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                              Yoakum Nursing and Rehabilitation Center, CR6306 (2023)
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Yoakum Nursing and Rehabilitation Center, CR6306 (2023)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Yoakum Nursing and Rehabilitation Center
(CCN: 675736),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-21-694Decision No. CR6306June 23, 2023

        
              
    

      DECISION

During the coronavirus disease of 2019 (COVID or COVID-19) pandemic, Yoakum Nursing and Rehabilitation Center (Petitioner or facility) kept a cognitively impaired COVID-negative resident in the facility’s secure memory unit even though the residents in that unit were COVID-positive.  Petitioner did not require staff to change or disinfect their personal protective equipment (PPE), other than gloves, in between caring for COVID-positive and COVID-negative residents in the secure memory unit.  Separately, Petitioner also did not determine whether advance directives for residents were valid before documenting the directives in the residents’ clinical record.  As a result, the Centers for Medicare & Medicaid Services (CMS) found Petitioner to be noncompliant with Medicare program participation requirements.  CMS also determined that Petitioner’s COVID practices in the secure memory unit immediately jeopardized the health and safety of residents.  CMS imposed per-day civil money penalties (CMP) for the alleged noncompliance.

In response, Petitioner sought review of CMS’s determination arguing that its COVID practices were consistent with guidance from the Centers for Disease Control and

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Prevention (CDC).  It also argued that it had no responsibility to determine whether residents properly executed their advance directives.

As explained below, I agree with Petitioner’s position in part.  Petitioner’s decision to keep a cognitively impaired resident in the secure memory unit with other COVID-positive residents was consistent with CDC guidance; however, staff’s failure to change PPE between caring for COVID-positive and COVID-negative residents in that unit was not.  The failure to change PPE supports the facility’s noncompliance with the Medicare requirement related to infection control, but this deficient conduct, alone, was not likely to cause serious harm to residents.  Therefore, CMS’s immediate jeopardy determination was clearly erroneous.  Finally, despite Petitioner’s argument that the advance directive requirement cited by CMS does not require a facility to advise a resident whether an advance directive is valid, I conclude that Petitioner was noncompliant because the facility needed to determine whether the advance directives were valid before documenting them in resident charts for staff to implement.

Based on the immediate jeopardy finding, CMS imposed a $9,500 per-day CMP for four days, from December 1, 2020, through December 4, 2020.  Based on continuing noncompliance that did not immediately jeopardize residents, CMS imposed a $350 per-day CMP for 26 days from December 5, 2020, through December 30, 2020.  Because I do not uphold CMS’s determination as to the existence of immediate jeopardy, but uphold CMS’s determinations as to noncompliance, I conclude that a $350 per-day CMP amount for the entire period of noncompliance, i.e., from December 1, 2020, through December 30, 2020, is appropriate under the relevant statutory and regulatory factors.  The total CMP amount is modified to $10,500.

I.  Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at a skilled nursing facility (SNF).  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).

In addition to complying with the terms of the Medicare provider agreement, a participating SNF must meet a variety of ongoing statutory requirements regarding how it

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provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  SNFs also must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”1 42 U.S.C. § 1395i-3(d)(4)(B); *see* 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary promulgated regulations to establish those additional requirements.  *See* 42 C.F.R. pt. 483, subpt. B.2

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.” 42 C.F.R. § 488.301; *see* 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301.  To maintain “substantial compliance,” an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301.

Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels.  One level comprises deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C. § 1395i-3(h)(1).  “Immediate jeopardy” exists when “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.

The Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs.  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).  When the results of a survey show that an SNF is not in substantial compliance with Medicare program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and

Page 4

severity (i.e., the degree of harm or potential harm) for each deficiency.3*See* 42 C.F.R. § 488.404(a)-(b).

One enforcement remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‐instance CMP for each instance of the SNF’s noncompliance or a per‐day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‐3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,233 to $22,320 for per-instance CMPs; $112 to $6,695 per day for less serious noncompliance; or $6,808 to $22,320 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); *see also* 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF).  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‐3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); *see also* 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if CMS makes such a showing, the SNF must then prove substantial compliance by a preponderance of the evidence.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997); *see* *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d*, *Batavia Nursing & Convalescent Ctr. v. Thompson*,129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001).  If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

Page 5

If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP.  The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); *see*42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I);42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.42 C.F.R. § 488.438(e)(1).

Either the SNF or CMS may seek administrative review of an ALJ’s decision.  42 C.F.R. § 498.80.

II.  Background and Procedural History

Petitioner is an SNF that participates in the Medicare program.  Petitioner is located in Yoakum, Texas.  From December 1, 2020 through December 5, 2020, the Texas Department of Aging and Disability Services (state agency) conducted a COVID-19 Focused Infection Control Survey of the facility and documented the following deficiencies in a Statement of Deficiencies (SOD):

42 C.F.R. § 483.10(c)(6), (8), (g)(12)(i)-(v) (F-Tag 578) (scope and severity (S/S) =E) (Request/Refuse/Discontinue Treatment; Formulate Advance Directive); and
	42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (F-Tag 880) (S/S = J) (Infection Prevention and Control).CMS Ex. 1 at 2, 6; CMS Ex. 2 at 1; CMS Ex. 3 ¶¶ 3-4.  The SOD stated that the infection prevention and control deficiency immediately jeopardized resident health and safety.  CMS Ex. 1 at 6.  The SOD further stated that the immediate jeopardy conditions were removed on December 5, 2020, but that the facility remained out of substantial compliance with program requirements at a level that posed no actual harm, but with the potential for more than minimal harm that is not immediate jeopardy.  CMS Ex. 1 at 9.  Petitioner eventually achieved substantial compliance with Medicare requirements for SNFs on December 31, 2020.  CMS Ex. 2 at 1.

On December 17, 2020, the state agency informed Petitioner of the SOD and imposed, among other remedies, a directed plan of correction.  CMS Ex. 2 at 1, 3.  Petitioner filed a request for hearing to dispute the state agency action.  Subsequently, in a notice of initial determination dated March 1, 2021, CMS imposed the following remedies based on the findings in the SOD:

$9,500 per-day civil money penalty (CMP) for four days, from December 1, 2020, through December 4, 2020; and
	$350 per-day CMP for 26 days from December 5, 2020, through December 30, 2020.Page 6

CMS Ex. 2 at 2.

Petitioner requested a hearing on April 23, 2021, to dispute CMS’s actions.  The cases were assigned to me and I consolidated them under Docket No. C-21-694.

Consistent with my Standing Prehearing Order (SPO), CMS filed a prehearing brief and 34 proposed exhibits.  Two of the exhibits were written direct testimony from witnesses (CMS Exs. 3, 4).  Petitioner submitted a prehearing brief and five proposed exhibits.  Two of the exhibits were written direct testimony from witnesses (P. Exs. 1, 5).  Petitioner also filed objections to some of CMS’s exhibits and requested to cross-examine both CMS witnesses.  CMS did not object to any of Petitioner’s proposed exhibits or request to cross-examine either of Petitioner’s witnesses.

As explained in my July 12, 2022 Notice of Hearing, I admitted Petitioner Exhibits 1 through 5 and CMS Exhibits 1 through 3 and 5 through 34 into the record.  I overruled all of Petitioner’s objections to CMS’s proposed exhibits except as to CMS Exhibit 4 (the written direct testimony for a witness), which I excluded from the record.

On August 22, 2022, I held a hearing for the cross-examination of CMS’s remaining witness.4 During the hearing, I observed that both parties had cited documents on the internet in their prehearing briefs.  I gave both parties an opportunity (1) to file, post-hearing, a printed version of those internet sources that could be marked as exhibits, and (2) to raise evidentiary objections to such new exhibits.  Hearing Transcript (Tr.) 38, 61.

After the hearing, Petitioner submitted Petitioner Exhibits 6 through 9 while CMS submitted CMS Exhibit 35.  Petitioner objected to CMS Exhibit 35.  CMS did not object to Petitioner Exhibits 6 through 9.

Both parties timely filed closing briefs (CMS Br. and P. Br.).5

On June 6, 2023, I issued an order (June 6 Order) indicating that the record in this case required additional evidence as to how COVID-19 spreads among people.  I stated my intent to admit an October 28, 2020 CDC public statement entitled “How COVID-19 Spreads” as ALJ Exhibit 1.  I provided 42 C.F.R. § 498.60(b)(2) as authority for my

Page 7

proposed course of action.  I provided the parties with an opportunity to file objections to ALJ Exhibit 1 and/or additional exhibits that discuss how COVID-19 spreads.

Petitioner filed an objection to ALJ Exhibit 1, five additional proposed exhibits (P. Exs. 10, 11, 11a, 12, and 13), and an amended exhibit list.  CMS did not file a response to the June 6 Order.

III.  Evidentiary Rulings

In the Notice of Hearing, I ruled on all objections to the exhibits submitted by the parties before the hearing.  However, I must rule on the admission of proposed exhibits submitted following the hearing.

Petitioner submitted four additional proposed exhibits.  CMS did not object to them.  Therefore, I admit Petitioner Exhibits 6 through 9 into the record.

CMS filed one proposed exhibit.  That exhibit is an article from the American Cancer Society.  CMS Ex. 35.  Petitioner objected to it because the article was last updated in April 2022 and may not reflect the same guidance that was in effect at the time of the December 2020 survey.  CMS conceded this point.  CMS Br. at 15-16 n.4.  I also observe that CMS did not file the exhibit within one week of the hearing as I had instructed (Tr. 61), making the filing untimely without good cause.  Therefore, I sustain Petitioner’s objection to CMS Exhibit 35 and exclude the exhibit.

Petitioner objected to ALJ Exhibit 1, stating that CDC guidance does not constitute rules and that the information in ALJ Exhibit 1 may be outdated.  I overrule Petitioner’s objection.  My purpose in proposing to admit ALJ Exhibit 1 is to add evidence to the record as to the ways that COVID-19 is transmitted among people.  Petitioner failed to provide any basis for stating that the information in ALJ Exhibit 1 is outdated.  In fact, Petitioner submitted proposed Petitioner Exhibit 12, which is information from the World Health Organization (WHO) website on COVID-19 transmission that is consistent with the information in ALJ Exhibit 1.  Therefore, I admit ALJ Exhibit 1 into the record.

Petitioner proposed five new exhibits in response to my June 6 Order.  When determining whether to admit or exclude evidence, I am to receive relevant and material evidence into the record, and I am not required to exclude evidence simply because it is inadmissible under the rules of evidence used by the courts.  42 C.F.R. §§ 498.60(b), 498.61; *see also* 5 U.S.C. § 556(d).  I discuss each newly proposed exhibit below.

Proposed Petitioner Exhibit 10 is an Association of American Medical Colleges’ article about ongoing research as to whether some individuals are immune to COVID-19.  The article does not provide any definitive results on the issue.  Therefore, this proposed exhibit is not sufficiently relevant, and I exclude it.

Page 8

Proposed Petitioner Exhibit 11 is an article entitled “Carbohydrate vitrification in aerosolized saliva is associated with the humidity-dependent infectious potential of airborne coronavirus.” Portions of this article highlighted by Petitioner indicate that the authors recommend that an indoor humidity of 60% to 40% be maintained because “[r]esults suggest that maintaining increased [relative humidity] indoors may affect the persistence of airborne coronavirus.” Proposed Petitioner Exhibit 11a purports to show the average monthly humidity of the location of Petitioner’s facility.  While these documents appear to relate to environmental conditions and the transmission of COVID-19, the specific subject matter does not appear to be implicated in this case.  If these documents relate to a new theory by Petitioner as to why it is in substantial compliance, it is unclear precisely how this supports Petitioner’s case.  Therefore, these exhibits are not sufficiently relevant, and I exclude them.

Petitioner Exhibit 12 is from WHO’s website.  This exhibit includes the answer to the question:  “Coronavirus disease (COVID-19):  How is it transmitted?” The WHO’s answer includes specific information as to how COVID-19 is transmitted.  I admit this exhibit into the record because it is relevant and responsive to my June 6 Order.

Petitioner Exhibit 13 is a WHO document entitled “What To Do If Someone is Sick in Your Household.” While one can glean the ways COVID-19 is transmitted by reviewing the methods of preventing transmission, this document does not primarily discuss the methods of transmission.  Further, this document is focused on caring for a COVID-positive individual at home.  Therefore, I exclude this exhibit as insufficiently relevant and not directly responsive to the criteria stated in my June 6 Order.

IV.  Issues

Whether Petitioner was in substantial compliance with Medicare program requirements for SNFs at 42 C.F.R. §§ 483.10(c)(6), (8), (g)(12)(i)-(v) and/or 483.80(a)(1), (2), (4), (e), (f).
	If Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f), whether CMS’s determination that this deficiency immediately jeopardized the health and safety of Petitioner’s residents is clearly erroneous.  42 C.F.R. §§ 498.3(b)(14)(i), 498.60(c)(2).
	If Petitioner was not in substantial compliance with Medicare program requirements, whether a $9,500 per-day CMP for four days and a $350 per-day CMP for 26 days is appropriate under the statutory and regulatory factors for setting a penalty amount.  42 U.S.C. § 1320a-7a(d); 42 C.F.R. § 488.438(f).Page 9

V.  Findings of Fact, Conclusions of Law, and Analysis

**Infectious Disease Control and Prevention Deficiency**

Although CMS found Petitioner to have been noncompliant with 42 C.F.R. § 483.80(a)(1)-(2), it did so based on factual allegations in the SOD that can be broadly divided into two groups:  1) Petitioner’s failure to move Resident 1 (R1), a COVID-negative resident, out of the secure memory care unit after the other residents in that unit tested positive for COVID-19; and 2) Petitioner’s staff’s failure to change PPE after assisting a COVID-positive resident but before assisting R1.  CMS Ex. 1 at 8-9.  While all of the factual allegations are related to Petitioner’s implementation of infection control and prevention practices, I first discuss the facts and law concerning Petitioner’s decision to keep R1 in the memory care unit and then separately discuss the facts and law concerning staff PPE use.

*****In the fall of 2020, Petitioner kept R1 in the secure memory unit with other residents who were COVID-positive even though R1 was COVID-negative.  Petitioner did this to avoid R1, a cognitively impaired resident, from potentially infecting residents in the facility due to his likely inability to comply with rules to wear a mask and ability to ambulate around the facility once he was no longer in the secure memory unit.*****On October 27, 2020, a facility staff member who worked exclusively in the facility’s secure memory unit tested positive for COVID-19 and likely exposed all the residents in that unit.  P. Ex. 1 at 1; P. Ex. 5 at 1.  About two weeks later, on November 11, the first two residents in the secure unit tested positive for COVID-19.  P. Ex. 1 at 1; P. Ex. 5 at 1.  Those two were transferred to a sister facility with a dedicated COVID-19 “hot zone” and their roommates were moved to a designated “warm zone” unit within the facility for isolation and monitoring for two weeks.  P. Ex. 1 at 1; P. Ex. 5 at 1; CMS Ex. 1 at 2 (describing “Warm Zone”).  On November 13, five more residents in the unit tested positive.  P. Ex. 1 at 2; P. Ex. 5 at 2.  Those five were similarly transferred to the sister facility and their roommates also sent to the “warm zone.” P. Ex. 1 at 2; P. Ex. 5 at 2.  On November 16, six more residents from the secure unit tested positive.  P. Ex. 1 at 2; P. Ex. 5 at 2.  By then, however, the sister facility had expressed difficulty caring for the transferred COVID-positive residents because of their refusal to stay isolated in rooms.  P. Ex. 1 at 2; P. Ex. 5 at 2.

Shortly thereafter, on November 19, another six residents tested positive, bringing the total to 19 residents from the secure area as positive for COVID-19.  P. Ex. 1 at 2; P. Ex. 5 at 2.  The facility then held an ad-hoc Quality Assurance and Performance Improvement (QAPI) meeting on that date, and the QAPI committee, which included the facility’s Administrator, Director of Nursing, and Medical Director, decided to keep the COVID-positive residents in the secure unit “due to wandering and other behaviors.”
P. Ex. 2 at 1.  Because the other residents’ exposure to COVID-19 “was already so great” in that unit, the committee designated the entire secure memory unit as its “[h]ot zone” for isolation and care of affected residents.  P. Ex. 2 at 1; P. Ex. 5 at 2.  The committee also stated and reiterated in part that all residents in that unit would stay in the unit “due to wandering and other behaviors.”

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P. Ex. 2 at 1.  According to the Administrator’s testimony, in making their determinations, the committee also discussed “the challenges of the sister facility managing the residents’ behaviors.” P. Ex. 5 at 2.

Four residents, including R1, who were still COVID-negative would remain housed with COVID-positive residents in the facility’s designated “hot zone.” P. Ex. 2 at 1.  R1 had diagnoses of tongue cancer, Alzheimer’s disease, vascular dementia, and had a Brief Interview for Mental Status (BIMS) score of 12, which means “moderately impaired.” CMS Ex. 12 at 1, 9; CMS Ex. 1 at 10.  Unrebutted witness testimony supports that R1 was an elopement risk, noncompliant with directives, refused to wear a mask, and was known for his frequent wandering.6 P. Ex. 1 at 1; P. Ex. 5 at 1; *see also* Tr. 16 (surveyor also agreeing on cross-examination that R1 was in the secure unit because he had moderate cognitive impairment and was diagnosed with vascular dementia and Alzheimer’s disease); CMS Ex. 12 at 18 (supporting how R1 did not need mobility devices).  Eventually, three of the four remaining COVID-negative residents would test positive, leaving R1 as the only remaining COVID-negative residnet.  CMS Ex. 10 at 6; P. Ex. 1 at 2; P. Ex. 5 at 2.

*****The facility’s decision to keep R1 in the secure memory unit with other residents who were COVID-positive did not amount to a violation of the infection control regulations at 42 C.F.R. §*** ***483.80(a)(1)-(2) (F-Tag 880) because CDC guidance permitted facilities to keep residents with cognitive impairment, like R1, in such a unit even though other residents in the unit were COVID-positive.*****The Social Security Act (Act) states that an SNF must:

Establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection.

42 U.S.C. § 1395i-3(d)(3)(A).  Consistent with the Act, the Secretary’s implementing regulations require facilities to establish and maintain an infection control program that includes, among other things, a “system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents,

Page 11

staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards.” 42 C.F.R. § 483.80(a)(1).  As explained in prior case decisions, in light of the regulation’s injunction to “establish *and maintain*” (italics added) an infection control program and stated focus on achieving health outcomes (*e.g.*, the prevention of the transmission of disease and infection), section 483.65 requires an SNF to do more than merely adopt such a program as its internal policy; the regulation also requires the SNF to implement the program’s prescribed precautions.7*Golden Living Ctr. - Superior*, DAB No. 2768 at 7 (2017) (citing *Heritage House of Marshall Health & Rehab. Ctr.*, DAB No. 2566 at 12 (2014)).

CMS takes issue with the facility’s decision to keep R1 in the secure unit rather than transfer him to a “warm zone” unit, arguing that the decision “put [R1] in serious jeopardy of being infected with COVID-19, as [R1] was in close proximity to COVID-infected individuals.” CMS Br. at 12.  CMS argues that CDC guidance issued at the time of the survey recommended that nursing homes create a designated COVID-19 care unit for residents with confirmed COVID-19.  CMS Ex. 6 at 1-2; CMS Br. at 5.  CMS adds that the CDC further recommended isolating and cohorting patients with COVID-19.  CMS Ex. 5 at 1-2, 9.

I acknowledge CMS’s concern for R1 and his increased risk of contracting COVID-19 while staying in the secure memory unit, which was designated as the facility’s COVID-19 care unit.  Nevertheless, as explained below, I find CMS’s argument, that Petitioner failed to comply with CDC guidance, unpersuasive.

Initially, the facility’s written procedures state that the facility complies with CDC and local and state guidelines “regarding awareness and prevention of the spread of Coronavirus 2019.” CMS Ex. 3 ⁋ 85; P. Ex. 1 at 3; P. Ex. 5 at 3 (“The [f]acility staff were instructed to follow the guidance set forth by the CDC.”).  Although facilities were advised to isolate a resident who is positive with COVID-19 from other residents, the CDC also recognized that infection prevention strategies to prevent the spread of COVID-19 were “especially challenging” to implement in dedicated memory care units where numerous residents with cognitive impairment reside together.  P. Ex. 6 at 1.  In its “Considerations for Memory Care Units in Long-Term Care Facilities,” the CDC specifically acknowledged that “[m]oving residents with cognitive impairment to new

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locations within the facility may cause disorientation, anger, and agitation, as well as increase risks for other safety concerns such as falls or wandering.” P. Ex. 6 at 1.  Given these factors, the CDC expressly permitted facilities the flexibility to “[c]onsider potential risks and benefits” of moving residents out of the memory care unit to a designated COVID-19 care unit, and to “determine that it is safer to maintain care of residents with COVID-19 on the memory unit with dedicated personnel.” P. Ex. 6 at 1.

During the survey, the Administrator reported that the facility specifically considered the CDC’s Memory Care Unit guidance in its determination to keep its cognitively impaired residents, whether COVID-positive or COVID-negative, in the secure memory unit.  CMS Ex. 10 at 1.  The facility’s QAPI Meeting Minutes further show that, consistent with the CDC’s guidance, the facility had evaluated the trade-offs of keeping cognitively impaired residents who were COVID-negative, like R1, in the secure unit.  As noted, the QAPI committee concluded that their “wandering and other behaviors” justified their remaining in the secure unit.  P. Ex. 2 at 1; *see also* P. Ex. 1 at 2; P. Ex. 5 at 2; Tr. 17 (surveyor agreeing on cross-examination that the COVID-positive residents had diagnoses that warranted keeping them in a memory unit).  According to the Administrator, the QAPI committee also considered the “challenges” its sister facility faced after accepting the first COVID-positive patients, including “managing residents’ behaviors,” which further informed Petitioner’s determination that a cognitively impaired resident, like R1, would have been unsafe and may well have spread COVID outside the secure unit due to his exposure and potential for walking through the facility without a mask.  P. Ex. 5 at 2; P. Ex. 1 at 2; P. Ex. 2 at 1 (noting the “possibility of their [COVID-negative residents] exposure was already so great”); P. Ex. 8 at 2 (state health guidance stating that “[i]t may be difficult or impossible to get a resident with dementia to wear a face mask”); P. Ex. 7 at 15 (“[T]he subpopulation of residents with dementia and Alzheimer’s disease are often unable to express when they experience symptoms and could unknowingly (and without staff knowing) spread the virus if infected.”).

CMS did not address whether the facility’s decision to keep R1 in the secure unit still amounts to a violation of the infection control regulation in light of the CDC guidance that permitted facilities to make that determination.  Instead, CMS argued that Petitioner’s justifications to keep R1 in the secure unit were post-hoc.  CMS Br. at 11-12 (arguing that Petitioner “made an ad-hoc decision and now, post-survey, provides its [post-]hoc justification for housing [R1] amongst COVID-positive residents when it only presumed [R1] positive.”). However, as mentioned above, the facility Administrator emailed the surveyor *on the first day of the survey*, December 1, 2020, specifically citing the CDC guidance and explaining “[t]his is the basic guidance leading us to the decision to maintain our residents on secured unit in our facility.” CMS Ex. 10 at 1-3.  Further, as discussed above, Petitioner provided the November 19, 2020 QAPI Meeting Minutes where the decision was made along with the basis for the decision.  P. Ex. 2  at 1.  Petitioner’s witnesses testified about this decision in their written direct testimony as well.  P. Ex. 1 at 2; P. Ex. 5 at 2.

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In addition, CMS’s argument ignores the testimony of the surveyor on cross-examination.  The surveyor testified that secure memory units are usually intended for residents with dementia and cognitively impairments who are prone to wandering and elopement.  Tr. 15-16.  The surveyor agreed that it can be dangerous for residents housed in the secure unit to be housed outside the unit.  Tr. 16.  The surveyor agreed that R1 was in the secure unit because he was diagnosed with vascular dementia and Alzheimer’s disease and was moderately cognitively impaired.  Tr. 16.  The surveyor also agreed that Residents 2 through 18 had diagnoses that indicated they needed to be in a memory care unit.  Tr. 17.  The surveyor testified that residents with cognitive impairments tend not to be compliant concerning restrictions on movement in a facility unless they are in the secure unit.  Tr. 18.  The surveyor agreed that Petitioner’s decision to keep R1 in the secure unit was not contrary to CDC guidance.  Tr. 25, 51-53.

Based on the evidence that the facility documented its reasons for keeping COVID-negative residents, including R1, in the secure memory unit and that those reasons were consistent with CDC guidance, I conclude that the facility’s decision to keep R1 in the secure memory unit did not violate Medicare infection prevention and control requirements.

*****On December 2, 2020, the surveyor observed that staff provide care to COVID-positive residents and then provide care to R1, a COVID-negative resident, without changing PPE (other than gloves).*****On December 2, 2020, the surveyor observed a certified nurse aide attend to a COVID-positive resident (R13) in the resident’s room at about 12:47 p.m. and then enter R1’s room almost half an hour later at 1:15 p.m., without changing or decontaminating PPE besides using hand sanitizer and changing out gloves in between.  CMS Ex. 1 at 19; CMS Ex. 3 at ⁋⁋ 66, 68 (referring to “CNA E”).

Later that day, the surveyor observed a licensed nurse failing to change PPE between caring for COVID-positive residents at 1:42 p.m. (R8 and R9) and then R1 at 1:53 p.m.  CMS Ex. 1 at 21; CMS Ex. 3 ⁋⁋ 79-80 (referring to “LVN F”).

Finally, the surveyor observed the same nurse aide enter another COVID-positive resident’s (R16’s) room at 4:57 p.m. and then enter R1’s room at 5:00 p.m., again without changing PPE besides using hand sanitizer and changing out gloves.  CMS Ex. 1 at 20; CMS Ex. 3 at ⁋⁋ 74-75.

*****Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. §*** ***483.80(a)(1)-(2) (F-Tag 880) based on staff’s failure to change or disinfect PPE between treating COVID-positive residents and R1.*****Page 14

Aside from the facility’s decision to keep R1 in the secure unit with other residents who were COVID-positive, which was discussed above, CMS alleged that the facility’s failure to have staff change PPE between caring for those COVID-positive residents and R1 supports a separate basis for noncompliance.  Primarily, CMS asserted that the surveyor observed multiple instances of staff failing to change PPE between caring for COVID-positive residents and R1, a COVID-negative resident.  CMS Br. at 13-14.

Petitioner asserts that the observed facts do not constitute noncompliance because the surveyor did not observe staff “for the entire interval between caring for a positive resident and then [R1] and therefore cannot be sure that the staff did not, in fact, change PPE.”  P. Br. at 25 (citing Tr. 33-34); *see also* P. Br. at 21 (arguing surveyor was “unable to testify that she observed facts constituting non-compliance with regard to don/doffing of PPE.”).  Petitioner adds that, on cross examination, the surveyor “admitted that she does not, in fact, know what [the nurse aide] was doing for the entire time between 12:23 p.m. and 1:15 p.m.,” when she cared for COVID-positive residents and then R1, and acknowledged that “it is possible” the nurse aide did in fact don and doff PPE during that time frame.  P. Br. at 15-16 (citing Tr. 33-34).

Petitioner overstates the significance of the surveyor’s testimony on cross-examination, where she simply acknowledged the possibility that the nurse aide *could have* changed PPE out of the surveyor’s sight.  *See* Tr. 33-34 (stating “I guess” in response to a question as to whether the nurse aide could have changed her PPE between 12:23 p.m. and 1:15 p.m.).  But the acknowledgment that the nurse aide could have changed her PPE in the almost hour-long period between 12:23 p.m. and 1:15 p.m. is irrelevant because the surveyor also observed the nurse aide caring for another COVID-positive resident (R13) at 12:47 p.m., which was within a half hour of the aide’s entering R1’s room 1:15 p.m.  CMS Ex. 3 at ⁋ 66.  The surveyor’s unrebutted observations that were closer in time support that a change of PPE was unlikely.

Petitioner’s broader argument, that the surveyor did not monitor the nurse aide continuously, is also unavailing.  The evidentiary standard in this case is preponderance of the evidence.  *Batavia Nursing*, DAB No. 1911; *Batavia Nursing*, DAB No. 1904; *Emerald Oaks*, DAB No. 1800.  As part of its prima facie case, CMS relies, in part, on the surveyor’s observations above, which support that the nurse aide likely did not change her PPE (besides changing gloves and performing hand hygiene) between caring for COVID-positive residents and R1.  Given CMS’s evidence, Petitioner had the burden to show by a preponderance of the evidence that the nurse aide did, in fact, change her PPE.  *Batavia Nursing*, DAB No. 1911; *Batavia Nursing*, DAB No. 1904; *Emerald Oaks*, DAB No. 1800.  Petitioner did not do so.8 The surveyor’s mere recognition that a change

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in PPE was possible does not outweigh the surveyor’s mid-day observations of the nurse aide.

Additional prima facie evidence further confirms that staff did not change PPE in between caring for COVID-positive residents and R1.  In addition to the mid-day observations above, the surveyor also observed the same aide enter a COVID-positive resident’s room at 4:57 p.m. and then R1’s room *three minutes later* without changing PPE.  CMS Ex. 3 at ⁋⁋ 74-75.  Petitioner did not address these observations.  Nor did Petitioner address the surveyor’s observation that a licensed nurse failed to change PPE between caring for COVID-positive residents at 1:42 p.m. (R8 and R9) and then R1 *11 minutes later*.  CMS Ex. 3 ⁋⁋ 79-80.  Finally, CMS also relies on multiple staff reporting in interviews that they were trained to change PPE when entering and exiting the COVID-19 unit only.  CMS Ex. 3 at ⁋⁋ 71, 81 (interviews with the nurse aide and licensed nurse).  These staff responses during interviews are consistent with the testimony of Petitioner’s Administrator and DON.  P. Ex. 1 at 3; P. Ex. 5 at 3.  The weight of the evidence on this issue, including the unrebutted observations above, supports that staff did not change PPE in between caring for COVID-positive residents and R1, and, in fact, did not change PPE while they were providing care within the secure memory unit.

CMS argues that staff’s failure to change PPE before caring for R1 ran afoul of CDC guidance that “any reusable PPE must be properly cleaned, decontaminated, and maintained after and between uses.” CMS Br. at 14 (citing CMS Ex. 7 at 1-2).  CMS adds that proper doffing PPE following contact with a COVID-positive resident prevents contamination and that keeping the same gowns between residents could have led to R1’s contracting COVID-19.  CMS Br. at 14; CMS Ex. 5 at 8; *see also* CMS Ex. 6 at 6 (infection control pathway for surveyors indicating PPE should be removed appropriately and discarded “after resident care, prior to leaving room.”).  CMS maintains that, by failing to follow CDC guidance regarding donning and doffing, Petitioner increased R1’s risk of contracting COVID-19 via potentially infectious particles lingering on staff’s PPE.  CMS Br. at 14; CMS Ex. 5 at 2 (CDC guidance recognizing that person-to-person transmission from contact with contaminated surfaces, like contaminated PPE, “might occur.”).

I agree with CMS that staff’s failure to change or decontaminate PPE before treating R1 in the secure unit increased R1’s risk of contracting COVID-19 and therefore had the potential for more than minimal harm.  Both the WHO and CDC indicate that individuals may contract COVID-19 by touching contaminated surfaces and then touching their eyes, noses, or mouths.  P. Ex. 12 at 1; ALJ Ex. 1 at 2.  The WHO also listed the following as a precaution to lower the risk of contracting COVID-19: “Avoid touching surfaces, especially in pubic settings or health facilities, in case people infected with COVID-19 have touched them.” P. Ex. 12 at 6.  Therefore, Petitioner was out of substantial compliance with the infection control requirements.

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In response, Petitioner cites state health guidance for an “isolation wing/unit” and argues that, because the entire secure memory unit had been designated as a “hot zone” or isolation area, there was no requirement for staff to change PPE between resident rooms within the secure unit; staff simply had to remove PPE before “exiting the ‘isolation area.’” P. Br. at 14; P. Ex. 7 at 27-28.

The guidance cited by Petitioner does not speak to the specific situation in this case, however, where the facility housed both COVID-positive and COVID-negative residents within the same unit or area.  There is no indication the guidance cited by Petitioner was intended to cover situations where an isolation area included a mix of COVID-positive and COVID-negative residents.  That guidance is therefore not dispositive.

The CDC guidance that afforded facilities the flexibility to keep COVID-positive and COVID-negative residents within the same unit did not further specify how to maintain precautions while treating the mix of residents in that unit.  *See* CMS Ex. 10 at 1 (Administrator’s email to surveyor expressly recognizing that the CDC guidance “does not specifically address the use of PPE.”).  Without guidance addressing the specific circumstances in this case, the burden was on Petitioner to justify departing from the general guidance to change or disinfect PPE “between uses.” CMS Ex. 5 at 8 (“Put on a clean isolation gown upon entry into patient room or area.”); *see also* CMS Ex. 6 at 6 (infection control pathway for surveyors indicating PPE should be removed appropriately and discarded “after resident care, prior to leaving room.”).  But the record does not show that Petitioner even considered the risks to R1 of allowing staff to continue using the same PPE compared to other possible alternatives; staff simply treated R1 just as it did others who were COVID positive.9 Petitioner does not dispute that failing to change or disinfect PPE increased R1’s risk of contracting COVID-19.  Petitioner ought to have changed or disinfected PPE “between” caring for COVID-positive residents and R1 in the secure unit.  By failing to do so, Petitioner did not do its part “to help prevent” the transmission of COVID-19, as required by statute and regulation.  42 U.S.C. § 1395i-3(d)(3)(A); 42 C.F.R. § 483.80.

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As a final matter, Petitioner raised the issue of extended use of PPE at the hearing and in its briefs.  Tr. 41-42; P. Br. at 14-16.  CDC and state health care guidance acknowledged that, in times of PPE shortages, facilities ought to “optimize” their PPE supply, which may include “extended use” of respirators, facemasks, and eye protection, and limiting gown use to high-contact care activities and those where splashes or sprays are anticipated.  CMS Ex. 5 at 1-2; P. Ex. 7 at 47.  But Petitioner submits no evidence that the facility was experiencing shortages of PPE or engaging in the practice of extended use PPE at the time of the survey.  As the surveyor testified, Petitioner did not give a reason for reusing PPE for R1 during the survey.  Tr. at 42, 56.  As a result, Petitioner’s arguments regarding extended use of PPE do not justify staff’s failure to change PPE in this case.

By failing to change PPE in between caring for COVID-positive residents and R1, Petitioner was not in substantial compliance.  42 U.S.C. § 1395i-3(d)(3)(A); 42 C.F.R. § 483.80.

*****CMS’s finding of immediate jeopardy is clearly erroneous.*****CMS determined that the facility’s noncompliance with the infection control regulation posed immediate jeopardy to resident health and safety.  CMS’s determination as to the level of a facility’s substantial noncompliance, which includes an immediate jeopardy finding, must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c)(2).  Immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  Because R1 remained COVID-negative and there were no allegations of actual harm for R1, CMS’s immediate jeopardy determination must be supported by a finding that the facility’s noncompliance was *likely to cause* serious harm.  Additionally, as explained above, the facility’s failure to remove R1 from the secure unit did not amount to a violation of the infection control regulation because the facility had documented the reasons for keeping R1 in the unit and those reasons were consistent with CDC guidance at the time.  Failing to remove R1 from the secure unit, therefore, provides no basis to uphold CMS’s immediate jeopardy determination.

CMS’s other allegation of noncompliance with the infection control regulation involved staff’s failure to change or disinfect PPE before treating R1.  As noted above, the record supports that staff’s failure to change or disinfect PPE had the potential for more than minimal harm because the failure increased R1’s risk of contracting COVID-19 via potentially infectious particles lingering on PPE.  CMS Ex. 5 at 2 (CDC guidance recognizing that person-to-person transmission from contact with contaminated surfaces, like contaminated PPE, “might occur.”); P. Ex. 12 at 1; ALJ Ex. 1 at 2.

I must determine whether that failure to change or disinfect PPE was also likely to cause serious harm.  On that issue, I will accept that R1 was likely to suffer serious harm if he

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contracted COVID-19 given his age. 10 P. Br. at 21 (acknowledging that “[i]t is well-established that residents of a nursing facility are, as a whole, a particularly vulnerable population when it comes to COVID-19.”); P. Ex. 7 at 31 (“Because of their congregate nature and residents served (older adults often with underlying medical conditions), [nursing facility] populations are at the highest risk of serious illness caused by COVID-19.”).  Even so, the record does not support that the facility’s practice was *likely* *to cause R1 to contract COVID-19*.****

For the likelihood of COVID transmission based on staff’s failure to change PPE, CDC guidance in the record merely observed *the potential* for person-to-person transmission from contact with contaminated surfaces—like contaminated PPE—indicating that it simply “might occur,” but only after “self-delivery to the eyes, nose, or mouth.” CMS Ex. 5 at 2.  The guidance does not indicate *likelihood* or state that transmission from contact with contaminated surfaces was probable.  Significantly, CDC further advised in October 2020 that spread from “touching surfaces” is “not thought to be a common way that COVID-19 spreads.” ALJ Ex. 1 at 2.  Therefore, CDC guidance support that R1’s risk of contracting COVID-19 from potential contact with contaminated PPE was not high.

As far as the most common way to spread COVID-19, CDC guidance in the record stated:

Current data suggest person-to-person transmission most commonly happens during close exposure to a person infected with the virus that causes COVID-19, primarily via respiratory droplets produced when the infected person speaks, coughs, or sneezes.  Droplets can land in the mouths, noses, or eyes of people who are nearby or possibly be inhaled into the lungs of those within close proximity.

CMS Ex. 5 at 2; *see* ALJ Ex. 1 at 1.  This is consistent with WHO guidance, which stated that COVID-19 “spreads more easily” in crowded places, close-contact settings (especially where people have conversations very near each other), and confined and enclosed spaces with poor ventilation.  P. Ex. 12 at 4.  Notably absent from the WHO guidance for spreading COVID-19 “more easily” was touching contaminated surfaces.  Therefore, R1’s risk of contracting COVID-19—from interactions with staff—was thus

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greatest during close exposures to respiratory droplets from an infected staff member.  But there is no dispute that staff continued to use all recommended types of COVID-19 PPE for the care of residents in the secure unit, even if staff did not disinfect that PPE before treating R1.  Continuing to take such transmission-based precautions for COVID-19, including using facemasks and respirators, would have helped reduce the risk of transmission from respiratory secretions.  As the CDC explained, “having [an] infected person wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions” is a form of “[s]ource control” which “might help reduce the risk of transmission.” CMS Ex. 5 at 2; *see also* CMS Ex. 6 at 4 (“[Healthcare personnel] should use all recommended COVID-19 PPE for the care of all residents on affected units . . . .”); P. Ex. 12 at 6 (stating that a basic precaution to lower risk of contracting COVID-19 is to “[w]ear a mask.”); ALJ Ex. 1 at 2 (“Cover your mouth and nose with a mask when around others.  This helps reduce the risk of [COVID-19] spread both by close contact and by airborne transmission.”).

Overall, the CDC and WHO guidance reviewed above lends strong support to the conclusion that R1’s risk of contracting COVID-19 from potential contact with contaminated PPE was not high and so his risk of serious harm from contracting COVID-19 must also be low.  Therefore, I conclude that the immediate jeopardy determination in this case is clearly erroneous.

**Advance Directives Deficiency**

*****Petitioner documented in R20’s medical record that R20 had an advance directive not to be resuscitated.  However, the advance directive that Petitioner documented to R20’s medical record was invalid because R20 had not signed it and the advance directive was witnessed by individuals who were not legally permitted to serve as witnesses.*****R20 was admitted to Petitioner’s facility as a resident on March 30, 2020.  CMS Ex. 30 at 1.  Also on March 30, 2020, R20’s son signed a Texas Department of State Health Services Out-of-Hospital-Do-Not-Resuscitate (OOH-DNR) form.  CMS Ex. 31.  On the OOH-DNR form, R20’s son indicated that certain resuscitation measures should not be initiated or continued for R20.  CMS Ex. 31 at 1.  R20’s son indicated on the form that he was R20’s agent with a medical power of attorney (POA).  CMS Ex. 31 at 1.

Petitioner prominently indicated in R20’s medical record that her advance directive was the following: “DNR (Do Not Resuscitate).” CMS Ex. 30 at 2.  As explained below, Petitioner posted this DNR status to R20’s medical record despite the fact that R20’s son was not authorized to sign the OOH-DNR form and the witnesses who signed the form were legally disqualified to serve as witnesses.

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R20’s medical POA form is in the record and R20 signed it on March 30, 2020 (i.e., the same day Petitioner admitted R20 to the facility and the same day R20’s son signed the OOH-DNR).  CMS Ex. 31.  The form states that the medical POA takes effect if R20 becomes unable to make her own health care decisions and “this fact is certified by [R20’s] physician.” CMS Ex. 31 at 2.  If the physician makes such a certification, then the physician must notify R20’s agents that such a certification has taken place.  CMS Ex. 31 at 1.  In the medical POA, R20 appointed two individuals, R20’s son and step-daughter, to act as R20’s agents to make all health care decisions if R20’s physician certifies that R20 becomes unable to make her own health care decisions.  CMS Ex. 32 at 1; *see also* CMS Ex. 30 at 2 (indicating R20’s relationship to the appointed individuals).

The record contains no document showing that R20’s physician certified R20 as unable to make her own health care decisions or that the physician notified R20’s son of such a certification.  Without that documentation, R20’s son was not authorized to sign the OOH-DNR on March 30, 2020.

Even if R20’s physician had certified that R20 could not make her own health care decisions, the OOH-DNR was invalid because it was signed by two witnesses who were both employees of Petitioner’s facility.  CMS Ex. 31 at 1; *see also* CMS Ex. 8 (list of facility employees).  The instructions for the OOH-DNR form explain that at least one of the two witnesses required for a valid form must be a person who is *not* “an employee of a health care facility in which the person is a patient if the employee is providing direct patient care to the patient.” CMS Ex. 31 at 2.  The state agency survey revealed that the facility employees who witnessed the OOH-DNR both provided patient care to R20.  CMS Ex. 1 at 5-6.  Petitioner did not dispute this finding in the SOD.  *See* P. Ex. 1 at 4-5; P. Ex. 5 at 4-5.

*****Petitioner documented in R21’s medical record that R21 had an advance directive not to be resuscitated.  However, the advance directive that Petitioner documented to Petitioner’s medical record was invalid because R21 had not signed it.*****R21 was admitted to Petitioner’s facility as a resident on June 15, 2017.  CMS Ex. 33 at 1.  On November 15, 2017, R21’s sister, S.C., signed an OOH-DNR, indicating that she was R21’s agent under a medical POA and was serving as a “legal guardian, agent or proxy on behalf of the adult person who is incompetent or otherwise incapable of communication.” CMS Ex. 34 at 2; *see also* CMS Ex. 33 at 1 (indicating S.C. was R21’s sister).  There is no copy of a medical POA for R21 in the record.

Petitioner prominently indicated in R21’s medical record that her advance directive was the following: “DNR (Do Not Resuscitate).” CMS Ex. 33 at 2.  Petitioner did this despite the fact that there was no documentation in the record supporting that R21 was

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“incompetent or otherwise incapable of communication” or unable to complete the OOH-DNR form for herself.  Indeed, according to the SOD, R21’s quarterly minimum data set (MDS), from around the time of the survey, showed R21 with “intact cognition.” CMS Ex. 1 at 4-5 (indicating MDS was dated November 20, 2020).  Petitioner did not dispute this finding in the SOD.  *See* P. Ex. 1 at 4-5; P. Ex. 5 at 4-5.

*****Petitioner was not in substantial compliance with 42 C.F.R. §*** ***483.10(c)(6), (g)(12) because it failed to ensure the advance directives for R20 and R21 were valid before documenting those directives in the clinical records for those residents.*********In this case, it is undisputed that Petitioner documented in R20’s and R21’s medical record that there was a DNR advance directive despite the fact that the OOH-DNR forms for each resident were invalid.  CMS Ex. 30 at 2; CMS Ex. 33 at 2.

CMS argues that Petitioner was not in substantial compliance with the regulations concerning advance directives because Petitioner failed to ensure the validity of the OOH-DNR forms, which “put [R20] at risk of not receiving life-saving measures or receiving resuscitation against her wishes” and “left [R21’s] DNR status in a state of confusion.” CMS Br. at 8, 17-18.

In response, Petitioner argues that 42 C.F.R. § 483.10(c)(6), (8) and (g)(12) merely require a facility *to inform* a resident or the resident’s responsible party of the right to formulate an advance directive and do not require a facility to give legal advice as to whether the right person executed the document or whether the right witnesses certified the signature.  P. Br. at 17; P. Ex. 1 at 4-5; P. Ex. 5 at 4-5.  Petitioner argues that it did inform both residents and their family members regarding the right to formulate an advance directive, as evidenced by the initiation of the advance directive documentation.  CMS Ex. 1 at 3-4.  Petitioner adds that it was not cited for a failure to maintain a cardiopulmonary resuscitation (CPR) status system or for a failure to administer CPR due to an invalid advance directive or OOH-DNR form.  P. Br. at 19.

Petitioner misunderstands the relevant requirements, and its selective reading of the cited regulations is unpersuasive.  The Act requires SNFs to “protect and promote” the rights of each resident, including the right to be fully informed in advance about care and treatment, including any changes in the care or treatment that may affect the resident’s well-being, and to participate in planning and in changing care and treatment.  42 U.S.C. § 1395i-3(c)(1)(A)(i).  The Act also requires SNFs to “document in a prominent part of the individual’s current medical record whether or not **the individual has** **executed** an advance directive.” 42 U.S.C. §§ 1395i-3(c)(1)(E), 1395cc(f)(1)(B) (emphasis added).  The Act defines “advance directive” as a “written instruction, such as a living will or durable power of attorney for health care, **recognized under State law** . . . and relating to

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the provision of such care when the individual is incapacitated.” 42 U.S.C. § 1395cc(f)(3) (emphasis added); *see also* 42 C.F.R. § 489.100.

To effectuate the requirements of the Act, the Secretary promulgated the resident rights regulation that states “the resident has the right to be informed of, and participate in, his or her treatment, including the right to request, refuse, and/or discontinue treatment, to participate in or refuse to participate in experimental research, and to formulate an advance directive.” 42 C.F.R. § 483.10(c)(6).  Further, the resident rights regulation requires SNFs to comply with the requirements specified in 42 C.F.R. Part 489, Subpart I (Advance Directives), which states that SNFs “must maintain written policies and procedures concerning advance directives with respect to all adult individuals receiving medical care.” 42 C.F.R. §§ 483.10(g)(12), 489.102(a).  In particular, SNFs must:

Document in a prominent part of the individual’s current medical record . . . whether or not **the individual has executed** an advance directive.

42 C.F.R. § 489.102(a)(2) (emphasis added).

Petitioner’s argument, summarized above, overlooks the requirement quoted directly above, that SNFs must “[d]ocument in a prominent part of the individual’s current medical record . . . whether or not the individual has executed an advance directive.” 42 C.F.R. §§ 483.10(g)(12), 489.102(a)(2).  This requirement, which is also clearly stated in statute, necessarily requires an SNF to make an independent evaluation as to whether an advance directive was executed by the resident and is valid under state law.

The requirement that an SNF evaluate the validity of advance directives is consistent with an SNF’s obligation to provide life-saving services to residents.  As stated in the regulations, SNFs must ensure that:

Personnel provide basic life support, including CPR, to a resident requiring such emergency care prior to the arrival of emergency medical personnel and subject to related physician orders and the resident’s advance directives.

42 C.F.R. § 483.24(a)(3).  If the facility decides to remain ignorant as to the validity of an advance directive, its staff may fail to provide CPR when, as in this case, advance directives were not executed by the residents and were invalid.  As explained in a case decision, such a failure would be a deficiency under 42 C.F.R. § 483.24(a)(3).

[F]or any resident who has not elected in a DNR order or other instrument to forego emergency resuscitation, CPR is an inherently “necessary” service. . . . It follows that an

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unwarranted failure to perform CPR has the potential for more than minimal harm – that being the evisceration of any chance of survival and recovery.

*North Las Vegas Care Ctr.*, DAB No. 2946 at 7 (2019).

Therefore, while a facility must not provide basic life support when a resident has executed an advance directive, the facility must provide basic life support if there is no valid advance directive.  Given these overlapping responsibilities, it is clear that Petitioner needed to ensure that R20 and R21 had executed valid advance directives before prominently posting “DNR” in their medical records.  Petitioner failed to do so here.  Therefore, I conclude Petitioner’s failure constituted noncompliance.11

**CMP Duration and Amount**

*****Petitioner did not dispute the duration of the per-day CMPs imposed by CMS.  Therefore, I uphold CMS’s determination that penalties are properly imposed from December 1, 2020 through December 30, 2020*****.****CMS imposed on Petitioner a $9,500 per-day CMP for four days, from December 1, 2020, through December 4, 2020, and a $350 per-day CMP for 26 days from December 5, 2020, through December 30, 2020.  CMS Ex. 2 at 2.  Although Petitioner disputed the deficiencies underlying the imposition of penalties, Petitioner did not expressly argue that it returned to substantial compliance earlier than December 30, 2020.  *See* P. Br. at 9 (Petitioner identified the issues in this case to include “[w]hether CMS legitimately imposed a CMP, and whether the CMP amount was reasonable,” but not whether the duration of the CMPs was correct).

An SNF bears the burden of showing that its noncompliance was of shorter duration than alleged by CMS.  *Owensboro Place & Rehab. Ctr.*,DAB No. 2397 at 12 (2011) (citing *Kenton Healthcare, LLC*, DAB No. 2186 at 24-25 (2008); *Lake Mary Health Care*, DAB No. 2081 at 30 (2007)).  In this case, Petitioner has made no attempt to show the duration should be shorter.  Therefore, I accept the duration as found by CMS.

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*****Because CMS’s determination that Petitioner immediately jeopardized the health and safety of residents was clearly erroneous, the $9,500 per-day CMP that CMS imposed for alleged immediate-jeopardy noncompliance must be reduced.  A $350 per-day CMP for the entire period of noncompliance, from December 1, 2020, through December 30, 2020, is appropriate under the relevant statutory and regulatory factors for setting the amount of a CMP.*****When determining whether the amount of a CMP is appropriate, I apply the factors listed in 42 C.F.R. § 488.438(f):1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  *See*42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(e)(3).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 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.  *See*42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at sections 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); *see also* 42 C.F.R. § 488.438(e)(2) and (3); *Alexandria Place*, DAB No. 2245 at 27 (2009); *Kenton Healthcare, LLC*, DAB No. 2186 at 28-29 (2008).

Petitioner faults CMS for failing to provide “the required evidence regarding the factors considered in calculating the CMP.” P. Br. at 28 (emphasis omitted).  Petitioner misunderstands the burdens on this issue.  Prior case decisions explain that “*there is a presumption* that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS.  Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it.” *Coquina Ctr.*, DAB No. 1860 at 32 (2002) (emphasis added).  Thus, the burden is not on CMS to explain its decision-making process or to explain the relative weights assigned to each deficiency to support the CMP amounts imposed.  Once the facility contends that a regulatory factor does not support the CMP amount, CMS must then produce evidence as to that factor.  *Coquina Ctr.*, DAB No. 1860 at 32.

Here, Petitioner does not specifically explain why the CMP amounts imposed are unreasonable based on consideration of the regulatory factors.  However, because I found CMS’s immediate jeopardy determination clearly erroneous, I must reduce the CMP amount as to December 1, 2020 through December 4, 2020.  Therefore, I consider the factors in light of the evidence of record.

Page 25

Based on a review of the factors below, I conclude that CMS’s imposition of a $350 per-day penalty was appropriate from December 5, 2020 through December 30, 2020.  As a result, it is appropriate to also impose that penalty amount for the period of December 1, 2020 through December 4, 2020.  I briefly discuss the factors below.

**Facility’s History of Non-Compliance:**CMS did not submit evidence of Petitioner’s history of noncompliance.

**Financial Condition of the Facility:**Petitioner does not assert that its financial condition justifies a reduction in the CMP amount.  Therefore, this is not a factor requiring consideration.

**Scope and Severity of Deficiencies and Relationship Between Deficiencies:**  CMS originally determined that Petitioner’s substantial noncompliance with 42 C.F.R. § 483.80(a) was at the immediate jeopardy severity level.  It also determined that the substantial noncompliance with 42 C.F.R. § 483.10(c)(6), (g)(12) posed a risk for more than minimal harm without causing actual harm.  Because I concluded that CMS’s immediate jeopardy determination was clearly erroneous, Petitioner’s noncompliance with 42 C.F.R. § 483.80(a) must be considered much less severe than CMS alleged. 
Indeed, facility staff’s failure to change PPE simply had *the potential* to cause more than minimal harm to R1 as it modestly increased his risk of contracting COVID-19.  Further, the facility’s noncompliance with the advance directive regulation also had the potential for causing more than minimal harm.  Petitioner deprived residents of the right to determine their own care, which may have resulted in the facility withholding life-saving basic life support measures.  The Act required Petitioner to “protect and promote” that right.  Further, had one of the residents needed CPR at a time before the survey, that resident may have died without intervention from staff.

**Culpability:**  The facility’s culpability with respect to the two deficiencies also supports the $350 CMP amount imposed.  The record supports that the facility neglected to even consider changing or disinfecting PPE before treating R1 even though he was a COVID-negative resident in the facility’s designated COVID-19 zone.  As for the advance directives, Petitioner’s failure to ensure the OOH-DNR forms were properly executed, despite being significantly involved in the completion of those forms, shows a disregard for ensuring that residents receive care in medical emergencies consistent with their wishes.

**CMP Amount:**  CMS imposed a $350 per-day CMP for the period when Petitioner was in noncompliance below the immediate jeopardy level of severity.  The potential penalty range for this noncompliance was from $112 to $6,695 per day.  45 C.F.R. § 102.3; 85 Fed. Reg. at 2880.  A CMP amount of $350 per day is low and near the minimum $112 per-day amount.  Based on consideration of the factors above, CMS was well within

Page 26

its authority to impose a $350 per-day CMP for the period of December 5, 2020 through December 30, 2020.  In light of my conclusion that CMS’s determination of immediate jeopardy was clearly erroneous, I must reduce the $9,500 per-day CMP imposed from December 1, 2020 through December 4, 2020, to an amount in the range for less serious noncompliance.  A reduction to $350 per day for December 1, 2020 through December 4, 2020, is appropriate because it reflects CMS’s view as to the penalty necessary for the non-immediate jeopardy deficiencies in this case.  CMS Ex. 1 at 9 (SOD providing that “[w]hile the IJ was removed on 12/05/2020, the facility remained out of compliance at a severity of potential for more than minimal harm that is not immediate jeopardy with a scope identified as pattern . . . .”); CMS Ex. 2 at 2 (imposing a $350 per day CMP following removal of immediate jeopardy conditions).

VI.  Conclusion

I conclude Petitioner was out of substantial compliance with Medicare requirements, but that CMS’s immediate jeopardy determination was clearly erroneous.  As a result, the CMP amount imposed based on the immediate jeopardy determination is reduced.  I conclude that the imposition of a $350 per-day CMP for non-immediate-jeopardy noncompliance from December 1, 2020 through December 30, 2020, is appropriate under the relevant statutory and regulatory factors.  The total CMP amount is $10,500.

Endnotes

1  It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.” 42 U.S.C. § 1395i-3(f)(1).

2  All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.

3  State agencies designate the scope and severity level using a matrix published in the State Operations Manual, chap. 7, § 7400.5 (Sep. 10, 2010).  Scope and severity levels of A, B, or C are deficiencies for which CMS cannot impose enforcement remedies.  Scope and severity levels of D, E, or F are deficiencies that present no actual harm, but have the potential for more than minimal harm that do not amount to immediate jeopardy.  Scope and severity levels of G, H, or I indicate deficiencies that involve actual harm that do not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.

4  The case was originally set for a hearing on September 22, 2022, but the hearing was rescheduled earlier, to August 22, 2022, after counsel for Petitioner filed an unopposed motion to change the date of the hearing based on a conflict with a trial in state court.

5  I directed the parties to include all arguments they wanted me to consider in their post-hearing briefs and that the parties could not cross-reference their prehearing briefs.  Tr. 60-61.

6  CMS did not cross-examine Petitioner’s witnesses.  Further, Petitioner’s witnesses did not testify inconsistently with the record.  Therefore, I give weight to the written direct testimony of those witnesses cited above concerning R1.

7  CMS revised the Part 483 regulations concerning SNF conditions of participation in 2016.  Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections).  The infection prevention and control regulation currently promulgated in 42 C.F.R. § 483.80was formerly found in 42 C.F.R. § 483.65.  In assessing compliance under §483.80 in this case, I consider case decisions analyzing the former § 483.65.

8  For example, Petitioner did not provide written direct testimony from its staff refuting the surveyor’s observations.

9  Petitioner does not argue that staff could not, as a practical matter, change PPE between caring for residents, which I recognize may have been more challenging taking the circumstances in this case into account, namely caring for a COVID-negative resident who was kept in the hot zone with other COVID-positive residents who tended to wander and were noncompliant with mask-wearing.  But Petitioner still could have minimized the risk to R1 by relocating either his room and/or that unit’s sole PPE changing room so that they could be closer together.  Petitioner also could have instructed its staff to provide care to R1 first, before moving on to care for the remaining residents who were COVID-positive and who might contaminate the PPE.

10  I also acknowledge CMS’s argument that R1 was at risk of serious harm if he contracted COVID-19 because of his tongue cancer (even if I do not give any weight to the surveyor’s opinion on the issue, after she conceded that she was unqualified to opine on such matters).  CMS Br. at 15; CMS Ex. 12 at 1; Tr. at 37.  The argument is ultimately irrelevant because, even accepting that R1 would suffer serious harm if he contracted COVID-19 given his diagnosis, the evidence does not show that the facility’s noncompliance was *likely to cause* R1 to contract COVID-19.

11  Petitioner’s staff was heavily involved in the formulation of the two advance directives at issue.  R20’s OOH-DNR and medical POA forms were both executed on the same day R20 was admitted to Petitioner’s facility.  CMS Ex. 30 at 1; CMS Ex. 31 at 1.  Two staff members witnessed the signatures for R20’s OOH-DNR form while another staff member witnessed the signature for R21’s OOH-DNR form.  Petitioner cannot now say that its only involvement with the advance directives was to make the residents aware of their right to provide an advance directive.
  
          /s/
        Scott Anderson

                      Administrative Law Judge Back to top
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