TRIO PUBLIC POLICY REPORT – December 2021
CMS Request for Information (RFI)
CMS (Centers for Medicare & Medicaid Services) recently published a Request for Information (RFI). The request seeks input on changes to improve the organ transplant and donation system and both access to dialysis services and better quality of care in those dialysis facilities. The request also asks for input on how to reduce racial and disability inequities in the transplant system. Because of the wide-ranging scope of information requested, CMS is seeking input from all stakeholders such as OPOs, ESRD facilities and dialysis providers and hospitals and very importantly is seeking input from transplant recipients and families and organ donors and families. They are soliciting comments on ways to:
1. Continue to improve systems of care for all patients in need of a transplant; 2. Increase the number of organs available for transplant for all solid organ types; 3. Encourage the use of dialysis in alternate settings or modalities over in-center hemodialysis where clinically appropriate and advantageous; 4. Ensure that the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) policies appropriately incentivize the creation and use of future new treatments and technologies; 5. Harmonize requirements across government agencies to facilitate these objectives and improve quality across the organ donation and transplantation ecosystem.
And are looking for this information in specific settings including Transplant Centers, ERSR facilities, Nursing Home Dialysis, Mobile Dialysis, and OPOs. However, in all of these areas they are including patient impact and the need for patient and family comment. Some particular areas for patient comment are noted especially including transplant center patient safety performance, satisfaction with care, quality of patient education, waitlist transparency and experience with organ offers.
TRIO will be preparing comments on this RFI as a national organization but the RFI is specifically requests public comment and all TRIO members and Chapters are of course able to comment. Those comments will be due by February 1, 2022 and the formal request for comment can be found at https://www.federalregister.gov/d/2021-26146. Individual members and Chapters are encouraged to share their comments with the Public Policy Committee or share their thoughts with the Committee for inclusion with the TRIO National comments.
Update on COVID Prevention and Treatment
In just the past several months, there has been an explosion in the treatment and prevention options for COVID-19, especially relevant to the immune compromised community.
There are now several approaches to protection including the following:
Vaccination – this must always be done regardless of any other choices. The new news is that 3 doses spaced apart is the standard of treatment, followed by booster dose, either half-dose (Moderna) or full dose (Pfizer). Also, there is evidence that vaccines can be mixed between manufacturers (3 doses of Moderna followed by a booster dose of Pfizer, for example). The guidance is to get vaccinated with what is available.
Virus avoidance – this includes masking, distancing, avoiding crowds, and handwashing.
Prophylactic prescriptions – Monoclonal antibodies (MABs) are an option for some immune compromised patients. Evusheld (an MAB combination) may be appropriate for some transplant recipients pre-exposure to COVID; Regen-Cov (a different MAB combination) may be appropriate for some transplant recipients recently exposed to COVID.
Treatment with MABS, anti-virals, anti-inflammatories, and /or convalescent plasma – Some transplant recipients with mildly symptomatic COVID are candidates for MABS (there are several options) and/or anti-viral pills (there are several options), Other recipients who are hospitalized with more severe COVID may be candidates for MABs, intravenous anti-viral medications, anti-inflammatory medications, and/or convalescent plasma.
This is a fast-changing landscape; for the best information regarding prevention and treatment options, keep up to date through the NIH or CDC websites. Make sure you consult your medical care team for personalized care recommendations.
NIH information can be found at the following link: https://www.covid19treatmentguidelines.nih.gov/ The CDC website is at the following link: https://www.cdc.gov/coronavirus/2019-ncov/communication/guidance.html
In addition, here’s a pointer to a very good article that explains the difference between the various kinds of COVID testing options, meaning the PCR test and the Rapid test: https://www.huffpost.com/entry/covid-19-test-what-to-take_l_6127927ae4b06e5d80ca7136
TRIO continues to actively participate in the Part D Coalition the goal for which is to preserve the six protected classes of drugs under Medicare. Those protected classes currently include a class for immunosuppressive drugs which obviously crucial for transplant recipients. The Coalition has recently been developing one-pagers on each of six protected classes for use in discussing the need to continue this benefit with Congressional staff. The various organizations which benefit from the current coverage have been working with Coalition staff to finalize these documents and TRIO has been part of this effort. These documents of course can have much broader educational uses. Once they are finalized the public policy committee will be sure to share the transplant drug one-pager with everyone for use as a resource.
UNOS Calls for Action on the Living Donor Protection Act (S.377/HR.1255)
UNOS is asking the public to show their support for promoting living organ donors. This bill, introduced by Senator Gillibrand and Representative Nadler, has outstanding bi-partisan support in the congress. Even though the act will expire on 12/31/2021, look for it to be introduced again in the next congressional terms. TRIO fully supports this UNOS call to action which is outlined below and you can very easily contact your representative with the included link.
UNOS call to action: Ask Congress to support the Living Donor Protection Act NOW! The Living Donor Protection Act will expire on Dec. 31! Help us get it through Congress by asking your representatives on Capitol Hill to lend their support. Here is the link to contact your member of Congress: https://p2a.co/V4FLUkR
In 2020, despite the pandemic, there were 5,726 living donor organ transplants. Unfortunately, living donors sometimes face discrimination when seeking life insurance, disability insurance, or long-term care insurance. The Living Donor Protection Act would establish protections for living donors to make sure they don’t face these hurdles. With living donor transplants down more than 23% during the COVID-19 pandemic, this legislation is more important than ever before. If you have questions about our new advocacy program, please contact Kelly.Roberts@unos.org. Thank you for all that you have done and all that you continue to do to serve the community.
Update on Continuous Distribution
The Public Policy Committee is actively following UNOS’ ongoing efforts to develop and implement a new and more equitable allocation system for deceased donor organs. That new system called the continuous distribution system will align the distribution system with the OPTN final rule. Broadly the new system will provide new mechanisms for balancing medical urgency, distance from the hospital, donor and recipient compatibility and survival. The Public Policy Committee is working to develop an article which will provide an overview of how the system will work as UNOS rolls out plans for each organ. We did want to report that UNOS in the last week announced the continuous distribution plan for lungs which may be implemented in 2023. The committee will continue to follow these activities and plan to provide an overview report within the next few months.
TRIO Public Policy Report – November 2021
TRIO LEGISLATIVE OUTREACH ACTIVITIES
Patient advocate groups continue their efforts to stay ahead of congressional and executive branch efforts to change prescription drug therapies. This is particularly true as the pressure mounts on controlling the cost of prescription drugs by imposing severe restrictions on access to drugs by patient communities like transplant recipients.
Grassroots organizations, like TRIO, continue to respond to the requests to add their voices on behalf of any affected group. Two recent efforts demonstrate how TRIO and many other organizations are participating to keep prescriptions open and available.
Safe Step Act (S.464/H.R.2163)
A bi-partisan coalition of House and Senate members has taken up the cause for one of the insurance industry’s most onerous provisions, the issue of step therapies. This is a way that the insurance industry approves the use of the cheapest prescription drug first until it’s proved either non-working or worse, harmful. A more complete discussion of step therapies can be found at the following website:
The Senate and House Acts create a specific set of protocols that require insurance companies to accept prescriptions even if there are cheaper varieties. One of the five protocols is that the patient is stable on the current prescription regimen. The other four protocols are equally important to the protected classes.
This bill has just been introduced into the Congress; we’ll keep you posted as it progresses through the congressional process.
Mental Health Needs and Protections
Senators Crapo and Wyden from the Senate Finance Committee solicited input from the mental health community on ways the Congress should focus on addressing its needs. The mental health community has been an integral part of the efforts to maintain the Part D 6 Protected Classes (6PC) provision since the beginning of the efforts to change the 6PC almost 10 years ago.
The National Council on Mental Wellbeing, with assistance from Venn Strategies, sent a letter to the Senators Wyden and Crapo asking for continuation of the 6PC provisions as a major step in the mental health efforts in the United States. More than thirty grassroots organizations, including TRIO, co-signed this letter as an indication of our support for and solidarity with the mental health proponents. There will be more activity in the coming months; we will continue to keep you informed as these legislative efforts continue.
Within the past several weeks, extraordinary activity has occurred
with xenotransplantation. Dr. Robert Montgomery and his team
from the NYU Langone Transplant Institute in New York City led a
ground-breaking effort to get a fully functioning pig kidney to work
successfully in a human subject, a brain-dead donor who had consented
to organ donation research.
The American Association of Kidney Patients (AAKP) interviewed
Dr. Montgomery recently and put the interview on the AAKP website.
You can watch the entire interview on YouTube at the following link:
BUILD BACK BETTER ACT
The Build Back Better Act which has been passed by the House and is currently under consideration by the Senate includes many health care related provisions including changes to Part D, additional Medicare benefits including a hearing benefit and changes to drug pricing. It is not clear which provisions may be included in any final bill and how or if they may be changed from current House language during negotiations with the Senate. The Public Policy committee will continue to closely monitor the status of the Act and will report on those provisions which become law and will impact our transplant community.
FDA APPROVES NEW DRUG FOR CYTOMEGALOVIRUS
The FDA recently announced its approval for a new drug to treat Cytomegalovirus (CMV). This new drug is named LIVTENCITY and is produced by Takeda Pharmaceutical. CMV is one of the most challenging opportunistic infections post-transplant and this new drug will greatly benefit transplant recipients over the coming years. CMV infection can significantly increase the risk of transplant rejection, graft failure and mortality, as well as result in longer hospitalization and transplant costs. Additional background on this drug and the potential impact on the transplant community can be found in a news release at the following link:
TRIO Public Policy Report – October 2021
TRIO along with numerous other patient organizations recently signed on to a letter sponsored by the HIV and Hepatitis Policy Institute to the Senate Finance Committee. The Congress is currently considering numerous proposals around drug pricing and this letter supports those that would clearly help improve prescription drug affordability and access for patients. The specific proposals that the letter supports include:
-A cap on annual out of pocket costs for Medicare Part D.
-Creation of a smoothing mechanism in Medicare Part D that would allow for payment of out-of-pocket costs throughout the year rather than all at once.
-Pass rebate savings on to patients by basing cost-sharing on post-rebate prices rather than on drug list prices.
-Ensure commercial insurance benefit design does not discriminate against vulnerable beneficiaries by placing undue cost sharing on sharing on patients.
-Ensure patient copay assistance counts toward beneficiary deductible and out of pocket expenses.
The letter further urges the Congress to further study and not take immediate action on any proposals that would authorize direct pricing negotiations with companies or would adopt some type of international pricing standards as in the short term they could impact access to especially newer drugs or those for rare conditions.
Covid Booster Shots
News about new developments continues to appear almost daily and 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.
For information specific to transplant patients the committee does recommend a fairly recent CareDx sponsored presentation on the Delta Variant and Covid 19 for Transplant patients that can be viewed at: https://caredx.zoom.us/webinar/register/6016295854708/WN_NINy43_ZS9-lnWs0amXYBg
UNOS Regional Meetings
UNOS holds Regional meetings twice every year (called summer and winter meetings). The summer meetings for 2021 were just completed at the end of the September. These meetings bring together the members of UNOS in each region, including OPOs, transplant centers, transplant laboratories, and the public. The regional meetings are open to anyone; there is a very structured day of presentations and regional votes by members on UNOS committee proposals. The public doesn’t vote on proposals, but is strongly encouraged to provide input into the UNOS public comments section of the website (www.unos.org).
The Public Policy Committee encourages all members to consider attending a meeting either virtually or in person when that resumes. The recipients’ perspective is unique and always welcomed at the meetings. More information on the specific regional meetings and the scheduling of the winter meetings is available on the UNOS website at https://unos.org/community/regions/regional-meetings/
While each Region can have its own unique perspectives the agendas are largely the same. The UNOS website includes information specific to each Region. The following is a summary of the recently held Region 9 summer meeting prepared by Ira Copperman who is a committee member. Again while specific to that Region it touches on all of the points discussed generally at each of the meetings.
The latest Region 9 meeting took place on August 12, 2021. There were specific presentations from each organ committee, along with 3 very important additional presentations on the following:
Committee activities on the various continuous distribution implementation programs
UNOS policy initiatives on improving programs for matching donors and recipients
Changes to the measurement system that UNOS uses for monitoring OPO and transplant center performance
Earlier in August, the Membership and Professional Standards Committee (MPSC) hosted a separate meeting to report on the efforts behind the changes being evaluated for OPO and transplant center performance. The changes being proposed can be found in a white paper published by the MPSC Committee. Additional information about the Region 9 meeting, including presentations and the voting results, can be found at the following websites: https://unos.org/community/regions/region-9/
Update on Continuous Distribution
The first organ to use the continuous distribution algorithm is the lung. In the summer of 2021, UNOS issued a position paper for public comment. The public comment input period ended on October 1, 2021. The lung allocation committee will review all comments and issue a paper to the UNOS Executive Committee. Once approved by the Committee, implementation will begin, with the expectation to be completed within 12 months. The Committee provided general background on the Continuous Distribution implementation process in its September report. Organ allocation based on continuous distribution assigns a score to a waiting list recipient based on a formula with weighted parts. Each organ can have a different set of weighted parts and the weighted parts can be assigned different percentages. For example, distance from donor hospital to transplant center might be the most important piece part. In another case, time on the waiting list might be the most important aspect. And for another organ, cold ischemic time, which is the amount of time when blood flow to the organ from the donor is stopped and blood flow from the transplant recipient begins, may be the most important aspect.
The Final Rule can be found in the Federal Regulations at 42 CFR 121.8. A very good explanation of the Final Rule can be found at: https://journalofethics.ama-assn.org/article/national-organ-allocation-policy-final-rule/2005-09
TRIO Public Policy Committee report for August/September, 2021
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
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.
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:
- 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.
- 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.
- 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.
National 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.
National Public Policy Report 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:
TRIO offers the following summary guidance in line with what is known today:
- 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.
- DO continue to practice the CDC recommendations of safe distancing, wearing masks, and washing regularly.
- 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:
- Research continues with daily news of new discoveries.
- 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) .
- 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.
- 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:
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
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.
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.
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 firstname.lastname@example.org, Ira Copperman at email@example.com or Lorrinda Davis at firstname.lastname@example.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
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.