Most-Favored-Nation Pricing Targets Released; MFN Rulemaking to Occur if Commitments are not Made

Most-Favored-Nation Pricing Targets Released; MFN Rulemaking to Occur if Commitments are not Made

Pursuant to President Trump’s Executive Order (EO) on Delivering Most-Favored-Nation (MFN) Prescription Drug Pricing to American Patients, the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) announced that the agencies have identified specific MFN targets pharmaceutical manufacturers are expected to meet to satisfy the requirements of the Executive Order.  Basis for MFN… (Slifer, May 20, 2025) #Drug Pricing, #Prescription Drugs

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FDA RFI on Infant Formula Nutrient Review

FDA RFI on Infant Formula Nutrient Review

The Food and Drug Administration (FDA) issued a request for information (RFI) to begin its process of reviewing nutrition requirements in infant formulas. FDA regularly reviews individual nutrient requirements but has not undertaken a comprehensive review of the minimum and maximum levels for certain nutrients since 1998. FDA now seeks public input to help determine whether existing requirements should be revised or adjusted…. (McClurg, May 16, 2025) #Nutrition, #Pediatrics

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Committee Fails to Advance Reconciliation Bill 

Committee Fails to Advance Reconciliation Bill 

The House Budget Committee convened a markup of the combined legislative package of the eleven House Committees pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2025, H. Con. Res. 14.  The bill was not advanced by a roll call vote of 16 ayes and 21 nos. Republican members that voted against the bill included… (Slifer, May 16, 2025) #Budget, #Insurance Coverage, #Nutrition, #Program Integrity

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GAO Highlights Barriers Facing Caregiving Youth, Calls for Clearer Federal Guidance

GAO Highlights Barriers Facing Caregiving Youth, Calls for Clearer Federal Guidance

The Government Accountability Office (GAO) has released a report highlighting a lack of clarity and support for minors who provide unpaid care to family members with health conditions, disabilities, or functional limitations. According to the report, an estimated three to five million children may act as caregivers, yet they remain largely unrecognized in national caregiving policies and programs. The report… (Eisen, May 15, 2025) #Care Coordination, #Chronic Diseases, #Health Equity

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RFK Jr. Defends HHS Reorganization and Deflects Questions on Vaccines, Reductions in Staff, and Funding Cuts in House and Senate Committee Hearings

RFK Jr. Defends HHS Reorganization and Deflects Questions on Vaccines, Reductions in Staff, and Funding Cuts in House and Senate Committee Hearings

The House Appropriations Committee and the Senate Health, Education, Labor, & Pensions Committee held hearings to review the Fiscal Year (FY) 2026 budget for the Department of Health and Human Services (HHS) with Secretary Robert F. Kennedy Jr. During the sessions, both Democratic and Republican members expressed concerns about funding freezes for research programs and significant staffing cuts. While several… (Eisen, May 14, 2025) #340B, #Budget, #Insurance Coverage, #Medicare Advantage, #Mental and Behavioral Health, #National Institutes of Health, #Public Health, #Women’s Health

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CMS Issues RFI on Building a More Patient-Centered Digital Health Ecosystem

CMS Issues RFI on Building a More Patient-Centered Digital Health Ecosystem

Today, the Centers for Medicare & Medicaid Services (CMS), in partnership with the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), issued a request for information (RFI) (press release) seeking input to shape future policies and infrastructure to support digital health innovation. The RFI aims to inform strategies that expand Medicare beneficiaries’ access to… (Testa, May 13, 2025) #Health Information Technology

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House Agriculture Committee Releases Reconciliation Text; Expands SNAP Work Requirements and Requires States to Fund A Portion of Benefits

House Agriculture Committee Releases Reconciliation Text; Expands SNAP Work Requirements and Requires States to Fund A Portion of Benefits

The House Agriculture Committee released a committee print of its budget reconciliation legislation ahead of the full committee markup beginning Tuesday evening (section-by-section; overview; one-pager on state accountability; one-pager on prioritizing work in SNAP). Subtitle A deals with nutrition programs, in particular the Supplemental Nutrition Assistance Program (SNAP). This plan meets the $230 billion that the Committee was instructed to save, mostly by requiring states… (McClurg, May 13, 2025) #Nutrition

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Agencies Seek Public Input for Deregulatory Plan Aimed at Reducing Costs and Empowering Providers; Comments Due Approximately on July 12

Agencies Seek Public Input for Deregulatory Plan Aimed at Reducing Costs and Empowering Providers; Comments Due Approximately on July 12

The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a Request for Information (RFI) as part of a major initiative to reduce regulatory burdens across the health care system. This initiative implements President Trump’s Executive Orders (EOs) on deregulation, signaling a coordinated, government-wide initiative aimed at rolling back regulations deemed unlawful, burdensome, or… (Colocho, May 13, 2025) #Costs, #Physicians, #Prevention, #Primary Care, #Public Health, #Transparency, #Wellness

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Updated Budget Reconciliation Text: Health Reimbursement Arrangements, Health Savings Accounts, Premium Tax Credit Recapture Limit, and More

Updated Budget Reconciliation Text: Health Reimbursement Arrangements, Health Savings Accounts, Premium Tax Credit Recapture Limit, and More

The House Ways and Means Committee (W&M) released an amendment in the nature of a substitute (AINS) to its budget reconciliation legislation ahead of the full committee markup on Tuesday, May 13.   Health-Related Proposals. The 389-page AINS adds numerous provisions that were not included in the 28-page draft released on Friday, May 9. Major proposals include: Commercial Insurance Expand… (Llamas, May 12, 2025) #Health Insurance Exchanges, #Insurance Reform

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President Trump Signs EO on Most-Favored-Nation Pricing; HHS to Communicate MFN Price Targets by June 11

President Trump Signs EO on Most-Favored-Nation Pricing; HHS to Communicate MFN Price Targets by June 11

President Trump signed an executive order entitled “Delivering Most-Favored-Nation (MFN) Nation Prescription Drug Pricing to American Patients” (fact sheet). Overall, the EO calls out the American subsidization of prescription drugs through research and development and higher prices compared to other developed countries and attempt to end “global freeloading” and establish MFN pricing for the United States. The EO comes amid… (Slifer, May 12, 2025) #Pharmacy Benefit Managers, #Prescription Drugs

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