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.
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:
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:
For more information, check out the following articles:
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:
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):
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.
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:
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:
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.
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.
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/.
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.”
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.
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.
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.
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
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.