Billy Wynne

Agency to Provide Broader Coverage of Traditionally Approved Drugs to Slow the Progression of Alzheimer’s Disease Today, the Centers for Medicare and Medicaid Services (CMS) announced that if the Food and Drug Administration (FDA) grants traditional approval to Leqembi, the agency would provide broader Medicare coverage on the same day of approval. The announcement further…

COVID-19 Vaccination HCP Requirement for Medicaid, Medicare Providers Ended The Centers for Medicare and Medicaid Services (CMS) issued a final rule that makes regulatory changes to COVID-19 vaccination and testing requirements as part of the agency’s transition out of the COVID-19 public health emergency (PHE), which ended on May 11, 2023. What it is. During…

Proposed Rule Issued to Require Patient Medication Information in Labeling; Comments are Due Nov. 27 The Food and Drug Administration (FDA) issued a proposed rule to amend its prescription drug labeling regulations to require the inclusion a new Medication Guide, referred to as Patient Medication Information (PMI) (press release). The FDA details that PMI would…

Department Awards Funding to Strengthen the 988 Lifeline and Mobile Crisis Response Teams The Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), awarded $9.3 million in grants to 13 communities to establish or enhance mobile crisis response teams. These teams will provide assistance during mental health…

Committee Advances Six Bills to Lower Health Care Costs and Increase Price Transparency; PATIENT Act Advanced with Site-Neutral Payments for Outpatient Drugs, PBM Reform and Reauthorization for Health Workforce Programs The House Energy & Commerce (E&C) Health Subcommittee convened a markup of bipartisan bills focused on lowering health care costs, strengthening Pharmacy Benefit Managers (PBMs)…

Agency Solicits Input and Expertise to Inform Measure Development for Medicaid HCBS and Medicare QPP The Centers for Medicare & Medicaid Services (CMS) recently opened a public comment opportunity related to Medicaid home and community based services (HCBS) quality measure development, maintenance, and alignment. Details about the opportunity follow in the table below.   Measure…

Agency Proposes Medicaid Drug Rebate Program Transparency Requirements Including Drug Price Verification Survey The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to implement new policies in the Medicaid Drug Rebate Program (MDRP) to increase transparency. What is it. The proposed rule establishes new requirements under the MDRP, including requirements for manufacturers,…

FAQs Explain What the End of the PHE Means For Coverage of COVID-19 Vaccines and Tests, and Flexibilities Related to Telehealth and Billing The Centers for Medicare and Medicaid Services (CMS) released a set of frequently asked questions (FAQs) on waivers, flexibilities, and the end of the COVID-19 public health emergency (PHE) that expired May…

New Actions Aimed Youth Mental Health and Online Safety Released The Biden Administration released a fact sheet on actions to protect youth mental health, safety, and privacy online. The White House asserts that social media use in schools is affecting students’ mental health and disrupting learning tackling the mental health crisis is a top priority…

Maternal Health Updates: HRSA Awards $65+ Million to Health Centers to Improve Maternal Health; HHS Announces Newborn Supply Kits and Website for New Families The Department of Health and Human Services (HHS) recently announced $65 million in grants to help health centers address the maternal health crisis plus a partnership with Baby2Baby to support families…