Congress

As part of the year-end package, lawmakers plan to mitigate effects of changes to the 2021 physician fee schedule that would raise pay for some while drastically cutting pay for others, according to a House Ways & Means Republican summary, and the bill also is expected to extend the Medicare sequester moratorium for three months -- a shorter extension than sought by providers.

Congress’ year-end coronavirus relief and spending deal appears to include FDA-related provisions that would extend the agency’s rare disease priority review voucher program until 2024, allow biosimilars applicants to reference previously approved indications in their applications, give FDA authority to require that generic drug labels be updated, and clarify that orphan drugs and biologics must prove clinical superiority.

The House on Friday evening (Dec. 18) passed a two-day stopgap continuing resolution that gives lawmakers the weekend to hammer out the details of a year-end package that wraps together spending and pandemic relief measures, and possibly also surprise billing legislation, health extenders and other key health policies.

Generic drug lobbyists are scrambling after learning that health extenders might be paid for with legislation that would stop generic drug makers from blocking competitors by parking 180-day exclusivity periods.

A bipartisan group of 27 senators, led by Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH), sent a letter to Senate leaders Monday (Dec. 14) urging them to include the compromise surprise billing legislation in the year-end spending bill.

Liability protections have become enough of a sticking point for the bipartisan coalition of senators who proposed a $908 billion COVID-19 relief package that they’ve broken it into two bills -- tying in a separate, narrow bill the $160 billion for state, local and tribal governments to whether lawmakers can agree on liability protections.

Incoming House Appropriations Committee Chair Rosa DeLauro (D-CT) could play a key role in FDA-related spending decisions due to her close dealings with Rep. Sanford Bishop (D-GA), who heads the FDA appropriations subcommittee that DeLauro has previously chaired, the Alliance for a Stronger FDA suggests.

The House on Wednesday (Dec. 9) passed a one-week government funding extension as lawmakers continue to negotiate a potential COVID-19 relief package and stakeholders push to get their priorities, like a fix for pay cuts to certain physicians and a continued moratorium on the Medicare sequester, into an end-of-the-year bill.

Senate Majority Leader Mitch McConnell (R-KY) on Monday (Dec. 7) said the Senate will likely pass a bill to push back the expiration of government funding through next week and urged Democrats to support his COVID-19 relief legislation -- but his speech on the floor did not mention the $908 billion bipartisan COVID-19 relief package that House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Chuck Schumer (D-NY) previously said should serve as a starting point for negotiations.