News & Analysis as of

Manufacturers Reporting Requirements

Paul Hastings LLP

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

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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

Holland & Knight LLP

PFAS in Cosmetics: State-Led Regulatory Surge Demands Proactive Compliance

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States are rapidly enacting and implementing bans and reporting requirements for per- and polyfluoroalkyl substances (PFAS) in cosmetics, creating a complex and evolving compliance environment for manufacturers, distributors,...more

Bergeson & Campbell, P.C.

EPA Issues Final SNUR for Graphene Nanoplatelets (Generic)

On July 29, 2025, the U.S. Environmental Protection Agency (EPA) issued final significant use rules (SNUR) for certain chemical substances, including graphene nanoplatelets (generic), that were the subject of premanufacture...more

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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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

Goodwin

340B Rebate Pilot Program Proposed by HRSA

Goodwin on

On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more

Shook, Hardy & Bacon L.L.P.

Material Concerns: Legal Updates on Substances of Emerging Concern

First effective in 2024, the Act bans the sale or distribution of various products that contain intentionally added PFAS chemicals. On January 1, 2026, as part of the product phase-out timeline, the new law bans the sale or...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...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

Blank Rome LLP

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

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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

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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

Akin Gump Strauss Hauer & Feld LLP

Update: Minnesota to Delay PFAS Reporting Deadline

Last month, the Minnesota Pollution Control Agency (MPCA) announced that it would delay the January 1, 2026, reporting deadline for manufacturers of intentionally added PFAS-containing products. Though MPCA did not provide...more

BCLP

Minnesota Delays PFAS Reporting Deadline Six Months to July 1, 2026

BCLP on

On July 23, 2025, the Minnesota Pollution Control Agency (MPCA) announced that it will allow manufacturers an additional six months to report required PFAS information, extending the original January 1, 2026, deadline to July...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

Cozen O'Connor

OSHA Renews Focus On Amputations In Manufacturing

Cozen O'Connor on

OSHA recently renewed its national emphasis program focused on preventing amputations in manufacturing, effective June 27. The national emphasis program will remain in place for five years, and programmed inspections may...more

Beveridge & Diamond PC

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

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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

Bergeson & Campbell, P.C.

Minnesota Extends January 1, 2026, PFAS Reporting Deadline to July 1, 2026

The Minnesota Pollution Control Agency (MPCA) announced on July 23, 2025, that it will extend the January 1, 2026, deadline for reporting products containing intentionally added per- and polyfluoroalkyl substances (PFAS) to...more

Conn Maciel Carey LLP

Don’t Get Caught Off Guard: OSHA Renews Its Machine Safety (Amputations) National Emphasis Program

Conn Maciel Carey LLP on

OSHA announced that it is renewing its National Emphasis Program (NEP) to Address Amputations in Manufacturing. The renewed NEP will replace the previous version which expired on June 27 and will remain in place for five...more

Eversheds Sutherland (US) LLP

Global Supply Chain Horizons - July 2025

Welcome to the latest edition of our quarterly global supply chain horizons providing you with a update on the key developments from around the world. Cross-Border - China and the US trade deal - On June 27, the PRC...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

Fox Rothschild LLP

Minnesota Extends Its PFAS-in-Products Reporting Deadline After Significant Public Comments

Fox Rothschild LLP on

After evaluating public comments on its proposed PFAS-in-products reporting rules, the Minnesota Pollution Control Agency (MPCA) has agreed to exercise its authority under section 116.943 of the Minnesota Statutes (Amara’s...more

Jackson Lewis P.C.

OSHA’s 2025 Amputations NEP: Key Changes Manufacturers Should Know

Jackson Lewis P.C. on

The Occupational Safety and Health Administration (OSHA) has issued its 2025 update to the National Emphasis Program on Amputations in Manufacturing Industries (Amputations NEP), renewing the program and introducing several...more

Kelley Drye & Warren LLP

Reminder: Federal Communications Commission – July and August Filings - 2025

Manufacturers of wireless handsets that are used in the delivery of digital commercial mobile radio service within the scope of FCC Rule 20.19 are required to file information annually regarding their compliance with the...more

Foster Garvey PC

Colorado’s EPR Law Enters First Compliance Phase: Reporting Due July 31

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Colorado’s comprehensive extended producer responsibility (EPR) program reporting deadline is fast approaching. Producers (including brand owners, manufacturers, importers and retailers) of packaging and paper products are...more

Morgan Lewis

EPA Extends PFAS Reporting Deadline Under Toxic Substances Control Act Once More

Morgan Lewis on

EPA’s May 13 interim final rule, which extended the start and end dates of the PFAS Toxic Substances Control Act Section 8(a)(7) reporting period for all manufacturers by nine months, was EPA’s second such extension to the...more

Beveridge & Diamond PC

EPA Continues Focus on Antimicrobial Pesticide Enforcement in 2025

Key Takeaways - What Happened: EPA continues to assess significant penalties against manufacturers and distributors of antimicrobial products under the new administration....more

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