) Case No. 00-3662
vs. )
Respondent. )
A formal hearing was held in this case on February 1, 2001, in Miami, Florida, before Florence Snyder Rivas, a designated Administrative Law Judge of the Division of Administrative
Hearings.
For Petitioner: Barry A. Pemsler, Esquire
For Respondent: Michelle L. Oxman, Esquire
Whether Petitioner's request for authorization for the autologous chondrocyte implantation (ACI) procedure should be approved pursuant to worker's compensation laws and rules.
By letter dated July 13, 2000, the Agency for Health Care Administration (AHCA) notified Petitioner, Carl Witherspoon (Witherspoon), that the proposed ACI procedure was deemed investigational in nature and not approved for coverage under Worker's Compensation in light of his diagnosis and condition. Witherspoon timely disputed Respondent's determination. This matter was thereafter referred to the Division of Administrative Hearings (DOAH) for a formal hearing.
At hearing, Witherspoon testified in his own behalf and presented the deposition testimony of Dr. Douglas Stringham. Witherspoon requested and was granted leave to late-file the deposition testimony of Dr. Wayne K. Gersoff. AHCA submitted the deposition testimony of Dr. Peter Indelicato, and requested official recognition of DOAH Case No. 00-0775, Rebecca Crane vs. Agency for Health Care Administration, and DOAH Case No.
A one-volume transcript of the hearing was filed with DOAH on April 2, 2001. Timely proposed recommended orders were filed on April 9, 2001, and have been carefully considered in the preparation of this Recommended Order.
Witherspoon is a 41-year-old police officer. He has worked in law enforcement for 20 years and is currently employed as a police officer for the City of Fort Lauderdale.
Witherspoon was injured in an employment-related accident on September 14, 1999. The accident significantly aggravated a pre-existing injury to his left knee.
At the time of the accident, Witherspoon had already had two arthroscopic surgical procedures to treat his pre- existing knee injury. He underwent a third arthroscopic surgery following the accident, and returned to work in the Spring of 2000.
In addition to surgery and physical therapy, Witherspoon has been treated continuously with injections and medications in an effort to alleviate his symptoms, to no avail.
At all times relevant to this case, Witherspoon has two separate injuries to the articular cartilage of his knee: one in the trochlea and one in the medial femoral condyle.
Because of these injuries, Witherspoon's articular cartilage, which is necessary for proper functioning of the knee joint, has been degrading and flaking off and will continue to do so. The injuries cause him to walk with a significant limp. He is in constant pain and constant danger of his knee buckling.
Witherspoon's situation is complicated by a defect in the articular cartilage of his patella. ACI was not recommended for this defect, and it is unknown how debilitating the patella injury would continue to be, if and when ACI treatment is successfully completed.
Because of his injuries, Witherspoon is unable to perform the duties of a uniformed police officer. He is presently assigned to desk work, at a significantly reduced salary.
Witherspoon is on an accelerated course to advanced degenerative arthritis, for which a complete knee replacement is the standard recommended treatment. Because Witherspoon is relatively young and knee replacements do not last indefinitely, the unanimous weight of medical opinion is that knee replacement should be postponed as long as possible.
Witherspoon's treating physician, having exhausted all viable treatment options, referred Witherspoon to Dr. Douglas Stringham (Stringham), a Board-certified orthopedic surgeon.
After reviewing Witherspoon's arthroscopic photographs and medical records, Stringham recommended that he undergo ACI.
Witherspoon requested authorization for the ACI procedure, which was denied by his Employer/Carrier City of Fort Lauderdale (Employer). The dispute was referred to AHCA for
review in accordance with Subsection 440.13(1)(m), Florida Statutes.
AHCA consulted with Dr. Peter Indelicato (Indelicato), a Board-certified orthopedic surgeon. Indelicato rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code.
He further opined that there was not reliable evidence that ACI would provide significant benefit to Witherspoon's recovery and well being within the meaning of Rule 59B- 11.004(3), Florida Administrative Code.
Relying exclusively upon Indelicato’s opinion, AHCA declined to order the Employer to provide ACI to the Petitioner.
Upon the filing of this petition, Witherspoon was advised by the Employer that neither ACI nor any other form of intervention would be offered to him.
AHCA has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Subsection 440.13, Florida Statutes.
The ACI procedure which has been recommended to Witherspoon was initially developed in Sweden. Over the course of two separate surgical procedures, a sample of cartilage is first harvested arthroscopically from another area of the patient's knee joint.
The sample is sent to the Boston Laboratory of Genzyme Tissue Repair, Inc. (“Genzyme”), which owns the rights to the process. Genzyme uses its proprietary process to culture the cells into an estimated five million chondrocytes over a period of approximately five weeks.
Genzyme returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted in the wounded cartilage and covered with the periosteal flap.
The claimed benefit of ACI is that the cartilage that is generated and implanted into the knee will approximate natural human cartilage to an extent significant enough to provide substantial benefit to the patient.
Because ACI is in its infancy, questions remain about the long-term efficacy of the procedure.
Other available treatments for a defect in articular cartilage of the knee include, abrasion chondroplasty, arthroscopic microfracture or drilling, osteochondral autograft surgery or “plugs”, and an osteochondral allograft using transplanted tissue from a cadaver (collectively, "conventional interventions"). Each of these procedures is, standing alone, less expensive than ACI.
Each of these procedures, whether used singly or in combination, is not appropriate for Witherspoon at this time. Individually and collectively, conventional interventions afford no realistic hope of providing any noticeable relief for his symptoms, nor will they forestall the deterioration of his knee.
The evidence establishes that there are no viable alternatives to ACI in the facts and circumstances of this case. Witherspoon is either not a candidate for conventional interventions, or has had such treatments and they have failed.
Of the three Board-certified orthopedic surgeons who testified, AHCA's expert, who has never performed ACI, opined that Witherspoon could be treated by conventional interventions and Witherspoon's experts, who do perform ACI, testified that conventional interventions have failed and will continue to fail.
There is no evidence to suggest that the testimony of any of the doctors was tainted by personal financial considerations of any kind.
The ACI procedure, if successful, would be less expensive than a continuing course of short-term "housekeeping" treatments. Conventional interventions would, at most, stave off the inevitable knee replacement. They would not alleviate Witherspoon's disability in any way.
Reliable evidence establishes that the ACI procedure presents the only possibility of providing Witherspoon with significant benefits toward recovery and well being.
AHCA stipulates and the evidence establishes that ACI has been established to be safe.
Under the facts and circumstances of this case, the benefits of the ACI procedure outweigh the risks to Witherspoon.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction of the subject matter and over the parties pursuant to Subsections 120.569 and 120.57(1), Florida Statutes.
The power of AHCA to order that the ACI be provided to Petitioner is derived from Subsection 440.13(1)(m), Florida Statutes, and Rule Chapter 59B-11, Florida Administrative Code.
Subsection 440.13(1)(m), Florida Statutes, provides, in pertinent part:
(m) "Medically necessary" means any medical service or medical supply which is used to identify or treat an illness or injury, is appropriate to the patient's diagnosis and status of recovery, and is consistent with the location of service, the level of care provided, and applicable practice parameters. The service should be widely accepted among practicing health care providers, based on scientific criteria, and determined to be reasonably safe. The service must not be of an experimental, investigative, or research nature, except in those instances in which prior approval of the Agency for Health Care Administration
has been obtained. The Agency for Health Care Administration shall adopt rules providing for such approval on a case-by- case basis when the service or supply is shown to have significant benefits to the recovery and well-being of the patient.
Rule 59B-11.002(5), Florida Administrative Code, provides, in pertinent part:
"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. . . .
* * *
The ACI procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. See DOAH Case No. 00-0775, Rebecca Crane vs. Agency for Health Care Administration, and DOAH Case No. 99-4954, Sally Nolder vs. Agency for Health Care Administration.
Rule 59B-11.004(3), Florida Administrative Code, provides, in pertinent part:
(3) 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.
Rule 59B-11.002(7), Florida Administrative Code,
provides:
"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. In cases where the injured employee cannot return to gainful employment, "significant benefits to the recovery and well being of the injured employee" means 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 independently perform the activities of daily living.
Rule 59B-11.004(5), Florida Administrative Code, provides:
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.
Petitioner has fulfilled, by a preponderance of the evidence, the criteria for approval of this investigative procedure under the facts and circumstances of this case.
The evidence establishes that the existing studies of the ACI procedure are imperfect in ways acknowledged by the studies' authors. However, the imperfections are attributable to the newness of the procedure and the relative rarity of Witherspoon's particular combination of knee injuries. Indeed, the evidence establishes that it is in the nature of orthopedic medicine that no two injuries are exactly alike, making controlled studies difficult not just in knee joint cases, but also across the entire spectrum of orthopedic research. Reliable sources of information where medical researchers have expressed their conclusions in a scientifically appropriate manner inform the opinion(s) of Witherspoon's experts that, within a reasonable degree of medical certainty, ACI provides the best chance- as high as 90 percent- for Witherspoon to have a significantly healthier knee joint.
The deeply held belief of Witherspoon's treating physician, as well as an out-of-state expert who is well familiar with ACI, that the ACI procedure has a substantial chance of producing positive net beneficial effects which outweigh harmful effects in relation to existing alternative procedures, and for which the cost is comparable to the price of ineffectual, stop-gap measures, further supports the conclusion that ACI will provide significant benefit to the recovery and well being of Witherspoon. Indeed, it is the only realistic hope that Witherspoon can be restored to full employment as a police officer.
Based upon the foregoing, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order approving the proposed ACI for the Petitioner.
DONE AND ENTERED this 24th day of April, 2001, in Tallahassee, Leon County, Florida.
Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 2001.
Barry A. Pemsler, Esquire
Michelle L. Oxman, Esquire
Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
