Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
|IN THE CASE OF|
||DATE: September 29, 2003|
- v -
for Medicare & Medicaid Services
| Docket No. A-03-72
Civil Remedies No. CR1022
Decision No. 1896
FINAL DECISION ON REVIEW OF
Ross Healthcare Center (Ross) appealed the April 2, 2003 decision of Administrative Law Judge Steven T. Kessel (ALJ) sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose the remedy of denial of payments for new Medicare admissions (DPNA) against Ross for the period April 16, 2001 to May 22, 2001. (1) Ross Healthcare Center, DAB CR1022 (ALJ Decision). CMS had imposed the DPNA based on two surveys of Ross conducted by the New York State Department of Health (State survey agency) which found that Ross was not complying substantially with five Medicare participation requirements. At issue here is the State survey agency's finding that Ross failed to insure that its cardiopulmonary resuscitation (CPR) policy was implemented. As discussed in detail below, we sustain the ALJ Decision to uphold the DPNA.
The regulatory requirements for long-term care facilities are set forth at 42 C.F.R. Part 483. Section 483.13 contains requirements relating to "Resident behavior and facility practices." The requirement at issue here is the general requirement of subsection (c), captioned "Staff treatment of residents," and provides:
The term "neglect" is defined in section 488.301 of 42 C.F.R. to mean "failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."
Compliance with the participation requirements is determined through the survey and certification process, set out at 42 C.F.R. Part 488, Subpart E. Surveys are generally conducted by a state survey agency under an agreement with CMS. Based on a survey's findings, surveyors prepare a Statement of Deficiencies, which identifies and describes each failure to meet a participation requirement. See CMS's State Operations Manual (SOM) § 7316.
Sections 1819(h) and 1919(h) of the Act and Subpart F of Part 488 specify the remedies that may be imposed by CMS based on a determination that a facility is not in substantial compliance with the participation requirements. 42 C.F.R. § 488.400. "Substantial compliance" is defined as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." One of the available remedies is a DPNA. 42 C.F.R. §§ 488.406, 488.408, 488.417. CMS may impose a DPNA when there are "[w]idespread deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy" or "[o]ne or more deficiencies that constitute actual harm that is not immediate jeopardy." 42 C.F.R. § 488.408(d)(2)(i) and (ii). A DPNA continues until either "(1) The facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit" or "(2) CMS or the State terminates the provider agreement." 42 C.F.R. §§ 488.454(a), 488.417(d). A facility may appeal a certification of noncompliance leading to an enforcement remedy but may not appeal the choice of remedy. 42 C.F.R. § 488.408(g)(1) and (2).
Standard of Review
The standard of review on a disputed issue of law is whether the ALJ decision is erroneous. The standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence in the record as a whole. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (at http://www.hhs.gov/dab/guidelines/); see, e.g., Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home v. Dep't of Health & Human Srvcs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003). The applicable burden of proof requires CMS to come forward with sufficient evidence on disputed facts that together with the undisputed facts will establish a prima facie case that the facility is not complying with one or more participation requirements. The facility may rebut a prima facie case of noncompliance by showing, by a preponderance of the evidence, that it is in substantial compliance with participation requirements. Hillman Rehabilitation Center, DAB Nos. 1611 (1997), and 1663 (1998); aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J. May 13, 1999); see also Cross Creek Health Care Center, DAB No. 1665 (1998) (same framework applies in long-term care facility cases involving CMPs). Once CMS has established a prima facie case, the provider may then offer evidence in rebuttal, both by attacking the factual underpinnings on which CMS relied and by offering evidence in support of its own affirmative arguments. An effective rebuttal of CMS's prima facie case would mean that at the close of the evidence the provider had shown that the facts on which its case depended (that is, for which it had the burden of proof) were supported by a preponderance of the evidence. Id.
The ALJ Decision
The ALJ made three findings of fact and conclusions of law:
1. Petitioner did not prove by the preponderance of the evidence that it complied with the participation requirement that is stated at 42 C.F.R. § 483.13(c)(1)(i).
2. Petitioner did not prove that it attained compliance with the requirements of 42 C.F.R. § 483.13(c)(1)(i) prior to May 22, 2001.
3. CMS was authorized to impose against Petitioner the remedy of denial of payments for new Medicare admissions for each day of the April 16 - May 22, 2001 period.
ALJ Decision at 3, 8.
In his decision, the ALJ addressed only one of the five participation requirements cited by the State survey agency, 42 C.F.R. § 483.13(c). (3) With respect to that requirement, the ALJ found that CMS had provided prima facie evidence that Ross did not implement its CPR policy when Resident # 1 experienced cardiopulmonary arrest on March 10, 2001. ALJ Decision at 6. The ALJ described the policy as "a blanket declaration that Petitioner will provide CPR to any resident who suffers a cardiopulmonary arrest except in the circumstance where the resident, via a DNR [do not resuscitate] request, specifically asks that CPR not be provided." Id. at 5. (4) It was undisputed that Resident 1 did not have a DNR request. The ALJ also found that CMS "offered prima facie evidence to show that Petitioner's failure to provide CPR to Resident # 1 posed the potential for more than minimal harm to the resident." Id. at 6. The ALJ cited testimony by CMS's witness, Dr. Gutierrez, that CPR is a procedure that is used to attempt to preserve life when everything else has failed, so that failure to utilize CPR has the potential to harm a patient because it eliminates a possibility that a dying patient may be revived. The ALJ wrote:
ALJ Decision at 6-8.
1. The ALJ did not err in concluding that Ross was not in substantial compliance with section 483.13(c).
Ross argued that the ALJ erred in concluding that it was not in substantial compliance with section 483.13(c). (5) First, Ross took exception to the statement in the ALJ Decision that "Petitioner failed to provide a service (CPR) to a resident that was necessary if Petitioner sought to extend the resident's life" (ALJ Decision at 7). According to Ross, the preponderance of the evidence established that CPR would have been a futile procedure for Resident 1. Second, Ross took exception to the statement in the ALJ Decision that, since Resident 1 did not have a DNR request, "Ross was obligated to offer CPR to the resident in the event of the resident's respiratory failure or cardiac arrest" (id.). Ross argued that, under New York law, the absence of a DNR implies consent to perform CPR but does not create a duty or obligation to perform it in all instances. According to Ross, the duty to perform CPR under New York law is defined by standards of care and professional guidelines, which Ross maintained do not obligate a facility to perform CPR in all instances in which there is no DNR request. Third, Ross took exception to the ALJ's finding that the failure to provide CPR to Resident 1 posed the potential for more than minimal harm (id. at 6). Ross maintained that this finding was contradicted by the evidence that CPR would have been a futile procedure for Resident 1 as well as by the ALJ's statement elsewhere in the decision that "Petitioner made a convincing showing that Resident 1, by virtue of her medical condition and associated problems, would not have benefited from CPR" (id. at 8). Fourth, Ross took exception to the ALJ's finding that its failure to follow its policy on CPR in the case of Resident 1 constituted a failure to implement a policy to prevent neglect. Ross maintained that it did not neglect Resident 1 by not providing CPR since CPR would have been futile. Ross also maintained that "evidence of an isolated act of neglect is not prima facie proof of a failure to implement a policy to prevent neglect," citing Beverly Health & Rehabilitation Center - Springhill, DAB CR553 (1998), aff'd, DAB No. 1696 (1999), and Life Care Center of Hendersonville, DAB CR542 (1998). Ross further argued that its failure to follow its policy on CPR was not a deficiency since there was no evidence in the record to show that the policy represents the professional standard of care. As explained below, none of Ross's arguments provide a basis for reversing the ALJ Decision.
Ross's policy on CPR did not contain any express exception for residents who have been assessed, either at the time they were found to have suffered a cardiopulmonary arrest or at some earlier time, as someone who would not benefit from CPR. Thus, the ALJ might reasonably have concluded that any failure by Ross to follow its policy on CPR was a failure to implement a policy to prevent neglect because Ross did not provide care which Ross, by adopting its policy on CPR, determined to be necessary. The ALJ instead read Ross's policy on CPR to permit some exception of the type described above. He nevertheless concluded that Ross's failure to provide CPR to Resident 1 constituted neglect because Ross had not established that it made any determination that the general policy on CPR was not applicable to Resident 1. The ALJ further concluded that the neglect posed a potential for more than minimal harm both to Resident 1 and to any other residents in the facility without a DNR request who might benefit from this potentially lifesaving procedure. None of Ross's arguments persuade us that these conclusions are erroneous.
The ALJ's statement to the effect that CPR was necessary to extend Resident 1's life correctly refers to the situation as Ross knew it to be at the time it failed to provide CPR. The ALJ found, and Ross did not dispute, that Ross had not assessed Resident 1 prior to her cardiopulmonary arrest as someone who would not benefit from CPR. As CMS pointed out, moreover, there is no evidence in the record of any contemporaneous determination by a nurse or doctor that providing CPR to Resident 1 would be medically futile. CMS Br. at 23. Accordingly, Ross had no basis at the time for determining that CPR would not in fact have benefitted Resident 1. As Ross noted, the ALJ also found that Ross had established in the proceeding before him that, based on Resident 1's medical condition and associated problems, she would not have benefitted from CPR. The ALJ nevertheless concluded, and we agree, that it is immaterial whether it could be determined with hindsight that Resident 1 would have benefitted from CPR. Ross's failure to provide CPR constituted neglect within the meaning of the regulation at 42 C.F.R. § 488.301 since Ross had a policy to provide CPR to any patient without a DNR and, as far as Ross knew, Resident 1 might have been resuscitated by CPR, thus making CPR "necessary to avoid physical harm." (6) That Ross established before the ALJ based on outside expert testimony that providing CPR to Resident 1 would have been futile does not transform Ross's withholding of CPR into appropriate care.
We also agree with the ALJ that Ross's neglect of Resident 1 posed the potential for more than minimal harm. As the ALJ found, there was a potential for such harm to Resident 1 because a potentially lifesaving procedure was denied her without any determination being made that she would not benefit from it. More significantly, since Ross did not show that it had a valid basis at the time for not following its policy on CPR with respect to Resident 1, the ALJ could reasonably conclude that Ross's failure to implement its policy on CPR posed a potential for more than minimal harm to all of the residents in the facility who had no DNR request since there was no assurance that any residents among them who might benefit from CPR would receive it in the event of a cardiopulmonary arrest. (7) Contrary to what Ross argued, moreover, no pattern of neglect was necessary to show that Ross failed to implement a policy to prevent neglect. Ross did not claim that its nurse acted improperly in not providing CPR to Resident 1 or that other facility staff would have provided CPR in a similar situation. Thus, it was clear that Ross failed to implement its own written policy identifying the provision of CPR to any resident without a DNR request as necessary care. The ALJ decisions cited by Ross are not on point since they do not address the situation here where the facility has in effect already identified the act in question as constituting neglect.
Furthermore, under the ALJ's rationale it is clear that a potential for more than minimal harm exists even if Ross's policy to provide CPR to all residents without a DNR request did not represent the standard of care. The ALJ acknowledged that Ross could have met its residents' needs "more selectively" by adopting "a mechanism to assess those residents who experienced cardiac or respiratory arrest and to provide CPR only to those residents who would benefit." ALJ Decision at 8. However, the ALJ reasonably concluded that since Ross had adopted a blanket policy to provide CPR to all residents without a DNR request, it could assure that CPR was provided to all such residents who might benefit from it only by following its policy.
In addition, contrary to what Ross's argument suggests, the ALJ did not find that New York law required a nursing facility to provide CPR in the absence of a DNR request. The ALJ did not reach the issue of what New York law required, stating that "whether Petitioner's policy reflects a State mandate is, in the final analysis irrelevant to establishing how Petitioner has chosen to deal with a resident who suffers from a cardiopulmonary arrest." ALJ Decision at 6; see also id. at 8.
Accordingly, the ALJ correctly concluded that Ross's failure to implement its policy to provide CPR to all residents without a DNR request constituted a lack of substantial compliance with section 483.13(c).
2. The issue of when Ross achieved compliance is not properly before the Board.
In support of his conclusion that Ross did not prove that it attained compliance with the requirements of section 483.13(c) prior to May 22, 2001, the ALJ stated:
ALJ Decision at 8.
On appeal, Ross argued that it attained substantial compliance before the DPNA was imposed on April 16, 2001. According to Ross, all of its evidence and arguments in this case "have been aimed at proving that it was in compliance prior to May 22, 2001." Ross Reply Br. at 4. Ross stated that the ALJ "apparently failed to review" exhibits which Ross contended "demonstrate that by April 13, 2001, petitioner had completed all steps in its Plan of Correction and was in substantial compliance by that date." Id. at 5.
We conclude that the ALJ properly determined that Ross failed to challenge CMS's determination that Ross came into compliance on May 22, 2001. Ross did not identify any point in the proceedings before the ALJ at which Ross argued that it achieved compliance prior to May 22, 2001. Our review of the Ross's briefs below shows that Ross instead argued only that it was not out of compliance in the first instance.
Moreover, since Ross did not raise the issue of when it came into compliance before the ALJ, it is not properly considered on appeal. The Board's Guidelines provide that "the Board will not consider issues not raised in the request for review, nor issues which could have been presented to the ALJ but were not." In part, this guideline reflects the fact that our review of an ALJ decision is limited primarily to whether the ALJ decision was erroneous as a matter of law or unsupported by substantial evidence on the record as a whole. Since Ross did not raise this issue before the ALJ, there is nothing in the ALJ Decision to review pursuant to these standards. This guideline also promotes judicial economy and efficiency, since it makes it less likely that a case will be heard piecemeal. Since Ross did not argue that it could not have presented this issue to the ALJ, we see no reason why it should be given an opportunity to raise the issue now.
In any event, evidence regarding Ross's completion of the steps in its plan of correction would not be sufficient to establish that it achieved substantial compliance prior to May 22, 2001. A facility must submit a plan of correction for approval by the State survey agency if a survey reveals that a facility is not in substantial compliance with participation requirements. 42 C.F.R. §§ 488.402(d). The regulations further provide that substantial compliance must be established by a resurvey or after an examination of credible written evidence produced by the facility (verifiable without an on-site visit). 42 C.F.R. § 488.454(a)(1). The preamble to the regulations adopting the present enforcement scheme states, however, that adherence to a plan of correction is not conclusive evidence of substantial compliance. See Warren N. Barr Pavilion of Illinois Masonic Medical Center, DAB No. 1705, at 7 (1999), citing 59 Fed. Reg. 56,203 (Nov. 10, 1994).
3. It is not necessary to consider Ross's arguments regarding its compliance with participation requirements other than 42 C.F.R. § 483.13(c).
CMS's determination to impose the DPNA was based on the findings of the State survey agency, which concluded that Ross was out compliance with five participation requirements. The ALJ Decision addressed only the participation requirement at 42 C.F.R. § 483.13(c), although the record below contains testimonial and documentary evidence pertaining to all five participation requirements and the parties addressed all five requirements in their post-hearing briefs. The ALJ stated in pertinent part:
ALJ Decision at 2-3.
On appeal, Ross addressed all five of the participation requirements with respect to which the State survey agency found a deficiency, arguing that it was in compliance with each such requirement. Ross argued that all of the alleged deficiencies were properly before the Board since the Board has the authority to remand the case to the ALJ or modify, affirm, or reverse the ALJ's decision "based upon the evidence in the hearing record." Ross Reply Br. at 5, quoting 42 C.F.R. § 498.88(f). CMS responded that since section 498.82(b) of the regulations governing appeals provides that a request for review of an ALJ decision "must specify the issues, the findings of fact or conclusions of law with which the party disagrees," only the ALJ's findings with respect to section 483.13(c) are properly before the Board for review. CMS requested "that the Board uphold these findings and affirm the ALJ's decision sustaining the remedy imposed by CMS." CMS Br. dated 7/10/03, at 3.
CMS's reading of section 498.82(b) is unduly narrow. Whether the ALJ properly sustained the remedy imposed by CMS without addressing matters as to which there was a proper hearing request is clearly an "issue" as to which a facility may request review. Moreover, as Ross pointed out, under section 498.88(f), the Board is authorized to make a determination regarding whether Ross was in compliance with the participation requirements other than section 483.13(c) even if the ALJ did not. Alternatively, section 498.88(f) authorizes the Board to remand the case to the ALJ to consider the evidence in the record on the issue of Ross's compliance with these participation requirements. However, we decline to exercise either authority here.
Under section 488.408(d)(2)(i), CMS has authority to impose a DPNA when there are "[w]idespread deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy." Here, CMS imposed a DPNA based on the finding at the March 28, 2001 revisit survey that a deficiency under section 483.13(c) continued at this level of scope and severity. We concluded above that the ALJ properly found that Ross was not in substantial compliance with section 483.13(c) based on this revisit survey finding. Thus, the ALJ is correct that CMS was authorized to impose the DPNA regardless of whether Ross was in compliance with the other participation requirements as to which there were deficiency findings. Also, CMS asked us to affirm the ALJ Decision affirming the remedy based on the one deficiency, and we may not review the choice of remedy by CMS. The ALJ's failure to address the remaining deficiency findings is therefore not a basis on which we would reverse or remand the ALJ Decision. (8)
For the reasons above, we uphold the ALJ's decision sustaining the imposition of the DPNA. We adopt and affirm finding of fact and conclusion of law 3. We also modify findings of fact and conclusions of law 1 and 2 to read as follows:
Judith A. Ballard
Cecilia Sparks Ford
1. CMS was previously named the Health Care Financing Administration (HCFA). See 66 Fed. Reg. 35,437 (July 5, 2001).
2. Although the ALJ quoted only this introductory paragraph, his decision cites section 483.13(c)(1)(i) (consistent with the Statement of Deficiencies, which cited section 483.13(c)(1)(i)). Subsection (1)(i) provides:
Since the allegation of noncompliance involves only the language in the introductory paragraph, we modify findings of fact and conclusions of law 1 and 2 to refer to section 483.13(c) instead of section 483.13(c)(1)(i).
3. The Statement of Deficiencies for the March 16, 2001 survey cites a deficiency under this section that was widespread and posed immediate jeopardy to resident health or safety (level "L"). P. Ex. 12; CMS Ex. 2. The statement of deficiencies for the March 28, 2001 revisit survey is not in the record; however, the record indicates that the State survey agency and CMS found that this deficiency continued, although the immediate jeopardy had abated and the deficiency now posed no actual harm with a potential for minimal harm that is not immediate jeopardy (level "F"). See, e.g., letter from CMS to Ross dated 3/30/01, at 1; CMS Ex. 65, at 2; Respondent's Post-Hearing Brief dated 1/31/03, at 1, n.1.
One of the four other deficiency findings (under section 488.25(k)) involved Ross's alleged failure to report Resident 1's frequent requests for tracheal suctioning to her physician. Two of the other deficiency findings (under sections 488.25 and 488.75(i)) were related to Ross's failure to provide CPR to Resident 1. Another deficiency finding (under section 488.75) was based on all of the other deficiency findings. P. Ex. 12; CMS Ex. 2.
4. The ALJ first quoted a policy dated March 12, 2001 which stated:
The ALJ stated that neither party suggested that a different policy was in effect prior to the incident on March 10, 2001 involving Resident 1. The ALJ also said that earlier versions of the policy stating that "CPR will be attempted for any resident found to have no palpable pulse and/or no discernable respiration unless there is a current physician order for DNR" were essentially the same as the March 12, 2001 policy. ALJ Decision at 5.
5. Findings of fact and conclusions of law 1 and 2 refer to Ross's lack of compliance rather than its lack of substantial compliance. Under the regulations identified earlier, imposition of a remedy is justified only where substantial compliance is lacking. It is clear in context that the ALJ intended to refer to substantial compliance. We therefore modify findings of fact and conclusions of law 1 and 2 to use the correct terminology.
We also note that the ALJ Decision refers to a "'substantial' deficiency," (stating, for example, that "I would find that the presence of even one substantial deficiency . . . would be sufficient to justify the imposition of remedies against Petitioner"). ALJ Decision at 3. However, "substantial deficiency" is not a term used in the regulations. A failure to comply with a participation requirement is a deficiency. If a deficiency poses the potential for more than minimal harm to resident health or safety, then the facility has failed to substantially comply with the participation requirement.
6. We see nothing in the definition of "neglect" that supports Ross's argument that CMS must establish "to a reasonable degree of medical certainty" that CPR was a service necessary to avoid physical harm to Resident 1. See Ross Reply Br. at 1-3.
7. Under section 498.60(c)(2), CMS's determination as to the level of noncompliance must be upheld unless it is clearly erroneous. Ross did not show any clear error here.
8. We note that there are some circumstances in which the ALJ's failure to address all of the deficiency findings could affect the remedy, such as where CMS relied on the additional deficiency findings in determining that the facility had not achieved substantial compliance before a certain date or in setting the amount of a civil money penalty above the minimum amount (i.e., above $50 for a non-immediate jeopardy deficiency or above $3,050 for an immediate jeopardy deficiency). Under such circumstances, the ALJ's failure to address all of the deficiency findings could be prejudicial to the facility. Here, however, the DPNA ended on the date when CMS found Ross came into substantial compliance with section 483.13(c) and CMS had no control over the amount of income lost as a result of the DPNA.