CMS finalizes policies to enhance consumer protections, promote competition, and expand access to care for Medicare Advantage (MA) and Medicare Part D; digital therapeutic Rejoyn receives FDA clearance for adults with major depressive disorder (MDD); study reveals minimal symptom reduction from nirmatrelvir–ritonavir (Paxlovid) in high-risk, fully vaccinated patients.
CMS Strengthens Protections, Access for MA, Part D Enrollees
CMS announced the finalization of policies that aim to increase enrollee protections and enhance access to care in Medicare Advantage (MA) and Medicare Part D prescription drug plans, according to a press release. Key measures include restrictions on insurance agent compensation, prohibition of personal beneficiary data sharing, and requirements for health equity analysis and behavioral health provider inclusion. Additionally, the rule mandates evidence-based supplemental benefits, promotes biosimilar substitution, and prioritizes access to accurate information for Medicare enrollees.
FDA Approves First Prescription Digital Treatment for Adults With MDD
The FDA has authorized the use of Rejoyn, the first prescription digital treatment for adults with major depressive disorder (MDD), according to CNN. Developed by Otsuka Pharmaceutical and Click Therapeutics, Rejoyn utilizes a 6-week program incorporating cognitive-emotional training and cognitive behavioral therapy lessons, designed to complement existing antidepressant medications. While the app's effectiveness was not significantly different from a sham app in clinical trials, it aims to serve as an adjunct therapy for partial responders to antidepressants.
Limited Efficacy of Paxlovid in Fully Vaccinated Individuals
A recent study showed nirmatrelvir–ritonavir (Paxlovid) showed little efficacy in reducing symptoms among fully vaccinated individuals with COVID-19 risk factors, according to CIDRAP. In the trial, which included 1296 participants, there was no significant difference in symptom duration between those who received Paxlovid and those who received a placebo. Experts cautioned that the study's findings may not apply to older patients, and further research is needed to evaluate the drug's long-term effectiveness and its potential to prevent long COVID.
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