Removal of prior authorization for certain mental health services signed into law
Gov. JB Pritzker signed off Tuesday on a plan that will remove prior authorization for outpatient and partial hospitalization for mental health services deemed medically necessary.
Legislative session focused on PBM reform, behavioral health coverage
Lawmakers approved sweeping changes to pharmacy benefit managers and removed prior authorization for some behavioral health services during the recently concluded spring session. Below is a roundup of some of the proposals that […]
Senate approves removal of prior authorization for certain behavioral health services
The Senate signed off Thursday evening on a plan to remove prior authorization for outpatient and partial hospitalization for behavioral health services deemed medically necessary.
New Monoclonal Authorized to Prevent COVID in Immunocompromised People
The FDA issued an emergency use authorization (EUA) for pemivibart (Pemgarda) as COVID-19 pre-exposure prophylaxis in immunocompromised individuals who are unlikely to mount a sufficient immune response following vaccination, the agency announced on Friday. A long-acting monoclonal antibody, pemivibart is specifically authorized for people ages 12 years and older (and weighing 40 kg or more) […]
Q&A: Talking Prior Authorization With Rep. Suzan DelBene
Although the Centers for Medicare & Medicaid Services (CMS) issued a final rule on prior authorization, there is more that can be done to ease clinician burdens in this area, according to Rep. Suzan DelBene (D-Wash.). DelBene sponsored the Improving Seniors’ Timely Access to Care Act, which would, among other provisions, require affected plans to […]
FDA OKs Over-the-Counter Gel for Erectile Dysfunction
The FDA has granted over-the-counter marketing authorization to MED3000 (Eroxon), the first nonprescription topical gel for treating erectile dysfunction (ED), maker Futura Medical announced on Monday. According to the company, MED3000 has “a 10-minute onset of action” that sets it apart from prescription PDE5 inhibitors such as sildenafil (Viagra) and tadalafil (Cialis), which typically require […]
Novel Drug Authorized for Critically Ill COVID-19 Patients
The FDA has issued an emergency use authorization (EUA) for vilobelimab (Gohibic) to treat critically ill adults with COVID-19. In the EUA for the first-in-class monoclonal anti-human complement factor C5a antibody, the agency specified that the therapy be initiated within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). It is given at […]
Medicare Advantage Plans Fielded 35 Million Prior Auth Requests in 2021
Over 35 million prior authorization requests were submitted to Medicare Advantage insurers in 2021, according to a new report from the Kaiser Family Foundation (KFF). Two million of these requests, or 6%, were fully or partly denied, according to Jeannie Fuglesten Biniek, PhD, associate director of the Program on Medicare Policy, and Nolan Sroczynski, MSPH, […]
Evusheld No Longer Authorized for COVID Prevention
Tixagevimab-cilgavimab (Evusheld) lost authorization for use in the U.S. to prevent COVID-19 until further notice, the FDA announced on Thursday. The agency revised the monoclonal antibody cocktail’s emergency use authorization (EUA) to limit its use to only periods when SARS-CoV-2 variants susceptible to it account for at least 9% of COVID-19 cases nationally. “Data show […]
Long-Denied COVID Vax Lands Authorization
As expected, the FDA has granted an emergency use authorization (EUA) for Novavax’s COVID-19 vaccine in adults, the agency announced on Wednesday. The decision follows a near-unanimous FDA advisory committee recommendation more than a month ago, with the EUA reportedly delayed in order to allow regulators time to review recent changes to the vaccine’s manufacturing […]