Biocom - Life Sciences Association of California
San Diego  |   Los Angeles  |   Washington, DC  |   Tokyo

Public Policy Newsletter

usa flag

Federal Affairs

ACA Repeal and Replace Draft Released 
On February 24, a legislative draft of the House GOP plan to repeal and replace the Affordable Care Act (ACA) leaked out, filling in the details of a formal policy brief released a week earlier by House Republicans and detailing their vision for replacing the healthcare law, which has been the law of the land since its passage by Congress in 2010. The proposals build upon the Better Way white paper made public last year by House Republicans. 

The legislation would:
- Repeal the individual and employer mandate penalties. As a replacement, the bill would impose a penalty of 30 percent of the monthly premium rate for individuals who do not maintain continuous coverage for at least 63 days;
- Repeal most of the ACA’s taxes, including the medical device tax, and cap the tax exclusion for employer-sponsored health insurance at 90 percent of premiums;
- Repeal essential health benefits, leaving decisions about which healthcare services insurance plans are required to cover to the states, starting in 2020;
- Repeal the Prevention and Public Health Fund;
- Provide refundable health care tax credits to Americans who do not receive insurance through their employer. The credit is based on age, not income, from $2,000 for young adults up to $4,000 for those over 60 years old. It is not available to be used for plans that cover abortion; 
- Eliminate the Medicaid expansion and replace it with block grants to states; 
- Expand the use of Health Savings Accounts (HSA); and 
- Establish State Innovation Grants. States can use the pool to reduce out-of-pocket costs, promote access to preventive services, and stabilize small group markets. 

However, the final bill could still be very different, as House Republicans work to gather support from colleagues in both the House and the Senate and await a price tag from the Congressional Budget Office (CBO). Legislation is expected to start coming out of the Energy & Commerce Committee and the Ways & Means Committee, which share jurisdiction over health care matters in the House, as early as next week. The Senate and Trump Administration have not released similar proposals. 

During his first address to Congress on February 28, President Trump showed support for the plan, mentioning HSA accounts, tax credits, protecting patients with pre-existing conditions, and a transition period away from the exchanges. He also reiterated his campaign promises to permit the purchase of health insurance across state lines, bring down the cost of prescription drugs, and “slash the restraints” at the Food and Drug Administration (FDA) to speed up drug approvals. 

Join Us for our 2017 Oncology DC Fly-In 
Building on the successes of our Digital Health Fly-In and Precision Medicine Fly-In these past years, Biocom will host another themed fly-in in 2017, focusing on oncology. 

The event will be held from April 5th to 7th and provide a small group of executives with the unique opportunity to meet with Washington DC regulators and legislators in an intimate setting to directly educate them about oncology and discuss new developments and policy initiatives, as well as issues of concern. The event now coincides with the American Association for Cancer Research (AACR) Annual Meeting (April 1-5) but remains independent.

This event is for Biocom members operating in the oncology space. There is no registration fee. Click here for more information. To confirm or discuss your participation, please contact Biocom’s Director of Federal Policy and Government Affairs, Laure Fabrega.Space is limited.

HHS, CMS, FDA, NIH Leadership Update
Cabinet confirmation votes are still underway in the Senate, with 16 cabinet members confirmed so far. Former Georgia Congressman Tom Price was confirmed at the head of the Health and Human Services Department (HHS) on February 10 with a party-line vote of 52-47. The 62-year-old orthopedic surgeon will run a $1 trillion department, which oversees many agencies important to the life science industry, including the Food & Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the National Institutes of Health (NIH).

Seema Verma, the administration’s nominee to lead CMS who helped craft Indiana’s expanded Medicaid program, is currently being considered in the Senate. The Senate Finance Committee held a confirmation hearing on February 16, where she advocated for limiting the role of the federal government in administrating healthcare services, with more flexibility to the states. CMS has been responsible for implementing the Affordable Care Act (ACA) and the Medicaid expansion, which the Administration and Republicans have vowed to repeal and replace. On March 1, the committee voted 9 to 9 on whether to send Verma’s nomination to the full Senate for confirmation, which led to a second vote on March 2. Verma’s nomination was then favorably reported by a 13-12 vote and we expect the full Senate to take it up shortly.

President Trump’s pick to head the FDA is still to be named. Biocom has made it clear that whoever is nominated should understand the approval process on a very detailed level and, preferably, have experience with a regulated entity, from the research, commercial side, or agency side. In addition, experience as a patient advocate or with patient groups would be extremely valuable, as Biocom supports including more patient input into segments of the FDA review and approval process. Patient-focused drug development provisions have been included in the 21st Century Cures Act, which was signed into law at the end of last year, and in the user fee agreements negotiated between FDA and industry and to be reviewed by Congress this year. 

NIH Director Francis Collins has been asked to remain at the head of the agency, at least temporarily, and will not need a confirmation hearing.

Upcoming Public Policy Events
Oncology Advocacy Fly-In
April 5, 2017
4:00 PM