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Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

Paul Hastings LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

Husch Blackwell LLP on

On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Mintz - Health Care Viewpoints

CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

Bergeson & Campbell, P.C.

Comments on Maine’s Proposed CUU Amendment Due September 2, 2025

The Maine Department of Environmental Protection (MDEP) began a public consultation on July 30, 2025, on a proposed amendment to Chapter 90: Products Containing Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS). The...more

Blank Rome LLP

CMS Proposes New Rules for Calculating Average Sales Price for Medicare Part B Drug Reimbursement

Blank Rome LLP on

The Centers for Medicare & Medicaid Services (“CMS”) released the Calendar Year 2026 Medicare Physician Fee Schedule (“PFS”) proposed rule on July 16, 2025. (See...more

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

Ropes & Gray LLP on

The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

ArentFox Schiff on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

Beveridge & Diamond PC

Deadline Extended for Reporting PFAS in Products in Minnesota, Proposed Minnesota PFAS Reporting Rule under Administrative Review

Beveridge & Diamond PC on

Under Minnesota’s PFAS in products law, manufacturers of products containing intentionally added per- and polyfluoroalkyl substances (PFAS) must report those products to the Minnesota Pollution Control Agency (MPCA) by...more

McDermott Will & Schulte

Bye-bye, bright dyes: Strategies for responding to FDA’s synthetic food dye phase-out

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase out petroleum-based synthetic dyes from the US food supply by the end of 2026,...more

Holland & Knight LLP

Out with the Old: FDA to Revoke 52 Standards of Identity – What Food Companies Need to Know

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) announced a final rule on July 16, 2025, revoking 52 standards of identity (SOIs) for food products that it deems obsolete. The FDA currently maintains more than 250 SOIs, and this...more

Beveridge & Diamond PC

Coalition of US States and Cities Lays Groundwork for Legal Challenge of the Department of Energy’s Appliance Efficiency Rollback

Beveridge & Diamond PC on

A multistate coalition of twelve state Attorneys General—California, Connecticut, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Vermont, and Washington—joined by the District of...more

Morrison & Foerster LLP

FDA Targets 52 “Obsolete” Food Standards of Identity for Revocation

On July 17, 2025, FDA announced several rulemakings aimed at modernizing its standards of identity (SOIs) for food products – regulations that define what a food must contain and how it must be made to lawfully bear a...more

Hogan Lovells

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

Hogan Lovells on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

Womble Bond Dickinson

An Increasing Regulatory Maze for Nontraditional Meat Products

Womble Bond Dickinson on

As this blog has previously covered, various states have passed laws prohibiting plant-based products from being labeled like traditional meat products. A recent Oklahoma law bans using terms like beef, chicken, or bacon to...more

DLA Piper

Microplastics Proposed for Candidate Chemical Listing in California: Key Considerations for Businesses

DLA Piper on

California’s Department of Toxic Substances Control (DTSC) proposed adding microplastics as a Candidate Chemical to be regulated under the Safer Consumer Products (SCP) program on June 20, 2025. This action and its subsequent...more

Beveridge & Diamond PC

California Proposes Listing Microplastics Under Safer Consumer Products Program

The California Department of Toxic Substances Control (DTSC) has taken a step toward regulating microplastics. On June 20, 2025, DTSC proposed to add microplastics to its Candidate Chemical List (CCL) under the state’s Safer...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Robinson+Cole Manufacturing Law Blog

What is the Status of Affirmative Action Plans and Certification in 2025?

Manufacturers that are covered federal contractors may be wondering when they are required to certify compliance with the affirmative action plan regulations. At this point, the answer is not clear and recent proposals from...more

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

Hogan Lovells on

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Bergeson & Campbell, P.C.

WDOE Proposes to Regulate PFAS in Certain Consumer Products

The Washington Department of Ecology (WDOE) issued a proposed rule on June 4, 2025, that would regulate per- and polyfluoroalkyl substances (PFAS) in certain consumer products. Beginning January 1, 2027, the proposed rule...more

Fox Rothschild LLP

Minnesota Will Continue to Receive Public Comments on Proposed New Rules on PFAS in Products Reporting

Fox Rothschild LLP on

Minnesota’s Pollution Control Agency (MPCA) held a public hearing on May 22, 2025 concerning its proposed rules that would implement PFAS-in-products reporting requirements and associated fees on entities covered by Amara’s...more

Cozen O'Connor

Democratic AGs Take Aim at ATF’s Decision to Distribute Firearm Triggers

Cozen O'Connor on

A group of 16 Democratic AGs filed a lawsuit in federal court challenging the decision by the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to redistribute thousands of Forced Reset Triggers (FRTs) throughout the...more

Mitchell, Williams, Selig, Gates & Woodyard,...

2026 NPDES Multi-Sector General Permit for Stormwater Discharges: Steel Manufacturers Association Comments on Proposed Federal...

The Steel Manufacturers Association (“SMA”) submitted May 19th comments to the United States Environmental Protection Agency (“EPA”) addressing: Proposed 2026 Multi-Sector General Permit for Stormwater Discharges...more

Kelley Drye & Warren LLP

Reminder: Federal Communications Commission – June and July Filings

Carriers and providers of interstate and international telecommunications that seek to revise their May 1, 2025, Form 499-Q filing must do so within 45 days of the Form 499-Q filing deadline, i.e., by June 16, 2025 (because...more

Bergeson & Campbell, P.C.

Chemical Product Law and Supply: A Guide to New TSCA

Hello, this is Lynn Bergeson. As many of our listeners may know, we here at Bergeson & Campbell, P.C. recently published a book through the American Bar Association’s Section of Environment, Energy, and Resources, titled...more

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