SUBJECT: Innsbruck HealthCare Center,

Petitioner,

Centers for Medicare & Medicaid Services

REMAND OF
ADMINISTRATIVE LAW JUDGE DECISION

On April 19, 2004, the Innsbruck HealthCare Center (Innsbruck) appealed the February 9, 2004, decision of Administrative Law Judge (ALJ) Steven T. Kessel granting summary disposition in favor of the Centers for Medicare & Medicaid Services (CMS). Innsbruck HealthCare Center, DAB CR1141 (2004) (ALJ Decision). The ALJ Decision sustained CMS's determination that Innsbruck must not conduct a nurse aide training program (NATCEP) for a period of two years beginning April 10, 2003, as a legal consequence of a finding of substandard quality of care. The ALJ based this finding on his conclusion that Innsbruck was out of compliance with the requirements of 42 C.F.R. § 483.25(i)(2) to a degree that posed immediate jeopardy to the residents. For the reasons explained fully below, we conclude that summary judgment was appropriate as to Innsbruck's failure to comply substantially with the cited regulations. We conclude, however, that genuine issues of material fact remain as to whether the noncompliance was at the immediate jeopardy level, and hence whether the loss of NATCEP authority applied as a matter of law. Therefore, we remand the matter to the ALJ for the presentation of evidence as to the level of noncompliance.

Background

Innsbruck is a skilled nursing facility (SNF) in New Brighton, Minnesota. A survey conducted by the Minnesota Department of Health on April 10, 2003, concluded that Innsbruck manifested a deficiency at the immediate jeopardy level. The surveyors found that Innsbruck failed to comply substantially with the requirements of 42 C.F.R. § 483.25(i)(2) because it did not provide therapeutic diets to several of its residents who were assessed with nutritional deficits. CMS agreed, and, as a consequence, determined that Innsbruck would lose its authority to conduct a NATCEP for a period of two years beginning April 10, 2003.

Innsbruck timely sought a hearing before the ALJ. CMS moved for summary disposition, which Innsbruck opposed. Both parties submitted exhibits, which the ALJ accepted into the record. The ALJ granted CMS's motion and made the following three Findings of Fact and Conclusions of Law (FFCLs):

1. Summary disposition is appropriate.

2. Petitioner had an immediate jeopardy level deficiency as of April 10, 2003.

3. Petitioner loses its authority to conduct NATCEP for a two-year period, beginning April 10, 2003, as a consequence of having an immediate jeopardy level deficiency on that date.

ALJ Decision at 2, 3, 8. In supporting FFCL 2, the ALJ set out four factual assertions by CMS which the ALJ found that Innsbruck had not disputed:

• Resident Nos. 5 and 26 were diagnosed to be suffering from swallowing difficulties. CMS Ex. 5, at 65 - 67; CMS Ex. 9, at 19, 27.

• Each of these residents had a history of aspirating fluids and was at risk for developing pneumonia related to aspiration. CMS Ex. 5, at 58, 61 - 62; CMS Ex. 9, at 24 - 27.

• Resident No. 5 and Resident No. 26 each was prescribed a diet which included thickened liquids and which excluded liquids that were not thickened. CMS Ex. 5, at 33, 64; CMS Ex. 9, at 1; 20 - 21.

• During the April 2003 survey, each resident was observed to have been served an unthickened liquid consisting of soup that was not thickened. CMS Ex. 13, at 1, 2; CMS Ex. 23, at 2 - 3.

ALJ Decision at 3-4.

Applicable Law

SNFs participating in the Medicare program are subject to survey and enforcement procedures set out in 42 C.F.R. Part 488, Subpart E, to determine if they are in substantial compliance with applicable program requirements which appear at 42 C.F.R. Part 483, Subpart B. "Substantial compliance" means a level of compliance such that "any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301. "Noncompliance," in turn, is defined as "any deficiency that causes a facility to not be in substantial compliance." 42 C.F.R. § 488.301.

The requirement with which Innsbruck was found not to be in substantial compliance is one of the components of the quality of care regulation. This regulation requires generally that the facility must ensure that each resident receive and the facility provide "the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care." 42 C.F.R. § 483.25. The specific provision at issue reads as follows:

(i) Nutrition. Based on the resident's comprehensive assessment, the facility must ensure that a resident --

* * *

(2) Receives a therapeutic diet when there is a nutritional problem.

42 C.F.R. § 483.25(i)(2) (also referred to as Tag F326).

Section 1819(f)(2)(B)(iii)(I) of the Social Security Act precludes approval of a NATCEP for two years in facilities that have been subject to a finding of substandard care in a standard survey. See also 42 C.F.R. §§ 483.151(b)(2); 488.310. CMS regulations define "substandard care" to include deficiencies in meeting quality of care requirements at 42 C.F.R. § 483.25 found to be at the level of "immediate jeopardy." "Immediate jeopardy" is defined as "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. § 301.

The regulations governing appeals permit a challenge by the facility to CMS's determination of the level of noncompliance where it would affect "a finding of substandard quality of care that results in the loss of approval for . . . a nurse aide training program." 42 C.F.R. § 498.3(b)(14)(ii).

A. We review the appropriateness of summary judgment de novo in accordance with standards reiterated in many Board decisions.

Whether summary judgment is appropriate is an issue that we address de novo. Lebanon Nursing and Rehabilitation Center, DAB No. 1918 (2004). Summary judgment may be entered when the record shows that there is no genuine dispute as to any material fact, and the moving party is entitled to judgment as a matter of law. Lebanon. The party moving for summary judgment bears the initial burden of showing the basis for its motion and identifying the portions of the record that it believes demonstrate the absence of a genuine factual dispute. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). This burden may be discharged by showing that there is no or insufficient evidence proffered to support a judgment for the non-moving party. Id. at 325. If a moving party carries its initial burden, the non-moving party must "come forward with 'specific facts showing that there is a genuine issue for trial.'" Matsushita Elec. Industrial Co. v. Zenith Radio, 475 U.S. 574, 587 (1986) (quoting Fed. R. Civ. P. 56(e)). To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a genuine dispute concerning a material fact ---- a fact that, if proven, would affect the outcome of the case under governing law. Id. at 586, n.11; Celotex, 477 U.S. at 322. In deciding a summary judgment motion, a tribunal may not make credibility determinations or weigh conflicting evidence but must instead view the entire record in the light most favorable to the non-moving party, drawing all reasonable inferences from the evidence in that party's favor. Madison Health Care, Inc., DAB No. 1927 (2004).

B. Innsbruck conceded the existence of the cited deficiency but raised genuine disputes of material fact as to CMS's determination of the level of noncompliance.

On appeal, Innsbruck conceded the existence of facts sufficient to establish noncompliance with Tag F326. Innsbruck Br. at 3, n.1. Specifically, Innsbruck did not dispute that two residents were prescribed thickened liquids due to swallowing difficulties, that each resident was at risk for pneumonia with unthickened liquids, and that each was observed to be consuming unthickened soup during the survey.

Based on these concessions, we affirm the ALJ's conclusion that Innsbruck was not in substantial compliance with the cited requirement. This conclusion, however, does not resolve the level of noncompliance.

CMS asserted that the deficiency constituted immediate jeopardy. The ALJ concluded that "the undisputed material facts of this case are sufficient for me to find that Petitioner's failure to follow its nutritional plans for Resident Nos. 5 and 26 put the residents at risk for serious harm" and that "in turn, is sufficient for me to conclude that Petitioner manifested an immediate jeopardy level of deficiency." ALJ Decision at 7 (emphasis added).

The ALJ's conclusion cannot be affirmed for two reasons. First, a determination of immediate jeopardy requires a showing that serious harm is likely, not merely that a risk of serious harm exists. Second, Innsbruck proffered evidence on several facts which are material to CMS's basis for finding immediate jeopardy.

On the first point, we note that, where there is no actual harm, the regulations specify that immediate jeopardy exists only if the noncompliance is "likely" to cause serious harm. 42 C.F.R. § 488.301. A mere risk of serious harm is not equivalent to a likelihood of serious harm. ⁽¹⁾ Nor is the failure to follow an item in a plan of care sufficient in itself to establish a likelihood of serious harm, and the degree of likely harm is itself a question of fact. Hence, the ALJ's finding that the residents were at risk of serious harm is not sufficient, as a matter of law, to support his conclusion that "immediate jeopardy" existed as that term is defined in the regulations.

Summary judgment on the severity of noncompliance is appropriate only if no reasonable trier of fact, viewing the evidence in the light most favorable to Innsbruck and drawing all reasonable favorable inferences from that evidence, could conclude that serious harm was less than likely.

Turning to the second point, Innsbruck contended that the surveyors' opinions about harm relied in part on allegations that one of the residents had a history of aspiration pneumonia (and thus had an elevated risk of recurrence) and that a widespread problem existed with providing diets of prescribed consistency to residents. Innsbruck proffered evidence disputing both factual allegations. Innsbruck also argued that, contrary to the allegations in the statement of deficiencies, the residents were adequately supervised during the meal in a manner which minimized the potential harm to them of consuming unthickened soup. Further, Innsbruck argued that one of the residents who chose the unthickened soup and rejected the alternative thickened soup was exercising her right to refuse treatment. We discuss each of these factual issues in turn and find that, contrary to the ALJ's conclusions, these disputes of fact are material to review of CMS's findings as to the level of noncompliance.

First, we agree with CMS that evaluating the severity of a deficiency cannot be reduced to "mathematical judgments for which there are clear or objectively measured boundaries" and therefore the regulations generally provide that the surveyors are granted "flexibility and deference, in applying their expertise in working with these less than perfectly precise concepts." CMS Response Br., quoting 59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994). For that very reason, it is material to evaluating the immediate jeopardy determination to consider the factual underpinnings on which the surveyors relied to apply their expertise. The surveyor who wrote the immediate jeopardy finding regarding Residents 5 and 26 stated that her judgment was based on the residents' history of silent aspiration and of pneumonia, including aspiration pneumonia. CMS Ex. 23, at 2-3. She further noted that the likelihood of serious harm reflected her conclusion that Innsbruck was not following a system to ensure food orders were followed, thus potentially affecting residents other than those specifically cited. Id. at 3.

The ALJ rejected as immaterial Innsbruck's dispute with the factual accuracy of the surveyor's statements that the resident had had aspiration pneumonia and that a systemic problem existed. We disagree. Since the surveyor cited both of these factors as relevant to her professional judgment, the facts underlying those assessments are necessarily material to whether immediate jeopardy existed. On a motion for summary judgment, the ALJ may not rely on the testimonial opinion evidence of the surveyor as a basis to support an immediate jeopardy conclusion and yet ignore proffered evidence disputing the facts on which that opinion is based. We conclude that Innsbruck was entitled to present its proffered evidence on the resident's medical history and on the absence of a systemic problem.

The ALJ also discounted as irrelevant Innsbruck's proffered evidence regarding the level of supervision the residents had while eating the "thin" soup at issue. Viewed in the light most favorable to Innsbruck, however, the evidence on supervision (which contradicted some of the surveyor's observations) might tend to show that Innsbruck had minimized the risks of aspiration that otherwise would be caused by the thin soup by providing oversight, therefore making serious harm less likely. See, e.g., P. Exs. 1, 5. Moreover, the surveyor's declaration bases her opinion, with respect to each resident, that there was a likelihood of serious harm to the resident on both the failure to serve liquids of the proper thickness and the alleged failure to assist/monitor the resident. CMS Ex. 23, at 2-3.

Innsbruck also offered, as relevant in examining the level of noncompliance, testimony that one of the residents had exercised freedom of choice consistent with her care plan by electing to have the thin chicken soup rather than thickened broccoli soup. P. Ex. 6, at 5-6. The ALJ concluded that this contention was not supported by any facts proffered by Innsbruck, because the facility nurse's statement did not point to anything in the resident's care plan or facility policies supporting her interpretation. ALJ Decision at 6. The ALJ also ruled that the nurse's conclusion that the resident had a "right to substitute food choices" was legally incorrect, because such rights do not extend to food choices specifically precluded by the care plan. Id.

Under the regulations cited by Innsbruck, a resident has the right to refuse treatment and to make choices about significant aspects of life in the facility. 42 C.F.R. §§ 483.10(b)(4), 483.15(b)(3). The facility must document any treatment refusal, and the resident's right to choose health care is qualified by the phrase "consistent with his or her interests, assessments, and plans of care." Id. Viewed in the light most favorable to it, Innsbruck's proposed testimony could indicate that Innsbruck reasonably thought it was required under the regulations to respect the resident's choice, hence suggesting that the deficiency was merely one of failing to document resident choice. Even if Innsbruck was mistaken in this interpretation of the regulatory requirements, the evidence could also be material to whether nonadherence to plans of care as to food consistency was a systemic problem.

CMS also offered evidence with respect to other residents as part of its evidence of systemic problems leading to the immediate jeopardy determination. CMS conceded that these other examples did not by themselves involve immediate jeopardy. CMS Br. at 11-12. CMS did not argue that the facts it presented relating to Residents 5 and 26 alone demonstrated a widespread systemic problem. CMS instead asserted, based on the surveyors' declarations, that this "more general failure, considered in conjunction with Innsbruck's failure to adhere to the dietary restrictions for Residents 5 and 26, led the surveyors to conclude that the deficiencies posed a likelihood of causing serious harm." Id. at 12, citing CMS Ex. 24, at 2, and CMS Ex. 23, at 4. In light of these statements, the facts regarding the allegations relating to other residents may be material to the existence of immediate jeopardy.

Finally, since the evaluation of immediate jeopardy is, as stated above, a matter of judgment based on factual issues, expert testimony as to the assessment of the level of noncompliance may be material. Innsbruck sought to present its own qualified opinion testimony on the issue of whether serious harm was likely. A rational trier of fact might credit the opinions of Innsbruck's experts, after evaluating their relative qualifications and degree of personal knowledge of the residents. The offer of such expert testimony by Innsbruck shows that there was a genuine dispute of fact over the assessment of the degree of risk to the residents. See, e.g., P. Exs. 5, at 2-7, and 6, passim. Since CMS relied on surveyors' opinions on this issue, Innsbruck also should have had an opportunity to cross-examine the surveyors on the bases for their opinions and on whether their opinions might change if the evidence showed the facts to be different than the surveyors assumed.

We conclude that there exist genuine issues of material fact relating to CMS's determination that the level of noncompliance constituted immediate jeopardy. Hence, a remand is required to resolve the outstanding issues.

D. We need not resolve the standard of review of the immediate jeopardy determination at this stage of the proceedings.

The parties disputed before the ALJ, and on appeal, what standard of review should apply to review of CMS's determination of immediate jeopardy under the regulations in a matter not involving a civil monetary penalty. Under section 498.60(c)(2), an immediate jeopardy determination in a civil monetary penalty case may be overturned only if found to be "clearly erroneous." CMS argued that the same standard should apply here, relying on the Board's decision in Woodstock Care Center, DAB No. 1726 (2000), aff'd sub nom. Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003), which applied this deferential standard. CMS Br. at 13. Woodstock, however, involved a CMP. CMS acknowledged, moreover, that "the literal wording of section 498.60(c)(2) does not require the use of the clearly erroneous standard in this case." Id.

The ALJ determined that he did not need to reach the issue of the applicable standard at this stage of the case. He concluded that he "would rule in Petitioner's favor if it showed any material facts to be in dispute regardless of whether I would ultimately decide that those facts are sufficient to overcome the facts offered by CMS." ALJ Decision at 7-8, n.3. Having found that material facts are in dispute as to CMS's determination of the level of noncompliance, we agree with the ALJ that this showing suffices to require further proceedings regardless of the standard ultimately applicable to weigh the conflicting presentations of the parties on the immediate jeopardy issue.

Given the novelty and complexity of this issue, and the fact that this matter must in any event be remanded to the ALJ, we decline to resolve it at this stage of the proceedings. The issue is better left to the ALJ to consider in the first instance in the context of a fully developed record and complete briefing.

Conclusion

For the reasons explained in detail above, we remand this matter to the ALJ for further proceedings consistent with this decision.

Specifically, we vacate FFCL 3 and modify FFCLs 1 and 2 to read as follows:

1. Summary disposition is appropriate as to the question of Petitioner's noncompliance with Tag F326.

2. Petitioner had a deficiency under Tag F326 as of April 10, 2003.

Daniel Aibel

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

1. While the ALJ Decision elsewhere quotes the correct definition of "immediate jeopardy," we cannot in this case infer that the ALJ in fact applied the correct standard in spite of his use of the word "risk" rather than "likelihood" in stating his conclusion. His decision as a whole indicates that he wholly discounted evidence proffered by Innsbruck going to the likelihood of serious harm from its admitted noncompliance. Thus, the ALJ's error was not harmless error.