The unexpected alliance lobbying for Medicare to cover obesity drugs

It's not every day that the pharmaceutical industry, the NAACP, a cancer center, and a nonpartisan think tank are all lobbying to achieve the same policy goal. But an effort to expand Medicare coverage for obesity drugs has managed to unite them along with many more groups across the health-care industry, I report in a new story out this morning.

Medicare is prohibited by law from paying for the buzzy new drugs that promise to help people with obesity lose weight. Lawmakers banned coverage of obesity drugs when the program's prescription drug benefit was created in 2003, and there's been a decade-long legislative push to reverse the prohibition.

I talked with a broad range of groups advocating for more coverage for obesity treatments about the challenges they face, the state of play on the Hill, and where they see the debate going next. Regardless of how this issue plays out this year, obesity treatment is going to be an important issue for Medicare to grapple with going forward.

implementation watch

4 big questions about FDA's accelerated approval reforms

The year-end government spending bill included significant reforms to the FDA's accelerated approval process following the kerfuffle over Biogen's Alzheimer's drug Aduhelm. My colleague John Wilkerson breaks down the biggest questions about how the new law will be implemented.

Some topics to watch: FDA can now criminally prosecute drug makers that don't complete confirmatory studies "with due diligence." It's easier for the FDA to pull drugs off the market. And the FDA doesn't have to demand that confirmatory studies begin before a drug's approval, but it can. Read more for details, and for a rundown of what FDA Commissioner Robert Califf has said on the topic.

In other news, be sure to follow along with my colleagues Helen Branswell and Matt Herper on STAT's website today, where they will be live-blogging the FDA advisers' discussion starting at 8:30am ET today about making Covid-19 vaccines matched to current virus strains a regular, once-a-year shot.

Public health

CDC restructures amid criticism of pandemic response

CDC director Rochelle Walensky is consolidating certain offices, opening new ones and directing the sprawling agency's various heads to report to her directly in a bid to address criticisms about the agency's Covid-19 response. The restructuring, announced during a staff meeting this week, comes as think tanks and lawmakers mull how to shake up the sometimes slow-moving agency, which was plagued by early missteps on both coronavirus testing and data gaps.

The changes include fusing the office for state, tribal and local support with the surveillance and epidemiology department, starting a health equity office, and creating a public health data office that will spearhead efforts to modernize data collection, said a CDC staffer who attended the meeting. The director is also elevating the CDC's lab science and safety department to report directly to her office, where a seven-person team — including the heads for global health, policy, and science as well Walensky's new deputy, former Maine CDC Director Nirav Shah — will guide decisions.

Walensky is reorganizing the agency "so that it can respond faster and communicate its science and research more clearly," said deputy press secretary Kathleen Conley, who added that this is "one step in a series of efforts" to strengthen the CDC.

fact check

The Biden administration's no good, very bad insulin numbers

As astute consumers of health policy news, D.C. Diagnosis readers may have come across a report HHS released this week touting that 1.5 million Medicare beneficiaries would have saved an average $500 per year on their insulin if the Inflation Reduction Act's $35 per month cost-sharing cap had been in place in 2020. President Biden tweeted the number out, and local and national news outlets repeated it.

The big problem with that study is that 2020 numbers aren't very relevant to the IRA's impact on what Medicare patients pay for insulin at all, because they don't reflect an insulin cost reduction model that went into effect in 2021 that reduced costs for a lot of patients. The Part D Senior Savings Model conceived during the Trump administration allowed Medicare drug plans to offer insulin products at $35 per month starting in 2021. By 2022, CMS' own data shows that more than 800,000 seniors who use insulin were already enrolled in the plans offering co-pay caps.

When I asked HHS officials about the discrepancy, ASPE Associate Deputy Assistant Secretary Nancy DeLew said the point was "well taken" and the 2020 data was the most recent available when they started the analysis. ASPE's Deputy Assistant Secretary for Health Policy Ben Sommers said "there might be some partial overlap" in the numbers, but it's unlikely that all of the 800,000 patients are being double counted.

It's true that the co-pay caps will likely reduce costs for some seniors who use insulin this year. But there isn't an accurate estimate of marginal impact yet.

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