Cities sue to block ACA final rule from CMS

A lawsuit led by Columbus, Ohio as well as Chicago, Baltimore, and Pima County, Arizona, was filed recently against CMS challenging a rule finalized by the agency last month that would institute significant new policies in the ACA marketplace, including expanding access to nontraditional health plans and tightening eligibility requirements.

Specifically, the rule allows insurance companies to offer catastrophic plans, which were initially intended only for people younger than 30 or experiencing various hardships defined by the ACA, to more people and for up to 10 years.

The rule also:

• Permits health plans with no provider networks to operate on ACA exchanges
• Rescinds a requirement that a state establishing a new ACA exchange operate as a hybrid federal-state marketplace for one year before fully taking over
• Reduces the health insurance company user fee from 2.5% to 1.9% for federal exchanges and from 2% to 1.5% for state exchanges
• Tightens marketing standards, including creating requirements that agents and brokerages use standardized eligibility forms and that ACA enrollees personally affirm the information in applications prepared by third-party marketers is correct

In the lawsuit, the plaintiffs argue that the effects of the final rule are "directly contrary to the landmark legislation" due to potential coverage losses. They also argue that while the final rule aims to make care more affordable while managing administrative overhead, "the rule accomplishes the opposite" and creates "numerous" barriers to coverage instead.

(Minemyer, Fierce Healthcare, 6/8; Halleman, Healthcare Dive, 6/8; Early, Modern Healthcare, 5/15)

HHS allegedly wants access to Americans' health records

HHS is looking to acquire detailed, identifiable patient information from hospitals and clinics as part of HHS Secretary Robert F. Kennedy Jr.'s quest to research a link between vaccines and autism.

While HHS has not publicly announced any new projects involving medical records and autism or vaccine research, some public health leaders have told KFF Health News of meetings they've had where Kennedy's team has discussed accessing such data.

"Vaccine safety, or whatever words you want to use, has come up pretty consistently in those conversations," said John Kansky, CEO of the Indiana Health Information Exchange.

In addition, Kennedy previously told KFF Health News that health records are integral to investigating the cause of autism, vaccine safety, and chronic diseases.

"We need a good health record system, and one of the things that really surprised me most when I came into office is that there is — that the systems are broken," Kennedy said in an interview with KFF Health News in May. "We've had to go to the states and, luckily, we've got a lot of cooperation from the states, but we now have databases together that we can actually do the studies on. Those studies are in motion."

FDA launches study on abortion pill

FDA has launched a study on the abortion pill mifepristone, a drug that is currently used in most abortions in the United States and has been the subject of a lawsuit over the past three years.

Medication is currently the method used in almost two-thirds of abortions in the United States and is usually delivered through a two-drug regimen within the first 12 weeks of pregnancy. The first of those medications is mifepristone, which was first approved by FDA in 2000.

During the COVID-19 pandemic in 2021, FDA lifted its requirement that patients must visit a medical provider in person to obtain 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.

In April 2023, Judge Matthew Kacsmaryk ruled against FDA's approval of mifepristone, arguing that the agency didn't adequately review scientific evidence or follow the proper protocols when it approved the drug in 2000.

In response to Kacsmaryk's ruling, more than 200 pharmaceutical companies signed a statement calling for the reversal of the decision. In June 2024, the Supreme Court unanimously rejected the challenge to mifepristone, arguing the plaintiffs lacked legal standing to challenge FDA's decision.

Earlier this year, Louisiana sued FDA arguing the agency's decision to remove the in-person dispensing requirement 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, which a panel of the U.S. Court of Appeals for the Fifth Circuit ruled in favor of, unanimously.

The decision has since been appealed to the Supreme Court and the Court has allowed mifepristone to be accessible via telemedicine while the lawsuit plays out.

Trump administration officials told the Wall Street Journal that FDA is looking to conduct a robust study that will withstand legal criticism, and that the effort will likely take about six months. This step could pave the way for the administration to restrict how mifepristone is distributed and used, the Journal noted.

(Whyte, Wall Street Journal, 6/4)

Trump announces expansion of TrumpRx to include an additional 160 drugs

President Donald Trump on Friday announced that 160 additional drugs will be added to TrumpRx, the administration's direct-to-consumer drug platform, marking the second expansion in two months.

"I am pleased to announce that TrumpRx.gov is adding another 160 Prescription Drugs, at highly discounted prices, for a new total of over 800 of the most commonly-used Prescription Drugs," Trump wrote in a Truth Social post.

"TrumpRx.gov will now provide clear, transparent, and DISCOUNTED offerings for FOUR OUT OF FIVE of every prescription filled by Americans," he added.

The platform was launched in February with 43 prescription drugs treating a variety of conditions. Drugs are unable to be purchased directly from TrumpRx, but rather customers click a button stating they aren't enrolled in a government insurance program like Medicare and won't seek insurance reimbursement for out-of-pocket costs or count them toward a deductible and then receive a coupon they take to a pharmacy for a discount on their prescription.

(Brams, The Hill, 6/6)