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 explains that if the FDA grants traditional approval to other drugs in the same class, those products would also be eligible… (Slifer, June 1, 2023) #Coverage Decisions, #Prescription Drugs

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 the COVID-19 PHE, CMS established various requirements to minimize the spread and impact of… (Llamas, June 1, 2023) #COVID-19

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 be a one-page document with standardized format and content intended to provide patients with clear, concise, accessible, and useful written… (Slifer, May 31, 2023) #Food and Drug Administration, #Prescription Drugs

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 and substance use crises in areas with high needs, working closely with local law enforcement. The funding is… (Colocho, May 26, 2023) #Mental and Behavioral Health, #Prevention, #Public Health

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) oversight, and bringing price transparency to patients. The following bills were advanced to the House. H.R. 1418, the Animal Drug User Fee Amendments of 2023; H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network… (Colocho, May 24, 2023) #340B, #Community Health Centers, #Costs, #Disproportionate Share Hospitals (DSH), #Drug Pricing, #Generic Drugs, #Graduate Medical Education (GME), #Hospitals, #Pharmacy Benefit Managers, #Transparency, #Workforce

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 State-Level All-Cause Emergency Department (ED) Utilization for Medicaid Beneficiaries Overview CMS requests stakeholders review several documents (State-Level All-Cause ED Utilization… (Testa, May 24, 2023) #Costs, #Physicians, #Program Integrity, #Quality

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, managed care organizations (MCOs), prepaid inpatient health plans (PIHPs), and prepaid ambulatory health plans (PAHPs). Why its important… (Slifer, May 24, 2023) #Pharmacy Benefit Managers, #Prescription Drugs

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 11, 2023. The questions touch on COVID-19 vaccines and testing, telehealth, and billing implications for Medicare, Medicaid, and private insurance. Key takeaways from the FAQs are included below:… (McClurg, May 23, 2023) #COVID-19, #Telehealth

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 for the Administration. The Biden Administration details that the following actions build upon on the… (Slifer, May 23, 2023) #Mental and Behavioral Health, #Pediatrics

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 with newborn babies. Both initiatives are aligned with the White House Blueprint for Addressing the Maternal Health Crisis and aim to improve maternal and child health across the country…. (Joyce, May 22, 2023) #Mental and Behavioral Health, #Mid-Level Practitioners, #Public Health, #Women’s Health, #Workforce