What We’re Reading: TX Judge Rules Against ACA PrEP Coverage; FDA Advisers Recommend ALS Drug Approval; Walmart, UnitedHealth Partnership

A Texas judge ruled that HIV pre-exposure prophylaxis (PrEP) coverage under the Affordable Care Act is unconstitutional; an FDA advisory panel recommended the approval of an experimental drug for amyotrophic lateral sclerosis (ALS); Walmart and UnitedHealth Group are collaborating to provide preventive health care for older Americans.

Texas Judge Rules Against HIV PrEP Coverage Under ACA

US District Judge Reed O’Connor ruled Wednesday that required coverage of HIV pre-exposure prophylaxis (PrEP) under the Affordable Care Act (ACA) is unconstitutional and violates a Texas health care employer’s religious beliefs, the Associated Press reported. O’Connor also ruled that the US Preventive Services Task Force that recommends coverage violates the appointment clause of the US Constitution, but the ruling’s impact beyond the plaintiffs was not clearly defined. Soon after, The Hill reported the Biden administration’s announcement that it is reviewing the ruling, calling the ACA “the law of the land” for more than a decade. “That guarantee is critical to the health and wellbeing of millions of Americans, particularly LGBTQI+ Americans, people of color, pregnant women, and others,” Karine Jean-Pierre, White House press secretary, wrote in a Twitter thread. “The Administration is committed to protecting Americans’ access to free preventive health care and building upon the successes of the Affordable Care Act.”

Advisers Recommend FDA Approval of ALS Drug AMX0035

Independent FDA advisers voted 7 to 2 Wednesday to recommend the approval of experimental amyotrophic lateral sclerosis (ALS) drug AMX0035, The Washington Post reported. The drug, which is considered safe and has gained support from patients with ALS and advocates, is manufactured by Amylyx. The FDA panel originally recommended against its approval in March 2022 due to insufficient efficacy data. However, additional data and and a vow by Amylyx to pull the drug if a larger study does not demonstrate its efficacy improved its case for FDA approval, and the panel also considered the severity and lack of treatments for ALS. The FDA is expected to decide whether to approve the drug by September 29.

Walmart, UnitedHealth Group Collaborate in Value-Based Care Initiative

Walmart and UnitedHealth Group are partnering to provide preventive health care for people 65 years and older, as well as virtual health care services for people of all ages, Reuters reported. The partnership will focus on value-based care and preventive care for common conditions among older adults, including heart disease and diabetes. In January 2023, services will initially be offered at 15 Walmart Health locations in Georgia and Florida. Walmart's health care personnel will use UnitedHealth’s Optum, which gives data analytics on patients to providers. Under the partnership, Walmart and UnitedHealth Group are also expected to launch a cobranded Medicare Advantage plan in Georgia.