Washington Round-up - For the week ending December 9

AST Leaders on Capitol Hill as Society Supported Legislation Remains Active & Advancing During Final Days of Lame Duck Congress

On Wednesday, December 7th, AST leadership flew in to Capitol Hill for face-to-face meetings with Congressional leaders active on AST supported legislation and public policy priorities in the clinical and research arenas. The purpose of the AST delegation traveling to Washington, DC was to provided additional advocacy and support for transplant related bills still advancing in the current 114th Congress and to lay the foundation for the Society's public policy agenda in the upcoming 115th Congress. 

I. Immuno Patient Coverage Companion Legislation Introduced in U.S. Senate During Lame Duck

Senator David Vitter (R-LA) recently introduced S. 3487 in the final days of the current "lame duck" session of Congress. The Senator Vitter legislation mirrors the exact legislation H.R. 6139 introduced earlier in the year in the U.S. House of Representatives by Congressmen Michael Burgess (R-TX) and Ron Kind (D-WI).  The Vitter bill was referred to the Senate Finance Committee.  Similar to the House immuno legislation, the introduction of the Senate bill is a clear indication that Congressional leaders remain interested in resolving gaps in transplant patient immuno coverages.

AST and the transplant community have all been very active for many years in supporting immuno medication policy changes and expansions in coverage. In addition to the Society's very robust annual public policy agenda, the AST remains committed to staying the course in improving patient immuno coverage so that every transplant recipient is covered for the life of the donor organ.

II.  AST Supported Transplant Patient Hospital Penalty Carve Out Language Approved as Provision in House Passed 21st Century CURES Act

Last week the U.S. House of Representatives included, voted on and approved the AST supported "Transplant Patient Hospital Penalty Carve Out" language as a provision in the House-passed 21st Century CURES Act. This provision would remove transplantation as a hospital readmissions penalty category under current law. The provision and the CURES Act will now be voted on this week in the U.S. Senate.

The AST has worked diligently over the last year in support of transplant patients and the carve out of "transplantation readmissions" as a penalty category under current law. 

III. 21st Century CURES Legislation Advances In Congress with Additional NIH Funding

The U.S. House of Representatives voted last week 392-26 to pass an updated version of the 21st Century Cures bill that would provide approximately $4.8 billion in medical research funding for NIH and bring about significant policy changes within the Food and Drug Administration  (FDA), including an additional $500 million in resources for implementation of the FDA provisions.  The new NIH funding will be in addition to the annual federal appropriations for the Institutes.

AST has worked proactively alongside the biomedical research community to support the NIH funding provisions included in the 21st Century CURES Act as well as within the FY 2017 Labor-HHS (NIH) funding legislation. 

IV. Incoming Trump Administration HHS Secretary - A Friend of AST on Capitol Hill

President-Elect Donald Trump has tapped veteran Congressman Tom Price (R-GA) to serve as the next Secretary of the Department of Health and Human Services (HHS). Price is a physician orthopedic surgeon currently serving in the U.S. House of Representatives as the Chairman of the Budget Committee.  AST has worked for many years with Congressman Price and his healthcare team on many health care policy issues. Along with fellow physician Congressman Michael Burgess (R-TX), Price was a leader of the Congressional Doctor's Caucus.

Dr. Price has been a vocal and leading critic of Obamacare and the Affordable Care Act (ACA).  Repealing and replacing the ACA will be one of the new Secretary's top priorities. Congressman Price is also expected to drive a variety of proposed changes for the Medicare and Medicaid programs.

V.  Living Donor Protection Act Continues to Add Cosponsors as Legislation is Likely to Be Re-Introduced in 115th Congress

The Living Donor Protection Act (LDPA) continues to receive additional support and Congressional cosponsors in the final days of the current "Lame Duck" session.  Although the bill remains a popular patient-focused policy proposal on Capitol Hill, the lead Congressional sponsors are now looking to possibly re-introduce a refined and more narrowly focused bill in the next 115th Congress. As currently drafted, the LDPA includes many positive policy changes for living donors. However, the broad nature of the legislation resulted in the bills being referred to a half a dozen Congressional Committees of jurisdiction....creating a lengthy and somewhat complicated path for passage.  AST has been in discussions with the bill sponsors, Congressmen Jerrold Nadler (D-NY), Dr. Michael Burgess (R-TX) and Senator Kristin Gillibrand (D-NY), regarding future development, re-introduction and consideration of the bills.

VI. Additional Positive AST Public Policy Developments

In addition to the public policy developments outlined above, the AST has also recently seen positive progress in the areas of FDA proposed oversight for Laboratory Developed Tests (LDTs) and the current law Medicare Part D Drug "Six Protected Classes".

Laboratory Developed Tests - Within the last month, the FDA indicated that the Agency was backing off of a proposal to implement additional oversight of LDTs. AST was concerned that such a proposal would have negative repercussions for transplant patient care. The Society has been active on this issue and testified before FDA to educate decision makers regarding transplant community concerns.

Medicare Part D Drug Six Protected Classes - The Centers for Medicare and Medicaid Services (CMS) also recently indicated that the Agency would likely not pursue removal (at this time) of transplant immunosuppressive medications as one of the Part D Six Protected Classes Category.  Removal of transplant immuno drugs as well as mental health medications has been a recurring recommendation of MedPAC (Medicare Congressional advisory  body) over the last few years. The AST has opposed and mobilized Members of Congress in the House and Senate to communicate strong opposition for this proposal to CMS and HHS. 

Dr. Chandraker and AST Government Relations Director, Bill Applegate, meet with Congressman Michael Burgess (R-TX)

Congressman Jerrold Nadler (D-NY) met with Drs. Rich Formica, Ron Gill, Emily Blumberg, Anil Chandraker and AST executive staff members Shandie Covington and Libby McDannell 

AST representatives with Congressman Ron Kind (D-WI) 

AST representatives spent a few moments visiting with Congressman Kevin Yoder (R-KS)

Congressman Earl Blumbenauer (D-OR) and AST representatives