Public policy

AST Washington Round-up, Week Ending October 28, 2016

AST Washington Round-up, Week Ending October 28, 2016

-2016 National Election Edition-

As you may be aware, the 114th Congress is currently in recess while members of the U.S. Senate and House of Representatives are back home running for re-election.  All 435 Members of the House, 1/3rd of the Senate and the White House will face voters on November 8th.  The foremost task facing Congress following the November 8th election will be to return to Capitol Hill (in a Lame Duck Session) and complete the 11 unfinished appropriation spending bills for the current fiscal year....including the HHS & NIH funding legislation for 2017.  The existing temporary federal funding measure that Congress passed before the election recess will expire on December 9th.

If Congress fails to complete action on the appropriations bills, the federal government could face a shutdown of all Agency functions deemed nonessential after Dec. 9th.  The "Lame Duck" Congressional Session is expected to last for approximately three weeks following the Nov 8th election (during the December timeframe).

AST and the solid organ transplant advocacy community have again worked diligently and successfully during this 114th Session of Congress.  These strong advocacy efforts have resulted in 3 of the Society's legislative priorities remaining very much active and "in-play" during the upcoming three week Lame Duck Congress in December.  In addition, all of the AST legislative priorities are scheduled to be re-introduced in 2017 by the Society’s Congressional champions (unless the measures achieve passage during the final days of the current Congress).  These still active priority bills that remain pending in the current Congress, include:

  • Newly introduced House bill H.R. 6139, “Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2016”, introduced on September 22, 2016;
  • House and Senate bills H.R. 4616 & S. 2584, “Living Donor Protection Act of 2016”;
  • House & Senate bills S. 3040 & H.R. 5926, “Labor, HHS Appropriations Act FY 2017 – NIH Annual Funding Legislation."

Your support is needed through an urgent grassroots call to action! Outreach to your members of Congress through the end of this year and again in 2017 after the new Congress is seated is requested to help build support by encouraging co-sponsorship of these important bills.

 

I. Transplant Immunosuppressive Drug Coverage Act Re-Introduced In the U.S. House of Representatives

Prior to Congress recessing and returning home to run for re-election, Congressmen Michael Burgess, M.D. (R-TX) and Ron Kind (D-WI) re-introduced the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2016.  The bill, H.R. 6139, was officially introduced at the end of last month on September 22, 2016.  Congressmen Burgess and Kind recognized the support of the AST in their formal statements of introduction on the floor of the House of Representatives and also included a statement of support from AST President Dr. Anil Chandraker in their joint Congressional press release.  For more information on the legislation and to view the Congressional press release and statement of introduction, check the AST Public Policy website or www.burgess.house.gov or www.kind.house.gov.  

Grassroots: AST has issued Action Alerts and initiated Grassroots campaigns on the Society’s public policy section of the website requesting that our membership reach out to their two Senators and one member of the U.S. House of Representatives in support of the Immuno Patient Coverage bill…requesting that their Members of Congress co-sponsor this important legislation.

Background: The bill would extend Medicare coverage of immunosuppressive drugs for kidney transplant recipients.  Medicare covers dialysis for most Americans, regardless of their age, with no time limit. However, if they are under age 65 or are not Medicare-disabled (receiving Social Security Disability Income), their eligibility ends 36 months after receiving a transplant.  The legislation eliminates the 36 month time limit to provide continued Medicare coverage for life-saving immunosuppressive medications. All other Medicare would end after three years for kidney recipients, as under current law.

 

II. Living Donor Protection Act of 2016 Continues to Attract Support as House & Senate Champions Strategize for Re-Introduction of the Legislation in 2017

The bipartisan and bicameral Living Donor Protection Act, S. 2584 & H.R. 4616, was introduced earlier this year during the AST CEOT meeting and has now attracted more than 40 co-sponsors in the U.S. Senate and House of Representatives. Key Senate supporters include: Mark Kirk (R-IL), Kirsten Gillibrand (D-NY), Chris Coons (D-DE), Susan Collins (R-ME), Chris Murphy (D-CT), and Chuck Schumer (D-NY).  The House of Representatives identical legislation continues to be led by Congressmen Jerrold Nadler (D-NY) and Dr. Michael Burgess (R-TX).  Co-sponsors continue to sign-on to and support the legislation.

Over the last seven months since the bill was originally introduced, the AST lobbyists have been hitting the halls of Congress in Washington, DC meeting with & educating more Members of Congress on the merits of S. 2584 & H.R. 4616.  These lobbying visits in the House and Senate, coupled with targeted grassroots letter writing, telephone calls, emails and other stakeholder efforts have resulted in over three dozen influential Members of Congress cosponsoring the bills. 

Regardless of timing, the national elections, and the winding down of the current Congress…all efforts are being executed in a strategic fashion with an eye toward securing support for the legislation now and into 2017 for the 115th Session of Congress should this election year prove limited in terms of end of year bill passage.  In other words, AST and the other supportive transplant stakeholder organizations have been instructed by our Congressional champions to aggressively secure support for the Immuno Bill, Living Donor Act, NIH Funding and all transplant related legislation as much as possible this year…so if necessary, we can roll that support over into the next Congress following the November election cycle and hit the ground running!!

House & Senate sponsors of the LDPA are discussing with AST and other stakeholders a strategy for re-introduction of the legislation that would involve fewer Congressional Committees of referral to expedite consideration of the legislation.  Upon introduction this past February, the LDPA was referred to 5 House and Senate Committees.  The AST and transplant stakeholder community have conveyed concerns to our Capitol Hill champions that we need to seek a more narrow and streamlined committee referral for the bills in 2017.

For more information on the legislation and to view the Congressional press release and statement of introduction, check http://nadler.house.gov/ or https://www.gillibrand.senate.gov/

Grassroots: AST has issued Action Alerts and initiated Grassroots campaigns on the Society’s public policy section of the website requesting that our membership reach out to their two Senators and one member of the U.S. House of Representatives in support of the LDPA…requesting that their Members of Congress co-sponsor this important legislation.

Background: This bill prohibits discrimination based on an individual's status as a living organ donor in the offering, issuance, cancellation, coverage, price, or any other condition of a life insurance policy, disability insurance policy, or long-term care insurance policy.

This bill amends the Family and Medical Leave Act of 1993 to specifically include living organ donation as a serious health condition that entitles a covered employee to leave under that Act.

The Department of Health and Human Services must update public service announcements, websites, and other media regarding live organ donation to educate the public on the benefits of live organ donation and access to insurance for living organ donors.

 

III. NIH-HHS Annual Funding Legislation - FY 2017 Labor, HHS & Education Appropriations Bill

The AST has continued to stay the course with consistent and aggressive advocacy tactics to educate lawmakers on the importance of NIH biomedical research dollars to the field of solid organ transplantation.  The Society has lobbied alongside and collectively with many of the national research coalitions and medical subspecialties to ensure that NIH funding remains “front of mind” to all Members of Congress and particularly those members serving on the U.S. Senate and House Appropriations Committees.

Earlier this year, both the Senate and House Appropriations Committees supported increases (up to $2 billion increase) for the National Institutes of Health (NIH).  The Senate Appropriations Committee approved $34 billion for fiscal 2017 and the House Committee approved $33.3 billion.  AST has been walking the halls of Congress daily requesting that Members of Congress support and provide NIH with at least the higher Senate Committee approved funding level of $34 billion in FY 2017.

Grassroots: AST has issued Action Alerts and initiated Grassroots campaigns on the Society’s public policy section of the website requesting that our membership reach out to their two Senators and one member of the U.S. House of Representatives in support of at least $34 billion in FY 2017 funding for NIH.

 

IV. Preserving Transplant Immunosuppressive Medications within the Medicare Part D Six Protected Classes - AST Continues to Deliver Message to MedPAC & Capitol Hill

White House Administration’s Top Health Officials Report No Action Likely to be taken at the Current Time – Transplant Immuno Meds Likely to Remain Protected Class for the Immediate Future

As you know, during the past year the Medicare Payment Advisory Committee (MedPAC) approved a recommendation to Congress urging the removal of two of the Medicare program’s protected classes...antidepressants and immunosuppressants. The official MedPAC report was delivered to Capitol Hill over the summer…and included a proposal to eliminate transplant medications as a protected class.

AST has been bullish and stayed the course in terms of educating and mobilizing Congressional and Agency support to preserve immunosuppressive medications as a current law protected class.  These advocacy activities have included coalition lobbying with other affected stakeholders, mobilizing AST Congressional relationships and grassroots efforts to combat the ongoing MedPac proposal eliminating transplant immuno medications from the protected class category.

One of the administration’s top health officials Monday expressed little confidence in changing how Medicare pays for certain classes of prescription drugs.

The Centers for Medicare and Medicaid Services is restricted by the existence of “protected classes” in Medicare, limiting the agency’s ability to engage makers of certain drugs in reforming how the agency pays them. CMS Deputy Administrator and Center for Medicare Director Sean Cavanaugh told a crowd at America’s Health Insurance Plans conference that engaging these companies is an “essential question.”

“On protected classes, Congress has been clear repeatedly that they don’t want the agency to change anything around protected classes, and I do realize, too, that that’s one of the areas we think of the tools that [prescription drug plans] PDPs have to leverage higher value,” he said. “I think for the foreseeable future that seems to be off the table because of congressional interest.”

Background: In 2014, more than 50 Members of Congress signed a letter to CMS strongly urging the Federal Agency to withdraw its proposal to remove certain categories of drugs from the Medicare Part D Six Protected classes. Additionally, House & Senate leaders also made clear their concerns to HHS and CMS during Congressional hearings convened in 2014.

Upon MedPAC's delivery of the report to Congress, the relevant Congressional committees for oversight of the Medicare program convened a hearing allowing the MedPAC Executive Director and commissioners to testify and discuss the report's recommendations.  AST and other stakeholder organizations reached out to those Members of Congress serving on the appropriate committees of jurisdiction – Senate Finance, House Ways & Means as well as House Energy & Commerce – requesting that those Capitol Hill offices express strong opposition to MedPAC’s recommendation for removal of two of the six protected classes during any upcoming Congressional hearings examining the report.

 

V. AST Continues To Weigh In On Legislation Introduced in U.S. Senate & House of Representatives That Could Have Negative Impact on Kidney Patient Access and Referral to Transplantation

As you know, Senator Heller (R-NV) introduced a companion bill a few months ago mirroring legislation previously introduced by Congressmen Young (R-IN) and Blumenauer (D-OR) seeking to establish a new Medicare payment reimbursement model directing kidney ESRD patients into capitated payment arrangements that could have a devastating impact on a kidney patient’s ability be referred and access organ transplantation.  The legislation, “Patient Access to Integrated-Care, Empowerment, Nephrologists, and Treatment Demonstration Act” are essentially payment model proposals that have been crafted into legislation and primarily developed and driven forward by a dialysis stakeholder company.

Although the bipartisan and bicameral legislation has been officially introduced into Congress (H.R. 5506 and S. 3090), the bills are not expected to reach the President’s desk this year or in this Congress.  The legislation was “marked-up” by the House Ways & Means Committee, but has not advanced in the Senate.

AST lobbyists in Washington, DC have been meeting with the sponsoring Congressional offices in the House and Senate to make them aware of the potential negative impact for kidney patients as it relates to transplantation.  Prior to the Congressional recess, former AST President Dr. Doug Norman, MD, an Oregon constituent of Congressman Blumenauer (D-OR), attended a local Oregon town hall meeting with Congressman Blumenauer to educate the lawmaker on the potential downside of his legislation for patients that could significantly benefit from kidney transplantation.  The Society delivered a letter to the sponsors of the PATIENT ACT outlining the provisions of concern within the legislation and urging the bill sponsors to work with the transplantation stakeholder community to address concerns regarding kidney patient referral and access to organ transplant.  AST lobbyists in Washington, DC have met with legislators and Capitol Hill staff directly and have also engaged in joint advocacy meetings with the stakeholder community and Capitol Hill to address the legislation.  The Society is also working closely with the Transplant Roundtable member organizations and Congressional Committee leaders to educate targeted lawmakers regarding the impact that the legislation may have for patients that could benefit from a kidney transplant.

 

VI. AST Remains Concerned for Rollout of New FDA Oversight Policy Overseeing Laboratory Developed Tests (LDTs)& Possible Negative Impact on Transplant Patients – Society Keeps Positive Report Language in the Approps Report

As you know, AST was both pleased and supportive of the recent FY17 Congressional Appropriations Report Language urging caution and further study prior to any new FDA policy changes regarding Laboratory Developed Tests (LDT).

See legislative appropriations report language below:

"Laboratory Developed Tests.—The FDA’s draft guidance issued on October 3, 2014, titled ‘‘Framework for Regulatory Oversight of Laboratory Developed Tests’’ (LDTs), puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated. Such a shift deserves input from the public, and Congress has been working with stakeholders, constituencies, and the FDA to find common ground on regulating LDTs. The FDA’s guidance circumvents the normal rulemaking process and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. The Committee directs the FDA to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner."

Although some Congressional leaders have urged caution and further examination with the yet to be officially released FDA policy for LDTs, other leaders from the House Energy & Commerce Committee and Senate Health, Education, Labor & Pensions (HELP) Committee indicated this past week that they may seek to advance their own LDT compromise oversight proposal this year.  Such a proposal may also have unintended negative consequences for transplant patient diagnostics. AST has learned that a Congressional hearing on LDTs may be convened by the House E & C Committee in the near future and that an LDT oversight amendment could still be advanced during the 114th Congress.

AST government relations staff in Washington, DC have continued to meet with House Appropriations Committee leaders and staff. The AST has been very involved on the FDA LDT issue at both the Agency and Congressional levels.....testifying before the federal agency in Washington, DC and educating House and Senate leaders.

On October 24th, CQ Roll Call publication provided the following update:

Within the last week, top laboratory and physician trade groups blasted the Food and Drug Administration for attempting to impose what they view as duplicative regulatory standards for advanced diagnostic tests. But the proposed approach to validating what are known as next generation sequencing-based tests was praised by major device manufacturers and biopharmaceutical companies.

Earlier this year, the FDA released a draft guidance document that outlined the agency’s suggested approach to evaluating whether next-generation sequencing tests perform as intended. Those NGS tests are much more advanced than regular diagnostics because they have the ability to sequence a person’s entire genome at once.  Next-generation sequencing is expected to play a large role in the switch toward more tailored medical treatments, known as precision medicine, which was in part one of the reasons FDA decided to issue its proposed framework.  “The future success of precision care and the promise of NGS can only be as good as the tests that guide diagnosis and treatment,” agency commissioner Robert Califf told reporters on a conference call in July.  But groups like the American Medical Association argue that NGS-based tests are laboratory developed tests, or tests used only within an individual laboratory, which are currently regulated by the Centers for Medicare and Medicaid Services. Physicians say imposing a new, duplicative regulatory process would negatively impact laboratories, physicians and, ultimately, patients.  The FDA has sought to separate the issues in the proposed regulation of laboratory developed tests from those in the guidance document released earlier this year on NGS-based tests. While the majority of comments addressed the next-generation sequencing guidance specifically, groups like the AMA say the two should be analyzed together.

The AMA said the majority of next-generation tests and services are lab-developed tests. The two guidances could leave physicians and laboratory medicine officials struggling to decipher which regulatory procedures their advanced tests should follow. “The AMA therefore urges the FDA to address this point of confusion by harmonizing the proposed requirements in both,” the group said.  Others, like ARUP Laboratories, a top clinical reference laboratory, explicitly stated that its comments on the NGS guidance document are not “intended to address whether LDTs are medical devices . . . or whether these draft guidance documents, if finalized, would be legally applicable to any LDTs.”  The American Clinical Laboratory Association also said the regulation of next-generation sequencing tests is not applicable to lab-developed tests.  “Our guidance documents do not constitute, and must not be construed as, an admission that LDTs are medical devices . . . or that these draft guidance documents, if finalized, would be legally applicable to any LDTs,” the group wrote.  An FDA spokeswoman previously told CQ Roll Call that the final guidance on lab tests could apply to next-generation sequencing tests.  “When the LDT guidance is finalized, it will outline the categories of LDTs that will remain under enforcement discretion and those that will be expected to comply with FDA requirements,” the spokeswoman said. “Any NGS tests that fall into the latter group will be expected to comply per the timeline outlined in the final guidance. One way to comply may be to follow the NGS guidance, when finalized.”

 

VII. Organ Donor Clarification Act – Legislation Introduced by Congressman Cartwright (D-PA) Focusing on Donor Incentives

Congressman Matt Cartwright (D-PA), a second term Democratic member of the U.S. House of Representatives serving on the Natural Resources Committee and Oversight & Government Reform Committee, introduced legislation in late May of this year, H.R. 5344, “Organ Donation Clarification Act of 2016”, seeking to (as stated in Rep. Cartwright’s legislative summary):

“Currently, organ transplantation is governed by the National Organ Transplant Act (NOTA) of 1984.  This law prohibits buying or selling organs for “valuable consideration.”

“Confusion about what constitutes valuable consideration has hampered donation by scaring people away from reimbursing living organ donors for things like medical expenses and lost wages,” said Rep. Cartwright.  “Both are legal under NOTA, but the law’s lack of clarity and its criminal penalties have created uncertainty and prevented reimbursements in many cases.”

The expansive kidney waiting list is also a burden on our nation’s finances, as the costs are becoming hugely expensive for Medicare and drains several other social service programs.  Increased transplants would save Medicare and the government billions of dollars.  Experts project that eliminating the waiting list would save taxpayers well in excess of $5.5 billion per year in medical costs and billions of dollars more in savings to other social programs.

The Organ Donor Clarification Act would:

  • Clarify that certain reimbursements are not valuable consideration but are reimbursements for expenses a donor incurs
  • Allow government-run pilot programs to test the effect of providing non cash incentives to promote organ donation.  These pilot programs would have to pass ethical board scrutiny, be approved by HHS, distribute organs through the current merit based system, and last no longer than five years”

The legislation has been endorsed by the following organizations: Americans for Tax Reform, American Foundation for Donation and Transplantation, American Medical Association, Fair Allocations in Research Foundation, Transplant Recipients International Organization, WaitList Zero.

Congressman Cartwright’s legislative summary states that NOTA's, “lack of clarity and its criminal penalties have created uncertainty and prevented reimbursements in many cases”….and that..."current law does not allow for any entity to test the effectiveness of providing non cash benefits to encourage donation.  These benefits could include funeral benefits for deceased donors and health insurance, tuition assistance, or other incentives to increase the number of living donors.” Congressman Cartwright convened a Congressional staff briefing during this past summer on Capitol Hill to garner greater interest and support for his legislation.  At this point, the bill does not have a companion proposal in the U.S. Senate.

The Cartwright Organ Donor Clarification Act remains under review by AST and many other national transplant stakeholder organizations.  AST leadership have reviewed and continue to discuss the draft bill.  AST government relations staff in Washington, DC have met with the office of Congressman Cartwright and provided transplantation public policy historical context and background on solid organ transplantation.  Early in the legislative development process, AST leadership drafted a letter to Congressman Cartwright applauding his interest in transplant & organ donation policy as well as to urge Cartwright's outreach efforts to include the full transplant stakeholder community.

At present, there is no specific request for action on this draft legislative policy proposal.  Stay tuned…….

To see a copy of the Organ Donor Clarification Act, click here.

 

VIII. Election Update 2016 – White House & Congress “In Play”

With just twelve days until Election Day, candidates are making a final push to rally their bases and get as many supporters to the polls as possible on November 8th.  The presidential race has been the center of media coverage as Sec. Hillary Clinton and Donald Trump battle for the White House. Most national polls show Clinton currently with a comfortable lead over Trump, but both candidates continue to campaign hard in the battle ground states and across the country. 

Also on the ballot November 8th are 34 Senate seats, all 435 House seats, and 12 gubernatorial positions.  The Senate races arguably have the most at stake since a strong showing by Democrats could make the Senate chamber flip from majority Republican to majority Democrat.  The Democrats would have to gain at least five seats to take back the majority. National polls currently show Dems flipping at least three seats, with 5-7 races being "too close to call."

The House Chamber is less likely to switch its Republican majority as the GOP currently has the largest margin of seats since 1928.  The Democratic Party would have to pick up no less than 30 seats to take back control of the House.  While it is likely they will close that margin considerably, taking back total control is unlikely. 

The Republicans have a strong hold at a state level, with 31 states being led by GOP Governors.  Of the 12 seats on the ballot this year, there are only five seats that polls show as toss-ups, three of which are already controlled by Democrats. 

Please click here to view more specific information on the Presidential, Senate, House, and Gubernatorial races from Bryan Cave.