Medford Care Center, DAB No. 3040 (2021)

REMAND OF ADMINISTRATIVE LAW JUDGE DECISION

Medford Care Center (the Facility), a skilled nursing facility, appeals the March 30, 2018 Administrative Law Judge decision, Medford Care Center, DAB CR5060 (2018) (ALJ Decision), granting summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS).  The ALJ concluded that the material facts were undisputed and, as a matter of law, the Facility failed to comply substantially with three Medicare participation requirements based on its staff’s failure to administer two consecutive doses of an immunosuppressant medication to a resident.  The ALJ found the deficiencies rose to the immediate jeopardy level and upheld two civil money penalties (CMPs) – one for $8,999 per day for two days of immediate jeopardy, and the second for $505 per day for sixty-three days of noncompliance (Level G) for a total of $49,813.  The ALJ did not address a fourth alleged deficiency relating to the care of a different resident, concluding that the unaddressed deficiency was not necessary to support the CMPs.

For the reasons explained below, we conclude that there are genuine disputes of material fact as to whether the Facility’s alleged deficiencies were likely to cause serious injury, harm, impairment, or death to any resident, so that the ALJ’s entry of summary judgment on the issue of immediate jeopardy was improper.

Moreover, we find the question of substantial compliance – that is, whether the Facility’s alleged deficiencies had the “potential” to cause “more than minimal” harm to one or more residents – cannot be resolved on summary judgment due to unresolved evidentiary objections, uncertainty about the scope of the record evidence, and disputes of material fact. 

Finally, we conclude that the evaluation of the reasonableness of the CMPs is premature given our determination that summary judgment was improper.  Moreover, a review of the CMPs in this case, if necessary, requires consideration of the unaddressed fourth deficiency (and applicable regulatory factors).  Accordingly, we vacate the entry of summary judgment and remand this matter to the ALJ for further proceedings consistent with this decision.

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Legal Background

To participate in the Medicare program, a skilled nursing facility must be in “substantial compliance” with the participation requirements in 42 C.F.R. Part 483, subpart B.1   Social Security Act (Act) § 1819(h); 42 C.F.R. §§ 483.1, 488.400.  A skilled nursing facility is not in “substantial compliance” when it has a “deficiency” – that is, a failure to meet a participation requirement – that creates the potential for more than minimal harm to one or more residents.  42 C.F.R. § 488.301 (defining “substantial compliance” and “deficiency”).  The term “noncompliance,” as used in the applicable regulations (and in this decision), is synonymous with lack of substantial compliance.  Id. (defining “noncompliance”).

A skilled nursing facility’s compliance with Medicare participation requirements is verified through onsite surveys performed by state survey agencies.  Id. §§ 488.10(a), 488.11.  A state survey agency reports any deficiency (failure to meet a participation requirement) it finds in a statement of deficiencies.  Id. §§ 488.325(f)(1), 488.331(a).

The participation requirements at issue in this appeal, include the following:

• “A facility must immediately . . . consult with the resident’s physician . . . when there is . . . [a] need to alter treatment significantly (that is, a need to discontinue or change an existing form of treatment due to adverse consequences, or to commence a new form of treatment).”  42 C.F.R. § 483.10(g)(14)(i)(C).
• “The services provided or arranged by the facility, as outlined by the comprehensive care plan, must . . . [m]eet professional standards of quality.”  Id. § 483.21(b)(3)(i).
• “The facility must ensure that its . . . [r]esidents are free of any significant medication errors.”  Id. § 483.45(f)(2).

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CMS may impose enforcement remedies (such as CMPs) on a skilled nursing facility that is not in substantial compliance with one or more participation requirements.  Act § 1819(h)(2); 42 C.F.R. §§ 488.400, 488.402(b), (c), 488.406.  When CMS decides to impose a CMP for a skilled nursing facility’s noncompliance, it must consider various regulatory factors, including the “seriousness” of the noncompliance, in setting the amount of the CMP.  42 C.F.R. §§ 488.404(b), 488.438(f).  “Seriousness” is a function of the scope of noncompliance (whether it is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether it has created a “potential for . . . harm,” resulted in “actual harm,” or placed residents in “immediate jeopardy”).  Id. § 488.404(b).

The most severe noncompliance is that which puts one or more residents in “immediate jeopardy.”  See id. § 488.438(a)(1) (authorizing the highest per-day CMPs for immediate-jeopardy-level noncompliance); Woodland Oaks Healthcare Facility, DAB No. 2355, at 2 (2010) (citing authorities).  “Immediate jeopardy” means “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

When CMS imposes a per-day CMP for noncompliance at the immediate jeopardy level of severity, it must set the CMP amount within the “upper range” of $3,050 to $10,000 (as adjusted annually under 45 C.F.R. Part 102) per day.  Id. § 488.438(a)(1)(i).  A CMP in the “lower range” range of $50-$3,000 (as adjusted annually under 45 C.F.R. Part 102) per day may be imposed for noncompliance that does not place residents in “immediate jeopardy” but that either causes actual harm or creates the potential for more than minimal harm.  Id. § 488.438(a)(1)(ii).  A per-day CMP may accrue until the facility achieves substantial compliance or its provider agreement is terminated.  Id. § 488.454(a).

A skilled nursing facility may appeal the findings of noncompliance that led to the imposition of a remedy.  Id. §§ 488.408(g)(1), 498.3(b)(13).  The scope of review may include whether the amount of the CMP is reasonable.  See id. § 488.438(e)(3), (f); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629, at 2-3 (1997).

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Case Background2

On March 16, 2017, surveyors from the New Jersey Department of Health completed a survey of the Facility.  CMS Ex. 3, at 1.  The survey occurred during a six-week period from February 1, 2017, to March 16, 2017, and included four site visits.  P. Ex. 2, at 10.  The surveyors cited the Facility for deficiencies at the immediate jeopardy level based on its failure to administer two doses of Prograf, an immunosuppressant medication, prescribed for Resident #14.  CMS Ex. 1.  Prograf (the brand name for tacrolimus) is used in connection with kidney transplants to decrease the chance of rejection.  P. Ex. 2, at 11; CMS Ex. 20, at 2 (¶ 4).  Resident #14 was a kidney transplant recipient and his physician ordered that he receive Prograf twice daily – once in the morning and once in the evening.  P. Ex. 2, at 8; CMS Ex. 13, at 2; CMS Ex. 1, at 2-3.

The Facility ran out of Prograf on March 1, 2017.  CMS Ex. 21, at 5-6 (¶ 17).  Two of the Facility’s nurses failed to administer two scheduled doses of Prograf to Resident #14 on March 1, 2017 (8:00 p.m.) and March 2, 2017 (9:00 a.m.).  CMS Ex. 1, at 3.  Two days before the missed doses, one of the nurses had contacted the pharmacy to request a refill of Prograf and was informed that it would not be delivered until March 2.  Id.  At that time, neither nurse notified the nursing supervisor or Resident #14’s attending physician that the medication was not available and would not be administered as directed.  Id.

On March 2, 2017, the Facility’s staff notified Resident #14’s attending physician of the two missed doses of Prograf.  P. Ex. 2, at 11; CMS Ex. 12, at 1.  The attending physician did not alter Resident #14’s treatment but instructed the staff to give him one dose of his medication when it became available later that evening (March 2).  CMS Ex. 12, at 1.

The attending physician also spoke with the survey team on March 2, 2017.  CMS Ex. 16, at 73 (Surveyor Notes Worksheet).  According to the surveyor’s notes, the attending physician stated that Resident #14 was “never in any danger.”  Id.

The surveyors cited the Facility for the following deficiencies related to its failure to administer two consecutive doses of Prograf to Resident #14 on March 1 and March 2:

• The Facility was cited for immediate jeopardy under 42 C.F.R. § 483.10(g)(14) (Tag F157) for failing to timely notify the physician when Resident #14’s medication was not available and not administered.  CMS Ex. 1, at 1-3.

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• The Facility was cited for immediate jeopardy under section 483.21(b)(3)(i) (Tag F281) for failing to provide services meeting professional standards of quality when Resident #14’s medication was not administered according to physician orders and acceptable standards of nursing practice.  Id. at 12-14.
• The Facility was cited for immediate jeopardy under section 483.45(f)(2) (Tag F333) for failing to ensure residents are free of significant medication errors when Resident #14’s medication was not administered according to physician orders.  Id. at 34-35.

The surveyors noted in the statement of deficiencies that each of these deficiencies had the “potential to affect” all residents on Resident #14’s unit receiving or requiring “significant medication.”  Id. at 3, 13, 35.  The statement of deficiencies did not describe or define what the surveyors considered “significant medication,” other than Prograf.  CMS Ex. 1, at 2, 12, 34.

CMS imposed a CMP of $17,998 ($8,999 per day for two days) based on the immediate jeopardy determinations cited on March 1, 2017, and March 2, 2017.  CMS Ex. 3, at 1.  In addition, CMS imposed a CMP of $31,815 ($505 per day for sixty-three days) based on noncompliance from March 3, 2017, to May 4, 2017, for different deficiencies (not at the immediate jeopardy level) relating to the care of a different resident (Resident #15).  Id. at 1-2; see also CMS Ex. 1 at 25-34 (describing deficiencies under 42 C.F.R. §§ 483.24, 483.25(k)(1) (Tag F309) relating to Resident #15).  The total amount of the CMPs was $49,813.  CMS Ex. 3, at 1-2.

ALJ Proceedings and Decision

The Facility timely requested an ALJ hearing.  The ALJ entered an Acknowledgment and Pre-Hearing Order (Pre-Hearing Order), requiring each party to file a pre-hearing exchange, including a brief, proposed exhibits, proposed exhibit list, proposed witness list, and the written direct testimony of each proposed witness.  Pre-Hearing Order ¶¶ 3, 7.  The Pre-Hearing Order advised that a party may file a motion for summary disposition and that such a motion will be decided “according to the principles of Rule 56 of the Federal Rules of Civil Procedure and applicable case law.”  Id. ¶ 4.a.  The Pre-Hearing Order further advised that, if requested, both parties have “the right to cross-examine any witness” for whom the opposing party offered written direct testimony.  Id. ¶ 8.  Additionally, the Pre-Hearing Order advised that both parties have the right to file written objections to any proposed exhibits identified by the other party.  Id. ¶ 6.

In addition to the Pre-Hearing Order, the parties were provided with the Civil Remedies Division (CRD) Procedures (eff. Mar. 28, 2016), which state:  “Where a case is to be decided without an oral hearing, the ALJ will give a party the opportunity to object to the

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admission of documentary evidence offered as an exhibit by the opposing party.”  CRD Procedures at 16 (¶ 14(e)).  The CRD Procedures further state: “The ALJ determines the admissibility of evidence.  The ALJ is not bound by the Federal Rules of Evidence; however, the ALJ may apply the Federal Rules of Evidence where appropriate, for example, to exclude unreliable evidence.”  Id. at 19 (¶ 20); see also 42 C.F.R. § 498.61 (“The ALJ rules on the admissibility of evidence.”).

CMS filed a Pre-Hearing Brief and Motion for Summary Judgment (SJ Br.), along with twenty-two exhibits, an exhibit list, and witness list.  CMS submitted the written direct testimony of the state surveyors.  CMS Exs. 20, 21.  According to CMS, summary judgment was appropriate because “[t]here is no credible way that [the Facility] can support an argument” that Prograf is not a “significant medication,” it is undisputed Resident #14 was not administered Prograf consistent with physician orders, and it is undisputed that the physician was not notified that Prograf was unavailable and not administered.  SJ Br. at 3.

The Facility filed a Prehearing Brief and Brief in Opposition to CMS’s Motion for Summary Judgment (SJ Opp’n), along with five exhibits, an exhibit list, and witness list.  The Facility submitted, among other things, the written direct testimony of an expert witness (P. Ex. 1) and written direct testimony of the Facility’s administrator (P. Ex. 2).  The Facility included with its submission a letter signed by Resident #14’s attending physician (identified as a hearing witness), who wrote that the two missed doses of Prograf had not put Resident #14 in immediate jeopardy.  P. Ex. 2, at 11 (“I did not consider the two missed doses as a[n] immediate jeopardy to the resident.”).  He further reported that the incident required no medical intervention or follow up and had “absolutely no negative outcome.”  Id. at 12.  According to the attending physician, Resident #14’s kidney transplant was performed seven years ago, and the “most crucial time to administer” Prograf is within the first six months of the transplant.  Id. at 11.

The Facility’s expert witness, Anup Patel, M.D., is board certified in internal medicine and nephrology, has been a transplant nephrologist for Saint Barnabas Medical Center, Department of Renal and Pancreas Transplantation since 2004, and has served as the Clinical Director of the Transplant Department since 2010.  P. Ex. 1, at 1, 3-4, 8.  Based on his review of Resident #14’s records, Dr. Patel found that Resident #14 missed two doses of his immunosuppressant medication (tacrolimus) in March 2017.  Id. at 8.  Dr. Patel observed that Resident #14’s tacrolimus level was within the therapeutic range as of March 30, 2017, and a progress note from April 2017 indicated that he maintained “excellent transplant function.”  Id.  Dr. Patel opined that missing two doses of tacrolimus (Prograf) more than six years after a kidney transplant “did not have any short-term impact on this patient (ie – acute rejection or acute kidney injury) and would not have any long-term impact on the patient’s clinical status.”  Id.  Dr. Patel further opined that “it was not likely to cause serious injury, harm, impairment or death to a

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facility resident,” noting that immunosuppression “is often intentionally minimized several years after” a transplant.  Id.

In its brief, the Facility argued that summary judgment was inappropriate because material facts are in dispute and a “full hearing” will demonstrate that:  (i) the Facility was in substantial compliance with applicable participation requirements; (ii) the finding of immediate jeopardy was clearly erroneous; and (iii) the CMP was unreasonable.  SJ Opp’n at 2, 14.  The Facility argued, based on evidence from the attending physician and expert witness, that “Resident #14 was not actually harmed or put at risk of serious injury, harm, impairment or death.”  Id. at 6.  The Facility further argued that the issue of potential harm is an “open issue of fact, credibly disputed” by the attending physician and expert witness, and the Facility “must be given the opportunity to cross-examine CMS witnesses on these vital points.”  Id.  The Facility noted that the attending physician had been advised of the missed doses of Prograf on March 2, 2017, and he determined there was no need to alter Resident #14’s treatment.  Id. at 7.  Moreover, the Facility argued that its expert witness had opined that the two missed doses “were not likely to cause serious injury, harm, impairment or death to a facility resident.”  Id. at 7-8, 11.  In addition, the Facility argued that it was in substantial compliance with all participation requirements concerning Resident #15.  Id. at 9-10.

The Facility also filed written objections to CMS Exhibits 4, 5, and 18 “on the grounds that they are prejudicial and unreliable hearsay.”  Pet. Objection at 1.  CMS Ex. 4 is a printout of online information at MedlinePlus.gov regarding the use of tacrolimus.  CMS Ex. 5 is a printout of online information at Kidney.org (website of the National Kidney Foundation) about immunosuppressants generally.  CMS Ex. 18 is a printout of online information at Emedicine.medscape.com concerning pain assessments in persons with cognitive impairments.3   The Facility argued, among other things, that CMS Exs. 4 and 5 “lack any citations to sources and are wholly unsubstantiated,” pertain only to immunosuppressants generally (not patients several years post-transplant), and the assertions made by the unidentified authors of these internet postings are not supported by expert testimony or subject to cross-examination.  Pet. Objection at 2.

On March 30, 2018, without ruling on the admissibility of any exhibits or receiving any exhibits into the record, the ALJ issued a decision granting summary judgment in favor of CMS, concluding that the Facility failed to comply substantially with Medicare participation requirements at a level of noncompliance that placed residents of the Facility in immediate jeopardy.  ALJ Decision at 1-2.  The ALJ’s decision was limited to the three deficiencies identified by CMS in connection with the Facility’s failure to administer two doses of Prograf to Resident #14.  Id. at 2-3.  The ALJ made no

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determination about the alleged deficiencies relating to Resident #15, but affirmed both CMPs (totaling $49,813), concluding that “the immediate jeopardy level findings amply justify the remedies” imposed by CMS.  ALJ Decision at 1, 2 n.1.

The ALJ found the undisputed facts “plainly establish” that the Facility “failed to comply” with 42 C.F.R. §§ 483.10(g)(14) (notification of changes/physician consultation), 483.21(b)(3)(i) (professional standards), and 483.45(f)(2) (significant medication errors).  ALJ Decision at 2-3.  The ALJ found there is no dispute that:  (i) the Facility’s staff failed to administer the required doses of Prograf to Resident #14 on the evening of March 1 and the morning of March 2 because the pharmacy had run out of the medication; (ii) the Facility’s staff knew as early as February 27 that the pharmacy was out of Prograf and an additional supply would not be delivered until March 2; and (iii) the Facility’s staff failed to consult with Resident #14’s treating physician before March 1, or on March 1 or 2, concerning their failure to administer the medication.  Id. at 3.4  The ALJ further found that the Facility’s staff violated its own policies governing the administration of medication.  Id. at 3.5   The ALJ then stated:  “The only reasonable inference that I can draw from the staff’s passivity despite the missing medication is that the staff was uneducated as to the purpose of the medication and the possible downside of not administering it as prescribed.”  Id. at 4 (emphasis added).  The ALJ Decision alludes to “the potential issues arising from failure to administer Prograf to Resident #14 pursuant to his physician’s orders,” but does not explain or describe the effect of not administering two doses of Prograf as directed.  Id.6

In responding to the Facility’s argument that Resident #14 suffered no harm based on the statements of the attending physician and expert nephrologist, the ALJ found the physician and expert medical opinions immaterial.  ALJ Decision at 4.  According to the ALJ, the issue is not whether Resident #14 was “actually harmed,” but the “likelihood of serious, injury, harm or death to residents of Petitioner’s facility resulting from Petitioner’s staff’s disregard of policies and governing regulations.”  Id.  The ALJ found the failure by the Facility’s staff to comply with its “policies and regulatory requirements

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in this case evidences a generalized incomprehension by the staff about what its duties are in circumstances like this.”  Id. at 5 (emphasis in original).  The ALJ wrote:

The only reasonable inference that I can draw from the failure to consult with the physician and to seek out alternative medication sources in the case of Resident #14 is that the staff was not sensitized, either to its duties and responsibilities, or to the potential harm that might be caused by not delivering medication without consultation with the prescribing physician.  In other words, Resident #14 was not the only vulnerable resident at Petitioner’s facility.  Potentially, any resident similarly situated would be in peril.

Id. at 5. 

The ALJ concluded that the undisputed material facts “plainly support CMS’s determination of immediate jeopardy level noncompliance.”  Id. at 5 (“I cannot infer from these facts anything less than that.”).  The ALJ found, without citing to any evidence, that “[t]he likelihood that residents of Petitioner’s facility would be seriously harmed or suffer worse consequences from the staff’s indifference to regulatory requirements and Petitioner’s own policies was overwhelming.”  Id.  The ALJ further found that “staff blatantly disregarded the treating physician’s orders and failed to consult with the physician after having done so” – “a recipe for disaster with elderly, frail, sick, and dependent residents.”  Id.  The ALJ made no finding about actual harm to Resident #14, and never specified what harm was likely to result from the failure to administer two doses of Prograf to any resident.  Id. at 4-5.

Board Proceedings

The Facility challenged the entry of summary judgment with a timely-filed request for review (RR) of the ALJ Decision.  The Facility reiterates before the Board many of the same arguments it made before the ALJ and further contends there is “no support” for the ALJ’s determination that there was a “generalized incomprehension” by the Facility’s staff about its duties.  RR at 6, 8, 9, 10, 12.  The Facility also points out that, contrary to the ALJ’s conclusion, the Facility consulted with the attending physician about the missed doses of Prograf on March 2, 2017, and was told there was no need to alter Resident #14’s treatment.  RR at 8 (citing P. Ex. 2, at 11-12).  The Facility contends the ALJ should have denied summary judgment because, at a minimum, there is a factual dispute as to whether the Facility’s staff “caused any potential for harm” to Resident #14, and a full hearing “would demonstrate that the immediate jeopardy determination was clearly erroneous as supported by the [Facility’s] expert review.”  Id. at 13 (emphasis in original).  The Facility further argues that the ALJ should have reviewed the deficiency

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allegations involving Resident #15, and that the CMP was unreasonable and should not have been imposed retroactively.  Id. at 10, 13-14.

CMS filed a brief in opposition (CMS Br.) arguing that the ALJ Decision should be affirmed.  CMS contends that the “fatal flaw” in the Facility’s argument is its contention that to sustain the immediate jeopardy determination there must be proof that the Facility “either caused harm or raised the likelihood of serious harm in this case.”  CMS Br. at 8 (emphasis in original).  According to CMS, “this case” is not only about Resident #14, and there is a “causal connection” between the noncompliance in Resident #14’s case and the “serious threat of injury” to other residents.  Id.  According to CMS, the ALJ correctly concluded that the Facility’s staff’s “indifference to regulatory requirements and facility policies made the likelihood that other [Facility] residents would be seriously harmed or suffer worse consequences ‘overwhelming.’”  Id.  CMS made no argument about the alleged deficiencies regarding Resident #15 and did not address the ALJ’s decision to uphold both CMPs based only on the immediate-jeopardy-level noncompliance relating to Resident #14.7

The Facility filed a reply reiterating the same arguments it previously made.  It also filed a separate request for oral argument, asserting that:  (i) there is no support in the record for the contention that errors with regard to the care of Resident #14 were systemic, putting other residents at risk of serious harm; and (ii) Resident #14 “was never harmed or put at risk of serious harm.”8

Standard of Review

We review an ALJ’s grant of summary judgment de novo.  Avalon Place Kirbyville, DAB No. 2569, at 6 (2014).  If we determine that summary judgment is not appropriate, we may remand the case to the ALJ for further proceedings.  See 42 C.F.R. § 498.88; Shiloh First Health Care, Inc., DAB No. 2974, at 1 (2019) (vacating summary judgment and remanding for further proceedings consistent with the Board’s decision).

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Analysis

Summary judgment is appropriate when the record shows “there is no genuine dispute as to any material fact” and the moving party “is entitled to judgment as a matter of law.”  Fed. R. Civ. P. 56(a); see also Kingsville Nursing & Rehab Ctr., DAB No. 2234, at 3 (2009).  In evaluating a summary judgment motion, the “tribunal must view the entire record in the light most favorable to the nonmoving party, drawing all reasonable inferences from the evidence in that party’s favor.”  Pepper Hill Nursing & Rehab. Ctr., LLC, DAB No. 2395, at 4 (2011) (citing Madison Health Care, Inc., DAB No. 1927, at 3-7 (2004)).  In deciding a motion for summary judgment, the tribunal must not “‘make credibility determinations, weigh the evidence, or decide which inferences to draw from the facts,’ as would be proper when sitting as a fact-finder after a hearing, but instead should ‘construe the record in the light most favorable to the nonmovant and avoid the temptation to decide which party’s version of the facts is more likely true.’”  Kingsville at 8-9 (brackets omitted) (quoting Payne v. Pauley, 337 F.3d 767, 770 (7th Cir. 2003)).

A party may demonstrate the absence of a genuine dispute by presenting specific evidence on a particular issue or by pointing out “an absence of evidence to support the non-moving party’s case.”  Celotex Corp. v. Catrett, 477 U.S. 317, 323, 325 (1986).  To overcome an adequately supported motion for summary judgment, the “non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law.”  Kingsville at 3 (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586, n.11 (1986); Celotex, 477 U.S. at 322).  When a skilled nursing facility is the non-moving party, it need not show that it has met its burden of persuasion on ultimate issues (e.g., whether it was in substantial compliance) in order to defeat a motion for summary judgment; rather, the facility need only show that “a rational trier of fact could find for the facility under the most favorable, reasonable construction of the proffered evidence.”  St. Catherine’s Care Ctr. of Findlay, Inc., DAB No. 1964, at 10 (2005) (emphasis in original).

We vacate the entry of summary judgment in this case because the ALJ did not view the evidence in the light most favorable to the Facility, did not draw all reasonable inferences in favor of the Facility, and erroneously concluded that no material facts are in dispute.  We express no opinion about the relative weight of the parties’ evidence and conclude only that summary judgment in favor of CMS was inappropriate given the existence of genuine disputes of material fact and unresolved evidentiary objections.

1.       Summary judgment is inappropriate on the issue of immediate jeopardy.

As noted above, the ALJ did not separately determine whether any cited deficiency created a potential to cause more than minimal harm – the basis for finding a lack of substantial compliance.  See supra at 8 n.6.  Rather, the ALJ addressed the question of

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substantial compliance only in the context of evaluating the issue of immediate jeopardy.  ALJ Decision at 4 (“[T]he issue is the likelihood of serious injury, harm, or death to residents of Petitioner’s facility resulting from Petitioner’s staff’s disregard of policies and governing regulations.”).  For that reason, we address the issue of immediate jeopardy first.

Immediate jeopardy is defined as a “situation in which the [facility’s] noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301 (italics added).  Thus, immediate jeopardy exists in either of “two general circumstances.”  See Daughters of Miriam Ctr., DAB No. 2067, at 8 (2007).  First, immediate jeopardy exists if the facility’s “noncompliance has caused death or ‘serious’ harm to one or more residents.”  Id.9   Second, immediate jeopardy exists if the facility’s “noncompliance is or was ‘likely to cause’ death or serious harm.”  Id. 

The Board has explained that the term “likely” means “probable” and “reasonably to be expected,” and “suggest[s] a greater degree of probability that a particular event will occur than the terms ‘possible’ or ‘potential.’”  Id. at 10 (citing Webster’s New World Dictionary (2nd college ed.); The American Heritage Dictionary of the English Language (4th ed.); Black’s Law Dictionary (5th ed.)); see also Innsbruck HealthCare Ctr., DAB No. 1948, at 5 (2004) (“[A] determination of immediate jeopardy requires a showing that serious harm is likely, not merely that a risk of serious harm exists.”).  “Determining whether a deficiency is likely to cause serious harm often entails the application of professional medical or nursing judgment or expertise.”  Oak Ridge Ctr., DAB No. 2913, at 29 (2018).  Moreover, a finding of immediate jeopardy made by CMS must be upheld unless it is “clearly erroneous.”  Id. (citing 42 C.F.R. § 498.60(c)(2)).

Upholding an immediate jeopardy determination on summary judgment is inappropriate if there are genuine issues of material fact as to whether the facility’s noncompliance caused, or was likely to cause, serious harm.  See Franklin Care Ctr., DAB No. 2869, at 11 (2018) (vacating summary judgment on question of immediate jeopardy where facility, through the statements of its expert witness, “raised a genuine dispute of material fact as to the assessment of the likelihood of and seriousness of the harms created” by the facility’s noncompliance); Innsbruck at 8 (vacating summary judgment on immediate jeopardy issue because expert testimony proffered by the facility demonstrated “a genuine dispute of fact over the assessment of the degree of risk [of harm] to the residents” from the facility’s noncompliance); see also Oak Ridge at 29-30 (“Because medical or nursing judgment may inform CMS’s assessment of a deficiency’s potential impact on residents’ well-being, expert opinion proffered by the [facility] on that topic

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may suffice, in appropriate circumstances, to create a genuine factual dispute precluding summary judgment.”).  Indeed, an ALJ “cannot properly evaluate” whether an immediate jeopardy finding is clearly erroneous “without first resolving material disputes of fact as to what the facts were and whether they were different than those to which the surveyors . . . applied their expert judgment.”  See Franklin Care, DAB No. 2869, at 9.  

Here, the ALJ did not find, and CMS never argued, that the Facility’s deficiencies relating to Resident #14 caused any actual harm.  ALJ Decision at 4 (“The issue here is not whether Resident #14 was actually harmed by the failure to administer Prograf to him.  Rather, the issue is the likelihood of serious injury, harm, or death to residents of Petitioner’s facility resulting from Petitioner’s staff’s disregard of policies and governing regulations.”).10   The ALJ found the “undisputed material facts plainly support CMS’s determination of immediate jeopardy,” and that he “cannot infer from these facts anything less than that.”  Id. at 5.  According to the ALJ, the “likelihood that residents of Petitioner’s facility would be seriously harmed . . . was overwhelming.”  Id.  CMS contends the ALJ Decision should be affirmed based on the likelihood of serious harm, not just to Resident #14, but to all of the Facility’s residents.  CMS Br. at 2, 3-4, 6 (“The real issue is the likelihood of serious harm to all of [the Facility’s] residents resulting from the staff’s disregard of facility policies and regulations.”), 8 (“‘[T]his case’ is not only about Resident #14, nor really is any case where a facility is cited based on a set of facts revolving around one resident.”).11

As an initial matter, the ALJ’s conclusion that the likelihood of serious harm “was overwhelming” suggests the ALJ improperly weighed the competing evidence.  “[O]n summary judgment, it is not appropriate to consider the credibility of the witnesses or the weight to be accorded to competing evidence.”  Shiloh at 6.  Rather, an ALJ “should ‘construe the record in the light most favorable to the nonmovant and avoid the temptation to decide which party’s version of the facts is more likely true.’”  Kingsville at 8-9 (brackets omitted) (quoting Payne v. Pauley, 337 F.3d at 770).  Thus, the immediate jeopardy determination cannot be sustained on summary judgment even if the “weight of the evidence” supported it; the question is whether CMS, as the moving party,

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demonstrated the absence of a genuine dispute of material fact.  See Oak Ridge at 30.  We conclude it did not.   

The Facility proffered expert testimony demonstrating a genuine dispute of fact on the issue of whether the three cited deficiencies relating to the Facility’s failure to notify the physician and administer two doses of Prograf (Tags F157, F281, F333) were likely to cause serious harm.  Dr. Patel, who is Board Certified in Internal Medicine and Nephrology, provided written direct testimony opining that missing two doses of tacrolimus (Prograf) did not have any impact on Resident #14 and “was not likely to cause serious injury, harm, impairment or death to a facility resident.”  P. Ex. 1, at 8.  Similarly, the attending physician provided a letter stating that he spoke to the surveyors on March 2, 2017, and told them he did not consider the two missed doses of Prograf as putting Resident #14 in “immediate jeopardy.”  P. Ex. 2, at 11, 12.  The attending physician further explained that he was notified by staff of the two missed doses, and he recommended no change in treatment based on the missed doses.  Id. at 11-12.  This evidence, viewed in the light most favorable to the Facility, directly refutes CMS’s contention that the staff’s failure to immediately notify the physician and failure to administer Prograf to Resident #14 as prescribed created an immediate jeopardy situation.  CMS Br. at 2.

Further, the evidence CMS and the surveyors relied on to support their immediate jeopardy determination (CMS Exs. 4 and 5) falls short of demonstrating that missing two doses of Prograf within 24 hours is likely to cause serious harm.  See CMS Ex. 4 (MedlinePlus.gov); CMS Ex. 5 (Kidney.org).12  Information from these exhibits was quoted in the statement of deficiencies to establish the risk of harm associated with not taking Prograf as directed.  CMS Ex. 1, at 3-5, 35-37.  In addition, both surveyors relied on these exhibits in their respective declarations.  See CMS Ex. 20, at 4-5 (¶ 12), 7 (¶ 19), 8 (¶ 21); CMS Ex. 21, at 6-7 (¶ 19), 8-9 (¶ 26).  Neither surveyor purported to base their opinions about the effect of missing two doses of Prograf on their personal knowledge or experience.  Instead, referring to CMS Exs. 4 and 5, one surveyor opined that missing even a single dose of Prograf “could cause rejection,” and that Prograf “can only prevent rejection” if “taken exactly as directed.”  CMS Ex. 20, at 7 (¶ 19), 8 (¶ 21).  The other surveyor, relying on the same two exhibits, made the same points in substantially the same language.  CMS Ex. 21, at 6-7 (¶ 19), 8-9 (¶ 26).

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The exhibits themselves, however, paint a less dire picture.  The Medline Plus website excerpt advises patients who “forget” to take a dose of tacrolimus to “[t]ake the missed dose as soon as you remember it.”  CMS Ex. 4, at 3-4.  But, “if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.”  Id. at 4.  The excerpt does not advise patients to contact their physician if they miss a dose and contains no information about the likelihood of serious harm or death if a patient were to miss two doses within 24 hours.  The excerpt advises only that a patient should not discontinue tacrolimus “without talking to your doctor.”  Id. at 2.

The National Kidney Foundation website excerpt provides information about immuno-suppressants generally and is not specific to tacrolimus.  CMS Ex. 5.  The excerpt explains that there are two classes of immunosuppressants:  (1) induction drugs, which are powerful antirejection medicine used at the time of a transplant; and (2) maintenance drugs, like tacrolimus, which are used for the long term to prevent rejection.  Id. at 1.  It warns, without specifying whether it is referring to induction drugs or maintenance drugs, that “missing a single dose may make it more likely for you to have a rejection.”  Id. at 2 (emphasis added).  Patients are told not to skip a dose of an immunosuppressant unless advised by your doctor or you are having blood drawn for lab work.  Id.  The excerpt recognizes that “forgetting a dose is easy to do,” and advises patients who miss a dose to “[t]ake it as soon as you remember and call your doctor,” but “[i]f it is time for the next dose, do not take a double dose.”  Id.  It does not warn patients that missing a single dose (or two doses) of tacrolimus is likely to cause serious harm and contains no information about the likelihood of serious harm from missed doses.  Viewing the evidence in the light most favorable to the Facility, and drawing all reasonable inferences from the evidence in the Facility’s favor, there is unquestionably a genuine dispute of fact as to whether the staff’s failure to consult the attending physician and administer two doses of Prograf as directed was likely to cause any resident serious harm or death.

Furthermore, the ALJ drew unfavorable inferences against the Facility in expanding the scope of the alleged deficiencies beyond their connection to Resident #14:

[T]he failure by Petitioner’s staff to comply with Petitioner’s policies and regulatory requirements in this case evidences a generalized incomprehension by the staff about what its duties are in circumstances like this.  The only reasonable inference that I can draw from the failure to consult with the physician and to seek out alternative medication sources in the case of Resident #14 is that the staff was not sensitized, either to its duties and responsibilities, or to the potential harm that might be caused by not delivering medication without consultation with the prescribing physician.  In other words, Resident #14 was not the only vulnerable resident at

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Petitioner’s facility.  Potentially, any resident similarly situated would be in peril.

. . .

The likelihood that residents of Petitioner’s facility would be seriously harmed or suffer worse consequences from the staff’s indifference to regulatory requirements and Petitioner’s own policies was overwhelming.  In this case, the staff blatantly disregarded the treating physician’s orders and failed to consult with the physician after having done so.  That is a recipe for disaster with elderly, frail, sick, and dependent residents.

ALJ Decision at 5.

In these passages, the ALJ inferred that because the Facility’s staff failed to consult with the attending physician about the shortage of Prograf and failed to administer Prograf to Resident #14 as directed, they likely made the same errors in the care and treatment of other residents and that, according to the ALJ, demonstrated immediate-jeopardy-level noncompliance.  The ALJ essentially drew two adverse inferences against the Facility from the evidence relating to Resident #14.  First, the ALJ inferred that the incident involving Resident #14 was not isolated, but part of a larger systemic problem involving the staff’s “generalized incomprehension” and “indifference” to regulatory requirements and policies.  Second, building on the first inference, the ALJ inferred that this systemic problem affected all residents and was likely to result in serious harm or death.  Even if these inferences could be reasonably drawn from the evidence (which is questionable), they “cannot be the basis for granting summary judgment against [the Facility] because, at the summary judgment stage, the ALJ may draw only reasonable inference[s] favorable to the non-movant.”  Oak Ridge at 33 (vacating summary judgment on the issue of immediate jeopardy where ALJ made adverse inferences about the nursing staff’s “persistent inability” or “unwillingness” to comply with physician orders) (emphasis in original).

Moreover, the ALJ did not point to any undisputed evidence that the Facility’s nurses routinely disregarded or failed to carry out other medication orders or regularly failed to consult with physicians in other circumstances.  As the Facility pointed out, the survey involved four site visits over a six-week period and the surveyors reported no similar violations to support the ALJ’s determination.  RR at 6 (citing P. Ex. 2, at 10).  Absent such evidence (and given the Facility’s expert testimony), a trier of fact could reasonably conclude that the deficiencies relating to Resident #14 amounted to a single incident that caused no actual harm and was not likely to cause serious harm or death to any resident.  Cf. Spring Meadows Health Care Ctr., DAB No. 1966, at 37-38 (2005) (concluding that immediate jeopardy determination was clearly erroneous because CMS failed to show

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that facility’s handling of particular incident “reflected a fundamental or systemic misunderstanding” of its regulatory obligations or that staff “had shown an inability to comply with reporting and investigation requirements under other circumstances”).13

Our conclusion that summary judgment must be vacated does not imply that the Facility has demonstrated that CMS’s immediate jeopardy determination was clearly erroneous.  We conclude only that a trier of fact cannot, at this stage, determine whether the immediate jeopardy determination is clearly erroneous without affording the Facility an opportunity for a hearing and resolving factual disputes, including evidentiary objections, that bear upon the validity of CMS’s immediate jeopardy determination.14

2.       We are unable to resolve on summary judgment whether the Facility was not in substantial compliance with any participation requirement because the ALJ made no determination about the evidence in the record. 

Having determined that the immediate jeopardy determination cannot be sustained on summary judgment, we next consider whether CMS’s findings concerning the Facility’s alleged noncompliance with 42 C.F.R. §§ 483.10(g)(14) (notification of changes/physician consultation), 483.21(b)(3)(i) (professional standards), and 483.45(f)(2) (significant medication errors) could nevertheless be sustained on summary judgment.15   A skilled nursing facility is “considered to be out of substantial compliance if the deficiency either results in actual harm to a resident or poses a risk of more than minimal harm to resident health or safety.”  Libertyville Manor Rehab. & Healthcare

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Ctr., DAB No. 2849, at 17 (2018) (emphasis in original, citations omitted); see also Agape Rehab. of Rock Hill, DAB No. 2411, at 13-14 (“[T]he potential for more than minimal harm is the basis for finding noncompliance.”).  Since CMS presented no evidence of actual harm to Resident #14, the relevant question is whether the cited deficiencies had the potential for more than minimal harm.  We are unable to determine on summary judgment whether the Facility was not in substantial compliance with any participation requirement because there are unresolved evidentiary objections and the ALJ made no determination about the scope of the record evidence. 

The ALJ wrote that because he found “no disputed material facts,” it was unnecessary to rule on the admissibility of any exhibits and he declined to “receive” any of the parties’ exhibits “into the record.”  ALJ Decision at 2.  The Board has long held that this approach to summary judgment is problematic.  See, e.g., Illinois Knights Templar Home, DAB No. 2274, at 5-6 (2009).  The Board has nevertheless noted that, “while an ALJ is required to review all proposed exhibits submitted in support of or in opposition to a motion for summary judgment in order to determine whether there is a material dispute of fact precluding summary judgment, the ALJ is not required to admit those exhibits into the record in order to conduct this review and make this determination.”  Univ. of Tex. MD Anderson Cancer Ctr., DAB No. 2927, at 18 (2019), rev’d and remanded on other grounds, 985 F.3d 472 (5th Cir. 2021).  “Such exhibits . . . are properly treated as an offer of proof that may be evaluated if necessary to determine whether a genuine issue of material fact exists in considering a motion for summary judgment.”  Id. (internal quotation marks and citations omitted).  This analysis, however, presumes there are no outstanding evidentiary objections and no questions about the admissibility of exhibits proffered by the parties.  Thus, in some cases, the Board has affirmed summary judgment even when the ALJ declined to “admit” the parties’ exhibits because there were no unresolved evidentiary objections and the Board was able to determine, as part of its de novo review, that the proffered exhibits created no genuine issue of material fact.  See, e.g., Blair Allen Nelson, M.D., DAB No. 3024, at 5 n.6 (2020); Arkansas Health Group, DAB No. 2929, at 5 n.3 (2019).

This case is different.  The Pre-Hearing Order specified that any motions for summary disposition would be decided “according to the principles of Rule 56 of the Federal Rules of Civil Procedure.”  Pre-Hearing Order ¶ 4.a.  Rule 56 provides that “[a] party may object that the material cited to support or dispute a fact cannot be presented in a form that would be admissible in evidence.”  Fed. R. Civ. P. 56(c)(2).  The Pre-Hearing Order and CRD Procedures further specified that the parties may object to the opposing party’s exhibits and that the ALJ would rule on the admissibility of evidence.  See supra at 5-6. 

Objections to the admissibility of evidence cited to support or dispute a material fact, however, must be resolved to properly evaluate a motion for summary judgment.  Indeed, summary judgment is only appropriate “when the record shows that there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of

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law.”  Kingsville at 3 (emphasis added); see also Fed. R. Civ. P. 56(c)(1) (“A party asserting that a fact cannot be or is genuinely disputed must support the assertion by . . . citing to particular parts of materials in the record.” (emphasis added)).  “In deciding a summary judgment motion, a tribunal must view the entire record in the light most favorable to the nonmoving party, drawing all reasonable inferences from the evidence in that party’s favor.”  Pepper Hill Nursing at 4 (emphasis added).  We are unable to engage in the requisite summary judgment analysis because the ALJ did not determine whether CMS Exs. 4 and 5 are admissible and did not “receive” any exhibits into the record.

Before the ALJ, the Facility objected to the admissibility of CMS Exs. 4 and 5 arguing that they were unsubstantiated, prejudicial, and unreliable.  See supra at 7.  The information in CMS Exs. 4 and 5 was quoted in the statement of deficiencies, and CMS relied on these exhibits to establish that failing to administer two doses of Prograf and not notifying the physician created a risk of harm.  See supra at 14.  If these exhibits are not admissible, then it is unclear what, if any, evidence would support a finding that the cited deficiencies relating to Resident #14 had the potential for more than minimal harm.  We express no view on whether CMS Exs. 4 and 5 are admissible (or whether the information contained therein could be presented in an admissible form) and decline to resolve the evidentiary objections made before the ALJ.  We decide only that due to uncertainty about the scope of the record evidence, we are unable to sustain on summary judgment any finding regarding the Facility’s noncompliance.  Thus, this matter must be remanded for consideration of all factual issues relevant to the Facility’s alleged deficiencies under 42 C.F.R. §§ 483.10(g)(14), 483.21(b)(3)(i), and 483.45(f)(2).16  On remand, the ALJ should consider the admissibility of all exhibits, including CMS Exs. 4 and 5.  See Shiloh, DAB No. 2974, at 7 n.6.

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3.       The ALJ may determine, on remand, whether the CMPs are reasonable, including the CMP imposed in connection with the unaddressed deficiencies relating to Resident #15.

The Facility argues that the total CMP amount ($49,813) is unreasonable because the Facility:  (i) does not have a history of noncompliance; (ii) the cited deficiencies were isolated; and (iii) it acted “appropriately and expeditiously” in addressing each deficiency once notified.  RR at 14.  The Facility further contends the second CMP ($505 per day from March 3, 2017, to May 4, 2017) was an erroneous “retroactive” penalty because the Facility was not notified of the continued deficiencies until April 16, 2017.  RR at 4, 14.

In cases involving CMPs imposed on a per day basis, there are three potential issues to be addressed by an ALJ:  (i) was there a basis for imposing any CMP (i.e., was the facility noncompliant with participation requirements); (ii) what was the duration of the period of noncompliance; and (iii) was the amount of the CMP reasonable?  See W. Care Mgmt. Corp., DAB No. 1921, at 20 (2004).  In light of our decision to vacate the entry of summary judgment, it would be premature to rule at this stage on the Facility’s arguments challenging the total CMP amount. 

We note, however, that this case involved the imposition of two separate CMPs for different noncompliance findings relating to the care of two different residents.  First, CMS imposed a two-day CMP of $17,998 ($8,999 per day) based on the immediate jeopardy determinations cited on March 1, 2017 and March 2, 2017, relating to Resident #14.  CMS Ex. 3, at 1 (citing Tags F157, F281, F333).  Second, CMS imposed a CMP of $505 per day for 63 days of non-immediate-jeopardy-level noncompliance relating to the treatment of Resident #15.  Id. at 1-2 (citing Tag F309).  The combined CMPs totaled $49,813.  Id. at 1-2.

The ALJ made no determination about the alleged deficiencies relating to the treatment of Resident #15 (Tag F309 - 42 C.F.R. §§ 483.24, 483.25(k)(1)), but affirmed the total CMP amount, concluding that “the immediate jeopardy level findings amply justify the remedies” imposed by CMS.  ALJ Decision at 2 n.1.  This conclusion is wrong as a matter of law.  Two days of noncompliance at the immediate jeopardy level do not justify a CMP in the amount of $49,813.17   Here, CMS imposed a penalty of $8,999 per day for two days of noncompliance at the immediate jeopardy level for the deficiencies relating to Resident #14 (Tags F157, F281, and F333).  Thus, the maximum CMP the ALJ could sustain based on these deficiencies would be $17,998.

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The ALJ apparently assumed the deficiencies relating to Resident #14 continued at a level below immediate jeopardy after March 2, 2017; but, CMS never made that determination (see CMS Ex. 3) and never argued in its briefing (before the ALJ or the Board) that the $505 per day CMP (for 63 days) should be affirmed based only on the deficiencies relating to Resident #14.  Thus, in order to sustain the second CMP, consideration of the deficiencies relating to the treatment of Resident #15 (Tag F309) would need to be addressed on remand.  See W. Care Mgmt. at 21-22 (holding that ALJ erred in concluding that unaddressed deficiencies were immaterial because CMPs could not be sustained without finding noncompliance on all or a significant number of unaddressed deficiencies).  We agree with the Facility’s contention that the deficiencies relating to Resident #15 (Tag F309) “should have been substantively reviewed by the ALJ.”  RR at 10.

Finally, with respect to the Facility’s argument that CMS improperly imposed a “retroactive” penalty (RR at 14), we do not reach that issue for the reasons already stated; however, we remind the parties that ALJ or Board review of a penalty amount’s reasonableness must be based on evidence relating to the factors specified in or cross-referenced by 42 C.F.R. § 488.438(f).  See 42 C.F.R. § 488.438(e)(3), (f); Crawford Healthcare & Rehab., DAB No. 2738, at 19 (2016); Life Care Ctr. of Tullahoma, DAB No. 2304, at 63-64 (2010) (rejecting petitioner’s arguments challenging CMP amount that were not framed in terms of the relevant regulatory factors), aff’d, 453 F. App’x 610 (6th Cir. 2011).

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Conclusion

We vacate the ALJ Decision on summary judgment and remand for further proceedings consistent with this decision.  On remand, the ALJ should address all unresolved evidentiary objections, determine the admissibility of the parties’ exhibits, and develop the record as needed.  The ALJ should determine whether the Facility was not in substantial compliance with the participation requirements that led to the imposition of CMPs.

If the ALJ concludes that the Facility was not in substantial compliance with the requirements at 42 C.F.R. §§ 483.10(g)(14), 483.21(b)(3)(i), and/or 483.45(f)(2), the ALJ should determine whether CMS’s immediate jeopardy determination is clearly erroneous and whether the amount of the CMP imposed in connection with these alleged deficiencies is reasonable. 

If the ALJ concludes that the Facility was not in substantial compliance with the requirements at 42 C.F.R. §§ 483.24 and/or 483.25(k)(1), the ALJ should address the Facility’s arguments relating to the duration of the noncompliance and determine whether the amount of the CMP imposed in connection with these alleged deficiencies is reasonable.  

The ALJ may take any further action not inconsistent with this decision.

1. In October 2016, CMS issued a final rule that amended the Medicare participation requirements for long‑term care facilities.  See Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016).  In July 2017, CMS made technical corrections to some of the amended Medicare participation requirements; however, none of those technical corrections affected the participation requirements at issue here.  See 82 Fed. Reg. 32,256 (July 13, 2017).  Our analysis is based on the regulations in effect in March 2017, the month in which the state surveyors completed the survey that led to CMS’s determination of noncompliance.  See Carmel Convalescent Hosp., DAB No. 1584, at 2 n.2 (1996) (applying regulations in effect on the date of the survey and resurvey).
• back to note 1
2. The background information is drawn from the exhibits submitted by the parties and is provided for context and background only.  It is not intended to represent factual findings.  Factual findings will be made by the ALJ on remand.
• back to note 2
3. CMS Ex. 18 pertains to alleged deficiencies relating to the skin tear treatment of Resident #15.
• back to note 3
4. Contrary to the ALJ’s conclusion, there is evidence that the Facility’s staff consulted with Resident #14’s attending physician on March 2, 2017.  See P. Ex. 2, at 11; CMS Ex. 12, at 1.  The ALJ should consider this evidence on remand in connection with the analysis of the alleged deficiency under section 483.10(g)(14).
• back to note 4
5. The ALJ Decision is not clear as to which participation requirement(s) this finding relates, but we assume it relates to all of them.
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6. The potential for more than minimal harm is the basis for finding noncompliance (i.e., not in substantial compliance) with a participation requirement.  See supra at 2; Agape Rehab. of Rock Hill, DAB No. 2411, at 13-14 (2011) (citing 42 C.F.R. § 488.301).  The ALJ did not separately address whether the Facility’s failure to comply with any participation requirement had the potential to cause more than minimal harm, and instead addressed the question of substantial compliance only in the context of addressing the question of immediate jeopardy.
• back to note 6
7. CMS concedes that there “might be a worthy debate over the significance of the medication error [Tag F333],” but contends that summary judgment can nevertheless be sustained based on the two remaining deficiencies (Tags F157 and F281).  CMS Br. at 7, 9.  For the reasons explained below, we reject the contention that summary judgment can be affirmed on any basis.
• back to note 7
8. We do not find that oral argument is necessary or would facilitate our decision-making at this time and, therefore, in remanding the matter to the ALJ, we deny the Facility’s request for oral argument.
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9. For purposes of discussion, we use the term “harm” as shorthand for the regulatory terms “injury, harm, or impairment.”  See, e.g., Daughters of Miriam at 8.
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10. In its Pre-Hearing Brief and Motion for Summary Judgment, CMS argued that even a single missed dose of Prograf could cause rejection of a kidney and that Prograf “can only prevent rejection of the transplant if the medication is taken exactly as directed.”  SJ Br. at 13-15.  CMS did not specifically argue that the Facility’s deficiencies relating to the two missed doses of Prograf were “likely” to cause serious harm to Resident #14, but instead argued that “the immediate jeopardy situation” (a disputed fact) “had the potential to affect all residents on Resident #14’s unit receiving significant medication.”  SJ Br. at 14-15.  This argument is problematic because:  (i) it presumes an immediate jeopardy situation as to Resident #14; and (ii) a deficiency having the “potential to affect all residents” does not, by itself, establish “immediate jeopardy.”
• back to note 10
11. CMS further argues that the ALJ “found” that Facility staff failed to document in Resident #14’s medication administration record (MAR) that Prograf was unavailable.  CMS Br. at 1.  Although CMS had raised this argument in its summary judgment brief, the ALJ made no such finding about inadequate or improper documentation by Facility staff.
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12. Both of these exhibits are subject to evidentiary objections that the ALJ did not resolve.  See supra at 7.  As a result, and as further explained below, we are unable to determine what “undisputed material facts” the ALJ found “plainly support CMS’s determination of immediate jeopardy level noncompliance.”  ALJ Decision at 5.  We do not decide whether CMS Exs. 4 and 5 are admissible but note that neither exhibit conclusively establishes that missing two doses of Prograf is “likely” to cause serious harm or death.
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13. The Facility’s argument that there is no basis for an immediate jeopardy finding absent harm or a risk of serious harm to Resident #14 is inaccurate.  RR at 4.  The Board has acknowledged “that a reviewer should consider the nature of the noncompliance and decide whether it was likely to result in serious harm, not only to the resident or residents whose circumstances triggered the immediate jeopardy determination, but to the facility’s population at large.”  Daughters of Miriam at 12 (discussing Liberty Commons Nursing & Rehab. Ctr., DAB No. 2031, at 18-19 (2006), aff’d, 241 F. App’x 76 (4th Cir. 2007)).  This does not mean, however, that an immediate jeopardy determination may be upheld based on speculation.  See Spring Meadows at 36 (“In reviewing an immediate jeopardy determination, the reviewing body must consider the facts upon which CMS relied in making the determination, as well as any evidence presented at the hearing.”); see also Liberty Commons at 20-21 (upholding immediate jeopardy determination as not clearly erroneous where substantial evidence supported finding that a series of failures by the facility to implement precautions against latex exposure would likely result in serious harm to latex-allergic residents other than the resident that was the subject of the deficiency finding).  Moreover, an immediate jeopardy determination cannot be upheld on summary judgment if it requires drawing an unfavorable inference against the facility.  Cf. Innsbruck at 5 (“Summary judgment on the severity of noncompliance [immediate jeopardy] is appropriate only if no reasonable trier of fact, viewing the evidence in the light most favorable to [the facility] and drawing all reasonable favorable inferences from that evidence, could conclude that serious harm was less than likely.” (emphasis in original)).
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14. The Facility further argues that it should have been given the opportunity to cross-examine the state surveyors.  RR at 1, 7.  Because this matter must be remanded for a hearing, the Facility will have the opportunity for cross-examination.
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15. We review an ALJ’s summary judgment decision de novo.  See Avalon Place Kirbyville at 6.
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16. In its briefing, CMS repeatedly emphasizes that Prograf is a “significant medication.”  See, e.g., CMS Br. at 8.  It is unclear what CMS means by “significant medication” or what medications it would deem insignificant.  In any event, under section 483.45(f)(2), the issue is not whether Prograf is a “significant medication,” but whether the failure to administer two doses of Prograf is a significant medication error.  See Franklin Care Ctr., DAB No. 1900, at 8 (2003) (“[A] facility’s compliance with section 483.25(m)(2) [now 483.45(f)(2)] turns solely on whether it made a medication error or errors that were ‘significant.’”).  Not every medication error is significant; finding a deficiency under section 483.45(f)(2) involves the consideration of several factors, including the type of drug, the clinical condition of the resident, and the frequency of the error.  See Life Care Ctr. of Elizabethton, DAB No. 2367, at 6 (2011) (explaining that in assessing whether a medication error is “significant,” the Board has relied on statements in the preamble to the rule-making adopting the language of section 483.45(f)(2)).  These factual issues, among others, should be addressed on remand.
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17. The per-day CMP for noncompliance at the immediate jeopardy level, adjusted per 45 C.F.R. part 102, had an “upper range” of $6,394 to $20,965 per day at the time of the survey.  See 42 C.F.R. § 488.438(a)(1)(i); 45 C.F.R. § 102.3 (table - 2017).
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