University of Pittsburgh
May 3, 2006

Pitt Law Clinic Wins Three-Year Battle Resulting in Major Medicare Policy Change

Pitt law clinic students challenged the National Coverage Decision on pancreas transplants as outdated and not in step with the latest research to secure new policy
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PITTSBURGH-University of Pittsburgh School of Law students working in Pitt's Health Law Clinic have won a three-year battle on behalf of their client, Sharon Reigh of State College, resulting in the Centers for Medicare and Medicaid Services (CMS) to change their National Coverage Decision (NCD) policy on pancreas transplants. The decision to cover solitary pancreas transplants became effective April 26.

For the last three years, law students under the direction of Stella Smetanka, Pitt clinical associate professor of law, have been fighting to change the NCD policy so Reigh, who suffers from diabetes, could receive a new pancreas. Her illness caused a condition known as hypoglycemic unawareness, in which patients can fall into a diabetic coma without warning. If this happens when a person is sleeping, death is a possibility.

In 1995, Medicare published an NCD stating that pancreas transplants would be covered only if the patient also needed a kidney, allowing no provision for a solitary pancreas transplant even if a patient's condition was life threatening.

Reigh's endocrinologist recommended her for a pancreas transplant. At the time, she was on Social Security Disability, so her primary health coverage was through Medicare. Because the NCD on pancreas transplants did not allow solitary transplants, coverage for Reigh's transplant was refused.

A UPMC Medicare coordinator brought Reigh's situation to the attention of the law clinic. Medicare advocates from around the country urged Pitt's law clinic, who appealed the denial of coverage, to try the case.

Ron Shapiro, professor of surgery in the University's School of Medicine and director of renal, pancreas, and islet transplantation at the Thomas E. Starzl Transplantation Institute, testified on Reigh's behalf at the hearing. Because of her debilitated condition, Reigh testified via phone from her home. The appeal was denied because the administrative law judge did not have jurisdiction to overturn this NCD. In 2003, Congress made it possible for individuals to mount challenges to NCDs. Using this new route of appeal, law students argued that the NCD governing solitary pancreas transplants was outdated and not in keeping with the latest research.

Fortunately for Reigh, she had a secondary insurer willing to make an exception to its policy and become the primary insurer over Medicare. In February 2004, she received a pancreas transplant at UPMC and is doing well.

In the meantime, CMS's Departmental Hearings Board agreed in July 2005 that Pitt law clinic's arguments had merit and decided to open up the restrictive NCD for national comment and a reconsideration of the policy. Ngoc Thai, director of pancreas transplantation at the Starzl Institute and associate professor of surgery in Pitt's School of Medicine, wrote a persuasive comment in favor of the reconsideration and traveled to Baltimore to speak with CMS representatives about the issue as an invited expert. Based on comments offered in support of the law clinic's position, CMS proposed a change in January, giving way to the recent decision to grant solitary pancreas transplants in certain limited situations as when a person suffers from Type 1 diabetes and unawareness of the condition of hypoglycemia.

According to Smetanka, since accepting Reigh's case in September 2002, six different teams of law students have worked on it, doing everything from representing Reigh at the first hearing, researching the latest scientific developments, working with medical students who rotate through Pitt's law clinic weekly, collaborating with Shapiro at the Starzl Center, and drafting the compelling legal arguments that made the case successful.

The two Pitt law students who worked on the case this past term are graduating at the end of the month. Of the students who worked on the winning brief, one is a practicing attorney in Washington, D.C., and the other works at a law firm in Pittsburgh.