Taking the Pulse on 2022 Healthcare Policy Opportunities
This time of year – the sprint between Easter and Memorial Day in the second year of a Congress – has those on and off Capitol Hill looking at a very long to do list and a very short timeframe to accomplish it. Even still, there is the sense that everything in Congress has begun slowing down ahead of the November election.
The window of opportunity can be extended beyond Memorial Day: there's always a good chance Congress will come back after the November election to handle the National Defense Authorization Act, and a continuing resolution will likely be used to move us into next year. But the question we and the rest of Washington have been asking is simple: what has to get done legislatively by January 3?
In the healthcare space, COVID is getting the most attention. It's one of a handful of issues we anticipate some sort of movement on in Congress over the coming months:
COVID Relief: After dropping out of the omnibus over payfor disagreements, a bipartisan agreement on COVID relief ended up at less than half of what the Administration had requested. Securing relief is a priority for leadership on both sides, but there still seems to be disagreement on details. But by and large, the Republican caucus is not supportive of further aid and has tied up the proposal with immigration, effectively stopping the package in its tracks.
FDA User Fee Reauthorization: If COVID relief is something that could get done, the FDA user fee reauthorization is something that must get done. The Prescription Drug User Fee Amendments (PDUFA) VI expires in September. Congress has already started stepping up that effort: both Senate HELP and House Energy and Commerce have held hearings over the past six weeks.
Mental Health: Also set to expire at the end of September are 32 programs on mental health and substance abuse at the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Health Resources and Services Administration (HRSA). In the House, Energy and Commerce had a hearing in early April that considered almost 20 bills that would reauthorize these programs. Over in the Senate, the Finance Committee's mental health working group finally put out their report at the end of March after months of bipartisan work. Their efforts focus on care integration, parity, telehealth, workforce, and youth. The Senate Health, Education, Labor, and Pensions (HELP) Committee has also announced their intention to reauthorize and expand these 32 programs.
Pandemic Preparedness: The Senate HELP pandemic preparedness working group has been looking beyond COVID to the next pandemic. They put out a discussion draft in January and legislation, the PREVENT Pandemics Act, in March. It missed getting attached to the FY22 omnibus, but there is strong bipartisan support for it.
Sequester Relief: The Medicare payments exemptions from sequestration cuts that had been extended by previous pandemic packages expired on April 1. The question now is whether Congress can and would do something retroactively on this relief. We anticipate the end of the year package as the most likely vehicle.
Drug Pricing: A priority for many on either side of the aisle, drug pricing is the subject of a wide variety of proposals. The President dedicated part of his 2022 State of the Union calling for congressional action on the matter. At the end of March, the House passed the Affordable Insulin Now Act, which would cap out-of-pocket insulin costs at either $35/month or 25% of insurance's negotiated price–by a vote of 232-193. In the Senate, it's been reported that Sens. Shaheen and Collins are working on their own legislation; they previously introduced a bill in 2019 that targeted insulin costs We have heard that drug pricing could be thrown into a slimmed down Build Back Better (reconciliation), though what exactly would be included is still up in the air.
Understanding what's on Congress' agenda is one thing but figuring out a vehicle to get it to the President's desk is another. There is the potential some of these efforts could be standalone pieces of legislation. However, finding a ride on another "must pass" bill would be easier. It's anticipated that there may be some form of another Ukraine package, and Majority Leader Chuck Schumer has already told the press that he wants global COVID aid and food security provisions to be included in it. However, we recall how the previous legislation had been considered to carry COVID relief before Republicans balked. Build Back Better, or as it's being touted by some "Build Back Slimmer" or just simply another reconciliation, could include some health provisions. If the COVID package is unable to get the requisite Republican support, Democrats would likely have to attach it to such a reconciliation bill.
The ball is not only in Congress' court. HHS and other agencies, of course, have their regular rulemaking processes. We anticipate the implementation of the No Surprises Act on surprise medical billing will remain a hot topic. However, the thing we will be watching is April 15, the date when the public health emergency (PHE) declaration is set to expire. The PHE has already been extended eight times. There is the political desire to move past the pandemic, but the emergency declaration does provide coverage and flexibilities. Many expect HHS will delay the expiration another 90 days to July.
We are also keeping a watchful eye on other current events that could influence the appetite and direction of policy. Although many want to put COVID in the rearview mirror, any spikes or potential variants obviously remain a concern and could spur further legislative action. The rollout of 9-8-8, the National Suicide Prevention Lifeline, in July could steer any of the mental health efforts. Ketanji Brown Jackson's confirmation has dominated the news in recent weeks, but we anticipate two upcoming Supreme Court decisions could cause even bigger waves in the healthcare arena. American Hospital Association v. Becerra challenges the HHS rulemaking which reduced reimbursement rates for 340B hospitals, but in agreeing to hear the case, the Court opened the opportunity to revisit the Chevron deference doctrine in which the judiciary typically defers to administrative discretion of ambiguous laws. The buzzier Dobbs v. Jackson Women's Health Organization is already causing a ripple effect even before a ruling comes down: with the prospect of Roe v. Wade potentially being overturned, over 20 states have mechanisms in place to ban abortion quickly as soon as a ruling comes out.
Despite some clear "must happens," the unknowns of 2022 – how will the Supreme Court decisions impact policy, what can Congress agree on, and when will such actions take place – continue to mount. With the start of the new Congress–January 3–on the horizon, the one certain diagnosis we can make is that it's going to be a bumpy ride between now and then.