INNOVATION OVERSIGHT — House Republicans want greater oversight of CMS’ Center for Medicare and Medicaid Innovation, Robert reports.
Several GOP lawmakers took aim at CMMI for its plan to slash Medicare payments to drugs cleared under the Food and Drug Administration’s accelerated approval program.
At a House Ways and Means Health Subcommittee hearing on Wednesday, Republicans said the center, which tests changes to Medicare reimbursements in search of savings, harms access to innovative drugs. They called for greater guardrails in the center.
The new approach at issue: The concerns center on a proposed model CMMI floated in February that cuts Medicare payments to accelerated approval drugs. The goal is to entice drug companies to finish confirmatory trials of the products that get to market faster if they address an unmet medical need.
Chair Jason Smith (R-Mo.) said the model will slow innovation for accelerated therapies if Medicare reimbursement is in doubt.
CMMI has yet to offer more details on the model, including its start time or the level of pay cuts.
But Rep. Vern Buchanan (R-Fla.) told POLITICO that he hopes to put together legislation on the issue.
Longstanding conflict: Republicans have long held a grudge against the center created under the Affordable Care Act. During the Obama administration, several House lawmakers lamented the center’s push for mandatory savings models. The Trump administration’s bid to use CMMI to lower drug prices to match those paid by other countries drew a similar pushback from the GOP back in 2018.
Now, Republicans are questioning the overall benefit of the center, which has started incorporating health equity measurements into its model efforts in recent years.
“CMS has tested more than 50 models since its creation,” said Rep. Adrian Smith (R-Neb.). “Despite millions of taxpayer dollars spent setting up and evaluating these models, only six of these were found to have delivered statistically significant savings.”
CMMI launched a strategic refresh in 2021 that set an ambitious goal to have every Medicare fee-for-service beneficiary in an accountable care relationship by 2030. The center also wants to develop new models that focus not just on delivering savings to Medicare but also improvements to care and health equity.
WELCOME TO THURSDAY PULSE — and to the end of the Covid public health emergency.
TODAY ON OUR PULSE CHECK PODCAST, host Ruth Reader talks with Katherine Ellen Foley about the decision by expert advisers to recommend that the FDA approve the first over-the-counter birth control pill, Opill.
FIRST IN PULSE: CMS HASN’T CHANGED ITS ACCELERATED APPROVAL VIEW — The Centers for Medicare and Medicaid Services clarified this week that it hasn’t updated its approach to covering new therapies the FDA approves before trials confirm their full benefits to patients, Katherine reports.
At a recent House E&C Subcommittee on Health hearing, CMS Administrator Chiquita Brooks-LaSure said that “[CMS] considers accelerated approval in a different category” than traditional FDA approval.
The FDA grants accelerated approval to speed up the process of bringing new therapies to market if a severe need is unmet and some data shows the treatment would likely benefit patients. The agency grants treatments traditional approval if data confirm they benefit patients, which can take longer.
If CMS were to consider treatments that receive accelerated approval to be less rigorously evaluated, it could jeopardize coverage for those drugs — including many cancer treatments.
On Tuesday, Brooks-LaSure, responding to a letter from Washington-based advocacy group Friends of Cancer Research, stated that the agency hadn’t updated its approach to treatments that receive accelerated approval. “We will continue to work with you and other interested stakeholders to make sure these treatments get to patients who need them as part of President Biden’s Cancer Moonshot initiative,” she wrote.
RECOMMENDING THE OTC PILL — Two panels of expert advisers to the FDA unanimously agreed that the benefits of a new over-the-counter birth control pill outweigh the risks, Katherine writes.
Over two days, the panels considered the evidence presented by HRA Pharma, maker of Opill, and concluded in a 17-0 vote that the pill’s benefits of safely preventing unwanted pregnancies outweigh the potential health risks to consumers.
FDA scientists have shared concerns about the drug’s safety and efficacy, even amid pressures to expand contraceptive options in post-Roe America.
But the vote doesn’t equal government approval. The recommendations aren’t binding, though the FDA often follows them. The agency is expected to decide this summer.
The administration’s decision will come after vows to “follow the science” for drug approvals and defend reproductive rights, our Alice Miranda Ollstein and Katherine report.
HEALTH PAYMENTS ON THE CHOPPING BLOCK — If a debt ceiling deal isn’t reached and the U.S. defaults on its debt, Social Security and Medicaid payments could be in question, POLITICO’s Caitlin Emma reports.
The Bipartisan Policy Center, a think tank that specializes in predicting the “X-date” for when the government officially can’t pay its bills, said the U.S. could default on its bills between early June and early August.
Defaulting could keep about $50 billion in Social Security benefits from going out in the first half of June — and more than $20 billion in payments to Medicaid providers could face the same fate.
Also at risk: $6 billion in federal salaries, $12 billion in veterans benefits and $1 billion in Supplemental Nutrition Assistance Program benefits.
MORE GLIMPSES OF UNWINDING — While Medicaid data from Arkansas released earlier this week has consumer health advocates worried, new numbers from Arizona paint a less dire picture, Megan reports.
In April, Arizona redetermined coverage for roughly 76,000 people who had remained enrolled in the state’s Medicaid program because of pandemic protections, according to data released by the state Medicaid agency Wednesday. Between that pandemic-protected group and the state’s usual monthly renewals, about 20 percent of people lost coverage. That’s about a third of the 54 percent who lost coverage in Arkansas over the same period.
Idaho reports that about 60 percent of its pandemic-protected Medicaid population that completed the renewal process had lost coverage. About 44 percent of the same group in Arizona has done the same.
Comparisons should, however, be taken with some skepticism. States don’t have to report their unwinding data publicly — just to CMS — but those that do parse the numbers in slightly different ways that make it difficult to make apples-to-apples comparisons.
Still, the state data offer an early glimpse at how the Medicaid redetermination process is going as states comb through their health insurance rolls for the first time in three years. CMS has said it will report national redetermination numbers, though that data isn’t expected until the summer.
DESANTIS’ COVID OBSESSION — While much of the country moves on from the pandemic, Florida Gov. Ron DeSantis can’t stop talking about it, POLITICO’s Arek Sarkissian reports.
With the public health emergency ending today, DeSantis has been crisscrossing the country touting his handling of the virus and criticizing lockdowns.
And he’s looking to the future, supporting policies that would outlaw future mandates like those that became commonplace through the pandemic.
That could hint at the messaging in a future DeSantis campaign.
It could also preview arguments his opponents may make: that his prolonged focus on Covid is merely political theater and the policies he’s railing against saved lives through a public health crisis.
NOT PAYING FOR THE APP — New treatments for chronic conditions like opioid addiction, ADHD and insomnia are not just in pill bottles — they’re on your smartphone.
But that doesn’t mean the government will cover them, even as tech entrepreneurs insist their digital therapeutics are next on the horizon for treatment, POLITICO’s Ruth Reader and Ben Leonard report.
Though the FDA has cleared dozens of these software-based therapies — which include apps and video games — CMS can’t reimburse providers, partly because Congress hasn’t approved new billing codes that describe the therapy. Those determinations affect private insurers’ decisions as well. Now there’s a bipartisan push to change that, but it comes as many of the firms are in a race to survive.
Their plight underscores the quandary facing regulators who must balance the need for new treatments with the expense, especially when there’s limited evidence the treatments work and health care costs are spiraling.
The Atlantic reports on a surprising commonality shared by the latest Covid variants.
Bloomberg reports on the secret White House team working to tackle drug shortages.
STAT reports on a human genomics project aimed at being more useful for diverse populations.