As the 117th Congress moves into its second legislative session, there is no shortage of health care policy issues dotting the landscape. The COVID-19 pandemic, legislative gridlock and a 2021 that was largely locked down by ongoing negotiations around the infrastructure and Build Back Better packages have left a range of stakeholders looking and hoping for actions on priorities that have been stalled in this climate. Congress has now mostly confirmed President Biden’s administration leaders across the Department of Health and Human Services and other health-related agencies, with the notable exception of Dr. Robert Califf, who is expected to be confirmed as Food and Drug Administration (FDA) Commissioner early this year and whose nomination will be voted on by the Senate HELP Committee on Wednesday, January 12.
Conventional wisdom would hold that as the months pass, attention will increasingly be diverted to the midterm elections. This means stakeholders have relatively little time ahead of the election to achieve enactment of legislative priorities or to position them for possible action and resolution during the lame duck legislative session in late 2022. Lame duck sessions are always unpredictable and can range from sessions of limited activity to those in which major legislation is enacted — and could be even more unpredictable this year if the mid-term result in changes to the majorities in one or both chambers of Congress.
The ongoing uncertainty of the COVID-19 pandemic will affect legislating this year, particularly if a worsening pandemic leads to calls for additional federal interventions. Congress continues to conduct oversight over the agencies’ handling of the pandemic and may feel the need to intervene either on policymaking or funding, which is important but may distract from other efforts. Politicization of policies at the federal, state and local levels around things like masking and vaccination requirements will contribute to increased partisanship on Capitol Hill, which can slow legislating. And a still limited ability of stakeholders to meet with Congressional offices in person has some impact on the ability to get lawmakers’ attention, although virtual meetings can also be effective.
Another factor is that the number of “must-pass” pieces of legislation in the health space is fairly modest compared to some past years. For example, in late 2020, Congress extended several expiring health programs through 2023. The relatively modest number of must-pass bills could make it more challenging for other pieces of legislation to move forward. However, there are some bills out there. This piece will look at some of these must-pass bills as well as other items on the health care landscape.
Congress’ inability as of yet to finalize its fiscal year (FY) 2022 spending bills means the federal government is currently operating on a continuing resolution through February 18. If Congress does not finalize the bills by that date, which could be a stretch, it would need to pass another temporary extension that would continue funding the government at FY 2021 levels. Many stakeholders are hoping that does not occur, particularly those in the health care space that stand to benefit from increases contained in bills developed last year by the House or Senate.
If Congress is unable to fully resolve FY 2022 by February or March, the prospect of passing a year-long continuing resolution that funds operations at FY 2021 levels becomes increasingly likely, particularly as lawmakers will have to focus on preparing bills for FY 2023, which starts on October 1, 2022.
For those stakeholders looking to influence FY 2023 spending, the lion’s share of the work typically occurs in the spring months. Committees may release and mark up individual bills before August, and some could even come to the floor of the House, but Congress most likely will not finalize that legislation until late 2022 after the mid-term elections. It is worth recalling 2018 when Congress, in a rare example of finishing appropriations bills ahead of schedule, did enact the FY 2019 Labor, Health and Human Services and Defense package in September while other departments and agencies were impacted by a lengthy government shutdown.
Outside of appropriations, Congress must act by the end of September to authorize the user fees that are responsible for funding a significant amount of the Food and Drug Administration’s review operations. User fees date back to 1992, starting with the Prescription Drug User Fee Act (PDUFA), and have been reauthorized every five years since. Before September 30, Congress must now pass legislation to reauthorize user fee agreements for prescription drugs, generic drugs, medical devices, biosimilars and animal drugs. In past years, Congress has dispensed with user fees well ahead of the deadline, with the 2017 package being enacted in August and the 2012 package in July of that year. The potential disruptions to FDA review operations if the authorization of the fees is delayed should help keep this bill moving under the typical timeline. The agreements themselves are negotiated ahead of time between the industry and the agency, so there is built-in public and private support to ensure that FDA can continue to review and approve drugs and devices.
In addition to authorizing FDA to accept fees from medical product companies, the legislation is often used to advance other FDA-related policy changes. As Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) of the House Energy and Commerce Committee continue to push for a follow-on to their very popular 2016 21st Century Cures Act law, there is a chance Cures 2.0 — or at least components of it — could be combined with a user fee package.
There are additional priorities on the agenda that could gain traction in 2022 that stakeholders should keep in their view. These include the following:
2022 promises to remain another eventful and fluid year with much of it dominated by the lead-up to the November midterm elections. Healthcare stakeholders will have to pay close attention to a fluid and ever-shifting landscape to advance priorities as vehicles remain limited and windows narrow. This will include ongoing efforts to revive Build Back Better or pieces of the package, including those pertaining to health care issues.
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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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