DEVELOPMENTS AT UNOS
The press has started to report on substantial changes to UNOS that are being recommended by HRSA, the department at HHS that oversees UNOS and transplantation policy. We will continue to monitor the recommendations as they unfold and will report out to you as we receive the information.
Recently, the American Society of Nephrologists sent a letter to the Secretary of HHS (www.asn-online.org) in support of the efforts to review UNOS and consider changes. TRIO added its name to this letter.
We are following a recent bill that was introduced into the House called “Securing the US Organ Procurement and Transplantation Network Act”, HR 2544. We will continue to inform you of developments with this legislation as they occur.
One of the major topics of discussion is organ discards, organs that are recovered but aren’t subsequently used for transplant or any other use. We recently conducted an interview with Dr. Sumit Mohan, the chairperson of a major UNOS Committee that oversees organ utilization. There will be several additional interviews with Dr. Mohan in the near future; an article will then be made available about these interviews.
In addition, there was major press coverage to the results of the UNOS liver allocation policy that was implemented several years ago. The Committee is planning an article for the May e-newsletter issue that will discuss policy as it applies to both liver and kidney recovery, allocation, and distribution.
Changes to the organ system in the United States should be welcome as technological and medical advances continue. Registering to be an organ donor is still a reflection on all of us for this important social need and our ability to help our family, friends, neighbors, and all citizens.
FDA ANNOUNCES SUPPORT FOR BIVALENT COVID BOOSTER SHOT
The following press article just appeared on April 18, 2023, in support of a bivalent booster shot. As always, please consult your medical or transplant team for its guidance with your treatments.
“(Reuters) -The U.S. Food and Drug Administration on Tuesday authorized a second dose of the so-called bivalent COVID-19 vaccines for people aged 65 years of age and older, at least four months after their first shot. The agency also withdrew its emergency-use authorization for older messenger RNA vaccines as it aims to shift towards a simpler vaccination schedule with the use of newer Omicron-targeting shots. It authorized the so-called bivalent COVID boosters in August that target the BA.4 and BA.5 Omicron subvariants, along with the original strain of the coronavirus. The withdrawal or approval for Moderna Inc and Prizer-BIoNechs/older vaccines, which target the original coronavirus strain, comes at a time when the FDA plans to shift to an annual COVID booster campaign with an updated strain, similar to the way Americans get their flu shots.”
(Reporting by Leroy Leo in Bengaluru; Editing by Shinjini Ganguli)
The most complete description of the FDA guidance can be found at the following website:
Part D Coalition Update
TRIO remains an active participant in the coalition to maintain Medicare Part D coverage for the six protected classes of drugs, which include immunosuppressives; this group is called the Partnership for Part D Access (www.partdpartnership.org).
Congress is currently focused on the new budget. Hearings were planned at the end of March before the Senate Finance Committee and the House Ways and Means committee. These committees are responsible for Medicare funding. TRIO’s Public Policy committee will monitor any developments and share with membership.
As in the past, there are a number of opportunities for TRIO members to sign up for virtual and in-person meetings with key legislators to explain the work of the Part D Coalition on behalf of the patient communities that are represented. In recent weeks, TRIO members met with the staff of two Representatives, House Member Norton and House Member Dingell, as part of the Coalition’s outreach activities.
The Coalition is continuing its effort to introduce a proposed resolution in Congress this June on maintaining the protected classes. It will be sending out one-page descriptions with talking points and other background on the resolution. The committee will share this information with Chapter leadership and individual members; we encourage everyone to let their Congressperson know of the importance of the Part D protections to the transplant community.