What the elections mean for health policy

What the elections mean for health policy

By Jon Bigelow

A frenzied lame-duck session and a showdown over federal spending are in prospect as Washington prepares for the 118^th Congress. What will this mean for healthcare policy?

Due to press deadlines, I’m submitting this column just a few days after the midterm elections, with the outcome of 20 House races and control of the chamber still uncertain. But here’s an early look at a few themes to watch.

Gridlock — or cooperation?

It appears that Republicans will eke out a single-digit majority in the House; the question now is whether the next Speaker — presumably Kevin McCarthy (R-Calif.) — will have effective control of that majority. The struggle to hold essentially every member in line on every vote stymied prior Republican Speakers John Boehner and Paul Ryan, and firebrands in the Republican caucus have leverage to push a more extreme agenda and limit McCarthy’s room to negotiate with President Biden and Senate leadership.

Democrats kept control of the Senate — with either 50 or 51 votes, depending on the outcome of the Georgia run-off election on December 6. This allows Majority Leader Charles Schumer (D-N.Y.) to determine what issues come to a vote, gives Democrats the chair of each committee, and helps greatly in confirming nominees for administration or judicial positions. Winning 51 votes would reduce the ability of Sen. Joe Manchin (D-W.Va.) to block Biden administration policies.

Expect Republicans in the House to pass “message legislation” on favored issues, but Schumer will simply not bring those bills to a Senate vote. Since bills generally need 60 votes to pass in the Senate, legislation initiated there will have some bipartisan support and at least some chance of passing in the House. The result could be gridlock — or perhaps a chance for the parties to work together on at least a few issues.

House Republicans have promised hearings and investigations of many aspects of the Biden administration’s performance, and one focus will be to grill Dr. Anthony Fauci and other public health officials for their alleged mishandling of the COVID-19 pandemic. Also, note an important change on the Senate Health, Education, Labor, and Pensions (HELP) Committee: departing Sen. Richard Burr (R-N.C.), a relative moderate, will be succeeded as ranking member by Sen. Rand Paul (R-Ky.), who has long feuded with Dr. Fauci and other public health leaders.

First, the lame-duck session

Before the new Congress convenes in January, the outgoing Congress must address the federal budget for fiscal 2023 (which began on October 1). A Continuing Resolution (CR) kept the government running until December 16. Republicans will now want to pass another CR further delaying the deadline into January or February, when they will control the House and have greater leverage in forcing spending cuts.

Several non-budget measures that were dropped from the user fee reauthorization for the Food and Drug Administration (FDA) in September may have enough bipartisan support to be folded into the new CR. These include provisions to increase diversity in clinical trials, tighten rules for confirmatory trials on pharmaceuticals approved through the FDA’s accelerated approval pathway, enhance regulation of laboratory-developed diagnostic tests (the VALID Act), and require that the FDA be provided more information on ingredients of dietary supplements and cosmetics.

Further, the PASTEUR Act to incentivize development of new antimicrobials may now be rolled into either the CR or, reframed as a national security issue, into the must-pass National Defense Authorization Act.

The debt limit wild card

Hanging over the lame-duck session is the looming need to raise the federal debt limit. The Treasury Department projects it will reach the current borrowing limit during the summer of 2023. On the campaign trail a number of Republicans threatened to shut down the government to force Democrats to accept sharp reductions in spending. The Biden administration would prefer to address the debt limit in December while Democrats control both chambers.

Whether in December or in midyear, legislation to increase the debt limit will require a majority in the House and 60 votes in the Senate, so major compromises will be needed to avert a market-rattling default. A broad package of spending cuts and revenue enhancements may be required to break this impasse.

The process of stitching together this package poses significant dangers. Whatever the public posturing, the real negotiations will be done behind the scenes with little transparency. Where a key lawmaker with leverage objects to a specific spending or revenue provision, some other measure with an equivalent dollar value may suddenly be thrown in to make the totals add up. Democrats will fight efforts to repeal recent healthcare, climate, or infrastructure spending; Republicans will rebuff efforts to increase taxes. In this environment, the more politically palatable alternative of removing the deductibility of pharma marketing costs may once again be on the table.

Drug costs and other issues

This autumn, four Republican Senators introduced legislation to repeal the Inflation Reduction Act’s mandate for Medicare negotiations of prescription drug prices, but this was not a major campaign focus and polls suggest it would not be a winning issue with voters. Medicare price negotiations won’t begin until 2026, and it seems unlikely this issue will be revisited, at least until after the 2024 elections.

Conversely, it seems unlikely Democrats will try to expand the number of drugs included in the negotiating process. However, a bipartisan bill to cut out-of-pocket costs for insulin may pass.

Meanwhile, the Centers for Medicare and Medicaid Services (CMS) will be working this year to define the process for determining how to implement Medicare negotiation of drug prices. President Biden will also seek other regulatory measures to lower drug prices.

The prospects for the pandemic preparedness legislation championed by Burr and Sen. Patty Murray (D-Wash.), chair of the Senate HELP Committee, are shaky, especially in the midst of House hearings relitigating the COVID-19 pandemic response.

The Affordable Care Act (ACA) is unlikely to be an issue in the new Congress. The enhanced subsidies and lowered income thresholds that significantly expanded ACA coverage during the pandemic are set to continue through 2025, past the next election cycle.

Jon Bigelow is executive director, Coalition for Healthcare Communication.

cosmetics
pharmaceuticals
pharma
healthcare
public health
dietary
regulation
authorization
fda
clinical trials