SUBJECT:

Comprehensive Professional Home Visits,

Petitioner,

Centers for Medicare & Medicaid

DECISION

For the reasons stated below, I conclude that Comprehensive Professional Home Visits (Petitioner) was not in substantial compliance with Medicare conditions of participation governing home health agencies. Accordingly, Centers for Medicare & Medicaid Services (CMS) was authorized to terminate Petitioner's Medicare participation agreement.

BACKGROUND

At all relevant times in this case, Petitioner operated as a home health agency (HHA) and was a Medicare provider of home health services located in Vallejo, California.

By letter dated July 28, 1999, CMS notified Petitioner that it no longer met the requirements for participation as a provider of home health services in the Medicare program established under Title XVIII of the Social Security Act (Act), based on the findings of a June 22, 1999 survey conducted by the California Department of Health Services (CDHS). Based on the results of the survey, CMS informed Petitioner that CMS was terminating Petitioner's Medicare provider agreement effective August 6, 1999. However, the CMS letter noted that the termination could potentially be retroactively avoided if by August 2, 1999, Petitioner were to submit to CMS's regional office and to the CDHS credible documentation evidencing correction of all of the deficiencies cited on the standard survey report HCFA Form 2567, and if CMS could verify such corrections through a resurvey.

Petitioner subsequently responded to CMS's letter with documentation alleging correction of the deficiencies. After review of the documentation, CMS informed Petitioner that it found no basis for revising its determination. Petitioner's Medicare provider agreement was terminated August 6, 1999.

CMS alleges that Petitioner was out of compliance with seven Medicare conditions of participation. CMS determined that the documented deficiencies substantially limited Petitioner's capacity to render adequate care, or adversely affected patient health and safety. In addition, CMS alleges that these deficiencies were of such a character as to pose immediate jeopardy to the health or safety of Petitioner's patients.

In a letter dated August 28, 1999, Petitioner filed a request for an administrative hearing to review CMS's determination, and the case was assigned to me for hearing and decision. CMS was represented by the Office of General Counsel, Department of Health and Human Services (DHHS). Petitioner's request for hearing was signed by its administrator, Eligia (Ellie) O. Aguilar.

CMS subsequently filed a case readiness report and motion to dismiss. CMS alleged that Petitioner's hearing request should be dismissed because its request for hearing did not dispute any of the specific findings and conclusions which resulted in the termination action taken by CMS as required by the regulations at 42 Code of Federal Regulations (C.F.R.) � 498.40. Petitioner's request for hearing, signed by Ms. Aguilar, simply indicated that, "I would like to explain to the Board the specific issues regarding the 12 identified clients, what contributed to the general outcome of the audit, the claimed non compliance of our HHA administration and show exhibits to point out why we believe the audit outcome should have been otherwise." Petitioner's initial hearing request.

Petitioner filed a response to CMS's motion to dismiss entitled, "Motion to pursue alternative dispute resolution." In addition to requesting that the case be referred for mediation, Petitioner also indicated that it made corrections to bring Petitioner into compliance with the regulatory requirements for which they were cited at 42 C.F.R. �� 484.14, 484.16, and 483.36. Petitioner also indicated that it had documents which were not provided during the survey. Petitioner also complained that the State surveyor was "unprofessional, abusive of power and non businesslike."

I conducted a prehearing conference on March 9, 2000, during which I informed Ms. Aguilar that Petitioner had the right to be represented by counsel. I informed Ms. Aguilar of the legal complexities that arise in such cases and the benefits of having experienced legal representation. However, Ms. Aguilar indicated that she and Petitioner were unable to afford an attorney, and therefore, she would represent Petitioner. CMS declined to participate in alternative dispute resolution in this case.

I also informed Petitioner that portions of her report of readiness could be interpreted as admissions that Petitioner was not in compliance with participation requirements. Petitioner requested and was granted an opportunity to file an amended hearing request. I denied CMS's motion to dismiss.

After a number of extensions, Petitioner subsequently filed an amended hearing request, in which she indicated that Petitioner "had addressed all deficiencies to make them compliant." Petitioner further noted that "most of our deficiencies are clerical." In addition, Petitioner again complained that the State surveyor's attitude contributed to its inability to provide specific information that the surveyor requested during the course of the survey.

A prehearing conference was conducted on November 30, 2000, at which time a hearing was scheduled to take place on February 26, 2001, and the parties were provided deadlines for the exchange of exhibits, and witness lists. CMS submitted its documents as required by my prehearing order. Petitioner filed its exhibits three weeks late. On February 2, 2001, CMS filed an objection to Petitioner's exhibits indicating that none of the exhibits offered by Petitioner were properly marked or numbered, were duplicative, and in many instances merely indicated "same exhibit as HCFA's." ⁽¹⁾ CMS further argued that the exhibits should not be accepted or in the alternative, argued that the exhibits be returned to Petitioner for proper identification in accordance with the Civil Remedies Division guidelines and a new hearing date be set. CMS's February 2, 2001 motion.

Petitioner's exhibits were returned to Petitioner for proper identification. I conducted another prehearing conference and rescheduled the hearing date. Petitioner subsequently filed a letter in which she made non-specific allegations of discrimination by the surveyor and CMS. Petitioner again noted that it could not afford an attorney and proposed to have CMS provide it with evidence that Petitioner was treated differently than other HHAs. Petitioner also alleged that counsel for CMS provided incorrect legal information to this tribunal. Petitioner's letter of March 12, 2001.

CMS filed a response to Petitioner's letter on March 16, 2001, which accurately described what was said during the course of the prehearing conference and supported its arguments with case citations. CMS argued that Petitioner should not be allowed to present additional evidence relating to other HHAs surveyed as the evidence was irrelevant. CMS further argued that Petitioner had failed to state a basis for the alleged discrimination, and that Petitioner had not filed a complaint of discrimination against CMS or the State of California or requested investigation of the allegations. Further, CMS argued that Petitioner's complaints of discrimination were not properly before this tribunal under 42 C.F.R. � 498.3. CMS cited the case of Prescribed Care, Inc., DAB CR492 (1997), to support its argument that I did not have the authority to address Petitioner's complaints that it was not provided a follow-up survey. Further, CMS argued that such a decision is not an initial determination, and therefore, not subject to review by an Administrative Law Judge.

Another prehearing conference was conducted on March 20, 2001, at which time I informed Petitioner that I did not have jurisdiction under the regulations to review her allegations of discrimination, and my authority was limited to the review of initial determinations as defined by 42 C.F.R. � 498.3. I further informed Petitioner that my review was limited as to whether Petitioner was in compliance with participation requirements and, if not, whether the remedy imposed by CMS was reasonable. I also ruled that the additional evidence Petitioner proposed to include relative to the treatment of other HHAs was not relevant to the issues over which I had jurisdiction. The hearing was rescheduled for September 17 - 21, 2001.

It must be noted that, contrary to Petitioner's assertions, counsel for CMS has not made misrepresentations as to the facts or the law relative to this case. To the contrary, counsel for CMS has been cooperative, patient, and helpful, to the extent possible, in explaining the proceedings to Petitioner. To that end, CMS even informed Petitioner of the option of reapplying for certification under a new provider number while this litigation continued. Petitioner's representative indicated that she was aware of that option but she chose not to proceed in that manner.

The hearing did not take place as scheduled on September 17, due to the terrorist attacks on September 11, 2001. Limitations on travel and delays with the mail delayed the hearing on this matter. The hearing was subsequently rescheduled for May 14 - 17, 2002, and conducted in San Francisco, California.

Prior to the hearing, CMS filed a motion to dismiss arguing that the case was moot because Petitioner's HHA license had been revoked for failure to comply with California law. At the time Petitioner was terminated from participation in Medicare, it met the statutory requirements under California law and was duly licensed to operate as a HHA. Petitioner's State license to operate a HHA expired on September 15, 2001, and was not renewed. Petitioner's license was subsequently revoked on February 11, 2002. CMS argued that the loss of license rendered Petitioner ineligible to participate as a Medicare and Medicaid provider. CMS asserted that because Petitioner did not have a valid HHA license, even if Petitioner prevailed on all of the issues preserved for hearing, Petitioner, as a matter of law, could not be readmitted as a Medicare program provider.

Petitioner filed a response to CMS's motion in which it argues that "[t]he hearing was requested specifically by the 'Petitioner' to show due cause that the decision of licensing to suspend the services of the agency was irresponsible and arbitrary. We did not request for the hearing to allow us to start serving patients again, even with a suspended license." Petitioner further argued that Petitioner's license had been suspended as of August 19, 1999, and Petitioner ceased operation of the HHA at that time and did not maintain an office, staff, or payroll, and had not treated any patients as of that time. Petitioner's sole reason for pursuing the appeal appeared to be to prove that the survey findings were incorrect. Further, Petitioner appeared to argue that it did not pursue the appeal to be reinstated as a Medicare provider. CMS's motion to dismiss was denied and the case proceeded to hearing.

At hearing, CMS offered into evidence HCFA Exhibits (HCFA Exs.) 1 - 40. I note that the exhibits offered by CMS were marked with the acronym "HCFA." In this Decision, I refer to these exhibits as they were identified at the hearing. Petitioner offered into evidence Petitioner's Exhibits (P. Exs.) 1 - 25. Without objection from the parties, I admitted the exhibits into evidence.

During the hearing, CMS presented the testimony of Ms. Geraldine Bauer, a registered nurse (R.N.), who was the State surveyor who conducted the survey of Petitioner. Ms. Aguilar testified on behalf of Petitioner. Due to time constraints during the hearing, CMS did not have an opportunity to cross-examine Ms. Aguilar. Therefore, the record was held open in order to complete the cross-examination by telephone at a later date. I conducted a posthearing telephone conference on June 14, 2002, to set a time to allow CMS to conduct cross-examination and allow Petitioner to present rebuttal. During the conference call, CMS waived cross-examination of Petitioner; therefore, cross-examination of Ms. Aguilar by telephone was unnecessary. Petitioner "rested" its case, indicating that Petitioner's case was completed.

At the end of the posthearing conference, I set a schedule for the parties to submit posthearing briefs. The parties were sent a copy of the transcript (Tr.) of the hearing. CMS submitted a posthearing brief (CMS Br.), and Petitioner submitted a posthearing response brief (P. Br.). CMS did not file a reply brief.

APPLICABLE LAW

Under the Medicare program, a HHA is a public agency or private organization that primarily provides skilled nursing and other therapeutic services to patients on a visiting basis in places of residence used by the patients as their homes. See Act, sections 1861(m) and (o). Based on sections 1861(o) and 1891 of the Act, 42 C.F.R. Part 484 sets out the requirements that an HHA must meet to participate in Medicare.

These requirements, or conditions of participation, serve as the basis for survey, certification and enforcement activities, implemented by 42 C.F.R. Part 488. Under 42 C.F.R. � 488.20, CMS makes periodic determinations as to whether an HHA is in compliance with the conditions of participation and sets forth the responsibilities of State survey agencies in the review and certification of compliance.

Section 1861(m) of the Act describes the covered services that HHAs provide under the Medicare program. The statutory requirements for HHAs, including conditions of participation, are described in section 1861(o) of the Act.

The Secretary of Health and Human Services (Secretary) has issued regulations which govern the participation of HHAs in the Medicare program. These regulations are contained in 42 C.F.R. Part 484. Specifically, the provisions contained in 42 C.F.R. �� 484.10 - 484.52 set forth the Secretary's requirements for Medicare participation of HHAs and establish conditions of participation for these entities. The regulations express these conditions of participation as broadly stated participation criteria. For example, the provisions of 42 C.F.R. � 484.30, the condition of participation for skilled nursing services, states that "[t]he HHA furnishes skilled nursing services by or under the supervision of a registered nurse and in accordance with the plan of care."

The regulations also state standards of participation as subsidiary components of the conditions of participation. As an example, the standard for the duties of the registered nurse, contained in 42 C.F.R. � 484.30(a), includes but is not limited to: regular reevaluation of the patient's nursing needs; coordination of services; preparation of clinical and progress notes and informing the physician and other personnel of changes in the patient's condition and needs; and counseling the patient and family in meeting nursing and related needs.

The Secretary is required to determine whether a Medicare provider of services, including a HHA, is complying substantially with the Medicare participation requirements established by the Act and regulations. Act, section 1866(b)(2). The Secretary may terminate the participation in Medicare of a provider that the Secretary finds not to be complying substantially with participation requirements. Act, section 1866(b)(2)(A).

The process and criteria for determining whether a provider is complying substantially with Medicare participation requirements are established by regulations contained in 42 C.F.R. Part 488. The Secretary, through CMS, has entered into agreements with State survey agencies, pursuant to the Act and regulations, to conduct periodic surveys of providers, including HHAs, in order to ascertain whether the providers are complying with Medicare participation requirements. Act, section 1864(a); 42 C.F.R. �� 488.10, 488.11, and 488.20.

State survey agencies conduct surveys of HHAs and make recommendations to CMS as to whether such facilities meet federal participation requirements for the Medicare program. Id. CMS considers survey results from the State survey agencies as the bases for its determinations regarding the initial or continued participation of a HHA in the Medicare program.

In determining whether a provider is compliant with a particular condition of participation, the State survey agency evaluates the manner and degree of the provider's satisfaction of the various standards within each condition. 42 C.F.R. � 488.26(b). The State survey agency documents its findings on HCFA Form 2567, which the provider receives after the survey is completed. The State survey agency also makes a recommendation to CMS as to whether there is a basis for termination. CMS may accept or reject the recommendation after reviewing the survey findings.

CMS may terminate participation in Medicare when it determines, either on its own initiative or based on a State survey agency report, that a provider is not complying with one or more Medicare conditions of participation. See 42 C.F.R. �� 488.20, 488.24, and 488.26. Failure to comply with a condition of participation occurs where deficiencies, either individually or in combination, are "of such character as to substantially limit the provider's . . . capacity to furnish adequate care or which adversely affect the health and safety of patients . . . ." 42 C.F.R. � 488.24(b).

Where CMS determines that there is a deficiency, but that the deficiency is not so severe as to constitute a condition-level deficiency, then CMS may not terminate the provider's participation in the Medicare program without first affording the provider the opportunity to correct the deficiency. 42 C.F.R. � 488.28.

Termination of participation is a remedy intended to protect the health and safety of program beneficiaries and is not a punishment. Termination of participation should be invoked in the circumstances where a provider's deficiencies establish that the provider is substantially incapable of providing care consistent with Medicare participation requirements. Termination should not be invoked unless the evidence proving a provider's failure to comply with participation requirements established that the provider cannot provide care consistent with that which is required by the Act and regulations. CSM Home Health Services, Inc., DAB CR440 (1996), at 3.

The burden of proof in this case is governed by the decision of an appellate panel of the Departmental Appeals Board in Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEV), slip op. at 25 (D.N.J. May 13, 1999.) Under Hillman, CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner failed to comply with participation requirements. Petitioner has the burden of proving, by a preponderance of the evidence, that it complied substantially with participation requirements. Hillman, DAB No. 1611 at 3-8, (1997).

In determining whether CMS has met its burden of establishing a prima facie case, I may consider rebuttal evidence offered by Petitioner that CMS's evidence is neither credible nor relevant to the issue of Petitioner's compliance with participation requirements or that the weight of the evidence establishes that the regulatory deficiency alleged by CMS did not occur. If I conclude that the preponderance of the evidence establishes that such circumstances exist, then I will find that CMS has not met its burden of establishing a prima facie case (but rather, that its case is based on unsubstantiated allegations) and Petitioner will not be obligated to prove that it was substantially complying with participation requirements.

ISSUES

The issues in this case are: (1) whether Petitioner failed to comply with a Medicare condition of participation; and (2) if noncompliance is established, whether CMS is authorized to terminate Petitioner's participation in Medicare.

PETITIONER'S GENERAL ARGUMENTS

Petitioner argued generally throughout the hearing and its written submissions that the State surveyor abused her discretion in citing Petitioner with deficiencies during the June 29, 1999 survey. Petitioner argued that the State surveyor abused her power to cite the HHA as deficient and that "[t]his power is very dangerous when afforded to an unprofessional, non-informed, arrogant, inconsistent, neglectful, conniving and erratic mind." P. Br. at 5. Petitioner further argued that the facility was on 100 percent OASIS ⁽²⁾ forms at the time of the survey, and that "[w]e were never informed that only the old forms were being surveyed." Id.

Whether or not the CMS surveyor "abused her discretion" and was "arrogant" is not relevant in reaching the proper decision in this case. Petitioner's representative was informed of this fact from the earliest prehearing conferences I convened in this case. Petitioner was informed that what is relevant is whether or not CMS presented legally sufficient, reliable, and credible evidence of deficiencies based on the applicable regulations. Petitioner was further informed that it would have an opportunity to prove that the survey findings were incorrect and that Petitioner was in fact compliant with participation requirements. These are the only matters I can consider. Individual personalities and "bad blood" between the parties simply do not factor into my ultimate decision in this case.

Similarly, I make no specific findings as to whether or not Petitioner was on OASIS, or any other form of recordkeeping at the time of the survey. Regardless of the system used, the issue before me is whether or not Petitioner met conditions of participation, and where appropriate, provided proper documentation under the regulations.

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 separately numbered heading. I discuss each Finding in detail.

IMMEDIATE JEOPARDY (G-TAG 164)

1. Petitioner failed to comply with a condition of participation at 42 C.F.R. � 484.18(b).

The evidence advanced by CMS established that Petitioner failed to comply with a condition of participation at 42 C.F.R. � 484.18. The applicable regulation at 42 C.F.R. � 484.18(b) (G-Tag 164) provides in part:

(b) Standard: Periodic review of plan of care . . . . Agency professional staff promptly alert the physician to any changes that suggest a need to alter the plan of care.

Patient No. 8

Patient No. 8 is a 71-year-old female with a history of congestive heart failure, chronic atrial fibrillation, diabetes, chronic renal insufficiency, and hypertension. HCFA Ex. 15, at 23; Tr. 184.

Based on record reviews and interviews completed during the June 22, 1999 survey, the surveyor from the CDHS observed that Patient No. 8's plan of treatment required, among other things, that she receive insulin injections twice a day, a finger stick blood glucose test every skilled nursing visit, and that her physician was to be notified if her blood sugar level was below 60 mg./dl. and over 200 mg./dl. ⁽³⁾ HCFA Ex. 15, at 7 - 8; Tr. 185.

CMS alleges that Petitioner failed to follow the plan of treatment, thus endangering the health and safety of Patient No. 8 at the immediate jeopardy level. 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 patient. 42 C.F.R. � 489.3.

Specifically, the surveyor indicated that this insulin dependent patient could have suffered a diabetic coma if she received the incorrect dosage of insulin and that such an injury likely would have occurred because the physician was not notified about the elevated blood glucose levels. Tr. 205 - 206. During three separate skilled nursing visits on May 31, 1999, June 2, 1999, and June 4, 1999, the patient's blood sugar level was 224, 288, and 225, respectively. Tr. 186 - 190; HCFA Exs. 10 - 12. Despite the plan of treatment requirement that Patient No. 8's physician be contacted if blood sugar levels rose above 200, there is no indication in the skilled nursing visit notes that Petitioner contacted the physician regarding the elevated blood sugar levels. HCFA Ex. 15, at 10 - 12; Tr. 185 - 190.

Additionally, according to CMS, on at least two occasions, Patient No. 8 was given sliding scale insulin ⁽⁴⁾ when Petitioner did not have a physician's order approving the use of sliding scale insulin. Tr. 190. Moreover, Petitioner failed to regularly monitor Patient No. 8'sblood glucose levels, as required by the plan of treatment. Tr. 193; HCFA Ex. 15, at 8.

Petitioner argues that Patient No. 8's physician in fact wanted to be contacted if Patient No. 8's blood sugar was over 350 mg./dl. But, according to Petitioner, a medical clerk incorrectly wrote 200 mg./dl. P. Br. at 37.

The plan of treatment for Patient No. 8 clearly indicates that the physician was to be contacted if the patient's blood glucose levels fell below 60 mg./dl. or rose above 200 mg./dl. HCFA Ex. 15, at 8. Conversely, there is no evidence in the record that the physician was to be contacted if the patient's blood glucose was over 350 mg./dl. as Petitioner asserts. Petitioner did not call the physician to testify as such nor did she provide an affidavit to prove her assertions. Similarly, Petitioner failed to call the medical clerk to substantiate its claim that the medical clerk incorrectly wrote 200 mg./dl. instead of 350 mg./dl. Thus, I can place no weight on Petitioner's unsubstantiated assertions in its hearing brief relative to this issue.

Petitioner admits its failure to obtain a physician's order for sliding scale insulin, but explains that the R.N. "thought she had done the proper report back to the doctor." HCFA Ex. 15, at 33. Petitioner further explains that on June 18, 1999, the skilled nurse did not conduct a blood glucose test because the client had just eaten lunch and as a result, the test would have been inaccurate. P. Br. at 37-38.

I find that Petitioner's arguments and explanations are wholly inadequate to meet its burden. Petitioner has a duty under the applicable regulation at 42 C.F.R. � 484.18(b) to promptly alert the physician of any changes that suggest a need to alter the care plan. Petitioner failed to monitor and more closely supervise the insulin requirements of Patient No. 8. As a result, the health of Patient No. 8 was potentially compromised because Petitioner failed to notify the physician about changes in the patient's blood glucose levels and insulin protocol.

Therefore, I find that CMS established a prima facie case that Petitioner failed to comply with 42 C.F.R. � 484.18(b) in that Petitioner failed to promptly alert the physician of any changes that suggested a need to alter the care plan. I also find that Petitioner did not rebut CMS's prima facie case by a preponderance of the evidence. Petitioner's failure to alert the physician of changes in the condition of Patient No. 8 presented a situation which was likely to cause serious injury, harm, impairment, or death. I sustain CMS's deficiency finding on participation requirement 42 C.F.R. � 484.18(b) (G-Tag 164) at the immediate jeopardy level.

Patient No. 6

Patient No. 6 is a 64-year-old female with a history of respiratory failure, congestive heart failure, chronic obstructive pulmonary disease, status post tracheotomy, and laryngeal cancer with metastasis to the lung. HCFA Ex. 13, at 9; Tr. 212.

Petitioner indicated in its home visit notes of June 1, 1999, that Patient No. 6 was "[o]n home oxygen 40% trach mist most of the time. . . . " HCFA Ex. 13, at 8. However, the home health referral form from the hospital to Petitioner contained a physician's order indicating that Patient No. 6 was on "continuous oxygen." Id. at 6. In addition, the physician's orders did not indicate the oxygen concentration or the mode of delivery. CMS alleges that Petitioner was out of compliance with 42 C.F.R. � 418.18(b), in that Petitioner failed to resolve the conflict between the physician's order on the home referral form and Petitioner's skilled nursing notes of June 10, 1999. Tr. 212 - 214.

The regulations at 42 C.F.R. � 418.18(b) require a facility to alert the physician as to any changes that suggest a need to alter the plan of care. CMS argues that the obvious contradiction in the patient's oxygen requirements should have been brought to the attention of the physician so that, if necessary, appropriate changes to the care plan could have been made. CMS further alleges that these deficiencies placed Patient No. 6 in immediate jeopardy, in that it presented a situation that was likely to cause serious harm, injury, impairment, or death.

Petitioner argues that it was clear that Patient No. 6 was to receive continuous oxygen, and that "[t]here never was a question to this. It was all over the chart from the very start." P. Br. at 40; See HCFA Ex. 13, at 8.

It may well have been clear to Petitioner that Patient No. 6 was to receive continuous oxygen; however, it was not apparent what the physician ordered relative to oxygen concentration and mode of delivery requirements because he did not indicate these requirement on the home health referral form. Id. at 6. Indeed, in a fax dated June 17, 1999, from Ellie Aguilar (agency owner) to Dr. Evelyn Canio (Patient No. 6's physician), Petitioner admitted that, "RN Constantino neglected to confirm with you the 02 concentration, . . . we apologize and accept the responsibility for this omission." Id. at 28.

I agree with CMS that Petitioner should have taken the time to clarify the physician's instructions in order to prevent potentially serious harm to Patient No. 6. Indeed, the surveyor testified that because of Patient No. 6's chronic obstructive pulmonary disease, an incorrect oxygen concentration could have inhibited the patient's ability to breathe. Tr. 220.

In addition, the surveyor found that Patient No. 6 was not receiving pureed food as ordered by her physician. The surveyor also found that Petitioner did not ascertain whether methicillin resistant Staphylococcus aureus (MRSA) ⁽⁵⁾ precautions were necessary upon release from the hospital.

As to the issue of the pureed diet, Petitioner maintains that Patient No. 6 and her care provider (her son) were trained and instructed on pureed diet in the hospital, and that "[t]he client or the care provider (son) did not tell the SN [skilled nurse] during admission that they did not have money to buy a blender." P. Br. at 39.

In response to the allegations relative to the MRSA precautions, Petitioner argues that the surveyor does not understand the difference between MRSA precaution and MRSA isolation, and "is totally confused about MRSA [p]recaution."

Petitioner misses the point on both arguments. CMS's chief complaint under 42 C.F.R. � 484.18(b) is that Petitioner failed to notify the physician about differences in the regimen prescribed for the patient under the care plan and the patient's actual care and practice.

For example, when Petitioner discovered during its home visit of June 16, 1999, that Patient No. 6 was not eating pureed food, Petitioner should have informed the physician immediately so that, if necessary, appropriate interventions could have been taken. Because Patient 6 had a tracheo-esophageal fistula, not eating the proper pureed food, as ordered, created the risk that she could aspirate food into her lungs and develop aspiration pneumonia. Tr. 218 - 221.

There seems to be some disagreement among the parties as to the precise definition of MRSA ⁽⁶⁾ and Patient No. 6's proper MRSA protocol. The exact definition of MRSA is not determinative in this case. In order to be in compliance with 42 C.F.R. � 484.18(b), Petitioner was required to inquire with the physician regarding Patient No. 6's MRSA status. Patient No. 6's physical therapy referral form from the hospital clearly indicated "MRSA precautions." HCFA Ex. 13, at 12. Nonetheless, there was no mention of MRSA precautions in Petitioner's patient home visit notes. Id. at 8. The failure to clarify with the physician whether the patient was still on MRSA precautions could have exposed others to MRSA. Tr. 215 - 217.

I find that CMS established a prima facie case that Petitioner failed to comply with 42 C.F.R. � 484.18(b) relative to the issues involving Patient No. 6. I also find that Petitioner's arguments fall far short of rebutting the prima facie case established by CMS relative to Patient No. 6. Petitioner's failure to comply with the requirements of participation in this instance presented a situation which was likely to cause serious injury, harm, impairment, or death. I sustain CMS's deficiency finding on participation requirement 42 C.F.R. � 484.18(b) (G-Tag 164) at the immediate jeopardy level.

As noted previously, CMS provided the sworn testimony of Nurse Bauer at hearing and Petitioner provided the testimony of Ms. Aguilar who is also a Registered Nurse. I found the testimony of Ms. Bauer during the hearing to be credible as it was clearly supported by the evidence in the case. While Ms. Aguilar was sincere in expressing her concern for the patients in her charge and her attempts to comply with participation requirements, her testimony was not supported by the record and did not establish that Petitioner was in compliance or that CMS's findings were erroneous.

I find that CMS established that Petitioner was out of compliance with 42 C.F.R. � 484.18(b) at the immediate jeopardy level. Petitioner's failure to comply with the requirements of participation relative to the care of Patient No. 6 and Patient No. 8 presented situations which were likely to cause serious injury, harm, impairment, or death.

I further find that Petitioner did not rebut CMS's prima facie case by a preponderance of the evidence.

NON-IMMEDIATE JEOPARDY TAGS

I have examined closely all of the evidence of record to determine whether Petitioner was complying with participation requirements. As detailed above, I am satisfied that Petitioner was out of compliance with at least one participation requirement at the immediate jeopardy level. Petitioner was cited for having failed to meet over 40 requirements for participation in the Medicare program at the non-immediate jeopardy level. These deficiencies (seven Medicare conditions of participation) were identified as "Tags" and refer to particular regulatory requirements as follows:

Acceptance of Patients, 42 C.F.R. � 484.18 -- G-Tag 156, G-Tag 157, G-Tag 158, G-Tag 159, G-Tag 163, G-Tag 164, G-Tag 165.

Organization, Services & Administration, 42 C.F.R. � 484.14 -- G-Tag 122, G-Tag 123, G-Tag 125, G-Tag 128, G-Tag 132, G-Tag 133, G-Tag 136, G-Tag 137, G-Tag 140, G-Tag 143, G-Tag 144, G-Tag 145, G-Tag 147, G-Tag 148, G-Tag 149, G-Tag 150.

Skilled Nursing Services, 42 C.F.R. � 484.30 -- G-Tag 170, G-Tag 172, G-Tag 175, G-Tag 176, G-Tag 177.

Clinical Records, 42 C.F.R. � 484.48 -- G-Tag 235, G-Tag 236.

Home Health Aide Services, 42 C.F.R. � 484.36 -- G-Tag 202, G-Tag 224, G-Tag 229.

Evaluation of the Agency's Program, 42 C.F.R. � 484.52 - G-Tag 242, G-Tag 244, G-Tag 245, G-Tag 246, G-Tag 247, G-Tag 250, G-Tag 251.

Group of Professional Personnel, 42 C.F.R. � 484.16 - G-Tag 151, G-Tag 152, G-Tag 154.

Because I have sustained CMS's immediate jeopardy citation, I will not discuss the non-immediate jeopardy Tags for a number of reasons. First, the applicable regulations authorize termination of a provider agreement if a provider is found to be out of substantial compliance with even a single program requirement. 42 C.F.R. � 488.456(b) (1)(i). Second, I have the discretion to exercise judicial economy and not discuss every alleged deficiency. Beechwood Sanitarium, DAB No. 1824, at 22 (2002). Finally, Petitioner has admitted the existence of numerous deficiencies in her own exhibits. See P. Ex. 4. In addition, the record in this case also establishes that Petitioner has conceded the existence of numerous deficiencies.

A few examples of Petitioner's concessions and admissions of deficiencies are as follows:

42 C.F.R. � 484.18, G-Tag 158, Patient Nos. 6 and 8. Petitioner admitted in a letter that Petitioner did not follow the physician's orders with respect to Patient No. 6's oxygen use. HCFA Ex. 13, at 28 and Tr. 112 - 113.

Petitioner provided a written statement that Petitioner's HHA R. N. did not send a supplementary physician's order regarding the sliding scale insulin coverage for Patient No. 8. This failure was also a deficiency under G-Tag 159 for Patient No. 8. HCFA Ex. 15, at 33; Tr. 120.

42 C.F.R. � 484.14, G-Tag 136. Petitioner conceded that it did not implement an effective budgeting and accounting system by indicating "[w]e had a budget but it was adopted to the previous office that we had. When the surveyor asked for a copy, I was not able to hand it to her. I did not know how to access the budget in the computer." P. Ex. 4, at 1; Tr. 264, 266.

42 C.F.R. � 484.14, G-Tag 143, Patient No. 7. Petitioner conceded that it did not include specific vital sign parameters for Patient No. 7 on the Home Health Aide's Plan of Care. P. Ex. 6, at 11.

42 C.F.R. � 484.30, G-Tag 176, Patient No. 4. Petitioner concedes that it did not report changes in the patient's urine to his physician as required by this standard. P. Ex. 8, at 22.

42 C.F.R. � 484.36, G-Tag 229, Patient No. 9. Petitioner admits that it did not comply with the standard that requires, in part, that the R.N. must make an on-site visit to the patient's home no less frequently than every two weeks. Tr. 432. Petitioner stated that "[w]e had HHA [home health aide] supervisory visits but not of the required no [number] of visits. We will endeavor more to be compliant." P. Ex. 15, at 8; Tr. 441.

CMS argues that the evidence demonstrates that the admitted deficiencies, individually or in combination, are of such a character as to substantially limit Petitioner's capacity to furnish adequate care to patients and adversely affect patient health and safety. I find this argument compelling and supported by the record in this case.

2. CMS was authorized to terminate Petitioner's participation in the Medicare program.

CMS may terminate participation in Medicare when it determines, either on its own initiative or based on a State survey agency report, that a provider is not complying with one or more Medicare conditions of participation. See 42 C.F.R. �� 488.20, 488.24, and 488.26. Petitioner has admitted the existence of numerous deficiencies. Moreover, CMS has established by a preponderance of the evidence that Petitioner's conduct relating to the condition of participation at 42 C.F.R. � 484.18, Plan of Care, did not comply substantially with Medicare requirements. The evidence advanced by CMS clearly proves that Petitioner's inability to comply with conditions of participation directly affected the health and safety of Petitioner's patients at the immediate jeopardy level.

I therefore find that CMS was authorized to terminate Petitioner's participation in the Medicare program. 42 C.F.R. � 488.456(b)(1)(i).

Alfonso J. Montano

Administrative Law Judge

1. Centers for Medicare & Medicaid Services was formerly named Health Care Financing Administration (HCFA). The agency's name change became effective July 5, 2001. 66 Fed. Reg. 35,437 (2001).

2. The acronym OASIS stands for "Outcome and Assessment Information Set." OASIS was designed to provide computerized storage, access, and analysis of patients in HHAs throughout the country, and create a standard nationwide system for connecting HHAs to State agencies for the purpose of information exchange.

3. The normal range for blood sugar is about 60 mg./dl. to 120 mg/dl., depending on when a person last ate.

4. Insulin dose regimens are given four times a day according to changing levels of blood sugar.

5. Used to describe those examples of this organism that are resistant to commonly used antibiotics. If MRSA organisms are passed on to someone who is already ill, then a more serious infection may occur in that individual .

6. Geraldine Bauer, the State surveyor, defined MRSA as Multi Resistant Staphylococcus Aureus. Tr. 215. Ellie Aguilar, Petitioner's owner, defined MRSA as Methicillin Resistant Staphylococcus Aureus. P. Br. at 40. I checked several on-line computer research sources including the Centers for Disease Control, all of which confirmed Petitioner's version of the definition.