December 21, 2022
Good morning! Unless something blows up with the omnibus, this will be our final newsletter of the year.
- Will there be fake drama around the final passage? Of course. But if there's real drama, or any sudden health care changes, we'll be back in your inboxes to tell you what we're hearing. Otherwise, we'll see you Jan. 3!
- Thanks for joining us for our launch. Here's to very few Christmas Day sessions in our future. Happy New Year!
1 big thing: Omnibus cutting-room floor
Significant health care changes ended up in the omnibus package — but not everything people wanted, which means there's a lot that could come back next year.
- Here are some of the policies that ended up on the cutting-room floor.
COVID funding: The White House’s roughly $10 billion COVID-19 funding request did not make the cut. Republicans have argued for months that more money is not needed, pointing to the billions already provided in previous relief bills.
- The White House, though, had said the money could have been used in part on next-generation vaccine development to better fight new variants.
- Our thought bubble: It’s tough to see how this funding will have a better chance next year with a GOP House — unless a new variant dramatically changes the situation and the politics.
Prior authorization: The package left out a popular bill that would streamline Medicare Advantage utilization management requests. The bipartisan bill passed the House in September, but its price tag came in higher than expected, which stopped its progress in the Senate.
- Advocates anticipated the cost would come down after CMS proposed a rule on prior authorizations earlier in December, but the Congressional Budget Office didn’t rescore the bill in time, said Peggy Tighe, a health care lobbyist at Powers Pyles Sutter & Verville.
- Recent CMS regulations did capture a lot of advocates’ work this year, but “we definitely agree that these reforms need to be codified and we will work towards that,” Tighe said.
VALID Act: The measure aiming to modernize a patchwork of regulation of diagnostic tests was left out amid opposition from academic medical centers, who said it would impose burdensome new regulations.
- Backers in Congress said they would keep pushing next year. FDA spokesperson James McKinney told Peter the agency is "disappointed" VALID was not included, adding: "All options are on the table. One of those options is administrative action, which could include rulemaking."
- A spokesperson for Sen. Michael Bennet, one of the sponsors, said he would be “encouraging FDA Commissioner [Robert] Califf to take administrative action under his current authorities.”
- Rep. Larry Bucshon, another sponsor, said in a statement he would pursue "all angles to get this critical legislation signed into law” in the next Congress.
PBMs: A transparency provision from a bipartisan House mental health package that passed the chamber this summer would have required PBMs to provide detailed reports about costs, rebates and discounts to group health plans.
- Sen. Chuck Grassley told Victoria on Tuesday that he's going to keep pushing for PBM transparency next year. A House GOP aide confirmed that Energy and Commerce will revisit the PBM transparency issue in the new Congress.
- Meanwhile, the Pharmaceutical Care Management Association, the PBM advocacy group, said in a statement that “as designed, the legislation would ultimately only result in allowing drug companies to further game the system.”
- PCMA added that the PBM industry is “a strong proponent of transparency,” and PBMs already have to report information on the top 50 drugs by spend and volume due to a transparency requirement in a 2020 omnibus bill.
Dietary supplement regulation: Consumer groups like the Pew Charitable Trusts and the Center for Science in the Public Interest had been advocating for a provision that would have required manufacturers to submit dietary product labels to the FDA, resulting in more transparency about what goes into supplements.
- Its failure wasn’t really a surprise, since Sen. Richard Burr told us in November that there was “no” chance of dietary supplement regulation in the omnibus.
Title X: The federal family planning program won’t get any additional appropriations for the ninth year in a row. A bill introduced by Sens. Elizabeth Warren, Patty Murray and Tina Smith in July would have increased the program’s funding to $500 million annually for the next 10 fiscal years.
Reality check: Even the most bipartisan of policies on this list faces an uphill battle to passage in a divided Congress next year.