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Friday, Apr 24 2026 9:09 AM

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Feds Want To Fast-Track Medicare Coverage For Certain Medical Devices

To be eligible, certain breakthrough devices would have to be part of an Investigational Device Exemption study enrolling Medicare beneficiaries and assessing clinical outcomes agreed upon by the FDA and CMS, Modern Healthcare reported. Plus, President Donald Trump strikes a most-favored-nation deal with the final pharmaceutical holdout.

The Centers for Medicare and Medicaid Services and the Food and Drug Administration on Thursday announced a quicker way for certain medical devices to gain Medicare coverage. The devices must be FDA-designated Class II and Class III breakthrough devices, and Class II devices must participate in the FDA’s Total Product Life Cycle Advisory Program — a voluntary program that offers early agency support to help bring innovative devices to market faster. CMS would work early with medical device companies during pivotal trial design to ensure trials generate the evidence needed for Medicare coverage decisions. (Dubinsky, 4/23)

The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release. The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday. (Dubinsky, 4/23)

Highly lethal cancers received disproportionately less federal funding compared with other cancers that have better survival odds, according to a study by researchers at the National Cancer Institute. (Bankhead, 4/23)

On the high cost of prescription drugs —

President Trump unveiled a deal with drugmaker Regeneron on Thursday for the company to voluntarily cut prices, the final manufacturer to commit to the White House’s “most favored nation” plan to lower U.S. costs in line with other developed nations. Under the agreement, Regeneron said it will reduce prices for its current and future medications sold to Medicaid. It will also offer its cholesterol drug Praluent for a discounted price of $225 through the TrumpRx.gov website in exchange for tariff relief and other incentives. (Weixel, 4/23)

President Donald Trump, who helped push the term “ fake news ” into the mainstream, now seems to have a new favorite subject: fake math. During a Thursday event announcing a deal with drugmaker Regeneron to lower the cost of its pharmaceutical products, Trump defended his past claims that prices on prescription medications had been cut by well over 100% — something that is mathematically impossible without manufacturers dropping prices to zero and then presumably paying consumers to use their product. (Weissert, 4/24)

Legislators in two states have resisted efforts to restrict prescription drug affordability boards, the controversial panels that are designed to function as rate-setting authorities and place limits on the cost of prescription medicines. (Silverman, 4/23)

On the Trump administration's reclassification of medical marijuana —

Sen. Tom Cotton (R-Ark.) on Thursday criticized the Department of Justice’s (DOJ) decision to downgrade state-approved medical marijuana to a less dangerous drug. “Marijuana today is much more potent than just ten or twenty years ago, leading to increased psychosis, anti-social behavior, and fatal car crashes,” Cotton wrote on the social platform X. “Arkansans don’t want more dangerous drugs obtained more easily,” he continued. “A change to marijuana’s drug classification is a step in the wrong direction.” (Davis, 4/23)

In many states, it is already easy to get marijuana. With the Trump administration’s move to reclassify the drug as less dangerous, it is about to get even easier. But doctors and researchers say marijuana can pose real risks to people’s health. The major concerns for adults are addiction and mental-health problems, particularly anxiety. These risks have become more of an issue in recent years as products with high levels of THC, the main psychoactive component of cannabis, have become widely available and popular. (Petersen, 4/23)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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