Victoria Care Center, DAB CR5839 (2021)

DECISION

Petitioner, Victoria Care Center (“the facility”), challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with the Medicare program participation requirements.  Petitioner also challenges the imposition of enforcement remedies that included a per-day civil money penalty (CMP) of $505 for 67 days of noncompliance, a denial for payment of new admissions (DPNA) from December 12, 2017, through January 3, 2018, and the withdrawal of its approval to conduct a nurse aid training and competency evaluation program (NATCEP).  For the reasons discussed below, I affirm CMS’s determination.

I.  Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (the Secretary) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. parts 483 and 488.  To participate in the Medicare program, a facility must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, any deficiencies may “pose no greater risk to resident health or safety than the potential for causing

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minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301. 

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 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.  42 U.S.C. § 1395i-3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  Among other enforcement remedies, CMS may impose a per-day CMP for the number of days the SNF is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance.  42 C.F.R. §§ 488.430(a), 488.438(a)(2).  A DPNA may be imposed pursuant to 42 C.F.R. § 488.417(a), and approval for a facility to conduct a NATCEP may be withdrawn pursuant to 42 C.F.R. § 483.151(f)(1).

If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and 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).

The California Department of Public Health (state agency) completed a recertification survey at Petitioner’s facility in Baldwin Park, California, that concluded on October 29, 2017.  CMS Ex. 1 at 1.  CMS imposed a CMP of $505 per day1 for noncompliance with, inter alia, 42 C.F.R. §§ 483.25(d) (Tag F323, cited at the “G” level of scope and severity), 483.24 (Tag F309, cited at the “D” level of scope and severity), and 483.45(d) (Tag F329, cited at the “D” level of scope and severity).2  CMS Exs. 5 at 2; 7 at 1; 8 (revised statement of deficiencies).  CMS also imposed a DPNA from December 12,

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2017, through January 3, 2018, and withdrew approval for Petitioner to conduct a NATCEP.  CMS Exs. 5 at 2-3; 7 at 2.  On February 9, 2018, CMS advised Petitioner that it had returned to substantial compliance, effective January 4, 2018.  CMS Ex. 7 at 2.  

Petitioner timely requested a hearing on January 24, 2018.  CMS filed a pre-hearing brief (CMS Br.) and 30 proposed exhibits (CMS Exs. 1-30), and Petitioner filed a pre‑hearing brief (P. Br.) and 19 proposed exhibits (P. Exs. 1-19).  After this case was reassigned to me on March 8, 2019, the parties filed pre-hearing supplemental briefs (CMS Supp. Br.; P. Supp. Br.). 

In an August 14, 2019 Order, I admitted all exhibits.3  See Tr. at 9.  The parties submitted post-hearing briefs (CMS Post-Hearing Br.; P. Post-Hearing Br.), and post-hearing reply briefs (CMS Reply; P. Reply).  The record is closed, and the matter is ready for a decision on the merits.

II.  Issues

The issues presented are:

1. Whether Petitioner failed to be in substantial compliance with the Medicare program participation requirements at 42 C.F.R. §§ 483.25(d), 483.24, and 483.45(d).
2. If so, whether the enforcement remedies of a per-day CMP of $505 for 67 days, a DPNA from December 12, 2017, through January 3, 2018, and the withdrawal of NATCEP approval, are reasonable.

III.  Discussion4

The evidence supports that Petitioner failed to substantially comply with the requirements of 42 C.F.R. §§ 483.25(d), 483.24, and 483.45(d) when it did not take reasonable steps to protect Resident #2 from a foreseeable accident, did not ensure compliance with a physician order for Resident #3 to receive a registered dietician consultation, and did not adequately monitor Resident #4 to ensure that unnecessary drugs had not been administered.

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1. Petitioner repeatedly documented that Resident #2 required extensive assistance with personal hygiene and wheelchair locomotion, yet its staff left Resident #2 unattended to brush her teeth while seated in her wheelchair, at which time she fell and suffered a forehead laceration that required  debridement and cauterization.  Resident #2 sustained actual harm after Petitioner did not provide adequate supervision to prevent accidents, as required by 42 C.F.R. § 483.25(d).

Resident #2, a woman who was born in 1919, was admitted to the facility in October 2014.  CMS Ex. 21 at 5.  Resident #2’s medical history was significant for osteoarthritis, age-related osteoporosis, and dementia.  CMS Ex. 21 at 11.  

A July 20, 2017 Minimum Data Set (MDS) assessed that Resident #2 had a Brief Interview for Mental Status (BIMS) score of 12.5   CMS Ex. 21 at 19.  The MDS assessed that Resident #2 required as much as extensive assistance with all activities of daily living (ADLs) except for eating (for which she required as much as limited assistance).  CMS Ex. 21 at 20.  In particular, the MDS assessed that Resident #2 required as much as extensive assistance with personal hygiene, to include brushing teeth.  CMS Ex. 21 at 20.  Further, the MDS assessed that Resident #2 required as much as extensive assistance with locomotion on and off the unit, which included consideration of her “self-sufficiency once in [wheel]chair.”  CMS Ex. 21 at 20.  Petitioner reported that it provided as much as a one‑person physical assist for all ADLs during the lookback period.  CMS Ex. 21 at 20.  Petitioner documented that Resident #2 normally used a walker and wheelchair.  CMS Ex. 21 at 20. 

Resident #2 was hospitalized with a chronic obstructive pulmonary disease exacerbation and re-admitted to the facility on October 2, 2017, at which time Petitioner identified her as being at risk for falls due to muscle weakness.  CMS Ex. 21 at 5; P. Ex. 9.  Petitioner completed a “Resident Admission Assessment” of Resident #2 on October 2, 2017, in which it reported that she “Requires 2-Person Assist for ADLs/Mobility.”  CMS Ex. 21 at 38-39.  With respect to “Physical Functioning,” Petitioner reported an “Extensive Assist” was required for bed mobility, transfers, walking, locomotion on unit, locomotion off unit, dressing, toilet use, personal hygiene, and bathing.  Petitioner reported supervision was required for eating.  CMS Ex. 21 at 39.

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An occupational therapy treatment report, dated October 2, 2017, reported that Resident #2 had a decline in feeding and dressing skills related to decreased activity tolerance and decreased upper extremity strength/coordination secondary to an unspecified medical condition listed as “other.”  CMS Ex. 21 at 36.  The form reported unspecified “Fall Risk” precautions.  CMS Ex. 21 at 36.  Goals included improving Resident #2’s performance of the “ADL skills” of feeding and dressing so that she would require only a standby level of assistance and to similarly improve her “ADL transfers” so that only a standby level of assistance was necessary.  CMS Ex. 21 at 36.  The record reported that Resident #2 would receive four weeks of occupational treatment for “Self Care/ADL’s,” “Therapeutic Exercises,” and “Neuromuscular Re-Education.”  CMS Ex. 21 at 36.

An October 3, 2017 resident care plan listed the following under the heading of “Concerns & Problems”:

High risk for fall/injuries due to gait imbalance
Needs assist with ADLs
Cognitive impairment
Hypertension meds
Recent weight loss
Arthritis
Coronary artery disease
Osteoporosis at risk for unexplainable fracture
Recent hospitalization/COPD.

CMS Ex. 21 at 32.  The care plan reported that the “Resident Goal” was to “implement safety interventions to minimize injury potential.”  CMS Ex. 21 at 32.  An “Approach Plan” included monitoring for adverse medication effects, avoiding sudden position changes, explaining procedures to gain cooperation, keeping personal items accessible, providing a low bed, handling gently when “moving resident,” and reporting any signs or symptoms of fracture.  CMS Ex. 21 at 32. 

Another resident care plan, also dated October 3, 2017, reported under the heading of “Concerns & Problems” that Resident #2 had a self-care deficit due to physical disabilities and an unspecified medical condition.  CMS Ex. 21 at 34.  The care plan  reported the following, under the “Concerns & Problems” heading:  

Ext[ensive] Assist in Bed Mobility 
Ext[ensive] Assist in Transfer
Ext[ensive] Assist in Walking
Ext[ensive] Assist in [Wheelchair] Locomotion
Ext[ensive] Assist in dressing
Limited Assist in eating
Ext[ensive] Assist in toilet use

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Ext[ensive] Assist in personal hygiene
Ext[ensive] Assist in Bathing. 

CMS Ex. 21 at 34.  Each of these ADLs was pre-printed on the care plan document and preceded by a blank field on which Petitioner included a handwritten notation for the necessary level of assistance (e.g., “_____ Assist in Walking”).  CMS Ex. 21 at 34.  The document listed a “Resident Goal” that Resident #2 “will be free from body odor, clean and dressed appropriately daily.”  CMS Ex. 21 at 34.  The “Approach Plan” included the following interventions that were selected from a pre-printed list of potential interventions:  assessing and observing level of safety awareness and judgment; maintaining visual check when up in wheelchair and when in bed when necessary; encouraging Resident #2 to participate in ADLs; and assisting with ADLs as needed.6   CMS Ex. 21 at 34.

An October 5, 2017 MDS assessed that Resident #2 had a BIMS score of 10.  P. Ex. 5 at 6; see n.4, supra.  The MDS reported that Resident #2 required as much as extensive assistance with bed mobility, transfers, dressing, toilet use, and personal hygiene, and as much as limited assistance with eating.  P. Ex. 5 at 11.  Other activities, to include walking in her room and in the corridor, did not occur during the lookback period.  P. Ex. 5 at 11.  Petitioner also reported that locomotion on and off the unit, to include in a wheelchair, “did occur but only once or twice” and that staff provided as much as a one‑person physical assist for locomotion.  P. Ex. 5 at 11.  Petitioner reported that when it assessed Resident #2’s ability to propel her wheelchair 50 feet with two turns, it provided partial/moderate assistance to lift, hold or support trunk or limbs, providing “less than half the effort,” “because resident’s performance is unsafe or of poor quality.”  P. Ex. 5 at 16.   

Petitioner conducted another MDS assessment on October 20, 2017.  Petitioner assessed that Resident #2 had a BIMS score of 10, and the report of her self-performance of ADLs and the level of assistance provided for those ADLs mirrored the July 20 and October 5, 2017 assessments.  CMS Ex. 21 at 7, 9.  In particular, Resident #2 continued to require as much as extensive assistance with personal hygiene and wheelchair locomotion.  CMS Ex. 21 at 9.

On October 20, 2017, a facility nurse entered the following information in a 6:00 am nursing note:

Resident alert and verbally responsive [with] periods of confusion.  Reality orientation provided . . . .  Resident

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requires extensive assist [with] most ADLs such as grooming, baths, toileting, personal hygiene and transfers.

CMS Ex. 21 at 28.  A 10:00 pm nursing note, also entered on October 20, 2017, similarly reported that Resident #2 “needs extensive assist on ADLs like grooming [and] hygiene.”  CMS Ex. 21 at 28-29.  Likewise, the following day, on October 21, 2017, a nurse again documented that Resident #2 “requires extensive [sic] [with] most ADLs, such as grooming, bathing, toileting, transfer, and personal hygiene.”  CMS Ex. 21 at 29. 

Resident #2 fell from her wheelchair on October 20, 2017, as documented by a 1:00 pm nursing note reporting that she “was found lying on the floor in a supine position.”  CMS Ex. 21 at 28.  A physical assessment revealed a “skin tear” to Resident #2’s forehead, with deep purple swelling to the surrounding skin but with “minimal bleeding” and swelling.  CMS Ex. 21 at 28.  A nursing note entered one hour later documented that a wound consultant had cauterized the wound.  CMS Ex. 21 at 28; see P. Ex. 15 (statement of Kenny Chang, PA-C and Bardia Anvar, MD that the wound was not bleeding at the time of cauterization, but that the wound had been cauterized to resolve bleeding caused by debridement of the wound); see P. Ex. 11 (statement of Lorna Tangian, RN).  That same day, Resident #2’s physician assessed that she had a laceration to the left side of her forehead and ordered topical antibiotic ointment and dressing changes daily for 14 days.  P. Exs. 13, 14.  Treatment records document that three weeks later, on November 10, 2017, the wound had not fully healed.  P. Ex. 10 at 2 (reporting serous drainage from the wound).

An October 20, 2017 “IDT Accident/Incident Review” form documents the following: 

On 10/20/2017, Resident fell from her [wheelchair].  Based on investigation, her CNA assisted her to the [bathroom] to brush her teeth [and] left her [with] instruction to call when she is finished (her regular routine) but that day, [Resident #2] did not call.  According to [Resident #2], her wheelchair got stuck [at] the bedroom door on her way out.  She said she tried her best to [illegible] her wheelchair out but she fell forward.

P. Ex. 9.  An “Interview Record” reports that the CNA informed the interviewer that “she helped [Resident #2] pushed [sic] her [wheelchair] inside the [bathroom] to brush her teeth, but when she turn[ed] around to get a towel she heard a thump [and] saw patient lying sideways on the floor.”  P. Ex. 6 at 1.  A subsequent interview of the CNA on October 30, 2017, revealed that she had an established routine in which she would push Resident #2 to her bathroom, hand her a toothbrush, toothpaste, and a towel, leave her in her wheelchair, and direct her to use the call light when she finished brushing her teeth.  P. Ex. 8.  The CNA reported, at the time of Resident #2’s fall, that she was approximately

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12 feet away in Resident #2’s room and retrieving a towel.  P. Ex. 8.  The CNA reported that Resident #2 “tried to wheel herself out of the [bathroom]” and “her wheelchair got stuck in the doorway [and she] slipped from the [wheelchair].”  P. Ex. 8.  The CNA reported that “she tried to get to [Resident #2] but [was] unsuccessful.”7   P. Ex. 8.

Subsection 483.25(d) is part of the quality of care regulation at 42 C.F.R. § 483.25, which states that “[q]uality of care is a fundamental principle that applies to all treatment and care provided to facility residents.”  Subsection 483.25(d) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:

The facility must ensure 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)(1)-(2).

The Departmental Appeals Board (DAB) has held that subsection 483.25(d)(1)8 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)); see The Bridge at Rockwood, DAB No. 2954 at 10 (2019)(“The correct question is whether the facility did what it reasonably could to ensure that all residents received supervision needed to ‘mitigate foreseeable risks of harm’ based on what it knew about the residents, their care needs, and the conditions in the facility.”).  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 & Human Servs., 604 F.3d 445 (7th Cir. 2010).  The DAB has held that 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.”

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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). 

As previously discussed, Petitioner repeatedly recognized that Resident #2 required extensive assistance with most ADLs, to include personal hygiene and locomotion in her wheelchair.  Petitioner had also assessed that Resident #2 had moderate cognitive impairment and had periods of confusion.  See CMS Ex. 21 at 7, 28; P. Ex. 5 at 6.  Petitioner distorts Resident #2’s care plan, arguing that it had not determined that Resident #2 should be provided extensive assistance with most ADLs, to include personal hygiene and wheelchair locomotion.  See P. Post-Hrg. Br. at 4-6.  No reasonable reading of the care plan could yield any interpretation other than that Petitioner had determined that Resident #2 required extensive assistance with all ADLs, with the exception of eating.  See CMS Ex. 21 at 34 (listing a “Concern & Problem” that Resident #2 required extensive assistance with personal hygiene and wheelchair locomotion).

In addition to the care plan that listed a “Concern & Problem” of Resident #2’s need for extensive assistance with numerous ADLs, a significant amount of evidence supports that Petitioner and its nursing staff, with the exception of the CNA who left Resident #2 unattended on October 20, 2027, knew and repeatedly documented that Resident #2 required extensive assistance with most ADLs, as evidenced by the following:

• July 2017 MDS assessing that Resident #2 required as much as extensive assistance with wheelchair locomotion (to include self-sufficiency in a wheelchair) and personal hygiene (to include brushing teeth).  CMS Ex. 21 at 20. 
• October 2, 2017 re-admission assessment reporting that Resident #2 needed extensive assistance with ADLs except for eating.  CMS Ex. 21 at 39.
• October 5, 2017 MDS assessing that Petitioner provided as much as a one‑person physical assist with wheelchair locomotion (to include self‑sufficiency in a wheelchair) and that Petitioner provided partial/moderate assistance to lift, hold, or support trunk or limbs because Resident #2’s self-performance of wheeling a chair 50 feet with two turns was “unsafe or of poor quality.”  P. Ex. 5 at 11, 16.
• October 5, 2017 MDS assessing that Resident #2 required as much as extensive assistance with personal hygiene (to include brushing teeth) and that Petitioner provided as much as a one-person assist with personal hygiene.  P. Ex. 5 at 11.

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• October 20, 2017 MDS assessing that Resident #2 required as much as extensive assistance with wheelchair locomotion (to include self‑sufficiency in a wheelchair) and personal hygiene (to include brushing teeth).  CMS Ex. 21 at 7, 9.
• October 20, 2017 nursing note reporting that Resident #2 had “periods of confusion” and “requires extensive assist [with] most ADLs such as grooming, baths, toileting, personal hygiene and transfers.”  CMS Ex. 21 at 28.
• October 20, 2017 nursing note reporting that Resident #2 “needs extensive assist on ADLs like grooming [and] hygiene.”  CMS Ex. 21 at 29.
• October 21, 2017 nursing note reporting that Resident #2 “requires extensive [sic] [with] most ADLs, such as grooming, bathing, toileting, transfers and personal hygiene.”  CMS Ex. 21 at 29.

Not only did Petitioner care-plan for Resident #2’s need for extensive assistance with nearly all ADLs (CMS Ex. 21 at 34), but it repeatedly reported on her need for extensive assistance with most ADLs.  Further, and quite significantly, several nurses documented, both before and after the October 20, 2017 fall, that Resident #2 should be provided extensive assistance with ADLs; it would be illogical that each of these nurses documented that Resident #2 required extensive assistance with ADLs if the care plan and the resident’s needs did not warrant that level of extensive assistance.   

Petitioner essentially blames a resident with dementia, cognitive impairment, and periods of confusion for her fall, arguing that the fall was unforeseeable because Resident #2 was “alert” and “able to follow” commands and fell when she “wheeled herself out of the bathroom unassisted despite the CNA’s instruction to wait.”  P. Post-Hrg. Br. at 8; see CMS Ex. 21 at 7, 19, 28.  Contrary to this claim, Resident #2 is not to blame for her injury; had Petitioner provided assistance to Resident #2 when she was brushing her teeth, as required by the care plan and recognized as a need by Petitioner and several nurses, it is unlikely Resident #2 would have fallen and sustained a head laceration.  While Petitioner may expect that a cognitively impaired and sometimes-confused resident will always follow instructions, such a strategy cannot be a substitute for the supervision and ADL assistance that has been determined to be necessary to prevent foreseeable accidents.  In fact, the CNA involved in the incident admitted that she routinely did not provide extensive assistance to Resident #2 when she performed personal hygiene, but rather, expected Resident #2 to self-perform this ADL.  See P. Ex. 9 (“Based on investigation, [Resident #2’s] CNA assisted her to the [bathroom] to brush her teeth [and] left her [with] instruction to call when she is finished (her regular routine), but that day, [Resident #2] did not call [and] got stuck [at] the [bathroom] door [and] fell forward.”).

The DAB has recurrently held that section 483.25(d) “obligates a facility to 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.’”

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Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017) (quoting Briarwood, DAB No. 2115 at 5).  The DAB has also explained:

For a risk to be foreseeable, it need not have been made obvious by having already materialized.  The regulation speaks in terms of ensuring that what is “practicable” and “possible” to do is done.  What is thus required of facilities is not prescience but reason and professional judgment in assessing what can be done to make residents (given their special needs) safe, through removing accident hazards, providing appropriate devices, and ensuring adequate supervision.

Josephine Sunset Home, DAB No. 1908 at 15 (2004).  It is well-documented that Resident #2 required extensive assistance with ADLs.  Petitioner admits that that it left Resident #2 alone in her wheelchair to perform personal hygiene, and as a result, Resident #2 fell out of her wheelchair and sustained an injury.  Petitioner did not provide the supervision necessary to prevent Resident #2’s accident, and it therefore failed to comply with 42 C.F.R. § 483.25(d).

2. On October 6, 2017, a physician ordered a registered dietician consultation for Resident #3.  Because Resident #3 did not receive this consultation until three weeks later on October 27, 2017, even though a dietician typically visited the facility on a weekly basis, Petitioner failed to comply with a physician order, as required by 42 C.F.R. § 483.24.

Resident #3, a man born in 1923, had a medical history significant for Type 2 Diabetes Mellitus, infection of an amputation stump, and peripheral vascular disease.  CMS Ex. 22 at 1, 5.  On October 6, 2017, Resident #3’s physician ordered that he receive a registered dietician evaluation because laboratory testing had revealed that he had a decreased albumin level.  CMS Ex. 22 at 18.  However, Resident #3 did not receive a registered dietician consultation until October 27, 2017, at which time the survey was in progress.  CMS Exs. 1 at 3-6; 29 at 4; see CMS Br. at 11.  When questioned, a facility nurse acknowledged that a registered dietician visited the facility on Mondays, but could not explain why the registered dietician did not evaluate Resident #3 on any of the preceding Mondays (October 9, 16, and 23, 2017).  CMS Ex. 29 at 4; see CMS Ex. 1 at 6.  Petitioner has not alleged, nor offered evidence to show, that it arranged for the registered dietician consultation prior to the state agency’s identification of this issue. 

Petitioner has a policy for notifying a consultant dietician of an assessment request.  CMS Ex. 18 at 25.  Pursuant to the policy, a licensed nurse completes a communication form and sends it to the dietary service supervisor, who in turn informs the registered dietician

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of the specific residents who have been referred for a dietary consultation.  CMS Ex. 18 at 25.

Pursuant to 42 C.F.R. § 483.24, which implements section 1819(b)(2) of the Act, “[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident’s comprehensive assessment and plan of care.”  Additionally, 42 C.F.R. § 483.25 requires that a 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 . . . .”  The quality of care legislation and regulatory requirements are “based on the premise that the facility has (or can contract for) the expertise to first assess what each resident’s needs are (in order to attain or maintain the resident’s highest practicable functional level) and then to plan for and provide care and services to meet the goal.”  Spring Meadows Health Care Ctr., DAB No. 1966 at 16 (2005).  The regulation thus “imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree.”  Windsor Health Care Ctr., DAB No. 1902 at 16-17.  The facility must take reasonable steps and all practicable measures to achieve that regulatory end.  Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 21 (2004), aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x 900 (6th Cir. 2005). 

The DAB has concluded that the quality of care regulation9 requires skilled nursing facilities to furnish the care and services set forth in a resident’s care plan and to implement doctors’ orders, monitor and document the resident’s condition, and follow its own policies.  See, e.g., Alexandria Place, DAB No. 2245 at 7-8 (2009) (upholding a deficiency when a petitioner did not provide care in accordance with a doctor’s order); Oxford Manor, DAB No. 2167 at 5-6 (2008) (affirming an ALJ’s reliance on a facility’s policy as evidence of the standard of care the facility expected its staff to provide).  The quality of care provision also implicitly imposes on facilities a duty to provide care and services that, at a minimum, meet accepted professional standards of quality “since the regulations elsewhere require that the services provided or arranged by the facility must meet such standards.”  Spring Meadows, DAB No. 1966 at 17 (citing42 C.F.R. § 483.25).

Resident #3 did not receive a registered dietician consultation until October 27, 2017, which was during the course of the survey, even though the registered dietician typically visited the facility every Monday and three Mondays had passed since the physician ordered the consultation on Friday, October 6, 2017.  CMS Ex. 29 at 4.  Rather than

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submitting evidence that it had either scheduled this consultation or had taken steps, in compliance with its policy, to schedule this consultation prior to October 27, 2017, Petitioner offers unsupported speculation that the surveyors “ignore[d] the possibility that exigent circumstances existed, which prevented the [registered dietician] from performing the evaluation sooner than October 27, 2017.”  P. Br. at 11.  Even if such exigent circumstances existed, which Petitioner has neither explained nor submitted evidence to show, Petitioner has not alleged that its nursing staff actually submitted a communication form to the dietary service supervisor so that the registered dietician could be notified of the request for a consultation.  See CMS Exs. 1 at 6; 8 at 6; 18 at 25.  Petitioner failed to provide the necessary care and services for Resident #3, a diabetic resident with abnormal laboratory testing who was in need of a dietary consultation, to maintain the highest practicable physical, mental, and psychosocial well-being, as required by 42 C.F.R. § 483.24.

3. Petitioner was unaware that Resident #4, who was taking an antipsychotic medication, had bilateral hand tremors until a surveyor brought it to the attention of a facility nurse.  Because Petitioner did not adequately monitor Resident #4 while she was prescribed an antipsychotic medication, Petitioner did not comply with 42 C.F.R. § 483.45(d).10

Resident #4, a woman born in 1946, had been a resident of the facility since May 2000.  CMS Ex. 23 at 5.  Resident #4’s diagnoses included schizophrenia and major depressive disorder, and she was prescribed Risperdal, an antipsychotic medication.  CMS Ex. 23 at 5, 16.  A May 10, 2017 physician order directed that Resident #4 be monitored for “Parkinsonism (tremors, drooling, rigidity),” but her May 2017 psychotropic medication care plan lacked any guidance for staff to monitor for parkinsonism symptoms.11   CMS Ex. 23 at 16, 24.  A “Behavior/Psychotropic Meds” care plan for the risk for adverse side effects from medication use had a goal of Resident #4 being free from medication side effects12 and included an approach that staff monitor adverse side effects of medications every shift and notify the physician if any adverse side effects were noted.  CMS Ex. 23 at 23.  A “Psychopharmaceutical Summary Sheet” for Risperdal reported an absence of adverse reactions between May and September 2017.  CMS Ex. 23 at 19.

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The statement of deficiencies reports that a surveyor observed, at 8:00 pm on October 27, 2017, that Resident #4 had bilateral hand tremors.  CMS Ex. 8 at 14.  When questioned by a surveyor, Resident #4 reported that she could not recall when her tremors started.13   CMS Ex. 8 at 14.  The surveyor again observed Resident #4’s bilateral hand tremors at 9:00 am the following morning, at which time she identified the tremors to a facility nurse, who acknowledged that “tremors are adverse reactions from the use of psychotropic medications” that warranted immediate physician notification.  CMS Ex. 8 at 14-15; see CMS Ex. 29 at 5 (surveyor testimony).  Facility records submitted by CMS  lack any documentation of hand tremors, and Petitioner has not submitted any evidence that it documented tremors.  See CMS Ex. 23. 

Petitioner has a psychoactive medication guidelines policy that directs that facility staff “will monitor the resident’s medical symptoms, condition, circumstances and environment in order to evaluate the appropriate use of the psychoactive medication.”  CMS Ex. 18 at 10.  The policy also requires designated facility staff to “monitor for side effects” and to document “the presence or absence of side effects.”  CMS Ex. 18 at 10.  The policy instructs that “unnecessary drugs” are any drugs when used in such circumstances as “[w]ithout adequate monitoring” and when “adverse consequences . . . indicate the dose should be reduced or discontinued.”  CMS Ex. 18 at 11.

Pursuant to 42 C.F.R. § 483.45(d), a resident’s drug regimen must be free of any unnecessary drugs, which include drugs that are used without adequate monitoring or in the presence of adverse consequences which indicate the dose should be reduced or discontinued.  42 C.F.R. § 483.45(d)(3), (5).  Petitioner posits that Resident #4, apparently for the very first time, developed hand tremors during the course of the survey.  P. Br. at 13-14.  Resident #4 also reported that she could not recall when her hand tremors began, evidencing a more remote onset than that same day.  CMS Ex. 8 at 14.  Further, Resident #4’s care plan lacked any guidance for staff members to monitor her for parkinsonism, even though a previous care plan required such monitoring and the physician directed Petitioner to monitor for these symptoms.  CMS Ex. 23 at 16, 23-25. Petitioner argues that “[t]he ability of [the nurse] to correctly identify Resident 4’s hand tremors as being an adverse reaction to her psychotropic medication lends support to the notion that if such behavior had manifested prior to the survey, it would have been documented and immediately reported.”  P. Br. at 14.  Petitioner is mistaken; the evidence supports that Petitioner did not adequately monitor Resident #4 while she was taking an antipsychotic medication, in that it neither observed nor documented a potential adverse consequence that was visible not only to a surveyor but also a facility nurse.  Petitioner failed to comply with the requirements of 42 C.F.R. § 483.45(d).

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4. Petitioner did not correct several unappealed deficiencies until January 4, 2018, and it therefore remained out of compliance through and inclusive of January 3, 2018.

Petitioner does not dispute that it returned to substantial compliance on January 4, 2018.  See Request for Hearing; P. Br.; P. Supp. Br.; P. Post-Hrg. Br.; P. Reply Br.  Once a facility is found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Premier Living & Rehab Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care Ctr., DAB No. 1658 at 12-15 (1998).  The burden is on the facility to prove that it is compliant with program requirements and not on CMS to prove that deficiencies continued to exist after they were discovered.  Asbury Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002); see also Grace Living Ctr. – Northwest OKC, DAB No. 2633 at 3 (2015) (citing Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011)).  Noncompliance found during a survey is “presumed to continue until the facility demonstrates it has achieved substantial compliance.”  Taos Living Ctr., DAB No. 2293 at 20 (2009).  

Petitioner limited its request for hearing to the deficiencies addressed herein, and it did not appeal the following deficiencies cited at the “D” level of scope and severity or higher, which a revisit survey determined had been corrected on January 4, 2018:  42 C.F.R. §§ 483.12 (Tag F225); 483.45(b)(2)-(3), (g), (h) (Tag F431); 483.80(a), (e), (f) (Tag F441); 483.90(d)(2), (e) (Tag F456); 483.75(m)(2) (Tag F518); and 483.90(g)(2) (Tag F463).  CMS Exs. 6, 8.  Because these deficiencies are administratively final, Petitioner remained out of substantial compliance until January 4, 2018.  CMS Exs. 6; 7 at 1-2.

5. Petitioner does not provide any basis to dispute the enforcement remedies imposed, and a per-day CMP of $505, a DPNA, and the withdrawal of NATCEP approval are reasonable enforcement remedies.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  In determining whether the CMP imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f).  42 C.F.R. 488.438(e)(3).  These factors include:  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.  42 C.F.R. § 488.438(f).  The absence of culpability is not a mitigating factor.  Id.  The factors 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.

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CMS may impose a discretionary DPNA any time a facility is not in substantial compliance with Medicare participation requirements.  42 C.F.R. § 488.417(a).  When a facility does not have repeated instances of substandard quality of care, payments resume when the facility achieves substantial compliance.  Act § 1819(h)(3) (42 U.S.C. § 1395i‑3(h)(3)); 42 C.F.R. § 488.417(d).  CMS imposed a DPNA beginning December 12, 2017, and the DPNA continued until Petitioner returned to substantial compliance on January 4, 2018.  CMS Exs. 5 at 2; 7 at 2.  Petitioner neither argues that CMS lacked a legal basis to impose a DPNA nor that it returned to compliance prior to January 4, 2018.  CMS had a legitimate basis to impose a DPNA from December 12, 2017, until Petitioner returned to compliance on January 4, 2018.

CMS also notified Petitioner of the withdrawal of approval for it to conduct a NATCEP based on the imposition of enforcement remedies that included a DPNA and CMP.  CMS Ex. 5 at 3; see 42 U.S.C. § 1395i-3(f)(2)(B)(iii)(I)(c); 42 C.F.R. § 483.151(f)(1).  Because a DPNA was imposed and the CMP exceeded the inflation-adjusted monetary threshold of $5,000, as will be discussed below, withdrawal of NATCEP approval is mandated by law.  See 42 C.F.R. § 483.151(b)(2)(iv), (v).

CMS also imposed a per-day CMP of $505 for the 67 days of noncompliance.  The DAB has explained that “it is settled law that ALJ review of the reasonableness of CMP amounts imposed by CMS is de novo.”  Fireside Lodge Retirement Ctr., Inc., DAB No. 2794 at 19 (2017).  I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the above factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).  The DAB has stated that “[t]he determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact.”  Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010).  

The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges.  42 C.F.R. §§ 488.408, 488.438.  The lower CMP range of $50 to $3,000 per day, as adjusted annually under 45 C.F.R. part 102, is applicable here.14   42 C.F.R. § 488.438(a)(1)(ii).  In assessing the reasonableness of a CMP, an ALJ

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looks at the per-day amount, rather than the total accrued CMP.  See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008).  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(a)-(c).  See, e.g., Senior Rehab. and Skilled Nursing Ctr., DAB No. 2300 at 19-20 (2010), aff’d,405 F. App’x 820 (5th Cir. 2010). 

The per‑day CMP of $505 is at the very low end of the CMP range of $105 to $6,289 range applicable at that time for deficiencies that did not constitute immediate jeopardy.  See 45 C.F.R. § 102.3 (2018); 82 Fed. Reg. at 9182-83.  Petitioner has not argued that any of the enumerated regulatory factors warrant a reduction of the per-day CMP, and it has not cited any regulatory basis to challenge the reasonableness of the per-day CMP.

The per-day CMP of $505 is not unreasonably high considering the number of deficiencies and that a resident was harmed as a result of one of the deficiencies.  See 42 C.F.R. § 488.438(f)(3), (4).  A per-day CMP of $505 at the very low end of the CMP range, for a total CMP of $33,835, is therefore reasonable pursuant to 42 C.F.R. § 488.438(f); if anything, the CMP may be too low to ensure prompt compliance with participation requirements.  

IV.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with Medicare participation requirements.  A DPNA, withdrawal of NATCEP approval, and a per-day CMP of $505 are reasonable enforcement remedies.

1. In an August 6, 2018 joint filing, the parties mutually agreed that the citation for three specific deficiencies is “presented for hearing.”  See August 14, 2019 Order Summarizing Pre-Hearing Conference; Transcript (Tr.) at 9.
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2. Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  Pub. 100-7, State Operations Manual (SOM), chap. 7, § 7400.5.1 (Factors That Must be Considered When Selecting Remedies), “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table) (Rev. 161, eff. Sept. 28, 2016 (applicable at the time of the survey at issue)); see SOM, chap. 7, § 7400.3.1 (Rev. 185, eff. Nov. 16, 2018) (current version); see also 42 C.F.R. § 488.408.  A scope and severity level of G indicates an isolated deficiency that involves actual harm that does not amount to immediate jeopardy to resident health and safety, and a scope and severity level of D indicates an isolated deficiency, without actual harm, that poses a potential for more than minimal harm.
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3. I had provisionally admitted CMS Exs. 29 and 30 (written direct testimony of the state agency surveyors).  Because the surveyors appeared for cross-examination at the September 23, 2019 hearing, all proposed exhibits are admitted into the evidentiary record.
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4. Findings of fact and conclusions of law are in bold and italics.
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5. A BIMS score of 8-12 indicates that the subject’s cognition is “moderately impaired.”  See Long‑Term Care Facility Resident Assessment Instrument (RAI) 3.0 User’s Manual, Ch. 3 (Overview to the Item-by-Item Guide to the MDS 3.0), § C0500 (Summary Score) at C-14, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/MDS-30-RAI-Manual-V113.pdf (last visited March 22, 2021).
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6. The options not selected from the pre-printed list of interventions included maintaining a clutter-free environment, assist in use of bed pan, “task segmentation as needed to task resident needs assistance with,” and apply device in bed as needed.  CMS Ex. 21 at 34.
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7. This account appears to be inconsistent with the initial nursing note reporting that Resident #2 was “found lying on the floor.”  CMS Ex. 21 at 28.
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8. The DAB referenced section 483.25(h)(1); that section was re-designated as section 483.25(d)(1) pursuant to regulatory revisions that became effective November 28, 2016.  81 Fed. Reg. 68,688 (Oct. 4, 2016).
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9. Federal nursing home regulations substantially changed beginning on November 28, 2016.  81 Fed. Reg. 68,688 (Oct. 4, 2016).  Due to the revisions in the nursing home regulations, the provisions the DAB referenced in 42 C.F.R. § 483.25 are now found in 42 C.F.R. § 483.24.
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10. I focus on just one of the bases for noncompliance with 42 C.F.R. § 483.45(d) cited by CMS.
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11. A previous care plan that was discontinued in November 2016 addressed monitoring for parkinsonism.  CMS Ex. 23 at 25.
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12. The care plan did not list known adverse side effects.  CMS Ex. 23 at 23.
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13. Based on a June 2017 BIMS assessment of 15/15, the evidence indicates that Resident #4 is cognitively intact.  CMS Ex. 23 at 7.
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14. The cost-of-living adjustment was mandated pursuant to the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, 104 Pub. L. No. 114-74, § 701, which was enacted on November 2, 2015.  The inflation-adjusted CMPs are applicable, as the survey was completed on October 29, 2017, and the CMP was imposed on November 27, 2017.  The per-day CMP ranges applicable to this case are $105 to $6,289 for deficiencies that do not constitute immediate jeopardy. 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017); see 82 Fed. Reg. at 9174-75 (“The adjusted civil penalty amounts apply to civil penalties assessed on or after February 3, 2017, when the violation occurred after November 2, 2015.”).  But see CMS Br. at 11 (“[T]he CMP was $505 per day, and a penalty between $50 and $3,000 can be imposed when there is no immediate jeopardy but the deficiencies either caused actual harm or have the potential for more than minimal harm.”).
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