The meeting was called to order at 10:18 a.m. by Eliot Rosenkranz, M.D., chairperson. The meeting was facilitated by Dr. Rosenkranz.

Transcription

1 Agency for Health Care Administration Organ Transplant Advisory Council Minutes February 2, 2009 Holiday Inn Select, Orlando International Airport 5750 T.G. Lee Blvd. Orlando, FL Members present: Members absent: AHCA staff present: Michael Angelis, M.D. Dr. Nasimul Ahsan Kim Kellum Dr. Thomas Beaver Dr. David Kramer Michael Bolin Dr. Robin Kim Theresa Kumar Dr. Richard Neiberger Mary McCullough Dr. Justin Nguyen Dr. Michael Nieder Dr. Eliot Rosenkranz Dr. Charles Sanders Dr. Pamela Schuler Dr. Juan Scornik I. Meeting Called to Order The meeting was called to order at 10:18 a.m. by Eliot Rosenkranz, M.D., chairperson. The meeting was facilitated by Dr. Rosenkranz. II. Introduction of New Member New member, Michael Angelis, M.D., was introduced to the council. III. Minutes After a brief discussion about the minutes, a motion was made, seconded and passed to accept the minutes from the October 06, 2008, meeting without correction. IV. Jackson Memorial Hospital Intestinal/Multivisceral Transplant Program Application A motion was made, seconded and passed to accept the Jackson Memorial Hospital application for intestinal/multivisceral transplants. V. Mayo Clinic/St. Luke s Hospital Lung Transplant Program Application Page 1 of 5

2 A motion was made, seconded and passed to accept the Mayo Clinic/St. Lukes Hospital application for lung transplants. VI. Florida Hospital Liver Transplant Program Application The council commended Florida Hospital for the comment section of the application and found this very helpful. For this reason, the council moved, seconded and approved a request that a cover letter be sent along with the application requesting that comments be brief, but include a summary of outcomes and a brief history of the approval from the United Network of Organ Sharing (UNOS) and the Centers for Medicare and Medicaid Services (CMS). 1 After discussion, the council moved, seconded, and approved the Florida Hospital Liver Transplant program. Dr. Michael Angelis recused himself from the voting. VII. Florida Hospital Pancreas Transplant Program Application After discussion, the council moved, seconded, and approved the Florida Hospital Pancreas Transplant program. Dr. Michael Angelis recused himself from the voting. VIII. Out-of-State Referrals Dr. Shuler brought up discussion of an issue concerning referral to programs out-of-state that are not Medicare approved. She referred a pediatric lung patient to a facility where this was the case. Her facility does not currently transplant lungs in patients under the age of 12. Particularly in those facilities where they treat only pediatric patients, there apparently has not been a need to seek Medicare approval. Many of these facilities are affiliated with hospitals that have Medicare approval and those patients who were covered by Medicare would be transferred to them. The patient that she was trying to refer actually did not end up needing the out-of-state referral. Mr. Bolin informed the council that the out-of-state process is being evaluated in Florida Medicaid. One of the things that may come out of this evaluation is to pre-negotiate reimbursement with facilities before the need arises. A council member acknowledged that, hopefully, this is a temporary problem and wants to see that there are facilities to handle any transplant issue for Florida. IX. Site Review Criteria Page 2 of 5

3 The council was educated on the CMS transplant program review process by the Agency for Health Care Administration (AHCA). In addition, the council was given a copy of the site review criteria published by CMS. The council requested that these survey reports be forwarded to them for review with program applications. The council determined that the following elements be added for review during a site visit: Organ-specific professional association s guidelines (listed in the State Plan) Current physicians and support staff o List personnel changes since last CMS accreditation Facility o Important changes in facility site o Review physical plant to determine: ICU age appropriate Recovery room Clinic space (TB patient next door to lung transplant patient) Review any deficiencies listed on the CMS or other certified organization surveys or reports o Review covered measures taken X. Transplant Outcome Data Study There was discussion regarding a study of transplant issues as it relates to Medicaid. The discussion centers on outcomes and access to care. The council moved, seconded and approved a motion to: Explore the availability of Department of Health funding to support research project. Develop a brief letter to the transplant centers and find out if the centers collect data for this project for access. Investigate the current state database on Medicaid patients to see if there is adequate data collected. 2 XI. Revision of Bylaws Staff presented the bylaws with suggestions for updating them. The council moved, seconded and approved the following changes to the bylaws: The statute giving the OTAC authority listed in the bylaws is outdated ( Florida Statutes) and needs to be current to read Florida Statutes. Page 3 of 5

4 The bylaws refer to the Director of the Agency in several sentences. The title of the Director is now Secretary. The bylaws should reflect Secretary of the Agency in place of Director of the Agency. XII. Policy of Approval of Transplant Programs The council moved, seconded and approved pediatric age guidelines to be consistent with the Certificate of Need rules established by AHCA. Counsel for AHCA, Kim Kellum, will review the State Plan supplement to determine whether this definition would be applied to the State Plan, formulated in a rule, or is necessary to define in any other document. 3 XIII. Re-Evaluation of Transplant Programs The council determined that a re-evaluation process for transplant programs should be to review their CMS report every three years. The council asked for a list of CMS (AHCA) reviewed transplant programs to be presented at the next available meeting. A three year review should include an up-to-date UNOS/Organ Procurement and Transplantation Network (OPTN) or Foundation for the Accreditation of Cellular Therapy (FACT) certification. 4 XIV. New Business Ms. Kumar reminded council members that their two-year terms will expire this year. She informed them that they may continue to serve if they are interested. The council members are not required to respond at this point, but were encouraged to consider reappointment when the time comes. Discussion centered on the type of meeting that the council members preferred going forward. The members prefer shorter telephone conferences more often and discuss one or two agenda items at a time. XV. Adjourn Meeting was adjourned at 2:25 pm. The next Organ Transplant Advisory Council meeting will be scheduled in 3-4 months and will be a telephone conference with one or two agenda items. These minutes are a summary of what transpired at the meeting. An actual transcript is available with Medicaid Services as produced by Executive Court Reporting Services. Action Items Page 4 of 5

5 1. Staff to include a cover letter with a transplant program application requesting that comments be brief, but include a summary of outcomes and a brief history of the approval from the United Network of Organ Sharing (UNOS) and the Centers for Medicare and Medicaid Services (CMS). 2. Council to look at funding from a grant source for a study; formulation of a letter to facilities to determine whether a database is available for the collection of information; and plan to look over data elements available from the state to determine study parameters. 3. Medicaid counsel will review the State Plan supplement to determine whether the definition of pediatric age guidelines being consistent with the Certificate of Need rules would be applied to the State Plan, formulated in a rule, or is necessary to define in any other document. 4. The council asked for a list of CMS (AHCA) reviewed transplant programs to be presented at the next available meeting. A three year review should include an up-to-date UNOS/OPTN or FACT certification. Page 5 of 5