SUBJECT:

Jaynell's Home Health Care Services, Inc.,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

I decide that Petitioner, Jaynell Home Health Care Services, Inc., failed to comply substantially with conditions that are stated at 42 C.F.R. �� 484.18 and 484.44 and which govern a home health agency's participation in the Medicare program. The Centers for Medicare & Medicaid Services (CMS) was authorized to terminate Petitioner's participation in Medicare as a home health agency in light of Petitioner's compliance failures.

I. Background

The facts that I recite in this section are undisputed. Petitioner is a home health agency with a business address in Clinton, Louisiana. On November 26, 2001, surveyors employed by the Louisiana Department of Health and Hospitals (Louisiana State survey agency) conducted a survey of Petitioner in order to determine whether Petitioner was complying with Medicare conditions of participation. The surveyors concluded that Petitioner was not complying substantially with two conditions of participation. Based on these findings CMS determined to terminate Petitioner's participation in Medicare. Petitioner requested a hearing and the case was assigned to me for a hearing and a decision.

I decided to expedite a hearing in this case. I scheduled a hearing to take place in New Orleans, Louisiana on April 24, 2002. However, the parties agreed that the hearing could be conducted by telephone. Therefore, on April 24, 2002, I conducted a hearing by telephone. At the hearing, CMS offered the testimony of Maureen King, a surveyor who participated in the November 26, 2001 survey. Tr. at 14 - 21. Petitioner offered the testimony of Elma Montgomery, Petitioner's director of nurses. Tr. at 22 - 32. Additionally, CMS offered as evidence exhibits that are identified as CMS Ex. 1 - CMS Ex. 9. I received these exhibits into evidence. Petitioner produced various proposed exhibits which it sought to offer into evidence. At the hearing I advised Petitioner that it had not properly identified or paginated these proposed exhibits. I gave Petitioner the opportunity to resubmit its proposed exhibits with its post-hearing brief. It has done so. It identified its proposed exhibits as Petitioner (P.) Ex. 1 - P. Ex. 22. I am receiving these exhibits into evidence.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues in this case are whether:

1. Petitioner failed to comply substantially with one or more conditions which govern its participation in the Medicare program as a home health care agency; and,

2. CMS is authorized to terminate Petitioner's participation in Medicare.

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. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

1. Petitioner failed to comply substantially with conditions which govern its participation in Medicare as a home health care agency.

A home health care agency must comply substantially with conditions of participation that are set forth in regulations at 42 C.F.R. Part 484 in order to remain eligible to participate in the Medicare program. These conditions of participation are set forth in the governing regulations as broadly stated principles of compliance. Subparts of these conditions, known as "standards" enunciate the specific compliance requirements with which a home health care agency must comply. Failure by a home health care agency to comply with a standard of participation may be so egregious as to establish a failure by the agency to comply with the overall condition of which the standard is a subpart.

The Louisiana State survey agency surveyors who conducted the November 26, 2001 survey of Petitioner concluded that Petitioner was not complying substantially with two conditions of participation. CMS Ex. 3. These conditions are set forth at 42 C.F.R. �� 484.18 and 484.55. The condition of participation that is set forth at 42 C.F.R. � 484.18 requires, among other things, that a home health agency must provide care which:

follows a written plan of care established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric medicine.

The condition of participation that is set forth at 42 C.F.R. � 484.55 requires that:

[e]ach patient must receive, and a . . . [home health agency] must provide, a patient-specific, comprehensive assessment that accurately reflects the patient's current health status and includes information that may be used to demonstrate the patient's progress toward achievement of desired outcomes. The comprehensive assessment must identify the patient's continuing need for home care and meet the patient's medical, nursing, rehabilitative, social, and discharge planning needs. . . . The comprehensive assessment must also incorporate the use of the current version of the Outcome and Assessment Information Set (OASIS) items, using the language and grouping of the OASIS items, as specified by the Secretary.

The surveyors based their conclusions that Petitioner failed to comply with these two conditions of participation on their review of the treatment records that Petitioner maintained for four patients who were in its care. These patients are identified in the survey report as Patients #s 1, 2, 3, and 4. CMS Ex. 3 at 2 - 4. The surveyors focused specifically on the plans of care that Petitioner created for these residents and on associated items including OASIS assessments. They concluded that Petitioner was remiss in: completing assessments that were required as integral elements of the patients' plans of care; and, performing the tasks required by the patients' plans of care. They found that Petitioner had failed to document the heights and weights of Patients #s 1, 2, 3, and 4 on these patients' OASIS assessments. Id. at 4. They found that, in the case of Patient # 2, there was no physician's order in the patient's plan of care specifying the frequency of visits to the patient by Petitioner's staff. Id. at 2. The surveyors found that there were no documented weights in Patient # 3's progress notes notwithstanding that the patient's plan of care listed weight loss as a goal for the patient. Id. Similarly, they found in the case of Patient # 4 that Petitioner's staff had not documented the patient's weight even though the patients' plan of care listed weight loss as a goal. Id.

CMS offered additional prima facie evidence that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 484.18 with respect to the care that it provided to Patient # 2. The patient's plan of care, signed by a nurse on October 10, 2001 and by a physician on November 1, 2001, provided that the patient would be seen by a skilled nurse twice during the first week of care and then, once per week for eight subsequent weeks. CMS Ex. 6 at 4. However, Petitioner's staff visited the patient three times per week up until the date of the survey. CMS Ex. 3 at 2. There was no amendment to the patient's plan of care or approval by a physician for this increased frequency of visits.

It is a fundamental requirement of 42 C.F.R. � 488.55 that a home health agency provide each of its patients with a comprehensive assessment that reflects the patient's health status and needs. The prima facie evidence introduced by CMS shows that Petitioner failed to satisfy this requirement because it failed to weigh Patients #s 1, 2, 3, and 4 as a necessary prerequisite of assessing these patients' weights.

The prima facie evidence offered by CMS shows that Petitioner's failures to comply with the explicit requirements of 42 C.F.R. �� 484.18 and 484.55 were so substantial as to comprise a failure on Petitioner's part to comply with the requirements of these conditions. Potentially, the patients under Petitioner's care could suffer substantial harm as a consequence of Petitioner's omissions. The number of episodes of noncompliance identified by the surveyors is evidence that Petitioner's failures were pervasive and not mere isolated occurrences.

I have examined the evidence that Petitioner produced and the arguments Petitioner made to refute CMS's prima facie case of noncompliance with 42 C.F.R. �� 484.18 and 484.55. I find that this evidence and Petitioner's arguments do not refute that case.

Petitioner argues that it was "not allowed to produce the information, which would have removed" the surveyor's findings concerning Petitioner's compliance with the requirements of 42 C.F.R. � 484.18. Petitioner's post-hearing brief at 2. I am not persuaded that the surveyors denied Petitioner the opportunity to show them how it was complying with this condition. But, even had they done so, Petitioner was given the opportunity to prove its compliance at the hearing that I conducted.

In its post-hearing brief, Petitioner argues that it produced documentation with respect to Patient # 3 that establishes that it complied with the requirements of 42 C.F.R. � 484.18 when it provided care to the patient. Petitioner's post-hearing brief at 2. The document on which Petitioner relies, P. Ex. 6, is a plan of care for Patient # 3. I note that it is signed and dated by a physician on January 4, 2002, more than a month after the November 26, 2001 survey. P. Ex. 6. The plan specifically states as a goal that "Client will Lose Weight within 60 days." Id. at 1. Nothing in the plan or in any other document offered by Petitioner shows how Petitioner would meet that goal if it did not record the patient's weight. Nor did Petitioner offer any evidence to show that it did, in fact, record the patient's weight.

Petitioner did not rebut the additional evidence that CMS offered to show that it had not complied with the requirements of 42 C.F.R. � 484.18. Petitioner did not rebut the prima facie evidence that its plan of care for Patient # 2 did not comport with the actual number of visits to that patient performed by Petitioner's staff. Petitioner produced an exhibit, P. Ex. 4, which includes a physician's order that Patient # 2 be seen three times a week for a period of 60 days. That order has a physician's signature which is dated November 1, 2001, the same date as the patient's plan of care which specifies that the patient be seen twice during the first week and then once per week for the following eight weeks. CMS Ex. 6 at 4. The physician's signature on the plan of care appears to be identical to the signature on the order produced by Petitioner.

I do not find the order produced by Petitioner to be credible evidence that Patient # 2's treating physician ordered that the patient's plan of care be modified to permit three visits per week. As things stand, there are two different physicians' orders that contradict each other and that were executed on the same day. Without additional explanation the plan of care that Petitioner prepared for Patient # 2 (CMS Ex. 6) might just as easily reflect the treating physician's final orders for that resident as does the order contained in P. Ex. 4. Indeed, the document which should reconcile any differences between physician's orders is the patient's plan of care. I would have accepted Petitioner's representation that the patient's physician ordered three visits per week had Petitioner modified the patient's plan of care to reflect a change in orders to that effect. But, the plan of care was not modified and, failing that, I do not find that Petitioner proved that it had orders which justified the number of visits that its staff paid to Patient # 2.

Petitioner offered no evidence to prove that it recorded weights for Patient # 4. Therefore, the prima facie evidence offered by CMS as to this resident stands unrebutted.

Petitioner also failed to offer any proof that would rebut the prima facie evidence of its noncompliance with the requirements of 42 C.F.R. � 484.55. The allegations of Petitioner's noncompliance with this regulation center on evidence showing that Petitioner failed to record the weights of Patients #s 1, 2, 3, and 4, despite being required to assess these patients' weights. Petitioner offered no evidence to establish that its staff weighed the patients or recorded their weights.

Indeed, Petitioner admits that its staff did not weigh any of the patients whose care is at issue. Petitioner contends that its staff could not weigh these patients due to the patients' medical problems. Petitioner argues that it satisfied the requirements of 42 C.F.R. �� 484.18 and 484.55 by using "other methods" to measure patients' weight losses or gains. Petitioner's post-hearing brief at 3. These "other methods", according to Petitioner, consisted of measuring edema and auscultating lung sounds. Id.

I am not persuaded that charting a patient's edema or auscultating that patient's lung sounds is an adequate substitute for weighing the patient. Petitioner's witness, Ms. Montgomery, testified that measuring a patient's fluid was "more important" than measuring the patient's body fat. Tr. at 28. I find that testimony to be unpersuasive because she did not explain how measuring fluid would enable a home health agency to determine whether the patient was gaining, maintaining, or losing weight.

At the hearing I asked Ms. King to explain how a home health agency would chart a patient's weight loss if it could not weigh the patient due to the patient's medical problems. Ms. King testified that an agency could use anthropometric methods, such as measuring the girth of a patient's limbs, to track the patient's weight. Tr. at 20. I accept this testimony as a reasonable explanation for the circumstances under which a home health agency might determine a patient's body weight using alternatives to simply weighing the patient. As Ms. King explained, a decrease in limb girth would be consistent with a loss of weight. By contrast, Petitioner offered no explanation of why tracking edema or auscultating lung sounds are acceptable ways for determining weight.

I note, furthermore, that Petitioner presented no evidence to show that it discussed with the patients' physicians its plan to use alternative methods to measure patients' weight. Nor did Petitioner offer any evidence to show that it modified its patients' plans of care to reflect its changed thinking about weighing the patients. One would expect that, if an agency were unable to use traditional methods of taking a patient's weight, it would notify the patient's physician, would obtain his or her permission to use an anthropometric method of weighing the patient, and would document the consultation and the physician's order. Tr. at 20 - 21.

Finally, Petitioner offered no evidence to prove that it systematically measured the patients' fluids. Thus, even if fluid measurement is an acceptable substitute for weighing a patient, Petitioner offered no evidence to prove that its staff made such measurements of its patients or that its staff recorded systematically the results of any measurements.

There are some references to "edema" in some of the patient records offered by Petitioner as evidence. But, I can identify nothing in those records that shows that Petitioner was systematically recording the presence or absence of edema and attempting to correlate that presence or absence with patients' body weight.

2. CMS is authorized to terminate Petitioner's participation in Medicare.

CMS may terminate a provider's participation in the Medicare program where that provider is not complying with one or more conditions of participation. Social Security Act, section 1866(b)(2); 42 C.F.R. � 489.53(a)(1). CMS established a basis to terminate Petitioner's participation in Medicare because it established a prima facie case, which Petitioner did not rebut, that Petitioner failed to comply substantially with conditions of participation for home health agencies that are stated at 42 C.F.R. �� 484.18 and 484.55.

Steven T. Kessel

Administrative Law Judge