Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


HHS to Cut ACA Advertising Budget

The U.S. Department of Health and Human Services (HHS) announced its decision to reduce the budget for promotion of the Affordable Care Act (ACA) last week. HHS will lower spending on Obamacare advertising and outreach from $100 million last year to $10 million going forward. The Administration also plans to cut payments for health insurance navigators, who assist people in choosing a health insurance option, by 39 percent. In order to increase accountability, funding for navigators will be proportional to how successful a navigator was in meeting their enrollment target the previous year. The decision has been strongly criticized by congressional Democrats, who believe that the move will make it more difficult for Americans to access coverage. HHS officials are planning on setting a goal for exchange enrollment for the coming year, but the target has not yet been announced.

FDA Announces New Stem Cell Policy

The Food and Drug Administration (FDA) will advance a new policy framework for stem cell therapies in the coming months. The FDA hopes to establish which regenerative medicine products are sufficiently complex to be considered within the agency’s regulatory authority, and to define a process for evaluating stem cell therapies for safety and effectiveness. The decision follows the FDA’s announcement that the company US Stem Cell Clinic marketed stem cell products without FDA approval. The Agency found that the firm’s deviations from current good manufacturing practice requirements may have affected the sterility of their products and put patients at risk. The FDA requests a response from the company within 15 days. The House Energy and Commerce Committee also announced that it plans to conduct a review of companies selling unproven stem cell treatments.

President Nominates ONDCP Director

The White House has announced President Trump’s intent to nominate Rep. Tom Marino (R-Pa.)as director of the Office of National Drug Control Policy (ONDCP). Rep. Marino previously served as U.S. attorney for the Middle District of Pennsylvania under President George W. Bush.

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