Heritage Park Rehabilitation & Healthcare, DAB CR5194 (2018)

DECISION

Heritage Park Rehabilitation & Healthcare (Petitioner or the facility), a skilled nursing facility (SNF) located in Fort Myers, Florida, challenges the Centers for Medicare & Medicaid Services’ (CMS’s) determination that the facility was not in substantial compliance with multiple Medicare program participation requirements from January 12, 2015 through March 12, 2015. Petitioner also challenges CMS’s imposition of a civil money penalty (CMP) of $1,500 per day for 60 days of noncompliance. For the reasons discussed below, I find that Petitioner failed to comply substantially with several participation requirements. I also conclude that the amount of the CMP imposed, $90,000, is reasonable.

I. Background and Procedural History

On February 13, 2015, surveyors from the Florida Agency for Health Care Administration (state agency) completed concurrent complaint and recertification surveys of Petitioner’s facility.1 CMS Exs. 1 and 2. Based on the survey findings, the state agency concluded that Petitioner was not in substantial compliance with the following Medicare participation requirements:

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• 42 C.F.R. § 483.20(b)(1)2 (Tag F272 – resident assessments), at a scope and severity level of “G”;3
• 42 C.F.R. § 483.25(h) (Tag F323 – accidents), scope and severity “G”;
• 42 C.F.R. § 483.30(a) (Tag F353 – sufficient nursing staff), scope and severity “F”;4
• 42 C.F.R. § 483.10(f)(1) (Tag F165 – resident rights), scope and severity “D”;
• 42 C.F.R. § 483.13(c) (Tag F224 – staff treatment of residents), scope and severity “G”;
• 42 C.F.R. § 483.15(a) (Tag F241 – quality of life, dignity), scope and severity “G”;
• 42 C.F.R. § 483.15(c)(6) (Tag F244 – response to resident/family grievances), scope and severity “D”;

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• 42 C.F.R. § 483.15(h)(2) (Tag F253 – quality of life, environment), scope and severity “E”;
• 42 C.F.R. § 483.35(d)(1)-(2) (Tag F364 – palatability and appearance of food), scope and severity “E”; and
• 42 C.F.R. § 483.35(i) (Tag F371 – food preparation, sanitary conditions), scope and severity “F”.

CMS Exs. 1 and 2.

CMS concurred with the state agency’s determination and notified Petitioner that CMS was imposing, inter alia, a CMP of $1,500 per day “immediately based upon the findings of a Scope/Severity at ‘G’ for F224, F241, F272 and F323.” CMS Ex. 8 at 1, 2. The state agency conducted a revisit of Petitioner’s facility on March 25 and 26, 2015. Based on the findings at the revisit survey, CMS determined that Petitioner achieved substantial compliance with program requirements as of March 13, 2015. CMS Ex. 9. CMS removed the other remedies and imposed only the CMP. Id.

By letter dated March 25, 2015, Petitioner requested Independent Informal Dispute Resolution (IIDR) for the alleged deficiencies. P. Ex. 1. The IIDR Panel recommended that CMS delete Tags F224, F241, F272, and F323. P. Ex. 3 at 1. CMS did not agree with the recommendation. Id.  Instead, in a letter dated June 30, 2015, CMS informed Petitioner that the previously-imposed remedies would remain in effect. P. Ex. 3 at 2.

Petitioner timely requested a hearing before an administrative law judge. On June 15, 2015, Administrative Law Judge Scott Anderson issued an acknowledgment and prehearing order establishing a schedule for exchanging evidence and argument in preparation for a hearing. In accordance with the schedule Judge Anderson set, CMS and Petitioner filed prehearing briefs (CMS Br. and P. Br., respectively), exhibit and witness lists, and proposed exhibits. CMS submitted 35 proposed exhibits (CMS Exs. 1-35), and Petitioner submitted 25 proposed exhibits (P. Exs. 1-25). CMS did not object to any of Petitioner’s proposed exhibits. Petitioner objected to CMS Exs. 1-3, 17, 24-29, 31, 33, 34, and 35 on grounds that the exhibits contained uncorroborated hearsay. Petitioner also objected to CMS Exs. 3, 16, 22, and 32 on grounds that the exhibits are irrelevant.5

Effective October 14, 2016, the case was reassigned to me. On February 15, 2017, I convened a telephone prehearing conference to rule on Petitioner’s objections to CMS’s exhibits and to schedule the case for a hearing. During the conference, CMS agreed to withdraw CMS Exs. 3 and 16. Additionally, the parties jointly requested additional time

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to confer about whether to submit the case for decision on the written record. Following the pre-hearing conference, the parties agreed to submit the case for decision on the written record. I confirmed the parties’ agreement, as well as the matters discussed at the prehearing conference, in an Order Summarizing Prehearing Conference and Establishing Briefing Schedule, dated March 2, 2017 (Briefing Order). In the Briefing Order, I noted that Petitioner waived its hearsay objections to the admissibility of CMS’s exhibits; accordingly, I construed the hearsay objections as withdrawn. Briefing Order at 2. I further noted that the parties stipulated to the admissibility of CMS Ex. 32 for the limited purpose of identifying the residents and staff members involved in the survey. Id. Finally, I set a schedule for the parties to submit closing briefs (P. Closing Br.; CMS Closing Br., P. Reply). Id. Neither party objected to the contents of the Briefing Order.

In its closing brief, Petitioner reiterates its hearsay objections to statements made by Residents 33 and 43. P. Closing Br. at 14 n.7 and 16 n.9. However, as described above, Petitioner withdrew its hearsay objections. Moreover, even if Petitioner had not withdrawn its objections, I would overrule them.6 I may consider any evidence that is relevant and material, even evidence, such as hearsay, that would be inadmissible under the Federal Rules of Evidence. 42 C.F.R. § 498.61 (“Evidence may be received at the hearing even though inadmissible under the rules of evidence applicable to court procedure.”); 42 C.F.R. § 498.60(b)(3) (“The ALJ inquires fully into all of the matters at issue, and receives in evidence the testimony of witnesses and any documents that are relevant and material.”). Therefore, I admit into evidence CMS Exs. 1, 2, 4-15, and 17‑35. I admit Petitioner’s Exs. 1-25 without objection.

II. Issues

A. Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.13(c) (Tag F224), 483.15(a) (Tag F241), 483.20(b)(1) (Tag F272), and 483.25(h) (Tag F323).

B. If Petitioner was not in substantial compliance with Medicare participation requirements, whether the CMP of $1,500 per day for 60 days (a total of $90,000) is reasonable.

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As an initial matter, Petitioner is not entitled to review of CMS’s determination that it was not in substantial compliance with 42 C.F.R. §§ 483.10(f)(1), 483.15(c)(6), 483.15(h)(2), 483.30(a), 483.35(d)(1)-(2), and 483.35(i) (Tags F165, F244, F253, F353, F364, and F371). A SNF has a right to a hearing before an administrative law judge when CMS has “made an adverse ‘initial determination’ of a kind specified in 42 C.F.R. § 498.3(b)”; however, it is only after CMS makes a finding that a SNF is noncompliant and imposes a remedy under 42 C.F.R. § 488.406, that the SNF has received an initial determination subject to further review. Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 6 (2010), dism. on other grounds, Columbus Park Nursing & Rehab. Ctr. v. Sebelius, 940 F. Supp. 2d 805 (N.D. Ill. 2013); see also 42 C.F.R. §§ 488.406; 498.3(b). A SNF “has no right to an [administrative law judge] hearing to contest survey deficiency findings where CMS has not imposed any of the remedies specified in section 488.406 based on those findings . . . .” Columbus Park, DAB No. 2316 at 7. The remedy, not the citation of a deficiency, triggers the right to a hearing. Schowalter Villa, DAB No. 1688 (1999); Arcadia Acres, Inc., DAB No. 1607 (1997). Where CMS does not impose a remedy, Petitioner has no hearing right. See Fountain Lake Health & Rehab., Inc., DAB No. 1985 (2005).

Although CMS and Petitioner both present arguments as to whether Petitioner was in substantial compliance with various deficiencies identified by CMS following the surveys, CMS ultimately only imposed remedies based on deficiencies cited under 42 C.F.R. §§ 483.13(c), 483.15(a), 483.20(b)(1), and 483.25(h). CMS Exs. 8, 9. CMS imposed a CMP of $1,500 per day, “based upon the findings of a Scope/Severity at ‘G’ for F224, F241, F272, and F323.” CMS Ex. 8; see CMS Ex. 9. Therefore, the only initial determinations properly before me are CMS’s findings that Petitioner violated 42 C.F.R. §§ 483.13(c), 483.15(a), 483.20(b)(1), and 483.25(h), because only those instances of alleged noncompliance led to the imposition of enforcement remedies. Petitioner does not have a right to request further review of findings of noncompliance that did not result in the imposition of a remedy. For this reason, Petitioner has no right to administrative law judge review of the findings of noncompliance cited under 42 C.F.R. §§ 483.10(f)(1), 483.15(c)(6), 483.15(h)(2), 483.30(a), 483.35(d)(1)-(2), and 483.35(i) (Tags F165, F244, F253, F353, F364, and F371).

III. Jurisdiction

I have jurisdiction to hear and decide this case. Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

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IV. Discussion

A. Statutory and Regulatory Background

The Act sets requirements for SNFs to participate in the Medicare program and authorizes the Secretary of the United States Department 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. pts. 483 and 488.

To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements. To be in substantial compliance, a SNF’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.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements. Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10. The Act also authorizes the Secretary to impose enforcement remedies against SNFs that do not comply with the participation requirements. Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)). The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance. 42 C.F.R. § 488.406. Among other enforcement remedies, CMS may impose a per-day CMP for the number of days a facility is not in substantial compliance. 42 C.F.R. § 488.430(a). The regulations specify that the CMP will be in the range of $50 - $3,000 per day for deficiencies that do not constitute immediate jeopardy, but either caused actual harm, or caused no actual harm, but have the potential for more than minimal harm.7 42 C.F.R. § 488.438(a)(1)(ii).

If CMS imposes a CMP based on a noncompliance determination, then the facility may request a hearing before an administrative law judge to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable. Act §§ 1128A(c)(2) (42 C.F.R. §1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 C.F.R. § 1395i(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).

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CMS has the burden to come forward with 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 Petitioner bears the ultimate burden of persuasion as to whether it substantially complied. In other words, 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. Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense. Evergreene Nursing Care Ctr., DAB No. 2069 at 7; Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

B. Findings of Fact, Conclusions of Law, and Analysis

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h) (Tag F323) because it did not take all reasonable steps to mitigate the foreseeable risks of harm posed by Resident 94’s history of intoxication and poor safety awareness.8

Subsection 483.25(h) is part of the quality of care regulation at 42 C.F.R. § 483.25, which states that “[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, in accordance with the comprehensive assessment and plan of care.” Subsection 483.25(h) 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.

Appellate panels of the Departmental Appeals Board (DAB) have held that subsection 483.25(h)(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)). Section 483.25(h) places an

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“affirmative duty [on facility staff] to intervene and supervise . . . behaviorally impaired residents in a manner calculated to prevent them from causing harm to themselves and each other.”9 Vandalia Park, DAB No. 1940 at 18 (2004), aff'd, Vandalia Park v. Leavitt, No. 044283 (6th Cir. Dec. 8, 2005), available at http://www.ca6.uscourts.gov/ opinions.pdf/OSa09S7n-06.pdf. 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 under all circumstances.” Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d, Windsor Health Care Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005) (unpublished).

CMS found Petitioner out of compliance with 42 C.F.R. § 483.25(h) following an accident on January 12, 2015, in which Resident 94 was struck by a car while he was outside the facility attempting to cross a highway in his motorized wheelchair. CMS Ex. 22 at 42; see CMS Br. at 3; P. Br. at 6. At the time of the incident, Resident 94 was a 59‑year‑old male who had resided at the facility since September 24, 2012. CMS Ex. 22 at 2-3. Resident 94’s diagnoses included paralysis on one side of his body due to a stroke, muscle weakness, muscle spasms, chronic pain, alcohol dependence, and “[unspecified] drunkenness”. CMS Ex. 22 at 14-15. While Resident 94 had physical limitations, he was otherwise alert with a Brief Interview for Mental Status (BIMS) score of 15, indicating he was not cognitively impaired. CMS Ex. 22 at 6.

Petitioner argues, in essence, that, as a mentally competent adult, Resident 94 had the right to come and go from the facility. P. Br. at 10. Petitioner suggests that placing limits on Resident 94’s ability to use his motorized wheelchair outside the facility would impermissibly constrain his right to “autonomy and choice.” See P. Br. at 10 n.7. Petitioner is correct that facilities must balance their duty of supervision with residents’ rights. See Venetian Gardens, DAB No. 2286 at 18 (2009). However, appellate panels of the DAB have rejected the argument that “if a competent resident exercises his right to leave the facility and place himself in danger, the facility has no responsibilities.” Id. at 21. Rather, facilities have some obligation to protect residents from harm when they temporarily leave the facility. Id. at 22. My evaluation of the record as a whole persuades me that Petitioner did not satisfy its obligations to provide adequate supervision and assistive devices to aid Resident 94 in avoiding accidents. Put another way, even considering Resident 94’s right to exercise autonomy and choice in his day‑to‑day life at Petitioner’s facility, Petitioner did not take all reasonable precautions to keep Resident 94 from causing harm to himself.

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In making this assessment, I give particular weight to the fact that Resident 94 entered Petitioner’s facility with a diagnosis of alcohol dependence. CMS Ex. 22 at 15. Although Petitioner minimizes this issue,10 the record demonstrates that Resident 94’s consumption of alcohol was an ongoing problem, and one for which Petitioner’s staff struggled to find an effective approach. Petitioner’s staff documented that, on multiple occasions, Resident 94 left the facility, returning intoxicated or bringing alcohol into the facility. CMS Ex. 22 at 37-39, 43-45, 81. The record indicates that as early as July 8, 2013, the facility was aware that Resident 94 was becoming intoxicated while out in the community or bringing alcohol back to consume. CMS Ex. 22 at 37. The facility documented that Resident 94 “often” had alcohol in his room. CMS Ex. 22 at 85. Resident 94’s care plan documented that the resident displayed “[i]mpaired or inappropriate behaviors” of drinking alcohol while off facility property. CMS Ex. 22 at 43. The care plan further documented that Resident 94 had poor safety awareness and experienced “frequent falls when intoxicated.” CMS Ex. 22 at 47. In response to these areas of concern, Petitioner’s staff planned to implement interventions of educating Resident 94 on the risks of drinking alcohol, risks of crossing the highway, and policy of signing out when leaving facility property. CMS Ex. 22 at 43-45. Petitioner also planned to monitor unsafe behavior and notify the resident’s physician of such behavior or suspected alcohol use. CMS Ex. 22 at 44, 45. The original implementation date for these interventions was September 18, 2014, with a target date of December 18, 2014. See, e.g., CMS Ex. 22 at 43.

Petitioner documented that it educated Resident 94 on July 8, 2013, November 4, 2013, and December 28, 2014, informing him of the risks of consuming alcohol off-premises and that bringing alcohol onto facility property was prohibited. CMS Ex. 22 at 37-39. It is apparent, however, that Petitioner’s efforts to educate the resident were not effective in eliminating his problematic behavior of alcohol abuse. A Case Management Summary dated January 2, 2014, documented that Resident 94 experienced a fall secondary to alcohol consumption since the last review (the date of which was not specified). CMS Ex. 22 at 81. Although Resident 94 continued to exhibit the problem behaviors past the care-planned target date, there is no documentation that Petitioner implemented additional or different interventions. Nor is there any documentation that Petitioner ever notified Resident 94’s physician of the resident’s alcohol-related behaviors, as contemplated in the care plan.

In addition to Resident 94’s problem behaviors related to alcohol use, Petitioner’s records document that the resident demonstrated poor safety awareness. The January 2, 2014 Case Management Summary noted in the block for Mood/Behavior Prevention: “Remains non compliant [with] care & safety. Continues to sign out late evenings. Refusing any safety recommendations.” CMS Ex. 22 at 81. As with Resident 94’s alcohol use, his poor safety awareness appears to have been a continuing problem. On

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January 2, 2015, i.e. a year after the Case Management Summary was prepared, Petitioner’s nursing staff documented that the resident was initially discouraged from leaving the facility without signing out, but expressed that “he will leave whenever he pleases” without regard to the sign-out rule. CMS Ex. 22 at 84. Further evidence of his impaired safety awareness is Resident 94’s documented habit of crossing Highway 41 adjacent to the facility’s property, rather than at the marked crosswalk.11 CMS Ex. 22 at 43-47. Resident 94’s physician also described him as “reckless.” CMS Ex. 26 ¶ 16.

Given Resident 94’s well-documented history of alcohol abuse and poor safety awareness, it was readily apparent that the resident was at risk for experiencing an accident when he left the facility. Despite this, Resident 94’s care plan did not identify any specific approaches facility staff would implement to prevent him from experiencing accidents as a result of his history of intoxication, falls secondary to intoxication, and poor safety awareness. Moreover, despite Petitioner’s knowledge that Resident 94 engaged in particularly risky behaviors, including drinking alcohol and failing to use the crosswalk, Petitioner took no actions to address these behaviors, other than to provide education, which was demonstrated to be inadequate and ineffective. Then, on January 12, 2015, Resident 94 was struck by a car while crossing Highway 41 in front of the nursing home, sustaining multiple fractures. CMS Ex. 22 at 42.

Petitioner points out that there is no evidence that Resident 94’s alcohol use contributed to the specific accident on January 12, 2015. While true, this observation is beside the point. Similarly, Petitioner’s assertion that, as a matter of fact, Resident 94 had signed out on January 12, 2015, consistent with Petitioner’s policy (P. Br. at 11), does not demonstrate that Petitioner complied with 42 C.F.R. § 483.25(h).12 It is the pattern of failing to provide adequate supervision to protect Resident 94 from accidents that is at issue, not the actions of the resident on one particular day.

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Petitioner itself identified Resident 94’s behavior of alcohol abuse and his poor safety awareness as issues that it needed to address. Although Petitioner educated the resident, it is not clear that the facility enlisted the intervention of Resident 94’s physician, which was an approach it had care-planned. Similarly, it does not appear that the facility took steps to enforce its own policy prohibiting the consumption of alcohol on its premises.13 Moreover, when it became obvious that the care-planned approaches were not working, Petitioner should have undertaken additional or alternative approaches. At a minimum, if it is Petitioner’s position that Resident 94 was exercising his right to refuse care when leaving the facility and operating his motorized wheelchair in an unsafe manner, then Petitioner was required to ensure that Resident 94’s refusal was informed. To fulfill that duty, the facility must “assess what the potential consequences of refusal are and what alternatives could reasonably be offered that would not violate the resident’s rights.” Van Duyn Home, DAB No. 2368 at 8 (2011). Petitioner has made no showing that it did so here.

In the present case, there is no evidence that Petitioner considered, or offered, alternative approaches for dealing with Resident 94’s risky behaviors beyond repeated education. For example, there is no documentation that Petitioner’s staff offered to assist Resident 94 with crossing the highway, tried to impose limitations on his outings, searched his belongings for contraband upon his return from outings, or tried to ensure that his wheelchair had proper safety equipment to aid visibility when he crossed the highway. Had Petitioner considered and offered such alternatives and clearly documented that Resident 94 made an informed choice to refuse care, I would not find that Petitioner violated 42 C.F.R. § 483.25(h).

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.20(b)(1) (Tag F272) because it did not complete a comprehensive assessment of Resident 94’s ability to maneuver a motorized wheelchair in the community while taking into account his risky behaviors such as frequent intoxication and poor safety awareness.

A SNF is required to “conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident’s functional capacity.” 42 C.F.R. § 483.20. In performing the comprehensive assessment, the facility must assess the resident’s needs using the resident assessment instrument (RAI) specified by the State and include specific requirements of 42 C.F.R. § 483.20(b). However,

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“completion of the MDS/RAPs [Resident Assessment Protocols] does not necessarily fulfill a facility’s obligation to perform a comprehensive assessment. Facilities are responsible for assessing areas that are relevant to individual residents regardless of whether or not the appropriate areas are included in the RAI.” Additionally, . . . “The facility is responsible for addressing all needs and strengths of the resident regardless of whether the issue is included in the MDS or RAPs. The scope of the RAI does not limit the facility’s responsibility to assess and address all care needed by the resident.”

Maine Veterans’ Home-Scarborough, DAB No. 1975 at 17-18 (2005) (internal citations omitted). RAIs cannot incorporate every possible factor a facility should consider in individual resident assessments. Such an assessment necessarily includes evaluating the benefits and risks of a particular service utilized by a resident, such as a motorized wheelchair.

CMS alleges that Petitioner contravened these requirements because it failed to identify Resident 94’s risky behaviors, including alcohol consumption and poor safety awareness, and failed to assess his ability to safely operate his motorized wheelchair outside of the nursing home. CMS Br. at 8-9. Petitioner counters, “[t]hese positions are not supported by the facts.” P. Br. at 12. Rather, Petitioner asserts that it took Resident 94’s “individualized needs into consideration and provided an appropriate and adequate plan of care.” Id. I disagree.

Based on the record, I conclude that Petitioner did not substantially comply with 42 C.F.R. § 483.20(b)(1) because it failed to complete a comprehensive assessment of Resident 94, including his ability to safely operate his motorized wheelchair outside the facility, in light of his documented diagnoses and risk factors. As noted above, Resident 94 was admitted to Petitioner’s facility with existing diagnoses including paralysis on one side of his body due to a stroke, muscle weakness, muscle spasms, chronic pain, alcohol dependence, and a history of “drunkenness”. CMS Ex. 22 at 14-15. As described in the previous section of this decision, the record documents multiple instances in which, contrary to facility policy, Resident 94 consumed alcohol on Petitioner’s premises, or consumed alcohol while away from the facility and returned intoxicated. Notwithstanding this documentation, Petitioner did not complete an assessment of Petitioner’s alcohol consumption or implement any interventions other than education. Given that Resident 94 was admitted with a diagnosis of alcohol dependency, and given clear evidence that he was not maintaining sobriety, Petitioner should have assessed Resident 94 and, if necessary, consulted Resident 94’s physician to determine whether Resident 94’s behaviors supported a current diagnosis of a substance abuse disorder related to alcohol. Had Petitioner done so, perhaps the approaches and interventions

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Petitioner implemented would have been more effective in addressing Resident 94’s alcohol use and associated risky behaviors.

Further, Petitioner did not adequately assess and plan for Resident 94’s unsafe behavior while away from Petitioner’s facility. As previously discussed, Resident 94 was known to become intoxicated while away from the facility and was known to ignore safety precautions while crossing the highway outside the facility. Yet, Petitioner’s Physical Therapy Director told surveyors that facility staff did not take residents into the community for risk assessments and that the facility did not have a community safety awareness program. CMS Ex. 26 at 5. Since Resident 94’s poor safety awareness and noncompliance with safety precautions were well-documented, it was incumbent on Petitioner to consider these behaviors when assessing whether Resident 94 had the ability to operate his motorized wheelchair safely while in the community. Petitioner’s assessment of Resident 94’s wheelchair use did not do so.

On December 31, 2014, Petitioner’s occupational therapist (OT) assessed Resident 94’s ability to “safely navigate outdoors.” P. Ex. 9 ¶ 6. She did so by having him navigate around a parking lot adjacent to the facility, noting he had “no difficulty” and “was actually very good at maneuvering.” Id. However, in her “Initial OT Evaluation” dated December 30, 2014, the OT documented that Resident 94 had mild impairments in safety awareness, insight and judgment, and problem solving. CMS Ex. 22 at 96. She also noted that he needed moderate assistance with using the toilet and transfers. Id. The OT also listed as a short term goal of therapy that Resident 94 “will demonstrate good safety awareness while navigating facility in motorized [wheelchair].” CMS Ex. 22 at 97. By contrast, there is no similar goal indicating that Resident 94 would navigate his wheelchair safely in the community, or crossing the highway, taking into account his risky behaviors, especially his propensity to consume alcohol. In summary, Petitioner was aware of Resident 94’s risky behaviors, but did not evaluate his ability to safely maneuver his motorized wheelchair in the community while intoxicated. Therefore, Petitioner failed to complete a comprehensive assessment of Resident 94’s needs.

3. I need not address CMS’s contention that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.13(c) (Tag F224) and 483.15(a) (Tag F241) because it is not material to the outcome of this case.

Because CMS bases its imposition of a CMP on four deficiencies, I have the authority to review them all. See Schowalter Villa, DAB No. 1688 (1999). Nevertheless, in the interests of administrative economy, I do not consider the facility’s noncompliance with 42 C.F.R. §§ 483.13(c) or 483.15(a). I am permitted, “in the interests of judicial economy, [to] review only those deficiencies that have a material impact on the outcome of the dispute.” Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010). As my analysis in sections IV.B.1 and IV.B.2, supra, shows, Petitioner’s

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noncompliance with 42 C.F.R. §§ 483.25(h) and 483.20(b)(1) suffices to establish the reasonableness of the CMP proposed by CMS. Petitioner’s compliance (or not) with §§ 483.13(c) or 483.15(a) is therefore not material to the outcome of this case, and I thus decline to review these alleged deficiencies.

4. The remedy proposed is reasonable in amount and duration.

Regarding the amount of the CMP, I examine whether a CMP is reasonable by applying 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. The absence of culpability is not a mitigating factor. The factors listed in § 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. Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it. Coquina Ctr., DAB No. 1860 at 32 (2002).

The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of a CMP, $50 to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). In assessing the reasonableness of a CMP amount, an administrative law judge looks at the per-day amount, rather than the total accrued CMP. See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008). 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 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, DAB No. 2186 at 28-29.

Here, CMS imposed a CMP of $1,500 per day, which is in the middle range for below immediate jeopardy level noncompliance. CMS argues generally that the per-day CMPs proposed are reasonable because Petitioner has a history of noncompliance and a history of repeat deficiencies that support a more than minimal per-day CMP amount. CMS Br. 22; see CMS Ex. 7. Petitioner contends that it should not be held “strictly liable for a bad result when [it] took all reasonable steps to protect Resident 94.” P. Br. 23. Petitioner also points out that there is no support for any deficiency, much less one that

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resulted in actual harm. P. Br. 23. Petitioner has not asserted that it is unable to pay the CMP. See P. Br. at 24. Taking the regulatory factors into consideration, I agree with CMS that the CMP is reasonable in amount and duration.

Amount. As my analysis in sections IV.B.1 and IV.B.2, supra, shows, Petitioner’s noncompliance was very serious. I further conclude that Petitioner was culpable with respect to Resident 94’s accident in that Petitioner’s conduct evidenced a disregard for Resident 94’s safety. See 42 C.F.R. § 488.438(f)(4). Despite Petitioner’s education of Resident 94 regarding the risks of drinking alcohol and failing to use the crosswalk when crossing the highway, Resident 94 continued to exhibit the same behaviors. Nevertheless, Petitioner did not attempt any other interventions to abate Resident 94’s risky behaviors, which ultimately resulted in Resident 94 being hit by a car while crossing the highway in his wheelchair. Petitioner recognized the risks, knew it had a responsibility to protect Resident 94, and still failed to take all reasonable steps to mitigate the known risks. Furthermore, Petitioner failed to complete a comprehensive assessment of Resident 94 that included both his alcohol use as well as his risky behaviors and poor judgment and safety awareness. Nor did Petitioner comprehensively assess how those factors affected Resident 94’s ability to navigate his wheelchair while in the community. Consequently, I find that the severity of Petitioner’s noncompliance and Petitioner’s culpability amply justify the $1,500 per day CMP imposed here, which is in the middle range for below immediate jeopardy level noncompliance.14

Duration. The parties’ arguments about the reasonableness of the CMP focus on the amount of the CMP; they make no specific arguments about the reasonableness of the proposed duration of the CMP. The duration of the CMP is 60 days. The undisputed evidence supports the duration of the CMP. Petitioner was determined to be out of compliance on January 12, 2015. CMS Ex. 8. The state agency completed a follow-up

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survey on March 25 and 26, 2015, finding that Petitioner had returned to substantial compliance on March 13, 2015. CMS Ex. 9. Petitioner in turn failed to present evidence that it returned to substantial compliance earlier than March 13, 2015. Petitioner has thus not raised any issue as to the reasonableness of the duration of the CMP. I therefore conclude that the duration of the CMP is reasonable.

5. Petitioner’s challenge regarding CMS’s collection of the CMP is not subject to my review.

In its request for hearing and prehearing brief, Petitioner challenges the lawfulness of CMS collecting the proposed CMP and holding it in escrow pending the outcome of Petitioner’s appeal. See, e.g., P. Br. at 23-24. Petitioner asserts it is more than capable of paying the CMP and was not afforded due process to justify the withholding. However, when a SNF requests to participate in an IIDR process, the regulations provide that CMS “may collect and place the imposed civil money penalties in an escrow account . . . .” 42 C.F.R. § 488.431; see also Act § 1819(h)(2)(B)(ii)(IV); 42 C.F.R. § 488.331(a)(3).

Thus, Petitioner’s argument challenges the Secretary’s regulations and/or the Act. Such an argument does not raise an appealable issue under the federal regulations. 42 C.F.R. § 498.3(b) and (d). The regulations contain an explicit list of actions by CMS that comprise initial determinations that are subject to appeal. 42 C.F.R. §§ 498.3, 498.5. The method CMS uses to collect a CMP is not an “initial determination” subject to review. Therefore, it is not within my authority to review Petitioner’s arguments.

V. Conclusion

For the reasons set forth above, I sustain CMS’s determinations. I conclude that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.25(h) and 483.20(b)(1). I further find reasonable the $1,500 per-day CMP imposed from January 12 through March 12, 2015, for a total CMP of $90,000. I do not, however, address CMS’s determination that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.13(c) or 483.15(a) because those issues are not material to the outcome of this case. In light of the foregoing, I conclude that CMS imposed reasonable penalties for Petitioner’s substantial noncompliance with Medicare participation requirements.

• 1. The state agency also completed a Life Safety Code survey on February 9, 2015.  CMS Exhibit (Ex.) 3.  Petitioner has not appealed the deficiencies cited in that survey.  CMS Prehearing Brief (CMS Br.) at 2 n.2.
• 2. Effective November 28, 2016, CMS revised and reorganized many of the participation requirements codified in 42 C.F.R. pt. 483.  81 Fed. Reg. 68,688 (October 4, 2016).  I cite to the October 1, 2014 codification of the regulations that was in effect during the period January through March 2015, when the findings of substantial noncompliance were issued.
• 3. CMS and state survey agencies consider the scope and severity of deficiencies when selecting enforcement remedies.  CMS summarizes the scope and severity levels in a matrix published in the State Operations Manual (SOM).  SOM, CMS Pub. 100-07, chap. 7, § 7400.5.1 (Rev. 63, effective Sept. 10, 2010) (the current version, Rev. 161, effective September 23, 2016, did not change the substance of the matrix).  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each scope and severity level.  “Scope” describes how many residents are potentially affected by a particular deficiency.  Deficiencies may be “isolated,” “pattern,” or “widespread” in scope.  “Severity” describes the possible harm that a deficiency may cause.  A scope and severity level of A, B, or C describes a deficiency that causes no actual harm with the potential for minimal harm.  Facilities cited with deficiencies at level C or lower remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F describes a deficiency that has caused no actual harm with the potential for more than minimal harm that is not immediate jeopardy.  A scope and severity level of G, H, or I describes a deficiency that has caused actual harm that is not immediate jeopardy.  Scope and severity levels J, K, and L describe deficiencies that pose immediate jeopardy to resident health or safety.
• 4. The deficiencies at Tags F272, F323, and F353 were cited in the statement of deficiencies for the complaint survey.  CMS Ex. 1.  The remaining deficiencies were cited in the statement of deficiencies for the recertification survey.  CMS Ex. 2.
• 5. Petitioner’s objections to CMS’s proposed exhibits appear at docket entry #6 in the electronic file for this case.  Docket entry #6 is incorrectly labeled as Petitioner’s proposed list of witnesses.  Correspondingly, Petitioner’s witness list appears at docket entry #8, which is mislabeled as containing Petitioner’s objections.
• 6. Petitioner’s closing brief does not identify the specific exhibits to which it objects.  P. Closing Br. at 14, 16.  However, the statements to which Petitioner refers appear in CMS Exs. 27 and 34.  Although I admit CMS Exs. 27 and 34, I would ordinarily consider Petitioner’s hearsay objections when deciding what weight to give the evidence.  But, it is unnecessary for me to do so in the present case, as I do not rely on the alleged deficiencies involving Residents 33 and 43 to establish that Petitioner failed to comply substantially with Medicare participation requirements.
• 7. Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, 129 Stat. 584, 599, CMS recently increased CMP amounts to account for inflation.  The new adjusted amounts apply to CMPs assessed after August 1, 2016, for deficiencies occurring on or after November 2, 2015.  See 81 Fed. Reg. 61,538 (Sept. 6, 2016).  As the deficiencies alleged in this case occurred prior to November 2, 2015, the increased CMP amounts do not apply in this case.
• 8. My findings of fact and conclusions of law appear as headings in bold italic type.
• 9. I acknowledge that the reference to “behaviorally impaired residents” in Vandalia Park contemplates residents diagnosed with dementia or other mental impairments that may result in behavioral disturbances.  However, as I discuss below, Petitioner in the present case assessed Resident 94 as experiencing inappropriate behaviors related to alcohol use.  Accordingly, I find the reasoning of the panel in Vandalia applicable here.
• 10. Petitioner states that Resident 94 “was known to drink alcohol on occasion.”  P. Br. at 10.
• 11. One of the state agency surveyors, in her written direct testimony, describes Highway 41 as a major six-lane highway.  CMS Ex. 26 ¶ 13.  The surveyor further states:  “There is no stop light or marked crossing in front of the facility.”  Id.
• 12. The record contains a resident sign in and out sheet with dates from January 9, 2015 through January 13, 2015.  CMS Ex. 22 at 41; CMS Ex. 30.  Between two entries for January 10, 2015, there is an entry that includes Resident 94’s name, the date “1/12” and the time “4:00 p.m.”  I do not find the log convincing for several reasons.  First, the entries on the page are not consecutive.  The entry for Resident 94 that purports to be for January 12 appears in the middle of five entries for January 10; and, Resident 94’s January 12 entry is distant by seven lines from the next January 12 entry.  Second, Resident 94’s name appears three times on the sign out sheet, yet to my untrained eye, the handwriting does not appear to be the same.  Therefore, I am unable to conclude from the sign out sheet that Resident 94 in fact signed himself out of the facility on January 12, 2015.
• 13. While the record demonstrates that on at least one occasion Petitioner informed Resident 94 that consuming alcohol on Petitioner’s property could result in discharge, there is no evidence that Petitioner ever issued a discharge notice to Resident 94, even though the behavior continued.  CMS Ex. 22 at 38.
• 14. I directed the parties to address in their briefs the authority of the administrative law judge to increase the amount of CMPs imposed by CMS.  Briefing Order at 2.  Petitioner argues that the amount of the CMP imposed is a matter for CMS’s discretion and, accordingly, the administrative law judge should not substitute his or her judgment for that of CMS.  P. Closing Br. at 20.  CMS argues that an administrative law judge is authorized to increase the amount of the CMP.  CMS Closing Br. at 14.  Moreover, CMS argues that, in the present case, I would be justified in increasing the CMP to the immediate jeopardy range because Petitioner’s noncompliance was likely to cause serious injury, harm, impairment, or death to Resident 94.  Id. at 14-15.  Because I have ultimately decided to uphold the amount of the CMP as originally imposed, I need not resolve this issue.  Nevertheless, I believe I am authorized to impose a different CMP amount (either higher or lower) within the range appropriate to the cited deficiencies.  However, I am not convinced that I may change a deficiency citation to the immediate jeopardy level, if CMS did not cite immediate jeopardy at the outset, absent a finding of clear error.  See 42 C.F.R. § 498.60(c)(2) (CMS’s determination as to the level of noncompliance must be upheld unless it is clearly erroneous).