Forecast for Health Issues in the 115th Congress

The outcome of the 2016 elections presents an opportunity for Congress to break through the gridlock and advance legislative initiatives, especially in health care. It will take Congress and the incoming Administration time to regroup and figure out their priorities, agendas and paths forward. Indeed, this opportunity allows all the option to take a fresh look at legislative prospects, reassess strategies, and broaden approaches to think outside the box.

The election results will impact the length and content of the Lame Duck session, scheduled to begin the week of November 14. Republicans are likely to address must pass legislation, such as passing a continuing resolution (CR) to ensure federal funding into 2017 knowing they can return to address the longer-term issues next year when a Republican administration is in place.

Budget/Appropriations – The 114th Congress must address the current spending deadline for fiscal year 2017 by December 9, 2016 when the current funding expires. Should a continuing resolution (CR) passed by the 114th Congress end prior to September 30, 2017 (the end of the current fiscal year), the 115th
Congress will need to revisit FY’17 funding. Regardless, the 115th Congress will need to consider the 12 spending bills for fiscal year 2018 by October 1, 2017. President Trump’s budget blueprint will be due to Congress early in 2017. Congress would then pursue the budgetary process, which could include consideration of a budget resolution. If Congress chooses to pursue budget reconciliation legislation, it could, due to special rules, serve as a vehicle to repeal parts of the Affordable Care Act (ACA). The Senate process normally requires 60 votes to proceed to consider legislation and stop a filibuster. However, the budget reconciliation process only requires 51 votes allowing a majority party to pass initiatives that impact the federal budget. Republicans used this process in the 114th Congress to pass legislation to repeal the individual insurance mandate penalty, Medicaid expansion, and certain subsidies for purchasing insurance through exchanges. Those initiatives were vetoed by President Obama.

21st Century Cures/Senate Innovations – If Congress is unable to successfully pass a revised 21st Century Cures bill during the Lame Duck session of the 114th Congress (beginning November 14, 2016), then many of the bipartisan provisions in that package are expected to be considered as part of the upcoming FDA reauthorization (discussed below). More recently, the issue of rising prescription drug costs has been linked to this effort with several groups and Members of Congress urging that the bill not be passed unless it address drug prices. The day after the election, Senate Majority Leader Mitch McConnell (R-KY) reiterated that passing 21st Century Cures in the Lame Duck session is a priority.

Affordable Care Act (ACA) – President-elect Trump has stated his desire to repeal and replace Obamacare, citing higher premiums, less competition and fewer choices. As a candidate, Donald Trump called for Congress to repeal Obamacare, eliminate the individual mandate, allow the sale of health insurance across state lines, allow individuals to fully deduct health insurance premium payment, allow individuals to use Health Savings Accounts (HSAs), require price transparency from all healthcare providers, block-grant Medicaid to the states, and remove barriers to entry into free markets for drug providers that offer safe, reliable and cheaper products. Aside from congressional activity, a Trump Administration would have discretion to impact the law through the regulatory process and Executive orders.

Independent Payment Advisory Board (IPAB) – IPAB was created in the ACA, but a republican congress has blocked funding for IPAB and no individuals have been appointed to serve on the Board. The IPAB has been criticized for having 15 expert members who would have broad authority to recommend changes to Medicare payment policy and little accountability. The ACA provides a process to deactivate the Board, requiring legislation be introduced by February 1, 2017. The House of Representatives voted in 2015 to repeal the IPAB in its entirety. IPAB is expected to receive attention in 2017 due to the timeline to introduce repeal legislation as well as the expectation that Medicare spending will trigger the Board which is required to recommend changes to Medicare spending when it exceeds a target rate.

Center for Medicare and Medicaid Innovation (CMMI) – Another ACA creation, CMMI is tasked with identifying and testing Medicare and Medicaid payment and service delivery models. The ACA provides CMMI with very broad authority, including the ability to waive statutory or regulatory limitations as needed to carry out demonstration projects. CMMI has recently come under political fire for proposing a controversial and sweeping demonstration project involving Medicare payment for Part B drugs. This led Republicans to argue that some limitations on the agency’s authority were necessary. It will remain to be seen whether the election’s shift in the balance of power reduces Republicans’ appetite to put limitations on CMMI, now that the agency will be under the control of a Republican Administration.

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) – MACRA was crafted in a bipartisan manner, through regular committee order, and passed with overwhelming support (392-37 in the House; 92-8 in the Senate). This effort is not expected to be repealed; however, there may be tweaks to improve the implementation of the law which transitions Medicare fee-for-service payment to value-driven and outcomes-based arrangements. A component of MACRA, rooted in the ACA, is the “meaningful use” of certified electronic health records (EHRs), which continues to increase. While there has been a bipartisan push to achieve interoperability of these health information technology (IT) systems, Republicans have been the most vocal about concerns with the current state of their usability and connectivity. With this new Congress and Administration, efforts to address these long-standing concerns, such as the development and adoption of standards to enable bidirectional exchange of health information across disparate health IT systems, including clinical data registries (CDRs), could move forward at a more rapid pace. The 21st Century Cures package, as passed by the House in 2015, includes interoperability provisions.

Children’s Health Insurance Program (CHIP) CHIP funding was addressed as part of MACRA and current funding expires September 30, 2017. Republicans in the House of Representatives names a work group to review CHIP-related policies and the tension in addressing this ‘must-pass’ legislation will be related to whether it is a clean bill with no policy changes and only extends the funding or whether it will address policies within the program. If it’s a clean funding bill, it could extend funding for two years since the program’s full legislative authority expires in 2019. There are many calling for Congress to address CHIP funding earlier in 2017 recognizing that many state legislatures adjourn earlier than September 30th and will need time to set their budgets accordingly. Previous authorization efforts including debate on the funding levels and possible repeal of the provisions related to state eligibility requirements.

FDA User Fee Act reauthorization (UFAs) – The Prescription Drug User Fee Act (PDUFA) VI, which provides the Food and Drug Administration (FDA) with the authority to impose user fees to fund agency activities, must be reauthorized by September 30, 2017. Since user fees account for about half of the FDA’s total budget, Congress will work to finalize this legislation by summer 2017 to meet the deadline in plenty of time, especially knowing that Congress is usually not in session most of August. This legislation is expected to include reauthorization of the user fees for medical devices, biosimilars, generic drugs, and others. This ‘must-pass’ legislation will likely serve as a vehicle for other related initiatives, including provisions in the 21st Century Cures legislation if it is not addressed in the Lame Duck session of the 114th Congress, as well as efforts to address drug pricing or other FDA-related initiatives.

December 31, 1969: | Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11



 -  2019

 +  2018