Legislation & Regulatory Updates

AST is your voice and seat at the table on Capitol Hill, within the Executive Branch, Federal Agencies and in many state capitols and legislatures. These governmental agencies dictate and have direct oversight of most aspects of transplant patient care and medical research. From clinical to research, the field of organ transplantation is heavily regulated and frequently addressed by both our elected and un-elected federal and state leaders.

AST maintains a strong bipartisan and bicameral presence to educate, cultivate and mobilize support for the Society's public policy agenda. Members of Congress, their staff, and senior HHS officials know the Society well and work with its members and the Washington, DC, government relations staff on a daily basis.

OPTN/UNOS Corner

Twice a year, the Organ Procurement and Transplant Network (OPTN) releases proposed new policy for public comment (http://optn.transplant.hrsa.gov/governance/public-comment/). Members of the transplant community and the interested public are encouraged to provide feedback on the proposals. As part of its larger advocacy goals, the American Society of Transplantation reviews the policies and provides feedback, where appropriate. The Society seeks input from key constituencies to inform our commentary as follows:

1. The AST OPTN/UNOS Policy Committee Chair reviews each proposed policy released for comment to identify specific Communities of Practice (COP) or Committees to review the proposals and suggest comments. 
2. COPs and/or Committees develop suggested comments that they forward to the AST's OPTN/UNOS Policy Committee. Any COP may draft a reply for consideration, even if not identified as a key reviewer. Notification is also put out to the general membership.
3. The AST OPTN/UNOS Policy Committee reviews all of the comments and feedback received in order to generate a single comment for each policy that shares specific thoughts or concerns and states the position of the Society where appropriate.
4. The AST OPTN/UNOS Policy Committee Chair presents draft responses to the Board for approval or amendment before submission to the OPTN. 

AST comments on OPTN/UNOS Policy Proposals:

• September 18, 2023 comments on 15 proposals
• January 19, 2023 comments on 12 proposals 
• September 28, 2022 comments on 15 proposals
• March 23, 2022 comments on 14 proposals
• September 29, 2021 comments on 15 proposals
• March 23, 2021 comments on 9 proposals
• October 1, 2020, comments on 11 proposals
• March 23, 2020, comments on 11 proposals
• December 5, 2019, special public comment period on 1 proposal
• November 14, 2019, special public comment period on 1 proposal
• October 1, 2019, comments on 8 proposals
• March 22, 2019, comments on 10 proposals
• October 31, 2018, special public comment period on 1 proposal (11/9/18 - The AST Board has issued a statement on this public comment)
• October 1, 2018, comments on 6 proposals
• March 8, 2018, comments on 15 proposals
• January 30, 2018, special comment period on 1 proposal
• October 2, 2017, comments on 13 proposals
• March 25, 2017, special comment period on 1 proposal
• January 23, 2017, Comments on 6 proposals
• October 11, 2016, Comments on 15 proposals
• March 23, 2016, Comments on 9 proposals and one concept paper

Archived Updates.

AST Feedback on Pending Legislation

• AST partnered with 27 other healthcare organizations in a letter to Congressional leadership in support of the Living Donor Protection Act of 2023 (H.R. 2923/S.1384) (May 2023)
• The AST joined over 120 organizations in a letter to Congressional leadership in support of the Hepatitis C elimination plan. (April 2023)
• The AST and ASTS partnered in an open letter to Congress to seek a change in regulatory oversight for pancreatic islets. (Feb 2023)
• The AST responded to a request for information from Rep. Richard E. Neal (D-MA) regarding the issue of racial bias in clinical tools used in the field of organ transplantation. (Dec 2020)
• The AST, ASTS, and AAKP sent a letter to key members of Congress to share ongoing concerns regarding the H.R. 8254/S.4574, the “Bringing Enhanced Treatments and Therapies to ESRD Recipients” (BETTER) Kidney Care Act. (Nov 2020)
• The AST and more than 20 other organizations signed onto a Transplant Roundtable letter encouraging swift action on S. 3353, the Comprehensive Drug Coverage for Kidney Transplant Patients Act, during the 116th Congress (August 2020)
• The AST, ASTS, and AAKP sent a letter to Senate leadership to request the swift passage of S. 3353, the Comprehensive Drug Coverage for Kidney Transplant Patients Act, during the 116th Congress. (July 2020) 
• AST partnered with AAKP and ASTS on a joint letter of strong support for the Energy and Commerce Committee's Markup of H.R. 5534, the Comprehensive Drug Coverage for Kidney Transplant Patients Act. (July 2020) 
• The AST endorsed efforts by Sen. Baldwin (D-WI) in a letter to applaud her introduction of S. 3584, the Workers First Protection Act. The bill seeks to the issuance of a comprehensive emergency temporary standard to protect workers against the COVID-19 pandemic (April 2020)
• The AST drafted a letter to the Majority and Minority Leaders regarding the critical need for PPE and other resources to effectively combat the COVID-19 virus (April 2020)
• The Society joined more than 200 other organizations in a letter to the Administration asking for immediate action to alleviate the critical shortage across the nation of ventilators and personal protective equipment resulting from the COVID-19 pandemic (April 2020).
• The AST Joined a number of organizations in a letter to request significant long-term investment in public health infrastructure that is critical to support the public health system as it rebuilds from the COVID-19 crisis and prepares for future public health demands (April 2020).
• The AST joined the kidney community in signing a letter to leaders of the House and Senate Appropriations Committees. The letter requests and increase for the National Institutes of Health (NIH) of $3 billion above the FY 2020 level of funding, including a robust increase for the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) that is at least proportional (March 2020).
• The AST signed on to a stakeholder letter sent to all 435 Members of the House of Representatives on January 7, 2020, in support of H.R. 5534, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019. The Society awaits Senate introduction of this important legislation.
• The AST joined more than 20 other signatories in continuing to voice concerns related to the Dialysis PATIENTS Demonstration act to both House and Senate (October 2018).
• The AST partnered with AAKP, ASN, and ASTS on a joint letter of continuing concern related to an updated draft of the Dialysis PATIENTS Demonstration Act of 2017 (revisions to H.R. 4143) and its impact of access to kidney transplantation. (October 2018)
• The AST joined other partners in the transplant community in drafting a letter of thanks for inclusion of the Veterans Transplant Coverage Act of 2017 and elements of the Veterans Increased Choice for Transplanted Organs and Recovery (VICTOR) Act in VA MISSION legislation, offering additional assistance in helping the VA develop an open and transparent process to ensure that veterans are given choices and opportunities for organ transplantation. (May 2018)
• The AST drafted a letter of support for the Veterans Increased Choice for Transplanted Organs and Recovery (VICTOR) Act (January 2018)
• The AST joined other partners in the transplant community in drafting letters to the House and Senate regarding the Dialysis PATIENTS Demonstration Act of 2017. The Society continues to have significant concerns about the potential impact of this legislation on Medicare beneficiaries' continued access to kidney transplantation. (December 2017)
• The AST joined with other partners in the transplant community to draft a letter in support of the Veterans Transplant Coverage Act of 2017 (October  2017).
• The AST drafted a coalition letter regarding the issues of chronic care and pre-existing conditions as addressed in the current Repeal and Replace efforts ongoing in the US Senate. (September 2017)
• AST signed on to a coalition letter urging legislators to ensure that all members of the healthcare workforce with Deferred Action of Childhood Arrivals (DACA) status are able to continue their employment, education, training, and research, with passage of a permanent legislative remedy, such as the Dream Act of 2017 (September 2017)
• The Society signed on to a community letter expressing concerns regarding the FY2018 funding proposal for NIH, including drastic reductions to NIH support for facilities and administrative expenses. (August 2017)
• The AST signs a coalition letter of support for the Living Donor Protection Act (July 2017)
• AST signs joint letter noting concern related to Dialysis Patient Demonstration Act in addition to submitting our own letter on this topic (June 2017)
• The Living Organ Donor Protection Act of 2017 has been reintroduced by Congressman Jerrold Nadler and Congresswoman Jaime Herrera Beutler. (February 2017)
• AST signs joint letter regarding President Trump's immigration executive order. (February 2017)
• A letter noting concern related to the ESRD Integrated Care Act's negative impact on kidney transplantation.
• Helping Hospitals Improve Patient Care Act of 2016 (H.R. 5273) endorsed by the AST
• Living Donor Protection Act of 2016 - coalition letter spearheaded by AST and signed by more than 25 other organizations in support of this legislation that will  protect living organ donors from job loss and other discrimination
• Concerns regarding the MedPAC's suggestion to remove immunosuppressant medications from the category of "protected drug class" on Medicare Part C and D formularies

Archived Updates

Other Regulatory Updates

• The AST submitted a letter to both HHS and HRSA to offer its partnership in addressing the OPTN Modernization efforts (September 2023).
• The AST joined ASTS in a letter to HHS sharing comments regarding the 2024 HOPPS Proposed Rule (September 2023).
• The Society joined other stakeholders in the organ donation and transplantation community to request the inclusion of a provision in the next FAA reauthorization to promote efficient transportation of donated organs through the U.S. commercial aviation system. This would enable the transport of donated organs in the passenger cabin rather than the cargo hold of airplanes (June 2023).
• The AST submitted a letter to MolDX to seek clarification regarding its recent decision to limit reimbursement coverage for molecular diagnostics for transplantation such as donor derived cell free (cf)DNA and gene expression profiling (April 2023).
• The AST joined onto a multi-signatory Friends of HRSA coalition letter supporting the proposed FY2024 budget increase for HRSA programs (March 2023).
• AST submitted feedback regarding CMS-0057-P, a proposed rule regarding conveying information about prior authorizations for drugs (March 2023).
• The AST submitted a letter to HHS and CMS regarding the need for the continued advancement of biomarker research in the area of organ transplantation (December 2022).
• The AST and ASTS submitted a letter in response to the CMS proposed rule on the 2023 Medicare Hospital Outpatient Prospective Payment System "HOPPS" (September 2022).
• The Society submitted a Letter regarding medically necessary dental coverage of organ transplant patients in response to CMS-1770-P (September 2022).
• The AST submitted a response to the CMS RFI on Medicare (CMS-4203-NC) to share thoughts regarding living organ donation and transplantation provisions and organ transplant recipient medication access (August 2022).
• The AST and ASTS submitted a letter to the Secretary of the Department of Health and Human Services, Xavier Becerra, regarding the National Academy of Science, Engineering, and Medicine (NASEM) report, "Realizing the Promise of Equity in the Organ Transplantation System" (August 2022).
• The AST responded to CMS regarding CMS-4199-P: Implementing Certain Provisions of the Consolidated Appropriations Act and Other Revisions to Medicare Enrollment and Eligibility Rules, which lays the framework for implementation of the Immuno Bill (June 2022).
• The AST released a statement on the Supreme Court's overturning of Roe v. Wade (June 2022).
• The AST responded to HRSA’s request for information that seeks to strengthen and improve components of the OPTN contract as it works towards issuing a request for proposal for the next OPTN contract (May 2022).
• The AST signed on to letters to the House and Senate to seek support for additional COVID-19 relief funding to prioritize therapeutic purchasing and research for new treatments, including prophylactic therapies and antiviral medications that are much needed for immunocompromised individuals.
• The AST joined a number of other organizations in a multi-signatory response to CMS regarding a recent RFI, Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Recommendations, and Fee Regulations under the CLIA Amendments of 1988 (April 2022).
• The Society responded to a CMS Request for Information (RFI) on Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities (February 2022).
• The AST sent letters to Truven Health Analytics and the American Society of Health-System Pharmacists to request review of compendium content on a number of transplant-related drugs to request for expansion of "Non-FDA Uses" section to include off-label indications as listed (December 2021). 
• The AST signed on to a letter to the CDC encouraging the Clinical Laboratory Improvement Advisory Committee (CLIAC) to modernize CLIA regulations for laboratory developed tests (LDTs) (November 2021).
• The Society submitted a letter to the Advisory Committee on Immunization Practices (ACIP) to ask that access to a third dose of mRNA COVID-19 vaccine be strongly considered for transplant recipients (August 2021). 
• The AST joined nearly 50 transplant stakeholder organizations in a joint letter to Centers for Medicare & Medicaid Services (CMS) Administrator Brooks-LaSure in opposition to transplant policy proposals included in the recent 2022 Inpatient Prospective Payment System (IPPS) Proposed Rule (June 2021)
• The AST joined the Ad Hoc Group for Medical Research as one of nearly 350 signatories in a letter to President-elect Joe Biden, thanking him for his steadfast support for science in his Build Back Better plan. This includes NIH funding and his focus on ending the COVID-19 pandemic (Dec 2020).
• AST submitted a letter to Secretary Azar regarding opportunities for improvement in organ procurement organization performance metrics (September 2020).
• The AST submitted a letter to Vice President Pence, Ambassador Birx, and Secretary Azar urge that COVID-19 data collection and reporting be returned to the CDC rather than an external vendor (August 2020).
• The AST joined IDSA and a number of other signatories on a coalition letter to Vice President Pence, Ambassador Birx, and Secretary Azar to strongly recommend that the administration immediately reverse its decision to bypass the CDC in the collection and analysis of COVID-19 patient data (July 2020).
• The Society requested urgent assistance from the National Governors Association in providing critical supplies for access and prioritization of PPE and other critically necessary medical supplies need to fight the war on COVID-19 (May 2020).
• The AST submitted a letter to Vice President Pence regarding the need for transparent, equitable, and data-driven distribution of Remdesivir for emergency use in the treatment of patients hospitalized due to COVID-19 (May 2020).
• The AST responded to a HRSA notice on proposed changes to living donor reimbursements for travel and subsistence expenses (April 2020).
• The Society provided feedback to HRSA RFI on data collection for organ transplantation (April 2020).
• The AST signed on to a coalition letter recommending additional funding for discretionary Health Resources and Services Administration programs in the FY 2021 Labor, Health and Human Services, Education, and Related Agencies appropriations bill (February 2020).
• The Society submitted comments on a proposed rule by CMS to revise the Organ Procurement Organization (OPO) Conditions for Coverage (February 2020).
• The AST submitted comments on a proposed rule by HHS on Removing Financial Disincentives to Living Organ Donation (February 2020).
• AST joined other organizations on a stakeholder letter to HHS regarding access to dental care for transplant candidates and recipients (February 2020).
• The Society submitted comments on the RFI for Revisions to the PHS Guidelines on Reducing HIV, Hepatitis B, and Hepatitis C Through Organ Transplantation (October 2019).
• The AST and the ASTS submitted a joint response to CMS regarding proposed revisions of organ procurement organizations conditions of coverage (September 2019).
• The AST submitted a response CMS regarding its proposed ESRD Prospective Payment system and its connection to kidney transplantation (September 2019).
• AST joined other organizations in a letter to CMS voicing concern regarding beneficiaries' barriers to accessing off-label treatments in Medicare Part D (September 2019).
• The AST submitted two memos to CMS to voice concerns related to new Transplant Center interpretive guidelines. One memo is specific to concerns related to the independent living donor advocate and the second includes comments and concerns related to a number of specific guidelines. (July 2019)
• AST President Emily Blumberg joined a number of other kidney patient advocates and health professionals on July 10, 2019, in Washington DC to watch President Donald Trump sign an executive order aimed at improving kidney health.
• The  Society sent a letter to Truven Health Analytics/IBM Watson Health requesting a review of Micromedex DRUGDEX content on a number of transplant-related drugs with a request for expansion of "Non-FDA Uses" section to include off label indications as listed. (April 2019)
• The Society joined a number of other kidney patient advocates and health professionals in a coalition letter to request increased funding for the NIH in 2020, including an increase for the NIDDK and a Special Statutory Funding Program for kidney research. (Mar 2019)
• The AST joined a number of other organizations in sending letters to CMS to voice concern related to a change in the codes that significantly reduced DRG reimbursement for ECMO in October 2018 (Jan 2019)
• The AST commented on "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses", voicing concern regarding potential restriction of access to lifesaving and life-sustaining therapies in transplant recipients. (Jan 2019)
• The AST joined over 100 other organizations on a coalition letter to HHS Secretary Azar, noting concern that funding is being drawn directly from money appropriated for public health and medical research to fund care for immigrant children forcibly separated from their parents and the border. The letter urges HHS to make public its plan to respond to and recover from this public health crisis, and avoid potential future transfers driven by the administration. (Oct 2018)
• The AST and IDSA drafted a joint letter to offer feedback on the draft Diagnostic Accuracy and Innovation Act (DAIA) and corresponding FDA technical assistance document. (Sept 2018)
• The AST signed on to a coalition letter to HHS Secretary Azar, requesting continued support of the Medicare Part D program's six protected classes and its value in bringing down costs to patients while not reducing access (April 2018).
• The Society signed on to a coalition letter requesting increased funding for the NIDDK in 2019 (March 2018).
• The AST's Transplant Administrators and Transplant Pharmacy Communities of Practices provided input on revised Interpretive Guidelines for the CMS Conditions of Participation for Transplant Centers (October 2017)
• The AST and AAKP sent a joint letter of concern regarding regional coverage changes for IVIg therapy for kidney recipients in June 2017.
• The AST comments on U.S. Senate Majority Party Leadership Release of Healthcare Reform Discussion-Draft in June 2017.
• AST signed on to a Friends of HRSA coalition letter, encouraging appropriate HHS funding in March 2017.
• The AST signed on to a coalition letter regarding impacts of hiring freeze on public health services in February 2017.
• The AST signed on to a coalition letter in January 2017 noting concerns regarding delays in reimbursement for home infusion therapies that were inadvertently created as part of the 21st Century Cures Act.
• The AST comments on recently passed American Health Care Act (AHCA).
• The AST comments on proposed modifications to CMS Transplant Outcome Measures and Documentation Requirements released on July 14, 2016
• The AST comments on revised CMS Interpretive Guidelines for the Organ Transplant Conditions of Participation for Transplant Centers released on April 11, 2016. Additional comments and suggested language changes were shared with CMS on May 26, 2016. 
• The AST response to the National Institute of Health (NIH) call for comment on proposed "Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV.

Archived Updates

Public Health Service (PHS) Guidelines

AST has provided the following comments on the PHS Guideline for Reducing the Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) through Organ Transplantation:

• Understanding OPTN/UNOS PHS Guideline: Effective Oct. 1, 2013, a new policy created to define PHS Guidelines, will allow members to use either the 1994 or 2013 version
• September 12, 2012 - Comments on most recent draft of the guideline
• June 15, 2012 - Letter to James Berger, Senior Advisor for Blood Policy, Re: Transplant Community Questions and PHS Revised Guidelines for Reducing HIV, HBV, and HCV through Organ Transplantation
• November 17, 2011 - Letter to the Honorable Thomas Frieden, MD, MHP, Director, Centers for Disease Control and Prevention, Re: Docket No. CDC-2011-0011
• August 23, 2011 - Letter to the Honorable Howard Koh, MD, MPH, Assistant Secretary for Health, Department of Health and Human Services from AST, ASTS, AOPO, and NATCO expressing concerns with the proposed PHS Guideline for Reducing HIV/HBV/HCV Transmission