Pitt law students working in the University’s Health Law Clinic have won a three-and-a-half-year battle on behalf of their client—Sharon Reigh of State College, Pa.—resulting in a decision by the Centers for Medicare and Medicaid Services (CMS) to begin covering pancreas-only transplants. The policy change took effect April 26.

Medicare had published a National Coverage Decision (NCD) in 1995 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.

But in September 2002, Pitt School of Law students under the direction of Stella Smetanka, clinical associate professor of law, began 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 may result.

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

A University of Pittsburgh Medical Center (UPMC) Medicare coordinator brought Reigh’s situation to the attention of the Pitt Health Law Clinic. Medicare advocates from around the country urged the clinic, which 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 Pitt/UPMC Thomas E. Starzl Transplantation Institute, testified on Reigh’s behalf at the hearing. Too ill to testify at the hearing herself, Reigh did so via phone from her home. The appeal was denied because the administrative law judge lacked jurisdiction to overturn this NCD.

But in 2003, Congress made it possible for individuals to challenge NCDs. Using this new route of appeal, law students argued that the NCD governing solitary pancreas transplants was out of step with the latest research.

Fortunately for Reigh, she had a secondary insurer willing to become her primary insurer and cover her pancreas transplant. She received a new pancreas at UPMC in February 2004, and is doing well.

In the meantime, CMS’s Departmental Hearings Board agreed in July 2005 that the 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 medical school, 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 supporting 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, such as when a person suffers from Type 1 diabetes and hypoglycemic unawareness.

According to Smetanka, six different teams of students worked on Reigh’s case since September 2002, 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 legal arguments.