TRIO Public Policy Committee Reports
TRIO's committee on public policy will be discussing issues of importance to transplant patients and then posting public policy statements on this page. We greatly value the input of all TRIO members.
Committee co-chairs:
Rodger Goodacre: This email address is being protected from spambots. You need JavaScript enabled to view it.
Ira Cooperman: This email address is being protected from spambots. You need JavaScript enabled to view it.
TRIO Leglislative Priorities
PUBLIC POLICY COMMITTEE TRIO E-NEWSLETTER, DECEMBER 2023
PART D UPDATETRIO has been a part of Part D prescription drug grassroots efforts for many years and our membership in the Part D Coalition continues.
The Partnership is now working with Senate staff to send a letter of support to CMS from the Senate Finance Committee. This effort is promoted by Senators Grassley and Brown, two long-time champions of the transplant community. This letter will again reiterate the Committee’s support for keeping intact the coverage under Medicare Part D for the 6 protected classes.
LEGISLATIVE UPDATE
Legislative activity continues in the progress of bills on behalf of the transplant community, donors and recipients alike. In particular, the Congress has been very supportive of new and innovative activities to increase transplantation and improve transplant outcomes.
Recently, this newsletter has highlighted the bills that have been introduced. We will continue to monitor legislative activities and progress, including informing the TRIO community of any new activities on the horizon.
TRIO AND THE NATIONAL ALLIANCE FOR CAREGIVING PRESS RELEASE
The National Alliance for Caregiving (NAC) is a national organization attending to the needs of caregivers and other non-professionals, such as families, for patients with all manner of chronic or acute diseases.
In November, 2023, NAC held a press conference to announce the publication of a new report entitled “Transplant Caregivers in the U.S.: A Call for System Change”. TRIO was pleased to participate in this conference to discuss caregiver activities for transplant recipients. In addition, the report calls for significant system recommendations to improve caregiver activities and outcomes. Ike Copperman, Vice-President of TRIO, talked about his 47+ years of care partner experience, 23 years in the pre-transplant phase and then 24 years since his spouse received a simultaneous kidney/pancreas transplant in June, 1999.
For more information about this report, or to find out how to receive this report, please contact Ike at This email address is being protected from spambots. You need JavaScript enabled to view it.
HONOR THE GIFT
The Honor The Gift (HTG) effort continues on behalf of restoring non-invasive organ rejection blood monitoring for transplant recipients. Surveillance testing has been restored for heart and lung recipients, but is still not available in surveillance mode for kidney recipients. In addition, research in a test for liver recipients continues to be stymied since CMS tacitly approved supporting the withdrawal of non-invasive testing.
The HTG Coalition is mounting a new effort. For 3 days in December, 2023, 200 people will meet in Washington; organized into teams, the people will go through Congress meeting with Senate and House legislators and their staffs to rally their support on behalf of restoring non-invasive surveillance testing for the kidney transplant community. Please follow this column for the outcomes of these meetings.
TRIO BOARD HOLDS 2023 ANNUAL MEETING IN WASHINGTON, DC
The TRIO Board of Directors met in Washington, DC, for its annual meeting on October 10 and October 11, 2023. The meeting was hosted by CURA Strategies at its offices in Crystal City.
The first day included a briefing from Patrick Meade of CURA on important legislative activities. TRIO has worked with CURA on “Honor The Gift” activities, including 1) successfully extending immunosuppressive coverage under Medicare beyond 3 years and, currently, 2) extending Medicare payment for non-invasive testing to diagnose solid organ rejection (in lieu of biopsies). On the second day, the annual meeting covered internal business related to TRIO, its chapters, and its financial condition.
At the conclusion of the meeting, TRIO accompanied Patrick to Capitol Hill. CURA had arranged an afternoon of visits to the offices of 6 Senators to discuss with Senate staff the legislative agenda that TRIO is championing. Board members Lorrinda Gray-Davis, Steve Okonek, Ike Copperman, Calvin Henry, and TRIO Executive Director Gary Green made the trip to Capitol Hill. The team visited the offices of Senate Majority Leader Schumer and Senators Warnock, Gillibrand, Rubio, and Van Holten to meet with their health staff members. There will be more information about TRIO’s legislative agenda in this newsletter and in upcoming correspondence.
TRIO is very grateful to the entire team at CURA Strategies for hosting this meeting.
NEXT STEPS FOR THE HONOR THE GIFT CAMPAIGN
Cura Strategies has developed a follow-up campaign to continue the efforts on behalf of non-invasive solid organ rejection testing. The next step is a major program to recruit 200 people from every state to come to Washington and participate in a new round of Hill visits to our congressional members.
More information about this effort will be coming out very shortly with emails to TRIO chapter leaders and members.
HR 2544 INTERVIEWS
The Health Resources and Services Administration (HRSA), the government agency under the Health and Human Resources Department, is responsible for oversite of UNOS/OPTN.
Over the past several months, HRSA has conducted dozens of interviews and focus groups to gather public input on the topic of UNOS modernization, in line with HR. 2544, Securing the U. S. Organ Procurement and Transplantation Network Act. This bill was signed into law in June, 2023; now HRSA has the responsibility to create plans to implement changes to the organ donation and transplant system in the US.
A number of TRIO members were among the public that participated in providing input to the HRSA information-gathering sessions.
FAA ASKED TO FIX ORGAN AIR TRANSPORTATION
House Representative Beth Van Duyne (R-TX 24) is sponsoring the Saving Organs One Flight at a Time Act (HR. 4362, https://www.govtrack.us/congress/bills/118/hr4362). This bill would restore putting solid organs back in the cockpits. After 9/11, organs were taken for transport to air cargo offices, where there were episodes of organs not being allowed to be taken even into cargo holds if they arrived at the cargo office too late. This bill would put the organs back in the cabin.
TRIO has signed onto a letter of support for this bill; we will keep you posted as it makes its way through the Congress.
September 2023
Since the last e-newsletter, the agenda has been quite full of activities and events affecting the transplant community.
MEDICARE COVERAGE OF NON-INVASIVE TESTS FOR ORGAN HEALTH
As has been reported earlier, non-invasive testing was halted for kidneys, lungs, and hearts last March when used for surveillance only purposes, as opposed to confirming organ rejection once detected. Since this halt, there has been a hailstorm of activity and newspaper coverage so that non-invasive heart and lung testing is now restored and covered by insurance and Medicare.
This leaves kidneys still not covered with vulnerable populations struggling to maintain transplant health. The Medicare contractor opened a public comment period to receive public input over its decision. This period closed on September 23rd, and now the community is waiting for information from the contractor.
TRIO was a very important part of a coalition led by Cura Strategies to point out the harms that can happen with such a change. We should receive more information from Cura in the upcoming weeks.
HR 2544
This past week, President Biden signed this bill, which now opens the door to allowing for-profit entities the ability to bid on managing and running the OPTN/UNOS system. It is expected that the Health Resources and Services Administration (HRSA) will release requests for bidding starting this Fall.
HRSA has provided a feedback mechanism for the public to weigh in on these changes to OPTN/UNOS. There is a template at the HRSA website to enter input. The instructions are as follows:
1. Go to HRSA’s feedback form: https://www.hrsa.gov/optn-modernization/contact
2. Follow this template to submit feedback: https://tinyurl.com/bdz4bwsz
3. Encourage your friends and family to do the same.
VACCINATIONS
Vaccinations are now available for the new strain of COVID as well as this year’s flu and also Respiratory Syncytial Virus (RSV). There is a very easy-to-use summary form that identifies who should get these vaccines. Please contact Ike Copperman at This email address is being protected from spambots. You need JavaScript enabled to view it. for a copy of this summary form.
As always, please work with your transplant team to determine the suitability of any of these vaccines for your individual situation.
In addition, COVID tests are now available through government sources. There is a very easy-to-use order form at the following link:
LEGISLATIVE AND GRASSROOTS EFFORTS ON BEHALF OF ORGAN DONATION AND TRANSPLANTATION
There has been a whirlwind of activity and attention through legislative and grassroots activities this year on behalf of organ donation and transplantation. With grassroots efforts, the following activities are underway:
Medicare Drug Coverage
Patient groups continue to work on behalf of the Part D six Protected Classes statutes. These statutes guarantee continued access to the prescription drugs needed by transplant recipients and the other five patient groups.
Medicare Coverage of DNA Tests for Organ Rejection
Another recent effort has started to restore access to non-invasive (no biopsy) monitoring of organ rejection. Earlier this year, CMS (Centers for Medicare and Medicaid) reversed course on the use of tests such as Allosure as part of regular blood test work. These non-invasive blood tests can now only be used to confirm the rejection is happening. A team called Honor The Gift2 has been meeting with members of Congress urging them to sign on to a letter asking CMS why it reversed course on its previous consent to use the blood test as a regular part of organ monitoring. This letter was co-sponsored by Members Eshoo and Burgess, long-time champions of the transplantation community. Recently TRIO was a very big part of a group that traveled to Washington and met with Representatives and Senators to educate them on the importance of cell-free DNA non-invasive blood testing. Lorrinda Gray-Davis, Ike Copperman, Cory Reynolds, and Emanuel Lewis from TRIO were in the group. We will continue to inform you of the activities on behalf of cell-free DNA testing.
Legislation To Support Living Donors
Because deceased donor organs are in short supply, there have been multiple efforts to increase and support living donation.
In New York State, lobbying efforts continue with the Department of Health (DOH) to implement the legislation signed by Governor Hochul in December, 2022. This legislation provides protections for living donors. The DOH has indicated that implementation of the legislation may not happen until no sooner than 2024. The group is pressing on DOH to pull out the stops and get it done in 2023. If you know of any state legislative activities, please inform us for a future e-newsletter issue.
On the federal level, there are several bills introduced in Congress on behalf of transplantation. A few of these involve modifying the existing NOTA (National Organ Transplantation Act) legislation of 1984.
The HOLD Act (Honor Our Living Donors) – This proposal is being presented by WaitListZero. Elaine Perlman, Executive Director, tells us that its intent is to make sure that living donors are compensated more appropriately than in current guidelines.
The Living Donor Protection Act (HR 2923/S 1384) – These bills have bipartisan support led by Representative Jerry Nadler. 120 members, Democrat and Republican, have signed on to turn these bills into law. The bills would prevent insurance companies from denying coverage to living donors for a variety of claims.
The Organ Donation Clarification Act (HR 4343) – This bill is co-sponsored by members Matsui and Wilson. It clarifies language in the NOTA Act to make sure living donors are eligible for payments for expenses incurred for donation, including long-term health insurance coverage for 10 years after a transplant. It also clarifies that UNOS can undertake research projects on behalf of transplantation that include reimbursements to donors.
Securing the US Organ Procurement and Transplantation Network Act (HR 2544/S 1668) – This bill has been passed by the Congress and sent to the President awaiting his signature. It modifies NOTA to allow the Secretary of HHS (Health and Human Services) to award pieces of managing the OPTN network to more than one entity, including for-profit organizations. OPTN has been managed only by UNOS since 1987.
Finally, an organization called ModifyNota.org is supporting an effort to modify NOTA to give substantial tax credits to living donors as a form of payment.
Please don’t forget that your individual voice speaks loudly on behalf of donation. The public comments window for UNOS Committee proposals is now open and available to you. The comment period ends on September 19th. Read about the activities and add your comments. You can link to this window through the following:
https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/If you have any questions or comments about this information, please contact Ike Copperman at This email address is being protected from spambots. You need JavaScript enabled to view it..
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.
June Public Policy Report
PATIENT PRESCRIPTION DRUG ASSISTANCE PROGRAMS
Transplant recipients are faced with the life-long prospect of prescription drugs for the long-term success of a solid organ transplant. Many of these drugs, even the generic versions, have become very expensive running into hundreds of dollars per month for 2, 3, even 4 or more different medications.
Most pharmaceutical companies manufacturing immunosuppressive drugs have patient assistance programs to help with purchasing these prescription medications. CMS has a website with information about how to use these programs, at the following location: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PAPData
In addition, the Asthma and Allergy Foundation also maintains an excellent website with information about patient assistance programs:https://aafa.org/advocacy/advocacy-resources/patient-assistance-medicine-drug-programs/
PART D COALITION UPDATE
TRIO continues its active participations in the Partnership for Part D Access which is a patient led collation committed to maintaining beneficiary access to the full range of drugs available under Medicare Part D. The Partnership has a special focus on maintaining the six protected classes of drugs under Part D which includes immunosuppressive drugs. We all of course know how important this is to our community as immunosuppressives are not interchangeable and often prescribed in combinations particular to individual transplant patients. We require consistency and stability and access to all versions of particular medications to protect our transplants. The Partnership has been working to have a Congressional Resolution passed in support of maintaining the six protected classes and is now visiting individual members of Congress to seek their support. During these visits they have found a number of misconceptions about the protected classes including the ideas that it does not allow drug plans to manage utilization, that it stymies the use of generic drugs, and that it drives up Medicare costs, none of which are true. The Partnership has found that during these visits to congress members that the voice of individual patients explaining how these drugs effect their lives is particularly effective in convincing individual members of Congress to sign on to the resolution to maintain the six protected classes. Our committee suggests that at any opportunity individual TRIO members or Chapters have or can create to speak with their Congressional representative should include a discussion of how important maintaining protection for the six protected classes is for the transplant community and encouragement of support for the Resolution.
EXECUTIVE BRANCH EFFORTS ON BEHALF OF CAREGIVERS AND CARE PARTNERS
The role of caregivers and care partners has never been more important in the American health system than in the past few years, as families coped with Covid and all the restrictions the pandemic required.
Most often unpaid activities, caregiving has assumed an immense role in providing safe and secure health care services to the patient and family communities.
In recognition of this growing role, President Biden announced an Executive Order in April of this year to enhance and strengthen federal programs that support caregivers. While many of the new and changed policies from the federal government have yet to be announced, TRIO is working with the National Alliance for Caregiving (www.caregiving.org) to create a webinar for transplant patients and caregivers to understand all the parts of the Executive Order and how it will affect our futures.
Please stay tuned to this column for additional information.
HONOR THE GIFT 2
Many of you may remember the Honor The Gift campaign launched several years ago to gather grassroots support on behalf of Living Donor Protection legislation making its way through the Congress. TRIO provided its support leading to the successful passage of the Living Donor bill.
The Honor The Gift coalition has launched a new campaign of vital interest to the transplant community and of major medical interest on behalf of patient safety. TRIO is proud to participate in this new campaign as we did in the first.
What is the new campaign doing? In recent years, major advancements have been made to test for potential organ rejection. Previously, painful and potentially harmful biopsies were carried out in heart, liver, and lung recipients to check for signs of rejection. And if detected, it meant that rejection had already begun.
However, the new testing procedures are blood work, accomplished during a recipient’s normal post-transplant visit followup. The new test can detect rejection even before it begins without the need for biopsies and the potential risk that biopsies entail. This new test involves looking for cell-free DNA (cfDNA) coming from the organ; this DNA is the donor DNA and shows that a potential rejection episode may be starting.
However, Medicare has recently launched an effort to restrict as well as eliminate the use of the cfDNA blood test during routine patient maintenance. The new Honor The Gift campaign will work to show Medicare that this new policy is poorly thought out and medically harmful to the transplant community.
We will send out notices as we receive the information about proceeding with the campaign.
May Public Policy Report
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:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccinesPart 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.April Public Policy Report 04/01/23
DEVELOPMENTS AT UNOSThe 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. Your Committee will continue to monitor the recommendations as they unfold and will report out to you as we receive the information.
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.
THREE YEARS OR SO AFTER COVIDDr. Marcus Pereira, director of the Transplant Infectious Diseases Program at NYP/Columbia Medical Center, sat for an interview with TRIO recently to talk about all things COVID:
- what do we know about it and what we don’t,
- how is it still affecting the United States,
- how are we treating it now,
- what does the future look like,
- and what does our community still need to practice.
Dr. Pereira said that Covid is in a steady state right now. There are still infections, hospitalizations, and deaths, but they are all declining. Early diagnosis with home tests and rapid antigen tests has made the disease much more amenable to treatment than before. Patients are less ill and the disease doesn’t last so long. The Pinetree study confirmed the use of Remdesivir for treatment of Covid, whether the patient needs hospitalization or not.
For the immunosuppressed community, caution and watchfulness are still needed. Covid has the potential for complications. Transplant recipients should not treat the disease on their own, especially with Paxlovid; the transplant team must be contacted and included in the discussion. Lowering immunosuppression medications is not a good idea unless the transplant team has been consulted. The advice is masking and still being aware of social settings with the possibility of infection.
However, Dr. Pereira points out that Covid continues to surprise the medical and immunology communities. It’s still not known if Covid acts like any other respiratory infection with seasonality aspects, although most scientists suspect it will be; and Covid has changed form many times in its 3 year history.
Dr. Pereira also addressed the use of Evusheld and Interferon. Evusheld was withdrawn from emergency use when it was found not to be effective against Omicron; however, Astra Zeneca has recently announced that Evusheld 2.0 is in trial, promising effectiveness against Omicron.
For the transplant community, the fact that Interferon boosts the immune system makes it mostly unsuitable for recipients.
We sincerely thank Dr. Marcus Pereira for his time, guidance, and good advice as we continue to manage through Covid.
For a list of the references that Dr. Pereira discussed during his interview, please consult the following:
THE CDC WEBSITE THAT TRACKS COVID IN THE US https://covid.cdc.gov/covid-data-tracker/#variant-proportions
AN ARTICLE BY A PHYSICIAN MEMBER OF THE FDA VACCINE APPROVAL PROCESS ON USING BIVALENT VACCINES https://www.nejm.org/doi/full/10.1056/NEJMp2215780
THE USE OF INTERFERON FOR COVID TREATMENT https://www.nejm.org/doi/full/10.1056/NEJMoa2209760#:~:text=Treatment%20with%20an%20exogenous%20source,SARS%2DCoV%2D2%20infection
ASTRAZENECA ANNOUNCEMENT ABOUT EVUSHELD 2.0 https://www.astrazeneca.com/media-centre/press-releases/2023/update-on-evusheld-us-eua.html
PART D COALITIONTRIO remains an active participant in a Coalition to maintain Medicare Part D coverage for the six protected classes of drugs, which include immunosuppressives.
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.
The Coalition is continuing its effort to introduce a proposed resolution in Congress this June on maintaining the protected classes. We should be receiving a survey soon to help best increase our leverage at future meetings with Congresspersons. The Coalition will also be sending out one-pagers with talking points and other background on the resolution. The committee will share this information with Chapter leadership and individual members and encourages everyone to let their Congressperson know of the importance of this protection to the transplant community.
PUBLIC POLICY REPORT FOR March, 2023
Immunosuppresive Drug CoverageMore drug coverage for end-stage renal disease—Medicare beneficiaries with end-stage renal disease previously lost their benefits 36 months after a kidney transplant, unless they were otherwise eligible for Medicare. But now they can apply for immunosuppressive drug coverage through a new benefit called Medicare Part B Immunosuppressive Drug, or Part B-ID, which started January 1, 2023.
The premium for this benefit is $97.10 per month in 2023. This benefit covers only continuous immunosuppressive drugs, and these beneficiaries cannot have other health coverage.
Partnership for Part D Access
There has been minimal activity with the Partnership’s activities as the US Legislature tries to resolve the budget and debt ceiling escalations.
The Partnership continues to work with its congressional champions to sponsor another non-binding resolution of support in 2023 for the Partnership’s goals.
TRIO continues to play an active role in all the monthly meetings.
Upcoming Reports
We are looking forward to sending out two articles in the very near future covering important topics.
The first article will discuss COVID vaccines for now and the future. There is a great deal of medical and pharmacological research occurring concerning the future of vaccines and vaccinations as the understanding grows that COVID will continue to be around for a very long time.
The second article will discuss the issue of kidney recovery and utilization. There will be an article on how the kidney recovery process works and how kidneys are chosen for use in transplantation. There is much work going on in the transplantation community about how to increase the number of kidney transplants every year; this article will focus on what’s happening!
PUBLIC POLICY REPORT FOR FEBRUARY, 2023
2022 Was a Banner Year for UNOSThe United Network for Organ Sharing (UNOS) ended 2022 with major accomplishments for organ, eye, and tissue transplants. This comes along with enacting significant efforts in organ distribution, bringing an organ from a donor hospital to the neediest waiting list candidate, to create more equity and efficiency in the transplant network.
In September, 2022, UNOS recorded the 1 millionth transplant since record-keeping was started in the late 1980s. This event was then augmented with transplant records for the full year of 2022, resulting in almost 43,000 transplants from more than 21,000 donors, including 15,000 deceased donors and more than 6,400 living donors. There have been year over year increases in deceased donors every year since 2008.
UNOS has been actively implementing new organ distribution programs using the concept of “continuous distribution.” Continuous distribution considers all patient factors together to determine the order of an organ offer, and no single factor will decide an organ match. The goal is to increase fairness. Organs that are now part of the continuous distribution system include lung, kidney and pancreas, and liver and intestine. Heart continuous distribution will start in 2023.
Also, efforts are being targeted to improving organ transportation, which is the physical delivery of organs from donor hospitals to transplant centers.
For more information about any of these topics, please contact the Public Policy Committee, This email address is being protected from spambots. You need JavaScript enabled to view it..
New Criteria for Lung Transplantation take effect March, 2023
UNOS (United Network for Organ Sharing) hosted a webinar on January 19, 2023 to review the plans for the rollout of lung donation continuous distribution for all lung transplant patients.
As a logical next step after removing geographic considerations to the distribution of organs, continuous distribution promotes more equity and access to transplantation for the neediest person on each organ waiting list. In the past, geographic considerations for distribution often meant that a less sick person in a particular region would be offered an organ over someone farther away from the donor hospital who was outside of the fixed geographic distribution area.
Now, there are 9 weighted factors applied to every person on the lung waiting list. These factors create a Lung Allocation Score (LAS). When a lung becomes available, the offer is made to the person with the highest LAS score regardless of geographic location. Geographic location is one of the 9 factors.
UNOS committees are already working on developing continuous distribution allocation factors and weightings for heart, liver, and kidney/pancreas.
For more information about continuous distribution, please check out the following video:
https://unos.org/video-how-continuous-distribution-differs-from-current-system/
https://optn.transplant.hrsa.gov/policies-bylaws/a-closer-look/continuous-distribution/
PASSAGE OF LIVING DONOR SUPPORT ACT IN NEW YORK STATE
December 29, 2022 was a banner day on behalf of organ donation and transplantation in New York State. Governor Kathy Hochul signed into law The New York State Living Donor Support Act (S.1594/A.146A). This law expands the financial provisions and safety features on behalf of individuals who come forward to be living donors.
Elaine Perlman, Executive Director of WaitListZero, provided the following additional information:
“Waitlist Zero's Executive Director Josh Morrison wrote the legislation. State Senator Rivera from The Bronx and Assembly Member Gottfried from Manhattan sponsored the bill.
This spring, a team from the NKDO, NKF, DOVE, LiveOn New York, and Waitlist Zero lobbied for the bill's passage in Albany. Soon after, the LDSA was unanimously passed by both houses. This new law creates the opportunity for New York's living donors to avoid going into debt to donate. Living donors will be reimbursed for their lost wages and out-of-pocket expenses. New York will be the first state in the country to offer this opportunity for donation to be cost neutral for donors.
Currently the Federal Government only reimburses when both the recipient and donor make less than 350% of the poverty line (around $47,000). The LDSA will reimburse the lost wages of donors who make up to $125,000 as well as the costs of donation (travel, childcare, etc). In addition, the LDSA will ensure that all potential recipients will be educated about transplantation.”
For more information about this law, please check out the press release issued by WaitListZero: https://www.willettpublicaffairs.com/post/governor-hochul-signs-new-york-state-living-donor-support-act-into-law
The press release from Governor Hochul’s office can be found at the following link: https://www.governor.ny.gov/news/governor-hochul-signs-new-york-state-living-donor-support-act-law
Part D Protected Classes
TRIO continues to actively participate in the Partnership for Part D Access, which is focused on protecting access to six classes of drugs used to manage complex illnesses, including organ transplantation, that are currently covered under Medicare Part D. This effort is managed by Venn Strategies, a Washington, DC-based government relations public affairs firm.
A resolution to support continued coverage of these drugs was introduced in the last Congress but no vote was taken. The current Congress has been focused on the debt limit and has taken no action at this point. The resolution will be reintroduced in the current Congress by Rep. Grace Napolitano of California. When the new resolution is introduced, there will be social media and organizational outreach efforts to contact members of Congress to support the resolution. The Public Policy committee will provide information about the resolution and key points as this process develops.
UNOS Regional Meetings
Regional meetings are held twice each year during the winter and summer public comment periods. Regional meetings are an opportunity to influence policy proposals, prepare for upcoming changes, and hear perspectives from the transplant community about improvements to organ allocation. There are currently at least twelve proposals open for public comment. Here is a link to those proposals: https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/
The schedule for the Winter Regional meetings for 2023 follows:
- Region 1: March 6, Waltham, MA
- Region 2: Jan. 26, Philadelphia, PA
- Region 3: Feb. 13, Atlanta, GA
- Region 4: Feb. 2, Dallas, TX
- Region 5: Feb. 9, Las Vegas, NV
- Region 6: March 10, Portland, OR
- Region 7: Feb. 7, Chicago, IL
- Region 8: Feb. 28, Kansas City, MO
- Region 9: Feb 14, NYC, NY
- Region 10: Feb. 3, Dayton, OH
- Region 11: March 1, Charlotte, NC
Here is a link to the schedule: https://optn.transplant.hrsa.gov/about/regions/regional-meetings/
Both Chapter leadership and individual members are encouraged to register for their Region’s meetings. UNOS welcomes comments from the recipient community and the Public Policy committee has observed that our comments are definitely heard and considered. Committee members will be attending their Regional meetings and will report on activities.
PUBLIC POLICY REPORT FOR JANUARY, 2023
MEDICARE CHANGES FOR ESRD KIDNEY IMMUNOSUPPRESSIONAfter a years-long grassroots effort, changes to Medicare coverage of immunosuppression for ESRD patients goes into effect January 1, 2023. The coalition of patient advocacy group and organ-related organization such as the NKF carried the fight all the way through the Congress to seeing the White House sign the legislation.
This extension of immunosuppressant drug coverage under Medicare is intended for people who don’t have insurance or who aren’t older than 65 and already receiving Medicare. For an informative video explanation, see https://www.youtube.com/watch?v=0DfihOFKmzc
For all the information about the changes and how patients can start receiving the new benefit, please check out the following website: https://www.cms.gov/medicare/original-medicare-part-and-b-eligibility-and-enrollment/medicare-part-b-immunosuppressive-drug-benefit
If the link doesn’t work, copy and paste the link into a new browser window. You may also call Social Security at 877 465-0355.
PRODUCT EXPIRATION DATESMost of us stay very vigilant about product expiration dates, be it cans or containers of food and certainly our medications. We check to see if a prescription drug or even an over-the counter item has expired beyond its use date.
And we’re all most likely very vigilant about the Covid test kits, to make sure the kit shelf life has not expired so that we feel confident about the results of the test. However, this isn’t the case with the Covid test kits currently available. The kits continue to be available under the FDA Emergency Use Authorization provisions. This means that the FDA is continuously evaluating expiration dates. Companies are still required to issue the test kits with lot numbers and expiration dates; then, the FDA maintains a website that continuously updates expiration dates by lot number. More information about this website can be found at the following: https://www.myast.org/joint-statement-about-covid-19-vaccination-organ-transplant-candidates-and-recipients-0
The statement summarizes the known scientific and medical evidence about vaccine safety and coverage for transplant patients.
WINTER ACHES AND PAINS
It’s difficult to keep track of all the aches and pains that occur when there’s so much going on to make us ill. Northwell Health, a very large hospital system based in Nassau County, New York, has recently published a chart on the various symptoms with COVID, the flu, colds, and RSV (the respiratory virus syndrome). The chart is a very good visual representation of all these diseases and how they manifest themselves. Of course, with all illnesses, please contact your own transplant team for your specific treatment.
The University of Chicago Medicine transplant team performed that health system’s first donated-after-circulatory death (DCD) heart transplant on Nov. 19, 2022. The DCD technique is expected to help heart patients get transplants faster. Donor hearts are traditionally recovered from brain-dead donors, a process known as donation after brain death (DBD). The donor meets the legal definition of brain death but has a beating heart. The organ is recovered while the donor's circulatory system is intact, which preserves the health of the heart.
In a DCD transplant, a patient may still exhibit brain reflexes, but the prognosis is poor – death is imminent. The family may choose to withdraw life support and allow the patient to pass. When the heart stops beating, and a waiting period verifies the heart will not restart, the heart is recovered for donation. The DCD procedure allows the family and registered donors to gift more life-saving organs.
The use of DCD organs is trending in the heart and lung transplant fields, according to Christopher T. Salerno, MD, Director of Adult Cardiac Surgery and the Surgical Director of the Heart Transplant and Mechanical Assist Device Program. UChicago Medicine already performs DCD lung transplants.
Using TransMedics OCS Heart technology, the donor heart is kept in a metabolically active state in a portable unit until it can be transplanted. Advances in technology and recovery procedures have increased the number of DCD organs, according to United Network for Organ Sharing (UNOS). “This technology allows us to get patients transplanted more quickly, saving lives and ensuring better outcomes,” Salerno said. The UChicago Medicine Heart Transplant Program currently has the shortest average wait time for a heart transplant in the country, 0.7 months compared to the national average of 4.9 months. UChicago Medicine is one of just 30 of the 147 U.S. heart transplant centers that performs DCD heart transplants. The increase in DCD donations is expected to provide an additional 600 donors nationally per year, Salerno said. Some reports say it can increase the heart donor pool by as much as 20%.
PUBLIC POLICY COMMITTEE REPORT – DECEMBER 2022 THE ADMINISTRATION FOR STRATEGIC PREPAREDNESS AND RESPONSE (ASPR)
ASPR is a section of the Department of Health and Human Services (HHS). ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. ASPR collaborates with territorial governments, and other partners across the country to improve readiness and response capabilities.
ASPR has been holding regular meetings with its stakeholders during COVID to track the disease as well as the development and availability of treatment, including vaccines, monoclonal antibodies, and anti-virals. At its meeting last week, ASPR published a very useful chart explaining COVID Preventative Agents and Treatments.
Please contact Ike Copperman, This email address is being protected from spambots. You need JavaScript enabled to view it., if you would like a copy of this chart.
WHY YOU MAY SOON HAVE TO PAY FOR THAT COVID 19 TEST
The following information is from the Hill Health Care Newsletter, 11/4/2022.
The federal government is poised to stop paying for COVID-19 vaccines, tests and treatments in the coming months, shifting the costs from taxpayers onto individual patients. Experts say most Americans are not aware that this will happen and will be in for a major case of sticker shock. They warn without additional protections or funding, the transition to commercialized treatments and preventive services will lead to health barriers.
Instead of free access to tests and treatments like Paxlovid, insurance companies and manufacturers will set the price. The days of free, easily accessible COVID-19 tests will also likely end. Private insurance may not cover over-the-counter tests anymore, and patients may need a prescription first for a PCR test.
Vaccines will still be free to people with private insurance, though the cost will likely be reflected in premiums. Even with insurance, patients will likely see costs if they go to an out-of-network provider.
But the biggest impact will be on uninsured or underinsured Americans, many of whom have jobs that put them at greater risk of COVID-19 exposure.
These changes may also be reflective of a broader system: “The way that it works in the U.S. [right now] is actually more similar to how a lot of health care works in other countries too,” said Cynthia Cox, an insurance expert and vice president at the Kaiser Family Foundation. “But when the public health emergency ends, it’s going to start looking like health care in the U.S does, which is that it’s complicated and it costs a lot of money.”
PARTNERSHIP FOR PART D ACCESSTRIO has been a long-time supporter of the Part D coalition to make sure that transplant recipients have access to a specific prescription drug regimen.
Recently, Venn Strategies, the Washington firm leading the efforts of the Part D members in legislative activities, worked with the Congress to issue a non-binding resolution (House Resolution 1390). House member Grace Napolitano from California introduced the resolution in September, 2022. The full text of the resolution can be read at the following site:
https://www.congress.gov/bill/117th-congress/house-resolution/1390In support of this resolution, TRIO members have partnered with Venn Strategies to hold Zoom meetings with their local representatives to tell their stories and ask additional Congressional members to sign on to support the resolution. Rodger Goodacre, Monet Thomson, and Glenda and Ike Copperman continue to participate on Zoom calls in recent weeks talking with representatives from their home states.
UPDATE ON ALL THINGS COVIDDr. Marcus Pereira is an Assistant Clinical Professor of Medicine at the Columbia University College of Physicians. He is also the Medical Director of the Transplant Infectious Disease program at Columbia University Irving Medical Center.
Dr. Pereira participated on a webinar this past week hosted by Jen Benson and Transplant Journey, Inc. Dr. Pereira shared the latest information about all things Covid. These included the current state of vaccines and vaccinations, local infection rates with the latest strains of COVID, and key recommendations for continuing safety and best personal practices for the holidays. COVID is still evolving and changing so it’s going to be with us for a long time.
His presentation was recorded and can be viewed on YouTube: https://youtu.be/IcagY6WWwNI
Dr. Pereira’ recommendations include the following important health and safety measures:
- Continue using masks in the appropriate settings with crowds and places where you don’t know the vaccination status
- Wash hands, wash hands, wash hands
- Use common sense when traveling and be mindful of your surroundings
ESRD TREATMENT CHOICES LEARNING COLLABORATIVE (ETCLC)
The Centers for Medicare & Medicaid Services (CMS) and Health Resources & Services Administration (HRSA) announced that the End Stage Renal Disease Treatment Choices Learning Collaborative (ETCLC) went live on August 20, 2021 under a CMS contract. This work supports the payment model which encourages preventative kidney care, home dialysis, and kidney transplant as well as the broader Advancing American Kidney Health initiative.
The Collaborative will engage transplant centers, Organ Procurement Organizations (OPOs), large donor hospitals, patients, and donor family members to identify highly effective practices currently in use and spread the use of these practices throughout the organ procurement, kidney care, and kidney transplant community. TRIO will be a participating organization in this collaborative. The goal will be to achieve the following three aims:
- - Increase the number of deceased donor kidneys transplanted
- - Decrease the current national discard rate of all procured kidneys
- - Increase the percentage of kidneys recovered for transplant.
Supported by Quality Improvement Coaches, National Faculty, and professional and patient advocacy groups organized into a Leadership Coordinating Council , the Collaborative is expected to enroll 80% of transplant centers and OPOs plus the two largest donor hospitals in each OPO’s donor service area into 25 Teams, which will participate, collaborate, and change practice to meet the three aims of the Collaborative.
PUBLIC POLICY COMMITTEE REPORT - NOVEMBER 2022
THE CONTINUING PROMISE OF MEDICARE’S 6 PROTECTED CLASSES
Medicare’s six-protected classes (6 PC) policy requires that plans cover medications within these six classes, which include: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics.
Since early 2022, the Partnership for Part D access, led by Venn Strategies, has been actively involved with the Congress to continue to demonstrate support for the 6 Protected Classes provision of Medicare Part D.
After identifying a sponsor, Representative Grace Napolitano from California, a bi-partisan group of Congressional members issued a non-binding resolution on September 22, 2022.
You can read more about the resolution at the following link:
https://napolitano.house.gov/sites/napolitano.house.gov/files/wysiwyg_uploaded/NAPOLI020xml.pdf
A press release from Representative Napolitano’s office and a posting from the Part D website are also available:
http://www.partdpartnership.org/newsroom/september-22nd-2022
Following the introduction of the resolution, Venn Strategies set up a series of meetings with congressional members to continue the educational process for 6 PC. Monet Thomson, from the TRIO chapter in San Francisco, and Rodger Goodacre, from the TRIO Board, have participated in these meetings to talk about the protections for the transplant community in the 6 PC provisions.
IMPORTANT NEWS ABOUT FLU AND PNEUMONIA VACCINES
The Centers for Disease Control and Prevention (CDC) has recently published information on the flu and pneumonia vaccines available this season. Flu and pneumonia are expected to be particularly widespread this year. As always, please consult your transplant team for your personal guidance.
There are several flu vaccines available now. Early reports are that they are very effective against the current strains of the flu virus. Of particular interest are new vaccines specifically for people 65 and older. These are vaccines that are known as high-dose quadrivalent because they have 4 times the amount of vaccine per shot. More information can be found at the following CDC website:
https://www.cdc.gov/flu/prevent/qa_fluzone.htm
Also, the CDC has published guidelines for pneumonia vaccinations with specific guidelines for both 65 and older as well as those with underlying medical conditions. This information is at the following CDC website:
https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf
UNOS NEWS
The United Network for Organ Sharing announces that the US reached a historic milestone in 2022: 1 million transplants! In other news, Maureen McBride, Ph.D., has assumed the role of Interim CEO of UNOS. McBride is the first woman and the first person with a Ph.D. to hold this position. Prior to this role, McBride served for 27 years in a variety of senior leadership roles at UNOS, most recently as the Chief Operating Officer. McBride cites patient engagement as a high priority.
COVID NEWS
On October 13, as a result of the continued consequences of the COVID-19 pandemic, Secretary of Health and Human Services Xavier Becerra renewed the public health emergency for 90 days. The first public health emergency declaration was issued January 27, 2020 nationwide. HHS will give the public 60 days notice before lifting the public health emergency, Secretary Becerra said.
The free at-home COVID test program was suspended on September 2, 2022, due to lack of funding from Congress. Here is a link for where to find coronavirus testing:
https://www.hhs.gov/coronavirus/testing/index.html
On an additional organ specific note, the American Association for Liver Disease recently published an article on good Covid-19 resources for liver recipients. That article and be found at https://www.aasld.org/patient-resources
HONOR THE GIFT – CHANGES TO KIDNEY IMMUNOSUPPRESSION COVERAGE IN MEDICARE
The changes in Medicare to remove the 36 month restriction on kidney transplant immunosuppression become effective in January, 2023. The Honor The Gift Coalition began its efforts in 2020 leading to the signing of the bill on December 22, 2020. Along with other groups, TRIO was a participant in the grassroots efforts to bring these changes about for kidney patients.
On Thursday, October 27, CareDX hosted a webinar to review the changes and to help eligible patients apply to Medicare for the change in the coverage policy. Moderated by Alexandra Harrison-Flaxman, Dr. Matthew Cooper from Medstar Georgetown and Troy Zimmerman from the National Kidney Foundation reviewed the history of immunosuppression coverage and then discussed the very important changes available to kidney recipients.
The entire webinar can be seen at the following site:
https://caredx.com/2023-medicare-immunosuppressant-coverage-what-patients-need-to-know/
PUBLIC POLICY REPORT – OCTOBER 2022
The Public Policy Committee opens this month’s report by remembering and honoring Jim Gleason’s lengthy and deep commitment to involving TRIO in the national public policy making process on organ transplant. Your committee promises to continue this support for TRIO to this commitment on the national level and to develop and share resources for the Chapters to help them both better understand and become more actively involved in the policy process on the State level. And as always, the Committee welcomes comments and input on where and how to focus our efforts from the Chapters and individual members.
COVID ISN’T OVER
The Fall and back to school are good times to catch up on what’s happening in the world of COVID recommendations, including the latest in vaccines. The latest in vaccines are booster mRNA vaccines from Moderna and Pfizer. They have the same biochemistry makeup as the original Moderna and Pfizer vaccines; these are vaccines that works without any of the COVID disease incorporated into the vaccine. They are specifically designed to provide immunity from the Omicron variants, so prevalent among the population. These boosters have now been approved and will start to be available throughout September. These boosters can also be given at the same time as the normal flu shot typically available in the fall of every year. There are certain restrictions with each manufacturer’s vaccine; as always, please check in with your transplant team before getting the vaccination.
As always, the CDC, NIH, and FDA continue to maintain outstanding websites and information sources on the latest treatments, vaccines, monoclonal antibodies, and anti-virals. Please check out these sites at the following links:
https://www.cdc.gov/media/releases/2022/p0811-covid-guidance.html
https://www.cdc.gov/coronavirus/2019-ncov/index.html
https://www.covid19treatmentguidelines.nih.gov/tables/mab-characteristics/
https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/
In addition, the American Society of Transplantation also maintains its website with important Covid information, at the following link:
https://www.myast.org/covid-19-information
ELIMINATION OF RACIAL DISPARITIES IN ORGAN, EYE, AND TISSUE DONATION
UNOS continues its efforts and dedication to creating equal opportunity and access to transplantation for everyone who needs the life-saving benefits of organ, eye, and tissue transplantation. These efforts have been included in many committee activities and proposals for changes to all the procedures at OPOs and transplant centers so that the final rule for equitable access is fulfilled.
A major area of interest and study has been the Glomerular Filtration Rate (GFR), a number that is used to establish kidney patients on the transplant waiting list.
The GFR is meant to establish a relationship with the effectiveness of the kidneys to filter creatinine during the natural regeneration of body muscle. When the kidneys are working well, the GFR will be a high number and the creatinine measure will be low. When kidneys don’t work well, breaking down creatinine is much harder; buildup of creatinine in the body can be very harmful.
The GFR is the best tool to measure kidney function and elimination of creatinine. But GFR tests are very complicated and not easily done in a doctor’s office. Therefore, the estimated GFR (eGFR) was created, a mathematical expression of various components of blood work and body type and other factors.
In the late 1990s and early 2000s, several studies were done that established two eGFR mathematical expressions: one if the patient was non-white and the other if the patient was white. It was thought that differences in racial body types, diets, and muscle mass justified the use of two different formulas.
The results of using these two equations was that for a given creatinine number, the non-white eGFR would most likely be lower than the white eGFR. So even though kidney function would be at the same level, the white candidate would be reported out for listing purposes, while the non-white candidate might be deemed not sick enough to report and subsequently list for transplant. Remember that the higher the GFR, the better the kidneys are functioning. And eGFR is used for waiting list priority.
After reviewing this issue, a UNOS report states “Overestimated eGFR values resulting from race adjustments have the potential to delay referral for kidney transplantation and the initiation of qualifying waiting time. Black patients with CKD have worse outcomes and an increased rate of ESRD when compared with other racial groups. They are also less likely to be added to the transplant waiting list and receive a transplant. The use of race adjustments in the calculation of eGFR has the potential to exacerbate existing disparities and negatively impact patient outcomes. Timely assessment and intervention are critical for outcomes of CKD patients, as the disease can progress quickly towards kidney failure. Earlier detection of CKD could improve efforts to prevent progression.”
UNOS has now said that the same GFR calculation must be used for everyone. The result will be that many people who had an eGFR result will now end up with a worse eGFR than was reported for transplant recipient listing purposes. Patients should now require that the accurate, non-race based GFR be reported into UNOS to correct for GFR equality.
You can read more about the efforts at UNOS in the following document from its website:
https://unos.org/voice/achieving-racial-equity-in-transplantation/
There are two additional sites for information about the changes related to eGFR:
https://unos.org/news/implementation-notice-race-neutral-egfr-formulas/
A CONGRESSIONAL RESOLUTION ON BEHALF OF THE 6 PROTECTED CLASSES
Earlier this year, with the guidance of Venn Strategies, the Partnership began working with its Congressional champions to draft a resolution that clearly sets out Congressional support for the Protected Classes provisions of Medicare. TRIO continues as an active participant in the partnership.
Led by Congressional Representative Grace Flores Napolitano, from California, the resolution reaffirms the commitment of the legislative branch to the protections covered by Medicare Part D. Congresswoman Napolitano represents California’s 32nd District. Her Los Angeles County-based district covers several cities and communities in the San Gabriel Valley.
Congress member Napolitano received a great deal of support from the Mental Health and HIV Congressional Caucuses, groups of legislators with shared interests in specific issues.
On Thursday, September 22, 2022, the Part D Coalition announced that the Congress had introduced the resolution. We will have more information about the resolution and any need for grassroots support on its behalf in the upcoming weeks.
CAREDX WEBINAR ON TRANSPLANT IMMUNOSUPPRESSION
CareDX hosted a very good webinar update on transplant medications on September 14, 2022.
Led by Giovanna Codispodo, PharmD, Clinical Pharmacy Manager,
Solid Organ Transplant, New York-Presbyterian Hospital Weill Cornell
Medical Center and Matthew Gillespie, PharmD, Clinical Pharmacist, Kidney and Pancreas Transplant, Comprehensive Transplant Center, Cedars-Sinai Medical Center, the webinar covered the basics of immunosuppression drugs familiar to most recipients and families:
What is immunosuppression and why is it needed
What are some of the increased risks in taking immunosuppression
What are some caveats with immunosuppression and COVID
What are the foods and other substances that should be avoided
What are some suggestions for adhering to a prescription drug schedule
What are some additional suggestions for taking specific immunosuppression medications (e.g., take steroids in the morning)
While our community may feel comfortable with knowing this information, the webinar is a very good refresher. Alexandra Harrison-Flaxman, Community Engagement Manager from CareDX and a kidney recipient as well, provided us with a link to the webinar:
TRIO Public Policy Committee Report - September, 2022
Living Donor Protection Act
TRIO recently signed on along with several dozen other patient organizations to a letter prepared by the Polycystic Kidney Disease Foundation, along with support from the National Kidney Foundation, in support of federal legislation for the Living Donor Protection Act. This letter is addressed to the Chairs and Ranking Members of the House Energy and Commerce Committee and Health Subcommittee, urging them to prioritize the passage of the Living Donor Protection Act.
We have previously reported on recently passed New York state legislation to protect living donors which could very well provide model legislation for other States to consider. As previously reported at this point the bill has been passed by both houses of the New York State legislature but has not yet been signed into law as the Governor’s sign off remains pending. We will continue to follow the progress of the bill and provide updates.
UNOS Regional Meetings
The UNOS Summer meeting schedule remains underway. During the last month committee members attended the Region 2, 4, 5 and 9 meetings.
Below is a sample report on the Region 5 meeting prepared by Monet Thomson who is a public policy committee member:
The United Network for Organ Sharing meeting took place August 25 in Las Vegas and online. There were several presenters. The first topic of conversation was expediting organ placement. UNOS is discussing eliminating a transplant center's “provisional yes” to an organ offer. UNOS is working on “offer filters” so the decisions are faster. There is a learning curve on the program, so one participant mentioned that they have to allow for “exceptions to the rule.”
The next topic of discussion was continuous distribution of organs, which prioritizes transplant patients in a more flexible manner, not just by where they live. Here are some of the highest priorities: most difficult to match, pediatric candidate, a prior living donor, and waiting list time. If you would like a say in organ distribution policy, the comment period for this ends Sept 28. Here is a link where you can comment:
https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/
In addition, one attendee mentioned that UNOS would like to include transplant patients on the OPTN policy development committee. (Recently, 880 people volunteered for 130 committee vacancies, which is unusual and great for any organization.)
UNOS Regions: A survey showed that there was no agreement on how to redistribute the eleven regions across the country, so for now they will stay the same.
Race-inclusive eGFR calculation: Waiting time will be restored to registered Black kidney candidates whose waiting time was affected by race-inclusive eGFR calculations, and who meet documentation and timeframe criteria. A survey showed strong support by the participants and there wasn’t much discussion about it.
Brian Shepard, OPTN Executive Director, will be retiring next month. He said the one millionth transplant in the US is coming soon! He mentioned a recent Senate Finance Committee hearing that was critical of UNOS’s IT services, but he said the system has 99.9% up time. He said the biggest challenge to equity for potential recipients is getting to the waiting list in the first place. On Oct 1, Maureen McBride, PhD will become interim director. A participant at the meeting spoke of the “shameful, orchestrated and unbalanced" Senate Finance Committee meeting. Another mentioned there’s no other system in the world that has saved so many lives and is a model for other countries.
A couple of areas of need for hospital MDs: 1) referring nephrologists sometimes need to be in touch with kidney transplant programs earlier, 2) OPOs (Organ Procurement Organizations) need to be involved much earlier in DCD cases. DCD acceptance in the US isn’t as much as in Spain and some other countries. A donor after circulatory death (DCD) is typically a donor who in the face of a devastating, irreversible neurological injury elects withdrawal of ventilator and other life support; they do not meet brain death criteria until they die from circulatory collapse after withdrawal of life support.
The public comment period for proposals discussed at these meetings remains open through September 28. These meetings are open to the public additional information about the meetings please check https://unos.org/community/regions/regional-meetings/
There are several more Regional Meetings scheduled for September:
Region 6, Seattle WA, September 9
Region 7, Chicago IL, September 1
Region 8, Kansas City MO, September 12
Region 10, Toledo OH, September 20
Region 11, Charlotte NC, September 22
Inflation Reduction Act Changes and Health Care Costs
As part of a long-standing effort to expand health care access across the country, Democrats included a three-year extension of expanded health care subsidies first approved last year as part of the $1.9 trillion pandemic aid law. The bill would also give seniors access to free vaccines,allow Medicare to negotiate the cost of up to 10 prescription drugs initially, beginning in 2026, and cap annual out-of-pocket drug costs for Medicare recipients at $2,000. It would also cap insulin costs at $35 per month for enrollees.A helpful explanation of the health benefits can be found on the Kaiser Health information site:
Early Results of New UNOS Kidney Allocation Protocols
The UNOS Kidney Transplantation Committee recently published a report summarizing the results from the changes to kidney allocation introduced in 2021.
The report detailed the results covering the timeframe from March 15, 2020 through March 14, 2022.
Median transport distances increased from 68 to 121 nautical miles.
Cold ischemic time increased from 17 to 19 hours.
There was a slight increase to the start of new kidney functioning, from 29% to 31%.
The transplant results were extremely important:
Overall there were 16% more transplants:63% more pediatric transplants
23% more transplants in the Black community
29% more in the Hispanic community
20% more in the Asian community
78% more in the very hard to transplant high CPRA category
36% more to waiting list candidates with 3+ years of dialysis
These results are very much in line with projections made through modeling efforts done before the allocation algorithms were changed.
UNOS Report of Liver Allocation Changes
Similar to the results from changes to kidney allocation, UNOS also published a study on the results for transplantation as a result of new liver allocation algorithms. The report showed positive changes in liver transplants since these new policies went into effect:
- Liver only transplants from deceased donors increased more than 5%
- There were almost 100 more liver-kidney transplants
- Candidates with MELD or PELD scores greater than 29 were also transplanted more often
- Also similar to kidney results, cold ischemic time increased slightly and transplantation distances from donor hospital to transplant center increased, as a result of moving organs to the sickest patients.
UNOS and Organ Allocation Studies
Much has been published recently on the shortcomings of the organ allocation system and substantial reforms which may need to be undertaken . The Senate Finance Committee recently held hearings on the OPO system and several other internal governmental studies have been conducted. TRIO of course supports those reforms necessary to make the system efficient, fair and equitable and that is an evolving situation. A good straightforward description of the situation can be found in a recently published Washington Post article. The link to this article can be found at https://www.washingtonpost.com/health/2022/07/31/unos-transplants-kindeys-hearts-technology/
UNOS Proposed Changes to Modify Waiting Times under New EGFR Rules
In June of this year, the UNOS board adopted a proposal intended to make the EGFR (Estimated Glomerular Filtration Rate) calculation race neutral in kidney allocation. At all of the recent UNOS Regional meetings vigorous discussions have taken place around a subsequent proposal intended to modify waiting list times for individuals who had been affected prior to the adoption of these new rules. Discussion focused on making the new rules known to minority communities and enforcing adherence to them by transplant programs and hospitals. Lorrinda Davis, a committee member and the incoming TRIO president, submitted comments to UNOS on the best approach to implement these new rules. Her comments can be found on the UNOS website at
TRIO Public Policy Committee Report – August, 2022
FDA APPROVAL OF PIG HEART TRANSPLANTATION RESEARCH
Xenotransplantation, using non-human organs for human transplant, continues to make strides toward approval as a transplant treatment. The Federal Drug Administration (FDA) has recently moved forward to approve testing efforts at several additional transplant centers.
NYU-Langone recently reached a milestone with its xenotransplantation efforts, performing two pig heart transplants. Here’s a link to the story on the efforts at NYU:
https://www.cnn.com/2022/07/12/health/pig-heart-transplant-nyu/index.html
For more information, check out the following articles:
https://www.nature.com/articles/d41586-022-01861-2
IS IT A COLD, THE FLU, ALLERGIES, OR COVID?
Fall and winter are going to be here before long, and it’s more important than ever to know the differences in the various afflictions that can bring misery to us during the winter months. There are several good charts that compare the symptoms of these diseases, along with information about the treatment options that should be employed.
Here is a pointer to an excellent article from the Mayo Clinic:
HAVE YOUR PRESCRIPTION DRUGS EXPIRED?
Do you read your prescription drug labels and ask yourself about expiration dates or use by dates? Here’s a helpful link:
https://www.health.harvard.edu/staying-healthy/drug-expiration-dates-do-they-mean-anything
Melinda Wenner Moyer, the prolific science writer for The New York Times, has also written an article that helps explain how drugs work and the true meaning of expiration dates. The article is dated July 7, 2022. (Note: this link might require a subscription to The New York Times e-version):
https://www.nytimes.com/2022/07/07/well/live/expired-medicine.html
COVID TREATMENT BEBTOLIVIMAB
There is a new COVID treatment drug available which may be particularly effective against omicron variants. The drug is called bebtolivimab. Research is ongoing on its use and Eli Lilly, the manufacturer, is working with the federal government on this research. The availability of the drug and payment for it by insurance companies and the federal government under Medicare and Medicaid is not fully established at this point. In any case, transplant recipients should as always check with their transplant team before using any new drug, especially those which may be prescribed by practitioners outside of the transplant system.
Here is a recent article from The Lancet that calls for wider access to this monoclonal antibody, which treats patients who already have COVID.
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00495-9/fulltext
Here’s a release from the manufacturer:
TRIO will continue to follow up and report on developments on the availability of bebtolivimab, its use for transplant patients, and the resources for payment for its use.
PART D SUPPORT FOR IMMUNOSUPPRESSANTS
TRIO continues to actively participate in the Part D Coalition whose mission is to continue the legislative support for the six protected classes of drugs under Part D, which includes immunosuppressant drugs. Venn Strategies, which is the organizational lead for this effort, recently released a proposed resolution to be circulated to Congressional offices to gain support for this effort.
TRIO has carefully reviewed this document and made several suggested changes to the language on protection for immunosuppressant drugs to make this section as strong as possible by emphasizing (1) that there is the potential for loss of the transplanted organ and possible loss of life if the drug regimen is in any way compromised, and (2) that transplant recipients often have co-morbidities that require consistent treatment from month to month. TRIO will continue to participate in the coalition and continue to report on any developments.
ELIMINATION OF RACIAL DISPARITIES IN TRANSPLANTATION
The United Network for Organ Sharing (UNOS) continues its efforts and dedication to creating equal opportunity and access to transplantation for everyone who needs the life-saving benefits of organ, eye, and tissue transplantation.
These efforts have been included in many committee activities and proposals for changes to all the procedures at Organ Procurement Organizations (OPOs) and transplant centers so that the final rule for equitable access is fulfilled. You can read more about the efforts at UNOS in the following document from its website:
https://unos.org/voice/achieving-racial-equity-in-transplantation/
UNOS REGIONAL MEETING SCHEDULE
As noted in our June report, UNOS has regional meetings twice a year in the summer and winter. Here’s a list of the August and September meetings:
Region 1: Aug. 29 – Worcester, MA
Region 2: Aug. 16 – Newark, NJ
Region 3: Aug. 31 – Atlanta, GA
Region 4: Aug. 11 – Oklahoma City, OK
Region 5: Aug. 25 – Las Vegas, NV
Region 6: Sept. 9 – Seattle, WA
Region 7: Sept. 1 – Chicago, IL
Region 8: Sept. 12 – Kansas City, MO
Region 9: Aug. 18 – New York, NY
Region 10: Sept. 20 – Toledo, OH
Region 11: Sept. 22 – Charlotte, NC
Here’s a link to more information about the UNOS regional meetings:
https://unos.org/community/regions/regional-meetings/
The regional meetings are typically offered in both in-person and virtual formats and are open to all people with an interest in transplantation. The Public Policy Committee members will be attending their regional meetings, and all TRIO members are encouraged to review the agenda and possibly attend their regional meeting.
New York State Legislature Passes Living Donor Support Act (S1594/A146A)
As mentioned in our July report, after receiving unanimous support from the New York State Senate, the New York State Assembly passed the Living Donor Support Act in June, 2022. The bill would reimburse kidney donors for non-medical costs associated with surgery such
as wage reimbursement; the median costs for a living donor can be as high as $4,000.
If it increases living donations in New York by 20%, similar to a law passed in New Zealand,
it could result in more than 100 additional transplants per year. The bill is now scheduled to
be sent to the governor later this year for signature.
It is hoped that this law will serve as a template for living donor actions in other states and we will continue to report on developments especially as they may relate to other states and the federal government.
SCIENTIFIC REGISTRY OF TRANSPLANT RECIPIENTS (SRTR)
The SRTR is charged with developing information about the transplant system and providing it to Congress and the public. SRTR recently held a conference on July 18 – 20 to get recommendations from stakeholders for better metrics to support both transplantation and donation. The goal is to ensure that patients, families and health care providers have access to statistics and reporting that can help them make the best informed decisions. Lorrinda Davis, President of TRIO Oklahoma and a member of the TRIO National Board, attended the conference and provided valuable information and suggestions for metrics and reporting from the patient perspective on both pre- and post-transplant matters. Further discussion of all of the information that she provided at the conference and progress being made by the SRTR in adapting and working with the input and suggestions provided by all stakeholders particularly those from the patient perspective will be included in upcoming public policy committee reports.
TRIO Public Policy Committee Report – July, 2022
UNOS PUBLIC COMMENTS
After UNOS (www.unos.org) publishes its proposals for change and asks for public comment, the public comment period is closed and the UNOS committees evaluate the comments. If necessary, proposals are modified and reissued for more public comment. Currently, TRIO is monitoring the UNOS website for any new or changed proposals that were announced by UNOS in late 2021.
In particular, TRIO has been focusing on racial equality proposals in organ transplant policies. At its next in-person meeting this month, the Board of Directors of the Organ Procurement and Transplantation Network (OPTN) will consider a proposal to require transplant hospitals to use race-neutral calculations when estimating a patient’s glomerular filtration rates (GFR). This proposed change aims to reduce health disparities and address inequities for Black kidney candidates by more accurately estimating their GFR values. Details about the proposal can be found at the highlighted website.
THE SCIENTIFIC REGISTRY OF TRANSPLANT RECIPIENTS (SRTR)
SRTR (www.srtr.org) was created in 1984 at the same time as the transplant distribution system, called the Organ Procurement and Transplantation Network (OPTN. www.optn.hrsa.transplant.gov) ), was created in the United States. SRTR keeps track of every transplant for every organ at every Organ Procurement Organization (OPO) and transplant center in the US and provides this data to evaluate transplant performance.
In recent years, SRTR has implemented changes to its data availability to make it more accessible to the public. This is through a program called the Task 5 Initiative. SRTR has convened a public meeting for July, 2022, to discuss future plans for additional changes. Lorrinda Davis, President of TRIO Oklahoma and member of the TRIO National Board of Directors, will be representing TRIO and transplant patients at that July meeting. TRIO will continue to follow activities with SRTR and report back to our members.
PAXLOVID UPDATE
There are many effective treatments in this COVID world for transplant recipients. There are prophylactic treatments given to recipients when antibody production hasn’t been effective through vaccinations. If a recipient gets COVID, there are monoclonal antibody and anti-viral treatments that are also very effective as long as treatment begins at the first sign of symptoms.
As reported in our last report and TRIO Newsletter transplant recipients should avoid the use of Paxlovid. Recent reports continue to confirm that transplant recipients should not use PAXLOVID for COVID treatment. PAXLOVID has been shown to reduce immunosuppression coverage regardless of the solid organ transplant type.
As always, transplant recipients should consult with their transplant team for COVID treatment options.
THE LIVING DONOR SUPPORT ACT (LDSA)
New York State has been in the forefront of considering ideas to encourage living organ donation. In some cases, there is a donor, but financial disincentive, such as lost wages or travel costs or even loss of health insurance, stand in the way of the ability of a person to actually donate. Last month, the New York State Legislature passed the LDSA and has sent this bill onto the Governor for her signature. The hope is that this New York State bill will serve as a blueprint for other states to adopt on behalf of living donation.
THE PART D COALITION
TRIO continues to participate in monthly meetings with the Part D Coalition to keep its members aware of activities that may impact access to prescription drugs such as immunosuppression. In the past, grassroots activities have resulted in keeping open access to prescription drugs. Committee members continue to participate in monthly Part D Coalition activities.
Recently, the Medicare Payment Advisory Commission (MedPac), an independent, bi-partisan legislative agency, distributed a package of recommendations to CMS. Venn Strategies, the lobbying group that guides Part D activities, is evaluating this package and will keep the Coalition informed about potential pricing ideas that could negatively impact our members.
XENOTRANSPLANTATION UPDATE
Several Committee members recently attended a webinar of xenotransplantation and gene editing presented by TRIO Maryland. That webinar can now be found on Youtube at hps://www.youtube.com/watch?v=U1unvxEwsg4
The presenter laid out all of the steps that need to be taken in gene editing to place human genomes into pig cells while preventing acute rejection and removing other pig genomes which could create retro-viruses in humans. The cells are then placed in the egg of the female pig and that could become the source for a transplantable organ into humans. Presently the research is being done on transferring organs from pigs to monkeys and some studies of transplanting organs to brain dead humans have also been undertaken. Kidneys and hearts are focus of current studies with lungs and livers somewhat further in the future. Hearts are likely to be at the head of the list as heart transplants are typically more emergent. The current thinking is that the FDA may be in a position to authorize the start of studies in humans in 2023 or 2024 again with hearts likely to be the first organ to be studied.
MEDICARE AND ORGAN ACQUISITION PAYMENT
The Centers for Medicare & Medicaid Services (CMS) recently published and requested comment for its proposed rule for Inpatient Prospective Payment Services (IPPS) for Fiscal Year 2023. TRIO did not offer any comments as explained below.
As general background, Medicare reimburses hospitals for organ acquisition costs, the transplant surgery, in patient and post-transplant costs; and that reimbursement comes through different payment methodologies: -Medicare Part A pays for inpatient hospital costs and certain follow-up care through the IPPS which uses diagnoses codes to make a fixed payment to hospitals for these services. -Medicare Part A pays for organ acquisition costs under a reasonable cost system which takes into consideration many factors. -Medicare Part B generally pays for physician and other services related to the transplant procedure itself.
In the proposed and final rule for the previous fiscal year FY2022 CMS had considered codifying and compiling a number of policies regarding the counting and reporting for hospitals and hospital organ procurement organizations of Medicare usable organs and total usable organs. For this year FY2023, CMS made no proposals to change organ acquisition payment policy and will continue to pay these acquisition costs on a reasonable cost basis. TRIO made no comment on that decision as any changes that CMS would have made as earlier proposed would likely have reduced the amount of payment to hospitals for these services and TRIO found that the CMS decision to continue the current payment system would likely best serve the needs of transplant patients.
TRIO Public Policy Committee Report – June, 2022
UNOS Regional Meetings
UNOS organizes Regional Meetings twice each year – a summer and winter meeting. UNOS recently released the summer meeting scheduled for this year. That schedule along with other information about attending those meetings can be found at https://unos.org/community/regions/regional-meetings/. Committee members will attend their Regional Meetings and encourage everyone who has the opportunity to attend their Regional Meeting. Here is a quick list of the places and times for the meetings:
• Region 1: Aug. 29 – Worcester, MA
• Region 2: Aug. 16 – Newark, NJ
• Region 3: Aug. 31 – Atlanta, GA
• Region 4: Aug. 11 – Oklahoma City, OK
• Region 5: Aug. 25 – Las Vegas, NV
• Region 6: Sept. 9 – Seattle, WA
• Region 7: Sept. 1 – Chicago, IL
• Region 8: Sept. 12 – Kansas City, MO
• Region 9: Aug. 18 – New York, NY
• Region 10: Sept. 20 – Toledo, OH
• Region 11: Sept. 22 – Charlotte, NC
UNOS Public Comment
As noted in previous reports the public comments for fourteen recent proposals recently closed and UNOS has taken no public action so far. We will continue to monitor and report on the status of those proposals along with sixteen other proposals that also remain under UNOS committee review. The public comment period for all thirty of the proposals is closed at this point and further information about those proposals can be found at https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/.
Part D
The committee continues to actively participate in the Part D Coalition to continue the six protected classes of drugs. Venn Strategies, the Coalition leader, reported out at last week’s call that there’s very little activity going on in the Part D space right now. There may be a congressional resolution coming in June from one or more of the donation-related congressional caucus groups. If such a resolution issued TRIO will review and actively participate in any subsequent activities, including Congressional office visits, to support the resolution. TRIO has participated in such visits in the past and found them to be very useful in promoting Congressional understanding of the circumstances and needs of the transplant community.
LIVING Donor Protection Proposals
HR1255, The Living Donor Protection Act introduced in the House in 2021 by Representative Nadler, is still being considered in House committees. Senator Kristin Gillibrand introduced the Senate version of this Act, S377, in February, 2021, and this bill is now in the Health, Education, Labor, and Pensions Committee.
In a parallel effort, a living donor act is making its way in New York State. The New York State Senate passed S1594, and there is a very strong grassroots effort going on to pass New York State Assembly Bill A146A before the legislative session ends in June, 2022.
Paxlovid Use Update
While not directly policy related the Committee wants to pass along information which recently came to its attention that was sent out by Johns Hopkins to the transplant patient community regarding treatment if diagnosed with Covid. The Committee believes this is important information to know and as always you should be sure to discuss your personal situation with your own transplant team:
“There is an oral anti-viral medication called Paxlovid on the market but this medication is NOT FOR TRANSPLANT RECIPIENTS. THIS MEDICATION HAS A SEVERE INTERACTION WITH TACROLIMUS AND CYCLOSPORINE SO YOU SHOULD NOT TAKE IT. The Paxlovid causes the levels of your medication to rise to very high levels and has caused renal failure and severe neurological side effects in transplant recipients who have taken it. Remember you should always contact the transplant office to discuss any new medication to check for interactions that may not be well known to outside providers.”
IPPS Comments
The Centers for Medicare and Medicaid Services (CMS) recently published its annual update to the Inpatient Prospective Payment System (IPPS) which updates the rule for Medicare payments to inpatient hospitals. The Public Policy Committee will be reviewing these new rules for any changes which may have particular significance for transplant patients. Comments are due in June and the Committee will report on those findings and any comments in the report for next month.
TRIO Sign on to Patient Community Letters
In earlier reports it was noted that TRIO sign on in support of two Patient Community Letters was under active consideration and TRIO has now signed on to those letters. The first was an FTC request to limit the reach of Pharmacy Benefit Managers in controlling patient access to drugs. The second letter focused on including mental health in the drugs in the Safe Steps Act again with the goal of increasing patient access to needed drugs on a timely basis. Access to copies of the final signed documents will be reported as soon as they are available.
TRIO Public Policy Committee Report – May, 2022
FEDERAL TRADE COMMISSION REQUEST FOR COMMENT ON PHARMACY BENEFIT MANAGERS
Recently, the Federal Trade Commission (FTC) asked for public comment on the impact of Pharmacy Benefit Managers (PBMs) on the consumer and prescription medications. The Autoimmune Association and the HIV+Hepatitis Policy Institute drafted a letter in response to this request and circulated the letter to other patient-centered groups, such as TRIO. The letter pointed out the policies and practices of PBMs that control access to medications, limit choices that consumers have in their drug plans, and increase co-operation between insurers and PBMs that add burdens to patients and the medical community. The letter called on the FTC to improve and increase its oversight “to more effectively regulate how PBMs operate within the health care system”. The TRIO Public Policy Committee has recommended that TRIO join other patient organizations in support of this approach and TRIO has added its name to the list of signatories for the letter.
THE PARTNERSHIP FOR PART D ACCCESS
TRIO continues to take an active interest in participating in the activities of the Partnership for Part D Access, the coalition committed to maintaining the 6 Protected Classes (6PC) provisions under Medicare. These provisions allow covered patients unfettered access to prescription drug programs as written by medical practitioners and not as dictated by insurance drug plans or pharmacy benefit managers.
In a recent call, the staff at Venn Strategies, the Washington group hired by the Partnership coalition, reviewed activities in the Congress and the Executive branch. Venn continues to reach out to congressional champions to develop strategies to maintain the 6PC and TRIO remains committed to participating in those efforts.
SAFE STEP ACT
House (HR 2163) and Senate (S 464) versions of the Safe Step Act were introduced in the Congressional 2021-2022 term in early 2021. There are now more than 30 Senate co-signers and more than 110 House co-signers. Step therapy is a tool utilized by insurance plans and sponsors that requires patients to “fail first” on an insurer preferred medication before they can receive coverage for the medication prescribed for them by their medical team. While transplant patients already have many of the protections from step therapy through Part D, TRIO supports the protection generally and wishes to show its support for the broader patient community.
The Safe Step Act would accomplish the following:
Ensure employer plans offer a clear step therapy exceptions request process;
Outline circumstances in which a step therapy exceptions request should be granted;
Require employer plans to respond to a step therapy exception request in less than 3 days.
There is a more detailed description of the benefits of the Safe Step Act that can be read at the following website: https://cdn.ymaws.com/www.ascp.com/resource/resmgr/docs/advocacy/safestepactfinal.pdf Now, the broad-based coalition of grassroots organizations that are lobbying to enact the Safe Step Act into law has begun a coordinated social media campaign. There is a SSA Social Media Thank You Guide to continue to grow the congressional commitment to passing the Safe Step Act in 2022.
UNOS PUBLIC COMMENTS
As noted in earlier Monthly Reports, UNOS introduced a wide range of proposals in Fall, 2021 that called for public comment. The full list of those proposals can be found at the UNOS website: https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/ The public comment period is now closed. All the appropriate UNOS committees are now reviewing the public comments. Then, the proposals could be moved forward for UNOS Board consideration or the proposal could be re-written or modified and re-introduced for more public comments. The TRIO Public Policy Committee will continue to actively monitor this process and report on any changes and developments.
TRIO Public Policy Committee Report – April, 2022
THE LATEST COVID INFORMATION
Members of TRIO recently sat in on a webinar on March 11 hosted by Transplant Journey, Inc. (TJI). TJI is an organization started by Jen Benson, who received a simultaneous kidney-pancreas transplant more than 5 years ago. TJI provides access to one-on-one support and mentoring from individuals who have been on the transplant path.
TJI presented Dr. Marcus Pereira, the Medical Director for the Transplant Infectious Disease Program at the NYP-Columbia transplant program. Dr. Pereira’s information-packed webinar is now available on YouTube, at the following link: https://www.youtube.com/channel/UCX48VaE-ILDqwxt-Ktpget Dr. Pereira provided some particularly important information on the timing of vaccinations and Evusheld, the new pre-exposure prophylactic treatment for transplant recipients. He summarized this as follows:
> Is it ok to get a vaccine after COVID-19? If so, when? • Yes it is ok. Per CDC, no need to wait 14 days. Just wait until recovered.
> Is it ok to get Evusheld after COVID-19? If so, when? • Yes it is ok. No need to wait.
> After Evusheld, is it ok to get a vaccine? If so, when? • Yes, it is ok. Per CDC, no need to wait.
> After getting the vaccine, is it ok to get Evusheld? If so, when? • Yes, it is ok. Per FDA, wait 14 days.
Information on COVID-19 is constantly being updated by government agencies, transplant centers, pharmaceutical companies, and professional medical organizations. Please make sure you’re keeping up-to-date with this information. As always, please consult your transplant team before any vaccine or prophylactic treatment.
PART D COALITION
TRIO continues to actively participate in the Part D Coalition to support the six protected classes of drugs which includes immunosuppressives. The Coalition is currently considering how best to work with Congressional staff on a proposal for a Congressional Resolution in support of Part D and the protected classes. At this point, there is no active discussion or consideration in the Congress or the Administration of any changes to the protected classes nor does there appear to be any movement in that direction in the near future. Updates will be provided in future reports as the determination on action on the Resolution proceeds.
FRIENDS of HRSA
TRIO is a participant in a group of organizations called the Friends of HRSA. HRSA or the Health Services Resource Administration is an Agency with Department of Health and Human Services which has the responsibility for administration and funding for the United Network for Organ Sharing (UNOS). The Friends of HRSA recently developed a letter which supported the full funding of the HRSA and TRIO has signed on in support of that funding. Such full funding will clearly help reach UNOS better administer and support the transplant community.
UNOS REGIONAL MEETINGS AND COMMENTS ON POLICY PROPOSALS
UNOS has two sets of annual regional meetings – a winter and summer session each year. The winter regional meetings have now been completed and Committee members attended various meetings virtually around the country. The summer schedule for meetings has not yet been released and the committee will share that information as soon as it is available.
As discussed in previous reports UNOS had fourteen (14) proposals out for public comment which ended on March 23 and is now closed. Information about the proposals and those comments can be found at https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/ The public policy committee will continue to actively follow this policy development process and report on UNOS actions as updates become available.
SAFE STEPS ACT
TRIO has signed on to a letter in support of the Safe Steps Act. This Act would limit the use of step therapy in many circumstances and allow patients better and quicker access to prescription drugs that work for them without the need for step therapy or the use of drugs other than the one prescribed for them individually. Even though we as transplant recipients enjoy many of these protections under Part D, TRIO determined that this protection should be available for all patients and wanted to show its support for the needs of the patient community more broadly by signing on to the letter. No action has been taken on the Act and the public policy committee will continue to report on and monitor the status of any legislation that moves forward.
XENOTRANSPANTATION
Members of the Public Policy committee sat in on a recent webinar sponsored by CareDx on xenotransplantation. The webinar was highly technical in nature and focused on genetic and other challenges that will need to be resolved to make xenotransplantation using the animal organs successful. The webinar also discussed a number of bioengineering developments and the ongoing efforts in the area of the artificially created organs. Jim Gleason, TRIO’s president, very ably represented the patient community perspective during the webinar. The major takeaway of course is that as these developments progress the future could hold major changes in the organ transplant process and in fact an entirely different system of transplantation would be created. TRIO will continue to follow CareDx activities in this area.
TRIO Public Policy Committee report for March 2022
UNOS Policy Proposals
UNOS currently has fourteen (14) policies available for public comment and that public comment period is open through March 23. A complete list of those fourteen policies and the method for comment can be found at . Five of the meetings will take place in March and information about those which have already occurred is available on their individual Regional websites. More information about these proposals will also be available at the UNOS Regional winter meetings. The schedule for those meetings is available at https://unos.org/community/regions/regional-meetings/. Five of the meetings will take place in March and information about those which have already occurred is available on their individual Regional websites.
All individual members and chapters can comment on any proposal and TRIO National is considering submitting comments on several including the redesign of the Regional Map and the Continuous Distribution of Kidneys and Pancreata. Others under consideration for comment include Improving Liver Allocation, Living Donor Exclusion Criteria, and Safety Net for Heart-Kidney and Lung-Kidney Allocation. Additional information will be available on actions taken in the April Report.
Johns Hopkins Observational Study on Covid Vaccines
Johns Hopkins has been conducting a general observational study of response to Covid vaccines by the immunosuppressed transplant populations and a committee member has been a participant in that study. The study continues and a general update was provided to participants and a number of highlights from that review follow
: -Overall Response Rate – Approximately 1/3 of patients did not significantly respond to initial vaccines especially those with who have high immunosuppression including Mycophenolate Mofetil (Cellcept). The preliminary study appears to show those taking over 1000mg of Mychophenolate daily have a significantly lesser chance of developing anitbodies. Belatacept also clearly does not allow for a good response rate to vaccines with a 5% response rate after two vaccines and a 36 % rate after 3 vaccines doses.
-Fourth Dose. The fourth dose should be taken at least 3 months after the third dose. The fourth dose appears to be very useful and has raised the antibody response rate even in those with poor responses to the initial doses.
-Fifth Dose. Only a very small sample is available at this point and antibodies levels have increased for participants after the dose. Side effects seem to be mild and the same as experienced for earlier doses with no safety issues so far. However, it must be emphasized that the study sample is small and no conclusions or recommendations are made at this point.
-Other Studies. Several further studies are in progress including: (1) how Mycophenolate effects the B Cell and T Cell Response to the Vaccine; (2) how effective is Evusheld as a preexposure treatment for transplant patients including how well patients respond, how safe is the treatment, how durable is the treatments, and how response to variants is affected; (3) how antibody level response and transplant patient experience has been with an Omicron breakthrough.
-General Overview. One should not assume immunity even if antibody test levels are high. Antibody levels are a continuum and no particular level should be viewed as providing a particular level or protection of immunity. Further given the variant climate conclusions about the effect of particular levels is even more problematic.
All transplant patients should continue to practice all of the general safety measures including masking and social distancing regardless of any changes in the laws or policies governing these matters. CDC guidelines are helpful but all recipients should continue to consult with their transplant team.
TRIO Public Policy Committee report for February 2022
An Interesting Medication Purchase Strategy
It’s the beginning of the year and new deductibles are now here. Many pre- and post-transplant recipients go through obstacles obtaining medication at an affordable cost. There are, of course, many resources for medication – GoodRx, copay cards, and patient assistant programs.
Did you know that, when filling your prescription, you can ask what the cash price of the prescription would be? This may allow you to pay your deductible at a lower cost over a couple of months rather than taking such a big hit for needed medication in the first couple of months of the year. As an example, one of our Public Policy members went to fill a prescription for a medication for which the out of pocket cost with insurance was $84.00 but, when asked, the pharmacist said that the cash price was actually only $20.00. The person then decided to pay the $20.00 and thus put off the other $64.00 to be paid toward the deductible until later.
Shortly thereafter that same member learned that a prescription for Mycophenolate was ready and that the price was going to be $264.00. The pharmacist indicated that in this case the cash price was $129.00 which was again significantly less than the insurance level pricing. This provided another opportunity to pay the deductible more slowly over a several month period. This strategy may be helpful, especially with lower cost medications. The amount for the deductible does not change and one’s out of pocket expenditure will ultimately be the same, but this strategy does allow for a longer-term payment of that deductible. And finally, it may help the user put off the arrival of the Part D donut hole until later in the calendar year than it would have otherwise come if the deductible had been fully paid earlier in the year.
While everyone’s financial planning, insurance coverage, and tolerance for deductible payments is particular to them, this may be an approach to consider, especially now at the beginning of the year when deductibles do have to be considered and met.
Covid Update
The Public Policy Committee has been following numerous webinars and presentations on Covid prevention strategies and found one recently made by the Northwestern Medicine Organ Transplant Center to be particularly helpful and useful to transplant recipients. Of course, any decision you make about your own care should be discussed with your transplant team before you take any action and all of the general precautions such as masking and social distancing should continue to be practiced.
While the United States is almost completely exposed to Covid and the Omicron variant, the transplant team from Northwestern Medicine Organ Transplant Center pointed out that there are still actions you can take to protect yourself from Covid even if you come down with an infection. Being vaccinated goes a long way to protecting you from hospital stays and even serious consequences. The data overwhelmingly supports these conclusions. Northwestern is now recommending that all transplant recipients seek out the fourth dose approximately five months after receiving the original program of 3 doses of Moderna or Pfizer mRNA vaccines. The fourth dose completes what the FDA is now calling “up to date” rather than “fully vaccinated.” If you can receive the fourth vaccine from the same mRNA manufacturer as the first three, that is preferable, but transplant recipients should take whatever mRNA vaccine is available.
The newly announced Evusheld monoclonal antibody treatment promises good coverage for recipients, but it is in very short supply to hospitals right now. The transplant unit at Northwestern is prioritizing the supply they have to its post-transplant recipient list. Even if you receive Evusheld, you should still get the fourth booster dose 90 days after your Evusheld treatment. Paxlovid, on the other hand, is not recommended by Northwestern for transplant recipients.
Please remember that caregivers and family need to be “up to date” with the vaccination regimen as well. Beyond these recommendations, Northwestern is still telling its patients to continue following the social protocols from the past two years: a good mask, social distancing, and avoiding indoor spaces and crowds where the vaccination status of everyone is not known. The masks should be N95, KN95, or KF95. There is a good website to make sure you’re getting the best product from a trusted site: https://shop.projectn95.org/masks
In addition, the New York Times recently ran a story on how to make sure you’re getting the right mask: https://www.nytimes.com/article/covid-masks.html
CMS Request for Information
In the December 2021 Public Policy Report, we shared information on a recently published CMS (Centers for Medicare & Medicaid Services) Request for Information which seeks input on changes to improve the organ transplant and donation system and both access to dialysis services and improved quality of care in dialysis facilities. The Request asked for input from such stakeholders as OPOs, ESRD providers and hospitals and very importantly from transplant recipients and their families and organ donors and their families. Because the Request was more on an individual rather than an organizational basis, TRIO will not be commenting as a national organization but does want to thank all of those individual members and chapters that have commented. Those comments were due by February 1. All public comments including any from TRIO membership as well as the original request can be found at: https://www.federalregister.gov/documents/2021/12/03/2021-26146/request-for-information-health-and-safety-requirements-for-transplant-programs-organ-procurement
Thank you to all who commented.
TRIO Public Policy Committee report for January 2022
CMS Request for Information (RFI)
CMS (Centers for Medicare & Medicaid Services) recently published a Request for Information (RFI). The request seeks input on changes to improve the organ transplant and donation system and both access to dialysis services and better quality of care in those dialysis facilities. The request also asks for input on how to reduce racial and disability inequities in the transplant system. Because of the wide-ranging scope of information requested, CMS is seeking input from all stakeholders such as OPOs, ESRD facilities and dialysis providers and hospitals and very importantly is seeking input from transplant recipients and families and organ donors and families. They are soliciting comments on ways to:
1. Continue to improve systems of care for all patients in need of a transplant;
2. Increase the number of organs available for transplant for all solid organ types;
3. Encourage the use of dialysis in alternate settings or modalities over in-center hemodialysis where clinically appropriate and advantageous;
4. Ensure that the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) policies appropriately incentivize the creation and use of future new treatments and technologies;
5. Harmonize requirements across government agencies to facilitate these objectives and improve quality across the organ donation and transplantation ecosystem.
And they are looking for this information in specific settings including Transplant Centers, ERSR facilities, Nursing Home Dialysis, Mobile Dialysis, and OPOs. However, in all of these areas they are including patient impact and the need for patient and family comment. Some particular areas for patient comment are noted especially including transplant center patient safety performance, satisfaction with care, quality of patient education, waitlist transparency and experience with organ offers. TRIO will be preparing comments on this RFI as a national organization but the RFI is specifically requests public comment and all TRIO members and Chapters are of course able to comment. Those comments will be due by February 1, 2022 and the formal request for comment can be found at https://www.federalregister.gov/d/2021-26146. Individual members and Chapters are encouraged to share their comments with the Public Policy Committee or share their thoughts with the Committee for inclusion with the TRIO National comments.
Part D
TRIO continues to actively participate in the Part D Coalition the goal for which is to preserve the six protected classes of drugs under Medicare. Those protected classes currently include a class for immunosuppressive drugs which obviously crucial for transplant recipients. The Coalition has recently been developing one-pagers on each of six protected classes for use in discussing the need to continue this benefit with Congressional staff. The various organizations which benefit from the current coverage have been working with Coalition staff to finalize these documents and TRIO has been part of this effort. These documents of course can have much broader educational uses. Once they are finalized the public policy committee will be sure to share the transplant drug one-pager with everyone for use as a resource.
UNOS Calls for Action on the Living Donor Protection Act (S.377/HR.1255)
UNOS is asking the public to show their support for promoting living organ donors. This bill, introduced by Senator Gillibrand and Representative Nadler, has outstanding bi-partisan support in the congress. Even though the act will expire on 12/31/2021, look for it to be introduced again in the next congressional terms. TRIO fully supports this UNOS call to action which is outlined below and you can very easily contact your representative with the included link.
UNOS call to action: Ask Congress to support the Living Donor Protection Act NOW! The Living Donor Protection Act will expire on Dec. 31! Help us get it through Congress by asking your representatives on Capitol Hill to lend their support. Here is the link to contact your member of Congress: https://p2a.co/V4FLUkR
In 2020, despite the pandemic, there were 5,726 living donor organ transplants. Unfortunately, living donors sometimes face discrimination when seeking life insurance, disability insurance, or long-term care insurance. The Living Donor Protection Act would establish protections for living donors to make sure they don’t face these hurdles. With living donor transplants down more than 23% during the COVID-19 pandemic, this legislation is more important than ever before. If you have questions about our new advocacy program, please contact This email address is being protected from spambots. You need JavaScript enabled to view it.. Thank you for all that you have done and all that you continue to do to serve the community.
Update on Continuous Distribution
The Public Policy Committee is actively following UNOS’ ongoing efforts to develop and implement a new and more equitable allocation system for deceased donor organs. That new system called the continuous distribution system will align the distribution system with the OPTN final rule. Broadly the new system will provide new mechanisms for balancing medical urgency, distance from the hospital, donor and recipient compatibility and survival. The Public Policy Committee is working to develop an article which will provide an overview of how the system will work as UNOS rolls out plans for each organ. We did want to report that UNOS in the last week announced the continuous distribution plan for lungs which may be implemented in 2023. The committee will continue to follow these activities and plan to provide an overview report within the next few months.
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