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 for August/September, 2021

Continuous Distribution

The allocation and distribution system used by UNOS has always been subject to conflicting principles with respect to meeting the requirements of the UNOS Final Rule.  This Rule directs UNOS to allocate any organ under its care to the patient who needs it the most, who is the sickest, or who may have been waiting the longest for the life-saving call to receive a transplant.

In the past, there was medical necessity that organs needed to be allocated to someone closest to the donor hospital because time from recovery of the organ needed to be minimized.  While that is still an important factor, organ characteristics and transportation improvements have now minimized that one factor as the most important consideration.

Circles were drawn around a donor hospital and then patients were grouped within those circles for medical urgency and other considerations.  If there was no one within a circle waiting for that organ, the circle size was increased and the search continued.  While much of this process could be automated in the UNOS systems, there was still much interaction between donor hospitals, OPOs, and transplant centers to finalize the decision.  This interaction requires time, and time is one of the enemies of successful organ transplantation.

How did UNOS address these issues?  In the past several years, UNOS and its various committees have spent much time and published many white papers to improve the allocation and distribution system.  The result of this effort, with a great deal of input from the public, medical ethicists, and practitioners in the transplant community, is a concept called continuous distribution.

The idea is quite straightforward.  Take all the decisions that are needed to determine the final outcome of an allocation, group these decisions by category, assign weights of importance to these categories, calculate a score for each person on the waiting list, and then come up with a result, a number on a list, where the number indicates the person with the highest score.  This person receives the organ at that point in time.   The categories can be different for each organ; the weights of each category can be different for each organ.  The calculation proceeds based on the organ or organs in the case of a multi-organ transplant.  This gives the transplant to the person with the highest, most needy, score, and fulfills the requirements of the UNOS Final Rule.  For sure, the travel distance from the donor hospital to the transplant center is still a factor, but it’s not the most important point to start to get an organ to the sickest or most needy person on the waiting list.

UNOS has already started to implement the concept of a continuous distribution system.  The first organ to fall under this new process are lungs; soon, kidney and pancreas will follow; then liver and intestine; and finally, heart and VCA transplants.

There is much more information on the UNOS website (www.unos.org) about continuous distribution.    Here’s that system page offering clear current vs. new system descriptions: https://optn.transplant.hrsa.gov/governance/key-initiatives/continuous-distribution/ There is also a very informative video about this  that can be found at the following link: https://unos.org/news/innovation/building-more-flexible-system-for-organ-allocation/  And lastly, UNOS continues to ask for public comment on the continuous distribution proposals and while TRIO as a national organization plans to make comments, individual chapter and individual members are also free to make comments.   The following is a link that explains that process and how best to make those comments:  https://unos.org/news/community-update-continuous-distribution-policy-development/

COVID Booster Shots

New information about Covid Vaccines and the booster shot for transplant patients and the general population seems to come out daily.  The CDC recently published a release which lays out  the Administration’s general plan for booster shots.  That release can be found at: https://www.cdc.gov/media/releases/2021/s0818-covid-19-booster-shots.html  The FDA also recently published a good summary of Covid information that can be found at: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19

An excellent summary of general information for transplant patients can be found in the special TRIO Newsletter of August 13.   That summary notes what continues to be the principal takeaways from all of the new information:

 

-Check with your transplant team before getting a booster shot as they know and understand your current condition best.  And do not change any of your current medications until you have checked with your team.

 -Continue to practice all of the Covid Prevention strategies including especially wearing masks, washing hands, avoiding crowds, and practicing social distancing.

Additionally, Penn Medicine recently published a very helpful and informative chart that lays out the Covid risk levels of various activities.  That chart can be found at: https://www.pennmedicine.org/-/media/documents%20and%20audio/print%20collateral%20documents/covid%2019/covid19%20risk%20index%20document.ashx  The CDC also recently published a very helpful article on precautions that are helpful where family members are either unvaccinated or not fully vaccinated which is at: https://www.cdc.gov/coronavirus/2019-ncov/your-health/about-covid-19.html

Part D

TRIO continues to participate in the Part D Coalition to maintain the six protected classes for drugs, which includes immunosuppressive drugs under Medicare Part D.   The Coalition has largely been focusing on the education of Congressional staff on the importance of the six protected  This has mostly been done virtually although in-person meetings should resume as the Covid situation resolves.   The Coalition recently called for quotes from users on the importance of the six protected classes from a patient perspective, and TRIO Oklahoma members provided many valuable quotes.

 Regional Meetings

UNOS holds Regional Meetings twice each year in the during the summer and winter months.   Participation is open and your public policy committee members have attended the regional meetings for their region.  We plan to provide a summary  overview of the discussions from those meetings and from future meetings in upcoming reports and newsletters.  These meetings are an excellent way to learn about and to make public comment on policy changes and proposals and to provide perspective to UNOS directly from the transplant community.

You can learn more about the particulars of the meeting in your Region,  including an agenda and  matters open to public comment by visiting:  https://unos.org/community/regions/regional-meetings/

Kidney Community Advocacy Day

For the past several years the American Society of Nephrology has organized a Kidney Community Action Day.  This day involves visits to Congressional and Senate offices to advocate on behalf of the 37 million Americans living with kidney disease.  TRIO has been among the 15 plus patient and heath professional organizations and 100 advocates taking part in this event and we will participate again this year.  This year the activity will take place of September 22.  The visits will not be in person but rather virtual this year.   TRIO and the other patient organizations will bring the first-hand patient, personal, and family perspective, and advocate for a broad range of federal action, such as maintaining and expanding Medicare coverage and supporting the expansion of transplant availability.   We will provide a report and update of these activities in our October public policy report.

All Transplant Patients and the Reconsideration of Social Security Disability 

Medicare eligibility, disability and reconsideration can be a complicated process because of the many variables especially timing concerns.  We will try to highlight a few of the matters over the next several months.

You lose your Part D drug coverage a month before Medicare expires if you go back on disability. You can choose to continue and pay for Medicare and Part D if you specify both in your letter asking for reconsideration. During a reconsideration process a person has 10 days to send a letter to the local office to ask for continuation of payments and / or Medicare. Note if you are declared no longer disabled you may have to pay back payments but will not have to pay back Medicare.  The key is the 10-day period asking to continue Medicare; if this does not happen Part D will discontinue one month prior to Parts A and B of Medicare. The payment schedule for Parts A & B are applied the month after for the previous month, for example August payment is for July, triggering Part D to terminate one month prior. Putting patients with comorbidities at risk.

Below are things to consider:

Challenges 

·         Medical appointments and procedures are a challenge

·         Billing issues and confusion to the patient.  

·         Hospitals and insurance companies deal with this daily; individuals do not. 

Remember

  • Read ALL the information
  • Communication with the Part D provider -If you communicate that you are going through a reconsideration with Social Security, they may consider extending Part D until there is a decision
  • Medicare Parts A & B continue for a month after Part D termination
  • ALL Transplant patients go through a reconsideration process and every patient is different.

Options 

  • Continue Medicare – 10-day period without SSDI payments but will come out of pocket

·         Marketplace- for insurance 

Please feel free to contact the public policy committee if you have had a particular experience or are aware of special circumstances  with the reconsideration processes that you think could be helpful for members of our transplant community to be aware if  they ever face a similar situation. 

TRIO Public Policy Committee report for July, 2021

Covid Vaccine Effectiveness

The Public Policy Committee continues to follow developments and ongoing study in the area of Covid vaccine effectiveness particularly as it relates to 3rd doses or booster shots for the immunosuppressed patient. The Public Policy committee wants to make absolutely clear in all venues that neither the committee nor TRIO is providing medical advice but rather information only and that all transplant patients should consult with their transplant team in all matters relating to Covid medications and vaccine course of treatment. The Committee prepared an article summarizing the results of a preliminary study done by John Hopkins on a small patient group. That article appears in the July newsletter Part 1 and is set out below.

Information about COVID vaccines and effectiveness

As part of our continuing efforts to keep our members informed about developments in the study of COVID vaccine effectiveness, we are sharing information about a recent study conducted by Johns Hopkins as part of its ongoing research on the vaccines for transplant recipients. This published report studied a small group of transplant recipients who received a third dose of COVID vaccine. This report is very preliminary and it cannot be stressed enough that all transplant recipients, caregivers, and family should continue with the safe social practices that have been necessary since the beginning of the pandemic: maintaining social distancing, wearing masks, maintaining personal hygiene, and being aware of surroundings.

There were 30 patients in this study: 6 patients had positive antibodies after the 2 shot regimen of Moderna or Pfizer, and 24 had no antibodies after the 2 shot regimen. After the third shot was given, the 6 who started positive went to high positive, 6 of the 24 who started negative went to high positive, 2 of the 24 went to low positive and the rest of the 24 stayed negative.

There are several major points to emphasize with this report for our community:

-This is not a formal study with a significant sample size. In fact, the report emphasizes that more rigorous study is necessary.

-As in the previous studies from Johns Hopkins, there is no information about all of the components of the immune system, namely T cells and B cells. Likewise there is no discussion of links between particular immunosuppression regimes and vaccine response.

-The patients in the study received different transplants but the large majority were kidney recipients.

All of these factors emphasize the need for further study. We will be sharing further information about this Johns Hopkins study as it becomes available as well as information from other studies which are underway at other institutions regarding 3rd vaccine doses and transplant recipients. Our purpose is to provide ongoing information not medical advice. As always please be sure to check with your transplant team before making any change or addition to your COVID medication and vaccine course of treatment.

The full report on this Johns Hopkins study is available at https://www.acpjournals.org/doi/10.7326/L21-0282

Comments on changes to the Medicare Payment System

The Centers for Medicare and Medicaid Services (CMS) recently announced proposed changes to the Inpatient Prospective Payment System (IPPS). This is the payment mechanism by which Medicare sets payment rates to hospitals and providers for all Medicare covered inpatient services. The proposed rules particularly included changes to the payment rates for certain transplant services which have the potential to cause significant reductions in payment and the availability of organs for transplant. CMS published these proposed rules in the Federal Register and requested public comment on these changes and TRIO has responded with comments in two settings. First, TRIO responded directly to CMS with comments on the transplant related sections of the proposed rules. And second, TRIO joined with a large number of both patient and provider organizations in a joint letter with comments on those same sections. In both instances, TRIO requested that CMS refrain from making the proposed rules final or operational and rather engage in further study to more fully understand their effect on the transplant community and the potential for significant reduction in organ availability. The public policy committee will continue to monitor and report on the status of these proposed rules.

Release of The God Committee Movie

The film, The God Committee, is expected to be released in early July. The film is about a hospital committee which has to make a decision regarding the allocation of heart transplant to one of three potential recipients. TRIO is working with Donate Life Hollywood to share talking points which clarify the role that an individual hospital has in the allocation process and will work to ensure that information is available to ensure there is no misunderstanding about the process and clearly separate fact from fiction. The film could have the potential to cause concern about the donation and allocation process and the information to be developed by Donate Life Hollywood will help to assure the general population that the process is carefully monitored by numerous sources and is fair and equitable and that misinformation about allocation does not receive undo publicity as a result of the film. The public policy committee is fully committed to following up on the Donate Life Hollywood information by developing a TRIO paper which will provide a general overview of the donation an allocation process and specifically include information on the recently operationalized new UNOS rules on continuous distribution. The public policy committee will work to make that report available through this public policy report in the upcoming months.

Part D and the Six Protected Classes

The public policy committee continues to participate in the Part D Coalition to continue the Six Protected Classes of drugs which includes immunosuppressives. The committee is working with Venn Strategies which is now the new lead organization for the Coalition. That organization is developing plans for action with the Congress and the committee has committed to working with them as plans firm up and possibly include visits to Washington DC to meet with Congressional staff. More information should be available in the near future.

Living Donor Protection Act

The LDPA continues to work through the Congressional process and is in committees in both houses of Congress. It continues to gain cosponsors on the Senate side. TRIO remains committed to providing any further information and responding to any request from legislators regarding the Act.

Honor the Gift

TRIO continues as a member of the Honor the Gift Coalition but has no particular update for the month of June. The Coalition, however, does continue to want to remind everyone that while there was the great success of the passage of the legislation it does not become effective until 2023 and all should be aware of that timing. Reports of Coalition activities and updates will continue as the process continues.



TRIO Public Policy Committee report for June, 2021

COVID-19 Vaccine Effectiveness in Transplant Patients

 * RESEARCH CONTINUES – STAY TUNED *

 In May 2021, Johns Hopkins published the results of a study with transplant recipients who had received both mRNA vaccinations (Pfizer or Moderna).  The study shows that the vaccines are effective in only about half of immunosuppressed individuals – significantly less than in the general population.  Other studies have also shown that these vaccines are less effective for transplant recipients.  TRIO has been following this changing issue closely as research results come in.

 TRIO endorses the American Society of Transplantation expert recommendations that you can find at: 

https://www.myast.org/statement-covid-19-vaccination-solid-organ-transplant-recipients#

 TRIO offers the following summary guidance in line with what is known today:

1. DO get vaccinated with any of the three approved vaccines as soon as possible, and make sure your caregivers and families get vaccinated to reduce your risk.

2. DO continue to practice the CDC recommendations of safe distancing, wearing masks, and washing regularly.

3. DO seek your transplant team’s advice, understanding that they too are receiving evolving results from studies, but they are staying on top of the latest findings and providing individualized advice for each of their patients as findings are released from ongoing research studies.

 Here’s more of what we know now:

1. Research continues with daily news of new discoveries.

2. There are three parts of our immune system but to date we have seen results only from the study of the antibody part of those three (therefore we have limited knowledge about the full extent of vaccine effectiveness in people who don’t develop high antibody levels after vaccination) .

3. It is not known what level of antibody production is an effective level, so at this time experts are NOT recommending (despite some individuals speaking to the contrary) that patients get antibody testing.

4. At this time, experts are NOT recommending patients undergo a third vaccine shot (again, due to the unknown nature of the level of antibodies needed for protection and how the other two immune system parts play into this).

 For more information and to get an idea of the extent of the research and studies here are links to some recently published information:

 Journal of the American Medical Association:

https://jamanetwork.com/JOURNALS/JAMA/FULLARTICLE/2777685

 

SIX PROTECTED CLASSES EFFORTS CONTINUE

Thorn Run Partners, in Washington, has been the long-standing group leading the efforts for many years to maintain the Six Protected Classes provisions under Medicare.  For almost 10 years, Thorn Run, through Catherine Finley and her team, has written position papers, coordinated legislative briefings and visits to Congressional leaders and staff, and kept alive the importance of maintaining unfettered access to prescription drug regimens for the affected classes of patients.

Recently, the Partnership for Part D Access has engaged a new Washington team at Venn Strategies with a team of 5 people, led day-to-day by Chris Fox.   The Partnership is the consortium of pharmaceutical companies and patient grassroots organizations who came together at the very first moment when the Six Protected Classes provisions were being attacked.  Venn is currently creating a position paper to present to the Partnership outlining plans moving forward.  Venn said this paper should be ready for viewing at the next meeting of the Partnership in June, 2021.

The Thorn Run team deserves an enormous round of thanks for its efforts.  The team successfully managed the Partnership through many years of attempts at the legislative and executive branch level to reduce and even eliminate the protected class provisions.   The Thorn Run team led the members of the Partnership to successfully rebuff every attempt to dismantle the 6 PC program.  Thanks to Catherine Finley and her entire team at Thorn Run.

 

 

TRIO Public Policy Committee report for 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

 

PUBLIC POLICY REPORT AND CALLS TO ACTION FOR 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/   

 

PUBLIC POLICY COMMITTEE REPORT FOR NOVEMBER 2020

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 This email address is being protected from spambots. You need JavaScript enabled to view it., Ira Copperman at This email address is being protected from spambots. You need JavaScript enabled to view it. or Lorrinda Davis at This email address is being protected from spambots. You need JavaScript enabled to view it.. 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 COVID19 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


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.