Trump admin mails $500 ACA 'refund' checks and promises $90 checks for Medicare enrollees

The Trump administration last week started mailing out $500 Affordable Care Act (ACA) "refund" checks to nearly 1 million Americans. According to an administration official, checks will start going out to more than 950,000 Americans across 30 states that use the federal ACA marketplace.

"For years, the Biden administration overcharged you to fund the operation of HealthCare.gov," Trump wrote in a letter accompanying the checks. "That money belongs to hard-working Americans, not the Government, and now I'm returning it to you!"

Currently, there are 19.2 million people enrolled in ACA coverage, meaning only a small fraction are eligible for the rebates. People who receive premium subsidies are not eligible nor are people who live in states that operate their own exchanges.

Meanwhile, on Friday, Trump said that he plans to send $90 checks to Medicare Part B enrollees to help pay for Medicare premiums. He added that the money would come from the Medicare Improvement Fund, which he described as a "Slush Fund."

"I am pleased to announce that my Administration will, immediately, begin sending 'Checks' of nearly $100 to over 20 MILLION wonderful Seniors to help pay for their Medicare Part B premiums, which we have already reduced by significant amounts," Trump said in a Truth Social post.

In a Q&A from CMS, the agency said utilizing the Medicare Improvement Fund for rebates makes sense as "the best way to improve Medicare is to put healthcare dollars back where they belong — in the hands of our Medicare beneficiaries — and make coverage more affordable."

(Weixel, The Hill, 9/30; Berkowitz, Axios, 10/3; Goldin, Associated Press, 10/3; Minemyer, Fierce Healthcare, 10/5)

HHS announces plan to speed up clinical trials

HHS last week announced a plan to reimagine the way clinical trials are designed, hoping to significantly reduce the time and money it takes to develop new drugs.

The plan, called the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, will feature teams focused on bringing drug candidates through experimental clinical trial processes. Teams will be selected through a bidding process.

The program, which will be run by the Advanced Research Projects Agency for Health (ARPA-H), will start by soliciting ideas from teams that have a drug sponsor. Winners will then receive funding and support over the course of five years.

Specifically, ARPA-H is looking for proposals that will innovate in three areas: Phaseless trials that allow faster trials with fewer patients, the ability to analyze data in real time during the trial rather than after the trial ends, and using automation to reduce inefficiencies.

Teams will also most likely include medical centers or other clinical sites, biostatisticians, and companies that can predict drug outcomes on a computer.

Daria Fedyukina, manager of SURPASS, said FDA has been included in the planning of the program so "there won't be any surprises for regulators in this."

Fedyukina added that the goal of the program "is to develop the tech that is missing and blaze the trail of a new clinical trial paradigm" and that while "it's hard to put a number to how much cost savings or time savings we can achieve, there is no reason why we cannot target, let's say, a 10x reduction in the cost of clinical development for a drug."

(Owens, Axios, 9/30)

3 GOP states challenge abortion 'shield laws' at Supreme Court

During the COVID-19 pandemic in 2021, FDA lifted its requirement that patients visit a medical provider in person to obtain the abortion medication mifepristone. That decision was made permanent in 2023 and spurred the creation of multiple telemedicine abortion services.

Following the Supreme Court's overturning of Roe v. Wade in 2022, many conservative states implemented abortion bans, which led several other states to pass shield laws protecting the ability of abortion providers to prescribe pills via telemedicine and ship them to patients in states with abortion bans.

There have also been other lawsuits targeting abortion care. For example, Louisiana sued FDA earlier this year over the agency's decision to remove the in-person dispensing requirement for mifepristone. The state argued the decision was based on inadequate or flawed data and that making abortion pills available by mail has allowed patients to access the medication despite the state's near-total abortion ban.

Although a panel of the U.S. Court of Appeals for the Fifth Circuit unanimously ruled in favor of Louisiana, the decision has since been appealed to the U.S. Supreme Court. In May, the Supreme Court  allowed mifepristone to be accessible via telemedicine while the lawsuit plays out.

(Mulvihill/Hanna, Associated Press, 9/30)

Hundreds of postmarket studies ordered by FDA are still not done

Hundreds of "postmarket" studies — additional safety research required by FDA as a prerequisite for a drug's approval — have been delayed or have yet to be planned, even years after a drug was allowed to be sold on the market, according to an investigation from KFF Health News.

In its investigation, KFF discovered that hundreds of postmarket studies are currently listed as delayed, and in some cases, the work was delayed by over a decade, or the manufacturer was still developing a plan for the study.

In one instance, FDA approved the drug Tavneos to treat a set of rare autoimmune diseases, despite arguments from some agency experts that the manufacturer had provided "limited safety data."

FDA originally approved the drug in 2021 but required the manufacturer to conduct additional postmarket safety research once the drug was on the market. According to KFF, as of last fall, only 21 of the planned 300 patients in the postmarket study had been enrolled.

Meanwhile, FDA has identified dozens of cases of liver damage that are "possibly" or "probably causally associated" with Tavneos.

Emily Hilliard, a spokesperson for HHS, said postmarket studies can experience delays for legitimate reasons. "Assessing the significance of any delay requires a case-specific review," she said, adding that the fact a study is delayed "should not be treated as evidence that a product has an unresolved safety or effectiveness issue."

A spokesperson for Amgen, which makes Tavneos, said the company is still working on the postmarket research and that it "remain[s] committed to completing this important study."

(Hilzenrath, KFF Health News, 9/18)