SUBJECT:

ACT of Health

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I decide that Petitioner, ACT for Health, proved that it removed an immediate jeopardy level deficiency in its operations by February 28, 2004. Consequently, the Centers for Medicare & Medicaid Services (CMS) was not authorized to terminate Petitioner's Medicare participation on that date.

I. Background

Petitioner is a home health agency which operates in the State of Colorado. Prior to February 28, 2004, it participated in the Medicare program. Its participation was governed by sections 1861(o), 1866(b)(2), and 1891 of the Social Security Act (Act), and by federal regulations at 42 C.F.R. Parts 484 and 489.

On February 5, 2004 (February survey), Petitioner was surveyed by the Colorado Department of Public Health and Environment (Colorado survey agency) in order to determine whether Petitioner was complying with participation requirements. The surveyors concluded that Petitioner was not complying with numerous requirements, including several conditions of participation for home health agencies. In one instance Petitioner's noncompliance was determined to be so egregious as to constitute immediate jeopardy to beneficiaries under Petitioner's care. CMS concurred with these findings and determined that, unless the immediate jeopardy level deficiency was corrected, it would terminate Petitioner's participation in Medicare pursuant to section 1891(e)(1) of the Act.

Petitioner was afforded the opportunity to submit a plan of correction to show how it intended to attain compliance with participation requirements. Petitioner submitted a total of six plans of correction. Each was rejected. On February 28, 2004, CMS terminated Petitioner's participation in Medicare.

Petitioner requested an expedited hearing in order to contest CMS's determination to terminate its participation. On April 14, 2004 I held an expedited hearing in Denver, Colorado. At the hearing I received into evidence exhibits from CMS consisting of CMS Ex. 1 - CMS Ex. 33. I received into evidence exhibits from Petitioner consisting of P. Ex. 1 - P. Ex. 20. The parties' exhibits included the written direct testimony of witnesses. I afforded the parties the opportunity to cross-examine these witnesses. Petitioner cross-examined one witness, Linda Pero, R.N. Tr. at 37 - 63; CMS Ex. 2. CMS did not cross-examine any witnesses.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are whether:

1. CMS established a prima facie case, which Petitioner did not disprove by the preponderance of the evidence, that, as of February 5, 2004, Petitioner manifested an immediate jeopardy level failure to comply with a condition of participation in Medicare.

2. Petitioner proved that it removed immediate jeopardy by February 28, 2004.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case and set forth each Finding below as a separate heading. I discuss my Findings in detail.

1. CMS established a prima facie case, which Petitioner did not disprove by the preponderance of the evidence, that, as of February 5, 2004, Petitioner manifested an immediate jeopardy level failure to comply with a condition of participation in Medicare.

Section 1891(e)(1) of the Act authorizes the Secretary of Health and Human Services (Secretary) to terminate the participation in Medicare of a home health agency whose failure to comply with participation requirements immediately jeopardizes the health and safety of the individuals to whom the agency furnishes items and services. ⁽¹⁾ In this case the Colorado survey agency and CMS found that Petitioner failed to comply with the requirements of a condition of participation and that its failure to do so immediately jeopardized the health and safety of the individuals whom Petitioner served. That, coupled with CMS's determination that Petitioner failed to submit an acceptable plan of correction and achieve compliance by February 28, 2004, is the basis for the termination of Petitioner's participation in Medicare.

The term "immediately jeopardizes" is not defined in the Act nor is it defined in regulations which apply specifically to home health agencies at 42 C.F.R. Part 484. The Secretary has published regulations at 42 C.F.R. Part 488 which address immediate jeopardy level deficiencies in skilled nursing facilities. There, "immediate jeopardy" is defined to mean:

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. I find that this definition is applicable in the context of home health agencies as well, in the absence of any home health agency-specific definition of the term. ⁽²⁾ Home health agencies and skilled nursing facilities provide similar services to Medicare beneficiaries. It would be illogical to define "immediate jeopardy" or "immediately jeopardizes" differently as they affect the two classes of providers or beneficiaries in general.

CMS determined that Petitioner's failure to comply with the condition of participation at 42 C.F.R. § 484.30 was so egregious as to constitute immediate jeopardy. This regulation governs skilled nursing services that are provided by a home health agency and requires an agency to provide such services by or under the supervision of a registered nurse and in accordance with a patient's plan of care. CMS concluded that Petitioner's noncompliance comprised numerous failures by Petitioner and its staff to comply with a standard of compliance stated at 42 C.F.R. § 484.30(a). The standard identifies the duties of a home health agency's registered nurse:

The registered nurse makes the initial evaluation visit, regularly re-evaluates the patient's nursing needs, initiates the plan of care and necessary revisions, furnishes those services requiring substantial and specialized nursing skill, initiates appropriate preventive and rehabilitative nursing procedures, prepares clinical and progress notes, coordinates services, informs the physician and other personnel of changes in the patient's condition and needs, counsels the patient and family in meeting nursing and related needs, participates in in-service programs, and supervises and teaches other nursing personnel.

CMS determined that Petitioner failed to comply with this standard - and with the overall condition of participation at 42 C.F.R. § 484.30(a) - in the following respects:

• In instances involving four patients, identified in the report of the February survey as Patients #s 2, 4, 12, and 16, Petitioner failed to ensure that skilled nursing care was provided to the patients in accordance with their plans of care. CMS Ex. 1, at 51 - 58.

• Petitioner failed to ensure that its staff re-evaluated patients' nursing needs in providing care to patients identified in the report of the February survey as Patients #s 1, 2, and 23. Id. at 58 - 67.

• In an instance involving Patient # 1, Petitioner's nursing staff failed to initiate necessary revisions to the patient's plan of care. Id. at 67 - 69.

• Petitioner failed to ensure that its registered nurse initiated preventive procedures for Patient # 2. Id. at 69 - 72.

• In instances involving six patients who are identified as Patients #s 1, 2, 4, 12, 15, and 16, Petitioner failed to ensure that its registered nurse informed the patients' physicians of changes in their conditions and failed to coordinate the administration of services to these patients. Id. at 72 - 85.

• In one instance, involving Patient # 2, the registered nurse failed to teach appropriate feeding techniques to other nursing personnel. Id. at 85 - 88.

These allegations are set forth under headings designated as "tags" consisting of Tags 170, 172, 173, 175, 176, and 178. Id. at 51 - 88.

The evidence offered by CMS to support these tags is described in detail in the report of the February survey. CMS Ex. 1, at 51 - 88. It is not necessary for me to recite that evidence verbatim here because Petitioner did not timely contest most of it. Petitioner timely challenged a few of the specific allegations of noncompliance that are made in the survey report at paragraphs: 2.a., 2.c., and 4.c. of Tag 170; 3 and 6.f. of Tag 172; Tag 175; and 3 and 6 of Tag 176. ⁽³⁾ With the exception of Tag 175, which Petitioner challenged in its entirety, Petitioner's disputes with the evidence offered by CMS consist of challenges only to portions of tags. Indeed, Petitioner offered no timely challenge to Tags 173 and 178. I conclude that, even if I were to find in Petitioner's favor as to all of the challenged allegations, the evidence offered by CMS still would be sufficient to establish that Petitioner did not comply with the requirements of 42 C.F.R. § 484.30. Moreover, the unchallenged evidence of Petitioner's noncompliance is sufficient to establish an unrebutted case of an immediate jeopardy level deficiency because there is clear evidence of at least a potential for serious harm to patients who were under Petitioner's care.

A comparison of some of the specific allegations of noncompliance which are not disputed by Petitioner, with those which Petitioner does dispute, clearly shows that the bulk of CMS's allegations of noncompliance are undisputed. And, the undisputed allegations plainly depict an immediate jeopardy level noncompliance with a participation requirement. For example, Tag 170 of the report of the February survey makes specific allegations that Petitioner failed to provide care to its patients in accordance with these patients' plans of care. The supporting evidence, summarized in the survey report, shows that Petitioner's staff failed to carry out instructions by physicians to: perform tests on patients; ensure that patients were receiving appropriate medications; and provide prescribed treatments. The tag additionally charges Petitioner's staff with failures to make requisite assessments of patients' conditions and to notify physicians of significant changes in patients' conditions. The specific and undisputed allegations of noncompliance in the tag include the following:

• Treatment goals for Patient # 4 included maintaining oxygen saturation levels above 92 percent and blood sugar levels within established parameters of 70 - 200. Notwithstanding, Petitioner's staff failed to measure oxygen saturation levels or blood sugar levels. CMS Ex. 1, at 53 - 54.

• The nurse who provided care to Patient # 4 suspected that the patient was not taking medications in compliance with the treating physician's orders. Problems noted by the nurse included a failure by the patient to achieve pro-time levels for blood coagulation within a therapeutic range (indicating a failure by the patient to take Coumadin consistent with the physician's order) and serious medication interactions. Yet, the physician was not notified of these problems within six weeks of the inception of care. Id. at 54.

• Patient # 4's care plan required changing the patient's tracheostomy tube monthly. The registered nurse did not document changing the tube until September 15, 2003, two weeks after it was due to be changed. Id. at 55.

• There was no evidence that the registered nurse reviewed Patient # 4's medication to determine exactly what the patient was taking and when the patient was taking it. Id. at 55 - 56.

• On October 14, 2003 a physician ordered that the levels of Patient # 2's thyroid stimulating hormone (TSH) be checked in three to four weeks. There was no documentation in the patient's records to show that this had been done. Id. at 56.

• Patient # 12 displayed difficulty coping, as is evidenced by anxiety, confusion, and disorientation. Petitioner's staff made no assessment or intervention relating to the patient's coping skills. Id. at 57 - 58.

Petitioner timely disputed the evidence of its noncompliance at Tag 170 only in the following respects:

• The report alleges that there is no documentation in the patient records of Patient # 16 to establish that a skilled nursing visit was made to the patient, as scheduled, on December 20, 2003, for the purpose of patient assessment, medication regime review, and filling the patient's medication planner. CMS Ex. 1, at 52 - 53. Petitioner produced a document which it purports to be proof that the visit took place. P. Ex. 16.

• The report alleges that Petitioner failed to follow up on a physician's order dated September 19, 2003 that a hospital bed be provided to Patient # 2. CMS Ex. 1, at 56 - 57. According to the report, Petitioner did not follow up on this order until November 6, 2003 when the patient fell out bed. Id. Petitioner does not disagree with these facts but argues that there was no immediate jeopardy as of the date of the survey because the bed was, in fact, delivered prior to the survey. Petitioner's amended pre-hearing brief at 16 - 17.

CMS argues that P. Ex. 16, relied on by Petitioner to prove that the December 20, 2003 nursing visit to Patient # 16 took place, is a highly suspect document of little credibility. The document is dated December 30, 2004, suggesting that it was created after the fact and is not a contemporaneous record of a visit that actually took place, and it is mis-dated to boot. Moreover, it was not provided to surveyors when requested at the time of the survey. I agree with CMS that this is not a very persuasive document. But, even if I were to accept it as probative, the fact remains that most of the allegations of noncompliance made at Tag 170 were not challenged timely by Petitioner.

Furthermore, the fact that some of the events described in the survey report took place prior to the survey, including Patient # 2's fall from bed, does not detract from the image of noncompliance that is portrayed by the survey report. The report depicts a pattern of noncompliance with the requirements of 42 C.F.R. § 484.30 which extended for weeks leading up to the date of the survey. That some of the events described in the report took place prior to the survey shows that the noncompliance as of the time of the survey was not isolated but was ongoing. Indeed, the history of noncompliance depicted in the survey report only strengthens the conclusion that Petitioner had a serious deficiency in its operation.

The deficiencies that are not timely disputed are, in and of themselves, so egregious as to comprise immediate jeopardy for the patients to whom Petitioner provided care. They describe a widespread failure on the part of Petitioner's nursing staff to carry out the duties of a registered nurse. The evidence offered by CMS and not disputed by Petitioner establishes that Petitioner's nursing staff failed to function as a vital connection between the patients served by Petitioner and the patients' physicians. Patients' needs were not assessed. Administration of medication was not monitored. Tests that had been ordered by physicians were not performed. Treatments that had been prescribed were not supplied. And, changes in the patients' conditions were neither assessed nor reported. These patients were utterly dependent on Petitioner's staff to provide requisite care. It is apparent that failure to do so jeopardized their well-being.

I do not find it necessary to make similar analyses with respect to the other tags that are cited pursuant to 42 C.F.R. § 484.30 in the report of the February survey. As I discuss above, Petitioner has not timely disputed the bulk of the deficiency findings made under these tags. And, even if I accepted as true its explanations for the relatively few allegations that it does dispute, they do not detract from the overall picture and gravity of noncompliance depicted in the report of the February survey.

2. Petitioner proved that it removed immediate jeopardy by February 28, 2004.

As a matter of law, CMS would have had the authority to terminate Petitioner's participation in Medicare immediately upon completion of the February survey, given the presence of an immediate jeopardy level deficiency. Act, section 1891(e)(1). CMS was not obligated to offer Petitioner an opportunity to correct its deficiency prior to terminating Petitioner's participation. Id. However, CMS afforded Petitioner an opportunity to remove the immediate jeopardy that existed in its operations, and, then, waited until February 28, 2004 before it effectuated termination of Petitioner's participation. In doing so, CMS fundamentally altered the question which must be answered in order to decide whether it had authority to terminate Petitioner's participation in Medicare.

The Act - and the authority it confers on CMS to terminate a provider's participation in Medicare - is remedial and not punitive. CMS may only terminate a provider's participation for noncompliance with participation requirements if that provider is not in compliance with requirements as of the termination date. It is not authorized to terminate for past noncompliance. Here, CMS moved forward the date of termination from February 5, 2004, the date when Petitioner was found to manifest an immediate jeopardy level deficiency, until February 28, 2004. Petitioner could only be terminated if it continued to manifest an immediate jeopardy level deficiency as of February 28, 2004. Thus, in order to decide whether CMS had the authority to terminate Petitioner's participation, the question is not whether Petitioner manifested an immediate jeopardy level deficiency as of February 5, 2004, it is whether Petitioner continued to manifest one as of February 28, 2004.

If Petitioner no longer manifested an immediate jeopardy level deficiency as of February 28, 2004, then by law it would have until six months from February 5, 2004 to correct all of the deficiencies that were identified at the February survey. The section of the Act which governs home health agencies requires CMS to allow a deficient agency six months to correct a deficiency or deficiencies before terminating that provider's participation in Medicare unless that provider manifests one or more immediate jeopardy level deficiencies. Act, sections 1891(e)(1), (2). The Act clearly distinguishes between immediate jeopardy and non-immediate jeopardy level deficiencies. It provides that CMS may terminate immediately a home health agency which has an immediate jeopardy level deficiency. Act, section 1891(e)(1). But, where an agency manifests a deficiency or deficiencies that are not at the immediate jeopardy level, then CMS may not terminate the agency's participation for a period of six months during which time the agency has the opportunity to correct its deficiencies. CMS has the authority to impose intermediate sanctions against that agency during the six month period as a means of inducing the agency to correct its deficiencies. Act, section 1891(e)(2). Only if, at the end of the six month period, the agency continues to manifest any deficiencies, may CMS then terminate the agency's participation in Medicare. Id. ⁽⁴⁾

Thus, if Petitioner abated its immediate jeopardy by February 28, 2004, there would not be a basis for terminating its participation within the six month period. Its remaining deficiencies - to the extent they continued to exist - would be subject to the requirements of section 1891(e)(2) and not section 1891(e)(1). CMS might impose intermediate sanctions against Petitioner for any non-immediate jeopardy deficiencies that persisted but it would lack the authority to terminate Petitioner's participation in Medicare until the expiration of the six month period. At the end of that period CMS would have the authority to terminate Petitioner's participation in Medicare if Petitioner continued to manifest any deficiencies, whether or not remaining deficiencies were at the immediate jeopardy level.

CMS gave Petitioner the opportunity to submit a plan of correction to the Colorado survey agency explaining how it had addressed and corrected the immediate jeopardy level deficiency. P. Ex. 1, at 2. Had Petitioner submitted a plan that was found to be acceptable by the Colorado survey agency, then the normal practice would have been to resurvey Petitioner in order to determine whether the immediate jeopardy continued to exist or was abated. Id. The Colorado survey agency decided that the several plans that Petitioner submitted were inadequate and, for that reason, did not resurvey Petitioner prior to February 28, 2004. ⁽⁵⁾ As a consequence, Petitioner's participation in Medicare was terminated without its operations being resurveyed in order to determine whether the immediate jeopardy had been abated.

I stress that neither the Colorado survey agency nor CMS was obligated to resurvey Petitioner or even to accept a plan of correction from Petitioner. As I have found, the Act authorizes CMS to terminate a home health agency's participation in Medicare immediately upon its determination that immediate jeopardy exists in the agency's operations. There is nothing in the Act or in the regulations which obligates CMS to give a facility that has an immediate jeopardy level deficiency an opportunity to correct its deficiency and there is certainly nothing in the Act or the regulations which requires CMS or a State survey agency to resurvey that agency before termination is effectuated. It was entirely a matter of discretion whether the Colorado survey agency would accept any of Petitioner's plans of correction or resurvey Petitioner prior to February 28, 2004.

However, the rejection of Petitioner's several plans of correction by the Colorado survey agency did not slam shut the door on Petitioner's opportunity to show that it had removed, by February 28, 2004, the immediate jeopardy that existed in its operations. At this stage the issue is not whether Petitioner gave a plan of correction to the Colorado survey agency that satisfied the agency's concerns, or whether that entity properly rejected the several plans that Petitioner submitted to it, but whether Petitioner removed the immediate jeopardy by February 28. If, in fact, Petitioner eliminated the immediate jeopardy deficiency by February 28, 2004, then there would not exist a statutory basis to terminate its participation on that date regardless of the Colorado survey agency's opinion as to whether Petitioner's plan or plans of correction were satisfactory and regardless whether Petitioner was resurveyed on or prior to that date.

The case before me requires a de novo hearing and an independent decision. I cannot simply accept the judgment of the Colorado survey agency as to whether Petitioner submitted an acceptable plan of correction. Indeed, the issue of whether Petitioner's plan or plans were acceptable to the Colorado survey agency is, at this point, essentially irrelevant. The question that I must decide is one of objective evidence. Does the evidence that Petitioner presented, including the contents of its plans of correction, establish that it abated its immediate jeopardy level deficiency by February 28, 2004?

The finding of an immediate jeopardy level deficiency as of February 5, 2004 creates a presumption of continuing immediate jeopardy level noncompliance by Petitioner. It is up to Petitioner to prove by the preponderance of the evidence that it abated immediate jeopardy by the termination date of February 28, 2004.

The findings of noncompliance with 42 C.F.R. § 484.30 cited in the report of the February survey were based on the care that Petitioner provided to seven identified patients. CMS Ex. 1, at 51 - 88. Had any of these patients remained under Petitioner's care, answering the question of whether Petitioner abated immediate jeopardy would begin with deciding whether Petitioner addressed and resolved the problems that were associated with these patients' care. However, by February 28, 2004, six of the seven patients were no longer being cared for by Petitioner and its staff and CMS made no assertions that the specific corrective actions that Petitioner pledged to take with regard to the seventh patient were in any respect inadequate to deal with the concerns that CMS raised at the February survey.

Of course, this does not resolve the issue of whether immediate jeopardy persisted as of February 28, 2004. The errors and omissions that the Colorado survey agency identified in the care that Petitioner provided to the patients were signs of an underlying problem. It was the systemic failure by Petitioner to provide nursing care as is required by 42 C.F.R. § 484.30 that was the basis for the finding of immediate jeopardy. The errors and omissions in providing care to the seven identified patients were evidence of that systemic failure.

Thus, Petitioner could only abate immediate jeopardy if it resolved the problems that caused the errors and omissions to occur. Petitioner's burden in this case is to prove that it had done so by February 28, 2004. The weight of the evidence establishes that, by that date, Petitioner corrected the practices that supported the immediate jeopardy deficiency determination. Petitioner reorganized its operations in a way that eliminated the broad problems that led to the immediate jeopardy deficiency finding in the February survey report. Additionally, Petitioner undertook steps to address the specific allegations of noncompliance that were made in the report.

Petitioner's reorganization, and the steps it undertook to reform its operations, included the following actions:

• Petitioner adopted a plan for reorganization of its operations designed to address the following problems: supervisory practices including orientation, skills competency validation, monitoring performance and knowledge of patient caseload; knowledge of nursing processes, job descriptions and coordination/case management processes; agency resources; nurses' workloads; and emergency backup staffing arrangements. P. Ex. 13, at 6 - 8.

• Petitioner restricted the admission of new patients so as to allow it to dedicate resources to its reorganization. P. Ex. 14, at 6, par. 27; P. Ex 9, at 7.

• Petitioner instituted a complete review of its patient records in order to ensure that patients received care in accordance with their respective plans of care. P. Ex. 14, at 6, par. 28.

• Petitioner retained the services of a quality improvement nurse in order to review, beginning with January 2004, 100 percent of Petitioner's nurse visit records. Id. at 7, par. 29.

• Petitioner instituted in-service training of all of its nursing personnel in order to ensure that they understood their obligations, Petitioner's policies, and its reorganization of nursing responsibilities. Id. at 7, Par. 30; P. Ex. 13, at 6. Petitioner's records document that these training sessions were held. P. Ex. 13, at 133 - 158.

• Petitioner arranged for a special audit of all of its current medical records on February 26, 2004, by its clinical operations directors and coordinators, to ensure that all of its patients whom it had identified as being potentially at risk were not at risk. P. Ex. 14, at 7, par. 31. This audit was designed to ensure that: orders were obtained and implemented; care plans were in place and implemented; physicians were notified of any change of a patient's conditions; registered nursing assessments were performed as ordered and as need identified; and that care plans incorporated individualized parameters for each patient so as to identify changes in condition requiring immediate notification of the registered nurse or the agency. Id. at 7, par. 32.

• Petitioner hired a rehabilitation supervisor to oversee all therapy services, in order to free its clinical operations directors and coordinators to address nursing issues. P. Ex. 9, at 7.

• Petitioner hired a social worker to assist in resource management and patient care issues. Id. at 8 - 9.

The aforesaid actions by Petitioner attacked the fundamental problems that were identified at the February survey. By reviewing its patient records and seeking to identify patients who were at risk, Petitioner acted to ensure that none of its patients slipped through the cracks. In hiring a quality improvement nurse Petitioner introduced into its operation a person whose specific job duties included reviewing the work performed by others and ensuring that this work met the needs of patients and carried out the orders issued by patients' physicians. In hiring other personnel Petitioner freed its nursing staff to perform duties that were uniquely in their province. Its retraining efforts were designed to bring its employees up to speed in terms of their duties and obligations.

The specific corrections that Petitioner described in its final plan of correction also addressed the findings of noncompliance that were made at the February survey. P. Ex. 9, at 1 - 46. In so concluding I stress that I am not deciding that the Colorado survey agency ought to have accepted this plan. I am concerned solely with the question of whether the corrections listed in Petitioner's reorganization and in the plan of correction addressed the deficiencies that were identified at the February survey. Petitioner argues persuasively that it implemented these corrections. The plan documented actions by Petitioner which, among other things, included: identifying and assessing patients who were at risk; establishing procedures for audits of patients' records; counseling and retraining staff; expanding Petitioner's continuing education program for its staff; and describing the duties of the quality improvement nurse. Id.

The testimony that is in the record of this case includes that of Linda Pero, R.N. CMS Ex. 2, at 1 - 11; Tr. at 36 - 63. Ms. Pero is the program manager for community based programs of the Colorado survey agency and was the lead surveyor during the February survey. CMS Ex. 2, at 1, par. 1 - 2. Ms. Pero testified that the plans of correction and accompanying documents submitted by Petitioner did not demonstrate compliance with participation requirements. The major uncorrected deficiencies, described by Ms. Pero as the "key areas" that she was concerned about, were failures by Petitioner's staff to assess patients, to follow patients' care plans, and to establish preventive measures to keep patients safe. Tr. at 45 - 46. She asserted, more specifically, that Petitioner had not satisfied her that it had removed immediate jeopardy, because:

• There was nothing which showed that Petitioner had identified which patients were at risk, how Petitioner would remove the risk, and how Petitioner would ensure that all skilled nursing visits and ordered tasks were completed. Id. at 40.

• Petitioner's policies and procedures contained nothing which described when an assessment visit may or may not be made to a patient. Id. at 42.

• Petitioner failed to implement a plan to ensure that a nurse regularly reassessed a patient to determine if there were changes in the patient's nursing needs. Id. at 43.

• Petitioner failed to establish compliance with a requirement that its staff evaluate patients and notify physicians of changes in the patients' conditions. Id.

In fact, close review of the evidence offered by Petitioner shows that it met all of these concerns. The plan of correction and Petitioner's reorganization plan document specific actions to ensure that patients are assessed appropriately, that prescribed care is delivered to them, and that physicians are notified of changes in the patients' conditions.

Ms. Pero's assertion notwithstanding, the record establishes that Petitioner reviewed its patient database and identified those patients who were at risk. E.g., P. Ex. 9, at 6. Petitioner reviewed at-risk patients' records to ascertain whether skilled nursing visit notes matched their physicians' plans of care. The records also were reviewed for documentation that appropriate assessments were being performed. Petitioner directed that nursing follow up visits be done immediately as patient needs were identified. Id.

The evidence also proves, contrary to Ms. Pero's assertion, that Petitioner implemented a system of reviews to ensure that services were being provided to its patients as ordered and as needed. In addition to hiring a quality improvement nurse, Petitioner ordered that its patients' charts be audited every 60 days. P. Ex. 9, at 6. It also ordered that each visit to a patient be reviewed by the quality improvement nurse within two days of Petitioner's receipt of the record of that visit. Id. at 11. It directed that the charts be analyzed to ensure that skilled nursing care is provided to patients in accordance with the patients' plans of care and sound nursing judgment. Id. at 6. It scheduled quarterly supervisory visits to patients by registered nurse supervisors to ensure that nursing practice was in accord with standards of care and also to ensure that plans of care were being followed. Id.

Petitioner also implemented a plan to have staffers review charts for visit frequency. P. Ex. 9, at 8. It assigned two employees to review the estimated five charts per day that Petitioner's nursing staff was expected to generate, thereby ensuring that missed visits would be identified immediately. Id.

The evidence offered by Petitioner also rebuts Ms. Pero's assertions that Petitioner had not addressed the need for patient reassessments and that it had not established a protocol for making patient assessments. Petitioner directed its staff to make reassessments of its patients at each visit. P. Ex. 9, at 14. It established a procedure for generating immediate responses to notifications from patients, members of patients' families, or from staff concerning perceived problems being experienced by patients. Id. Petitioner purchased a voice mail system so that messages could be left with its clinical personnel. Id. at 22.

Finally, the evidence establishes that, contrary to Ms. Pero's testimony, Petitioner took steps to ensure that its staff would notify a patient's physician of changes in a patient's condition or other events that required notification to be made. Petitioner counseled those nurses whose care was discussed in the survey report on the importance of coordinated care and physician notification. P. Ex. 9, at 34. Petitioner educated all of its nurses regarding the vital need for ongoing communication with physicians and other disciplines. Id. at 32. Petitioner's education efforts included in-service training which Petitioner conducted on February 20, 2004. Petitioner also educated its management personnel in the importance of appropriate physician notification. Id. at 33. The in-service training given to the nursing staff included discussion of written plans of care, what is included in a plan of treatment, how to handle verbal change orders, and the implications of fax and computer generated orders. Id. at 32.

3. CMS is not at this time authorized to terminate Petitioner's participation in Medicare.

Petitioner proved that it had abated immediate jeopardy in its operations by February 28, 2004. CMS is not authorized to terminate Petitioner's participation based on the presence of an immediate jeopardy level deficiency inasmuch as none was present as of February 28, 2004. See Act, sections 1891(e)(1), (2).

That is not to suggest that CMS may not impose intermediate remedies against Petitioner or that CMS may not eventually terminate Petitioner's participation in Medicare. The findings of noncompliance (or other findings made at a resurvey) may yet be the basis for terminating Petitioner's participation in Medicare six months after February 5, 2004. The February survey identified five condition level deficiencies in Petitioner's operations. CMS may terminate Petitioner's participation if any of these deficiencies is found to exist at the end of six months or if new deficiencies arise that are not corrected at the end of those six months.

All that I hold in this decision is that CMS may not terminate Petitioner's participation in Medicare based on the persistence of immediate jeopardy through February 28, 2004. Whether other remedies are appropriate or may be appropriate are not issues that were raised by the parties and I do not address them here.

Steven T. Kessel

Administrative Law Judge

1. At the April 14, 2004 hearing I advised the parties that the section of the Act which appeared to govern participation and termination of a home health agency is section 1866(b). Tr. at 9 - 12. That section generally governs participation of providers in Medicare. Section 1891(e) specifically applies to home health agencies and, in this case, its more specific language applies.

2. In a notice letter to Petitioner dated February 12, 2004, CMS advised Petitioner that immediate jeopardy was present because Petitioner's failure to comply with a condition of participation constituted "an immediate and serious threat to the health and safety of . . . [Petitioner's] patients." The definition of immediate jeopardy utilized in the notice letter is, for practical purposes, indistinguishable from that which is contained in 42 C.F.R. § 488.301.

3. In its original hearing request Petitioner disputed none of the findings of noncompliance. I afforded Petitioner the opportunity to file a supplemental hearing request. Pre-Hearing Order, March 16, 2004. On March 18, 2004, Petitioner filed a supplemental hearing request in which it disputed only some of the allegations of noncompliance that were made in the survey report. Supplemental Request for Hearing, March 18, 2004, at 1 - 3. However, Petitioner then filed as a proposed exhibit the affidavit of M. Elaine Graves, RN, BSN, MA (P. Ex. 15), along with other proposed exhibits. These proposed exhibits, and Petitioner's pre-hearing brief, contain much broader challenges to CMS's allegations of noncompliance than were stated in the supplemental hearing request. On April 8, 2004, I issued a ruling in which I limited Petitioner's case to those issues raised in Petitioner's initial and supplemental hearing requests. Ruling, April 8, 2004. In this decision I do not address any argument that Petitioner failed to make in its initial and supplemental hearing requests.

4. This analysis is different from comments I expressed to the parties in my opening remarks at the April 14, 2004 hearing. Tr. at 9 - 12. At the time I was under the impression that this case was governed solely by the provisions of section 1866 of the Act and I was not aware of the sections of the Act which apply specifically to home health agencies.

5. Petitioner argues strenuously that the Colorado survey agency unfairly rejected Petitioner's several plans of correction. I make no findings in this decision concerning the propriety of the Colorado survey agency's actions because I lack authority to decide that question. Furthermore, the fairness of that agency's actions are irrelevant to the issue that I must decide, whether Petitioner eliminated immediate jeopardy in its operations by February 28, 2004.