The Hurlbut, LLC, DAB CR6173 (2022)

DECISION

The case before me involves a long-term care facility’s responsibility to 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.  

Petitioner, The Hurlbut, Inc., (the facility), is a residential health care facility that is licensed to provide skilled nursing care and services in the State of New York.  The New York State Department of Health (NYSDOH) is designated as the state survey agency for New York State for monitoring compliance with the Centers for Medicare & Medicaid Services’ (CMS’s) federal nursing home rules and regulations.  During a COVID-19 Focused Infection Control Survey that was completed on April 23, 2020 and conducted at the facility, NYSDOH determined that the facility was not in substantial compliance with Medicare participation requirement Tag F880, 42 C.F.R. § 483.80, because the facility failed to protect three asymptomatic non-COVID-19 residents who were residing in the same room with residents who had COVID-19.

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For the reasons discussed below, I find that the facility was not in substantial compliance with the Medicare program requirements (42 C.F.R. § 483.80) and that the penalty imposed is reasonable. 

I.    Procedural Background

Based on the April 23, 2020 survey, NYSDOH found Immediate Jeopardy (determined to be the most serious deficiency), effective April 23, 2020, under the requirements of 42 C.F.R. § 483.80, Infection Control, Tag F880.  CMS Exhibit (Ex.) 1. 

On the evening of April 23, 2020, Petitioner submitted an allegation letter for removal of the Immediate Jeopardy citation.  On April 24, 2020, an onsite survey was conducted, and, as a result, the Immediate Jeopardy for Tag F880 was abated.  However, the facility remained out of compliance.  CMS Ex. 1 at 1, 7-8.  

On May 15, 2020, Petitioner submitted a request for a panel informal dispute resolution (IDR).  Petitioner’s Request for Hearing (RFH).  In a September 17, 2020 letter, CMS imposed a Civil Money Penalty (CMP) of $9,085.00 per day for two days, April 22 and April 23, 2020, a total of $18,170.00.  CMS Ex. 2 at 2.  On November 20, 2020, Petitioner submitted a request for a hearing (RFH) before an Administrative Law Judge (ALJ).  On November 24, 2020, the presiding ALJ¹ issued an Acknowledgment of Receipt of Request for Hearing, as well as an Order that set deadlines for the parties to file pre-hearing briefs in this matter.  The Order further set deadlines for the parties to submit their written request and intention to cross-examine opposing party witnesses.  On February 19, 2021, CMS submitted a Pre-Hearing Brief and Motion for Summary Judgment (CMS Br.).  CMS submitted 22 exhibits, including the written declarations for three witnesses.  On March 26, 2021, Petitioner submitted a Pre-Hearing Brief and Opposition to Respondent’s Motion for Summary Judgment². Petitioner’s Brief (P. Br.).  Petitioner submitted eight exhibits, including the written declarations for three witnesses.  Neither party submitted objections to opposing party exhibits.  Accordingly, I receive CMS Exs. 1-22 and P. Exs. 1-8.

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As neither party submitted a written request to cross-examine the opposing party’s witnesses, a hearing is unnecessary for the purpose of cross-examination of witnesses.  Although CMS moved for summary judgment, I find that this matter may be decided on the written record, without considering whether the standards for summary judgment are met.  

II.    Applicable Legal Authorities

The Social Security Act (Act) sets forth requirements for skilled nursing facilities (SNFs) or long-term care (LTC) facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in Medicare, a LTC facility must be in “substantial compliance” with the participation requirements in 42 C.F.R. Part 483, subpart B.  42 C.F.R. §§ 483.1, 488.400.  A “deficiency” is a “failure to meet a participation requirement.”  Id.; 42 C.F.R. § 488.301.  An LTC facility is not in “substantial compliance” when it has one or more deficiencies that have the potential for causing more than minimal harm to residents.  Id. 

The Secretary contracts with state survey agencies to survey LTC facilities to determine whether they are in substantial compliance with program requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  CMS may impose enforcement remedies based on the survey results, including a per-day CMP, on an LTC facility that is not in substantial compliance.  42 C.F.R. §§ 488.400, 488.402(b), (c), 488.406.  CMS determines the amount of a CMP based on multiple factors, which includes the “seriousness” of the noncompliance. 42 C.F.R. §§ 488.404(b), 488.438(f).  “Seriousness” is a function of the noncompliance’s scope (whether it is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether it has created a “potential for harm”, resulted in “actual harm,” or placed residents in “immediate jeopardy”).  42 C.F.R. § 488.404(b).  The most serious noncompliance is that which puts one or more residents in “immediate jeopardy.”  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; see 42 C.F.R. § 488.438(a) (authorizing the highest CMPs for immediate-jeopardy-level noncompliance); Woodland Oaks Healthcare Facility, DAB No. 2355 at 2 (2010). 

III.    Issues

The issues before me are: 

1. Whether the facility was in substantial compliance with 42 C.F.R. § 483.80;
2. If the facility was not in substantial compliance, whether its deficiencies posed immediate jeopardy to resident health and safety, and;

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3. Whether the CMP imposed for the period of immediate jeopardy is reasonable.

IV.    Findings of Fact, Conclusions of Law, and Analysis³

A. Petitioner was not in substantial compliance with 42 C.F.R. § 483.80. 

1. Governing Guidelines and Authority

42 C.F.R. § 483.80 provides that a LTC 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. The Facility’s Policies for Dealing with COVID-19

On February 29, 2020, the facility issued guidelines with the stated purpose, “To provide guidance on infection control and isolation precautions for residents suspected or diagnosed with 2019 Novel Coronavirus (COVID-19).  Guidance is subject to change and is based upon the most current Centers for Disease Control (CDC) guidelines and updates.”  For residents who are positive or suspected to have COVID-19, the guidelines provide: 

If the resident resides in a semi-private room, the resident’s roommate will be considered potentially infected.  If possible, the roommate should be moved to an empty room and be maintained on Standard, Contact and Droplet precautions until COVID-19 is ruled out.  If the residents have to remain in the same semi-private room, all staff interactions with the resident’s roommate will require gown, facemask, goggles, and gloves.  If an N95 respirator is available for use, this will be used in place of the facemask.  The privacy curtain will be utilized at all times.  

CMS Ex. 11 at 3.  

The guidelines also provide that immediately after identification of a suspected case, a surgical mask will be placed on the resident, if tolerated, and the door to the room closed.  CMS Ex. 11 at 2.  In caring for residents who are suspected or confirmed to have COVID-19, the guidelines provide for hanging plastic overlapping shower curtains in the doorway and taping the sides.  CMS Ex. 11 at 6.

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Petitioner’s undated Emerging Infectious Disease Response provides for the separation of an individual or group reasonably suspected to be infected with a communicable disease from those who are not infected to prevent the spread of the disease.  CMS Ex. 4 at 1.  

b. Regulatory Guidelines for Dealing with COVID-19

On April 2, 2020, CMS and the Center for Disease Control and Prevention (CDC) issued “COVID-19 Long-Term Care Facility Guidance” with recommendations for actions to keep LTC facility residents safe.  The guidelines provide that “Long-term care facilities should separate patients and residents who have COVID-19 from patients and residents who do not or have an unknown status.”  CMS Ex. 3 at 3.  The guidelines also provide that, when possible, facilities should exercise consistent assignment, or have separate staff teams for COVID-19 positive and COVID-19 negative patients.  Id.

2. Background

CMS upheld NYSDOH’s determination that for 6 out of 82 residents reviewed, the facility failed to establish and maintain an infection prevention and control program designed to help prevent the development and transmission of COVID-19 and that such non-compliance constituted immediate jeopardy to resident health and safety.  CMS Br. at 2; CMS Ex. 1 at 1-8.

In finding that the facility was not in compliance with 42 C.F.R. § 483.80, NYSDOH found that the facility failed to protect three asymptomatic non-COVID residents who were residing in the same room with residents that had COVID-19.  CMS Br. at 9.

a. Residents 1 and 2

At the time of the April 2020 survey, Residents 1 and 2 were roommates.  Resident 1 (R1) tested negative for COVID-19 in a lab test, dated March 31, 2020.  CMS Ex. 5 at 14.  Records show that during the period from March 13, 2020 through April 16. 2020, R1 showed no signs of respiratory issues or fever.  CMS Ex. 14 at 10; CMS Ex. 5.  On April 22, 2020, Resident 2 (R2) began presenting with cough, fatigue, and unsteady gait.  Based on the symptoms, the resident was presumed to have COVID-19 and the resident was tested at 2:00 p.m. on that same day.  Test results confirming that R2 tested positive for COVID-19 were received at 10:56 p.m. on April 22.  CMS Ex. 6 at 5.  The state surveyor documented that on April 23 at 11:30 a.m. and again at 6:00 p.m., both residents were observed in the same room with the privacy curtain open.  Neither resident was wearing a mask.  CMS Ex. 1 at 5.

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b. Residents 3 and 4

As of April 2020, Resident 3 (R3) and Resident 4 (R4) shared a room.  R3’s medical and nursing progress notes from March 17, 2020 through March 31, 2020 showed no evidence or signs or symptoms of respiratory issues or fever.  CMS Ex. 7.  R3 was chosen as a part of a sample group for COVID-19 swabbing operations, and a swab was obtained from the resident and tested on March 31, 2020.  The test showed that R3 was negative for COVID-19.  CMS Ex. 7 at 11.  R4, however, was presumed to be COVID-19 infected as documented in an April 7, 2020 progress note.  The progress note indicated that the facility would not obtain a COVID nasopharyngeal swab to rule out a COVID-19 infection as the resident was in an exposed area and considered positive.  The surveyor noted that at 11:30 a.m. and again at 6:00 p.m. on April 23, 2020, Residents 3 and 4 were observed in the same room.  Neither resident was wearing a mask and the privacy curtain was pulled only approximately one-half closed between the residents.  CMS Ex. 1 at 6.  

c. Residents 5 and 6

A lab test, dated April 14, 2020, revealed that R5 tested positive for COVID-19.  CMS Ex. 9 at 8.  R6 shared the room with R5 and had diagnoses including hypertension and heart failure.  CMS Ex. 10 at 2.  R6 was asymptomatic of respiratory issues at the time that R5 confirmed positive, however, R6 continued to reside in the same room with R5.  There is no dispute that the facility took no action to move either resident out of the room despite R5’s confirmed COVID-19 status.  Finally, after being in the room with R5 for eight additional days, R6 tested positive for COVID-19 on April 23, 2020.  CMS Ex. 1 at 6.  On April 23, 2020, the surveyors observed R5 and R6 in the same room without masks.  Id. 

3. Discussion

Petitioner does not dispute that CMS and CDC guidelines recommended that long-term care facilities designate separate units within a facility to separate COVID-19 negative residents from COVID-19 positive residents and residents with unknown COVID-19 status.  P. Ex. 4 at 3.  Petitioner also acknowledges that CMS guidance required that COVID-19-negative residents remain separate from COVID-19-positive residents and residents with unknown COVID-19 status.  RFH at ¶ 39.  The facility’s February 2020 guideline for addressing COVID-19 in the facility provides for moving the roommate of an infected resident to an empty room and monitoring the resident until COVID-19 is ruled out.  CMS Ex. 11 at 3.  

Initially, the facility moved residents out of their rooms when a roommate tested positive for COVID-19 and signage was posted on the residents’ door to designate their COVID-19 status.  P. Ex. 4 at 9.  Additionally, on or about April 12, 2020, a significant number of

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residents were transferred from the facility to another skilled nursing facility, leaving the facility with an empty unit.  P. Ex. 4 at 4, 10. 

Prior to the survey, however, the facility removed the COVID-19 signage that identified which residents were COVID-19 positive and made the decision to presume that all residents were potentially positive.  P. Ex. 4 at 10.  Two of the facility’s nursing assistants confirmed that they did not know which residents were positive and which were negative.  They used the same personal protective equipment (PPE) when going into the rooms for positive and negative residents and did not change until they came out of the rooms.⁴  CMS Ex. 1 at 6. 

a. Petitioner’s Arguments Concerning Resident Exposure

Petitioner agrees that the facility was mandated to follow guidance from the CDC and CMS.  P. Br. at 7.  Petitioner further acknowledges that CDC guidance stated that nursing homes should avoid placing unexposed residents into a shared space with residents who may have been exposed to individuals with COVID-19.  Id.  Petitioner does not, however, deny that on April 23, 2020, Residents 1 through 6 were housed in shared spaces as CMS alleges. 

Petitioner submits two central arguments for its failure to separate the residents based on their presumed or confirmed COVID-19 status.  Petitioner asserts that because of the spread of COVID-19, the facility was forced to treat all residents as potentially COVID‑19 positive.  P. Br. at 8.  Director of Nursing (DON) Nicole Halsey testified:  “I believe that it is unfair to simply dismiss the fact that there was a distinct possibility for exposure of one roommate following the confirmation of COVID-19 in the other roommate, particularly when the two shared a semi-private room in the period before a positive diagnosis was made.”  P. Ex. 4 at 10.  Accordingly, with the presumption that all residents were potentially positive, the signage which would designate which residents were COVID-19 positive was removed from residents’ doors.  P. Ex. 4 at 10. 

As further justification for its decision to keep confirmed or presumed COVID-19 positive residents housed with COVID-19 negative or asymptomatic residents, Petitioner cites to language in an April 10, 2020 COVID-19 Infection Prevention and control (IPC) preparedness checklist.  The document indicates that it was created by NYSDOH from “CDC Guidance to LTCF’s, CDC Infection Control Guidance and NYSDOH-issued Health advisories.”  The checklist states that the items on the checklist do not replace clinical judgement and are an adjunct to all available infection prevention and control guidance.  CMS Ex. 21 at 1.  Contrary to the Petitioner’s assertions, however, I find this document to further reinforce the guidance for separation of COVID-19 positive and

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negative residents.  While the document indicates that roommates of COVID-19 confirmed cases are considered exposed, the nursing facility is also directed to keep the exposed roommate in a single room for 14 days, if possible, and not be housed with an unexposed resident.  If paired with anyone, the roommate should be paired with another potentially exposed resident or someone else from the same unit.  CMS Ex. 21 at 3.  The document does not endorse or recommend that once a resident is presumed or confirmed to be COVID-19 positive, the resident remain in the room with the unconfirmed COVID-19 resident. 

In further support of the facility’s decision to presume that all residents had been exposed to COVID-19, DON Halsey points to a statement made by Dr. Emily Lutterloh with NYSDOH in an early April 2020 email exchange with Dr. Ghinwa Dumyati with the Center for Community Health and Prevention.  When asked about moving residents in the facility for cohorting, Dr. Lutterloh opined that the facility should do so if it would enhance resident safety and to not do so if there were no safety benefits.  She did not advise a facility to reject its own infectious disease guidelines or CMS/CDC guidelines.  P. Ex. 6 at 2.  While she cautioned that when COVID-19 positive patients are moved, the rooms should be left empty for a number of hours and then scrupulously cleaned and disinfected with an appropriate disinfectant, she did not advise that rooms be left vacant for days or indefinitely.  Id.  Petitioner has not demonstrated that Dr. Lutterloh’s opinion and information supersedes CMS/CDC guidelines or the facility’s existing guidelines. 

b. The Residents in Issue

Petitioner’s specific treatment of Residents 3, 4, 5, and 6 most clearly demonstrate the facility’s disregard for CDC and CMS guidelines, as well as its disregard for its own infectious control policy.  Although R4 was presumed COVID-19 positive on April 7, 2020, she remained in the room with R3 for the entire period between April 7 and April 23.  On April 23, R3 and R4 were observed in the room without masks and their privacy curtains pulled only half-way closed.  Petitioner argues that R3’s vitals and symptoms were monitored regularly for signs or symptoms of COVID-19, however, R3 never tested positive for COVID-19.  While it is fortuitous that R3 did not contract COVID-19 during this period of exposure, this outcome does not change the fact that, contrary to its policies and CDC guidelines, the facility kept an uninfected resident in proximity with an infected resident.

Despite R5’s testing positive on April 14, 2020, this resident remained in the room with R6.  Finally, on April 22, R6 ultimately tested positive.  R6’s contracting COVID-19 is perhaps the most glaring example of the safety risk posed by Petitioner’s decision to presume that all residents were potentially positive.  Leaving an asymptomatic resident closely confined with someone who is infected all but guarantees infection for both.  After eight days confined with R5, R6’s infection bears that out.

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The circumstances were slightly different for Residents 1 and 2.  There is no indication that that either resident had contracted or had been exposed to COVID-19 prior to April 22, and R2’s COVID-19 positivity was not confirmed until almost 11:00 p.m. on April 22.  Petitioner argues that because the NYSDOH surveyors involved themselves in the planning for how these residents could be cohorted, the NYSDOH delayed and slowed the process of making any sort of room change to separate R1 and R2.  P. Br. at 12.  Based on the facility’s decision to keep Residents 3, 4, 5, and 6 in shared spaces regardless of their COVID-19 status, it is very likely that R1 and R2 would have continued to share a room if the surveyors had not become involved.  The fact the surveyors took time to consult with their office to assist with finding an appropriate plan to cohort these residents is irrelevant.  The facility had in place explicit guidelines for protecting these residents, which it failed to follow. 

c. Petitioner’s Arguments Concerning Feasibility of Moving Residents

Petitioner’s second central argument is that while there may have been empty rooms in the facility, transferring residents to such rooms was not feasible or advisable under the circumstances.  P. Br. at 11.  Petitioner acknowledges that the April 2, 2020 CMS and CDC guidelines directs that LTC facilities should separate patients and residents who have COVID-19 from patients and residents who do not, or have an unknown status.  CMS Ex. 3 at 3.  Petitioner, asserts, however, that nothing in the April 2, 2020 guidelines provided specific guidance on how to manage the scenario that the facility was facing. P. Br. at 11.  Petitioner contends that while the April 2, 2020 recommendations might sound reasonable and feasible on paper, “in practice, however, it fails to recognize the overwhelming strain on the facility due to the pandemic and the unknown classification of residents in semi-private rooms who were likely already exposed to COVID-19 before their roommate tested positive.”  P. Br. at 10.  Petitioner argues that it was exercising its best efforts to comply with the river of inconsistent and conflicting policies of Federal and state health authorities regarding nursing home infection control.  P. Br. at 15. 

Essentially, Petitioner does not dispute the existing guidelines, but argues that the circumstances of the pandemic made it difficult to follow the guidelines.  There is no dispute that the period of March and April of 2020 was an unprecedented and challenging time for health care and especially for skilled nursing care to deal with the influx of the COVID-19 virus.  Because of the medical conditions of the residents, the high-density population, the use of shared rooms, the close interaction between residents and health care providers, LTC facilities were especially vulnerable.  Without a vaccine at that time, prevention requiring stringent safety precautions was essential in not only limiting the spread of the virus, but also in preventing deaths.  As CMS asserts, there were already 470,400 deaths from COVID-19 as of February 10, 2021.  CMS Br. at 8; CMS Ex. 16 at 2.

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Despite the challenges posed by this horrendous and highly contagious virus, the fact remains that CMS and CDC guidelines provided for the separation of presumed or confirmed COVID-19 positive residents from COVID-19 negative residents.  Further, Petitioner’s own infectious control policy provides for the separation of these residents.  While Petitioner acknowledges both the CDC/CMS guidelines and its own guidelines, Petitioner asserts that based upon the nature of infection in the facility, it determined to treat all residents as COVID-19 positive and to keep them isolated in their respective rooms with their existing roommates. 

d. Petitioner’s Failure to Adhere to Established Guidelines

42 C.F.R. § 483.80(a)(2) provides that a facility’s infection prevention and control program must have written standards, policies, and procedures that must include a system of surveillance designed to identify possible communicable diseases before they can spread to other persons in the facility, with standard and transmission-based precautions to be followed to prevent spread of infections, including when and how isolation should be used for a resident.  In this circumstance, the facility’s protocol for treating all residents as potentially COVID-19 positive was not a written policy that fell within the regulatory guidelines.  It was a policy that ran counter to its own internal guidelines and to the existing CMS and CDC guidelines. 

In a 2017 case, the Departmental Appeals Board (Board) addressed a situation in which a long- term care facility did not follow its own infectious disease policy or that of the CDC guidance in dealing with an influenza outbreak.  The medical director substituted his “professional judgment” in departing from the CDC guidance, as well as departing from the facility’s infection control program.  The Board rejected the facility’s argument that it could meet its regulatory obligation to follow its infection control policy by acceding to a professional judgment on the part of the medical director to not follow the policy.  Golden Living Ctr. - Superior, DAB No. 2768 at 21 (2017).  The Board also noted that they found nothing in CDC guidance to allow for any exception based on professional judgment.  Id. 

In this case, Petitioner decided to treat all residents as presumed positive rather than adhere to its own infectious disease policy or the existing policy of CMS and the CDC.  While Petitioner may have determined that this was the most efficient way to treat the increasing COVID-19 cases in its facility, Petitioner’s actions were contrary to existing policies. 

Aside from the facility’s failure to follow the existing CDC and CMS guidelines, the facility clearly disregarded its own infectious disease policy and established a protocol of treating all residents as COVID-19 positive.  The Board has long held that CMS “may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain

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residents’ highest practicable physical, mental, and psychosocial well-being, as required by section 483.25.”  N. Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008).  The record does not document the residents’ individual responses to their room assignments or their understanding of the implications for the shared room assignments.  Despite the physical risks involved, the potential stress for an asymptomatic resident to remain in a room with a presumed or confirmed COVID‑19 resident is arguably at odds with the resident’s mental and psychosocial well-being. 

CMS guidelines provide that long-term care facilities should designate separate units within a facility to separate COVID-19 negative residents from COVID-19 positive residents and residents with unknown COVID-19 status.  The facility’s own infectious disease policy that provides that residents be placed in isolation rooms in the event there are confirmed cases of an emerging infectious disease in the facility.  CMS Br. at 10-11; CMS Ex. 3 at 2-3; CMS Ex. 4 at 1, 5-6. 

Thus, by failing to separate COVID-19 positive residents from COVID-19 negative or asymptomatic residents, and specifically with its failure to separate the six residents in issue, the facility failed to comply with 42 C.F.R. § 483.80.  

B. The evidence establishes that CMS’s determination that the facility’s deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.

Citing 42 C.F.R. § 488.301, Petitioner asserts that a finding of immediate jeopardy requires that the practice or conduct at issue be the cause of an actual risk of serious injury, harm, impairment, or death to a resident. Petitioner further submits that the regulation “requires causation not mere association.”  P. Br. at 15.  

42 C.F.R. § 488.301, provides, however, that immediate jeopardy exists if a facility’s noncompliance has caused or is likely to case “serious injury, harm, impairment, or death to a resident.”  The existence of serious injury, actual harm, impairment, or death is not a prerequisite to finding immediate jeopardy level noncompliance as the regulation further provides that immediate jeopardy exists where the described adverse consequences are likely to occur.  Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff’d, Life Care Ctr. Tullahoma v. Sec'y of U.S. Dep't of Health & Human Servs.,453 F. App’x 610 (6th Cir. 2011).  

CMS’s determination as to the level of a facility’s noncompliance, which would also include an immediate jeopardy finding, must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has held that 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.  The burden is on

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the facility to show that the determination is clearly erroneous.  Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Woodstock Care Ctr., DAB No. 1726 at 9, 38 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  Thus, CMS’s determination of immediate jeopardy is presumed to be correct, and a petitioner has a heavy burden to demonstrate clear error in that determination.  Yakima Valley Sch., DAB No. 2422 at 8-9 (2011). 

Although Petitioner maintains that CMS has not established a causal relationship between the facility’s practice and any purported risk to the residents, Petitioner has not met its burden to show that CMS’s determination is clearly erroneous.  At the very least, Petitioner’s argument is refuted by the fact that R6 tested positive for COVID-19 after sharing the room with a confirmed COVID-19 positive resident for eight days.  Thus, Petitioner did not offer facts from which I can infer that CMS’s determination of immediate jeopardy is clearly erroneous. 

C. I do not have authority to grant equitable relief. 

Petitioner does not specifically request equitable relief, however, Petitioner advances a number of arguments to support its assertion that it was forced to treat all residents as potentially COVID-19 positive.  P. Br. at 8.  Petitioner submits that the facility was one of the nursing facilities in New York State that was subject to a March 24, 2020 mandate requiring nursing facilities to admit new or returning residents regardless of their COVID-19 status and without testing the residents before admission.  Id. at 4.  Petitioner also argues that the testing available at that time was also inaccurate, leading to a lack of certainty as to residents’ COVID-19 status.  Id. 

Furthermore, Petitioner contends that nothing within the April 2, 2020 CMS guidelines provided specific guidance on how to manage the scenario the facility was facing and that such guidelines were not issued until April 29, 2020.  P. Br. at 11; P. Ex. 7.  The April 29, 2020 document from the NYSDOH specifically directs that nursing care facilities to have protocols to separate residents into cohorts of positive, negative, and unknown as well as separate staffing teams to deal with COVID-positive residents and non-positive residents.  Although the April 29, 2020 publication directs facilities to develop protocols for dealing with COVID-19 positive and negative residents, it does not alter the facility’s guidelines or the CDC/CMS previous guidelines that mandate separating COVID-19 negative residents from COVID-19 positive residents and individuals with unknown COVID-19 status.  CMS Ex. 3 at 2; CMS Ex. 4 at 1.  

There is no question that the facility was dealing with an unprecedented challenge in March and April 2020.  No one can dispute the alarming speed with which the virus spread throughout the country and especially among those whose age and medical conditions made them especially vulnerable.  Nonetheless, CMS acted within its scope to find immediate jeopardy and to impose the CMP for non-compliance with 42 C.F.R.

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§ 483.80.  Accordingly, I do not have the authority to overturn its lawful use of its regulatory authority based on principles of equity.  Cent. Kan. Cancer Inst., DAB No. 2749 at 10 (2016).  More succinctly, I may not substitute my discretion because of fairness or other equitable grounds.  See James Shepard, M.D., DAB No. 2793 at 9 (2017); US Ultrasound, DAB No. 2302 at 8 (2010).  

D. The penalty imposed is reasonable.

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.  The regulations provide that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges.  42 C.F.R. §§ 488.406, 488.408.  The upper range of a CMP, $6,808 to $22,320 per day, is designated for deficiencies that pose immediate 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); 85 Fed. Reg. at 2869, 2886 (Eff. Jan. 17, 2020).  The lower range of a CMP, $112 to $6,695 per day, is designated 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(e) provides the limits for my authority to review the reasonableness of a CMP imposed by CMS.  Paramount in those limitations⁵ is the restriction that I cannot review the exercise of discretion by CMS in selecting to impose a CMP and I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  Those factors include:  (1) the facility’s history of compliance; (2) the facility’s financial condition; (3) the factors specified at 42 C.F.R. § 488.404⁶; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.

Here, CMS imposed a $9,085.00 per-day CMP for two days of immediate jeopardy, for a total of $18,170.00, which is modest considering what CMS could have imposed.  42 C.F.R. § 488.408(e)(1)(iv); see Plum City Care Ctr., DAB No. 2272 at 18-19 (2009).  Petitioner does not claim that its financial condition affects its ability to pay the CMP. CMS has not submitted evidence that Petitioner has a history of noncompliance,

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however, the immediate jeopardy deficiency here is very serious.  While the surveyors found deficiencies related to only six residents, it is undisputed that the facility’s facility-wide response to COVID-19 kept both presumed or confirmed COVID-19 positive residents housed in the room with asymptomatic or COVID-19 negative residents. 

As discussed above, CMS has established that the facility was not in substantial compliance with Medicare requirements on April 23, 2020.  Further, I find that the facility’s noncompliance with one or more requirements of participation has caused, or was likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301. 

While Petitioner does not specifically contest the amount of the CMP, Petitioner requests that CMS’s determination that the facility failed to adhere to the requirements of 42 C.F.R. § 483.80 and the imposition of the CMP for immediate jeopardy be overturned.  As discussed above, the undisputed facts demonstrate Petitioner’s noncompliance, and such noncompliance justifies CMS’s remedy determination.  The CMP imposed by CMS is at the lower end of the permissible range and reasonable in light of the seriousness of Petitioner’s noncompliance.

V.    Conclusion

For the foregoing reasons, I affirm CMS’s decision and find that the evidence establishes that the facility’s deficiency posed immediate jeopardy to resident health and safety.  The penalty imposed – $9,085.00 per day for 2 days beginning on April 22, 2020 and continuing through April 23, 2020 – is reasonable.

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Endnotes

¹ The case was initially assigned to a different ALJ and then later transferred to the undersigned.

² On June 30, 2021, Petitioner inadvertently uploaded to DAB E-file a document relating to a separate matter with the New York Department of Health.  See Docket Entry # 12 in the Departmental Appeals Board (DAB) Electronic Filing System (E-File).  On July 1, 2021, Petitioner withdrew the filing.  Docket Entry # 13 in DAB E-File.  Accordingly, this document is not considered a part of the record and has not been considered in my decision.

³ My findings of fact and conclusions of law appear as headings in bold italic type.

⁴ These statements were made by Petitioner’s employees and are undisputed.  See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010).

⁵ An additional limitation restricts me from setting the CMP at zero or reducing the CMP to zero.

⁶ The factors at 42 C.F.R. § 488.404 include:  (1) the seriousness of the deficiency, including its severity and scope; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.