| | | |   | Happy Tuesday and various holidays, D.C. Diagnosis readers! Congress once again has said – how about a budget for Christmas? It’s not over until the bill gets to Biden though, so keep sending tips and updates to sarah.owermohle@statnews.com and my other infatigable D.C. colleagues, Rachel Cohrs and John Wilkerson. | | | Some takeaways from Congress’ big bill Lawmakers are finally coalescing around a sweeping end-of-year package that could drastically expand federal coverage for children and mental health, extend pandemic-era telehealth and home care provisions, and lower barriers to addiction care. But along the way, the omnibus’ provisions would trim Medicare physician payments, delay testing payment changes, and bump people off Medicaid.
A rundown of what to know so far, from Rachel, John, and me:
Medicare. Physicians will see a 2% payment cut next year, negotiated down from 4.5%. But that grows to a 3.5% cut in 2024. At the same time, there will be 5% incentive payments for doctors who use value-based care models.
The bill would also extend an at-home care program by two years and expand behavioral health coverage.
Medicaid. Democrats and Republicans reached a deal that lets states kick ineligible people off their Medicaid rolls in April, potentially before a freeze instituted by the public health emergency ends.
As part of that agreement, Democrats scored wins to ensure children stay on the rolls for a year but fell short of ensuring that every new mother on Medicaid also gets a year of postpartum coverage, leaving 17 holdout states to decide their own plans. The expectation is that kicking people out of the program will unlock some savings that can be put towards children and postpartum care.
The FDA. Democrats also finally got reforms to the agency’s accelerated approval process and clinical trial diversity efforts into the package after they were dropped from FDA reauthorization earlier this year, but a major reform to diagnostic oversight was dropped.
People familiar with the discussions said lawmakers scrapped the VALID Act after Rep. Cathy McMorris-Rodgers (R-Wash.), in line to lead the House Energy and Commerce Committee next year, raised concerns about giving FDA more regulatory power. Meanwhile Commissioner Robert Califf has virtually pledged to do it anyway through rulemaking, a possibility that former commissioner Scott Gottlieb sketched out in a recent Twitter thread. Read more here and stay tuned for actual votes this week. | Accelerated approval tweaks drop drug industry-approved provisions A bill that makes it easier for the Food and Drug Administration to withdraw drugs that were approved under an accelerated timeline also dropped provisions the industry had opposed, three drug lobbyists told my colleague John. The legislation, spurred by the fracas over the Alzheimer’s drug Aduhelm, is missing earlier language that would have required companies to enroll clinical trials by the time they get accelerated approval. Lawmakers also stripped a requirement that product labels disclose that products have been approved using the accelerated pathway. John writes that the industry did lose a measure that would have explicitly stated that drug companies may use data from medical claims and insurance data to help confirm that drugs work in post-market studies. Read more here. | Why measuring value in cancer is key to achieving a more economically sustainable healthcare future The rising cost of cancer care is an undeniable challenge to a more economically sustainable healthcare future. One leading biotech company believes precise, widely accepted measures of value in cancer are urgently needed. They are actively involved in conversations — with payers, policymakers, and of course patient organizations — about how value should be defined and measured. Learn more. | Democrats wanted to force better maternal health. They didn’t quite make it. Yes, another omnibus item: Democrats struck a deal with Republicans to let states begin kicking ineligible people out of the Medicaid program in April — before a freeze linked to the public health emergency ends — as long as children now enrolled in the program were covered for a year after their circumstances change, and recent states’ moves to cover people for a year postpartum were made permanent.
The ultimate agreement is a far cry from Democrats’ desire to require every state, including 17 holdouts, to cover postpartum care through Medicaid for a year.
Case in point: Last week, the state of Texas issued a long-awaited report that found at least 118 women in the state died from causes related to pregnancy in 2019. Most of those deaths were preventable. The report’s top recommendation was a familiar but often-bypassed way to reduce maternal mortality: Ensure that all people have access to health care during pregnancy and for at least a year afterward. While 33 states opted into a Biden administration offering this April to extend Medicaid postpartum care for a year, most of the resistant states are in the Midwest. Several of those states have among the country’s worst maternal mortality rates, and many have implemented stringent abortion restrictions in the wake of Roe v. Wade’s upheaval. Texas is one of them. Such abortion restrictions, coupled with limited health-care access for pregnant people, create “an uneven playing field where the pregnant people and infants in their state – especially people of color – are more likely to die than their counterparts in states with access to public insurance and abortion care,” said Joanne Stone, president of the Society for Maternal-Fetal Medicine. | Who among us hasn’t been 13 and adrift? The Center for Tobacco Products, the 13-year-old center charged with regulating the millions of tobacco products currently on the market, doesn’t know what it wants to be when it grows up. That’s the takeaway from a new external review conducted by the independent Reagan-Udall Foundation.
The much-anticipated report, which was ordered by Califf, is chock-full of suggestions on how to address a number of long-standing gripes with the center that have been raised by both tobacco control advocates and the vaping industry – everything from the agency’s shifting standards for approving vapes to its slow and cautious approach toward companies that break its rules.
None of the findings is particularly becoming for the center, but nothing stings quite as bad as the report’s overarching findings: namely, that the office lacks clear goals and that’s impeding on its ability to effectively regulate the industry.
For more, check out my colleague Nick’s dispatch here. | What to read around the web today -
The list of the worst biopharma CEOs of 2022: No 'winner,' just accountability, STAT -
Why Democrats warmed to severing Medicaid eligibility from the Covid public health emergency, Politico -
A child’s insatiable appetite is linked to a single genetic mutation, STAT -
U.S. FDA lifts hold on Bluebird's sickle cell disease therapy, Reuters | | | Thanks for reading! More on Thursday,  | |
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