Golden Living Center - LaPorte, DAB CR6461 (2024)

DECISION

I enter summary judgment sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose these civil money penalties against Petitioner, Golden Living Center – LaPorte, a Medicare-participating skilled nursing facility:  $6,810 for each day of a period that began on October 10, 2020, and that continued through October 29, 2020; and $330 for each day of a period that began on October 30, 2020, and that continued through November 26, 2020.  The penalty amounts and durations are justified by Petitioner’s failure to comply with a Medicare participation requirement.

I. Background

This case was very recently transferred to my docket from that of another administrative law judge.

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CMS moved for summary judgment, filing a brief and exhibits, identified as CMS Ex. 1 – CMS Ex. 59, in support of its motion.  Petitioner opposed the motion and filed a brief and exhibits identified as P. Ex. 1 – P. Ex. 62.

Neither party filed objections to my receiving exhibits.  However, it is unnecessary that I admit the parties’ exhibits in that I enter summary judgment based on undisputed material facts.  I cite some of the exhibits in this decision, either to illustrate undisputed facts or to address a party’s contentions and arguments.

II. Issues, Findings of Fact and Conclusions of Law

1. Issues

The issues are whether undisputed material facts establish that:  Petitioner failed to comply substantially with a Medicare participation requirement; CMS’s determination of immediate jeopardy level noncompliance is clearly erroneous; and CMS’s remedy determination is reasonable.

2. Findings of Fact and Conclusions of Law

I apply the principles of Rule 56 of the Federal Rules of Civil Procedure in deciding whether to grant summary judgment.  I base my decision on facts that are undisputed.  I make no fact finding that requires a credibility determination.  I find no impediment to deciding a case if resolving a fact dispute in favor of one party or the other would make no difference to the outcome.  Where reasonable inferences may be made from the undisputed facts, I make those inferences that are favorable to the party against whom the motion for summary judgment is filed.

I do not make fact findings based on unsupported assertions if those assertions are challenged by the opposing party.  A bald statement of fact offered by a party without support does not establish a material fact.

At bottom, the question that I ask in any case where a party moves for summary judgment is this:  is there any issue that would benefit from being resolved in an evidentiary hearing?  Fal-Meridian, Inc. v. U.S. Department of Health and Human Services, 604 F.3d 445, 449 (7th Cir. 2010).

There is no such issue in this case.  The undisputed facts unequivocally establish Petitioner’s noncompliance.  The undisputed facts establish also that the noncompliance put residents in immediate jeopardy, and that CMS’s remedy determination is reasonable.

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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 to help prevent the transmission of communicable diseases and infection.  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).

CMS’s allegations of noncompliance address a time in the autumn of 2020 when infections of the Covid-19 (“Covid”) virus ran rampant through Petitioner’s facility.  In October 2020 at least 24 of Petitioner’s residents contracted Covid.  Three of these residents, 12.5 percent of those infected, died.  CMS Ex. 34 at 20.

CMS alleges that during this period Petitioner failed to implement meaningfully a screening process that it had designed to identify individuals, including employees, attempting to enter Petitioner’s facility while infected, or potentially infected, with Covid.  CMS asserts that Petitioner’s noncompliance with its own procedures and underlying policy meant that staff members who showed signs of infection and who, in some cases, subsequently tested positive for Covid, were allowed entry to Petitioner’s facility to provide care to Petitioner’s residents.  CMS asserts that allowing these possibly infected staff members into the facility and permitting them to work potentially exposed other staff members and residents to the Covid virus.  It argues that doing so was in clear violation of accepted national standards as is embodied in guidance provided by the

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Centers for Disease Control and Prevention (CDC), state officials in Indiana, where Petitioner’s facility is located, and CMS.²

I find that the undisputed material facts unequivocally sustain CMS’s assertions.

Covid is a highly contagious, easily transmissible virus.  Frail, elderly, and sick individuals living together in a nursing facility are highly susceptible to infection by Covid and the serious consequences of infection.  CMS Ex. 43 at 1.  As the undisputed facts about Petitioner’s residents’ experience with the virus show, it is a disease that can be lethal, especially for the individuals who typically reside in nursing facilities.  For these individuals an infection with Covid can be, and all too often is, a death sentence.

Covid may be spread among infected residents living in a group setting.  But they aren’t the only source of infection.  Covid may also be transmitted by infected staff and by visitors to a facility.  The CDC and state authorities decided that facilities needed to address this possible source of infection and to protect residents against it.  The general rule expressed by federal and state agencies alike was that nursing facility staff who had been in close contact with infected individuals, who tested positive for infection, or who exhibited symptoms of Covid, should not be working.

Both the CDC and the Indiana State Department of Health (ISDH) issued guidance to skilled nursing facilities during the pandemic in 2020.  The CDC told nursing facilities that they should screen everyone, including residents, staff, and visitors entering their premises for fever of 100.0 degrees Fahrenheit and/or symptoms consistent with Covid, or for exposure to the Covid virus.  CMS Ex. 44 at 2.

The purpose of screening was to identify potentially infected individuals and to assure that they did not mingle with staff or provide care to vulnerable residents.  The CDC advised skilled nursing facilities that any staff exhibiting symptoms of Covid should be sent home.  CMS Ex. 42 at 5.  It cautioned that:

[Staff] should be reminded not to report to work when ill.  All [staff] should self-monitor when they are not at work and be actively screened upon entering the facility.

CMS Ex. 42 at 5.

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ISDH published guidance that mirrors the CDC’s guidance.  It instructed skilled nursing facilities in Indiana to actively screen staff and others entering the premises for symptoms of Covid and any history of being in close contact with someone who tests positive for Covid or shows symptoms of the illness.  CMS Ex. 49 at 2.  It explicitly directed that nursing facility staff should “not report to work with any symptoms of COVID” even if staff had tested negative for the virus.  Id. at 1.  ISDH warned facilities that it had seen multiple outbreaks of Covid when staff were allowed to work with symptoms of Covid that do not include a fever.  It explicitly warned facilities that they should not allow staff to work with runny noses and sore throats, as one example.  CMS Ex. 50 at 3.

CMS reinforced the federal and state guidance by instructing nursing facilities to screen all visitors for signs and symptoms of Covid, including fever, shortness of breath, cough (new or changed) and sore throat.  CMS Ex. 51 at 3; CMS Ex. 53 at 2, 6.  It emphasized that facilities should deny entry to those individuals having symptoms of Covid.  Id. at 6.

“Screening” involves much more than completing forms or checking one’s temperature.  CDC and ISDH policy called for facilities to actively screen their staff.  CMS Ex. 42 at 5; CMS Ex. 43 at 2, 4; CMS Ex. 49 at 2; CMS Ex. 50 at 3.  The instructions issued by these agencies could not have been clearer.  Facilities should not only record data about their staff’s signs and symptoms but should decide based on that data, and prior to admitting staff members to their premises, whether each staff member was likely or potentially infected with Covid.  Facility management should bar from facility premises any staff member who was likely or potentially infected absent special exceptions identified by CDC and ISDH for staffing emergencies.³

Petitioner adopted an infection control policy that was consistent with the instructions issued by the CDC, ISDH, and CMS.  CMS Ex. 27.  One policy goal was to ensure that staff stayed home if they had symptoms of Covid infection.  CMS Ex. 7 at 16.  Petitioner’s policy required that all staff be screened for any symptoms of Covid and any history of being in close contact with others who had been exposed to Covid or who were symptomatic.  CMS Ex. 30.  It identified symptoms of Covid, including fever or chills, cough, shortness of breath or difficulty breathing, muscle or body aches, headache, a new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.  Id. at 1.

But, although Petitioner had a screening mechanism, the undisputed facts establish that Petitioner didn’t use that mechanism to exclude potentially infected staff from working.  It complied with all of the formalities of screening except that Petitioner left it up to staff to decide whether they could work.

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Staff dutifully filled out forms in which they listed their signs and symptoms and their temperatures were recorded.  But there is nothing in the record to show that Petitioner’s management contemporaneously reviewed these forms and made on-the-spot decisions about whether staff members would be permitted to work.  Petitioner has not offered evidence of even one occasion when its management contemporaneously reviewed a staff member’s entry on the screening form and decided to bar that individual from working based on his or her reported signs or symptoms of infection.

Indeed, and as I shall describe, the evidence offered by Petitioner shows that its management left it up to staff to decide whether they were fit to work.  Many staff members decided that they could work despite manifesting signs and symptoms that are consistent with Covid infection.  Nothing in the record shows that management overruled its staff’s decisions.

The undisputed facts establish that from October 9 through October 28, 2020, 23 members of Petitioner’s staff recorded signs and symptoms of Covid but worked, nevertheless.  CMS Ex. 12; CMS Ex. 13.  I do not find it necessary to recite each instance – a few examples will suffice to illustrate the undisputed facts:⁴

• On October 9, 2020, Samantha Held, a licensed professional nurse, stated that she had a sore throat and a runny nose, had been exposed to someone infected with Covid, and had traveled within the last 14 days.  On October 13, she reported that she had a sore throat, a runny nose, cough, and diarrhea.  On October 19, she stated that she had a sore throat, a runny nose, and a cough.  CMS Ex. 12 at 3, 10, 20.  She tested positive for Covid on October 26, 2020.  CMS Ex. 38 at 5.
• On October 10, 11, and 12, 2020, Angie McKie, a certified nursing assistant reported that she had sore throat.  On October 13, she stated that she had experienced a sore throat, cough, runny nose, and exposure to a Covid-infected individual within the previous 14 days. She reported a sore throat on October 15, 2020.  On October 19, she reported that she had a runny nose and shortness of breath.  CMS Ex. 12 at 5, 6, 7, 10, 13, 18.  She tested positive for Covid on October 12, 2020, with results reported on October 15.  CMS Ex. 38 at 3.
• On October 12, 2020, Linda Vann, a certified nursing assistant, reported that she had a cough.  CMS Ex. 12 at 8.  She tested positive for Covid on that same date.  CMS Ex. 38 at 3.

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• On October 20, 2020, Jenn Sparks, an occupational therapist, stated that she had a runny nose.  On October 27 and 28 she again reported having a runny nose and noted also that she’d been exposed to an individual with Covid.  CMS Ex. 12 at 21; CMS Ex. 13 at 8-9.  She tested positive for Covid on November 2, 2020.  CMS Ex. 38 at 6.
• On October 26, 2020, Brian Gifford, a housekeeper, recited that he had been at a public event where he had been unable to wear a mask or to socially distance.  He reported that he had a cough.  On October 27, he acknowledged that he had a cough, a sore throat, and a runny nose.  On October 28, 2020, he stated that he had a cough, a sore throat, a runny nose, and nausea, vomiting, or diarrhea.  CMS Ex. 13 at 16-18.

Petitioner does not deny that numerous members of its staff reported to work after having recorded signs and symptoms that were consistent with Covid infection.  It has offered affidavits of many of these staff members.  P. Ex. 43 – P. Ex. 62.  None of the affiants contradict the data that they entered in Petitioner’s screening forms.

Importantly, none of the affiants aver that any manager at Petitioner’s facility questioned their fitness to work on the dates when they reported to work exhibiting signs and symptoms of Covid.  Indeed, the affiants make it clear that management left it up to individual staff members to decide whether they were fit to work.  For example, Linda Vann avers that on October 12, 2020, the same day that she reported to work with a cough:  “I did not feel ill or have a fever on this day, and believed that I was capable of performing my job responsibilities.”  P. Ex. 48 at 1.  Multiple other staff members asserted the same thing – that albeit symptomatic for Covid infection they concluded that they could work.  P. Ex. 43 – P. Ex. 62.  Several of these staff members aver that they concluded that their symptoms – albeit consistent with Covid infection – were, in fact, caused by something else such as a smoker’s cough or allergies.  But they decided that they could work because they concluded that their symptoms were not a consequence of Covid.  Id.

It should never have been left to staff to decide whether they could work.  Screening is meaningless if staff members can work after recording signs and symptoms that are consistent with Covid infection.

Petitioner asserts that the staff members who reported signs and symptoms consistent with Covid had tested negative for Covid infection.  Petitioner’s Response to CMS’s Motion for Summary Judgment and Pre Hearing Brief (Petitioner’s brief) at 11.  It asserts that CMS seeks to penalize Petitioner for allowing staff to work when staff merely showed signs and symptoms that “could have been related to Covid-19.”  Id.  Petitioner appears to argue that negative test results should always overrule signs and symptoms

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that are consistent with Covid, and that Petitioner was entitled to rely entirely on those results to determine who could and could not work.

Petitioner’s argument defies the ISDH’s policy.  As I have stated, in 2020, the ISDH made it clear to skilled nursing facilities that staff who were showing signs and symptoms of Covid might infect others with the virus even if they had tested negative for infection.  CMS Ex. 49 at 1-2.  That is precisely why the CDC developed and published screening criteria.  Negative test results were no substitute for active screening.

Petitioner asserts that at no time did CMS or state inspectors complain about Petitioner’s screening tool or process.  Petitioner’s brief at 18-19.  That is true.  But this case isn’t about the forms that Petitioner had its staff complete, it is about how Petitioner’s management used those forms.

Petitioner argues that, in October 2020, it faced severe staffing problems when numerous members of its staff were sick with Covid and unable to report to work.  Several of Petitioner’s management testified that during the pandemic in the autumn of 2020, Petitioner faced substantial staffing shortages.  They testified that Petitioner had sought assistance from a sister facility and had considered asking that members of the Indiana National Guard be deployed at Petitioner’s facility to assist with non-direct resident care duties.  P. Ex. 40 – P. Ex. 41.

I accept as true that Petitioner had staffing issues in October 2020.  However, I do not find that Petitioner has offered facts to show that it allowed potentially infected or infected staff to work consistent with widely accepted criteria addressing employment of such staff during the Covid pandemic.

The CDC developed criteria for determining when a Covid-infected staff member could return to work at a skilled nursing facility.  CMS Ex. 46 at 2.  Staff who had experienced mild to moderate illness and who were not immunocompromised could return to work if:  at least 10 days had passed since symptoms appeared; at least 24 hours had passed since the individual had a fever without the use of fever-reducing medication; and symptoms (such as cough or shortness of breath) had improved.  Id.  Such staff who returned to work should seek reevaluation if their symptoms worsened.  Id. at 3.

The CDC also recognized that there might be circumstances where acute staffing shortages during the pandemic would require staff to return to work even though the return to work criteria were not met.  CMS Ex. 45.  In those circumstances a facility could implement specific contingency and crisis capacity strategies:

• When staff shortages were anticipated, a facility could allow staff who had been exposed to the Covid virus but who were not known to be infected to continue to work.  However, such staff should still report an absence of symptoms or fever

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before beginning to work.  Such staff who developed “even mild symptoms consistent with Covid-19 must cease patient care activities” and leave work.  Id. at 2.

• When staff shortages occurred despite other mitigation strategies, a facility could allow staff with suspected or confirmed Covid to return to work.  Such staff should be restricted from contact with severely immunocompromised residents.  The facility should prioritize such staff’s duties by:  first, allowing them to perform job duties with no resident interaction; then, to provide direct care only to residents with confirmed or suspected Covid infections; and, only as a last resort, to provide direct care for residents without suspected or confirmed Covid infections.  CMS Ex. 45 at 3.

ISDH also allowed facility staff who were Covid-positive to provide care to residents where severe staffing shortages existed.  However, ISDH told facilities in Indiana that only asymptomatic staff should provide care in areas of the facilities where Covid-positive residents were housed.  CMS Ex. 50 at 3.

Petitioner offered no evidence to show that it had adopted either the CDC or ISDH criteria for allowing Covid-infected or exposed staff to work.  It offered no policy statements, no memoranda of management decisions, and no testimony that such criteria had been considered or adopted.  See P. Ex. 39 – P. Ex. 42.  Petitioner’s acting director of nursing testified that the facility had acted pursuant to the CDC and ISDH criteria.  P. Ex. 42 at 4-5.  However, that statement is a bald conclusion absent a showing by Petitioner that it actually implemented the CDC and ISDH criteria.  Petitioner offered no evidence to show that it devised any criteria for determining under what circumstances such employees could work.  See P Ex. 39 – P. Ex. 42.  Indeed, none of Petitioner’s management testified they had assigned such staff to work consistent with their symptoms or test results.  See id.  In the absence of such evidence, I conclude that it is undisputed that Petitioner never adopted criteria establishing when Covid-positive, exposed, or symptomatic employees could work, and under what circumstances.

Petitioner relies on the testimony of Mark Lee Stillwell, M.D., F.A.C.P. to support its contention that it relied on the CDC’s and ISDH’s guidance for allowing infected or potentially infected staff to work.  P. Ex. 37 at 6.  I find that Dr. Stillwell’s testimony is not an impediment to my issuing summary judgment because it does not raise a disputed issue of material fact.

Dr. Stillwell is not a fact witness.  He does not work at Petitioner’s facility, and he did not witness any of the events that are the basis for my decision.  He opines that Petitioner:  “was obviously relying on the CDC guidance when it allowed employees with mild symptoms (most unrelated to Covid-19) to continue working in the facility.”  P. Ex. 37 at 6.  But Dr. Stillwell does not identify any facts that support his conclusion except for

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facts showing that Petitioner had staffing problems and that it allowed staff members who reported signs and symptoms of Covid to work.  As I have explained, allowing possibly infected staff to work may be justified under the CDC’s criteria, but only in narrowly defined circumstances.  Dr. Stillwell points to nothing to show that Petitioner’s management employed the CDC criteria to decide who could work and under what circumstances.

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 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.  To the contrary, the undisputed facts lead inexorably to the conclusion that Petitioner’s noncompliance put residents at immediate jeopardy.

As I have discussed, Covid is a virus that has lethal consequences for the elderly and infirm.  Failure to protect residents of a skilled nursing facility from exposure to Covid clearly puts these residents at risk of serious injury, harm, impairment, or death.  The contagiousness of Covid, its ease of transmission, creates the likelihood that if residents are exposed to the virus some will become ill and some of them will die.

Petitioner argues that there was no immediate jeopardy level noncompliance because the undisputed facts do not establish it to have violated the infection control regulation.  I have addressed Petitioner’s arguments on issue of noncompliance, and I find them to be without merit.

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3. Remedy

The remedy that CMS determined to impose against Petitioner consists of civil money penalties of:  $6,810 for each day of a period that began on October 10, 2020, and that continued through October 29, 2020; and $330 for each day of a period that began on October 30, 2020, and that continued through November 26, 2020.  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. § 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 modest, falling at the bottoms of the ranges for immediate jeopardy and non-immediate jeopardy level penalties.

CMS asserts that the penalty amounts are justified based on the seriousness of Petitioner’s noncompliance, its culpability, and its compliance history.  Undisputed facts amply support CMS’s assertions.

Petitioner’s noncompliance was extremely serious.  Infection with Covid often is a death sentence for the elderly and infirm individuals who reside in skilled nursing facilities.  Petitioner’s failure to actively screen its staff exposed residents to potentially infected individuals, creating a likelihood that residents would be infected with a lethal illness.

I find that undisputed facts establish Petitioner to have been culpable.  The failure to closely review the screening forms and to exclude possibly infected individuals from Petitioner’s premises, and the failure to follow CDC and ISDH criteria for deciding when an infected or potentially infected staff member might work is an evident failure by Petitioner’s management to exercise control over staff during the pandemic.

Moreover, Petitioner has a history of noncompliance with the infection control regulation.  CMS found Petitioner to be out of compliance with this regulation in 2018

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and in 2019.  CMS Ex. 6 at 2, 4.  This previous noncompliance did not relate to the Covid pandemic.  Nevertheless, it establishes that Petitioner was not conscientiously addressing the need for infection prevention and control.

Petitioner challenges the amount and duration of the penalties.  Petitioner’s brief at 25.  It offers no facts to dispute the remedy determination aside from incorporating its arguments about compliance.  There is no need for me to reiterate my analysis of that issue here.

Endnotes

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

²  CMS alleges additionally that Petitioner’s staff failed to properly wear or use personal protective equipment.  I make no findings addressing this issue because the findings that I make about Petitioner’s failure to implement a screening process are sufficient to sustain my conclusions that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.80, that its noncompliance was at the immediate jeopardy level, and that CMS’s remedy determination is reasonable.

³  I discuss these exceptions below.

⁴  CMS has provided a complete list of the staff members and the signs and symptoms that they recorded, with citations to exhibits.  CMS’s Motion for Summary Judgment and Prehearing Brief (CMS’s brief) at 9-11.  Petitioner has not disputed these facts except to assert that in one instance, CMS may have misstated the name of the employee.