Generic Drug Work Plan Discussed; Commissioners Suggest Exploring Specialty Generics and Vertical Integration

Generic Drug Work Plan Discussed; Commissioners Suggest Exploring Specialty Generics and Vertical Integration

The Medicare Payment Advisory Commission (MedPAC) convened a session to discuss the Commission’s workplan to analyze generic drug prices in Medicare Part D. MedPAC staff detailed that the Commission is currently examining generic drug prescription drug event (PDE) data, as well as interviewing pharmaceutical supply chain stakeholders to determine factors that impact generic drugs being priced higher in Medicare than… (Slifer, October 6, 2023) #Generic Drugs, #Medicare Part D, #Prescription Drugs

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AHRQ Issues Supplemental Evidence and Data Request on Mental Health and Occupational Stress in the Emergency Medical Service and 911 Workforce

AHRQ Issues Supplemental Evidence and Data Request on Mental Health and Occupational Stress in the Emergency Medical Service and 911 Workforce

The Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers (EPC) Program issued a request for supplemental evidence and data submissions (SEADs) to inform its review on Mental Health and Occupational Stress in the Emergency Medical Service and 911 Workforce.  AHRQ commissioned the EPC Program to conduct a systematic review on occupational stress and or/mental health in the 911 and… (Marceno, October 3, 2023) #Mental and Behavioral Health, #Quality, #Workforce

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Agency Suggests That CMS Explore Policies to Reduce Prices of Biosimilars and Part B Biologics

Agency Suggests That CMS Explore Policies to Reduce Prices of Biosimilars and Part B Biologics

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report showing that biosimilar competition has led to lower costs for the Medicare Part B program and enrollees. Part B drugs are usually large, complex molecules delivered through infusions or injections in a doctor’s office. These are some of the most costly drugs and often… (McClurg, October 3, 2023) #Biosimilars

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Senate HELP Ranking Member Cassidy Seeks Stakeholder Input on NIH Reform; Due Oct. 27

Senate HELP Ranking Member Cassidy Seeks Stakeholder Input on NIH Reform; Due Oct. 27

On Friday, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-OA) announced a request for stakeholder input to inform potential reforms to the National Institutes of Health (NIH) in areas such as increasing the pace of science, organizing NIH for success, and increasing transparency and oversight. Comments are due October 27. Political Landscape. Ranking Member Cassidy opens his letter… (Lewis, October 2, 2023) #National Institutes of Health

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Agency Estimates CMMI Increased Federal Spending by $5.4 Billion From 2011 through 2020; Agency Expected to Increase Spending by $1.3 Billion from 2021 to 2030

Agency Estimates CMMI Increased Federal Spending by $5.4 Billion From 2011 through 2020; Agency Expected to Increase Spending by $1.3 Billion from 2021 to 2030

The Congressional Budget Office (CBO) released an updated estimate that indicates the Center for Medicare and Medicaid Innovation (CMMI), established under the Affordable Care Act (ACA) to explore innovative health care payment models, is expected to increase federal spending by $1.3 billion from 2021 to 2030. This follows a significant increase in spending by CMMI during its first decade, where… (Colocho, September 29, 2023) #Budget, #Costs, #Delivery Reform, #Program Integrity, #Public Health

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Agency Releases New Medicaid Information and Questions for Public Comment on Mental Health Parity, Due December 4th

Agency Releases New Medicaid Information and Questions for Public Comment on Mental Health Parity, Due December 4th

Today, the Centers for Medicare and Medicaid Services (CMS) released multiple pieces of information for states and stakeholders. The release, described in full below, includes a letter reinforcing the continuous eligibility requirement for individuals 19 and under; additional state data related to Medicaid and CHIP eligibility renewals, and questions for public comment on Medicaid and CHIP implementation of the Mental… (Marceno, September 29, 2023) #Coverage Decisions, #Mental and Behavioral Health, #Public Health

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Proposed Rule Issued to Make Explicit that Lab Developed Tests (LDTs) Are Devices Under FDA Regulation; Comments Due Dec. 2

Proposed Rule Issued to Make Explicit that Lab Developed Tests (LDTs) Are Devices Under FDA Regulation; Comments Due Dec. 2

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

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Agency Awards $42.6 Million to Support the Implementation of Evidence-based Prevention Strategies

Agency Awards $42.6 Million to Support the Implementation of Evidence-based Prevention Strategies

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

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Biden-Harris Administration Announces Sweeping Initiatives and Over $103 Million in Funding to Tackle Maternal Health Crisis on HHS Maternal Health Day of Action

Biden-Harris Administration Announces Sweeping Initiatives and Over $103 Million in Funding to Tackle Maternal Health Crisis on HHS Maternal Health Day of Action

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

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Ranking Member Cassidy Seeks Stakeholder Input on CDC Reform; Due Oct. 20

Ranking Member Cassidy Seeks Stakeholder Input on CDC Reform; Due Oct. 20

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

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