TRIO Legislative Action News

Public Policy Committee Activities
– Report to Chapter Leadership Council on April 1, 2020

Committee Members – Ira Copperman, Lorrinda Davis, Rodger Goodacre

National Activities
  • Participate on Secretary’s Advisory Committee on Transplantation (ACOT). Note that TRIO is working to become an official Committee Member.
  • Transplant Roundtable – Participate in meeting of all national groups with a stake in transplant related matters.,
  • Work on an ad hoc basis with federal agencies such as FDA and HRSA on specific projects or committees
  • Member of coalitions of transplant organizations focused on specific issues such as WaitList Zero, Honor the Gift Campaign, Part D Partnership for Access, NASH Alliance.
  • Attend Regional UNOS meetings.
  • Work with other organizations such as NKF, AST, AAKP, and APWA on specific projects and sign on to national letters.

Current Initiatives

The committee is currently working on four initiatives. All of these initiatives are currently on hold at some level given the current Covid-19 situation and the focus of the Congress on that issue.
  • Partnership for Part D Access – This group has been a watchdog to maintain the current six protected classes of drugs in the Medicare Part D program. Immuno-suppressive drugs are one of those classes and its continuation is particularly crucial to ensure that transplant recipients have full capability to choose the correct immunosuppressive regime. For example, only certain generics may work for an individual and the ability to choose among generic options or obtain the brand name drug is vital to protecting the transplant. The Partnership has been successful to date in halting any changes to the protected classes but it appears new efforts for changes may evolve later this year again using the largely unfounded position that it would increase competition among plans and lead to a decrease in drug prices. An even broader overall redesign of Part D may also be considered in the near future.
  • Honor the Gift Campaign – This is an effort sponsored by CareDx to extend Medicare coverage of transplant drugs beyond the 36 month period now in place for those kidney transplants covered only through the ESRD program. Currently, coverage for these patients stops after 36 months and many patients in this situation have experienced difficulties in accessing drugs and even loss of the transplanted organ. Plans had been to introduce a bi-partisan supported bill to completely eliminate the 36 month period this summer but the plan now is to possibly submit a bill to Congress this fall.
  • Improve the benefits through the National Living Donor Assistance Center (NLDAC) – The White House in July of 2019 issued an announcement later followed by an Executive Order aimed at increasing public aware of kidney disease and transplantation. The NLDAC was created to help subsidize the costs of Good Samaritan donors and there has been an effort since that time to increase the level of these benefits. HRSA, however, issued a proposed rule which would increase level of eligibility for donors which currently is at 300% of the federal poverty level only up to 350% of that level. This is significantly below the hoped for change and efforts continue to seek a larger increase.
  • Improve research and public knowledge about a class of liver diseases called NASH/NFALD which stands for non-alcoholic fatty liver disease. These liver diseases can lead to liver cirrhosis and the possible eventual need for liver transplant. This is an effort to highlight the scope and frequency of these diseases and to fund research and prevention. This could also lead to an increase in the number of livers for transplant in those situations where transplant is the only medical solution available.

Other Ongoing Committee Activities
  • The committee will continue to monitor the above activities and the impact of Covid-19 on the legislative process and impacts on the transplant community.
  • The public policy committee will continue its efforts to improve the public policy portion of the TRIO webpage and its availability to you as a resource.
Next Steps for Individual Chapters
  • Please consider the establishment of a chapter lead or chapter champion for public policy related activities. That individual would coordinate with our national committee and lead on state and local activities.
  • Review the Congressional transplant caucus list on the TRIO website to determine if your member is involved and reach out to your member and their health staff to make them aware of your organization and potentially invite them to a chapter meeting or go to their office to meet them and explain the importance of transplant role of TRIO. These same activities should be considered by state legislators and staff as well.
  • Alert TRIO national and the public policy committee to any state of local initiatives on transplant that could have national implications.
Thank you for your time and attention.

Update of December 15, 2019

Legislative activities around the US

The legislative and lobbying front continues to be a very active place in the world of transplantation.  There are major initiatives in pharmaceutical coverage, Medicare plans, the kidney health crisis, and even a review of NOTA, the National Organ Transplant Act of 1984.  NOTA was the Congressional act that created the transplant system in the United States, along with its governing laws and principles.

 The Partnership for Part D Access has been the watchdog to make sure that recipients have full capabilities to choose the correct immunosuppressive regime that works for each individual.

Last Spring, Medicare proposed changes that would have limited access to medications under the protected classes, including immunosuppressants.  Fortunately, the grassroots engagement of patients from across the country, including the transplant community, forced Medicare not to make the changes.  This is good news for the transplant community; however, the Partnership expects that the administration could try to make changes to the policy again in 2020. 
It is important for patients to remain vigilant and engaged.  You can get more information about the Partnership at its website,

 In addition to the efforts of the Partnership for Part D Access, there is another group, CareDX, focusing on the severe limitations of Medicare coverage for immunosuppression.  Right now, Medicare payments only last for 36 months once immunosuppression starts for patients enrolled in ESRD.   If you are covered by Medicare Part B for your immunosuppression, then your coverage continues past 36 months.  This group has worked tirelessly over the past year and has succeeded in getting the Congress to focus its attention on this issue.  The Coalition of partners in the HonorTheGift coalition expect a bill to be introduced into the House and Senate, with bi-partisan support, to correct this serious coverage issue.  Learn more about the efforts of this group at

 Last Spring, a group of clinicians formed an organization to help with research and publicity of the liver diseases called NASH/NAFLD.  This stands for non-alchoholic steatotopic hepatitis/non-alcoholic fatty liver disease.  This is a class of liver ailments that can lead to cirrhosis and even liver transplantation.  The group is working on a draft of legislation that would significantly highlight the need for attention to these ailments and fund major efforts in research and prevention.  More information about this group and these diseases can be found at

 The major announcement from the Executive Branch took place last July 10th with a push to increase public awareness on kidney disease, treatment, and transplantation.  A special edition of the TRIO E-Newsletter on July 15, 2019 covered the announcement.  Since that time, a group of individuals, including economists, living donors, and patient advocates, have been working with the Executive Branch to improve significantly the benefits of the National Living Donor Assistance Center (NLDAC).  The Center was created to help subsidize the costs of citizens willing to participate as a good Samaritan kidney donors.  You can find out more information about the NLDAC at its website,

 All of these efforts on behalf of transplant recipients and the backlog waitlist of those hoping for a gift need your help.  There is grassroots effort going on in each of these groups.  These groups are looking for you to add your time and your voice to their efforts.  Reach out directly to any of them or get in touch with Rodger Goodacre, at This email address is being protected from spambots. You need JavaScript enabled to view it., or Ike Copperman, at This email address is being protected from spambots. You need JavaScript enabled to view it., for more information. 

Another way you can stay informed is to appoint a legislative watchdog in your chapter.  We will make sure to keep your watchdog informed about activities in legislation and lobbying.

Update of November 14, 2019:

Subject:Part D Partnership Call of Nov 13

The Partnership for Part D Access (Partnership) held its monthly call on November 13, 2019.  A list of attendees is provided below.

H.R. 3 Update

Andy Rosenberg and Alex DelPizzo of Thorn Run Partners provided Partnership members with an update on the latest developments on Speaker Nancy Pelosi’s (D-CA) drug pricing bill. At a markup of the bill last month, Republicans on the Energy and Commerce Committee filed an amendment that would allow plans to exclude drugs within the protected classes if their price increases faster than inflation. Alex explained that Partnership reached out to Committee members and allies of the six protected classes policy to discuss the issue, expressing concerns about further injecting the protected classes into the drug pricing debate and oppose any effort to include such provisions in H.R. 3. While Committee staff largely agreed with Partnership’s decision, Alex noted that Republicans have been frustrated with patient groups for refusing to come out with a position against the sweeping drug pricing proposal. The amendment was not officially offered during the markup, but the Partnership will continue to be diligent and keep a close eye on the drug pricing debate following this development.

GAO Update

Andy went on to provide an update on the Partnership’s efforts to produce a study on the protected classes policy from the Government Accountability Office (GAO). As Catherine previously mentioned, there are two approaches are under consideration. The first would pursue research similar to what Avalere produced earlier this year with the goal of refuting arguments made by health plans that ascertain the plan is required to cover every medication, as well as highlight plan use of financial mechanisms — including fail first and prior authorization — to drive patients toward the plan’s preferred medication.  The other study would analyze data on the Part D appeals and grievance process — a process that was touted as a safeguard by the Trump administration and other opponents of the current six protected classes policy — to determine how often and effective this process is for patients requiring a medication from a protected class.


Andy reported that Senator Susan Collins (R-ME) has agreed to lead a letter to the GAO through the Senate Special Committee on Aging. He noted that the Partnership is still waiting on confirmation from Aging Committee Ranking Member Bob Casey’s (D-PA) office that he will join Sen. Collins on the letter. Other Senators that are interested in joining the letter to the GAO include Sens. Martha McSally (R-AZ), Kyrsten Sinema (D-AZ), Marco Rubio (R-FL), and Jacky Rosen (D-NV). Andy encouraged any Partnership members who have relationships with these offices to reach out to Catherine if you are able to help facilitate outreach. Arnie Clayman of American Society of Consultant Pharmacists said that his organization may be able to help in this regard.

Legislative Option

Andy also mentioned that the Partnership has begun working to formalize potential legislative option that would combat future changes to Medicare’s six protected classes. While the group has previously explored options that would remove the Secretary of Health and Human Services’ (HHS) ability to change the six protected classes, Andy explained that the new approach would create “guardrails” around the Secretary’s authority by requiring that HHS demonstrate that the proposed changes would not impact patient access, nor create increased costs in Medicare Part A, Part B, or Medicaid. Andy emphasized that this option is still a work in progress, and encouraged members to reach out to the team at Thorn Run with any questions, comments, or suggestions.

Meeting Participants

Diana Felner, Tourette Society of America
Ike Copperman, TSO
Kim Czubaruk Cancer Support Community
 Roger Goodacre, Transplant Recipients International Organization
 Lisabeth Iglesias, Lupus and Allied Diseases Association
Debbie Plotnick, Mental Health America
Arnie Clayman, American Society of Consultant Pharmacists
Bill Franco, Acadia
Hannah Baer, Acadia
Nick Rebholz, Johnson & Johnson
Bela Sastry, Sunovian
Theresa Jolivette, Sunovian
Dan Harder, Allergan
 Andy Rosenberg, Thorn Run Partners
Alex DelPizzo, Thorn Run Partners

Honor the Gift Campaign
There is a new bill introduced in the United States Senate. What follows is some information with respect to that bill:

TRIO has worked hard to forward the goal of extending Medicare coverage of immunosuppressive drugs for kidney transplant recipients beyond the current 36 months post-transplant. It was hoped that this would be part of any health care reform legislation that was passed. It was not, however, part of the health care reform legislation that was passed. Although this legislation was included in the health bill approved by the House of Representatives in November of 2009, the bill and this important legislation were not contained in the Senate bill in December nor in the final legislation signed by the President in March of 2010. However, the original immunosuppressive bills (S. 565, H.R. 1458) remain active and I would ask you to please help by asking your Representatives and Senators to become cosponsors if they are not yet cosponsors. Please contact your Senators and Representative to urge them to cosponsor the Senate bill- S. 565 and The House Of Representatives bill- H.R. 1458, respectively.


Prior to 2000, immunosuppressive drug coverage was limited to 36 months following a transplant for all kidney transplant recipients. In the Beneficiary Improvement and Protection Act of 2000, Congress eliminated the 36-month limit for transplant recipients who had a Medicare transplant, if they are eligible for Medicare based on age or disability. Recipients would pay the individual portion of the Part B premium, and Medicare would be extended beyond 36 months only for recipients who lack other health care coverage. All other health care needs for transplant recipients who are not Medicare aged or disabled would remain subject to the current ESRD 36-month coverage limit.

Organ transplant recipients must take immunosuppressive medications for the life of the transplant to help prevent the body from rejecting the organ. HR 1458 would extend immunosuppressive drug coverage for Medicare-eligible kidney transplant recipients for the life of the transplant. They would not necessarily have access to other parts of Medicare, but this would ensure that they could retain Part B access to these expensive medications. Currently, Medicare pays for most kidney transplants but covers medications for only 36 months post-transplant as part of the Medicare ESRD benefit.

Many kidney patients lose access to Immunosuppressive medications. In a study of 1,000 kidney transplant recipients, graft loss more than doubled when Medicare coverage for anti-rejection drugs ended. This is associated with a significant cost to Medicare and the taxpayers because patients who lose transplanted kidneys must return to dialysis or seek another transplant. Furthermore, once a transplanted kidney no longer works, the patient’s risk for death is nine times as large!

In a survey by the United Network for Organ Sharing and the American Society of Transplantation, 70% of transplant centers report that patients have extreme or very serious problems paying for their medications, and 68% of kidney transplant deaths or graft failures are possibly the result of lack of access to anti-rejection medications.

According to the most recent report from the United States Renal Data System, Medicare spends an average of $77,000 per year indefinitely dialyzing patients with kidney failure. However, it spends $106,000 the first year after transplant and an average of $17,000 per year thereafter, including the cost of Immunosuppressive medications. It thus makes financial sense for Medicare to remove the 36-month coverage limitation for Immunosuppressive medications.

In the most recent report, we discussed an important bill introduced in the United States Senate. Today, I'm pleased to announce that a companion bill has been introduced in the House of Representatives with bipartisan support and co-sponsorship. In the House of Representatives, Michael C. Burgess, M.D. (R–Texas) and Congressman Ron Kind (D–Wisconsin) introduced the Immunosuppressive Drug Coverage for Kidney Transplant Patients Act. This legislation, H.R. 2969 will allow individuals who are eligible for immunosuppressive drugs under Medicare Part B to continue to receive their vital treatment past the 36-month cutoff. Without these medications, transplant recipients are at risk to lose their transplanted kidneys which has too often happened.

Since 1972, Medicare has covered people with irreversible kidney failure, or end-stage renal disease (ESRD). There is no Medicare time limit for a dialysis patient. However, kidney transplant recipients lose their Medicare coverage 36 months after a transplant. Extending immunosuppressive coverage beyond the 36-month limit would decrease the risk of organ failure due to patients neglecting to take the immunosuppressants following loss of immunosuppressive coverage. Furthermore, it has been found that transplant recipients have a higher quality of life, and are more likely to return to work than dialysis patients.

Take action now:

Reach out to your legislators and express your support of the important legislation above. The life you save may be yours or that of others around the country with your actions.