National Public Policy Report April 2021

Update on Activities Involving Congressional Committees

Over the past several years, TRIO and other transplant patient support groups have participated on the National stage in support of legislative activities that promote transplantation issues. These issues affect recipients and caregivers, living donors, and other parties that make up our world!

Our outreach activities include direct contact with Congressional members of three important committees in the Congress that weigh in on transplant legislation and oversight. These committees are the House Energy and Commerce Committee, the House Ways and Means Committee, and the Senate Finance Committee. The Ways and Means Committee focuses on Medicare, the Energy and Commerce Committee focuses on Medicaid, and the Senate Finance Committee focuses on both programs. We call and email the staff members in charge of health policy in these committees.

Here’s a link to the staff of these members of Congress click here.  This list is useful if you want to send an email to a member, especially if you are a constituent.

Another important group is the Congressional Organ Donation Caucus, chaired by Representative Jim Costa from California. TRIO is working with Representative Costa’s office to obtain a current list of those members.

 Honor the Gift campaign victory

Our efforts have paid off! In February, we celebrated the most significant legislative victory for the transplant community in over 10 years, with the passage of the Immuno Bill! Under this legislation, Medicare payments for immunosuppressive drugs for kidney recipients is extended beyond 3 years after transplant. This legislation will take effect in 2023.

Update on Part D activities involving the six protected classes of medication

There is excellent news on Part D. In the last days of the Trump administration an effort had been again launched to end the six protected classes of drugs, which include immunosuppressive drugs.   The Biden administration has terminated that effort and the six protected classes will retain that status. In a side development, the organization that has been leading the effort to maintain the protected classes has stepped back from that leadership role. TRIO along with many other patient organizations will continue to work with the new leadership of this effort as the situation evolves. We will continue to play an active role in advancing the interests of our community to protect access to the immunosuppressant drugs we need.

Please find a press release at the following location: click here that details all of the efforts that went into the work of successfully maintaining the protected classes.

Covid, Vaccines and Transplant Recipients

The public policy committee has been following many presentations on covid, vaccines and the transplant community over the past several months.  The committee found that a meeting held on April 14 by the New York Presbyterian (NYP)-Columbia Transplant Forum which was led by Dr. Jean Emond, head of transplantation at NYP-Columbia, and 5 other members of the Columbia transplant team which included a wide-ranging discussion on the effects of COVID-19 on transplant recipients to be particularly useful and the committee wanted to share a summary of those proceedings.

Experts from lung transplantation, infectious diseases, surgery, pediatric transplantation, and nephrology discussed all aspects of the COVID pandemic from the recipient’s perspective.  One of the most interesting discussions came from Dr. Tomoaki Kato, a world-renowned transplant surgeon.   He was a COVID patient early on in the pandemic and was hospitalized for many weeks with a serious form of the infection before much was known about it.  He has completely recovered and is now back full time in the operating room performing transplants as before.

All of the physicians stressed similar points.  You can recover from a bout with Covid, but it is best avoided if possible.  That means to get the vaccine regimen.  Any of the vaccines, Moderna, Pfizer, J&J, or AstraZeneca, are safe for recipients.  None of them are based on live viruses to mount the immune response to COVID.

There were also comments made on the recent Johns Hopkins study of vaccine effectiveness.  All of them said the study results were far too preliminary to be useful.  And the study only looked at one part of immunological response.  The study did not examine the other parts, T cell and B cell activities.  NYP Columbia is in fact in the midst of a study looking at all of the parts of the immunology system.  This should be available soon.  A question was raised about a third shot of the vaccine, a booster, in effect.  The physicians all acknowledged that this is a possibility but again needed more study.

The physicians then stressed the need to continue with all of the pre-vaccine practices that are familiar to all of us: wear masks, continue social distancing, and wash hands as often as necessary.

 Living Donor Protection Act

TRIO has recently joined with many other organizations in support of an effort currently led by the National Kidney Foundation in support of insurance equity for living donors.  Approximately one in three kidney transplants are from living donors but a recent study showed that a quarter of those living donors were rejected or offered higher premiums for life or health insurance.

This bill will protect living organ donors nationwide and remove barriers to donation by prohibiting insurance companies from denying or limiting life, disability, and long-term care insurance to donors, as well as from charging higher premiums. Through changes to the Family and Medical Leave Act (FMLA), it also extends job security to living organ donors while they recover from donation.  Some seventeen states already have a version of this legislation and the public policy committee will be providing further information about this and it can provide an excellent opportunity for grassroots activities for chapters in states without this legislation.

You can use the link provided in the first article in this month’s report “Update on Activities involving Congressional committees” to contact your legislator who might be directly involved with health care policy to express your personal support for this legislation.

 #NKF #triookla #LivingDonors #MakeADifference #NationalDonateLifeMonth

Individuals also can cut and paste the link below from the National Kidney Foundation and add the comments above to support the effort along with TRIO as a national organization.

Ask Congress to Support the Living Donor Protection Act • National Kidney Foundation

National Public Policy Report March 2021

PART D ACCESS IS AGAIN IN THE NEWS

Since the beginning of the Trump Administration, the Partnership for Part D Access in which TRIO has played an active role has continued to keep abreast of potential activities that could negatively impact the 6 Protected Classes coverage which includes immunosuppressive drugs under Medicare Part D.  And the efforts of the Partnership paid off by maintaining close relationships with key members of congress who have long been champions of the 6 Protected Classes and the benefit has remain in place as currently structured.   However, on January 19, 2021, virtually at the final hour of the outgoing presidency, the Secretary of HHS issued directives that would ultimately lead to elimination of the protected classes and thus limit our access to the drugs we need through Part D.

In just a few short weeks, the Partnership has once again mounted a campaign which includes congressional meetings, letters from key committee chairs, and meetings in the new administration to stop any program that eliminates the protected classes.  TRIO has signed on to letters asking the President and Congress to maintain the program and members of the Public Policy Committee will take part in meetings with Congressional staff to advocate for continuing the protected classes.

Your direct involvement is again needed in the upcoming weeks and months to continue the efforts for our ability to stay on our drug regimens.  TRIO will continue to work with the Partnership and will continue to reach out to you for your involvement, with emails, letters, even phone calls.  The Public Policy Committee has prepared an Action Alert which appears elsewhere on the TRIO webpage with activities that you can take immediately to help protect these benefits

REVISED KIDNEY ALLOCATION POLICY TO TAKE EFFECT IN MARCH

The UNOS Revised Kidney Policy is due to take effect on March 14, 2021. Its implementation had been scheduled for last year but was delayed. This Revised Kidney Policy eliminates the use of Donation Service Areas (DSAs) and OPTN regions as units of distribution for kidney allocation, and replaces them with a 250 nautical mile circle around the donor hospital. The goal of the policy is to ensure potential kidney recipients have more equitable access to kidney offers, regardless of where their transplant hospital is located.  This would lead to the patients with the most severe conditions becoming more likely to receive organs sooner.  Implementation of the policy had been delayed by a challenge from Health Resources and Service Administration which is part of the Department of Health and Human Services that included addressing the impact of COVID-19 on transplantation among other issues. One interesting fact is that despite the pandemic, deceased donor kidney transplants were higher in 2020 than the number of deceased donor kidney transplants in 2019.

REGIONAL MEETINGS AT THE UNITED NETORK FOR ORGAN SHARING (UNOS) TRIO members have unique opportunities to help make the organ transplantation work system work at its best by sharing the way in which transplantation has affected our lives.    As the organization that administers the organ transplantation system in the United States, the United Network for Organ Sharing (UNOS) is at the forefront of managing the Organ Procurement Transplantation Network (OPTN) in a transparent manner.   Here is a description, from the UNOS website, of the way the public is invited and encouraged to participate in the policy-making activities at UNOS:

“Continuous advances in the science and practice of organ transplantation require ongoing refinement of policy that involves experts in the field as well as the public and the larger donation and transplant community. To ensure the best possible solutions for patients awaiting transplantation and for the donors whose precious gifts make that possible, the policy development process is:

Inclusive – encouraging participation by interested persons and organizations

Responsive – assessing and modifying policies to remain current with the field

Equitable – helping to ensure that all patients have an equal chance of receiving a suitable organ

Evidence based – making decisions based on extensive and valid scientific data and analysis”

UNOS is transparent in its activities.  Its website, https://www.unos.org  is easy to navigate and to use.  The site gives access to real-time transplant data, as well as access to public policy proposals and on-going discussions, committees, staff members, and management. UNOS divides the country into 11 regions.  Each region holds two meetings each year, one in February/March, and the second inSeptember/October.  These meetings are always open to the public; after registering, anyone can log onto a regional meeting, and listen to the activities, committee reports and voting, and updates from UNOS management.  The winter meetings have started but there is still time to register for your regional meeting and attend.  For more information about the UNOS regional meetings, check out the following website:  https://optn.transplant.hrsa.gov/members/regions/regional-meetings/

National Public Policy Report

Your Public Policy Committee is committed to the broadest possible sharing of information about legislative and policy activities that can benefit the entire transplant community. One of the ways we plan to advance that commitment is by sharing information about positive activities in local areas with the larger community. We are thus asking that you please share with us any information you might have about specific legislation that is already in place in your State or under consideration in the state legislative process so that we can share these potential best practices as widely as possible. Please do not hesitate to contact Rodger Goodacre at rodger.goodacre@gmail.com, Ira Copperman at irajay2004@gmail.com or Lorrinda Davis at ldavis@trio-oklahoma.org. Thank you in advance and we look forward to talking and working with you.

THE PARTNERSHIP FOR PART D ACCESS

The regular monthly meeting of the PARTNERSHIP activities group met recently to keep its members informed on the latest legislative and departmental activities affecting open access to prescription drugs under the protected class policies on Medicare. Changing the policy could cause serious disruption in the ongoing mental and physical health of protected class patients. Catherine Finley from Thorn Run Partners, the long-time guiding member of the Partnership, updated the group on several points: The political and election activities for most of this year have kept the limelight from seeing any substantive changes or recommendations to alter current policies that affect the protected classes; The Partnership is committed to establishing contact with the new Executive leadership team as soon as possible in 2021; The Partnership will commission an updated Avelere report, available in 2021, that has been very important in past years to convince the Legislature that the protected class policy has no impact on prescription drug costs. And subsequent to her briefing an important research paper was published in the American Journal of Managed Care which confirmed that generic drugs are dispensed in the protected classes at the same rates as they are dispensed generally. This finding further negates a key argument that proponents of eliminating the protected classes use in that it shows there would be no cost savings associated with the removal of the protected classes by taking away what they argue is an incentive to prescribe more expensive name brand drugs.

ORGAN ALLOCATION POLICY

The Government Accounting Office (GAO) recently issued a report that discusses the changes in organ allocation policy that UNOS has implemented in the past several years. A very important part of this report concludes that the policies that UNOS created for this change were created in a very fair and open manner, with a great deal of community input from the professional groups to the interested public groups. As an adjunct to the GAO report, UNOS also released a report recently that cites an incremental increase in liver transplantation as a result of the new liver allocation activities that began about one year ago. These changes reflect the importance of the Final Rule in UNOS’s allocation policies.
Changes continue to be made to allocation policies across all of the solid organ categories. The latest changes will come in December, 2020, with the elimination of geographic borders for kidney, pancreas, and kidney-pancreas distribution. Changes have already been implemented for heart, lung, and liver allocation. The Senate Appropriations Committee however has recently released a package of spending bills for 2021 that impact transplantation by potentially keeping smaller geographic border in place during the period that Covid 19 travel restrictions impact transport availability and timing. This package is generally used in negotiations with the House leading up to approval of spending programs and is not expected to have longer term effects.

NEW RULE FOR ORGAN PROCUREMENT ORGANIZATION (OPO) PERFORMANCE MEASUREMENT

On November 20, the Centers for Medicare & Medicaid Services (CMS) finalized a rule designed to increase the supply of organs available for transplant in the United States. The rule enacts reforms of the Medicare Conditions for Coverage for Organ Procurement Organizations (OPOs). OPOs are non-profit organizations responsible for evaluating and procuring organs for transplant from deceased donors. These organizations also provide support to donor families, clinical management of organ donors, and professional and public education about organ donation. Currently, there are 58 OPOs in the United States, each assigned to its own Donation Service Area. The rule creates new measures designed to hold OPOs accountable for seeking and ensuring transplant of as many organs as possible. The first measure change is to the donation rate measure. The changes encourage OPOs to pursue all potential donors, even those who are only able to donate one organ. The second measure change is to the organ transplantation rate measure. OPOs will no longer receive credit for simply procuring an organ rather the organ must be actually transplanted. CMS will also be making outcome measure performance public to increase transparency. This will highlight OPOs that fall outside of the top 25% in donation and transplantation rates and will help OPOs identify areas for improvement.
For a fact sheet on the final rule (CMS-3380-F), visit: https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos To view the final rule (CMS-3380-F), visit: https://www.cms.gov/files/document/112020-opo-final-rule-cms-3380-f.pdf

November 2020

National Public Policy Report

CONTINUING ACTIVITIES WITH TRANSPLANTATION

Transplantation topics continue to be an important part of the news and the public agenda with important activities in the past several weeks.

THE PARTNERSHIP FOR PART D ACCESS

The regular monthly meeting of the PARTNERSHIP activities group met recently to keep its members informed on the latest legislative and departmental activities affecting open access to prescription drugs under the protected class policies on Medicare.
Catherine Finley from Thorn Run Partners, the long-time guiding member of the Partnership, updated the group on several points:
1.  The political and election activities for most of this year have kept the limelight from
seeing any substantive changes or recommendations to alter current policies that
affect the protected classes.
2.   The highly likely change in the Executive Branch will also slow down any potential
changes. However, the Partnership is committed to establishing contact with the
new Executive leadership team as soon as possible in 2021.
3.   The Partnership will commission an updated Avelere report, available in 2021,
that has been particularly important in past years to convince the Legislature that the protected
class policy has no impact on prescription drug costs. Changing the policy could cause
serious disruption in the ongoing mental and physical health of protected class patients.

THE NATIONAL COALITION FOR TRANSPLANT EQUITY (FORMERLY CODE)

Billy Wynne, the long-time manager of CODE and the NCTE, recently sent out two important emails with information about transplant and donation activities.
The Government Accounting Office (GAO) issued a report that discusses the changes in organ allocation policy that UNOS has implemented in the past several years. An important part of this report concludes that the policies that UNOS created for this change were created in a very fair and open manner, with a great deal of community input from the professional groups to the interested public groups.
Changes continue to be made to allocation policies across all the solid organ categories. The latest changes will come in December 2020, with the elimination of geographic borders for kidney, pancreas, and kidney-pancreas distribution. Changes have already been implemented for heart, lung, and liver allocation.
As an adjunct to the GAO report, UNOS also released a report recently that cites an incremental increase in liver transplantation because of the new liver allocation activities that began about one year ago. These changes reflect the importance of the Final Rule in UNOS’s allocation policies.
Mr. Wynne reported on legislative activities for the funding of organ donation and transplantation programs and activities. The Senate Appropriations Committee released a package of spending bills for 2021 that impact transplantation. This package is generally used in negotiations with the House leading up to approval of spending programs.

Don’t hesitate to contact TRIO-Oklahoma Public Policy Committee with your questions and comments.

TRIO-Oklahoma’s committee on advocacy and public policy will discuss issues of importance to transplant patients and then post advocacy and public policy information on this page. We greatly value the input of all TRIO-Oklahoma members.