News & Analysis as of

Regulatory Requirements Inflation Reduction Act (IRA)

Bracewell LLP

Sustainable Aviation Fuel: An Overview of the Current Regulatory Landscape in the UK, EU And USA

Bracewell LLP on

We have set out below an overview of the current regulatory frameworks governing Sustainable Aviation Fuel (SAF) in the key jurisdictions of the UK, EU and USA. SAF has emerged as a critical component in the global drive...more

Hogan Lovells

House advances 'One Big Beautiful Bill': Implications of new FEOC restrictions on clean energy tax credits

Hogan Lovells on

On May 12, 2025, the House Ways and Means Committee reported out a significant tax reconciliation bill, known as the “One, Big, Beautiful Bill.” While the bill aims to extend and enhance several provisions from the 2017 Tax...more

Husch Blackwell LLP

Updates on Executive and Legislative Developments Impacting Renewable Energy

Husch Blackwell LLP on

Executive and legislative actions impacting renewable energy at the federal, state, and local levels have arisen at an unprecedented rate since President Donald Trump took office. In January, we outlined in this legal update...more

Groom Law Group, Chartered

CMS Finalizes Annual Medicare Advantage and Part D Rulemaking Updates

In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Advantage plans and Medicare Part D prescription drug coverage, including the Final CY 2026 Part D...more

Groom Law Group, Chartered

CMS Finalizes Updates to the Prescription Creditable Coverage Methodology Determination

In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Part D prescription drug coverage, including the Final CY 2026 Part D Redesign Program Instructions....more

Epstein Becker & Green

CMS Issues CY 2026 MA & Part D Rate Announcement, Final Rule on CY 2026 Policy and Technical Changes to Programs, While Seeking...

Epstein Becker & Green on

Several April releases seem to signal some basis for optimism for stakeholders in Medicare Advantage and Part D, though with sufficient undertones to recommend caution....more

Holland & Knight LLP

CMS Final Rule on CY 2026: Policy and Technical Changes

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

McDermott+

An MA Extravaganza: Overview of the Final Rule and Rate Announcement

McDermott+ on

This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more

Cozen O'Connor

Democratic AGs Sue Over Access to Clean-Energy Funds

Cozen O'Connor on

A group of four Democratic AGs sued the EPA and Citibank, N.A., as a financial agent for the federal government, alleging that they wrongfully denied the states access to funds appropriated by Congress for clean-energy...more

Mintz - Health Care Viewpoints

CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more

Ankura

Bona Fide Service Fees, Government Price Reporting, and the Inflation Reduction Act

Ankura on

“Manufacturers are responsible for meeting all four parts of the definition of bona fide service fee before a fee can qualify as a bona fide service fee.” ...more

Orrick, Herrington & Sutcliffe LLP

Final Regulations Released for the Clean Electricity Low-Income Communities Bonus Credit Program

The U.S. Department of the Treasury and the Internal Revenue Service have published final regulations concerning the low-income communities bonus credit program under Section 48E(h) of the Internal Revenue Code of 1986, as...more

Orrick, Herrington & Sutcliffe LLP

New IRS Guidance on Domestic Content Bonus Credit

The U.S. Department of the Treasury and the Internal Revenue Service have issued Notice 2025-08 (the “First Updated Elective Safe Harbor”), offering new guidance on the bonus credit for projects using domestically produced...more

Mayer Brown

Treasury Issues Final Regulations on Technology Neutral Clean Energy Projects

Mayer Brown on

On January 7, 2025, the US Department of the Treasury (“Treasury”) and the Internal Revenue Service (“IRS”) issued final regulations (the “Final Regulations”) relating to technology-neutral tax credits for clean energy...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Fourth Edition: Q1 2025

Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022...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

Mintz

Mintz IRA Update — Operationalizing the Medicare Prescription Payment Plan and Medicare Inflation Rebate Program

Mintz on

In addition to the Part D Benefit Redesign, the IRA’s Medicare Prescription Payment Plan (MPPP) went into effect beginning January 1, 2025. The MPPP requires Part D Sponsors (PDPs) to allow Part D beneficiaries to pay for...more

Morgan Lewis

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Morgan Lewis on

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

Pillsbury Winthrop Shaw Pittman LLP

Federal Funding in Flux: Policy Shifts and Uncertain Terrain

Executive orders, funding freezes, and what’s next for federal disbursements - In his first week in office, President Trump issued a record number of executive orders (EOs) and key executive memorandums, setting new federal...more

Holland & Knight LLP

Key Highlights of the Section 761 Final Regulations and Impact on Section 6417 Direct Payments

Holland & Knight LLP on

Under Section 6417 of the Code, as enacted by the Inflation Reduction Act (IRA), certain taxpayers that fall within the statutory definition of "applicable entities" are allowed to elect to receive a direct payment (i.e.,...more

Akin Gump Strauss Hauer & Feld LLP

FERC Increases Maximum Civil Monetary Penalties for 2025

On January 6, 2025, the Federal Energy Regulatory Commission (FERC) issued a Final Rule to amend its regulations governing the maximum civil monetary penalties assessable for violations of statutes, rules and orders within...more

Ropes & Gray LLP

Adapting to the IRA: Early Lessons Learned on the IRA’s Impact on Deal-Making, Drug Economics, and Business Strategy

Ropes & Gray LLP on

More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more

IR Global

ESG Litigation is Increasing – 3 Tips to Navigate Disputes

IR Global on

The greentech industry is recognized as one of the key subsectors of the ESG investment world. Energy transition to renewables is the new industrial revolution. It is a global win-win-win for bolstered economic strength,...more

Mayer Brown

Final Regulations on Taxpayers Eligible for Direct Pay Electing Out of Subchapter K

Mayer Brown on

On November 20, 2024, the US Department of the Treasury and the Internal Revenue Service (“IRS”) issued final regulations (the “Final Regulations”) to allow certain unincorporated organizations owned by specified “applicable...more

Steptoe & Johnson PLLC

Biden Administration Finalizes Waste Emission Charge Rule

Steptoe & Johnson PLLC on

On November 12, 2024, less than one week after the most recent presidential election which will likely result in substantial changes to energy policy in the United States, the United States Environmental Protection Agency...more

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