| | | |   | Happy Tuesday, DCD readers! Please send news and tips about where the World Cup-predicting otter was when Japan lost yesterday. Health care news and tips also welcome, to Sarah.owermohle@statnews.com. | | | Drug overdose is a national crisis — but Congress isn't acting like it In a way, addiction is Congress’ favorite topic. Virtually every lawmaker has a bill, a story, a segment of their stump speech devoted to the country's ongoing drug overdose crisis. Any effort to tackle the opioid epidemic is, in theory, an uncontroversial, bipartisan slam-dunk.
In reality, however, lawmakers appear poised to let the 117th Congress expire without enacting any fundamental reforms to the addiction treatment and prevention system, my colleague Lev Facher reports. Even if Congress does move on some of the current legislative proposals on addiction, advocates say it'll fall dramatically short of what's needed in the face of 107,000 annual drug overdose deaths.
"Many members of Congress do walk the walk," one advocate told Lev. "But others talk the talk, and when it comes time to pony up — no. We’ve gone two years without any real, major policy changes in substance use disorders.” Read more here. | Speaking of the year-end dealmaking… While action on addiction issues looks modest, there’s also a bunch of other issues in play in the end of the year package.
Talks over FDA regulations are ongoing, and one of the most contentious issues getting hammered out right now is over how to regulate diagnostic tests used to screen blood and tissue. Text is being drafted to revise the VALID Act on the Hill, per lobbyists and congressional aides. Former FDA Commissioners Mark McClellan and Scott Gottlieb had an op-ed in STAT yesterday advocating for diagnostic testing reform, and also giving the FDA more authority to regulate cosmetics.
Other issues the STAT team has heard about from lobbyists include some extension of pandemic-era telehealth flexibilities, some relief for physicians facing Medicare pay cuts (though the docs might not get everything they want, due to cost constraints), mental health and pandemic preparedness legislation, some Medicaid policy governing the unwinding of the end of the public health emergency, as well as extending programs to support rural hospitals and maintain territories’ Medicaid programs. | PBMs help patients access safe and affordable treatments America’s pharmacy benefit managers, PBMs, continue their specialized work helping diabetes patients take their drugs safely and affordably. With a PBM on her side, Kaeana’s daughter, who lives with diabetes and a rare liver condition, gets her medications for $40 — not the $6,000 these prescription drugs would otherwise cost her. Hear Kaeana’s story. Learn more about how PBMs are working on behalf of all Americans living with diabetes. | Health costs frustrations hitting a boiling point? I kicked off my Monday with a Gallup/West Health panel on Americans’ mounting medical costs and their deteriorating confidence in the health care system.
Their latest report found that while 61% of Americans say they can safely afford their health care, most of them are white people, men in particular. Women and Hispanic people disproportionately skipped out on care or prescription medicines because they couldn’t afford it. And 37% of people said the costs weren’t worth the care they received.
While affordability hurdles sadly aren’t a surprise, I was struck most by that last data point. As I said during the panel, the longtime justification for high costs — whether for prescription drugs, surgeries or routine care — has been that America has the best and most innovative health care (even if that doesn’t pan out in better outcomes). If the average American doesn’t feel that’s true, the high-cost house begins to fall apart.
And in some ways, it already has — the polling was conducted in June, before Congress passed legislation allowing Medicare to negotiate certain drug prices. Myself and the other panelists, Families USA Executive Director Frederik Isasi and AARP Senior VP Jean Accius, talked about which beam falls next, with Isasi expressing home that hospital price transparency moves in the next Congress and Accius pushing to shore up options to build health equity, like telehealth services. | Another shake-up at a drug industry lobbying group The second half of 2022 has been tumultuous for drug industry lobbying groups. Congress passed a law that lets the government control drug prices, BIO’s president abruptly resigned, PhRMA lost its mojo, and now Dan Leonard, president of the generic drug lobby Association for Accessible Medicines is out of a job.
My colleague John Wilkerson scooped that Leonard was fired on Friday, though Leonard insisted in a statement Monday that he resigned. It doesn’t say why he left or where he is going.
The new law directing Medicare to negotiate drug prices, which AAM opposes, has stressed the entire drug industry. Three industry sources said AAM members are unhappy with Leonard’s handling of the drug pricing law — two lobbyists pointed out in particular that the group had been caught flat footed this summer, when Congress suddenly resurrected the drug pricing provisions that many thought it had abandoned. Another source familiar with AAM said the drug pricing law might be a convenient excuse to get rid of underperformers. Read more from John here. | The Biden administration’s march-in rights delay The NIH has taken a whole year to review and assess a request to use march-in rights to widen access to a pricey cancer treatment, my colleague Ed Silverman reports. That raises questions about whether the Biden administration will go further than past bureaucrats’ interpretations of their authorities to challenge patents over drugs’ prices.
At issue is the cost of the Xtandi drug for prostate cancer, which as of this past January has a list price of $156,000, and which was developed in part with federal government grants. Under a federal law known as the Bayh-Dole Act, a government agency that funds private research can require a company to license its patent to another party in order to “alleviate health and safety needs, which are not being reasonably satisfied.”
But the NIH’s evaluation continues to drag on. Tara Schwetz, acting principal deputy director at the NIH, told patients on Dec. 1 that the agency is still working on its review of the petition. Read Ed’s full analysis here. | What we’re reading - The health insurer will see you now: How UnitedHealth is keeping more profits, as your doctor, STAT
- Billions in Covid aid went to hospitals that didn’t need it, The Wall Street Journal
- Some Republicans say the midterms were a mandate for further abortion restrictions, Politico
- Before making unbiased pulse oximeters, researchers need a better way to measure skin tone, STAT
| | | Thanks for reading! More on Thursday,  | |
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