Update on HOPA’s Health Policy Activities
Jordan Wildermuth, MSW
HOPA Health Policy and Advocacy Manager
Various attempts to repeal and replace the Affordable Care Act (ACA) delayed deliberation on all other healthcare legislation for most of the summer. Although the House managed to pass legislation to repeal the ACA in May, the Senate was unsuccessful in its efforts. Before leaving for summer recess, the Senate introduced a scaled-down repeal bill (dubbed the “skinny repeal”), which would roll back the ACA’s individual and employer mandates as well as the tax on medical devices. The measure did not receive enough votes to pass, leaving the future of the repeal–and-replace effort up in the air. Although conversation about next steps in the effort is continuing, Congress has pivoted from health care to the issues of tax reform and appropriations for fiscal year (FY) 2018.
FDA Reauthorization Act of 2017
On August 3, Congress passed the FDA [Food and Drug Administration] Reauthorization Act of 2017, reauthorizing the prescription drug, generic drug, medical device, and biosimilar user-fee programs through 2022. The Congressional Budget Office estimates that the new bill will generate $9 billion in fees—$8 billion for drugs and $1 billion for devices—between 2018 and 2022. The fees collected through the program are used to pay for the regulatory review of new medicines, with the intent of speeding up the approval process. HOPA has been monitoring the progress of the bill because it includes provisions pertaining to user fees for biosimilars. The final bill
- eliminates fees for supplements to biosimilar applications and biosimilar manufacturing facilities
- assesses holders of approved applications for biosimilars with an annual fee
- sets the annual amount of revenue that must be generated by fees
- extends through FY 2022 programs, policies (including Critical Path Public-Private Partnerships), and support for the development of medical products for rare conditions.
The Trickett Wendler Right to Try Act (H.R. 878/S. 204) sponsored by Senator Ron Johnson (R-Wis.), which allows people facing life-threatening diseases access to unapproved experimental drugs, was passed on the same day that the FDA Reauthorization Act was passed. The legislation prohibits the government from restricting access to medications that have undergone only preliminary testing in humans. Patients first would have to try all other available treatments and be unable to participate in clinical trials. The final version of the bill incorporates compromises made following a previous version, which faced scrutiny because it barred the FDA from considering any information on safety problems as part of its approval process for a drug falling under the right-to-try rubric. The latest version was modified to allow the agency to consider such information if it is critical to determining whether the drug meets the agency’s safety standards.
FY 2018 Appropriations
The House Appropriations Committee has passed a FY 2018 Labor, Health and Human Services, and Education (LHHS) spending measure, which contains funding for programs of interest to HOPA. Funding includes $35 billion for the National Institutes of Health (a $1.1 billion increase), $5.77 billion for the National Cancer Institute (an $82 million increase), and $300 million for the Cancer Moonshot Initiative. The Senate is expected to release its FY 2018 LHHS bill when it returns in September from the summer recess. HOPA continues to work with the entire cancer community to maintain and expand U.S. investments in research for cancer treatment to ensure that new innovations are possible.
Cancer Drug Coverage Act
In early July 2017, HOPA joined members of the Patients Equal Access Coalition and met with staff members in 18 Senate offices to solicit support for a Senate companion oral parity bill. The House bill was reintroduced in March and requires any health plan that provides coverage for cancer chemotherapy treatment to provide coverage for self-administered anticancer medication at a cost no less favorable than the cost of intravenous, port-administered, and injected anticancer medications.
HOPA has also initiated a state advocacy program working with the State Patients Equal Access Coalition. To date, 43 states have passed and implemented oral parity laws. HOPA is continuing its work to mobilize members in Michigan, North Carolina, and Tennessee to participate in these efforts and is working with HOPA members in New Jersey to support a bill that caps out-of-pocket spending on prescription drugs.
The number of House and Senate cosponsors of the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 314) continues to grow. HOPA’s visits with legislators on HOPA Hill Day in May garnered 11 additional cosponsors in the House and 1 in the Senate. The number of cosponsors has now crossed the two-thirds threshold among Republicans on the House Committee on Energy and Commerce that is required to bring a bill up for consideration. The Patient Access to Pharmacists’ Care Coalition implemented a summer media strategy consisting of digital and radio advertising.
HOPA will continue to monitor activity relating to repeal and replacement of the Affordable Care Act and to thoughtfully assess any legislation and coalitions that bear directly on HOPA’s mission and public policy agenda. HOPA has decided not to prioritize taking a position on repeal-and-replace legislation but instead to remain focused on securing provider status for pharmacists and seeing that patients have access to oral chemotherapy at a rate no less favorable than that for intravenous chemotherapy.