Government Funding Deadline Extended to Dec. 18; Ongoing Negotiations on COVID Package

In advance of the December 11 deadline, Congress passed a one-week stop-gap spending bill, extending the deadline for funding the federal government for fiscal year (FY) 2021 until December 18. Negotiators are still trying to reach a deal on a roughly $1.4 trillion omnibus package that would include all 12 appropriations bills. Lawmakers also continue to negotiate a bipartisan coronavirus relief bill, which may be attached to the appropriations package. An agreement was reportedly reached on Sunday evening to vote on employer liability protections and state and local government aid provisions as a separate bill. If the agreement holds, the larger of the two proposals would include $748 billion for enhanced unemployment insurance, small-business relief, and vaccine distribution funding, while the separate $160 billion measure would contain liability protections and state and local government aid. Complete details of each measure are expected to be released soon. Treasury Secretary Steven Mnuchin made his own $916 billion proposal on behalf of Republicans last week that was rejected by Democrats for failing to include additional money for supplemental unemployment benefits.

Sens. Josh Hawley (R-Mo.) and Bernie Sanders (I-Vt.) have warned that they will use the funding deadline to force a vote on a second round of stimulus checks for individuals. Their proposal would provide a $1,200 check to individuals making up to $75,000. House Majority Leader Steny Hoyer (D-Md.) has advised members that pending an agreement on the omnibus and further coronavirus relief legislation, votes in the House could occur as early as 6:30 p.m. on Tuesday. No votes are expected in the House until agreement has been reached on the omnibus or coronavirus legislation.

Senate Passes Several Health Bills

The Senate passed several health-related bills by unanimous consent last week. The Orange Book Transparency Act (H.R. 1503) is aimed at improving the database of generic drug approvals and patents and increasing pharmaceutical competition. The chamber also passed an amended version of the Safeguarding Therapeutics Act (H.R. 5663), which would give the FDA the authority to destroy counterfeit medical devices. Both measures were subsequently approved by the House of Representatives. The Senate also cleared the Purple Book Continuity Act (H.R. 1520) which relates to the published list of licensed biological products and the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act (S. 3451), which would add sesame to the list of major food allergens that are required to be identified on labels, starting in 2023, and would require a report and recommendations on federal food allergy regulations. The House passed a similar measure (H.R. 2117) earlier this year. Finally, the Senate amended and passed the Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies (TRANSPLANT) Act (H.R. 4764) which reauthorizes the C.W. Bill Young Cell Transplantation Program.

Clyburn Requests Details on Political Meddling at CDC

House Select Subcommittee on the Coronavirus Crisis chairman Jim Clyburn (D-S.C.) is requesting details into allegations that CDC Director Robert Redfield covered up attempted political meddling into the agency’s scientific work by Trump administration officials. His letter to Redfield and HHS Secretary Alex Azar requests documents and communications related to efforts to delete, conceal, or withhold an email from HHS senior advisor Paul Alexander demanding that the CDC insert new language in a previously published scientific report on coronavirus risks to children or “pull it down and stop all reports immediately.” Clyburn states that failure to produce the evidence in question could result in a subpoena.

Biden Outlines Pandemic Response Plans for First 100 Days

President-elect Joe Biden has pledged to administer 100 million coronavirus vaccinations and to reopen schools during his first 100 days in office. During a speech in which Biden introduced his administration’s first health care appointments and nominees, the President-elect also repeated his promises to mandate face coverings on airplanes, in federal buildings, and other places under the federal government’s control. The 100 million vaccine figure is in keeping with the vaccine supplies that have already been procured by the government, which will cover the vaccination of 50 million people since Pfizer and Moderna vaccines require two doses.

HHS Finalizes Rule on 340B Disputes

HHS published a final rule instructing the Secretary to assemble representatives from key agencies, including the Centers for Medicare and Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA), to resolve disputes in the program between hospitals or clinics and pharmaceutical manufacturers. The Affordable Care Act (ACA) called for the development of a process to address such disputes, but this is the first effort that has been taken to fulfil that requirement.

President Continues Push for $200 Drug Discount Cards

Work continues on a revised version of President Trump’s proposal to send Medicare beneficiaries $200 in drug discount cards. The plan would send a letter to 39 million beneficiaries within the next week, with the drug-discount cards being distributed later in December and in January. The plan was circulated inside the administration last week with instructions to expedite its approval. The Special Interest Group for Inventory Information Approval System Standards (SIGIS), which works with the Internal Revenue Service (IRS) to set the standards for health benefit cards, has raised concerns that the plan is not aligned with other regulated discount cards used for medical goods and services because the White House intends the cards to be used exclusively for drugs. The Trump administration, however, continues to urge SIGIS to reconsider its position and disregard the regulations in question.

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