Billy Wynne

Agency Finalizes DTC TV and Radio Advertisement Requirements for Prescription Drugs  The Food and Drug Administration (FDA) issued a final rule to amend its regulations regarding direct-to-consumer (DTC) advertisements for prescription drugs presented in television or radio format to ensure that the major statement relating to side effects and contraindications are be presented in a…

Manufacturer Discount Program Final Guidance Released; Make Clarifications Regarding Specified Manufacturer Phase-In, Applicable Discounts, and Conditions for Coverage The Centers for Medicare and Medicaid Services (CMS) released the Medicare Part D Manufacturer Program final guidance, pursuant to the Inflation Reduction Act, that becomes effective beginning January 1, 2025. CMS also released the Manufacturer Discount Program…

Administration Unveils Social Determinants of Health Resources; Includes Playbook and Call to Action to Improve Health and Well Being The Biden-Harris Administration, in collaboration with the Department of Health and Human Services (HHS), released several resources aimed at improving health and well-being by addressing social determinants of health (SDOH). HHS acknowledged the significant impact of…

Department Seeks Nominations for Advisory Committee Addressing Long COVID Impacts; Nominations Due January 16 The Department of Health and Human Services (HHS) announced the establishment of the  Secretary’s Advisory Committee on Long COVID to advise on research and innovation in the comprehensive government response to the lasting effects of COVID-19 and invites nominations for the…

Innovation Center Announces NOFO Application Period for AHEAD Model; LOIs for Cohorts 1 & 2 Due by Feb. 5 Today, the Center for Medicare & Medicaid Innovation (CMMI/Innovation Center) released a notice of funding opportunity (NOFO) for the AHEAD Model (IHPP summary). The Innovation Center also hosted a webinar to discuss the new model, which…

Department Unveils Comprehensive Language Access Plan for Inclusive Health Care The Department of Health and Human Services (HHS) unveiled a comprehensive Language Access Plan aimed at enhancing access to health care and services for individuals with Limited English Proficiency (LEP) and disabilities. This initiative aligns with President Biden’s executive orders promoting equity and inclusion across…

HHS Notice of Benefit and Payment Parameters for 2025 proposed rule The Centers for Medicare and Medicaid Services (CMS) released the HHS Notice of Benefit and Payment Parameters for 2025 proposed rule (fact sheet) – a wide-ranging rule affecting Marketplaces and qualified health plans in the individual and small group markets, as well as requirements…

Agency Announces $52 Million for Fruit and Vegetable Incentive Programs The Department of Agriculture (USDA) announced an investment of more than $52 million to improve dietary health and access to fresh fruits and vegetables through the Gus Schumacher Nutrition Incentive Program (GusNIP). GusNIP funds various projects that work with other USDA nutrition programs like the…

Task Force Concludes More Research is Needed to Recommend For or Against Screening and Interventions for Oral Health in Asymptomatic Adults and Children 5 Years and Older The US Preventive Services Task Force (USPSTF) released two final recommendation statements concluding that evidence is insufficient to assess the balance of benefits and harms of routine screening…

Subcommittee Explores Guardrails for AI in Health Care that Balance Innovation, Biosecurity, and Patient Safety The Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security convened a hearing to examine the potential benefits and risks of integrating artificial intelligence (AI) into the health care sector. This marks the first Senate…