Conclusions Having reviewed the Notice of Intent to Deem Application Incomplete and Withdrawn from Further Review dated October 19, 2010, attached hereto and incorporated herein (Ex. 1), and being advised that the Petitioner has voluntarily withdrawn its request for a formal hearing dated August 2, 2011 (Ex.2), and being advised of all other matters of record, the Agency for Health Care Administration (“Agency”), finds and concludes as follows: ORDERED: 1. The Petitioner's initial application for health care licensure is withdrawn. 2. The Petitioner's request for a formal hearing is withdrawn. 3. The Agency’s Notice of Intent to Deem Application Incomplete and Withdrawn from Further Review is moot and thus is withdrawn. DONE and ORDERED this /7 day of Leger , 2011, in Tallahassee, Leon County, Florida. Elizabeth Dudek, Secretary alth Care Administration A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW OF PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: | Timothy G. Schoenwalder, Esquire 204 South Monroe Street Tallahassee, Florida 32301 (U.S. Mail) Warren J. Bird | Assistant General Counsel Agency for Health Care Administration (Interoffice Mail) Jan Mills Facilities Intake Unit Agency for Health Care Administration (Interoffice Mail) Roger Bell Health Care Clinic Unit Manager Agency for Health Care Administration (Interoffice Mail) Errol H. Powell Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399 (U.S. Mail) CERTIFICATE OF SERVICE ] HEREBY CERTIFY that a true and correct copy of this Final Order was served on the above-named person(s) and entities by U.S. Mail, or the method designated, on this the 78 day of as cz ‘2011. Richard Shoop, Agency C Agency for Health Care Administration 2727 Mahan Drive, Building #3
The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation (ACI) procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact 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.
Recommendation 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. FLORENCE SNYDER RIVAS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 2001. COPIES FURNISHED: Barry A. Pemsler, Esquire 307 Ros Centre 770 Ponce de Leon Boulevard Coral Gables, Florida 33134 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Mail Stop 3 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
