Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Sunny Acres Nursing Home,
(CCN: 146068),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-21-958
Decision No. CR6460
DECISION
I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose remedies against Petitioner, Sunny Acres Nursing Home, a Medicare-participating skilled nursing facility located in Illinois, consisting of: a civil money penalty of $15,086 for each day of a period that ran from November 30, 2020 through December 3, 2020; and a civil money penalty of $435 for each day of a period that ran from December 4, 2020 through January 10, 2021.
I. Background
This case was very recently reassigned to my docket from the docket of another administrative law judge.
CMS moved for summary judgment and Petitioner opposed the motion. I find it unnecessary to decide whether there are undisputed material facts that justify CMS’s remedy determination and, therefore, I do not issue summary judgment. I decide this case based on the parties’ written exchanges, including their evidence submissions. I find no need to convene an in-person hearing.
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At the inception of this case, the administrative law judge to whom it was first assigned issued an order establishing the rules that addressed, among other things, the exchange by the parties of briefs and exhibits. Standing Pre-hearing Order of Administrative Law Judge Leslie C. Rogall for Cases Involving Compliance With Health, Safety, and Quality Standards (Standing Order). Paragraph 11 of the Standing Order directs the parties to reduce all proposed testimony to writing made under oath or as a declaration made under penalty of perjury. Paragraph 12 addresses possible cross-examination of witnesses, stating:
A request for cross-examination must be in the form of a notice that is filed separately from a brief. A request for cross-examination must list the specific witness(es) and must indicate the anticipated amount of time that will be required for cross-examination of each witness.
The parties filed pre-hearing exchanges. Petitioner’s exchange included the written direct testimony of several witnesses. CMS did not file a request to cross-examine any of them. Petitioner did not file a notice that specifically requested cross-examination of CMS’s witness. Instead, it included this statement in its list of witnesses and exhibits:
The Facility may cross-examine any witness disclosed by CMS. Testimony will be to expand upon, clarify or complete any testimony elicited by CMS.
Sunny Acres Nursing Home Lists of Proposed Exhibits and Witnesses at 3.
Petitioner’s statement does not comply with the requirements of the Standing Order. It is not a definite statement of intent to cross-examine, but rather, it is a statement that Petitioner might cross-examine a witness. It does not specify the anticipated amount of time that will be required for cross-examination.
The purpose of the Standing Order is to narrow the focus of any hearing that may be conducted in the case and to enable the administrative law judge to plan for the possible length of the hearing.1 Petitioner’s response to the Standing Order addresses neither purpose. It is an open-ended statement by Petitioner’s counsel of what she might do in the event of an in-person hearing.
I conclude that Petitioner surrendered its right to conduct cross-examination when it failed to comply with the Standing Order. There is no need for me to convene an in-
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person hearing in this case because neither CMS nor Petitioner filed a request to cross-examine witnesses in compliance with the Standing Order.2
CMS filed exhibits identified as CMS Ex. 1 – CMS Ex. 26 in support of its case. Petitioner filed exhibits identified as P. Ex. 1 – P. Ex. 22. Neither party filed objections to my receiving exhibits. I receive the parties’ exhibits into evidence.
II. Issues, Findings of Fact and Conclusions of Law
A. Issues
The issues are whether Petitioner failed to comply substantially with a Medicare participation requirement, whether CMS’s determination of immediate jeopardy level noncompliance is clearly erroneous, and whether CMS’s remedy determination is reasonable.
B. Findings of Fact and Conclusions of Law
1. Noncompliance
At issue in this case is Petitioner’s compliance with 42 C.F.R. § 483.80, a regulation that is commonly known as the “infection control regulation.”3 The regulation imposes on every Medicare-participating skilled nursing facility the duty to establish and implement an infection prevention and control program that is designed to provide a safe, sanitary, and comfortable environment to help prevent the transmission of communicable diseases and infection. Park Manor Nursing Home, DAB No. 2005 at 38 (2005). Among other things, the regulation directs skilled nursing facilities to develop and implement an infection prevention and control program that includes:
A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a
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contractual arrangement based upon the facility assessment . . . and following accepted national standards[.]
42 C.F.R. § 483.80(a)(1).
A skilled nursing facility must develop written standards and policies and procedures that include, among other things: “Standard and transmission-based precautions to be followed to prevent spread of infections[.]” 42 C.F.R. § 483.80(a)(2)(iii). These standards, policies and procedures become a facility’s infection prevention and control policy. Failure by a facility to implement its own policy violates the infection control regulation. Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13 (2014).
CMS alleges that Petitioner failed to comply with the infection control regulation in late 2020 and early 2021, a time when the pandemic caused by the COVID-19 (“Covid”) virus was at a peak in this country. Centers for Medicare & Medicaid Services’ Combined Pre-Hearing Brief and Motion for Summary Disposition (CMS’s brief) at 13.
Covid is a respiratory virus that can have lethal consequences for elderly and infirm individuals. Centers for Disease Control and Prevention, About COVID-19 (July 10, 2023), https://www.cdc.gov/coronavirus/2019-ncov/your-health/about-covid-19.html. Nursing facility residents are particularly susceptible to Covid and its consequences, due in part to their age and conditions, but due also to the fact that in nursing facilities residents live in close contact with each other. CMS Ex. 24 at 2. There may be disastrous consequences when Covid invades a nursing facility. As of the end of 2020, deaths of nursing facility residents from Covid accounted for nearly 40 percent of Covid fatalities in this country. Gregg Girvan, Nursing Homes & Assisted Living Facilities Account for 38% of COVID-19 Deaths (January 30, 2021), https://freopp.org/the-covid-19-nursing-home-crisis-by-the-numbers-3a47433c3f70.
The lethality of Covid in the nursing facility population and its easy transmissibility imposes a heavy burden on skilled nursing facilities, such as Petitioner, to scrupulously comply with their infection control policies and with infection control criteria published by the Centers for Disease Control and Prevention (CDC) and by state health care agencies.
Petitioner developed a policy to deal with Covid. CMS Ex. 19; CMS Ex. 20. That policy acknowledged guidance issued by agencies, including CMS, CDC, the Illinois Department of Public Health (IDPH), and local health agencies. It stated that Petitioner would ensure that its actions were up to date and in compliance with the guidelines issued by these entities. CMS Ex. 19 at 4, 21. Petitioner recognized the continually evolving national standards that were being issued to adapt to and confront the pandemic, noting that protocols issued by the CDC and IDPH were subject to daily change. Id. at 21.
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Petitioner stated that residents infected with Covid should be isolated to a single unit within its facility. CMS Ex. 19 at 5-6. Petitioner announced that it would segregate its residents according to their Covid status. Infected residents would be housed in a “red zone” within Petitioner’s facility. Potentially infected residents or residents whose status was unknown would be housed in a “yellow zone.” Uninfected residents would be housed in a “green zone.” CMS Ex. 20 at 2.
Petitioner instructed that staff who worked with Covid-infected residents should not be assigned to work with uninfected or asymptomatic residents. Id. at 3.It announced that it would create a dedicated Covid care team and that it would make every effort to use only that staff to care for infected residents. Id.
CMS asserts that Petitioner failed to comply with its own infection control policy and with guidelines issued by the CDC. CMS’s brief at 13-18. The evidence supports CMS’s contentions.
Covid invaded Petitioner’s facility beginning in early November 2020. CMS Ex. 13 at 1. Between November 8 and December 1, 2020, 28 of Petitioner’s residents were infected. Id. at 1-2. Petitioner responded to the spread of infection by “cohorting” its residents – that is, segregating residents according to their Covid status. It walled off the south wing of its facility as a site for its infected residents and for residents whose infection status was unknown. However, one hallway in that part of that facility remained dedicated to uninfected residents. CMS Ex. 18. Consequently, the south wing of Petitioner’s facility housed uninfected residents, residents whose status was unknown, and infected residents.
Petitioner violated its policy that a staff member who treated Covid-infected residents should not be assigned to treat residents who were of unknown or uninfected status. Throughout November and into December 2020, during night shifts, it assigned a single nurse to care for all of the residents in the south wing – infected, uninfected, and of unknown status. CMS Ex. 17 at 8-32. This was a continuation of a practice that predated the Covid infection. Id. at 7. That violation is noncompliance with the infection prevention and control regulation. Heritage House, DAB No. 2566 at 12-13.
This was a serious violation, not something technical or trivial. Petitioner acknowledged that CDC and IDPH guidelines directed that staff be segregated so that they did not care for both infected and uninfected residents. CMS Ex. 19 at 6. The reason for not allowing staff to care for both the infected and uninfected is obvious. By segregating staff, a facility eliminates a possible avenue of transmission of a lethal illness. On the other hand, staff who travel between infected and uninfected residents may serve as infection vectors.
I have considered Petitioner’s arguments, and I find them to be without merit.
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Petitioner does not deny that it assigned one nurse to treat all of the residents in its south wing. It argues that it did the best it could. It “establish[ed] zones and at all times ‘possible’ maintained dedicated staff in these areas of the facility.” Petitioner, Sunny Acres Nursing Home, Pre-hearing Brief and Response to CMS’s Combined Pre-hearing Brief and Motion for Summary Judgment (Petitioner’s brief) at 13.
But Petitioner fails to address the evidence presented by CMS. Petitioner offered no evidence to show that it ever assigned nurses during its night shift so that a dedicated nurse treated only infected, and not uninfected, residents. Thus, from Petitioner’s perspective, segregating staff “at all times ‘possible’” meant never. Petitioner’s brief at 13.
Petitioner asserts that there was a shortage of nursing staff during the Covid pandemic. It contends that this:
quickly rose to a critical shortage in our Country and State as a result of the Pandemic. Agency staffing companies and healthcare providers could not obtain sufficient staff. Sunny Acres was competing with two major medical centers/hospitals in Springfield, Illinois (22.9 miles away by car) as well as numerous other [long term care] Facilities in bordering counties and multiple other health provider disciplines. Eventually the nursing shortage continued but it became a staffing shortage for the Facility.
Petitioner’s brief at 10 (citations omitted).
I do not take issue with Petitioner’s contention that it was difficult to hire and retain nurses in 2020. But that problem does not axiomatically yield a conclusion that Petitioner was unable to assign dedicated nurses to treat its infected residents in November and December of that year. Petitioner produced no documentation to show that it even considered assigning dedicated nurses much less that it addressed possible difficulties with doing so. There is no evidence to show that Petitioner’s management concluded that assigning dedicated nurses to treat infected residents was impossible.
I have considered the affidavit submitted by Petitioner’s administrator, Sarah Hoskins. P. Ex. 16. Ms. Hoskins discusses at length the staffing problems that Petitioner faced in 2020. But she does not aver at any part of her affidavit that it would have been impossible for Petitioner to assign dedicated nurses to deal only with infected residents. Nor does she explain the fact that Petitioner’s assignment to its south wing of one nurse during the night shift – a practice that predated the onset of Covid in Petitioner’s facility – continued unchanged throughout November and early December 2020, after Covid had invaded Petitioner’s facility and Petitioner had established a “red zone” in the south wing to house infected residents.
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Petitioner asserts that it was told by an IDPH representative, Karen Trimberger, that assigning dedicated staff to treat infected residents was not mandatory. It cites this statement that Ms. Trimberger made in an e-mail:
If able to provide a dedicated staff, that’s ideal but it is not mandated to do so. Staff must ensure they follow transmission-based precautions and not misuse PPE [personal protective equipment] as to transmit from potentially exposed residents to the COVID negative residents.
CMS Ex. 11 at 31.
Petitioner misrepresents what Ms. Trimberger said and her statement’s bearing on Petitioner’s practices.
The e-mail chain of which Ms. Trimberger’s statement is a part makes it clear what Ms. Trimberger was talking about and what she said was permissible. On December 13, 2020, someone writing on behalf of Petitioner asked whether Petitioner’s “yellow zone” – a part of the south wing reserved for residents whose infectious state was unknown – required dedicated staff. On December 14, and in response, Ms. Trimberger addressed the staffing arrangement for those residents. She did not address the need for dedicated staff to deal with infected residents. Nothing in her e-mail response, made on December 14, 2020, suggests that Petitioner could eliminate dedicated staff for those residents. CMS Ex. 11 at 31.
Furthermore, and as I have noted, the e-mail exchange occurred on December 13 and 14, 2020. That was weeks after Petitioner systematically violated its own policy by failing to assign dedicated staff to treat its infected residents. Petitioner cannot credibly claim that it relied on Ms. Trimberger’s advice.
Petitioner asserts that CDC and IDPH guidance on staffing merely consisted of recommendations, seemingly contending that it was free to ignore that guidance. Petitioner’s brief at 14. But the guidance was more than recommendations that Petitioner was free to follow or ignore as it chose. Petitioner’s policy stated that it would follow CDC and IDPH guidance. CMS Ex. 19 at 4, 21. It effectively made current guidance from these agencies a part of its own policy. Having done so it could not simply ignore that guidance.
Petitioner asserts that CMS’s entire case for finding that Petitioner failed to assign dedicated nurses to treat its infected residents is premised on an isolated incident in which a registered nurse went from Petitioner’s “green zone” housing uninfected residents to the “red zone” housing infected residents in order to provide necessary care to a resident. Petitioner’s brief at 6. That argument is incorrect. CMS bases its allegations on
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Petitioner’s record of nurse assignments, a record that Petitioner does not dispute. CMS Ex. 17.
Finally, I have considered the affidavit of Kelly Smith, R.N. P. Ex. 18. In her affidavit, Ms. Smith contends that each zone in the south wing had a nurse or nursing staff as was required by CDC guidelines. Id. at 2. Her use of the word “or” renders her statement ambiguous. However, I find her assertion not credible if she intended by it to say that each zone in Petitioner’s south wing had a dedicated nurse assigned to it during Petitioner’s night shift. That is belied by Petitioner’s own records. CMS Ex. 17.
As a second allegation of noncompliance with the infection control regulation, CMS alleges that Petitioner allowed a Covid-infected employee to return to work prematurely in violation of Petitioner’s policy and CDC guidance. CMS’s brief at 18. The evidence substantiates this allegation.
Petitioner’s policy governing return to work of Covid-infected staff stated that a staff member who manifested mild to moderate Covid symptoms would not return to work until symptoms had improved, at least 10 days had elapsed since symptoms first appeared, and at least 24 fever-free hours had passed without the use of fever-reducing medication. CMS Ex. 19 at 15-16. Petitioner’s policy duplicates CDC guidance. CMS Ex. 24 at 17-18.
Petitioner violated its policy as well as CDC guidance. A staff member, Mary Ellen Cremeens, reported that she had tested positive for Covid on November 18, 2020. CMS Ex. 11 at 34. She averred that she became symptomatic on November 25, 2020, with a cough, headache, nasal drainage, and muscle aches. She became fever-free for 24 hours on November 30. Id. She returned to work on December 1, 2020, only six days after her Covid symptoms first appeared.
The guidelines about return to work obviously existed for a reason. At the time, the CDC had drawn conclusions based on available evidence about when an infected individual ceased to be contagious. The parameters drawn by the CDC – and adopted by Petitioner – were intended to eliminate the risk that an individual might continue to transmit the disease even after having more or less recovered. Petitioner had no justification for ignoring those parameters in Ms. Cremeens’ case.
Petitioner contends that Ms. Cremeens returned to work after she had been fever-free for more than 24 hours. Petitioner further contends that Ms. Cremeens’ symptoms were resolved on November 28, and that CDC guidance only required that 10 days elapse after an employee’s positive test date or date symptoms began. That, according to Petitioner, meant that she could work consistent with CDC guidance and Petitioner’s policy. P. Ex. 16 at 2; P. Ex. 17 at 1-2.
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This argument misreads CDC guidance and Petitioner’s policy. The guidance and policy did not allow Petitioner to elect to return infected employees to work based solely on their having been fever-free for 24 hours or more. The policy and guidance required that infected employees be fever-free and that at least 10 days had elapsed since Covid symptoms first appeared (rather than the positive test date). CMS Ex. 19 at 15-16; CMS Ex. 24 at 17-18. Ms. Cremeens was fever-free for more than 24 hours when she returned to work on December 1, 2020. But, it had been only six days since she first became symptomatic for Covid on November 25, 2020. CMS Ex. 11 at 22. That necessitated at least four additional days of self-isolation before she could return to work.
Petitioner asserts that another employee, identified as V6, returned to work in accord with Petitioner’s Covid policy and CDC guidelines. Petitioner’s brief at 19. However, CMS does not allege that V6 returned to work in violation of Petitioner’s guidelines or CDC policy. See CMS’s brief.
CMS makes a third allegation of noncompliance, asserting that Petitioner’s failure to test a feverish resident, identified as R1, for Covid was a violation of Petitioner’s policy. CMS’s brief at 7. I find it unnecessary to address this allegation in order to conclude that Petitioner violated the infection prevention and control regulation.
2. Immediate Jeopardy
CMS determined that Petitioner’s noncompliance with the requirements of 42 C.F.R. § 483.80 was so egregious as to comprise immediate jeopardy for residents of Petitioner’s facility. Regulations define immediate jeopardy as noncompliance that causes or is likely to cause a resident or residents of a facility to experience serious injury, harm, impairment, or death. 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 Commons Nursing & Rehab Ctr., - Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007).
Petitioner’s noncompliance endangered residents. As I have discussed, Covid is frequently lethal among a population of elderly and infirm individuals. Petitioner’s failure to comply with its own infection control requirements increased the odds that Covid would spread within its facility.
Petitioner asserts that CMS failed to prove that its noncompliance supports a finding of immediate jeopardy. Petitioner’s brief at 5. That assertion misstates the parties’ burdens. CMS is not under a duty to prove that Petitioner’s noncompliance amounts to immediate
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jeopardy. Rather, it is Petitioner’s burden to prove that CMS’s determination is clearly erroneous.
Petitioner argues that, as of November 2020, it had not been advised, either by CDC or IDPH, that Covid was an airborne infection. Petitioner’s brief at 5. This assertion is irrelevant. Petitioner certainly knew by November 2020 that Covid was highly infectious and that it was potentially lethal in skilled nursing facilities. Petitioner also knew that Covid had wreaked havoc in other facilities. And Petitioner either knew or should have known that scrupulous adherence to infection control protocol was critical protection for its residents.
Petitioner also contends that there is no evidence that it committed a willful act that allowed Covid to enter its facility. Petitioner’s brief at 5. That contention also is irrelevant. Noncompliance with the infection control regulation may put residents at immediate jeopardy whether or not it is willful.
3. Remedy
The remedy that CMS determined to impose against Petitioner consists of civil money penalties of: $15,086 for each day of a period that began on November 30, 2020, and that continued through December 3, 2020; and $435 for each day of a period that began on December 4, 2020, and that continued through January 10, 2021.4 The larger penalty amount addresses the days when CMS determined Petitioner’s noncompliance to be at the immediate jeopardy level. The smaller amount addresses a period during which CMS found that Petitioner’s noncompliance continued, but at a level that was less than immediate jeopardy.
Regulations authorize CMS to impose per-diem civil money penalties for both immediate jeopardy level and non-immediate jeopardy level noncompliance. 42 C.F.R. § 488.438(a)(1). In assessing the reasonableness of any civil money penalty, one looks to regulatory factors that govern penalty amounts. These factors may include the seriousness of a facility’s noncompliance, its culpability, its compliance history, and its financial condition. 42 C.F.R. §§ 488.438(f)(1)-(4), 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).
The regulations establish ranges that describe minimum and maximum amounts for both immediate jeopardy and non-immediate jeopardy level penalties. 42 C.F.R.
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§ 488.438(a)(1); 45 C.F.R. Part 102 (penalty amounts are adjusted annually to account for inflation). The penalties that CMS imposed against Petitioner are relatively modest. The immediate jeopardy level penalty is slightly above the mid-point of the then-permissible range for such penalties (from $6,808 to $22,320). The non-immediate jeopardy level penalty is near the bottom of the then-permissible range for such penalties ($112 to $6,695). 85 Fed. Reg. 2869, 2879-2880 (Jan. 17, 2020).
CMS asserts that the penalty amounts are justified based on the seriousness of Petitioner’s noncompliance, its culpability, and its compliance history. CMS’s brief at 20-21. I find that the evidence supports CMS’s determination.
Petitioner’s noncompliance was extremely serious. I need not reiterate the dangers that Covid poses to nursing facility residents except to say that Covid is often a death sentence for these individuals. Petitioner’s failure to follow its own infection prevention and control plan put its residents at risk for contracting a lethal illness.
I also find that Petitioner was culpable for its noncompliance. As I have concluded, Petitioner offered no credible explanation for its failure to implement its plan to provide dedicated staff for its Covid-infected residents. I accept Petitioner’s assertion that it confronted staffing issues in late 2020. But staffing problems did not provide Petitioner an excuse to ignore its policy. The record fails to show any effort by Petitioner to maintain dedicated nurses in its “red zone.”
Finally, CMS has offered evidence to show that Petitioner has a poor compliance history predating the events of November and December 2020. CMS Ex. 3 at 1-3. That includes previous noncompliance with the infection control regulation. Id.
Petitioner asserts that the remedies that CMS imposed were excessive. Petitioner’s brief at 21. However, it has not offered evidence that specifically rebuts CMS’s determination, aside from arguing that it complied at all times with regulatory requirements, an argument that I have rejected in this decision. It has not specifically challenged CMS’s determination of penalty amounts. It has not offered evidence that directly targets CMS’s findings of culpability and Petitioner’s compliance history. Nor has it challenged CMS’s determination of the duration of noncompliance. In sum, Petitioner has not offered evidence that directly rebuts CMS’s remedy determination.
Endnotes
1 I am very familiar with the purpose of the Standing Order as a case management tool. I issue nearly identical standing orders in cases assigned to my docket. I take notice that most of the other administrative law judges who serve at the Departmental Appeals Board also issue identical, or nearly identical, standing orders in the cases assigned to them.
2 CMS’s witness is an employee of the Illinois State survey agency who visited Petitioner’s facility beginning December 7, 2020. CMS Ex. 7; CMS Ex. 25. The surveyor’s testimony largely repeats or refers to the contents of Petitioner’s records. I find it unnecessary to rely on the surveyor’s testimony or her reports to decide this case. I base my findings of fact on Petitioner’s records and on the evidence offered by Petitioner.
3 I apply the version of the regulation that was in effect in 2020. The regulation subsequently has been amended.
4 CMS also imposed a two-year ban on Petitioner conducting a nurse aide training, competency, and evaluation program (NATCEP). That determination would be justified by my sustaining the CMP. However, the issue of CMS’s authority to impose a NATCEP ban has been rendered moot by the passage of more than two years from the date of CMS’s determination.
Steven T. Kessel Administrative Law Judge