Wayne Health Care, DAB, CR6895 (2026)

DECISION

Following a complaint and recertification survey conducted by the New York State Department of Health from May 17, 2022, to May 23, 2022, the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner, Wayne Health Care, was not in substantial compliance with Medicare participation requirements.  CMS imposed a per-day civil money penalty (CMP) of $10,200 for one-day of immediate jeopardy on May 19, 2022, and a $245 per-day CMP from May 20, 2022, through July 21, 2022, for a total of $25,635.  For the reasons set forth below, I find that Petitioner was not in substantial compliance with Medicare requirements, and that the CMP is reasonable. 

I. Background and Procedural History

On January 28, 2022, the New York State Department of Health (state agency) received a self-reported complaint from Petitioner’s Director of Nursing (DON) that a resident (R150) had burned himself while smoking cigarettes.  Joint Statement of Undisputed Facts (Jt. Stmt.) at 1.  On April 6, 2022, Petitioner reported a second incident to the state agency again involving the same resident burning himself while smoking.  Id.  

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From May 17, 2022 to May 23, 2022, the state agency conducted a complaint and recertification survey of Petitioner’s facility.  Id.  Based on the surveys, the state agency, in a letter dated June 1, 2022, notified Petitioner that it had identified deficiencies with the Medicare requirement at 42 C.F.R. § 483.25(d) (Tag F689), Scope and Severity level J.1  CMS Ex. 22 at 1-2.  

As a result of these findings of noncompliance, CMS issued notice on August 23, 2022, that it was imposing a federal civil money penalty of $10,200 per day for one day on May 19, 2022, and a per-day CMP of $245 beginning May 20, 2022, and continuing through July 21, 2022.  CMS Ex. 2 at 1.  

On August 19, 2022, Petitioner filed a request for hearing.  On August 22, 2022, Administrative Law Judge (ALJ) Jacinta Alves issued an Acknowledgment Letter and her Standing Prehearing Order (SPO).  CMS then filed its prehearing exchange on November 18, 2022, which included a prehearing brief (CMS Br.) along with twenty-nine exhibits (CMS Exs. 1-29), and one proposed witness.  On January 13, 2023, Petitioner filed its pre-hearing brief (P. Br.) along with a list of four proposed witnesses.  Petitioner did not file any exhibits.  On January 23, 2023, CMS filed its reply brief (CMS R. Br.).  

On February 10, 2023, the parties filed a joint statement of issues, joint statement of undisputed facts, and a joint settlement status report in which the parties requested an oral hearing.  On September 3, 2024, ALJ Alves issued an order scheduling a hearing and admitted all of CMS’s exhibits.  On December 2, 2024, the parties filed requests to waive an oral hearing.  ALJ Alves granted the requests and cancelled the hearing.  

This case was subsequently transferred to me on December 29, 2025.  In an order dated January 12, 2026, I advised the parties that the case was ripe for a decision on the written record and requested that the parties submit a joint settlement status report prior to my issuing a decision.  On February 23, 2026, the parties submitted a status report advising that a settlement was not reached.  

II. Issues

The issues in this case are: 

• 1) Whether Petitioner failed to be in substantial compliance with the Medicare program participation requirements at 42 C.F.R. § 483.25(d)(1)-(2);
• 2) If the facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2) whether CMS’s determination that the noncompliance immediately jeopardized the health and safety of the facility’s residents was clearly erroneous; and
• 3) If Petitioner was not in substantial compliance, whether the amount of the CMP imposed on Petitioner is reasonable under the factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f). 

III.  Jurisdiction

I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 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). 

IV. Discussion

1. A. Applicable Legal Authority

The Act sets requirements for skilled nursing facilities (SNF) to participate in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819; 42 U.S.C. § 1395i-3.  The Secretary’s regulations are found at 42 C.F.R. pts. 483 and 488. 

To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’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.  “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 the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months and more often if necessary to ensure that identified deficiencies are corrected. 

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Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4) (42 U.S.C. § 1395i-3(g)(4)). 

The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.  Among other remedies, CMS is authorized to impose a per-day CMP for the number of days a facility is not in substantial compliance or a per-instance CMP for each instance of the facility’s noncompliance.  42 C.F.R. § 488.430(a).  In this case, CMS imposed a per-day CMP.  The regulations specify that a per-day CMP will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range, $7,317 to $23,989 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents, and, in some circumstances, for repeated deficiencies.2  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2022).  The lower range, $120 to $7,195 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table). 

Petitioner was also notified that it would be ineligible to conduct a Nurse Aide Training and Competency Evaluation Program (NATCEP).  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or nursing facility that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $11,995 (45 C.F.R. § 102.3 (Table) (2022)); or (3) subject to termination of its participation agreement, a denial of payment for new admissions (DPNA), or the appointment of temporary management.  Ineligibility or withdrawal of approval to conduct a NATCEP is mandatory if the conditions are satisfied.  See 42 C.F.R. § 488.406.  

If CMS imposes a remedy based on a noncompliance determination, such as a CMP, then the facility 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.  Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (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 or the factors CMS considered in selecting remedies.  42 C.F.R. § 488.408(g)(2). 

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A facility may only challenge CMS’s determination as to the scope and severity of noncompliance if a successful challenge would affect the range of the CMP that may be imposed, or impact the facility’s authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Board has held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to the parameters set forth in 42 C.F.R. § 488.438(e). 

1. B. Findings of Fact, Conclusions of Law, and Analysis
   1. 1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) (1)-(2) (Tag F689), because Petitioner failed to ensure Resident 150 received adequate supervision and assistance devices to prevent accidents.3

Petitioner was cited for not substantially complying with 42 C.F.R. § 483.25(d).  Under section 483.25(d), facilities must ensure, based on a resident’s comprehensive assessment, that: 

• (1) The resident environment remains as free of accident hazards as is possible; and
• (2) Each resident receives adequate supervision and assistance devices to prevent accidents. 

42 C.F.R. § 483.25(d). 

The facility must therefore eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.”  Del Rosa Villa, DAB No. 2458 at 7 (2012); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 9-10, aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 Fr. App’x. 900 (6th Cir. 2005); accord, Briarwood Nursing Ctr., DAB No. 2115 at 5 (2007) (holding that the facility must “take all reasonable steps to ensure that a resident receives supervision and assistive devices 

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designed to meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”). 

A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances.  Briarwood at 5; Windsor Health Care Ctr., DAB No. 1902, at 5 (2003), aff’d, Windsor Health Care Ctr. v. Leavitt, No. 04-3018 (6th Cir. 2005); 42 C.F.R. § 483.25(d).4  The issue is not whether the facility took “some steps” to mitigate an assessed risk; the issue is whether the facility took “all reasonable steps.”  Logan Healthcare Leasing LLC d/b/a Logan Care and Rehab, DAB No. 3036 at 15 (2021)  

2. 2. Background
   1. a. Resident 150

R150 was admitted to Petitioner’s facility on March 17, 2021, with diagnoses including diabetes and end stage renal disease with hemodialysis.  Jt. Stmt. at 3; CMS Ex. 10 at 1, 5, 14.  R150 utilized a motorized wheelchair and had “impaired physical mobility . . . [due to a] non-weight bearing left leg.”  CMS Ex. 11 at 1.  The Minimum Data Set (MDS) Assessment, dated May 6, 2022, showed R150’s Brief Interview for Mental Status (BIMS) score was a 15 out of 15, which indicated he was cognitively intact.  CMS Ex. 14 at 6. 

R150 was also a chronic smoker.  Jt. Stmt. at 3; CMS Ex. 1 at 3; CMS Ex. 8 at 1-14.  On March 18, 2021, R150 signed a “Smoking Policy Acknowledgement” which documented that he would follow the facility’s smoking policy or agree to transfer to another facility that allows smoking.  Jt. Stmt. at 4; CMS Ex. 1 at 3; CMS Ex. 12 at 1.  However, R150’s comprehensive care plan and Certified Nursing Assistant Care Card showed that he was noncompliant with the facility smoking policy.  Jt. Stmt. at 4; CMS Ex. 1 at 4; CMS Ex. 11 at 1-2, 11-12; CMS Ex. 13 at 1, 3.  The care plan also revealed that R150 was at risk for burns related to smoking and that staff should “encourage the use of burn blankets, fire-proof gloves, and cigarette holder.”  Jt. Stmt. at 4; CMS Ex. 1 at 4; CMS Ex. 11 at 3, 11-12; CMS Ex. 13 at 1, 3.  In addition, the care plan stated that the facility needed to respect “his right to decline [safety materials] although he is aware of risks such as burns and possibly death.”  CMS Ex. 11 at 11-12.  Further interventions included requiring the 

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resident to sign out at the nurses’ station when going to smoke and that smoking materials be kept in the medication room or in a locked drawer in his room.  Id.  

A nursing progress note and an Incident/Accident (“I/A”) Report, both dated January 27, 2022, documented that R150 reported three small brown circular burned areas on his right middle finger.  CMS Ex. 1 at 4; CMS Ex. 8 at 1-3, 6-7.  R150 had reported the burns were from his cigarette.  Id.  The I/A Report further indicated that staff would “[c]ontinue to encourage [R150] to use smoking alternatives [and] . . . [c]ontinue with current plan of care.”  CMS Ex. 8 at 3.  An Occupational Therapy (OT) referral was also ordered to evaluate the resident’s smoking ability.  CMS Ex. 1 at 4; CMS Ex. 8 at 1-3, 6-7. 

An OT evaluation dated February 1, 2022, documented that R150 had burned his hands and clothing while smoking due to difficulties with fine motor coordination needed to safely hold a cigarette.  CMS Ex. 1 at 4; CMS Ex. 9 at 1-3.  As such, R150 agreed to use a cigarette holder “to increase safety when smoking.”  Id.  Despite the intervention, OT treatment reports from February 1, 2022, to February 14, 2022, revealed that R150 had difficulties managing the cigarette holder, continued to forget to hold burning cigarettes away from his blanket and clothes, and brought cigarette butts into the facility on his lap blanket or in his pants pocket.  CMS Ex. 1 at 5; CMS Ex. 9 at 3-5.  The OT discharge note dated February 14, 2022, documented that R150 consistently used an ashtray in the wheelchair cup holder and no new burn marks were noted on the blanket or his gloves. CMS Ex. 1 at 5; CMS Ex. 9 at 5. 

Despite the incident and the care plan intervention, “Tobacco Screen and Safety” assessments dated January 27, 2022 and March 23, 2022, documented R150’s risk score as zero.  CMS Ex. 1 at 5; CMS Ex. 7 at 40.  Further, an OT note dated March 30, 2022, documented that a referral was again made by nursing staff due to R150’s decreased safety with smoking.  CMS Ex. 1 at 5; CMS Ex. 9 at 15.  The OT note, however, documented that “therapy not necessary at this time” because R150 had “demonstrated ability to smoke safely.”  Ex. 9 at 15.  

Nevertheless, on April 6, 2022, a nursing progress note and I/A Report documented a large hole in R150’s lap blanket.  Jt. Stmt. at 5; CMS Ex. 1 at 5; CMS Ex. 7 at 6; CMS Ex. 8 at 11-12.  R150 was observed with also three blisters on his right index finger and one blister on his right second finger.  Id.  R150 reported the blisters were burns from his cigarettes.  Id.  The resident stated:  “I get talking when I am smoking and my cigarettes do not burn out, so it will burn my finger when I’m not paying attention.”  Jt. Stmt. at 5; CMS Ex. 8 at 8, 12-13.  R150 was also re-offered a smoking apron and adaptive equipment, which was accepted.  Jt. Stmt. at 5; CMS Ex. 1 at 5; CMS Ex. 7 at 6; CMS Ex. 8 at 11-12.  Finally, the I/A Report documented that the facility would continue with R150’s current care plan and that no changes would be made.  Jt. Stmt. at 5; CMS Ex. 8 at 11-12.  On April 8, 2022, the facility updated the CNA Care Card to state that R150 

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should have a smoker’s blanket on when going outside to smoke.  Jt. Stmt. at 5; CMS Ex. 13 at 3.  

On April 18, 2022, Nurse Practitioner (“NP”) # 1 noted that R150 had new onset bilateral upper extremity unpredictable tremors, lethargy, and had missed a dialysis treatment.  Jt. Stmt. at 6; CMS Ex. 7 at 8.  NP # 1 also observed burns on his skin and recommend wound care.  CMS Ex. 7 at 8.  The treatment plan included cleansing the wounds, applying Silvadene cream, a non-stick dressing cover and wrapping with gauze, and oral antibiotics for 10 days.  Jt. Stmt. at 6; CMS Ex. 7 at 8-9.  NP # 1 also recommended transfer to the emergency room for evaluation for sepsis.  Jt. Stmt. at 6; CMS Ex. 1 at 6; CMS Ex. 7 at 8-9. 

On April 19, 2022, R150 was brought to the Emergency Department (“ED”).  CMS Ex. 7 at 10.  The ED treatment notes documented that R150 had significant stage 3 burns on his right hand secondary from smoking and cellulitis.  Id. at 12, 19.  The report further noted that R150 “appears to have chronic wounds, particularly in the left heel and between the fingers from cigarette burns.”  Id. at 19.  The physician also ruled out sepsis and recommended continuation of antibiotics and wound treatments.  Id at 19-20.  

In an OT daily treatment note dated April 19, 2022, it was documented that R150 stated he “has purposefully burned through fire retardant blanket to test its durability.”  CMS Ex. 9 at 17.  The OT also observed that R150 “demonstrates decreased safety awareness during smoking tasks” but did agree to wear fire retardant gloves.  Id.  However, in a note dated April 29, 2022, the OT documented seeing R150 smoking outside but “had gloves in pocket.”  CMS Ex. 9 at 18.  Further, R150 put the gloves on but said they were tight due to his bandages.  Id.  The OT thereafter cut the tips of the gloves to better fit.  Id.  

On May 2, 2022, OT notes reveal that R150 stated he was going to test the gloves to see if they burn.  Id. at 19.  The OT advised R150 that “he would be deemed not safe to smoke if he continues to purposely burn items.”  Id. at 19-20.  On May 3, 2022, the OT again documented R150 smoking without gloves.  Id.  The OT also documented the presence of scorch marks on two of his bandaged fingers.  Id.  The OT also documented that she informed the Nurse Manager that despite her efforts to encourage safety devices R150 would not comply.  Id. at 19. 

On May 5, 2022, the OT completed an observation of R150 smoking with a fire glove and had no burns.  Id.  However, after coming back to check on R150, the OT saw that the glove was melting and had two holes.  Id.  The OT documented that R150 should “go back [to] using previous industrial fire gloves therapist ordered.”  Id.  Finally, nursing notes between May 12, 2022, and May 17, 2022, indicated R150’s refusal to use a smoking blanket and documented additional wound care treatment for blisters on his fingers due to burns.  CMS Ex. 7 at 25-32.  

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1. b. Resident 152

R152 was roommates with R150.  Jt. Stmt. at 8; CMS Ex. 1 at 8; Ex. 15 at 1.  R152 was admitted to the facility on December 31, 2020, with diagnoses that included depression and osteoarthritis.  Jt. Stmt. at 8.  The MDS Assessment, dated May 6, 2022, showed the R152’s BIMS score was a 15 out of 15, indicating he was cognitively intact.  CMS Ex. 16 at 3, 6, 23.  

R152’s care plan and CNA Care Card documented that he was noncompliant with the facility smoking policy.  CMS Ex. 17 at 9-10, 15-16, 28-29.  The facility’s interventions for R152 included that he must wear a smoking blanket/apron and gloves, and use a bean bag ash tray while smoking.  Id.  He was also permitted to keep his own smoking materials in his room, so long as they were inaccessible to others.  Id. at 10.  Progress notes dated May 18-19, 2022 documented that R152 refused the burn resistant gloves and became upset when informed he must use a smoking blanket.  CMS Ex. 17 at 33-35.  On May 19, 2022, the state agency conducted an observation of the Petitioner’s facility.  CMS Ex. 1 at 9.  At that time, it was noted that R152 was smoking outside with a smoking blanket on his lap and with a bean bag ash tray across the blanket.  Id.  The ash tray was noted to have multiple cigarette butts and one with fresh ashes.  CMS Ex. 17 at 9-10, 15-16, 28-29.  R152 advised that surveyor that he was unable to extinguish the flames himself and that staff disposed of the ashes and butts in the garbage can in his room.  Id.  It was further observed that R152’s cigarettes were not locked in his room.  Id.  

1. c. Petitioner’s Policy

Petitioner’s policy, Smoke Free Work Environment, dated May 1, 2019 (the “Smoking Policy”), stated:  “[A]t some of our campuses, smoking is not permitted, or must be farther away than 15 feet” from the facility.  CMS Ex. 18 at 2.  “[C]urrent nursing home residents who smoke will be able to continue smoking in a designated area 30 feet from the building.  New residents must abide by our smokefree policy.”  Id.  

Notably, the policy did not require that residents be supervised while smoking.  See id.  Moreover, during the survey, the nursing staff advised that they do not watch the residents while they smoke.  CMS Ex. 29 at ¶ 63.  Allowing residents to smoke unsupervised was no small matter.  The smoking patio was outside the facility and approximately 60 feet from the building.  Id. at ¶ 73. 

1. d. Petitioner’s Noncompliance

Here, CMS has established its prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) because the evidence shows “the risk of harm posed by [R150] smoking was unquestionably foreseeable” and Petitioner further failed to provide supervision to prevent accidents to its residents from cigarettes.  See Logan 

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Healthcare Leasing, LLC d/b/a Logan Care & Rehab. (“Logan”), DAB No. 3036, at 7-8 (2021).  

With regard to Resident 150, CMS contends that facilities, such as Petitioner’s, that allow residents to smoke “must assess the residents’ capabilities and deficits to determine whether supervision is required [and] “ensure precautions are taken for the resident’s individual safety, as well as the safety of others in the facility.” CMS Br. at 15.  CMS further adds that pursuant to The National Fire Protection Association 101, Life Safety Code § 19.7.4 “[s]moking by patients classified as not responsible shall be prohibited,” except “where the patient is under direct supervision.”  Id. 

Petitioner disputes CMS’s claims and asserts that it provided R150 with “protective equipment to promote safe smoking practices.”  P. Br. at 7.  Petitioner further states that its “assistance devices were robust and complied with its requirements of 42 C.F.R. § 483.25(d)(2).”  Id.  Moreover, Petitioner states that R150 “acknowledged and understood that the devices were for the Resident’s protection and safety and for the safety of other residents.”  Id.  

At the outset, I note that there is no dispute that R150 was a chronic smoker and burned himself on at least two occasions.  Jt. Stmt. at 3.  The facility was also aware of the risks of accidents to R150 based on his smoking and his non-compliance with its policies.  Specifically, in a note dated March 18, 2021, it was documented that R150 had a “history of non-compliance with facility smoking policy” and had a “history of declining smoking blanket and gloves recommended by therapy.”  CMS Ex. 11 at 11.  Further, the “Smoking Policy Acknowledgement” documented that R150 would comply with the facility smoking policy or be transferred.  CMS  1 at 3; Ex. 12 at 1.  Nevertheless, R150 continued to be noncompliant with his smoking interventions and burned himself on multiple occasions.  CMS Ex. 1 at 2, 5; Ex. 8 at 1-14. 

Here, the facility anticipated the potential for accidents, but it did not take reasonable steps to ensure that R150 received adequate assistance devices and supervision to prevent accidents as required by 42 C.F.R. § 483.25(d)(2).  The facility’s smoking policy did not have any procedure for assessing the degree of supervision required for its smokers.  In fact, there is no indication that residents such as R150, who were authorized to smoke were supervised at all.  The lack of a systematic procedure allowed residents, such as R150, who had a history of noncompliance, to smoke without any monitoring.  This failure to provide any supervision ultimately resulted in allowing R150 to smoke and injure himself from burning cigarettes.  Whatever individual assessments the facility made for R150, allowing him to smoke but with gloves and a smoking jacket, involved no supervision and was not an adequate assistance device because he did not use them or use them properly. 

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Contrary to Petitioner’s arguments, the facility was not relieved of its duty to protect R150 simply because R150 was alert and competent.  The facility asserts that it “recognizes it is responsible for the well-being of its residents, but also recognizes the rights of cognitive residents to make decisions about their quality of life” when it allowed him to choose whether to smoke in his wheelchair.  P. Br. at 10.  Nonetheless, a resident’s right to make decisions ends where it conflicts with health or safety.  The Act provides that residents have the right to “receive services with reasonable accommodation of individual needs and preferences, except where the health or safety of the individual or other residents would be endangered . . . ”  Act, § 1919(c)(1)(A)(v)(I). 

The facility also claims it had no notice or reason to restrict the “basic human right” of R150.  P. Br. at 8.  However, while R150 was generally alert and oriented, the record reflects that R150 had numerous health concerns placing him at a foreseeable risk of injury and, further, that he had a history of noncompliance with the facility’s smoking care plan.  See CMS Ex. 1 at 6; Ex. 7 at 8-9; Ex. 9 at 17, 19-20.  Specifically, the record reflects that R150 would fall asleep while smoking and had tremors and shaking.  CMS Ex. 1 at 4-6.  R150 also admitted that he would “get talking” and his “cigarettes do not burn out, so it will burn [his] finger when [he’s] not paying attention.”  CMS Ex. 1 at 5; Ex. 7 at 6.  Further, Petitioner’s own records show R150 accidentally and intentionally burning his clothing, gloves, and blanket.  CMS Ex. 1 at 6; Ex. 7 at 8-9; Ex. 9 at 17, 19-20.  

Thus, while facilities are allowed flexibility in choosing methods to prevent accidents, the methods must constitute an adequate level of supervision and assistance devices.  42 C.F.R. § 483.25(d)(2).  A smoking jacket and gloves are not supervision, and the facility’s care plan did not include supervising his smoking.  Moreover, given the facility’s knowledge of R150’s noncompliance with his care plan, these devices were not adequate supervision.  A facility's duty of care owed to its residents is not one of strict liability, but the facility must provide adequate supervision and assistance devices to prevent accidents.  Crestview Manor, CR1350 (2005); Windsor, DAB No. 1902, at 5.  Neither were present here. 

Therefore, I find that Petitioner failed to ensure that each resident received adequate supervision and assistance devices to prevent accidents pursuant to 42 C.F.R. § 483.25(d).5 

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1. C. Petitioner failed to prove that CMS’s immediate jeopardy determination was clearly erroneous.

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.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Barbourville Nursing Home, DAB No. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007). 

Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the facility to show that CMS’s determination is clearly erroneous.  Grace Healthcare of Benton, DAB No. 2189 at 13 (2008) (citing Liberty Commons Nursing & Rehab Ctr.-Johnston, DAB No. 2031 at 17-18 (2006), aff'd sub nom. Liberty Commons Nursing & Rehab Ctr. - Johnston v. Leavitt, 241 F. App'x 76 (4th Cir. 2007).  The harm or threatened harm is presumed to be serious, and the facility has the burden of establishing that the harm or threatened harm “did not meet any reasonable definition of ‘serious.”’ Maysville Nursing and Rehab., DAB No. 2874 at 21 (2018) (quoting Libertywood Nursing Ctr., DAB No. 2433 at 18 (2011), aff'd sub nom. Libertywood Nursing Ctr. v. Sebelius, 512 Fed. App’x 285 (4th Cir. 2013)). 

As discussed in detail above, the evidence in this case establishes that R150 burned himself on multiple occasions while smoking unsupervised, including one incident that resulted in his being treated in the emergency room.  Moreover, the facility anticipated the potential for accidents due to R150’s smoking and noncompliance with its policies 

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but failed to take reasonable steps to ensure that R150 received adequate assistance devices and supervision to prevent accidents as required by 42 C.F.R. § 483.25(d)(2). 

While Petitioner argues that the immediate jeopardy finding should be reversed, it has failed to make any substantive argument showing that the finding was clearly erroneous.  See generally P. Br.  Moreover, having reviewed the evidence, I conclude that the finding of immediate jeopardy must be sustained because it was not clearly erroneous.  The evidence shows that there was actual serious injury to R150, including multiple burns and treatment for cellulitis due to the burns.  Significantly, Petitioner does not dispute that R150 was not seriously harmed.  

As discussed above, Petitioner did not take all reasonable measures to provide adequate supervision and assistance devices to prevent accidents.  It failed to adequately ensure that its residents would not be harmed while smoking and even after it knew of smoking-related burns it failed to update R150’s care plan.  These failures placed R150 in a situation that caused serious harm.  Accordingly, I find that CMS did not clearly err in concluding Petitioner’s noncompliance with 42 C.F.R. § 483.25(d)(1)-(2) and 42 C.F.R. § 483.90(d)(2) posed immediate jeopardy to the health and safety of Resident 1. 

1. D. The penalties imposed are reasonable in amount and duration.

In determining whether the CMP amount is reasonable, I must apply the following factors which are listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance, including repeated deficiencies; 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).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).  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 choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 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), (3); Alexandria Place, DAB No. 2245 at 27; Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  The Board has explained 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).  The burden is on the facility to 

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demonstrate that a reduction is necessary to make the CMP amount reasonable.  Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017). 

In assessing the reasonableness of a CMP amount, an ALJ considers the per-day amount, rather than the total accrued CMP.  See Kenton, DAB No. 2186 at 28.  Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404.  See, e.g., Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 19-20 (2010).  Because I sustained the finding of noncompliance at the immediate jeopardy level, the penalty amount for the first day of the period of noncompliance must be from the higher range of penalties.  42 C.F.R. § 488.438(a)(1)(i).  For the year in question, that range is $7,317 to $23,989 per day.  45 C.F.R. § 102.3 (2022); 87 Fed. Reg. at 15,100, 15,112 (March 17, 2022).  The lower per-day CMP range of $120 to $7,195, as adjusted annually, is also applicable to this case, because this range applies to deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3.  

Here, CMS imposed a CMP of $10,020 for one-day of immediate jeopardy on May 19, 2022, and a $245 per-day CMP from May 20, 2022, through July 21, 2022, for a total of $25,635 which are reasonable.  The $10,020 amount, as well as the $245 amount, are at the lower end of the penalty ranges.  The evidence shows that CMS “considered [Petitioner’s] history, including any repeated deficiencies, its financial condition, and the factors specified in . . . 42 C.F.R. § 488.404.”  Id. 

Petitioner argues that the total amount of the CMP is unreasonable because the facts fail to demonstrate any noncompliance, that it did not demonstrate culpable conduct, and that it had no prior history with these cited violations.  P. Br. at 9-10.  However, I have determined that the facts before me support a finding of substantial noncompliance.  Thus, the issue before me is whether the regulatory factors were considered in setting the CMP amount and whether those factors support the CMP amount.  42 C.F.R. §§ 488.438(f), 488.404.  

Considering the factors, Petitioner’s noncompliance was very serious.  Petitioner’s failure to adequately supervise R150 resulted in a serious injury, for which Petitioner is culpable.  Petitioner’s culpability is also significant because it failed to update its care plan or provide supervision after it knew of R150’s injuries and/or noncompliance with his care plan.  Petitioner has not offered any argument or rebuttal to CMS’s evidence showing its history of noncompliance, nor has it made any argument that it cannot pay the per-day CMP.  I thus find no basis to reduce the CMP.  As a result, considering the regulatory factors here, I conclude that the CMP amounts imposed are reasonable. 

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V. Conclusion

For the reasons discussed above, I conclude that Petitioner was not in substantial compliance with the Medicare participation requirements at 42 C.F.R. § 483.25(d)(1)-(2).  A CMP of $10,200 for one-day of immediate jeopardy on May 19, 2022, and a $245 per-day CMP from May 20, 2022, through July 21, 2022, for a total of $25,635, is reasonable.  CMS is required by law to prohibit Petitioner from having a NATCEP for two years.