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
AST Support for Pending Legislation
- 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 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
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.
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