Fight of a Lifetime
photography by denmarsh
Sharon Reigh was slowly dying. As was any hope she might have had for reversing her ill health. Her one and only hope for survival was a pancreas transplant—a transplant that her doctors believed she desperately needed, and a transplant Medicare had disallowed. She continued, in vain, to petition Medicare, insurance companies, and any and all other avenues for help. By early 2002, after enduring years of life-threatening complications from diabetes and years of searching for help, Reigh had all but given up, feeling progressively powerless and increasingly fearful. Yet, within a few months’ time, her case would be referred by a case manager at UPMC’s Thomas E. Starzl Transplantation Institute to the Pitt Health Law Clinic. And Sharon Reigh would suddenly feel as if maybe—just maybe—she had been given one more chance at life.
She instinctively knew this case would be difficult. Stella Smetanka, Pitt Clinical Professor of Law and Director of the Pitt Health Law Clinic, had gone over the Sharon Reigh case in her mind dozens of times. From discussions with the Starzl Transplantation Institute, Smetanka knew that this case would involve fighting for a specific exception to a long-standing Medicare National Coverage Decision (NCD) denying coverage of solitary pancreas transplants. Nevertheless, after careful consideration and much research, Smetanka decided the Clinic would take the case. Smetanka knew the Clinic faced a daunting legal struggle.
What Smetanka could not know in 2002 was the profound national impact their work would ultimately have. It was an effort that would take 3 1/2 years, five teams of students over six semesters, and the expert guidance and supervision of Stella Smetanka. But the Clinic’s work would help save the lives of hundreds of people each and every year— people who, like Reigh, would have died slow, agonizing deaths for lack of a pancreas transplant.
It began like many other cases, challenging a Medicare decision in a specific case under a unique set of circumstances.
But the Sharon Reigh case would, indeed, be different.
In other Medicare challenges the Clinic had undertaken, there had been no set prohibition against a specific type of coverage. Smetanka and her Clinic students knew that in this case, the stumbling block would be the 1995 NCD. This decision stipulated that a pancreas transplant could be covered only in conjunction with a kidney transplant. In other words, a patient had to be in renal failure as a complication of diabetes in order to receive a pancreas transplant.
A Type I diabetic for 33 years, Reigh’s disease triggered a multitude of complications, the most severe of which was hypoglycemic unawareness that left her disabled, out of work, and living in absolute fear.
An uncontrollable condition that causes blood sugar to plummet suddenly and without warning, hypoglycemic unawareness can precipitate diabetic coma or death. “My blood sugar went up and down so wildly and insulin regimens had no effect,” explained Reigh. “I had so many episodes where I would pass out—with no symptoms, no warning. I was constantly checking my insulin levels. And I could not be left alone knowing that I could pass out and fall into a diabetic coma. I got to the point where I was afraid to go to bed at night, fearing that I wouldn’t wake up again.”
Reigh’s other complications included acute gastro paresis which dramatically slows digestion and impairs insulin absorption; nerve damage in her feet, legs and hands; and vision complications from retinopathy.
Sharon Reigh was, indeed, slowly dying from the life-threatening complications of diabetes.
She felt utterly helpless, having petitioned Medicare and her secondary insurer, only to be told the transplant was “experimental” and “not medically necessary.”
She felt progressively sicker from stomach nausea and pain, nerve damage and ricocheting insulin levels.
She felt absolute terror at the thought of merely going to bed each night.
But her kidneys functioned well.
“We believed that Sharon Reigh was being unfairly denied a pancreas transplant—in the face of life-threatening complications of her disease—just because her kidneys were good,” said Smetanka.
The Clinic students discovered that Medicare had based its original 1995 decision on pre-1995 medical evidence showing that transplantation of both the kidney and pancreas resulted in higher survival rates and lower organ rejection when compared to solitary pancreas transplantation alone. However, the students also discovered that since the 1995 decision, solitary pancreas transplantation outcomes had greatly improved.
Armed with that evidence as well as statements from Reigh’s doctors citing her need for the transplant, Smetanka decided to try the case in 2003 in a hearing before the Social Security Administration’s Administrative Law Judge (ALJ). The Clinic hoped to prevail in this setting as it had many times before when challenging a Medicare denial.
Dr. Shapiro, pancreas transplant surgeon at the Starzl Transplantation Institute testified on her behalf. Reigh testified by phone, too sick to come to the hearing.
The Clinic lost. The judge commented that he could not issue a ruling contrary to Medicare’s national policy since the matter was out of his jurisdiction.
The defeat was staggering— for Reigh, for Smetanka and for the Clinic students who had worked so very hard preparing this case.
Echoing in Stella Smetanka’s ears were the words of Sharon Reigh, “When I received my initial letter from Medicare saying that I had been denied coverage for a transplant—a transplant both my doctors and I knew I desperately needed—it felt as if I had just been handed a death sentence. And in effect, I had.”
Deeply convinced that Sharon Reigh was suffering unnecessarily and unjustly, Smetanka decided to continue the fight. Smetanka still believed that the crux of the case lay in the student’s initial research. Their premise was that pancreas transplants, when originally developed had been considered “experimental” and “investigational,” and as such, had not warranted Medicare coverage. But, given the advances in pancreas transplantation over the last 10 years, the original NCD now was obsolete.
Led by Smetanka, Pitt Clinic students began an intense period of research, “finding evidence that really began to turn the tide,” said Smetanka. “We documented dramatic advances that had occurred in the science and practice of transplantation over the past 10 years. The disparity between the NCD’s science and current medical evidence had become increasingly evident to us,” said Jeff Cadle, ’05, who had worked on the case as a Clinic student.
More convinced than ever, Smetanka now knew that it was an outdated NCD standing between Sharon Reigh and a pancreas transplant. And Smetanka now knew what the Clinic’s next steps had to be. They would challenge the existing NCD—a move considered highly unusual. Challenges to the Centers for Medicare and Medicaid were rarely prompted by individual cases. Rather, such challenges to broad national policy traditionally fell to national organizations such as large U.S. transplant centers or professional organizations such as the American Society of Transplant Surgeons.
Yet, remaining undeterred, the Clinic launched their challenge in 2004, inaugurating a 2 1/2 year legal process that now carried a much broader national significance.
A significance not lost on the Clinic’s students. Anthony Choe, ’05, who had participated in the case as a third-year law student, commented, “In the back of our minds, we knew we were involved in something big—a case that had the potential to change public policy. We knew at the time there were very few analogies to this case at the Clinic where we could not only help an individual but also help an entire group of people.”
“The students really rose to the occasion,” recalled Smetanka. “They understood that this case presented broad learning opportunities for them—learning not only how to advocate for a client, but also how to research and interpret scientific studies, work with physicians, and then craft a legal argument. It was truly gratifying for me to see just how well all of the students responded.”
Designed with the twofold mission of educating law students and serving those who otherwise could not afford legal representation, the Pitt Health Law Clinic offers free legal guidance and support to those most in need. Under the expert supervision of Clinic Director Smetanka and certified by the Pennsylvania Supreme Court, Pitt Law students directly represent clients. They are often involved in client work challenging denial of disability benefits by the Social Security Administration or Medicare denials of coverage. They gain valuable trial experience—such as gathering expert opinions and crossexamining experts. A one-semester course, the Clinic allows students to become involved in ongoing casework.
And so, each semester for nearly 3 1/2 years, different teams of Clinic students became actively involved in the Sharon Reigh case. Each team was important in its own way, making significant contributions within every phase of the case.
As the years went by and the legal process unfolded, they conducted research, attended hearings, worked with the Starzl Transplantation Institute, sought statements from doctors, clinics, and health plans from across the country, and drafted legal arguments. The student teams operated like a well-orchestrated relay, passing the baton from one team to the next.
“And orchestrating it all was Professor Smetanka,” says Choe, “who never let us miss a beat. Passionate about the case, she set the tone for our work, was a guiding force in moving the case forward and was instrumental in our learning process. She understood the case front to back, and provided guidance on where we needed to go, always helping us take the next step.”
And in the Reigh case, that next step was a momentous leap onto the national stage. In July of 2004, the Clinic filed its complaint with the Departmental Appeals Board of the U.S. Department of Health and Human Services in a challenge of the existing National Coverage Decision on solitary pancreas transplants. Upon acceptance of the complaint by the Appeals Board, the Clinic subsequently filed an Aggrieved Party Statement in the fall of 2004.
Anthony Choe, who co-wrote the Aggrieved Party Statement with Jeff Cadle said, “The burden was on us to demonstrate that the practice and science of pancreas transplantation had significantly improved to warrant a reconsideration of the current decision.”
Ultimately, they argued that pancreas transplants, having begun as an experimental procedure, were now a common surgical procedure with significantly improved outcomes. The solitary pancreas graft survival rate had now exceeded those of dual pancreas and kidney transplantation procedures. In addition, the drug therapy had also significantly improved over the last 10 years, improving the quality of life post-transplantation. And they argued that numerous private health insurers were already covering the procedure. These private insurers, along with the American Diabetes Association, determined that pancreas transplants could significantly improve the quality of life by eliminating the need for insulin therapy and by eliminating life-threatening complications such as hypoglycemic unawareness.
Ironically in 2004, Reigh ultimately received a pancreas transplant, covered by her secondary insurer on a specific-case basis. Nevertheless, Smetanka had decided to pursue their challenge—on behalf of Sharon Reigh, but also on behalf of the hundreds of patients across America who were being denied a life-saving pancreas transplant.
“Stella and the Clinic kept fighting,” said Reigh. “And I thought that was so important. I didn’t want to see anyone else have to suffer the way I did—fighting for my life while fighting with a bureaucracy. She fought for those too sick to fight for themselves.”
Smetanka added, “We, like Sharon, also thought it important to continue the fight. For this case was not only about championing the rights of our client, but about fighting for justice in the system.”
And justice did prevail.
The Department of Health and Human Services concluded that the burden of proof had been met. And on April 26, 2006, after review by the Centers for Medicare and Medicaid Services and periods of public comment, Medicare’s new National Coverage Decision covering solitary pancreas transplants took effect.
For Sharon Reigh, the victory was overwhelming.
“This meant so much to me. Stella Smetanka and the Pitt Clinic took my case when no one else would. If it wasn’t for Stella and the great group of law students, none of this would ever have happened. They just took the case and ran with it.
“And the funny thing is, I never met Stella or the students. I had been too sick to travel from State College, PA, to Pittsburgh. So, we only talked by phone. Stella listened to what I had to say—not only about myself, but about all the others being denied pancreas transplants and dying because of it. Her caring and devotion to this case were unbelievable. I have never met anyone quite like her.”
For the students, the entire process was unparalleled.
Each of the 12 students involved in this case have now embarked on their own legal careers. But they hearken back to this one legal experience as one that truly made a difference—in the life of their client, in the lives of people all over the country, and in their own legal training.
As Jeff Cadle, now an associate at Thomas A. Will & Associates in Pittsburgh, PA, said, “It was an honor to have been part of this effort. And the Clinic—it was an unbelievably invaluable learning experience. As a result, I had a virtually seamless transition from law school to law firm.”
Anthony Choe, now an associate in the Health Care group of Arent Fox in Washington, D.C., also remarked that the experience “was the highlight of my law school career. Helping to bring about a national policy change was an empowering experience, and helping someone in need was personally very satisfying.”
And for Stella Smetanka, the victory was truly gratifying.
“There are so many people in desperate need of legal services, and we, at the Clinic, wish we could help a greater number of them,” she said. “So, to realize that through this one pro bono case, the Health Law Clinic was able to help hundreds of people all over the country, who, just like Sharon, would have died without a pancreas transplant—well, it was, indeed, a most gratifying outcome.”