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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

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

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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

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

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

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.

Minnesota Extends Public Comment Period on Proposed PFAS Reporting Rule as Entities Voice Concerns about Compliance with Deadlines...

On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim...more

Environmental General Counsel PC

CalRecycle Releases New EPR Packaging Regulations: Imminent Compliance, New Exclusions, and Deferred Eco-Modulation Implementation

A lot is going on in the extended producer responsibility (“EPR”) packaging world this month.  Maryland and Washington became the sixth and seventh states respectively to enact EPR packaging laws.  And this week, just a...more

Troutman Pepper Locke

PFAS Regulatory Landscape Update — The Message? Stay Tuned.

Troutman Pepper Locke on

The Environmental Protection Agency (EPA) has announced several actions in recent weeks that shed light on the Trump administration’s approach to PFAS regulation....more

Akin Gump Strauss Hauer & Feld LLP

TSCA PFAS Reporting Deadline Extended

On May 12, 2025, the U.S. Environmental Protection Agency (EPA) issued an interim final rule to amend the reporting period under the per- and polyfluoroalkyl substances (PFAS) reporting rules issued in October 2023 under the...more

Beveridge & Diamond PC

PFAS Reporting Rule Deadlines Extended – and More Changes to Come

Beveridge & Diamond PC on

The U.S. Environmental Protection Agency (EPA) published an interim final rule on May 13, 2025, extending the reporting deadlines for its Per- and polyfluoroalkyl substances (PFAS) Reporting Rule, 40 C.F.R. Part 705, which...more

Vorys, Sater, Seymour and Pease LLP

US EPA Delays TSCA PFAS Reporting and Hints at Revisions

US EPA again revised the reporting deadlines for manufacturers and importers of PFAS under the Toxic Substances Control Act (TSCA) Section 8(a)(7) rule. Like the prior extension, US EPA states that it needs additional time to...more

Faegre Drinker Biddle & Reath LLP

Comment Period Open for Massive New PFAS Reporting Requirements in Minnesota

On April 21, 2025, the Minnesota Pollution Control Agency (MPCA) issued the proposed PFAS in Products: Reporting and Fees Rule for public consultation. The proposed rule details how the MPCA will require manufacturers to...more

Kelley Drye & Warren LLP

Minnesota Proposes Rules for Reporting PFAS-Containing Products by January 2026

On April 21, 2025, the Minnesota Pollution Control Agency (“MPCA” or ​“the Agency”) released proposed rules that if finalized would help effectuate the Gopher State’s ban on per- and polyfluoroalkyl substances (“PFAS”) in...more

Beveridge & Diamond PC

Minnesota Pollution Control Agency Releases Proposed Reporting Rule for PFAS in Products

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The Minnesota Pollution Control Agency (MPCA) is seeking comment on a first-of-its-kind proposed rule that will require manufacturers of products containing intentionally added per- and polyfluoroalkyl substances (PFAS) to...more

Bergeson & Campbell, P.C.

Comments on Minnesota’s Proposed Rule for Reporting Products Containing Intentionally Added PFAS Are Due May 21, 2025

With the January 1, 2026, reporting deadline fast approaching for reporting on products containing intentionally added per- and polyfluoroalkyl substances (PFAS), on April 21, 2025, the Minnesota Pollution Control Agency...more

Burr & Forman

ADEM Proposes Revisions to its Recycling Rules – 15 Years in the Making

Burr & Forman on

After 15 years without significant revisions, the Alabama Department of Environmental Management (ADEM) is proposing an overhaul of its recycling rules.  The proposed regulations, which ADEM released for public notice and...more

Bergeson & Campbell, P.C.

States Take Action to Regulate and Limit PFAS in Industrial Effluent Despite Federal Inaction

On January 21, 2025, the U.S. Environmental Protection Agency’s (EPA) proposed rule seeking to set effluent limitation guidelines for certain per- and polyfluoroalkyl substances (PFAS) under the Clean Water Act (CWA) was...more

J.S. Held

PFAS Monitoring Requirements and Stormwater Pollution Prevention Under the 2026 NPDES Permit

J.S. Held on

On December 13, 2024, the United States Environmental Protection Agency (EPA) published a request for public comment for the 2026 National Pollutant Discharge Elimination System (NPDES) general permit for stormwater...more

Bradley Arant Boult Cummings LLP

Balancing Act: Industry Concerns Over CISA’s Proposed Cyber Incident Reporting Rule

As discussed in our previous blog post, the Cybersecurity and Infrastructure Security Agency (CISA) is proposing a significant new rule to bolster the nation’s cyber defenses through mandatory incident reporting. While...more

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