to protect public health and safety by controlling and preventing diseases, particularly infectious diseases.  See http://cdc.gov/about/organization/mission.htm.  Given its expertise and its dominant national role in controlling infectious disease, CDC guidance effectively defines “accepted national standards.”²  Regulatory authority that requires that Petitioner follow CDC guidelines is not stated in the guidelines themselves, but at 42 C.F.R. § 483.80(a)(1).

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Here, the CDC made it clear that there was a significant risk that potentially-exposed residents would, if not quarantined, transmit Covid to uninfected residents.  The CDC also explicitly rejected using tests as a substitute for quarantine.

HHSC, which offers authoritative guidance for facilities in Texas, issued its own guidelines concerning quarantine of potentially-exposed residents.  P. Ex. 23 at 17-18.  HHSC’s guidelines mirror CDC’s guidance.  HHSC guidelines expressly state that all residents whose status is unknown must be quarantined for 14 days.  HSSC guidelines prohibit the use of tests as a substitute for quarantine, concluding that testing is not an option for decreasing the quarantine period and affirming that CDC guidance does not provide an exception to quarantine requirements for residents whose tests are negative.  P. Ex. 9 at 8-9.

Petitioner offers the testimony of its medical director, Deepak Patel, M.D., as justification for its failure to follow CDC and HHSC guidelines.  P. Ex. 1.  Dr. Patel avers, first, that: “it felt like regulations and guidance was changing every five minutes.  They were certainly changing hourly, and daily.  It was impossible for. . . [Petitioner] to keep up.”  Id.

Dr. Patel’s assertion is an opinion, and it is not buttressed by facts.  Petitioner offers no facts to show that CDC guidelines respecting quarantine of exposed residents were changing “hourly, and daily,” or at all in November 2020.

Next, Petitioner contends that it lacked the staff and resources to comply with CDC guidelines.  Dr. Patel asserts that:  “while it would have been ideal for . . . [Petitioner] to have dedicated staff just for its ‘warm unit’ where residents were under quarantine, it was not practical.  It would have been a logistical nightmare.”  P. Ex. 1.  Dr. Patel also avers that, during the pandemic, staffing at Petitioner’s facility was so low that management staff was passing medications to residents and fulfilling the duties of nursing assistants.  Id.

Petitioner does not offer facts that support these conclusions.  Dr. Patel does not provide evidence of staff shortages in November 2020.  I note that Dr. Patel does not describe his duties as including supervision of staff.

Petitioner also offers the affidavit of Greg Loudermilk, LNFA, who was Petitioner’s administrator in November 2020.  P. Ex. 2.  He asserts that Petitioner lacked the staff to maintain a separate hall in its facility for quarantined residents.  Id.

Mr. Loudermilk doesn’t support his conclusion with facts.  Petitioner did not offer evidence, such as a staffing roster, showing that it was short-staffed in November 2020.  Nor did Petitioner offer a cogent explanation of why its staff couldn’t cope with a

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rearrangement of residents’ room assignments that would have isolated potentially-infected residents.

Moreover, the undisputed facts support a different conclusion – that Petitioner had the wherewithal in November 2020 to quarantine its potentially-infected residents. The undisputed facts are that there was a total of 17 residents in the 400 Hall including Resident # 1, when Resident # 1 tested positive for Covid.  Nine of these residents, in addition to Resident # 1, tested positive for Covid and these residents remained in their rooms.  P. Ex. 4 at 18.  That left just seven residents who had been exposed to Covid but who tested negative for infection.  Id.  Mr. Loudermilk offers no explanation for why it would have been impossible to quarantine just seven residents given that they were a very small subset of Petitioner’s overall resident capacity of 98 beds.  Id. at 16. 

Furthermore, it is undisputed that, on November 11, 2020, Petitioner quarantined the seven exposed residents. On that date, Petitioner moved these residents from their rooms in the 400 Hall to a separate part of its facility that it designated as a “warm zone.”  Petitioner assigned staff to attend to these residents.  P. Ex. 4 at 16.  Petitioner offers no explanation for why it could not have accomplished the same thing five days prior, when Resident # 1 first tested positive for Covid.  Mr. Loudermilk doesn’t address the November 11 move in his affidavit. 

Petitioner argues that it should not be held responsible for complying with HHSC guidance because it was unaware of it.  Mr. Loudermilk avers that he relied heavily on HHSC guidance, receiving e-mails regularly from that agency that he used to keep himself informed.  P. Ex. 2 at 2.  According to Mr. Loudermilk, HHSC inexplicably stopped sending e-mails to him in June 2020.  Therefore, he was unaware of any “cohorting [quarantine] changes to definitions or best practices.”  Id. 

The fact that Petitioner may have stopped receiving e-mails from HHSC did not excuse it from its responsibility to be aware of and to follow HHSC policies.  If Mr. Loudermilk wasn’t receiving e-mails from HHSC, he should have at least contacted that agency to ascertain whether that entity was issuing information that he wasn’t receiving.  Moreover, Petitioner offered nothing to show that HHSC’s policy on quarantine was any different in November 2020 than it was in June of that year. 

Petitioner argues also that CDC guidelines carve out an exception to its quarantine requirement and asserts that this exception applies here.  It avers that the guidelines allow facilities to utilize a “risk-based approach” to decide whether newly admitted residents required quarantine.  Petitioner’s brief at 11.  Petitioner claims that it utilized a risk-based approach to decide that Resident 1 did not need to be quarantined, and therefore, it complied with CDC guidelines.  Id.

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Petitioner’s argument is devoid of any supporting facts.  It offers nothing to show that it assessed the level of Covid transmission in the community at the time that it admitted Resident 1.  The record contains nothing that demonstrates that Petitioner’s staff made a reasoned judgment that Resident 1 was highly unlikely to be infected based on the level of Covid in the community.  What the record shows is that Petitioner relied solely on the resident’s negative Covid tests to conclude that he did not need to be quarantined, a decision that is contrary to both CDC and HHSC guidelines.

Finally, Petitioner seems to argue that the measures that it adopted to protect its residents against Covid infection comported with professionally-recognized standards even if they were inconsistent with the national standards issued by CDC and with HHSC guidelines.  As support it offers the testimony and report of an expert, Mark Lacy, M.D.  P. Ex. 4 at 16-24.

Dr. Lacy is not a fact witness and he offers nothing that would raise a dispute as to material facts.  Furthermore, Dr. Lacy’s report does not support Petitioner’s argument.  Rather, it undercuts it in key respects.

For example, Dr. Lacy avers that Petitioner’s staff did not begin to test potentially exposed residents for Covid infection until November 9, 2020 – three days after Resident # 1 had tested positive and was removed to a hospital.  P. Ex. 4 at 18.  That is an inexplicable lapse of three days during which potentially-infected residents could have infected other residents.

Dr. Lacy acknowledges that Petitioner ultimately segregated its potentially-exposed residents – seven individuals – from other residents.  P. Ex. 4 at 18.  As I discuss above, that suggests that Petitioner was late in implementing this protective measure.  It does not support Petitioner’s assertion that it lacked the staff to implement it.

Dr. Lacy also acknowledges that antigen testing produces less reliable results than PCR testing produces.  P. Ex. 4 at 16.  That undercuts Petitioner’s argument that it could rely on antigen testing in lieu of quarantine. 

2. Failure to screen for potential infection in compliance with Covid infection prevention and control policy

Petitioner’s Covid prevention and control policy provides that it would “[a]ctively screen all individuals entering the facility. . . .”  P. Ex. 17 at 2.  The screening process includes asking these individuals about their symptoms.  It provides that individuals’ temperature will be taken “upon entry.”  Id.  The policy provides further that certain individuals will be barred from entry to Petitioner’s facility, including anyone with symptoms of respiratory illness and anyone who has worked in another healthcare setting with confirmed cases of Covid.  Id.

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HHSC instructs – consistent with CDC recommendations – that staff be screened for Covid symptoms prior to entering their facility.  P. Ex. 23.

However, the undisputed facts prove that in practice Petitioner was noncompliant with HHSC guidelines and its own policy.  Petitioner’s screening process was decidedly porous.  That process was riddled with flaws that facilitated infected individuals’ entry into the facility and their access to residents.  Entrants to Petitioner’s facility were able to walk through its corridors without first being screened by any member of Petitioner’s staff.  Visitors could misrepresent their symptoms and temperatures without fear that anyone would question their assertions.  Visitors might exhibit temperatures and symptoms that indicated possible infection—and even record those temperatures and symptoms—but Petitioner’s staff and management would remain unaware because no one was monitoring that information contemporaneously.  

Petitioner did not screen visitors upon entry to the facility.  It did not place staff at entry doors to take visitors’ temperatures and to assess for Covid symptoms.  Visitors walked through the facility’s corridors containing residents’ rooms to a nurses’ station to be screened.  Petitioner’s Pre-hearing brief at 4.  Although Petitioner instructed its staff not to enter residents’ rooms prior to being screened, it offered no facts to show that it assured that staff or other visitors did not do so. 

Petitioner employed an honor system for screening.  Visitors took their own temperatures and answered written questions about their symptoms.  P. Ex. 2 at 6.  Neither Petitioner’s staff nor management reviewed visitors’ temperatures and their symptoms contemporaneously.  Rather, management periodically audited screening records and checked them for accuracy every Thursday.  Petitioner’s Pre-hearing Brief at 4, 11. 

Petitioner offers no persuasive defense to rebut the undisputed facts. 

Petitioner’s principal argument is that it had a screening process in place that did not, on its face, violate HHSC guidelines.  Petitioner’s brief at 8-9.  That may be so, but in this case it isn’t the policy that is at issue, but its implementation.  Petitioner asserts, for example, that screening at its facility was “regularly completed.”  Id. at 8.  However, as the undisputed facts establish, regular completion of Petitioner’s screening process meant that visitors were trusted to enter information without being checked by Petitioner’s staff, and that information was not contemporaneously reviewed by Petitioner’s staff or management. 

Petitioner argues additionally that “nothing in . . . [its] screening policy required in-person screening.”  Petitioner’s brief at 8.  True, but that was the policy’s Achilles’ Heel.  There were literally no safeguards in that policy to protect against incorrect representations by visitors to the facility.  Indeed, there was nothing in Petitioner’s policy

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that would have prevented a visitor from skipping screening altogether, as screening took place at Petitioner’s nurses’ station, a corridor length away from entry to the facility. 

Petitioner argues also that CMS neither alleged nor provided facts to show that any staff member ever violated Petitioner’s screening policy.  Petitioner’s brief at 9.  But CMS isn’t required to prove a negative.  It is enough that the undisputed facts establish that Petitioner’s screening policy was rife with flaws that would enable an infected individual to be on Petitioner’s premises without detection. 

Petitioner claims that its screening policy is supported by expert testimony, citing Dr. Lacy’s report.  Petitioner’s brief at 9; See P. Ex. 4 at 16-24.  But Dr. Lacy does not assert that the screening protocols used by Petitioner protected residents.  P. Ex. 4 at 20.  He asserts only that Petitioner: “had a program in place for staff screening based on symptoms and temperature checks.  This is the same policy applied at most facilities around the country. . . .”  Id.  That is an endorsement of Petitioner’s policy and not its day-to-day implementation.  As I have explained, Petitioner’s deficiency lies in its implementation of its policy. 

Petitioner also asserts that there is no evidence to show that an infected individual might transmit Covid to residents just from walking through Petitioner’s corridors.  Petitioner’s brief at 9.  It goes on to assert that “Indeed, the Facility’s expert has confirmed that, merely walking past a resident room is insufficient to either contract or transmit a COVID-19 infection.” Id. (citing generally to Dr. Lacy’s affidavit). 

I accept as true, for purposes of deciding whether to enter summary judgment, Petitioner’s assertion that an infected individual would not transmit Covid just by walking down a corridor.  But the danger of transmitting an infection lies not in walking through a corridor.  Petitioner imposed no practical restrictions on individuals from outside the facility interacting with those who were inside, once those individuals were inside the facility.  For example, nothing in Petitioner’s screening process prevented an infected individual from stopping and conversing with a staff member as that individual walked to Petitioner’s nurses’ station from an entrance.  Nor did it prevent an infected individual from having a conversation— indeed, even a protracted one—with a staff member at the nurses’ station. 

3. Immediate jeopardy

The term “immediate jeopardy” is defined by regulation to mean noncompliance that is so egregious as to cause, or to be likely to cause, serious injury, impairment, harm, or death to a resident of a skilled nursing facility.  42 C.F.R. § 488.301.  Where CMS determines that noncompliance is at the immediate jeopardy level the burden falls on the facility to prove that determination to be clearly erroneous.  42 C.F.R. § 498.60(c)(2).  A finding of immediate jeopardy level noncompliance is presumptively correct.  Liberty Commons Nursing & Rehab Ctr. - Johnston, DAB No. 2031 at 18-19 (2006), aff’d, Liberty

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Commons Nursing & Rehab Ctr, - Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007). 

In cases where I hold evidentiary hearings, I would evaluate a finding of immediate jeopardy by asking whether evidence proved that the finding is clearly erroneous.  My task is a bit different when considering a motion for summary judgment.  Here, I ask:  has Petitioner offered facts that, assuming their truth, would show that CMS’s immediate jeopardy determination is clearly erroneous? 

I do not find anything in the record that could lead me to conclude that CMS’s determination of immediate jeopardy level noncompliance is clearly erroneous.  

When Covid invades the premises of a skilled nursing facility, the consequences are invariably serious and frequently lethal.  Covid is particularly deadly among the elderly and infirm and has ravaged skilled nursing facility residents.  That is as true in Texas as it is elsewhere—by November 2020 Texas had witnessed thousands of deaths among its nursing home residents.  See e.g., COVID-19 ravaged Texas nursing homes. Here are the stories behind the numbers, Carla Astudillo and Karen Brooks Harper, https://apps.texastribune.org/features/2021/texas-nursing-home-deaths-coronavirus-pandemic/ (last visited September 25, 2023).  There is invariably a likelihood of serious harm or deaths to residents when a skilled nursing facility fails to implement its Covid prevention and control policy or when its staff does not comply with national standards to protect its residents. 

Petitioner offered no facts from which I might infer that CMS’s determination is clearly erroneous.  Petitioner asserts that there is no basis to sustain CMS’s determination because there is no basis to enter summary judgment against it on the issue of compliance with Medicare participation requirements.  Petitioner’s brief at 15-16.  However, and as I discuss above, the undisputed facts unequivocally establish Petitioner’s noncompliance.

4. Remedies

CMS imposed two remedies against Petitioner consisting of:  civil money penalties of $12,730 for each day of a period that began on November 11, 2020, and that continued through November 16, 2020; and civil money penalties of $330 for each day of a period that began on November 17, 2020, and that continued through December 16, 2020.  CMS premised the larger penalties on its determination that Petitioner manifested immediate jeopardy level noncompliance beginning on November 11 and continuing through November 16.  It predicated the smaller penalties on its conclusion that Petitioner continued to be noncompliant, albeit at a less than immediate jeopardy level of scope and severity, through December 16, 2020.

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I sustain both the amount and duration of these remedies.

Regulations establish the criteria for deciding the amount and duration of civil money penalties.  Per-diem civil money penalties, such as those that are at issue here, fall within two ranges, consisting of penalties for immediate jeopardy level noncompliance and penalties for noncompliance that is substantial, but not at the immediate jeopardy level.  42 C.F.R. § 488.438(a)(1)(i),(ii).  Permissible penalty amounts are established by this regulation, as updated annually for inflation.  45 C.F.R. Part 102.  The penalties that CMS determined to impose are well within their respective ranges.  CMS set the immediate jeopardy level penalties at slightly more than half the maximum permissible amount.  The non-immediate jeopardy level penalties are at the bottom of the range of permissible amounts.

Deciding penalty amount within each range depends on evidence relating to factors that are described at 42 C.F.R. §§ 488.438(f)(1)-(4) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  The seriousness of a facility’s noncompliance is one of those factors.

Here, the undisputed facts establish Petitioner’s noncompliance to have been extremely serious.  The seriousness of the noncompliance amply justifies the penalty amounts that CMS determined to impose. 

I have discussed the dangers posed by Covid when it invades a skilled nursing facility’s premises.  Covid in a skilled nursing facility likely will be a death sentence for one or more of its residents.  Failure by a facility to protect its residents against Covid, whether it be a failure to comply with national standards or a failure to comply with the facility’s own policy, merits a substantial remedy.  The remedies imposed here are reasonable when weighed against Petitioner’s noncompliance. 

Petitioner has not challenged the duration of the remedies that CMS imposed except to challenge the noncompliance findings that are the basis for the remedy determinations.  Consequently, I grant summary judgment in favor of CMS and sustain CMS’s determinations of duration of remedies.

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Endnotes

¹  Petitioner’s policy is ambiguous in that it does not define what it means by “tests.”  As of the autumn of 2020 there existed two types of tests for Covid infection.  One type, the antigen test, produced rapid results.  However, the Food and Drug Administration warned that antigen tests could produce false negative results.  CMS Ex. 5 at 6.  The second test, the molecular PCR test, took longer to evaluate but was more sensitive than the antigen test and, therefore, more accurate.  Id.  In not defining what test to use for Covid, Petitioner’s policy left open the possibility that staff might rely on a test that is not necessarily accurate.

²  Petitioner suggests that the question of whether CDC guidelines are national standards is a question of fact that cannot be decided without an in-person hearing.  That is incorrect.  The role and weight of these guidelines is a matter of law.