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Breaking MA News

RADV Rule Sets MA Overpayment Recoup Strategy, Nixes FFS Adjuster

CMS on Monday (Jan. 30) announced it will extrapolate Medicare Advantage audit data beginning with payment year 2018 as it moves to claw back overpayments with its long-awaited Medicare Advantage Risk Adjustment Data Validation (RADV) rule.

Latest Pandemic News

NIH Advisers: Hike Controls On Pandemic-Potential Pathogen Research

The National Security Advisory Board for Biosecurity (NSABB) voted Friday (Jan. 27) to recommend the government tighten its oversight of experimentation involving pandemic-potential pathogens (PPPs), addressing a topic that has become hotly debated due to the COVID-19 pandemic and political controversy about its origins.

FDA Panel Backs Using Bivalent Formula For Primary, Booster COVID Shots

FDA Pulls Evusheld EUA; Former Adviser Urges EUA For Veru’s Drug

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Latest News

More individuals would be able to access contraceptive services despite receiving insurance coverage from an entity with a religious objection to providing them, if a rule the Biden administration proposed Monday (Jan. 30 goes into effect.

The Environmental Defense Fund (EDF) is planning to file a food additive petition to the Food and Drug Administration (FDA) asking that it revoke its decades-old approval of fluorine-treated polyethylene for food packaging, a move that would increase pressure on the agency to ban PFAS in products that contact food.

Senate Finance Committee Chair Ron Wyden (D-OR) told attendees at a Families USA conference Thursday (Jan. 26) that mental health care reforms, workforce support and crackdowns on the pharmaceutical industry and pharmacy benefit managers are still high on his agenda for the new year. Bipartisan policies for the new year could include telehealth, rural health care and transparency issues, Wyden said.

The Medicaid and CHIP Payment and Access Commission (MACPAC) on Friday (Jan. 27) voted to recommend Congress grant states the ability to impose Medicaid coverage limitations on drugs approved by FDA that lack full evidence of efficacy and for which CMS restricts Medicare coverage as more evidence is gathered on whether the drugs work.

A group of FDA advisers will meet March 20 to discuss Harm Reduction Therapeutics’ proposed over-the-counter naloxone nasal spray, which was granted priority review by the agency in December, coming as the Biden administration pushes to increase access to and affordability of the overdose reversal drug as part of its broader strategy to address the opioid overdose epidemic.

FDA on Friday (Jan. 27) published draft guidance that proposes eliminating the 3-month deferral on blood donations for men who have sex with men in an attempt to move toward a gender-inclusive, individual risk-based approach to assessing blood donor eligibility, after years of calls from some lawmakers, LGBTQ advocates, and medical and policy experts who argued the agency’s deferral policy is discriminatory against gay and bisexual men.

CMS and California on Thursday (Jan. 26) announced that, for the first time, Medicaid will pay for a limited set of health services for 90 days before those who are incarcerated go back to their community, including substance use treatment and behavioral health services, and help connect them to community-based Medicaid providers.

The number of Medicare Advantage plans offering Special Supplemental Benefits for the Chronically Ill and Expanded Primarily Health-Related Benefits continued to rise meteorically for the 2023 year, according to new insights from ATI Advisory, but with MA oversight in CMS’ crosshairs and stakeholders anxiously awaiting the final version of a 2018 risk adjustment rule that cleared the White House Thursday (Jan. 26), the announcement comes at a moment strained by potential upheaval.

FDA is calling for Congress to set up a new regulatory pathway for cannabidiol (CBD) products after concluding the current framework for foods and dietary supplements won’t work for CBD, nor is it appropriate for animal food.