Kirkland, held a formal hearing in this case on May 4, 2000, by video teleconference in Tallahassee and Miami, Florida.
For Petitioner: No appearance.
For Respondent: Michelle L. Oxman, Esquire
Whether osteochondral autograft transplant surgery should be authorized for Petitioner pursuant to Workers' Compensation Law.
By letter dated September 15, 1999, Respondent, Agency for Health Care Administration (Agency), advised Petitioner, Virginia Jackson (Jackson), and others that the proposed procedure, osteochnondral autograft transplant surgery (OATS), was not approved for coverage under the Workers' Compensation Law because the procedure was investigational in nature and did not provide additional benefit to Jackson. On September 27, 1999, Jackson filed a request for an administrative hearing with AHCA, and the case was forwarded to the Division of Administrative Hearings on October 26, 1999, for assignment to an Administrative Law Judge.
The final hearing was originally scheduled for February 8, 2000. On February 2, 2000, Respondent filed a Motion for Continuance, which was granted. The final hearing was rescheduled for May 4, 2000.
On April 12, 2000, Counsel for Petitioner filed a Motion to Withdraw. The motion was granted.
At the final hearing Petitioner did not appear and did not advise the Division of Administrative Hearings why she did not appear. Respondent presented the testimony of Dr. B. Hudson Berrey by deposition. There was no transcript of the hearing.
On May 24, 2000, Respondent filed its Proposed Recommended Order, which has been considered in rendering this Recommended Order.
In 1998, Jackson fell at work and sustained an injury to her left knee. Jackson made a workers' compensation claim for the treatment of the injuries. She underwent treatment for her injuries, and her treating physician requested authorization from Jackson's Employer/Carrier to perform a surgical procedure commonly referred to by the trade name of OATS, but also known as mosaicplasty.
The Employer/Carrier denied the authorization on the ground that OATS was investigative or experimental within the meaning of Rule 59B-11.002, Florida Administrative Code, and referred the request to the Agency for a determination under Section 440.13(1)(m), Florida Statutes, and Rule 59B-11.002(4), Florida Administrative Code.
The Agency requested Dr. B. Hudson Berrey, the Chair of the Department of Orthopedics and Rehabilitation at Shands Hospital and Clinic at the University of Florida, to review Jackson's case to determine whether the procedure was investigative and whether the procedure would provide significant benefits to the recovery and well-being of Jackson.
Dr. Berrey has been board certified in orthopedic surgery since 1982. After three years of practice, he took a fellowship in orthopedic oncology at Massachusetts General Hospital in Boston, Massachusetts. He then served as Chief of Orthopedic Oncology and, later, as Chief of Orthopedic Surgery at Walter Reed Army Medical Center in Washington, D. C. After his retirement in 1993, he served on the faculty of the University of Texas Southwestern Medical Center. He has been the Chair of the Department of Orthopedics and Rehabilitation at the University of Florida College of Medicine since 1996.
In addition to his teaching duties, he continues to see patients weekly and to perform orthopedic surgery twice a week. His duties require him to keep abreast of developments in the field of orthopedic surgery.
In preparation for rendering his opinion for the Agency, Dr. Berrey reviewed the medical literature, seeking articles discussing clinical trials of OATS. A clinical trial is an investigation in which patients with a certain condition may receive a treatment under study if they meet certain objective standards for inclusion. The treatment parameters are defined and outcomes are assessed according to objective criteria.
Dr. Berrey found very little in peer-reviewed literature discussing clinical trials of OATS or mosiacplasty.
Instead he found retrospective reviews and case reports. Based on his review of the medical literature, Dr. Berrey formed the opinion that mosaicplasty may be safe and efficacious; however, because the procedure has not been subjected to clinical trials, the procedure remains investigative.
OATS involves the transfer of a patient's cartilage from one portion of the knee that is not considered weight- bearing or that is considered as having a minimal weight-bearing load to an area that receives greater force or is more weight- bearing. Dr. Berrey is of the opinion that OATS may be effective to treat isolated chondral defects on the weight- bearing surface of the knee. He describes the type of injury for which the procedure is effective as a focal lesion in an otherwise normal knee.
Three components comprise the knee: the patella, the femoral articulating surface, or femoral condyle, and the tibial articulating surface or tibial plateau. The femoral condyle and tibial plateau are bony structures lined with articular cartilage that provide the gliding surface of the knee. The patella articulates with the femur at the patellar femoral joint, and the tibia articulates with the femur at the tibial femoral joint. The tibial femoral joint is made up of medial and lateral components. Other structures present in and about
the knee include the menisici, the cruciate ligaments, and the collateral ligaments.
Jackson's medical records, including the MRI report, show that there is a subchondral cyst and/or osteochondral defect on the anterior articular margin of the mid-media femoral condyle. There are subchondral cysts along the posterior portion of the mid-tibial plateau. In addition, there is a prominent osteochondral defect involving the patella. Jackson has articular damage to all three compartments of the knee: the femoral condyle, the patella, and the tibial plateau.
Based on the degenerative changes in all three compartments of the knee, Jackson's changes are probably generalized. She does not have a focal defect of the articular cartilage of the knee. Her symptoms relate primarily to the patellar femoral joint. Her medical records describe her injuries as including chondromalacia of the patella. The term "chondromalacia" applies to a continuum of deterioration of the articular cartilage of the patella, from softening to frank fraying to fibrillation where the cartilage may be worn down to the bare bone.
OATS or mosiacplasty is designed to address a localized, focal lesion. Because of the generalized nature of the diseased condition of Jackson's knee and the probability that her symptoms are related to the deterioration of her
patellar femoral joint, the proposed procedure is not likely to improve her condition or to enable her to return to work.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to and the subject matter of these proceedings. Section 120.57(1), Florida Statutes.
Pursuant to Section 440.13(1)(m), Florida Statutes, the Agency is charged with the responsibility to review proposed treatments claimed to be experimental or investigative and to determine, based upon standards developed by the Agency, whether those treatments should be made available to the injured employees in workers' compensation cases.
Rule 59B-11.001, Florida Administrative Code, provides:
Section 440.13(2), Florida Statutes, requires employers to provide their injured employees such medically necessary treatment, care, and attendance as is required for the nature of their injury or process of recovery. "Medically necessary," as defined at section 440.13(1)(m), Florida Statutes, excludes all experimental, investigatory or research-related medical procedures and supplies unless they are appropriate to the injured employee's diagnosis and have been shown to have significant benefits to the recovery and well-being of the injured employee. Prior approval from the Agency for Health Care Administration must be obtained for an experimental, investigatory or research- related procedure or supply to be covered and compensable. When approached for a
review by an employee, employer or carrier, the agency shall determine whether the procedure or supply is experimental, investigatory or of a research nature and then approve or disapprove the proposed procedure or medical supply on a case by case basis.
Rule 59B-11.002(5), Florida Administrative Code, defines the term "investigative" as follows:
Investigative describes a medical service, procedure, drug, equipment or supply which has been found safe and efficacious for the particular diagnosis but is still being investigated. The reliability, validity, efficacy and cost benefit of the service, procedure, drug, equipment or supply has not been conclusively demonstrated for use in treating or diagnosing the injury or illness being covered under workers' compensation medical benefits. This can but need not include treatments and procedures being tested in phase III clinical trials.
The OATS or mosaicplasty procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. It has been found safe and efficacious for the diagnosis of focal defects of the femoral condyle, but its reliability, validity, efficacy, and cost benefit have not yet been conclusively demonstrated.
Rule 59B-11.004, Florida Administative Code, provides:
The agency shall not approve any treatment which is experimental or one that is being proposed as an integral part of a research project. A treatment that is classified as investigational may be approved if reliable evidence suggests that it will provide significant benefits toward
the recovery and well being of the injured employee.
In determining whether a proposed medical procedure or supply will provide significant benefits toward the recovery and well being of the injured employee, the agency shall consider the cost and benefits of the proposed procedure or supply with regard to injured employee's condition, case history, other similar case histories, and available alternative treatments.
In making the determination for an approval, there must be reliable evidence indicating:
that the proposed procedure or supply is safe and efficacious in relation to existing diagnostic or therapeutic alternatives,
that the proposed procedure or supply will yield positive net beneficial effects on health outcomes that outweigh any harmful effects in relation to existing diagnostic or therapeutic alternatives, and
that the positive net beneficial effects of the proposed procedure or supply outweigh the cost.
Reviewers shall place substantial weight on results of clinical trials that have been performed. However, it is recognized that some widely-accepted, non- experimental medical treatments and procedures have not been subjected to the stringent phases of clinical trials. Thus, when the injured employee's condition is rare or terminal if left untreated, or when alternate treatments have not been effective or have not been effective in similar cases, and clinical trials have not clearly demonstrated efficacy of the proposed treatment, reviewers may still recommend approval of the proposed treatment for coverage.
Rule 59B-11.002(7), Florida Administrative Code, defines "reliable evidence" as follows:
"Reliable evidence" means practice parameters or guidelines endorsed by AHCA pursuant to sections 440.13(15), or 408.02, Florida Statutes, or sources of information where medical researchers have expressed their conclusions in a scientifically appropriate manner including peer-reviewed literature and articles published in medical and scientific journals.
Rule 59B-11.002(8), Florida Administrative Code, provides:
"Significant benefits to the recovery and well being of the injured employee" means that evidence indicates that the proposed procedure or supply is more likely than not, when compared with other treatment modalities, to promote the injured employee's ability to return to gainful employment by maintaining or improving his or her functional condition. . . .
There was no reliable evidence that the proposed surgery was likely to provide significant benefits to the recovery and well being of Jackson within the meaning of Rule 59B-11.004(7) and (8), Florida Administrative Code. OATS or mosaicplasty has not been demonstrated to be safe or efficacious for Jackson's injuries.
The proposed procedure is not medically necessary for Jackson's injuries, and authorization for the procedure should be denied.
