throbber
NOT RECOMMENDED FOR PUBLICATION
`File Name: 20a0611n.06
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`No. 19-3755
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`UNITED STATES COURT OF APPEALS
`FOR THE SIXTH CIRCUIT
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`Petitioner,
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`GOLDEN LIVING CENTER – MOUNTAIN
`VIEW,
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`v.
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`SECRETARY OF HEALTH AND HUMAN
`SERVICES; UNITED STATES DEPARTMENT
`OF HEALTH AND HUMAN SERVICES
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`
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`Respondents.
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`)
`)
`)
`)
`)
`)
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`)
`)
`)
`)
`
`ON PETITION FOR REVIEW
`FROM THE UNITED STATES
`DEPARTENT OF HEALTH
`AND HUMAN SERVICES
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`BEFORE: BOGGS, CLAY, and GIBBONS, Circuit Judges.
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`JULIA SMITH GIBBONS, Circuit Judge. Petitioner Golden Living Center – Mountain
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`View (“Mountain View”) is a Tennessee skilled nursing facility (“SNF”) that participates in the
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`federal Medicare and Medicaid programs. As a participant in these programs, Mountain View is
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`required to be in substantial compliance with federal requirements for such facilities. Following
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`an inspection of the facility in April 2014, when inspectors learned of an increase in patient falls
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`in the Alzheimer’s Care Unit (“ACU”), Centers for Medicare and Medicaid Services (“CMS”)
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`determined that Mountain View was not in substantial compliance with several regulatory
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`requirements. CMS imposed a civil monetary penalty (“CMP”) in the amount of $621,250. An
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`administrative law judge (“ALJ”) and the Departmental Appeals Board of the Department of
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`Health and Human Services (“DAB”) both affirmed the administratively imposed penalties.
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`Mountain View appeals the DAB decision, arguing that the imposition of the CMP was
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`arbitrary and capricious because it did not have notice from the statute or regulations that CMS
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`would fine it for not considering adding additional staff. While it seems likely that CMS may have
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`gathered sufficient evidence to find that Mountain View was not in compliance with the
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`regulations due to the increased falls that residents experienced without adequate intervention from
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`the facility, the DAB’s decision rested exclusively on Mountain View’s failure to consider
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`increasing its staffing. Because the regulations that CMS cited did not provide notice to Mountain
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`View that it must specifically consider increased staffing and review each patient’s care plan after
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`every fall, we agree that CMS’s decision was arbitrary and capricious. We reverse and remand to
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`the DAB for proceedings consistent with this opinion.
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`I.
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`A.
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`Mountain View is a skilled nursing facility in Tennessee that participates in the federal
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`Medicare and Medicaid programs. See 42 C.F.R. § 488.3 (as effective 2014). As a skilled nursing
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`facility, it is required to comply with 42 U.S.C. § 1395i-3 and 42 C.F.R. § 483, and it is surveyed
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`periodically to assure compliance with federal regulations, see id. §§ 488.7; 488.20; 488.308.
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`A state agency, with CMS authorization, surveys facilities and records instances of
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`noncompliance known as deficiencies. See id. § 488.404(b). The surveyors note deficiencies and
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`assign scope and severity levels, indicated by an alphabetic character A through L, ranging from
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`the lowest, “no actual harm but has the potential for minimum harm,” to the highest,
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`noncompliance that causes “immediate jeopardy to resident health or safety.” (CA6 R. 16, Pet’r
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`Am. App., ALJ Am. Decision, PageID 34 n.4.) Immediate jeopardy occurs when noncompliance
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`“has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”
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`42 C.F.R. § 488.301 (as effective 2014).
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`If CMS finds that a facility’s noncompliance has placed residents in immediate jeopardy,
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`CMS can impose a CMP ranging from $3,050 to $10,000 per day. Id. § 488.438(a)(1)(i). For
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`deficiencies of lesser severity that caused harm or have the potential for more than minimal harm,
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`CMS may impose a CMP ranging from $50 to $3,000 per day. Id. § 488.438(a)(1)(ii).
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`CMS mails a notice of its determination to the facility under 42 C.F.R. § 498.20(a)(1), and
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`a nursing facility dissatisfied with an initial determination is entitled to a hearing before an ALJ
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`under § 498.5(b) and § 488.408(g) if it files a request within 60 days of the determination. Id.
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`§§ 498.40(a)(2), 488.330(e)(3). The request for a hearing must specify the findings of fact and
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`legal conclusions with which the provider disagrees and the basis for those contentions. Id.
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`§ 498.40(b). An ALJ, under § 488.438(e), may not reduce or set a penalty to zero or review CMS’s
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`exercise of discretion in selecting a penalty if the ALJ finds there is a basis for imposing the
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`penalty. Id. § 498.60(c).
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`An ALJ reviews de novo the legal and factual basis for the alleged regulatory
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`noncompliance. Life Care Ctr. of Bardstown v. Sec’y U.S. Dep’t of Health & Human Servs.,
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`2012 WL 5290709, No. 2479, *7 n.4 (DAB 2012) (“The ALJ review is de novo, and the ‘issue
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`before the ALJ is “whether the evidence as it is developed before the ALJ” supports the finding of
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`noncompliance, “not . . . how CMS evaluated the evidence as it stood at whatever point CMS made
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`its assessment.”’” (quoting Sunbridge Care & Rehabilitation for Pembroke, No. 2170 (DAB
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`2008))) aff’d 535 F. App’x 468 (6th Cir. 2013). Additionally, “CMS’[s] determination as to the
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`level of noncompliance of [a skilled nursing facility] [i.e. immediate jeopardy] . . . must be upheld
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`unless it is clearly erroneous.” Id. at *27.
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`A facility dissatisfied with the hearing decision by the ALJ may request review by the DAB
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`and may seek judicial review of the DAB’s decision by filing a request for review within 60 days
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`of the ALJ decision. 42 C.F.R. §§ 498.5(c); 498.82. The request for review “must specify the
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`issues, the findings of fact or conclusions of law with which the party disagrees, and the basis for
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`contending that the findings and conclusions are incorrect.” Id. § 498.82(b). Review is conducted
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`by a panel of at least two members of the DAB, and the DAB may admit into the record additional
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`evidence it believes relevant and material. Id. § 498.86(a). The DAB’s decision must be “based
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`upon the evidence in the hearing record and any further evidence that the [DAB] receive[d] during
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`its review” and must be “in writing and contain[] separate numbered findings of fact and
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`conclusions of law.” Id. § 498.88(f). The DAB reviews factual issues to determine if the “ALJ
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`decision is supported by substantial evidence in the record as a whole” and legal issues to
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`determine if the “ALJ decision is erroneous.” Avon Nursing Home, 2017 WL 7734852, No. 2830,
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`*7 (DAB 2017). A party dissatisfied with the DAB’s determination is then entitled to seek judicial
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`review within 60 days. 42 C.F.R. § 498.5.
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`B.
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`The factual background of this case is nearly undisputed. From March 31, 2014 through
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`April 11, 2014, surveyors from the Tennessee State Survey Agency (“SSA”), pursuant to an
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`agreement with CMS, conducted an annual recertification and extended survey of operations at
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`Mountain View. See id. § 488.10 (as effective in 2014). The surveyors uncovered and observed
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`numerous instances where Mountain View was not in substantial compliance with federal
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`regulations. Specifically, the surveyors determined that Mountain View’s noncompliance with
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`seven regulations (noted under six F-Tags) posed immediate jeopardy. These violations included:
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`“42 C.F.R. §§ 483.20(d)(3) and 483.10(k)(2) [“F280”] (care plans); 483.25(h) [“F323”]
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`(accident hazards); 483.30(a) [“F353”] (adequate staffing); 483.75 [“F490”] (administration);
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`483.75(i) [“F501”] (medical director); and 483.75(o)(1) [“F520”] (Quality Assurance
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`Committee).” (AR 278, Vol. 1., Joint Stipulations.)1 The surveyors also noted other deficiencies
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`at lower severity levels, but these deficiencies were not challenged by Mountain View.
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`The basis for all of the deficiencies posing immediate jeopardy was numerous unwitnessed
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`falls, over forty during a period of four months, by five residents of Mountain View’s Alzheimer’s
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`Care Unit (“ACU”). Mountain View has a specially licensed ACU that houses between thirty to
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`thirty-five residents diagnosed with Alzheimer’s disease or other cognitive disorders who are “able
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`to pivot during transfer and be ambulatory, but may use a walker, wheelchair, or other assistive
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`devices.” (CA6 R. 15, Pet’r Am. App., ALJ Decision, PageID 40.) Each resident was determined
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`to be at a high risk for falls due to various mental and physical ailments. These falls caused injuries,
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`requiring emergency medical evaluation or first aid. The surveyors concluded that the repeated,
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`unwitnessed falls placed these five residents in immediate jeopardy.
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`CMS notified Mountain View of the deficiencies on April 23, 2014. CMS imposed an
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`initial civil monetary penalty (“CMP”) on Mountain View in the amount of $5,800 per day,
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`effective January 13, 2014, until the facility achieved substantial compliance.
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`Subsequently, on May 1, 2014, the Tennessee SSA conducted a revisit survey to determine
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`whether Mountain View had achieved substantial compliance. The surveyors concluded that
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`Mountain View was still not in substantial compliance, but also noted these deficiencies no longer
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`posed immediate jeopardy to its residents. CMS modified the CMP to accrue at a rate of $150 per
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`day, effective April 29, 2014, until CMS determined the facility was in substantial compliance.
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`Tennessee SSA conducted a second revisit survey on June 11, 2014 and found that Mountain View
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`had returned to substantial compliance. CMS imposed a total CMP of $621,250; CMS first applied
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`1 Both CMS and the ALJ incorrectly cited the regulatory violation as § 483.20(d)(3) instead of § 483.10(d)(3), and
`§ 483.10(k)(2) instead of § 483.20(k)(2). The DAB noted and corrected this error.
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`a penalty of $5,800 per day for a total of 106 days then modified the penalty to $150 per day for a
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`period of 43 days.
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`Mountain View appealed the penalty. Under the Hillman standard applied by the ALJ and
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`DAB, the agency must first provide evidence sufficient to establish a prima facie case of the
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`regulatory violation. Hillman Rehabilitation Ctr. v. Health Care Financing Admin., 1997 WL
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`123708, No. 1611 (DAB 1997). Once the agency has met its burden, then the burden of persuasion
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`shifts to the facility to “prove by a preponderance of the evidence on the record as a whole that it
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`is in substantial compliance with the relevant statutory and regulatory provisions.” Id. at *4–5.
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`The DAB continues to apply this burden-shifting framework in analyzing the penalty against
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`Mountain View. (CA6 R. 15, Pet’r Am. App., DAB Decision, PageID 14.)
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`The ALJ concluded that “CMS ha[d] made a prima facie showing of noncompliance under
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`Tags F280, F323, F353, F490, F501, and F520.” (CA6 R. 15, Pet’r Am. App., ALJ Decision,
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`PageID 14, 74.) The ALJ specifically relied on the undisputed evidence of the residents’ falls, that
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`Mountain View’s staffing for direct care fell below the level required for an ACU by Tennessee
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`regulation establishing the presumptive standard of practice, and the surveyors’ perceptions that
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`“staff on duty were having difficulty delivering the level of care and services residents required
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`during the period of the survey.” (Id. at 76.)
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`Rather than holding that CMS had sufficient evidence from which to infer noncompliance
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`with the relevant regulations, the ALJ found that Mountain View was noncompliant with F323
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`(“Accidents”) purely because it failed to consider adding additional staffing. The ALJ in turn
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`relied on the violation of F323 to affirm CMS findings of violations under F323, F490, F501 and
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`F520. The ALJ reasoned that “[i]ncreasing staff is an obvious potential intervention to address
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`increased resident needs, something the [Quality Assurance] committee and management failed to
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`consider.” (CA6 R. 15, Pet’r Am. App., ALJ Decision, PageID 83.) The ALJ continued: “[I]t
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`should have been obvious to the QA committee and management that the staffing ratio on the ACU
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`may have required adjustment to provide additional supervision and assistance to the five residents
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`experiencing an increase in falls.” (Id.) The ALJ rejected Mountain View’s defense that the falls
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`were unavoidable because Mountain View “cannot establish its defense by a preponderance of the
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`evidence when it cannot show that increased staffing or an adjustment of staffing on the ACU was
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`not an appropriate and effective intervention.” (Id.)
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`The DAB affirmed the ALJ’s decision. The DAB summarily “conclude[d] without further
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`discussion that substantial evidence supports the ALJ decision on all material factual issues”
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`because Mountain View “d[id] not specifically argue that the ALJ Decision is not supported by
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`substantial evidence,” rather it alleged legal errors by the ALJ. (CA6 R. 15, Pet’r Am. App., DAB
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`Decision, PageID 16–17.) Mountain View timely appealed.
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`II.
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`Our review of DAB decisions is highly deferential. Woodstock Care Ctr. v. Thompson,
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`363 F.3d 583, 588 (6th Cir. 2003). With respect to questions of fact, “[t]he findings of the
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`Secretary . . . if supported by substantial evidence on the record considered as a whole, shall be
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`conclusive.” Id. (quoting 42 U.S.C. § 1320a-7a). “When conducting substantial evidence review,
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`this Court examines the record as a whole and takes into account whatever in the record fairly
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`detracts from the weight of the evidence below.” Claiborne-Hughes Health Ctr. v. Sebelius,
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`609 F.3d 839, 843 (6th Cir. 2010) (quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 488
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`(1951)). The court “do[es] not consider the case de novo, nor resolve conflicts in the evidence,
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`nor decide questions of credibility.” MeadowWood Nursing Home v. U.S. Dep’t of Health
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`& Human Servs., 364 F.3d 786, 788 (6th Cir. 2004) (quoting Myers v. Sec’y of Health & Human
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`Servs., 893 F.2d 840, 842 (6th Cir. 1990)).
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`As to questions of law, an agency’s interpretation of statutes “[is] given controlling weight
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`unless [it is] arbitrary, capricious, or manifestly contrary to the statute.” Chevron, U.S.A., Inc. v.
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`Nat. Res. Def. Council, 467 U.S. 837, 843 (1984). If a statute’s meaning is plain, courts “must
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`give effect to the unambiguously expressed intent of Congress.” Chevron, U.S.A., Inc., 467 U.S.
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`at 843. Under Chevron, a court will defer to an agency’s reasonable interpretation when “Congress
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`has explicitly left a gap for the agency to fill” or if the statute is ambiguous after application of
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`“traditional tools of statutory construction.” See Chevron, 467 U.S. at 843 n.9, 843–44, 865; see
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`also Kisor v. Wilkie, 139 S. Ct. 2400, 2415 (2019).
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`Under Auer v. Robbins, 519 U.S. 452 (1997), deference is also sometimes due to an
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`agency’s interpretation of a genuinely ambiguous regulation (formerly known as Seminole Rock
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`deference). Kisor, 139 S. Ct. at 2414. Such interpretations are not substantive rules, and thus do
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`not create or carry the force of law. Dismas Charities, Inc. v. Dep’t of Justice, 401 F.3d 666 (6th
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`Cir. 2005) (quoting First Nat’l Bank v. Sanders, 946 F.2d 1185, 1188–89 (6th Cir. 1991)); Azar v.
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`Allina Health Servs., 139 S. Ct. 1804, 1811 (2019) (“‘[I]nterpretive rules’ are those that merely
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`‘advise the public of the agency’s construction of the statutes and rules which it administers.’”
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`(quoting Perez v. Mortg. Bankers Ass’n, 575 U.S. 92, 97 (2015))); Nat’l Min. Ass’n v. McCarthy,
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`758 F.3d 243, 252 (D.C. Cir. 2014) (“An agency action that merely explains how the agency will
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`enforce a statute or regulation—in other words, how it will exercise its broad enforcement
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`discretion or permitting discretion under some extant statute or rule—is a general statement of
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`policy.”).
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`In reviewing an agency’s interpretation of a regulation, a court must first “resort[] to all the
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`standard tools of interpretation” to determine if the regulation is genuinely ambiguous. Kisor,
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`139 S.Ct. at 2414. Further, not all interpretations are entitled to deference; no deference is
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`warranted for an agency interpretation that “does not reflect an agency’s authoritative, expertise-
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`based, ‘fair[, or] considered judgment.’” Id. (alteration in original) (quoting Christopher v.
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`SmithKline Beecham Corp., 567 U.S. 142, 155 (2012)). An agency’s interpretation must be
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`reasonable, meaning “it must come within the zone of ambiguity the court has identified after
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`employing all its interpretive tools.” Id. at 2416. The agency’s interpretation must also be “the
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`agency’s ‘authoritative’ or ‘official position,’ rather than . . . [an] ad hoc statement not reflecting
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`agency views,” “implicate its substantive expertise,” and “must reflect ‘fair and considered
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`judgment.’” Id. at 2416–17.
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`An ad hoc interpretation arising in the context of an enforcement proceeding receives no
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`deference under Auer, as it is not an official agency position, and would “unfairly surprise the
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`sanctioned party and ‘seriously undermine the principle that agencies should provide regulated
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`parties fair warning of the conduct [a regulation] prohibits or requires.’” Elgin Nursing
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`& Rehabilitation Ctr. v. U.S. Dep’t of Health & Human Services, 718 F.3d 488, 493–94 (5th Cir.
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`2013) (quoting SmithKline Beecham Corp., 567 U.S. at 156) (quotation marks omitted)).The
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`Supreme Court has, therefore, counseled reticence in applying agency interpretations that give rise
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`to “unfair surprise.” Id. at 158 (refusing to rely on an agency interpretation of a regulation
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`advanced for the first time in an amicus brief filed the same year the litigation commenced); see
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`also Kisor, 139 S. Ct. at 2421 (“[D]eference turns on whether an agency’s interpretation creates
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`unfair surprise or upsets reliance interests.”).
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`No. 19-3755, Golden Living Center v. HHS
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`Our review of the CMP is also governed by the Administrative Procedure Act (“APA”).
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`An agency’s decision is arbitrary and capricious if “the agency has relied on factors which
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`Congress has not intended it to consider, entirely failed to consider an important aspect of the
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`problem, offered an explanation for its decision that runs counter to the evidence before the agency,
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`or is so implausible that it could not be ascribed to a difference in view or the product of agency
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`expertise.” Taylor v. Principi, 92 F. App’x 274, 276–77 (6th Cir. 2004) (quoting Henry Ford
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`Health Sys. v. Shalala, 233 F.3d 907, 911 (6th Cir. 2000)). “At base, arbitrary and capricious
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`review functions to ‘ensur[e] that agencies have engaged in reasoned decisionmaking.’” Atrium
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`Med. Ctr. v. U.S. Dep’t of Health & Human Servs., 766 F.3d 560, 567 (6th Cir. 2014) (quoting
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`Judulang v. Holder, 565 U.S. 42, 53 (2011)).
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`If an agency interpretation would not provide fair notice to the regulated parties, then the
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`courts should not defer to it, and instead must review the agency interpretation of the regulation to
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`determine whether the agency’s action is “arbitrary and capricious” or “not in accordance with
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`law.” 5 U.S.C. § 706(2); Kisor, 139 S.Ct. at 2414 (“Auer deference is not the answer to every
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`question of interpreting an agency's rules. Far from it. As we explain in this section, the possibility
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`of deference can arise only if a regulation is genuinely ambiguous”).
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`III.
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`Mountain View claims that the facility was in substantial compliance with the applicable
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`regulations and that the DAB’s decision was arbitrary and capricious because it failed to provide
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`a reasoned basis for determining Mountain View’s obligation to consider additional staffing under
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`each of the cited regulatory violations. Because neither the ALJ nor the DAB offered explanations
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`supporting the conclusion that the facility was on notice that it must consider additional staffing
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`under each of the alleged regulatory violations, we remand to the DAB for further proceedings.
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`Because the ALJ and DAB narrowly rested their decision on the failure to consider staffing, a basis
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`on which Mountain View had no notice anywhere in the regulations, we do not address the broader
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`issue of Mountain View’s compliance.
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`The question before this court is not whether, based on the totality of the evidence, the ALJ
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`or DAB could properly have found that Mountain View was not in compliance with the
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`regulations. Rather, the question is whether CMS had properly put Mountain View on notice that
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`failure to consider adding additional staffing in the face of unwitnessed falls would constitute a
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`violation. We hold that it did not.
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`A.
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`Congress created the Medicaid and Medicare programs and delegated authority to the
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`Secretary of HHS to promulgate regulations necessary to carry out the administration of these
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`programs. See 42 U.S.C. § 1395hh. Within HHS, CMS was created to manage the federal
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`Medicare and Medicaid programs. Centers for Medicare & Medicaid Services, 66 Fed. Reg.
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`35437-03 (July 5, 2001). The Administrator of CMS has delegated authority to promulgate
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`regulations to implement the various federal programs that CMS controls. Id. Pursuant to this
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`authority, it promulgates both substantive rules and interpretive rules.
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`CMS’s substantive rules governing skilled nursing facilities, like Mountain View, have the
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`force of law because they conform with the procedural requirements of notice and comment and
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`“affect[] individual rights and obligations.” Chrysler Corp. v. Brown, 441 U.S. 281 (1979)
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`(quoting Morton v. Ruiz, 415 U.S. 199, 235 (1974)).
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`On the other hand, CMS has issued interpretative rules in agency manuals, such as the State
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`Operations Manual (“SOM”) at issue here, interpreting these regulations. Clarian Health West,
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`LLC v. Hargan, 878 F.3d 346, 380 (D.C. Cir. 2017) (CMS Manual “instructions are a general
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`statement of policy”).
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`Further, CMS interprets its own regulations ad hoc, for example, through litigation
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`positions. Kisor v. Wilkie, 139 S. Ct. 2400, 2417 (2019). Such agency guidance does not require
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`notice and comment, and does “not have the force of law.” Id.; 5 U.S.C. § 553(b)(3)(A). As
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`explained above, deference is due to an agency’s interpretation of a genuinely ambiguous
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`regulation, Kisor, 139 S. Ct. at 2414, but an interpretive rule, such as the one in question, “receives
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`no deference under Auer.” Gonzales, 546 U.S. at 258. Additionally, “[w]hen an agency
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`promulgates regulations it is… bound by those regulations. It may not attempt to subvert the rule-
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`making process through interpretations that find no support in the regulation's language.” A.D.
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`Trasport. Express, Inc. v. United States, 290 F.3d 761, 766 (6th Cir. 2002). Relying on these
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`precedents, other circuits have declined to defer to CMS’s interpretation of the SOM in an
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`enforcement action precisely because doing so deprived the nursing home “of fair notice of the
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`wrong to be avoided.” Elgin Nursing & Rehabilitation Ctr. v. Dep’t of Health & Human Servs.,
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`718 F.3d 488, 493–94 (5th Cir. 2013) (discussing Christopher v. SmithKline Beecham Corp., 567
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`U.S. 142 (2012)). Nowhere in the regulations does CMS put nursing homes on notice that
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`consideration of additional staffing will be dispositive. Instead, CMS argues that it is “obvious.”
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`Because this interpretation of this regulation arose through enforcement, rather than notice and
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`comment, we do not give it the deference that we give substantive rules that went through the
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`notice and comment process. Kisor, 139 S.Ct.at 2418; Auer v. Robbins, 519 U.S. 452 (1997).
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`After determining whether deference is appropriate, we determine whether the agency’s
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`application of the regulation to Mountain View was arbitrary and capricious.
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`B.
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`CMS found that Mountain View was not in substantial compliance with seven regulations
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`at a level causing immediate jeopardy to its residents. These violations included: “42 C.F.R.
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`§§ 483.20(d)(3) and 483.10(k)(2) [“F280”] (care plans); 483.25(h) [“F323”] (accident hazards);
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`483.30(a) [“F353”] (adequate staffing); 483.75 [“F490”] (administration); 483.75(i) [“F501”]
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`(medical director); and 483.75(o)(1) [“F520”] (Quality Assurance Committee).” (AR 278, Vol. 1,
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`Joint Stipulations.) We review each regulation below.
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`On appeal, Mountain View argues that it lacked fair notice of the regulations’ requirement
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`that a skilled nursing facility consider additional staffing in response to an increase in falls and
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`revise a patient’s care plan after every fall. CMS argues that the requirement represents a common-
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`sense understanding of the regulations. We agree with Mountain View. The regulations did not
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`provide Mountain View fair notice that it was required to consider additional staffing in response
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`to an increase in falls. As an ad hoc interpretation of its own regulations, arising solely through
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`enforcement, this interpretation is owed no deference, and we find that it was arbitrary and
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`capricious.
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`Additionally, substantial evidence does not support the ALJ’s and DAB’s conclusions that
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`Mountain View was not reviewing resident care plans after falls, that it did not have adequate
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`nursing staff, that the quality assurance committee was not properly constituted, and that Mountain
`
`View’s Medical Director was failing to ensure Mountain View’s policies and procedures were
`
`being implemented. Accordingly, we reverse the DAB’s decision in full.
`
`1. F280: Violations of 42 C.F.R. §§ 483.10(d)(3) and 483.20(k)(2)
`
`Section 483.10(d)(3), as effective in 2014, provides that a resident has the right to, “[u]nless
`
`adjudged incompetent or otherwise found to be incapacitated under the laws of the State,
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`13
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`No. 19-3755, Golden Living Center v. HHS
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`participate in planning care and treatment or changes in care and treatment.” In 2014,
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`§ 483.20(k)(2), regarding comprehensive care plans, provided: “A comprehensive care plan must
`
`be—(i) Developed within 7 days after completion of the comprehensive assessment; (ii) Prepared
`
`by an interdisciplinary team, that includes the attending physician, a registered nurse with
`
`responsibility for the resident, and other appropriate staff in disciplines as determined by the
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`resident’s needs, and, to the extent practicable, the participation of the resident, the resident’s
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`family or the resident’s legal representative; and (iii) Periodically reviewed and revised by a team
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`of qualified persons after each assessment.”
`
`“Periodic” leaves some ambiguity as to how frequently a facility must review and revise a
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`resident’s care plan. The dictionary provides that “periodic” means “recurring at regular intervals”
`
`or “intermittently.” Periodic, Oxford English Dictionary (3d ed. 2005). Those definitions resolve
`
`some ambiguity—they clarify review and revision of care plans occurs “regularly,” rather than in
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`response to certain events—they leave other ambiguities—namely, how much time should pass
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`between each review and revision.
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`CMS’s statement of deficiencies provides that Mountain View was not in substantial
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`compliance with section 42 C.F.R. §§ 483.10(d)(3) and 483.20(k)(2) because “the facility failed
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`to follow policy to revise care plans after every fall for appropriate interventions to prevent further
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`falls” for the five residents in the ACU. (CA6 R. 18, Resp’t App., Statement of Deficiencies,
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`PageID 71.) “The facility’s failure to review and revise residents’ care plans, develop, and
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`implement appropriate interventions to prevent falls placed [the residents] in [i]mmediate
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`[j]eopardy.” (Id.) As evidence of this noncompliance, CMS cited each resident’s medical records
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`documenting the falls and noted whether additional interventions were implemented or added to a
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`resident’s care plan after each fall.
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`
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`14
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`No. 19-3755, Golden Living Center v. HHS
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`The ALJ, reviewing the Statement of Deficiencies and the surveyors’ testimony,
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`determined that one surveyor found Mountain View “deficient because residents fell and no new
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`intervention was added to their care plan,” and similarly, the other surveyor concluded that “the
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`fall had to be assessed and a new intervention added to ensure that the resident does not fall again.”
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`(CA6 R. 15, Pet’r Am. App., ALJ Decision, PageID 63–64.)
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`The ALJ, interpreting the regulation, found that “483.20(k) does not impose a requirement
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`and the parties have identified no standard of practice that requires that a new intervention be
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`implemented or that interventions be changed due to the occurrence of an accident[, and]
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`conclude[d] that failure to implement a new intervention following a fall, standing alone, [wa]s
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`not a sufficient basis to find noncompliance.” (Id. at 78–79.) Despite determining that under the
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`regulation a provider was not required to change an intervention or implement a new intervention
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`after every fall, and finding that “[t]he evidence summarized above shows that the residents’ IDTs
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`were actively involved in assessing, implementing interventions, and evaluating the effectiveness
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`of those interventions,” the ALJ concluded that Mountain View was not substantially compliant
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`with these regulations.2 (Id.) This determination, as upheld by the DAB, was not supported by
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`substantial evidence.
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`The regulation is clear on its face that an IDT is required to develop a comprehensive care
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`plan and “periodically review and revise” it. § 483.20(k)(2). Mountain View reviewed each
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`resident’s care plan after a fall and modified the care plan to add or change resident interventions
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`as needed. There was “no dispute about the material facts establishing and surrounding each fall.”
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`(CA6 R. 15, Pet’r Am. App., DAB Decision, PageID 13.) The only question for the ALJ and DAB
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`2 Notably, the ALJ also affirmed the CMS’s determination of noncompliance with §§ 483.20(d)(3) and 483.10(k)(2),
`which are not the correct regulatory provisions. Although the ALJ cited the correct regulatory sections when
`describing the requirements a provider must adhere to, the ALJ did not correctly include these regulations in his
`conclusions of law.
`
`
`
`
`15
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`No. 19-3755, Golden Living Center v. HHS
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`to resolve was whether, as presented by the undisputed facts, CMS’s interpretation of the
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`regulation that Mountain View was required to add or change its interventions after each instance
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`of a resident fall in order to be in substantial compliance was consistent with the regulations.
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`CMS’s interpretation, as the ALJ pointed out, is inconsistent with the regulations requiring
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`periodic review. Moreover, Mountain View was not on notice that CMS interpreted the
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`regulations to require it to amend patients’ care plans after every fall to be in substantial
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`compliance with the regulation. The DAB erred in concluding that CMS met its burden to show
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`that Mountain View violated these regulations.
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`2. F323: Violation of 42 C.F.R. § 483.25(h)
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`Section 483.25(h), as in effect in 2014, requires the facility to “ensure that — (1) [t]he
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`resident environment remains as free of accident hazards as is possible; and (2) [e]ach resident
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`receives adequate supervision and assistance devices to prevent accidents.” The regulation is
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`ambiguous on its face as to what level of care is required to achieve “adequate supervision.” See
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`Ashbury Ctr. v. U.S. Dep’t of Health & Human Servs., 77 F. App’x 853, 857 (6th Cir. 2003); see
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`also Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 447–49 (7th Cir.
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`2010).
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`“The standard of care imposed by these ‘as is possible’ and ‘adequate supervision’
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`regulations has been consistently interpreted by the DHHS and federal courts as a ‘reasonableness’
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`standard.” Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457
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`(5th Cir. 2010). The DAB has interpreted § 483.25(h) to place “a continuum of affirmative duties
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`on a facility” to “determi

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