News & Analysis as of

Reimbursements Drug Pricing

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

Mintz - Health Care Viewpoints

Federal Court Temporarily Halts Iowa’s PBM Reform Law Amid Legal Challenges

On June 11, 2025, Iowa enacted Senate File 383 (the Act), a comprehensive bill aimed at regulating pharmacy benefit managers (PBMs) with the stated goals of increasing transparency, supporting independent pharmacies, and...more

Husch Blackwell LLP

DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know

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On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more

Quarles & Brady LLP

Part D Pharmacies Required to Enroll in Data Exchange Module to Help Drug Price Negotiation Cash Flow Issue

Quarles & Brady LLP on

On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more

Bass, Berry & Sims PLC

Wall Street and Industry React Favorably to CMS Medicare Advantage Rate Increase & Final Part C and D Rule for 2026

Bass, Berry & Sims PLC on

Two recent announcements from the Centers for Medicare & Medicaid Services (CMS) offer early indicators as to how the Trump administration, including CMS administrator Dr. Mehmet Oz, may approach the Medicare Advantage (MA)...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

Bressler, Amery & Ross, P.C.

The New Jersey Department of Banking & Insurance Issues Two Health-Related Insurance Bulletins Announcing Changes to the Law,...

On December 31, 2024, the New Jersey Department of Banking & Insurance (“Department”) issued two Bulletins, announcing changes to the law, effective January 1, 2025. Both Bulletins addressed health insurance. Bulletin, No....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

Mintz - Health Care Viewpoints

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

Wiley Rein LLP

Proposed State and Federal PBM Legislation: Is There Reason for Action Now?

Wiley Rein LLP on

Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more

Smart & Biggar

pCPA announces new three-year pricing initiative agreement for generic drugs with CGPA, appointment of Douglas Clark as its first...

Smart & Biggar on

The pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) have agreed to a new three-year pricing initiative for generic drugs, effective October 1, 2023. This agreement, which...more

J.S. Held

AHLA Takeaway: Healthcare Executives, Is Your House In Order?

J.S. Held on

Walking away from the American Health Law Association’s annual conference, I’m feeling energized from (re)connecting with friends and colleagues, inspired by the complex and transformational work being done throughout the...more

Epstein Becker & Green

Local Law Amends New York City Charter and Establishes an Office of Healthcare Accountability

On June 8, 2023, the New York City Council passed a bill focused on healthcare accountability, with the goal of increasing access to healthcare services for New Yorkers. Entitled the Healthcare Accountability & Consumer...more

Ballard Spahr LLP

Supreme Court’s SuperValu Decision: a Game-Changer for Assessing FCA Violations

Ballard Spahr LLP on

Summary - On June 1, 2023, the Supreme Court issued a landmark decision in False Claims Act cases. In United States ex rel. Schutte v. SuperValu Inc., it unanimously held that liability under the False Claims Act depends...more

McDermott Will & Emery

Proposed Legislation Would Require Greater Transparency and Disclosure from Hospitals, Reduce Reimbursement to Certain Off-Campus...

McDermott Will & Emery on

Two bills are moving in the United States House of Representatives that have implications for hospitals and health systems, with material changes proposed regarding pricing transparency requirements, identification and...more

ArentFox Schiff

Investigations Newsletter: Supreme Court Again Tightens FCA Intent, But Tricky Questions Linger

ArentFox Schiff on

The US Supreme Court brushed aside novel assertions from two pharmacy retailers on June 1 and ruled unanimously that False Claims Act liability hinges on whether defendants subjectively believed their claims were “false.” In...more

Davis Wright Tremaine LLP

Supreme Court Clarifies FCA Scienter Standard – Overturns 7th Circuit Decision

Ruling in case involving national retail pharmacies rejects the “objective reasonableness” standard for the False Claims Act - On June 1, 2023, the U.S. Supreme Court unanimously vacated the 7th Circuit's decision in U.S....more

American Conference Institute (ACI)

[Event] 21st Annual Rx Drug Pricing Boot Camp - May 4th - 5th, New York City, NY

The American Conference Institute is hosting the 21st Annual Rx Drug Pricing Boot Camp in New York. With both federal and state law makers engaging in greater scrutiny of prescription drug pricing, now is the time when...more

McDermott Will & Emery

This Week in 340B: February 2023 #2

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

King & Spalding

Court Rules on Retrospective Relief for 340B Hospitals Without Vacating CMS’s Rules

King & Spalding on

On January 10, 2023, Judge Contreras of the United States District Court for the District of Columbia ruled that CMS’s 340B drug reimbursement rates dating back to January 1, 2018, were unlawful and underpaid affected...more

Smart & Biggar

Innovative Medicines Canada proposes framework for innovative agreements for drug reimbursement

Smart & Biggar on

Pharmaceutical manufacturers in Canada often enter into Product Listing Agreements (PLA), particularly with public payors, to facilitate their drug being reimbursed. It is common for PLAs to take the form of a first dollar...more

Polsinelli

340B Hospital Reimbursement Update – Underpayments and the Need to Act Now

Polsinelli on

It has certainly been a year of ups and downs for 340B hospitals. While litigation continues in the manufacturer 340B price restriction space, and 340B hospitals continue to experience financial, legal and operational...more

K&L Gates LLP

Recent Developments to the 340B Drug Pricing Program

K&L Gates LLP on

In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effects of the Supreme Court’s decision earlier this year overturning 340B...more

Bass, Berry & Sims PLC

CMS Reverses 340B Payment Cuts for 2023 but Does Not Address Remedy for Prior Years

Bass, Berry & Sims PLC on

On November 3, the Centers for Medicare & Medicaid Services (CMS) issued an update to its Medicare Part B drug payment policy for hospitals participating in the 340B drug pricing program and reversed payment cuts in place...more

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