Derry Center for Rehabilitation & Healthcare, DAB CR6530 (2024)

DECISION

Petitioner, Derry Center for Rehabilitation & Healthcare, challenges the determination by Respondent, the Centers for Medicare & Medicaid Services (CMS), that it was not in substantial compliance with Medicare program participation requirements.  Petitioner also challenges CMS’s imposition of a $22,320 per-instance civil money penalty (CMP) as unreasonable.  As explained herein, I conclude Petitioner did not substantially comply with the Medicare participation requirement at 42 C.F.R. § 483.80(a)(1) and find the per-instance CMP reasonable.

I.     Background

Petitioner is a skilled nursing facility (SNF) located in Derry, New Hampshire participating in the Medicare program.  CMS Exhibit (Ex.) 1 at 1.  Surveyors from the New Hampshire Department of Health and Human Services (NHDHS or state agency) completed a COVID-19 focused infection control survey at Petitioner’s facility on May 19, 2020.  CMS Ex. 2 at 1;1 Hearing Transcript (Tr.) at 15.  The surveyors found the

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facility was not in substantial compliance with the infection control provisions at 42 C.F.R. § 483.80(a)(1), (2), (4), (e), and (f) (Tag F880).  CMS Ex. 2 at 1.  NHDHS cited this deficiency at scope and severity level2 “J,” meaning an isolated instance of noncompliance that poses immediate jeopardy to resident health and safety.  CMS Ex. 2 at 1; SOM Ch. 7, § 7400.3.1 at 98-99.

On August 20, 2020, CMS notified Petitioner that based on the state agency’s findings, it found the facility to be out of substantial compliance and would impose a per-instance CMP of $22,320.  CMS Ex. 2 at 1-2.  CMS also advised Petitioner it had withdrawn approval of any nurse aide training and competency program (NATCEP) as of May 19, 2020.  Id. at 3; CMS Ex. 3 at 15.  CMS notified Petitioner that based on a revisit survey conducted by NHDHS on July 21, 2020, it determined the facility had returned to substantial compliance on May 31, 2020.  CMS Ex. 2 at 1.

Petitioner timely sought a hearing before an Administrative Law Judge (ALJ) in the Civil Remedies Division to challenge CMS’s determination of noncompliance with program requirements and the imposition of a $22,320 per‑instance CMP.  P. Req. for Hearing.  Upon my designation to hear and decide this case, I issued an Acknowledgment and Pre‑hearing Order (Pre-hearing order) that established a briefing schedule and directed the parties to file pre-hearing submissions that included written direct testimony for all proposed witnesses, proposed exhibits, and pre-hearing briefs.

CMS filed a pre-hearing brief (CMS Br.) and 16 proposed exhibits (CMS Exs. 1-16), including written direct testimony for its sole witness.  Petitioner filed a pre‑hearing brief (P. Br.) and 11 proposed exhibits (P. Exs. 1-11), including the written direct testimony of three witnesses.  Both parties requested to cross-examine the opposing party’s witnesses.  CMS subsequently withdrew its request.

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II.    Hearing and Admission of Exhibits

On August 25, 2021, I held a hearing by videoconference to allow Petitioner to cross-examine CMS’s witness.  At the outset of the hearing, I ruled on the admissibility of the parties’ proposed exhibits.  Absent objection from Petitioner, I entered CMS Exhibits 1 through 16 into evidence.  Tr. at 7.  I overruled CMS’s objections to Petitioner’s exhibits and admitted Petitioner’s Exhibits 1 through 11.  Id. at 8-9.  The parties subsequently filed post-hearing briefs (CMS Closing Br. and P. Closing Br.).

III.   Issues

The issues presented are:

1. Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.80(a)(1), (a)(2), (a)(4), (e), and (f) (Tag F880); and
2. If Petitioner was not in substantial compliance with Medicare participation requirements, whether the $22,320 per-instance CMP selected by CMS is reasonable.

IV. Jurisdiction

I have jurisdiction to hear and decide this case.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

V. Statutory and Regulatory Authority for the Imposition of Penalties

The Social Security Act (Act) sets forth requirements for a SNF’s participation in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  42 U.S.C. § 1395i-3.  These implementing regulations are found at 42 C.F.R. Parts 483 and 488.

To participate in the Medicare program, a SNF like Petitioner must maintain substantial compliance with program participation requirements.  Substantial compliance means a deficiency “pose[s] no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by 42 U.S.C. § 1395i-3(b)-(d) and the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  Id.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose

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enforcement remedies against SNFs that are not in substantial compliance with program participation requirements.  42 U.S.C. § 1395i-3(h)(2).  The Secretary’s regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406. 

CMS has the authority to impose a per-instance civil money penalty (CMP) from $1,000 to $10,000, adjusted annually for inflation.  42 C.F.R. § 488.430(a); 42 C.F.R. § 488.408(d)(1)(iv); 45 C.F.R. Part 102.  In 2020, a per-instance CMP could range from $2,233 to $22,320.  85 Fed. Reg. 2869, 2886 (Jan. 17, 2020).

If CMS imposes a CMP based on a determination of noncompliance, a SNF may request a hearing before an ALJ to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, the facility may not appeal CMS’s choice of remedies.  42 C.F.R. § 488.408(g)(2).

VI.     Burdens of Proof and Persuasion 

Congress established that in administrative adjudications covered by the Administrative Procedures Act, “the proponent of a rule or order has the burden of proof[,]” except where otherwise provided by statute.  5 U.S.C. § 556(d).  The Act does not “otherwise provide[]” for allocation of the burden of proof or the quantum of evidence necessary to meet that burden in these proceedings.  It would therefore be reasonable to conclude that CMS, the agency that propounded the regulations implementing its enforcement authority under the Act, bears the burden of proof and persuasion to justify imposition of penalties authorized by the Act.

Nevertheless, the Departmental Appeals Board (Board) has imposed a burden-shifting regime in cases involving the imposition of enforcement penalties against providers whose appeals are adjudicated under 42 C.F.R. Part 498.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d sub nom. Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); VITAS Healthcare Corp. of Calif., DAB No. 1782 at 4 (2001); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom. Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

Under that regime, CMS has the burden to come forward with evidence sufficient to make a prima facie showing3 it had a basis for imposing a remedy.  In Hillman, the Board identified the elements it believed necessary for CMS to make such a showing:

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[CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges [CMS’s] findings, [CMS] must come forward with evidence of the basis for its determination, including the factual findings on which [CMS] is relying and, if [CMS] has determined that a condition of participation was not met, [CMS’s] evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611 at 8.

Once CMS makes a prima facie showing of noncompliance, Petitioner bears the burden of persuasion and must prove by a preponderance of the evidence of record that it substantially complied with statutory and regulatory requirements.  See Batavia, DAB No. 1911.

To date, federal district and circuit courts have declined to disturb this burden-shifting regime on due process or other grounds.4  See, e.g., Hillman, DAB No. 1611, aff’d sub nom. Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d sub nom. Fairfax Nursing Home v. U.S. Dep’t of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003); Batavia, DAB No. 1911, aff’d sub nom. Batavia, 143 F. App’x 664.  Until such judicial scrutiny demands otherwise, and absent modification of the Act or CMS’s implementing regulations, I apply the Board’s burden-shifting regime.

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VII.    Discussion

1. Legal framework for infection prevention and control

The Act and its implementing regulation require SNFs like Petitioner to “[e]stablish 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); 42 C.F.R. § 483.80.  At minimum, a facility’s infection control policy must satisfy the following requirements:

(a)  Infection prevention and control program.  The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:
(1)  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 conducted according to § 483.70(e) and following accepted national standards;
(2)  Written standards, policies, and procedures for the program, which must include, but are not limited to:  
(i)    A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility; 
(ii)   When and to whom possible incidents of communicable disease or infections should be reported; 
(iii)  Standard and transmission-based precautions to be followed  to prevent spread of infections; 
(iv)  When and how isolation should be used for a resident;   including but not limited to:
(A)  The type and duration of the isolation, depending upon the infectious agent or organism involved, and 
(B)   A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.  
(v)   The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and 
(vi)  The hand hygiene procedures to be followed by staff  involved in direct resident contact.

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*        *        *

(4)  A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility.

*        *        *

(e)  Linens.  Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.
(f)  Annual review.  The facility will conduct an annual review of its IPCP and update their program, as necessary.

42 C.F.R. § 483.80(a)(1), (a)(2), (a)(4), (e), (f).

The regulation does not mandate specific standards and measures but rather grants facilities discretion to develop and implement infection control protocols consistent with professionally recognized standards of nursing care.  Golden Living Ctr. – Superior, DAB No. 2768 at 5 (2017).  The drafters of the regulation believed SNFs needed “the flexibility to determine which national standard they are going to follow. . . .  Although [they were] not requiring that LTC facilities follow the CDC guidelines, [they] agree[d] with the commenters that the CDC is an excellent resource for guidelines . . . and encourage[d] LTC facilities to consider the CDC guidelines.”  81 Fed. Reg. 68,688, 68,808 (Oct. 4, 2016).

Upon establishing such policies and protocols, a facility is then required to implement those protocols and ensure they are effective.  42 C.F.R. § 483.80(a)(1); Golden Living, DAB No. 2768 at 7-8.  A facility is not in substantial compliance with participation requirements when it fails to follow standard precautions and isolation control procedures specified in its own infection control policies.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13 (2014).

2. Applicable guidance

While sub-regulatory guidance cannot provide an independent basis to impose substantive legal standards, see generally Azar v. Allina, 587 U.S. 566, the applicable regulation requires facilities to develop infection control protocols that are consistent with “accepted national standards” for infection control.  42 C.F.R. § 483.80(a)(1); Golden Living, DAB No. 2768 at 7-8.  There is no dispute that guidance provided by CMS, the Centers for Disease Control (CDC), and state agencies constitute accepted national standards.  Indeed, Petitioner’s COVID-19 policy explicitly states the facility would follow recommendations from the CDC and the New Hampshire Department of Health (NHDOH) to prepare for and respond to the COVID-19 pandemic.  CMS Ex. 5 at 36.  Below, I set forth recommendations from CMS, the CDC, and the NHDOH

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regarding the provision of care to nursing home residents during the COVID-19 pandemic applicable at the time of the survey.

1. CDC guidance on the use of Standard and Transmission-Based Precautions

In 2007, the CDC issued a revised “Guideline for Isolation Precautions” setting forth measures healthcare providers should apply to prevent the transmission of infectious diseases in all healthcare settings.  CMS Ex. 9 at 1.  The CDC revised this guideline to address the emergence of new pathogens and because of its prior success recommending evidence-based updates to standard precautions used in healthcare settings.  Id. at 8.

The CDC identified two tiers of precautions to prevent transmission of infectious agents:  Standard Precautions and Transmission-Based Precautions.  Id. at 68.  Standard Precautions were to be applied to the care of all patients in all settings and were “based on the principle that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents.”  Id.  Application of Standard Precautions included hand hygiene and use of gloves, gowns, masks, eye protection or a face shield, depending on the anticipated level of exposure.  Id. 

The CDC recommended implementation of Transmission-Based Precautions “for patients who are known or suspected to be infected or colonized with infectious agents, including certain epidemiologically important pathogens, which require additional control measures to effectively prevent transmission.”  Id.  These additional control measures are categorized as Contact, Droplet, and Airborne Precautions.  Id. at 71.

Contact Precautions “are intended to prevent transmission of infectious agents . . . . [and] also apply where the presence of excessive wound drainage, fecal incontinence, or other discharges from the body suggest an increased potential for extensive environmental contamination and risk of transmission. . . .”  Id. at 72.  Care of patients on Contact Precautions required healthcare practitioners to “wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient’s environment” as well as “[d]onning PPE upon room entry and discarding before exiting the patient room . . . .”  Id. 

Droplet Precautions “are intended to prevent transmission of pathogens spread through close respiratory or mucous membrane contact with respiratory secretions” and required healthcare practitioners to wear a mask “generally donned upon room entry” “for close contact with infectious patient[.]”  Id. at 72-73.Airborne Precautions “prevent transmission of infectious agents that remain infectious over long distances when suspended in the air” and required healthcare practitioners to “wear a mask or respirator,

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depending on the disease-specific recommendations . . . that is donned prior to room entry.”  Id. at 73.

The CDC advised use of Transmission-Based Precautions when Standard Precautions would not interrupt a disease’s route of transmission.  Id. at 72.  It recommended Transmission-Based Precautions to remain in effect “while the risk for transmission of the infectious agent persists or for the duration of the illness . . . .” Id. at 74.

2. April 2020 CMS and CDC guidance to long-term care facilities

On April 2, 2020, CMS and the CDC released guidelines to long-term facilities to minimize the spread of COVID-19.5  CMS Ex. 8 at 1-4.  They recommended use of “additional infection prevention and control practices during the COVID-19 pandemic, along with standard practices recommended as part of routine delivery to all patients.”  Id. at 12; see CMS Exs. 10, 13.  The need for these measures emanated from the risk of transmission through unprotected exposure to symptomatic, asymptomatic, or pre-symptomatic patients.  CMS Ex. 13 at 5.  These additional measures included use of facemasks, the use of Standard and Transmission-Based Precautions, and educating healthcare practitioners on the appropriate use of PPE.  CMS Ex. 13 at 4; CMS Ex. 10 at 3, 5-7, 10.

On April 30, 2020, the CDC issued interim recommendations to healthcare personnel for infection prevention and control specific to the COVID-19 pandemic.  CMS Ex. 8 at 11‑28.  The agency recommended long-term care facilities train their staff on when to use PPE, what PPE was necessary, and how to properly don PPE.  Id. at 19.  It specified healthcare practitioners should wear a facemask “at all times while they are in the healthcare facility.”  CMS Ex. 10 at 3, 4; CMS Ex. 13 at 4.  The CDC instructed facilities to ensure “that if [staff] needs to touch or adjust their facemask . . . [,] they should perform hand hygiene immediately before and after.”  CMS Ex. 10 at 4; see also CMS Ex. 10 at 5 (“Attention should be paid to training and proper donning . . . of any PPE.”).  Application of additional measures would depend on a patient’s COVID-19 status.  CMS Ex. 8 at 14, 16-17.

Where healthcare practitioners had no reason to suspect a patient presenting for care to have COVID-19 based on symptoms and exposure history, they could follow Standard Precautions unless they suspected another disease that would require Transmission-Based Precautions.  Id. at 14.  For patients with a suspected or confirmed COVID-19 infection, the CDC recommended healthcare practitioners adhere to Standard Precautions and don a facemask, gown, gloves, and eye protection.  Id. at 19-20.

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Regarding cohorting, the CDC provided guidelines to establish a designated COVID-19 care unit for residents with confirmed COVID-19 diagnoses.  Id. at 25-26.  The CDC advised SNFs to create a “physically separate [unit] from other rooms or units housing residents without confirmed COVID-19.”  Id. at 25.  The CDC recommended they place “signage at the entrance to the COVID-19 unit that instructs [health care practitioners] they must wear eye protection and an N95 or higher-lever respirator (or facemask if a respirator is not available) at all times while on the unit.  Gowns and gloves should be added when entering resident rooms.”  Id. at 26.

More broadly, the CDC advised SNFs to ensure they trained staff on infection measures, including the proper use of PPE, and advised them to “use all recommended COVID-19 PPE for the care of [symptomatic and asymptomatic] residents on affected units (or facility-wide if cases are widespread).”  Id. at 26, 28.

The CDC also set forth guidance updated April 30, 2020 concerning when Transmission-Based Precautions could be discontinued for symptomatic COVID-19 patients based on whether healthcare practitioners employed a test-based or symptom-based strategy.  P. Ex. 2 at 1.  Under the symptom-based strategy, the CDC advised providers to keep symptomatic COVID-19 patients under Transmission-Based Precautions until at least three days passed since recovery (meaning resolution of fever without medication and improvement in respiratory symptoms) and at least 10 days had passed since the first appearance of symptoms.  Id.  Using the test-based strategy, providers could discontinue Transmission-Based Precautions where the patient exhibited resolution of fever without medication and improvement in respiratory symptoms and received negative results from a COVID-19 molecular assay test authorized for emergency use by the FDA.  Id. at 2.

For asymptomatic patients who tested positive for COVID-19, the CDC set forth guidelines for the discontinuation of Transmission-Based Precautions using either a time-based strategy or a test-based strategy.  Id.  Under the former, the CDC advised asymptomatic patients who tested positive for COVID-19 to remain under Transmission-Based Precautions until 10 days had passed since the date of the first positive COVID-19 test.  Id.  Under the latter, the CDC recommended maintaining Transmission-Based Precautions until the asymptomatic patient received at least two negative COVID-19 test results at least 24 hours apart.  Id. 

The CDC pointed out limitations under either method, noting that under the time-based strategy, viral shedding could persist beyond 10 days, while using the test-based strategy, prolonged detection of viral RNA could occur even though an infectious virus was not necessarily present.  Id.  The CDC recommended consultation with local infectious disease experts when deciding to discontinue Transmission-Based Precautions for patients whose infections could persist beyond 10 days, such as the severely immunocompromised.  Id.

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3. New Hampshire Department of Health guidance

On April 14, 2020, the NHDOH advised facilities like Petitioner that if a “resident is diagnosed with COVID-19 and you suspect that transmission may have occurred within your facility, then test all residents in that wing/unit regardless of symptoms.”  CMS Ex. 8 at 6.  The state agency recommended facility staff use full PPE for “every resident until 14 days have passed from identification of the confirmed case as long as no other positive residents or staff are identified.”  Id. 

3. Petitioner’s COVID-19 infection control policy

Petitioner’s policy required its employees to always wear a mask while in the facility.  CMS Ex. 5 at 34.  It required members of staff to ensure they were at least six feet away from others before removing their masks to eat or drink.  Id.  When in close contact with residents, the policy required staff to use “appropriate” PPE based on the procedure performed and the availability of PPE.  Id.  

The policy required facility staff to screen residents every shift for fever and respiratory symptoms and immediately isolate anyone exhibiting such signs.  Id. at 39.  Petitioner’s policy required employees to employ standard, contact, and droplet precautions, meaning use of a gown, gloves, face mask, and eye protection (face shield or goggles) for ill residents.”  Id. at 40.  For residents with confirmed COVID-19, the policy permitted staff to discontinue isolation precautions without testing if at least three days had passed since resolution of fever without medication and improvement of respiratory symptoms, and seven days had passed since the first appearance of symptoms.6  Id. at 39.

Petitioner’s policy defined an “outbreak” of COVID-19 to occur if the facility confirmed one or more cases of COVID-19 among residents and staff.  CMS Ex. 5 at 37; CMS Ex. 4.

4. Relevant facts

At the time of the survey, Petitioner housed 37 residents.  CMS Ex. 4 at 1; P. Ex. 7 ¶ 30.  Petitioner placed residents in either the west or east unit of its facility based on the resident’s COVID-19 status.  CMS Ex. 4 at 1; CMS Ex. 5 at 2.  Residents in the east unit did not exhibit COVID-19-related symptoms but were reportedly placed on precautions while waiting for re-testing results.  CMS Ex. 4 at 1.  Petitioner housed residents who tested positive for COVID-19 in the west unit, which at the time of the survey contained approximately 22 residents.  Id.; CMS Ex. 5.  One of those residents was Resident 1,

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whose diagnoses included chronic obstructive pulmonary disease, dementia, hypertension, and obesity.  CMS Ex. 7 at 2.  As a result, Resident 1 received oxygen therapy even before testing positive for COVID-19.  Tr. at 46; P. Ex. 3 at 9; CMS Ex. 7 at 12-16.

Petitioner placed Resident 1 in the COVID-19 unit under droplet precautions after she tested positive for COVID-19 on April 23, 2020.  P. Ex. 3 at 8-9.  Until May 15, 2020, Petitioner evaluated Resident 1 and recorded whether she displayed symptoms associated with COVID-19.  Id.; P. Ex. 4.  Petitioner’s records show Resident 1 to be afebrile (without fever) and identified no COVID-19 related symptom except for changes in oxygen saturation.  P. Ex. 3; P. Ex. 4; Tr. at 32-46.  Resident 1 tested positive for the COVID-19 viral antibody on May 13, 2020.  P. Ex. 3 at 1.

State surveyors Kristie Holtz and Karrie Johnson initiated an infection control survey at Petitioner’s facility on May 13, 2020.  CMS Ex. 4 at 1; Tr. at 14-15, 17.  At about 10:45 a.m., Surveyor Johnson observed LPN 17 providing leg care to Resident 1 in the COVID-19 unit while sitting on the floor in front of the resident.  CMS Ex. 1 at 4; CMS Ex. 4 at 1.  Surveyor Johnson observed Resident 1 did not wear a mask and that LPN 1 did not wear a gown, gloves, or face shield.  CMS Ex. 1 at 4. 

At about 10:50 a.m., Surveyor Johnson observed an individual she identified as “therapist LB” leave one unit to go to the other.  CMS Ex. 4 at 1.  According to the surveyors, Director of Nursing (DON) Doucet witnessed this incident and explained members of staff had to provide care in both units because of staffing issues.  Id. 

At about 11:00 a.m., Surveyor Holtz observed LPN 1 providing foot care to Resident 1, who was sitting in a chair, while sitting in front of the resident on the floor.  CMS Ex. 1 at 4; CMS Ex. 4 at 2; Tr. at 26.  From the entrance to Resident 1’s room, Surveyor Holtz observed LPN 1’s mask slipped below her nose.  CMS Ex. 1 at 4; CMS Ex. 4 at 2.  Surveyor Holtz observed LPN 1 care for Resident 1 for approximately two minutes and noted Resident 1 did not wear a mask and the nurse did not adjust her mask to cover her nose.  CMS Ex. 4 at 2; see also P. Ex. 7 at 4.

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5. Petitioner’s ancillary arguments have no merit.

I first address Petitioner’s attacks on the validity of the May 19, 2020 survey and the admissibility of statements attributed to Surveyor Johnson in the written record.  Petitioner contends the surveyors failed to comply with the State Operations Manual (SOM) because they did not review all reasonable documentation available to them, causing them to reach an erroneous conclusion.  P. Closing Br. at 21-22.  CMS responds that “alleged defects in the survey process do not invalidate adequately documented deficiencies.”  CMS Closing Br. at 23 n.6 (citing 42 C.F.R. § 488.318(b)(2)).

CMS is correct.  Inadequacies in survey performance do not relieve a facility from meeting the requirements of program participation or invalidate documented deficiencies.  42 C.F.R. § 488.318(b); Avon Nursing Home, DAB No. 2830 at 11-12 (2017) (internal citations omitted) (providing “allegations of inadequate survey performance are irrelevant to ALJ or Board review of CMS’s noncompliance and remedy determinations. . . . except to the extent that the state agency’s survey practices undermine the credibility of evidence that CMS identifies as supporting the noncompliance determination”); BGI Ret., LLC, DAB No. 2620 at 11 (2013) (“[A]lleged shortcomings or improprieties in the survey and enforcement process are generally irrelevant in this type of proceeding.”).  Petitioner’s attempt to undermine the findings of the surveyors by attacking the survey process are thus futile unless it can undermine the credibility of the evidence proffered by CMS to the extent I cannot rely on it.

In that vein, noting CMS did not offer Surveyor Johnson as a witness, Petitioner claims I should give no weight to statements and recorded observations attributed to Surveyor Johnson because they are inadmissible hearsay.  P. Closing Br. at 22-23 (citing Fed. R. Evid. 802).  That argument is without merit.  First, Petitioner waived any objection to the admission of documents containing Surveyor Johnson’s statements or recorded observations by failing to object to CMS’s proposed exhibits in the time allotted.  Pre-hearing Order § 8.  Second, Federal Rule of Evidence 802 cannot be used to bar the admission of evidence in these proceedings.  42 C.F.R. § 498.61 (stating “[e]vidence may be received at the hearing even though inadmissible under the rules of evidence applicable to court procedure”).  I must instead inquire “fully into all of the matters at issue[] and receive[] in evidence the testimony of witnesses and any documents that are relevant and material.”  42 C.F.R. § 498.60.  Petitioner does not claim Surveyor Johnson’s observations and statements are not relevant or material here.

Moreover, Petitioner did not need to rely on Federal Rule of Evidence 802 to negate the weight of Surveyor Johnson’s statements; it could have refuted the surveyor’s recorded statements with its own competent evidence.  It did not do so.  Here, DON Doucet accompanied Surveyor Johnson during the survey and subsequently provided written direct testimony.  CMS Ex. 4 at 1; P. Ex. 7.  If Petitioner wished to attack the accuracy and reliability of Surveyor Johnson’s observations, DON Doucet’s direct eyewitness

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testimony would have amply served that purpose.  Her declaration pointedly does not do so.

Finally, even though CMS did not proffer sworn testimony from Surveyor Johnson, Petitioner could nevertheless have sought the opportunity to cross-examine her by requesting a subpoena for her appearance at the hearing.  See 42 C.F.R. § 498.58.  It did not do so.  Absent inconsistencies in the record or conflicting testamentary evidence, I have no basis to find the hearsay statements by Surveyor Johnson unreliable.

6. Petitioner failed to substantially comply with 42 C.F.R. § 483.80 and 483.80(a)(1)8 when its staff failed to follow its own infection control policy while providing care to Resident 1.

CMS alleges Petitioner did not adequately implement its infection control program because a member of its nursing staff, LPN 1, failed to wear PPE correctly while providing care to Resident 1 in the facility’s COVID-19 unit.  CMS Br. at 2; CMS Closing Br. at 1-4, 16-19.  Specifically, Surveyor Holtz observed LPN 1 provide care to Resident 1 in the facility’s COVID-19 positive unit wearing a mask that did not cover her nose and without donning a gown, gloves, or eye protection, all required by CDC guidance at the time of the survey.  CMS Ex. 1 at 4; CMS Ex. 4 at 2.

Petitioner asserts CMS has not established a prima facie case of noncompliance because CDC guidance did not require transmission-based precautions (use of gowns, gloves, or eye protection) to care for Resident 1 at the time of the survey.  P. Closing Br. at 3, 14, 19-24.  Petitioner otherwise contends that even if LPN 1 wore her mask improperly while treating Resident 1, she conformed to Petitioner’s policy and prevailing national standards by waiting to adjust her mask until she finished providing care to Resident 1 so she could first wash her hands.  Id. at 17.  Petitioner finally argues CMS cannot establish a deficiency because Resident 1 could not have infected others with COVID-19 based on the total days elapsed since her infection and her asymptomatic presentation.  Id. at 15‑19, 24.

Petitioner’s arguments are without merit.  A facility that fails to follow national standards specified in its own policy is not in substantial compliance with its obligation to implement and maintain an adequate infection control program.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 13.  Here, the record establishes LPN 1 failed to comply with Petitioner’s policy by failing to correctly wear her mask and failing to don other appropriate PPE deemed necessary by the CDC to provide care to Resident 1.

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Petitioner diagnosed Resident 1 with COVID-19 and as a result housed her in the facility’s COVID-19 positive unit, where she resided at the time of the survey.  CMS Ex. 1; P. Ex. 3 at 8-9.  Petitioner’s infection control policy required its staff to wear a face mask while in the facility and employ Standard and Transmission-Based contact droplet precautions to care for residents known or suspected to have a COVID-19 infection.  CMS Ex. 5 at 34, 40.  It stated the facility would rely on CDC guidance to determine the appropriate level of PPE staff to employ when in close contact with residents.  Id. at 34, 41.  CDC recommendations at that time advised health care workers to don gloves, gowns, and eye protection to treat a patient with a confirmed COVID-19 infection.  CMS Ex. 8 at 19-20 (April 2020 CDC guidance advising the use of a facemask, gown, gloves, and eye protection for patients with a suspected or confirmed COVID-19 infection); CMS Ex. 10 at 5 (same).

Despite these provisions, state surveyors observed LPN 1 care for Resident 1 while improperly wearing a face mask in one instance9 and twice without wearing a gown, gloves, or eye protection as required by the CDC guidelines adopted by the facility.  CMS Ex. 1 at 4; CMS Ex. 4 at 2; CMS Ex. 5 at 34, 41; CMS Ex. 8 at 19-20; CMS Ex. 10 at 5.

Petitioner nevertheless asserts that LPN 1 had no obligation to wear a gown, gloves, or eye protection because Resident 1 met the CDC’s criteria for discontinuation of Transmission-Based Precautions.  P. Br. at 14-15; P. Closing Br. at 7; P. Ex. 5.  The facility points out that the CDC permitted facilities to discontinue Transmission-Based Precautions for patients confirmed by test as positive for COVID-19 infection if either they were asymptomatic and at least 10 days10 had passed since the first appearance of symptoms or if that patient received two negative COVID-19 tests 24 hours apart.  P. Closing Br. at 10-14.  Because the surveyors’ observations occurred when Resident 1 was asymptomatic and approximately 20 days after the test confirming her diagnosis, Petitioner contends a deficiency finding cannot follow for the failure of a member of its staff to comply with precautionary measures that were not technically required.  Id. at 14.

Petitioner’s effort to apply the CDC’s guidelines for discontinuation of Transmission-Based Precautions ex post facto fails because Petitioner never actually discontinued those precautions for Resident 1.  Had it done so, it would have documented that determination in Resident 1’s chart and, more critically, transferred Resident 1 to its non-COVID unit;

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leaving a COVID-negative resident inside the COVID unit would undermine the point of cohorting residents based on their COVID-19 status in the first place.

Failing to document the decision to discontinue Transmission-based precautions for Resident 1 or move her out of the COVID-19 unit is not a mere formality.  Petitioner’s COVID-19 unit contained other COVID-19 positive residents, P. Ex. 8 at 2, and its own administrator acknowledged that the facility deemed “residents on that unit still positive.”  Tr. at 23.  The fact that Resident 1 may or may not have been COVID-19 positive is irrelevant because LPN 1 treated her within the confines of the facility’s COVID-19 unit.  Under facility policy, LPN 1 was obligated to assume every resident inside the unit to be COVID-19 positive.11  Moreover, the CDC recommended health care workers use all recommended PPE to care for “all residents on affected units” even if asymptomatic.  CMS Ex. 8 at 28.  LPN 1’s failure to don the PPE recommended by the CDC therefore remains a violation of facility policy and prevailing national standards in effect at the time of the survey.12

Petitioner also contends LPN 1’s failure to don proper PPE does not amount to a deficiency because CMS has not established she was in “close contact” with Resident 1.  P. Br. at 15; P. Closing Br. at 18.  This claim is unpersuasive.  Petitioner’s policy does not define close contact aside from specifying appropriate social distancing to be greater than six feet.13  CMS Ex. 5 at 34.  Absent definition in Petitioner’s infection control

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policy or citation to relevant CDC guidance in effect at the time of the survey, I give the phrase “close contact” its ordinary meaning.  Sonjay Fonn, D.O. and Midwest Neurosurgeons, LLC, DAB No. 3086 at 13 (2023) (citation omitted) (affirming application of the “common and ordinary meaning” of a term undefined by the regulations).  Kneeling in front of a resident long enough to change bandages constitutes “close contact” as that term would ordinarily be understood.  As the CDC unequivocally observed in 2020, “[h]ealthcare delivery requires close physical contact between patients and [health care providers].”  CMS Ex. 13 at 4.

Even if I accepted Petitioner’s questionable claim that its staff did not have to don appropriate PPE under contact droplet precautions to enter its COVID-19 unit so long as staff did not expose themselves to residents for more than 15 minutes cumulatively in a 24-hour period, that claim does not apply to the obligation to wear a facemask.  Petitioner’s policy demanded all staff to “wear a mask while in the facility” regardless of proximity or time exposed to COVID-19 positive residents.  CMS Ex. 5 at 4, 41.  The CDC recognized the significance of universal masking for health care providers as a critical part of reducing the risk of community transmission for a disease for which fever and symptom screening proved relatively ineffective.  CMS Ex. 10 at 3-4.  Neither CDC guidance nor Petitioner’s infection control policy contemplate relaxing the obligation of health care providers to always wear a mask inside a facility, aside from limited circumstances to allow staff to eat and drink while observing social distancing protocols.

Petitioner does not dispute LPN 1 did not properly wear a face mask while treating Resident 1.  P. Ex 7 at 3 (acknowledging LPN 1 wore a mask that “must have slipped below her nostrils while providing care to Resident No. 1’s feet”).  Its only defense is that LPN 1 appropriately waited to adjust her mask until she had finished providing care to Resident 1 and could wash her hands.  P. Br. at 14; P. Closing Br. at 17; P. Ex. 11 at 1-2 (Estee Decl. ¶ 3) (citing CMS Ex. 5).  But Petitioner’s infection control policy does not allow staff to delay properly adjusting improperly fitted PPE while treating a resident or until it becomes convenient to wash hands.  CMS Ex. 5.

Such an exception to universal masking would profoundly undermine the goal of source control and prevention of community transmission of COVID-19, since incorrectly wearing a mask for a prolonged period would increase the likelihood of exposure.  CMS Ex. 5 at 36-41; CMS Ex. 10 at 2.  There may be a scenario where a member of staff would be involved in providing care so critical and emergent that the immediate risk to resident health in delaying treatment would outweigh the need to adjust an improperly fitted mask.  This is not that scenario.  When the surveyors observed LPN 1 wearing a mask below her nose, she was providing routine, non-emergent care to Resident 1, namely applying pressure wraps to her legs.  CMS Ex. 4 at 1; Tr. at 70.  Petitioner does not assert LPN 1 did not have close access to either a handwashing station or hand sanitizer that would have allowed her to briefly cease caring for Resident 1 so she could clean or sanitize her hands and then adjust her mask.  Indeed, its policy indicated the

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ready availability of soap and paper towels for handwashing or sanitizer inside residents’ rooms or outside them.  CMS Ex. 5 at 38.  Petitioner cannot justify LPN 1’s decision to leave her nostrils uncovered while providing routine care to a resident inside the facility’s COVID-19 unit.

Petitioner finally argues that CMS cannot establish a deficiency because LPN’s errors did not create the potential for more than minimal harm as Resident 1 could no longer transmit the COVID-19 virus.  P. Closing Br. at 15-19, 24.  Petitioner claims that the CDC’s guidelines for discontinuing Transmission-Based Precautions establish Resident 1 posed no risk of exposure as she was asymptomatic and approximately 20 days had passed from the date of her positive COVID-19 test, making her “non-infectious and non-contagious” at the time of the survey.  P. Closing Br. at 19, 24; P. Ex. 2 at 2 (CDC guidance providing facilities could discontinue Transmission-Based Precautions without need for testing if a patient who had tested positive for COVID-19 was asymptomatic and at least 10 days had elapsed since their positive COVID-19 test).

Petitioner’s claim erroneously relies on the assumption that the CDC’s discontinuation guidelines conclusively establish a resident who met the discontinuation criteria is not infectious or contagious.  In fact, the CDC recognized that the resolution of symptoms in individuals who tested positive for COVID-19 did not necessarily establish they were not contagious.  P. Ex. 1 at 3 (“While viral RNA shedding declines with resolution of symptoms, it may continue for days to weeks.”); P. Ex. 2 at 2 (“[B]ecause symptoms cannot be used to gauge where these individuals are in the course of their illness, it is possible that the duration of viral shedding could be longer than 10 days after their first positive test.”).

Furthermore, Petitioner limits its consideration to whether Resident 1 could still infect others more than 10 days following her positive COVID-19 test but fails to recognize the risk of reinfection to Resident 1 herself by leaving her in the COVID-19 unit.  The CDC emphasized that “[c]linical infection has been correlated with the detection of . . . antibodies.  However, definitive data is lacking, and it remains uncertain whether individuals with antibodies are protected against reinfection with SARS-CoV-2, and if so, what concentration of antibodies is needed to confer protection.”  P. Ex. 1 at 3.

In short, the CDC’s guidelines undermine Petitioner’s contention that meeting the criteria for discontinuation of Transmission-Based Precautions eliminated the possibility that Resident 1 was still infected, contagious, or subject to reinfection.  Petitioner did not confirm Resident 1’s negative COVID-19 status by retesting her.  Her lack of symptoms and the time elapsed after her last positive test were not sufficient to establish Resident 1 was not contagious or subject to reinfection.

LPN 1’s failure to properly wear her mask and wear all recommended PPE when providing care to Resident 1 therefore posed a risk of more than minimal harm.  If

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Resident 1 were still infectious, LPN 1 could have been infected and then transmitted the virus to COVID-19 negative residents, since staff members crossed between the COVID-19 and non-COVID-19 units due to staffing shortages.  CMS Ex. 4 at 1-2; P. Ex. 1 at 3.  In that case LPN 1 could have also subjected recovering residents in the COVID-19 unit to the risk of reinfection or transmitted the virus to another staff member who could later transmit it to a resident, other staff members, or their own families.  LPN 1’s failure to don appropriate PPE and correctly wear a mask while providing care to Resident 1 posed at least a potential for more than minimal harm.

7. CMS’s immediate jeopardy determination is unreviewable.

CMS determined Petitioner’s noncompliance with 42 C.F.R. § 483.80(a)(1), (2), (4), (e), and (f) resulted in a deficiency at scope and severity level “J,” meaning an isolated instance of noncompliance that poses immediate jeopardy to resident health and safety.  CMS Ex. 1; CMS Ex. 2 at 1.  CMS argues its determination of the scope and severity level and finding of immediate jeopardy are unreviewable because a successful challenge by Petitioner would not result in selection of a lower CMP range or restore a nurse aide training program the facility did not possess.  CMS Closing Br. at 23-24.  Petitioner contends it can challenge the level of noncompliance selected by CMS because “if the deficiencies at issue were cited at scope and severity level ‘D’ or lower . . . CMS would be without basis to assess a CMP.”  P. Closing Br. at 20.  In other words, Petitioner argues there is a lower penalty range – zero – that CMS could have chosen.

Petitioner’s argument is without merit.  A facility may challenge CMS’s determination of the scope and severity of noncompliance only if a successful challenge would affect the range of the CMP that may be imposed or would impact the facility’s authority to conduct a nurse aide training program.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  Neither of these circumstances is present here.  Petitioner did not have a nurse aide training program when CMS issued its notice of noncompliance.  Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2378 at 24 (2011); CMS Ex. 2; CMS Ex. 3 at 15.  And while Petitioner has perhaps creatively described scope and severity levels lower than ‘D’ as capable of yielding a lower penalty range, noncompliance at those levels is in fact described by another term – substantial compliance.  SOM Rev. 185 Ch. 7 § 7400.3.1.  In other words, changing the scope and severity level to ‘D’ or lower does not result in a different penalty range.  It obviates the basis for CMS to impose a penalty at all.

Therefore, a successful challenge would not affect the range of the CMP because CMS selected a per-instance CMP for which the regulations provide only a single penalty range without regard to the level of noncompliance.  42 C.F.R. § 488.438(a)(2).  There is no lower penalty range.  Pearsall Nursing & Rehab. Ctr. – N., DAB No. 2692 at 10 (2016) (“The Board has long held that because a per instance CMP has a single range, a successful challenge to a per-instance CMP could not affect the range of the CMP.”).

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Accordingly, CMS’s imposition of a per-instance CMP in this case makes its determination of scope and severity unreviewable.

8. The per‑instance CMP imposed by CMS is reasonable.

CMS is authorized to impose enforcement remedies against a facility that is not in substantial compliance with participation requirements.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  Among other enforcement remedies, CMS may impose a per-instance CMP for each instance of noncompliance.  42 C.F.R. § 488.430(a).  At the time CMS imposed remedies in this case, a per-instance CMP could range from $2,233 to $22,320.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (2020); see 85 Fed. Reg. 2869, 2886 (Jan. 17, 2020).

In determining the reasonableness of the penalty amount imposed, I look to the factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of the deficiency, the facility’s compliance history, its financial condition, and its degree of culpability.  42 C.F.R. § 488.438(f).  The absence of culpability is not a mitigating factor.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, I must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).  The Board has held that the CMP amount selected by CMS is presumptively reasonable based on the regulatory factors listed above, and that the burden is on the SNF “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction [in the penalty amount] is necessary to make the CMP amount reasonable.”  Crawford Healthcare & Rehab., DAB No. 2738 at 19 (2016).

Petitioner does not argue any regulatory factor supports a reduction of the CMP amount proposed by CMS, preferring to insist it remained in substantial compliance with Medicare participation requirements.  P. Closing. Br. at 15, 24.  For that reason alone, I could conclude the CMP amount is reasonable.  See Coquina Ctr., DAB No. 1860 at 32.  I have nevertheless reviewed the regulatory factors and find the CMP amount selected by CMS to be reasonable.

First, the seriousness of the deficiency is significant.  A member of Petitioner’s staff failed to use PPE as required by its infection control policy and as recommended by the CDC.  The CDC issued this guidance at the outset of the COVID-19 pandemic to prevent the spread of a novel disease among the elderly and infirm residents of nursing homes, a uniquely vulnerable population.  Before the advent of effective treatments or vaccination, implantation of effective infection control by facilities was the only line of defense available to these residents.  The potential consequences of failing to comply with these guidelines cannot be understated.

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Turning to culpability, I recognize that in 2020, nursing facilities were under enormous strain to provide adequate staffing and procure sufficient PPE in the face of a swiftly moving pandemic of unknown severity.  But that risk should have heightened Petitioner’s resolve to ensure its staff followed basic infection control protocols like wearing facemasks that covered their noses while caring for residents inside the COVID-positive unit.  Here, even though accompanied by the facility’s Director of Nursing, the surveyors are the ones who noticed LPN 1 did not use necessary PPE or wear her facemask correctly on two occasions 15 minutes apart.  CMS Ex. 1 at 4; CMS Ex. 4 at 1.  Petitioner is highly culpable because it failed to implement its own infection control policy by ensuring its staff properly used recommended PPE while treating its residents housed in the unit it created to isolate those with confirmed cases of COVID-19.

With respect to the facility’s history of noncompliance, the Certification Performance History submitted by CMS reveals numerous instances of noncompliance by Petitioner prior to the survey at issue.  CMS Ex. 3.  In the previous surveys, Petitioner had been cited for deficiencies at a “D,” “E,” “F,” and “G” scope/severity levels, including one related to infection control.  Id.  These prior instances of noncompliance do not support lowering the CMP amount.

Finally, there is no evidence in the record before me pertaining to Petitioner’s financial condition and thus no basis under that factor for me to consider lowering the CMP amount.

Although the $22,320 per-instance CMP amount imposed by CMS is the highest amount permitted within the per-instance CMP range for the year in question, my consideration of the foregoing factors leads me to conclude the imposition of a $22,320 per-instance CMP is reasonable.

VII. Conclusion

Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f).  CMS’s determination of the level of scope and severity of noncompliance is unreviewable.  I find imposition of a $22,320 per-instance CMP to be reasonable.