Pat Quinn, Governor Julie Hamos, Director

201 South Grand Avenue East Springfield, Illinois 62763-0002

Telephone: (217) 782-1200 TTY: (800) 526-5812

ILLINOIS MEDICAID POLICY ON MULTI-VISCERAL TRANSPLANTS FOR ADULTS

ILLINOIS MEDICAID POLICY Illinois Medicaid will not authorize coverage of Multi-Visceral Transplant (MVT) procedures for adults at this time. There is no peer-reviewed and published literature that demonstrates the effectiveness and safety of this procedure and, thus, it is experimental in nature. The policy will not be re-examined based on the specific circumstances of individual Medicaid clients. BASIS OF ILLINOIS MEDICAID POLICY This policy is based upon the unanimous recommendation of the Ad Hoc Professional Ethics Advisory Committee which met on May 17, 2013. The committee met for the purpose of assisting the Illinois Department of Healthcare and Family Services (HFS) in establishing a Medicaid policy for coverage of MVT for adults. AD HOC PROFESSIONAL ETHICS ADVISORY COMMITTEE BACKGROUND

On February 22, 2013, HFS received an informal request followed up with a formal request on March 7, 2013 from the Indiana University (IU) Transplant Surgery Team to prior-authorize the performance of MVT for two adult Medicaid clients. IU indicated that it would be submitting more prior authorization requests for the performance of MVT for adults. Although Illinois administrative rule authorizes MVT for children, it is silent on coverage of MVT for adults. Illinois Medicaid has not previously authorized and does not have written standards for approving MVT for adults. The Illinois State Medicaid Plan states that a transplant procedure will not be approved if the procedure is experimental, another procedure costing less or of less risk will achieve the same results, the transplant does not make a difference in the patients health and performing the transplant will merely serve an academic purpose, or the transplant is relatively unsafe given the age and prognosis of the individual. Illinois administrative rule requires hospitals performing transplants to be certified by HFS. Neither IU nor any other hospital is certified by HFS to perform MVT for adults. Illinois administrative rule establishes an exceptions process to the formal certification process. PURPOSE AND COMPOSITION OF AD HOC PROFESSIONAL ETHICS ADVISORY COMMITTEE

The Ad Hoc Professional Ethics Advisory Committee (Committee) met: To assist HFS regarding whether a policy should be adopted to approve MVT for adults.
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 If HFS adopted such a policy, to assist HFS in the establishment of written standards to ensure compliance with state and federal laws and regulations. The Committee was comprised of six members. The Committee members were requested to serve based on their qualifications, expertise, diversity, professional standing, record of service and leadership. The Committee members volunteered their services and received no compensation. Their backgrounds are: PhD-Vice President of Ethics at a hospital system; JD, LLM-Clinical Ethicist and Assistant Director of Ethics at a hospital system; MD (Internal Medicine and Cardiology) with highly responsible federal government experience; MD, MHA (Cardio Vascular Surgeon), Ethics Consultant, past president of a medical association; PhD, MSW, section chief of a state agency; and MD, senior director of community based practice at a large academic hospital system MEETING AND RECOMMENDATION OF AD HOC PROFESSIONAL ETHICS ADVISORY COMMITTEE

The Committee met on May 17, 2013. In addition to the Committee members, present were Director Julie Hamos, Dr. Arvind Goyal, HFS Medical Director, and Jeanette Badrov, HFS General Counsel. After careful consideration, the Committee made a unanimous recommendation to HFS that: As there is no peer-reviewed and published literature which demonstrates the effectiveness and safety of the MVT procedure and, thus, it is experimental in nature, Illinois Medicaid should not approve requests for coverage of MVT for adult patients at this time. The policy should not be based on the specific circumstances of individual Medicaid clients. BASIS OF RECOMMENDATION OF AD HOC PROFESSIONAL ETHICS ADVISORY COMMITTEE

The following information was presented to the Committee: Prior to the meeting, Dr. Goyal conducted a methodical and time intensive review which he shared with the Committee. Dr. Goyal consulted with two IU transplant surgeons and their lobbyist on the patients medical situations, reviewed their medical records including referral requests and test data, and reviewed the limited literature related to MVT. Dr. Goyal consulted with two transplant centers in Chicago, neither of which performed or offered MVT. Dr. Goyal engaged IU to understand their protocols, basis for their MVT recommendation, cost structure, volume of their cases (38 in 4 years) and patient outcomes data. Dr. Goyal analyzed existing policy and relevant HFS claims data internally. Dr. Goyal studied, and in some cases held phone conferences, to learn coverage policies of Medicare, several other state Medicaid programs, and multiple private payers. Dr. Goyal investigated and verified that IU is on the list of Transplant Programs approved by Medicare to perform MVT procedures for adults with certain diagnoses. However, Medicare does not pay for MVTs for patients with diagnoses similar to one of the patients (who is covered under Medicare), as Dr. Goyal verified that IU had made no request to Medicare to cover the MVT procedure. Dr. Goyal confirmed that Illinois Medicaid has not certified IU to perform MVT for adults. Dr. Goyal also verified the credentials of the four transplant surgeons on the IU operating team. The Committee reviewed the two IU prior authorization requests containing patient specific information, a written request from IU on behalf of each patient, and a summary of pertinent parts of federal and state regulations and the Illinois State Medicaid Plan.
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 No Illinois hospital or Illinois transplant center currently performs or offers MVT. MVT has been performed at very few transplant centers around the world. The 2011 Milliman Research Report lists a decrease in the number of MVT procedures (Intestine with other organs) in the U.S., falling from 141 cases in 2007, to 104 in 2009, and then remaining stable at 106 in 2010 and 108 in 2011. The Committee members made the following observations: The IU Transplant Program and its transplant surgeons are reputable and qualified and IU is approved by Medicare to perform MVT procedures for adults with certain diagnoses. IU has performed a total of 38 MVTs since the inception of the IU MVT transplant program four years ago, but they have not been able to provide definitive and specific outcome data measuring post-op quality of life and lifespan in each of those 38 patients. IU stated that their results have improved since they started doing MVT procedures and guessed that 60-70% of the patients who had MVT within the last year may be alive at the end of 2 years. The anticipated benefits of the proposed procedures appear uncertain and questionable and the risks are significant. In addition to surgical challenges, there are challenges associated with donor match, timely transportation of organs, long hospitalization, lengthy recovery, required out-ofstate follow ups, and lifelong anti-rejection chemotherapy. The available published data, some of it by the IU transplant surgeons, did not allow for appropriate and reassuring conclusions regarding prognosis, quality of life and life expectancy after MVT procedures. The information supplied by IUs lobbyist and transplant surgeons did not address the patients awareness of the complicated nature of the recommended procedures, the risks and projected benefits, and whether any alternatives had been offered or explored with the patients. Patients end-of-life plans or advance directives were also not available. Complete costs of recommended procedures were not available from IU. IU suggested that it will likely cost over 1million dollars for each inpatient stay. These projections did not include other expected and significant expenses such as professional fees, pharmaceuticals and home care. The Committee reflected on the dearth of available resources, including Illinois Medicaids limited budget and financial resources and the general scarcity and long waiting lists for organs. Concerns were raised that a published article authored by several of IUs transplant surgeons and others, Annals of Surgery, Volume 255, Number 6, June, 2012, contained information that contraindicated the medical necessity for the MVT for one of the two Medicaid clients. Sufficient peer-reviewed literature on the subject of MVT does not exist, making it impossible to weigh the benefits against the risks.

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