TRANSPLANT RECIPIENTS
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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 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.



To join in on the topic discussions visit the TRIO Bulletin Board to provide your opinions about these issues.