Date: January 25, 1999

In the Case of:

Desert Hospital,
Petitioner,

- v. -

Health Care Financing Administration.

Docket No. C-97-474
Decision No. CR567

I decide that the Health Care Financing Administration (HCFA) is authorized to impose remedies against Petitioner, Desert Hospital, effective March 20, 1996, consisting of denial of payment for new admissions and civil money penalties. I base this decision on my conclusion that, as of March 20, 1996, Petitioner was not complying substantially with federal participation requirements.

Summarized briefly, my decision is as follows:

• HCFA is authorized to impose remedies, including denial of payment for new admissions and civil money penalties, where it is shown that a long-term care facility is not complying substantially with participation requirements.

• Petitioner is a long-term care facility which provides skilled nursing services to beneficiaries of the Medicare program. HCFA determined to impose remedies against Petitioner beginning on March 20, 1996. HCFA based its determination to impose remedies on findings made by surveyors who are employed by the California Department of Health Services (California State survey agency). These findings were made at a compliance survey of Petitioner which was completed on March 20, 1996. In some respects, the findings that were made at the survey that was completed on March 20, 1996 incorporate findings that surveyors made at a 1994 compliance survey of Petitioner and at a compliance survey of Petitioner that the surveyors completed on February 6, 1996.

• HCFA established that Petitioner employed a physical therapist assistant to provide care to its residents. The physical therapist assistant worked under the general supervision of a registered physical therapist. The physical therapist assistant at times communicated directly with a resident's treating physician and obtained verbal treatment orders from the physician. The physical therapist assistant at times performed assessments of residents and revised or changed the treatment that had been ordered for residents. On at least one occasion, the physical therapist assistant provided care to a resident that had not been ordered in writing by the resident's physician.

• The care which was provided by the physical therapist assistant did not comply with requirements of California State law governing physical therapy. California State law prohibits a physical therapist assistant from: communicating directly with a patient's treating physician to obtain a treatment order from that physician; performing an evaluation of a patient; or devising or revising a patient's treatment plan.

• Petitioner's failure to assure requisite supervision of the physical therapist assistant consistent with the requirements of California law contravened the requirements of 42 C.F.R. § 483.20(d)(3)(i) in that the physical therapy services provided by Petitioner failed to comply with professional standards of quality.

• Petitioner's failure to assure requisite supervision of the physical therapist assistant contravened the requirements of 42 C.F.R. § 483.45(b), in that the physical therapy services that were being provided by Petitioner were not provided under the written order of a physician by qualified personnel.

• Petitioner failed to discharge a responsibility that resident care policies be implemented pursuant to the requirements of 42 C.F.R. § 483.75(i)(2)(i), in that Petitioner's medical director failed repeatedly to implement resident care policies governing the provision of physical therapy services.

• HCFA established a prima facie case, which Petitioner did not rebut, that as of March 20, 1996, Petitioner was not complying substantially with one or more Medicare participation requirements. HCFA is authorized to impose remedies against Petitioner, effective March 20, 1996, which may include a denial of payment for new admissions and civil money penalties.

I. BACKGROUND

A. Background facts

The facts that I recite here are not disputed by the parties. Petitioner is a long-term care facility which is located in Palm Springs, California. Petitioner was surveyed on behalf of HCFA from January 29 - February 6, 1996, by surveyors employed by the California State survey agency. The surveyors found Petitioner to be failing to comply substantially with various federal participation requirements. The results of that survey are not at issue in this case. Petitioner was again surveyed on March 20, 1996. At the resurvey, the surveyors found that Petitioner was not complying with three participation requirements. HCFA Ex. 1. The surveyors concluded that Petitioner was not complying with the requirements of:

• 42 C.F.R. § 483.20(d)(3)(i), in that Petitioner allegedly failed to assure that the physical therapy services it provided met professional standards of quality. HCFA Ex. 1 at 6 - 11;

• 42 C.F.R. § 483.45(b), in that Petitioner allegedly failed to assure that specialized rehabilitative services were provided under the written order of a physician by qualified personnel. HCFA Ex. 1 at 11 - 13; and

• 42 C.F.R. § 483.75(i), in that Petitioner allegedly failed to assure that its medical director assumed responsibility for implementation of resident care policies and the coordination of medical care in Petitioner's facility. HCFA Ex. 1 at 13 - 15.

HCFA determined to impose remedies against Petitioner consisting of: a civil money penalty in the amount of $100 per day for each day of Petitioner's asserted noncompliance with participation requirements; and, denial of payment for new admissions. The effective date for implementation of these remedies was March 20, 1996. Petitioner requested a hearing from the findings of deficiencies and the imposition of remedies against Petitioner.

Initially, I decided this case based on a motion for summary disposition filed by Petitioner. In my first decision, I found that HCFA failed to give Petitioner adequate notice of its determination to impose remedies against Petitioner. Desert Hospital, DAB CR448 (1996). HCFA appealed my decision. An appellate panel of the Departmental Appeals Board reversed my decision and remanded the case back to me for a hearing and a decision on the merits. Desert Hospital, DAB No. 1623 (1997).

I held an in-person hearing in Palm Springs, California, on February 24 and 25, 1998. At that hearing, HCFA called the following individuals as witnesses:

• Connie M. Schagunn. Transcript (Tr.) at 46 - 167. Ms.Schagunn is employed by the California State survey agency as a surveyor. She was the team leader of the survey team which performed the March 20, 1996 revisit survey of Petitioner.

• Barbara Sherman. Tr. at 172 - 250. Ms. Sherman is employed by the California State survey agency as a supervisor. She participated as a surveyor in the March 20, 1996 revisit survey of Petitioner.

• Edna Daufen. Tr. at 251 - 321. Ms. Daufen is employed by the California State survey agency as a physical therapy consultant.

Petitioner called the following individual as a witness:

• Jo Anne Schader. Tr. at 334 - 368. Ms. Schader was employed by Petitioner as its director of subacute and specialty services at the time of the March 20, 1996 revisit survey.

At the in-person hearing, HCFA offered exhibits, which I identified and received into evidence as HCFA Ex. 1 - HCFA Ex. 38. Petitioner offered one exhibit which I identified and received into evidence as P. Ex. 1. Additionally, Petitioner attached several "exhibits" (Exhibits A - G) to its posthearing brief. Petitioner's Exhibits A - G all are excerpts from official legal texts and are not evidence so much as they are authorities cited by Petitioner in support of its legal arguments. I do not receive into evidence Petitioner's Exhibits A - G, although I have reviewed and considered them.

HCFA offered an additional exhibit into evidence after the completion of the in-person hearing. This is HCFA Ex. 39. Petitioner objected to my receiving this exhibit into evidence. I have decided to receive HCFA Ex. 39 as an additional HCFA exhibit. I discuss my ruling on the admission of HCFA Ex. 39 below, at Part II of this decision.

B. Governing law

Under both the Social Security Act (Act) and applicable regulations, Petitioner is classified as a long-term care facility. In order to participate in Medicare, a long-term care facility must comply with federal participation requirements. The statutory requirements for participation are set forth at sections 1819 and 1919 of the Act. Regulations which govern the participation of a long-term care facility are published at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act give the Secretary of the United States Department of Health and Human Services (Secretary) authority to impose remedies against a long-term care facility for failure by the facility to comply substantially with participation requirements. The remedies that are authorized by sections 1819 and 1919 include denial of payment for new admissions and civil money penalties.

The Secretary has delegated to HCFA and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. 42 C.F.R. Part 488. The Part 488 regulations provide that facilities which participate in Medicare may be surveyed on behalf of HCFA by state survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. §§ 488.10 - 488.28. The regulations contain special survey provisions for long-term care facilities. 42 C.F.R. §§ 488.300 - 488.335. Under the Part 488 regulations, a state or HCFA may impose remedies against a long-term care facility, which include civil money penalties or denial of payment for new admissions, where a state survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430. The remedies may be imposed for each day that the facility is not in substantial compliance with participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430, 488.454.

The term "substantial compliance" is defined by relevant regulation. "Substantial compliance" is defined to mean:

a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

42 C.F.R. § 488.301.

A facility against which a remedy is imposed has the right to a hearing before an administrative law judge at which the facility may challenge the findings of noncompliance which are the basis for imposing a remedy or remedies against that facility. See 42 C.F.R. §§ 498.3(b)(12); 498.5. A facility may request a hearing as to the amount of a civil money penalty that HCFA may determine to impose. But, a facility has no right to a hearing as to HCFA's choice of remedies. 42 C.F.R. §§ 488.408(g)(2); 498.3(d)(11), (14). Thus, for example, a facility may not contest at an administrative hearing HCFA's exercise of discretion to impose the remedy of denial of payment for new admissions against that facility based on a finding by HCFA that the facility has not complied substantially with one or more participation requirements. Of course, if a facility establishes at a hearing that it was not deficient in complying with participation requirements, then HCFA would be without authority to impose any remedy against that facility.

II. RULING ON ADMISSION INTO EVIDENCE OF HCFA EX. 39

I decide to receive as evidence HCFA Ex. 39. I find the exhibit to be relevant to deciding the question of law that is posed by this case. I find further that Petitioner will not be prejudiced by my receipt of HCFA Ex. 39 into evidence in light of the safeguards against prejudice that I imposed here.

HCFA's assertion that the physical therapist assistant who was employed by Petitioner was performing his duties in a manner that contravened the requirements of California law is a predicate to HCFA's argument that Petitioner was not complying with federal participation requirements. I cannot decide the merits of HCFA's allegations of noncompliance without first deciding how California law regulates the duties that are performed by physical therapist assistants.

The meaning of California law is addressed by HCFA Ex. 39. HCFA offers HCFA Ex. 39 as an official interpretation of the California statute and regulations which govern the activities of physical therapists and physical therapist assistants in California. On its face the exhibit is relevant to resolving questions concerning the correct interpretation of California law governing the practice of physical therapy. The exhibit is a letter on the letterhead of the Physical Therapy Board of California. HCFA Ex. 39 at 1. It is signed by Steven K. Hartzell, Executive Officer. Id. at 3. It contains an interpretation of California law and recites that the interpretation "has been presented to, and approved by, the Practice Issues Committee of the Physical Therapy Board of California." Id.

HCFA Ex. 39 is relevant to interpreting the California State statute which governs physical therapy. However, as I discuss below at Finding 2, HCFA Ex. 39 is not relevant to deciding the correct interpretation of regulations which governed supervision of physical therapist assistants which were in effect as of March 20, 1996, the date when the resurvey of Petitioner was completed. The regulations which were in effect as of March 20, 1996, were amended and revised subsequently. See HCFA Ex. 11; Petitioner's posthearing brief, Exhibit C. HCFA Ex. 39 provides an interpretation of current regulations, but not of the regulations that were in effect as of March 20, 1996.

HCFA did not offer HCFA Ex. 39 timely. HCFA produced the exhibit many months after the expiration of the deadline that I had established for the parties to exchange their proposed exhibits. HCFA did not produce the exhibit at the February 24 - 25, 1998 in-person hearing. It waited until May 1998 to offer the HCFA Ex. 39, approximately three months after the completion of the in-person hearing at which HCFA rested its case.

HCFA's dilatory production of HCFA Ex. 39 is a strong basis for me to reject the exhibit from receipt into evidence. However, on balance, this ground for rejection of the exhibit is outweighed by reasons for admitting the exhibit. The fact that HCFA Ex. 39 is an official interpretation of California law weighs in favor of my receiving it into evidence despite the fact that HCFA offered the exhibit so untimely.

I am satisfied that Petitioner will not be prejudiced by my receiving the exhibit into evidence. I provided Petitioner with ample protection to assure that it would not be prejudiced by my receipt into evidence of HCFA Ex. 39. I ordered HCFA, despite its strenuous objections, to produce communications between its counsel and Mr. Hartzell which Petitioner might use to question the credibility of the exhibit. I gave Petitioner the opportunity to subpoena Mr. Hartzell and to cross-examine him concerning the creation of HCFA Ex. 39. In connection with that offer, I offered to reopen the record to receive Mr. Hartzell's testimony, the testimony of other witnesses, or any exhibits that Petitioner might offer which it could use to rebut HCFA Ex. 39 or to impeach Mr. Hartzell's testimony.

Petitioner argues that the probative value of HCFA Ex. 39 is diminished by virtue of the fact that it is a hearsay statement by Mr. Hartzell. I am not persuaded that the exhibit's probative value is diminished because the exhibit contains hearsay. The exhibit is an official interpretation of California law by an entity that is vested with the authority to publish such an interpretation. The fact that the exhibit contains hearsay because the statements in the exhibit are in the form of a written opinion and were not uttered by a declarant on the record of the hearing does not make them less than authoritative any more than would be the case with any official text or public document.

III. ISSUE, FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. Issue

The issue in this case is whether, as of March 20, 1996, Petitioner was not complying substantially with one or more federal participation requirements.

There are other potential issues in this case which Petitioner has not elected to litigate. Petitioner does not contend that the amount of the civil money penalty which HCFA elected to impose against it, $100 per day beginning with March 20, 1996, is unreasonable if HCFA is authorized to impose a remedy against Petitioner. Tr. at 7. Nor does Petitioner assert that the duration of the remedies in this case - from March 20, 1996 until April 9, 1996 - is incorrect, assuming that HCFA had a basis to impose remedies against Petitioner beginning on March 20, 1996. Id. at 32 - 33.

This case involves an additional issue which was decided previously and which I will not address in this decision. That is the issue of whether HCFA gave Petitioner sufficient notice of its intent to impose remedies against Petitioner effective March 20, 1996. That issue was decided by the appellate panel's Desert Hospital decision.

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. As of March 20, 1996, Petitioner employed a physical therapist assistant. The physical therapist assistant made initial assessments and revised assessments of residents' needs for physical therapy services. Additionally, the physical therapist assistant obtained and executed verbal orders for treatment of residents directly from residents' physicians.

It does not appear that there is any dispute about the relevant facts of this case. Indeed, Petitioner did not elect to challenge the facts as found by the California State survey agency surveyors at the March 20, 1996 survey of Petitioner. See Petitioner's posthearing brief at 1 - 5; HCFA Ex. 1.

The evidence establishes that, as of March 20, 1996, Petitioner employed a licensed physical therapist and a physical therapist assistant. See Tr. at 336 - 337, 339 - 340. The physical therapist assistant worked under the general supervision of the physical therapist. The physical therapist was present at least 50 percent of the time that the physical therapist assistant was present and performing his duties. Id. at 336.

The physical therapist assistant was a skilled practitioner who had an excellent reputation in the local medical community for his ability to treat wounds. Tr. at 341 - 343. His experience included doing sharp debridement of wounds. Id. "Sharp debridement" means removing dead tissue from a wound with an instrument such as scissors or a scalpel. HCFA Ex. 25 at 1. Physicians sometimes referred patients directly to Petitioner's wound care center so that the patients could be treated by the physical therapist assistant. Id. at 344.

At times, the physical therapist assistant functioned more as an aide to residents' treating physicians than as a subordinate employee of the physical therapist. The physical therapist assistant provided services under the direct verbal instructions of physicians. For example, in an instance involving a resident identified in the survey report as Resident # 12, the physical therapist assistant obtained a telephone order directly from the resident's physician to discontinue the treatment that had been prescribed for the resident and to substitute a different course of treatment for that resident. HCFA Ex. 1 at 9; HCFA Ex. 16 at 11. The supervising physical therapist was bypassed by the physical therapist assistant and the resident's physician in the instance where the physical therapist assistant dealt directly with a resident's treating physician.

This bypassing of the supervising physical therapist is demonstrated also by the care that the physical therapist assistant gave to a resident identified in the survey report as Resident # 9 (the report of the resurvey incorrectly refers to Resident # 9 at one point as "Resident # 1;" see HCFA Ex. 1 at 8 - 9). HCFA Ex. 1 at 8 - 12. Here, the physical therapist assistant decided, either on his own volition, or in an unrecorded consultation with the resident's treating physician, to provide care to the resident that was not ordered in writing and which was not approved by the supervising physical therapist. The physical therapist assistant performed a sharp debridement of Resident # 9's wound. HCFA Ex. 15 at 6. That care was contrary to the treating physician's written order. The written order given by the physician did not specify a sharp debridement. Rather, it stated that the physical therapy staff was to use "whirlpool" treatment "to debride" the resident's wound. HCFA Ex. 15 at 3. The resident's treatment records show no consultation with or supervision by the supervising physical therapist. No assessment was done of the resident by the supervising physical therapist. See HCFA Ex. 15.

The physical therapist assistant revised residents' treatment plans based on his direct communications with physicians. In providing care to Resident # 12, the physical therapist assistant did an interim assessment of the resident which resulted in a change of the treatment that was being provided to the resident. The physical therapist assistant performed the interim assessment and adjusted the resident's treatment without the advance approval and review of the supervising physical therapist. HCFA Ex. 1 at 10; HCFA Ex. 16 at 5.

2. The physical therapist assistant did not perform his duties consistent with the requirements of California State law.

At the heart of this case is the question of whether the version of California State law that was in effect on March 20, 1996 allowed a physical therapist assistant to interact directly with a physician or plan a patient's care. HCFA asserts that California State law prohibited a physical therapist assistant from engaging in those activities. According to HCFA, under California State law such activities were the sole responsibility of a physical therapist and could not be delegated to a physical therapist assistant. Petitioner argues that the law permitted a physical therapist to delegate his or her duties to a physical therapist assistant. Petitioner contends that the activities of the physical therapist assistant which I describe above, at Finding 1, were performed within the requirements of California State law because they were performed under the general supervision of, and delegation of authority by, the supervising physical therapist.

HCFA's specific allegations of noncompliance are as follows:

• California State law does not permit a physical therapist assistant to receive and execute verbal orders from a physician. The physical therapist assistant employed by Petitioner failed to comply with this requirement when he received and executed a telephone order to provide care to Resident # 12. HCFA Ex. 1 at 9.

• California State law does not permit a physical therapist assistant to perform initial and interim assessments of residents for the purpose of deciding appropriate treatment to be provided to those residents. The physical therapist assistant employed by Petitioner failed to comply with this requirement when he made assessments of Resident #s 9 and 12 and provided care to those residents based on his assessments without the direct supervision of the supervising physical therapist. HCFA Ex. 1 at 9 - 10.

I conclude that, as of March 20, 1996, California State law prohibited a physical therapist assistant from interacting directly with a physician or planning a patient's care. Under California State law, a supervising physical therapist may not delegate to a physical therapist assistant the authority: to deal directly with a physician; to make assessments; or to write or revise patient treatment plans. The physical therapist assistant that Petitioner employed contravened the requirements of California State law: when he received verbal orders directly from residents' physicians and when he performed assessments of residents' conditions and planned and implemented their care.

a. As of March 20, 1996, California State law prohibited a physical therapist assistant from receiving and executing orders directly from a physician. Additionally, as of March 20, 1996, California State law prohibited a physical therapist assistant from planning the care to be given to a patient.

Both the terms "physical therapist" and "physical therapist assistant" are defined under California State law. Section 2655 of the California Business and Professions Code defines these terms as follows:

(a) "Physical therapist" means a physical therapist licensed by the . . . [Physical Therapy Board of California].

(b) "Physical therapist assistant" means a person who . . . is approved by the . . . [Physical Therapy Board of California] to assist in the provision of physical therapy under the supervision of a physical therapist who shall be responsible for the extent, kind, and quality of the services provided by the physical therapist assistant.

Cal. Business & Professions Code § 2655(a), (b) (West 1990); HCFA Ex. 10; see HCFA Ex. 39.

The California State statute does not describe the nature and extent of supervision that a physical therapist assistant must receive from a physical therapist. The Physical Therapy Board of California has published regulations which describe the supervisory responsibilities of a physical therapist over a physical therapist assistant. California Code of Regulations, Title 16, Division 13.2, Section 1398.44. As of March 1996, when the resurvey of Petitioner was conducted, the regulation provided as follows:

§ 1398.44. Adequate Supervision Defined

A supervisor shall at all times be responsible for and provide adequate supervision of the work performed by the assistant. Adequate supervision shall include all of the following:

(a) The supervisor shall be present in the same physical therapy facility with the assistant at least fifty percent of any work week or portion thereof the assistant is on duty . . . The supervisor shall be readily available to the assistant at all other times for advice, assistance, and instruction.

(b) The supervisor shall initially evaluate each patient prior to providing of physical therapy treatment by the assistant.

(c) The supervisor shall plan each patient's treatment program and determine which elements thereof can be delegated to the assistant.

(d) The supervisor shall provide periodic reevaluation of the treatment program and of the assistant's performance in relation to the patient.

(e) The supervisor shall perform and record an evaluation of the patient and his or her response to treatment at the termination thereof.

HCFA Ex. 11; see HCFA's posthearing brief at 15 - 16. Although the regulation does not specify that the term "supervisor" means "physical therapist" or that the term "assistant" means "physical therapist assistant" these meanings are apparent from the text of the regulation.

I asked the parties to supply me with judicial decisions, interpretations, or policy statements which explained how the California State statute and regulation would govern the performance of duties by a physical therapist assistant. The parties acknowledge that there appear to be no judicial decisions which are on point. At the in-person hearing, HCFA attempted to offer the testimony of Ms. Daufen as expert opinion as to the meaning of the March 1996 version of the regulation. I held there, and I reiterate here, that Ms. Daufen is not qualified to provide such expertise. CSM Home Health Services, Inc., DAB No. 1622, at 12 - 14 (1997). Ms. Daufen is an employee of the California State survey agency. She is not employed by the Physical Therapy Board of California. She has not been vested with any authority by the State of California to interpret statutes or regulations on behalf of the State.

HCFA has supplied me with the interpretation contained in HCFA Ex. 39. The interpretation makes it absolutely clear that a physical therapist assistant could not interact directly with a physician or perform assessments of patients' conditions under the post-March 1996 version of the applicable regulation. However, the interpretation does not address the meaning of the regulation that was in effect as of March 20, 1996. I find the interpretation of the regulation contained in HCFA Ex. 39 to be of little value in deciding what the March 1996 version of the regulation meant. The regulation was amended and revised substantially after March 1996. See Petitioner's posthearing brief, Exhibit C. The definition of "adequate supervision" that is contained in the post-March 1996 version of the regulation differs in significant respects from that which was contained in the version that was in effect as of March 20, 1996. See Id.

That is not to suggest that the interpretation contained in HCFA Ex. 39 is of no benefit to deciding what supervision requirements pertained as of March 1996. I find the interpretation in HCFA Ex. 39 to be a persuasive interpretation of the meaning of Section 2655 of the California Business and Professions Code. With respect to the statute, HCFA Ex. 39 provides that:

California law does not authorize any other classification of health care provider to supervise a physical therapist assistant. Consequently, a physical therapist assistant may NOT be supervised by a physician and surgeon or registered nurse.

HCFA Ex. 39 at 2 (capitalization and emphasis in original). This interpretation makes it plain that, under the California State statute, a physician may not interact directly with a physical therapist assistant to provide instructions to the physical therapist assistant.

A close reading of the regulation governing supervision of physical therapist assistants that was in effect as of March 20, 1996 leads me to conclude that it prohibited a physical therapist from delegating to a physical therapist assistant the tasks of performing initial patient evaluations, planning patients' care, and performing patient reevaluations. The regulation specifically reserved to the supervising physical therapist the duties of: initially evaluating each patient prior to providing physical therapy to that patient; planning each patient's treatment program; and, periodically reevaluating each patient's treatment program. HCFA Ex. 11.

The regulation makes it plain that only limited tasks may be delegated by a physical therapist to a physical therapist assistant. These tasks consist of the treatments that a physical therapist may provide to a patient. HCFA Ex. 11.

There is one official interpretation of the regulation which is of record in this case and which discusses the duties that may be delegated by a physical therapist to a physical therapist assistant. That is the interpretation that is contained in HCFA Ex. 25. The interpretation is an interpretation dated September 26, 1995, in which the California Physical Therapy Examining Committee addresses the questions of whether a physical therapist may perform a sharp debridement and whether a physical therapist may delegate to a physical therapist assistant the task of performing a sharp debridement. The interpretation concludes that a physical therapist may perform a sharp debridement. HCFA Ex. 25 at 1 - 2. In discussing the question of whether this task may be delegated by a physical therapist to a physical therapist assistant, the interpretation makes the following statement about delegation of the duties of a physical therapist:

[t]hus, the general purpose of the statutes authorizing the approval and utilization of physical therapist assistants appears to be to allow the licensed therapist to use the assistant in all aspects of physical therapy practice with the condition that the assistant be appropriately supervised when providing such assistance.

As it has been determined that a physical therapist assistant may assist the licensed therapist in any physical therapy services without limitation, subject to adequate supervision by the licensed physical therapist, the physical therapist assistant in accordance with the Physical Therapy Practice Act and the Physical Therapy Regulations may, with appropriate training, perform debridement.

HCFA Ex. 25 at 3.

I do not find that this interpretation authorizes physical therapist assistants to communicate directly with physicians or to engage in assessment and care planning of patients. Although the interpretation is broadly worded, it is written in the context of whether a particular task (debridement) may be delegated by a physical therapist to a physical therapist assistant. It does not speak to the broader questions of whether communications with a physician and care planning may be delegated. I find the interpretation to be consistent with the distinction that is apparent in the California State regulations which govern physical therapy between tasks, which may be delegated, and planning, which may not be delegated.

Petitioner argues that it satisfied the requirements of the regulation that the supervising physical therapist be on the premises of Petitioner's facility at least fifty percent of the time. It asserts that the activities that were performed by the physical therapist assistant were lawful in that they were supervised generally by the physical therapist.

I am not persuaded by this argument. The tasks that are at issue here may not be delegated to a physical therapist assistant even if the supervising physical therapist complies with general supervision requirements.

I would be inclined to agree with Petitioner were the issue in this case whether the physical therapy assistant had been supervised properly in the performance of duties that could lawfully be delegated to him. Thus, I would be inclined to rule in Petitioner's favor had the determining question in this case been whether the physical therapist assistant had been supervised properly in performing wound debridements. But, that is not the question to be decided here. Here, the question is whether the physical therapist assistant performed tasks that could not be delegated lawfully to him. Communicating with a physician, planning care, and assessing patients are tasks that may not be delegated. The presence or absence of the supervising physical therapist from the facility is irrelevant to deciding the question of whether the physical therapist assistant performed tasks that could not lawfully be delegated to him.

b. The physical therapist assistant failed to comply with the requirements of California State law when he communicated directly with residents' physicians and performed assessments of residents' conditions.

As of March 20, 1996, the physical therapist assistant in Petitioner's employ was performing tasks that he could not perform lawfully under California State law. The physical therapist assistant was communicating directly with residents' physicians. Such communications are not lawful under the California State statute which governs physical therapy. The physical therapist assistant was assessing residents and planning their care in contravention of regulations which specifically require such tasks to be performed by a physical therapist and which prohibit delegation of such tasks to a physical therapist assistant.

3. Petitioner failed to comply substantially with the participation requirement that the surveyors cited at Tag 281 of the report of the resurvey of Petitioner that was completed on March 20, 1996.

At Tag 281 of the report of the resurvey of Petitioner, the surveyors asserted that Petitioner had failed to comply substantially with the requirements of 42 C.F.R. § 483.20(d)(3)(i). HCFA Ex. 1 at 6 - 11. The applicable regulation requires a long-term care facility to provide or arrange services to its residents that meet professional standards of quality.

The surveyors premised their assertions of noncompliance on Petitioner's alleged failure to comply with "current standards of practice in California." HCFA Ex. 1 at 8. Implicit in their logic is their conclusion that failure by a long-term care facility to comply with a current standard of practice constitutes a failure by that facility to provide or arrange services that meet professional standards of quality.

The surveyors alleged that the following were applicable standards of practice governing the performance of physical therapy:

1. The initial and subsequent assessment and treatment plans [for physical therapy] are to be accomplished by the Registered Physical Therapist.

2. Only a Registered Physical Therapist can take verbal or telephone orders, since all changes in the [physical therapy] treatment plan . . . [are] the responsibility of the Registered Physical Therapist.

3. The Registered Physical Therapist is responsible for assigning specific tasks within the treatment plan to the Physical Therapy Assistant consistent with . . . [his or her] training and experience.

4. The Registered Physical Therapist is responsible for direct supervision of the Physical Therapy Assistant for 50 percent of the time.

HCFA Ex. 1 at 8.

These alleged standards of practice comport with the surveyors' conception of what was mandated by California State law as of March 20, 1996. The surveyors' and HCFA's logic is that California State law codifies standards of practice that govern the provision of physical therapy in California.

It is reasonable to describe statute- or regulation-mandated standards as constituting "standards of practice" that are applicable to a profession in a particular jurisdiction. I therefore agree with the surveyors' and HCFA's assertion that standards that are mandated under the law of a particular State may constitute statewide "standards of practice."

Further, I agree that the first three standards that the surveyors asserted to govern the practice of physical therapy in California comprised applicable standards of practice as of March 20, 1996. These standards comport with what was required by law. However, I do not agree with the surveyors' characterization of the fourth alleged standard of practice. California State law did not, as of March 20, 1996, require a registered physical therapist to supervise directly a physical therapist assistant for fifty percent of the time that the physical therapist assistant performed his or her job duties. The applicable regulation provided only that the supervising physical therapist "be present in the same physical therapy facility with the assistant at least fifty percent of any work week or portion thereof the assistant is on duty." HCFA Ex. 11. The requirement is merely that the supervisor be on the same premises as the physical therapy assistant at least fifty percent of the time. That is a requirement of indirect, and not direct, supervision.

I find that the standards of practice which the surveyors identified, and which I find to be embodied in California State law as of March 20, 1996, constitute acceptable standards of quality within the meaning of 42 C.F.R. § 483.20(d)(3)(i). A reasonable reading of the regulation is that it is intended to incorporate standards of quality that have general application to long-term care facilities. State-mandated practice standards plainly are standards of quality of general application.

The evidence establishes that Petitioner was not complying with the requirements of 42 C.F.R. § 483.20(d)(3)(i) as of March 20, 1996. As I find above, at Finding 2, the physical therapy assistant who was employed by Petitioner contravened the requirements of State law. He did so by performing tasks that could only be performed by a physical therapist and which could not be delegated to a physical therapist assistant. The physical therapist assistant communicated directly with residents' treating physicians. The physical therapist assistant planned residents' care and altered residents' treatment plans.

The failure by Petitioner to comply with the requirements of 42 C.F.R. § 483.20(d)(3)(i) was substantial. There is no evidence that the physical therapist assistant or Petitioner committed any act or omission that actually harmed residents. Indeed, it is apparent that physicians dealt directly with the physical therapist assistant because they had high regard for his skill and expertise. But, notwithstanding, the failure by the physical therapist assistant and Petitioner to comply with requirements of State law posed the potential for more than minimal harm to residents. The legislative conclusion which underlies California State law is that, by definition, a physical therapist assistant is not qualified to exercise discretion and judgment to perform certain tasks that are specifically assigned to a physical therapist. The legislative conclusion also is that a physical therapist assistant is not qualified to receive an order directly from a physician or to plan a patient's care. Implicit in these conclusions is a finding that there exists a potential for harm where a physical therapist assistant oversteps the limits of what the State of California has decided he or she may do.

4. Petitioner failed to comply substantially with the participation requirement that the surveyors cited at Tag 407 of the report of the resurvey of Petitioner that was completed on March 20, 1996.

At Tag 407 of the report of the resurvey of Petitioner, the surveyors asserted that Petitioner had failed to comply substantially with the requirements of 42 C.F.R. § 483.45(b). HCFA Ex. 1 at 11 - 13. This regulation requires that, where a long-term care facility provides specialized rehabilitative services, those services must be provided by qualified personnel pursuant to the written order of a physician. The surveyors concluded that Petitioner had provided rehabilitative services to a resident without a physician's written order.

The evidence which the surveyors relied on to support their conclusion pertains to the care that was provided by the physical therapist assistant to Resident # 9. I have discussed that care above, at Finding 1. I reiterate here that the evidence establishes that the physical therapist assistant performed a sharp debridement of the resident's wound without a written order that he perform a sharp debridement. The treatment order that the physician issued for Resident # 9 specifies that Petitioner's staff was to use a "whirlpool to debride" the resident's wound. HCFA Ex. 1 at 11; HCFA Ex. 15 at 3.

The weight of the evidence supports the surveyors' allegations about the care that was given to Resident # 9. The evidence shows that, in treating Resident # 9, the physical therapist assistant provided a treatment that had not been ordered in writing by the resident's physician. An order to use a whirlpool to debride a wound is not functionally equivalent to an order that a sharp debridement be performed. The former treatment involves the use of water to remove dead tissue. HCFA Ex. 1 at 11. The latter involves the use of sharp instruments to remove dead tissue. Id.

Petitioner argues that the order for "whirlpool to debride" may be read reasonably as an order to: (1) provide a whirlpool treatment to Resident # 9 and (2) perform a sharp debridement of the resident's wound. I do not find this to be a reasonable reading of the order. On its face, it plainly directs Petitioner's staff to use a whirlpool treatment as a means of debriding the resident's wound. It does not suggest that an additional treatment (sharp debridement) should be used to debride the resident's wound. Furthermore, even if there was some arguable ambiguity in the order that ambiguity should have been clarified with additional written instructions before treatments were provided to the resident.

The failure of Petitioner to assure that there was a written order by a physician to perform a sharp debridement of Resident # 9's wound is a failure to comply with the requirements of 42 C.F.R. § 483.45(b). The regulation plainly requires a written physician's order to authorize the performance of specialized care. Petitioner failed to obtain such an order to authorize the sharp debridement of Resident # 9's wound.

Petitioner's failure to comply with the requirements of 42 C.F.R. § 483.45(b) is substantial. I do not find that Petitioner's failure to obtain a written order for sharp debridement of the resident's wound actually harmed the resident. It is possible that sharp debridement may have been a clinically appropriate treatment in this instance. But, I find that the deficiency posed a potential for more than minimal harm.

The requirement in 42 C.F.R. § 483.45(b) that there be a written physician's order for a specialized rehabilitative service is, on its face, a conclusion that such services must be provided only with the close involvement of a physician. Implicit in that conclusion is a finding by the Secretary that providing such services to a resident without a physician's written order might be harmful to the resident.

In deciding that the failure by Petitioner to comply with the requirements of 42 C.F.R. § 483.45(b) is substantial, I have considered the question of whether the one instance of noncompliance cited in the report of the resurvey of Petitioner represents merely an isolated error rather than some systemic problem in the way that Petitioner provided care. On other occasions I have held that a conclusion that a facility is deficient may not necessarily result from proof that the facility has committed a single error in providing care. Here, however, the evidence establishes that the failure to obtain a written order from a physician to perform a sharp debridement was not an isolated mistake. Rather, it established a repeated failure by Petitioner to assure that there were written orders from physicians for specialized and rehabilitative services. At the February 1996 survey of Petitioner, the surveyors had found that the physical therapist assistant was providing services without the written orders of physicians. HCFA Ex. 1 at 14 - 15.

5. Petitioner failed to comply substantially with the participation requirement that the surveyors cited at Tag 501 of the report of the resurvey of Petitioner that was completed on March 20, 1996.

At Tag 501 of the report of the resurvey of Petitioner, the surveyors asserted that Petitioner had failed to comply substantially with the requirements of 42 C.F.R. § 483.75(i). HCFA Ex. 1 at 13 - 15. The cited regulation requires, at 42 C.F.R. § 483.75(i)(2)(i), that a long-term care facility's medical director be responsible for implementing resident care policies. The surveyors alleged that Petitioner was deficient in complying with this requirement in that its medical director had failed repeatedly to implement policies which governed physical therapy services. Id. at 13.

This allegation is substantiated by the weight of the evidence. The uncontradicted evidence is that Petitioner had been cited repeatedly for failure to comply with professional standards of quality in the provision of physical therapy services and for failure to assure that the physical therapy services it provided had been ordered in writing by a physician. HCFA Ex. 1 at 13 - 15. The deficiencies that the surveyors identified as of March 20, 1996 were deficiencies that Petitioner had been apprised of on previous occasions. Petitioner's medical director had failed to discharge his responsibilities by assuring that these deficiencies were not repeated.

6. HCFA established a basis to impose remedies against Petitioner.

A basis exists for HCFA to impose remedies against Petitioner. Those remedies may include denial of payment for new admissions. As I discuss above, at Part I.B. of this decision, HCFA is authorized to impose a remedy or remedies against a long-term care facility where it is shown that the facility is not complying substantially with one or more federal participation requirements. Here, the weight of the evidence establishes that, as of March 20, 1996, Petitioner was not complying substantially with one or more participation requirements.

Steven T. Kessel
Administrative Law Judge