TRANSPLANT RECIPIENTS
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TRIO Public Policy Committee Reports

TRIO Medical Advisory Board member and kidney transplant surgeon, Dr. Tom Peters, speaking on policy at NKF conference

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.


PUBLIC POLICY COMMITTEE REPORT FOR SEPTEMBER 2020

Partnership for Part D Access

The team monitoring federal legislative and executive activities on behalf of our prescription drug policy has stayed involved throughout this year.  Catherine Finley, from Thorn Run Partners, continues to work for our coalition to stay informed. 

During the last monthly with the members of the coalition, she reported that there doesn’t seem to be any activities occurring that require grassroots involvement at this time.  The federal government and its agencies are too taken up with economic issues surrounding Covid-19.

Catherine did assure the Coalition that her team is looking forward to 2021 to make sure that Thorn Run has appropriate plans in place post-election.

Continuous distribution

For several years, UNOS has undertaken to improve organ allocation and distribution to make sure that transplantation occurs without regard to geographic barriers.  Major improvements in reducing transportation times have allowed for a much broader placement of organs without regard to city, state, or any geographic hindrance.  This has allowed UNOS to procure and send organs almost anywhere in the continental United States and make sure it is transplanted to the most medically needy waiting recipient.

To date, UNOS has created policies that have widened the distribution circle between donor hospital and transplant center.  Improvements in distribution have led to policies changes for kidney, pancreas, heart, and lung transplantation.

After more years of study, UNOS has released a new study for public comment that includes geographic considerations as just one factor in the distribution decision.  This study is called continuous distribution. 

According to UNOS, “Organs can be distributed to candidates using a statistical formula that combines important clinical factors, such as medical urgency and post-transplant survival, along with proximity to the donor location. Using this approach, all candidates would receive a composite allocation score, but there would be no absolute geographic boundary. Candidates who receive the highest score based on their combination of factors receive highest priority.”

UNOS is inviting the public to weigh in on this study by taking a survey allowing the public to contribute to the decision-making activities prior to a final implementation of any policy changes.

Details on this survey can be found at the following UNOS.ORG website page:

https://optn.transplant.hrsa.gov/governance/public-comment/update-on-the-continuous-distribution-of-organs-project/

UNOS ACTIVITIES

UNOS has maintained a very busy schedule to make sure that transplantation in the United States returns to pre-Covid levels.  And in the past 60 days, many transplant centers are operating at or above transplantation activities attained in 2019, a record year for transplantation.  As of September 10, 2020, there have been more that 10,200 donors providing more than 22, 000 transplants.

In addition, UNOS has embarked on a very impressive list of research and development activities to bring important improvements to the transplantation processes managed at UNOS.

UNOS has several pilot projects involving adding GPS tracking devices to the transportation activities involved when bringing organs from a donor hospital to a transplant center.  This will make sure that the transplant center is in the best state of readiness to begin the surgical procedures for a waiting recipient.

UNOS has also created new simulation models to help anticipate program changes that may be needed in the light of the COVID pandemic.  This will allow UNOS to adapt resources to needed geographic areas.

UNOS is also in the middle of creating a paired liver exchange program, designed along the lines of the paired kidney donation programs that were created several years ago.  This will be a program to pair one donor and one recipient.

Finally, UNOS is creating another simulation program to help transplant surgeons get trained on best practices to accept an organ offer, to determine why one center will accept an organ that another center won’t accept. 

All of these projects will allow UNOS to make sure that organs are recovered and distributed in the best possible manner to increase transplantation rates.

 

PUBLIC POLICY COMMITTEE REPORT FOR AUGUST 2020

UNOS ACTIVITIES

UNOS has kept up a very active calendar during the pandemic, going beyond its mission to facilitate donation and transplantation.  UNOS has sponsored a series of public interest webinars to inform the public about its role in the past 5 months, as well as sending out weekly emails.

The latest webinar took place on July 24th.  It was titled “COVID-19:  Past, Present and Future Transplant Center Operations.”  This webinar brought together a panel of transplant program administrators from 3 major centers across the United States.  The panel consisted of Brigitte Sullivan, executive director, NYU Langone Transplantation Institute; Jennifer Milton, chief administrative officer, UT Health San Antonio; and Angie Korsun, executive director, Advanced Organ Management Services, Banner Arizona.

The group discussed the efforts their organizations undertook to continue to function for transplantation during the COVID pandemic.  The UNOS organ allocation procedures, hospital rule books, organ procurement, and organ testing were just a few of the areas that were altered virtually overnight as the alarming extent of the pandemic became known to the transplantation community.

The practices that these centers created will now serve as a playbook for the future.

HR 6448 – ORGAN DONATION CLARIFICATION ACT

The National Organ Transplant Act of 1984 (NOTA) established the guiding principles for transplantation in the United States.  The act included provisions for administration, data collection, peer review, infrastructure, and ethical considerations that have remained mostly unchanged for more the 35 years.

Several years ago, Representative Matt Cartwright from Pennsylvania, a staunch friend of donation and transplantation, introduced HR 6448, a bill to modify the definition of valuable consideration for organ donation to broaden the manner that living donors and donor families could receive some forms of compensation for organ donation.  The bill went nowhere at that time, in spite of receiving good support from his House colleagues. 

On July 31, 2020, Representative Cartwright re-introduced HR 6448 as HR 7900 with the hopes that the bill would move forward this year because of the heightened awareness of the plight of organ donation.

At the national level TRIO supported the bill when it was initially proposed in 2018 and continues that support for the re-introduced version.   Please read up on HR 7900 as information becomes available and be prepared to make your support known to your local representatives.  More information will be forwarded to you in the upcoming months.

 

UNOS ACTIVITIES FOR ORGAN ALLOCATION AND DISTRIBUTION

UNOS as spent a great part of the last several years making major changes to the allocation and distribution processes for every solid organ.  In recent times, UNOS has introduced changes to the heart, lung, liver, kidney, pancreas, and kidney/pancreas programs to create more equitable allocation placement from donor to recipient.  This is all in keeping with the UNOS Final Rule, requiring organ placement without regard to the geography of donor and recipient. 

With the latest scientific and medical advances in organ transport systems, equitable solutions are now well in hand.  These advances have made it possible to move organs across the country and still maintain the necessary requirements for organ viability, especially as concerns ischemic times.

The most current effort in determining organ distribution and allocation is called the continuous distribution model.  This involves an algorithm that will assign a number to every person on the waiting list by organ type.  When an organ becomes available, it will be offered to the person with the highest number on the list, regardless of geography.

The analysis of the continuous distribution model continues at UNOS.  As a significant portion of this analysis, UNOS has launched a major effort to get public input into the process.  We hope that all of you will participate in this very exciting program to provide direct feedback into the UNOS policy making process.

This effort is described below:

Participate in a Prioritization Exercise for Continuous Distribution

The Lung Transplantation Committee is seeking feedback from the community to inform the development of the new framework for organ allocation - continuous distribution.

The community is invited to participate in a prioritization exercise through October 1. You do not need to be a clinician, lung transplant professional or lung patient to participate.  

·  Read more about continuous distribution in the request for feedback paper open for public comment

·  Sign up to participate in the 15 minute exercise – you will receive resources and a link to participate after filling out a short submission form.

EXECUTIVE ORDERS ON DRUG PRICING

On July 24 President Trump signed a series of Executive Orders on drug pricing that included potential changes in the areas of Medicare Drug Rebates, Insulin and Epinephrine for Low Income Patients, Drug Importation, and Medicare Pricing for Certain Drugs Tied to Pricing in Other Countries.  Details on these policies as well as potential implementation dates have not yet been released and as these details and further information become available your Public Policy Committee will review these developments and provide additional reporting.  

 

 

 

 

Uppdate: June 16, 2020

 

In 1973, Congress made a commitment to patients living with end stage renal disease (ESRD) which allowed their treatment to be covered by Medicare regardless of age or disability status. Under the current arrangement, Medicare will cover the cost of dialysis – totaling more than $85,000 per patient per year – and after waiting an average of five to eight years for the gift of a new kidney, Medicare then covers the cost of the kidney transplant totaling more than $110,000.

 

 

Three years after a transplant, Medicare’s coverage of daily anti-rejection medications that kidney transplant recipients depend on for the rest of their lives and cost less than $3,000 per year, stops. When a patient loses their coverage, they’re must find the funds to pay for medication on their own. What happens to this vulnerable population? They spread out their medications to make them last longer, they face the financial burden as best as they can – deciding between food on the table or medication, they reject their donated gift and they go back on dialysis, or, sadly, they die. The current Medicare policy cannot be justified morally, medically, or economically, and it must be changed.

 

 

Over the last several months, TRIO - Transplant Recipients International Organization, has been working with Honor the Gift, a patient-centered grassroots campaign focused on addressing the immunosuppressive medication coverage issue. Since launching on March 1 in 2019, the campaign has seen great support from both the kidney and transplant community and has successfully resurrected this issue once again in Washington, DC.

 

 

In 2019, under the leadership of Secretary Alex Azar – whose father was a kidney transplant recipient – the Department of Health and Human Services (HHS) released two reports which estimated that extending coverage of anti-rejection medications could save Medicare up to $300 million over 10 years.

 

 

The community and the Administration have both shown their support for extending Medicare’s coverage limit on immunosuppressive medications, now it’s Congress’ turn. The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act was just introduced again in Congress this year and we need your voice to ensure it gets passed! Please contact your members of Congress today and urge them to stand with kidney transplant patients and #HonorTheGift of their kidney donors and donor families.

 

 

How you can help:

 

Contact your legislators today!  You can use the Honor the Gift site at https://honorthegift.org/act/

 

You can also go to the TRIO website and under the Public Policy tab there is a link which provides you information on how to contact your congressperson directly.

 

 

Spread the word on social media.  Below are three suggested social media  posts on Facebook, Twitter or other sites.  Please consider sending the information to you contacts on posting on the Chapter website.  If you use Twitter, please ask the recipients to retweet!

 

 

Click here to download graphics

 

 

·         The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act was just introduced in Congress! Contact your members of Congress today to make sure they’re supporting the bill. https://honorthegift.org/act/ #HonorTheGift    #TRIO

 

 

·         Many kidney transplant recipients are at risk of losing access to their immunosuppressive medications this year. Contact your members of Congress and urge them to #HonorTheGift of kidney donation at https://honorthegift.org/act/ #TRIO

 

 

·         Kidney transplant recipients need your help! Contact your legislators today and urge them to support the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act! https://honorthegift.org/act/ #HonorTheGift    #TRIO

 

 

 

Spread the word through your newsletter or ask other groups to spread the word.   Sample wording for an article follows:

 

 

trio newsletter call to action

 

Did you know that Medicare will cover the cost of dialysis and a kidney transplant, but cut off a patient’s anti-rejection medication coverage just three years after they get their transplant? We’re working to change that – but we need your help! Ask your members of Congress to stand with kidney transplant patients and #HonorTheGift of kidney donation today – Support H.R. 5534 and extend Medicare’s coverage of immunosuppressive medications for kidney transplant patients! ACT NOW! https://honorthegift.org/act/   #TRIO

 

The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act was just introduced in Congress! Contact your members of Congress today to make sure they're supporting the bill. Click here: Honor the Gift

Click here to view the January 17th TRIO E-News Special edition with full details on this important issue calling for your ACTION

Update: March 12, 2020

The Honor the Gift Coalition Celebrates the Senate’s Bipartisan Introduction of the Immuno Bill

WASHINGTON, D.C., – At the end of February, the Senate introduced legislation that would extend Medicare coverage of immunosuppressive medications for kidney transplant recipients.

The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (S. 3353) introduced by Senators Bill Cassidy, MD (R-LA) and Dick Durbin (D-IL)—would allow kidney transplant recipients to maintain Medicare Part B coverage for immunosuppressive medications beyond the current 3-year limit, extending coverage for the lifetime of the transplanted kidney. Sens. Cassidy and Durbin we’re joined by Sens. Joni Ernst (R-IA), Jeanne Shaheen (D-NH), Sheldon Whitehouse (D-RI) and Todd Young (R-IN) as original cosponsors. The House of Representatives introduced a companion measure of the Immuno Bill late last year.

Statement from Honor the Gift on the Immuno Bill’s bipartisan introduction in the U.S. Senate:

Today marks another significant milestone for the members of the kidney and transplant communities who have been advocating for this policy change for nearly 20 years. With today’s introduction in the Senate led by Senators Bill Cassidy and Dick Durbin, we’re one step closer to finally guaranteeing that kidney transplant patients won’t lose their transplanted organ due to an inability to pay for their lifesaving immunosuppressive medications.

Now that the Immuno Bill has been introduced in both the House of Representatives and the Senate, we call on every member of the kidney and transplant community to take a stand for recipients, donors and donor families – it’s time for all of us to contact our members of Congress in support of this legislation. Together, we’ll be able to protect kidney transplant patients and save lives, honor the gift of their donors and donor families, and according to the U.S. Department of Health and Human Services, the legislation will result in significant savings for the Medicare program.

Advocates can contact Congress and express their support for the Immuno Bill by visiting the Honor the Gift website and utilizing our digital advocacy tool.

Learn more about the Honor the Gift coalition’s efforts to extend Medicare coverage of immunosuppressive medications for kidney transplant patients at HonorTheGift.org.

 TRIO - Transplant Recipients International Organization, has been working with Honor the Gift, a patient-centered grassroots campaign focused on addressing the immunosuppressive medication coverage issue. Since launching on March 1 in 2019, the campaign has seen great support from both the kidney

and transplant community and has successfully resurrected this issue once again in Washington, DC.

In 2019, under the leadership of Secretary Alex Azar – whose father was a kidney transplant recipient – the Department of Health and Human Services (HHS) released two reports which estimated that extending coverage of anti-rejection medications would result in significant savings for Medicare.

The community and the Administration have both shown their support for extending Medicare’s coverage limit on immunosuppressive medications, now it’s Congress’ turn. The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act, H.R. 5534 and S. 3353, has been introduced again in Congress and the Senate this year and we need your voice to ensure it gets passed! Please contact your members of Congress today and urge them to stand with kidney transplant patients and #HonorTheGift of their kidney donors and donor families.

Contact your legislators today! https://honorthegift.org/act/

How you can help:

Contact your legislators today!  You can use the Honor the Gift site at https://honorthegift.org/act/

You can also go to the TRIO website and under the Public Policy tab there is a link which provides you information on how to contact your legislators directly.

Spread the word on social media.  Below are three suggested social media posts on Facebook, Twitter or other sites.  Please consider sending the information to you contacts on posting on the Chapter website.  If you use Twitter, please ask the recipients to retweet!

Click here to download graphics

·         The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act has just been introduced in the Senate! Contact your legislators now to ask that they support this life-saving legislation! #HonorTheGift #TRIO  https://bit.ly/35S9T9K

·         Many kidney transplant recipients are at risk of losing access to their immunosuppressive medications this year. Contact your legislators and urge them to #HonorTheGift of kidney donation at https://honorthegift.org/act/ #TRIO

·         Kidney transplant recipients need your help! Contact your legislators today and urge them to support the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act! https://honorthegift.org/act/ #HonorTheGift    #TRIO

                                                                        SPREAD THE WORD

 

Recent committee reports:

Update on Medicare Part D Protected Classes of Medications
Jan 2020

Physicians and pharmacists have known for a long time that different generic versions of the same drug work differently from one patient to the next. So, the generic version of Prograf, called Tacrolimus, can perform differently on immunosuppression from manufacturer #1 than from manufacturer #2.

The Congress recognized this fact more than 15 years ago and created a special section of the Medicare Part D Prescription Drug Program called the protected classes. Immunosuppression for transplant recipients is one of the protected classes. Under this special section of Part D, pharmacies must carry a range of the same generic drug that allows a patient to have a prescription filled exactly the same from a single manufacturer every time a prescription is presented.

In 2014, the Obama Administration proposed weakening the protected classers by removing protected status from three classes of medication, including immunosuppressants. Recognizing this assault, a dedicated coalition of patient groups came together to form the Partnership for Part D Access. The purpose of this group was simple: to guarantee that a patient in any of the protected classes would be able to fill a prescription the same way every time a refill was needed. When faced again, in 2019, with damaging actions by the Trump Administration, the Partnership for Part D Access again stepped in mobilizing patients from across the nation to oppose the proposed policies.

To date, the Partnership has been successful in making sure that CMS and the Medicare program continue the protected class program as formulated by Congress. Studies have been commissioned and presented to Congress and to HHS showing that there are no cost savings that make sense by reducing the number of drugs in the protected classes that are covered by Medicare.

The vigilance over the protected class program is ongoing. Right now, the program is stable and unchanged. However, there are always factions in the Legislative and Executive branches that want to make a change in the name of “economy”.

As a member of the Part D Partnership, TRIO will continue to work with all interested parties to guarantee access to prescriptions every single day. Please watch this page for any new developments that ask you to make a grassroots effort to maintain your rights!

For more information on the efforts of the Partnership for Part D Access, please go to the website: www.partdpartnership.org.

NASH/NAFLD
Jan 2020

 A dedicated group of physicians, researchers, and public health officials have come together to publicize the growing epidemic of the class of liver diseases called NASH/NAFLD.This stands for Non-Alcoholic Steatotopichepatitis/Non-Alcoholic Fatty Liver Disease.This class of diseases attacks the liver and can lead to cirrhosis and the need for transplantation.The website for this group is the NASHALLIANCE.ORG.The Alliance is made up of a staff of 15 professionals including physicians and educators.There are also 8 affiliated organizations that support the aims of the Alliance, including TRIO.

The group has been very active in promoting awareness through education.In addition, the group is working with a number of federal government agencies for public education funds as well as research grants and programs.

The group is also helping to draft legislation that would expand the coverage of NASH/NAFLD into the public health space through the National Institutes of Health (NIH). Through an act called National Authorization for Nonalcoholic Steatotopichepatitis Act of 2019, the Centers for Disease Control and Prevention (CDC) would give community-basedgrants and fund studies to promote awareness and treatment and more importantly, prevention of the disease through education.

NASH/NAFLD has the potential to lead individuals to a world of transplantation.TRIO is committed to continue as a partner in the NASH Alliance to prevent the spread of this silent killer.

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