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July Public Policy Report

ORGAN TRANSPORTATION ACTIVITIES

Transportation of recovered organs from donor hospitals to transplant centers is certainly one of the most important aspects needed for a successful transplantation network. Since 9/11, the use of commercial airplanes for transportation has been severely impacted in very negative ways.


Prior to 9/11, transported organs typically were placed in the cockpits when boarded on commercial flights. There was a “first on, first off” policy to make sure that organs were on their way from donor hospital to transplant center as quickly and efficiently as possible.


With the heightened security concerns required on airlines post 9/11, organs were delivered to cargo depots for the various airlines and loaded as any other luggage would be loaded on these planes. This led to a number of unintended consequences in organ transport. Missed deadlines at cargo offices, less than timely unloading of the baggage, and a number of others meant that organs didn’t get from donor center to transplant center so quickly as needed.


Now, UNOS has written a letter to the senior members of Congress who oversee Congressional oversight of the Federal Aviation Administration, with a large number of patient groups signing on to this letter in support of its objectives. This letter requests as follows:

“… a legislative provision in the FAA reauthorization that would require the FAA to develop regulations to enable the safe and efficient delivery of human organs intended for transplant to the gate of a commercial airplane, and carriage of these organs securely within the passenger cabin.”

We’ll continue to monitor this activity as events unfold.


Testing for organ rejection

TRIO has agreed to spearhead an effort to reverse a Medicare decision to stop paying for the use of cell-free DNA blood testing to monitor organ rejection. What is cell-free DNA and how does it indicate rejection?


As anyone in the transplant community knows, the possibility of organ rejection can occur at any time. Infections, fevers, or changes in immune suppression can bring on a rejection episode as the body discovers there’s something “foreign’ hanging around and rouses the immune system to begin its attack. Occasionally, organ rejection has begun and is so advanced when discovered that it isn’t possible to reverse course. And signs of organ rejection differ from organ to organ.


In the past, regularly scheduled clinical visits have been needed to monitor the health and longevity of the transplant organ. In many cases, diagnostic tests have required the use of biopsies of transplanted organs to test for signs of rejection. Hearts, lungs, livers, and even kidneys are organs that may have to undergo a biopsy. Biopsies may include just a needle inserted through the skin to obtain tissue from the organ or may need a surgical procedure to obtain organ tissue for review.


Since its discovery in 1948, the utility of cfDNA has been studied extensively in screening, diagnosis, prognosis, therapy and monitoring disease progression. Although effort has focused on cancer, and mostly in NSCLC, other areas of research are ongoing, including autoimmune disease, metabolic disorders, Alzheimer’s disease, and other neurologic conditions, COVID-19, myocarditis and dilated cardiomyopathy, and refractory epilepsy. And now organ rejection can be added to the monitoring capabilities of this practice.


Donor derived cell-free DNA, or DD cfDNA, has become a standard practice in numerous transplant clinics to be used to test for organ rejection. DD cfDNA occurs when DNA is shed from a donor organ into the blood stream as a marker of organ rejection starting. So a blood test has been developed to look for this marker and allow clinicians to begin reversing the course of rejection.


Watch this space for additional news about participating in TRIO’s efforts to reverse this very harmful decision at Medicare.


PART D ACTIVITIES

We have been reporting the activities of the Partnership for Part D Access very consistently for the past several months and years. And the Partnership continues to work on behalf of maintaining the flow of prescription drugs for the transplant community and the other five covered protected classes of patients.


Recently, activities with the Partnership have accelerated along several fronts:

The Partnership has arranged dozens of meetings with legislative staff members throughout the Senate and House. Partnership staffers and patient representatives from the protected classes have been educating the staffers about the importance of consistent access to all prescription drugs needed for patients in the classes.


In addition, the Partnership staff has discussed a congressional resolution planned for release this summer reaffirming the Congress’s commitment to keeping the protected classes unchanged. The Partnership is now in the process of securing additional Congressional sponsors in support of the resolution.


TRIO’s participation with the Partnership’s activities has been a very effective way of making sure our voice is heard by our elected national representatives. The Congressional staff members who have been a part of the meetings have all been interested in how patients in the protected classes continue to need support to maintain the Medicare policies that comprise Part D coverage.


STATE ACTIVITIES ON BEHALF OF LIVING DONATION

Last year, New York State passed the Living Donor Support Act to add significant benefits and protections for living donors.


Now, the coalition that worked tirelessly to see this act passed is back again for a second round. This time it’s to move up the timetable for the implementation of the additional benefits that were secured in December, 2022. Recently, Elaine Perlman, Executive Director of WaitListZero, met with the New York State Department of Health to discuss the implementation of the Living Donor Act. WaitListZero has put together a group of experts who manage living donor transplant programs and has suggested to the State that these groups assist in the implementation of the actual activities related to supporting living donors, both in the pre-transplant and post-transplant stages of living donation.


The efforts here in New York are meant to be a template for encouraging living donation across the country, continuing the push for more living donation. Living donation in recent years has decreased, as shown by data from UNOS (https://unos.org/data/). New York State’s efforts are meant to reverse that trend in very meaningful ways.

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