4 pending healthcare regulations for the Trump administration

1. Medicare Advantage

CMS is slated to issue the final version of its Medicare Advantage and Part D rule for the 2026 plan year that the agency proposed in November. While there isn't a deadline for finalizing the rule, CMS typically moves quickly to allow health insurance companies to adapt to any new policies before bidding to sell Medicare plans.

One of the most significant provisions from the proposed rule is the expansion of coverage of weight-loss medications in both Medicare and Medicaid programs, a change that would allow 7.5 million people enrolled in Medicaid and Medicare to access the drugs.

CMS also proposed stricter prior authorization standards as well as stricter standards for marketing, broker oversight, and supplemental benefits.

Earlier this month, over 70 groups issued a letter urging the incoming Trump administration to finalize the proposal covering weight-loss drugs under Medicare and Medicaid.

"We urge the incoming administration to finalize this policy through the rulemaking process. By extending access to obesity medications for people living with obesity who lack access to comprehensive evidence-based care in Medicare and Medicaid, the proposed CMS rule would address an urgent health crisis and leading contributor to the 'Unhealth' of Americans," the letter said.

According to Claire Ernst, director of government relations and public policy at Hooper, Lundy & Bookman, the change in administration gives healthcare stakeholders a fresh opportunity to push back against any policies they don't like.

However, Ernst added that the new potential leaders at CMS could feel compelled to advance a regulation that mostly adheres to the draft for the sake of expediency and could always issue more rules later.

Ernst added that Trump's record from his first term could provide hints as to how his new administration will treat this rule. For example, the proposed rule's limits on how debit cards are used to access supplemental benefits seem likely to remain since supplemental benefits costs are rising.

"They're being used a lot more, which is causing a lot more scrutiny," Ernst said. "The supplemental benefits oversight would be difficult for the Trump administration to completely ignore. It's a mounting issue."

Dan Mendelson, CEO of Morgan Health, said the Trump team will closely examine the weight-loss drug provisions and could scale them back without abandoning them entirely. "There's a lot of evidence that will need to be sorted," he said. "There are middle grounds here."

2. Remote prescribing of controlled substances

The Drug Enforcement Agency (DEA) has given providers limited authority to prescribe controlled substances remotely, but that is slated to run out at the end of the year.

Under the Support for Patients and Communities Act of 2018, DEA is required to create a registry of providers who prescribe Schedule II-V medications, decide which drugs can be prescribed remotely, and dictate how frequently patients must see clinicians in person to get those prescriptions.

The initial version of the rule would've required in-person visits for Schedule II drugs like Vicodin and OxyContin, while Schedule III-V drugs like Xanax and buprenorphine would require patients to see prescribers to seek refills after getting an initial 30-day dose remotely.

However, backlash from both providers and telehealth companies caused DEA to reconsider the regulation.

According to Nate Lacktman, a partner at Foley & Lardner and chair of the law and lobbying firm's telemedicine and digital health practice, the Trump administration will need to move quickly and ideally in collaboration with Congress on this regulation.

Trump's first administration was "bullish" on policies promoting digital health and telemedicine, including its permanent expansion of Medicare telehealth services in 2020, which suggests the second administration could be amendable to more favorable regulation, Lacktman said.

Under the proposed rule, providers and insurers using the independent dispute resolution process would pay CMS $150 per party, per dispute. The rule would also expand the types of codes and services that are able to be bundled together into one case and limit batched complaints to 25 items.

The law that includes the No Surprises Act was enacted under the Trump administration in 2020, and Trump himself was outspoken during his first term about making sure patients are protected from surprise medical bills. However, he was out of the White House by the time the first regulations came out in 2022.

According to Jeffrey Davis, health policy director at the consulting and lobbying company McDermott+, those fees and the batching proposals are subject to change under the new Trump administration, in part because federal courts have struck down previous attempts to increase the fees.

"Stakeholders feel that it's important for the Trump administration to at least review the rule and try to finalize what they believe to be process improvements," he said. 

4. Recent FDA regulations

FDA last week issued two new proposals, one requiring food manufactures to place new nutrition labels on the front of food and beverage products that would highlight the levels of salt, sugar, and saturated fat contained in the product, and another banning the use of Red No. 3, a food dye that has been linked to cancer in animals.

Red Dye No. 3 is used in dozens of candy, food, and beverage products, however, it has been found to be potentially carcinogenic in studies in animals and has been banned from use in cosmetics and topical drugs since 1990.

Meanwhile, FDA's new proposed food label would be a small black-and-white box similar to the Nutrition Facts box placed on the back of packaged goods and will detail whether a product has a "high," "medium," or "low" level of salt, sugar, or saturated fat.

A food would be defined as having a "high" level of salt, sugar, or saturated fat if the amount was equal to or greater than 20% of that nutrient's recommended daily value. A "medium" level would be between 5% and 20% of the recommended daily value, and a "low" level would be 5% or less.

The proposed new nutrition labels are open for comment through May 16 and it's unclear whether the Trump administration will finalize the rule. However, if the rule is finalized, manufacturers with $10 million or more in annual food sales would have to comply within three years of the rule's effective date, and smaller manufacturers would have four years to comply.