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.


Energy and Commerce Considers Off-Label Communication Ahead of FDARA Markup

Members and sta of the House Energy and Commerce Committee are debating a proposal to expand the ability of drug and device manufacturers to engage in off-label communication as a part Food and Drug Administration Reauthorization Act (FDARA) negotiations. The Medical Product Communications Act (H.R.1703), sponsored by Rep. Morgan Gri th (R-Va.), would allow communication about unapproved uses of products if the information is supported by scientifically appropriate and statistically sound data, and includes a statement noting that the FDA has not approved the drug or device for the discussed use. Democrats are opposed to the bill’s inclusion in legislation to reauthorize the FDA’s user fee programs, asserting that they already compromised on the issue of off-label communications in the 21st Century Cures Act. The Energy and Commerce Committee had originally signaled that it would hold a full-Committee markup of FDARA before adjourning for Memorial Day recess, but delayed scheduling the markup because of this disagreement. The Senate’s user fee package, which has already been advanced out of committee, does not address off-label communications.

Lawmakers Urge More Flexibility for Third-Party Payment Policy

Reps. Kevin Cramer (R-N.D.) and Doris Matsui (D-Calif.) have written to Secretary of the U.S. Department of Health and Human Services (HHS) Tom Price outlining their concerns with policies regulating charitable assistance for health insurance premiums. Restrictions currently exist on third-party payments intended to subsidize premiums for patients in qualified health plans, which the lawmakers believe have the negative effect of steering patients toward government programs. “We urge HHS to...issue a new rule that adds the following to the existing list of entities from which premium and cost sharing assistance is required to be accepted: (1) nonprofit charitable organizations; (2) places of worship; and (3) local civic organizations,” the letter states. An additional 182 members of the House of Representatives signed on to the letter.

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