Generations at Regency, DAB CR6989 (2026)

DECISION

After carefully considering this record, I affirm the Centers for Medicare and Medicaid Services’ (“CMS”) determination that Generations at Regency (“Petitioner” or “Facility”) was in substantial noncompliance with Medicare participation requirements.  Further, I conclude the civil money penalty (“CMP”) imposed in this matter is reasonable.

I.     PROCEDURAL HISTORY

Petitioner is a skilled nursing facility (“SNF”) located in Niles, Illinois, that participates in the Medicare program. On October 26, 2023, the Illinois Department of Public Health (“IDPH”) completed a Complaint Survey at the facility to determine if the facility was in compliance with the federal requirements for nursing homes participating in the Medicare and Medicaid programs.  The survey found that the facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2) (Tag F689), cited at scope and severity level G (isolated instance of substantial noncompliance that causes actual harm but does not pose immediate jeopardy to resident health and safety) and with 42 C.F.R. § 483.25 (Tag F684), cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimum harm that is not immediate jeopardy).

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On February 22, 2024, CMS sent a Survey Findings and Imposition/Disposition of Remedies letter to Petitioner, notifying it of the imposition of a CMP of $1,530 per day for the seventeen (17) days beginning October 23, 2023 and continuing through November 8, 2023, for a total of $26,010. Due to the total penalty amount, Petitioner was also statutorily barred from offering a Nurse Aide Training and Competency Evaluation Program (“NATCEP”).  In its letter, CMS indicated it initially imposed the following penalties: discretionary denial of payment for new admissions (DPNA) effective November 18, 2023; and federal civil money penalty. However, the IDPH conducted a revisit of the facility and found it was in substantial compliance as of November 9, 2023.  As a result, CMS did not impose mandatory termination and rescinded the DPNA.

On April 19, 2024, Petitioner filed a request for hearing with an Administrative Law Judge (“ALJ”) at the Departmental Appeals Board’s Civil Remedies Division.  Hr’g Req.   CMS filed its brief (CMS Br.) and 25 exhibits (CMS Exs. 1-25).  Petitioner filed its brief, along with 31 exhibits (P. Exs. 1-31).  CMS filed a reply (CMS Reply). Petitioner did not object to any of CMS’s exhibits, and CMS did not object to any of Petitioner’s exhibits.  Absent objections from the parties, I admit the exhibits into the administrative record.

October 9, 2024, the parties waived their right to an oral hearing and requested a decision on the written record.  Joint Settlement Status Report.  The undersigned ALJ is issuing this decision on-the-record, pursuant to 42 C.F.R. § 498.66.

II.     ISSUES

1. Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25;
2. If Petitioner was not in substantial compliance, whether the amount of the CMP imposed is appropriate under the factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).

III.     APPLICABLE LAW

The Social Security Act (“Act”) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health & 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. Part 483.   To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.” 42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance.  Act § 1864(a); 42 U.S.C.

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§ 1395aa(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually and surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  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 Secretary has delegated to CMS and the states the authority to impose remedies against a skilled nursing facility that is not in substantial compliance with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b).  If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an ALJ to challenge the noncompliance finding that leads to the imposition of an enforcement remedy.  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).  CMS has the burden to produce evidence sufficient to make a prima facie case that Petitioner is out of substantial compliance with participation requirements to establish a basis to impose an enforcement remedy.  See, e.g., Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  If CMS makes this prima facie showing, then the Petitioner must show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance with participation requirements.  Id.

IV.     FINDINGS OF FACT AND ANALYSIS

Resident R6

At issue is whether the facility failed to maintain substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2), (Tag F689), cited at scope and severity level G (isolated instance of substantial noncompliance that causes actual harm but does not pose immediate jeopardy to resident health and safety), regarding the care and supervision provided to Resident R6.

The opening provision of 42 C.F.R. § 483.25, which implements sections 1819(b)(2) (Medicare) and 1919(b)(2) (Medicaid) of the Social Security Act, states:

Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices…

See 42 U.S.C. § 1395i-3(b)(2); 42 U.S.C. § 1396r(b)(2).

Further, 42 C.F.R. § 483.25(d)(1) and (2) require the facility to ensure that-

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(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.

Therefore, subsection 483.25(d)(1) requires that a facility 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 accident to the extent possible.”  Me 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 10 (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, subsection 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 material facts in this case are not in dispute.  On May 27, 2023, Resident R6 (“R6”), an 84-year-old male, was re-admitted to the Petitioner’s facility.  His preferred language was Polish. CMS Ex. 8 at 1.  His diagnoses included heart failure, unspecified (primary) and acute pyelonephritis. Other diagnoses were metabolic encephalopathy, altered mental status, bilateral primary osteoarthritis of knee, primary osteoarthritis right shoulder, primary osteoarthritis left shoulder, other intervertebral disc degeneration lumbar region, other obstructive and reflux uropathy-obstructive uropathy, muscle weakness (generalized), unspecified dementia, urinary tract infection, and benign prostatic hyperplasia with lower urinary tract symptoms.  CMS Ex. 8 at 2; P. Ex. 1.  R6’s care plan also reflected that he was diagnosed with unsteadiness on feet, need for assistance with personal care, and other abnormalities of gait and mobility.  CMS Ex. 9 at 1; P. Ex. 1.  R6 also presented with a functional deficit, which appeared to be related to his muscle weakness.  CMS Ex. 9 at 19.  His plan of care indicated his need for a wheelchair or walker to ambulate.  CMS Ex. 9 at 19, 52. The plan of care also indicated the resident was at risk for falling due to poor safety awareness related to dementia, with a start date of July 30,

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2020.  CMS Ex. 9 at 57.  The stated goal was to “remain free from fall-related injury…”  Id.   Interventions included: providing toileting assistance before and after meals, activities, bedtime, and as needed (PRN); verbal reminders not to ambulate or transfer without assistance; frequent observations and placing him in high-traffic areas when out of bed; keeping the call light within reach; keeping the bed in the lowest position with brakes locked; keeping floors clear of glare, liquids, and clutter; encouraging use of hand grips and handrails; keeping personal items within reach; NP medication reviews; PT/OT referrals post-fall; encouraging slow standing; assuring proper footwear; and providing meaningful distractions.  CMS Exs. 9-10.  The care plan noted the resident “is not able to use the call light system secondary to limited poor cognitive ability and lack of recognition of the purpose of the call light.”  CMS Ex. 9 at 14.

On June 16, 2023, R6 fell in his room while dressing. CMS Ex. 8 at 7-8.  On June 19, 2023, Regency updated R6’s care plan to include an intervention requiring staff to provide R6 with a bedside floor mat and referred R6 to skilled therapies post-fall.  CMS Ex. 9 at 57-58, 70; CMS Ex. 8 at 8.

The physical therapy (“PT”) and occupational therapy (“OT”) evaluations and plan of care, indicated the resident was unsteady when walking, had a history of falls, and impaired safety awareness.  P. Ex. 18 at 4-10.  The PT discharge summary dated July 14, 2023, indicated the resident required supervision or touching assistance with lying to sitting on side of bed, partial/moderate assistance with sit-to-stand transfers and toileting transfers, and ambulated 150 feet with partial/moderate assistance and assistive device.  Id. 1-3.  The OT discharge summary dated August 17, 2023, indicated the resident was able to perform sit-to-stand transfers with supervision, toilet transfers with moderate assistance, and had fair dynamic standing balance.  P. Ex. 19 at 1-3.  Both evaluations noted prior use of a walker, and the OT evaluation noted prior use of a manual wheelchair.  P. Ex. 18 at 7; P. Ex. 19 at 6.

The nurse’s note dated July 8, 2023, at 4:10 a.m. indicated the resident fell while attempting to ambulate in his room without assistance.  He was observed ambulating in the hall without an incontinence brief approximately 40 minutes earlier.  There were no witnesses.  An ambulance was called.  He was oriented x 1. He had a laceration to the occipital region, and an ice pack and dressing were applied.  The resident’s statement was noted as “unable to verbalize due to dementia.”   CMS Ex. 8 at 6–7; P. Ex. 3; P. Ex. 4 at 1–2.  The Fall Details Report dated July 8, 2023, indicated the fall type was “visually observed on floor;” the call light was off; cane, walker, wheelchair, and restraints were not in use; and he had a low bed. CMS Ex. 8 at 7; P. Ex. 4 at 2; P. Ex. 29.  The follow-up report dated July 8, 2023, indicated the resident was found supine next to the bed. A fall mat was placed at his bedside when he returned from the emergency department.  He had poor safety awareness despite increased rounding and frequent reminders and redirection.  A position change alarm was placed to assist in reminding the resident and alerting staff to assist. CMS Ex. 8 at 8; P. Ex. 4 at 3.

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The nurse’s note dated August 10, 2023, at 7:28 p.m. indicated the resident was observed wearing shoes that were bigger than his feet and walking with an unsteady gait.  CMS Ex. 8 at 10.  The nurse attempted to assist the resident, but he was non-compliant and resistant to care.  Id.  He was at the bathroom door, lost his footing, and fell backwards.  Id. His cognition after the fall was disoriented.  He did not have any visible injury but hit the back of his head on the floor as he fell backwards.  Immediate actions taken included neuro checks initiated, first aid, alert charting initiated, ice pack applied, family notified, pain assessment, encouraging the resident to ask for assistance before standing, pain collection data tool initiated, 911 emergency transfer, head-to-toe body check, dressing applied, keeping the walker within reach, MD notified, reinforcing the use of assistive devices, and monitoring for further support.  CMS Ex. 8 at 9–10.  The Fall Details Report dated August 10, 2023, indicated the resident fell backwards onto his bottom, hitting the back of his head. The nurse attempted to break the fall but was unable to reach him.  The call light was off, he was wearing poorly fitted shoes, and cane, walker, wheelchair, and restraints were not in use.  Id. at 10–11; P. Ex. 29.  The follow-up report dated August 11, 2023, indicated staff ensured only properly fitting shoes were present.  CMS Ex. 8 at 11–12.

The Affidavit of Marcia Walker, LPN, indicated she worked with R6 on the fifth floor. She was the staff member who witnessed R6’s fall on August 10, 2023. P. Ex. 8 at 1.  She stated, “On the dates of both incidents monitoring of R6 and all residents was consistently ongoing throughout my shift…R6’s room was in an area of high staff traffic…where staff could respond to alarms more quickly than other placement on the floor.” P. Ex. 8 at 2.  The psychiatry physician note dated August 25, 2023, indicated the resident was seen after being hospitalized for a fall. He was confused and had poor insight and judgment.  The physician decreased his evening Memantine. P. Ex. 21 at 3.  On August 14, 2023, Petitioner discontinued R6’s July 9, 2023 intervention to provide R6 with a bed alarm. On August 18, 2023, Petitioner discontinued R6’s bedside floormat intervention as a duplicate.  On September 8, 2023, Petitioner discontinued R6’s June 19, 2023 bedside floormat intervention.  On September 8, 2023, Petitioner initiated an intervention stating R6 may use a bed alarm while in bed. CMS Ex. 9; CMS Ex. 10 at 14, 18; P. Exs. 14-17.

The nurse’s note dated September 25, 2023, at 9:54 p.m. indicated that while doing rounds, a certified nursing assistant (CNA) observed the resident on the floor in a sitting position next to his bed.  No skin injuries were noted. He was able to move all extremities at baseline. Due to his cognitive impairment, he was unable to give a statement of what happened. CMS Ex. 8 at 13–14; P. Ex. 8.  The Fall Details Report dated September 25, 2023, indicated the resident was visually observed on the floor. The call light was off, walker and wheelchair were not in use, and bed rails were not applicable. CMS Ex. 8 at 14; P. Ex. 21.  The fall risk assessment performed on September 25, 2023, indicated the resident had balance problems while walking and was at a high risk for falls.  No new referrals were made, and the plan was to continue the current plan of care. Due to cognitive impairment, he was unable to state pain location or level, and staff assisted him back to bed. P. Ex. 6 at 1-2.  The nursing note dated September 26, 2023, indicated the resident was

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seen after a fall where he was found on the floor by his bed. The plan was to order labs, review medications, and continue monitoring.  P. Ex. 22.  The follow-up report dated September 29, 2023, indicated toileting assistance prior to bed was implemented. Prior to the fall, the resident was noted to have had an episode of incontinence.  CMS Ex. 8 at 15.

The nurse’s note dated October 1, 2023, at 11:40 a.m. indicated a CNA observed the resident lying on the floor on his left side behind his room door. CMS Ex. 8 at 16.   He had a left temple abrasion with slight bleeding and swelling to his left cheek and left ear.  He was oriented x 1.  His daughter requested to have her father’s room moved closer to the nursing station.  He was unable to give a statement of what happened due to cognitive impairment.  CMS Ex. 8 at 16–17; P. Ex. 11.  The Fall Details Report dated October 1, 2023, indicated the resident was found lying on the floor on his left side near his door. The call light was off and his wheelchair was not in use.  CMS Ex. 8 at 17–18; P. Ex. 29.  The Affidavit of Veronic Has, CNA, indicated she worked with R6 on the fifth floor, stating: “At around 11:40 am, I heard the bed alarm and a commotion from R6’s room. We entered R6’s room and we noted him on the floor near the door.”  P. Ex. 12 at 1.  The follow-up report dated October 24, 2023, indicated the resident attempted to get out of bed unassisted and was found with a bed sheet wrapped around his lower extremity, which caused him to fall.  The resident was subsequently admitted to inpatient hospice and did not return to the Facility.  CMS Ex. 8 at 18.  All listed care plan items related to his mobility issues and need for assistance were documented as discontinued on October 4, 2023.  CMS Ex. 8; P. Ex. 10; P. Exs. 13-17.

Here, the undersigned finds the Facility was noncompliant with 42 C.F.R. § 483.25(d)(1) and (2).  The Statement of Deficiencies states, “Based on interview and record review, the facility failed to have effective interventions in place to keep a resident free from fall related injury for a resident with a history of falls.  This failure applied to one (R6) of one resident reviewed for accidents and supervision and resulted in R6 experiencing four falls in four months and sustaining a laceration to the head requiring three staples and [sustaining] a subdural hematoma.” CMS Ex. 1.  These assertions in the Statement of Deficiencies are supported by the record.

Resident R6 fell four times in four months.  Two of these falls resulted in head injuries requiring hospitalization, and after the fourth fall, he entered inpatient hospice care.  Three of the falls occurred while he was unsupervised.  The Facility argues that R6 was provided extensive care and supervision, but his declining condition and dementia made certain falls unavoidable. CMS Ex. 21, 21; P. Br.  However, the regulations require a facility to manage the unavoidable hazard by reducing the risk of accident to the extent possible and provide reasonable and adequate supervision necessary to prevent foreseeable accidents.  The resident had severe cognitive impairment, unsteady gait, impaired safety awareness, balance problems while walking, high risk for falls, and a history of multiple unwitnessed falls. Despite this, the care plan directed staff to “keep call light in reach at all times,” while simultaneously acknowledging the resident “is not able to use the call light system

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secondary to limited, poor cognitive ability.”  CMS Ex. 9 at 14, 59. Other interventions, such as verbally reminding him not to ambulate without assistance, were inherently ineffective because his advanced dementia prevented him from comprehending or remembering these instructions.  Other interventions in place such as assisting with toileting, frequent reminders, redirect resident, and bedside floormat, were either duplicated or discontinued, and the facility did not provide any evidence showing their effectiveness at avoiding falls.  The facility relied on interventions it knew the resident could not use and prematurely removed protective safety devices, failing to meet the standard of substantial compliance under 42 C.F.R. § 483.25(d).

Additionally, R6 had a known history of urinary incontinence. CMS Exs. 8-9. The follow-up report after his September 25, 2023 fall noted he experienced an episode of incontinence prior to falling.  Yet the report indicates toileting assistance before bedtime was not implemented until after this third fall, even though the care plan mentions toileting assistance before bedtime that was initiated on July 2020 and August 2020 (toileting assistance every two hours).  CMS Ex. 8 at 1; CMS Ex. 9; CMS Ex. 25 ¶ 22; CMS Br. At 12.  The record does not show the facility provided toileting assistance every two hours. The Declaration of Stephanie Sims, IDPH surveyor, correctly notes that this critical intervention was delayed despite R6’s clear history of incontinence and late-night falls. See CMS Ex. 25 ¶ 22 (Sims Decl.).

Furthermore, the facility’s Falls Prevention and Management Policy, reviewed in February 2023, specifically recognizes that “Alarms may be a useful method of alerting staff of a resident’s movement which may pose a risk to their safety” and mandates that staff “maintain communication . . . when situations or resident behaviors suggest that the current intervention(s) are not effective” and “re-evaluate as needed to promote safety.” CMS Ex. 12. On September 8, 2023, Petitioner initiated an intervention stating that R6 may use a bed alarm while in bed. CMS Ex. 9; P. Ex. 10, 13–17.  The Affidavit of Veronic Has, CNA, indicated “At around 11:40 am, I heard the bed alarm and a commotion from R6’s room. We entered R6’s room and we noted him on the floor near the door.” P. Ex. 12 at 1.

Here, the record demonstrates that the alarm failed to provide the timely alert contemplated by the facility’s policy and required under 42 C.F.R. § 483.25(d)(2).  The CNA heard the alarm concurrently with a "commotion," and upon entering the room, staff found R6 already on the floor by the door with a bed sheet entangled around his lower extremity. CMS Ex. 8 at 16–18; P. Ex. 12 at 1.  Because the alarm sounded only as R6 was already falling—after he had fully exited the bed, crossed the room, and become entangled in bedding—the intervention failed to afford staff any practical opportunity to assist R6 or prevent the fall.

CMS argues that, as part of ongoing supervision, the resident should have been moved closer to the nursing station. See CMS Br. Conversely, the Facility contends that R6’s room was ideally situated to be in the most high-traffic space on the floor to address his desire to

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spend time in his room, resting or napping. R6 was provided high-quality care that respected his dignity of choice and also provided him with adequate supervision to meet his needs.”  See P. Br. Supporting this, the staff affidavits of Margaret Cyran, LPN, Carmen Borka, CNA supervisor, Voshunda Dunckins, CNA, and Sonia Aknouche, LPN, state: “R6's room was located next to the dining room . . . in an area of high staff traffic. R6’s room was also in an area where staff could respond to alarms more quickly than other placement on the floor.”  P. Exs. 25-28.

Here, the resident’s falls occurred at various times of the day. R6’s unobserved falls on July 8, 2023 (4:10 a.m.) and September 25, 2023 (9:54 p.m.) occurred during times when these common areas are not high-traffic.  CMS Ex. 8 at 6, 13.  His last fall occurred on October 10, 2023, at 11:40 a.m., a time when a higher staff presence in the common areas would normally be expected. P. Ex. 12.  Further, after his multiple falls, his daughter even requested to have her father’s room moved closer to the nursing station.  CMS Ex. 8 at 16–17; P. Ex. 11.  There is no evidence that Petitioner considered implementing this intervention or a medical reason was given as to why he should not have been moved closer to the nurse’s station.  Given his severe cognitive decline, unsteady gait, and high fall risk, placement in a high-traffic common area was insufficient.  He would have clearly benefited from being situated closer to the nursing station receiving heightened monitoring and one-on-one supervision.

Due to the resident’s advanced age, underlying comorbidities, history of urinary incontinence, unsteady gait, muscle weakness, poor cognitive issues where he was unable verbalize needs or comprehend, history of dementia, and history of falls, the Facility should have taken reasonable steps to increase R6’s supervision to include implementation of one-on-one supervision, more frequent room checks, or moving him closer to the nursing station.  The facility failed to take all reasonable steps to ensure to mitigate the foreseeable risk of harm that resulted in multiple falls, injury, and ultimately discharge to inpatient hospice care.  Briarwood, DAB No. 2115 at 11.  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) with respect to R6.

Resident R3

At issue is whether the facility failed to maintain substantial compliance with 42 C.F.R. 483.25, (Tag F684), cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimum harm that is not immediate jeopardy).

Under 42 C.F.R. § 483.25 (Quality of care), a facility must ensure that a resident receives treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices, based on the resident’s comprehensive assessment. Implicit in this mandate is the fundamental duty to maintain and communicate accurate medical records, particularly during the transition of

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care.  See Lutheran Home, DAB No. 3146 at 4 (2024).  Providing receiving medical providers with a resident’s correct diagnoses, medication regimens, and identifying information during an emergency transfer is a basic professional standard of practice essential to ensuring the continuity of safe, high-quality care.  CMS Ex. 16 at 3-4.  Petitioner does not dispute that that is the professional standard of practice.  See P. Br.

The undisputed evidence establishes that the facility failed to meet the quality-of-care requirements mandated by 42 C.F.R. § 483.25 during the emergency transfer of Resident R3. The record reflects that Resident R3 is a 66-year-old female with an admitting diagnosis of acute on chronic diastolic congestive heart failure and a primary diagnosis of iron deficiency anemia secondary to chronic blood loss.  CMS Ex. 13 at 1-6.  On September 8, 2023, Resident R3 suffered an acute medical event, becoming unresponsive to verbal stimuli and experiencing a drop in oxygen saturation to 88%. Facility staff correctly recognized the need for emergent acute care and contacted 9-1-1. Id. at 7.

However, during the transfer process, the registered nurse on duty (V10) admittedly provided the paramedics with the face sheet and full Physician Order Sheet—detailing medications and diagnoses—belonging to a different resident, Resident R2.  CMS Exs. 16-17.  Resident R2 is a 71-year-old female whose clinical profile includes an admitting diagnosis of encephalopathy.  CMS Ex. 14.  Consequently, an unresponsive Resident R3 was transported to the hospital and admitted under the identity and medical history of Resident R2.  CMS Exs. 16-17.  The hospital clinicians receiving an unresponsive patient were fundamentally misled regarding the patient’s identity, underlying disease processes (heart failure versus encephalopathy), and current pharmacological interventions.  CMS Ex. 16 ¶ 18.  The facility’s error was only discovered because Resident R3’s husband arrived at the hospital, was informed there was no record of his wife being admitted, and subsequently contacted the facility, prompting Nurse V10 to realize the mistake.  Id.; CMS Ex. 17 at 2.

Providing emergency room personnel with an incorrect medical history for a critically ill, unresponsive patient constitutes a severe deviation from professional standards of practice. As the facility’s own Director of Nursing (V2) conceded during an October 24, 2023 interview, this incident “could have adversely affected the care R3 received while in the hospital if no one would have caught it.”  CMS Ex. 16 ¶ 19 (citing CMS Ex. 1 at 3).  The facility effectively placed Resident R3 at immediate risk of receiving contraindicated clinical interventions based on Resident R2’s medical profile. The Statement of Deficiencies, indicated on October 24, 2023, V2 said, “I am aware R2 was transferred to the hospital with the documents of another resident. I think the nurse in the middle of the night was tired and maybe anxious and somehow got the wrong paperwork. We are all human and we make mistakes. I did an in-service with the nurse but not the whole staff . . . .  I don't think we have a policy regarding this issue, but I think that it would go hand in hand with the ‘rights’ of the patient-such as making sure we are providing the right care to the right person at the right time and so on. I recognize that this incident could have

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adversely affected the care R3 received while in the hospital if no one would have caught it.” CMS Ex. 1 at 3.

The facility's failure to accurately identify Resident R3 and ensure the transmission of her correct medical records during an emergency transfer demonstrates a failure to provide care in accordance with professional standards of practice. Accordingly, I conclude that the facility was not in substantial compliance with the quality-of-care requirements set forth at 42 C.F.R. § 483.25.

Right to a Hearing as to the Facility’s Star Rating

The Petitioner argues that the publication of survey results and the impact on the star rating, prior to hearing, violates their due process rights. P. Br. at 19-23.  The Petitioner requests that “the citations in question be deleted, that the CMP be removed, and that all publication, including the use of these citations for calculation of the Facility’s ‘5-Star Quality Rating’ be deleted. Further, the Facility respectfully requests that any such publication be stayed pending the outcome of this hearing.”  P. Br. at 1.  The Petitioner further states that “Regency suffers a deprivation of its right to due process when deficiencies are posted to public websites, made part of the public record, and are published for use by potential clients and referral sources without the benefit of a final determination at a hearing.”  P. Br. at 20.  In its reply brief, CMS contends that “Generations has no right to appeal its Star Rating on CMS’s Care Compare website, or CMS’s publication or posting of the Statement of Deficiencies, as required by the Medicare statute and federal regulations.”  CMS Reply Br. at 8.

The right to an ALJ hearing for a long-term care facility is established by federal regulations at 42 C.F.R. Part 498.  A provider dissatisfied with CMS’ initial determination is entitled to further review, but administrative actions that do not constitute initial determinations are not subject to appeal.  42 C.F.R. § 498.3(d).  A finding of noncompliance that results in the imposition of a remedy specified in 42 C.F.R. § 488.406 is an initial determination for which a facility may request a hearing.  42 C.F.R. § 498.3(b)(13).  Unless the finding of noncompliance results in the actual imposition of a specific remedy, the finding is not an initial determination.  42 C.F.R. § 498.3(d)(10)(ii).

CMS imposed per-instance CMPs for the deficiencies cited under 42 C.F.R. § 483.25(d).  My review is limited to only those alleged deficiencies.  I have no authority to review those deficiencies for which no penalty is imposed.  The Departmental Appeals Board (“the Board”) has long held that a facility has no right to a hearing unless CMS seeks to impose or actually imposes a remedy.  The Lutheran Home – Caledonia, DAB No. 1753 (2000); Schowalter Villa, DAB No. 1688 (1999); Arcadia Acres, Inc., DAB No. 1607 (1997); see also San Fernando Post Acute Hosp., DAB No. 2492 at 7-8 (2012).  The remedy, not the citation of a deficiency, triggers the right to hearing.  Schowalter Villa, DAB No. 1688; Arcadia Acres, Inc., DAB No. 1607.  Where CMS does not impose a

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remedy, Petitioner has no hearing right.  See Fountain Lake Health & Rehab., Inc., DAB No. 1985 (2005).

In its decision in Generations at Regency Center, DAB No. 2950 (2019), the Board examined arguments that are similar to those Petitioner raises.  In that case, the Board found that “the potential harm to a facility’s reputation or financial status that may flow from the publication of deficiency findings does not trigger appeal rights under the Act or regulation.”  Generations at Regency Ctr., DAB No. 2950 at 7 (citing San Fernando Post Acute Hosp., DAB No. 2492 at 13).  The undersigned rejects Petitioner’s argument that it has a right to a hearing or a right to litigate those deficiencies for which CMS seeks no remedy.  Accordingly, Petitioner’s request to litigate those deficiencies for which CMS seeks no remedy is dismissed.  42 C.F.R. § 498.70(b).

V.     REASONABLENESS OF PENALTY ASSESSED

When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF. 42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  All enforcement remedies imposed on SNFs 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.”  42 C.F.R. § 488.402(a)-(b).  In order to assist a facility in returning to substantial compliance quickly, SNFs must file a plan of correction with the state agency/CMS.  42 C.F.R. § 488.402(d).

When determining whether a CMP amount is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I). The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors listed in 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies. See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at §§ 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 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  “[T]here 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.”  Coquina Ctr., DAB No. 1860 (2002).

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Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it. Coquina Ctr., DAB No. 1860.  At the time CMS imposed the CMP in this case, the applicable per-day CMP ranged from $129 to $7,752 per-day for noncompliance that did not pose immediate jeopardy to the health and safety of residents. 42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (2023) (adjusted for inflation).

Here, CMS imposed a CMP of $1,530 per day for the seventeen (17) days beginning October 23, 2023 and continuing through November 8, 2023, for a total of $26,010. Due to the penalty amount, the Petitioner was also barred from offering a NATCEP. In the present matter, Petitioner challenges the imposition of the CMP as “unreasonable because there is no non-compliance of a severity level found in these facts to support this CMP.” See P. Br. CMS contends that “[t]he per-day range available in 2023 for non-immediate jeopardy deficiencies was $129 to $7,752. The $1,530 per-day CMP— roughly 20% of the maximum that could have been imposed—is reasonable given the facility’s culpability, as shown by R6’s repeated falls and injuries, and [Petitioner] has not introduced any evidence of financial hardship. And with the $26,010 total CMP, the two-year NATCEP prohibition is required by statute.” See 42 U.S.C. § 1395i-3(f)(2)(B); 42 U.S.C. § 1396r(f)(2)(B).”

Other than to assert that the CMP was “unreasonable because there is no non-compliance of a severity level found in these facts to support this CMP”, Petitioner has not presented any specific argument addressing the factors cited in 42 C.F.R. § 488.438(f)(1)-(4) and/or 42 C.F.R. § 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)); the regulations for assessing the reasonableness of the CMP.  P. Br. at 23. A SNF may challenge a determination of noncompliance that led to the imposition of a CMP (or other enforcement remedy) by requesting a hearing before an ALJ and appealing any unfavorable ALJ decision to the Departmental Appeals Board (Board).  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13), 498.5(a)-(c).  The scope of ALJ or Board review may include whether the amount of the CMP is reasonable.  See id. § 488.438(e)(3), (f); North Las Vegas Care Ctr., DAB No. 2946, at 2 (2019).  However, a SNF may not contest CMS’s finding about the “level of noncompliance” (e.g., a finding of immediate jeopardy) except in limited circumstances, such as when a successful challenge would affect the range of CMP amounts that CMS may impose.  42 C.F.R. § 498.3(b)(14).

Here, Petitioner failed to argue that any of the other factors support a reduction of the CMP amount. Because of the 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 the civil money penalty amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).  On that basis, I conclude that the CMP amount is reasonable.

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VI.     CONCLUSION

I find that the Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)–(2) (Tag F689), cited at scope and severity G, and 483.25 (Tag F684), cited at scope and severity D.  The CMP imposed of $1,530 per day for 17 days, for a total of $26,010, is reasonable.  Due to the total penalty amount, Petitioner is barred from offering a Nurse Aide Training and Competency Evaluation Program (NATCEP).