The Centers for Medicare and Medicaid Services (CMS) has been doing victory laps since announcing discounts on August 15 for 10 of the most expensive Medicare Part D drugs, a change that is set to go into effect in 2026.

These discounts, called maximum fair prices (MFPs), kick off annual negotiations between the CMS and drug manufacturers. The negotiations were made possible by the Inflation Reduction Act (IRA), which also brings other changes such as Medicare Part D benefit redesign.

It might seem like all good news, but Big Pharma isn’t happy.

Merck, Johnson & Johnson (J&J), Novo Nordisk, and more filed lawsuits, claiming that the negotiations are unconstitutional, though none have succeeded yet. Academics and industry groups, on the other hand, say that while it’s possible drug companies won’t feel much of an economic impact from the discounts for a while, insurance plans, consumers, and pharmacies might.

Keep reading here.—CC

Did you know that 25% of all children’s asthma hospital visits occur in September? Between going back to school, an increase in viral illnesses, and ragweed pollen, hospitalizations for asthma peak about 18 days after Labor Day for school-age children.

Prepare your patients for the most asthmatic time of year by using ImmunoCAP™ Specific IgE tests. They help you optimize your respiratory allergy diagnosis while aiding patients in understanding their triggers.

And thanks to the Lab Ordering Guide, you can easily find the test codes for the respiratory allergen profiles from the labs that you already use. All you have to do is enter your zip code and choose the profile type you’re looking for.

Keep the Lab Ordering Guide in your back pocket and diagnose more confidently this asthma season.

Earlier this month, the FDA took Lykos Therapeutics from flying high to a bad trip.

On August 9, the FDA declined to approve Lykos’s MDMA therapy, and the drug company stated in a release the same day that the agency requested it conduct another Phase 3 trial to “study the safety and efficacy of midomafetamine [MDMA].” Lykos’s MDMA treatment was designed to help patients with post-traumatic stress disorder (PTSD) and other mental health conditions.

The decision, which came despite support from Congress, disappointed not just Lykos, formerly known as MAPS Public Benefit Corporation, but also advocates who were hoping for psychedelics to be approved.

“I was really disappointed, especially for the many PTSD sufferers who hoped the Lykos treatment would soon be available to them, but the decision wasn’t a total surprise,” Bob Jesse, who is an advisor for the UC Berkeley Center for the Science of Psychedelics, told Healthcare Brew in an email. “The FDA had tons of input to interpret, and depending on how they weighed various parts of it, they could probably have justified [any] approval, delay, or rejection.”

The FDA’s exact reasons have not been made public, but Lykos said in its release that it received the complete response letter (CRL) from the agency. The company declined to comment on the matter, though some experts say that the future of psychedelics remains strong.

Keep reading here.—CM

Walgreens is teaming up with the federal government on a multimillion-dollar gamble to diversify clinical trials.

On August 19, Walgreens announced a partnership valued up to $100 million with the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), over a five-year span.

BARDA will use the chain’s clinical trial platform and pharmacy sites as part of its Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program, according to a Walgreens press release.

The partnership is focusing on decentralized trials—which are done outside of traditional clinical sites and in real-world environments, like a patient’s home or local pharmacy—as a step toward solving what advocates say is a diversity problem in clinical trials. In 2020, only 8% of new drug trial participants were Black, for instance, according to a 2022 analysis that called for decentralizing sites and using digital tools to make trials more accessible for people who face barriers like a lack of reliable transportation.

Keep reading here.—CC

Here’s to a healthy tomorrow. If you’re a leader in the healthcare industry, you won’t wanna miss HLTH’s 2024 event in Las Vegas from Oct. 20–23. This year’s theme? Boldly stepping into health’s future. Network, gain insights on cutting-edge trends, and more. Leaders in tech, pharma, consumer healthcare, and more will be there. Will you?