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Inflation Reduction Act (IRA) Manufacturers

ArentFox Schiff

HHS Announces 340B Rebate Model Pilot Program

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On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the...more

Ropes & Gray LLP

HRSA Announces 340B Rebate Model Pilot Program

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On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more

ArentFox Schiff

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

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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

Hogan Lovells

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

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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

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

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Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more

Bergeson & Campbell, P.C.

Big Beautiful Bill Means Big Cuts for Clean Energy Manufacturers

On March 20, 2025, House Republicans passed the “Big Beautiful Bill” (BBB) as part of H.R. 1, a sweeping legislative package that includes dramatic rollbacks of many of the clean energy tax credits established under the...more

Mayer Brown

House Reconciliation Bill Amends Clean Energy Provisions of the IRA

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On May 22, 2025, the House of Representatives passed its reconciliation bill, H.R. 1, entitled “One Big Beautiful Bill Act” (the “legislation”), which significantly amends the clean energy provisions that were enacted as part...more

Frost Brown Todd

Three Tax Issues Manufacturers Should Watch in 2025 Budget Bill

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On May 13, the House Ways and Means Committee voted to approve a $3.8 trillion tax bill that would make permanent much of the 2017 Tax Cuts and Jobs Act. The bill then moved to the House Budget Committee, where it was merged...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - May 2025 #2

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Dickinson Wright

Plugged In: An EV Newsletter Vol. 3, No. 5

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Welcome to the May 2025 edition of Plugged In! As tariffs continue to dominate headlines—and create headaches—in the auto world, Mark Heusel and Hezi Wang offer a Tariff Tracker to help businesses navigate the ever-shifting...more

Hogan Lovells

CMS issues draft guidance on IRA 2028 Drug Price Negotiation Program, 2026-28 MFP Effectuation

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On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2028 of the Drug Price Negotiation Program (DPNP) established by the Inflation Reduction...more

Holland & Knight LLP

Pennsylvania DEP Accepting Applications for $320M RISE PA Program

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With a total funding of $396 million, the Reducing Industrial Sector Emissions in Pennsylvania (RISE PA) Program's goal is to significantly reduce greenhouse gas (GHG) emissions and co-pollutants from Pennsylvania's...more

Latham & Watkins LLP

Healthcare & Life Sciences Drug Pricing Digest - April 2025

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The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

DLA Piper

Industrials Regulatory News and Trends - February 2025 #2

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Welcome to Industrials Regulatory News and Trends. In this regular bulletin, DLA Piper lawyers provide concise updates on key developments in the industrials sector to help you navigate the ever-changing business, legal, and...more

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

Mintz on

The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

Bass, Berry & Sims PLC

340B Drug Rebate Models: Status and Litigation Update

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Four drug manufacturers have announced plans to offer discounted drug prices to safety net providers under the federal 340B program via rebates instead of upfront discounts, despite the federal government’s position that...more

Morgan Lewis

How the US Election May Affect Drug Pricing, Medicare, and Medicaid Programs – Key Areas to Watch

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Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more

Paul Hastings LLP

Treasury and IRS Release Final Regulations on Section 45X Advanced Manufacturing Production Credit

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The Inflation Reduction Act of 2022 added the Section 45X Advanced Manufacturing Production Credit (Section 45X) to the Internal Revenue Code of 1986, as amended. Section 45X provides a credit against federal income tax for...more

Mayer Brown

Treasury and IRS Issue Final Regulations on Section 45X

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On October 24, 2024, the US Department of Treasury (“Treasury”) and the Internal Revenue Service (“IRS”) released final regulations (the “Final Regulations”) on the Section 45X Advanced Manufacturing Production Credit of the...more

Holland & Knight LLP

Highlights of Final Regulations Under Section 45X Advanced Manufacturing Tax Credit

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The U.S. Department of the Treasury and IRS on Oct. 28, 2024, published final regulations regarding the Section 45X Advanced Manufacturing Production Credit of the Internal Revenue Code (Final Regulations)....more

Troutman Pepper Locke

IRS Issues Final Regulations on Section 45X Credits for Advanced Manufacturing Production Credit

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On October 24, the Treasury Department (Treasury) and the Internal Revenue Service (IRS) issued final regulations (Final Regulations) on the Advanced Manufacturing Production Credit (Section 45X Credit), pursuant to Section...more

Foley & Lardner LLP

IRS Releases Final Regulations for Section 45X Advanced Manufacturing Credit

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The Internal Revenue Service (“IRS”) and Department of the Treasury last week released final regulations (the “Final Regulations”) relating to the advanced manufacturing production tax credit under Section 45X (“45X Credits”)...more

Jones Day

Final Regulations Clarify Requirements for the Advanced Manufacturing Production Credit

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The Department of Treasury and the Internal Revenue Service ("IRS") issued final regulations regarding the advanced manufacturing production tax credit....more

Holland & Knight LLP

Election Implications for Clean Energy, Climate, Critical Minerals Programs at DOE

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The 2024 U.S. presidential election is shaping up to be one of the most uncertain and unpredictable in history. The future and overall success of the U.S. Department of Energy's once-in-a-generation clean energy investments...more

Hogan Lovells

CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

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On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

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