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 legilatures. 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.
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 and AST President review each proposed policy released for comment to assess which Communities of Practice or Committees should review the proposals and suggest comments.
2. The leadership of the appropriate Communities of Practice or Committees develop suggested comments that they forward to the AST OPTN/UNOS Policy Work Group.
3. The AST OPTN/UNOS Policy Committee then reviews all of the comments and generates a single comment for each policy that clearly states the position of the Society as being in favor, as having specific concerns, or opposing the proposed policy.
4. The AST Board of Directors then meets with the AST OPTN/UNOS Board Liaison to approve or amend the comments that are submitted to the OPTN on the proposed policies.
AST comments on OPTN/UNOS Policy Proposals:
- October 11, 2016: Comments on 15 proposals
- March 23, 2016: Comments on 9 proposals and one concept paper
- October 14, 2015: Comments on 12 proposals
- March 27, 2015: Comments on 10 proposals
- December 5, 2014: Comments on 17 proposals
- June 13, 2014: Comments on 17 proposals
- December 6, 2013: Comments on 6 proposals
- September 9, 2013: Comments on OPTN Plain Language Policy Rewrite
- December 2014: Directors' Report - Biannual Update
- AST applauds the efforts of UNOS to explore ways of increaing equity in access to transplantation by examining the issue of liver redistricting. In response to these efforts, the AST created an educational document on liver redistricting.
- 2014 Biannual Update on UNOS Activities
- OPTN/UNOS Concept Document on Alternatives for Liver Allocation
- UNOS Names Stepham Harms as new Chief Operating Officer
- OPTN/UNOS video podcast on, "The new Kidney Allocation System: What Referring Physicians need to know"
AST Support for Pending Legislation
- A letter noting concern related to the ESRD Integrated Care Act's negative impacty 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
- Support and recommendations for 21st Century Cures
- H.R. 6, 21st Century CURES & Section 3041 Provision Protecting Physician Educational Materials
- Next Generation Researchers Act - introduced by Senator Tammy Baldwin (D-WI). This legislation seeks to support our nation’s next generation of young researchers and reverse the decline in NIH research funding.
- Living Organ Donor Protection Act of 2014 - introduced by Congressmen Jerrold Nadler (D-NY) and Michael Burgess, MD (R-TX). The legislation seeks to promote and protect living organ donors from discrimination
- House Energy and Commerce Chairman's 21st Century Cures Initiative - aims to accelerate medical research to develop new cures and treatments for patients.
- Capitol Hill Legislation Establishing Beneficiary Equity in the Hospital Readmission Program - the AST has been working closely with Congressman Jim Renacci's (R-OH) office to garner support for this legislation that seeks to exempt organ transplantation, ESRD, and other targeted conditions from classification as an admission for purposes and penalties under the Affordable Care Act (ACA).
- Immuno Drugs remain protected.
- AST supports docket No. FDA-2013-D-1358 - Draft guidance for industry: recommendations for premarket notification (510(k)) submissions for nucleic acid-based human leukocyte antigen (HLA) test kits used for transfusion and transplantation.
- AST urged for strongest possible FY 2014 302(b) allocation for the Labor, Health and Human Services, Education and Related Agencies (Labor-HHS) Appropriations Subcommittee within the discretionary cap established by the recently Bipartisan Budget Act of 2013.
- Proposed Rule OAR 836-053-0008, request for comments on provisions in health reform proposed rule regarding 24-month transplant waiting period.
- AST President, Dr. Daniel Salomon, attended White House Oval Office Signing of HOPE Act.
- Congress passed HIV Organ Policy Equity Act (HOPE Act) - legislation that will lead to increases in life-saving donor organs and vital research in the area of HIV organ donatin and transplantation
Other Regulatory Updates
- 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."
- The AST supports the founding of the recent bipartisan Senate NIH Caucus in a letter to Senators Richard Durbin (D-IL) and Lindsey Graham (R-SC).
- The Transplant Roundtable, made up of a group of organizations including the AST, submitted testimony on April 3, 2015 to support increased funding for the Division of Transplantation (DoT). Given the need for donor organs and the important programs administered by the DoT, the Transplant Roundtable requested an additional 3 million in funding: read the testimony for more details.
- Dr. Richard Formica presented a statement on behalf of the AST Board of Directors at the March 13, 2015 ACOT meeting; Rebecca Hays presented a statement on behalf of both the AST Board of Directors and the Live Donor Community of Practice (COP) at the same meeting
- View information on key messages about the ebola outbreak
- Interview forms optimized for obtaining medical history, behavioral risk, and travel information for a donor of organs and/or tissues are now available.
- AST recognized Congresswoman Lois Capps with the AST Transplant Advocacy Award for her years of crafting legislation that ultimately culminated in the HOPE Act.
- The Donation and Transplantation Community of Practice approved to increase the number of transplants each year by 1,000 over the next 5 years.
- NIH opens research hospital to outside scientists - new projects will enable non-government researchers to conduct clinical research.
- The Transplant Roundtable provided comments to the Centers for Medicare and Medicaid Services on Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs.
- AST raised concerns regarding proposed rule to remove immuno medications as a protected class under Medicare C and D.
- AST raises concerns about plans to limit Medicare drug coverage.
- New clinical research network holds great promist for improving treatments for patients.
- September 24 & 25, 2013 - AST's Public Policy Committee descended on Capitol Hill to meet with more than a dozen Members of Congress to garner further support for federal NIH funding and medical research, and to strengthen support and cosponsors for the Transplant Patient Immunosuppressive Drug Coverage for Kidney Patients Act of 2013
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