Trinity Care Center, DAB CR6459 (2024)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty of $12,850 for each day of a period beginning on April 25, 2020, and ending on April 30 of that year, against Petitioner, Trinity Care Center.  I base my decision on evidence establishing that Petitioner, a Texas skilled nursing facility, failed to comply substantially with a Medicare participation requirement and that its noncompliance was so egregious as to put residents of Petitioner’s facility in immediate jeopardy.

I. Background

This case was assigned originally to another administrative law judge.  It was very recently reassigned to me.

The parties filed briefs and exhibits.  They agreed to waive an in-person hearing, allowing this case to be decided based on their written submissions.  CMS filed exhibits that are identified as CMS Ex. 1 – CMS Ex. 14.  Petitioner filed exhibits that are identified as P. Ex. 1 – P. Ex. 49.  Petitioner objected to my receiving many of CMS’s

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exhibits into evidence.  I overruled Petitioner’s objections and admitted the parties’ exhibits into evidence.  Ruling Receiving Exhibits in Evidence, March 21, 2024.

I have reviewed the entire record and base my decision on the parties’ exhibits and arguments.

II. Issues, Findings of Fact and Conclusions of Law

1. Issues

The issues in this case are whether Petitioner failed to comply substantially with a Medicare participation requirement, whether any noncompliance by Petitioner was so egregious as to put residents of its facility in immediate jeopardy, and whether CMS’s remedy determination is reasonable.

2. 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.”¹  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 and to help prevent the development and transmission of communicable diseases and infections.  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 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, 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).  The regulation further directs a skilled nursing facility to determine when and how isolation should be used for a resident.  42 C.F.R. § 483.80(a)(2)(iv). 

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CMS’s noncompliance allegations address a time when Petitioner, along with many other skilled nursing facilities, was grappling with infections of the Covid-19 (“Covid”) virus.  Covid is a highly infectious illness that is easily transmitted by airborne particles. 

Covid is an illness that can be fatal.  Nursing facility residents are especially susceptible to Covid’s ravages.  CMS Ex. 5 at 11.  A Covid infection often is a death sentence for an elderly and infirm individual who grapples with other medical issues, precisely the sort of individual who resides in a skilled nursing facility.  It is undisputed that in the spring of 2020, Covid wreaked havoc in our society in general and especially in skilled nursing facilities.  In 2020, at the height of the Covid pandemic, deaths among Medicare patients in nursing homes increased by more than 169,000 over the previous year, a 32 percent increase.  https://apnews.com/article/nursing-homes-coronavirus-pandemic-pandemics-business-health-f1a44187198ccca1e4311ac72f4f42aa. 

The Covid pandemic imposes a burden on skilled nursing facilities to exercise vigilance and to take every reasonable measure to protect their residents against becoming infected.  CMS alleges that Petitioner failed to meet this burden.  It alleges that Petitioner failed to assure that residents, including those who were demented, who had tested positive for Covid were not in contact with uninfected residents.  CMS argues that allowing these residents to mingle facilitated the spread of the disease, putting residents at risk for illness and possibly, death.  It contends that: 

• On April 25 and 26, 2020, state agency surveyors who were in Petitioner’s Covid unit observed residents, including one who was demented, who had tested positive for Covid in a common area, without wearing masks.  Staff were not observed redirecting these residents either to return to their rooms or to don masks.  CMS Ex. 1 at 9; CMS Ex. 3 at 50, 53, 56.
• On April 25, 2020, surveyors in Petitioner’s secure unit observed residents with dementia dining at four different tables, all seated within an arm’s length of each other.  CMS Ex. 1 at 11; CMS Ex. 3 at 5.  When questioned, Petitioner’s director of nursing acknowledged that some of these residents had tested negative for infection with Covid.  CMS Ex. 1 at 11-12; CMS Ex. 3 at 5.  The director of nursing stated that the residents who were dining together did so because of their tendency to wander.  Id.
• On April 27, surveyors observed two Covid-positive residents (identified as Residents 2 and 3), one of whom was demented (Resident 2), in Petitioner’s common area for a third consecutive day without wearing masks.  CMS Ex. 1 at 9-10; CMS Ex. 3 at 61.  Staff did not attempt to redirect these residents or to persuade them to wear masks.  CMS Ex. 1 at 10; CMS Ex. 3 at 61.

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The evidence supports these allegations.  Residents were needlessly exposed to infected residents, heightening the likelihood that Covid would spread within Petitioner’s facility.  Petitioner’s failure to protect these residents violated Petitioner’s own policy as well as the guidelines for dealing with Covid then in effect.

Petitioner’s Covid policy, adopted in March 2020, stated that:

Facility leadership and clinical team are implementing all reasonable measures to protect the health and safety of residents and team during the current outbreak of coronavirus disease (COVID-19) . . . . The response to the current outbreak of coronavirus disease is based on the most current recommendations from health policy officials, state agencies and the federal government . . . . Current CDC [Centers for Disease Control and Prevention] guidelines will be followed for infection prevention and control of residents diagnosed with COVID-19 . . . .

CMS Ex. 7 at 1, 3 (emphasis added).

CDC guidelines that were current in April 2020 included guidance for caring for demented residents during the pandemic.

Routines are very important for residents with dementia.  Try to keep their environment and routines as consistent as possible while still reminding and assisting with frequent hand hygiene, social distancing, and use of cloth face coverings (if tolerated).  Cloth face coverings should not be used for anyone who has trouble breathing, or is unconscious, incapacitated, or otherwise unable to remove the mask without assistance. . . . Continue to provide structured activities which may need to occur in the resident’s room or be scheduled at staggered times throughout the day to maintain social distancing.  Provide safe ways for residents to continue to be active, such as personnel walking with individual residents around the unit or outside.  Limit the number of residents or space residents at least 6 feet apart as much as feasible when in a common area, and gently redirect residents who are ambulatory and are in close proximity to other residents or personnel.

CMS Ex. 5 at 112 (emphasis added) (CDC, Considerations for Memory Care Units in Long-term Care Facilities).  Petitioner’s staff did not attempt to have its residents, including those who were demented, wear masks, nor did it attempt to redirect them when they wandered, Petitioner’s policy and CDC guidance notwithstanding.  Surveyors observed maskless Covid-positive residents on three consecutive days wandering unattended in a unit that housed both Covid-positive residents and other residents who had not tested positive for infection.  The surveyors observed no interventions by staff.

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Staff did not attempt to socially distance residents in the secure unit when they were dining.  Residents were seated within arm’s length of each other. 

The CDC guidance acknowledges that it may be difficult to induce demented residents to wear masks or to prevent them from wandering.  However, Petitioner offered no evidence to show that its staff attempted but failed to have the residents wear masks, nor did it attempt to prove that its staff tried but failed to redirect its Covid-positive and wandering demented residents.  Petitioner offered no credible explanation for its staff’s failure to socially distance residents at mealtime. 

Petitioner argues that it should not be held liable for its failure to enforce CDC guidance because this guidance was not published as a regulation and therefore, lacks the force of law.  Petitioner’s Amended Pre-hearing Brief (Petitioner’s brief) at 4-5.  This argument fails, first, because Petitioner violated its own policy stating that it would attempt to prevent or limit infections in its facility by adhering to CDC guidance.  CMS Ex. 1 at 17; CMS Ex. 7 at 3. 

Additionally, Petitioner’s argument fails because Petitioner has not attempted to show that the CDC guidance was incorrect.  It has not offered any evidence that proves that failure to follow the guidance was either harmless to residents or provided them with better protection than that which the CDC recommended.  Indeed, Petitioner has not denied that the CDC guidance concerning care of demented residents constituted “acceptable national standards” for dealing with Covid in April 2020.  42 C.F.R. § 483.80(a)(1). 

Petitioner asserts that it cannot be held responsible for adhering to CDC guidance because that guidance changed constantly during the spring of 2020.  Petitioner’s brief at 5-6.  It asserts:  “Constantly revised guidance does not provide Petitioner with adequate notice of the legal criteria to which it was being held accountable in April and May 2020.”  Id. at 5. 

This argument is a red herring.  Petitioner has not identified any CDC guidance relating to care of demented residents during April or May 2020 that conflicts with the guidance in Considerations for Memory Care Units in Long-term Care Facilities (CMS Ex. 5 at 112) that I have cited.  In fact, it has not offered any contrary guidance from any source. 

Petitioner asserts that in April 2020, the state agency advised nursing facilities that they should monitor residents for signs and symptoms of Covid three times a day.  But, according to Petitioner, at the same time the CDC advised that residents should be monitored once a day.  Id. at 6. 

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This argument is another red herring.  CMS does not allege that Petitioner failed adequately to monitor its residents for signs and symptoms of Covid.  Any possibly conflicting guidance about how often to monitor is irrelevant to this case. 

Petitioner acknowledges that the infection control regulation requires it to follow accepted national standards.  Petitioner’s brief at 9.  But, according to Petitioner, that language is meaningless because the regulation does not identify the precise accepted national standards that a skilled nursing facility must follow.  Petitioner asserts that the regulation, albeit lengthy:  “does not contain any directive or requirement that nursing facilities follow CDC or state agency guidance.”  Id. at 8.  It contends, therefore, that it cannot be held liable for violating the regulation based on its failure to follow CDC guidance. 

But Petitioner does not deny that the CDC is an agency that publishes national guidance addressing infectious diseases.  Indeed, the purpose of the CDC is to give guidance that may be applied nationally.  Furthermore, Petitioner’s own policy defines CDC guidance as a standard that it will follow.  Petitioner cannot now deny its duty to follow CDC guidance when its own policy states precisely that it will follow that guidance. 

Of course, and as a practical matter, it would be impossible for CMS to publish a regulation that lists every national standard for dealing with infections.  Covid is not the only infection that a skilled nursing facility must confront and, as Petitioner correctly points out, CDC guidance evolves with ongoing knowledge about Covid or any other disease, for that matter.  The regulation imposes on skilled nursing facilities the duty to keep abreast of evolving national standards, a duty that Petitioner acknowledges in its policy.  As I have discussed, Petitioner might have an argument if it identifies conflicting national standards that bear on its response to the Covid epidemic.  It has not done so.  

Petitioner defends against its failure to socially distance its residents in its secure unit by contending that when it initially received Covid test results for those residents, only two tested positive.  Petitioner’s brief at 15.  It asserts that it immediately transferred these residents from the unit, thereby leaving behind only residents who had tested negative.  Id.  From this, it seems to argue that there was no harm in failing to socially distance the remaining residents of the unit. 

Petitioner is incorrect in asserting that its dementia unit was free of Covid when the surveyors observed it on April 25, 2020.  Moreover, the Covid-positive residents who were observed by the surveyors had confirmed diagnoses of infection that predated the surveyors’ observations.  CMS Ex. 3 at 50, 53, 56. 

Petitioner’s assertion that its dementia unit residents were free of Covid when observed by the surveyors is irrelevant.  As Petitioner concedes, the Covid virus had invaded its facility in late April 2020.  The possibility that any resident might be infected imposed on

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Petitioner the duty to make its best efforts to have its residents wear masks, to redirect them when they wandered, and to socially distance them in common areas. 

Petitioner also argues, apparently without recognizing the contradiction with its claim that all but two of the residents in the secured unit had tested negative for Covid, that attempts to have its residents wear masks, and to socially distance them when they dined, would have been pointless because all residents on the unit had already been exposed to the Covid virus.  Petitioner’s brief at 15-16.  But the fact that the residents had been exposed – if true – did not relieve Petitioner of its duty to protect them.  Potentially infected isn’t congruent with infected.  Some of these residents might have avoided infection had they been protected.  

CMS makes additional allegations of noncompliance, asserting that: 

• Surveyors observed Petitioner’s staff failing to sanitize a blood pressure cuff between taking blood pressure readings of residents.  CMS Ex. 1 at 13-14; CMS Ex. 3 at 61, 83.  This occurred, despite an acknowledgment by a medication aide that she had been trained to sanitize the cuff between uses.  CMS Ex. 1 at 13; CMS Ex. 3 at 61.
• Surveyors observed disposable gowns in residents’ rooms that were commingled with other gowns, allowing for possible cross-contamination by the Covid virus.  CMS Ex. 1 at 6, 7; CMS Ex. 3 at 56.

The evidence sustains these allegations.  They are supported by the testimony of surveyors who personally observed the performance and activities of Petitioner’s staff.  I find the surveyors’ observations to be credible.  The surveyors’ findings about commingling of protective gowns are, moreover, supported by photographic evidence.  CMS Ex. 3 at 51, 52. 

Petitioner acknowledges that its staff failed to sanitize equipment properly in between uses.  It asserts that these failures were “isolated” instances that do not demonstrate noncompliance.  Petitioner’s brief at 16.  It argues that:  “the risk of contamination from surface transmission is very low.”  Id.  But Petitioner does not deny that there is at least some risk of infection from contact with virus on surfaces.  That risk looms large in a skilled nursing facility, considering the danger that Covid infection poses to the facility’s residents. 

Petitioner admits that its staff commingled protective gowns by hanging gowns on the same hook.  Petitioner’s brief at 12.  It argues that this practice was of no consequence, because:  “each resident on the unit already had COVID or had been exposed to the virus.”  Id.  But being exposed to Covid is not synonymous with being infected by it.  Petitioner cannot credibly deny that the commingling of gowns increased the likelihood

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of residents being exposed to the virus and concomitantly, increased their chances of becoming infected. 

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 failed to prove CMS’s determination was clearly erroneous.  It asserts that:  “The testimonial and documentary evidence will establish by a preponderance of the evidence that CMS’ determination of Immediate Jeopardy was clearly erroneous because Petitioner was in substantial compliance . . . .” Petitioner’s brief at 24-25. 

However, aside from denying its noncompliance, Petitioner has pointed to no evidence that shows that CMS’s immediate jeopardy determination was clearly erroneous.  Petitioner has not overcome the presumption that its residents were in immediate jeopardy. 

In fact, the evidence in this case very strongly supports a finding of immediate jeopardy level noncompliance.  CMS proved that Petitioner failed to implement its own infection control policy to prevent the spread of Covid within its facility.  That is enough to establish immediate jeopardy level noncompliance.  As I have discussed, Covid is often lethal when it invades a skilled nursing facility.  Any deficiency by a facility that increases the risk that residents might contract this frequently lethal disease creates a likelihood that some residents will suffer serious injury, harm, impairment, or death.  

3. Remedy

The remedy that CMS determined to impose against Petitioner, a civil money penalty of $12,850 per day for each day of a period beginning on April 25 and continuing through April 30, 2020, is amply supported by the evidence and is reasonable. 

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Regulations authorize CMS to impose per-diem civil money penalties for 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. § 488.438(a)(1), 45 C.F.R. Part 102 (penalty amounts are adjusted annually to account for inflation).  The penalty that CMS imposed against Petitioner is relatively modest, falling at about the mid-point of the permissible range for immediate jeopardy level penalties.  

I find that the seriousness of Petitioner’s noncompliance supports the penalty determination.  Petitioner’s lax enforcement of its infection control policy put residents at jeopardy for contracting a lethal disease.  That laxity could well have been a death knell for one or more residents. 

Petitioner asserts that the penalty amount is unreasonable.  Petitioner’s Request for Hearing; Petitioner’s brief at 25-26.  It argues, first, that no remedy should be imposed because it complied with participation requirements.  I need not reiterate my noncompliance findings here to conclude that this argument is unsupported. 

Second, Petitioner asserts that in making its remedy determination CMS failed to account for the seriousness of Petitioner’s noncompliance, its compliance history, and its level of culpability.  As I read Petitioner’s argument, it is saying that CMS must check off all of the regulatory elements governing the penalty amount before making a remedy determination.  I disagree. 

The criteria for determining the penalty amount at 42 C.F.R. § 488.438(f) are not a recipe book in which each element must be considered separately.  Rather, these criteria are a list of factors that CMS may consider in determining the remedy amount.  If evidence relating to just one of these factors justifies a particular remedy, then that remedy is reasonable without also considering other criteria.  As I have explained, Petitioner’s noncompliance was extremely serious because it increased a likelihood that residents of its facility would be infected with a potentially lethal virus.  That is more than enough to justify the penalty amount. 

Finally, Petitioner contends that the remedy determination must fail because CMS failed to consider Petitioner’s financial condition.  Petitioner’s brief at 25.  Petitioner argues that the burden lies on CMS to prove that Petitioner has the wherewithal to pay a penalty. 

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I disagree with Petitioner’s interpretation of the regulation.  The regulation allows a facility to come forward with evidence showing that it is not financially capable of paying a penalty amount.  That is, in effect, an affirmative defense to any remedy determination that CMS might consider making.  It does not impose on CMS the burden of ferreting out evidence concerning a facility’s financial condition – evidence that almost certainly is uniquely in the facility’s possession and not available to CMS.

Endnotes

¹  I apply the version of the regulation that was in effect in 2020.  The regulation subsequently has been amended.