Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Medina Valley Health & Rehabilitation Center,
(CCN: 675974),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-22-516
Decision No. CR6891
DECISION
Resident 1 (R1), an elderly man with hypertension, extreme hearing loss, and cognitive deficits, was temporarily placed at Medina Valley Health & Rehabilitation Center (Petitioner), a skilled nursing facility, based on a court order. R1 had been living out of a car without access to running water and electricity, and a physician determined that he had uncontrolled hypertension and lacked the capacity to reject protective services.
After arriving at Petitioner’s facility, Petitioner instituted a care plan for R1, which included administering blood pressure medication, cognitive care, and the placement of a WanderGuard device on R1 to protect against an assessed moderate risk of elopement from the facility. Several days after admission, the Petitioner assessed R1 as severally cognitively impaired but physically independent in walking and transfers.
Within a few weeks of admission, government officials informed R1 that the court order had ended. One evening, shortly after R1 learned that he no longer was required to stay at Petitioner’s facility, Petitioner’s staff confirmed that R1’s WanderGuard was in place and then left him for the rest of the night without checking on him. In the morning, Petitioner’s staff realized R1 was absent and searched the facility and surrounding area.
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Two days later, R1 was found living under a bridge and was taken by ambulance to a hospital emergency room. During the intervening time, R1 did not have food or his medication. A physician at the hospital determined that R1 was in stable condition and discharged R1 to a homeless shelter.
Acting on behalf of the Centers for Medicare & Medicaid Services (CMS), the Texas Health and Human Services Commission (state agency) investigated the circumstances surrounding R1’s absence from Petitioner’s facility. The state agency found that Petitioner failed to substantially comply, at the immediate jeopardy level, with Medicare requirements to provide adequate supervision to prevent accidents. CMS imposed a remedial civil money penalty (CMP) on Petitioner. Petitioner requested a hearing to dispute the state agency’s findings of noncompliance and that such noncompliance immediately jeopardized residents.
For the reasons explained below, I conclude that: Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d); CMS’s determination that Petitioner immediately jeopardized the health and safety of residents is not clearly erroneous; and the amount of the remedial per-day CMP is appropriate and reasonable.
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 the age of 65 who meet other criteria. 42 U.S.C. § 1395c. Post-hospital care includes extended care services provided at a skilled nursing facility (facility). 42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).
For Medicare program purposes, a facility 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). If a facility wants to participate in the Medicare program, it must enroll in that program. 42 U.S.C. § 1395cc(j). Because a facility is a “provider of services” for Medicare program purposes, each facility participating 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).
A Medicare participating facility must meet a variety of ongoing statutory requirements as to how it provides services, maintains the rights of its residents, and administers its
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facility.1 42 U.S.C. § 1395i-3(a)(3), (b)-(d). Further, each facility 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.” 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 implement the statutory requirements and to establish those “other requirements relating to health, safety, and well-being of residents.” See 42 C.F.R. pt. 483, subpt. B.2
When a facility fails to meet a statutory or regulatory participation requirement, then the facility has a “deficiency.” 42 C.F.R. § 488.301; see also 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; see also 42 U.S.C. § 1395i-3(h)(3). To maintain “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.
“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
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use of public moneys.” 42 U.S.C. § 1395i-3(f)(1). To do so, the Secretary contracts with state agencies to survey participating facilities. 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 investigate complaints made against facilities. 42 U.S.C. § 1395i-3(g)(1)(C), (4).
When the results of a survey or investigation show that a facility is not in substantial compliance with Medicare program participation requirements, the Secretary may impose remedies on the facility, which include the following: denial of payment for Medicare beneficiaries admitted to the facility; denial of payment for new admissions to the facility; and termination of the facility’s Medicare provider agreement. 42 U.S.C. §§ 1395i-3(h), 1395cc(b); 42 C.F.R. § 488.406.
Another 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 facility’s noncompliance or a per‑day CMP for the number of days a facility 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 March 17, 2022, and for deficiencies that occurred after November 2, 2015, the CMP amounts range as follows: $2,400 to $23,989 for per-instance CMPs; $120 to $7,195 per day for less serious noncompliance; or $7,317 to $23,989 per day for noncompliance that poses immediate jeopardy to the health and safety of residents. 45 C.F.R. § 102.3 (2020); 87 Fed. Reg. 15100, 15111-12, 15119-20 (Mar. 17, 2022); see also 42 C.F.R. § 488.438(a) (CMP ranges before statutory adjustments).
All remedies imposed on facilities are remedial in nature because they “ensure prompt compliance with [Medicare] program requirements” and “are applied on the basis of noncompliance found during surveys conducted by CMS or by the survey agency.”3 42 C.F.R. § 488.402(a)-(b); NMS Healthcare of Hagerstown, DAB No. 2603 at 8 n.6 (2014) (holding that, although the regulations use the term “civil money penalty,” the regulations also “make it clear that a CMP is not a punitive mechanism.”). To assist a facility in returning to substantial compliance quickly, facilities must file a plan of correction with the state agency/CMS. 42 C.F.R. § 488.402(d).
When CMS selects a remedy to impose on a facility, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm
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or potential harm) for each deficiency. See 42 C.F.R. § 488.404(a)-(b). The highest level of severity occurs when the noncompliance immediately jeopardizes the health or safety of facility residents. See 42 U.S.C. § 1395i-3(h)(1)(A). “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.
A facility may request a hearing before an administrative law judge to dispute the finding of noncompliance leading to the imposition of an enforcement remedy. 42 U.S.C. §§ 405(b), 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii), 1395cc(h)(1); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.402(f)(1)(iv), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(8), (13), 498.40; see Shalala v. Ill. Council on Long Term Care, Inc., 529 U.S. 1, 21 (2000) (holding that facilities are entitled to review of any determination of substantial noncompliance with Medicare participation requirements whether termination or “some other remedy is imposed.”); 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).
When challenging the imposition of a CMP, a facility may also challenge the level of noncompliance if: 1) a successful challenge would affect the range of CMP amounts imposed on the facility; or 2) a finding of substandard quality of care results in the loss of approval of a nurse aide training program. 42 C.F.R. § 498.3(b)(14), (d)(10). If a facility challenges CMS’s determination as to the level of noncompliance, then the facility must show that CMS’s determination was clearly erroneous. 42 C.F.R. § 498.60(c)(2).
A facility may also dispute the amount of the CMP. The review of the CMP amount is limited to considering the statutory and regulatory factors for setting the CMP amount. 42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f). A CMP may not be reduced to zero. 42 C.F.R. § 488.438(e)(1).
When a facility challenges CMS’s determination that there was a deficiency, CMS must make a prima facie case that the facility failed to substantially comply with Medicare participation requirements and, if such a showing is made, the facility must then prove substantial compliance by a preponderance of the evidence. Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997),aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Hum. Servs., No. Civ.A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); 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).
Either party may request Departmental Appeals Board (DAB) review of an administrative law judge’s decision. 42 C.F.R. § 498.80; see also 5 U.S.C. § 557.
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II. Background
Petitioner is a facility located in Castroville, Texas. On February 25, 2022, facility staff informed the state agency that R1 was missing from the facility. CMS Ex. 5 at 1-2. On February 28, 2022, the state agency completed an “incident investigation” at Petitioner’s facility. CMS Ex. 2 at 1. The state agency found that Petitioner was noncompliant with 42 C.F.R. § 483.25(d) and that the noncompliance immediately jeopardized the health and safety of residents. CMS Ex. 2. On March 15, 2022, the state agency informed Petitioner that it lost its approval for a Nurse Aide Training and Competency Evaluation Program (NATCEP) because Petitioner’s noncompliance constituted substandard quality of care. Electronic Filing System (E-File) Doc. No. 1b at 2. On April 7, 2022, CMS imposed a $10,780 per-instance CMP on Petitioner. CMS Ex. 1 at 1.
On May 11, 2022, Petitioner requested a hearing to dispute the findings of noncompliance, the finding of immediate jeopardy, and the amount of the CMP. Also on May 11, 2022, the Civil Remedies Division acknowledged the hearing request and issued my Standing Prehearing Order.
On August 9, 2022, CMS filed a prehearing exchange that included six proposed exhibits, one of which was the written direct testimony for a witness (CMS Ex. 6). On September 13, 2022, Petitioner submitted a prehearing exchange that included four proposed exhibits, two of which were written direct testimony from witnesses (P. Exs. 1, 3). CMS and Petitioner filed objections to some of the proposed exhibits. Petitioner requested to cross-examine CMS’s witness. CMS waived cross-examination of Petitioner’s witnesses.
On December 9, 2022, I notified the parties that I would hold a hearing on May 19, 2023. In the Notice of Hearing, I admitted the proposed exhibits, except for the second page of Petitioner Exhibits 1 and 3, which contained a written statement from an individual that was not in the form of an affidavit or a declaration made under penalty of perjury. On January 10, 2023, Petitioner corrected the written statement so that it could serve as written direct testimony for a third witness (P. Ex. 5). Petitioner also requested that I add another issue to be decided in this case. CMS did not object to Petitioner Exhibit 5 or Petitioner’s request that I formally add another issue to be decided in this case. CMS also did not request to cross-examine the person who signed Petitioner Exhibit 5. On February 3, 2023, I amended the Notice of Hearing to add the third issue requested by Petitioner and admitted Petitioner Exhibit 5 into the record.
On May 19, 2023, I held a hearing at which Petitioner cross-examined CMS’s witness. At the end of the hearing, I discussed the schedule for post-hearing briefing and the requirement that the parties present, in their post-hearing briefs, all of their arguments without cross-referencing earlier briefs. Tr. 37; see June 15, 2023 Notice of Receipt of Transcript and Post-Hearing Briefing Schedule at 2.
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CMS filed a post-hearing brief (CMS Br.) in July 2023, and Petitioner filed a post-hearing brief (P. Br.) in September 2023.
III. Issues
1) Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25(d).
2) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d), whether CMS’s determination that Petitioner immediately jeopardized the health and safety of its residents is clearly erroneous.
3) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d), whether a $10,780 per-instance CMP is reasonable under the statutory and regulatory factors for setting a penalty amount.
IV. Findings of Fact, Conclusions of Law, and Analysis
My findings of fact and conclusions of law are in bold and italics.
1. Resident 1 (R1), a man in his early 80’s, was living in his car on property owned by a friend. R1 did not have access to running water or electricity on the property, and R1 periodically had no food. After learning of R1’s situation, Adult Protective Services (APS) investigated the situation and sought to help R1. A medical examination resulted in a diagnosis of hypertension and hyperlipidemia. The physician’s assessment also included the conclusion that, at the time, R1 lacked the capacity to consent or reject protective services. In early January 2022, APS sought and obtained an emergency court order directing APS to place R1 in an appropriate medical facility. APS placed R1 in a nursing home, where a physician prescribed Amlodipine for his hypertension. On January 21, 2022, the court extended the emergency order for 30 days.
On July 21, 2021, APS, a component of the Texas Department of Family and Protective Services, received a report that R1, an 81-year-old man, was living in his vehicle. APS’s investigation revealed that R1 had been living in his vehicle for about 5 months on land owned by his friends. R1 could not read or write, was a Spanish speaker, and read lips due to hearing loss. R1 stopped taking his medications for high cholesterol and blood pressure because it made him feel sick. R1 periodically went without food, and there was no running water or electricity on the property where R1’s vehicle was parked. CMS Ex. 4 at 1, 78-79; Tr. 21.
On January 10, 2022, APS petitioned the County Court for Atascosa, Texas (County Court) for an emergency order for protective services for R1. CMS Ex. 4 at 73-77. APS
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requested immediate removal of R1 from his residence to a medical facility for any necessary medical services to alleviate immediate threats to his life or physical safety and for the “[a]uthority to seek a temporary suitable placement if discharge occurs from the hospital before this order ends.” CMS Ex. 4 at 74.
In support of the petition, APS submitted an affidavit from an APS employee and a medical report from a physician. The APS employee detailed the investigation into R1’s situation and her efforts to assist R1 to obtain food stamps and housing. CMS Ex. 4 at 79. She also stated that R1 declined to go to a homeless shelter or a facility but agreed to go to a hospital for a medical evaluation. CMS Ex. 4 at 79.
A physician examined R1 on January 5, 2022, and, in his report, concluded that R1 had untreated hypertension and hyperlipidemia, and severe hearing impairments. CMS Ex. 4 at 82. The physician observed that R1 was unbathed, smelled of body order, and wore filthy clothing. CMS Ex. 4 at 82. The physician assessed R1’s memory and orientation as impaired, and the physician stated that R1 could not follow simple commands, had no insight, and had poor judgment. CMS Ex. 4 at 83. The physician concluded that R1 lacked capacity “[a]t this time” to consent or reject protective services. CMS Ex. 4 at 84.
On January 10, 2022, the County Court issued an Ex Parte Emergency Order and Order Setting Hearing on Motion to Extend Emergency Order for an Additional Thirty Days (Emergency Order). CMS Ex. 4 at 65-67, 70-71. The County Court found that there was reasonable cause to believe that abuse or neglect presented a threat to life or physical safety for R1 and that R1 lacked the capacity to “consent to services.” CMS Ex. 4 at 65, 70. As a result, the County Court ordered R1 removed from his residence or current location and be taken to an appropriate medical facility. CMS Ex. 4 at 65, 70. The County Court stated that, unless extended, the Emergency Order would expire ten days later. CMS Ex. 4 at 66, 71.
On January 10, 2022, R1 was admitted to Lytle Nursing Home. CMS Ex. 4 at 3-4. A physician at the nursing home ordered Amlodipine 10 mg for R1. CMS Ex. 4 at 44-45. R1
On January 21, 2022, the County Court extended the Emergency Order for an additional 30 days, noting that the order would expire on February 19, 2022. CMS Ex. 4 at 64, 69.
2. R1 was admitted to Petitioner’s facility on January 26, 2022, under the authority of the Emergency Order and under APS’s general supervision. R1’s admitting diagnoses included hypertension, dementia, mixed hyperlipidemia, and homelessness. R1 also tested positive for COVID-19. On January 26 and 27, 2022, Petitioner assessed R1 as a moderate risk for wandering and elopement, and Petitioner established a care plan for concerns related to falling, elopement, impaired cognitive function, and
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hypertension. A physician prescribed Amlodipine 10 mg and ordered the placement of a WanderGuard on R1. On February 3, 2022, Petitioner’s staff conducted a Brief Interview for Mental Status (BIMS), and R1 scored a 5, which means R1 had severe cognitive impairments. On February 4, 2022, Petitioner’s staff assessed R1’s mental status as unchanged but assessed Petitioner’s functional abilities as independent with walking, transfers, and toileting.
On January 26, 2022, Petitioner admitted R1 to its facility. CMS Ex. 4 at 1; Tr. 21. At the time, R1 was still under the general supervision of APS and the admission was based on the Emergency Order. CMS Ex. 4 at 1, 47-48; Tr. 17. R1’s admitting diagnoses were: unspecified dementia without behavioral disturbance; personal history of COVID-19; mixed hyperlipidemia; essential (primary) hypertension; and homelessness. CMS Ex. 4 at 1; Tr. 13. When Petitioner admitted R1, R1 tested positive for COVID-19 and was placed in isolation. CMS Ex. 4 at 6, 48-49; Tr. 13-14.
On January 26, 2022, Petitioner’s staff assessed R1 for wandering and elopement. Two assessments appear in the record with the same date and time, and both assessed R1 as a moderate risk. CMS Ex. 4 at 58, 62. However, one assessment recommended placement of a WanderGuard on R1 based on the following: R1 ambulates independently or with a device; R1 is highly confused; and R1 attempted to leave the facility one or more times.4 CMS Ex. 4 at 58-59. The other assessment differed in that it made no recommendation concerning the WanderGuard, and stated R1 was only mildly confused and had made no attempts to leave the facility. CMS Ex. 4 at 62-63.
On January 26-27, 2022, Petitioner established a care plan for R1. CMS Ex. 4 at 5-20. The care plan included the following entries:
- Moderate risk for falls (entered on January 26, 2022). CMS Ex. 4 at 16.
- Elopement risk/wanderer disoriented as to place with impaired safety awareness (entered on January 27, 2022). A goal was that R1 would not leave the facility unattended. Petitioner placed a WanderGuard device on R1 “to alert staff if resident attempts to exit facility unassisted d/t high risk for wandering.” CMS Ex. 4 at 10, 35.
- Impaired cognitive function/dementia or impaired thought process (entered on January 27, 2022). CMS Ex. 4 at 13, 36.
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- Activities of Daily Living (ADL) performance deficit (entered on January 27, 2022). CMS Ex. 4 at 9.
- Hypertension (entered on January 27, 2022). Petitioner required staff to provide R1 with hypertension medication as ordered, to take R1’s blood pressure before administering the medication, and to monitor R1 for signs and symptoms of malignant hypertension. CMS Ex. 4 at 12, 35-36.
On January 26-27, 2022, R1’s physician agreed with R1’s care plan, certified that R1 requires nursing care for 180 days, and ordered WanderGuard placed on R1 due to R1’s high risk for wandering. CMS Ex. 4 at 42-43.
On January 27, 2022, and February 3, 2022, Petitioner’s staff assessed R1 as having a BIMS score of 5, “indicative of severe cognitive impairments.”5 CMS Ex. 4 at 48, 55; Tr. 10.
A February 4, 2022 skilled nursing assessment found that R1 had no change in baseline cognitive function and was independent in all assessed matters for his “Functional Status,” including the following: walking ten feet, toilette transfer, chair/bed transfers, sit to stand, lying to sitting on the bed side, sitting to lying down, toilette hygiene, and oral hygiene. CMS Ex. 4 at 38-40. Further, for the “Interventions, Care, and Services” portion of the assessment, none of the listed interventions or services were checked. CMS Ex. 4 at 40-41.
On February 7, 2022, a physician assistant conducted a physical on R1 and indicated that R1 should continue to receive 10 mg of Amlodipine for his hypertension and that R1’s dementia was mild. CMS Ex. 4 at 51-52; P. Ex. 2 at 2.
3. On February 19, 2022, the Emergency Order expired and APS informed R1 of this. APS did not inform Petitioner. On February 24, 2022, at approximately 10:30 p.m., Petitioner’s staff confirmed that R1’s WanderGuard was placed on R1 and was functioning. Facility staff did not check on R1 throughout the night. At 6:45 a.m. on February 25, 2022, facility staff realized that R1 left the facility without informing Petitioner’s staff. Petitioner had not taken food or his medication with him. On
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February 27, 2022, R1 was found living under a bridge and was taken by ambulance to a hospital emergency room. A physician determined that R1 was in stable condition and discharged him to a homeless shelter after providing him with some food.
The Emergency Order expired on February 19, 2022, which meant that R1 was now his own responsible party and was no longer under APS’s oversight. Tr. 17-19. APS informed R1 that the Emergency Order expired but did not inform the facility. P. Ex. 1 at 1; P. Ex. 3 at 1.
On February 24, 2022, at the beginning of the 10:00 p.m. to 6:00 a.m. shift, Petitioner’s staff confirmed that the WanderGuard was placed on R1 and was functioning. CMS Ex. 4 at 24.
A February 25, 2022 Progress Note for R1, entered at 2:04 p.m., stated: “Resident not in facility.” CMS Ex. 4 at 50. Another Progress Note for R1, entered at 2:32 p.m., stated:
At approx 0645 this nurse entered the resident’s room and noticed the resident was not in room. The nurse immediately searched the bathroom and common areas. The nurse then informed other staff to expand the search of building to find the residents whereabouts. The nurse then notified the [Director of Nursing] of the situation and the staff began to search the surrounding areas.
CMS Ex. 4 at 50; see also CMS Ex. 5 at 3. The last time facility staff saw R1 was at approximately 10:30 p.m. on February 24, 2022, and staff had not checked on R1 throughout the rest of the overnight shift into February 25, 2022. CMS Ex. 6 ¶¶ 8-10; see also CMS Ex. 5 at 48.
On February 27, 2022, R1 was found and taken to a hospital by EMS. The “Initial Comments” in the Emergency Room Visit Notes state:
82-year-old male with unknown medical history but is coming from [Petitioner’s facility] after reportedly “escaped” from the facility on Thursday. Today he was found under a bridge. He is hard of hearing. EMS requesting a wellness check for the patient. His vital signs are normal. He has no pain complaints. He states he is very hungry because he has not eaten for the last few days but otherwise has no complaints. Appears well. Interactive.
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P. Ex. 4 at 1; see also CMS Ex. 6 ¶ 11. The Emergency Room physician determined that Petitioner’s vital signs were unremarkable and that he was stable. P. Ex. 4 at 2. The physician stated that the hospital would give R1 some food and return him to Petitioner’s facility. P. Ex. 4 at 2. However, R1 was discharged to a homeless shelter. CMS Ex. 6 ¶ 12; P. Ex. 1 at 1; P. Ex. 3 at 1. R1 was hungry and did not have his medications when he eloped. Tr. 23.
4. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) because Petitioner did not provide adequate supervision to ensure that a homeless, elderly man with dementia and hypertension diagnoses, who was assessed as a moderate elopement risk, did not leave the facility without an appropriate discharge, medications, and either housing or appropriate transportation to the previous location where he lived. Petitioner left on foot in the night, without food or medications, and was found living beneath a bridge when located two days later. Although Petitioner ensured that a WanderGuard was placed on R1 and was functioning prior to R1’s elopment, Petitioner’s staff did not check on R1 throughout the night, which was inadequate supervision.
The Social Security Act requires facility’s to “care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident” and “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.” 42 U.S.C. § 1395i-3(b)(1)(A), (2). To properly enforce the statute, the Secretary promulgated the “quality of care” regulation at 42 C.F.R. § 483.25, which requires facilities to ensure the following:
(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).6
Section 483.25(d)(1) requires facilities to address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of
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accident to the extent possible.” Maine Veterans’ Home - Scarborough, DAB No. 1975 at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)). The provisions of section 483.25(d) “come into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm.” Meridian Nursing Ctr., DAB No. 2265 at 9 (2009), aff’d sub. nom. Fal‑Meridian, Inc. v. U.S. Dep’t of Health & Hum. Servs.,604 F.3d 445 (7th Cir. 2010). Further, section 483.25(d)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.” Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)). Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision” for a particular resident’s needs. Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub. nom. Windsor Health Ctr. v. Leavitt,127 F. App’x 843 (6th Cir. 2005).
The elopement of a resident from a facility may serve as the basis for a deficiency under section 483.25(d) so long as the elopement was foreseeable. See Heritage Park Rehabilitation and Nursing Center, DAB No. 2231 at 9 (2009) (“[F]oreseeability is an essential consideration in assessing the adequacy of supervision.”). However, section 483.25(d) requires facilities to provide adequate supervision of residents to prevent accidents. Therefore, the facility’s duty under section 483.25(d) is far broader than merely attempting to prevent foreseeable elopements. See Glenoaks Nursing Ctr., DAB No. 2522 at 8 (2013) (citing cases that held that a facility must take all reasonable steps to ensure that a resident receives supervision and assistance devices that meets assessed needs and to mitigate foreseeable risks of harm from accidents).
Petitioner does not dispute that R1 left the facility late on February 24, 2022, or early morning on February 25, 2022, or that facility staff were unaware that he left. Petitioner argues that R1’s condition improved after being admitted to the facility and that R1 was largely able to care for himself. P. Br. at 9. Petitioner points to the February 7, 2022 physician assistant examination that revealed R1 was alert, awake, and oriented (P. Ex. 2 at 2), and the February 4, 2022 assessment showing independent functioning with ADLs (CMS Ex. 4 at 38-40). P. Br. at 9. Petitioner also relies on notes from the state agency surveyors from interviews of facility employees to assert that R1 had a history of sleeping through the night, could use a call light for assistance when needed, did not need incontinent care during the night, and never indicated that he wanted to leave. P. Br. at 9. In addition, Petitioner reasons that APS believed R1’s condition improved because it allowed the Emergency Order to expire. P. Br. at 9-10.
Petitioner argues that it was in substantial compliance with section 483.25(d) because R1, an alert and oriented resident who was his own responsible party, chose to leave the
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facility in the night and neither suffered a serious adverse outcome nor was likely to have suffered a serious adverse outcome. P. Br. at 1. Petitioner states that its WanderGuard system was functioning at the time R1 left the facility and that it was likely that R1 cut the WanderGuard bracelet off before leaving the facility. P. Br. at 10. Petitioner points out that it cannot use restraints or lock the facility doors to prevent someone from leaving the facility. P. Br. at 11. Petitioner indicates that it had several interventions listed in the care plan to try to avoid R1’s elopement. P. Br. at 11; CMS Ex. 4 at 10. Petitioner concedes that the interventions did not include staff checking on R1 while he slept, but Petitioner argues it was not legally required to have such an intervention. P. Br. at 12.
Finally, Petitioner asserts that R1’s elopement was “no accident” because R1 “acted intentionally and deliberately” to leave the facility. P. Br. at 12. Petitioner cites to the testimony of one of its witnesses, Assistant Director of Nursing Maria Perez, LVN (P. Br. at 12), who testified that, on March 16, 2022, she discussed R1’s departure from the facility with him. She stated:
Resident # 1 was able to recall the events between February 24, 2022 and February 27, 2022. He stated that when he left the Facility undetected, it was intentional. He stated that [APS] had informed him that he was no longer under their care. He also stated that he did not want to remain at the nursing home and was afraid he would be forced to stay if he informed staff that he wanted to be discharged. He expressed that he waited for an opportune time to leave and took measures to not be found once he left. He further stated that he is used to living outdoors and it was his preference to continue to live outdoors. When explained that residents are assisted with their discharge when they desire to return to the community, he indicated that he was unaware. He reiterated that he snuck out of the Facility because he thought he would have been forced to remain.
P. Ex. 5. Based on R1’s physical capabilities and right to leave the facility, Petitioner argues that R1’s failure to follow proper discharge procedure is insufficient to show that there was a lack of supervision to prevent accidents. P. Br. at 13; Tr. 26-27. Therefore, there was no deficiency in this case. P. Br. at 13.
I disagree with Petitioner’s argument. Petitioner misconstrues its responsibilities under section 483.25(d). On February 24-25, 2022, Petitioner still had a duty to supervise R1 to ensure that he did not elope from the facility.
By February 25, 2022, R1’s only documented cognitive assessments showed a BIMS score of 5. CMS Ex. 4 at 48, 55. These scores were consistent with the original
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physician’s assessment that R1 lacked capacity to make certain decisions, which resulted in the Emergency Order and R1’s compelled presence at Petitioner’s facility. CMS Ex. 4 at 65, 70, 84.
Further, by February 25, 2022, Petitioner’s care plan entries for impaired cognitive function and elopement risk were still in place. CMS Ex. 4 at 10, 13, 35-36. Petitioner originally assessed R1 as having a moderate risk of elopement and believed that placement of a WanderGuard bracelet on R1 was necessary. CMS Ex. 4 at 58-59, 62-63; Tr. 27, 32 (placement of a WanderGuard indicates that the facility was concerned for R1’s safety). R1’s physician agreed with R1’s care plan and ordered the WanderGuard, and there is no evidence that a physician later ordered removal of the WanderGuard. CMS Ex. 4 at 38-40, 42-43. Despite the February 7, 2022 physician assistant’s examination that indicated R1 was alert and oriented (P. Ex. 2 at 2), there is no evidence that Petitioner reassessed R1’s BIMS score, changed R1’s care plan, or sought to have the physician order for a WanderGuard terminated. Indeed, when the facility reported R1’s elopement to the state agency on February 25, 2022, facility staff provided the state agency with R1’s BIMS score of 5 as assessed in early February. CMS Ex. 5 at 3.
Petitioner’s brief often cites statements by facility staff, as recorded in the surveyor’s notes, as proof that R1’s cognitive ability improved by February 25, 2022, and R1 was no longer an elopement risk. See CMS Ex. 5. However, I do not give these statements the weight I might had they been made in written direct testimony that was subject to cross-examination. More significantly, the statements of facility staff to the surveyors are not supported by documentation from R1’s medical record.
The written testimony from Nurse Perez also suffers from a lack of documentary support. She testified that R1 scored 15 on a BIMS when she discussed the elopement with R1 in March 2022. P. Ex. 5. However, Petitioner did not submit a completed form that Nurse Perez used to conduct and generate that BIMS score. See CMS Ex. 4 at 54-55 (form used for BIMS). As a result, there is insufficient evidence that a BIMS was conducted properly and scored correctly.
While Petitioner did not document many of the alleged improvements in R1’s condition, there is a skilled nursing assessment that, by February 4, 2022, R1 was independent in all assessed matters related to his “Functional Status,” including transfers and walking. CMS Ex. 4 at 38-40. At the same time, R1’s cognitive status remained unchanged, which would mean a BIMS of 5. CMS Ex. 4 at 38. Far from helping Petitioner’s case, R1’s physical independence, while having severe cognitive deficits, meant R1 remained a risk for elopement.
Even if R1’s cognitive abilities improved by February 25, 2022, and the facility had known that the Emergency Order expired, Petitioner still needed to try and avoid R1’s elopement. There is a distinction between known, voluntary departures and unknown,
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unsupervised exits. Heritage Park, DAB No. 2231 at 9-11 (“If staff had known that [the resident] was leaving, staff could have ascertained where the resident was going, how long he was to be gone, who he was with, and thus ensured the resident went with proper clothing and medicine.”). Had facility staff witnessed R1 leave, they would likely have tried to persuade him to stay long enough to go through the discharge process, in which the facility could have tried to help him obtain necessary services or ensure his safe return to the property where he previously lived. See CMS Ex. 4 at 11 (Petitioner updated R1’s care plan on February 25, 2022, to add goals of obtaining from R1 the assistance that he needs and the services required to meet his needs before discharge).
Based on the record, as explained above, I conclude it was foreseeable that R1 may elope from the facility and that Petitioner did not provide adequate supervision to mitigate that risk. R1 had a care plan entry with a “Focus” statement that “[t]he resident is an elopement risk/wanderer,” with a “Goal” that “[t]he resident will not leave facility unattended through. . . .” CMS Ex. 4 at 10. This care plan was in effect when R1 eloped from the facility. Therefore, it was foreseeable that R1 may try to elope.
Further, the care plan listed four interventions, three of which involved wandering. Only one intervention, the placement of a WanderGuard, was directed at potential elopement. CMS Ex. 4 at 10. And, that WanderGuard bracelet could be easily removed by cutting the band with a pair of scissors. Tr. 34-35. In fact, Petitioner’s witnesses speculate that R1 removed the WanderGuard bracelet before leaving the facility. P. Exs. 1, 3. This was an inadequate intervention.
Use of WanderGuard is not actually supervision, but an alarm system “to alert staff if resident attempts to exit facility unassisted.” CMS Ex. 4 at 10; Tr. 33. Considering the assessed risk of elopement, leaving R1 alone all night without any periodic checks was not adequate supervision. Therefore, I conclude that Petitioner was noncompliant with 42 C.F.R. § 483.25(d).
5. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d) posed immediate jeopardy to resident health and safety is not 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. The regulation does not require that a resident actually be harmed. Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).
I must uphold CMS’s determination as to the level of a facility’s noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c). The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and DAB cases have sustained determinations of
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immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)). In reviewing CMS’s finding, I “must consider whether the totality of the allegations support the Agency’s determination that [the facility’s] noncompliance ‘has caused, or [was] likely to cause, serious injury, harm, impairment, or death to a resident.’” Rosewood Care Ctr., 868 F.3d 605, 618 (7th Cir. 2017) (Emphasis omitted).
Petitioner argues that there was no immediate jeopardy because R1 did not suffer a serious adverse outcome as can be seen by the hospital’s determination, after R1 was found on February 27, 2022, that R1 did not need to be admitted and could be discharged to a homeless shelter. P. Br. at 13-14. Petitioner argued: “A mere risk or potential of serious harm is not equivalent to a likelihood of serious harm, and the degree of likely harm is itself a question of fact. Innsbruck HealthCare Ctr., DAB No. 1948 (2004).” P. Br. at 14. Petitioner further argued:
CMS claims that the facilities alleged failures “led to R1 spending two-and-a-half days outside of the facility during the winter.” (CMS Post-Hearing Brief, p. 10). However, there is no causal connection between any of the alleged failures of the facility and Resident # 1 spending time outside. Resident # 1 had a history of homelessness and was accustomed to living outdoors. (Pet. Ex. 1, p. 1; Pet. Ex. 3, p. 1). Resident # 1 knew how to acquire food, shelter, and protection while living outdoors. Id. During the two days before Resident # 1 was located, the local police department did not continue to search for Resident # 1 because they did not believe he was in danger. (CMS Ex. 5, pp. 14, 28, 31).
P. Br. at 14-15.
Petitioner’s arguments are insufficient to show that CMS’s determination is clearly erroneous. As an initial matter, R1 left in the middle of the night. Nighttime is inherently more dangerous due to the general lack of light. Further, when the state agency received notice from Petitioner on February 25, 2022, that R1 eloped, it noted on the intake documentation that: “Per online weather search, Castroville, TX high is 42F and low is 36F with 24% precipitation.” CMS Ex. 5 at 3. Therefore, leaving at night subjected R1 to temperatures near freezing. Extended exposure to such cold temperatures for an elderly man is obviously dangerous. Assuming that the high temperature occurred during daylight hours, R1 was exposed to temperatures in the mid-30’s to low 40’s for more than two days before R1 was found. When he was found, his only shelter was under a bridge. P. Ex. 4 at 1. While that may have protected him from wind and rain, it would do little to keep him warm.
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Further, Petitioner asserts that R1 knew how to acquire food. Despite this, the hospital physician who examined R1 stated that R1 was very hungry because he did not eat for the last few days and that the hospital would give him food. P. Ex. 4 at 1. Obviously, food is a necessity and R1 was incapable of obtaining it.
Although Petitioner waives off any danger to R1 because he had been homeless and allegedly knew how to survive that way, Petitioner does not account for the fact that, while R1 was considered homeless before entering the facility, he was living in a car located on land owned by his friends. CMS Ex. 4 at 79. When R1 eloped from the facility, R1 did not even have that modest place to live.
Finally, Petitioner was diagnosed with hypertension and prescribed Amlodipine. CMS Ex. 4 at 1, 44-45, 82; P. Ex. 2 at 2. R1’s care plan included an entry for hypertension, which required staff to give R1 the hypertension medication as ordered and to monitor for signs and symptoms of malignant hypertension. CMS Ex. 4 at 12. R1 did not have his needed medication when he eloped and he was no longer monitored. Tr. 23. Immediate jeopardy can be based on risks posed to residents by being away from the facility when medical monitoring and medication administration are needed. Eastwood Convalescent Center, DAB No. 2088 at 16-17 (2007). In this case, R1’s elopement made monitoring and administration of needed medication impossible.
Based on the foregoing, I conclude that CMS did not clearly err in determining that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d) posed immediate jeopardy to the health and safety of its residents.
6. The $10,780 per-instance CMP is reasonable under relevant statutory and regulatory factors for determining the amount of CMPs.
When determining whether a CMP amount is reasonable and appropriate, I apply the factors 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). 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 administrative law judge, requiring only that the
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regulatory factors at §§ 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). However, unless a facility contends that a particular regulatory factor does not support the CMP amount, an administrative law judge must sustain it. Coquina Ctr., DAB No. 1860 (2002).
Petitioner contends that the findings of noncompliance at the immediate jeopardy level was improper; therefore, the CMP is unreasonable.7 P. Br. at 15. Because Petitioner did not contend that a particular regulatory factor does not support the CMP amounts, I must sustain them. Coquina Ctr., DAB No. 1860 (2002).
V. Conclusion
1. CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) is sustained.
2. CMS did not clearly err when it determined that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d) posed immediate jeopardy to resident health and safety.
3. The $10,780 per-instance CMP is reasonable.
Scott Anderson Administrative Law Judge
- 1
Congress enacted these requirements into law through the Federal Nursing Home Reform Act (FNHRA).
The FNHRA provisions . . . stem from a longstanding national commitment to provide safe and dignified care for the elderly. Since as early as the Social Security Act of 1935, federal law has aimed in myriad ways to promote nursing homes that provide quality services. Yet, concerns about the poor condition of such facilities persisted even after Congress enacted the 1965 Medicare and Medicaid Acts, partly due to widespread noncompliance with existing federal and state laws. Thus, in 1987, Congress passed, and President Ronald Reagan signed, the FNHRA, effecting a “seismic shift” in nursing-home quality standards. The FNHRA is largely composed of a litany of statutory requirements that Congress laid out for Medicaid-participant States and “nursing facilities.”
Health & Hosp. Corp. of Marion Cnty. v. Talevski, 599 U.S. 166, 180-82 (2023) (internal citations omitted).
- 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
“[FNHRA] creates a reticulated remedial regime that both balances federal and state enforcement and channels disputes through that regime. . . . Consider the remedial provisions that [FNHRA] provides. When federal officials find that a nursing home does not comply with FNHRA, [FNHRA] enumerates certain limited remedies they can pursue, such as withdrawing federal funding and imposing civil penalties . . . .” Talevski, 599 U.S. at 232-33 (Alito, J., dissenting).
- 4
Given that this assessment was made on R1’s first day at Petitioner’s facility, the reference to a previous attempt to leave the facility may have been based on R1’s previous elopement from an assisted living facility. CMS Ex. 5 at 3.
- 5
A BIMS reviews a resident’s cognitive ability at that moment and is usually conducted by a social worker. Tr. 9-10. BIMS scores of 13 to 15 are intact cognition and 8 to 12 is moderately impaired cognition, and 0 to 7 is severely impaired cognition. Tr. 10. BIMS scores of 13 to 15 means the person can make decisions for themselves. Tr. 10. Although residents with BIMS scores of 13 to 15 can make their own decisions, cognition may fluctuate throughout the day. Tr. 10-11.
- 6
CMS revised part 483 regulations concerning facility conditions of participation in 2016, including the quality of care regulation found at 42 C.F.R. § 483.25. 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections). The accident prevention regulation was formerly found in 42 C.F.R. § 483.25(h). Therefore, I consider case decisions discussing former section 483.25(h) when deciding this case.
- 7
Petitioner also objected to the loss of the facility’s NATCEP. P. Br. at 15. However, Petitioner did not expressly dispute the finding of substandard quality of care, and Petitioner did not raise that as an issue in this case. Therefore, I uphold the loss of the NATCEP because I have otherwise upheld CMS’s findings of noncompliance at the immediate jeopardy level, which were the basis for CMS’s finding of substandard quality of care.