Congress

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

A bipartisan group of 32 senators is asking CMS to extend its proposal to apply higher pay rates for durable medical equipment suppliers in rural areas, and Alaska and Hawaii, to also include suppliers in all non-bid areas, and more than 130 House lawmakers also sent a letter to the agency Oct. 12 with a similar request.

Industry lawyers say it is not clear whether Congress' expansion of the sunshine law's reporting requirements to include industry payments to health professionals beyond doctors will kick in in 2021 or 2022.

The cost and frequency of surprise out-of-network medical bills have risen dramatically in the individual market over the past few years, causing federal lawmakers from both parties to propose legislation that would prevent insurers from overcharging individuals for treatment by out-of-network providers in emergency care situations.

The Senate is expected to vote this week on Sen. Tammy Baldwin's (D-WI) resolution to overturn the Trump administration's rule expanding short-term health plans, forcing senators on both sides of the aisle to go on record about their support of the controversial plans which do not include mandatory coverage for preexisting conditions.

Sens. Susan Collins (R-ME) and Joe Manchin (D-WV) both suggested on Friday that Supreme Court nominee Brett Kavanaugh's view on the severability doctrine allayed their fears that he would move to undermine the Affordable Care Act's protections for those with preexisting conditions.

Brand-drug makers' lobbying maneuvers in their failed bid to get Part D donut hole changes included in the opioid legislation could factor into an expected new push by the industry for the changes during the upcoming lame-duck session of Congress.

House Rules Chair Pete Sessions (R-TX) and dozens of other GOP lawmakers on Tuesday proposed a resolution stating that any Affordable Care Act replacement must give states more flexibility to run their own markets and must encourage policies that keep plans affordable for people with preexisting conditions, yet the resolution does not directly state that GOP health plans would require guaranteed issue or community-rating in all circumstances.

The sweeping opioid deal passed by the House Friday (Sept. 28) includes new language aimed at closing a loophole in separate gag-order legislation that requires makers of biologics to report to the Federal Trade Commission settlements that could delay biosimilar competition.