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April 11, 2022

Around the nation: Medicare restricts coverage of Alzheimer's drug

Daily Briefing

    CMS announced that Medicare will cover Biogen's Alzheimer's drug only for patients in clinical trials, in today's bite-sized hospital and health industry news from the District of Columbia, Maryland, and Oregon.

    • District of Columbia: Sens. Susan Collins (R-Maine) and Raphael Warnock (D-Ga.) on Thursday tested positive for the coronavirus after attending the Thursday afternoon confirmation vote of Judge Ketanji Brown Jackson to the Supreme Court. Collins, who was wearing a KN-95 mask during the vote, was one of the few lawmakers wearing a mask at the event. She is currently experiencing "mild symptoms" and plans to self-isolate and work from home, according to a statement from her office. Warnock, who did not wear a mask, was seen huddling with Vice President Kamala Harris and Sen. Cory Booker (D-N.J.) during the vote. He said that he is "so thankful to be both vaccinated and boosted." Senators Collins and Warnock join a growing list of prominent political figures who have tested positive for the coronavirus in recent weeks. (Saric, Axios, 4/7)
    • Maryland: CMS on Thursday issued a final decision to restrict coverage of Biogen's Alzheimer's drug Aduhelm to patients enrolled in randomized clinical trials. According to CMS Administrator Chiquita Brooks-LaSure, the agency's decision was intended to protect patients while additional data is gathered to determine whether the drug could benefit them. "It's our obligation at [CMS] to really make sure it's reasonable and necessary," Brooks-LaSure said. "The vast majority" of the approximately 10,000 comments the agency received on its website were in favor of "really limiting coverage of Aduhelm to a really controlled space where we could continue to evaluate its appropriateness for the Medicare population," she added. However, some experts have criticized the decision. For instance, George Vradenburg, chairman of the patient group UsAgainstAlzheimer's, said CMS' decision was "devastating" for Alzheimer's patients and that it set a precedent that could impact other drugs. "The precedent they're setting is that Medicare beneficiaries cannot have access to any drug unless it is proven in a phase 3 clinical trial to produce a clear clinical benefit," Vradenburg said. "That means every accelerated approval ... is not going to be covered until there is a demonstrated clinical benefit for those drugs." (Bernstein/Roubein, Washington Post, 4/7; Belluck, New York Times, 4/8; Foley/Wilson, Politico, 4/7; Reed, Axios, 4/8; Goldman/Devereaux, Modern Healthcare, 4/7)
    • Oregon: The state of Oregon on Thursday sued the Center for COVID Control (CCC), an Illinois-based Covid-19 testing company, and its testing partner, Doctors Clinical Laboratory (DCL), saying its owners violated the state's Unlawful Trade Practices Act when they allegedly took millions of dollars in federal funds and insurance money for personal use. In the lawsuit, the state noted that Aleya Siyaj and Akbar Ali Syed, a married couple who own CCC, did not have any prior experience in the medical field or medical testing—raising questions about how they came to be recipients of federal testing funds. The lawsuit alleges that CCC and DCL claimed they could provide accurate PCR test results within 72 hours but instead produced questionable results. In addition, the lawsuit alleges that the companies did not have adequate capacity to process and store the samples they received. "These companies were ill-equipped to scale up as fast as they did," said Oregon Attorney General Ellen Rosenblum. (AP/Modern Healthcare, 4/7)

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