The Food and Drug Administration (FDA) issued a proposed rule to amend it regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Food, Drug, and Cosmetic (FD&C) Act, including when the manufacturer of the IVD is a laboratory (press release). What is it. Historically, the FDA has exercised enforcement discretion over laboratory developed tests (LDT),… (Slifer, September 29, 2023) #Food and Drug Administration, #Medical Devices

The Substance Abuse and Mental Health Services Administration (SAMHSA) announced $42.6 million in Strategic Prevention Framework – Partnerships for Success (SPF-PFS) grants for 17 states and 60 communities across the country. SPF-PFS grants were established to prevent substance use initiation and reduce the development of substance use problems. Funding supports prevention efforts by supporting the advancement of and delivery of… (Marceno, September 28, 2023) #Mental and Behavioral Health, #Opioids, #Prevention

As part of the Department of Health and Human Services (HHS) Maternal Health Day of Action, the Biden-Harris Administration announced a series of initiatives and funding totaling more than $103 million aimed at addressing the maternal health crisis in the United States. These actions and initiatives are part of a broader effort to address the maternal health crisis in the… (Colocho, September 27, 2023) #Health Equity, #Mental and Behavioral Health, #Pediatrics, #Prevention, #Public Health, #Rural Health, #Social Determinants of Health, #Women’s Health, #Workforce

Today, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-OA) announced a request for stakeholder input to inform reforms to the Centers for Disease Control and Prevention (CDC) in areas such as data modernization, state and local coordination, and leadership. Comments are due October 20. Political Landscape. Ranking Member Cassidy begins the request for information by… (Llamas, September 26, 2023) #Public Health

The Medicaid and CHIP Payment and Access Commission convened a session to examine how states are using medical care advisory committees (MCACs) as a strategy for beneficiary engagement in the development and implementation of Medicaid policies. Senior Analyst Audrey Nuamah provided an overview on MCACs, including beneficiary barriers to participation and detailed the Centers for Medicare and Medicaid Services (CMS)… (Colocho, September 26, 2023) #Health Equity, #Transparency

Over the last several weeks the House of Representatives has been unable to pass a Continuing Resolution (CR), much less come to an agreement with the Senate on how to keep the government in operation past September 30.  Unless Congress can manage to quickly pass a CR, there are just days left before the end of the current fiscal year,… (Lewis, September 25, 2023) #Budget

The Department of Health and Human Services (HHS) through the Agency for Healthcare Research and Quality (AHRQ) awarded $45 million in grants to existing Long COVID clinics. The funding will support these multidisciplinary clinics to broaden access to coordinated, comprehensive, and person-centered care for individuals with Long COVID, especially for underserved, vulnerable, rural, and minority communities that are disproportionately impacted by Long-COVID…. (Gravesande, Marceno, September 22, 2023) #COVID-19, #Health Equity, #Public Health

The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session on Medicaid Unwinding. Principal Analysis and Research Advisor Martha Heberlein led panelists through a discussion exploring the advancements made, barriers and challenges for states and beneficiaries, and the role of CMS oversight. Panelists: Kate McEvoy, Executive Director, National Association of Medicaid Directors Allison Orris, Senior Fellow, Center on Budget and Policy… (Marceno, September 22, 2023) #Coverage Decisions, #Health Equity, #Insurance Coverage

The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session to discuss the Centers for Medicare and Medicaid Services notice of proposed rulemaking (NPRM) on nursing facility staffing and payment transparency, establishing minimum staffing standards for long-term care facilities to ensure safe and quality care (Impact Health Policy Summary). MACPAC staff presented an overview of the proposed rule… (Colocho, September 22, 2023) #Long-Term Care, #Quality, #Skilled Nursing Facilities, #Transparency, #Workforce

The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session to discuss its work plan for examining supplemental payments to hospitals. MACPAC staff provided an overview of the issue and proposed three areas of work that it plans to advance over the next two years: (1) documenting payment methods and policy goals; (2) characterizing payment targeting; and (3)… (Testa, September 22, 2023) #Costs, #Hospitals, #Program Integrity, #Transparency