News & Analysis as of

Reimbursements Pharmaceutical Industry

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - October 6th - 9th, San Antonio, TX

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2025 #3

News Briefs - Physician Productivity Rising, But Reimbursement Isn't -Physicians are working more than ever, but reimbursement isn't rising in tandem. It's a worrying mismatch that could translate into access problems for...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - September 8th - 11th, Scottsdale, AZ

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

McDermott Will & Schulte

HRSA issues 340B rebate model pilot program guidance, requests comments

The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate...more

Hogan Lovells

Market Access in Europe: Navigating Pricing & Reimbursement Pathways

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In Europe, the regulation of pricing and reimbursement for medicinal products is primarily governed by national policies, as EU-level regulation is limited. Our latest brochure “Market Access in Europe: Navigating Pricing &...more

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

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

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

Blank Rome LLP

Impact of Recent CMS Rule on Site Neutrality and 340B Programs—Implications for Oncology Services

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Overview - The Centers for Medicare & Medicaid Services (“CMS”) has finalized and proposed several significant changes affecting both site neutrality in Medicare payments and the 340B Drug Pricing Program. These changes...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

Marshall Dennehey

Commonwealth Court Rejects Insurer’s Reimbursement Claim Against Pharmacy in Billing Dispute

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Pioneer Construction Company, Inc., Eastern Alliance Insurance Company, and employers Alliance, Inc. v. Insight Pharmaceuticals, LLC d/b/a Insight Pharmacy; No. 867 C.D. 2022; filed May 12, 2025; Judge Covey - A workers’...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

McDermott Will & Schulte

Trending in Telehealth: February 2025

Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

McDermott Will & Schulte

This Week in 340B: February 25 – March 3, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Hogan Lovells

JPM 2025 recap: Panelists discuss life sciences growth strategies, policy uncertainties, and promising regulatory opportunities

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In the wake of the 2024 U.S. elections, stakeholders in the life sciences and health care industry are intensely focused on the policy implications for global financial markets, investment strategies, and M&A opportunities....more

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

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On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

Mintz - Antitrust Viewpoints

PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry

On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more

Bass, Berry & Sims PLC

DOJ Brings Nationwide False Claims Act Lawsuit Against CVS for Alleged Violations of Controlled Substances Act

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On December 13, the U.S. Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit alleging that CVS Pharmacy Inc. and its subsidiaries improperly sought federal reimbursement for prescriptions filled in...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

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The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

ArentFox Schiff

The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need...

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Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more

Hogan Lovells

The increasing legalisation of French market access positions is confirmed

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The new amendments to the French framework agreement. The implementation of special hospital preparations and the amendment to the framework agreement concluded between the French professional organization of pharmaceutical...more

Smart & Biggar

CDA–AMC (formerly CADTH) announces several pilot projects, including Target Zero initiative

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CADTH is now known as Canada’s Drug Agency (CDA-AMC or CDA). Its mandate extends beyond CADTH’s mandate to include: improving the appropriate prescribing and use of medications; increasing pan-Canadian data collection and...more

McDermott Will & Schulte

Trending in Telehealth: May 14 – May 20, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

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